,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32342496,Efficacy and safety of nabiximols cannabinoid medicine for paediatric spasticity in cerebral palsy or traumatic brain injury: a randomized controlled trial.,"AIM
To assess the efficacy, safety, and tolerability of oromucosal nabiximols cannabinoid medicine as adjunct therapy for children with spasticity due to cerebral palsy/traumatic central nervous system injury with inadequate response to existing treatment.
METHOD
Overall, 72 patients (mean [SD] age 12y 4mo [3y 1mo], range 8-18y) were randomized at a ratio of 2:1 to receive nabiximols (n=47; 29 males, 18 females) or placebo (n=25; 15 males, 10 females) for 12 weeks (12 sprays/day max. based on clinical response/tolerability). The primary outcome was change from baseline in level of spasticity on a 0 to 10 Numerical Rating Scale (NRS), assessed by the primary caregiver at 12 weeks. Secondary outcomes included additional measures for spasticity, sleep quality, pain, health-related quality of life, comfort, depression, and safety.
RESULTS
There was no significant difference in the spasticity 0 to 10 NRS between nabiximols versus placebo groups after 12 weeks. No statistically significant differences were observed for any secondary endpoint. Adverse events were predominantly mild or moderate in severity; however, three cases of hallucinations were reported.
INTERPRETATION
Nabiximols was generally well tolerated; however, neuropsychiatric adverse events were observed. No significant reduction in spasticity with nabiximols treatment versus placebo was observed.
WHAT THIS PAPER ADDS
Oromucosal nabiximols is generally well tolerated by paediatric patients. However, three cases of hallucinations were observed, one of which involved auditory hallucinations and a suicide attempt. Oromucosal nabiximols versus placebo did not reduce cerebral palsy/central nervous system injury-related spasticity.",2020,There was no significant difference in the spasticity 0 to 10 NRS between nabiximols versus placebo groups after 12 weeks.,"['n=47; 29 males, 18 females) or', '72 patients (mean [SD] age 12y 4mo [3y 1mo], range 8-18y', 'paediatric patients', 'children with spasticity due to cerebral palsy/traumatic central nervous system injury', 'paediatric spasticity in cerebral palsy or traumatic brain injury']","['nabiximols cannabinoid medicine', 'nabiximols', 'oromucosal nabiximols cannabinoid medicine', 'placebo']","['spasticity 0', 'Adverse events', 'change from baseline in level of spasticity on a 0 to 10 Numerical Rating Scale (NRS', 'Efficacy and safety', 'spasticity', 'additional measures for spasticity, sleep quality, pain, health-related quality of life, comfort, depression, and safety', 'neuropsychiatric adverse events', 'cerebral palsy/central nervous system injury-related spasticity', 'efficacy, safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C1264238', 'cui_str': 'Injury of central nervous system'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1299004', 'cui_str': 'Oromucosal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C1264238', 'cui_str': 'Injury of central nervous system'}]",72.0,0.447635,There was no significant difference in the spasticity 0 to 10 NRS between nabiximols versus placebo groups after 12 weeks.,"[{'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': ""Department of Paediatric Neurosciences, Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Department of Paediatric Neurology, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Checketts', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Susie', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': ""Department of Paediatric Neurosciences, Evelina London Children's Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}]",Developmental medicine and child neurology,['10.1111/dmcn.14548']
1,32339280,Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.,,2020,,[],['laparoscopic umbilical hernia repair'],[],[],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia'}]",[],,0.413261,,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Affiliated Zhongda Hospital, Southeast University, Nanjing, China.'}]",The British journal of surgery,['10.1002/bjs.11604']
2,32339359,A Pilot Randomized Controlled Trial of the PTSD Coach App Following Motor Vehicle Crash-related Injury.,"OBJECTIVE
Posttraumatic stress disorder (PTSD) symptoms (PTSS) are common after minor injuries and can impair recovery. We sought to understand whether an evidence-based mobile phone application with self-help tools (PTSD Coach) could be useful to improve recovery after acute trauma among injured emergency department (ED) patients. This pilot study examined the feasibility, acceptability, and potential benefit of using PTSD Coach among acutely injured motor vehicle crash (MVC) patients.
METHODS
From September 2017 to September 2018, we recruited adult patients within 24 hours post-MVC from the EDs of two Level I trauma centers in the United States. We randomly assigned 64 injured adults to either the PTSD Coach (n = 33) or treatment as usual (TAU; n = 31) condition. We assessed PTSS and associated symptoms at 1 month (83% retained) and 3 months (73% retained) postenrollment.
RESULTS
Enrollment was feasible (74% of eligible subjects participated) but usability and engagement were low (67% used PTSD Coach at least once, primarily in week 1); 76% of those who used it rated the app as moderately to extremely helpful. No differences emerged between groups in PTSS outcomes. Exploratory analyses among black subjects (n = 21) indicated that those in the PTSD Coach condition (vs. TAU) reported marginally lower PTSS (95% CI = -0.30 to 37.77) and higher PTSS coping self-efficacy (95% CI = -58.20 to -3.61) at 3 months.
CONCLUSIONS
We demonstrated feasibility to recruit acutely injured ED patients into an app-based intervention study, yet mixed evidence emerged for the usability and benefit of PTSD Coach. Most patients used the app once and rated it favorably in regard to satisfaction with and helpfulness, but longitudinal engagement was low. This latter finding may explain the lack of overall effects on PTSS. Additional research is warranted regarding whether targeting more symptomatic patients and the addition of engagement and support features can improve efficacy.",2020,No differences emerged between groups in PTSS outcomes.,"['64 injured adults to either the', 'acute trauma among injured emergency department (ED) patients', 'acutely injured motor-vehicle crash (MVC) patients', 'From September 2017-September 2018', 'adult patients within 24 hours post-MVC from the EDs of two Level 1 trauma centers in the United States', 'Black subjects (n = 21']","['evidence-based mobile phone application with self-help tools (PTSD Coach', 'PTSD Coach']","['PTSS coping self-efficacy', 'PTSD symptoms (PTSS) and associated symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175845', 'cui_str': 'Motor vehicle'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557773', 'cui_str': 'Coach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}]",64.0,0.242411,No differences emerged between groups in PTSS outcomes.,"[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Pacella-LaBarbara', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Suffoletto', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Kuhn', 'Affiliation': 'the, Dissemination and Training Division, National Center for PTSD, Palo Alto, CA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'and the, Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Stephany', 'Initials': 'S', 'LastName': 'Jaramillo', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Repine', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Clifton W', 'Initials': 'CW', 'LastName': 'Callaway', 'Affiliation': 'From the, Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14000']
3,32339504,Long-Term Graft Patency After Off-Pump and On-Pump Coronary Artery Bypass: A CORONARY Trial Cohort.,"BACKGROUND
Randomized controlled trials have compared the early and midterm prognosis of on-pump coronary artery bypass grafting (CABG) and off-pump CABG. However the results are controversial, and there is limited information on graft patency and long-term outcomes.
METHODS
Between May 2007 and October 2011, 349 patients were randomized to off-pump or on-pump CABG as part of the CORONARY trial at Fuwai Hospital. The primary outcome was coronary bypass graft patency, which was assessed at a mean of 6.7 ± 1.7 years after surgery by multidetector computed tomography. A secondary endpoint was a composite outcome of death, nonfatal myocardial infarction, repeat coronary revascularization, or stroke; mean follow-up was 6.5 ± 1.7 years. Graft patency was compared between the off-pump and on-pump CABG treatment arms in 206 patients with follow-up computed tomography.
RESULTS
During the follow-up period 107 patients were in the off-pump CABG group and 99 in the on-pump group. These patients underwent a total of 723 grafts, and the overall rate of graft patency did not differ significantly between the off-pump and on-pump groups (87.4% vs 88.9%, P = .527). The patency rate of the posterior descending branch was lower than average. Higher incidences of mortality, nonfatal myocardial infarction, and repeat revascularization were found in the off-pump patients; however it did not reach significance.
CONCLUSIONS
There were no statistical differences in graft patency rates in off-pump versus on-pump CABG patients during long-term follow-up. The on-pump CABG group appeared to have a better long-term prognosis even with no statistical differences for the limited study population.",2020,On-pump CABG group appeared to offer a better long-term prognosis even with no statistical differences for the limited study population.,"['Betweeen', '107 patients in the off-pump CABG group and 99 in the on-pump group during the follow-up period', '206 patients with follow-up computed tomography', 'May 2007 and October 2011, 349 patients']","['pump or on-pump CABG', 'pump coronary artery bypass grafting (CABG) and off-pump CABG', 'Pump and On-Pump Coronary Artery Bypass']","['mortality, nonfatal myocardial infarction and repeat revascularization', 'coronary bypass graft patency', 'graft patency rates', 'patency rate of the posterior descending branch', 'overall rate of graft patency', 'composite outcome of death, nonfatal myocardial infarction, repeat coronary revascularization, or stroke; mean follow-up', 'Graft patency']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",349.0,0.140282,On-pump CABG group appeared to offer a better long-term prognosis even with no statistical differences for the limited study population.,"[{'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Dachuan', 'Initials': 'D', 'LastName': 'Gu', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Sipeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China. Electronic address: zhengzhe@fuwai.com.""}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.053']
4,32340524,Positive Health Beliefs and Blood Pressure Reduction in the DESERVE Study.,"Background There is growing recognition that positive health beliefs may promote blood pressure (BP) reduction, which is critical to stroke prevention but remains a persistent challenge. Yet, studies that examine the association between positive health beliefs and BP among stroke survivors are lacking. Methods and Results Data came from the DESERVE (Discharge Educational Strategies for Reduction of Vascular Events) study, a randomized controlled trial of a skills-based behavioral intervention to reduce vascular risk in a multiethnic cohort of 552 transient ischemic attack and mild/moderate stroke patients in New York City. The exposure was perception that people can protect themselves from having a stroke (ie, prevention self-efficacy) at baseline. The association between systolic BP (SBP) reduction at 12-month follow-up and self-efficacy was examined using linear regression adjusted for key confounders, overall and stratified by age, sex, race/ethnicity, and intervention trial arm. Approximately three quarters endorsed self-efficacy. These participants had, on average, 5.6 mm Hg greater SBP reduction compared with those who did not endorse it (95% CI, 0.5-10.7 mm Hg; P =0.032). Self-efficacy was significantly associated with greater SBP reduction, particularly among female versus male, younger versus older, and Hispanic versus non-Hispanic white patients. Sensitivity analysis adjusting for baseline SBP instead of elevated BP yielded no association between self-efficacy and SBP reduction, but showed sex differences in this association (women: β=5.3; 95% CI, -0.2 to 10.8; P =0.057; men: β=-3.3; 95% CI, -9.4 to 2.9; P =0.300; interaction P =0.064). Conclusions Self-efficacy was linked with greater SBP reduction among female stroke survivors. Targeted strategies to improve health beliefs after stroke may be important for risk factor management. REGISTRATION URL: https://www.clinicaltrials.gov; Unique identifier: NCT01836354.",2020,"Hg greater SBP reduction compared with those who did not endorse it (95% CI, 0.5-10.7 mm Hg; P =0.032).","['female versus male, younger versus older, and Hispanic versus non-Hispanic white patients', 'multiethnic cohort of 552 transient ischemic attack and mild/moderate stroke patients in New York City', 'female stroke survivors', 'participants had, on average, 5.6\xa0mm']",['skills-based behavioral intervention'],"['blood pressure (BP) reduction', 'Positive Health Beliefs and Blood Pressure Reduction', 'self-efficacy and SBP reduction', 'vascular risk', 'systolic BP (SBP) reduction', 'SBP reduction', 'Self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517794', 'cui_str': '5.6'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.111864,"Hg greater SBP reduction compared with those who did not endorse it (95% CI, 0.5-10.7 mm Hg; P =0.032).","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Goldmann', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Jacoby', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Finfer', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Appleton', 'Affiliation': 'Department of Population Health New York University Langone Health New York NY.'}, {'ForeName': 'Nina S', 'Initials': 'NS', 'LastName': 'Parikh', 'Affiliation': 'Department of Social and Behavioral Sciences School of Global Public Health New York University New York NY.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Boden-Albala', 'Affiliation': 'Program in Public Health, Susan and Henry Samueli College of Health Sciences University of California, Irvine CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014782']
5,32340530,Cardiovascular Risk and Resilience Among Black Adults: Rationale and Design of the MECA Study.,"Background Cardiovascular disease incidence, prevalence, morbidity, and mortality have declined in the past several decades; however, disparities persist among subsets of the population. Notably, blacks have not experienced the same improvements on the whole as whites. Furthermore, frequent reports of relatively poorer health statistics among the black population have led to a broad assumption that black race reliably predicts relatively poorer health outcomes. However, substantial intraethnic and intraracial heterogeneity exists; moreover, individuals with similar risk factors and environmental exposures are often known to experience vastly different cardiovascular health outcomes. Thus, some individuals have good outcomes even in the presence of cardiovascular risk factors, a concept known as resilience. Methods and Results The MECA (Morehouse-Emory Center for Health Equity) Study was designed to investigate the multilevel exposures that contribute to ""resilience"" in the face of risk for poor cardiovascular health among blacks in the greater Atlanta, GA, metropolitan area. We used census tract data to determine ""at-risk"" and ""resilient"" neighborhoods with high or low prevalence of cardiovascular morbidity and mortality, based on cardiovascular death, hospitalization, and emergency department visits for blacks. More than 1400 individuals from these census tracts assented to demographic, health, and psychosocial questionnaires administered through telephone surveys. Afterwards, ≈500 individuals were recruited to enroll in a clinical study, where risk biomarkers, such as oxidative stress, and inflammatory markers, endothelial progenitor cells, metabolomic and microRNA profiles, and subclinical vascular dysfunction were measured. In addition, comprehensive behavioral questionnaires were collected and ideal cardiovascular health metrics were assessed using the American Heart Association's Life Simple 7 measure. Last, 150 individuals with low Life Simple 7 were recruited and randomized to a behavioral mobile health (eHealth) plus health coach or eHealth only intervention and followed up for improvement. Conclusions The MECA Study is investigating socioenvironmental and individual behavioral measures that promote resilience to cardiovascular disease in blacks by assessing biological, functional, and molecular mechanisms. REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT03308812.",2020,"Notably, blacks have not experienced the same improvements on the whole as whites.","['blacks in the greater Atlanta, GA, metropolitan area', 'Black Adults', '≈500 individuals', '150 individuals with low Life Simple 7 were recruited and randomized to a']",['behavioral mobile health (eHealth) plus health coach or eHealth only intervention'],"['oxidative stress, and inflammatory markers, endothelial progenitor cells, metabolomic and microRNA profiles, and subclinical vascular dysfunction', ' Cardiovascular disease incidence, prevalence, morbidity, and mortality', 'Cardiovascular Risk and Resilience']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",,0.0394992,"Notably, blacks have not experienced the same improvements on the whole as whites.","[{'ForeName': 'Shabatun J', 'Initials': 'SJ', 'LastName': 'Islam', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Jeong Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Topel', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics Rollins School of Public Health Emory University Atlanta GA.'}, {'ForeName': 'Mahasin S', 'Initials': 'MS', 'LastName': 'Mujahid', 'Affiliation': 'Division of Epidemiology School of Public Health University of California Berkeley CA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sims', 'Affiliation': 'Department of Medicine University of Mississippi Medical Center Jackson MS.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mubasher', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Ejaz', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Morgan-Billingslea', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Department of Hematology and Oncology Winship Cancer Institute Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Uppal', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing Emory University Atlanta GA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pemu', 'Affiliation': 'Department of Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Searles', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Baltrus', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Tené T', 'Initials': 'TT', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology Rollins School of Public Health Emory University Atlanta GA.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine Morehouse School of Medicine Atlanta GA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015247']
6,32342562,Randomized Clinical Trial of First-Line Genome Sequencing in Pediatric White Matter Disorders.,"OBJECTIVE
Genome sequencing (GS) is promising for unsolved leukodystrophies, but its efficacy has not been prospectively studied.
METHODS
A prospective time-delayed crossover design trial of GS to assess the efficacy of GS as a first-line diagnostic tool for genetic white matter disorders took place between December 1, 2015 and September 27, 2017. Patients were randomized to receive GS immediately with concurrent standard of care (SoC) testing, or to receive SoC testing for 4 months followed by GS.
RESULTS
Thirty-four individuals were assessed at interim review. The genetic origin of 2 patient's leukoencephalopathy was resolved before randomization. Nine patients were stratified to the immediate intervention group and 23 patients to the delayed-GS arm. The efficacy of GS was significant relative to SoC in the immediate (5/9 [56%] vs 0/9 [0%]; Wild-Seber, p < 0.005) and delayed (control) arms (14/23 [61%] vs 5/23 [22%]; Wild-Seber, p < 0.005). The time to diagnosis was significantly shorter in the immediate-GS group (log-rank test, p = 0.04). The overall diagnostic efficacy of combined GS and SoC approaches was 26 of 34 (76.5%, 95% confidence interval = 58.8-89.3%) in <4 months, greater than historical norms of <50% over 5 years. Owing to loss of clinical equipoise, the trial design was altered to a single-arm observational study.
INTERPRETATION
In this study, first-line GS provided earlier and greater diagnostic efficacy in white matter disorders. We provide an evidence-based diagnostic testing algorithm to enable appropriate clinical GS utilization in this population. ANN NEUROL 2020;88:264-273.",2020,"The time to diagnosis was significantly shorter in the immediate-GS group (log rank test, p=0.04).","['genetic white matter disorders took place between 12/01/2015 - 09/27/2017', 'Pediatric White Matter Disorders', 'Nine patients stratified to the immediate intervention group and 23 patients to the delayed-GS arm']","['GS immediately with concurrent standard of care (SoC) testing, or to receive SoC testing for four months followed by GS']","['time to diagnosis', 'diagnostic efficacy', 'overall diagnostic efficacy']","[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",34.0,0.0792432,"The time to diagnosis was significantly shorter in the immediate-GS group (log rank test, p=0.04).","[{'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Vanderver', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Departments of Neurology and Neurosurgery, Pediatrics, and Human Genetics, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Helman', 'Affiliation': 'Institute for Molecular Bioscience, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Sherbini', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Boeck', 'Affiliation': 'Child Neurology Consultants of Austin, Austin, Texas, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Cohn', 'Affiliation': 'Family Medicine, Broadlands Family Practice at Ashburn, Ashburn, Virginia, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Collins', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Demarest', 'Affiliation': 'Department of Neurology, Anschutz Medical Campus, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Dobbins', 'Affiliation': 'Walter Reed National Military Medical Center, Bethesda, Maryland, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Emrick', 'Affiliation': 'Department of Molecular and Human Genetics, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Fraser', 'Affiliation': ""Division of Genetics and Metabolism, Rare Disease Institute, Children's National Hospital, Washington, District of Columbia, USA.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Masser-Frye', 'Affiliation': ""Rady Children's Hospital, San Diego, California, USA.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hayward', 'Affiliation': 'Department of Pediatrics, Kaiser Oakland, Oakland, California, USA.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Karmarkar', 'Affiliation': ""Department of Neurology, Le Bonheur Children's Hospital, Memphis, Tennessee, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Keller', 'Affiliation': 'Division of Neurology, Department of Pediatrics, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Mirrop', 'Affiliation': 'Pediatric Associates of Austin, Austin, Texas, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Mitchell', 'Affiliation': ""Division of Neurology, Children's Hospital of Los Angeles, Los Angeles, California, USA.""}, {'ForeName': 'Sheel', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Clinical Neurology, Washington University Clinical Associates, St Louis, Missouri, USA.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Sherr', 'Affiliation': 'Department of Neurology, University of California, San Francisco School of Medicine, San Francisco, California, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'van Haren', 'Affiliation': 'Department of Neurology, Stanford University Medical Center, Stanford, California, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Waters', 'Affiliation': 'Pediatric Associates of Stockton, Stockton, California, USA.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Wilson', 'Affiliation': 'Division of Pediatric Neurology, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Zhorne', 'Affiliation': 'Stead Family Department of Pediatrics, Carver College of Medicine, University of Iowa Health Care, Iowa City, Iowa, USA.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Schiffmann', 'Affiliation': 'Institute of Metabolic Disease, Baylor Scott & White Research Institute, Dallas, Texas, USA.'}, {'ForeName': 'Marjo S', 'Initials': 'MS', 'LastName': 'van der Knaap', 'Affiliation': 'Department of Child Neurology, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Pizzino', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Dubbs', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Cas', 'Initials': 'C', 'LastName': 'Simons', 'Affiliation': 'Institute for Molecular Bioscience, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Taft', 'Affiliation': 'Illumina, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25757']
7,32342662,A Combined Health Action Process Approach and mHealth Intervention to Increase Non-Sedentary Behaviours in Office-Working Adults-A Randomised Controlled Trial.,"BACKGROUND
Office-working adults represent an at-risk population for high levels of sedentary behaviour (SB), which has been associated with an increased risk for numerous chronic diseases. This study examined the effectiveness of a Health Action Process Approach (HAPA) based planning intervention augmented with tailored text messages to reduce workplace sitting time (primary outcome) and increase specific non-SBs (i.e. standing time, walking time, stretching time, break frequency, break duration). A secondary purpose was to examine relationships among HAPA volitional constructs and sedentary and non-SBs.
METHODS
Full-time office workers (M age = 45.18 ± 11.33 years) from Canada were randomised into either a HAPA intervention (n = 29) or control (n = 31) condition. Workplace sitting time, time spent in specific non-SBs, and HAPA volitional constructs were assessed at baseline, weeks 2, 4, 6 (post-intervention), and 8 (follow-up).
RESULTS
Significant group by time interaction effects, that favoured the intervention group, were found for sitting time (p = .003, ɳ p 2 = .07), standing time (p = .019, ɳ p 2 = .05), and stretching time (p = .001, ɳ p 2 = .08) as well as for action planning (p < .001, ɳ p 2 = .20), coping planning (p < .001, ɳ p 2 = .18), and action control (p < .001, ɳ p 2 = .15). Significant correlations (p < .05) were also found between the HAPA constructs and time spent sitting, standing, walking, as well as break frequency.
CONCLUSIONS
Augmenting a HAPA-based planning intervention with text messages can reduce workplace sitting time in office workers.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03461926.",2020,"Significant correlations (p < .05) were also found between the HAPA constructs and time spent sitting, standing, walking, as well as break frequency.
","['Office-working adults represent an at-risk population for high levels of sedentary behaviour (SB', '45.18\xa0±\xa011.33\xa0years) from Canada', 'Full-time office workers (M age \xa0']","['HAPA intervention', 'Health Action Process Approach (HAPA) based planning intervention', 'Combined Health Action Process Approach and mHealth Intervention', 'HAPA-based planning intervention with text messages']","['specific non-SBs (i.e. standing time, walking time, stretching time, break frequency, break duration', 'standing time', 'action control', 'sitting time', 'HAPA constructs and time spent sitting, standing, walking, as well as break frequency', 'workplace sitting time', 'Workplace sitting time, time spent in specific non-SBs, and HAPA volitional constructs', 'coping planning', 'time interaction effects', 'stretching time']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242444', 'cui_str': 'Populations at Risk'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.062468,"Significant correlations (p < .05) were also found between the HAPA constructs and time spent sitting, standing, walking, as well as break frequency.
","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rollo', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12201']
8,32346686,"Clinical Research of the Application of Bone Turnover Markers in Monitoring the Short-Term Therapeutic Efficacy of Vitamin D in Postmenopausal Osteoporotic women in Harbin, China.","BACKGROUND
The incidence of osteoporosis (OP) is increasing year by year. researches have shown that there was an intense link between the vitamin D (VitD) status and the efficacy of zoledronate (ZOL) in patients with osteoporosis. Since VitD is related to the geogen, its promotion effect on zoledronate has regional specificity.
AIM
Combining dual-energy X-ray and bone turnover markers (BTM) to explore the VitD level in postmenopausal osteoporosis patients in Harbin and monitor its effect on the anti-osteoporosis effect of ZOL.
METHODS
A total of 120 patients with postmenopausal osteoporosis (PMO) were enrolled .These patients were divided into two groups with 25(OH)D levels = 10ng/ml as a critical point, and each group was randomly divided into experimental groups and control groups). All of the patients were conducted 5 mg ZOL. Then the experimental group was given calcitriol and calcium carbonate, and the control group was only given calcium carbonate. BTM were measured at baseline, 24h, 3 months and 6 months. We also measured bone mineral density (BMD) of bilateral hips (TH BMD) and lumbar spine (LS BMD) at baseline and 6 months.
RESULTS
The VitD deficiency rates of the patients enrolled were 84.1%. There was an inverse relationship between the baseline level of VitD and the serum levels of P1NP / β-CTX, (r=-0.452,p=0.00; r=-0.225, p=0.01). Comparing with baseline, the level of serum P1NP,β-CTX in each group declined significantly after the treatment (P<0.05). The mean decreasing rates of P1NP and β-CTX in the both experimental groups were significantly higher than that of the corresponding control groups at the same time point (P<0.05), after 6 months of medication. Both TH BMD and LS BMD at 6 months increased significantly. The increase rate of LS BMD in the high VitD experimental group was significantly higher than the other three groups (P<0.05), the increase rates of TH BMD in the low VitD control group were significantly lower than the other three groups (P<0.05).
CONCLUSIONS
The levels of serum VitD in the patients enrolled in this study were generally low. VitD could increase the therapeutic effect of ZOL on osteoporosis.",2020,"Comparing with baseline, the level of serum P1NP,β-CTX in each group declined significantly after the treatment (P<0.05).","['patients with osteoporosis', 'Postmenopausal Osteoporotic women in Harbin, China', '120 patients with postmenopausal osteoporosis (PMO) were enrolled .These', 'postmenopausal osteoporosis patients in Harbin']","['Vitamin D', 'calcitriol and calcium carbonate', 'ZOL', 'zoledronate (ZOL', 'calcium carbonate', 'dual-energy X-ray and bone turnover markers (BTM']","['rate of LS BMD', 'BTM', 'level of serum P1NP,β-CTX', 'baseline level of VitD and the serum levels of P1NP / β-CTX', 'rates of TH BMD', 'levels of serum VitD', 'bone mineral density (BMD) of bilateral hips (TH BMD) and lumbar spine (LS BMD', 'TH BMD and LS BMD', 'mean decreasing rates of P1NP and β-CTX', 'VitD deficiency rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]",120.0,0.0130508,"Comparing with baseline, the level of serum P1NP,β-CTX in each group declined significantly after the treatment (P<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Yansong Wang, Department of Spine Surgery, the First Affiliated Hospital of Harbin Medical University, Harbin, China, wangyans1975@163.com.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1362-z']
9,32348036,"Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab in Healthy Adult Subjects.","Dupilumab is a fully human monoclonal antibody directed against the interleukin (IL)-4 receptor α subunit (IL-4Rα) of IL-4 heterodimeric type I and type II receptors that mediate IL-4/IL-13 signaling through this pathway. Blockade of these receptors broadly suppresses type 2 inflammation associated with atopic/allergic diseases, including atopic dermatitis and asthma. Six phase 1 studies investigated the pharmacokinetics, pharmacodynamics, safety, and tolerability of dupilumab in healthy subjects. Two randomized, double-blind, placebo-controlled, sequential studies assessed safety and tolerability of single escalating dupilumab doses administered intravenously or subcutaneously (one included various racial groups, and one included exclusively Japanese subjects); 3 randomized, parallel-group, single-dose studies compared the pharmacokinetic profiles of different dupilumab products and formulations after single subcutaneous doses; and one study assessed dupilumab administered as fast versus slow subcutaneous injections. Dupilumab concentrations in serum were measured in all studies, and total immunoglobulin E (IgE) and thymus- and activation-regulated chemokine (TARC) concentrations were measured in 2 studies as pharmacodynamic markers. Across the phase 1 studies, dupilumab exhibited target-mediated pharmacokinetics consisting of parallel linear and nonlinear elimination, with the target-mediated phase highly dominated by nonlinearity at lower drug concentrations. Systemic exposure and tolerability of dupilumab were consistent irrespective of differences in product, formulation, or racial background. Dupilumab reduced circulating concentrations of total IgE and TARC, indicating blockade of IL-4Rα-mediated signaling. Dupilumab had a favorable safety profile across the wide range of doses administered. Together, these findings support the continued development and use of dupilumab in treatment of type 2 diseases.",2020,"Dupilumab reduced circulating concentrations of total IgE and TARC, indicating blockade of IL-4Rα-mediated signaling.","['various racial groups, and one included exclusively Japanese subjects', 'healthy subjects', 'Healthy Adult Subjects']","['α subunit (IL-4Rα) of IL-4 heterodimeric type', 'dupilumab administered as fast versus slow subcutaneous injections', 'placebo']","['circulating concentrations of total IgE and TARC', 'total immunoglobulin E (IgE) and thymus- and activation-regulated chemokine (TARC) concentrations', 'Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Dupilumab', 'safety and tolerability', 'Systemic exposure and tolerability of dupilumab', 'pharmacokinetics, pharmacodynamics, safety, and tolerability', 'Dupilumab concentrations in serum']","[{'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0539535', 'cui_str': 'CCL17 protein, human'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.158021,"Dupilumab reduced circulating concentrations of total IgE and TARC, indicating blockade of IL-4Rα-mediated signaling.","[{'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Sanofi Genzyme, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Radin', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Hamilton', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Kajiwara', 'Affiliation': 'Sanofi KK, Tokyo, Japan.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Davis', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Sanofi KK, Tokyo, Japan.'}, {'ForeName': 'Setsuo', 'Initials': 'S', 'LastName': 'Hasegawa', 'Affiliation': 'Sekino Clinical Pharmacology Clinic, Tokyo, Japan.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'A Thomas', 'Initials': 'AT', 'LastName': 'DiCioccio', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Yongtao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Kovalenko', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortemann-Renon', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Swanson', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.798']
10,32343631,Improving well-being after traumatic brain injury through volunteering: a randomized controlled trial.,"OBJECTIVE
To evaluate the efficacy of a novel intervention facilitating volunteer activity to improve well-being in individuals with traumatic brain injury (TBI).
DESIGN
Randomized two-arm controlled trial, with a wait-list control condition (ClinicalTrials.gov NCT#01728350).
SETTING
Community-based setting.
PARTICIPANTS
Seventy-four community-dwelling individuals at least 1-year post TBI, who had completed inpatient or outpatient TBI rehabilitation.
INTERVENTIONS
A novel intervention, HOPE - Helping Others through Purpose and Engagement, involving orientation/training and a 3-month volunteer placement for the participant, along with training for community agencies regarding TBI.
MAIN OUTCOME MEASURE(S
): Satisfaction With Life Scale (SWLS); Flourishing Scale (FS); Brief Symptom Inventory-18 (BSI-18); Scale of Positive and Negative Experience (SPANE); Purpose in Life subscale (one of six in the Ryff Scale of Psychological Well-Being - 54 item version).
RESULTS
There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group. There were no significant treatment effects on the additional secondary measures of well-being, although they trended in a positive direction.
CONCLUSIONS
This study supports our primary hypothesis that individuals who take part in a volunteer intervention will demonstrate greater psychological well-being in comparison to a control group.",2020,There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group.,"['Participants : Seventy-four community-dwelling individuals at least \ufeff1-year post TBI, who had completed inpatient or outpatient TBI rehabilitation', 'individuals with traumatic brain injury (TBI']",['novel intervention facilitating volunteer activity'],"['BSI-18); Scale of Positive and Negative Experience (SPANE); Purpose in Life subscale (one of six in the Ryff Scale of Psychological', 'life satisfaction (SWLS) and self-perceived success (FS', 'Main \ufeffoutcome \ufeffmeasure(s ): Satisfaction With Life Scale (SWLS); Flourishing Scale (FS); Brief Symptom Inventory-18']","[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",74.0,0.0623567,There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Payne', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Hawley', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Morey', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Ketchum', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Philippus', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Sevigny', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Harrison-Felix', 'Affiliation': 'Research Department, Craig Hospital , Englewood, CO, USA.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Diener', 'Affiliation': 'Psychology Department, University of Utah , Salt Lake City, UT, USA.'}]",Brain injury,['10.1080/02699052.2020.1752937']
11,32343882,Association of High Serum Interleukin-6 Levels With Severe Progression of Rheumatoid Arthritis and Increased Treatment Response Differentiating Sarilumab From Adalimumab or Methotrexate in a Post Hoc Analysis.,"OBJECTIVE
The development of biomarkers to guide treatment decisions is a major research focus in rheumatoid arthritis (RA). Patients with RA have elevated interleukin-6 (IL-6) levels; however, the utility of IL-6 as a predictor of treatment response is unclear. This study was undertaken to investigate, by post hoc analysis, whether baseline IL-6 levels are predictive of sarilumab treatment responses in 2 phase III studies.
METHODS
Serum IL-6 concentrations were measured in patients with RA prior to receiving sarilumab 200 mg (n = 148) or adalimumab 40 mg (n = 152) every 2 weeks (in the MONARCH trial; ClinicalTrials.gov identifier: NCT02332590) or sarilumab 150 mg, sarilumab 200 mg, or placebo every 2 weeks plus methotrexate (MTX) (n = 401, n = 396, and n = 397, respectively) (in the MOBILITY trial; ClinicalTrials.gov identifier: NCT01061736). Efficacy and patient-reported outcomes were compared between and within groups according to IL-6 tertile using linear and logistic regression.
RESULTS
In MONARCH, patients with high baseline IL-6 levels (all ≥3 times the upper limit of normal; n = 100) had higher disease activity at baseline than those with low IL-6 levels (n = 100). The magnitude of clinical improvement over 24 weeks with sarilumab versus adalimumab was greater in patients with high compared to those with low baseline IL-6 levels. In MOBILITY, compared to patients with low IL-6 levels (n = 397), patients with high IL-6 levels (n = 398) had higher disease activity and joint damage at baseline, were more likely to have joint progression, and had less clinical improvement over 52 weeks' treatment with placebo plus MTX compared to sarilumab 150 mg or 200 mg plus MTX. Baseline IL-6 and C-reactive protein levels were both predictive of outcomes. Safety profiles were similar between defined IL-6 tertiles.
CONCLUSION
IL-6 may be a prognostic marker of disease progression and severity, and patients with high IL-6 levels may be likely to benefit from sarilumab compared to adalimumab or MTX. Prospective validation is warranted to confirm the results of these post hoc analyses.",2020,The magnitude of clinical improvement over 24 weeks with sarilumab versus adalimumab was greater in patients with high baseline IL-6 than patients with low baseline IL-6.,"['patients with RA prior to receiving sarilumab 200 mg (n = 148) or', 'patients with high IL-6 (n = 398']","['adalimumab', 'adalimumab or methotrexate', 'placebo+methotrexate', 'Adalimumab or Methotrexate', 'sarilumab 150 or 200 mg+methotrexate']","['elevated interleukin-6 (IL-6) levels', 'Baseline IL-6 and C-reactive protein', 'disease activity', 'Safety profiles', 'disease activity and joint damage', 'Serum IL-6 concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C3885145', 'cui_str': 'sarilumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.184548,The magnitude of clinical improvement over 24 weeks with sarilumab versus adalimumab was greater in patients with high baseline IL-6 than patients with low baseline IL-6.,"[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Boyapati', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Schwartzman', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Msihid', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Cardiff University School of Medicine, Cardiff, UK.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Stanford University Medical Center, Palo Alto, California.'}, {'ForeName': 'Gerd R', 'Initials': 'GR', 'LastName': 'Burmester', 'Affiliation': 'Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Lam', 'Affiliation': 'Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sadeh', 'Affiliation': 'Sanofi, Bridgewater, New Jersey.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Neil M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41299']
12,32344133,Unilateral or Bilateral Percutaneous Endoscopic Debridement and Lavage Treatment for Lumbar Spinal Tuberculosis.,"OBJECTIVE
To compare the clinical outcome between bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment for lumbar spine tuberculosis (LST).
METHODS
A total of 40 patients with LST who underwent either bilateral PEDL (group A) or unilateral PEDL (group B) were reviewed. Perioperative parameters were assessed by operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage. Clinical outcomes were evaluated in the Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). All patients were followed-up for at least 18 months after treatment.
RESULTS
The average operative time and intraoperative fluoroscopy time were increased in group A compared with those in group B. There was no statistical significance between the 2 groups in postoperative continuous irrigation and vacuum drainage days. The ESR and CRP curves in the 2 groups showed a similar trend during 18-month follow-up. The VAS and ODI in the 2 groups significantly decreased 6 and 18 months postsurgery. There was no significant difference in the incidence of complication between the 2 groups.
CONCLUSIONS
Two procedures yielded comparable and satisfactory results. Unilateral PEDL showed shorter operative time and decreased intraoperative fluoroscopy times compared with bilateral PEDL. We suggest the use of unilateral PEDL rather than bilateral PEDL in the treatment of LST.",2020,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"['lumbar spinal tuberculosis', 'A total of 40 patients with LST who underwent either', 'lumbar spine tuberculosis (LST']","['unilateral PEDL', 'bilateral PEDL', 'bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment', 'Unilateral or bilateral percutaneous endoscopic debridement and lavage treatment']","['intraoperative fluoroscopy times', 'ESR and CRP curves', 'Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR) and C-reactive protein(CRP', 'VAS and ODI', 'average operative time and the intraoperative fluoroscopy times', 'incidence of complication', 'operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage', 'shorter operative time']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0041330', 'cui_str': 'Tuberculosis of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",40.0,0.0250191,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"[{'ForeName': 'Dongying', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China; Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: docweiminfan@126.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}]",World neurosurgery,['10.1016/j.wneu.2020.04.132']
13,32345990,Effects of β 2 -receptor stimulation by indacaterol in chronic heart failure treated with selective or non-selective β-blockers: a randomized trial.,"Alveolar β 2 -receptor blockade worsens lung diffusion in heart failure (HF). This effect could be mitigated by stimulating alveolar β 2 -receptors. We investigated the safety and the effects of indacaterol on lung diffusion, lung mechanics, sleep respiratory behavior, cardiac rhythm, welfare, and exercise performance in HF patients treated with a selective (bisoprolol) or a non-selective (carvedilol) β-blocker. Study procedures were performed before and after indacaterol and placebo treatments according to a cross-over, randomized, double-blind protocol in forty-four patients (27 on bisoprolol and 17 on carvedilol). No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2 slope and lower maximal P ET CO 2 during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2 31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2 36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively). In carvedilol, indacaterol was associated with a higher peak heart rate (119 ± 34 vs. 113 ± 30 bpm, with indacaterol and placebo) and a lower prevalence of hypopnea during sleep (3.8 [0.0;6.3] vs. 5.8 [2.9;10.5] events/hour, with indacaterol and placebo). Inhaled indacaterol is well tolerated in HF patients, it does not influence lung diffusion, and, in bisoprolol, it increases ventilation response to exercise.",2020,"No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2 slope and lower maximal P ET CO 2 during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2 31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2 36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively).","['forty-four patients (27 on bisoprolol and 17 on', 'chronic heart failure treated with selective or non-selective β-blockers', 'heart failure (HF', 'HF patients treated with a', 'HF patients']","['carvedilol', 'Inhaled indacaterol', 'indacaterol', 'indacaterol and placebo', 'carvedilol, indacaterol', 'selective (bisoprolol) or a non-selective (carvedilol) β-blocker', 'placebo']","['peak heart rate', 'lung diffusion, lung mechanics, sleep respiratory behavior, cardiac rhythm, welfare, and exercise performance', 'hypopnea during sleep']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0054836', 'cui_str': 'carvedilol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",,0.162873,"No differences between indacaterol and placebo were observed in the whole population except for a significantly higher VE/VCO 2 slope and lower maximal P ET CO 2 during exercise with indacaterol, entirely due to the difference in the bisoprolol group (VE/VCO 2 31.8 ± 5.9 vs. 28.5 ± 5.6, p < 0.0001 and maximal P ET CO 2 36.7 ± 5.5 vs. 37.7 ± 5.8 mmHg, p < 0.02 with indacaterol and placebo, respectively).","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Contini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Spadafora', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Barbieri', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gugliandolo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Salvioni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Magini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Apostolo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Palermo', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Alimento', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy.'}, {'ForeName': 'Piergiuseppe', 'Initials': 'P', 'LastName': 'Agostoni', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milano, Italy. piergiuseppe.agostoni@ccfm.it.'}]",Scientific reports,['10.1038/s41598-020-62644-1']
14,32367114,Effects of Mu-Opiate Receptor Gene Polymorphism rs1799971 (A118G) on the Antidepressant and Dissociation Responses in Esketamine Nasal Spray Clinical Trials.,"BACKGROUND
At ketamine and esketamine doses at which antidepressant doses are achieved, these agents are relatively selective, noncompetitive, N-methyl-D-aspartate receptor antagonists. However, at substantially higher doses, ketamine has shown mu-opioid receptor (MOR-gene symbol: OPRM1) agonist effects. Preliminary clinical studies showed conflicting results on whether naltrexone, a MOR antagonist, blocks the antidepressant action of ketamine. We examined drug-induced or endogenous MOR involvement in the antidepressant and dissociative responses to esketamine by assessing the effects of a functional single nucleotide polymorphism rs1799971 (A118G) of OPRM1, which is known to alter MOR agonist-mediated responses.
METHODS
Participants with treatment-resistant depression from 2 phase III, double-blind, controlled trials of esketamine (or placebo) nasal spray plus an oral antidepressant were genotyped for rs1799971. Participants received the experimental agents twice weekly for 4 weeks. Antidepressant responses were rated using the change in Montgomery-Åsberg Depression Rating Scale (MADRS) score on days 2 and 28 post-dose initiation, and dissociative side effects were assessed using the Clinician-Administered Dissociative-States Scale at 40 minutes post-dose on days 1 and 25.
RESULTS
In the esketamine + antidepressant arm, no significant genotype effect of single nucleotide polymorphism rs1799971 (A118G) on MADRS score reductions was detected on either day 2 or 28. By contrast, in the antidepressant + placebo arm, there was a significant genotype effect on MADRS score reductions on day 2 and a nonsignificant trend on day 28 towards an improvement in depression symptoms in G-allele carriers. No significant genotype effects on dissociative responses were detected.
CONCLUSIONS
Variation in rs1799971 (A118G) did not affect the antidepressant response to esketamine + antidepressant. Antidepressant response to antidepressant + placebo was increased in G-allele carriers, compatible with previous reports that release of endorphins/enkephalins may play a role in mediating placebo effect.
TRIAL REGISTRATION
NCT02417064 and NCT02418585; www.clinicaltrials.gov.",2020,In the esketamine+AD arm no significant genotype effect of SNP rs1799971 (A118G) on MADRS score reductions was detected on either day 2 or day 28.,"['Participants with treatment-resistant depression from two phase 3, double-blind, controlled trials of']","['naltrexone', 'ketamine', 'Mu-Opiate Receptor Gene Polymorphism rs1799971', 'esketamine or placebo nasal spray plus an oral antidepressant (AD']","['Antidepressant response to AD+placebo', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'dissociative responses', 'depression symptoms', 'MADRS score reductions']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1436808', 'cui_str': 'OPRM1 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.227838,In the esketamine+AD arm no significant genotype effect of SNP rs1799971 (A118G) on MADRS score reductions was detected on either day 2 or day 28.,"[{'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Saad', 'Affiliation': 'Janssen Research & Development, San Diego, California.'}, {'ForeName': 'Derrek', 'Initials': 'D', 'LastName': 'Hibar', 'Affiliation': 'Genentech, Inc, South San Francisco, California.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Fedgchin', 'Affiliation': 'Janssen Research & Development, Titusville, New Jersey.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Popova', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Furey', 'Affiliation': 'Janssen Research & Development, San Diego, California.'}, {'ForeName': 'Jaskaran B', 'Initials': 'JB', 'LastName': 'Singh', 'Affiliation': 'Janssen Research & Development, San Diego, California.'}, {'ForeName': 'Hartmuth', 'Initials': 'H', 'LastName': 'Kolb', 'Affiliation': 'Janssen Research & Development, San Diego, California.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research & Development, San Diego, California.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Janssen Research & Development, San Diego, California.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa030']
15,32348638,Utilization trends of respiratory medication in premature infants discharged on home oxygen therapy.,"BACKGROUND
Roughly half of all extremely preterm infants will be diagnosed with bronchopulmonary dysplasia (BPD), and a third will be discharged on home oxygen therapy (HOT). To date, there have been no studies that have examined the relationship between respiratory medication utilization in infants with BPD on HOT.
METHODS
The recorded home oximetry trial was a multicenter, randomized trial comparing two home oxygen management strategies in premature infants. Infants were enrolled at first outpatient pulmonary or neonatal intensive care unit (NICU) follow-up visit with a pulmonary component. Respiratory medication prescriptions and dosage were collected from time of enrollment through 6 months after HOT discontinuation. Patients were seen monthly while on HOT and at 1, 3, and 6 months after successful discontinuation.
RESULTS
During protocol visits, 174 (89%) infants had respiratory medications documented. Respiratory medication use was higher at initial follow-up visit compared with NICU discharge and decreased at the final 6-month follow-up visit. Infants who received inhaled steroids (IS) before weaning had mean HOT duration of 138 days (range: 24-562 days); infants who received IS after weaning had shorter mean HOT duration (55 days, range: 21-264). In time-to-event analysis the no IS group and the postwean group differed significantly (χ 2 1 = 8.1; P = .004). NICU clinics gave a total of 35 prescriptions to 43 patients, an average of 0.8 per patient, while the pulmonary clinics gave 837 prescriptions to 153 patients, or 5.5 per patient (P < .0001).
CONCLUSION
Respiratory prescribing patterns for infants on HOT are highly variable. Utilization of IS was not associated with shorter duration of HOT.",2020,In time-to-event analysis the no IS group and the postwean group differed significantly (χ 2 1 = 8.1; P = .004).,"['infants with BPD', 'Infants were enrolled at first outpatient pulmonary or neonatal intensive care unit (NICU) follow-up visit with a pulmonary component', 'premature infants', 'premature infants discharged on home oxygen therapy']",['inhaled steroids (IS'],"['mean HOT duration', 'shorter duration of HOT']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1960973', 'cui_str': 'Home oxygen therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}]",,0.10114,In time-to-event analysis the no IS group and the postwean group differed significantly (χ 2 1 = 8.1; P = .004).,"[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'White', 'Affiliation': 'Division of Neonatology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Berenson', 'Affiliation': 'School of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Mannan', 'Affiliation': 'Division of Neonatology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': 'Henry A', 'Initials': 'HA', 'LastName': 'Feldman', 'Affiliation': ""Division of Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Rhein', 'Affiliation': 'Division of Neonatology, University of Massachusetts Memorial Medical Center, Worcester, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric pulmonology,['10.1002/ppul.24735']
16,32348739,Limited Efficacy of Thrombolytics for Pump Thrombosis in Durable Left Ventricular Assist Devices.,"BACKGROUND
This study reports a single-center experience with thrombolytics for left ventricular assist device (LVAD) pump thrombosis.
METHODS
Adults undergoing continuous-flow LVAD implantation between 2004 and 2018 at a single center were reviewed and those with pump thrombosis were identified. Primary outcomes included 1-year survival and success rates of thrombolytic therapy. Secondary outcomes included posttreatment adverse events, freedom from major bleeding at 1 year, and freedom from stroke at 1-year follow-up.
RESULTS
A total of 341 patients underwent LVAD implantation and 10.8% (n = 37) developed pump thrombosis. Of those 37, 26 received initial thrombolytic therapy (70.2%), 5 underwent direct pump exchange (13.5%), and 6 received only intravenous heparin owing to presentation with acute stroke or severe multiorgan failure (16.2%). Successful treatment was achieved in 11.5% of patients receiving thrombolytics (n = 3). Early adverse events after thrombolytic therapy included major bleeding in 11.5% (n = 3) and new stroke in 7.7% (n = 2). Most patients undergoing thrombolytic therapy underwent subsequent device exchange (69.2%; n = 18). Overall survival in patients with pump thrombosis after treatment was 96.8% at 30 days, 78.9% at 90 days, and 63.1% at 1 year. Freedom from major bleeding and stroke at 1 year was 74.2% and 87.2%, respectively.
CONCLUSIONS
In this single-center experience of thrombolytics for pump thrombosis in LVAD patients, there was limited efficacy; most patients required subsequent pump exchange. Combined with the risk for major bleeding or stroke with thrombolysis, this underscores the importance of further refining patient selection for direct pump exchange in those presenting with pump thrombosis.",2020,"The overall survival in patients with pump thrombosis following treatment was 96.8% at 30-days, 78.9% at 90-days, and 63.1% at 1-year.","['LVAD patients', '341 patients underwent', 'Adults undergoing continuous-flow LVAD implantation between 2004-2018 at a single center were reviewed and those with pump thrombosis identified']","['initial thrombolytic therapy', 'thrombolytic therapy', 'heparin', 'LVAD implantation']","['post-treatment adverse events, freedom from major bleeding at 1-year and freedom from stroke at 1-year follow-up', 'pump thrombosis', 'overall survival', '1-year survival and success rates of thrombolytic therapy', 'major bleeding', 'new stroke']","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}]",341.0,0.223001,"The overall survival in patients with pump thrombosis following treatment was 96.8% at 30-days, 78.9% at 90-days, and 63.1% at 1-year.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seese', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Keebler', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Floyd', 'Initials': 'F', 'LastName': 'Thoma', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: kilica2@upmc.edu.'}]",The Annals of thoracic surgery,['10.1016/j.athoracsur.2020.03.061']
17,32349025,The Effect of Cell Phones on Attention and Learning in Nursing Students.,"The use of cell phones can have a negative effect on nursing students' academic performance. The purpose of this study was to identify the effects that problematic cell phone use and nomophobia have on learning in nursing students. A quasi-experimental study was carried out among nursing students, with a control group (n = 61, 49.2%) and an experimental group (n = 63, 50.8%). The experimental group left their cell phones, in sound or vibration mode, as they normally kept them, on a table located in the corner of the classroom. Both groups showed higher-than-average levels of nomophobia at the beginning of the class. As for problematic cell phone use and attention, it was found that there were statistically significant differences in both cases (U = 1355.500, Z = -2.830, P = .005; U = 1449.000, Z = -2.363, P = .018, respectively), and the experimental group had higher average scores, as well as in those related to knowledge. A relationship has been found between nomophobia and problematic cell phone use. Students who do not have access to their cell phones during class perceive more problematic cell phone usage, in addition to paying closer attention during class. Because of this, it is important to create policies and norms restricting cell phone use during all types of academic training among nursing students.",2020,"As for problematic cell phone use and attention, it was found that there were statistically significant differences in both cases (U = 1355.500, Z = -2.830, P = .005; U = 1449.000, Z = -2.363, P = .018, respectively), and the experimental group had higher average scores, as well as in those related to knowledge.","['nursing students, with a control group (n = 61, 49.2%) and an experimental group (n = 63, 50.8', 'nursing students', 'Nursing Students']",['Cell Phones'],[],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1136359', 'cui_str': 'Cellular Phone'}]",[],,0.0135394,"As for problematic cell phone use and attention, it was found that there were statistically significant differences in both cases (U = 1355.500, Z = -2.830, P = .005; U = 1449.000, Z = -2.363, P = .018, respectively), and the experimental group had higher average scores, as well as in those related to knowledge.","[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': 'Author Affiliations: Department of Nursing, Physiotherapy and Medicine, Faculty of Health Sciences (Dr Gutiérrez-Puertas and Ms Gutiérrez-Puertas) and Department of Nursing, Physiotherapy and Medicine, Faculty of Health Sciences, Research Group of Health Sciences CTS-451 (Drs Márquez-Hernández, Granados-Gámez, and Aguilera-Manrique), University of Almeria, Spain.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Márquez-Hernández', 'Affiliation': ''}, {'ForeName': 'Vanesa', 'Initials': 'V', 'LastName': 'Gutiérrez-Puertas', 'Affiliation': ''}, {'ForeName': 'Genoveva', 'Initials': 'G', 'LastName': 'Granados-Gámez', 'Affiliation': ''}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Aguilera-Manrique', 'Affiliation': ''}]","Computers, informatics, nursing : CIN",['10.1097/CIN.0000000000000626']
18,32349059,Two Doses of Tranexamic Acid Reduce Blood Loss in Primary Posterior Lumbar Fusion Surgery: A Randomized-controlled Trial.,"PURPOSE
Tranexamic acid (TXA) has been widely used in hip and knee arthroplasty to reduce perioperative blood loss and blood transfusion, but the dosage and efficacy of TXA in posterior lumbar spinal surgery are not fully clear. The aim of this study was to investigate the efficacy and safety of TXA and to determine whether 2 doses of TXA could reduce the blood loss in primary single-segment or double-segment posterior lumbar fusion surgery.
MATERIALS AND METHODS
A total of 150 patients with lumbar degenerative disease undergoing posterior lumbar interbody fusion surgery between October 2017 and February 2019 were randomized to 3 groups. Group A was treated with 0.9% normal saline solution without TXA, group B was treated with a 15 mg/kg loading dose intravenous infusion 30 minutes before surgery, and group C was treated with a 15 mg/kg loading dose intravenous infusion 30 minutes before surgery; then, the same dose was administered again 3 hours later. The assessed outcomes were the operation time, the total blood loss, the hidden blood loss, postoperative drainage, blood transfusions, incidence of venous thromboembolism, and incision infection.
RESULTS
The total blood loss, the hidden blood loss, and postoperative drainage were the lowest in group C. The amount of intraoperative blood loss was similar among the 3 groups. The hemoglobin and hematocrit values of the third postoperative day were the highest in group C. No significant differences in the incidence of complications and adverse events from TXA use were observed among the 3 groups. The use of TXA, the operation time, and the number of fusion segments were identified as risk factors related to total blood loss.
CONCLUSION
Two doses of TXA significantly reduced the total blood loss, the hidden blood loss and postoperative drainage, and decreased hemoglobin and hematocrit drop in patients undergoing posterior lumbar fusion without increasing the risk of complications.",2020,"Two doses of TXA significantly reduced the total blood loss, the hidden blood loss and postoperative drainage, and decreased hemoglobin and hematocrit drop in patients undergoing posterior lumbar fusion without increasing the risk of complications.","['Primary Posterior Lumbar Fusion Surgery', 'primary single-segment or double-segment posterior lumbar fusion surgery', '150 patients with lumbar degenerative disease undergoing posterior lumbar interbody fusion surgery between October 2017 and February 2019']","['Tranexamic Acid', 'Tranexamic acid (TXA', 'TXA', 'normal saline solution without TXA']","['total blood loss, the hidden blood loss, and postoperative drainage', 'operation time, the total blood loss, the hidden blood loss, postoperative drainage, blood transfusions, incidence of venous thromboembolism, and incision infection', 'efficacy and safety', 'hemoglobin and hematocrit values', 'intraoperative blood loss', 'total blood loss, the hidden blood loss and postoperative drainage, and decreased hemoglobin and hematocrit', 'blood loss']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1285162', 'cui_str': 'Degenerative disorder'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",150.0,0.0915538,"Two doses of TXA significantly reduced the total blood loss, the hidden blood loss and postoperative drainage, and decreased hemoglobin and hematocrit drop in patients undergoing posterior lumbar fusion without increasing the risk of complications.","[{'ForeName': 'Xianren', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': ""Department of Cardiology, The Second Affiliated Hospital of Shandong First Medical University, Tai'an, Shandong Province, People's Republic of China.""}, {'ForeName': 'Dongya', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province.'}, {'ForeName': 'Jibin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province.'}, {'ForeName': 'Kaijin', 'Initials': 'K', 'LastName': 'Guo', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu Province.'}]",Clinical spine surgery,['10.1097/BSD.0000000000000999']
19,32358608,Online Acceptance and Commitment Therapy for People with Painful Diabetic Neuropathy in the United Kingdom: A Single-Arm Feasibility Trial.,"OBJECTIVE
This study aimed to assess the feasibility of online Acceptance and Commitment Therapy for painful diabetic neuropathy in the United Kingdom and to determine if a larger randomized controlled trial testing treatment efficacy is justified.
METHODS
Participants with painful diabetic neuropathy were recruited online and from hospital services. This was a single-arm study in which all participants received online Acceptance and Commitment Therapy. Participants completed questionnaires at baseline and three months post-treatment. Primary feasibility outcomes were recruitment, retention, and treatment completion rates. Secondary outcomes were pre- to post-treatment effects on pain outcomes and psychological flexibility.
RESULTS
Of 225 potentially eligible participants, 30 took part in this study. Regarding primary feasibility outcomes, the treatment completion and follow-up questionnaire completion rates were 40% and 100%, respectively. Generally, at baseline those who completed the treatment, compared with those who did not, had better daily functioning and higher psychological flexibility. With respect to secondary outcomes, results from the completers group showed clinically meaningful effects at post-treatment for 100% of participants for pain intensity and pain distress, 66.7% for depressive symptoms, 58.3% for functional impairment, 41.7% for cognitive fusion, 66.7% for committed action, 58.3% for self-as-context, and 41.7% for pain acceptance.
CONCLUSIONS
This preliminary trial suggests feasibility of recruitment and follow-up questionnaire completion rates, supporting planning for a larger randomized controlled trial. However, treatment completion rates did not achieve the prespecified feasibility target. Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.",2020,Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.,"['Of 225 potentially eligible participants', 'Participants with painful diabetic neuropathy were recruited online and from hospital services', 'people with painful diabetic neuropathy', 'People with Painful Diabetic Neuropathy in the United Kingdom']","['Online Acceptance and Commitment Therapy', 'online Acceptance and Commitment Therapy']","['pain intensity and pain distress', 'treatment completion and follow-up questionnaire completion rates', 'daily functioning and higher psychological flexibility', 'clinically meaningful effects', 'depressive symptoms', 'recruitment, retention, and treatment completion rates', 'pain outcomes and psychological flexibility']","[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",225.0,0.261831,Changes to the treatment content and delivery may enhance the feasibility of online Acceptance and Commitment Therapy for people with painful diabetic neuropathy on a larger scale.,"[{'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Kioskli', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Scott', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Winkley', 'Affiliation': ""King's College London, Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Godfrey', 'Affiliation': ""Health Psychology Section, Psychology Department, Institute of Psychiatry Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'McCracken', 'Affiliation': 'Uppsala University, Psychology Department, Uppsala, Sweden.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa110']
20,32352714,Abdominal Pain Response to Rifaximin in Patients With Irritable Bowel Syndrome With Diarrhea.,"INTRODUCTION
Abdominal pain is the principal symptom of irritable bowel syndrome (IBS). This analysis examined abdominal pain response in adults with IBS with diarrhea (IBS-D) receiving the nonsystemic antibiotic rifaximin.
METHODS
In the Targeted Nonsystemic Antibiotic Rifaximin Gut-Selective Evaluation of Treatment for IBS-D 3 trial, adults with IBS-D received open-label rifaximin 550 mg 3 times daily for 2 weeks, followed by the 4-week post-treatment phase assessing abdominal pain and stool consistency response. Responders were followed for up to 18 additional weeks; patients with recurrence were randomly assigned to receive two 2-week courses of double-blind rifaximin 550 mg 3 times daily or placebo, separated by 10 weeks. Analyses evaluated mean weekly improvements from baseline (e.g., ≥30%, ≥40%, and ≥50%) in abdominal pain during the 4-week post-repeat-treatment phases.
RESULTS
Of the 2,438 evaluable patients, 1,384 (56.8%) had abdominal pain response to open-label rifaximin (≥30% improvement from baseline in the mean weekly abdominal pain score during ≥2 of the first 4 weeks post-treatment). Weekly decrease (improvement) in responders' mean abdominal pain score (scale range, 0-10) from baseline ranged from -2.6 to -3.3 points during the 18-week follow-up. After the first double-blind repeat treatment, a significantly higher percentage of rifaximin-treated patients were abdominal pain responders (53.9% [172/319]) vs placebo (44.4% [134/302], P = 0.02), with similar results after the second repeat treatment (52.9% [155/293] vs 44.7% [123/275], respectively, P = 0.047). A significantly higher percentage of rifaximin-treated patients were weekly abdominal pain responders for ≥50% of the 18-week double-blind repeat treatment phase (47.9% [138/288] vs 35.9% [97/270], P = 0.004).
DISCUSSION
Rifaximin is efficacious in improving abdominal pain in adults with IBS-D.",2020,"Weekly decrease (improvement) in responders' mean abdominal pain score (scale range, 0-10) from baseline ranged from -2.6 to -3.3 points during the 18-week follow-up.","['adults with IBS with diarrhea (IBS-D) receiving the nonsystemic antibiotic rifaximin', 'adults with IBS-D received', 'Patients', 'adults with IBS-D', 'Responders were followed for up to 18 additional weeks; patients with recurrence', '2,438 evaluable patients, 1,384 (56.8%) had']","['Rifaximin', 'open-label rifaximin', 'double-blind rifaximin 550 mg 3 times daily or placebo', 'placebo']","['abdominal pain and stool consistency response', 'abdominal pain response', 'mean weekly abdominal pain score', 'abdominal pain responders', 'Abdominal Pain Response', 'abdominal pain', ""responders' mean abdominal pain score""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348898', 'cui_str': 'Irritable bowel syndrome with diarrhea'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C2710454', 'cui_str': 'rifaximin 550 MG'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2438.0,0.378706,"Weekly decrease (improvement) in responders' mean abdominal pain score (scale range, 0-10) from baseline ranged from -2.6 to -3.3 points during the 18-week follow-up.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Beth Israel Deaconess Medical Center, Department of Medicine, Division of Gastroenterology, Boston, Massachusetts, USA.'}, {'ForeName': 'Satish S C', 'Initials': 'SSC', 'LastName': 'Rao', 'Affiliation': 'Department of Medicine, Division of Gastroenterology/Hepatology, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Heimanson', 'Affiliation': 'Salix Pharmaceuticals, Department of Medical Affairs, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pimentel', 'Affiliation': 'Medically Associated Science and Technology Program, Cedars-Sinai Medical Center, Los Angeles, California, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000144']
21,32355959,Corticospinal-motor neuronal plasticity promotes exercise-mediated recovery in humans with spinal cord injury.,"Rehabilitative exercise in humans with spinal cord injury aims to engage residual neural networks to improve functional recovery. We hypothesized that exercise combined with non-invasive stimulation targeting spinal synapses further promotes functional recovery. Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury were randomly assigned to 10 sessions of exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS. In an additional experiment, we tested the effect of PCMS without exercise in 13 individuals with spinal cord injury with similar characteristics. During PCMS, 180 pairs of stimuli were timed to have corticospinal volleys evoked by transcranial magnetic stimulation over the primary motor cortex arrive at corticospinal-motor neuronal synapses of upper- or lower-limb muscles (depending on the injury level), 1-2 ms before antidromic potentials were elicited in motor neurons by electrical stimulation of a peripheral nerve. Participants exercised for 45 min after all protocols. We found that the time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test decreased on average by 20% after all protocols. However, the amplitude of corticospinal responses elicited by transcranial magnetic stimulation and the magnitude of maximal voluntary contractions in targeted muscles increased on overage by 40-50% after PCMS combined or not with exercise but not after sham-PCMS combined with exercise. Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains. Our findings indicate that targeted non-invasive stimulation of spinal synapses might represent an effective strategy to facilitate exercise-mediated recovery in humans with different degrees of paralysis and levels of spinal cord injury.",2020,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","['humans with spinal cord injury', '13 individuals with spinal cord injury with similar characteristics', 'Twenty-five individuals with chronic incomplete cervical, thoracic, and lumbar spinal cord injury']","['PCMS without exercise', 'exercise combined with paired corticospinal-motor neuronal stimulation (PCMS) or sham-PCMS', 'Corticospinal-motor neuronal plasticity promotes exercise', 'Rehabilitative exercise', 'exercise combined with sham-PCMS']","['time to complete subcomponents of the Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and the 10-m walk test', 'behavioural and physiological effects']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0457848', 'cui_str': 'Segment of lumbar spinal cord'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.223458,"Notably, behavioural and physiological effects were preserved 6 months after the intervention in the group receiving exercise with PCMS but not in the group receiving exercise combined with sham-PCMS, suggesting that the stimulation contributed to preserve exercise gains.","[{'ForeName': 'Hang Jin', 'Initials': 'HJ', 'LastName': 'Jo', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}, {'ForeName': 'Monica A', 'Initials': 'MA', 'LastName': 'Perez', 'Affiliation': 'University of Miami, Department of Neurological Surgery, The Miami Project to Cure Paralysis, and Bruce W. Carter Department of Veterans Affairs Medical Center, Miami, FL, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa052']
22,32368942,Isokinetic Strength Comparison of Tuberosity Fractures of the Proximal Fifth Metatarsal Treated With Elastic Bandage vs Cast.,"BACKGROUND
The aim of this study was to compare the strength of injured and healthy ankle muscle as well as functional and clinical outcomes between patients with proximal fifth metatarsal tuberosity fractures who received elastic bandage treatment and those who received cast immobilization.
METHODS
Sixty-five patients who presented to our clinic between February 2018 and April 2019 were randomly divided into 2 groups: 33 received elastic bandages (group 1) and 32 received cast immobilization (group 2). All patients were scheduled for follow-up appointments at our clinic after 2, 4, 8, 12, and 24 weeks. Visual analog scale-foot and ankle (VAS-FA) score, time missed from work, and using assistive devices were recorded as clinical outcomes. Both ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque) were measured using an isokinetic dynamometer for each group and were compared with those of the healthy extremities.
RESULTS
The mean missed work was 11.3 days in group 1 and 27.6 days in group 2. Groups 1 and 2 used assistive devices for a mean of 6.7 and 16.2 days, respectively ( P = .001). Group 1 had a significantly higher VAS-FA score at the 2nd, 4th, and 8th week of follow-up compared with group 2, and no significant differences were observed at the time of injury and at the 12th and 24th weeks. The muscle strength deficits in group 1 were present at the 4th week, whereas those in the cast immobilization group were determined at the 4th and 8th weeks in all muscles. During the 12th and 24th week of follow-up, no significantly differences in both extremities were observed between the groups.
CONCLUSION
Elastic bandage treatment was better than cast immobilization in terms of preserving ankle muscle strength, clinical outcomes, and functional scores regardless of the degree of fracture displacement. Moreover, the present study emphasized that cast immobilization offered no advantages in this fracture treatment.
LEVEL OF EVIDENCE
Level I, prognostic randomized controlled trial.",2020,"Both ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque) were measured using an isokinetic dynamometer for each group and were compared with those of the healthy extremities.
","['Sixty-five patients who presented to our clinic between February 2018 and April 2019', 'patients with proximal fifth metatarsal tuberosity fractures who received']","['ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque', 'elastic bandage treatment and those who received cast immobilization', 'Elastic Bandage vs Cast', 'Elastic bandage', 'cast immobilization', 'elastic bandages']","['VAS-FA score', 'mean missed work', 'Visual analog scale-foot and ankle (VAS-FA) score, time missed from work, and using assistive devices', 'muscle strength deficits']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0459705', 'cui_str': 'Fifth metatarsal structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1283330', 'cui_str': 'Absenteeism at work'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",65.0,0.0314114,"Both ankle plantarflexion-dorsiflexion and inversion-eversion muscle strengths (peak torque) were measured using an isokinetic dynamometer for each group and were compared with those of the healthy extremities.
","[{'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Bayram', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Alper Şükrü', 'Initials': 'AŞ', 'LastName': 'Kendirci', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Doğan', 'Initials': 'D', 'LastName': 'Kıral', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Türker', 'Initials': 'T', 'LastName': 'Şahinkaya', 'Affiliation': 'Department of Sports Medicine, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Ekinci', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sefa Giray', 'Initials': 'SG', 'LastName': 'Batıbay', 'Affiliation': 'Department of Orthopedics and Traumatology, Ankara Occupational and Environmental Diseases Hospital, Ankara, Turkey.'}, {'ForeName': 'Turgut', 'Initials': 'T', 'LastName': 'Akgül', 'Affiliation': 'Department of Orthopedics and Traumatology, Istanbul University Faculty of Medicine, Istanbul, Turkey.'}]",Foot & ankle international,['10.1177/1071100720916429']
23,32358086,177 Lu-EB-PSMA Radioligand Therapy with Escalating Doses in Patients with Metastatic Castration-Resistant Prostate Cancer.,"This study was designed to assess the safety and therapeutic response to 177 Lu-labeled Evans blue-modified prostate-specific membrane antigen (PSMA) 617 (EB-PSMA-617) treatment with escalating doses in patients with metastatic castration-resistant prostate cancer. Methods: With institutional review board approval and informed consent, patients were randomly divided into 3 groups: group A ( n = 10) was treated with a 1.18 ± 0.09 GBq dose of 177 Lu-EB-PSMA. Group B ( n = 10) was treated with a 2.12 ± 0.19 GBq dose of 177 Lu-EB-PSMA. Group C ( n = 8) was treated with a 3.52 ± 0.58 GBq dose of 177 Lu-EB-PSMA. Eligible patients received up to 3 cycles of 177 Lu-EB-PSMA therapy, at 8-wk intervals. Results: Because of disease progression or bone marrow suppression, 4 of 10, 5 of 10, and 5 of 8 patients completed 3 cycles of therapy as planned in groups A, B, and C, respectively. The prostate-specific antigen response was correlated with treatment dose, and the prostate-specific antigen disease control rates were higher in groups B (70%) and C (75%) than in group A (10%) ( P = 0.007), but no correlation between groups B and C was found. 68 Ga-PSMA PET/CT showed a response in all treatment groups; however, there was no significant difference among the 3 groups. A hematologic toxicity study found that platelets decreased more in groups B and C than in group A and that grade 4 thrombocytopenia occurred in 2 (25.0%) patients in group C. No serious nephritic or hepatic side effects were observed. Conclusion: This study demonstrated that a 2.12-GBq dose of 177 Lu-EB-PSMA seems to be safe and adequate in tumor treatment. Further investigations with an increased number of patients are warranted.",2020,"The prostate-specific antigen (PSA) response was correlated with treatment dose, with PSA disease control rates in Group B (70%) and C (75%) being higher than that in Group A (10%) ( P = 0.007), but no correlation between Group B and Group C was found. ","['patients with metastatic castration-resistant prostate cancer', 'patients with metastatic castration-resistant prostate cancer (mCRPC']",['177 Lu-EB-PSMA radioligand therapy'],"['prostate-specific antigen (PSA) response', 'PSA disease control rates', 'Grade 4 thrombocytopenia', 'serious nephritic or hepatic side effects', 'Hematologic toxicity', 'disease progression or bone marrow suppression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}]",10.0,0.0136767,"The prostate-specific antigen (PSA) response was correlated with treatment dose, with PSA disease control rates in Group B (70%) and C (75%) being higher than that in Group A (10%) ( P = 0.007), but no correlation between Group B and Group C was found. ","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zang', 'Affiliation': 'Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Qingxing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Sui', 'Affiliation': 'Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Rongxi', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Jacobson', 'Affiliation': 'Laboratory of Molecular Imaging and Nanomedicine, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, Maryland; and.'}, {'ForeName': 'Xinrong', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Nuclear Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Laboratory of Molecular Imaging and Nanomedicine, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, Maryland; and pumcfxr@126.com chen9647@gmail.com 13611093752@163.com.'}]","Journal of nuclear medicine : official publication, Society of Nuclear Medicine",['10.2967/jnumed.120.242263']
24,32362147,A longitudinal investigation of the efficacy of online expressive writing interventions for Hispanic students exposed to traumatic events: competing theories of action.,"Objective: Although expressive writing (EW) appears efficacious for treating a range of posttraumatic stress (PTS) symptoms including diagnosed PTSD, little is known about its efficacy when offered online and for ethnic/cultural minority populations such as Hispanic individuals. The current study examined the longitudinal effects of two online EW tasks for treating PTS symptoms in a Hispanic student sample. Design: Seventy-one participants who had experienced a traumatic event were randomly assigned to either an emotion-focused (EM) writing group or a fact-focused (FC) writing group and completed online writing sessions for three consecutive days. Participants completed online assessments at 1-week, 1-month, and 3-month follow-ups. The PTSD Checklist-DSM-5 version was used to assess PTS symptoms. Results: Both groups reported statistically significant reductions in severity of PTS symptoms at 1-week follow-up with the EM group demonstrating statistically significantly greater symptom reductions than the FC group. Differential longitudinal effects over the 3-month follow-up periods were found for some PTS domains, with the EM group showing superior improvements relative to the FC group. Conclusion: EW delivered online can be useful for Hispanic individuals with PTS symptoms following traumatic life events. Further, the current findings align with an inhibitory learning model for explaining EW's mechanism of action.",2020,Both groups reported statistically significant reductions in severity of PTS symptoms at 1-week follow-up with the EM group demonstrating statistically significantly greater symptom reductions than the FC group.,"['Hispanic student sample', 'Design: Seventy-one participants who had experienced a traumatic event', 'Hispanic individuals with PTS symptoms following traumatic life events', 'Hispanic students exposed to traumatic events']","['online expressive writing interventions', 'online EW tasks', 'expressive writing (EW', 'emotion-focused (EM) writing group or a fact-focused (FC) writing group and completed online writing sessions']","['severity of PTS symptoms', 'symptom reductions']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",71.0,0.0293413,Both groups reported statistically significant reductions in severity of PTS symptoms at 1-week follow-up with the EM group demonstrating statistically significantly greater symptom reductions than the FC group.,"[{'ForeName': 'Michiyo', 'Initials': 'M', 'LastName': 'Hirai', 'Affiliation': 'University of Texas Rio Grande Valley, Edinburg, TX, USA.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Dolma', 'Affiliation': 'Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Vernon', 'Affiliation': 'Florida Atlantic University, Jupiter, FL, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Clum', 'Affiliation': 'Virginia Polytechnic Institute and State University, Blacksburg, VA, USA.'}]",Psychology & health,['10.1080/08870446.2020.1758324']
25,32367737,Exploring factors influencing recruitment results of nurses recruiting diabetes patients for a randomized controlled trial.,"BACKGROUND
Effective recruitment of patients by health professionals is challenging but pivotal to the success of clinical trials. Many trials fail to include the required number of participants, which affects the power of the study, generalizability of results, and timely dissemination of positive outcomes. Existing research is inconclusive regarding factors influencing recruitment results, and most research does not focus on perceptions of recruiting health professionals themselves. Therefore, thorough evaluations of recruitment facilitators and barriers in trials are needed in order to optimize future patient recruitment in trials. We observed divergent recruitment results among nurses who recruited diabetes patients to our trial, which examined the effectiveness of an eHealth programme. Therefore, we aimed to describe nurses' recruitment results and related shifts over time, and to qualitatively explore factors influencing nurses' recruitment results.
METHODS
Nurses' recruitment results and related temporal shifts were derived from trial data (NTR6840). Based on their recruitment results, nurses were categorized as non-, low-, medium-, or high-recruiters. Subsequently, a subset of nurses per group participated in an individual semi-structured telephone interview. Interviews were analysed using NVivo software, applying an inductive coding approach.
RESULTS
Ninety-six nurses participated in our trial and recruited on average seven patients (range: 0-32). Fifteen nurses did not recruit any patients. Most patients were recruited close to recruitment onset. Nurses who did not recruit patients close to recruitment onset generally ended up recruiting no patients. Data show a relatively high number of early recruited patients that progressively declined over time. High-recruiters were generally successful throughout the entire recruitment period. Recruitment facilitators and barriers comprised organizational, study, patient, and especially recruiter characteristics. Contrary to non- and low-recruiters, medium- and high-recruiters reported more in-depth knowledge about the study and trial requirements, expressed more personal participation-related benefits and fewer barriers, and incorporated more recruitment activities, reminders, and barrier-focused coping strategies.
CONCLUSION AND IMPLICATIONS
To optimize patient recruitment to clinical trials, suggested intervention targets include the continued inclusion of recruiters after initial recruitment onset and the encouragement of early recruitment success. A personalized approach may aid recruiters to become and remain successful. Primarily, it is important to provide recruiters with sufficient information on trial requirements and to address salient benefits for participation in the trial, both for themselves and for their patients. Finally, teaching recruiters skills on how to overcome barriers may further enhance motivation and recruitment capacities.",2020,"Contrary to non- and low-recruiters, medium- and high-recruiters reported more in-depth knowledge about the study and trial requirements, expressed more personal participation-related benefits and fewer barriers, and incorporated more recruitment activities, reminders, and barrier-focused coping strategies.
","['nurses recruiting diabetes patients', 'nurses who recruited diabetes patients', 'patients by health professionals', 'Ninety-six nurses participated in our trial and recruited on average seven patients (range: 0-32']",[],[],"[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",[],[],96.0,0.133276,"Contrary to non- and low-recruiters, medium- and high-recruiters reported more in-depth knowledge about the study and trial requirements, expressed more personal participation-related benefits and fewer barriers, and incorporated more recruitment activities, reminders, and barrier-focused coping strategies.
","[{'ForeName': 'Stan', 'Initials': 'S', 'LastName': 'Vluggen', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Ciska', 'Initials': 'C', 'LastName': 'Hoving', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Vonken', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Nicolaas C', 'Initials': 'NC', 'LastName': 'Schaper', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}]","Clinical trials (London, England)",['10.1177/1740774520914609']
26,32365359,"Rifabutin-Based Triple Therapy (RHB-105) for Helicobacter pylori Eradication: A Double-Blind, Randomized, Controlled Trial.","BACKGROUND
Although consensus supports eradication of Helicobacter pylori infections, antimicrobial resistance has substantially reduced eradication rates with most current therapies.
OBJECTIVE
To assess the effectiveness of a novel rifabutin-based therapy (RHB-105) for H pylori eradication.
DESIGN
Phase 3, double-blind trial (ERADICATE Hp2). (ClinicalTrials.gov: NCT03198507).
SETTING
55 clinical research sites in the United States.
PARTICIPANTS
455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection.
INTERVENTION
RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole, 120 mg), given as 4 capsules every 8 hours for 14 days.
MEASUREMENTS
Between-group difference for H pylori eradication rate, demonstrated by 13 C urea breath test 4 weeks after treatment, analyzed by using the χ 2 test.
RESULTS
In the intention-to-treat population, the eradication rate was higher with RHB-105 than with the active comparator (228 vs. 227 patients, respectively; 83.8% [95% CI, 78.4% to 88.0%] vs. 57.7% [95% CI, 51.2% to 64.0%]; P < 0.001). Eradication rates were unaffected by resistance to clarithromycin or metronidazole. No rifabutin resistance was detected. The most commonly reported adverse events (incidence ≥5%) were diarrhea (10.1% with RHB-105 vs. 7.9% with active comparator), headache (7.5% vs. 7.0%), and nausea (4.8% vs. 5.3%).
LIMITATION
Persons of Asian descent were excluded because of their higher prevalence of poor cytochrome P450 2C19 metabolizers.
CONCLUSION
These findings suggest potential for RHB-105 as first-line empirical H pylori therapy, addressing an unmet need in the current environment of increasing antibiotic resistance.
PRIMARY FUNDING SOURCE
RedHill Biopharma Ltd.",2020,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"['Participants\n\n\n455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection', 'Helicobacter pylori Eradication', 'Limitation\n\n\nPersons of Asian descent']","['novel rifabutin-based therapy (RHB-105', 'RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole', 'Rifabutin-Based Triple Therapy (RHB-105', 'metronidazole', 'clarithromycin']","['headache', 'diarrhea', 'rifabutin resistance', 'eradication rate', 'Eradication rates', 'adverse events', 'nausea', 'eradication rates', 'H pylori eradication rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0205386', 'cui_str': 'Descending'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",455.0,0.422929,Eradication rates were unaffected by resistance to clarithromycin or metronidazole.,"[{'ForeName': 'David Y', 'Initials': 'DY', 'LastName': 'Graham', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Yamil', 'Initials': 'Y', 'LastName': 'Canaan', 'Affiliation': 'Jesscan Medical Research, Miami, Florida (Y.C.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Maher', 'Affiliation': 'BI Research Center, Houston, Texas (J.M.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Wiener', 'Affiliation': 'GW Research, Inc., Chula Vista, California (G.W.).'}, {'ForeName': 'Kristina G', 'Initials': 'KG', 'LastName': 'Hulten', 'Affiliation': 'Baylor College of Medicine, Houston, Texas (D.Y.G., K.G.H.).'}, {'ForeName': 'Ira N', 'Initials': 'IN', 'LastName': 'Kalfus', 'Affiliation': 'Independent Consultant to Pharmaceutical companies, New York, New York (I.N.K.).'}]",Annals of internal medicine,['10.7326/M19-3734']
27,32367340,Comparison of High-Dose Rosuvastatin Versus Low-Dose Rosuvastatin Plus Ezetimibe on Carotid Atherosclerotic Plaque Inflammation in Patients with Acute Coronary Syndrome.,"We compared the effects of ezetimibe/rosuvastatin 10/5 mg versus rosuvastatin 20 mg on carotid atherosclerotic plaque inflammation measured by 18 FDG PET/CT. Fifty patients with acute coronary syndrome (ACS) were randomly assigned to the ezetimibe/rosuvastatin 10/5 mg and rosuvastatin 20 mg groups. The primary outcome was the percent change in the target-to-background ratio (TBR) of the index vessel in the most diseased segment (MDS), as assessed by 18 FDG PET/CT at baseline and at 6 months. Forty-eight patients completed follow-up PET/CT. MDS TBR was - 6.2 ± 13.9% for patients in the ezetimibe/rosuvastatin group and - 10.8 ± 17.7% for those in the rosuvastatin group (difference, 4.6 percentage points; upper limitation of one-sided confidence interval = 13.8; p = 0.60 for noninferiority). In conclusion, combination therapy with ezetimibe 10 mg and rosuvastatin 5 mg compared with rosuvastatin 20 mg did not meet the criterion for non-inferiority for primary outcome, and the present study was not conclusive on whether the former was non-inferior to the latter. Graphical Abstract.",2020,"MDS TBR was - 6.2 ± 13.9% for patients in the ezetimibe/rosuvastatin group and - 10.8 ± 17.7% for those in the rosuvastatin group (difference, 4.6 percentage points; upper limitation of one-sided confidence interval = 13.8; p = 0.60 for noninferiority).","['Patients with Acute Coronary Syndrome', 'Fifty patients with acute coronary syndrome (ACS']","['rosuvastatin', 'ezetimibe', 'High-Dose Rosuvastatin Versus Low-Dose Rosuvastatin Plus Ezetimibe', 'ezetimibe/rosuvastatin', 'ezetimibe/rosuvastatin 10/5\xa0mg and rosuvastatin']","['carotid atherosclerotic plaque inflammation', 'MDS TBR', 'percent change in the target-to-background ratio (TBR) of the index vessel in the most diseased segment (MDS', 'Carotid Atherosclerotic Plaque Inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]",50.0,0.0339986,"MDS TBR was - 6.2 ± 13.9% for patients in the ezetimibe/rosuvastatin group and - 10.8 ± 17.7% for those in the rosuvastatin group (difference, 4.6 percentage points; upper limitation of one-sided confidence interval = 13.8; p = 0.60 for noninferiority).","[{'ForeName': 'Minyoung', 'Initials': 'M', 'LastName': 'Oh', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyunji', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eon Woo', 'Initials': 'EW', 'LastName': 'Shin', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Changhwan', 'Initials': 'C', 'LastName': 'Sung', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Do-Hoon', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dae Hyuk', 'Initials': 'DH', 'LastName': 'Moon', 'Affiliation': 'Department of Nuclear Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Seon', 'Initials': 'JS', 'LastName': 'Eo', 'Affiliation': 'Department of Nuclear Medicine, Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Cheol Whan', 'Initials': 'CW', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. cheolwlee@amc.seoul.kr.'}]",Journal of cardiovascular translational research,['10.1007/s12265-020-10009-4']
28,32363556,"The efficacy of vitamin D combined with clomiphene citrate in ovulation induction in overweight women with polycystic ovary syndrome: a double blind, randomized clinical trial.","PURPOSE
The aim of this study was to assess the effect of vitamin D supplementation on ovulation rate in overweight subfertile women with PCOS undergoing ovulation induction.
METHODS
This was a single center, parallel-groups, double-blind, and placebo-controlled randomized trial involving 186 eligible women undergoing induction of ovulation with clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily starting from the third day of menstrual cycle and for 5 days combined with either oral Vitamin D (ossofortin®, EVA PHARMA) 10,000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries) 1250 mg twice daily or to receive a placebo with calcium for three successive induction cycles. The vitamin D or placebo supplementation started 1 month before induction cycles (total four cycles). Cycles were monitored with ultrasound follicle tracking and mid-luteal serum progesterone measurement. The primary outcome was the ovulation rate after three induction cycles.
RESULTS
The study was performed during the period between January 2018 and September 2018, Eighty six (92.5%) women in the treatment group and 73 (78.5%) in the control group had successful ovulation (p = 0.007). The absolute and relative risk reduction was 14% and 65% respectively. Biochemical and clinical pregnancy occurred in 61.3 and 50.5% in the treatment group, and in 49.5 and 39.8% in the control group (p = 0.105 and 0.141 respectively).
CONCLUSION
In subfertile women with PCOS undergoing induction of ovulation, vitamin D supplementation significantly improved the ovulation rate; however, there was no effect on clinical or biochemical pregnancy.",2020,"Biochemical and clinical pregnancy occurred in 61.3 and 50.5% in the treatment group, and in 49.5 and 39.8% in the control group (p = 0.105 and 0.141 respectively).
","['overweight women with polycystic ovary syndrome', '186 eligible women undergoing induction of ovulation with', 'subfertile women with PCOS undergoing induction of', 'overweight subfertile women with PCOS undergoing ovulation induction']","['clomiphene citrate (Clomid®, Aventis) 50\u2009mg tablet twice daily starting from the third day of menstrual cycle and for 5 days combined with either oral Vitamin D (ossofortin®, EVA PHARMA', 'calcium (calciprex®, Marcyrl Pharmaceutical Industries) 1250', 'vitamin D or placebo', 'ovulation, vitamin D supplementation', 'vitamin D combined with clomiphene citrate', 'placebo with calcium', 'vitamin D supplementation', 'placebo']","['absolute and relative risk reduction', 'ovulation rate', 'Biochemical and clinical pregnancy', 'successful ovulation']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0591268', 'cui_str': 'Clomide'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0388017', 'cui_str': 'Ossofortin'}, {'cui': 'C0242686', 'cui_str': 'EVA'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0013185', 'cui_str': 'Industry, Drug'}, {'cui': 'C4517554', 'cui_str': '1250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",186.0,0.693051,"Biochemical and clinical pregnancy occurred in 61.3 and 50.5% in the treatment group, and in 49.5 and 39.8% in the control group (p = 0.105 and 0.141 respectively).
","[{'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'Rasheedy', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt. radwaebed@yahoo.com.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Sammour', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Abdellatif', 'Initials': 'A', 'LastName': 'Elkholy', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yasmine', 'Initials': 'Y', 'LastName': 'Salim', 'Affiliation': 'Port Said General Hospital, Port Said, Egypt.'}]",Endocrine,['10.1007/s12020-020-02315-3']
29,32305578,"Response to ""Effect of Aromatherapy Massage on Quality of Sleep in the Palliative Care Ward: Randomized Controlled Trial"".",,2020,,[],['Aromatherapy Massage'],['Quality of Sleep'],[],"[{'cui': 'C2585844', 'cui_str': 'Aromatherapy massage'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",,0.0879721,,"[{'ForeName': 'Masamitsu', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Faculty of Nursing, National Defense Medical College, Tokorozawa, Japan. Electronic address: masamitsu4k26@gmail.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kako', 'Affiliation': 'Division of Nursing Science, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Japanese Red Cross Kyushu International College of Nursing, Fukuoka, Japan.'}, {'ForeName': 'Yasufumi', 'Initials': 'Y', 'LastName': 'Oosono', 'Affiliation': 'Faculty of Nursing, National Defense Medical College, Tokorozawa, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Noto', 'Affiliation': 'Department of Health Sciences, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.007']
30,32363616,"The effect of synbiotic supplementation on anthropometric indices, appetite, and constipation in people with hypothyroidism: A randomized, double-blind, placebo-controlled trial.","Hypothyroidism and obesity are two highly prevalent conditions that appear to be closely related. Hypothyroidism is correlated with weight gain, loss of appetite, constipation, and a higher incidence of obesity. The present study aimed to investigate the effects of synbiotic supplementation on anthropometric indices, appetite, and constipation in subjects with hypothyroidism. Sixty subjects with hypothyroidism were assigned into two groups to receive either 500 mg/day of synbiotic (n = 30) or a placebo (n = 30) per day for 8 weeks. Anthropometric indices, appetite, and constipation were assessed at study baseline and end of the trial. At the end of trial, waist-to-hip ratio was significantly decreased in the synbiotic group (p = .030), whereas there were no significant differences between groups. We did not observe any statistically significant change in appetite or other anthropometric indices (p > .05). Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048). The results of the present trial indicated that synbiotic supplementation may have favorable results in constipation among subjects with hypothyroidism for 8 weeks. Further studies with larger sample size and longer duration are needed to confirm our findings.",2020,Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048).,"['people with hypothyroidism', 'subjects with hypothyroidism', 'subjects with hypothyroidism for 8\u2009weeks', 'Sixty subjects with hypothyroidism']","['500\u2009mg/day of synbiotic', 'synbiotic supplementation', 'placebo synbiotic supplementation', 'placebo']","['waist-to-hip ratio', 'appetite or other anthropometric indices', 'Anthropometric indices, appetite, and constipation', 'anthropometric indices, appetite, and constipation', 'weight gain, loss of appetite, constipation', 'constipation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}]",60.0,0.458891,Compared with the placebo synbiotic supplementation led to a significant reduction in constipation (p = .048).,"[{'ForeName': 'Sepide', 'Initials': 'S', 'LastName': 'Talebi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Karimifar', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Asbaghi', 'Affiliation': 'Student Research Committee, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Hadi', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Marx', 'Affiliation': 'iMPACT, School of Medicine, Deakin University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Food Security Research Center and Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6710']
31,32363638,Comparison of gabapentin and hydroxyzine in the treatment of pruritus in patients on dialysis.,"BACKGROUND
Pruritus is one of the most common problems in patients with chronic renal failure. Of all patients with end-stage renal disease (ESRD), 60-80% report pruritus during their life.
AIM
To compare the effect of gabapentin (GBP) and hydroxyzine (HYDZ) in treating pruritus in patients on dialysis.
METHODS
In a double-blind, randomized, crossover clinical trial, 32 patients on dialysis who reported pruritus were assigned randomly to receive either GBP or HYDZ for 6 weeks; the first group received GBP 100 mg/day orally and the second group received HYDZ 25 mg/day orally for 6 weeks. After this 6-week period (Period 1) there was a washout period of 2 weeks then patients were crossed over to the other drug (the first group receiving HYDZ and second group receiving GBP) and followed up for a further 6 weeks (Period 2). A visual analogue scale was used to measure pruritus intensity in the groups before and after the first and second period.
RESULTS
In Period 1, pruritus severity decreased from 7.1 ± 1.46 at baseline to 2.17 ± 1.82 at 6 weeks in the GBP group (P = 0.001) and from 6.83 ± 2.11 to 2.86 ± 1.67 in the HYDZ group (P = 0.001). In Period 2, pruritus severity decreased from 5.1 ± 1.61 at baseline to 1.56 ± 0.82 at 6 weeks in the GBP group (P < 0.01) and from 5.23 ± 2.11 to 2.1 ± 1.87 in the HYDZ group (P = 0.001).
CONCLUSION
Results showed that both HYDZ and GBP significantly improved and controlled pruritus in patients on dialysis, with no significant difference observed between the two drugs.",2020,"In the first six weeks, the severity of pruritus in Gabapentin group decreased from 7.1±1.46 at baseline to 2.17±1.82 at six weeks later (p=0.001) and in Hydroxyzine group decreased from 6.83±2.11 at baseline to 2.86±1.67 at six weeks later (p=0.001).","['patients suffering from chronic renal failure', 'dialysis patients', 'pruritus in dialysis patients', '32 dialysis patients with pruritus']","['Gabapentin capsule', 'Gabapentin or Hydroxyzine', 'Gabapentin', 'Hydroxyzine', 'Gabapentin and Hydroxyzine']","['severity of pruritus', 'controlled pruritus', 'Pruritus Scale questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0033774', 'cui_str': 'Itching'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0020404', 'cui_str': 'Hydroxyzine'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",32.0,0.135916,"In the first six weeks, the severity of pruritus in Gabapentin group decreased from 7.1±1.46 at baseline to 2.17±1.82 at six weeks later (p=0.001) and in Hydroxyzine group decreased from 6.83±2.11 at baseline to 2.86±1.67 at six weeks later (p=0.001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mohammadi Kebar', 'Affiliation': 'Departments of, Departments of, Internal Medicine, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sharghi', 'Affiliation': 'Department of, Community Medicine, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ghorghani', 'Affiliation': 'School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hoseininia', 'Affiliation': 'Departments of, Departments of, Internal Medicine, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.'}]",Clinical and experimental dermatology,['10.1111/ced.14270']
32,32362436,Effects of incentives on viral suppression in people living with HIV who use cocaine or opiates.,"BACKGROUND
Antiretroviral therapy (ART) adherence is essential to maintenance of undetectable viral loads among people living with HIV, which improves health and reduces HIV transmission. Despite these benefits, some people living with HIV do not maintain the level of adherence required to sustain an undetectable viral load. This problem is particularly common among people who use drugs.
OBJECTIVE
To determine effects of incentivizing viral suppression in people living with HIV who used cocaine or opiates.
METHODS
In this secondary analysis of data collected during a randomized controlled trial, participants (N=102) with detectable HIV viral loads (>200 copies/mL) were randomly assigned to a Usual Care or Incentive group. Usual Care participants did not earn incentives for viral suppression. Incentive participants earned incentives ($10/day maximum) for providing blood samples with reduced or undetectable (<200 copies/mL) viral loads. All participants completed assessments every three months. Results collected during the first year were compared based on group assignment and drug use.
RESULTS
Among participants who used cocaine or opiates, Incentive participants (n = 27) provided more (OR:4.0, CI:1.6-10.3, p = .004) blood samples with an undetectable viral load (69 %) than Usual Care participants (n = 25; 41 %). Among participants who did not use cocaine or opiates, Incentive participants (n = 25) provided more (OR:4.1, CI:1.5-10.7, p = .005) blood samples with an undetectable viral load (78 %) than Usual Care participants (n = 25; 36 %). Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992).
CONCLUSIONS
Incentivizing viral suppression can promote undetectable viral loads in people living with HIV who use cocaine or opiates.",2020,"Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992).
","['participants who did not use cocaine or opiates, Incentive participants (n = 25', 'people living with HIV who used cocaine or opiates', 'people who use drugs', 'people living with HIV who use cocaine or opiates', 'participants (N=102) with detectable HIV viral loads (>200 copies/mL', 'people living with HIV', 'participants who used cocaine or opiates, Incentive participants (n = 27']",['Usual Care or Incentive group'],['viral suppression'],"[{'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.168094,"Effects of incentives did not differ by drug use (OR:1.0, CI:0.3-4.0, p = .992).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pollock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: spolloc6@jhu.edu.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: ftoegel1@jhmi.edu.'}, {'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: aholtyn1@jhmi.edu.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Rodewald', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: arodewa1@jhmi.edu.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: jeannie-marie@jhu.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Department of Medicine, Comprehensive Care Practice, Johns Hopkins Bayview Medical Center, 5200 Eastern Ave # W2, Baltimore, MD 21224, USA. Electronic address: mifinger@jhmi.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for Learning and Health, Johns Hopkins University School of Medicine, 5200 Eastern Avenue Suite 350 East, Baltimore, MD, 21224, USA. Electronic address: ksilverm@jhmi.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108000']
33,32374527,A Secondary Data Analysis Examining Young Adults' Performance in an Internet Weight Loss Program with Financial Incentives.,"OBJECTIVE
In traditional behavioral weight loss (BWL) programs, young adults fare worse than older adults with respect to engagement, retention, and weight loss, but money and use of technology have been cited as program factors that might improve outcomes for this population. This study evaluated young adult performance in internet-based BWL (IBWL) offering financial incentives for self-monitoring and weight loss.
METHODS
Participants (N = 180; BMI = 33.2 ± 6.0 kg/m 2 ) were randomly assigned to a 12-week IBWL or IBWL + incentives (IBWL + $) group. This secondary data analysis compared young adults (ages 18-35) in IBWL (n = 16) with young adults in IBWL + $ (n = 12) on percent weight loss, engagement, and retention. Young adults (n = 28) were also compared with older adults (ages 36-70; n = 152) on these outcomes.
RESULTS
Young adult weight loss was -2.8% ± 5.2% in IBWL and -5.4% ± 5.7% in IBWL + $ (P = 0.23, partial η 2 = 0.06). A greater proportion of young adults in IBWL + $ achieved a 10% weight loss compared with IBWL (42% vs. 6%, P = 0.02). Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
CONCLUSIONS
Findings suggest that technology-based BWL has the potential to eliminate weight loss disparities observed between young adults and older adults in in-person BWL trials. Moreover, adding financial incentives holds promise for promoting clinically meaningful weight loss for young adults.",2020,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","['young adults', 'Participants (N\u2009=\u2009180; BMI\u2009=\u200933.2\u2009±\u20096.0 kg/m 2 ', 'young adults and older adults', 'young adults fare worse than older adults', 'Young adults (n\u2009=\u200928) were also compared with older adults (ages 36-70; n\u2009=\u2009152) on these outcomes', 'young adults (ages 18-35) in IBWL (n\u2009=\u200916) with young adults in IBWL\u2009+\u2009$ (n\u2009=\u200912) on percent weight loss, engagement, and retention']","['technology-based BWL', 'IBWL or IBWL\u2009+\u2009incentives (IBWL\u2009+\u2009$) group', 'traditional behavioral weight loss (BWL) programs']","['weight loss', 'retention or weight loss']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0386472,"Compared with older adults, young adults were less engaged, but there were no differences for retention or weight loss (P values > 0.05).
","[{'ForeName': 'Jessica Gokee', 'Initials': 'JG', 'LastName': 'LaRose', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Services, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Autumn', 'Initials': 'A', 'LastName': 'Lanoye', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reading', 'Affiliation': 'Department of Health Behavior and Policy, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, Miriam Hospital, Providence, Rhode Island, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22797']
34,32378802,Effect of bile duct clamping versus no clamping on surgical site infections in patients undergoing pancreaticoduodenectomy: a randomized controlled study.,"BACKGROUND
Infectious complications cause significant morbidity after pancreatoduodenectomy (PD). The impact of uncontrolled spillage of bile during PD has not been systematically studied.
METHODS
Patients undergoing PD for malignant lesions between March 2017 and May 2019 were considered for inclusion. All patients underwent standard pre-operative preparation and antibiotic prophylaxis. After confirmation of resectability, the patients were randomized into one of the two groups: common hepatic duct clamping using atraumatic bulldog clamp after biliary division (Group I) or no clamping (Group II). Post-operative outcomes including surgical site infection (SSI) were compared.
RESULTS
Fifty-two patients were assessed for eligibility and eventually 40 were randomized (median age: 53.5 years, 28 (70%) males). Twenty patients were randomized into each group and 14 in each group had undergone pre-operative biliary drainage. Incidence of co-morbidities, operative time and blood loss were comparable between the two groups. SSI was significantly lower in Group I (4 (20%) versus 11 (55%), P = 0.02). Number needed to treat to prevent one SSI was 3. Incidence of intra-abdominal collections was higher in Group II, though, not statistically significant (2 (10%) versus 6 (30%), P = 0.23). The duration of post-operative antibiotics was significantly higher in Group II (7 IQR 4 versus 11 IQR 7 days, P = 0.04). Among the risk factor evaluated in the entire population, higher incidence of SSI was seen in patients with positive bile culture (13 (65%) versus 2 (10%), P = 0.04).
CONCLUSION
Bile duct clamping during PD reduces risk of superficial SSI.",2020,"Incidence of intra-abdominal collections was higher in Group II, though, not statistically significant (2 (10%) versus 6 (30%), P = 0.23).","['Twenty patients', 'patients undergoing pancreaticoduodenectomy', 'pancreatoduodenectomy (PD', 'Fifty-two patients were assessed for eligibility and eventually 40 were randomized (median age: 53.5\u2009years, 28 (70%) males', 'Patients undergoing PD for malignant lesions between March 2017 and May 2019 were considered for inclusion']","['standard pre-operative preparation and antibiotic prophylaxis', 'bile duct clamping versus no clamping', 'hepatic duct clamping using atraumatic bulldog clamp after biliary division (Group I) or no clamping', 'undergone pre-operative biliary drainage']","['Incidence of co-morbidities, operative time and blood loss', 'incidence of SSI', 'SSI', 'duration of post-operative antibiotics', 'surgical site infection (SSI', 'Incidence of intra-abdominal collections', 'surgical site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0019149', 'cui_str': 'Common Hepatic Duct'}, {'cui': 'C0179935', 'cui_str': 'Bulldog clamp'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0401020', 'cui_str': 'Intra-abdominal collection'}]",20.0,0.166603,"Incidence of intra-abdominal collections was higher in Group II, though, not statistically significant (2 (10%) versus 6 (30%), P = 0.23).","[{'ForeName': 'Harjeet', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'Division of Surgical Gastroenterology, Department of General Surgery, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Krishnamurthy', 'Affiliation': 'SRM Institutes for Medical Science, Department of Surgical Gastroenterology and Transplantation, Chennai, India.'}, {'ForeName': 'Hemanth', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Department of General Surgery, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Ujjwal', 'Initials': 'U', 'LastName': 'Gorsi', 'Affiliation': 'Department of Radiodiagnosis, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar-M', 'Affiliation': 'Department of Pharmacology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Harshal', 'Initials': 'H', 'LastName': 'Mandavdhare', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Department of Gastroenterology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Thakur D', 'Initials': 'TD', 'LastName': 'Yadav', 'Affiliation': 'Division of Surgical Gastroenterology, Department of General Surgery, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}]",ANZ journal of surgery,['10.1111/ans.15947']
35,32374123,"The relation between the storage symptoms before and after transurethral resection of the prostate, analysis of the risk factors and the prevention of the symptoms with solifenacin.","OBJECTIVE AND HYPOTHESIS
We aimed to investigate the reasons of storage symptoms ( SS) after transurethral resection of the prostate (TURP). The hypothesis was that a positive correlation would be identified between preoperative and postoperative SS in patients with undergoing TURP and starting early solifenacin treatment in patients with high preoperative SS would be reasonable. In addition, we aimed to analyze multiple other risk factors for post-TURP SS.
MATERIALS AND METHODS
A total of 160 patients undergoing TURP were prospectively evaluated and divided into two groups according to their OABS. Those with a score of ≥10 points were Group 1 (G1), and those with < 10 points Group 2 (G2). In addition, patients in each group were randomly further divided into two subgroups: those who were started on 5 mg solifenacin succinate in the early postoperative period (G1/G2 A) and those who were not (G1/G2 B). In additions to SS Preop, perop and at the 3rd-month of postoperatively 14 variable were evaluated. The effects of these factors, surgery and the efficacy of an early medical treatment on the postoperative SS were investigated. LUTS were assessed by International Prostate Symptom Score (IPSS) and SS were assessed by sum of IPSS 2, 4 and 7 questionnaires (Storage, S- IPSS).
RESULTS
Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery. Only preoperative S-IPSS was found to have significant effect on postoperative SS (p< 0.001). There was a significant difference between G1A and G1B but no significant difference between G2A and G2B in terms of SS at postoperatively. In addition to this, prostatic volume was found smaller than non-symptomatic patients in de novo SS patients.
CONCLUSION
TURP provides significant improvement in both storage and voiding symptoms. The predictive value of the preoperative S-IPSS on postop SS is significant. These results suggest that 5 mg solifenacin succinate treatment in the early postoperative period may be beneficial for patients with high preoperative SS and may not be beneficial in others. Small prostatic volume may bode ill for postoperative SS in the patients with de novo SS.",2020,"RESULTS
Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery.","['patients with high preoperative SS', 'patients with de novo SS', '160 patients undergoing TURP']","['solifenacin succinate', 'TURP', 'transurethral resection of the prostate (TURP']","['prostatic volume', 'postoperative SS', 'G1A and G1B', 'storage and voiding symptoms', 'International Prostate Symptom Score (IPSS) and SS', 'Preoperative IPSS and S-IPSS', 'IPSS, S-IPSS, QoL score, Qmax, and PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C1509436', 'cui_str': 'Solifenacin succinate'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242852', 'cui_str': 'Proliferative vitreoretinopathy'}]",160.0,0.0169544,"RESULTS
Preoperative IPSS and S-IPSS were significantly higher in G1 (p< 0.001); there was a significant improvement at IPSS, S-IPSS, QoL score, Qmax, and PVR for all groups after surgery.","[{'ForeName': 'Timucin', 'Initials': 'T', 'LastName': 'Sipal', 'Affiliation': 'Depertment of Urology, Cerkezkoy State Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Akdere', 'Affiliation': 'Depertmen of Urology, Trakya University Medical Faculty, Edirne, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0227']
36,32370930,Long-term changes in delay discounting following a smoking cessation treatment for patients with depression.,"BACKGROUND
Delay discounting (DD) has been identified as a trans-disorder process underlying addictive behaviors, including smoking. Previous studies have evaluated how different treatments for drug dependence have affected DD, showing mixed results. Furthermore, no study has examined the effects of changes in depression on DD rates. The aim of this study was to evaluate the impact of treatment type: cognitive behavioral treatment (CBT), CBT + behavioral activation (BA), or CBT + BA + contingency management (CM), and changes in smoking status and depression on DD rates in long-term follow-up among a sample of treatment-seeking smokers with depression.
METHODS
Participants were 180 treatment-seeking smokers with depression who were randomly assigned to one of the following treatment conditions: CBT (n = 60), CBT + BA (n = 60), and CBT + BA + CM (n = 60). Depressive symptomatology and major depression diagnosis were evaluated through the BDI-II and the SCID-I of the DSM-IV-TR. DD rates were assessed using the DD task with hypothetical monetary rewards. Smoking status, DD, and depressive symptomatology were collected at baseline, at end-of-treatment and at one-, two-, three-, and six-month follow-ups.
RESULTS
CM for smoking cessation reduces DD rates (p = .0094). Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up.
CONCLUSIONS
CM interventions for smoking cessation, smoking abstinence, and the improvement of depression contribute to reductions in DD over time.",2020,"Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up.
","['patients with depression', 'Participants were 180 treatment-seeking smokers with depression']","['CBT', 'CBT + BA + CM', 'cognitive behavioral treatment (CBT), CBT + behavioral activation (BA), or CBT + BA + contingency management (CM', 'CBT + BA']","['Depressive symptomatology and major depression diagnosis', 'Smoking status, DD, and depressive symptomatology', 'Smoking abstinence', 'smoking status and depression on DD rates', 'DD rates', 'delay discounting', 'depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",180.0,0.0288067,"Smoking abstinence (p = .0024) and reduction in depressive symptoms (p = .0437) were associated with decreases in DD rates in long-term follow-up.
","[{'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'García-Pérez', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain. Electronic address: garciaperangel@uniovi.es.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Vallejo-Seco', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weidberg', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'González-Roz', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Secades-Villa', 'Affiliation': 'Department of Psychology. University of Oviedo, Plaza Feijoo, s/n, 33003 Oviedo, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108007']
37,32370931,Financial incentives promote engagement in employment services for unemployed adults in treatment for opioid use disorder.,"BACKGROUND
Promoting employment among unemployed adults with substance use disorder is a difficult challenge for which existing interventions have had limited effects. This study examined whether financial incentives could increase engagement in employment services for unemployed adults in treatment for opioid use disorder.
METHODS
The study was conducted from 2014 to 2019 in Baltimore, MD. After a 3-month abstinence initiation and training period, participants (N = 91) were randomly assigned to a Control group or an Incentive group and were invited to work with an employment specialist to seek employment in a community job for 12 months. Participants assigned to the Control group (n = 47) did not receive incentives for working with the employment specialist. Participants assigned to the Incentive group (n = 44) could earn financial incentives for working with the employment specialist, but had to provide opiate- and cocaine-negative urine samples to maximize pay.
RESULTS
Incentive participants attended the employment services and worked with the employment specialist on significantly more days than Control participants (41.8 % versus 1.1 % of days; OR = 40.42, 95 % CI = 32.46-48.38, p < .001), and for significantly more hours than Control participants (3.58 versus 1.25 h, on average; OR=2.34, 95 % CI=1.83-2.85, p < .001). Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001).
CONCLUSIONS
Financial incentives were effective in promoting engagement in employment services for individuals who often do not utilize employment services.",2020,"Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001).
","['2014 to 2019 in Baltimore, MD', 'unemployed adults with substance use disorder', 'unemployed adults', 'unemployed adults in treatment for opioid use disorder', 'individuals who often do not utilize employment services']","['Control group (n = 47) did not receive incentives for working with the employment specialist', 'Control group or an Incentive group and were invited to work with an employment specialist to seek employment in a community job for 12 months', 'Incentive group (n = 44) could earn financial incentives for working with the employment specialist, but had to provide opiate- and cocaine-negative urine samples to maximize pay']",['employment services and worked with the employment specialist'],"[{'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}]","[{'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",91.0,0.153669,"Incentive participants were more likely to be retained than Control participants when analyses were based solely on attendance (HR=0.12, 95 % CI=0.06-0.25, p < .001) and attendance and employment combined (HR=0.15, 95 % CI=0.07-0.31, p < .001).
","[{'ForeName': 'August F', 'Initials': 'AF', 'LastName': 'Holtyn', 'Affiliation': 'Johns Hopkins University School of Medicine, USA. Electronic address: aholtyn1@jhmi.edu.'}, {'ForeName': 'Forrest', 'Initials': 'F', 'LastName': 'Toegel', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Shrinidhi', 'Initials': 'S', 'LastName': 'Subramaniam', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Arellano', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Jeannie-Marie', 'Initials': 'JM', 'LastName': 'Leoutsakos', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fingerhood', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Silverman', 'Affiliation': 'Johns Hopkins University School of Medicine, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107982']
38,32383503,An mHealth intervention for the treatment of patients with an eating disorder: A multicenter randomized controlled trial.,"OBJECTIVE
The current multicentre randomized controlled trial assessed the clinical efficacy of a combined mHealth intervention for eating disorders (EDs) based on cognitive behavioral therapy (CBT).
METHOD
A total of 106 ED patients from eight different public and private mental health services in Spain were randomly assigned to two parallel groups. Patients of the experimental group (N = 53) received standard face-to-face CBT plus a mobile intervention through an application called ""TCApp,"" which provides self-monitoring and an online chat with the therapist. The control group (N = 53) received standard face-to-face CBT only. Patients completed self-report questionnaires on ED symptomatology, anxiety, depression, and quality of life, before and after treatment.
RESULTS
Significant reductions in primary and secondary outcomes were observed for participants of both groups, with no differences between groups. Results also suggested that the frequency with which patients attended their referral mental health institution after the intervention was lower for patients in the experimental group than for those in the control group.
DISCUSSION
The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face-to-face treatment. Besides, the additional component offered by the TCApp does not appear to be promising from a purely therapeutic perspective but perhaps as a cost-effective tool, reducing thus the costs and time burden associated with weekly visits to health professionals.",2020,"The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face-to-face treatment.","['patients with an eating disorder', '106 ED patients from eight different public and private mental health services in Spain']","['TCApp', 'CBT', 'combined mHealth intervention', 'standard face-to-face CBT only', 'mHealth intervention', 'standard face-to-face CBT plus a mobile intervention through an application called ""TCApp,"" which provides self-monitoring and an online chat with the therapist', 'cognitive behavioral therapy (CBT']","['referral mental health institution', 'self-report questionnaires on ED symptomatology, anxiety, depression, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}]","[{'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",106.0,0.0658407,"The current study showed that CBT can help to reduce symptoms relating to ED, regardless of whether its delivery includes online components in addition to traditional face-to-face treatment.","[{'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Anastasiadou', 'Affiliation': 'Department of Information and Communication Sciences, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Brugnera', 'Affiliation': 'Department of Human and Social Sciences, University of Bergamo, Bergamo, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cañas Vinader', 'Affiliation': 'Child and Adolescent Psychiatry and Psychology Department, Sant Joan de Déu Hospital of Barcelona, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'SerranoTroncoso', 'Affiliation': 'Child and Adolescent Psychiatry and Psychology Department, Sant Joan de Déu Hospital of Barcelona, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carretero Jardí', 'Affiliation': 'Eating Disorders Unit, ABB Center, Barcelona, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Linares Bertolin', 'Affiliation': 'Eating Disorders Unit, ABB Center, Barcelona, Spain.'}, {'ForeName': 'Rudiger', 'Initials': 'R', 'LastName': 'Muñoz Rodríguez', 'Affiliation': ""Child and Adolescent Psychiatry and Psychology Service, Niño Jesús University Children's Hospital, Madrid, Spain.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Martínez Nuñez', 'Affiliation': ""Child and Adolescent Psychiatry and Psychology Service, Niño Jesús University Children's Hospital, Madrid, Spain.""}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Graell Berna', 'Affiliation': ""Child and Adolescent Psychiatry and Psychology Service, Niño Jesús University Children's Hospital, Madrid, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Torralbas-Ortega', 'Affiliation': 'Child and Adolescent Mental Health Service, Parc Taulí Foundation, Research and Innovation Institute Parc Taulí (I3PT) - Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Torrent-Solà', 'Affiliation': 'Child and Adolescent Mental Health Service, Parc Taulí Foundation, Research and Innovation Institute Parc Taulí (I3PT) - Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Puntí-Vidal', 'Affiliation': 'Child and Adolescent Mental Health Service, Parc Taulí Foundation, Research and Innovation Institute Parc Taulí (I3PT) - Autonomous University of Barcelona, Sabadell, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Carrera Ferrer', 'Affiliation': 'Eating Disorders Programme IBSMIA, University Hospital Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Muñoz Domenjó', 'Affiliation': 'Department of Psychiatry, University Hospital Móstoles, Móstoles, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Diaz Marsa', 'Affiliation': 'Eating Disorders Unit, San Carlos University Hospital, Madrid, Spain.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Gunnard', 'Affiliation': 'Eating Disorders Unit, Quirón Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cusido', 'Affiliation': 'Board Member, HealthApp SL, Sabadell, Spain.'}, {'ForeName': 'Jordina', 'Initials': 'J', 'LastName': 'Arcal Cunillera', 'Affiliation': 'Board Member, HealthApp SL, Sabadell, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lupiañez-Villanueva', 'Affiliation': 'Department of Information and Communication Sciences, Universitat Oberta de Catalunya, Barcelona, Spain.'}]",The International journal of eating disorders,['10.1002/eat.23286']
39,32371987,Central catheter removal timing and growth patterns in preterm infants.,"BACKGROUND
Early discontinuation of total parenteral nutrition (TPN) at 100 ml/kg/day of enteral feeds, compared with 140 ml/kg/day, led to significant delay in time to regain the birth weight in very low birth weight infants (birth weight < 1500 g, VLBW). Our aim was to compare the growth of infants in relation with timing of TPN discontinuation up to 2 years corrected gestational age (CGA).
METHODS
Posttrial follow-up study using review of paper medical records. Participants of the randomized controlled trial studying effect of early parenteral nutrition discontinuation on time to regain birth weight in VLBW infants were included. Growth parameters inclusive of weight, length, and occipital-frontal circumference (OFC) were collected. Z-scores were calculated at five predefined time points-birth, 0-11 weeks CGA, 12-35 weeks CGA, 36-60 weeks CGA, and 61-96 weeks CGA and compared for control and intervention groups.
RESULTS
Regarding weight, we found lower mean Z-score in the intervention group between 0 and 11 weeks CGA, with larger difference in extremely low birth weight infants (birth weight < 1000 g, ELBW), but this did not reach the statistical significance. Regarding length, the same difference, slightly delayed to 35 weeks CGA was observed and reached statistical significance for ELBW infants between 12 and 35 weeks CGA. There was no difference in OFC mean Z-scores at any timepoint.
CONCLUSIONS
The discontinuation of TPN at 100 ml/kg/day showed significantly lower Z-score for length in ELBW infants between 12 and 35 weeks CGA. There were no differences in Z-scores by 2 years CGA.",2020,The discontinuation of TPN at 100 ml/kg/day showed significantly lower Z-score for length in ELBW infants between 12 and 35 weeks CGA.,"['VLBW infants', 'infants in relation with timing of TPN discontinuation up to 2 years corrected gestational age (CGA', 'preterm infants']","['parenteral nutrition discontinuation', 'total parenteral nutrition (TPN']","['weight, length, and occipital-frontal circumference (OFC', 'mean Z-score', 'time to regain birth weight', 'CGA', 'OFC mean Z-scores', 'discontinuation of TPN', 'Z-scores']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0030548', 'cui_str': 'Total parenteral nutrition'}]",,0.0622583,The discontinuation of TPN at 100 ml/kg/day showed significantly lower Z-score for length in ELBW infants between 12 and 35 weeks CGA.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Branagan', 'Affiliation': 'Coombe Women and Infants, University Hospital, Dublin, Ireland. branagaa@tcd.ie.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Perrem', 'Affiliation': 'Coombe Women and Infants, University Hospital, Dublin, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Semberova', 'Affiliation': 'Coombe Women and Infants, University Hospital, Dublin, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': ""O'Sullivan"", 'Affiliation': 'Coombe Women and Infants, University Hospital, Dublin, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Miletin', 'Affiliation': 'Coombe Women and Infants, University Hospital, Dublin, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Doolan', 'Affiliation': 'Coombe Women and Infants, University Hospital, Dublin, Ireland.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0645-0']
40,32372046,The Influence of Listening to Music on Adults with Left-behind Experience Revealed by EEG-based Connectivity.,"The human brain has a close relationship with music. Music-induced structural and functional brain changes have been demonstrated in the healthy adult. In the present study, adults with left-behind experience (ALB) were divided into two groups. The experimental group (ALB-E) took part in the music therapy experiment with three stages, including before listening to music (pre-stage), initially listening to music (mid-stage) and after listening to music (post-stage). The control group (ALB-C) did not participate in music therapy. Scalp resting-state EEGs of ALB were recorded during the three stages. We found no significant frequency change in the ALB-C group. In the ALB-E group, only the theta power spectrum was significantly different at all stages. The topographical distributions of the theta power spectrum represented change in trends from the frontal regions to the occipital regions. The result of Granger causal analysis (GCA), based on theta frequency, showed a stronger information flow from the middle frontal gyrus to the middle temporal gyrus (MFG → MTG) in the left hemisphere at the pre-stage compared to the post-stage. Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group. Our results demonstrate that listening to music can play a positive role on improving negative feelings for individuals with left behind experience.",2020,"Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group.","['Adults with Left-behind Experience Revealed by EEG-based Connectivity', 'adults with left-behind experience (ALB', 'healthy adult']",['Listening to Music'],"['Scalp resting-state EEGs of ALB', 'negative feelings', 'weaker information flow from inferior gyrus to superior temporal gyrus (IFG\u2009→\u2009STG']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0152309', 'cui_str': 'Structure of superior temporal gyrus'}]",,0.025094,"Additionally, the experimental group showed a weaker information flow from inferior gyrus to superior temporal gyrus (IFG → STG) in the right hemisphere at post-test stage compared to the ALB-C group.","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China. tiany20032003@163.com.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Bio-information College, ChongQing University of Posts and Telecommunications, ChongQing, 400065, China.'}, {'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Sichuan Heguang Clinical Psychology Institute, ChengDu, 610074, China.'}]",Scientific reports,['10.1038/s41598-020-64381-x']
41,32375676,Pacemaker detected active minutes are superior to pedometer-based step counts in measuring the response to physical activity counseling in sedentary older adults.,"BACKGROUND
In patients with permanent pacemakers (PPM), physical activity (PA) can be monitored using embedded accelerometers to measure pacemaker detected active hours (PDAH), a strong predictor of mortality. We examined the impact of a PA Counseling (PAC) intervention on increasing activity as measured by PDAH and daily step counts.
METHODS
Thirteen patients (average age 80 ± 6 years, 84.6% women) with implanted Medtronic PPMs with a ≤ 2 PDAH daily average were included in this study. Patients were randomized to Usual Care (UC, N = 6) or a Physical Activity Counseling Intervention (PACI, N = 7) groups. Step count and PDAH data were obtained at baseline, following a 12-week intervention, then 12 weeks after intervention completion. Data were analyzed using independent t-tests, Pearson's r, chi-square, and general linear models for repeated measures.
RESULTS
PDAH significantly differed by time point for all subject combined (P = 0.01) but not by study group. Subjects with baseline gait speeds of > 0.8 m/sec were responsible for the increases in PDAH observed. Step counts did not differ over time in the entire cohort or by study group. Step count and PDAH significantly correlated at baseline (r = 0.60, P = 0.03). This correlation disappeared by week 12.
CONCLUSION(S)
PDAH can be used to monitor PA and PA interventions and may be superior to hip-worn pedometers in detecting activity. A significant increase in PA, regardless of treatment group, suggests that patient awareness of the ability to monitor PA through a PPM increases PA in these patients, particularly in patients with gait speeds of < 0.8 m/sec.
TRIAL REGISTRATION
ClincalTrials.gov NCT03052829. Date of Registration: 2/14/2017.",2020,"RESULTS
PDAH significantly differed by time point for all subject combined (P = 0.01) but not by study group.","['Thirteen patients (average age 80\u2009±\u20096\u2009years, 84.6% women) with implanted Medtronic PPMs with a\u2009≤\u20092 PDAH daily average were included in this study', 'sedentary older adults', 'patients with permanent pacemakers (PPM), physical activity (PA']","['Usual Care (UC, N\xa0=\u20096) or a Physical Activity Counseling Intervention (PACI, N\xa0=\u20097) groups', 'physical activity counseling', 'PA Counseling (PAC) intervention']","['Step count and PDAH data', 'Step count and PDAH', 'PA']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0294036,"RESULTS
PDAH significantly differed by time point for all subject combined (P = 0.01) but not by study group.","[{'ForeName': 'Venkata K', 'Initials': 'VK', 'LastName': 'Puppala', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Hofeld', 'Affiliation': 'Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Amberly', 'Initials': 'A', 'LastName': 'Anger', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Sudhi', 'Initials': 'S', 'LastName': 'Tyagi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Strath', 'Affiliation': 'College of Health Sciences Department of Kinesiology, University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Marcie G', 'Initials': 'MG', 'LastName': 'Berger', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Kwang Woo', 'Initials': 'KW', 'LastName': 'Ahn', 'Affiliation': 'Department of Biostatistics, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Widlansky', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Medical College of Wisconsin, Milwaukee, WI, USA. mwidlans@mcw.edu.'}]",BMC geriatrics,['10.1186/s12877-020-01559-y']
42,32376984,"Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial Exercise, endothelium and blood pressure.","Endothelial dysfunction is a characteristic of systemic arterial hypertension (SAH) and an early marker of atherosclerosis. Aerobic exercise training (AT) improves endothelial function. However, the effects of resistance training (RT) and combined training (CT) on endothelial function remain controversial in individuals with SAH. We determined the effects of AT, RT, and CT on endothelial function and systolic (SBP)/diastolic blood pressure (DBP) in individuals with prehypertension or hypertension. Forty-two participants (54 ± 11 y, resting SBP/DBP 137 ± 9/86 ± 6 mmHg) were randomly allocated into AT (n = 14, 40 min of cycling, 50-75% heart rate reserve), RT (n = 14, 6 resistance exercises, 4 × 12 repetitions, 60% maximum strength) and CT (n = 14, 2 × 12 repetitions of RT + 20 min of AT). All participants performed a 40-minute exercise session twice a week for 8 weeks. Endothelial function was evaluated by brachial artery flow-mediated dilation (FMD). Blood pressure was evaluated through ambulatory monitoring for 24 hours. After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT. All 3 exercise training modalities produced similar improvements in FMD: + 3.2% (95%CI 1.7, 4.6) (p < 0.001) in AT; + 4.0% (95%CI 2.1, 5.7) (p < 0.001) in RT; and +6.8% (95%CI 2.6, 11.1) (p = 0.006) in CT. In conclusion, different exercise training modalities were similarly effective in improving endothelial function but impacts on ambulatory blood pressure appear to be variable in individuals with prehypertension or hypertension.",2020,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","['Forty-two participants (54\u2009±\u200911\u2009y, resting SBP/DBP 137\u2009±\u20099/86\u2009±\u20096\u2009mmHg', 'individuals with SAH', 'individuals with prehypertension or hypertension']","['AT, RT, and CT', '40-minute exercise session', 'exercise training modalities', 'Aerobic exercise training (AT', 'resistance training (RT) and combined training (CT']","['endothelial function', 'Endothelial function', 'blood pressure', 'endothelial function and systolic (SBP)/diastolic blood pressure (DBP', 'ambulatory blood pressure', 'brachial artery flow-mediated dilation (FMD', 'FMD', 'Blood pressure', 'endothelial function improvements']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.0337369,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-64365-x']
43,32318872,"Cross-sectoral video consultations in cancer care: perspectives of cancer patients, oncologists and general practitioners.","PURPOSE
Multidisciplinary video consultations are one method of improving coherence and coordination of care in cancer patients, but knowledge of user perspectives is lacking. Continuity of care is expected to have a significant impact on the quality of cancer care. Enhanced task clarification and shared responsibility between the patient, oncologist and general practitioner through video consultations might provide enhanced continuity in cancer care.
METHOD
We used descriptive survey data from patients and doctors in the intervention group based on a randomised controlled trial to evaluate the user perspectives and fidelity of the intervention.
RESULTS
Patients expressed that they were able to present their concerns in 95% of the consultations, and believed it was beneficial to have both their doctors present in 84%. The general practitioner and oncologist found that tripartite video consultation would lead to better coordination of care in almost 90% of the consultations. However, the benefits of handling social issues and comorbidity were sparser. Consultations were not accomplished in 11% due to technical problems and sound and video quality were non-satisfactory in 20%.
CONCLUSION
Overall, multidisciplinary video consultations between cancer patient, general practitioner and oncologist were feasible in daily clinics. Initial barriers to address were technical issues and seamless planning. Patients reported high satisfaction, patient centredness and clarity of roles. General practitioners and oncologists were overall positive regarding role clarification and continuity, although less pronounced than patients.
TRIAL REGISTRATION
www.clincialtrials.gov , NCT02716168.",2021,"Consultations were not accomplished in 11% due to technical problems and sound and video quality were non-satisfactory in 20%.
","['cancer patients, oncologists and general practitioners', 'cancer patients']",[],['technical problems and sound and video quality'],"[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]",[],"[{'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.060148,"Consultations were not accomplished in 11% due to technical problems and sound and video quality were non-satisfactory in 20%.
","[{'ForeName': 'Theis Bitz', 'Initials': 'TB', 'LastName': 'Trabjerg', 'Affiliation': 'Research Unit of General Practice, Department of Public Health, University of Southern Denmark, J.B. Winsloews Vej 9A, 5000, Odense C, Denmark. ttrabjerg@health.sdu.dk.'}, {'ForeName': 'Lars Henrik', 'Initials': 'LH', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, Lillebaelt University Hospital, Vejle, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Søndergaard', 'Affiliation': 'Research Unit of General Practice, Department of Public Health, University of Southern Denmark, J.B. Winsloews Vej 9A, 5000, Odense C, Denmark.'}, {'ForeName': 'Jeffrey James', 'Initials': 'JJ', 'LastName': 'Sisler', 'Affiliation': 'Department of Family Medicine, Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dorte Gilså', 'Initials': 'DG', 'LastName': 'Hansen', 'Affiliation': 'Research Unit of General Practice, Department of Public Health, University of Southern Denmark, J.B. Winsloews Vej 9A, 5000, Odense C, Denmark.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05467-0']
44,31806129,Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction.,"BACKGROUND
The PARAGON-HF (Prospective Comparison of ARNI With ARB Global Outcomes in HF With Preserved Ejection Fraction) trial tested the efficacy of sacubitril-valsartan in patients with heart failure with preserved ejection fraction (HFpEF). Existing data on cardiac structure and function in patients with HFpEF suggest significant heterogeneity.
OBJECTIVES
The aim of this study was to characterize cardiac structure and function, quantify their associations with clinical outcomes, and contextualize these findings with other HFpEF studies.
METHODS
Echocardiography was performed in 1,097 of 4,822 PARAGON-HF patients within 6 months of enrollment. Associations with incident first heart failure hospitalization or cardiovascular death were assessed using Cox proportional hazards models adjusted for age, sex, region of enrollment, randomized treatment, N-terminal pro-brain natriuretic peptide, and clinical risk factors.
RESULTS
Average age was 74 ± 8 years, 53% of patients were women, median N-terminal pro-brain natriuretic peptide level was 918 pg/ml (interquartile range: 485 to 1,578 pg/ml), 94% had hypertension, and 35% had atrial fibrillation. The mean left ventricular (LV) ejection fraction was 58.6 ± 9.8%, prevalence of LV hypertrophy was 21%, prevalence of left atrial enlargement was 83%, prevalence of elevated E/e' ratio was 53%, and prevalence of pulmonary hypertension was 31%. Heart failure hospitalization or cardiovascular death occurred in 288 patients at 2.8-year median follow-up. In fully adjusted models, higher LV mass index (hazard ratio [HR]: 1.05 per 10 g/m 2 ; 95% confidence interval [CI]: 1.00 to 1.10; p = 0.03), E/e' ratio (HR: 1.04 per unit; 95% CI: 1.02 to 1.06; p < 0.001), pulmonary artery systolic pressure (HR: 1.51 per 10 mm Hg; 95% CI: 1.29 to 1.76; p < 0.001), and right ventricular end-diastolic area (HR: 1.04 per cm 2 ; 95% CI: 1.01 to 1.07; p = 0.003) were each associated with this composite, while LV ejection fraction and left atrial size were not (p > 0.05 for all). Appreciable differences were observed in cardiac structure compared with other HFpEF clinical trials, despite similar E/e' ratio, pulmonary artery systolic pressure, and event rates.
CONCLUSIONS
Diastolic dysfunction, left atrial enlargement, and pulmonary hypertension were common in PARAGON-HF. LV hypertrophy, elevated left- and right-sided pressures, and right ventricular enlargement were independently predictive of incident heart failure hospitalization or cardiovascular death. Echocardiographic differences among HFpEF trials despite similar clinical event rates highlight the heterogeneity of this syndrome. (Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction [PARAGON-HF]; NCT01920711).",2019,"Appreciable differences were observed in cardiac structure compared with other HFpEF clinical trials, despite similar E/e' ratio, pulmonary artery systolic pressure, and event rates.
","['patients with HFpEF', '288 patients at 2.8-year median follow-up', 'Echocardiography was performed in 1,097 of 4,822 PARAGON-HF patients within 6\xa0months of enrollment', 'patients with heart failure with preserved ejection fraction (HFpEF', 'Patients\xa0With Heart\xa0Failure and Preserved', 'Average age was 74 ± 8 years, 53% of patients were women, median N-terminal pro-brain natriuretic peptide level was 918 pg/ml (interquartile range: 485 to 1,578 pg/ml), 94% had hypertension, and 35% had atrial fibrillation', 'Heart\xa0Failure Patients With Preserved Ejection Fraction [PARAGON-HF']","['LCZ696', 'sacubitril-valsartan', 'Valsartan', 'HF']","['pulmonary hypertension', 'pulmonary artery systolic pressure', 'Heart failure hospitalization or cardiovascular death', 'cardiac structure', 'cardiovascular death', 'Diastolic dysfunction, left atrial enlargement, and pulmonary hypertension', 'prevalence of left atrial enlargement', 'prevalence of LV hypertrophy', 'LV hypertrophy, elevated left- and right-sided pressures, and right ventricular enlargement', 'right ventricular end-diastolic area', 'Morbidity and Mortality', 'mean left ventricular (LV) ejection fraction', ""E/e' ratio, pulmonary artery systolic pressure, and event rates"", 'LV ejection fraction and left atrial size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0616412', 'cui_str': 'paragon'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1533071', 'cui_str': 'N terminal pro-brain natriuretic peptide level'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0232309', 'cui_str': 'Left atrial hypertrophy by EKG'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162770', 'cui_str': 'Right ventricular hypertrophy'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.252585,"Appreciable differences were observed in cardiac structure compared with other HFpEF clinical trials, despite similar E/e' ratio, pulmonary artery systolic pressure, and event rates.
","[{'ForeName': 'Amil M', 'Initials': 'AM', 'LastName': 'Shah', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ashah11@rics.bwh.harvard.edu.""}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Cikes', 'Affiliation': 'University of Zagreb School of Medicine and University Hospital Centre Zagreb, Department for Cardiovascular Diseases, Zagreb, Croatia.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Guichu', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Stoyan', 'Initials': 'S', 'LastName': 'Getchevski', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Rizkala', 'Affiliation': 'Novartis, East Hanover, New Jersey.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Lukashevich', 'Affiliation': 'Novartis, East Hanover, New Jersey.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Ziekenhuis Oost Limburg, Genk, Belgium.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'The Medical University of South Carolina and the Ralph H. Johnson VA Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'National Heart Centre Singapore and Duke-National University of Singapore, Singapore; University Medical Centre Groningen, Groningen, the Netherlands; The George Institute for Global Health, Newtown, New South Wales, Australia.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.063']
45,32382859,"Comparison of the Long-Term Results of Puncture, Aspiration, Injection and Re-aspiration (PAIR) and Catheterization Techniques for the Percutaneous Treatment of CE1 and CE3a Liver Hydatid Cysts: A Prospective Randomized Trial.","PURPOSE
To evaluate and compare the results of puncture, aspiration, injection and re-aspiration (PAIR) and catheterization techniques for treatment of CE1 and CE3a liver hydatid cysts according to World Health Organization classification.
MATERIALS AND METHODS
Forty patients (29 females) with 56 liver CE1and CE3a cysts were prospectively randomized and enrolled into 2 groups by sealed envelope method. Procedures were performed under general anesthesia. Several parameters including technical success (completing procedure steps), clinical success (lack of recurrence on follow-up), major and minor complications, long-term changes of cyst cavities and length of hospital stay were compared between two groups.
RESULTS
As in 2 patients with 3 cysts, PAIR technique had to be changed to catheterization technique due to technical reasons. The technical success rates were 91.9% and 100% for PAIR and catheterization groups, respectively. Volume decrease rates were 78.5% and 86.8% in PAIR and catheterization groups, with a mean follow-up of 78.1 and 71 months, respectively. There was no mortality, anaphylactic shock or intraabdominal dissemination. The rate of major complications such as abscess, cysto-biliary fistula and recurrence was 2.94% and 36.84% in PAIR and catheterization groups, respectively (p = 0.002). Median length of hospital stay was shorter in PAIR group (1 vs 4 days) (p = 0.015).
CONCLUSION
PAIR technique should be preferred to catheterization technique for treatment of liver CE1 and CE3a cysts due to lower rates of major complications and length of hospital stay. Catheterization technique should be employed when cysto-biliary fistula was evident.",2020,"Median length of hospital stay was shorter in PAIR group (1 vs 4 days) (p = 0.015).
","['CE1 and CE3a Liver Hydatid Cysts', 'Forty patients (29 females) with 56 liver CE1and CE3a cysts']","['puncture, aspiration, injection and re-aspiration (PAIR) and catheterization techniques', 'Puncture, Aspiration, Injection and Re-aspiration (PAIR) and Catheterization Techniques']","['rate of major complications such as abscess, cysto-biliary fistula and recurrence', 'mortality, anaphylactic shock or intraabdominal dissemination', 'Median length of hospital stay', 'Volume decrease rates', 'clinical success (lack of recurrence on follow-up), major and minor complications, long-term changes of cyst cavities and length of hospital stay', 'technical success', 'technical success rates']","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0013502', 'cui_str': 'Echinococcosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]","[{'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0005417', 'cui_str': 'Fistula of bile duct'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C0230168', 'cui_str': 'Abdominopelvic cavity structure'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0449851', 'cui_str': 'Technique'}]",2.0,0.0334107,"Median length of hospital stay was shorter in PAIR group (1 vs 4 days) (p = 0.015).
","[{'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Akhan', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey. akhano@tr.net.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Erdoğan', 'Affiliation': 'Department of Radiology, Eskisehir Yunus Emre State Hospital, 26190, Eskişehir, Turkey.'}, {'ForeName': 'Turkmen Turan', 'Initials': 'TT', 'LastName': 'Ciftci', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Unal', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey.'}, {'ForeName': 'Ergun', 'Initials': 'E', 'LastName': 'Karaağaoğlu', 'Affiliation': 'Department of Biostatistics, Hacettepe University, 06100, Ankara, Turkey.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Akinci', 'Affiliation': 'Department of Radiology, Hacettepe University School of Medicine, 06100, Ankara, Turkey.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02477-7']
46,32383634,Effects of Kinesiotape vs Soft and Semirigid Ankle Orthoses on Balance in Patients With Chronic Ankle Instability: A Randomized Controlled Trial.,"BACKGROUND
Chronic ankle instability (CAI) is a frequent complication of ankle sprain that may be associated with long-term consequences. Although taping and bracing are common interventions that are widely used by clinicians and athletic trainers for patients with CAI, no studies have compared the effects of kinesiotaping and bracing on balance performance in these patients. The present study aimed to compare the effects of ankle kinesiotaping, a soft ankle orthosis, and a semirigid ankle orthosis on balance performance in patients with CAI.
METHODS
Sixty patients with CAI were randomly assigned to 4 groups that received kinesiotaping, a soft orthosis, a semirigid orthosis, or no treatment (control group). Dynamic and static balance were measured with the modified Star Excursion Balance Test, single leg hop test, and single leg stance test before and after a 4-week intervention period.
RESULTS
Significant between-group differences were seen in all evaluated outcomes ( P ≤ .003). The lowest reach distances in all directions in the modified Star Excursion Balance Test were found in the control group, and these patients also had a significantly shorter measured distance in the single leg hop test, and more errors in the single leg stance test compared with the 3 intervention groups. No significant differences were found among the 3 intervention groups.
CONCLUSION
Use of kinesiotaping and a soft or a semirigid ankle brace for 4 weeks were all beneficial in improving static and dynamic balance in individuals with CAI. None of the interventions was superior to the other 2.
LEVEL OF EVIDENCE
Level I, randomized controlled trial.",2020,"The lowest reach distances in all directions in the modified Star Excursion Balance Test were found in the control group, and these patients also had a significantly shorter measured distance in the single leg hop test, and more errors in the single leg stance test compared with the 3 intervention groups.","['individuals with CAI', 'patients with CAI', 'Patients With Chronic Ankle Instability', 'Sixty patients with CAI']","['kinesiotaping, a soft orthosis, a semirigid orthosis, or no treatment (control group', 'Kinesiotape vs Soft and Semirigid Ankle Orthoses']","['Dynamic and static balance', 'balance performance', 'static and dynamic balance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",60.0,0.0598824,"The lowest reach distances in all directions in the modified Star Excursion Balance Test were found in the control group, and these patients also had a significantly shorter measured distance in the single leg hop test, and more errors in the single leg stance test compared with the 3 intervention groups.","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hadadi', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Fars, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Haghighat', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mohammadpour', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sobhan', 'Initials': 'S', 'LastName': 'Sobhani', 'Affiliation': 'Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Foot & ankle international,['10.1177/1071100720917181']
47,32379496,Type 1 Doing Well: Pilot Feasibility and Acceptability Study of a Strengths-Based mHealth App for Parents of Adolescents with Type 1 Diabetes.,"Background: We evaluated the feasibility and acceptability of a pilot behavioral intervention delivered to parents of adolescents with type 1 diabetes (T1D) via mobile-friendly web app. The Type 1 Doing Well app aimed to promote supportive family diabetes management by helping parents recognize and reinforce teens' positive diabetes-related behaviors (""strengths""). Methods: Parents ( n = 80, 74% recruitment) of adolescents (age range = 12-17 years, M = 15.3 ± 1.5 years, 59% female, 56% insulin pump, M hemoglobin A1c (HbA1c) = 9.0% ± 2.1%) were randomized 2:1 to intervention or control (i.e., usual medical care with or without app) for 3-4 months between diabetes appointments. The app prompted parents daily to track adolescents' strengths and generated weekly summaries of their teen's top strengths. Parents could access a library of text messages to praise their teens. Exploratory pre/post data included questionnaires (98% completed) and HbA1c. Results: Parents used the app for M = 106.1 ± 37.1 days, logging in ≥once/day on 80% of days. Ninety-one percent of parents used the app ≥2 days/week on average. Parents viewed M = 5.6 ± 4.7 weekly summaries and ""favorited"" 15 praise texts in the library. App acceptability ratings (7-point scale) were high: Satisfaction 5.0 ± 1.5, Usefulness 4.8 ± 1.5, Ease of Use 6.2 ± 0.8, and Ease of Learning 6.5 ± 0.8. Parents ( n = 48) and adolescents ( n = 47) gave positive feedback and suggestions via qualitative interviews. There were no significant between-group differences for change in exploratory outcomes (HbA1c, questionnaires). Conclusions: Type 1 Doing Well was feasible to deliver and highly acceptable and engaging for parents of adolescents with T1D. It may have a larger impact on behavioral or clinical outcomes as part of a multicomponent intervention protocol. Trial Registration: ClinicalTrials.gov NCT02877680.",2020,"There were no significant between-group differences for change in exploratory outcomes (HbA1c, questionnaires).
","['Parents of Adolescents with Type 1 Diabetes', 'parents of adolescents with type 1 diabetes (T1D) via mobile-friendly web app', 'Parents (n=80, 74% recruitment) of adolescents (age range=12-17 years, M=15.3±1.5 years, 59% female, 56% insulin pump, M HbA1c=9.0±2.1', 'parents of adolescents with T1D', 'Parents (n=48) and adolescents (n=47) gave positive feedback and suggestions via qualitative interviews']","['pilot behavioral intervention', 'Strengths-Based mHealth App', 'intervention or control (i.e., usual medical care with or without app']","['App acceptability ratings (7-point scale', 'exploratory outcomes (HbA1c, questionnaires']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0547326,"There were no significant between-group differences for change in exploratory outcomes (HbA1c, questionnaires).
","[{'ForeName': 'Marisa E', 'Initials': 'ME', 'LastName': 'Hilliard', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Viena T', 'Initials': 'VT', 'LastName': 'Cao', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Sahar S', 'Initials': 'SS', 'LastName': 'Eshtehardi', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Dan L. Duncan Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Saber', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Lefkothea P', 'Initials': 'LP', 'LastName': 'Karaviti', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, Texas, USA.""}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0048']
48,32371747,Evacuation of Vulnerable and Critical Patients: Multimodal Simulation for Nurse-Led Patient Evacuation.,"INTRODUCTION
Virtual simulation (VS) is an adaptable medium for teaching critical disaster management skills such as efficient hospital evacuation. We aimed to compare VS and prerecorded narrated multimedia lecture-based training of pediatric nurses for evacuation of a sick newborn in the neonatal intensive care unit and pediatric emergency department (ED) using live evacuation simulations.
METHODS
Thirty neonatal intensive care unit and 30 ED nurses enrolled with 30 randomized to multimedia lecture and 30 randomized to VS, with equal block distribution of nurses from each unit. Pretraining/posttraining surveys were administered, and live evacuation simulations were scored for time to evacuation, items collected, and communication.
RESULTS
Overall, disaster preparation and communication improved within the VS group as compared with the multimedia lecture group. Virtual simulation rated more immersive (P < 0.001), better at safety threat identification (P < 0.05), and better at evacuation preparation compared with multimedia lecture (P < 0.01). Virtual simulation participants felt more prepared in disaster response (P < 0.001) and patient evacuation (P < 0.001). Both groups packed equal essential items, but VS participants packed more equipment (mean, 19 vs. 15, P < 0.01) with no significant evacuation time difference between the VS group (145 ± 58 seconds) and multimedia lecture group (152 ± 59 seconds, P = not significant). Virtual simulation participants had better communication ratings with the charge nurse (P < 0.05) and family (P < 0.001).
CONCLUSIONS
Virtual simulation was well received by nurses compared with multimedia lecture and may be an effective adjunct for training nurses on infant patient evacuation during a disaster.",2020,Virtual simulation participants felt more prepared in disaster response (P < 0.001) and patient evacuation (P < 0.001).,"['Thirty neonatal intensive care unit and 30 ED nurses enrolled with 30 randomized to multimedia lecture and 30 randomized to VS, with equal block distribution of nurses from each unit', 'pediatric nurses for evacuation of a sick newborn in the neonatal intensive care unit and pediatric emergency department (ED']","['VS and prerecorded narrated multimedia lecture-based training', 'Virtual simulation (VS']","['evacuation time difference', 'communication ratings', 'Overall, disaster preparation and communication', 'disaster response', 'patient evacuation']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030753', 'cui_str': 'Nursing, Pediatric'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012618', 'cui_str': 'Disasters'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.118936,Virtual simulation participants felt more prepared in disaster response (P < 0.001) and patient evacuation (P < 0.001).,"[{'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Gray', 'Affiliation': ""From the Division of Neonatology (M.M.G., R.A.U.), Department of Pediatrics; Division of Pediatric Emergency Medicine (A.A.T.), Department of Pediatrics, University of Washington and Seattle Children's Hospital; and Division of Pediatric Emergency Medicine (B.B.), Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Anita Anne', 'Initials': 'AA', 'LastName': 'Thomas', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Burns', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Umoren', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000451']
49,32386466,Group-based multimodal physical therapy in women with chronic pelvic pain: A randomized controlled trial.,"INTRODUCTION
Chronic pelvic pain in women is a complex condition, and physical therapy is recommended as part of a broader treatment approach. The objective of this study was to compare structured group-based multimodal physical therapy in a hospital setting (intervention group) with primary-care physical therapy (comparator group) for women with chronic pelvic pain.
MATERIAL AND METHODS
Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible. The primary outcome measure was change in the mean pelvic pain intensity from baseline to 12 months, measured using the numeric rating scale (0-10). Secondary outcomes were changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation. The differences between the groups regarding change in scores were analyzed using the independent t test and Mann-Whitney U test. Sensitivity analysis of the primary outcome was performed with a linear regression model adjusted for the baseline value. A P value <.05 was considered statistically significant.
RESULTS
Of the 62 women included, 26 in the intervention group and 25 in the comparator group were available after 12 months for data collection and analysis. The difference between the groups for change in the mean pain intensity score was -1.2 (95% CI -2.3 to -0.2; P = .027), favoring the intervention group. The intervention group showed greater improvements in respiratory patterns (mean difference 0.9; 95% CI 0.2-1.6; P = .015) and pain-related fear of movements (mean difference 2.9; 95% CI -5.5 to -0.3; P = .032), and no significant differences were observed between the groups for the other secondary outcomes.
CONCLUSIONS
Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary-care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.",2020,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","['women with chronic pelvic pain', 'Women aged 20-65 years with pelvic pain ≥6 months and referred for physical therapy were eligible']","['multimodal physical therapy', 'primary care physical therapy (comparator group', 'structured group-based multimodal physical therapy']","['mean pain intensity score', 'respiratory patterns', 'pain-related fear of movements', 'numeric rating scale', 'changes in scores of ""worst"" and ""least"" pain intensity, health-related quality of life, movement patterns, pain-related fear of movements, anxiety and depression, subjective health complaints, sexual function, incontinence, and obstructed defecation', 'mean pelvic pain intensity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0549186', 'cui_str': 'Obstructed'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.107811,"Although the reduction in the mean pelvic pain intensity with group-based multimodal physical therapy was significantly more than with primary care physical therapy, the difference in the change between the groups was less than expected and the clinical relevance is uncertain.","[{'ForeName': 'Ane Sigrid', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona Birgitte', 'Initials': 'MB', 'LastName': 'Rydningen', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Slawomir', 'Initials': 'S', 'LastName': 'Wojniusz', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Marthe', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Clinical Research Department, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Rolv-Ole', 'Initials': 'RO', 'LastName': 'Lindsetmo', 'Affiliation': 'Department of Gastroenterological Surgery, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro Killi', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13896']
50,32385598,Effect of real-time virtual reality-based teaching cues on learning needle passing for robot-assisted minimally invasive surgery: a randomized controlled trial.,"PURPOSE
Current virtual reality-based (VR) simulators for robot-assisted minimally invasive surgery (RAMIS) training lack effective teaching and coaching. Our objective was to develop an automated teaching framework for VR training in RAMIS. Second, we wanted to study the effect of such real-time teaching cues on surgical technical skill acquisition. Third, we wanted to assess skill in terms of surgical technique in addition to traditional time and motion efficiency metrics.
METHODS
We implemented six teaching cues within a needle passing task on the da Vinci Skills Simulator platform (noncommercial research version). These teaching cues are graphical overlays designed to demonstrate ideal surgical technique, e.g., what path to follow while passing needle through tissue. We created three coaching modes: TEACH (continuous demonstration), METRICS (demonstration triggered by performance metrics), and USER (demonstration upon user request). We conducted a randomized controlled trial where the experimental group practiced using automated teaching and the control group practiced in a self-learning manner without automated teaching.
RESULTS
We analyzed data from 30 participants (14 in experimental and 16 in control group). After three practice repetitions, control group showed higher improvement in time and motion efficiency, while experimental group showed higher improvement in surgical technique compared to their baseline measurements. The experimental group showed more improvement than the control group on a surgical technique metric (at what angle is needle grasped by an instrument), and the difference between groups was statistically significant.
CONCLUSION
In a pilot randomized controlled trial, we observed that automated teaching cues can improve the performance of surgical technique in a VR simulator for RAMIS needle passing. Our study was limited by its recruitment of nonsurgeons and evaluation of a single configuration of coaching modes.",2020,"The experimental group showed more improvement than the control group on a surgical technique metric (at what angle is needle grasped by an instrument), and the difference between groups was statistically significant.
","['30 participants (14 in experimental and 16 in control group', 'robot-assisted minimally invasive surgery']","['automated teaching cues', 'automated teaching and the control group practiced in a self-learning manner without automated teaching', 'real-time virtual reality-based teaching cues', 'virtual reality-based (VR) simulators for robot-assisted minimally invasive surgery (RAMIS) training']","['surgical technical skill acquisition', 'surgical technique metric', 'surgical technique', 'time and motion efficiency']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",30.0,0.0306309,"The experimental group showed more improvement than the control group on a surgical technique metric (at what angle is needle grasped by an instrument), and the difference between groups was statistically significant.
","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Malpani', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA. anandmalpani@jhu.edu.'}, {'ForeName': 'S Swaroop', 'Initials': 'SS', 'LastName': 'Vedula', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Intuitive Surgical Inc., 1020 Kifer Road, Sunnyvale, CA, 94086, USA.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Hager', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA.'}, {'ForeName': 'Russell H', 'Initials': 'RH', 'LastName': 'Taylor', 'Affiliation': 'Johns Hopkins University, 3400 N Charles St., Baltimore, MD, 21218, USA.'}]",International journal of computer assisted radiology and surgery,['10.1007/s11548-020-02156-5']
51,32385307,Randomized controlled trial of medium cut-off versus high-flux dialyzers on quality of life outcomes in maintenance hemodialysis patients.,"Medium cut-off (MCO) dialyzers help remove larger middle molecules associated with symptoms related to the accumulation of uremic retention solutes. We investigated the effect of an MCO dialyzer on the improvement of quality of life (QOL) in maintenance hemodialysis (HD) patients. Forty-nine HD patients with high-flux dialysis were randomly assigned to either an MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer and completed the study. QOL was assessed at baseline and after 12 weeks of treatment using the Kidney Disease Quality of Life Short Form-36, and pruritus was assessed using a questionnaire and visual analog scale. The reduction ratios of middle molecules were also evaluated. Laboratory markers, including serum albumin, did not differ between the two groups after 12 weeks. Removals of kappa and lambda free light chains were greater for MCO dialyzer than high-flux dialyzer. The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively). MCO dialyzers may improve patient-reported outcomes, particularly the physical components of QOL and uremic pruritus, in patients with high-flux dialyzers.",2020,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","['maintenance hemodialysis (HD) patients', 'maintenance hemodialysis patients', 'patients with high-flux dialyzers', 'Forty-nine HD patients with high-flux dialysis']","['Medium cut-off (MCO) dialyzers', 'MCO dialyzer', 'MCO (Theranova 400, Baxter) or a high-flux (FX CorDiax 80 or 60, Fresenius Medical Care) dialyzer', 'medium cut-off versus high-flux dialyzers', 'MCO dialyzers', 'MCO']","['reduction ratios of middle molecules', 'serum albumin', 'Removals of kappa and lambda free light chains', 'QOL', 'quality of life (QOL', 'questionnaire and visual analog scale', 'Kidney Disease Quality of Life Short Form-36, and pruritus', 'quality of life outcomes', 'frequency of scratching during sleep']","[{'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C1720314', 'cui_str': 'Lambda'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0587116', 'cui_str': 'During sleep'}]",49.0,0.0435656,"The MCO group had higher scores than the high-flux group in the domains of physical functioning and physical role (75.2 ± 20.8 vs. 59.8 ± 30.1, P = 0.042; 61.5 ± 37.6 vs. 39.0 ± 39.6, P = 0.047, respectively), and the MCO group had lower mean scores for morning pruritus distribution and the frequency of scratching during sleep (1.29 ± 0.46 vs. 1.64 ± 0.64, P = 0.034; 0.25 ± 0.53 vs. 1.00 ± 1.47, P = 0.023, respectively).","[{'ForeName': 'Jeong-Hoon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yeongwoo', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Department of Statistics, Kyungpook National University, Daegu, South Korea.'}, {'ForeName': 'Ju-Min', 'Initials': 'JM', 'LastName': 'Yook', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Soon-Youn', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hee-Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Ji-Young', 'Initials': 'JY', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Chan-Duck', 'Initials': 'CD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yong-Lim', 'Initials': 'YL', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Jang-Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Kyungpook National University, Kyungpook National University Hospital, Daegu, South Korea. jh-cho@knu.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-64622-z']
52,32385508,Psychosis-Relevant Effects of Intravenous Delta-9-Tetrahydrocannabinol: A Mega Analysis of Individual Participant-Data from Human Laboratory Studies.,"INTRODUCTION
There is increasing interest in the relationship between cannabinoids and psychosis. While individual human laboratory studies have been critical in demonstrating that cannabinoids (e.g., delta-9-tetrahydrocannabinol [THC]) can induce acute transient psychosis-like effects in healthy human volunteers, combining data from multiple studies offers a fine-grained view of these effects.
METHODS
THC-induced psychosis-relevant effects were examined using a data repository of 10 double-blind, randomized, placebo-controlled, crossover studies with 400 i.v. THC infusions in healthy human volunteers. The Positive and Negative Syndrome scale was used to measure psychotomimetic effects. The profile of symptoms, frequency of a response, its relationship to THC dose and substance use, latent structure in Positive and Negative Syndrome scale response, and the relationships between psychotomimetic and perceptual alteration symptoms were evaluated.
RESULTS
Clinically meaningful increases in positive symptoms were noted in 44.75% infusions; conceptual disorganization, hallucinations, blunted affect, somatic concern, motor retardation, and poor attention were the items most frequently altered by THC. The increase in Positive and Negative Syndrome scale positive symptoms was positively associated with THC dose (beta = 11.13, SE = 4.94, Wald χ 2 = 19.88, P < .001) and negatively associated with frequent cannabis use (beta = -0.575, SE = 0.14, Wald χ 2 = 18.13, P < .001). Furthermore, positive symptoms were strongly correlated with Clinician Administered Dissociative States Scale perceptual alterations score (rs = 0.514, P < .001).
CONCLUSION
Intravenous administration of THC consistently induces psychotomimetic effects that include symptoms across Positive and Negative Syndrome scale domains. Moreover, healthy individuals who frequently use cannabis have a blunted psychotomimetic response.",2020,"The increase in PANSS positive symptoms was positively associated with THC dose and (beta = 11.13, SE = 4.94, Wald χ2 = 19.88, p < 0.001) and negatively associated with frequent cannabis use (beta = -0.575, SE = 0.14, Wald χ2 = 18.13, p < 0.001).","['healthy subjects who frequently use cannabis', 'healthy human volunteers']","['THC', 'delta-9-tetrahydrocannabinol', 'intravenous delta-9-tetrahydrocannabinol', 'THC infusions', 'placebo']","['CADSS perceptual alterations score', 'somatic concern, motor retardation and poor attention', 'positive symptoms', 'Positive and Negative Syndrome scale (PANSS', 'PANSS positive symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}]",,0.223655,"The increase in PANSS positive symptoms was positively associated with THC dose and (beta = 11.13, SE = 4.94, Wald χ2 = 19.88, p < 0.001) and negatively associated with frequent cannabis use (beta = -0.575, SE = 0.14, Wald χ2 = 18.13, p < 0.001).","[{'ForeName': 'Suhas', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'Schizophrenia Neuropharmacology Research Group, VA Connecticut Healthcare System, West Haven, CT.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Cortes-Briones', 'Affiliation': 'Schizophrenia Neuropharmacology Research Group, VA Connecticut Healthcare System, West Haven, CT.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Schizophrenia Neuropharmacology Research Group, VA Connecticut Healthcare System, West Haven, CT.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Radhakrishnan', 'Affiliation': 'Schizophrenia Neuropharmacology Research Group, VA Connecticut Healthcare System, West Haven, CT.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Skosnik', 'Affiliation': 'Schizophrenia Neuropharmacology Research Group, VA Connecticut Healthcare System, West Haven, CT.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Schizophrenia Neuropharmacology Research Group, VA Connecticut Healthcare System, West Haven, CT.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa031']
53,32374959,Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke.,"BACKGROUND
In acute ischemic stroke, there is uncertainty regarding the benefit and risk of administering intravenous alteplase before endovascular thrombectomy.
METHODS
We conducted a trial at 41 academic tertiary care centers in China to evaluate endovascular thrombectomy with or without intravenous alteplase in patients with acute ischemic stroke. Patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation were randomly assigned in a 1:1 ratio to undergo endovascular thrombectomy alone (thrombectomy-alone group) or endovascular thrombectomy preceded by intravenous alteplase, at a dose of 0.9 mg per kilogram of body weight, administered within 4.5 hours after symptom onset (combination-therapy group). The primary analysis for noninferiority assessed the between-group difference in the distribution of the modified Rankin scale scores (range, 0 [no symptoms] to 6 [death]) at 90 days on the basis of a lower boundary of the 95% confidence interval of the adjusted common odds ratio equal to or larger than 0.8. We assessed various secondary outcomes, including death and reperfusion of the ischemic area.
RESULTS
Of 1586 patients screened, 656 were enrolled, with 327 patients assigned to the thrombectomy-alone group and 329 assigned to the combination-therapy group. Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%). Mortality at 90 days was 17.7% in the thrombectomy-alone group and 18.8% in the combination-therapy group.
CONCLUSIONS
In Chinese patients with acute ischemic stroke from large-vessel occlusion, endovascular thrombectomy alone was noninferior with regard to functional outcome, within a 20% margin of confidence, to endovascular thrombectomy preceded by intravenous alteplase administered within 4.5 hours after symptom onset. (Funded by the Stroke Prevention Project of the National Health Commission of the People's Republic of China and the Wu Jieping Medical Foundation; DIRECT-MT ClinicalTrials.gov number, NCT03469206.).",2020,"Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%).","['1586 patients screened, 656 were enrolled, with 327 patients assigned to the thrombectomy-alone group and 329 assigned to the combination-therapy group', 'Patients with acute ischemic stroke from large-vessel occlusion in the anterior circulation', 'Acute Stroke', 'patients with acute ischemic stroke', '41 academic tertiary care centers in China to evaluate', 'Chinese patients with acute ischemic stroke']","['Endovascular Thrombectomy with or without Intravenous Alteplase', 'endovascular thrombectomy with or without intravenous alteplase', 'endovascular thrombectomy alone (thrombectomy-alone group) or endovascular thrombectomy preceded by intravenous alteplase']","['Mortality', 'death and reperfusion of the ischemic area', 'distribution of the modified Rankin scale scores', 'overall successful reperfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0162578', 'cui_str': 'Removal of thrombus'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",656.0,0.189257,"Endovascular thrombectomy alone was noninferior to combined intravenous alteplase and endovascular thrombectomy with regard to the primary outcome (adjusted common odds ratio, 1.07; 95% confidence interval, 0.81 to 1.40; P = 0.04 for noninferiority) but was associated with lower percentages of patients with successful reperfusion before thrombectomy (2.4% vs. 7.0%) and overall successful reperfusion (79.4% vs. 84.5%).","[{'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongwei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongxin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Kilian M', 'Initials': 'KM', 'LastName': 'Treurniet', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Wenhuo', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Han', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jiyue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Shouchun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Congguo', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hongchao', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Xincan', 'Initials': 'X', 'LastName': 'Yue', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lou', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hansheng', 'Initials': 'H', 'LastName': 'Shu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Dianjing', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Kaifu', 'Initials': 'K', 'LastName': 'Ke', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Haicheng', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Huaizhang', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tianxiao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Zifu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xing', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qinghai', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Laixing', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yansheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Xihua', 'Initials': 'X', 'LastName': 'Zhong', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Longde', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Diederik W J', 'Initials': 'DWJ', 'LastName': 'Dippel', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Benqiang', 'Initials': 'B', 'LastName': 'Deng', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Yvo B W E M', 'Initials': 'YBWEM', 'LastName': 'Roos', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Charles B L M', 'Initials': 'CBLM', 'LastName': 'Majoie', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': 'Jianmin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""From the Departments of Neurosurgery (P.Y., L.Z., Yongxin Zhang, Z.L., Y. Zhou, Y.X., Q.H., R.Z., Q.L., Y.F., Laixing Wang, B.H., J. Liu), Neurology (Yongwei Zhang, P.X., P.Z., T.W., B.D.), and Radiology (J. Lu), Naval Medical University Changhai Hospital, the Department of Neurology, Shanghai Jiaotong University Renji Hospital (Y.L.), the Department of Neurology, Fudan University Huashan Hospital (J.F.), and the Data Statistics Center, Shanghai KNOWLANDS MedPharm Consulting (X.Z.), Shanghai, the Department of Neurology, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou (W.C.), the Department of Neurosurgery, Third Affiliated Hospital of Soochow University, Changzhou (Y.P.), the Department of Neurology, Linyi People's Hospital of Qingdao University, Linyi (H.H., H.W.), the Department of Neurosurgery, Liaocheng People's Hospital of Shandong First Medical University, Liaocheng (J.W.), the Department of Neurology, First Affiliated Hospital of Jilin University, Changchun (S.W.), the Department of Neurology, Hangzhou First People's Hospital of Zhejiang University (C.Y.), and the Department of Neurology, Second Affiliated Hospital of Zhejiang University (M.L.), Hangzhou, the Department of Radiology, Jiangsu Provincial People's Hospital of Nanjing Medical University (S.L.), and the Department of Neurology, Nanjing First Hospital of Nanjing Medical University (Hongchao Shi), Nanjing, the Department of Neurology, Taizhou First People's Hospital of Wenzhou Medical University, Taizhou (P.W.), the Department of Neurology, First Affiliated Hospital of Soochow University, Suzhou (Q.F.), the Department of Neurology, Ningbo Hospital of Zhejiang University, Ningbo (J.Y.), the Department of Neurology, Nanyang Central Hospital of Xinxiang Medical University, Nanyang (C.W.), the Department of Neurosurgery, First Hospital of Hebei Medical University, Shijiazhuang (C.L.), the Department of Neurology, Baotou Central Hospital of Inner Mongolia Medical University, Baotou (C.J.), the Department of Neurosurgery, Wenzhou Central Hospital of Wenzhou Medical University, Wenzhou (J.S.), the Department of Neurosurgery, Zhoukou Central Hospital of Henan University, Zhoukou (X.Y.), the Department of Neurology, Daping Hospital of Army Medical University, Chongqing (M.Z.), the Department of Neurosurgery, Second Affiliated Hospital of Bengbu Medical University, Bengbu (H. Shu), the Departments of Radiology (D.S.) and Neurology (H.L.), Yantaishan Hospital of Shandong First Medical University, Yantai, the Department of Neurology, Third Affiliated Hospital of Guangxi Medical University, Nanning (Tong Li), the Department of Neurology, Sichuan Provincial Hospital of University of Electronic Science and Technology of China, Chengdu (F.G.), the Department of Neurology, Affiliated Hospital of Nantong University, Nantong (K.K.), the Department of Neurology, Qingdao Central Hospital of Qingdao University, Qingdao (H.Y.), the Department of Neurology, First Affiliated Hospital of the University of Science and Technology of China (G.W.), and the Department of Neurology, First Affiliated Hospital of Anhui Medical University (W.Y.), Hefei, the Department of Neurosurgery, First Affiliated Hospital of Harbin Medical University, Harbin (Huaizhang Shi), the Department of Radiology, Henan Provincial People's Hospital of Zhengzhou University, Zhengzhou (Tianxiao Li), and the Department of Neurology, Capital Medical University Tiantan Hospital (Y.W.), and the School of Public Health, Beijing University (Longde Wang), Beijing - all in China; the Departments of Radiology and Nuclear Medicine (K.M.T., C.B.L.M.M.) and Neurology (Y.B.W.E.M.R.), Amsterdam University Medical Center, Amsterdam, and the Department of Neurology, Erasmus MC-University Medical Center, Rotterdam (D.W.J.D.) - both in the Netherlands; and the Departments of Radiology and Clinical Neurosciences, University of Calgary, Calgary, AB, Canada (M.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2001123']
54,32391862,A Multifaceted Antimicrobial Stewardship Program for the Treatment of Uncomplicated Cystitis in Nursing Home Residents.,"Importance
Urinary tract infections are the most common infections in nursing home residents. However, most antibiotic use is for unlikely cystitis (ie, nonspecific symptoms and positive culture results secondary to asymptomatic bacteriuria or a urine sample improperly collected for culture) that is unnecessary and inappropriate. This antibiotic use is associated with an increased risk of antimicrobial resistance, adverse drug events, and Clostridioides difficile (formerly Clostridium difficile) infections.
Objective
To determine the association of a multifaceted antimicrobial stewardship and quality improvement intervention with the reduction in unnecessary antimicrobial use for unlikely cystitis among noncatheterized nursing home residents.
Design, Setting, and Participants
A quality improvement intervention evaluation was conducted to target antimicrobial use among residents with unlikely cystitis in 25 nursing homes across the United States. Baseline data were collected between February 1, 2017, and April 30, 2017. The intervention was conducted from May 1, 2017, to April 30, 2018.
Interventions
Intervention nursing homes (n = 12) were randomized to receive a 1-hour introductory webinar, pocket-sized educational cards, tools for system change, and educational clinical vignettes addressing the diagnosis and treatment of suspected uncomplicated cystitis. Monthly web-based coaching calls were held for staff of intervention nursing homes. All facilities received quarterly feedback reports regarding the management of uncomplicated cystitis. Control group nursing homes (n = 13) received usual care.
Main Outcomes and Measures
The primary outcome was the incidence of antibiotic treatment for unlikely cystitis cases, defined using published criteria. Secondary outcomes included overall antibiotic use for any urinary tract infection and the safety outcomes of C difficile infections, as well as all-cause hospitalizations and death.
Results
Among the 25 nursing homes participating in this quality improvement study, including 512 408 intervention facility resident-days and 443 912 control facility resident-days, fewer unlikely cystitis cases were treated with antibiotics in intervention facilities compared with control facilities (adjusted incident rate ratio [AIRR], 0.73 [95% CI, 0.59-0.91]); C difficile infection rates were also lower in intervention nursing homes vs control nursing homes (AIRR, 0.35 [95% CI, 0.19-0.64]). Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83 [95% CI, 0.70-0.99]; P = .04). There was no increase in all-cause hospitalizations or deaths due to the intervention (all-cause hospitalizations: AIRR, 0.95 [95% CI, 0.75-1.19]; all-cause death: AIRR, 0.92 [95% CI, 0.73-1.16]).
Conclusions and Relevance
This study suggests that a low-intensity, multifaceted intervention was associated with improved antibiotic prescribing for uncomplicated cystitis in a cohort of nursing homes without an adverse association with other safety outcomes. Although promising, further study is needed to determine whether the intervention could be widely implemented to assist facilities in meeting new federal nursing home requirements for antimicrobial stewardship and quality assurance performance improvement programs.",2020,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","['25 nursing homes participating', 'noncatheterized nursing home residents', 'residents with unlikely cystitis in 25 nursing homes across the United States', 'Interventions\n\n\nIntervention nursing homes (n\u2009=\u200912', 'nursing home residents', 'Uncomplicated Cystitis in Nursing Home Residents']","['Multifaceted Antimicrobial Stewardship Program', '1-hour introductory webinar, pocket-sized educational cards, tools for system change, and educational clinical vignettes addressing the diagnosis and treatment of suspected uncomplicated cystitis', 'usual care']","['Overall antibiotic use', 'incidence of antibiotic treatment for unlikely cystitis cases', 'overall antibiotic use for any urinary tract infection and the safety outcomes of C difficile infections, as well as all-cause hospitalizations and death', 'urinary tract infection', 'C difficile infection rates']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0698375,"Overall antibiotic use for any type of urinary tract infection was 17% lower in the intervention facilities than the control facilities (AIRR, 0.83","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hanlon', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Crnich', 'Affiliation': 'Division of Infectious Diseases, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Drinka', 'Affiliation': 'Division of Internal Medicine and Geriatrics, University of Wisconsin, Madison.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Schweon', 'Affiliation': 'Infection Prevention Consultant, Saylorsburg, Pennsylvania.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Anderson', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.1256']
55,32333060,Letter to the editor: Impact of postoperative instructions on physical activity following pelvic reconstructive surgery: a randomized controlled trial.,,2020,,['pelvic reconstructive surgery'],['postoperative instructions'],['physical activity'],"[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.175555,,"[{'ForeName': 'Chih-Ting', 'Initials': 'CT', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kun-Ling', 'Initials': 'KL', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Long', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. urolong@yahoo.com.tw.'}]",International urogynecology journal,['10.1007/s00192-020-04316-2']
56,32398710,Metacognitive Therapy versus Cognitive Behaviour Therapy in Adults with Major Depression: A Parallel Single-Blind Randomised Trial.,"In the last forty years therapy outcomes for depression have remained the same with approximately 50% of patients responding to treatments. Advances are urgently required. We hypothesised that a recent treatment, metacognitive therapy (MCT), might be more effective, by targeting mental control processes that directly contribute to depression. We assessed the clinical efficacy of MCT compared to current best psychotherapy practice, CBT, in adults with major depressive disorder. A parallel randomized single-blind trial was conducted in a primary care outpatient setting. This trial is registered with the ISCRTN registry, number ISRCTN82799488. In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part. 85 were randomly allocated to MCT and 89 to CBT. Randomisation was performed independently following pre-treatment assessment and was stratified for severity of depression (low < 20 vs high > =20) on the Hamilton Depression Rating Scale (HDRS) and on sex (male/female). Assessors and trial statisticians were blind to treatment allocation. Each treatment arm consisted of up to 24 sessions of up to 60 minutes each, delivered by trained clinical psychologists. The co-primary outcome measures were assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II) at post treatment. Secondary outcomes were scores six months post treatment on these measures and a range of symptom and mechanism variables. A key trial design feature was that each treatment was implemented to maximize individual patient benefit; hence time under therapy and number of sessions delivered could vary. Treated groups in the trial were very similar on most baseline characteristics. Data were analyzed on the basis of intention to treat (ITT). No differences were found on the HDRS at post treatment or follow-up (-0.95 [-2.88 to 0.98], p = 0.336; and -1.61 [-3.65 to 0.43], p = 0.122), but floor effects on this outcome were high. However, a significant difference favouring MCT was found on the BDI-II at post treatment (-5.49 [95% CI -8.90 to -2.08], p = 0.002), which was maintained at six-month follow-up (-4.64 [-8.21 to -1.06], p = 0.011). Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-ratio=2.42 [1.20 to 4.92], p = 0.014). At follow-up the proportions were 74% compared to 56% recovery (odds-ratio=2.19 [1.05 to 4.54], p = 0.036). Significant differences favouring MCT, also maintained over time, were observed for most secondary outcomes. The results were robust against controlling for time under therapy and when outcomes were assessed at a common 90 day mid-term time-point. Limitations of the study include the use of only two therapists where one treated 69% of patients, possible allegiance effects as the study was conducted in an established CBT clinic and the chief investigator is the originator of MCT and group differences in time under therapy. Never the less evidence from this study suggests that MCT had considerable beneficial effects in treating depression that may exceed CBT.",2020,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"['In total 174 adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder were eligible and consented to take part', 'primary care outpatient setting', 'Adults with Major Depression', 'adults with major depressive disorder']","['metacognitive therapy (MCT', 'Metacognitive Therapy versus Cognitive Behaviour Therapy', 'MCT']","['range of symptom and mechanism variables', 'MCT', 'Hamilton Depression Rating Scale (HDRS', 'assessor rated symptom severity on the HDRS and self-reported symptom severity on the Beck Depression Inventory II (BDI-II', 'HDRS']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",174.0,0.0879843,Following MCT 74% of patients compared with 52% in CBT met formal criteria for recovery on the BDI-II at post treatment (odds-,"[{'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Callesen', 'Affiliation': 'Cektos - Center for Kognitiv - og Metakognitiv Terapi, Riddergade 7, 1 sal, 4700, Næstved, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reeves', 'Affiliation': 'University of Manchester, NIHR School for Primary Care Research, Manchester Academic Health Sciences Centre, Williamson Building, Manchester, M13 9PL, UK.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Heal', 'Affiliation': 'University of Manchester, Centre for Biostatistics, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences Centre, Manchester, M13 9PL, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wells', 'Affiliation': 'University of Manchester, School of Psychological Sciences, Faculty of Biology, Medicine and Health, Rawnsley Building, MRI, Manchester, M13 9WL, UK. adrian.wells@manchester.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-64577-1']
57,32398738,"Impact of different cord clamping strategies on short term neuromonitoring among preterm infants: a randomized, controlled trial.",,2020,,['preterm infants'],['cord clamping strategies'],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]",[],,0.201929,,"[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Agarwal', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA. pagarwal@dmc.org.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': ""Children's Research Center of Michigan, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}, {'ForeName': 'Girija', 'Initials': 'G', 'LastName': 'Natarajan', 'Affiliation': ""Division of Neonatal-Perinatal Medicine, Department of Pediatrics, Children's Hospital of Michigan/Wayne State University, Detroit, MI, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0684-3']
58,32325415,Whole-body vibration and stretching enhances dorsiflexion range of motion in individuals with chronic ankle instability.,"OBJECTIVE
The purpose of this study was to determine if WBV performed concurrently with static stretching was more effective than static stretching alone to increase dorsiflexion ROM (DFROM) in individuals with chronic ankle instability (CAI).
DESIGN
Controlled laboratory study.
PARTICIPANTS
Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score) were divided into 3 groups (normative (N), static stretch (SS), and static stretch with vibration (SV)). Participants stretched the triceps surae 4 days/wk for 3 wks. Vibration was imposed at 34 Hz and 1.8 mm.
MAIN OUTCOME MEASURES
DFROM was assessed in a straight and bent-leg position.
RESULTS
No differences were detected at any time in the N or SS group, however SS did exhibit large effect sizes with 95% confidence intervals (CI) that did not cross zero from baseline to 3 weeks for both measures. The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
CONCLUSIONS
Static stretching with WBV increases DFROM in participants with CAI more effectively than static stretching alone.",2020,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","['participants with CAI', 'individuals with chronic ankle instability', 'Thirty-nine participants with CAI (history of ankle sprain, a feeling of ""giving way"" during activity, and a qualifying Foot and Ankle Ability Measure Ankle score', 'individuals with chronic ankle instability (CAI']","['static stretch (SS), and static stretch with vibration (SV', 'static stretching', 'static stretching alone']","['DFROM', 'dorsiflexion ROM (DFROM', 'DFROM was assessed in a straight and bent-leg position']","[{'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}]","[{'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}]",39.0,0.0500288,"The SV group demonstrated increased DFROM from baseline for both time points and a large effect size with 95% CI that did not cross zero from post tx-1 to post tx-2.
","[{'ForeName': 'Feland', 'Initials': 'F', 'LastName': 'Jb', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: brent_feland@byu.edu.'}, {'ForeName': 'Thalman', 'Initials': 'T', 'LastName': 'Lesley', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: lesleyabigail@gmail.com.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'I', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: iain_hunter@byu.edu.'}, {'ForeName': 'Cochrane', 'Initials': 'C', 'LastName': 'Dj', 'Affiliation': 'School of Sport, Exercise & Nutrition, Massey University, New Zealand. Electronic address: D.Cochrane@massey.ac.nz.'}, {'ForeName': 'Hopkins', 'Initials': 'H', 'LastName': 'Jt', 'Affiliation': 'College of Life Sciences, Department of Exercise Sciences, SFH-106, Brigham Young University, Provo, UT, 84602, USA. Electronic address: tyhopkins@byu.edu.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.04.001']
59,32385847,A Pilot and Feasibility Mobile Health Intervention to Support Healthy Behaviors in African American Breast Cancer Survivors.,"African American breast cancer (AA BC) survivors are more likely to have cancer-related comorbidities compared with other women, ultimately putting them at higher risk for overall mortality and breast cancer-specific mortality. Survivorship care guidelines emphasize the importance of attention to obesity, weight management, and physical activity. Mobile technologies have been effective for improving health behaviors among cancer survivors, though few studies have focused on AA BC survivors. Creating Healthy Actions through Technology (CHAT) was a 4-week pilot intervention that employed an ecological momentary assessment (EMA) to improve survivors' physical activity and diet behaviors. We evaluated the acceptability, feasibility, and impact of a mHealth intervention for AA BC survivors. Participants (N = 22) were randomized to intervention (n = 13) or control (n = 9). All participants completed daily EMAs via smartphone for 4 weeks and wore accelerometers for seven consecutive days at baseline, 4, and 8 weeks. Intervention participants additionally received tailored health messages. Diet was measured using a self-reported questionnaire and physical activity with accelerometers. Participant engagement was high. Of 84 EMA assessments, the average response was 63 (SD 16.1). Participant accelerometer wear was at least 6 of the 7 days (SD 1.7) for each assessment. Eighty-five percent of participants reported the intervention helped change behaviors. Intervention participants reduced their sedentary time by 4.37 (SD = 7.14) hours/day versus controls (p = .05), reduced fast food intake by 1.5 servings (p = 0.008), and increased vigorous activity by 0.56 (SD = 28.10) minutes, which was non-significant (p = 0.959). Findings show feasibility and acceptability and potential of the intervention to positively impact physical activity among AA BC survivors.",2020,"Intervention participants reduced their sedentary time by 4.37 (SD = 7.14) hours/day versus controls (p = .05), reduced fast food intake by 1.5 servings (p = 0.008), and increased vigorous activity by 0.56 (SD = 28.10) minutes, which was non-significant (p = 0.959).","['AA BC survivors', 'African American breast cancer (AA BC) survivors', 'Participants (N\u2009=\u200922', 'cancer survivors', 'African American Breast Cancer Survivors']","['tailored health messages', 'Feasibility Mobile Health Intervention', 'ecological momentary assessment (EMA', 'mHealth intervention', 'Technology']","['reduced fast food intake', 'vigorous activity', 'sedentary time', ""survivors' physical activity and diet behaviors"", 'average response', 'health behaviors']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0559593', 'cui_str': 'Convenience food intake'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0666138,"Intervention participants reduced their sedentary time by 4.37 (SD = 7.14) hours/day versus controls (p = .05), reduced fast food intake by 1.5 servings (p = 0.008), and increased vigorous activity by 0.56 (SD = 28.10) minutes, which was non-significant (p = 0.959).","[{'ForeName': 'Marlyn', 'Initials': 'M', 'LastName': 'Allicock', 'Affiliation': 'School of Public Health, University of Texas Health Sciences Center at Houston, Houston, TX, USA. Marlyn.A.Allicock@uth.tmc.edu.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Kendzor', 'Affiliation': 'The University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Sedory', 'Affiliation': 'School of Public Health, University of Texas Health Sciences Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kelley Pettee', 'Initials': 'KP', 'LastName': 'Gabriel', 'Affiliation': 'School of Public Health, University of Texas Health Sciences Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Swartz', 'Affiliation': 'School of Public Health, University of Texas Health Sciences Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': 'School of Public Health, University of Texas Health Sciences Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Yudkin', 'Affiliation': 'School of Public Health, University of Texas Health Sciences Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Aeisha', 'Initials': 'A', 'LastName': 'Rivers', 'Affiliation': 'Memorial Breast Cancer Center, Memorial Regional Hospital, Memorial Hospital West, Hollywood, FL, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00767-x']
60,32387716,Hypertension during Diabetic Ketoacidosis in Children.,"OBJECTIVES
To characterize hemodynamic alterations occurring during diabetic ketoacidosis (DKA) in a large cohort of children and to identify clinical and biochemical factors associated with hypertension.
STUDY DESIGN
This was a planned secondary analysis of data from the Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation in DKA Study, a randomized clinical trial of fluid resuscitation protocols for children in DKA. Hemodynamic data (heart rate, blood pressure) from children with DKA were assessed in comparison with normal values for age and sex. Multivariable statistical modeling was used to explore clinical and laboratory predictors of hypertension.
RESULTS
Among 1258 DKA episodes, hypertension was documented at presentation in 154 (12.2%) and developed during DKA treatment in an additional 196 (15.6%), resulting in a total of 350 DKA episodes (27.8%) in which hypertension occurred at some time. Factors associated with hypertension at presentation included more severe acidosis, (lower pH and lower pCO 2 ), and stage 2 or 3 acute kidney injury. More severe acidosis and lower Glasgow Coma Scale scores were associated with hypertension occurring at any time during DKA treatment.
CONCLUSIONS
Despite dehydration, hypertension occurs in a substantial number of children with DKA. Factors associated with hypertension include greater severity of acidosis, lower pCO 2, and lower Glasgow Coma Scale scores during DKA treatment, suggesting that hypertension might be centrally mediated.",2020,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","['children with DKA', 'children in DKA', 'Hypertension During Diabetic Ketoacidosis in Children']",[],"['severity of acidosis, lower PCO 2 and lower GCS scores', 'Hemodynamic data (heart rate, blood pressure', 'severe acidosis and lower Glasgow Coma Scale (GCS) scores', 'hypertension']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.0665684,"More severe acidosis and lower Glasgow Coma Scale (GCS) scores were associated with hypertension occurring at any time during DKA treatment.
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Nemours/A.I. DuPont Hospital for Children, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA; Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's National Medical Center, The George Washington School of Medicine and Health Sciences, Washington, DC.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, The Colorado Children's Hospital, University of Colorado-Denver School of Medicine, Denver, CO.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University School of Medicine, Columbus, OH.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA.'}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine in St. Louis, St. Louis, MO.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, New York Presbyterian Morgan Stanley Children's Hospital, Columbia University College of Physicians and Surgeons, New York, NY.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, University of California Davis, Sacramento, CA.'}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': 'Department of Pediatrics, University of California Davis Health, University of California Davis, School of Medicine, Sacramento, CA. Electronic address: nsglaser@ucdavis.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.066']
61,32331738,The effect of deep breathing relaxation to reduce post operative pain in lower limb fracture.,"OBJECTIVE
This study was performed to determine the effect of deep breathing relaxation to reduce post operative pain in lower limb fracture.
METHOD
This a quasi experiment with a pretest-posttest intervention control group design. Accidental sampling used and consisted of 16 respondents who were divided into two groups (each n=8), intervention and control group. Measurement of pain intensity used Numerical Rating Scale (NRS), in intervention and control group after 4h of analgesic administration.
RESULT
Demographic data showed most of respondent were male (43.75%) with age early adulthood (62.5%) and dominan tribe is from Sumatrans (43.75%). There was effect of deep breathing exercise to reduce post operative pain in lower limb fracture, obtained p value=0.000 (p<0.05).
CONCLUSION
Deep breathing relaxation is recommended and suggested intervention to reduce post operative pain in lower limb fracture.",2020,"There was effect of deep breathing exercise to reduce post operative pain in lower limb fracture, obtained p value=0.000 (p<0.05).
",['lower limb fracture'],"['deep breathing relaxation', 'deep breathing exercise']",['pain intensity used Numerical Rating Scale (NRS'],"[{'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}]","[{'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",16.0,0.0211949,"There was effect of deep breathing exercise to reduce post operative pain in lower limb fracture, obtained p value=0.000 (p<0.05).
","[{'ForeName': 'Apri', 'Initials': 'A', 'LastName': 'Sunadi', 'Affiliation': 'University of Respati Indonesia, Indonesia. Electronic address: afri_sunadi@yahoo.com.'}, {'ForeName': 'Erlin', 'Initials': 'E', 'LastName': 'Ifadah', 'Affiliation': 'University of Respati Indonesia, Indonesia.'}, {'ForeName': 'Miftah Nur Okta', 'Initials': 'MNO', 'LastName': 'Syarif', 'Affiliation': 'University of Respati Indonesia, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.045']
62,32399799,Effect of FAmily CEntered (FACE®) Advance Care Planning on Longitudinal Congruence in End-of-Life Treatment Preferences: A Randomized Clinical Trial.,"Trial tested effect of advance care planning on family/surrogates' understanding of patients' end-of-life treatment preferences longitudinally. A multisite, assessor-blinded, intent-to-treat, parallel-group, randomized controlled clinical trial in five hospital-based HIV clinics enrolled 449 participants aged 22 to 77 years during October 2013-March 2017. Patients living with HIV/family dyads were randomized at 2:1 ratio to 2 weekly ~ 60-min sessions either ACP (n = 155 dyads)-(1) ACP facilitated conversation, (2) Advance directive completion; or Control (n = 68 dyads)-(1) Developmental/relationship history, (2) Nutrition/exercise tips. ACP families/surrogates were more likely to accurately report patients' treatment preferences at Time 1 (T 1 ) and 12 months post-intervention (T 2 ) compared to controls, experiencing high congruence longitudinally (high→high transition), [63·6% vs 37·7% (difference = 25·9%, 95% CI: 11·3%, 40·4%, χ 2 = 11·52, p = 0·01)], even as patients' preferences changed over time. ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3). Conversations matter.",2020,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","['five hospital-based HIV clinics enrolled 449 participants aged 22 to 77\xa0years during October 2013-March 2017', 'Patients living with HIV/family dyads', 'Longitudinal Congruence in End-of-Life Treatment Preferences']","['Control (n\u2009=\u200968 dyads)-(1', 'FAmily CEntered (FACE®', 'ACP (n\u2009=\u2009155 dyads)-(1', 'advance care planning', 'Advance Care Planning']",[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001369', 'cui_str': 'Acyl Carrier Protein'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}]",[],449.0,0.0733186,"ACP families/surrogates had eight times the odds of controls of having an excellent understanding of patients' treatment preferences (Adjusted Odds Ratio 7.91, 95%CI: 3.08, 20.3).","[{'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA. mlyon@childrensnational.org.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Squires', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington, DC, USA.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Scott', 'Affiliation': 'MedStar: Health Research Institute and Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Benator', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Briggs', 'Affiliation': 'Respecting Choices, Coalition to Transform Advance Care Innovations, Washington, DC, USA.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Greenberg', 'Affiliation': ""Medical Education, Children's National, Washington, DC, USA.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Yao Iris', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics & Study Methodology, Center for Translational Research/Children's Research Institute, Washington, DC, USA.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02909-y']
63,32335086,A Novel Perineal Nerve Block Approach for Transperineal Prostate Biopsy: An Anatomical Analysis-based Randomized Single-blind Controlled Trial.,"OBJECTIVE
To develop and validate a novel perineal nerve block approach for transperineal prostate biopsy.
PATIENTS AND METHODS
Five adult male cadavers were dissected to delineate the superficial and deep branches of the perineal nerve. Afterwards, 90 out of 115 patients were selected and randomly assigned to receive periprostatic, periapical triangle, or branches of perineal nerve (BPN) block. The primary outcome was the maximal pain intensity associated with transperineal prostate biopsy, which was assessed by the 10-point visual analog scale. The secondary outcomes included the number of biopsy with visual analog scale of ≥4 in each biopsy procedure, and the incidences of complications.
RESULTS
On the horizontal line of the upper anal border, the locations of the superficial branch of perineal nerve on the left and right sides were 1.87 ± 0.05 cm and 1.86 ± 0.06 cm, respectively; and the deep branch were 2.15 ± 0.07 cm and 2.16 ± 0.06 cm, respectively, from the midline, and lied between the deep layer of superficial fascia and prostate capsule. The number of cases finally enrolled in data analysis in periprostatic block, periapical triangle block, and BPN block groups were 26, 27, and 30, respectively. The maximal pain intensities were 3.4 (3.1-3.7), 3.3 (3.0-3.6), and 1.8 (1.5-2.2) in the 3 groups, respectively, and the numbers of biopsy with the pain intensity of ≥4 were 4.0 (3.2-4.9), 4.2 (3.3-5.2), and 0.7 (0.1-1.2), respectively. There were 4, 3 and 4 cases developing hematuria, and 1, 1 and 2 burdened with urine retention after biopsy in the 3 groups, respectively.
CONCLUSION
Collectively, BPN block is a safe, effective and repeatable local anesthesia approach for transperineal prostate biopsy.",2020,"Collectively, BPN block is a safe, effective and repeatable local anesthesia approach for transperineal prostate biopsy.","['Five adult male cadavers', '90 out of 115 patients']","['Transperineal Prostate Biopsy', 'periprostatic, periapical triangle (PAT), or branches of perineal nerve (BPN) block', 'Novel Perineal Nerve Block Approach']","['maximal pain intensities', 'urine retention', 'numbers of biopsy with the pain intensity', 'maximal pain intensity associated with transperineal prostate biopsy, which was assessed by the 10-point VAS', 'number of biopsy with VAS of >=4 in each biopsy procedure, and the incidences of complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205500', 'cui_str': 'Perineal approach'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0228961', 'cui_str': 'Structure of perineal nerve'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0449807', 'cui_str': 'Number of biopsies'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205500', 'cui_str': 'Perineal approach'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",115.0,0.107247,"Collectively, BPN block is a safe, effective and repeatable local anesthesia approach for transperineal prostate biopsy.","[{'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hengzhi', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Biming', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Department of Urology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaodan', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Anatomy, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Xi', 'Affiliation': 'Department of Anesthesiology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Anatomy, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Husheng', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Guangan', 'Initials': 'G', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Maoyu', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhenkai', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Sheng', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Chuanliang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China. Electronic address: 446720864@qq.com.'}]",Urology,['10.1016/j.urology.2020.01.058']
64,32386922,Stability of acute responses to drugs in humans across repeated testing: Findings with alcohol and amphetamine.,"BACKGROUND
Controlled drug challenge studies provide valuable information about the acute behavioral effects of drugs, including individual differences that may affect risk for abuse. One question that arises in such studies is whether a single administration of a drug (and placebo) provides an accurate measure of response to the drug.
METHODS
Here, we examined data from two studies, one with alcohol and one with amphetamine, in which participants received two administrations of the drug and placebo. In this analysis we assess the stability of acute subjective and cardiovascular responses to the drugs across the two administrations. We examine i) systematic increases or decreases to the drugs from the first to the second administration, ii) test-retest reliability within individuals and iii) the accuracy of the acute drug responses to predict drug choice in a later session.
RESULTS
Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies. Test-retest reliability within individuals was high. Responses during the first drug administration were as accurate in predicting drug choice as responses during both administrations combined.
CONCLUSIONS
Our findings indicate that a single administration of drug (and placebo) provides a good index of an individual's responses to alcohol or amphetamine, when participants are tested under controlled experimental conditions.",2020,"RESULTS
Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.",[],"['drug (and placebo', 'amphetamine', 'placebo']",['stability of acute subjective and cardiovascular responses'],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",,0.0465427,"RESULTS
Responses were largely stable across sessions, although on the second session amphetamine ""liking"" was higher, and subjective responses to placebo including ""liking"" and ""want more"" decreased in both studies.","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Ave MC3077, Chicago, IL 60637 USA. Electronic address: hdew@uchicago.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107989']
65,32334703,"Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial.","BACKGROUND
Current guidelines recommend potent platelet inhibition with ticagrelor or prasugrel in patients after an acute coronary syndrome. However, data about optimal platelet inhibition in older patients are scarce. We aimed to investigate the safety and efficacy of clopidogrel compared with ticagrelor or prasugrel in older patients with non-ST-elevation acute coronary syndrome (NSTE-ACS).
METHODS
We did the open-label, randomised controlled POPular AGE trial in 12 sites (ten hospitals and two university hospitals) in the Netherlands. Patients aged 70 years or older with NSTE-ACS were enrolled and randomly assigned in a 1:1 ratio using an internet-based randomisation procedure with block sizes of six to receive a loading dose of clopidogrel 300 mg or 600 mg, or ticagrelor 180 mg or prasugrel 60 mg, and then a maintenance dose for the duration of 12 months (clopidogrel 75 mg once daily, ticagrelor 90 mg twice daily, or prasugrel 10 mg once daily) on top of standard care. Patient and treating physicians were aware of the allocated treatment strategy, but the outcome assessors were masked to treatment allocation. Primary bleeding outcome consisted of PLATelet inhibition and patient Outcomes (PLATO; major or minor bleeding [superiority hypothesis]). Co-primary net clinical benefit outcome consisted of all-cause death, myocardial infarction, stroke, PLATO major and minor bleeding (non-inferiority hypothesis, margin of 2%). Follow-up duration was 12 months. Analyses were done on intention-to-treat basis. This trial is registered with the Netherlands Trial Register (NL3804), ClinicalTrials.gov (NCT02317198), and EudraCT (2013-001403-37).
FINDINGS
Between June 10, 2013, and Oct 17, 2018, 1002 patients were randomly assigned to clopidogrel (n=500) or ticagrelor or prasugrel (n=502). Because 475 (95%) patients received ticagrelor in the ticagrelor or prasugrel group, we will refer to this group as the ticagrelor group. Premature discontinuation of the study drug occurred in 238 (47%) of 502 ticagrelor group patients randomly assigned to ticagrelor, and in 112 (22%) of 500 patients randomly assigned to clopidogrel. Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] of 502; hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority). Co-primary net clinical benefit outcome was non-inferior for the use of clopidogrel (139 [28%]) versus ticagrelor (161 [32%]; absolute risk difference -4%, 95% CI -10·0 to 1·4; p=0·03 for non-inferiority). The most important reasons for discontinuation were occurrence of bleeding (n=38), dyspnoea (n=40), and the need for treatment with oral anticoagulation (n=35).
INTERPRETATION
In patients aged 70 years or older presenting with NSTE-ACS, clopidogrel is a favourable alternative to ticagrelor, because it leads to fewer bleeding events without an increase in the combined endpoint of all-cause death, myocardial infarction, stroke, and bleeding. Clopidogrel could be an alternative P2Y12 inhibitor especially for elderly patients with a higher bleeding risk.
FUNDING
ZonMw.",2020,"Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] of 502; hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority).","['12 sites (ten hospitals and two university hospitals) in the Netherlands', 'Between June 10, 2013, and Oct 17, 2018, 1002 patients', 'patients after an acute coronary syndrome', 'patients aged 70 years or older presenting with NSTE-ACS', 'patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE', 'older patients', 'Patients aged 70 years or older with NSTE-ACS', 'older patients with non-ST-elevation acute coronary syndrome (NSTE-ACS', 'elderly patients with a higher bleeding risk']","['clopidogrel', 'ticagrelor', 'Clopidogrel versus ticagrelor or prasugrel', 'clopidogrel 75 mg once daily, ticagrelor 90 mg twice daily, or prasugrel 10 mg once daily) on top of standard care', 'ticagrelor or prasugrel', 'Clopidogrel', 'clopidogrel 300 mg or 600 mg, or ticagrelor 180 mg or prasugrel']","['PLATelet inhibition and patient Outcomes (PLATO; major or minor bleeding [superiority hypothesis', 'death, myocardial infarction, stroke, PLATO major and minor bleeding', 'safety and efficacy', 'Primary bleeding outcome']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1124675', 'cui_str': 'clopidogrel 75 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3163568', 'cui_str': 'Ticagrelor 90 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C2710118', 'cui_str': 'prasugrel 10 MG'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1968319', 'cui_str': 'clopidogrel 300 MG'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043566', 'cui_str': '(1,2-diamino-4-nitrobenzene)dichloroplatinum(II)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1002.0,0.222636,"Primary bleeding outcome was significantly lower in the clopidogrel group (88 [18%] of 500 patients) than in the ticagrelor group (118 [24%] of 502; hazard ratio 0·71, 95% CI 0·54 to 0·94; p=0·02 for superiority).","[{'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Gimbel', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Qaderdan', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Willemsen', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Hermanides', 'Affiliation': 'Department of Cardiology, Isala Hospitals, Zwolle, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bergmeijer', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'de Vrey', 'Affiliation': 'Department of Cardiology, Meander Medical Centre, Amersfoort, Netherlands.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord-west Hospital group, Alkmaar, Netherlands.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Tjon Joe Gin', 'Affiliation': 'Department of Cardiology, Rijnstate, Arnhem, Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Waalewijn', 'Affiliation': 'Department of Cardiology, Gelre Hospitals, Apeldoorn, Netherlands.'}, {'ForeName': 'Sjoerd', 'Initials': 'S', 'LastName': 'Hofma', 'Affiliation': 'Department of Cardiology, Medical Centre Leeuwarden, Leeuwarden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'den Hartog', 'Affiliation': 'Department of Cardiology, Gelderse Vallei Hospital, Ede, Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leids University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Kelder', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Deneer', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands; Department of Clinical Pharmacy, Division of Laboratories, Pharmacy, and Biomedical Genetics University Medical Center Utrecht and Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Jurriën', 'Initials': 'J', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands. Electronic address: j.ten.berg@antoniusziekenhuis.nl.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30325-1']
66,32321483,Early palliative care versus standard care in haematologic cancer patients at their last active treatment: study protocol of a feasibility trial.,"BACKGROUND
Patients with advanced haematological malignancies suffer from a very high symptom burden and psychological, spiritual, social and physical symptoms comparable with patients with metastatic non-haematological malignancy. Referral to palliative care services for these patients remains limited or often confined to the last days of life. We developed a palliative care intervention (PCI) integrated with standard haematological care. The aim of the study was focussed on exploring the feasibility of the intervention by patients, professionals and caregivers and on assessing its preliminary efficacy.
METHODS/DESIGN
This is a mixed-methods phase 2 trial. The Specialist Palliative Care Team (SPCT) will follow each patient on a monthly basis in the outpatient clinic or will provide consultations during any hospital admission. SPCT and haematologists will discuss active patient issues to assure a team approach to the patient's care. This quantitative study is a monocentric parallel-group superiority trial with balanced randomisation comparing the experimental PCI plus haematological standard care versus haematological standard care alone. The primary endpoint will calculate on adherence to the planned PCI, measured as the percentage of patients randomised to the experimental arm who attend all the planned palliative care visits in the 24 weeks after randomisation. The qualitative study follows the methodological indications of concurrent nested design and was aimed at exploring the acceptability of the PCI from the point of view of patients, caregivers and physicians.
DISCUSSION
In this trial, we will test the feasibility of an integrated palliative care approach starting when the haematologist decides to propose the last active treatment to the patient, according to his/her clinical judgement. We decided to test this criterion because it is able to intercept a wide range of patients'needs. The feasibility of this approach requires that we enrol at least 60 patients and that more than 50% of them be followed by the palliative care team for at least 24 weeks. The trial will include integrated qualitative data analysis; to give essential information on feasibility and acceptability.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03743480 (November 16, 2018).",2020,"The primary endpoint will calculate on adherence to the planned PCI, measured as the percentage of patients randomised to the experimental arm who attend all the planned palliative care visits in the 24 weeks after randomisation.","['enrol at least 60 patients and that more than 50% of them be followed by the palliative care team for at least 24\u2009weeks', 'haematologic cancer patients', 'Patients with advanced haematological malignancies suffer from a very high symptom burden and psychological, spiritual, social and physical symptoms comparable with patients with metastatic non-haematological malignancy']","['PCI plus haematological standard care versus haematological standard care alone', 'palliative care intervention (PCI) integrated with standard haematological care']",['adherence to the planned PCI'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0442804', 'cui_str': 'Very high'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.11812,"The primary endpoint will calculate on adherence to the planned PCI, measured as the percentage of patients randomised to the experimental arm who attend all the planned palliative care visits in the 24 weeks after randomisation.","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Tanzi', 'Affiliation': 'Palliative Care Unit, Azienda USL-IRCCS di Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy. silvia.tanzi@ausl.re.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Luminari', 'Affiliation': 'Haematology Department, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Cavuto', 'Affiliation': 'Clinical Trials an Statistics Unit, Infrastructure Research and Statistic, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Turola', 'Affiliation': 'Palliative Care Unit, Azienda USL-IRCCS di Reggio Emilia, Viale Risorgimento 80, 42123, Reggio Emilia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Ghirotto', 'Affiliation': 'Qualitative Research Unit, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Costantini', 'Affiliation': 'Scientific Directorate, Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.'}]",BMC palliative care,['10.1186/s12904-020-00561-w']
67,32213737,Long-Term Outcomes of Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent - A Randomized Comparison Through 5 Years in Japan.,"BACKGROUND
Bioresorbable vascular scaffolds (BVS) are promising alternatives to metallic drug-eluting stents (DES) in percutaneous coronary interventions. Absorb BVS was comparable to XIENCE (DES) for patient- and device-oriented composite endpoints through 1 year post-procedure. Mid-term results showed increased rates of device-oriented events with Absorb. The objective of this study was to evaluate the long-term safety and effectiveness of Absorb BVS compared with XIENCE metallic DES when implanted in patients in Japan with de novo coronary artery lesions.Methods and Results:ABSORB Japan randomized 400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm. Through 5-year follow-up, the composite endpoints of DMR (death, myocardial infarction [MI], and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI were evaluated. Individual endpoints included death, MI, coronary revascularization, and scaffold/stent thrombosis. There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years. Numerically lower TVF, MACE, and all MI rates were observed for the Absorb vs. XIENCE arm after 3 years. No scaffold/stent thrombosis was reported beyond 3 years. Post-procedure imaging subgroups showed comparable event rates.
CONCLUSIONS
Following resorption of the scaffold, between 3 and 5 years post-procedure, the Absorb BVS performed comparably to XIENCE in all patient- and device-oriented endpoints (ClinicalTrials.gov, #NCT01844284).",2020,There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years.,"['patients in Japan with de novo coronary artery lesions', '400 patients into either Absorb (n=266) or XIENCE (n=134) treatment arm']","['Absorb Bioresorbable Vascular Scaffold vs. Everolimus-Eluting Metallic Stent\u3000', 'XIENCE metallic DES', 'Absorb BVS']","['rates of device-oriented events', 'DMR (death, myocardial infarction [MI], and all revascularization), target vessel failure (TVF), major adverse cardiac events (MACE), target lesion failure (TLF), and cardiac death/all MI', 'death, MI, coronary revascularization, and scaffold/stent thrombosis', 'scaffold/stent thrombosis', 'Absorb BVS', 'TVF, MACE, and all MI rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",400.0,0.0925617,There were no significant differences in the composite or individual endpoint outcomes between the Absorb and XIENCE arms through 5 years or between 3 and 5 years.,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Department of Cardiology, Teikyo University.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Department of Cardiology, Mitsui Memorial Hospital.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Hamazaki', 'Affiliation': 'Division of Cardiology, Ootakanomori Hospital.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Ando', 'Affiliation': 'Department of Cardiovascular Medicine, The University of Tokyo Hospital.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University Hospital.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Cardiovascular Medicine, Shiga University of Medical Science.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kusano', 'Affiliation': 'Abbott Vascular.'}, {'ForeName': 'Divine', 'Initials': 'D', 'LastName': 'Ediebah', 'Affiliation': 'Abbott Vascular.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Department of Cardiovascular Medicine/Graduate School of Medicine, Kyoto University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-1184']
68,32327729,Deepening responses associated with improved progression-free survival with ixazomib versus placebo as posttransplant maintenance in multiple myeloma.,"In the TOURMALINE-MM3 study, post-autologous stem cell transplantation maintenance therapy with the oral proteasome inhibitor ixazomib versus placebo significantly improved progression-free survival (PFS), with a favorable safety profile. With ixazomib versus placebo maintenance, deepening responses occurred in 139/302 (46%) versus 60/187 (32%) patients with very good partial response or partial response (VGPR/PR) at study entry (relative risk 1.41, P = 0.004), and median time to best confirmed deepened response was 19.9 versus 30.8 months (24-month rate: 54.2 versus 41.4%; hazard ratio (HR): 1.384; P = 0.0342). Median PFS in patients with VGPR/PR at study entry was 26.2 versus 18.5 months (HR: 0.636, P < 0.001) with ixazomib versus placebo; in a pooled analysis across arms, in patients with versus without deepening responses, the median PFS was not reached versus 15.9 months (HR: 0.245, P < 0.001). In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028). These analyses demonstrate the significantly higher rate of deepening responses with ixazomib versus placebo maintenance and the association between deepening response and prolonged PFS.",2020,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).",[],"['placebo', 'ixazomib versus placebo', 'ixazomib']","['partial response or partial response (VGPR/PR', 'progression-free survival (PFS', '24-month PFS rate', 'median PFS', 'Median PFS', 'progression-free survival']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273711', 'cui_str': 'ixazomib'}]","[{'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C3641222', 'cui_str': 'Very good'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.0931225,"In patients with deepening responses, 24-month PFS rate was 77.4 versus 68.3% with ixazomib versus placebo (HR: 0.831; P = 0.466); in patients without deepening responses, median PFS was 17.9 versus 14.1 months (HR: 0.741; P = 0.028).","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Internal Medicine V and National Center for Tumor Diseases (NCT), University Clinic Heidelberg, Heidelberg, Germany. Hartmut.Goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology & Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}, {'ForeName': 'Wee-Joo', 'Initials': 'WJ', 'LastName': 'Chng', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Mikala', 'Affiliation': 'South Pest Central Hospital, National Institute for Hematology and Infectious Diseases, Budapest, Hungary.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford University Hospitals, NHS Foundation Trust, Oxford Myeloma Centre for Translational Research, Oxford, UK.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Maria Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Hematology, Hospital Universitario de Salamanca, University Hospital of Salamanca, IBSAL, CIC, IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Leukemia,['10.1038/s41375-020-0819-8']
69,32334527,Cardiopulmonary exercise capacity and quality of life of patients with heart failure undergoing a functional training program: study protocol for a randomized clinical trial.,"BACKGROUND
Exercise intolerance is a common finding in heart failure that generates a vicious cycle in which the individual starts to limit his activities even more due to progressive fatigue. Regular physical exercise can increase the cardiopulmonary exercise capacity of these individuals. A new approach to physical exercise, known as functional training, could improve the oxygen consumption and quality of life of patients with heart failure; however, there is no information about the effect of this modality of exercise in this patient population. This randomized trial will compare the effects of 36 sessions of functional training versus strength training in heart failure patients.
METHODS
This randomized parallel-design examiner-blinded clinical trial includes individuals of both sexes aged ≥40 years receiving regular follow-up at a single academic hospital. Subjects will be randomly allocated to an intervention group (for 12-week functional training) or an active comparator group (for 12-week strength training). The primary outcomes will be the difference from baseline to the 3-month time point in peak oxygen consumption on cardiopulmonary exercise testing and quality of life assessed by the Minnesota Living with Heart Failure Questionnaire. Secondary outcome measures will include functionality assessed by the Duke Activity Status Index and gait speed test; peripheral and inspiratory muscular strength, assessed by hand grip and manovacuometry testing, respectively; endothelial function by brachial artery flow-mediated dilation; lean body mass by arm muscle circumference; and participant adherence to the exercise programs classified as a percentage of the prescribed exercise dose.
DISCUSSION
The functional training program aims to improve the functional capacity of the individual using exercises that relate to his specific physical activity transferring gains effectively to one's daily life. In this context, we believe that that functional training can increase the cardiopulmonary exercise capacity and quality of life of patients with heart failure. The trial has been recruiting patients since October 2017.
TRIAL REGISTRATION
NCT03321682. Registered on October 26, 2017.",2020,"A new approach to physical exercise, known as functional training, could improve the oxygen consumption and quality of life of patients with heart failure; however, there is no information about the effect of this modality of exercise in this patient population.","['individuals of both sexes aged ≥40\u2009years receiving regular follow-up at a single academic hospital', 'patients with heart failure', 'patients with heart failure undergoing a functional training program', 'heart failure patients']","['Regular physical exercise', 'functional training', 'functional training versus strength training', 'intervention group (for 12-week functional training) or an active comparator group (for 12-week strength training']","['cardiopulmonary exercise capacity', 'Cardiopulmonary exercise capacity and quality of life', '3-month time point in peak oxygen consumption on cardiopulmonary exercise testing and quality of life\xa0assessed by the Minnesota Living with Heart Failure Questionnaire', 'cardiopulmonary exercise capacity and quality of life', 'oxygen consumption and quality of life', 'functionality assessed by the Duke Activity Status Index and gait speed test; peripheral and inspiratory muscular strength, assessed by hand grip and manovacuometry testing, respectively; endothelial function by brachial artery flow-mediated dilation; lean body mass by arm muscle circumference; and participant adherence to the exercise programs classified as a percentage of the prescribed exercise dose']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0556969', 'cui_str': 'times/month'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.0495326,"A new approach to physical exercise, known as functional training, could improve the oxygen consumption and quality of life of patients with heart failure; however, there is no information about the effect of this modality of exercise in this patient population.","[{'ForeName': 'Daniela Meirelles', 'Initials': 'DM', 'LastName': 'do Nascimento', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil. dmnascimento@hcpa.edu.br.'}, {'ForeName': 'Karina Costa', 'Initials': 'KC', 'LastName': 'Machado', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Patrícia Martins', 'Initials': 'PM', 'LastName': 'Bock', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Marco Aurélio Lumertz', 'Initials': 'MAL', 'LastName': 'Saffi', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Livia Adams', 'Initials': 'LA', 'LastName': 'Goldraich', 'Affiliation': 'London Health Sciences Center and Western University, London, Canada.'}, {'ForeName': 'Anderson Donelli', 'Initials': 'AD', 'LastName': 'Silveira', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Clausell', 'Affiliation': 'Medical School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Beatriz D', 'Initials': 'BD', 'LastName': 'Schaan', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01481-6']
70,32389050,Necessity of Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation for Supination-External Rotation Lateral Malleolar Fractures.,"BACKGROUND
Interfragmentary lag screws, protected by a plate, have been applied for many years in the treatment of supination-external rotation (SER) ankle fractures. Recently, similar biomechanical stability was found between fixation completed with a plate and lag screw and a plate alone. The aim of this study was to determine whether interfragmentary lag screws are necessary during precontoured lateral locking plate fixation for SER lateral malleolar fractures.
METHODS
A prospective randomized controlled trial of 76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures was conducted. The patients were randomly treated either with or without the use of interfragmentary lag screws with precontoured lateral locking plate fixation. Clinical outcomes were assessed using the Olerud-Molander Ankle Score and a visual analog scale for pain. Radiologic outcomes were assessed based on the Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing. Sixty-nine patients completed 12 months of follow-up.
RESULTS
There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery. All patients in both groups achieved primary bone healing.
CONCLUSION
The results of this study suggest that with precontoured lateral locking plate fixation, the use of interfragmentary lag screw is not essential in the treatment SER lateral malleolar fractures.
LEVEL OF EVIDENCE
Level I, prospective randomized study.",2020,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"['76 patients with unilateral Lauge-Hansen SER lateral malleolar fractures', 'Sixty-nine patients completed 12 months of follow-up', 'Supination-External Rotation Lateral Malleolar Fractures']","['precontoured lateral locking plate fixation', 'Interfragmentary Lag Screws in Precontoured Lateral Locking Plate Fixation', 'interfragmentary lag screws with precontoured lateral locking plate fixation']","['Radiologic outcomes', 'biomechanical stability', 'Olerud-Molander Ankle Score and a visual analog scale for pain', 'Kellgren and Lawrence scale score, incongruity of the ankle joint, and type of fracture healing', 'primary bone healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023343', 'cui_str': 'Leprosy'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1096630', 'cui_str': 'Malleolar fracture'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}]",76.0,0.0331161,There was no significant difference between the 2 groups with regard to clinical outcomes at 3 and 12 months after surgery and radiologic outcomes at 12 months after surgery.,"[{'ForeName': 'Young Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Woo', 'Initials': 'HW', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Gi Won', 'Initials': 'GW', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Ansan Hospital, Seoul, Korea.'}, {'ForeName': 'Hak Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopaedic Surgery, Korea University Guro Hospital, Seoul, Korea.'}]",Foot & ankle international,['10.1177/1071100720917645']
71,32227602,Two-Hour CGRP Infusion Causes Gastrointestinal Hyperactivity: Possible Relevance for CGRP Antibody Treatment.,"OBJECTIVE
The monoclonal antibodies against calcitonin gene-related peptide (CGRP) or its receptor are new antimigraine drugs from which many patients already benefit. Very few side effects have been reported from the antibody trials, including very few gastrointestinal (GI) side effects. The current data derive from a double-blind cross-over study of CGRP infusion for 2 hours. We present the GI side effects of the infusion and raise the question if underreporting of GI symptoms in CGRP antibody trials has occurred. We also discuss why constipation may be more likely with CGRP receptor blockade than with CGRP neutralizing antibodies.
METHODS
Thirty healthy volunteers were recruited to receive a 2-hour infusion of CGRP 1.5 µg/minutes on 2 different days. The participants were pretreated with sumatriptan tablets (2 × 50 mg) 1 day and with placebo the other day. During the infusion, the participants were asked about side effects including a detailed description about their GI symptoms. Clinical observations like flatulence, rumbling, and use of bedpan were also noted. After the infusion, the participants filled out a questionnaire about side effects at home until 12-hour after the infusion start. The study was conducted at the Danish Headache Center at Rigshospitalet Glostrup in the period February 2018 to July 2018.
RESULTS
On both study days 93% (27/29 participants) experienced symptoms from the GI system during the infusion. Rumbling, stomach pain, nausea, diarrhea, and an urge to defecate were the most commonly experienced GI side effects. There was no difference in symptoms between placebo and sumatriptan pretreatment.
CONCLUSION
We conclude that a 2-hour infusion of CGRP causes frequent and sometimes severe symptoms from the GI system. The symptoms are not antagonized by sumatriptan. More attention should be paid to constipation as a possible side effect of CGRP receptor antagonists.",2020,"There was no difference in symptoms between placebo and sumatriptan pretreatment.
","['Causes Gastrointestinal Hyperactivity', 'Danish Headache Center at Rigshospitalet Glostrup in the period February 2018 to July 2018', 'Thirty healthy volunteers']","['CGRP', 'placebo', 'CGRP Infusion', 'sumatriptan tablets']","['Rumbling, stomach pain, nausea, diarrhea, and an urge to defecate', 'symptoms']","[{'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0221512', 'cui_str': 'Stomach ache (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.19649,"There was no difference in symptoms between placebo and sumatriptan pretreatment.
","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helene Rønde', 'Initials': 'HR', 'LastName': 'Bjerg', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}]",Headache,['10.1111/head.13795']
72,32331754,The Titeer game as an effort to prevent teen pregnancy.,"OBJECTIVE
This study is aimed to analyze the effectiveness of Titeer game toward preventing of teenage pregnancy.
METHOD
A quasi experiment with pre-posttest control group was used in this study. One hundreed and thirty eight of tenagers aged 2-10 years were recruited as participants (69 of tenagers each group). Titeer game was given to intervention group during a month. Conventional intervention (leaflet) were provided to control group. The illustrative questionnaires were measured before intervention, 2 and 10 weeks after intervention to measure knowledge, attitude, sefl-eficacy, life skill, peer influenced, behavior, and prevent of pregnancy of tenagers. Independent T-Test and General Linear Model Repeated Measured (GLM-RM) was used to complete of analysis.
RESULTS
Knowledge, attitude, self efficacy, life skill peer influenced, and pregnancy prevention were significantly increase 2 and 10 of weeks after intervention.
CONCLUSION
The Titeer game could be increase of preventing tenagers' pregnancy aged 2-10 years.",2020,"RESULTS
Knowledge, attitude, self efficacy, life skill peer influenced, and pregnancy prevention were significantly increase 2 and 10 of weeks after intervention.
",['One hundreed and thirty eight of tenagers aged 2-10 years were recruited as participants (69 of tenagers each group'],['Conventional intervention (leaflet'],"['knowledge, attitude, sefl-eficacy, life skill, peer influenced, behavior, and prevent of pregnancy of tenagers', 'illustrative questionnaires', 'Knowledge, attitude, self efficacy, life skill peer influenced, and pregnancy prevention']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0683549', 'cui_str': 'Peer Influence'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1998750', 'cui_str': 'Prevention of unwanted pregnancy'}]",,0.0244939,"RESULTS
Knowledge, attitude, self efficacy, life skill peer influenced, and pregnancy prevention were significantly increase 2 and 10 of weeks after intervention.
","[{'ForeName': '', 'Initials': '', 'LastName': 'Deswinda', 'Affiliation': 'Payung Negeri Institute of Health Science, Pekanbaru, Indonesia. Electronic address: deswinda@payungnegeri.ac.id.'}, {'ForeName': 'Rizanda', 'Initials': 'R', 'LastName': 'Machmud', 'Affiliation': 'Faculty of Medicine of Andalas University, Padang, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Yusrawati', 'Affiliation': 'Faculty of Medicine of Andalas University, Padang, Indonesia.'}, {'ForeName': 'Ahmad Syafruddin', 'Initials': 'AS', 'LastName': 'Indrapriyatna', 'Affiliation': 'Faculty of Engineering and Informatics, Andalas University, Padang, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.01.005']
73,32331728,The effect of educational intervention on enhancing the empathy among nursing students.,"With the revision on the concept of empathy, this study attempted to teach empathy to nursing students with the goal of to increase the students' empathy levels.
METHOD
We conducted a quasi-experimental study with a non-equivalent group design and incorporated empathy training, pre- and post-training empathy measurements of participants in a private nursing college (N=64). Empathy scores were measured using the Jefferson Scale of Physician Empathy (2001) and the educational intervention used was Wlodkowski and Ginsberg's Motivational Framework for Culturally Responsive Teaching (1995). Descriptive analysis and paired T-test were used to determine the effect of intervention applied.
RESULTS
The study found increased mean score for both control and experimental group during post-intervention as compared to pre-intervention mean score.
CONCLUSIONS
The result indicates the effectiveness of educational intervention in enhancing empathy among nursing students in the experimental group.",2020,"The study found increased mean score for both control and experimental group during post-intervention as compared to pre-intervention mean score.
","['participants in a private nursing college (N=64', 'nursing students']","['empathy training, pre- and post-training empathy measurements of', 'educational intervention']","['mean score', 'Empathy scores']","[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",,0.013563,"The study found increased mean score for both control and experimental group during post-intervention as compared to pre-intervention mean score.
","[{'ForeName': 'Aini', 'Initials': 'A', 'LastName': 'Ahmad', 'Affiliation': 'School of Nursing, KPJ Healthcare University College, Negeri Sembilan, Malaysia. Electronic address: ainiadelia@gmail.com.'}, {'ForeName': 'Halimah', 'Initials': 'H', 'LastName': 'Wahab', 'Affiliation': 'School of Nursing, International Medical College, Melaka, Malaysia.'}, {'ForeName': 'Nordianna', 'Initials': 'N', 'LastName': 'Seman', 'Affiliation': 'College of Nursing, Ministry of Health, Penang, Malaysia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.038']
74,32331731,The effect of communication family patterns on prevention effort HIV/AIDS transmission.,"OBJECTIVES
The aims of this study is to determine the effect of communication patterns on HIV/AIDS prevention efforts in Badung Regency.
METHOD
The design of this study is quasi-experiment involving 30 samples selected with purposive sampling technique. The study was conducted at VCT Polyclinic in Badung Hospital. Sample divided into two groups as treatment and control. The treatment group has provided with module to be learned a month. Data was collected by likert-scale questionnaires. Data analyzed with paired t test with α=0.05.
RESULTS
The finding of the study showed that there is a significant increase in the average score of HIV/AIDS prevention efforts when comparing between pre and post intervention in the treatment group [3.42 (SD=0.317) vs 3.76 (SD=0.218), p=0.001] and control group [3.18 (SD=0.279) vs 3.22 (SD=0.281), p=0.003].
CONCLUSION
This research has found the effect of communication pattern in family on prevention efforts of transmission HIV/AIDS. Open Communication in family could prevent the transmission of HIV/AIDS to family members. This research recommended health workers to provide counseling plus module.",2020,"The finding of the study showed that there is a significant increase in the average score of HIV/AIDS prevention efforts when comparing between pre and post intervention in the treatment group [3.42 (SD=0.317) vs 3.76 (SD=0.218), p=0.001] and control group [3.18 (SD=0.279) vs 3.22 (SD=0.281), p=0.003].
",['30 samples selected with purposive sampling technique'],[],['average score of HIV/AIDS prevention efforts'],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",30.0,0.0280024,"The finding of the study showed that there is a significant increase in the average score of HIV/AIDS prevention efforts when comparing between pre and post intervention in the treatment group [3.42 (SD=0.317) vs 3.76 (SD=0.218), p=0.001] and control group [3.18 (SD=0.279) vs 3.22 (SD=0.281), p=0.003].
","[{'ForeName': 'I Ketut', 'Initials': 'IK', 'LastName': 'Suardana', 'Affiliation': 'School of Nursing, Polytechnic of Health Denpasar, Indonesia. Electronic address: suarscorpio@gmail.com.'}, {'ForeName': 'I Wayan', 'Initials': 'IW', 'LastName': 'Surasta', 'Affiliation': 'School of Nursing, Polytechnic of Health Denpasar, Indonesia.'}, {'ForeName': 'Ni Luh Putu Sri', 'Initials': 'NLPS', 'LastName': 'Erawati', 'Affiliation': 'School of Midwifery, Polytechnic of Health Denpasar, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.02.003']
75,32331734,Effectiveness of physical exercise toward decreased fatigue in cervical cancer.,"OBJECTIVE
To analyses the effectiveness of physical exercise in the treatment of chemotherapy in cervical cancer against fatigue reduction.
METHOD
This research used a quantitative method of quasi experimental research design with pre-test and post-test with control group design, sampling with total sampling method. The study sample consisted of 50 people with cervical cancer who underwent chemotherapy and experienced fatigue were grouped into 2 groups: 25 treatment groups and 25 control group respondents. The analysis used Wilcoxon and Mann Withney.
RESULTS
Statistical test was obtained p=0.000 (p<0.05) so that it can be concluded that physical exercise is effective in diminishing fatigue.
CONCLUSIONS
This study is expected to provide information for the hospital to improve overall nursing care for cervical cancer sufferers, because physical exercise decreases fatigue.",2020,"RESULTS
Statistical test was obtained p=0.000 (p<0.05) so that it can be concluded that physical exercise is effective in diminishing fatigue.
","['50 people with cervical cancer who underwent chemotherapy and experienced fatigue were grouped into 2 groups: 25 treatment groups and 25 control group respondents', 'cervical cancer sufferers', 'cervical cancer against fatigue reduction', 'cervical cancer']",['physical exercise'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],50.0,0.0150427,"RESULTS
Statistical test was obtained p=0.000 (p<0.05) so that it can be concluded that physical exercise is effective in diminishing fatigue.
","[{'ForeName': 'Fatwa', 'Initials': 'F', 'LastName': 'Imelda', 'Affiliation': 'Faculty of Nursing, Universitas Sumatera Utara, Medan, Indonesia. Electronic address: fatwaimelda05@gmail.com.'}, {'ForeName': 'Nur Afi', 'Initials': 'NA', 'LastName': 'Darti', 'Affiliation': 'Faculty of Nursing, Universitas Sumatera Utara, Medan, Indonesia.'}, {'ForeName': 'Farida Linda Sari', 'Initials': 'FLS', 'LastName': 'Siregar', 'Affiliation': 'Faculty of Nursing, Universitas Sumatera Utara, Medan, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.042']
76,32331755,The improvement of infants exclusive breastfeeding through the intervention of DC motor vibratory (DMV) to postpartum mother in USU Medan hospital.,"OBJECTIVE
To determine the effect of DMV on the success of exclusive breastfeeding.
METHOD
This research is a quasi-experimental with control group design. The sample of this study was 76 postpartum mothers each in the intervention 38 and control groups 38. The instruments used were demographic data and exclusive breastfeeding. The intervention was DMV which was carried out for postpartum mothers for 6 months. Data analysis uses independent t-test.
RESULTS
The results showed that an increase in exclusive breastfeeding for postpartum mothers through the DMV program in Medan City, p=0.03 (p<0.05) with a mean intervention of 5.55, SD 0.82 and a mean control of 5.13, SD 0.83.
CONCLUSIONS
The intervention of exclusive breastfeeding is very important to increase the amount of breastfeeding in postpartum mothers. This intervention is expected to be carried out regularly in the community.",2020,"The results showed that an increase in exclusive breastfeeding for postpartum mothers through the DMV program in Medan City, p=0.03 (p<0.05) with a mean intervention of 5.55, SD 0.82 and a mean control of 5.13, SD 0.83.
","['postpartum mothers', '76 postpartum mothers each in the intervention 38 and control groups 38']",['DMV'],['exclusive breastfeeding'],"[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",76.0,0.0212806,"The results showed that an increase in exclusive breastfeeding for postpartum mothers through the DMV program in Medan City, p=0.03 (p<0.05) with a mean intervention of 5.55, SD 0.82 and a mean control of 5.13, SD 0.83.
","[{'ForeName': 'Siti Saidah', 'Initials': 'SS', 'LastName': 'Nasution', 'Affiliation': 'Faculty of Nursing, Universitas Sumatera Utara, Indonesia. Electronic address: siti.saidah@usu.ac.id.'}, {'ForeName': 'Ellyta', 'Initials': 'E', 'LastName': 'Aizar', 'Affiliation': 'Faculty of Nursing, Universitas Sumatera Utara, Indonesia.'}, {'ForeName': 'Hariati', 'Initials': 'H', 'LastName': 'Hariati', 'Affiliation': 'Faculty of Nursing, Universitas Sumatera Utara, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.029']
77,32331735,Health science students perception on professional learning after the application of IPE.,"OBJECTIVE
To study students' perceptions based on IPE learning model in hospital.
METHOD
This study is performed using a method of quantitative which involved 20 respondents from four faculties, including faculties of medicine, pharmacy, nursing, and public health. All respondents were from the Universitas Sumatera Utara, quantitative methods were based on quasi-experimental design type nonequivalent control group design pre and post interventions. The questionnaire using interprofessional Learning Readiness Scale (RIPLS) which has been validated. The data were analyzed by t-dependent.
RESULTS
This study showed a significant increase in the perception (p<0.05) on each aspect of learning IPE (except aspects of the communication and team work with p>0.05) after this intervention.
CONCLUSION
These finding conclude that the IPE model learning can be used as a strategy to make sure all aspects of professionalism can be done in medical practice in the future.",2020,"This study showed a significant increase in the perception (p<0.05) on each aspect of learning IPE (except aspects of the communication and team work with p>0.05) after this intervention.
","['20 respondents from four faculties, including faculties of medicine, pharmacy, nursing, and public health', ""students' perceptions based on IPE learning model in hospital""]",[],[],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],20.0,0.0131225,"This study showed a significant increase in the perception (p<0.05) on each aspect of learning IPE (except aspects of the communication and team work with p>0.05) after this intervention.
","[{'ForeName': 'Arlinda Sari', 'Initials': 'AS', 'LastName': 'Wahyuni', 'Affiliation': 'Faculty of Medicine, Universitas Sumatera Utara, Indonesia. Electronic address: arlinda@usu.ac.id.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Karota', 'Affiliation': 'Faculty of Nursing, Universitas Sumatera Utara, Indonesia.'}, {'ForeName': 'Dedi', 'Initials': 'D', 'LastName': 'Ardinata', 'Affiliation': 'Faculty of Medicine, Universitas Sumatera Utara, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.043']
78,32331753,Massage with lavender aromatherapy reduced sleep disturbances on infant.,"OBJECTIVE
To determine the effectiveness of lavender aromatherapy's massage on reducing sleep disturbances in infants.
METHOD
a pre-experimental one group pre-posttest design involving thirteen infants aged 6-12 months who were selected purposively with criteria having sleep disturbances. Massage is given for 30min in three consecutive days by using two drops of oil lavender aromatherapy mixed in 50ml of oil-based. Data collection used a valid and reliable questionnaire, which is Sleep Disturbances Scale in Children (SDSC), one day before and after the intervention. Data were analyzed using the Wilcoxon Test.
RESULTS
Massage using lavender aromatherapy is effective in reducing sleep disturbances in infants especially in the dimension of starting and maintaining sleep, somnolence disorders, and interruption of wakefulness sleep transition dimension (p<0.001).
CONCLUSIONS
Massage with Lavender aromatherapy is recommended as an alternative intervention to reduced sleep disturbances on infants aged 6-12 months.",2020,"RESULTS
Massage using lavender aromatherapy is effective in reducing sleep disturbances in infants especially in the dimension of starting and maintaining sleep, somnolence disorders, and interruption of wakefulness sleep transition dimension (p<0.001).
","['thirteen infants aged 6-12 months who were selected purposively with criteria having sleep disturbances', 'infants', 'Children (SDSC']","['Massage with lavender aromatherapy', 'lavender aromatherapy', ""lavender aromatherapy's massage"", 'oil lavender aromatherapy', 'Lavender aromatherapy', 'Massage']",['sleep disturbances'],"[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C2585844', 'cui_str': 'Aromatherapy massage'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",13.0,0.0149309,"RESULTS
Massage using lavender aromatherapy is effective in reducing sleep disturbances in infants especially in the dimension of starting and maintaining sleep, somnolence disorders, and interruption of wakefulness sleep transition dimension (p<0.001).
","[{'ForeName': 'Arbianingsih', 'Initials': 'A', 'LastName': 'Arbianingsih', 'Affiliation': 'School of Nursing, Alauddin State Islamic University, Makassar, South Sulawesi, Indonesia; South Sulawesi Regional Representative Council of Indonesian National Nurses Association, Indonesia. Electronic address: arbianingsih.tiro@uin-alauddin.ac.id.'}, {'ForeName': 'A Adriana', 'Initials': 'AA', 'LastName': 'Amal', 'Affiliation': 'School of Nursing, Alauddin State Islamic University, Makassar, South Sulawesi, Indonesia.'}, {'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Hidayah', 'Affiliation': 'School of Nursing, Alauddin State Islamic University, Makassar, South Sulawesi, Indonesia.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Azhari', 'Affiliation': 'School of Nursing, Alauddin State Islamic University, Makassar, South Sulawesi, Indonesia.'}, {'ForeName': 'Takdir', 'Initials': 'T', 'LastName': 'Tahir', 'Affiliation': 'South Sulawesi Regional Representative Council of Indonesian National Nurses Association, Indonesia; School of Nursing, Universitas Hasanuddin, Makassar, South Sulawesi, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.028']
79,32332962,"Comparison of articaine, lidocaine and mepivacaine for buccal infiltration after inferior alveolar nerve block in mandibular posterior teeth with irreversible pulpitis.","Aims To compare the anaesthetic efficacy of articaine, lidocaine and mepivacaine for buccal infiltration (BI) following lidocaine inferior alveolar nerve block (IANB) in mandibular posterior teeth with irreversible pulpitis.Materials and methods Patients with irreversible pulpitis in mandibular posterior teeth and unsuccessful IANB were randomly assigned to three groups: articaine group (n = 52), lidocaine group (n = 52) and mepivacaine group (n = 52). They were instructed to rate the pain experienced at four phases (before the injection, after IANB, after BI and during endodontic access) on a Heft-Parker visual analogue scale (VAS). Success was defined as the ability to access and instrument the tooth with no pain or mild pain (VAS rating ≤54 mm) after BI.Results Multivariate logistic regression analysis showed that articaine was associated with a higher success rate compared with lidocaine (OR = 3.89, 95% CI: 1.35-11.27; P = 0.02) and mepivacaine (OR = 3.67, 95% CI: 1.24-9.75; P = 0.01), after controlling for age, gender and initial pain. VAS ratings were significantly lower in the articaine group compared with those in the lidocaine group and mepivacaine group after BI and during endodontic access (P <0.01).Conclusion Articaine as a supplemental BI following IANB is a more successful anaesthetic agent in mandibular posterior teeth with irreversible pulpitis compared with lidocaine and mepivacaine.",2020,VAS ratings were significantly lower in the articaine group compared with those in the lidocaine group and mepivacaine group after BI and during endodontic access (P <0.01).Conclusion,"['mandibular posterior teeth with irreversible pulpitis', 'Patients with irreversible pulpitis in mandibular posterior teeth and unsuccessful IANB']","['articaine', 'lidocaine inferior alveolar nerve block (IANB', 'lidocaine', 'Articaine', 'articaine, lidocaine and mepivacaine', 'mepivacaine']","['ability to access and instrument the tooth with no pain or mild pain', 'success rate', 'VAS ratings', 'anaesthetic efficacy', 'buccal infiltration (BI']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0025384', 'cui_str': 'Mepivacaine'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]",,0.129014,VAS ratings were significantly lower in the articaine group compared with those in the lidocaine group and mepivacaine group after BI and during endodontic access (P <0.01).Conclusion,"[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Stomatology, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.""}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Meng', 'Affiliation': ""Department of Stomatology, Peking University People's Hospital, No.11 Xizhimen South Street, Xicheng District, Beijing, 100044, China. mengkangpku@sina.com.""}]",British dental journal,['10.1038/s41415-020-1434-9']
80,32331756,Thought stopping as a strategy for controlling adolescent negative thoughts related to earthquakes.,"OBJECTIVE
To determine the effect of thought stopping therapy (TS) and nursing intervention (NI) for changes in the ability to control negative thoughts associated with earthquakes.
METHOD
The design of this study was used a quasi-experimental study with pretest-posttest control groups and conducted in East Java-Indonesia. 112 respondents divided into intervention and control group. Intervention group were given NI and TS and control groups were given NI only. The questionnaire used in this study was valid and reliable.
RESULT
Data analysis included univariate and bivariate. There was a significant increase in the ability of adolescents to control negative thoughts related to earthquakes in both groups (control and intervention). The score of the ability to control negative thoughts in the intervention group increased 5.72 points while the control group only gained 2.82 points.
CONCLUSION
NI and TS are recommended as effective strategy for controlling the adolescents negative thought related to earthquake.",2020,There was a significant increase in the ability of adolescents to control negative thoughts related to earthquakes in both groups (control and intervention).,"['112 respondents divided into intervention and control group', 'quasi-experimental study with pretest-posttest control groups and conducted in East Java-Indonesia']",['stopping therapy (TS) and nursing intervention (NI'],"['ability of adolescents to control negative thoughts related to earthquakes', 'score of the ability to control negative thoughts']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205803', 'cui_str': 'Java'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0013463', 'cui_str': 'Earthquake'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",112.0,0.0137254,There was a significant increase in the ability of adolescents to control negative thoughts related to earthquakes in both groups (control and intervention).,"[{'ForeName': 'Yunita Astriani', 'Initials': 'YA', 'LastName': 'Hardayati', 'Affiliation': 'Mental Health Nursing, Sint Carolus School of Health Sciences, Jakarta, Indonesia; Mental Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Mustikasari', 'Affiliation': 'Mental Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia. Electronic address: mustikasari@ui.ac.id.'}, {'ForeName': 'Ria Utami', 'Initials': 'RU', 'LastName': 'Panjaitan', 'Affiliation': 'Mental Health Nursing, Faculty of Nursing, Universitas Indonesia, Depok, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.12.030']
81,32112436,Digital Cognitive Behavioral Therapy for Insomnia in Women With Chronic Migraines.,"OBJECTIVE/BACKGROUND
Insomnia commonly co-occurs with chronic migraines (CM). Non-pharmacological treatments for insomnia in CM patients remain understudied. This is a proof-of-concept study, which aims to evaluate the feasibility, acceptability, and preliminary efficacy of a digital cognitive behavioral therapy for insomnia (dCBT-I) for individuals with CM and insomnia (CM-I) in the United States.
METHODS
We recruited 42 females with CM-I symptoms from a U.S.-based observational cohort and from the general population via advertisements. Within a multiple baseline design, participants were randomized to receive dCBT-I after 2, 4, or 6 weeks of completing baseline sleep diaries. DCBT-I was scrutinized against benchmarks for completion rates (≥90% to complete dCBT-I), acceptability (≥80% to find dCBT-I acceptable), and posttreatment changes in insomnia symptoms (≥50% indicating a clinically relevant improvement in their insomnia symptoms). As a secondary measure, we also reported percentage of individuals reverting to episodic migraines.
RESULTS
Out of 42 randomized, 35 (83.3%) completed dCBT-I within the 12 weeks provided. Of these completers, 33 (94.3%) reported being satisfied (n = 16) or very satisfied (n = 17) with treatment. Additionally, 65.7% of completers responded to treatment as per universally accepted criteria for insomnia. Lastly, 34% of completers reverted from CM to episodic migraine.
CONCLUSION
This study provides evidence for the feasibility and acceptability of dCBT-I in patients with CM-I complaints. Effects of improving insomnia and migraines were suggested. These results indicate that a randomized controlled trial is needed to determine the efficacy of dCBT-I in CM patients.",2020,"Of these completers, 33 (94.3%) reported being satisfied (n = 16) or very satisfied (n = 17) with treatment.","['Women With Chronic Migraines', 'individuals with CM and insomnia (CM-I) in the United States', '42 females with CM-I symptoms from a U.S.-based observational cohort and from the general population via advertisements', 'patients with CM-I complaints']","['digital cognitive behavioral therapy', 'Digital Cognitive Behavioral Therapy', 'dCBT']","['insomnia symptoms', 'percentage of individuals reverting to episodic migraines']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1960870', 'cui_str': 'Chronic migraine'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]",42.0,0.117769,"Of these completers, 33 (94.3%) reported being satisfied (n = 16) or very satisfied (n = 17) with treatment.","[{'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Crawford', 'Affiliation': 'School of Psychological Science and Health, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Annemarie I', 'Initials': 'AI', 'LastName': 'Luik', 'Affiliation': 'Department of Epidemiology, Erasmus MC University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep & Circadian Neuroscience Institute (SCNi), University of Oxford, Oxford, UK.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Taylor', 'Affiliation': 'The Maine Sleep Center, Chest Medicine Associates, Portland, ME, USA.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Jones', 'Affiliation': 'Psychology Department, Swansea University, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Ong', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}]",Headache,['10.1111/head.13777']
82,31822157,Effects of butylphthalide injection on treatment of transient ischemic attack as shown by diffusion-weighted magnetic resonance imaging abnormality.,"Background and Objective: Transient ischemic attack (TIA) is a serious condition that is often called a warning stroke. The risk of cerebral infarction in patients with TIA and positive DWI findings is greater than that in patients with TIA and normal DWI findings. Butylphthalide injection is a new type of brain protective drug. The study aimed to determine the efficacy and safety of butylphthalide injection for treating TIA as shown by DWI abnormality progressing to infarction. Methods: We studied 98 patients with positive DWI findings among 260 patients with TIA, and randomly divided into the experimental (treatment with butylphthalide injection) and control (treatment with aspirin) groups. The number of cerebral infarctions in the two groups was recorded on 7th, 14th, 30th and 90th day, and adverse reactions were observed. The number of cerebral infarctions was compared among the different ABCD 2 scores of patients with TIA and positive DWI findings. Results: The incidence of cerebral infarction in the experimental group was significantly lower than that in the control group ( p < .05). The incidence of cerebral infarction with an ABCD 2 score less than 3 points was significantly lower than that with an ABCD 2 score of more than 3 points ( p < .05), with less adverse reactions. Conclusion: Butylphthalide injection is helpful and safe for preventing stroke following TIA, and treating TIA with positive DWI and progression to infarction.",2020,The incidence of cerebral infarction in the experimental group was significantly lower than that in the control group ( p < .05).,['98 patients with positive DWI findings among 260 patients with TIA'],"['Butylphthalide injection', 'butylphthalide injection', 'butylphthalide injection) and control (treatment with aspirin']","['risk of cerebral infarction', 'adverse reactions', 'efficacy and safety', 'number of cerebral infarctions', 'incidence of cerebral infarction', 'Transient ischemic attack (TIA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]","[{'cui': 'C0047625', 'cui_str': '3-n-butylphthalide'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]",260.0,0.0436504,The incidence of cerebral infarction in the experimental group was significantly lower than that in the control group ( p < .05).,"[{'ForeName': 'Chenhao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, Hebei, China.'}, {'ForeName': 'Yanjing', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Department of Geriatric, The Second Hospital of Baoding City, Baoding, Hebei, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Second Neurology Department, The Second Hospital of Baoding City, Baoding, Hebei, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Second Neurology Department, The Second Hospital of Baoding City, Baoding, Hebei, China.'}, {'ForeName': 'Hongxuan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, Hebei, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, Hebei, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, Hebei, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Gu', 'Affiliation': ""Fifth Department of Internal Medicine, Baoding Children's Hospital, Baoding, Hebei, China.""}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, The Second Hospital of Baoding City, Baoding, Hebei, China.'}]",The International journal of neuroscience,['10.1080/00207454.2019.1692835']
83,31786177,Effectiveness of Tailored Dietary Counseling in Treating Malnourished Outpatients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial.,"BACKGROUND
Malnutrition in patients with chronic obstructive pulmonary disease (COPD) is common and associated with poor prognosis. Nutrition interventions are necessary, but there is a lack of evidence regarding the effectiveness of tailored nutrition advice.
OBJECTIVE
This study investigated whether tailored nutrition counseling could improve dietary intake, nutritional status, functional outcomes, and health-related quality of life (QoL) of malnourished outpatients with COPD.
DESIGN
We conducted a randomized controlled trial in which participants were randomly assigned to either the intervention group (IG) or the control group (CG).
PARTICIPANTS/SETTING
One hundred and twenty malnourished outpatients with COPD participated in the study between May and November 2017 at the National Lung Hospital, Hanoi, Vietnam.
INTERVENTION
The IG received tailored nutrition counseling once per month for 3 months based on a specifically developed written nutrition resource for COPD. The CG received the same educational resource at baseline without any discussion.
MAIN OUTCOME MEASURES
The main outcome measures were energy and protein intakes, body weight change, nutritional status (Subjective Global Assessment score), muscle strength, and QoL.
STATISTICAL ANALYSES
Differences between groups before and after the intervention were assessed using two-way repeated measures analysis of variance. Generalized estimating equation modeling was used to investigate the differences between groups over time.
RESULTS
At baseline, there were no significant differences in outcomes of interest between the two groups. After 3 months of intervention, time-intervention interactions for energy intake, protein intake, and body weight change were significant (945 kcal/day, 95% CI 792 to 1,099 kcal/day, P<0.001; 50.0 g protein/day, 95% CI 43.9 to 56.1 g protein/day, P<0.001; and 1.0 kg, 95% CI 0.5 to 1.5 kg, P<0.001, respectively). Subjective Global Assessment scores improved in the IG and worsened in the CG. Significant improvements were found in inspiratory muscle strength in the IG (5.4 cmH 2 O, 95% CI 2.3 to 8.6 cmH 2 O, P=0.001) and significant decreases in handgrip strength were found in the CG after 3 months of the intervention (1.4 kg, 95% CI 0.4 to 2.4 kg, P=0.007). There was a significant interaction effect for all QoL scores (analysis of variance two-way repeated, P≤0.003). The IG also significantly improved all QoL scores from baseline to 3 months (P<0.004).
CONCLUSIONS
Tailored nutritional counseling has the potential to improve dietary intakes, nutritional status, functional outcomes, and QoL in malnourished outpatients with COPD.",2020,Significant improvements were found in inspiratory muscle strength in the IG (,"['malnourished outpatients with COPD', 'One hundred and twenty malnourished outpatients with COPD participated in the study between May and November 2017 at the National Lung Hospital, Hanoi, Vietnam', 'patients with chronic obstructive pulmonary disease (COPD', 'Malnourished Outpatients with Chronic Obstructive Pulmonary Disease']","['intervention group (IG) or the control group (CG', 'Tailored Dietary Counseling', 'tailored nutrition counseling']","['inspiratory muscle strength', 'QoL scores', 'energy and protein intakes, body weight change, nutritional status (Subjective Global Assessment score), muscle strength, and QoL', 'handgrip strength', 'Subjective Global Assessment scores', 'dietary intakes, nutritional status, functional outcomes, and QoL', 'time-intervention interactions for energy intake, protein intake, and body weight change', 'dietary intake, nutritional status, functional outcomes, and health-related quality of life (QoL']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3714365', 'cui_str': 'Counseling about nutrition'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment (assessment scale)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0888126,Significant improvements were found in inspiratory muscle strength in the IG (,"[{'ForeName': 'Ha Thanh', 'Initials': 'HT', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Toby G', 'Initials': 'TG', 'LastName': 'Pavey', 'Affiliation': ''}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Nhung Viet', 'Initials': 'NV', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Tuong Duy', 'Initials': 'TD', 'LastName': 'Pham', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Gallegos', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.09.013']
84,31810763,Improving physicians' surgical ward round competence through simulation-based training.,"OBJECTIVE
Ward rounds are an essential part of physicians' daily routine. Existing studies suggest that their practical implementation is inconsistent. Therefore, developing interventions to train ward round competence and assessing if they are effective educational tools are crucial goals for research.
METHODS
We analysed a simulation-based tutorial dedicated to fourth-year medical students, including casework and ward round simulation. We investigated the effectiveness of this intervention regarding ward round competence through a randomized controlled trial. Performance was assessed with the modified/validated surgical ward round assessment tool by two blinded and trained raters. Supplementary, motivation during the ward round tutorial was assessed for all students at different time points.
RESULTS
Analysis of the ratings show that, in contrast to the control group (pre: 66.1 vs. post: 64.8 points, p = 0.72), the ward round competence of the intervention group (pre: 62.6 vs. post: 69.6 points, p = 0.0169) improved significantly after participating in the ward round tutorial.
CONCLUSION
The results show that our simulation-based training is an effective way to improve competence of medical students in conducting surgical ward rounds.
PRACTICE IMPLICATIONS
Participation in ward round trainings is a valuable tool to prepare students for their future professional practise.",2020,"The results show that our simulation-based training is an effective way to improve competence of medical students in conducting surgical ward rounds.
",[],[],[],[],[],[],,0.0293577,"The results show that our simulation-based training is an effective way to improve competence of medical students in conducting surgical ward rounds.
","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Grünewald', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany. Electronic address: m.gruenewald@tum.de.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Klein', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany; Department of Obstetrics and Gynecology, University Hospital rechts der Isar, Technical University of Munich, Ismaningerstrasse 22, 81675 Munich, Germany. Electronic address: evelyn.klein@tum.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, Institute of Medical Informatics, Statistics and Epidemiology, Ismaninger Str. 22, 81675 Munich, Germany. Electronic address: alexander.hapfelmeier@tum.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wuensch', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany; Clinic of Psychosomatic Medicine and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Hauptstraße 5a, 79104 Freiburg, Germany. Electronic address: alexander.wuensch@uniklinik-freiburg.de.'}, {'ForeName': 'Pascal O', 'Initials': 'PO', 'LastName': 'Berberat', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany. Electronic address: berberat@tum.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartmeier', 'Affiliation': 'Technical University of Munich, TUM School of Medicine, TUM Medical Education Center, Nigerstr. 3, 81675 Munich, Germany. Electronic address: martin.gartmeier@tum.de.'}]",Patient education and counseling,['10.1016/j.pec.2019.11.029']
85,32149469,Effects of ipragliflozin on the development and progression of kidney disease in patients with type 2 diabetes: An analysis from a multicenter prospective intervention study.,"AIMS/INTRODUCTION
Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available.
METHODS
This was an investigator-initiated multicenter prospective intervention study in which ipragliflozin (50 mg) was administered once daily, and glycemic control, estimated glomerular filtration rate (eGFR) and adverse events were evaluated until 104 weeks after starting research.
RESULTS
There were 407 patients analyzed. In the eGFR ≥90 group and eGFR ≥60 to <90 group, eGFR had significantly decreased compared with baseline at all time points from 4 to 104 weeks. There were significant increases in the eGFR ≥45 to <60 groups compared with baseline at 36 weeks (2.3 ± 1.0) and 52 weeks (2.6 ± 1.2). Comparison between the eGFR <60, urine albumin-to-creatinine ratio >300 group and the eGFR <60, urine albumin-to-creatinine ratio <300 group showed a greater reduction in eGFR in the former (-5.4 ± 2.4 vs 3.3 ± 1.1) at 12 weeks and was maintained to 104 weeks. In any group, eGFR did not significantly decrease until 104 weeks compared with 4 weeks. The urine albumin-to-creatinine ratio after 52 weeks and after 104 weeks was significantly decreased compared with baseline in the eGFR ≥90 group.
CONCLUSIONS
Ipragliflozin lowers eGFR and corrects hyperfiltration in patients with high eGFR (eGFR ≥60). In patients with low eGFR (eGFR ≥30 to <60), ipragliflozin has the possibility of increasing eGFR and exerting a renoprotective effect.",2020,"In the estimated glomerular filtration rate (eGFR) ≥ 90 group and eGFR ≥60 < 90 group, eGFR had significantly decreased compared to baseline at all time points from 4 weeks to 104 weeks.","['patients with type 2 diabetes', 'cases with high eGFR (eGFR ≥60']","['ipragliflozin', 'Ipragliflozin']","['adverse events', 'eGFR', 'UACR', 'glomerular filtration rate (eGFR', 'glomerular filtration rate (eGFR) and', 'development and progression of kidney disease', 'Urine Albumin-to-Creatinine Ratio (UACR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C3492889', 'cui_str': 'ipragliflozin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0042037'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0376979,"In the estimated glomerular filtration rate (eGFR) ≥ 90 group and eGFR ≥60 < 90 group, eGFR had significantly decreased compared to baseline at all time points from 4 weeks to 104 weeks.","[{'ForeName': 'Ikuro', 'Initials': 'I', 'LastName': 'Matsuba', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Takehiro', 'Initials': 'T', 'LastName': 'Kawata', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Kotaro', 'Initials': 'K', 'LastName': 'Iemitsu', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Asakura', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Amemiya', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Syogo', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Mizuki', 'Initials': 'M', 'LastName': 'Kaneshiro', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kanamori', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kubota', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Shinoda', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Takai', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Takuma', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takihata', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takeda', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Machimura', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Fuyuki', 'Initials': 'F', 'LastName': 'Minagawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Minami', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Mokubo', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Miyakawa', 'Affiliation': 'The Study Group of the Diabetes Committee, Kanagawa Physicians Association, Yokohama, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Terauchi', 'Affiliation': 'Department of Endocrinology and Metabolism, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13248']
86,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND
No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2.
METHODS
We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first.
RESULTS
A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events.
CONCLUSIONS
In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282']
87,32333564,"Effects of robot-assisted gait training combined with virtual reality on motor and cognitive functions in patients with multiple sclerosis: A pilot, single-blind, randomized controlled trial.","BACKGROUND
Studies on robot-assisted gait training rehabilitation in multiple sclerosis have reported positive effects on mobility and quality of life. However, their effects on cognitive functions are difficult to determine because not all trials have included cognition assessments. Virtual reality-based training provides enhanced opportunity for stimulating cognitive abilities by repetitive practice, feedback information, and motivation for endurance practice.
OBJECTIVE
To compare the effects of innovative robot-assisted gait training combined with virtual reality versus standard robot-assisted gait training on information processing speed, sustained attention, working memory, and walking endurance in patients with multiple sclerosis.
METHODS
Seventeen outpatients were randomly assigned to receive robot-assisted gait training either with or without virtual reality. The robot assisted gait training + virtual reality group underwent end-effector system training engendered by virtual reality. The standard training group underwent end-effector system training. A blinded rater evaluated patients before and after treatment and at one month follow-up. The outcome measures were the Paced Auditory Serial Addition Test, Phonemic Fluency Test, Novel Task, Digit Symbol, Multiple Sclerosis Quality of Life-54, 2-Minutes Walk Test, 10-Meter Walking Test, Berg Balance Scale, gait analysis, and stabilometric assessment.
RESULTS
Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group. Significant improvement were obtained also in executive functions (p = 0.012). Both gains were maintained at the 1-month follow-up evaluation (p = 0.012, p = 0.012) in the robot-assisted gait training + virtual reality group. Both group improved quality of life after treatment (Multiple Sclerosis Quality of Life-54: Mental Health p = 0.018, Physical Health p = 0.017).
CONCLUSIONS
Both training lead to positive influenced on executive functions. However larger positive effects on gait ability were noted after robot-assisted gait training engendered by virtual reality with multiple sclerosis. Robot-assisted gait training provides a therapeutic alternative and motivational of traditional motor rehabilitation.",2020,"RESULTS
Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group.","['patients with multiple sclerosis', 'Seventeen outpatients']","['standard training group underwent end-effector system training', 'robot-assisted gait training either with or without virtual reality', 'robot-assisted gait training combined with virtual reality', 'Virtual reality-based training', 'Robot-assisted gait training', 'innovative robot-assisted gait training combined with virtual reality versus standard robot-assisted gait training', 'robot assisted gait training + virtual reality group underwent end-effector system training engendered by virtual reality', 'robot-assisted gait training rehabilitation']","['executive functions', 'mobility and quality of life', 'motor and cognitive functions', 'Paced Auditory Serial Addition Test, Phonemic Fluency Test, Novel Task, Digit Symbol, Multiple Sclerosis Quality of Life-54, 2-Minutes Walk Test, 10-Meter Walking Test, Berg Balance Scale, gait analysis, and stabilometric assessment', '2-Minutes Walk Test', 'quality of life', 'information processing speed, sustained attention, working memory, and walking endurance', 'gait ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",17.0,0.0398956,"RESULTS
Between-group comparisons showed a significant change on the 2-Minutes Walk Test (p = 0.023) after treatment in the robot-assisted gait training + virtual reality group.","[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Munari', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fonte', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Varalta', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Battistuzzi', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cassini', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Montagnoli', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Marialuisa', 'Initials': 'M', 'LastName': 'Gandolfi', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Modenese', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Filippetti', 'Affiliation': 'Neuromotor and Cognitive Rehabilitation Research Center, Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Smania', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Picelli', 'Affiliation': 'Neurorehabilitation Unit, University Hospital of Verona, Verona, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190974']
88,31473748,Dose Response to Transnasal Pulmonary Administration of Bronchodilator Aerosols via Nasal High-Flow Therapy in Adults with Stable Chronic Obstructive Pulmonary Disease and Asthma.,"BACKGROUND
There has been increasing interest in transnasal pulmonary aerosol administration, but the dose-response relationship has not been reported.
OBJECTIVES
To determine the accumulative bronchodilator dose at which patients with stable mild-to-moderate asthma and chronic obstructive pulmonary disease (COPD) achieve similar spirometry responses before and after bronchodilator tests using albuterol via a metered dose inhaler with a valved holding chamber (MDI + VHC).
METHOD
Adult patients who met ATS/ERS criteria for bronchodilator responses in pulmonary function laboratory were recruited and consented to participate. After a washout period, patients received escalating doubling dosages (0.5, 1, 2, and 4 mg) of albuterol in a total volume of 2 mL delivered by vibrating mesh nebulizer via a nasal cannula at 37°C with a flow rate of 15-20 L/min using a Venturi air entrainment device. Spirometry was measured at baseline and after each dose. Titration was stopped when an additional forced expiratory volume in 1 second (FEV1) improvement was <5%.
RESULTS
42 patients (16 males) with stable mild-to-moderate asthma (n = 29) and COPD (n = 13) were enrolled. FEV1 increment after a cumulative dose of 1.5 mg of albuterol via nasal cannula at 15-20 L/min was similar to 4 actuations of MDI + VHC (0.34 ± 0.18 vs. 0.34 ± 0.12 L, p = 0.878). Using ATS/ERS criteria of the bronchodilator test, 33.3% (14/42) and 69% (29/42) of patients responded to 0.5 and 1.5 mg of albuterol, respectively.
CONCLUSIONS
With a nasal cannula at 15-20 L/min, transnasal pulmonary delivery of 1.5 mg albuterol resulted in similar bronchodilator response as 4 actuations of MDI + VHC.",2019,"FEV1 increment after a cumulative dose of 1.5 mg of albuterol via nasal cannula at 15-20 L/min was similar to 4 actuations of MDI + VHC (0.34 ± 0.18 vs. 0.34 ± 0.12 L, p = 0.878).","['Adults with Stable Chronic Obstructive Pulmonary Disease and Asthma', '42 patients (16 males) with stable mild-to-moderate asthma (n = 29) and COPD (n = 13) were enrolled', 'patients with stable mild-to-moderate asthma and chronic obstructive pulmonary disease (COPD', 'Adult patients who met ATS/ERS criteria for bronchodilator responses in pulmonary function laboratory were recruited and consented to participate']","['Bronchodilator Aerosols via Nasal High-Flow Therapy', 'albuterol', 'albuterol via a metered dose inhaler with a valved holding chamber (MDI + VHC']",['FEV1'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C1553387', 'cui_str': 'Hold'}]",[],42.0,0.189401,"FEV1 increment after a cumulative dose of 1.5 mg of albuterol via nasal cannula at 15-20 L/min was similar to 4 actuations of MDI + VHC (0.34 ± 0.18 vs. 0.34 ± 0.12 L, p = 0.878).","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Division of Respiratory Care, Department of Cardiopulmonary Sciences, Rush University Medical Center, Chicago, Illinois, USA, Jie_Li@rush.edu.'}, {'ForeName': 'Minghua', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': ""Division of Pulmonary Function Test Laboratory, Department of Respiratory Care, People's Hospital of the Xinjiang Autonomous Region, Urumqi, China.""}, {'ForeName': 'Maierbati', 'Initials': 'M', 'LastName': 'Hadeer', 'Affiliation': ""Division of Pulmonary Function Test Laboratory, Department of Respiratory Care, People's Hospital of the Xinjiang Autonomous Region, Urumqi, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, West China School of Medicine and West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fink', 'Affiliation': 'Division of Respiratory Care, Department of Cardiopulmonary Sciences, Rush University Medical Center, Chicago, Illinois, USA.'}]",Respiration; international review of thoracic diseases,['10.1159/000501564']
89,32312288,Association between incident delirium and 28- and 90-day mortality in critically ill adults: a secondary analysis.,"BACKGROUND
While delirium prevalence and duration are each associated with increased 30-day, 6-month, and 1-year mortality, the association between incident ICU delirium and mortality remains unclear. We evaluated the association between both incident ICU delirium and days spent with delirium in the 28 days after ICU admission and mortality within 28 and 90 days.
METHODS
Secondary cohort analysis of a randomized, double-blind, placebo-controlled trial conducted among 1495 delirium-free, critically ill adults in 14 Dutch ICUs with an expected ICU stay ≥2 days where all delirium assessments were completed. In the 28 days after ICU admission, patients were evaluated for delirium and coma 3x daily; each day was coded as a delirium day [≥1 positive Confusion Assessment Method for the ICU (CAM-ICU)], a coma day [no delirium and ≥ 1 Richmond Agitation Sedation Scale (RASS) score ≤ - 4], or neither. Four Cox-regression models were constructed for 28-day mortality and 90-day mortality; each accounted for potential confounders (i.e., age, APACHE-II score, sepsis, use of mechanical ventilation, ICU length of stay, and haloperidol dose) and: 1) delirium occurrence, 2) days spent with delirium, 3) days spent in coma, and 4) days spent with delirium and/or coma.
RESULTS
Among the 1495 patients, 28 day mortality was 17% and 90 day mortality was 21%. Neither incident delirium (28 day mortality hazard ratio [HR] = 1.02, 95%CI = 0.75-1.39; 90 day mortality HR = 1.05, 95%CI = 0.79-1.38) nor days spent with delirium (28 day mortality HR = 1.00, 95%CI = 0.95-1.05; 90 day mortality HR = 1.02, 95%CI = 0.98-1.07) were significantly associated with mortality. However, both days spent with coma (28 day mortality HR = 1.05, 95%CI = 1.02-1.08; 90 day mortality HR = 1.05, 95%CI = 1.02-1.08) and days spent with delirium or coma (28 day mortality HR = 1.03, 95%CI = 1.00-1.05; 90 day mortality HR = 1.03, 95%CI = 1.01-1.06) were significantly associated with mortality.
CONCLUSIONS
This analysis suggests neither incident delirium nor days spent with delirium are associated with short-term mortality after ICU admission.
TRIAL REGISTRATION
ClinicalTrials.gov, Identifier NCT01785290 Registered 7 February 2013.",2020,"Neither incident delirium (28 day mortality hazard ratio [HR] = 1.02, 95%CI = 0.75-1.39; 90 day mortality HR = 1.05, 95%CI = 0.79-1.38) nor days spent with delirium (28 day mortality HR = 1.00, 95%CI = 0.95-1.05; 90 day mortality HR = 1.02, 95%CI = 0.98-1.07) were significantly associated with mortality.","['1495 delirium-free, critically ill adults in 14 Dutch ICUs with an expected ICU stay ≥2\u2009days where all delirium assessments were completed', 'critically ill adults']",['placebo'],"['days spent with delirium or coma', 'mechanical ventilation, ICU length of stay, and haloperidol dose) and: 1) delirium occurrence, 2) days spent with delirium, 3) days spent in coma, and 4) days spent with delirium and/or coma', 'incident delirium', 'mortality', '28-day mortality and 90-day mortality']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.440152,"Neither incident delirium (28 day mortality hazard ratio [HR] = 1.02, 95%CI = 0.75-1.39; 90 day mortality HR = 1.05, 95%CI = 0.79-1.38) nor days spent with delirium (28 day mortality HR = 1.00, 95%CI = 0.95-1.05; 90 day mortality HR = 1.02, 95%CI = 0.98-1.07) were significantly associated with mortality.","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Duprey', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA, 02115, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': 'Department of Intensive Care, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, the Netherlands.'}, {'ForeName': 'Becky A', 'Initials': 'BA', 'LastName': 'Briesacher', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA, 02115, USA.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Saczynski', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA, 02115, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Griffith', 'Affiliation': 'Department of Health Sciences, Bouve College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA, 02115, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'Department of Pharmacy and Health Systems Sciences, Bouve College of Health Sciences, Northeastern University, 360 Huntington Ave, Boston, MA, 02115, USA. j.devlin@neu.edu.'}]","Critical care (London, England)",['10.1186/s13054-020-02879-6']
90,32313031,Resistance training preserves high-intensity interval training induced improvements in skeletal muscle capillarization of healthy old men: a randomized controlled trial.,"Skeletal muscle capillarization is a determining factor in gas and metabolite exchange, while its impairments may contribute to the development of sarcopenia. Studies on the potential of resistance training (RT) to induce angiogenesis in older muscles have been inconclusive, and effects of sequential endurance training (ET) and RT on capillarization are unknown. Healthy older men (66.5 ± 3.8 years) were engaged in either 12 weeks of habitual course observation (HC) followed by 12 weeks of RT (n = 8), or 12 weeks of high-intensity interval training (HIIT) followed by 12 weeks of RT (n = 9). At baseline, following 12 and 24 weeks, m. vastus lateralis biopsies were obtained. (Immuno-)histochemistry was used to assess indices of muscle fiber capillarization, muscle fiber morphology and succinate dehydrogenase (SDH) activity. Single periods of RT and HIIT resulted in similar improvements in capillarization and SDH activity. During RT following HIIT, improved capillarization and SDH activity, as well as muscle fiber morphology remained unchanged. The applied RT and HIIT protocols were thus similarly effective in enhancing capillarization and oxidative enzyme activity and RT effectively preserved HIIT-induced adaptations of these parameters. Hence, both, RT and HIIT, are valid training modalities for older men to improve skeletal muscle vascularization.",2020,"During RT following HIIT, improved capillarization and SDH activity, as well as muscle fiber morphology remained unchanged.","['Healthy older men (66.5\u2009±\u20093.8 years', 'older men', 'healthy old men', 'older muscles']","['Resistance training', 'habitual course observation (HC', 'resistance training (RT']","['muscle fiber capillarization, muscle fiber morphology and succinate dehydrogenase (SDH) activity', 'skeletal muscle capillarization', 'capillarization and SDH activity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0038615', 'cui_str': 'Succinate dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]",,0.02211,"During RT following HIIT, improved capillarization and SDH activity, as well as muscle fiber morphology remained unchanged.","[{'ForeName': 'Aurel B', 'Initials': 'AB', 'LastName': 'Leuchtmann', 'Affiliation': 'Institute of Translational Medicine ITM, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandro Manuel', 'Initials': 'SM', 'LastName': 'Mueller', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aguayo', 'Affiliation': 'Institute of Human Movement Sciences, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Petersen', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ligon-Auer', 'Affiliation': 'Institute of Human Movement Sciences, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Flück', 'Affiliation': 'Laboratory for Muscle Plasticity, Balgrist University Hospital, Department of Orthopaedics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Jung', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Toigo', 'Affiliation': 'Institute of Human Movement Sciences, ETH Zurich, Zurich, Switzerland. marco.toigo@oym.ch.'}]",Scientific reports,['10.1038/s41598-020-63490-x']
91,32173607,Nasal high flow improves ventilation during propofol sedation: A randomized cross-over study in healthy volunteers.,"OBJECTIVE
Hypoventilation and carbon dioxide (CO 2 ) retention are common during sedation. The current study investigated the ventilation responses to nasal high flow (NHF) during sedation with propofol.
METHODS
NHF of 30 L/min and 60 L/min with room air was applied during wakefulness and sedation in 10 male volunteers. Ventilation was monitored by respiratory inductance plethysmography, transcutaneous partial pressure of CO 2 (TcCO 2 ), and SpO 2 .
RESULTS
During sedation, NHF of 30 L/min and 60 L/min reduced the TcCO 2 by 2.9 ± 2.7 mmHg (p = 0.025) and by 3.6 ± 3.4 mmHg (p = 0.024) without affecting SpO 2 and reduced the mean respiratory rate by 3 ± 3 breaths/min (p = 0.011) and by 4 ± 3 breaths/min (p = 0.003), respectively.
CONCLUSION
During sedation with propofol, NHF without supplemental oxygen attenuated CO 2 retention and reduced the respiratory rate. The findings show that NHF can improve ventilation during sedation, which may reduce the risk of complications related to hypoventilation.",2020,"The findings show that NHF can improve ventilation during sedation, which may reduce the risk of complications related to hypoventilation.","['NHF of 30\u2009L/min and 60\u2009L/min with room air was applied during wakefulness and sedation in 10 male volunteers', 'healthy volunteers']","['propofol sedation', 'propofol, NHF without supplemental oxygen attenuated CO', 'propofol', 'NHF']","['Nasal high flow improves ventilation', 'respiratory rate', 'mean respiratory rate', 'respiratory inductance plethysmography, transcutaneous partial pressure of CO 2 (TcCO 2 ), and SpO 2 ']","[{'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}]",10.0,0.0290219,"The findings show that NHF can improve ventilation during sedation, which may reduce the risk of complications related to hypoventilation.","[{'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Sanuki', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Revie', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher & Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Division of Clinical Physiology, Department of Translational Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan; Department of Dental Anesthesiology, Nagasaki University Hospital, Nagasaki, Japan. Electronic address: ayuse@nagasaki-u.ac.jp.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103429']
92,32112730,Prelabor screening at term using the cerebroplacental ratio and placental growth factor: a pragmatic randomized open-label phase 2 trial.,"BACKGROUND AND OBJECTIVE
In some women placental function may not be adequate to meet fetal growth requirements in late pregnancy or the additional demands during labor, thus predisposing these infants to intrapartum fetal compromise and subsequent serious morbidity and mortality. The objective of this study was to determine if the introduction of a prelabor screening test at term combining the cerebroplacental ratio and maternal placental growth factor level would result in a reduction in a composite of adverse outcomes.
STUDY DESIGN
Single-site, nonblinded, randomized controlled trial conducted at a tertiary hospital in Brisbane, Australia. Eligible women were randomized to either receive the screening test performed between 37-38 weeks or routine obstetric care. Screen-positive women were offered induction of labor. The primary outcome was a composite of emergency cesarean delivery for nonreassuring fetal status (fetal distress) or severe neonatal acidosis or low Apgar score or stillbirth or neonatal death.
RESULTS
Women were recruited and randomized (n = 501) between April 2017 and January 2019. Sixty-three of 249 subjects (25.3%) in the screened group compared to 56 of 252 (22.2%) in the control group experienced the primary outcome (relative risk = 1.14 [95% confidence interval, 0.83-1.56]; P = .418). Women who screened positive were more likely to require operative delivery for fetal distress, have meconium-stained liquor, have pathologic fetal heart rate abnormalities, and have infants with lower birthweight compared to women that screened negative.
CONCLUSION
The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes. However, it did show discriminatory potential, and future research should focus on refining the thresholds used.",2020,The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes.,"['Women were recruited and randomized (n=501) between April 2017 to January 2019', 'Eligible women', 'Single-site, non-blinded, randomized controlled trial conducted at a tertiary hospital in Brisbane, Australia']","['Pre-labor screening', 'screening test performed between 37-38 weeks or routine obstetric care']","['birth weight', 'composite of: emergency cesarean for non-reassuring fetal status (fetal distress) or severe neonatal acidosis or low Apgar score or stillbirth or neonatal death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring Fetal Status'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4544436', 'cui_str': 'Neonatal acidosis'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}]",,0.166963,The introduction of this test did not result in improvements in intrapartum intervention rates or neonatal outcomes.,"[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Sherrell', 'Affiliation': 'Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Vicki L', 'Initials': 'VL', 'LastName': 'Clifton', 'Affiliation': 'Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sailesh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Mater Research Institute - University of Queensland, Brisbane, Queensland, Australia; Mater Mothers' Hospital, Brisbane, Queensland, Australia; Faculty of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: sailesh.kumar@mater.uq.edu.au.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.034']
93,31484659,"A Randomized, Placebo-Controlled, Double-Blind, Dose Escalation, Single Dose, and Steady-State Pharmacokinetic Study of 9cUAB30 in Healthy Volunteers.","9cUAB30 is a synthetic analogue of 9-cis retinoic acid with chemoprevention activity in cell lines and animal models. The purpose of this phase I placebo-controlled, double-blinded, dose escalation study of 9cUAB30 was to evaluate its safety, pharmacokinetics, and determine a dose for future phase II studies. Participants received a single dose of study drug (placebo or 9cUAB30) on day 1 followed by a 6-day drug-free period and then 28 days of continuous daily dosing starting on day 8. Fifty-three healthy volunteers were enrolled into five dose cohorts (20, 40, 80, 160, and 240 mg). Participants were randomized within each dose level to receive either 9cUAB30 ( n = 8) or placebo ( n = 2). 9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol. Treatment-emergent grade 3 hypertension occurred in 1 of 8 participants at the 20 mg dose level and in 2 of 8 at the 240 mg dose level, all considered unlikely related to study agent; no other grade 3 adverse events were observed. The AUC increased, as expected, between day 1 (single dose) and day 36 (steady state). Pharmacokinetics were linear in dose escalation through 160 mg. 9cUAB30 administered by daily oral dosing has a favorable safety and pharmacokinetic profile. On the basis of the observed safety profile and lack of linearity in pharmacokinetics at doses greater than 160 mg, the recommended phase II dose with the current formulation is 160 mg once daily.",2019,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","['Healthy Volunteers', 'Fifty-three healthy volunteers']","['placebo', 'Placebo', '9cUAB30', 'drug (placebo or 9cUAB30']","['grade 3 adverse events', 'serum triglycerides or cholesterol', 'grade 3 hypertension']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1311390', 'cui_str': '(9Z)-UAB30'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",53.0,0.180973,"9cUAB30 was well tolerated, with no dose limiting toxicities reported and no evidence of persistent elevations in serum triglycerides or cholesterol.","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Kolesar', 'Affiliation': 'College of Pharmacy, University of Kentucky, Lexington, Kentucky. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Andrews', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Green', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Tom C', 'Initials': 'TC', 'LastName': 'Havighurst', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Barbara W', 'Initials': 'BW', 'LastName': 'Wollmer', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'DeShong', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Laux', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Krontiras', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'Muccio', 'Affiliation': 'Biochemistry and Molecular Genetics, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin.'}, {'ForeName': 'Clinton J', 'Initials': 'CJ', 'LastName': 'Grubbs', 'Affiliation': 'Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'House', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Parnes', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Howard H', 'Initials': 'HH', 'LastName': 'Bailey', 'Affiliation': 'University of Wisconsin Carbone Cancer Center, Madison, Wisconsin. jill.kolesar@uky.edu hhb@medicine.wisc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0310']
94,31240513,A randomized phase 2 trial of the efficacy and safety of a novel topical povidone-iodine formulation for Cancer therapy-associated Paronychia.,"Purpose Cancer therapy-associated paronychia (CAP) is a frequent adverse event associated with cytotoxic and targeted therapies that may impact dosing of anticancer therapies and patient quality of life (QoL). There are currently no evidence-based management strategies or approved treatments for CAP. Materials and Methods This was a prospective, multicenter, randomized, double-blind, vehicle-controlled phase 2 study that evaluated the efficacy and safety of 6 to 8 weeks of 1% or 2% povidone-iodine (PVP-I) topical solution versus vehicle-control in adult patients with CAP. Patients were randomized to one of three treatment arms administered twice daily: 1% PVP-I (Cohort A), 2% PVP-I (Cohort B), or vehicle-control (Cohort C). The primary endpoint was a two-grade reduction (or reduction to grade 0 if involved nails were grade 1) on the six-point Paronychia Severity Grading (PSG) scale. Secondary endpoints included safety and the effect on QoL and microbiota. Results A total of 102 patients with cancer were randomized to the study. In Cohort A, 83 of 205 (40.5%, P = 0.6059) affected nails met the primary endpoint versus Cohort C. In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3. Conclusions Treatment with twice-daily topical 2% PVP-I was safe and resulted in improvement in CAP compared with control. Clinicaltrials.gov identifier: NCT03207906. https://clinicaltrials.gov/ct2/show/NCT03207906.",2019,"In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3.","['Cancer therapy-associated Paronychia', 'adult patients with CAP', '102 patients with cancer']","['povidone-iodine (PVP-I) topical solution', 'PVP', 'novel topical povidone-iodine formulation']","['CAP', 'two-grade reduction (or reduction to grade 0', 'safety and the effect on QoL and microbiota', 'moderately or very painful nails', 'efficacy and safety', 'six-point Paronychia Severity Grading (PSG) scale']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0991555', 'cui_str': 'Topical Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}]",102.0,0.530968,"In Cohort B, 88 of 167 (52.7%, P = 0.0063) affected nails met the primary endpoint versus 64 of 169 (37.9%) in Cohort C. Nineteen of 29 patients (65.5%) in Cohort B reported moderately or very painful nails at baseline that decreased to 15 patients (51.7%) at visit 2 and five patients (17.2%) at visit 3.","[{'ForeName': 'Kara D', 'Initials': 'KD', 'LastName': 'Capriotti', 'Affiliation': 'Veloce BioPharma LLC, Fort Lauderdale, FL, USA. kcapriotti@velocebiopharma.com.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Anadkat', 'Affiliation': 'Department of Medicine, Division of Dermatology, Washington University School of Medicine, Saint Louis, MO, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Ohio State University Dermatology, Columbus, OH, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kaffenberger', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'McLellan', 'Affiliation': 'Department of Medicine, Division of Dermatology, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Barone', 'Affiliation': 'Veloce BioPharma LLC, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Oluwaseun', 'Initials': 'O', 'LastName': 'Kukoyi', 'Affiliation': 'Department of Medicine, Dermatology Service, New York, NY, USA.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Goldfarb', 'Affiliation': 'Department of Medicine, Dermatology Service, New York, NY, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Lacouture', 'Affiliation': 'Department of Medicine, Dermatology Service, New York, NY, USA.'}]",Investigational new drugs,['10.1007/s10637-019-00825-0']
95,32323560,Lifestyle interventions reduce exercise ventilatory variability in healthy individuals: a randomized intervention study.,"Aim: Variation of exercise ventilation confers poor prognosis in heart failure. Sedentary men have higher exercise ventilatory variability than athletes. However, the impact of lifestyle intervention on exercise ventilatory variability in sedentary people is unknown and this is the aim of this study. Materials & methods: Prospective controlled single-blinded interventional study that randomly assigned healthy sedentary individuals to diet and exercise (intervention group, n = 12) or no intervention (control group, n = 12) for 12 weeks. Exercise ventilatory variability was accessed before and after intervention. Results: Despite similar values at baseline, there was a 15% reduction in respiratory rate variability (root mean square of the successive differences/n) in intervention group. Conclusion: Diet and exercise training reduced exercise ventilatory variability.",2020,"Despite similar values at baseline, there was a 15% reduction in respiratory rate variability","['healthy individuals', 'heart failure', 'Sedentary men', 'randomly assigned healthy sedentary individuals to', 'sedentary people']","['Diet and exercise training', 'diet and exercise (intervention group, n=12) or no intervention (control', 'exercise ventilation', 'Lifestyle interventions', 'lifestyle intervention']","['respiratory rate variability', 'exercise ventilatory variability', 'Exercise ventilatory variability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.040285,"Despite similar values at baseline, there was a 15% reduction in respiratory rate variability","[{'ForeName': 'Renata Rt', 'Initials': 'RR', 'LastName': 'Castro', 'Affiliation': 'Medicine School, Iguaçu University, Nova Iguaçu, Brazil.'}, {'ForeName': 'Allan Robson Kluser', 'Initials': 'ARK', 'LastName': 'Sales', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Niterói, Brazil.'}, {'ForeName': 'Antonio Cl', 'Initials': 'AC', 'LastName': 'Nóbrega', 'Affiliation': 'Department of Physiology and Pharmacology, Fluminense Federal University, Niterói, Brazil.'}]",Future cardiology,['10.2217/fca-2019-0070']
96,32233107,Patient-reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma.,"OBJECTIVE
To evaluate patient-reported outcome (PRO) data from the IMmotion150 study. The phase 2 IMmotion150 study showed improved progression-free survival with atezolizumab plus bevacizumab vs sunitinib in patients with programmed death-ligand 1 (PD-L1)+ tumours and suggested activity of atezolizumab monotherapy in previously untreated metastatic renal cell carcinoma (mRCC).
PATIENTS AND METHODS
Patients with previously untreated mRCC were randomised to atezolizumab 1200 mg intravenously (i.v.) every 3 weeks (n = 103), the atezolizumab regimen plus bevacizumab 15 mg/kg i.v. every 3 weeks (n = 101), or sunitinib 50 mg orally daily (4 weeks on, 2 weeks off; n = 101). The MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle. Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores were reported for all comers. The TTD was the first ≥2-point score increase over baseline. Absolute effect size ≥0.2 suggested a clinically important difference with checkpoint inhibitor therapy vs sunitinib.
RESULTS
Completion rates were >90% at baseline and ≥80% at most visits. Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference was observed with atezolizumab (both alone and in combination) vs sunitinib. Improved TTD (hazard ratio [HR], 95% confidence interval [CI]) was more pronounced with atezolizumab monotherapy: core symptoms, 0.39 (0.22-0.71); RCC symptoms, 0.22 (0.12-0.41); and symptom interference, 0.36 (0.22-0.58). Change from baseline by visit, evaluated by the MDASI, also showed a trend favouring atezolizumab monotherapy vs sunitinib. Small sample sizes may have limited the ability to draw definitive conclusions.
CONCLUSION
PROs suggested that atezolizumab alone or with bevacizumab maintained daily function compared with sunitinib. Notably, symptoms were least severe with atezolizumab alone vs sunitinib (IMmotion150; ClinicalTrials.gov Identifier: NCT01984242).",2020,MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle.,"['Previously Untreated Metastatic Renal Cell Carcinoma', 'patients with PD-L1+ tumours', 'Patients with previously untreated mRCC']","['bevacizumab', 'Bevacizumab Versus Sunitinib', 'Atezolizumab', 'atezolizumab alone versus sunitinib', 'atezolizumab monotherapy', 'atezolizumab plus bevacizumab', 'atezolizumab regimen plus bevacizumab', 'atezolizumab']","['progression-free survival', 'MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI', 'Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores', 'Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference', 'Completion rates']","[{'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.19299,MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle.,"[{'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'School of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Joseph', 'Affiliation': 'Mayo Clinic Hospital, Jacksonville, FL, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Georges Pompidou Hospital, Paris Descartes University, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'CHU H__pitaux de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suárez', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Elaine T', 'Initials': 'ET', 'LastName': 'Lam', 'Affiliation': 'Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Caroleen', 'Initials': 'C', 'LastName': 'Quach', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Piault-Louis', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Royal Free Hospital, Queen Mary University of London, London, UK.'}]",BJU international,['10.1111/bju.15058']
97,32329033,A Multilevel Diabetes and CVD Risk Reduction Intervention in African American Churches: Project Faith Influencing Transformation (FIT) Feasibility and Outcomes.,"Wide-reaching health promotion interventions are needed in influential, accessible community settings to address African American (AA) diabetes and CVD disparities. Most AAs are overweight/obese, which is a primary clinical risk factor for diabetes/CVD. Using a faith-community-engaged approach, this study examined feasibility and outcomes of Project Faith Influencing Transformation (FIT), a diabetes/CVD screening, prevention, and linkage to care pilot intervention to increase weight loss in AA church-populations at 8 months. Six churches were matched and randomized to multilevel FIT intervention or standard education control arms. Key multilevel religiously tailored FIT intervention components included: (a) individual self-help materials (e.g., risk checklists, pledge cards); (b) YMCA-facilitated weekly group Diabetes Prevention Program (DPP) weight loss classes; (c) church service activities (e.g., sermons, responsive readings); and (d) church-community text/voice messages to promote healthy eating and physical activity. Health screenings (e.g., weight, blood pressure, blood glucose) were held during church services to identify participants with diabetes/CVD risks and refer them to their church's DPP class and linkage to care services. Participants (N = 352 church members and community members using churches' outreach ministries) were primarily female (67%) and overweight/obese (87%). Overall, FIT intervention participants were significantly more likely to achieve a > 5 lb weight loss (OR = 1.6; CI = 1.24, 2.01) than controls. Odds of intervention FIT-DPP participants achieving a > 5 lb weight loss were 3.6 times more than controls (p < .07). Exposure to sermons, text/email messages, brochures, commitment cards, and posters was significantly related to > 5 lb. weight loss. AA churches can feasibly assist in increasing reach and impact of diabetes/CVD risk reduction interventions with intensive weight loss components among at risk AA church-populations.",2020,lb weight loss were 3.6 times more than controls (p < .07).,"['African American Churches', ""Participants (N\xa0=\u2009352 church members and community members using churches' outreach ministries) were primarily female (67%) and overweight/obese (87"", 'AA church-populations at 8\xa0months', ""participants with diabetes/CVD risks and refer them to their church's DPP class and linkage to care services"", 'Six churches']","['YMCA-facilitated weekly group Diabetes Prevention Program (DPP) weight loss classes', 'multilevel FIT intervention or standard education control arms', 'CVD Risk Reduction Intervention', 'Key multilevel religiously tailored FIT intervention components included: (a) individual self-help materials (e.g., risk checklists, pledge cards']","['Health screenings (e.g., weight, blood pressure, blood glucose', 'weight loss', 'likely to achieve a\xa0', 'lb weight loss']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}]","[{'cui': 'C0220908', 'cui_str': 'Screening procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",6.0,0.0117529,lb weight loss were 3.6 times more than controls (p < .07).,"[{'ForeName': 'Jannette', 'Initials': 'J', 'LastName': 'Berkley-Patton', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, and Psychology Department, University of Missouri-Kansas City, 2411 Holmes Street, Kansas City, MO, 64108, USA. berkleypattonj@umkc.edu.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Bowe Thompson', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Alexandria G', 'Initials': 'AG', 'LastName': 'Bauer', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, and Psychology Department, University of Missouri-Kansas City, 2411 Holmes Street, Kansas City, MO, 64108, USA.'}, {'ForeName': 'Marcie', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'The Institute for Community Research, Hartford, CT, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Kansas City; Schools of Medicine and Pharmacy, University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles & Nutrition, Children's Mercy Kansas City; Pediatrics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Jenifer E', 'Initials': 'JE', 'LastName': 'Allsworth', 'Affiliation': 'Department of Biomedical and Health Informatics, School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00740-8']
98,32323103,"Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence.","PURPOSE
AE37 and GP2 are HER2 derived peptide vaccines. AE37 primarily elicits a CD4+ response while GP2 elicits a CD8+ response against the HER2 antigen. These peptides were tested in a large randomized trial to assess their ability to prevent recurrence in HER2 expressing breast cancer patients. The primary analyses found no difference in 5-year overall disease-free survival (DFS) but possible benefit in subgroups. Here, we present the final landmark analysis.
METHODS
In this 4-arm, prospective, randomized, single-blinded, multi-center phase II trial, disease-free node positive and high-risk node negative breast cancer patients enrolled after standard of care therapy. Six monthly inoculations of vaccine (VG) vs. control (CG) were given as the primary vaccine series with 4 boosters at 6-month intervals. Demographic, safety, immunologic, and DFS data were evaluated.
RESULTS
456 patients were enrolled; 154 patients in the VG and 147 in CG for AE37, 89 patients in the VG and 91 in CG for GP2. The AE37 arm had no difference in DFS as compared to CG, but pre-specified exploratory subgroup analyses showed a trend towards benefit in advanced stage (p = 0.132, HR 0.573 CI 0.275-1.193), HER2 under-expression (p = 0.181, HR 0.756 CI 0.499-1.145), and triple-negative breast cancer (p = 0.266, HR 0.443 CI 0.114-1.717). In patients with both HER2 under-expression and advanced stage, there was significant benefit in the VG (p = 0.039, HR 0.375 CI 0.142-0.988) as compared to CG. The GP2 arm had no significant difference in DFS as compared to CG, but on subgroup analysis, HER2 positive patients had no recurrences with a trend toward improved DFS (p = 0.052) in VG as compared to CG.
CONCLUSIONS
This phase II trial reveals that AE37 and GP2 are safe and possibly associated with improved clinical outcomes of DFS in certain subgroups of breast cancer patients. With these findings, further evaluations are warranted of AE37 and GP2 vaccines given in combination and/or separately for specific subsets of breast cancer patients based on their disease biology.",2020,The primary analyses found no difference in 5-year overall disease-free survival (DFS) but possible benefit in subgroups.,"['breast cancer patients', 'high-risk node negative breast cancer patients enrolled after standard of care therapy', '456 patients were enrolled; 154 patients in the VG and 147 in CG for AE37, 89 patients in the VG and 91 in CG for GP2', 'HER2 expressing breast cancer patients', 'breast cancer patients to prevent recurrence']","['vaccine (VG) vs. control (CG', 'HER2 peptide vaccines, GP2 and AE37']","['DFS', 'Demographic, safety, immunologic, and DFS data', '5-year overall disease-free survival (DFS', 'HER2 under-expression', 'advanced stage', 'triple-negative breast cancer']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0599934', 'cui_str': 'Peptide Vaccines'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]",456.0,0.0570419,The primary analyses found no difference in 5-year overall disease-free survival (DFS) but possible benefit in subgroups.,"[{'ForeName': 'Tommy A', 'Initials': 'TA', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Ft. Sam Houston, San Antonio, TX, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mittendorf', 'Affiliation': 'Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Diane F', 'Initials': 'DF', 'LastName': 'Hale', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Ft. Sam Houston, San Antonio, TX, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Myers', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Ft. Sam Houston, San Antonio, TX, USA.'}, {'ForeName': 'Kaitlin M', 'Initials': 'KM', 'LastName': 'Peace', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Ft. Sam Houston, San Antonio, TX, USA.'}, {'ForeName': 'Doreen O', 'Initials': 'DO', 'LastName': 'Jackson', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Ft. Sam Houston, San Antonio, TX, USA.'}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Greene', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Ft. Sam Houston, San Antonio, TX, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Vreeland', 'Affiliation': 'Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'G Travis', 'Initials': 'GT', 'LastName': 'Clifton', 'Affiliation': 'Department of Surgery, Brooke Army Medical Center, Ft. Sam Houston, San Antonio, TX, USA.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Ardavanis', 'Affiliation': 'Cancer Immunology and Immunotherapy Center, St. Savas Cancer Hospital, Athens, Greece.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': 'Shumway', 'Affiliation': 'Texas Oncology PA, San Antonio, TX, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Symanowski', 'Affiliation': 'Department of Cancer Biostatistics, Levine Cancer Institute, Charlotte, NC, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Murray', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sathibalan', 'Initials': 'S', 'LastName': 'Ponniah', 'Affiliation': 'Cancer Vaccine Development Laboratory, Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Anastasopoulou', 'Affiliation': 'Cancer Immunology and Immunotherapy Center, St. Savas Cancer Hospital, Athens, Greece.'}, {'ForeName': 'N F', 'Initials': 'NF', 'LastName': 'Pistamaltzian', 'Affiliation': 'Cancer Immunology and Immunotherapy Center, St. Savas Cancer Hospital, Athens, Greece.'}, {'ForeName': 'Constantin N', 'Initials': 'CN', 'LastName': 'Baxevanis', 'Affiliation': 'Cancer Immunology and Immunotherapy Center, St. Savas Cancer Hospital, Athens, Greece.'}, {'ForeName': 'Sonia A', 'Initials': 'SA', 'LastName': 'Perez', 'Affiliation': 'Cancer Immunology and Immunotherapy Center, St. Savas Cancer Hospital, Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Papamichail', 'Affiliation': 'Cancer Immunology and Immunotherapy Center, St. Savas Cancer Hospital, Athens, Greece.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Department of Surgery, Uniformed Services Health University, Bethesda, MD, USA. gpeoples@cancerinsight.com.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05638-x']
99,32323119,Testing the cross-stressor hypothesis under real-world conditions: exercise as a moderator of the association between momentary anxiety and cardiovascular responses.,"The cross-stressor adaptation hypothesis of exercise training has not been investigated under real-life conditions. Using ecological momentary assessment, we tested whether usual exercise level moderates the relationship of self-reported anxiety to concurrent ambulatory heart rate (HR) and systolic/diastolic blood pressure (SBP/DBP). Participants (N = 832) completed 24-h ambulatory monitoring of HR/BP, using a brachial BP cuff that took readings at 28-min intervals. Anxiety levels were concurrently reported on a visual analog scale (VAS) using a Palm Pilot. Usual exercise behavior was assessed by a self-report questionnaire. Random coefficients linear regression models predicting momentary HR/BP readings from time-matched anxiety scores were estimated, yielding the average within-person effect (slope) of anxiety. The interaction of exercise level (i.e., no weekly exercise, 1-149, and ≥ 150 min/week; a between-person factor) with anxiety was added to the model in order to estimate the average anxiety slope for participants in each exercise category. The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis. In an exploratory analysis of the difference in HR/BP between occasions when anxiety was in the top versus bottom person-specific quintiles of responses, the difference in HR (but not SBP or DBP) varied significantly by exercise level (F(2,625) = 4.92, p = 0.008). Though our pre-specified analysis did not support the hypothesis, we provide some post hoc evidence supporting the cross-stressor hypothesis of exercise training for the HR response to anxiety.",2020,"The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis.",[],['exercise training'],"['visual analog scale (VAS', 'HR/BP to anxiety', 'Usual exercise behavior', '24-h ambulatory monitoring of HR/BP, using a brachial BP cuff that took readings', 'HR/BP', 'Anxiety levels', 'usual exercise level moderates the relationship of self-reported anxiety to concurrent ambulatory heart rate (HR) and systolic/diastolic blood pressure (SBP/DBP']",[],"[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0242882', 'cui_str': 'Ambulatory Monitoring'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}]",,0.0208932,"The relationship of HR/BP to anxiety did not differ significantly among exercise categories, hence not providing evidence for the cross-stressor hypothesis.","[{'ForeName': 'Ipek', 'Initials': 'I', 'LastName': 'Ensari', 'Affiliation': 'Data Science Institute, Columbia University, 475 Riverside Dr, Room 320, New York, NY, 10115, USA. ie2145@columbia.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Edmondson', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Andrea T', 'Initials': 'AT', 'LastName': 'Duran', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Diaz', 'Affiliation': 'Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center, New York, NY, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00155-0']
100,31483910,Resveratrol treatment in patients with polycystic ovary syndrome decreased pro-inflammatory and endoplasmic reticulum stress markers.,"PROBLEM
Polycystic ovary syndrome (PCOS) is associated with endoplasmic reticulum (ER) stress and pro-inflammatory condition. The aim of the present study was to evaluate the effect of resveratrol treatment on pro-inflammatory and ER stress markers in patients with PCOS.
METHOD OF STUDY
Cumulus cells were obtained from 40 patients with PCOS who were divided into two groups: placebo and resveratrol treatment (receiving 800 mg/d for 40 days) groups. Blood samples were obtained from all patients before and after the procedure to evaluate interleukin (IL)-6, IL-1β, IL-18, TNF-α, NF-κB, and C-reactive protein (CRP). Total RNA was extracted from cumulus cells, and cDNA was synthesized by reverse transcription. Expressions of five genes in ER stress response pathway (ATF4, ATF6, CHOP, GRP78, and XBP1s) were assessed with quantitative real-time PCR. Statistical analysis was performed with Student's t test.
RESULTS
After treatment with resveratrol, it was found that serum levels of IL-6, IL-1β, TNF-α, IL-18, NF-κB, and CRP decreased in the treatment group. In addition, gene expression results showed that the expression levels of ATF4 (P < .05) and ATF6 (P < .001) significantly increased in the resveratrol treatment group, while the expression levels of CHOP, GRP78, and XBP1 (P < .001 for all) significantly decreased.
CONCLUSION
Results demonstrated that resveratrol has anti-inflammatory effects through the suppression of NF-κB and NF-κB-regulated gene products. On the other hand, resveratrol can modulate ER stress in granulosa cells (GCs) by altering the expression of genes involved in unfolding protein response (UPR) process. Our findings suggest that ER stress is a potential therapeutic target for patients with PCOS.",2020,"In addition, gene expression results showed that the expression levels of ATF4 (p<0.05) and ATF6 (p<0.001) significantly increased in resveratrol treatment group, while the expression levels of CHOP, GRP78, and XBP1 (p<0.001 for all) significantly decreased.
","['Polycystic ovary syndrome (PCOS', '40 PCOS patients who were divided into two groups', 'PCOS patients', 'Patients with Polycystic Ovary Syndrome']","['placebo and resveratrol treatment', 'Resveratrol Treatment']","['serum levels of IL-6, IL-1β, TNF-α, IL-18, NF-κB, and CRP', 'expression levels of CHOP, GRP78, and XBP1', 'ER stress response pathway (ATF4, ATF6, CHOP, GRP78, and XBP1s', 'Decreased Pro-inflammatory and Endoplasmic Reticulum Stress Markers', 'Blood samples', 'interleukin (IL)- 6, IL-1β, IL-18, TNF-α, NF-κB, and C-reactive protein (CRP', 'pro-inflammatory and ER stress markers', 'expression levels of ATF4 (p<0.05) and ATF6', 'Total RNA']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C3178870', 'cui_str': 'Endoplasmic Reticulum Stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",,0.0807302,"In addition, gene expression results showed that the expression levels of ATF4 (p<0.05) and ATF6 (p<0.001) significantly increased in resveratrol treatment group, while the expression levels of CHOP, GRP78, and XBP1 (p<0.001 for all) significantly decreased.
","[{'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Brenjian', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Moini', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Yamini', 'Affiliation': ""Embryology Laboratory, Department of ART, Arash Women's Hospital, Tehran University of Medical Science, Tehran, Iran.""}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Kashani', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Faridmojtahedi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Bahramrezaie', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahshad', 'Initials': 'M', 'LastName': 'Khodarahmian', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Amidi', 'Affiliation': 'Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]","American journal of reproductive immunology (New York, N.Y. : 1989)",['10.1111/aji.13186']
101,32321955,Effect of self-assembling peptide P 11 -4 on orthodontic treatment-induced carious lesions.,"This study aimed to evaluate the effect of self-assembling peptide P 11 -4 (SAP) in the therapy of initial smooth surface caries (white spot lesions, WSL) following orthodontic multibracket treatment. Twenty-three patients (13f/10m; average age 15.4 years) with at least two teeth with WSL were recruited for the randomised controlled clinical trial with split-mouth design. In opposite to the control teeth, the test teeth were treated with SAP on Day 0. The primary endpoint was the impedance measurement of WSL using customised tray to ensure reproducibility of the measurement location. The secondary endpoint was the morphometric measurement of WSL using a semi-automated approach to determine the WSL size in mm 2 . Treatment effects were adjusted for site-specific baseline values using mixed models adapted from the cross-over design. Test WSL showed a mean baseline impedance value of 46.7, which decreased to 21.1, 18.4, and 19.7 after 45, 90, and 180 days, respectively. Control WSL showed a mean baseline value of 42.0, which decreased to 35.0, 29.5, and 33.7, respectively. The overall treatment contrast was -13.7 (95% CI: -19.6 - -7.7; p < 0.001). For the secondary endpoint, the test WSL size decreased from 8.8 at baseline to 6.5 after 180 days. The control WSL decreased from 6.8 to 5.7, respectively. The related treatment contrast was -1.0 in favour of test WSL (95% CI: -1.6 - -0.5; p = 0.004). The treatment of initial carious lesions with self-assembling peptide P 11 -4 leads to superior remineralisation of the subsurface lesions compared with the control teeth.",2020,The treatment of initial carious lesions with self-assembling peptide P 11 -4 leads to superior remineralisation of the subsurface lesions compared with the control teeth.,"['Twenty-three patients (13f/10m; average age 15.4 years) with at least two teeth with WSL', 'orthodontic treatment-induced carious lesions', 'initial smooth surface caries (white spot lesions, WSL) following orthodontic multibracket treatment']","['self-assembling peptide P 11 -4', 'self-assembling peptide P 11 -4 (SAP']","['impedance measurement of WSL using customised tray to ensure reproducibility of the measurement location', 'WSL size', 'mean baseline impedance value', 'control WSL', 'morphometric measurement of WSL']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2024965', 'cui_str': 'Caries of smooth surface of tooth'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0647980', 'cui_str': 'peptide P (properdin)'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}]","[{'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0611299,The treatment of initial carious lesions with self-assembling peptide P 11 -4 leads to superior remineralisation of the subsurface lesions compared with the control teeth.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Welk', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Restorative Dentistry, Periodontology, Endodontology, Preventive and Pediatric Dentistry, Greifswald, Germany. welk@uni-greifswald.de.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ratzmann', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Orthodontics, Greifswald, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Reich', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Restorative Dentistry, Periodontology, Endodontology, Preventive and Pediatric Dentistry, Greifswald, Germany.'}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Krey', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Orthodontics, Greifswald, Germany.'}, {'ForeName': 'Ch', 'Initials': 'C', 'LastName': 'Schwahn', 'Affiliation': 'Dental school of the University Medicine Greifswald, Department of Prosthodontics, Greifswald, Germany.'}]",Scientific reports,['10.1038/s41598-020-63633-0']
102,32322023,Quality of chest compressions during pediatric resuscitation with 15:2 and 30:2 compressions-to-ventilation ratio in a simulated scenario.,"The main objetive was to compare 30:2 and 15:2 compression-to-ventilation ratio in two simulated pediatric cardiopulmonary resuscitation (CPR) models with single rescuer. The secondary aim was to analyze the errors or omissions made during resuscitation. A prospective randomized parallel controlled study comparing 15:2 and 30:2 ratio in two manikins (child and infant) was developed. The CPR was performed by volunteers who completed an basic CPR course. Each subject did 4 CPR sessions of 3 minutes each one. Depth and rate of chest compressions (CC) during resuscitation were measured using a Zoll Z series defibrillator. Visual assessment of resuscitation was performed by an external researcher. A total of 26 volunteers performed 104 CPR sessions. Between 54-62% and 44-53% of CC were performed with an optimal rate and depth, respectively, with no significant differences. No differences were found in depth or rate of CC between 15:2 and 30:2 compression-to-ventilation ratio with both manikins. In the assessment of compliance with the ERC CPR algorithm, 69.2-80.8% of the subjects made some errors or omissions during resuscitation, the most frequent was not asking for help and not giving rescue breaths. The conclusions were that a high percentage of CC were not performed with optimal depth and rate. Errors or omissions were frequently made by rescuers during resuscitation.",2020,No differences were found in depth or rate of CC between 15:2 and 30:2 compression-to-ventilation ratio with both manikins.,['26 volunteers performed 104 CPR sessions'],['pediatric resuscitation with 15:2 and 30:2 compressions-to-ventilation ratio'],"['Quality of chest compressions', 'depth or rate of CC', 'Depth and rate of chest compressions (CC', 'Visual assessment of resuscitation']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]",26.0,0.0126162,No differences were found in depth or rate of CC between 15:2 and 30:2 compression-to-ventilation ratio with both manikins.,"[{'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Manrique', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañon University Hospital, Madrid, Spain.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'González', 'Affiliation': 'Public Health, Maternal and Child Department, School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Maitane', 'Initials': 'M', 'LastName': 'Iguiñiz', 'Affiliation': 'Public Health, Maternal and Child Department, School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Grau', 'Affiliation': 'Public Health, Maternal and Child Department, School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Toledo', 'Affiliation': 'Pediatric Department, Gregorio Marañon University Hospital, Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'García', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañon University Hospital, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Herce', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañon University Hospital, Madrid, Spain. pielvi@hotmail.com.'}]",Scientific reports,['10.1038/s41598-020-63921-9']
103,32326806,"Effects of Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter-2 Inhibitors, and Their Combination on Endothelial Glycocalyx, Arterial Function, and Myocardial Work Index in Patients With Type 2 Diabetes Mellitus After 12-Month Treatment.","Background We investigated the effects of insulin, glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT-2i), and their combination on vascular and cardiac function of patients with type 2 diabetes mellitus. Methods and Results A total of 160 patients with type 2 diabetes mellitus were randomized to insulin (n=40), liraglutide (n=40), empagliflozin (n=40), or their combination (GLP-1RA+SGLT-2i) (n=40) as add-on to metformin. We measured at baseline and 4 and 12 months posttreatment: (a) perfused boundary region of the sublingual arterial microvessels (marker of endothelial glycocalyx thickness), (b) pulse wave velocity (PWV) and central systolic blood pressure, (c) global left ventricular longitudinal, circumferential, and radial strain, (d) myocardial work index (global work index) derived by pressure-myocardial strain loops using speckle tracking imaging. Twelve months posttreatment, all patients improved perfused boundary region, PWV, global longitudinal strain, global circumferential strain, and global radial strain ( P <0.05). GLP-1RA, SGLT-2i, and their combination showed a greater reduction of perfused boundary region, PWV, and central systolic blood pressure than insulin, despite a similar glycosylated hemoglobin reduction ( P <0.05). GLP-1RA or GLP-1RA+SGLT-2i provided a greater increase of global work index (12.7% and 17.4%) compared with insulin or SGLT-2i (3.1% and 2%). SGLT-2i or GLP-1RA and SGLT-2i showed a greater decrease of PWV (10.1% and 13%) and central and brachial systolic blood pressure than insulin or GLP-1RA (PWV, 3.6% and 8.6%) ( P <0.05 for all comparisons). The dual therapy showed the greatest effect on measured markers in patients with left ventricular ejection fraction <55% ( P <0.05). Conclusions Twelve-month treatment with GLP-1RA, SGLT-2i, and their combination showed a greater improvement of vascular markers and effective cardiac work than insulin treatment in type 2 diabetes mellitus. The combined therapy as second line was superior to either insulin or GLP-1RA and SGLT-2i separately. Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT03878706.",2020,GLP-1RA or GLP-1RA+SGLT-2i provided a greater increase of global work index (12.7% and 17.4%) compared with insulin or SGLT-2i (3.1% and 2%).,"['160 patients with type 2 diabetes mellitus', 'Patients With Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus']","['liraglutide', 'Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter-2 Inhibitors', 'empagliflozin (n=40), or their combination (GLP-1RA+SGLT-2i) (n=40) as add-on to metformin', 'GLP-1RA or GLP-1RA+SGLT-2i', 'insulin, glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT-2i', 'insulin']","['PWV', 'sublingual arterial microvessels (marker of endothelial glycocalyx thickness), (b) pulse wave velocity (PWV) and central systolic blood pressure, (c) global left ventricular longitudinal, circumferential, and radial strain, (d) myocardial work index (global work index) derived by pressure-myocardial strain loops using speckle tracking imaging', 'Endothelial Glycocalyx, Arterial Function, and Myocardial Work Index', 'central and brachial systolic blood pressure', 'perfused boundary region, PWV, global longitudinal strain, global circumferential strain, and global radial strain', 'global work index', 'glycosylated hemoglobin reduction', 'vascular markers and effective cardiac work', 'perfused boundary region, PWV, and central systolic blood pressure']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1868749', 'cui_str': 'Myocardial strain'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",160.0,0.0509528,GLP-1RA or GLP-1RA+SGLT-2i provided a greater increase of global work index (12.7% and 17.4%) compared with insulin or SGLT-2i (3.1% and 2%).,"[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thymis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Dionysia', 'Initials': 'D', 'LastName': 'Birba', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Aimilianos', 'Initials': 'A', 'LastName': 'Kalogeris', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Foteini', 'Initials': 'F', 'LastName': 'Kousathana', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kountouri', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Balampanis', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology Faculty of Pharmacy National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dimitriadis', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015716']
104,32300129,Mindfulness Meditation Activates Altruism.,"Clinical evidence suggests that mindfulness meditation reduces anxiety, depression, and stress, and improves emotion regulation due to modulation of activity in neural substrates linked to the regulation of emotions and social preferences. However, less was known about whether mindfulness meditation might alter pro-social behavior. Here we examined whether mindfulness meditation activates human altruism, a component of social cooperation. Using a simple donation game, which is a real-world version of the Dictator's Game, we randomly assigned 326 subjects to a mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation. Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics. We also found a larger treatment effect of meditation among those who did not go to college (p < 0.001) and those who were under 25 years of age (p < 0.001), with both subject groups contributing virtually nothing in the control condition. Our results imply high context modularity of human altruism and the development of intervention approaches including mindfulness meditation to increase social cooperation, especially among subjects with low baseline willingness to contribute.",2020,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.",['326 subjects to a'],"['mindfulness meditation online session or control and measured their willingness to donate a portion of their payment for participation as a charitable donation', 'mindfulness meditation']","['anxiety, depression, and stress, and improves emotion regulation']","[{'cui': 'C5191353', 'cui_str': '326'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",326.0,0.0125002,"Subjects who underwent the meditation treatment donated at a 2.61 times higher rate than the control (p = 0.005), after controlling for socio-demographics.","[{'ForeName': 'Sage K', 'Initials': 'SK', 'LastName': 'Iwamoto', 'Affiliation': 'College of Letters & Sciences, UC Berkeley, Berkeley, CA, 94720, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Mindful Awareness Research Center and Cousins Center for Psychoneuroimmunology, Jane and Terry Semel Institute for Neuroscience at UCLA, and Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, CA, 90095, United States.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Christakis', 'Affiliation': 'Human Nature Lab, Yale Institute for Network Science, Yale University, New Haven, CT, 06514, United States.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nishi', 'Affiliation': 'Department of Epidemiology, UCLA Fielding School of Public Health, Los Angeles, CA, 90095, United States. akihironishi@ucla.edu.'}]",Scientific reports,['10.1038/s41598-020-62652-1']
105,32223112,Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer.,"BACKGROUND
Recent guidelines recommend consideration of the use of oral edoxaban or rivaroxaban for the treatment of venous thromboembolism in patients with cancer. However, the benefit of these oral agents is limited by the increased risk of bleeding associated with their use.
METHODS
This was a multinational, randomized, investigator-initiated, open-label, noninferiority trial with blinded central outcome adjudication. We randomly assigned consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive oral apixaban (at a dose of 10 mg twice daily for the first 7 days, followed by 5 mg twice daily) or subcutaneous dalteparin (at a dose of 200 IU per kilogram of body weight once daily for the first month, followed by 150 IU per kilogram once daily). The treatments were administered for 6 months. The primary outcome was objectively confirmed recurrent venous thromboembolism during the trial period. The principal safety outcome was major bleeding.
RESULTS
Recurrent venous thromboembolism occurred in 32 of 576 patients (5.6%) in the apixaban group and in 46 of 579 patients (7.9%) in the dalteparin group (hazard ratio, 0.63; 95% confidence interval [CI], 0.37 to 1.07; P<0.001 for noninferiority). Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
CONCLUSIONS
Oral apixaban was noninferior to subcutaneous dalteparin for the treatment of cancer-associated venous thromboembolism without an increased risk of major bleeding. (Funded by the Bristol-Myers Squibb-Pfizer Alliance; Caravaggio ClinicalTrials.gov number, NCT03045406.).",2020,"Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
","['patients with cancer', 'consecutive patients with cancer who had symptomatic or incidental acute proximal deep-vein thrombosis or pulmonary embolism to receive', 'Venous Thromboembolism Associated with Cancer']","['edoxaban or rivaroxaban', 'apixaban', 'Apixaban', 'subcutaneous dalteparin', 'dalteparin', 'oral apixaban']","['Major bleeding', 'recurrent venous thromboembolism', 'Recurrent venous thromboembolism', 'major bleeding', 'risk of major bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.301802,"Major bleeding occurred in 22 patients (3.8%) in the apixaban group and in 23 patients (4.0%) in the dalteparin group (hazard ratio, 0.82; 95% CI, 0.40 to 1.69; P = 0.60).
","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Agnelli', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Becattini', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Connors', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Bauersachs', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brenner', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Torbicki', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Maria R', 'Initials': 'MR', 'LastName': 'Sueiro', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Gualberto', 'Initials': 'G', 'LastName': 'Gussoni', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Campanini', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fontanella', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Vescovo', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Verso', 'Affiliation': ""From the Internal Vascular and Emergency Medicine-Stroke Unit, University of Perugia, Perugia (G.A., C.B., M.V.), Federazione delle Associazioni dei Dirigenti Ospedalieri Internisti (FADOI) Research Center, Milan (G.G.), the Department of Medicine, Azienda Ospedaliero-Universitaria Maggiore della Carità, Novara (M.C.), the Department of Medicine, Buon Consiglio-Fatebenefratelli Hospital, Naples (A.F.), and Internal Medicine, Azienda Ospedale-Università, Padua (G.V.) - all in Italy; Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes, Sorbonne Paris Cité, Paris, and INNOVTE, Saint-Etienne (G.M.) - both in France; Instituto de Investigatión Sanitaria Gregorio Marañon, Universidad Complûtense, Madrid (A.M.); the Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.V.H.); the Hematology Division, Brigham and Women's Hospital, and Harvard Medical School, Boston (J.M.C.); Guy's and St. Thomas' NHS Foundation Trust Hospital, King's College London, London (A.C.); the Department of Vascular Medicine, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.B.) - both in Germany; the Institute of Hematology and Bone Marrow Transplantation Unit, Rambam Health Care Campus Technion, Israel Institute of Technology, Haifa (B.B.); the Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Center for Postgraduate Medical Education, Europejskie Centrum Zdrowia, Otwock, Poland (A.T.); the Surgical Oncology Department, Institut Português de Oncologia do Porto, Porto, Portugal (M.R.S.); and Cliniques Universitaires Saint-Luc, Brussels (C.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915103']
106,32227754,Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease.,"BACKGROUND
In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status.
METHODS
We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy.
RESULTS
Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4).
CONCLUSIONS
Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","['Health Status after Invasive or Conservative Care in Coronary and Advanced Kidney Disease', 'Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease', 'participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m 2 or receipt of dialysis', 'Health status was assessed in 705 of 777 participants']",['guideline-based medical therapy alone (conservative strategy'],"['health status with the Seattle Angina Questionnaire (SAQ', 'frequent angina and better function and quality of life', 'overall trial population', 'SAQ Summary score', 'risk of death or myocardial infarction']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3811844'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",777.0,0.272639,"The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3).","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916374']
107,32227756,Management of Coronary Disease in Patients with Advanced Kidney Disease.,"BACKGROUND
Clinical trials that have assessed the effect of revascularization in patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease.
METHODS
We randomly assigned 777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy had failed. The primary outcome was a composite of death or nonfatal myocardial infarction. A key secondary outcome was a composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest.
RESULTS
At a median follow-up of 2.2 years, a primary outcome event had occurred in 123 patients in the invasive-strategy group and in 129 patients in the conservative-strategy group (estimated 3-year event rate, 36.4% vs. 36.7%; adjusted hazard ratio, 1.01; 95% confidence interval [CI], 0.79 to 1.29; P = 0.95). Results for the key secondary outcome were similar (38.5% vs. 39.7%; hazard ratio, 1.01; 95% CI, 0.79 to 1.29). The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
CONCLUSIONS
Among patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of death or nonfatal myocardial infarction. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).",2020,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","['777 patients with advanced kidney disease and moderate or severe ischemia on stress testing to be treated with an', 'patients with stable coronary disease have routinely excluded those with advanced chronic kidney disease', 'patients with stable coronary disease, advanced chronic kidney disease, and moderate or severe ischemia', 'Patients with Advanced Kidney Disease']",['initial invasive strategy consisting of coronary angiography and revascularization (if appropriate) added to medical therapy or an initial conservative strategy consisting of medical therapy alone and angiography reserved for those in whom medical therapy'],"['risk of death or nonfatal myocardial infarction', '3-year event rate', 'composite of death, nonfatal myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'composite of death or nonfatal myocardial infarction', 'death or initiation of dialysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}]",777.0,0.32092,"The invasive strategy was associated with a higher incidence of stroke than the conservative strategy (hazard ratio, 3.76; 95% CI, 1.52 to 9.32; P = 0.004) and with a higher incidence of death or initiation of dialysis (hazard ratio, 1.48; 95% CI, 1.04 to 2.11; P = 0.03).
","[{'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Evgeny I', 'Initials': 'EI', 'LastName': 'Kretov', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Briguori', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Upendra', 'Initials': 'U', 'LastName': 'Kaul', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Mazurek', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Roy O', 'Initials': 'RO', 'LastName': 'Mathew', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Radoslaw', 'Initials': 'R', 'LastName': 'Pracon', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Herzog', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the New York University Grossman School of Medicine (S. Bangalore, H.R.R., J.S.B., J.D.N., J.S.H.), Mount Sinai Hospital (G.W.S.), the Cardiovascular Research Foundation (G.W.S., Z.A.A.), and Columbia University Irving Medical Center/New York Presbyterian Hospital (Z.A.A.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (S.M.O., S. Broderick, Z.H., D.B.M., K.P.A.); the National, Heart, Lung and Blood Institute, Bethesda, MD (J.L.F.); E.N. Meshalkin National Medical Research Center, Novosibirsk (E.I.K.), and Bakulev National Medical Research Center for Cardiovascular Surgery, Moscow (O.B.) - both in Russia; Mediterranea Cardiocentro, Naples, Italy (C.B.); Batra Hospital and Medical Research Centre, New Delhi, India (U.K.); Medical University of Warsaw (T.M.) and the Department of Coronary and Structural Heart Diseases, Institute of Cardiology (R.P.) - both in Warsaw, Poland; Columbia Veterans Affairs (VA) Health Care System, Columbia, SC (R.O.M.); Hennepin Healthcare, University of Minnesota, Minneapolis (C.A.H.); VA New England Healthcare System and Boston University School of Medicine, Boston (W.E.B.); and Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.A.S.) and St. Louis University School of Medicine Center for Comprehensive Cardiovascular Care, St. Louis (B.R.C.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915925']
108,32328773,A portable survivorship care plan: a tool that helps educate and improve knowledge in childhood cancer survivors.,"PURPOSE
There is a growing population of survivors of childhood cancer at risk for late effects that can affect their overall quality of life. There is evidence that they have inadequate knowledge about their diagnosis, treatment, and subsequent late effects. A randomized study was conducted to determine if a portable credit card-sized plastic card, the ""Survivor Healthcare Passport,"" improved the survivor's knowledge of diagnosis, treatment, risks, and follow-up care. The study included 126 patients 2 years post-end of cancer treatment and took place at the UCSF Benioff Children's Hospital Survivorship Clinic.
METHODS
Patients attending the UCSF Survivorship clinic were randomized to receive or not receive a passport at their first survivorship clinic visit. Each groups' knowledge of diagnosis, treatment history, and follow-up needs was assessed at three time points with a questionnaire.
RESULTS
Patients who received the passport distributed immediately after their visit demonstrated improved and sustained knowledge compared with survivors who did not receive the passport until more than 4 months later.
CONCLUSION
Enhancing a survivor's knowledge is an important endeavor and a continual challenge for practitioners in survivorship clinics. This portable educational tool helps improve patient knowledge of their cancer, therapy, and follow-up needs. By providing a tangible card that is quick and easy to access, survivors have access to their treatment late effects and follow-up needs that can also be shared with other healthcare providers.",2021,"RESULTS
Patients who received the passport distributed immediately after their visit demonstrated improved and sustained knowledge compared with survivors who did not receive the passport until more than 4 months later.
","['Patients attending the UCSF Survivorship clinic', 'childhood cancer survivors', ""126 patients 2\xa0years post-end of cancer treatment and took place at the UCSF Benioff Children's Hospital Survivorship Clinic""]",[],['sustained knowledge'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4505050', 'cui_str': 'Survivors of Childhood Cancer'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}]",126.0,0.0292102,"RESULTS
Patients who received the passport distributed immediately after their visit demonstrated improved and sustained knowledge compared with survivors who did not receive the passport until more than 4 months later.
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Murphy', 'Affiliation': ""Pediatric Oncology, UCSF Benioff Children's Hospital, 550 16th Street, 4th Floor, San Francisco/Oakland, CA, 94158, USA. patricia.murphy@ucsf.edu.""}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': ""Pediatric Oncology, UCSF Benioff Children's Hospital, 550 16th Street, 4th Floor, San Francisco/Oakland, CA, 94158, USA.""}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Lerma', 'Affiliation': ""Pediatric Oncology, UCSF Benioff Children's Hospital, 550 16th Street, 4th Floor, San Francisco/Oakland, CA, 94158, USA.""}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': ""Pediatric Oncology, UCSF Benioff Children's Hospital, 550 16th Street, 4th Floor, San Francisco/Oakland, CA, 94158, USA.""}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': ""Pediatric Oncology, UCSF Benioff Children's Hospital, 550 16th Street, 4th Floor, San Francisco/Oakland, CA, 94158, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': ""Pediatric Oncology, UCSF Benioff Children's Hospital, 550 16th Street, 4th Floor, San Francisco/Oakland, CA, 94158, USA.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05422-z']
109,32323003,Effect of a brief physical activity-based presentation by a former patient for men treated with radical prostatectomy for prostate cancer: a mixed methods pilot study.,"PURPOSE
Existing research indicates that physical activity (PA) is beneficial to men with prostate cancer (PCa). We examined the potential of a single-contact peer-support-based behavioural intervention to promote PA engagement in men treated for PCa.
METHODS
A mixed methods design was employed, comprising a two-arm pragmatic trial and semi-structured interviews. The intervention was a 10-min PA-based presentation by a former patient, delivered in group seminars that are provided for patients as standard care. Seminars were alternately allocated to (a) cancer exercise specialist talk + patient speaker talk or (b) cancer exercise specialist talk only. Self-reported PA, exercise motivation, quality of life, fatigue and clinical and demographic characteristics were obtained from n = 148 (intervention: n = 69; control: n = 79) patients immediately prior to the seminar, and at follow-up ≈ 100 days later. Data were analysed using ANCOVA models and χ 2 tests. Fourteen semi-structured interviews with intervention participants, which explored how the intervention was experienced, were analysed using a grounded theory-style approach.
RESULTS
The intervention had no significant effect on quantitatively self-reported PA (p = 0.4). However, the intervention was statistically and clinically beneficial for fatigue (p = 0.04) and quality of life (p = 0.01). Qualitative analysis showed that the intervention was beneficial to psychological wellbeing and some participants had increased intention to engage in PA as a result of the intervention.
CONCLUSIONS
A brief one-off PA-based presentation for men with PCa, delivered by a former patient alongside cancer exercise specialist advice, may result in clinically significant benefits to quality of life and may influence PA intention in certain individuals.",2021,"However, the intervention was statistically and clinically beneficial for fatigue (p = 0.04) and quality of life (p = 0.01).","['men treated with radical prostatectomy for prostate cancer', 'men treated for PCa', 'men with PCa', 'men with prostate cancer (PCa']","['physical activity (PA', 'single-contact peer-support-based behavioural intervention', 'cancer exercise specialist talk + patient speaker talk or (b) cancer exercise specialist talk only', 'brief physical activity-based presentation', 'intervention: n\u2009=\u200969; control: n\u2009=\u200979) patients immediately prior to the seminar, and at follow-up ≈\u2009100\xa0days later']","['quality of life', 'Self-reported PA, exercise motivation, quality of life, fatigue and clinical and demographic characteristics', 'clinically beneficial for fatigue', 'intention to engage in PA']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",,0.0411093,"However, the intervention was statistically and clinically beneficial for fatigue (p = 0.04) and quality of life (p = 0.01).","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fox', 'Affiliation': ""Translational Oncology and Urology Research, King's College London, London, UK. louis.fox@kcl.ac.uk.""}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Wiseman', 'Affiliation': 'Applied Health Research, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Cahill', 'Affiliation': 'Urology Surgery, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Fleure', 'Affiliation': ""Urology Services, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Kinsella', 'Affiliation': 'Urology Surgery, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Curtis', 'Affiliation': 'Urology Surgery, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Peat', 'Affiliation': ""Physiotherapy, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""Translational Oncology and Urology Research, King's College London, London, UK.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05455-4']
110,32309882,"The effect of repetitive transcranial magnetic stimulation on food choice-related self-control in patients with severe, enduring anorexia nervosa.","OBJECTIVE
Individuals with anorexia nervosa (AN) pursue low-fat, low-calorie diets even when in a state of emaciation. These maladaptive food choices may involve fronto-limbic circuitry associated with cognitive control, habit, and reward. We assessed whether high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) influenced food-related choice behavior in patients with severe, enduring (SE)-AN.
METHOD
Thirty-four females with SE-AN completed a Food Choice Task before and after 20 sessions of real or sham rTMS treatment and at a 4-month follow-up. During the task, participants rated high- and low-fat food items for healthiness and tastiness and then made a series of choices between a neutral-rated food and high- and low-fat foods. Outcomes included the proportion of high-fat and self-controlled choices made. A comparison group of 30 healthy women completed the task at baseline only.
RESULTS
Baseline data were consistent with previous findings: relative to healthy controls, SE-AN participants showed a preference for low-fat foods and exercised self-control on a greater proportion of trials. There was no significant effect of rTMS treatment nor time on food choices related to fat content. However, among SE-AN participants who received real rTMS, there was a decrease in self-controlled food choices at post-treatment, relative to baseline. Specifically, there was an increase in the selection of tasty-unhealthy foods.
DISCUSSION
In SE-AN, rTMS may promote more flexibility in relation to food choice. This may result from neuroplastic changes in the DLPFC and/or in associated brain areas.",2020,"However, among SE-AN participants who received real rTMS, there was a decrease in self-controlled food choices at post-treatment, relative to baseline.","['30 healthy women completed the task at baseline only', 'patients with severe, enduring (SE)-AN.\nMETHOD\n\n\nThirty-four females with SE-AN completed a', 'patients with severe, enduring anorexia nervosa', 'Individuals with anorexia nervosa (AN']","['repetitive transcranial magnetic stimulation', 'high-frequency repetitive transcranial magnetic stimulation (rTMS', 'real rTMS', 'Food Choice Task before and after 20 sessions of real or sham rTMS', 'rTMS']","['self-controlled food choices', 'proportion of high-fat and self-controlled choices made']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",34.0,0.0323544,"However, among SE-AN participants who received real rTMS, there was a decrease in self-controlled food choices at post-treatment, relative to baseline.","[{'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Dalton', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Foerde', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, New York City, New York, USA.'}, {'ForeName': 'Savani', 'Initials': 'S', 'LastName': 'Bartholdy', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McClelland', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kekic', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Luiza', 'Initials': 'L', 'LastName': 'Grycuk', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Iain C', 'Initials': 'IC', 'LastName': 'Campbell', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schmidt', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Steinglass', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, New York City, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23267']
111,32320457,Sexual network distribution of HIV self-testing kits: Findings from the process evaluation of an intervention for men who have sex with men in China.,"BACKGROUND
The World Health Organization has recommended HIV self-testing (HIVST) as an alternative testing strategy given the limitations of facility-based testing. While the benefits of HIV self-testing have been demonstrated at the individual level among men who have sex with men (MSM), limited data exist on if this testing approach can be effectively diffused through individuals' social or sexual networks. The objectives of this study were to examine patterns and correlates of HIVST distribution within Chinese MSM's sexual networks.
METHODS
Data used for this analysis was a part of the process evaluation of an HIVST intervention trial among MSM in Nanjing, China. Between May and October 2017, we enrolled 400 men into the trial. Participants assigned to the intervention group (N = 200) were given three HIVST kits at baseline and could request more during the follow-up periods. We incorporated measures for process evaluation in the self-administered online follow-up surveys. This analysis reported findings from the three-month follow-up survey in the intervention group. Frequencies and percentages were used to describe characteristics of participants who distributed kits to their sexual partners as well as patterns of distribution. Multivariable logistic regression was conducted to identify independent correlates of participants who distributed the kits.
RESULTS
Of the 177 participants retained (88.5%) at the three-month follow-up, 72 (40.7%) distributed one or more kits to either primary or casual partners. About half of distributors (51.4%) gave one HIVST kit to their sexual partners while 15.3% distributed 3 or more. Over half gave these kits (58.3%) to primary sexual partners while 27.8% reported giving the kits to both primary and casual partners. About half (54.2%) of distributors used the kits together with their partners. Compared to participants who had an HIV test in the past six months, those who tested over six months ago or never tested had significantly lower odds of distributing the kits (AOR = 0.484, 95% CI: 0.250-0.983, p = 0.032). Compared to those who had not used the kits themselves, participants who did had significantly higher odds of distributing the kits (AOR = 3.345, 95% CI: 1.488-7.517, p = 0.003). Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
CONCLUSION
Our study demonstrated that a sexual network-based approach to distributing HIVST among Chinese MSM is feasible and can be a promising strategy to improve the effectiveness of HIVST programs including its reach to untested men. Such approach should be complimented by intervention components that enhance HIV testing efficacy and improve experiences of HIVST.",2020,"Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
","['men who have sex with men (MSM', 'men who have sex with men in China', '400 men into the trial', 'Of the 177 participants retained (88.5%) at the three-month follow-up, 72 (40.7%) distributed one or more kits to either primary or casual partners']",['HIV self-testing kits'],['HIV testing efficacy'],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",400.0,0.0417201,"Participants who reported higher HIV testing efficacy had 2.051 fold greater odds (95% CI: 1.062-3.961, p = 0.033) of distributing the kits compared to those who had lower efficacy.
","[{'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Xuzhou Central Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Gengfeng', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Institute of Parasitic Diseases, Wuxi, Jiangsu, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Hongjing', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China.'}, {'ForeName': 'Chongyi', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, New Jersey, United States of America.'}]",PloS one,['10.1371/journal.pone.0232094']
112,31357206,Pharmacological mechanisms of interhemispheric signal propagation: a TMS-EEG study.,"Interhemispheric connections across the corpus callosum have a predominantly inhibitory effect. Previous electrophysiology studies imply that local inhibitory circuits are responsible for inducing transcallosal inhibition, likely through inhibitory GABA B -mediated neurotransmission. We investigated the neurochemical mechanisms involved in interhemispheric connectivity by measuring transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP) in the motor cortex and dorsolateral prefrontal cortex (DLPFC) with electroencephalography (EEG) recordings under the pharmacological effects of baclofen, L-DOPA, dextromethorphan, and rivastigmine. We hypothesized that for both stimulated regions, GABA B receptor agonist baclofen would decrease ISP when compared against baseline while drugs that target other neurotransmitter systems (dopaminergic, acetylcholinergic, and glutamatergic systems) would have no effect on ISP. Twelve right-handed healthy volunteers completed this study and underwent TMS across five sessions in a randomized order. In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions. There were no drug-induced changes in ISP in the DLPFC and baseline ISP did not differ across experimental sessions for both brain regions. Together, our results suggest that the inhibitory effects observed with interhemispheric signal transmission are mediated by a population of interneurons involving GABA B receptor neurotransmission. Inhibitory mechanisms of ISP may be more salient for motor-related functions in the motor cortex than for cognitive control in the DLPFC. These findings are a fundamental step in advancing our understanding of interhemispheric connectivity and may be used to identify treatments for disorders in which transcallosal transmission is dysfunctional.",2020,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.",['Twelve right-handed healthy volunteers'],"['baclofen, L-DOPA, dextromethorphan, and rivastigmine', 'TMS', 'transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP']","['ISP under baclofen', 'ISP']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}]",12.0,0.0545946,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Lioumis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Salavati', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0468-7']
113,31742823,A Multifaceted Intervention to Improve Patient Knowledge and Safe Use of Opioids: Results of the ED EMC 2 Randomized Controlled Trial.,"OBJECTIVES
Despite increased focus on opioid prescribing, little is known about the influence of prescription opioid medication information given to patients in the emergency department (ED). The study objective was to evaluate the effect of an Electronic Medication Complete Communication (EMC 2 ) Opioid Strategy on patients' safe use of opioids and knowledge about opioids.
METHODS
This was a three-arm prospective, randomized controlled pragmatic trial with randomization occurring at the physician level. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new hydrocodone-acetaminophen prescriptions received one of three care pathways: 1) usual care, 2) EMC 2 intervention, or 3) EMC 2 + short message service (SMS) text messaging. The ED EMC 2 intervention triggered two patient-facing educational tools (MedSheet, literacy-appropriate prescription wording [Take-Wait-Stop]) and three provider-facing reminders to counsel (directed to ED physician, dispensing pharmacist, follow-up physician). Patients in the EMC 2 + SMS arm additionally received one text message/day for 1 week. Follow-up at 1 to 2 weeks assessed ""demonstrated safe use"" (primary outcome). Secondary outcomes including patient knowledge and actual safe use (via medication diaries) were assessed 2 to 4 days and 1 month following enrollment.
RESULTS
Among the 652 enrolled, 343 completed follow-up (57% women; mean ± SD age = 42 ± 14.0 years). Demonstrated safe opioid use occurred more often in the EMC 2 group (adjusted odds ratio [aOR] = 2.46, 95% confidence interval [CI] = 1.19 to 5.06), but not the EMC 2 + SMS group (aOR = 1.87, 95% CI = 0.90 to 3.90) compared with usual care. Neither intervention arm improved medication safe use as measured by medication diary data. Medication knowledge, measured by a 10-point composite knowledge score, was greater in the EMC 2 + SMS group (β = 0.57, 95% CI = 0.09 to 1.06) than usual care.
CONCLUSIONS
The study found that the EMC 2 tools improved demonstrated safe dosing, but these benefits did not translate into actual use based on medication dairies. The text-messaging intervention did result in improved patient knowledge.",2019,"Medication knowledge, measured by a 10-point composite knowledge score, was greater in the EMC 2 + SMS group (β = 0.57, 95% CI = 0.09 to 1.06) than usual care.
","[""patients' safe use of opioids and knowledge about opioids"", '652 enrolled, 343 completed follow-up (57% women; mean\xa0±\xa0SD age\xa0= 42\xa0±\xa014.0\xa0years', 'Consecutive discharged patients at an urban academic ED (>88,000 visits) with new', 'patients in the emergency department (ED']","['Electronic Medication Complete Communication (EMC 2 ) Opioid Strategy', 'EMC', 'hydrocodone-acetaminophen prescriptions received one of three care pathways: 1) usual care, 2) EMC 2 intervention, or 3) EMC 2 \xa0+\xa0short message service (SMS) text messaging', 'Opioids']","['patient knowledge and actual safe use (via medication diaries', 'Medication knowledge', 'safe opioid use', 'medication safe use', 'patient knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3178909'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",652.0,0.0951602,"Medication knowledge, measured by a 10-point composite knowledge score, was greater in the EMC 2 + SMS group (β = 0.57, 95% CI = 0.09 to 1.06) than usual care.
","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'McCarthy', 'Affiliation': 'Department of Emergency Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Curtis', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}, {'ForeName': 'D Mark', 'Initials': 'DM', 'LastName': 'Courtney', 'Affiliation': 'Department of Emergency Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Lank', 'Affiliation': 'Department of Emergency Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Opsasnick', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}, {'ForeName': 'Abbie E', 'Initials': 'AE', 'LastName': 'Lyden', 'Affiliation': 'College of Pharmacy, Rosalind Franklin School of Medicine and Science, Chicago, IL.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Gravenor', 'Affiliation': 'Department of Emergency Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Russell', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}, {'ForeName': 'Morgan R', 'Initials': 'MR', 'LastName': 'Eifler', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}, {'ForeName': 'Scott I', 'Initials': 'SI', 'LastName': 'Hur', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Rowland', 'Affiliation': 'Department of Emergency Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Surrey M', 'Initials': 'SM', 'LastName': 'Walton', 'Affiliation': 'Department of Pharmacy Administration, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Enid', 'Initials': 'E', 'LastName': 'Montague', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}, {'ForeName': 'Kwang-Youn A', 'Initials': 'KA', 'LastName': 'Kim', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Chicago, IL.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13860']
114,31641214,Preoperative liking and wanting for sweet beverages as predictors of body weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy.,"BACKGROUND/OBJECTIVES
Patients who receive Roux-en-Y gastric bypass (RYGB) lose more weight than those who receive vertical sleeve gastrectomy (VSG). RYGB and VSG alter hedonic responses to sweet flavor, but whether baseline differences in hedonic responses modulate weight loss after RYGB or VSG remains untested.
PARTICIPANTS/METHODS
Male and female candidates (n = 66) for RYGB or VSG were recruited and tested for their subjective liking and wanting ratings of sucrose solutions and flavored beverages sweetened with aspartame. Participants were classified by unsupervised hierarchical clustering for their liking and wanting ratings of sucrose and aspartame. Participant liking ratings were also used in a supervised classification using pre-established categories of liking ratings (liker, disliker, and inverted u-shape). Effects of categories obtained from unsupervised or supervised classification on body weight loss and their interaction with surgery type were analyzed separately at 3 and 12 months after surgery using linear models corrected for sex and age.
RESULTS
RYGB participants lost more body weight compared with VSG participants at 3 and 12 months after surgery (P < 0.001 for both time points). Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame. RYGB participants in high-wanting clusters based on sucrose, but not aspartame, lost more weight than VSG at both 3 (P = 0.01) and 12 months (P = 0.03), yielding a significant cluster by surgery interaction. Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
CONCLUSIONS
Classification of patients into high/low-wanting ratings for sucrose before surgery can predict differential body weight loss after RYGB or VSG in adults and could be used to advise on surgery type.",2020,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","['Patients who receive', 'Male and female candidates (n\u2009=\u200966) for RYGB or VSG']","['Roux-en-Y gastric bypass and sleeve gastrectomy', 'Preoperative liking and wanting for sweet beverages', 'RYGB and VSG', 'Roux-en-Y gastric bypass (RYGB', 'vertical sleeve gastrectomy (VSG', 'sucrose solutions and flavored beverages sweetened with aspartame', 'Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame']","['Participant liking ratings', 'body weight', 'body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0158572,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants.
","[{'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Perez-Leighton', 'Affiliation': 'Department of Physiology, School of Biological Sciences, Pontificia Universidad Católica, Santiago, Chile.'}, {'ForeName': 'Jeon D', 'Initials': 'JD', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Shoran', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Albu', 'Affiliation': ""Mt. Sinai St. Luke's Hospital, New York, NY, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'NutriSci Incorporated, Mt. Kisco, NY, USA.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Kissileff', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA. Harry.Kissileff2@mountsinai.org.'}]",International journal of obesity (2005),['10.1038/s41366-019-0474-1']
115,31846631,Effects of 12-week avocado consumption on cognitive function among adults with overweight and obesity.,"OBJECTIVES
Excess adiposity increases risk for cognitive impairment. Consumption of avocado, a highly bioavailable source of the xanthophyll lutein, has been shown to improve retinal lutein accumulation and cognitive function. Thus, we evaluated the influence of avocado consumption on cognitive function and lutein status among adults with overweight and obesity using a randomized-controlled trial with matching design for pertinent study outcomes.
METHODS
A cohort of 84 adults (25-45 years, 31 males) were randomized to a treatment group (N = 47) that received a 12-week daily meal with fresh Hass avocado or a control group (N = 37) that received an isocaloric meal (clinicaltrials.gov, NCT02740439). Serum lutein and macular pigment optical density (MPOD) were used to assess xanthophyll status. Attention and inhibition were assessed using the Flanker, Oddball and Nogo tasks with accompanying electroencephalographic (EEG) recording.
RESULTS
Participants in the treatment group exhibited improvements in serum lutein and accuracy in the Flanker task. However, there were no relationships between performance and changes in lutein status, nor neuroelectric variables. No significant changes in MPOD were observed.
CONCLUSION
Daily avocado intake over 12 weeks, after controlling for covariates, improved attentional inhibition and increased serum lutein concentrations among adults with overweight and obesity. However, the cognitive benefits were independent of changes in lutein concentrations. Additional work is necessary to determine non-carotenoid, or carotenoid interactive, mechanisms by which avocados may influence cognitive function.",2020,"Daily avocado intake over 12 weeks, after controlling for covariates, improved attentional inhibition and increased serum lutein concentrations among adults with overweight and obesity.","['84 adults (25-45\u202fyears, 31 males', 'adults with overweight and obesity']","['avocado consumption', '12-week daily meal with fresh Hass avocado or a control group (N\u202f=\u202f37) that received an isocaloric meal']","['cognitive function', 'Serum lutein and macular pigment optical density (MPOD', 'cognitive function and lutein status', 'Daily avocado intake', 'attentional inhibition', 'MPOD', 'lutein status, nor neuroelectric variables', 'serum lutein concentrations', 'serum lutein and accuracy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C1268822', 'cui_str': 'Optical density (observable entity)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",84.0,0.0472716,"Daily avocado intake over 12 weeks, after controlling for covariates, improved attentional inhibition and increased serum lutein concentrations among adults with overweight and obesity.","[{'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Edwards', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Walk', 'Affiliation': 'Department of Psychology, Eastern Illinois University, United States of America.'}, {'ForeName': 'Sharon V', 'Initials': 'SV', 'LastName': 'Thompson', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, United States of America.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Reeser', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, United States of America.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Erdman', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, United States of America; Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, United States of America.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, United States of America; Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, United States of America.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Holscher', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, United States of America; Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, United States of America; Department of Food Science and Human Nutrition, University of Illinois at Urbana-Champaign, United States of America.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, United States of America; Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, United States of America. Electronic address: nakhan2@illinois.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2019.12.006']
116,31794974,One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.,"Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p < 0.05). In summary, greater accumulated exposure to active iTBS demonstrated clinically meaningful improvements in the year following stimulation, and default mode connectivity could be used to predict longer-term outcomes.",2020,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","['post-traumatic stress disorder (PTSD', 'Mean age was 51.0\u2009±\u200912.3 years and seven (15.2%) were female', 'fifty veterans with PTSD', ""Forty-six (92%) of the initial study's intent-to-treat participants were included""]","['total of 4-weeks of active iTBS', 'active iTBS (4-weeks active iTBS', 'theta burst stimulation', 'active intermittent TBS (iTBS', 'Theta burst transcranial magnetic stimulation (TBS', 'TMS']","['clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS', 'Mean days to relapse']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",50.0,0.149203,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrosino', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': ""Mascha van 't"", 'Initials': ""MV'"", 'LastName': 'Wout-Frank', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zandvakili', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA. noah_philip@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0584-4']
117,31995812,Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment.,"Major depressive disorder (MDD) is associated with altered global brain connectivity (GBC), as assessed via resting-state functional magnetic resonance imaging (rsfMRI). Previous studies found that antidepressant treatment with ketamine normalized aberrant GBC changes in the prefrontal and cingulate cortices, warranting further investigations of GBC as a putative imaging marker. These results were obtained via global signal regression (GSR). This study is an independent replication of that analysis using a separate dataset. GBC was analyzed in 28 individuals with MDD and 22 healthy controls (HCs) at baseline, post-placebo, and post-ketamine. To investigate the effects of preprocessing, three distinct pipelines were used: (1) regression of white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF + GSR (GSR); and (3) WM/CSF + physiological parameter regression (PHYSIO). Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal. Ketamine had no effect compared to baseline or placebo in either group in any pipeline. PHYSIO did not resemble GBC preprocessed with GSR. These results concur with several studies that used GSR to study GBC. Further investigations are warranted into disease-specific components of global fMRI signals that may drive these results and of GBCr as a potential imaging marker in MDD.",2020,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","['Major depressive disorder (MDD', '28 individuals with MDD and 22 healthy controls (HCs) at baseline, post']","['placebo', 'Ketamine', 'placebo-controlled ketamine', 'ketamine', 'white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF\u2009+\u2009GSR (GSR); and (3) WM/CSF\u2009+\u2009physiological parameter regression (PHYSIO']","['GBC', 'Reduced GBC']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",28.0,0.0521611,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. christoph.kraus@nih.gov.'}, {'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0624-0']
118,31995813,"Modafinil enhances cognitive, but not emotional conflict processing via enhanced inferior frontal gyrus activation and its communication with the dorsomedial prefrontal cortex.","Cognitive control regulates cognitive and emotional systems to facilitate goal-directed behavior in the context of task-irrelevant distractors. Cognitive control deficits contribute to residual functional impairments across psychiatric disorders and represent a promising novel treatment target. Translational evidence suggests that modafinil may enhance performance in executive functions; however, differential effects on regulatory control in cognitive and emotional domains have not been examined. The present pre-registered randomized-controlled pharmacological fMRI trial examined differential effects of modafinil (single-dose, 200 mg) on cognitive and emotional conflict processing. To further separate objective cognitive enhancing effects from subjective performance perception, a metacognitive paradigm was employed. Results indicated that modafinil specifically enhanced cognitive conflict performance and concomitantly increased activation in the inferior frontal gyrus and its functional communication with the dorsomedial prefrontal cortex. Exploratory analysis further revealed modafinil-enhanced basolateral amygdala reactivity to cognitive conflict, with stronger reactivity being associated with higher cognitive conflict performance. Whereas modafinil enhanced cognitive performance in the metacognitive paradigm, confidence indices remained unaffected. Overall, the present results suggest that modafinil has the potential to enhance cognitive conflict processing while leaving emotional conflict processing unaffected. On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information. The pattern of cognitive enhancing effects in the absence of effects on affective processing suggests a promising potential to enhance cognitive control in clinical populations.",2020,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.",[],"['Modafinil', 'modafinil']","['cognitive performance', 'cognitive and emotional conflict processing', 'cognitive conflict performance']",[],"[{'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0288783,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.","[{'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Daumann', 'Affiliation': 'LVR Clinics of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Daumann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. ben_becker@gmx.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0625-z']
119,31958404,"Effectiveness of post-partum family planning interventions on contraceptive use and method mix at 1 year after childbirth in Kinshasa, DR Congo (Yam Daabo): a single-blind, cluster-randomised controlled trial.","BACKGROUND
In rural Burkina Faso, a package of six low-technology, post-partum contraceptive interventions (ie, refresher training for providers, a counselling tool, supportive supervision, daily availability of contraceptive services, client appointment cards, and invitation letters to attend appointments for partners), aimed at strengthening existing primary health-care services and enhancing demand for them, doubled the use of modern contraceptives at 12 months post partum (ie, 55% uptake in intervention recipients vs 29% in routine-care users). This study assessed the effect of a similar package but in urban settings of Kinshasa province, Democratic Republic of the Congo, in an effort to reduce the unmet need for post-partum family planning.
METHODS
Yam Daabo was a multi-intervention, single-blinded, cluster-randomised controlled trial done in six primary health-care centres (clusters) in Kinshasa. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings. Only data analysts could be masked to cluster allocation. Health-care facilities were eligible if they provided a continuum of antenatal, delivery, and postnatal care, were well stocked with contraceptives, and were situated close to the main study centre. All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility. The main outcome was prevalence of use of modern contraceptives at 12 months after delivery. Analysis was by modified intention-to-treat using generalised linear mixed models or Fisher's exact test for small groups. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334).
FINDINGS
From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised. Of 690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters. Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis. At 12 months, 115 (46%) of 252 women in the intervention group and 94 (35%) of 267 in the control group were using modern contraceptives (adjusted prevalence ratio [PR] 1·58, 95% CI 0·74-3·38), with significant differences in the use of contraceptive implants (22% vs 6%; adjusted PR 4·36, 95% CI 1·96-9·70), but without difference in the use of short-acting contraceptives (23% vs 28%; 0·92, 0·29-2·98) and non-modern or inappropriate methods (7% vs 18%; 0·45, 0·13-1·54). There were no serious adverse events or maternal deaths related to the study.
INTERPRETATION
The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth. However, interferences from external family planning initiatives in the control group might have diminished differences between the services received. Such an intervention could be potentially relevant in similar contexts in DR Congo and other countries.
FUNDING
Government of France; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.",2020,The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth.,"['urban settings of Kinshasa province, Democratic Republic of the Congo', 'From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised', '690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters', 'Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis', 'Government of France', 'six primary health-care centres (clusters) in Kinshasa', 'All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility']","['six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings', 'post-partum family planning interventions']","['serious adverse events or maternal deaths', 'overall use of effective modern contraceptives', 'use of contraceptive implants', 'prevalence of use of modern contraceptives', 'Prevalence ratios']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",690.0,0.242724,The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth.,"[{'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, NSW, Australia. Electronic address: nguyen-toan.tran@unige.ch.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Seuc', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Tshikaya', 'Affiliation': 'Programme National de Santé de la Reproduction, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Mutuale', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Landoulsi', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Kini', 'Affiliation': 'World Health Organization Country Office in the Democratic Republic of the Congo, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Mbu Nkolomonyi', 'Affiliation': 'World Health Organization Country Office in the Democratic Republic of the Congo, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nyandwe Kyloka', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Félicité', 'Initials': 'F', 'LastName': 'Langwana', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Cuzin-Kihl', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kiarie', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mary Eluned', 'Initials': 'ME', 'LastName': 'Gaffield', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yodi', 'Affiliation': 'Programme National de Santé de la Reproduction, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Désiré', 'Initials': 'D', 'LastName': 'Mashinda Kulimba', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30546-7']
120,32318871,Healthcare resource utilization in advanced non-small-cell lung cancer: post hoc analysis of the randomized phase 3 REVEL study.,"PURPOSE
In REVEL, patients with advanced non-small-cell lung cancer (aNSCLC) and patients with increased tumor aggressiveness (rapid disease progression (RDP), platinum-refractory disease (PRD), and high symptom burden (HSB)) benefited from second-line treatment with ramucirumab plus docetaxel over placebo plus docetaxel. This post hoc analysis describes healthcare resource utilization (HCRU) associated with the treatment.
METHODS
aNSCLC patients who had progressed during or after first-line platinum-based chemotherapy were randomized to receive docetaxel and either ramucirumab or placebo until disease progression, unacceptable toxicity, withdrawal, or death. HCRU included hospitalizations, transfusions, and concomitant medications. Categorical variables (counts and percentages) were compared using Fisher's exact test. Continuous variables (mean, standard deviation (SD), median, minimum, and maximum) were compared using the Wilcoxon rank sum test.
RESULTS
Patient characteristics were largely similar between treatment arms. Within the intent-to-treat (ITT) population (n = 1253), the mean treatment duration was 19.7 and 16.9 weeks in the ramucirumab and control arms, respectively; 51.0% versus 54.9% of patients received subsequent anticancer therapy, respectively. Hospitalization rates were 41.9% versus 42.6% (p = 0.863), mean length of hospital stay was 14.5 days versus 11.3 days (p = 0.066), transfusion rates were 9.9% versus 12.3% (p = 0.206), and use of granulocyte colony-stimulating factors was 41.8% versus 36.6% (p = 0.063), respectively. No significant difference was observed in HCRU between treatment arms in both ITT population and in aggressive disease subgroups including RDP (n = 209), PRD (n = 360), and HSB (n = 497).
CONCLUSION
In REVEL, the addition of ramucirumab to docetaxel did not increase HCRU among patients with aggressive aNSCLC disease. These results may help inform economic evaluation of treatment for patients with aNSCLC.",2021,"No significant difference was observed in HCRU between treatment arms in both ITT population and in aggressive disease subgroups including RDP (n = 209), PRD (n = 360), and HSB (n = 497).
","['patients with advanced non-small-cell lung cancer (aNSCLC) and patients with increased tumor aggressiveness (rapid disease progression (RDP), platinum-refractory disease (PRD), and high symptom burden (HSB)) benefited from second-line treatment with', 'aNSCLC patients who had progressed during or after first-line platinum-based chemotherapy', 'advanced non-small-cell lung cancer', 'patients with aggressive aNSCLC disease', 'patients with aNSCLC']","['subsequent anticancer therapy', 'docetaxel and either ramucirumab or placebo', 'docetaxel', 'ramucirumab plus docetaxel over placebo plus docetaxel']","['Healthcare resource utilization', 'granulocyte colony-stimulating factors', 'HCRU included hospitalizations, transfusions, and concomitant medications', 'mean length of hospital stay', 'HCRU', 'transfusion rates', 'mean treatment duration', 'Continuous variables (mean, standard deviation (SD), median, minimum, and maximum', 'Hospitalization rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.135381,"No significant difference was observed in HCRU between treatment arms in both ITT population and in aggressive disease subgroups including RDP (n = 209), PRD (n = 360), and HSB (n = 497).
","[{'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at UCLA/TRIO-US Network, Santa Monica, CA, USA. egaron@mednet.ucla.edu.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Winfree', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Molife', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Zhanglin Lin', 'Initials': 'ZL', 'LastName': 'Cui', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Arriola', 'Affiliation': 'Hospital Del Mar, Barcelona, Spain.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mekhail', 'Affiliation': 'Florida Hospital Cancer Institute, Orlando, FL, USA.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Léon Bérard Cancer Centre, Lyon, France.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05459-0']
121,32320533,First-Year Economic and Quality of Life Effects of the RAINBOW Intervention to Treat Comorbid Obesity and Depression.,"OBJECTIVE
Obesity and depression are prevalent and often co-occurring conditions in the United States. The Research Aimed at Improving Both Mood and Weight (RAINBOW) randomized trial demonstrated the effectiveness of an integrated intervention for adults with both conditions. Characterizing the intervention's economic effects is important for broader dissemination and implementation.
METHODS
This study evaluated the cost (2018 US dollars) and health-related quality of life (HRQoL) impacts during RAINBOW's first year, comparing intervention (n = 204) and usual-care groups (n = 205). Outcomes included intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes from baseline using Euroqol-5D US utility weights.
RESULTS
RAINBOW's 1-year delivery cost per person was $2,251. Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027). Annual antidepressant medication spending had a larger, nonsignificant increase ($89 [95% CI: -$20 to $197]; P = 0.109). Annual spending on medical care services had a smaller, nonsignificant decrease (-$54 [95% CI: -$832 to $941]; P = 0.905). HRQoL had a nonsignificant increase (0.011 [95% CI: -0.025 to 0.047]; P = 0.546).
CONCLUSIONS
The RAINBOW intervention's economic value will depend on how its 1-year improvements in obesity and depression translate into long-term reduced morbidity, delayed mortality, or averted costs.",2020,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).",['adults with both conditions'],['integrated intervention'],"['Annual spending on medical care services', 'intervention delivery costs, differential changes in antidepressant medication spending compared with the pretrial year, differential changes in medical services spending compared with the pretrial year, and HRQoL changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0723905,"Compared with usual care, annual antidepressant medication days increased more (38 days [95% CI: 4 to 72]; P = 0.027).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Goldhaber-Fiebert', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Prince', 'Affiliation': 'Stanford Health Policy Group, Centers for Health Policy and Primary Care and Outcomes Research, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, School of Medicine, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington, USA.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, Department of Medicine, University of Illinois at Chicago, Chicago, Illinois, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22805']
122,32320537,The effectiveness of a mobile high-frequency chest wall oscillation (HFCWO) device for airway clearance.,"INTRODUCTION
High-frequency chest wall oscillation (HFCWO) is a commonly prescribed airway clearance technique (ACT) for patients whose ability to expectorate sputum is compromised. This study aimed to assess the effectiveness of a newly developed mobile ACT device (mHFCWO-The Monarch Airway Clearance System) in patients with cystic fibrosis (CF). A standard nonmobile HFCWO device (sHFCWO) was used as a comparator.
METHODOLOGY
This was a randomized, open-label, crossover pilot study. CF patients were treated with each device. Sputum was collected during and after each therapy session, while spirometry tests, Brody score assessment and functional respiratory imaging were performed before and after treatments.
RESULTS
Wet weight of sputum collected during and after treatment was similar for mHFCWO and sHFCWO (6.53 ± 8.55 vs 5.80 ± 5.82; P = .777). Interestingly, the mHFCWO treatment led to a significant decrease in specific airway volume (9.55 ± 9.96 vs 8.74 ± 9.70 mL/L; P < .001), while increasing specific airway resistance (0.10 ± 0.16 vs 0.16 ± 0.23 KPA*S; P < .001). These changes were heterogeneously-distributed throughout the lung tissue and were greater in the distal areas, suggesting a shift of mucus. Changes were accompanied by an overall improvement in the Brody index (57.71 ± 16.55 vs 55.20 ± 16.98; P = .001).
CONCLUSION
The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.",2020,"The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.",['patients with cystic fibrosis (CF'],"['mobile high-frequency chest wall oscillation (HFCWO) device', 'mobile ACT device (mHFCWO-The Monarch Airway Clearance System', 'High-frequency chest wall oscillation (HFCWO', 'standard nonmobile HFCWO device (sHFCWO']","['specific airway resistance', 'specific airway volume', 'Brody index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}]","[{'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0447732,"The newly developed mobile device provides airway clearance for CF patients comparable to a nonmobile sHFCWO device, yielding a change in airway geometry and patency by the shift of mucus from the more peripheral regions to the central airways.","[{'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Leemans', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Belmans', 'Affiliation': 'Fluidda nv, Kontich, Belgium.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Van Holsbeke', 'Affiliation': 'Fluidda nv, Kontich, Belgium.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'Department of Medical Affairs, Hillrom Company Inc., St. Paul, Minnesota.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Vissers', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Ides', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Verhulst', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Van Hoorenbeeck', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.'}]",Pediatric pulmonology,['10.1002/ppul.24784']
123,32318695,Effect of allopurinol on phosphocreatine recovery and muscle function in older people with impaired physical function: a randomised controlled trial.,"BACKGROUND
Allopurinol has vascular antioxidant effects and participates in purinergic signalling within muscle. We tested whether allopurinol could improve skeletal muscle energetics and physical function in older people with impaired physical performance.
METHODS
We conducted a randomised, double blind, parallel group, placebo-controlled trial, comparing 20 weeks of allopurinol 600 mg once daily versus placebo. We recruited community-dwelling participants aged 65 and over with baseline 6-min walk distance of <400 m and no contraindications to magnetic resonance imaging scanning. Outcomes were measured at baseline and 20 weeks. The primary outcome was post-exercise phosphocreatine (PCr) recovery rate measured using 31P magnetic resonance spectroscopy of the calf. Secondary outcomes included 6-min walk distance, short physical performance battery (SPPB), lean body mass measured by bioimpedance, endothelial function and quality of life.
RESULTS
In total, 124 participants were randomised, mean age 80 (SD 6) years. A total of 59 (48%) were female, baseline 6-min walk distance was 293 m (SD 80 m) and baseline SPPB was 8.5 (SD 2.0). Allopurinol did not significantly improve PCr recovery rate (treatment effect 0.10 units [95% CI, -0.07 to 0.27], P = 0.25). No significant changes were seen in endothelial function, quality of life, lean body mass or SPPB. Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]). This was more pronounced in those with high baseline oxidative stress and urate.
CONCLUSION
Allopurinol improved 6-min walk distance but not PCr recovery rate in older people with impaired physical function. Antioxidant strategies to improve muscle function for older people may need to be targeted at subgroups with high baseline oxidative stress.",2020,"Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]).","['older people with impaired physical performance', 'older people', 'recruited community-dwelling participants aged 65 and over with baseline 6-min walk distance of <400\xa0m and no contraindications to magnetic resonance imaging scanning', '124 participants were randomised, mean age 80 (SD 6) years', 'older people with impaired physical function']","['Allopurinol', 'allopurinol', 'placebo']","['post-exercise phosphocreatine (PCr) recovery rate', 'PCr recovery rate', '6-min walk distance, short physical performance battery (SPPB), lean body mass measured by bioimpedance, endothelial function and quality of life', 'endothelial function, quality of life, lean body mass or SPPB', 'skeletal muscle energetics and physical function', 'phosphocreatine recovery and muscle function', '6-min walk distance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0031634', 'cui_str': 'fosfocreatine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",124.0,0.800177,"Allopurinol improved 6-min walk distance (treatment effect 25 m [95% 4-46, P = 0.02]).","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Clarke', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hutcheon', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gingles', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Priba', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Nicholas', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cavin', 'Affiliation': 'Department of Medical Physics, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Sumukadas', 'Affiliation': 'Department of Medicine for the Elderly, Ninewells Hospital, NHS Tayside, Dundee, UK.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}]",Age and ageing,['10.1093/ageing/afaa061']
124,32092760,Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin.,"Twenty-four hours after administration, ketamine exerts rapid and robust antidepressant effects that are thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. Twenty patients suffering a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo 2 h prior to the intravenous administration of ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS). Rapamycin pretreatment did not alter the antidepressant effects of ketamine at the 24-h timepoint. Over the subsequent 2-weeks, we found a significant treatment by time interaction (F (8,245) = 2.02, p = 0.04), suggesting a prolongation of the antidepressant effects of ketamine by rapamycin. Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively). In summary, single dose rapamycin pretreatment failed to block the antidepressant effects of ketamine, but it prolonged ketamine's antidepressant effects. This observation raises questions about the role of systemic vs. local blockade of mTORC1 in the antidepressant effects of ketamine, provides preliminary evidence that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that contribute to depression relapse after ketamine administration.",2020,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).",['Twenty patients suffering a major depressive episode'],"['rapamycin\u2009+\u2009ketamine', 'placebo', 'ketamine', 'Rapamycin', 'rapamycin', 'placebo\u2009+\u2009ketamine', 'rapamycin, an mTORC1 inhibitor, prior to receiving ketamine', 'oral rapamycin']","['remission rates', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0810233,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@yale.edu.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Formica', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0644-9']
125,32184194,Tai Chi is an effective form of exercise to reduce markers of frailty in older age.,"Frailty affects the quality of life of older age adults by limiting mobility, reducing physiological reserve and reducing independence. The frailty phenotype is typically characterised by exhaustion, loss or lack of physical activity, weight loss and weakness, although more recently there have been proposals to extend the frailty criteria to include physiological characteristics such as inflammation, oxidative stress and vascular function. Exercise has the potential to prevent, delay or even reverse frailty, but not all exercise is perceived as suitable for an older age population. The purpose of this study was to test Tai Chi and Zumba Gold® as exercise interventions in older age adults (65 to 75 years old) to improve characteristics related to the frailty phenotype. Muscle strength and flexibility (functional fitness as a measure of weakness), cardiorespiratory fitness, blood pressure, vascular function (FMD), markers of oxidative stress (total antioxidant capacity, malondialdehyde, 8-isoprostane, protein carbonyl), inflammation (CRP) and aspects of wellbeing related to exhaustion were assessed at baseline (pre-), 6 weeks (mid-) and 12 weeks (post-intervention). Both Tai Chi and Zumba Gold® improved systolic blood pressure, vascular function, and functional fitness following the 12 week intervention to a similar extent. Furthermore Antioxidant capacity was significantly increased (303 ± 15.56 vs. 336 ± 18.82 μm; p = 0.0028) and lipid oxidation significantly reduced (36.41 ± 6.4 vs 13.49 ± 2.5 pg/ml; p = 0.0042) after 12 weeks of Tai Chi compared to baseline. Anxiety, physical and mental fatigue decreased in both groups, with a greater decrease in mental fatigue in the Tai Chi group. Taken together, these changes suggest that Tai Chi has the potential to reduce outcomes related to the extended frailty phenotype in older age adults.",2020,"Anxiety, physical and mental fatigue decreased in both groups, with a greater decrease in mental fatigue in the Tai Chi group.","['older age adults (65 to 75\u202fyears old', 'older age adults', 'older age']",['Tai Chi and Zumba Gold®'],"['Anxiety, physical and mental fatigue', 'mental fatigue', 'systolic blood pressure, vascular function, and functional fitness', 'Muscle strength and flexibility (functional fitness as a measure of weakness), cardiorespiratory fitness, blood pressure, vascular function (FMD), markers of oxidative stress (total antioxidant capacity, malondialdehyde, 8-isoprostane, protein carbonyl), inflammation (CRP) and aspects of wellbeing related to exhaustion', 'lipid oxidation', 'Furthermore Antioxidant capacity']","[{'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]",,0.0341761,"Anxiety, physical and mental fatigue decreased in both groups, with a greater decrease in mental fatigue in the Tai Chi group.","[{'ForeName': 'Nor Fadila', 'Initials': 'NF', 'LastName': 'Kasim', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Faculty of Sport Science and Coaching, Sultan Idris Education University Malaysia.'}, {'ForeName': 'Jet', 'Initials': 'J', 'LastName': 'Veldhuijzen van Zanten', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Centre for Musculoskeletal Ageing Research, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Aldred', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Edgbaston, Birmingham, UK; Centre for Human Brain Health, University of Birmingham, Edgbaston, Birmingham, UK. Electronic address: s.aldred.1@bham.ac.uk.'}]",Experimental gerontology,['10.1016/j.exger.2020.110925']
126,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z']
127,32299284,Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs.,"Background Hospitals commonly provide a short-term supply of free P2Y 12 inhibitors at discharge after myocardial infarction, but it is unclear if these programs improve medication persistence and outcomes. The ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) trial randomized hospitals to usual care versus waived P2Y 12 inhibitor copayment costs for 1-year post-myocardial infarction. Whether the impact of this intervention differed between hospitals with and without pre-existing medication assistance programs is unknown. Methods and Results In this post hoc analysis of the ARTEMIS trial, we examined the associations of pre-study free medication programs and the randomized copayment voucher intervention with P2Y 12 inhibitor persistence (measured by pharmacy fills and patient report) and major adverse cardiovascular events using logistic regression models including a propensity score. Among 262 hospitals, 129 (49%) offered pre-study free medication assistance. One-year P2Y 12 inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively). The randomized copayment voucher intervention improved persistence, assessed by pharmacy fills, in both hospitals with (53.6% versus 44.0%, adjusted odds ratio 1.45, 95% CI, 1.20-1.75) and without (59.0% versus 48.3%, adjusted odds ratio 1.46, 95% CI, 1.25-1.70) free medication programs ( P interaction =0.71). Differences in patient-reported persistence were not significant after adjustment. Conclusions While hospitals commonly report the ability to provide free short-term P2Y 12 inhibitors, we did not find association of this with medication persistence or major adverse cardiovascular events among patients with insurance coverage for prescription medication enrolled in the ARTEMIS trial. An intervention that provided copayment assistance vouchers for 1 year was successful in improving medication persistence in hospitals with and without pre-existing short-term medication programs. Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02406677.",2020,"One-year P2Y 12 inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively).","['Hospitals', '262 hospitals, 129 (49%) offered pre-study free medication assistance', 'patients with insurance coverage for prescription medication enrolled']","['Copayment Reduction Intervention', 'Registration URL', 'usual care versus waived P2Y 12 inhibitor copayment costs']","['inhibitor persistence and major adverse cardiovascular events risks', 'Medication Persistence and Cardiovascular Events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}, {'cui': 'C2350288', 'cui_str': 'Medication Persistence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.178778,"One-year P2Y 12 inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively).","[{'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Doll', 'Affiliation': 'VA Puget Sound Health Care System Seattle WA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'Duke Clinical Research Institute Durham NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute Durham NC.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'University of California-Los Angeles CA.'}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences Brigham and Women's Hospital and Harvard Medical School Boston MA.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Fonseca', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Bhalla', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Eudicone', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke University Durham NC.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke University Durham NC.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014975']
128,32306797,Pharmacodynamic Effects of Vorapaxar in Prior Myocardial Infarction Patients Treated With Potent Oral P2Y 12 Receptor Inhibitors With and Without Aspirin: Results of the VORA-PRATIC Study.,"Background Vorapaxar as an adjunct to dual antiplatelet therapy (DAPT) reduces thrombotic events in patients with prior myocardial infarction at the expense of increased bleeding. Withdrawal of aspirin has emerged as a bleeding reduction strategy. The pharmacodynamic effects of vorapaxar with potent P2Y 12 inhibitors as well as the impact of dropping aspirin is unexplored and represented the aim of the VORA-PRATIC (Vorapaxar Therapy in Patients With Prior Myocardial Infarction Treated With Newer Generation P2Y 12 Receptor Inhibitors Prasugrel and Ticagrelor) study. Methods and Results Post-myocardial infarction patients (n=130) on standard DAPT (aspirin+prasugrel or ticagrelor) were randomized to 1 of 3 arms: (1) triple therapy: aspirin+prasugrel/ticagrelor+vorapaxar; (2) dual therapy (drop aspirin): prasugrel/ticagrelor+vorapaxar; (3) DAPT: aspirin+prasugrel/ticagrelor. Pharmacodynamic assessments were performed at 3 time points (baseline and 7 and 30 days). Vorapaxar reduced CAT (collagen-ADP-TRAP)-induced platelet aggregation, a marker of platelet-mediated global thrombogenicity (triple therapy versus DAPT at 30 days: mean difference=-27; 95% CI,-35 to -19; P <0.001; primary end point). This effect was attenuated but still significant in the absence of aspirin (dual therapy versus DAPT at 30 days: mean difference=-15; 95% CI,-23 to -7; P <0.001; between-group comparisons, P <0.05). Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength. There were no differences in markers of P2Y 12 reactivity. Markers sensitive to aspirin-induced effects increased ( P <0.001) in the dual-therapy arm. Conclusions In post-myocardial infarction patients treated with potent P2Y 12 inhibitors, vorapaxar reduces platelet-driven global thrombogenicity, an effect that persisted, albeit attenuated, in the absence of aspirin and without affecting markers of P2Y 12 reactivity or clot kinetics. The clinical implications of these PD observations warrant future investigation. Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02545933.",2020,"Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength.","['Patients', 'Prior Myocardial Infarction Patients Treated With Potent Oral P2Y 12 Receptor Inhibitors With and Without', 'patients with prior myocardial infarction']","['aspirin', 'Vorapaxar', 'dual antiplatelet therapy (DAPT', 'triple therapy: aspirin+prasugrel/ticagrelor+vorapaxar; (2) dual therapy (drop aspirin): prasugrel/ticagrelor+vorapaxar; (3) DAPT: aspirin+prasugrel/ticagrelor', 'standard DAPT (aspirin+prasugrel or ticagrelor', 'Aspirin']","['platelet-driven global thrombogenicity', 'thrombin generation and clot strength', 'Vorapaxar reduced CAT (collagen-ADP-TRAP)-induced platelet aggregation, a marker of platelet-mediated global thrombogenicity', 'thrombotic events', 'Vorapaxar abolished TRAP-induced aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C1271704', 'cui_str': 'Collagen ADP'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C1268819', 'cui_str': 'Induced platelet aggregation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}]",,0.0571621,"Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Franchi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rollini', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Faz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Malhar', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Maryuri', 'Initials': 'M', 'LastName': 'Briceno', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Wali', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nawaz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Silva', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Shaikh', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Maaliki', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Kerolos', 'Initials': 'K', 'LastName': 'Fahmi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Latonya', 'Initials': 'L', 'LastName': 'Been', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Pineda', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Suryadevara', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soffer', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Zenni', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Jennings', 'Affiliation': 'CirQuest Labs Memphis TN.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Bass', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015865']
129,32111414,"Re: Ola Bratt, Erik Holmberg, Ove Andrén, et al. The Value of an Extensive Transrectal Repeat Biopsy with Anterior Sampling in Men on Active Surveillance for Low-risk Prostate Cancer: A Comparison from the Randomised Study of Active Monitoring in Sweden (SAMS). Eur Urol 2019;76:461-6.",,2020,,"['Men on Active Surveillance for Low-risk Prostate Cancer', 'Sweden (SAMS']",['Extensive Transrectal Repeat Biopsy with Anterior Sampling'],[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}]",[],,0.0213149,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy. Electronic address: montorsi.francesco@hsr.it.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gandaglia', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fossati', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Salonia', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}]",European urology,['10.1016/j.eururo.2020.01.023']
130,32111761,Effects of Coffee Intake on Oxidative Stress During Aging-related Alterations in Periodontal Tissue.,"BACKGROUND/AIM
The purpose of this study was to determine the anti-aging effects of coffee intake on oxidative stress in rat periodontal tissue and alveolar bone loss.
MATERIALS AND METHODS
Male Fischer 344 rats (8 weeks old) were randomized to four groups; the baseline group immediately sacrificed, the control group fed with normal powdered food for 8 weeks, and the experimental groups fed with powdered food containing 0.62% or 1.36% coffee components for 8 weeks.
RESULTS
Alveolar bone loss and gingival level of 8-hydroxydeoxyguanosine were significantly lower in the 1.36% coffee group than in the control group. Nuclear factor erythroid 2-related factor 2 translocation to the nucleus was significantly higher in the 1.36% coffee group than in the control group.
CONCLUSION
Continuous intake of 1.36% coffee could prevent age-related oxidative stress in the periodontal tissue and alveolar bone loss, possibly by up-regulating the Nrf2 signaling pathway.",2020,"RESULTS
Alveolar bone loss and gingival level of 8-hydroxydeoxyguanosine were significantly lower in the 1.36% coffee group than in the control group.","['rat periodontal tissue and alveolar bone loss', 'Male Fischer 344 rats (8 weeks old']","['coffee intake', 'Coffee Intake', 'control group fed with normal powdered food for 8 weeks, and the experimental groups fed with powdered food containing 0.62% or 1.36% coffee components for 8 weeks']","['Nuclear factor erythroid 2-related factor 2 translocation to the nucleus', 'Oxidative Stress', 'Alveolar bone loss and gingival level of 8-hydroxydeoxyguanosine', 'oxidative stress']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0031104', 'cui_str': 'Tooth Supporting Structures'}, {'cui': 'C0002382', 'cui_str': 'Alveolar Bone Atrophy'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0556160', 'cui_str': 'Coffee intake (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4708912', 'cui_str': '1.36 (qualifier value)'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0002382', 'cui_str': 'Alveolar Bone Atrophy'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0050078', 'cui_str': ""2'-deoxy-8-oxo-7,8-dihydroguanosine""}]",,0.0303883,"RESULTS
Alveolar bone loss and gingival level of 8-hydroxydeoxyguanosine were significantly lower in the 1.36% coffee group than in the control group.","[{'ForeName': 'Terumasa', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Preventive Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan t-maru@md.okayama-u.ac.jp.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Yoneda', 'Affiliation': 'Department of Preventive Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Hisataka', 'Initials': 'H', 'LastName': 'Miyai', 'Affiliation': 'Department of Preventive Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Azuma', 'Affiliation': 'Department of Community Oral Health, Asahi University School of Dentistry, Mizuho, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Tomofuji', 'Affiliation': 'Department of Community Oral Health, Asahi University School of Dentistry, Mizuho, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ekuni', 'Affiliation': 'Department of Preventive Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Department of Preventive Dentistry, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}]","In vivo (Athens, Greece)",['10.21873/invivo.11815']
131,32092502,Osteosarcopenic obesity markers following elastic band resistance training: A randomized controlled trial.,"The main purpose of present study was to investigate the effects of elastic band resistance training (EBRT) on muscle quality (MQ), serum osteosarcopenic obesity (OSO) biomarkers, bone density and functional profile in women living with OSO syndrome. The eligible participants, aged 65 to 80 years, were selected by a physician. Accordingly, a total number of 63 women with OSO syndrome were recruited and assessed using a dual energy X-ray absorptiometry (DXA) instrument, body mass index (BMI) > 30 kg/m 2 , -2.5 ≤ T-score ≤ -1.0 of L1-L4, and/or total femur or femoral neck, and gait speed (10-meter walk test (10MWT)) ≤ 1 (m/s 2 ). The 12-week supervised EBRT was designed to train all major muscle groups for 3 times per week. In the first two sessions, the participants became familiar with targeted number of repetitions (TNRs) and OMNI-resistance exercise scale (OMNI-RES) to control exercise intensity. Following an adaptation phase of 4 weeks (1 set of 12 rep) using low resistance (yellow Thera-Band), exercise intensity progressively increased by adapting the resistance of the elastic band (based on the Thera-Band® force-elongation table) from yellow to red and further to black. The participants in the control group also received telephone contacts or face-to-face interviews on a weekly basis to maintain their typical diet and activity habits. A two-way repeated measures ANOVA was employed to determine the main changes (2 times×2 groups) after 12 weeks of training. Partial eta-squared (ηp 2 ) was additionally used to determine ES in ANOVA tests. At all the stages of data analysis in this RCT, intention-to-treat (ITT) analysis was performed. The results of two-way ANOVA showed significant elevations in E2 (F = 7.881, p = 0.006, ES = 0.079), MQ (F = 4.225, p = 0.043, ES = 0.044), OSO Z-score (F = 7.091, p = 0.030, ES = 0.069), 30-s chair stand test (F = 4.599, p = 0.036, ES = 0.063) and hand grip strength (F = 6.411, p = 0.013, ES = 0.065) in the experimental group compared with those in the controls. Besides, there were no significant differences in CAF (F = 0.456, p = 0.501, ES = 0.005), CTX-I (F = 3.427, p = 0.067, ES = 0.036), adiponectin (F = 2.733, p = 0.102, ES = 0.029), sTnT (F = 3.245, p = 0.075, ES = 0.034), sclerostin (F = 2.927, p = 0.091, ES = 0.034), gait speed (10MWT) (F = 1.524, p = 0.220, ES = 0.016), 6MWT (F = 1.169, p = 0.284, ES = 0.017) and TUG (F = 1.502, p = 0.225, ES = 0.022), BMI (F = 0.354, p = 0.553, ES = 0.004), BFP (F = 2.888, p = 0.093, ES = 0.030), body mass content (BMC) (F = 0.030, p = 0.862, ES = 0.001) and BMD (F = 0.335, p = 0.564, ES = 0.004) between study groups. Taken together, the results of this study illustrated significant differences only in some OSO markers between groups after 48 h of chronic EBRT in women affected with OSO syndrome. Further research is thus recommended to design machine-based and elastic band-based training regimes at different intensities and volumes.",2020,"Besides, there were no significant differences in CAF (F = 0.456, p = 0.501, ES = 0.005), CTX-I (F = 3.427, p = 0.067, ES = 0.036), adiponectin (F = 2.733, p = 0.102, ES = 0.029), sTnT","['women living with OSO syndrome', 'eligible participants, aged 65 to 80\u202fyears, were selected by a physician', '63 women with OSO syndrome']","['sTnT', 'elastic band resistance training', 'telephone contacts or face-to-face interviews on a weekly basis to maintain their typical diet and activity habits', 'elastic band resistance training (EBRT']","['sclerostin', 'adiponectin', 'muscle quality (MQ), serum osteosarcopenic obesity (OSO) biomarkers, bone density and functional profile', 'gait speed (10MWT', 'MQ', 'OSO Z-score', '≤\u202fT-score\u202f≤\u202f-1.0 of L1-L4, and/or total femur or femoral neck, and gait speed (10-meter walk test (10MWT', 'Osteosarcopenic obesity markers', 'familiar with targeted number of repetitions (TNRs) and OMNI-resistance exercise scale (OMNI-RES) to control exercise intensity', 'body mass content (BMC', 'BFP', 'BMI', 'BMD', 'CAF', 'hand grip strength', 'OSO markers']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1264657', 'cui_str': 'Mass content'}, {'cui': 'C0045933', 'cui_str': 'BFP'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",63.0,0.0415252,"Besides, there were no significant differences in CAF (F = 0.456, p = 0.501, ES = 0.005), CTX-I (F = 3.427, p = 0.067, ES = 0.036), adiponectin (F = 2.733, p = 0.102, ES = 0.029), sTnT","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'SavariNikoo', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Soltani', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Bahramzadeh', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}]",Experimental gerontology,['10.1016/j.exger.2020.110884']
132,32151735,Functional and traditional training improve muscle power and reduce proinflammatory cytokines in older women: A randomized controlled trial.,"BACKGROUND
Aging is a natural process that, even in the nonattendance of complex diseases, is associated with a numerous behavioral change that attributes reduced muscle mass, power, strength and function. In addition, aging linked to low-grade inflammatory status, characterized by increased plasma concentrations of inflammatory cytokines such as TNF-α and IL-6. Physical exercise is the main non-pharmacological strategy for improving the physical fitness of the aged individuals. However, it is still controversial whether exercise can reduce aging-mediated inflammation.
OBJECTIVE
To analyze the effects of functional (FT) and traditional (TT) training practice on muscle power and inflammatory profile in physically active older women.
METHODS
The study has been performed for twenty-six weeks in which twenty-four weeks utilized for training sessions and two weeks for physical and biochemical assessments. Forty-three older women (age FT: 64.25 ± 4.70, range: 60-75; TT: 64.90 ± 3.03, range: 60-71; Control: 65.91 ± 5.79, range: 60-75) were randomly divided into three groups: Functional (FT; n = 16); Traditional (TT; n = 16) training groups; and Control Group (CG; n = 11) respectively. Muscle power tests were performed by push (Bench press) and squatting (Squat) actions. The jumping ability was performed through Counter Movement Jump (CMJ). In addition, isometric strength were assessed by Hand Grip Test. Plasma cytokine concentration was measured using flow cytometry.
RESULTS
Functional and traditional training sessions subjected to aged women demonstrated a significant enhancement in their physical activity and muscle power. The trained individuals from above two groups showed significant improvements in all analyzed parameters excluding hand-grip. Functional and traditional training exercise reduced the plasma concentrations of TNF-α (FT: p = 0.0001; TT: p = 0.0410) and whereas FT group has reduced IL-6 (p = 0.0072), but did not affect the alterations of pre and post measurements of IL-2 (FT: p = 0.0651; TT: p = 0.2146) and IL-10 values (FT: p = 0.2658; TT: p = 0.3116). There was no significant difference in any of the test parameters between FT and TT groups.
CONCLUSION
The functional and traditional training practices showed equivalent beneficial outcomes by increasing muscle power and reducing systemic markers associated with inflammation.",2020,Functional and traditional training exercise reduced the plasma concentrations of TNF-α (FT: p = 0.0001; TT: p = 0.0410) and whereas FT group has reduced IL-6,"['older women', 'physically active older women', 'Forty-three older women (age FT: 64.25\xa0±\xa04.70, range: 60-75; TT: 64.90\xa0±\xa03.03, range: 60-71; Control: 65.91\xa0±\xa05.79, range: 60-75']","['Functional and traditional training', 'functional (FT) and traditional (TT) training practice']","['proinflammatory cytokines', 'Plasma cytokine concentration', 'isometric strength', 'IL-10 values', 'IL-6', 'physical activity and muscle power', 'plasma concentrations of TNF-α']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",43.0,0.0385862,Functional and traditional training exercise reduced the plasma concentrations of TNF-α (FT: p = 0.0001; TT: p = 0.0410) and whereas FT group has reduced IL-6,"[{'ForeName': 'Alan Bruno Silva', 'Initials': 'ABS', 'LastName': 'Vasconcelos', 'Affiliation': 'Department of Physiology, Post Graduate Program in Physiology Sciences, Federal University of Sergipe, São Cristóvão, Brazil. Electronic address: abs.vasconcelos@gmail.com.'}, {'ForeName': 'Antônio Gomes de', 'Initials': 'AG', 'LastName': 'Resende-Neto', 'Affiliation': 'Department of Physical Education, Post Graduate Program in Physical Education, Federal University of Sergipe, São Cristóvão, Brazil.'}, {'ForeName': 'Albernon Costa', 'Initials': 'AC', 'LastName': 'Nogueira', 'Affiliation': 'Department of Physical Education, Post Graduate Program in Physical Education, Federal University of Sergipe, São Cristóvão, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Aragão-Santos', 'Affiliation': 'Department of Physiology, Post Graduate Program in Physiology Sciences, Federal University of Sergipe, São Cristóvão, Brazil.'}, {'ForeName': 'Marcos Raphael Pereira', 'Initials': 'MRP', 'LastName': 'Monteiro', 'Affiliation': 'Department of Physiology, Post Graduate Program in Physiology Sciences, Federal University of Sergipe, São Cristóvão, Brazil.'}, {'ForeName': 'Gilberto Santos', 'Initials': 'GS', 'LastName': 'Morais Junior', 'Affiliation': 'Post-graduate Program in Health Sciences, University of Brasília (UnB-DF), Brasília, Brazil.'}, {'ForeName': 'Gleiciane Gontijo', 'Initials': 'GG', 'LastName': 'Avelar', 'Affiliation': 'Post-graduate Program in Health Sciences, University of Brasília (UnB-DF), Brasília, Brazil.'}, {'ForeName': 'Enilton Aparecido', 'Initials': 'EA', 'LastName': 'Camargo', 'Affiliation': 'Department of Physiology, Post Graduate Program in Physiology Sciences, Federal University of Sergipe, São Cristóvão, Brazil.'}, {'ForeName': 'Otávio de Toledo', 'Initials': 'OT', 'LastName': 'Nóbrega', 'Affiliation': 'Post-graduate Program in Health Sciences, University of Brasília (UnB-DF), Brasília, Brazil.'}, {'ForeName': 'Marzo Edir', 'Initials': 'ME', 'LastName': 'Da Silva-Grigoletto', 'Affiliation': 'Department of Physiology, Post Graduate Program in Physiology Sciences, Federal University of Sergipe, São Cristóvão, Brazil; Department of Physical Education, Post Graduate Program in Physical Education, Federal University of Sergipe, São Cristóvão, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.110920']
133,32312685,Comparison between stroke triage scale and emergency severity Index to triage patients with neurological Complaints: A randomized clinical trial.,,2020,,['triage patients with neurological Complaints'],[],[],"[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",[],[],,0.0226541,,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abedi', 'Affiliation': 'Department of Nursing, Esfarayen Faculty of Medical Sciences, Esfarayen, Iran; Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: Abedia1371@gmail.com.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mirhaghi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: mirhaghia@mums.ac.ir.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: Ebrahimimn@mums.ac.ir.'}, {'ForeName': 'Seyyed Reza', 'Initials': 'SR', 'LastName': 'Mazloum', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: MazlomR@mums.ac.ir.'}]",International emergency nursing,['10.1016/j.ienj.2020.100871']
134,31904855,"High-Dose Intravenous Immunoglobulin Is Effective in Painful Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial.","OBJECTIVES
The efficacy and safety of high-dose intravenous immunoglobulin (IVIG) in treatment-resistant diabetic painful polyneuropathy (DPN) were assessed.
DESIGN
This was a randomized, double-blind, placebo-controlled, multicenter trial (EudraCT 2010-023883-42).
SETTING
This trial was conducted at eight sites in Italy with a neurology specialist level of care.
SUBJECTS
Twenty-six diabetic patients with DPN who reported baseline severity of pain >60 units (mm) on a VAS scale at enrollment and were resistant to antidepressants and antiepileptic drugs were enrolled; 23 were randomized (11 in the IVIG arm and 12 in the placebo arm). All patients completed the study and were evaluated. All patients were Caucasian, 15 were male, and 21 had a diagnosis of type II diabetes.
METHODS
IVIG (0.4 g/kg/d) or placebo was given for five consecutive days. Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments were performed at visits: baseline, start of therapy (one week later), end of therapy (five days later), and follow-up (four and eight weeks later).
RESULTS
The study achieved its prespecified primary end point of ≥50% pain reduction at four weeks after IVIG, achieved in seven of 11 patients (63.6%) in the IVIG group vs zero of 12 in the placebo group (P = 0.0013). Only two adverse events were reported during the study: one patient in the treatment arm reported a mild ""dermatitis psoriasiform,"" whereas one patient from the placebo group reported a mild ""influenza.""
CONCLUSIONS
Treatment with IVIG at the dose given was efficacious and safe for patients with DPN resistant to standard therapies.",2020,"Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments were performed at visits: baseline, start of therapy (one week later), end of therapy (five days later), and follow-up (four and eight weeks later).
","['Twenty-six diabetic patients with DPN who reported baseline severity of pain', 'All patients were Caucasian, 15 were male, and 21 had a diagnosis of type II diabetes', '60 units (mm) on a VAS scale at enrollment and were resistant to antidepressants and antiepileptic drugs were enrolled; 23 were randomized (11 in the IVIG arm and 12 in the', 'eight sites in Italy with a neurology specialist level of care']","['placebo', 'Placebo', 'high-dose intravenous immunoglobulin (IVIG', 'Immunoglobulin']","['Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments', 'mild ""influenza', 'pain reduction', 'mild ""dermatitis psoriasiform']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0262985', 'cui_str': 'Psoriasiform eczema (disorder)'}]",26.0,0.670239,"Pain intensity (visual analog scale, Neuropathic Pain Symptom Inventory) and quality of life (36-Item Short-Form Health Survey, Clinical/Patient Global Impression of Change questionnaires) assessments were performed at visits: baseline, start of therapy (one week later), end of therapy (five days later), and follow-up (four and eight weeks later).
","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Jann', 'Affiliation': 'Department of Neurology, Niguarda General Hospital, Milan, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Fazio', 'Affiliation': 'Department of Neuromuscular Disease, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Department of Neuroscience, University of Turin, Torino, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Toscano', 'Affiliation': 'Department of Neuroscience, Psychiatry and Anesthesiology, University of Messina, Messina, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Schenone', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Health, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Gerolama Alessandra', 'Initials': 'GA', 'LastName': 'Marfia', 'Affiliation': 'Department of Neuroscience, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'Department of Neuroscience, Mental Health and Sensory Organs, Rome University ""Sapienza,"" Sant\'Andrea Hospital, Rome, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'De Toni Franceschini', 'Affiliation': 'Department of Neurology, Alesssandro Manzoni General Hospital, Lecco, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mazzeo', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Grandis', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Health, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Velardo', 'Affiliation': 'Department of Neuromuscular Disease, San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Mataluni', 'Affiliation': 'Department of Neuroscience, University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Erdita', 'Initials': 'E', 'LastName': 'Peci', 'Affiliation': 'Department of Neuroscience, University of Turin, Torino, Italy.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz331']
135,32310854,Vildagliptin vs. insulin treatment alone in diabetic acute coronary syndrome patients.,"BACKGROUND
Vildagliptin, an oral antidiabetic of the dipeptidyl peptidase-4 (DPP-4) inhibitor drugs, exhibits an overall low risk of hypoglycemia with less frequent hypoglycemic events in type 2 diabetes mellitus (T2DM) patients than other antidiabetic drugs. We hypothesized that among hospitalized acute coronary syndrome (ACS) patients, the addition of vildagliptin to subcutaneous insulin therapy would reduce the risk of hypoglycemic events.
METHODS
One hundred ACS T2DM adult patients naive to DPP-4 inhibitors were enrolled during admission to the ICCU. Patients were divided into two randomized controlled groups: a subcutaneous rapid-acting insulin-only therapy group and an oral vildagliptin plus subcutaneous insulin group. The trial was open label with no placebo arm. Mean glucose values, insulin values given for correction per hospitalization, and the number of hypoglycemic events (glucose < 70 mg/dL) were documented.
RESULTS
Eight hypoglycemia events occurred in the insulin-only group and none in the insulin plus DPP-4 inhibitor group (P < 0.001). Patients with acute myocardial infarction experienced a higher number of hypoglycemic events compared with unstable angina diagnosed patients. No significant differences were found regarding glucose level (P = 0.462) and administered insulin units (P = 0.639).
CONCLUSIONS
In T2DM patients, the addition of DPP-4 inhibitors to routine subcutaneous insulin therapy may significantly reduce hypoglycemic events while maintaining acceptable recommended ranges of glucose. Further studies on a larger scale are required to verify these results and to support that DPP-4 inhibitors added to today's standard insulin-only treatment in hospitalized diabetic ACS patients may improve overall glycemic control and provide a potential treatment option in this challenging clinical setting.",2021,"No significant differences were found regarding glucose level (P = 0.462) and administered insulin units (P = 0.639).
","['hospitalized acute coronary syndrome (ACS) patients', 'Patients with acute myocardial infarction', 'One hundred ACS T2DM adult patients naive to DPP-4 inhibitors were enrolled during admission to the intensive cardiac care unit (ICCU', 'hospitalized diabetic ACS patients', 'diabetic acute coronary syndrome patients', 'type 2 diabetes mellitus (T2DM) patients than other conventional antidiabetic drugs']","['Vildagliptin', 'vildagliptin', 'subcutaneous rapid-acting insulin-only therapy group and an oral vildagliptin plus subcutaneous insulin group', 'Vildagliptin vs. insulin']","['glucose level', 'hypoglycemic events', 'hypoglycemia events', 'Mean glucose values, insulin values given for correction per hospitalization, and the number of hypoglycemic events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0585045', 'cui_str': 'During admission'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",100.0,0.0255526,"No significant differences were found regarding glucose level (P = 0.462) and administered insulin units (P = 0.639).
","[{'ForeName': 'Idit', 'Initials': 'I', 'LastName': 'Dobrecky-Mery', 'Affiliation': 'Department of Cardiology, Bnai-Zion Medical Center.'}, {'ForeName': 'Adir', 'Initials': 'A', 'LastName': 'Sommer', 'Affiliation': 'The Ruth and Bruce Rappaport Faculty of Medicine, Technion - Israel Institute of Technology, Haifa, Israel.'}]",Coronary artery disease,['10.1097/MCA.0000000000000901']
136,32315461,Impact of STEADI-Rx: A Community Pharmacy-Based Fall Prevention Intervention.,"OBJECTIVES
To evaluate the effects of a community pharmacy-based fall prevention intervention (STEADI-Rx) on the risk of falling and use of medications associated with an increased risk of falling.
DESIGN
Randomized controlled trial.
SETTING
A total of 65 community pharmacies in North Carolina (NC).
PARTICIPANTS
Adults (age ≥65 years) using either four or more chronic medications or one or more medications associated with an increased risk of falling (n = 10,565).
INTERVENTION
Pharmacy staff screened patients for fall risk using questions from the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) algorithm. Patients who screened positive were eligible to receive a pharmacist-conducted medication review, with recommendations sent to patients' healthcare providers following the review.
MEASUREMENTS
At intervention pharmacies, pharmacy staff used standardized forms to record participant responses to screening questions and information concerning the medication reviews. For participants with continuous Medicare Part D/NC Medicaid coverage (n = 3,212), the Drug Burden Index (DBI) was used to assess exposure to high-risk medications, and insurance claims records for emergency department visits and hospitalizations were used to assess falls.
RESULTS
Among intervention group participants (n = 4,719), 73% (n = 3,437) were screened for fall risk. Among those who screened positive (n = 1,901), 72% (n = 1,373) received a medication review; and 27% (n = 521) had at least one medication-related recommendation communicated to their healthcare provider(s) following the review. A total of 716 specific medication recommendations were made. DBI scores decreased from the pre- to postintervention period in both the control and the intervention group. However, the amount of change over time did not differ between these two groups (P = .66). Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58).
CONCLUSION
We successfully implemented STEADI-Rx in the community pharmacy setting. However, we found no differences in fall risk or the use of medications associated with increased risk of falling between the intervention and control groups. J Am Geriatr Soc 68:1778-1786, 2020.",2020,"Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58).
","['A total of 65 community pharmacies in North Carolina (NC', 'participants with continuous Medicare Part D/NC Medicaid coverage (n = 3,212), the Drug Burden Index (DBI) was used to assess exposure to high-risk medications, and insurance claims records for emergency department visits and hospitalizations were used to assess falls', 'Adults (age ≥65\u2009years) using either four or more chronic medications or one or more medications associated with an increased risk of falling (n = 10,565', 'Among those who screened positive (n = 1,901), 72% (n = 1,373) received a medication review; and 27% (n = 521) had at least one medication-related recommendation communicated to their healthcare provider(s) following the review', ""Patients who screened positive were eligible to receive a pharmacist-conducted medication review, with recommendations sent to patients' healthcare providers following the review""]",['community pharmacy-based fall prevention intervention (STEADI-Rx'],"['DBI scores', 'fall risk', 'Risk of falling', 'risk of falling']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1955953', 'cui_str': 'Medicare Part D'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0000924', 'cui_str': 'Accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",3437.0,0.0297205,"Risk of falling did not change between the pre- to postintervention period or differ between groups (P = .58).
","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Blalock', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Stefanie P', 'Initials': 'SP', 'LastName': 'Ferreri', 'Affiliation': 'Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Chelsea P', 'Initials': 'CP', 'LastName': 'Renfro', 'Affiliation': 'Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center College of Pharmacy, Memphis, Tennessee, USA.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Division of Practice Advancement and Clinical Education, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Joel F', 'Initials': 'JF', 'LastName': 'Farley', 'Affiliation': 'Department of Pharmaceutical Care & Health Systems, University of Minnesota College of Pharmacy, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Neepa', 'Initials': 'N', 'LastName': 'Ray', 'Affiliation': 'University of North Carolina, Eshelman School of Pharmacy, Center for Medication Optimization Through Practice and Policy, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busby-Whitehead', 'Affiliation': 'Division of Geriatric Medicine and Center of Aging and Health, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16459']
137,32310850,Safety and efficacy study of prourokinase injection during primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction.,"OBJECTIVES
To evaluate the efficacy and safety of intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions in patients with acute ST-segment elevation myocardial infarction.
METHODS
Acute ST-segment elevation myocardial infarction patients underwent primary percutaneous coronary interventions were randomly divided into two groups: intracoronary prourokinase group (n = 125) and control group (n = 135). During primary percutaneous coronary interventions, prourokinase or saline was injected to the distal end of the culprit lesion via balloon catheter after balloon catheter dilatation. Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions were evaluated and compared between two groups. Hemorrhagic complications and major averse cardiovascular events (MACE) occurred in the 6-months follow-up were recorded.
RESULTS
No significant differences were observed between two groups with respect to baseline demographic, clinical, and thrombolysis in myocardial infarction grade (P > 0.05). In the intracoronary prourokinase group, more patients had ST-segment resolution (>50%) compared with control group (P < 0.05). Patients in the intracoronary prourokinase group showed lower levels of serum CK, creatine kinase-MB fraction, and troponin I than those in control group (P < 0.05). No significant differences in bleeding complications were observed between the two groups (P > 0.05). At 6-months follow-up, there was no statistically different of MACE between the two groups (P > 0.05).
CONCLUSIONS
Intracoronary administration of prourokinase via balloon catheter during primary percutaneous coronary interventions effectively improved myocardial perfusion and no increased bleeding in ST-segment elevation myocardial infarction patients.",2021,"Patients in the intracoronary prourokinase group showed lower levels of serum CK, creatine kinase-MB fraction, and troponin","['Acute ST-segment elevation myocardial infarction patients underwent primary percutaneous coronary interventions', 'acute ST-segment elevation myocardial infarction', 'patients with acute ST-segment elevation myocardial infarction']","['prourokinase or saline', 'prourokinase injection', 'prourokinase via balloon catheter', 'intracoronary prourokinase']","['ST-segment resolution', 'Demographic and clinical characteristics, infarct size, myocardial reperfusion, and cardiac functions', 'Hemorrhagic complications and major averse cardiovascular events (MACE', 'bleeding', 'lower levels of serum CK, creatine kinase-MB fraction, and troponin', 'baseline demographic, clinical, and thrombolysis in myocardial infarction grade', 'efficacy and safety', 'myocardial perfusion', 'bleeding complications']","[{'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}]","[{'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0027054', 'cui_str': 'Reperfusion, Myocardial'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0233496', 'cui_str': 'Aversion'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}]",135.0,0.019056,"Patients in the intracoronary prourokinase group showed lower levels of serum CK, creatine kinase-MB fraction, and troponin","[{'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Cardiovascular, Shenzhen Yantian People's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiaoshuan', 'Initials': 'X', 'LastName': 'Xiong', 'Affiliation': ''}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Fangzhou', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': ''}]",Coronary artery disease,['10.1097/MCA.0000000000000898']
138,32139381,Efficacy and Safety of Liraglutide 3.0 mg in Individuals With Overweight or Obesity and Type 2 Diabetes Treated With Basal Insulin: The SCALE Insulin Randomized Controlled Trial.,"OBJECTIVE
Most individuals with type 2 diabetes also have obesity, and treatment with some diabetes medications, including insulin, can cause further weight gain. No approved chronic weight management medications have been prospectively investigated in individuals with overweight or obesity and insulin-treated type 2 diabetes. The primary objective of this study was to assess the effect of liraglutide 3.0 mg versus placebo on weight loss in this population.
RESEARCH DESIGN AND METHODS
Satiety and Clinical Adiposity-Liraglutide Evidence (SCALE) Insulin was a 56-week, randomized, double-blind, placebo-controlled, multinational, multicenter trial in individuals with overweight or obesity and type 2 diabetes treated with basal insulin and ≤2 oral antidiabetic drugs.
RESULTS
Individuals were randomized to liraglutide 3.0 mg ( n = 198) or placebo ( n = 198), combined with intensive behavioral therapy (IBT). At 56 weeks, mean weight change was -5.8% for liraglutide 3.0 mg versus -1.5% with placebo (estimated treatment difference -4.3% [95% CI -5.5; -3.2]; P < 0.0001). With liraglutide 3.0 mg, 51.8% of individuals achieved ≥5% weight loss versus 24.0% with placebo (odds ratio 3.41 [95% CI 2.19; 5.31]; P < 0.0001). Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA 1c and mean daytime glucose values and less need for insulin versus placebo, despite a treat-to-glycemic-target protocol. More hypoglycemic events were observed with placebo than liraglutide 3.0 mg. No new safety or tolerability issues were observed.
CONCLUSIONS
In individuals with overweight or obesity and insulin-treated type 2 diabetes, liraglutide 3.0 mg as an adjunct to IBT was superior to placebo regarding weight loss and improved glycemic control despite lower doses of basal insulin and without increases in hypoglycemic events.",2020,"Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA 1c , mean daytime glucose values, and less need for insulin versus placebo, despite a treat-to-glycemic target protocol.","['individuals with overweight or obesity and insulin-treated type 2 diabetes', 'individuals with overweight or obesity and type 2 diabetes treated with basal insulin and less than or equal to two oral antidiabetic drugs', 'individuals with type 2 diabetes', 'Individuals With Overweight or Obesity and Type']","['Liraglutide', 'Basal Insulin', 'placebo', 'intensive behavioral therapy (IBT', 'liraglutide']","['weight loss', 'mean weight change', 'hypoglycemic events', 'weight loss and improved glycemic control', '≥5% weight loss', 'Efficacy and Safety', 'mean HbA 1c , mean daytime glucose values']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.311179,"Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA 1c , mean daytime glucose values, and less need for insulin versus placebo, despite a treat-to-glycemic target protocol.","[{'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, The University of Alabama at Birmingham and the Birmingham VA Medical Center, Birmingham, AL garveyt@uab.edu.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Department of Diabetology, Endocrinology, and Nephrology, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Internal Medicine D, Hasharon Hospital, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Geltrude', 'Initials': 'G', 'LastName': 'Mingrone', 'Affiliation': ""Division of Diabetes and Nutritional Sciences, Faculty of Life Sciences and Medicine, King's College London, London, U.K.""}, {'ForeName': 'Sue D', 'Initials': 'SD', 'LastName': 'Pedersen', 'Affiliation': 'C-ENDO Diabetes and Endocrinology Clinic, Calgary, Alberta, Canada.'}, {'ForeName': 'Altynai', 'Initials': 'A', 'LastName': 'Satylganova', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Skovgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Sugimoto', 'Affiliation': 'Cedar Crosse Research Center, Chicago, IL.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Department of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}]",Diabetes care,['10.2337/dc19-1745']
139,32316070,"Efficacy and safety of ixekizumab in a phase III, randomized, double-blind, placebo-controlled study in paediatric patients with moderate-to-severe plaque psoriasis (IXORA-PEDS).","BACKGROUND
Plaque psoriasis affects children and adults, but treatment options for paediatric psoriasis are limited.
OBJECTIVES
To evaluate the efficacy and safety of ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, for moderate-to-severe paediatric psoriasis.
METHODS
In a randomized, double-blind, placebo-controlled, phase III study (IXORA-PEDS), patients aged 6 to < 18 years with moderate-to-severe plaque psoriasis were randomized 2 : 1 to weight-based dosing of IXE every 4 weeks (IXE Q4W, n = 115) or placebo (n = 56) through week 12, followed by open-label IXE Q4W. Coprimary endpoints were the proportions of patients at week 12 achieving ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) and those achieving a static Physician's Global Assessment score of 0 or 1 (sPGA 0,1).
RESULTS
IXE was superior (P < 0·001) to placebo for both coprimary endpoints of PASI 75 (IXE Q4W, 89%; placebo, 25%) and sPGA (0,1) (IXE Q4W, 81%; placebo, 11%). IXE was also superior for all gated secondary endpoints, including PASI 75 and sPGA (0,1) at week 4, improvement in itch, and complete skin clearance. IXE Q4W provided significant (P < 0·001) improvements vs. placebo in quality of life and clearance of scalp and genital psoriasis. Responses at week 12 were sustained or further improved through week 48. Through week 12, 45% (placebo) and 56% (IXE) of patients reported treatment-emergent adverse events. One serious adverse event was reported (IXE), one patient discontinued due to an adverse event (placebo) and no deaths were reported.
CONCLUSIONS
IXE was superior to placebo in the treatment of moderate-to-severe paediatric psoriasis, and the safety profile was generally consistent with that observed in adults. What is already known about this topic? Paediatric psoriasis affects approximately 1% of children and can negatively impact health-related quality of life. Treatment options for paediatric psoriasis are typically limited to off-label treatments and approved systemic biologics. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin-17A, is approved for moderate-to-severe plaque psoriasis in adults and was recently approved by the US Food and Drug Administration for moderate-to-severe paediatric psoriasis. What does this study add? Ixekizumab resulted in rapid and statistically significant improvements over placebo in skin involvement, itch and health-related quality of life, which persisted through 48 weeks of treatment in paediatric patients with moderate-to-severe plaque psoriasis. The safety profile of ixekizumab was generally consistent with that seen in adults. Ixekizumab may be an additional potential therapeutic option and an additional class of biologic therapy (interleukin-17A antagonist) for the treatment of moderate-to-severe paediatric psoriasis. Plain language summary available online.",2020,IXE Q4W provided significant (p<0·001) improvements versus placebo in quality of life and clearance of scalp and genital psoriasis.,"['patients (age 6 to <18 years) with moderate-to-severe plaque psoriasis', 'Paediatric Patients with Moderate-to-Severe Plaque Psoriasis (IXORA-PEDS']","['IXE', 'IXE every four weeks (IXE Q4W, N=115) or placebo', 'placebo', 'ixekizumab (IXE', 'Ixekizumab', 'Placebo']","['quality of life and clearance of scalp and genital psoriasis', 'safety profile', 'Efficacy and Safety', 'PASI 75 and sPGA (0,1) at Week 4, improvement in itch, and complete skin clearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",,0.383156,IXE Q4W provided significant (p<0·001) improvements versus placebo in quality of life and clearance of scalp and genital psoriasis.,"[{'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'M M B', 'Initials': 'MMB', 'LastName': 'Seyger', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Alejandro Magariños', 'Affiliation': 'Psoriahue, Buenos Aires, Argentina.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cather', 'Affiliation': 'Mindful Dermatology and Modern Research Associates, Dallas, TX, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Keller', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rodriguez Capriles', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gontijo Lima', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Little', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Edson-Heredia', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.19147']
140,32144165,Increase in Endogenous Glucose Production With SGLT2 Inhibition Is Unchanged by Renal Denervation and Correlates Strongly With the Increase in Urinary Glucose Excretion.,"OBJECTIVE
Sodium-glucose cotransporter 2 (SGLT2) inhibition causes an increase in endogenous glucose production (EGP). However, the mechanisms are unclear. We studied the effect of SGLT2 inhibitors on EGP in subjects with type 2 diabetes (T2D) and without diabetes (non-DM) in kidney transplant recipients with renal denervation.
RESEARCH DESIGN AND METHODS
Fourteen subjects who received a renal transplant (six with T2D [A1C 7.2 ± 0.1%] and eight non-DM [A1C 5.6 ± 0.1%) underwent measurement of EGP with [3- 3 H]glucose infusion following dapagliflozin (DAPA) 10 mg or placebo. Plasma glucose, insulin, C-peptide, glucagon, and titrated glucose-specific activity were measured.
RESULTS
Following placebo in T2D, fasting plasma glucose (FPG) (143 ± 14 to 124 ± 10 mg/dL; P = 0.02) and fasting plasma insulin (12 ± 2 to 10 ± 1.1 μU/mL; P < 0.05) decreased; plasma glucagon was unchanged, and EGP declined. After DAPA in T2D, FPG (143 ± 15 to 112 ± 9 mg/dL; P = 0.01) and fasting plasma insulin (14 ± 3 to 11 ± 2 μU/mL; P = 0.02) decreased, and plasma glucagon increased (all P < 0.05 vs. placebo). EGP was unchanged from baseline (2.21 ± 0.19 vs. 1.96 ± 0.14 mg/kg/min) in T2D ( P < 0.001 vs. placebo). In non-DM following DAPA, FPG and fasting plasma insulin decreased, and plasma glucagon was unchanged. EGP was unchanged from baseline (1.85 ± 0.10 to 1.78 ± 0.10 mg/kg/min) after DAPA, whereas EGP declined significantly with placebo. When the increase in EGP production following DAPA versus placebo was plotted against the difference in urinary glucose excretion (UGE) for all patients, a strong correlation ( r = 0.824; P < 0.001) was observed.
CONCLUSIONS
Renal denervation in patients who received a kidney transplant failed to block the DAPA-mediated stimulation of EGP in both individuals with T2D and non-DM subjects. The DAPA-stimulated rise in EGP is strongly related to the increase in UGE, blunting the decline in FPG.",2020,EGP was unchanged from baseline (2.21 ± 0.19 vs. 1.96 ± 0.14 mg/kg/min) in T2D ( P < 0.001 vs. placebo).,"['subjects with type 2 diabetes (T2D) and without diabetes (non-DM) in kidney transplant recipients with renal denervation', 'Fourteen subjects who received a renal transplant (six with T2D [A1C 7.2 ± 0.1%] and eight non-DM [A1C 5.6 ± 0.1%) underwent measurement of']","['SGLT2 inhibitors', 'placebo', 'SGLT2', 'EGP with [3- 3 H]glucose infusion following dapagliflozin (DAPA) 10 mg or placebo', 'Sodium-glucose cotransporter 2']","['Urinary Glucose Excretion', ' plasma glucagon', 'Plasma glucose, insulin, C-peptide, glucagon, and titrated glucose-specific activity', 'urinary glucose excretion (UGE', 'plasma glucagon', 'endogenous glucose production (EGP', 'EGP', 'T2D, fasting plasma glucose (FPG', 'EGP production', 'Endogenous Glucose Production', 'fasting plasma insulin', 'DAPA, FPG and fasting plasma insulin decreased, and plasma glucagon']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",14.0,0.0856011,EGP was unchanged from baseline (2.21 ± 0.19 vs. 1.96 ± 0.14 mg/kg/min) in T2D ( P < 0.001 vs. placebo).,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Solis-Herrera', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Alatrach', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Agyin', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Gastaldelli', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Honka', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Stephano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Section of Diabetes and Metabolic Disease, Department of Clinical and Experimental Medicine, University of Pisa and Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, The University of Texas Health Science Center at San Antonio, San Antonio, TX albarado@uthscsa.edu.'}]",Diabetes care,['10.2337/dc19-2177']
141,32144166,Dalcetrapib Reduces Risk of New-Onset Diabetes in Patients With Coronary Heart Disease.,"OBJECTIVE
Incident type 2 diabetes is common among patients with recent acute coronary syndrome and is associated with an adverse prognosis. Some data suggest that cholesteryl ester transfer protein (CETP) inhibitors reduce incident type 2 diabetes. We compared the effect of treatment with the CETP inhibitor dalcetrapib or placebo on incident diabetes in patients with recent acute coronary syndrome.
RESEARCH DESIGN AND METHODS
In the dal-OUTCOMES trial, 15,871 patients were randomly assigned to treatment with dalcetrapib 600 mg daily or placebo, beginning 4-12 weeks after an acute coronary syndrome. Absence of diabetes at baseline was based on medical history, no use of antihyperglycemic medication, and hemoglobin A 1c and serum glucose levels below diagnostic thresholds. Among these patients, incident diabetes after randomization was defined by any diabetes-related adverse event, new use of antihyperglycemic medication, hemoglobin A 1c ≥6.5%, or a combination of at least two measurements of serum glucose ≥7.0 mmol/L (fasting) or ≥11.1 mmol/L (random).
RESULTS
At baseline, 10,645 patients (67% of the trial cohort) did not have diabetes. During a median follow-up of 30 months, incident diabetes was identified in 403 of 5,326 patients (7.6%) assigned to dalcetrapib and in 516 of 5,319 (9.7%) assigned to placebo, corresponding to absolute risk reduction of 2.1%, hazard ratio of 0.77 (95% CI 0.68-0.88; P < 0.001), and a need to treat 40 patients for 3 years to prevent 1 incident case of diabetes. Considering only those with prediabetes at baseline, the number needed to treat for 3 years to prevent 1 incident case of diabetes was 25. Dalcetrapib also decreased the number of patients who progressed from normoglycemia to prediabetes and increased the number who regressed from diabetes to no diabetes.
CONCLUSIONS
In patients with a recent acute coronary syndrome, incident diabetes is common and is reduced substantially by treatment with dalcetrapib.",2020,"Dalcetrapib also decreased the number of patients who progressed from normoglycemia to prediabetes and increased the number who regressed from diabetes to no diabetes.
","['10,645 patients (67% of the trial cohort) did not have diabetes', 'Patients With Coronary Heart Disease', '15,871 patients', 'patients with recent acute coronary syndrome']","['dalcetrapib', 'Dalcetrapib', 'CETP inhibitor dalcetrapib or placebo', 'placebo', 'cholesteryl ester transfer protein (CETP) inhibitors']",['incident diabetes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C2713495', 'cui_str': 'S-(2-((1-(2-ethylbutyl)cyclohexane)carbonylamino)phenyl) 2-methylpropanethioate'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0055538', 'cui_str': 'Cholesterol Ester Transport Protein, CETP'}]",[],15871.0,0.109939,"Dalcetrapib also decreased the number of patients who progressed from normoglycemia to prediabetes and increased the number who regressed from diabetes to no diabetes.
","[{'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Cardiology Section, Veterans Affairs Medical Center, and University of Colorado School of Medicine, Aurora, CO gregory.schwartz@va.gov.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Christie M', 'Initials': 'CM', 'LastName': 'Ballantyne', 'Affiliation': 'Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Barter', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Black', 'Affiliation': 'DalCor Pharmaceuticals, Zug, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kallend', 'Affiliation': 'The Medicines Company, Zurich, Switzerland.'}, {'ForeName': 'Fouzia', 'Initials': 'F', 'LastName': 'Laghrissi-Thode', 'Affiliation': 'DalCor Pharmaceuticals, Zug, Switzerland.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Leitersdorf', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, Scotland, U.K.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University, Melbourne, Australia.'}, {'ForeName': 'Anders G', 'Initials': 'AG', 'LastName': 'Olsson', 'Affiliation': 'Linköping University, Linköping, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Preiss', 'Affiliation': 'Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Prediman K', 'Initials': 'PK', 'LastName': 'Shah', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, CA.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kittelson', 'Affiliation': 'University of Colorado School of Public Health, Aurora, CO.'}]",Diabetes care,['10.2337/dc19-2204']
142,32315435,Randomized and Controlled Clinical Trial of Bone Healing After Alveolar Ridge Preservation Using Xenografts and Allografts Versus Plasma Rich in Growth Factors.,"The aim of this study was to compare bone regeneration in the anterior maxilla between bone substitutes and autologous platelet concentrate in alveolar ridge preservation. Forty patients requiring tooth extraction in the anterior maxilla were randomly allocated to the following 4 treatment modalities: spontaneous healing (control), natural bovine bone mineral covered with resorbable native collagen membrane (BBM/CM), freeze-dried bone allograft covered with resorbable native collagen membrane (FDBA/CM), and plasma rich in growth factors (PRGF) alone. Bone biopsies and histomorphometrical analysis were performed after 3 months of healing. The following parameters were assessed: newly formed mineralized tissue, newly formed nonmineralized tissue, and residual bone-grafting material (if applicable). Statistical analysis was performed to provide descriptive analysis and to compare the parameters of the bone regeneration between the study groups. Histomorphometrical analysis revealed the highest new mineralized tissue formation in the PRGF group. Statistically significant differences in new mineralized tissue formation were found between control/PRGF (46.4% ± 15.2% vs 75.5% ± 16.3%), control/(BBM/CM) (46.4% ± 15.2% vs 20.3% ± 21.9%), control/(FDBA/CM) (46.4% ± 15.2% vs 7.2% ± 8.6%), PRGF/(BBM/CM) (75.5% ± 16.3% vs 20.3% ± 21.9%), and PRGF/(FDBA/CM) (75.5% ± 16.3% vs 7.2% ± 8.6%) groups. The new mineralized tissue formation was in the following order: PRGF > control > BBM > FDBA. Alveolar ridge preservation in the esthetic zone with PRGF was the most effective for bone regeneration of the alveolar ridge.",2020,"Statistically significant differences in new mineralized tissue formation were found between control/PRGF (46.4±15.2% vs 75.5±16.3%), control/(BBM/CM) (46.4±15.2% vs 20.3±21.9%), control/(FDBA/CM) (46.4±15.2% vs 7.2±8.6), PRGF/(BBM/CM)","['Forty patients requiring tooth extraction in anterior maxilla', 'alveolar ridge preservation']","['xenografts and allografts vs. plasma rich', 'spontaneous healing (control), natural bovine bone mineral covered with resorbable native collagen membrane (BBM/CM), freeze-dried bone allograft covered with resorbable native collagen membrane (FDBA/CM) and Plasma Rich in Growth Factors alone (PRGF']","['PRGF/(BBM/CM', 'control/(BBM/CM', 'new mineralized tissue formation', 'bone regeneration', 'control/(FDBA/CM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0459697', 'cui_str': 'Anterior segment of maxilla'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}]","[{'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0016698', 'cui_str': 'Lyophilization'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0356655,"Statistically significant differences in new mineralized tissue formation were found between control/PRGF (46.4±15.2% vs 75.5±16.3%), control/(BBM/CM) (46.4±15.2% vs 20.3±21.9%), control/(FDBA/CM) (46.4±15.2% vs 7.2±8.6), PRGF/(BBM/CM)","[{'ForeName': 'Arturas', 'Initials': 'A', 'LastName': 'Stumbras', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Gintaras', 'Initials': 'G', 'LastName': 'Januzis', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Albinas', 'Initials': 'A', 'LastName': 'Gervickas', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Ricardas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Gintaras', 'Initials': 'G', 'LastName': 'Juodzbalys', 'Affiliation': 'Department of Maxillofacial Surgery, Faculty of Odontology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00179']
143,31634738,A randomized noninferiority trial evaluating remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT.,"This trial examined whether a stepped care program for depression, which initiated treatment with internet cognitive behavioral therapy, including telephone and messaging support, and stepped up non-responders to telephone-administered cognitive behavioral therapy (tCBT), was noninferior, less costly to deliver, and as acceptable to patients compared to tCBT alone. Adults with a diagnosis of major depressive episode (MDE) were randomized to receive up to 20 weeks of stepped care or tCBT. Stepped care (n = 134) was noninferior to tCBT (n = 136) with an end-of-treatment effect size of d = 0.03 and a 6-month post-treatment effect size of d = -0.07 [90% CI 0.29 to 0.14]. Therapist time in stepped care was 5.26 (SD = 3.08) hours versus 10.16 (SD 4.01) for tCBT (p < 0.0001), with a delivery cost difference of $-364.32 [95% CI $-423.68 to $-304.96]. There was no significant difference in pre-treatment preferences (p = 0.10) or treatment dropout (39 in stepped care; 27 in tCBT; p = 0.14). tCBT patients were significantly more satisfied than stepped care patients with the treatment they received (p < 0.0001). These findings indicate that stepped care was less costly to deliver, but no less effective than tCBT. There was no significant difference in treatment preference or completion, however satisfaction with treatment was higher in tCBT than stepped care. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01906476.",2019,"There was no significant difference in treatment preference or completion, however satisfaction with treatment was higher in tCBT than stepped care.",['Adults with a diagnosis of major depressive episode (MDE'],"['stepped care or tCBT', 'remotely-delivered stepped care for depression using internet cognitive behavioral therapy (CBT) and telephone CBT', 'tCBT', 'internet cognitive behavioral therapy, including telephone and messaging support, and stepped up non-responders to telephone-administered cognitive behavioral therapy (tCBT']","['treatment preference or completion, however satisfaction', 'pre-treatment preferences', 'Therapist time in stepped care']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",,0.11087,"There was no significant difference in treatment preference or completion, however satisfaction with treatment was higher in tCBT than stepped care.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Department of Preventive Medicine, Center for Behavioral Intervention Technologies, Northwestern University, 750 N. Lakeshore Dr., 10th Floor, Chicago, IL, 60611, USA. Electronic address: d-mohr@northwestern.edu.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'Lattie', 'Affiliation': 'Department of Preventive Medicine, Center for Behavioral Intervention Technologies, Northwestern University, 750 N. Lakeshore Dr., 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Kathryn Noth', 'Initials': 'KN', 'LastName': 'Tomasino', 'Affiliation': 'Department of Medicine, Northwestern University, NMH/Arkes Family Pavilion, Suite 1400, 676 N. Saint Clair St., Chicago, IL, 60611, USA.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Department of Preventive Medicine, Center for Behavioral Intervention Technologies, Northwestern University, 750 N. Lakeshore Dr., 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Department of Preventive Medicine, Center for Behavioral Intervention Technologies, Northwestern University, 750 N. Lakeshore Dr., 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Gray', 'Affiliation': 'Department of Preventive Medicine, Center for Behavioral Intervention Technologies, Northwestern University, 750 N. Lakeshore Dr., 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Nameyeh', 'Initials': 'N', 'LastName': 'Alam', 'Affiliation': 'Department of Preventive Medicine, Center for Behavioral Intervention Technologies, Northwestern University, 750 N. Lakeshore Dr., 10th Floor, Chicago, IL, 60611, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Mental Health Services & Policy Program, Northwestern University Feinberg School of Medicine, 710 N Lake Shore Dr, 12th Flr, Chicago, IL, 60611, USA; Center of Innovation for Complex Chronic Healthcare, Hines VA Hospital, 5000 S 5th Ave., Hines, IL, 60141, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Schueller', 'Affiliation': 'Department of Preventive Medicine, Center for Behavioral Intervention Technologies, Northwestern University, 750 N. Lakeshore Dr., 10th Floor, Chicago, IL, 60611, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103485']
144,32108022,Medication Adherence During Adjunct Therapy With Statins and ACE Inhibitors in Adolescents With Type 1 Diabetes.,"OBJECTIVE
Suboptimal adherence to insulin treatment is a main issue in adolescents with type 1 diabetes. However, to date, there are no available data on adherence to adjunct noninsulin medications in this population. Our aim was to assess adherence to ACE inhibitors and statins and explore potential determinants in adolescents with type 1 diabetes.
RESEARCH DESIGN AND METHODS
There were 443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs-an ACE inhibitor and a statin-as well as combinations of both or placebo for 2-4 years. Adherence was assessed every 3 months with the Medication Event Monitoring System (MEMS) and pill count.
RESULTS
Median adherence during the trial was 80.2% (interquartile range 63.6-91.8) based on MEMS and 85.7% (72.4-92.9) for pill count. Adherence based on MEMS and pill count dropped from 92.9% and 96.3%, respectively, at the first visit to 76.3% and 79.0% at the end of the trial. The percentage of study participants with adherence ≥75% declined from 84% to 53%. A good correlation was found between adherence based on MEMS and pill count ( r = 0.82, P < 0.001). Factors associated with adherence were age, glycemic control, and country.
CONCLUSIONS
We report an overall good adherence to ACE inhibitors and statins during a clinical trial, although there was a clear decline in adherence over time. Older age and suboptimal glycemic control at baseline predicted lower adherence during the trial, and, predictably, reduced adherence was more prevalent in subjects who subsequently dropped out.",2020,"RESULTS
Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","['Adolescents With Type 1 Diabetes', 'adolescents with type 1 diabetes', '443 adolescents with type 1 diabetes recruited into the Adolescent Type 1 Diabetes Cardio-renal Intervention Trial (AdDIT) and exposed to treatment with two oral drugs']","['placebo', 'Statins and ACE Inhibitors']","['Adherence based on MEMS and pill count', 'Adherence', 'adherence based on MEMS and pill count', 'Median adherence', 'Medication Adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",443.0,0.0573073,"RESULTS
Median adherence during the trial was 80.2% (interquartile range 63.6-91.8), based on MEMS, and 85.7% (72.4-92.9) for pill count.","[{'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Niechciał', 'Affiliation': 'Department of Pediatric Diabetes, Endocrinology and Obesity, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Carlo L', 'Initials': 'CL', 'LastName': 'Acerini', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Chiesa', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, U.K.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Stevens', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'R Neil', 'Initials': 'RN', 'LastName': 'Dalton', 'Affiliation': ""Evelina Children's Hospital, Guy's and St Thomas' National Health Service Foundation Trust, London, U.K.""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Daneman', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Deanfield', 'Affiliation': 'Institute of Cardiovascular Science, University College London, London, U.K.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Jones', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Farid H', 'Initials': 'FH', 'LastName': 'Mahmud', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sally M', 'Initials': 'SM', 'LastName': 'Marshall', 'Affiliation': 'Institute of Cellular Medicine (Diabetes), Faculty of Clinical Medical Sciences, Newcastle University, Newcastle upon Tyne, U.K.'}, {'ForeName': 'H Andrew W', 'Initials': 'HAW', 'LastName': 'Neil', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology & Metabolism, University of Oxford, Oxford, U.K.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Dunger', 'Affiliation': 'Department of Paediatrics, University of Cambridge, Cambridge, U.K.'}, {'ForeName': 'M Loredana', 'Initials': 'ML', 'LastName': 'Marcovecchio', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0884']
145,32276301,"A double-blind, randomized, placebo-controlled trial of adjunctive blue-blocking glasses for the treatment of sleep and circadian rhythm in patients with bipolar disorder.","OBJECTIVES
Recent studies have suggested that evening blue light exposure is associated with sleep and circadian rhythm abnormalities. This study examined the effect of blue-blocking (BB) glasses on sleep and circadian rhythm in patients with bipolar disorder (BD).
METHODS
We used a randomized, placebo-controlled, double-blinded design. Outpatients with BD and also with insomnia were randomly assigned to wear either orange glasses (BB) or clear ones (placebo) and were instructed to use these from 20:00 hours until bedtime for 2 weeks. The primary outcome metric was the difference in change from baseline to after intervention in sleep quality, as measured by the visual analog scale (VAS).
RESULTS
Forty-three patients were included in this study (BB group, 21; placebo group, 22). The change in sleep quality as per the VAS metric was not significantly different between the two groups (95% confidence interval [CI], -3.34 to 24.72; P = .13). However, the Morningness-Eveningness Questionnaire score had shifted to an advanced rhythm in the BB group and to a delayed rhythm in the placebo group, and the difference in these changes was statistically significant (95% CI, 1.69-7.45; P = .003). The change in the actigraphy sleep parameters and mood symptoms was not significantly different between the two groups.
CONCLUSION
Although concurrent medications may have influenced, our results suggest that BB glasses may be useful as an adjunctive treatment for circadian rhythm issues in patients with BD.",2020,"The change in sleep quality as per the VAS metric was not significantly different between the two groups (95% confidence interval [CI], -3.34 to 24.72; P = 0.13).","['Forty-three patients were included in this study (BB group, 21; placebo group, 22', 'Outpatients with BD and also with insomnia', 'patients with BD', 'patients with bipolar disorder (BD', 'patients with bipolar disorder']","['adjunctive blue-blocking glasses', 'blue-blocking (BB) glasses', 'orange glasses (BB) or clear ones (placebo', 'placebo']","['sleep and circadian rhythm', 'advanced rhythm', 'sleep quality, as measured by the visual analog scale (VAS', 'VAS metric', 'actigraphy sleep parameters and mood symptoms', 'sleep quality', 'Morningness-Eveningness Questionnaire score']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",43.0,0.607403,"The change in sleep quality as per the VAS metric was not significantly different between the two groups (95% confidence interval [CI], -3.34 to 24.72; P = 0.13).","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Esaki', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Ipei', 'Initials': 'I', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Soji', 'Initials': 'S', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Department of Psychiatry, Okehazama Hospital, Toyoake, Aichi, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kitajima', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Aichi, Japan.'}]",Bipolar disorders,['10.1111/bdi.12912']
146,32165444,Intrahepatic Fat and Postprandial Glycemia Increase After Consumption of a Diet Enriched in Saturated Fat Compared With Free Sugars.,"OBJECTIVE
Debate continues regarding the influence of dietary fats and sugars on the risk of developing metabolic diseases, including insulin resistance and nonalcoholic fatty liver disease (NAFLD). We investigated the effect of two eucaloric diets, one enriched with saturated fat (SFA) and the other enriched with free sugars (SUGAR), on intrahepatic triacylglycerol (IHTAG) content, hepatic de novo lipogenesis (DNL), and whole-body postprandial metabolism in overweight males.
RESEARCH DESIGN AND METHODS
Sixteen overweight males were randomized to consume the SFA or SUGAR diet for 4 weeks before consuming the alternate diet after a 7-week washout period. The metabolic effects of the respective diets on IHTAG content, hepatic DNL, and whole-body metabolism were investigated using imaging techniques and metabolic substrates labeled with stable-isotope tracers.
RESULTS
Consumption of the SFA diet significantly increased IHTAG by mean ± SEM 39.0 ± 10.0%, while after the SUGAR diet IHTAG was virtually unchanged. Consumption of the SFA diet induced an exaggerated postprandial glucose and insulin response to a standardized test meal compared with SUGAR. Although whole-body fat oxidation, lipolysis, and DNL were similar following the two diets, consumption of the SUGAR diet resulted in significant ( P < 0.05) decreases in plasma total, HDL, and non-HDL cholesterol and fasting β-hydroxybutyrate plasma concentrations.
CONCLUSIONS
Consumption of an SFA diet had a potent effect, increasing IHTAG together with exaggerating postprandial glycemia. The SUGAR diet did not influence IHTAG and induced minor metabolic changes. Our findings indicate that a diet enriched in SFA is more harmful to metabolic health than a diet enriched in free sugars.",2020,Consumption of the SFA diet induced an exaggerated postprandial glucose and insulin response to a standardized test meal compared with SUGAR.,"['Sixteen overweight males', 'overweight males']","['SFA or SUGAR diet', 'eucaloric diets, one enriched with saturated fat (SFA) and the other enriched with free sugars (SUGAR']","['plasma total, HDL, and non-HDL cholesterol and fasting β-hydroxybutyrate plasma concentrations', 'IHTAG content, hepatic DNL, and whole-body metabolism', 'exaggerated postprandial glucose and insulin response', 'Intrahepatic Fat and Postprandial Glycemia Increase', 'intrahepatic triacylglycerol (IHTAG) content, hepatic de novo lipogenesis (DNL']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1563744', 'cui_str': 'Lipogenesis'}]",16.0,0.0155907,Consumption of the SFA diet induced an exaggerated postprandial glucose and insulin response to a standardized test meal compared with SUGAR.,"[{'ForeName': 'Siôn A', 'Initials': 'SA', 'LastName': 'Parry', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Rosqvist', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Ferenc E', 'Initials': 'FE', 'LastName': 'Mozes', 'Affiliation': 'Oxford Centre for Clinical Magnetic Resonance Research, University of Oxford, John Radcliffe Hospital, Oxford, U.K.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Piche', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Hülsmeier', 'Affiliation': 'Institute for Clinical Chemistry, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Hornemann', 'Affiliation': 'Institute for Clinical Chemistry, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Dyson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, Oxford, U.K. leanne.hodson@ocdem.ox.ac.uk.'}]",Diabetes care,['10.2337/dc19-2331']
147,32307836,School-based targeted prevention compared to specialist mental health treatment for youth anxiety.,"BACKGROUND
The 'FRIENDS for life' program (FRIENDS) is a 10-session cognitive behavioral therapy (CBT) program used for prevention and treatment of youth anxiety. There is discussion about whether FRIENDS is best applied as prevention or as treatment.
METHODS
We compared FRIENDS delivered in schools as targeted prevention to a previous specialist mental health clinic trial. The targeted prevention sample (N = 82; M age = 11.6 years, SD = 2.1; 75.0% girls) was identified and recruited by school nurses in collaboration with a community psychologist. The clinical sample (N = 88, M age = 11.7 years, SD = 2.1; 54.5% girls) was recruited for a randomized controlled trial from community child- and adolescent psychiatric outpatient clinics and was diagnosed with anxiety disorders.
RESULTS
Both samples showed significantly reduced anxiety symptoms from baseline to postintervention, with medium mean effect sizes across raters (youths and parents) and timepoints (post; 12-months follow-up). Baseline youth-reported anxiety symptom levels were similar between the samples, whereas parent-reported youth anxiety was higher in the clinical sample.
CONCLUSIONS
The study suggests that self-reported anxiety levels may not differ between youth recruited in schools and in clinic settings. The results indicate promising results of the FRIENDS program when delivered in schools by less specialized health personnel from the school health services, as well as when delivered in clinics by trained mental health professionals.",2020,"The results indicate promising results of the FRIENDS program when delivered in schools by less specialized health personnel from the school health services, as well as when delivered in clinics by trained mental health professionals.","['The targeted prevention sample (N\xa0=\xa082; M age \xa0=\xa011.6\xa0years, SD\xa0=\xa02.1; 75.0% girls) was identified and recruited by school nurses in collaboration with a community psychologist', 'years, SD\xa0=\xa02.1; 54.5% girls) was recruited for a randomized controlled trial from community child- and adolescent psychiatric outpatient clinics and was diagnosed with anxiety disorders', 'The clinical sample (N\xa0=\xa088, M age \xa0=\xa011.7', 'youth anxiety']","['School-based targeted prevention compared to specialist mental health treatment', 'cognitive behavioral therapy (CBT) program']","['anxiety symptom levels', 'anxiety levels', 'anxiety symptoms', 'youth anxiety']","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0439216,"The results indicate promising results of the FRIENDS program when delivered in schools by less specialized health personnel from the school health services, as well as when delivered in clinics by trained mental health professionals.","[{'ForeName': 'Krister W', 'Initials': 'KW', 'LastName': 'Fjermestad', 'Affiliation': 'Department of Psychology, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Gro Janne', 'Initials': 'GJ', 'LastName': 'Wergeland', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Chile Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Rogde', 'Affiliation': 'Fjell Municipality, Straume, Norway.'}, {'ForeName': 'Jon F', 'Initials': 'JF', 'LastName': 'Bjaastad', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Chile Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Heiervang', 'Affiliation': 'Department of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Bente Storm Mowatt', 'Initials': 'BSM', 'LastName': 'Haugland', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Chile Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}]",Child and adolescent mental health,['10.1111/camh.12366']
148,32213316,Population pharmacokinetics of colistin and the relation to survival in critically ill patients infected with colistin susceptible and carbapenem-resistant bacteria.,"OBJECTIVES
The aim was to analyse the population pharmacokinetics of colistin and to explore the relationship between colistin exposure and time to death.
METHODS
Patients included in the AIDA randomized controlled trial were treated with colistin for severe infections caused by carbapenem-resistant Gram-negative bacteria. All subjects received a 9 million units (MU) loading dose, followed by a 4.5 MU twice daily maintenance dose, with dose reduction if creatinine clearance (CrCL) < 50 mL/min. Individual colistin exposures were estimated from the developed population pharmacokinetic model and an optimized two-sample per patient sampling design. Time to death was evaluated in a parametric survival analysis.
RESULTS
Out of 406 randomized patients, 349 contributed pharmacokinetic data. The median (90% range) colistin plasma concentration was 0.44 (0.14-1.59) mg/L at 15 minutes after the end of first infusion. In samples drawn 10 hr after a maintenance dose, concentrations were >2 mg/L in 94% (195/208) and 44% (38/87) of patients with CrCL ≤120 mL/min, and >120 mL/min, respectively. Colistin methanesulfonate sodium (CMS) and colistin clearances were strongly dependent on CrCL. High colistin exposure to MIC ratio was associated with increased hazard of death in the multivariate analysis (adjusted hazard ratio (95% CI): 1.07 (1.03-1.12)). Other significant predictors included SOFA score at baseline (HR 1.24 (1.19-1.30) per score increase), age and Acinetobacter or Pseudomonas as index pathogen.
DISCUSSION
The population pharmacokinetic model predicted that >90% of the patients had colistin concentrations >2 mg/L at steady state, but only 66% at 4 hr after start of treatment. High colistin exposure was associated with poor kidney function, and was not related to a prolonged survival.",2020,"High colistin exposure to MIC ratio was associated with increased hazard of death in the multivariate analysis [adjusted hazard ratio (95%CI): 1.07 [1.03, 1.12]].","['406 randomized patients, 349 contributed pharmacokinetic data', 'critically ill patients infected with colistin susceptible and carbapenem-resistant bacteria', 'Patients']","['colistin', 'carbapenem-resistant Gram-negative bacteria']","['poor kidney function', 'SOFA score', 'Time-to-death', 'colistin plasma concentration', 'creatinine clearance (CrCL', 'CMS and colistin clearances', 'hazard of death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C3656682', 'cui_str': 'Carbapenem resistant bacteria'}]","[{'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0006968', 'cui_str': 'Antibiotics, Carbapenem'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0018150', 'cui_str': 'Gram-Negative Bacteria'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",406.0,0.103372,"High colistin exposure to MIC ratio was associated with increased hazard of death in the multivariate analysis [adjusted hazard ratio (95%CI): 1.07 [1.03, 1.12]].","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Kristoffersson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Rognås', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'M J E', 'Initials': 'MJE', 'LastName': 'Brill', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Dishon-Benattar', 'Affiliation': 'Institute of Infectious Diseases, Rambam Health Care Campus, Haifa, Israel; The Cheryl Spencer Institute for Nursing Research, University of Haifa, Israel.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Durante-Mangoni', 'Affiliation': ""Department of Precision Medicine, University of Campania 'L Vanvitelli' and AORN dei Colli-Monaldi Hospital, Napoli, Italy.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Daitch', 'Affiliation': 'Infectious Diseases University Research Centre, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel-Aviv University, and Department of Medicine E, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Skiada', 'Affiliation': 'First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lellouche', 'Affiliation': 'National Centre for Infection Control and Antibiotic Resistance, Tel Aviv Medical Centre, Tel Aviv, Israel; National Laboratory for Antibiotic Resistance and Investigation of Outbreaks in Medical Institutions, Tel Aviv Medical Centre, Tel Aviv, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nutman', 'Affiliation': 'National Centre for Infection Control and Antibiotic Resistance, Tel Aviv Medical Centre, Tel Aviv, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kotsaki', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, School of Medicine, University General Hospital Attikon, Athens, Greece.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Andini', 'Affiliation': ""Department of Precision Medicine, University of Campania 'L Vanvitelli' and AORN dei Colli-Monaldi Hospital, Napoli, Italy.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Eliakim-Raz', 'Affiliation': 'Infectious Diseases University Research Centre, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel-Aviv University, and Department of Medicine E, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bitterman', 'Affiliation': 'Institute of Infectious Diseases, Rambam Health Care Campus, Haifa, Israel; The Ruth and Bruce Rappaport Faculty of Medicine, Techion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Antoniadou', 'Affiliation': '4th Department of Internal Medicine, National and Kapodistrian University of Athens, School of Medicine, University General Hospital Attikon, Athens, Greece.'}, {'ForeName': 'M O', 'Initials': 'MO', 'LastName': 'Karlsson', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Theuretzbacher', 'Affiliation': 'Centre for Anti-Infective Agents, Vienna, Austria.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Leibovici', 'Affiliation': 'Sackler Faculty of Medicine, Tel-Aviv University, and Department of Medicine E, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel; Department of Medicine E, Rabin Medical Centre, Beilinson Hospital, Petah Tikva, Israel.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Daikos', 'Affiliation': 'First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Carmeli', 'Affiliation': 'National Centre for Infection Control and Antibiotic Resistance, Tel Aviv Medical Centre, Tel Aviv, Israel; National Laboratory for Antibiotic Resistance and Investigation of Outbreaks in Medical Institutions, Tel Aviv Medical Centre, Tel Aviv, Israel.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Institute of Infectious Diseases, Rambam Health Care Campus, Haifa, Israel; The Ruth and Bruce Rappaport Faculty of Medicine, Techion - Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Friberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. Electronic address: lena.friberg@farmbio.uu.se.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.03.016']
149,32305099,"Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial.","BACKGROUND
State-of-the art therapy for recurrent ovarian cancer suitable for platinum-based re-treatment includes bevacizumab-containing combinations (eg, bevacizumab combined with carboplatin-paclitaxel or carboplatin-gemcitabine) or the most active non-bevacizumab regimen: carboplatin-pegylated liposomal doxorubicin. The aim of this head-to-head trial was to compare a standard bevacizumab-containing regimen versus carboplatin-pegylated liposomal doxorubicin combined with bevacizumab.
METHODS
This multicentre, open-label, randomised, phase 3 trial, was done in 159 academic centres in Germany, France, Australia, Austria, and the UK. Eligible patients (aged ≥18 years) had histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with first disease recurrence more than 6 months after first-line platinum-based chemotherapy, and an Eastern Cooperative Oncology Group performance status of 0-2. Patients were stratified by platinum-free interval, residual tumour, previous antiangiogenic therapy, and study group language, and were centrally randomly assigned 1:1 using randomly permuted blocks of size two, four, or six to receive six intravenous cycles of bevacizumab (15 mg/kg, day 1) plus carboplatin (area under the concentration curve [AUC] 4, day 1) plus gemcitabine (1000 mg/m 2 , days 1 and 8) every 3 weeks or six cycles of bevacizumab (10 mg/kg, days 1 and 15) plus carboplatin (AUC 5, day 1) plus pegylated liposomal doxorubicin (30 mg/m 2 , day 1) every 4 weeks, both followed by maintenance bevacizumab (15 mg/kg every 3 weeks in both groups) until disease progression or unacceptable toxicity. There was no masking in this open-label trial. The primary endpoint was investigator-assessed progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1. Efficacy data were analysed in the intention-to-treat population. Safety was analysed in all patients who received at least one dose of study drug. This completed study is registered with ClinicalTrials.gov, NCT01837251.
FINDINGS
Between Aug 1, 2013, and July 31, 2015, 682 eligible patients were enrolled, of whom 345 were randomly assigned to receive carboplatin-pegylated liposomal doxorubicin-bevacizumab (experimental group) and 337 were randomly assigned to receive carboplatin-gemcitabine-bevacizumab (standard group). Median follow-up for progression-free survival at data cutoff (July 10, 2018) was 12·4 months (IQR 8·3-21·7) in the experimental group and 11·3 months (8·0-18·4) in the standard group. Median progression-free survival was 13·3 months (95% CI 11·7-14·2) in the experimental group versus 11·6 months (11·0-12·7) in the standard group (hazard ratio 0·81, 95% CI 0·68-0·96; p=0·012). The most common grade 3 or 4 adverse events were hypertension (88 [27%] of 332 patients in the experimental group vs 67 [20%] of 329 patients in the standard group) and neutropenia (40 [12%] vs 73 [22%]). Serious adverse events occurred in 33 (10%) of 332 patients in the experimental group and 28 (9%) of 329 in the standard group. Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage).
INTERPRETATION
Carboplatin-pegylated liposomal doxorubicin-bevacizumab is a new standard treatment option for platinum-eligible recurrent ovarian cancer.
FUNDING
F Hoffmann-La Roche.",2020,"Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage).
","['Patients were stratified by platinum-free interval, residual tumour, previous antiangiogenic therapy, and study group language', '159 academic centres in Germany, France, Australia, Austria, and the UK', 'Between Aug 1, 2013, and July 31, 2015', '682 eligible patients were enrolled, of whom 345', 'recurrent ovarian cancer', 'platinum-eligible recurrent ovarian cancer', 'Eligible patients (aged ≥18 years) had histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with first disease recurrence more than 6 months after first-line platinum-based chemotherapy, and an Eastern Cooperative Oncology Group performance status of 0-2']","['doxorubicin ', 'Carboplatin-pegylated liposomal doxorubicin-bevacizumab', 'carboplatin-pegylated liposomal doxorubicin-bevacizumab', 'gemcitabine', 'carboplatin', 'bevacizumab regimen: carboplatin-pegylated liposomal doxorubicin', 'bevacizumab', 'Bevacizumab and platinum-based combinations', 'carboplatin-gemcitabine-bevacizumab', 'bevacizumab-containing combinations (eg, bevacizumab combined with carboplatin-paclitaxel or carboplatin-gemcitabine', 'standard bevacizumab-containing regimen versus carboplatin-pegylated liposomal doxorubicin combined with bevacizumab', 'carboplatin (AUC 5, day 1) plus pegylated liposomal']","['large intestine perforation', 'osmotic demyelination syndrome and intracranial haemorrhage', 'Safety', 'neutropenia', 'Serious adverse events', 'deaths', 'Median progression-free survival', 'investigator-assessed progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0238122', 'cui_str': 'Carcinoma of fallopian tube'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}]","[{'cui': 'C0151738', 'cui_str': 'Perforation of large intestine'}, {'cui': 'C2721559', 'cui_str': 'Osmotic demyelination syndrome'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]",682.0,0.197238,"Treatment-related deaths occurred in one patient in the experimental group (<1%; large intestine perforation) and two patients in the standard group (1%; one case each of osmotic demyelination syndrome and intracranial haemorrhage).
","[{'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Pfisterer', 'Affiliation': 'Gynaecologic Oncology Center, Kiel, Germany. Electronic address: jacobus.pfisterer@googlemail.com.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Shannon', 'Affiliation': 'Oncology Department, Mater Cancer Care Centre, Brisbane, QLD, Australia.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Baumann', 'Affiliation': 'Gynaecology Department, Klinikum der Stadt Ludwigshafen am Rhein, Ludwigshafen, Germany.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Rau', 'Affiliation': 'Coordinating Center for Clinical Trials, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Gynaecology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Department of Gynaecology, and European Competence Center for Ovarian Cancer, Charité - Universitätsmedizin Berlin, Campus Virchow, Berlin, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Canzler', 'Affiliation': 'Department of Gynaecology, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': 'Technical University of Munich-Klinikum Rechts der Isar, Germany; Department of Gynaecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Dean', 'Affiliation': 'Gynaecological Oncology Department, St John of God Hospital, Subiaco, WA, Australia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hein', 'Affiliation': 'Gynaecology Department, Erlangen University Hospital, Erlangen, Germany.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Zeimet', 'Affiliation': 'Department of Obstetrics and Gynaecology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Lars C', 'Initials': 'LC', 'LastName': 'Hanker', 'Affiliation': 'Gynaecology Department, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Petit', 'Affiliation': 'Paul Strauss Cancer Center and Gynaecology Department, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Gynaecology Department, National Center for Tumor Disease, University of Heidelberg, Heidelberg, Germany; Department of Gynaecology and Obstetrics, University Hospital Mannheim, Mannheim, Germany.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'El-Balat', 'Affiliation': 'Department of Gynaecology and Obstetrics, University of Frankfurt/Main, Frankfurt, Germany.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Glasspool', 'Affiliation': 'National Cancer Research Institute, Beatson West of Scotland Cancer Centre and University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'de Gregorio', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'Department of Gynaecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Obstetrics and Gynaecology, University Hospital, Ludwig-Maximilian-University, Munich, Germany.'}, {'ForeName': 'Tarek M', 'Initials': 'TM', 'LastName': 'Meniawy', 'Affiliation': 'Department of Medical Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Tjoung-Won', 'Initials': 'TW', 'LastName': 'Park-Simon', 'Affiliation': 'Department of Gynaecology and Obstetrics, Medical University Hannover, Hannover, Germany.'}, {'ForeName': 'Marie-Ange', 'Initials': 'MA', 'LastName': 'Mouret-Reynier', 'Affiliation': 'Department of Medical Oncology, Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Costan', 'Affiliation': 'Department of Oncology, Hôpital Michallon, Grenoble, France.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Meier', 'Affiliation': 'Department of Gynaecology and Obstetrics, Evangelisches Krankenhaus Düsseldorf, Germany; Department of Gynaecology and Obstetrics, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology, Comprehensive Cancer Centre, University Hospital for Gynaecology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane & Women's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Tifenn', 'Initials': 'T', 'LastName': ""L'Haridon"", 'Affiliation': 'Centre Hospitalier Départemental les Oudairies, La Roche-Sur-Yon, France.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Baron Hay', 'Affiliation': ""Women's Health, Royal North Shore Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kommoss', 'Affiliation': ""Department of Women's Health, Tübingen University Hospital, Tübingen, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Kliniken Essen-Mitte, Essen, Germany.'}, {'ForeName': 'Jean-Emmanuel', 'Initials': 'JE', 'LastName': 'Kurtz', 'Affiliation': 'Haematology-Oncology Department, Centre Hospitalier Régional et Universitaire de Strasbourg Hôpital Civil, Strasbourg, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30142-X']
150,31675437,Inhibitory Effects of Probenecid on Pharmacokinetics of Tenofovir Disoproxil Fumarate and Emtricitabine for On-Demand HIV Preexposure Prophylaxis.,"In a randomized, crossover pharmacokinetic study in healthy volunteers (N = 14), a single dose of 2 g probenecid (PRO)-boosted 600 mg tenofovir disoproxil fumarate (TDF)/400 mg emtricitabine (FTC) (test (T) +PRO) was compared with the current on-demand HIV preexposure prophylaxis from the IPERGAY study (a 600 mg TDF/400 mg FTC on day 1 and 300 mg TDF/200 mg FTC on days 2 and 3) (control, C IPERGAY). PRO increased mean single-dose area under the plasma concentration-time curve extrapolated to infinity (AUC 0-∞,SD ) of tenofovir (TFV) and FTC by 61% and 68%, respectively. The TFV-diphosphate (TFV-DP) concentrations in peripheral blood mononuclear cells were higher (~30%) at 24 hours in T +PRO but then fell significantly lower (~40%) at 72 hours compared with C IPERGAY. The interaction between FTC and PRO was unexpected and novel. Further study is needed to determine if this PRO-boosted TDF/FTC regimen would be clinically effective.",2020,"PRO increased mean single dose plasma AUC 0-∞,SD of TFV and FTC by 61% and 68%, respectively.",['healthy volunteers (N=14'],"['probenecid (PRO)-boosted 600 mg tenofovir disoproxil fumarate (TDF) / 400 mg emtricitabine (FTC) (Treatment, T +PRO', 'Tenofovir Disoproxil Fumarate and Emtricitabine', 'Probenecid', 'TDF/200 mg FTC']","['PRO increased mean single dose plasma AUC 0-∞,SD of TFV and FTC', 'TFV-diphosphate (TFV-DP) concentrations in peripheral blood mononuclear cells (PBMC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033209', 'cui_str': 'Probenecid'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0034320', 'cui_str': 'Pyrophosphates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",,0.0383763,"PRO increased mean single dose plasma AUC 0-∞,SD of TFV and FTC by 61% and 68%, respectively.","[{'ForeName': 'Stephanie N', 'Initials': 'SN', 'LastName': 'Liu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Brandon T', 'Initials': 'BT', 'LastName': 'Gufford', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jessica Bo Li', 'Initials': 'JBL', 'LastName': 'Lu', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lane R', 'Initials': 'LR', 'LastName': 'Bushman', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Anderson', 'Affiliation': 'Department of Pharmaceutical Sciences, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, Colorado, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Bergstrom', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, School of Medicine, Indiana University, Indianapolis, Indiana, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1714']
151,31562118,Visual benefit versus visual gain: what is the effect of baseline covariants in the treatment arm relative to the control arm? A pooled analysis of ANCHOR and MARINA.,"BACKGROUND
This study aimed to elucidate visual benefits of ranibizumab in patients with neovascular age-related macular degeneration (nAMD) compared with control arms and identify factors affecting response.
METHODS
This is a post-hoc pooled analysis of two phase III studies, ANCHOR and MARINA, of ranibizumab for the treatment of nAMD. ANCHOR included 83 international sites. MARINA included 96 sites in the USA. Analysis included patients (control, n=323; ranibizumab, n=332) with nAMD and a baseline best-corrected visual acuity (BCVA) of ≥35-<85 letters.
RESULTS
Patients receiving ranibizumab achieved an adjusted mean BCVA superiority of 18.9 and 21.2 letters over 12 and 24 months, respectively, compared with control. Ranibizumab treatment, higher baseline BCVA, lower age and smaller lesion size were positively associated with the ability to achieve BCVA >69 letters. Patients with the highest baseline BCVA had lowest BCVA gains. Ranibizumab treatment, lower baseline BCVA, lower age and smaller lesion size were identified as significant predictors of BCVA gain from baseline at month 24 (all p<0.0001). However, the difference in mean BCVA gains at month 24 between treatment and control groups was similar for all baseline BCVA subgroups (≥35-<55 letters, 21.9 letters; ≥55-<70 letters, 25.2 letters; ≥70-<85 letters, 19.3 letters).
CONCLUSIONS
Higher baseline BCVA is associated with lower BCVA gains but a greater likelihood of achieving good final BCVA >69 letters due to smaller gains needed to achieve response. Visual benefits, including maintenance of visual acuity (VA), final VA achieved and relative gain compared with natural disease progression, should be considered when assessing treatment response in nAMD.",2020,"Ranibizumab treatment, lower baseline BCVA, lower age and smaller lesion size were identified as significant predictors of BCVA gain from baseline at month 24 (all p<0.0001).","['patients with neovascular age-related macular degeneration (nAMD', 'Analysis included patients (control, n=323; ranibizumab, n=332) with nAMD and a baseline best-corrected visual acuity (BCVA) of ≥35-<85 letters']","['ranibizumab', 'Ranibizumab', 'Visual benefit versus visual gain']","['BCVA gains', 'lower baseline BCVA, lower age and smaller lesion size', 'higher baseline BCVA, lower age and smaller lesion size', 'mean BCVA superiority', 'Visual benefits, including maintenance of visual acuity (VA', 'BCVA gain', 'lowest BCVA gains', 'mean BCVA gains']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",69.0,0.150313,"Ranibizumab treatment, lower baseline BCVA, lower age and smaller lesion size were identified as significant predictors of BCVA gain from baseline at month 24 (all p<0.0001).","[{'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Tufail', 'Affiliation': 'Medical Retina, Moorfields Eye Hospital & Institute of Ophthalmology UCL, London, UK adnan.tufail@moorfields.nhs.uk.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Margaron', 'Affiliation': 'Novartis Pharma, Basel, Switzerland.'}, {'ForeName': 'Tadhg', 'Initials': 'T', 'LastName': 'Guerin', 'Affiliation': 'Theravance Biopharma, Dublin, Ireland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Larsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet & Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313682']
152,32310156,The effects of dry needling on pain relief and functional balance in patients with sub-chronic low back pain.,"BACKGROUND
Pain relief is important both for the movement of patients suffering from low back pain and the quality of life. Dry needling is effective on myofascial trigger points but its effect on the area of pain and the functional balance is not fully known.
OBJECTIVE
To examine the immediate effect of dry needling on pain and functional balance of patients suffering from low back pain.
METHODS
Twenty five patients with sub-chronic low back pain were randomly divided into two groups: the intervention or control group. Needles were used for the participants of the intervention group, bilaterally at the spinus level, one and a half finger breath from the midline in levels L2-L5 of the lumbar spine. A third line of needles was inserted in the interspinosus spaces, except L5-S1 level. Bipedal stance, lateral loading and mediolateral body sway were assessed using a pair of force plates. Pain tolerance was assessed using an algometer.
RESULTS
The pain tolerance significantly increased in the intervention group from (M = 4.87, SE 0.663) to (M = 6.52, SE 0.547) (F(1,23) = 7.8, p< 0.05) after intervention. During mediolateral body sway the force signal in the dominant frequency significantly increased in the intervention group from (M = 43.2, SE 4.6) to (M = 54,9, SE 3.6) (F(1,23) = 4.63, p< 0.05) after intervention, exhibiting more controlled rhythmic behavior.
CONCLUSIONS
Dry needling in painful areas and penetrating all the muscle groups seems to improve pain and functional balance, yet its effect on specific muscles needs to be studied further.",2020,"The pain tolerance significantly increased in the intervention group from (M = 4.87, SE 0.663) to (M = 6.52, SE 0.547) (F(1,23) = 7.8, p< 0.05) after intervention.","['Twenty five patients with sub-chronic low back pain', 'patients suffering from low back pain', 'patients with sub-chronic low back pain']","['Dry needling', 'dry needling']","['Pain tolerance', 'pain and functional balance', 'Bipedal stance, lateral loading and mediolateral body sway', 'pain tolerance', 'pain relief and functional balance']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",25.0,0.0283228,"The pain tolerance significantly increased in the intervention group from (M = 4.87, SE 0.663) to (M = 6.52, SE 0.547) (F(1,23) = 7.8, p< 0.05) after intervention.","[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Loizidis', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Saint Loukes Hospital, Panorama, Thessaloniki, Greece.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Nikodelis', 'Affiliation': 'Biomechanics Laboratory, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'El', 'Initials': 'E', 'LastName': 'Bakas', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Rehabilitation Center Euromedica Arogi, Thessaloniki, Greece.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kollias', 'Affiliation': 'Biomechanics Laboratory, Department of Physical Education and Sport Science, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181265']
153,32310158,Lumbosacral immobilization following glucocorticoid intradiscal injection in patients with chronic low back pain and active discopathy: A feasibility study.,"BACKGROUND
In people with chronic low back pain (cLBP) and active discopathy, glucocorticoid intradiscal injection (GC IDI) reduces LBP in the short-term. Lumbosacral immobilization may be useful to obtain long-term results.
OBJECTIVE
To assess the feasibility of a lumbosacral immobilization using a pantaloon cast following GC IDI in people with cLBP sand active discopathy.
METHODS
We conducted a retrospective feasibility study. Participants were allocated to experimental or control groups by preferences. The experimental group received lumbosacral immobilization using a custom-made pantaloon cast worn continuously for one week following a GC IDI of 25 mg of prednisolone acetate. The control group received GC IDI alone. The primary endpoint was the feasibility of lumbosacral immobilization assessed by the rate of refusal and early withdrawal of the cast.
RESULTS
Twelve patients were offered lumbosacral immobilization following GC IDI: the rate of refusal was 3/12 (25.0%) and was 3/9 (33.3%) of early withdrawal. Mean (95% CI) acceptability of the procedure was 55.0 (26.9-83.1)/100 in the experimental group (N= 6) and 61.6 (25.1-98.2)/100 in the control group (N= 6).
CONCLUSIONS
We found high rates of refusal and early withdrawal of the lumbosacral immobilization using a pantaloon cast following GC IDI in people with nonspecific cLBP and active discopathy.",2020,"The primary endpoint was the feasibility of lumbosacral immobilization assessed by the rate of refusal and early withdrawal of the cast.
","['people with chronic low back pain (cLBP', 'patients with chronic low back pain and active discopathy', 'people with cLBP sand active discopathy', 'people with nonspecific cLBP and active discopathy']","['lumbosacral immobilization', 'lumbosacral immobilization using a pantaloon cast following GC IDI', 'glucocorticoid intradiscal injection', 'glucocorticoid intradiscal injection (GC IDI', 'pantaloon cast following GC IDI', 'prednisolone acetate', 'GC IDI alone']","['rate of refusal', 'feasibility of lumbosacral immobilization assessed by the rate of refusal and early withdrawal of the cast']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2747858', 'cui_str': 'Discopathy'}, {'cui': 'C4759711', 'cui_str': 'Sand'}]","[{'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C1512934', 'cui_str': 'Intradiscal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}]","[{'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0179686', 'cui_str': 'Cast'}]",12.0,0.103024,"The primary endpoint was the feasibility of lumbosacral immobilization assessed by the rate of refusal and early withdrawal of the cast.
","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Couzi', 'Affiliation': 'Université Paris Descartes, Faculté de Médecine, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Boisson', 'Affiliation': ""AP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Segretin', 'Affiliation': ""AP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.""}, {'ForeName': 'Marie-Martine', 'Initials': 'MM', 'LastName': 'Lefèvre-Colau', 'Affiliation': 'Université Paris Descartes, Faculté de Médecine, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roren', 'Affiliation': 'Université Paris Descartes, Faculté de Médecine, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Moreau', 'Affiliation': ""AP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Goret', 'Affiliation': ""AP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Université Paris Descartes, Faculté de Médecine, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Rannou', 'Affiliation': 'Université Paris Descartes, Faculté de Médecine, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': 'Université Paris Descartes, Faculté de Médecine, Sorbonne Paris Cité, Paris, France.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191552']
154,31494015,Effectiveness of a Disability Preventive Intervention for Minority and Immigrant Elders: The Positive Minds-Strong Bodies Randomized Clinical Trial.,"OBJECTIVE
To test the acceptability and effectiveness of a disability prevention intervention, Positive Minds-Strong Bodies (PMSB), offered by paraprofessionals to mostly immigrant elders in four languages.
DESIGN
Randomized trial of 307 participants, equally randomized into intervention or enhanced usual care.
SETTING
Community-based organizations in Massachusetts, New York, Florida, and Puerto Rico serving minority elders. Data collected at baseline, 2, 6, and 12 months, between May 2015 and March 2019.
PARTICIPANTS
English-, Spanish-, Mandarin-, or Cantonese-speaking adults, age 60+, not seeking disability prevention services, but eligible per elevated mood symptoms and minor to moderate physical dysfunction.
INTERVENTIONS
Ten individual sessions of cognitive behavioral therapy (PM) concurrently offered with 36 group sessions of strengthening exercise training (SB) over 6 months compared to enhanced usual care.
MEASUREMENTS
Acceptability defined as satisfaction and attendance to >50% of sessions. Effectiveness determined by changes in mood symptoms (HSCL-25 and GAD-7), functional performance (SPPB), self-reported disability (LLFDI), and disability days (WHODAS 2.0).
RESULTS
Around 77.6% of intervention participants attended over half of PM Sessions; 53.4% attended over half of SB sessions. Intent-to-treat analyses at 6 months showed significant intervention effects: improved functioning per SPPB and LLFDI, and lowered mood symptoms per HSCL-25. Intent-to-treat analyses at 12 months showed that effects remained significant for LLFDI and HSCL-25, and disability days (per WHODAS 2.0) significantly decreased 6-month after the intervention.
CONCLUSIONS
PMSB offered by paraprofessionals in community-based organizations demonstrates good acceptability and seems to improve functioning, with a compliance-benefit effect showing compliance as an important determinant of the intervention response.",2019,"Intent-to-treat analyses at 6 months showed significant intervention effects: improved functioning per SPPB and LLFDI, and lowered mood symptoms per HSCL-25.","['English-, Spanish-, Mandarin-, or Cantonese-speaking adults, age 60+, not seeking disability prevention services, but eligible per elevated mood symptoms and minor to moderate physical dysfunction', 'Minority and Immigrant Elders', 'Community-based organizations in Massachusetts, New York, Florida, and Puerto Rico serving minority elders', 'mostly immigrant elders in four languages', '307 participants']","['cognitive behavioral therapy (PM', 'disability prevention intervention, Positive Minds-Strong Bodies (PMSB', 'Disability Preventive Intervention', 'strengthening exercise training (SB', 'intervention or enhanced usual care']","['LLFDI and HSCL-25, and disability days', 'mood symptoms (HSCL-25 and GAD-7), functional performance (SPPB), self-reported disability (LLFDI), and disability days (WHODAS 2.0', 'functioning per SPPB and LLFDI, and lowered mood symptoms per HSCL-25']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0233479', 'cui_str': 'Elevated mood (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0282163', 'cui_str': 'Immigrants'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0023008', 'cui_str': 'Languages'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C3853978'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",307.0,0.0479984,"Intent-to-treat analyses at 6 months showed significant intervention effects: improved functioning per SPPB and LLFDI, and lowered mood symptoms per HSCL-25.","[{'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Alegría', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA; Department of Psychiatry, Harvard Medical School (MA), Boston, MA. Electronic address: malegria@mgh.harvard.edu.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Frontera', 'Affiliation': 'Departments of Physical Medicine, Rehabilitation and Sports Medicine and Physiology and Biophysics, University of Puerto Rico (WF), Río Piedras, Puerto Rico.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cruz-Gonzalez', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Sheri Lapatin', 'Initials': 'SL', 'LastName': 'Markle', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Chau', 'Initials': 'C', 'LastName': 'Trinh-Shevrin', 'Affiliation': 'Department of Population Health, Department of Medicine, New York University School of Medicine (CTS), New York, NY.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Herrera', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Rachel Zack', 'Initials': 'RZ', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital (RZI, GP), Boston, MA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Velazquez', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T. H. Chan School of Public Health (EV), Boston, MA.""}, {'ForeName': 'Larimar', 'Initials': 'L', 'LastName': 'Fuentes', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Psychology, West Chester University of Pennsylvania (JP), West Chester, PA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Cheung', 'Affiliation': 'Greater Boston Chinese Golden Age Center (MC), Boston, MA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Hamilton Madison House (JW), New York, NY.'}, {'ForeName': 'Urania', 'Initials': 'U', 'LastName': 'Genatios', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Jimenez', 'Affiliation': 'Department of Psychology, University of Puerto Rico (AJ), San Juan, Puerto Rico.'}, {'ForeName': 'Zorangelí', 'Initials': 'Z', 'LastName': 'Ramos', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital (RZI, GP), Boston, MA.'}, {'ForeName': 'Josephine Yankau', 'Initials': 'JY', 'LastName': 'Wong', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Ching-King', 'Initials': 'CK', 'LastName': 'Chieng', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital (MA, MCG, SLM, YW, LH, LF, YG, UG, ZR, JYW, CKC), Boston, MA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Bartels', 'Affiliation': 'The Mongan Institute, Massachusetts General Hospital (SJB), Boston, MA.'}, {'ForeName': 'Naihua', 'Initials': 'N', 'LastName': 'Duan', 'Affiliation': 'Department of Psychiatry, Columbia University (ND), New York, NY.'}, {'ForeName': 'Patrick E', 'Initials': 'PE', 'LastName': 'Shrout', 'Affiliation': 'Department of Psychology, New York University (PES), New York, NY.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.08.008']
155,32314038,Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma.,"Health-related quality of life was a secondary endpoint in the phase III GALLIUM study in previously untreated patients with follicular lymphoma who were treated with rituximab- or obinutuzumab-chemotherapy. Patients were randomized 1:1 to receive induction therapy with obinutuzumab- or rituximab-chemotherapy and maintenance in responders. Health-related quality of life was assessed using the Functional Assessment of Cancer Treatment-Lymphoma questionnaire, incorporating well-being and lymphoma-specific subscales. Assessments were performed at baseline, and during induction, maintenance, and follow-up (maximum 84 months). Clinically meaningful responses were defined by minimally important difference values. Of 1202 randomized patients (median follow-up 57.4 months), 557/601 (92.7%; obinutuzumab-chemotherapy) and 548/601 (91.2%; rituximab-chemotherapy) completed all Functional Assessment of Cancer Treatment-Lymphoma scales at baseline. Mean baseline health-related quality of life scores were similar between both arms, with all patients having some functional impairment and lymphoma symptoms. Over the course of treatment, mean health-related quality of life remained similar in both arms. Equal proportions of patients in both arms achieved minimally important difference by the Functional Assessment of Cancer Treatment-Lymphoma lymphoma-specific subscale and summary scales throughout induction, maintenance, and follow-up. On each summary scale, ~ 50% of patients in each arm achieved minimally important difference by maintenance month 2. In GALLIUM, similar improvements in health-related quality of life were seen with obinutuzumab- and rituximab-chemotherapy, suggesting that both treatments reduced lymphoma-related symptoms, and treatment-related side effects did not abrogate these improvements in well-being. ClinicalTrials.gov identifier: NCT01332968.",2020,"Equal proportions of patients in both arms achieved minimally important difference by the Functional Assessment of Cancer Treatment-Lymphoma lymphoma-specific subscale and summary scales throughout induction, maintenance, and follow-up.","['previously untreated patients with follicular lymphoma who were treated with', 'patients with previously untreated advanced follicular lymphoma']","['obinutuzumab- or rituximab-based chemotherapy', 'rituximab- or obinutuzumab-chemotherapy', 'rituximab-chemotherapy', 'induction therapy with obinutuzumab- or rituximab-chemotherapy', 'obinutuzumab-chemotherapy']","['Mean baseline health-related quality of life scores', 'mean health-related quality of life', 'Functional Assessment of Cancer Treatment-Lymphoma lymphoma-specific subscale and summary scales', 'health-related quality of life', 'Health-related quality of life', 'Functional Assessment of Cancer Treatment-Lymphoma scales']","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024299', 'cui_str': 'Malignant lymphoma'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1202.0,0.0315889,"Equal proportions of patients in both arms achieved minimally important difference by the Functional Assessment of Cancer Treatment-Lymphoma lymphoma-specific subscale and summary scales throughout induction, maintenance, and follow-up.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Cancer Research UK Centre, Centre for Cancer Immunology, Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, SO16 6YD, UK. a.davies@southampton.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Demeter', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Florschütz', 'Affiliation': 'Städtisches Klinikum Dessau, Dessau-Roßlau, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hänel', 'Affiliation': 'Klinikum Chemnitz gGmbH, Chemnitz, Germany.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Pettengell', 'Affiliation': ""St George's University, London, UK.""}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne and St. Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'Shalal', 'Initials': 'S', 'LastName': 'Sadullah', 'Affiliation': 'James Paget Hospital, Great Yarmouth, UK.'}, {'ForeName': 'Juan-Manuel', 'Initials': 'JM', 'LastName': 'Sancho', 'Affiliation': 'ICO-IJC-Hospital Germans Trias i Pujol, Barcelona, Spain.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Udvardy', 'Affiliation': 'Medical and Health Science Centre, University of Debrecen, Debrecen, Hungary.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Witzens-Harig', 'Affiliation': 'Uniklinik Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Knapp', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}]",Annals of hematology,['10.1007/s00277-020-04021-6']
156,31663769,Impact of menopausal hormone formulations on pituitary-ovarian regulatory feedback.,"Changes in pituitary-ovarian hormones across the menopausal transition have multiple physiological consequences. However, little is known about how the major types of postmenopausal hormone therapy (HT) affect pituitary-ovarian hormonal relationships. This study evaluated these relationships in recently menopausal women (52.45 ± 2.49 yr of age) in the Kronos Early Estrogen Prevention Study (KEEPS) who were compliant to randomized, double-blinded treatment with oral conjugated equine estrogen (o-CEE; n = 109), transdermal 17β-estradiol (t-E2; n = 107), or placebo ( n = 146). Androstenedione, testosterone, 17β-estradiol, estrone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) were measured in serum before (baseline) and 48 mo after randomization to treatment. Descriptive summaries of hormone levels were performed, and multiple regression analyses were used to examine the effects of o-CEE, t-E2, and placebo on these hormone levels at 48 mo, adjusting for baseline levels. A network analysis examined the covariance of changes in hormone levels over the 48 mo within treatment groups. As expected, at 48 mo of treatment, hormone levels differed between women in the two active treatment groups compared with placebo, and network analysis indicated stronger relationships among hormone levels in the t-E2 and o-CEE groups compared with placebo. Associations among testosterone, 17β-estradiol, FSH, and LH differed between the o-CEE group compared with t-E2 and placebo groups. Thus, two common HT regimens differentially alter pituitary-ovarian hormone levels, altering feedback cycles and interhormonal associations in recently menopausal women. These interactions provide the basis for future studies investigating the impact of hormonal modulation of aging, including cognitive decline in women.",2019,"Associations among testosterone, 17β-estradiol, FSH and LH differed between the o-CEE group compared to t-E2 and placebo groups.","['recently menopausal women (52.45± 2.49 years of age) in the Kronos Early Estrogen Prevention Study (KEEPS', 'women']","['placebo', 'Menopausal Hormone Formulations', 'oral conjugated equine estrogen (o-CEE, n=109), transdermal 17β-estradiol']","['Androstenedione, testosterone, 17β-estradiol, estrone, follicle stimulating hormone (FSH), and luteinizing hormone (LH', 'pituitary-ovarian hormone levels, altering feedback cycles and inter-hormonal associations', 'testosterone, 17β-estradiol, FSH and LH', 'hormone levels']","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4708661', 'cui_str': '2.49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1136013', 'cui_str': 'Conjugated Equine Estrogens'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}]","[{'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C4521988', 'cui_str': 'Ovarian hormone (disposition)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",,0.484776,"Associations among testosterone, 17β-estradiol, FSH and LH differed between the o-CEE group compared to t-E2 and placebo groups.","[{'ForeName': 'Juliana M', 'Initials': 'JM', 'LastName': 'Kling', 'Affiliation': ""Division of Women's Health Internal Medicine, Mayo Clinic, Scottsdale, Arizona.""}, {'ForeName': 'N Maritza', 'Initials': 'NM', 'LastName': 'Dowling', 'Affiliation': 'Department of Acute and Chronic Care, School of Nursing, Department of Epidemiology and Biostatistics, Milken Institute School of Public Health, George Washington University, Washington, D.C.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Bimonte-Nelson', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Carey E', 'Initials': 'CE', 'LastName': 'Gleason', 'Affiliation': ""Division of Geriatrics, Department of Medicine, University of Wisconsin School of Medicine and Public Health and the Wisconsin Alzheimer's Disease Research Center, Madison Veterans Affairs GRECC, Madison, Wisconsin.""}, {'ForeName': 'Kejal', 'Initials': 'K', 'LastName': 'Kantarci', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eliot A', 'Initials': 'EA', 'LastName': 'Brinton', 'Affiliation': 'Utah Lipid Center, Salt Lake City, Utah.'}, {'ForeName': 'Rogerio A', 'Initials': 'RA', 'LastName': 'Lobo', 'Affiliation': 'Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, New York, New York.'}, {'ForeName': 'Marcelle I', 'Initials': 'MI', 'LastName': 'Cedars', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Division of Reproductive Endocrinology and Infertility, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Lubna', 'Initials': 'L', 'LastName': 'Pal', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Neal-Perry', 'Affiliation': 'Division of Reproductive Endocrinology and Infertility, University of Washington, Seattle, Washington.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Naftolin', 'Affiliation': 'Reproductive Biology Research, Department of Obstetrics and Gynecology, New York University, New York, New York.'}, {'ForeName': 'S Mitchell', 'Initials': 'SM', 'LastName': 'Harman', 'Affiliation': 'The Kronos Longevity Research Institute, Phoenix Veterans Affairs Health Care System, University of Arizona College of Medicine, Phoenix, Arizona.'}, {'ForeName': 'Virginia M', 'Initials': 'VM', 'LastName': 'Miller', 'Affiliation': 'Departments of Surgery and Physiology and Biomedical Engineering, Mayo Clinic, Rochester, Minnesota.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00234.2019']
157,31873985,Class effect of xanthine oxidase inhibitors on flow-mediated dilatation in hypertensive patients: A randomized controlled trial.,"A direct comparison of the effects of febuxostat and allopurinol on flow-mediated dilatation (FMD) will help to clarify which agent provides a better reduction of cardiovascular risk in hypertensive patients. Hypertensive patients with hyperuricemia were randomized into a febuxostat (10-40 mg, n = 33) or allopurinol (100-200 mg, n = 31) group and followed up for 6 months. Both the febuxostat (7.9 ± 1.3 mg/dL vs 5.6 ± 1.0 mg/dL, P < .001) and allopurinol (8.2 ± 1.3 mg/dL vs 6.1 ± 1.0 mg/dL, P < .001) groups exhibited significant reductions in uric acid after treatment. There was no significant difference in the change in FMD between the two treatment groups (0.6 ± 2.6% vs 0.2 ± 2.3%, P = .504). However, stratified analysis showed that febuxostat achieved a significantly greater change in FMD compared to allopurinol in the elderly group (1.3 ± 2.9% vs -0.7%±1.8%, P = .047). There was no difference in the improvement of FMD between febuxostat and allopurinol, but febuxostat may provide an improvement of FMD in elderly people.",2020,"There was no difference in the improvement of FMD between febuxostat and allopurinol, but febuxostat may provide an improvement of FMD in elderly people.","['Hypertensive patients with hyperuricemia', 'hypertensive patients']","['xanthine oxidase inhibitors', 'febuxostat', 'febuxostat and allopurinol', 'allopurinol']","['flow-mediated dilatation', 'FMD', 'uric acid']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}]","[{'cui': 'C4521861', 'cui_str': 'Xanthine oxidase inhibitor'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}]",,0.0652437,"There was no difference in the improvement of FMD between febuxostat and allopurinol, but febuxostat may provide an improvement of FMD in elderly people.","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hoshide', 'Affiliation': 'Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Kabutoya', 'Affiliation': 'Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Ueno', 'Affiliation': 'Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13757']
158,31628723,"""I Could Do It in My Own Time and When I Really Needed It"": Perceptions of Online Pain Coping Skills Training For People With Knee Osteoarthritis.","OBJECTIVE
To qualitatively explore the perceptions and experiences of people with knee osteoarthritis (OA) who used an online automated pain coping skills training program (PCST).
METHODS
This was a descriptive qualitative study (based on interpretivist methodology) embedded within a randomized controlled trial. Individual semistructured interviews were conducted with 12 people with knee OA who had participated in an 8-week automated online PCST program while also receiving exercise advice and support from a physical therapist via Skype. Interviews in this study focused specifically on the online PCST program, rather than the physical therapy component. Interviews were audiorecorded, transcribed verbatim, and thematically analyzed.
RESULTS
Five themes arose: 1) easy to understand and follow (clearly explained, presented well), 2) better able to cope with pain (controlling pain, helping relax, pacing self, incorporating skills into exercise program), 3) anonymity and flexibility (no judgement by clinician, work at own pace, accessibility), 4) not always relatable or engaging (some techniques not useful, Americanization of the program, annoying character examples, time consuming and slow-paced), and 5) support from clinician desirable (follow-up from a clinician would be beneficial, worked in tandem with physical therapist-prescribed exercise, desire referral to the program by a trusted source).
CONCLUSION
People with knee OA had generally positive experiences using an online PCST program, suggesting that online PCST is a broadly acceptable and accessible way to help people with OA to manage their pain. User engagement may be enhanced by redesigning some aspects of the program and by provision of support from a clinician.",2020,Individual semi-structured interviews were conducted with 12 people with knee OA who had participated in an 8-week automated online PCST program while also receiving exercise advice and support from a physiotherapist via Skype TM .,"['people with knee osteoarthritis (OA', 'people with knee osteoarthritis', '12 people with knee OA who had participated in an', 'People with knee OA']","['online pain coping skills training', 'online automated pain coping skills training program (PCST', '8-week automated online PCST program while also receiving exercise advice and support from a physiotherapist via Skype TM ', 'always relatable or engaging (some techniques not useful; Americanisation of the program; annoying character examples; time consuming and slow-paced); 5) support from clinician desirable (follow-up from a clinician would be beneficial; worked in tandem with physiotherapist-prescribed exercise; desire referral to the program by trusted source']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]",[],,0.0476341,Individual semi-structured interviews were conducted with 12 people with knee OA who had participated in an 8-week automated online PCST program while also receiving exercise advice and support from a physiotherapist via Skype TM .,"[{'ForeName': 'Belinda J', 'Initials': 'BJ', 'LastName': 'Lawford', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Rana S', 'Initials': 'RS', 'LastName': 'Hinman', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Nelligan', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Keefe', 'Affiliation': 'Duke Medical Center, Durham, North Carolina.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rini', 'Affiliation': 'Hackensack University Medical Center, Hackensack, New Jersey, and Georgetown University School of Medicine, Washington, DC.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'The University of Melbourne, Parkville, Victoria, Australia.'}]",Arthritis care & research,['10.1002/acr.24093']
159,32307842,SafeSpot: an innovative app and mental health support package for Scottish schools - a qualitative analysis as part of a mixed methods study.,"AIMS
The aim of the study was to investigate teachers' and pupils' perceptions about the effect of the SafeSpot mental health curriculum on the well-being of young people and on their knowledge of mental health conditions. This trial intends to determine the acceptability and benefits of web and mobile technology in delivering emotional well-being in schools, through use of the SafeSpot programme.
BACKGROUND
With 10% of young people aged 5 to 16 diagnosed with a mental disorder, there is pressure for schools to address their pupils' emotional well-being. However, many educators report that their schools have insufficient provisions and feel inadequately equipped to support pupils' mental health.
METHODS
This qualitative analysis was embedded within a randomly allocated stepped-wedge design, conducted in six West of Scotland secondary schools. A total of 2320 pupils (aged 11 to 14 years) and 90 teachers were included. Young people's understanding of health-seeking, and teacher's confidence in delivering and accessing well-being information was assessed qualitatively.
RESULTS
Qualitative analysis revealed themes highlighting the beneficial nature of SafeSpot, including pupil engagement, content of tutorials, perceived impact of SafeSpot and level of training provided for teachers.
CONCLUSIONS
Web technology could potentially offer a more structured way for staff to support their pupils' mental health, whilst reducing stigma. SafeSpot was perceived, by pupils and teachers, to be engaging.",2020,"Young people's understanding of health-seeking, and teacher's confidence in delivering and accessing well-being information was assessed qualitatively.
","['2320 pupils (aged 11 to 14\xa0years) and 90 teachers were included', 'young people aged 5 to 16 diagnosed with a mental disorder', 'young people and on their knowledge of mental health conditions']","['SafeSpot mental health curriculum', 'SafeSpot']","['beneficial nature of SafeSpot, including pupil engagement, content of tutorials, perceived impact of SafeSpot and level of training provided for teachers']","[{'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",2320.0,0.146464,"Young people's understanding of health-seeking, and teacher's confidence in delivering and accessing well-being information was assessed qualitatively.
","[{'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Punukollu', 'Affiliation': 'Department of Child and Adolescent Psychiatry, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Leighton', 'Affiliation': 'Department of Psychiatry, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Anna F', 'Initials': 'AF', 'LastName': 'Brooks', 'Affiliation': 'College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Saoirse', 'Initials': 'S', 'LastName': 'Heron', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Mitchell', 'Affiliation': 'Department of Child and Adolescent Psychiatry, NHS Greater Glasgow and Clyde, Glasgow, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Regener', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Karagiorgou', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Bell', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Mhairi', 'Initials': 'M', 'LastName': 'Gilmour', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Nasreen', 'Initials': 'N', 'LastName': 'Moya', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Sharpe', 'Affiliation': 'Department of Clinical and Health Psychology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Minnis', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}]",Child and adolescent mental health,['10.1111/camh.12375']
160,31992538,Residual incompetent tributaries after varicose vein surgery increased the need for reintervention after 8 years.,"OBJECTIVE
The aim of this study was to determine whether residual incompetent tributaries after varicose vein surgery affected the reintervention rate after longer follow-up.
METHODS
The study is a retrospective review of data from a cohort of a previous randomized controlled study comparing surgery with and without preoperative duplex ultrasound, with follow-up after 2 months, 2 years, and 5 to 9 years clinically and with duplex ultrasound. The cohort was subdivided according to the duplex ultrasound findings 2 months after surgery: no venous incompetence, residual incompetent tributaries only, truncal incompetence, and combined truncal and tributary incompetence. Reintervention rates were compared between groups.
RESULTS
There were 280 patients (326 legs) who attended follow-up 2 months postoperatively and 164 patients (190 legs) after a median of 8 years (5-9 years). Another 53 patients (62 legs) were interviewed by telephone or had been reoperated on earlier during follow-up; thus, information was available for 217 patients (252 legs). Of the 252 legs, 56 (22%) were reoperated on during follow-up. In the subgroup with no venous incompetence at all 2 months postoperatively, 4 of 74 legs (5%) were reoperated on; and in the group with residual incompetent tributaries without truncal incompetence, 16 of 56 legs (29%) were reoperated on (P = .000). There was no significant difference in reintervention rate of the group with incompetent tributaries only compared with those with truncal incompetence without incompetent tributaries (12/42 legs [29%]; P = 1) or with combined incompetence of truncal vein and tributaries (22/64 legs [34%]; P = .495). The presence of perforating vein incompetence at 2 months postoperatively did not significantly alter the rate of reoperations (P = .159). In legs that had not been reoperated on, more incompetent veins could be seen progressively. In the group without any incompetent veins postoperatively, 37% still had normal findings at 8 years.
CONCLUSIONS
Residual incompetent tributaries after treatment of varicose veins will increase the reintervention rate in the long term, as much as leaving a trunk vein untreated. Patients should be informed about the increased risk of reintervention if not all incompetent veins are targeted.",2020,The presence of perforating vein incompetence at 2 months postoperatively did not significantly alter the rate of reoperations (P = .159).,"['280 patients (326 legs) who attended follow-up 2\xa0months postoperatively and 164 patients (190 legs) after a median of 8\xa0years (5-9\xa0years', 'Another 53 patients (62 legs) were interviewed by telephone or had been reoperated on earlier during follow-up; thus, information was available for 217 patients (252 legs']","['surgery with and without preoperative duplex ultrasound', 'varicose vein surgery']","['presence of perforating vein incompetence', 'risk of reintervention', 'reintervention rate', 'rate of reoperations', 'Reintervention rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0242845', 'cui_str': 'Ultrasonography, Doppler, Duplex'}, {'cui': 'C0042345', 'cui_str': 'Varices'}]","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}]",,0.0472461,The presence of perforating vein incompetence at 2 months postoperatively did not significantly alter the rate of reoperations (P = .159).,"[{'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Blomgren', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University Hospital, Örebro, Sweden. Electronic address: lena.blomgren@oru.se.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2019.11.012']
161,31420190,Prevalence of anxiety and depression among women with Polycystic Ovary Syndrome living in war versus non-war zone countries: A randomized controlled trial assessing a pharmacist intervention.,"BACKGROUND
Polycystic ovary syndrome (PCOS) is a serious health problem. In women experiencing PCOS, there are myriad physical and mental health consequences; anxiety/depression are commonly associated with this condition. Community pharmacists are in a pivotal position to identify and help women diagnosed with PCOS.
OBJECTIVES
To investigate the prevalence/severity of anxiety/depression among females diagnosed with PCOS living in Syria (a war-zone country) and Jordan (a non-war zone country). Secondly, to evaluate the impact of a pharmaceutical care service delivered by a clinical pharmacist on participants' anxiety/depression severity.
METHODS
Females, diagnosed with PCOS above the age of 16, were recruited into the study and randomly allocated into either the active or the control group. The active group participants received a PCOS pharmaceutical care service. This service involved the provision of verbal and written educational materials, with a special focus on diet and exercise. The control group participants received only standard counseling. Both groups were followed up for four months. All participants completed the Beck Anxiety Inventory and the Beck Depression Inventory at baseline and follow-up.
RESULTS
Data from study participants (n = 118) from both Syria (n = 60) and Jordan (n = 58) highlighted a high prevalence of anxiety (Syria = 95% vs. Jordan = 98%) and depression (Syria = 83% vs. Jordan = 65%). At follow-up, active group participants, from both countries, showed significant improvements in anxiety and depression mean scores (anxiety: Syria = 34.97 ± 14.8 vs. 30.47 ± 14.3, p < 0.001; Jordan = 26.93 ± 13.7 vs. 23.37 ± 15.2, p < 0.001; depression: Syria = 26.53 ± 12.6 vs. 22.93 ± 12.2, p < 0.001; Jordan = 17.70 ± 11.0 vs. 15.76 ± 11.1, p = 0.049). No significant improvements were evident for control group participants from either countries.
CONCLUSION
Prevalence of anxiety/depression for females with PCOS living in Syria and in Jordan is high and calls for special attention by healthcare specialists and policymakers in both countries. Females, who received the PCOS pharmaceutical care service, showed significant improvements in anxiety/depression scores. Improvements were similar in both countries.",2020,"At follow-up, active group participants, from both countries, showed significant improvements in anxiety and depression mean scores (anxiety: Syria = 34.97 ± 14.8 vs. 30.47 ± 14.3, p < 0.001; Jordan = 26.93 ± 13.7 vs. 23.37 ± 15.2, p < 0.001; depression: Syria = 26.53 ± 12.6 vs. 22.93 ± 12.2, p < 0.001; Jordan = 17.70 ± 11.0 vs. 15.76 ± 11.1, p = 0.049).","[""participants' anxiety/depression severity"", 'Females, diagnosed with PCOS above the age of 16', 'females with PCOS living in Syria and in Jordan', 'females diagnosed with PCOS living in Syria (a war-zone country) and Jordan (a non-war zone country', 'women with Polycystic Ovary Syndrome living in war versus non-war zone countries', 'Polycystic ovary syndrome (PCOS']","['standard counseling', 'PCOS pharmaceutical care service']","['anxiety and depression mean scores', 'anxiety and depression', 'Beck Anxiety Inventory and the Beck Depression Inventory', 'anxiety/depression scores']","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0039138', 'cui_str': 'Syria'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1449618', 'cui_str': 'Pharmaceutical Care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",,0.15364,"At follow-up, active group participants, from both countries, showed significant improvements in anxiety and depression mean scores (anxiety: Syria = 34.97 ± 14.8 vs. 30.47 ± 14.3, p < 0.001; Jordan = 26.93 ± 13.7 vs. 23.37 ± 15.2, p < 0.001; depression: Syria = 26.53 ± 12.6 vs. 22.93 ± 12.2, p < 0.001; Jordan = 17.70 ± 11.0 vs. 15.76 ± 11.1, p = 0.049).","[{'ForeName': 'Kinda T', 'Initials': 'KT', 'LastName': 'Alkoudsi', 'Affiliation': 'Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan. Electronic address: Kinda.alkoudsi@gmail.com.'}, {'ForeName': 'Iman A', 'Initials': 'IA', 'LastName': 'Basheti', 'Affiliation': 'Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan. Electronic address: dr_iman@asu.edu.jo.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.08.027']
162,31705526,"Guselkumab is superior to fumaric acid esters in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment: results from a randomized, active-comparator-controlled phase IIIb trial (POLARIS).","BACKGROUND
Guselkumab, a fully human interleukin-23 antibody, is approved for systemic treatment of patients with moderate-to-severe plaque psoriasis.
OBJECTIVES
To compare the efficacy and safety of guselkumab with those of fumaric acid esters (FAE) in patients with moderate-to-severe plaque psoriasis who are naive to systemic treatment.
METHODS
Eligible patients were randomized to this multicentre, randomized, open-label, assessor-blinded, active-comparator-controlled phase IIIb study to receive guselkumab 100 mg by subcutaneous injection or oral FAE according to local label guidelines.
RESULTS
Through week 24, 56 of 60 patients completed guselkumab treatment and 36 of 59 completed FAE treatment. The primary endpoint (proportion of patients with ≥ 90% improvement from their baseline Psoriasis Area and Severity Index; PASI 90 response) was achieved by significantly more patients receiving guselkumab than FAE at week 24 (82% vs. 14%, P < 0·001). Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90% vs. 27%, P < 0·001) and Dermatology Life Quality Index score of 0 or 1 (no effect at all on the patient's quality of life; 62% vs. 17%, P < 0·001). More patients in the guselkumab group achieved completely clear skin (PASI 100 response) than in the FAE group (32% vs. 3%, P < 0·001). The incidence of adverse events was lower with guselkumab than with FAE (73% vs. 98%). Overall, 28% of patients on FAE discontinued due to an adverse event, compared with none receiving guselkumab. No new safety findings were observed for guselkumab.
CONCLUSIONS
Guselkumab demonstrated superiority over FAE in systemic-treatment-naive patients with moderate-to-severe plaque psoriasis through 24 weeks.",2020,"Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90.0% vs. 27.1%, p<0.001) and the Dermatology Life Quality Index (DLQI) response of 0/1 (no effect at all on patient's life; 61.7% vs. 16.9%, p<0.001).","['Eligible patients', 'patients with moderate-to-severe plaque psoriasis', 'systemic treatment-naïve patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis who are naïve to systemic treatment']","['FAE treatment', 'fumaric acid esters', 'Guselkumab', 'oral FAE', 'guselkumab with fumaric acid esters (FAE', 'guselkumab treatment', 'FAE']","['completely clear skin (PASI 100 response', 'PASI 75 response', 'incidence of adverse events (AE', 'baseline Psoriasis Area and Severity Index; PASI\xa090 response', 'Dermatology Life Quality Index (DLQI) response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}]",,0.088747,"Analysis of the major secondary endpoints confirmed a statistically significant difference between the treatments with regards to PASI 75 response (90.0% vs. 27.1%, p<0.001) and the Dermatology Life Quality Index (DLQI) response of 0/1 (no effect at all on patient's life; 61.7% vs. 16.9%, p<0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Centre for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinter', 'Affiliation': 'Department of Dermatology, Venereology and Allergology, University Hospital of Frankfurt am Main, Frankfurt am Main, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Dermatological Practice Dr. med. Michael Sebastian, Mahlow, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Termeer', 'Affiliation': 'Dermatological Practice Prof. Dr. med. Christian Termeer, Stuttgart, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sticherling', 'Affiliation': 'Department of Dermatology, University Hospital of Erlangen, Erlangen, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerdes', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, Venerology and Allergology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wegner', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Krampe', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bartz', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rausch', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mensch', 'Affiliation': 'Janssen-Cilag GmbH, Neuss, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Eyerich', 'Affiliation': 'Department of Dermatology and Allergy, Technical University of Munich, Munich, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18696']
163,32221989,The project REBOOT protocol: Evaluating a personalized inhibitory control training as an adjunct to cognitive behavioral therapy for bulimia nervosa and binge-eating disorder.,"Outcomes from cognitive behavioral therapy (CBT) for bulimia nervosa (BN) and binge-eating disorder (BED) are suboptimal. One potential explanation is that CBT fails to adequately target inhibitory control (i.e., the ability to withhold an automatic response), which is a key maintenance factor for binge eating. Computerized inhibitory control training (ICT) is a promising method for improving inhibitory control but is relatively untested in BN/BED. The present study will evaluate a computer-based ICT as an adjunct to CBT for BN/BED. Participants with BN (n = 30) or BED (n = 30) will be randomized to 12 weeks of either CBT + ICT or CBT + a sham training. Trainings will be completed daily for 4 weeks and weekly for 8 weeks. Primary aims include the following: (a) confirm target engagement (evaluate whether ICT improves inhibitory control), (b) test target validation (evaluate whether improvements in inhibitory control are associated with improvements in binge eating), and (c) evaluate the incremental efficacy of ICT on binge eating. Secondary aims include the following: (a) evaluate ICT feasibility and acceptability and (b) assess the moderating effects of approach tendencies on highly palatable food, dietary restraint, and diagnosis. Data will be used to shape a fully powered clinical trial designed to assess efficacy and dose-response effects of ICT for BN/BED.",2020,Outcomes from cognitive behavioral therapy (CBT) for bulimia nervosa (BN) and binge-eating disorder (BED) are suboptimal.,"['Participants with BN (n = 30) or BED (n = 30', 'bulimia nervosa and binge-eating disorder', 'bulimia nervosa (BN) and binge-eating disorder (BED']","['personalized inhibitory control training', 'cognitive behavioral therapy (CBT', 'Computerized inhibitory control training (ICT', 'cognitive behavioral therapy', 'CBT\u2009+\u2009ICT or CBT\u2009+\u2009a sham training']","['binge eating), and (c) evaluate the incremental efficacy of ICT on binge eating', 'ICT feasibility and acceptability and (b) assess the moderating effects of approach tendencies on highly palatable food, dietary restraint, and diagnosis']","[{'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",30.0,0.043429,Outcomes from cognitive behavioral therapy (CBT) for bulimia nervosa (BN) and binge-eating disorder (BED) are suboptimal.,"[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Lampe', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Gillikin', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Payne-Reichert', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Center for Weight, Eating, and Lifestyle Science, Drexel University, Philadelphia, Pennsylvania.'}]",The International journal of eating disorders,['10.1002/eat.23225']
164,32299097,Maxillary Sinus Floor Elevation Surgery With BioOss Mixed With Enamel Matrix Derivative: A Human Randomized Controlled Clinical and Histologic Study.,"Xenograft bone substitutes are commonly used to increase bone volume and height in the deficient posterior maxilla. The addition of enamel matrix derivate (Emdogain) could increase the efficiency of the bone healing process. The aim of this prospective randomized, controlled split-mouth design study was to compare the percentage of newly formed bone in sinus floor augmentation with deproteinized bovine bone mineral with or without the addition of enamel matrix derivative after 6 months of healing. Sixteen bilateral sinus floor augmentation procedures were performed. Deproteinized bovine bone mineral combined with enamel matrix derivative (test) and deproteinized bovine bone mineral alone (control) groups were randomly allocated within each patient. Six months after augmentation and concurrent to implant placement, bone biopsies were taken for histomorphometric analysis. Additionally, implant survival and peri-implant bone levels were radiographically assessed at baseline and 24 months after functional loading. Histomorphometric analysis revealed a significantly higher amount of newly formed bone in the test group compared with the control group (22.6% and 15.5%, respectively; P = .033). No significant differences in the amount of remaining graft or connective tissue was found. Enamel matrix derivative added to deproteinized bovine bone mineral particles significantly increased new bone formation in sinus lift procedures in edentulous or partially edentulous patients with deficient bilateral posterior alveolar ridges requiring augmentation for implant placement.",2020,Enamel matrix derivative added to deproteinized bovine bone mineral particles significantly increased new bone formation in sinus lift procedures in edentulous or partially edentulous patients with deficient bilateral posterior alveolar ridges requiring augmentation for implant placement.,"['Sixteen bilateral sinus floor augmentation procedures', 'sinus lift procedures in edentulous or partially edentulous patients with deficient bilateral posterior alveolar ridges requiring augmentation for implant placement']","['enamel matrix derivate (Emdogain ® ', 'Deproteinized bovine bone mineral combined with enamel matrix derivative (test) and deproteinized bovine bone mineral alone', 'deproteinized bovine bone mineral with or without the addition of enamel matrix derivative', 'deproteinized bovine bone mineral particles', 'Xenograft bone substitutes']","['amount of remaining graft or connective tissue', 'implant survival and peri-implant bone levels', 'new bone formation']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3178819', 'cui_str': 'Sinus Augmentation Therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0667828', 'cui_str': 'EMDOGAIN'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}]",,0.0378459,Enamel matrix derivative added to deproteinized bovine bone mineral particles significantly increased new bone formation in sinus lift procedures in edentulous or partially edentulous patients with deficient bilateral posterior alveolar ridges requiring augmentation for implant placement.,"[{'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Vincent-Bugnas', 'Affiliation': 'Département de parodontologie, Pôle odontologie, Centre Hospitalier Universitaire de Nice.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Charbit', 'Affiliation': 'Département de parodontologie, Pôle odontologie, Centre Hospitalier Universitaire de Nice.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Charbit', 'Affiliation': 'Département de parodontologie, Pôle odontologie, Centre Hospitalier Universitaire de Nice.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Dard', 'Affiliation': 'Section of Oral, Diagnosis and Rehabilitation Sciences, Columbia University, College of Dental Medicine, New York, New York.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Pippenger', 'Affiliation': 'Preclinical & Translational Research, Institut Straumann AG, Basel, Switzerland.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00119']
165,32266044,A Randomized Controlled Trial of a Mindfulness-Based Weight Loss Intervention on Cardiovascular Reactivity to Social-Evaluative Threat Among Adults with Obesity.,"Objective
Mindfulness-based interventions have been found to reduce psychological and physiological stress reactivity. In obesity, however, stress reactivity is complex, with studies showing both exaggerated and blunted physiological responses to stressors. A nuanced view of stress reactivity is the ""challenge and threat"" framework, which defines adaptive and maladaptive patterns of psychophysiological stress reactivity. We hypothesized that mindfulness training would facilitate increased challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR) compared to a control group, which would exhibit an increased threat pattern of psychophysiological reactivity to repeated stressors.
Methods
Adults (N=194) with obesity were randomized to a 5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines. Participants were assessed at baseline and 4.5 months later using the Trier Social Stress Task. Electrocardiogram, impedance cardiography, and blood pressure were acquired at rest and during the speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity.
Results
Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP. Findings were independent of changes in body mass index.
Conclusions
Mindfulness training may increase the ability to maintain a positive outlook and mount adaptive cardiovascular responses to repeated stressors among persons with obesity though findings need to be replicated in other populations and using other forms of mindfulness interventions.",2019,"Results
Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP.","['persons with obesity', 'Adults with Obesity', 'Methods\n\n\nAdults (N=194) with obesity']","['5.5-month mindfulness-based weight loss intervention or an active control condition with identical diet-exercise guidelines', 'mindfulness training', 'Mindfulness-Based Weight Loss Intervention']","['Electrocardiogram, impedance cardiography, and blood pressure', 'speech and verbal arithmetic tasks to assess pre-ejection period (PEP), CO, and TPR reactivity', 'challenge-related appraisals, emotions, and cardiovascular reactivity, including sympathetic nervous system activation paired with increased cardiac output (CO) and reduced total peripheral resistance (TPR', 'maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007185', 'cui_str': 'Impedance Cardiography'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C1098484', 'cui_str': 'TPR protein, human'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",194.0,0.0190553,"Results
Mindfulness participants showed significantly greater maintenance of challenge-related emotions and cardiovascular reactivity patterns (higher CO and lower TPR) from pre to post-intervention compared to control participants, but groups did not differ in PEP.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Daubenmier', 'Affiliation': 'Institute of Holistic Health Studies, San Francisco State University.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Moran', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'BayView Hunters Point Clinic.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Mason', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Acree', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Goldman', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kristeller', 'Affiliation': 'Department of Psychology, Indiana State University.'}, {'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Hecht', 'Affiliation': 'Department of Medicine, Osher Center for Integrative Medicine.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Mendes', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}]",Mindfulness,['10.1007/s12671-019-01232-5']
166,32273271,A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.,"OBJECTIVE
The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D.
RESEARCH DESIGN AND METHODS
This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c 9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 ( n = 92) or glargine U100 ( n = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70-180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia.
RESULTS
There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%, P > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%, P = 0.023).
CONCLUSIONS
Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.",2020,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74).","['type 2 diabetes (T2D', 'Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial', '176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c 9.5 ± 2.2%), treated with oral agents or insulin before admission', 'noncritically ill patients with T2D.\nMETHODS']","['Glargine U300 and Glargine U100', 'U300 glargine insulin', 'glargine U300 versus glargine', 'glargine U100', 'glargine U300']","['percentage of readings within target BG', 'safety and efficacy', 'rates of clinically significant hypoglycemia', 'length of stay', 'hospital complications', 'occurrence of hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",176.0,0.187812,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74).","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Lansang', 'Affiliation': 'The Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Khowaja', 'Affiliation': 'Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'M Agustina', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Migdal', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA geumpie@emory.edu.'}]",Diabetes care,['10.2337/dc19-1940']
167,32304185,The course of pain intensity and frequency of adolescents treated because of temporomandibular disorders: A long-term follow-up.,"OBJECTIVES
To evaluate the course of pain intensity and frequency related to temporomandibular disorders (TMDs) 15 years (range 5-21 years) after having received TMD treatment as adolescents due to frequent (at least once a week) TMD pain in two controlled trials.
MATERIALS AND METHODS
In the first trial, subjects (n = 122) were randomly allocated to either information only, received in a control condition (Co), or information and an occlusal appliance (OA) versus relaxation therapy (RT). In the second trial, including 64 subjects, nonresponders to OA or RT were subsequently allocated to the alternate treatment (ST). All study participants having completed the trials (n = 167) were invited to a long-term follow-up evaluations, with a response rate of 69.5% (n = 116). Patient-reported outcomes of TMD-related frequency and intensity were appraised relative to baseline data and short-term outcomes as observed in the two trials by use of general linear mixed model and generalized estimation equation statistics.
RESULTS
A significantly higher proportion of participants treated with OA and in the combined RT/Co condition than those in the ST group, reported a frequency level of TMD pain less than once week at post-treatment and the long-term follow-up. Adolescents treated with OA showed significantly lower TMD pain intensity levels post-treatment than those in the other two treatment conditions. While no difference between the OA and the RT/Co conditions was found in the long-term follow-up, participants in these two conditions were significantly more improved than those in the ST group.
CONCLUSION
Adolescents treated with an OA clearly showed better outcome with regard to intensity and frequency in a long-term follow-up of TMD pain than those treated with RT and ST for nonresponders. These latter individuals need special clinical attention and more effective supplementary treatment methods to be developed.",2020,Adolescents treated with OA showed significantly lower TMD pain intensity levels post-treatment than those in the other two treatment conditions.,"['64 subjects, nonresponders to OA or RT', 'subjects (n = 122', 'temporomandibular disorders (TMDs) 15\u2009years (range 5-21\u2009years) after having received TMD treatment as adolescents due to frequent (at least once a week) TMD pain in two controlled trials', 'All study participants having completed the trials (n = 167']","['control condition (Co), or information and an occlusal appliance (OA) versus relaxation therapy (RT', 'OA']","['pain intensity and frequency of adolescents treated because of temporomandibular disorders', 'frequency level of TMD pain', 'OA and the RT/Co conditions', 'TMD pain intensity levels']","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4517595', 'cui_str': '167'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",167.0,0.031744,Adolescents treated with OA showed significantly lower TMD pain intensity levels post-treatment than those in the other two treatment conditions.,"[{'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Wahlund', 'Affiliation': 'Department of Stomatognathic Physiology, Kalmar County Hospital, Kalmar, Sweden.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Larsson', 'Affiliation': 'Regional Center for Child and Youth Mental Health and Child Welfare - Central Norway, Norwegian University of Science and Technology, Trondheim, Norway.'}]",Clinical and experimental dental research,['10.1002/cre2.289']
168,31876967,The impact of a brief RNR-based training on Turkish juvenile probation officers' punitive and rehabilitative attitudes and recidivism risk perceptions.,"The present quasi-experimental study examined the impact of a brief training program based on the risk-need-responsivity (RNR) model on Turkish juvenile probation officers' (JPOs) punitive and rehabilitative attitudes toward justice-involved youth and recidivism risk perceptions. Fifty-nine JPOs were recruited through three probation offices in Istanbul, Turkey. Thirty-six JPOs, who received a 1-day training in the RNR model of offending behavior, were compared to JPOs in a wait-list control condition (n = 23). Participants in both conditions completed surveys at baseline and 1-week posttraining. Mixed-factorial analysis of variances revealed a significantly higher decrease in JPOs' punitive attitudes from pre- to posttest, in the training condition compared to the control group, with a medium effect size. Rehabilitative attitudes decreased in both conditions, while recidivism risk perceptions did not change from pre- to posttest in either condition. Future research could expand on these promising results using a more intensive training program and a randomized-controlled design in a larger sample of JPOs.",2020,"Rehabilitative attitudes decreased in both conditions, while recidivism risk perceptions did not change from pre- to posttest in either condition.","['Fifty-nine JPOs were recruited through three probation offices in Istanbul, Turkey', ""Turkish juvenile probation officers' (JPOs) punitive and rehabilitative attitudes toward justice-involved youth and recidivism risk perceptions""]","['1-day training', 'RNR-based training']","[""JPOs' punitive attitudes"", 'Rehabilitative attitudes', 'recidivism risk perceptions']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0554967', 'cui_str': 'Turkish (NMO) (ethnic group)'}, {'cui': 'C3146221', 'cui_str': 'Juvenile (finding)'}, {'cui': 'C0401946', 'cui_str': 'Probation officer (occupation)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0162168,"Rehabilitative attitudes decreased in both conditions, while recidivism risk perceptions did not change from pre- to posttest in either condition.","[{'ForeName': 'Ayşe E', 'Initials': 'AE', 'LastName': 'Tuncer', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Erdem', 'Affiliation': 'Koç University, Istanbul, Turkey.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'de Ruiter', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, The Netherlands.'}]",Journal of community psychology,['10.1002/jcop.22310']
169,31163232,The use of 3-dimensionally printed models to optimize patient education and alleviate perioperative anxiety in Mohs micrographic surgery: A randomized controlled trial.,"BACKGROUND
Perioperative patient anxiety in Mohs micrographic surgery (MMS) is associated with increased postoperative pain and decreased satisfaction.
OBJECTIVE
To determine whether a 3-dimensionally printed MMS model with standardized education (SE) improves perioperative patient understanding and anxiety.
METHODS
An unblinded, randomized controlled trial was conducted, with patients randomly assigned to receive the MMS model plus SE or SE alone. Baseline and poststage understanding and anxiety were evaluated with the Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI). Additionally, patients completed a 6-item knowledge assessment.
RESULTS
Eighty-two patients were enrolled, 42 in the MMS model and 40 in the SE group, with similar group mean age (67.8 years), sex (59.8% male), and previous MMS experience (47.6%). Both groups experienced significant reductions in VAS anxiety and State-Trait Anxiety Inventory scores and significant increases in VAS understanding. Compared with SE alone, the MMS model group had larger VAS anxiety reduction (change, -1.31; approaching significance) than the SE group (change, -0.52; P = .052) and 5.59 (93.25%) correct responses versus 5.15 (85.83%) correct responses in the SE group (P < .028).
LIMITATIONS
Overestimations of baseline patient anxiety in our population and 91.1% recruitment of the intended study population limited study power.
CONCLUSION
A 3-dimensionally printed MMS model with SE may improve patient understanding of MMS and decrease perioperative anxiety.",2019,"Compared to SE alone, the MMS model group had larger VAS anxiety reduction approaching significance, Δ = -1.31, than SE group, Δ = -.52","['Eighty-two patients were enrolled, 42 MMS model and 40 SE group, with similar group mean age, (67.8 years), gender (59.8% male), and previous MMS experience (47.6', 'Mohs Micrographic Surgery']","['3D-printed (3DP) MMS model with standardized education (SE', 'micrographic surgery (MMS', 'MMS model plus SE or SE']","['perioperative anxiety', 'VAS anxiety and STAI scores', 'Visual Analog Scale (VAS) and State-Trait Anxiety Inventory (STAI', 'VAS understanding', '6-item knowledge assessment', 'VAS anxiety reduction']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}]",82.0,0.0507265,"Compared to SE alone, the MMS model group had larger VAS anxiety reduction approaching significance, Δ = -1.31, than SE group, Δ = -.52","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Biro', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio. Electronic address: mxb638@case.edu.'}, {'ForeName': 'InYoung', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio; Department of Dermatology, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Huynh', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Pingfu', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Mann', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio; Department of Dermatology, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Popkin', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio; Department of Dermatology, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.05.085']
170,32187462,Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol.,"BACKGROUND
Inclisiran inhibits hepatic synthesis of proprotein convertase subtilisin-kexin type 9. Previous studies suggest that inclisiran might provide sustained reductions in low-density lipoprotein (LDL) cholesterol levels with infrequent dosing.
METHODS
We enrolled patients with atherosclerotic cardiovascular disease (ORION-10 trial) and patients with atherosclerotic cardiovascular disease or an atherosclerotic cardiovascular disease risk equivalent (ORION-11 trial) who had elevated LDL cholesterol levels despite receiving statin therapy at the maximum tolerated dose. Patients were randomly assigned in a 1:1 ratio to receive either inclisiran (284 mg) or placebo, administered by subcutaneous injection on day 1, day 90, and every 6 months thereafter over a period of 540 days. The coprimary end points in each trial were the placebo-corrected percentage change in LDL cholesterol level from baseline to day 510 and the time-adjusted percentage change in LDL cholesterol level from baseline after day 90 and up to day 540.
RESULTS
A total of 1561 and 1617 patients underwent randomization in the ORION-10 and ORION-11 trials, respectively. Mean (±SD) LDL cholesterol levels at baseline were 104.7±38.3 mg per deciliter (2.71±0.99 mmol per liter) and 105.5±39.1 mg per deciliter (2.73±1.01 mmol per liter), respectively. At day 510, inclisiran reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and 49.2% (95% CI, 46.8 to 51.6) (P<0.001 for all comparisons vs. placebo). Adverse events were generally similar in the inclisiran and placebo groups in each trial, although injection-site adverse events were more frequent with inclisiran than with placebo (2.6% vs. 0.9% in the ORION-10 trial and 4.7% vs. 0.5% in the ORION-11 trial); such reactions were generally mild, and none were severe or persistent.
CONCLUSIONS
Reductions in LDL cholesterol levels of approximately 50% were obtained with inclisiran, administered subcutaneously every 6 months. More injection-site adverse events occurred with inclisiran than with placebo. (Funded by the Medicines Company; ORION-10 and ORION-11 ClinicalTrials.gov numbers, NCT03399370 and NCT03400800.).",2020,"At day 510, inclisiran reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and 49.2% (95% CI, 46.8 to 51.6) (P<0.001 for all comparisons vs. placebo).","['Patients with Elevated LDL Cholesterol', 'enrolled patients with atherosclerotic cardiovascular disease (ORION-10 trial) and patients with atherosclerotic cardiovascular disease or an atherosclerotic cardiovascular disease risk equivalent (ORION-11 trial) who had elevated LDL cholesterol levels despite receiving statin therapy at the maximum tolerated dose', 'A total of 1561 and 1617 patients underwent randomization in the ORION-10 and ORION-11 trials, respectively']","['inclisiran', 'placebo']","['low-density lipoprotein (LDL) cholesterol levels', 'Adverse events', 'injection-site adverse events', 'LDL cholesterol levels', 'LDL cholesterol level', 'Mean (±SD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C4307388', 'cui_str': 'inclisiran'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.622195,"At day 510, inclisiran reduced LDL cholesterol levels by 52.3% (95% confidence interval [CI], 48.8 to 55.7) in the ORION-10 trial and by 49.9% (95% CI, 46.6 to 53.1) in the ORION-11 trial, with corresponding time-adjusted reductions of 53.8% (95% CI, 51.3 to 56.2) and 49.2% (95% CI, 46.8 to 51.6) (P<0.001 for all comparisons vs. placebo).","[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Wright', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kallend', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Jenna A', 'Initials': 'JA', 'LastName': 'Bisch', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Richardson', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jaros', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'Peter L J', 'Initials': 'PLJ', 'LastName': 'Wijngaard', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': ""From the Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, London (K.K.R.); the Department of Cardiology, Mayo Clinic, Rochester, MN (R.S.W.); the Medicines Company, Zurich, Switzerland (D.K.); Deutsches Herzzentrum München, Technische Universität München, and Deutsches Zentrum für Herz-Kreislauf-Forschung (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and the Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm - all in Germany (W.K.); Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.); the Department of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Medicines Company, Parsippany, NJ (J.A.B., T.R., P.L.J.W.); Summit Analytical, Denver (M.J.), and the Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam (J.J.P.K.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1912387']
171,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN
Parallel-group, quasi-experimental study.
OBJECTIVES
To evaluate the effectiveness of a coping-oriented supportive programme (COSP) for people with spinal cord injury (SCI) over a 12-week follow-up.
SETTING
SCI wards in two rehabilitation hospitals of Shaanxi, China.
METHODS
Ninety-nine participants (mean age = 41, 88% males and 74% paraplegia) joined the COSP intervention (n = 50) or attention control (n = 49) group. The COSP intervention was focussed on the facilitation of coping skills and consisted of 8 weekly sessions, whereas the attentional control group was provided with 8 weekly didactic education sessions. Effects of the COSP intervention were determined by primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain). Data were collected at pre- and post-intervention, as well as 4- and 12-week follow-up.
RESULTS
Intention to treat analysis indicated statistically significant effects (with moderate to large effect sizes, all P-values < 0.01) on participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction immediately post-COSP. Statistically significant effects were found for maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction at 4-week follow-up. Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
CONCLUSION
The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2']
172,32297539,Bayesian methods for pilot studies.,"BACKGROUND/AIMS
The use of pilot studies to help inform the design of randomized controlled trials has increased significantly over the last couple of decades. A pilot study can provide estimates of feasibility parameters, such as the recruitment, compliance and follow-up probabilities. The use of frequentist confidence intervals of these estimates fails to provide a meaningful measure of the uncertainty as it pertains to the design of the associated randomized controlled trial. The objective of this article is to introduce Bayesian methods for the analysis of pilot studies for determining the feasibility of an associated randomized controlled trial.
METHODS
An example from the literature is used to illustrate the advantages of a Bayesian approach for accounting for the uncertainty in pilot study results when assessing the feasibility of an associated randomized controlled trial. Vague beta distribution priors for the feasibility parameters are used. Based on the results from a feasibility study, simulation methods are used to determine the expected power of specified recruitment strategies for an associated randomized controlled trial.
RESULTS
The vague priors used for the feasibility parameters are demonstrated to be considerably robust. Beta distribution posteriors for the feasibility parameters lead to beta-binomial predictive distributions for an associated randomized controlled trial regarding the number of patients randomized, the number of patients who are compliant and the number of patients who complete follow-up. Ignoring the uncertainty in pilot study results can lead to inadequate power for an associated randomized controlled trial.
CONCLUSION
Applying Bayesian methods to pilot studies' results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way. Furthermore, Bayesian methods can identify recruitment strategies that yield the desired power for an associated randomized controlled trial.",2020,Applying Bayesian methods to pilot studies' results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way.,[],[],[],[],[],[],,0.158836,Applying Bayesian methods to pilot studies' results provides direct inference about the feasibility parameters and quantifies the uncertainty regarding the feasibility of an associated randomized controlled trial in an intuitive and meaningful way.,"[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'Ontario Child Health Support Unit, SickKids Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}]","Clinical trials (London, England)",['10.1177/1740774520914306']
173,31462757,Sprint interval training versus moderate-intensity continuous training during inpatient rehabilitation after spinal cord injury: a randomized trial.,"STUDY DESIGN
Randomized trial.
OBJECTIVES
To evaluate the effectiveness of a 5-week sprint interval training (SIT) protocol on an arm-crank ergometer in individuals with sub-acute spinal cord injury (SCI).
SETTING
Inpatient rehabilitation.
METHODS
Individuals with SCI (N = 20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46 ± 16 years; 15 M/5 F) were randomized to SIT or moderate-intensity continuous training (MICT). SIT consisted of 3 × 20 s. 'all-out' cycle sprints (≥100% peak power output) interspersed with 2 min of active recovery (10% peak power output; total time commitment, 10 mins). MICT involved 20 min of cycling (45% peak power output; total time commitment, 25 mins). Both training interventions were delivered 3 times/week for 5 weeks. Heart rate and Borg's Rating of Perceived Exertion (RPE; 6-20) were monitored throughout training sessions. Maximal and sub-maximal power outputs were assessed on an arm-crank ergometer. Exercise enjoyment, exercise self-efficacy, and pain were assessed at the end of the intervention.
RESULTS
During training sessions, heart rate (135 bpm vs. 119 bpm; p = 0.05), peripheral RPE (16 vs. 12; p = 0.000), and central RPE (15 vs. 11; p = 0.004) responses were higher in the SIT group, yet total work performed was greater in MICT. Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524). Similarly, improvements in sub-maximal power output were not different across groups. There were no between-group differences in exercise enjoyment (p = 0.385), exercise self-efficacy (p = 0.930), or pain (p = 0780).
CONCLUSIONS
Five weeks of SIT improved physical capacity to the same extent as MICT in individuals with sub-acute SCI, despite a significantly lower time commitment with SIT.",2020,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","['inpatient rehabilitation after spinal cord injury', 'Individuals with SCI (N\u2009', 'Inpatient rehabilitation', '20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46\u2009±\u200916 years; 15\u2009M/5\u2009F', 'individuals with sub-acute spinal cord injury (SCI']","['MICT', 'SIT or moderate-intensity continuous training (MICT', 'Sprint interval training versus moderate-intensity continuous training', '5-week sprint interval training (SIT) protocol']","['sub-maximal power output', 'Exercise enjoyment, exercise self-efficacy, and pain', ""Heart rate and Borg's Rating of Perceived Exertion"", 'Peak power output', 'heart rate', 'physical capacity', 'exercise enjoyment', 'peripheral RPE', 'exercise self-efficacy', 'central RPE']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0449246', 'cui_str': 'Time since injury (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",780.0,0.0764155,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Mcleod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Herrington', 'Initials': 'H', 'LastName': 'Diana', 'Affiliation': 'Regional Rehabilitation Centre, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada. hicksal@mcmaster.ca.'}]",Spinal cord,['10.1038/s41393-019-0345-6']
174,31312016,Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial.,"STUDY DESIGN
Randomized controlled trial.
OBJECTIVE
To determine the effects of advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES) of the quadriceps and gastrocnemius muscles on the ability of wheelchair-dependent people with spinal cord injury (SCI) to transfer and attain independence in activities of daily living (ADLs).
SETTING
An outpatient clinic, Iran.
METHODS
People with traumatic chronic paraplegia (N = 16) were randomly allocated to three groups. The exercise group (EX; N = 5) performed AWMEs of quadruped unilateral reaching and tall-kneeling for 24 weeks (3 days/week). Sessions were increased from 10 min to 54 min over the 24-week period. The exercise-FES group (EX + FES; N = 5) performed AWMEs simultaneously with FES of the quadriceps and gastrocnemius muscles. The control group performed no exercise and no FES (N = 6). The primary outcomes were the total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer. There were six other outcomes.
RESULTS
The mean (95% CI) between-group differences of the four transfer items of the SCIM-III for the EX vs. control group was 1.8 points (0.2-3.4), and for the EX + FES vs. control group was 2 points (0.4-3.6). The equivalent differences for the total SCIM-III scores were 2.7 points (-0.6-6.0) and 4.1 points (0.8-7.4), respectively. There were no significant between-group differences for any other outcomes.
CONCLUSIONS
Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.",2020,"CONCLUSIONS
Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","['People with traumatic chronic paraplegia (N\u2009=\u200916', 'wheelchair-dependent people with spinal cord injury (SCI', 'An outpatient clinic, Iran']","['no exercise and no FES', 'advanced weight-bearing mat exercises (AWMEs) with/without functional electrical stimulation (FES', 'Advanced weight-bearing mat exercises combined with functional electrical stimulation', 'exercise group (EX; N\u2009=\u20095) performed AWMEs of quadruped unilateral reaching and tall-kneeling']","['total SCIM-III scores', 'total Spinal Cord Independence Measure-III (SCIM-III) to reflect independence with ADL, and the sum of the four SCIM-III transfer items to reflect ability to transfer']","[{'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C3698571', 'cui_str': 'Chronic paraplegia'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456677', 'cui_str': 'Total spinal blockade (finding)'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0665244,"CONCLUSIONS
Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Torkaman', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. torkamg@modares.ac.ir.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Ghabaee', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Departments of Medicine and Endocrinology, Austin Health, The University of Melbourne, Melbourne, VIC, Australia.'}]",Spinal cord,['10.1038/s41393-019-0328-7']
175,31754048,Preoperative β-Blockade with Propranolol Reduces Biomarkers of Metastasis in Breast Cancer: A Phase II Randomized Trial.,"PURPOSE
The majority of deaths from breast cancer occur following the development of metastatic disease, a process inhibited by β-blockers in preclinical studies. This phase II randomized controlled trial evaluated the effect of preoperative β-blockade with propranolol on biomarkers of metastatic potential and the immune cell profile within the primary tumor of patients with breast cancer.
PATIENTS AND METHODS
In this triple-blind placebo-controlled clinical trial, 60 patients were randomly assigned to receive an escalating dose of oral propranolol ( n = 30; 80-160 mg daily) or placebo ( n = 30) for 7 days prior to surgery. The primary endpoint investigated the effect of propranolol on prometastatic and proinflammatory gene expression within the primary tumor.
RESULTS
Propranolol downregulated primary tumor expression of mesenchymal genes ( P = 0.002) without affecting epithelial gene expression ( P = 0.21). Bioinformatic analyses implicated downregulation of Snail/Slug ( P = 0.03), NF-κB/Rel ( P < 0.01), and AP-1 ( P < 0.01) transcription factors in structuring the observed transcriptome alterations, and identified changes in intratumoral neutrophil, natural killer cell, and dendritic cell recruitment (all P < 0.01). Patients with clinical evidence of drug response (lowered heart rate and blood pressure) demonstrated elevated tumor infiltration of CD68 + macrophages and CD8 + T cells.
CONCLUSIONS
One week of β-blockade with propranolol reduced intratumoral mesenchymal polarization and promoted immune cell infiltration in early-stage surgically-resectable breast cancer. These results show that β-blockade reduces biomarkers associated with metastatic potential, and support the need for larger phase III clinical trials powered to detect the impact of β-blockade on cancer recurrence and survival. See related commentary by Blaes et al., p. 1781 .",2020,"Bioinformatic analyses implicated down-regulation of Snail/Slug (P = 0.03), NF-κB/Rel (P < 0.01), and AP-1 (P < 0.01) transcription factors in structuring the observed transcriptome alterations, and identified changes in intra-tumoral neutrophil, NK cell, and dendritic cell recruitment (all P < 0.01).","['breast cancer', 'early stage surgically-resectable breast cancer', 'patients with breast cancer', '60 patients']","['β-blockade', 'Propranolol', 'pre-operative β-blockade with propranolol', 'oral propranolol', 'propranolol', 'placebo']","['intra-tumoral neutrophil, NK cell, and dendritic cell recruitment', 'heart rate and blood pressure) demonstrated elevated tumor infiltration of CD68+ macrophages and CD8+ T cells', 'pro-metastatic and pro-inflammatory gene expression within the primary tumor', 'cancer recurrence and survival', 'AP-1', 'NF-κB/Rel']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0085828', 'cui_str': 'AP-1'}]",60.0,0.115135,"Bioinformatic analyses implicated down-regulation of Snail/Slug (P = 0.03), NF-κB/Rel (P < 0.01), and AP-1 (P < 0.01) transcription factors in structuring the observed transcriptome alterations, and identified changes in intra-tumoral neutrophil, NK cell, and dendritic cell recruitment (all P < 0.01).","[{'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Hiller', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia. jonathan.hiller@petermac.org erica.sloan@monash.edu.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, UCLA Molecular Biology Institute, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Crone', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Byrne', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shackleford', 'Affiliation': 'Centre for Drug Candidate Optimisation, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Melbourne, Australia.'}, {'ForeName': 'Jia-Min B', 'Initials': 'JB', 'LastName': 'Pang', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Henderson', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia.'}, {'ForeName': 'Sophie S', 'Initials': 'SS', 'LastName': 'Nightingale', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia.'}, {'ForeName': 'Kwok M', 'Initials': 'KM', 'LastName': 'Ho', 'Affiliation': 'Department of Intensive Care Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Myles', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Fox', 'Affiliation': 'Department of Pathology, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Riedel', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia.'}, {'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Sloan', 'Affiliation': 'Division of Cancer Surgery, Peter MacCallum Cancer Centre, Victorian Comprehensive Cancer Centre, Parkville, Melbourne, Australia. jonathan.hiller@petermac.org erica.sloan@monash.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-2641']
176,31320177,The association of serum interleukin-6 levels with clinical outcomes in antineutrophil cytoplasmic antibody-associated vasculitis.,"OBJECTIVE
To investigate serum IL-6 (sIL-6) levels during active disease, complete remission (CR), and relapse in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), and to explore the association of changes in sIL-6 with clinical outcomes.
METHODS
sIL-6 levels were measured at baseline and longitudinally over 18 months, in 78 patients with AAV enrolled in a randomized controlled trial comparing treatment with either rituximab (RTX) or cyclophosphamide (CYC)/azathioprine (AZA). Outcome variables included baseline clinical features, ANCA specificity, disease activity (active disease versus CR), time to relapse events, B cell repopulation, and ANCA titer increases.
RESULTS
At baseline, sIL6 levels were detectable in 81% of patients; 73% (n = 57) of subjects were proteinase 3 (PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s = -0.17,p = 0.47). Higher baseline sIL-6 levels were associated with PR3-ANCA positivity, fever, pulmonary nodules/cavities, conductive deafness, and absence of urinary red blood cell casts (p < 0.05). Baseline sIL6 levels did not predict CR at month 6 (p = 0.71), and the median sIL-6 level declined from baseline with induction therapy, regardless of CR achievement. An increase in sIL-6 during CR was a predictor for subsequent severe relapse in RTX-treated patients (hazard ratio (HR):7.24,p = 0.01), but not in CYC/AZA-treated patients (HR:0.62,p = 0.50). In contrast, a sIL-6 increase did not predict B cell repopulation or ANCA titer increase in either treatment arm (p > 0.05).
CONCLUSION
At baseline, sIL-6 concentrations correlate with PR3-ANCA titers and are associated with specific clinical manifestations of AAV. Baseline sIL6 concentrations do not predict CR at 6 months, but the increase in sIL-6 concentrations during CR is associated with subsequent severe relapse among RTX-treated patients. Further investigation into the mechanistic role of IL6 in AAV might lead to identifying this pathway as a potential therapeutic target in this disease.",2019,"(PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s = -0.17,p = 0.47).",['78 patients with AAV enrolled'],['rituximab (RTX) or cyclophosphamide (CYC)/azathioprine (AZA'],"['PR3-ANCA positivity, fever, pulmonary nodules/cavities, conductive deafness, and absence of urinary red blood cell casts', 'baseline clinical features, ANCA specificity, disease activity (active disease versus CR), time to relapse events, B cell repopulation, and ANCA titer increases', 'sIL-6 increase did not predict B cell repopulation or ANCA titer increase', 'sIL6 levels', 'Baseline sIL6 concentrations', 'sIL-6', 'serum IL-6', 'Higher baseline sIL-6 levels', 'sIL-6 concentrations', 'Baseline sIL6 levels', 'sIL-6) levels during active disease, complete remission (CR), and relapse in antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV', 'median sIL-6 level', 'PR3)-ANCA positive, sIL-6 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0201530', 'cui_str': 'Antineutrophil cytoplasmic antibody measurement (procedure)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C1510420', 'cui_str': 'Cavity (morphologic abnormality)'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss (disorder)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2609436', 'cui_str': 'Vasculitis (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0238874', 'cui_str': 'Antineutrophil cytoplasmic antibody positive (finding)'}]",78.0,0.149311,"(PR3)-ANCA positive, sIL-6 levels were higher in subjects with PR3-ANCAs and positively correlated with their levels (r s = 0.36,p < 0.01), but not with levels of myeloperoxidase (MPO)-ANCA (r s = -0.17,p = 0.47).","[{'ForeName': 'Alvise', 'Initials': 'A', 'LastName': 'Berti', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Roscoe', 'Initials': 'R', 'LastName': 'Warner', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Johnson', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Divi', 'Initials': 'D', 'LastName': 'Cornec', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Darrell R', 'Initials': 'DR', 'LastName': 'Schroeder', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Brian F', 'Initials': 'BF', 'LastName': 'Kabat', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Cees G M', 'Initials': 'CGM', 'LastName': 'Kallenberg', 'Affiliation': 'University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Seo', 'Affiliation': 'Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Spiera', 'Affiliation': 'Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Fervenza', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stone', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Monach', 'Affiliation': 'Boston University and VA Boston Healthcare System, Boston, MA, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: specks.ulrich@mayo.edu.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of autoimmunity,['10.1016/j.jaut.2019.07.001']
177,32294534,Reducing Missed Opportunities for Human Papillomavirus Vaccination in School-Based Health Centers: Impact of an Intervention.,"OBJECTIVE
Human papillomavirus (HPV) immunization rates among US adolescents are low. Missed opportunities (MOs) for HPV vaccination are common. School-based health centers (SBHCs) have potential to boost HPV vaccination, but their role in addressing MOs has not been examined.
METHODS
We implemented a multicomponent intervention, consisting of 3 immunization process workflow modifications combined with provider performance feedback, in 2 Los Angeles area SBHCs and conducted a pre/post evaluation of MOs. Our primary outcome was SBHC-based MOs for HPV vaccination during all visits, including visits for confidential reproductive health care (ie, confidential visits). Secondary outcomes were MOs for meningococcal (MenACWY) and influenza vaccination during visits for nonconfidential care.
RESULTS
MOs for HPV vaccination decreased during all visit types from the baseline to the intervention period (82.3% to 46.1%; adjusted risk ratio [RR] = 0.558, P < .0001). The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs 98.7% to 70.4%, respectively). MOs for MenACWY (74.5% to 35.0%; adjusted RR = 0.47, P < .0001) and influenza (86.7% to 69.3%; adjusted RR = 0.792, P < .0001) vaccination also decreased during nonconfidential visits. Vaccine refusal was the most frequently documented reason for HPV vaccine MOs during both physical examination and confidential visits.
CONCLUSIONS
A pragmatic, multicomponent SBHC intervention reduced MOs for HPV vaccination during all visit types. MOs for MenACWY and influenza vaccination also decreased during nonconfidential visits. Findings suggest that practice-level improvements in SBHCs can improve delivery of HPV and other adolescent vaccines.",2020,"The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs. 98.7% to 70.4%, respectively).",['Human Papillomavirus Vaccination in School-Based Health Centers'],[],"['MOs for MenACWY and influenza vaccination', 'MOs for HPV vaccination', 'MOs for meningococcal (MenACWY) and influenza vaccination during visits for non-confidential care', 'HPV vaccination', 'SBHC-based MOs for HPV vaccination during all visits, including visits for confidential reproductive health care (i.e., confidential visits']","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]",[],"[{'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}]",,0.0638702,"The rate decrease appeared to be greater during physical examination visits than confidential visits (83.4% to 31.6% vs. 98.7% to 70.4%, respectively).","[{'ForeName': 'Megha D', 'Initials': 'MD', 'LastName': 'Shah', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif. Electronic address: mshah@ph.lacounty.gov.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Glenn', 'Affiliation': 'UCLA Kaiser Permanente Center for Health Equity (BA Glenn and LC Chang), Los Angeles, Calif; Jonsson Comprehensive Cancer Center at UCLA (BA Glenn and LC Chang), Los Angeles, Calif; Department of Health Policy and Management, UCLA Fielding School of Public Health (BA Glenn), Los Angeles, Calif.'}, {'ForeName': 'L Cindy', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'UCLA Kaiser Permanente Center for Health Equity (BA Glenn and LC Chang), Los Angeles, Calif; Jonsson Comprehensive Cancer Center at UCLA (BA Glenn and LC Chang), Los Angeles, Calif.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Chung', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Uyeda', 'Affiliation': 'Los Angeles Unified School District (K Uyeda), Los Angeles, Calif. Dr Shah is now with the Los Angeles County Department of Public Health, Office of Health Assessment and Epidemiology, Los Angeles, Calif. Dr Chung is now with the Department of Health Systems Science, Kaiser Permanente School of Medicine, Pasadena, Calif. Dr Uyeda is now with the California School-Based Health Alliance, Oakland, Calif.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Division of General Pediatrics, Department of Pediatrics, David Geffen School of Medicine and UCLA Mattel Children's Hospital (University of California, Los Angeles) (MD Shah, PJ Chung, R Valderrama, and PG Szilagyi), Los Angeles, Calif.""}]",Academic pediatrics,['10.1016/j.acap.2020.04.002']
178,31606589,Effect of lofexidine on cardiac repolarization during treatment of opioid withdrawal.,"BACKGROUND
Lofexidine is a non-opioid treatment for opioid withdrawal syndrome. Its sympatholytic actions counteract the nor-adrenergic hyperactivity that occurs during abrupt opioid withdrawal.
METHODS
The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186). ECGs were time-matched to blood sampling for lofexidine concentration and were collected at prespecified timepoints over a 7-day inpatient period. Analyses included mean change-from-baseline QTcF and exposure-response modeling to predict QTcF at relevant lofexidine concentrations.
RESULTS
A total of 681 adult men and women received at least 1 dose of study drug; 566 qualified for inclusion in the concentration-QTcF analysis. Most subjects were withdrawing from heroin. During the first 24 h (Days 1-2) post-baseline, small increases in QTcF were observed in all groups: 4.7 ms for lofexidine 2.16 mg, 7.4 ms for lofexidine 2.88 mg and 1.4 ms for placebo. These increases were transient; by Day 4, when lofexidine levels had reached steady-state, QTcF increases were not present. By Day 7, QTcF was decreased from baseline in all groups. Exposure-response modeling predicted <10 ms increases in QTcF at lofexidine concentrations 3 times those obtained at maximal recommended dose.
CONCLUSIONS
Lofexidine was associated with small, transient QTcF increases. Decreases in QTcF that occurred with higher lofexidine concentrations argue for an indirect QTcF effect, potentially from changes in autonomic tone. Both opioid withdrawal and lofexidine's sympatholytic actions would be expected to alter sympathetic outflow over the 7-day withdrawal.",2019,"The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186).",['681 adult men and women received at least 1 dose of study drug; 566 qualified for inclusion in the concentration-QTcF analysis'],"['Lofexidine', 'placebo', ""lofexidine's sympatholytic actions"", 'lofexidine']","['cardiac repolarization', 'autonomic tone', 'QTcF', 'QTcF (QT interval, heart-rate corrected, Fridericia formula', 'sympathetic outflow']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0065152', 'cui_str': 'lofexidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039051', 'cui_str': 'Sympatholytic Agents'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",681.0,0.161758,"The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186).","[{'ForeName': 'Börje', 'Initials': 'B', 'LastName': 'Darpö', 'Affiliation': ""Department of Clinical Sciences, Karolinska Institute, Danderyd's Hospital, 182 88 Stockholm, Sweden. Electronic address: borje.darpo@telia.com.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pirner', 'Affiliation': 'Department of Clinical Research and Medical Affairs, US WorldMeds, LLC, 4441 Springdale Rd, Louisville, KY 40241, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Longstreth', 'Affiliation': 'Longstreth and Associates, Inc., 450 N Lakeshore Dr, Mundelein, IL 60060, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ferber', 'Affiliation': 'Statistik Georg Ferber GmbH, Cagliostrostrasse 14, 4125 Riehen, Switzerland.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107596']
179,32294620,Hydration Does Not Change Postexercise Hypotension and Its Mechanisms.,"BACKGROUND
Drinking water is recommended before and after exercise to avoid dehydration. However, water ingestion may mitigate or prevent postexercise hypotension. This study investigated the effects of intentional hydration on postaerobic exercise hemodynamics and autonomic modulation.
METHODS
A total of 18 young men randomly underwent 4 experimental sessions as follows: (1) control with intentional hydration (1 L of water in the previous night, 500 mL 60 min before the intervention, and 1 mL for each 1 g of body mass lost immediately after the intervention); (2) control without intentional hydration (ad libitum water ingestion before the intervention); (3) exercise (cycle ergometer, 45 min, 50% of VO2peak) with intentional hydration; and (4) exercise without intentional hydration. Hemodynamic and autonomic parameters were measured before and after the interventions and were compared by 3-way analysis of variance.
RESULTS
Intentional hydration did not change any postexercise hemodynamic nor autonomic response. Exercise decreased systolic blood pressure and stroke volume (-4.1 [0.8] mm Hg and -4.9 [1.5] mL, P < .05), while increased cardiac sympathovagal balance (0.3 [0.3], P < .05) during the recovery. In addition, it abolished the increase in diastolic blood pressure and the decrease in heart rate observed in the control sessions.
CONCLUSION
Intentional hydration does not modify the hypotensive effect promoted by previous aerobic exercise and did not alter its hemodynamic and autonomic mechanisms.",2020,Intentional hydration does not modify the hypotensive effect promoted by previous aerobic exercise and did not alter its hemodynamic and autonomic mechanisms.,['18 young men randomly underwent 4 experimental sessions as follows: '],"['intentional hydration (1\xa0L of water in the previous night, 500\xa0mL 60\xa0min before the intervention, and 1\xa0mL for each 1\xa0g of body mass lost immediately after the intervention); (2)\xa0control without intentional hydration (ad libitum water ingestion before the intervention); (3)\xa0exercise (cycle ergometer, 45\xa0min, 50% of VO2peak) with intentional hydration; and (4)\xa0exercise without intentional hydration', 'intentional hydration']","['postexercise hypotension', 'postexercise hemodynamic nor autonomic response', 'diastolic blood pressure', 'systolic blood pressure and stroke volume', 'hypotensive effect', 'heart rate', 'Hemodynamic and autonomic parameters', 'cardiac sympathovagal balance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",18.0,0.023411,Intentional hydration does not modify the hypotensive effect promoted by previous aerobic exercise and did not alter its hemodynamic and autonomic mechanisms.,"[{'ForeName': 'Fernando S', 'Initials': 'FS', 'LastName': 'Lobo', 'Affiliation': ''}, {'ForeName': 'Andreia C C', 'Initials': 'ACC', 'LastName': 'Queiroz', 'Affiliation': ''}, {'ForeName': 'Natan D', 'Initials': 'ND', 'LastName': 'Silva Junior', 'Affiliation': ''}, {'ForeName': 'Fabio L', 'Initials': 'FL', 'LastName': 'Medina', 'Affiliation': ''}, {'ForeName': 'Luiz A R', 'Initials': 'LAR', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Tinucci', 'Affiliation': ''}, {'ForeName': 'Claudia L M', 'Initials': 'CLM', 'LastName': 'Forjaz', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0476']
180,31710994,Individual differences in human opioid abuse potential as observed in a human laboratory study.,"BACKGROUND
Opioids have high abuse potential and pose a major public health concern. Yet, a large percentage of individuals exposed to opioids do not develop problematic use. Individual differences in opioid abuse potential are not well understood.
METHODS
This within-subject (N = 16), double-blind, double-dummy, human laboratory study evaluated individual differences in response to dose (placebo, low, medium, high) following administration of heroin and hydromorphone through intravenous and subcutaneous routes, in opioid-experienced but non physically-dependent participants. Outcomes were self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire. The degree to which results were consistent across measures within an individual was assessed using a mixed-effects model from which an intraclass correlation coefficient measure of between and within-subject variance was derived.
RESULTS
The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent. Visual inspection reveals a myriad response pattern across participants, with some demonstrating classic dose-effect responses and others not differentiating any active doses from placebo.
CONCLUSIONS
Data suggest the abuse potential of opioids is significantly different between individuals but that the experience within an individual is highly consistent. Research to prospectively characterize and evaluate mechanisms underlying these differences is warranted and may provide a foundation to help identify persons at heightened risk of transitioning from opioid exposure to misuse and/or opioid use disorder.",2019,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.",[],['heroin and hydromorphone'],"['self-reported visual analog scale (VAS) ratings (High, Liking, Drug Effect, Good Effect, Rush), pupil diameter change from baseline, and crossover point on the Drug vs. Money questionnaire']",[],"[{'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443052', 'cui_str': 'Rush (qualifier value)'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.212725,"The mixed effects model fit was significant (p < 0.0001) and revealed that 85.5% of the explainable variance was due to between-subject effects, suggesting the responses within an individual were highly consistent.","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dunn', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States. Electronic address: kdunn9@jhmi.edu.'}, {'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': 'Health Canada, Canada; Centre for Addiction and Mental Health, Canada; University of Toronto, Canada.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Marsh', 'Affiliation': 'Northern Ontario School of Medicine, Canada.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107688']
181,32295808,Efficacy and Safety of 1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide in Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs: The LixiLan JP-O1 Randomized Clinical Trial.,"OBJECTIVE
To assess the efficacy and safety of a 1:1 fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi) in insulin-naive Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).
RESEARCH DESIGN AND METHODS
In this phase 3, open-label, multicenter trial, 321 patients with HbA 1c ≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL) were randomized 1:1 to iGlarLixi or Lixi for 52 weeks. The primary end point was change in HbA 1c at week 26.
RESULTS
Change in HbA 1c from baseline to week 26 was significantly greater with iGlarLixi (-1.58% [-17.3 mmol/mol]) than with Lixi (-0.51% [-5.6 mmol/mol]), confirming the superiority of iGlarLixi (least squares [LS] mean difference -1.07% [-11.7 mmol/mol], P < 0.0001). At week 26, significantly greater proportions of patients treated with iGlarLixi reached HbA 1c <7% (53 mmol/mol) (65.2% vs. 19.4%; P < 0.0001), and FPG reductions were greater with iGlarLixi than Lixi (LS mean difference -2.29 mmol/L [-41.23 mg/dL], P < 0.0001). Incidence of documented symptomatic hypoglycemia (≤3.9 mmol/L [70 mg/dL]) was higher with iGlarLixi (13.0% vs. 2.5%) through week 26, with no severe hypoglycemic events in either group. Incidence of gastrointestinal events through week 52 was lower with iGlarLixi (36.0% vs. 50.0%), and rates of treatment-emergent adverse events were similar.
CONCLUSIONS
This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.",2020,"This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.","['Japanese patients with T2DM', 'insulin-naïve Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs', 'Japanese Patients With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs', '321 patients with HbA 1c ≥7.5 to ≤10.0% (58-86 mmol/mol) and fasting plasma glucose (FPG) ≤13.8 mmol/L (250 mg/dL']","['1:1 Fixed-Ratio Combination of Insulin Glargine and Lixisenatide Versus Lixisenatide', 'iGlarLixi or Lixi', 'insulin glargine and lixisenatide (iGlarLixi) versus lixisenatide (Lixi', 'iGlarLixi']","['Efficacy and Safety', 'FPG reductions', 'change in HbA 1c', 'rates of treatment-emergent adverse events', 'Incidence of documented symptomatic hypoglycemia', 'efficacy and safety', 'severe hypoglycemic events', 'Incidence of gastrointestinal events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4293375', 'cui_str': 'insulin glargine and lixisenatide'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",321.0,0.0516409,"This phase 3 study demonstrated superior glycemic control and fewer gastrointestinal adverse events with iGlarLixi than with Lixi, which may support it as a new treatment option for Japanese patients with T2DM that is inadequately controlled with OADs.","[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan hwatada@juntendo.ac.jp.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Takami', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spranger', 'Affiliation': 'Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Amano', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Hashimoto', 'Affiliation': 'Research & Development, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}]",Diabetes care,['10.2337/dc19-2452']
182,31924736,Radiological Evaluation of Newly Diagnosed Non-Brainstem Pediatric High-Grade Glioma in the HERBY Phase II Trial.,"PURPOSE
The HERBY trial evaluated the benefit of the addition of the antiangiogenic agent Bevacizumab (BEV) to radiotherapy/temozolomide (RT/TMZ) in pediatric patients with newly diagnosed non-brainstem high-grade glioma (HGG). The work presented here aims to correlate imaging characteristics and outcome measures with pathologic and molecular data.
EXPERIMENTAL DESIGN
Radiological, pathologic, and molecular data were correlated with trial clinical information to retrospectively re-evaluate event-free survival (EFS) and overall survival (OS).
RESULTS
One-hundred thirteen patients were randomized to the RT/TMZ arm ( n = 54) or the RT/TMZ+BEV (BEV arm; n = 59). The tumor arose in the cerebral hemispheres in 68 patients (Cerebral group) and a midline location in 45 cases (Midline group). Pathologic diagnosis was available in all cases and molecular data in 86 of 113. H3 K27M histone mutations were present in 23 of 32 Midline cases and H3 G34R/V mutations in 7 of 54 Cerebral cases. Total/near-total resection occurred in 44 of 68 (65%) Cerebral cases but in only 5 of 45 (11%) Midline cases ( P < 0.05). Leptomeningeal metastases (27 cases, 13 with subependymal spread) at relapse were more frequent in Midline (17/45) than in Cerebral tumors (10/68, P < 0.05). Mean OS (14.1 months) and EFS (9.0 months) in Midline tumors were significantly lower than mean OS (20.7 months) and EFS (14.9 months) in Cerebral tumors ( P < 0.05). Pseudoprogression occurred in 8 of 111 (6.2%) cases.
CONCLUSIONS
This study has shown that the poor outcome of midline tumors (compared with cerebral) may be related to (1) lesser surgical resection, (2) H3 K27M histone mutations, and (3) higher leptomeningeal dissemination.",2020,"Leptomeningeal metastases (27 cases, 13 with subependymal spread) at relapse were more frequent in Midline (17/45) than Cerebral tumors (10/68, p <0.05).","['newly diagnosed non-brainstem pediatric high-grade glioma in the HERBY phase II trial', 'pediatric patients with newly diagnosed non-brainstem high-grade glioma (HGG', '68 patients (Cerebral group) and a midline location in 45 cases (Midline group', 'One-hundred thirteen patients']","['RT/TMZ', 'RT/TMZ+BEV', 'antiangiogenic agent Bevacizumab (BEV) to radiotherapy/Temozolomide (RT/TMZ']","['Pathological diagnosis', 'Mean OS', 'Total/near-total resection', 'Pseudoprogression', 'Leptomeningeal metastases']","[{'cui': 'C0006121', 'cui_str': 'Truncus Cerebri'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0017638', 'cui_str': 'Glial Cell Tumors'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0596087', 'cui_str': 'Inhibitors, Angiogenetic'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",113.0,0.03194,"Leptomeningeal metastases (27 cases, 13 with subependymal spread) at relapse were more frequent in Midline (17/45) than Cerebral tumors (10/68, p <0.05).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rodriguez Gutierrez', 'Affiliation': 'Medical Physics and Clinical Engineering, Nottingham University Hospital Trust, Nottingham, United Kingdom. cabovidio@gmail.com.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Divisions of Molecular Pathology and Cancer Therapeutics, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Varlet', 'Affiliation': 'Anatomie et cytologie pathologiques, Centre Hospitalier Sainte Anne, Paris, France.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Mackay', 'Affiliation': 'Divisions of Molecular Pathology and Cancer Therapeutics, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Warren', 'Affiliation': 'Department of Radiology, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Warmuth-Metz', 'Affiliation': 'Institute for Diagnostic and Interventional Neuroradiology, Würzburg University, Würzburg, Germany.'}, {'ForeName': 'Esther Sánchez', 'Initials': 'ES', 'LastName': 'Aliaga', 'Affiliation': 'Department of Radiology and Nuclear Medicine, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Calmon', 'Affiliation': 'Pediatric Radiology, Necker Enfants Malades Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Darren R', 'Initials': 'DR', 'LastName': 'Hargrave', 'Affiliation': 'Haematology and Oncology Department, Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'Adela', 'Initials': 'A', 'LastName': 'Cañete', 'Affiliation': 'Pediatric Oncology and Hematology Unit, Hospital La Fe, Valencia, Spain.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Massimino', 'Affiliation': 'Pediatric Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Amedeo A', 'Initials': 'AA', 'LastName': 'Azizi', 'Affiliation': 'Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Pediatric and Adolescent Oncology and Unite Mixte de Recherche, Gustave Roussy, Université Paris-Saclay, Université Paris-Sud, Villejuif, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Saran', 'Affiliation': 'Neuro-oncology Unit, Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'Rousseau', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Zahlmann', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Garcia', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': 'Pediatric and Adolescent Oncology and Unite Mixte de Recherche, Gustave Roussy, Université Paris-Saclay, Université Paris-Sud, Villejuif, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Grill', 'Affiliation': 'Pediatric and Adolescent Oncology and Unite Mixte de Recherche, Gustave Roussy, Université Paris-Saclay, Université Paris-Sud, Villejuif, France.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Morgan', 'Affiliation': 'Medical Physics and Clinical Engineering, Nottingham University Hospital Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Jaspan', 'Affiliation': 'Department of Radiology, Nottingham University Hospital Trust, Nottingham, United Kingdom.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3154']
183,32203980,Iron Chelation in Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes: A Randomized Trial.,"Background
Iron chelation therapy (ICT) in patients with lower-risk myelodysplastic syndromes (MDS) has not been evaluated in randomized studies.
Objective
To evaluate event-free survival (EFS) and safety of ICT in iron-overloaded patients with low- or intermediate-1-risk MDS.
Design
Multicenter, randomized, double-blind, placebo-controlled trial (TELESTO). (ClinicalTrials.gov: NCT00940602).
Setting
60 centers in 16 countries.
Participants
225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities.
Intervention
Deferasirox dispersible tablets (10 to 40 mg/kg per day) (n = 149) or matching placebo (n = 76).
Measurements
The primary end point was EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first.
Results
Median time on treatment was 1.6 years (interquartile range [IQR], 0.5 to 3.1 years) in the deferasirox group and 1.0 year (IQR, 0.6 to 2.0 years) in the placebo group. Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]). Adverse events occurred in 97.3% of deferasirox recipients and 90.8% of placebo recipients. Exposure-adjusted incidence rates of adverse events (≥15 events per 100 patient treatment-years) in deferasirox versus placebo recipients, respectively, were 24.7 versus 23.9 for diarrhea, 21.8 versus 18.7 for pyrexia, 16.7 versus 22.7 for upper respiratory tract infection, and 15.9 versus 0.9 for increased serum creatinine concentration.
Limitations
The protocol was amended from a phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants. There was differential follow-up between treatment groups.
Conclusion
The findings support ICT in iron-overloaded patients with low- to intermediate-1-risk MDS, with longer EFS compared with placebo and a clinically manageable safety profile. Therefore, ICT may be considered in these patients.
Primary Funding Source
Novartis Pharma AG.",2020,"Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]).","['Transfusion-Dependent Patients With Low- to Intermediate-1-Risk Myelodysplastic Syndromes', 'Participants\n\n\n225 patients with serum ferritin levels greater than 2247 pmol/L; prior receipt of 15 to 75 packed red blood cell units; and no severe cardiac, liver, or renal abnormalities', 'Setting\n\n\n60 centers in 16 countries', 'patients with lower-risk myelodysplastic syndromes (MDS', 'iron-overloaded patients with low- or intermediate-1-risk MDS', 'phase 3 to a phase 2 study, with a reduced target sample size from 630 to 210 participants']","['matching placebo', 'placebo', '\n\n\nIron chelation therapy (ICT', 'ICT', 'Iron Chelation']","['adverse events', 'EFS, defined as time from date of randomization to first documented nonfatal event (related to cardiac or liver dysfunction and transformation to acute myeloid leukemia) or death, whichever occurred first', 'Adverse events', 'serum creatinine concentration', 'Median EFS']","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439284', 'cui_str': 'fmol/mL'}, {'cui': 'C2316467', 'cui_str': ""Packed red blood cells (PRBC's)""}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0282193', 'cui_str': 'Iron Overload'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C4324477', 'cui_str': 'Transformation to acute myeloid leukaemia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",225.0,0.554516,"Median EFS was prolonged by approximately 1 year with deferasirox versus placebo (3.9 years [95% CI, 3.2 to 4.3 years] vs. 3.0 years [CI, 2.2 to 3.7 years], respectively; hazard ratio, 0.64 [CI, 0.42 to 0.96]).","[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Angelucci', 'Affiliation': 'Hematology and Transplant Center, IRCCS Ospedale Policlinico San Martino, Genova, Italy (E.A.).'}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China (J.L.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Greenberg', 'Affiliation': 'Stanford University Medical Center, Stanford, California (P.G.).'}, {'ForeName': 'Depei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Jiangsu Institute of Hematology, First Affiliated Hospital of Soochow University, Suzhou, China (D.W.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Shandong University, Jinan, China (M.H.).'}, {'ForeName': 'Efreen Horacio', 'Initials': 'EH', 'LastName': 'Montano Figueroa', 'Affiliation': 'Department of Hematology, Hospital General de México, Mexico City, Mexico (E.H.M.).'}, {'ForeName': 'Maria Guadalupe', 'Initials': 'MG', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology, Hospital de Especialidades, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico (M.G.R.).'}, {'ForeName': 'Xunwei', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (X.D., J.G.).'}, {'ForeName': 'Jagannath', 'Initials': 'J', 'LastName': 'Ghosh', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (X.D., J.G.).'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland (M.I.).'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'MD Anderson Cancer Center, University of Texas, Houston, Texas (G.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-0916']
184,32073660,"Ubrogepant, an Acute Treatment for Migraine, Improved Patient-Reported Functional Disability and Satisfaction in 2 Single-Attack Phase 3 Randomized Trials, ACHIEVE I and II.","OBJECTIVE
To evaluate the efficacy of ubrogepant on patient-reported functional disability, satisfaction with study medication, and global impression of change.
BACKGROUND
Ubrogepant is a small-molecule, oral calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine. In 2 phase 3 trials (ACHIEVE I and II), ubrogepant demonstrated efficacy vs placebo on the 2 co-primary endpoints of headache pain freedom and absence of the most bothersome migraine-associated symptom at 2 hours post dose for the 50 and 100 mg doses. Patient-reported outcomes, such as functional disability, satisfaction, and patient global impression of change, can provide additional evidence of the efficacy of an acute treatment for migraine on clinically meaningful and patient-relevant outcomes.
METHODS
ACHIEVE I and ACHIEVE II were multicenter, randomized, double-blind, placebo-controlled, parallel-group, single-attack trials in adults (18-75 years) with migraine. In ACHIEVE I, participants were randomized 1:1:1 to placebo or ubrogepant 50 or 100 mg; in ACHIEVE II, participants were randomized 1:1:1 to placebo or ubrogepant 25 or 50 mg to treat a migraine attack with moderate or severe headache pain. Participants rated ability to perform daily activities on the Functional Disability Scale, before dosing and at 1, 2, 4, and 8 hours after the initial dose; satisfaction with study medication at 2 and 24 hours; and impression of overall change in migraine on the Patient Global Impression of Change scale at 2 hours. In prespecified analyses for each trial, each outcome was compared between each ubrogepant dose group and the relevant placebo group. Data were pooled from the ubrogepant 50 mg and placebo groups of the 2 trials in a post hoc analysis.
RESULTS
In ACHIEVE I, 559 participants were randomized to placebo, 556 to ubrogepant 50 mg, and 557 to ubrogepant 100 mg; in ACHIEVE II, 563 were randomized to placebo, 561 to ubrogepant 25 mg, and 562 to ubrogepant 50 mg. At 2 hours post dose, significantly higher proportions of ubrogepant-treated participants vs placebo-treated participants reported being able to function normally (ACHIEVE I: ubrogepant 50 mg, 40.6% [171/421], P = .0012 vs placebo; ubrogepant 100 mg, 42.9% [192/448], P < .0001 vs placebo; placebo, 29.8% [136/456]; ACHIEVE II: ubrogepant 25 mg, 42.6% [185/434], P = .0015 vs placebo; ubrogepant 50 mg, 40.5% [188/464], P = .0118 vs placebo; placebo, 34.2% [156/456]; pooled 50 mg, 40.6% [359/885], vs pooled placebo, 32.0% [292/912]; P < .0001), were satisfied/extremely satisfied with study medication (ACHIEVE I: 50 mg, 36.3% [147/405], P < .0001 vs placebo; 100 mg, 35.8% [149/416], P = .0002 vs placebo; placebo, 24.1% [104/432]; ACHIEVE II: 25 mg, 35.1% [141/402], P = .0018 vs placebo; 50 mg, 37.8% [163/431], P < .0001 vs placebo; placebo, 24.8% [106/427]; pooled ubrogepant 50 mg, 37.1% [310/836], vs pooled placebo, 24.5% [210/859]; P < .0001), and indicated that their migraine was much/very much better on the Patient Global Impression of Change scale (ACHIEVE I: 50 mg, 34.4% [103/299], P = .0006 vs placebo; 100 mg, 34.3% [102/297], P = .0009 vs placebo; placebo, 22.0% [69/313]; ACHIEVE II: 25 mg, 34.1% [124/364], P < .0001 vs placebo; 50 mg, 33.4% [131/392], P = .0002 vs placebo; placebo, 20.7% [78/376]; pooled 50 mg, 33.9% [234/691], vs pooled placebo, 21.3% [147/689]; P < .0001).
CONCLUSIONS
A significantly higher proportion of participants treated with ubrogepant were able to function normally, were satisfied with the study medication, and reported clinically meaningful improvement compared with those receiving placebo. The results reinforce the potential benefits of ubrogepant on patient-centered outcomes in the acute treatment of migraine.",2020,"vs placebo; 50 mg, 33.4% [131/392], P = .0002","['559 participants', 'adults (18-75\xa0years) with migraine']","['placebo', 'placebo; placebo', 'placebo or ubrogepant 25 or 50\xa0mg to treat a migraine attack']","['functional disability, satisfaction, and patient global impression of change', 'headache pain freedom and absence of the most bothersome migraine-associated symptom', 'Functional Disability Scale', 'Functional Disability and Satisfaction', 'Patient Global Impression of Change scale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}]",559.0,0.685802,"vs placebo; 50 mg, 33.4% [131/392], P = .0002","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Rashmi B', 'Initials': 'RB', 'LastName': 'Halker Singh', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Anand R', 'Initials': 'AR', 'LastName': 'Shewale', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Sihui', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Sung Yun', 'Initials': 'SY', 'LastName': 'Yu', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Hema N', 'Initials': 'HN', 'LastName': 'Viswanathan', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}]",Headache,['10.1111/head.13766']
185,31985049,"A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects.","OBJECTIVE
To investigate and compare the safety and the pharmacokinetics of dihydroergotamine (DHE) after administration of intranasal DHE powder (STS101), intranasal DHE spray (Migranal ® ), and intramuscular (IM) DHE injection in healthy subjects.
METHODS
This was a 2-part, active-controlled, 3-period crossover study over 3 weeks, separated by 1-week washout periods. In part 1, 3 ascending dosage strengths of STS101 (1.3, 2.6, and 5.2 mg) were administered to 15 healthy subjects with no history of migraine. In part 2, 27 healthy subjects were administered 1 dose each of STS101 5.2 mg, Migranal DHE Mesylate Liquid Nasal Spray 2.0 mg, and IM DHE Mesylate 1.0 mg in a randomized order. Liquid chromatography, tandem mass spectrometry was used to determine plasma levels of DHE and its major metabolite, 8'OH-DHE. Pharmacokinetic parameters (C max , T max , AUC 0-2 h , AUC 0-48 h , AUC 0-inf , and t 1/2 ) for DHE and metabolite were calculated. Geometric means and 90% confidence intervals of log-transformed data were calculated and the ratio of means compared. Safety was evaluated by monitoring adverse events, vital signs, electrocardiograms, subjective and objective assessments of nasal signs and symptoms, and changes in laboratory parameters. The study is registered as NCT03874832.
RESULTS
Forty-three subjects were enrolled and received study medication. Forty completed all study activities, 14 in part 1 and 26 in part 2. In part 1, DHE plasma levels showed a dose-dependent increase, with STS101 5.2 mg reaching a mean C max of 1870 pg/mL with a T max of 23 minutes. In part 2, STS101 5.2 mg showed rapid absorption, achieving mean DHE plasma concentrations of 1230 and 1850 pg/mL at 10 and 15 minutes after administration, respectively. In comparison to Migranal, STS101 5.2 mg showed approximately 2-fold higher C max (2175 vs 961 pg/mL), AUC 0-2 h (2979 vs 1316 h × pg/mL), and AUC 0-inf (12,030 vs 6498 h × pg/mL), respectively. The mean AUC 0-inf of STS101 5.2 mg was comparable to IM DHE (12,030 vs 13,650 h × pg/mL). STS101 5.2 mg showed substantially lower variability compared to Migranal for C max (41% vs 76%), AUC 0-2 h (39% vs 75%), and AUC 0-inf (39% vs 55%). The incidence of treatment emergent AEs (TEAEs), all mild and transient, reported in parts 1 and 2 combined was 9/15 (60%), 5/15 (33%), and 16/41 (39%) of the subjects after 1.3, 2.6, and 5.2 mg STS101, respectively, and 4/26 (15%) and 5/27 (19%) of the subjects after IM DHE and Migranal, respectively.
CONCLUSION
STS101 showed rapid absorption, achieving effective DHE plasma concentrations within 10 minutes. It achieved substantially higher C max , AUC 0-2 h and AUC 0-inf , compared to Migranal suggesting potentially better efficacy than Migranal. Its variability was better than Migranal, thus offering improved consistency of response. AUC 0-inf was comparable to IM DHE, suggesting prolonged action and low recurrence. Additionally, the C max was sufficiently low to avoid any significant nausea reported with IV DHE. Thus, STS101 is an easy to administer, non-injected, acute treatment for migraine, with a favorable tolerability profile and is expected to provide rapid and consistent freedom from pain and associated migraine symptoms without recurrence.",2020,"It achieved substantially higher C max , AUC 0-2 h and AUC 0-inf , compared to Migranal suggesting potentially better efficacy than Migranal.","['Forty completed all study activities, 14 in part 1 and 26 in part 2', '15 healthy subjects with no history of migraine', 'healthy subjects', '27 healthy subjects', 'Forty-three subjects were enrolled and received study medication', 'Healthy Adult Subjects']","['IM DHE', 'STS101 5.2\xa0mg, Migranal DHE Mesylate Liquid Nasal Spray 2.0\xa0mg, and IM DHE Mesylate', 'dihydroergotamine (DHE', 'Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray', 'intranasal DHE powder (STS101), intranasal DHE spray (Migranal ® ), and intramuscular (IM) DHE injection']","['DHE plasma levels', 'rapid absorption, achieving effective DHE plasma concentrations', 'Pharmacokinetic parameters (C max , T max , AUC 0-2', 'rapid absorption, achieving mean DHE plasma concentrations', 'monitoring adverse events, vital signs, electrocardiograms, subjective and objective assessments of nasal signs and symptoms, and changes in laboratory parameters']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1271043', 'cui_str': 'No history of migraine'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0643690', 'cui_str': 'DHED'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0086157', 'cui_str': 'Migranal'}, {'cui': 'C3645051', 'cui_str': 'mesylate'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0012291', 'cui_str': 'Dihydroergotamine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0700532', 'cui_str': 'Dihydroergotamine Mesylate'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0643690', 'cui_str': 'DHED'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",15.0,0.025302,"It achieved substantially higher C max , AUC 0-2 h and AUC 0-inf , compared to Migranal suggesting potentially better efficacy than Migranal.","[{'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Albrecht', 'Affiliation': 'Satsuma Pharmaceuticals Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Mic', 'Initials': 'M', 'LastName': 'Iwashima', 'Affiliation': 'Satsuma Pharmaceuticals Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Dillon', 'Affiliation': 'Satsuma Pharmaceuticals Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Seaview/Quotient, Miami, FL, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Seaview/Quotient, Miami, FL, USA.'}]",Headache,['10.1111/head.13737']
186,32289824,Exposure to Odors Increases Pain Threshold in Chronic Low Back Pain Patients.,"OBJECTIVES
Structured exposure to odors is an acknowledged therapy in patients with smell loss but has also been shown to be effective in depression. The latter might rely on connections between olfactory and emotional structures, suggesting possible effects of a similar approach in pain patients. Based on neuroanatomy, there are several interfaces between the ""pain matrix"" and olfactory system, such as the limbic system, hypothalamus, and mediodorsal thalamus. We aimed to investigate whether structured exposure to odors may impact perceived pain in patients with chronic low back pain.
DESIGN
Randomized controlled parallel-group design. Subjects were tested on two occasions, at baseline and after four weeks.
SETTING
Ambulatory.
SUBJECTS
Forty-two patients with chronic low back pain.
METHODS
For all patients, olfactory function (using the ""Sniffin'Sticks"" test kit), detection, and pain thresholds for cutaneous electrical stimuli (applied to the forearm) were tested at baseline and after four weeks. Twenty-eight patients exposed themselves to four odors (rose, vanilla, chocolate, peach) every two hours over a period of four weeks (training group). Control patients (N = 14) underwent no such ""olfactory training"" (nontraining group).
RESULTS
Pain thresholds were significantly increased in patients who performed olfactory training compared with patients who did not train with odors. Detection thresholds and olfactory function remained unchanged.
CONCLUSIONS
The present results indicate that regular exposure to odors increases pain thresholds in patients with chronic back pain and could be useful for general pain control in these patients. Furthermore, olfactory training in chronic pain patients might help to reduce chronification of pain by desensitization.",2020,"Twenty-eight patients exposed themselves to four odors (rose, vanilla, chocolate, peach) every two hours over a period of four weeks (training group).","['Forty-two patients with chronic low back pain', 'patients with smell loss', 'pain patients', 'Chronic Low Back Pain Patients', 'patients with chronic low back pain', 'Control patients (N\u2009=\u200914) underwent', 'chronic pain patients', 'patients with chronic back pain']","['olfactory training', 'no such ""olfactory training"" (nontraining group']","['pain thresholds', 'Pain thresholds', 'Detection thresholds and olfactory function']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}]","[{'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",42.0,0.0246577,"Twenty-eight patients exposed themselves to four odors (rose, vanilla, chocolate, peach) every two hours over a period of four weeks (training group).","[{'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Gossrau', 'Affiliation': 'University Pain Center, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Baum', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine Carl Gustav Carus, University Hospital, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Sabatowski', 'Affiliation': 'University Pain Center, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hummel', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Haehner', 'Affiliation': 'Smell & Taste Clinic, Department of Otorhinolaryngology, TU Dresden, Dresden, Germany.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa072']
187,32289696,Effectiveness of cathodal tDCS of the primary motor or sensory cortex in migraine: A randomized controlled trial.,"OBJECTIVES
Transcranial Direct Current Stimulation (tDCS) is a new technology that is extensively used for migraine treatment. The present study aims to examine the effectiveness of cathodal-tDCS (c-tDCS) in decreasing migraine pain frequency, duration, and intensity at the right primary motor cortex (M 1 ) or sensory cortex (S 1 ) in individuals with episodic or chronic migraine.
METHODS
The present study has a randomized, single-blind, and sham-controlled design. It tests the effectiveness of 22 sessions of c-tDCS (20min/1000 μA) in 45 migraine patients (episodic = 35; chronic = 10/with aura = 28; without aura = 17). Spread over 10 consecutive weeks, the sessions started with three sessions per week and ended with one session per week. Participants were tested at the baseline, at the end of intervention, and at 12-month follow-up. The migraine diagnosis was based on criteria set by International Headache Society (IHS) and patients were allocated to two experimental (n m1 = 15; n s1 = 15) and a sham intervention group (n c = 15).
RESULTS
The results of a series of MANCOVAs showed a significant reduction (p < 0.05) in all hypothesized symptoms of migraine pain in both experimental groups compared to the sham intervention group at the posttest and follow-up.
CONCLUSION
The application of c-tDCS to M 1 or S 1 can be used as a technological intervention for the prophylactic and therapeutic treatment of episodic or chronic migraine.
ETHICAL COMMITTEE REGISTRATION NUMBER
Ir.mums.fm.rec.1396.362.",2020,"The results of a series of MANCOVAs showed a significant reduction (p < 0.05) in all hypothesized symptoms of migraine pain in both experimental groups compared to the sham intervention group at the posttest and follow-up.
","['individuals with episodic or chronic migraine', 'migraine', '45 migraine patients (episodic\xa0=\xa035; chronic\xa0=\xa010/with aura\xa0=\xa028; without aura\xa0=\xa017']","['cathodal-tDCS (c-tDCS', 'cathodal tDCS', 'c-tDCS (20min/1000\xa0μA', 'Transcranial Direct Current Stimulation (tDCS']","['migraine pain frequency, duration, and intensity at the right primary motor cortex (M 1 ) or sensory cortex (S 1 ', 'migraine pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0236018', 'cui_str': 'Aura'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0528520', 'cui_str': 'M-1 compound'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]",45.0,0.0293464,"The results of a series of MANCOVAs showed a significant reduction (p < 0.05) in all hypothesized symptoms of migraine pain in both experimental groups compared to the sham intervention group at the posttest and follow-up.
","[{'ForeName': 'Mohammad Dawood', 'Initials': 'MD', 'LastName': 'Rahimi', 'Affiliation': 'School of Education and Psychology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Javad Salehi', 'Initials': 'JS', 'LastName': 'Fadardi', 'Affiliation': 'School of Education and Psychology, Ferdowsi University of Mashhad, Mashhad, Iran; School of Community and Global Health, Claremont Graduate University, USA; School of Psychology, Bangor University, UK. Electronic address: j.s.fadardi@um.ac.ir.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Saeidi', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Imanolla', 'Initials': 'I', 'LastName': 'Bigdeli', 'Affiliation': 'School of Education and Psychology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Rohollah', 'Initials': 'R', 'LastName': 'Kashiri', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Brain stimulation,['10.1016/j.brs.2020.02.012']
188,32291309,Physiologic Effects of High-Flow Nasal Cannula in Healthy Subjects.,"BACKGROUND
High-flow nasal cannula (HFNC) is increasingly used in the management of acute and chronic respiratory failure. Little is known about the optimal settings for HFNC. This study was designed to assess the dose effect of HFNC on respiratory effort indexes and respiratory patterns in spontaneously breathing adults.
METHODS
A randomized controlled crossover study was conducted in 10 healthy subjects. Five experimental conditions were evaluated: baseline with no therapy; 5 L/min with conventional nasal prongs; and HFNC at 20, 40, and 60 L/min. The primary outcomes were the indexes of respiratory effort (ie, esophageal pressure swing [ΔP es ], esophageal pressure-time product, and work of breathing). Secondary outcomes included breathing pattern parameters and blood gases. Dead-space ventilation and washout were calculated based on minute ventilation, breathing frequency, and Radford equations.
RESULTS
ΔP es increased from median (interquartile range [IQR] 3.2 (2.2-3.6) cm H 2 O at baseline to median (IQR) 5.7 (4.6-6.8) cm H 2 O at 60 L/min ( P < .001). Neither esophageal pressure-time product nor work of breathing were modified during the tested conditions. The minute volume was significantly reduced at 40 and 60 L/min compared with baseline (P = .04), mostly driven by an important and dose-dependent reduction in breathing frequency, from median (IQR) 16 (15-18) breaths/min at baseline, to median (IQR) 8 (7-10) breaths/min at 60 L/min ( P < .001). Capillary [Formula: see text] was stable in all the tested conditions. The calculated dead-space ventilation was reduced by half with HFNC.
CONCLUSIONS
HFNC did not significantly modify work of breathing in healthy subjects. However, a significant reduction in the minute volume was achieved, capillary [Formula: see text] remaining constant, which suggests a reduction in dead-space ventilation with flows > 20 L/min. (ClinicalTrials.gov registration NCT02495675).",2020,"The minute volume was significantly reduced at 40 and 60 L/min compared with baseline ( P = .04), mostly driven by an important and dose-dependent reduction in breathing frequency, from median (IQR) 16 (15-18) breaths/min at baseline, to median (IQR) 8 (7-10) breaths/min at 60 L/min ( P < .001).","['Healthy Subjects', 'spontaneously breathing adults', '10 healthy subjects', 'healthy subjects']","['High-flow nasal cannula (HFNC', 'HFNC', 'High-Flow Nasal Cannula']","['esophageal pressure-time product nor work of breathing', 'minute volume', 'calculated dead-space ventilation', 'breathing frequency', 'breathing pattern parameters and blood gases', 'indexes of respiratory effort (ie, esophageal pressure swing [ΔP es ], esophageal pressure-time product, and work of breathing']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0428679', 'cui_str': 'Minute volume'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0425466', 'cui_str': 'Respiratory effort'}]",10.0,0.0710847,"The minute volume was significantly reduced at 40 and 60 L/min compared with baseline ( P = .04), mostly driven by an important and dose-dependent reduction in breathing frequency, from median (IQR) 16 (15-18) breaths/min at baseline, to median (IQR) 8 (7-10) breaths/min at 60 L/min ( P < .001).","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Delorme', 'Affiliation': 'Université Paris-Saclay, UVSQ, ERPHAN, Versailles, France.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bouchard', 'Affiliation': ""Centre de Recherche de l'Institut, Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada.""}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Simon', 'Affiliation': ""Centre de Recherche de l'Institut, Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Simard', 'Affiliation': ""Centre de Recherche de l'Institut, Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lellouche', 'Affiliation': ""Centre de Recherche de l'Institut, Universitaire de Cardiologie et de Pneumologie de Québec, Québec, Canada. francois.lellouche@criucpq.ulaval.ca.""}]",Respiratory care,['10.4187/respcare.07306']
189,32289853,"A prospective, randomized trial of thrombin versus cyanoacrylate injection in the control of acute gastric variceal hemorrhage.","BACKGROUND
Acute gastric variceal hemorrhage (AGVH) is a serious complication of portal hypertension. Endoscopic cyanoacrylate glue injection is standard therapy for acute hemostasis; however, it may be associated with serious complications. The role of thrombin injection has not been confirmed. This study compared endoscopic thrombin and glue injections in the hemostasis of AGVH.
METHODS
68 eligible patients with AGVH were randomized to receive thrombin injection (33 patients) or glue injection (35 patients). The primary end point was injection-induced gastric ulcers. Secondary end points were acute hemostasis, rebleeding, and mortality within 42 days.
RESULTS
Both groups had comparable baseline data. Hemostasis of active bleeding at endoscopy was 90.0 % (9/10) in the thrombin group and 90.9 % (10/11) in the glue group ( P = 0.58), and 48-hour hemostasis was achieved in 93.9 % (31/33) and 97.1 % (34/35), respectively ( P = 0.60). Treatment failure at 5 days occurred in two patients (6.1 %) in the thrombin group and two patients (5.7 %) in the glue group ( P > 0.99). Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P < 0.001, 95 % confidence interval [CI] 8 % - 27 %). Complications occurred in 4 (12.1 %) and 18 (51.4 %) patients in the thrombin and glue groups, respectively ( P < 0.001, 95 %CI 22 % - 45 %). Two patients who received glue had post-treatment gastric ulcer bleeding. One patient in each group died.
CONCLUSIONS
Endoscopic thrombin injection was similar to glue injection in achieving successful hemostasis of AGVH. However, a higher incidence of complications may be associated with glue injection.",2020,"Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P < 0.001, 95 % confidence interval [CI] 8 % - 27 %).","['acute gastric variceal hemorrhage', 'acute hemostasis', 'Acute gastric variceal hemorrhage (AGVH', 'Two patients who received glue had post-treatment gastric ulcer bleeding', '68 eligible patients with AGVH']","['glue injection', 'cyanoacrylate injection', 'thrombin', 'Endoscopic cyanoacrylate glue injection', 'Endoscopic thrombin injection', 'endoscopic thrombin and glue injections', 'thrombin injection']","['Treatment failure', '48-hour hemostasis', 'acute hemostasis, rebleeding, and mortality within 42 days', 'Complications', 'Gastric ulcers', 'injection-induced gastric ulcers', 'Hemostasis of active bleeding at endoscopy']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0333106', 'cui_str': 'Bleeding varices'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}]","[{'cui': 'C0017780', 'cui_str': 'Glue'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylate'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",68.0,0.126385,"Gastric ulcers occurred in none of the thrombin group and 11/30 (36.7 %) of the glue group ( P < 0.001, 95 % confidence interval [CI] 8 % - 27 %).","[{'ForeName': 'Gin-Ho', 'Initials': 'GH', 'LastName': 'Lo', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chih-Wen', 'Initials': 'CW', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Chi-Ming', 'Initials': 'CM', 'LastName': 'Tai', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Daw-Shyong', 'Initials': 'DS', 'LastName': 'Perng', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'I-Lin', 'Initials': 'IL', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Jen-Hao', 'Initials': 'JH', 'LastName': 'Yeh', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Research, Division of Gastroenterology, E-DA Hospital, Kaohsiung, Taiwan.'}]",Endoscopy,['10.1055/a-1127-3170']
190,32291277,Effects of Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide on Biomarkers of Nonalcoholic Steatohepatitis in Patients With Type 2 Diabetes.,"OBJECTIVE
To determine the effect of tirzepatide, a dual agonist of glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 receptors, on biomarkers of nonalcoholic steatohepatitis (NASH) and fibrosis in patients with type 2 diabetes mellitus (T2DM).
RESEARCH DESIGN AND METHODS
Patients with T2DM received either once weekly tirzepatide (1, 5, 10, or 15 mg), dulaglutide (1.5 mg), or placebo for 26 weeks. Changes from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST), keratin-18 (K-18), procollagen III (Pro-C3), and adiponectin were analyzed in a modified intention-to-treat population.
RESULTS
Significant ( P < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks. Decreases with tirzepatide were significant compared with placebo for K-18 (10 mg) and Pro-C3 (15 mg) and with dulaglutide for ALT (10, 15 mg). Adiponectin significantly increased from baseline with tirzepatide compared with placebo (10, 15 mg).
CONCLUSIONS
In post hoc analyses, higher tirzepatide doses significantly decreased NASH-related biomarkers and increased adiponectin in patients with T2DM.",2020,"RESULTS
Significant ( P < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks.","['patients with T2DM', 'Patients With Type 2 Diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with T2DM received either once weekly']","['tirzepatide', 'placebo', 'dulaglutide', 'Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide', 'AST']","['NASH-related biomarkers and increased adiponectin', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), keratin-18 (K-18), procollagen III (Pro-C3), and adiponectin', 'Adiponectin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0071997', 'cui_str': 'Pro-Complement 3'}]",,0.0602816,"RESULTS
Significant ( P < 0.05) reductions from baseline in ALT (all groups), AST (all groups except tirzepatide 10 mg), K-18 (tirzepatide 5, 10, 15 mg), and Pro-C3 (tirzepatide 15 mg) were observed at 26 weeks.","[{'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hartman', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN hartman_mark_l@lilly.com.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Department of Medicine, University of California, San Diego, La Jolla, CA.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Wilson', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nikooienejad', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bray', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Chrisanthi A', 'Initials': 'CA', 'LastName': 'Karanikas', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Kevin L', 'Initials': 'KL', 'LastName': 'Duffin', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Robins', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}]",Diabetes care,['10.2337/dc19-1892']
191,32170727,Smoking cessation prior to gynecological surgery-A registry-based randomized trial.,"INTRODUCTION
Smoking cessation, both pre- and postoperatively, is important to reduce complications associated with surgery. Identifying feasible and effective means of alerting the patient before surgery to the importance of perioperative smoking cessation is a challenge to healthcare systems.
MATERIAL AND METHODS
A randomized registry-based trial using the web-version of the Swedish national quality register for gynecological surgery, GynOp, was performed (ClinicalTrials.gov NCT03942146). Current smokers scheduled for gynecological surgery were randomly assigned before surgery to group 1 (control group, no specific information), group 2 (web-based written information), group 3 (information to doctor that the woman was a smoker and should be recommended smoking cessation or group 4 (a combination of groups 2 and 3). Perioperative smoking habits were evaluated in a postoperative questionnaire 2 months after surgery. The treatment effect was estimated to be a 15% reduction in the number of smokers at the time of surgery. Thus, 94 women in each group were required, in total 376 women, using a one-sided test with an alpha level of 0.001 and a statistical power of 80%.
RESULTS
Participants (n = 1427) were recruited between 5 November 2015 and 6 December 2017. A total of 1137 smokers responded to the follow-up questionnaire (80%), with 486 women declining to participate, leaving 651 women eligible for analysis. Women who received both web-based information prior to surgery and information from a doctor, reported smoking cessation more often from 1 to 3 weeks preoperatively (Odds ratio [OR] 1.8, 95% confidence interval [CI] 1.0-3.3) and 1 to 3 weeks after surgery (OR 1.9, 95% CI 1.1-3.3) compared with the control group who received no specific information.
CONCLUSIONS
A combination of written information in the health declaration and a recommendation from a doctor regarding smoking cessation may be associated with higher odds of smoking cessation at 1-3 weeks pre- and postoperatively.",2020,"Women who received both web-based information prior to surgery and information from a doctor reported smoking cessation more often from 1-3 weeks preoperatively (Odds ratio, 95% confidence interval 1.8 [1.0-3.3]) and 1-3 weeks after surgery (1.9 [1.1-3.3]) compared to the control group who received no specific information.
","['1137 smokers responded to the follow-up questionnaire (80%) and 486 women declined participation leaving 651 women eligible for analysis', '94 women in each group were required, in total 376 women, using a one-sided test with an alfa level of 0.001 and a statistical power of 80', 'Current smokers scheduled for gynecological surgery', 'Participants (n = 1427) were recruited between November 5, 2015, and December 6, 2017']","['control group, no specific information, Group 2, web-based written information, Group 3, information to doctor that the woman was a smoker and should be recommended smoking cessation', 'Smoking cessation prior to gynecological surgery']","['smoking cessation', 'Perioperative smoking habits']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C3241966'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}]",1427.0,0.0572988,"Women who received both web-based information prior to surgery and information from a doctor reported smoking cessation more often from 1-3 weeks preoperatively (Odds ratio, 95% confidence interval 1.8 [1.0-3.3]) and 1-3 weeks after surgery (1.9 [1.1-3.3]) compared to the control group who received no specific information.
","[{'ForeName': 'Katja S', 'Initials': 'KS', 'LastName': 'Bohlin', 'Affiliation': 'Department of Obstetrics and Gynecology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Löfgren', 'Affiliation': 'Department of Obstetrics and Gynecology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Lindkvist', 'Affiliation': 'Department of Mathematics and Mathematical Statistics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Milsom', 'Affiliation': 'Department of Obstetrics and Gynecology, Sahlgrenska Academy at Gothenburg University, Gothenburg, Sweden.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13843']
192,32268027,Physical Therapy versus Glucocorticoid Injection for Osteoarthritis of the Knee.,"BACKGROUND
Both physical therapy and intraarticular injections of glucocorticoids have been shown to confer clinical benefit with respect to osteoarthritis of the knee. Whether the short-term and long-term effectiveness for relieving pain and improving physical function differ between these two therapies is uncertain.
METHODS
We conducted a randomized trial to compare physical therapy with glucocorticoid injection in the primary care setting in the U.S. Military Health System. Patients with osteoarthritis in one or both knees were randomly assigned in a 1:1 ratio to receive a glucocorticoid injection or to undergo physical therapy. The primary outcome was the total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 1 year (scores range from 0 to 240, with higher scores indicating worse pain, function, and stiffness). The secondary outcomes were the time needed to complete the Alternate Step Test, the time needed to complete the Timed Up and Go test, and the score on the Global Rating of Change scale, all assessed at 1 year.
RESULTS
We enrolled 156 patients with a mean age of 56 years; 78 patients were assigned to each group. Baseline characteristics, including severity of pain and level of disability, were similar in the two groups. The mean (±SD) baseline WOMAC scores were 108.8±47.1 in the glucocorticoid injection group and 107.1±42.4 in the physical therapy group. At 1 year, the mean scores were 55.8±53.8 and 37.0±30.7, respectively (mean between-group difference, 18.8 points; 95% confidence interval, 5.0 to 32.6), a finding favoring physical therapy. Changes in secondary outcomes were in the same direction as those of the primary outcome. One patient fainted while receiving a glucocorticoid injection.
CONCLUSIONS
Patients with osteoarthritis of the knee who underwent physical therapy had less pain and functional disability at 1 year than patients who received an intraarticular glucocorticoid injection. (ClinicalTrials.gov number, NCT01427153.).",2020,The mean (±SD) baseline WOMAC scores were 108.8±47.1 in the glucocorticoid injection group and 107.1±42.4 in the physical therapy group.,"['Patients with osteoarthritis of the knee who underwent', 'Patients with osteoarthritis in one or both knees', 'primary care setting in the U.S. Military Health System', '156 patients with a mean age of 56 years; 78 patients', 'Osteoarthritis of the Knee']","['Physical Therapy versus Glucocorticoid Injection', 'physical therapy with glucocorticoid injection', 'glucocorticoids', 'glucocorticoid injection', 'glucocorticoid injection or to undergo physical therapy', 'intraarticular glucocorticoid injection', 'physical therapy']","['severity of pain and level of disability', 'time needed to complete the Alternate Step Test, the time needed to complete the Timed Up and Go test, and the score on the Global Rating of Change scale', 'mean (±SD) baseline WOMAC scores', 'mean scores', 'total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC', 'pain and functional disability', 'pain, function, and stiffness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0230434', 'cui_str': 'Both knees'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C5197818', 'cui_str': 'Military Health System'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",156.0,0.0725309,The mean (±SD) baseline WOMAC scores were 108.8±47.1 in the glucocorticoid injection group and 107.1±42.4 in the physical therapy group.,"[{'ForeName': 'Gail D', 'Initials': 'GD', 'LastName': 'Deyle', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Chris S', 'Initials': 'CS', 'LastName': 'Allen', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Allison', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Norman W', 'Initials': 'NW', 'LastName': 'Gill', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Hando', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Evan J', 'Initials': 'EJ', 'LastName': 'Petersen', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Douglas I', 'Initials': 'DI', 'LastName': 'Dusenberry', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Rhon', 'Affiliation': 'From Brooke Army Medical Center (G.D.D., S.C.A., N.W.G., D.I.D., D.I.R.), the Special Warfare Training Wing, U.S. Air Force (B.R.H.), and the University of the Incarnate Word (E.J.P.) - all in San Antonio, TX; the College of Allied Health Sciences, University of Cincinnati, Cincinnati (C.S.A.); and Madigan Army Medical Center, Tacoma, WA (D.I.R.).'}]",The New England journal of medicine,['10.1056/NEJMoa1905877']
193,32227753,Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease.,"BACKGROUND
In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.
METHODS
We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.
RESULTS
At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).
CONCLUSIONS
In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","['Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease', 'patients with stable ischemic heart disease and moderate or severe ischemia']",['invasive treatment strategy (2295 participants) or a conservative strategy'],"['angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ', 'SAQ summary score (scores range', 'SAQ summary scores', 'angina-related health status']","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}]",,0.248293,"SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy.","[{'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Jones', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Weintraub', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Khaula', 'Initials': 'K', 'LastName': 'Baloch', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916370']
194,32051147,Novel Detection and Restorative Levodopa Treatment for Preclinical Diabetic Retinopathy.,"Diabetic retinopathy (DR) is diagnosed clinically by directly viewing retinal vascular changes during ophthalmoscopy or through fundus photographs. However, electroretinography (ERG) studies in humans and rodents have revealed that retinal dysfunction is demonstrable prior to the development of visible vascular defects. Specifically, delays in dark-adapted ERG oscillatory potential (OP) implicit times in response to dim-flash stimuli (<-1.8 log cd · s/m 2 ) occur prior to clinically recognized DR. Animal studies suggest that retinal dopamine deficiency underlies these early functional deficits. In this study, we randomized individuals with diabetes, without clinically detectable retinopathy, to treatment with either low- or high-dose Sinemet (levodopa plus carbidopa) for 2 weeks and compared their ERG findings with those of control subjects (no diabetes). We assessed dim-flash-stimulated OP delays using a novel handheld ERG system (RETeval) at baseline and 2 and 4 weeks. RETeval recordings identified significant OP implicit time delays in individuals with diabetes without retinopathy compared with age-matched control subjects ( P < 0.001). After 2 weeks of Sinemet treatment, OP implicit times were restored to control values, and these improvements persisted even after a 2-week washout. We conclude that detection of dim-flash OP delays could provide early detection of DR and that Sinemet treatment may reverse retinal dysfunction.",2020,RETeval recordings identified significant OP implicit-time delays in persons with diabetes without retinopathy compared to age-matched control s (p<0.001).,"['persons with diabetes without retinopathy', 'persons with diabetes, without clinically detectable retinopathy, to treatment with either low or high dose Sinemet (levodopa plus carbidopa) for 2 weeks and compared their ERG findings with those of control (no DM) subjects', 'Pre-Clinical Diabetic Retinopathy']",['Novel Detection and Restorative Levodopa Treatment'],"['Diabetic retinopathy (DR', 'OP implicit-time delays', 'delays in dark-adapted ERG oscillatory potential (OP) implicit times', 'OP implicit times']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0074559', 'cui_str': 'Sinemet'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332582', 'cui_str': 'Dark color (qualifier value)'}]",,0.0177311,RETeval recordings identified significant OP implicit-time delays in persons with diabetes without retinopathy compared to age-matched control s (p<0.001).,"[{'ForeName': 'Cara T', 'Initials': 'CT', 'LastName': 'Motz', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Kyle C', 'Initials': 'KC', 'LastName': 'Chesler', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Rachael S', 'Initials': 'RS', 'LastName': 'Allen', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Bales', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Lukas M', 'Initials': 'LM', 'LastName': 'Mees', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Feola', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'April Y', 'Initials': 'AY', 'LastName': 'Maa', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA.'}, {'ForeName': 'Darin E', 'Initials': 'DE', 'LastName': 'Olson', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, GA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Thule', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, GA.'}, {'ForeName': 'P Michael', 'Initials': 'PM', 'LastName': 'Iuvone', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, GA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Hendrick', 'Affiliation': 'Department of Ophthalmology, Emory University, Atlanta, GA.'}, {'ForeName': 'Machelle T', 'Initials': 'MT', 'LastName': 'Pardue', 'Affiliation': 'Center for Visual and Neurocognitive Rehabilitation, Atlanta Veterans Affairs Medical Center, Decatur, GA machelle.pardue@bme.gatech.edu.'}]",Diabetes,['10.2337/db19-0869']
195,31399773,Cost differences between digital tomosynthesis and standard digital mammography in a breast cancer screening programme: results from the To-Be trial in Norway.,"BACKGROUND
Several studies in Europe and the US have shown promising results favouring digital breast tomosynthesis compared to standard digital mammography (DM). However, the costs of implementing the technology in screening programmes are not yet known.
METHODS
A randomised controlled trial comparing the results from digital breast tomosynthesis including synthetic mammograms (DBT) vs. DM was performed in Bergen during 2016 and 2017 as a part of BreastScreen Norway. The trial included 29,453 women and allowed for a detailed comparison of procedure use and screening, recall and treatment costs estimated at the individual level.
RESULTS
The increased cost of equipment, examination and reading time with DBT vs. DM was €8.5 per screened woman (95% CI 8.4-8.6). Costs of DBT remained significantly higher after adding recall assessment costs, €6.2 (95% CI 4.6-7.9). Substantial reductions in either examination and reading times, price of DBT equipment or price of IT storage and connectivity did not change the conclusion. Adding treatment costs resulted in too wide confidence intervals to draw definitive conclusions (additional costs of tomosynthesis €9.8, 95% CI -56 to 74). Performing biopsy at recall, radiation therapy and chemotherapy was significantly more frequent among women screened with DBT.
CONCLUSION
The results showed lower incremental costs of DBT vs. DM, compared to what is found in previous cost analyses of DBT and DM. However, the incremental costs were still higher for DBT compared with DM after including recall costs. Further studies with long-term treatment data are needed to understand the complete costs of implementing DBT in screening.",2019,"Substantial reductions in either examination and reading times, price of DBT equipment or price of IT storage and connectivity did not change the conclusion.","['Bergen during 2016 and 2017 as a part of BreastScreen Norway', '29,453 women and allowed for a detailed comparison of procedure use and screening, recall and treatment costs estimated at the individual level']","['digital tomosynthesis and standard digital mammography', 'digital breast tomosynthesis including synthetic mammograms (DBT) vs. DM', 'standard digital mammography (DM']","['price of DBT equipment or price of IT storage and connectivity', 'incremental costs of DBT vs. DM', 'Costs of DBT', 'cost of equipment, examination and reading time with DBT vs. DM']","[{'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C3472347', 'cui_str': 'Breast Tomosyntheses, X-ray'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}]","[{'cui': 'C0080045', 'cui_str': 'Prices'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.167691,"Substantial reductions in either examination and reading times, price of DBT equipment or price of IT storage and connectivity did not change the conclusion.","[{'ForeName': 'Tron Anders', 'Initials': 'TA', 'LastName': 'Moger', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway. tronmo@medisin.uio.no.'}, {'ForeName': 'Jayson O', 'Initials': 'JO', 'LastName': 'Swanson', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Åsne Sørlien', 'Initials': 'ÅS', 'LastName': 'Holen', 'Affiliation': 'Cancer Registry of Norway, Oslo, Norway.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Hanestad', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Hofvind', 'Affiliation': 'Cancer Registry of Norway, Oslo, Norway.'}]",The European journal of health economics : HEPAC : health economics in prevention and care,['10.1007/s10198-019-01094-7']
196,32284266,Identification of the major allergenic proteins from silkworm moth (Bombyx mori) involved in respiratory allergic diseases.,"INTRODUCTION AND OBJECTIVES
Moths are a significant source of indoor and outdoor aeroallergens. High prevalence of IgE-mediated sensitization was demonstrated in a group of patients with allergic respiratory diseases. There are no studies on adult stage of these moth species allergens involved in allergic respiratory reactions - the aim of this study.
MATERIAL AND METHODS
36 participants were included in an experimental study, submitted to skin prick test with Bombyx mori wing extract and six other common allergens, as well as Western blot analysis with incubated nitrocellulose membrane impregnated with silkworm moth extract and human IgE-antibody. The participants were divided into 3 groups: 1) 21 allergic patients whose skin prick test was positive to Bombyx mori wing extract, 2) eight allergic patients whose skin prick test was positive to mite and negative to Bombyx mori extract 3) seven negative non-allergic subjects.
RESULTS
Among the 21 participants from group 1, 19 serum samples reacted to Bombyx mori extract by Western blot. All of them reacted to a protein at 80 kDa and five other proteins (66, 50, 45, 37 and 30 kDa) were identified in more than 50% of the individuals tested, considered as major allergenic proteins. Sera from seven out of eight patients sensitized to house dust mite demonstrated IgE-reactivity to Bombyx mori extract by Western blot analysis. Serum samples from healthy participants did not react at all.
CONCLUSION
Six major reactive proteins by immunoblot analysis from moth's wings sensitized patients can be potential allergens. The one at 80 kDa is the major protein, seen in all IgE-reactive patients from group 1 and in none from group 2, yet to be identified. Future studies should be conducted to better characterize these proteins.",2020,Sera from seven out of eight patients sensitized to house dust mite demonstrated IgE-reactivity to Bombyx mori extract by Western blot analysis.,"['36 participants were included in an experimental study, submitted to skin prick test with', 'participants were divided into 3 groups: 1) 21 allergic patients whose', 'patients with allergic respiratory diseases', '21 participants from group 1, 19 serum samples reacted to Bombyx mori extract by Western blot']","['Bombyx mori wing extract and six other common allergens, as well as Western blot analysis with incubated nitrocellulose membrane impregnated with silkworm moth extract and human IgE-antibody', 'skin prick test was positive to Bombyx mori wing extract, 2) eight allergic patients whose skin prick test was positive to mite and negative to Bombyx mori extract 3) seven negative non-allergic subjects']",[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1504369', 'cui_str': 'Allergic disorder of respiratory system'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0323309', 'cui_str': 'Bombyx mori'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0005863', 'cui_str': 'Western Blotting'}]","[{'cui': 'C0323309', 'cui_str': 'Bombyx mori'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0949466', 'cui_str': 'Western blot assay'}, {'cui': 'C0600190', 'cui_str': 'Nitrocellulose'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0037119', 'cui_str': 'Bombyx'}, {'cui': 'C0023338', 'cui_str': 'Order Lepidoptera'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026231', 'cui_str': 'Mite'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205453', 'cui_str': '7'}]",[],36.0,0.0182703,Sera from seven out of eight patients sensitized to house dust mite demonstrated IgE-reactivity to Bombyx mori extract by Western blot analysis.,"[{'ForeName': 'Laura M L', 'Initials': 'LML', 'LastName': 'Araujo', 'Affiliation': 'Programa de Pós-graduação em Saúde da Criança e do Adolescente, Universidade Federal do Paraná, Brazil. Electronic address: laura.araujo80@gmail.com.'}, {'ForeName': 'Claudemir', 'Initials': 'C', 'LastName': 'Souza', 'Affiliation': 'Instituto Carlos Chagas - FIOCRUZ, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Nilson I T', 'Initials': 'NIT', 'LastName': 'Zanchin', 'Affiliation': 'Instituto Carlos Chagas - FIOCRUZ, Curitiba, Paraná, Brazil.'}, {'ForeName': 'Nelson A', 'Initials': 'NA', 'LastName': 'Rosário Filho', 'Affiliation': 'Programa de Pós-graduação em Saúde da Criança e do Adolescente, Universidade Federal do Paraná, Brazil.'}]",Allergologia et immunopathologia,['10.1016/j.aller.2019.12.003']
197,31924120,Effectiveness of Extracorporeal Shockwave Therapy in the Treatment of Chronic Insertional Achilles Tendinopathy.,"BACKGROUND
Extracorporeal shockwave therapy (ESWT) has been proposed as a conservative treatment for insertional Achilles tendinopathy from limited evidence without placebo controls. Our objective was to assess the effectiveness of ESWT compared with sham controls in chronic insertional Achilles tendinopathy.
METHODS
A double-blind, randomized sham-controlled trial was conducted between 2016 and 2018. The inclusion criteria were patients aged 18 to 70 years diagnosed with chronic insertional Achilles tendinopathy who failed standard conservative treatment. After computerized randomization, patients were allocated into either low-energy ESWT or sham control. Pain, function, and other complaints were assessed using visual analog scale (VAS) and VAS foot and ankle (VAS-FA) at preintervention and weeks 2, 3, 4, 6, 12, and 24. Intention-to-treat analysis and repeated measurement were performed using STATA 15.0.
RESULTS
Sixteen patients in ESWT and 15 patients in sham control groups had nonsignificant different baseline characteristics with preintervention VAS (6.0 ± 2.6 vs 5.2 ± 2.2) and VAS-FA (64.8 ± 16.6 vs 65.3 ± 12.7). There was no significant difference in VAS, VAS-FA, and its domains in the long term between the 2 groups. In addition, the ESWT group had significant improvement in VAS (2.9 ± 2.2) at weeks 4 to 12, and sham controls group had significantly improved VAS (2.3 ± 2.6) at weeks 12 to 24. Complications were found only after ESWT treatment.
CONCLUSION
There was no difference at 24 weeks with the use of low-energy ESWT for chronic insertional Achilles tendinopathy, especially in elderly patients. However, it may provide a short period of therapeutic effects as early as weeks 4 to 12.
LEVEL OF EVIDENCE
Level I, randomized controlled study.",2020,"There was no significant difference in VAS, VAS-FA, and its domains in the long term between the 2 groups.","['2016 and 2018', 'Chronic Insertional Achilles Tendinopathy', 'elderly patients', 'patients aged 18 to 70 years diagnosed with chronic insertional Achilles tendinopathy who failed standard conservative treatment']","['ESWT', 'Extracorporeal shockwave therapy (ESWT', 'Extracorporeal Shockwave Therapy', 'low-energy ESWT or sham control']","['VAS, VAS-FA, and its domains', 'VAS', 'visual analog scale (VAS) and VAS foot and ankle (VAS-FA', 'Pain, function, and other complaints', 'Complications']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3838864', 'cui_str': 'Insertional Achilles tendinopathy (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.168507,"There was no significant difference in VAS, VAS-FA, and its domains in the long term between the 2 groups.","[{'ForeName': 'Siwadol', 'Initials': 'S', 'LastName': 'Pinitkwamdee', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sukij', 'Initials': 'S', 'LastName': 'Laohajaroensombat', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Jakrapong', 'Initials': 'J', 'LastName': 'Orapin', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Patarawan', 'Initials': 'P', 'LastName': 'Woratanarat', 'Affiliation': 'Department of Orthopedic Surgery, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Foot & ankle international,['10.1177/1071100719898461']
198,32285238,"Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators.","Implantable cardioverter defibrillators (ICDs) save lives, but often induce significant psychological distress among patients. Positive psychological constructs are associated with improved outcomes among cardiac patients. In this NHLBI-funded randomized controlled trial, one aim was to evaluate the feasibility and acceptability of a positive psychology intervention (Quality of Life Therapy; QOLT, n = 11), compared to a Heart Healthy Education (HHE) control (n = 10), among ICD patients. A majority of participants across groups attended all 12 sessions (71%) and completed homework assignments (80%). Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20). A greater proportion of QOLT participants rated their sessions was ""very"" helpful compared to HHE participants (63% vs. 10%, p = 0.19). These initial data support the feasibility and acceptability of QOLT. A larger-scale trial using positive psychology interventions among ICD patients is indicated to determine potential mechanisms underlying the relationship between positive psychological constructs and cardiovascular health.",2020,"Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20).","['ICD patients', 'patients with implantable cardioverter defibrillators', ' n\u2009=\u200911), compared to a Heart Healthy Education (HHE) control (n\u2009=\u200910), among ICD patients']","['positive psychology intervention (Quality of Life Therapy; QOLT', 'Implantable cardioverter defibrillators (ICDs', 'positive psychology interventions']","['participant engagement and interventionist protocol adherence', 'positive emotions', 'feasibility and acceptability']","[{'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",1.0,0.071956,"Agreement on participant engagement and interventionist protocol adherence were high, with no differences between groups (ps > 0.20).","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA.'}, {'ForeName': 'Lillian M', 'Initials': 'LM', 'LastName': 'Christon', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Rodrigue', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Fava', 'Affiliation': 'Centers for Behavioral and Preventive Medicine, The Miriam Hospital, Providence, RI, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Frisch', 'Affiliation': 'Baylor University, Waco, TX, USA.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Serber', 'Affiliation': 'Division of Bio-Behavioral Medicine, Medical University of South Carolina, 67 President Street, MSC 861, Charleston, SC, 29425, USA. serbere@musc.edu.'}]",Journal of behavioral medicine,['10.1007/s10865-020-00153-2']
199,32286669,"Physio-Feedback and Exercise Program (PEER) Improves Balance, Muscle Strength, and Fall Risk in Older Adults.","A one-group pre/posttest study was conducted to examine the feasibility and effect size of an 8-week physio-feedback and exercise program (PEER) on improving balance, muscle strength, and fall risk. Nineteen participants (mean age = 76 years) received the intervention, which included visual physio-feedback by the BTrackS™ Assess Balance System, cognitive reframing, and a combined group- and home-based exercise program by a trained peer coach. Pre- and post-measurement outcomes were evaluated for balance, handgrip strength, and fall risk. Feasibility was assessed by dropout rate, safety, and adherence to exercise. Significant improvements were noted in dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk. Participants' attendance was 87.5%, with no fall incidence. The physio-feedback, cognitive reframing, and peer coaching facilitate older adults to align their perceived fall risk with physiological fall risk and motivate them to stay active. PEER intervention is feasible; safe; improves balance, muscle strength, and fall risk; and may enhance activity engagement.
TARGETS
Community-dwelling older adults.
INTERVENTION DESCRIPTION
Provide visual physio-feedback and cognitive reframing based on the fall risk appraisal matrix and participate in combined group- and home-based exercises by a trained peer coach.
MECHANISM OF ACTION
Align perceived and physiological fall risk, peer coaching to exercise.
OUTCOMES
Balance, handgrip strength, fall risk, and activity engagement. [Research in Gerontological Nursing, 13(6), 289-296.].",2020,"Significant improvements were noted in dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk.","['Community-dwelling older adults', 'Nineteen participants (mean age = 76 years) received the', 'Older Adults']","['intervention, which included visual physio-feedback by the BTrackS™ Assess Balance System, cognitive reframing, and a combined group- and home-based exercise program by a trained peer coach', '8-week physio-feedback and exercise program (PEER', 'PEER intervention', 'Physio-Feedback and Exercise Program (PEER']","['balance, handgrip strength, and fall risk', 'balance, muscle strength, and fall risk', 'Balance, handgrip strength, fall risk, and activity engagement', 'Improves Balance, Muscle Strength, and Fall Risk', 'dropout rate, safety, and adherence to exercise', 'dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0138067,"Significant improvements were noted in dynamic balance (Sit-to-Stand, Timed Up & Go tests), handgrip strength, and fall risk.","[{'ForeName': 'Ladda', 'Initials': 'L', 'LastName': 'Thiamwong', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': ''}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Sole', 'Affiliation': ''}, {'ForeName': 'Boon Peng', 'Initials': 'BP', 'LastName': 'Ng', 'Affiliation': ''}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Talbert', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20200324-01']
200,31289334,The effects of exercise session timing on weight loss and components of energy balance: midwest exercise trial 2.,"BACKGROUND/OBJECTIVES
Circadian physiology has been linked to body weight regulation and obesity. To date, few studies have assessed the association between exercise timing and weight related outcomes. The aim of this secondary analysis was to explore the impact of exercise timing (i.e., 24 h clock time of exercise session) on weight loss and components of energy balance.
SUBJECTS/METHODS
Overweight/obese (BMI 25.0-39.9 kg/m 2 ), physically inactive, young adults (~51% female) completed a 10-month supervised exercise program (400 or 600 kcal/session for 5 days/week) or served as non-exercise controls (CON). Participants were categorized based on the time of day in which they completed exercise sessions (Early-Ex: >50% of sessions completed between 7:00 and 11:59 am; (n = 21), Late-Ex: >50% of sessions completed between 3:00 and 7:00 pm; (n = 25), Sporadic-Ex: <50% of sessions completed in any time category; (n = 24), and CON; (n = 18)). Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer) were assessed at baseline, 3.5, 7, and 10 months. Total daily energy expenditure (TDEE; doubly labeled water), was assessed at baseline and 10 months.
RESULTS
At month 10, weight loss was significantly greater in both Early-EX (-7.2 ± 1.2%; p < 0.001) and Sporadic-EX (- 5.5 ± 1.2%; p = 0.01) vs CON (+0.5 ± 1.0%), and Early-EX vs Late-EX (-2.1 ± 1.0%; p < 0.001). There were no between group differences for change in TDEE, EI, and non-exercise energy expenditure (P > 0.05). A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
CONCLUSIONS
Despite minimal differences in components of energy balance, Early-EX lost significantly more weight compared with Late-Ex. Although the mechanisms are unclear, the timing of exercise may be important for body weight regulation.",2020,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","['Overweight/obese (BMI 25.0-39.9\u2009kg/m 2 ), physically inactive, young adults (~51% female']","['exercise session', 'supervised exercise program (400 or 600\u2009kcal/session for 5 days/week) or served as non-exercise controls (CON', 'CON']","['Total daily energy expenditure (TDEE; doubly labeled water', 'time interaction', 'weight loss', 'Body weight, energy intake (EI; digital photography), and non-exercise physical activity (NEPA; accelerometer', 'change in TDEE, EI, and non-exercise energy expenditure', 'weight loss and components of energy balance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0725595,"A significant group × time interaction (p = 0.02) was observed for NEPA (counts/min), however, after adjusting for multiple comparisons, group effects were no longer significant.
","[{'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA. erik.willis@unc.edu.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Creasy', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Jeffery J', 'Initials': 'JJ', 'LastName': 'Honas', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Anschutz Medical Campus, University of Colorado Aurora, Aurora, CO, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, Kansas City, KS, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0409-x']
201,31292531,One-year postpartum anthropometric outcomes in mothers and children in the LIFE-Moms lifestyle intervention clinical trials.,"BACKGROUND/OBJECTIVES
Excess gestational weight gain (GWG) is a risk factor for maternal postpartum weight retention and excessive neonatal adiposity, especially in women with overweight or obesity. Whether lifestyle interventions to reduce excess GWG also reduce 12-month maternal postpartum weight retention and infant weight-for-length z score is unknown. Randomized controlled trials from the LIFE-Moms consortium investigated lifestyle interventions that began in pregnancy and tested whether there was benefit through 12 months on maternal postpartum weight retention (i.e., the difference in weight from early pregnancy to 12 months) and infant-weight-for-length z scores.
SUBJECTS/METHODS
In LIFE-Moms, women (N = 1150; 14.1 weeks gestation at enrollment) with overweight or obesity were randomized within each of seven trials to lifestyle intervention or standard care. Individual participant data were combined and analyzed using generalized linear mixed models with trial entered as a random effect. The 12-month assessment was completed by 83% (959/1150) of women and 84% (961/1150) of infants.
RESULTS
Compared with standard care, lifestyle intervention reduced postpartum weight retention (2.2 ± 7.0 vs. 0.7 ± 6.2 kg, respectively; difference of -1.6 kg (95% CI -2.5, -0.7; p = 0.0003); the intervention effect was mediated by reduction in excess GWG, which explained 22% of the effect on postpartum weight retention. Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care. There was no statistically significant treatment group effect on infant anthropometric outcomes at 12 months.
CONCLUSIONS
Compared with standard care, lifestyle interventions initiated in pregnancy and focused on healthy eating, increased physical activity, and other behavioral strategies resulted in significantly less weight retention but similar infant anthropometric outcomes at 12 months postpartum in a large, diverse US population of women with overweight and obesity.",2020,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","['women (N\u2009=\u20091150; 14.1 weeks gestation at enrollment) with overweight or obesity', 'mothers and children in the LIFE-Moms lifestyle intervention clinical trials', 'women with overweight or obesity']","['lifestyle intervention or standard care', 'LIFE-Moms consortium investigated lifestyle interventions']","['maternal postpartum weight retention and infant weight-for-length z score', 'infant anthropometric outcomes', 'weight retention', 'infant-weight-for-length z scores', 'postpartum weight retention', 'maternal postpartum weight retention']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4704811', 'cui_str': 'Postpartum Weight Retention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",1150.0,0.182381,"Lifestyle intervention also significantly increased the odds (OR = 1.68 (95% CI, 1.26, 2.24)) and percentage of mothers (48.2% vs. 36.2%) at or below baseline weight at 12 months postpartum (yes/no) compared with standard care.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Phelan', 'Affiliation': 'Department of Kinesiology & Public Health, California Polytechnic State University, San Luis Obispo, CA, USA. sphelan@calpoly.edu.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Clifton', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Haire-Joshu', 'Affiliation': 'Center for Diabetes Translation Research, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Van Horn', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Kaumudi', 'Initials': 'K', 'LastName': 'Joshipura', 'Affiliation': 'Center for Clinical Research and Health Promotion, School of Dental Medicine, Medical Sciences Campus, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Couch', 'Affiliation': 'Phoenix Indian Medical Center, Indian Health Service, Phoenix, AZ, USA.'}, {'ForeName': 'S Sonia', 'Initials': 'SS', 'LastName': 'Arteaga', 'Affiliation': 'The National Heart, Lung, and Blood Institute, Bethesda, MD, USA.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kimberly L', 'Initials': 'KL', 'LastName': 'Drews', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Franks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan Public Health School, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Dympna', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Josefson', 'Affiliation': 'Department of Pediatrics, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University, Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': 'The Biostatistics Center, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital and the Department of Psychiatry and Human Behavior, Warren Alpert Medical School at Brown University, Providence, RI, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'The National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'New York Obesity Research Center, Dept. of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0410-4']
202,31347178,The effect of assertiveness training in schizophrenic patients on functional remission and assertiveness level.,"PURPOSE
This research is conducted to evaluate the effect of assertiveness training in schizophrenic patients on functional remission and assertiveness level.
DESIGN AND METHODS
The research is designed as a randomized controlled trial with a pretest and posttest control group and repeated measures. Assertiveness training was carried out for a total of 8 weeks with the experimental group.
FINDINGS
Assertiveness training in schizophrenic patients was found to be effective in increasing the functional remission and assertiveness levels of patients.
PRACTICE IMPLICATIONS
Assertiveness training in schizophrenia should be implemented by psychiatric nurses within the scope of rehabilitation services.",2020,"FINDINGS
Assertiveness training in schizophrenic patients was found to be effective in increasing the functional remission and assertiveness levels of patients.
","['schizophrenic patients', 'schizophrenic patients on functional remission and assertiveness level']",['assertiveness training'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0004077', 'cui_str': 'Assertivenesses'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0150139', 'cui_str': 'Assertiveness training (procedure)'}]",[],,0.016672,"FINDINGS
Assertiveness training in schizophrenic patients was found to be effective in increasing the functional remission and assertiveness levels of patients.
","[{'ForeName': 'Gonca', 'Initials': 'G', 'LastName': 'Ustun', 'Affiliation': 'Department of Nursing, Amasya University Faculty of Health Sciences, Amasya, Turkey.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Kucuk', 'Affiliation': 'Department of Mental Health and Psychiatric Nursing, Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing, Istanbul, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12427']
203,32245712,Radiotherapy without tattoos: Could this work?,"INTRODUCTION
An evaluation to compare the traditional tattoo based set up procedure with a surface guided method to assess the possibility of eliminating permanent tattoos in breast cancer patents who are undergoing radiotherapy to the breast/chest wall.
METHODS
Forty-three patients that were having radiotherapy to the breast or chest wall were included in this evaluation. The patients were divided into two groups and further divided into 2 sub-groups. The first group received standard dark ink tattoos and were positioned by aligning these tattoos with lasers. The second group had no tattoo's and were positioned using the Surface-Guided technology (SGRT). Within each group the patients were split into 2 sub-group; right and left sided treatment areas. The right side were treated using a Free-Breathing (FB) technique and the left sided were treated using a Deep-Inspiration Breath-Hold (DIBH) technique.
RESULTS
For the patients having right sided breast radiotherapy, the mean shift using the standard tattoos and laser set up was 0.52 cm, compared with using the SGRT method where the mean shift was 0.47 cm. (p-value 0.04) For patients having left sided breast radiotherapy with DIBH the mean shift using the standard tattoo's and laser set up was 0.76 cm, compared with a mean shift of 0.45 cm using SGRT alone (p-value < 0.001).
CONCLUSION
The elimination of tattoos together with SGRT offers a comparable set-up for right sided breast treatments against the traditional tattoo method. A significant set-up improvement was observed for the left sided breast DIBH treatments.
IMPLICATIONS FOR PRACTICE
To set up patients having breast Radiotherapy, with no tattoo's.",2020,The second group had no tattoo's and were positioned using the Surface-Guided technology (SGRT).,"['Forty-three patients that were having radiotherapy to the breast or chest wall were included in this evaluation', 'breast cancer patents who are undergoing radiotherapy to the breast/chest wall']","['Radiotherapy without tattoos', 'Free-Breathing (FB) technique and the left sided were treated using a Deep-Inspiration Breath-Hold (DIBH) technique', 'standard dark ink tattoos and were positioned by aligning these tattoos with lasers']",[],"[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030650', 'cui_str': 'Patents'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1366940', 'cui_str': 'Tattoo of skin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0021510', 'cui_str': 'Ink'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C2369992', 'cui_str': 'Align'}, {'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]",[],43.0,0.0117039,The second group had no tattoo's and were positioned using the Surface-Guided technology (SGRT).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rigley', 'Affiliation': 'GenesisCare Nottingham, The Park Centre of Oncology, Sherwood Lodge Drive, Nottingham, NG5 8RX, UK. Electronic address: Joanne.Rigley@genesiscare.co.uk.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Robertson', 'Affiliation': 'GenesisCare Guildford, 46 Harvey Road, Guildford, GU1 3XL, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Scattergood', 'Affiliation': 'GenesisCare Nottingham, The Park centre of oncology, Sherwood Lodge Drive, Nottingham, NG5 8RX, UK.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2020.02.008']
204,31582408,Metabolite Profiles of Incident Diabetes and Heterogeneity of Treatment Effect in the Diabetes Prevention Program.,"Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development. We profiled 331 metabolites in 2,015 baseline plasma samples from the Diabetes Prevention Program (DPP). Cox models were used to determine associations between metabolites and incident T2D, as well as whether associations differed by treatment group (i.e., lifestyle [ILS], metformin [MET], or placebo [PLA]), over an average of 3.2 years of follow-up. We found 69 metabolites associated with incident T2D regardless of treatment randomization. In particular, cytosine was novel and associated with the lowest risk. In an exploratory analysis, 35 baseline metabolite associations with incident T2D differed across the treatment groups. Stratification by baseline levels of several of these metabolites, including specific phospholipids and AMP, modified the effect that ILS or MET had on diabetes development. Our findings highlight novel markers of diabetes risk and preventative treatment effect in individuals who are clinically at high risk and motivate further studies to validate these interactions.",2019,Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development.,"['2,015 baseline plasma samples from the Diabetes Prevention Program (DPP', 'individuals with similar clinical risk']","['cytosine', 'metformin (MET), or placebo (PLA']",[],"[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0058353', 'cui_str': 'DPPS'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0010843', 'cui_str': 'Cytosine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],331.0,0.0206204,Novel biomarkers of type 2 diabetes (T2D) and response to preventative treatment in individuals with similar clinical risk may highlight metabolic pathways that are important in disease development.,"[{'ForeName': 'Zsu-Zsu', 'Initials': 'ZZ', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Jinxi', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Biostatistics Center and Milken Institute School of Public Health, George Washington University, Rockville, MD.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Morningstar', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Brandy M', 'Initials': 'BM', 'LastName': 'Heckman-Stoddard', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Christine G', 'Initials': 'CG', 'LastName': 'Lee', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Dagogo-Jack', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Jane F', 'Initials': 'JF', 'LastName': 'Ferguson', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Hamman', 'Affiliation': 'Department of Epidemiology, Colorado School of Public Health, University of Colorado Denver, Aurora, CO.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Perreault', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Florez', 'Affiliation': 'Diabetes Unit and Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Clary', 'Initials': 'C', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of MIT and Harvard, Cambridge, MA.'}, {'ForeName': 'Marinella', 'Initials': 'M', 'LastName': 'Temprosa', 'Affiliation': 'Department of Epidemiology and Biostatistics, Biostatistics Center and Milken Institute School of Public Health, George Washington University, Rockville, MD.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gerszten', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db19-0236']
205,30753650,Strengthening sleep-autonomic interaction via acoustic enhancement of slow oscillations.,"Slow-wave sleep (SWS) is important for overall health since it affects many physiological processes including cardio-metabolic function. Sleep and autonomic nervous system (ANS) activity are closely coupled at anatomical and physiological levels. Sleep-related changes in autonomic function are likely the main pathway through which SWS affects many systems within the body. There are characteristic changes in ANS activity across sleep stages. Notably, in non-rapid eye-movement sleep, the progression into SWS is characterized by increased parasympathetic activity, an important measure of cardiovascular health. Experimental manipulations that enhance slow-wave activity (SWA, 0.5-4 Hz) can improve sleep-mediated memory and immune function. However, effects of SWA enhancement on autonomic regulation have not been investigated. Here, we employed an adaptive algorithm to deliver 50 ms sounds phase-locked to slow-waves, with regular pauses in stimulation (~5 s ON/~5 s OFF), in healthy young adults. We sought to determine whether acoustic enhancement of SWA altered parasympathetic activity during SWS assessed with heart rate variability (HRV), and evening-to-morning changes in HRV, plasma cortisol, and blood pressure. Stimulation, compared with a sham condition, increased SWA during ON versus OFF intervals. This ON/OFF SWA enhancement was associated with a reduction in evening-to-morning change of cortisol levels and indices of sympathetic activity. Furthermore, the enhancement of SWA in ON intervals during sleep cycles 2-3 was accompanied by an increase in parasympathetic activity (high-frequency, HRV). Together these findings suggest that acoustic enhancement of SWA has a positive effect on autonomic function in sleep. Approaches to strengthen brain-heart interaction during sleep could have important implications for cardiovascular health.",2019,This ON/OFF SWA enhancement was associated with a reduction in evening-to-morning change of cortisol levels and indices of sympathetic activity.,['healthy young adults'],"['adaptive algorithm to deliver 50 ms sounds phase-locked to slow-waves, with regular pauses in stimulation ', 'Slow-wave sleep (SWS']","['sleep-mediated memory and immune function', 'heart rate variability (HRV), and evening-to-morning changes in HRV, plasma cortisol, and blood pressure', 'Sleep and autonomic nervous system (ANS) activity', 'autonomic function', 'SWA', 'parasympathetic activity']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0234451', 'cui_str': 'Non-rapid eye movement sleep'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}]",,0.0478366,This ON/OFF SWA enhancement was associated with a reduction in evening-to-morning change of cortisol levels and indices of sympathetic activity.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Grimaldi', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Nelly A', 'Initials': 'NA', 'LastName': 'Papalambros', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Reid', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Sabra M', 'Initials': 'SM', 'LastName': 'Abbott', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Roneil G', 'Initials': 'RG', 'LastName': 'Malkani', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Gendy', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Iwanaszko', 'Affiliation': 'Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Rosemary I', 'Initials': 'RI', 'LastName': 'Braun', 'Affiliation': 'Biostatistics Division, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sanchez', 'Affiliation': 'SRI International, Menlo Park, CA.'}, {'ForeName': 'Ken A', 'Initials': 'KA', 'LastName': 'Paller', 'Affiliation': 'Department of Psychology, Northwestern University, Evanston, IL.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL.'}]",Sleep,['10.1093/sleep/zsz036']
206,31377190,Comparison of Rest to Aerobic Exercise and Placebo-like Treatment of Acute Sport-Related Concussion in Male and Female Adolescents.,"OBJECTIVE
To compare a sample of adolescents with sport-related concussion (SRC) who were prescribed rest with 2 arms of a randomized controlled trial comparing aerobic exercise with placebo-like stretching. We also compared sex differences across the 3 approaches to treatment.
DESIGN
Quasi-experimental trial.
SETTING
University concussion management clinics.
PARTICIPANTS
Adolescent athletes (aged 13-18 years) presenting within 10 days of SRC (mean, 5 days after injury) received a recommendation for rest (rest group [RG], n=48, 15.4±1y, 25% female). Their outcomes were compared with matched samples of adolescents assigned to aerobic exercise (exercise group [EG], n=52, 15.3±2y, 46% female) or placebo-like stretching (placebo group [PG], n=51, 15.4±2y, 47% female) (N=151).
MAIN OUTCOME MEASURES
The primary outcome was median days from injury to recovery. The secondary outcome was proportion classified as normal recovery (<30d) or delayed recovery (≥30d).
RESULTS
The RG recovered in 16 days (interquartile range, 9.25-23.25d), which was significantly delayed (P=.020) compared with EG (13d; interquartile range, 10-18.5d). The PG recovered in 17 days (interquartile range, 13-23d). Four percent of the EG, 14% of the PG, and 13% of the RG had delayed recovery (P=.190). There was no difference in recovery time or delayed recovery between male participants and female participants across groups. Female participants prescribed rest experienced an increase in symptoms vs the other groups (P=.013).
CONCLUSION
Relative rest and a placebo-like stretching program were very similar in days to recovery and symptom improvement pattern after SRC. Both conditions were less effective than subsymptom threshold aerobic exercise. Female adolescents appear to be susceptible to symptom increase when prescribed rest.",2019,"Female participants prescribed rest experienced an increase in symptoms vs the other groups (P=.013).
","['Female adolescents', 'adolescents with sport-related concussion (SRC', 'Adolescent athletes (aged 13-18 years) presenting within 10 days of SRC (mean, 5 days after injury) received a recommendation for rest (rest group [RG], n=48, 15.4±1y, 25% female', 'Acute Sport-Related Concussion in Male and Female Adolescents', 'University concussion management clinics', 'group [PG], n=51, 15.4±2y, 47% female) (N=151', 'male participants and female participants across groups']","['aerobic exercise with placebo-like stretching', 'aerobic exercise (exercise group [EG', 'placebo-like stretching (placebo', 'placebo-like stretching program', 'Rest to Aerobic Exercise and Placebo-like Treatment']","['proportion classified as normal recovery (<30d) or delayed recovery (≥30d', 'median days from injury to recovery', 'recovery time or delayed recovery', 'delayed recovery', 'RG']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0006107', 'cui_str': 'Cerebral Concussion'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.694695,"Female participants prescribed rest experienced an increase in symptoms vs the other groups (P=.013).
","[{'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Willer', 'Affiliation': 'Department of Psychiatry, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States. Electronic address: bswiller@buffalo.edu.'}, {'ForeName': 'Mohammad N', 'Initials': 'MN', 'LastName': 'Haider', 'Affiliation': 'UBMD Department of Orthopaedics and Sports Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States; PhD Program in Biomedical Science, Neuroscience, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Bezherano', 'Affiliation': 'Department of Nutrition and Exercise Science, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Wilber', 'Affiliation': 'UBMD Department of Orthopaedics and Sports Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Mannix', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts, United States.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kozlowski', 'Affiliation': 'Department of Nutrition and Exercise Science, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Leddy', 'Affiliation': 'UBMD Department of Orthopaedics and Sports Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, New York, United States.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.07.003']
207,32281269,Comparison of Physical Therapy and Physician Pathways for Employees with Recent Onset Musculoskeletal Pain: A Randomized Controlled Trial.,"BACKGROUND
Life expectancy of the U.S. population will continue to rise, increasing the workforce demands in the treatment of musculoskeletal pathologies. With a declining primary care physician workforce, physical therapists (PT) may be in a unique situation to help absorb this demand.
OBJECTIVE
Our primary objective was to compare physical function between two primary care groups, a ""physical therapy-led pathway"" versus ""physician-led pathway"" in the management of recent-onset musculoskeletal pain at 1-month follow-up. Our secondary objectives were to compare other patient-important outcomes between the groups at 1 month and health utilization at 1 month and 1 year.
METHODS
A pragmatic randomized controlled trial with a 1-year follow-up was conducted, enrolling 150 university employees with recent onset musculoskeletal pain. Participants were randomized at first contact to either a PT-led pathway or physician-led pathway. The primary outcome was change in Patient-Reported Outcomes Measurement Information System (PROMIS) ShortForm v1-Physical Function 10a at 1 month; groups were compared with repeated measurement of analysis of variance and chi-square for both primary and secondary outcomes, except for satisfaction score at 1 month, which was cross-sectionally compared by independent two-sample t-test. At 1 year, healthcare utilization was assessed through medical record extraction, and healthcare utilization was converted to total episodic standard cost. Utilization was compared between groups using chi-square and Wilcoxon rank-sum tests.
RESULTS
Both groups demonstrated improvement at 1-month follow-up but showed no significant between-group difference in mean PROMIS scores at 1 month (PT-led pathway vs physician-led pathway, 2.04, [95% CI -0.28 to 4.36]; P = .082). At 1 year, there was no difference in healthcare utilization or cost between groups. No harm or misdiagnosis was found, filed, or reported by participants at 1 year.
CONCLUSION
This study shows equivalence in outcomes for two low-cost musculoskeletal care pathways with no risk of harm. These results reinforce other findings in the literature that support PTs as safe and effective initial providers for individuals with musculoskeletal disorders.",2020,"Both groups demonstrated improvement at 1-mo follow-up but showed no significant between-group difference in mean PROMIS scores at 1-mo (PT-led pathway vs physician-led pathway, 2.04, [95CI -0.28 to 4.36]; P = .0819).","['150 university employees with recent onset musculoskeletal pain', 'individuals with musculoskeletal disorders', 'For Employees With Recent Onset Musculoskeletal Pain']","['PT-led pathway or physician-led pathway', 'Physical Therapy And Physician Pathways', 'physical therapy-led pathway"" vs ""physician-led pathway']","['satisfaction score', 'No harm or misdiagnosis', 'change in PROMIS ShortForm v1-Physical Function', 'healthcare utilization or cost', 'mean PROMIS scores']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",150.0,0.0950043,"Both groups demonstrated improvement at 1-mo follow-up but showed no significant between-group difference in mean PROMIS scores at 1-mo (PT-led pathway vs physician-led pathway, 2.04, [95CI -0.28 to 4.36]; P = .0819).","[{'ForeName': 'Heidi A', 'Initials': 'HA', 'LastName': 'Ojha', 'Affiliation': 'Physical Therapy Program, College of Public Health, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Fritz', 'Affiliation': 'College of Health, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Alyson L', 'Initials': 'AL', 'LastName': 'Malitsky', 'Affiliation': 'Good Shepherd Penn Partners, Bala Cynwyd, PA, USA.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Epidemiology and Biostatistics, Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Weiner', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, NY, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Brandi', 'Affiliation': 'Moss Rehabilitation Hospital, Physical Therapy, Philadelphia, PA, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Rhon', 'Affiliation': 'Doctoral Program in Physical Therapy, JBSA Fort Sam Houston, Baylor University, San Antonio, TX, USA.'}, {'ForeName': 'Ben H P', 'Initials': 'BHP', 'LastName': 'Mobo', 'Affiliation': 'Temple University, Temple Employee Health Service, Philadelphia, PA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Fleming', 'Affiliation': 'Odyssey Physical Therapy, Philadelphia, PA, USA.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Beidleman', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA, USA.'}, {'ForeName': 'W Geoffrey', 'Initials': 'WG', 'LastName': 'Wright', 'Affiliation': 'Physical Therapy Program, College of Public Health, Temple University, Philadelphia, PA, USA.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12382']
208,31677583,Ethnicity and health outcomes among people with epilepsy participating in an epilepsy self-management RCT.,"People with epilepsy (PWE) may experience negative health events (NHEs) such as seizures, emergency room visits, and hospitalizations, with ethnic and racial minorities disproportionately affected. Epilepsy self-management may reduce NHEs; however, few reports examine self-management outcomes in racial minorities. Using data from a longitudinal 6-month randomized controlled trial (RCT) of 120 PWE, this analysis compared African-American and Whites at baseline, 10 weeks and 24 weeks after receiving the ""Self-management for people with epilepsy (SMART) and a history of NHEs"" self-management program. The primary RCT outcome was number of NHEs. At baseline, compared to Whites, African-Americans had less education (p = 0.02) and greater depressive severity (p = 0.04). Both African-American and Whites generally improved with SMART, and there were no racial differences in NHE counts or other outcomes' responses. Given known racial disparities in epilepsy care, it may be particularly important to reach out to minority PWE with self-management programs.",2019,"Both African-American and Whites generally improved with SMART, and there were no racial differences in NHE counts or other outcomes' responses.","['African-American and Whites at baseline, 10\u202fweeks and 24\u202fweeks after receiving the ""Self-management for people with epilepsy (SMART) and a history of NHEs"" self-management program', 'People with epilepsy (PWE', 'people with epilepsy participating in an epilepsy self-management RCT']",[],"['number of NHEs', 'Ethnicity and health outcomes', 'depressive severity']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0414492,"Both African-American and Whites generally improved with SMART, and there were no racial differences in NHE counts or other outcomes' responses.","[{'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Aebi', 'Affiliation': 'Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Lu', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Burant', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, Cleveland, Ohio, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': 'Department of Psychiatry and of Neurology, Neurological & Behavioral Outcomes Center, Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA. Electronic address: Martha.Sajatovic@uhhospitals.org.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106469']
209,32227755,Initial Invasive or Conservative Strategy for Stable Coronary Disease.,"BACKGROUND
Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain.
METHODS
We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction.
RESULTS
Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32).
CONCLUSIONS
Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).",2020,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","['patients with stable coronary disease and moderate or severe ischemia', 'Stable Coronary Disease', '5179 patients with moderate or severe ischemia to an']","['initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed', 'invasive intervention plus medical therapy']","['death from cardiovascular causes or myocardial infarction', 'risk of ischemic cardiovascular events or death', 'definition of myocardial infarction', 'procedural myocardial infarctions of uncertain clinical importance', 'composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest', 'cumulative event rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2587207', 'cui_str': 'Resuscitate'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",5179.0,0.217237,"At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Boden', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Roxy', 'Initials': 'R', 'LastName': 'Senior', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'López-Sendón', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Newman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Sidhu', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Ruzyllo', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Gosselin', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Berman', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Picard', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ziad A', 'Initials': 'ZA', 'LastName': 'Ali', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Spertus', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Mangalath N', 'Initials': 'MN', 'LastName': 'Krishnan', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Nagaraja', 'Initials': 'N', 'LastName': 'Moorthy', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Whady A', 'Initials': 'WA', 'LastName': 'Hueb', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Kreton', 'Initials': 'K', 'LastName': 'Mavromatis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bockeria', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Peteiro', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Miller', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Szwed', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Kohsaka', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Mavromichalis', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Kirby', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Neal O', 'Initials': 'NO', 'LastName': 'Jeffries', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Broderick', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'T Bruce', 'Initials': 'TB', 'LastName': 'Ferguson', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Williams', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From the Department of Medicine, Stanford University School of Medicine, Stanford (D.J.M., R.A.H.), and Cedars-Sinai Medical Center, Los Angeles (D.S.B.) - both in California; New York University Grossman School of Medicine (J.S.H., H.R.R., S. Bangalore, J.S.B., J.D.N., S.M.), Weill Cornell Medicine/New York-Presbyterian Hospital (L.J.S.), Cleerly (J.K.M.), the Cardiovascular Research Foundation (Z.A.A., G.W.S.), Columbia University Irving Medical Center/New York-Presbyterian Hospital (Z.A.A.), and Icahn School of Medicine at Mount Sinai (G.W.S.), New York, Albany Medical College and Albany Medical Center, Albany (M.S.S.), and St. Francis Hospital, Roslyn (Z.A.A.) - all in New York; Duke Clinical Research Institute, Durham (S.M.O., K.P.A., R.D.L., D.B.M., F.W.R., S. Broderick), and Brody School of Medicine, East Carolina University, Greenville (T.B.F.) - both in North Carolina; Veterans Affairs (VA) New England Healthcare System and Boston University School of Medicine (W.E.B.), Massachusetts General Hospital and Harvard Medical School (M.H.P.), and Brigham and Women's Hospital (R.Y.K., D.O.W.) - all in Boston; Saint Louis University School of Medicine, St. Louis (B.R.C.), and the Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City School of Medicine, Kansas City (J.A.S.); Northwick Park Hospital (R.S., A.E.) and Imperial College London and Royal Brompton Hospital (R.S.) - all in London; Hospital Universitario La Paz, Instituto de Investigación de La Paz, Centro de Investigación Biomédica en Red Cardiovascular, Madrid (J.L.-S.), and Complejo Hospitalario Universitario A Coruna, Centro de Investigación Biomédica en Red Cardiovascular, A Coruna (J.P.) - all in Spain; Canadian Heart Research Centre and St. Michael's Hospital, University of Toronto, Toronto (S.G.G.), Montreal Heart Institute Research Center, Montreal (G.G.), and the University of British Columbia, Vancouver (G.B.J.M.) - all in Canada; the Department of Coronary and Structural Heart Diseases (M.D.), National Institute of Cardiology (W.R., M.D., H.S.), Warsaw, Poland; Associazione Nazionale Medici Cardiologi Ospedalieri, Florence, Italy (A.P.M.); Auckland Hospital Green Lane Cardiovascular Services, Auckland, New Zealand (H.D.W.); All India Institute of Medical Sciences, New Delhi (B.B.), Government Medical College Kozhikode, Kerala (M.N.K.), and Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore (N.M.) - all in India; Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Faculdade de Medicina, Universidade de São Paulo, São Paulo (W.A.H.); Emory University School of Medicine-Atlanta VA Medical Center, Decatur, Georgia (K.M.); the National Research Center for Cardiovascular Surgery, Moscow (O.B.); Mayo Clinic, Rochester, MN (T.D.M.); Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.); Semmelweis University, Budapest, Hungary (M.K.); Flinders University, Flinders Medical Centre, Adelaide, SA, Australia (J.B.S.); Université de Paris, Assistance Publique-Hôpitaux de Paris, and INSERM Unité 1148, Paris (P.G.S.); the Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (C.H.); Keio University School of Medicine, Shinjuku, Tokyo (S.K.); the National Institutes of Health, Bethesda, MD (R.K., N.O.J., Y.R.); and Vanderbilt University School of Medicine, Nashville (F.E.H.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915922']
210,32280072,Effects of Fresnel prism glasses on balance and gait in stroke patients with hemiplegia: A randomized controlled trial pilot study.,"BACKGROUND
Fresnel prism shifts the field of view and converts object position in space, but its effect on stroke patients without unilateral neglect has not been examined.
OBJECTIVE
We aimed to investigate the effect of Fresnel prism glasses on balance and gait in stroke patients with hemiplegia.
METHODS
This study included 17 stroke patients with hemiplegia without unilateral neglect. Balance and gait training were applied in the control group (n= 9), and Fresnel prism glasses were applied with balance and gait training in the experimental group (n= 8). In all groups, interventions were done for 30 min/day for 5 times/week for 4 weeks. Motor-free visual perception test for visual perception (MVPT), Berg Balance Scale (BBS), and functional reach test (FRT) for dynamic balance ability, and gait were performed. Measurements were done before and after interventions.
RESULTS
MVPT showed no significant difference between the groups (p> 0.05). A significant increase in BBS and FRT results was found before and after interventions in the experimental group (p< 0.05). Gait variables showed significant difference in the experimental group (p< 0.05).
CONCLUSION
Fresnel prism glasses may effectively improve dynamic balance and gait functions by shifting body weight to the affected side of stroke patients with hemiplegia without vision loss.",2020,A significant increase in BBS and FRT results was found before and after interventions in the experimental group (p< 0.05).,"['17 stroke patients with hemiplegia without unilateral neglect', 'stroke patients without unilateral neglect', 'stroke patients with hemiplegia', 'stroke patients with hemiplegia without vision loss']","['Balance and gait training', 'Fresnel prism glasses', 'Fresnel prism glasses were applied with balance and gait training']","['balance and gait', 'BBS and FRT results', 'dynamic balance and gait functions', 'Motor-free visual perception test for visual perception (MVPT), Berg Balance Scale (BBS), and functional reaching test (FRT) for dynamic balance ability, and gait']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0150088', 'cui_str': 'Hemi-neglect'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1998271', 'cui_str': 'Functional reach test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1300593', 'cui_str': 'Motor free visual perception test'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}]",17.0,0.0299997,A significant increase in BBS and FRT results was found before and after interventions in the experimental group (p< 0.05).,"[{'ForeName': 'Sun-Young', 'Initials': 'SY', 'LastName': 'Ha', 'Affiliation': 'Department of Physical Therapy, Graduate School, Kyungnam University, Korea.'}, {'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Sung', 'Affiliation': 'Department of Physical Therapy, Graduate School, Kyungnam University, Korea.'}]",Technology and health care : official journal of the European Society for Engineering and Medicine,['10.3233/THC-191973']
211,32249788,Alleviation of migraine symptoms by application of repetitive peripheral magnetic stimulation to myofascial trigger points of neck and shoulder muscles - A randomized trial.,"Migraine is a burdensome disease with an especially high prevalence in women between the age of 15 and 49 years. Non-pharmacological, non-invasive therapeutic methods to control symptoms are increasingly in demand to complement a multimodal intervention approach in migraine. Thirty-seven subjects (age: 25.0 ± 4.1 years; 36 females) diagnosed with high-frequency episodic migraine who presented at least one active myofascial trigger point (mTrP) in the trapezius muscles and at least one latent mTrP in the deltoid muscles bilaterally prospectively underwent six sessions of repetitive peripheral magnetic stimulation (rPMS) over two weeks. Patients were randomly assigned to receive rPMS applied to the mTrPs of the trapezius (n = 19) or deltoid muscles (n = 18). Whereas the trapezius muscle is supposed to be part of the trigemino-cervical complex (TCC) and, thus, involved in the pathophysiology of migraine, the deltoid muscle was not expected to interfere with the TCC and was therefore chosen as a control stimulation site. The headache calendar of the German Migraine and Headache Society (DMKG) as well as the Migraine Disability Assessment (MIDAS) questionnaire were used to evaluate stimulation-related effects. Frequency of headache days decreased significantly in both the trapezius and the deltoid group after six sessions of rPMS (trapezius group: p = 0.005; deltoid group: p = 0.003). The MIDAS score decreased significantly from 29 to 13 points (p = 0.0004) in the trapezius and from 31 to 15 points (p = 0.002) in the deltoid group. Thus, rPMS applied to mTrPs of neck and shoulder muscles offers a promising approach to alleviate headache frequency and symptom burden. Future clinical trials are needed to examine more profoundly these effects, preferably using a sham-controlled setting.",2020,Frequency of headache days decreased significantly in both the trapezius and the deltoid group after six sessions of rPMS (trapezius group: p = 0.005; deltoid group: p = 0.003).,"['women between the age of 15 and 49 years', 'Thirty-seven subjects (age: 25.0\u2009±\u20094.1 years; 36 females) diagnosed with high-frequency episodic migraine who presented at least one active myofascial trigger point (mTrP) in the trapezius muscles and at least one latent mTrP']","['repetitive peripheral magnetic stimulation', 'Migraine', 'rPMS applied to the mTrPs of the trapezius (n\u2009=\u200919) or deltoid muscles', 'repetitive peripheral magnetic stimulation (rPMS']","['Frequency of headache days', 'MIDAS score', 'Migraine Disability Assessment (MIDAS) questionnaire']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0205275', 'cui_str': 'Latent'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}]","[{'cui': 'C0857361', 'cui_str': 'Headache occurring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1309950', 'cui_str': 'GOLPH3 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0193953,Frequency of headache days decreased significantly in both the trapezius and the deltoid group after six sessions of rPMS (trapezius group: p = 0.005; deltoid group: p = 0.003).,"[{'ForeName': 'Tabea', 'Initials': 'T', 'LastName': 'Renner', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Sollmann', 'Affiliation': 'Department of Diagnostic and Interventional Neuroradiology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany. Nico.Sollmann@tum.de.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Heinen', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Albers', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Trepte-Freisleder', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Klose', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'König', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}, {'ForeName': 'Sandro M', 'Initials': 'SM', 'LastName': 'Krieg', 'Affiliation': 'Department of Neurosurgery, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Michaela V', 'Initials': 'MV', 'LastName': 'Bonfert', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}, {'ForeName': 'Mirjam N', 'Initials': 'MN', 'LastName': 'Landgraf', 'Affiliation': ""Department of Pediatric Neurology and Developmental Medicine and LMU Center for Children with Medical Complexity, Dr. von Hauner Children's Hospital, LMU - University Hospital, Ludwig-Maximilians-Universität, Munich, Germany.""}]",Scientific reports,['10.1038/s41598-020-62701-9']
212,32249850,Effects of Lutein Supplementation in Japanese Patients with Unilateral Age-Related Macular Degeneration: The Sakai Lutein Study.,"This prospective randomized double-masked study investigated the effects of 20 mg lutein supplementation with two different capsules (beeswax or glycerol fatty acid esters) for 6 months on the fellow eyes of 39 Japanese patients with unilateral age-related macular degeneration, and assessed the factors associated with baseline plasma lutein concentration via lifestyle interviews. Macular pigment optical density (MPOD), determined with the two-wavelength autofluorescence method, increased over time in the beeswax group (ANOVA, p = 0.0451), although the increase from 3 months to 6 months was only marginally significant. No significant increase was observed in the glycerol fatty acid esters group (ANOVA, p = 0.7396). Plasma lutein concentrations significantly increased at 3 and 6 months from baseline in both groups (both p < 0.01). In a multiple regression model, age was negatively associated with higher plasma lutein concentration (p = 0.0305), while consumption of green vegetables was positively associated with baseline plasma lutein concentration (p = 0.0322). In conclusion, a significant increase in MPOD was not fully confirmed with 6 months intake duration despite a significant increase in plasma lutein concentrations. Consumption of green vegetable was confirmed to be associated with plasma lutein concentration after adjusting for other potential factors including age.",2020,Plasma lutein concentrations significantly increased at 3 and 6 months from baseline in both groups (both p < 0.01).,"['Japanese Patients with Unilateral Age-Related Macular Degeneration', '39 Japanese patients with unilateral age-related macular degeneration, and assessed the factors associated with baseline plasma lutein concentration via lifestyle interviews']","['Lutein Supplementation', '20\u2009mg lutein supplementation with two different capsules (beeswax or glycerol fatty acid esters']","['glycerol fatty acid esters', 'MPOD', 'plasma lutein concentrations', 'Plasma lutein concentrations', 'plasma lutein concentration', 'baseline plasma lutein concentration', 'Macular pigment optical density (MPOD']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0004924', 'cui_str': 'beeswax'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}]","[{'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0398595', 'cui_str': 'Myeloperoxidase deficiency'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0439164', 'cui_str': 'OD units'}]",39.0,0.0577036,Plasma lutein concentrations significantly increased at 3 and 6 months from baseline in both groups (both p < 0.01).,"[{'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Sawa', 'Affiliation': 'Eye Center, Sakai City Medical Center, Osaka, Japan. sawamikimd@gmail.com.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Shunto', 'Affiliation': 'Eye Center, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Nishiyama', 'Affiliation': 'Eye Center, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Yokoyama', 'Affiliation': 'Eye Center, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Ryujiro', 'Initials': 'R', 'LastName': 'Shigeta', 'Affiliation': 'Department of Ophthalmology, Osaka Habikino Medical Center, Osaka, Japan.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Miura', 'Affiliation': 'Eye Center, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Vision Informatics, Osaka University Graduate School of Medicine, Osaka, Japan.'}]",Scientific reports,['10.1038/s41598-020-62483-0']
213,31707107,Neurofeedback impacts cognition and quality of life in pediatric focal epilepsy: An exploratory randomized double-blinded sham-controlled trial.,"OBJECTIVE
Children with epilepsy experience cognitive deficits and well-being issues that have detrimental effects on their development. Pharmacotherapy is the standard of care in epilepsy; however, few interventions exist to promote cognitive development and to mitigate disease burden. We aimed to examine the impact of two different modalities of neurofeedback (NFB) on cognitive functioning and quality-of-life (QOL) measurements in children and adolescents with controlled focal epilepsy. The study also explored the effects of NFB on clinical outcomes and electroencephalography (EEG) quantitative analysis.
METHODS
Participants (n = 44) with controlled focal epilepsy were randomized to one of three arms: sensorimotor rhythm (SMR) NFB (n = 15), slow cortical potentials (SCP) NFB (n = 16), or sham NFB (n = 13). All participants received 25 sessions of intervention. The attention switching task (AST), Liverpool Seizure Severity Scale (LSSS), seizure frequency (SF), EEG power spectrum, and coherence were measured at baseline, postintervention, and at 3-month follow-up.
RESULTS
In children and adolescents with controlled focal epilepsy, SMR training significantly reduced reaction time in the AST (p = 0.006), and this was correlated with the difference of change for theta power on EEG (p = 0.03); only the SMR group showed a significant decrease in beta coherence (p = 0.03). All groups exhibited improvement in QOL (p = <0.05).
CONCLUSIONS
This study provides the first data on two NFB modalities (SMR and SCP) including cognitive, neurophysiological, and clinical outcomes in pediatric epilepsy. Sensorimotor rhythm NFB improved cognitive functioning, while all the interventions showed improvements in QOL, demonstrating a powerful placebo effect in the sham group.",2019,"All groups exhibited improvement in QOL (p = <0.05).
","['pediatric focal epilepsy', 'Participants (n\u202f=\u202f44) with controlled focal epilepsy', 'Children with epilepsy experience cognitive deficits', 'pediatric epilepsy', 'children and adolescents with controlled focal epilepsy']","['neurofeedback (NFB', 'Pharmacotherapy', 'NFB modalities (SMR and SCP', 'NFB', 'sensorimotor rhythm (SMR) NFB (n\u202f=\u202f15), slow cortical potentials (SCP) NFB (n\u202f=\u202f16), or sham NFB']","['reaction time', 'clinical outcomes and electroencephalography (EEG) quantitative analysis', 'Neurofeedback impacts cognition and quality of life', 'cognitive functioning', 'beta coherence', 'QOL', 'cognitive functioning and quality-of-life (QOL) measurements', 'attention switching task (AST), Liverpool Seizure Severity Scale (LSSS), seizure frequency (SF), EEG power spectrum, and coherence']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0014547', 'cui_str': 'Focal Seizure Disorder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.331688,"All groups exhibited improvement in QOL (p = <0.05).
","[{'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Morales-Quezada', 'Affiliation': 'Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA. Electronic address: jmorales-quezada@partners.org.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Boston Neurodynamics, Brookline, MA, USA; Neocemod, Centro de Neuromodulacion, Aguascalientes, Mexico.'}, {'ForeName': 'Mirret M', 'Initials': 'MM', 'LastName': 'El-Hagrassy', 'Affiliation': 'Neuromodulation Center, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies and Therapeutic Encounter, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'M Barry', 'Initials': 'MB', 'LastName': 'Sterman', 'Affiliation': 'Department of Neurobiology, UCLA School of Medicine, USA; Department of Biobehavioral Psychiatry, UCLA School of Medicine, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': ""Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Osher Center for Integrative Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106570']
214,32276980,A Mediterranean Diet Intervention Reduces the Levels of Salivary Periodontopathogenic Bacteria in Overweight and Obese Subjects.,"The human oral cavity is a complex ecosystem, and the alterations in salivary microbial communities are associated with both oral and nonoral diseases. The Mediterranean diet (MD) is a healthy dietary pattern useful for both prevention and treatment of several diseases. To further explore the effects of the MD on human health, in this study, we investigated the changes in the salivary microbial communities in overweight/obese subjects after an individually tailored MD-based nutritional intervention. Healthy overweight and obese subjects were randomized between two intervention groups. The MD group (Med-D group) increased their MD adherence during 8 weeks of intervention while the control diet (control-D) group did not change their dietary habits. The salivary microbiota was assessed at baseline and after 4 and 8 weeks of intervention. Despite no observed changes in the overall salivary microbiota composition, we found a significant decrease in the relative abundances of species-level operational taxonomic units annotated as Porphyromonas gingivalis , Prevotella intermedia , and Treponema denticola in the Med-D group compared to that in the control-D group after 8 weeks of intervention, which are known to be associated with periodontal disease. Such variations were significantly linked to dietary variables such as MD adherence rates and intakes of animal versus vegetable proteins. In addition, increased levels of Streptococcus cristatus were observed in the Med-D group, which has been reported as an antagonistic taxon inhibiting P. gingivalis gene expression. Our findings suggest that an MD-based nutritional intervention may be implicated in reducing periodontal bacteria, and an MD may be a dietary strategy supportive of oral homeostasis. IMPORTANCE Changes in dietary behavior with increased adherence to a Mediterranean diet can determine a reduction of periodontopathogenic bacterial abundances in the saliva of overweight subjects with cardiometabolic risk due to an unhealthy lifestyle, without any change in individual energy intake, nutrient intake, and physical activity.",2020,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"['overweight and obese subjects', 'Healthy overweight and obese subjects', 'overweight/obese subjects after an individually tailored MD-based nutritional intervention']","['Mediterranean diet intervention', 'Mediterranean diet (MD', 'MD']","['salivary microbiota', 'overall salivary microbiota composition', 'salivary periodontopathogenic bacteria', 'levels of Streptococcus cristatus', 'MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0318141', 'cui_str': 'Streptococcus cristatus'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0139182,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"[{'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Laiola', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it.'}]",Applied and environmental microbiology,['10.1128/AEM.00777-20']
215,32276987,First-line oxygen therapy with high-flow in bronchiolitis is not cost saving for the health service.,"BACKGROUND
Bronchiolitis is the most common reason for hospital admission in infants. High-flow oxygen therapy has emerged as a new treatment; however, the cost-effectiveness of using it as first-line therapy is unknown.
OBJECTIVE
To compare the cost of providing high-flow therapy as a first-line therapy compared with rescue therapy after failure of standard oxygen in the management of bronchiolitis.
METHODS
A within-trial economic evaluation from the health service perspective using data from a multicentre randomised controlled trial for hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand. Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733). Costs were applied using Australian costing sources and are reported in 2016-2017 AU$.
RESULTS
The incremental cost to avoid one treatment failure was AU$1778 (95% credible interval (CrI) 207 to 7096). Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay was AU$420 (95% CrI -176 to 1002) higher per infant in the early high-flow group compared with the rescue high-flow group. There was an 8% (95% CrI 7.5 to 8.6) likelihood of the early high-flow oxygen therapy being cost saving.
CONCLUSIONS
The use of high-flow oxygen as initial therapy for respiratory failure in infants with bronchiolitis is unlikely to be cost saving to the health system, compared with standard oxygen therapy with rescue high-flow.",2020,"Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733).","['hospital admission in infants', 'hypoxic infants (≤12 months) admitted to hospital with bronchiolitis in Australia and New Zealand', 'infants with bronchiolitis']","['High-flow oxygen therapy', 'standard oxygen and optional rescue high-flow']","['Mean cost of bronchiolitis treatment including intervention costs and costs associated with length of stay', 'Intervention costs, length of hospital and intensive care stay and associated costs']","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0001311', 'cui_str': 'Acute bronchiolitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.0885389,"Intervention costs, length of hospital and intensive care stay and associated costs were compared for infants who received first-line treatment with high-flow therapy (early high-flow, n=739) or for infants who received standard oxygen and optional rescue high-flow (rescue high-flow, n=733).","[{'ForeName': 'Vijay S', 'Initials': 'VS', 'LastName': 'Gc', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Franklin', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Whitty', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Dalziel', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Franz E', 'Initials': 'FE', 'LastName': 'Babl', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Luregn J', 'Initials': 'LJ', 'LastName': 'Schlapbach', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Fraser', 'Affiliation': 'The University of Queensland Child Health Research Centre, School of Medicine, Brisbane, Queensland, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Neutze', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Oakley', 'Affiliation': 'Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schibler', 'Affiliation': 'Paediatric Critical Care Research Group, The University of Queensland Child Health Research Centre, South Brisbane, Queensland, Australia a.schibler@uq.edu.au.'}]",Archives of disease in childhood,['10.1136/archdischild-2019-318427']
216,32280092,"Ca:Mg Ratio, APOE Cytosine Modifications, and Cognitive Function: Results from a Randomized Trial.","BACKGROUND
Deterioration of ionized calcium (Ca2+) handling in neurons could lead to neurodegenerative disease. Magnesium (Mg) antagonizes Ca during many physiologic activities, including energy metabolism and catalyzation of demethylation from 5-methylcytosine(5-mC) to 5-hydroxymethylcytosine(5-hmC).
OBJECTIVE
To test the hypothesis that actively reducing the Ca:Mg intake ratio in the diet through Mg supplementation improves cognitive function, and to test whether this effect is partially mediated by modified cytosines in Apolipoprotein E (APOE).
METHODS
This study is nested within the Personalized Prevention of Colorectal Cancer Trial (PPCCT), a double-blind 2×2 factorial randomized controlled trial, which enrolled 250 participants from Vanderbilt University Medical Center. Target doses for both Mg and placebo arms were personalized.
RESULTS
Among those aged > 65 years old who consumed a high Ca:Mg ratio diet, we found that reducing the Ca:Mg ratio to around 2.3 by personalized Mg supplementation significantly improved cognitive function by 9.1% (p = 0.03). We also found that reducing the Ca:Mg ratio significantly reduced 5-mC at the cg13496662 and cg06750524 sites only among those aged > 65 years old (p values = 0.02 and 0.03, respectively). Furthermore, the beneficial effect of reducing the Ca:Mg ratio on cognitive function in those aged over 65 years was partially mediated by reductions in 5-mC levels (i.e., cg13496662 and cg06750524) in APOE (p for indirect effect = 0.05).
CONCLUSION
Our findings suggest that, among those age 65 and over with a high dietary Ca:Mg ratio, optimal Mg status may improve cognitive function partially through modifications in APOE methylation. These findings, if confirmed, have significant implications for the prevention of cognitive aging and Alzheimer's disease.Clinical Trial Registry number and website: #100106 https://clinicaltrials.gov/ct2/show/NCT03265483.",2020,"We also found that reducing the Ca:Mg ratio significantly reduced 5-mC at the cg13496662 and cg06750524 sites only among those aged > 65 years old (p values = 0.02 and 0.03, respectively).","['enrolled 250 participants from Vanderbilt University Medical Center', 'Among those aged\u200a>\u200a65 years old who consumed a high Ca']","['ionized calcium (Ca2', 'Magnesium (Mg) antagonizes Ca', 'placebo']","['5-mC levels', 'cognitive function', 'Ca:Mg ratio significantly reduced 5-mC', 'Ca:Mg ratio']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0049308', 'cui_str': '5-Methylcytosine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",250.0,0.121845,"We also found that reducing the Ca:Mg ratio significantly reduced 5-mC at the cg13496662 and cg06750524 sites only among those aged > 65 years old (p values = 0.02 and 0.03, respectively).","[{'ForeName': 'Xiangzhu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Division of Epidemiology, Vanderbilt Epidemiology Center, Vanderbilt University School of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amy R', 'Initials': 'AR', 'LastName': 'Borenstein', 'Affiliation': 'Department of Family Medicine and Public Health, Division of Epidemiology, University of California-San Diego School of Medicine, La Jolla, CA, USA.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Seidner', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Vanderbilt School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Ness', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Vanderbilt School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Murff', 'Affiliation': 'Division of Geriatric Medicine, General Internal Medicine and Public Health, Vanderbilt University School of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Bingshan', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Shrubsole', 'Affiliation': 'Department of Medicine, Division of Epidemiology, Vanderbilt Epidemiology Center, Vanderbilt University School of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Hou', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Medicine, Division of Epidemiology, Vanderbilt Epidemiology Center, Vanderbilt University School of Medicine, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-191223']
217,30476251,Atorvastatin Treatment of Cavernous Angiomas with Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial.,"BACKGROUND
More than a million Americans harbor a cerebral cavernous angioma (CA), and those who suffer a prior symptomatic hemorrhage have an exceptionally high rebleeding risk. Preclinical studies show that atorvastatin blunts CA lesion development and hemorrhage through inhibiting RhoA kinase (ROCK), suggesting it may confer a therapeutic benefit.
OBJECTIVE
To evaluate whether atorvastatin produces a difference compared to placebo in lesional iron deposition as assessed by quantitative susceptibility mapping (QSM) on magnetic resonance imaging in CAs that have demonstrated a symptomatic hemorrhage in the prior year. Secondary aims shall assess effects on vascular permeability, ROCK activity in peripheral leukocytes, signal effects on clinical outcomes, adverse events, and prespecified subgroups.
METHODS
The phase I/IIa placebo-controlled, double-blinded, single-site clinical trial aims to enroll 80 subjects randomized 1-1 to atorvastatin (starting dose 80 mg PO daily) or placebo. Dosing shall continue for 24-mo or until reaching a safety endpoint.
EXPECTED OUTCOMES
The trial is powered to detect an absolute difference of 20% in the mean percent change in lesional QSM per year (2-tailed, power 0.9, alpha 0.05). A decrease in QSM change would be a signal of potential benefit, and an increase would signal a safety concern with the drug.
DISCUSSION
With firm mechanistic rationale, rigorous preclinical discoveries, and biomarker validations, the trial shall explore a proof of concept effect of a widely used repurposed drug in stabilizing CAs after a symptomatic hemorrhage. This will be the first clinical trial of a drug aimed at altering rebleeding in CA.",2019,"Preclinical studies show that atorvastatin blunts CA lesion development and hemorrhage through inhibiting RhoA kinase (ROCK), suggesting it may confer a therapeutic benefit.
",[],"['atorvastatin', 'Atorvastatin', 'placebo']","['vascular permeability, ROCK activity', 'QSM change']",[],"[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0162337', 'cui_str': 'Vascular Permeability'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",80.0,0.551617,"Preclinical studies show that atorvastatin blunts CA lesion development and hemorrhage through inhibiting RhoA kinase (ROCK), suggesting it may confer a therapeutic benefit.
","[{'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Polster', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Stadnik', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Akers', 'Affiliation': 'Angioma Alliance, Norfolk, Virginia.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Christoforidis', 'Affiliation': 'Department of Diagnostic Radiology, The University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Maged D', 'Initials': 'MD', 'LastName': 'Fam', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Flemming', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Romuald', 'Initials': 'R', 'LastName': 'Girard', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hobson', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'James I', 'Initials': 'JI', 'LastName': 'Koenig', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Koskimäki', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Liao', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago Medical Center, Illinois.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Angioma Alliance, Norfolk, Virginia.'}, {'ForeName': 'Seán B', 'Initials': 'SB', 'LastName': 'Lyne', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, Maryland.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Morrison', 'Affiliation': 'Department of Neurology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Piedad', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Shenkar', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sorrentino', 'Affiliation': 'Section of Cardiology, Department of Medicine, The University of Chicago Medical Center, Illinois.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Whitehead', 'Affiliation': 'Department of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Hussein A', 'Initials': 'HA', 'LastName': 'Zeineddine', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': 'Division of Brain Injury Outcomes, Department of Neurology, Johns Hopkins University Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Issam A', 'Initials': 'IA', 'LastName': 'Awad', 'Affiliation': 'Neurovascular Surgery Program, Section of Neurosurgery, Department of Surgery, University of Chicago Medicine and Biological Sciences, Chicago, Illinois.'}]",Neurosurgery,['10.1093/neuros/nyy539']
218,32279888,Protection of an intraoral surgical wound with a new dressing: a randomised controlled clinical trial.,"Operations that involve the maxillofacial region often require intraoral incisions, and contamination of these wounds is common as a result of the presence of saliva, plaque, and food debris. Postoperative infection is therefore common. The aim of the study was to evaluate the clinical efficacy of an intraoral dressing material, Reso-Pac®, in improving postoperative comfort for patients and its effect on wound healing. One hundred patients who required removal of impacted mandibular third molars were recruited, and were randomised into two groups (50 in each). A standardised surgical technique was used for removal of the impacted teeth, and wounds were closed with sutures. Postoperatively, the study group was given Reso-Pac® dressing while the control group was not. Postoperative pain was measured using a visual analogue scale (VAS). Wound healing was assessed with the help of Landry's scale, and we also measured thermal sensitivity. Data were analysed using the paired t test. The results in the study group were significantly better than those in the control group (p<0.001). Reso-Pac® promoted wound healing and improved patients' comfort during the postoperative phase.",2020,The results in the study group were significantly better than those in the control group (p<0.001).,['One hundred patients who required removal of impacted mandibular third molars'],"['intraoral dressing material, Reso-Pac®', 'intraoral surgical wound with a new dressing']","['Postoperative pain', 'visual analogue scale (VAS', 'Wound healing', 'wound healing', 'clinical efficacy']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",100.0,0.0440613,The results in the study group were significantly better than those in the control group (p<0.001).,"[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Raghavan', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Panneerselvam', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India. Electronic address: elavenilomfs@gmail.com.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Mudigonda', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India.'}, {'ForeName': 'K K V B', 'Initials': 'KKVB', 'LastName': 'Raja', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, SRM Dental College and Hospital, Bharathi Salai, Ramapuram Campus, Ramapuram, Chennai 600089, Tamil Nadu, India.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.03.017']
219,32277977,The influence of prolonged strength training upon muscle and fat in healthy and chronically diseased older adults.,"BACKGROUND
Physical muscle function and brain hippocampus size declines with age, accelerating after the age of 60. Strength training over a few months improves physical function, but less is known about how long-term strength training affects physical function and hippocampus volume. Therefore, we aimed to investigate the effect of 1-year strength training of two different intensities upon muscle mass, function, and hippocampus volume in retirement-age individuals.
METHODS
In this multidisciplinary randomized controlled trial (clinicaltrials.gov: NCT02123641), participants were allocated to either a) supervised, heavy resistance training (HRT, n = 149, 3/wk), b) moderate intensity resistance training (MIT, n = 154, 3/wk) or c) non-exercise activities (CON, n = 148). 451 participants were randomized (62-70 yrs., women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n = 143, 144 and 132; HRT, MIT and CON). Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed.
FINDINGS
Of the participants (HRT + MIT), 83% completed training at least 2/week. Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only. Further, chair-stand performance improved in all groups, whereas hippocampus volume decreased in all groups over time with no influence of strength training.
INTERPRETATION
Together, the results indicate that leg extensor power did not respond to long-term supervised strength training, but this type of training in a mixed group of healthy and chronically diseased elderly individuals can be implemented with good compliance and induces consistent changes in physiological parameters of muscle strength, muscle mass and abdominal fat.",2020,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","['retirement-age individuals', ' women 61%, ≈80% with a chronic medical disease) and 419 were included in the intention-to-treat analysis (n\u202f=\u202f143, 144 and 132; HRT, MIT and CON', '451 participants were randomized (62-70\u202fyrs', 'healthy and chronically diseased older adults']","['heavy resistance training (HRT, n\u202f=\u202f149, 3/wk), b) moderate intensity resistance training (MIT, n\u202f=\u202f154, 3/wk) or c) non-exercise activities (CON, n\u202f=\u202f148', 'prolonged strength training', 'Strength training']","['Changes in muscle power (primary outcome), strength and size, physical function, body composition, hippocampus volume and physical/mental well-being were analyzed', 'hippocampus volume', 'increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36', 'Leg extensor power', 'physical function', 'chair-stand performance', 'isometric knee extensor strength']","[{'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]",451.0,0.032446,"Leg extensor power was unchanged in all groups, but strength training had a positive effect on isometric knee extensor strength in both groups, whereas an increased muscle mass, cross-sectional area of vastus lateralis muscle, a decreased whole-body fat percentage, visceral fat content and an improved mental health (SF-36) occurred in HRT only.","[{'ForeName': 'Anne Theil', 'Initials': 'AT', 'LastName': 'Gylling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark. Electronic address: anne.theil.gylling@regionh.dk.'}, {'ForeName': 'Christian Skou', 'Initials': 'CS', 'LastName': 'Eriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Garde', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Cathrine Lawaetz', 'Initials': 'CL', 'LastName': 'Wimmelmann', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Nina Linde', 'Initials': 'NL', 'LastName': 'Reislev', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Physical and Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Andreas Kraag', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kasper Winther', 'Initials': 'KW', 'LastName': 'Andersen', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Technology, University College Copenhagen, Sigurdsgade 26, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Dideriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baekgaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Kenneth Hudlebusch', 'Initials': 'KH', 'LastName': 'Mertz', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Monika Lucia', 'Initials': 'ML', 'LastName': 'Bayer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bloch-Ibenfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Radiation Sciences, Umeå University, S-901 87 Umeå, Sweden.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark; Department of Neurology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Centre for Translational Research, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen, NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen, N, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2020.110939']
220,32242355,Timing of Endoscopy for Acute Upper Gastrointestinal Bleeding.,"BACKGROUND
It is recommended that patients with acute upper gastrointestinal bleeding undergo endoscopy within 24 hours after gastroenterologic consultation. The role of endoscopy performed within time frames shorter than 24 hours has not been adequately defined.
METHODS
To evaluate whether urgent endoscopy improves outcomes in patients predicted to be at high risk for further bleeding or death, we randomly assigned patients with overt signs of acute upper gastrointestinal bleeding and a Glasgow-Blatchford score of 12 or higher (scores range from 0 to 23, with higher scores indicating a higher risk of further bleeding or death) to undergo endoscopy within 6 hours (urgent-endoscopy group) or between 6 and 24 hours (early-endoscopy group) after gastroenterologic consultation. The primary end point was death from any cause within 30 days after randomization.
RESULTS
A total of 516 patients were enrolled. The 30-day mortality was 8.9% (23 of 258 patients) in the urgent-endoscopy group and 6.6% (17 of 258) in the early-endoscopy group (difference, 2.3 percentage points; 95% confidence interval [CI], -2.3 to 6.9). Further bleeding within 30 days occurred in 28 patients (10.9%) in the urgent-endoscopy group and in 20 (7.8%) in the early-endoscopy group (difference, 3.1 percentage points; 95% CI, -1.9 to 8.1). Ulcers with active bleeding or visible vessels were found on initial endoscopy in 105 of the 158 patients (66.4%) with peptic ulcers in the urgent-endoscopy group and in 76 of 159 (47.8%) in the early-endoscopy group. Endoscopic hemostatic treatment was administered at initial endoscopy for 155 patients (60.1%) in the urgent-endoscopy group and for 125 (48.4%) in the early-endoscopy group.
CONCLUSIONS
In patients with acute upper gastrointestinal bleeding who were at high risk for further bleeding or death, endoscopy performed within 6 hours after gastroenterologic consultation was not associated with lower 30-day mortality than endoscopy performed between 6 and 24 hours after consultation. (Funded by the Health and Medical Fund of the Food and Health Bureau, Government of Hong Kong Special Administrative Region; ClinicalTrials.gov number, NCT01675856.).",2020,"Endoscopic hemostatic treatment was administered at initial endoscopy for 155 patients (60.1%) in the urgent-endoscopy group and for 125 (48.4%) in the early-endoscopy group.
","['patients with acute upper gastrointestinal bleeding undergo endoscopy within 24 hours after gastroenterologic consultation', 'patients predicted to be at high risk for further bleeding or death, we randomly assigned patients with overt signs of acute upper gastrointestinal bleeding and a Glasgow-Blatchford score of 12 or higher (scores range from 0 to 23, with higher scores indicating a higher risk of further bleeding or death) to undergo endoscopy within 6 hours (urgent-endoscopy group) or between 6 and 24 hours (early-endoscopy group) after gastroenterologic consultation', '516 patients were enrolled']",['Endoscopic hemostatic treatment'],"['death', 'peptic ulcers', 'Ulcers with active bleeding or visible vessels', '30-day mortality', 'Further bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266809', 'cui_str': 'Acute upper gastrointestinal hemorrhage'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",516.0,0.0981341,"Endoscopic hemostatic treatment was administered at initial endoscopy for 155 patients (60.1%) in the urgent-endoscopy group and for 125 (48.4%) in the early-endoscopy group.
","[{'ForeName': 'James Y W', 'Initials': 'JYW', 'LastName': 'Lau', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Raymond S Y', 'Initials': 'RSY', 'LastName': 'Tang', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Heyson C H', 'Initials': 'HCH', 'LastName': 'Chan', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Hon-Chi', 'Initials': 'HC', 'LastName': 'Yip', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Chan', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sally W Y', 'Initials': 'SWY', 'LastName': 'Luk', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sunny H', 'Initials': 'SH', 'LastName': 'Wong', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Louis H S', 'Initials': 'LHS', 'LastName': 'Lau', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Rashid N', 'Initials': 'RN', 'LastName': 'Lui', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Ting T', 'Initials': 'TT', 'LastName': 'Chan', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Joyce W Y', 'Initials': 'JWY', 'LastName': 'Mak', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Francis K L', 'Initials': 'FKL', 'LastName': 'Chan', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Joseph J Y', 'Initials': 'JJY', 'LastName': 'Sung', 'Affiliation': 'From the Institute of Digestive Disease, the Chinese University of Hong Kong, Shatin, Hong Kong.'}]",The New England journal of medicine,['10.1056/NEJMoa1912484']
221,30948254,Effect of two tourniquet techniques on peripheral intravenous cannulation success: A randomized controlled trial.,"OBJECTIVES
Peripheral intravenous (IV) cannulation is the most common procedure performed in the emergency department (ED). Elastic tourniquets (ETs) and blood pressure cuffs (BPCs) are frequently used for venodilation. Although BPCs lead to increased venodilation and decreased compressibility, it is unclear whether this translates into a meaningful patient-centered outcome. This study aimed to determine whether one method is superior for success on the first attempt.
METHODS
This was a prospective, single-blinded, randomized controlled trial in the ED of a tertiary care center. A convenience sample of adult patients was randomly assigned to an ET or BPC with a cover concealing the type of tourniquet. The primary outcome was success rate on the first attempt. Secondary outcomes were number of attempts, number of providers, and rate of rescue techniques.
RESULTS
Of the 121 patients enrolled, 119 qualified for analysis. In the ET group, 42 of 59 patients (71%) had successful IV cannulation on first attempt compared with 43 of 60 (72%) in the BPC group (P = .95). The number of attempts (P = .87), number of nurses (P = .67), and use of rescue techniques (P = .32) did not differ significantly. A history of difficult IV access and site other than the antecubital vein were associated with decreased success.
CONCLUSIONS
ETs and BPCs performed similarly in providing venodilation for successful peripheral IV cannulation. History of difficult IV access and IV site are important factors in determining the likelihood of success.",2019,"The number of attempts (P = .87), number of nurses (P = .67), and use of rescue techniques (P = .32) did not differ significantly.","['121 patients enrolled, 119 qualified for analysis', 'A convenience sample of adult patients']","['ET or BPC', 'tourniquet techniques', 'Peripheral intravenous (IV) cannulation']","['successful IV cannulation', 'number of nurses', 'peripheral intravenous cannulation success', 'number of attempts, number of providers, and rate of rescue techniques', 'Elastic tourniquets (ETs) and blood pressure cuffs (BPCs', 'success rate on the first attempt']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0398266', 'cui_str': 'Introduction of catheter into vein'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0398266', 'cui_str': 'Introduction of catheter into vein'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff, device (physical object)'}]",121.0,0.196793,"The number of attempts (P = .87), number of nurses (P = .67), and use of rescue techniques (P = .32) did not differ significantly.","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, United States of America.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Lund', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Micah D', 'Initials': 'MD', 'LastName': 'Nichols', 'Affiliation': 'Bethel University, St Paul, MN, United States of America.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kummer', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN, United States of America. Electronic address: kummer.tobias@mayo.edu.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.03.034']
222,32277519,Improving emotion recognition in anorexia nervosa: An experimental proof-of-concept study.,"OBJECTIVE
Previous research has found increasing evidence for difficulties in emotion recognition ability (ERA) and social cognition in anorexia nervosa (AN), and recent models consider these factors to contribute to the development and maintenance of the disorder. However, there is a lack of experimental studies testing this hypothesis. Therefore, the present proof-of-concept study examined whether ERA can be improved by a single session of a computerized training in AN, and whether this has short-term effects on eating disorder symptoms.
METHOD
Forty inpatients (22.20 ± 7.15 years) with AN were randomly assigned to receive a single session of computerized training of ERA (TERA) or a sham training (training the recognition of different types of clouds). ERA, self-reported eating disorder symptoms, and body mass index (BMI) were assessed within 3 days before and after training.
RESULTS
After training, both groups showed improved ERA, reduced self-reported eating disorder symptoms, and an increased BMI. As compared to patients in the control group, patients who received TERA showed greater improvements in ERA and self-reported eating disorder symptoms.
DISCUSSION
ERA can be effectively trained in patients with AN. Moreover, short-term improvements in self-reported eating disorder symptoms provide tentative support for the hypothesis that difficulties in ERA contribute to the maintenance of AN, and that specific trainings of ERA hold promise as an additional component in AN treatment. Future studies are needed to replicate these findings in larger samples, and to investigate long-term effects and transfer into real-world settings.",2020,"As compared to patients in the control group, patients who received TERA showed greater improvements in ERA and self-reported eating disorder symptoms.
","['Forty inpatients (22.20\u2009±\u20097.15\u2009years) with AN', 'anorexia nervosa', 'patients with AN']","['computerized training of ERA (TERA) or a sham training (training the recognition of different types of clouds', 'TERA']","['BMI', 'ERA, self-reported eating disorder symptoms, and body mass index (BMI', 'ERA and self-reported eating disorder symptoms', 'improved ERA, reduced self-reported eating disorder symptoms', 'emotion recognition']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}]",40.0,0.0161913,"As compared to patients in the control group, patients who received TERA showed greater improvements in ERA and self-reported eating disorder symptoms.
","[{'ForeName': 'Mira A', 'Initials': 'MA', 'LastName': 'Preis', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Schlegel', 'Affiliation': 'Institute of Psychology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stoll', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Blomberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Schmidt', 'Affiliation': 'Klinik Lüneburger Heide, Bad Bevensen, Germany.'}, {'ForeName': 'Wally', 'Initials': 'W', 'LastName': 'Wünsch-Leiteritz', 'Affiliation': 'Klinik Lüneburger Heide, Bad Bevensen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Leiteritz', 'Affiliation': 'Klinik Lüneburger Heide, Bad Bevensen, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Brockmeyer', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Goettingen, Goettingen, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23276']
223,30835626,"Predicting early emotion knowledge development among children of colour living in historically disinvested neighbourhoods: consideration of child pre-academic abilities, self-regulation, peer relations and parental education.","Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems. Less is known, however, about predictors of early development of emotion knowledge. This study examines emotion knowledge development among children attending pre-Kindergarten and Kindergarten programmes in high-poverty urban schools. The study considers child pre-academic abilities, self-regulation, peer relations and parental education as predictors of emotion knowledge development over two years. The sample ( n = 1034) of children living in historically disinvested neighbourhoods was primarily Black (85%) and low-income (∼61%). The sample was part of a longitudinal follow-up study of a cluster (school) randomised controlled trial in ten public elementary schools. Children's emotion knowledge was assessed with a series of tasks three times over a two-year period. At baseline, parents and teachers reported on peer relations, children completed a test of pre-academic abilities, independent observers rated child self-regulation, and parents reported on their educational attainment. Results demonstrate that emotion knowledge increases over time, and pre-academic abilities, self-regulation, peer relations, and parent education independently predict children's emotion knowledge. This study highlights multiple factors that predict emotion knowledge among primarily Black children living in historically disinvested neighbourhoods.",2019,"Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems.","['children attending pre-Kindergarten and Kindergarten programmes in high-poverty urban schools', 'The sample (n\u2009=\u20091034) of children living in historically disinvested neighbourhoods was primarily Black (85%) and low-income (∼61', 'primarily Black children living in historically disinvested neighbourhoods', 'children of colour living in historically disinvested neighbourhoods', 'ten public elementary schools']",[],"['emotion knowledge development', 'Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems', ""emotion knowledge increases over time, and pre-academic abilities, self-regulation, peer relations, and parent education independently predict children's emotion knowledge"", ""Children's emotion knowledge""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0683256', 'cui_str': 'Social Competence'}, {'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0242261', 'cui_str': 'Parenting Education'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",10.0,0.0157764,"Emotion knowledge, the ability to accurately perceive and label emotions, predicts higher quality peer relations, higher social competence, higher academic achievement, and fewer behaviour problems.","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ursache', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}, {'ForeName': 'Spring', 'Initials': 'S', 'LastName': 'Dawson-McClure', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Siegel', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}, {'ForeName': 'Laurie Miller', 'Initials': 'LM', 'LastName': 'Brotman', 'Affiliation': 'Department of Population Health, NYU School of Medicine , New\xa0York , NY , USA.'}]",Cognition & emotion,['10.1080/02699931.2019.1587388']
224,30847689,"Diagnostic, clinical, and personality correlates of food anxiety during a food exposure in patients diagnosed with an eating disorder.","BACKGROUND
Eating disorders are characterized by high levels of anxiety, especially while eating. However, little is known about anxiety experienced during meals and specifically what other variables may impact such anxiety.
OBJECTIVE
We sought to further quantify and understand the relationship between food anxiety, eating disorders, and related correlates (e.g., comorbid diagnoses, personality).
METHODS
In the current study [N = 42 participants diagnosed with an eating disorder (n = 36 participants with anorexia nervosa)], we quantified anxiety before, during, and after a meal using data from a food exposure session in a partial hospital eating disorder center. We examined diagnostic, personality, and clinical factors as correlates of food anxiety.
RESULTS
Participants were more likely to experience higher food anxiety if they had a current diagnosis of major depression, obsessive-compulsive disorder, or post-traumatic stress disorder (PTSD). Concern over mistakes was the strongest and most consistent correlate of food anxiety regardless of time during the meal that anxiety was assessed. Other significant correlates were fear of positive evaluation, social appearance anxiety, BMI, and trust.
CONCLUSIONS
These findings show how diagnoses, perfectionism (concern over mistakes), and other correlates relate to anxiety during meals. Food exposure interventions may benefit from personalizations that address these factors.
LEVEL OF EVIDENCE
IV Evidence from a randomized control trial, but from the first session before effects of the design would be present.",2019,Concern over mistakes was the strongest and most consistent correlate of food anxiety regardless of time during the meal that anxiety was assessed.,"['partial hospital eating disorder center', 'patients diagnosed with an eating disorder', '42 participants diagnosed with an eating disorder (n\u2009=\u200936 participants with anorexia nervosa']",['Food exposure interventions'],"['fear of positive evaluation, social appearance anxiety, BMI, and trust']","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]",42.0,0.0772993,Concern over mistakes was the strongest and most consistent correlate of food anxiety regardless of time during the meal that anxiety was assessed.,"[{'ForeName': 'Cheri A', 'Initials': 'CA', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Louisville, Louisville, KY, 40292, USA. cheri.levinson@louisville.edu.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Sala', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Louisville, Louisville, KY, 40292, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Rodebaugh', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University, St. Louis, MO, USA.'}]",Eating and weight disorders : EWD,['10.1007/s40519-019-00669-w']
225,32277701,Protective Effectiveness of Long-Lasting Permethrin Impregnated Clothing Against Tick Bites in an Endemic Lyme Disease Setting: A Randomized Control Trial Among Outdoor Workers.,"Tick-borne diseases are a growing threat to public health in the United States, especially among outdoor workers who experience high occupational exposure to ticks. Long-lasting permethrin-impregnated clothing has demonstrated high initial protection against bites from blacklegged ticks, Ixodes scapularis Say (Acari: Ixodidae), in laboratory settings, and sustained protection against bites from the lone star tick, Amblyomma americanum (L.) (Acari: Ixodidae), in field tests. However, long-lasting permethrin impregnation of clothing has not been field tested among outdoor workers who are frequently exposed to blacklegged ticks. We conducted a 2-yr randomized, placebo-controlled, double-blinded trial among 82 outdoor workers in Rhode Island and southern Massachusetts. Participants in the treatment arm wore factory-impregnated permethrin clothing, and the control group wore sham-treated clothing. Outdoor working hours, tick encounters, and bites were recorded weekly to assess protective effectiveness of long-lasting permethrin-impregnated garments. Factory-impregnated clothing significantly reduced tick bites by 65% in the first study year and by 50% in the second year for a 2-yr protective effect of 58%. No significant difference in other tick bite prevention method utilization occurred between treatment and control groups, and no treatment-related adverse outcomes were reported. Factory permethrin impregnation of clothing is safe and effective for the prevention of tick bites among outdoor workers whose primary exposure is to blacklegged ticks in the northeastern United States.",2020,Factory permethrin impregnation of clothing is safe and effective for the prevention of tick bites among outdoor workers whose primary exposure is to blacklegged ticks in the northeastern United States.,"['Outdoor Workers', '82 outdoor workers in Rhode Island and southern Massachusetts', 'Endemic Lyme Disease Setting']","['factory-impregnated permethrin clothing, and the control group wore sham-treated clothing', 'Factory-impregnated clothing', 'Long-Lasting Permethrin Impregnated Clothing Against Tick Bites', 'placebo']","['Outdoor working hours, tick encounters, and bites', 'tick bites', 'tick bite prevention method utilization']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0024198', 'cui_str': 'Lyme disease'}]","[{'cui': 'C0442614', 'cui_str': 'Factory'}, {'cui': 'C0070455', 'cui_str': 'Permethrin'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0241407', 'cui_str': 'Tick bite'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040203', 'cui_str': 'Ixodida'}, {'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0241407', 'cui_str': 'Tick bite'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",82.0,0.0336202,Factory permethrin impregnation of clothing is safe and effective for the prevention of tick bites among outdoor workers whose primary exposure is to blacklegged ticks in the northeastern United States.,"[{'ForeName': 'Cedar', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Dyer', 'Affiliation': 'Center for Vector-Borne Disease, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Feng-Chang', 'Initials': 'FC', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bowman', 'Affiliation': 'Division of Infectious Diseases, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mather', 'Affiliation': 'Center for Vector-Borne Disease, University of Rhode Island, Kingston, RI.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Meshnick', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC.'}]",Journal of medical entomology,['10.1093/jme/tjaa061']
226,31590108,Randomized controlled trial of cryotherapy to prevent paclitaxel-induced peripheral neuropathy (RU221511I); an ACCRU trial.,"PURPOSE
This pilot trial aimed to assess if cooling hands and feet with crushed ice during receipt of paclitaxel helps prevent peripheral neuropathy.
METHODS
This prospective, randomized trial compared cryotherapy to standard care in patients initiating paclitaxel weekly x 12. For those on cryotherapy, hands and feet were cooled starting 15 min prior to and ending 15 min after each paclitaxel dose. EORTC QLQ-CIPN20 was completed at baseline, weekly x12, then monthly x6. Area under the curve (AUC) was calculated for subscale scores, adjusting for baseline, and compared between arms (Wilcoxon rank-sum test). Cross-study comparisons used data from 2 prior similarly-conducted neuropathy trials.
RESULTS
Forty-six patients were accrued. Three withdrew and one was ineligible. Of the remaining 42 (21 cryotherapy, 21 control), 39 (19 cryotherapy, 20 control) were analyzable for AUC. Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26). However, the control arm of the current trial experienced less neuropathy than did the placebo arms of two previous similar trials. When our cryotherapy arm was compared to the combined control arms from all three trials, the cryotherapy arm had less neuropathy (Wilcoxon Rank-Sum p = 0.01).
CONCLUSION
While there was no difference in CIPN20 scores identified between the 2 study arms in the current phase II trial, further investigation is needed given that the control arm experienced less neuropathy than was expected.",2019,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","['patients initiating paclitaxel weekly x 12', 'Forty-six patients were accrued']","['Cryotherapy', 'placebo', 'cryotherapy', 'paclitaxel']","['CIPN20 scores', 'Area under the curve (AUC', 'CIPN20 sensory scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}]",46.0,0.0622765,"Cryotherapy was well tolerated, but the AUC of the CIPN20 sensory scores over 12 weeks of paclitaxel was not found to differ between the study arms (mean difference 3.45, 95% CI -3.13 to 10.02, p = 0.26).","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA. Electronic address: Ruddy.kathryn@mayo.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Mario E', 'Initials': 'ME', 'LastName': 'Lacouture', 'Affiliation': 'Department of Dermatology, Memorial Sloan Kettering Cancer Center, 1275 York Ave., New York, NY, 10065, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Wilkinson', 'Affiliation': 'Inova Hematology Oncology, 8501 Arlington Blvd., Suite 340, Fairfax, VA, 22031, USA.'}, {'ForeName': 'Adedayo A', 'Initials': 'AA', 'LastName': 'Onitilo', 'Affiliation': 'Marshfield Clinic - Weston Center, 3501 Cranberry Blvd., Weston, WI, 54476, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Vander Woude', 'Affiliation': 'Cancer and Hematology Centers of Western Michigan, 145 Michigan St. NE, #3100, Grand Rapids, MI, 49503, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Grosse-Perdekamp', 'Affiliation': 'Carle Cancer Center, 509 W. University Ave., Urbana, IL, 61801, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Dockter', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Angelina D', 'Initials': 'AD', 'LastName': 'Tan', 'Affiliation': 'Department of Biostatistics, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Beutler', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2019.09.011']
227,31780003,Using a cultural dance program to increase sustainable physical activity for breast cancer survivors-A pilot study.,"BACKGROUND
Studies have shown that physical activity can reduce the risk of mortality for female breast cancer patients and improve quality of life, reduce weight, and alter circulating biomarker levels. We conducted a pilot trial to determine the feasibility of increasing physical activity through a cultural dance intervention to achieve similar benefits.
METHODS
Conducted a pilot trial implementing a cultural dance intervention to increase and sustain physical activity for breast cancer survivors, which consisted of a six-month group-based intervention of Hula Dance. Anthropometric measures, fasting blood draws, and self-reported questionnaires to assess physical activity, mood, and quality of life, were completed at baseline, at the end of the 6-month intervention (time point month-6), and at two additional post-intervention time points (month-12 and month-24) to assess sustainability.
RESULTS
A total of 11 women with a median age of 63 years were enrolled in the intervention trial. Eight of the 11 (73%) completed the trial to month-12 and demonstrated an overall significant increase in weekly moderate exercise. There were no significant changes in intra-individual body mass index (BMI). However, there was a sustained post-intervention reduction in waist circumference and significant changes in circulating biomarker levels. For the self-reported measures, there was a significant increase in vigor/activity (p < 0.001; Profile of Mood States-Short Form).
CONCLUSION
Our intervention pilot trial demonstrated that a cultural dance program could achieve a sustainable increase in physical activity for breast cancer survivors, with potential to improve quality of life, increase vigor, and decrease levels of circulating cytokines associated with obesity and inflammation.",2019,"For the self-reported measures, there was a significant increase in vigor/activity (p < 0.001;","['breast cancer survivors', '11 women with a median age of 63 years', 'female breast cancer patients']","['cultural dance program', 'cultural dance intervention']","['vigor/activity', 'circulating biomarker levels', 'weekly moderate exercise', 'physical activity', 'sustainable physical activity', 'quality of life, increase vigor', 'intra-individual body mass index (BMI', 'waist circumference', 'Anthropometric measures, fasting blood draws, and self-reported questionnaires to assess physical activity, mood, and quality of life']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0205695,"For the self-reported measures, there was a significant increase in vigor/activity (p < 0.001;","[{'ForeName': 'Lenora W M', 'Initials': 'LWM', 'LastName': 'Loo', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States. Electronic address: lloo@cc.hawaii.edu.'}, {'ForeName': 'Kryslin', 'Initials': 'K', 'LastName': 'Nishibun', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Welsh', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'TeMoana', 'Initials': 'T', 'LastName': 'Makolo', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Clayton D', 'Initials': 'CD', 'LastName': 'Chong', 'Affiliation': ""The Queen's Medical Center, Queen's Cancer Center, 1301 Punchbowl Street, Honolulu, HI, 96813, United States.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pagano', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}, {'ForeName': 'Erin O', 'Initials': 'EO', 'LastName': 'Bantum', 'Affiliation': 'University of Hawaii Cancer Center, Population Sciences in the Pacific Program, 701 Ilalo Street, Honolulu, HI, 96813, United States.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2019.102197']
228,32272287,Short interval or continuous training programs to improve walking distance for intermittent claudication: Pilot study.,"OBJECTIVE
Supervised exercise training is part of first-line therapies for intermittent claudication. Short periods of intensive treadmill training have been found efficient; however, the optimal modalities remain to be determined, especially interval training with active recovery (ITAR). In this prospective assessor-blinded single-centre pilot study, we assessed the feasibility of a randomised controlled trial comparing parallel 4-week intensive rehabilitation programs comprising treadmill training performed as ITAR or conventional training with constant slope and speed interspersed with rest periods (CT).
METHODS
A total of 38 in- or out-patients were randomised to the ITAR or CT program for 5 days/week for 4weeks. The primary outcome was change in maximum walking distance measured on a graded treadmill before and after the program.
RESULTS
Adherence was high. All training sessions were completed in the ITAR program and only a few were not completed in the CT program (median 100% [Q1-Q3 96-100]). Tolerance was excellent (no adverse events). VO 2peak was low in both groups, corresponding to moderate to severe exercise intolerance. The 2 groups did not differ in the primary outcome (median ITAR vs CT 480 [135-715] vs 315m [0-710]; p=0.62) or other walking distances (constant speed and gradient treadmill test). For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test: median 415 [240-650] to 995m [410-1490], with a large effect size (p<10 -4 ).
CONCLUSION
A 4-week intensive rehabilitation program with ITAR or CT for intermittent claudication showed high adherence, was well tolerated, and improved walking distance as much as that reported for longer conventional programs. These findings prompt the design of a larger multicenter randomised controlled trial.
TRIAL REGISTRATION
NCT01734603.",2020,"For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test:",['A total of 38 in- or out-patients'],"['ITAR or conventional training with constant slope and speed interspersed with rest periods (CT', 'intensive treadmill training', 'ITAR or CT program', 'ITAR or CT', 'continuous training programs', 'Supervised exercise training']","['tolerated, and improved walking distance', 'walking distance', 'walking distances (constant speed and gradient treadmill test', 'VO 2peak', 'maximum walking distance', 'Tolerance']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.0964511,"For all 38 participants, both programs greatly increased maximum walking distance in the graded treadmill test:","[{'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Villemur', 'Affiliation': 'Department of Vascular Rehabilitation, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Thoreau', 'Affiliation': 'Department of Vascular Rehabilitation, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Guinot', 'Affiliation': 'Sports Medicine Department, Grenoble Alpes University Hospital, 38433 Grenoble, France; INSERM U1042, Laboratory HP2, Grenoble Alpes University Hospital, 38000 Grenoble, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Gailledrat', 'Affiliation': 'Sports Medicine Department, Grenoble Alpes University Hospital, 38433 Grenoble, France; Department of Physical and Rehabilitation Medicine, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Evra', 'Affiliation': 'Department of Vascular Rehabilitation, Grenoble Alpes University Hospital, 38433 Grenoble, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Vermorel', 'Affiliation': 'INSERM CIC-1406 Grenoble Alpes University Hospital, 38043 Grenoble, France.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Foote', 'Affiliation': 'Research Division, Grenoble Alpes University Hospital, 38433 Grenoble, France. Electronic address: AFoote@chu-grenoble.fr.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Carpentier', 'Affiliation': 'Vascular Medicine Department, Grenoble Alpes University Hospital, 38433 Grenoble, France; Faculty of Medicine, University Grenoble Alpes, 38000 Grenoble, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC-IMAG, University Grenoble Alpes, 38000 Grenoble, France.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Pérennou', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Grenoble Alpes University Hospital, 38433 Grenoble, France; Lab. Cognitive Neurosciences, CNRS UMR5105, Université Grenoble Alpes, 38040 Grenoble, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.004']
229,32166395,Unilateral transversus abdominis plane block and port-site infiltration : Comparison of postoperative analgesic efficacy in laparoscopic cholecystectomy.,"PURPOSE
To compare the analgesic efficacy of unilateral subcostal transversus abdominis plane (TAP) block with local anesthetic infiltration, applied to the port site in patients undergoing laparoscopic cholecystectomy (LC).
METHODS
Group T received a unilateral subcostal TAP block, group I received a local anesthetic infiltration at port sites, and group C was the control group. Groups T and I received 20 mL 0.25% bupivacaine. Intravenous patient-controlled analgesia with tramadol was similarly applied to all groups. Postoperative pain levels during rest and cough were evaluated using a numeric rating scale (NRS). Nausea and vomiting were evaluated using postoperative nausea vomiting scores (PONV) at 1, 3, 6, 12 and 24 h and tramadol consumption was also determined. Patient satisfaction was evaluated using a Likert-type scale.
RESULTS
Postoperative resting NRS scores were lower in group T than the other groups at 1 h and 12 h (p = 0.007 and p = 0.016), while NRS values during cough were statistically significant at 1 h (p = 0.004). The 24‑h tramadol consumption was different: group T 229 ± 33 mg, group I 335 ± 95 mg, and group C 358 ± 66 mg (p < 0.001). The percentages of patients reporting that they would prefer the applied postoperative pain control method again were 83.3%, 62.5% and 70.8% in groups T, I and C, respectively (p = 0.118).
CONCLUSION
Unilateral subcostal TAP block was superior to local anesthetic infiltration at port sites after LC, in terms of low opioid consumption. Unilateral subcostal TAP block is recommended as part of a multimodal analgesic protocol.",2020,"Postoperative resting NRS scores were lower in group T than the other groups at 1 h and 12 h (p = 0.007 and p = 0.016), while NRS values during cough were statistically significant at 1 h (p = 0.004).",['patients undergoing laparoscopic cholecystectomy (LC'],"['Unilateral transversus abdominis plane block and port-site infiltration ', '20\u202fmL 0.25% bupivacaine', 'laparoscopic cholecystectomy', 'tramadol', 'Unilateral subcostal TAP block', 'unilateral subcostal transversus abdominis plane (TAP) block with local anesthetic infiltration', 'unilateral subcostal TAP block, group\xa0I received a local anesthetic infiltration']","['analgesic efficacy', 'postoperative nausea vomiting scores (PONV', 'Postoperative resting NRS scores', 'NRS values during cough', 'numeric rating scale (NRS', 'Patient satisfaction', 'Nausea and vomiting', 'Postoperative pain levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0442184', 'cui_str': 'Subcostal (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0198813', 'cui_str': 'Local anesthesia, by infiltration (procedure)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0251994,"Postoperative resting NRS scores were lower in group T than the other groups at 1 h and 12 h (p = 0.007 and p = 0.016), while NRS values during cough were statistically significant at 1 h (p = 0.004).","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arık', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Altındağ, Ankara, Turkey. emineincearik@yahoo.com.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Akkaya', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ozciftci', 'Affiliation': 'Department of Anesthesiology and Reanimation, TC Ministry of Health Hitit University Erol Olçok Training and Research Hospital, Çorum, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alptekin', 'Affiliation': 'Department of Anesthesiology, Pain Clinic, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ş', 'Initials': 'Ş', 'LastName': 'Balas', 'Affiliation': 'Department of Surgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}]",Der Anaesthesist,['10.1007/s00101-020-00746-1']
230,32272030,Dry Needling Combined With Guideline-Based Physical Therapy Provides No Added Benefit in the Management of Chronic Neck Pain: A Randomized Controlled Trial.,"OBJECTIVE
To determine the added benefit of combining dry needling with a guideline-based physical therapy treatment program consisting of exercise and manual therapy on pain and disability in people with chronic neck pain.
DESIGN
Randomized controlled trial.
METHODS
Participants were randomized to receive either guideline-based physical therapy or guideline-based physical therapy plus dry needling. The primary outcomes, measured at 1 month post randomization, were average pain intensity in the previous 24 hours and previous week, measured with a numeric pain-rating scale (0-10), and disability, measured with the Neck Disability Index (0-100). The secondary outcomes were pain and disability measured at 3 and 6 months post randomization and global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy measured at 1, 3, and 6 months post randomization.
RESULTS
One hundred sixteen participants were recruited. At 1 month post randomization, people who received guideline-based physical therapy plus dry needling had a small reduction in average pain intensity in the previous 24 hours (mean difference, 1.56 points; 95% confidence interval [CI]: 1.11, 2.36) and in the previous week (mean difference, 1.20 points; 95% CI: 1.02, 2.21). There was no effect of adding dry needling to guideline-based physical therapy on disability at 1 month post randomization (mean difference, -2.08 points; 95% CI: -3.01, 5.07). There was no effect for any of the secondary outcomes.
CONCLUSION
When combined with guideline-based physical therapy for neck pain, dry needling resulted in small improvements in pain only at 1 month post randomization. There was no effect on disability. J Orthop Sports Phys Ther 2020;50(8):447-454. Epub 9 Apr 2020. doi:10.2519/jospt.2020.9389 .",2020,There was no effect of adding dry needling to guideline-based physical therapy on disability at 1-month post-randomization (mean difference: -2.08 points; 95% CI -1.16 to 5.07).,"['Participants', 'people with chronic neck pain', '116 participants were recruited', 'Chronic Neck Pain']","['Guideline-Based Physical Therapy', 'guideline-based physical therapy', 'guideline-based physical therapy or guideline-based physical therapy plus dry needling', 'exercise and manual therapy', 'Combining Dry Needling', 'dry needling plus guideline-based physical therapy']","['numerical pain rating scale (0-10), and disability measured with the Neck Disability Index', 'pain and disability measured at 3 and 6 months, and global perceived effect, quality of sleep, pain catastrophizing, and self-efficacy', 'average pain intensity', 'disability', 'pain', 'pain and disability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",116.0,0.188397,There was no effect of adding dry needling to guideline-based physical therapy on disability at 1-month post-randomization (mean difference: -2.08 points; 95% CI -1.16 to 5.07).,"[{'ForeName': 'Fábio Franciscatto', 'Initials': 'FF', 'LastName': 'Stieven', 'Affiliation': ''}, {'ForeName': 'Giovanni Esteves', 'Initials': 'GE', 'LastName': 'Ferreira', 'Affiliation': ''}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Wiebusch', 'Affiliation': ''}, {'ForeName': 'Francisco Xavier', 'Initials': 'FX', 'LastName': 'de Araújo', 'Affiliation': ''}, {'ForeName': 'Luis Henrique Telles', 'Initials': 'LHT', 'LastName': 'da Rosa', 'Affiliation': ''}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9389']
231,31276804,Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial.,"BACKGROUND
Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care.
METHODS
Participants were randomized to the transition intervention (4 months long, focused on heart-transplant knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models.
RESULTS
Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups.
CONCLUSIONS
The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.",2019,There were no between group and within group differences in percent of tacrolimus bioassays within target range (>50%).,"['Young adult heart transplant (HT) recipients transferring to adult care', 'young adults who underwent HT as children and transferred to adult care', 'Pediatric Heart Transplantation', 'Participants']","['Transitioning to Adult Care (TRANSIT', 'transition intervention (4 months long, focused on HT knowledge, self-care, self-advocacy, and social support) or usual care', 'transition intervention']","['average patient standard deviation of mean tacrolimus levels', 'tacrolimus bioassays', 'Average overall adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}]","[{'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0037438'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005507', 'cui_str': 'Biologic Assays'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.062108,There were no between group and within group differences in percent of tacrolimus bioassays within target range (>50%).,"[{'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Grady', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: kgrady@nm.org.'}, {'ForeName': 'Adin-Cristian', 'Initials': 'AC', 'LastName': 'Andrei', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Shankel', 'Affiliation': ""Department of Medicine, Loma Linda University Children's Hospital, Loma Linda, CA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Chinnock', 'Affiliation': ""Department of Medicine, Loma Linda University Children's Hospital, Loma Linda, CA.""}, {'ForeName': 'Shelley D', 'Initials': 'SD', 'LastName': 'Miyamoto', 'Affiliation': ""Department of Medicine, Children's Hospital Colorado, Aurora, CO.""}, {'ForeName': 'Amrut V', 'Initials': 'AV', 'LastName': 'Ambardekar', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Addonizio', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Farhana', 'Initials': 'F', 'LastName': 'Latif', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Lefkowitz', 'Affiliation': ""Department of Psychiatry, The Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Lee R', 'Initials': 'LR', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Hollander', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pham', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': ""Van't Hof"", 'Affiliation': ""Department of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Weissberg-Benchell', 'Affiliation': ""Department of Psychiatry, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}, {'ForeName': 'Clyde', 'Initials': 'C', 'LastName': 'Yancy', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Menghan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Melody', 'Affiliation': 'Pharmacy Department, Northwestern Memorial Hospital, Chicago, IL.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Department of Medicine, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL.""}]",Journal of cardiac failure,['10.1016/j.cardfail.2019.06.011']
232,32273244,Sleep Improvement Effect on Sexual Life Quality Among Rotating Female Shift Workers: A Randomized Controlled Trial.,"BACKGROUND
Poor sleep quality consequences among shift working nurses are well recognized.
AIM
To investigate the impact of sleep improvement on sexual quality of life.
METHODS
The study was a parallel randomized controlled trial, conducted among 120 female nurses in 2 educational hospitals in the Northeast of Iran, Shahroud. Using random blocks of four, 120 eligible participants were randomly assigned to study groups. Data collecting tools included a demographic data questionnaire, Pittsburgh Sleep Quality Index to assess sleep quality, and the survey of sexual quality of life-female and Sexual Self-Efficacy Questionnaire to evaluate level of sexual quality of life and sexual self-efficacy, respectively. The intervention consisted of 3 weekly sleep intervention sessions that lasted from 90 to 120 minutes.
OUTCOMES
The study's primary and secondary outcomes were sleep quality, and the level of sexual self-efficacy and sexual quality of life, respectively.
RESULTS
By 3-month follow-up, the loss to follow-up rate was 5.9%. The mean sleep quality score was 7.61 ± 2.26 in the recruited participants. Following the intervention, the sleep quality score showed statistically significant differences compared to the control group [mean difference (CI 99.98%), -1.89 (-2.40, -1.38)]. Participants in the intervention group showed modest increases in both measures; sexual self-efficacy [mean difference (CI 99.98%), 8.82 (6.83, 10.81)] and sexual quality of life [mean difference (CI 99.98%), 19.64 (18.08, 21.20)].
CLINICAL IMPLICATIONS
These findings suggest that sleep improvement could promote the sexual quality of life among shift working nurses.
STRENGTHS & LIMITATIONS
Strengths of this study include the use of a validated outcome measure. Focusing the study on female nurses and the small size of the study population are the limitations.
CONCLUSION
Improved sleep showed an impact on sexual quality of life among rotating female shift workers. Khastar H, Mirrezaie SM, Chashmi NA, et al. Sleep Improvement Effect on Sexual Life Quality Among Rotating Female Shift Workers: A Randomized Controlled Trial. J Sex Med 2020;17:1467-1475.",2020,"Following the intervention, the sleep quality score showed statistically significant differences compared to the control group [mean difference (CI 99.98%), -1.89","['Rotating Female Shift Workers', '120 eligible participants', '120 female nurses in 2 educational hospitals in the Northeast of Iran, Shahroud']",[],"['sleep quality, and the level of sexual self-efficacy and sexual quality of life, respectively', 'measures; sexual self-efficacy', 'demographic data questionnaire, Pittsburgh Sleep Quality Index to assess sleep quality, and the survey of sexual quality of life-female and Sexual Self-Efficacy Questionnaire to evaluate level of sexual quality of life and sexual self-efficacy', 'sexual quality of life', 'sleep quality score', 'Sexual Life Quality', 'mean sleep quality score']","[{'cui': 'C0231458', 'cui_str': 'Rotated'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]",[],"[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.107333,"Following the intervention, the sleep quality score showed statistically significant differences compared to the control group [mean difference (CI 99.98%), -1.89","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khastar', 'Affiliation': 'School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Mirrezaie', 'Affiliation': 'Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: mirrezaie@shmu.ac.ir.'}, {'ForeName': 'Nooshin Ahmadian', 'Initials': 'NA', 'LastName': 'Chashmi', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran; Department of Psychology, Shahroud Branch, Islamic Azad University, Shahroud, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Jahanfar', 'Affiliation': 'Assistant Professor, MPH Program, Health Science Program, Central Michigan University, Mount Pleasant, MI, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.03.003']
233,32189446,Simulation in Urological Training and Education (SIMULATE): Protocol and curriculum development of the first multicentre international randomized controlled trial assessing the transferability of simulation-based surgical training.,"OBJECTIVES
To report the study protocol for the first international multicentre randomized controlled trial investigating the effectiveness of simulation-based surgical training and the development process for an evidence-based training curriculum, to be delivered as an educational intervention.
PARTICIPANTS AND METHODS
This prospective, international, multicentre randomized controlled clinical and educational trial will recruit urology surgical trainees who must not have performed ≥10 of the selected index procedure, ureterorenoscopy (URS). Participants will be randomized to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally. The primary outcome is the number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skills (OSATS) assessment scale, for three consecutive operations, without any complications. All participants will be followed up either until they complete 25 procedures or for 18 months. Development of the URS SBT curriculum took place through a two-round Delphi process.
RESULTS
A total of 47 respondents, consisting of trainees (n = 24) with URS experience and urolithiasis specialists (n = 23), participated in round 1 of the Delphi process. Specialists (n = 10) finalized the content of the curriculum in round 2. The developed interventional curriculum consists of initial theoretic knowledge through didactic lectures followed by select tasks and cases on the URO-Mentor (Simbionix, Lod, Israel) VR Simulator, Uro-Scopic Trainer (Limbs & Things, Bristol, UK) and Scope Trainer (Mediskills, Manchester, UK) models for both semi-rigid and flexible URS. Respondents also selected relevant non-technical skills scenarios and cadaveric simulation tasks as additional components, with delivery subject to local availability.
CONCLUSIONS
SIMULATE is the first multicentre trial investigating the effect and transferability of supplementary SBT on operating performance and patient outcomes. An evidence-based training curriculum is presented, developed with expert and trainee input. Participants will be followed and the primary outcome, number of procedures required to proficiency, will be reported alongside key clinical secondary outcomes, (ISCRTN 12260261).",2020,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","['47 respondents consisting of trainees (n=24), with URS experience, and urolithiasis specialists (n=23) participated in round-1 of the Delphi process', 'Surgery', 'urology surgical trainees who must not have performed ≥ 10 of the selected index procedure, ureterorenoscopy (URS']","['Transferability of Simulation-based Training', 'simulation-based surgical training', 'simulation-based training (SBT) or non-simulation-based training (NSBT']","['number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skill (OSATS) assessment scale, on 3 consecutive operations, without any complications']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0451641', 'cui_str': 'Urinary Lithiasis'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1270970', 'cui_str': 'Ureterorenoscopy (procedure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.182342,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","[{'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Aydin', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""School of Cancer and Pharmaceutical Studies, King's College London, London, UK.""}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, UK.'}, {'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJU international,['10.1111/bju.15056']
234,31700147,The effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury: an exploratory study.,"STUDY DESIGN
Experimental before-after design.
OBJECTIVES
The objectives of this study were to explore the effects of local cooling rates on perfusion of sacral skin under externally applied pressure in people with spinal cord injury (SCI).
SETTING
Research laboratory.
METHODS
Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls. Each participant underwent seven protocols, including pressure (60 mmHg) with local cooling (∆t = -10 °C) for 20 min at three cooling rates (-0.5, -4, -10 °C/min), pressure with local cooling for 40 min, pressure with local heating (∆t = +10 °C), local cooling without pressure, and pressure without temperature changes. Each protocol included a 10-min baseline, a 20-min (or 40-min) loading period and a 20-min recovery. A compound sensor head consisting of laser Doppler and heating and cooling probes was used to measure sacral skin blood flow and temperature in the prone position. Blood flow responses were characterized by peak blood flow, recovery time, and total blood flow in the recovery period.
RESULTS
The results demonstrated that the cooling rate at -10 °C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min. There was a significant difference in the recovery time between the 20-min cooling compared with the 40-min cooling for the SCI group (p < 0.05).
CONCLUSIONS
Our findings provide initial evidence that local cooling rates affect skin blood flow responses under externally applied pressure in people with SCI.",2020,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"['people with spinal cord injury', 'people with spinal cord injury (SCI', 'people with SCI', 'Seventeen participants, including seven wheelchair users with SCI and ten able-bodied (AB) controls']","['laser Doppler and heating and cooling probes', 'local cooling rates']","['peak blood flow, recovery time, and total blood flow', 'cooling rate at -10', 'smaller skin blood flow response', 'cooling rate', 'sacral skin blood flow and temperature', 'recovery time', 'Blood flow responses']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0853966', 'cui_str': 'Wheelchair user'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler (procedure)'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}]",17.0,0.0858534,C/min resulted in smaller skin blood flow response compared with -0.5 °C/min (p < 0.05) but were not significantly different to the cooling rate at -4 °C/min.,"[{'ForeName': 'Yih-Kuen', 'Initials': 'YK', 'LastName': 'Jan', 'Affiliation': 'Rehabilitation Engineering Lab, Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Champaign, IL, USA. yjan@illinois.edu.'}]",Spinal cord,['10.1038/s41393-019-0378-x']
235,31710340,"Reactions to Multiple Ascending Doses of the Microtubule Stabilizer TPI-287 in Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome: A Randomized Clinical Trial.","Importance
Basket-design clinical trials that allow investigation of treatment effects on different clinical syndromes that share the same molecular pathophysiology have not previously been attempted in neurodegenerative disease.
Objective
To assess the safety, tolerability, and pharmacodynamics of the microtubule stabilizer TPI-287 (abeotaxane) in Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS).
Design, Setting, and Participants
Two parallel-design, double-blind, placebo-controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham. A total of 94 patients with clinically diagnosed AD (n = 39) and 4RT (n = 55) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria. A total of 29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled. Data were analyzed from December 20, 2013, through May 4, 2017, based on modified intention to treat.
Interventions
Randomization was 8:3 drug to placebo in 3 sequential dose cohorts receiving 2.0, 6.3, or 20.0 mg/m2 of intravenous TPI-287 once every 3 weeks for 9 weeks, with an optional 6-week open-label extension.
Main Outcomes and Measures
Primary end points were safety and tolerability (maximal tolerated dose) of TPI-287. Secondary and exploratory end points included TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures.
Results
A total of 68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT (16 women [38%]; median age, 69 [range, 54-83] years). Three severe anaphylactoid reactions occurred in TPI-287-treated patients with AD, whereas none were seen in patients with 4RT, leading to a maximal tolerated dose of 6.3 mg/m2 for AD and 20.0 mg/m2 for 4RT. More falls (3 in the placebo group vs 11 in the TPI-287 group) and a dose-related worsening of dementia symptoms (mean [SD] in the CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures], 0.5 [1.8] in the placebo group vs 0.7 [1.6] in the TPI-287 group; median difference, 1.5 [95% CI, 0-2.5]; P = .03) were seen in patients with 4RT. Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 [26.0] ng/mL) compared with placebo (mean [SD], 10.4 [42.3] ng/mL; median difference, -14.6 [95% CI, -30.0 to 0.2] ng/mL; P = .048, Mann-Whitney test).
Conclusions and Relevance
In this randomized clinical trial, TPI-287 was less tolerated in patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions. The ability to reveal different tau therapeutic effects in various tauopathy syndromes suggests that basket trials are a valuable approach to tau therapeutic early clinical development.
Trial Registration
ClinicalTrials.gov identifiers: NCT019666666 and NCT02133846.",2020,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","['29 patients with AD, 14 with PSP, and 30 with β-amyloid-negative CBS (determined on positron emission tomography findings) were enrolled', '94 patients with clinically diagnosed AD (n\u2009=\u200939) and 4RT (n\u2009=\u200955) were screened; of these, 3 refused to participate, and 10 with AD and 11 with 4RT did not meet inclusion criteria', '16 women [38%]; median age, 69 [range, 54-83] years', 'patients with AD than in those with 4RT owing to the presence of anaphylactoid reactions', 'Patients With Alzheimer Disease, Progressive Supranuclear Palsy, and Corticobasal Syndrome', 'Alzheimer disease (AD) or the 4-repeat tauopathies (4RT) progressive supranuclear palsy (PSP) and corticobasal syndrome (CBS', 'controlled phase 1 randomized clinical trials in AD and 4RT were conducted from December 20, 2013, through May 4, 2017, at the University of California, San Francisco, and University of Alabama at Birmingham', '68 participants (38 men [56%]; median age, 65 [range, 50-85] years) were included in the modified intention-to-treat analysis, of whom 26 had AD (14 women [54%]; median age, 63 [range, 50-76] years), and 42 had 4RT']","['microtubule stabilizer TPI-287 (abeotaxane', 'placebo', 'Microtubule Stabilizer TPI-287', 'TPI-287']","['safety and tolerability (maximal tolerated dose) of TPI-287', 'CDR plus NACC FTLD-SB [Clinical Dementia Rating scale sum of boxes with frontotemporal dementia measures', 'severe anaphylactoid reactions', 'TPI-287 levels in cerebrospinal fluid (CSF) and changes on biomarker, clinical, and neuropsychology measures', 'worsening of dementia symptoms', 'safety, tolerability, and pharmacodynamics', 'chitinase-3-like protein-1 (YKL-40) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0038868', 'cui_str': 'Steele-Richardson-Olszewski Disease'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0949664', 'cui_str': 'Tauopathies'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0026046', 'cui_str': 'Microtubules'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C1710314', 'cui_str': 'TPI-287'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0751072', 'cui_str': 'FTLD'}, {'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal Lobe Dementia (FLDEM)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0340865', 'cui_str': 'Anaphylactoid reaction (disorder)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007807'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027903', 'cui_str': 'Neuropsychologies'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3872855', 'cui_str': 'GP-39 Protein'}]",68.0,0.508308,"Despite undetectable TPI-287 levels in CSF, CSF biomarkers demonstrated decreased chitinase-3-like protein-1 (YKL-40) levels in the 4RT treatment arm (mean [SD], -8.4 ","[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Tsai', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Koestler', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Rojas', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ljubenkov', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Howard J', 'Initials': 'HJ', 'LastName': 'Rosen', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Gil D', 'Initials': 'GD', 'LastName': 'Rabinovici', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'Department of Neurology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Cobigo', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Brown', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Joo In', 'Initials': 'JI', 'LastName': 'Jung', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hare', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Geldmacher', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Natelson-Love', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'McKinley', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Luong', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Emmeline L', 'Initials': 'EL', 'LastName': 'Chuu', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Powers', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Paige', 'Initials': 'P', 'LastName': 'Mumford', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Merhdad', 'Initials': 'M', 'LastName': 'Shamloo', 'Affiliation': 'Wu Tsai Neurosciences Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Miller', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Roberson', 'Affiliation': ""Alzheimer's Disease Center, Department of Neurology, University of Alabama at Birmingham.""}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Boxer', 'Affiliation': 'Memory and Aging Center, Department of Neurology, Sandler Neurosciences Center, University of California, San Francisco.'}]",JAMA neurology,['10.1001/jamaneurol.2019.3812']
236,32246106,Effect of High Intensity Interval Training on Matrix Metalloproteinases in Women with Breast Cancer Receiving Anthracycline-Based Chemotherapy.,"Anthracycline chemotherapy is commonly used to treat breast cancer yet may increase the level of matrix metalloproteinases (MMP) -2 and -9, which increase the risk of atherosclerosis. While exercise has been shown to reduce the level of MMP in patients with diabetes, high intensity interval training (HIIT) has not been utilized to improve level of MMP in women with breast cancer receiving anthracycline chemotherapy. Thirty women were randomized to either 8-week HIIT or control (CON) group. The CON group was offered the HIIT intervention after 8 weeks. MMP-1, -2 -7, -9, tissue inhibitor of MMP (TIMP) -1, and-2 were measured at baseline and post-intervention. Repeated measures ANCOVA and paired t-test were performed to assess changes in MMP and TIMP. Post-intervention, no significant between-group differences were observed for MMP and TIMP. However, within-group decrease in MMP-9 was observed in the HIIT group [104.3(51.9) to 65.2(69.1); P = 0.01]. MMP-9 in the CON group was not significantly changed [115.5(47.2) to 90.4(67.9);]. MMP-2 significantly increased in both the HIIT group [76.6(11.2) to 83.2(13.1); P = 0.007) and the CON group [69.0(8.9) to 77.6(11.1) P = 0.003). It is unclear whether an 8-week HIIT intervention influences MMP-9 in breast cancer patients undergoing anthracycline chemotherapy. Additional investigations are required to understand the exercise-induced changes in MMP-2 and -9 in women undergoing anthracycline chemotherapy.",2020,MMP-2 significantly increased in both the HIIT group [76.6(11.2) to 83.2(13.1); P = 0.007) and the CON group [69.0(8.9) to 77.6(11.1) P = 0.003).,"['patients with diabetes', 'women with breast cancer receiving', 'women undergoing anthracycline chemotherapy', 'Women with Breast Cancer', 'breast cancer patients undergoing anthracycline chemotherapy', 'Thirty women']","['Anthracycline chemotherapy', '8-week HIIT or control (CON', 'High Intensity Interval Training', 'HIIT intervention', 'CON', 'Anthracycline-Based Chemotherapy', 'anthracycline chemotherapy']","['9, tissue inhibitor of MMP (TIMP', 'MMP and TIMP', 'changes in MMP and TIMP', 'MMP-2', 'Matrix Metalloproteinases', 'MMP-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0145988', 'cui_str': 'TIMP Proteins'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0172537', 'cui_str': 'Gelatinase A'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}]",30.0,0.0254776,MMP-2 significantly increased in both the HIIT group [76.6(11.2) to 83.2(13.1); P = 0.007) and the CON group [69.0(8.9) to 77.6(11.1) P = 0.003).,"[{'ForeName': 'Kyuwan', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': ""Division of Cardiology, Children's Hospital Los Angeles, Keck School of Medicine, University of Southern California (USC), Los Angeles, CA, 90089, USA.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kang', 'Affiliation': 'Department of Medicine, Keck School of Medicine, USC, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, USC, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Mortimer', 'Affiliation': 'Division of Medical Oncology & Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, 91010, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Sattler', 'Affiliation': 'Department of Medicine, Keck School of Medicine, USC, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Salem', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, Ostrow School of Dentistry, USC, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Dieli-Conwright', 'Affiliation': 'Division of Population Sciences, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, 02215, USA. ChristinaM_Dieli-Conwright@DFCI.Harvard.edu.'}]",Scientific reports,['10.1038/s41598-020-61927-x']
237,32112114,Comparison of intubating conditions after induction with propofol and remifentanil or sufentanil : Randomized controlled REMIDENT trial for surgical tooth extraction.,"PURPOSE
The aim of this study was to compare tracheal intubation conditions after induction of anesthesia with a bolus of propofol-sufentanil or propofol-remifentanil and a rapid induction technique.
MATERIAL AND METHODS
A total of 70 patients (American Society of Anesthesiologists (ASA) classification I‑II) undergoing outpatient surgery under general anesthesia with intubation for tooth extraction were randomly assigned to two groups in this double-blind study. Patients received either a bolus of remifentanil (3 μg/kg) or sufentanil (0.3 μg/kg) together with 2.5 mg/kg propofol for intubation. The primary outcome was the percentage of excellent intubation conditions and the secondary outcomes were the percentage of patients with a decrease of over 20% in mean arterial pressure (MAP) or heart rate (HR), time to achieve spontaneous respiration, time between the end of surgery and extubation and time to achieve an Aldrete score of 10. VAS pain score was >3 or having laryngeal pain 15 min after arriving in the postanesthesia care unit (PACU) were also analyzed.
RESULTS
Intubating conditions (perfect + good conditions) were significantly better with remifentanil than with sufentanil (88.5% vs. 68.6%; p = 0.01). When using remifentanil, the hemodynamic conditions were good. Using remifentanil did not significantly increase the pain score or the laryngeal pain in the recovery room. This was confirmed by no significant differences between the groups for morphine consumption. Remifentanil significantly decreased the time to achieve an Aldrete score of 10.
CONCLUSION
When intubation without muscle relaxants is required, intubating conditions are much better when a remifentanil bolus is used compared to a sufentanil bolus. The remifentanil/propofol rapid induction technique is a valuable technique to quickly intubate and achieve good conditions.",2020,"RESULTS
Intubating conditions (perfect + good conditions) were significantly better with remifentanil than with sufentanil (88.5% vs. 68.6%; p = 0.01).",['70\xa0patients (American Society of Anesthesiologists (ASA) classification I‑II) undergoing outpatient surgery under general anesthesia with intubation for tooth extraction'],"['Remifentanil', 'propofol and remifentanil', 'propofol', 'sufentanil ', 'remifentanil/propofol', 'remifentanil', 'sufentanil', 'propofol-sufentanil or propofol-remifentanil']","['mean arterial pressure (MAP) or heart rate (HR), time to achieve\xa0spontaneous respiration, time between the end of surgery and extubation and time to achieve an Aldrete score of\xa010', 'pain score or the laryngeal pain', 'VAS pain score', 'percentage of excellent intubation conditions', 'time to achieve an Aldrete score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040440', 'cui_str': 'Tooth Extraction'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration (finding)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0549373', 'cui_str': 'Laryngeal pain'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",,0.236305,"RESULTS
Intubating conditions (perfect + good conditions) were significantly better with remifentanil than with sufentanil (88.5% vs. 68.6%; p = 0.01).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dolsan', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bruneteau', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roche', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ferré', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Labaste', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sommet', 'Affiliation': 'Laboratory of Medical and Clinical Pharmacology, Pharmacoepidemiology, Inserm U1027, Toulouse University, Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Conil', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Minville', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Toulouse University Hospital, Avenue Jean Poulhès, 31432, Toulouse, France. minville.v@chu-toulouse.fr.'}]",Der Anaesthesist,['10.1007/s00101-020-00739-0']
238,31767947,Clinical recommendations for use of lidocaine lubricant during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia: results from a randomised clinical trial.,"STUDY DESIGN
Clinical trial.
OBJECTIVE
Spinal cord injury (SCI) impacts autonomic function and bowel management. Bowel care is a potential trigger for autonomic dysreflexia (AD; paroxysmal hypertension elicited by sensory stimuli below the level of lesion). AD can be life threatening so strategies to minimise AD are prioritised after SCI. Lidocaine lubricant is recommended during bowel care with the rationale to minimise the sensory stimulus, reducing AD. The objective of this study was to assess whether lidocaine lubricant (Xylocaine 2%) ameliorates AD during at-home bowel care compared with standard lubricant (placebo).
SETTING
Community.
METHOD
Participants (n = 13; age 44.0 ± 3.3 years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring. Injury to spinal autonomic (sympathetic) nerves was determined from low-frequency systolic arterial pressure (LF SAP) variability.
RESULTS
Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control. Bowel care duration was increased with lidocaine (79.1 ± 10.0 min) compared to placebo (57.7 ± 6.3 min; p = 0.018). All participants experienced AD on both days, but maximum SAP was higher with lidocaine (214.3 ± 10.5 mmHg) than placebo (196.7 ± 10.0 mmHg; p = 0.046). Overall, SAP was higher for longer with lidocaine (6.5 × 10 5 ± 0.9 × 10 5 mmHg • beat) than placebo (4.4 × 10 5 ± 0.6 × 10 5 mmHg • beat; p = 0.018) indicating a higher burden of AD. Heart rate and rhythm disturbances were increased during AD, particularly with lidocaine use.
CONCLUSIONS
At-home bowel care was a potent trigger for AD. Our findings contradict recommendations for lidocaine use during bowel care, suggesting that anaesthetic lubricants impair reflex bowel emptying, resulting in longer care routines with an increased burden of AD.",2020,"RESULTS
Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","['Participants (n\u2009=\u200913; age 44.0\u2009±\u20093.3\xa0years) with high-level SCI (C3-T4) performed their normal at-home bowel care on two days, each time using a different lubricant, with continuous non-invasive cardiovascular monitoring', 'during bowel care after spinal cord injury prolong care routines and worsen autonomic dysreflexia', 'Community']","['lidocaine', 'standard lubricant (placebo', 'placebo', 'lidocaine lubricant', 'lidocaine lubricant (Xylocaine 2%) ameliorates AD', 'Lidocaine lubricant']","['autonomic function', 'Overall, SAP', 'maximum SAP', 'Heart rate and rhythm disturbances', 'Bowel care duration', 'low-frequency systolic arterial pressure (LF SAP) variability']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0161959', 'cui_str': 'Cardiovascular monitoring (regime/therapy)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0238015', 'cui_str': 'Spinal Autonomic Dysreflexia'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282222', 'cui_str': 'Lubrication Agents'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0150155', 'cui_str': 'Bowel management'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.186011,"RESULTS
Participants displayed reduced autonomic function (LF SAP 3.02 ± 0.84 mmHg 2 ), suggesting impaired autonomic control.","[{'ForeName': 'Vera-Ellen M', 'Initials': 'VM', 'LastName': 'Lucci', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Maureen S', 'Initials': 'MS', 'LastName': 'McGrath', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Inskip', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Shirromi', 'Initials': 'S', 'LastName': 'Sarveswaran', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Willms', 'Affiliation': 'International Collaboration on Repair and Discoveries (ICORD), University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Claydon', 'Affiliation': 'Department of Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada. victoria_claydon@sfu.ca.'}]",Spinal cord,['10.1038/s41393-019-0381-2']
239,31996581,Minimal Open Hemorrhoidectomy Versus Transanal Hemorrhoidal Dearterialization: The Effect on Symptoms: An Open-Label Randomized Controlled Trial.,"BACKGROUND
There is limited evidence on the long-term efficacy of transanal hemorrhoidal dearterialization compared with hemorrhoidectomy. Most studies investigated short-term effects with postoperative pain as the primary outcome. Being a benign disease, the long-term goal of treatment for hemorrhoids is the resolution of symptoms and improvement of quality of life.
OBJECTIVE
The purpose of this study was to compare the effect of minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization on patient-reported symptoms.
DESIGN
This was an open-label randomized controlled trial.
SETTINGS
This was a single-center study.
PATIENTS
Patients with symptomatic hemorrhoids grade II to IV (Goligher's classification) were included.
INTERVENTIONS
Patients were randomly allocated to minimal open hemorrhoidectomy or transanal hemorrhoidal dearterialization.
MAIN OUTCOME MEASURES
The primary outcome was symptoms assessed by the Hemorrhoidal Disease Symptom Score 1 year postoperatively. Secondary outcomes included health-related quality of life, patient satisfaction, postoperative pain and recovery, adverse events, recurrence, and hospital costs.
RESULTS
Forty-eight patients received minimal open hemorrhoidectomy, and 50 patients received transanal hemorrhoidal dearterialization. No difference in symptom score at 1-year follow-up was found. Median (range) symptom score was 3 (0-17) after minimal open hemorrhoidectomy and 5 (0-17) after transanal hemorrhoidal dearterialization (median difference = -1.0 (95% CI, -3.0 to 0.0); p = 0.15). Residual hemorrhoidal prolapse was reported more frequently (p = 0.008), and more patients had treatment for recurrence after transanal hemorrhoidal dearterialization (7 vs 0 patients; p = 0.013). Patient satisfaction was higher after minimal open hemorrhoidectomy (p = 0.049). No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p > 0.05). Transanal hemorrhoidal dearterialization was more expensive (median difference = &OV0556;555 (95% CI, &OV0556;472-&OV0556;693); p < 0.001).
LIMITATIONS
No blinding was included in this study.
CONCLUSION
No difference was found in symptom score 1 year postoperatively. Minimal open hemorrhoidectomy had a better effect on the hemorrhoidal prolapse and higher patient satisfaction. More patients needed treatment for recurrence after transanal hemorrhoidal dearterialization. Minimal open hemorrhoidectomy has an immediate postoperative course similar to transanal hemorrhoidal dearterialization. See Video Abstract at http://links.lww.com/DCR/B152.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02061176. HEMORROIDECTOMíA MíNIMA ABIERTA VERSUS DESARTERIALIZACIóN HEMORROIDAL TRANSANAL: EL EFECTO SOBRE LOS SíNTOMAS: UN ESTUDIO ABIERTO CONTROLADO Y ALEATORIZADO: Hay evidencia limitada sobre la eficacia a largo plazo de la desarterialización hemorroidal transanal en comparación con la hemorroidectomía. La mayoría de los estudios han investigado los efectos a corto plazo con el dolor postoperatorio como el resultado primario. Al ser una enfermedad benigna, el objetivo a largo plazo del tratamiento de la enfermedad hemorroidal es la resolución de los síntomas y la mejora en la calidad de vida.Comparar el efecto de la hemorroidectomía abierta mínima versus la desarterialización hemorroidal transanal en los síntomas reportados por el paciente.Ensayo controlado aleatorizado abierto.Estudio en sede única.Pacientes con enfermedad hemorroidal sintomática de grado II-IV (clasificación de Goligher).Los pacientes fueron asignados aleatoriamente a hemorroidectomía mínima abierta o desarterialización hemorroidal transanal.El resultado primario fueron los síntomas evaluados por el Score de Síntomas de Enfermedad Hemorroidal un año después de la operación. Los resultados secundarios incluyeron calidad de vida relacionada con la salud, satisfacción del paciente, dolor y recuperación postoperatorios, eventos adversos, recurrencia y costos hospitalarios.Cuarenta y ocho pacientes recibieron hemorroidectomía abierta mínima y cincuenta pacientes recibieron desarterialización hemorroidal transanal. No se encontraron diferencias en la puntuación de los síntomas al año de seguimiento. La puntuación mediana (rango) de síntomas fue 3 (0-17) después de una hemorroidectomía mínima abierta y 5 (0-17) después de la desarterialización hemorroidal transanal (diferencia mediana [IC95%]: -1.0 [-3.0-0.0], p = 0.15). El prolapso hemorroidal residual se informó con mayor frecuencia (p = 0.008) y más pacientes recibieron tratamiento por recurrencia después de la desarterialización hemorroidal transanal (7 frente a 0 pacientes, p = 0.013). La satisfacción del paciente fue mayor después de una hemorroidectomía abierta mínima (p = 0.049). No se encontraron diferencias en el impacto sobre la calidad de vida relacionada con la salud, el dolor postoperatorio promedio y máximo, la recuperación o los eventos adversos (p> 0.05). La desarterialización hemorroidal transanal fue más costosa (diferencia mediana [IC95%]: &OV0556; 555 [472-693], p <0.001).Estudio sin cegamiento.No se encontraron diferencias en la puntuación de los síntomas a un año después de la operación. La hemorroidectomía mínima abierta tuvo un mejor efecto sobre el prolapso hemorroidal y una mayor satisfacción del paciente. Más pacientes necesitaron tratamiento para la recurrencia después de la desarterialización hemorroidal transanal. La hemorroidectomía abierta mínima tiene un curso postoperatorio inmediato similar a la desarterialización hemorroidal transanal. Consulte Video Resumen en http://links.lww.com/DCR/B152. (Traducción-Dr. Jorge Silva Velazco).ClinicalTrials.gov Identifier: NCT02061176.",2020,"No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p>0.05).","[""Patients with symptomatic hemorrhoids grade II-IV (Goligher's classification"", 'Single-center study']","['minimal open hemorrhoidectomy', 'hemorrhoidectomy', 'Transanal Hemorrhoidal Dearterialization', 'Transanal hemorrhoidal dearterialization', 'transanal hemorrhoidal dearterialization', 'minimal open hemorrhoidectomy versus transanal hemorrhoidal dearterialization', 'Minimal Open Hemorrhoidectomy', 'minimal open hemorrhoidectomy or transanal hemorrhoidal dearterialization']","['health-related quality of life, average and peak postoperative pain, recovery, or adverse events', 'symptom score', 'Hemorrhoidal Disease Symptom Score one year postoperatively', 'Residual hemorrhoidal prolapse', 'Patient satisfaction', 'Median (range) symptom score', 'hemorrhoidal prolapse and higher patient satisfaction', 'health-related quality of life, patient satisfaction, postoperative pain and recovery, adverse events, recurrence and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0019112', 'cui_str': 'Hemorrhoids'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0473074', 'cui_str': 'Open hemorrhoidectomy (procedure)'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0589371', 'cui_str': 'Transanal approach (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0743887,"No differences were found in the impact on health-related quality of life, average and peak postoperative pain, recovery, or adverse events (p>0.05).","[{'ForeName': 'Håvard D', 'Initials': 'HD', 'LastName': 'Rørvik', 'Affiliation': ''}, {'ForeName': 'André H', 'Initials': 'AH', 'LastName': 'Campos', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Styr', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ilum', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Grant K', 'Initials': 'GK', 'LastName': 'McKinstry', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Brandstrup', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Olaison', 'Affiliation': 'Department of Surgery, Holbaek Hospital, Holbaek, Denmark.'}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001588']
240,31942669,A randomised controlled study of high intensity exercise as a dishabituating stimulus to improve hypoglycaemia awareness in people with type 1 diabetes: a proof-of-concept study.,"AIMS/HYPOTHESIS
Approximately 25% of people with type 1 diabetes have suppressed counterregulatory hormonal and symptomatic responses to insulin-induced hypoglycaemia, which renders them at increased risk of severe, disabling hypoglycaemia. This is called impaired awareness of hypoglycaemia (IAH), the cause of which is unknown. We recently proposed that IAH develops through habituation, a form of adaptive memory to preceding hypoglycaemia. Consistent with this hypothesis, we demonstrated restoration of defective counterregulatory hormonal responses to hypoglycaemia (referred to as dishabituation) in a rodent model of IAH following introduction of a novel stress stimulus (high intensity training [HIT]). In this proof-of-concept study we sought to further test this hypothesis by examining whether a single episode of HIT would amplify counterregulatory responses to subsequent hypoglycaemia in people with type 1 diabetes who had IAH (assessed by Gold score ≥4, modified Clarke score ≥4 or Dose Adjustment For Normal Eating (DAFNE) hypoglycaemia awareness rating 2 or 3). The primary outcome was the difference in adrenaline response to hypoglycaemia following both a single episode of HIT and rest.
METHODS
In this randomised, crossover study 12 participants aged between 18 and 55 years with type 1 diabetes for ≥5 years and an HbA 1c <75 mmol/mol (9%) were recruited. Individuals were randomised using computer generated block randomisation to start with one episode of HIT (4 × 30 s cycle sprints [2 min recovery] at 150% of maximum wattage achieved during [Formula: see text] assessment) or rest (control). The following day they underwent a 90 min hyperinsulinaemic-hypoglycaemic clamp study at 2.5 mmol/l with measurement of hormonal counterregulatory response, symptom scores and cognitive testing (four-choice reaction time and digit symbol substitution test). Each intervention and subsequent clamp study was separated by at least 2 weeks. The participants and investigators were not blinded to the intervention or measurements during the study. The investigators were blinded to the primary outcome and blood analysis results.
RESULTS
All participants (six male and six female, age 19-54 years, median [IQR] duration of type 1 diabetes 24.5 [17.3-29.0] years, mean [SEM] HbA 1c 56 [3.67] mmol/mol; 7.3% [0.34%]) completed the study (both interventions and two clamps). In comparison with the rest study, a single episode of HIT led to a 29% increase in the adrenaline (epinephrine) response (mean [SEM]) (2286.5 [343.1] vs 2953.8 [384.9] pmol/l); a significant increase in total symptom scores (Edinburgh Hypoglycaemia Symptom Scale: 24.25 [2.960 vs 27.5 [3.9]; p<0.05), and a significant prolongation of four-choice reaction time (591.8 [22.5] vs 659.9 [39.86] ms; p<0.01] during equivalent hypoglycaemia induced the following day.
CONCLUSIONS/INTERPRETATION
These findings are consistent with the hypothesis that IAH develops in people with type 1 diabetes as a habituated response and that introduction of a novel stressor can restore, at least partially, the adapted counterregulatory hormonal, symptomatic and cognitive responses to hypoglycaemia.
TRIAL REGISTRATION
ISRCTN15236211.",2020,"In comparison with the rest study, a single episode of HIT led to a 29% increase in the adrenaline (epinephrine) response (mean [SEM]) (2286.5 [343.1] vs 2953.8 [384.9] pmol/l); a significant increase in total symptom scores (Edinburgh Hypoglycaemia Symptom Scale: 24.25 [2.960 vs 27.5 [3.9]; p<0.05), and a significant prolongation of four-choice reaction time (591.8 [22.5] vs 659.9 [39.86] ms; p<0.01] during equivalent hypoglycaemia induced the following day.
","['30', 'Approximately 25% of people with type', 'people with type', '12 participants aged between 18 and 55\xa0years with type 1 diabetes for ≥5\xa0years and an HbA 1c \xa0<75\xa0mmol/mol (9%) were recruited', 'people with type 1 diabetes who had IAH', 'All participants (six male and six female, age 19-54\xa0years, median [IQR] duration of type 1 diabetes 24.5 [17.3-29.0] years, mean [SEM] HbA 1c 56 [3.67] mmol/mol; 7.3% [0.34%]) completed the study (both interventions and two clamps']",['high intensity exercise'],"['prolongation of four-choice reaction time', 'total symptom scores (Edinburgh Hypoglycaemia Symptom Scale', 'hypoglycaemia awareness', 'Gold score\u2009≥4, modified Clarke score\u2009≥4 or Dose Adjustment For Normal Eating (DAFNE) hypoglycaemia awareness rating 2 or 3', 'cycle sprints [2\xa0min recovery', 'adrenaline response to hypoglycaemia', 'adrenaline (epinephrine) response']","[{'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0222045'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",12.0,0.183153,"In comparison with the rest study, a single episode of HIT led to a 29% increase in the adrenaline (epinephrine) response (mean [SEM]) (2286.5 [343.1] vs 2953.8 [384.9] pmol/l); a significant increase in total symptom scores (Edinburgh Hypoglycaemia Symptom Scale: 24.25 [2.960 vs 27.5 [3.9]; p<0.05), and a significant prolongation of four-choice reaction time (591.8 [22.5] vs 659.9 [39.86] ms; p<0.01] during equivalent hypoglycaemia induced the following day.
","[{'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'Farrell', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, DD19SY, UK.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'McNeilly', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, DD19SY, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fournier', 'Affiliation': 'Faculty of Science, School of Human Science, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Jones', 'Affiliation': 'Faculty of Health and Medical Sciences, Paediatrics, The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Simona M', 'Initials': 'SM', 'LastName': 'Hapca', 'Affiliation': 'Computing Science and Mathematics, Faculty of Natural Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'West', 'Affiliation': 'Institute of Cellular Medicine, Faculty of Medical Science, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Rory J', 'Initials': 'RJ', 'LastName': 'McCrimmon', 'Affiliation': 'Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, DD19SY, UK. r.mccrimmon@dundee.ac.uk.'}]",Diabetologia,['10.1007/s00125-019-05076-5']
241,31950229,How conclusive is the CONCLUDE trial?,"The development of basal insulin analogues has reduced the risk of hypoglycaemia in insulin-treated individuals with type 2 diabetes. Insulin degludec and insulin glargine 300 U/ml (glargine U300) represent an evolution of basal insulin analogues, both of them reducing the risk of hypoglycaemia as compared with that associated with glargine U100. However, whether degludec and glargine U300 are equivalent with respect to glycaemic control and risk of hypoglycaemia remains to be fully ascertained. In the CONCLUDE trial, 1609 individuals with type 2 diabetes were randomised to either degludec 200 U/ml (degludec U200) or glargine U300. In this issue of Diabetologia (https://doi.org/10.1007/s00125-019-05080-9) the investigators report that during the maintenance period, HbA 1c improved to a similar extent in the two groups with no significant difference in the rate of overall hypoglycaemia (the primary endpoint of the study), while rates of nocturnal symptomatic and severe hypoglycaemia (secondary endpoints) were lower with degludec U200 than with glargine U300. These results, although of great interest to the clinician, need to be carefully interpreted as they cannot be considered as conclusive. First, the primary endpoint was not met and, therefore, analyses of secondary endpoints remain exploratory. Even assuming that degludec is superior to glargine in reducing the risk of hypoglycaemia, the mechanism(s) accounting for such an advantage remain elusive and potential differences in pharmacokinetics and pharmacodynamics difficult to appreciate because of methodological issues. The study design had to be amended because of lack of reliability of the glucometers initially used in the trial, particularly in the low blood glucose ranges, so the potential implications of these changes in the subsequent conduct of the trial cannot be excluded. Finally, comparison with the BRIGHT trial, the only other available head-to-head study, is complicated by differences between the two studies in the primary endpoint (HbA 1c reduction vs reduction of the risk of hypoglycaemia), study population (insulin-experienced vs insulin-naive) and concomitant glucose-lowering medications. In spite of all this, CONCLUDE teaches us an important lesson regarding the need, particularly in the clinical setting, to monitor the reliability of the glucometers the diabetic individual uses to adjust his/her insulin dose. Insufficient precision or inappropriate use of the glucometer can easily offset any minute advantage a new insulin can offer with respect to glycaemic control and risk of hypoglycaemia.",2020,"However, whether degludec and glargine U300 are equivalent with respect to glycaemic control and risk of hypoglycaemia remains to be fully ascertained.",['1609 individuals with type 2 diabetes'],"['glargine', 'Insulin degludec and insulin glargine 300', 'glargine U300']","['risk of hypoglycaemia), study population (insulin-experienced vs insulin-naive) and concomitant glucose-lowering medications', 'risk of hypoglycaemia', 'rates of nocturnal symptomatic and severe hypoglycaemia', 'rate of overall hypoglycaemia']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1609.0,0.0453593,"However, whether degludec and glargine U300 are equivalent with respect to glycaemic control and risk of hypoglycaemia remains to be fully ascertained.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical & Experimental Medicine, Section of Diabetes, University of Pisa, Nuovo Ospedale Santa Chiara, Via Paradisa, 2, 56124, Pisa, Italy. stefano.delprato@med.unipi.it.'}]",Diabetologia,['10.1007/s00125-020-05086-8']
242,31960071,"Vascular improvements in individuals with type 2 diabetes following a 1 year randomised controlled exercise intervention, irrespective of changes in cardiorespiratory fitness.","AIMS/HYPOTHESIS
Vascular changes in individuals with type 2 diabetes mellitus majorly contribute to the development of cardiovascular disease. Increased cardiorespiratory fitness (CRF) has been associated with improvements in vascular health. Although CRF tends to improve with exercise training, there remains a portion of participants with little or no improvement. Given the importance of vascular function in individuals with type 2 diabetes, we assessed whether individuals who failed to improve CRF following a 1 year exercise intervention also failed to improve arterial stiffness and structural indices.
METHODS
Individuals with type 2 diabetes with no major micro- and macrovascular complications and aged between 30 and 75 years old (n = 63) participated in a three-arm, 1 year, randomised controlled exercise intervention in Lisbon, Portugal. The study involved a non-exercise control group, a moderate continuous training combined with resistance training (RT) group and a high-intensity interval training with RT group. Allocation of participants into the intervention and control groups was done using a computer-generated list of random numbers. An improvement in CRF was defined as a change in [Formula: see text] ≥5%. Vascular stiffness and structural indices were measured using ultrasound imaging and applanation tonometry. Generalised estimating equations were used to compare changes in vascular measures across individuals in the control group (n = 22) and those in the exercise groups who either had improved CRF (CRF responders; n = 14) or whose CRF did not improve (CRF non-responders; n = 27) following 1 year of exercise training.
RESULTS
Compared with the control group, exercisers, with and without improvements in CRF, had decreased carotid intima-media thickness (IMT) (CRF responders: β = -2.84 [95% CI -5.63, -0.04]; CRF non-responders: β = -5.89 [95% CI -9.38, -2.40]) and lower-limb pulse wave velocity (PWV) (CRF responders: β = -0.14 [95% CI -0.25, -0.03]; CRF non-responders: β = -0.14 [95% CI -0.25, -0.03]), the latter being an indicator of peripheral arterial stiffness. Only CRF responders had decreased PWV of the upper limb compared with control participants (β = -0.12 [95% CI -0.23, -0.01]). As for central stiffness, CRF non-responders had increased aortic PWV compared with CRF responders (β = 0.19 [95% CI 0.07, 0.31]), whereas only the CRF non-responders had altered carotid distensibility coefficient compared with the control group (β = 0.00 [95% CI 3.01 × 10 -5 , 0.00]). No interaction effects between the CRF responders and non-responders vs control group were found for the remaining stiffness or haemodynamic indices (p>0.05).
CONCLUSIONS/INTERPRETATION
Regardless of improvements in CRF, individuals with type 2 diabetes had significant improvements in carotid IMT and lower-limb arterial stiffness following a 1 year exercise intervention. Thus, a lack of improvement in CRF following exercise in people with type 2 diabetes does not necessarily entail a lack of improvement in vascular health.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03144505 FUNDING: This work was supported by fellowships from the Portuguese Foundation for Science and Technology. This work is also financed by a national grant through the Fundação para a Ciência e Tecnologia (FCT), within the unit I&D 472.",2020,"No interaction effects between the CRF responders and non-responders vs control group were found for the remaining stiffness or haemodynamic indices (p>0.05).
","['individuals with type 2 diabetes following a 1\xa0year randomised', 'people with type 2 diabetes', 'CRF non-responders', 'individuals with type 2 diabetes mellitus', 'Individuals with type 2 diabetes with no major micro- and macrovascular complications and aged between 30 and 75\xa0years old (n\u2009=\u200963) participated in a three-arm, 1\xa0year, randomised', 'individuals with type 2 diabetes']","['moderate continuous training combined with resistance training (RT) group and a high-intensity interval training with RT group', 'controlled exercise intervention', 'controlled exercise intervention in Lisbon, Portugal']","['carotid intima-media thickness (IMT', 'carotid IMT and lower-limb arterial stiffness', 'PWV of the upper limb', 'lower-limb pulse wave velocity (PWV) (CRF responders', 'carotid distensibility coefficient', 'Increased cardiorespiratory fitness (CRF', 'arterial stiffness and structural indices', 'aortic PWV', 'CRF', 'Vascular stiffness and structural indices', 'Vascular improvements']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0032729', 'cui_str': 'Portuguese Republic'}]","[{'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",,0.0867885,"No interaction effects between the CRF responders and non-responders vs control group were found for the remaining stiffness or haemodynamic indices (p>0.05).
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hetherington-Rauth', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Magalhães', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Pedro B', 'Initials': 'PB', 'LastName': 'Júdice', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Melo', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'Exercise and Health Laboratory, CIPER, Faculdade de Motricidade Humana, Universidade de Lisboa, Estrada da Costa, 1499-002, Cruz-Quebrada, Portugal. lsardinha@fmh.ulisboa.pt.'}]",Diabetologia,['10.1007/s00125-020-05089-5']
243,32172039,Manipulating sleep duration perception changes cognitive performance - An exploratory analysis.,"OBJECTIVES
To test the effect of perceived sleep duration on cognitive performance.
METHODS
Sixteen healthy individuals [8F; mean age (± SD): 24.2 ± 3.0 years)] received an 8-h sleep opportunity followed by a 5-h opportunity on two consecutive nights. Upon waking, they were randomized to being informed that they received either an 8-h or 5-h sleep opportunity, via a clock that ran either fast, slow or normally. Cognitive performance was assessed using 10-min auditory psychomotor vigilance tests and subjective sleepiness ratings. Homeostatic and circadian sleep drive was assessed using waking electroencephalography (EEG).
RESULTS
Reaction time was significantly quicker when individuals thought that they had slept for 8 h but given a 5-h sleep opportunity. Conversely, reaction times were significantly slower when individuals thought they had 5 h of sleep but given an 8-h sleep opportunity. EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity. EEG delta power did not increase, however, with perceived sleep restriction. EEG high-alpha activity (10.5-11.5 Hz) was consistently higher when participants thought that they had an 8-h sleep opportunity, regardless of the actual duration.
CONCLUSIONS
These results suggest that perceived sleep duration may modulate psychosomatic responses. Additional studies with predefined outcomes and analyses are necessary to confirm these findings, which may have important implications for understanding how sleep affects cognition and psychosomatic responses.",2020,"EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity.",['Sixteen healthy individuals [8F; mean age (± SD): 24.2\xa0±\xa03.0\xa0years'],[],"['Homeostatic and circadian sleep drive', 'EEG high-alpha activity', 'reaction times', 'Cognitive performance', '10-min auditory psychomotor vigilance tests and subjective sleepiness ratings', 'EEG delta power', 'Reaction time']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.0585712,"EEG delta power (1.0-4.5 Hz) during wake increased significantly when sleep was restricted to 5 h, and individuals thought they slept for 5 h, but this increase was attenuated with a perceived sleep duration of 8 h following a 5-h opportunity.","[{'ForeName': 'Shadab A', 'Initials': 'SA', 'LastName': 'Rahman', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA 02115, United States of America; Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America. Electronic address: sarahman@rics.bwh.harvard.edu.""}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Rood', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Trent', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Solet', 'Affiliation': 'Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America; Department of Medicine, Cambridge Health Alliance, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Langer', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, MA 02139, United States of America.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': ""Division of Sleep and Circadian Disorders, Departments of Medicine and Neurology, Brigham and Women's Hospital, Boston, MA 02115, United States of America; Division of Sleep Medicine, Harvard Medical School, Boston, MA 02115, United States of America.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.109992']
244,31840813,Intensive vs Standard Blood Pressure Control in Adults 80 Years or Older: A Secondary Analysis of the Systolic Blood Pressure Intervention Trial.,"OBJECTIVES
To evaluate the effect of intensive systolic blood pressure (SBP) control in older adults with hypertension, considering cognitive and physical function.
DESIGN
Secondary analysis.
SETTING
Systolic Blood Pressure Intervention Trial (SPRINT) PARTICIPANTS: Adults 80 years or older.
INTERVENTION
Participants with hypertension but without diabetes (N = 1167) were randomized to an SBP target below 120 mm Hg (intensive treatment) vs a target below 140 mm Hg (standard treatment).
MEASUREMENTS
We measured the incidence of cardiovascular disease (CVD), mortality, changes in renal function, mild cognitive impairment (MCI), probable dementia, and serious adverse events. Gait speed was assessed via a 4-m walk test, and the Montreal Cognitive Assessment (MoCA) was used to quantify baseline cognitive function.
RESULTS
Intensive treatment led to significant reductions in cardiovascular events (hazard ratio [HR] = .66; 95% confidence interval [CI] = .49-.90), mortality (HR = .67; 95% CI = .48-.93), and MCI (HR = .70; 95% CI = .51-.96). There was a significant interaction (P < .001) whereby participants with higher baseline scores on the MoCA derived strong benefit from intensive treatment for a composite of CVD and mortality (HR = .40; 95% CI = .28-.57), with no appreciable benefit in participants with lower scores on the MoCA (HR = 1.33 = 95% CI = .87-2.03). There was no evidence of heterogeneity of treatment effects with respect to gait speed. Rates of acute kidney injury and declines of at least 30% in estimated glomerular filtration rate were increased in the intensive treatment group with no between-group differences in the rate of injurious falls.
CONCLUSION
In adults aged 80 years or older, intensive SBP control lowers the risk of major cardiovascular events, MCI, and death, with increased risk of changes to kidney function. The cardiovascular and mortality benefits of intensive SBP control may not extend to older adults with lower baseline cognitive function.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT01206062. J Am Geriatr Soc 68:496-504, 2020.",2020,"Rates of acute kidney injury and declines of at least 30% in estimated glomerular filtration rate were increased in the intensive treatment group with no between-group differences in the rate of injurious falls.
","['older adults with lower baseline cognitive function', 'adults aged 80\u2009years or older', ' Adults 80\u2009years or older', 'Participants with hypertension but without diabetes (N = 1167', 'older adults with hypertension, considering cognitive and physical function', 'Adults 80\u2009Years or Older']","['SBP target below 120\u2009mm Hg (intensive treatment) vs a target below 140\u2009mm Hg (standard treatment', 'intensive SBP control', 'intensive systolic blood pressure (SBP) control', 'Intensive vs Standard Blood Pressure Control']","['Gait speed', 'glomerular filtration rate', 'risk of major cardiovascular events, MCI, and death', 'mortality', 'Montreal Cognitive Assessment (MoCA', 'cardiovascular events', 'incidence of cardiovascular disease (CVD), mortality, changes in renal function, mild cognitive impairment (MCI), probable dementia, and serious adverse events', 'rate of injurious falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3496286'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",1167.0,0.430574,"Rates of acute kidney injury and declines of at least 30% in estimated glomerular filtration rate were increased in the intensive treatment group with no between-group differences in the rate of injurious falls.
","[{'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford Veterans Affairs Hospital, Bedford, Massachusetts.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Bress', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Callahan', 'Affiliation': 'Section of Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Larry J', 'Initials': 'LJ', 'LastName': 'Fine', 'Affiliation': 'Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Section on Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Mahboob', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Department of Medicine, Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Rocco', 'Affiliation': 'Section of Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Joni K', 'Initials': 'JK', 'LastName': 'Snyder', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Still', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': 'Division of Geriatrics, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Virginia G', 'Initials': 'VG', 'LastName': 'Wadley', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Section of Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16272']
245,31984443,"Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial.","AIMS/HYPOTHESIS
A head-to-head randomised trial was conducted to evaluate hypoglycaemia safety with insulin degludec 200 U/ml (degludec U200) and insulin glargine 300 U/ml (glargine U300) in individuals with type 2 diabetes treated with basal insulin.
METHODS
This randomised (1:1), open-label, treat-to-target, multinational trial included individuals with type 2 diabetes, aged ≥18 years with HbA 1c ≤80 mmol/mol (9.5%) and BMI ≤45 kg/m 2 . Participants were previously treated with basal insulin with or without oral glucose-lowering drugs (excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk. Both degludec U200 and glargine U300 were similarly titrated to a fasting blood glucose target of 4.0-5.0 mmol/l. Endpoints were assessed during a 36 week maintenance period and a total treatment period up to 88 weeks. There were three hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose [<3.1 mmol/l] with symptoms); (2) nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms, between 00:01 and 05:59 h); and (3) severe hypoglycaemia. The primary endpoint was the number of overall symptomatic hypoglycaemic events in the maintenance period. Secondary hypoglycaemia endpoints included the number of nocturnal symptomatic events and number of severe hypoglycaemic events during the maintenance period.
RESULTS
Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the glargine U300 arm completed the trial (87.3% and 87.8% completed on treatment, respectively). Baseline characteristics were comparable between the two treatment arms. For the primary endpoint, the rate of overall symptomatic hypoglycaemia was not significantly lower with degludec U200 vs glargine U300 (rate ratio [RR] 0.88 [95% CI 0.73, 1.06]). As there was no significant difference between treatments for the primary endpoint, the confirmatory testing procedure for superiority was stopped. The pre-specified confirmatory secondary hypoglycaemia endpoints were analysed using pre-specified statistical models but were now considered exploratory. These endpoints showed a lower rate of nocturnal symptomatic hypoglycaemia (RR 0.63 [95% CI 0.48, 0.84]) and severe hypoglycaemia (RR 0.20 [95% CI 0.07, 0.57]) with degludec U200 vs glargine U300.
CONCLUSIONS/INTERPRETATION
There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period. The rates of nocturnal symptomatic and severe hypoglycaemia were nominally significantly lower with degludec U200 during the maintenance period compared with glargine U300.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03078478 FUNDING: This trial was funded by Novo Nordisk (Bagsvaerd, Denmark).",2020,There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period.,"['individuals with type 2 diabetes treated with basal insulin', 'excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk', 'insulin-treated patients with type 2 diabetes', 'individuals with type 2 diabetes, aged ≥18\xa0years with HbA 1c ≤80\xa0mmol/mol (9.5%) and BMI ≤45\xa0kg/m 2 ', 'Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the']","['basal insulin with or without oral glucose-lowering drugs', 'insulin degludec versus insulin glargine U300', 'glargine', 'insulin degludec 200\xa0U/ml (degludec U200) and insulin glargine 300\xa0U/ml (glargine U300']","['nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms', 'number of overall symptomatic hypoglycaemic events', 'fasting blood glucose', 'severe hypoglycaemia', 'hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose', 'hypoglycaemia safety', 'Risk of hypoglycaemia', 'rates of nocturnal symptomatic and severe hypoglycaemia', 'rate of overall symptomatic hypoglycaemia', 'rate of nocturnal symptomatic hypoglycaemia', 'number of nocturnal symptomatic events and number of severe hypoglycaemic events']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4704833', 'cui_str': 'Secretagogues'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1609.0,0.398525,There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period.,"[{'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, 10140 Campus Point Drive, Suite 200, San Diego, CA, 92121, USA. Philis-Tsimikas.Athena@scrippshealth.org.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Klonoff', 'Affiliation': 'Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes and Endocrinology, Brampton, ON, Canada.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, Division of Endocrinology & Metabolism, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lone N', 'Initials': 'LN', 'LastName': 'Troelsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Ladelund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Endocrinology and Metabolism, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-019-05080-9']
246,30929028,Positive effects of acupressure bands combined with relaxation music/instructions on patients most at risk for chemotherapy-induced nausea.,"PURPOSE
Research by our group has shown that acupressure bands are efficacious in reducing chemotherapy-induced nausea (CIN) for breast cancer patients who expect nausea, and that their effectiveness in controlling CIN can largely be accounted for by patients' expectations of efficacy, i.e., a placebo effect. The present research examined if the effectiveness of acupressure bands could be enhanced by boosting patients' expectation of the bands' efficacy.
METHODS
Two hundred forty-two chemotherapy-naïve patients with breast cancer who expected nausea were randomized. Arms 1 and 2 received acupressure bands, plus a relaxation MP3 and written handout that were either expectancy-enhancing (arm 1) or expectancy-neutral (arm 2). Arm 3 was the control without bands or MP3 and received standard care. All participants received guideline-specified antiemetics.
RESULTS
Peak CIN for arms 1, 2, and 3 on a 1-7 scale was 3.52, 3.55, and 3.87, respectively (p = 0.46). Because no differences were observed between arms 1 and 2 (primary analysis), we combined these two arms (intervention) and compared them to controls for the following analyses. A significant interaction was found between intervention/control and receiving doxorubicin-based chemotherapy (yes/no) and pre-treatment anxiety (high/low). Intervention patients receiving doxorubicin had lower peak CIN than controls (3.62 vs. 4.38; p = 0.02). Similarly, intervention patients with high pre-treatment anxiety had a lower peak CIN than controls (3.62 vs. 4.62; p = 0.01).
CONCLUSIONS
In breast cancer patients undergoing chemotherapy and having high CIN expectation, acupressure bands combined with a relaxation recording were effective in reducing CIN for patients who received doxorubicin or had high anxiety.",2019,Intervention patients receiving doxorubicin had lower peak CIN than controls (3.62 vs. 4.38; p = 0.02).,"['breast cancer patients undergoing', 'breast cancer patients', 'patients most at risk for chemotherapy-induced nausea', 'Two hundred forty-two chemotherapy-naïve patients with breast cancer who expected nausea were randomized']","['acupressure bands, plus a relaxation MP3 and written handout that were either expectancy-enhancing (arm 1) or expectancy-neutral (arm 2', 'chemotherapy', 'doxorubicin', 'acupressure bands combined with relaxation music/instructions', 'doxorubicin-based chemotherapy', 'control without bands or MP3 and received standard care']",['lower peak CIN'],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",242.0,0.0416074,Intervention patients receiving doxorubicin had lower peak CIN than controls (3.62 vs. 4.38; p = 0.02).,"[{'ForeName': 'Anita R', 'Initials': 'AR', 'LastName': 'Peoples', 'Affiliation': 'Department of Population Health Sciences, Huntsman Cancer Institute, University of Utah, 2000 Circle of Hope Drive, Salt Lake City, UT, 84112, USA. anita.peoples@hci.utah.edu.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Shayne', 'Affiliation': 'Department of Medicine, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, NY, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Kirshner', 'Affiliation': 'Hematology-Oncology Associates of Central New York, East Syracuse, NY, USA.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Bushunow', 'Affiliation': 'Rochester Regional Health, Rochester, NY, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Roscoe', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center, Rochester, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04736-x']
247,32215583,Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer.,"Importance
In men with recurrent prostate cancer, addition of long-term antiandrogen therapy to salvage radiotherapy (SRT) was associated with overall survival (OS) in the NRG/RTOG 9601 study. However, hormone therapy has associated morbidity, and there are no validated predictive biomarkers to identify which patients derive most benefit from treatment.
Objective
To examine the role of pre-SRT prostate-specific antigen (PSA) levels to personalize hormone therapy use with SRT.
Interventions
Men were randomized to SRT plus high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d) or placebo for 2 years.
Design, Setting, and Participants
In this secondary analysis of the multicenter RTOG 9601 double-blind, placebo-controlled randomized clinical trial conducted from 1998 to 2003 by a multinational cooperative group, men with a positive surgical margin or pathologic T3 disease after radical prostatectomy with pre-SRT PSA of 0.2 to 4.0 ng/mL were included. Analysis was performed between March 4, 2019, and December 20, 2019.
Main Outcomes and Measures
The primary outcome was overall survival (OS). Secondary end points included distant metastasis (DM), other-cause mortality (OCM), and grades 3 to 5 cardiac and neurologic toxic effects. Subgroup analyses were performed using the protocol-specified PSA stratification variable (1.5 ng/mL) and additional PSA cut points, including test for interaction. Competing risk analyses were performed for DM and other-cause mortality (OCM).
Results
Overall, 760 men with PSA elevation after radical prostatectomy for prostate cancer were included. The median (range) age of particpants was 65 (40-83) years. Antiandrogen assignment was associated with an OS benefit in the PSA stratum greater than 1.5 ng/mL (n = 118) with a 25% 12-year absolute benefit (hazard ratio [HR], 0.45; 95% CI, 0.25-0.81), but not in the PSA of 1.5 ng/mL or less stratum (n = 642) (1% 12-year absolute difference; HR, 0.87; 95% CI, 0.66-1.16). In a subanalysis of men with PSA of 0.61 to 1.5 (n = 253), there was an OS benefit associated with antiandrogen assignment (HR, 0.61; 95% CI, 0.39-0.94). In those receiving early SRT (PSA ≤0.6 ng/mL, n = 389), there was no improvement in OS (HR, 1.16; 95% CI, 0.79-1.70), an increased OCM hazard (subdistribution HR, 1.94; 95% CI, 1.17-3.20; P = .01), and an increased odds of late grades 3 to 5 cardiac and neurologic toxic effects (odds ratio, 3.57; 95% CI, 1.09-15.97; P = .05).
Conclusions and Relevance
These results suggest that pre-SRT PSA level may be a prognostic biomarker for outcomes of antiandrogen treatment with SRT. In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes. In men receiving early SRT (PSA ≤0.6 ng/mL), long-term antiandrogen treatment was not associated with improved OS. Future randomized clinical trials are needed to determine hormonal therapy benefit in this population.
Trial Registration
ClinicalTrials.gov Identifier: NCT00002874.",2020,"In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes.","['Interventions\n\n\nMen', 'Men With Prostate Cancer', '760 men with PSA elevation after radical prostatectomy for prostate cancer', 'men with recurrent prostate cancer, addition of long-term', '1998 to 2003 by a multinational cooperative group, men with a positive surgical margin or pathologic T3 disease after radical prostatectomy with pre-SRT PSA of 0.2 to 4.0 ng/mL were included']","['SRT plus high-dose nonsteroidal antiandrogen (bicalutamide, 150 mg/d) or placebo', 'Long-term Antiandrogen Therapy', 'antiandrogen therapy to salvage radiotherapy (SRT', 'placebo']","['OS benefit', 'Presalvage Radiotherapy PSA Levels', 'distant metastasis (DM), other-cause mortality (OCM), and grades 3 to 5 cardiac and neurologic toxic effects', 'overall survival (OS', 'OCM hazard', 'neurologic toxic effects', 'OS', 'improved OS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1320169', 'cui_str': 'AntiAndrogens, Nonsteroidal'}, {'cui': 'C0285590', 'cui_str': 'bicalutamide'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",760.0,0.618209,"In patients receiving late SRT (PSA >0.6 ng/mL, hormone therapy was associated with improved outcomes.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Dess', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Yilun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Jackson', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Jairath', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Amar U', 'Initials': 'AU', 'LastName': 'Kishan', 'Affiliation': 'Department of Radiation Oncology, University of California, Los Angeles.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Wallington', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Mahal', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Stish', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Zachery S', 'Initials': 'ZS', 'LastName': 'Zumsteg', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, West Hollywood, California.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Den', 'Affiliation': 'Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Hall', 'Affiliation': 'Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'Laila A', 'Initials': 'LA', 'LastName': 'Gharzai', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaworski', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Zachary R', 'Initials': 'ZR', 'LastName': 'Reichert', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Morgan', 'Affiliation': 'Department of Urology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Department of Pathology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Sartor', 'Affiliation': 'Department of Medicine, Tulane Cancer Center, New Orleans, Louisiana.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Radiation Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William Robert', 'Initials': 'WR', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Duke Health, Durham, North Carolina.'}, {'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Radiation Oncology, Sutter Medical Group, Sacramento, California.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Michalski', 'Affiliation': 'Department of Radiation Oncology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Schipper', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Dignam', 'Affiliation': 'Department of Public Health Sciences, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Pisansky', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Zietman', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': 'Department of Radiation Oncology, Cedars-Sinai Medical Center, West Hollywood, California.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Felix Y', 'Initials': 'FY', 'LastName': 'Feng', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Spratt', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0109']
248,31858186,"An exploratory, randomised, placebo-controlled, 14 day trial of the soluble guanylate cyclase stimulator praliciguat in participants with type 2 diabetes and hypertension.","AIMS/HYPOTHESIS
Praliciguat (IW-1973), a soluble guanylate cyclase stimulator, amplifies nitric oxide signalling. This exploratory trial investigated the safety, tolerability, pharmacokinetic profile and pharmacodynamic effects of praliciguat in individuals with type 2 diabetes and hypertension.
METHODS
This Phase IIA, double-blind, placebo-controlled trial investigated praliciguat in 26 participants with type 2 diabetes and hypertension on stable glucose- and BP-lowering therapies. Participants were randomly allocated in a 3:5:5 ratio to three groups: placebo (n = 6), praliciguat 40 mg once daily for days 1-14 (n = 10), or praliciguat 20 mg twice daily for days 1-7 then 40 mg once daily for days 8-14 (n = 10). Assessments were made in clinic and included treatment-emergent adverse events, pharmacokinetics, metabolic variables, 24 h BP and heart rate, platelet function, reactive hyperaemia index (RHI) and plasma biomarkers. Participants, the sponsor, the investigator and clinic study staff (except designated pharmacy personnel) were blinded to group assignment.
RESULTS
Participants treated for 14 days with praliciguat had least-square mean change-from-baseline differences vs placebo (95% CI) of -0.7 (-1.8, 0.4) mmol/l for fasting plasma glucose, -0.7 (-1.1, -0.2) mmol/l for total cholesterol, -0.5 (-1.0, -0.1) mmol/l for LDL-cholesterol, -23 (-56, 9) for HOMA-IR in those not being treated with insulin, and -5 (-10, 1) mmHg and 3 (-1, 6) beats/min for average 24 h mean arterial pressure and heart rate, respectively. Apart from one serious adverse event (SAE; upper gastrointestinal haemorrhage), praliciguat was well tolerated. Praliciguat did not affect platelet function or RHI. Among exploratory biomarkers, plasma levels of asymmetric dimethylarginine decreased in praliciguat vs placebo recipients.
CONCLUSIONS/INTERPRETATION
In participants with type 2 diabetes and hypertension on standard therapies, over 14 days praliciguat was well tolerated, except for a single SAE, and showed positive trends in metabolic and BP variables. These results support further clinical investigation of praliciguat.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03091920.
FUNDING
This trial was funded by Cyclerion Therapeutics.",2020,"Apart from one serious adverse event (SAE; upper gastrointestinal haemorrhage), praliciguat was well tolerated.","['participants with type 2 diabetes and hypertension', 'individuals with type 2 diabetes and hypertension', 'Participants, the sponsor, the investigator and clinic study staff (except designated pharmacy personnel', '26 participants with type 2 diabetes and hypertension on stable glucose- and BP-lowering therapies']","['placebo', 'soluble guanylate cyclase stimulator praliciguat']","['fasting plasma glucose', 'plasma levels of asymmetric dimethylarginine', 'safety, tolerability, pharmacokinetic profile and pharmacodynamic effects', 'platelet function or RHI', 'adverse events, pharmacokinetics, metabolic variables, 24\xa0h BP and heart rate, platelet function, reactive hyperaemia index (RHI) and plasma biomarkers', 'mean arterial pressure and heart rate', 'HOMA-IR', 'tolerated']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1097411', 'cui_str': 'Soluble Guanylate Cyclase'}, {'cui': 'C0175727', 'cui_str': 'Stimulator, device (physical object)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0067385', 'cui_str': 'asymmetric dimethylarginine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",26.0,0.58247,"Apart from one serious adverse event (SAE; upper gastrointestinal haemorrhage), praliciguat was well tolerated.","[{'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Hanrahan', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA. JHanrahan@Cyclerion.com.'}, {'ForeName': 'Jelena P', 'Initials': 'JP', 'LastName': 'Seferovic', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Wakefield', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Phebe J', 'Initials': 'PJ', 'LastName': 'Wilson', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Chickering', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Jung', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Carlson', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Zimmer', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Frelinger', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA, USA.""}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, MA, USA.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc., Chula Vista, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Ironwood Pharmaceuticals, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Currie', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'G Todd', 'Initials': 'GT', 'LastName': 'Milne', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Albert T', 'Initials': 'AT', 'LastName': 'Profy', 'Affiliation': 'Cyclerion Therapeutics, Inc., 301 Binney Street, Cambridge, MA, 02142, USA.'}]",Diabetologia,['10.1007/s00125-019-05062-x']
249,30937600,Effects of exercise on inflammation in patients receiving chemotherapy: a nationwide NCORP randomized clinical trial.,"PURPOSE
A growing body of research suggests that inflammation plays a role in many chemotherapy-related toxicities such as fatigue, anxiety, and neuropathy. Regular exercise can change levels of individual cytokines (e.g., reducing IL-6, increasing IL-10); however, it is not known whether exercise during chemotherapy affects relationships between cytokines (i.e., whether cytokine concentrations change collectively vs. independently). This study assessed how 6 weeks of exercise during chemotherapy affected relationships between changes in concentrations of several cytokines.
METHODS
This is a secondary analysis of a randomized trial studying 6 weeks of moderate-intensity walking and resistance exercise during chemotherapy compared with chemotherapy alone. At pre- and post-intervention, patients provided blood to assess serum concentrations of cytokines IL-1β, IL-6, IL-8, IL-10, and IFN-γ, and receptor sTNFR1. We investigated relationships between cytokines using the correlations between changes in cytokine concentrations from pre- to post-intervention.
RESULTS
We obtained complete data from 293 patients (149 randomized to exercise). Exercise strengthened the correlation between concentration changes of IL-10 and IL-6 (r = 0.44 in exercisers vs. 0.11 in controls; p = 0.001). We observed the same pattern for IL-10:IL-1β and IL-10:sTNFR1. Exercise also induced an anti-inflammatory cytokine profile, per reductions in pro-inflammatory IFN-γ (p = 0.044) and perhaps IL-1β (p = 0.099, trend-level significance).
CONCLUSIONS
Our hypothesis-generating work suggests that regular exercise during 6 weeks of chemotherapy may cause certain cytokine concentrations to change collectively (not independently). This work enhances our understanding of relationships between cytokines and complements traditional analyses of cytokines in isolation. Future work should test for replication and relationships to patient outcomes.
TRIAL REGISTRATION
Clinical Trials.gov, # NCT00924651, http://www.clinicaltrials.gov .",2019,"Exercise also induced an anti-inflammatory cytokine profile, per reductions in pro-inflammatory IFN-γ (p = 0.044) and perhaps IL-1β (p = 0.099, trend-level significance).
","['293 patients (149 randomized to exercise', 'patients receiving chemotherapy']","['exercise', 'chemotherapy alone', 'Regular exercise', 'moderate-intensity walking and resistance exercise during chemotherapy']","['serum concentrations of cytokines IL-1β, IL-6, IL-8, IL-10, and IFN-γ, and receptor sTNFR1', 'concentration changes of IL-10 and IL-6', 'IL-6, increasing IL-10', 'perhaps IL-1β', 'anti-inflammatory cytokine profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",293.0,0.382522,"Exercise also induced an anti-inflammatory cytokine profile, per reductions in pro-inflammatory IFN-γ (p = 0.044) and perhaps IL-1β (p = 0.099, trend-level significance).
","[{'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Kleckner', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA. Ian_Kleckner@URMC.Rochester.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kamen', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Cole', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Chunkit', 'Initials': 'C', 'LastName': 'Fung', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Guido', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Adedayo A', 'Initials': 'AA', 'LastName': 'Onitilo', 'Affiliation': 'Wisconsin NCORP, Weston, WI, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Pacific Cancer Research Consortium NCORP, Bethesda, MD, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Kuebler', 'Affiliation': 'Columbus NCORP, Columbus, OH, USA.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Mohile', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Mustian', 'Affiliation': 'James P. Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04772-7']
250,30946478,Can menstrual health apps selected based on users' needs change health-related factors? A double-blind randomized controlled trial.,"OBJECTIVE
Most healthcare providers are reluctant to use health apps for healthcare because there is no rigorous way of choosing the best app for their patient or consumer. Accordingly, we developed a new method of app selection that fully considers target users' needs. This study verified whether health apps selected based on target users' needs can influence health-related factors.
MATERIALS AND METHODS
We conducted a randomized control trial of women with dysmenorrhea and premenstrual syndrome using App A (the best app selected using the new method) and App B (the app with the highest number of users worldwide). The intervention was performed over 4 months to include at least 3 menstrual cycles.
RESULTS
Sixty-one app users completed the 16-week intervention. While users rated both apps as higher in quality than previously used menstrual apps, only App A users showed significant improvements in overall satisfaction, app outcome expectancy, the number of days with records, app social influence, intent to recommend, and the possibility of behavioral or cognitive changes in their symptom management. The number of menus used increased over time. While the app self-efficacy and the number of relief methods did not significantly differ between groups, they still showed an increase in App A users.
CONCLUSIONS
When a menstrual app reflected users' needs, they recorded their symptoms more often and reported higher app quality, satisfaction, and intention to recommend. This study can not only benefit the selection of menstrual apps, but also confirm that mobile health apps can improve health-related factors.",2019,"While the app self-efficacy and the number of relief methods did not significantly differ between groups, they still showed an increase in App A users.
","['Sixty-one app users completed the 16-week intervention', 'women with dysmenorrhea and premenstrual syndrome using App A (the best app selected using the new method) and App B (the app with the highest number of users worldwide']",[],"['number of relief methods', 'number of menus used increased over time', 'overall satisfaction']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",61.0,0.373608,"While the app self-efficacy and the number of relief methods did not significantly differ between groups, they still showed an increase in App A users.
","[{'ForeName': 'Jisan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing science, College of Life & Health Sciences, Hoseo University, Asan, Korea.'}, {'ForeName': 'Jeongeun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Interdisciplinary Program of Medical Informatics, Seoul National University, Seoul, Korea.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz019']
251,32271051,"Math anxiety, but not induced stress, is associated with objective numeracy.","Many daily activities require a basic understanding of math. Numeracy, which refers to individual differences in the ability to understand numerical concepts and work with probabilities, has been linked to health-related decision-making and medical and financial outcomes. Whether affective influences impact numeracy has not been experimentally assessed, although research has shown that emotions impact judgments and decision-making. Stress is one commonly experienced affective influence that could impact numeracy. We examined whether objective and subjective numeracy were influenced by stress induced from anticipating giving a speech in a laboratory setting. We also examined the association of self-reported math anxiety, or apprehension pertaining to mathematics, with objective and subjective numeracy. Two experiments were conducted; the second was a direct replication. Undergraduate students (Experiment 1, n = 99; Experiment 2 , n = 139) were randomly assigned to one of two conditions: a stress induction or a neutral condition. Whereas neither objective nor subjective numeracy significantly differed across conditions, math anxiety was a consistent predictor of objective and subjective numeracy. Math anxiety and baseline perceived stress did not consistently moderate any effects. These findings have implications for health care, educational, and financial contexts in which people must make decisions that involve complex numbers. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Whereas neither objective nor subjective numeracy significantly differed across conditions, math anxiety was a consistent predictor of objective and subjective numeracy.","['Undergraduate students (Experiment 1, n = 99; Experiment 2 , n = 139']",['stress induction or a neutral condition'],"['objective nor subjective numeracy', 'Math anxiety']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C5191072', 'cui_str': '139'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",2.0,0.0190821,"Whereas neither objective nor subjective numeracy significantly differed across conditions, math anxiety was a consistent predictor of objective and subjective numeracy.","[{'ForeName': 'Samantha S', 'Initials': 'SS', 'LastName': 'Choi', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Taber', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Pooja G', 'Initials': 'PG', 'LastName': 'Sidney', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000268']
252,32235852,Kinesiologist-guided functional exercise in addition to intradialytic cycling program in end-stage kidney disease patients: a randomised controlled trial.,"Intradialytic cycling is a widely used workout mode, whereas added benefit of other exercise modalities remains unknown. This is the first randomised controlled trial on the effects and sustainability of functional training and counselling in addition to intradialytic cycling. Patients were randomly assigned to a kinesiologist-guided functional training in addition to intradialytic cycling (n = 20, experimental group) or intradialytic cycling only (n = 20, control group) over 16 weeks. The experimental group attended predialysis functional exercise in the first eight weeks and afterward performed functional training at home for the next eight weeks. The primary study endpoint was 10-repetition-sit-to-stand test time at eight weeks: at this test, the experimental group improved significantly better than controls (-4.5 ± 1.9 s, 95%CI -8.4 to -0.7; P = 0.021), which was maintained at week 16 (-4.7 ± 2.1 s, 95%CI -9.0 to -0.3; P = 0.037). At week 8, the experimental group significantly outperformed controls also at handgrip strength (P = 0.004), lower body flexibility test (P < 0.001), balance test (P < 0.001), and upper body flexibility test (P = 0.003). At week 16, superior results of the experimental group in secondary end-points remained preserved for handgrip strength, balance, and upper body flexibility tests. Functional training with exercise counselling meaningfully improves physical performance and successfully prepares patients for sustainable home exercise.",2020,"At week 8, the experimental group significantly outperformed controls also at handgrip strength (P = 0.004), lower body flexibility test (P < 0.001), balance test (P < 0.001), and upper body flexibility test (P = 0.003).",['end-stage kidney disease patients'],"['predialysis functional exercise', 'functional training and counselling', 'kinesiologist-guided functional training in addition to intradialytic cycling (n\u2009=\u200920, experimental group) or intradialytic cycling', 'Kinesiologist-guided functional exercise', 'Functional training with exercise counselling', 'intradialytic cycling program']","['10-repetition-sit-to-stand test time', 'balance test', 'lower body flexibility test', 'handgrip strength', 'physical performance', 'handgrip strength, balance, and upper body flexibility tests', 'upper body flexibility test']","[{'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}]",,0.0834617,"At week 8, the experimental group significantly outperformed controls also at handgrip strength (P = 0.004), lower body flexibility test (P < 0.001), balance test (P < 0.001), and upper body flexibility test (P = 0.003).","[{'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Pajek', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Jadranka', 'Initials': 'J', 'LastName': 'Buturović Ponikvar', 'Affiliation': 'University Medical Centre, Department of Nephrology, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Vedran', 'Initials': 'V', 'LastName': 'Hadžić', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'University of Ljubljana, Faculty of Sport, Ljubljana, 1000, Slovenia. maja.pajek@fsp.uni-lj.si.'}]",Scientific reports,['10.1038/s41598-020-62709-1']
253,32259297,Comparison of the duration of hospital stay after laparoscopic or open distal pancreatectomy: randomized controlled trial.,"BACKGROUND
Studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss and recovery. Only one randomized study is available, which showed enhanced functional recovery after LDP compared with ODP.
METHODS
Consecutive patients evaluated at a multidisciplinary tumour board and planned for standard distal pancreatectomy were randomized prospectively to LDP or ODP in an unblinded, parallel-group, single-centre superiority trial. The primary outcome was postoperative hospital stay.
RESULTS
Of 105 screened patients, 60 were randomized and 58 (24 women, 41 per cent) were included in the intention-to-treat analysis; there were 29 patients of mean age 68 years in the LDP group and 29 of mean age 63 years in the ODP group. The main indication was cystic pancreatic lesions, followed by neuroendocrine tumours. The median postoperative hospital stay was 5 (i.q.r. 4-5) days in the laparoscopic group versus 6 (5-7) days in the open group (P = 0·002). Functional recovery was attained after a median of 4 (i.q.r. 2-6) versus 6 (4-7) days respectively (P = 0·007), and duration of surgery was 120 min in both groups (P = 0·482). Blood loss was less with laparoscopic surgery: median 50 (i.q.r. 25-150) ml versus 100 (100-300) ml in the open group (P = 0·018). No difference was found in the complication rates (Clavien-Dindo grade III or above: 4 versus 8 patients respectively). The rate of delayed gastric emptying and clinically relevant postoperative pancreatic fistula did not differ between the groups.
CONCLUSION
LDP is associated with shorter hospital stay than ODP, with shorter time to functional recovery and less bleeding. Registration number: ISRCTN26912858 ( www.isrctn.com).",2020,No difference was found in the complication rates (Clavien-Dindo grade III or above: 4 versus 8 patients respectively).,"['Consecutive patients evaluated at a multidisciplinary tumour board and planned for standard distal pancreatectomy', '105 screened patients, 60 were randomized and 58 (24 women, 41 per cent) were included in the intention-to-treat analysis; there were 29 patients of mean age 68\u2009years in the LDP group and 29 of mean age 63\u2009years in the ODP group']","['laparoscopic or open distal pancreatectomy', 'LDP or ODP', 'LDP', 'laparoscopic distal pancreatectomy (LDP']","['functional recovery', 'functional recovery and less bleeding', 'complication rates', 'Blood loss', 'duration of surgery', 'median postoperative hospital stay', 'postoperative hospital stay', 'Functional recovery', 'rate of delayed gastric emptying and clinically relevant postoperative pancreatic fistula', 'shorter hospital stay', 'hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0562018', 'cui_str': 'cent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0176940', 'cui_str': 'Distal subtotal pancreatectomy'}]","[{'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.263196,No difference was found in the complication rates (Clavien-Dindo grade III or above: 4 versus 8 patients respectively).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Björnsson', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'A Lindhoff', 'Initials': 'AL', 'LastName': 'Larsson', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hjalmarsson', 'Affiliation': 'Department of Surgery, Blekinge Hospital, Karlskrona, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Gasslander', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sandström', 'Affiliation': 'Department of Surgery and Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",The British journal of surgery,['10.1002/bjs.11554']
254,32259835,Process Evaluation of a Combined Lifestyle Intervention for Community-Dwelling Older Adults: ProMuscle in Practice.,"BACKGROUND AND OBJECTIVES
The ProMuscle in Practice intervention combines resistance exercise training and dietary protein intake for community-dwelling older adults, implemented by health care professionals (HCPs). This study aimed to evaluate implementation and context of this intervention in Dutch health care practice.
RESEARCH DESIGN AND METHODS
We conducted a randomized controlled multicenter intervention study in 5 Dutch municipalities. Eighty-two older adults received the 12-week intensive support intervention (resistance exercise training and individual dietary counseling) and the optional 12-week moderate support intervention (resistance exercise training and a nutrition course). Mixed method data were collected from both participants and HCPs (n = 37) on process indicators recruitment, dose received, acceptability, fidelity, applicability, and context.
RESULTS
Overall, the intervention was feasible to implement and accepted by participants and HCPs. About two thirds of participants continued with the moderate support intervention after the first 12 weeks. The mean dose received for the training sessions was 83.6% in the intensive intervention, 63.6% in the moderate intervention, >90% for individual dietitian consultations, and 76.8% for the nutrition course. The intensive support intervention was implemented with high fidelity, whereas for the moderate support intervention resistance exercise trainings varied in implementation between exercise providers.
DISCUSSION AND IMPLICATIONS
A combined resistance exercise training and dietary protein intervention for community-dwelling older adults can be successfully implemented in practice. Well-tailored interventions, intensive supervision by skilled HCPs, social aspects, fidelity, and fit within real-world settings appeared essential for successful implementation. These elements are important for continuous intervention optimization to accomplish broader and successful implementation.",2020,"The mean dose received for the training sessions was 83.6% in the intensive intervention, 63.6% in the moderate intervention,","['community-dwelling older adults, implemented by health care professionals (HCPs', 'Community-Dwelling Older Adults', '5 Dutch municipalities', 'Eighty-two older adults', 'community-dwelling older adults']","['resistance exercise training and dietary protein intake', 'intensive support intervention (resistance exercise training and individual dietary counseling) and the optional 12-week moderate support intervention (resistance exercise training and a nutrition course', 'Combined Lifestyle Intervention', 'resistance exercise training and dietary protein intervention']","['acceptability, fidelity, applicability, and context']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0425424', 'cui_str': 'Dietary protein intake'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0012177', 'cui_str': 'Proteins, Dietary'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449255', 'cui_str': 'Context'}]",82.0,0.0178004,"The mean dose received for the training sessions was 83.6% in the intensive intervention, 63.6% in the moderate intervention,","[{'ForeName': 'Ellen J I', 'Initials': 'EJI', 'LastName': 'van Dongen', 'Affiliation': 'Food, Health & Consumer Research, Wageningen Food & Biobased Research, Wageningen, The Netherlands.'}, {'ForeName': 'Esmée L', 'Initials': 'EL', 'LastName': 'Doets', 'Affiliation': 'Food, Health & Consumer Research, Wageningen Food & Biobased Research, Wageningen, The Netherlands.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Berber G', 'Initials': 'BG', 'LastName': 'Dorhout', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Annemien', 'Initials': 'A', 'LastName': 'Haveman-Nies', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands.'}]",The Gerontologist,['10.1093/geront/gnaa027']
255,32251303,Dietary restriction for prevention of contrast-induced acute kidney injury in patients undergoing percutaneous coronary angiography: a randomized controlled trial.,"Short-term dietary restriction (DR) may prevent organ damage from ischemic or toxic insults in animals, but clear evidence in humans is missing. While especially intraarterial administration of contrast media represents a cause of hospital-acquired acute kidney injury (AKI), targeted preventive strategies are not available. This trial investigated the feasibility and effectiveness of pre-interventional DR for preventing AKI in patients undergoing percutaneous coronary intervention (PCI). Patients were randomized to receive a formula diet containing 60% of daily energy requirement (DR group) or ad-libitum food during the 4-day-interval before PCI. Primary endpoint was change of serum creatinine 48 h after PCI (Δcreatinine). Further analyses included incidence of AKI and safety evaluation. Δcreatinine post PCI in the DR group vs. the control group did not show any difference (DR: 0.03(-0.15,0.14)mg/dL vs. control: 0.09(-0.03,0.22)mg/dL;p = 0.797). Subgroup analyses revealed a significant beneficial impact of DR in patients that received ≤100 ml of contrast agent (DR n = 26: Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n = 24: Δcreatinine 0.10(-0.08,0.24)mg/dL; p = 0.041) and in patients with ≤2 risk factors for AKI (DR: n = 27; Δcreatinine -0.01(-0.18,0.07)mg/dL vs. control n = 31: Δcreatinine 0.09(-0.03,0.16)mg/dl; p = 0.030). Although the primary endpoint was not met, the results of this trial suggest a beneficial impact of DR in low-to-moderate risk patients.",2020,"Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n = ","['patients that received ≤100', 'patients undergoing percutaneous coronary angiography', 'patients undergoing percutaneous coronary intervention (PCI']","['ml of contrast agent (DR n\u2009=\u200926', 'pre-interventional DR', 'formula diet containing 60% of daily energy requirement (DR group) or ad-libitum food', 'Δcreatinine 0.10(-0.08,0.24)mg/dL', 'dL vs. control', 'Dietary restriction', 'Short-term dietary restriction (DR', 'Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n\u2009']","['change of serum creatinine 48\u2009h after PCI (Δcreatinine', 'incidence of AKI and safety evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4517402', 'cui_str': '0.03'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.169756,"Δcreatinine -0.03(-0.20,0.08)mg/dL vs. control n = ","[{'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Grundmann', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany. franziska.grundmann@uk-koeln.de.'}, {'ForeName': 'Roman-Ulrich', 'Initials': 'RU', 'LastName': 'Müller', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Karla Johanna Ruth', 'Initials': 'KJR', 'LastName': 'Hoyer-Allo', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Martin Richard', 'Initials': 'MR', 'LastName': 'Späth', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Passmann', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Becker', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Pfister', 'Affiliation': 'Department III of Internal Medicine, Heart Center, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Baldus', 'Affiliation': 'Department III of Internal Medicine, Heart Center, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benzing', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Burst', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}]",Scientific reports,['10.1038/s41598-020-61895-2']
256,31637971,Intensive Blood Pressure Treatment Reduced Stroke Risk in Patients With Albuminuria in the SPRINT Trial.,"Background and Purpose- Albuminuria is associated with stroke risk among individuals with diabetes. However, the association of albuminuria with incident stroke among nondiabetic patients is less clear. Methods- We performed a post hoc analysis of the SPRINT (Systolic Blood Pressure Intervention Trial), which examined the effect of higher versus lower intensity blood pressure management on mortality in 8913 participants without diabetes. We fit unadjusted and adjusted Cox proportional hazards models to estimate the association of baseline albuminuria (urinary albumin-to-creatinine ratio ≥30 mg/g versus<30 mg/g) with stroke risk. We also assessed effect modification according to treatment arms. Results- Mean age was 68±9 years, 35% were female, and 30% were black. Median follow-up was 3.2 years, and 19% patients had baseline albuminuria. Incident stroke occurred in 129 individuals during follow-up. Albuminuria was associated with increased stroke risk (unadjusted hazard ratio, 2.24; 95% CI, 1.55-3.23; adjusted hazard ratio 1.73; 95% CI, 1.17-2.56). The association of albuminuria with incident stroke differed according to the randomized treatment arm ( P interaction=0.03). In the intensive treatment arm, the association of albuminuria and stroke was nonsignificant (unadjusted hazard ratio, 1.25; 95% CI, 0.69-2.28), whereas, in the standard treatment arm, it was significant (unadjusted hazard ratio, 3.44; 95% CI, 2.11-5.61). Conclusions- In a post hoc analysis of SPRINT, baseline albuminuria (versus not) was associated with a higher risk of incident stroke, but this relationship appeared to be restricted to those in the standard treatment arm. Further studies are required to conclusively determine if reduction of albuminuria in itself is beneficial in reducing stroke risk. Clinical Trial Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01206062.",2019,The association of albuminuria with incident stroke differed according to the randomized treatment arm ( P interaction=0.03).,"['8913 participants without diabetes', 'individuals with diabetes', 'nondiabetic patients', 'Mean age was 68±9 years, 35% were female, and 30% were black', 'Patients With Albuminuria in the SPRINT Trial']","['Methods', 'Conclusions', 'higher versus lower intensity blood pressure management', 'Intensive Blood Pressure Treatment']","['Stroke Risk', 'Albuminuria', 'Incident stroke', 'stroke risk', 'association of albuminuria and stroke', 'baseline albuminuria (urinary albumin-to-creatinine ratio ≥30']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1272452', 'cui_str': 'Manage blood pressure taking'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",129.0,0.296995,The association of albuminuria with incident stroke differed according to the randomized treatment arm ( P interaction=0.03).,"[{'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Leitão', 'Affiliation': 'From the Neurology Department, Centro Hospitalar Universitário Lisboa Central, Portugal (L.L.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Soares-Dos-Reis', 'Affiliation': 'Neurology Department (R.S.-d.-R.), Centro Hospitalar Universitário São João, Porto, Portugal.'}, {'ForeName': 'João Sérgio', 'Initials': 'JS', 'LastName': 'Neves', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism (J.S.N.), Centro Hospitalar Universitário São João, Porto, Portugal.'}, {'ForeName': 'Rute Baeta', 'Initials': 'RB', 'LastName': 'Baptista', 'Affiliation': 'Pediatrics Department, Hospital de Dona Estefânia, Centro Hospitalar Universitário de Lisboa Central, Portugal (R.B.B.).'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Bigotte Vieira', 'Affiliation': 'Nephrology Department, Hospital Curry Cabral, Centro Hospitalar Universitário de Lisboa Central, Lisbon, Portugal (M.B.V.).'}, {'ForeName': 'Finnian R', 'Initials': 'FR', 'LastName': 'Mc Causland', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital; and Harvard Medical School (F.R.M.C.).""}]",Stroke,['10.1161/STROKEAHA.119.026316']
257,31654725,Effects of the Active Smarter Kids (ASK) physical activity intervention on cardiometabolic risk factors in children: A cluster-randomized controlled trial.,"The onset of cardiometabolic diseases are recognized to occur in childhood. We aimed to investigate the effect of a school-based cluster-randomized controlled trial of physical activity (PA) on single and clustered cardiometabolic risk factors. We included 1129 fifth-grade children from 57 schools (≥seven children in each class) in Sogn and Fjordane County, Norway, randomized to 28 intervention schools and 29 control schools. The PA intervention was conducted between November 2014 and June 2015. Cardiometabolic risk factors were waist circumference (WC), systolic blood pressure (SBP), total cholesterol (TC):high-density lipoprotein (HDL)-ratio, triglycerides (TG), homeostatic model assessment (HOMA)-score, and cardiorespiratory fitness (CRF). PA was measured by accelerometry. No significant intervention effects were found for single or clustered cardiometabolic risk factors. However, in children with the less favorable baseline values, beneficial effects were found for SBP (p = 0.07 for group ∗ tertile interaction), TC:HDL ratio (p = 0.03 for group ∗ tertile interaction) and the clustered cardiometabolic risk score (p = 0.01 for group ∗ tertile interaction). Compared to boys, girls had a greater effect of the intervention on WC (p = 0.03 for group ∗ sex interaction) and CRF (p < 0.001 for group ∗ sex interaction). The majority of the children had high PA levels, thus limited potential for change, and we found no effects of the PA intervention on cardiometabolic risk in the total sample. However, the intervention had a significantly enhanced effect on fatness and fitness of girls compared to boys. Furthermore, the data suggest that children with the least favorable cardiometabolic risk profile and therefore most in need of change can benefit from school-based PA interventions. Trial registration number: Clinicaltrials.gov ID no.: NCT02132494.",2020,"Compared to boys, girls had a greater effect of the intervention on WC (p = 0.03 for group ∗ sex interaction) and CRF (p < 0.001 for group ∗ sex interaction).","['children', '1129 fifth-grade children from 57 schools (≥seven children in each class) in Sogn and Fjordane County, Norway']","['Active Smarter Kids (ASK) physical activity intervention', 'physical activity (PA', 'PA intervention']","['WC', 'cardiometabolic risk factors', 'clustered cardiometabolic risk score', 'Cardiometabolic risk factors were waist circumference (WC), systolic blood pressure (SBP), total cholesterol (TC):high-density lipoprotein (HDL)-ratio, triglycerides (TG), homeostatic model assessment (HOMA)-score, and cardiorespiratory fitness (CRF', 'fatness and fitness of girls', 'PA', 'cardiometabolic risk']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0028423', 'cui_str': 'Kingdom of Norway'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",1129.0,0.0272791,"Compared to boys, girls had a greater effect of the intervention on WC (p = 0.03 for group ∗ sex interaction) and CRF (p < 0.001 for group ∗ sex interaction).","[{'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Stavnsbo', 'Affiliation': 'Western Norway University of Applied Sciences, Department of Sport, Food and Natural Sciences, Sogndal, Norway; Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway. Electronic address: Mette.Stavnsbo@hvl.no.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Aadland', 'Affiliation': 'Western Norway University of Applied Sciences, Department of Sport, Food and Natural Sciences, Sogndal, Norway.'}, {'ForeName': 'Sigmund A', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': 'Western Norway University of Applied Sciences, Department of Sport, Food and Natural Sciences, Sogndal, Norway; Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Chinapaw', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam Public Health research institute, Department of Public and Occupational Health, Amsterdam, the Netherlands.'}, {'ForeName': 'Jostein', 'Initials': 'J', 'LastName': 'Steene-Johannessen', 'Affiliation': 'Norwegian School of Sport Sciences, Department of Sports Medicine, Oslo, Norway.'}, {'ForeName': 'Lars B', 'Initials': 'LB', 'LastName': 'Andersen', 'Affiliation': 'Western Norway University of Applied Sciences, Department of Sport, Food and Natural Sciences, Sogndal, Norway.'}, {'ForeName': 'Geir K', 'Initials': 'GK', 'LastName': 'Resaland', 'Affiliation': 'Western Norway University of Applied Sciences, Center for Physically Active Learning, Faculty of Education, Arts and Sports, Sogndal, Norway.'}]",Preventive medicine,['10.1016/j.ypmed.2019.105868']
258,31520215,Inverse association between changes in energetic cost of walking and vertical accelerations in non-metastatic breast cancer survivors.,"PURPOSE
With accelerometry, the utility to detect changes in physical activity are predicated on the assumption that walking energetics and gait mechanics do not change. The present work examined associations between changes (∆) in walking energetics, exercise self-efficacy, and several accelerometer-derived metrics.
METHODS
Secondary analyses were performed among a sub-sample (n = 29) of breast cancer survivors participating in a larger randomized trial. During 4 min of treadmill walking (0.89 m s -1 , 0% grade), indirect calorimetry quantified steady-state energy expenditure (EE), wherein, participants were fitted with a heart rate monitor and hip-worn triaxial accelerometer. Exercise self-efficacy was measured using a 9-item questionnaire, while vector magnitude (VM) and individual planes (e.g., mediolateral, vertical, and anteroposterior) of the movement were extracted for data analyses. Evaluations were made at baseline and after 3 months.
RESULTS
From baseline to 3 months, the energetic cost of walking (kcals min -1 ) significantly decreased by an average of - 5.1% (p = 0.001; d = 0.46). Conversely, VM significantly increased (p = 0.007; d = 0.53), exclusively due to greater vertical accelerations (acc) (+ 5.7 ± 7.8 acc; p = 0.001; d = 0.69). Changes in vertical accelerations were inversely and positively associated with ∆walking EE (r = - 0.37; p = 0.047) and ∆exercise self-efficacy (r = 0.39; p = 0.034), respectively.
CONCLUSION
Hip-worn accelerometers do not appear well-suited to correctly detect changes in ease of walking as evidenced by reduced energetic cost. Further research should determine if a divergence between measured EE and vertical accelerations could contribute to erroneous inferences in free-living physical activity.",2019,", the energetic cost of walking (kcals min -1 ) significantly decreased by an average of - 5.1% (p = 0.001; d = 0.46).","['Secondary analyses were performed among a sub-sample (n\u2009=\u200929) of breast cancer survivors participating in a larger randomized trial', 'non-metastatic breast cancer survivors']",[],"['changes (∆) in walking energetics, exercise self-efficacy, and several accelerometer-derived metrics', '9-item questionnaire, while vector magnitude (VM) and individual planes (e.g., mediolateral, vertical, and anteroposterior', 'energetic cost of walking (kcals\xa0min -1 ', '∆walking EE', 'energetic cost of walking and vertical accelerations', 'Exercise self-efficacy', 'Changes in vertical accelerations', '∆exercise self-efficacy']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442335', 'cui_str': 'Vectors (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0223058,", the energetic cost of walking (kcals min -1 ) significantly decreased by an average of - 5.1% (p = 0.001; d = 0.46).","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Carter', 'Affiliation': 'Department of Kinesiology, School of Public Health - Bloomington, Indiana University, 1025 East 7th Street SPH 046A, Bloomington, IN, 47405, USA. stjcarte@iu.edu.'}, {'ForeName': 'Laura Q', 'Initials': 'LQ', 'LastName': 'Rogers', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Heather R', 'Initials': 'HR', 'LastName': 'Bowles', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Maryland, 20892, USA.'}, {'ForeName': 'Lyse A', 'Initials': 'LA', 'LastName': 'Norian', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Hunter', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",European journal of applied physiology,['10.1007/s00421-019-04227-1']
259,32001813,"The influence of polymorphisms of fat mass and obesity (FTO, rs9939609) and vitamin D receptor (VDR, BsmI, TaqI, ApaI, FokI) genes on weight loss by diet and exercise interventions in non-diabetic overweight/obese Asian Indians in North India.","OBJECTIVE
The aim of the present study was to evaluate polymorphisms of fat mass and obesity (FTO; rs9939609) and vitamin D receptor (VDR, FokI (rs2228570), BsmI (rs1544410), ApaI (rs7975232), and TaqI (rs731236)] genes on weight loss after lifestyle interventions in Asian Indians.
METHODS
In this 6-month pre-post intervention trial, 110 overweight/obese men and women underwent diet and exercise interventions for 180 days resulting in reduction in body weight, (5.1 kg, p < 0.001), waist circumference, and skinfolds.
RESULTS
Association of the following genotypes was seen in those with ≥5% weight loss: TT of FTO polymorphism; 35 (81.4%) [OR (95% CI) AT, 2.5 (0.6, 10.9); TT, 6.9 (1.6, 28.2); with reference to AA], tt of VDR TaqI polymorphism, 12 (92.3%) [OR (95% CI); tt, 32.2 (2.4, 436.4); TT, 0.5 (0.08, 3.1); all with reference to Tt], bb of VDR BsmI polymorphism; 27 (65.8%) [OR (95% CI) Bb, 0.2 (0.04, 0.9); bb, 10.6 (0.9, 120.3); all with reference to BB] after adjusting for other genotypes. Further, analysis of combined influence of genotypes conferring maximum weight loss showed that the following had high odds of ≥5% weight loss: (1) TT of FTO gene in combination with BB/Bb of VDR BsmI and TT/Tt of VDR TaqI [OR (95% CI) 5.1 (1.5, 17.4)], (2) bb of BsmI and AA/AT of FTO and tt of TaqI [OR (95% CI) 3.2 (0.3, 31.7)], and (3) bb of BsmI plus TT of FTO and tt of TaqI.
CONCLUSIONS
The above observations suggest a significant and independent role of the genotypes of FTO and VDR in influencing weight loss after lifestyle intervention in Asian Indians.",2020,"RESULTS
Association of the following genotypes was seen in those with ≥5% weight loss: TT of FTO polymorphism; 35 (81.4%)","['non-diabetic overweight/obese Asian Indians in North India', 'Asian Indians', '110 overweight/obese men and women underwent']",['diet and exercise interventions'],"['weight loss', 'fat mass and obesity (FTO; rs9939609) and vitamin D receptor (VDR, FokI (rs2228570), BsmI (rs1544410), ApaI (rs7975232), and TaqI (rs731236)] genes on weight loss', 'fat mass and obesity (FTO, rs9939609) and vitamin D receptor (VDR, BsmI, TaqI, ApaI, FokI) genes on weight loss', 'maximum weight loss']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0108082', 'cui_str': 'Cholecalciferol Receptors'}, {'cui': 'C0066198', 'cui_str': 'methyl p-azidophenyl acetimidate'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]",110.0,0.11137,"RESULTS
Association of the following genotypes was seen in those with ≥5% weight loss: TT of FTO polymorphism; 35 (81.4%)","[{'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation, New Delhi, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation, New Delhi, India. anoopmisra@gmail.com.'}, {'ForeName': 'Rajneesh', 'Initials': 'R', 'LastName': 'Tiwari', 'Affiliation': 'National Diabetes, Obesity and Cholesterol Foundation (N-DOC), New Delhi, India.'}, {'ForeName': 'Meenu', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'National Diabetes, Obesity and Cholesterol Foundation (N-DOC), New Delhi, India.'}, {'ForeName': 'Ravindra M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'All India Institute of Medical Sciences, New Delhi, India.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0560-4']
260,32020057,"The role of appetite-related hormones, adaptive thermogenesis, perceived hunger and stress in long-term weight-loss maintenance: a mixed-methods study.","BACKGROUND/OBJECTIVES
Weight-loss maintenance is challenging, and few succeed in the long term. This study aimed to explain how appetite-related hormones, adaptive thermogenesis, perceived hunger and stress influence weight-loss maintenance.
SUBJECTS/METHODS
Fifteen adult women (age, 46.3 ± 9.5 years; BMI, 39.4 ± 4.3 kg/m 2 ) participated in a 24-month intervention, which included 3-5 months total diet replacement (825-853 kcal/d). Body weight and composition (Magnetic Resonance Imaging), resting metabolic rate (indirect calorimetry), and fasting plasma concentration of leptin, ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and growth differentiation factor 15 (GDF-15) were measured at baseline and after weight loss, around 6 months. Perceptions relating to weight-loss maintenance were explored using qualitative interviews.
RESULTS
Mean (SD) changes in body weight (-13.8 ± 6.3 kg) and total adipose tissue (-11.5 ± 4.9 kg) were significant (P < 0.001). Weight loss was associated with a significant reduction in resting metabolic rate (-291 ± 226 kcal/day, P < 0.001) and adaptive thermogenesis (-150 ± 162 kcal/day, P = 0.003), reduction in leptin (P < 0.001) and GLP-1 (P = 0.015), an increase in ghrelin (P < 0.001), and no changes in PYY and GDF-15. Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (r = 0.5, P = 0.037) and negatively with GLP-1 at baseline (r = -0.7, P = 0.003) and after weight loss (r = -0.7, P = 0.005). Participants did not report increased hunger after weight loss, and stress-related/emotional eating was perceived as the main reason for regain.
CONCLUSIONS
Weight regain is more likely with lower fasting GLP-1 and greater reduction in GLP-1 after weight loss, but psychological aspects of eating behaviour appear as important in attenuating weight-loss maintenance.",2020,"Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (","['Fifteen adult women (age, 46.3\u2009±\u20099.5 years']",[],"['Weight regain', 'resting metabolic rate', 'GLP-1', 'hunger after weight loss, and stress-related/emotional eating', 'Weight loss', 'adaptive thermogenesis', 'Body weight and composition (Magnetic Resonance Imaging), resting metabolic rate (indirect calorimetry), and fasting plasma concentration of leptin, ghrelin, glucagon-like peptide-1', 'Mean (SD) changes in body weight', 'reduction in leptin', 'weight loss', 'change in GLP-1 ', 'total adipose tissue', 'GLP-1), peptide YY (PYY), and growth differentiation factor 15 (GDF-15']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4235304', 'cui_str': 'Adaptive Thermogenesis'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0668195', 'cui_str': 'Prostate Differentiation Factor'}]",15.0,0.0274015,"Weight regain between 6 and 24 months (6.1 ± 6.3 kg, P < 0.05) was correlated positively with change in GLP-1 (","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thom', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Stephan U', 'Initials': 'SU', 'LastName': 'Dombrowski', 'Affiliation': 'Faculty of Kinesiology, University of New Brunswick, Fredericton, NB, Canada.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Brosnahan', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Yasmin Y', 'Initials': 'YY', 'LastName': 'Algindan', 'Affiliation': 'Department of Clinical Nutrition, College of Applied Medical Sciences, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rosario Lopez-Gonzalez', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Roditi', 'Affiliation': 'Department of Radiology, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Malkova', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow Royal Infirmary, Glasgow, UK. dalia.malkova@glasgow.ac.uk.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0568-9']
261,32266683,A Pilot Randomised Control Trial of Digitally-Mediated Social Stories for Children on the Autism Spectrum.,"Social stories is a widely used intervention for children on the autism spectrum, particularly within an educational context. To date, systematic reviews and meta analyses of the research evaluating social stories has produced mixed results, often due to a lack of methodological rigour and variability in the development and delivery of the social stories. To address the gap in methodological rigour, a pilot Randomised Control Trial (RCT) was conducted, incorporating a social stories intervention group (n = 9 children on the autism spectrum) and an attentional control group who received a poem (n = 6 children on the autism spectrum) using a digital platform to address variability. Digitally-mediated social stories were found to be effective in producing beneficial changes in behaviour outcomes, which were sustained at a six-week follow up.",2020,"Digitally-mediated social stories were found to be effective in producing beneficial changes in behaviour outcomes, which were sustained at a six-week follow up.","['Children on the Autism Spectrum', 'group (n\u2009=\u20099 children on the autism spectrum']","['social stories intervention', 'attentional control group who received a poem (n\u2009=\u20096 children on the autism spectrum', 'Digitally-Mediated Social Stories']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4304942', 'cui_str': 'POEM - Patient-Oriented Eczema Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",[],9.0,0.0265617,"Digitally-mediated social stories were found to be effective in producing beneficial changes in behaviour outcomes, which were sustained at a six-week follow up.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hanrahan', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Constantin', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brosnan', 'Affiliation': 'Centre for Applied Autism Research, Department of Psychology, University of Bath, Bath, BA2 7AY, UK. Pssmjb@bath.ac.uk.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04490-8']
262,32266567,"Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial.","PURPOSE
The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer.
METHODS
A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed.
RESULTS
The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events.
CONCLUSION
The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.",2020,"There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT.","['head and neck cancer', 'head and neck cancer patients (ESDOM']","['Dentoxol mouthrinse', 'placebo', 'radiation therapy (RT', 'Dentoxol', 'Dentoxol®', 'Dentoxol (n\u2009=\u200955) or control (n\u2009=\u200953) mouthrinse']","['mouth pain', 'mean duration of severe OM', 'incidence of severe OM', 'Efficacy and safety', 'severity of oral mucositis (OM', 'efficacy and safety', 'WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ', 'severe OM']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0720861,"There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT.","[{'ForeName': 'Rajesh V', 'Initials': 'RV', 'LastName': 'Lalla', 'Affiliation': 'Universityof Connecticut Health, Farmington, CT, USA. lalla@uchc.edu.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Solé', 'Affiliation': 'Clinica IRAM, Santiago, Chile.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Becerra', 'Affiliation': 'Instituto Nacional del Cáncer, Santiago, Chile.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Carvajal', 'Affiliation': 'Instituto Nacional del Cáncer, Santiago, Chile.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Bettoli', 'Affiliation': 'Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Letelier', 'Affiliation': 'Hospital Base Valdivia, Valdivia, Chile.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Santini', 'Affiliation': 'Centro Oncologico de Antofagasta, Antofagasta, Chile.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Vargas', 'Affiliation': 'Clinica IRAM, Santiago, Chile.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cifuentes', 'Affiliation': 'Instituto Nacional del Cáncer, Santiago, Chile.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Larsen', 'Affiliation': 'Clinica IRAM, Santiago, Chile.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Jara', 'Affiliation': 'Clinica IRAM, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Oyarzún', 'Affiliation': 'Hospital Base Valdivia, Valdivia, Chile.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feinn', 'Affiliation': 'Quinnipiac University, Hamden, CT, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Bustamante', 'Affiliation': 'Fundación Arturo López Pérez, Santiago, Chile.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Martínez', 'Affiliation': 'Universidad Mayor, Santiago, Chile.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenberg', 'Affiliation': 'Ingalfarma, SpA, Santiago, Chile.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Galván', 'Affiliation': 'Ingalfarma, SpA, Santiago, Chile.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05358-4']
263,32265291,"Effects of Inspiratory Load on Chest Wall Kinematics, Breathing Pattern, and Respiratory Muscle Activity of Mouth-Breathing Children.","BACKGROUND
We sought to evaluate the acute effects of different inspiratory loads using nasal and oral interfaces on the volumes of the chest wall and its compartments, breathing pattern, and respiratory muscle activation in children with mouth-breathing syndrome.
METHODS
Children with mouth-breathing syndrome were randomized into 2 groups, one with an inspiratory load intensity 20% of maximum inspiratory pressure ( n = 14), and the other with an inspiratory load intensity 40% of maximum inspiratory pressure ( n = 15). The chest wall volumes and electromyography of sternocleidomastoid, rectus abdominis, scalene, and internal intercostal muscles were used to analyze respiration against the 2 load intensities and using 2 interfaces (ie, nasal and oral).
RESULTS
A total of 72 children with mouth-breathing syndrome were recruited, and 29 were evaluated in this study. The use of inspiratory load promoted improvement in the components of the breathing pattern: breathing frequency ( P = .039), inspiratory time ( P = .03), and total respiratory time ( P = .043); and increases in tidal volume ( P < .001), end-inspiratory volume ( P < .001), and electrical activity of scalene muscles and sternocleidomastoid muscles ( P < .001) when compared to quiet breathing. The load imposed via a nasal interface versus an oral interface provided an increase in tidal volume ( P = .030), end-inspiratory volume ( P = .02), and electrical activity of scalene muscles ( P < .001) and sternocleidomastoid muscles ( P = .02).
CONCLUSIONS
The use of acute inspiratory loads improved the breathing pattern and increased lung volume and electrical activity of inspiratory muscles. This work brings new perspective to the investigation of using nasal interfaces during the application of inspiratory loads. The nasal interface was more effective compared to the oral interface commonly used in clinical practice.",2020,"The load imposed via a nasal interface versus an oral interface provided an increase in tidal volume ( P = .030), end-inspiratory volume ( P = .02), and electrical activity of scalene muscles ( P < .001) and sternocleidomastoid muscles ( P = .02).
","['72 children with mouth-breathing syndrome', 'children with mouth-breathing syndrome', 'Children with mouth-breathing syndrome']","['inspiratory load intensity 20% of maximum inspiratory pressure ( n = 14), and the other with an inspiratory load intensity 40% of maximum inspiratory pressure']","['inspiratory time', 'end-inspiratory volume', 'Chest Wall Kinematics, Breathing Pattern, and Respiratory Muscle Activity of Mouth-Breathing Children', 'electrical activity of scalene muscles', 'sternocleidomastoid muscles', 'breathing pattern and increased lung volume and electrical activity of inspiratory muscles', 'electrical activity of scalene muscles and sternocleidomastoid muscles', 'tidal volume', 'total respiratory time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}]","[{'cui': 'C0428686', 'cui_str': 'Inspiratory time'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0517967', 'cui_str': 'Respiratory pattern'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026635', 'cui_str': 'Mouth breathing'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",72.0,0.0312435,"The load imposed via a nasal interface versus an oral interface provided an increase in tidal volume ( P = .030), end-inspiratory volume ( P = .02), and electrical activity of scalene muscles ( P < .001) and sternocleidomastoid muscles ( P = .02).
","[{'ForeName': 'Jéssica Danielle Medeiros', 'Initials': 'JDM', 'LastName': 'da Fonsêca', 'Affiliation': 'PneumoCardioVascular Lab, Hospital Universitário Onofre Lopes, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Vanessa Regiane', 'Initials': 'VR', 'LastName': 'Resqueti', 'Affiliation': 'PneumoCardioVascular Lab, Hospital Universitário Onofre Lopes, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Kadja', 'Initials': 'K', 'LastName': 'Benício', 'Affiliation': 'PneumoCardioVascular Lab, Hospital Universitário Onofre Lopes, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Valéria Soraya', 'Initials': 'VS', 'LastName': 'de Farias Sales', 'Affiliation': 'Departamento de Análises Clínicas e Toxicológicas, Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Luciana Fontes Silva', 'Initials': 'LFS', 'LastName': 'da Cunha Lima', 'Affiliation': 'Departamento de Cirurgia, Universidade Federal do Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Aliverti', 'Affiliation': 'Dipartimento di Elettronica, Informazione e Bioingegneria, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sarmento', 'Affiliation': 'PneumoCardioVascular Lab, Hospital Universitário Onofre Lopes, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Guilherme Augusto', 'Initials': 'GA', 'LastName': 'de Freitas Fregonezi', 'Affiliation': 'PneumoCardioVascular Lab, Hospital Universitário Onofre Lopes, Natal, Rio Grande do Norte, Brazil. fregonezi.guilherme@gmail.com.'}]",Respiratory care,['10.4187/respcare.06908']
264,32267031,"The effect of aromatherapy with rose and lavender on anxiety, surgical site pain, and extubation time after open-heart surgery: A double-center randomized controlled trial.","To determine the effect of aromatherapy with rose and lavender on the patient outcomes after open-heart surgery (OHS). In the clinical trial, patients were randomized to four groups. One group received routine care, the placebo group received a cotton swab soaked in water and the other two groups received either a cotton swab containing three drops of rose or lavender essence (0.2 ml). A total of 160 patients were randomized into four groups. Intergroup anxiety was not significantly different; however, the reciprocal time-group effect was significant among the four groups. The extubation time was significant among the four groups which related to rose essence group compared with the control group (p < .001) and placebo group (p = .029). The surgical site pain was significant in the rose essence and lavender groups compared to the control group. Aromatherapy can reduce extubation time, surgical site pain severity, and anxiety in patients undergoing OHS.",2020,The extubation time was significant among the four groups which related to rose essence group compared with the control group (p < .001) and placebo group (p = .029).,"['patients undergoing OHS', '160 patients', 'patient outcomes after open-heart surgery (OHS', 'after open-heart surgery']","['aromatherapy with rose and lavender', 'placebo', 'cotton swab soaked', 'Aromatherapy', 'cotton swab containing three drops of rose or lavender essence', 'routine care, the placebo']","['extubation time', 'Intergroup anxiety', 'extubation time, surgical site pain severity, and anxiety', 'surgical site pain', 'anxiety, surgical site pain, and extubation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0268353', 'cui_str': 'Cutis laxa, x-linked'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0204774', 'cui_str': 'Soak'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",160.0,0.0958103,The extubation time was significant among the four groups which related to rose essence group compared with the control group (p < .001) and placebo group (p = .029).,"[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Babatabar Darzi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Vahedian-Azimi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Ghasemi', 'Affiliation': 'Trauma Research Center, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Ebadi', 'Affiliation': 'Behavioral Sciences Research Center, Life Style Institute, Nursing Faculty, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Thozhukat', 'Initials': 'T', 'LastName': 'Sathyapalan', 'Affiliation': 'Department of Academic Diabetes, Endocrinology and Metabolism, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Halal Research Center of IRI, FDA, Tehran, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6698']
265,32255542,"Randomized, Double-Blind, Single-Dose, Placebo-Controlled Crossover Study to Evaluate the Effects of Esaxerenone on QTc Interval in Healthy Subjects.","This phase 1 single-center, single-dose, double-dummy, placebo-controlled, 4-period and 4-sequence crossover study assessed the potential of esaxerenone, a novel nonsteroidal mineralocorticoid receptor blocker used to treat hypertension, to affect cardiac repolarization. In this double-blind study, 55 subjects were randomized to single doses of 10 mg esaxerenone (therapeutic dose), 40 mg esaxerenone (supratherapeutic dose), 400 mg moxifloxacin, or placebo. Serial electrocardiograms and pharmacokinetics (PK) were obtained over 24 and 168 hours, respectively. The primary end point was Fridericia-corrected QT interval (QTcF). Secondary end points included safety and PK. Assay sensitivity was confirmed as the lower limit of 90% confidence interval (90%CIs) for placebo-corrected change from baseline QTcF (∆∆QTcF) for moxifloxacin was >5 milliseconds at the prespecified times; mean ∆∆QTcF was 12.5 milliseconds at 3 and 4 hours postdose. The upper 90%CI limits of ∆∆QTcF were ≤0 milliseconds at all times for both doses of esaxerenone. No concentration-QTc relationship was identified. Therefore, esaxerenone had no potential to inhibit cardiac repolarization. No deaths or serious adverse events (AEs) occurred; 1 subject discontinued the study because of a treatment-emergent AE unrelated to esaxerenone. This clinical evaluation showed that esaxerenone has no QTc prolongation potential.",2020,The upper 90%CI limits of ∆∆QTcF were ≤0 milliseconds at all times for both doses of esaxerenone.,"['55 subjects', 'Healthy Subjects']","['esaxerenone', 'Placebo', 'esaxerenone (therapeutic dose), 40 mg esaxerenone (supratherapeutic dose), 400 mg moxifloxacin, or placebo', 'Esaxerenone', 'moxifloxacin']","['Assay sensitivity', 'concentration-QTc relationship', 'deaths or serious adverse events', 'Fridericia-corrected QT interval (QTcF', 'safety and PK', 'Serial electrocardiograms and pharmacokinetics (PK']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C5139864', 'cui_str': 'esaxerenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",55.0,0.285919,The upper 90%CI limits of ∆∆QTcF were ≤0 milliseconds at all times for both doses of esaxerenone.,"[{'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Mendell', 'Affiliation': 'Daiichi Sankyo Pharma Development, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Kobayashi', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Daiichi Sankyo Co., Ltd., Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.794']
266,31408838,APOE gene-dependent BOLD responses to a breath-hold across the adult lifespan.,"Age and apolipoprotein E (APOE) e4 genotype are two of the strongest known risk factors for sporadic Alzheimer's disease (AD). Neuroimaging has shown hemodynamic response changes with age, in asymptomatic carriers of the APOE e4 allele, and in AD. In this study, we aimed to characterize and differentiate age- and APOE gene-specific hemodynamic changes to breath-hold and visual stimulation. A further aim was to study whether these responses were modulated by 3-day intake of nitrate, a nitric oxide (NO) source. The study was designed as a randomized, double-blinded, placebo-controlled crossover study, and the study cohort comprised 41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70 years at enrollment. The participants underwent two scanning sessions, each preceded by ingestion of sodium nitrate or sodium chloride (control). During functional magnetic resonance imaging (fMRI) sessions, participants performed two concurrent tasks; a breath-hold task to probe cerebrovascular reactivity and a visual stimulation task to evoke functional hyperemia, respectively. We found that the blood oxygenation level dependent (BOLD) hemodynamic response to breath-hold was altered in APOE e4 carriers relative to non-carriers. Mid-aged (50-60 years of age) e4 carriers exhibited a significantly increased peak time relative to mid-aged e3 carriers, and peak time for younger (30-40 years of age) e4 carriers was significantly shorter than that of mid-aged e4 carriers. The response width was significantly increased for e4 carriers. The response peak magnitude significantly decreased with age. For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type. We found no effect of nitrate ingestion on BOLD responses evoked by the breath-hold and visual stimulation tasks. The APOE gene-dependent response to breath-hold may reflect NO-independent differences in vascular function.",2019,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.",['41 APOE e4 carriers (e3/e4 or e4/e4 genotype) and 40 non-carriers (e3/e3 genotype) aged 30-70\u202fyears at enrollment'],"['sodium nitrate or sodium chloride (control', 'placebo', 'functional magnetic resonance imaging (fMRI) sessions', 'nitrate ingestion']","['response peak magnitude', 'blood oxygenation level dependent (BOLD) hemodynamic response', 'peak time relative', 'response width', 'Age and apolipoprotein E (APOE']","[{'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0074748', 'cui_str': 'sodium nitrate'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0523511', 'cui_str': 'Apolipoproteins E measurement (procedure)'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}]",,0.218788,"For the visual stimulation task, we found age-related changes, with reduced response magnitude with age but no significant effect of APOE allele type.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Rasmussen', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: pmr@cfin.au.dk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Aamand', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Weitzberg', 'Affiliation': 'Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christiansen', 'Affiliation': 'Department for Congenital Disorders, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Torben E', 'Initials': 'TE', 'LastName': 'Lund', 'Affiliation': 'Center of Functionally Integrative Neuroscience, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101955']
267,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8']
268,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992']
269,31433058,A longitudinal analysis of albendazole treatment effect on neurocysticercosis cyst evolution using multistate models.,"BACKGROUND
In neurocysticercosis, the larval form of the pork tapeworm Taenia solium appears to evolve through three phases-active, degenerative and sometimes calcification-before disappearance. The antihelmintic drug, albendazole, has been shown to hasten the resolution of active cysts in neurocysticercosis. Little is known about the time cysts take to progress through each phase, with or without treatment.
METHODS
We reconfigured brain imaging data from patient level to cyst level for 117 patients in a randomized clinical trial of albendazole in which images were taken at baseline, 1, 6, 12 and 24 mo. Applying a multistate model, we modelled the hazard of a cyst evolving to subsequent cyst phases before the next imaging (vs no change). We examined the impact of albendazole treatment overall and by patient and cyst characteristics on the hazard.
RESULTS
Albendazole accelerated the evolution from the active to degenerative phase (HR=2.7, 95% CI 1.3 to 6.5) and from the degenerative phase to disappearance (HR=1.9, 95% CI 1.1 to 3.9). Albendazole's impact was stronger for patients who were male, did not have calcified cysts at baseline and who had multiple cysts in different locations.
CONCLUSIONS
This research provides a better understanding of where in the cyst trajectory albendazole has the greatest impact.",2019,"Albendazole's impact was stronger for patients who were male, did not have calcified cysts at baseline and who had multiple cysts in different locations.
",['patient level to cyst level for 117 patients'],"['Albendazole', 'albendazole']",['neurocysticercosis cyst evolution'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]","[{'cui': 'C0001911', 'cui_str': 'Albendazole'}]","[{'cui': 'C0338437', 'cui_str': 'Cysticercosis, Brain'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}]",117.0,0.124218,"Albendazole's impact was stronger for patients who were male, did not have calcified cysts at baseline and who had multiple cysts in different locations.
","[{'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Montgomery', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Kelvin', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Carpio', 'Affiliation': 'School of Medicine, University of Cuenca, Av 12 de Abril s/n Ciudadela Universitaria, 010201 Cuenca, Ecuador.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jaramillo', 'Affiliation': 'Instituto de Diagnóstico por Imágenes, Inés Salcedo 1-99, Cuenca, Ecuador.'}, {'ForeName': 'W Allen', 'Initials': 'WA', 'LastName': 'Hauser', 'Affiliation': 'Gertrude H. Sergievsky Center, Vagelos College of Physicians and Surgeons, 630 168th Street, Columbia University, New York, New York 10032, USA.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, CUNY Graduate School of Public Health and Health Policy, City University of New York, 55 West 125th Street, New York, New York 10027, USA.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/trz073']
270,32251146,"Drilling Energy Correlates With Screw Insertion Torque, Screw Compression, and Pullout Strength: A Cadaver Study.","INTRODUCTION
To determine whether drilling energy correlates with bone mineral density (BMD), maximum insertion torque (MIT), maximum screw compression, and pullout strength (POS).
METHODS
Ten cadaver tibias were used for testing. Unicortical pilot holes were drilled and the drilling energy measured. Drill site bone quality was determined with microcomputed tomography. Drill holes were randomly assigned to POS or MIT testing using 3.5-mm cortical screws engaging only the near cortex. Pearson correlation coefficients were calculated to determine the relationship between drilling energy, BMD, POS, MIT, and maximum screw compression.
RESULTS
Drilling energy was correlated with BMD (P < 0.001). Compared with BMD, drilling energy had a better correlation with MIT, maximum screw compression, and POS. Maximum screw compression also correlated with MIT (P = 0.012).
CONCLUSIONS
Drilling energy better correlates with MIT, maximum screw compression, and POS compared with BMD in cadaver cortical bone. Dynamically measuring drilling energy may help inform the orthopaedic surgeon as to the quality of the bone before insertion of implants.",2020,"Compared with BMD, drilling energy had a better correlation with MIT, maximum screw compression, and POS.",['Ten cadaver tibias were used for testing'],['POS or MIT testing using 3.5-mm cortical screws engaging only the near cortex'],"['MIT, maximum screw compression, and POS', 'BMD', 'bone mineral density (BMD), maximum insertion torque (MIT), maximum screw compression, and pullout strength (POS', 'Drill site bone quality', 'drilling energy, BMD, POS, MIT, and maximum screw compression', 'Maximum screw compression']","[{'cui': 'C0006629', 'cui_str': 'Cadaver'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0337279', 'cui_str': 'Drilling - action'}]",,0.0521969,"Compared with BMD, drilling energy had a better correlation with MIT, maximum screw compression, and POS.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'From the Department of Orthopaedic Surgery, Stanford University Medical Center, Redwood City, CA.'}, {'ForeName': 'Malcolm R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Thio', 'Affiliation': ''}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Storaci', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Gardner', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-19-00366']
271,31670070,Evidence for decreased Neurologic Pain Signature activation following thoracic spinal manipulation in healthy volunteers and participants with neck pain.,"BACKGROUND CONTEXT
Spinal manipulation (SM) is a common treatment for neck and back pain, theorized to mechanically affect the spine leading to therapeutic mechanical changes. The link between specific mechanical effects and clinical improvement is not well supported. SM's therapeutic action may instead be partially mediated within the central nervous system.
PURPOSE
To introduce brain-based models of pain for spinal pain and manual therapy research, characterize the distributed central mechanisms of SM, and advance the preliminary validation of brain-based models as potential clinical biomarkers of pain.
STUDY DESIGN
Secondary analysis of two functional magnetic resonance imaging studies investigating the effect of thoracic SM on pain-related brain activity: A non-controlled, non-blinded study in healthy volunteers (Study 1, n = 10, 5 females, and mean age = 31.2 ± 10.0 years) and a randomized controlled study in participants with acute to subacute neck pain (Study 2, n = 24, 16 females, mean age = 38.0 ± 15.1 years).
METHODS
Functional magnetic resonance imaging was performed during noxious mechanical stimulation of the right index finger cuticle pre- and post-intervention. The effect of SM on pain-related activity was studied within brain regions defined by the Neurologic Pain Signature (NPS) that are predictive of physical pain.
RESULTS
In Study 1, evoked mechanical pain (p < 0.001) and NPS activation (p = 0.010) decreased following SM, and the changes in evoked pain and NPS activation were correlated (r RM 2 = 0.418, p = 0.016). Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2 = 0.477, p = 0.019). In Study 2, neck pain (p = 0.046) and NPS (p = 0.033) activation decreased following verum but not sham SM. Associations between evoked pain, neck pain, and NPS activation, were not significant and less clear, possibly due to inadequate power, methodological limitations, or other confounding factors.
CONCLUSIONS
The findings provide preliminary evidence that SM may alter the processing of pain-related brain activity within specific pain-related brain regions and support the use of brain-based models as clinical biomarkers of pain.",2019,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2 = 0.477, p = 0.019).","['healthy volunteers (Study 1, n\u202f=\u202f10, 5 females, and mean age\u202f=\u202f31.2\u202f±\u202f10.0 years', 'participants with acute to subacute neck pain (Study 2, n\u202f=\u202f24, 16 females, mean age\u202f=\u202f38.0\u202f±\u202f15.1 years', 'healthy volunteers and participants with neck pain']","['SM', 'thoracic SM', 'thoracic spinal manipulation']","['dACC activity', 'evoked mechanical pain', 'NPS activation', 'pain-related activity', 'Neurologic Pain Signature activation', 'evoked pain and NPS activation', 'NPS', 'SM, and evoked pain', 'neck pain', 'evoked pain, neck pain, and NPS activation', 'pain-related brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0234252', 'cui_str': 'Mechanical pain (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",,0.0871702,"Activation within the NPS subregions of the dorsal anterior cingulate cortex (dACC, p = 0.012) and right secondary somatosensory cortex/operculum (rS2_Op, p = 0.045) also decreased following SM, and evoked pain was correlated with dACC activity (r RM 2 = 0.477, p = 0.019).","[{'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Weber Ii', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States. Electronic address: kenweber@stanford.edu.'}, {'ForeName': 'Tor D', 'Initials': 'TD', 'LastName': 'Wager', 'Affiliation': 'Psychology and Neuroscience, Center for Neuroscience, Institute of Cognitive Science, University of Colorado Boulder, Boulder, CO, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Mackey', 'Affiliation': 'Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University, Palo Alto, CA, United States.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Elliott', 'Affiliation': 'Northern Sydney Local Health District, The Kolling Research Institute and The Faculty of Health Sciences, The University of Sydney, St. Leonards, NSW, Australia.'}, {'ForeName': 'Wen-Ching', 'Initials': 'WC', 'LastName': 'Liu', 'Affiliation': 'Center for Collaborative Brain Research, Department of Radiology, OSF HealthCare Saint Francis Medical Center, Peoria, IL, United States.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Sparks', 'Affiliation': 'Center of Expertise, Rehabilitation and Occupational Health, OSF HealthCare, Peoria, IL, United States; School of Physical Therapy, South College, Knoxville, TN, United States.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102042']
272,30003027,"Pharmacological fMRI: Effects of subanesthetic ketamine on resting-state functional connectivity in the default mode network, salience network, dorsal attention network and executive control network.","Background
Subanesthetic dosages of the NMDAR antagonist, S-Ketamine, can cause changes in behavior in healthy subjects, which are similar to the state acute psychosis and are relevant in translational schizophrenia research. Functional magnetic resonance imaging (fMRI) can be used for non-hypothesis-driven analysis of brain connectivity. The correlation between clinical behavioral scores and neuroimaging can help to characterize ketamine effects on healthy brains in resting state.
Method
seventeen healthy, male subjects (mean: 27.42 years, SD: 4.42) were administered an infusion with S-Ketamine (initial bolus 1 mg/kg and continuous infusion of 0.015625 mg/kg/min with dosage reduction -10%/10 min) or saline in a randomized, double-blind, cross-over study. During infusion, resting state connectivity was measured and analyzed with a seed-to-voxel fMRI analysis approach. The seed regions were located in the posterior cingulate cortex, intraparietal sulcus, dorsolateral prefrontal cortex and fronto-insular cortex. Receiver operating characteristics (ROC) were calculated to assess the accuracy of the ketamine-induced functional connectivity changes. Bivariate Pearson correlation was used for correlation testing of functional connectivity changes with changes of clinical scores (PANSS, 5D-ASC).
Results
In the executive network (ECN), ketamine significantly increases the functional connectivity with parts of the anterior cingulum and superior frontal gyrus, but no significant correlations with clinical symptoms were found. Decreased connectivity between the salience network (SN) and the calcarine fissure was found, which is significantly correlated with negative symptoms (PANSS) (R2 > 0.4).
Conclusion
Decreased ketamine-induced functional connectivity in the salience network may qualify as accurate and highly predictive biomarkers for ketamine induced negative symptoms.",2018,"In the executive network (ECN), ketamine significantly increases the functional connectivity with parts of the anterior cingulum and superior frontal gyrus, but no significant correlations with clinical symptoms were found.","['healthy brains in resting state', 'healthy subjects', 'Method\n\n\nseventeen healthy, male subjects (mean: 27.42\u202fyears, SD: 4.42']","['Functional magnetic resonance imaging (fMRI', 'executive network (ECN), ketamine', 'infusion with S-Ketamine (initial bolus 1\u202fmg/kg and continuous infusion of 0.015625\u202fmg/kg/min with dosage reduction -10%/10\u202fmin) or saline', 'NMDAR antagonist, S-Ketamine', 'subanesthetic ketamine']","['resting-state functional connectivity', 'functional connectivity']","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517762', 'cui_str': '4.42'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C1320756', 'cui_str': 'mg/kg/min'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",17.0,0.0989254,"In the executive network (ECN), ketamine significantly increases the functional connectivity with parts of the anterior cingulum and superior frontal gyrus, but no significant correlations with clinical symptoms were found.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mueller', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), Dept. of Anesthesiology and Intensive Care Medicine, Charité - University Medicine Berlin, Germany. Electronic address: felix.mueller@charite.de.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Musso', 'Affiliation': 'Department of Psychiatry, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'London', 'Affiliation': 'Janssen-Cilag GmbH, Early Development and Clinical Pharmacology, Neuss, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Boer', 'Affiliation': 'Janssen Pharmaceutica, Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Zacharias', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), Dept. of Anesthesiology and Intensive Care Medicine, Charité - University Medicine Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Winterer', 'Affiliation': 'Experimental and Clinical Research Center (ECRC), Dept. of Anesthesiology and Intensive Care Medicine, Charité - University Medicine Berlin, Germany; Pharmaimage Biomarker Solutions GmbH, Berlin, Germany; Pharmaimage Biomarker Solutions Inc., Boston, USA.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2018.05.037']
273,32221332,A Randomized Trial Comparing the Bowel Cleansing Efficacy of Sodium Picosulfate/Magnesium Citrate and Polyethylene Glycol/Bisacodyl (The Bowklean Study).,"Bowel cleansing is essential for a successful colonoscopy, but the ideal clearing agent and the volume have yet to be determined. A small-volume cleanser is important for patient compliance. This study aimed to compare the bowel cleansing efficacy, safety, tolerability, and acceptability of a 300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation under identical dietary recommendations. This multicenter, randomized, parallel-group, pre-specified noninferiority study enrolled 631 outpatients scheduled to undergo colonoscopy (Bowklean = 316 and Klean-Prep/Dulcolax = 315). After bowel preparation, an independent evaluator blinded to the subject's treatment allocation rated the quality of the colon cleansing. Efficacy was evaluated using the Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS). Safety was assessed by monitoring adverse events. Tolerability and acceptability were measured via a patient questionnaire. Bowklean was non-interior to Klean-Prep/Dulcolax in overall colon cleansing but was associated with significantly better preparation quality. Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax. Safety profiles did not differ significantly between the groups. Our data indicate that Bowklean is a more effective and better-tolerated bowel cleansing preparation before colonoscopy than Klean-Prep/Dulcolax. Bowklean may therefore increase positive attitudes toward colonoscopies and participation rates.",2020,"Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax.",['631 outpatients scheduled to undergo colonoscopy (Bowklean\u2009=\u2009316 and Klean-Prep/Dulcolax\u2009=\u2009315'],"['300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation', 'Sodium Picosulfate/Magnesium Citrate and Polyethylene', 'Glycol/Bisacodyl']","['tolerability and acceptability of bowel preparations', 'Tolerability and acceptability', 'bowel cleansing efficacy, safety, tolerability, and acceptability', 'Safety', 'Efficacy', 'Safety profiles', 'Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0674963', 'cui_str': 'klean prep'}, {'cui': 'C0591416', 'cui_str': 'Dulcolax'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0071042', 'cui_str': 'picosulfate sodium'}, {'cui': 'C0126774', 'cui_str': 'magnesium citrate'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0674963', 'cui_str': 'klean prep'}, {'cui': 'C0591416', 'cui_str': 'Dulcolax'}, {'cui': 'C0137914', 'cui_str': 'Polythene'}, {'cui': 'C0017951', 'cui_str': 'Glycols'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0222045'}]",631.0,0.0513847,"Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax.","[{'ForeName': 'Shih-Ya', 'Initials': 'SY', 'LastName': 'Hung', 'Affiliation': 'Graduate Institute of Acupuncture Science, China Medical University, Taichung, 40402, Taiwan.'}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Chen', 'Affiliation': 'Department of Colorectal Surgery, China Medical University Hospital, Taichung, 40447, Taiwan.'}, {'ForeName': 'William Tzu-Liang', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Colorectal Surgery, China Medical University Hospital, Taichung, 40447, Taiwan. wtchen@mail.cmuh.org.tw.'}]",Scientific reports,['10.1038/s41598-020-62120-w']
274,31916465,Costs associated with renal and cardiovascular events among patients with type 2 diabetes mellitus and nephropathy: a cost model based on the CREDENCE clinical trial.,"Objective: To estimate the avoided costs associated with reductions in end-stage kidney disease (ESKD), certain CV events (non-fatal myocardial infarction [MI], non-fatal stroke, hospitalization for heart failure [HHF]), and renal and CV death for patients treated with canagliflozin versus placebo, based on CREDENCE trial results. Methods: Renal (including ESKD) and CV events averted, based on the differences in adjusted rates of events between the canagliflozin and placebo arms in CREDENCE, were projected to the proportion of the members of a managed care organization (MCO) fitting the inclusion criteria in CREDENCE (i.e. diabetic nephropathy, at least 30 years old). The number of events averted for the population was multiplied by the unit-cost of the event, extracted from a targeted literature review, to obtain costs avoided per member per year (PMPY). One-way sensitivity analysis provided a range for the cost avoided PMPY, based on variations in the events averted, unit cost and size of the projected population. Results: Costs avoided PMPY were $2.92 for ESKD with a range of $1.28-$4.20. Costs avoided PMPY were $0.54 (-$0.28-$1.16) for non-fatal MI, $0.30 (-$0.22-$0.65) for non-fatal stroke, $1.56 ($0.80-$2.11) for HHF, $0.06 ($0.05-$0.07) for renal death, and $0.51 ($0.00-$0.91) for CV death. For non-fatal MI and non-fatal stroke, the lower bound of the range is interpreted as an incremental cost. Conclusions: Positive costs avoided for each of the outcomes considered were predicted in the main analysis, with ESKD as the outcome predicted to have the greatest costs avoided at $2.92 PMPY.",2020,"Costs avoided PMPY were $0.54 (-$0.28-$1.16) for non-fatal MI, $0.30 (-$0.22-$0.65) for non-fatal stroke, $1.56 ($0.80-$2.11) for HHF, $0.06 ($0.05-$0.07) for renal death, and $0.51 ($0.00-$0.91) for CV death.",['patients with type 2 diabetes mellitus and nephropathy'],['canagliflozin versus placebo'],"['renal death', 'Costs avoided PMPY', 'renal and cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.0253095,"Costs avoided PMPY were $0.54 (-$0.28-$1.16) for non-fatal MI, $0.30 (-$0.22-$0.65) for non-fatal stroke, $1.56 ($0.80-$2.11) for HHF, $0.06 ($0.05-$0.07) for renal death, and $0.51 ($0.00-$0.91) for CV death.","[{'ForeName': 'Ameur M', 'Initials': 'AM', 'LastName': 'Manceur', 'Affiliation': 'Analysis Group, Inc, Montréal, Canada.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Durkin', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Kharat', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Bookhart', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Lafeuille', 'Affiliation': 'Analysis Group, Inc, Montréal, Canada.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Pilon', 'Affiliation': 'Analysis Group, Inc, Montréal, Canada.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Fakih', 'Affiliation': 'Analysis Group, Inc, Montréal, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lefebvre', 'Affiliation': 'Analysis Group, Inc, Montréal, Canada.'}]",Current medical research and opinion,['10.1080/03007995.2019.1708285']
275,32250061,The influence of submerged healing abutment or subcrestal implant placement on soft tissue thickness and crestal bone stability. A 2-year randomized clinical trial.,"PURPOSE
Aims of the study were: (a) to register crestal bone loss around 1.5 mm subcrestally placed implants and epicrestally placed implants with soft tissue tenting technique, (b) to record bone remodeling in subcrestal group, and (c) to determine the increase of vertical soft tissues after tenting.
MATERIALS AND METHODS
Thirty-two patients with vertically thin tissues of 2 mm or less received 40 submerged bone level platform-switched implants, divided into two groups-(a) 1.5 mm subcrestally placed implants and (b) epicrestally placed implants with soft tissue tenting over 2 mm healing abutments. At the second stage surgery, implants received 4 mm healing abutments, soft tissue thickness was measured in epicrestal group, and later implants were restored with zirconia-based screw-retained single restorations. Radiological images were taken at the second stage surgery, restoration delivery and after 2 years of follow-up. Bone loss was calculated as a distance between implant neck and first radiographically visible bone-to-implant contact. Bone remodeling was calculated as a distance between the bone crest and implant neck. Mann-Whitney U test was used for statistical analysis, significance set to 0.05.
RESULTS
After 2 years of follow-up, Group 1 (subcrestal) had 0.18 ± 0.32 mm of bone loss, Group 2 (epicrestal with 2 mm healing abutment) had 0.51 ± 0.4 mm of bone loss, with statistically significant difference (P = .001). Bone remodeling in Group 1 (subcrestal) was 1.17 ± 0.51 mm. Vertical tissue thickness in epicrestal group before the intervention was 1.85 ± 0.26 and 3.65 ± 0.41 mm after the use of 2 mm healing abutment, with a statistical difference (P = .005).
CONCLUSION
Subcrestal implant placement can significantly reduce crestal bone loss, compared to vertical soft tissue thickening by tenting of epicrestally placed implants, although soft tissue tenting can significantly increase soft tissue thickness.",2020,"Vertical tissue thickness in epicrestal group before the intervention was 1.85 ± 0.26 and 3.65 ± 0.41 mm after the use of 2 mm healing abutment, with a statistical difference (P = .005).
",['Thirty-two patients with vertically thin tissues of 2\u2009mm or less received'],"['40\u2009submerged bone level platform-switched implants, divided into two groups-(a) 1.5\u2009mm subcrestally placed implants and (b) epicrestally placed implants with soft tissue tenting over 2\u2009mm healing abutments', 'crestal bone loss around 1.5\u2009mm subcrestally placed implants and epicrestally placed implants with soft tissue tenting technique, (b) to record bone remodeling', 'submerged healing abutment or subcrestal implant placement', 'zirconia-based screw-retained single restorations', 'Subcrestal implant placement']","['Vertical tissue thickness', 'soft tissue thickness and crestal bone stability', 'bone loss', 'Bone loss', 'soft tissue thickness', 'crestal bone loss', 'Bone remodeling']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C3266125', 'cui_str': 'Healing abutment'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",32.0,0.0255518,"Vertical tissue thickness in epicrestal group before the intervention was 1.85 ± 0.26 and 3.65 ± 0.41 mm after the use of 2 mm healing abutment, with a statistical difference (P = .005).
","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Linkevicius', 'Affiliation': 'Institute of Odontology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}, {'ForeName': 'Algirdas', 'Initials': 'A', 'LastName': 'Puisys', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Rokas', 'Initials': 'R', 'LastName': 'Linkevicius', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Alkimavicius', 'Affiliation': 'Vilnius Research Group, Vilnius, Lithuania.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Gineviciute', 'Affiliation': 'Private Practice, Vilnius, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linkeviciene', 'Affiliation': 'Institute of Odontology, Faculty of Medicine, Vilnius University, Vilnius, Lithuania.'}]",Clinical implant dentistry and related research,['10.1111/cid.12903']
276,31729127,Renal protection: What have we learnt from ADVANCE about kidney disease in type 2 diabetes?,"The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial was a landmark randomized controlled clinical trial in 11 140 type 2 diabetic patients from 215 centers in 20 countries with a two-by-two factorial design. In the blood pressure-lowering arm, patients were treated using a fixed combination of the ACE-inhibitor, perindopril, and the thiazide-like diuretic, indapamide, or placebo, whereas in the glucose-lowering arm, the intervention compared the sulphonylurea gliclazide plus other glucose-lowering drugs, targeting a glycated hemoglobin value of 6.5% or less, with standard glucose control. Primary end-points were major macro- and microvascular events in both arms. This review gives an overview of the results of the primary randomized trial, results from observational follow-up studies, and results of several biomarker studies and discusses the perspectives of these data in the context of recent major outcome trials for current medical treatment.",2020,Primary end-points were major macro- and microvascular events in both arms.,"['11,140 type 2 diabetic patients from 215 centers in 20 countries with a two-by-two factorial design']","['ACE-inhibitor, perindopril, and the thiazide-like diuretic, indapamide, or placebo', 'standard glucose control', 'sulphonylurea gliclazide plus other glucose-lowering drugs']","['major macro- and microvascular events', 'Renal Protection']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0136123', 'cui_str': 'Perindopril'}, {'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0021186', 'cui_str': 'Indapamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.207933,Primary end-points were major macro- and microvascular events in both arms.,"[{'ForeName': 'Søren T', 'Initials': 'ST', 'LastName': 'Knudsen', 'Affiliation': 'Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Monash University Central Clinical School, Melbourne, VIC, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13917']
277,32248626,Efficacy of a Physical Activity Counseling Program With Use of a Wearable Tracker in People With Inflammatory Arthritis: A Randomized Controlled Trial.,"OBJECTIVE
To assess the efficacy of a multifaceted counseling intervention at improving physical activity participation and patient outcomes.
METHODS
We recruited people with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). In weeks 1-8, the immediate group received education and counseling by a physical therapist, used a Fitbit and a web application to obtain feedback about their physical activity, and received 4 follow-up calls from the physical therapist. The delay group received the same intervention in weeks 10-17. Participants were assessed at baseline and at weeks 9, 18, and 27. The primary outcome was time spent in moderate/vigorous physical activity (MVPA; in bouts of ≥10 minutes) measured with a SenseWear device. Secondary outcomes included step count, time in sedentary behavior, pain, fatigue, mood, self-management capacity, and habitual behaviors.
RESULTS
A total of 118 participants enrolled. The adjusted mean difference in MVPA was 9.4 minutes/day (95% confidence interval [95% CI] -0.5, 19.3, P = 0.06). A significant effect was found in pain (-2.45 [95% CI -4.78, -0.13], P = 0.04), and perceived walking habit (0.54 [95% CI 0.08, 0.99], P = 0.02). The remaining secondary outcomes improved, but were not statistically significant. Post hoc analysis revealed a significant effect in MVPA (14.3 minutes/day [95% CI 2.3, 26.3]) and pain (-4.05 [95% CI -6.73, -1.36]) in participants with RA, but not in those with SLE.
CONCLUSION
Counseling by a physical therapist has the potential to improve physical activity in people with inflammatory arthritis, but further study is needed to understand the intervention effect on different diseases. We found a significant improvement in pain, suggesting that the intervention might have a positive effect on symptom management.",2020,"Post-hoc analysis revealed a significant effect in MVPA (14.3 mins/day; 95% CI: 2.3, 26.3) and pain (","['people with inflammatory arthritis', 'People with Inflammatory Arthritis', 'people with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE', '118 participants enrolled']","['Physical Activity Counselling Program', 'education and counselling by a physiotherapist (PT), used a Fitbit and a web-application to obtain feedback about their physical activity, and received 4 follow-up calls from the PT', 'multi-faceted counselling intervention']","['pain ', 'time spent in moderate/vigorous physical activity (MVPA; in bouts of ≥10 mins) measured with a SenseWear', 'MVPA', 'step count, time in sedentary behaviour, pain, fatigue, mood, self-management capacity, and habitual behaviours', 'perceived walking habit', 'pain', 'physical activity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",118.0,0.374587,"Post-hoc analysis revealed a significant effect in MVPA (14.3 mins/day; 95% CI: 2.3, 26.3) and pain (","[{'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'University of British Columbia, Vancouver, and Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Feehan', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Arthritis Research Canada, Richmond, and Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Arthritis Research Canada, Richmond, and Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Shaw', 'Affiliation': 'Simon Fraser University, Surrey, British Columbia, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gromala', 'Affiliation': 'Simon Fraser University, Surrey, British Columbia, Canada.'}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Aviña-Zubieta', 'Affiliation': 'University of British Columbia, Vancouver, and Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Koehn', 'Affiliation': 'Arthritis Consumer Experts, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Hoens', 'Affiliation': 'University of British Columbia, Vancouver, and Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'English', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Tam', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Therrien', 'Affiliation': 'Arthritis Research Canada, Richmond, British Columbia, Canada.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Townsend', 'Affiliation': ""University of Exeter, St Luke's Campus, Exeter, UK.""}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Noonan', 'Affiliation': 'Vancouver General Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Backman', 'Affiliation': 'University of British Columbia, Vancouver, and Arthritis Research Canada, Richmond, British Columbia, Canada.'}]",Arthritis care & research,['10.1002/acr.24199']
278,31795041,Improved emotion regulation after neurofeedback: A single-arm trial in patients with borderline personality disorder.,"Real-time functional magnetic resonance imaging (fMRI) neurofeedback training of amygdala hemodynamic activity directly targets a neurobiological mechanism, which contributes to emotion regulation problems in borderline personality disorder (BPD). However, it remains unknown which outcome measures can assess changes in emotion regulation and affective instability, associated with amygdala downregulation in a clinical trial. The current study directly addresses this question. Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback. Before and after the training, as well as at a six-weeks follow-up assessment, participants completed measures of emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI). Participants were able to downregulate their amygdala blood oxygen-dependent (BOLD) response with neurofeedback. There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training. Further explorative analyses suggest that patients indicated less affective instability, as seen by lower hour-to-hour variability in negative affect and inner tension in daily life. If replicated by an independent study, our results imply changes in emotion regulation and affective instability for several systems levels, including behavior and verbal report. Conclusions are limited due to the lack of a control group. A randomized controlled trial (RCT) will be needed to confirm effectiveness of the training.",2019,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"['patients with borderline personality disorder', 'borderline personality disorder (BPD', 'Twenty-four female patients with a DSM-IV BPD diagnosis underwent four runs of amygdala neurofeedback']",[],"['emotion-modulated startle to negative pictures', 'emotion regulation and affective instability', 'amygdala blood oxygen-dependent (BOLD) response with neurofeedback', 'affective instability', 'emotion dysregulation and affective instability at diverse levels of analysis (verbal report, clinical interview, ecological momentary assessment, emotion-modulated startle, heart rate variability, and fMRI', 'emotion regulation', 'Zanarini rating scale for BPD (ZAN-BPD', 'BPD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0443264', 'cui_str': 'Modulated (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1444783', 'cui_str': 'Instability'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0460109', 'cui_str': 'Verbal report'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",24.0,0.0423346,There was a decrease of BPD symptoms as assessed with the Zanarini rating scale for BPD (ZAN-BPD) and a decrease in emotion-modulated startle to negative pictures after training.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zaehringer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany. Electronic address: jenny.zaehringer@zi-mannheim.de.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Ende', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Santangelo', 'Affiliation': 'Chair of Applied Psychology/Mental Health Lab, Institute of Sport and Sports Science, Karlsruhe Institute of Technology, Karlsruhe, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Kleindienst', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Ruf', 'Affiliation': 'Department Neuroimaging, Central Institute of Mental Health, Medical Faculty Mannheim / University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Bertsch', 'Affiliation': 'Department for General Psychiatry, Center of Psychosocial Medicine, University of Heidelberg, Heidelberg, Germany; Department of Psychology, LMU Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychiatric and Psychosomatic Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmahl', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Paret', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Mannheim, Germany; Sagol Brain Institute, Wohl Institute for Advanced Imaging, Tel-Aviv Sourasky Medical Center and School of Psychological Sciences, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: christian.paret@zi-mannheim.de.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102032']
279,32049551,Validation of Spanish version of the human papilloma virus impact profile (HIP).,"Objective: To examine the construct validity and reliability of the Spanish version of the HPV Impact Profile scale (HIP) among women in Medellin, Colombia. Methods: We conducted a nested analysis of data from the pragmatic randomized controlled trial ""Evaluation of Strategies for Optimal Clinical Management of Women with Atypical Squamous Cells of Undetermined Significance"" (ASCUS-COL; NCT02067468). Women with Atypical Squamous Cells of Undetermined Significance (ASCUS) were randomly assigned to one of three triage strategies (Pap smear, colposcopy, HPV). Participants completed a questionnaire with sociodemographic information and the HIP scale translated into Spanish at baseline, two weeks after receiving triage test results, and one year after the second questionnaire. We conducted exploratory and confirmatory factorial analysis, and then assessed test reliability using Cronbach's alpha. Subsequently, we conducted multigroup confirmatory factor analysis to assess differences according to women´s age, and configurational invariance of the factor structure over the three time measures. Results: The sample consisted of 675 women, with a mean age of 40 years. The exploratory and confirmatory factor analysis for the HIP showed a seven-factor structure with appropriate adjustment indicators ([Formula: see text]= 1466.783, p < .0001). Only two items (1 and 10) had low factor loads and were removed from the confirmatory analysis. Multigroup analysis according to women's age showed acceptable goodness of fit (RMSEA = 0.037, CFI/TLI:0.998/0.998). The factor structure was similar among the tree measures and the model preserved acceptable goodness of fit (RMSEA = 0.079, CFI:0.86). The Cronbach's alpha for the total score was 0.91, with the lowest score for sexual impact (0.49) and the highest score for worries and concerns (0.90). Conclusions: The Spanish version of the HIP had adequate reliability and construct validity, and its use could be considered in clinic and research settings.",2020,"The Spanish version of the HIP had adequate reliability and construct validity, and its use could be considered in clinic and research settings.","['Women with Atypical Squamous Cells of Undetermined Significance (ASCUS', '675 women, with a mean age of 40 years', 'women in Medellin, Colombia', 'Women with Atypical Squamous Cells of Undetermined Significance"" (ASCUS-COL']",[],"['low factor loads', 'HPV Impact Profile scale (HIP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0521184', 'cui_str': 'ASCUS'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C4521397', 'cui_str': 'US Military Commissioned Officer O6'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]",675.0,0.107363,"The Spanish version of the HIP had adequate reliability and construct validity, and its use could be considered in clinic and research settings.","[{'ForeName': 'Alexandra Restrepo', 'Initials': 'AR', 'LastName': 'Henao', 'Affiliation': 'Epidemiology Department, Columbia University, New York, NY, USA.'}, {'ForeName': 'Nilton Edu Montoya', 'Initials': 'NEM', 'LastName': 'Gómez', 'Affiliation': 'Statistical Applications and Public Health group, National School of Public Health, Universidad of Antioquia, Medellın, Colombia.'}, {'ForeName': 'Difariney', 'Initials': 'D', 'LastName': 'Gonzalez-Gómez', 'Affiliation': 'Demography and Health Group, National School of Public Health, Universidad of Antioquia, Medellın, Colombia.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Garcés-Palacio', 'Affiliation': 'Epidemiology Group, National School of Public Health, Universidad of Antioquia, Medellın, Colombia.'}]",Current medical research and opinion,['10.1080/03007995.2020.1729709']
280,32059936,"The Effect of Transendocardial Stem Cell Injection on Erectile Function in Men With Cardiomyopathy: Results From the TRIDENT, POSEIDON, and TAC-HFT Trials.","BACKGROUND
Despite limited human data, there is a growing interest in the use of stem cell therapy (SCT) for erectile dysfunction (ED).
AIM
To determine the effect of transendocardial stem cell injection on erectile function on men with cardiomyopathy and ED.
METHODS
We used International Index of Erectile Function (IIEF) scores collected from men enrolled in 3 separate randomized controlled trials: Comparison of Allogeneic vs Autologous Bone Marrow-Derived Mesenchymal Stem Cells Delivered by Transendocardial Injection in Patients With Ischemic Cardiomyopathy (POSEIDON), Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells for Ischemic Cardiomyopathy (TAC-HFT), and Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (TRIDENT). These trials recruited patients with ischemic cardiomyopathy and ejection fraction less than 50%. Inclusion and exclusion criteria were identical in all 3 trials. The primary intervention in these trials included transendocardial stem cell injection of stem cells or placebo via cardiac catheterization. The follow-up period was 1 year. IIEF data were collected at baseline and at multiple time points in each trial.
OUTCOMES
We investigated erectile function over time based on cell dose, cell source (autologous vs allogenic), cell type (mesenchymal stem cells vs bone marrow mononuclear cells), and comparing men who received SCT with those who received placebo.
RESULTS
A total of 36 men were identified with complete IIEF data. 8 men received placebo injection, and 28 received SCT. The median age was 66.5 years. Comorbidities were similar among all men. Analysis was performed on men with ED, defined by an IIEF-EF score of 24 or less. In the placebo and all-comer SCT group, the median IIEF-EF score was 5 [1-8] and 5 [1-15] at baseline and was 3.5 [3-5.8] and 7 [1-18] at 12 months (P > .05). When analyzed by cell dose, the IIEF-EF score in men who received 200 million cells increased significantly over 12 months (14 [4-23] to 20 [15-24.5], P = .014.) Similarly, an autologous cell source resulted in a similar increase from baseline to 12 months (14 [3.8-23.3] to 20 [12-22], P = .030).
CLINICAL IMPLICATIONS
Erectile function may improve after systemic delivery of SCT in men with ischemic cardiomyopathy and at least mild ED.
STRENGTHS & LIMITATIONS
This post hoc analysis is the first to investigate the effect of SCT on erectile function using randomized, placebo-controlled data. Weaknesses include that ED was not a primary end point, and men were not originally recruited based on erectile function.
CONCLUSION
Future trials on systemic delivery of SCT for ED should focus on high cell dose and autologous cell source, as these seem to provide the best response in men with at least mild ED. Ory J, Saltzman RG, Blachman-Braun R, et al. The Effect of Transendocardial Stem Cell Injection on Erectile Function in Men With Cardiomyopathy: Results From the TRIDENT, POSEIDON, and TAC-HFT Trials. J Sex Med 2020;17:695-701.",2020,"When analyzed by cell dose, the IIEF-EF score in men who received 200 million cells increased significantly over 12 months (14 [4-23] to 20 [15-24.5], P = .014.)","['men with cardiomyopathy and ED', 'Patients', 'men with at least mild ED', 'men with ischemic cardiomyopathy and at least mild ED', 'Men With Cardiomyopathy', 'patients with ischemic cardiomyopathy and ejection fraction less than 50', 'A total of 36 men were identified with complete IIEF data']","['transendocardial stem cell injection of stem cells or placebo via cardiac catheterization', 'transendocardial stem cell injection', 'stem cell therapy (SCT', 'SCT', 'Transendocardial Stem Cell Injection', 'placebo', 'Allogeneic vs Autologous Bone Marrow-Derived Mesenchymal Stem Cells Delivered by Transendocardial Injection', 'Allogeneic Mesenchymal Stem Cells', 'cell source (autologous vs allogenic), cell type (mesenchymal stem cells vs bone marrow mononuclear cells', 'placebo injection', 'Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells']","['Erectile Function', 'Erectile Function (IIEF) scores', 'IIEF-EF score', 'erectile function', 'median IIEF-EF score', 'IIEF data']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0005955', 'cui_str': 'Bone Marrow Cells'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",36.0,0.430963,"When analyzed by cell dose, the IIEF-EF score in men who received 200 million cells increased significantly over 12 months (14 [4-23] to 20 [15-24.5], P = .014.)","[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Ory', 'Affiliation': 'Department of Urology, Dalhousie University, Halifax, NS, Canada; Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Russell G', 'Initials': 'RG', 'LastName': 'Saltzman', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Blachman-Braun', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dadoun', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Darcy L', 'Initials': 'DL', 'LastName': 'DiFede', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Premer', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hurwitz', 'Affiliation': 'Behavioral Medicine Research Center, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Ranjith', 'Initials': 'R', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA; Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA. Electronic address: ramasamy@miami.edu.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.01.003']
281,30013913,Which of the branched-chain amino acids increases cerebral blood flow in hepatic encephalopathy? A double-blind randomized trial.,"Branched-chain amino acids increase the brain perfusion of patients with hepatic encephalopathy (HE), but the amino acid and the mechanisms involved are still unknown. This study compared brain perfusion and clinical improvement during leucine or isoleucine supplementation. After randomization, 27 subjects with cirrhosis and HE received leucine or isoleucine supplements for one year. Brain single Photon Emission Computed Tomography (SPECT) and dynamic brain scintigraphy (DBS) were performed pretreatment and at 1, 8 and 12 months of supplementation. Brain perfusion was increased only in the isoleucine group at 8 months of treatment by both SPECT and DBS ( p < 0.001 and p = 0.05, respectively) and by SPECT at the 12th month ( p < 0.05). This was associated with hepatic encephalopathy improvement at 8 and 12 months ( p = 0.008 and 0.004, respectively), which was not observed in the leucine group ( p = 0.313 and 0.055, respectively). Isoleucine supplementation achieved a better impact on brain perfusion restoration in HE.",2018,"This was associated with hepatic encephalopathy improvement at 8 and 12 months ( p = 0.008 and 0.004, respectively), which was not observed in the leucine group ( p = 0.313 and 0.055, respectively).","['27 subjects with cirrhosis and HE received', 'patients with hepatic encephalopathy (HE']","['branched-chain amino acids', 'Branched-chain amino acids', 'Isoleucine supplementation', 'leucine or isoleucine supplements', 'leucine or isoleucine supplementation', 'Brain single Photon Emission Computed Tomography (SPECT) and dynamic brain scintigraphy (DBS']","['brain perfusion', 'hepatic encephalopathy improvement', 'cerebral blood flow', 'Brain perfusion', 'brain perfusion restoration']","[{'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}]","[{'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0022192', 'cui_str': 'L-isoleucine'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}]",27.0,0.368642,"This was associated with hepatic encephalopathy improvement at 8 and 12 months ( p = 0.008 and 0.004, respectively), which was not observed in the leucine group ( p = 0.313 and 0.055, respectively).","[{'ForeName': 'Fernando Gomes', 'Initials': 'FG', 'LastName': 'Romeiro', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: fgromeiro@fmb.unesp.br.'}, {'ForeName': 'Marjorie do Val', 'Initials': 'MDV', 'LastName': 'Ietsugu', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Letícia de Campos', 'Initials': 'LC', 'LastName': 'Franzoni', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Laís', 'Initials': 'L', 'LastName': 'Augusti', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Alvarez', 'Affiliation': 'Department of Physics and Biophysics, Botucatu Biosciences Institute, UNESP - Univ Estadual Paulista, Rua Prof. Dr. Antonio Celso Wagner Zanin, s/n, Botucatu, São Paulo 18618-689, Brazil. Electronic address: matheus@consult.med.br.'}, {'ForeName': 'Lívia Alves Amaral', 'Initials': 'LAA', 'LastName': 'Santos', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Talles Bazeia', 'Initials': 'TB', 'LastName': 'Lima', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Kátia Hiromoto', 'Initials': 'KH', 'LastName': 'Koga', 'Affiliation': 'Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n. Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: khkoga@fmb.unesp.br.'}, {'ForeName': 'Sônia Marta', 'Initials': 'SM', 'LastName': 'Moriguchi', 'Affiliation': 'Department of Tropical Diseases and Imaging Diagnosis, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n. Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Carlos Antonio', 'Initials': 'CA', 'LastName': 'Caramori', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil.'}, {'ForeName': 'Giovanni Faria', 'Initials': 'GF', 'LastName': 'Silva', 'Affiliation': 'Department of Internal Medicine, Botucatu Medical School, UNESP - Univ Estadual Paulista. Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: giovanni@fmb.unesp.br.'}, {'ForeName': 'Luiz Eduardo Gomes Garcia', 'Initials': 'LEGG', 'LastName': 'Betting', 'Affiliation': 'Department of Neurology, Psychology and Psychiatry, Botucatu Medical School, UNESP - Univ Estadual Paulista, Av. Prof. Mário Rubens Guimarães Montenegro, s/n Distrito de Rubião Jr, Botucatu, São Paulo 18618-687, Brazil. Electronic address: betting@fmb.unesp.br.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2018.03.028']
282,31951747,A randomized study on the usefulness of an electronic outpatient hypoglycemia risk calculator for clinicians of patients with diabetes in a safety-net institution.,"Objective: Hypoglycemia (HG) occurs in up to 60% of patients with diabetes mellitus (DM) each year. We assessed a HG alert tool in an electronic health record system, and determined its effect on clinical practice and outcomes. Methods: The tool applied a statistical model, yielding patient-specific information about HG risk. We randomized outpatient primary-care providers (PCPs) to see or not see the alerts. Patients were assigned to study group according to the first PCP seen during four months. We assessed prescriptions, testing, and HG. Variables were compared by multinomial, logistic, or linear model. ClinicalTrials.gov ID: NCT04177147 (registered on 22 November 2019). Results: Patients ( N = 3350) visited 123 intervention PCPs; 3395 patients visited 220 control PCPs. Intervention PCPs were shown 18,645 alerts (mean of 152 per PCP). Patients' mean age was 55 years, with 61% female, 49% black, and 49% Medicaid recipients. Mean baseline A1c and body mass index were similar between groups. During follow-up, the number of A1c and glucose tests, and number of new, refilled, changed, or discontinued insulin prescriptions, were highest for patients with highest risk. Per 100 patients on average, the intervention group had fewer sulfonylurea refills (6 vs. 8; p < .05) and outpatient encounters (470 vs. 502; p < .05), though the change in encounters was not significant. Frequency of HG events was unchanged. Conclusions: Informing PCPs about risk of HG led to fewer sulfonylurea refills and visits. Longer-term studies are needed to assess potential for long-term benefits.",2020,"Per 100 patients on average, the intervention group had significantly fewer sulfonylurea refills (6 versus 8; p < 0.05) and outpatient encounters (470 versus 502; p < 0.05), though the change in encounters was not significant.","['3350 patients visited 123 intervention PCPs; 3395 patients visited 220 control PCPs', 'Adult patients', ""Patients' mean age was 55 years, with 61% female, 49% black, and 49% Medicaid recipients"", 'patients with diabetes in a safety-net institution']",['electronic outpatient hypoglycemia risk calculator'],"['sulfonylurea refills', 'number of A1c and glucose tests and number of new, refilled, changed, or discontinued insulin prescriptions', 'Hypoglycemia (HG', 'body mass index', 'Frequency of A1c testing and HG events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0870240', 'cui_str': 'Calculator'}]","[{'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",3350.0,0.0618134,"Per 100 patients on average, the intervention group had significantly fewer sulfonylurea refills (6 versus 8; p < 0.05) and outpatient encounters (470 versus 502; p < 0.05), though the change in encounters was not significant.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiner', 'Affiliation': 'Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cummins', 'Affiliation': 'Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Ofner', 'Affiliation': 'Department of Biostatistics, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Iglay', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Teal', 'Affiliation': 'Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Engel', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Knapp', 'Affiliation': 'Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Rajpathak', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Jarod', 'Initials': 'J', 'LastName': 'Baker', 'Affiliation': 'Regenstrief Institute, Inc, Indianapolis, IN, USA.'}, {'ForeName': 'Arnaub K', 'Initials': 'AK', 'LastName': 'Chatterjee', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Radican', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1717451']
283,31957691,"Effects of working memory training on cognitive, affective, and biological responses to stress in major depression: A novel cognitive bias modification protocol.","BACKGROUND
Over 320 million individuals are living with Major Depressive Disorder (MDD), a leading cause of disability worldwide. Thus, there is a crucial need to identify processes that contribute to the maintenance of depressive episodes. Difficulty removing negative information from working memory (WM) is posited to exacerbate affective, cognitive, and biological dysregulation in Major Depressive Disorder (MDD), but this has not yet been tested empirically.
METHODS
In this study we examined whether training depressed individuals to remove negative information from WM (RNI training) would reduce symptoms of depression and levels of rumination, and would be associated with attenuated biological responsivity to stress. Individuals diagnosed with MDD were randomly assigned to complete Real-RNI training or Sham-RNI training for six days.
RESULTS
Across conditions, participants exhibited significant improvements from pre- to post-training in removing negative information from WM, symptoms of depression, and rumination. Furthermore, participants in the Real-RNI condition showed a more attenuated pattern of cortisol and respiratory sinus arrhythmia (RSA) responses to stress than did participants in the Sham-RNI training condition.
LIMITATIONS
We did not assess the long-term effects of training. It will be important for future research to examine whether the documented training-related effects persist across time.
CONCLUSIONS
This study is the first to examine the effects of RNI training on clinical symptoms and biological responses to stress in MDD, and it provides experimental evidence that training individuals with depression to remove negative information from WM can help to modulate the heightened biological responses to stress seen in depression.",2020,"Across conditions, participants exhibited significant improvements from pre- to post-training in removing negative information from WM, symptoms of depression, and rumination.","['320 million individuals are living with Major Depressive Disorder (MDD', 'Individuals diagnosed with MDD', 'major depression']","['training depressed individuals to remove negative information from WM (RNI training', 'complete Real-RNI training or Sham-RNI training', 'working memory training', 'RNI training']","['cognitive, affective, and biological responses', 'WM, symptoms of depression, and rumination', 'pattern of cortisol and respiratory sinus arrhythmia (RSA) responses to stress']","[{'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C3812870', 'cui_str': 'Respiratory Sinus Arrhythmia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0349911,"Across conditions, participants exhibited significant improvements from pre- to post-training in removing negative information from WM, symptoms of depression, and rumination.","[{'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Jopling', 'Affiliation': 'Department of Psychology, University of British Columbia, 2136 West Mall, Vancouver, BC V6T1Z4, Canada. Electronic address: ellen.jopling@psych.ubc.ca.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Gotlib', 'Affiliation': 'Stanford University, USA.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'LeMoult', 'Affiliation': 'Department of Psychology, University of British Columbia, 2136 West Mall, Vancouver, BC V6T1Z4, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.007']
284,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z']
285,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y']
286,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3']
287,31764105,Association between HIV antiretroviral therapy and preterm birth based on antenatal ultrasound gestational age determination: a comparative analysis.,"OBJECTIVE
To evaluate the association between HIV antiretroviral therapy (ART) and preterm birth (PTB), when defined by gold standard antenatal ultrasound versus newborn exam.
DESIGN
A secondary analysis of the PROMISE 1077BF/1077FF randomized controlled trial, which compared antiretroviral strategies to reduce perinatal HIV transmission and improve maternal health. The trial used newborn exam (i.e. New Ballard Score, NBS) to assess gestational age. This analysis included liveborn singleton pregnancies with both newborn exam and ultrasound data. The primary exposure was the trial's antiretroviral strategies: zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART'). The primary outcome was PTB less than 37 and less than 34 weeks based on the gold standard of ultrasound dating. We evaluated the association between antiretroviral strategy and PTB. We fit multivariable logistic regression models, adjusting for maternal characteristics, obstetric history, and HIV disease severity.
RESULTS
Among 720 assessed pregnant women, PTB less than 37 weeks was 15.4% by NBS and 18.3% by ultrasound. The NBS was specific but not sensitive for PTB less than 37 weeks (92.0% and 48.5%). Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks. These results held for ultrasounds performed less than 24 weeks, and were generally consistent with prior analyses from the PROMISE trial using the NBS.
CONCLUSION
Women starting HIV ART in pregnancy remained at higher risk of PTB when determined by ultrasound, consistent with prior data using newborn exam. However, newborn exam misclassified cases of PTB compared with gold standard ultrasound.",2019,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.",['liveborn singleton pregnancies with both newborn exam and ultrasound data'],"['HIV antiretroviral therapy (ART) and preterm birth (PTB', 'ZDV', ""zidovudine with intrapartum nevirapine ('ZDV alone'); zidovudine/lamivudine/lopinavir-ritonavir ('ZDV-based ART'); or tenofovir/emtricitabine/lopinavir-ritonavir ('TDF-based ART""]",['perinatal HIV transmission and improve maternal health'],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum (qualifier value)'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",720.0,0.198607,"Women receiving ZDV-based and TDF-based ART had significantly higher odds of PTB less than 37 by ultrasound compared with ZDV alone (adjusted odds ratios: 1.68; 95% confidence interval 1.10-2.57, and 2.71; 95% confidence interval 1.39-5.29), as well as for PTB less than 34 weeks.","[{'ForeName': 'Kartik Kailas', 'Initials': 'KK', 'LastName': 'Venkatesh', 'Affiliation': ""aDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina bHarvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, Massachusetts, USA cCentre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa dByramiee Jeejeebhoy Government Medical College, Pune, India eMakerere University, Kampala, Uganda fWits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa gDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland hDivision of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.""}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': ''}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': ''}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': ''}, {'ForeName': 'Clemensia', 'Initials': 'C', 'LastName': 'Nakabiito', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': ''}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': ''}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': ''}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002367']
288,31787421,Assessing treatment efficacy by examining relationships between age groups of children with autism spectrum disorder and clinical anxiety symptoms: Prediction by correspondence analysis.,"INTRODUCTION
Autism spectrum disorders (ASD) are neurodevelopmental in nature and are frequently accompanied by anxiety. To fully assess treatment efficacy, we examined rates of anxiety symptom change by age groups following either cognitive behavioral therapy (CBT) or treatment as usual (TAU).
METHODS
One hundred sixty-three children with ASD and ASD-related anxiety symptoms were randomly assigned to either CBT or TAU. Utilizing prediction by correspondence analysis (CA), we evaluated the age effect (defined in three groups; ages 6-9, 10-12, and 13-16) and the changes in correlations between age and anxiety severity levels over the course of treatment.
RESULTS
Significantly greater anxiety symptom reduction was associated with CBT compared with TAU across the three age groups. Of particular note, the children ages 10-12 who received CBT showed the greatest improvement compared to all other groups. Late childhood, prior to adolescence, showed the best response to CBT for anxiety in ASD.
DISCUSSION
These findings suggest that treatment programs need to more closely address developmental factors within narrower bands of age groups. The present results are limited in their generalization to the CBT efficacy for a specific age band (ages 10-12). Longitudinal investigations are recommended to confirm whether the similar age group children who receive CBT experience the greatest benefit in reducing their ASD-related anxiety symptoms.",2020,Significantly greater anxiety symptom reduction was associated with CBT compared with TAU across the three age groups.,"['One hundred sixty-three children with ASD and ASD-related anxiety symptoms', 'children with autism spectrum disorder and clinical anxiety symptoms']","['CBT or TAU', 'cognitive behavioral therapy (CBT) or treatment as usual (TAU', 'CBT']","['anxiety symptom change', 'anxiety symptom reduction']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",163.0,0.012788,Significantly greater anxiety symptom reduction was associated with CBT compared with TAU across the three age groups.,"[{'ForeName': 'Se-Kang', 'Initials': 'SK', 'LastName': 'Kim', 'Affiliation': 'Fordham University, New York City, NY, United States. Electronic address: sekim@fordham.edu.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McKay', 'Affiliation': 'Fordham University, New York City, NY, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Ehrenreich-May', 'Affiliation': 'University of Miami, Coral Gables, FL, United States.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'University of California, Los Angeles, CA, United States.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Baylor College of Medicine, Houston, TX, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.107']
289,31795035,Stability of frontal alpha asymmetry in depressed patients during antidepressant treatment.,"INTRODUCTION
Frontal alpha asymmetry (FAA) is a proposed prognostic biomarker in major depressive disorder (MDD), conventionally acquired with electroencephalography (EEG). Although small studies attributed trait-like properties to FAA, a larger sample is needed to reliably asses this characteristic. Furthermore, to use FAA to predict treatment response, determining its stability, including the potential dependency on depressive state or medication, is essential.
METHODS
In the international Study to Predict Optimized Treatment in Depression (iSPOT-D), a multi-center, randomized, prospective open-label trial, 1008 MDD participants were randomized to treatment with escitalopram, sertraline or venlafaxine-extended release. Treatment response was established eight weeks after treatment initiation and resting state EEG was measured both at baseline and after eight weeks (n = 453).
RESULTS
FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity. After randomizing females to escitalopram or sertraline, for whom treatment response could be predicted in an earlier study, FAA after eight weeks resulted in equivalent response prediction as baseline FAA (one tailed p = .028).
CONCLUSION
We demonstrate that FAA is a stable trait, robust to time, state and pharmacological status. This confirms FAA stability. Furthermore, as prediction of treatment response is irrespective of moment of measurement and use of medication, FAA can be used as a state-invariant prognostic biomarker with promise to optimize MDD treatments.",2019,"RESULTS
FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","['1008 MDD participants', 'depressed patients during antidepressant treatment']","['escitalopram, sertraline or venlafaxine-extended release', 'FAA', 'Frontal alpha asymmetry (FAA', 'sertraline']","['resting state EEG', 'Stability of frontal alpha asymmetry']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",1008.0,0.02721,"RESULTS
FAA did not change significantly after eight weeks of treatment (n = 453, p = .234), nor did we find associations with age, sex, depression severity, or change in depression severity.","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'van der Vinne', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Synaeda Psycho Medisch Centrum, Leeuwarden, The Netherlands; Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands. Electronic address: n.van.der.vinne@synaeda.nl.'}, {'ForeName': 'Madelon A', 'Initials': 'MA', 'LastName': 'Vollebregt', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Michel J A M', 'Initials': 'MJAM', 'LastName': 'van Putten', 'Affiliation': 'Department of Clinical Neurophysiology, Technical Medical Centre, University of Twente, Enschede, The Netherlands; Department of Clinical Neurophysiology and Neurology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Arns', 'Affiliation': 'Research Institute Brainclinics, Nijmegen, The Netherlands; Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.102056']
290,32250337,Effects of EMG-triggered FES during trunk pattern in PNF on balance and gait performance in persons with stroke.,"BACKGROUND
EMG-triggered functional electrical stimulation (EMG-triggered FES) is one of the effective method for improving task performance and providing movement re-learning of central nervous system. Proprioceptive neuromuscular facilitation (PNF) is a traditional manual therapy that is used as a method to regain normal movement by providing specific training methods.
OBJECTIVE
The purpose of this study was to investigate the effect of EMG-triggered FES during trunk pattern in PNF on trunk control, balance, and gait of stroke patients.
METHODS
Forty participants were randomly allocated to EMG-triggered FES during PNF trunk pattern group (n = 20) and PNF trunk pattern group (n = 20). This study was a pretest-posttest with a control group design for duration of 4weeks (30 min/5 times/1 week). Outcome measures involved trunk impairment scale (TIS), Berg balance scale (BBS), and dynamic gait index (DGI).
RESULTS
In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention. However, there was no significant difference between the two groups in the comparison of the experimental group and the control group according to the amount of change before and after the training.
CONCLUSIONS
The results of this study showed that PNF trunk pattern affected the trunk control for stroke patients, and increased trunk control ability was effective in improving balance and walking. In addition, it was found that the EMG-triggered FES applied to the PNF trunk pattern affected the trunk control.",2020,"In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention.","['persons with stroke', 'Forty participants']","['EMG-triggered FES', 'Proprioceptive neuromuscular facilitation (PNF', 'EMG-triggered FES during PNF trunk pattern group (n\u200a=\u200a20) and PNF trunk pattern group', 'EMG-triggered functional electrical stimulation (EMG-triggered FES']","['trunk control ability', 'balance and gait performance', 'trunk impairment scale (TIS), Berg balance scale (BBS), and dynamic gait index (DGI', 'TIS, BBS, and DGI score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0525959', 'cui_str': '16-fluoroestradiol, (16alpha, 17beta)-isomer, (18F)-labeled'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index'}, {'cui': 'C0475413', 'cui_str': 'Tis category'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0195031,"In the experimental group and control group, TIS, BBS, and DGI score was significantly increased after intervention.","[{'ForeName': 'Jaehong', 'Initials': 'J', 'LastName': 'Shim', 'Affiliation': 'Department of Physical Therapy, ROI Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Physical Therapy, Baekseok University, Chungcheongnam-do, Republic of Korea.'}, {'ForeName': 'Kyongil', 'Initials': 'K', 'LastName': 'Ki', 'Affiliation': 'Department of Physical Therapy, Walkrun Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Jeonju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190944']
291,32248403,The assessment of dermatological emergencies in the emergency department via telemedicine is safe: a prospective pilot study.,"The aim of the study was to examine the feasibility and safety of telemedicine for dermatological emergency patients in the emergency department. This observational study was monocentric, open, prospective and two-arm randomized [control group (n = 50) and teledermatology group (n = 50)]. The control group was conventionally recruited directly by a dermatologist. In the teledermatology group patients, images of the skin lesions and clinical parameters were transferred to a tablet PC (personal computer) by an emergency physician and telemedically assessed by a dermatologist without patient contact. Subsequently, the dermatologist, who was previously telemedically contacted, then personally examined the patient in the emergency department. The treatment time between the control group and the teledermatology group was also recorded and compared. The agreement in suspected diagnosis between teledermatological evaluation and clinical evaluation of the same physician in the teledermatology group was 100%. The treatment time [mean (minutes) ± standard deviation] of the control group was 151 ± 71, that of the teledermatology group was 43 ± 38 (p < 0.001). The use of emergency telemedicine is safe and effective and provides a viable alternative for clinical care of emergency patients.",2020,"The treatment time [mean (minutes) ± standard deviation] of the control group was 151 ± 71, that of the teledermatology group was 43 ± 38 (p < 0.001).","['emergency patients', 'dermatological emergency patients in the emergency department']","['telemedicine', 'emergency telemedicine']","['treatment time [mean (minutes)\u2009±\u2009standard deviation', 'feasibility and safety']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0172014,"The treatment time [mean (minutes) ± standard deviation] of the control group was 151 ± 71, that of the teledermatology group was 43 ± 38 (p < 0.001).","[{'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Villa', 'Affiliation': 'Emergency Department, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Matz', 'Affiliation': 'Emergency Department, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany. omatz@ukaachen.de.'}, {'ForeName': 'Karmele', 'Initials': 'K', 'LastName': 'Olaciregui Dague', 'Affiliation': 'Department of Neurology, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kluwig', 'Affiliation': 'Department of Dermatology and Allergology, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Rossaint', 'Affiliation': 'Department of Anaesthesiology, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}, {'ForeName': 'Jörg Christian', 'Initials': 'JC', 'LastName': 'Brokmann', 'Affiliation': 'Emergency Department, University Hospital, Rheinisch-Westfälische Technische Hochschule [RWTH] Aachen, Aachen, Germany.'}]",Internal and emergency medicine,['10.1007/s11739-020-02323-1']
292,31865758,Real-world outcomes of treatment with insulin glargine 300 U/mL versus standard-of-care in people with uncontrolled type 2 diabetes mellitus.,"Objective: To compare real-world outcomes with newer (insulin glargine 300 U/mL; Gla-300) versus standard of care (SoC) basal insulins (BIs) in the REACH (insulin-naïve; NCT02967224) and REGAIN (basal insulin-treated; NCT02967211) studies in participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil. Methods: In these open-label, parallel-group, pragmatic studies, patients (HbA 1c > 7.0%) were randomized to Gla-300 or SoC BI for a 6-month treatment period (to demonstrate non-inferiority of Gla-300 vs SoC BIs for HbA 1c change [non-inferiority margin 0.3%]) and a 6-month extension period (continuing with their assigned treatment). Insulin titration/other medication changes were at investigator/patient discretion post-randomization. Results: Overall, 703 patients were randomized to treatment in REACH (Gla-300, n = 352; SoC, n = 351) and 609 (Gla-300, n = 305, SoC, n = 304) in REGAIN. The primary outcome, non-inferiority of Gla-300 versus SoC for HbA 1c change from baseline to month 6, was met in REACH (least squares [LS] mean difference 0.12% [95% CI -0.046 to 0.281]) but not REGAIN (LS mean difference 0.17% [0.015-0.329]); no between-treatment difference in HbA 1c change was shown after 12 months in either study. BI dose increased minimally from baseline to 12 months in REACH (Gla-300, +0.17 U/kg; SoC, +0.15 U/kg) and REGAIN (Gla-300, +0.11 U/kg; SoC, +0.07 U/kg). Hypoglycemia incidence was low and similar between treatment arms in both studies. Conclusions: In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs were seen over 12 months. However, the suboptimal insulin titration in REACH and REGAIN limits comparisons of outcomes between treatment arms and suggests that more titration instruction/support may be required for patients to fully derive the benefits from newer basal insulin formulations.",2020,"In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs was seen over 12 months.","['people with uncontrolled type 2 diabetes mellitus', 'participants with uncontrolled type 2 diabetes (T2DM) in Europe and Brazil', '703 patients']","['insulin glargine 300\u2009U/mL versus standard-of-care', '300\u2009U/mL; Gla-300', 'newer (insulin glargine', 'Gla-300 or SoC BI']","['glycemic control or hypoglycemia outcomes', 'Hypoglycemia incidence', 'non-inferiority of Gla-300 versus SoC for HbA 1c change']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",703.0,0.0684961,"In both REACH and REGAIN, no differences in glycemic control or hypoglycemia outcomes with Gla-300 versus SoC BIs was seen over 12 months.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Didac', 'Initials': 'D', 'LastName': 'Mauricio', 'Affiliation': 'Department of Endocrinology & Nutrition, Hospital de la Santa Creu i Sant Pau, CIBERDEM, Barcelona, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Center for Endocrine and Metabolic Diseases, Fondazione Policlinico Universitario A. Gemelli IRCSS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Bailey', 'Affiliation': 'AMCR Institute, Escondido, CA, USA.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Roussel', 'Affiliation': 'Department of Diabetology, Endocrinology, and Nutrition, Bichat Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Franco', 'Affiliation': 'CPCLIN Clinical Research Center, São Paulo, Brazil.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Berthou', 'Affiliation': 'IT&M Stats, Paris, France.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Pilorget', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Westerbacka', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Bosnyak', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Bonnemaire', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Anna M G', 'Initials': 'AMG', 'LastName': 'Cali', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'My-Liên', 'Initials': 'ML', 'LastName': 'Nguyên-Pascal', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Penfornis', 'Affiliation': 'Department of Diabetes, Sud-Francilien Hospital, Corbeil-Essonnes and Université Paris Sud, Paris, France.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Perez-Maraver', 'Affiliation': ""Servei d´Endocrinologia i Nutrició, Hospital Universitari Bellvitge, L'Hospitalet de Llobregat, IDIBELL, Barcelona, Spain.""}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Seufert', 'Affiliation': 'Faculty of Medicine, Division of Endocrinology and Diabetology, Department of Medicine II, University Hospital of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Sullivan', 'Affiliation': 'The CHOICE Institute, School of Pharmacy, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Clinical Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Wysham', 'Affiliation': 'Diabetes and Endocrinology Center, Multicare Rockwood Clinic, Spokane, WA, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, Leicester General Hospital, University of Leicester, Leicester, UK.'}]",Current medical research and opinion,['10.1080/03007995.2019.1708287']
293,32247649,Pharmacodynamic effects of vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis in infrequent cannabis users.,"INTRODUCTION
The use and availability of oral and inhalable products containing cannabidiol (CBD) as the principal constituent has increased with expanded cannabis/hemp legalization. However, few controlled clinical laboratory studies have evaluated the pharmacodynamic effects of oral or vaporized CBD or CBD-dominant cannabis.
METHODS
Eighteen healthy adults (9 men; 9 women) completed four, double-blind, double-dummy, drug administration sessions. Sessions were separated by ≥1 week and included self-administration of 100 mg oral CBD, 100 mg vaporized CBD, vaporized CBD-dominant cannabis (100 mg CBD; 3.7 mg THC), and placebo. Study outcomes included: subjective drug effects, vital signs, cognitive/psychomotor performance, and whole blood THC and CBD concentrations.
RESULTS
Vaporized CBD and CBD-dominant cannabis increased ratings on several subjective items (e.g., Like Drug Effect) relative to placebo. Subjective effects did not differ between oral CBD and placebo and were generally higher for CBD-dominant cannabis compared to vaporized CBD. CBD did not increase ratings for several items typically associated with acute cannabis/THC exposure (e.g., Paranoid). Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use. CBD-dominant cannabis increased heart rate compared to placebo. Cognitive/psychomotor impairment was not observed in any drug condition.
CONCLUSIONS
Vaporized CBD and CBD-dominant cannabis produced discriminable subjective drug effects, which were sometimes stronger in women, but did not produce cognitive/psychomotor impairment. Subjective effects of oral CBD did not differ from placebo. Future research should further elucidate the subjective effects of various types of CBD products (e.g., inhaled, oral, topical), which appear to be distinct from THC-dominant products.",2020,Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use.,"['infrequent cannabis users', 'Eighteen healthy adults (9 men; 9 women']","['placebo', 'oral CBD', 'oral and inhalable products containing cannabidiol (CBD', 'CBD', 'vaporized and oral cannabidiol (CBD) and vaporized CBD-dominant cannabis', 'oral CBD, 100 mg vaporized CBD, vaporized CBD-dominant cannabis (100 mg CBD; 3.7 mg THC), and placebo']","['several subjective items', 'Subjective effects', 'Cognitive/psychomotor impairment', 'subjective drug effects, vital signs, cognitive/psychomotor performance, and whole blood THC and CBD concentrations', 'CBD-dominant cannabis', 'heart rate']","[{'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0424230', 'cui_str': 'Motor retardation'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",18.0,0.0867755,Women reported qualitatively higher ratings for Pleasant Drug Effect than men after vaporized CBD and CBD-dominant cannabis use.,"[{'ForeName': 'Tory R', 'Initials': 'TR', 'LastName': 'Spindle', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA. Electronic address: tspindle@jhmi.edu.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Cone', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Elia', 'Initials': 'E', 'LastName': 'Goffi', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Weerts', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., NC, 27709, USA.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Winecker', 'Affiliation': 'RTI International, Research Triangle Park, 3040 East Cornwallis Rd., NC, 27709, USA.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Bigelow', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Flegel', 'Affiliation': 'Substance Abuse and Mental Health Services Administration (SAMHSA), Division of Workplace Programs (DWP), 5600Fishers Lane, Rockville, MD, 20857, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vandrey', 'Affiliation': 'Behavioral Pharmacology Research Unit, Johns Hopkins University School of Medicine, 5510 Nathan Shock Dr., Baltimore, MD, 21224, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107937']
294,32007430,The Role of the Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Radical Prostatectomy: A Randomized Clinical Trial.,"BACKGROUND
Erectile dysfunction (ED) after radical prostatectomy (RP) still represents a major issue. Considering the benefits recently described regarding the application of low-intensity extracorporeal shockwave therapy (LiESWT) in vasculogenic ED, questions arise about its role in the scenario of penile rehabilitation.
AIM
To compare the early introduction of phosphodiesterase-5 inhibitor (PDE5i) with a combination therapy enrolling both early PDE5i use and LiESWT in patients submitted to RP.
METHODS
This study is a randomized clinical trial, open-label, with 2 parallel arms and an allocation ratio of 1:1. The study was registered in ReBEC (ensaiosclinicos.gov.br) Trial: RBR-85HGCG. Both arms started tadalafil at a dose of 5 mg/day right after the removal of the transurethral catheter, and the experimental group received 2,400 shocks/session-week distributed on 4 different penile regions. The full treatment consisted of 19,200 impulses across 8 weeks.
OUTCOMES
The primary clincal end point was ≥4-point difference favoring the experimental group considering the mean International Index of Erectile Function short form (IIEF-5) at last follow-up. Any statistical difference in the IIEF-5 score between the arms was stated as the primary statistical end point.
RESULTS
Between September 25, 2017, and December 3, 2018, 92 men were enrolled in the study. At last follow-up, we assessed 77 patients, 41 in the control group and 36 in the intervention group. A difference between groups was detected when accessing the final median IIEF-5 score (12.0 vs 10.0; P = .006). However, the primary clinical endpoint considering a difference ≥4-point between the arms has not been reached. When performing an exploratory analysis comparing the proportion of those individuals with an IIEF-5 score ≥17, no difference between groups was noted (17.1% vs 22.2%; P = .57).
CLINICAL IMPLICATIONS
So far, the benefits arising from LiESWT for penile rehabilitation after RP have been uncertain.
STRENGTHS & LIMITATIONS
This is the first trial assessing the role of LiESWT on erectile function after RP. Our study protocol included only one session per week for the experimental group, raising a query if a more intensive application could achieve better results once a statistically significant difference was found between groups. We discontinue the PDE5i use at the last session, which may have interfered in the penile vascular rehabilitation, maybe compromising the results too.
CONCLUSION
After therapy with 19,200 impulses therapy across 8 weeks, we found an improvement of the IIEF-5 score, but it was not enough to be considered clinically significant. More studies are warranted before any recommendation on this topic. Baccaglini W, Pazeto CL, Corrêa Barros EA, et al. The Role of the Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Radical Prostatectomy: A Randomized Clinical Trial. J Sex Med 2020;17:688-694.",2020,The primary clincal end point was ≥4-point difference favoring the experimental group considering the mean International Index of Erectile Function short form (IIEF-5) at last follow-up.,"['77 patients, 41 in the control group and 36 in the intervention group', 'patients submitted to RP', '92 men were enrolled in the study', 'Between September 25, 2017, and December 3, 2018']","['radical prostatectomy (RP', 'phosphodiesterase-5 inhibitor (PDE5i', 'low-intensity extracorporeal shockwave therapy (LiESWT', 'LiESWT', 'Low-Intensity Extracorporeal Shockwave Therapy', 'tadalafil']","['final median IIEF-5 score', 'mean\xa0International Index of Erectile Function short form (IIEF-5', 'IIEF-5 score', 'Penile Rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",92.0,0.0809134,The primary clincal end point was ≥4-point difference favoring the experimental group considering the mean International Index of Erectile Function short form (IIEF-5) at last follow-up.,"[{'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Baccaglini', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil. Electronic address: wbaccaglini@gmail.com.'}, {'ForeName': 'Cristiano Linck', 'Initials': 'CL', 'LastName': 'Pazeto', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Eduardo Augusto', 'Initials': 'EA', 'LastName': 'Corrêa Barros', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Frederico', 'Initials': 'F', 'LastName': 'Timóteo', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Monteiro', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Raiff Yusser', 'Initials': 'RY', 'LastName': 'Saad Rached', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Navas', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Glina', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.12.024']
295,32147571,A randomized placebo-controlled trial of bupropion for Cancer-related fatigue: Study design and procedures.,"BACKGROUND
Cancer-related fatigue is a significant problem and is associated with poor quality of life. Behavioral interventions include exercise and cognitive-behavioral therapy, which survivors may be unwilling or unable to adopt. Pharmacologic interventions (e.g., selective serotonin reuptake inhibitors) have been disappointing. One potential therapy is the antidepressant bupropion, a norepinephrine-dopamine reuptake inhibitor that targets both inflammation and the hypothalamic-pituitary-adrenal axis. The current study is intended to provide a rigorous test of the efficacy and tolerability of bupropion for cancer-related fatigue.
METHODS
A randomized, double-blind, placebo-controlled trial will examine the effects of bupropion on cancer-related fatigue. The trial will be conducted nationwide through the University of Rochester Medical Center (URMC) National Cancer Institute Community Oncology Research Program (NCORP). Disease-free breast cancer survivors (n = 422) who completed chemotherapy and/or radiotherapy 12-60 months previously and report significant fatigue will be randomized 1:1 to receive bupropion (300 mg/day) or placebo. Outcomes will be assessed at baseline and the 12-week follow-up. The primary outcome, fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F). Secondary outcomes include quality of life, depression, and drug tolerability. Exploratory outcomes include cognition and symptomatology. Potential biological mechanisms and genetic moderators of cancer-related fatigue will also be explored.
DISCUSSION
This study is the first placebo-controlled trial to our knowledge to evaluate bupropion for cancer-related fatigue. Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.",2020,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","['Disease-free breast cancer survivors (n\xa0=\xa0422) who completed', 'Cancer-related fatigue', 'University of Rochester Medical Center (URMC']","['bupropion', 'placebo', 'chemotherapy', 'Behavioral interventions include exercise and cognitive-behavioral therapy']","['efficacy and tolerability', 'cognition and symptomatology', 'fatigue, will be measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F', 'cancer-related fatigue', 'quality of life, depression, and drug tolerability']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",422.0,0.134713,"Positive results could revolutionize the treatment of cancer-related fatigue, as bupropion is safe, inexpensive, widely-available, and may be more tolerable and acceptable for many patients than current, limited treatment options.","[{'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA. Electronic address: heather.jim@moffitt.org.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Hyo Sook', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Heckler', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Janelsins', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Williams', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Julienne', 'Initials': 'J', 'LastName': 'Bower', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cole', 'Affiliation': 'University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Zeruesenay', 'Initials': 'Z', 'LastName': 'Desta', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Margarita Bobonis', 'Initials': 'MB', 'LastName': 'Babilonia', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Morrow', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Peppone', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105976']
296,32193729,Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing.,"HIV partner-testing (PT) may represent a unique and empowering HIV prevention strategy for groups that face structural and institutional barriers to HIV testing and care, including transgender women. We report on in-depth interviews (IDIs) with N = 10 transgender women who used HIV self-test kits for three months to screen potential sexual partners in a randomized controlled trial (iSUM; ""I'll Show You Mine"") that took place in New York City and San Juan, Puerto Rico. Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months). We conducted IDIs with the first N = 10 transgender women to enroll in the intervention group after three months in the study (after participants used kits with partners) to understand their experiences. Themes discussed in IDIs included: partners' reaction to HIV testing, participants' reactions to partners' test results or refusal to test, partners' own reaction to their test results, and decision-making around test use. Data were independently analyzed by two coders. Overwhelmingly, participants' experiences with PT was positive. Participants reported kits were convenient and acceptable to most partners. Transgender women felt that PT could pose additional risk for them; one woman experienced violence related to kit use. Furthermore, the availability of kits appeared to encourage participants and their partners to think about their HIV status and, in some cases, modify sexual behavior. Work suggests that HIV PT could be a viable risk-reduction strategy for transgender women.",2020,Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months).,"['10 transgender women who used HIV self-test kits for three months to screen potential sexual partners', ""Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing""]",['HIV partner-testing (PT'],[],"[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",[],10.0,0.0227863,Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months).,"[{'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA. Cr2857@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Catherine Cruz', 'Initials': 'CC', 'LastName': 'Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, School of Medicine, Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02829-x']
297,32245717,Surgical Inpatient's Attitudes Toward Resident Participation: All About Expectations.,"OBJECTIVE
Determine whether an educational video can improve surgical inpatients' attitudes toward resident participation in their care.
METHODS
Patients admitted to the Trauma/Emergency General Surgery Service at University Hospital (San Antonio, Texas) were randomly divided into control and intervention groups. Patients in the intervention group viewed a short educational video about the role and responsibilities of medical students, residents, and attending surgeons. All patients then completed a previously published survey.
RESULTS
A total of 140 patients responded to the survey (control = 81 and intervention = 59 patients). Overall, 86.4% of patients were welcoming of resident participation. Patients who were expecting residents to be involved in their care had attitudes that are more favorable on almost all survey questions regardless of their study condition. However, patients in the intervention group who expected resident involvement in their care had more favorable attitudes about senior residents (postgraduate year 3-5) assisting in routine or complicated surgery than those in the control group who were expecting resident involvement (both p ≤ 0.001). This same group of patients also had more favorable attitudes about surgical outcomes and overall surgical health when residents are involved (p = 0.004, p = 0.001, respectively). Most patients (79%) said they had no residents previously involved in their care, or they were unsure if residents were previously involved.
CONCLUSIONS
Patient expectation of resident involvement is one of the most important factors influencing perceptions of inpatients about resident participation in surgery. Our goal should be early and frequent discussion with patients about resident involvement in order to foster an atmosphere of trust, including full transparency regarding resident involvement in surgical procedures. An educational video may help introduce the roles of trainees and attending surgeons but should not be used in lieu of direct discussion with patients.",2020,Patients who were expecting residents to be involved in their care had attitudes that are more favorable on almost all survey questions regardless of their study condition.,"['Patients admitted to the Trauma/Emergency General Surgery Service at University Hospital (San Antonio, Texas', 'Most patients (79%) said they had no residents previously involved in their care, or they were unsure if residents were previously involved', 'Patients who were expecting residents to be involved in their care had attitudes that are more favorable on almost all survey questions regardless of their study condition', '140 patients responded to the survey (control\u202f=\u202f81 and intervention\u202f=\u202f59 patients', ""surgical inpatients' attitudes toward resident participation in their care""]","['short educational video', 'educational video']","['favorable attitudes about surgical outcomes and overall surgical health', 'favorable attitudes about senior residents (postgraduate year 3-5) assisting in routine or complicated surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0080151', 'cui_str': 'Simian AIDS'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",140.0,0.0177817,Patients who were expecting residents to be involved in their care had attitudes that are more favorable on almost all survey questions regardless of their study condition.,"[{'ForeName': 'Katherine G', 'Initials': 'KG', 'LastName': 'Beale', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Kempenich', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas. Electronic address: kempenich@uthscsa.edu.'}, {'ForeName': 'Ross E', 'Initials': 'RE', 'LastName': 'Willis', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Mohammed J', 'Initials': 'MJ', 'LastName': 'Al Fayyadh', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Reed', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Paccione', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Ebeling', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Haisar E', 'Initials': 'HE', 'LastName': 'Dao Campi', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Dent', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.02.025']
298,32245746,Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial.,"OBJECTIVE
To determine the effects of dapagliflozin in patients with heart failure (HF) and type 2 diabetes mellitus (T2DM) on left ventricular (LV) remodeling using cardiac MRI.
RESEARCH DESIGN AND METHODS
We randomized 56 patients with T2DM and HF with LV systolic dysfunction to dapagliflozin 10 mg daily or placebo for 1 year, on top of usual therapy. The primary end point was difference in LV end-systolic volume (LVESV) using cardiac MRI. Key secondary end points included other measures of LV remodeling and clinical and biochemical parameters.
RESULTS
In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling. However, it reduced diastolic blood pressure and loop diuretic requirements while increasing hemoglobin, hematocrit, and ketone bodies. There was a trend toward lower weight.
CONCLUSIONS
We were unable to determine with certainty whether dapagliflozin in patients with T2DM and HF had any effect on LV remodeling. Whether the benefits of dapagliflozin in HF are due to remodeling or other mechanisms remains unknown.",2020,"In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling.","['56 patients with T2DM and HF with LV systolic dysfunction to', 'patients with heart failure (HF) and type 2 diabetes mellitus (T2DM', 'Patients With Diabetes and Heart Failure']","['dapagliflozin 10 mg daily or placebo', 'Dapagliflozin Versus Placebo', 'dapagliflozin']","['diastolic blood pressure and loop diuretic requirements', 'lower weight', 'Left Ventricular Remodeling', 'LV remodeling', 'hemoglobin, hematocrit, and ketone bodies', 'LV end-systolic volume (LVESV) using cardiac MRI', 'LV remodeling and clinical and biochemical parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricular Remodeling'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0412692', 'cui_str': 'Cardiac MRI'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",56.0,0.196478,"In our cohort, dapagliflozin had no effect on LVESV or any other parameter of LV remodeling.","[{'ForeName': 'Jagdeep S S', 'Initials': 'JSS', 'LastName': 'Singh', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Ify R', 'Initials': 'IR', 'LastName': 'Mordi', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Keeran', 'Initials': 'K', 'LastName': 'Vickneson', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Mohapradeep', 'Initials': 'M', 'LastName': 'Mohan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Anna Maria J', 'Initials': 'AMJ', 'LastName': 'Choy', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gandy', 'Affiliation': 'Department of Medical Physics, NHS Tayside, Dundee, U.K.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Faisel', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Division of Population Health and Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'J Graeme', 'Initials': 'JG', 'LastName': 'Houston', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'Chim C', 'Initials': 'CC', 'LastName': 'Lang', 'Affiliation': 'Division of Molecular and Clinical Medicine, School of Medicine, University of Dundee, Dundee, U.K. c.c.lang@dundee.ac.uk.'}]",Diabetes care,['10.2337/dc19-2187']
299,32246748,"Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: A randomized, placebo-controlled trial on temporomandibular side-effects.","PURPOSE
To assess the differences in the frequency of clinical signs of temporomandibular disorder (TMD) pain and mandibular function impairment between mandibular advancement device (MAD) and nasal continuous positive airway pressure (nCPAP) therapies in obstructive sleep apnea (OSA) patients at baseline and after 6 month of treatment.
METHODS
This study concerns a secondary analysis of a randomized placebo-controlled trial in which different treatment effects of an objectively titrated MAD were compared with those of nCPAP and an intra-oral placebo appliance in a parallel design. Sixty-four mild to severe OSA patients (52.0 ± 9.6 years) were randomly assigned to these three groups. All patients underwent a shortened functional examination of their masticatory system at baseline and after 6 months to establish the presence of clinical signs of TMD pain. Mandibular function impairment was assessed with a questionnaire.
RESULTS
Clinical signs of TMD pain were only rarely present at baseline and therapy evaluation. No significant differences were found between the three groups in the (low) frequency of clinical signs of TMD pain at both time points (p = .401-.176). In addition, the (low) scores of mandibular function impairment did not differ between the three groups either, neither at baseline (p = .744) nor after 6 months (p = .359).
CONCLUSIONS
A low frequency of clinical signs of TMD pain in mild to severe OSA patients was found after 6 months, regardless of treatment with MAD or nCPAP. In addition, no difference in mandibular function impairment was observed between the different treatment modalities.",2020,No significant differences were found between the three groups in the (low) frequency of clinical signs of TMD pain at both time points (p = .401-.176).,"['obstructive sleep apnea', 'mild to severe OSA patients', 'Sixty-four mild to severe OSA patients (52.0\u2009±\u20099.6\u2009years', 'obstructive sleep apnea (OSA) patients at baseline and after 6 month of treatment']","['placebo', 'nCPAP and an intra-oral placebo appliance', 'mandibular advancement device (MAD) and nasal continuous positive airway pressure (nCPAP) therapies', 'Oral appliance therapy versus nasal continuous positive airway pressure']","['TMD pain', 'mandibular function impairment', 'temporomandibular disorder (TMD) pain and mandibular function impairment', 'Mandibular function impairment', 'low) frequency of clinical signs of TMD pain']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",64.0,0.118151,No significant differences were found between the three groups in the (low) frequency of clinical signs of TMD pain at both time points (p = .401-.176).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Nikolopoulou', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre of Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ghizlane', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre of Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Ahlberg', 'Affiliation': 'Department of Oral and Maxillofacial Diseases, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Hans L', 'Initials': 'HL', 'LastName': 'Hamburger', 'Affiliation': 'Amsterdam Sleep Centre, Boerhaave Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'de Lange', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Amsterdam University Medical Centre and Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction, Academic Centre of Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Clinical and experimental dental research,['10.1002/cre2.288']
300,32216909,Low-Dose Alteplase During Primary Percutaneous Coronary Intervention According to Ischemic Time.,"BACKGROUND
Microvascular obstruction affects one-half of patients with ST-segment elevation myocardial infarction and confers an adverse prognosis.
OBJECTIVES
This study aimed to determine whether the efficacy and safety of a therapeutic strategy involving low-dose intracoronary alteplase infused early after coronary reperfusion associates with ischemic time.
METHODS
This study was conducted in a prospective, multicenter, parallel group, 1:1:1 randomized, dose-ranging trial in patients undergoing primary percutaneous coronary intervention. Ischemic time, defined as the time from symptom onset to coronary reperfusion, was a pre-specified subgroup of interest. Between March 17, 2016, and December 21, 2017, 440 patients, presenting with ST-segment elevation myocardial infarction within 6 h of symptom onset (<2 h, n = 107; ≥2 h but <4 h, n = 235; ≥4 h to 6 h, n = 98), were enrolled at 11 U.K. hospitals. Participants were randomly assigned to treatment with placebo (n = 151), alteplase 10 mg (n = 144), or alteplase 20 mg (n = 145). The primary outcome was the amount of microvascular obstruction (MVO) (percentage of left ventricular mass) quantified by cardiac magnetic resonance imaging at 2 to 7 days (available for 396 of 440).
RESULTS
Overall, there was no association between alteplase dose and the extent of MVO (p for trend = 0.128). However, in patients with an ischemic time ≥4 to 6 h, alteplase increased the mean extent of MVO compared with placebo: 1.14% (placebo) versus 3.11% (10 mg) versus 5.20% (20 mg); p = 0.009 for the trend. The interaction between ischemic time and alteplase dose was statistically significant (p = 0.018).
CONCLUSION
In patients presenting with ST-segment elevation myocardial infarction and an ischemic time ≥4 to 6 h, adjunctive treatment with low-dose intracoronary alteplase during primary percutaneous coronary intervention was associated with increased MVO. Intracoronary alteplase may be harmful for this subgroup. (A Trial of Low-Dose Adjunctive Alteplase During Primary PCI [T-TIME]; NCT02257294).",2020,"Overall, there was no association between alteplase dose and the extent of MVO (p for trend = 0.128).","['Between March 17, 2016, and December 21, 2017, 440 patients, presenting with ST-segment elevation myocardial infarction within 6\xa0h of symptom onset (<2\xa0h,\xa0n\xa0=\xa0107;\xa0≥2\xa0h but\xa0<4 h, n\xa0=\xa0235;\xa0≥4', 'patients undergoing primary percutaneous coronary intervention', 'patients presenting with ST-segment elevation myocardial infarction and an ischemic time\xa0≥4 to 6 h, adjunctive treatment with']","['low-dose intracoronary alteplase', 'alteplase 10\xa0mg (n\xa0=\xa0144), or alteplase 20\xa0mg', 'Percutaneous Coronary Intervention', 'Low-Dose Alteplase', 'placebo', 'Intracoronary alteplase', 'Low-Dose Adjunctive Alteplase', 'Primary PCI [T-TIME']","['efficacy and safety', 'Ischemic time', 'mean extent of MVO', 'amount of microvascular obstruction (MVO) (percentage of left ventricular mass) quantified by cardiac magnetic resonance imaging']","[{'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]",,0.154095,"Overall, there was no association between alteplase dose and the extent of MVO (p for trend = 0.128).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McCartney', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom; West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Maznyczka', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom; West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom; West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom; West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals National Health Service (NHS) Trust, Leeds, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Maredia', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schmitt', 'Affiliation': 'Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'University of Leicester and the National Institute for Health Research Leicester Biomedical Research Center, Leicester, United Kingdom.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fairbairn', 'Affiliation': 'Liverpool Heart and Chest Hospital NHS Foundation Trust, Liverpool, United Kingdom.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'McAlindon', 'Affiliation': 'New Cross Hospital, Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Tait', 'Affiliation': 'Department of Hematology, Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Orchard', 'Affiliation': 'West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Clydebank, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Corcoran', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Ford', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom; Department of Cardiology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Radjenovic', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Center, University of Glasgow, Glasgow, United Kingdom; West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Clydebank, United Kingdom. Electronic address: colin.berry@glasgow.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.01.041']
301,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
302,31912632,A placebo-controlled proof-of-concept study of alirocumab on postprandial lipids and vascular elasticity in insulin-treated patients with type 2 diabetes mellitus.,"AIM
Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular disease (CVD) linked to atherogenic dyslipidaemia and postprandial hyperlipidaemia. Alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, improves CVD risk by reducing the concentration of low-density lipoprotein-cholesterol (LDL-C). However, effects of PCK9 inhibitors on other aspects of diabetic dyslipidaemia, particularly in the postprandial situation, are less clear.
MATERIAL AND METHODS
Twelve male patients with T2DM on an intensive insulin regimen completed a 6-week randomized, double-blind, placebo-controlled, proof-of-concept study. Participants received three biweekly dosages of subcutaneous alirocumab (150 mg) or placebo. Before and after the intervention, fasting and postprandial triglyceride (TG) plasma levels, apolipoprotein (apo) B48, lipoprotein composition isolated by ultracentrifugation, vascular function and markers of inflammation were evaluated.
RESULTS
Alirocumab treatment reduced fasting plasma TG levels (between group median change -24.7%; P = 0.018) and fasting apoB48 serum levels (-35.9%; P = 0.039) compared with placebo. Alirocumab reduced the plasma TG area under the curve (AUC) (-26.4%; P = 0.006) and apoB48 AUC (-55.7%; P = 0.046), as well as plasma TG incremental AUC (-21.4%; P = 0.04) and apoB48 incremental AUC (-26.8%; P = 0.02). In addition, alirocumab reduced fasting and postprandial TG levels in very low-density lipoprotein (VLDL) and LDL. Alirocumab improved fasting pulse wave velocity, but no changes in postprandial markers of inflammation were observed.
CONCLUSIONS
In addition to the well-known LDL-C-reducing effects, 6 weeks of alirocumab treatment lowered both fasting and postprandial plasma TG levels by reducing the TG levels in VLDL and LDL and the concentration of intestinal remnants.",2020,"Alirocumab reduced the plasma TG area under the curve (AUC) (-26.43%; p=0.006) and apo B48 AUC (-55.7%; p=0.046), as well as plasma TG incremental AUC (-21.4%; p=0.04) and apo B48 incremental AUC (-26.8%; p=0.02).","['Twelve male patients with T2DM on intensive insulin regimen', 'Type 2 Diabetes Mellitus (T2DM', 'Insulin-treated patients with Type 2 Diabetes Mellitus']","['Placebo', 'PCK9 inhibitors', 'placebo', 'Alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor', 'Alirocumab', 'subcutaneous alirocumab']","['postprandial markers of inflammation', 'Postprandial Lipids and Vascular Elasticity', 'TG levels in VLDL and LDL and the concentration of intestinal remnants', 'plasma TG area under the curve (AUC', 'plasma TG incremental AUC', 'fasting pulse wave velocity', 'fasting and postprandial plasma TG levels', 'fasting and postprandial TG levels', 'fasting and postprandial triglyceride (TG) plasma levels, apolipoprotein (apo) B48, lipoprotein composition isolated by ultracentrifugation, vascular function and markers of inflammation', 'fasting plasma TG levels', 'fasting apo B48 serum levels']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0013764'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0103839', 'cui_str': 'Chylomicron Apo B'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0041609', 'cui_str': 'Ultracentrifugation'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",12.0,0.24793,"Alirocumab reduced the plasma TG area under the curve (AUC) (-26.43%; p=0.006) and apo B48 AUC (-55.7%; p=0.046), as well as plasma TG incremental AUC (-21.4%; p=0.04) and apo B48 incremental AUC (-26.8%; p=0.02).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Burggraaf', 'Affiliation': 'Department of Internal Medicine, Center for Diabetes and Vascular Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Nadine M C', 'Initials': 'NMC', 'LastName': 'Pouw', 'Affiliation': 'Department of Clinical Chemistry, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Salvador Fernández', 'Initials': 'SF', 'LastName': 'Arroyo', 'Affiliation': 'Departament de Medicina i Cirurgia, Unitat de Recerca Biomèdica, Universitat Rovira i Virgili, Tarragona, Spain.'}, {'ForeName': 'Leonie C', 'Initials': 'LC', 'LastName': 'van Vark-van der Zee', 'Affiliation': 'Department of Internal Medicine, Division of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Gert-Jan M', 'Initials': 'GM', 'LastName': 'van de Geijn', 'Affiliation': 'Department of Clinical Chemistry, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Birnie', 'Affiliation': 'Department of Statistics and Education, Franciscus Academy, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Huisbrink', 'Affiliation': 'Department of Pharmacy, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'van der Zwan', 'Affiliation': 'Department of Clinical Chemistry, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}, {'ForeName': 'Monique T', 'Initials': 'MT', 'LastName': 'Mulder', 'Affiliation': 'Department of Internal Medicine, Division of Pharmacology, Vascular and Metabolic Diseases, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Wouter W', 'Initials': 'WW', 'LastName': 'de Herder', 'Affiliation': 'Department of Internal Medicine, Section of Endocrinology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Manuel Castro', 'Initials': 'MC', 'LastName': 'Cabezas', 'Affiliation': 'Department of Internal Medicine, Center for Diabetes and Vascular Medicine, Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13960']
303,32050099,Eccentric versus conventional cycle training to improve muscle strength in advanced COPD: A randomized clinical trial.,"OBJECTIVES
To compare eccentric (ECC) and conventional concentric (CON) cycle training on quadriceps muscle strength in advanced COPD. Secondary objective was to assess functional capacity.
METHODS
A parallel-group, assessor-blind, randomized trial was conducted. Severe COPD patients were randomized to either an ECC (n = 13) or CON (n = 11) cycling program for 30-min, 3 times/week for 10 weeks. ECC group trained at ∼4-fold higher power than the CON group at similar relative heart rate intensity.
RESULTS
Isometric and isokinetic quadriceps peak torque improved after ECC but not CON; between group difference was significant for isometric peak muscle force (p < 0.05). Peak cycling power and endurance time increased in both groups (p < 0.05). Dyspnea at peak cycling power improved only after ECC training (p < 0.05). Sensory intensity ratings of dyspnea and leg fatigue were significantly lower (p < 0.05) during ECC compared with CON at equivalent relative heart rate intensities.
CONCLUSIONS
ECC could be an effective alternative and/or adjunct modality to pulmonary rehabilitation in severely ventilatory limited COPD patients.",2020,"RESULTS
Isometric and isokinetic quadriceps peak torque improved after ECC but not CON; between group difference was significant for isometric peak muscle force (p < 0.05).","['severely ventilatory limited COPD patients', 'Severe COPD patients', 'advanced COPD']","['CON', 'eccentric (ECC) and conventional concentric (CON) cycle training', 'ECC', 'Eccentric versus conventional cycle training']","['quadriceps muscle strength', 'Peak cycling power and endurance time', 'Isometric and isokinetic quadriceps peak torque', 'isometric peak muscle force', 'Dyspnea at peak cycling power', 'muscle strength', 'functional capacity', 'Sensory intensity ratings of dyspnea and leg fatigue']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.0960479,"RESULTS
Isometric and isokinetic quadriceps peak torque improved after ECC but not CON; between group difference was significant for isometric peak muscle force (p < 0.05).","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourbeau', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, Research Institute of the McGill University Health Centre, McGill University, Montréal, Québec, Canada. Electronic address: jean.bourbeau@mcgill.ca.'}, {'ForeName': 'Riany', 'Initials': 'R', 'LastName': 'De Sousa Sena', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, Research Institute of the McGill University Health Centre, McGill University, Montréal, Québec, Canada; Department of Physical Therapy, University of Fortaleza, Fortaleza, Brazil; Department of Physical Therapy, Federal University of Ceara, Fortaleza, Brazil.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Taivassalo', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Ruddy', 'Initials': 'R', 'LastName': 'Richard', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, University-Hospital (CHU), Hôpital G. Montpied, Clermont, Ferrand, France.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Jensen', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, Research Institute of the McGill University Health Centre, McGill University, Montréal, Québec, Canada; Department of Kinesiology and Physical Education, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Jacinthe', 'Initials': 'J', 'LastName': 'Baril', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, Research Institute of the McGill University Health Centre, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Danielle Soares', 'Initials': 'DS', 'LastName': 'Rocha Vieira', 'Affiliation': 'Physical Therapy Department, Federal University of Santa Catarina, Brazil.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Perrault', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, Research Institute of the McGill University Health Centre, McGill University, Montréal, Québec, Canada; Faculty of Health Sciences, University of Ottawa, Ottawa, Canada.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103414']
304,30630555,Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT for depression: phase II trial.,"BACKGROUND
Although cognitive-behavioural therapy (CBT) is an effective treatment for depression, less than half of patients achieve satisfactory symptom reduction during treatment. Targeting known psychopathological processes such as rumination may increase treatment efficacy. The aim of this study was to test whether adding group rumination-focused CBT (RFCBT) that explicitly targets rumination to routine medical management is superior to adding group CBT to routine medical management in treating major depression.
METHODS
A total of 131 outpatients with major depression were randomly allocated to 12 sessions group RFCBT v. group CBT, each in addition to routine medical management. The primary outcome was observer-rated symptoms of depression at the end of treatment measured on the Hamilton Rating Scale for Depression. Secondary outcomes were rumination at post-treatment and depressive symptoms at 6 months follow-up (Trial registered: NCT02278224).
RESULTS
RFCBT significantly improved observer-rated depressive symptoms (Cohen's d 0.38; 95% CI 0.03-0.73) relative to group CBT at post-treatment on the primary outcome. No post-treatment differences were found in rumination or in depressive symptoms at 6 months follow-up, although these secondary analyses may have been underpowered.
CONCLUSIONS
This is the first randomized controlled trial providing evidence of benefits of RFCBT in major depression compared with CBT. Group RFCBT may be a beneficial alternative to group CBT for major depression.",2020,"No post-treatment differences were found in rumination or in depressive symptoms at 6 months follow-up, although these secondary analyses may have been underpowered.
",['131 outpatients with major depression'],"['RFCBT v. group CBT', 'RFCBT', 'adding group rumination-focused CBT (RFCBT', 'cognitive-behavioural therapy (CBT', 'Group rumination-focused cognitive-behavioural therapy (CBT) v. group CBT']","['rumination or in depressive symptoms', 'rumination at post-treatment and depressive symptoms', 'observer-rated symptoms of depression', 'observer-rated depressive symptoms', 'Hamilton Rating Scale for Depression']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}]",131.0,0.107561,"No post-treatment differences were found in rumination or in depressive symptoms at 6 months follow-up, although these secondary analyses may have been underpowered.
","[{'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hvenegaard', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stine B', 'Initials': 'SB', 'LastName': 'Moeller', 'Affiliation': 'Psychiatric Research Unit, Mental Health Centre North Zealand, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Poulsen', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gondan', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Grafton', 'Affiliation': 'Cognition and Emotion Lab, School of Psychology, University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Austin', 'Affiliation': 'Psychiatric Research Unit, Mental Health Centre North Zealand, University of Copenhagen, Hillerød, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Kistrup', 'Affiliation': 'Psychiatric Outpatient Service, Mental Health Centre North Zealand, Hillerød, Denmark.'}, {'ForeName': 'Nicole G K', 'Initials': 'NGK', 'LastName': 'Rosenberg', 'Affiliation': 'Psychotherapeutic Clinic Nannasgade, Mental Health Centre Copenhagen, Capital Region Mental Health Services, Copenhagen, Denmark.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Howard', 'Affiliation': 'Mental Health Centre for Child and Adolescent Psychiatry, Glostrup, Denmark.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Watkins', 'Affiliation': 'Mood Disorders Centre, School of Psychology, University of Exeter, Exeter, UK.'}]",Psychological medicine,['10.1017/S0033291718003835']
305,31970881,"Relationship between hypoglycaemia, body mass index and quality of life among patients with type 1 diabetes: Observations from the DEPICT clinical trial programme.","AIMS
To demonstrate the relationships between hypoglycaemia, body mass index (BMI) and quality of life, and to examine the impact of dapagliflozin on patient-reported treatment satisfaction in patients with type 1 diabetes mellitus (T1DM), using data from the DEPICT (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes) clinical trial programme.
METHODS
A two-stage modelling approach, using a linear regression framework, was adopted to evaluate the relationship between hypoglycaemia, BMI and quality of life. Hypoglycaemia fear score (HFS) was modelled as a function of hypoglycaemic events (non-severe documented symptomatic and severe) and, subsequently, quality of life (as measured by the EQ-5D questionnaire) was modelled as a function of HFS and BMI. A linked evidence approach correlated the relationship between treatment, hypoglycaemic events and glycated haemoglobin (HbA1c), to the relationships captured within the regression models. The proportion of patients achieving increased patient-reported treatment satisfaction, as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) total score, was compared between study arms.
RESULTS
Incident severe hypoglycaemia was associated with significantly higher HFS (coefficient estimate [CE] 14.62, P=0.004). The frequency of symptomatic hypoglycaemic events was associated with a significantly higher HFS (log transposed, CE 1.32, P=0.026). Higher HFS and higher BMI were both independently associated with a significantly lower EQ-5D score (HFS: CE -0.0024, P<0.001; BMI: CE -0.0026, P=0.016). Significantly higher proportions of dapagliflozin-treated patients achieved ≥3-point increases in DTSQ total score compared to patients in the placebo group.
CONCLUSION
The results of this study demonstrated that increases in hypoglycaemia and BMI were associated with reduced quality of life in people with T1DM. Dapagliflozin-treated patients achieved a reduction in HbA1c whilst avoiding an increase in hypoglycaemic events. The results also showed that treatment with dapagliflozin was associated with an improvement in treatment satisfaction.",2020,Dapagliflozin-treated patients achieved a reduction in HbA1c whilst avoiding an increase in hypoglycaemic events.,"['patients with type 1 diabetes', 'patients with type 1 diabetes mellitus (T1DM']","['placebo', 'dapagliflozin', 'Dapagliflozin']","['Diabetes Treatment Satisfaction Questionnaire (DTSQ) total score', 'frequency of symptomatic hypoglycaemic events', 'hypoglycaemic events', 'hypoglycaemia and BMI', 'hypoglycaemia, BMI and quality of life', 'DTSQ total score', 'hypoglycaemia, body mass index and quality of life', 'Hypoglycaemia fear score (HFS', 'hypoglycaemia, body mass index (BMI) and quality of life', 'EQ-5D score', 'treatment satisfaction', 'quality of life', 'HFS', 'proportion of patients achieving increased patient-reported treatment satisfaction', 'Higher HFS and higher BMI', 'hypoglycaemic events and glycated haemoglobin (HbA1c']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0034380'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",,0.0455179,Dapagliflozin-treated patients achieved a reduction in HbA1c whilst avoiding an increase in hypoglycaemic events.,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Gordon', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Birmingham, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beresford-Hulme', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Birmingham, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Bennett', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK.'}, {'ForeName': 'Amarjeet', 'Initials': 'A', 'LastName': 'Tank', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'McEwan', 'Affiliation': 'Health Economics and Outcomes Research Ltd, Cardiff, UK.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13972']
306,31974063,Effect of a Simple Exercise Program on Hospitalization-Associated Disability in Older Patients: A Randomized Controlled Trial.,"OBJECTIVE
Hospitalization-associated disability [HAD, ie, the loss of ability to perform ≥1 basic activities of daily living (ADLs) independently at discharge] is a frequent condition among older patients. The present study assessed whether a simple inpatient exercise program decreases HAD incidence in acutely hospitalized very old patients.
DESIGN
In this randomized controlled trial (Activity in Geriatric Acute Care) participants were assigned to a control or intervention group and were assessed at baseline, admission, discharge, and 3 months thereafter.
SETTING AND PARTICIPANTS
In total, 268 patients (mean age 88 years, range 75-102) admitted to an acute care for older patients unit of a public hospital were randomized to a control (n = 125) or intervention (exercise) group (n = 143).
METHODS
Both groups received usual care, and patients in the intervention group also performed simple supervised exercises (walking and rising from a chair, for a total duration of ∼20 minutes/day). We measured ADL function (Katz index) and incident HAD at discharge and after 3 months (primary outcome) and Short Physical Performance Battery, ambulatory capacity, number of falls, rehospitalization, and death during a 3-month follow-up (secondary outcomes).
RESULTS
Median duration of hospitalization was 7 days (interquartile range 4 days). The intervention group had a lower risk of HAD with reference to both baseline [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17-0.76, P = .007] and admission (OR 0.29; 95% CI 0.10-0.89, P = .030). A trend toward an improved ADL function at discharge vs admission was found in the intervention group compared with controls (OR 0.32; 95% CI ‒0.04 to 0.68; P = .083). No between-group differences were noted for the other endpoints (all P > .05).
CONCLUSION AND IMPLICATIONS
A simple inpatient exercise program decreases risk of HAD in acutely hospitalized, very old patients.",2020,"The intervention group had a lower risk of HAD with reference to both baseline [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17-0.76, P = .007] and admission (OR 0.29; 95% CI 0.10-0.89, P = .030).","['acutely hospitalized, very old patients', 'Geriatric Acute Care) participants', 'older patients', 'acutely hospitalized very old patients', 'Older Patients', '268 patients (mean age 88\xa0years, range 75-102) admitted to an acute care for older patients\xa0unit of a public hospital']","['control (n\xa0=\xa0125) or intervention (exercise', 'inpatient exercise program', 'Simple Exercise Program', 'simple inpatient exercise program', 'usual care, and patients in the intervention group also performed simple supervised exercises (walking and rising from a chair']","['Median duration of hospitalization', 'Hospitalization-Associated Disability', 'ADL function', 'ADL function (Katz index) and incident HAD at discharge and after 3\xa0months (primary outcome) and Short Physical Performance Battery, ambulatory capacity, number of falls, rehospitalization, and death during a 3-month follow-up (secondary outcomes']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living (assessment scale)'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",268.0,0.146437,"The intervention group had a lower risk of HAD with reference to both baseline [odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17-0.76, P = .007] and admission (OR 0.29; 95% CI 0.10-0.89, P = .030).","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ortiz-Alonso', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain. Electronic address: javier.ortiz@salud.madrid.org.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Bustamante-Ara', 'Affiliation': 'Universidad Autónoma de Chile, Talca, Chile.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Systems Biology Department, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Vidán-Astiz', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; School of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rodríguez-Romo', 'Affiliation': 'Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; Sports Department, Instituto Nacional de Educación Física, Universidad Politécnica, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mayordomo-Cava', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Javier-González', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Hidalgo-Gamarra', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Myriel', 'Initials': 'M', 'LastName': 'Lopéz-Tatis', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Valades-Malagón', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Santos-Lozano', 'Affiliation': ""i+HeALTH, European University Miguel de Cervantes, Valladolid, Spain; Research Institute Hospital 12 de Octubre ('i+12'), Madrid, Spain.""}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': ""Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; Research Institute Hospital 12 de Octubre ('i+12'), Madrid, Spain; Faculty of Sport Sciences, Universidad Europea de Madrid, Madrid, Spain.""}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Serra-Rexach', 'Affiliation': 'Geriatric Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain; Biomedical Research Networking Center on Frailty and Healthy Aging, CIBERFES, Madrid, Spain; School of Medicine, Universidad Complutense, Madrid, Spain.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.11.027']
307,31838002,"Safety, efficacy, and pharmacokinetics of pradefovir for the treatment of chronic hepatitis B infection.","BACKGROUND & AIMS
Pradefovir is a liver targeted novel prodrug of adefovir (PMEA) developed to provide higher antiviral activity with reduced systemic toxicities. This study evaluated the tolerability, pharmacokinetics, and antiviral activity of pradefovir in patients with chronic hepatitis B (CHB) virus infection.
METHODS
Non-cirrhotic, treatment-naïve subjects with CHB were divided into five groups (10 patients each) and randomized within each group in a ratio of 6:2:2 to receive an ascending dose of 30, 60, 75, 90, or 120 mg pradefovir, 10 mg adefovir dipivoxil (ADV), or 300 mg tenofovir disoproxil fumarate (TDF) once a day for 28 days.
RESULTS
A total of 51 subjects were randomized and 49 subjects completed the study. The groups were well matched and included 39 males, of whom 71% were hepatitis B e-antigen-negative with a mean hepatitis B virus (HBV) DNA level of 6.4-7.16 log10 IU/mL. No subject experienced a serious adverse event or nephrotoxicity. The most frequently reported adverse event was asymptomatic reduction in blood cholinesterase levels in the pradefovir group which recovered without any treatment about 13 ± 7 days after drug discontinuation. This adverse event was not observed in the ADV and TDF groups. The mean changes in serum HBV DNA were -2.78, -2.77, -3.08, -3.18, -3.44, -2.34, and -3.07 log10 IU/mL at 30, 60, 75, 90, and 120 mg pradefovir, 10 mg ADV and 300 mg TDF, respectively, with plateau levels reached with 60 mg pradefovir. Pradefovir and its metabolite PMEA showed linear pharmacokinetics proportional to the dose. The half-life of PMEA in the pradefovir group was 11.47-17.63 h.
CONCLUSIONS
Short-term use of pradefovir was well tolerated. A decline in HBV DNA levels was superior to TDF at higher doses of pradefovir. 30-60 mg pradefovir is recommended for CHB treatment.
CLINICAL TRIAL NUMBER
CTR20150224.",2020,"The mean changes in serum HBV DNA were -2.78, -2.77, -3.08, -3.18, -3.44, -2.34, and -3.07 log10 IU/mL at 30, 60, 75, 90, and 120 mg pradefovir, 10 mg ADV and 300 mg TDF, respectively, with plateau levels reached with 60 mg pradefovir.","['chronic hepatitis B infection', '51 subjects were randomized and 49 subjects completed the study', 'The groups were well matched and included 39 males, of whom 71% were hepatitis B e-antigen-negative with a mean hepatitis B virus (HBV) DNA level of 6.4-7.16 log10 IU/mL', 'patients with chronic hepatitis B (CHB) virus infection', 'Non-cirrhotic, treatment-naïve subjects with CHB']","['pradefovir', 'pradefovir, 10\u202fmg adefovir dipivoxil (ADV), or 300\u202fmg tenofovir disoproxil fumarate (TDF']","['Safety, efficacy, and pharmacokinetics', 'mean changes in serum HBV DNA', 'HBV DNA levels', 'tolerated', 'blood cholinesterase levels', 'tolerability, pharmacokinetics, and antiviral activity of pradefovir', 'serious adverse event or nephrotoxicity']","[{'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0439458', 'cui_str': 'international unit/milliliter'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1692892', 'cui_str': 'pradefovir'}, {'cui': 'C0540694', 'cui_str': 'adefovir dipivoxil'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0853164', 'cui_str': 'Blood cholinesterase'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1692892', 'cui_str': 'pradefovir'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0599918', 'cui_str': 'Nephrotoxicity'}]",51.0,0.0469779,"The mean changes in serum HBV DNA were -2.78, -2.77, -3.08, -3.18, -3.44, -2.34, and -3.07 log10 IU/mL at 30, 60, 75, 90, and 120 mg pradefovir, 10 mg ADV and 300 mg TDF, respectively, with plateau levels reached with 60 mg pradefovir.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Jin', 'Affiliation': ""Xi'an Xintong Pharmaceutical Research Co., Ltd, China.""}, {'ForeName': 'Dengke', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Xintong Pharmaceutical Research Co., Ltd, China. Electronic address: dengkzhang@xtyw.com.cn.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Chengjiao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China. Electronic address: yanhuad2019@163.com.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Jilin, China. Electronic address: junqiniu@aliyun.com.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China. Electronic address: 174745978@qq.com.'}]",Antiviral research,['10.1016/j.antiviral.2019.104693']
308,32203696,"Quality of life after breast-conserving therapy and adjuvant radiotherapy for non-low-risk ductal carcinoma in situ (BIG 3-07/TROG 07.01): 2-year results of a randomised, controlled, phase 3 trial.","BACKGROUND
BIG 3-07/TROG 07.01 is an international, multicentre, randomised, controlled, phase 3 trial evaluating tumour bed boost and hypofractionation in patients with non-low-risk ductal carcinoma in situ following breast-conserving surgery and whole breast radiotherapy. Here, we report the effects of diagnosis and treatment on health-related quality of life (HRQOL) at 2 years.
METHODS
The BIG 3-07/TROG 07.01 trial is ongoing at 118 hospitals in 11 countries. Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ were randomly assigned, by use of a minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy using one of three randomisation categories. Category A was a 4-arm randomisation of tumour bed boost versus no boost following conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy (42·5 Gy in 16 fractions over 3·5 weeks). Category B was a 2-arm randomisation between tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy. Stratification factors were age at diagnosis, planned endocrine therapy, and treating centre. The primary endpoint, time to local recurrence, will be reported when participants have completed 5 years of follow-up. The HRQOL statistical analysis plan prespecified eight aspects of HRQOL, assessed by four questionnaires at baseline, end of treatment, and at 6, 12, and 24 months after radiotherapy: fatigue and physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question). For each of these measures, tumour bed boost was compared with no boost, and conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy, by use of generalised estimating equation models. Analyses were by intention to treat, with Hochberg adjustment for multiple testing. This trial is registered with ClinicalTrials.gov, NCT00470236.
FINDINGS
Between June 1, 2007, and Aug 14, 2013, 1208 women were enrolled and randomly assigned to receive no tumour bed boost (n=605) or tumour bed boost (n=603). 396 of 1208 women were assigned to category A: conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost (n=100). 447 were assigned to category B: conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost (n=224). 365 were assigned to category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost (n=183). All patients were followed up at 2 years for the HRQOL analysis. 1098 (91%) of 1208 patients received their allocated treatment, and most completed their scheduled HRQOL assessments (1147 [95%] of 1208 at baseline; 988 [87%] of 1141 at 2 years). Cosmetic status was worse with tumour bed boost than with no boost across all timepoints (difference 0·10 [95% CI 0·05-0·15], global p=0·00014, Hochberg-adjusted p=0·0016); at the end of treatment, the estimated difference between tumour bed boost and no boost was 0·13 (95% CI 0·06-0·20; p=0·00021), persisting at 24 months (0·13 [0·06-0·20]; p=0·00021). Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08 [95% CI 0·03-0·13], global p=0·0033, Hochberg adjusted p=0·045); the difference between tumour bed boost and no boost at the end of treatment was 0·08 (0·01 to 0·15, p=0·021), and did not persist at 24 months (0·04 [-0·03 to 0·11], p=0·29). None of the other six prespecified aspects of HRQOL differed significantly after adjustment for multiple testing. Conventional whole breast radiotherapy was associated with worse body image than hypofractionated whole breast radiotherapy at the end of treatment (difference -1·10 [95% CI -1·79 to -0·42], p=0·0016). No significant differences were reported in the other PROs between conventional whole breast radiotherapy compared with hypofractionated whole breast radiotherapy.
INTERPRETATION
Tumour bed boost was associated with persistent adverse effects on cosmetic status and arm and shoulder functional status, which might inform shared decision making while local recurrence analysis is pending.
FUNDING
National Health and Medical Research Council, Susan G Komen for the Cure, Breast Cancer Now, OncoSuisse, Dutch Cancer Society.",2020,Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08,"['Women aged 18 years or older with completely excised non-low-risk ductal carcinoma in situ', 'non-low-risk ductal carcinoma', '396 of 1208 women were assigned to category A', '118 hospitals in 11 countries', 'patients with non-low-risk ductal carcinoma', '1098 (91%) of 1208 patients', 'Between June 1, 2007, and Aug 14, 2013, 1208 women']","['minimisation algorithm, to tumour bed boost or no tumour bed boost, following conventional whole breast radiotherapy or hypofractionated whole breast radiotherapy', 'conventional whole breast radiotherapy with tumour bed boost (n=223) or no boost', 'conventional whole breast radiotherapy', 'conventional whole breast radiotherapy with tumour bed boost (n=100) or no boost (n=98), or to hypofractionated whole breast radiotherapy with tumour bed boost (n=98) or no boost', 'category C: hypofractionated whole breast radiotherapy with tumour bed boost (n=182) or no boost', 'Conventional whole breast radiotherapy', 'tumour bed boost versus no boost following conventional whole breast radiotherapy, and category C was a 2-arm randomisation between tumour bed boost versus no boost following hypofractionated whole breast radiotherapy', 'no tumour bed boost (n=605) or tumour bed boost', 'breast-conserving surgery and whole breast radiotherapy', 'conventional whole breast radiotherapy (50 Gy in 25 fractions over 5 weeks) versus hypofractionated whole breast radiotherapy', 'breast-conserving therapy and adjuvant radiotherapy']","['physical functioning (EORTC QLQ-C30); cosmetic status, breast-specific symptoms, arm and shoulder functional status (Breast Cancer Treatment Outcome Scale); body image and sexuality (Body Image Scale); and perceived risk of invasive breast cancer (Cancer Worry Scale and a study-specific question', 'Cosmetic status', 'HRQOL', 'health-related quality of life (HRQOL', 'shoulder function', 'time to local recurrence', 'Quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0007124', 'cui_str': 'Ductal Carcinoma In Situ'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0002045'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0457102', 'cui_str': 'Whole breast (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0917927', 'cui_str': 'Breast-Conserving Surgery'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}, {'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0085415'}, {'cui': 'C0222045'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0036915', 'cui_str': 'Sexuality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",1208.0,0.212892,Arm and shoulder function was also adversely affected by tumour bed boost across all timepoints (0·08,"[{'ForeName': 'Madeleine T', 'Initials': 'MT', 'LastName': 'King', 'Affiliation': 'Faculty of Science, School of Psychology, The University of Sydney, Sydney, NSW, Australia. Electronic address: madeleine.king@sydney.edu.au.'}, {'ForeName': 'Emma K', 'Initials': 'EK', 'LastName': 'Link', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Whelan', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Ivo A', 'Initials': 'IA', 'LastName': 'Olivotto', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kunkler', 'Affiliation': 'Edinburgh Cancer Research Centre, Institute of Genetic and Molecular Medicine, University of Edinburgh, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Antonia Helen', 'Initials': 'AH', 'LastName': 'Westenberg', 'Affiliation': 'Radiotherapiegroep Arnhem, Arnhem, The Netherlands.'}, {'ForeName': 'Guenther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Institute for Radiotherapy, Klinik Hirslanden, Zurich, Switzerland.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Schofield', 'Affiliation': 'Behavioural Sciences Unit, Department of Cancer Experiences Research, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, University of Melbourne, Parkville, VIC, Australia; Department of Psychology, and Iverson Health Innovation Research Institute, Swinburne University, Melbourne, VIC, Australia.'}, {'ForeName': 'Boon H', 'Initials': 'BH', 'LastName': 'Chua', 'Affiliation': 'University of New South Wales, UNSW Medicine, Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30085-1']
309,31944546,"Higher versus standard starting dose of insulin glargine 100 U/mL in overweight or obese Chinese patients with type 2 diabetes: Results of a multicentre, open-label, randomized controlled trial (BEYOND VII).","AIM
To determine the safety of a higher starting dose of basal insulin in overweight/obese patients with type 2 diabetes (T2D).
MATERIALS AND METHODS
This 16-week, randomized, multicentre, open-label trial enrolled adults with T2D (body mass index 25-40 kg/m 2 ) and suboptimal glycaemic control (glycated haemoglobin [HbA1c] 7.5-11.0% [58-97 mmol/mol] and fasting plasma glucose [FPG] >9.0 mmol/L) with two to three oral anti-hyperglycaemic drugs at 51 centres in China. Patients were randomized (1:1) to a higher (0.3 U/kg) or standard (0.2 U/kg) starting dose of insulin glargine 100 U/mL, which was then titrated to achieve a self-monitored fasting blood glucose (FBG) of 4.4 to 5.6 mmol/L. The primary endpoint was the percentage of patients with ≥1 episode of overall confirmed hypoglycaemia (≤3.9 mmol/L or severe).
RESULTS
At the end of study (n = 866), 11.0% patients treated with the 0.3 U/kg starting insulin dose experienced overall confirmed hypoglycaemia versus 8.6% of patients treated with 0.2 U/kg (estimated difference 2.1%, 95% confidence interval - 1.68, 5.89). The proportions of patients with symptomatic (9.8% vs 7.0%; P = 0.128) and nocturnal hypoglycaemia (2.7% vs 1.2%; P = 0.102) were similar in the two groups. There were no events of severe hypoglycaemia or FBG <3.0 mmol/L during the 16-week treatment, and achievement of HbA1c <7.0% (53 mmol/mol) (37.1% vs 37.1%) or FPG <5.6 mmol/L (15.9% vs 16.3%), <6.1 mmol/L (27.6% vs 26.1%), or < 7.0 mmol/L (48.8% vs 48.3%) without hypoglycaemia were comparable in the two groups. Moreover, the mean time was shorter (4.53, 3.95 and 2.74 weeks vs 5.51, 5.21 and 3.64 weeks) and number of titrations was lower (3.5, 3.0 and 2.0 vs 4.3, 4.0 and 2.8) to achieve self-monitored FBG targets of <5.6, <6.1 and <7.0 mmol/L in the higher versus the standard insulin dose group (all P < 0.01).
CONCLUSIONS
Among overweight/obese patients with T2D, a higher insulin starting dose was as safe as the standard starting dose, and self-monitored FBG targets were achieved earlier with the higher versus the standard dose.",2020,"Among overweight/obese patients with T2D, a higher insulin starting dose was as safe as the standard starting dose, and SM-FBG targets were achieved earlier with the higher versus standard dose.","['overweight/obese patients with T2D', 'adults with T2D (body mass index 25-40 kg/m 2 ) and suboptimal glycaemic control (HbA1c 7.5-11.0% and fasting plasma glucose [FPG] >9.0\u2009mmol/L) with 2-3 oral antihyperglycaemic drugs at 51 centres in China', 'overweight or obese Chinese patients with type 2 diabetes', 'overweight/obese patients with type 2 diabetes (T2D']","['insulin glargine', 'insulin glargine 100 U/mL', 'basal insulin']","['severe hypoglycaemia or fasting blood glucose', 'mean time', 'number of titrations', 'percentage of patients with ≥1 episode of overall confirmed hypoglycaemia', 'hypoglycaemia', 'nocturnal hypoglycaemia']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia (disorder)'}]",,0.183786,"Among overweight/obese patients with T2D, a higher insulin starting dose was as safe as the standard starting dose, and SM-FBG targets were achieved earlier with the higher versus standard dose.","[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Hailong', 'Initials': 'H', 'LastName': 'Wan', 'Affiliation': 'Department of Endocrinology, Panjin Central Hospital, Panjin, China.'}, {'ForeName': 'Binhong', 'Initials': 'B', 'LastName': 'Wen', 'Affiliation': ""Department of Endocrinology, People's Hospital of Liaoning Province, Liaoning, China.""}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Jinzhou Central Hospital, Jinzhou, China.'}, {'ForeName': 'Junfen', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Second Hospital of Shijiazhuang, Shijiazhuang, China.'}, {'ForeName': 'Rongwen', 'Initials': 'R', 'LastName': 'Bian', 'Affiliation': 'Department of Endocrinology and Metabolism, Jiangsu Province Institute of Geriatrics, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wuyan', 'Initials': 'W', 'LastName': 'Pang', 'Affiliation': 'Department of Endocrinology and Metabolism, Huaihe Hospital of Henan University, Kaifeng, Henan, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Endocrinology and Metabolism, Central Hospital Affiliated to Shenyang Medical College, Shenyang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Second Hospital of Chaoyang City, Chaoyang City, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Bian', 'Affiliation': ""Department of Endocrinology, Cangzhou People's Hospital, Cangzhou, China.""}, {'ForeName': 'Zhengnan', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology and Metabolism, Dalian Municipal Central Hospital Affiliated of Dalian Medical University, Dalian, Liaoning, China.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Condoleon', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Sanofi, Shanghai, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Sanofi, Shanghai, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Cui', 'Affiliation': 'Sanofi, Shanghai, China.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13967']
310,32034072,Rindopepimut with Bevacizumab for Patients with Relapsed EGFRvIII-Expressing Glioblastoma (ReACT): Results of a Double-Blind Randomized Phase II Trial.,"PURPOSE
Rindopepimut is a vaccine targeting the tumor-specific EGF driver mutation, EGFRvIII. The ReACT study investigated whether the addition of rindopepimut to standard bevacizumab improved outcome for patients with relapsed, EGFRvIII-positive glioblastoma.
PATIENTS AND METHODS
In this double-blind, randomized, phase II study (NCT01498328) conducted at 26 hospitals in the United States, bevacizumab-naïve patients with recurrent EGFRvIII-positive glioblastoma were randomized to receive rindopepimut or a control injection of keyhole limpet hemocyanin, each concurrent with bevacizumab. The primary endpoint was 6-month progression-free survival (PFS6) by central review with a one-sided significance of 0.2.
RESULTS
Between May 2012 and 2014, 73 patients were randomized (36 rindopepimut, 37 control). Rindopepimut toxicity included transient, low-grade local reactions. As primary endpoint, PFS6 was 28% (10/36) for rindopepimut compared with 16% (6/37) for control ( P = 0.12, one-sided). Secondary and exploratory endpoints also favored the rindopepimut group including a statistically significant survival advantage [HR, 0.53; 95% confidence interval (CI), 0.32-0.88; two-sided log-rank P = 0.01], a higher ORR [30% (9/30) vs. 18% (6/34; P = 0.38)], median duration of response [7.8 months (95% CI, 3.5-22.2) vs. 5.6 (95% CI, 3.7-7.4)], and ability to discontinue steroids for ≥6 months [33% (6/18) vs. 0% (0/19)]. Eighty percent of rindopepimut-treated patients achieved robust anti-EGFRvIII titers (≥1:12,800), which were associated with prolonged survival (HR = 0.17; 95% CI, 0.07-0.45; P < 0.0001).
CONCLUSIONS
Our randomized trial supports the potential for targeted immunotherapy among patients with GBM, but the therapeutic benefit requires validation due to the small sample size and potential heterogeneity of bevacizumab response among recurrent patients with GBM. See related commentary by Wick and Wagener, p. 1535 .",2020,"As primary endpoint, PFS6 was 28% (10/36) for rindopepimut compared with 16% (6/37) for control ( P = 0.12, one-sided).","['Between May 2012 and 2014, 73 patients were randomized (36 rindopepimut, 37 control', 'Patients with Relapsed EGFRvIII-Expressing Glioblastoma (ReACT', 'patients with relapsed, EGFRvIII-positive glioblastoma', 'patients with GBM', '26 hospitals in the United States, bevacizumab-naïve patients with recurrent EGFRvIII-positive glioblastoma', 'recurrent patients with GBM']","['Rindopepimut with Bevacizumab', 'rindopepimut to standard bevacizumab', 'Rindopepimut', 'rindopepimut or a control injection of keyhole limpet hemocyanin, each concurrent with bevacizumab']","['robust anti-EGFRvIII titers', 'survival advantage', 'median duration of response', '6-month progression-free survival (PFS6) by central review with a one-sided significance of 0.2', 'prolonged survival', 'higher ORR', 'PFS6', 'Rindopepimut toxicity included transient, low-grade local reactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3181262', 'cui_str': 'rindopepimut'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0915629', 'cui_str': 'EGFRvIII'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C3181262', 'cui_str': 'rindopepimut'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0064332', 'cui_str': 'KLH antigen'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0915629', 'cui_str': 'EGFRvIII'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3181262', 'cui_str': 'rindopepimut'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}]",73.0,0.506885,"As primary endpoint, PFS6 was 28% (10/36) for rindopepimut compared with 16% (6/37) for control ( P = 0.12, one-sided).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Reardon', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Desjardins', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Vredenburgh', 'Affiliation': 'Saint Francis Hospital and Medical Center, Hartford, Connecticut.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': ""O'Rourke"", 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Tran', 'Affiliation': 'Washington University, St. Louis, Missouri.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Fink', 'Affiliation': 'Baylor Research Institute, Dallas, Texas.'}, {'ForeName': 'Louis B', 'Initials': 'LB', 'LastName': 'Nabors', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Bota', 'Affiliation': 'UC Irvine Medical Center, Irvine, California.'}, {'ForeName': 'Rimas V', 'Initials': 'RV', 'LastName': 'Lukas', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Lynn S', 'Initials': 'LS', 'LastName': 'Ashby', 'Affiliation': 'Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'J Paul', 'Initials': 'JP', 'LastName': 'Duic', 'Affiliation': 'Department of Neurosciences, Winthrop University Hospital, Mineola, New York.'}, {'ForeName': 'Maciej M', 'Initials': 'MM', 'LastName': 'Mrugala', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Cruickshank', 'Affiliation': 'Scott Cruickshank and Associates, Santa Barbara, California.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vitale', 'Affiliation': 'Celldex Therapeutics, Inc., Hampton, New Jersey.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Celldex Therapeutics, Inc., Hampton, New Jersey.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Green', 'Affiliation': 'Celldex Therapeutics, Inc., Hampton, New Jersey.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Yellin', 'Affiliation': 'Celldex Therapeutics, Inc., Hampton, New Jersey.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Turner', 'Affiliation': 'Celldex Therapeutics, Inc., Hampton, New Jersey.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Keler', 'Affiliation': 'Celldex Therapeutics, Inc., Hampton, New Jersey.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Davis', 'Affiliation': 'Celldex Therapeutics, Inc., Hampton, New Jersey.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Sampson', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-1140']
311,31727676,"A Phase II, Prospective, Randomized, Multicenter, Open-Label Study of GX-188E, an HPV DNA Vaccine, in Patients with Cervical Intraepithelial Neoplasia 3.","PURPOSE
To determine the efficacy of the therapeutic DNA vaccine GX-188E for inducing regression of cervical intraepithelial neoplasia (CIN) 3.
PATIENTS AND METHODS
We conducted a prospective, randomized, multicenter, open-label, phase II clinical trial of GX-188E in CIN3 patients positive for human papillomavirus (HPV) type 16/18. The primary endpoint was to determine the histopathologic regression to ≤CIN1 at visit seven (V7; 20 weeks after the first GX-188E injection), and an extension study was pursued until visit 8 (V8; 36 weeks after the first GX-188E injection). HPV-sequencing analysis and an ex vivo IFNγ ELISpot assay were performed using the collected cervical biopsy and blood samples from patients.
RESULTS
In total, 72 patients were enrolled and underwent randomization. Of them, 64 patients were included in per-protocol analysis (V7) and 52 in extension analysis (V8). Our data showed 52% (33/64) of patients at V7 and 67% (35/52) of patients at V8 presented histopathologic regression after receiving the GX-188E injection. We found that 73% (V7) and 77% (V8) of the patients with histologic regression showed HPV clearance. HPV clearance and histopathologic regression were significantly associated at V7 and at V8. Compared with the measurements at V1 (baseline), the patients at V8 with HPV clearance showed significantly higher fold changes in their IFNγ ELISpot responses compared with those without HPV clearance. The HPV sequence analysis revealed that the HPV type 16 E6/E7 variants D25E, V83L, and N29S were inversely associated with histopathologic regression at V8.
CONCLUSIONS
GX-188E is an effective therapeutic vaccine against a cohort containing only CIN3 patients.",2020,"Compared to the measurements at V1 (baseline), the patients at V8 with HPV clearance showed significantly higher fold-changes in their IFN-γ ELISPOT responses compared to those without HPV clearance.","['72 patients were enrolled and underwent randomization', 'CIN3 patients positive for HPV type 16/18', 'patients with cervical intraepithelial neoplasia 3', '64 patients were included in per-protocol analysis (V7) and 52 in extension analysis (V8']","['HPV DNA vaccine', 'therapeutic DNA vaccine GX-188E', 'GX-188E']","['histopathological regression', 'HPV clearance and histopathological regression', 'HPV clearance', 'IFN-γ ELISPOT responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0201679', 'cui_str': 'Human papillomavirus typing (procedure)'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]","[{'cui': 'C0376613', 'cui_str': 'Vaccines, Recombinant DNA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0920508', 'cui_str': 'ELISPOT'}]",72.0,0.0467475,"Compared to the measurements at V1 (baseline), the patients at V8 with HPV clearance showed significantly higher fold-changes in their IFN-γ ELISPOT responses compared to those without HPV clearance.","[{'ForeName': 'Youn Jin', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': ""Department of Obstetrics and Gynecology, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea (South).""}, {'ForeName': 'Soo Young', 'Initials': 'SY', 'LastName': 'Hur', 'Affiliation': ""Department of Obstetrics and Gynecology, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea (South).""}, {'ForeName': 'Tae-Jin', 'Initials': 'TJ', 'LastName': 'Kim', 'Affiliation': 'Cheil General Hospital, Seoul, Republic of Korea (South).'}, {'ForeName': 'Sung Ran', 'Initials': 'SR', 'LastName': 'Hong', 'Affiliation': 'Cheil General Hospital, Seoul, Republic of Korea (South).'}, {'ForeName': 'Jae Kwan', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Korea University Guro Hospital, Seoul, Republic of Korea (South).'}, {'ForeName': 'Chi-Heum', 'Initials': 'CH', 'LastName': 'Cho', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, Republic of Korea (South).'}, {'ForeName': 'Ki Seok', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Genexine, Inc., Seongnam-si, Republic of Korea (South).'}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Woo', 'Affiliation': 'Genexine, Inc., Seongnam-si, Republic of Korea (South).'}, {'ForeName': 'Young Chul', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Department of Life Sciences, Pohang University of Science and Technology (POSTECH), Gyeonggbuk, Republic of Korea (South).'}, {'ForeName': 'You Suk', 'Initials': 'YS', 'LastName': 'Suh', 'Affiliation': 'Genexine, Inc., Seongnam-si, Republic of Korea (South). jspark@catholic.ac.kr yousuh@gmail.com.'}, {'ForeName': 'Jong Sup', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': ""Department of Obstetrics and Gynecology, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea (South). jspark@catholic.ac.kr yousuh@gmail.com.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1513']
312,31732522,A Th1/IFNγ Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer.,"PURPOSE
Immune components of the tumor microenvironment (TME) have been associated with disease outcome. We prospectively evaluated the association of an immune-related gene signature (GS) with clinical outcome in melanoma and non-small cell lung cancer (NSCLC) tumor samples from two phase III studies.
EXPERIMENTAL DESIGN
The GS was prospectively validated using an adaptive signature design to optimize it for the sample type and technology used in phase III studies. One-third of the samples were used as ""training set""; the remaining two thirds, constituting the ""test set,"" were used for the prospective validation of the GS.
RESULTS
In the melanoma training set, the expression level of eight Th1/IFNγ-related genes in tumor-positive lymph node tissue predicted the duration of disease-free survival (DFS) and overall survival (OS) in the placebo arm. This GS was prospectively and independently validated as prognostic in the test set. Building a multivariate Cox model in the test set placebo patients from clinical covariates and the GS score, an increased number of melanoma-involved lymph nodes and the GS were associated with DFS and OS. This GS was not associated with DFS in NSCLC, although expression of the Th1/IFNγ-related genes was associated with the presence of lymphocytes in tumor samples in both indications.
CONCLUSIONS
These findings provide evidence that expression of Th1/IFNγ genes in the TME, as measured by this GS, is associated with clinical outcome in melanoma. This suggests that, using this GS, patients with stage IIIB/C melanoma can be classified into different risk groups.",2020,"This GS was not associated with DFS in NSCLC, although expression of the Th1/IFN-γ-related genes was associated with the presence of lymphocytes in tumor samples in both indications.
",['melanoma and non-small cell lung cancer (NSCLC) tumor samples from two Phase III studies'],[],"['number of melanoma-involved LNs and the GS', 'expression level of eight T-helper (Th1)/interferon (IFN)-γ-related genes in tumor-positive lymph node (LN) tissue predicted the duration of disease-free survival (DFS) and overall survival (OS']","[{'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0440747', 'cui_str': 'Lymph node tissue (substance)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0974445,"This GS was not associated with DFS in NSCLC, although expression of the Th1/IFN-γ-related genes was associated with the presence of lymphocytes in tumor samples in both indications.
","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Dizier', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Callegaro', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Debois', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dreno', 'Affiliation': 'Department of Dermato-oncology, Hotel Dieu Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hersey', 'Affiliation': 'Melanoma Immunology and Oncology Group, Centenary Institute, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Gogas', 'Affiliation': 'Department of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'Department of Medicine and UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Johan F', 'Initials': 'JF', 'LastName': 'Vansteenkiste', 'Affiliation': 'Department of Respiratory Diseases, University Hospitals KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lecia V', 'Initials': 'LV', 'LastName': 'Sequist', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Djordje', 'Initials': 'D', 'LastName': 'Atanackovic', 'Affiliation': 'Oncology/Hematology/Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Goeman', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van Houwelingen', 'Affiliation': 'Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Salceda', 'Affiliation': 'Thermo Fisher Scientific, Pleasanton, California.'}, {'ForeName': 'Fawn', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Thermo Fisher Scientific, Pleasanton, California.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Therasse', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Channa', 'Initials': 'C', 'LastName': 'Debruyne', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Spiessens', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Vincent G', 'Initials': 'VG', 'LastName': 'Brichard', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Jamila', 'Initials': 'J', 'LastName': 'Louahed', 'Affiliation': 'GSK, Rixensart, Belgium.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ulloa-Montoya', 'Affiliation': 'GSK, Rixensart, Belgium. fernando.x.ulloa-montoya@gsk.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-3717']
313,32236818,The effects of nigella sativa on anthropometric and biochemical indices in postmenopausal women with metabolic syndrome.,"PURPOSE
This study aimed to compare the nigella sativa vs. placebo effect on anthropometric and biochemical indices in postmenopausal women with metabolic syndrome.
METHODS
This randomized, double-blinded, placebo-controlled trial was conducted as a third-phase trial among 140 menopausal women within the age of 45-60 years old, who were suffering from metabolic syndrome and were assigned to receive 500 mg nigella sativa or placebo pill once daily. Anthropometric and biochemical parameters including body weight, waist circumference, serum lipid profile, fasting blood sugar, and HbA1C were measured at baseline and 8 weeks after administration the ingredient or placebo.
RESULTS
In nigella sativa group, the serum markers such as low-density lipoprotein (115.1 ± 17.6 vs. 127.7 ± 12.6), triglyceride (158.3 ± 14.0 vs. 166.7 ± 16.0), total cholesterol (115.1 ± 17.6 vs. 127.7 ± 12.6), and fasting blood sugar (90.8 ± 16.9 vs. 113.7 ± 12.1) decreased significantly compared with the placebo (p < 0.001).
CONCLUSION
Administration of nigella sativa might be recommended for improving lipid profile and blood sugar in postmenopausal women with the metabolic syndrome.",2020,"In nigella sativa group, the serum markers such as low-density lipoprotein (115.1 ± 17.6 vs. 127.7 ± 12.6), triglyceride (158.3 ± 14.0 vs. 166.7 ± 16.0), total cholesterol (115.1 ± 17.6 vs. 127.7 ± 12.6), and fasting blood sugar (90.8 ± 16.9 vs. 113.7 ± 12.1) decreased significantly compared with the placebo (p < 0.001).
","['140 menopausal women within the age of 45-60 years old, who were suffering from metabolic syndrome', 'postmenopausal women with the metabolic syndrome', 'postmenopausal women with metabolic syndrome']","['500\u2009mg nigella sativa or placebo pill once daily', 'nigella sativa', 'placebo']","['fasting blood sugar', 'triglyceride', 'total cholesterol', 'lipid profile and blood sugar', 'serum markers such as low-density lipoprotein', 'body weight, waist circumference, serum lipid profile, fasting blood sugar, and HbA1C']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",140.0,0.54455,"In nigella sativa group, the serum markers such as low-density lipoprotein (115.1 ± 17.6 vs. 127.7 ± 12.6), triglyceride (158.3 ± 14.0 vs. 166.7 ± 16.0), total cholesterol (115.1 ± 17.6 vs. 127.7 ± 12.6), and fasting blood sugar (90.8 ± 16.9 vs. 113.7 ± 12.1) decreased significantly compared with the placebo (p < 0.001).
","[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Shirazi', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Khodakarami', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Feizabad', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Ghaemi', 'Affiliation': 'Maternal, Fetal & Neonatal Research Centre, Tehran University of Medical Sciences, Tehran, Iran. marjan_ghaemi@yahoo.com.'}]",Endocrine,['10.1007/s12020-020-02265-w']
314,32236923,[Biliary tract cancer: on the way to a personalized therapy].,"Biliary tract cancer (BTC) is a rare disease with a heterogeneous nomenclature. Carcinomas of the intra- and extrahepatic biliary tract as well as gallbladder cancer are oftentimes combined in clinical research and treatment algorithms. However, these different cancer types vary not only in their anatomical features, but also in the underlying molecular alterations.Surgery remains the only chance of cure. Adjuvant chemotherapy with capecitabine for 6 months should be recommended after curative intended surgery. In the palliative first-line treatment of advanced BTC, the combination chemotherapy gemcitabine and cisplatin remains the only evidence-based standard. For second-line treatment, the combination of 5-FU, folinic acid and oxaliplatin (FOLFOX) is a treatment option based on preliminary data from a randomized phase 3 study. Potential targeted therapies showing efficacy in prospective clinical studies are, for example, IDH-, BRAF-/MEK- and FGFR-inhibitors as well as immunotherapy. Therefore, in the era of personalized medicine, molecular testing should be offered to all patients with advanced disease and indication for systemic treatment.",2020,"Therefore, in the era of personalized medicine, molecular testing should be offered to all patients with advanced disease and indication for systemic treatment.","['Biliary tract cancer (BTC', 'patients with advanced disease and indication for systemic treatment', 'Biliary tract cancer']","['5-FU, folinic acid and oxaliplatin (FOLFOX', 'Adjuvant chemotherapy with capecitabine', 'chemotherapy gemcitabine and cisplatin']",[],"[{'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0053251', 'cui_str': 'Benzotrichloride'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]",[],,0.0279217,"Therefore, in the era of personalized medicine, molecular testing should be offered to all patients with advanced disease and indication for systemic treatment.","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Sinn', 'Affiliation': 'Universitäres Cancer Center Hamburg-Eppendorf.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Wege', 'Affiliation': 'Universitäres Cancer Center Hamburg-Eppendorf.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Universitäres Cancer Center Hamburg-Eppendorf.'}]",Deutsche medizinische Wochenschrift (1946),['10.1055/a-0974-9694']
315,31536118,Optimizing the growth of very-low-birth-weight infants requires targeting both nutritional and nonnutritional modifiable factors specific to stage of hospitalization.,"BACKGROUND
Data on how baseline characteristics, acuity, morbidity, and nutrition work in combination to affect the growth of very-low-birth-weight (VLBW, <1500 g) infants are limited.
OBJECTIVE
We aimed to determine factors associated with in-hospital weight, length, and head circumference (HC) trajectories of VLBW infants.
METHODS
VLBW infants (n = 316) from the GTA-DoMINO trial were included. Linear mixed-effects models assessed relations of baseline characteristics, acuity (at birth, across hospitalization), major morbidities, and nutrition (enteral feeding type, macronutrient/energy intakes) with changes in anthropometrics over hospitalization (days 1-8, 9-29, 30-75).
RESULTS
Specific factors and the strength of their associations with growth depended on in-hospital time interval. Small-for-gestational-age infants experienced weight gain (4.3 g · kg-1 · d-1; 95% CI: 2.0, 6.5 g · kg-1 · d-1) during days 1-8, versus weight loss (-4.6 g · kg-1 · d-1; 95% CI: -5.6, -3.7 g · kg-1 · d-1) among appropriate-for-gestational-age infants (P < 0.001). Positive-pressure ventilation (versus oxygen/room air) was associated with slower weight (-1.8 g · kg-1 · d-1) and HC (-0.25 cm/wk) gain during days 9-29 (P < 0.001). Morbidities were negatively associated with growth after days 1-8, with patent ductus arteriosus (PDA) showing negative associations with weight (-2.7 g · kg-1 · d-1), length (-0.11 cm/wk), and HC (-0.21 cm/wk) gain during days 9-29 (P < 0.001). Macronutrient/energy intakes were associated with weight across hospitalization (P ≤ 0.01), with greater weight gain (1.3-3.0 g · kg-1 · d-1) among infants achieving macronutrient/energy recommendations during days 9-29 and 30-75. Macronutrient/energy intakes were associated with HC during the first month (P = 0.013-0.003), with greater HC gain (0.07-0.12 cm/wk) among infants achieving protein, lipid, and energy recommendations during days 9-29.
CONCLUSIONS
Baseline characteristics, acuity, morbidity, and nutrition factors were independently associated with VLBW infant growth. A focus on achieving macronutrient/energy recommendations and improving nutrient delivery to PDA-diagnosed infants may yield improvements to their growth. This trial was registered at www.isrctn.com as ISRCTN35317141.",2019,"Macronutrient/energy intakes were associated with weight across hospitalization (P ≤ 0.01), with greater weight gain (1.3-3.0 g · kg-1 · d-1) among infants achieving macronutrient/energy recommendations during days 9-29 and 30-75.",['VLBW infants (n = 316) from the GTA-DoMINO trial were included'],['HC'],"['Morbidities', 'hospital weight, length, and head circumference (HC) trajectories', 'baseline characteristics, acuity (at birth, across hospitalization), major morbidities, and nutrition (enteral feeding type, macronutrient/energy intakes) with changes in anthropometrics over hospitalization', 'Positive-pressure ventilation', 'weight gain', 'slower weight', 'Macronutrient/energy intakes', 'weight loss', 'acuity, morbidity, and nutrition factors', 'HC gain']","[{'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.361397,"Macronutrient/energy intakes were associated with weight across hospitalization (P ≤ 0.01), with greater weight gain (1.3-3.0 g · kg-1 · d-1) among infants achieving macronutrient/energy recommendations during days 9-29 and 30-75.","[{'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Asbury', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Unger', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dawn V Y', 'Initials': 'DVY', 'LastName': 'Ng', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yunnie', 'Initials': 'Y', 'LastName': 'Luk', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bando', 'Affiliation': 'Translational Medicine Program, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Bishara', 'Affiliation': 'Women & Babies Program, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz227']
316,31903682,"Efficacy of 10-20-30 training versus moderate-intensity continuous training on HbA1c, body composition and maximum oxygen uptake in male patients with type 2 diabetes: A randomized controlled trial.","AIM
To compare the efficacy of 10-20-30 training versus moderate-intensity continuous training (MICT) on HbA1c, body composition and maximum oxygen uptake (V˙O 2 max) in male patients with type 2 diabetes (T2D).
MATERIALS AND METHODS
Fifty-one male participants with T2D were randomly assigned (1:1) to a 10-20-30 (N = 26) and a MICT (N = 25) training group. Interventions consisted of supervised cycling three times weekly for 10 weeks, lasting 29 minutes (10-20-30) and 50 minutes (MICT) in a local non-clinical setting. The primary outcome was change in HbA1c from baseline to 10-week follow-up.
RESULTS
Of 51 participants enrolled, 44 (mean age 61.0 ± 6.8 [mean ± SD] years, diagnosed 7.5 ± 5.8 years, baseline HbA1c 7.4% ± 1.3%) were included in the analysis. Training compliance was 84% and 86% in 10-20-30 and MICT, respectively. No adverse events occurred during the intervention. HbA1c decreased (P <0.001) by 0.5 (95% CI -0.72 to -0.21) percentage points with training in 10-20-30, with no change in MICT. The change in 10-20-30 was greater (P <0.05) than in MICT. Visceral fat mass decreased (P <0.05) only with 10-20-30 training, whereas total fat mass decreased (P <0.01) and V˙O 2 max increased (P <0.01) with training in both groups.
CONCLUSIONS
Ten weeks of 10-20-30 training was superior to MICT in lowering HbA1c, and only 10-20-30 training decreased visceral fat mass in patients with T2D. Furthermore, 10-20-30 training was as effective as MICT in reducing total fat mass and increasing V˙O 2 max, despite a 42% lower training time commitment.",2020,"Visceral fat mass decreased (P<0.05) only with 10-20-30 training, whereas total fat mass decreased (P<0.01) and V&c.dotab;O 2 max increased (P<0.01) with training in both groups.
","['male patients with type 2 diabetes (T2D', 'Department of Nutrition, Exercise and Sports, University of Copenhagen (August 2017 - August 2019', 'Of 51 participants enrolled, 44 (mean age, 61.0±6.8 (mean±SD) years, diagnose, 7.5±5.8\u2009years, baseline HbA 1c , 7.4±1.3%) were included in the analysis', 'male patients with type 2 diabetes', 'patients with T2D', 'Fifty-one male participants with T2D']","['MICT (n=25) training group', '10-20-30 training versus moderate-intensity continuous training', '10-20-30 training versus moderate-intensity continuous training (MICT']","['glycosylated hemoglobin', 'visceral fat mass', 'Training compliance', 'total fat mass', 'HbA 1c', 'HbA 1c , body composition and maximum oxygen uptake', 'HbA 1c , body composition, and maximum oxygen uptake (V&c.dotab;O 2 max', 'adverse events', 'total fat mass decreased (P<0.01) and V&c.dotab;O 2 max', 'Visceral fat mass']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",51.0,0.0941995,"Visceral fat mass decreased (P<0.05) only with 10-20-30 training, whereas total fat mass decreased (P<0.01) and V&c.dotab;O 2 max increased (P<0.01) with training in both groups.
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Baasch-Skytte', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte T', 'Initials': 'CT', 'LastName': 'Lemgart', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads H', 'Initials': 'MH', 'LastName': 'Oehlenschläger', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pernille E', 'Initials': 'PE', 'LastName': 'Petersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hostrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Gunnarsson', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13953']
317,31903712,"Exenatide once weekly slows gastric emptying of solids and liquids in healthy, overweight people at steady-state concentrations.","AIMS
To evaluate the effects of 8 weeks' administration of exenatide (EXE) once weekly on gastric emptying of solids and liquids (using the ""gold standard"" technique, scintigraphy), glucose absorption and postprandial glycaemia in healthy people.
MATERIAL AND METHODS
A total of 32 healthy participants were randomized to receive either EXE once weekly (2 mg/wk subcutaneously; six men, 10 women, mean age 59.9 ± 0.9 years, mean body mass index [BMI] 29.6 ± 0.6 kg/m 2 ) or matching placebo (PBO; six men, 10 women, mean age 60.6 ± 1.2 years, mean BMI 29.5 ± 1.0 kg/m 2 ) for 8 weeks. Gastric emptying, nausea (visual analogue scale), and plasma glucose, insulin, C-peptide and glucagon were measured for 120 min after a solid/liquid meal, comprising 100 g ground beef (radiolabelled with 20 MBq 99m Tc-sulphur colloid) and 150 mL 10% glucose (radiolabelled with 7 MBq 67 Ga-EDTA), and containing 5 g 3-O-methyl-glucose (3-OMG) as a marker of glucose absorption, at baseline and after 8 weeks' treatment.
RESULTS
The study treatments were well tolerated. Scores for nausea were consistently low, with no difference between the EXE once weekly and PBO groups. EXE once weekly slowed gastric emptying of solids (area under the curve [AUC] 0-120min : P < 0.05) and liquids (AUC 0-120min : P = 0.01) substantially, and attenuated glucose absorption (3-OMG incremental AUC [iAUC] 0-30min : P = 0.001) and the postprandial rise in plasma glucose (iAUC 0-30min : P = 0.008). Plasma glucagon at 2 h was reduced by EXE once weekly (P = 0.001). The magnitude of the reduction in plasma glucose at t = 30 min from baseline to 8 weeks with EXE once weekly was related inversely to the 50% emptying time of the glucose drink (r = -0.55, P = 0.03).
CONCLUSIONS
In healthy participants, 8 weeks' administration of the ""long-acting"" glucagon-like peptide-1 receptor agonist EXE, slowed gastric emptying of solids and liquids substantially, with consequent reductions in glucose absorption and postprandial glycaemia.",2020,ExQW slowed gastric emptying of solids (e.g. AUC 0-120min: P<0.05) and liquids (e.g. AUC 0-120min: P=0.01) substantially and attenuated glucose absorption (e.g. 3-OMG iAUC 0-30min: P=0.001) and the postprandial rise in plasma glucose (e.g. iAUC 0-30min: P=0.008).,"['Thirty two healthy participants', 'healthy, overweight, subjects under steady-state concentrations', 'healthy subjects']","['Exenatide', '150ml 10% glucose (radiolabelled with 7MBq 67 Ga-EDTA), and containing 5g 3-O-methyl-glucose (3-OMG', 'matching placebo (PLAC', 'ExQW', 'exenatide once-weekly (ExQW']","['ExQW slowed gastric emptying of solids', 'gastric emptying of solids and liquids', 'postprandial rise in plasma glucose', 'Scores for nausea', 'plasma glucose', 'glucose absorption and postprandial glycaemia', 'glucose absorption', 'Gastric emptying, nausea (visual analog scale), and plasma glucose, insulin, C-peptide and glucagon', 'Plasma glucagon', 'tolerated']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0303225', 'cui_str': 'Gallium-67'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048838', 'cui_str': 'PLAC'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}]",32.0,0.108799,ExQW slowed gastric emptying of solids (e.g. AUC 0-120min: P<0.05) and liquids (e.g. AUC 0-120min: P=0.01) substantially and attenuated glucose absorption (e.g. 3-OMG iAUC 0-30min: P=0.001) and the postprandial rise in plasma glucose (e.g. iAUC 0-30min: P=0.008).,"[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Lian Q', 'Initials': 'LQ', 'LastName': 'Huynh', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Seva', 'Initials': 'S', 'LastName': 'Hatzinikolas', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Rachael S', 'Initials': 'RS', 'LastName': 'Rigda', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Liza K', 'Initials': 'LK', 'LastName': 'Phillips', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Hung T', 'Initials': 'HT', 'LastName': 'Pham', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Chinmay S', 'Initials': 'CS', 'LastName': 'Marathe', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Malbert', 'Affiliation': 'Ani-Scan, Institut National de la Rechercher Agronomique, Saint-Gilles, France.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Stevens', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Victoria, Melbourne, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School, University of Adelaide, South Australia, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13956']
318,31903724,"A greater proportion of participants with type 2 diabetes achieve treatment targets with insulin degludec/liraglutide versus insulin glargine 100 units/mL at 26 weeks: DUAL VIII, a randomized trial designed to resemble clinical practice.","This report presents the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as initial injectable therapy at 26 weeks in the 104-week DUAL VIII durability trial (NCT02501161). Participants (N = 1012) with type 2 diabetes (T2D) uncontrolled on oral antidiabetic drugs (OADs) were randomized 1:1 to open-label IDegLira or IGlar U100. Visits were scheduled at weeks 1, 2, 4 and 12, and every 3 months thereafter. After 26 weeks, glycated haemoglobin (HbA1c) reductions were greater with IDegLira versus IGlar U100 (-21.5 vs. -16.4 mmol/mol [-2.0 vs. -1.5%]), as was the percentage of participants achieving HbA1c <53 mmol/mol (78.7% vs. 55.7%) and HbA1c targets without weight gain and/or hypoglycaemia. Estimated treatment differences for insulin dose (-13.01 U) and body weight change (-1.57 kg) significantly favoured IDegLira. The hypoglycaemia rate was 44% lower with IDegLira versus IGlar U100. Safety results were similar. In a trial resembling clinical practice, more participants receiving IDegLira than IGlar U100 met treatment targets, supporting use of IDegLira as an initial injectable therapy for people with T2D uncontrolled on OADs and eligible for insulin initiation.",2020,"Estimated treatment differences for insulin dose (-13.01U), and body weight change (-1.57kg) significantly favored IDegLira.","['participants with type 2 diabetes', 'participants receiving IDegLira than IGlar U100 met treatment targets, supporting use of IDegLira as an initial injectable therapy for people with T2D uncontrolled on OADs and eligible for insulin initiation', 'Participants (N=1012) with type 2 diabetes (T2D) uncontrolled on oral antidiabetic drugs (OADs']","['open-label IDegLira or IGlar U100', 'IDegLira (insulin degludec/liraglutide', 'insulin glargine', 'insulin degludec/liraglutide (IDegLira) versus insulin glargine']","['body weight change', 'hypoglycaemia rate', 'weight gain and/or hypoglycaemia']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C4308663', 'cui_str': 'IDegLira'}, {'cui': 'C4059165', 'cui_str': 'insulin degludec / liraglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",,0.065827,"Estimated treatment differences for insulin dose (-13.01U), and body weight change (-1.57kg) significantly favored IDegLira.","[{'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Sesti', 'Affiliation': 'Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bardtrum', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Selcuk', 'Initials': 'S', 'LastName': 'Dagdelen', 'Affiliation': 'Department of Endocrinology and Metabolism, Hacettepe University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Halladin', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haluzík', 'Affiliation': 'Institute for Clinical and Experimental Medicine and Institute of Endocrinology, Prague, Czech Republic.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Őrsy', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rodríguez', 'Affiliation': 'Area of Endocrinology, Metabolism and Nutrition, Faculty of Medical Sciences, National University of Cuyo, Mendoza, Argentina.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts, United States.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13957']
319,31912603,Prediction and validation of exenatide risk marker effects on progression of renal disease: Insights from EXSCEL.,"AIM
To assess whether the previously developed multivariable risk prediction framework (PRE score) could predict the renal effects observed in the EXSCEL cardiovascular outcomes trial using short-term changes in cardio-renal risk markers.
MATERIALS AND METHODS
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated. The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD). Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
RESULTS
Compared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria. The PRE score predicted a relative risk reduction for the 30% eGFR decline + ESRD endpoint of 11.3% (HR 0.89; 95% CI 0.83-0.94), compared with 12.7% (HR 0.87; 0.77-0.99) observed risk reduction. For the 40% eGFR decline + ESRD endpoint, the predicted and observed risk reductions were 11.0% (HR 0.89; 0.82-0.97) and 13.7% (HR 0.86, 0.72-1.04), respectively.
CONCLUSIONS
Integrating short-term risk marker changes into a multivariable risk score predicted the magnitude of renal risk reduction observed in EXSCEL.",2020,"Compared with placebo, mean HbA 1c , BMI, SBP, and total cholesterol were lower at six months with exenatide, as was the incidence of new microalbuminuria.","['patients with T2D', 'patients with type 2 diabetes (T2D']","['placebo', 'exenatide', 'Glucagon-like peptide-1 receptor agonists (GLP-1 RA']","['estimated glomerular filtration rate (eGFR) or end-stage renal disease', 'renal risk reduction', 'renal outcomes', 'eGFR decline + ESRD endpoint', 'mean HbA 1c , BMI, SBP, and total cholesterol', 'incidence of new microalbuminuria', 'risk reductions', 'glycated hemoglobin (HbA 1c ), systolic blood pressure (SBP), body mass index (BMI), hemoglobin, total cholesterol, and new micro- or macroalbuminuria']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C3811844'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0730345', 'cui_str': 'Microalbuminuria (finding)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}]",,0.0307143,"Compared with placebo, mean HbA 1c , BMI, SBP, and total cholesterol were lower at six months with exenatide, as was the incidence of new microalbuminuria.","[{'ForeName': 'Nienke M A', 'Initials': 'NMA', 'LastName': 'Idzerda', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Clegg', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, United States.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Bakris', 'Affiliation': 'University of Chicago Medicine, Chicago, Illinois, United States.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Penland', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Waltham, Boston, Massachusetts, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13958']
320,31822848,Effectiveness of the Genomics ADvISER decision aid for the selection of secondary findings from genomic sequencing: a randomized clinical trial.,"PURPOSE
To evaluate the effectiveness of the Genomics ADvISER (www.genomicsadviser.com) decision aid (DA) for selection of secondary findings (SF), compared with genetic counseling alone.
METHODS
A randomized controlled trial (RCT) was conducted to evaluate whether the Genomics ADvISER is superior to genetic counseling when hypothetically selecting SF. Participants were randomized to use the DA followed by discussion with a genetic counselor, or to genetic counseling alone. Surveys were administered at baseline and post-intervention. Primary outcome was decisional conflict. Secondary outcomes were knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session.
RESULTS
Participants (n = 133) were predominantly White/European (74%), female (90%), and ≥50 years old (60%). Decisional conflict (mean difference 0.05; P = 0.60), preparation for decision-making (0.17; P = 0.95), satisfaction with decision (-2.18; P = 0.06), anxiety (0.72; P = 0.56), and knowledge of sequencing limitations (0.14; P = 0.70) did not significantly differ between groups. However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001) CONCLUSIONS: The Genomics ADvISER did not decrease decisional conflict but reduced counseling time and improved knowledge. This decision aid could serve as an educational tool, reducing in-clinic time and potentially health care costs.",2020,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","['Participants (n\u2009=\u2009133) were predominantly White/European (74%), female (90%), and ≥50 years old (60']","['Genomics ADvISER (www.genomicsadviser.com) decision aid (DA', 'DA followed by discussion with a genetic counselor, or to genetic counseling alone', 'genetic counseling alone']","['knowledge, preparation for, and satisfaction with decision-making, anxiety, and length of counseling session', 'counseling time and improved knowledge', 'knowledge of sequencing limitations', 'knowledge of SF', 'shorter counseling time', 'anxiety', 'Decisional conflict', 'decisional conflict']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0017382', 'cui_str': 'Genetic counseling'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}]",133.0,0.134204,"However, intervention participants had significantly higher knowledge of SF (0.39; P < 0.001) and sequencing benefits (0.97; P = 0.01), and significantly shorter counseling time (24.40 minutes less; P < 0.001)","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada. yvonne.bombard@utoronto.ca.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Casalino', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Theresa H M', 'Initials': 'THM', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Muir', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Baxter', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Adena', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Piccinin', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Mancuso', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Semotiuk', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Offit', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jada G', 'Initials': 'JG', 'LastName': 'Hamilton', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Gaithersburg, MD, USA.'}, {'ForeName': 'Kasmintan', 'Initials': 'K', 'LastName': 'Schrader', 'Affiliation': 'Department of Molecular Oncology and Hereditary Cancer Program, BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Laupacis', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0702-z']
321,31836609,Proliferation and AKT Activity Biomarker Analyses after Capivasertib (AZD5363) Treatment of Patients with ER + Invasive Breast Cancer (STAKT).,"PURPOSE
The STAKT study examined short-term exposure (4.5 days) to the oral selective pan-AKT inhibitor capivasertib (AZD5363) to determine if this drug can reach its therapeutic target in sufficient concentration to significantly modulate key biomarkers of the AKT pathway and tumor proliferation.
PATIENTS AND METHODS
STAKT was a two-stage, double-blind, randomized, placebo-controlled, ""window-of-opportunity"" study in patients with newly diagnosed ER + invasive breast cancer. Stage 1 assessed capivasertib 480 mg b.i.d. (recommended monotherapy dose) and placebo, and stage 2 assessed capivasertib 360 and 240 mg b.i.d. Primary endpoints were changes from baseline in AKT pathway markers pPRAS40, pGSK3β, and proliferation protein Ki67. Pharmacologic and pharmacodynamic properties were analyzed from blood sampling, and tolerability by adverse-event monitoring.
RESULTS
After 4.5 days' exposure, capivasertib 480 mg b.i.d. ( n = 17) produced significant decreases from baseline versus placebo ( n = 11) in pGSK3β (H-score absolute change: -55.3, P = 0.006) and pPRAS40 (-83.8, P < 0.0001), and a decrease in Ki67 (absolute change in percentage positive nuclei: -9.6%, P = 0.031). Significant changes also occurred in secondary signaling biomarker pS6 (-42.3, P = 0.004), while pAKT (and nuclear FOXO3a) also increased in accordance with capivasertib's mechanism (pAKT: 81.3, P = 0.005). At doses of 360 mg b.i.d. ( n = 5) and 240 mg b.i.d. ( n = 6), changes in primary and secondary biomarkers were also observed, albeit of smaller magnitude. Biomarker modulation was dose and concentration dependent, and no new safety signals were evident.
CONCLUSIONS
Capivasertib 480 mg b.i.d. rapidly modulates key biomarkers of the AKT pathway and decreases proliferation marker Ki67, suggesting future potential as an effective therapy in AKT-dependent breast cancers.",2020,"Significant changes also occurred in secondary signaling biomarker pS6 (-42.3, P = 0.004), while pAKT (and nuclear FOXO3a) also increased in accordance with capivasertib's mechanism (pAKT: 81.3, P = 0.005).","['patients with newly diagnosed ER + invasive breast cancer', 'Patients with ER + Invasive Breast Cancer (STAKT']","['oral selective pan-AKT inhibitor capivasertib (AZD5363', 'placebo']","['changes from baseline in AKT pathway markers pPRAS40, pGSK3β, and proliferation protein Ki67', 'secondary signaling biomarker pS6']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3502775', 'cui_str': 'AZD5363'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.083844,"Significant changes also occurred in secondary signaling biomarker pS6 (-42.3, P = 0.004), while pAKT (and nuclear FOXO3a) also increased in accordance with capivasertib's mechanism (pAKT: 81.3, P = 0.005).","[{'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, UK. john.robertson@nottingham.ac.uk.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Coleman', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Kwok-Leung', 'Initials': 'KL', 'LastName': 'Cheung', 'Affiliation': 'University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Holcombe', 'Affiliation': 'Royal Liverpool University Hospital, Liverpool, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Skene', 'Affiliation': 'Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Bournemouth, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samreen', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jahan', 'Affiliation': ""King's Mill Hospital, Nottingham, UK.""}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Horgan', 'Affiliation': 'Leeds General Infirmary, Leeds, UK.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rauchhaus', 'Affiliation': 'University of Dundee, Dundee, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Littleford', 'Affiliation': 'University of Dundee, Dundee, UK.'}, {'ForeName': 'S Y Amy', 'Initials': 'SYA', 'LastName': 'Cheung', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Cullberg', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Elza C', 'Initials': 'EC', 'LastName': 'de Bruin', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Loumpiana', 'Initials': 'L', 'LastName': 'Koulai', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Justin P O', 'Initials': 'JPO', 'LastName': 'Lindemann', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pass', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rugman', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Deb', 'Affiliation': 'Department of Histopathology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Finlay', 'Affiliation': 'Cardiff University, Cardiff, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'IMED Biotech Unit, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Julia M W', 'Initials': 'JMW', 'LastName': 'Gee', 'Affiliation': 'Cardiff University, Cardiff, UK.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3053']
322,32242480,High-Frequency External Muscle Stimulation Reduces Depressive Symptoms in Older Male Veterans: A Pilot Study.,"OBJECTIVE
Late-life depression (LLD) is a severe public health problem. Given that pharmacological treatments for LLD are limited by their side effects, development of efficient and tolerable nonpharmacological treatment for LLD is urgently required. This study investigated whether high-frequency external muscle stimulation could reduce depressive symptoms in LLD.
METHODS
Twenty-two older male veterans with major depression were recruited and randomized into a treatment (n = 9) or sham control group (n = 13). The groups received high-frequency external muscle stimulation or sham intervention 3 times per week for 12 weeks. Clinical symptoms and muscle strength were evaluated at baseline and every 2 weeks.
RESULTS
The 2 groups were homogeneous in age, baseline clinical symptoms, and muscle strength. The treatment group showed significant improvement in depression and anxiety scores and muscle strength (all P < .01), whereas the control group showed no significant change after the 12-week follow-up. Compared to the control group, the treatment group showed significant improvements in depression (Geriatric Depression Scale, P = .009; Hamilton Depression Rating Scale, P = .007) and anxiety scores (HAMA, P = .008) and muscle strength (all P < .001). Changes in depression and anxiety levels were significantly correlated with changes in muscle strength after the study. In the treatment group, we observed a trend of correlation between the reduction in depression and muscle strength gains.
CONCLUSION
High-frequency external muscle stimulation appears to be an effective treatment for older patients with LLD. Large studies with more tests and/or conducted in different populations are warranted to validate these preliminary findings.",2021,"Compared to the control group, the treatment group showed significant improvements in depression (Geriatric Depression Scale, P = .009; Hamilton Depression Rating Scale, P = .007) and anxiety scores (HAMA, P = .008) and muscle strength (all P < .001).","['Twenty-two older male veterans with major depression', 'older patients with LLD', 'Older Male Veterans']","['High-Frequency External Muscle Stimulation', 'high-frequency external muscle stimulation or sham intervention', 'High-frequency external muscle stimulation', 'high-frequency external muscle stimulation']","['Depressive Symptoms', 'depressive symptoms', 'anxiety scores (HAMA, P = .008) and muscle strength', 'depression and anxiety scores and muscle strength', 'depression (Geriatric Depression Scale, P = .009; Hamilton Depression Rating Scale', 'depression and muscle strength gains', 'depression and anxiety levels', 'muscle strength', 'Clinical symptoms and muscle strength']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1291910', 'cui_str': 'Human anti-mouse antibody'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",22.0,0.0185276,"Compared to the control group, the treatment group showed significant improvements in depression (Geriatric Depression Scale, P = .009; Hamilton Depression Rating Scale, P = .007) and anxiety scores (HAMA, P = .008) and muscle strength (all P < .001).","[{'ForeName': 'Mu-N', 'Initials': 'MN', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, 46615Taipei Veterans General Hospital, Taipei.'}, {'ForeName': 'Heng-Liang', 'Initials': 'HL', 'LastName': 'Yeh', 'Affiliation': 'Health Care Group, Taipei Veterans Home, New-Taipei City.'}, {'ForeName': 'Ai Seon', 'Initials': 'AS', 'LastName': 'Kuan', 'Affiliation': 'Institute of Public Health, National Yang-Ming University, Taipei.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, 46615Taipei Veterans General Hospital, Taipei.'}, {'ForeName': 'Ying-Jay', 'Initials': 'YJ', 'LastName': 'Liou', 'Affiliation': 'Department of Psychiatry, 46615Taipei Veterans General Hospital, Taipei.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Walsh', 'Affiliation': 'Applied Cognitive Neuroscience Group, Institute of Cognitive Neuroscience, 4919University College London, London, United Kingdom.'}, {'ForeName': 'Chi-Ieong', 'Initials': 'CI', 'LastName': 'Lau', 'Affiliation': 'Applied Cognitive Neuroscience Group, Institute of Cognitive Neuroscience, 4919University College London, London, United Kingdom.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988720915524']
323,31557344,Concordance of Self- and Partner-Reported Alcohol Consumption Among Couples Experiencing Intimate Partner Violence in Zambia.,"BACKGROUND
Hazardous alcohol use is a predictor of intimate partner violence (IPV), and both are increasingly prevalent in sub-Saharan Africa. The accurate measurement of alcohol consumption is therefore critical in IPV intervention studies that target hazardous drinking. Collecting a collateral report in addition to self-report is one convergent validity approach to improve alcohol measurement. We investigated concordance between self- and partner-reported alcohol use among women who reported recent IPV and their male partners in Zambia.
METHODS
Data were from the baseline of a randomized IPV intervention trial of 247 heterosexual couples in which a woman has reported recent IPV and her male partner has recent hazardous alcohol use. Both partners completed the Alcohol Use Disorders Identification Test (AUDIT) in reference to their own drinking and in reference to their partner's drinking. We calculated percent agreement across a range of outcomes: any use, quantity, frequency, and hazardous use. We also compared self- and partner-reported AUDIT scores using t-tests.
RESULTS
Concordance was poor across most outcomes. Percent agreement with respect to the women's drinking ranged from 60% to 65% across outcomes and with respect to the men's drinking from 51% to 89%. Women's average partner-reported AUDIT score (20.7) was statistically significantly (p < 0.0001) higher than men's average self-reported score (15.8).
CONCLUSIONS
In contrast to collateral report studies conducted in the United States, concordance between self- and partner-reported alcohol consumption was poor among families experiencing IPV in Zambia. Given the possible biases associated with self-reported alcohol use, findings suggest that a convergent validity approach is useful in this research context.",2019,Percent agreement with respect to the women's drinking ranged from 60% to 65% across outcomes and with respect to the men's drinking from 51% to 89%.,"['women who reported recent IPV and their male partners in Zambia', 'couples experiencing intimate partner violence in Zambia', '247 heterosexual couples in which a woman has reported recent IPV and her male partner has recent hazardous alcohol use']",[],"['quantity, frequency, and hazardous use']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",[],"[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0138763,Percent agreement with respect to the women's drinking ranged from 60% to 65% across outcomes and with respect to the men's drinking from 51% to 89%.,"[{'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, (JCK, SMM, MCG, SLF, LKM), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, (JCK, SMM, MCG, SLF, LKM), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Vinikoor', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, (MJV), Birmingham, Alabama.'}, {'ForeName': 'M Claire', 'Initials': 'MC', 'LastName': 'Greene', 'Affiliation': 'Department of Mental Health, (JCK, SMM, MCG, SLF, LKM), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Shoshanna L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Mental Health, (JCK, SMM, MCG, SLF, LKM), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Paul', 'Affiliation': 'Department of Psychiatry, (RP), University Teaching Hospital, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, (JCK, SMM, MCG, SLF, LKM), Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14205']
324,31984648,Gluten-free diet in children with recent-onset type 1 diabetes: A 12-month intervention trial.,"AIM
To test whether a gluten-free diet (GFD) is associated with the deceleration of the decline in beta-cell capacity in non-coeliac children with recently diagnosed type 1 diabetes.
METHODS
Forty-five children (aged 10.2 ± 3.3 years) were recruited into a self-selected intervention trial: 26 started with a GFD within a median of 38 days postonset, whereas 19 remained on a standard diet. The main outcomes were the decline in C-peptide area under the curve (AUC) in mixed-meal tolerance tests (MMTTs) at 6 and 12 months relative to 1 month after diabetes onset and the difference in insulin dose, insulin dose-adjusted A1c (IDAA1c) and HbA1c assessed every 3 months. The adherence to the GFD was verified by immunoreactive gluten in the stool and by food questionnaires at every visit. Quality of life (QoL) questionnaires were administered to the participants at the end of the intervention at 12 months. The data were analysed as per protocol (in 39 subjects who duly completed the whole follow-up: 20 in the GFD group, 19 in the control group) by linear and longitudinal regression models adjusted for sex, age and baseline variables.
RESULTS
At 12 months, the difference in C-peptide AUC between subjects in the GFD group and controls was 205 pmol/L (95% CI -223 to 633; P = 0.34) in a model adjusted for age, sex and body weight, and for baseline insulin dose, MMTT C-peptide AUC and HbA1c assessed at 1 month after diagnosis. In a longitudinal analysis of all three time points adjusted for age, sex and body weight, C-peptide declined more slowly in the GFD group than in controls, with the difference in trends being 409 pmol/L/year (P = 0.04). The GFD group had a marginally lower insulin dose (by 0.15 U/kg/day; P = 0.07), a lower IDAA1c (by 1.37; P = 0.01) and a lower mean HbA1c (by 0.7% [7.8 mmol/mol]; P = 0.02) than those of the controls at 12 months. There was no appreciable difference between the groups in daily carbohydrate intake (P = 0.49) or in the QoL reported by the patients (P = 0.70) and their parents/caregivers (P = 0.59).
CONCLUSIONS
A GFD maintained over the first year after type 1 diabetes diagnosis was associated with better HbA1c and a prolonged partial remission period. There was a hint of slower C-peptide decline but the association was not strong enough to make definite conclusions.",2020,"There was no appreciable difference between the groups in daily carbohydrate intake (P = 0.49) or in the QoL reported by the patients (P = 0.70) and their parents (P= 0.59).
","['nonceliac children with recently diagnosed T1D.\nMETHODS\n\n\nForty-five children (aged 10.2±3.3\u2009years', 'children with recent-onset type 1 diabetes']","['Gluten-free diet', 'gluten-free diet (GFD', 'GFD']","['lower IDAA1c', 'quality of life (QoL) questionnaires', 'C-peptide AUC', 'decline in C-peptide area under the curve (AUC) in mixed-meal tolerance tests (MMTT', 'daily carbohydrate intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201777', 'cui_str': 'Tolerance test (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}]",45.0,0.0515302,"There was no appreciable difference between the groups in daily carbohydrate intake (P = 0.49) or in the QoL reported by the patients (P = 0.70) and their parents (P= 0.59).
","[{'ForeName': 'Vit', 'Initials': 'V', 'LastName': 'Neuman', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Stepanka', 'Initials': 'S', 'LastName': 'Pruhova', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kulich', 'Affiliation': 'Department of Probability and Mathematical Statistics, Faculty of Mathematics and Physics, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Stanislava', 'Initials': 'S', 'LastName': 'Kolouskova', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vosahlo', 'Affiliation': 'Department of Pediatrics, 3rd Faculty of Medicine, Charles University and Kralovske Vinohrady University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Romanova', 'Affiliation': 'Department of Pediatrics, 3rd Faculty of Medicine, Charles University and Kralovske Vinohrady University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Petruzelkova', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Obermannova', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Funda', 'Affiliation': 'Institute of Microbiology of the Czech Academy of Sciences, Prague, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Cinek', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Zdenek', 'Initials': 'Z', 'LastName': 'Sumnik', 'Affiliation': 'Department of Pediatrics, 2nd Faculty of Medicine, Charles University and Motol University Hospital, Prague, Czech Republic.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13974']
325,32242808,Musculoskeletal ultrasound to complement clinical evaluation and drive treatment of rheumatoid arthritis patients in remission does not prevent worsening of patient-reported outcomes: the ULTRAPRO randomised controlled study.,"OBJECTIVES
The primary objective was to determine the impact of sharing musculoskeletal ultrasound (MUS) results with rheumatologists on worsening patient-reported outcomes (PROs) at 6 months of follow-up in rheumatoid arthritis (RA) patients with clinical remission. Secondary objectives were to describe MUS findings and to compare the proportion of patients with flares, according to the DAS28-ESR, following the intervention.
METHODS
Ninety-four consecutive outpatients with clinical remission had PROs and a treatment proposal recorded at study entry. MUS was then performed by trained specialists who were blinded to clinical assessments. Forty-seven patients were randomised (1:1) to either the intervention group (MUS data shared with the primary rheumatologist) or the control group (data not shared); changes in the treatment proposal were recorded. PROs worsening and the proportion of patients with ares were compared between both groups at 6±2 months of follow-up. The study received IRB approval. Appropriate statistics were used.
RESULTS
At baseline, patients from the intervention and control groups had similar characteristics; 43 and 41 patients, respectively, completed the 6-month follow-up period. PROs worsening at 6 months of follow-up were similar between groups, as were the DAS28-ESR and the proportion of patients who flared. In general, MUS findings were in accordance with the clinical remission status, although power Doppler synovitis was detected in up to 37% of the patients. RA-related treatment was increased in all the patients from the intervention group with discordant findings between clinical and MUS assessments.
CONCLUSIONS
The addition of MUS to clinical evaluation of RA outpatients in remission did not prevent worsening PROs at 6 months.",2020,"RA-related treatment was increased in all the patients from the intervention group with discordant findings between clinical and MUS assessments.
","['rheumatoid arthritis (RA) patients with clinical remission', 'Ninety-four consecutive outpatients with clinical remission had PROs and a treatment proposal recorded at study entry', 'rheumatoid arthritis patients', 'Forty-seven patients']","['MUS', 'intervention group (MUS data shared with the primary rheumatologist', 'sharing musculoskeletal ultrasound (MUS', 'Musculoskeletal ultrasound']","['PROs worsening and the proportion of patients with ares', 'RA-related treatment', 'power Doppler synovitis', 'proportion of patients with flares', 'PROs worsening']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}]",47.0,0.0499742,"RA-related treatment was increased in all the patients from the intervention group with discordant findings between clinical and MUS assessments.
","[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Sifuentes-Cantú', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Subirán, Mexico City, Mexico.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Butrón-Hernández', 'Affiliation': 'Department of Radiology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Subirán, Mexico City, Mexico.'}, {'ForeName': 'Irazú', 'Initials': 'I', 'LastName': 'Contreras-Yáñez', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Subirán, Mexico City, Mexico.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Pascual-Ramos', 'Affiliation': 'Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Subirán, Mexico City, Mexico. virtichu@gmail.com.'}]",Clinical and experimental rheumatology,[]
326,31515553,"Associations of plasma, RBCs, and hair carbon and nitrogen isotope ratios with fish, meat, and sugar-sweetened beverage intake in a 12-wk inpatient feeding study.","BACKGROUND
Naturally occurring carbon and nitrogen stable isotope ratios [13C/12C (CIR) and 15N/14N (NIR)] are promising dietary biomarkers. As these candidate biomarkers have long tissue residence times, long-term feeding studies are needed for their evaluation.
OBJECTIVE
Our aim was to evaluate plasma, RBCs, and hair CIR and NIR as biomarkers of fish, meat, and sugar-sweetened beverage (SSB) intake in a 12-wk dietary intervention.
METHODS
Thirty-two men (aged 46.2 ± 10.5 y; BMI: 27.2 ± 4.0 kg/m2) underwent a 12-wk inpatient dietary intervention at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in Phoenix, Arizona. The effects of fish, meat, and SSB intake on CIR and NIR were evaluated using a balanced factorial design, with each intake factor at 2 levels (present/absent) in a common, background diet (50% carbohydrate, 30% fat, 20% protein). Fasting blood samples were taken biweekly from baseline, and hair samples were collected at baseline and postintervention. Data were analyzed using multivariable regression.
RESULTS
The postintervention CIR of plasma was elevated when diets included meat (β = 0.89, 95% CI: 0.73,1.05) and SSBs (β = 0.48, 95% CI: 0.32, 0.64). The postintervention NIR of plasma was elevated when diets included fish (β = 0.85, 95% CI: 0.64, 1.05) and meat (β = 0.61, 95% CI: 0.42, 0.8). Results were similar for RBCs and hair. Postintervention RBC CIR and NIR had strong associations with baseline, suggesting that turnover to the intervention diets was incomplete after 12 wk. Estimates of isotopic turnover rate further confirmed incomplete turnover of RBCs.
CONCLUSIONS
CIR was associated with meat and SSBs, and more strongly with meat. NIR was associated with fish and meat, and more strongly with fish. Overall, CIR and NIR discriminated between dietary fish and meat, and to a lesser extent SSBs, indicating their potential utility as biomarkers of intake in US diets. Approaches to make these biomarkers more specific are needed. This trial was registered at clinicaltrials.gov as NCT01237093.",2019,"The postintervention CIR of plasma was elevated when diets included meat (β = 0.89, 95% CI: 0.73,1.05) and SSBs (β = 0.48, 95% CI: 0.32, 0.64).",['Thirty-two men (aged 46.2\xa0±\xa010.5 y'],"['fish, meat, and SSB intake', '12-wk inpatient dietary intervention', 'Naturally occurring carbon and nitrogen stable isotope ratios [13C/12C (CIR) and 15N/14N (NIR']","['postintervention NIR of plasma', 'postintervention CIR of plasma', 'Fasting blood samples', 'plasma, RBCs, and hair carbon and nitrogen isotope ratios with fish, meat, and sugar-sweetened beverage intake', 'plasma, RBCs, and hair CIR and NIR as biomarkers of fish, meat, and sugar-sweetened beverage (SSB) intake']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0028162', 'cui_str': 'Nitrogen isotope'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0472025,"The postintervention CIR of plasma was elevated when diets included meat (β = 0.89, 95% CI: 0.73,1.05) and SSBs (β = 0.48, 95% CI: 0.32, 0.64).","[{'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Votruba', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Shaw', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Venti', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bonfiglio', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases/NIH, Phoenix, AZ, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': ""O'Brien"", 'Affiliation': 'Center for Alaska Native Health Research, Institute of Arctic Biology, Department of Biology and Wildlife, University of Alaska Fairbanks, Fairbanks, AK, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz208']
327,32058845,Hippocampal Avoidance During Whole-Brain Radiotherapy Plus Memantine for Patients With Brain Metastases: Phase III Trial NRG Oncology CC001.,"PURPOSE
Radiation dose to the neuroregenerative zone of the hippocampus has been found to be associated with cognitive toxicity. Hippocampal avoidance (HA) using intensity-modulated radiotherapy during whole-brain radiotherapy (WBRT) is hypothesized to preserve cognition.
METHODS
This phase III trial enrolled adult patients with brain metastases to HA-WBRT plus memantine or WBRT plus memantine. The primary end point was time to cognitive function failure, defined as decline using the reliable change index on at least one of the cognitive tests. Secondary end points included overall survival (OS), intracranial progression-free survival (PFS), toxicity, and patient-reported symptom burden.
RESULTS
Between July 2015 and March 2018, 518 patients were randomly assigned. Median follow-up for alive patients was 7.9 months. Risk of cognitive failure was significantly lower after HA-WBRT plus memantine versus WBRT plus memantine (adjusted hazard ratio, 0.74; 95% CI, 0.58 to 0.95; P = .02). This difference was attributable to less deterioration in executive function at 4 months (23.3% v 40.4%; P = .01) and learning and memory at 6 months (11.5% v 24.7% [ P = .049] and 16.4% v 33.3% [ P = .02], respectively). Treatment arms did not differ significantly in OS, intracranial PFS, or toxicity. At 6 months, using all data, patients who received HA-WBRT plus memantine reported less fatigue ( P = .04), less difficulty with remembering things ( P = .01), and less difficulty with speaking ( P = .049) and using imputed data, less interference of neurologic symptoms in daily activities ( P = .008) and fewer cognitive symptoms ( P = .01).
CONCLUSION
HA-WBRT plus memantine better preserves cognitive function and patient-reported symptoms, with no difference in intracranial PFS and OS, and should be considered a standard of care for patients with good performance status who plan to receive WBRT for brain metastases with no metastases in the HA region.",2020,"Risk of cognitive failure was significantly lower after HA-WBRT plus memantine versus WBRT plus memantine (adjusted hazard ratio, 0.74; 95% CI, 0.58 to 0.95; P = .02).","['Patients With Brain Metastases', 'Between July 2015 and March 2018, 518 patients were randomly assigned', 'adult patients with brain metastases to HA-WBRT plus']","['WBRT', 'HA-WBRT plus memantine', 'Whole-Brain Radiotherapy Plus Memantine', 'WBRT plus memantine', 'Hippocampal avoidance (HA) using intensity-modulated radiotherapy during whole-brain radiotherapy (WBRT', 'memantine or WBRT plus memantine']","['overall survival (OS), intracranial progression-free survival (PFS), toxicity, and patient-reported symptom burden', 'interference of neurologic symptoms in daily activities', 'Risk of cognitive failure', 'cognitive symptoms', 'Hippocampal Avoidance', 'fatigue', 'OS, intracranial PFS, or toxicity', 'time to cognitive function failure, defined as decline using the reliable change index on at least one of the cognitive tests', 'learning and memory', 'difficulty with remembering things', 'deterioration in executive function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0525041', 'cui_str': 'Cognitive Symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",518.0,0.148098,"Risk of cognitive failure was significantly lower after HA-WBRT plus memantine versus WBRT plus memantine (adjusted hazard ratio, 0.74; 95% CI, 0.58 to 0.95; P = .02).","[{'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Brown', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Vinai', 'Initials': 'V', 'LastName': 'Gondi', 'Affiliation': 'Northwestern Medicine Cancer Center Warrenville and Northwestern Medicine Proton Center, Warrenville, IL.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Wolfgang A', 'Initials': 'WA', 'LastName': 'Tome', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Wefel', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'National Cancer Institute Center for Cancer Research, Bethesda, MD.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Bovi', 'Affiliation': 'Froedtert & the Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Robinson', 'Affiliation': 'Washington University in St Louis, St Louis, MO.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Konski', 'Affiliation': 'Chester County Hospital, West Chester, PA.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Khuntia', 'Affiliation': 'East Bay Radiation Oncology Center, Eden Medical Center, Castro Valley, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grosshans', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Tammie L S', 'Initials': 'TLS', 'LastName': 'Benzinger', 'Affiliation': 'Washington University in St Louis, St Louis, MO.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bruner', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gilbert', 'Affiliation': 'National Cancer Institute Center for Cancer Research, Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roberge', 'Affiliation': 'CHUM-Hôtel-Dieu de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Vijayananda', 'Initials': 'V', 'LastName': 'Kundapur', 'Affiliation': 'Saskatoon Cancer Center, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Devisetty', 'Affiliation': 'Wayne State University, Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Sunjay', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'ChristianaCare National Cancer Institute Community Oncology Research Program, Newark, DE.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Usuki', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Bethany Marie', 'Initials': 'BM', 'LastName': 'Anderson', 'Affiliation': 'University of Wisconsin Hospitals and Clinics, Madison, WI.'}, {'ForeName': 'Baldassarre', 'Initials': 'B', 'LastName': 'Stea', 'Affiliation': 'University of Arizona Medical Center-University Campus, Tucson, AZ.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Heartland Cancer Research National Cancer Institute Community Oncology Research Program, Decatur, IL.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Nadia N', 'Initials': 'NN', 'LastName': 'Laack', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Kruser', 'Affiliation': 'Northwestern Memorial Hospital, Chicago, IL.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Chmura', 'Affiliation': 'The University of Chicago Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Wenyin', 'Initials': 'W', 'LastName': 'Shi', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, PA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, PA.'}, {'ForeName': 'Minesh P', 'Initials': 'MP', 'LastName': 'Mehta', 'Affiliation': 'Miami Cancer Institute, Miami, FL.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kachnic', 'Affiliation': 'Vanderbilt University Medical Center, Ingram Cancer Center, Nashville, TN.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02767']
328,31647125,Attention control group activities and perceived benefit in a trial of a behavioral intervention for older adults.,"Researchers trialing behavioral interventions often use attention control groups, but few publish details on attention control activities or perceived benefit. Attention control groups receive the same dose of interpersonal interaction as intervention participants but no other elements of the intervention, to control for the benefits of attention that may come from behavioral interventions. Because intervention success is analyzed compared to control conditions, it is useful to examine attention control content and outcomes. The purpose of this study is to report on attention control visit activities and their perceived benefit in a randomized control trial. The trial tested an aging-in-place intervention comprised of a series of participant goal-directed visits facilitated by an occupational therapist, nurse, and handyman. The attention control group participants received visits from a lay person. We report on the number and length of visits received, types of visit activities that participants chose, and how much visit time was spent on each activity, based on the attention visitor's records. We report on participant perceptions of benefit based on a 10-item Likert-scale survey. The attention control group participants (n = 148) were cognitively intact, at least 65 years old, with at least one Instrumental Activities of Daily Living. Attention control group participants most often chose conversation (20.1% of visit time), and playing games (18.7%), as visit activities. The majority of attention control group participants (63.4%) reported ""a great deal"" of perceived benefit. Attention control group visits may be an appropriate comparison in studies of behavioral interventions for community-dwelling older adults.",2019,"The majority of attention control group participants (63.4%) reported ""a great deal"" of perceived benefit.","['group participants (n\u2009=\u2009148) were cognitively intact, at least 65 years old, with at least one Instrumental Activities of Daily Living', 'older adults', 'community-dwelling older adults']","['attention control', 'behavioral intervention']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0334081,"The majority of attention control group participants (63.4%) reported ""a great deal"" of perceived benefit.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'LaFave', 'Affiliation': 'Center for Innovative Care in Aging, School of Nursing, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Granbom', 'Affiliation': 'Center for Innovative Care in Aging, School of Nursing, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas K M', 'Initials': 'TKM', 'LastName': 'Cudjoe', 'Affiliation': 'Center on Aging and Health, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gottsch', 'Affiliation': 'Duke University Hospital, Durham, North Carolina.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Shorb', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Center for Innovative Care in Aging, School of Nursing, Johns Hopkins University, Baltimore, Maryland.'}]",Research in nursing & health,['10.1002/nur.21992']
329,31599919,A ketone monoester drink reduces the glycemic response to an oral glucose challenge in individuals with obesity: a randomized trial.,"BACKGROUND
Exogenous ketones make it possible to reach a state of ketosis that may improve metabolic control in humans.
OBJECTIVES
The main objective of this study was to determine whether the ingestion of a ketone monoester (KE) drink before a 2-h oral-glucose-tolerance test (OGTT) would lower blood glucose concentrations. Secondary objectives were to determine the impact of KE on nonesterified fatty acid (NEFA) concentration and glucoregulatory hormones.
METHODS
We conducted a randomized controlled crossover experiment in 15 individuals with obesity (mean ± SD age: 47 ± 10 y; BMI: 34 ± 5 kg/m2). After an overnight fast, participants consumed a KE drink [(R)-3-hydroxybutyl (R)-3-hydroxybutyrate; 0.45 mL/kg body weight] or taste-matched control drink 30 min before completing a 75-g OGTT. Participants and study personnel performing laboratory analyses were blinded to each condition.
RESULTS
The KE increased d-β-hydroxybutyrate to a maximum of ∼3.4 mM (P < 0.001) during the OGTT. Compared with the control drink, KE reduced glucose (-11%, P = 0.002), NEFA (-21%, P = 0.009), and glucagon-like peptide 1 (-31%, P = 0.001) areas under the curve (AUCs), whereas glucagon AUC increased (+11%, P = 0.030). No differences in triglyceride, C-peptide, and insulin AUCs were observed after the KE drink. Mean arterial blood pressure decreased and heart rate increased after the KE drink (both P < 0.01).
CONCLUSIONS
A KE drink consumed before an OGTT lowered glucose and NEFA AUCs with no increase in circulating insulin. Our results suggest that a single drink of KE may acutely improve metabolic control in individuals with obesity. Future research is warranted to examine whether KE could be used safely to have longer-term effects on metabolic control. This trial was registered at clinicaltrials.gov as NCT03461068.",2019,"Compared with the control drink, KE reduced glucose (-11%, P = 0.002), NEFA (-21%, P = 0.009), and glucagon-like peptide 1 (-31%, P = 0.001) areas under the curve (AUCs), whereas glucagon AUC increased (+11%, P = 0.030).","['10', '15 individuals with obesity (mean\xa0±', 'individuals with obesity']","['ketone monoester (KE) drink before a 2-h oral-glucose-tolerance test (OGTT', 'ketone monoester drink', 'KE drink [(R)-3-hydroxybutyl (R)-3-hydroxybutyrate; 0.45 mL/kg body weight] or taste-matched control drink 30 min before completing a 75-g OGTT', 'KE']","['nonesterified fatty acid (NEFA) concentration and glucoregulatory hormones', 'glycemic response', 'Mean arterial blood pressure decreased and heart rate', 'blood glucose concentrations', 'NEFA', 'metabolic control', 'glucagon AUC', 'KE reduced glucose', 'circulating insulin', 'triglyceride, C-peptide, and insulin AUCs', 'KE increased d-β-hydroxybutyrate']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C3529323', 'cui_str': '(R)-3-hydroxybutyl (R)-3-hydroxybutyrate'}, {'cui': 'C4068884', 'cui_str': '0.45'}, {'cui': 'C0560714', 'cui_str': 'milliliter/kilogram body weight'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",30.0,0.346903,"Compared with the control drink, KE reduced glucose (-11%, P = 0.002), NEFA (-21%, P = 0.009), and glucagon-like peptide 1 (-31%, P = 0.001) areas under the curve (AUCs), whereas glucagon AUC increased (+11%, P = 0.030).","[{'ForeName': 'Étienne', 'Initials': 'É', 'LastName': 'Myette-Côté', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Hannah G', 'Initials': 'HG', 'LastName': 'Caldwell', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Ainslie', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiology, Anatomy, and Genetics, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia Okanagan, Kelowna, British Columbia, Canada.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz232']
330,32229139,The short-term effect of dark chocolate flavanols on cognition in older adults: A randomized controlled trial (FlaSeCo).,"BACKGROUND
Cocoa flavanols in the diet have had positive effects on cognition, blood lipid levels, and glucose metabolism.
METHODS
Cognitively healthy older adults aged 65-75 years were recruited for an eight-week randomized, double-blind controlled trial to investigate the effectiveness of cocoa flavanols on cognitive functions. At baseline, nutrient and polyphenol intakes from diet were assessed with three-day food diaries. The intervention group received 50 g dark chocolate containing 410 mg of flavanols per day, and the control group 50 g dark chocolate containing 86 mg of flavanols per day, for eight weeks. Cognition was assessed with Verbal Fluency (VF) and the Trail Making Test (TMT) A and B as the main outcome measures. Changes in blood lipids and glucose were also measured.
RESULTS
The older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74). They were highly educated with a mean 14.9 years of education (SD 3.6). No differences in changes in cognition were seen between groups. The mean change (± SEs) in the time to complete the TMT A and B in the intervention group was -4.6 s (-7.1 to -2.1) and -16.1 s (-29.1 to -3.1), and in the controls -4.4 s (-7.0 to -1.9) and -12.5 s (-22.8 to -2.1)(TMT A p = 0.93; TMT B p = 0.66). No difference was apparent in the changes in blood lipids, glucose levels, or body weight between the groups.
CONCLUSIONS
The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.",2020,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"['older adults', 'healthy older adults', 'older adults participating numbered 100 (63% women), mean 69 y (range 65 to 74', 'Cognitively healthy older adults aged 65-75\u202fyears', 'They were highly educated with a mean 14.9\u202fyears of education (SD 3.6']","['cocoa flavanols', '50\u202fg dark chocolate containing 410\u202fmg of flavanols per day, and the control group 50\u202fg dark chocolate containing 86\u202fmg of flavanols', 'dark chocolate flavanols', '2.1)(TMT']","['mean change (± SEs', 'blood lipids and glucose', 'Verbal Fluency (VF) and the Trail Making Test (TMT', 'cognitive functions', 'changes in cognition', 'cognition, blood lipid levels, and glucose metabolism', 'blood lipids, glucose levels, or body weight']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0857756', 'cui_str': 'Highly educated'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C4521844', 'cui_str': 'Cocoa'}, {'cui': 'C3853217', 'cui_str': 'Dark chocolate (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0700198,The healthy older adults showed no effect from the eight-week intake of dark chocolate flavanols on cognition.,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland. Electronic address: merja.suominen@gery.fi.'}, {'ForeName': 'M M L', 'Initials': 'MML', 'LastName': 'Laaksonen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Salmenius-Suominen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland; Society for Gerontological Nutrition, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'S-M', 'Initials': 'SM', 'LastName': 'Hongisto', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Tuukkanen', 'Affiliation': 'Fazer Group, Finland.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Jyväkorpi', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Pitkälä', 'Affiliation': 'Department of General Practice and Primary Health Care, University of Helsinki, Finland.'}]",Experimental gerontology,['10.1016/j.exger.2020.110933']
331,31012225,Automatic EPAP intelligent volume-assured pressure support is effective in patients with chronic respiratory failure: A randomized trial.,"BACKGROUND AND OBJECTIVE
Patients with chronic respiratory failure are increasingly managed with domiciliary non-invasive ventilation (NIV). There may be limited ability to provide NIV titration for these complex patients, and ventilatory requirements and upper airway support needs may change over time. Therefore, an automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm may offer advantages over manually adjusted EPAP for treating these patients. This study compared 4% oxygen desaturation index (ODI4%) values during the use of an AutoEPAP algorithm versus manual EPAP titration with the intelligent volume-assured pressure support (iVAPS) algorithm.
METHODS
This prospective, single-blind, randomized, crossover study was conducted at six US sites. Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea-hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the iVAPS manual EPAP and iVAPS AutoEPAP in the sleep laboratory in random order.
RESULTS
A total of 38 patients constituted the study population. Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001). There was no difference in the effect on ODI4% across respiratory failure subgroups. Ventilation parameters and gas exchange were similar with either NIV mode, indicating equally effective treatment of respiratory failure. Sleep parameters were improved during AutoEPAP versus manual EPAP.
CONCLUSION
A single night of NIV using the iVAPS with AutoEPAP algorithm was non-inferior to a single night of iVAPS with manual EPAP titration in patients with respiratory failure.
CLINICAL TRIAL REGISTRATION
NCT02683772 at clinicaltrials.gov.",2019,Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001).,"['Patients with chronic respiratory failure (neuromuscular disease, chronic obstructive pulmonary disease, obesity hypoventilation and other aetiologies) and an apnoea-hypopnoea index of >5/h who were already established NIV users underwent a single night of NIV with the', 'patients with chronic respiratory failure', '38 patients constituted the study population', 'patients with respiratory failure', 'Patients with chronic respiratory failure']","['Automatic EPAP intelligent volume-assured pressure support', 'AutoEPAP', 'AutoEPAP algorithm versus manual EPAP titration', 'automatically adjusting expiratory positive airway pressure (AutoEPAP) algorithm', 'iVAPS manual EPAP and iVAPS AutoEPAP', 'iVAPS with manual EPAP titration']","['Mean ODI4', 'oxygen desaturation index (ODI4%) values', 'Sleep parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264492', 'cui_str': 'Chronic respiratory failure (disorder)'}, {'cui': 'C0027868', 'cui_str': 'Neuromuscular Diseases'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3203358', 'cui_str': 'Hypoventilation'}, {'cui': 'C1314792', 'cui_str': 'Causality'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0002045'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C3697361', 'cui_str': 'Expiratory positive airway pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",38.0,0.0800875,Mean ODI4% was statistically non-inferior with AutoEPAP versus manual EPAP (P < 0.0001).,"[{'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Department of Medicine and Neurology, Northwestern Medical Hospital, Chicago, IL, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Department of Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Krishna M', 'Initials': 'KM', 'LastName': 'Sundar', 'Affiliation': 'Department of Medicine, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Sheila C', 'Initials': 'SC', 'LastName': 'Tsai', 'Affiliation': 'National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Adam V', 'Initials': 'AV', 'LastName': 'Benjafield', 'Affiliation': 'ResMed Science Center, San Diego, CA, USA.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Crocker', 'Affiliation': 'ResMed Science Center, San Diego, CA, USA.'}, {'ForeName': 'Leslee', 'Initials': 'L', 'LastName': 'Willes', 'Affiliation': 'Willes Consulting Group, San Diego, CA, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Department of Medicine, University of California, San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Lisa F', 'Initials': 'LF', 'LastName': 'Wolfe', 'Affiliation': 'Department of Medicine and Neurology, Northwestern Medical Hospital, Chicago, IL, USA.'}]","Respirology (Carlton, Vic.)",['10.1111/resp.13546']
332,32227368,Weight suppression and weight maintenance following treatment of anorexia nervosa.,"OBJECTIVE
The value of weight suppression (WS) in predicting the course of anorexia nervosa (AN) is uncertain. The objective of this study was to determine, using data from a previously published study, whether patients who remain weight suppressed following restoration to a minimally normal weight are at greater risk for relapse.
METHOD
Following weight restoration, 93 women with AN were randomly assigned to receive fluoxetine or placebo along with cognitive behavioral therapy for 1 year. WS (highest adult weight minus current weight), body mass index (BMI), and their interaction were assessed as predictors of change in weight over the first 28 days, of successful weight maintenance at 6 and 12 months, and of time to relapse.
RESULTS
Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge.
DISCUSSION
This study found that WS does not substantially impact the likelihood of successful weight maintenance or time to relapse following restoration to a minimally normal weight in AN.",2020,"Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge.
","['93 women with AN', 'anorexia nervosa', 'patients who remain weight suppressed following restoration to a minimally normal weight are at greater risk for relapse']","['fluoxetine or placebo', 'weight suppression (WS', 'cognitive behavioral therapy']","['Weight suppression and weight maintenance', 'successful weight maintenance', 'time to relapse, or weight change', 'WS (highest adult weight minus current weight), body mass index (BMI), and their interaction']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",93.0,0.0544804,"Neither WS nor its interaction with BMI predicted successful weight maintenance at 6 and 12 months, time to relapse, or weight change over the first 28 days following discharge.
","[{'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Uniacke', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Attia', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Kaplan', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23269']
333,31559891,Interactive Effects of Physical Activity and Cognitive Activity on Cognition in Older Adults Without Mild Cognitive Impairment or Dementia.,"Objective: The purpose of this secondary analysis was to test effects of interactions between accelerometer-measured physical activity and self-reported cognitive activity on cognition in older adults without cognitive impairment. Method: Participants were 742 older adults from the Rush Memory and Aging Project who completed annual clinical evaluations. A series of parallel growth models tested effects of interactions between physical activity and cognitive activity on cognition (global index, five domains) at Year 5, controlling for demographics, health factors, and corresponding cognition measures at Year 1. Results: Results were mixed, with significant physical and cognitive activity interactive effects for working and semantic memory. In models without interactions, higher physical and cognitive activities at Year 1 and less decline in cognitive activity over time were independently associated with better cognition at Year 5. Discussion: These findings may inform interventions that enhance physical and cognitive activities to prevent cognitive impairment in older adults.",2020,"In models without interactions, higher physical and cognitive activities at Year 1 and less decline in cognitive activity over time were independently associated with better cognition at Year 5. ","['Older Adults', 'Participants were 742 older adults from the Rush Memory and Aging Project who completed annual clinical evaluations', 'older adults', 'older adults without cognitive impairment']","['Physical Activity and Cognitive Activity', 'accelerometer-measured physical activity and self-reported cognitive activity']","['physical and cognitive activity interactive effects for working and semantic memory', 'cognitive activity', 'physical activity and cognitive activity on cognition (global index, five domains', 'physical and cognitive activities']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443052', 'cui_str': 'Rush (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0542312', 'cui_str': 'Semantic memory (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",742.0,0.0166212,"In models without interactions, higher physical and cognitive activities at Year 1 and less decline in cognitive activity over time were independently associated with better cognition at Year 5. ","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Halloway', 'Affiliation': 'Rush University College of Nursing, Chicago, IL, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Schoeny', 'Affiliation': 'Rush University College of Nursing, Chicago, IL, USA.'}, {'ForeName': 'JoEllen', 'Initials': 'J', 'LastName': 'Wilbur', 'Affiliation': 'Rush University College of Nursing, Chicago, IL, USA.'}, {'ForeName': 'Lisa L', 'Initials': 'LL', 'LastName': 'Barnes', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA.'}]",Journal of aging and health,['10.1177/0898264319875570']
334,29999380,Remembering or knowing how we felt: Depression and anxiety symptoms predict retrieval processes during emotional self-report.,"Researchers and clinicians routinely rely on patients' retrospective emotional self-reports to guide diagnosis and treatment, despite evidence of impaired autobiographical memory and retrieval of emotional information in depression and anxiety. To clarify the nature and specificity of these impairments, we conducted two large online data collections (Study 1, N = 1,983; Study 2, N = 900) examining whether depression and/or anxiety symptoms would uniquely predict the use of self-reported episodic (i.e., remembering) and/or semantic (i.e., knowing) retrieval when rating one's positive and negative emotional experiences over different time frames. Participants were randomly assigned to one of six time frames (ranging from at this moment to last few years ) and were asked to rate how intensely they felt each of four emotions, anxious, sad, calm, and happy, over that period. Following each rating, they were asked several follow-up prompts assessing their perceived reliance on episodic and/or semantic information to rate how they felt, using procedures adapted from the traditional ""remember/know"" paradigm (Tulving, 1985). Across both studies, depression and anxiety symptoms each uniquely predicted increased likelihood of remembering across emotion types, and decreased likelihood of knowing how one felt when rating positive emotion types. Implications for the theory and treatment of emotion-related memory disturbances in depression and anxiety, and for dual-process theories of memory retrieval more generally, are discussed. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Across both studies, depression and anxiety symptoms each uniquely predicted increased likelihood of remembering across emotion types, and decreased likelihood of knowing how one felt when rating positive emotion types.","[""two large online data collections (Study 1, N = 1,983; Study 2, N = 900) examining whether depression and/or anxiety symptoms would uniquely predict the use of self-reported episodic (i.e., remembering) and/or semantic (i.e., knowing) retrieval when rating one's positive and negative emotional experiences over different time frames""]",[],[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}]",[],[],,0.0323354,"Across both studies, depression and anxiety symptoms each uniquely predicted increased likelihood of remembering across emotion types, and decreased likelihood of knowing how one felt when rating positive emotion types.","[{'ForeName': 'Eugenia I', 'Initials': 'EI', 'LastName': 'Gorlin', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Werntz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Karl C', 'Initials': 'KC', 'LastName': 'Fua', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Nauder', 'Initials': 'N', 'LastName': 'Namaky', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Bethany A', 'Initials': 'BA', 'LastName': 'Teachman', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000436']
335,31498264,Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,"BACKGROUND
Tranexamic acid (TXA) is efficacious for reducing blood loss and transfusion use in patients who undergo bilateral TKA, and it is administered intravenously alone, intraarticularly alone, or as a combination of these. However, it is unclear whether combined intravenous (IV) and intraarticular TXA offers any additional benefit over intraarticular use alone in patients undergoing bilateral TKA.
QUESTIONS/PURPOSES
The purposes of our study was to determine (1) whether combined IV and intraarticular TXA reduces blood loss and blood transfusion use compared with intraarticular use alone and (2) whether the frequency of adverse events is different between these routes of administration in patients who undergo simultaneous or staged bilateral TKA.
METHODS
Between April 2015 and May 2017, one surgeon performed 316 same-day bilateral TKAs and 314 staged bilateral TKAs. Of those, 98% of patients in each same-day TKA (310) and staged bilateral TKA (309) groups were eligible for this randomized trial and all of those patients agreed to participate and were randomized. The study included four groups: simultaneous TKA with intraarticular TXA only (n = 157), simultaneous TKA with IV and intraarticular TXA (n = 153), staged TKA with intraarticular TXA only (n = 156), and staged TKA with IV and intraarticular TXA (n = 155). There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values. The primary outcome variables were total blood loss calculated based on patient blood volume and a drop in the hemoglobin level and administration of blood transfusion. The secondary outcomes of this study were a decrease in the postoperative hemoglobin level; the proportion of patients with a hemoglobin level lower than 7.0, 8.0, or 9.0 g/dL; and the frequencies of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, wound complications, and periprosthetic joint infection.
RESULTS
Total blood loss with intraarticular TXA alone in patients undergoing simultaneous bilateral TKA and those undergoing staged procedures was not different from the total blood loss with the combined IV plus intraarticular TXA regimen (1063 mL ± 303 mL versus 1004 mL ± 287 mL, mean difference 59 mL [95% CI -7 to 125]; p = 0.08 and 909 ml ± 283 ml versus 845 ml ± 278 ml; mean difference 64 mL [95% CI 1 to 127]; p = 0.046, respectively). The use of blood transfusions between intraarticular alone and combined IV and intraarticular TXA was also not different among patients undergoing simultaneous (0% [0 of 152] versus 1%; p = 0.149) and staged TKA (1% [1 of 155] versus 0% [0 of 153]; p = 0.98). Furthermore, the frequency of symptomatic thromboembolic events, wound complications, and periprosthetic joint infections was low, without any differences among the groups with the numbers available.
CONCLUSION
Because there was no difference between intraarticular alone and combined intraarticular plus IV regimen of TXA administration, we recommend that IV and intraarticular TXA should not be used in combination. Moreover, other studies have found no differences between intraarticular and IV TXA used alone, and hence to avoid potential complications associated with systemic administration, we recommend that intraarticular alone is sufficient for routine TKA.
LEVEL OF EVIDENCE
Level I, therapeutic study.",2020,"There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values.","['Bilateral TKA', 'patients who undergo simultaneous or staged bilateral TKA', 'patients who undergo bilateral TKA', 'patients undergoing bilateral TKA', 'Between April 2015 and May 2017']","['intraarticular TXA', 'combined intravenous (IV) and intraarticular TXA', 'combined IV and intraarticular TXA', 'staged TKA with intraarticular TXA', 'TKA with intraarticular TXA', 'Intraarticular Tranexamic Acid', 'Tranexamic acid (TXA', 'staged TKA with IV and intraarticular TXA', 'TXA administration', 'IV and intraarticular TXA', 'intraarticular alone and combined IV and intraarticular TXA', 'simultaneous TKA with IV and intraarticular TXA', 'TXA']","['demographic data', 'blood loss and blood transfusion', 'total blood loss', 'blood transfusions', 'Total blood loss', 'frequency of symptomatic thromboembolic events, wound complications, and periprosthetic joint infections', 'postoperative hemoglobin level; the proportion of patients with a hemoglobin level', 'total blood loss calculated based on patient blood volume and a drop in the hemoglobin level and administration of blood transfusion', 'frequencies of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, wound complications, and periprosthetic joint infection']","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1096106'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0005850', 'cui_str': 'Blood Volume'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",316.0,0.107007,"There were no differences in demographic data among the intraarticular alone and IV plus intraarticular TXA groups of patients who underwent simultaneous or staged bilateral TKA in terms of age, proportion of female patients, BMI, or preoperative hematologic values.","[{'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Meshram', 'Affiliation': 'P. Meshram, J. V. Palanisamy, J. Y. Seo, J. G. Lee, Joint Reconstruction Center, Seoul National University Bundang Hospital, Seoul, Republic of Korea T. K. Kim, Department of Orthopaedic Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jeya Venkatesh', 'Initials': 'JV', 'LastName': 'Palanisamy', 'Affiliation': ''}, {'ForeName': 'Jong Yeon', 'Initials': 'JY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Jong Geun', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae Kyun', 'Initials': 'TK', 'LastName': 'Kim', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000942']
336,31800488,Muscarinic and Nicotinic Modulation of Memory but not Verbal Problem-solving.,"Aspects of cognitive flexibility are modulated by the noradrenergic system, which is important in arousal and attention. Acetylcholine also modulates arousal and attention, as well as working memory. Effects of muscarinic and nicotinic antagonism on memory are well established. Our purpose was to test whether muscarinic and nicotinic antagonism affect aspects of cognitive flexibility, specifically verbal problem-solving, as well as memory, given acetylcholine's role in attention and arousal. Eighteen participants attended three testing sessions. Two hours before testing, participants received either 0.6 mg scopolamine, 10 mg mecamylamine, or placebo. Then, participants were tested on three memory tasks (Buschke Selective Reminding Test [BSRT], California Verbal Learning Test [CVLT], Rey Complex Figure Test), two verbal problem-solving/cognitive flexibility tasks (Compound Remote Associates Test, a timed anagram test), and a spatial inductive reasoning task (Raven's Progressive Matrices). Task order and drug order were counterbalanced. Memory impairment was seen on one BSRT measure and multiple CVLT measures with scopolamine, and with one BSRT measure with mecamylamine. There were no effects of either drug on any of the tasks involving cognitive flexibility, including verbal problem-solving. Specific memory impairments were detected using muscarinic, and to a marginal extent, nicotinic antagonists, as expected, but no effect was seen on cognitive flexibility. Therefore, although both the noradrenergic and cholinergic systems play important roles in arousal and cortical signal-to-noise processing, the cholinergic system does not appear to have the same effect as the noradrenergic system on cognitive flexibility, including verbal problem-solving.",2019,"There were no effects of either drug on any of the tasks involving cognitive flexibility, including verbal problem-solving.",['Eighteen participants attended three testing sessions'],"['scopolamine', 'muscarinic and nicotinic antagonism', 'mecamylamine, or placebo', 'mecamylamine', 'Acetylcholine']","[""memory tasks (Buschke Selective Reminding Test [BSRT], California Verbal Learning Test [CVLT], Rey Complex Figure Test), two verbal problem-solving/cognitive flexibility tasks (Compound Remote Associates Test, a timed anagram test), and a spatial inductive reasoning task (Raven's Progressive Matrices"", 'cognitive flexibility, including verbal problem-solving', 'Specific memory impairments', 'cognitive flexibility']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C0026815', 'cui_str': 'Muscarinic Agents'}, {'cui': 'C0025029', 'cui_str': 'Mecamylamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0557033', 'cui_str': 'Reminding (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C0589103', 'cui_str': 'Rey complex figure test'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1449597', 'cui_str': 'Ravens'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}]",18.0,0.0193381,"There were no effects of either drug on any of the tasks involving cognitive flexibility, including verbal problem-solving.","[{'ForeName': 'Shawn F', 'Initials': 'SF', 'LastName': 'Smyth', 'Affiliation': 'Department of Neurology, Johns Hopkins University.'}, {'ForeName': 'David Q', 'Initials': 'DQ', 'LastName': 'Beversdorf', 'Affiliation': 'Departments of Radiology, Neurology, and Psychological Sciences, and the Thompson Center, William and Nancy Thompson Endowed Chair in Radiology, University of Missouri, Columbia, Missouri.'}]",Cognitive and behavioral neurology : official journal of the Society for Behavioral and Cognitive Neurology,['10.1097/WNN.0000000000000208']
337,32223444,Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention: Insights From AUGUSTUS.,"BACKGROUND
In AUGUSTUS (Open-Label, 2×2 Factorial, Randomized, Controlled Clinical Trial to Evaluate the Safety of Apixaban vs Vitamin K Antagonist and Aspirin vs Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome and/or Percutaneous Coronary Intervention), patients with atrial fibrillation and a recent acute coronary syndrome and those undergoing percutaneous coronary intervention had less bleeding with apixaban than vitamin K antagonist (VKA) and with placebo than aspirin. However, the number of ischemic events was numerically higher with placebo. The aim of this analysis is to assess the tradeoff of risk (bleeding) and benefit (ischemic events) over time with apixaban versus VKA and aspirin versus placebo.
METHODS
In AUGUSTUS, 4614 patients with atrial fibrillation and recent acute coronary syndrome or percutaneous coronary intervention on a P2Y 12 inhibitor were randomized to blinded aspirin or placebo and to open-label apixaban or VKA for 6 months. In a post hoc analysis, we compared the risk of 3 composite bleeding outcomes and 3 composite ischemic outcomes from randomization through 30 days and from 30 days to 6 months with apixaban and VKA and with aspirin and placebo.
RESULTS
Compared with VKA, apixaban had either a lower or a similar risk of bleeding and ischemic outcomes from randomization to 30 days and from 30 days to 6 months. From randomization to 30 days, aspirin caused more severe bleeding (absolute risk difference, 0.97% [95% CI, 0.23-1.70]) and fewer severe ischemic events (absolute risk difference, -0.91% [95% CI, -1.74 to -0.08]) than placebo. From 30 days to 6 months, the risk of severe bleeding was higher with aspirin than placebo (absolute risk difference, 1.25% [95% CI, 0.23-2.27]), whereas the risk of severe ischemic events was similar (absolute risk difference, -0.17% [95% CI, -1.33 to 0.98]).
CONCLUSIONS
In patients with atrial fibrillation and recent acute coronary syndrome or percutaneous coronary intervention receiving a P2Y 12 inhibitor, apixaban is preferred over VKA. Use of aspirin immediately and for up to 30 days results in an equal tradeoff between an increase in severe bleeding and a reduction in severe ischemic events. After 30 days, aspirin continues to increase bleeding without significantly reducing ischemic events. These results inform shared, patient-centric decision making on the ideal duration of the use of aspirin after an acute coronary syndrome or percutaneous coronary intervention in patients with atrial fibrillation receiving oral anticoagulation. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02415400.",2020,"From randomization to 30 days, aspirin caused more severe bleeding (absolute risk difference 0.97%, 95% CI 0.23 to 1.70) and fewer severe ischemic events (absolute risk difference -0.91%, 95% CI -1.74 to -0.08) than placebo.","['patients with atrial fibrillation (AF) and a recent acute coronary syndrome (ACS) and/or those undergoing', 'Patients with Atrial Fibrillation', 'patients with AF receiving oral anticoagulation', '4614 patients with AF and recent ACS and/or PCI on a P2Y 12 inhibitor']","['vitamin K antagonist (VKA', 'aspirin', 'placebo', 'Antithrombotic Therapy', 'VKA, apixaban', 'aspirin and placebo', 'aspirin or placebo and to open-label apixaban or VKA', 'percutaneous coronary intervention (PCI', 'apixaban versus VKA and aspirin versus placebo', 'Percutaneous Coronary Intervention']","['severe bleeding', 'risk of severe ischemic events', 'risk of severe bleeding', 'severe ischemic events', 'tradeoff of risk (bleeding) and benefit (ischemic events', 'ischemic events', 'risk of bleeding and ischemic outcomes', 'severe bleeding and reduction in severe ischemic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",4614.0,0.142368,"From randomization to 30 days, aspirin caused more severe bleeding (absolute risk difference 0.97%, 95% CI 0.23 to 1.70) and fewer severe ischemic events (absolute risk difference -0.91%, 95% CI -1.74 to -0.08) than placebo.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Amit N', 'Initials': 'AN', 'LastName': 'Vora', 'Affiliation': 'UPMC Pinnacle, Harrisburg, PA (A.N.V.).'}, {'ForeName': 'Laine', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ (R.A.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.).'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (J.H.A., D.W., L.T., C.B.G., R.D.L.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046534']
338,31988481,Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.,"BACKGROUND
The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness.
METHODS
Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained.
RESULTS
Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY.
CONCLUSIONS
Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.",2020,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","['pupils eligible for free school meals, 20 schools', 'Forty schools']","['Daily Mile', 'Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented']","['Effectiveness and cost-effectiveness', 'physical activity levels', 'childhood weight outcomes and wellbeing', 'BMI z-score (BMIz', 'BMIz', 'incremental cost per Quality-Adjusted-Life-Year (QALY) gained']","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",40.0,0.246083,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Breheny', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Passmore', 'Affiliation': 'Services for Education, Birmingham, B7 4AX, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. p.adab@bham.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Lancashire', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. e.frew@bham.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-019-0511-0']
339,32224306,"Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial.","BACKGROUND
Few options exist for treatment of patients with small-cell lung cancer (SCLC) after failure of first-line therapy. Lurbinectedin is a selective inhibitor of oncogenic transcription. In this phase 2 study, we evaluated the acti and safety of lurbinectedin in patients with SCLC after failure of platinum-based chemotherapy.
METHODS
In this single-arm, open-label, phase 2 basket trial, we recruited patients from 26 hospitals in six European countries and the USA. Adults (aged ≥18 years) with a pathologically proven diagnosis of SCLC, Eastern Cooperative Oncology Group performance status of 2 or lower, measurable disease as per Response Criteria in Solid Tumors (RECIST) version 1.1, absence of brain metastasis, adequate organ function, and pre-treated with only one previous chemotherapy-containing line of treatment (minimum 3 weeks before study initiation) were eligible. Treatment consisted of 3·2 mg/m 2 lurbinectedin administered as a 1-h intravenous infusion every 3 weeks until disease progression or unacceptable toxicity. The primary outcome was the proportion of patients with an overall response (complete or partial response) as assessed by the investigators according to RECIST 1.1. All treated patients were analysed for activity and safety. This study is ongoing and is registered with ClinicalTrials.gov, NCT02454972.
FINDINGS
Between Oct 16, 2015, and Jan 15, 2019, 105 patients were enrolled and treated with lurbinectedin. Median follow-up was 17·1 months (IQR 6·5-25·3). Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2). The most common grade 3-4 adverse events (irrespective of causality) were haematological abnormalities-namely, anaemia (in nine [9%] patients), leucopenia (30 [29%]), neutropenia (48 [46%]), and thrombocytopenia (seven [7%]). Serious treatment-related adverse events occurred in 11 (10%) patients, of which neutropenia and febrile neutropenia were the most common (five [5%] patients for each). No treatment-related deaths were reported.
INTERPRETATION
Lurbinectedin was active as second-line therapy for SCLC in terms of overall response and had an acceptable and manageable safety profile. Lurbinectedin could represent a potential new treatment for patients with SCLC, who have few options especially in the event of a relapse, and is being investigated in combination with doxorubicin as second-line therapy in a randomised phase 3 trial.
FUNDING
Pharma Mar.",2020,Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2).,"['Between Oct 16, 2015, and Jan 15, 2019, 105 patients were enrolled and treated with', 'recruited patients from 26 hospitals in six European countries and the USA', 'patients with SCLC', 'Adults (aged ≥18 years) with a pathologically proven diagnosis of SCLC, Eastern Cooperative Oncology Group performance status of 2 or lower, measurable disease as per Response Criteria in Solid Tumors', 'patients with SCLC after failure of platinum-based chemotherapy', 'patients with small-cell lung cancer (SCLC) after failure of first-line therapy', 'patients with small-cell lung cancer']","['doxorubicin', 'Lurbinectedin', '3·2 mg/m 2 lurbinectedin', 'lurbinectedin']","['leucopenia', 'Overall response', 'proportion of patients with an overall response (complete or partial response', 'activity and safety', 'adverse events', 'neutropenia', 'haematological abnormalities-namely, anaemia', 'neutropenia and febrile neutropenia', 'thrombocytopenia']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C3898565'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}]",105.0,0.123332,Overall response by investigator assessment was seen in 37 patients (35·2%; 95% CI 26·2-45·2).,"[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Trigo', 'Affiliation': 'Hospital Universitario Virgen de la Victoria, Instituto de Investigación Biomédica de Málaga, Málaga, Spain. Electronic address: jmtrigo@seom.org.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Subbiah', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Gustave Roussy Cancer Campus, Villejuif, France; Paris Sud University, Orsay, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'START Madrid-Fundación Jiménez Díaz, Hospital Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'López', 'Affiliation': 'Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'María Angeles', 'Initials': 'MA', 'LastName': 'Sala', 'Affiliation': 'Organización Sanitaria Integrada Bilbao Basurto, Bilbao, Spain.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'University Hospital Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Madrid, Spain.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Fernández', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gómez', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Kahatt', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zeaiter', 'Affiliation': 'Pharma Mar, Clinical Research and Development, Colmenar Viejo, Madrid, Spain.'}, {'ForeName': 'Khalil', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'University Hospital Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Boni', 'Affiliation': 'START Madrid-Centro Integral Oncológico Clara Campal, Hospital Universitario Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Arrondeau', 'Affiliation': 'Hôpital Cochin, Paris, France.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Martínez', 'Affiliation': 'Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kristeleit', 'Affiliation': 'University College London Cancer Institute, London, UK.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Olmedo', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Wannesson', 'Affiliation': 'Ospedale San Giovanni, Bellinzona, Switzerland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Valdivia', 'Affiliation': 'Hospital Universitario Virgen de las Nieves, Granada, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'Rubio', 'Affiliation': 'Hospital Universitario Reina Sofía, Cordoba, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anton', 'Affiliation': 'Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sarantopoulos', 'Affiliation': 'Institute for Drug Development, Mays Cancer Center at University of Texas Health San Antonio, MD Anderson Cancer Center, San Antonio, TX, USA.'}, {'ForeName': 'Sant P', 'Initials': 'SP', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Center, Santa Monica, CA, USA.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Mosquera-Martinez', 'Affiliation': 'Complexo Hospitalario Universitario A Coruña, A Coruña, Spain.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': ""D'Arcangelo"", 'Affiliation': 'Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Humanitas Clinical and Research Center - IRCCS, Humanitas Cancer Center, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Villalobos', 'Affiliation': 'University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Sands', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H120-CNIO Lung Cancer Unit, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Cáncer (CIBERONC), Madrid, Spain.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30068-1']
340,32113878,Benefits of Self-administered Vaginal Dinoprostone 12 Hours before Levonorgestrel-releasing Intrauterine Device Insertion in Nulliparous Adolescents and Young Women: A Randomized Controlled Trial.,"STUDY OBJECTIVE
To assess safety and efficacy of self-administered vaginal dinoprostone 12 hours before a 52-mg levonorgestrel intrauterine device (LNG-IUD) insertion in adolescents and young nulliparous women.
DESIGN
Randomized controlled trial.
SETTING
Tertiary referral hospital.
PARTICIPANTS
Nulliparous adolescents and young women aged 18-22 years.
INTERVENTIONS
Participants were randomly assigned into 2 groups; the dinoprostone group (n = 65) received dinoprostone 3 mg vaginally, and the placebo group (n = 65) received placebo tablets vaginally.
MAIN OUTCOME MEASURES
Primary outcome was pain scores during LNG-IUD insertion measured using a visual analogue scale. Secondary outcomes were pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, Women's satisfaction score, need for additional analgesics, and side effects.
RESULTS
The dinoprostone group had significantly lower pain scores during LNG-IUD insertion (2.83 ± 1.08 vs 3.95 ± 1.63), tenaculum placement (2.97 ± 1.41 vs 4.55 ± 1.53) and sounding of uterus (3.55 ± 1.71 vs 5.12 ± 1.37) compared with the placebo group (P < .001). No significant differences were found between both groups regarding anticipated pain scores (P = .85), pain during speculum insertion and 20 minutes postinsertion and insertion duration (P = .53). Women's satisfaction, provider reported ease of insertion, and need for additional analgesia were significantly better among dinoprostone users (P < .001, < .001, and .02, respectively). Side effects and procedure complications were similar for the 2 groups.
CONCLUSION
Self-administered dinoprostone 3 mg vaginally 12 hours before a 52-mg LNG-IUD insertion in nulliparous adolescent and young women effectively reduced pain during insertion and increased women's satisfaction and ease of insertion reported by clinicians.",2020,"No significant differences were found between both groups regarding anticipated pain scores(P= 0.85), pain during speculum insertion and 20 minutes post-insertion and insertion duration(P=0.53).","['Nulliparous adolescents and young women aged 18-22 years', 'adolescents and young nulliparous women', 'nulliparous adolescent and young women', 'nulliparous adolescents and young women', 'Tertiary referral hospital']","['LNG-IUD insertion', 'placebo tablets vaginally', 'self-administered vaginal dinoprostone', 'dinoprostone', 'Dinoprostone', 'levonorgestrel-releasing intrauterine device insertion', 'dinoprostone 3 mg vaginally, and placebo', 'levonorgestrel intrauterine device (LNG-IUD) insertion']","['pain scores(P= 0.85), pain', 'Women satisfaction, provider reported ease of insertion and need for additional analgesia', 'Side effects and procedure complications', 'pain scores', 'pain scores during LNG-IUD insertion measured by visual analog scale (VAS', 'safety and efficacy', 'pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, women satisfaction score, need for additional analgesics, and side effects', 'pain']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C1131356', 'cui_str': 'Dinoprostone 3 MG'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517483', 'cui_str': '0.85 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0180964', 'cui_str': 'Tenaculum'}, {'cui': 'C0175729', 'cui_str': 'Uterine sound, device (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.8197,"No significant differences were found between both groups regarding anticipated pain scores(P= 0.85), pain during speculum insertion and 20 minutes post-insertion and insertion duration(P=0.53).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: ahmedsamy8233@gmail.com.'}, {'ForeName': 'Ahmed Said', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Fatma Faisal', 'Initials': 'FF', 'LastName': 'Darweesh', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nevein Kamal', 'Initials': 'NK', 'LastName': 'Ghamry', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2020.02.010']
341,30772404,Effects of an attachment-based intervention in infancy on children's autonomic regulation during middle childhood.,"The present study used a longitudinal randomized clinical trial to test whether an early intervention has causal effects on children's autonomic nervous system regulation. When children were infants, parents involved with Child Protective Services received Attachment and Biobehavioral Catch-up (ABC; N = 43), an intervention that promotes sensitive parenting, or a control intervention (N = 53). When children were 9 years old, children whose parents had received ABC exhibited higher respiratory sinus arrhythmia and lower heart rate at rest and during a parent-child interaction than children in the control group. Intervention effects were not detected for children's average skin conductance levels or for indices of autonomic reactivity. Results suggest that a parenting-focused early intervention impacted the development of children's autonomic regulation.",2019,Intervention effects were not detected for children's average skin conductance levels or for indices of autonomic reactivity.,"[""children's autonomic regulation during middle childhood"", ""children's autonomic nervous system regulation""]","['intervention that promotes sensitive parenting, or a control intervention', 'attachment-based intervention']","['respiratory sinus arrhythmia and lower heart rate', ""children's average skin conductance levels""]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}]","[{'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C3812870', 'cui_str': 'Respiratory Sinus Arrhythmia'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0308643,Intervention effects were not detected for children's average skin conductance levels or for indices of autonomic reactivity.,"[{'ForeName': 'Alexandra R', 'Initials': 'AR', 'LastName': 'Tabachnick', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, United States. Electronic address: atabachnick@psych.udel.edu.'}, {'ForeName': 'K Lee', 'Initials': 'KL', 'LastName': 'Raby', 'Affiliation': 'Department of Psychology, University of Utah, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Delaware, United States.'}]",Biological psychology,['10.1016/j.biopsycho.2019.01.006']
342,31523014,Effect of a Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control in India: A Cluster Randomized Controlled Trial.,"BACKGROUND
Eighty percent of premature mortality from cardiovascular disease occurs in low- and middle-income countries. Hypertension, diabetes, and smoking are the top risk factors causing this disease burden.
OBJECTIVES
The study aimed to test the hypothesis that utilizing community health workers (CHWs) to manage hypertension, diabetes and smoking in an integrated manner would lead to improved control of these conditions.
METHODS
This was a 2-year cluster (n = 12) randomized controlled trial of 3,556 adults (35 to 70 years of age) in a single town in India, who were screened at home for hypertension, diabetes, and smoking. Of these adults, 1,242 (35%) had at least 1 risk factor (hypertension = 650, diabetes = 317, smoking = 500) and were enrolled in the study. The intervention group had behavioral change communication through regular home visits from community health workers. The control group received usual care in the community. The primary outcomes were changes in systolic blood pressure, fasting blood glucose, and average number of cigarettes/bidis smoked daily among individuals with respective risk factors.
RESULTS
The mean ± SD change in systolic blood pressure at 2 years was -12.2 ± 19.5 mm Hg in the intervention group as compared with -6.4 ± 26.1 mm Hg in the control group, resulting in an adjusted difference of -8.9 mm Hg (95% confidence interval [CI]: -3.5 to -14.4 mm Hg; p = 0.001). The change in fasting blood glucose was -43.0 ± 83.5 mg/dl in the intervention group and -16.3 ± 77.2 mg/dl in the control group, leading to an adjusted difference of -21.3 mg/dl (95% CI: 18.4 to -61 mg/dl; p = 0.29). The change in mean number of cigarettes/bidis smoked was nonsignificant at +0.2 cigarettes/bidis (95% CI: 5.6 to -5.2 cigarettes/bidis; p = 0.93).
CONCLUSIONS
A population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking. (Study of a Community-Based Approach to Control Cardiovascular Risk Factors in India [SEHAT]; NCT02115711).",2019,"CONCLUSIONS
A population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking.","['India', 'Of these adults, 1,242 (35%) had at least 1 risk factor (hypertension\xa0= 650, diabetes\xa0= 317, smoking\xa0= 500) and were enrolled in the study', '3,556 adults (35 to 70 years of age) in a single town in India, who were screened at home for hypertension, diabetes, and smoking']","['usual care in the community', 'Community Health Worker-Based Approach to Integrated Cardiovascular Risk Factor Control', 'utilizing community health workers (CHWs']","['systolic blood pressure, fasting blood glucose, and average number of cigarettes/bidis smoked daily among individuals with respective risk factors', 'behavioral change communication', 'mean number of cigarettes/bidis smoked', 'fasting blood glucose', 'mean ± SD change in systolic blood pressure', 'systolic blood pressure']","[{'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C2984220', 'cui_str': 'Bidis Tobacco'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",3556.0,0.113259,"CONCLUSIONS
A population-based strategy of integrated risk factor management through community health workers led to improved systolic blood pressure in hypertension, an inconclusive effect on fasting blood glucose in diabetes, and no demonstrable effect on smoking.","[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Khetan', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA; SEHAT, Dalkhola, India. Electronic address: dradityakhetan@gmail.com.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zullo', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA; School of Public Health, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Anitha', 'Initials': 'A', 'LastName': 'Rani', 'Affiliation': 'Department of Community Medicine, Sri Ramachandra Medical College and Research Institute, Porur, India.'}, {'ForeName': 'Rishab', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'SEHAT, Dalkhola, India.'}, {'ForeName': 'Raghunandan', 'Initials': 'R', 'LastName': 'Purushothaman', 'Affiliation': 'SEHAT, Dalkhola, India.'}, {'ForeName': 'Navkaranbir S', 'Initials': 'NS', 'LastName': 'Bajaj', 'Affiliation': 'Division of Cardiovascular Disease, Department of Internal Medicine and Radiology, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'SEHAT, Dalkhola, India.'}, {'ForeName': 'Sri Krishna', 'Initials': 'SK', 'LastName': 'Madan Mohan', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Josephson', 'Affiliation': 'Harrington Heart & Vascular Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA; School of Public Health, Kent State University, Kent, OH, USA.'}]",Global heart,['10.1016/j.gheart.2019.08.003']
343,31526855,"Nitrite pharmacokinetics, safety and efficacy after experimental ventricular fibrillation cardiac arrest.","INTRODUCTION
Besides therapeutic hypothermia or targeted temperature management no novel therapies have been developed to improve outcomes of patients after cardiac arrest (CA). Recent studies suggest that nitrite reduces neurological damage after asphyxial CA. Nitrite is also implicated as a new mediator of remote post conditioning produced by tourniquet inflation-deflation, which is under active investigation in CA. However, little is known about brain penetration or pharmacokinetics (PK). Therefore, to define the optimal use of this agent, studies on the PK of nitrite in experimental ventricular fibrillation (VF) are needed. We tested the hypothesis that nitrite administered after resuscitation from VF is detectable in cerebrospinal fluid (CSF), brain and other organ tissues, produces no adverse hemodynamic effects, and improves neurologic outcome in rats.
METHODS
After return of spontaneous circulation (ROSC) of 5 min untreated VF, adult male Sprague-Dawley rats were given intravenous nitrite (8 μM, 0.13 mg/kg) or placebo as a 5 min infusion beginning at 5 min after CA. Additionally, sham groups with and without nitrite treatment were also studied. Whole blood nitrite levels were serially measured. After 15 min, CSF, brain, heart and liver tissue were collected. In a second series, using a randomized and blinded treatment protocol, rats were treated with nitrite or placebo after arrest. Neurological deficit scoring (NDS) was performed daily and eight days after resuscitation, fear conditioning testing (FCT) and brain histology were assessed.
RESULTS
In an initial series of experiments, rats (n = 21) were randomized to 4 groups: VF-CPR and nitrite therapy (n = 6), VF-CPR and placebo therapy (n = 5), sham (n = 5), or sham plus nitrite therapy (n = 5). Whole blood nitrite levels increased during drug infusion to 57.14 ± 10.82 μM at 11 min post-resuscitation time (1 min after dose completion) in the VF nitrite group vs. 0.94 ± 0.58 μM in the VF placebo group (p < 0.001). There was a significant difference between the treatment and placebo groups in nitrite levels in blood between 7.5 and 15 min after CPR start and between groups with respect to nitrite levels in CSF, brain, heart and liver. In a second series (n = 25 including 5 shams), 19 out of 20 animals survived until day 8. However, NDS, FCT and brain histology did not show any statistically significant difference between groups.
CONCLUSIONS
Nitrite, administered early after ROSC from VF, was shown to cross the blood brain barrier after a 5 min VF cardiac arrest. We characterized the PK of intravenous nitrite administration after VF and were able to demonstrate nitrite safety in this feasibility study.",2019,"There was a significant difference between the treatment and placebo groups in nitrite levels in blood between 7.5 and 15 min after CPR start and between groups with respect to nitrite levels in CSF, brain, heart and liver.","['rats', 'patients after cardiac arrest (CA', 'rats (n\u202f=\u202f21', 'After return of spontaneous circulation (ROSC) of 5\u202fmin untreated VF, adult male Sprague-Dawley rats']","['VF placebo', 'placebo', 'nitrite or placebo', 'VF-CPR and nitrite therapy (n\u202f=\u202f6), VF-CPR and placebo therapy (n\u202f=\u202f5), sham (n\u202f=\u202f5), or sham plus nitrite therapy', 'intravenous nitrite']","['neurological damage', 'CSF, brain, heart and liver tissue', 'Neurological deficit scoring (NDS', 'nitrite levels in blood', 'blood brain barrier', 'neurologic outcome', 'NDS, FCT and brain histology', 'Nitrite pharmacokinetics, safety and efficacy', 'nitrite levels in CSF, brain, heart and liver', 'Whole blood nitrite levels']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0034715', 'cui_str': 'Rats, Sprague-Dawley'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0736268', 'cui_str': 'Structure of parenchyma of liver'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0057753', 'cui_str': 'NDS'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0005854', 'cui_str': 'Hemato-Encephalic Barrier'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}]",25.0,0.0750492,"There was a significant difference between the treatment and placebo groups in nitrite levels in blood between 7.5 and 15 min after CPR start and between groups with respect to nitrite levels in CSF, brain, heart and liver.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Uray', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, PA, USA; Department of Emergency Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Philip E', 'Initials': 'PE', 'LastName': 'Empey', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA; Department of Pharmacy and Therapeutics, University of Pittsburgh, PA, USA.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Drabek', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA; Department of Anesthesiology, University of Pittsburgh School of Medicine, PA, USA.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Stezoski', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, PA, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Janesko-Feldman', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Jackson', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, PA, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Garman', 'Affiliation': 'Department of Pathology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Harborview Medical Center, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Kochanek', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, PA, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Dezfulian', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine, PA, USA; Department of Critical Care Medicine, University of Pittsburgh School of Medicine, PA, USA; Vascular Medicine Institute, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: dezfulianc@upmc.edu.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2019.09.003']
344,31539605,Brief English and Spanish Survey Detects Change in Response to Advance Care Planning Interventions.,"CONTEXT
The validated 82-item Advance Care Planning (ACP) Engagement Survey measures a broad range of ACP behaviors but is long.
OBJECTIVES
Determine whether shorter survey versions (55-item, 34-item, 15-item, 9-item, and 4-item versions) can detect similar change in response to two well-validated ACP interventions and provide practical effect size information.
METHODS
We assessed ACP engagement for 986 English- and Spanish-speaking adults in a randomized trial of PREPARE vs. an advance directive-only study arms. The survey was administered at baseline, one week, three months, six months, and 12 months. We calculated mean change scores from baseline to follow-up time points by study arm, intraclass correlation coefficients of change scores between the 82-item survey with shorter versions, and within-group and between-group effect sizes of the mean change scores.
RESULTS
Shorter survey versions were able to detect within-group and between-group changes at all time points. Within-group intraclass correlations of the 82-item to shorter versions were high (0.78-0.97), and the amount of between-group differences was comparable using all survey versions. Twelve-month within-group effect sizes ranged narrowly from 0.76 to 1.05 for different survey versions in the PREPARE arm and from 0.44 to 0.64 for the advance directive-only version. Between-group effect sizes ranged narrowly from 0.24 to 0.30 for different survey versions. Results were similar when stratified by English and Spanish speakers.
CONCLUSION
Shorter versions of the ACP Engagement Survey were able to detect within-group and between-group changes comparable with the 82-item version and can be useful for efficiently and effectively measuring ACP engagement in research and clinical settings.",2019,Twelve-month within-group effect sizes ranged narrowly from 0.76 to 1.05 for different Survey versions in the PREPARE arm and from 0.44 to 0.64 for the AD-only.,['986 English- and Spanish-speaking adults'],[],[],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0318599,Twelve-month within-group effect sizes ranged narrowly from 0.76 to 1.05 for different Survey versions in the PREPARE arm and from 0.44 to 0.64 for the AD-only.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; San Francisco Veterans Affairs Health Care System, San Francisco, California, USA. Electronic address: Ying.Shi@ucsf.edu.'}, {'ForeName': 'Deborah E', 'Initials': 'DE', 'LastName': 'Barnes', 'Affiliation': 'San Francisco Veterans Affairs Health Care System, San Francisco, California, USA; Department of Psychiatry, University of California, San Francisco, California, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boscardin', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'You', 'Affiliation': 'Departments of Medicine, and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Daren K', 'Initials': 'DK', 'LastName': 'Heyland', 'Affiliation': ""Department of Critical Care Medicine, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Aiesha M', 'Initials': 'AM', 'LastName': 'Volow', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, California, USA; San Francisco Veterans Affairs Health Care System, San Francisco, California, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2019.09.004']
345,29728704,The novel ghrelin receptor inverse agonist PF-5190457 administered with alcohol: preclinical safety experiments and a phase 1b human laboratory study.,"Rodent studies indicate that ghrelin receptor blockade reduces alcohol consumption. However, no ghrelin receptor blockers have been administered to heavy alcohol drinking individuals. Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects of a novel ghrelin receptor inverse agonist, PF-5190457, when co-administered with alcohol. We tested the effects of PF-5190457 combined with alcohol on locomotor activity, loss-of-righting reflex (a measure of alcohol sedative actions), and on blood PF-5190457 concentrations in rats. Then, we performed a single-blind, placebo-controlled, within-subject human study with PF-5190457 (placebo/0 mg b.i.d., 50 mg b.i.d., 100 mg b.i.d.). Twelve heavy drinkers during three identical visits completed an alcohol administration session, subjective assessments, and an alcohol cue-reactivity procedure, and gave blood samples for PK/PD testing. In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex. Alcohol did not affect blood PF-5190457 concentrations. In humans, all adverse events were mild or moderate and did not require discontinuation or dose reductions. Drug dose did not alter alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood during alcohol administration. Potential PD markers of PF-5190457 were acyl-to-total ghrelin ratio and insulin-like growth factor-1. PF-5190457 (100 mg b.i.d.) reduced alcohol craving during the cue-reactivity procedure. This study provides the first translational evidence of safety and tolerability of the ghrelin receptor inverse agonist PF-5190457 when co-administered with alcohol. PK/PD/behavioral findings support continued research of PF-5190457 as a potential pharmacological agent to treat alcohol use disorder.",2020,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","['rats', 'Twelve heavy drinkers']","['PF-5190457', 'placebo', 'PF-5190457 (placebo/0', 'ghrelin receptor inverse agonist', 'PF-5190457 combined with alcohol']","['reduced alcohol craving', 'alcohol consumption', 'locomotor activity, loss-of-righting reflex', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects', 'alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood', 'blood PF-5190457 concentrations', 'locomotor activity or loss-of-righting reflex']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0234156', 'cui_str': 'Righting Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005768'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}]",,0.0182118,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jenica D', 'Initials': 'JD', 'LastName': 'Tapocik', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mwlod', 'Initials': 'M', 'LastName': 'Ghareeb', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Dias', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Le', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA. lorenzo.leggio@nih.gov.'}]",Molecular psychiatry,['10.1038/s41380-018-0064-y']
346,32056951,Rostral anterior cingulate glutamate predicts response to subcallosal deep brain stimulation for resistant depression.,"BACKGROUND
Deep brain stimulation (DBS) of the subcallosal cingulate (SCC) provided benefit for treatment-resistant depression (TRD) in open-label studies but failed in a recent randomized sham-controlled trial. Informed patient selection, based on reliable biomarkers, is needed to optimize outcome. We investigated if rostral anterior cingulate (rACC) glutamate/glutamine concentration could serve as a potential biomarker of response.
METHODS
Sixteen adults with TRD (Major Depression; MDD = 14; Bipolar Depression; BD =2) underwent proton magnetic resonance spectroscopy using a short-echo proton spectroscopy with a voxel placed in the rACC, prior to DBS. Improvement in depression was assessed using the 17-item Hamilton Rating Scale for Depression (HDRS). Glutamate and glutamine concentrations at baseline in the rACC were examined in relation to clinical outcomes at six months.
RESULTS
Lower baseline glutamate predicted significant reduction in HDRS scores in all TRD patients (p = 0.018), and predicted both HDRS reduction (p = 0.002) and 6-month response outcome in MDD-TRD patients (p = 0.013). Neither baseline glutamine nor glutamine/glutamate ratio significantly related to outcome or symptom improvement.
LIMITATIONS
Our study was limited by sample size, though it is large for a DBS study. We measured from a single voxel in the brain, so we cannot be certain our findings are specific to the rACC.
CONCLUSIONS
These preliminary results suggest that baseline rACC-glutamate concentration could serve as a response-predictive biomarker for SCC-DBS, particularly in patients with resistant major depression. If our findings are replicated and validated, rACC-glutamate may provide a basis to prospectively select TRD patients to improve likelihood of response to SCC-DBS.",2020,"RESULTS
Lower baseline glutamate predicted significant reduction in HDRS scores in all TRD patients (p = 0.018), and predicted both HDRS reduction (p = 0.002) and 6-month response outcome in MDD-TRD patients (p = 0.013).","['patients with resistant major depression', 'Sixteen adults with TRD (Major Depression; MDD\xa0=\xa014; Bipolar Depression; BD =2) underwent']","['proton magnetic resonance spectroscopy using a short-echo proton spectroscopy with a voxel placed in the rACC, prior to DBS', 'rostral anterior cingulate (rACC) glutamate/glutamine concentration', 'Deep brain stimulation (DBS) of the subcallosal cingulate (SCC']","['Glutamate and glutamine concentrations', 'baseline glutamine nor glutamine/glutamate ratio', 'HDRS reduction', 'HDRS scores', '17-item Hamilton Rating Scale for Depression (HDRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}]","[{'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}]","[{'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}]",16.0,0.0519456,"RESULTS
Lower baseline glutamate predicted significant reduction in HDRS scores in all TRD patients (p = 0.018), and predicted both HDRS reduction (p = 0.002) and 6-month response outcome in MDD-TRD patients (p = 0.013).","[{'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: dlclark@ucalgary.ca.'}, {'ForeName': 'Frank P', 'Initials': 'FP', 'LastName': 'MacMaster', 'Affiliation': ""Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada; Department of Radiology, University of Calgary, Calgary, AB, Canada; Child and Adolescent Imaging Research (CAIR) Program, Alberta Children's Hospital, 2888 Shaganappi Trail NW, Calgary, Alberta, T3B 6A8 Canada. Electronic address: fmacmast@ucalgary.ca.""}, {'ForeName': 'Elliot C', 'Initials': 'EC', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada; Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Neuroscience Research Center, Berlin, Germany. Electronic address: elliot.c.brown@gmail.com.'}, {'ForeName': 'Zelma H T', 'Initials': 'ZHT', 'LastName': 'Kiss', 'Affiliation': 'Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: zkiss@ucalgary.ca.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Department of Psychiatry, University of Calgary, Calgary, AB, Canada; Department of Clinical Neuroscience, University of Calgary, AB, Canada; Mathison centre for Mental Health Research and Education, TRW building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N 4Z6 Canada; Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada. Electronic address: rramasub@ucalgary.ca.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.058']
347,32220916,"Combination Therapy With Canagliflozin Plus Liraglutide Exerts Additive Effect on Weight Loss, but Not on HbA 1c , in Patients With Type 2 Diabetes.","OBJECTIVE
To examine the effect of combination therapy with canagliflozin plus liraglutide on HbA 1c , endogenous glucose production (EGP), and body weight versus each therapy alone.
RESEARCH DESIGN AND METHODS
Forty-five patients with poorly controlled (HbA 1c 7-11%) type 2 diabetes mellitus (T2DM) on metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion, after which they were randomized to receive 1 ) liraglutide 1.2 mg/day (LIRA), 2 ) canagliflozin 100 mg/day (CANA), or 3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA) for 16 weeks. At 16 weeks, the EGP measurement was repeated.
RESULTS
The mean decrease from baseline to 16 weeks in HbA 1c was -1.67 ± 0.29% ( P = 0.0001), -0.89 ± 0.24% ( P = 0.002), and -1.44 ± 0.39% ( P = 0.004) in patients receiving CANA/LIRA, CANA, and LIRA, respectively. The decrease in body weight was -6.0 ± 0.8 kg ( P < 0.0001), -3.5 ± 0.5 kg ( P < 0.0001), and -1.9 ± 0.8 kg ( P = 0.03), respectively. CANA monotherapy caused a 9% increase in basal rate of EGP ( P < 0.05), which was accompanied by a 50% increase ( P < 0.05) in plasma glucagon-to-insulin ratio. LIRA monotherapy reduced plasma glucagon concentration and inhibited EGP. In CANA/LIRA-treated patients, EGP increased by 15% ( P < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
CONCLUSIONS
These results demonstrate that liraglutide failed to block the increase in EGP caused by canagliflozin despite blocking the rise in plasma glucagon and preventing the decrease in plasma insulin concentration caused by canagliflozin. The failure of liraglutide to prevent the increase in EGP caused by canagliflozin explains the lack of additive effect of these two agents on HbA 1c .",2020,"In CANA/LIRA-treated patients, EGP increased by 15% ( P < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","['Patients With Type 2 Diabetes', 'Forty-five patients with poorly controlled (HbA 1c 7-11%) type 2 diabetes mellitus (T2DM) on']","['Canagliflozin Plus Liraglutide', 'liraglutide', 'liraglutide 1.2 mg/day (LIRA); 2 ) canagliflozin 100 mg/day (CANA); or 3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA', 'canagliflozin plus liraglutide', 'metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion', 'LIRA monotherapy']","['Weight Loss', 'plasma glucagon concentration', 'HbA 1c , endogenous glucose production (EGP), and body weight', 'plasma insulin concentration', 'plasma insulin response', 'plasma glucagon-to-insulin ratio', 'body weight', 'basal rate of EGP', 'EGP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C3556805', 'cui_str': 'canagliflozin 100 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",45.0,0.0331542,"In CANA/LIRA-treated patients, EGP increased by 15% ( P < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","[{'ForeName': 'Ali Muhammed', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martinez', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Al-Jobori', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX albarado@uthscsa.edu.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}]",Diabetes care,['10.2337/dc18-2460']
348,31704437,"Protocol for a systematically-developed, phase I/II, single-blind randomized controlled trial of treadmill walking exercise training effects on cognition and brain function in persons with multiple sclerosis.","Slowed cognitive processing speed (CPS) is a common and debilitating consequence of multiple sclerosis (MS) that is notoriously difficult to treat. As such, we undertook a systematic line of research that indicated that supervised, progressive treadmill walking exercise (TMWX) training might improve CPS and brain functioning among fully-ambulatory persons with MS. The current study will be the first adequately-powered, single-blind randomized controlled trial (RCT) that examines the efficacy of 12-weeks of TMWX training compared with an active control condition on CPS, thalamocortical brain connectivity (based on resting-state fMRI), and exploratory functional outcomes in 88 fully-ambulatory persons with MS who present with slowed CPS. The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX. The active control condition involves supervised, minimal intensity, stretching-and-resistance exercise that will be delivered on the same frequency as the intervention condition. The primary study outcomes involve Symbol Digit Modalities Test performance (i.e., CPS) and fMRI-based measures of thalamocortical resting-state functional connectivity. Exploratory study outcomes involve measures of community participation, activities of daily living, quality of life, and functional mobility. All study outcomes will be administered before and after the 12-week study period by treatment-blinded assessors. If successful, the current study will provide the first Class I evidence for the effects of TMWX training as an approach for improving CPS and its neural correlate, and possibly mitigating the impact of slowed CPS on functional outcomes in MS.",2019,"The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX.","['persons with multiple sclerosis', '88 fully-ambulatory persons with MS who present with slowed CPS', 'fully-ambulatory persons with MS']","['supervised, progressive treadmill walking exercise (TMWX) training', 'Slowed cognitive processing speed (CPS', 'treadmill walking exercise training', 'TMWX training']","['Symbol Digit Modalities Test performance (i.e., CPS) and fMRI-based measures of thalamocortical resting-state functional connectivity', 'community participation, activities of daily living, quality of life, and functional mobility', 'CPS and brain functioning', 'cognition and brain function']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0009476', 'cui_str': 'Community Participation'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034380'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}]",88.0,0.0221623,"The intervention condition involves supervised, progressive TMWX training 3 times/week over 12-weeks; this initially involves 15-min of light-to-moderate intensity TMWX that progresses up to 40-min of vigorous intensity TMWX.","[{'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: sandroff@uab.edu.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Diggs', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Departments of Cell, Developmental, & Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Baird', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'C Danielle', 'Initials': 'CD', 'LastName': 'Jones', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Rinker', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Wylie', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105878']
349,31994720,Intravenous Endothelin-1 Infusion Does Not Induce Aura or Headache in Migraine Patients With Aura.,"OBJECTIVE
To investigate whether intravenously infused provokes migraine aura and migraine headache in migraine patients with aura.
BACKGROUND
Migraine with aura has been associated with endothelial dysfunction and increased stroke risk. The initiating mechanism of migraine aura symptoms is not known. Experimental provocation of migraine headache using vasoactive peptides has provided tremendous advances in the understanding of migraine pathophysiology but substances that can induce migraine aura have not been identified. Endothelin-1 (ET-1), an endogenous, potent vasoconstrictor peptide released from the vascular endothelium, has been proposed to trigger migraine aura. This hypothesis is based on reports of increased plasma ET-1 levels early during the migraine attacks and the observation that ET-1 applied to the cortical surface potently induces the cortical spreading depolarization, the underlying electrophysiological phenomenon of migraine aura, in animals. Further, endothelial damage due to, for example, carotid puncture and vascular pathology is known to trigger aura episodes.
METHODS
We investigated whether intravascular ET-1 would provoke migraine aura in patients. Using a two-way crossover, randomized, placebo-controlled, double-blind design, we infused high-dose (8 ng/kg/minutes for 20 minutes) intravenous ET-1 in patients with migraine with typical aura. The primary end-point was the difference in incidence of migraine aura between ET-1 and placebo. Experiments were carried out at a public tertiary headache center (Danish Headache Center, Rigshospitalet Glostrup, Denmark).
RESULTS
Fourteen patients received intravenous ET-1. No patients reported migraine aura symptoms or migraine headache during or up to 24 hours following the ET-1 infusion. Four patients reported mild to moderate headache only on the ET-1 day, 3 patients reported moderate headache on the placebo day, and 1 patient reported mild headache on both days. No serious adverse events occurred during or after infusion.
CONCLUSIONS
Provocation of migraine aura by procedures or conditions involving vascular irritation is unlikely to be mediated by ET-1.",2020,"No serious adverse events occurred during or after infusion.
","['Experiments were carried out at a public tertiary headache center (Danish Headache Center, Rigshospitalet Glostrup, Denmark', 'migraine patients with aura', 'Migraine Patients With Aura', 'patients with migraine with typical aura']","['Intravenous Endothelin-1 Infusion', 'Endothelin-1 (ET-1', 'placebo', 'intravascular ET-1', 'vasoactive peptides', 'intravenous ET-1']","['serious adverse events', 'incidence of migraine aura', 'migraine aura symptoms or migraine headache', 'moderate headache', 'mild headache', 'Aura or Headache']","[{'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C1735856', 'cui_str': 'Classical Migraine'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0154723', 'cui_str': 'Migraine with Aura'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0236018', 'cui_str': 'Aura'}]",,0.0362103,"No serious adverse events occurred during or after infusion.
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hougaard', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Samaira', 'Initials': 'S', 'LastName': 'Younis', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Ayata', 'Affiliation': 'Stroke Service, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Glostrup, Denmark.'}]",Headache,['10.1111/head.13753']
350,31778585,The life-enhancing alcohol-management program: Results from a 6-month nonrandomized controlled pilot study assessing a community based participatory research program in housing first.,"A 2-arm, 6-month, nonrandomized controlled pilot trial was conducted to test the initial effectiveness of the Life Enhancing Alcohol-management Program (LEAP) as an adjunct to Housing First (HF; e.g., permanent supportive housing) on alcohol and quality-of-life (QoL) outcomes. The LEAP entails resident-driven leadership opportunities, meaningful activities, and pathways to recovery aimed at reducing alcohol-related harm and improving QoL. Data analyses were conducted to test between- and within-subjects effects of the LEAP on self-reported alcohol and QoL outcomes among HF residents. At the 6-month follow up, between groups analysis revealed nonsignificant findings for alcohol quantity or alcohol-related harm (ps > 0.06); however, LEAP participants reported significantly more engagement in meaningful activities than control participants (p < .001), and within-subjects analyses indicated that high levels of LEAP programming engagement predicted significant reductions in alcohol quantity and alcohol-related harm (ps < 0.01). The LEAP was associated with increased engagement in meaningful activities, and greater involvement in the LEAP programming was associated with reduced alcohol use and alcohol-related harm. Planning is underway for a future, large-scale randomized controlled trial to establish the efficacy of this approach, its generalizability across HF programs, and potential mechanisms of action.",2020,"The LEAP was associated with increased engagement in meaningful activities, and greater involvement in the LEAP programming was associated with reduced alcohol use and alcohol-related harm.",[],['Life Enhancing Alcohol-management Program (LEAP'],"['meaningful activities', 'alcohol and quality-of-life (QoL) outcomes', 'alcohol quantity or alcohol-related harm', 'alcohol quantity and alcohol-related harm']",[],"[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0034380'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",,0.0238044,"The LEAP was associated with increased engagement in meaningful activities, and greater involvement in the LEAP programming was associated with reduced alcohol use and alcohol-related harm.","[{'ForeName': 'Seema L', 'Initials': 'SL', 'LastName': 'Clifasefi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington-Harborview Medical Center, Seattle, Washington.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington-Harborview Medical Center, Seattle, Washington.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Downtown Emergency Service Center, Seattle, Washington.'}]",Journal of community psychology,['10.1002/jcop.22291']
351,32216911,Withdrawal of Neurohumoral Blockade After Cardiac Resynchronization Therapy.,"BACKGROUND
The necessity of neurohumoral blockers in patients with heart failure who demonstrate normalized ejection fractions after cardiac resynchronization therapy remains unclear.
OBJECTIVES
The aim of this study was to investigate the feasibility and safety of neurohumoral blocker withdrawal in patients with normalized ejection fractions after cardiac resynchronization therapy.
METHODS
In this prospective, open-label, randomized controlled pilot trial with a 2 × 2 factorial design, subjects were randomized to withdrawal of renin-angiotensin-aldosterone system inhibitors and/or beta-blockers versus continuation of treatment. The primary endpoint was a recurrence of negative remodeling, defined as an increase in left ventricular end-systolic volume index of >15% at 24 months. The secondary endpoint was a composite safety endpoint of all-cause mortality, heart failure-related hospitalizations, and incidence of sustained ventricular arrhythmias at 24 months.
RESULTS
Eighty subjects were consecutively enrolled and randomized among 4 groups (continuation of neurohumoral blocker therapy, n = 20; withdrawal of renin-angiotensin-aldosterone system inhibitors, n = 20; withdrawal of beta-blockers, n = 20; and withdrawal of renin-angiotensin-aldosterone system inhibitors and beta-blockers, n = 20). Of the 80 subjects, 6 (7.5%) met the primary and 4 (5%) the secondary endpoint. However, re-initiation of neurohumoral blockers occurred in 17 subjects because of hypertension or supraventricular arrhythmias.
CONCLUSIONS
The incidence of the primary and secondary endpoints over a follow-up period of 2 years was low in both the control group and in the groups in which neurohumoral blockers were discontinued. However, neurohumoral blocker withdrawal was hampered by cardiac comorbidities. (Systematic Withdrawal of Neurohumoral Blocker Therapy in Optimally Responding CRT Patients [STOP-CRT]; NCT02200822).",2020,The incidence of the primary and secondary endpoints over a follow-up period of 2 years was low in both the control group and in the groups in which neurohumoral blockers were discontinued.,"['patients with heart failure who demonstrate normalized ejection fractions after cardiac resynchronization therapy remains unclear', 'Eighty subjects', 'patients with normalized ejection fractions after cardiac resynchronization therapy', '17 subjects because of hypertension or supraventricular arrhythmias']","['Neurohumoral Blockade', 'neurohumoral blocker withdrawal', 'neurohumoral blocker therapy, n\xa0=\xa020; withdrawal of renin-angiotensin-aldosterone system inhibitors, n\xa0=\xa020; withdrawal of beta-blockers, n\xa0=\xa020; and withdrawal of renin-angiotensin-aldosterone system inhibitors and beta-blockers, n\xa0=\xa020', 'renin-angiotensin-aldosterone system inhibitors and/or beta-blockers', 'neurohumoral blockers']","['recurrence of negative remodeling, defined as an increase in left ventricular end-systolic volume index', 'composite safety endpoint of all-cause mortality, heart failure-related hospitalizations, and incidence of sustained ventricular arrhythmias at 24\xa0months', 'feasibility and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",80.0,0.0318763,The incidence of the primary and secondary endpoints over a follow-up period of 2 years was low in both the control group and in the groups in which neurohumoral blockers were discontinued.,"[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Nijst', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Doctoral School for Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium. Electronic address: https://twitter.com/petra_nijst.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Martens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Dauw', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Doctoral School for Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Philippe B', 'Initials': 'PB', 'LastName': 'Bertrand', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Penders', 'Affiliation': 'Department of Laboratory Medicine, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Bruckers', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Voros', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Willems', 'Affiliation': 'Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter M', 'Initials': 'PM', 'LastName': 'Vandervoort', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Doctoral School for Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Dupont', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Mullens', 'Affiliation': 'Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; Biomedical Research Institute, Faculty of Medicine and Life Sciences, Hasselt University, Diepenbeek, Belgium. Electronic address: wilfried.mullens@zol.be.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.01.040']
352,32221668,Trekstock RENEW: evaluation of a 12-week exercise referral programme for young adult cancer survivors delivered by a cancer charity.,"PURPOSE
To evaluate the uptake and effect of RENEW, a 12-week exercise referral programme for young adult cancer survivors delivered by Trekstock, a UK-based cancer charity.
METHODS
The RENEW programme provides one-to-one individually tailored support from a level-4 cancer-rehabilitation-qualified gym instructor, free gym membership and access to information resources online. Objective and self-report data on cardiorespiratory function, strength, body composition, fatigue, sleep quality and general health-related quality of life (HRQoL) was collected from participants before the programme (week 0), immediately after (week 12) and 1 month later (week 16).
RESULTS
Forty-eight young adults (83% female; mean age, 29 years) with a history of cancer took part within the 12-week programme and completed the evaluation measures. Physical activity (PA) levels significantly increased following the programme and remained raised at follow-up. Improvements in physical function were significant: peak expiratory flow (mean change, 30.96, p = 0.003), sit-and-reach test (mean change, 6.55 ± 4.54, p < 0.0001), and 6-mine-walk test (mean change, 0.12 ± 0.04, p < 0.0001). No significant changes in BMI, weight or muscle mass were observed. Improvements in fatigue, sleep and HRQoL were observed across the programme and at follow-up (mean change, weeks 0-16; 8.04 ± 1.49 p < 0.01; 1.05 ± 0.49 p < 0.05; and - 0.9 ± 0.46 p = 0.051, respectively). Changes in self-efficacy to exercise and motivations to exercise were not observed at 12 weeks or at follow-up.
CONCLUSIONS
Results suggest that the RENEW exercise referral programme has a positive impact upon some domains of physical function and well-being among young adult cancer survivors.
IMPLICATION FOR CANCER SURVIVORS
Exercise referral programmes delivered by charity organisations are one means by which PA behaviour change support may be widely disseminated to young adult cancer survivors. Health professionals and charitable bodies specialising in the care of young adults with cancer should look to address factors which prevent engagement and uptake of 'real-world' PA interventions such as the RENEW programme.",2020,"Improvements in physical function were significant: peak expiratory flow (mean change, 30.96, p = 0.003), sit-and-reach test (mean change, 6.55 ± 4.54, p < 0.0001), and 6-mine-walk test (mean change, 0.12 ± 0.04, p < 0.0001).","['Forty-eight young adults (83% female; mean age, 29\xa0years) with a history of cancer took part within the 12-week programme and completed the evaluation measures', 'young adult cancer survivors', 'young adult cancer survivors delivered by a cancer charity', 'young adult cancer survivors delivered by Trekstock, a UK-based cancer charity', 'young adults with cancer']",['exercise referral programme'],"['cardiorespiratory function, strength, body composition, fatigue, sleep quality and general health-related quality of life (HRQoL', 'fatigue, sleep and HRQoL', 'peak expiratory flow', 'BMI, weight or muscle mass', 'Physical activity (PA) levels']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0455471', 'cui_str': 'H/O: malignant neoplasm'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007962', 'cui_str': 'Charities'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",48.0,0.0199571,"Improvements in physical function were significant: peak expiratory flow (mean change, 30.96, p = 0.003), sit-and-reach test (mean change, 6.55 ± 4.54, p < 0.0001), and 6-mine-walk test (mean change, 0.12 ± 0.04, p < 0.0001).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pugh', 'Affiliation': 'Centre for Sports & Exercise Medicine, William Harvey Research Institute, School of Medicine & Dentistry, Queen Mary University of London, London, UK. g.pugh@qmul.ac.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Below', 'Affiliation': 'Centre for Sports & Exercise Medicine, William Harvey Research Institute, School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'Department of Behavioural Science & Health, Institute of Epidemiology & Health Care, University College London, London, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Trekstock, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Epstone', 'Affiliation': 'Trekstock, London, UK.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05373-5']
353,32220917,"Effects of Low-Energy Diet or Exercise on Cardiovascular Function in Working-Age Adults With Type 2 Diabetes: A Prospective, Randomized, Open-Label, Blinded End Point Trial.","OBJECTIVE
To confirm the presence of subclinical cardiovascular dysfunction in working-age adults with type 2 diabetes (T2D) and determine whether this is improved by a low-energy meal replacement diet (MRP) or exercise training.
RESEARCH DESIGN AND METHODS
This article reports on a prospective, randomized, open-label, blinded end point trial with nested case-control study. Asymptomatic younger adults with T2D were randomized 1:1:1 to a 12-week intervention of 1 ) routine care, 2 ) supervised aerobic exercise training, or 3 ) a low-energy (∼810 kcal/day) MRP. Participants underwent echocardiography, cardiopulmonary exercise testing, and cardiac magnetic resonance (CMR) at baseline and 12 weeks. The primary outcome was change in left ventricular (LV) peak early diastolic strain rate (PEDSR) as measured by CMR. Healthy volunteers were enrolled for baseline case-control comparison.
RESULTS
Eighty-seven participants with T2D (age 51 ± 7 years, HbA 1c 7.3 ± 1.1%) and 36 matched control participants were included. At baseline, those with T2D had evidence of diastolic dysfunction (PEDSR 1.01 ± 0.19 vs. 1.10 ± 0.16 s -1 , P = 0.02) compared with control participants. Seventy-six participants with T2D completed the trial (30 routine care, 22 exercise, and 24 MRP). The MRP arm lost 13 kg in weight and had improved blood pressure, glycemia, LV mass/volume, and aortic stiffness. The exercise arm had negligible weight loss but increased exercise capacity. PEDSR increased in the exercise arm versus routine care (β = 0.132, P = 0.002) but did not improve with the MRP (β = 0.016, P = 0.731).
CONCLUSIONS
In asymptomatic working-age adults with T2D, exercise training improved diastolic function. Despite beneficial effects of weight loss on glycemic control, concentric LV remodeling, and aortic stiffness, a low-energy MRP did not improve diastolic function.",2020,"PEDSR increased in the exercise arm versus routine care (β = 0.132, P = 0.002) but did not improve with the MRP (β = 0.016, P = 0.731).
","['asymptomatic working-age adults with T2D', 'Asymptomatic younger adults with T2D', '2 Diabetes', 'Working-Age Adults With Type', 'Healthy volunteers were enrolled for baseline case-control comparison', 'Eighty-seven participants with T2D (age 51 ± 7 years, HbA 1c 7.3 ± 1.1%) and 36 matched control participants were included', 'working-age adults with type 2 diabetes (T2D', 'Seventy-six participants with T2D completed the trial (30 routine care, 22 exercise, and 24 MRP']","['12-week intervention of 1 ) routine care, 2 ) supervised aerobic exercise training, or 3 ) a low-energy (∼810 kcal/day) MRP', 'low-energy meal replacement diet (MRP) or exercise training', 'Low-Energy Diet or Exercise', 'exercise training', 'echocardiography, cardiopulmonary exercise testing, and cardiac magnetic resonance (CMR']","['diastolic dysfunction', 'Cardiovascular Function', 'PEDSR', 'change in left ventricular (LV) peak early diastolic strain rate (PEDSR', 'diastolic function', 'glycemic control, concentric LV remodeling, and aortic stiffness', 'negligible weight loss', 'blood pressure, glycemia, LV mass/volume, and aortic stiffness']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C1701620', 'cui_str': 'mercaptopropionyl-phenylalanyl-cyclohexylalanyl-cyclohexylalanyl-arginyl-lysyl-prolyl-asparaginyl-aspartyl-lysinamide'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C3654008', 'cui_str': 'Low-energy diets'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction (finding)'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0332269', 'cui_str': 'Negligible (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",87.0,0.0736891,"PEDSR increased in the exercise arm versus routine care (β = 0.132, P = 0.002) but did not improve with the MRP (β = 0.016, P = 0.731).
","[{'ForeName': 'Gaurav S', 'Initials': 'GS', 'LastName': 'Gulsin', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Swarbrick', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Athithan', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Emer M', 'Initials': 'EM', 'LastName': 'Brady', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Henson', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Baldry', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Argyridou', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Nishal B', 'Initials': 'NB', 'LastName': 'Jaicim', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Squire', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Walters', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, U.K.'}, {'ForeName': 'Anna-Marie', 'Initials': 'AM', 'LastName': 'Marsh', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'McAdam', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Kelly S', 'Initials': 'KS', 'LastName': 'Parke', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Biglands', 'Affiliation': 'NIHR Leeds Biomedical Research Centre, Leeds, U.K.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester and the NIHR Leicester Biomedical Research Centre, Leicester, U.K.'}, {'ForeName': 'Gerry P', 'Initials': 'GP', 'LastName': 'McCann', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester and the National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, Leicester, U.K. gpm12@leicester.ac.uk.'}]",Diabetes care,['10.2337/dc20-0129']
354,32220099,Opioid-induced Euphoria Among Emergency Department Patients With Acute Severe Pain: An Analysis of Data From a Randomized Trial.,"BACKGROUND
Parenteral opioids are commonly used to treat acute severe pain. We measured pleasurable sensations in patients administered intravenous analgesics to determine if these sensations were associated with receipt of an opioid, after controlling for relief of pain. Pleasurable sensations not accounted for by relief of pain were considered opioid-induced euphoria.
METHODS
These data were from a randomized study of 1 mg of hydromorphone versus 120 mg of lidocaine for abdominal pain. To assess euphoria, participants were asked to provide a 0 to 10 response to each of these questions: 1) How good did the medication make you feel? 2) How high did the medication make you feel? and 3) How happy did the medication make you feel? Pain at baseline and 30 minutes was also measured on a 0 to 10 scale. To determine the relative importance of pain relief versus medication type, we built three linear regression models in which each euphoria question was the dependent variable and pain relief, medication type, and medication-induced side effects were the independent variables.
RESULTS
Seventy-seven patients received lidocaine and 77 hydromorphone. Hydromorphone patients reported greater pain improvement than lidocaine patients (mean difference = 1.5, 95% confidence interval [CI] = 0.6 to 2.3) and higher scores on all three euphoria questions (""feeling good"" difference = 1.9, 95% CI = 0.8 to 3.0; ""feeling high"" difference = 1.5, 95% CI = 0.4 to 2.7; ""feeling happy"" difference = 1.7, 95% CI = 0.6 to 2.8). In the regression models, hydromorphone administration (β-coefficient = 0.16, p = 0.03) and pain relief (β-coefficient = 0.45, p < 0.01) were both associated with ""feeling good."" ""Feeling high"" and ""feeling happy"" were associated with pain improvement (p < 0.01) but not with hydromorphone administration (p = 0.07 for ""high"" and p = 0.06 for ""happy""). Medication-induced side effects were not associated with these measures of euphoria.
CONCLUSION
Among emergency department patients with acute pain, hydromorphone-induced euphoria, though measurable, was generally less important for patients than relief of pain.",2020,"Hydromorphone patients reported greater pain improvement than lidocaine patients (mean difference = 1.5, 95% confidence interval [CI] = 0.6 to 2.3) and higher scores on all three euphoria questions (""feeling good"" difference = 1.9, 95% CI = 0.8 to 3.0; ""feeling high"" difference = 1.5, 95% CI = 0.4 to 2.7; ""feeling happy"" difference = 1.7, 95% CI = 0.6 to 2.8).","['emergency department patients with acute pain', 'Emergency Department Patients With Acute Severe Pain']","['Hydromorphone', 'Opioid-induced Euphoria', 'hydromorphone', 'lidocaine']","['pain improvement', 'feeling good', 'euphoria questions', 'pleasurable sensations', 'Pain', 'pain relief', 'euphoria']","[{'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]","[{'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0235146', 'cui_str': 'Euphoria'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",,0.237047,"Hydromorphone patients reported greater pain improvement than lidocaine patients (mean difference = 1.5, 95% confidence interval [CI] = 0.6 to 2.3) and higher scores on all three euphoria questions (""feeling good"" difference = 1.9, 95% CI = 0.8 to 3.0; ""feeling high"" difference = 1.5, 95% CI = 0.4 to 2.7; ""feeling happy"" difference = 1.7, 95% CI = 0.6 to 2.8).","[{'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Abril Ochoa', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Farnia', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'and the, Medical College, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Polly E', 'Initials': 'PE', 'LastName': 'Bijur', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13946']
355,32212829,Stent performance in palliative transhepatic treatment of malignant biliary obstruction: a randomized study comparing covered versus uncovered stents.,"BACKGROUND
Considering the limitations in both uncovered self-expandable metallic stents (USEMS) and covered self-expandable metallic stents (CSEMS), it is difficult to make a general recommendation for their application in percutaneous decompression of malignant biliary obstruction (MBO).
PURPOSE
To compare percutaneous transhepatic CSEMSs versus USEMSs for the palliative treatment of MBO in terms of technical success, clinical success, stent patency, patient survival, complications, and stent dysfunction.
MATERIAL AND METHODS
This prospective randomized study included 66 patients with unresectable MBO. CSEMSs were inserted in 31 patients (26 men, 5 women; mean age = 63.8 ± 7.96 years) and USEMSs were inserted in 35 patients (26 men, 9 women; mean age = 62.3 ± 11.7 years).
RESULTS
Mean primary stent patency duration was 138 ± 92.7 days in CSEMSs versus 150 ± 77.9 days in USEMSs ( P = 0.578). Tumor overgrowth occurred exclusively in one patient with CSEMS ( P = 0.470) and tumor ingrowth exclusively in two patients with USEMS ( P = 0.494). Stent migration occurred in two patients with CSEMSs versus one patient with USEMSs ( P = 0.579). Hemobilia occurred in five patients with CSEMSs versus three patients with USEMSs while bile leakage occurred in one patient in each group despite the larger introducer sheath caliber with CSEMSs (9 F vs. 6-7 F). There was no significant difference regarding patient survival ( P = 0.969).
CONCLUSION
In our cohort of patients with rather poor life expectancy, there was no significant difference between covered and uncovered stents for the palliative treatment of MBO. However, considering the higher cost of CSEMs and the larger introducer diameter necessary for their placement, USEMSs can be preferred.",2020,,['malignant biliary obstruction'],[],['Stent performance'],"[{'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",[],"[{'cui': 'C0038257', 'cui_str': 'Stents'}]",,0.0666687,,"[{'ForeName': 'Aboelyazid', 'Initials': 'A', 'LastName': 'Elkilany', 'Affiliation': 'Department of Diagnostic Medical Imaging and Interventional Radiology, National Liver Institute, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alwarraky', 'Affiliation': 'Department of Diagnostic Medical Imaging and Interventional Radiology, National Liver Institute, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Geisel', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Maaly', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Denecke', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Leipzig University Hospital, Leipzig, Germany.'}]","Acta radiologica (Stockholm, Sweden : 1987)",['10.1177/0284185120911187']
356,32213044,High-Intensity 10-s Work: 5-s Recovery Intermittent Training Improves Anaerobic and Aerobic Performances.,"Purpose and Methods : To compare the effects of a set of 12-30 min, maximal effort, constant load cycle bouts (HICT) to 12 short work: shorter rest (10 s: 5 s) interval sessions (INT) of similar duration and effort, performed on alternate days over 4 weeks, on performance and V̇O 2 l . min -1 . INT sessions consisted of repeated cycles of 10 s work followed by 5 s of recovery for 30 min. Fourteen male athletes (83 kg ± 6, 24year ± 2) were randomly assigned to HICT (n = 7) or INT (n = 7) training. Pre- and post-power output (PO), V̇O 2 and V̇O 2peak , during 60s, 3 min, and ramp (RAMP) tests were collected Results : Between group comparisons showed increased mean PO, pre- to post-INT training ( p = .026) over the last min of the 3-min test whereas PO post-HICT training declined. INT showed greater training effects on the 60 s test than HCIT (INT 506 ± 45 to 535 ± 55 W; p = .002, Cd = .57; HCIT 513 ± 78 to 548 ± 83 W; p = .02, Cd = 27). RAMP peak PO and V̇O 2peak increased within both groups (INT 341 ± 63 to 370 ± 48 W, p = .002, Cd = 0.52; HICT 332 ± 45 to 353 ± 44 W, p = .006, Cd = .53; 3.73 ± 0.68 to 4.06 ± 0.63 L·min -1 , p = .001, Cd = .50; 3.75 ± 0.62 to 4.09 ± 0.52 L·min -1 , p = .002, Cd = .59). Conclusion(s) : These results show that utilizing this novel short work: shorter rest (10 s: 5 s) interval training paradigm will elicit better performances in moderate duration performances compared to continuous training of the same duration, effort, and frequency.",2020,"Between group comparisons showed increased mean PO, pre- to post-INT training ( p = .026) over the last min of the 3-min test whereas PO post-HICT training declined.","['Fourteen male athletes (83 kg ± 6, 24year ± 2', 'HCIT 513 ± 78 to 548 ± 83 W', 'Conclusion(s']",['HICT'],"['mean PO, pre- to post-INT training', 'RAMP peak PO and V̇O 2peak', 'Anaerobic and Aerobic Performances', 'Pre- and post-power output (PO), V̇O 2 and V̇O 2peak ']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}]",14.0,0.0302246,"Between group comparisons showed increased mean PO, pre- to post-INT training ( p = .026) over the last min of the 3-min test whereas PO post-HICT training declined.","[{'ForeName': 'Glen R', 'Initials': 'GR', 'LastName': 'Belfry', 'Affiliation': 'The University of Western Ontario.'}, {'ForeName': 'Don H', 'Initials': 'DH', 'LastName': 'Paterson', 'Affiliation': 'The University of Western Ontario.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Thomas', 'Affiliation': 'University of Toronto.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1696928']
357,31943197,Use of Amitriptyline in the Treatment of Headache After Traumatic Brain Injury: Lessons Learned From a Clinical Trial.,"OBJECTIVES
The primary outcome of this study was to assess the efficacy and safety of preventive treatment with amitriptyline on headache frequency and severity after mild traumatic brain injury (mTBI).
BACKGROUND
Despite the fact that headache is the most common and persistent physical symptom after TBI, there has been little research on the longitudinal course or pharmacologic treatment of this disorder. Of those who have headache after injury, about 60% continue to complain of headache at 3 months post injury, with higher levels of disability than those without headache. There have been no prospective, randomized, controlled trials of a pharmacologic agent for headache after TBI. Additionally, a brain-injured population may be more susceptible to side effects of medication.
DESIGN
This is a single-center phase II trial of amitriptyline to prevent persistent headache after an mTBI. Medication dose was gradually increased from 10 to 50 mg daily.
RESULTS
Fifty participants were enrolled and 33 who completed the 90-day assessment were included in the final analysis. In order to detect a possible cognitive impact of the study drug, 24 participants were randomly assigned to start amitriptyline immediately after study enrollment and 26 were assigned to start 30 days after enrollment. Forty-nine percent (18/37) of those assigned to take medication took none throughout the study period, with less compliance in younger participants with mean ages of 32.7 in those who did not take any medication, 33.4 who were less than 80% compliant, and 42.3 who were compliant (P = .013). Compliance in keeping a daily headache diary was low, with 29/50 participants (58%) meeting daily entry completion, and only 10 participants maintaining 100% diary completion. No differences were found between those who started medication immediately vs at day 30 in headache frequency or severity.
CONCLUSIONS
While headache is the most common symptom following mTBI, current evidence does not support a specific treatment. No differences were noted in headache frequency compared to our prior study. However, the current sample had significantly lower headache severity (15% vs 36% with pain rating of 6 or above, P = .015) compared to our prior study. Our current study was not able to determine whether there is any benefit for the use of amitriptyline as a headache preventive because of difficulty with study recruitment and compliance. The challenges with recruitment and retention in the mTBI population were instructive, and future research in this area will need to identify strategies to improve recruitment, diary compliance, and medication adherence in this population.",2020,"No differences were found between those who started medication immediately vs at day 30 in headache frequency or severity.
","['Fifty participants were enrolled and 33 who completed the 90-day assessment were included in the final analysis', 'After Traumatic Brain Injury', '24 participants', 'after mild traumatic brain injury (mTBI']","['Amitriptyline', 'amitriptyline']","['headache frequency and severity', 'complain of headache', 'efficacy and safety', 'headache frequency or severity', 'headache severity', 'headache frequency', 'Headache']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}]","[{'cui': 'C0002600', 'cui_str': 'Amitriptyline'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.117002,"No differences were found between those who started medication immediately vs at day 30 in headache frequency or severity.
","[{'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Hurwitz', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Lucas', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kathleen R', 'Initials': 'KR', 'LastName': 'Bell', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Temkin', 'Affiliation': 'Department of Neurological Surgery, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sureyya', 'Initials': 'S', 'LastName': 'Dikmen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Hoffman', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}]",Headache,['10.1111/head.13748']
358,31944310,Sumatriptan Does Not Antagonize CGRP-Induced Symptoms in Healthy Volunteers.,"OBJECTIVE
Previous attempts to develop a pragmatic human model for testing new anti-migraine drugs, have failed. Calcitonin gene-related peptide (CGRP) induces a mild headache in healthy volunteers and migraine-like headache in migraine patients. The induced headache must respond to already established migraine treatment for validation. Thus, the objective of the study was to test the effect of sumatriptan against CGRP-induced symptoms in an attempt to validate CGRP-induced headache as a model for drug testing.
METHODS
Thirty healthy volunteers were recruited to receive a 2-hour infusion of CGRP on 2 separate days. The participants were pretreated with sumatriptan 1 day and with placebo the other day in a randomized double-blind cross-over fashion. During the infusion, a questionnaire about headache and side effects was administered. Electrocardiography, heart rate, blood pressure, dermal blood flow, and diameter of peripheral arteries were monitored during the infusion. Participants were carefully instructed to fill out a headache questionnaire at home until 12 hours after the infusion start. Primary endpoints are difference between the sumatriptan day and the placebo day in area under the headache score curve (AUC) 0-2 hours after infusion start and in headache intensity 2 hours after infusion start. The study was conducted at the Danish Headache Center in Glostrup, Denmark.
RESULTS
CGRP-induced headache in 86% (25/29) of the participants on the sumatriptan day and in 96% (28/29) of the participants on the placebo day. There was no difference in AUC headache, 0-2 hours between the days (P = .794). There was a statistically significant decrease in mean atrial pressure (MAP) over time on both days with a16.2% reduction on the sumatriptan day and a 14.8% reduction on the placebo day (P < .001) and a statistically significant increase in heart rate (HR) over time on both days (from mean 57.5 at baseline to mean 105.4 at 120 minutes on the sumatriptan day and from mean 60.2 at baseline to 105.8 at 120 minutes on the placebo day, P < .001). The diameter of peripheral arteries increased statistically significant on both days (P < .001).
CONCLUSION
Sumatriptan does not influence headache score, accompanying symptoms or other symptoms induced by CGRP. Furthermore, a 2-hour CGRP infusion causes a wide range of side effects and does not induce more headache than the usual 20-minute infusion. Thus, the prolonged infusion of CGRP in healthy volunteers is not a valid and pragmatic model for testing new anti-migraine drugs.",2020,Calcitonin gene-related peptide (CGRP) induces a mild headache in healthy volunteers and migraine-like headache in migraine patients.,"['Healthy Volunteers', 'healthy volunteers and migraine-like headache in migraine patients', 'Danish Headache Center in Glostrup, Denmark', 'healthy volunteers', 'Thirty healthy volunteers']","['sumatriptan 1 day and with placebo', 'sumatriptan', 'Calcitonin gene-related peptide (CGRP', 'CGRP', 'Sumatriptan']","['mean atrial pressure (MAP', 'Electrocardiography, heart rate, blood pressure, dermal blood flow, and diameter of peripheral arteries', 'AUC headache', 'diameter of peripheral arteries', 'placebo day in area under the headache score curve (AUC) 0-2\xa0hours after infusion start and in headache intensity', 'headache', 'headache score', 'heart rate (HR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin Gene-Related Peptide'}]","[{'cui': 'C3854604', 'cui_str': 'Mean atrial pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",30.0,0.170592,Calcitonin gene-related peptide (CGRP) induces a mild headache in healthy volunteers and migraine-like headache in migraine patients.,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Falkenberg', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rønde Bjerg', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Yamani', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Olesen', 'Affiliation': 'Danish Headache Centre, Department of Neurology, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark.'}]",Headache,['10.1111/head.13747']
359,32090783,Effectiveness of the Thinking Healthy Programme for perinatal depression delivered through peers: Pooled analysis of two randomized controlled trials in India and Pakistan.,"BACKGROUND
The Thinking Healthy Programme (THP) is recommended to treat perinatal depression in resource-limited settings, but scale-up is hampered by a paucity of community health workers. THP was adapted for peer-delivery (THPP) and evaluated in two randomized controlled trials in India and Pakistan. Our aim was to estimate the effectiveness of THPP on maternal outcomes across these two settings, and evaluate effect-modification by country and other pre-defined covariates.
METHODS
Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to THPP plus enhanced usual care (EUC) or EUC-only. Primary outcomes were symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth. Secondary outcomes included further measures of depression, disability and social support at 3 and 6 months post-childbirth.
RESULTS
Among 850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up. Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only. There was a greater intervention effect on remission among women with short chronicity of depression, and those primiparous. There were beneficial intervention effects across multiple secondary outcomes.
LIMITATIONS
The trials were not powered to assess effect-modifications. 10-20% of participants were missing outcome data.
CONCLUSIONS
This pooled analysis demonstrates the effectiveness, acceptability and feasibility of THPP, which can be scaled-up within a stepped-care approach by engaging with the existing health care systems and the communities to address the treatment gap for perinatal depression in resource-limited settings.",2020,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","['perinatal depression delivered through peers', 'Participants were pregnant women aged≥18 years with depression (Patient Health Questionnaire (PHQ-9) score≥10), randomized to', '850 women (280 India; 570 Pakistan), 704 (83%) attended 6-month follow-up']","['THPP plus enhanced usual care (EUC) or EUC-only', 'THPP', 'Thinking Healthy Programme (THP', 'India and Pakistan', 'THP', 'Thinking Healthy Programme']","['lower symptom severity (PHQ-9 score', 'symptom severity and remission (PHQ-9 score<5) 6 months post-childbirth', 'depression, disability and social support at 3 and 6 months post-childbirth']","[{'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0060462', 'cui_str': 'flopropione'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0217641', 'cui_str': '4-Pyrimidinecarboxylic acid, 1,4,5,6-tetrahydro-2-methyl-'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0037438'}]",850.0,0.199711,"Participants in the intervention arm had lower symptom severity (PHQ-9 score adjusted mean difference -0.78 (95% confidence interval -1.47,-0.09)) and higher odds of remission (adjusted odds ratio 1.35 (1.02,1.78)) versus EUC-only.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: fiona.vanobberghen@swisstph.ch.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Fuhr', 'Affiliation': 'Faculty of Public Health and Policy, Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Siham', 'Initials': 'S', 'LastName': 'Sikander', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan; Health Services Academy, Islamabad, Pakistan.'}, {'ForeName': 'Ejma', 'Initials': 'E', 'LastName': 'Afonso', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ikhlaq', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Najia', 'Initials': 'N', 'LastName': 'Atif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Tayyaba', 'Initials': 'T', 'LastName': 'Bibi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Bilal', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Aveena', 'Initials': 'A', 'LastName': 'De Sa', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Ethel', 'Initials': 'E', 'LastName': ""D'Souza"", 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Akankasha', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Korgaonkar', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Revathi', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Lazarus', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India.'}, {'ForeName': 'Rakshanda', 'Initials': 'R', 'LastName': 'Liaqat', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Sharif', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Weobong', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Faculty of Epidemiology and Population Health, Department of Population Health, London School of Hygiene and Tropical Medicine, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Zaidi', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Shaffaq', 'Initials': 'S', 'LastName': 'Zuliqar', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath Centre, Socorro Village, Bardez-Goa, Goa, India; Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2019.11.110']
360,32191142,Enrollment and transition challenges in the International Maternal Pediatric and Adolescent AIDS Clinical Trials (IMPAACT) network's PROMISE trial for resource-limited regions.,"BACKGROUND
We describe enrollment and accrual challenges in the ""Promoting Maternal and Infant Survival Everywhere"" (PROMISE) trial conducted in resource-limited countries, as well as the challenges in transitioning participants from the antepartum to the postpartum components of the study.
METHODS
PROMISE was a large multi-national randomized controlled trial of the safety and efficacy of interventions to reduce perinatal transmission of HIV-1 (HIV) during pregnancy and breastfeeding and of interventions to preserve maternal health after cessation of perinatal transmission risk. The PROMISE study included two protocols for HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment. The PROMISE breastfeeding protocol (1077BF) used a sequential randomization design with up to three randomizations (Antepartum, Postpartum, and Maternal Health). The PROMISE formula-feeding protocol (1077FF) had two randomizations (Antepartum and Maternal Health). Women presenting to the clinic during early or active labor or in the immediate postpartum period were registered as Late Presenters and screened to determine whether eligible to participate in the Postpartum randomization.
RESULTS
The study was conducted at 14 sites in seven countries and opened to enrollment in April 2011. A total of 3259 pregnant women intending to breastfeed and an additional 284 pregnant women intending to formula feed were randomized in the Antepartum component. A total of 204 Late Presenters were registered during labor or after delivery. Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected). The successful overall enrollment and final primary study analyses results were attributed to substantial preparation before the study opened, collaboration among all stakeholders, close study monitoring during implementation and the flexibility to change and streamline the protocol.
CONCLUSIONS
Experiences from the PROMISE study illustrate the challenges of enrolling in longer term studies in the setting of rapidly evolving prevention and treatment standards priorities. The lessons learned will help the community, site investigators, and study coordinators in the design and implementation of future clinical trials.",2020,Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected).,"['14 sites in seven countries and opened to enrollment in April 2011', 'Women presenting to the clinic during early or active labor or in the immediate postpartum period were registered as Late Presenters and screened to determine whether eligible to participate in the Postpartum randomization', 'HIV-infected pregnant women in resource-limited countries who intended to either breastfeed or formula-feed their infants and did not meet country criteria for antiretroviral treatment', '3259 pregnant women intending to breastfeed and an additional 284 pregnant women intending to formula feed']",[],['perinatal transmission of HIV-1 (HIV'],"[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0233081', 'cui_str': 'Normal labor (finding)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],"[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",3259.0,0.112228,Enrollment was high among breastfeeding women (representing 96% of the target of 3400 women) but was lower than expected among women intending to formula feed (28% of 1000 expected) and late-presenting women (8% of 2500 expected).,"[{'ForeName': 'Konstantia', 'Initials': 'K', 'LastName': 'Angelidou', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Flynn', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Coletti', 'Affiliation': 'IMPAACT Operations Center, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'IMPAACT Operations Center, FHI 360, Durham, NC, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'McIntyre', 'Affiliation': 'Anova Health Institute, Johannesburg, South Africa.'}, {'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520912428']
361,32222079,Social communication deficits following early-life deprivation and relation to psychopathology: a randomized clinical trial of foster care.,"BACKGROUND
Children reared in institutions experience profound deprivation that is linked to impairments in social communication (SC). However, little is known about the long-term consequences of institutional rearing on SC through adolescence, and how SC deficits relate to broad-spectrum psychopathology. It is also unclear whether early removal from deprivation and placement into socially enriched environments remediates these difficulties.
METHODS
Children reared in Romanian institutions from the Bucharest Early Intervention Project were randomly assigned to care as usual or foster care intervention in early childhood. An age- and sex-matched group of never-institutionalized children was also recruited. SC data from 208 children at age 8 and 129 children at 16 were collected using the Social Communication Questionnaire. Psychopathology was assessed as saved factor scores for general (P) and specific internalizing (INT) and externalizing (EXT) problems. We examined (a) whether institutional rearing is associated with continued SC deficits into adolescence; (b) whether early placement into foster care mitigates risk for SC problems; and (c) associations between SC and psychopathology from middle childhood (age 8) to adolescence (age 16).
RESULTS
Findings suggest that: (a) institutionally-reared children have significantly more SC problems than never-institutionalized children at age 16; (b) children placed into foster care early in life have fewer problems with reciprocal social interaction compared to those with prolonged institutional rearing; and (c) deficits in SC at age 8 partially account for the link between institutional rearing and general psychopathology at age 16.
CONCLUSIONS
Early deprivation is associated with impairments in SC that persist into adolescence, with evidence for the remedial benefit of family-based care in the domain of reciprocal social interaction. Moreover, deficits in SC among ever-institutionalized children in middle childhood may increase the risk of broad-spectrum psychopathology in adolescence, thus providing one putative target for early intervention to safeguard against later psychiatric problems.",2020,Psychopathology was assessed as saved factor scores for general (P) and specific internalizing (INT) and externalizing (EXT) problems.,"['208 children at age 8 and 129 children at 16 were collected using the Social Communication Questionnaire', 'An age- and sex-matched group of never-institutionalized children', 'Children reared in Romanian institutions from the Bucharest Early Intervention Project', 'middle childhood (age 8) to adolescence (age 16']",['care as usual or foster care intervention'],"['Social communication deficits', 'SC problems', 'saved factor scores for general (P) and specific internalizing (INT) and externalizing (EXT) problems', 'Psychopathology']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0008099', 'cui_str': 'Institutionalized Child'}, {'cui': 'C0008091', 'cui_str': 'Child Rearing'}, {'cui': 'C2919684', 'cui_str': 'Romanian'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",208.0,0.0681155,Psychopathology was assessed as saved factor scores for general (P) and specific internalizing (INT) and externalizing (EXT) problems.,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13222']
362,32222134,Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.,"BACKGROUND
The effect of vericiguat, a novel oral soluble guanylate cyclase stimulator, in patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received intravenous diuretic therapy is unclear.
METHODS
In this phase 3, randomized, double-blind, placebo-controlled trial, we assigned 5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy. The primary outcome was a composite of death from cardiovascular causes or first hospitalization for heart failure.
RESULTS
Over a median of 10.8 months, a primary-outcome event occurred in 897 of 2526 patients (35.5%) in the vericiguat group and in 972 of 2524 patients (38.5%) in the placebo group (hazard ratio, 0.90; 95% confidence interval [CI], 0.82 to 0.98; P = 0.02). A total of 691 patients (27.4%) in the vericiguat group and 747 patients (29.6%) in the placebo group were hospitalized for heart failure (hazard ratio, 0.90; 95% CI, 0.81 to 1.00). Death from cardiovascular causes occurred in 414 patients (16.4%) in the vericiguat group and in 441 patients (17.5%) in the placebo group (hazard ratio, 0.93; 95% CI, 0.81 to 1.06). The composite of death from any cause or hospitalization for heart failure occurred in 957 patients (37.9%) in the vericiguat group and in 1032 patients (40.9%) in the placebo group (hazard ratio, 0.90; 95% CI, 0.83 to 0.98; P = 0.02). Symptomatic hypotension occurred in 9.1% of the patients in the vericiguat group and in 7.9% of the patients in the placebo group (P = 0.12), and syncope occurred in 4.0% of the patients in the vericiguat group and in 3.5% of the patients in the placebo group (P = 0.30).
CONCLUSIONS
Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo. (Funded by Merck Sharp & Dohme [a subsidiary of Merck] and Bayer; VICTORIA ClinicalTrials.gov number, NCT02861534.).",2020,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","['patients with high-risk heart failure', 'patients with heart failure and reduced ejection fraction who had recently been hospitalized or had received', 'Patients with Heart Failure and Reduced Ejection Fraction', '5050 patients with chronic heart failure (New York Heart Association class II, III, or IV) and an ejection fraction of less than 45% to receive']","['vericiguat (target dose, 10 mg once daily) or placebo, in addition to guideline-based medical therapy', 'placebo', 'intravenous diuretic therapy']","['syncope', 'Death from cardiovascular causes', 'Symptomatic hypotension', 'composite of death from cardiovascular causes or first hospitalization for heart failure', 'death from cardiovascular causes or hospitalization for heart failure', 'hospitalized for heart failure', 'composite of death from any cause or hospitalization for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4078709', 'cui_str': 'vericiguat'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0948575', 'cui_str': 'Diuretic therapy'}]","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",5050.0,0.580875,"Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received vericiguat than among those who received placebo.","[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Burkert', 'Initials': 'B', 'LastName': 'Pieske', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ezekowitz', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Carolyn S P', 'Initials': 'CSP', 'LastName': 'Lam', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Mahesh J', 'Initials': 'MJ', 'LastName': 'Patel', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Roessig', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Koglin', 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'From the Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., J.E.); Charité University Medicine and German Heart Center, Berlin (B.P.), and Bayer, Wuppertal (L.R.) - all in Germany; Duke Clinical Research Institute, Duke University, Durham, NC (K.J.A., A.F.H., S.E.M., C.M.O.); University of Mississippi Medical Center, Jackson (J.B.); National Heart Center Singapore and Duke-National University of Singapore, Singapore (C.S.P.L.); the Cardiology Department, Wroclaw Medical University, Wroclaw, Poland (P.P.); University of Groningen, Groningen, the Netherlands (A.A.V.); Merck, Kenilworth, NJ (G.J., M.J.P., J.K.); and Inova Heart and Vascular Institute, Falls Church, VA (C.M.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915928']
363,32222135,Rivaroxaban in Peripheral Artery Disease after Revascularization.,"BACKGROUND
Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events. The efficacy and safety of rivaroxaban in this context are uncertain.
METHODS
In a double-blind trial, patients with peripheral artery disease who had undergone revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) plus aspirin or placebo plus aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH) was a secondary safety outcome.
RESULTS
A total of 6564 patients underwent randomization; 3286 were assigned to the rivaroxaban group, and 3278 were assigned to the placebo group. The primary efficacy outcome occurred in 508 patients in the rivaroxaban group and in 584 in the placebo group; the Kaplan-Meier estimates of the incidence at 3 years were 17.3% and 19.9%, respectively (hazard ratio, 0.85, 95% confidence interval [CI], 0.76 to 0.96; P = 0.009). TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07). ISTH major bleeding occurred in 140 patients in the rivaroxaban group, as compared with 100 patients in the placebo group (5.94% and 4.06%; hazard ratio, 1.42; 95% CI, 1.10 to 1.84; P = 0.007).
CONCLUSIONS
In patients with peripheral artery disease who had undergone lower-extremity revascularization, rivaroxaban at a dose of 2.5 mg twice daily plus aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes than aspirin alone. The incidence of TIMI major bleeding did not differ significantly between the groups. The incidence of ISTH major bleeding was significantly higher with rivaroxaban and aspirin than with aspirin alone. (Funded by Bayer and Janssen Pharmaceuticals; VOYAGER PAD ClinicalTrials.gov number, NCT02504216.).",2020,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","['patients with peripheral artery disease who had undergone lower-extremity revascularization', 'patients with peripheral artery disease who had undergone revascularization', '508 patients in the', 'Peripheral Artery Disease after Revascularization', 'Patients with peripheral artery disease who have undergone lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events', '6564 patients underwent randomization; 3286 were assigned to the']","['aspirin', 'placebo', 'Rivaroxaban', 'aspirin or placebo plus aspirin', 'rivaroxaban']","['composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'efficacy and safety', 'TIMI major bleeding', 'incidence of TIMI major bleeding', 'ISTH major bleeding', 'incidence of ISTH major bleeding', 'acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes', 'Kaplan-Meier estimates of the incidence', 'major bleeding, defined according to the Thrombolysis in Myocardial Infarction (TIMI) classification; major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1720943', 'cui_str': 'Product-Limit Method'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",6564.0,0.574825,"TIMI major bleeding occurred in 62 patients in the rivaroxaban group and in 44 patients in the placebo group (2.65% and 1.87%; hazard ratio, 1.43; 95% CI, 0.97 to 2.10; P = 0.07).","[{'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rupert M', 'Initials': 'RM', 'LastName': 'Bauersachs', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Sonia S', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'E Sebastian', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Fanelli', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Warren H', 'Initials': 'WH', 'LastName': 'Capell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Diao', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Jaeger', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Connie N', 'Initials': 'CN', 'LastName': 'Hess', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Akos F', 'Initials': 'AF', 'LastName': 'Pap', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kittelson', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Gudz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Mátyás', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Dainis K', 'Initials': 'DK', 'LastName': 'Krievins', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brodmann', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muehlhofer', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Lloyd P', 'Initials': 'LP', 'LastName': 'Haskell', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'From Colorado Prevention Center (CPC) Clinical Research (M.P.B., M.R.N., W.H.C., L.D., N.J., C.N.H., W.R.H.), the Department of Medicine, Division of Cardiovascular Medicine (M.P.B., C.N.H., W.R.H.), the Department of Surgery, Division of Vascular Surgery (M.R.N.), and the Department of Medicine, Division of Endocrinology (W.H.C.), University of Colorado Anschutz Medical Campus, and the Department of Biostatistics and Informatics, Colorado School of Public Health (J.M.K.) - all in Aurora; the Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt, and Center for Thrombosis and Hemostasis, University of Mainz, Mainz (R.M.B.), the Department of Vascular Medicine, Vascular Surgery-Angiology-Endovascular Therapy, University of Hamburg-Eppendorf, Hamburg (E.S.D.), and Bayer, Wuppertal (A.F.P., E.M.) - all in Germany; the Population Health Research Institute, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada (S.S.A.); Duke Clinical Research Institute, Division of Cardiology, Duke University, Durham, NC (M.R.P.); the Vascular and Interventional Radiology Department, Careggi University Hospital, University of Florence, Florence, Italy (F.F.); Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine (I.G.); B-A-Z County University Teaching Hospital, Miskolc, Hungary (L.M.); University of Latvia, Pauls Stradins University Hospital, Riga (D.K.K.); ECLA (Estudios Clínicos Latino América), ICR (Instituto Cardiovascular de Rosario), Rosario, Argentina (R.D.); the Division of Angiology, Medical University Graz, Graz, Austria (M.B.); and Janssen Research and Development, Raritan (L.P.H.), and Thrombosis Group Head, Clinical Development, Bayer U.S., Whippany (S.D.B.) - both in New Jersey.'}]",The New England journal of medicine,['10.1056/NEJMoa2000052']
364,31860742,Relationship between herpesviruses and periodontal disease progression.,"AIM
To investigate the role of Epstein-Barr virus (EBV), cytomegalovirus (CMV), and anaerobic bacteria in the progression of periodontitis.
METHODS
Eighty-one adults with generalized moderate to severe periodontitis were randomly assigned to: oral hygiene or scaling and root planning ± placebo or polyunsaturated fatty acids fish oil. Subgingival plaque samples collected from three healthy and three disease sites at weeks 0, 16, and 28 and from sites demonstrating disease progression were analysed for EBV, CMV, P. gingivalis (Pg), T. forsythia (Tf), and T. denticola (Td) DNA using quantitative polymerase chain reaction.
RESULTS
Cytomegalovirus was detected in 0.3% (4/1454) sites. EBV was present in 12.2% of healthy sites (89/728) and 27.6% disease sites (201/726; p < .0001), but was in low copy number. Disease progression occurred in 28.4% of participants (23/81) and developed predominantly at sites identified as diseased (75/78; 96.2%). CMV and EBV were not associated with disease progression (p = .13) regardless of treatment. In contrast, disease sites were associated with higher levels of Pg, Td, Tf, and total bacteria, and sites that exhibited disease progression were associated with an abundance of Td and Tf (p < .04).
CONCLUSION
Disease progression was associated with Gram-negative anaerobic bacteria; not EBV or CMV.",2020,Disease progression occurred in 28.4% of participants (23/81) and developed predominantly at sites identified as diseased (75/78; 96.2%).,['Eighty-one adults with generalized moderate to severe periodontitis'],"['Epstein-Barr virus (EBV), cytomegalovirus (CMV) and anaerobic bacteria', 'oral hygiene or scaling and root planing\xa0±\xa0placebo or polyunsaturated fatty acids fish oil']","['EBV', 'levels of Pg, Td, Tf and total bacteria, and sites that exhibited disease progression', 'disease progression', 'EBV, CMV, P. gingivalis (Pg), T. forsythia (Tf), and T. denticola (Td) DNA using quantitative polymerase chain reaction', 'CMV and EBV', 'Disease progression']","[{'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0004613', 'cui_str': 'Bacteria, Anaerobic'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1018538', 'cui_str': 'Goldenbells'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}]",81.0,0.0231126,Disease progression occurred in 28.4% of participants (23/81) and developed predominantly at sites identified as diseased (75/78; 96.2%).,"[{'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Emecen-Huja', 'Affiliation': 'Department of Oral Health Practice, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Danaher', 'Affiliation': 'Department of Oral Health Practice, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Dolphus R', 'Initials': 'DR', 'LastName': 'Dawson', 'Affiliation': 'Department of Oral Health Practice, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Center for Oral Health Research, College of Dentistry, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Kryscio', 'Affiliation': 'Department of Statistics, College of Arts & Sciences, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Ebersole', 'Affiliation': 'Center for Oral Health Research, College of Dentistry, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Miller', 'Affiliation': 'Department of Oral Health Practice, University of Kentucky, Lexington, Kentucky.'}]",Journal of clinical periodontology,['10.1111/jcpe.13239']
365,32074076,Long term response of electrochemotherapy with reduced dose of bleomycin in elderly patients with head and neck non-melanoma skin cancer.,"Background Electrochemotherapy (ECT) is a local cancer treatment based on electroporation where the electric field is used to enhance cell membrane permeability and thereby facilitating the transition of chemotherapeutic agents into the cell. For the treatment of non-melanoma skin cancer, a standard dosage of 15,000 IU/m2 bleomycin (BLM) is used. The aim of the present study was to evaluate the long-term ECT response in the group of elderly patients with non-melanoma skin cancer treated with a reduced dose of BLM in comparison to the outcome in the patients treated with the standard dose of BLM. Patients and methods Twenty-eight patients older than 65 years, with a total of 52 non-melanoma skin lesions were included in the study. Twelve patients (24 lesions) in the experimental group received a reduced dose of BLM (10,000 IU/m2), 16 patients (28 lesions) were treated with a standard dose of BLM (15,000 IU/m2). Results No statistically significant difference in tumor control was observed between both groups. In the experimental group, tumors recurred in 39.0% of treated lesions in a median follow-up time of 28 months. In the control group, the recurrence rate of treated lesions was 15.4% in a median follow-up time of 40 months. Conclusions ECT with a reduced dose of BLM is a feasible treatment option for elderly patients with equal efficacy to standard dose treatment and should be considered as a treatment modality in advanced aged patients with comorbidities, where overall life expectancy is poor.",2020,"In the experimental group, tumors recurred in 39.0% of treated lesions in a median follow-up time of 28 months.","['Twelve patients (24 lesions', 'elderly patients', 'elderly patients with non-melanoma skin cancer', 'elderly patients with head and neck non-melanoma skin cancer', 'Patients and methods Twenty-eight patients older than 65 years, with a total of 52 non-melanoma skin lesions were included in the study', 'advanced aged patients with comorbidities']","[' Electrochemotherapy (ECT', 'bleomycin (BLM', 'bleomycin', 'electrochemotherapy', 'BLM']","['tumor control', 'recurrence rate of treated lesions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0151779', 'cui_str': 'Familial Atypical Mole-Malignant Melanoma Syndrome'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0678054', 'cui_str': 'Electroporation Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",28.0,0.0432225,"In the experimental group, tumors recurred in 39.0% of treated lesions in a median follow-up time of 28 months.","[{'ForeName': 'Crt', 'Initials': 'C', 'LastName': 'Jamsek', 'Affiliation': 'Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Sersa', 'Affiliation': 'Department of Experimental Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Masa', 'Initials': 'M', 'LastName': 'Bosnjak', 'Affiliation': 'Department of Experimental Oncology, Institute of Oncology Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Ales', 'Initials': 'A', 'LastName': 'Groselj', 'Affiliation': 'Department of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}]",Radiology and oncology,['10.2478/raon-2020-0009']
366,31757262,Randomized placebo-controlled trial of galantamine in individuals with cocaine use disorder.,"No pharmacotherapies are approved for the treatment of cocaine use disorder (CUD). Galantamine, a cholinesterase inhibitor, has shown initial promise for cocaine use reduction in methadone-maintained individuals with CUD and cognitive improvement in abstinent individuals with past CUD. However, galantamine has not previously tested in individuals with current CUD and no comorbid opioid use disorder or methadone maintenance. The goal of this 13-week, double-blind, placebo-controlled, randomized controlled trial was to test the efficacy of galantamine (8 mg or 16 mg/day; extended release (ER)) for reducing cocaine use and improving cognitive function in individuals with cocaine use disorder (CUD). Ninety-three treatment-seeking cocaine users were randomized to placebo (n = 32), 8 mg/day galantamine (n = 31) or 16 mg/day galantamine (n = 30). The medication was well-tolerated with minimal reports of side-effects. However, there were no significant treatment group differences in cocaine use outcomes (as measured by self-report or urines). The 16 mg galantamine group had a greater improvement in working memory capacity (Backwards Digit Span), but there were no other significant treatment group differences on key cognitive outcomes. These findings did not provide support for the efficacy of galantamine as a treatment for cocaine use in this sample of individuals with CUD.",2019,"The 16 mg galantamine group had a greater improvement in working memory capacity (Backwards Digit Span), but there were no other significant treatment group differences on key cognitive outcomes.","['Ninety-three treatment-seeking cocaine users', 'individuals with cocaine use disorder (CUD', 'abstinent individuals with past CUD', 'individuals with current CUD and no comorbid opioid use disorder or methadone maintenance', 'individuals with CUD', 'individuals with cocaine use disorder']","['placebo', 'Galantamine', 'galantamine', 'galantamine (n\u202f=\u202f31) or 16\u202fmg/day galantamine']","['key cognitive outcomes', 'working memory capacity (Backwards Digit Span']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0239076', 'cui_str': 'Cocaine user (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0582802', 'cui_str': 'Digit'}]",93.0,0.0432834,"The 16 mg galantamine group had a greater improvement in working memory capacity (Backwards Digit Span), but there were no other significant treatment group differences on key cognitive outcomes.","[{'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'DeVito', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Babuscio', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'Yale University, School of Medicine, Department of Psychiatry, New Haven, CT, United States of America; VA Connecticut Healthcare System, West Haven, CT, United States of America. Electronic address: Mehmet.Sofuoglu@yale.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.009']
367,32179870,Dairy product intake decreases bone resorption following a 12-week diet and exercise intervention in overweight and obese adolescent girls.,"BACKGROUND
We examined whether increased dairy intake was associated with changes in the levels of bone-related biochemical markers in overweight/obese adolescent girls undergoing a 12-week diet and exercise intervention.
METHODS
Thirty-five girls were assigned to a low dairy group (LDa; 0-2 servings/day; n = 16) or a higher dairy group (RDa; 4 servings/day; n = 19). Morning, fasted/resting blood samples were collected before and after the intervention and serum concentrations of procollagen-type-1-N-terminal-propeptide (P1NP), β-isomerized-C-terminal-cross-linking-telopeptides (β-CTX), osteocalcin (OC), 25-hydroxyvitamin-D, sclerostin and parathyroid hormone were measured.
RESULTS
At baseline, there were no significant differences between groups in any bone variable. Changes (∆) over time in β-CTΧ (p = 0.035; interaction) and OC (p = 0.015; interaction) were significantly different between groups characterized by decreases in RDa and increases in LDa. P1NP and P1NP:β-CTX ratio decreased in both groups (main time effects: p = 0.003, p = 0.041, respectively). ∆β-CTX (r = -0.37; p = 0.028) and ∆OC (r = -0.39; p = 0.021) were correlated with average number of dairy servings consumed during the study and with each other (r = 0.45; p = 0.006). ∆OC was not correlated with ∆P1NP (r = 0.19; p = 0.27).
CONCLUSIONS
Our results suggest that the osteogenic response to a diet and exercise program in this population can be improved with increased dairy intake via a decrease in bone resorption.
IMPACT
We demonstrated that bone resorption significantly decreased over the intervention period in the group consuming adequate levels of dairy products compared to the group consuming little to no dairy products. Change in bone resorption was negatively correlated with average number of dairy servings consumed during the study. Our results suggest that the osteogenic response to a diet and exercise program in this population can be improved with increased dairy intake via a decrease in bone resorption. This is the first study to date to assess changes in bone marker status following a lifestyle intervention with exercise and different intakes of dairy products in a sample of OW/OB adolescent girls. We provide evidence that increased dairy product intake is associated with beneficial changes in circulating levels of bone-related biochemical markers in these girls undergoing a 12-week lifestyle (nutrition counseling and exercise training) intervention program. The main impact of our work relates particularly to the recent changes to Canada's food guide. Using the old recommendations, we demonstrated that the inclusion of 3-4 servings of mixed dairy foods per day improved bone health (primarily as a decrease in resorption) in OW/OB adolescent girls and that this level of dairy product intake appears appropriate and should still be encouraged for this age group. We also demonstrated that adolescent girls, a group that usually does not sufficiently consume dairy products, also improved their BMI percentile and nutrient intake with the inclusion of dairy products in their diets.",2020,"P1NP and P1NP:β-CTX ratio decreased in both groups (main time effects: p = 0.003, p = 0.041, respectively).","['Thirty-five girls', 'overweight/obese adolescent girls undergoing a 12-week', 'sample of OW/OB adolescent girls', 'adolescent girls', 'overweight and obese adolescent girls']","['lifestyle intervention with exercise and different intakes of dairy products', '∆β-CTX', 'Dairy product intake', 'exercise intervention', 'diet and exercise intervention', 'β-CTΧ', 'low dairy group (LDa; 0-2 servings/day; n\u2009=\u200916) or a higher dairy group (RDa']","['∆OC', 'bone resorption', 'BMI percentile and nutrient intake', 'P1NP and P1NP:β-CTX ratio', 'RDa and increases in LDa', 'serum concentrations of procollagen-type-1-N-terminal-propeptide (P1NP), β-isomerized-C-terminal-cross-linking-telopeptides (β-CTX), osteocalcin (OC), 25-hydroxyvitamin-D, sclerostin and parathyroid hormone', 'average number of dairy servings', 'dairy intake', 'bone health']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010947', 'cui_str': 'Dairy Products'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",35.0,0.0327089,"P1NP and P1NP:β-CTX ratio decreased in both groups (main time effects: p = 0.003, p = 0.041, respectively).","[{'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'School of Kinesiology and Health Science, Faculty of Health, York University, 4700 Keele Street, Toronto, ON, Canada. ajosse@yorku.ca.'}, {'ForeName': 'Izabella A', 'Initials': 'IA', 'LastName': 'Ludwa', 'Affiliation': 'Centre for Bone and Muscle Health, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, Canada.'}, {'ForeName': 'Rozalia', 'Initials': 'R', 'LastName': 'Kouvelioti', 'Affiliation': 'Centre for Bone and Muscle Health, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Calleja', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, Canada.'}, {'ForeName': 'Bareket', 'Initials': 'B', 'LastName': 'Falk', 'Affiliation': 'Centre for Bone and Muscle Health, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, Canada.'}, {'ForeName': 'Wendy E', 'Initials': 'WE', 'LastName': 'Ward', 'Affiliation': 'Centre for Bone and Muscle Health, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, Canada.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Klentrou', 'Affiliation': 'Centre for Bone and Muscle Health, Faculty of Applied Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St. Catharines, ON, Canada.'}]",Pediatric research,['10.1038/s41390-020-0834-5']
368,32217842,"Efficacy and Safety of Two Resilient Hyaluronic Acid Fillers in the Treatment of Moderate-to-Severe Nasolabial Folds: A 64-Week, Prospective, Multicenter, Controlled, Randomized, Double-Blinded, and Within-Subject Study.","BACKGROUND
A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures.
OBJECTIVE
The efficacy, durability, and safety of 2 of these resilient HA (RHA) fillers, and their noninferiority to an effective HA comparator available in the United States, were tested in the treatment of dynamic facial wrinkles.
METHODS
A 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial was carried out on 174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs). Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators. Self-perception was evaluated with FACE-Q and satisfaction scales.
RESULTS
The per-protocol populations included 67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups. Significant improvement of mean WSRS scores and associated responder rates established the noninferiority of RHA fillers to their comparator, over 15 months. Aesthetic improvement and subject satisfaction were durably high, with no meaningful differences between the fillers. Treatments were safe and well tolerated.
CONCLUSION
The 2 RHA fillers are at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin-phototypes.",2020,"Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators.","['Moderate-to-Severe Nasolabial Folds', '67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups', '174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs']","['Two Resilient Hyaluronic Acid Fillers', 'resilient HA (RHA) fillers']","['Efficacy and Safety', 'Self-perception', 'proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators', 'Aesthetic improvement and subject satisfaction', 'mean WSRS scores', 'safe and well tolerated', 'efficacy, durability, and safety']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial Fold'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0729441', 'cui_str': 'Filler (substance)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0037301', 'cui_str': 'Skin Wrinkling'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",174.0,0.109382,"Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators.","[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Monheit', 'Affiliation': 'Private Practice, Total Skin and Beauty Dermatology Center, Birmingham, Alabama.'}, {'ForeName': 'Joely', 'Initials': 'J', 'LastName': 'Kaufman-Janette', 'Affiliation': 'Private Practice, Skin Research Institute, Miami, Florida.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Joseph', 'Affiliation': 'Private Practice, Clinical Testing of Beverly Hills, Beverly Hills, California.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Shamban', 'Affiliation': 'Private Practice, AVA MD, Santa Monica, California.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Dover', 'Affiliation': 'Private Practice, Skin Care Physicians, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': 'Private Practice, California Dermatology & Clinical Research Institute, Encinitas, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002391']
369,31618129,Phase III Randomized Trial of Chemotherapy With or Without Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer.,"PURPOSE
We evaluated the addition of bevacizumab, a humanized monoclonal antibody that targets vascular endothelial growth factor, to platinum-based chemotherapy in recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
PATIENTS AND METHODS
Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier) recurrent or metastatic SCCHN were randomly assigned to receive a platinum-based chemotherapy doublet with or without bevacizumab 15 mg/kg given intravenously every 3 weeks until disease progression. Chemotherapy could be discontinued after six cycles if a maximum response was achieved.
RESULTS
The study randomly assigned 403 patients. Median overall survival (OS) was 12.6 months with bevacizumab plus chemotherapy (BC) and 11.0 months with chemotherapy alone (hazard ratio, 0.87; 95% CI, 0.70 to 1.09; P = .22). At 2, 3, and 4 years, the OS rates were 25.2% v 18.1%, 16.4% v 10.0%, and 11.8% v 6.4% for BC versus chemotherapy, respectively. In an analysis of 365 eligible patients who started treatment, the hazard ratio was 0.82 (95% CI, 0.65 to 1.04; P = .10), with a median OS of 14.2 months on BC v 11.1 months on chemotherapy. Median progression-free survival with BC was 6.0 months v 4.3 months with chemotherapy ( P = .0014). Overall response rates were 35.5% with BC and 24.5% with chemotherapy ( P = .016). There was increased toxicity, including a higher rate of treatment-related grade 3 to 5 bleeding events (6.7% v 0.5%; P < .001) and treatment-related deaths (9.3% v 3.5%; P = .022) with BC versus chemotherapy.
CONCLUSION
The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities. These results encourage biomarker-driven studies of angiogenesis inhibitors with better toxicity profiles in select patients with SCCHN.",2019,The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities.,"['403 patients', 'Patients With Recurrent or Metastatic Head and Neck Cancer', 'select patients with SCCHN', 'recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN', 'Patients with chemotherapy-naïve (or with prior platinum as part of multimodal therapy completed ≥ 4 months earlier', 'recurrent or metastatic SCCHN']","['platinum-based chemotherapy', 'platinum-based chemotherapy doublet with or without bevacizumab', 'bevacizumab plus chemotherapy (BC', 'bevacizumab', 'Chemotherapy With or Without Bevacizumab', 'Chemotherapy']","['treatment-related deaths', 'response rate and progression-free survival with increased toxicities', 'higher rate of treatment-related grade 3 to 5 bleeding events', 'toxicity', 'Overall response rates', 'Median overall survival (OS', 'OS rates', 'hazard ratio', 'Median progression-free survival with BC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",403.0,0.094703,The addition of bevacizumab to chemotherapy did not improve OS but improved the response rate and progression-free survival with increased toxicities.,"[{'ForeName': 'Athanassios', 'Initials': 'A', 'LastName': 'Argiris', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA.'}, {'ForeName': 'Shuli', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Dana Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Panayiotis', 'Initials': 'P', 'LastName': 'Savvides', 'Affiliation': 'University of Arizona Cancer Center, Phoenix, AZ.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Ohr', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gilbert', 'Affiliation': 'Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Marshall A', 'Initials': 'MA', 'LastName': 'Levine', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, MD.'}, {'ForeName': 'Arnab', 'Initials': 'A', 'LastName': 'Chakravarti', 'Affiliation': 'The Ohio State University Medical School, Columbus, OH.'}, {'ForeName': 'Missak', 'Initials': 'M', 'LastName': 'Haigentz', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Chukwuemeka V', 'Initials': 'CV', 'LastName': 'Ikpeazu', 'Affiliation': 'University of Miami, Miami, FL.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Schneider', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Harlan A', 'Initials': 'HA', 'LastName': 'Pinto', 'Affiliation': 'Stanford University Medical Center, Stanford, CA.'}, {'ForeName': 'Arlene A', 'Initials': 'AA', 'LastName': 'Forastiere', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00555']
370,32216138,Identifying Change Targets for Posttraumatic Stress Disorder Among Suicidal and Self-Injuring Women With Borderline Personality Disorder.,"Research on psychotherapies for posttraumatic stress disorder (PTSD) is increasingly focused on understanding not only which treatments work but why and for whom they work. The present pilot study evaluated the temporal relations between five hypothesized change targets-posttraumatic cognitions, guilt, shame, general emotion dysregulation, and experiential avoidance-and PTSD severity among women with PTSD, borderline personality disorder, and recent suicidal and/or self-injurious behaviors. Participants (N = 26) were randomized to receive 1 year of dialectical behavior therapy (DBT) with or without the DBT prolonged exposure (DBT PE) protocol for PTSD. Potential change targets and PTSD were assessed at 4-month intervals during treatment and at 3-month posttreatment follow-up. Time-lagged mixed-effects models indicated that between-person differences in all change targets except guilt were associated with more severe PTSD, η 2 s = .32-.55, and, except for general emotion dysregulation, slowed the rate of change in PTSD severity over time, η 2 s = .20-.39. In DBT but not in DBT + DBT PE, individuals with higher levels of guilt and experiential avoidance relative to their own average had more severe PTSD at the next assessment point, η 2 s = .12-.25. The associations between the proposed change targets and PTSD severity were not bidirectional, except for general emotion dysregulation, η 2 = .50; and posttraumatic cognitions, η 2 = .06. These preliminary findings suggest that trauma-related cognitions, shame, and guilt, as well as problems regulating them, may be important change targets for improving PTSD in this patient population.",2020,"The associations between the proposed change targets and PTSD severity were not bidirectional, except for general emotion dysregulation, η 2 = .50; and posttraumatic cognitions, η 2 = .06.","['women with PTSD, borderline personality disorder, and recent suicidal and/or self-injurious behaviors', 'Posttraumatic Stress Disorder Among Suicidal and Self-Injuring Women With Borderline Personality Disorder', 'Participants (N = 26', 'posttraumatic stress disorder (PTSD']",['dialectical behavior therapy (DBT) with or without the DBT prolonged exposure (DBT PE) protocol for PTSD'],"['severe PTSD', 'posttraumatic cognitions, guilt, shame, general emotion dysregulation, and experiential avoidance-and PTSD severity', 'general emotion dysregulation', 'posttraumatic cognitions', 'rate of change in PTSD severity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",26.0,0.024507,"The associations between the proposed change targets and PTSD severity were not bidirectional, except for general emotion dysregulation, η 2 = .50; and posttraumatic cognitions, η 2 = .06.","[{'ForeName': 'Melanie S', 'Initials': 'MS', 'LastName': 'Harned', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Schmidt', 'Affiliation': 'VA Puget Sound Health Care System, Seattle, Washington, USA.'}]",Journal of traumatic stress,['10.1002/jts.22504']
371,31701861,Effectiveness of a Behavior Change Intervention with Hand Sanitizer Use and Respiratory Hygiene in Reducing Laboratory-Confirmed Influenza among Schoolchildren in Bangladesh: A Cluster Randomized Controlled Trial.,"Schoolchildren are commonly linked to influenza transmission. Handwashing with soap has been shown to decrease infections; however, improving handwashing practices using soap and water is difficult in low-resource settings. In these settings, alternative hygiene options, such as hand sanitizer, could improve handwashing promotion to reduce influenza virus infections. We conducted a cluster randomized control trial in 24 primary schools in Dhaka to assess the effectiveness of hand sanitizer and a respiratory hygiene education intervention in reducing influenza-like illness (ILI) and laboratory-confirmed influenza during June-September 2015. Twelve schools were randomly selected to receive hand sanitizer and respiratory hygiene education, and 12 schools received no intervention. Field staff actively followed children daily to monitor for new ILI episodes (cough with fever) through school visits and by phone if a child was absent. When an illness episode was identified, medical technologists collected nasal swabs to test for influenza viruses. During the 10-week follow-up period, the incidence of ILI per 1,000 student-weeks was 22 in the intervention group versus 27 in the control group ( P -value = 0.4). The incidence of laboratory-confirmed influenza was 53% lower in the intervention schools (3/1,000 person-weeks) than in the control schools (6/1,000 person-weeks) ( P -value = 0.01). Hand sanitizer and respiratory hygiene education can help to reduce the risk of influenza virus transmission in schools.",2019,"The incidence of laboratory-confirmed influenza was 53% lower in the intervention schools (3/1,000 person-weeks) than in the control schools (6/1,000 person-weeks)","['Schoolchildren in Bangladesh', 'schools', 'Twelve schools', '24 primary schools in Dhaka to assess the effectiveness of hand sanitizer and a respiratory hygiene education intervention in reducing influenza-like illness (ILI) and laboratory-confirmed influenza during June-September 2015']","['hand sanitizer and respiratory hygiene education, and 12 schools received no intervention', 'Behavior Change Intervention with Hand Sanitizer Use and Respiratory Hygiene']",[],"[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1330330', 'cui_str': 'Hand Disinfectants'}, {'cui': 'C0204945', 'cui_str': 'Hygiene education (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0521839', 'cui_str': 'Influenza-like illness (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]","[{'cui': 'C1330330', 'cui_str': 'Hand Disinfectants'}, {'cui': 'C0204945', 'cui_str': 'Hygiene education (procedure)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]",[],,0.0346467,"The incidence of laboratory-confirmed influenza was 53% lower in the intervention schools (3/1,000 person-weeks) than in the control schools (6/1,000 person-weeks)","[{'ForeName': 'Debashish', 'Initials': 'D', 'LastName': 'Biswas', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Makhdum', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Sanofi US Services Inc., Cambridge, Massachusetts.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Roguski', 'Affiliation': 'The Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'Probir K', 'Initials': 'PK', 'LastName': 'Ghosh', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Shahana', 'Initials': 'S', 'LastName': 'Parveen', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fosiul A', 'Initials': 'FA', 'LastName': 'Nizame', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mohammed Ziaur', 'Initials': 'MZ', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Fahmida', 'Initials': 'F', 'LastName': 'Chowdhury', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahmudur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'Institute of Epidemiology, Disease Control and Research (IEDCR), Dhaka, Bangladesh.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Sturm-Ramirez', 'Affiliation': 'The Centers for Disease Control and Prevention, Atlanta, Georgia.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'The Centers for Disease Control and Prevention, Atlanta, Georgia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0376']
372,32126576,Endoscopic ultrasonography-guided deployment of embolization coils and cyanoacrylate injection in gastric varices versus coiling alone: a randomized trial.,"BACKGROUND
Gastric variceal bleeding is a life-threating condition with challenging management. We aimed to compare the efficacy and safety of endoscopic ultrasonography (EUS)-guided coil embolization and cyanoacrylate injection versus EUS-guided coil embolization alone in the management of gastric varices.
METHODS
A single-center, parallel-randomized controlled trial involving 60 participants with gastric varices (GOV II and IGV I) who were randomly allocated to EUS-guided coil embolization and cyanoacrylate injection (n = 30) or EUS-guided coil embolization alone (n = 30). The primary end points were the technical and clinical success rates of both procedures. The secondary end points were the reappearance of gastric varices during follow-up, along with rebleeding, the need for reintervention, and complication and survival rates.
RESULTS
The technical success rate was 100 % in both groups. Immediate disappearance of varices was observed in 86.7 % of patients treated with coils and cyanoacrylate, versus 13.3 % of patients treated with coils alone ( P < 0.001). Median survival time was 16.4 months with coils and cyanoacrylate versus 14.2 months with coils alone ( P = 0.90). Rebleeding occurred in 3.3 % of patients treated with combined treatment and 20 % of those treated with coils alone ( P = 0.04). With combined treatment, 83.3 % of patients were free from reintervention versus 60 % with coils alone (hazard ratio 0.27; 95 % confidence interval 0.095 - 0.797; P = 0.01).
CONCLUSIONS
EUS-guided coil embolization with cyanoacrylate injection achieved excellent clinical success, with lower rates of rebleeding and reintervention than coil treatment alone. Multicenter studies are required to define the most appropriate technique for gastric variceal obliteration.",2020,"Immediate disappearance of varices was observed in 86.7 % of patients treated with coils and cyanoacrylate, versus 13.3 % of patients treated with coils alone ( P < 0.001).",['60 participants with gastric varices (GOV II and IGV I'],"['coils alone', 'cyanoacrylate', 'Endoscopic ultrasonography-guided deployment of embolization coils and cyanoacrylate injection', 'coiling alone', 'endoscopic ultrasonography (EUS)-guided coil embolization and cyanoacrylate injection versus EUS-guided coil embolization alone', 'EUS-guided coil embolization and cyanoacrylate injection (n\u200a=\u200a30) or EUS-guided coil embolization alone']","['Median survival time', 'efficacy and safety', 'Rebleeding', 'technical and clinical success rates of both procedures', 'technical success rate', 'reappearance of gastric varices', 'Immediate disappearance of varices', 'rebleeding and reintervention', 'excellent clinical success', 'rebleeding, the need for reintervention, and complication and survival rates']","[{'cui': 'C0017145', 'cui_str': 'Gastric Varix'}]","[{'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0010507', 'cui_str': 'Cyanoacrylates'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0522644', 'cui_str': 'Embolization coil, device (physical object)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0017145', 'cui_str': 'Gastric Varix'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0042345', 'cui_str': 'Varices'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",60.0,0.0756777,"Immediate disappearance of varices was observed in 86.7 % of patients treated with coils and cyanoacrylate, versus 13.3 % of patients treated with coils alone ( P < 0.001).","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Robles-Medranda', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Oleas', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Valero', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Puga-Tejada', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Baquerizo-Burgos', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Jesenia', 'Initials': 'J', 'LastName': 'Ospina', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pitanga-Lukashok', 'Affiliation': 'Instituto Ecuatoriano de Enfermedades Digestivas (IECED), Guayaquil, Ecuador.'}]",Endoscopy,['10.1055/a-1123-9054']
373,32209645,Continuous Glucose Monitoring in Pregnancy: Importance of Analyzing Temporal Profiles to Understand Clinical Outcomes.,"OBJECTIVE
To determine if temporal glucose profiles differed between 1 ) women who were randomized to real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG), 2 ) women who used insulin pumps or multiple daily insulin injections (MDIs), and 3 ) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT).
RESEARCH DESIGN AND METHODS
Standard summary metrics and functional data analysis (FDA) were applied to CGM data from the CONCEPTT trial (RT-CGM, n = 100; SMBG, n = 100) taken at baseline and at 24- and 34-weeks' gestation. Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
RESULTS
FDA revealed that women using RT-CGM had significantly lower glucose (0.4-0.8 mmol/L [7-14 mg/dL]) for 7 h/day (0800 h to 1200 h and 1600 h to 1900 h) compared with those with SMBG. Women using pumps had significantly higher glucose (0.4-0.9 mmol/L [7-16 mg/dL]) for 12 h/day (0300 h to 0600 h, 1300 h to 1800 h, and 2030 h to 0030 h) at 24 weeks with no difference at 34 weeks compared with MDI. Women who had an LGA infant ran a significantly higher glucose by 0.4-0.7 mmol/L (7-13 mg/dL) for 4.5 h/day at baseline, by 0.4-0.9 mmol/L (7-16 mg/dL) for 16 h/day at 24 weeks, and by 0.4-0.7 mmol/L (7-13 mg/dL) for 14 h/day at 34 weeks.
CONCLUSIONS
FDA of temporal glucose profiles gives important information about differences in glucose control and its timing, which are undetectable by standard summary metrics. Women using RT-CGM were able to achieve better daytime glucose control, reducing fetal exposure to maternal glucose.",2020,"Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
","['temporal glucose profiles differed between 1 ) women who were randomized to', 'Women who had an LGA infant ran a significantly', 'MDIs), and 3 ) women whose infants were born large for gestational age (LGA) or not, by assessing CGM data obtained from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT', 'Pregnancy']","['real-time continuous glucose monitoring (RT-CGM) or self-monitored blood glucose (SMBG), 2 ) women who used insulin pumps or multiple daily insulin injections']","['higher glucose', 'daytime glucose control, reducing fetal exposure to maternal glucose', '24-h glucose profiles']","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1848395', 'cui_str': 'Large for gestational age'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",2.0,0.024243,"Multivariable regression analysis determined if temporal differences in 24-h glucose profiles occurred between comparators in each of the three groups.
","[{'ForeName': 'Eleanor M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': 'Department of Clinical and Population Science, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, U.K. e.m.scott@leeds.ac.uk.'}, {'ForeName': 'Denice S', 'Initials': 'DS', 'LastName': 'Feig', 'Affiliation': 'Department of Medicine, Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Helen R', 'Initials': 'HR', 'LastName': 'Murphy', 'Affiliation': ""Division of Maternal Health, St Thomas' Hospital, King's College London, London, U.K.""}, {'ForeName': 'Graham R', 'Initials': 'GR', 'LastName': 'Law', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2527']
374,31671172,Improvement in adherence to antibiotic duration of therapy recommendations for uncomplicated cystitis: a quasi-experimental study.,"BACKGROUND
Acute uncomplicated cystitis is one of the most common diagnoses for which antibiotic treatment is prescribed in the outpatient setting. Despite the availability of national guidelines, there remains a wide pattern in prescriber choices for therapy. Recent data portray a picture of consistently longer durations than recommended prescribed in outpatient settings.
OBJECTIVE
The objective was to evaluate the effect of a system-based intervention on adherence to guideline-recommended durations of therapy for uncomplicated cystitis in the outpatient setting.
METHODS
This quasi-experimental study included women aged 18-64 years who were seen at five family medicine clinics at an academic medical centre and were prescribed targeted antibiotics for uncomplicated cystitis (nitrofurantoin monohydrate/macrocrystals 100 mg, trimethoprim-sulfamethoxazole 160/800 mg or ciprofloxacin 250 mg). The intervention involved revising or adding pre-filled, but modifiable, default prescribing instructions in the electronic health record (EHR) for the targeted antibiotics. We evaluated adherence to guideline-recommended duration of therapy as well as days of therapy (DOT) before and after the intervention.
RESULTS
A total of 787 pre-intervention and 862 post-intervention cases were included. Adherence to recommended duration of therapy increased from 29.4% to 76.3% (P < 0.01). The average DOT decreased by 23% from 6.6 to 5.1 (P < 0.01).
CONCLUSION
A stewardship intervention consisting of revising/adding default prescribing instructions to targeted antimicrobials in an EHR was associated with increased adherence to recommended durations of therapy for uncomplicated cystitis and reduction of unnecessary antibiotic exposure. More studies are needed to confirm effectiveness across multiple medical record platforms.",2020,Adherence to recommended duration of therapy increased from 29.4% to 76.3% (P < 0.01).,"['women aged 18-64 years who were seen at five family medicine clinics at an academic medical centre and were prescribed targeted antibiotics for uncomplicated cystitis ', 'A total of 787 pre-intervention and 862 post-intervention cases were included', 'uncomplicated cystitis in the outpatient setting', 'uncomplicated cystitis']","['system-based intervention', 'nitrofurantoin monohydrate/macrocrystals 100 mg, trimethoprim-sulfamethoxazole', 'ciprofloxacin']","['average DOT', 'Adherence to recommended duration of therapy']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3833703', 'cui_str': 'Family medicine clinic (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0724647', 'cui_str': 'Nitrofurantoin, Monohydrate'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0041044', 'cui_str': 'Sulfamethoxazole / Trimethoprim'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}]",787.0,0.032959,Adherence to recommended duration of therapy increased from 29.4% to 76.3% (P < 0.01).,"[{'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Giancola', 'Affiliation': 'Department of Pharmacy, Fort Sam Houston, TX, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Higginbotham', 'Affiliation': 'Department of Pharmacy, Fort Sam Houston, TX, USA.'}, {'ForeName': 'Deena E', 'Initials': 'DE', 'LastName': 'Sutter', 'Affiliation': 'Department of Pediatrics, Fort Sam Houston, TX, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Spencer', 'Affiliation': 'Department of Pediatrics, Fort Sam Houston, TX, USA.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Aden', 'Affiliation': 'Department of Graduate Medical Education, Fort Sam Houston, TX, USA.'}, {'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Barsoumian', 'Affiliation': 'Infectious Disease Service, Department of Medicine, Brooke Army Medical Center, Fort Sam Houston, TX, USA.'}]",Family practice,['10.1093/fampra/cmz068']
375,31715628,Self-efficacy and doctor support as mediators of depression outcomes following counselling by family doctors for intimate partner violence.,"BACKGROUND
Previous research shows counselling delivered by trained family doctors reduces depression for women experiencing intimate partner violence (IPV). However, the potential for self-efficacy, doctor support and safety enquiry to mediate these effects has not been examined.
OBJECTIVES
To assess whether (i) women experiencing IPV and counselled by a trained family doctor report greater self-efficacy, perceived doctor support and enquiry about safety than those receiving usual care and (ii) whether self-efficacy, doctor support and enquiry mediate effects of counselling on depression for these women.
METHODS
Quantitative analysis as part of a process evaluation of data from a cluster randomized controlled trial of 272 female IPV survivors attending 52 Australian primary care clinics. Intervention group doctors were trained to deliver brief counselling. Comparison group doctors received standard IPV information. Intervention patients were invited to receive counselling from their trained doctor. Comparison patients received usual care. Data were collected at baseline, 6 and 12 months. Path analysis tested mediation effects from trial arm to depression via self-efficacy, doctor support and safety enquiry at 6 and 12 months, controlling for baseline and abuse level.
RESULTS
At 6 months, mean perceived doctor support was higher for intervention than comparison patients and mediated depression effect. At 12 months, mean self-efficacy was higher for intervention than comparison patients and mediated depression effect. Mediation effects for doctor enquiry were non-significant.
CONCLUSIONS
Counselling by trained family doctors can help increase support and self-efficacy of women who have experienced IPV, mediating reduced depression.",2020,"Mediation effects for doctor enquiry were non-significant.
CONCLUSIONS
Counselling by trained family doctors can help increase support and self-efficacy of women who have experienced IPV, mediating reduced depression.","['women experiencing intimate partner violence (IPV', '272 female IPV survivors attending 52 Australian primary care clinics', 'counselling by family doctors for intimate partner violence']","['usual care', 'standard IPV information']","['mean perceived doctor support', 'mean self-efficacy', 'depression via self-efficacy, doctor support and safety enquiry']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",272.0,0.0861438,"Mediation effects for doctor enquiry were non-significant.
CONCLUSIONS
Counselling by trained family doctors can help increase support and self-efficacy of women who have experienced IPV, mediating reduced depression.","[{'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Valpied', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hegarty', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': ""O'doherty"", 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Coventry, UK.'}]",Family practice,['10.1093/fampra/cmz067']
376,31452038,Effects of a Required Large-Group Mindfulness Meditation Course on First-Year Medical Students' Mental Health and Quality of Life: a Randomized Controlled Trial.,"BACKGROUND
Teaching mindfulness techniques has been used in the attempt to prevent mental health problems in medical students. Although it has already shown promising results when offered to volunteers, the use as a required strategy is still controversial.
OBJECTIVES
To verify the efficacy of teaching mindfulness techniques to large groups when made part of a required discipline at the beginning of medical training.
DESIGN
Randomized controlled trial PARTICIPANTS: First-year medical students at the Federal University of Juiz de Fora, Brazil METHOD: Students were randomized into two groups: an intervention group (receiving a 6-week mindfulness protocol) and a control group (given a 6-week course containing organizational aspects of the medical school).
MAIN MEASURES
Intervention and control groups were compared on the levels of quality of life (WHOQOL-Bref), stress, anxiety and depression (DASS 21) and the facets of mindfulness (FFMQ) at baseline and at the end of the intervention.
RESULTS
A total of 141 students were included in the study, 70 in the intervention group and 71 in the control group. No significant differences were found between the intervention and control groups in all mental health, quality of life, and FFMQ scores (Cohen's d = 0.01 to 0.14). Likewise, no significant gains in mental health measures, quality of life, and FFMQ were identified in the intervention group when compared with the control group (Cohen's d = 0.02 to 0.33).
CONCLUSIONS
The incorporation of a required mindfulness course for large groups in the curriculum during the first semester of medical training was not associated with an improvement on medical students' mental health and quality of life.
CLINICAL TRIALS REGISTRATION
NCT03132597.",2020,"No significant differences were found between the intervention and control groups in all mental health, quality of life, and FFMQ scores (Cohen's d = 0.01 to 0.14).","[' First-year medical students at the Federal University of Juiz de Fora', 'A total of 141 students were included in the study, 70 in the intervention group and 71 in the control group', 'medical students', ""First-Year Medical Students' Mental Health and Quality of Life""]","['Required Large-Group Mindfulness Meditation Course', 'intervention group (receiving a 6-week mindfulness protocol) and a control group (given a 6-week course containing organizational aspects of the medical school']","[""medical students' mental health and quality of life"", 'levels of quality of life (WHOQOL-Bref), stress, anxiety and depression (DASS 21) and the facets of mindfulness (FFMQ', 'mental health measures, quality of life, and FFMQ', 'mental health, quality of life, and FFMQ scores']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034380'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0036378', 'cui_str': 'Schools, Medical'}]","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0332992,"No significant differences were found between the intervention and control groups in all mental health, quality of life, and FFMQ scores (Cohen's d = 0.01 to 0.14).","[{'ForeName': 'Afonso', 'Initials': 'A', 'LastName': 'Damião Neto', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Alessandra Lamas Granero', 'Initials': 'ALG', 'LastName': 'Lucchetti', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Oscarina', 'Initials': 'O', 'LastName': 'da Silva Ezequiel', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Lucchetti', 'Affiliation': 'School of Medicine, Federal University of Juiz de Fora, Juiz de Fora, MG, Brazil. g.lucchetti@yahoo.com.br.'}]",Journal of general internal medicine,['10.1007/s11606-019-05284-0']
377,32209712,Clinical Efficacy of Vibrating Mesh and Jet Nebulizers With Different Interfaces in Pediatric Subjects With Asthma.,"BACKGROUND
Nebulizers are commonly used in emergency departments to deliver bronchodilators to children with asthma exacerbations. However, no clinical study comparing a vibrating mesh nebulizer with a jet nebulizer is available in this patient population. The purpose of this study was to compare the clinical efficacy of a vibrating mesh nebulizer to a jet nebulizer combined with a mouthpiece or mask in children with asthma exacerbations admitted to the emergency department.
METHODS
We conducted a single-blinded randomized clinical trial of 217 children (2-18 y old) with a moderate to severe asthma exacerbation in the emergency department. Assessment of severity was defined by our acute asthma score, adapted from the Pediatric Asthma Score. Subjects were randomized to receive bronchodilator treatment via vibrating mesh nebulizer ( n = 108) or jet nebulizer ( n = 109) and were treated until they achieved a mild asthma score and were discharged or until a decision to admit was made. All subjects were treated per our acute asthma clinical pathway algorithm for the emergency department with modifications to allow for blinding, assessment of treatment, and data collection. Outcome variables included hospital admission rate, number of treatments, and time to mild asthma score.
RESULTS
There was a significant difference in baseline asthma score between subjects treated with the vibrating mesh nebulizer and those treated with the jet nebulizer ( P = .042), but no other significant differences in demographics existed between groups. To adjust for effect of baseline asthma score, a multiple logistic regression model was used to model admission. The vibrating mesh nebulizer group had a lower probability of being admitted to the hospital ( P = .062), and they required significantly fewer treatments ( P < .001) and less time to reach a mild asthma score ( P = .004) than those in the jet nebulizer group. In subjects with a mask interface, the vibrating mesh nebulizer significantly reduced the probability of admission ( P = .032).
CONCLUSIONS
Subjects treated with a vibrating mesh nebulizer required significantly fewer treatments and less time to achieve a mild asthma score. In subjects with a mask interface, the vibrating mesh nebulizer significantly reduced the probability of admission compared to jet nebulizer. (ClinicalTrials.gov registration NCT02774941.).",2020,"The vibrating mesh nebulizer group had a lower probability of being admitted to the hospital ( P = .062), and they required significantly fewer treatments ( P < .001) and less time to reach a mild asthma score ( P = .004) than those in the jet nebulizer group.","['217 children (2-18 y old) with a moderate to severe asthma exacerbation in the emergency department', 'children with asthma exacerbations admitted to the emergency department', 'Pediatric Subjects With Asthma', 'All subjects were treated per our acute asthma clinical pathway algorithm for the emergency department with modifications to allow for blinding, assessment of treatment, and data collection', 'children with asthma exacerbations']","['bronchodilator treatment via vibrating mesh nebulizer ( n = 108) or jet nebulizer', 'vibrating mesh nebulizer to a jet nebulizer combined with a mouthpiece or mask', 'Vibrating Mesh and Jet Nebulizers']","['probability of being admitted to the hospital', 'time to achieve a mild asthma score', 'baseline asthma score', 'time to reach a mild asthma score', 'probability of admission', 'clinical efficacy', 'hospital admission rate, number of treatments, and time to mild asthma score']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma (disorder)'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0002045'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0027524', 'cui_str': 'Nebulizers'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",217.0,0.0530595,"The vibrating mesh nebulizer group had a lower probability of being admitted to the hospital ( P = .062), and they required significantly fewer treatments ( P < .001) and less time to reach a mild asthma score ( P = .004) than those in the jet nebulizer group.","[{'ForeName': 'Gerald B', 'Initials': 'GB', 'LastName': 'Moody', 'Affiliation': ""Department of Respiratory Care, Children's Health - Children's Medical Center, Dallas, Texas. gerald.moody@childrens.com.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Luckett', 'Affiliation': 'Department of Pediatrics, Division of Critical Care Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Shockley', 'Affiliation': 'Department of Emergency Medicine, Division of Pediatric Emergency Medicine, UT Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ""Research Administration, Children's Health - Children's Medical Center, Dallas, Texas.""}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Ari', 'Affiliation': 'Department of Respiratory Care, Texas State University, Round Rock, Texas.'}]",Respiratory care,['10.4187/respcare.07538']
378,31820304,"Bioequivalence Evaluation of Three Pediatric Oral Formulations of Bilastine in Healthy Subjects: Results from a Randomized, Open Label, Crossover Study.","BACKGROUND AND OBJECTIVE
Bilastine is a non-sedating H1 antihistamine indicated for the treatment of allergic rhinoconjunctivitis and urticaria. The aim of this trial was to assess the bioequivalence of three novel pediatric oral formulations of bilastine.
METHODS
An open label, randomized, four-treatment-period, four-sequence, crossover, single-center study was conducted in 23 healthy volunteers. Each subject received four single doses of bilastine under fasting conditions: a 10-mg orodispersible tablet (DT1), a 10-mg oral solution (SOL), a 10-mg orodispersible tablet without water (DT2dry), and a 10-mg orodispersible tablet with water (DT2water, reference formulation). Blood samples were collected during 72 h with a washout period of at least 7 days. Bilastine maximum plasma concentration (C max ) and area under the plasma concentration-time curve between 0 to t time (AUC 0-t ) were calculated to assess bioequivalence. Tolerability was evaluated throughout the study.
RESULTS
The three oral pediatric formulations tested were bioequivalent to the reference formulation as determined by the ratio test/reference of the geometric mean and their 90% confidence intervals (between 0.80 and 1.25) for the C max , AUC 0-t and AUC 0-∞. Bilastine was well tolerated when administered indistinctly as an orodispersible tablet or as an oral solution.
CONCLUSION
The three oral pediatric formulations tested were found to be bioequivalent to the reference formulation. All formulations were well tolerated.
TRIAL REGISTRATION
Spanish Clinical Studies Registry (REEC) number 2014-000786-41.",2020,"All formulations were well tolerated.
","['23 healthy volunteers', 'Healthy Subjects']","['bilastine', 'Bilastine', 'bilastine under fasting conditions: a 10-mg orodispersible tablet (DT1), a 10-mg oral solution (SOL), a 10-mg orodispersible tablet without water (DT2dry), and a 10-mg orodispersible tablet with water (DT2water, reference formulation']","['Blood samples', 'tolerated', 'Tolerability', 'Bilastine maximum\xa0plasma concentration (C max ) and area under the plasma concentration-time curve']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C2960508', 'cui_str': 'Conventional release orodispersible tablet'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",23.0,0.0520251,"All formulations were well tolerated.
","[{'ForeName': 'Belén', 'Initials': 'B', 'LastName': 'Sádaba', 'Affiliation': 'Clinical Pharmacology Service, Clínica Universidad de Navarra, Pamplona, Navarra, Spain. bsadaba@unav.es.'}, {'ForeName': 'Jose Ramón', 'Initials': 'JR', 'LastName': 'Azanza', 'Affiliation': 'Clinical Pharmacology Service, Clínica Universidad de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Aintzane', 'Initials': 'A', 'LastName': 'García-Bea', 'Affiliation': 'Medical Department, Faes Farma S. A., Leioa, Biscay, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Labeaga', 'Affiliation': 'Medical Department, Faes Farma S. A., Leioa, Biscay, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Campo', 'Affiliation': 'Clinical Research Department, Faes Farma S. A., Leioa, Biscay, Spain.'}, {'ForeName': 'Román', 'Initials': 'R', 'LastName': 'Valiente', 'Affiliation': 'Clinical Research Department, Faes Farma S. A., Leioa, Biscay, Spain.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-019-00596-2']
379,31898142,Capsule Commentary on Neto et al.: Effects of a Required Large-Group Mindfulness Meditation Course on First-Year Medical Students' Mental Health and Quality of Life: a Randomized Controlled Trial.,,2020,,"[""First-Year Medical Students' Mental Health and Quality of Life""]",['Required Large-Group Mindfulness Meditation Course'],[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034380'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",[],,0.0929093,,"[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Padrino', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH, USA. Susan.padrino@uhhospitals.org.'}]",Journal of general internal medicine,['10.1007/s11606-019-05382-z']
380,32405121,Does moral reasoning influence public values for health care priority setting?: A population-based randomized stated preference survey.,"OBJECTIVE
Preferences of members of the public are recognized as important inputs into health care priority-setting, though knowledge of such preferences is scant. We sought to generate evidence of public preferences related to healthcare resource allocation among adults and children.
METHODS
We conducted an experimental stated preference survey in a national sample of Canadian adults. Preferences were elicited across a range of scenarios and scored on a visual analogue scale. Intervention group participants were randomized to a moral reasoning exercise prior to each choice task. The main outcomes were the differences in mean preference scores by group, scenario, and demographics.
RESULTS
Our results demonstrate a consistent preference by participants to allocate scarce health system resources to children. Exposure to the moral reasoning exercise weakened but did not eliminate this preference. Younger respondent age and parenthood were associated with greater preference for children. The top principles guiding participants' allocative decisions were treat equally, relieve suffering, and rescue those at risk of dying.
CONCLUSIONS
Our study affirms the relevance of age in public preferences for the allocation of scarce health care resources, demonstrating a significant preference by participants to allocate healthcare resources to children. However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access. Definitions of value in healthcare based on clinical benefit and cost-effectiveness may exclude moral considerations that the public values, such as equality and humanitarianism, highlighting opportunities to enrich healthcare priority-setting through public engagement.",2020,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","['experimental stated preference survey in a national sample of Canadian adults', 'adults and children']","['moral reasoning exercise', 'moral reasoning exercise prior to each choice task']","['mean preference scores by group, scenario, and demographics']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0701692,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","[{'ForeName': 'Avram E', 'Initials': 'AE', 'LastName': 'Denburg', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, M5G 1X8, Canada. Electronic address: avram.denburg@sickkids.ca.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Ungar', 'Affiliation': 'Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, M5T 3M6, Canada.'}, {'ForeName': 'Shiyi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Biostatistician, Biostatistics, Design and Analysis, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, M5G 1X8, Canada.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Hurley', 'Affiliation': 'Department of Economics, McMaster University, Hamilton, L8S 4L8, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Abelson', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, L8S 4L8, Canada.'}]","Health policy (Amsterdam, Netherlands)",['10.1016/j.healthpol.2020.04.007']
381,32212342,Nucleus Hybrid S12: Multicenter Clinical Trial Results.,"OBJECTIVES/HYPOTHESIS
The use of a short 10-mm/10-electrode cochlear implant to preserve low-frequency residual hearing was investigated. This report describes the 12-month outcomes of this multicenter clinical trial.
STUDY DESIGN
Single-subject design.
METHODS
Twenty-eight subjects with low-frequency hearing at or better than 60 dB HL at 500 Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear. Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences was collected pre- and postoperatively at 3, 6, and 12 months. Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire was also collected pre- and postoperatively.
RESULTS
Functional hearing preservation was accomplished in 96% of subjects. At 3 and 6 months, 86% of the 28 subjects had maintained functional hearing. By 12 months, 23 out of 27 subjects (85%) had maintained functional hearing (one subject with functional hearing at 6 months withdrew from the study prior to the 12-month visit). Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids. Furthermore, preoperative to 12 months postoperative subjective ratings showed significant improvements for the SSQ.
CONCLUSIONS
This study demonstrates that a high degree of hearing preservation enabling acoustic-electric hearing and improvement in speech understanding in quiet and in noise can be accomplished using a short-electrode 10-mm cochlear implant.
LEVEL OF EVIDENCE
2c Laryngoscope, 130:E548-E558, 2020.",2020,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"['Nucleus Hybrid S12', 'Twenty-eight subjects with low-frequency hearing at or better than 60\u2009dB HL at 500\u2009Hz and severe high-frequency hearing loss were implanted with a Nucleus Hybrid S12 implant in their poorer ear']",['hearing preservation enabling acoustic-electric hearing'],"['Subjective reporting using the Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire', 'Functional hearing preservation', 'Speech perception', 'Speech perception in quiet using Consonant-Nucleus-Consonant (CNC) words and sentences in noise using AzBio sentences', 'maintained functional hearing', 'everyday listening condition']","[{'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439498', 'cui_str': 'decibel hearing level'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018780', 'cui_str': 'Hearing Loss, High-Frequency'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}]","[{'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0037826', 'cui_str': 'Speech Perception'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",28.0,0.0168716,Speech perception results demonstrated that 81% of the participants on CNC words and 77% with AzBio sentences in noise had significant improvements using their everyday listening condition at 12 months compared to preoperative performance with bilateral hearing aids.,"[{'ForeName': 'Camille C', 'Initials': 'CC', 'LastName': 'Dunn', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Cochlear Americas, Centennial, Colorado, U.S.A.'}, {'ForeName': 'Marlan R', 'Initials': 'MR', 'LastName': 'Hansen', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Gantz', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of Iowa, Iowa City, Iowa.'}]",The Laryngoscope,['10.1002/lary.28628']
382,32212395,Optimizing Retention in a Pragmatic Trial of Community-Living Older Persons: The STRIDE Study.,"OBJECTIVES
The Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study is testing the effectiveness of a multifactorial intervention to prevent serious fall injuries. Our aim was to describe procedures that were implemented to optimize participant retention; report retention yields by age, sex, clinical site, and follow-up time; provide reasons for study withdrawals; and highlight the successes and lessons learned from the STRIDE retention efforts.
DESIGN
Pragmatic cluster randomized trial.
SETTING
A total of 86 primary care practices within 10 US healthcare systems.
PARTICIPANTS
A total of 5451 community-living persons, 70 years of age or older, at high risk for serious fall injuries.
MEASUREMENTS
Study outcomes were collected every 4 months by a central call center. Reconsent was required to extend follow-up beyond the originally planned 36 months.
RESULTS
Over a median follow-up of 3.2 years (interquartile range = 2.8-3.7 y), 439 (8.1%) participants died and 600 (11.0%) withdrew their consent or did not reconsent to extend follow-up beyond 36 months, yielding rates (per 100 person-years) of deaths and withdrawals of 2.6 and 3.6, respectively. The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site. The most common reasons for withdrawal were illness and unable to contact for reconsent at 36 months. Completion of the follow-up interviews was greater than 93% at each time point. Most participants completed all (71.8%) or all but one (9.2%) of the follow-up interviews. The most common reason for not completing a follow-up interview was unable to contact, with rates ranging from 2.8% at 40 months to 4.6% at 20 months.
CONCLUSION
Completion of the thrice-yearly follow-up interviews in STRIDE was high, and retention of participants over 44 months exceeded the original projections. The procedures used in STRIDE, together with lessons learned, should assist other investigators who are planning or conducting large pragmatic trials of vulnerable older persons. J Am Geriatr Soc 68:1242-1249, 2020.",2020,"The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site.","['A total of 86 primary care practices within 10 US healthcare systems', 'Community-Living Older Persons', 'A total of 5451 community-living persons, 70\u2009years of age or older, at high risk for serious fall injuries', 'vulnerable older persons']",['multifactorial intervention'],['withdrawal rate'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1301836', 'cui_str': 'Falling injury (disorder)'}]",[],[],5451.0,0.0806889,"The withdrawal rate increased with advancing age, was comparable for men and women, and did not differ much by clinical site.","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'McGloin', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Shelton', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Luann M', 'Initials': 'LM', 'LastName': 'Bianco', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Eleni A', 'Initials': 'EA', 'LastName': 'Skokos', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Latham', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Linda V', 'Initials': 'LV', 'LastName': 'Nyquist', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Wallace', 'Affiliation': 'University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Martha B', 'Initials': 'MB', 'LastName': 'Carnie', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Dykes', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Goehring', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Doyle', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Charpentier', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Erich J', 'Initials': 'EJ', 'LastName': 'Greene', 'Affiliation': 'Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, Connecticut.'}, {'ForeName': 'Katy L', 'Initials': 'KL', 'LastName': 'Araujo', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16356']
383,31900543,"Aripiprazole for prevention of delirium in the neurosurgical intensive care unit: a double-blind, randomized, placebo-controlled study.","PURPOSE
Delirium is reported in over 50% of critically ill ICU patients, and is associated with increased mortality and long-term cognitive consequences. Prevention and early management of delirium are essential components of ICU care. However, pharmacological interventions have not been effective in delirium prevention. This study investigated the effect of aripiprazole in the prevention of delirium in a neurosurgical intensive care unit.
METHODS
In this prospective, randomized placebo-controlled small clinical trial, 53 patients, 18 to 80 years old, were randomized to receive enteric aripiprazole (15 mg) or placebo for up to 7 days. Delirium, detected by the Confusion Assessment Method-ICU, ICU events, laboratory studies, aripiprazole safety, time to delirium onset, delirium-free days, delirium prevalence during follow-up and ICU length of stay were recorded.
RESULTS
Forty patients with similar baseline characteristics, including age, sex, neurosurgery types and APACHE II scores, completed the study. Delirium incidence and the mean days to its onset were 20% vs. 55% (p = 0.022) and 2.17 ± 0.41 vs. 2.09 ± 0.30 (p = 0.076) in the aripiprazole and placebo groups, respectively. The mean number of delirium-free days were: 5.6 (95%CI, 4.6-6.5) and 4.3 (95%CI, 3.2-5.4), in aripiprazole and placebo groups, respectively (p = 0.111). The prevalence of delirium during the follow-up was significantly lower in the aripiprazole group (p = 0.018). Serious aripiprazole adverse reactions were not observed.
CONCLUSIONS
Aripiprazole can reduce the incidence of delirium in the neurosurgical ICU. Studies with larger sample size in diverse ICU settings and longer follow-up are needed to confirm our findings.",2020,"Delirium incidence and the mean days to its onset were 20% vs. 55% (p = 0.022) and 2.17 ± 0.41 vs. 2.09 ± 0.30 (p = 0.076) in the aripiprazole and placebo groups, respectively.","['Forty patients with similar baseline characteristics, including age, sex, neurosurgery types and APACHE II scores, completed the study', '53 patients, 18 to 80 years old']","['placebo', 'enteric aripiprazole', 'aripiprazole', 'Aripiprazole']","['mean number of delirium-free days', 'prevalence of delirium', 'Serious aripiprazole adverse reactions', 'Delirium incidence and the mean days to its onset', 'Confusion Assessment Method-ICU, ICU events, laboratory studies, aripiprazole safety, time to delirium onset, delirium-free days, delirium prevalence during follow-up and ICU length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",53.0,0.473176,"Delirium incidence and the mean days to its onset were 20% vs. 55% (p = 0.022) and 2.17 ± 0.41 vs. 2.09 ± 0.30 (p = 0.076) in the aripiprazole and placebo groups, respectively.","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Imam Hossein Teaching and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farasatinasab', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy-International Campus. Firoozgar Clinical Research Development Center (FCRDC), Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Jafarpour Machian', 'Affiliation': 'Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghorbani', 'Affiliation': 'Department of Neurosurgery, Firoozgar Teaching and Educational Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Mahmood', 'Initials': 'SM', 'LastName': 'Ramak Hashemi', 'Affiliation': 'Department of Neurosurgery, Firoozgar Teaching and Educational Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Nikoobakht', 'Affiliation': 'Department of Neurosurgery, Firoozgar Clinical Research Development Center (FCRDC), Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Golchin', 'Affiliation': 'Department of Neurosurgery, Firoozgar Teaching and Educational Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholamhasan', 'Initials': 'G', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Neurosurgery, Firoozgar Clinical Research Development Center (FCRDC), Iran University of Medical Sciences, Firoozgar Teaching and Educational Center, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sistanizad', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. sistanizadm@sbmu.ac.ir.'}]",European journal of clinical pharmacology,['10.1007/s00228-019-02802-1']
384,32207075,Brentuximab Vedotin for Treating Relapsed or Refractory CD30-Positive Cutaneous T-Cell Lymphoma: An Evidence Review Group Perspective of a NICE Single Technology Appraisal.,"As part of the single technology appraisal process, the National Institute for Health and Care Excellence invited Takeda UK Ltd to submit clinical- and cost-effectiveness evidence for brentuximab vedotin (BV) for treating relapsed or refractory CD30-positive (CD30+) cutaneous T-cell lymphoma (CTCL). The Liverpool Reviews and Implementation Group at the University of Liverpool was commissioned to act as the evidence review group (ERG). This article summarises the ERG's review of the company's submission for BV and the appraisal committee (AC) decision. The principal clinical evidence was derived from a subgroup of patients with advanced-stage CD30+ mycosis fungoides (MF) or primary cutaneous anaplastic large-cell lymphoma (pcALCL) in the phase III ALCANZA randomised controlled trial (RCT). This trial compared BV versus physician's choice (PC) of methotrexate or bexarotene. Evidence from three observational studies was also presented, which included patients with other CTCL subtypes. The ERG's main concerns with the clinical evidence were the lack of RCT evidence for CTCL subtypes other than MF or pcALCL, lack of robust overall survival data (data were immature and confounded by subsequent treatment and treatment crossover on disease progression) and lack of conclusive results from analyses of health-related quality-of-life data. The ERG noted that many areas of uncertainty in the cost-effectiveness analysis were related to the clinical data, arising from the rarity of the condition and its subtypes and the complexity of the treatment pathway. The ERG highlighted that the inclusion of allogeneic stem-cell transplant (alloSCT) as an option in the treatment pathway was based on weak evidence and generated more uncertainty in a disease area that, because of its rarity and diversity, was already highly uncertain. The ERG also lacked confidence in the company's modelling of the post-progression pathway and was concerned that it may not produce reliable results. Results from the company's base-case comparison (including a simple discount patient access scheme [PAS] for BV) showed that treatment with BV dominated PC. The ERG's revisions and scenario analyses highlighted the high level of uncertainty around the company base-case cost-effectiveness results, ranging from BV dominating PC to an incremental cost-effectiveness ratio per quality-adjusted life-year gained of £494,981. The AC concluded that it was appropriate to include alloSCT in the treatment pathway even though data were limited. The AC recommended BV as an option for treating CD30+ CTCL after at least one systemic therapy in adults if they have MF, stage IIB or higher pcALCL or Sézary syndrome and if the company provides BV according to the commercial arrangement (i.e. simple discount PAS).",2020,"The ERG's revisions and scenario analyses highlighted the high level of uncertainty around the company base-case cost-effectiveness results, ranging from BV dominating PC to an incremental cost-effectiveness ratio per quality-adjusted life-year gained of £494,981.","['patients with other CTCL subtypes', 'Refractory CD30-Positive Cutaneous T-Cell Lymphoma', 'patients with advanced-stage CD30+ mycosis fungoides (MF) or primary cutaneous anaplastic large-cell lymphoma (pcALCL) in the phase III']","['methotrexate or bexarotene', 'Brentuximab Vedotin']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C3888910', 'cui_str': 'CD30 positive'}, {'cui': 'C0079773', 'cui_str': 'Lymphoma, T-Cell, Cutaneous'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0026948', 'cui_str': 'Mycosis Fungoides'}, {'cui': 'C1301362', 'cui_str': 'Primary Cutaneous CD30-positive Large T-Cell Lymphoma'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0765273', 'cui_str': 'bexarotene'}, {'cui': 'C2973446', 'cui_str': 'brentuximab vedotin'}]",[],,0.0673697,"The ERG's revisions and scenario analyses highlighted the high level of uncertainty around the company base-case cost-effectiveness results, ranging from BV dominating PC to an incremental cost-effectiveness ratio per quality-adjusted life-year gained of £494,981.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stainthorpe', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Fleeman', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK. nigel.fleeman@liverpool.ac.uk.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Houten', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Marty', 'Initials': 'M', 'LastName': 'Chaplin', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Boland', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Beale', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Yenal', 'Initials': 'Y', 'LastName': 'Dundar', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Whelan Building, Brownlow Hill, Liverpool, L69 3GB, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McEntee', 'Affiliation': 'North West Medicines Information Centre, Liverpool, L69 3GF, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Faculty of Health and Life Sciences, University of Liverpool, Thompson Yates Building, Liverpool, L69 3GB, UK.'}]",PharmacoEconomics - open,['10.1007/s41669-020-00203-0']
385,31791039,Mechanistic link between right prefrontal cortical activity and anxious arousal revealed using transcranial magnetic stimulation in healthy subjects.,"Much of the mechanistic research on anxiety focuses on subcortical structures such as the amygdala; however, less is known about the distributed cortical circuit that also contributes to anxiety expression. One way to learn about this circuit is to probe candidate regions using transcranial magnetic stimulation (TMS). In this study, we tested the involvement of the dorsolateral prefrontal cortex (dlPFC), in anxiety expression using 10 Hz repetitive TMS (rTMS). In a within-subject, crossover experiment, the study measured anxiety in healthy subjects before and after a session of 10 Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC). It used threat of predictable and unpredictable shock to induce anxiety and anxiety potentiated startle to assess anxiety. Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS. These results suggest a mechanistic link between right dlPFC activity and physiological anxiety expression. This result supports current models of prefrontal asymmetry in affect, and lays the groundwork for further exploration into the cortical mechanisms mediating anxiety, which may lead to novel anxiety treatments.",2020,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","['healthy subjects before and after a session of 10\u2009Hz rTMS to the right dorsolateral prefrontal cortex (dlPFC', 'healthy subjects']","['10\u2009Hz repetitive TMS (rTMS', 'transcranial magnetic stimulation', 'transcranial magnetic stimulation (TMS']",['anxiety-potentiated startle'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0546911', 'cui_str': 'To the right (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0106782,"Counter to our hypotheses, results showed an increase in anxiety-potentiated startle following active but not sham rTMS.","[{'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nicholas.balderston@pennmedicine.upenn.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Beydler', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Radman', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Luber', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Noninvasive Neuromodulation Unit, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0583-5']
386,30980122,Effect of increasing doses of cystine-binding thiol drugs on cystine capacity in patients with cystinuria.,"Appropriate dosing of cystine-binding thiol drugs in the management of cystinuria has been based on clinical stone activity. When new stones form, the dose is increased. Currently, there is no method of measuring urinary drug levels to guide the titration of therapy. Increasing cystine capacity, a measure of cystine solubility, has been promoted as a method of judging the effects of therapy. In this study, we gave increasing doses of tiopronin or D-penicillamine, depending on the patients' own prescriptions, to ten patients with cystinuria and measured cystine excretion and cystine capacity. The doses were 0, 1, 2, 3 g per day, given in two divided doses, and administered in a random order. Going from 0 to 1 g/day led to an increase in cystine capacity from - 39.1 to 130.4 mg/L (P < 0.009) and decreased 24 h cystine excretion from 1003.9 to 834.8 mg/day (P = 0.039). Increasing the doses from 1 to 2 to 3 g/day had no consistent or significant effect to further increase cystine capacity or decrease cystine excretion. Whether doses higher than 1 g/day have additional clinical benefit is not clear from this study. Limiting doses might be associated with fewer adverse effects without sacrificing the benefit of higher doses if higher doses do not offer clinical importance. However, trials with stone activity as an outcome would be desirable.",2019,Increasing the doses from 1 to 2 to 3 g/day had no consistent or significant effect to further increase cystine capacity or decrease cystine excretion.,['patients with cystinuria'],"['cystine-binding thiol drugs', 'tiopronin or D-penicillamine']","['cystine excretion and cystine capacity', 'cystine capacity', '24\xa0h cystine excretion', 'cystine capacity or decrease cystine excretion']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010691', 'cui_str': 'Cystinuria'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0038734', 'cui_str': 'Mercaptans'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0025405', 'cui_str': 'tiopronin'}, {'cui': 'C0030817', 'cui_str': 'Penicillamine'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C1291162', 'cui_str': 'Decreased cystine'}]",10.0,0.029658,Increasing the doses from 1 to 2 to 3 g/day had no consistent or significant effect to further increase cystine capacity or decrease cystine excretion.,"[{'ForeName': 'Deepa A', 'Initials': 'DA', 'LastName': 'Malieckal', 'Affiliation': 'Division of Nephrology, Department of Medicine, Hofstra Northwell School of Medicine, Hempstead, NY, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Modersitzki', 'Affiliation': 'Nephrology Division, NYU Langone Medical Center, New York, NY, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mara', 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Felicity T', 'Initials': 'FT', 'LastName': 'Enders', 'Affiliation': 'Biomedical Statistics & Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Asplin', 'Affiliation': 'Litholink Corp, Laboratory Corporation of America® Holdings, Chicago, IL, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldfarb', 'Affiliation': 'Nephrology Division, NYU Langone Medical Center, New York, NY, USA. david.goldfarb@nyumc.org.'}]",Urolithiasis,['10.1007/s00240-019-01128-y']
387,31749028,"Impact of a Low-Intensity Resource Referral Intervention on Patients' Knowledge, Beliefs, and Use of Community Resources: Results from the CommunityRx Trial.","BACKGROUND
Connecting patients to community-based resources is now a cornerstone of modern healthcare that supports self-management of health. The mechanisms that link resource information to behavior change, however, remain poorly understood.
OBJECTIVE
To evaluate the impact of CommunityRx, an automated, low-intensity resource referral intervention, on patients' knowledge, beliefs, and use of community resources.
DESIGN
Real-world controlled clinical trial at an urban academic medical center in 2015-2016; participants were assigned by alternating week to receive the CommunityRx intervention or usual care. Surveys were administered at baseline, 1 week, 1 month, and 3 months.
PARTICIPANTS
Publicly insured adults, ages 45-74 years.
INTERVENTION
CommunityRx generated an automated, personalized list of resources, known as HealtheRx, near each participant's home using condition-specific, evidence-based algorithms. Algorithms used patient demographic and health characteristics documented in the electronic health record to identify relevant resources from a comprehensive, regularly updated database of health-related resources in the study area.
MAIN MEASURES
Using intent-to-treat analysis, we examined the impact of HealtheRx referrals on (1) knowledge of the most commonly referred resource types, including healthy eating classes, individual counseling, mortgage assistance, smoking cessation, stress management, and weight loss classes or groups, and (2) beliefs about having resources in the community to manage health.
KEY RESULTS
In a real-world controlled trial of 374 adults, intervention recipients improved knowledge (AOR = 2.15; 95% CI, 1.29-3.58) and beliefs (AOR = 1.68; 95% CI, 1.07-2.64) about common resources in the community to manage health, specifically gaining knowledge about smoking cessation (AOR = 2.76; 95% CI, 1.07-7.12) and weight loss resources (AOR = 2.26; 95% CI 1.05-4.84). Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
CONCLUSIONS
In a middle-age and older population with high morbidity, a low-intensity health IT intervention to deliver resource referrals promoted behavior change by increasing knowledge and positive beliefs about community resources for self-management of health.
NIH TRIAL REGISTRY
NCT02435511.",2020,"Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
","['urban academic medical center in 2015-2016; participants', 'Publicly insured adults, ages 45-74\xa0years', 'healthy eating classes, individual counseling, mortgage assistance, smoking cessation, stress management, and weight loss classes or groups, and (2)\xa0beliefs about having resources in the community to manage health', '374 adults']","['Low-Intensity Resource Referral Intervention', 'CommunityRx intervention or usual care']","['knowledge', 'weight loss resources']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Referral'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",374.0,0.0757793,"Positive changes in both knowledge and beliefs about community resources were associated with higher resource use (P = 0.02).
","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Tung', 'Affiliation': 'Section of General Internal Medicine, University of Chicago, Chicago, IL, USA. eliztung@uchicago.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Abramsohn', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Boyd', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Makelarski', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Beiser', 'Affiliation': 'Section of Emergency Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chiahung', 'Initials': 'C', 'LastName': 'Chou', 'Affiliation': 'Department of Health Outcomes Research and Policy, Auburn University, Auburn, AL, USA.'}, {'ForeName': 'Elbert S', 'Initials': 'ES', 'LastName': 'Huang', 'Affiliation': 'Section of General Internal Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ozik', 'Affiliation': 'Consortium for Advanced Science and Engineering, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Chaitanya', 'Initials': 'C', 'LastName': 'Kaligotla', 'Affiliation': 'Consortium for Advanced Science and Engineering, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Stacy Tessler', 'Initials': 'ST', 'LastName': 'Lindau', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Chicago, Chicago, IL, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05530-5']
388,32205677,Sprint and Strength Training Modulates Autophagy and Proteostasis in Aging Sprinters.,"PURPOSE
Exercise and aging may modulate muscle protein homeostasis and autophagy, but few studies examine highly trained middle-age or older individuals. This study elucidated the effects of a new long-term training stimulus on markers of muscle autophagy and unfolded protein response (UPR) and on sprint running performance in masters sprinters.
METHODS
Thirty-two male competitive sprinters (age 40-76 yr) were randomly divided into experimental (EX) and control (CTRL) groups. The EX training program was a combination of heavy and explosive strength and sprint exercises aimed at improving sprint performance. Fifteen and thirteen participants completed the 20-wk intervention period in EX and CTRL, respectively. The latter were told to continue their routine exercises. Key protein markers were analyzed by Western blotting from vastus lateralis (VL) muscle biopsies. The muscle thickness of VL was analyzed by ultrasonography and sprint performance by a 60-m running test.
RESULTS
EX induced improvement in 60-m sprint performance when compared with controls (time-group, P = 0.003) without changes in VL muscle thickness. Content of lipidated microtubule-associated protein 1A/1B-light chain 3 (LC3-II) increased in EX (P = 0.022), suggesting increased autophagosome content. In addition, an autophagosome clearance marker sequestosome 1 (p62) decreased in EX (P = 0.006). Markers of UPR selectively modulated with decreases (e.g., ATF4, P = 0.003) and increases (e.g., EIF2α, P = 0.019) observed in EX.
CONCLUSIONS
These findings suggest that a new intensive training stimulus that combines strength training with sprint training may increase muscle autophagosome content in a basal state without any evidence of impaired autophagosome clearance in masters sprinters. Simultaneously, the combined training may have a selective effect on the content of UPR signaling components.",2020,"RESULTS
EX induced improvement in 60-meter sprint performance when compared to controls (time x group, P = 0.003) without changes in VL muscle thickness.","['Thirty-two male competitive sprinters (aged 40-76 years', 'highly-trained middle-aged or older individuals', 'masters sprinters']","['experimental (EX) and control (CTRL', 'Sprint and Strength Training']","['Muscle thickness of VL', 'markers of muscle autophagy and unfolded protein response (UPR', '60-meter sprint performance', 'VL muscle thickness']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C1155342', 'cui_str': 'Unfolded Protein Response'}, {'cui': 'C0475209', 'cui_str': 'm'}]",32.0,0.01632,"RESULTS
EX induced improvement in 60-meter sprint performance when compared to controls (time x group, P = 0.003) without changes in VL muscle thickness.","[{'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'HentilÄ', 'Affiliation': '1Faculty of Sport and Health Sciences, Neuromuscular Research Center, University of Jyväskylä, Jyväskylä, FINLAND 2Faculty of Sport and Health Sciences, Gerontology Research Center, University of Jyväskylä, Jyväskylä, FINLAND 3Department of Physiology, Faculty of Medicine, University of Helsinki, Helsinki, FINLAND 4Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, FINLAND.'}, {'ForeName': 'Juha J', 'Initials': 'JJ', 'LastName': 'Hulmi', 'Affiliation': ''}, {'ForeName': 'Eija K', 'Initials': 'EK', 'LastName': 'Laakkonen', 'Affiliation': ''}, {'ForeName': 'Juha P', 'Initials': 'JP', 'LastName': 'Ahtiainen', 'Affiliation': ''}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Suominen', 'Affiliation': ''}, {'ForeName': 'Marko T', 'Initials': 'MT', 'LastName': 'Korhonen', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002340']
389,31255587,A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age.,"PURPOSE
To compare visual acuity (VA) and binocularity outcomes in moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation.
DESIGN
Prospective randomized clinical trial (RCT).
METHODS
One hundred nineteen 3- to 5-year-old children with hyperopia between +3.00D and +6.00D spherical equivalent were randomly assigned to glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus). Follow-up occurred every 6 months. At 3 years, the treatment strategy was classified as ""failed"" if any of the following were met, both with and without correction: subnormal distance VA or stereoacuity; manifest strabismus; or strabismus surgery during follow-up.
RESULTS
Of 84 (71%) children who completed the primary outcome examination, failure occurred in five (12%; 95% confidence interval [CI]: 4%-26%) of 41 assigned to glasses and four (9%; 95% CI: 3%-22%) of 43 assigned to observation (difference = 3%; 95% CI: -12%-18%; P = .72). Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI: 19%-43%) assigned to glasses and 27% (95% CI: 17%-42%) assigned to observation.
CONCLUSIONS
In an RCT comparing glasses to observation for moderately hyperopic 3- to 5-year-old children with normal VA and binocularity, failure for VA or binocularity was not common. With insufficient enrollment and retention, our study was unable to determine whether immediate glasses prescription reduces failure rate, but low failure rates suggest that immediate glasses prescription for these children may not be needed to prevent failure for VA and/or binocularity.",2019,"Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI = 19% to 43%) assigned to glasses and 27% (95% CI = 17% to 42%) assigned to observation.
","[' 119 3- to 5-year-olds with hyperopia between +3.00 diopters (D) and +6.00D spherical equivalent', 'moderately hyperopic children with normal VA and binocularity assigned to glasses versus observation', 'Moderate Hyperopia in Children 3 to 5 Years of Age']","['Delayed Glasses', 'strabismus surgery during follow-up', 'glasses versus observation (with glasses prescribed if deteriorated for subnormal distance VA or near stereoacuity, or manifest strabismus']",['failure'],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0020490', 'cui_str': 'Hypermetropia'}, {'cui': 'C0439486', 'cui_str': 'Diopters - (qualifier value)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C1705868', 'cui_str': 'Strabismus surgery'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity (observable entity)'}, {'cui': 'C0205319', 'cui_str': 'Manifest (qualifier value)'}, {'cui': 'C0038379', 'cui_str': 'Phorias'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.477695,"Deterioration prior to 3 years (requiring glasses per protocol) occurred in 29% (95% CI = 19% to 43%) assigned to glasses and 27% (95% CI = 17% to 42%) assigned to observation.
","[{'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Holmes', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA. Electronic address: pedig@jaeb.org.'}, {'ForeName': 'Marjean T', 'Initials': 'MT', 'LastName': 'Kulp', 'Affiliation': 'College of Optometry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Trevano W', 'Initials': 'TW', 'LastName': 'Dean', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Donny W', 'Initials': 'DW', 'LastName': 'Suh', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Kraker', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Wallace', 'Affiliation': 'Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Petersen', 'Affiliation': 'Rocky Mountain Eye Care Associates, Salt Lake City, Utah, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry at Marshall B. Ketchum University, Fullerton, California, USA.'}, {'ForeName': 'Earl R', 'Initials': 'ER', 'LastName': 'Crouch', 'Affiliation': 'Virginia Pediatric Eye Center, Norfolk, Virginia, USA.'}, {'ForeName': 'Ingryd J', 'Initials': 'IJ', 'LastName': 'Lorenzana', 'Affiliation': 'Advanced Vision Center, Schaumburg, Illinois, USA.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Ticho', 'Affiliation': 'Ticho Eye Associates, Chicago Ridge, Illinois, USA.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Verderber', 'Affiliation': 'Pediatric Eye Associates, Wilmette, Illinois, USA.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Weise', 'Affiliation': 'University of Alabama School of Optometry, Birmingham, Alabama, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2019.06.021']
390,30308286,Monitoring alcohol use in heavy drinking soup kitchen attendees.,"Rates of heavy alcohol use in soup kitchen attendees range from 30% to 38%, but these data are based entirely on self-reported drinking. Little is known about the intensity or frequency of drinking in this population. We assessed alcohol use transdermally every 30 min over a 3-week period among heavy drinkers who attended local soup kitchens. In addition to transdermal alcohol monitoring, participants were randomly assigned to daily breath alcohol monitoring with or without reinforcement for alcohol-negative breath samples (BrAC). Analyses assessed feasibility of transdermal monitoring and examined alcohol use based on BrAC, transdermal, and self-report data, as well as effect sizes for these metrics based on group assignment. Nineteen participants completed the 21-day monitoring period in full; three persons removed the anklet 3-16 days early due to hospitalization, impending hospitalization, or incarceration. Participants reported minimal impacts of the monitors, and severity ratings of side effects were mild. When using BrAC, transdermal, and self-report data, the percentage of non-drinking days was 93%, 58%, and 57%, and the longest duration of consecutive non-drinking days averaged 10.3, 7.2, and 5.7 days, respectively. About half of drinking days involved heavy drinking (5 + drinks). Self-report and transdermal drinking days correlated significantly, p < .001, but neither index was associated with BrAC. Group comparisons indicate small-to-moderate sized effects of reinforcement compared to no reinforcement for increasing the proportion of alcohol-negative breath samples and durations of consecutive non-drinking samples during the study when BrAC was the metric. Transdermal data and self-report data indicated a more complex pattern. Reinforcement participants drank more often but at lower quantities than monitoring (control) participants per both transdermal and self-report data. These data suggest that transdermal monitors are well tolerated and document substantial heavy drinking in this population. Soup kitchens users are in need of alcohol interventions, and soup kitchens may represent a novel opportunistic setting for intervention delivery for an important and growing health disparities population.",2019,"Self-report and transdermal drinking days correlated significantly, p < .001, but neither index was associated with BrAC.","['Heavy Drinking Soup Kitchen Attendees', 'Nineteen participants completed the 21-day monitoring period in full; three persons removed the anklet 3-16 days early due to hospitalization, impending hospitalization, or incarceration', 'heavy drinkers who attended local soup kitchens']",['daily breath alcohol monitoring with or without reinforcement for alcohol-negative breath samples (BrAC'],['heavy drinking'],"[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0453399', 'cui_str': 'Soup (substance)'}, {'cui': 'C0557653', 'cui_str': 'Kitchen (environment)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0179081', 'cui_str': 'Anklet'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0332190', 'cui_str': 'Impending (qualifier value)'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment (finding)'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0277982', 'cui_str': 'Smell of alcohol on breath (finding)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",19.0,0.0139378,"Self-report and transdermal drinking days correlated significantly, p < .001, but neither index was associated with BrAC.","[{'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Rash', 'Affiliation': 'UConn Health School of Medicine, Farmington, CT, United States. Electronic address: Carlarash@gmail.com.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Petry', 'Affiliation': 'UConn Health School of Medicine, Farmington, CT, United States.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Alessi', 'Affiliation': 'UConn Health School of Medicine, Farmington, CT, United States.'}, {'ForeName': 'Nancy P', 'Initials': 'NP', 'LastName': 'Barnett', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, RI, United States.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2018.10.001']
391,31759333,Single and repeated ketamine infusions for reduction of suicidal ideation in treatment-resistant depression.,"Repeated administration of subanesthetic intravenous ketamine may prolong the rapid decrease in suicidal ideation (SI) elicited by single infusions. The purpose of this secondary analysis was to evaluate reduction in SI with a single ketamine infusion compared with an active control, and prolonged suppression of SI with repeated and maintenance infusions. Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single ketamine infusion during a randomized, double-blind crossover with midazolam. Following relapse of depressive symptoms, participants received six open-label ketamine infusions administered thrice-weekly over 2 weeks. Antidepressant responders (≥50% decrease in Montgomery-Åsberg Depression Rating Scale [MADRS] scores) received four further open-label infusions administered once-weekly. Changes in SI were assessed with the suicide items on the MADRS (item 10, MADRS-SI) and the Quick Inventory of Depressive Symptomatology-Self Report (item 12, QIDS-SI). Linear mixed models revealed that compared with midazolam, a single ketamine infusion elicited larger reduction in SI (P = 0.01), with maximal effects measured at 7 days postinfusion (P < 0.001, Cohen's d = 0.83). Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94). QIDS-SI results were consistent with MADRS-SI. Overall, 69% of participants had a complete alleviation of SI following repeated infusions. In TRD, single and repeated ketamine infusions resulted in decreases in SI which were maintained with once-weekly maintenance infusions. This study adds to the growing body of research suggesting ketamine as a possible novel treatment strategy for SI in mood disorders.",2020,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).",['Thirty-seven participants with treatment-resistant depression (TRD) and baseline SI first received a single'],"['midazolam', 'six open-label ketamine', 'ketamine', 'subanesthetic intravenous ketamine', 'ketamine infusion', 'ketamine infusions']","['Changes in SI', 'Quick Inventory of Depressive Symptomatology-Self Report', 'cumulative reductions in MADRS-SI scores', 'suicidal ideation (SI', 'SI', 'suicidal ideation', 'Montgomery-Åsberg Depression Rating Scale [MADRS] scores', 'complete alleviation of SI']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",37.0,0.234581,"Participants had cumulative reductions in MADRS-SI scores with repeated infusions (P < 0.001), and no further change with maintenance infusions (P = 0.94).","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Phillips', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada. Jennifer.Phillips@theroyal.ca.""}, {'ForeName': 'Sandhaya', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Talbot', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Hatchard', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Birmingham', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Olabisi', 'Initials': 'O', 'LastName': 'Owoeye', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Batten', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blier', 'Affiliation': ""Mood Disorders Research Unit, The Royal's Institute of Mental Health Research, Ottawa, ON, Canada.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0570-x']
392,32400903,Severe and enduring anorexia nervosa: No easy solutions.,"There is currently no evidence-based definition of severe and enduring anorexia nervosa (SE-AN) with which to reliably inform clinical practice and research. Indeed, data on the effect of AN severity and duration on treatment outcome are inconsistent. A large group of patients with SE-AN are repeatedly unsuccessfully managed with the available eating disorders treatments and have no access to adequate treatment for their illness. Cognitive behavioral therapy (CBT) adapted for SE-AN has been designed to enhance quality of life and reduce harm rather than promoting weight gain in such patients, and has had some success. However, a percentage of patients with SE-AN achieves remission, or at least returns to a normal weight range, with available evidence-based treatments for eating disorders, such as enhanced CBT (CBT-E). It would therefore be worth conducting a large-scale randomized controlled trial comparing CBT adapted for SE-AN with CBT-E to assess their relative acceptability; efficacy, including their effect on quality of life and medical stability; cost-effectiveness; and the treatment response moderators that might allow better matching of patients with SE-AN to a treatment oriented either to harm reduction or to change.",2020,"It would therefore be worth conducting a large-scale randomized controlled trial comparing CBT adapted for SE-AN with CBT-E to assess their relative acceptability; efficacy, including their effect on quality of life and medical stability; cost-effectiveness; and the treatment response moderators that might allow better matching of patients with SE-AN to a treatment oriented either to harm reduction or to change.",['Severe and enduring anorexia nervosa'],"['Cognitive behavioral therapy (CBT', 'CBT']",['quality of life and medical stability; cost-effectiveness'],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0280831,"It would therefore be worth conducting a large-scale randomized controlled trial comparing CBT adapted for SE-AN with CBT-E to assess their relative acceptability; efficacy, including their effect on quality of life and medical stability; cost-effectiveness; and the treatment response moderators that might allow better matching of patients with SE-AN to a treatment oriented either to harm reduction or to change.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Dalle Grave', 'Affiliation': 'Department of Eating and Weight Disorders, Villa Garda Hospital, Garda, Italy.'}]",The International journal of eating disorders,['10.1002/eat.23295']
393,32205067,Randomized Comparison of Optical Coherence Tomography Versus Angiography to Guide Bioresorbable Vascular Scaffold Implantation: The OPTICO BVS Study.,"PURPOSE
We investigated whether optical coherence tomography (OCT)-guided bioresorbable vascular scaffolds (BVS) implantation can improve in-scaffold minimal lumen area (MLA) at 6-month compared with angiography guidance.
METHODS
The OPTICO BVS was a randomized, international multicenter, assessor blind, superiority trial comparing OCT- versus angiography-guided percutaneous coronary intervention (PCI) (1:1 allocation) in patients with coronary artery disease undergoing Absorb BVS 1.1 implantation. The primary endpoint was in-scaffold MLA at 6-month.
RESULTS
The trial was prematurely stopped on May 31, 2017 after enrollment of 38 of 270 planned patients (14%) following the retraction of the device in Europe. Patients were randomly assigned to OCT- (n = 19) or angiography-guided PCI (n = 19). Scaffold diameter (OCT 3.0 ± 0.3 mm vs. angiography 3.1 ± 0.3 mm, P = .333) and length (28.8 ± 13.6 mm vs. 23.8 ± 12.3 mm, P = .223) were comparable. There was no significant difference in in-scaffold MLA at 6 months (4.47mm 2 vs. 5.08mm 2 , P = .692). Scaffold expansion at 6-month was significantly higher in the OCT-guided PCI as compared with angiography-guided PCI (84.5% vs. 76.5%, P = .010). There was no significant difference in clinical outcomes.
CONCLUSIONS
Although in-scaffold MLA at 6-month did not differ between groups, scaffold expansion was improved following OCT- as compared with angiography-guided PCI. The findings of this study must be interpreted in view of the premature termination with inclusion of 14% of the initially planned study sample.",2020,"Scaffold expansion at 6-month was significantly higher in the OCT-guided PCI as compared with angiography-guided PCI (84.5% vs. 76.5%, P = .010).","['2017 after enrollment of 38 of 270 planned patients (14%) following the retraction of the device in Europe', 'patients with coronary artery disease undergoing Absorb BVS 1.1 implantation']","['OCT- versus angiography-guided percutaneous coronary intervention (PCI', 'optical coherence tomography versus angiography to guide Bioresorbable vascular scaffold implantation', 'OCT', 'angiography-guided PCI', 'optical coherence tomography (OCT)-guided bioresorbable vascular scaffolds (BVS) implantation']","['Scaffold expansion', 'clinical outcomes', 'scaffold expansion', 'scaffold MLA']","[{'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0332523', 'cui_str': 'Retraction (finding)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.247205,"Scaffold expansion at 6-month was significantly higher in the OCT-guided PCI as compared with angiography-guided PCI (84.5% vs. 76.5%, P = .010).","[{'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ueki', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Yamaji', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular center Aalst, OLV clinic, Aalst, Belgium; Department of Advanced Biomedical Sciences, University of Naples Federico II, Italy.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Nef', 'Affiliation': 'Department of Cardiology, University of Giessen, Giessen, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Clinic Cardiovascular institute, University Hospital Clinic, IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), Barcelona, Spain.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Department of Cardiology, Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': ""Cardiac department, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, Fribourg University and Hospital, Fribourg, Switzerland.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Burzotta', 'Affiliation': 'Institute of Cardiology, Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Alexios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': 'Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Räber', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: lorenz.raeber@insel.ch.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.03.023']
394,32205070,Development of a community pharmacy-based intervention to enhance adherence to adjuvant endocrine therapy among breast cancer survivors guided by the Intervention Mapping approach.,"BACKGROUND
Adjuvant endocrine therapy (AET) is prescribed for 5 or 10 years to women with non-metastatic breast cancer to reduce recurrence and mortality risks. However, AET adherence is suboptimal for many women. The few interventions specifically designed to enhance AET adherence and evaluated to date have provided inconclusive results. None of these interventions was offered in the community pharmacy setting.
OBJECTIVE
To describe the development of the PAcHA program, a community pharmacy-based intervention aiming to enhance AET adherence.
METHODS
The development of the intervention was guided by the six-step Intervention Mapping approach: needs assessment (Step 1); development of objectives matrices (Step 2); selection of theory-based intervention methods and practical applications (Step 3); development of the intervention program (Step 4); development of the adoption and implementation plan (Step 5); and evaluation plan (Step 6). Researchers, pharmacists and women prescribed AET were consulted at key steps.
RESULTS
The logic model was developed based on women's needs identified through a literature review and a qualitative study (Step 1). Optimal use of treatment for each woman with a new AET prescription was considered the behavioral outcome of the intervention. A woman is expected to: acquire knowledge about AET; make an informed decision about AET initiation and persistence; respect administration modalities and cope with side effects (Step 2). Motivational interviewing principles serve to guide the pharmacist intervention (Step 3). The intervention is brief and tailored to AET initiation and follow-up visits. Standardized intervention tools are available as support for pharmacists in their counseling (Step 4). An implementation plan was established, and web-based training was designed to train the pharmacists (Step 5). A cluster-randomized controlled trial was designed to evaluate the intervention (Step 6).
CONCLUSION
The systematic approach used for developing the intervention may increase its potential for being efficiently implemented and effective.",2020,The development of the intervention was guided by the six-step Intervention Mapping approach: needs assessment (Step 1); development of objectives matrices (Step 2); selection of theory-based intervention methods and practical applications (Step 3); development of the intervention program (Step 4); development of the adoption and implementation plan (Step 5); and evaluation plan (Step 6).,"['5 or 10 years to women with non-metastatic breast cancer', 'breast cancer survivors']","['community pharmacy-based intervention', 'endocrine therapy', 'endocrine therapy (AET']",[],"[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0629582', 'cui_str': 'AETS'}]",[],,0.0316799,The development of the intervention was guided by the six-step Intervention Mapping approach: needs assessment (Step 1); development of objectives matrices (Step 2); selection of theory-based intervention methods and practical applications (Step 3); development of the intervention program (Step 4); development of the adoption and implementation plan (Step 5); and evaluation plan (Step 6).,"[{'ForeName': 'Mauranne', 'Initials': 'M', 'LastName': 'Labonté', 'Affiliation': 'Faculty of Pharmacy, Université Laval, Québec, QC, Canada; CHU de Québec-Université Laval Research Center, Population Health and Optimal Health Practices Axis, Québec, QC, Canada; CHU de Québec-Université Laval Research Center, Oncology Axis, Québec, QC, Canada; Équipe de Recherche Michel-Sarrazin en Oncologie Psychosociale et Soins Palliatifs (ERMOS), Québec, QC, Canada.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Guillaumie', 'Affiliation': 'CHU de Québec-Université Laval Research Center, Population Health and Optimal Health Practices Axis, Québec, QC, Canada; Faculty of Nursing, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dionne', 'Affiliation': 'Faculty of Pharmacy, Université Laval, Québec, QC, Canada; CHU de Québec-Université Laval Research Center, Oncology Axis, Québec, QC, Canada; Centre des Maladies du Sein, CHU de Québec-Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Dorval', 'Affiliation': 'Faculty of Pharmacy, Université Laval, Québec, QC, Canada; CHU de Québec-Université Laval Research Center, Oncology Axis, Québec, QC, Canada; Équipe de Recherche Michel-Sarrazin en Oncologie Psychosociale et Soins Palliatifs (ERMOS), Québec, QC, Canada; Centre des Maladies du Sein, CHU de Québec-Université Laval, Québec, QC, Canada; Centre intégré de santé et des services sociaux (CISSS) de Chaudière-Appalaches Research Center, Québec, QC, Canada.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Nabi', 'Affiliation': 'Faculty of Pharmacy, Université Laval, Québec, QC, Canada; CHU de Québec-Université Laval Research Center, Oncology Axis, Québec, QC, Canada; Équipe de Recherche Michel-Sarrazin en Oncologie Psychosociale et Soins Palliatifs (ERMOS), Québec, QC, Canada; Faculty of Medicine, Department of Social and Preventive Medicine, Université Laval, Québec, QC, Canada; Centre de recherche en épidémiologie et santé des populations, INSERM U. 1018, Villejuif, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lemieux', 'Affiliation': 'CHU de Québec-Université Laval Research Center, Oncology Axis, Québec, QC, Canada; Centre des Maladies du Sein, CHU de Québec-Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'CHU de Québec-Université Laval Research Center, Oncology Axis, Québec, QC, Canada; Centre des Maladies du Sein, CHU de Québec-Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lauzier', 'Affiliation': 'Faculty of Pharmacy, Université Laval, Québec, QC, Canada; CHU de Québec-Université Laval Research Center, Population Health and Optimal Health Practices Axis, Québec, QC, Canada; Équipe de Recherche Michel-Sarrazin en Oncologie Psychosociale et Soins Palliatifs (ERMOS), Québec, QC, Canada; Centre des Maladies du Sein, CHU de Québec-Université Laval, Québec, QC, Canada. Electronic address: sophie.lauzier@pha.ulaval.ca.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.02.004']
395,32401335,Breast shield design impacts milk removal dynamics during pumping: A randomized controlled non-inferiority trial.,"INTRODUCTION
While many studies have investigated the importance of optimizing pumping patterns for milk removal, the influence of breast shield design on milk removal has not been the focus of extensive investigation. This study aimed to determine the effectiveness of breast shields with either a 105° or a 90° flange opening angle on breast drainage and milk volume expressed during pumping.
MATERIAL AND METHODS
This study was a cross-over, randomized controlled non-inferiority trial (Registration; NCT03091985). Mothers (n = 49) of breastfeeding infants participated in the study over two study sessions. Participants were randomly assigned to pump both breasts simultaneously for 15 minutes with either the 105° or 90° breast shield in the first session, and the other shield in the second session. Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields were assessed after 15 minutes of pumping. Intention-to-treat and per protocol analyses were performed to determine if the 105° breast shield was non-inferior to the 90° breast shield for breast drainage and volume expressed. Perceived comfort was assessed via questionnaire.
RESULTS
The 105° breast shield was both non-inferior and superior compared to the standard 90° shield for breast drainage (intention-to-treat, 3.87% (0.01-7.72), P = .049) and volume expressed (intention-to-treat, 9.14 mL (1.37-16.91), P=.02). In addition, the 105° shield was rated as feeling more comfortable (P < .001) and as having an improved fit to the breast (P < .001) compared to the 90° shield.
CONCLUSIONS
Expressing with the 105° breast shield was more efficient, effective and comfortable compared to the 90° shield. Breast shield design can significantly impact pumping outcomes, and an opening angle of 105° improves both the dynamics and comfort of milk removal.",2020,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
",['Mothers (n=49) of breastfeeding infants participated in the study over two study sessions'],[],"['Effectiveness (breast drainage) and efficiency (volume expressed) of both breast shields', 'feeling more comfortable (p<.001) and as having an improved fit to the breast', 'Perceived comfort']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0222605', 'cui_str': 'Both breasts'}, {'cui': 'C0183251', 'cui_str': 'Shield'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0633338,"In addition, the 105° shield was rated as feeling more comfortable (p<.001) and as having an improved fit to the breast (p<.001) compared to the 90° shield.
","[{'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Sakalidis', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Ivarsson', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Alan G', 'Initials': 'AG', 'LastName': 'Haynes', 'Affiliation': 'Clinical Trials Unit (CTU) Bern, Faculty of Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Jäger', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Nania G', 'Initials': 'NG', 'LastName': 'Schärer-Hernández', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Leon R', 'Initials': 'LR', 'LastName': 'Mitoulas', 'Affiliation': 'Medela AG, Baar, Switzerland.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Prime', 'Affiliation': 'Medela AG, Baar, Switzerland.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13897']
396,32401339,Program of Active Consumer Engagement in Self-Management in Epilepsy: Replication and extension of a self-management randomized controlled trial.,"OBJECTIVE
The Program of Active Consumer Engagement in Self-Management in Epilepsy (PACES) is an evidenced-based self-management intervention for adults with epilepsy. Prior randomized controlled trial (RCT) data show that PACES reduces depression and improves self-management, self-efficacy, and quality of life for 6 months postprogram. The objective of this study was to replicate a PACES RCT with key extensions: more diverse patient pool from community-based epilepsy centers; option for telephone-based participation; and longer follow-up (12 months with booster support for intervention group), to examine duration of impact and inform dissemination and implementation.
METHODS
Participants were adults with chronic epilepsy (n = 101) without serious mental illness or substantive intellectual impairment, recruited from three epilepsy centers. Participants were randomly assigned to intervention or waitlist control groups. Outcomes included the Epilepsy Self-Management Scale (ESMS), Epilepsy Self-Efficacy Scale (ESES), Quality of Life in Epilepsy-31, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7, administered at baseline, postintervention (8 weeks), and 6 and 12 months postintervention. Intervention was an 8-week group of five to eight adults co-led by a psychologist and trained peer with epilepsy that met once per week by teleconference or in person at a hospital for 60-75 minutes. Topics included medical, psychosocial, cognitive, and self-management aspects of epilepsy, as well as community integration and epilepsy-related communication. Treatment group provided program evaluation.
RESULTS
PACES participants (n = 49) improved relative to controls (n = 52) on the ESES (P < .022) and overall distress composite (P = .008). At 6 months, PACES participants remained improved on the ESES (P = .008) and composite (P = .001), and were improved on the ESMS (P = .005). At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018). Attrition was low (<6% in each group), and all program satisfaction ratings exceeded 4.0/5.0.
SIGNIFICANCE
A consumer-generated epilepsy self-management program with broad psychosocial and medical emphasis can be effectively delivered by telephone or in person and facilitates long-term epilepsy self-management, adjustment, and coping up to 1 year after treatment.",2020,"At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018).","['Participants were adults with chronic epilepsy (n\xa0=\xa0101) without serious mental illness or substantive intellectual impairment, recruited from three epilepsy centers', 'Epilepsy', 'adults with epilepsy']","['PACES', 'adults co-led by a psychologist and trained peer with epilepsy that met once per week by teleconference or in person at a hospital for 60-75\xa0minutes']","['depression and improves self-management, self-efficacy, and quality of life', 'ESMS', 'overall distress composite of combined measures', 'Attrition', 'Epilepsy Self-Management Scale (ESMS), Epilepsy Self-Efficacy Scale (ESES), Quality of Life in Epilepsy-31, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7', 'overall distress composite', 'ESES']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]",101.0,0.0591539,"At 12 months, PACES participants remained improved on the ESMS (P = .006) and were improved on an overall distress composite of combined measures (P = .018).","[{'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Johnson', 'Affiliation': 'Health Promotion Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Fraser', 'Affiliation': 'Health Promotion Research Center, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lashley', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Barber', 'Affiliation': 'Department of Neurological Surgery, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Brandling-Bennett', 'Affiliation': 'UW Medicine, Valley Medical Center, Renton, Washington, USA.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Vossler', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Caylor', 'Affiliation': 'Swedish Neuroscience Institute, Seattle, Washington, USA.'}, {'ForeName': 'Tessala', 'Initials': 'T', 'LastName': 'Warheit-Niemi', 'Affiliation': 'Neurology Vocational Services Unit, University of Washington, Seattle, Washington, USA.'}]",Epilepsia,['10.1111/epi.16530']
397,32058185,Which pelvic floor muscle functions are associated with improved subjective and objective symptoms after 8 weeks of surface electrical stimulation in women with stress urinary incontinence?,"OBJECTIVE
Stress urinary incontinence (SUI) is defined as involuntary urine loss during effort, sneezing, or coughing. We investigated which pelvic floor muscle (PFM) functions (muscle strength, power, and endurance) are associated with improvement in subjective and objective symptoms after 8 weeks of surface electrical stimulation (SES) training. This study was performed to determine the effects of SES in the seated position on PFM functions and subjective and objective symptoms, and to identify predictors of improved subjective and objective symptoms after 8 weeks of SES training via secondary analysis of females with SUI.
STUDY DESIGN
The study was performed between August 2018 and December 2018. Patients with SUI were randomized into an SES group (n = 17) and a control group (n = 17). Both groups were assessed pre-intervention and after 8 weeks of intervention. The outcome measures were PFM functions (strength, power, and endurance) as measured via perineometry, the score on the urogenital distress inventory-6 (UDI-6), and the ultra-short perineal pad test result.
RESULTS
Significant differences in all PFM functions, the UDI-6 score, and the pad weight were evident both between the groups (SES vs. control group) and within the groups (pre-SES vs. post-SES). On regression of factors predicting relative changes in subjective and objective symptoms, the relative change in PFM power accounted for 15 and 13 % of the variance in the UDI-6 score (P < 0.05) and pad weight (P < 0.05), respectively.
CONCLUSIONS
SES in a seated position improved both subjective and objective symptoms in females with SUI. PFM power, the UDI-6 score, and the pad weight test result should be considered when developing intervention guidelines to improve the subjective and objective symptoms of females with SUI.",2020,"RESULTS
Significant differences in all PFM functions, the UDI-6 score, and the pad weight were evident both between the groups (SES vs. control group) and within the groups (pre-SES vs. post-SES).","['females with SUI', 'women with stress urinary incontinence', 'Patients with SUI', 'August 2018 and December 2018']","['SES training', 'SES', 'surface electrical stimulation (SES) training']","['PFM functions and subjective and objective symptoms', 'UDI-6 score', 'pad weight', 'PFM power, the UDI-6 score', 'PFM functions (strength, power, and endurance) as measured via perineometry, the score on the urogenital distress inventory-6 (UDI-6), and the ultra-short perineal pad test result', 'PFM functions, the UDI-6 score, and the pad weight', 'PFM power', 'subjective and objective symptoms', 'pelvic floor muscle (PFM) functions (muscle strength, power, and endurance']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0031066', 'cui_str': 'Perineum'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",,0.0194833,"RESULTS
Significant differences in all PFM functions, the UDI-6 score, and the pad weight were evident both between the groups (SES vs. control group) and within the groups (pre-SES vs. post-SES).","[{'ForeName': 'Ui-Jae', 'Initials': 'UJ', 'LastName': 'Hwang', 'Affiliation': '234 Maeji-ri, Heungeop-Myeon, Kangwon-Do 220-710, Department of Physical Therapy, Graduate School, Yonsei University, Wonju, South Korea. Electronic address: hwangu33@nate.com.'}, {'ForeName': 'Min-Seok', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': ""Sophie-Marceau Women's Clinic, Daegu, South Korea. Electronic address: msleesena@hanmail.net.""}, {'ForeName': 'Sung-Hoon', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': '234 Maeji-ri, Heungeop-Myeon, Kangwon-Do 220-710, Department of Physical Therapy, Graduate School, Yonsei University, Wonju, South Korea. Electronic address: movt_architect@daum.net.'}, {'ForeName': 'Sun-Hee', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': '234 Maeji-ri, Heungeop-Myeon, Kangwon-Do 220-710, Department of Physical Therapy, Graduate School, Yonsei University, Wonju, South Korea. Electronic address: tjsgml001@naver.com.'}, {'ForeName': 'Oh-Yun', 'Initials': 'OY', 'LastName': 'Kwon', 'Affiliation': '234 Maeji-ri, Heungeop-Myeon, Kangwon-Do 220-710, Department of Physical Therapy, College of Health Science, Laboratory of Kinetic Ergocise Based on Movement Analysis, Yonsei University, Wonju, South Korea. Electronic address: kwonoy@yonsei.ac.kr.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.02.008']
398,30685831,The Effects of Continuous Care Model of Information-Based Hospital-Family Integration on Colostomy Patients: a Randomized Controlled Trial.,"The purpose of this research was to examine the effects of continuous care model of information-based hospital-family integration on colostomy patients. Miles' operation is a major operative method for treating low rectal cancer, and this operation results in a permanent colostomy. It is difficult for patients to adapt to their colostomy. Previous studies have applied generally conventional nursing models to colostomy patients. This was a single-blind randomized controlled trial study. The sample of 155 patients who met the inclusion criteria was randomly assigned to either the experimental (n = 81) or control group (n = 74). The control group was provided with a routine standard of care. The experimental group was provided with an experimental treatment that consisted of an information-based (WeChat, blog, QQ, telephone, etc.) hospital-family integration continuous care model. Study variables were collected and instruments were selected as follows: basic information, State-Trait Anxiety Inventory (STAI), a self-efficacy scale, a colostomy complication assessment table, a quality of life scale, and a table of the degree of satisfaction. No statistically significant differences were found in demographic information between the experimental and control groups. In comparison with the control group, subjects in the experimental group had less anxiety and could better cope with anxiety, had a better self-efficacy and quality of life scores, and had fewer complications. The patients in the experimental group were shown to be more satisfied with the care model. In addition, the most useful and popular service is the online social tools WeChat and QQ, because they can communicate with video, and they are more real-time, efficient, and cheap. The continuous care model of information-based hospital-family integration significantly strengthened patients' self-efficacy and confidence, which decreased colostomy complications, ultimately improving the quality of life.",2020,"In comparison with the control group, subjects in the experimental group had less anxiety and could better cope with anxiety, had a better self-efficacy and quality of life scores, and had fewer complications.","['155 patients who met the inclusion criteria', 'colostomy patients', 'Colostomy Patients']","['continuous care model of information-based hospital-family integration', 'information-based (WeChat, blog, QQ, telephone, etc.) hospital-family integration continuous care model', 'Continuous Care Model of Information-Based Hospital-Family Integration']","['self-efficacy and quality of life scores', 'anxiety', 'quality of life', 'demographic information', 'basic information, State-Trait Anxiety Inventory (STAI), a self-efficacy scale, a colostomy complication assessment table, a quality of life scale, and a table of the degree of satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2718046', 'cui_str': 'Blog'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1706074', 'cui_str': 'Table'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",155.0,0.045355,"In comparison with the control group, subjects in the experimental group had less anxiety and could better cope with anxiety, had a better self-efficacy and quality of life scores, and had fewer complications.","[{'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Colorectal and Anal Surgery, The First Affiliated Hospital of Wenzhou Medical University, New Hospital Area, Nanbaixiang Street, Ouhai District, Wenzhou, 325000, Zhejiang, China. LiminXia890er@163.com.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1465-y']
399,32200533,Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood: A Randomized Exploratory Study of the Effect of Omega-3 Fatty Acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia.,"INTRODUCTION
Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation (Lotriga ® , Takeda Pharmaceutical Company Limited), are approved in Japan to treat triglyceridemia. We investigated the effects of omega-3 on vascular endothelial function, measured by flow-mediated dilation (FMD).
METHODS
Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors were randomized 1:1 to receive omega-3 at 2 g (QD) or 4 g (2 g BID) for 8 weeks. The primary end point was the change from baseline of fasting %FMD in each treatment group. Secondary end points included the 4-h postprandial %FMD and 4-h postprandial triglyceride (TG) level.
RESULTS
Thirty-seven patients were randomized to receive omega-3 at 2 g (n = 18) or 4 g (n = 19). Mean fasting %FMD did not increase from baseline to week 8 in the 2-g group (- 1.2%) or 4-g group (- 1.3%). Mean 4-h postprandial %FMD did not change from baseline to week 8 in the 2-g group (0.0%), but increased in the 4-g group (1.0%). Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001). No new safety concerns were identified.
CONCLUSIONS
Fasting %FMD did not improve after 8 weeks of omega-3 treatment at 2 g or 4 g. After 8 weeks, 4-h postprandial TG levels showed improvement at both doses, with a greater reduction in the 4-g group.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT02824432.",2020,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","['Patients With Hyperlipidemia', 'Thirty-seven patients', 'Patients with dyslipidemia receiving 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors']","['Omega-3 Fatty Acid Ethyl Esters', 'Omega-3 fatty acid ethyl esters (omega-3), an eicosapentaenoic acid and docosahexaenoic acid preparation', 'omega-3 at 2\xa0g']","['Mean 4-h postprandial TG level', '4-h postprandial \xa0%FMD and 4-h postprandial triglyceride (TG) level', 'Vascular Endothelial Function', 'Mean 4-h postprandial %FMD', 'change from baseline of fasting \xa0%FMD', 'Discrepancy Between Fasting Flow-Mediated Dilation and Parameter of Lipids in Blood', '4-h postprandial TG levels', 'Mean fasting %FMD', 'vascular endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0061511', 'cui_str': 'glutaryl-coenzyme A'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C3884644', 'cui_str': '(trimethylsilyl)ethyl ester'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}]",37.0,0.0642346,"Mean 4-h postprandial TG level decreased by 34.7 mg/dl from baseline over week 8 in the 2-g group, with a significantly larger decrease in the 4-g group of 75.9 mg/dl (p < 0.001).","[{'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Teramoto', 'Affiliation': 'Teikyo Academic Research Center, Teikyo University, Tokyo, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Shibata', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suzaki', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan. yuki.suzaki@takeda.com.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Uemura', 'Affiliation': 'Faculty of Medicine, Oita University, Oita, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University, Tokyo, Japan.'}]",Advances in therapy,['10.1007/s12325-020-01286-1']
400,31303479,Patients beliefs and attitudes towards deprescribing: Can deprescribing success be predicted?,"BACKGROUND
The ability of questionnaires such as the Patients' Attitudes Towards Deprescribing (PATD) or the Beliefs about Medicines Questionnaire (Specific section) (BMQ-Specific) to successfully identify patients who will deprescribe remains unknown.
OBJECTIVE
To determine if screening questionnaires assessing patients' attitudes and beliefs towards medications and deprescribing can predict deprescribing outcomes.
METHODS
This is a post-hoc secondary analysis of the D-PRESCRIBE trial. 489 community-dwelling adults (≥65 years) who were chronic users (≥3 months) of a potentially inappropriate medication were randomized to a pharmacist-led educational intervention or usual care. Association between baseline responses to PATD and BMQ-Specific items and successful deprescribing was calculated. To determine predictive ability of questionnaire items, receiver operating characteristic curves (ROC) were constructed and area under the curve was calculated.
RESULTS
At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed. Six items were associated with deprescribing success, however, no PATD or BMQ-Specific item - either independently or in combination - meaningfully distinguished which participants succeeded or failed deprescribing attempts at 6-months (AUC < 0.7).
CONCLUSION
Current tools to assess patient's attitudes and beliefs towards medication use and/or deprescribing have low predictive validity for successful deprescribing.",2020,"At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed.","['489 community-dwelling adults (≥65 years) who were chronic users (≥3 months) of a potentially inappropriate medication', ""Patients' Attitudes""]",['pharmacist-led educational intervention or usual care'],[],"[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],489.0,0.109975,"At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed.","[{'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Turner', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada. Electronic address: justin.turner@criugm.qc.ca.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Yi Zhi', 'Initials': 'YZ', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Tannenbaum', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada; Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.07.007']
401,31834252,Effects of Exercise Training and Statin Use in People Living with Human Immunodeficiency Virus with Dyslipidemia.,"PURPOSE
To evaluate the effects of the combination of exercise training (ET) and statins in people living with human immunodeficiency virus.
METHODS
This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with human immunodeficiency virus were assigned to either placebo (PL), statins (STA), PL + ET (PLET) or STA + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. The PLET and STAET groups performed ET three times a week. Before and after the 12-wk follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS
There was a decrease in total cholesterol, triglycerides, low-density lipoprotein, C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness in the STA, PLET, and STAET groups compared with PL group (P < 0.001). Furthermore, there was a decrease in total cholesterol, triglycerides, low-density lipoprotein, IL-1β, IL-6, and IL-8 levels and in left and right carotid intima-media thickness and an increase in HDL-c levels in the STAET groups compared with the STA (P ≤ 0.001) and PLET groups (P ≤ 0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared with the PL (P ≤ 0.001) and STA groups (P ≤ 0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared with PL (P ≤ 0.001) and STA (P ≤ 0.001) groups.
CONCLUSIONS
The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce cardiovascular disease markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2020,"There was a decrease in total cholesterol, triglycerides, low-density lipoprotein, C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness in the STA, PLET, and STAET groups compared with PL group (P < 0.001).","['People Living with Human Immunodeficiency Virus with Dyslipidemia', 'people living with human immunodeficiency virus', 'people living with HIV', 'Eighty-three people living with human immunodeficiency virus']","['STA', 'placebo', 'exercise training (ET) and statins', 'rosuvastatin', 'placebo (PL), statins (STA), PL + ET (PLET) or STA + ET (STAET', 'Exercise Training and Statin Use']","['IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'total cholesterol, triglycerides, low-density lipoprotein, C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness', 'total cholesterol, triglycerides, low-density lipoprotein, IL-1β, IL-6, and IL-8 levels and in left and right carotid intima-media thickness', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'HDL-c levels', 'body fat mass, body fat percentage and increased lean body mass, MS and CF']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}]",83.0,0.140864,"There was a decrease in total cholesterol, triglycerides, low-density lipoprotein, C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness in the STA, PLET, and STAET groups compared with PL group (P < 0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, BRAZIL.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, BRAZIL.'}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Teixeira Paranhos Lopes', 'Affiliation': 'Department of Medicine, Brazil University, Fernandópolis/SP, BRAZIL.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, BRAZIL.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, BRAZIL.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, BRAZIL.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, BRAZIL.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, BRAZIL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
402,31548678,Brain regulation of emotional conflict predicts antidepressant treatment response for depression.,"The efficacy of antidepressant treatment for depression is controversial due to the only modest superiority demonstrated over placebo. However, neurobiological heterogeneity within depression may limit overall antidepressant efficacy. We sought to identify a neurobiological phenotype responsive to antidepressant treatment by testing pretreatment brain activation during response to, and regulation of, emotional conflict as a moderator of the clinical benefit of the antidepressant sertraline versus placebo. Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes. Treatment-predictive machine learning using brain metrics outperformed a model trained on clinical and demographic variables. Our findings demonstrate that antidepressant response is predicted by brain activity underlying a key self-regulatory emotional capacity. Leveraging brain-based measures in psychiatry will forge a path toward better treatment personalization, refined mechanistic insights and improved outcomes.",2019,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.",[],['placebo'],[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0530251,"Using neuroimaging data from a large randomized controlled trial, we found widespread moderation of clinical benefits by brain activity during regulation of emotional conflict, in which greater downregulation of conflict-responsive regions predicted better sertraline outcomes.","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA. amitetkin@stanford.edu.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Trombello', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Myrna M', 'Initials': 'MM', 'LastName': 'Weissman', 'Affiliation': 'New York State Psychiatric Institute and Department of Psychiatry, College of Physicians and Surgeons of Columbia University, New York, NY, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]",Nature human behaviour,['10.1038/s41562-019-0732-1']
403,32187469,Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months.,"BACKGROUND
The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Data are needed on whether diskectomy or a conservative approach is better for sciatica that has persisted for several months.
METHODS
In a single-center trial, we randomly assigned patients with sciatica that had lasted for 4 to 12 months and lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed. Surgery was performed by spine surgeons who used conventional microdiskectomy techniques. The primary outcome was the intensity of leg pain on a visual analogue scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment. Secondary outcomes were the score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year.
RESULTS
From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group. Among the patients assigned to undergo surgery, the median time from randomization to surgery was 3.1 weeks; of the 64 patients in the nonsurgical group, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment. At baseline, the mean score for leg-pain intensity was 7.7 in the surgical group and 8.0 in the nonsurgical group. The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001). Secondary outcomes including the score on the Owestry Disability Index and pain at 12 months were in the same direction as the primary outcome. Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation.
CONCLUSIONS
In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up. (Funded by Physicians' Services Incorporated Foundation; ClinicalTrials.gov number, NCT01335646.).",2020,"The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001).","['From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group']",['lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed'],"['adverse events', 'mean score for leg-pain intensity', 'severe pain', 'leg-pain intensity score', 'pain intensity', 'score on the Owestry Disability Index and pain', 'intensity of leg pain on a visual analogue scale', 'score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0034380'}]",790.0,0.147,"The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001).","[{'ForeName': 'Chris S', 'Initials': 'CS', 'LastName': 'Bailey', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Rasoulinejad', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Sequeira', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rosedale', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Stewart I', 'Initials': 'SI', 'LastName': 'Bailey', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Gurr', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Fawaz', 'Initials': 'F', 'LastName': 'Siddiqi', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Glennie', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Urquhart', 'Affiliation': ""From the Department of Surgery (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G., J.C.U.) and Occupational Health and Safety (R.R.), London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University (C.S.B., P.R., D.T., S.I.B., K.R.G., F.S., A.G.), Lawson Health Research Institute (C.S.B., P.R., J.C.U.), Regional Rehabilitation and Spinal Cord Injury Outpatients, Parkwood Institute (K.S.), and the Departments of Physical Medicine and Rehabilitation (T.M.) and Anesthesia and Perioperative Medicine (J.W.), St. Joseph's Hospital - all in London, ON, Canada.""}]",The New England journal of medicine,['10.1056/NEJMoa1912658']
404,31962344,Activation of D1 receptors affects human reactivity and flexibility to valued cues.,"Reward-predicting cues motivate goal-directed behavior, but in unstable environments humans must also be able to flexibly update cue-reward associations. While the capacity of reward cues to trigger motivation ('reactivity') as well as flexibility in cue-reward associations have been linked to the neurotransmitter dopamine in humans, the specific contribution of the dopamine D1 receptor family to these behaviors remained elusive. To fill this gap, we conducted a randomized, placebo-controlled, double-blind pharmacological study testing the impact of three different doses of a novel D1 agonist (relative to placebo) on reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning). We observed that the impact of the D1 agonist crucially depended on baseline working memory functioning, which has been identified as a proxy for baseline dopamine synthesis capacity. Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity. In contrast, higher doses of the D1 agonist improved reversal learning only in individuals with low baseline working memory functioning. Our findings suggest a crucial and baseline-dependent role of D1 receptor activation in controlling both cue reactivity and the flexibility of cue-reward associations.",2020,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.",[],"['novel D1 agonist (relative to placebo', 'placebo']","['reactivity to reward-predicting cues (Pavlovian-to-instrumental transfer) and flexibility of cue-outcome associations (reversal learning', 'reversal learning']",[],"[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",,0.119234,"Specifically, increasing D1 receptor stimulation strengthened Pavlovian-to-instrumental transfer in individuals with high baseline working memory capacity.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Soutschek', 'Affiliation': 'Department of Psychology, Ludwig Maximilian University Munich, Munich, Germany. Alexander.Soutschek@psy.lmu.de.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Takeda Pharmaceuticals International, Cambridge, MA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'de Martinis', 'Affiliation': 'Praxis Precision Medicines, Cambridge, MA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Howe', 'Affiliation': 'School of Neuroscience, Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Burke', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ernst', 'Initials': 'E', 'LastName': 'Fehr', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Jetter', 'Affiliation': 'Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Philippe N', 'Initials': 'PN', 'LastName': 'Tobler', 'Affiliation': 'Zurich Center for Neuroeconomics, Department of Economics, University of Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0617-z']
405,32195768,Casein Ingestion Does Not Increase Muscle Connective Tissue Protein Synthesis Rates.,"PURPOSE
This study aimed to assess the effect of dietary protein ingestion on intramuscular connective tissue protein synthesis rates during overnight recovery from a single bout of resistance exercise.
METHODS
Thirty-six healthy, young males were randomly assigned to one of three treatments. One group ingested 30 g intrinsically L-[1-C]-phenylalanine-labeled casein protein before sleep (PRO, n = 12). The other two groups performed a bout of resistance exercise in the evening and ingested either placebo (EX, n = 12) or 30 g intrinsically L-[1-C]-phenylalanine-labeled casein protein before sleep (EX + PRO, n = 12). Continuous intravenous infusions of L-[ring-H5]-phenylalanine and L-[1-C]-leucine were applied, and blood and muscle tissue samples were collected to assess connective tissue protein synthesis rates and dietary protein-derived amino acid incorporation in the connective tissue protein fraction.
RESULTS
Resistance exercise resulted in higher connective tissue protein synthesis rates when compared with rest (0.086 ± 0.017%·h [EX] and 0.080 ± 0.019%·h [EX + PRO] vs 0.059 ± 0.016%·h [PRO]; P < 0.05). Postexercise casein protein ingestion did not result in higher connective tissue protein synthesis rates when compared with postexercise placebo ingestion (P = 1.00). Dietary protein-derived amino acids were incorporated into the connective tissue protein fraction at rest, and to a greater extent during recovery from exercise (P = 0.002).
CONCLUSION
Resistance exercise increases intramuscular connective tissue protein synthesis rates during overnight sleep, with no further effect of postexercise protein ingestion. However, dietary protein-derived amino acids are being used as precursors to support de novo connective tissue protein synthesis.",2020,Post-exercise casein protein ingestion did not result in higher connective tissue protein synthesis rates when compared to post-exercise placebo ingestion (P=1.00).,"['Thirty-six healthy, young males']","['Resistance exercise', 'bout of resistance exercise', 'placebo (EX, n=12) or 30 g intrinsically L-[1-C]-phenylalanine-labeled casein protein', 'dietary protein ingestion', 'Dietary protein-derived amino acids', 'L-[1-C]-phenylalanine-labeled casein protein', 'L-[ring-H5]-phenylalanine and L-[1-C]-leucine', 'Casein Ingestion']","['higher connective tissue protein synthesis rates', 'connective tissue protein synthesis rates']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0301698', 'cui_str': 'Connective tissue protein (substance)'}]",36.0,0.0150714,Post-exercise casein protein ingestion did not result in higher connective tissue protein synthesis rates when compared to post-exercise placebo ingestion (P=1.00).,"[{'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Trommelen', 'Affiliation': '1NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Maastricht, THE NETHERLANDS 2Top Institute Food and Nutrition (TIFN), Wageningen, THE NETHERLANDS.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Holwerda', 'Affiliation': ''}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Senden', 'Affiliation': ''}, {'ForeName': 'Joy P B', 'Initials': 'JPB', 'LastName': 'Goessens', 'Affiliation': ''}, {'ForeName': 'Janneau', 'Initials': 'J', 'LastName': 'VAN Kranenburg', 'Affiliation': ''}, {'ForeName': 'Annemie P', 'Initials': 'AP', 'LastName': 'Gijsen', 'Affiliation': ''}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': ''}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'VAN Loon', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002337']
406,31994303,Comparison of the effects of oral iron treatment every day and every other day in female patients with iron deficiency anaemia.,"BACKGROUND
It is known that daily divided doses and high doses of iron increase hepcidin and reduce iron absorption.
AIM
This study aimed to compare treatments of iron replacement every other day at low doses, once a day and twice a day in terms of their effectiveness and frequencies of side effects.
METHODS
For a month, Group I received 270 mg ferrous sulphate twice a day (total elemental iron dose: 160 mg/day), Group II received 270 mg ferrous sulphate once a day (total elemental iron dose: 80 mg/day), and Group III received 270 mg ferrous sulphate every other day (total elemental iron dose: 80 mg/every other day). Intragroup and intergroup statistical analyses were carried out.
RESULTS
Haemoglobin (Hb) increased significantly in all three groups (P = 0.00). The increase in Hb levels was similar among the groups (P = 0.09). Ferritin significantly increased in all three groups after the treatment (P = 0.00). The increase in ferritin in Group I was significantly higher than those in Groups II and III (P < 0.05). Gastrointestinal tract (GIS) side effects were also significantly higher in Group I in comparison to the others (P = 0.001).
CONCLUSIONS
A low-dosage of iron treatment every other day may be used in the place of providing iron once or twice every day with similar effectiveness and lower rates of GIS side effects.",2020,"GIS side effects were also significantly higher in Group I in comparison to the others (p: 0.001).
",['Female Patients with Iron Deficiency Anemia'],"['Oral Iron Treatment', 'ferrous sulfate']","['Hemoglobin (Hb', 'Ferritin', 'Hb levels', 'increase in ferritin', 'GIS side effects']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0205757,"GIS side effects were also significantly higher in Group I in comparison to the others (p: 0.001).
","[{'ForeName': 'Nur', 'Initials': 'N', 'LastName': 'Düzen Oflas', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Demircioğlu', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Narin', 'Initials': 'N', 'LastName': 'Yıldırım Doğan', 'Affiliation': 'Department of Internal Medicine, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Elife', 'Initials': 'E', 'LastName': 'Eker', 'Affiliation': 'Department of Internal Medicine, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kutlucan', 'Affiliation': 'Department of Hematology, Van Training and Research Hospital, Van, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Doğan', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aslan', 'Affiliation': 'Faculty of Medicine, Department of Internal Medicine, Van Yüzüncü Yıl University, Van, Turkey.'}, {'ForeName': 'Cengiz', 'Initials': 'C', 'LastName': 'Demir', 'Affiliation': 'Faculty of Medicine, Department of Hematology, Van Yüzüncü Yıl University, Van, Turkey.'}]",Internal medicine journal,['10.1111/imj.14766']
407,31995811,Nicotine dependence (trait) and acute nicotinic stimulation (state) modulate attention but not inhibitory control: converging fMRI evidence from Go-Nogo and Flanker tasks.,"Cognitive deficits during nicotine withdrawal may contribute to smoking relapse. However, interacting effects of chronic nicotine dependence and acute nicotine withdrawal on cognitive control are poorly understood. Here we examine the effects of nicotine dependence (trait; smokers (n = 24) vs. non-smoking controls; n = 20) and acute nicotinic stimulation (state; administration of nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning. We compared performance and neural responses between these four pharmacological manipulations in a double-blind, placebo-controlled crossover design. As expected, performance in both tasks was modulated by nicotine dependence, abstinence, and pharmacological manipulation. However, effects were driven entirely by conditions that required less inhibitory control. When demand for inhibitory control was high, abstinent smokers showed no deficits. By contrast, acutely abstinent smokers showed performance deficits in easier conditions and missed more trials. Go-Nogo fMRI results showed decreased inhibition-related neural activity in right anterior insula and right putamen in smokers and decreased dorsal anterior cingulate cortex activity on nicotine across groups. No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task. Given robust nicotinic effects on physiology and behavioral deficits in attention, we are confident that pharmacological manipulations were effective. Thus findings fit a recent proposal that abstinent smokers show decreased ability to divert cognitive resources at low or intermediate cognitive demand, while performance at high cognitive demand remains relatively unaffected, suggesting a primary attentional deficit during acute abstinence.",2020,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,['trait; smokers (n\u2009=\u200924) vs. non-smoking controls; n\u2009=\u200920) and acute nicotinic stimulation (state; administration of'],"['nicotine and varenicline, two FDA-approved smoking cessation aids, during abstinence), on two well-established tests of inhibitory control, the Go-Nogo task and the Flanker task, during fMRI scanning', 'nicotine dependence', 'placebo', 'Nicotine dependence (trait) and acute nicotinic stimulation (state']","['dorsal anterior cingulate cortex activity', 'inhibition-related neural activity', 'performance deficits', 'Cognitive deficits', 'inhibition-related activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]",,0.0240423,No effects were found on inhibition-related activity during the Flanker task or on error-related activity in either task.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lesage', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Sutherland', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Ross', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Salmeron', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Stein', 'Affiliation': 'Neuroimaging Research Branch, National Institute on Drug Abuse, Intramural Research Program, National Institutes of Health, Baltimore, MD, USA. Estein@nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0623-1']
408,31470240,"Piloting a clinical laboratory method to evaluate the influence of potential modified risk tobacco products on smokers' quit-related motivation, choice, and behavior.","Research methods are needed that can predict whether the availability of potential modified risk tobacco products (MRTPs) may influence smokers' quit-related motivation, choice, and behavior. This pilot study assessed the primary outcomes of feasibility and adherence to address this need using an electronic cigarette (ECIG) as a model MRTP. Cigarette smokers were randomly assigned to use only their own brand of cigarettes (OB-only) or a second-generation ECIG (18 ng/ml nicotine) plus their OB cigarettes (ECIG+OB) ad libitum for four weeks. Participants logged products using a mobile device, collected used cigarette filters, and provided saliva samples every day for analysis of cotinine. They returned to the lab once per week to provide a breath sample and accept or decline a choice to quit all tobacco products (i.e., cigarettes and/or ECIGs). They also returned for a one-month follow-up visit. Of those participants randomized (n = 60), 56.7% completed the 4-week intervention and 40.0% completed the follow-up visit. The primary reason for withdrawal was poor adherence with mobile device use. Comparable numbers of participants in each group chose to make a quit attempt, although more OB-only participants chose to quit during the first two weeks and more ECIG+OB participants during the last two weeks. With protocol modifications to reduce participation burden, the current method might ultimately be used by regulators to predict how smokers' quit-related motivation, choice, and behavior are influenced by current and future MRTPs.",2019,"Comparable numbers of participants in each group chose to make a quit attempt, although more OB-only participants chose to quit during the first two weeks and more ECIG+OB participants during the last two weeks.",['Cigarette smokers'],"['electronic cigarette (ECIG', 'cigarettes (OB-only) or a second-generation ECIG (18\u202fng/ml nicotine) plus their OB cigarettes (ECIG+OB) ad libitum']","[""smokers' quit-related motivation, choice, and behavior""]","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0640915,"Comparable numbers of participants in each group chose to make a quit attempt, although more OB-only participants chose to quit during the first two weeks and more ECIG+OB participants during the last two weeks.","[{'ForeName': 'Jenny E', 'Initials': 'JE', 'LastName': 'Ozga-Hess', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Felicione', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'School of Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Geri', 'Initials': 'G', 'LastName': 'Dino', 'Affiliation': 'WV Prevention Research Center, West Virginia University, Morgantown, WV, USA; Department of Social and Behavioral Sciences, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Elswick', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Whitworth', 'Affiliation': 'WV Prevention Research Center, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Turiano', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Blank', 'Affiliation': 'Department of Psychology, West Virginia University, Morgantown, WV, USA. Electronic address: Melissa.Blank@mail.wvu.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106105']
409,31797417,"Effect of Aerobic or Resistance Exercise, or Both, on Bone Mineral Density and Bone Metabolism in Obese Older Adults While Dieting: A Randomized Controlled Trial.","Weight loss therapy of older adults with obesity is limited by weight loss-induced decrease in bone mineral density (BMD), which could exacerbate ongoing age-related bone loss and increase the risk for fractures. Therefore, it is recommended that weight loss therapy of older adults with obesity should include an intervention such as regular exercise to reduce the concomitant bone loss. However, the most appropriate exercise types to combine with weight loss therapy in this older population is unknown. In a randomized controlled trial, we performed a head-to-head comparison of aerobic or resistance exercise, or both, during matched ~10% weight loss in 160 older adults with obesity. We measured changes in BMD (total hip, femoral neck, trochanter, intertrochanter, one-third radius, lumbar spine) and bone markers. Changes between groups were analyzed using mixed-model repeated measures analyses of variance. After 6 months of intensive lifestyle interventions, BMD decreased less in the resistance group (-0.006 g/cm 2 [-0.7%]) and combination group (-0.012 g/cm 2 [-1.1%]) than in the aerobic group (-0.027 g/cm 2 [-2.6%]) (p = 0.001 for between-group comparisons). Serum C-telopeptide, procollagen type 1 N-propeptide, and osteocalcin concentrations increased more in the aerobic group (33%, 16%, and 16%, respectively) than in the resistance group (7%, 2%, and 0%, respectively) and combination group (11%, 2%, and 5%, respectively) (p = 0.004 to 0.048 for between-group comparisons). Multiple regression analyses revealed that the decline in whole body mass and serum leptin were the independent predictors of the decline in hip BMD (multiple R = 0.45 [p < .001]). These findings indicate that compared with aerobic exercise, resistance and combined aerobic and resistance exercise are associated with less weight loss-induced decrease in hip BMD and less weight loss-induced increase in bone turnover. Therefore, both resistance and combined aerobic and resistance exercise can be recommended to protect against bone loss during weight loss therapy of older adults with obesity. (LITOE ClinicalTrials.gov number NCT01065636.) © 2019 American Society for Bone and Mineral Research. Published 2019. This article is a U.S. Government work and is in the public domain in the USA.",2020,"osteocalcin concentrations increased more in the aerobic group (33%, 16%, and 16%, respectively) than in the resistance group (7%, 2%, and 0%, respectively) and combination group (11%, 2%, and 5%, respectively) (p = 0.004 to 0.048 for between-group comparisons).","['160 older adults with obesity', '© 2019 American Society for Bone and Mineral Research', 'Obese Older Adults', 'older adults with obesity']","['aerobic or resistance exercise', 'Aerobic or Resistance Exercise', 'Weight loss therapy', 'combined aerobic and resistance exercise']","['bone turnover', 'osteocalcin concentrations', 'Serum C-telopeptide, procollagen type 1\u2009N-propeptide, and', 'hip BMD', 'bone mineral density (BMD', 'whole body mass and serum leptin', 'weight loss', 'BMD (total hip, femoral neck, trochanter, intertrochanter, one-third radius, lumbar spine) and bone markers', 'Bone Mineral Density and Bone Metabolism']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0035168'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0162370', 'cui_str': 'Trochanter'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",160.0,0.0498452,"osteocalcin concentrations increased more in the aerobic group (33%, 16%, and 16%, respectively) than in the resistance group (7%, 2%, and 0%, respectively) and combination group (11%, 2%, and 5%, respectively) (p = 0.004 to 0.048 for between-group comparisons).","[{'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Aguirre', 'Affiliation': 'Medicine Care Line, New Mexico VA Health Care System, Albuquerque, NM, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Waters', 'Affiliation': 'Department of Internal Medicine, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Napoli', 'Affiliation': 'Division of Bone and Mineral Diseases, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Department of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM, USA.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Baylor College of Medicine, Houston, TX, USA.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3905']
410,31932751,"Comment on ""The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial"".",,2020,,['breast cancer diagnosis'],[],[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",[],[],,0.0644401,,"[{'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Bail', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB), Webb 601, 1675 University Boulevard, Birmingham, AL, 35294-3300, USA. jbail@uab.edu.'}, {'ForeName': 'Karina I', 'Initials': 'KI', 'LastName': 'Halilova', 'Affiliation': 'Division of Preventive Medicine, UAB, Birmingham, AL, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Demark-Wahnefried', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham (UAB), Webb 601, 1675 University Boulevard, Birmingham, AL, 35294-3300, USA.'}, {'ForeName': 'Marina M', 'Initials': 'MM', 'LastName': 'Reeves', 'Affiliation': 'School of Public Health, The University of Queensland, Herston, QLD, Australia.'}]",British journal of cancer,['10.1038/s41416-019-0714-0']
411,31932752,"Reply to Comment on ""The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial"".",,2020,,['breast cancer diagnosis'],['home versus community-based weight control programmes'],[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}]",[],,0.0522995,,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Harvie', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK. michelle.harvie@manchester.ac.uk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pegington', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bundred', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Applied Sciences, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Belcher', 'Affiliation': 'Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}]",British journal of cancer,['10.1038/s41416-019-0715-z']
412,31785588,Increased subjective and reinforcing effects of initial nicotine exposure in young adults with attention deficit hyperactivity disorder (ADHD) compared to matched peers: results from an experimental model of first-time tobacco use.,"Individuals with attention deficit hyperactivity disorder (ADHD) are at increased risk for adverse cigarette smoking outcomes, and little is known about factors underlying this risk. This study sought to evaluate the effects of initial nicotine exposure in young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences. Participants were young adult nonsmokers (n = 61 ADHD, n = 75 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years. Participants were exposed to three different blinded doses of intranasally administered nicotine (0, 0.5, 1.0 mg) across three separate fixed dose experimental sessions. In subsequent sessions, participants were given the opportunity to self-administer nicotine under two different conditions-high and low cognitive demand. Physiological, subjective, and reinforcing effects of nicotine were the main outcomes. Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups. ADHD participants reported significantly greater dizziness following nicotine, and greater pleasant subjective effects across all conditions, compared to non-ADHD non-smokers. There were no group differences on subjective reports of bad or unpleasant effects. Subsequent nicotine self-administration was significantly higher among non-smokers with ADHD, and their choices of nicotine were not influenced by cognitive condition. There are meaningful differences between young adults with and without ADHD with respect to the initial subjective and reinforcing effects of nicotine; and interventions to prevent use should start prior to typical age of experimentation among ADHD patients.",2020,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","['young adults with attention deficit hyperactivity disorder (ADHD', 'Participants were young adult nonsmokers (n\u2009=\u200961 ADHD, n\u2009=\u200975 Control) between the ages of 18-25 years (inclusive) who reported never having smoked a full cigarette, and no tobacco use in the prior 3 years', 'Individuals with attention deficit hyperactivity disorder (ADHD', 'young adults with and without ADHD using a novel paradigm of exposure to model initial smoking experiences']","['initial nicotine exposure', 'nicotine']","['Nicotine plasma levels', 'subjective reports of bad or unpleasant effects', 'pleasant subjective effects', 'dizziness', 'heart rate or blood pressure']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0040335', 'cui_str': 'Tobacco use'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",61.0,0.016876,"Nicotine plasma levels, and no group differences in effects of nicotine on heart rate or blood pressure, confirmed comparable dosing exposure across groups.","[{'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Kollins', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA. scott.kollins@duke.edu.'}, {'ForeName': 'Maggie M', 'Initials': 'MM', 'LastName': 'Sweitzer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'F Joseph', 'Initials': 'FJ', 'LastName': 'McClernon', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Perkins', 'Affiliation': 'Departments of Psychiatry, Psychology, and Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0581-7']
413,32185634,Clinical evaluation of instrumentation time and quality of obturation using paediatric hand and rotary file systems with conventional hand K-files for pulpectomy in primary mandibular molars: a double-blinded randomized controlled trial.,"AIM
The present study aims to comparatively evaluate the instrumentation time and obturation quality using paediatric manual (Kedo-SH) and rotary (Kedo-S and Kedo-SG Blue) with conventional manual (Hand K-files) instrumentation technique for pulpectomy in primary mandibular molars.
MATERIALS AND METHODS
A double-blinded randomized controlled trial was designed, recruiting participants with pulpally involved primary mandibular molars requiring pulpectomy in the age group of 6-9 years old. Sixty primary mandibular molars were randomly allocated to either of the four intervention groups: Group I: 15 teeth were instrumented using hand K-files (control group); Group II: 15 teeth were instrumented with paediatric rotary files (Kedo-S); Group III: 15 teeth were instrumented with paediatric hand files Kedo-SH (experimental group) and Group IV: 15 teeth were instrumented with paediatric rotary file system Kedo-SG Blue. Instrumentation time was recorded during root canal preparation and post-operative quality of obturation in each group was also assessed. Extracted data was subjected to statistical analysis using Chi-square, One-way ANOVA and post hoc Tukey test.
RESULTS
Mean instrumentation time was significantly reduced for Kedo-SG Blue (2.7840 ± 0.34217) min-s followed by Kedo-S (3.4827 ± 0.48657), Kedo-SH (5.8800 ± 0.48345) min-s and hand K-files (6.2167 ± 0.30978) min-s (p = 0.0005). A statistically significant difference was found in the obturation quality (p = 0.001) between the four groups with higher percentage of optimal fillings observed with rotary Kedo-SG Blue (80%) followed by Kedo-SH (46.7%); Kedo-S (40.0%) and hand K-files (20%).
CONCLUSIONS
On comparative evaluation, a marked reduction in instrumentation time and superior quality of obturation was found with rotary Kedo-SG Blue file system followed by Kedo-SH, Kedo-S and hand K-files.",2020,"A statistically significant difference was found in the obturation quality (p = 0.001) between the four groups with higher percentage of optimal fillings observed with rotary Kedo-SG Blue (80%) followed by Kedo-SH (46.7%); Kedo-S (40.0%) and hand K-files (20%).
","['primary mandibular molars', 'participants with pulpally involved primary mandibular molars requiring pulpectomy in the age group of 6-9\xa0years old', 'pulpectomy in primary mandibular molars', 'Sixty primary mandibular molars']","['conventional hand K-files for pulpectomy', '15 teeth were instrumented using hand K-files (control group); Group II: 15 teeth were instrumented with paediatric rotary files (Kedo-S); Group III: 15 teeth were instrumented with paediatric hand files Kedo-SH (experimental group) and Group IV: 15 teeth were instrumented with paediatric rotary file system Kedo-SG Blue', 'paediatric manual (Kedo-SH) and rotary (Kedo-S and Kedo-SG Blue) with conventional manual (Hand K-files) instrumentation technique']","['Mean instrumentation time', 'instrumentation time and superior quality of obturation', 'Instrumentation time', 'obturation quality', 'instrumentation time and obturation quality']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction (morphologic abnormality)'}]",,0.0384459,"A statistically significant difference was found in the obturation quality (p = 0.001) between the four groups with higher percentage of optimal fillings observed with rotary Kedo-SG Blue (80%) followed by Kedo-SH (46.7%); Kedo-S (40.0%) and hand K-files (20%).
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Priyadarshini', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, 162, Poonamallee High road, Chennai, 600077, India.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Jeevanandan', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, 162, Poonamallee High road, Chennai, 600077, India.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Govindaraju', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, 162, Poonamallee High road, Chennai, 600077, India. glaavuu@gmail.com.'}, {'ForeName': 'E M G', 'Initials': 'EMG', 'LastName': 'Subramanian', 'Affiliation': 'Department of Paediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical Sciences, 162, Poonamallee High road, Chennai, 600077, India.'}]",European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry,['10.1007/s40368-020-00518-w']
414,32196954,Levocetirizine Oral Disintegrating Tablet: A Randomized Open-Label Crossover Bioequivalence Study in Healthy Japanese Volunteers.,"Levocetirizine is classified as a second-generation antihistamine. Levocetirizine is available for the treatment of allergic disorders such as allergic rhinitis and chronic idiopathic urticaria. This was a single-center, single-dose, open-label, randomized, 2-way crossover study in healthy Japanese male subjects consisting of 2 parts. Part 1 compared the bioavailability of levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT) taken with water in the fasted state in 24 subjects; all subjects completed this part of the trial. In part 2, the bioavailability of levocetirizine ODT without water was compared with that of levocetirizine IRT with water in the fasted state in 48 subjects; 47 subjects completed this part of the trial. Bioequivalence was demonstrated between levocetirizine IRT 5 mg and ODT 5 mg. The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.",2020,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","['Healthy Japanese Volunteers', '24 subjects', 'healthy Japanese male subjects consisting of 2 parts', '48 subjects; 47 subjects completed this part of the trial']","['levocetirizine ODT and levocetirizine IRT', 'levocetirizine ODT', 'Levocetirizine', 'Levocetirizine Oral Disintegrating Tablet', 'levocetirizine oral disintegrating tablet (ODT) and levocetirizine immediate-release tablet (IRT', 'levocetirizine IRT']","['serious adverse events, deaths, or adverse events']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}]","[{'cui': 'C1174893', 'cui_str': 'levocetirizine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.011894,"The safety profiles were generally similar between levocetirizine ODT and levocetirizine IRT, with no serious adverse events, deaths, or adverse events leading to withdrawal reported during the study.","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ino', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Masanari', 'Initials': 'M', 'LastName': 'Shiramoto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Eto', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Miwa', 'Initials': 'M', 'LastName': 'Haranaka', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'Souseikai Hakata Clinic, Fukuoka, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Terao', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Wakamatsu', 'Affiliation': 'Pre-Clinical Development Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Hoyano', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakano', 'Affiliation': 'Immuno-Inflammation Therapeutic Office, Medicines Development, Japan Development, GlaxoSmithKline KK, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.791']
415,32196976,The Bioequivalence of Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine 4 × 20-mg Capsules in Healthy Volunteers.,"Tafamidis, a non-nonsteroidal anti-inflammatory benzoxazole derivative, acts as a transthyretin (TTR) stabilizer to slow progression of TTR amyloidosis (ATTR). Tafamidis meglumine, available as 20-mg capsules, is approved in more than 40 countries worldwide for the treatment of adults with early-stage symptomatic ATTR polyneuropathy. This agent, administered as an 80-mg, once-daily dose (4 × 20-mg capsules), is approved in the United States, Japan, Canada, and Brazil for the treatment of hereditary and wild-type ATTR cardiomyopathy in adults. An alternative single solid oral dosage formulation (tafamidis 61-mg free acid capsules) was developed and introduced for patient convenience (approved in the United States, United Arab Emirates, and European Union). In this single-center, open-label, randomized, 2-period, 2-sequence, crossover, multiple-dose phase 1 study, the rate and extent of absorption were compared between tafamidis 61-mg free acid capsules (test) and tafamidis meglumine 80-mg (4 × 20-mg) capsules (reference) after 7 days of repeated oral dosing under fasted conditions in 30 healthy volunteers. Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125). Both tafamidis regimens had an acceptable safety/tolerability profile in this population.",2020,"Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125).","['30 healthy volunteers', 'adults with early-stage symptomatic ATTR polyneuropathy', 'Healthy Volunteers']","['Tafamidis 61-mg Free Acid Capsules and Tafamidis Meglumine', 'Tafamidis meglumine']","['acceptable safety/tolerability profile', 'Ratios of adjusted geometric means (90%CI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C2745275', 'cui_str': 'Tafamidis meglumine'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",30.0,0.0586977,"Ratios of adjusted geometric means (90%CI) for the test/reference formulations were 102.3 (98.0-106.8) for area under the concentration-time profile over the dosing interval and 94.1 (89.1-99.4) for the maximum observed concentration, satisfying prespecified bioequivalence acceptance criteria (90%CI, 80-125).","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Lockwood', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Vu H', 'Initials': 'VH', 'LastName': 'Le', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': ""O'Gorman"", 'Affiliation': 'Pfizer, New York, New York, USA.'}, {'ForeName': 'Terrell A', 'Initials': 'TA', 'LastName': 'Patterson', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}, {'ForeName': 'Marla B', 'Initials': 'MB', 'LastName': 'Sultan', 'Affiliation': 'Pfizer, New York, New York, USA.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Tankisheva', 'Affiliation': 'Pfizer, Brussels, Belgium.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Pfizer Beijing City, China.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Pfizer, Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.789']
416,32185203,Influence of Hydroxyapatite Coating for the Prevention of Bone Mineral Density Loss and Bone Metabolism after Total Hip Arthroplasty: Assessment Using 18 F-Fluoride Positron Emission Tomography and Dual-Energy X-Ray Absorptiometry by Randomized Controlled Trial.,"Background
Hydroxyapatite- (HA-) coated implants tend to achieve good osteoinductivity and stable clinical results; however, the influence of the coating on the prevention of bone mineral density (BMD) loss around the implant is unclear. The purpose of this randomized controlled trial was to evaluate the effectiveness of HA-coated implants for preventing BMD loss and to determine the status of bone remodeling after total hip arthroplasty (THA), making comparisons with non-HA-coated implants.
Methods
A total of 52 patients who underwent primary THA were randomly allocated to HA and non-HA groups. BMD was measured by dual-energy X-ray absorptiometry (DEXA) at 1 week postoperation to form a baseline measurement, and then 24 weeks and 48 weeks after surgery. The relative change in BMD was evaluated for regions of interest (ROIs) based on the Gruen zone classifications. 18 F-fluoride positron emission tomography (PET) was performed at 24 weeks postsurgery, and the maximum standardized uptake values (SUV max ) were evaluated in the proximal (HA-coated) and distal (non-HA-coated) areas in both groups.
Results
There were significant differences in BMD loss in ROIs 3 and 6 ( p = 0.03), while no significant difference was observed in ROI 7 at either 24 or 48 weeks postsurgery. There was no significant correlation between PET uptake and BMD (24 or 48 weeks) in either group.
Conclusion
The influence of a HA coating in terms of BMD preservation is limited. No significant correlation was found between BMD and SUV max measured by PET, either with or without the use of a HA coating.",2020,"There were significant differences in BMD loss in ROIs 3 and 6 ( p = 0.03), while no significant difference was observed in ROI 7 at either 24 or 48 weeks postsurgery.","['52 patients who underwent primary THA', 'after Total Hip Arthroplasty']","['HA-coated implants', '18 F-fluoride positron emission tomography (PET', 'Hydroxyapatite Coating', '\n\n\nHydroxyapatite', 'HA coating']","['BMD', 'PET uptake and BMD', 'BMD loss', 'maximum standardized uptake values (SUV max ', 'BMD and SUV max', 'bone mineral density (BMD) loss', 'Bone Mineral Density Loss and Bone Metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C0016327', 'cui_str': 'Fluorides'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0115137', 'cui_str': 'Durapatite'}]","[{'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",52.0,0.0919206,"There were significant differences in BMD loss in ROIs 3 and 6 ( p = 0.03), while no significant difference was observed in ROI 7 at either 24 or 48 weeks postsurgery.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Tezuka', 'Affiliation': 'Department of Orthopedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Orthopaedic Surgery, Yokohama City University Medical Center, 4-57 Urafunecho, Minami-ku, Yokohama, Japan.'}, {'ForeName': 'Choe', 'Initials': 'C', 'LastName': 'Hyonmin', 'Affiliation': 'Department of Orthopedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Oba', 'Affiliation': 'Department of Orthopedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Miyamae', 'Affiliation': 'Department of Orthopedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Morita', 'Affiliation': 'Department of Orthopedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Department of Orthopedic Surgery, Yokohama City University, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.'}]",BioMed research international,['10.1155/2020/4154290']
417,32192908,"The traditional versus endoscopic-assisted latissimus dorsi harvest in oncoplastic surgery: A long term comparison of breast volume, aesthetics, and donor site outcomes.","BACKGROUND/OBJECTIVE
Volume replacement with the latissimus dorsi (LD) is an option for patients after partial mastectomy. Although potential benefits of using the endoscopic technique have been previously described, previous studies have not assessed long term volume and aesthetic outcomes compared to traditional methods. In this study, we aim to compare the endoscopic, latissimus only harvest to the traditional latissimus with skin paddle method.
METHODS
Eleven patients underwent breast reconstruction with the traditional LD flap harvesting method; 9 underwent endoscopically assisted LD flap reconstruction. The difference between preoperative and >1 year postoperative volumes were recorded. Patient satisfaction and surgeon-based observer assessment of the breast aesthetic and donor site scar were compared between the two techniques.
RESULTS
Compared to the traditional group, there was a significant mean volume reduction in the endoscopic group (70.3 vs 21.7 cc, p = 0.0023). Operative time was also longer in the endoscopic group than in the traditional group (368 vs 257 min, p < 0.001). In observer assessment criteria, the result of the donor site scar assessment was superior in the endoscopic group in terms of vascularity (p = 0.0038), relief (p = 0.0023), and pliability (p = 0.053).
CONCLUSION
Patients' attitudes and feelings about the scar were better in the endoscopic group than in the traditional group. However, compared to the endoscopic group, the traditional group achieved a better breast cosmetic result and better retention of volume postoperatively, possibly due to incorporation of the skin flap and adipo-fascial tissue.",2020,"Operative time was also longer in the endoscopic group than in the traditional group (368 vs 257 min, p < 0.001).","['patients after partial mastectomy', 'Eleven patients underwent']","['latissimus dorsi (LD', 'breast reconstruction with the traditional LD flap harvesting method; 9 underwent endoscopically assisted LD flap reconstruction', 'traditional versus endoscopic-assisted latissimus dorsi harvest in oncoplastic surgery']","['Operative time', 'relief', 'Patient satisfaction and surgeon-based observer assessment of the breast aesthetic and donor site scar', 'mean volume reduction', 'breast cosmetic result and better retention of volume postoperatively, possibly due to incorporation of the skin flap and adipo-fascial tissue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024885', 'cui_str': 'Local Excision Mastectomy'}]","[{'cui': 'C0224362', 'cui_str': 'Latissimus Dorsi'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C1444716', 'cui_str': 'Donor site (attribute)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C1562051', 'cui_str': 'Skin flap'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",11.0,0.0254922,"Operative time was also longer in the endoscopic group than in the traditional group (368 vs 257 min, p < 0.001).","[{'ForeName': 'Hsien Pin', 'Initials': 'HP', 'LastName': 'Chang', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Fan', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, MedStar Georgetown University Hospital, Washington DC, USA.'}, {'ForeName': 'Seung Yong', 'Initials': 'SY', 'LastName': 'Song', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: xyphoss@yuhs.ac.'}]",Asian journal of surgery,['10.1016/j.asjsur.2020.03.002']
418,32193249,Effects of Intensive Glycemic Control on Clinical Outcomes Among Patients With Type 2 Diabetes With Different Levels of Cardiovascular Risk and Hemoglobin A 1c in the ADVANCE Trial.,"OBJECTIVE
To study whether the effects of intensive glycemic control on major vascular outcomes (a composite of major macrovascular and major microvascular events), all-cause mortality, and severe hypoglycemia events differ among participants with different levels of 10-year risk of atherosclerotic cardiovascular disease (ASCVD) and hemoglobin A 1c (HbA 1c ) at baseline.
RESEARCH DESIGN AND METHODS
We studied the effects of more intensive glycemic control in 11,071 patients with type 2 diabetes (T2D), without missing values, in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial, using Cox models.
RESULTS
During 5 years' follow-up, intensive glycemic control reduced major vascular events (hazard ratio [HR] 0.90 [95% CI 0.83-0.98]), with the major driver being a reduction in the development of macroalbuminuria. There was no evidence of differences in the effect, regardless of baseline ASCVD risk or HbA 1c level ( P for interaction = 0.29 and 0.94, respectively). Similarly, the beneficial effects of intensive glycemic control on all-cause mortality were not significantly different across baseline ASCVD risk ( P = 0.15) or HbA 1c levels ( P = 0.87). The risks of severe hypoglycemic events were higher in the intensive glycemic control group compared with the standard glycemic control group (HR 1.85 [1.41-2.42]), with no significant heterogeneity across subgroups defined by ASCVD risk or HbA 1c at baseline ( P = 0.09 and 0.18, respectively).
CONCLUSIONS
The major benefits for patients with T2D in ADVANCE did not substantially differ across levels of baseline ASCVD risk and HbA 1c .",2020,"The risks of severe hypoglycemic events were higher in the intensive glycemic control group compared with the standard glycemic control group (HR 1.85 [1.41-2.42]), with no significant heterogeneity across subgroups defined by ASCVD risk or HbA 1c at baseline ( P = 0.09 and 0.18, respectively).
","['Patients With Type 2 Diabetes With Different Levels of Cardiovascular Risk and Hemoglobin A 1c in the ADVANCE Trial', 'participants with different levels of 10-year risk of atherosclerotic cardiovascular disease (ASCVD) and hemoglobin A 1c (HbA 1c ) at baseline', '11,071 patients with type 2 diabetes (T2D), without missing values, in the Action in Diabetes and Vascular Disease']","['Intensive Glycemic Control', 'intensive glycemic control']","['levels of baseline ASCVD risk and HbA 1c ', 'baseline ASCVD risk or HbA 1c level', 'ASCVD risk or HbA 1c', 'risks of severe hypoglycemic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0019018', 'cui_str': 'Glycated Hemoglobin A'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",11071.0,0.0675695,"The risks of severe hypoglycemic events were higher in the intensive glycemic control group compared with the standard glycemic control group (HR 1.85 [1.41-2.42]), with no significant heterogeneity across subgroups defined by ASCVD risk or HbA 1c at baseline ( P = 0.09 and 0.18, respectively).
","[{'ForeName': 'Jingyan', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'State Key Laboratory of Medical Genomics, Shanghai Institute of Endocrine and Metabolic Diseases, Department of Endocrinology and Metabolism, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ohkuma', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harrap', 'Affiliation': 'The University of Melbourne and The Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Istituto Auxologico Italiano, University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Poulter', 'Affiliation': 'International Center for Circulatory Health, Imperial College, London, U.K.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension, Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zoungas', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia chalmers@georgeinstitute.org.au.'}]",Diabetes care,['10.2337/dc19-1817']
419,32141343,Comparative study of dulaglutide single-use pen Ateos versus insulin degludec FlexTouch on learning and mock administration time in Japanese patients with type 2 diabetes mellitus - a post-hoc analysis.,"Aims: Clinical data have shown that patients with diabetes require shorter training time to use Ateos versus FlexTouch. Using data acquired from a previous study, self-administration procedures that necessitated more time and repetition during mock injection were evaluated. Methods: In this open-label task- and interview-based crossover study, 48 self-injection naïve participants with type 2 diabetes mellitus (T2DM) were randomized to 1 of 2 sequences to perform a mock injection of Ateos and FlexTouch into a rubber pad after receiving training. Time needed to conduct mock injection steps (preparation, pre-injection set-up, injection, clean-up), and the number and time needed for repeated steps due to procedural errors, were measured as post-hoc analyses. Results: Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 s) versus FlexTouch (96, 53, 36 s). Overall time for administration including repeated steps was 75 s for Ateos and 288 s for FlexTouch. Nine participants repeated procedures due to errors when using Ateos (preparation: 6; pre-injection set-up: 2; injection: 1), and 7 participants when using FlexTouch (preparation: 2; pre-injection set-up: 2; injection: 5). There was 1 repeat per person for Ateos injections versus multiple repeats for FlexTouch injections. Conclusions: Post-hoc analysis demonstrates the time needed for overall administration was shorter for Ateos than FlexTouch, and time for each procedure was shorter or similar for Ateos versus FlexTouch. Ateos was easy for participants with T2DM to learn with fewer repeated steps due to procedural errors, and easy for healthcare professionals to introduce to their patients.",2020,"Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 seconds) versus FlexTouch (96, 53, 36 seconds).","['48 self-injection naïve participants with type 2 diabetes mellitus (T2DM', 'patients with diabetes', 'Japanese patients with type 2 diabetes']","['dulaglutide single-use pen Ateos versus insulin degludec FlexTouch', 'FlexTouch', 'mock injection of Ateos and FlexTouch into a rubber pad after receiving training']","['Overall time', 'Mean time for preparation, injection, and clean-up']","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0035918', 'cui_str': 'Natural Rubber'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}]",,0.027082,"Mean time for preparation, injection, and clean-up was shorter for Ateos (13, 15, 9 seconds) versus FlexTouch (96, 53, 36 seconds).","[{'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Asakura', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan.'}, {'ForeName': 'Toshinobu', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Niigata University of Pharmacy and Applied Life Sciences, Niigata, Japan.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Cai', 'Affiliation': 'Statistical Science, Medicines Development Unit-Japan, Eli Lilly Japan K.K, Kobe, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Aranishi', 'Affiliation': 'Health Outcomes, Health Technology Assessment, Real World Evidence, Medicines Development Unit-Japan, Eli Lilly Japan K.K., Kobe, Japan.'}]",Current medical research and opinion,['10.1080/03007995.2020.1739636']
420,31808131,"Medical Scribes, Provider and Patient Experience, and Patient Throughput: a Trial in an Academic General Internal Medicine Practice.","BACKGROUND
Medical scribes have been proposed as a solution to the problems of excessive documentation, work-life balance, and burnout facing general internists. However, their acceptability to patients and effects on provider experience have not been tested in a real-world model of effectiveness.
OBJECTIVE
To measure the effect of medical scribes on patient satisfaction, provider satisfaction, and provider productivity.
DESIGN
Quasi-experimental difference-in-differences longitudinal design.
PARTICIPANTS
Four attending physicians who worked with scribes, 9 control physicians who did not, and their patients in a large, hospital-affiliated academic general internal medicine practice.
MAIN MEASURES
Provider experience and patient experience using 5-point Likert scale surveys from the AMA Steps Forward Team Documentation Module, and visits and wRVUs per hour during 4 weeks before and 12 weeks after initiation of a practice model that included use of scribes and a shortened visit template.
KEY RESULTS
Participating providers worked a total of 664 clinic sessions and returned 547 (82%) surveys. Average provider experience scores did not differ between providers working with scribes and control providers working without (4.01 vs. 3.40 respectively; p time-by-group interaction = 0.26). Providers with scribes were more likely to agree that work for the encounter would be completed during the visit then controls (3.58 vs. 2.48 respectively; p interaction = 0.04). A total of 6202 visits occurred during the study period. Average patient experience scores did not differ between the experimental and control groups (4.73 vs. 4.75 respectively; p interaction = 0.90). Compared with the control providers, providers with scribes completed more visits per hour (2.29 vs. 1.91; p interaction < 0.001) and generated more wRVUs per hour (3.42 vs. 3.27; p interaction < 0.001).
CONCLUSIONS
In this test of a modified practice model, scribes supported greater patient throughput and improved provider perceptions of documentation burden with no decrement in high patient satisfaction.",2020,Average patient experience scores did not differ between the experimental and control groups (4.73 vs. 4.75 respectively; p interaction = 0.90).,"['Four attending physicians who worked with scribes, 9 control physicians who did not, and their patients in a large, hospital-affiliated academic general internal medicine practice', 'Participating providers worked a total of 664 clinic sessions and returned 547 (82%) surveys']",[],"['Average provider experience scores', 'Average patient experience scores', 'Provider experience and patient experience using 5-point Likert scale surveys from the AMA Steps Forward Team Documentation Module, and visits and wRVUs per hour', 'patient satisfaction, provider satisfaction, and provider productivity']","[{'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}]",,0.062576,Average patient experience scores did not differ between the experimental and control groups (4.73 vs. 4.75 respectively; p interaction = 0.90).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Heckman', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA. jaheckma@bidmc.harvard.edu.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Christensen', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Eileen E', 'Initials': 'EE', 'LastName': 'Reynolds', 'Affiliation': 'Division of General Internal Medicine and Primary Care, Beth Israel Deaconess Medical Center, East Campus, Shapiro Clinical Center, 330 Brookline Ave, Boston, MA, 02215, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05352-5']
421,31362299,High-Flux versus High-Retention-Onset Membranes: In vivo Small and Middle Molecules Kinetics in Convective Dialysis Modalities.,"BACKGROUND
Patients undergoing maintenance hemodialysis (HD) exhibit increased levels of uremic toxins, which are associated with poor outcomes. Recently, new dialysis membranes have allowed clearance of solutes with higher molecular weight, without significant albumin losses high-retention-onset-HD (HRO-HD).
METHODS
Prospective crossover trial, in which 16 prevalent patients switched from high-flux HD (HF-HD) to online hemodiafiltration (olHDF) and HRO-HD for 4 weeks. The following variables were evaluated: pre- and post-dialysis serum concentrations of albumin, urea, phosphate (P), beta-2 microglobulin (β2M), and total mass (TM) extraction and dialyzer clearance of urea, P, and β2M.
RESULTS
Comparing HF-HD, olHDF, and HRO-HD, respectively, there were no differences regarding pre-dialysis serum concentrations of albumin (3.94 ± 0.36, 4.06 ± 0.22, and 3.93 ± 0.41 g/dL, p = 0.495), urea (166 ± 29, 167 ± 30, and 164 ± 27 mg/dL, p = 0.971), P (4.9 ± 2.1, 5.2 ± 1.6, and 4.9 ± 2.1 mg/dL, p = 0.879), and β2M (31.3 ± 7.1, 32.6 ± 8.6, and 33.7 ± 5.9 µg/mL, p = 0.646). β2M clearance was significantly lower in HF-HD in comparison to both olHDF and HRO-HD: 43 (37-53) versus 64 (48-85) mL/min, p = 0.013, and 69 (58-86) mL/min, p = 0.015, respectively. Post-dialysis β2M serum concentration was higher in HF-HD in comparison to olHDF and HRO-HD: 11.6 (9.6-12.4) vs. 5.7 (4.5-7.0) µg/mL, p = 0.001, and 5.6 (5.3-7.6) µg/mL, p = 0.001, respectively. TM extraction of urea, P, and β2M were similar across the 3 dialysis modalities.
CONCLUSIONS
olHDF and HRO-HD were superior to HF-HD regarding β2M clearance, leading to lower post-dialysis β2M levels.",2020,"Post-dialysis β2M serum concentration was higher in HF-HD in comparison to olHDF and HRO-HD: 11.6 (9.6-12.4) vs. 5.7 (4.5-7.0) µg/mL, p = 0.001, and 5.6 (5.3-7.6) µg/mL, p = 0.001, respectively.","['Patients undergoing maintenance hemodialysis (HD', '16 prevalent patients switched from high-flux HD (HF-HD) to online hemodiafiltration (olHDF) and HRO-HD for 4 weeks']",['High-Flux versus High-Retention-Onset Membranes'],"['pre- and post-dialysis serum concentrations of albumin, urea, phosphate (P), beta-2 microglobulin (β2M), and total mass (TM) extraction and dialyzer clearance of urea, P, and β2M.\nRESULTS\n\n\nComparing HF-HD, olHDF, and HRO-HD', 'TM extraction of urea, P, and β2M', 'M clearance', 'Post-dialysis β2M serum concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1264635', 'cui_str': 'Post-dialysis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0201910', 'cui_str': 'Beta-2-microglobulin measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",16.0,0.0369393,"Post-dialysis β2M serum concentration was higher in HF-HD in comparison to olHDF and HRO-HD: 11.6 (9.6-12.4) vs. 5.7 (4.5-7.0) µg/mL, p = 0.001, and 5.6 (5.3-7.6) µg/mL, p = 0.001, respectively.","[{'ForeName': 'Isis S F', 'Initials': 'ISF', 'LastName': 'Cordeiro', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Cordeiro', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carolina S', 'Initials': 'CS', 'LastName': 'Wagner', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Luiza Karla R P', 'Initials': 'LKRP', 'LastName': 'Araújo', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Benedito J', 'Initials': 'BJ', 'LastName': 'Pereira', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Abensur', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rosilene M', 'Initials': 'RM', 'LastName': 'Elias', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bruno C', 'Initials': 'BC', 'LastName': 'Silva', 'Affiliation': 'Renal Division, Department of Medicine, Hospital das Clinicas HCFMUSP, Universidade de São Paulo, São Paulo, Brazil, brunocaldin@hotmail.com.'}]",Blood purification,['10.1159/000502082']
422,31367875,Impact of Adding Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge: a Randomized Controlled Trial.,"BACKGROUND
Cessation counseling and pharmacotherapy are recommended for hospitalized smokers, but better coordination between cessation counselors and providers might improve utilization of pharmacotherapy and enhance smoking cessation.
OBJECTIVE
To compare smoking cessation counseling combined with care coordination post-hospitalization to counseling alone on uptake of pharmacotherapy and smoking cessation.
DESIGN
Unblinded, randomized clinical trial PARTICIPANTS: Hospitalized smokers referred from primarily rural hospitals INTERVENTIONS: Counseling only (C) consisted of telephone counseling provided during the hospitalization and post-discharge. Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker's health care team and help for the smoker in obtaining pharmacotherapy. At 6 months post-hospitalization, persistent smokers were re-engaged with either CCC or C.
MAIN MEASURES
Utilization of pharmacotherapy and smoking cessation at 3, 6, and 12 months post-discharge.
KEY RESULTS
Among 606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis. Use of any cessation pharmacotherapy between 0 and 6 months (55.2%) and between 6 and 12 months (47.1%) post-discharge was similar across treatment arms though use of prescription-only pharmacotherapy between months 6-12 was significantly higher in the CCC group (30.1%) compared with the C group (18.6%) (RR, 1.61 (95% CI, 1.08, 2.41)). Self-reported abstinence rates of 26.2%, 20.3%, and 23.4% at months 3, 6, and 12, respectively, were comparable across the two treatment arms. Of those smoking at month 6, 12.5% reported abstinence at month 12. Validated smoking cessation at 12 months was 19.3% versus 16.9% in the CCC and C groups, respectively (RR, 1.13 (95% CI, 0.80, 1.61)).
CONCLUSION
Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone. Re-engagement of smokers 6 months post-discharge can lead to new quitters, at which time care coordination might facilitate use of prescription medications.
TRIAL REGISTRATION
NCT01063972.",2019,"Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone.","['hospitalized smokers', '606 smokers randomized, 429 (70.8%) completed the 12-month assessment and 580 (95.7%) were included in the primary analysis', 'Hospitalized smokers referred from primarily rural hospitals']","[""Counseling with care coordination (CCC) provided similar counseling supplemented by feedback to the smoker's health care team and help for the smoker in obtaining pharmacotherapy"", 'telephone counseling', 'Telephone-Based Care Coordination to Standard Telephone-Based Smoking Cessation Counseling Post-hospital Discharge', 'CCC', 'smoking cessation counseling combined with care coordination post-hospitalization to counseling alone']","['Utilization of pharmacotherapy and smoking cessation', 'Self-reported abstinence rates', 'Validated smoking cessation']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517818', 'cui_str': 'Five hundred and eighty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0020023', 'cui_str': 'Hospitals, Rural'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086390', 'cui_str': 'Medical Care Team'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",606.0,0.0510976,"Supplemental care coordination, provided by counselors outside of the health care team, failed to improve smoking cessation beyond that achieved by cessation counseling alone.","[{'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Ellerbeck', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA. eellerbe@kumc.edu.'}, {'ForeName': 'Lisa Sanderson', 'Initials': 'LS', 'LastName': 'Cox', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Siu-Kuen Azor', 'Initials': 'SA', 'LastName': 'Hui', 'Affiliation': 'Philadelphia Department of Public Health, Philadelphia, PA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keighley', 'Affiliation': 'Department of Biostatistics, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Tresza D', 'Initials': 'TD', 'LastName': 'Hutcheson', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'A Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}, {'ForeName': 'K Allen', 'Initials': 'KA', 'LastName': 'Greiner', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Rigotti', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nancy Houston', 'Initials': 'NH', 'LastName': 'Miller', 'Affiliation': 'The LifeCare Company, Menlo Park, CA, USA.'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Rabius', 'Affiliation': 'Department of Behavioral Science, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Population Health, University of Kansas Medical Center, 3901 Rainbow Blvd., MS 1008, Kansas City, KS, 66160, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05220-2']
423,31775016,Intralymphatic immunotherapy in pollen-allergic young adults with rhinoconjunctivitis and mild asthma: A randomized trial.,,2020,"Four intralymphatic allergen injections for treatment of pollen allergy reduce medication use, improve symptoms and have immune modulating effects in adolescents and young adults with rhinoconjunctivitis and mild asthma due to birch or grass pollen.","['adolescents and young adults with rhinoconjunctivitis and mild asthma due to birch or grass pollen', 'pollen allergic young adults with rhinoconjunctivitis and mild asthma']",['Intralymphatic immunotherapy'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0330312', 'cui_str': 'Birch'}, {'cui': 'C0440307', 'cui_str': 'Grass pollen (substance)'}, {'cui': 'C0032385', 'cui_str': 'Pollen Grains'}]","[{'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]",[],,0.164171,"Four intralymphatic allergen injections for treatment of pollen allergy reduce medication use, improve symptoms and have immune modulating effects in adolescents and young adults with rhinoconjunctivitis and mild asthma due to birch or grass pollen.","[{'ForeName': 'Jon R', 'Initials': 'JR', 'LastName': 'Konradsen', 'Affiliation': ""Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden; Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Grundström', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Hellkvist', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden; Department of ENT Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Thi Anh Thu', 'Initials': 'TAT', 'LastName': 'Tran', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Andersson', 'Affiliation': 'Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Guro', 'Initials': 'G', 'LastName': 'Gafvelin', 'Affiliation': 'Therapeutic Immune Design Unit, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'M B Gea', 'Initials': 'MBG', 'LastName': 'Kiewiet', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Hamsten', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jiaqian', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College, London, United Kingdom; MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Rebecca V', 'Initials': 'RV', 'LastName': 'Parkin', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College, London, United Kingdom; MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Mohamed H', 'Initials': 'MH', 'LastName': 'Shamji', 'Affiliation': 'Immunomodulation and Tolerance Group, Allergy and Clinical Immunology, Section of Inflammation, Repair and Development, National Heart and Lung Institute, Imperial College, London, United Kingdom; MRC & Asthma UK Centre in Allergic Mechanisms of Asthma, London, United Kingdom.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Hedlin', 'Affiliation': ""Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Lars-Olaf', 'Initials': 'LO', 'LastName': 'Cardell', 'Affiliation': 'Division of ENT Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden; Department of ENT Diseases, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'van Hage', 'Affiliation': 'Department of Medicine Solna, Division of Immunology and Allergy, Karolinska Institutet and University Hospital, Stockholm, Sweden. Electronic address: Marianne.van.Hage@ki.se.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.11.017']
424,32176674,Non-immersive Virtual Reality Rehabilitation Applied to a Task-oriented Approach for Stroke Patients: A Randomized Controlled Trial.,"BACKGROUND
Virtual reality (VR) training allows the creation of the most applicable practice environment incorporated into computer-generated multisensory imagery.
OBJECTIVES
The purpose of this study was to investigate the effects of a virtual training program based on a RAPAEL smart glove on the upper extremity function and quality of life of community-dwelling individuals with chronic hemiparetic stroke.
METHODS
Thirty-six outpatients diagnosed as having a first stroke were selected to receive a therapeutic rehabilitation program at local rehabilitation units. Participants were allocated randomly into two groups: the non-immersive VR training (intervention) group and the recreational activity (control) group. The intervention group received non-immersive VR training using a RAPAEL smart glove for 30 minutes per session, 3 days a week for 8 weeks. The control group performed recreational activities for the same period and also participated in a conventional rehabilitation program for 30 minutes per session, 3 days a week for 8 weeks as an additional therapy. To analyze the effects of the non-immersive VR intervention on upper extremity function, four clinical measures, namely the box and block test (BBT), the Wolf motor function test (WMFT), the Jebsen-Taylor hand function test (JTT), and a grip strength test, were used in this study. For the secondary clinical outcome, the trail-making test (TMT) was used to determine any improvement in cognitive function.
RESULTS
At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
CONCLUSIONS
This study suggests that virtual upper extremity training using the RAPAEL smart glove has reasonable and beneficial effects on upper extremity and cognitive function for chronic hemiparetic stroke survivors.",2020,"At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
","['Stroke Patients', 'community-dwelling individuals with chronic hemiparetic stroke', 'chronic hemiparetic stroke survivors', 'Thirty-six outpatients diagnosed as having a first stroke']","['virtual training program', 'non-immersive VR intervention', 'Virtual reality (VR) training', 'non-immersive VR training', 'non-immersive VR training (intervention) group and the recreational activity (control) group', 'therapeutic rehabilitation program at local rehabilitation units']","['cognitive function', 'upper extremity function and quality of life', 'trail-making test (TMT', 'box-block test (BBT), the Wolf motor function test (WMFT), the Jebsen-Taylor hand function test (JTT', 'grip strength', 'recreational activities', 'WMFT scores', 'BBT scores']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.0138026,"At week 8, upon completion of the non-immersive VR-training the intervention group demonstrated significantly greater WMFT scores (73.0±12.9 to 81.6±7.5), BBT scores (27.3±8.9 to 34.2±7.1), and grip strength (19.2±8.2 to 23.8±8.5) compared with WMFT scores (70.4±12.1 to 73.2±13.1), BBT scores (27.1±10.5 to 28.8±12.9), and grip strength (18.4±4.2 to 18.3±4.9) in the control group.
","[{'ForeName': 'Hye-Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': ""Department of Occupational Therapy, Gwang-ju Women's University, Gwangju, Republic of Korea.""}, {'ForeName': 'Jae-Heon', 'Initials': 'JH', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, Wonkwang Health Science University, Jeollabuk-do, Republic of Korea.'}, {'ForeName': 'Byeong-Hyeon', 'Initials': 'BH', 'LastName': 'Jeon', 'Affiliation': 'Department of Physical Therapy, Graduate school, Honam University, Gwangju, Republic of Korea.'}, {'ForeName': 'Chiang-Soon', 'Initials': 'CS', 'LastName': 'Song', 'Affiliation': 'Deparment of Occupational Therapy, College of Health Science, Chosun University, Gwangju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-190975']
425,31657637,Cooling of Lower Extremity Muscles According to Subcutaneous Tissue Thickness.,"CONTEXT
When using an ice bag, previous researchers recommended cooling times based on the amount of subcutaneous tissue. Unfortunately, many clinicians are unaware of these recommendations or whether they can be applied to other muscles.
OBJECTIVE
To examine if muscles of the lower extremity cool similarly based on recommended cooling times.
DESIGN
Crossover study.
SETTING
Athletic training laboratory.
PATIENTS OR OTHER PARTICIPANTS
Fourteen healthy participants volunteered (8 men, 6 women; age = 21.1 ± 2.2 years, height = 174.2 ± 4.5 cm, weight = 74.0 ± 7.5 kg).
INTERVENTION(S)
Subcutaneous tissue thickness was measured at the largest girth of the thigh, medial gastrocnemius, and medial hamstring. Participants were randomized to have either the rectus femoris or medial gastrocnemius and medial hamstring tested first. Using sterile techniques, the examiner inserted a thermocouple 1 cm into the muscle after accounting for subcutaneous tissue thickness. After the temperature stabilized, a 750-g ice bag was applied for 10 to 60 minutes to the area(s) for the recommended length of time based on subcutaneous adipose thickness (0 to 5 mm [10 minutes]; 5.5 to 10 mm (25 minutes]; 10.5 to 15 mm [40 minutes]; 15.5 to 20 mm [60 minutes)]. After the ice bag was removed, temperature was monitored for 30 minutes. At least 1 week later, each participant returned to complete testing of the other muscle(s).
MAIN OUTCOME MEASURE(S)
Intramuscular temperature (°C) at baseline, end of treatment time (0 minutes), and posttreatment recovery (10, 20, and 30 minutes postintervention).
RESULTS
At the end of treatment, temperature did not differ by subcutaneous tissue thickness (10 minutes = 29.0°C ± 3.8°C, 25 minutes = 28.7°C ± 3.2°C, 40 minutes = 28.7°C ± 6.0°C, 60 minutes = 30.0°C ± 2.9°C) or muscle (rectus femoris = 30.1°C ± 3.8°C, gastrocnemius = 28.6°C ± 5.4°C, hamstrings = 28.1°C ± 2.5°C). No significant interaction was present for subcutaneous tissue thickness or muscle ( P ≥ .126).
CONCLUSIONS
Lower extremity muscles seemed to cool similarly based on the recommended cooling times for subcutaneous tissue thickness. Clinicians should move away from standardized treatment times and adjust the amount of cooling time by ice-bag application based on subcutaneous tissue thickness.",2019,"At the end of treatment, temperature did not differ by subcutaneous tissue thickness (10 minutes = 29.0°C ± 3.8°C, 25 minutes =","['Lower Extremity Muscles', 'Athletic training laboratory', 'Fourteen healthy participants volunteered (8 men, 6 women; age = 21.1 ± 2.2 years, height = 174.2 ± 4.5 cm, weight = 74.0 ± 7.5 kg']",[],"['subcutaneous tissue thickness', 'subcutaneous tissue thickness or muscle']","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1510656', 'cui_str': 'Athletics'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]",[],"[{'cui': 'C0278403', 'cui_str': 'Tela Subcutanea'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]",14.0,0.0277646,"At the end of treatment, temperature did not differ by subcutaneous tissue thickness (10 minutes = 29.0°C ± 3.8°C, 25 minutes =","[{'ForeName': 'Noelle M', 'Initials': 'NM', 'LastName': 'Selkow', 'Affiliation': 'School of Kinesiology and Recreation, Illinois State University, Normal.'}]",Journal of athletic training,['10.4085/1062-6050-550-18']
426,31711065,Repetitive transcranial magnetic stimulation targeting the insular cortex for reduction of heavy drinking in treatment-seeking alcohol-dependent subjects: a randomized controlled trial.,"Insula responses to drug cues are correlated with cravings, and lesions in this area reduce nicotine seeking. Here, we investigated the potential efficacy of repetitive transcranial magnetic stimulation (rTMS) targeting the insula in alcohol addiction. Treatment-seeking alcohol-dependent patients (Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition; N = 56) participated in this double-blind, sham-controlled, randomized trial. Participants received 10 Hz rTMS or sham using an H8 coil, 5 days a week for 3 weeks. Stimulation targeted insular cortex and overlaying regions bilaterally, while excluding anterior prefrontal areas. Craving and self-reported as well as biomarker-based drinking measures were collected at baseline, during treatment, and through 12 weeks. Resting-state magnetic resonance imaging (rsMRI) data were collected before and after treatment. Task-based MRI was used to probe brain correlates of reward processing, affective responses, and alcohol following completion of treatment. A marked overall decrease in craving and drinking measures was observed during treatment, but did not differ between rTMS or sham stimulation. Both groups equally increased their alcohol use following completion of treatment and through the 12-week follow-up. Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function. However, while each task robustly replicated brain responses established in the literature, no effects of rTMS were found. Collectively, this study does not support efficacy of rTMS targeting the insula in alcohol addiction.",2020,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.",['treatment-seeking alcohol-dependent subjects'],"['Repetitive transcranial magnetic stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\u2009Hz rTMS']","['heavy drinking', 'craving and drinking measures']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0893144,"Analysis using seeds in the insula identified differences in resting-state connectivity between active and sham groups at completion of treatment, potentially indicating an ability of treatment to modify insula function.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Perini', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden. irene.perini@liu.se.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kämpe', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Theodor', 'Initials': 'T', 'LastName': 'Arlestig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Löfberg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Pietrzak', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'Department of Life Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Department of Clinical and Experimental Medicine, Center for Social and Affective Neuroscience, Linköping University, Linköping, 581 83, Sweden.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0565-7']
427,31183919,Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study.,"BACKGROUND
Resuscitation with crystalloid fluid is a cornerstone of pediatric septic shock treatment. However, the optimal type of crystalloid fluid is unknown. We aimed to determine the feasibility of conducting a pragmatic randomized trial to compare balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation in children with suspected septic shock.
METHODS
Open-label pragmatic randomized controlled trial at a single academic children's hospital from January to August 2018. Eligible patients were >6 months to <18 years old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either LR or NS for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team's discretion. Feasibility outcomes included proportion of eligible patients enrolled, acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and adherence to randomized study fluid administration.
RESULTS
Of 59 eligible patients, 50 (85%) were enrolled and randomized. Twenty-four were randomized to LR and 26 to NS. Only one (2%) of 44 patients enrolled using EFIC withdrew before study completion. Total median (interquartile range [IQR]) crystalloid fluid volume received during the intervention window was 107 (60 to 155) mL/kg and 98 (63 to 128) mL/kg in the LR and NS arms, respectively (p = 0.50). Patients randomized to LR received a median (IQR) of only 20% (13 to 32) of all study fluid as NS compared to 99% (64% to 100%) of study fluid as NS in the NS arm (absolute difference = 79%, 95% CI = 48% to 85%).
CONCLUSIONS
A pragmatic study design proved feasible to study comparative effectiveness of LR versus NS fluid resuscitation for pediatric septic shock.",2019,"Total median crystalloid fluid volume received during the intervention window was 107 (IQR 60, 155) mL/kg and 98 (IQR 63, 128) mL/kg in the LR and NS arms, respectively (p=0.50).","['Eligible patients were >6 months to <18 years-old who were treated in the emergency department for suspected septic shock, operationalized as blood culture, parenteral antibiotics, and fluid resuscitation for abnormal perfusion', 'children with suspected septic shock', 'Sepsis', '59 eligible patients, 50 (85%) were enrolled and randomized', ""single academic children's hospital from January - August 2018"", 'pediatric septic shock', '44 patients enrolled using EFIC withdrew before study completion']","['LR versus NS fluid resuscitation', 'LR', ""balanced (lactated Ringer's [LR]) with 0.9% normal saline (NS) fluid resuscitation"", 'LR or NS', 'Balanced versus nOrmaL Saline FlUid']",['Total median crystalloid fluid volume'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",44.0,0.510377,"Total median crystalloid fluid volume received during the intervention window was 107 (IQR 60, 155) mL/kg and 98 (IQR 63, 128) mL/kg in the LR and NS arms, respectively (p=0.50).","[{'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Balamuth', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Marlena', 'Initials': 'M', 'LastName': 'Kittick', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McBride', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Ashley L', 'Initials': 'AL', 'LastName': 'Woodford', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Vestal', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Metheney', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': ""Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Atkin', 'Affiliation': ""Department of Anesthesiology and Critical Care, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Baren', 'Affiliation': ""Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis Health, Sacramento, CA.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Weiss', 'Affiliation': ""Pediatric Sepsis Program, Children's Hospital of Philadelphia, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.""}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13815']
428,31515736,"""Getting Everyone on the Same Page"": Interprofessional Team Training to Develop Shared Mental Models on Interprofessional Rounds.","AIM
This study aimed to evaluate the effect of a team training program to support shared mental model (SMM) development in interprofessional rounds.
DESIGN AND PARTICIPANTS
A three-arm randomized controlled trial study was conducted for interprofessional teams of 207 health profession learners who were randomized into three groups.
PROGRAM DESCRIPTION
The full team training program included a didactic training part on cognitive tools and a virtual simulation to support clinical teamwork in interprofessional round. Group 1 was assigned to the full program, group 2 to the didactic part, and group 3 (control group) with no intervention. The main outcome measure was team performance in full scale simulation. Secondary outcome was interprofessional attitudes.
PROGRAM EVALUATION
Teamwork performance and interprofessional attitude scores of the full intervention group were significantly higher (P < 0.05) than those of the control group. The two intervention groups had significantly higher (P < 0.05) attitude scores on interprofessional teamwork compared with the control group.
DISCUSSION
Our study indicates the need of both cognitive tools and experiential learning modalities to foster SMM development for the delivery of optimal clinical teamwork performances. Given its scalability and practicality, we anticipate a greater role for virtual simulations to support interprofessional team training.",2019,Teamwork performance and interprofessional attitude scores of the full intervention group were significantly higher (P < 0.05) than those of the control group.,['207 health profession learners who were randomized into three groups'],"['team training program', 'didactic part, and group 3 (control group) with no intervention', 'didactic training part on cognitive tools and a virtual simulation to support clinical teamwork in interprofessional round']","['attitude scores on interprofessional teamwork', 'team performance in full scale simulation', 'interprofessional attitudes', 'Teamwork performance and interprofessional attitude scores']","[{'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",,0.0354043,Teamwork performance and interprofessional attitude scores of the full intervention group were significantly higher (P < 0.05) than those of the control group.,"[{'ForeName': 'Sok Ying', 'Initials': 'SY', 'LastName': 'Liaw', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. nurliaw@nus.edu.sg.'}, {'ForeName': 'Ling Ting', 'Initials': 'LT', 'LastName': 'Wu', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Lai Fun', 'Initials': 'LF', 'LastName': 'Wong', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Shawn Leng Hsien', 'Initials': 'SLH', 'LastName': 'Soh', 'Affiliation': 'Health and Social Sciences Cluster, Singapore Institute of Technology, Singapore, Singapore.'}, {'ForeName': 'Yeow Leng', 'Initials': 'YL', 'LastName': 'Chow', 'Affiliation': 'Alice Lee Centre for Nursing Studies, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ringsted', 'Affiliation': 'Center for Health Science Education at the Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Tang Ching', 'Initials': 'TC', 'LastName': 'Lau', 'Affiliation': 'Yong Loo Lin School Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Wee Shiong', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Yong Loo Lin School Medicine, National University of Singapore, Singapore, Singapore.'}]",Journal of general internal medicine,['10.1007/s11606-019-05320-z']
429,32162301,Long-term follow-up of the randomized trial of mesorectal excision with or without lateral lymph node dissection in rectal cancer (JCOG0212).,"BACKGROUND
Japan Clinical Oncology Group (JCOG) 0212 (ClinicalTrials.gov NCT00190541) was a non-inferiority phase III trial of patients with clinical stage II-III rectal cancer without lateral pelvic lymph node enlargement. The trial compared mesorectal excision (ME) with ME and lateral lymph node dissection (LLND), with a primary endpoint of recurrence-free survival (RFS). The planned primary analysis at 5 years failed to confirm the non-inferiority of ME alone compared with ME and LLND. The present study aimed to compare ME alone and ME with LLND using long-term follow-up data from JCOG0212.
METHODS
Patients with clinical stage II-III rectal cancer below the peritoneal reflection and no lateral pelvic lymph node enlargement were included in this study. After surgeons confirmed R0 resection by ME, patients were randomized to receive ME alone or ME with LLND. The primary endpoint was RFS.
RESULTS
A total of 701 patients from 33 institutions were assigned to ME with LLND (351) or ME alone (350) between June 2003 and August 2010. The 7-year RFS rate was 71.1 per cent for ME with LLND and 70·7 per cent for ME alone (hazard ratio (HR) 1·09, 95 per cent c.i. 0·84 to 1·42; non-inferiority P = 0·064). Subgroup analysis showed improved RFS among patients with clinical stage III disease who underwent ME with LLND compared with ME alone (HR 1·49, 1·02 to 2·17).
CONCLUSION
Long-term follow-up data did not support the non-inferiority of ME alone compared with ME and LLND. ME with LLND is recommended for patients with clinical stage III disease, whereas LLND could be omitted in those with clinical stage II tumours.",2020,Long-term follow-up data did not support the non-inferiority of ME alone compared with ME and LLND.,"['701 patients from 33 institutions', '350) between June 2003 and August 2010', 'Patients with clinical stage II-III rectal cancer below the peritoneal reflection and no lateral pelvic lymph node enlargement', 'patients with clinical stage III disease', 'patients with clinical stage III disease who underwent ME with', 'patients with clinical stage II-III rectal cancer without lateral pelvic lymph node enlargement']","['mesorectal excision (ME) with ME and lateral lymph node dissection (LLND', 'ME with LLND (351) or ME alone', 'mesorectal excision with or without lateral lymph node dissection', 'ME alone compared with ME and LLND', 'LLND', 'ME alone or ME with LLND', 'ME alone and ME with LLND']","['recurrence-free survival (RFS', 'RFS', '7-year RFS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0205571', 'cui_str': 'Clinical stage II (finding)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C1293134', 'cui_str': 'Enlargement procedure'}, {'cui': 'C0205578', 'cui_str': 'Clinical stage III (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",701.0,0.139146,Long-term follow-up data did not support the non-inferiority of ME alone compared with ME and LLND.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tsukamoto', 'Affiliation': 'Department of Colorectal Surgery, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Department of Surgery, Tochigi Cancer Centre, Tochigi, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Surgery, Yokohama City University Medical Centre, Kanagawa, Japan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mizusawa', 'Affiliation': 'Japan Clinical Oncology Group Data Centre and Operations Office, National Cancer Centre Hospital, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Shida', 'Affiliation': 'Department of Colorectal Surgery, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Colorectal Surgery Division, National Cancer Centre Hospital East, Chiba, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shiomi', 'Affiliation': 'Division of Colon and Rectal Surgery, Shizuoka Cancer Centre Hospital, Shizuoka, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Komori', 'Affiliation': 'Department of Surgery, Aichi Cancer Centre Hospital, Aichi, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Gastroenterological Surgery, Suita Municipal Hospital, Osaka International Cancer Institute, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Akazai', 'Affiliation': 'Department of Surgery, Okayama Saiseikai General Hospital, Okayama, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shiozawa', 'Affiliation': 'Department of Surgery, Kanagawa Cancer Centre, Kanagawa, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Surgery, Kyoto Medical Centre, Kyoto, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bando', 'Affiliation': 'Department of Surgery, Ishikawa Prefectural Central Hospital, Ishikawa, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsuchida', 'Affiliation': 'Department of Surgery, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Okamura', 'Affiliation': 'Department of Surgery, Suita Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Akagi', 'Affiliation': 'Department of Surgery, Kurume University, Fukuoka, Japan.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Gastrointestinal Surgery, Chiba Cancer Centre, Chiba, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Saida', 'Affiliation': 'Department of Surgery, Toho University Ohashi Medical Centre, Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Akasu', 'Affiliation': 'Hospital of the Imperial Household, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Moriya', 'Affiliation': 'Department of Surgery, Miki Hospital, Iwate, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of surgery,['10.1002/bjs.11513']
430,30604386,The Effect of Educational Intervention Based on the Theory of Planned Behavior on Mammography Screening in Iranian Women.,"Mammography is the most special screening method for early diagnosis of breast cancer. The purpose of present research is investigating the effect of educational intervention based on theory of planned behavior on mammography screening of women in Fasa city, Fars province, Iran. In this quasi-experimental study, 400 subjects (200 subjects for experimental group and 200 subjects for control group) were selected in 2017-2018. Educational intervention for the experimental group included 8 educational sessions. A questionnaire used for evaluating demographic information and constructs of theory of planned behavior (knowledge, perceived behavioral control, subjective norms, and attitude) investigated mammography performance of women before and 6 months after intervention. Data were analyzed by using SPSS 22 through chi-square test, McNemar's test, and Wilcoxon-Mann-Whitney test at significance level of P < 0.05. The average age of subjects was 45.52 ± 6.76 years in the experimental group and 45.12 ± 6.64 years in the control group. Six months after intervention, the experimental group showed significant increase in knowledge, perceived behavioral control, subjective norms, and attitude compared to the control group and 174 people (78%) of the experimental group had intention for doing mammography and 148 people (74%) of the experimental group performed mammography. Also, 6 months after educational intervention, 38 people (19%) of the control group had intention for performing mammography and 14 people (7%) of the control group performed mammography.",2020,"Six months after intervention, the experimental group showed significant increase in knowledge, perceived behavioral control, subjective norms, and attitude compared to the control group and 174 people (78%) of the experimental group had intention for doing mammography and 148 people (74%) of the experimental group performed mammography.","['400 subjects (200 subjects for experimental group and 200 subjects for control group) were selected in 2017-2018', 'The average age of subjects was 45.52\xa0±\xa06.76\xa0years in the experimental group and 45.12\xa0±', 'women in Fasa city, Fars province, Iran', 'Iranian Women']","['Educational Intervention', 'educational intervention', 'Mammography', 'Educational intervention']","['knowledge, perceived behavioral control, subjective norms, and attitude']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}]","[{'cui': 'C0024671', 'cui_str': 'Mammography'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",400.0,0.0196216,"Six months after intervention, the experimental group showed significant increase in knowledge, perceived behavioral control, subjective norms, and attitude compared to the control group and 174 people (78%) of the experimental group had intention for doing mammography and 148 people (74%) of the experimental group performed mammography.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khani Jeihooni', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa, Iran. Khani_1512@yahoo.com.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Darvishi', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa, Iran.'}, {'ForeName': 'Pooyan Afzali', 'Initials': 'PA', 'LastName': 'Harsini', 'Affiliation': 'Department of Public Health, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1460-3']
431,30604384,Evaluation of the Efficacy of the Three-Component Health Care Management Program HEWCOT in Colorectal Cancer Patients Receiving Chemotherapy.,"This study was performed to evaluate effects of education, home visits, web, and phone counseling on chemotherapy symptoms and anxiety in patients with colorectal cancer receiving chemotherapy. This pretest-posttest, quasi-experimental study was conducted in a chemotherapy unit of a hospital between February 2014 and October 2015. Due to dropouts from the study, was completed on 51 participants in the control group and 31 participants in the experimental group. The experimental group was offered a program that includes home visit, nursing education, web counseling, and tele-counseling (HEWCOT), developed by the researchers, to control symptoms and to reduce anxiety. The experimental group less frequently experienced constipation, pain, pricking and numbness in hands and feet, skin and nail problems, ocular problems, weakness, headache, mouth and throat problems, anxiety, and restlessness than the control group. The experimental group had less severe infection symptoms, hair loss, and mouth and throat problems after the interventions than the control group. In this study, the patients followed at home and provided web counseling and tele-counseling experienced less frequently chemotherapy symptoms.",2020,"The experimental group had less severe infection symptoms, hair loss, and mouth and throat problems after the interventions than the control group.","['patients with colorectal cancer receiving chemotherapy', '51 participants in the control group and 31 participants in the experimental group', 'Colorectal Cancer Patients Receiving Chemotherapy']","['education, home visits, web, and phone counseling', 'program that includes home visit, nursing education, web counseling, and tele-counseling (HEWCOT']","['severe infection symptoms, hair loss, and mouth and throat problems', 'constipation, pain, pricking and numbness in hands and feet, skin and nail problems, ocular problems, weakness, headache, mouth and throat problems, anxiety, and restlessness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013636', 'cui_str': 'Education, Nursing'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0577003', 'cui_str': 'Pharynx problem (finding)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0239832', 'cui_str': 'Numbness of hand (finding)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0574761', 'cui_str': 'Nail problem (finding)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C3714552', 'cui_str': 'Weakness - general'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0542200', 'cui_str': 'Restlessness (phenothiazine)'}]",,0.0177331,"The experimental group had less severe infection symptoms, hair loss, and mouth and throat problems after the interventions than the control group.","[{'ForeName': 'Iknur Aydin', 'Initials': 'IA', 'LastName': 'Avci', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Birsen', 'Initials': 'B', 'LastName': 'Altay', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Cavusoglu', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Cal', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey. aysecaloglu@hotmail.com.'}, {'ForeName': 'Nuran', 'Initials': 'N', 'LastName': 'Mumcu', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Dilek Celik', 'Initials': 'DC', 'LastName': 'Eren', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Oz', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Alaattin', 'Initials': 'A', 'LastName': 'Altin', 'Affiliation': 'Faculty of Health Sciences, Ondokuz Mayıs University, Samsun, Turkey.'}, {'ForeName': 'Ozden', 'Initials': 'O', 'LastName': 'Karaoglanoglu', 'Affiliation': 'Samsun Education and Research Hospital Radiation Oncology Clinic, Samsun, Turkey.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Buberci', 'Affiliation': 'Samsun Education and Research Hospital Chemotherapy Clinic, Samsun, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1461-2']
432,32096571,"Influence of an SGLT2 inhibitor, tofogliflozin, on the resting heart rate in relation to adipose tissue insulin resistance.","AIMS
To examine the effects of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, tofogliflozin, on resting heart rate by exploring baseline factors that independently influenced changes in the resting heart rate.
METHODS
Data on 419 participants in tofogliflozin phase 2/3 trials were analysed. Changes in resting heart rate from baseline to week 24 were analysed using an analysis of covariance (ANCOVA) model with groups (tofogliflozin/placebo) as a fixed effect and baseline values as covariates. The antilipolytic effect was evaluated as adipose tissue insulin resistance (Adipo-IR) and was calculated as the product of fasting insulin and free fatty acid. Multivariate analysis evaluated independent factors for changes in resting heart rate from baseline to week 24.
RESULTS
Of the participants, 58% were men, and mean age, HbA 1c , BMI and resting heart rate were 57.6 years, 65 mmol/mol (8.1%), 25.5 kg/m 2 and 66 bpm, respectively. At week 24, adjusted mean difference vs. placebo in the change from baseline was -2.3 bpm [95% confidence interval (CI) -4.6, -0.1] with tofogliflozin. Changes in resting heart rate were positively correlated with changes in Adipo-IR, whereas reductions in HbA 1c , body weight and blood pressure were similar independent of changes in resting heart among quartiles of resting heart rate change. On multivariate analysis, higher baseline resting heart rates and Adipo-IR values were significantly associated with greater reductions in resting heart rate.
CONCLUSIONS
Tofogliflozin corrected resting heart rate levels in accordance with baseline levels. Correction of high resting heart rates may be attributed to improved adipose tissue insulin resistance, leading to correction of hyperinsulinaemia.",2020,"At week 24, adjusted mean difference vs. placebo in the change from baseline was -2.3 bpm [95% confidence interval (CI) -4.6, -0.1] with tofogliflozin.","[' 58% were men, and mean age, HbA 1c , BMI and resting heart rate were 57.6 years, 65 mmol/mol (8.1%), 25.5 kg/m 2 and 66 bpm, respectively', 'Data on 419 participants in tofogliflozin phase 2/3 trials were analysed']","['Tofogliflozin', 'tofogliflozin/placebo', 'placebo', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor, tofogliflozin', 'SGLT2 inhibitor, tofogliflozin']","['antilipolytic effect', 'HbA 1c , body weight and blood pressure', 'resting heart rate', 'adipose tissue insulin resistance (Adipo-IR']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C4517663', 'cui_str': 'Twenty-five point five'}, {'cui': 'C3501434'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C3501434'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}]",419.0,0.0414319,"At week 24, adjusted mean difference vs. placebo in the change from baseline was -2.3 bpm [95% confidence interval (CI) -4.6, -0.1] with tofogliflozin.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nojima', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Clinical Data Science Department, Kowa Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ishizawa', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14279']
433,31536984,Effect of Dumbbell Exercise on Arteriovenous Fistula in Patients Undergoing Maintenance Haemodialysis: A Prospective Randomized Controlled Trial.,"BACKGROUND
Arteriovenous fistulas (AVF) have been the main vascular accesses for haemodialysis patients, but the maintenance after maturation poses serious challenges. Arm exercises promote the maturation of AVFs. However, few studies have evaluated the effect of arm exercise on matured AVF and addressed the intervention for late fistula failure.
OBJECTIVES
The study was conducted to explore the effect of dumbbell exercise on mature AVF.
METHODS
86 participants undergoing haemodialysis with AVFs were randomized into the control group and experimental group. The experimental group held 6-pound dumbbells on non-dialysis days for 3 months, while the control group squeezed rubber balls.
RESULTS
For blood flow of draining vein (DV; primary outcome), the between-group effects, interaction effect and time effect showed significant differences. A significant increase in blood flow of DV was observed in the dumbbell group at the 3rd month (mean difference, 359.50 [111.90-829.05] mL/min; p = 0.001). The difference in blood flow of AVF proximal artery, blood flow of brachial artery, the diameter of DV and the incidence of adverse events at 3 months (secondary outcomes) between the 2 groups was insignificant.
CONCLUSION
Prolonged training with arm exercises is essential for patients with AVFs though the fistula has matured. The designed dumbbell exercise is an economical, effective intervention to maintain the function of AVF, especially for patients with potential reduction of access blood flow and no percutaneous transluminal angioplasty indication.",2020,"A significant increase in blood flow of DV was observed in the dumbbell group at the 3rd month (mean difference, 359.50 [111.90-829.05] mL/min; p = 0.001).","['haemodialysis patients', 'Patients Undergoing Maintenance Haemodialysis', 'patients with potential reduction of access blood flow and no percutaneous transluminal angioplasty indication', '86 participants undergoing haemodialysis with AVFs']","['Prolonged training with arm exercises', 'dumbbell exercise', 'control group squeezed rubber balls', 'Dumbbell Exercise']","['Arteriovenous Fistula', 'blood flow of AVF proximal artery, blood flow of brachial artery, the diameter of DV and the incidence of adverse events', 'blood flow of DV']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C0035918', 'cui_str': 'Natural Rubber'}]","[{'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula (morphologic abnormality)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0449215', 'cui_str': 'aVF (body structure)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",86.0,0.037392,"A significant increase in blood flow of DV was observed in the dumbbell group at the 3rd month (mean difference, 359.50 [111.90-829.05] mL/min; p = 0.001).","[{'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Mo', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jingya', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Shuqian', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhuang', 'Affiliation': 'Department of Rehabilitation Medicine, Guangdong Second Traditional Chinese Medicine Hospital, Guangzhou, China.'}, {'ForeName': 'Yuanhan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Shuangxin', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""Division of Nephrology, Guangdong Provincial People's Hospital/Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'School of Nursing, Southern Medical University, Guangzhou, China, fx-rena@163.com.'}]",Blood purification,['10.1159/000502332']
434,31851982,Effect of Hemodiafiltration on Self-Reported Sleep Duration: Results from a Randomized Controlled Trial.,"INTRODUCTION
Dialysis patients suffer from poor sleep duration and quality. We examined the self-reported sleep duration in patients randomized to either high-volume hemodiafiltration (HDF) or high flux hemodialysis (HD).
METHODS
Patients from 13 Brazilian dialysis clinics were enrolled in the HDFIT randomized controlled trial (RCT) investigating the impact of HDF on physical activity and self-reported outcomes. Self-reported sleep duration was taken from patient diaries recording sleep start and end time over a week during baseline, months 3 and 6, respectively. Sleep duration was analyzed by shift and nights relative to dialysis.
RESULTS
The HDFIT study enrolled 197 patients; sleep data were available in 173 patients (87 HD; 86 HDF). Patients' age was 53 ± 15 years, 57% were white, 72% were male, 34% had diabetes, Kt/V was 1.54 ± 0.40, and albumin 3.97 ± 0.36 g/dL. Most patients reported sleeping 510-530 min/night. At 3 months, HDF patients slept 513 ± 71 min/night, HD patients 518 ± 76 min/night. At 6 months, HDF patients slept 532 ± 74 min/night, HD patients 519 ± 80 min/night. At baseline, 1st shift patients slept 406 ± 86 min the night before HD, 534 ± 64 min the night after HD, and 496 ± 99 min the night between 2 non-HD days. Compared to patients in the 2nd and 3rd shifts, patients dialyzed in the 1st shift slept less in the night before dialysis. Similar patterns were seen after 3 and 6 months.
CONCLUSION
In our RCT, the dialysis modality (HDF vs. HD) had no effect on self-reported sleep duration. In both groups, dialysis in the 1st shift adversely affected self reported sleep duration.",2020,"In our RCT, the dialysis modality (HDF vs. HD) had no effect on self-reported sleep duration.","['197 patients; sleep data were available in 173 patients (87 HD; 86 HDF', ""Patients' age was 53 ± 15 years, 57% were white, 72% were male, 34% had diabetes, Kt/V was 1.54 ± 0.40, and albumin 3.97 ± 0.36 g/dL. Most patients reported sleeping 510-530 min/night"", 'Patients from 13 Brazilian dialysis clinics']","['Hemodiafiltration', 'high-volume hemodiafiltration (HDF) or high flux hemodialysis (HD']","['Self-Reported Sleep Duration', 'Sleep duration', 'Self-reported sleep duration', 'self-reported sleep duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C4517452', 'cui_str': '0.36'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4517800', 'cui_str': '510 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",197.0,0.0204139,"In our RCT, the dialysis modality (HDF vs. HD) had no effect on self-reported sleep duration.","[{'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil, maggie.han@rriny.com.'}, {'ForeName': 'Murilo', 'Initials': 'M', 'LastName': 'Guedes', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.'}, {'ForeName': 'Jochen G', 'Initials': 'JG', 'LastName': 'Raimann', 'Affiliation': 'Renal Research Institute, Research Department, New York, New York, USA.'}, {'ForeName': 'Ana Beatriz', 'Initials': 'AB', 'LastName': 'Lesqueves Barra', 'Affiliation': 'Medical Office, Fresenius Medical Care, São Paulo, Brazil.'}, {'ForeName': 'Maria Eugênia Fernandes', 'Initials': 'MEF', 'LastName': 'Canziani', 'Affiliation': 'Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Américo Lourenço', 'Initials': 'AL', 'LastName': 'Cuvello Neto', 'Affiliation': 'Department of Nephrology, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Poli-de-Figueiredo', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kotanko', 'Affiliation': 'Renal Research Institute, Research Department, New York, New York, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pecoits-Filho', 'Affiliation': 'School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Brazil.'}]",Blood purification,['10.1159/000504242']
435,32100297,Telemedicine in postoperative follow-up of STOMa PAtients: a randomized clinical trial (the STOMPA trial).,"BACKGROUND
A stoma has severe impact on the patient's quality of life (QoL). Postoperative home community follow-up by teleconsultation (TC) and stoma nurses may reduce the burden of travel and improve QoL.
METHODS
A university hospital and five district medical centres participated. Patients with a stoma were randomized to follow-up by either TC (intervention) or hospital (control). Stoma nurses performed the clinical examination at the TC studio, aided remotely by hospital nurses and surgeons. The primary endpoint was the EQ-5D™ index score; secondary endpoints were the Stoma Quality-of-Life Scale, the OutPatient Experiences Questionnaire, and use of hospital resources.
RESULTS
A total of 110 patients were randomized to hospital (58 patients) or TC (52) follow-up; 64 patients (hospital 38, TC 26) were followed for more than 12 months and 246 consultations (hospital 151, TC 95) were performed. There were no differences in QoL: EQ-5D™ index score (P = 0·301) and EQ-5D™ visual analogue scale (VAS) score (P = 0·775); Work/Social Function (P = 0·822); Sexuality/Body Image (P = 0·253) and Stoma Function (P = 0·074). Hospital follow-up performed better for organization of care (staff collaboration, P = 0·004; met same persons, P = 0·003) and communication (surgeon understandable, P < 0·001; surgeon caring P = 0·003). TC did not increase the number of hospital consultations (P = 0·684) and reduced the number of journeys of more than 8 h (P = 0·007).
CONCLUSION
Telemedicine follow-up by stoma nurses did not improve the QoL of patients, but decreased the readmission rate and burden of travel. Registration number NCT01600508 ( https://www.clinicaltrials.gov).",2020,There were no differences in QoL: EQ-5D™ index score (P = 0·301) and EQ-5D™ visual analogue scale (VAS) score (P = 0·775); Work/Social Function (P = 0·822); Sexuality/Body Image (P = 0·253) and Stoma Function (P = 0·074).,"['A university hospital and five district medical centres participated', 'Patients with a stoma', '110 patients were randomized to hospital (58 patients) or TC (52) follow-up; 64 patients (hospital 38, TC 26) were followed for more than 12\u2009months and 246 consultations (hospital 151, TC 95) were performed']","['Postoperative home community follow-up by teleconsultation (TC) and stoma nurses', 'Telemedicine', 'TC (intervention) or hospital (control', 'TC']","['Stoma Quality-of-Life Scale, the OutPatient Experiences Questionnaire, and use of hospital resources', 'number of hospital consultations', 'number of journeys', 'EQ-5D™ index score', 'readmission rate and burden of travel', 'QoL: EQ-5D™ index score (P =\u20090·301) and EQ-5D™ visual analogue scale (VAS) score (P =\u20090·775); Work/Social Function (P =\u20090·822); Sexuality/Body Image']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0282675', 'cui_str': 'Teleconsultation'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036915', 'cui_str': 'Sexuality'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]",110.0,0.0926676,There were no differences in QoL: EQ-5D™ index score (P = 0·301) and EQ-5D™ visual analogue scale (VAS) score (P = 0·775); Work/Social Function (P = 0·822); Sexuality/Body Image (P = 0·253) and Stoma Function (P = 0·074).,"[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Augestad', 'Affiliation': 'Department of Surgery, Sandnessjøen Hospital, University Hospital of North Norway, Sandnessjøen, Norway.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Sneve', 'Affiliation': ""Division of Surgery and Women's Health, University Hospital of North Norway, Tromsø, Norway.""}, {'ForeName': 'R-O', 'Initials': 'RO', 'LastName': 'Lindsetmo', 'Affiliation': ""Division of Surgery and Women's Health, University Hospital of North Norway, Tromsø, Norway.""}]",The British journal of surgery,['10.1002/bjs.11491']
436,31622137,"Impact of the Terms "" Regular "" or "" Pasable "" as Spanish Translation for ""Fair"" of the Self-Rated Health Question Among US Latinos: A Randomized Experiment.","Objectives. To examine measurement comparability of a Spanish version of self-rated health (SRH) with pasable as an alternative to regular for the response category ""fair"" in the English version. Methods. We translated ""fair"" into 2 Spanish versions: regular and pasable . We implemented a split-half experiment in 3 surveys independently conducted from October 2015 to January 2016, from April to November 2016, and from August to November 2017. Within each survey, we randomly assigned Spanish-interviewed Latino respondents to 1 of the 2 SRH versions. The total sample included 3261 Latino and 738 non-Latino White adults in the United States. Results. Spanish-interviewed Latinos reported substantively more favorable health on SRH with pasable than with regular . When pasable instead of regular was used for SRH, we observed a larger difference between respondents reporting positive versus negative SRH on objective health measures, including the frequency of doctor's visits. Furthermore, when we accounted for correlates of health, Latino-White disparities were attenuated with pasable . Conclusions. We recommend using pasable instead of regular for SRH Spanish translations to improve measurement equivalence in cross-lingual and cross-cultural research.",2019,"When pasable instead of regular was used for SRH, we observed a larger difference between respondents reporting positive versus negative SRH on objective health measures, including the frequency of doctor's visits.","['3 surveys independently conducted from October 2015 to January 2016, from April to November 2016, and from August to November 2017', 'The total sample included 3261 Latino and 738 non-Latino White adults in the United States']",['Spanish version of self-rated health (SRH) with pasable'],[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],3261.0,0.0365853,"When pasable instead of regular was used for SRH, we observed a larger difference between respondents reporting positive versus negative SRH on objective health measures, including the frequency of doctor's visits.","[{'ForeName': 'Sunghee', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Sunghee Lee and Fernanda Alvarado-Leiton are with the Institute for Social Research, University of Michigan, Ann Arbor. Elizabeth Vasquez is with the School of Public Health, University at Albany, State University of New York, Albany. Rachel E. Davis is with the School of Public Health, University of South Carolina, Columbia.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Alvarado-Leiton', 'Affiliation': 'Sunghee Lee and Fernanda Alvarado-Leiton are with the Institute for Social Research, University of Michigan, Ann Arbor. Elizabeth Vasquez is with the School of Public Health, University at Albany, State University of New York, Albany. Rachel E. Davis is with the School of Public Health, University of South Carolina, Columbia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vasquez', 'Affiliation': 'Sunghee Lee and Fernanda Alvarado-Leiton are with the Institute for Social Research, University of Michigan, Ann Arbor. Elizabeth Vasquez is with the School of Public Health, University at Albany, State University of New York, Albany. Rachel E. Davis is with the School of Public Health, University of South Carolina, Columbia.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Davis', 'Affiliation': 'Sunghee Lee and Fernanda Alvarado-Leiton are with the Institute for Social Research, University of Michigan, Ann Arbor. Elizabeth Vasquez is with the School of Public Health, University at Albany, State University of New York, Albany. Rachel E. Davis is with the School of Public Health, University of South Carolina, Columbia.'}]",American journal of public health,['10.2105/AJPH.2019.305341']
437,31755550,Longer Term Effects of Diet and Exercise on Neurocognition: 1-Year Follow-up of the ENLIGHTEN Trial.,"OBJECTIVES
To evaluate the longer term changes in executive functioning among participants with cardiovascular disease (CVD) risk factors and cognitive impairments with no dementia (CIND) randomized to a diet and exercise intervention.
DESIGN
A 2 (Exercise) × 2 (Dietary Approaches to Stop Hypertension [DASH] eating plan) factorial randomized clinical trial.
SETTING
Academic tertiary care medical center.
PARTICIPANTS
Volunteer sample of 160 older sedentary adults with CIND and at least one additional CVD risk factor enrolled in the ENLIGHTEN trial between December 2011 and March 2016.
INTERVENTIONS
Six months of aerobic exercise (AE), DASH diet counseling, combined AE + DASH, or health education (HE) controls.
MEASUREMENTS
Neurocognitive battery recommended by the Neuropsychological Working Group for Vascular Cognitive Disorders including measures of executive function, memory, and language/verbal fluency. Secondary outcomes included the Clinical Dementia Rating-Sum of Boxes (CDR-SB), Six-Minute Walk Distance (6MWD), and CVD risk including blood pressure, body weight, and CVD medication burden.
RESULTS
Despite discontinuation of lifestyle changes, participants in the exercise groups retained better executive function 1 year post-intervention (P = .041) compared with non-exercise groups, with a similar, albeit weaker, pattern in the DASH groups (P = .054), without variation over time (P's > .867). Participants in the exercise groups also achieved greater sustained improvements in 6MWD compared with non-Exercise participants (P < .001). Participants in the DASH groups exhibited lower CVD risk relative to non-DASH participants (P = .032); no differences in CVD risk were observed for participants in the Exercise groups compared with non-Exercise groups (P = .711). In post hoc analyses, the AE + DASH group had better performance on executive functioning (P < .001) and CDR-SB (P = .011) compared with HE controls.
CONCLUSION
For participants with CIND and CVD risk factors, exercise for 6 months promoted better executive functioning compared with non-exercisers through 1-year post-intervention, although its clinical significance is uncertain. J Am Geriatr Soc 68:559-568, 2020.",2020,"In post hoc analyses, the AE + DASH group had better performance on executive functioning (P < .001) and CDR-SB (P =","['participants with CIND and CVD risk factors', 'Volunteer sample of 160 older sedentary adults with CIND and at least one additional CVD risk factor enrolled in the ENLIGHTEN trial between December 2011 and March 2016', 'participants with cardiovascular disease (CVD) risk factors and cognitive impairments with no dementia (CIND', 'Academic tertiary care medical center']","['2 (Exercise) ×\u20092 (Dietary Approaches', 'aerobic exercise (AE), DASH diet counseling, combined AE\u2009+\u2009DASH, or health education (HE) controls', 'diet and exercise intervention', 'Diet and Exercise']","['Clinical Dementia Rating-Sum of Boxes (CDR-SB), Six-Minute Walk Distance (6MWD), and CVD risk including blood pressure, body weight, and CVD medication burden', 'CVD risk relative', 'executive functioning', '6MWD', 'Vascular Cognitive Disorders including measures of executive function, memory, and language/verbal fluency', 'executive function', 'CDR-SB', 'Neurocognition', 'CVD risk']","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0018701'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0451074', 'cui_str': 'Dementia Rating Scale'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0055351', 'cui_str': 'Chlordecone reductase'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0009241', 'cui_str': 'Cognition Disorders'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]",160.0,0.102264,"In post hoc analyses, the AE + DASH group had better performance on executive functioning (P < .001) and CDR-SB (P =","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Blumenthal', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mabe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hinderliter', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Welsh-Bohmer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Browndyke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'P Murali', 'Initials': 'PM', 'LastName': 'Doraiswamy', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Burke', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sherwood', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16252']
438,31414370,"The Effect of Health Education Given to Syrian Refugee Women in Their Own Language on Awareness of Breast and Cervical Cancer, in Turkey: a Randomized Controlled Trial.","In general, refugees have an increased cancer burden because of living in difficult conditions and having low income. Refugee women may have difficulty in accessing healthcare services because of the fear of uncertainty, security concerns, language barriers, cultural differences, and economic problems. For this reason, it is thought that health education given to Syrian refugee women by overcoming the language problem (given in their own language-Arabic) increases the awareness of breast and cervical cancer. The aim of this study is to evaluate the effect of health education given to refugee women in their own language on the awareness of breast and cervical cancer. This is a randomized controlled trial with one control and one intervention group. The research sample consisted of 60 Syrian women (30 experiments, 30 controls), at least 18 years old, married, and literate women who were refugees in Hatay/Turkey. The research data were collected via the questionnaire form developed by the researchers. At the beginning of the study, there was no statistically significant difference in terms of age, education, economic status, gravida, and parity among the women in the experimental and control groups (p > 0.05). There was no statistically significant difference between the pre-test mean scores of the experimental and control groups (p > 0.05). However, there was a statistically significant difference between the post-test mean scores of the experimental and control groups (p < 0.005). In this study, it was determined that health education given to refugee women in their own language had a significant effect on breast and cervical cancer awareness. The attitudes and motivations are shaped, not only by personal information but also by the cultural changes within the community.",2020,There was no statistically significant difference between the pre-test mean scores of the experimental and control groups (p > 0.05).,"['Syrian Refugee Women in Their Own Language on Awareness of Breast and Cervical Cancer, in Turkey', 'refugee women in their own language on the awareness of breast and cervical cancer', '60 Syrian women (30 experiments, 30 controls), at least 18\xa0years old, married, and literate women who were refugees in Hatay/Turkey']","['Health Education', 'health education']","['age, education, economic status, gravida, and parity', 'breast and cervical cancer awareness']","[{'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[{'cui': 'C0018701'}],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0337781', 'cui_str': 'Economic Status'}, {'cui': 'C0600457', 'cui_str': 'Gravidity'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",,0.0337796,There was no statistically significant difference between the pre-test mean scores of the experimental and control groups (p > 0.05).,"[{'ForeName': 'Rabiye', 'Initials': 'R', 'LastName': 'Erenoğlu', 'Affiliation': 'Nursing Department, Gyneacology and Obstetric Nursıng Department, Hatay Healthy High School, Mustafa Kemal University, Tayfur Sökmen Campus Alahan, 31060, Antakya, Hatay, Turkey. r_gungor80@hotmail.com.'}, {'ForeName': 'Şengül', 'Initials': 'Ş', 'LastName': 'Yaman Sözbir', 'Affiliation': 'Nursing Department, Gynecology and Obstetric Nursing Department, Faculty of Health Sciences, Gazi University, Ankara, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-019-01604-4']
439,31896118,"Effects of intranasal insulin as an enhancer of fear extinction: a randomized, double-blind, placebo-controlled experimental study.","Fear-extinction based psychotherapy (exposure) is the most effective method for treating anxiety disorders. Notwithstanding, since some patients show impairments in the unlearning of fear and insufficient fear remission, there is a growing interest in using cognitive enhancers as adjuvants to exposure. As insulin plays a critical role in stress processes and acts as a memory enhancer, this study aimed to assess the capacity of intranasal insulin to augment fear extinction. A double-blind, placebo-controlled differential fear-conditioning paradigm was conducted in 123 healthy participants (63 females). Pictures of faces with neutral expressions were used as conditioned stimuli and electric shocks as unconditioned stimuli. The paradigm consisted of four phases presented on three consecutive days: acquisition (day 1), extinction (day 2), reinstatement and re-extinction (day 3). A single intranasal dose of insulin (160 IU) or placebo was applied on day 2, 45 min before fear extinction. Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings were assessed. During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group. Furthermore, a sex-specific effect was found for SCR, with women in the insulin group showing a greater decrease of differential SCR both at early extinction and at late re-extinction. Our results provide first evidence that intranasal insulin facilitates fear extinction processes and is therefore a promising adjuvant for extinction-based therapies in anxiety and related disorders. Sex-specific effects should be taken into consideration in future studies.",2020,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.",['123 healthy participants (63 females'],"['placebo-controlled differential fear-conditioning paradigm', 'insulin', 'intranasal insulin', 'Fear-extinction based psychotherapy (exposure', 'placebo']","['differential FPS', 'Skin conductance response (SCR), fear-potentiated startle (FPS) and expectancy ratings', 'enhancer of fear extinction', 'differential SCR']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",123.0,0.138692,"During extinction, the insulin group (independent of sex) showed a significantly stronger decrease in differential FPS in comparison with the placebo group.","[{'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Ferreira de Sá', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany. diana.ferreira@uni-saarland.de.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Römer', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexandra H', 'Initials': 'AH', 'LastName': 'Brückner', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Issler', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hauck', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Michael', 'Affiliation': 'Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Saarbrücken, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0593-3']
440,31779928,Impact of Age on Comorbidities and Outcomes in Heart Failure With Reduced Ejection Fraction.,"OBJECTIVES
This study sought to determine whether age modifies the impact of key comorbidities on clinical outcomes for patients with heart failure with reduced ejection fraction (HFrEF).
BACKGROUND
Comorbidities impact outcomes in HFrEF. However, the effect of age on the impact of comorbidities on prognosis is not clearly understood.
METHODS
Cox proportional hazards models were used assessed interactions between age and comorbidities on the primary composite endpoint (all-cause mortality or hospitalization) and secondary endpoints in the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) multicenter trial of 2,331 patients with HFrEF.
RESULTS
Age did not significantly modify the effect of any comorbidity on the primary endpoint. However, age significantly modified the effect of body mass index (BMI) on all-cause mortality (interaction p = 0.02). Among patients ≥70 years of age, there was a U-shaped relationship between BMI and 1-year mortality, where BMI of 20 kg/m 2 corresponded to 17.6%; a BMI of 30 kg/m 2 corresponded to 7.0%; and a BMI of 40 kg/m 2 corresponded to 11%. For patients <60 years of age, mortality increased nonsignificantly from 3.2% to 3.7% with increasing BMI. Age also modified the effect of depressive symptoms on all-cause mortality (interaction p = 0.03). Among patients ≥70 years of age, a 1-year mortality rate significantly increased from 7.8% for a Beck Depression Inventory (BDI) score of 5% to 15.6% for BDI of 20. For patients <60 years of age, mortality was nonsignificantly related to BDI. Cumulative comorbidity scores were stronger predictors than age for mortality/hospitalization.
CONCLUSIONS
In chronic HFrEF, age markedly altered the impact of BMI and depressive symptoms on all-cause mortality, with much higher risk in older patients, but was not as strong a predictor of mortality/hospitalizations as cumulative comorbidity score. (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training [HF-ACTION]; NCT00047437).",2019,"Among patients ≥70 years of age, a 1-year mortality rate significantly increased from 7.8% for a Beck Depression Inventory (BDI) score of 5% to 15.6% for BDI of 20.","['patients with heart failure with reduced ejection fraction (HFrEF', 'Heart\xa0Failure', 'Heart Failure', '2,331 patients with HFrEF']",['Exercise Training'],"['mortality', 'Beck Depression Inventory (BDI) score', 'Cumulative comorbidity scores', 'BMI and 1-year mortality', 'body mass index (BMI', '1-year mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score (observable entity)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",2331.0,0.137696,"Among patients ≥70 years of age, a 1-year mortality rate significantly increased from 7.8% for a Beck Depression Inventory (BDI) score of 5% to 15.6% for BDI of 20.","[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Regan', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina. Electronic address: jessica.a.regan@duke.edu.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Department of Internal Medicine, Section on Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Jerome L', 'Initials': 'JL', 'LastName': 'Fleg', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Forman', 'Affiliation': 'Department of Medicine, University of Pittsburgh and Veterans Affairs Pittsburgh Healthcare System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Department of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kishan', 'Initials': 'K', 'LastName': 'Parikh', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Department of Medicine, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.09.004']
441,31370913,Dysregulated Irritability as a Window on Young Children's Psychiatric Risk: Transdiagnostic Effects via the Family Check-Up.,"Building on prior work using Tom Dishion's Family Check-Up, the current article examined intervention effects on dysregulated irritability in early childhood. Dysregulated irritability, defined as reactive and intense response to frustration, and prolonged angry mood, is an ideal marker of neurodevelopmental vulnerability to later psychopathology because it is a transdiagnostic indicator of decrements in self-regulation that are measurable in the first years of life that have lifelong implications for health and disease. This study is perhaps the first randomized trial to examine the direct effects of an evidence- and family-based intervention, the Family Check-Up (FCU), on irritability in early childhood and the effects of reductions in irritability on later risk of child internalizing and externalizing symptomatology. Data from the geographically and sociodemographically diverse multisite Early Steps randomized prevention trial were used. Path modeling revealed intervention effects on irritability at age 4, which predicted lower externalizing and internalizing symptoms at age 10.5. Results indicate that family-based programs initiated in early childhood can reduce early childhood irritability and later risk for psychopathology. This holds promise for earlier identification and prevention approaches that target transdiagnostic pathways. Implications for future basic and prevention research are discussed.",2019,Results indicate that family-based programs initiated in early childhood can reduce early childhood irritability and later risk for psychopathology.,"[""Young Children's Psychiatric Risk"", 'early childhood']","['evidence- and family-based intervention, the Family Check-Up (FCU']","['Dysregulated Irritability', 'Dysregulated irritability', 'early childhood irritability and later risk for psychopathology']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",,0.0173004,Results indicate that family-based programs initiated in early childhood can reduce early childhood irritability and later risk for psychopathology.,"[{'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology for Drug Abuse and HIV, Department of Psychiatry and Behavioral Sciences, Feinberg School of Medicine & Institute for Innovations in Developmental Sciences, Northwestern University.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Wakschlag', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine & Institute for Innovations in Developmental Sciences, Northwestern University.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Krogh-Jespersen', 'Affiliation': 'Department of Medical Social Sciences, Feinberg School of Medicine & Institute for Innovations in Developmental Sciences, Northwestern University.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Walkup', 'Affiliation': ""Department of Psychiatry and Behavioral Sciences, Division of Child & Adolescent Psychiatry, Feinberg School of Medicine, Institute for Innovations in Developmental Sciences, Northwestern University, & Ann & Robert H. Lurie Children's Hospital.""}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'REACH Institute, Department of Psychology, Arizona State University & Oregon Research Institute.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}]",Development and psychopathology,['10.1017/S0954579419000816']
442,30772827,Adolescent males' responses to blu's fake warnings.,"OBJECTIVE
Blu's 'Something Better' advertising campaign ran in popular print magazines in 2017. The campaign included advertisements with fake warnings conveying positive messages, which mimicked the Food and Drug Administration (FDA)'s warning requirements for electronic cigarette (e-cigarette) advertisements that took effect in 2018. We report adolescent males' recall of these fake warnings and how exposure to fake warnings affected recall of other advertisement components, including the actual warning or health risks, brand and product.
METHODS
Ohio males ages 12-19 years (N = 775; 73.8 % white non-Hispanic) were randomly assigned to view an e-cigarette advertisement with or without a fake warning. Afterward, they were asked what they remembered most about the advertisement. Responses were qualitatively coded. Statistical analyses included survey-weighted descriptive statistics and logistic regression.
RESULTS
Of participants who viewed an e-cigarette advertisement with a fake warning, 27.0 % reported the fake warning was what they remembered most, and 18.8 % repeated the fake warning message. Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements.
CONCLUSIONS
Adolescents viewing an advertisement with a fake warning were less likely to recall the advertisement's actual warning or health risks. Although e-cigarette advertisements now carry large FDA-mandated warnings, this tactic could be used for cigarette advertisements that continue to carry small warnings in the USA. Findings underscore the necessity of tobacco advertisement surveillance and study of advertisements' effects on adolescents.",2019,"Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements.
","['adolescents', 'Ohio males ages 12-19 years (N = 775; 73.8 % white non-Hispanic']",['view an e-cigarette advertisement with or without a fake warning'],"['actual warning or health risks', 'fake warning']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517874', 'cui_str': '775'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0241441,"Participants viewing advertisements with a fake warning had lower odds of recalling the actual warning or health risks (OR = 0.29; 95% CI: 0.11 to 0.77) or brand (OR = 0.43; 95% CI: 0.22 to 0.85), compared with participants viewing other e-cigarette advertisements.
","[{'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Keller-Hamilton', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio, USA keller-hamilton.1@osu.edu.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Roberts', 'Affiliation': 'Division of Health Behavior and Health Promotion, College of Public Health, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Slater', 'Affiliation': 'School of Communication, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Berman', 'Affiliation': 'Division of Health Services Management and Policy, College of Public Health, The Ohio State University, Columbus, Ohio, United States.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Ferketich', 'Affiliation': 'Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054805']
443,31618073,Hop-Stabilization Training and Landing Biomechanics in Athletes With Chronic Ankle Instability: A Randomized Controlled Trial.,"CONTEXT
Hopping exercises are recommended as a functional training tool to prevent lower limb injury, but their effects on lower extremity biomechanics in those with chronic ankle instability (CAI) are unclear.
OBJECTIVE
To determine if jump-landing biomechanics change after a hop-stabilization intervention.
DESIGN
Randomized controlled clinical trial.
SETTING
Research laboratory.
PATIENTS OR OTHER PARTICIPANTS
Twenty-eight male collegiate basketball players with CAI were divided into 2 groups: hop-training group (age = 22.78 ± 3.09 years, mass = 82.59 ± 9.51 kg, height = 187.96 ± 7.93 cm) and control group (age = 22.57 ± 2.76 years, mass = 78.35 ± 7.02 kg, height = 185.69 ± 7.28 cm).
INTERVENTION(S)
A 6-week supervised hop-stabilization training program that consisted of 18 training sessions.
MAIN OUTCOME MEASURE(S)
Lower extremity kinetics and kinematics during a jump-landing task and self-reported function were assessed before and after the 6-week training program.
RESULTS
The hop-stabilization program resulted in improved self-reported function ( P < .05), larger sagittal-plane hip- and knee-flexion angles, and greater ankle dorsiflexion ( P < .05) relative to the control group. Reduced frontal-plane joint angles at the hip, knee, and ankle as well as decreased ground reaction forces and a longer time to peak ground reaction forces were observed in the hopping group compared with the control group after the intervention ( P < .05).
CONCLUSIONS
The 6-week hop-stabilization training program altered jump-landing biomechanics in male collegiate basketball players with CAI. These results may provide a potential mechanistic explanation for improvements in patient-reported outcomes and reductions in injury risk after ankle-sprain rehabilitation programs that incorporate hop-stabilization exercises.",2019,"The hop-stabilization program resulted in improved self-reported function ( P < .05), larger sagittal-plane hip- and knee-flexion angles, and greater ankle dorsiflexion ( P < .05) relative to the control group.","['Twenty-eight male collegiate basketball players with CAI were divided into 2 groups: hop-training group (age = 22.78 ± 3.09 years, mass = 82.59 ± 9.51 kg, height = 187.96 ± 7.93 cm) and control group (age = 22.57 ± 2.76 years, mass = 78.35 ± 7.02 kg, height = 185.69 ± 7.28 cm', 'male collegiate basketball players with CAI', 'Athletes With Chronic Ankle Instability']","['Hop Stabilization Training and Landing Biomechanics', '6-week hop-stabilization training program altered jump-landing biomechanics']","['Reduced frontal-plane joint angles', 'extremity kinetics and kinematics during a jump-landing task and self-reported function', 'larger sagittal-plane hip- and knee-flexion angles, and greater ankle dorsiflexion', 'ground reaction forces and a longer time to peak ground reaction forces', 'self-reported function']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}]","[{'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4551585', 'cui_str': 'Frontal plane'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]",28.0,0.0277961,"The hop-stabilization program resulted in improved self-reported function ( P < .05), larger sagittal-plane hip- and knee-flexion angles, and greater ankle dorsiflexion ( P < .05) relative to the control group.","[{'ForeName': 'Mohammad Karimizadeh', 'Initials': 'MK', 'LastName': 'Ardakani', 'Affiliation': 'Department of Health and Sport Medicine, Faculty of Physical Education and Sport Sciences, University of Tehran, Iran.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Wikstrom', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Minoonejad', 'Affiliation': 'Department of Health and Sport Medicine, Faculty of Physical Education and Sport Sciences, University of Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rajabi', 'Affiliation': 'Department of Health and Sport Medicine, Faculty of Physical Education and Sport Sciences, University of Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sharifnezhad', 'Affiliation': 'Sport Science Research Institute, Tehran, Iran.'}]",Journal of athletic training,['10.4085/1062-6050-550-17']
444,31622155,"Disseminating Evidence-Based Interventions in Small, Low-Wage Worksites: A Randomized Controlled Trial in King County, Washington (2014-2017).","Objectives. To determine whether (1) participating in HealthLinks , and (2) adding wellness committees to HealthLinks increases worksites' evidence-based intervention (EBI) implementation. Methods. We developed HealthLinks to disseminate EBIs to small, low-wage worksites. From 2014 to 2017, we conducted a site-randomized trial in King County, Washington, with 68 small worksites (20-200 employees). We assigned worksites to 1 of 3 arms: HealthLinks , HealthLinks plus wellness committee ( HealthLinks+ ), or delayed control. At baseline, 15 months, and 24 months, we assessed worksites' EBI implementation on a 0% to 100% scale and employees' perceived support for their health behaviors. Results. Postintervention EBI scores in both intervention arms ( HealthLinks and HealthLinks+ ) were significantly higher than in the control arm at 15 months (51%, 51%, and 23%, respectively) and at 24 months (33%, 37%, and 24%, respectively; P < .001). Employees in the intervention arms perceived greater support for their health at 15 and 24 months than did employees in control worksites. Conclusions. HealthLinks is an effective strategy for disseminating EBIs to small worksites in low-wage industries. Public Health Implications. Future research should focus on scaling up HealthLinks , improving EBI maintenance, and measuring impact of these on health behavior.",2019,Employees in the intervention arms perceived greater support for their health at 15 and 24 months than did employees in control worksites.,"['King County, Washington (2014-2017', 'Small, Low-Wage Worksites', 'From 2014 to 2017, we conducted a site-randomized trial in King County, Washington, with 68 small worksites (20-200 employees']","[""wellness committees to HealthLinks increases worksites' evidence-based intervention (EBI) implementation"", 'HealthLinks , HealthLinks plus wellness committee ( HealthLinks+ ), or delayed control']","[""worksites' EBI implementation"", 'Postintervention EBI scores']","[{'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0059818', 'cui_str': 'isothiocyanic acid ethylene ester'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",200.0,0.0776576,Employees in the intervention arms perceived greater support for their health at 15 and 24 months than did employees in control worksites.,"[{'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hammerback', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Marlana J', 'Initials': 'MJ', 'LastName': 'Kohn', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Kava', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Kwun C', 'Initials': 'KC', 'LastName': 'Gary Chan', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Parrish', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Mayotte', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Shirley A', 'Initials': 'SA', 'LastName': 'Beresford', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': 'Peggy A. Hannon, Kristen Hammerback, Marlana J. Kohn, Christine M. Kava, Amanda T. Parrish, Claire Allen, Caitlin Mayotte, and Jeffrey R. Harris are with the Department of Health Services, University of Washington, Seattle. Kwun C. Gary Chan is with the Department of Biostatistics, University of Washington, Seattle. Christian D. Helfrich is with VA Puget Sound Health Care System, Seattle, WA. Shirley A. Beresford is with the Department of Epidemiology, University of Washington, Seattle.'}]",American journal of public health,['10.2105/AJPH.2019.305313']
445,30563365,Dosage of pain rehabilitation programmes for patients with chronic musculoskeletal pain: a non-inferiority randomised controlled trial.,"Purpose: To analyse the effects of interdisciplinary pain rehabilitation programmes with different dosages; care as usual versus short form. Methods: A single blinded, two armed, randomised controlled trial, with non-inferiority design was performed. All patients with chronic musculoskeletal pain referred to an outpatient multidisciplinary pain rehabilitation programme were eligible for this study. Only dosage differed, content was similar. The difference on Pain Disability Index was the primary outcome measure. Four points difference on Pain Disability Index was applied as a non-inferiority margin. Treatment effects within groups were expressed in standardised mean difference and effect sizes were calculated between the groups. Results: Because care as usual was frequently extended, the difference in dosage between groups was limited. The study was stopped prematurely because of an a-priori stopping rule. Interim analyses are presented. Both groups (care as usual n = 58, short form n = 54) improved significantly (mean Pain Disability Index change care as usual: -10.8; short form: -8.3). Mean difference between groups was 2.5 points (95% confidence interval was -2.2 to 7.3). Effect size between groups was 0.2. Conclusions: The 95% confidence interval for the difference in mean pain disability reduction exceeded the upper limit of the non-inferiority margin. The results of the primary analyses of this trial are, therefore, inconclusive. Ancillary analyses revealed that programme dosage was not associated with differences in the disability outcomes. Implications for rehabilitationOptimum dosage of interdisciplinary pain rehabilitation programs is unknown and scarcely studied. This study is the first to analyse dosage as primary aim.Although results are inconclusive, they also suggest that differences in dosage may not automatically lead to differences in effects.Further research is needed to analyse what dosage works for whom; to detect optimum effective and cost-effective dosage of pain rehabilitation programmes.",2020,The 95% confidence interval for the difference in mean pain disability reduction exceeded the upper limit of the non-inferiority margin.,"['patients with chronic musculoskeletal pain', 'All patients with chronic musculoskeletal pain referred to an outpatient multidisciplinary pain rehabilitation programme were eligible for this study']","['pain rehabilitation programmes', 'interdisciplinary pain rehabilitation programmes']","['mean pain disability reduction', 'disability outcomes', 'Pain Disability Index change care', 'Pain Disability Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0458264', 'cui_str': 'Pain rehabilitation (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0458264', 'cui_str': 'Pain rehabilitation (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.165719,The 95% confidence interval for the difference in mean pain disability reduction exceeded the upper limit of the non-inferiority margin.,"[{'ForeName': 'Michiel F', 'Initials': 'MF', 'LastName': 'Reneman', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Franka P C', 'Initials': 'FPC', 'LastName': 'Waterschoot', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Johannes G M', 'Initials': 'JGM', 'LastName': 'Burgerhof', 'Affiliation': 'Department of Epidemiology, University Medical Centre Groningen, University of Groningen, The Netherlands.'}, {'ForeName': 'Jan H B', 'Initials': 'JHB', 'LastName': 'Geertzen', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Henrica R', 'Initials': 'HR', 'LastName': 'Schiphorst Preuper', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen, The Netherlands.'}, {'ForeName': 'Pieter U', 'Initials': 'PU', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Rehabilitation Medicine, Center for Rehabilitation, University of Groningen, University Medical Center Groningen, The Netherlands.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1510549']
446,31558345,"Prevalence, Risk, and Genetic Association of Reticular Pseudodrusen in Age-related Macular Degeneration: Age-Related Eye Disease Study 2 Report 21.","PURPOSE
To determine the prevalence of reticular pseudodrusen (RPD) in eyes with age-related macular degeneration (AMD), assess the role of RPD as an independent risk factor for late AMD development, and evaluate genetic association with RPD.
DESIGN
Prospective cohort study.
PARTICIPANTS
Participants with intermediate AMD in 1 or both eyes enrolled in the Age-Related Eye Disease Study 2 (AREDS2), a 5-year multicenter study of nutritional supplement.
METHODS
Fundus autofluorescence (FAF) images from a subset of AREDS2 participants were evaluated at annual visits for presence of RPD. Six single nucleotide polymorphisms-rs10490924 (ARMS2), rs1061170 (CFH), rs2230199 (C3), rs116503776 and rs114254831 (C2/CFB), and rs943080 (VEGF-A)-and the genetic risk score (GRS) were assessed for association with RPD. Development of late AMD, defined as geographic atrophy (GA) or neovascular AMD (NVAMD), was identified.
MAIN OUTCOME MEASURES
Prevalence of RPD, odds ratio (OR) of late AMD development, and genetic associations of RPD.
RESULTS
The FAF images were evaluated for 5021 eyes (2516 participants). Reticular pseudodrusen were seen in 1186 eyes (24% of eyes, 29% of participants). Prevalence of RPD varied with baseline AREDS AMD severity level: 6% in early AMD (n = 458), 26% in intermediate AMD (n = 2606), 36% in GA (n = 682), and 19% in NVAMD (n = 1246). Mean age of participants with RPD was 79 years (standard deviation [SD], 7) and 75 years (SD, 8) in those without RPD (P < 0.0001). Reticular pseudodrusen were more frequent in female participants (65% RPD vs. 53% no RPD). Odds ratio adjusted for baseline age, gender, race, educational status, smoking, and AMD severity level for 1710 eyes at risk of developing late AMD at the next annual visit was 2.42 (95% confidence interval [CI], 1.80-3.24; P < 0.001) for GA and 1.21 (95% CI, 0.87-1.7; P = 0.26) for NVAMD. Presence of RPD was significantly associated with higher GRS (P < 0.0001) and ARMS2 risk alleles (P < 0.0001) and, at a nominal level, with C3 risk alleles (P = 0.04) and CFH risk alleles (P = 0.048 for homozygotes).
CONCLUSIONS
Participants with RPD have an increased risk of progression to GA but not NVAMD. ARMS2 risk alleles and higher GRS were associated with the presence of RPD. This study suggests that RPD are an important risk marker and should be included in classification systems used for patient prognosis.",2019,"Reticular pseudodrusen were seen in 1186 eyes (24% of eyes, 29% of participants).","['Fundus autofluorescence (FAF) images from a subset of AREDS2 participants were evaluated at annual visits for presence of RPD', 'Participants with intermediate AMD in 1 or both eyes enrolled in the Age-Related Eye Disease Study 2 (AREDS2), a 5-year multicenter study of nutritional supplement', '5021 eyes (2516 participants', 'eyes with age-related macular degeneration (AMD']",['ARMS2'],"['risk of progression to GA', 'risk alleles and higher GRS', 'CFH risk alleles', 'Prevalence, Risk, and Genetic Association of Reticular Pseudodrusen', 'Prevalence of RPD, odds ratio (OR) of late AMD development, and genetic associations of RPD', 'Six single nucleotide polymorphisms-rs10490924 (ARMS2), rs1061170 (CFH), rs2230199 (C3), rs116503776 and rs114254831 (C2/CFB), and rs943080 (VEGF-A)-and the genetic risk score (GRS', 'prevalence of reticular pseudodrusen (RPD', 'ARMS2 risk alleles']","[{'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0229118', 'cui_str': 'OU - Both eyes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2609282', 'cui_str': 'Reticular pseudodrusen'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0769975', 'cui_str': 'cholesteryl-p-fluorobenzoate'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",5021.0,0.0576557,"Reticular pseudodrusen were seen in 1186 eyes (24% of eyes, 29% of participants).","[{'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin. Electronic address: domalpally@wisc.edu.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland.'}, {'ForeName': 'Jeong W', 'Initials': 'JW', 'LastName': 'Pak', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Tiarnan D', 'Initials': 'TD', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland.'}, {'ForeName': 'Fredrick L', 'Initials': 'FL', 'LastName': 'Ferris', 'Affiliation': 'Ophthalmic Research Consultants, Waxhaw, North Carolina.'}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, Bethesda, Maryland.'}]",Ophthalmology,['10.1016/j.ophtha.2019.07.022']
447,32171028,Intervention fidelity and process outcomes of medication reviews including post-discharge follow-up in older hospitalized patients: Process evaluation of the MedBridge trial.,"WHAT IS KNOWN AND OBJECTIVE
Drug-related problems (DRPs) are a growing healthcare burden worldwide. In an ongoing cluster-randomized controlled trial in Sweden (MedBridge), comprehensive medication reviews (CMRs) including post-discharge follow-up have been conducted in older hospitalized patients to prevent and solve DRPs. As part of a process evaluation of the MedBridge trial, this study aimed to assess the intervention fidelity and process outcomes of the trial's interventions.
METHODS
For intervention delivery, the percentage of patients that received intervention components was calculated per study group. Process outcomes, measured in about one-third of all intervention patients, included the following: the number of identified medication discrepancies, DRPs and recommendations to solve DRPs, correction rate of discrepancies, and implementation rate of recommendations.
RESULTS AND DISCUSSION
The MedBridge trial included 2637 patients (mean age: 81 years). The percentage of intervention patients (n = 1745) that received the intended intervention components was 94%-98% during admission, and 40%-81% upon and after discharge. The percentage of control patients (n = 892) that received at least one unintended intervention component was 15%. On average, 1.1 discrepancies and 2.0 DRPs were identified in 652 intervention patients. The correction and implementation rates were 79% and 73%, respectively. Stop medication was the most frequently implemented recommendation (n = 293) and 77% of the patients had at least one corrected discrepancy or implemented recommendation.
WHAT IS NEW AND CONCLUSION
The intervention fidelity within the MedBridge trial was high for CMRs during hospital stay and lower for intervention components upon and after discharge. The high prevalence of corrected discrepancies and implemented recommendations may explain potential effects of CMRs in the MedBridge trial.",2020,The intervention fidelity within the MedBridge trial was high for CMRs during hospital stay and lower for intervention components upon and after discharge.,"['652 intervention patients', 'older hospitalized patients', '2637 patients (mean age: 81\xa0years']",[],"['number of identified medication discrepancies, DRPs and recommendations to solve DRPs, correction rate of discrepancies, and implementation rate of recommendations', 'correction and implementation rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}]",2637.0,0.0919464,The intervention fidelity within the MedBridge trial was high for CMRs during hospital stay and lower for intervention components upon and after discharge.,"[{'ForeName': 'Thomas G H', 'Initials': 'TGH', 'LastName': 'Kempen', 'Affiliation': 'Hospital Pharmacy Department, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Cam', 'Affiliation': 'Hospital Pharmacy Department, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kälvemark', 'Affiliation': 'Hospital Pharmacy Department, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Karl-Johan', 'Initials': 'KJ', 'LastName': 'Lindner', 'Affiliation': 'Pharmacy Department, Region Västmanland, Västerås, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Melhus', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Elisabet I', 'Initials': 'EI', 'LastName': 'Nielsen', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Sulku', 'Affiliation': 'Centre for Research and Development, Uppsala University/Region Gävleborg, Gävle, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Gillespie', 'Affiliation': 'Hospital Pharmacy Department, Uppsala University Hospital, Uppsala, Sweden.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13128']
448,30625189,Pilot study of probiotic/colostrum supplementation on gut function in children with autism and gastrointestinal symptoms.,"Over half of all children with autism spectrum disorders (ASD) have gastrointestinal (GI) co-morbidities including chronic constipation, diarrhea, and irritable bowel syndrome. The severity of these symptoms has been correlated with the degree of GI microbial dysbiosis. The study objective was to assess tolerability of a probiotic (Bifidobacterium infantis) in combination with a bovine colostrum product (BCP) as a source of prebiotic oligosaccharides and to evaluate GI, microbiome and immune factors in children with ASD and GI co-morbidities. This pilot study is a randomized, double blind, controlled trial of combination treatment (BCP + B. infantis) vs. BCP alone in a cross-over study in children ages 2-11 with ASD and GI co-morbidities (n = 8). This 12-week study included 5 weeks of probiotic-prebiotic supplementation, followed by a two-week washout period, and 5 weeks of prebiotic only supplementation. The primary outcome of tolerability was assessed using validated questionnaires of GI function and atypical behaviors, along with side effects. Results suggest that the combination treatment is well-tolerated in this cohort. The most common side effect was mild gassiness. Some participants on both treatments saw a reduction in the frequency of certain GI symptoms, as well as reduced occurrence of particular aberrant behaviors. Improvement may be explained by a reduction in IL-13 and TNF-α production in some participants. Although limited conclusions can be drawn from this small pilot study, the results support the need for further research into the efficacy of these treatments.",2019,"Some participants on both treatments saw a reduction in the frequency of certain GI symptoms, as well as reduced occurrence of particular aberrant behaviors.","['children with autism and gastrointestinal symptoms', 'children with autism spectrum disorders (ASD', 'children with ASD and GI co-morbidities', 'children ages 2-11 with ASD and GI co-morbidities (n = 8']","['probiotic (Bifidobacterium infantis', 'combination treatment (BCP + B. infantis) vs. BCP alone', 'probiotic-prebiotic supplementation', 'bovine colostrum product (BCP', 'probiotic/colostrum supplementation']","['tolerability', 'IL-13 and TNF-α production', 'validated questionnaires of GI function and atypical behaviors, along with side effects', 'gut function', 'frequency of certain GI symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0314976', 'cui_str': 'Bifidobacterium Infantis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}]","[{'cui': 'C0214743', 'cui_str': 'IL13'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0033268'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0638855,"Some participants on both treatments saw a reduction in the frequency of certain GI symptoms, as well as reduced occurrence of particular aberrant behaviors.","[{'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Sanctuary', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, United States of America.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Kain', 'Affiliation': 'Department of Neurobiology, Physiology and Behavior, University of California, Davis, California, United States of America.'}, {'ForeName': 'Shin Yu', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Food Science and Technology, University of California, Davis, California, United States of America.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, University of California, Davis, California, United States of America.'}, {'ForeName': 'Danielle G', 'Initials': 'DG', 'LastName': 'Lemay', 'Affiliation': 'USDA ARS Western Human Nutrition Research Center, Davis, California, United States of America.'}, {'ForeName': 'Destanie R', 'Initials': 'DR', 'LastName': 'Rose', 'Affiliation': 'MIND Institute, University of California Davis, Sacramento, California, United States of America.'}, {'ForeName': 'Houa T', 'Initials': 'HT', 'LastName': 'Yang', 'Affiliation': 'MIND Institute, University of California Davis, Sacramento, California, United States of America.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Tancredi', 'Affiliation': 'Department of Pediatrics, University of California School of Medicine, Sacramento, California, United States of America.'}, {'ForeName': 'J Bruce', 'Initials': 'JB', 'LastName': 'German', 'Affiliation': 'Department of Food Science and Technology, University of California, Davis, California, United States of America.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Slupsky', 'Affiliation': 'Department of Nutrition, University of California, Davis, California, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': 'MIND Institute, University of California Davis, Sacramento, California, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, University of California, Davis, California, United States of America.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Department of Food Science and Technology, University of California, Davis, California, United States of America.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Angkustsiri', 'Affiliation': 'MIND Institute, University of California Davis, Sacramento, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0210064']
449,32171064,"Predictive value of blood eosinophils and exhaled nitric oxide in adults with mild asthma: a prespecified subgroup analysis of an open-label, parallel-group, randomised controlled trial.","BACKGROUND
Whether blood eosinophil counts and exhaled nitric oxide (FeNO) are associated with important outcomes in mild asthma is unclear. In this prespecified subgroup analysis of a previously published open-label clinical trial, we aimed to assess associations between blood eosinophil counts and FeNO with outcomes and response to asthma treatment.
METHODS
In the previously reported 52-week, open-label, randomised controlled trial, people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia. Eligible participants were randomly assigned (1:1:1, stratified by country), to receive inhalers to take as-needed salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler). The primary outcome was the annual rates of asthma exacerbations per patient, and in this prespecified subgroup analysis, we assessed whether annual exacerbation rates in each treatment group were significantly different depending on levels of blood eosinophil count, FeNO, or a composite score of both. Analyses were done for patients with available biomarker measurements The study was registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12615000999538.
FINDINGS
675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO. Of the patients who received as-needed salbutamol, the proportion of patients having a severe exacerbation increased progressively with increasing blood eosinophil count (two [4%] of 49 participants with <0·15 × 10 9 /L, six [6%] of 93 with 0·15 to <0·3 × 10 9 /L, and 15 [19%] of 77 with ≥0·3 × 10 9 /L; p=0·014). There were no significant interactions between blood eosinophil count or FeNO level and the effect of as-needed budesonide-formoterol compared with as-needed salbutamol for either exacerbations or severe exacerbations. However, there were significant interactions between blood eosinophil count subgroups and the effect of maintenance budesonide plus as-needed salbutamol compared with as-needed salbutamol, both for exacerbations (p=0·0006) and severe exacerbations (p=0·0007). Maintenance budesonide plus as-needed salbutamol was more effective than as-needed salbutamol in patients with blood eosinophil counts of 0·3 × 10 9 /L or more, both for exacerbations (rate ratio 0·13 [95% CI 0·05-0·33]) and severe exacerbations (risk odds ratio 0·11 [0·03-0·45]). This difference was not seen for blood eosinophil counts of less than 0·15 × 10 9 /L (1·15 [0·51-1·28] for exacerbations and 5·72 [0·97-33·60] for severe exacerbations). There was no consistent interaction between treatment response and FeNO or the composite score.
INTERPRETATION
In patients with mild asthma, the effects of as-needed budesonide-formoterol on exacerbations are independent of biomarker profile, whereas the benefits of maintenance inhaled budesonide are greater in patients with high blood eosinophil counts than in patients with low counts.
FUNDING
AstraZeneca, Health Research Council of New Zealand.",2020,This difference was not seen for blood eosinophil counts of less than 0·15 ,"['10', 'patients with blood eosinophil counts of 0·3', '675 participants were enrolled between March 17, 2016, and Aug 29, 2017, of whom 656 had results for blood eosinophil analysis and 668 had results for FeNO', 'people with mild asthma receiving only β agonist reliever inhalers were enrolled at one of 16 clinical trials units in New Zealand, the UK, Italy, or Australia', '0·13', 'patients with available biomarker measurements', '10 9', '49 participants with <0·15', 'patients with mild asthma', 'adults with mild asthma', 'Eligible participants']","['budesonide-formoterol', 'blood eosinophils and exhaled nitric oxide', 'salbutamol (two inhalations of 100 μg in a pressurised metered dose inhaler), maintenance budesonide (200 μg twice per day by inhaler) plus as-needed salbutamol (two inhalations of 100 μg), or as-needed budesonide-formoterol (one inhalation of 200 μg budesonide and 6μg formoterol by inhaler']","['blood eosinophil count', 'annual exacerbation rates', 'blood eosinophil counts', 'severe exacerbations', 'annual rates of asthma exacerbations', 'exacerbations (rate ratio', 'blood eosinophil count or FeNO level', 'levels of blood eosinophil count, FeNO, or a composite score of both']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4517854', 'cui_str': '675 (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",675.0,0.625881,This difference was not seen for blood eosinophil counts of less than 0·15 ,"[{'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Oxford Respiratory National Institute for Health Research Biomedical Research Centre, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ebmeier', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Department of Respiratory Medicine, Waikato Hospital, Hamilton, New Zealand; Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Houghton', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Oldfield', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Respiratory Medicine Unit, Department of Medical Sciences, Università di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Capital and Coast District Health Board, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30053-9']
450,32169314,"Reply to Wei Liu, Xiaoping Liu, Sheng Li's Letter to the Editor, re: Robert A. Huddart, Emma Hall, Rebecca Lewis, et al. Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial. Eur Urol 2020;77:260-8.",,2020,,['Patients Treated for Muscle-invasive Bladder Cancer with'],['Radiotherapy ± Chemotherapy'],['Quality of Life Outcomes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[{'cui': 'C0034380'}],,0.0777941,,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huddart', 'Affiliation': 'Institute of Cancer Research, London, UK; Royal Marsden NHS Foundation Trust, London, UK. Electronic address: robert.huddart@icr.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Syed A', 'Initials': 'SA', 'LastName': 'Hussain', 'Affiliation': 'Academic Unit of Oncology, Department of Oncology and Metabolism, Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Institute of Cancer Research, London, UK; University of Birmingham, Birmingham, UK; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}]",European urology,['10.1016/j.eururo.2020.02.013']
451,31358390,The Association of Aspirin Use with Age-Related Macular Degeneration Progression in the Age-Related Eye Disease Studies: Age-Related Eye Disease Study 2 Report No. 20.,"PURPOSE
To analyze the potential association between aspirin use and progression of age-related macular degeneration (AMD).
DESIGN
Two prospective cohort studies within 2 controlled clinical trials of oral supplementation for age-related eye disease.
PARTICIPANTS
Age-Related Eye Disease Study (AREDS) participants 55 to 80 years of age and AREDS2 participants 50 to 85 years of age.
METHODS
Propensity scores for aspirin use were calculated for AREDS and AREDS2 participants separately by logistic regression. Of the participants without late AMD (geographic atrophy [GA] or neovascular AMD) in either eye at study baseline, aspirin users were matched 1:1 with nonusers by propensity score (separately for AREDS and AREDS2). Proportional hazards regression was performed, adjusting for age, on the matched participants to evaluate associations between aspirin propensity score and progression to late AMD (and its subtypes).
MAIN OUTCOME MEASURES
Progression to late AMD on color fundus photographs, graded centrally.
RESULTS
Of the 3734 eligible AREDS participants, 1049 (28.1%) were taking aspirin, and of the 2403 eligible AREDS2 participants, 1198 (49.9%) were taking aspirin. After matching by propensity score, the characteristics of the users and nonusers were similar in both studies. Of the 1950 matched AREDS participants and 1694 matched AREDS2 participants, over a median follow-up of 10.1 years and 5.0 years, respectively, the numbers who progressed to late AMD, GA, or neovascular AMD were 454 (23.3%), 345 (17.7%), and 278 (14.3%), respectively, in AREDS and 643 (38.0%), 402 (24.6%), and 341 (20.1%) in AREDS2. The hazard ratios of progression in quintile 5 (highest propensity for aspirin use) versus 1 (reference) were 1.17 (P = 0.35), 1.24 (0.25), and 0.95 (0.81), respectively, in AREDS and 1.26 (0.09), 1.46 (0.03), and 1.12 (0.58) in AREDS2. No significant association with progression to late AMD was observed for quintiles 2 through 5 for any of the 3 outcomes in either study.
CONCLUSIONS
Aspirin use was not associated significantly with progression to late AMD or its subtypes in either the AREDS or AREDS2. Patients with AMD need not avoid aspirin for this reason when its use is medically indicated.",2019,"No significant association with progression to late AMD was observed for quintiles 2 through 5 for any of the 3 outcomes in either study.
","['Patients with AMD', 'for age-related eye disease', 'Age-Related Eye Disease Study (AREDS) participants 55 to 80 years of age and AREDS2 participants 50 to 85 years of age', 'Of the 3734 eligible AREDS participants, 1049 (28.1%) were taking aspirin, and of the 2403 eligible AREDS2 participants, 1198 (49.9%) were taking']","['aspirin', 'oral supplementation', 'Aspirin']","['numbers who progressed to late AMD, GA, or neovascular AMD', 'hazard ratios of progression', 'progression to late AMD', 'Progression to late AMD on color fundus photographs, graded centrally']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",55.0,0.0250683,"No significant association with progression to late AMD was observed for quintiles 2 through 5 for any of the 3 outcomes in either study.
","[{'ForeName': 'Tiarnan D', 'Initials': 'TD', 'LastName': 'Keenan', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wiley', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Agrón', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Aronow', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Christen', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Traci E', 'Initials': 'TE', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Emily Y', 'Initials': 'EY', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland. Electronic address: echew@nei.nih.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology,['10.1016/j.ophtha.2019.06.023']
452,32175973,Significant Dose-Response between Exercise Adherence and Hemoglobin A1c Change.,"INTRODUCTION
The Diabetes Aerobic and Resistance Exercise trial found that aerobic training and resistance training alone each reduced hemoglobin A1c (HbA1c) compared with nonexercising controls, and combined aerobic and resistance training caused greater HbA1c reduction than either training type alone. Our objective was to determine whether a dose-response relationship existed between frequency of exercise training and HbA1c change, and whether this varied by exercise modality or participant characteristics.
METHODS
Post hoc analysis of data from 185 Diabetes Aerobic and Resistance Exercise trial participants with type 2 diabetes randomized to aerobic, resistance or combined training thrice weekly. Dose-response relationships between adherence (percent of prescribed training sessions completed) and HbA1c change were assessed with linear regression.
RESULTS
Median overall adherence was 84.9% (interquartile range, 74.4%-93.6%). Higher exercise adherence was associated with greater HbA1c reduction; a 20% increase in adherence (e.g., an additional two sessions per month) was associated with a 0.15% (2 mmol·mol) decrease in HbA1c (β = -0.0076, R = -0.170, P = 0.021). Significant dose-response relationships were identified for aerobic (β = -0.0142, R = -0.313, P = 0.016) and combined training (β = -0.0109, R = -0.259, P = 0.041), but not resistance training (β = 0.0068, R = 0.153, P = 0.233). Dose-response relationships in all training groups combined were significant in subgroups younger than 55 yr (β = -0.0113, R = -0.286, P = 0.005), males (β = -0.0123, R = -0.234, P = 0.010), and baseline HbA1c ≥7.5% (58 mmol·mol) (β = -0.013, R = -0.263, P = 0.011).
CONCLUSIONS
There was a dose-response relationship between adherence to prescribed exercise and HbA1c reduction suggesting that glycemic control is improved more in individuals with type 2 diabetes with a higher training volume. Dose-response relationships existed for aerobic and combined training but not resistance training. These findings support aerobic and combined exercise prescriptions outlined in clinical practice guidelines.",2020,There was a dose-response relationship between adherence to prescribed exercise and HbA1c reduction suggesting that glycemic control is improved more in individuals with type 2 diabetes with a higher training volume.,"['Post-hoc analysis of data from 185 DARE trial participants with type 2 diabetes randomized to aerobic, resistance or combined training thrice weekly']",['aerobic training and resistance training'],"['Median overall adherence', 'Higher exercise adherence', 'HbA1c reduction', 'adherence']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0444395,There was a dose-response relationship between adherence to prescribed exercise and HbA1c reduction suggesting that glycemic control is improved more in individuals with type 2 diabetes with a higher training volume.,"[{'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Benham', 'Affiliation': '1Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA 2Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA 3Departments of Pediatrics, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA 4Department of Community Health and Epidemiology, Dalhousie University, Halifax, NS, CANADA 5Faculty of Kinesiology, Sport, and Recreation, Alberta Diabetes Institute, University of Alberta, Edmonton, AB, CANADA 6School of Human Kinetics, Faculty of Health Sciences, University of Ottawa, Ottawa, ON, CANADA 7Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, CANADA 8Institut du Savoir Montfort, Ottawa, ON, CANADA 9Department of Cardiac Sciences and Faculty of Kinesiology, Cumming School of Medicine, University of Calgary, Calgary, AB, CANADA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Booth', 'Affiliation': ''}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Dunbar', 'Affiliation': ''}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Doucette', 'Affiliation': ''}, {'ForeName': 'Normand G', 'Initials': 'NG', 'LastName': 'BoulÉ', 'Affiliation': ''}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': ''}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""Prud'homme"", 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002339']
453,32164888,Clinical and Pharmacological Effects of Apixaban Dose Adjustment in the ARISTOTLE Trial.,"BACKGROUND
In the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, patients with atrial fibrillation and ≥2 dose-adjustment criteria (age ≥80 years, weight ≤60 kg, or creatinine ≥1.5 mg/dl [133 μmol/l]) were randomized to receive apixaban 2.5 mg twice daily or warfarin.
OBJECTIVES
The purpose of this study was to describe the effects of apixaban dose adjustment on clinical and pharmacological outcomes.
METHODS
Patients receiving the correct dose of study drug were included (n = 18,073). The effect of apixaban 2.5 mg twice daily versus warfarin on population pharmacokinetics, D-dimer, prothrombin fragment 1 + 2 (PF1+2), and clinical outcomes was compared with the standard dose (5 mg twice daily).
RESULTS
Patients receiving apixaban 2.5 mg twice daily exhibited lower apixaban exposure (median area under the concentration time curve at a steady state 2,720 ng/ml vs. 3,599 ng/ml; p < 0.0001) than those receiving the standard dose. In patients with ≥2 dose-adjustment criteria, reductions in D-dimers (p interaction = 0.20) and PF1+2 (p interaction = 0.55) were consistent with those observed in the standard-dose population. Patients with ≥2 dose-adjustment criteria (n = 751) were at higher risk for stroke/systemic embolism, major bleeding, and all-cause death than the standard-dose population (0 or 1 dose-adjustment criterion, n = 17,322). The effect of apixaban 2.5 mg twice daily versus warfarin in the ≥2 dose-adjustment criteria population was consistent with the standard dose in the reductions in stroke or systemic embolism (p interaction = 0.26), major bleeding (p interaction = 0.25), and death (p interaction = 0.72).
CONCLUSIONS
Apixaban drug concentrations were lower in patients receiving 2.5 mg twice daily compared with 5 mg twice daily. However, the effects of apixaban dose adjustment to 2.5 mg versus warfarin were consistent for coagulation biomarkers and clinical outcomes, providing reassuring data on efficacy and safety. (Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation [ARISTOTLE]; NCT00412984).",2020,"In patients with ≥2 dose-adjustment criteria, reductions in D-dimers (p interaction = 0.20) and PF1+2 (p interaction = 0.55) were consistent with those observed in the standard-dose population.","['Patients with\xa0≥2 dose-adjustment criteria (n\xa0=\xa0751) were at higher risk for stroke/systemic embolism, major bleeding, and all-cause death than the standard-dose population (0 or 1 dose-adjustment criterion, n = 17,322', 'Patients receiving the correct dose of study drug were included (n\xa0=\xa018,073', 'patients with atrial fibrillation and\xa0≥2 dose-adjustment criteria (age\xa0≥80 years, weight\xa0≤60\xa0kg, or creatinine\xa0≥1.5\xa0mg/dl [133\xa0μmol/l']","['apixaban 2.5\xa0mg twice daily versus warfarin', 'Apixaban', 'warfarin', 'apixaban', 'apixaban 2.5\xa0mg twice daily or warfarin']","['efficacy and safety', 'major bleeding', 'stroke or systemic embolism']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C4517563', 'cui_str': '133'}]","[{'cui': 'C3530467', 'cui_str': 'apixaban 2.5 MG [Eliquis]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}]",751.0,0.165369,"In patients with ≥2 dose-adjustment criteria, reductions in D-dimers (p interaction = 0.20) and PF1+2 (p interaction = 0.55) were consistent with those observed in the standard-dose population.","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giczewska', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Christersson', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Department of Medical Sciences, Clinical Chemistry, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center (UCR), Uppsala, Sweden.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Division of Cardiovascular Medicine, Cardio-Thoracic and Vascular Department, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Cardiology Department, AP-HP, Hôpital Bichat, FACT, Université de Paris and INSERM, Paris, France.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center (UCR), Uppsala, Sweden.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address: john.h.alexander@duke.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.12.060']
454,30891657,Computerized neurocognitive training for improving dietary health and facilitating weight loss.,"Nearly 70% of Americans are overweight, in large part because of overconsumption of high-calorie foods such as sweets. Reducing sweets is difficult because powerful drives toward reward overwhelm inhibitory control (i.e., the ability to withhold a prepotent response) capacities. Computerized inhibitory control trainings (ICTs) have shown positive outcomes, but impact on real-world health behavior has been variable, potentially because of limitations inherent in existing paradigms, e.g., low in frequency, intrinsic enjoyment, personalization, and ability to adapt to increasing ability. The present study aimed to assess the feasibility, acceptability, and efficacy of a gamified and non-gamified, daily, personalized, and adaptive ICT designed to facilitate weight loss by targeting consumption of sweets. Participants (N = 106) were randomized to one of four conditions in a 2 (gamified vs. non-gamified) by 2 (ICT vs. sham) factorial design. Participants were prescribed a no-added-sugar diet and completed 42 daily, at-home trainings, followed by two weekly booster trainings. Results indicated that the ICTs were feasible and acceptable. Surprisingly, compliance to the 44 trainings was excellent (88.8%) and equivalent across both gamified and non-gamified conditions. As hypothesized, the impact of ICT on weight loss was moderated by implicit preference for sweet foods [F(1,95) = 6.17, p = .02] such that only those with higher-than-average implicit preference benefited (8-week weight losses for ICT were 3.1% vs. 2.2% for sham). A marginally significant effect was observed for gamification to reduce the impact of ICT. Implications of findings for continued development of ICTs to impact health behavior are discussed.",2019,"Surprisingly, compliance to the 44 trainings was excellent (88.8%) and equivalent across both gamified and non-gamified conditions.",['Participants (N\u2009=\u2009106'],"['gamified and non-gamified, daily, personalized, and adaptive ICT', 'Computerized neurocognitive training', 'Computerized inhibitory control trainings (ICTs']","['dietary health and facilitating weight loss', 'feasibility, acceptability, and efficacy', 'weight loss']",[],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",106.0,0.0424756,"Surprisingly, compliance to the 44 trainings was excellent (88.8%) and equivalent across both gamified and non-gamified conditions.","[{'ForeName': 'Evan M', 'Initials': 'EM', 'LastName': 'Forman', 'Affiliation': 'Drexel University, Philadelphia, USA. emf27@drexel.edu.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Manasse', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Diane H', 'Initials': 'DH', 'LastName': 'Dallal', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Crochiere', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Caitlin M', 'Initials': 'CM', 'LastName': 'Loyka', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Juarascio', 'Affiliation': 'Drexel University, Philadelphia, USA.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Houben', 'Affiliation': 'Maastricht University, Maastricht, The Netherlands.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00024-5']
455,32161164,Changes in mean arterial pressure and end-tidal carbon dioxide content affect venous sinus pressures in patients with idiopathic intracranial hypertension: a randomized study.,"INTRODUCTION
Little is known about how changes in physiologic parameters affect venous sinus pressure measurements, waveforms, or gradients associated with sinus stenosis.
OBJECTIVE
To evaluate the effect of changes in cardiovascular and respiratory physiologic parameters on venous sinus pressure and caliber measurements in patients with idiopathic intracranial hypertension (IIH) undergoing venous sinus stenting.
METHODS
In a prospective, randomized pilot study, eight patients with IIH undergoing venous sinus stenting were randomized to one of two groups. Under general anesthesia, patients underwent venous manometry and waveform recordings twice in succession based on assigned physiologic groups immediately before stenting. The mean arterial pressure (MAP) group maintained normocapnia but modified MAPs in two arms to control for temporal confounding: group A1 (MAP 60-80 mm Hg then 100-110 mm Hg) and group A2 (MAP 100-110 mm Hg then 60-80 mm Hg). The end-tidal carbon dioxide (EtCO 2 ) group maintained a high-normal MAP similar to standard neuroanesthesia goals and modified EtCO 2 : group B1 (EtCO 2 24-26 mm Hg then 38-40 mm Hg) and B2 (EtCO 2 28-40 mm Hg then 24-26 mm Hg).
RESULTS
In group A, superior sagittal sinus (SSS) pressures (ranging from 8 to 76 mm Hg) and trans-stenotic pressure gradients (TSPGs) (ranging from 2 to 67 mm Hg) were seen at MAP of 100-110 mm Hg compared with SSS pressures (4-38 mm Hg) and TSPGs (3-31 mm Hg) at 60-80 mm Hg. In group B, SSS pressures and TSPGs were considerably higher at EtCO 2 levels of 38-40 mm Hg (15-57 mm Hg and 3-44 mm Hg, respectively) than at 24-26 mm Hg (8-26 mm Hg and 1-8 mm Hg, respectively).
CONCLUSIONS
Despite the small sample size, this pilot study demonstrates a dramatic effect of both MAP and EtCO 2 on venous sinus pressures obtained during venography. These findings underscore the importance of maintaining normal physiologic cardiovascular and respiratory parameters during venous sinus manometry.",2020,"In group B, SSS pressures and TSPGs were considerably higher at EtCO 2 levels of 38-40 mm Hg (15-57 mm Hg and 3-44 mm Hg, respectively) than at 24-26 mm Hg (8-26 mm Hg and 1-8 mm Hg, respectively).
","['patients with idiopathic intracranial hypertension', 'eight patients with IIH undergoing venous sinus stenting', 'patients with idiopathic intracranial hypertension (IIH) undergoing venous sinus stenting']",['tidal carbon dioxide (EtCO 2 ) group maintained a high-normal MAP similar to standard neuroanesthesia goals and modified EtCO 2 : group B1 (EtCO 2 24-26 mm'],"['superior sagittal sinus (SSS) pressures', 'SSS pressures and TSPGs', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033845', 'cui_str': 'Idiopathic Intracranial Hypertension'}, {'cui': 'C0226504', 'cui_str': 'Structure of venous sinus'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0226859', 'cui_str': 'Sinus Sagittalis Superior'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",8.0,0.0565719,"In group B, SSS pressures and TSPGs were considerably higher at EtCO 2 levels of 38-40 mm Hg (15-57 mm Hg and 3-44 mm Hg, respectively) than at 24-26 mm Hg (8-26 mm Hg and 1-8 mm Hg, respectively).
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tschoe', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA ctschoe@wakehealth.edu.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Garner', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Kittel', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Traunero', 'Affiliation': 'Department of Anesthesiology, Wake Forest University School of Medicine, Winston Salem, North Carolina, USA.'}, {'ForeName': 'Stacey Q', 'Initials': 'SQ', 'LastName': 'Wolfe', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Fargen', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015741']
456,32164882,Nonculprit Lesion Myocardial Infarction Following Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome.,"BACKGROUND
Recent emphasis on reduced duration and/or intensity of antiplatelet therapy following percutaneous coronary intervention (PCI) irrespective of indication for PCI may fail to account for the substantial risk of subsequent nontarget lesion events in acute coronary syndrome (ACS) patients.
OBJECTIVES
The authors sought to examine the effect of more potent antiplatelet therapy on the basis of the timing and etiology of recurrent myocardial infarction (MI) or cardiovascular death following PCI for ACS.
METHODS
In the TRITON-TIMI 38 study (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis In Myocardial Infarction 38), which randomized patients to prasugrel or clopidogrel, 12,844 patients with ACS received at least 1 stent. MI and cardiovascular death were categorized as: 1) procedural (related to revascularization); 2) definite or probable stent thrombosis (ST); or 3) spontaneous (non-ST or non-procedure-related). Median follow-up was 14.5 months.
RESULTS
Among the first events occurring within 30 days, 584 (69.0%) were procedural, 126 (14.9%) ST-related, and 136 (16.1%) spontaneous. After 30 days, 22 (4.7%) were procedural, 63 (13.5%) were ST-related, and 383 (81.8%) spontaneous. Prasugrel significantly reduced the incidence of MI or cardiovascular death for ST-related (1.0% vs. 2.1%; p < 0.001) and spontaneous events (3.9% vs. 4.8%; p = 0.012), with a directionally consistent numerical reduction for procedural events (4.4% vs. 5.1%; p = 0.078). Prasugrel increased spontaneous, but not procedural, major bleeding.
CONCLUSIONS
Long-term potent antithrombotic therapy reduces de novo (spontaneous) atherothrombotic events in addition to preventing complications associated with stenting of the culprit lesion following ACS. In patients undergoing PCI for ACS, spontaneous events predominate after 30 days, with the later-phase cardiovascular benefit of potent dual antiplatelet therapy driven largely by reducing de novo atherothrombotic ischemic events. (Comparison of Prasugrel [CS-747] and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention; NCT00097591).",2020,"After 30 days, 22 (4.7%) were procedural, 63 (13.5%) were ST-related, and 383 (81.8%) spontaneous.","['12,844 patients with ACS received at least 1 stent', 'acute coronary syndrome (ACS) patients', 'Patients With Acute\xa0Coronary Syndrome', 'Acute Coronary Syndrome Subjects']","['Prasugrel [CS-747', 'Percutaneous Coronary Intervention', 'prasugrel or clopidogrel', 'Prasugrel', 'Clopidogrel', 'percutaneous coronary intervention (PCI', 'Prasugrel-Thrombolysis']","['MI and cardiovascular death', 'recurrent myocardial infarction (MI) or cardiovascular death', 'procedural, major bleeding', 'incidence of MI or cardiovascular death for ST-related', '1) procedural (related to revascularization); 2) definite or probable stent thrombosis (ST); or 3) spontaneous', 'Nonculprit Lesion Myocardial Infarction', 'procedural events', 'spontaneous events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0914294', 'cui_str': 'CS 747'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439672', 'cui_str': 'Spontaneous event (qualifier value)'}]",12844.0,0.0530008,"After 30 days, 22 (4.7%) were procedural, 63 (13.5%) were ST-related, and 383 (81.8%) spontaneous.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: bscirica@partners.org.""}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; CPC Clinical Research, University of Colorado School of Medicine, Denver, Colorado.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.12.067']
457,31792940,Risks and Benefits of Screening for Dementia in Primary Care: The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of Dementia Screening (IU CHOICE)Trial.,"BACKGROUND/OBJECTIVE
The benefits and harms of screening of Alzheimer disease and related dementias (ADRDs) are unknown. This study addressed the question of whether the benefits outweigh the harms of screening for ADRDs among older adults in primary care.
DESIGN, SETTING, AND PARTICIPANTS
Single-blinded, two-arm, randomized controlled trial (October 2012-September 2016) in urban, suburban, and rural primary care settings in Indiana. A total of 4005 primary care patients (aged ≥65 years) were randomized to ADRD screening (n = 2008) or control (n = 1997).
INTERVENTION
Patients were screened using the Memory Impairment Screen or the Mini-Cog and referred for a voluntary follow-up diagnostic assessment if they screened positive on either or both screening tests.
MEASUREMENTS
Primary measures were health-related quality of life (HRQOL; Health Utilities Index) at 12 months, depressive symptoms (Patient Health Questionnaire-9), and anxiety symptoms (Generalized Anxiety Disorder seven-item scale) at 1 month.
RESULTS
The mean age was 74.2 years (SD = 6.9 years); 2257 (66%) were female and 2301 (67%) were white. At 12 months, we were unable to detect differences in HRQOL between the groups (effect size = 0.009 [95% confidence interval {CI} = -0.063 to 0.080]; P = .81). At 1 month, differences in mean depressive symptoms (mean difference = -0.23 [90% CI = -0.42 to -0.039]) and anxiety symptoms (mean difference = -0.087 [90% CI = -0.246 to 0.072]) were within prespecified equivalency range. Scores for depressive and anxiety symptoms were similar between the groups at all time points. No differences in healthcare utilization, advance care planning, and ADRD recognition by physicians were detected at 12 months.
CONCLUSION
We were unable to detect a difference in HRQOL for screening for ADRD among older adults. We found no harm from screening measured by symptoms of depression or anxiety. Missing data, low rates of dementia detection, and high rate of refusal for follow-up diagnostic assessments after a positive screen may explain these findings. J Am Geriatr Soc 68:535-543, 2020.",2020,"At 12 months, we were unable to detect differences in HRQOL between the groups (effect size = 0.009 [95% confidence interval {CI} =","['The mean age was 74.2\u2009years (SD = 6.9\u2009years); 2257 (66%) were female and 2301 (67%) were white', 'Dementia in Primary Care', 'older adults in primary care', 'older adults', '4005 primary care patients (aged ≥65\u2009years', 'Single-blinded, two-arm, randomized controlled trial (October 2012-September 2016) in urban, suburban, and rural primary care settings in Indiana', 'n = 2008) or control (n = 1997']","['Patients were screened using the Memory Impairment Screen or the Mini-Cog and referred for a voluntary follow-up diagnostic assessment if they screened positive on either or both screening tests', 'Dementia Screening (IU CHOICE)Trial', 'ADRD screening']","['anxiety symptoms', 'symptoms of depression or anxiety', 'health-related quality of life (HRQOL; Health Utilities Index) at 12\u2009months, depressive symptoms (Patient Health Questionnaire-9), and anxiety symptoms (Generalized Anxiety Disorder seven-item scale', 'Scores for depressive and anxiety symptoms', 'HRQOL', 'mean depressive symptoms', 'healthcare utilization, advance care planning, and ADRD recognition by physicians']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4721269', 'cui_str': 'Assessment using memory impairment screen (procedure)'}, {'cui': 'C3496553', 'cui_str': 'Mini-Cog'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0431080', 'cui_str': 'Diagnostic assessment (procedure)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]",4005.0,0.259309,"At 12 months, we were unable to detect differences in HRQOL between the groups (effect size = 0.009 [95% confidence interval {CI} =","[{'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Fowler', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Greg A', 'Initials': 'GA', 'LastName': 'Sachs', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Malaz A', 'Initials': 'MA', 'LastName': 'Boustani', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16247']
458,32166308,A Bayesian adaptive randomized phase II multicenter trial of bevacizumab with or without vorinostat in adults with recurrent glioblastoma.,"BACKGROUND
Bevacizumab has promising activity against recurrent glioblastoma (GBM). However, acquired resistance to this agent results in tumor recurrence. We hypothesized that vorinostat, a histone deacetylase (HDAC) inhibitor with anti-angiogenic effects, would prevent acquired resistance to bevacizumab.
METHODS
This multicenter phase II trial used a Bayesian adaptive design to randomize patients with recurrent GBM to bevacizumab alone or bevacizumab plus vorinostat with the primary endpoint of progression-free survival (PFS) and secondary endpoints of overall survival (OS) and clinical outcomes assessment (MD Anderson Symptom Inventory Brain Tumor module [MDASI-BT]). Eligible patients were adults (≥18 y) with histologically confirmed GBM recurrent after prior radiation therapy, with adequate organ function, KPS ≥60, and no prior bevacizumab or HDAC inhibitors.
RESULTS
Ninety patients (bevacizumab + vorinostat: 49, bevacizumab: 41) were enrolled, of whom 74 were evaluable for PFS (bevacizumab + vorinostat: 44, bevacizumab: 30). Median PFS (3.7 vs 3.9 mo, P = 0.94, hazard ratio [HR] 0.63 [95% CI: 0.38, 1.06, P = 0.08]), median OS (7.8 vs 9.3 mo, P = 0.64, HR 0.93 [95% CI: 0.5, 1.6, P = 0.79]) and clinical benefit were similar between the 2 arms. Toxicity (grade ≥3) in 85 evaluable patients included hypertension (n = 37), neurological changes (n = 2), anorexia (n = 2), infections (n = 9), wound dehiscence (n = 2), deep vein thrombosis/pulmonary embolism (n = 2), and colonic perforation (n = 1).
CONCLUSIONS
Bevacizumab combined with vorinostat did not yield improvement in PFS or OS or clinical benefit compared with bevacizumab alone or a clinical benefit in adults with recurrent GBM. This trial is the first to test a Bayesian adaptive design with adaptive randomization and Bayesian continuous monitoring in patients with primary brain tumor and demonstrates the feasibility of using complex Bayesian adaptive design in a multicenter setting.",2020,"CONCLUSIONS
Bevacizumab combined with vorinostat did not yield improvement in PFS, OS or clinical benefit compared with bevacizumab alone nor a clinical benefit in adults with recurrent GBM.","['Ninety patients (bevacizumab+vorinostat:49, bevacizumab:41) were enrolled of whom 74 were evaluable for PFS (bevacizumab+vorinostat:44, bevacizumab:30', 'Eligible patients were adults (≥18 yrs) with histologically confirmed GBM recurrent after prior radiation therapy, with adequate organ function, KPS≥60, and no prior bevacizumab or HDAC inhibitors', '85 evaluable patients included hypertension (n=37), neurological changes (n=2), anorexia (n=2), infections (n=9), wound dehiscence (n=2), DVT/PE (n=2), and colonic perforation (n=1', 'adults with recurrent GBM', 'Adults with Recurrent Glioblastoma', 'randomize patients with recurrent GBM to', 'patients with primary brain tumor']","['bevacizumab', 'bevacizumab alone or bevacizumab plus vorinostat', 'Bevacizumab', 'adaptive randomization and Bayesian continuous monitoring']","['Median PFS', 'progression-free survival (PFS) and secondary end points of overall survival (OS) and clinical outcomes assessment (MDASI-BT', 'Toxicity', 'median OS', 'clinical benefit']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1512474', 'cui_str': 'HDAC Inhibitors'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence (morphologic abnormality)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0347646', 'cui_str': 'Perforation of colon (disorder)'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C0750974', 'cui_str': 'Primary Brain Neoplasms'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0085565', 'cui_str': 'Outcomes Assessment'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.154796,"CONCLUSIONS
Bevacizumab combined with vorinostat did not yield improvement in PFS, OS or clinical benefit compared with bevacizumab alone nor a clinical benefit in adults with recurrent GBM.","[{'ForeName': 'Vinay K', 'Initials': 'VK', 'LastName': 'Puduvalli', 'Affiliation': 'Division of Neuro-Oncoology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center (MDACC), Houston, Texas.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vera', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center (MDACC), Houston, Texas.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Division of Neuro-Oncoology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Giglio', 'Affiliation': 'Division of Neuro-Oncoology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Department of Neurosurgery, Huntsman Cancer Center, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Walbert', 'Affiliation': 'Department of Neurology and Neurosurgery, Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Raizer', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Morris D', 'Initials': 'MD', 'LastName': 'Groves', 'Affiliation': 'Texas Oncology Austin Brain Tumor Center, Austin, Texas.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tran', 'Affiliation': 'Department of Medicine, Washington University, St Louis, Missouri.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Iwamoto', 'Affiliation': 'Division of Neurooncology, Columbia University, New York, New York.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Avgeropoulos', 'Affiliation': 'Orlando Health UF Health Cancer Center, Orlando, Florida.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Paleologos', 'Affiliation': 'Advocate Health Care, Downers Grove, Illinois.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Fink', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peereboom', 'Affiliation': 'Department of Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Merrell', 'Affiliation': 'Department of Neurology, North Shore University Health System, Evanston, Illinois.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Penas Prado', 'Affiliation': 'Department of Neuro-Oncology, The University of \u2009Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'W K Alfred', 'Initials': 'WKA', 'LastName': 'Yung', 'Affiliation': 'Department of Neuro-Oncology, The University of \u2009Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Gilbert', 'Affiliation': 'Neuro-Oncology Branch, National Institute of Health, Bethesda, Maryland.'}]",Neuro-oncology,['10.1093/neuonc/noaa062']
459,32102946,Vitamin D Pathway and Other Related Polymorphisms and Risk of Prostate Cancer: Results from the Prostate Cancer Prevention Trial.,"Vitamin D may influence prostate cancer risk, but evidence is inconsistent. We conducted a nested case-control study in the Prostate Cancer Prevention Trial (PCPT). Cases ( n = 1,128) and controls ( n = 1,205) were frequency matched on age, first-degree relative with prostate cancer, and PCPT treatment arm (finasteride/placebo); African-Americans were oversampled and case/control status was biopsy confirmed. We selected 21 SNPs in vitamin D-related genes (VDR, GC, C10orf88, CYP2R1, CYP24A1, CYP27B1, DHCR7 , and NADSYN1 ) to test genotype and genotype-treatment interactions in relation to prostate cancer. We also tested mean serum 25(OH)D differences by minor allele distributions and tested for serum 25(OH)D-genotype interactions in relation to prostate cancer risk. Log-additive genetic models (Bonferroni-corrected within genes) adjusted for age, body mass index, PSA, and family history of prostate cancer revealed a significant interaction between treatment arm and GC /rs222016 (finasteride OR = 1.37, placebo OR = 0.85; P interaction < 0.05), GC /rs222014 (finasteride OR = 1.36, placebo OR = 0.85; P interaction < 0.05), and CYP27B1 /rs703842 (finasteride OR = 0.76, placebo OR = 1.10; P interaction < 0.05) among Caucasians, and C10orf88 /rs6599638 (finasteride OR = 4.68, placebo OR = 1.39; P interaction < 0.05) among African-Americans. VDR/ rs1544410 and CYP27B1 /rs703842 had significant treatment interactions for high-grade disease among Caucasians (finasteride OR = 0.81, placebo OR = 1.40; P interaction < 0.05 and finasteride OR = 0.70, placebo OR = 1.28; P interaction < 0.05, respectively). Vitamin D-related SNPs influenced serum 25(OH)D, but gene-serum 25(OH)D effect modification for prostate cancer was marginally observed only for CYP24A1 /rs2248359. In conclusion, evidence that vitamin D-related genes or gene-serum 25(OH)D associations influence prostate cancer risk is modest. We found some evidence for gene-finasteride interaction effects for prostate cancer in Caucasians and African-Americans. Results suggest only minimal associations of vitamin D with total or high-grade prostate cancer.",2020,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","['Cases (n=1,128) and controls (n=1,205) were frequency matched on age, first-degree relative with prostate cancer and', 'African-Americans were oversampled and', 'prostate cancer in Caucasians and African-Americans', 'African Americans']","['placebo', 'Vitamin D-related SNPs', 'PCPT treatment arm (finasteride/placebo', 'Vitamin D', 'finasteride', 'CYP27B1/rs703842 (finasteride OR=0.76, placebo', 'GC/rs222014 (finasteride']",[],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0060389', 'cui_str': 'Finasteride'}, {'cui': 'C0000340', 'cui_str': '25-Hydroxyvitamin D2 1-hydroxylase'}]",[],1205.0,0.071002,"finasteride OR=4.68, placebo OR=1.39, p-interaction<0.05) among African Americans.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Torkko', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Cathee', 'Initials': 'C', 'LastName': 'Till', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Goodman', 'Affiliation': 'Division of Public Health Sciences, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Jeannette M', 'Initials': 'JM', 'LastName': 'Schenk', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'M Scott', 'Initials': 'MS', 'LastName': 'Lucia', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Peters', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Adrie', 'Initials': 'A', 'LastName': 'van Bokhoven', 'Affiliation': 'Department of Pathology, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'Christus Santa Rosa Hospital-Medical Center, San Antonio, Texas.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Cancer Prevention Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. mneuhous@fredhutch.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0413']
460,31699704,Effects of One Year of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Biomarkers of Systemic Inflammation in Older US Adults.,"BACKGROUND
Observational studies suggest vitamin D and marine ω-3 fatty acid (n-3 FA) supplements are associated with lower systemic inflammation. However, past trials have been inconsistent.
METHODS
The randomized, double-blind, placebo-controlled VITamin D and OmegA-3 TriaL (VITAL) tested vitamin D (2000 IU/day) and/or n-3 FA (1 g/day) supplementation in a 2 × 2 factorial design among women ≥55 and men ≥50 years of age. We assessed changes in interleukin (IL)-6, tumor necrosis factor receptor 2 (TNFR2), and high-sensitivity C-reactive protein (hsCRP) concentrations from baseline to 1 year among participants randomized to vitamin D + n-3 FA (392), vitamin D (392), n-3 FA (392), or placebo only (385). Geometric means and percent changes were compared, adjusting for baseline factors.
RESULTS
Baseline characteristics were well balanced. In the active arms, 25-OH vitamin D rose 39% and n-3 FA rose 55% vs minimal change in placebo arms. Neither supplement reduced biomarkers at 1 year. Vitamin D resulted in 8.2% higher IL-6 (95% CI, 1.5%-15.3%; adjusted P = 0.02), but TNFR2 and hsCRP did not. Among 784 receiving vitamin D, hsCRP increased 35.7% (7.8%-70.9%) in those with low (<20 ng/mL) but not with higher baseline serum 25(OH) vitamin D [0.45% (-8.9% to 10.8%); P interaction = 0.02]. Among 777 randomized to n-3 FA, hsCRP declined [-10.5% (-20.4% to 0.8%)] in those with baseline low (<1.5 servings/week), but not with higher fish intake [6.4% (95% CI, -7.11% to 21.8%); P interaction = 0.06].
CONCLUSIONS
In this large sample from a population-based randomized controlled trial, neither vitamin D nor n-3 FA supplementation over 1 year decreased these biomarkers of inflammation.
CLINICALTRIALSGOV IDENTIFIER
NCT01169259; NCT01351805.",2019,Vitamin D resulted in 8.2% higher IL-6,"['women ≥55 and men ≥50 years of age', 'Older US Adults']","['placebo-controlled VITamin D and OmegA-3 TriaL', 'Vitamin D and Marine Omega-3 Fatty Acid Supplementation', 'and/or n-3 FA', 'vitamin D, hsCRP', 'vitamin D nor n-3 FA supplementation', 'vitamin D + n-3 FA (392), vitamin D (392), n-3 FA (392), or placebo', 'n-3 FA', 'vitamin D and marine ω-3 fatty acid (n-3 FA) supplements', 'vitamin D', 'Vitamin D']","['baseline serum 25(OH) vitamin D', 'IL-6', 'interleukin (IL)-6, tumor necrosis factor receptor 2 (TNFR2), and high-sensitivity C-reactive protein (hsCRP) concentrations']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0255813', 'cui_str': 'Receptors, Tumor Necrosis Factor, Type II'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",777.0,0.792985,Vitamin D resulted in 8.2% higher IL-6,"[{'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': 'Division of Rheumatology, Inflammation and Immunity, and kcostenbader@bwh.harvard.edu.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'MacFarlane', 'Affiliation': 'Division of Rheumatology, Inflammation and Immunity, and.'}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Kotler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]",Clinical chemistry,['10.1373/clinchem.2019.306902']
461,31701133,Learning Experience Reverses Catecholaminergic Effects on Adaptive Behavior.,"BACKGROUND
Catecholamines are important for cognitive control and the ability to adapt behavior (e.g., after response errors). A prominent drug that modulates the catecholaminergic system is methylphenidate. On the basis of theoretical consideration, we propose that the effects of methylphenidate on behavioral adaptation depend on prior learning experience.
METHODS
In a double-blind, randomized, placebo-controlled crossover study design, we examined the effect of methylphenidate (0.25 mg/kg) on post error behavioral adaptation processes in a group of n = 43 healthy young adults. Behavioral adaptation processes were examined in a working memory, modulated response selection task. The focus of the analysis was on order effects within the crossover study design to evaluate effects of prior learning/task experience.
RESULTS
The effect of methylphenidate/placebo on post-error behavioral adaptation processes reverses depending on prior task experience. When there was no prior experience with the task, methylphenidate increased post-error slowing and thus intensified behavioral adaptation processes. However, when there was prior task experience, (i.e., when the placebo session was conducted first in the crossover design), methylphenidate even decreased post-error slowing and behavioral adaptation. Effect sizes were large and the power of the observed effects was higher than 95%.
CONCLUSIONS
The data suggest that catecholaminergic effects on cognitive control functions vary as a function of prior learning/task experience. The data establish a close link between learning/task familiarization and catecholaminergic effects for executive functions, which has not yet been studied, to our knowledge, but is of considerable clinical relevance. Theoretical implications are discussed.",2020,"When there was no prior experience with the task, MPH increased post-error slowing and thus intensified behavioral adaptation processes.",['a group of N = 43 healthy young adults'],"['placebo', 'MPH', 'MPH/placebo']","['Behavioral adaptation processes', 'cognitive control functions']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048853', 'cui_str': 'MPH'}]","[{'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",43.0,0.0947895,"When there was no prior experience with the task, MPH increased post-error slowing and thus intensified behavioral adaptation processes.","[{'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Mückschel', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Eggert', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Prochnow', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Beste', 'Affiliation': 'Cognitive Neurophysiology, Department of Child and Adolescent Psychiatry, Faculty of Medicine, TU Dresden, Dresden, Germany.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyz058']
462,31309333,"Probiotics for chronic low back pain with type 1 Modic changes: a randomized double-blind, placebo-controlled trial with 1-year follow-up using Lactobacillus Rhamnosis GG.","PURPOSE
To investigate whether treatment by lactic acid bacteria for 100 days is associated with change of disability and pain in chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up.
METHODS
Eighty-nine patients with CLBP and type 1 MC or mixed MC were randomized to receive either one capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100 days.
RESULTS
Missing values at 1 year were 4% and 3% in the disability and pain variables, respectively. The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups. At 1 year, back pain had on average decreased by 1.1 more on a 0-10 scale (95% confidence interval 0.20-1.97) in the group treated by lactic acid bacteria than in the control group. There were no differences regarding other predefined outcomes, i.e. global effect or percentage with minimal disability at 1 year. Nine per cent of the patients reported gastrointestinal side effects without difference between groups.
CONCLUSIONS
No differences were found regarding the predefined outcomes. Overall, there was little improvement during the 1-year observation period. A small, though hardly clinically relevant, effect on back pain was seen after treatment by Lactobacillus Rhamnosis GG, and the treatment was without side effects in comparison with the control group.",2019,The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups.,"['Eighty-nine patients with CLBP and type 1 MC or mixed MC', 'chronic low back pain with type 1 Modic changes', 'chronic low back pain (CLBP) patients with type 1 or mixed Modic changes (MC) during 1-year follow-up']","['lactic acid bacteria', 'capsule Lactobacillus Rhamnosis GG (6 billion colony-forming unit per capsule) twice daily or placebo capsules for 100\xa0days', 'placebo', 'Probiotics']","['outcomes disability and back\u2009+\u2009leg pain', 'global effect or percentage with minimal disability', 'gastrointestinal side effects', 'back pain']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1210581', 'cui_str': 'Lactic Acid Bacteria'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",89.0,0.459244,The predefined outcomes disability and back + leg pain only changed little during follow-up with no statistically significant differences between groups.,"[{'ForeName': 'Ole K', 'Initials': 'OK', 'LastName': 'Jensen', 'Affiliation': 'Spine Center, Research Unit, University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Andersen', 'Affiliation': 'University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'René D', 'Initials': 'RD', 'LastName': 'Østgård', 'Affiliation': 'University Research Clinic for Innovative Patient Pathways, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Niels T', 'Initials': 'NT', 'LastName': 'Andersen', 'Affiliation': 'Department of Biostatistics, University of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'DEFACTUM, Central Denmark Region, Aarhus, Denmark.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06046-6']
463,31016337,Stabilization exercise affects function of transverse abdominis and pelvic floor muscles in women with postpartum lumbo-pelvic pain: a double-blinded randomized clinical trial study.,"INTRODUCTION AND HYPOTHESIS
Lumbo-pelvic pain (LPP) is a common disorder in women after pregnancy due to ligament laxity and postural changes. Transverse abdominis (TrA) and pelvic floor muscle (PFM) activity is important for lumbo-pelvic stability. The purpose of this study was to compare the effect of stabilization exercise (SE) and general exercise (GE) on TrA and PFM muscle activity and pain intensity in women with postpartum LPP.
METHODS
A randomized controlled trial study was conducted on 68 women with postpartum LPP. Patients were randomly divided into two groups of stabilization exercise (SE) and general exercise (GE) and received either SE or GE exercise for 8 weeks three times a week. Ultrasound imaging was utilized to measure the thickness change of TrA muscles during abdominal hollowing (AH) and bladder base displacement. These measurements were used as an indicator of TrA and PFM muscle activity. Pain intensity, thickness changes of the TrA muscle and bladder base displacement were measured pre- and post-intervention.
RESULTS
The results showed that there was no significant difference in pain relief after intervention between groups. The differences in TrA and PFM activity between groups were significant (P < 0.05). PFM and TrA muscle activity was significantly increased after SE in women with postpartum LPP (P < 0.05).
CONCLUSIONS
SE improved both PFM and TrA muscle function more than GE in women with postpartum LPP. However, the clinical outcome of pain relief was not greater in the SE group.",2020,"PFM and TrA muscle activity was significantly increased after SE in women with postpartum LPP (P < 0.05).
","['women after pregnancy due to ligament laxity and postural changes', 'women with postpartum LPP', 'women with postpartum lumbo-pelvic pain', '68 women with postpartum LPP']","['stabilization exercise (SE) and general exercise (GE', 'Stabilization exercise', 'stabilization exercise (SE) and general exercise (GE) and received either SE or GE exercise']","['Transverse abdominis (TrA) and pelvic floor muscle (PFM) activity', 'PFM and TrA muscle activity', 'TrA and PFM activity', 'Pain intensity, thickness changes of the TrA muscle and bladder base displacement', 'TrA and PFM muscle activity and pain intensity', 'transverse abdominis and pelvic floor muscles', 'PFM and TrA muscle function', 'pain relief']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0158359', 'cui_str': 'Laxity of ligament (disorder)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",68.0,0.0719592,"PFM and TrA muscle activity was significantly increased after SE in women with postpartum LPP (P < 0.05).
","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Sahebi', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Shanbehzadeh', 'Affiliation': 'Rehabilitation Research Center, Iran University of Medical Sciences, Tehran, Iran. sanaz_shan@yahoo.com.'}, {'ForeName': 'Amir Massoud', 'Initials': 'AM', 'LastName': 'Arab', 'Affiliation': 'Department of Physical Therapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'ShahAli', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}]",International urogynecology journal,['10.1007/s00192-019-03877-1']
464,31582195,Negative Emotions and the Course of Depression During Psychotherapy in Suicidal Older Adults With Depression and Cognitive Impairment.,"OBJECTIVE
The study examines the relationship of negative emotions with: 1) non-emotional symptoms (e.g., vegetative and physical symptoms) and 2) the course of depression in suicidal older adults with Major Depressive Disorder (MDD) and cognitive impairment treated with psychotherapy.
DESIGN
The authors identified a subgroup of participants (N = 26) who expressed suicidal ideation at Baseline or Week 12 from a randomized controlled trial (RCT) of two psychosocial interventions, Problem Adaptation Therapy (PATH) and Supportive Therapy for Cognitively Impaired. The authors assessed negative emotions, non-emotional symptoms of depression, depression severity, and suicidal ideation at entry, week 4, week 8, and week 12.
PARTICIPANTS
Participants were 65 years and older and had a diagnosis of unipolar depression, varying degrees of cognitive impairment (up to moderate dementia) and suicidal ideation.
SETTING
The study was conducted in the Outpatient Department of New York Presbyterian/Weill Cornell Medicine in Westchester, NY.
MEASUREMENTS
Negative emotions and non-emotional items were identified with the 24-item Hamilton Depression Rating Scale (Ham-D).
RESULTS
Among participants with suicidal ideation, the reduction in negative emotions from baseline to week 4, week 4 to week 8, and week 8 to week 12 was significantly associated with the reduction in non-emotional symptoms of depression at weeks 4, 8, and 12 (F (1, 35) = 6.20, p = 0.02) and with the reduction in overall depression severity at weeks 4, 8, and 12 (F (1, 35) = 26.63, p <0.0001) after controlling for depression severity at baseline (HAM-D total score) and time trends.
CONCLUSION
Our findings may guide the treatment of older patients with depression and suicidal ideation to help reduce depression and suicide risk.",2019,"Among participants with suicidal ideation, the reduction in negative emotions from baseline to week 4, week 4 to week 8, and week 8 to week 12 was significantly associated with the reduction in non-emotional symptoms of depression at weeks 4, 8, and 12 (F (1, 35) = 6.20, p = 0.02) and with the reduction in overall depression severity at weeks 4, 8, and 12 (F (1, 35) = 26.63, p <0.0001) after controlling for depression severity at baseline (HAM-D total score) and time trends.
","['The study was conducted in the Outpatient Department of New York Presbyterian/Weill Cornell Medicine in Westchester, NY', 'participants with suicidal ideation', 'older patients with depression and suicidal ideation', 'Suicidal Older Adults With Depression and Cognitive Impairment', 'subgroup of participants (N\u202f=\u202f26) who expressed suicidal ideation at Baseline or Week 12 from a randomized controlled trial (RCT) of two', 'Participants were 65 years and older and had a diagnosis of unipolar depression, varying degrees of cognitive impairment (up to moderate dementia) and suicidal ideation', 'suicidal older adults with Major Depressive Disorder (MDD) and cognitive impairment treated with psychotherapy']","['psychosocial interventions, Problem Adaptation Therapy (PATH) and Supportive Therapy']","['negative emotions, non-emotional symptoms of depression, depression severity, and suicidal ideation', 'negative emotions', '24-item Hamilton Depression Rating Scale (Ham-D', 'Negative emotions and non-emotional items', 'Negative Emotions', 'overall depression severity', 'non-emotional symptoms of depression']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0337749', 'cui_str': 'Presbyterians'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C3494871', 'cui_str': 'Moderate dementia'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0356555,"Among participants with suicidal ideation, the reduction in negative emotions from baseline to week 4, week 4 to week 8, and week 8 to week 12 was significantly associated with the reduction in non-emotional symptoms of depression at weeks 4, 8, and 12 (F (1, 35) = 6.20, p = 0.02) and with the reduction in overall depression severity at weeks 4, 8, and 12 (F (1, 35) = 26.63, p <0.0001) after controlling for depression severity at baseline (HAM-D total score) and time trends.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Arslanoglou', 'Affiliation': 'Weill-Cornell Institute of Geriatric Psychiatry (EA, SB, JP, LE, DNK), Weill Cornell Medicine, White Plains, NY.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Weill-Cornell Institute of Geriatric Psychiatry (EA, SB, JP, LE, DNK), Weill Cornell Medicine, White Plains, NY.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pantelides', 'Affiliation': 'Weill-Cornell Institute of Geriatric Psychiatry (EA, SB, JP, LE, DNK), Weill Cornell Medicine, White Plains, NY.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Weill-Cornell Institute of Geriatric Psychiatry (EA, SB, JP, LE, DNK), Weill Cornell Medicine, White Plains, NY.'}, {'ForeName': 'Dimitris N', 'Initials': 'DN', 'LastName': 'Kiosses', 'Affiliation': 'Weill-Cornell Institute of Geriatric Psychiatry (EA, SB, JP, LE, DNK), Weill Cornell Medicine, White Plains, NY. Electronic address: dkiosses@med.cornell.edu.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2019.08.018']
465,32156788,Patient-Ventilator Interaction During Noninvasive Ventilation in Subjects With Exacerbation of COPD: Effect of Support Level and Ventilator Mode.,"BACKGROUND
Patient-ventilator synchrony in patients with COPD is at risk during noninvasive ventilation (NIV). NIV in neurally-adjusted ventilatory assist (NAVA) mode improves synchrony compared to pressure support ventilation (PSV). The current study investigated patient-ventilator interaction at 2 levels of NAVA and PSV mode in subjects with COPD exacerbation.
METHODS
NIV was randomly applied at 2 levels (5 and 15 cm H 2 O) of PSV and NAVA. Patient-ventilator interaction was evaluated by comparing airway pressure and electrical activity of the diaphragm waveforms with automated computer algorithms.
RESULTS
8 subjects were included. Trigger delay was longer in PSV high (268 ± 112 ms) than in PSV low (161 ± 118 ms, P = .043), and trigger delay during NAVA was shorter than PSV for both low support (49 ± 24 ms for NAVA, P = .035) and high support (79 ± 276 ms for NAVA, P = .003). No difference in cycling error for low and high levels of PSV (PSV low -100 ± 114 ms and PSV high 56 ± 315 ms) or NAVA (NAVA low -5 ± 18 ms, NAVA high 12 ± 36 ms) and no difference between PSV and NAVA was found.
CONCLUSIONS
Increasing PSV levels during NIV caused a progressive mismatch between neural effort and pneumatic timing. Patient-ventilator interaction during NAVA was more synchronous than during PSV, independent of inspiratory support level. (ClinicalTrials.gov registration NCT01791335.).",2020,"Trigger delay was longer in PSV high (268 ± 112 ms) than in PSV low (161 ± 118 ms, P = .043), and trigger delay during NAVA was shorter than PSV for both low support (49 ± 24 ms for NAVA, P = .035) and high support (79 ± 276 ms for NAVA, P = .003).","['patients with COPD is at risk during noninvasive ventilation (NIV', 'Subjects With Exacerbation of COPD', 'subjects with COPD exacerbation', '8 subjects were included']",['Support Level and Ventilator Mode'],"['cycling error for low and high levels of PSV', 'trigger delay during NAVA', 'Patient-Ventilator Interaction', 'Trigger delay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",8.0,0.0449654,"Trigger delay was longer in PSV high (268 ± 112 ms) than in PSV low (161 ± 118 ms, P = .043), and trigger delay during NAVA was shorter than PSV for both low support (49 ± 24 ms for NAVA, P = .035) and high support (79 ± 276 ms for NAVA, P = .003).","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Oppersma', 'Affiliation': 'Cardiovascular and Respiratory Physiology, Faculty of Science and Technology, University of Twente, Enschede, The Netherlands. e.oppersma@utwente.nl.'}, {'ForeName': 'Jonne', 'Initials': 'J', 'LastName': 'Doorduin', 'Affiliation': 'Department of Intensive Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lisanne H', 'Initials': 'LH', 'LastName': 'Roesthuis', 'Affiliation': 'Department of Intensive Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Veltink', 'Affiliation': 'Biomedical Signals and Systems, Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Leo Ma', 'Initials': 'LM', 'LastName': 'Heunks', 'Affiliation': 'Department of Intensive Care, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",Respiratory care,['10.4187/respcare.07159']
466,31398376,"Change in self-efficacy, eating behaviors and food cravings during two years of calorie restriction in humans without obesity.","Calorie restriction (CR) enhances longevity in humans who are normal weight, overweight and obese. While dietary regimens can change self-efficacy, eating behaviors, and food cravings in individuals with obesity, the responses of these measures to prolonged CR in individuals who are exclusively not obese is unknown. The aim of this analysis was to test the effects of a two-year CR intervention on self-efficacy and eating attitudes and behaviors in humans without obesity by analyzing data from the Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy Phase 2 (CALERIE 2) study. Participants (n = 218, BMI range = 21.3-29.0 kg/m 2 ) were randomized to a 25% CR group or an ad libitum (AL) group. Eating attitudes and behaviors and self-efficacy were assessed using validated questionnaires at baseline, month 12, and month 24. Dietary restraint and self-efficacy increased in the CR compared to the AL group (ES ≥ 0.32). Increased self-efficacy was negatively related to weight change (ρ < -0.24). In the CR group, males showed a reduction in cravings for carbohydrates and fats at month 24, whereas females did not. The CR group showed elevations in state hunger, which were transient, and disinhibited eating (ES ≥ 0.37). In individuals without obesity, dietary restraint and self-efficacy could be important in promoting long-term CR for individuals looking to use CR as a tool to improve longevity.",2019,Dietary restraint and self-efficacy increased in the CR compared to the AL group (ES ≥ 0.32).,"['humans who are normal weight, overweight and obese', 'Participants (n\u202f=\u202f218, BMI range\u202f=\u202f21.3-29.0\u202fkg/m 2 ', 'humans without obesity', 'individuals with obesity']","['two-year CR intervention', 'CR group or an ad libitum (AL', 'Calorie restriction (CR']","['Increased self-efficacy', 'Dietary restraint and self-efficacy', 'Eating attitudes and behaviors and self-efficacy', 'change self-efficacy, eating behaviors, and food cravings', 'weight change', 'self-efficacy and eating attitudes and behaviors', 'self-efficacy, eating behaviors and food cravings', 'cravings for carbohydrates and fats']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",,0.0246942,Dietary restraint and self-efficacy increased in the CR compared to the AL group (ES ≥ 0.32).,"[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Manjushri', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Jean Mayer, US Department of Agriculture, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'S Nicole', 'Initials': 'SN', 'LastName': 'Fearnbach', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Candice A', 'Initials': 'CA', 'LastName': 'Myers', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Tiffany M', 'Initials': 'TM', 'LastName': 'Stewart', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA, USA. Electronic address: Corby.Martin@pbrc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Appetite,['10.1016/j.appet.2019.104397']
467,30904934,Anesthetics' role in postoperative urinary retention after pelvic organ prolapse surgery with concomitant midurethral slings: a randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS
Spinal anesthesia can be a potential risk factor for postoperative urinary retention (POUR). Our objective was to compare POUR rates for outpatient vaginal pelvic floor surgeries when using spinal versus general anesthesia. Our hypothesis was that spinal anesthesia would have higher POUR rates compared with general anesthesia.
METHODS
This was a randomized clinical trial on subjects undergoing outpatient pelvic organ prolapse (POP) surgery with a concomitant midurethral sling (MUS). Subjects were discharged home the same day as surgery. Subjects were excluded if they had a preoperative post-void residual > 150 ml, they were < 40 years of age, surgery was < 1 h, or they had contraindications to spinal or general anesthesia. A standardized voiding trial was performed. The primary aim was to compare POUR rates between anesthesia groups. A power analysis estimated 28 subjects were required per group to detect a 37% difference with 80% power and an alpha of 0.05.
RESULTS
The trial was registered at ClinicalTrials.gov on July 15, 2015. Sixty-one subjects were enrolled between June 22, 2015, and December 31, 2017. Three were excluded, leaving 29 in each group. Groups were similar in demographics. For the primary outcome, there was a 14.3% difference in POUR rates between spinal and general anesthesia, which did not reach statistical significance based on our power calculation (p = 0.2516).
CONCLUSIONS
Based on this study, there is not an increased rate of POUR with the use of spinal anesthesia for POP surgery with MUS. However, since there was a trend toward higher rates of POUR in the spinal group, it is possible that a larger powered study design would be able to detect a statistically significant difference between the groups. Based on these findings, if surgical patients would benefit from spinal anesthesia, the risk of urinary retention should not be considered a reason to not utilize this form of anesthesia.
CLINICAL TRIAL REGISTRATION
Does spinal anesthesia for prolapse surgery with concomitant sling lead to an increase in urinary retention compared to general anesthesia? https://clinicaltrials.gov/ct2/show/NCT02547155?term=laura+martin&rank=3 (NCT02547155).",2020,"CLINICAL TRIAL REGISTRATION
Does spinal anesthesia for prolapse surgery with concomitant sling lead to an increase in urinary retention compared to general anesthesia?","['subjects undergoing outpatient pelvic organ prolapse (POP) surgery with a', 'postoperative urinary retention after pelvic organ prolapse surgery with concomitant midurethral slings', 'Subjects were excluded if they had a preoperative post-void residual ', '150\xa0ml, they were\u2009<\u200940\xa0years of age', 'Sixty-one subjects were enrolled between June 22, 2015, and December 31, 2017']",['concomitant midurethral sling (MUS'],"['POUR rates', 'rate of POUR', 'urinary retention', 'rates of POUR']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C0026809', 'cui_str': 'Mice'}]","[{'cui': 'C0080274', 'cui_str': 'Urinary Retention'}]",61.0,0.182592,"CLINICAL TRIAL REGISTRATION
Does spinal anesthesia for prolapse surgery with concomitant sling lead to an increase in urinary retention compared to general anesthesia?","[{'ForeName': 'Alexandriah', 'Initials': 'A', 'LastName': 'Alas', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, University of Texas Health San Antonio, 7703 Floyd Curl Dr, San Antonio, TX, 78229, USA. alas@uthscsa.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA.'}, {'ForeName': 'Hemikaa', 'Initials': 'H', 'LastName': 'Devakumar', 'Affiliation': 'Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Frank', 'Affiliation': 'Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Vaish', 'Affiliation': 'Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA.'}, {'ForeName': 'Neeraja', 'Initials': 'N', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA.'}, {'ForeName': 'G Willy', 'Initials': 'GW', 'LastName': 'Davila', 'Affiliation': 'Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hurtado', 'Affiliation': 'Department of Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Cleveland Clinic Florida, 2950 Cleveland Clinic Blvd, Weston, FL, 33331, USA.'}]",International urogynecology journal,['10.1007/s00192-019-03917-w']
468,32154732,Gender differences in the effectiveness of public education messages aimed at smartphone use among young drivers.,"Objective: The main aim of this survey study was to evaluate the relative persuasiveness of three newly developed and piloted public education messages aimed at monitoring/reading social interactive technology on a smartphone among young male and female drivers. In accordance with the Step Approach to Message Design and Testing, the messages were evaluated on a number of outcome measures and also explored the influence of self-reported involvement in the target behavior. Methods: Participants ( N = 152; 105 F) were aged 17 to 25 years ( M age = 20.14 years, SD = 2.35) and were randomly allocated to either an intervention (one of the three messages) or control (no message) condition. The messages in the intervention group were assessed on acceptance (i.e., behavioral intention and message effectiveness), rejection, and the third person effect (TPE) differential score (i.e., the message is perceived to be more effective for others than for themselves). Results: Hierarchical regression analyses found that, compared to males, females reported: a) lower intention to monitor/read social interactive technology on a smartphone while driving, b) lower rejection; and, c) lower TPE likelihood, irrespective of message. Conclusions: These findings suggest that young male drivers and young female drivers require different message content to be effective and support the importance of including multiple outcome measures to explain the messages' persuasive effects.",2020,"Results: Hierarchical regression analyses found that, compared to males, females reported: a) lower intention to monitor","['Participants ( N \u2009=\u2009152; 105\u2009F) were aged 17 to 25\u2009years ( M age = 20.14\u2009years, SD \u2009=\u20092.35', 'young male drivers and young female drivers', 'young male and female drivers', 'young drivers']",['piloted public education messages aimed at monitoring/reading social interactive technology'],"['acceptance (i.e., behavioral intention and message effectiveness), rejection, and the third person effect (TPE) differential score']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.043007,"Results: Hierarchical regression analyses found that, compared to males, females reported: a) lower intention to monitor","[{'ForeName': 'Cassandra S', 'Initials': 'CS', 'LastName': 'Gauld', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Ioni M', 'Initials': 'IM', 'LastName': 'Lewis', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'White', 'Affiliation': 'Institute of Health and Biomedical Innovation, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Barry C', 'Initials': 'BC', 'LastName': 'Watson', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Chae T', 'Initials': 'CT', 'LastName': 'Rose', 'Affiliation': 'Centre for Accident Research and Road Safety, Queensland University of Technology, Queensland, Australia.'}, {'ForeName': 'Judy J', 'Initials': 'JJ', 'LastName': 'Fleiter', 'Affiliation': 'School of Psychology and Counselling, Queensland University of Technology, Queensland, Australia.'}]",Traffic injury prevention,['10.1080/15389588.2020.1732948']
469,32154734,"Infant car seat use in Japan after the antepartum distribution of an educational leaflet: A prospective, nonrandomized controlled trial with a questionnaire survey.","Objective: To determine whether an antepartum educational leaflet distributed to parents before infant delivery affected the rate of infant car-seat (ICS) use 1 month after delivery, because to the best of our knowledge, only few reports have evaluated systematic attempts to improve the rate of always ICS use by mothers driving infants Methods: A multicenter questionnaire survey targeting pregnant Japanese women seeking antenatal care at the outpatient clinics of eight hospitals was designed. Women enrolled during the first half of the study period did not receive leaflets describing ICS safety guidelines (control group). Women enrolled during the latter half of the study period received the leaflet between gestational week 35 and 37 (intervention group). All women were requested to anonymously respond to the questionnaires within 1 month postpartum. The rates of ICS use, position, and direction after delivery were compared between both groups. Results: Of the 3534 women who responded to the questionnaire survey (response rate, 81.9%), 1772 women (50.1%) were assigned to the intervention group and 1762 (49.9%) women to the control group. The rates of ICS attachments (86.8% vs. 82.4% in the intervention and control groups, respectively, p = 0.0003), always ICS use (80.5% vs. 76.2%, respectively, p = 0.0019), ICS placement on the rear seat (78.6% vs. 74.1%, respectively, p = 0.0020), and ICS placement in a rear-facing position (62.2% vs. 56.7%, respectively, p = 0.0008) were significantly higher in the intervention group than those in the control group. The motor vehicle accident (MVA) rates within 1 month postpartum were similar between the intervention and control groups (0.51% vs. 0.57%, respectively, p = 0.8229). Conclusions: Antepartum minimal intervention via the distribution of an educational leaflet recommending ICS safety guidelines was associated with increased rates of ICS attachments, always ICS use, and ICS placement on the rear seat and in rear-facing positions; however, it did not contribute to reduced MVA rates after delivery.",2020,"The rates of ICS attachments (86.8% vs. 82.4% in the intervention and control groups, respectively, p = 0.0003), always ICS use (80.5% vs. 76.2%, respectively, p = 0.0019), ICS placement on the rear seat (78.6% vs. 74.1%, respectively, p = 0.0020), and ICS placement in a rear-facing position (62.2% vs. 56.7%, respectively, p = 0.0008) were significantly higher in the intervention group than those in the control group.","['Women enrolled during the first half of the study period did not receive leaflets describing ICS safety guidelines (control group', 'pregnant Japanese women seeking antenatal care at the outpatient clinics of eight hospitals was designed', '3534 women who responded to the questionnaire survey (response rate, 81.9', '1772 women (50.1%) were assigned to the intervention group and 1762 (49.9%) women to the control group']",[],"['ICS placement on the rear seat', 'MVA rates', 'rates of ICS attachments', 'motor vehicle accident (MVA) rates', 'rates of ICS attachments, always ICS use, and ICS placement', 'always ICS use', 'rates of ICS use, position, and direction after delivery']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1283233', 'cui_str': 'Seating'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",3534.0,0.0386861,"The rates of ICS attachments (86.8% vs. 82.4% in the intervention and control groups, respectively, p = 0.0003), always ICS use (80.5% vs. 76.2%, respectively, p = 0.0019), ICS placement on the rear seat (78.6% vs. 74.1%, respectively, p = 0.0020), and ICS placement in a rear-facing position (62.2% vs. 56.7%, respectively, p = 0.0008) were significantly higher in the intervention group than those in the control group.","[{'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Morikawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Obstetrics and Gynecology, JCHO Hokkaido Hospital, Sapporo, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Kogo', 'Affiliation': ""Department of Obstetrics and Gynecology, Sapporo Maternity Women's Hospital, Sapporo, Japan.""}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Sugawara', 'Affiliation': 'Department of Obstetrics and Gynecology, Sapporo Toho Hospital, Sapporo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Obstetrics and Gynecology, NTT East Japan Sapporo General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Fukushi', 'Affiliation': 'Department of Obstetrics and Gynecology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Kato-Hirayama', 'Affiliation': 'Department of Obstetrics and Gynecology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Ishioka', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Sapporo Medical University, Sapporo, Japan.'}, {'ForeName': 'Hidemichi', 'Initials': 'H', 'LastName': 'Watari', 'Affiliation': 'Department of Obstetrics and Gynecology, Hokkaido University Graduate School of Medicine, Sapporo, Japan.'}]",Traffic injury prevention,['10.1080/15389588.2020.1733540']
470,32159243,Peer mentorship as an adjunct intervention for the treatment of eating disorders: A pilot randomized trial.,"OBJECTIVE
Peer mentorship has been shown to be helpful for other mental health conditions, but it has been understudied for patients with eating disorders. The goal of the present study was to evaluate the feasibility and efficacy of peer mentorship for individuals with eating disorders by conducting a randomized controlled trial (RCT).
TRIAL DESIGN
Parallel three-arm pilot RCT with 1:1:1 allocation to peer mentorship, social support mentorship (active comparison intervention), and waiting list.
METHOD
Sixty outpatients with anorexia nervosa (AN), bulimia nervosa (BN), or binge-eating disorder (BED) were randomly assigned to a condition. Outcome measures, including eating disorder symptoms and general psychopathology, were completed at baseline, mid-, and postintervention.
RESULTS
Session attendance and acceptability ratings were higher in peer mentorship than social support mentorship. More participants in social support mentorship (39%) dropped out compared to peer mentorship (5%). In intent-to-treat analysis, peer mentorship showed greater reductions in body dissatisfaction and anxiety compared with both control groups. Compared with social support mentorship, peer mentorship had greater reductions in depression. Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN. Peer mentorship did not impact body mass index or reentry into higher level of care.
DISCUSSION
This pilot RCT provides preliminary evidence that peer mentorship is effective for some cognitive and behavioral symptoms of eating disorders as an adjunct to outpatient treatment. Additional studies are needed to evaluate the efficacy of peer mentorship in absence of treatment.",2020,"Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN.","['eating disorders', 'patients with eating disorders', 'Sixty outpatients with anorexia nervosa (AN), bulimia nervosa (BN), or binge-eating disorder (BED', 'individuals with eating disorders']","['social support mentorship', 'peer mentorship, social support mentorship (active comparison intervention), and waiting list', 'peer mentorship', 'Peer mentorship', 'social support mentorship, peer mentorship']","['acceptability ratings', 'eating disorder symptoms and general psychopathology', 'body dissatisfaction and anxiety', 'binge eating days', 'feasibility and efficacy', 'depression']","[{'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0037438'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",60.0,0.0469861,"Compared with waiting list, peer mentorship had greater reduction in binge eating days/week in patients with BN/BED and restriction days/week in patients with AN.","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Ranzenhofer', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Mylene', 'Initials': 'M', 'LastName': 'Wilhelmy', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Annabella', 'Initials': 'A', 'LastName': 'Hochschild', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Sanzone', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'B Timothy', 'Initials': 'BT', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Attia', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23258']
471,31275080,A Preliminary Examination of the Effect of Cognitive Processing Therapy on Sleep Disturbance Among Veterans with Military Sexual Trauma-Related Posttraumatic Stress Disorder.,"Veterans who have experienced military sexual trauma (MST) report numerous psychosocial difficulties including sleep disturbance and posttraumatic stress disorder (PTSD). Cognitive Processing Therapy (CPT) has been shown to effectively reduce total PTSD symptoms among veterans with MST-related PTSD; however, sleep disturbance may persist after successful treatment. Sleep disturbance is associated with suicidal self-directed violence, substance use, and poorer physical health. Identification of if and when CPT can sufficiently address sleep disturbance may help to determine when adjunctive interventions may be indicated. The current study described the rate of sleep disturbance in a sample of veterans with MST-related PTSD before and after CPT. In an exploratory analysis, potential baseline predictors (i.e., sociodemographic, PTSD symptoms, trauma-related cognitions, depression, physical health) of change in sleep disturbance following CPT were assessed. A secondary analysis of 72 male and female veterans enrolled in a randomized clinical trial examining the efficacy of CPT for MST-related PTSD was conducted. Most veterans reported clinically significant sleep disturbance at baseline (100%) and post-treatment (89%). A significant relationship between clinically significant change in PTSD symptoms and resolution of sleep disturbance was not identified. Using hierarchical multiple linear regression, potential predictors of change in sleep severity following CPT were assessed; however, no significant predictors were identified in this exploratory analysis. These results are consistent with previous research describing high residual rates of sleep disturbance in veterans with PTSD, despite reductions in overall PTSD symptoms. Future research should focus on identifying effective augmentation strategies for CPT to specifically address sleep disturbance.",2019,Most veterans reported clinically significant sleep disturbance at baseline (100%) and post-treatment (89%).,"['veterans with PTSD', 'veterans with MST-related PTSD', 'Veterans with Military Sexual Trauma-Related Posttraumatic Stress Disorder', '72 male and female veterans', 'Veterans who have experienced military sexual trauma (MST) report numerous psychosocial difficulties including sleep disturbance and posttraumatic stress disorder (PTSD', 'sample of veterans with MST-related PTSD before and after CPT']","['Cognitive Processing Therapy (CPT', 'CPT', 'Cognitive Processing Therapy']","['Sleep Disturbance', 'sleep disturbance', 'PTSD symptoms and resolution of sleep disturbance', 'total PTSD symptoms', 'rate of sleep disturbance', 'Sleep disturbance', 'sociodemographic, PTSD symptoms, trauma-related cognitions, depression, physical health) of change in sleep disturbance', 'overall PTSD symptoms']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}]","[{'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",72.0,0.0137541,Most veterans reported clinically significant sleep disturbance at baseline (100%) and post-treatment (89%).,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Holder', 'Affiliation': 'Veterans Affairs North Texas Health Care System.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Holliday', 'Affiliation': 'Rocky Mountain Mental Illness, Education, and Clinical Center for Suicide Prevention.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Wiblin', 'Affiliation': 'Veterans Affairs North Texas Health Care System.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Surís', 'Affiliation': 'Veterans Affairs North Texas Health Care System.'}]",Traumatology,['10.1037/trm0000196']
472,31409568,Radiofrequency Ablation Duration per Tumor Volume May Correlate with Overall Survival in Solitary Hepatocellular Carcinoma Patients Treated with Radiofrequency Ablation Plus Lyso-Thermosensitive Liposomal Doxorubicin.,"PURPOSE
To determine whether burn time per tumor volume (BPV) (min/mL), where burn time is the total time during which radiofrequency (RF) energy is being applied, is correlated with hepatocellular carcinoma (HCC) treatment outcomes using RF ablation and lyso-thermosensitive liposomal doxorubicin (LTLD).
MATERIALS AND METHODS
The HEAT study was a double-blind, randomized controlled phase III trial of RF ablation only versus RF ablation + LTLD in patients with HCCs 3-7 cm in diameter. Effect of BPV on progression-free survival and overall survival (OS) was analyzed.
RESULTS
BPV demonstrated statistically significant differences between study groups for OS (P = .038, hazard ratio [HR] = 0.85), but not for progression-free survival (P = .389, HR = 1.059). In a separate analysis, treatment groups were independently analyzed to determine the effect of BPV within each individual group. OS improved as BPV increased for patients receiving RF ablation + LTLD (P = .017, HR = 0.836, confidence interval [0.722, 0.968]). This same association was not observed in patients receiving RF ablation only (P = .57, HR = 0.99).
CONCLUSIONS
BPV may be a useful metric for RF ablation + LTLD combination therapy for solitary HCC. The analysis suggested that the burn time for the tumor needs to be adjusted depending on the tumor volume. Because this is a post hoc study, the results are only suggestive and need to be confirmed with prospective studies.",2019,"OS improved as BPV increased for patients receiving RF ablation + LTLD (P = .017, HR = 0.836, confidence interval [0.722, 0.968]).","['patients with HCCs 3-7 cm in diameter', 'Solitary Hepatocellular Carcinoma Patients']","['RF ablation and lyso-thermosensitive liposomal doxorubicin (LTLD', 'RF Ablation Plus Lyso-thermosensitive Liposomal Doxorubicin', 'RF ablation', 'RF ablation\xa0+ LTLD', 'BPV', 'Radiofrequency Ablation Duration per Tumor Volume']","['BPV', 'progression-free survival and overall survival (OS', 'progression-free survival', 'Overall Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}]","[{'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0779831,"OS improved as BPV increased for patients receiving RF ablation + LTLD (P = .017, HR = 0.836, confidence interval [0.722, 0.968]).","[{'ForeName': 'Haydar', 'Initials': 'H', 'LastName': 'Celik', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892. Electronic address: haydar.celik@nih.gov.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Wakim', 'Affiliation': 'Biostatistics and Clinical Epidemiology Service, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pritchard', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'Meryll', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Karanian', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Dewhirst', 'Affiliation': 'Duke Cancer Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Lencioni', 'Affiliation': 'Division of Diagnostic Imaging and Intervention, Pisa University School of Medicine, Pisa, Italy.'}, {'ForeName': 'Bradford J', 'Initials': 'BJ', 'LastName': 'Wood', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, 9000 Rockville Pike, Building 10, Room 3N320, Bethesda, MD 20892.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2019.04.023']
473,32156580,An occupation-based intervention in patients with hand-related disorders grouped using the sense of coherence scale-A randomized controlled trial.,"STUDY DESIGN
A nonblinded randomized controlled trial.
INTRODUCTION
Occupation-based interventions are superior to physical exercise-based interventions in patients with activity limitations. However, only a few studies have examined the effect in patients with hand-related disorders. Patients recover heterogeneously, which could be due to personal factors, such as sense of coherence (SOC).
PURPOSE OF THE STUDY
To investigate the effectiveness of an occupation-based intervention for patients with hand-related disorders and whether SOC can give an indication of the expected effects.
METHODS
A total of 504 patients were stratified into three SOC groups and then randomized to either an occupation-based intervention, including physical exercises (OBI) or a physical exercise-based occupation-focused intervention. The primary outcome, functioning, was measured using the Disability of the Arm, Shoulder and Hand questionnaire. Primary endpoint was at three months. Patients were followed up for a year.
RESULTS
No significant difference was found in primary outcome analysis. Nevertheless, patients receiving OBI had a statistically significant and greater change in satisfaction with their occupational performance at one, two, and three months follow-up. Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.
CONCLUSIONS
OBI as delivered in this study was not superior to physical exercise-based occupation-focused intervention in this patient group. However, in taking a client-centered approach, we recommend that OBI be based on individual needs, given that patients had a statistically greater change in score regarding satisfaction with their occupational performance. It is evident that patients with a weaker SOC have a lower level of functioning. This knowledge should inform clinical practice.",2020,"Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.
","['patients with a weaker SOC', 'patients with hand-related disorders', '504 patients', 'patients with activity limitations', 'patients with hand-related disorders and whether SOC']","['occupation-based intervention, including physical exercises (OBI) or a physical exercise-based occupation-focused intervention', 'occupation-based intervention', 'Occupation-based interventions are superior to physical exercise-based interventions']","['worse functioning and lower health-related quality of life', 'Disability of the Arm, Shoulder and Hand questionnaire', 'satisfaction with their occupational performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]","[{'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",504.0,0.0820637,"Patients with a weak SOC had worse functioning and lower health-related quality of life than those in the other groups, at all times.
","[{'ForeName': 'Alice Ørts', 'Initials': 'AØ', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; Department of Orthopaedic Surgery, Odense University Hospital, Odense C, Denmark; Department of Rehabilitation, Odense University Hospital, Odense C, Denmark. Electronic address: alice.oerts@rsyd.dk.'}, {'ForeName': 'Hanne Kaae', 'Initials': 'HK', 'LastName': 'Kristensen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; Department of Rehabilitation, Odense University Hospital, Odense C, Denmark; Health Sciences Research Center, University College Lillebaelt, Odense M, Denmark.'}, {'ForeName': 'Ragnhild', 'Initials': 'R', 'LastName': 'Cederlund', 'Affiliation': 'Health Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; OPEN - Odense Patient data Explorative Network, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tromborg', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense C, Denmark; Department of Orthopaedic Surgery, Odense University Hospital, Odense C, Denmark.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.12.009']
474,32067256,"Effect of ciclosporin on safety, lymphocyte kinetics and left ventricular remodelling in acute myocardial infarction.","AIMS
Following a favourable pilot trial using a single bolus of ciclosporin, it has been unclear why 2 large studies (CYCLE and CIRCUS) failed to prevent reperfusion injury and reduce infarct size in STEMI (ST elevation myocardial infarction). The purpose of this study was to assess the effect of ciclosporin on myocardial injury, left ventricular remodelling and lymphocyte kinetics in patients with acute STEMI undergoing primary percutaneous coronary intervention.
METHODS
In this double-blind, single centre trial, we randomly assigned 52 acute STEMI patients with an onset of pain of <6 hours and blocked culprit artery to a single bolus of ciclosporin (n = 26) or placebo (n = 26, control group) prior to reperfusion by stent percutaneous coronary intervention. The primary endpoint was infarct size at 12 weeks.
RESULTS
Mean infarct size at 12 weeks was identical in both groups (9.1% [standard deviation= 7.0] vs 9.1% [standard deviation = 7.0], P = .99; 95% confidence interval for difference: -4.0 to 4.1). CD3 T-lymphocytes dropped to similar levels at 90 minutes (867 vs 852 cells/μL, control vs ciclosporin) and increased to 1454 vs 1650 cells/μL at 24 hours.
CONCLUSION
In our pilot trial, a single ciclosporin bolus did not affect infarct size or left ventricular remodelling, matching the results from CYCLE and CIRCUS. Our study suggests that ciclosporin does either not reach ischaemic cardiomyocytes, or requires earlier application during first medical contact. Finally, 1 bolus of ciclosporin is not sufficient to inhibit CD4 T-lymphocyte proliferation during remodelling. We therefore believe that further studies are warranted. (Evaluating the effectiveness of intravenous Ciclosporin on reducing reperfusion injury in pAtients undergoing PRImary percutaneous coronary intervention [CAPRI]; NCT02390674).",2020,"CD3 T-lymphocytes dropped to similar levels at 90 min (867 vs 852 cells/ul, control vs ciclosporin) and increased to 1454 vs 1650 cells/ul at 24h.
","['pAtients undergoing PRImary percutaneous coronary intervention [CAPRI', 'acute myocardial infarction', '52 acute STEMI patients with an onset of pain of less than 6 hours and blocked culprit artery to a single bolus of', 'n=26) or', 'patients with acute STEMI undergoing primary PCI']","['placebo', 'control group) prior to reperfusion by stent PCI', 'ciclosporin', 'Ciclosporin']","['Mean infarct size', 'infarct size at 12 weeks', 'safety, lymphocyte kinetics and left ventricular remodelling', 'infarct size or LV remodelling', 'CD3 T-lymphocytes', 'myocardial injury, LV-remodelling, and lymphocyte kinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301654', 'cui_str': 'Single bolus (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0600519', 'cui_str': 'Myocardial Remodeling, Ventricular'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",52.0,0.597496,"CD3 T-lymphocytes dropped to similar levels at 90 min (867 vs 852 cells/ul, control vs ciclosporin) and increased to 1454 vs 1650 cells/ul at 24h.
","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Cormack', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Mohammed', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Panahi', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Steel', 'Affiliation': 'Newcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle University, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chadwick', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, UK.'}, {'ForeName': 'Mohaned', 'Initials': 'M', 'LastName': 'Egred', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Stellos', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ioakim', 'Initials': 'I', 'LastName': 'Spyridopoulos', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/bcp.14252']
475,30068252,"Effect of a School-Based Activity Tracker, Companion Social Website, and Text Messaging Intervention on Exercise, Fitness, and Physical Activity Self-Efficacy of Middle School Students.","This study examined the effect of a 10-week activity tracker, companion social website, and text messaging intervention on body mass index (BMI), body fat percentage, physical fitness, and physical activity (PA) self-efficacy of children. Children ( n = 98) were assigned to one of three groups: activity tracker group, text messaging group, and activity tracker + text messaging group. Pre-/posttest fitness, BMI, PA self-efficacy, and body fat percentage were measured. The activity tracker group had a significant increase in fitness, no significant difference in PA self-efficacy, and an increase in body fat percentage and BMI ( p < .05). The text messaging group had a significant increase in BMI ( p < .05). The activity tracker + text messaging group had no significant differences in fitness, BMI, PA self-efficacy, or body fat percentage. This study gives no clear support to the hypothesis that use of activity trackers and a text messaging intervention have a positive effect on fitness, PA self-efficacy, or body fat percentage.",2020,"The activity tracker + text messaging group had no significant differences in fitness, BMI, PA self-efficacy, or body fat percentage.","['Children ( n = 98', 'Middle School Students']","['School-Based Activity Tracker, Companion Social Website, and Text Messaging Intervention', '10-week activity tracker, companion social website, and text messaging intervention', 'activity tracker group, text messaging group, and activity tracker + text messaging group']","['body fat percentage and BMI', 'BMI', 'fitness, PA self-efficacy, or body fat percentage', 'Pre-/posttest fitness, BMI, PA self-efficacy, and body fat percentage', 'PA self-efficacy', 'Self-Efficacy', 'Exercise, Fitness, and Physical Activity', 'body mass index (BMI), body fat percentage, physical fitness, and physical activity (PA) self-efficacy of children', 'fitness, BMI, PA self-efficacy, or body fat percentage']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0335343', 'cui_str': 'Companions'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",98.0,0.0117784,"The activity tracker + text messaging group had no significant differences in fitness, BMI, PA self-efficacy, or body fat percentage.","[{'ForeName': 'Alison F', 'Initials': 'AF', 'LastName': 'Pittman', 'Affiliation': 'College of Nursing, Texas A&M University, Bryan, TX, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840518791223']
476,31689640,Protective behavioral strategies predict alcohol-related problems among injured patients following a brief intervention.,"BACKGROUND
Alcohol protective behavioral strategies (PBS) have been proposed as mechanisms of change underlying interventions for reducing alcohol use and alcohol-related problems. Few studies have examined PBS use among non-college student populations and no study has examined PBS use among adult injured patients. The current study tested types of PBS as mediators of the effects of a brief motivational intervention (BMI) delivered in the trauma care setting on alcohol-related problems.
METHOD
Secondary data analyses were conducted using data from a multisite randomized controlled trial of brief intervention in the trauma care setting. The current study used data from a subset of participants who reported having consumed alcohol at least once at 3-month follow-up (N = 324). Following a baseline assessment, participants were assigned to either brief advice (BA; n = 107), BMI (n = 119), or BMI with a telephone booster (BMI + B; n = 98). Participants completed measures of PBS at 3-month follow-up and of alcohol-related problems at baseline and 6-month follow-up. A multiple mediation model was conducted to simultaneously test the mediation effects of types of PBS.
RESULTS
BMI and BMI + B relative to BA did not increase PBS use. However, more frequent use of certain types of PBS at 3-month follow-up were predictors of greater reductions in alcohol-related problems from baseline to 6-month follow-up. There were no statistically significant mediation effects.
CONCLUSIONS
The present study suggests that PBS use reduces alcohol-related problems among trauma patients and implications for future studies are discussed.",2019,"There were no statistically significant mediation effects.
","['injured patients following a brief intervention', 'adult injured patients', 'participants who reported having consumed alcohol at least once at 3-month follow-up (N\u202f=\u202f324']","['PBS', 'motivational intervention (BMI', 'Alcohol protective behavioral strategies (PBS']",['PBS'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]",[],324.0,0.0369062,"There were no statistically significant mediation effects.
","[{'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA; Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA. Electronic address: dkrichards2@utep.edu.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Pearson', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Boulevard Southeast MSC11-6280, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Osvaldo F', 'Initials': 'OF', 'LastName': 'Morera', 'Affiliation': 'Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA; Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.06.037']
477,31689641,A community pharmacy-led intervention for opioid medication misuse: A small-scale randomized clinical trial.,"BACKGROUND
Stemming the opioid epidemic requires testing novel interventions. Toward this goal, feasibility and acceptability of a Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention was examined along with its impact on medication misuse and concomitant health conditions.
METHODS
We conducted a two-group randomized trial in 2 community pharmacies. We screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index. Participants were assigned to standard medication counseling (SMC) or SMC + BMI-MTM (referred to as BMI-MTM herein). BMI-MTM consists of a pharmacist-led medication counseling/brief motivational session and 8-weekly patient navigation sessions. Assessments were at baseline, 2-, and 3-months. Primary outcomes included feasibility, acceptability, and mitigation of opioid medication misuse. Secondary outcomes included pain and depression. Outcomes were analyzed with descriptive and multivariable statistics (intent-to-treat [ITT] and adjusted for number of sessions completed [NUMSESS]).
RESULTS
Thirty-two participants provided informed consent (74.4% consent rate; SMC n = 17, BMI-MTM n = 15; 3-month assessment retention ≥93%). Feasibility was demonstrated by all BMI-MTM recipients completing the pharmacist session and an average of 7 navigation sessions. BMI-MTM recipients indicated ≥4.2 (5 maximum) level of satisfaction with the pharmacist-led session, and 92.4% were satisfied with navigation sessions. Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001.
NUMSESS
AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = 14.0, 95% CI = 3.28, 24.8, p = 0.01), and depression (ITT: B= -0.44; 95% CI=-0.65, -0.22; p < 0.001.
NUMSESS
B= -0.64; 95% CI=-0.82, -0.46; p < 0.001).
CONCLUSIONS
BMI-MTM is a feasible misuse intervention associated with superior satisfaction and outcomes than SMC. Future research should test BMI-MTM in a large-scale, fully-powered trial.",2019,"Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001.
NUMSESS
AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = ","['screened patients for prescription opioid misuse at point-of-service using the Prescription Opioid Misuse Index', '2 community pharmacies']","['standard medication counseling (SMC) or SMC\u202f+\u202fBMI-MTM', 'Brief Motivational Intervention-Medication Therapy Management (BMI-MTM) intervention']","['number of sessions completed [NUMSESS', 'pain and depression', 'feasibility, acceptability, and mitigation of opioid medication misuse', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",32.0,0.100783,"Compared to SMC at 3-months, BMI-MTM recipients reported greater improvements in misuse (ITT: Adjusted Odds Ratio [AOR] = 0.13; 95% CI = 0.05, 0.35, p < 0.001.
NUMSESS
AOR = 0.05; 95% CI = 0.01, 0.25; p < 0.001), pain (ITT: В = 8.8, 95% CI=-0.95, 18.5, p = 0.08; NUMSESS: В = ","[{'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Cochran', 'Affiliation': 'University of Utah, School of Medicine, Department of Internal Medicine, 30 N 1900 E, Room 4C104, Salt Lake City, Utah, 84132, USA; University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: jerry.cochran@hsc.utah.edu.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: QIC31@pitt.edu.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Field', 'Affiliation': 'University of Texas, El Paso, Department of Psychology, Psychology Building, Room 112 500 W University, El Paso, Texas, 79902, USA. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Seybert', 'Affiliation': 'University of Pittsburgh, School of Pharmacy, Department of Pharmacy and Therapeutics, 3501 Terrace St, Pittsburgh, PA, 15261, USA. Electronic address: seyberta@pitt.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Hruschak', 'Affiliation': 'University of Pittsburgh, School of Social Work 2117 Cathedral of Learning, 4200 Fifth Avenue, Pittsburgh, PA, 15260, USA. Electronic address: VJH6@pitt.edu.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Jaber', 'Affiliation': 'Falk Pharmacy, UPMC 3601 Fifth Ave, Pittsburgh, PA 15213, USA. Electronic address: jabera@upmc.edu.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Gordon', 'Affiliation': 'University of Utah, School of Medicine, Department of Internal Medicine, 30 N 1900 E, Room 4C104, Salt Lake City, Utah, 84132, USA. Electronic address: Adam.Gordon@hsc.utah.edu.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Tarter', 'Affiliation': 'University of Pittsburgh, School of Pharmacy, Department of Pharmaceutical Sciences, 3501 Terrace St, Pittsburgh, PA, 15261, USA. Electronic address: tarter@pitt.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107570']
478,31704382,Trajectory classes of opioid use among individuals in a randomized controlled trial comparing extended-release naltrexone and buprenorphine-naloxone.,"OBJECTIVES
To advance our understanding of medication treatments for opioid use disorders (OUDs), identification of distinct subgroups and factors associated with differential treatment response is critical. We examined trajectories of opioid use for patients with OUD who were randomized to (but not in all cases inducted onto) buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX), and identified characteristics associated with each trajectory.
METHODS
Growth mixture models (GMMs) were run to identify distinct trajectories of days of opioid use among a subsample of 535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of BUP-NX (n = 281) or XR-NTX (n = 254).
RESULTS
Four distinct opioid use trajectory classes were identified for BUP-NX (near abstinent/no use (59%); low use (13.2%); low use, increasing over time (15%); and moderate use, increasing over time (12.8%)). Three distinct opioid use trajectory classes were found for XR-NTX (near abstinent/no use (59.1%); low use (14.6%); and moderate use, increasing over time (26.4%)). Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits. Within BUP-NX, the low use class had a greater proportion of individuals with a previous successful treatment history compared with other classes. Within XR-NTX, the moderate use, increasing over time class had the highest proportion of Hispanic participants compared with other classes.
CONCLUSIONS
Findings highlight the significant heterogeneity of opioid use during a RCT of BUP-NX and XR-NTX and factors associated with opioid use patterns including medical management visits and history of treatment success.",2019,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","['535 individuals with OUD who participated in a 24-week randomized controlled trial (RCT; 2014-2016) of', 'patients with OUD']","['BUP-NX', 'XR-NTX', 'buprenorphine-naloxone (BUP-NX) or extended-release naltrexone (XR-NTX', 'naltrexone and buprenorphine-naloxone']","['BUP-NX', 'XR-NTX']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine / Naloxone'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]",[],535.0,0.0141898,"Across both BUP-NX and XR-NTX, the near abstinent/no use class had the highest number of medical management visits.","[{'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'Center of Alcohol and Substance Use Studies, Graduate School of Applied and Professional Psychology, Rutgers University, New Brunswick, United States. Electronic address: lesia.ruglass@rutgers.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'New York State Psychiatric Institute, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Biostatistics Department, Mailman School of Public Health, Columbia University, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Department of Psychiatry, Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}, {'ForeName': 'Skye', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, York University, Canada.'}, {'ForeName': 'Celestina', 'Initials': 'C', 'LastName': 'Barbosa-Leiker', 'Affiliation': 'College of Nursing, Washington State University, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, United States.'}, {'ForeName': 'Shelly F', 'Initials': 'SF', 'LastName': 'Greenfield', 'Affiliation': 'Harvard Medical School and McLean Hospital, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University School of Medicine, United States.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center and New York State Psychiatric Institute, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107649']
479,32153209,Using predictive analytics to improve pragmatic trial design.,"Clinical trials embedded in health systems can randomize large populations using automated data sources to determine trial eligibility and assess outcomes. The suicide prevention outreach trial used real-world data for trial design and randomized 18,868 individuals in four health systems using patient-reported thoughts of death or self-harm (Patient Health Questionnaire item 9). This took 3.5 years. We consider if using predictive analytics, that is, suicide risk estimates based on prediction models, could improve trial ""efficiency."" We used data on mental health outpatient visits between 1 January 2009 and 30 September 2017 in seven health systems (HealthPartners; Henry Ford Health System; and Colorado, Hawaii, Northwest, Southern California, and Washington Kaiser Permanente regions). We used a suicide risk prediction model developed in these same systems. We compared five trial designs with different eligibility criteria: a response of a 2 or 3 on Patient Health Questionnaire item 9, a response of a 3, suicide risk score above 90th, 95th, or 99th percentile. We compared the sample that met each criterion, 90-day suicide attempt rate following first eligible visit, and necessary sample sizes to detect a 15%, 25%, and 35% relative reduction in the suicide attempt rate, assuming 90% power, for each eligibility criterion. Our sample included 24,355,599 outpatient visits. Despite wide-spread use of Patient Health Questionnaire, 21,026,985 (86.3%) visits did not have a recorded Patient Health Questionnaire. Of the 2,928,927 individuals in our sample, 109,861 had a recorded Patient Health Questionnaire item 9 response of a 2 or 3 over the study years with a 1.40% 90-day suicide attempt rate and 50,047 had a response of a 3 (suicide attempt rate 1.98%). More patients met criteria requiring a certain risk score or higher: 331,273 had a 90th percentile risk score or higher (suicide attempt rate: 1.36%); 182,316 a 95th percentile or higher (suicide attempt rate 2.16%), and 78,655 a 99th percentile or higher (suicide attempt rate: 3.95%). Eligibility criterion of a Patient Health Questionnaire item 9 response of a 2 or 3 would require randomizing 44,081 individuals (40.2% of eligible population in our sample); eligibility criterion of a 3 would require 31,024 individuals (62.0% of eligible population). Eligibility criterion of a suicide risk score of 90th percentile or higher would require 45,675 individuals (13.8% of eligible population), 95th percentile 28,699 individuals (15.7% of eligible population), and 99th percentile 15,509 (19.7% of eligible population). A suicide risk prediction calculator could improve trial ""efficiency""; identifying more individuals at increased suicide risk than relying on patient-report. It is an open scientific question if individuals identified using predictive analytics would respond differently to interventions than those identified by more traditional means.",2020,"Despite wide-spread use of Patient Health Questionnaire, 21,026,985 (86.3%) visits did not have a recorded Patient Health Questionnaire.","['2,928,927 individuals in our sample, 109,861 had a recorded Patient Health Questionnaire item 9 response of a 2 or 3 over the study years with a 1.40% 90-day suicide attempt rate and 50,047 had a response of a 3 (suicide attempt rate 1.98', '18,868 individuals in four health systems using patient-reported thoughts of death or self-harm (Patient Health Questionnaire item 9', 'mental health outpatient visits between 1 January 2009 and 30 September 2017 in seven health systems (HealthPartners; Henry Ford Health System; and Colorado, Hawaii, Northwest, Southern California, and Washington Kaiser Permanente regions', 'Eligibility criterion of a suicide risk score of 90th percentile or higher would require 45,675 individuals (13.8% of eligible population), 95th percentile 28,699 individuals (15.7% of eligible population), and 99th percentile 15,509 (19.7% of eligible population', 'More patients met criteria requiring a certain risk score or higher: 331,273 had a 90th percentile risk score or higher (suicide attempt rate: 1.36%); 182,316 a 95th percentile or higher (suicide attempt rate 2.16%), and 78,655 a 99th percentile or higher (suicide attempt rate: 3.95', 'Eligibility criterion of a Patient Health Questionnaire item 9 response of a 2 or 3 would require randomizing 44,081 individuals (40.2% of eligible population in our sample); eligibility criterion of a 3 would require 31,024 individuals (62.0% of eligible population']",[],['90-day suicide attempt rate'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0582517', 'cui_str': 'henry (qualifier value)'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0018619', 'cui_str': 'Hawaii'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4708912', 'cui_str': '1.36 (qualifier value)'}, {'cui': 'C4517627', 'cui_str': '2.16 (qualifier value)'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}]",18868.0,0.0822878,"Despite wide-spread use of Patient Health Questionnaire, 21,026,985 (86.3%) visits did not have a recorded Patient Health Questionnaire.","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Shortreed', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Gregory E', 'Initials': 'GE', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520910367']
480,32069067,"Efficacy of Insulclock in Patients with Poorly Controlled Type 1 Diabetes Mellitus: A Pilot, Randomized Clinical Trial.","Insulclock ® is an electronic device designed to improve treatment adherence and insulin injection tracking. This randomized, single-center, pilot study assessed the clinical impact of Insulclock on glycemic control and variability, treatment adherence, and satisfaction in patients with uncontrolled type 1 diabetes mellitus (T1DM). We also compared these outcomes between the Active and Masked groups (with or without receiving reminders and app alerts). Sixteen patients completed the study: 10 in the Active group and 6 in the Masked group. Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL [1.5 mmol/L]; P = 0.013), glucose standard deviation (-14.4 mg/dL [0.8 mmol/L]; P = 0.003), and time above range (-12.5%; P = 0.0026), and an increase in time in range (TIR) (+7%; P = 0.038) in the overall population. The use of app information and alerts in the Active group was associated with an increase in TIR (+8%; P = 0.026). We observed a -3.9 ( P = 0.1352) and -5.4 ( P = 0.032) reduction per month in the number of missed and mistimed insulin doses in the overall population, respectively. Most of the items of the Insulin Treatment Satisfaction Questionnaire (ITSQ) improved after 4 weeks of Insulclock use. This pilot study points out an improvement in glycemic levels, adherence, and satisfaction in T1DM patients, supporting the development of clinical trials powered to confirm these effects.",2020,Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL,"['patients with uncontrolled Type 1 diabetes mellitus (T1DM', 'patients with poorly controlled type 1 diabetes mellitus', 'Sixteen patients completed the study: ten in the Active group and six in the Masked group']",['Insulclock'],"['time above range (TAR', 'glucose standard deviation (SD', 'mean glucose', 'TIR', 'time in range (TIR', 'Insulin Treatment Satisfaction Questionnaire (ITSQ', 'glycemic levels, adherence and satisfaction', 'glycemic control and variability, treatment adherence and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3887664', 'cui_str': 'Tars, topical antipsoriatics'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]",16.0,0.0771619,Insulclock use was associated with a decrease in mean glucose (-27.0 mg/dL,"[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Gomez-Peralta', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Abreu', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Gomez-Rodriguez', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Cruz-Bravo', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'María-Sanchez', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Poza', 'Affiliation': 'Endocrinology and Nutrition Unit, Segovia General Hospital, Segovia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ruiz-Valdepeñas', 'Affiliation': 'Research and Development Unit, Insulcloud S.L. (B87131454), Madrid, Spain.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0427']
481,31888938,Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D Feasibility): a randomised feasibility trial protocol.,"INTRODUCTION
Type 2 diabetes is common, affecting over 400 million people worldwide. Risk of serious complications can be reduced through use of effective treatments and active self-management. However, people are often concerned about starting new medicines and face difficulties in taking them regularly. Use of brief messages to provide education and support self-management, delivered through mobile phone-based text messages, can be an effective tool for some long-term conditions. We have developed messages aiming to support patients' self-management of type 2 diabetes in the use of medications and other aspects of self-management, underpinned by theory and evidence. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the intervention, compared with usual care.
METHODS AND ANALYSIS
The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England. Consenting participants will be randomised to receive short text messages three times a week with messages designed to produce change in medication adherence or non-health-related messages for 6 months. The aims are to test recruitment methods, retention to the study, the feasibility of data collection and the mobile phone and web-based processes of a proposed definitive trial and to refine the text messaging intervention. The primary outcome is the rate of recruitment to randomisation of participants to the trial. Data, including patient reported measures, will be collected online at baseline and the end of the 6-month follow-up period. With 200 participants (100 in each group), this trial is powered to estimate 80% follow-up within 95% CIs of 73.8% to 85.3%. The analysis will follow a prespecified plan.
ETHICS AND DISSEMINATION
Ethics approval was obtained from the West of Scotland Research Ethics Committee 05. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: www.summit-d.org (SuMMiT-D (SUpport through Mobile Messaging and digital health Technology for Diabetes)).
TRIAL REGISTRATION NUMBER
ISRCTN13404264.",2019,"The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England.","['primary care recruiting adults (≥35 years) with type 2 diabetes in England', 'Consenting participants']",['short text messages three times a week with messages designed to produce change in medication adherence or non-health-related messages for 6\u2009months'],"['rate of recruitment to randomisation', 'effectiveness and cost-effectiveness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",200.0,0.243696,"The feasibility trial will be a multicentre individually randomised, controlled trial in primary care recruiting adults (≥35 years) with type 2 diabetes in England.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Farmer', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK andrew.farmer@phc.ox.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'Bartlett', 'Affiliation': 'The Division of Psychology and Mental Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'Division of Population Health, Health Services Research & Primary Care, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'The Institute of Biomedical Engineering, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'French', 'Affiliation': 'The Division of Psychology and Mental Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gudgin', 'Affiliation': 'Patient Representative, Oxford, UK.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Holmes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Horne', 'Affiliation': 'UCL School of Pharmacy, University College London, London, UK.'}, {'ForeName': 'Dyfrig A', 'Initials': 'DA', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Kenning', 'Affiliation': 'Institute of Population Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Locock', 'Affiliation': 'Health Service Research, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'McSharry', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Miles', 'Affiliation': 'Division of Psychology and Mental Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Newhouse', 'Affiliation': ''}, {'ForeName': 'Rustam', 'Initials': 'R', 'LastName': 'Rea', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Riga', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Tarassenko', 'Affiliation': 'The Institute of Biomedical Engineering, University of Oxford, Oxford, UK.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Velardo', 'Affiliation': 'The Institute of Biomedical Engineering, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Williams', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033504']
482,30370983,Lack of Target Engagement Following Low-Frequency Deep Transcranial Magnetic Stimulation of the Anterior Insula.,"OBJECTIVE
To evaluate the safety and efficacy of low-frequency, inhibitory, deep rTMS with a novel H-coil specifically designed to stimulate the insula.
METHODS
In a randomized, crossover order, 16 healthy volunteers underwent two sessions (sham; active) of 1 Hz repetitive TMS at an intensity of 120% of individual motor threshold, over the right anterior insular cortex localized using a neuronavigation system. Before, immediately after, and one hour after rTMS, subjects performed two tasks that have previously been shown in fMRI experiments to activate insular cortex: A blink suppression task and a forced-choice risk-taking task.
RESULTS
No drop-outs or adverse events occurred. Active deep rTMS did not result in decreased urge to blink compared to sham. Similarly, no significant time × condition interaction on risk-taking behavior was found.
CONCLUSIONS
Low-frequency deep rTMS using a novel H8 coil was shown to be safe but did not affect any of the behavioral markers, also used to investigate modulation of insula activity. Our findings highlight the challenges of modulating the activity of deep brain regions with TMS. Further studies are necessary to identify effective stimulation parameters for deep targets, and to characterize the effects of deep TMS on overlying cortical regions.",2019,"deep rTMS using a novel H8 coil was shown to be safe but did not affect any of the behavioral markers, also used to investigate modulation of insula activity.",['16 healthy volunteers underwent'],['two sessions (sham; active) of 1 Hz repetitive TMS'],"['risk-taking behavior', 'safety and efficacy', 'urge to blink', 'drop-outs or adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",16.0,0.0168752,"deep rTMS using a novel H8 coil was shown to be safe but did not affect any of the behavioral markers, also used to investigate modulation of insula activity.","[{'ForeName': 'Primavera A', 'Initials': 'PA', 'LastName': 'Spagnolo', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Prachaya', 'Initials': 'P', 'LastName': 'Srivanitchapoom', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Center for Social and Affective Neuroscience, IKE, Linkoping University, Linkoping, Sweden.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.12875']
483,32151645,Clinical and virological responses to a broad-spectrum human monoclonal antibody in an influenza virus challenge study.,"Influenza A infections cause significant seasonal morbidity and mortality as well as periodic pandemic infections. Currently, no approved therapies exist for patients hospitalized with influenza. The efficacy of VIS410, a broadly neutralizing human immunoglobulin IgG1 monoclonal antibody engineered to bind to the stem region of group 1 and 2 influenza A hemagglutinins, was explored in experimental human influenza infection. Healthy volunteers were inoculated with influenza A/California/07/2009 (H1N1) and received a single dose of VIS410 or placebo 24 h later. Subjects were monitored for symptoms, viral shedding, and safety, including cytokine measurements. The primary efficacy endpoint was the area under the curve (AUC) of viral load (VL) in the VIS410 group versus placebo. VIS410 treatment was associated with a 76% reduction in median VL AUC as measured by qRT-PCR (p = 0.024). Similar VIS410 antiviral activity was observed by virus culture, with a 91% reduction in median VL AUC by TCID 50 (p = 0.019) compared to placebo-treated volunteers. Influenza symptoms were generally mild or moderate, with a trend toward faster resolution in VIS410-treated subjects. Treatment with VIS410 was generally safe, with an increase in gastrointestinal events that were largely mitigated by pre-treatment with oral diphenhydramine (50 mg) in combination with 600 mg of ibuprofen. Transient elevation of specific cytokines (IL-8 and TNFα) were associated with gastrointestinal adverse events. Treatment with VIS410 did not interfere with the endogenous immune response to influenza A. These data indicate that VIS410 may provide therapeutic benefit in influenza A infection. TRIAL REGISTRATION: ClinicaTtrials.gov Identification NCT02468115; https://clinicaltrials.gov/ct2/show/NCT02468115?term=NCT02468115&rank=1).",2020,VIS410 treatment was associated with a 76% reduction in median VL AUC as measured by qRT-PCR (p = 0.024).,"['patients hospitalized with influenza', 'Healthy volunteers']","['VIS410', 'ibuprofen', 'placebo', 'influenza A/California/07/2009 (H1N1) and received a single dose of VIS410 or placebo', 'oral diphenhydramine']","['area under the curve (AUC) of viral load (VL', 'Transient elevation of specific cytokines (IL-8 and TNFα', 'Influenza symptoms', 'gastrointestinal events', 'Similar VIS410 antiviral activity', 'symptoms, viral shedding, and safety, including cytokine measurements', 'median VL AUC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2076600', 'cui_str': 'Influenza caused by Influenza A virus subtype H1N1'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.063666,VIS410 treatment was associated with a 76% reduction in median VL AUC as measured by qRT-PCR (p = 0.024).,"[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Sloan', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA.'}, {'ForeName': 'Kristy J', 'Initials': 'KJ', 'LastName': 'Szretter', 'Affiliation': 'Takeda Pharmaceuticals International, Inc., Cambridge, Massachusetts 02139, USA.'}, {'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Sundaresh', 'Affiliation': 'Boston College, Chestnut Hill, MA, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Narayan', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Smith', 'Affiliation': 'Certara, Parsippany, NJ, 07054, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skurnik', 'Affiliation': ""Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Institut Necker-Enfants Malades, INSERM U1151, CNRS UMR, 8253, Paris, France; Université Paris Descartes, Paris, France; Service de Microbiologie, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Bedard', 'Affiliation': 'Clin Ops Solutions, Medford, MA, USA.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Trevejo', 'Affiliation': 'SmartPharm Therapeutics, Inc., Cambridge, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oldach', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Shriver', 'Affiliation': 'Visterra, Inc., Waltham, MA, 02451, USA. Electronic address: zshriver@visterrainc.com.'}]",Antiviral research,['10.1016/j.antiviral.2020.104763']
484,31797880,Randomised trial on clinical performances and biocompatibility of four high-flux hemodialyzers in two mode treatments: hemodialysis vs post dilution hemodiafiltration.,"This prospective multicenter randomized comparative cross-over trial aimed at evaluating the influence of hemodialysis vs post-dilution hemodiafiltration with high-flux dialyzers in solute clearance and biocompatibility profile. 32 patients were sequentially dialyzed with Leoceed-21HX, Polypure-22S+, Rexsys-27H and VIE-21A. Primary outcome was β2-microglobulin removal. Secondary outcomes were (i) extraction of other uremic solutes (ii) parameters of inflammation and nutrition and (iii) comparative quantification of perdialytic albumin losses (using total 'TDC' vs partial 'PDC' collection of dialysate). Significant increases in removal rates of β2-microglobulin (84.7 ± 0.8 vs 71.6 ± 0.8 mg/L), myoglobin (65.9 ± 1.3 vs 38.6 ± 1.3 µg/L), free immunoglobulin light chains Kappa (74.9 ± 0.8 vs 55.6 ± 0.8 mg/L), β-trace protein (54.8 ± 1.3 vs 26.8 ± 1.4 mg/L) and orosomucoid (11.0 ± 1.1 vs 6.0 ± 1.1 g/L) but not myostatin (14.8 ± 1.5 vs 13.0 ± 1.5 ng/mL) were observed in HDF compared to HD when pooling all dialyzers. Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys. Inflammatory parameters were unchanged between dialyzers without any interaction with dialysis modality. Mean dialysate albumin loss was comparable between TDC and PDC (1.855 vs 1.826 g/session for TDC and PDC respectively). In addition, a significant difference in albumin loss was observed between dialyzers with the highest value (4.5 g/session) observed using Rexsys. Use of all dialyzers was associated with good removals of the large spectrum of uremic toxins tested and good biocompatibility profiles, with an additional gain in removal performances with HDF. Larger surface area, thinner wall and resultant very high ultrafiltration coefficient of Rexsys should be taken into account in its clear performance advantages.",2019,"Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys.","['32 patients were sequentially dialyzed with Leoceed-21HX, Polypure-22S+, Rexsys-27H and VIE-21A']",['hemodialysis vs post-dilution hemodiafiltration with high-flux dialyzers'],"['solute clearance and biocompatibility profile', 'β2-microglobulin removal', 'Mean dialysate albumin loss', 'Inflammatory parameters', ""i) extraction of other uremic solutes (ii) parameters of inflammation and nutrition and (iii) comparative quantification of perdialytic albumin losses (using total 'TDC' vs partial 'PDC' collection of dialysate"", 'albumin loss', 'β-trace protein', 'removal rates of β2-microglobulin', 'free immunoglobulin light chains Kappa']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0445431', 'cui_str': 'After the filter (qualifier value)'}, {'cui': 'C0206075', 'cui_str': 'Hemodiafiltration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0442822', 'cui_str': 'Trace (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0806492', 'cui_str': 'Free immunoglobulin light chain (substance)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",32.0,0.0260797,"Rexsys and VIE-A use in both HD and HDF subgroups was associated to a better removal of middle/large-size molecules compared to Leoceed and Polypure, except β2-microglobulin for Rexsys.","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Morena', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Creput', 'Affiliation': 'Service de Néphrologie, AURA, Paris, France.'}, {'ForeName': 'Mouloud', 'Initials': 'M', 'LastName': 'Bouzernidj', 'Affiliation': 'Service de Néphrologie, Clinique Hemera Pays de Caux, Yvetot, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Département de Biochimie et Hormonologie, CHU Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Chalabi', 'Affiliation': 'AIDER, Montpellier, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Seigneuric', 'Affiliation': 'Service de Néphrologie, CHU Toulouse, Toulouse, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lauret', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Bargnoux', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Dupuy', 'Affiliation': 'Département de Biochimie et Hormonologie, CHU Montpellier, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Cristol', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Département de Biochimie et Hormonologie, CHU Montpellier, Montpellier, France. jp-cristol@chu-montpellier.fr.'}]",Scientific reports,['10.1038/s41598-019-54404-7']
485,32147878,Effect of Tooth Preparation Design on Fracture Resistance of Zirconia-Reinforced Lithium Silicate Overlays.,"PURPOSE
To assess the effect of tooth preparation design on fracture resistance of zirconia-reinforced lithium silicate overlays.
MATERIALS AND METHODS
This study evaluated 50 human maxillary first molars with no caries, restorations or anatomical defects. The teeth were randomly divided into five groups (n = 10/group) based on preparation design for the fabrication of overlay restorations: (O) anatomical occlusal reduction, (OS) anatomical occlusal reduction with round shoulder preparation, (OG) anatomical occlusal reduction with a central groove, (OSG) anatomical occlusal reduction with round shoulder preparation and central groove, and (C) no preparation of tooth (control group). All restorations were fabricated using zirconia-reinforced lithium silicate (Vita Suprinity). The specimens underwent thermomechanical fatigue loading in a masticatory simulator (1.2 million cycles at 98 N). Fracture resistance was measured using a universal testing machine. The mode of failure was determined as well. Data were analyzed using one-way ANOVA followed by Tukey's post-hoc test, paired t-test and Fisher's exact test (α = 0.05).
RESULTS
Group O showed significantly higher fracture resistance than groups OG and OSG (p = 0.002 and p = 0.001, respectively). The fracture resistance of group OS was significantly higher than that of group OSG (p = 0.008). The fracture resistance of the control group was significantly higher than that of OG and OSG (p = 0.001) and had no significant difference with other groups.
CONCLUSIONS
Group O (anatomical occlusal reduction alone), which had the most conservative preparation design, yielded the highest fracture resistance.",2020,The fracture resistance of group OS was significantly higher than that of group OSG (P = 0.008).,"['50 human maxillary first molars with no caries, restorations or anatomical defects', 'Fracture Resistance of Zirconia-Reinforced Lithium Silicate Overlays']","['thermomechanical fatigue loading in a masticatory simulator', 'preparation design for the fabrication of overlay restorations: (O) anatomical occlusal reduction, (OS) anatomical occlusal reduction with round shoulder preparation, (OG) anatomical occlusal reduction with a central groove, (OSG) anatomical occlusal reduction with round shoulder preparation and central groove, and (C) no preparation of tooth (control group']","['Fracture resistance', 'fracture resistance of group OS', 'fracture resistance']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0086983', 'cui_str': 'Silicates'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0444456', 'cui_str': 'Overlay (qualifier value)'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",50.0,0.0246171,The fracture resistance of group OS was significantly higher than that of group OSG (P = 0.008).,"[{'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Falahchai', 'Affiliation': 'Dental Sciences Research Center, Department of Prosthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Yasamin', 'Initials': 'Y', 'LastName': 'Babaee Hemmati', 'Affiliation': 'Dental Sciences Research Center, Department of Orthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Neshandar Asli', 'Affiliation': 'Dental Sciences Research Center, Department of Prosthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Rezaei', 'Affiliation': 'Dental Sciences Research Center, Department of Prosthodontics, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.13160']
486,31393176,Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.,"Background: The G lycemia R eduction A pproaches in D iabetes: A Comparative E ffectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. Methods: The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations. Conclusions: The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities.",2019,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. ","['Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other', 'patients of different races or ethnicities', 'enrolled a racially and ethnically diverse population with type 2 diabetes', '1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared']",['CGM'],"['R eduction', 'average glucose (AG) and hemoglobin A1c (HbA1c']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]",[],"[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",450.0,0.0248676,"CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. ","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larkin', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Krause-Steinrauf', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Herman', 'Affiliation': 'Internal Medicine and Epidemiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Higgins', 'Affiliation': 'Department of Systems Biology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Tiktin', 'Affiliation': 'Multidisciplinary Research, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Cincinnati VA Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': 'The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute of Public Health, The George Washington University, Rockville, Maryland.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Health Partners Institute, International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Arends', 'Affiliation': 'Advanced Research and Diagnostic Laboratory, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0202']
487,31318261,"Parenting time, parenting quality, interparental conflict, and mental health problems of children in high-conflict divorce.","Despite widespread acknowledgment that ""frequent, continuing, and meaningful"" (Pruett & DiFonzo, 2014) time with both parents is beneficial for children from divorced or separated families, and that interparental conflict (IPC) is associated with increased child mental health problems, the joint effects of parenting time (PT), parenting quality (PQ), and IPC on children's mental health problems are less clear. The current study integrates two theoretical models in multiple mediator analyses to test indirect effects of mothers' and fathers' PQ and IPC to explain the association between PT and children's mental health problems within the same model. Participants were children aged 9-18 years ( N = 141) who had one or both parents participate in a randomized comparative effectiveness trial of a court-based prevention program for high-conflict divorcing or separating families. Data were collected at pretest and 9-month follow-up. Analyses revealed an indirect effect in which fathers' PQ mediated the association between PT and child internalizing problems both concurrently and 9 months later. There were no significant indirect effects involving IPC. Analyses indicated a significant quadratic relation between PT and fathers' PQ, suggesting that although more PT is associated with better father-child relationships, there is a point beyond which more time is not related to a better relationship. We discuss the study findings, research limitations, and implications for public policy. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,There were no significant indirect effects involving IPC.,['Participants were children aged 9-18 years ( N = 141) who had one or both parents participate'],['court-based prevention program for high-conflict divorcing or separating families'],"['Parenting time, parenting quality, interparental conflict, and mental health problems of children in high-conflict divorce', 'parenting time (PT), parenting quality (PQ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1955961', 'cui_str': 'Interparental Conflict'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}]",2019.0,0.0231281,There were no significant indirect effects involving IPC.,"[{'ForeName': 'Karey L', 'Initials': 'KL', 'LastName': ""O'Hara"", 'Affiliation': 'REACH Institute.'}, {'ForeName': 'Irwin N', 'Initials': 'IN', 'LastName': 'Sandler', 'Affiliation': 'REACH Institute.'}, {'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Wolchik', 'Affiliation': 'REACH Institute.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'REACH Institute.'}, {'ForeName': 'C Aubrey', 'Initials': 'CA', 'LastName': 'Rhodes', 'Affiliation': 'REACH Institute.'}]",Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43),['10.1037/fam0000556']
488,29698924,Integrative metabolomics and transcriptomics signatures of clinical tolerance to Plasmodium vivax reveal activation of innate cell immunity and T cell signaling.,"Almost invariably, humans become ill during primary infections with malaria parasites which is a pathology associated with oxidative stress and perturbations in metabolism. Importantly, repetitive exposure to Plasmodium results in asymptomatic infections, which is a condition defined as clinical tolerance. Integration of transcriptomics and metabolomics data provides a powerful way to investigate complex disease processes involving oxidative stress, energy metabolism and immune cell activation. We used metabolomics and transcriptomics to investigate the different clinical outcomes in a P. vivax controlled human malaria infection trial. At baseline, the naïve and semi-immune subjects differed in the expression of interferon related genes, neutrophil and B cell signatures that progressed with distinct kinetics after infection. Metabolomics data indicated differences in amino acid pathways and lipid metabolism between the two groups. Top pathways during the course of infection included methionine and cysteine metabolism, fatty acid metabolism and urea cycle. There is also evidence for the activation of lipoxygenase, cyclooxygenase and non-specific lipid peroxidation products in the semi-immune group. The integration of transcriptomics and metabolomics revealed concerted molecular events triggered by the infection, notably involving platelet activation, innate immunity and T cell signaling. Additional experiment confirmed that the metabolites associated with platelet activation genes were indeed enriched in the platelet metabolome.",2018,"At baseline, the naïve and semi-immune subjects differed in the expression of interferon related genes, neutrophil and B cell signatures that progressed with distinct kinetics after infection.",[],[],"['methionine and cysteine metabolism, fatty acid metabolism and urea cycle', 'amino acid pathways and lipid metabolism']",[],[],"[{'cui': 'C0025646', 'cui_str': 'L-methionine'}, {'cui': 'C0010654', 'cui_str': 'L-cysteine'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",,0.0468749,"At baseline, the naïve and semi-immune subjects differed in the expression of interferon related genes, neutrophil and B cell signatures that progressed with distinct kinetics after infection.","[{'ForeName': 'Luiz G', 'Initials': 'LG', 'LastName': 'Gardinassi', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Arévalo-Herrera', 'Affiliation': 'Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia; Faculty of Health, Universidad del Valle, Cali, Colombia.'}, {'ForeName': 'Sócrates', 'Initials': 'S', 'LastName': 'Herrera', 'Affiliation': 'Malaria Vaccine and Drug Development Center (MVDC), Cali, Colombia; Caucaseco Scientific Research Center, Cali, Colombia.'}, {'ForeName': 'Regina J', 'Initials': 'RJ', 'LastName': 'Cordy', 'Affiliation': 'International Center for Malaria Research, Education and Development, Emory Vaccine Center, Yerkes National Primate Research Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'ViLinh', 'Initials': 'V', 'LastName': 'Tran', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Smith', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Johnson', 'Affiliation': 'Department of Pathology and Mitochondrial Medicine Laboratory, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Balu', 'Initials': 'B', 'LastName': 'Chacko', 'Affiliation': 'Department of Pathology and Mitochondrial Medicine Laboratory, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Ken H', 'Initials': 'KH', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Darley-Usmar', 'Affiliation': 'Department of Pathology and Mitochondrial Medicine Laboratory, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Young-Mi', 'Initials': 'YM', 'LastName': 'Go', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Dean P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Galinski', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA; International Center for Malaria Research, Education and Development, Emory Vaccine Center, Yerkes National Primate Research Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Shuzhao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, School of Medicine, Emory University, 615 Michael Street, Atlanta, GA 30322-1047, USA. Electronic address: shuzhao.li@gmail.com.'}]",Redox biology,['10.1016/j.redox.2018.04.011']
489,31623857,"Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study.","OBJECTIVE
We sought to determine safety and efficacy of the AKT inhibitor, GSK2141795, combined with the MEK inhibitor, trametinib, in endometrial cancer.
METHODS
Patients with measurable recurrent endometrial cancer were eligible. One to two prior cytotoxic regimens were allowed; prior use of a MEK or PI3K pathway inhibitor was excluded. Initial trial design consisted of a KRAS mutation stratified randomized phase II with a safety lead-in evaluating the combination. For the safety lead in, the previously recommended phase 2 dose (RP2D; trametinib 1.5 mg, GSK2141795 50 mg) was chosen for Dose Level 1 (DL1).
RESULTS
Of 26 enrolled patients, 14 were treated on DL1 and 12 were treated on DL-1 (trametinib 1.5 mg, GSK2141795 25 mg). Most common histologies were endometrioid (58%) and serous (27%). Four of 25 (16%) patients were KRAS mutant. Dose limiting toxicities (DLTs) were assessed during cycle 1. DL1 had 8 DLTs (hypertension (n = 2), mucositis (2), rash (2), dehydration, stroke/acute kidney injury). DL1 was deemed non-tolerable so DL-1 was explored. DL-1 had no DLTs. Sixty-five percent of patients had ≥ grade 3 toxicity. There were no responses in DL1 (0%, 90%CI 0-15%) and 1 response in DL-1 (8.3%, 90%CI 0.4-33.9%). Proportion PFS at 6 months for DL1 is 14%, and 25% for DL-1.
CONCLUSION
The combination of trametinib and GSK2141795 had high levels of toxicity in endometrial cancer at the previously RP2D but was tolerable at a reduced dose. Due to insufficient preliminary efficacy at a tolerable dose, the Phase II study was not initiated.",2019,"There were no responses in DL1 (0%, 90%CI 0-15%) and 1 response in DL-1 (8.3%, 90%CI 0.4-33.9%).","['26 enrolled patients, 14 were treated on DL1 and 12 were treated on DL-1', 'patients with recurrent endometrial cancer', 'Patients with measurable recurrent endometrial cancer were eligible']",[],"['DL1', 'toxicity', 'Dose limiting toxicities (DLTs', 'mucositis (2), rash (2), dehydration, stroke/acute kidney injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}]",[],"[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]",26.0,0.0759544,"There were no responses in DL1 (0%, 90%CI 0-15%) and 1 response in DL-1 (8.3%, 90%CI 0.4-33.9%).","[{'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'Department of Gynecologic Oncology, University of Texas M. D Anderson Cancer Center, USA. Electronic address: swestin@mdanderson.org.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'NRG Oncology Statistics and Data Management Center Buffalo Office, Roswell Park Cancer Institute, USA. Electronic address: SillM@NRGOncology.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology, University of Texas M. D Anderson Cancer Center, USA. Electronic address: rcoleman@mdanderson.org.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Waggoner', 'Affiliation': 'Department of Gynecologic Oncology, Case Western Reserve University, USA. Electronic address: Steven.Waggoner@UHhospitals.org.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Department of Gynecologic Oncology, University of Oklahoma Health Sciences Center, Stephenson Cancer Center, USA. Electronic address: Kathleen-moore@ouhsc.edu.'}, {'ForeName': 'Cara A', 'Initials': 'CA', 'LastName': 'Mathews', 'Affiliation': 'Department of Gynecologic Oncology, Women & Infants Hospital, USA. Electronic address: cmathews@wihri.org.'}, {'ForeName': 'Lainie P', 'Initials': 'LP', 'LastName': 'Martin', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, USA. Electronic address: lainie.martin@uphs.upenn.edu.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Modesitt', 'Affiliation': 'Director of Gynecologic Oncology Division, University of Virginia, USA. Electronic address: scm6h@virginia.edu.'}, {'ForeName': 'Sanghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine and the UVA Cancer Center, University of Virginia, USA. Electronic address: SLee29@mdanderson.org.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Ju', 'Affiliation': 'Department of Bioinformatics and Computational Biology, University of Texas M. D Anderson Cancer Center, USA. Electronic address: zju@mdanderson.org.'}, {'ForeName': 'Gordon B', 'Initials': 'GB', 'LastName': 'Mills', 'Affiliation': 'Department of Medicine and the UVA Cancer Center, University of Virginia, USA. Electronic address: millsg@ohsu.edu.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital, USA. Electronic address: russell.schilder@jefferson.edu.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Fracasso', 'Affiliation': 'Department of Systems Biology, University of Texas M.D Anderson Cancer Center, USA. Electronic address: fracasso@virginia.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'OB/GYN and Pathology, University of Alabama at Birmingham, USA. Electronic address: mbirrer@uab.edu.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, USA. Electronic address: aghajanc@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.09.024']
490,30636734,Resting Cerebral Blood Flow After Exercise Training in Mild Cognitive Impairment.,"BACKGROUND
Exercise training has been associated with greater cerebral blood flow (CBF) in cognitively normal older adults (CN). Alterations in CBF, including compensatory perfusion in the prefrontal cortex, may facilitate changes to the brain's neural infrastructure.
OBJECTIVE
To examine the effects of a 12-week aerobic exercise intervention on resting CBF and cognition in CN and those with mild cognitive impairment (MCI). We hypothesized individuals with MCI (versus CN) would exhibit greater whole brain CBF at baseline and that exercise would mitigate these differences. We also expected CBF changes to parallel cognitive improvements.
METHODS
Before and after a 12-week exercise intervention, 18 CN and 17 MCI participants (aged 61-88) underwent aerobic fitness testing, neuropsychological assessment, and an MRI scan. Perfusion-weighted images were collected using a GE 3T MR system. Repeated measures analyses of covariance were used to test within- and between-group differences over time, followed by post-hoc analyses to examine links between CBF changes and cognitive improvement.
RESULTS
At baseline, individuals with MCI (versus CN) exhibited significantly elevated perfusion in the left insula. Twelve weeks of aerobic exercise reversed this discrepancy. Additionally, exercise improved working memory (measured by the Rey Auditory Verbal Learning Test) and verbal fluency (measured by the Controlled Oral Word Association Test) and differentially altered CBF depending on cognitive status. Among those with MCI, decreased CBF in the left insula and anterior cingulate cortex was associated with improved verbal fluency.
CONCLUSIONS
Exercise training alters CBF and improves cognitive performance in older adults with and without cognitive impairment. Future studies must evaluate the mediating effects of CBF on the association between exercise training and cognition.",2019,"Among those with MCI, decreased CBF in the left insula and anterior cingulate cortex was associated with improved verbal fluency.
","['older adults with and without cognitive impairment', 'cognitively normal older adults (CN', 'CN and those with mild cognitive impairment (MCI', ' 18 CN and 17 MCI participants (aged 61-88) underwent']","['Exercise Training', 'exercise intervention', 'Exercise training', 'aerobic fitness testing, neuropsychological assessment, and an MRI scan', 'aerobic exercise intervention', 'aerobic exercise', 'Exercise training alters CBF', 'MCI (versus CN']","['verbal fluency', 'Mild Cognitive Impairment', 'Resting Cerebral Blood Flow', 'Rey Auditory Verbal Learning Test) and verbal fluency', 'cerebral blood flow (CBF', 'working memory', 'CBF changes and cognitive improvement', 'CBF', 'cognitive performance']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279962', 'cui_str': 'Fitness Testing'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0917711', 'cui_str': 'MRI Scans'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0162181,"Among those with MCI, decreased CBF in the left insula and anterior cingulate cortex was associated with improved verbal fluency.
","[{'ForeName': 'Alfonso J', 'Initials': 'AJ', 'LastName': 'Alfini', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Weiss', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Kristy A', 'Initials': 'KA', 'LastName': 'Nielson', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Verber', 'Affiliation': 'Department of Chemistry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'J Carson', 'Initials': 'JC', 'LastName': 'Smith', 'Affiliation': 'Department of Kinesiology, University of Maryland, College Park, MD, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-180728']
491,30376772,Multivariate semi-continuous proportionally constrained two-part fixed effects models and applications.,"Semi-continuous data, also known as zero-inflated continuous data, have a substantial portion of responses equal to a single value (typically 0) and a continuous, right-skewed distribution among the remaining positive values. For jointly modeling multivariate clustered semi-continuous responses, the covariate effects in the positive parts can be proportionally constrained to the covariate effects in the logistic part, yielding a multivariate two-part fixed effects model. It is shown that, both theoretically and experimentally, the proportionally constrained model is more efficient than the unconstrained model in terms of parameter estimation, and thus provides a deeper understanding of the data structure when the proportionality structure holds. A robust variance estimation method is also introduced and tested under various model mis-specified cases. The proposed model is applied to data from a randomized controlled trial evaluating potential preventive effects of meditation or exercise on duration and severity of acute respiratory infection illness. The new analysis infers that meditation not only has highly significant effects on reduction of acute respiratory infection severity and duration, but also has significant effects on preventing acute respiratory infection, which was not previously reported in the literature.",2019,"The new analysis infers that meditation not only has highly significant effects on reduction of acute respiratory infection severity and duration, but also has significant effects on preventing acute respiratory infection, which was not previously reported in the literature.",[],['meditation or exercise'],['duration and severity of acute respiratory infection illness'],[],"[{'cui': 'C0150277'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}]",,0.0214774,"The new analysis infers that meditation not only has highly significant effects on reduction of acute respiratory infection severity and duration, but also has significant effects on preventing acute respiratory infection, which was not previously reported in the literature.","[{'ForeName': 'Yaoguo', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Statistics, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Zhengjun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, University of Wisconsin-Madison, Madison, WI, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Rathouz', 'Affiliation': 'Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Barrett', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, Madison, WI, USA.'}]",Statistical methods in medical research,['10.1177/0962280218807730']
492,29753161,"Engagement with INSPIRE, an Online Program for Hematopoietic Cell Transplantation Survivors.","In a secondary analysis of a randomized controlled trial (RCT), we examined participants' engagement with INSPIRE, a personalized online program for hematopoietic cell transplantation (HCT) survivors that focuses on cancer-related distress, depression, fatigue, and health care needs. We approached all adult, 3- to 18-year HCT survivors treated for hematologic malignancy without relapse or second cancer in the previous 2 years for participation in an RCT with either immediate or delayed access to INSPIRE. Participants with immediate access could view the online material at any time. Data included page view tracking, medical records, and patient-reported outcomes, including the Short Form 36 and Cancer and Treatment Distress (CTXD) measures. Of 1322 eligible HCT survivors, 771 (58%) completed the baseline assessment, and 451 received immediate INSPIRE access and were included in analyses. The cohort was 56% male, with a mean age of 52 ± 12.2 years, and 26% received an autologous transplant. Most (77%) logged into the INSPIRE site at least once, and 48% viewed ≥8 pages. Survivors who viewed ≥2 pages were more likely to be age ≥40 years (relative risk [RR], 1.41; 95% confidence interval [CI], 1.10 to 1.80), to be female (RR, 1.22; 95% CI, 1.07 to 1.40), to have chronic graft-versus-host disease (RR, 1.28; 95% CI, 1.08 to 1.51), to be less than 10 years post-HCT (RR, 1.19; 95% CI, 1.01 to 1.39), and to have moderate CTXD distress (RR, 1.34; 95% CI, 1.14 to 1.57). Engagement did not differ by race, education, income, rural/urban residence, computer experience, donor type, or depression (all P ≥ .50). The INSPIRE online program was widely used, including by those who often have reduced access to care after treatment.",2018,"Survivors who viewed ≥2 pages were more likely to be age ≥40 years (relative risk [RR], 1.41; 95% confidence interval [CI], 1.10 to 1.80), to be female (RR, 1.22; 95% CI, 1.07 to 1.40), to have chronic graft-versus-host disease (RR, 1.28; 95% CI, 1.08 to 1.51), to be less than 10 years post-HCT (RR, 1.19; 95% CI, 1.01 to 1.39), and to have moderate CTXD distress (RR, 1.34; 95% CI, 1.14 to 1.57).","['1322 eligible HCT survivors, 771 (58%) completed the baseline assessment, and 451 received immediate INSPIRE access and were included in analyses', 'Hematopoietic Cell Transplantation Survivors', '18-year HCT survivors treated for hematologic malignancy without relapse or second cancer in the previous 2 years for participation in an RCT with either immediate or delayed access to INSPIRE', 'The cohort was 56% male, with a mean age of 52 ± 12.2 years, and 26% received an autologous transplant']",['personalized online program for hematopoietic cell transplantation (HCT) survivors'],"['race, education, income, rural/urban residence, computer experience, donor type, or depression', 'moderate CTXD distress', 'Short Form 36 and Cancer and Treatment Distress (CTXD) measures', 'chronic graft-versus-host disease']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376545', 'cui_str': 'Hematological Neoplasms'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0751623', 'cui_str': 'Second Cancer'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0559189', 'cui_str': 'Autotransplants'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}]",1322.0,0.18521,"Survivors who viewed ≥2 pages were more likely to be age ≥40 years (relative risk [RR], 1.41; 95% confidence interval [CI], 1.10 to 1.80), to be female (RR, 1.22; 95% CI, 1.07 to 1.40), to have chronic graft-versus-host disease (RR, 1.28; 95% CI, 1.08 to 1.51), to be less than 10 years post-HCT (RR, 1.19; 95% CI, 1.01 to 1.39), and to have moderate CTXD distress (RR, 1.34; 95% CI, 1.14 to 1.57).","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Biobehavioral Sciences Department, University of Washington School of Medicine, Seattle, Washington. Electronic address: ksyrjala@fredhutch.org.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Crouch', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Leisenring', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Mary E D', 'Initials': 'MED', 'LastName': 'Flowers', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Biobehavioral Sciences Department, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'Artherholt', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Biobehavioral Sciences Department, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Allison Stover', 'Initials': 'AS', 'LastName': 'Fiscalini', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Romano', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Romano', 'Affiliation': 'Biobehavioral Sciences Department, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Biobehavioral Sciences Department, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Yi', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2018.05.004']
493,32406569,Loop Drainage Is Noninferior to Traditional Incision and Drainage of Cutaneous Abscesses in the Emergency Department.,"BACKGROUND
There is limited research on loop drainage (LD) compared to incision and drainage (I&D) for treatment of cutaneous abscesses. We investigated whether LD was noninferior to I&D for abscess resolution and whether there was any difference in repeat ED visits or complication rates between these techniques.
METHODS
We performed a prospective randomized controlled trial, using a convenience sample at an urban academic emergency department (ED). Subjects over 18 years who presented for first-time management of an abscess were eligible. Patients requiring specialist drainage or hospital admission or had previous treatment for the abscess were excluded. Enrolled subjects were seen 2 weeks after treatment for blinded reevaluation of abscess resolution, and the electronic medical record was reviewed for return ED visits/abscess complications.
RESULTS
Of 2,889 patients screened, 238 subjects consented and were randomized to LD or I&D. Abscess resolution was achieved in 53/65 (81.5%) of patients in the I&D arm, compared to 66/75 (88%) in the LD arm. Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%, p = 0.002). Among returning subjects, there was a significant difference in mean visits per subject between LD and I&D groups (0.5 vs. 1.2, p = 0.001). There were fewer complications among LD than I&D subjects (9.3% vs. 24.6%, p = 0.01).
CONCLUSION
Our study provides evidence that LD is noninferior to I&D in achieving complete abscess resolution at 14 days and is associated with fewer return ED visits and fewer complications. This makes it an attractive alternative treatment option for abscesses.",2020,"Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%,","['convenience sample at an urban academic emergency department (ED', 'Patients requiring specialist drainage or hospital admission or had previous treatment for the abscess were excluded', 'Subjects over 18\xa0years who presented for first-time management of an abscess were eligible', '238 subjects consented', '2,889 patients screened']","['incision and drainage (I&D', 'LD']","['repeat ED visits or complication rates', 'mean visits']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0152277', 'cui_str': 'Incision AND drainage'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0205546', 'cui_str': 'Repeat emergency'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",238.0,0.11263,"Fewer patients in the LD group compared to the I&D group returned to the ED for abscess-related management during the following 14 days (37.3% vs 67.1%,","[{'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Schechter-Perkins', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kristin H', 'Initials': 'KH', 'LastName': 'Dwyer', 'Affiliation': 'the, Department of Emergency Medicine, Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Anish', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'the, Department of Emergency Medicine, Kaiser Permanante Medical Center, Oakland, CA, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Tyler', 'Affiliation': 'the, Department of Emergency Medicine, Advocate Christ Medical Center, Oak Lawn, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Kerrie P', 'Initials': 'KP', 'LastName': 'Nelson', 'Affiliation': 'and the, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Mitchell', 'Affiliation': 'From the, Department of Emergency Medicine, Boston University School of Medicine, Boston, MA, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13981']
494,31653510,"A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study.","OBJECTIVE
Early-phase data have demonstrated induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821. We sought to determine if this combination decreases the hazard of progression or death compared to OPT-821 alone in patients with ovarian cancer in second/third clinical complete remission following chemotherapy. Secondary and translational objectives were overall survival (OS), safety, and immunogenicity.
METHODS
From 2010-2013, patients were randomized (1:1) to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11). Dose delay or reduction was not permitted. Patients were removed for pre-defined dose-limiting toxicity.
RESULTS
Of 171 patients randomized, 170 were treated. Most had disease of serous histology (85%), stage 3 disease at diagnosis (77%), and had received 2 prior regimens (68%). 32% received >6 treatment cycles [median 6, each arm (p = 0.33)]. 77% discontinued due to progression, 4% due to toxicity, and 1 due to myeloid dysplastic syndrome (MDS). Maximum toxicities included grade 4 MDS and depression/personality change (1 each, unlikely related), as well as grade 3 gastrointestinal disorders and others (n = 21, 4 related). Lesser adverse events were injection site reactions (82%) and fever (11%). Estimated HR for progression-free survival (PFS) of the vaccine + OPT-821 to OPT-821 arm was 0.98 (95% CI: 0.71-1.36). At a median follow-up of 60 months, median OS was 47 and 46 months, respectively.
CONCLUSIONS
Vaccine + OPT-821 compared to OPT-821 alone was modestly immunogenic and did not prolong PFS or OS. Multi-remission patients are a viable, well-defined population for exploring innovative consolidation and maintenance approaches.
TRIAL REGISTRATION
NCT00857545.",2019,"32% received >6 treatment cycles [median 6, each arm (p = 0.33)].","['171 patients randomized, 170 were treated', 'patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study', 'patients with ovarian cancer in second/third clinical complete remission following chemotherapy', 'From 2010-2013']","['OPT-821 alone', 'OPT-821±vaccine-KLH conjugate', 'polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821', 'polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384)\xa0+ OPT-821 versus OPT-821']","['overall survival (OS), safety, and immunogenicity', 'hazard of progression or death', 'disease of serous histology', 'median OS', 'PFS or OS', 'Estimated HR for progression-free survival (PFS', 'fever', 'Maximum toxicities included grade 4 MDS and depression/personality change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0064332', 'cui_str': 'KLH antigen'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1175421', 'cui_str': 'Globo-H'}, {'cui': 'C0119960', 'cui_str': 'GM2(NeuGc)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0240735', 'cui_str': 'Personality change (finding)'}]",170.0,0.384314,"32% received >6 treatment cycles [median 6, each arm (p = 0.33)].","[{'ForeName': 'Roisin E', 'Initials': 'RE', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: ocearbhr@mskcc.org.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'NRG Oncology Statistics & Data Management Center, Roswell Park Cancer Institute, Buffalo, NY, USA. Electronic address: wdeng@gogstats.org.'}, {'ForeName': 'Lee-May', 'Initials': 'LM', 'LastName': 'Chen', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA. Electronic address: lee-may.chen@ucsfmedctr.org.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Lucci', 'Affiliation': 'The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Joseph.A.Lucci@uth.tmc.edu.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Behbakht', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA. Electronic address: kian.behbakht@ucdenver.edu.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: nspirtos@wccenter.com.""}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Muller', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM, USA. Electronic address: cmuller@salud.unm.edu.'}, {'ForeName': 'Benedict B', 'Initials': 'BB', 'LastName': 'Benigno', 'Affiliation': 'University Gynecologic Oncology, Atlanta, GA, USA. Electronic address: benedict.benigno@ugynonc.com.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA. Electronic address: powellm@wudosis.wustl.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Berry', 'Affiliation': ""Northwestern Medicine Prentice Women's Hospital, Chicago, IL, USA. Electronic address: https://dremilyberry.com.""}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California Irvine Medical Center, Orange, CA, USA. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Hanjani', 'Affiliation': 'Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, Abington, PA, USA. Electronic address: phanjani@aol.com.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': 'NRG Oncology, Operations Center-Philadelphia East, Philadelphia PA and Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, USA. Electronic address: LankesH@NRGOncology.org.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: aghajanc@mskcc.org.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Sabbatini', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: sabbatip@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.09.015']
495,30871628,Follicular lymphoma patients with KIR2DL2 and KIR3DL1 and their ligands (HLA-C1 and HLA-Bw4) show improved outcome when receiving rituximab.,"BACKGROUND
The ECOG-ACRIN Cancer Research Group evaluated rituximab treatment schedules for patients with newly-diagnosed low-tumor-burden follicular-lymphoma (FL). All patients received 4-weekly rituximab treatments as induction therapy. Clinically-responding patients were randomized to receive rituximab every 13 weeks (""maintenance"") vs. no additional rituximab until progression (""non-maintenance""). Based on ""time-to-rituximab-failure (TTRF)"", the study-committee reported there was no overall-benefit for maintenance rituximab in this setting. Tumor-reactive mAbs, like rituximab, trigger natural killer (NK) cells. NK-cell responses are regulated, in part, by interactions between killer immunoglobulin-like receptors (KIRs) on NK cells and their interactions with KIR-ligands. In a separate study of children with neuroblastoma treated with a different mAb, we found certain KIR/KIR-ligand genotypes associated with improved outcome. Here, we assessed whether a subset of FL patients show improved outcome from the maintenance rituximab based on these same KIR/KIR-ligand genotypes.
METHODS
Genotypes for KIR/KIR-ligand were determined and assessed for associations with outcome [duration of response, TTRF and % tumor shrinkage] as a post-hoc analysis of this phase III trial. Our primary objective was to assess specific KIR/KIR-ligand genotype associations, followed by separate prespecified KIR/KIR-ligand genotype associations in follow-up analyses. Statistical analyses for association of genotype with clinical outcome included: Log-rank tests and Cox proportional hazards regression models to assess duration of response and TTRF; analysis of variance (ANOVA) was used for assessment of % tumor shrinkage.
RESULTS
We found that patients inheriting KIR2DL2 and its ligand (HLA-C1) along with KIR3DL1 and its ligand (HLA-Bw4) had improved outcome over patients without this genotype. In addition, patients with KIR2DL2 and HLA-C1 along with KIR3DL1 and HLA-Bw4 also showed improved duration of response and tumor shrinkage if they received maintenance, while patients without this genotype showed no such improvement when receiving maintenance.
CONCLUSIONS
The data presented here indicate that a subset of FL patients, identified by certain KIRs/KIR-ligands, have improved outcome and may benefit from additional rituximab treatment. Taken together, this suggests that the efficacy of tumor-reactive mAb treatment for some patients is influenced by KIRs on NK cells. However, prior to considering these genotypes in a clinically-actionable manner, these findings need independent validation in other studies.",2019,We found that patients inheriting KIR2DL2 and its ligand (HLA-C1) along with KIR3DL1 and its ligand (HLA-Bw4) had improved outcome over patients without this genotype.,['patients with newly-diagnosed low-tumor-burden follicular-lymphoma (FL'],"['rituximab every 13\u2009weeks (""maintenance"") vs. no additional rituximab until progression (""non-maintenance', 'rituximab', '4-weekly rituximab']",['duration of response and tumor shrinkage'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage (finding)'}]",,0.0319316,We found that patients inheriting KIR2DL2 and its ligand (HLA-C1) along with KIR3DL1 and its ligand (HLA-Bw4) had improved outcome over patients without this genotype.,"[{'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Erbe', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Lakeesha', 'Initials': 'L', 'LastName': 'Carmichael', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hoefges', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Grzywacz', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Patrick K', 'Initials': 'PK', 'LastName': 'Reville', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Songwon', 'Initials': 'S', 'LastName': 'Seo', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Eneida A', 'Initials': 'EA', 'LastName': 'Mendonca', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Yiqiang', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Vaishalee P', 'Initials': 'VP', 'LastName': 'Kenkre', 'Affiliation': 'Department of Medicine, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Fangxin', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Department of Biostatistics, Harvard University, Dana Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Randy D', 'Initials': 'RD', 'LastName': 'Gascoyne', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Centre for Lymphoid Cancer, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Paietta', 'Affiliation': 'Montefiore Medical Center-North Division, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Horning', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Kahl', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'Department of Human Oncology, University of Wisconsin, Madison, WI, USA. pmsondel@humonc.wisc.edu.'}]",Journal for immunotherapy of cancer,['10.1186/s40425-019-0538-8']
496,30265076,"The effects of interpersonal emotional expression, partner responsiveness, and emotional approach coping on stress responses.","[Correction Notice: An Erratum for this article was reported online in Emotion on Sep 5 2019 (see record 2019-52812-001). In the article, two text call outs for figures are incorrect. At the end of the ""Negative emotional responses"" section under the ""Psychological Stress Responses"" heading, ""(see Figure 7)"" should have been deleted. Under the ""Negative task-related ruminative thoughts"" heading in that same section, ""(see Figure 5)"" in the first paragraph should be ""(see Figure 7).""] Expressing emotions is a common strategy for coping with stress. Yet, little is known about the effects of using this strategy in close relationships, or when and for whom emotional expression is effective. This study examined romantic partner responsiveness and the dispositional tendency to use emotional approach coping (EAC; the processing and expression of emotions) as moderators of the effects of experimentally manipulated emotional expression on stress responses to a laboratory stressor. We brought couples ( N = 145) to the lab and randomly assigned 1 partner (the participant) to perform a stressful task. We manipulated whether participants expressed their feelings about the task to their partner (expression vs. no-expression), and whether participants received supportive messages from their partners (as an indicator of partner responsiveness; support vs. no-support). We examined physiological stress responses (cortisol and salivary alpha-amylase [sAA]), negative emotional stress responses (anxiety and self-conscious emotions), and post-task ruminative thoughts. Participants high in EAC showed larger sAA and cortisol responses and reported more negative post-task ruminative thoughts after emotionally expressing to their partners, but partner support mitigated the effect on cortisol. Participants low in EAC showed smaller cortisol responses and reported less negative emotional responses and fewer negative post-task ruminative thoughts after emotionally expressing to their partners. Receiving partner support reduced negative emotional responses for people high in EAC, but increased negative emotional responses for those low in EAC. These results may help explain when and for whom emotional expression is an effective means of coping in the immediate context of a stressor. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Participants low in EAC showed smaller cortisol responses and reported less negative emotional responses and fewer negative post-task ruminative thoughts after emotionally expressing to their partners.,[],['emotional approach coping (EAC'],"['interpersonal emotional expression, partner responsiveness, and emotional approach coping on stress responses', 'physiological stress responses (cortisol and salivary alpha-amylase [sAA]), negative emotional stress responses (anxiety and self-conscious emotions), and post-task ruminative thoughts', 'larger sAA and cortisol responses', 'smaller cortisol responses', 'negative emotional responses']",[],"[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2350025', 'cui_str': 'Physiological Stress Reactivity'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0086209', 'cui_str': 'Emotional Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]",1.0,0.0243718,Participants low in EAC showed smaller cortisol responses and reported less negative emotional responses and fewer negative post-task ruminative thoughts after emotionally expressing to their partners.,"[{'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Kane', 'Affiliation': 'School of Behavioral and Brain Sciences.'}, {'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Wiley', 'Affiliation': 'School of Psychological Sciences.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dunkel Schetter', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Theodore F', 'Initials': 'TF', 'LastName': 'Robles', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000487']
497,32144438,Tripping on nothing: placebo psychedelics and contextual factors.,"RATIONALE
Is it possible to have a psychedelic experience from a placebo alone? Most psychedelic studies find few effects in the placebo control group, yet these effects may have been obscured by the study design, setting, or analysis decisions.
OBJECTIVE
We examined individual variation in placebo effects in a naturalistic environment resembling a typical psychedelic party.
METHODS
Thirty-three students completed a single-arm study ostensibly examining how a psychedelic drug affects creativity. The 4-h study took place in a group setting with music, paintings, coloured lights, and visual projections. Participants consumed a placebo that we described as a drug resembling psilocybin, which is found in psychedelic mushrooms. To boost expectations, confederates subtly acted out the stated effects of the drug and participants were led to believe that there was no placebo control group. The participants later completed the 5-Dimensional Altered States of Consciousness Rating Scale, which measures changes in conscious experience.
RESULTS
There was considerable individual variation in the placebo effects; many participants reported no changes while others showed effects with magnitudes typically associated with moderate or high doses of psilocybin. In addition, the majority (61%) of participants verbally reported some effect of the drug. Several stated that they saw the paintings on the walls ""move"" or ""reshape"" themselves, others felt ""heavy… as if gravity [had] a stronger hold"", and one had a ""come down"" before another ""wave"" hit her.
CONCLUSION
Understanding how context and expectations promote psychedelic-like effects, even without the drug, will help researchers to isolate drug effects and clinicians to maximise their therapeutic potential.",2020,There was considerable individual variation in the placebo effects; many participants reported no changes while others showed effects with magnitudes typically associated with moderate or high doses of psilocybin.,['Thirty-three students'],['placebo'],['5-Dimensional Altered States of Consciousness Rating Scale'],"[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0150450', 'cui_str': 'Altered state of consciousness'}, {'cui': 'C0222045'}]",33.0,0.156322,There was considerable individual variation in the placebo effects; many participants reported no changes while others showed effects with magnitudes typically associated with moderate or high doses of psilocybin.,"[{'ForeName': 'Jay A', 'Initials': 'JA', 'LastName': 'Olson', 'Affiliation': 'Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC, H3A 1A1, Canada. jay.olson@mail.mcgill.ca.'}, {'ForeName': 'Léah', 'Initials': 'L', 'LastName': 'Suissa-Rocheleau', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, QC, H3A 1G1, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lifshitz', 'Affiliation': 'Department of Anthropology, Stanford University, Main Quad, Building 50, 450 Serra Mall, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Raz', 'Affiliation': 'Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC, H3A 1A1, Canada.'}, {'ForeName': 'Samuel P L', 'Initials': 'SPL', 'LastName': 'Veissière', 'Affiliation': 'Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC, H3A 1A1, Canada.'}]",Psychopharmacology,['10.1007/s00213-020-05464-5']
498,29486960,"Effects of short-term, high-frequency repetitive transcranial magnetic stimulation to bilateral dorsolateral prefrontal cortex on smoking behavior and cognition in patients with schizophrenia and non-psychiatric controls.","BACKGROUND
High rates of tobacco smoking and smoking cessation failure in schizophrenia may be related to prefrontal cortical dysfunction. Novel treatment options for tobacco use disorder are needed given the limited efficacy of current pharmacotherapies. Preliminary evidence suggests high-frequency repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsolateral prefrontal cortex (DLPFC) may suppress tobacco craving in smokers with schizophrenia. The goal of this study was to determine effects of rTMS for tobacco craving and cognition using a short-term (3-day) human laboratory paradigm.
METHODS
Bilateral active (20Hz) versus sham rTMS stimulation was administered in a counterbalanced, double-blind, cross-over design to thirteen smokers with schizophrenia and n=14 non-psychiatric smoking controls. Participants were studied at baseline (smoking satiated), after 16h of smoking abstinence, and after smoking reinstatement. Primary outcome measures included tobacco craving, withdrawal and cognition.
RESULTS
Overnight abstinence produced a significant increase in tobacco craving and withdrawal, and impaired verbal memory and visuospatial working memory in both diagnostic groups; these effects were reversed with smoking reinstatement. However, active rTMS did not modify this pattern of results. Moreover, active versus sham rTMS had no significant effects on cognitive outcomes, and was not associated with significant adverse events.
CONCLUSIONS
Our preliminary findings suggest that short-term rTMS administration may not be sufficient enough to modify cognition, craving, and withdrawal outcomes in smokers with schizophrenia (NCT00736710). Longer-term, controlled treatment studies examining effects of rTMS on smoking behaviors and cognition in schizophrenia are warranted.",2018,"Moreover, active versus sham rTMS had no significant effects on cognitive outcomes, and was not associated with significant adverse events.
","['patients with schizophrenia and non-psychiatric controls', 'Participants were studied at baseline (smoking satiated), after 16h of smoking abstinence, and after smoking reinstatement', 'smokers with schizophrenia', 'thirteen smokers with schizophrenia and n=14 non-psychiatric smoking controls']","['short-term, high-frequency repetitive transcranial magnetic stimulation', 'Bilateral active (20Hz) versus sham rTMS stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['cognitive outcomes', 'tobacco craving, withdrawal and cognition', 'tobacco craving and withdrawal, and impaired verbal memory and visuospatial working memory', 'smoking behavior and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}]",13.0,0.0683199,"Moreover, active versus sham rTMS had no significant effects on cognitive outcomes, and was not associated with significant adverse events.
","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Kozak', 'Affiliation': 'Addictions Division, Centre for Addiction and Mental Health (CAMH), Canada; Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, Canada; Institute of Medical Sciences, University of Toronto, Canada. Electronic address: karolina.kozak@camh.ca.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Sharif-Razi', 'Affiliation': 'Addictions Division, Centre for Addiction and Mental Health (CAMH), Canada.'}, {'ForeName': 'Marya', 'Initials': 'M', 'LastName': 'Morozova', 'Affiliation': 'Addictions Division, Centre for Addiction and Mental Health (CAMH), Canada.'}, {'ForeName': 'Erin V', 'Initials': 'EV', 'LastName': 'Gaudette', 'Affiliation': 'Addictions Division, Centre for Addiction and Mental Health (CAMH), Canada.'}, {'ForeName': 'Mera S', 'Initials': 'MS', 'LastName': 'Barr', 'Affiliation': 'Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, Canada; Institute of Medical Sciences, University of Toronto, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, Canada; Institute of Medical Sciences, University of Toronto, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, Canada; Institute of Medical Sciences, University of Toronto, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': 'Addictions Division, Centre for Addiction and Mental Health (CAMH), Canada; Division of Brain and Therapeutics, Department of Psychiatry, University of Toronto, Canada; Institute of Medical Sciences, University of Toronto, Canada.'}]",Schizophrenia research,['10.1016/j.schres.2018.02.015']
499,29487402,Ketamine has distinct electrophysiological and behavioral effects in depressed and healthy subjects.,"Ketamine's mechanism of action was assessed using gamma power from magnetoencephalography (MEG) as a proxy measure for homeostatic balance in 35 unmedicated subjects with major depressive disorder (MDD) and 25 healthy controls enrolled in a double-blind, placebo-controlled, randomized cross-over trial of 0.5 mg/kg ketamine. MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration. Both groups showed increased resting gamma power following ketamine. In MDD subjects, gamma power was not associated with the magnitude of the antidepressant effect. However, baseline gamma power was found to moderate the relationship between post-ketamine gamma power and antidepressant response; specifically, higher post-ketamine gamma power was associated with better response in MDD subjects with lower baseline gamma, with an inverted relationship in MDD subjects with higher baseline gamma. This relationship was observed in multiple regions involved in networks hypothesized to be involved in the pathophysiology of MDD. This finding suggests biological subtypes based on the direction of homeostatic dysregulation and has important implications for inferring ketamine's mechanism of action from studies of healthy controls alone.",2019,"MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration.","['depressed and healthy subjects', '35 unmedicated subjects with major depressive disorder (MDD) and 25 healthy controls enrolled']","['Ketamine', 'ketamine', 'gamma power from magnetoencephalography (MEG', 'placebo']","['depressive symptoms', 'resting gamma power']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}]",35.0,0.0308105,"MDD subjects showed significant improvements in depressive symptoms, and healthy control subjects exhibited modest but significant increases in depressive symptoms for up to 1 day after ketamine administration.","[{'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. nugenta@mail.nih.gov.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Ballard', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'Laboratory of Clinical Investigation, National Institute on Aging, Baltimore, MD, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Brutsche', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0028-2']
500,31982585,Effect of a Surgical Teaching Video on Resident Performance of a Laparoscopic Salpingo-oophorectomy: A Randomized Controlled Trial.,"STUDY OBJECTIVE
To assess the effect of a surgical teaching video on junior resident knowledge and performance of a laparoscopic salpingo-oophorectomy (LSO).
DESIGN
Randomized controlled trial.
SETTING
Urban tertiary care academic obstetrics and gynecology department.
PATIENTS
First- and second-year gynecology residents.
INTERVENTIONS
Access to an education video on LSO for 1 week before performing this surgery in the operating room.
MEASUREMENTS AND MAIN RESULTS
Twenty-four junior residents were recruited and randomized to either the educational video group or traditional residency training group. All participants completed a demographic survey and knowledge questionnaire before performing an LSO, which was video-recorded. Video recordings of surgical performance were analyzed using the Objective Structured Assessment of Technical Skills (OSATS; 20 points) and an LSO-specific tool (30 points). Participants completed a self-assessment questionnaire before completing the procedure. The primary outcome measure was the difference in OSATS scores. The secondary outcomes were the knowledge questionnaire scores and self-assessed confidence scores. There were no significant differences between demographic variables of the 2 groups. The primary outcome revealed no significant differences in mean (standard deviation) OSATS scores (10.64 [2.05] vs 11.55 [1.85], p = .3) or LSO-specific tool scores (16.45 [2.68] vs 17.85 [2.63], p = .24). However, there was a significant difference in mean knowledge scores between the video and the traditional training (8.42 [0.79] vs 7.11 [1.36], p = .01) groups. In addition, residents in the video group had more confidence in their knowledge of pelvic anatomy (3.83 [0.39] vs 3.00 [1.00] out of 5.00, p = .04).
CONCLUSION
For junior learners, the use of an LSO video improved knowledge and confidence in anatomy but did not translate to improved surgical performance in the operating room. Surgical videos are a useful adjunct and complement hands-on technical teaching.",2020,"In addition, residents in the video group had more confidence of their knowledge of pelvic anatomy (3.83/5, SD 0.39 vs 3.00, SD 1.00, p=.04).
","['urban tertiary care academic obstetrics and gynecology department', 'Twenty-four residents', 'First and second year gynecology residents']","['laparoscopic salpingo-oophorectomy (LSO', 'Surgical Teaching Video', 'Laparoscopic Salpingo-oophorectomy', 'LSO video', 'educational video group or traditional residency training', 'Access to an education video on LSO', 'surgical teaching video']","['confidence of their knowledge of pelvic anatomy', 'OSATS scores', 'mean knowledge scores', 'mean OSATS scores', 'knowledge questionnaire scores and self-assessed confidence scores', 'surgical performance', 'LSO specific tool scores']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department (environment)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}]","[{'cui': 'C2960363', 'cui_str': 'Laparoscopic salpingo-oophorectomy'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",24.0,0.143267,"In addition, residents in the video group had more confidence of their knowledge of pelvic anatomy (3.83/5, SD 0.39 vs 3.00, SD 1.00, p=.04).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Norris', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore).'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Papillon-Smith', 'Affiliation': 'Department of Obstetrics and Gynaecology, McGill University (Dr. Papillon-Smith); Department of Obstetrics and Gynaecology, Royal Victoria Hospital (Dr. Papillon-Smith), Montreal, Quebec, Canada.'}, {'ForeName': 'Louise-Helene', 'Initials': 'LH', 'LastName': 'Gagnon', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Sunnybrook Health Sciences Centre (Dr. Gagnon).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Jacobson', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Mount Sinai Hospital (Drs. Jacobson and Sobel).'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Sobel', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Mount Sinai Hospital (Drs. Jacobson and Sobel).'}, {'ForeName': 'Eliane M', 'Initials': 'EM', 'LastName': 'Shore', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Toronto (Drs. Norris, Gagnon, Jacobson, Sobel, and Shore); Department of Obstetrics and Gynaecology, Division of Gynecologic Surgery and Pelvic Medicine, St. Michael's Hospital (Dr. Shore), Toronto, Ontario. Electronic address: eliane.shore@unityhealth.to.""}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.01.010']
501,31980242,"A prospective, randomized study comparing ultrasound versus fluoroscopic guided femoral arterial access in noncardiac vascular patients.","OBJECTIVE
The aim of our prospective, single-center, randomized study was to compare the procedural outcomes and complication rates of ultrasound (US)-guided common femoral artery (CFA) access to fluoroscopic guidance in noncardiac procedures.
METHODS
A total of 635 patients undergoing femoral access for noncardiac diagnostic or interventional procedures were randomized 1:1 to receive either fluoroscopic or US-guided access. The primary end point of the study was successful CFA cannulation. Secondary end points included the first-pass success rate, time to sheath insertion, and accidental venipunctures rate. Both short (24 hours) and midterm (30-90 days postprocedure) access complications were assessed by practitioners blinded to patient randomization.
RESULTS
Successful CFA cannulation occurred in 93% of US-guided procedures compared with 86% of fluoroscopy-guided access (P = .002). US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy. Rates of complications did not differ at 24 hours (1% vs 1%; P = .99) or 30 to 90 days (2% vs 4%; P = .15) in fluoroscopy vs US-guided access. When access was performed by vascular surgery trainees (residents and fellows), US guidance retained superior rates of successful CFA cannulation compared to fluoroscopy guided access (n = 298; 96% vs 89%; P = .03). Trainees' time to achieve CFA cannulation was similar to attendings' when using US guidance (median, 85 vs 77 seconds; P = .14); however, with fluoroscopy, trainees' times were significantly longer than those of attendings (137 vs 86 seconds; P = .001).
CONCLUSIONS
In comparison to fluoroscopy, US-guided CFA cannulation had a higher rate of success, faster cannulation, and fewer venipunctures in the absence of increased complications.",2020,"US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy.","['noncardiac vascular patients', '635 patients undergoing femoral access for noncardiac diagnostic or interventional procedures']","['ultrasound versus fluoroscopic guided femoral arterial access', 'fluoroscopic or US-guided access', 'fluoroscopy, US-guided CFA cannulation', 'ultrasound (US)-guided common femoral artery (CFA']","['inadvertent venipunctures', 'procedural outcomes and complication rates', 'first-pass success rate, time to sheath insertion, and accidental venipunctures rate', 'access complications', 'successful CFA cannulation', 'Successful CFA cannulation', 'median time to cannulation', 'Rates of complications', 'rates of first-attempt success', ""Trainees' time to achieve CFA cannulation"", 'rate of success, faster cannulation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0447105', 'cui_str': 'Common femoral artery (body structure)'}]","[{'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0521129', 'cui_str': 'Accidental (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",635.0,0.150195,"US guidance was associated with increased rates of first-attempt success (74% vs 42%; P < .001), fewer inadvertent venipunctures (2% vs 10 %; P < .001), and decreased median time to cannulation (80 vs 100 seconds; P < .001) compared with fluoroscopy.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stone', 'Affiliation': 'Division of Vascular Surgery, Vanderbilt University, Nashville, Tenn; Division of Vascular Surgery, West Virginia University (Charleston Division), Charleston, WV. Electronic address: pstone0627@yahoo.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Division of Vascular Surgery, West Virginia University (Charleston Division), Charleston, WV.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'Charleston Area Medical Center Health Education and Research Institute, Charleston, WV.'}, {'ForeName': 'Jerri', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Charleston Area Medical Center Health Education and Research Institute, Charleston, WV.'}]",Journal of vascular surgery,['10.1016/j.jvs.2019.09.051']
502,30077569,Early Response to Anti-Vascular Endothelial Growth Factor and Two-Year Outcomes Among Eyes With Diabetic Macular Edema in Protocol T.,"PURPOSE
Assess associations of 2-year visual acuity (VA) outcomes with VA and optical coherence tomography central subfield thickness (CST) after 12 weeks of anti-vascular endothelial growth factor treatment for diabetic macular edema in DRCR.net Protocol T.
DESIGN
Randomized clinical trial.
METHODS
Setting: Multicenter (89 U.S. sites).
PATIENT POPULATION
Eyes with VA and CST data from baseline and 12-week visits (616 of 660 eyes randomized [93.3%]).
INTERVENTION
Six monthly injections of 2.0 mg aflibercept, 1.25 mg bevacizumab, or 0.3 mg ranibizumab; subsequent injections and focal/grid laser as needed for stability.
MAIN OUTCOME MEASURES
Change in VA from baseline and VA letter score at 2 years.
RESULTS
Twelve-week VA response was associated with 2-year change in VA and 2-year VA letter score for each drug (P < .001) but with substantial individual variability (multivariable R 2 = 0.38, 0.29, and 0.26 for 2-year change with aflibercept, bevacizumab, and ranibizumab, respectively). Among eyes with less than 5-letter gain at 12 weeks, the percentages of eyes gaining 10 or more letters from baseline at 2 years were 42% (20 of 48), 31% (21 of 68), and 47% (28 of 59), and median 2-year VA was 20/32, 20/32, and 20/25, in the aflibercept, bevacizumab, and ranibizumab groups, respectively. Twelve-week CST response was not strongly associated with 2-year outcomes.
CONCLUSIONS
A suboptimal response at 12 weeks did not preclude meaningful vision improvement (ie, ≥ 10-letter gain) in many eyes at 2 years. Eyes with less than 5-letter gain at 12 weeks often had good VA at 2 years without switching therapies.",2018,"RESULTS
Twelve-week VA response was associated with 2-year change in VA and 2-year VA letter score for each drug (P < .001) but with substantial individual variability (multivariable R 2 = 0.38, 0.29, and 0.26 for 2-year change with aflibercept, bevacizumab, and ranibizumab, respectively).","['Setting: Multicenter (89\xa0U.S. sites', 'Eyes with VA and CST data from baseline and 12-week visits (616 of 660 eyes randomized [93.3', 'Eyes', 'diabetic macular edema in DRCR.net Protocol T']","['anti-vascular endothelial growth factor treatment', 'aflibercept, 1.25\xa0mg bevacizumab, or 0.3\xa0mg ranibizumab', 'VA and optical coherence tomography central subfield thickness (CST', 'aflibercept, bevacizumab']","['2-year change in VA and 2-year VA letter score', 'meaningful vision improvement (ie, ≥ 10-letter gain', 'median 2-year VA']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0560172', 'cui_str': 'cSt'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",660.0,0.344014,"RESULTS
Twelve-week VA response was associated with 2-year change in VA and 2-year VA letter score for each drug (P < .001) but with substantial individual variability (multivariable R 2 = 0.38, 0.29, and 0.26 for 2-year change with aflibercept, bevacizumab, and ranibizumab, respectively).","[{'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Wesley T', 'Initials': 'WT', 'LastName': 'Beaulieu', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA. Electronic address: drcrstat8@jaeb.org.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Glassman', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Blinder', 'Affiliation': 'The Retina Institute, St Louis, Missouri, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Bressler', 'Affiliation': 'Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Victor H', 'Initials': 'VH', 'LastName': 'Gonzalez', 'Affiliation': 'Valley Retina Institute, McAllen, Texas, USA.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Jampol', 'Affiliation': 'Feinberg School of Medicine, Northwestern University Medical School, Chicago, Illinois, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Melia', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Sun', 'Affiliation': 'Joslin Diabetes Center, Beetham Eye Institute, Harvard Department of Ophthalmology, Boston, Massachusetts, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Wells', 'Affiliation': 'Palmetto Retina Center, Columbia, South Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2018.07.030']
503,29876282,Repairing the brain with physical exercise: Cortical thickness and brain volume increases in long-term pediatric brain tumor survivors in response to a structured exercise intervention.,"There is growing evidence that exercise induced experience dependent plasticity may foster structural and functional recovery following brain injury. We examined the efficacy of exercise training for neural and cognitive recovery in long-term pediatric brain tumor survivors treated with radiation. We conducted a controlled clinical trial with crossover of exercise training (vs. no training) in a volunteer sample of 28 children treated with cranial radiation for brain tumors (mean age = 11.5 yrs.; mean time since diagnosis = 5.7 yrs). The endpoints were anatomical T1 MRI data and multiple behavioral outcomes presenting a broader analysis of structural MRI data across the entire brain. This included an analysis of changes in cortical thickness and brain volume using automated, user unbiased approaches. A series of general linear mixed effects models evaluating the effects of exercise training on cortical thickness were performed in a voxel and vertex-wise manner, as well as for specific regions of interest. In exploratory analyses, we evaluated the relationship between changes in cortical thickness after exercise with multiple behavioral outcomes, as well as the relation of these measures at baseline. Exercise was associated with increases in cortical thickness within the right pre and postcentral gyri. Other notable areas of increased thickness related to training were present in the left pre and postcentral gyri, left temporal pole, left superior temporal gyrus, and left parahippocampal gyrus. Further, we observed that compared to a separate cohort of healthy children, participants displayed multiple areas with a significantly thinner cortex prior to training and fewer differences following training, indicating amelioration of anatomical deficits. Partial least squares analysis (PLS) revealed specific patterns of relations between cortical thickness and various behavioral outcomes both after training and at baseline. Overall, our results indicate that exercise training in pediatric brain tumor patients treated with radiation has a beneficial impact on brain structure. We argue that exercise training should be incorporated into the development of neuro-rehabilitative treatments for long-term pediatric brain tumor survivors and other populations with acquired brain injury. (ClinicalTrials.gov, NCT01944761).",2018,"Other notable areas of increased thickness related to training were present in the left pre and postcentral gyri, left temporal pole, left superior temporal gyrus, and left parahippocampal gyrus.",['volunteer sample of 28 children treated with cranial radiation for brain tumors (mean age\u202f=\u202f11.5\u202fyrs.; mean time since diagnosis\u202f=\u202f5.7\u202fyrs'],"['exercise training', 'structured exercise intervention', 'exercise training (vs. no training', 'radiation']","['cortical thickness', 'anatomical T1 MRI data and multiple behavioral outcomes presenting a broader analysis of structural MRI data across the entire brain']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0006118', 'cui_str': 'Brain Tumors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1269537', 'cui_str': 'Entire brain'}]",28.0,0.0274412,"Other notable areas of increased thickness related to training were present in the left pre and postcentral gyri, left temporal pole, left superior temporal gyrus, and left parahippocampal gyrus.","[{'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Szulc-Lerch', 'Affiliation': 'Neurosciences and Mental Health, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada; Department of Pediatrics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia B', 'Initials': 'CB', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences and Mental Health, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jovanka', 'Initials': 'J', 'LastName': 'Skocic', 'Affiliation': 'Neurosciences and Mental Health, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Lerch', 'Affiliation': 'Neurosciences and Mental Health, Hospital for Sick Children, Toronto, Ontario, Canada; Mouse Imaging Centre, Hospital for Sick Children, Toronto, Ontario, Canada; Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences and Mental Health, Hospital for Sick Children, Toronto, Ontario, Canada; Department of Psychology, University of Toronto, Toronto, Ontario, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2018.02.021']
504,31984598,"Efficacy and tolerability of tirzepatide, a dual glucose-dependent insulinotropic peptide and glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes: A 12-week, randomized, double-blind, placebo-controlled study to evaluate different dose-escalation regimens.","AIM
To assess the efficacy and tolerability of tirzepatide treatment using three different dose-escalation regimens in patients with type 2 diabetes.
MATERIALS AND METHODS
In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo. The tirzepatide dose groups and dose-escalation regimens were: 12 mg (4 mg weeks 0-3; 8 mg weeks 4-7; 12 mg weeks 8-11), 15 mg-1 (2.5 mg weeks 0-1; 5 mg weeks 2-3; 10 mg weeks 4-7; 15 mg weeks 8-11) and 15 mg-2 (2.5 mg weeks 0-3; 7.5 mg weeks 4-7; 15 mg weeks 8-11). The primary objective was to compare tirzepatide with placebo in HbA1c change from baseline at 12 weeks.
RESULTS
Overall, 111 patients were randomized: placebo, 26; tirzepatide 12 mg, 29; tirzepatide 15 mg-1, 28; tirzepatide 15 mg-2, 28. The mean age was 57.4 years, HbA1c 8.4% and body mass index 31.9 kg/m 2 . At week 12, absolute HbA1c change from baseline (SE) was greater in the tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]). The incidence of nausea was: placebo, 7.7%; 12 mg group, 24.1%; 15 mg-1 group, 39.3%; 15 mg-2 group, 35.7%. Three patients discontinued the treatment because of adverse events, one from each of the placebo, 12 mg and 15 mg-1 groups.
CONCLUSIONS
Tirzepatide treatment for 12 weeks resulted in clinically significant reductions in HbA1c. This suggests that lower starting doses and smaller dose increments are associated with a more favourable side effect profile.",2020,"At Week 12, absolute HbA1c change from baseline (SE) was greater in tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]).","['111 patients were randomised', 'Patients with Type 2 Diabetes', 'Mean age was 57.4\u2009years, HbA1c 8.4%, and BMI 31.9 kg/m 2 ', 'patients with type 2 diabetes']","['Placebo', 'placebo (placebo', 'Tirzepatide, a Dual GIP and GLP-1 Receptor Agonist', 'tirzepatide', 'placebo', 'tirzepatide or placebo']","['incidence of nausea', 'efficacy and tolerability', 'Efficacy and Tolerability', 'absolute HbA1c change from baseline (SE']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517876', 'cui_str': '8.4'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",111.0,0.266328,"At Week 12, absolute HbA1c change from baseline (SE) was greater in tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]).","[{'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles California, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Van', 'Affiliation': 'Diabetes Research Center, Tustin, California.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Benson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bray', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Zvonko', 'Initials': 'Z', 'LastName': 'Milicevic', 'Affiliation': 'Eli Lilly and Company, Vienna, Austria.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Urva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Robins', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13979']
505,31984623,Association of increased hepatic insulin clearance and change in serum triglycerides or β-hydroxybutyrate concentration via the sodium/glucose-cotransporter 2 inhibitor tofogliflozin.,"AIMS
Obesity and hepatic fat accumulation diminish hepatic insulin clearance, which can cause hyperinsulinaemia. Sodium/glucose-cotransporter 2 inhibitors (SGLT2-is) improve insulin resistance and hyperinsulinaemia by weight loss via increased urinary glucose excretion in type 2 diabetes. However, there are few reports of the influence of SGLT2-is on hepatic insulin clearance. We examined the impact of an SGLT2-i on hepatic insulin clearance and explored the clinical influence associated with changes in hepatic insulin clearance via an SGLT2-i and the mechanism of the effects of SGLT2-i.
MATERIALS AND METHODS
Data were analysed from 419 patients with type 2 diabetes controlled by diet and exercise. Patients received a placebo or the SGLT2-i tofogliflozin (TOFO) (placebo: n = 56; TOFO: n = 363) orally once daily for ≥24 weeks. Hepatic insulin clearance was calculated from the ratio of areas under the curve (AUC) of C-peptide and insulin levels derived from oral meal tolerance test data (C-peptide AUC 0-120 min /insulin AUC 0-120 min : HIC CIR ). The correlation of HIC CIR via the SGLT2-i with other clinical variables was analysed using multivariate analysis.
RESULTS
HIC CIR was significantly increased via TOFO at week 24. Furthermore, with TOFO insulin and triglyceride (TG) levels were significantly reduced (P < 0.001) and β-hydroxybutyrate (BHB) was significantly elevated (P < 0.001). Changes in HIC CIR were significantly correlated with changes in TG and BHB via TOFO.
CONCLUSIONS
Increased HIC CIR was significantly associated with reduced TG via TOFO and contributed to the greater increase in BHB compared with placebo in addition to the correction of hyperinsulinaemia.",2020,"Furthermore, with TOFO insulin and triglyceride (TG) levels were significantly reduced (p <0.001) and β-hydroxybutyrate (BHB) was significantly elevated (p <0.001).","['419 patients with type 2 diabetes controlled by diet and exercise', 'type 2 diabetes']","['placebo', 'Sodium/glucose-cotransporter 2 inhibitors (SGLT2-is', 'SGLT2-i', 'placebo or the SGLT2-i tofogliflozin (TOFO) (placebo: n\xa0=\xa056; TOFO: n\xa0=\xa0363) orally once daily for ≥24\u2009weeks']","['TOFO insulin and triglyceride (TG) levels', 'β-hydroxybutyrate (BHB', 'Hepatic insulin clearance', 'HIC CIR', 'hepatic insulin clearance', 'BHB', 'hepatic insulin clearance and change in serum triglycerides or β-hydroxybutyrate concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3501434'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",419.0,0.0530782,"Furthermore, with TOFO insulin and triglyceride (TG) levels were significantly reduced (p <0.001) and β-hydroxybutyrate (BHB) was significantly elevated (p <0.001).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Clinical Data Science Dept., Kowa Co., Ltd., Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Osawa', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Furukawa', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13980']
506,31980416,Is Dual-Axis Rotational Coronary Angiography Radiation Dose Reduction Achievable in a Population with 100% Suspected Coronary Artery Disease? A Randomized Trial.,"BACKGROUND
Previous studies have shown a reduction in radiation dose and contrast volume using dual-axis rotational coronary angiography (DARCA), but this has not been replicated in a population with 100% coronary artery disease (CAD).
OBJECTIVE
To find if DARCA dose reduction is achievable in this population, we sought to compare the radiation dose, contrast volume, and procedure time between DARCA and conventional coronary angiography (CCA) techniques in a setting characterized by a prevalence of 100% suspected coronary artery disease.
METHODS
An all-comer, prospective, randomized, open-label trial was conducted. Cine acquisition dose-area product (DAP), cumulative air kerma (AK), effective dose (E), fluoroscopic time, contrast volume, AK, cine acquisition DAP (CADAP), fluoroscopic DAP (F-DAP), and total DAP were compared between DARCA and CCA groups.
RESULTS
We included 503 consecutive patients with suspected CAD. 252 were assigned to DARCA and 251 to CCA. Stable coronary artery disease was reported in 465 cases and non-ST elevation acute coronary syndrome in 38. Mean age: 61.88 ± 11.2 years, male gender 70.2%. DARCA arm patients showed lower total E dose (6.85 [4.55-10.83] vs. 7.91 [5.58-11.94] Sv; P = .0023), and cine E (3.00 [2.00-4.00] vs. 4.00 [3.00-5.00] Sv; P < .0001). Total DAP was also lower (40.3 [26.8-63.7] vs. 46.5 [32.8-70.2] Gycm 2 ; P = .0023), as a consequence of a lower CADAP (16.3 [10.5-22.9] vs. 23.4 [17.4-32.0] Gycm 2 ; P < .0001), with lower AK (367 [248-1497] vs. 497 [381-1827] mGy; P < .0001), with less contrast medium used (90 [60.0-106.0] vs. 100 [75.0-120.0] mL; P = .014).
CONCLUSION
In a population with 100% suspected coronary artery disease, DARCA provides accurate information required in CAD, is safe, and results in a significant decrease in contrast material volume and radiation dose compared with CCA. The required extra projections did not neutralize the DARCA radiation dose and contrast volume reduction achievements.",2020,"Total DAP was also lower (40.3 [26.8-63.7] vs. 46.5 [32.8-70.2] Gycm 2 ; P = .0023), as a consequence of a lower CADAP (16.3 [10.5-22.9] vs. 23.4","['503 consecutive patients with suspected CAD', 'population with 100% coronary artery disease (CAD', 'Mean age: 61.88 ± 11.2\xa0years, male gender 70.2', '465 cases and non-ST elevation acute coronary syndrome in 38']","['DARCA and conventional coronary angiography (CCA) techniques', 'dual-axis rotational coronary angiography (DARCA', 'DARCA', 'Dual-Axis Rotational Coronary Angiography Radiation']","['Total DAP', 'lower total E dose', 'Cine acquisition dose-area product (DAP), cumulative air kerma (AK), effective dose (E), fluoroscopic time, contrast volume, AK, cine acquisition DAP (CADAP), fluoroscopic DAP (F-DAP), and total DAP', 'Stable coronary artery disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517531', 'cui_str': '11.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]",503.0,0.0401866,"Total DAP was also lower (40.3 [26.8-63.7] vs. 46.5 [32.8-70.2] Gycm 2 ; P = .0023), as a consequence of a lower CADAP (16.3 [10.5-22.9] vs. 23.4","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Szarfer', 'Affiliation': 'Chief Coronary Care Unit, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina. Electronic address: jorge@szarfer.com.ar.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Albornoz', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Analía', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Vielka', 'Initials': 'V', 'LastName': 'Yurko', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Blanco', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Indavere', 'Affiliation': 'Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Gigena', 'Affiliation': 'Chief Cat. Lab, Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gagliardi', 'Affiliation': 'Chief Cardiology Division, Hospital Argerich, Buenos Aires, Argentina.'}, {'ForeName': 'Alejandro García', 'Initials': 'AG', 'LastName': 'Escudero', 'Affiliation': 'President of Board of Directors, ""Hospital El Cruce"", Buenos Aires, Argentina.'}]",Journal of medical imaging and radiation sciences,['10.1016/j.jmir.2019.12.009']
507,31976633,Sedentary Behaviour and Diabetes Information as a Source of Motivation to Reduce Daily Sitting Time in Office Workers: A Pilot Randomised Controlled Trial.,"BACKGROUND
Using the motivational phase of the Health Action Process Approach (HAPA), this study examined whether sedentary behaviour and diabetes information is a meaningful source of motivation to reduce daily sitting time among preintending office workers.
METHODS
Participants (N = 218) were randomised into HAPA-intervention (sedentary behaviour), HAPA-attention control (physical activity), or control (no treatment) conditions. Following treatment, purpose-built sedentary-related HAPA motivational constructs (risk perception, outcome expectancies, self-efficacy) and goal intentions were assessed. Only participants who had given little thought to how much time they spent sitting (preintenders) were used in subsequent analyses (n = 96).
RESULTS
Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p 2 values ≥.08). Only self-efficacy (β range = 0.39-0.50) made significant and unique contributions to work and leisure-time-related goal intentions, explaining 11-21 per cent of the response variance.
CONCLUSIONS
A brief, HAPA-based online intervention providing information regarding sedentary behaviour and diabetes risk may be an effective source of motivation.",2020,"RESULTS
Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p 2 values ≥.08).","['Office Workers', 'Participants (N\xa0=\xa0218']","['HAPA-intervention (sedentary behaviour), HAPA-attention control (physical activity), or control (no treatment) conditions', 'HAPA-based online intervention']","['HAPA motivational constructs (risk perception, outcome expectancies, self-efficacy) and goal intentions', 'number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies', 'goal intentions']","[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",218.0,0.0560881,"RESULTS
Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p 2 values ≥.08).","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rollo', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12190']
508,32406601,Goal achievement of HbA1c and LDL-cholesterol in a randomized trial comparing colesevelam with ezetimibe: GOAL-RCT.,"AIM
To compare the efficacy and safety of colesevelam and ezetimibe as second-line low density lipoprotein-cholesterol (LDL-c)-lowering options in type 2 diabetes (T2D).
MATERIALS AND METHODS
GOAL-RCT is a 24-week, open-label, randomized, pragmatic clinical trial. Subjects with T2D with uncontrolled HbA1c (7.1%-10%) and LDL-c (>2.0 mmol/L) were randomized 1:1 to colesevelam 3.75 g or ezetimibe 10 mg daily. The primary composite outcome was the proportion of participants achieving an LDL-c target of ≤2.0 mmol/L and HbA1c target of ≤7.0%. Intention to treat analysis was performed.
RESULTS
Two hundred subjects were enrolled: mean age 59 ± 10 years; mean HbA1c 8.0%; mean LDL-c 2.5 mmol/L; 97% on statin therapy. The primary composite outcome was achieved by similar proportions of participants with colesevelam (14.6%) and ezetimibe (10.5%) (P non-inferiority < .001, P superiority = .41). LDL-c reduction from baseline was less with colesevelam compared with ezetimibe (14.0% vs. 23.2%, P < .01), as was the proportion of subjects achieving an LDL-c target of ≤2.0 mmol/L (47.6% and 67.0%, respectively; P = .007). Mean HbA1c was reduced with colesevelam (-0.26 ± 0.10%), while no change was observed with ezetimibe (difference P = .06). Adverse events and discontinuation rates were higher for colesevelam (20.2% and 31.1%) compared with ezetimibe (7.2% and 6.2%), respectively.
CONCLUSIONS
Among subjects with T2D, the initiation of colesevelam or ezetimibe led to similar achievement of primary composite outcome (LDL-c and HbA1c within target), with ezetimibe recording a greater LDL-c reduction and better tolerability than colesevelam.",2020,"LDL-c reduction from baseline was less with colesevelam compared to ezetimibe (14.0% vs. 23.2%, p < 0.01), as was the proportion of subjects achieving LDL-c target ≤2.0 mmol/L (47.6% and 67.0%, respectively; p = 0.007).","['Subjects with T2D with uncontrolled A1C (7.1-10%) and LDL-c (>2.0\u2009mmol/L', '200 subjects were enrolled: mean age 59\u2009±\u200910\u2009years; mean A1C 8.0%; mean LDL-c 2.5\u2009mmol/L; 97% on statin therapy', 'subjects with T2D, the initiation of colesevelam or', 'type 2 diabetes (T2D']","['colesevelam and ezetimibe', 'Colesevelam vs. Ezetimibe', 'colesevelam 3.75\u2009g or ezetimibe 10\u2009mg daily', 'ezetimibe']","['Mean A1C', 'proportion of participants achieving LDL-c target ≤2.0\u2009mmol/L and A1C target ≤7.0', 'LDL-c reduction', 'efficacy and safety', 'similar proportion of participants with colesevelam', 'LDL-c reduction and better toleratability', 'Adverse events (AE) and discontinuation rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C1166438', 'cui_str': 'ezetimibe 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",200.0,0.101302,"LDL-c reduction from baseline was less with colesevelam compared to ezetimibe (14.0% vs. 23.2%, p < 0.01), as was the proportion of subjects achieving LDL-c target ≤2.0 mmol/L (47.6% and 67.0%, respectively; p = 0.007).","[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Dishay', 'Initials': 'D', 'LastName': 'Jiandani', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Karri', 'Initials': 'K', 'LastName': 'Venn', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Al-Asaad', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Hasnain', 'Initials': 'H', 'LastName': 'Khandwala', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Steen', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Abdel-Salam', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14084']
509,29244111,Serum Albumin as a Prognostic Marker for Serious Non-AIDS Endpoints in the Strategic Timing of Antiretroviral Treatment (START) Study.,"Background
Serum albumin may be used to stratify human immunodeficiency virus (HIV)-infected persons with high CD4 count according to their risk of serious non-AIDS endpoints.
Methods
Cox proportional hazards models were used to analyze the risk of serious non-AIDS events in the Strategic Timing of Antiretroviral Treatment (START) study (NCT00867048) with serum albumin as a fixed and time-updated predictor. Models with exclusion of events during initial follow-up years were built to assess the ability of serum albumin to predict beyond shorter periods of time. Secondarily, we considered hospitalizations and AIDS events.
Results
Among 4576 participants, 71 developed a serious non-AIDS event, 788 were hospitalized, and 63 experienced an AIDS event. After adjusting for a range of variables associated with hypoalbuminemia, higher baseline serum albumin (per 1 g/dL) was associated with a decreased risk of serious non-AIDS events (hazard ratio, 0.37 [95% confidence interval, .20-.71]; P = .002). Similar results were obtained in a time-updated model, after controlling for interleukin 6, and after excluding initial follow-up years. Serum albumin was independently associated with hospitalization but not with risk of AIDS.
Conclusions
A low serum albumin level is a predictor for short- and long-term serious non-AIDS events, and may be a useful marker of risk of noncommunicable diseases, particularly in resource-limited settings.",2018,"Serum albumin was independently associated with hospitalization but not with risk of AIDS.
","['4576 participants, 71 developed a serious non-AIDS event, 788 were hospitalized, and 63 experienced an AIDS event']",[],"['risk of serious non-AIDS events', 'Serum albumin']","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}]",4576.0,0.0290297,"Serum albumin was independently associated with hospitalization but not with risk of AIDS.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ronit', 'Affiliation': 'Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota.'}, {'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': 'Infectious Diseases and Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Enhancing Care Foundation, Durban University of Technology, South Africa.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Delory', 'Affiliation': 'Department of Infectious Diseases, Hospital Saint Louis, Assistance Publique-Hôpitaux de Paris, France.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Caldeira', 'Affiliation': 'Clínica Universitária de Doenças Infecciosas, Faculty of Medicine, Santa Maria University Hospital, University of Lisbon, Portugal.'}, {'ForeName': 'Nicaise', 'Initials': 'N', 'LastName': 'Ndembi', 'Affiliation': 'Institute of Human Virology Nigeria, Abuja.'}, {'ForeName': 'Jens D', 'Initials': 'JD', 'LastName': 'Lundgren', 'Affiliation': 'CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Phillips', 'Affiliation': 'Research Department of Infection and Population Health, University College London Medical School, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of infectious diseases,['10.1093/infdis/jix350']
510,32406573,Efficacy and safety of lobeglitazone versus sitagliptin as an add-on to metformin in patients with type 2 diabetes with two or more components of metabolic syndrome over 24 weeks.,"We aimed to evaluate the efficacy and safety profile of lobeglitazone compared with sitagliptin as an add-on to metformin in patients with type 2 diabetes as well as other components of metabolic syndrome. Patients inadequately controlled by metformin were randomly assigned to lobeglitazone (0.5 mg, n = 121) or sitagliptin (100 mg, n = 126) for 24 weeks. The mean changes in HbA1c of the lobeglitazone and sitagliptin groups were -0.79% and -0.86%, respectively; the between-group difference was 0.08% (95% confidence interval, -0.14% to 0.30%), showing non-inferiority. The proportion of patients having two or more factors of other metabolic syndrome components decreased to a greater extent in the lobeglitazone group than in the sitagliptin group (-11.9% vs. -4.8%; P < .0174). Favourable changes in the lipid metabolism were also observed with lobeglitazone, which had a similar safety profile to sitagliptin. Lobeglitazone was comparable with sitagliptin as an add-on to metformin in terms of efficacy and safety.",2020,Lobeglitazone was comparable to sitagliptin as an add-on to metformin in terms of their efficacy and safety.,"['type 2 diabetes with metabolic syndrome over 24\u2009weeks', 'patients with type 2 diabetes mellitus (T2DM', 'Patients inadequately controlled by']","['Lobeglitazone', 'lobeglitazone', 'metformin', 'sitagliptin', 'lobeglitazone versus sitagliptin']","['lipid metabolism', 'metabolic syndrome components', 'Efficacy and safety', 'efficacy and safety profile', 'efficacy and safety']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}]","[{'cui': 'C2744790', 'cui_str': 'lobeglitazone'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",126.0,0.0305888,Lobeglitazone was comparable to sitagliptin as an add-on to metformin in terms of their efficacy and safety.,"[{'ForeName': 'Sin Gon', 'Initials': 'SG', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyoung Jin', 'Initials': 'KJ', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kun Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Chun', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Kyong Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kyung Mook', 'Initials': 'KM', 'LastName': 'Choi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, South Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Ji-Oh', 'Initials': 'JO', 'LastName': 'Mok', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, South Korea.'}, {'ForeName': 'Hyoung Woo', 'Initials': 'HW', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, South Korea.'}, {'ForeName': 'Ji A', 'Initials': 'JA', 'LastName': 'Seo', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea.'}, {'ForeName': 'Bong-Soo', 'Initials': 'BS', 'LastName': 'Cha', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Ho Sang', 'Initials': 'HS', 'LastName': 'Shon', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Catholic University of Daegu School of Medicine, Daegu, South Korea.'}, {'ForeName': 'Dong Seop', 'Initials': 'DS', 'LastName': 'Choi', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Doo Man', 'Initials': 'DM', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14085']
511,31974825,Testing individual baroreflex responses to hypoxia-induced peripheral chemoreflex stimulation.,"INTRODUCTION
Baroreflexes and peripheral chemoreflexes control efferent autonomic activity making these reflexes treatment targets for arterial hypertension. The literature on their interaction is controversial, with suggestions that their individual and collective influence on blood pressure and heart rate regulation is variable. Therefore, we applied a study design that allows the elucidation of individual baroreflex-chemoreflex interactions.
METHODS
We studied nine healthy young men who breathed either normal air (normoxia) or an air-nitrogen-carbon dioxide mixture with decreased oxygen content (hypoxia) for 90 min, with randomization to condition, followed by a 30-min recovery period and then exposure to the other condition for 90 min. Multiple intravenous phenylephrine bolus doses were applied per condition to determine phenylephrine pressor sensitivity as an estimate of baroreflex blood pressure buffering and cardiovagal baroreflex sensitivity (BRS).
RESULTS
Hypoxia reduced arterial oxygen saturation from 98.1 ± 0.4 to 81.0 ± 0.4% (p < 0.001), raised heart rate from 62.9 ± 2.1 to 76.0 ± 3.6 bpm (p < 0.001), but did not change systolic blood pressure (p = 0.182). Of the nine subjects, six had significantly lower BRS in hypoxia (p < 0.05), two showed a significantly decreased pressor response, and three showed a significantly increased pressor response to phenylephrine in hypoxia, likely through reduced baroreflex buffering (p < 0.05). On average, hypoxia decreased BRS by 6.4 ± 0.9 ms/mmHg (19.9 ± 2.0 vs. 14.12 ± 1.6 ms/mmHg; p < 0.001) but did not change the phenylephrine pressor response (p = 0.878).
CONCLUSION
We applied an approach to assess individual baroreflex-chemoreflex interactions in human subjects. A subgroup exhibited significant impairments in baroreflex blood pressure buffering and BRS with peripheral chemoreflex activation. The methodology may have utility in elucidating individual pathophysiology and in targeting treatments modulating baroreflex or chemoreflex function.",2020,"RESULTS
Hypoxia reduced arterial oxygen saturation from 98.1 ± 0.4 to 81.0 ± 0.4% (p < 0.001), raised heart rate from 62.9 ± 2.1 to 76.0 ± 3.6 bpm (p < 0.001), but did not change systolic blood pressure (p = 0.182).","['human subjects', 'arterial hypertension', 'nine healthy young men who breathed either normal air (normoxia) or an']","['air-nitrogen-carbon dioxide mixture with decreased oxygen content (hypoxia', 'phenylephrine']","['baroreflex blood pressure buffering and cardiovagal baroreflex sensitivity (BRS', 'baroreflex blood pressure buffering and BRS with peripheral chemoreflex activation', 'systolic blood pressure', 'baroreflex buffering', 'BRS in hypoxia', 'blood pressure and heart rate regulation', 'Hypoxia reduced arterial oxygen saturation', 'raised heart rate', 'pressor response', 'phenylephrine pressor response']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2711000', 'cui_str': 'SaO2 - Arterial oxygen saturation'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]",9.0,0.0254132,"RESULTS
Hypoxia reduced arterial oxygen saturation from 98.1 ± 0.4 to 81.0 ± 0.4% (p < 0.001), raised heart rate from 62.9 ± 2.1 to 76.0 ± 3.6 bpm (p < 0.001), but did not change systolic blood pressure (p = 0.182).","[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Kronsbein', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Darius A', 'Initials': 'DA', 'LastName': 'Gerlach', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Heusser', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Hoff', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Diedrich', 'Affiliation': 'Division of Medicine, Division of Clinical Pharmacology, Autonomic Dysfunction Service, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Heimo', 'Initials': 'H', 'LastName': 'Ehmke', 'Affiliation': 'Institute of Cellular and Integrative Physiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR) and Chair of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'Department of Cardiovascular Aerospace Medicine, Institute of Aerospace Medicine, German Aerospace Center (DLR), 51147, Cologne, Germany. jens.tank@dlr.de.'}]",Clinical autonomic research : official journal of the Clinical Autonomic Research Society,['10.1007/s10286-019-00660-6']
512,30638738,"Essential amino acid-enriched meal replacement promotes superior net protein balance in older, overweight adults.","BACKGROUND & AIMS
Older individuals are susceptible to the loss of muscle and accumulation of fat. To address this problem, we have compared protein kinetics following consumption of an essential amino acid (EAA)-enriched meal replacement (EMR) to consumption of a high-protein meal replacement beverage (Bariatric Advantage, BA) using stable isotope methodology.
METHODS
Eight older (67 ± 2), obese (35 ± 2 kg/m 2 ) female and male participants completed two studies using a randomized, crossover design in which they ingested each meal replacement. The isotopic tracers L-[ 2 H 5 ]phenylalanine & L-[ 2 H 2 ]tyrosine were delivered via primed, continuous intravenous infusion throughout a basal period and following consumption of EMR or BA. We determined changes in whole body protein synthesis (PS), protein breakdown (PB), and net protein balance (NB) from fasted states via analysis of plasma samples by LC-ESI-MS.
RESULTS
PS was higher (P = 0.03) and PB was less (P = 0.005) with EMR in comparison to BA. As a result, NB was much greater (P = 0.00003) following the ingestion of EMR as compared to BA.
CONCLUSIONS
In comparison with BA, which has a higher amount of intact protein that any other meal replacement, EMR promoted a greater increment in NB. These data support the potential efficacy of EMR as a meal replacement for the preservation of lean tissue mass during weight loss in older, overweight individuals.",2019,"RESULTS
PS was higher (P = 0.03) and PB was less (P = 0.005) with EMR in comparison to BA.","['Older individuals', 'older, overweight adults', 'Eight older (67\xa0±\xa02), obese (35\xa0±\xa02\xa0kg/m 2 ', 'female and male participants', 'older, overweight individuals']","['Essential amino acid-enriched meal replacement', 'phenylalanine & L-[ 2 H 2 ]tyrosine', 'EMR']","['whole body protein synthesis (PS), protein breakdown (PB), and net protein balance (NB', 'PB', 'NB']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0448123,"RESULTS
PS was higher (P = 0.03) and PB was less (P = 0.005) with EMR in comparison to BA.","[{'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Coker', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA; Essential Blends, LLC, Fairbanks, AK, USA. Electronic address: rcoker@alaska.edu.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Shin', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Scholten', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Johannsen', 'Affiliation': 'Institute of Arctic Biology, University of Alaska Fairbanks, AK, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Tsigonis', 'Affiliation': 'Tanana Valley Clinic, Fairbanks, AK, USA.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular Medicine, Lee Gil Ya Cancer and Diabetes Institute, Gachon University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Schutzler', 'Affiliation': 'Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Essential Blends, LLC, Fairbanks, AK, USA; Department of Geriatrics, Center for Translational Research in Aging & Longevity, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.12.013']
513,29324299,Boys with conduct problems and callous-unemotional traits: Neural response to reward and punishment and associations with treatment response.,"Abnormalities in reward and punishment processing are implicated in the development of conduct problems (CP), particularly among youth with callous-unemotional (CU) traits. However, no studies have examined whether CP children with high versus low CU traits exhibit differences in the neural response to reward and punishment. A clinic-referred sample of CP boys with high versus low CU traits (ages 8-11; n = 37) and healthy controls (HC; n = 27) completed a fMRI task assessing reward and punishment processing. CP boys also completed a randomized control trial examining the effectiveness of an empirically-supported intervention (i.e., Stop-Now-And-Plan; SNAP). Primary analyses examined pre-treatment differences in neural activation to reward and punishment, and exploratory analyses assessed whether these differences predicted treatment outcome. Results demonstrated associations between CP and reduced amygdala activation to punishment independent of age, race, IQ and co-occurring ADHD and internalizing symptoms. CU traits were not associated with reward or punishment processing after accounting for covariates and no differences were found between CP boys with high versus low CU traits. While boys assigned to SNAP showed a greater reduction in CP, differences in neural activation were not associated with treatment response. Findings suggest that reduced sensitivity to punishment is associated with early-onset CP in boys regardless of the level of CU traits.",2018,CU traits were not associated with reward or punishment processing after accounting for covariates and no differences were found between CP boys with high versus low CU traits.,"['CP boys', 'Boys with conduct problems and callous-unemotional traits', 'A clinic-referred sample of CP boys with high versus low CU traits (ages 8-11; n\u202f=\u202f37) and healthy controls (HC; n\u202f=\u202f27) completed a']","['SNAP', 'fMRI task assessing reward and punishment processing']","['CP', 'neural activation', 'CU traits', 'reward or punishment processing', 'neural activation to reward and punishment']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0074709', 'cui_str': 'Snap (resin)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0034119', 'cui_str': 'Punishment'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0034119', 'cui_str': 'Punishment'}]",,0.0355337,CU traits were not associated with reward or punishment processing after accounting for covariates and no differences were found between CP boys with high versus low CU traits.,"[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Byrd', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, United States. Electronic address: alb202@pitt.edu.'}, {'ForeName': 'Samuel W', 'Initials': 'SW', 'LastName': 'Hawes', 'Affiliation': 'Florida International University, Department of Psychology, United States.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Burke', 'Affiliation': 'University of Connecticut, Department of Psychological Sciences, United States.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Loeber', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, United States.'}, {'ForeName': 'Dustin A', 'Initials': 'DA', 'LastName': 'Pardini', 'Affiliation': 'Arizona State University, Department of Criminology, United States.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2017.12.004']
514,31786154,"Upadacitinib in adults with moderate to severe atopic dermatitis: 16-week results from a randomized, placebo-controlled trial.","BACKGROUND
Atopic dermatitis is a chronic inflammatory skin disease characterized by pruritic skin lesions.
OBJECTIVE
We sought to evaluate the safety and efficacy of multiple doses of the selective Janus kinase 1 inhibitor upadacitinib in patients with moderate to severe atopic dermatitis.
METHODS
In the 16-week, double-blind, placebo-controlled, parallel-group, dose-ranging portion of this 88-week trial in 8 countries (ClinicalTrials.gov, NCT02925117; ongoing, not recruiting), adults with moderate to severe disease and inadequate control by topical treatment were randomized 1:1:1:1, using an interactive response system and stratified geographically, to once-daily upadacitinib oral monotherapy 7.5, 15, or 30 mg or placebo. The primary end point was percentage improvement in Eczema Area and Severity Index from baseline at week 16. Efficacy was analyzed by intention-to-treat in all randomized patients. Safety was analyzed in all randomized patients who received study medication, based on actual treatment.
RESULTS
Patients (N = 167) enrolled from November 21, 2016, to April 20, 2017. All were randomized and analyzed for efficacy (each upadacitinib group, n = 42; placebo, n = 41); 166 were analyzed for safety (each upadacitinib group, n = 42; placebo, n = 40). The mean (SE) primary efficacy end point was 39% (6.2%), 62% (6.1%), and 74% (6.1%) for the upadacitinib 7.5-, 15-, and 30-mg groups, respectively, versus 23% (6.4%) for placebo (P = .03, <.001, and <.001). Serious adverse events occurred in 4.8% (2 of 42), 2.4% (1 of 42), and 0% (0 of 42) of upadacitinib groups (vs 2.5% [1 of 40] for placebo).
CONCLUSIONS
A dose-response relationship was observed for upadacitinib efficacy; the 30-mg once-daily dose showed the greatest clinical benefit. Dose-limiting toxicity was not observed.",2020,"Serious adverse events occurred in 4.8% [2/42], 2.4% [1/42], 0% [0/42] of upadacitinib groups (vs 2.5% [1/40] for placebo).
","['patients with moderate-to-severe atopic dermatitis', 'Patients (N=167) enrolled from November 21, 2016, to April 20, 2017', 'adults with moderate-to-severe disease and inadequate control by topical treatment', 'Adults With Moderate-to-Severe Atopic Dermatitis']","['placebo', 'Placebo', 'selective Janus kinase 1 inhibitor upadacitinib']","['mean (standard error) primary efficacy endpoint', 'Efficacy', 'Serious adverse events', 'percentage improvement in Eczema Area and Severity Index']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0169658', 'cui_str': 'Jak1 Kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",166.0,0.619899,"Serious adverse events occurred in 4.8% [2/42], 2.4% [1/42], 0% [0/42] of upadacitinib groups (vs 2.5% [1/40] for placebo).
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: emma.guttman@mountsinai.org.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'Immunology Clinical Development, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'H Chih-Ho', 'Initials': 'HC', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia and Probity Medical Research, Surrey, British Columbia, Canada.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K Papp Clinical Research, Waterloo, Ontario, Canada.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, and Skinflammation Center, Hamburg, Germany.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Jaclyn K', 'Initials': 'JK', 'LastName': 'Anderson', 'Affiliation': 'Immunology Clinical Development, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Data and Statistical Sciences, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Henrique D', 'Initials': 'HD', 'LastName': 'Teixeira', 'Affiliation': 'Immunology Clinical Development, AbbVie Inc, North Chicago, Ill.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.11.025']
515,30959747,Motivating Diabetic and Hypertensive Patients to Engage in Regular Physical Activity: A Multi-Component Intervention Derived from the Concept of Photovoice.,"Aims: A community-based multi-component intervention (increasing awareness of the importance of physical activity in chronic illness management through reading comic books, training regarding warm-up stretching exercises, identifying facilitators and barriers to exercise through photosharing, supporting self-reflection and development of action plans) was developed to promote physical activity (PA) among patients with diabetes and hypertension. This study aimed to evaluate the efficacy of this intervention on health behaviour (walking) and health outcomes. Design: A non-randomized controlled trial with waitlisted control and pre- and post-measures. Setting: Community centres for the elderly. Participants: A total of 204 older adults with diabetes and/or hypertension were recruited. They were assigned to either the intervention group (IG) or waitlisted to the control group (CG). Intervention: Under the supervision of a nurse, six weekly group meetings were arranged in community centres for the elderly in which the participants freely exchanged their views regarding the barriers and facilitators of regular physical activity. Participants were encouraged to take photos in their neighbourhood or at home and brought these photos to share at the group meetings. The photos showed both the barriers and the facilitators to PA. In the last meeting, each participant worked out a plan to perform PA in the coming four weeks. Measures: PA referred to the number of steps taken per day and it was measured by a Garmin Accelerometer at baseline, Week 6 and Week 10. Other measures included the nine-item Self-Efficacy Scale for Exercise⁻Chinese version (SEE-C), and the 23-item Chinese Barriers to Exercise Scale and Senior Fitness Tests. Generalised estimating equations (GEE) models compared the outcomes over time between IG and CG. Results: A statistically significant difference in the changes in the average number of steps taken daily between the two groups at Week 10 (mean difference = 965.4; 95% confidence interval: 92.2, 1838.6, p = 0.030) was observed, although the difference at Week 6 was non-significant (mean difference = 777.6; 95% confidence interval: -35.3, 1590.5, p = 0.061). IG participants also showed significant improvements in lower body strength (mean difference = 0.967; 95% confidence interval: 0.029, 1.904, p = 0.043) and lower limb flexibility (mean difference = 2.068; 95% confidence interval: 0.404, 3.731, p = 0.015) at Week 10 compared to CG participants. Conclusion: This multi-component intervention improved the participants' physical activity level and physical fitness, particularly in lower limb flexibility and body strength.",2019,"IG participants also showed significant improvements in lower body strength (mean difference = 0.967; 95% confidence interval: 0.029, 1.904, p = 0.043) and lower limb flexibility (mean difference = 2.068;","['204 older adults with diabetes and/or hypertension were recruited', 'patients with diabetes and hypertension', 'Motivating Diabetic and Hypertensive Patients to Engage in Regular Physical Activity', 'Participants']","['intervention group (IG) or waitlisted to the control group (CG', 'community-based multi-component intervention']","['health behaviour (walking) and health outcomes', 'lower body strength', 'physical activity level and physical fitness', 'average number of steps taken daily', 'Measures: PA referred to the number of steps taken per day and it was measured by a Garmin Accelerometer', 'lower limb flexibility', 'nine-item Self-Efficacy Scale for Exercise⁻Chinese version (SEE-C), and the 23-item Chinese Barriers to Exercise Scale and Senior Fitness Tests']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0222045'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",204.0,0.0374859,"IG participants also showed significant improvements in lower body strength (mean difference = 0.967; 95% confidence interval: 0.029, 1.904, p = 0.043) and lower limb flexibility (mean difference = 2.068;","[{'ForeName': 'Angela Y M', 'Initials': 'AYM', 'LastName': 'Leung', 'Affiliation': 'Centre for Geronotological Nursing (CGN), School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China. angela.ym.leung@polyu.edu.hk.'}, {'ForeName': 'Pui Hing', 'Initials': 'PH', 'LastName': 'Chau', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong, China. phchau@graduate.hku.hk.'}, {'ForeName': 'Isaac S H', 'Initials': 'ISH', 'LastName': 'Leung', 'Affiliation': 'Centre for Geronotological Nursing (CGN), School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China. isaac.sh.leung@polyu.edu.hk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'Institute of Human Performance, The University of Hong Kong, Hong Kong, China. matse@hku.hk.'}, {'ForeName': 'Perick L C', 'Initials': 'PLC', 'LastName': 'Wong', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Western District Elderly Community Centre, Hong Kong, China. lcwong@skhwc.org.hk.'}, {'ForeName': 'Wai Ming', 'Initials': 'WM', 'LastName': 'Tam', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Western District Elderly Community Centre, Hong Kong, China. wmtam@skhwc.org.hk.'}, {'ForeName': 'Doris Y P', 'Initials': 'DYP', 'LastName': 'Leung', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong, China. doris.yp.leung@polyu.edu.hk.'}]",International journal of environmental research and public health,['10.3390/ijerph16071219']
516,30770892,Delta-9-tetrahydrocannabinol increases striatal glutamate levels in healthy individuals: implications for psychosis.,"The neurobiological mechanisms underlying the association between cannabis use and acute or long-lasting psychosis are not completely understood. While some evidence suggests altered striatal dopamine may underlie the association, direct evidence that cannabis use affects either acute or chronic striatal dopamine is inconclusive. In contrast, pre-clinical research suggests that cannabis may affect dopamine via modulation of glutamate signaling. A double-blind, randomized, placebo-controlled, crossover design was used to investigate whether altered striatal glutamate, as measured using proton magnetic resonance spectroscopy, underlies the acute psychotomimetic effects of intravenously administered delta-9-tetrahydrocannabinol (Δ9-THC; 1.19 mg/2 ml), the key psychoactive ingredient in cannabis, in a set of 16 healthy participants (7 males) with modest previous cannabis exposure. Compared to placebo, acute administration of Δ9-THC significantly increased Glutamate (Glu) + Glutamine (Gln) metabolites (Glx) in the left caudate head (P = 0.027). Furthermore, compared to individuals who were not sensitive to the psychotomimetic effects of Δ9-THC, individuals who developed transient psychotic-like symptoms (~70% of the sample) had significantly lower baseline Glx (placebo; P 7= 0.023) and a 2.27-times higher increase following Δ9-THC administration. Lower baseline Glx values (r = -0.55; P = 0.026) and higher previous cannabis exposure (r = 0.52; P = 0.040) were associated with a higher Δ9-THC-induced Glx increase. These results suggest that an increase in striatal glutamate levels may underlie acute cannabis-induced psychosis while lower baseline levels may be a marker of greater sensitivity to its acute psychotomimetic effects and may have important public health implications.",2020,"Compared to placebo, acute administration of Δ9-THC significantly increased Glutamate (Glu) + Glutamine (Gln) metabolites (Glx) in the left caudate head (P = 0.027).","['healthy individuals', '16 healthy participants (7 males) with modest previous cannabis exposure']","['delta-9-tetrahydrocannabinol', 'Delta-9-tetrahydrocannabinol', 'placebo']","['Glutamate (Glu)\u2009+\u2009Glutamine (Gln) metabolites (Glx', 'striatal glutamate levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220839', 'cui_str': 'Glutamate'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",16.0,0.476786,"Compared to placebo, acute administration of Δ9-THC significantly increased Glutamate (Glu) + Glutamine (Gln) metabolites (Glx) in the left caudate head (P = 0.027).","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colizzi', 'Affiliation': ""National Institute for Health Research (NIHR) Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust, and Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Weltens', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism and Ageing, University of Leuven, Leuven, 3000, Belgium.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""National Institute for Health Research (NIHR) Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust, and Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lythgoe', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK.""}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Laboratory for Brain-Gut Axis Studies (LaBGAS), Translational Research Center for Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism and Ageing, University of Leuven, Leuven, 3000, Belgium.'}, {'ForeName': 'Sagnik', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': ""National Institute for Health Research (NIHR) Biomedical Research Centre (BRC), South London and Maudsley NHS Foundation Trust, and Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, SE5 8AF, UK. sagnik.2.bhattacharyya@kcl.ac.uk.""}]",Molecular psychiatry,['10.1038/s41380-019-0374-8']
517,31970939,"Safety, Tolerability, Pharmacokinetics, and Food Effects on TAC-302 in Healthy Participants: Randomized, Double-Blind, Placebo-Controlled, Single-Dose and Multiple-Dose Studies.","TAC-302 stimulates neurite outgrowth activity and is expected to restore urinary function in patients with lower urinary tract dysfunction. We conducted 2 phase 1, randomized, placebo-controlled studies to confirm the safety and pharmacokinetics (PK) of TAC-302 in healthy adult Japanese male volunteers. In the first-in-human single-dose study (n = 60), TAC-302 was administered at doses from 100 to 1200 mg after an overnight fast. The effects of a meal on the PK of TAC-302 400 mg were also examined. A multiple-dose study (n = 36) evaluated the effects of meal fat content on the PK of single doses of TAC-302 (100, 200, or 400 mg) and multiple doses of TAC-302 administered for 5 days (100, 200, and 400 mg twice daily). TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state. No accumulation of TAC-302 was observed. Food, particularly with high fat content, increased TAC-302 plasma concentrations. No differences were observed in the adverse event incidence between the TAC-302 and placebo groups in either study. TAC-302 showed a wide safety margin.",2020,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","['healthy adult Japanese male volunteers', 'Healthy Participants', 'patients with lower urinary tract dysfunction']","['Placebo', 'placebo', 'TAC-302']","['Safety, Tolerability, Pharmacokinetics, and Food Effects', 'adverse event incidence', 'TAC-302 plasma concentrations', 'safety and pharmacokinetics (PK', 'accumulation of TAC-302']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure (body structure)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0894403,"TAC-302 showed linear PK up to doses of 1200 mg in the fasting state, and across the dose range of 100-400 mg in the fed state.","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Sesoko', 'Affiliation': 'Sosenkai Clinic Edogawa, Mizue, Edogawa-ku, Tokyo, Japan.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Pharmacovigilance Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Takashige', 'Initials': 'T', 'LastName': 'Okayama', 'Affiliation': 'Pharmacokinetics Research Laboratories, Taiho Pharmaceutical Co., Ltd., Okubo, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Nishida', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Miyoshi', 'Affiliation': 'Clinical Development II Department, Taiho Pharmaceutical Co., Ltd., Uchikanda, Chiyoda-ku, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.776']
518,31808376,An eHealth Program for Parents of Adolescents With T1DM Improves Parenting Stress: A Randomized Control Trial.,"PURPOSE
The purpose of this study was to evaluate the short-term effects of the Type 1 Teamwork program for parents of adolescents with type 1 diabetes mellitus (T1DM) on the primary outcome of psychosocial stress.
METHODS
The study was a randomized wait-list control trial evaluating an eHealth program to reduce parenting stress around T1DM management during adolescence through interactive sessions on the safe transfer of responsibility, positive communication, and stress management. The primary outcome was psychosocial stress (parenting stress specific to child illness and general stress). Secondary outcomes included depressive and anxiety symptoms, parent support for adolescent autonomy, family conflict, and adolescent metabolic control (A1C). Data were collected at baseline, 3 months, and 6 months online. Mixed-model analyses were conducted, using intent-to-treat procedures.
RESULTS
Parents (n = 162) had a mean age of 45.6 (±5.3) years, were 98% female, 91% white, 91% married/partnered, 51% of high income, and geographically dispersed around the United States. Parents reported that adolescents had a mean A1C of 7.9% (±1.2%) and T1DM duration of 5.08 (±3.62) years. At 6 months, parents in the Type 1 Teamwork group demonstrated less parenting stress compared with the control group. There were no differences between groups on general stress or secondary outcomes. Attrition at 6 months was 32% in the treatment group and 11% in the control group.
CONCLUSIONS
An eHealth program for parents of adolescents with T1DM improves parenting stress in a sample of parents from across the United States.",2020,An eHealth program for parents of adolescents with T1DM improves parenting stress in a sample of parents from across the United States.,"['Parents of Adolescents', 'parents of adolescents with type 1 diabetes mellitus (T1DM', 'Parenting Stress', 'Parents (n = 162) had a mean age of 45.6 (±5.3) years, were 98% female, 91% white, 91% married/partnered, 51% of high income, and geographically dispersed around the United States', 'parents of adolescents with']","['eHealth program', 'T1DM', 'Type 1 Teamwork program']","['parenting stress', 'depressive and anxiety symptoms, parent support for adolescent autonomy, family conflict, and adolescent metabolic control (A1C', 'psychosocial stress (parenting stress specific to child illness and general stress', 'Attrition']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C4545472', 'cui_str': 'Disperse (transformation)'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0233542', 'cui_str': 'Family conflict (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",162.0,0.0603663,An eHealth program for parents of adolescents with T1DM improves parenting stress in a sample of parents from across the United States.,"[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Whittemore', 'Affiliation': 'Yale School of Nursing, West Haven, Connecticut.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'HealthCore, Inc, Watertown, Massachusetts.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Delvy', 'Affiliation': 'Yale School of Nursing, West Haven, Connecticut.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Zincavage', 'Affiliation': 'HealthCore, Inc, Watertown, Massachusetts.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Ambrosoli', 'Affiliation': 'HealthCore, Inc, Watertown, Massachusetts.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'HealthCore, Inc, Watertown, Massachusetts.'}, {'ForeName': 'Bernet', 'Initials': 'B', 'LastName': 'Kato', 'Affiliation': 'HealthCore, Inc, Watertown, Massachusetts.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Marceau', 'Affiliation': 'HealthCore, Inc, Watertown, Massachusetts.'}]",The Diabetes educator,['10.1177/0145721719890372']
519,31971616,Closure of the fascial defect during laparoscopic umbilical hernia repair: a randomized clinical trial.,"BACKGROUND
The objective of the study was to analyse patient-reported outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain after closure of the fascial defect in patients undergoing laparoscopic umbilical hernia mesh repair.
METHODS
This was a randomized double-blinded trial in patients undergoing elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair. Postoperative pain, movement limitations, discomfort and fatigue were registered before surgery and on postoperative days 1-3, 7 and 30. Seroma formation, quality of life and cosmesis were assessed at day 30, and at 2 years of follow-up. Recurrence (clinical and reoperation) and chronic pain were assessed after 2 years.
RESULTS
Eighty patients were randomized. Median defect sizes in closure and no-closure groups were 2·5 (range 1·5-4·0) and 2·5 (2·0-5·5) cm respectively (P = 0·895). There were no significant differences in early and late postoperative pain or in any other early or late PROMs, except for early fatigue which was higher in the closure group (P = 0·011). Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i. 22 to 51) per cent) compared with no closure (22 of 38; 58 (42 to 72) per cent) (P = 0·043). Cumulative recurrence after 2 years was lower in the closure group: 5 of 36 (7 (3 to 17) per cent) versus 12 of 37 (19 (10 to 33) per cent) for no closure (P = 0·047).
CONCLUSION
Closure of the fascial defect in laparoscopic umbilical hernia IPOM repair significantly reduced early seroma formation and long-term recurrence without inducing side-effects such as pain, or other early or late PROMs. Registration number: NCT01962480 ( https://www.clinicaltrials.gov).",2020,Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i.,"['Eighty patients were randomized', 'patients undergoing', 'patients undergoing laparoscopic umbilical hernia mesh repair']","['laparoscopic umbilical hernia repair', 'elective laparoscopic umbilical hernia repair comparing sutured closure of the fascial defect before intraperitoneal onlay mesh (IPOM) repair with a no-closure IPOM repair']","['early and late postoperative pain', 'Recurrence (clinical and reoperation) and chronic pain', 'early seroma formation and long-term recurrence', 'Postoperative pain, movement limitations, discomfort and fatigue', 'Median defect sizes', 'Cumulative recurrence', 'outcome measures (PROMs), seroma formation, long-term recurrence and chronic pain', 'Seroma formation, quality of life and cosmesis', 'Seroma formation']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306503', 'cui_str': 'Exomphalos'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0019333', 'cui_str': 'Repair of umbilical hernia (procedure)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal (qualifier value)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034380'}]",80.0,0.649892,Seroma formation after 30 days was significantly reduced after closure (14 of 40; 35 (95 per cent c.i.,"[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Christoffersen', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Westen', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Herlev Hospital, University of Copenhagen, Copenhagen.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Helgstrand', 'Affiliation': 'Department of Surgery, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bisgaard', 'Affiliation': 'Gastro Unit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital.'}]",The British journal of surgery,['10.1002/bjs.11490']
520,31944519,Ferulic acid 12% peel: An innovative peel for constitutional type of periorbital melanosis-Comparing clinical efficacy and safety with 20% glycolic peel and 15% lactic peel.,"BACKGROUND
Periorbital hyperpigmentation (POH) is a very common, yet unexplored aesthetic condition. Topical therapy is mainstay of treatment which includes chemical peels and other depigmenting agents.
AIMS
To compare clinical efficacy, safety, and tolerability of 20% glycolic acid peels, 15% lactic acid peels, and 12% ferulic acid peels in the treatment of constitutional type of periorbital hyperpigmentation in Indian patients.
METHODS
Ninety patients of constitutional POH were enrolled for 12 weeks. They were divided into three groups of 30 each. In 1st group 20% glycolic acid peeling, in 2nd group 15% lactic acid peeling and in 3rd group 12% ferulic acid peeling sessions were performed at 3 weekly intervals. Clinical improvement was assessed objectively using POH grading, physician's and patient's global assessment, and patient's global tolerance.
RESULTS
Significant improvement in periorbital hyperpigmentation was noted in all the three groups. Physician and patient's global assessment was excellent with glycolic acid peel followed by ferulic acid peel and lactic acid peel. The incidence of side effects in the form of erythema and itching was maximum with glycolic acid followed by lactic acid and least with ferulic acid, which did not necessitate cessation of therapy.
CONCLUSION
Glycolic acid produced the best results among the three peels; however, ferulic acid peel emerged as a safe and effective modality for the treatment of POH.",2020,Physician and patient's global assessment was excellent with glycolic acid peel followed by ferulic acid peel and lactic acid peel.,"['Periorbital hyperpigmentation (POH', 'Ninety patients of constitutional POH were enrolled for 12 weeks', 'constitutional type of periorbital hyperpigmentation in Indian patients']","['glycolic acid peel followed by ferulic acid peel and lactic acid peel', 'Topical therapy', '20% glycolic peel and 15% lactic peel', 'ferulic acid peeling sessions', '20% glycolic acid peels, 15% lactic acid peels, and 12% ferulic acid peels', 'Ferulic acid 12% peel']","['periorbital hyperpigmentation', ""POH grading, physician's and patient's global assessment, and patient's global tolerance"", 'clinical efficacy, safety, and tolerability']","[{'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}]","[{'cui': 'C1533643', 'cui_str': 'glycolic acid'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0060291', 'cui_str': 'ferulic acid'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441602', 'cui_str': 'Peeling - action (qualifier value)'}]","[{'cui': 'C0230064', 'cui_str': 'Periorbital region structure'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",90.0,0.0290476,Physician and patient's global assessment was excellent with glycolic acid peel followed by ferulic acid peel and lactic acid peel.,"[{'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Dayal', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pt B. D. Sharma, University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Bhavya', 'Initials': 'B', 'LastName': 'Sangal', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pt B. D. Sharma, University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Sahu', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, Pt B. D. Sharma, University of Health Sciences, Rohtak, Haryana, India.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13292']
521,31431077,An Automated Text Message Navigation Program Improves the Show Rate for Outpatient Colonoscopy.,"Background . Numerous barriers to outpatient colonoscopy completion exist, causing undue procedure cancellations and poor bowel preparation. We piloted a text message navigation program to improve colonoscopy adherence. Method. We conducted a prospective study of patients aged 18 to 75 years scheduled for outpatient colonoscopy at an urban endoscopy center in April 2018. An intervention arm consisting of bidirectional, automated text messages prior to the procedure was compared with a usual care arm. We enrolled 21 intervention patients by phone and randomly selected 50 controls. Outcomes included colonoscopy appointment adherence, bowel preparation quality, and colonoscopy completion. Results . The arms had similar demographics and comorbidities. Intervention patients had higher colonoscopy appointment adherence (90% vs. 62%, p = 0.049). There were no significant differences in preparation quality or procedure completeness. Poststudy surveys indicated high patient satisfaction and perceived usefulness of the program. Conclusion . A bidirectional, automated texting navigation program improved colonoscopy adherence rates as compared with usual care.",2019,"Intervention patients had higher colonoscopy appointment adherence (90% vs. 62%, p = 0.049).","['patients aged 18 to 75 years scheduled for outpatient colonoscopy at an urban endoscopy center in April 2018', '21 intervention patients by phone and randomly selected 50 controls']",['text message navigation program'],"['preparation quality or procedure completeness', 'colonoscopy adherence rates', 'colonoscopy appointment adherence, bowel preparation quality, and colonoscopy completion', 'colonoscopy appointment adherence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}]",,0.0389662,"Intervention patients had higher colonoscopy appointment adherence (90% vs. 62%, p = 0.049).","[{'ForeName': 'Nadim', 'Initials': 'N', 'LastName': 'Mahmud', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sahil D', 'Initials': 'SD', 'LastName': 'Doshi', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Coniglio', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Clermont', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Bernard', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Khungar', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119869964']
522,31954026,"Effect of antenatal counselling on early initiation of breastfeeding, an interventional study at two Federal Hospitals, Islamabad Pakistan.","OBJECTIVE
To determine the effect of antenatal counselling at term on early initiation of breastfeeding.
METHODS
The prospective, questionnaire-based study was conducted at two state-run hospitals in Islamabad, Pakistan, from July to December 2016. One hundred subjects at the Federal General Hospital represented intervention group A and received special antenatal counselling regarding benefits of early initiation of breastfeeding, while 100 subjects at the Islamabad Polyclinic formed control group B and received routine counselling. Data was analysed using SPSS Version 20.
RESULTS
Of the 200 subjects initially enrolled, 185 were included in the data analysis , 91 in the intervention group (A) and 94 among the control group (B) and Rest were excluded due to missing data. In group A, 46 (50.5%) women initiated breastfeeding within one hour of childbirth, while in group B 17 (18.08%) women did early inititation (p <0.001).
Conclusion
Counselling was seen to be associated with early initiation of breastfeeding.",2020,"RESULTS
Of the 200 subjects initially enrolled","[' 185 were included in the data analysis , 91 in the intervention group (A) and 94 among the control group (B) and Rest were excluded due to missing data', 'two state-run hospitals in Islamabad, Pakistan, from July to December 2016', 'One hundred subjects at the Federal General Hospital represented intervention group A and received', '200 subjects initially enrolled']","['special antenatal counselling regarding benefits of early initiation of breastfeeding, while 100 subjects at the Islamabad Polyclinic formed control group B and received routine counselling', 'antenatal counselling']",[],"[{'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]","[{'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2317036', 'cui_str': 'Initiation of breastfeeding'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0016589', 'cui_str': 'Forms Control'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]",[],100.0,0.0614755,"RESULTS
Of the 200 subjects initially enrolled","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Federal General Hospital, Islamabad, Pakistan.'}, {'ForeName': 'Humaira', 'Initials': 'H', 'LastName': 'Mehmood', 'Affiliation': 'National University of Medical Sciences, Rawalpindi, Pakistan.'}, {'ForeName': 'Saira', 'Initials': 'S', 'LastName': 'Maroof', 'Affiliation': 'Army Medical College, Rawalpindi, Pakistan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Department of Clinical Research, Tabba Heart Institute, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.302643006']
523,31949084,"No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes.","OBJECTIVE
Dual incretin receptor agonists in clinical development have shown reductions in body weight and hemoglobin A 1c (HbA 1c ) in patients with type 2 diabetes, but the impact of glucose-dependent insulinotropic polypeptide (GIP) receptor activation remains unclear. Here, we evaluated the effects of high-dose exogenous GIP on energy intake, energy expenditure, plasma glucose, and glucose-regulating hormones in patients with type 2 diabetes treated with a long-acting glucagon-like peptide 1 receptor (GLP-1R) agonist.
RESEARCH DESIGN AND METHODS
In a randomized, double-blind design, men with type 2 diabetes ( n = 22, mean ± SEM HbA 1c 6.8 ± 0.1% [51 ± 1.5 mmol/mol]) treated with metformin and long-acting GLP-1R agonists were subjected to two 5-h continuous infusions (separated by a washout period of ≥3 days): one with GIP (6 pmol/kg/min) and another with saline (placebo). After 60 min of infusion, a liquid mixed-meal test was performed, and after 270 min of infusion, an ad libitum meal was served for evaluation of energy intake (primary end point).
RESULTS
Energy intake was similar during GIP and placebo infusion (648 ± 74 kcal vs. 594 ± 55 kcal, respectively; P = 0.480), as were appetite measures and energy expenditure. Plasma glucagon and glucose were higher during GIP infusion compared with placebo infusion ( P = 0.026 and P = 0.017) as assessed by area under the curve.
CONCLUSIONS
In patients with type 2 diabetes, GIP infusion on top of treatment with metformin and a long-acting GLP-1R agonist did not affect energy intake, appetite, or energy expenditure but increased plasma glucose compared with placebo. These results indicate no acute beneficial effects of combining GIP and GLP-1.",2020,"Plasma glucagon and glucose were higher during GIP infusion compared with placebo infusion ( P = 0.026 and P = 0.017) as assessed by area under the curve.
","['Men', 'patients with type 2 diabetes treated with a long-acting glucagon-like peptide 1 receptor (GLP-1R) agonist', 'patients with type 2 diabetes, GIP infusion on top of treatment with', 'patients with type 2 diabetes', 'men with type 2 diabetes ( n = 22, mean ± SEM HbA 1c 6.8 ± 0.1% [51 ± 1.5 mmol/mol]) treated with']","['placebo', 'metformin and long-acting GLP-1R agonists', 'GIP (6 pmol/kg/min) and another with saline (placebo', 'high-dose exogenous GIP', 'Exogenous Glucose-Dependent Insulinotropic Polypeptide', 'metformin']","['energy intake, appetite, or energy expenditure but increased plasma glucose', 'body weight and hemoglobin', 'energy intake, energy expenditure, plasma glucose, and glucose-regulating hormones', 'Plasma glucagon and glucose', 'Energy Intake, Appetite, or Energy Expenditure', 'appetite measures and energy expenditure']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",594.0,0.136426,"Plasma glucagon and glucose were higher during GIP infusion compared with placebo infusion ( P = 0.026 and P = 0.017) as assessed by area under the curve.
","[{'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Sebastian M', 'Initials': 'SM', 'LastName': 'Heimbürger', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Liva S L', 'Initials': 'LSL', 'LastName': 'Krogh', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Dela', 'Affiliation': 'Xlab, Center for Healthy Ageing, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Jessen', 'Affiliation': 'Zealand Pharma A/S, Glostrup, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Asger', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark filip.krag.knop.01@regionh.dk.'}]",Diabetes care,['10.2337/dc19-0578']
524,31925809,Effects of statin therapy and exercise on postprandial triglycerides in overweight individuals with hypercholesterolaemia.,"AIMS
To determine the effects of statins on postprandial lipaemia (PPL) and to study if exercise could enhance statin actions.
METHODS
Ten hypercholesteraemic (blood cholesterol 204 ± 36 mg dL -1 ; low-density lipoprotein-cholesterol 129 ± 32 36 mg dL -1 ) overweight (body mass index 30 ± 4 kg m -2 ), metabolic syndrome individuals chronically medicated with statins (>6 months) underwent 5-hour PPL tests in 4 occasions in a randomized order: (i) substituting their habitual statin medication by placebo for 96 hours (PLAC trial); (ii) taking their habitual statin medicine (STA trial); (iii) placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial); and (iv) combining exercise and statin medicine (EXER+STA trial).
RESULTS
Before the fat meal, statin withdrawal (i.e. PLAC and EXER+PLAC) increased blood triglycerides (TG; 24%), low-density lipoprotein-cholesterol (31%) and total cholesterol (19%; all P < .05) evidencing treatment compliance. After the meal, statin withdrawal increased 5-hour postprandial TG (PPTG) compared to its matched trials (94% higher PLAC vs STA and 45% higher EXER+PLAC vs EXER+STA; P < .05). EXER+PLAC trial did not lower PPTG below PLAC (i.e. incremental AUC of 609 ± 152 vs 826 ± 190 mg dL -1 5 h; P = .09). Adding exercise to statin did not result in larger reductions in PPTG (i.e. EXER+STA vs STA incremental area under the curve of 421 ± 87 vs 421 ± 84 mg dL -1 5 h; P = .99).
CONCLUSION
In hypercholesteraemic metabolic syndrome individuals, chronic statin therapy blunts the elevations in TG after a fat meal (i.e. incremental area under the curve of PPTG) reducing the cardiovascular risk associated to their atherogenic dyslipidaemia. However, a single bout of intense aerobic exercise before the high fat meal, does not reduce PPTG but also does not interfere with the effects of statin treatment.",2020,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[' LDL-c 129±32 36 mg·dL -1 ) overweight (BMI 30±4 kg·m -2 ), metabolic syndrome (MetS) individuals chronically medicated with statins (> 6 months', 'overweight individuals with hypercholesterolemia', 'Ten hypercholesterolemic (blood cholesterol', '204±36']","['habitual statin medication by placebo', 'placebo combined with a bout of intense aerobic exercise (EXER+PLAC trial) and d) combining exercise and statin medicine (EXER+STA trial', 'fat meal', 'EXER+PLAC', 'statins therapy and exercise', 'statins']","['postprandial triglycerides', 'blood triglycerides', 'total cholesterol', 'statin withdrawal increased 5-h postprandial TG (PPTG', 'LDL-c', 'mg·dL -1']","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",10.0,0.111124,"EXER+PLAC trial did not lower PPTG below PLAC (i.e., incremental AUC of 609±152 vs 826±190","[{'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Juan Fernando', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Lab at Toledo, University of Castilla-La Mancha, Spain.'}]",British journal of clinical pharmacology,['10.1111/bcp.14217']
525,31981832,Active video games for knee osteoarthritis improve mobility but not WOMAC score: A randomized controlled trial.,"BACKGROUND
Active video games (AVGs) have become popular and have been investigated for their therapeutic purposes. However, the effect of AVGs on patients with knee osteoarthritis (OA) remains uncertain.
OBJECTIVE
We aimed to compare the effects of AVGs with those of traditional therapeutic exercise on patients with knee OA.
METHOD
This was a prospective single-blind, randomized controlled trial. Participants (n=80) with knee OA were allocated to the AVGs group (n=40) or therapeutic exercise group (n=40). Both groups received treatment 3 times a week for 4 weeks. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and secondary outcome measures were the World Health Organization Quality of Life-Brief Vision, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, physical functional performance (including time for 10-m walking and for ascending and descending stairs), Biodex Stability System, Chronic Pain Grade Questionnaire, and Work Ability Index. The patients were evaluated at baseline, 2 and 4 weeks after treatment, and 1 and 3 months after treatment completion.
RESULTS
Both groups showed significant time effect in the pain subcategory of the WOMAC (P=0.047). However, we found no significant group×time interaction effect between the groups at any follow-up assessments for pain (P=0.066), stiffness (P=0.284), or physical function (P=0.179) for the WOMAC. Among the secondary outcomes, we found significant group×time effects favoring the AVG group in dynamic balance (P=0.020), and physical functional performance including 10-m walking time (P=0.002) and stair ascent time (P=0.005), and the physical domain of health (P=0.032).
CONCLUSIONS
Therapeutic exercises and playing AVGs similarly improved the pain of patients with knee OA; however, playing AVGs improved dynamic balance, physical functional performance, and physical health more than therapeutic exercises did.",2020,Both groups showed significant time effect in the pain subcategory of the WOMAC (p = 0.047).,"['patients with knee OA', 'patients with knee osteoarthritis (OA', 'Participants (n = 80) with knee OA']","['Active video games', 'traditional therapeutic exercise', 'therapeutic exercise']","['physical domain of health', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and secondary outcome measures were the World Health Organization Quality of Life-Brief Vision, Hospital Anxiety and Depression Scale, Multidimensional Fatigue Inventory, physical functional performance (including time for 10-m walking and for ascending and descending stairs), Biodex Stability System, Chronic Pain Grade Questionnaire, and Work Ability Index', 'dynamic balance', 'pain subcategory of the WOMAC', 'physical function', 'physical functional performance including 10-m walking time', 'time interaction effect', 'dynamic balance, physical functional performance, and physical health', 'WOMAC score', 'stair ascent time', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0034380'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0205386', 'cui_str': 'Descending (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",80.0,0.0681344,Both groups showed significant time effect in the pain subcategory of the WOMAC (p = 0.047).,"[{'ForeName': 'Yu-Ting', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wen-Chung', 'Initials': 'WC', 'LastName': 'Lee', 'Affiliation': 'Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Ru-Lan', 'Initials': 'RL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan; Department of Physical Medicine and Rehabilitation, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: M001052@ms.skh.org.tw.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2019.11.008']
526,31962317,Differences in the Natural Enamel Surface and Acquired Enamel Pellicle following Exposure to Citric or Hydrochloric Acid.,"OBJECTIVES
The aim of this study was to investigate variations in the interaction between enamel, that is, the acquired enamel pellicle (AEP) and citric or hydrochloric acid.
MATERIALS AND METHODS
A 24-h AEP was formed on natural enamel specimens (n = 40) from pooled whole mouth human saliva. Samples were randomly allocated to citric (0.3%, pH 3.2) or hydrochloric (HCl) acid (0.01 M, pH 2.38) exposure for 30 or 300 s. The total protein concentration (TPC), and phosphorous and calcium concentrations of the pellicle were determined before and after acid exposure, and again after re-immersion in saliva. Surface roughness and tandem scanning confocal microscopy imaging were used to assess enamel changes.
RESULTS
After 300 s of citric acid exposure, the mean ± SD TPC reduced from 5.1 ± 1.1 to 3.5 ± 1.1 mg/mL (p < 0.05). In contrast, after 300 s of HCl exposure, the mean TPC did not reduce significantly from baseline (6.6 ± 1.1 to 5.7 ± 0.7 mg/mL) but was significantly reduced in the reformed pellicle to 4.9 ± 1.2 mg/mL (p < 0.001). This reduction occurred after significant release of calcium and phosphorous from the enamel surface (p < 0.001). Thirty seconds of exposure to either acid had no obvious effect on the AEP. The surface roughness of the enamel decreased after acid exposure but no differences between groups was observed.
CONCLUSIONS
These findings indicate that citric acid interacted with proteins in the AEP upon contact, offering enamel protection. In contrast, HCl appeared to bypass the pellicle, and reduced protein was observed only after changes in the enamel chemical composition.",2020,This reduction occurred after significant release of calcium and phosphorous from the enamel surface (p < 0.001).,[],"['Citric or Hydrochloric Acid', 'citric acid', 'hydrochloric (HCl) acid']","['AEP', 'mean TPC', 'mean ± SD TPC', 'total protein concentration (TPC), and phosphorous and calcium concentrations of the pellicle', 'surface roughness of the enamel']",[],"[{'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0011350', 'cui_str': 'Enamel'}]",,0.0300405,This reduction occurred after significant release of calcium and phosphorous from the enamel surface (p < 0.001).,"[{'ForeName': 'Jack William', 'Initials': 'JW', 'LastName': 'Houghton', 'Affiliation': ""Centre for Host Microbe-Interactions, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom, jack.houghton@kcl.ac.uk.""}, {'ForeName': 'Jing Teng', 'Initials': 'JT', 'LastName': 'Yong', 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Carpenter', 'Affiliation': ""Centre for Host Microbe-Interactions, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Moazzez', 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}, {'ForeName': 'Saoirse', 'Initials': 'S', 'LastName': ""O'Toole"", 'Affiliation': ""Centre for Clinical, Oral and Translational Sciences, King's College London Faculty of Dental, Oral and Craniofacial Sciences, London, United Kingdom.""}]",Caries research,['10.1159/000504746']
527,31960624,"A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men.","Tezepelumab, a human immunoglobulin G2 monoclonal antibody against thymic stromal lymphopoietin, is currently under clinical development for the treatment of severe, uncontrolled asthma. This phase 1, randomized, placebo-controlled, single-ascending-dose study assessed the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous tezepelumab in healthy Japanese men. Participants were assigned to 1 of 3 tezepelumab dose cohorts (35, 105, or 280 mg; n = 8 per cohort) and randomized (6:2) to receive a single subcutaneous dose of tezepelumab or placebo, with a follow-up period of 84 to 112 days. The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups. Tezepelumab was absorbed slowly, reaching a maximum serum concentration (mean, 5.2-39.7 µg/mL) after 7 to 10 days. Area under the concentration-time curve (mean, 207.2-1612.0 µg · day /mL) increased in an approximate dose-proportional manner. Tezepelumab had a long terminal serum half-life (mean, 23.9-26.3 days) and a small apparent distribution volume, suggesting limited distribution into peripheral tissues. No participants developed anti-tezepelumab antibodies. Single-dose, subcutaneous administration of tezepelumab 35 to 280 mg resulted in an acceptable safety profile with linear pharmacokinetics in healthy Japanese men. No clear differences in tezepelumab safety and pharmacokinetics between Japanese and non-Japanese populations were identified.",2020,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"['healthy Japanese men', 'Healthy Japanese Men']","['Placebo', 'Tezepelumab', 'tezepelumab', 'tezepelumab or placebo', 'placebo', 'Subcutaneous Tezepelumab', 'subcutaneous tezepelumab']","['overall incidences and severities of treatment-emergent adverse events', 'anti-tezepelumab antibodies', 'tezepelumab safety and pharmacokinetics', 'Safety, Tolerability, Pharmacokinetics, and Immunogenicity', 'maximum serum concentration', 'concentration-time curve', 'safety, tolerability, pharmacokinetics, and immunogenicity']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4550163', 'cui_str': 'tezepelumab'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.196404,The overall incidences and severities of treatment-emergent adverse events were similar across tezepelumab doses and between the tezepelumab and placebo groups.,"[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Matsuki', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Irie', 'Affiliation': 'SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Department of Pharmacology, Division of Clinical Pharmacology, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Horiuchi', 'Affiliation': 'AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Quantitative Clinical Pharmacology, AstraZeneca, Gaithersburg, Maryland, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.775']
528,31967736,"Alveolar ridge preservation with a collagen cone: Histological, histochemical, and immunohistochemical results of a randomized controlled clinical trial.","OBJECTIVES
The objective of the present study was to examine the influence of a combination material of a collagen cone and a collagen membrane on the healing process of extraction sockets with regard to histological, histochemical, and immunohistochemical parameters.
MATERIALS AND METHODS
In a prospective randomized clinical study, 10 patients (test group) received a collagen combination material after tooth removal. The extraction sockets of 10 other patients (control group) were left to heal without further intervention. Eleven ±1 weeks after tooth extraction, histological biopsies were performed in both groups at the time of implant placement. Subsequently, the biopsies were evaluated semiquantitatively in terms of histological, histochemical, and immunohistochemical parameters for the identification of factors of bone metabolism and vascularization.
RESULTS
No significant difference between test and control group were found for any parameter. According to the descriptive data, the use of a collagen combination material seems to result in slightly higher values of the osteogenic Runt-related transcription factor 2 (Runx2) and vascularization.
CONCLUSION
The histological, histochemical, and immunohistochemical analysis of ARP with a collagen cone combined with a collagen membrane showed no significant differences in terms of bone metabolism and vascularization.",2020,No significant difference between test and control group were found for any parameter.,['10 patients (test group) received a'],['collagen combination material after tooth removal'],['bone metabolism and vascularization'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}]",10.0,0.0459937,No significant difference between test and control group were found for any parameter.,"[{'ForeName': 'Sigmar', 'Initials': 'S', 'LastName': 'Schnutenhaus', 'Affiliation': 'Center of Dentistry Dr. Schnutenhaus MVZ GmbH, Hilzingen, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Edelmann', 'Affiliation': 'Department of Prosthetic Dentistry, Center of Dentistry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Dreyhaupt', 'Affiliation': 'Institute of Epidemiology and Medical Biometry, Ulm University, Ulm, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Rudolph', 'Affiliation': 'Center of Dentistry Dr. Schnutenhaus MVZ GmbH, Hilzingen, Germany.'}, {'ForeName': 'Ralph G', 'Initials': 'RG', 'LastName': 'Luthardt', 'Affiliation': 'Center of Dentistry Dr. Schnutenhaus MVZ GmbH, Hilzingen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Goetz', 'Affiliation': 'Department of Orthodontics, Oral Biology Laboratory, University of Bonn, Bonn, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.279']
529,31925917,"Randomized controlled trial comparing long-pulsed 1064-Nm neodymium: Yttrium-aluminum-garnet laser alone, topical amorolfine nail lacquer alone, and a combination for nondermatophyte onychomycosis treatment.","BACKGROUND
Studies of the laser treatment of nondermatophyte mold (NDM) onychomycosis are limited. Long-pulsed neodymium:yttrium-aluminum-garnet (Nd:YAG) 1064-nm laser has been introduced as an adjuvant dermatophyte onychomycosis treatment.
AIMS
To investigate the efficacy and safety of long-pulsed Nd:YAG 1064-nm laser for NDM onychomycosis treatment, compared with topical amorolfine nail lacquer alone and a combination treatment.
PATIENTS/METHODS
This randomized controlled trial was conducted at the Nail Clinic, Siriraj Hospital. Patients diagnosed with NDM were included and randomly assigned to three treatment groups: laser at 1 month interval (1064-nm Nd:YAG at a fluence of 35 J/cm 2 , pulse width 30 ms, and pulse rate 1.0 Hz); topical amorolfine nail lacquer alone; and a combination treatment.
RESULTS
Sixty patients completed the study. The patients treated with the laser, amorolfine, and the combination achieved mycological cure rates of 35%, 60%, and 65%, respectively (P = .05), while 10%, 30%, and 30% of the patients in the respective groups were clinically cured. The mean durations to the mycological cures in the patients treated with laser, amorolfine, and the combination were 5.9, 4.8, and 5.2 months, respectively. By comparison, the corresponding mean durations to the clinical cures were 6.9, 6.5, and 5.9 months. Both the times to the mycological cures and the clinical cures did not differ significantly between the groups (P = .290 and P = .309, respectively). There were no serious complications with the laser treatment.
CONCLUSIONS
Laser alone achieved only a 30% mycological cure rate for NDM onychomycosis. The combination treatment yielded similar outcomes to the topical treatment alone.",2020,"Both the times to the mycological cures and the clinical cures did not differ significantly between the groups (P = .290 and P = .309, respectively).","['Patients diagnosed with NDM', 'Nail Clinic, Siriraj Hospital', 'Sixty patients completed the study']","['Long-pulsed neodymium:yttrium-aluminum-garnet', 'topical amorolfine nail lacquer alone', 'long-pulsed Nd:YAG 1064-nm laser', 'pulsed 1064-Nm neodymium: Yttrium-aluminum-garnet laser alone, topical amorolfine nail lacquer alone', 'Laser alone', 'laser at 1\xa0month interval ']","['efficacy and safety', 'mean durations to the clinical cures', 'clinical cures', 'mycological cure rate', 'serious complications', 'mycological cure rates', 'mean durations to the mycological cures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0051736', 'cui_str': 'Amorolfine'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0022902', 'cui_str': 'Lacquer'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205467', 'cui_str': 'Mycologic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",60.0,0.0324108,"Both the times to the mycological cures and the clinical cures did not differ significantly between the groups (P = .290 and P = .309, respectively).","[{'ForeName': 'Sumanas', 'Initials': 'S', 'LastName': 'Bunyaratavej', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Ungaksornpairote', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Waritch', 'Initials': 'W', 'LastName': 'Kobwanthanakun', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pattriya', 'Initials': 'P', 'LastName': 'Chanyachailert', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ya-Nin', 'Initials': 'YN', 'LastName': 'Nokdhes', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Poramin', 'Initials': 'P', 'LastName': 'Patthamalai', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ploypailin', 'Initials': 'P', 'LastName': 'Tantrapornpong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Panittra', 'Initials': 'P', 'LastName': 'Suphatsathienkul', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Kiratiwongwan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pichaya', 'Initials': 'P', 'LastName': 'Limphoka', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Charussri', 'Initials': 'C', 'LastName': 'Leeyaphan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13291']
530,31888939,Improving chronic pain management with eHealth and mHealth: study protocol for a randomised controlled trial.,"INTRODUCTION
Chronic pain has become a matter of public health concern due to its high prevalence and because public costs associated with treatment and disability increase each year. Research suggests that limitations in the traditional assessment of chronic pain patients limit the effectiveness of current medical treatments. The use of technology might serve change patient traditional monitoring into ecological momentary assessments, which might be visualised by physicians live. This study describes a randomised control trial designed to test the utility of a technology-based solution for pain telemonitoring consisting of a smartphone app for patients and a web application for physicians. The goal of this study will be to explore whether this combination of eHealth and mHealth improves the effectiveness of existing pain treatments.
METHODS AND ANALYSIS
Participants will be 250 patients randomly assigned to one of these two conditions: treatment-as-usual (TAU) and TAU +app+ web. All participants will receive the usual treatment for their pain. Only the TAU +app+ web group use Pain Monitor app, which generates alarms that are sent to the physicians in the face of previously established undesired events. Physicians will be able to monitor app reports using a web application, which might result in an adjustment of treatment. We anticipate that the use of Pain Monitor plus the therapist web will result in a reduction of pain intensity and side effects of the medication. Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected. Mixed repeated-measure multivariate analyses of variances will be conducted to investigate whether there are differences between preassessment and postassessment scores as a function of the experimental condition.
ETHICS AND DISSEMINATION
Ethical approval from the Hospital General Universitari de Castellon was obtained. The findings will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT03606265.",2019,"Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected.","['Participants will be 250 patients randomly assigned to one of these two conditions', 'pain telemonitoring consisting of a smartphone app for patients and a web application for physicians', 'chronic pain patients']","['treatment-as-usual (TAU) and TAU +app+\u2009web', 'technology-based solution']","['secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}]",250.0,0.136502,"Improvements on secondary outcomes, namely fatigue, mood, pain interference, rescue medication use and quality of life, are also expected.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jaén', 'Affiliation': 'Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castello de la Plana, Spain ijaen@uji.es.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Suso-Ribera', 'Affiliation': 'Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castello de la Plana, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Psychology and Sociology, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Zaragoza', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERobn, CB06/03, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'Basic Psychology, Clinical Psychology and Psychobiology, Universitat Jaume I, Castello de la Plana, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Gómez Palones', 'Affiliation': 'Pain Clinic, Hospital General de Castellon, Castellon de la Plana, Spain.'}]",BMJ open,['10.1136/bmjopen-2019-033586']
531,31888941,Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study.,"INTRODUCTION
Many young adult female (YA-F) cancer survivors who received gonadotoxic therapy will experience fertility problems. After cancer, having a child will often require assisted reproductive technology (ART), surrogacy or adoption. However, there are significant informational, psychosocial, financial and logistical barriers to pursuing these options. Survivors report high rates of decision uncertainty and distress related to family-building decisions. The aim of this study is to pilot test a web-based decision aid and planning tool for family-building after cancer.
METHODS AND ANALYSIS
The pilot study will use a single-arm trial design to test the feasibility and acceptability (aim 1) and obtain effect size estimates of the decision support intervention (aim 2). The target sample size is 100. Participants will include YA-F survivors (aged 18-45 years) who are post-treatment and have not completed desired family-building. A longitudinal prepost design will be conducted. Participants will complete three psychosocial assessment surveys over a 3-month time period to track decisional conflict (primary outcome) and cognitive, emotional, and behavioural functioning (secondary outcomes). After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website. Postintervention surveys will be administered at 1-month (T2) and 3-month (T3) follow-up time points. Feasibility and acceptability metrics will be analysed. Pairwise t-tests will test mean scores of outcome variables from T1 to T2. Effect size estimates (Cohen's d) will be calculated. Google analytics will evaluate user engagement with the website over the study period. Baseline and follow-up data will examine measures of feasibility, acceptability and intervention effect size.
ETHICS AND DISSEMINATION
This will be the first test of a supportive intervention to guide YA-F cancer survivors in family-building decisions and early planning. Study findings will inform intervention development. Future directions will include a randomised controlled trial to test intervention efficacy over a longer time period.
TRIAL REGISTRATION NUMBER
NCT04059237; Pre-results.",2019,"After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website.","['Participants will include YA-F survivors (aged 18-45 years) who are post-treatment and have not completed desired family-building', 'family-building after cancer', 'young adult women after cancer treatment', 'young adult female (YA-F) cancer survivors']","['supportive intervention', 'gonadotoxic therapy']","['Feasibility and acceptability metrics', 'track decisional conflict (primary outcome) and cognitive, emotional, and behavioural functioning (secondary outcomes']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444661', 'cui_str': 'Not completed'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.122292,"After completing the baseline survey (T1; pre-intervention), participants will have access to the decision aid website.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA cbenedict@stanford.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ford', 'Affiliation': 'Hunter College and The Graduate Center, City University of New York (CUNY), New York City, New York, USA.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Schapira', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Simon', 'Affiliation': ""Lucile Packard Children's Hospital Stanford, Palo Alto, California, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Spiegel', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Diefenbach', 'Affiliation': 'Center for Health Innovation and Outcomes Research, Feinstein Institute for Medical Research, Northwell Health, Manhasset, New York, USA.'}]",BMJ open,['10.1136/bmjopen-2019-033630']
532,31787389,Accuracy of wrist-worn heart rate monitors for rate control assessment in atrial fibrillation.,"BACKGROUND
Wrist-worn heart rate (HR) monitors are increasingly popular. A paucity of data exists on their accuracy in atrial fibrillation (AF) in ambulatory patients. We sought to assess the HR accuracy of two commercially available smart watches [SW] (Fitbit Charge HR [FB] and Apple Watch Series 3 [AW]) compared with Holter monitoring in an ambulant patient cohort.
METHODS
Thirty-two participants ≥18 years referred for 24-hour Holter monitoring were prospectively recruited. Each participant was randomly allocated to wear either a FB or AW along with their Holter monitor.
RESULTS
Across all devices, 53,288 heart rate values were analysed from 32 participants. Twenty wore the AW (17 had persistent AF and 3 had sinus rhythm [SR]) while 12 participants wore the FB (9 in persistent AF and 3 in SR). Participants in SR demonstrated strong agreement compared to Holter monitoring (bias <1 beat, limits of agreement [LoA] -11 to 11 beats). In AF, both devices underestimated HR measurements (bias -9 beats, LoA -41 to 23). The degree of underestimation was more pronounced when HR > 100 bpm (bias of -28 beats for HR range 100-120 bpm, -48 for 120-140 bpm, and -69 for >140 bpm) compared to a slower HR (bias of -6 for HR range 80-100 bpm, <1 for 60-80 bpm, and -1 for <60 bpm).
CONCLUSION
In ambulatory patients, smartwatches underestimated HR in AF particularly at HR ranges >100 bpm. Further improvements in device technology are needed before integrating them into the clinical management of rate control in AF.",2020,"Participants in SR demonstrated strong agreement compared to Holter monitoring (bias <1 beat, limits of agreement [LoA] -11 to 11 beats).","['atrial fibrillation', '≥18\u202fyears referred for 24-hour Holter monitoring were prospectively recruited', 'Thirty-two participants', 'ambulant patient cohort', 'ambulatory patients']","['wrist-worn heart rate monitors', 'FB or AW along with their Holter monitor', 'commercially available smart watches [SW] (Fitbit Charge HR [FB] and Apple Watch Series 3 [AW']","['sinus rhythm [SR', 'HR accuracy']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0182920', 'cui_str': 'Electrocardiographic monitor and recorder, device (physical object)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}]","[{'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}]",32.0,0.0287112,"Participants in SR demonstrated strong agreement compared to Holter monitoring (bias <1 beat, limits of agreement [LoA] -11 to 11 beats).","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Al-Kaisey', 'Affiliation': 'Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Anoop N', 'Initials': 'AN', 'LastName': 'Koshy', 'Affiliation': 'Department of Cardiology, Eastern Health, Boxhill, Victoria, Australia; University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Ha', 'Affiliation': 'Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Spencer', 'Affiliation': 'Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Toner', 'Affiliation': 'Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Jithin K', 'Initials': 'JK', 'LastName': 'Sajeev', 'Affiliation': 'Department of Cardiology, Eastern Health, Boxhill, Victoria, Australia.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Teh', 'Affiliation': 'Department of Cardiology, Eastern Health, Boxhill, Victoria, Australia; Eastern Health Clinical School, Monash University, Victoria, Australia.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Farouque', 'Affiliation': 'Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia; University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Han S', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, Austin Health, Heidelberg, Victoria, Australia; University of Melbourne, Melbourne, Australia. Electronic address: lim.h@unimelb.edu.au.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.11.120']
533,31794152,"Comparison of zinc acetate hydrate and polaprezinc for zinc deficiency in patients on maintenance hemodialysis: A single-center, open-label, prospective randomized study.","The efficacy and safety of zinc acetate hydrate (ZAH) for zinc supplementation in patients on maintenance hemodialysis (MHD) remains unknown. In this prospective, single-center, open-label, parallel-group trial for MHD patients with serum zinc level <70 μg/dL, we compared ZAH (zinc; 50 mg/day) and polaprezinc (PPZ; zinc; 34 mg/day) beyond 6-month administration in a 1:1 randomization manner. The ZAH and PPZ groups had 44 and 47 patients, respectively. At 3 months, the change rate of serum zinc levels in the ZAH group was significantly higher than that in the PPZ group. Three months after the study, serum copper levels significantly decreased in the ZAH group, but not in the PPZ group. No significant differences were noted in anemia management in either group. ZAH was superior to PPZ in increasing serum zinc levels. Clinicians should note the stronger decline in serum copper levels when using ZAH for MHD patients.",2020,"Three months after the study, serum copper levels significantly decreased in the ZAH group, and not in the PPZ group.","['MHD patients with serum zinc level <70 μg/dL, we compared', 'patients on maintenance hemodialysis (MHD', 'patients on maintenance hemodialysis']","['zinc supplementation', 'ZAH', 'PPZ', 'zinc acetate hydrate (ZAH', 'zinc acetate hydrate and polaprezinc', 'ZAH (zinc; 50 mg/day) and polaprezinc (PPZ; zinc']","['serum zinc levels', 'serum copper levels', 'anemia management', 'change rate of serum zinc levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0149368', 'cui_str': 'Zinc Acetate'}, {'cui': 'C0286382', 'cui_str': 'zinc carnosine'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}, {'cui': 'C0858105', 'cui_str': 'Serum copper'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.0283921,"Three months after the study, serum copper levels significantly decreased in the ZAH group, and not in the PPZ group.","[{'ForeName': 'Teppei', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Department of Urology, Oyokyo Kidney Research Institute Aomori Hospital, Aomori, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Hatakeyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Konishi', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Okita', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}, {'ForeName': 'Yoshimi', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Urology, Oyokyo Kidney Research Institute Aomori Hospital, Aomori, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Imanishi', 'Affiliation': 'Department of Urology, Oyokyo Kidney Research Institute Aomori Hospital, Aomori, Japan.'}, {'ForeName': 'Tooru', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Department of Urology, Oyokyo Kidney Research Institute Aomori Hospital, Aomori, Japan.'}, {'ForeName': 'Fumitada', 'Initials': 'F', 'LastName': 'Saitoh', 'Affiliation': 'Department of Urology, Oyokyo Kidney Research Institute Aomori Hospital, Aomori, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Oyokyo Kidney Research Institute, Hirosaki, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Ohyama', 'Affiliation': 'Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13461']
534,31595704,"Open-Label, Randomized, Single-Dose, 2-Period, 2-Sequence Crossover, Comparative Pharmacokinetic Study to Evaluate Bioequivalence of 2 Oral Formulations of Olanzapine Under Fasting and Fed Conditions.","Olanzapine, a second-generation atypical antipsychotic drug, is widely used for schizophrenia and moderate to severe mania associated with bipolar disorders. This open-label, randomized, single-dose, 2-sequence, 2-period crossover, comparative pharmacokinetic study assessed the bioequivalence of 5 mg of olanzapine administered in tablet (R) or disintegrating tablet (T) formulation in healthy Chinese volunteers under both fasting and fed conditions. Numbers of enrolled subjects were 30 and 24 for fasting and fed treatments, respectively. Blood samples were drawn and collected predose as well as up to 144 hours postdose. The plasma concentration of olanzapine was quantitated by a robust, rapid, and sensitive liquid chromatography-tandem mass spectrometry method. The R was bioequivalent to T formulation under either fasting or fed conditions. The 90%CI for ratios of the geometric means observed maximum plasma concentration, area under the curve from time 0 extrapolated to last time point, and area under the curve from time 0 extrapolated to infinity were all within the allowed limit (80.0% to 125.0%). The pharmacokinetic profiles of T and R formulations were similar under fasting and fed conditions. Both formulations were well tolerated, with a similar incidence of treatment-emergent adverse events under fasting and fed conditions.",2020,"Both formulations were well tolerated, with a similar incidence of treatment-emergent adverse events under fasting and fed conditions.",['healthy Chinese volunteers under both fasting and fed conditions'],"['Olanzapine', 'olanzapine administered in tablet (R) or disintegrating tablet (T) formulation']",['plasma concentration of olanzapine'],"[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]",,0.0149459,"Both formulations were well tolerated, with a similar incidence of treatment-emergent adverse events under fasting and fed conditions.","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Hongchuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Zhixia', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Weiyue', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Chao-Yang Hospital, Capital Medical University, Chaoyang District, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.743']
535,31917731,RETINAL LEAKAGE INDEX DYNAMICS ON ULTRA-WIDEFIELD FLUORESCEIN ANGIOGRAPHY IN EYES TREATED WITH INTRAVITREAL AFLIBERCEPT FOR PROLIFERATIVE DIABETIC RETINOPATHY IN THE RECOVERY STUDY.,"PURPOSE
Characterization of leakage indices on ultra-widefield fluorescein angiography in proliferative diabetic retinopathy treated with intravitreal aflibercept.
METHODS
Prospective study enrolling subjects for treatment of proliferative diabetic retinopathy randomized 1:1 to receive 2-mg intravitreal aflibercept every 4 weeks (2q4) or every 12 weeks (2q12). Ultra-widefield fluorescein angiography images obtained at baseline, 24, and 48 weeks were analyzed using a semiautomated leakage segmentation platform. Panretinal and zonal leakage indices were calculated.
RESULTS
Forty eyes of 40 subjects were included, and mean age was 48 ± 12.1 years. Mean number of injections was 11 ± 1.7 in the 2q4 arm and 4 ± 0.4 in the 2q12 arm. Median baseline leakage index in the 2q4 and 2q12 groups was 5.1% and 4.3%, respectively (P = 0.28). At 24 and 48 weeks, the 2q4 group significantly improved to 1.1% (-79%, P < 0.0001). At Week 24, the 2q12 group demonstrated nonsignificant improvement (3.4%; -21%, P = 0.47); by Week 48, improvement was significant (1.4%; -68%, P = 0.02). The 2q4 group resulted in lower leakage index compared with the 2q12 group at 24 weeks (1.1% vs. 3.4%, respectively; P = 0.008), but by 48 weeks, leakage index was similar between both groups (1.1% vs. 1.4%, respectively; P = 0.34).
CONCLUSION
Proliferative diabetic retinopathy treated with intravitreal aflibercept demonstrated significant leakage index reductions at 1 year. Monthly dosing provided more rapid reduction in leakage index compared with quarterly dosing.
TRIAL REGISTRATION
RECOVERY study (NCT02863354); https://clinicaltrials.gov/ct2/show/NCT02863354.",2020,"At Week 24, the 2q12 group demonstrated nonsignificant improvement (3.4%; -21%, P = 0.47); by Week 48, improvement was significant (1.4%; -68%, P = 0.02).","['Prospective study enrolling subjects for treatment of proliferative diabetic retinopathy', 'proliferative diabetic retinopathy treated with intravitreal aflibercept', 'Forty eyes of 40 subjects were included, and mean age was 48 ± 12.1 years']","['intravitreal aflibercept', 'ultra-widefield fluorescein angiography', '2-mg intravitreal aflibercept']","['lower leakage index', 'leakage index reductions', 'leakage index', 'Panretinal and zonal leakage indices', 'Median baseline leakage index', 'Mean number of injections']","[{'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0016313', 'cui_str': 'Fluorescein Angiography'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0442132', 'cui_str': 'Panretinal (qualifier value)'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",40.0,0.0459298,"At Week 24, the 2q12 group demonstrated nonsignificant improvement (3.4%; -21%, P = 0.47); by Week 48, improvement was significant (1.4%; -68%, P = 0.02).","[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Babiuch', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Talcott', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Hach', 'Affiliation': 'The Tony and Leona Campane Center for Excellence for Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'The Tony and Leona Campane Center for Excellence for Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Reese', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002727']
536,31833184,Pharmacokinetics and Safety of a Single Oral Dose of Peficitinib (ASP015K) in Japanese Subjects With Normal and Impaired Hepatic Function.,"Peficitinib (ASP015K) is a novel Janus kinase inhibitor developed for the treatment of rheumatoid arthritis (RA). The impact of hepatic impairment on the peficitinib pharmacokinetic (PK) and safety profile was investigated in non-RA subjects (n = 24) in an open-label, parallel-group, multicenter comparative study in Japan. Subjects received a single, clinically relevant, oral dose of a peficitinib 150 mg tablet under fasting conditions. Plasma PK parameters were measured for peficitinib and its metabolites H1 (sulfate and methylated metabolite), H2 (sulfate metabolite), and H4 (methylated metabolite) in subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment. The peficitinib area under the plasma-concentration-time curve from time 0 to infinity (AUC inf ) and maximum observed concentration (C max ) were not markedly different in subjects with mild hepatic impairment versus normal hepatic function. In subjects with moderate hepatic impairment versus normal hepatic function, the geometric mean ratios for peficitinib AUC inf and C max , were 1.92 (90% CI: 1.39, 2.66) and 1.82 (90% CI: 1.24, 2.69), respectively. Five treatment-emergent adverse events (TEAEs) were experienced by 3 subjects, 1 in each group. There were no deaths, no serious TEAEs, and no TEAEs leading to withdrawal. In summary, the PK profile was unaltered in subjects with mild hepatic impairment after a single clinically relevant dose of peficitinib, but exposure almost doubled in subjects with moderate hepatic impairment. Peficitinib dose reduction may be considered in RA patients with moderate hepatic impairment.",2020,"There were no deaths, no serious TEAEs, and no TEAEs leading to withdrawal.","['Japanese Subjects With Normal and Impaired Hepatic Function', 'non-RA subjects (n\xa0=\xa024) in an open-label, parallel-group, multicenter comparative study in Japan', 'subjects with normal hepatic function, mild hepatic impairment, or moderate hepatic impairment', 'RA patients with moderate hepatic impairment']","['Peficitinib (ASP015K', 'Single Oral Dose of Peficitinib (ASP015K', 'peficitinib 150 mg tablet under fasting conditions']","['peficitinib and its metabolites H1 (sulfate and methylated metabolite), H2 (sulfate metabolite), and H4 (methylated metabolite', 'peficitinib pharmacokinetic (PK) and safety profile', 'geometric mean ratios for peficitinib AUC inf and C max', 'PK profile', 'Pharmacokinetics and Safety', 'Plasma PK parameters']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009491', 'cui_str': 'Comparative Study'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4505522', 'cui_str': '4-(((1R,2s,3S,5s,7s)-5-Hydroxyadamantan-2-yl)amino)-1H-pyrrolo(2,3-b)pyridine-5-carboxamide'}, {'cui': 'C4505523', 'cui_str': 'ASP015K'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4505522', 'cui_str': '4-(((1R,2s,3S,5s,7s)-5-Hydroxyadamantan-2-yl)amino)-1H-pyrrolo(2,3-b)pyridine-5-carboxamide'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0322615,"There were no deaths, no serious TEAEs, and no TEAEs leading to withdrawal.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Miyatake', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Shibata', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Oda', 'Affiliation': 'Astellas Research Institute of America LLC, Northbrook, Illinois, USA.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Katashima', 'Affiliation': 'Astellas Pharma Inc, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Sakaki', 'Affiliation': 'Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Inoue', 'Affiliation': 'Showa University Fujigaoka Hospital, Yokohama, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Showa University Koto Toyosu Hospital, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': 'Clinical Research Institute of Clinical Pharmacology and Therapeutics, Showa University, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Furihata', 'Affiliation': 'P-One Clinic, Keikokai Medical Corporation, Tokyo, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Urae', 'Affiliation': 'Mediscience Planning, Inc, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.751']
537,31578781,Does Listening to Music Regulate Negative Affect in a Stressful Situation? Examining the Effects of Self-Selected and Researcher-Selected Music Using Both Silent and Active Controls.,"BACKGROUND
Stress and anxiety are increasingly common among young people. The current research describes two studies comparing the effects of self-selected and researcher-selected music on induced negative affect (state anxiety and physiological arousal), and state mindfulness.
METHOD
In Study 1, 70 undergraduates were randomly assigned to one of three conditions: researcher-selected music, self-selected music, or a silent control condition. In Study 2, with 75 undergraduates, effects of music were compared to an active control (listening to a radio show). Negative affect was induced using a speech preparation and arithmetic task, followed by music listening or control. Self-reported anxiety and blood pressure were measured at baseline, post-induction, and post-intervention. Study 2 included state mindfulness as a dependent measure.
RESULTS
Study 1 indicated that participants who listened to music (self-selected and researcher-selected) reported significantly greater anxiety reduction than participants in the silent control condition. Music did not reduce anxiety compared to an active control in Study 2. However, music listening significantly increased levels of state mindfulness, which predicted lower anxiety after self-selected music listening.
CONCLUSIONS
Music may provide regulation in preparation for stressful events. Yet, the results of Study 2 indicate that other activities have similar benefits, and shows, for the first time, that music listening increases mindfulness following a stressor.",2020,Music did not reduce anxiety compared to an active control in Study 2.,"['70 undergraduates', 'young people']","['Self-Selected and Researcher-Selected Music Using Both Silent and Active Controls', 'active control (listening to a radio show', 'music listening', 'researcher-selected music, self-selected music, or a silent control condition', 'self-selected and researcher-selected music']","['Self-reported anxiety and blood pressure', 'anxiety reduction', 'anxiety', 'levels of state mindfulness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",2.0,0.0636066,Music did not reduce anxiety compared to an active control in Study 2.,"[{'ForeName': 'Jenny M', 'Initials': 'JM', 'LastName': 'Groarke', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'AnnMarie', 'Initials': 'A', 'LastName': 'Groarke', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hogan', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Costello', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lynch', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12185']
538,31545506,An indirect comparison of long-term efficacy of every-2-week dosing vs. recommended dosing of ixekizumab in patients who had static Physician's Global Assessment > 1 at week 12.,"BACKGROUND
Long-term efficacy and safety of ixekizumab [160 mg at week 0, then 80 mg every 2 weeks (Q2W) for 12 weeks, followed by every 4 weeks (Q4W) thereafter (i.e. Q2W/Q4W), which is the labelled psoriasis dosing where approved, except in Japan] have been established for the treatment of adults with moderate-to-severe plaque psoriasis. However, some patients may benefit from remaining on Q2W dosing beyond 12 weeks.
METHODS
Among patients who had static Physician's Global Assessment (sPGA) > 1 at week 12, efficacy through week 52 of continuous Q2W dosing in the IXORA-P study was compared indirectly with Q2W/Q4W in the integrated data from the UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies. The continuous Q4W dose group, which had comparable results across studies, was used as the common comparator.
RESULTS
In the IXORA-P study, among patients with sPGA > 1 at week 12, 64% of patients in the continuous Q2W group achieved sPGA ≤ 1 at week 52, which was statistically significantly higher than the 36% of patients with sPGA > 1 in the Q2W/Q4W group based on the integrated data from the UNCOVER studies (P = 0·0007). There were no clinically meaningful differences in frequencies of safety events between patients with sPGA ≤ 1 and patients with sPGA > 1 at week 12 in the IXORA-P study.
CONCLUSIONS
Among patients who did not have clear or almost clear skin at week 12, nearly 30% more patients who were treated continuously with ixekizumab Q2W in IXORA-P had clear or almost clear skin at week 52 when compared indirectly with those who were treated using the labelled psoriasis dosing in integrated UNCOVER studies. What's already known about this topic? Most patients with moderate-to-severe psoriasis who were given the labelled psoriasis dosing of ixekizumab [160-mg loading dose at week 0, 80 mg every 2 weeks (Q2W) through week 12, and 80 mg every 4 weeks (QW4) thereafter] respond quickly with a high percentage of skin clearance. Additionally, patients who achieve static Physician's Global Assessment (sPGA) ≤ 1 by week 12 tend to maintain this response, even after switching to Q4W. What does this study add? Here, we assessed whether patients with sPGA > 1 at week 12 benefited from receiving more frequent dosing beyond the first 12 weeks. The results showed that Q2W dosing beyond 12 weeks resulted in more patients achieving sPGA ≤ 1 by week 52 than the labelled psoriasis dosing among patients with sPGA > 1 at week 12.",2020,"There were no clinically meaningful differences in frequencies of safety events between patients with sPGA≤1 and patients with sPGA>1 at Week 12 in the IXORA-P study.
","['adults with moderate-to-severe plaque psoriasis', 'patients who had sPGA>1 at week 12']","['ixekizumab', 'ixekizumab Q2W']",['frequencies of safety events'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0282951,"There were no clinically meaningful differences in frequencies of safety events between patients with sPGA≤1 and patients with sPGA>1 at Week 12 in the IXORA-P study.
","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cauthen', 'Affiliation': 'MidState Skin Institute, Ocala, FL, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SkiN Centre for Dermatology and Probity Medical Research, Peterborough, and Queens University, Kingston, ON, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research, Brisbane, Queensland, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Dermatology, Graduate School of Medicine, Mie University, Tsu, Mie, Japan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Polzer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Osuntokun', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing, University Medical Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18550']
539,31793699,Alternative option labeling impacts decision-making in noninvasive prenatal screening.,"Prenatal genetic screening should be an informed, autonomous patient choice. Extrinsic factors which influence patient decision-making threaten the ethical basis of prenatal genetic screening. Prior research in the area of medical decision-making has identified that labeling may have unanticipated effects on patient perceptions and decision-making processes. This Internet-administered study explored the impact of option labeling on the noninvasive prenatal screening (NIPS) selections of US adults. A total of 1,062 participants were recruited through Amazon Mechanical Turk (MTurk) and randomly assigned to one of three possible label sets reflecting provider-derived and industry-derived option labels used in prenatal screening. Multinomial logistic regression analysis showed option labeling had a statistically significant impact on the NIPS selections of study participants (p = .0288). Outcomes of the Satisfaction with Decision Scale (SWD) indicated option labels did not play a role in participant satisfaction with screening selection. The results of this study indicate a need for further evaluation of the impact NIPS option labeling has on patient screening decisions in real-world clinical interactions. Clinical providers and testing laboratories offering NIPS should give careful consideration to the option labels used with prenatal screening so as to minimize influence on patient screening selection and decision-making processes.",2020,Outcomes of the Satisfaction with Decision Scale (SWD) indicated option labels did not play a role in participant satisfaction with screening selection.,"['1,062 participants were recruited through Amazon Mechanical Turk (MTurk', 'US adults']",['three possible label sets reflecting provider-derived and industry-derived option labels used in prenatal screening'],['Satisfaction with Decision Scale (SWD'],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0740178', 'cui_str': 'Antenatal Screening'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0222045'}]",1062.0,0.0395126,Outcomes of the Satisfaction with Decision Scale (SWD) indicated option labels did not play a role in participant satisfaction with screening selection.,"[{'ForeName': 'Camille F', 'Initials': 'CF', 'LastName': 'Fisher', 'Affiliation': 'Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Birkeland', 'Affiliation': 'Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Reiser', 'Affiliation': 'Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Christina G S', 'Initials': 'CGS', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Zikmund-Fisher', 'Affiliation': 'Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Petty', 'Affiliation': 'Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1191']
540,31797570,"Pharmacokinetics, Bioequivalence, and Safety Studies of Prucalopride in Healthy Chinese Subjects.","The objectives of the present study were to evaluate the bioequivalence of 2 tablet formulations of prucalopride, generic and branded, and to investigate relevant pharmacokinetic and safety profiles. This study was designed as a randomized, open-label, fasting, single-dose, crossover, and dual-period trial. After overnight fasting, 12 subjects were given prucalopride tablets via oral administration, and blood specimens were obtained up to 96 hours after dosing. Prucalopride concentrations in plasma were measured using ultraprecision liquid chromatography-tandem mass spectrometry followed by calculation of pharmacokinetic parameters. The safety of prucalopride was assessed throughout the study. The pharmacokinetics of prucalopride can be defined as a 2-compartment model with a long elimination phase. No significant differences were observed between the pharmacokinetic profiles of the generic and branded prucalopride tablets. Bioequivalence was evaluated using 90%CIs for the ratio test/reference of log area under the concentration-time curve over 96 hours, log area under the concentration-time curve to infinity, and log peak concentration from generic and branded tablets, which were 100.06-109.94%, 100.63-110.32%, and 95.84-113.08%, respectively. During administration of the medication, there were 18 adverse events in 6 subjects in the test formulation group and 19 cases of adverse events in 6 subjects in the reference formulation group (P > .05). No severe adverse effects were detected. These results suggest that generic and branded prucalopride tablets are bioequivalent and show similar safety profiles.",2020,No significant differences were observed between the pharmacokinetic profiles of the generic and branded prucalopride tablets.,['Healthy Chinese Subjects'],['Prucalopride'],"['severe adverse effects', 'pharmacokinetic profiles of the generic and branded prucalopride tablets', 'adverse events']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0913506', 'cui_str': '4-amino-5-chloro-N-(1-(3-methoxypropyl)-4-piperidinyl)-2,3-dihydro-1-benzofuran-7-carboxamide'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0913506', 'cui_str': '4-amino-5-chloro-N-(1-(3-methoxypropyl)-4-piperidinyl)-2,3-dihydro-1-benzofuran-7-carboxamide'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",12.0,0.044,No significant differences were observed between the pharmacokinetic profiles of the generic and branded prucalopride tablets.,"[{'ForeName': 'Ziye', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Chenxiang', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Xuyong', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Xuben', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmacy, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Dongchuan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Dikang Pharmaceutical Co, Ltd, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Leeway Biological Technology Co, Ltd, Jiangsu, China.'}, {'ForeName': 'Huafang', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Office of Drug Clinical Trial Institution, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Office of Drug Clinical Trial Institution, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Office of Drug Clinical Trial Institution, First Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.754']
541,31888928,Safety of switching from vitamin K antagonist to non-vitamin K antagonist oral anticoagulant in frail elderly with atrial fibrillation: rationale and design of the FRAIL-AF randomised controlled trial.,"INTRODUCTION
Clinical guidelines recommend non-vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs) for stroke prevention in most patients with atrial fibrillation (AF). Frail elderly were under-represented in the landmark NOAC-trials, leaving a knowledge gap on the optimal anticoagulant management (VKA or NOAC) in this increasing population. The aim of the Frail-AF (FRAIL-AF) study is to assess whether switching from international normalised ratio (INR)-guided VKA-management to a NOAC-based treatment strategy compared with continuing VKA-management is safe in frail elderly patients with AF.
METHODS AND ANALYSIS
The FRAIL-AF study is a pragmatic, multicentre, open-label, randomised controlled clinical trial. Frail elderly (age ≥75 years plus a Groningen Frailty Indicator score ≥3) who receive VKA-treatment for AF in the absence of a mechanical heart valve or severe mitral valve stenosis will be randomised to switch to a NOAC-based treatment strategy or to continue INR-guided VKA-management. Patients with severe renal impairment (estimated glomerular filtration rate <30 mL/min/1.73 m 2 ) will be excluded from randomisation. Based on existing trial evidence in non-frail patients, we will aim to explore whether NOAC-treatment is superior to VKA-therapy in reducing major or clinically relevant non-major bleeding events. Secondary outcomes include minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness. The follow-up period for all subjects is 12 months.
ETHICS AND DISSEMINATION
The protocol was approved by the Medical Research Ethics Committee of the University Medical Center Utrecht, the Netherlands and by the Central Committee on Research Involving Human Subjects, the Netherlands. All patients are asked written informed consent. Results are expected in 2022 and will be disseminated through peer-reviewed journals as well as presentations at national and international conferences.
TRIAL REGISTRATION NUMBER
EudraCT: 2017-000393-11; The Netherlands Trial Registry: 6721 (FRAIL-AF study).",2019,"Secondary outcomes include minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness.","['Frail elderly', 'frail elderly with atrial fibrillation', 'Frail elderly (age ≥75 years plus a Groningen Frailty Indicator score ≥3) who receive VKA-treatment for AF in the absence of a mechanical heart valve or severe mitral valve stenosis', 'patients with atrial fibrillation (AF', '2017-000393-11', 'Patients with severe renal impairment (estimated glomerular filtration rate', 'frail elderly patients with AF', 'Frail-AF (FRAIL-AF', 'non-frail patients']","['anticoagulant management (VKA or NOAC', 'switching from vitamin K antagonist', 'NOAC-based treatment strategy or to continue INR-guided VKA-management', 'vitamin K antagonist oral anticoagulants (NOACs) over vitamin K antagonists (VKAs', 'VKA-management', 'vitamin K antagonist oral anticoagulant']","['minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness']","[{'cui': 'C0079377', 'cui_str': 'Frail Elders'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4075877', 'cui_str': 'Groningen Frailty Indicator score'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026269', 'cui_str': 'Mitral Stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C3811844'}]","[{'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0642228', 'cui_str': 'NOAC'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.097323,"Secondary outcomes include minor bleeding, the composite of ischaemic and haemorrhagic stroke, health-related quality of life and cost-effectiveness.","[{'ForeName': 'Linda P T', 'Initials': 'LPT', 'LastName': 'Joosten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands l.p.t.joosten-3@umcutrecht.nl.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'van Doorn', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Arno W', 'Initials': 'AW', 'LastName': 'Hoes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Melchior C', 'Initials': 'MC', 'LastName': 'Nierman', 'Affiliation': 'Department of Thrombosis and Anticoagulation, Atalmedial Medical Diagnostics Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Nynke M', 'Initials': 'NM', 'LastName': 'Wiersma', 'Affiliation': 'Department of Thrombosis and Anticoagulation, Diagnostic Center Saltro, Utrecht, The Netherlands.'}, {'ForeName': 'Huiberdina L', 'Initials': 'HL', 'LastName': 'Koek', 'Affiliation': 'Department of Geriatrics, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Martin E W', 'Initials': 'MEW', 'LastName': 'Hemels', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Menno V', 'Initials': 'MV', 'LastName': 'Huisman', 'Affiliation': 'Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Kit C', 'Initials': 'KC', 'LastName': 'Roes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rutger M', 'Initials': 'RM', 'LastName': 'van den Bor', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Wim F', 'Initials': 'WF', 'LastName': 'Buding', 'Affiliation': 'Member of the Dutch Organisation for patients using anticoagulant medication, CTD Nederland, Leiden, The Netherlands.'}, {'ForeName': 'Frans H', 'Initials': 'FH', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Geersing', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-032488']
542,31826899,Pragmatic trial evaluating the effectiveness of a patient navigator to decrease emergency room utilisation in transition age youth with chronic conditions: the Transition Navigator Trial protocol.,"INTRODUCTION
Transition to adult care is a challenging and complex process for youth with special healthcare needs. We aim to compare effectiveness of a patient navigator service in reducing emergency room (ER) use among adolescents with chronic health conditions transitioning to adult care.
METHODS AND ANALYSIS
Pragmatic randomised controlled trial parallel group design comparing ER visit rates between patients with access to a personalised navigator intervention compared with usual care. Unit of randomisation is the patient. Treatment assignment will not be blinded. Embedded qualitative study to understand navigator's role and cost analysis attributable to the intervention will be performed. Patients aged 16-21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals. Sample size will be 300 in each arm. Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management. Primary outcome is ER visit rate during observation period. Secondary outcomes are ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score at 6 and 18 months post-randomisation. Poisson regression will compare rates of ER/urgent care visits between navigator and control participants, using intention to treat principle. Cost analysis of the intervention will be conducted. Thematic analysis will be used to identify perceptions of stakeholders regarding the role of navigators.
ETHICS AND DISSEMINATION
Ethics approval was obtained from the University of Calgary Conjoint Health Research Ethics Board (REB #162561) and the University of Alberta Health Research Ethics Board (Pro00077325). Our team is composed of diverse stakeholders who are committed to improving transition of care who will assist with dissemination of results.
TRIAL REGISTRATION NUMBER
NCT03342495.",2019,"Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management.","['transition age youth with chronic conditions', 'adolescents with chronic health conditions transitioning to adult care', 'Patients aged 16-21 years, followed within a chronic disease clinic, expected to be transferred to adult care within 12 months and residing in Alberta during study period will be recruited from three tertiary care paediatric hospitals', 'patients with access to a']","['patient navigator to decrease emergency room utilisation', 'Navigator intervention', 'patient navigator service', 'personalised navigator intervention compared with usual care']","['ambulatory and inpatient care utilisation measures, as well as Transition Readiness Assessment Questionnaire score, and Short-Form Health Survey 12 (SF-12) score', 'ER visit rate during observation period']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178922', 'cui_str': 'Transfer from Pediatric to Adult Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}]","[{'cui': 'C1709488', 'cui_str': 'Patient Navigators'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4720924', 'cui_str': 'Transition readiness assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",,0.186692,"Navigator intervention over 24 months is designed to assist participants in four domains: transition preparation, health system brokering, socioeconomic determinants of health and self-management.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Samuel', 'Affiliation': 'Section of Nephrology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada susan.samuel@ahs.ca.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Dimitropoulos', 'Affiliation': 'Faculty of Social Work, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kyleigh', 'Initials': 'K', 'LastName': 'Schraeder', 'Affiliation': ""Alberta Children's Hospital Research Institute, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Klarenbach', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Guilcher', 'Affiliation': ""Section of Pediatric Oncology and Blood and Marrow Transplant, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Pacaud', 'Affiliation': 'Section of Endocrinology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Pinzon', 'Affiliation': 'Section of Adolescent Medicine, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Lang', 'Affiliation': 'Department of Emergency Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Andrew', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lonnie', 'Initials': 'L', 'LastName': 'Zwaigenbaum', 'Affiliation': 'Department of Pediatrics, Autism Research Centre, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'McBrien', 'Affiliation': 'Department of Family Medicine, Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Hamiwka', 'Affiliation': 'Section of Nephrology, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mackie', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}]",BMJ open,['10.1136/bmjopen-2019-034309']
543,31893730,Individual predictors of response to biofeedback training for second-language production.,"While recent research suggests that visual biofeedback can facilitate speech production training in clinical populations and second language (L2) learners, individual learners' responsiveness to biofeedback is highly variable. This study investigated the hypothesis that the type of biofeedback provided, visual-acoustic versus ultrasound, could interact with individuals' acuity in auditory and somatosensory domains. Specifically, it was hypothesized that learners with lower acuity in a sensory domain would show greater learning in response to biofeedback targeting that domain. Production variability and phonological awareness were also investigated as predictors. Sixty female native speakers of English received 30 min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback, for each of two Mandarin vowels. On average, participants showed a moderate magnitude of improvement (decrease in Euclidean distance from a native-speaker target) across both vowels and biofeedback conditions. The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research. Specifically, high phonological awareness and low production variability post-training were associated with better outcomes, although these effects were mediated by vowel target. This line of research could have implications for personalized learning in both L2 pedagogy and clinical practice.",2019,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[""individuals' acuity in auditory and somatosensory domains"", 'Sixty female native speakers of English received']","['visual biofeedback', '30\u2009min of training, randomly assigned to feature visual-acoustic or ultrasound biofeedback', 'visual-acoustic versus ultrasound', 'biofeedback training']","['Euclidean distance', 'Production variability and phonological awareness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}]",60.0,0.0456901,"The hypothesis of an interaction between sensory acuity and biofeedback type was not supported, but phonological awareness and production variability were predictive of learning gains, consistent with previous research.","[{'ForeName': 'Joanne Jingwen', 'Initials': 'JJ', 'LastName': 'Li', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Ayala', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Harel', 'Affiliation': 'Department of Applied Statistics, Social Science, and Humanities, New York University, 246 Greene Street, 3rd Floor, New York, New York 10003, USA.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Shiller', 'Affiliation': ""École d'orthophonie et d'audiologie, Université de Montréal, Case Postale 6128, Succursale Centre-ville, Montréal, Québec, H3C 3J7, Canada.""}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'McAllister', 'Affiliation': 'Department of Communicative Sciences and Disorders, New York University, 665 Broadway, Suite 900, New York, New York 10012, USA.'}]",The Journal of the Acoustical Society of America,['10.1121/1.5139423']
544,31895174,Sublingual Versus Swallowed Morphine: A Comparison.,"BACKGROUND
The optimal route for immediate-release morphine administration is controversial. The known physical characteristics of morphine that allow absorption are counter to the unproven belief that sublingual morphine is absorbed more quickly.
OBJECTIVE
The aim of this study was to compare swallowed and sublingual morphine for effects on plasma morphine concentrations (PMCs), pain relief, and taste.
METHODS
Ten participants with cancer (mean age, 50 ± 12 years) received a 10-mg morphine tablet in a randomized crossover design with repeated premeasure and postmeasure for 60 minutes. Measures included PMC and visual analog scale (100 mm) scores for pain relief and taste.
RESULTS
Interindividual variability in maximum PMC was 25-fold (2.2-55 ng/mL). At 60 minutes, sublingual and swallowed routes were not significantly different for mean area under the curve for PMC (swallowed, 329 ± 314 ng/mL; sublingual, 314 ± 299 ng/mL) or for mean pain relief scores (swallowed, 81 ± 32; sublingual, 78 ± 31). Taste scores at 5 (P < .05), 10 (P < .04), 15 (P < .02), and 20 (P < .04) minutes after swallowed doses were significantly less unpleasant than after sublingual doses.
CONCLUSION
In this crossover design, between-group PMCs were similar for sublingual and swallowed morphine and resulted in a similar level of pain relief. Given the 25-fold across-participant differences in PMC after the same dose, additional research is warranted to identify the sources of this tremendous variability in PMC.
IMPLICATIONS FOR PRACTICE
Because of unpleasant taste, which could influence adherence and subsequent analgesia, clinicians should encourage patients to swallow their morphine doses and restrict use of sublingual morphine to individuals who are unable to swallow.",2021,"At 60 minutes, sublingual and swallowed routes were not significantly different for mean area under the curve for PMC (swallowed, 329 ± 314 ng/mL; sublingual, 314 ± 299 ng/mL) or for mean pain relief scores (swallowed, 81 ± 32; sublingual, 78 ± 31).","['Ten participants with cancer (mean age, 50 ± 12 years']","['morphine', 'morphine tablet', 'sublingual and swallowed morphine', 'Sublingual Versus Swallowed Morphine', 'sublingual morphine']","['mean pain relief scores', 'pain relief', 'PMC and visual analog scale (100 mm) scores for pain relief and taste', 'plasma morphine concentrations (PMCs), pain relief, and taste', 'Taste scores']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1568303', 'cui_str': 'poly(2-methacryloyloxyethyl phosphorylcholine-co-n-stearyl methacrylate)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",10.0,0.108766,"At 60 minutes, sublingual and swallowed routes were not significantly different for mean area under the curve for PMC (swallowed, 329 ± 314 ng/mL; sublingual, 314 ± 299 ng/mL) or for mean pain relief scores (swallowed, 81 ± 32; sublingual, 78 ± 31).","[{'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Dyal', 'Affiliation': 'Author Affiliations: Department of Biobehavioral Nursing Science, College of Nursing (Drs Dyal, Powell-Roach, Yoon, and Wilkie), and Department of Community Dentistry and Behavioral Science, College of Dentistry (Dr Powell-Roach), University of Florida, Gainesville; Center for Palliative Care Research & Education (Drs Dyal, Powell-Roach, Yoon, and Wilkie), Gainesville, Florida; Multicare Deaconess Cancer and Blood Specialty Center (Dr Robison); and School of Nursing and Human Physiology, Gonzaga University (Dr Robison), Spokane, Washington; and University of Wisconsin Carbone Cancer Center (Ms Campbell), Madison.'}, {'ForeName': 'Keesha L', 'Initials': 'KL', 'LastName': 'Powell-Roach', 'Affiliation': ''}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Robison', 'Affiliation': ''}, {'ForeName': 'Bethaney', 'Initials': 'B', 'LastName': 'Campbell', 'Affiliation': ''}, {'ForeName': 'Saunjoo L', 'Initials': 'SL', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000784']
545,31901082,The effects of extra virgin olive oil and canola oil on inflammatory markers and gastrointestinal symptoms in patients with ulcerative colitis.,"BACKGROUND/OBJECTIVES
Ulcerative colitis (UC) is an immune-mediated disease that causes inflammation in the gastrointestinal tract. Diet has an important role in the treatment of UC. This study aimed to compare the effects of extra virgin olive oil (EVOO), as a functional food, with canola oil in the treatment of UC.
SUBJECTS/METHODS
Forty patients were participating in this crossover clinical trial. Thirty two patients completed two intervention rounds. Blood samples were taken before and after 20 days intervention. Disease activity score and gastrointestinal symptoms were evaluated using the Mayo score and gastrointestinal symptom rating scale (GSRS) respectively.
RESULTS
Erythrocyte sedimentation rate (p = 0.03) and high-sensitivity C-reactive protein (p < 0.001) were decreased significantly after EVOO consumption. Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS were reduced significantly after EVOO consumption (p < 0.05).
CONCLUSIONS
Intake of EVOO decreased the inflammatory markers and improved gastrointestinal symptoms in UC patients. It seems this functional food can be beneficial in the treatment of UC as a complementary medicine.",2020,"Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS were reduced significantly after EVOO consumption (p < 0.05).
","['Ulcerative colitis (UC', 'UC patients', 'Forty patients were participating in this crossover clinical trial', 'patients with ulcerative colitis']","['extra virgin olive oil and canola oil', 'extra virgin olive oil (EVOO']","['Disease activity score and gastrointestinal symptoms', 'gastrointestinal symptoms', 'Mayo score and gastrointestinal symptom rating scale (GSRS) respectively', 'Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS', 'inflammatory markers and gastrointestinal symptoms', 'Erythrocyte sedimentation rate', 'high-sensitivity C-reactive protein']","[{'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}]","[{'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0426636', 'cui_str': 'Urgent desire for stool (finding)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",40.0,0.0271139,"Bloating, constipation, fecal urgency, incomplete defecation, and final GSRS were reduced significantly after EVOO consumption (p < 0.05).
","[{'ForeName': 'Mehrnaz', 'Initials': 'M', 'LastName': 'Morvaridi', 'Affiliation': 'Diabetes Research Center, Health Research Institute, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jafarirad', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. sjafarirad@gmail.com.'}, {'ForeName': 'Seyed Saeed', 'Initials': 'SS', 'LastName': 'Seyedian', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Pezhman', 'Initials': 'P', 'LastName': 'Alavinejad', 'Affiliation': 'Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Cheraghian', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0549-z']
546,31796495,"Evaluation of titanium mesh cranioplasty and polyetheretherketone cranioplasty: protocol for a multicentre, assessor-blinded, randomised controlled trial.","INTRODUCTION
Cranioplasty is a common surgery in neurosurgery department. However, restoring the integrity of skull brings many challenges to surgeons, and the selection of ideal implant materials is throughout the history of cranioplasty. Although titanium mesh was still preferred by many neurosurgeons in cranial reconstruction, the new polyetheretherketone (PEEK) material, for example, is gaining popularity for craniofacial reconstruction today. There remain limited data that compare the outcome of PEEK cranioplasty and titanium mesh cranioplasty. It is necessary to conduct a study to compare outcome of different materials for cranioplasty.
METHODS/DESIGN
In this multicentre, assessor-blinded, randomised controlled study, we will randomise 140 patients in a 1:1 ratio to PEEK cranioplasty versus titanium cranioplasty. Eligible patients are adults who were diagnosed with cranial defect (due to severe traumatic brain injury, ischaemic stroke, haemorrhagic stroke, infiltrative tumour and so on), the defect size is over 25 cm 2 , and they need to agree to participate in this trial. Instead of standard examinations, the enrolled patients receive neurological, motor, cognitive function and cerebral hemodynamics examinations as well as cosmetic evaluation. The procedures are repeated 3, 6 months after cranioplasty. The primary outcome, defined as infection or implant exposure after surgery, is the implant failure rate within 6 months. Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.
ETHICS AND DISSEMINATION
This trial protocol has been approved by Biomedical Research Ethics Committee of West China Hospital of Sichuan University. All patients will be fully informed the implant materials, potential complications after surgery, responsibilities during the trial, and they will sign the informed consent before joining in this trial. If the patient's cognitive function is impaired, the patient's next of kin would be carefully informed. The results will be disseminated through academic conferences, student theses and will be published in a peer-reviewed journal.
TRAIL REGISTRATION NUMBER
ChiCTR1900024625; Pre-results.",2019,"Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.
","['West China Hospital of Sichuan University', 'randomise 140 patients in a 1:1 ratio to PEEK cranioplasty versus titanium cranioplasty', 'Eligible patients are adults who were diagnosed with cranial defect (due to severe traumatic brain injury, ischaemic stroke, haemorrhagic stroke, infiltrative tumour and so on']","['titanium mesh', 'titanium mesh cranioplasty and polyetheretherketone cranioplasty']","['infection or implant exposure after surgery, is the implant failure rate', 'postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0196112', 'cui_str': 'Repair of bone of skull'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0196112', 'cui_str': 'Repair of bone of skull'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0854676', 'cui_str': 'Failure of implant'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",140.0,0.175153,"Secondary outcomes include postoperative complication rates, neurological outcomes, motor function, cerebral hemodynamics, cosmetic outcome and the total cost over a 6-month period.
","[{'ForeName': 'Jingguo', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yikai', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Xuepei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Health Ministry Key Laboratory of Chronobiology, College of Basic Medicine and Forensic Medicine, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Institute of Neurology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.""}, {'ForeName': 'Junwen', 'Initials': 'J', 'LastName': 'Guan', 'Affiliation': 'Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, Sichuan, China guanjunwen_scu@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-033997']
547,31801940,Ofatumumab maintenance prolongs progression-free survival in relapsed chronic lymphocytic leukemia: final analysis of the PROLONG study.,"We report the final analysis of the PROLONG study on ofatumumab maintenance in relapsed chronic lymphocytic leukemia (CLL). In all, 480 patients with CLL in complete or partial remission after second- or third-line treatment were randomized 1:1 to ofatumumab (300 mg first week, followed by 1000 mg every 8 weeks for up to 2 years) or observation. Median follow-up duration was 40.9 months. Median progression-free survival was 34.2 and 16.9 months for ofatumumab and observation arms, respectively, (hazard ratio, 0.55 [95% confidence interval, 0.43-0.70]; P < 0.0001). Median time to next treatment for ofatumumab and observation arms, respectively, was 37.4 and 27.6 months (0.72 [0.57-0.91]; P = 0.0044). Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]). Grade ≥ 3 adverse events occurred in 62% and 51% of patients in ofatumumab and observation arms, respectively, the most common being neutropenia (23% and 10%), pneumonia (13% and 12%) and febrile neutropenia (6% and 4%). Up to 60 days after the last treatment, four deaths were reported in the ofatumumab arm versus six in the observation arm, none considered related to ofatumumab. Ofatumumab maintenance significantly prolonged progression-free survival in patients with relapsed CLL and was well tolerated.",2019,Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]).,"['relapsed chronic lymphocytic leukemia (CLL', 'relapsed chronic lymphocytic leukemia', '480 patients with CLL in complete or partial remission after second- or third-line treatment']",['Ofatumumab maintenance'],"['Median progression-free survival', 'tolerated', 'Grade\u2009≥', 'progression-free survival', 'Median time', 'neutropenia', 'pneumonia', 'febrile neutropenia', 'Overall survival', '3 adverse events']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C2986605', 'cui_str': 'Third line treatment'}]","[{'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",480.0,0.0753233,Overall survival was similar in both arms; median was not reached (0.99 [0.72-1.37]).,"[{'ForeName': 'Marinus', 'Initials': 'M', 'LastName': 'van Oers', 'Affiliation': 'Academisch Medisch Centrum and HOVON, Amsterdam, The Netherlands. m.h.vanoers@amc.uva.nl.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Smolej', 'Affiliation': 'University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Petrini', 'Affiliation': 'Azienda Ospedaliero Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Universitair Ziekenhuis Gent, Gent, Belgium.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Albert Schweitzer Ziekenhuis Dordrecht and HOVON, Dordrecht, The Netherlands.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Hiya', 'Initials': 'H', 'LastName': 'Banerjee', 'Affiliation': 'Novartis Oncology, East Hanover, NJ, USA.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Stefanelli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Hoever', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Geisler', 'Affiliation': 'Rigshospitalet-Koebenhavn, Copenhagen, Denmark.'}]",Blood cancer journal,['10.1038/s41408-019-0260-2']
548,31857319,Prostate cancer androgen receptor splice variant 7 biomarker study - a multicentre randomised feasibility trial of biomarker-guided personalised treatment in patients with advanced prostate cancer (the VARIANT trial) study protocol.,"INTRODUCTION
Prostate cancer is the most common male cancer with one in four developing non-curable metastatic disease. Initial treatment responses to hormonal therapies are transient and further management options lie between (1) further hormone therapy or (2) a non-hormonal approach involving additional chemotherapy or molecular radiotherapy (radium-223). There is no clear rationale for choosing between these mechanistically different treatment approaches. The biology of hormone resistance is driven through abnormal androgen receptor activity and we can assay this through a blood test measuring androgen receptor variant 7 (AR-V7) expression in circulating tumour cells. Despite increasing evidence supporting AR-V7's role as a prognostic marker, the clinical utility of such measures remains unknown in helping personalise treatment decisions.
METHODS AND DESIGN
The VARIANT feasibility trial is a pragmatic design, to be run over 18 months with participants randomised into the intervention arm receiving biomarker (AR-V7) guided clinical treatment and participants randomised into the control arm with conventional standard management (no biomarker guidance). AR-V7 positive participants (likely to be insensitive to further hormone treatment) will receive chemotherapy or in other cases radium-223 (where routinely available). Seventy male ≥18 years old participants with metastatic castrate resistant prostate cancer clinically indicated to proceed to further hormone therapy or chemotherapy, will be recruited from three National Health Service Trusts based in England, Scotland and Wales. The feasibility primary outcome is willingness of patients to be randomised and clinicians to recruit to a biomarker-based treatment strategy, with trial data informing the basis of a definitive and appropriately powered randomised control trial.
ETHICS AND DISSEMINATION
Formal ethics review was undertaken with a favourable opinion, through Wales NRES Committee 2 18/WA/0419. Findings to be disseminated through patient and professional organisations that have expressed their support, media outlets and peer-reviewed journal publication.
TRIAL REGISTRATION NUMBER
ISRCTN10246848; pre-results.",2019,"The feasibility primary outcome is willingness of patients to be randomised and clinicians to recruit to a biomarker-based treatment strategy, with trial data informing the basis of a definitive and appropriately powered randomised control trial.
","['Seventy male ≥18 years old participants with metastatic castrate resistant prostate cancer clinically indicated to proceed to further hormone therapy or chemotherapy, will be recruited from three National Health Service Trusts based in England, Scotland and Wales', 'patients with advanced prostate cancer']","['biomarker-guided personalised treatment', 'control arm with conventional standard management (no biomarker guidance', 'chemotherapy or molecular radiotherapy (radium-223', 'intervention arm receiving biomarker (AR-V7) guided clinical treatment']",[],"[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",[],70.0,0.178296,"The feasibility primary outcome is willingness of patients to be randomised and clinicians to recruit to a biomarker-based treatment strategy, with trial data informing the basis of a definitive and appropriately powered randomised control trial.
","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Clark', 'Affiliation': 'Translational and Clinical Research Institute, NU Cancer, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK emma.clark@ncl.ac.uk.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Morton', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Shriya', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': 'Population Health Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Population Health Sciences, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hancock', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Trial Managment Group, VARIANT Trial, Newcastle-Upon-Tyne, UK.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bahl', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, Bristol, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Crabb', 'Affiliation': 'University of Southampton, Southampton, UK.'}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Queen's University Belfast, Belfast, Belfast, UK.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pedley', 'Affiliation': 'Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Research, Velindre Cancer Centre, Cardiff, Cardiff, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Heer', 'Affiliation': 'Translational and Clinical Research Institute, NU Cancer, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",BMJ open,['10.1136/bmjopen-2019-034708']
549,31857942,"Engaging Young Men as Community Health Leaders in an STI and Intimate Partner Violence Prevention Trial in Dar es Salaam, Tanzania.","Background
This article presents lessons learned from a microfinance and health intervention for young men designed to prevent sexually transmitted infections (STI) and intimate partner violence (IPV) in Dar es Salaam, Tanzania. We describe the different strategies we used to identify and train young men to become change agents within their social networks.
Description
A cluster-randomized trial with 60 camps was undertaken in the Kinondoni District of Dar es Salaam. A total of 170 members from 30 intervention camps were trained in March 2014 as popular opinion leaders (POLs), whom we call Camp Health Leaders (CHLs). We describe the process of nominating, training, and retaining CHLs. We also describe our monitoring process, which included the collection of weekly diaries assessing topics discussed, number of peers engaged in conversations, reactions of peers, and challenges faced.
Lessons learned
POLs within naturally existing social networks can be engaged in STI and IPV prevention initiatives. Continuous efforts in retention, such as holding community advisory board (CAB) meetings, developing prevention slogans and t-shirts, and offering small grants to POL teams for intervention activities, were important to keeping POLs engaged in the intervention. Further, booster-training sessions were critical to maintain the message of the project and ensure that the challenges POLs face with implementing the programs were addressed in a timely manner.
Conclusion
Recruiting POLs in a Tanzanian urban setting and engaging them in STI and IPV reduction through social networks is possible. Training POLs in health information and interpersonal communication is important. Utilizing booster sessions and a variety of retention strategies for POLs in programs that aim to reduce IPV and STI infections among young men is essential to maintain the health leaders' engagement in the intervention as well as intervention fidelity.",2019,A cluster-randomized trial with 60 camps was undertaken in the Kinondoni District of Dar es Salaam.,"['A total of 170 members from 30 intervention camps were trained in March 2014 as popular opinion leaders (POLs), whom we call Camp Health Leaders (CHLs', 'young men designed to prevent sexually transmitted infections (STI) and intimate partner violence (IPV) in Dar es Salaam, Tanzania', '60 camps was undertaken in the Kinondoni District of Dar es Salaam', 'young men']",['microfinance and health intervention'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}]",[],170.0,0.0184436,A cluster-randomized trial with 60 camps was undertaken in the Kinondoni District of Dar es Salaam.,"[{'ForeName': 'Lusajo J', 'Initials': 'LJ', 'LastName': 'Kajula', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences (MUHAS), Off United Nations Road, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mrema N', 'Initials': 'MN', 'LastName': 'Kilonzo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences (MUHAS), Off United Nations Road, Dar es Salaam, Tanzania.'}, {'ForeName': 'Donaldson F', 'Initials': 'DF', 'LastName': 'Conserve', 'Affiliation': 'University of South Carolina.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Mwikoko', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences (MUHAS), Off United Nations Road, Dar es Salaam, Tanzania.'}, {'ForeName': 'Deus', 'Initials': 'D', 'LastName': 'Kajuna', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences (MUHAS), Off United Nations Road, Dar es Salaam, Tanzania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Balvanz', 'Affiliation': 'University of North Carolina - Chapel Hill.'}, {'ForeName': 'Thespina J', 'Initials': 'TJ', 'LastName': 'Yamanis', 'Affiliation': 'American University.'}, {'ForeName': 'Marta I', 'Initials': 'MI', 'LastName': 'Mulawa', 'Affiliation': 'Duke University.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Hill', 'Affiliation': 'University of North Carolina - Chapel Hill.'}, {'ForeName': 'Jessie K', 'Initials': 'JK', 'LastName': 'Mbwambo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences (MUHAS), Off United Nations Road, Dar es Salaam, Tanzania.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'University of North Carolina - Chapel Hill.'}]","Global social welfare : research, policy & practice",['10.1007/s40609-018-00134-z']
550,31764194,The role of computer-based clinical decision support systems to deliver protective mechanical ventilation.,"PURPOSE OF REVIEW
Mechanical ventilation of adults and children with acute respiratory failure necessitates balancing lung and diaphragm protective ventilation. Computerized decision support (CDS) offers advantages in circumstances where complex decisions need to be made to weigh potentially competing risks, depending on the physiologic state of the patient.
RECENT FINDINGS
Significant variability in how ventilator protocols are applied still exists and clinical data show that there continues to be wide variability in ventilator management. We have developed a CDS, which we are currently testing in a Phase II randomized controlled trial. The CDS is called Real-time Effort Driven ventilator management (REDvent). We will describe the rationale and methods for development of CDS for lung and diaphragm protective ventilation, using the REDvent CDS as an exemplar.
SUMMARY
Goals for achieving compliance and physiologic objectives can be met when CDS instructions are simple and explicit, provide the clinician with the underlying rule set, permit acceptable reasons for declining and allow for iterative adjustments.",2020,"Computerized decision support (CDS) offers advantages in circumstances where complex decisions need to be made to weigh potentially competing risks, depending on the physiologic state of the patient.
",['adults and children with acute respiratory failure necessitates balancing lung and diaphragm protective ventilation'],['Computerized decision support (CDS'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure (disorder)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}]",[],,0.0361634,"Computerized decision support (CDS) offers advantages in circumstances where complex decisions need to be made to weigh potentially competing risks, depending on the physiologic state of the patient.
","[{'ForeName': 'Robinder G', 'Initials': 'RG', 'LastName': 'Khemani', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Hotz', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California.""}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Sward', 'Affiliation': 'College of Nursing and Department of Biomedical Informatics, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Christopher J L', 'Initials': 'CJL', 'LastName': 'Newth', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California.""}]",Current opinion in critical care,['10.1097/MCC.0000000000000688']
551,31856374,Esomeprazole vs pantoprazole effects on cyclosporine levels in kidney transplantation: A randomized clinical trial.,"Renal allograft survival requires multiple immunosuppressive drugs. This strategy may lead to gastric complications that necessitate gastro-protective medications, notably, proton pump inhibitors (PPI). This study aimed to compare the influence of pantoprazole and esomeprazole on serum cyclosporine trough levels (C 0 ) in renal transplant recipients (RTR). A prospective, parallel, open-label trial was conducted on 47 adult RTR receiving cyclosporine doses adjusted to attain trough concentrations of 100 to 150 μg/L, mycophenolate mofetil (MMF) 750 mg q12 hour and prednisolone at 5 mg daily at Nasser Institute, Cairo, Egypt from January to September 2016. Patients were randomized into the esomeprazole group (25) or pantoprazole group (22) receiving the same dose (40 mg once daily). The study outcomes included clinical signs of rejection and renal function decline, assessed by elevations in serum creatinine, caused by cyclosporine level variations in either of the two study groups. Renal function, C 0 and CBC measurements were measured at baseline and monthly for 6 months. The mean C 0 values were higher in the pantoprazole group than in the esomeprazole group in the sixth month only (P = .007). Serum creatinine level was lower in the sixth month than at baseline in the esomeprazole group (P = .004). There were no signs of rejection biochemical or clinical in any of the study groups. In conclusion, PPIs should be used with caution and doses should be titrated to reach the C 0 targets in RTR, which is of more importance in pantoprazole than esomeprazole to avoid C 0 level elevation or decline affecting the allograft function.",2020,Serum creatinine level was lower in the sixth month than at baseline in the esomeprazole group (p = 0.004).,"['47 adult RTR receiving; cyclosporine doses adjusted to attain trough concentrations of 100-150 μg/L', 'kidney transplantation', 'renal transplant recipients (RTR']","['Esomeprazole', 'esomeprazole', 'prednisolone', 'pantoprazole and esomeprazole', 'pantoprazole', 'mycophenolate mofetil (MMF']","['clinical signs of rejection and renal function decline', 'Renal function, C 0 and CBC measurements', 'mean C 0 values', 'cyclosporine levels', 'Serum creatinine level', 'serum cyclosporine trough levels', 'Renal allograft survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600061', 'cui_str': 'Serum creatinine level - finding'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",47.0,0.051394,Serum creatinine level was lower in the sixth month than at baseline in the esomeprazole group (p = 0.004).,"[{'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'El-Bohy', 'Affiliation': 'Department of Clinical Pharmacy, Future University in Egypt, Cairo, Egypt.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El Sharkawy', 'Affiliation': 'Department of Internal Medicine & Nephrology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Soheir', 'Initials': 'S', 'LastName': 'Abo-Elazm', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shahin', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Bchari', 'Affiliation': 'Department of Internal Medicine & Nephrology, Faculty of Medicine, Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Azza', 'Initials': 'A', 'LastName': 'Mancy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'El Hamamsy', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}]","Therapeutic apheresis and dialysis : official peer-reviewed journal of the International Society for Apheresis, the Japanese Society for Apheresis, the Japanese Society for Dialysis Therapy",['10.1111/1744-9987.13464']
552,31856379,Effects of a healthy diet enriched or not with pecan nuts or extra-virgin olive oil on the lipid profile of patients with stable coronary artery disease: a randomised clinical trial.,"BACKGROUND
The present study aimed to assess the effect of a healthy diet, enriched or not with pecan nuts or extra-virgin olive oil, on the lipid profile of patients with stable coronary artery disease (CAD).
METHODS
This was a randomised clinical trial conducted for 12 weeks with patients aged between 40 and 80 years with stable CAD for more than 60 days. Individuals were randomised into groups [control group (CG) with 67 patients, pecan nut group (PNG) with 68 patients and olive oil group (OOG) with 69 patients]. The CG was prescribed a healthy diet according to the nutritional guidelines; the PNG was prescribed the same healthy diet plus 30 g day -1 of pecan nuts; and the OOG was prescribed a healthy diet plus 30 mL day -1 of extra-virgin olive oil.
RESULTS
In total, 204 subjects were submitted to an intention-to-treat analysis. After adjustment for baseline values and type of statin used, there was no difference regarding low-density lipoprotein (LDL)-cholesterol (primary outcome), high-density lipoprotein (HDL)-cholesterol, LDL-cholesterol/HDL-cholesterol ratio and HDL-cholesterol/triglycerides ratio according to groups. However, the PNG exhibited a significant reduction in non-HDL-cholesterol levels [PNG: 114.9 (31) mg dL -1 ; CG: 127 (33.6) mg dL -1 ; OOG: 126.6 (37.4) mg dL -1 ; P = 0.033] and in the total cholesterol/HDL-cholesterol ratio [PNG: 3.7 (0.7); CG: 4.0 (0.8); OOG: 4.0 (0.8); P = 0.044] compared to the CG and OOG.
CONCLUSIONS
Supplementing a healthy diet with 30 g day -1 of pecan nuts for 12 weeks did not improve LDL-cholesterol levels but may improve other lipid profile markers in patients with stable CAD.",2020,"However, the PNG exhibited a significant reduction in non-HDL-cholesterol levels [PNG: 114.9 (31) ","['patients with stable coronary artery disease (CAD', 'patients with stable CAD', 'patients with stable coronary artery disease', '204 subjects were submitted to an intention-to-treat analysis', '12\xa0weeks with patients aged between 40 and 80\xa0years with stable CAD for more than 60\xa0days']","['pecan nut group (PNG) with 68 patients and olive oil group (OOG', 'healthy diet enriched or not with pecan nuts or extra-virgin olive oil', 'OOG was prescribed a healthy diet plus 30\xa0mL day -1 of extra-virgin olive oil', 'dL', 'healthy diet, enriched or not with pecan nuts or extra-virgin olive oil', 'mg dL']","['non-HDL-cholesterol levels', 'low-density lipoprotein (LDL)-cholesterol (primary outcome), high-density lipoprotein (HDL)-cholesterol, LDL-cholesterol/HDL-cholesterol ratio and HDL-cholesterol/triglycerides ratio', 'total cholesterol/HDL-cholesterol ratio', 'LDL-cholesterol levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0440289', 'cui_str': 'Pecan nut (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0555061', 'cui_str': 'Virgin (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",204.0,0.0832412,"However, the PNG exhibited a significant reduction in non-HDL-cholesterol levels [PNG: 114.9 (31) ","[{'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Campos', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'V L', 'Initials': 'VL', 'LastName': 'Portal', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Markoski', 'Affiliation': 'Graduate Program in Nutrition Sciences, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Quadros', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}, {'ForeName': 'Â C', 'Initials': 'ÂC', 'LastName': 'Bersch-Ferreira', 'Affiliation': 'HCor Research Institute, Coracao Hospital (IP-HCor), São Paulo, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Garavaglia', 'Affiliation': 'Graduate Program in Nutrition Sciences, Federal University of Health Sciences of Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marcadenti', 'Affiliation': 'Graduate Program in Health Sciences (Cardiology), Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology (IC/FUC), Porto Alegre, Brazil.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12727']
553,31859211,"Achieving Low Radiation Dose in ""One-Stop"" Myocardial Computed Tomography Perfusion Imaging in Coronary Artery Disease Using 16-cm Wide Detector CT.","RATIONALE AND OBJECTIVES
To investigate the feasibility of ""one-stop"" myocardial computed tomography perfusion (CTP) imaging (combined anatomy, perfusion, and function) in coronary artery disease using 16-cm wide detector CT, compared to conventional coronary CT angiography (CCTA).
MATERIALS AND METHODS
442 patients with suspected coronary artery disease were randomly divided into two groups. Patients in group A underwent ""one-stop"" CTP, whereas group B underwent conventional CCTA. Image quality of CT images was assessed. Radiation and contrast medium doses and scan time of the two groups were recorded. Group A was further divided into four subgroups according to the degree of coronary artery stenosis, for which transmural perfusion ratio (TPR) and left ventricular ejection fraction (LVEF) were measured.
RESULTS
Scan time was 73.1 ± 7.3 (s) longer in group A than in group B with 11.7% reduction of radiation dose (p < 0.001) and no significant difference in image quality was noted. Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2 =36.98, p < 0.001) were observed among four subgroups. A negative correlation was found between the degree of coronary artery stenosis and TPR of the corresponding myocardial segments (r = -0.55, p < 0.001). Patients with moderate to severe arterial stenosis exhibited a decreased LVEF compared to those with normal coronary arteries (48.0% vs 56.5%, p < 0.001).
CONCLUSION
Compared to conventional CCTA, our new developed ""one-stop"" CTP may provide more comprehensive information on myocardial perfusion, coronary artery stenosis, and LV cardiac function with reduced radiation and contrast medium doses.",2020,"Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2 =36.98, p < 0.001) were observed among four subgroups.",['442 patients with suspected coronary artery disease'],"['conventional CCTA', 'Low Radiation Dose in ""One-Stop"" Myocardial Computed Tomography Perfusion Imaging', 'conventional coronary CT angiography (CCTA', 'one-stop"" myocardial computed tomography perfusion (CTP) imaging (combined anatomy, perfusion, and function', 'one-stop"" CTP']","['transmural perfusion ratio (TPR) and left ventricular ejection fraction (LVEF', 'Scan time', 'degree of coronary artery stenosis and TPR of the corresponding myocardial segments', 'LVEF', 'minimum TPR', 'Image quality of CT images', 'image quality', 'severe arterial stenosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C2350393', 'cui_str': 'Perfusion Imaging'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0010734', 'cui_str': 'CRPPP'}]","[{'cui': 'C0522497', 'cui_str': 'Transmural (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0441633'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0242231', 'cui_str': 'Coronary Artery Stenosis'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0038449', 'cui_str': 'Stricture of artery (disorder)'}]",442.0,0.02102,"Significant differences regarding the minimum TPR (F = 24.657, p < 0.001) and LVEF (χ 2 =36.98, p < 0.001) were observed among four subgroups.","[{'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Kaiyue', 'Initials': 'K', 'LastName': 'Diao', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Sixian', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Jinge', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Wanlin', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Chunchao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China.'}, {'ForeName': 'Yingkun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Radiology, Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, West China Hospital, Sichuan University, No. 37 Guo Xue Alley, Wuhou District, Chengdu, Sichuan Province 610041, China. Electronic address: HX_lizhenlin@126.com.'}]",Academic radiology,['10.1016/j.acra.2019.11.018']
554,30079756,A Large Randomized Trial: Effects of Mindfulness-Based Stress Reduction (MBSR) for Breast Cancer (BC) Survivors on Salivary Cortisol and IL-6.,"Breast cancer survivors (BCS) often experience psychological and physiological symptoms after cancer treatment. Mindfulness-based stress reduction (MBSR), a complementary and alternative therapy, has reduced subjective measures of stress, anxiety, and fatigue among BCS. Little is known, however, about how MBSR affects objective markers of stress, specifically the stress hormone cortisol and the pro-inflammatory cytokine interleukin-6 (IL-6). In the present study, BCS ( N = 322) were randomly assigned to a 6-week MBSR program for BC or usual-care control. Measurements of cortisol, IL-6, symptoms, and quality of life were obtained at orientation and 6 weeks. Cortisol and IL-6 were also measured prior to and after the MBSR(BC) class Weeks 1 and 6. The mean age of participants was 56.6 years and 69.4% were White non-Hispanic. Most had Stage I (33.8%) or II (35.7%) BC, and 35.7% had received chemotherapy and radiation. Cortisol levels were reduced immediately following MBSR(BC) class compared to before the class Weeks 1 and 6 (Wilcoxon-signed rank test; p < .01, d = .52-.56). IL-6 was significantly reduced from pre- to postclass at Week 6 (Wilcoxon-signed rank test; p < .01, d = .21). No differences were observed between the MBSR(BC) and control groups from baseline to Week 6 using linear mixed models. Significant relationships with small effect sizes were observed between IL-6 and both symptoms and quality of life in both groups. Results support the use of MBSR(BC) to reduce salivary cortisol and IL-6 levels in the short term in BCS.",2019,No differences were observed between the MBSR(BC) and control groups from baseline to Week 6 using linear mixed models.,"['Breast cancer survivors (BCS', ' N = 322', 'The mean age of participants was 56.6 years and 69.4% were White non-Hispanic', 'Breast Cancer (BC) Survivors on Salivary Cortisol and IL-6']","['Mindfulness-based stress reduction (MBSR', 'MBSR program for BC or usual-care control', 'Mindfulness-Based Stress Reduction (MBSR', 'BCS']","['Cortisol levels', 'Measurements of cortisol, IL-6, symptoms, and quality of life', 'IL-6', 'IL-6 and both symptoms and quality of life', 'subjective measures of stress, anxiety, and fatigue among BCS', 'salivary cortisol and IL-6 levels', 'Cortisol and IL-6']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517712', 'cui_str': 'Three hundred and twenty-two'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",322.0,0.0201302,No differences were observed between the MBSR(BC) and control groups from baseline to Week 6 using linear mixed models.,"[{'ForeName': 'Cecile A', 'Initials': 'CA', 'LastName': 'Lengacher', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Reich', 'Affiliation': '2 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Carly L', 'Initials': 'CL', 'LastName': 'Paterson', 'Affiliation': '3 Patient-Centered Outcomes Research Institute, Washington, DC, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Shelton', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Shivers', 'Affiliation': '4 Department of Surgery, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Ramesar', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Pleasant', 'Affiliation': '5 Health Services Advisory Group, Tampa, FL, USA.'}, {'ForeName': 'Pinky', 'Initials': 'P', 'LastName': 'Budhrani-Shani', 'Affiliation': ""6 College of Nursing, Texas Woman's University, Houston, TX, USA.""}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Groer', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Post-White', 'Affiliation': '7 University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Versie', 'Initials': 'V', 'LastName': 'Johnson-Mallard', 'Affiliation': '8 College of Nursing, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Kane', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Lakeshia', 'Initials': 'L', 'LastName': 'Cousin', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Manolete S', 'Initials': 'MS', 'LastName': 'Moscoso', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Romershausen', 'Affiliation': '1 College of Nursing, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Jong Y', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': '2 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}]",Biological research for nursing,['10.1177/1099800418789777']
555,31321427,The effect of medication cost transparency alerts on prescriber behavior.,"OBJECTIVE
The purpose of this study was to determine if medication cost transparency alerts provided at time of prescribing led ambulatory prescribers to reduce their use of low-value medications.
MATERIALS AND METHODS
Provider-level alerts were deployed to ambulatory practices of a single health system from February 2018 through April 2018. Practice sites included 58 primary care and 152 specialty care clinics totaling 1896 attending physicians, residents, and advanced practice nurses throughout western Washington. Prescribers in the randomly assigned intervention arm received a computerized alert whenever they ordered a medication among 4 high-cost medication classes. For each class, a lower cost, equally effective, and safe alternative was available. The primary outcome was the change in prescribing volume for each of the 4 selected medication classes during the 12-week intervention period relative to a prior 24-week baseline.
RESULTS
A total of 15 456 prescriptions for high-cost medications were written during the baseline period including 7223 in the intervention arm and 8233 in the control arm. During the intervention period, a decrease in daily prescribing volume was noted for all high-cost medications including 33% for clobetasol propionate (p < .0001), 59% for doxycycline hyclate (p < .0001), 43% for fluoxetine tablets (p < .0001), and a non-significant 3% decrease for high-cost triptans (p = .65). Prescribing volume for the high-cost medications overall decreased by 32% (p < .0001).
CONCLUSION
Medication cost transparency alerts in an ambulatory setting lead to more cost-conscious prescribing. Future work is needed to predict which alerts will be most effective.",2019,"Prescribing volume for the high-cost medications overall decreased by 32% (p < .0001).
","['prescriber behavior', '58 primary care and 152 specialty care clinics totaling 1896 attending physicians, residents, and advanced practice nurses throughout western Washington', 'Provider-level alerts were deployed to ambulatory practices of a single health system from February 2018 through April 2018']","['doxycycline', 'computerized alert whenever they ordered a medication among 4 high-cost medication classes', 'fluoxetine']","['change in prescribing volume for each of the 4 selected medication classes', 'high-cost triptans', 'daily prescribing volume']","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0401999', 'cui_str': 'Practice nurse (occupation)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1567966', 'cui_str': 'Triptans'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",58.0,0.0200453,"Prescribing volume for the high-cost medications overall decreased by 32% (p < .0001).
","[{'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Monsen', 'Affiliation': 'Center for Analytics and Informatics, Atrius Health, Newton, Massachusetts, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Liao', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Gaster', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Flynn', 'Affiliation': 'Department of Pharmacy Services, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Payne', 'Affiliation': 'Department of Biomedical Informatics and Medical Education, University of Washington, Seattle, Washington, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz025']
556,31843026,Effects of suicide awareness materials on individuals with recent suicidal ideation or attempt: online randomised controlled trial.,"BACKGROUND
Awareness materials featuring ways of coping with suicidal ideation can reduce suicidal ideation, the so-called Papageno effect. All of the previous experimental studies on this subject have been conducted with individuals not at risk of suicide.
AIMS
To assess effects of suicide awareness materials in a sample of individuals with recent suicidal ideation. Trial registration: German Clinical Trial Registry ID number DRKS00013613.
METHOD
Adults (n = 266) with recent self-reported suicidal ideation or attempt were randomised to read an educative article featuring a lay individual with personal experience of suicidality (n = 86), a similar article featuring a mental health expert (n = 90), or an unrelated article (n = 90) in a double-blind online randomised controlled trial. Questionnaire data were collected before (T1) and immediately after exposure (T2) as well as 1 week later (study end-point, T3) and analysed with linear mixed models. The primary outcome was suicide risk as assessed using the Survival and Coping Beliefs subscale of the Reasons for Living Inventory (RFLI); secondary outcomes were suicide-prevention knowledge and mood.
RESULTS
There was an immediate beneficial effect on suicide risk in the intervention group exposed to the message delivered by the individual with personal experience (group 1) as compared with the control group that was maintained until the study end-point (study end-point: RFLI score mean difference from baseline within group 1 MD = -0.36 (95% CI -0.66 to -0.06), mean difference compared with control group MD = -0.71 (95% CI -1.27 to -0.14); d = -0.18). The effect was particularly pronounced for individuals with recent suicide attempt (RFLI score at T3, compared with control group: MD = -1.55 (95% CI -2.52 to -0.57); d = -0.23). Participants in this group also showed increased prevention-related knowledge compared with the control group.
CONCLUSIONS
Individuals with a recent suicide attempt appear to benefit from a printed narrative of positive coping with suicidal ideation. The intervention materials do not increase short-term suicide risk.",2020,"The effect was particularly pronounced for individuals with recent suicide attempt (RFLI score at T3, compared with control group: MD = -1.55","['individuals with recent suicidal ideation or attempt', 'individuals with recent suicidal ideation', 'Adults (n = 266) with recent self-reported suicidal ideation or attempt were randomised to read an educative article featuring a lay individual with personal experience of suicidality (n = 86), a similar article featuring a mental health expert (n = 90), or an unrelated article (n = 90']",['suicide awareness materials'],"['prevention-related knowledge', 'suicide risk', 'suicide risk as assessed using the Survival and Coping Beliefs subscale of the Reasons for Living Inventory (RFLI); secondary outcomes were suicide-prevention knowledge and mood', 'short-term suicide risk', 'Questionnaire data']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}]","[{'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.201036,"The effect was particularly pronounced for individuals with recent suicide attempt (RFLI score at T3, compared with control group: MD = -1.55","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Niederkrotenthaler', 'Affiliation': 'Unit Suicide Research & Mental Health Promotion, Department of Social and Preventive Medicine, Center for Public Health, Medical University of Vienna, Austria.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Till', 'Affiliation': 'Unit Suicide Research & Mental Health Promotion, Department of Social and Preventive Medicine, Center for Public Health, Medical University of Vienna, Austria.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.259']
557,31797987,Early life cognitive development trajectories and intelligence quotient in middle childhood and early adolescence in rural western China.,"The relationship of cognitive developmental trajectories during the dynamic first years with later life development outcomes remains unclear in low- and middle-income countries. 1388 Children born to women who participated in a randomized trial of antenatal micronutrient supplementation in rural China were prospectively followed. Cognitive development was assessed six times between 3 and 30 months of age using Bayley Scales of Infant Development, and then in mid-childhood (7-9 years) and early adolescence (10-12 years) using Wechsler Intelligence Scale for Children. We identified four distinct infant cognitive development trajectory subgroups using group-based trajectory modeling: (i) consistently above average, (ii) consistently average, (iii) started below average and then improved, and (iv) started below average and then declined. LBW infants (<2500 g) were 10.60 times (95% CI 3.57, 31.49) more likely to be in the trajectory group that started below average and then declined, while each grade increase in maternal education decreased the risk of being in this group by 73% (95% CI 54%, 84%). Infants who performed consistently above average had 8.02 (95% CI 1.46, 14.59) points higher IQ in adolescence versus the declining trajectory group. These findings suggest that interventions to improve early child development trajectories may produce long-term human capital benefits.",2019,"LBW infants (<2500 g) were 10.60 times (95% CI 3.57, 31.49) more likely to be in the trajectory group that started below average and then declined, while each grade increase in maternal education decreased the risk of being in this group by 73% (95% CI 54%, 84%).","['middle childhood and early adolescence in rural western China', '1388 Children born to women who participated']",['antenatal micronutrient supplementation'],"['Cognitive development', 'maternal education']","[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",1388.0,0.0300938,"LBW infants (<2500 g) were 10.60 times (95% CI 3.57, 31.49) more likely to be in the trajectory group that started below average and then declined, while each grade increase in maternal education decreased the risk of being in this group by 73% (95% CI 54%, 84%).","[{'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Suying', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': ""United Nations Children's Fund, China Office, Beijing, 100600, P.R. China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Nutrition and Food Safety Research, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Shaoru', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elhoumed', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi, 710061, P.R. China. tjzlx@mail.xjtu.edu.cn.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Scientific reports,['10.1038/s41598-019-54755-1']
558,31329828,"Safety, feasibility, and effect of an enhanced nutritional support pathway including extended preoperative and home enteral nutrition in patients undergoing enhanced recovery after esophagectomy: a pilot randomized clinical trial.","The aims of this pilot study are to evaluate the feasibility, safety, and effectiveness of conducting an enhanced nutritional support pathway including extended preoperative nutritional support and one month home enteral nutrition (HEN) for patients who underwent enhanced recovery after esophagectomy. We implemented extended preoperative nutritional support and one month HEN after discharge for patients randomized into an enhanced nutrition group and implemented standard nutritional support for patients randomized into a conventional nutrition group. Except the nutritional support program, both group patients underwent the same standardized enhanced recovery after surgery programs of esophagectomy based on published guidelines. Patients were assessed at preoperative day, postoperative day 7 (POD7), and POD30 for perioperative outcomes and nutritional status. To facilitate the determination of an effect size for subsequent appropriately powered randomized clinical trials and assess the effectiveness, the primary outcome we chose was the weight change before and after esophagectomy. Other outcomes including body mass index (BMI), lean body mass (LBM), appendicular skeletal muscle mass index (ASMI), nutrition-related complications, and quality of life (QoL) were also analyzed. The intention-to-treat analysis of the 50 randomized patients showed that there was no significant difference in baseline characteristics. The weight (-2.03 ± 2.28 kg vs. -4.05 ± 3.13 kg, P = 0.012), BMI (-0.73 ± 0.79 kg/m2 vs. -1.48 ± 1.11 kg/m2, P = 0.008), and ASMI (-1.10 ± 0.37 kg/m2 vs. -1.60 ± 0.66 kg/m2, P = 0.010) loss of patients in the enhanced nutrition group were obviously decreased compared to the conventional nutrition group at POD30. In particular, LBM (48.90 ± 9.69 kg vs. 41.96 ± 9.37 kg, p = 0.031) and ASMI (7.56 ± 1.07 kg/m2 vs. 6.50 ± 0.97 kg/m2, P = 0.003) in the enhanced nutrition group were significantly higher compared to the conventional nutrition group at POD30, despite no significant change between pre- and postoperation. In addition, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 scores revealed that enhanced nutritional support improved the QoL of patients in physical function (75.13 ± 9.72 vs. 68.33 ± 7.68, P = 0.009) and fatigue symptom (42.27 ± 9.93 vs. 49.07 ± 11.33, P = 0.028) compared to conventional nutritional support. This pilot study demonstrated that an enhanced nutritional support pathway including extended preoperative nutritional support and HEN was feasible, safe, and might be beneficial to patients who underwent enhanced recovery after esophagectomy. An appropriately powered trial is warranted to confirm the efficacy of this approach.",2020,"The weight (-2.03 ± 2.28 kg vs. -4.05 ± 3.13 kg, P = 0.012), BMI (-0.73 ± 0.79 kg/m2 vs. -1.48 ","['patients undergoing enhanced recovery after esophagectomy', 'patients who underwent enhanced recovery after esophagectomy']","['enhanced nutritional support pathway including extended preoperative nutritional support and one month home enteral nutrition (HEN', 'enhanced nutritional support pathway including extended preoperative and home enteral nutrition', 'enhanced nutrition group and implemented standard nutritional support', 'conventional nutrition group']","['Cancer Quality of Life Questionnaire', 'BMI', 'postoperative day 7 (POD7), and POD30 for perioperative outcomes and nutritional status', 'body mass index (BMI), lean body mass (LBM), appendicular skeletal muscle mass index (ASMI), nutrition-related complications, and quality of life (QoL', 'fatigue symptom', 'ASMI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}]",50.0,0.0493174,"The weight (-2.03 ± 2.28 kg vs. -4.05 ± 3.13 kg, P = 0.012), BMI (-0.73 ± 0.79 kg/m2 vs. -1.48 ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital, Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Diao', 'Affiliation': 'Department of Medical Imaging, Medical Imaging Center, Jinling Hospital.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Shao', 'Affiliation': 'Department of Cardiothoracic Surgery, Jingling Hospital, Jingling School of Clinical Medicine, Nanjing Medical University.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Key laboratory for Molecular Medicine, Medical school of Nanjing University.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital, Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Diao', 'Affiliation': 'Medical School, Southeast University, Nanjing.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Cong', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Qiang', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University.'}]",Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus,['10.1093/dote/doz030']
559,31756535,Anti-Thymocyte Globulin Prophylaxis Induces a Decrease in Naive Th Cells to Inhibit the Onset of Chronic Graft-versus-Host Disease: Results from the Canadian Bone Marrow Transplant Group (CBMTG) 0801 Study.,"Anti-thymocyte globulin (ATG) is an established approach to decrease chronic GVHD (cGVHD), yet the exact mechanism is uncertain. To better understand the mechanism of action of ATG in preventing cGVHD, we evaluated the day 100 immune reconstitution of known cGVHD cellular biomarkers using patients from the randomized Canadian Bone Marrow Transplant Group (CBMTG) 0801 trial, which demonstrated a significant impact of ATG on cGVHD. In a separate companion biology study, we evaluated the impact of ATG prophylaxis on cGVHD cellular markers at day 100 in 40 CBMTG 0801 patients. Analysis focused on previously identified cGVHD cellular biomarkers, including naive helper T (Th) cells, recent thymic emigrant (RTE) Th cells, CD21 low B cells, CD56 bright NK reg cells, and T reg cells ST2, osteopontin, soluble B-cell activating factor (sBAFF), Interleukin-2 receptor alpha (sCD25), T-cell immunoglobulin and mucin domain-3 (TIM-3), matrix metallopeptidase 3, ICAM-1, C-X-C motif chemokine 10 (CXCL10), and soluble aminopeptidase N. The ATG-treated group had a >10-fold decrease in both RTE naive Th and naive Th cells (P < .0001) and a 10-fold increase in CD56 bright NK reg cells (P < .0001). T reg cells, conventional Th cells, CD21 low B cells, and all plasma markers were not affected. In the populations most affected by ATG, changes in naive Th cells were associated with the later development of cGVHD. This analysis suggests that ATG primarily impacts on cGVHD through suppression of naive Th cell expansion after transplantation. These associations need to be validated in additional studies.",2020,"T reg cells, conventional Th cells, CD21 low B cells, and all plasma markers were not affected.",['at day 100 in 40 CBMTG 0801 patients'],['CD56 bright'],"['cGvHD cellular markers', 'T reg cells, conventional Th cells, CD21 low B cells, and all plasma markers', 'Th cells; c) CD21 low B cells', 'NK reg cells; e) T reg cells ST2, Osteopontin, sBAFF, sCD25, TIM-3, MMP3, ICAM-1, CXCL10, and soluble aminopeptidase N', 'RTE Naive Th and Naïve Th cells', 'Naïve helper T (Th) cells, b) recent thymic emigrant (RTE', 'CD56 bright NK reg cells']","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}]","[{'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0018894', 'cui_str': 'T-Lymphocytes, Helper'}, {'cui': 'C0056184', 'cui_str': 'Receptors, C3d'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0450499', 'cui_str': 'ST2 (body structure)'}, {'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0054943', 'cui_str': 'CD13 Antigens'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1955873', 'cui_str': 'Emigrants'}, {'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}]",801.0,0.10408,"T reg cells, conventional Th cells, CD21 low B cells, and all plasma markers were not affected.","[{'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Naeije', 'Affiliation': ""Division of Pediatric Hematology/Oncology/Blood & Marrow Transplant, BC Children's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Kariminia', 'Affiliation': ""Michael Cuccione Childhood Cancer Research Program, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Abdossamadi', 'Affiliation': ""Michael Cuccione Childhood Cancer Research Program, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Azadpour', 'Affiliation': 'Department of Hematology, Faculty of Medical Sciences, Tarbiat Modaress University, Tehran, Iran.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Subrt', 'Affiliation': ""Michael Cuccione Childhood Cancer Research Program, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Kuzeljevic', 'Affiliation': ""Clinical Research Support Unit, BC Children's Research, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Irvine', 'Affiliation': ""Clinical Research Support Unit, BC Children's Research, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Walker', 'Affiliation': 'McMaster University and Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Schultz', 'Affiliation': ""Division of Pediatric Hematology/Oncology/Blood & Marrow Transplant, BC Children's Hospital, Vancouver, British Columbia, Canada; Michael Cuccione Childhood Cancer Research Program, BC Children's Hospital Research Institute, Vancouver, British Columbia, Canada. Electronic address: kschultz@mail.ubc.ca.""}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.11.015']
560,31844364,Home-Based Extended Low-Dose Oral Misoprostol in Management of First-Trimester Pregnancy Loss in Low-Resource Communities: A Randomized Trial.,"Objective
To investigate the efficacy, safety and tolerability of a home-based extended low-dose oral misoprostol for management of first-trimester pregnancy loss.
Materials and Methods
A randomized trial that was conducted in the Woman's Health University Hospital and El-eman Maternity Hospital, Assiut, Egypt. One hundred and sixty patients were included. They were randomly assigned to receive four tablets of 200 μg misoprostol vaginally (max. 800 μg-hospital group) or 12 tablets orally, one every 3 h, over 2 consecutive days (max. 2400 μg-extended low-dose home group). For failed first dose, another similar second dose was given. Primary outcome measure was the percentage of patients with 'medically completed miscarriages' in each group (including complete miscarriages + incomplete miscarriages with successful post-miscarriage misoprostol).
Results
The total number of patients with 'medically completed miscarriages' in home group was 65/79 (82.3%), which was comparable to the hospital group (52/71 or 73.2%) ( P = 0.182). However, the majority of patients in home group had significantly successful miscarriages after a single course of low-dose oral misoprostol, experienced much less heavy bleeding attacks and had less systemic side effects.
Conclusion
In low-resource communities, the home-based extended low-dose oral misoprostol protocol proved high efficacy, safety and tolerability in management of first-trimester pregnancy loss.",2019,"In low-resource communities, the home-based extended low-dose oral misoprostol protocol proved high efficacy, safety and tolerability in management of first-trimester pregnancy loss.","['One hundred and sixty patients were included', 'Low-Resource Communities', ""Woman's Health University Hospital and El-eman Maternity Hospital, Assiut, Egypt""]","['home-based extended low-dose oral misoprostol', 'Home-Based Extended Low-Dose Oral Misoprostol', 'misoprostol']","['systemic side effects', ""total number of patients with 'medically completed miscarriages"", 'efficacy, safety and tolerability', 'complete miscarriages\u2009+\u2009incomplete miscarriages with successful post-miscarriage misoprostol', ""percentage of patients with 'medically completed miscarriages"", 'heavy bleeding attacks', 'successful miscarriages']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0080339', 'cui_str': 'Womens Health'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306041', 'cui_str': 'Complete miscarriage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000810', 'cui_str': 'Abortion, Incomplete'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}]",160.0,0.204924,"In low-resource communities, the home-based extended low-dose oral misoprostol protocol proved high efficacy, safety and tolerability in management of first-trimester pregnancy loss.","[{'ForeName': 'Ayman H', 'Initials': 'AH', 'LastName': 'Shaamash', 'Affiliation': ""1Department of Obstetrics and Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Assiut, 71116 Egypt.""}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Khlifah', 'Affiliation': ""1Department of Obstetrics and Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Assiut, 71116 Egypt.""}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Esmail', 'Affiliation': ""1Department of Obstetrics and Gynecology, Woman's Health Hospital, Faculty of Medicine, Assiut University, Assiut, 71116 Egypt.""}, {'ForeName': 'Sh G', 'Initials': 'SG', 'LastName': 'Abdelmonem', 'Affiliation': '2Department of Obstetrics and Gynecology, El eman Hospital, Ministry of Health, Assiut City, Egypt.'}]",Journal of obstetrics and gynaecology of India,['10.1007/s13224-019-01247-x']
561,31844371,Comparative Study of Neoadjuvant Chemotherapy Followed by Definitive Chemoradiotherapy Versus Definitive Chemoradiotherapy Alone in Locally Advanced Carcinoma of Cervix.,"Background
Carcinoma in the cervix is the most common malignancy and the fourth most common cause of death in females worldwide. It is the most common malignancy in India, the increasing incidence of cancer is escalating burden over radiation. This is a prospective randomized study comparing NACT followed by definitive chemoradiation versus chemoradiation.
Materials and Methods
This prospective randomized study analyzed 80 cervical cancer patients who were treated at our center during March 2017 and July 2018. Patients were divided into two arms: one received NACT and definitive CT/T and the other received definitive CT/RT. Statistical analysis was done using SPSS V.20 software.
Results
Overall response rate in our study was found to be 96.2%. In the study group, it was 97.5%, whereas in the control group, it was 95%. Majority of patients were in the age group 41-50 years, mainly stage IIb and IIIb. Tumor response in both the arms was similar and statistically significant (Chi 2 = 0.348; p > 0.05). The hematologic toxicities ( p > 0.05) were more in the NACT group than in the CCRT group, while gastrointestinal toxicities were slightly higher in the control (statistically insignificant).
Conclusion
NACT with taxane/platin followed by definitive CT/RT is as effective as the standard care in the treatment of locally advanced cervical cancer. It has even shown better results ( p value > .005) and is also helpful in reducing systemic micrometastasis and bulk of the disease. It can be used as an alternative to the standard care at the places of long waiting time for the definitive treatment, without compromising the outcome.",2019,"The hematologic toxicities ( p > 0.05) were more in the NACT group than in the CCRT group, while gastrointestinal toxicities were slightly higher in the control (statistically insignificant).
","['locally advanced cervical cancer', 'Majority of patients were in the age group 41-50 years, mainly stage IIb and IIIb', '80 cervical cancer patients who were treated at our center during March 2017 and July 2018', 'Locally Advanced Carcinoma of Cervix']","['Neoadjuvant Chemotherapy Followed by Definitive Chemoradiotherapy', 'NACT and definitive CT/T and the other received definitive CT/RT', 'CCRT', 'NACT with taxane/platin followed by definitive CT/RT', 'Definitive Chemoradiotherapy', 'NACT']","['Tumor response', 'Overall response rate', 'hematologic toxicities', 'gastrointestinal toxicities']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}]",80.0,0.0221107,"The hematologic toxicities ( p > 0.05) were more in the NACT group than in the CCRT group, while gastrointestinal toxicities were slightly higher in the control (statistically insignificant).
","[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Tripathi', 'Affiliation': 'Netaji Subhash Chandra Bose Medical College and Hospital, Jabalpur, India.'}, {'ForeName': 'Shyamji', 'Initials': 'S', 'LastName': 'Rawat', 'Affiliation': 'Netaji Subhash Chandra Bose Medical College and Hospital, Jabalpur, India.'}]",Journal of obstetrics and gynaecology of India,['10.1007/s13224-019-01236-0']
562,31925811,Clinical outcomes of the entire papilla preservation technique with and without biomaterials in the treatment of isolated intrabony defects: A randomized controlled clinical trial.,"AIM
This study compared the clinical efficacy of the entire papilla preservation technique (EPP) alone and in combination with enamel matrix proteins plus bovine-derived bone substitutes (EPP EMD + BS) in the treatment of isolated inter-dental intrabony defects.
MATERIAL AND METHODS
Thirty patients, each with one isolated intrabony defect, were randomly assigned to EPP EMD + BS or EPP alone. Clinical outcomes were assessed 1-year post-surgery.
RESULTS
Early healing phase was uneventful in all cases, and 100% primary wound closure was maintained throughout the study period. Intragroup differences between baseline and 1-year were statistically significant in both groups in terms of clinical attachment level (CAL) gain and probing depth (PD) reduction (p ≤ .001). No statistically significant differences were detected in gingival recession (REC) (p > .05). No statistically significant differences were detected in terms of CAL gain (6.3 ± 2.5 mm vs. 5.83 ± 1.12 mm), PD reduction (6.5 ± 2.65 mm vs. 6.2 ± 1.33 mm) or increase in gingival recession (0.2 ± 0.25 mm vs. 0.36 ± 0.54 mm) between the groups treated with EPP EMD + BS or EPP alone.
CONCLUSIONS
Application of EPP with and without regenerative biomaterials resulted in significant amounts of CAL gain and PD reduction, with negligible increase in gingival recession. Within the limits of the present study, it can be concluded that the addition of regenerative biomaterials does not improve the clinical outcomes of EPP alone. NCT03923465.",2020,No statistically significant differences were detected in gingival recession (REC) (p > .05).,"['isolated interdental intrabony defects', 'Thirty patients, each with one isolated intrabony defect', 'isolated intrabony defects']","['entire papilla preservation technique (EPP) alone and in combination with enamel matrix proteins plus bovine-derived bone substitutes (EPP EMD\xa0+\xa0BS', 'entire papilla preservation technique with and without biomaterials', 'EPP EMD\xa0+\xa0BS or EPP alone']","['CAL gain', 'gingival recession', 'gingival recession (REC', 'CAL gain and PD reduction', 'PD reduction', 'Early healing phase', 'clinical attachment level (CAL) gain and probing depth (PD) reduction']","[{'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0893442', 'cui_str': 'enamel matrix proteins'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}, {'cui': 'C0243003', 'cui_str': 'Bone Replacement Materials'}, {'cui': 'C0162568', 'cui_str': 'Erythropoietic Protoporphyrias'}, {'cui': 'C0340861', 'cui_str': 'PEA - Pulseless electrical activity'}, {'cui': 'C0005479', 'cui_str': 'Biomaterials'}]","[{'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0017572', 'cui_str': 'Gingival Recession'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",30.0,0.153634,No statistically significant differences were detected in gingival recession (REC) (p > .05).,"[{'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Aslan', 'Affiliation': 'Private Office Dr. Aslan, İzmir, Turkey.'}, {'ForeName': 'Nurcan', 'Initials': 'N', 'LastName': 'Buduneli', 'Affiliation': 'Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Cortellini', 'Affiliation': 'Accademia Toscana di Ricerca Odontostomatologica (ATRO), Florence, Italy.'}]",Journal of clinical periodontology,['10.1111/jcpe.13255']
563,31912523,Clinical and radiographic changes at tissue level implants with either a machined or a modified transmucosal neck surface: A 3-year multicentre randomized controlled proof-of-concept study.,"BACKGROUND
Surface modification may yield enhanced soft tissue adhesion to transmucosal titanium implant necks.
AIM
To evaluate and compare changes in soft tissues around implants with a modified hydrophilic sandblasted and acid-etched neck (mSLA; test) to those with a machined neck (M; control).
MATERIALS AND METHODS
Implants with a diameter of 4.1 mm and a neck height of 1.8 mm were randomly inserted in healed sites with pristine bone of the posterior maxilla or mandible. The modified Sulcus Bleeding Index (mSBI) (primary outcome) was assessed at baseline (BL) and 6, 12 and 36 months. Secondary outcomes included the assessment of pocket probing depth (PPD), mucosal recession (REC) and clinical attachment level (CAL). Standardized radiographs were taken at time of implant placement, at BL and after 12 and 36 months.
RESULTS
Of the 43 randomized subjects, 38 (19 test and 19 controls) completed the 36-month follow-up. Implant survival rates amounted to 95.5% (test) and 100% (control) (p > .05). At 36 months, 77.6% of test implants and 78.9% of control implants were without any bleeding sites (mSBI = 0; p > .05). The 36-month success rate was 86.4% in the test and 85.7% in the control group, respectively (p > .05). At 36 months, the mean radiographic bone level change from BL was 0.33 ± 0.69 mm at test implants and 0.12 ± 0.3 mm at control implants (p > .05).
CONCLUSION
Tissue level implants with a hydrophilic mSLA transmucosal neck failed to yield clinical and radiographic benefits compared with implants with a machined neck up to 3 years.",2020,Implant survival rates amounted to 95.5% (test) and 100% (control) (p > .05).,"['43 randomized subjects, 38 (19 test and 19 controls) completed the 36-month follow-up', 'Implants with a diameter of 4.1\xa0mm and a neck height of 1.8\xa0mm were randomly inserted in healed sites with pristine bone of the posterior maxilla or mandible']",['modified hydrophilic sandblasted and acid-etched neck (mSLA; test'],"['bleeding sites', 'assessment of pocket probing depth (PPD), mucosal recession (REC) and clinical attachment level (CAL', 'Implant survival rates', 'mean radiographic bone level change from BL', '36-month success rate', 'modified Sulcus Bleeding Index (mSBI']","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4278344', 'cui_str': 'Pristine (fungicide)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}]","[{'cui': 'C0475370', 'cui_str': 'Hydrophilicity'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0786766,Implant survival rates amounted to 95.5% (test) and 100% (control) (p > .05).,"[{'ForeName': 'Giovanni E', 'Initials': 'GE', 'LastName': 'Salvi', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Raphaël', 'Initials': 'R', 'LastName': 'Moëne', 'Affiliation': 'Division of Periodontology, School of Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Wallkamm', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Hicklin', 'Affiliation': 'Division of Fixed Prosthodontics and Biomaterials, School of Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bischof', 'Affiliation': 'Swiss Dental Clinics Group, Ardentis Clinique Dentaire, Lausanne, Switzerland.'}, {'ForeName': 'Rabah', 'Initials': 'R', 'LastName': 'Nedir', 'Affiliation': 'Swiss Dental Clinics Group, Ardentis Clinique Dentaire, Lausanne, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mombelli', 'Affiliation': 'Division of Periodontology, School of Dental Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Sculean', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}]",Journal of clinical periodontology,['10.1111/jcpe.13249']
564,31912532,Injectable platelet-rich fibrin and microneedling for gingival augmentation in thin periodontal phenotype: A randomized controlled clinical trial.,"AIM
The aim of this present study was to evaluate the effect of gingival thickness (GT) and keratinized tissue width (KTW) using injectable platelet-rich fibrin (i-PRF) alone and with microneedling (MN) in individuals with thin periodontal phenotypes.
MATERIALS AND METHODS
In this split-mouth study, 33 systemically healthy patients with thin periodontal phenotypes were randomly treated with MN + i-PRF and i-PRF. I-PRF was injected on one side, and MN + i-PRF was performed on the other side of the same patient at 4 sessions with 10-day intervals. Clinical periodontal measurements, GT and KTW were assessed before the treatment and every month for six months after the final injection.
RESULTS
After the evaluation of GT between the groups, a statistically significant difference was found in MN + i-PRF group at the sixth month. In the intra-group comparisons, a statistically significant increase in GT was observed within both i-PRF [from 0.43 mm ± 0.14 to 0.62 mm ± 0.11 (p < .001)] and MN + i-PRF [from 0.4 mm ± 0.14 to 0.66 mm ± 0.12 (p < .001)] groups at the sixth month.
CONCLUSIONS
In individuals with thin periodontal phenotypes, standalone i-PRF and i-PRF with MN may have an influence in increasing GT. The results suggest that application of i-PRF and MN may be a first step of non-surgical method for increasing gingival thickness.",2020,"After the evaluation of GT between the groups, a statistically significant difference was found in MN + i-PRF group at the sixth month.","['33 systemically healthy patients with thin periodontal phenotypes', 'individuals with thin periodontal phenotypes']","['gingival thickness(GT) and keratinized tissue width(KTW)\xa0using injectable-platelet rich fibrin(i-PRF) alone and with microneedling(MN', 'Injectable platelet-rich fibrin and microneedling for gingival augmentation', 'MN\xa0+\xa0i-PRF and i-PRF']","['Clinical periodontal measurements, GT, and KTW', 'GT', 'gingival thickness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}]",,0.0333933,"After the evaluation of GT between the groups, a statistically significant difference was found in MN + i-PRF group at the sixth month.","[{'ForeName': 'Zeliha Betul', 'Initials': 'ZB', 'LastName': 'Ozsagir', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Saglam', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, University of Health Science, Istanbul, Turkey.'}, {'ForeName': 'Berza', 'Initials': 'B', 'LastName': 'Sen Yilmaz', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Bezmialem University, Istanbul, Turkey.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Choukroun', 'Affiliation': 'FORM, Frankfurt Oral Regenerative Medicine, Clinic for Maxillofacial and Plastic Surgery, Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Tunali', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Bezmialem Vakif University, Istanbul, Turkey.'}]",Journal of clinical periodontology,['10.1111/jcpe.13247']
565,32161366,Oxytocin induces long-lasting adaptations within amygdala circuitry in autism: a treatment-mechanism study with randomized placebo-controlled design.,"Intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly explored as a potential treatment for targeting the core symptoms of autism spectrum disorder (ASD). To date, however, the impact of multiple-dose IN-OT treatment on human neural circuitry is largely unknown, and also the possibility that long-term IN-OT use may induce long-lasting neural adaptations remains unexplored. Using a double-blind, randomized, placebo-controlled, between-subject design (including 38 adult men with ASD), this treatment-mechanism study showed that 4 weeks of daily oxytocin administration (24 IU/day) significantly altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus) up to 4 weeks and 1 year post treatment. The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors. These observations contribute to a deeper mechanistic understanding of the neural substrates that underlie behavioral effects of multiple-dose IN-OT treatment, and provide initial insights into the long-lasting neural consequences of chronic IN-OT use on amygdala circuitry. Future studies are however warranted to further elucidate the long-term impact of IN-OT treatment on human neural circuitry and its behavioral consequences.",2020,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"['38 adult men with ASD', 'autism']","['neuropeptide oxytocin (IN-OT', 'oxytocin', 'Oxytocin', 'placebo']","['altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0228237', 'cui_str': 'Structure of superior temporal sulcus'}]",38.0,0.130252,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"[{'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium. Kaat.Alaerts@kuleuven.be.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bernaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jellina', 'Initials': 'J', 'LastName': 'Prinsen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dillen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Steyaert', 'Affiliation': 'Department of Neurosciences, Group Biomedical Sciences, Psychiatry Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wenderoth', 'Affiliation': 'Department of Health Sciences and Technology, Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0653-8']
566,31801937,Effects of intranasal oxytocin administration on empathy and approach motivation in women with borderline personality disorder: a randomized controlled trial.,"Borderline personality disorder (BPD) is characterized by severe interpersonal dysfunction with problems in social cognition, empathy and social approach. Although the neuropeptide oxytocin is known to regulate complex social cognition and behavior in healthy individuals and clinical populations, there is still a lack of evidence for a potential beneficial effect of oxytocin administration on social cognition and social approach in BPD. Fifty-one women with BPD and 51 matched healthy controls were randomized to a double-blind, placebo-controlled, between-subject experimental trial. We administered a single dose of 24 IU oxytocin or placebo intranasally prior to a standardized task measuring affective and cognitive empathy and approach motivation. All participants were free of hormonal contraception and tested in the mid-luteal phase of their menstrual cycle. In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls. Intranasal oxytocin significantly increased affective empathy and approach motivation in both BPD patients and healthy controls compared to placebo. More importantly, oxytocin administration led to similar scores between BPD and healthy controls. These findings provide the first evidence for a beneficial effect of oxytocin on deficits in affective empathy and approach motivation of BPD. Our results indicate a beneficial effect of a single dose of oxytocin on affective empathy and approach motivation in women with BPD adapting their level of social functioning to healthy controls. Future clinical trials will need to investigate the long-term effects and effectiveness of oxytocin as an add-on treatment for social impairments in BPD.",2019,"In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls.","['women with BPD adapting their level of social functioning to healthy controls', 'Fifty-one women with BPD and 51 matched healthy controls', 'healthy individuals and clinical populations', 'Borderline personality disorder (BPD', 'women with borderline personality disorder', 'All participants were free of hormonal contraception and tested in the mid-luteal phase of their menstrual cycle']","['oxytocin', 'placebo', 'Intranasal oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin', 'oxytocin or placebo']","['reduced cognitive and affective empathy', 'approach behavior motivation', 'affective empathy and approach motivation', 'empathy and approach motivation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0024153', 'cui_str': 'Postovulatory Phase'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C4046027', 'cui_str': 'Approach Behavior'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",51.0,0.175967,"In the placebo condition, patients with BPD showed reduced cognitive and affective empathy, and less approach behavior motivation than healthy controls.","[{'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Domes', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany. domes@uni-trier.de.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Ower', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'von Dawans', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': 'Department of Psychology, Clinical Psychology of Social Interaction, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bohus', 'Affiliation': 'Institute of Psychosomatic and Psychiatric Psychotherapy, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heinrichs', 'Affiliation': 'Department of Psychology, Laboratory for Biological and Personality Psychology, University of Freiburg, Freiburg, Germany. heinrichs@psychologie.uni-freiburg.de.'}]",Translational psychiatry,['10.1038/s41398-019-0658-4']
567,31307674,Role of posterior auricular muscle to prevent protruding ear after retroauricular ear surgery.,"OBJECTIVE
The posterior auricular muscle (PAM) functions in ear projection in normal position and is severed during the retroauricular approach, and some patients complain of a protruding ear postoperatively. This study was designed to determine whether suturing of the severed PAM reduces pinna projection after the retroauricular approach.
METHODS
In a prospective controlled study, we enrolled 91 patients with chronic otitis media, all of who underwent canal wall up mastoidectomy with tympanoplasty via retroauricular approach. They were randomly assigned to the PAM-sutured (n=45) or PAM-non-sutured (n=46) group. Helical-mastoid distance and concho-mastoid angle were measured serially.
RESULTS
In both groups, helical-mastoid distance was significantly longer than preoperatively until 1 month postoperatively but was similar to preoperatively by 6 months. Concho-mastoid angle increased significantly until 1 month after surgery in the PAM-non-sutured group but returned to the preoperative value at 6 months postoperatively. In the PAM-sutured group, concho-mastoid angle increased significantly at 3 days postoperatively, was similar to preoperatively at 1 month after surgery, and became narrower than preoperatively at 6 months postoperatively. In both groups, there were significant effects of time on the changes in helical-mastoid distance or concho-mastoid angle. Group assignment did not significantly affect these time-related changes.
CONCLUSION
PAM suturing did not affect helical-mastoid distance by 6 months postoperatively, but it did reduce the concho-mastoid angle to below the preoperative value at 6 months. We recommend that PAM be left severed to maintain concho-mastoid angle in the long term when using the retroauricular approach.",2020,"In the PAM-sutured group, concho-mastoid angle increased significantly at 3 days postoperatively, was similar to preoperatively at 1 month after surgery, and became narrower than preoperatively at 6 months postoperatively.","['91 patients with chronic otitis media, all of who underwent canal wall up mastoidectomy with tympanoplasty via retroauricular approach']","['PAM-sutured (n=45) or PAM-non-sutured', 'PAM suturing', 'posterior auricular muscle to prevent protruding ear after retroauricular ear surgery']","['time-related changes', 'Concho-mastoid angle', 'Helical-mastoid distance and concho-mastoid angle', 'helical-mastoid distance or concho-mastoid angle', 'concho-mastoid angle', 'helical-mastoid distance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271441', 'cui_str': 'Chronic otitis media (disorder)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0198154', 'cui_str': 'Mastoidectomy'}, {'cui': 'C0041447', 'cui_str': 'Tympanoplasty'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0446908', 'cui_str': 'Mastoid Bone'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",91.0,0.0524506,"In the PAM-sutured group, concho-mastoid angle increased significantly at 3 days postoperatively, was similar to preoperatively at 1 month after surgery, and became narrower than preoperatively at 6 months postoperatively.","[{'ForeName': 'Jong Cheol', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Tae-Uk', 'Initials': 'TU', 'LastName': 'Cheon', 'Affiliation': 'Department of Otorhinolaryngology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Jung On', 'Initials': 'JO', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Dan Bi', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Department of Otorhinolaryngology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Joong Keun', 'Initials': 'JK', 'LastName': 'Kwon', 'Affiliation': 'Department of Otorhinolaryngology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea. Electronic address: kwonjk@live.co.kr.'}]","Auris, nasus, larynx",['10.1016/j.anl.2019.06.006']
568,31284323,No Difference in Recovery of Patient-Reported Outcome and Range of Motion between Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty: A Double-Blind Randomized Controlled Trial.,"Both from the perspective of the individual and from a socioeconomic point of view (e.g., return to work), it is important to have an insight into the potential differences in recovery between posterior cruciate ligament retaining (PCR) and posterior stabilized (PS) total knee arthroplasty (TKA) implants. The primary aim of this study was to compare the speed of recovery of patient-reported outcome between patients with a PCR and PS TKA during the first postoperative year. The secondary aim was to compare the effect on range of motion (ROM). In a randomized, double-blind, controlled, single-center trial, 120 adults diagnosed with osteoarthritis of the knee were randomized into either the PCR or PS group. Primary outcome was speed of recovery of patient-reported pain and function, measured with the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), with a follow-up of 1 year. Main secondary outcome measure was ROM. A generalized estimating equations (GEE) analysis was used to assess whether there was a difference over time between groups ("" p -value for interaction""). Between 2008 and 2011, 59 participants received a PCR TKA (mean age, 70.3 years [SD = 7.7]; mean body mass index [BMI], 30.5 kg/m 2 [SD = 5.4]) and 55 participants a PS TKA (mean age, 73.5 years [SD = 7.0]; mean BMI, 29.2 kg/m 2 [SD = 4.4]). Six patients (two PCR and four PS) were excluded because of early drop-out, so 114 patients (95%) were available for analysis. In between group difference for total WOMAC score was -1.3 (95% confidence interval [CI]: -5.6 to 3.1); p -value for interaction was 0.698. For ROM, in between group difference was 1.1 (95% CI: -2.6 to 4.7); p -value for interaction was 0.379. These results demonstrated that there are no differences in speed of recovery of WOMAC or ROM during the first postoperative year after PCR or PS TKA.",2020,In between group difference for total WOMAC score was -1.3,"['120 adults diagnosed with osteoarthritis of the knee', 'patients with a PCR and PS TKA during the first postoperative year', 'Between 2008 and 2011, 59 participants received a', 'mean age, 70.3 years [SD\u2009=\u20097.7]; mean body mass index [BMI], 30.5\u2009kg/m 2 [SD\u2009=\u20095.4]) and 55 participants a PS TKA (mean age, 73.5 years [SD\u2009=\u20097.0]; mean BMI, 29.2\u2009kg/m 2 [SD\u2009=\u20094.4']","['PCR or PS', 'PCR TKA ']","['total WOMAC score', 'speed of recovery of WOMAC or ROM', 'speed of recovery of patient-reported pain and function, measured with the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), with a follow-up of 1\u2009year', 'ROM', 'Recovery of Patient-Reported Outcome and Range of Motion between Cruciate Retaining and Posterior Stabilized Total Knee Arthroplasty', 'range of motion (ROM']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C4517761', 'cui_str': '4.4'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]",120.0,0.683777,In between group difference for total WOMAC score was -1.3,"[{'ForeName': 'Lennard G H', 'Initials': 'LGH', 'LastName': 'van den Boom', 'Affiliation': 'Department of Orthopaedic Surgery, ETZ Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Reinoud W', 'Initials': 'RW', 'LastName': 'Brouwer', 'Affiliation': 'Department of Orthopaedic Surgery, Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'van den Akker-Scheek', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Inge H F', 'Initials': 'IHF', 'LastName': 'Reininga', 'Affiliation': 'Department of Trauma Surgery, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Astrid J', 'Initials': 'AJ', 'LastName': 'de Vries', 'Affiliation': 'Department of Orthopaedic Surgery, Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Sita M A', 'Initials': 'SMA', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Department of Orthopaedic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Jos J A M', 'Initials': 'JJAM', 'LastName': 'van Raay', 'Affiliation': 'Department of Orthopaedic Surgery, Martini Hospital, Groningen, the Netherlands.'}]",The journal of knee surgery,['10.1055/s-0039-1693023']
569,31259755,A Prospective Randomized Trial Comparing Topical Intranasal Lidocaine and Levobupivacaine in Patients Undergoing Endoscopic Binostril Transnasal Transsphenoidal Resection of Pituitary Tumors.,"INTRODUCTION
Local anesthetic intranasal packing is used in transnasal surgery to reduce hemodynamic fluctuations. We hypothesized that the long acting local anesthetic levobupivacaine would provide superior hemodynamic stability and postoperative analgesia compared with lidocaine in endoscopic transnasal transsphenoidal (TNTS) surgery.
MATERIALS AND METHODS
In this prospective, randomized, double-blind trial, 48 patients undergoing TNTS surgery were allocated to the 2 groups to receive preoperative intranasal packing with 15 mL of 1.5% lidocaine or 0.5% levobupivacaine each mixed with 60 mg ephedrine. Heart rate and mean arterial blood pressure were recorded immediately before induction of anesthesia, at various time points throughout surgery, and at tracheal extubation. Bleeding in the surgical field, time to extubation, and postoperative pain were also assessed.
RESULTS
There was no significant difference in heart rate between the lidocaine and levobupivacaine groups at any point. Mean arterial pressure was also similar between the 2 groups during surgery, whereas at extubation blood pressure was lower in the lidocaine compared with levobupivacaine group (85±10 vs. 96±16 mm Hg; P=0.0010). There were no differences between the 2 groups in the other outcome variables.
CONCLUSIONS
Preoperative intranasal packing with 1.5% lidocaine or 0.5% levobupivacaine provide similar hemodynamic stability throughout TNTS. Lidocaine packing may be more advantageous for hemodynamic stability during extubation.",2021,There was no significant difference in heart rate between the lidocaine and levobupivacaine groups at any point.,"['Patients Undergoing Endoscopic Binostril', '48 patients undergoing TNTS surgery']","['Lidocaine', 'lidocaine', 'levobupivacaine', 'Transnasal Transsphenoidal Resection of Pituitary Tumors', 'endoscopic transnasal transsphenoidal (TNTS) surgery', 'Topical Intranasal Lidocaine and Levobupivacaine', 'preoperative intranasal packing with 15\u2009mL of 1.5% lidocaine or 0.5% levobupivacaine each mixed with 60\u2009mg ephedrine']","['heart rate', 'Bleeding in the surgical field, time to extubation, and postoperative pain', 'Heart rate and mean arterial blood pressure', 'extubation blood pressure', 'Mean arterial pressure', 'hemodynamic stability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041070', 'cui_str': '2,4,6-Trinitrotoluene'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach (qualifier value)'}, {'cui': 'C0205508', 'cui_str': 'Transsphenoidal approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0032019', 'cui_str': 'Pituitary Tumors'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0014479', 'cui_str': 'Ephedrine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",48.0,0.0971222,There was no significant difference in heart rate between the lidocaine and levobupivacaine groups at any point.,"[{'ForeName': 'Arun S', 'Initials': 'AS', 'LastName': 'Konay', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Ari G', 'Initials': 'AG', 'LastName': 'Chacko', 'Affiliation': 'Department of Neurosurgery, Christian Medical College, Vellore, Tamil Nadu, India.'}, {'ForeName': 'Georgene', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Anesthesiology.'}]",Journal of neurosurgical anesthesiology,['10.1097/ANA.0000000000000619']
570,31267292,The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder.,"Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that reduces obsessive-compulsive symptoms. There is limited evidence supporting its efficacy for repetitive behaviors (RRBs) in autistic spectrum disorder (ASD). We conducted a randomized controlled trial (RCT) of fluoxetine in 158 individuals with ASD (5-17 years). Following 14 treatment weeks (mean dose 11.8 mg/day), no significant differences were noted on the Children's Yale-Brown Obsessive Compulsive Scale; the proportion of responders was similar (fluoxetine: 36%; placebo: 41%). There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%). Overly cautious dosing/duration may have prevented attainment of a therapeutic level. Results are consistent with other SSRI RCTs treating RRBs in ASD.Trial Registration: clinicaltrials.gov Identifier: NCT00515320.",2020,"There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%).","['Children and Adolescents with Autistic Disorder', 'autistic spectrum disorder (ASD', '158 individuals with ASD (5-17\xa0years']","['fluoxetine', 'placebo', 'Fluoxetine']","[""Children's Yale-Brown Obsessive Compulsive Scale"", 'rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation', 'Repetitive Behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",158.0,0.165503,"There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Herscu', 'Affiliation': 'Herscu Laboratory& Consulting, LLC, 356 Middle Street, Amherst, MA, USA.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Handen', 'Affiliation': 'School of Medicine, University of Pittsburgh, 1011 Bingham Street, Pittsburgh, PA, 15203, USA. handenbl@upmc.edu.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Nisonger Center - UCEDD,The Ohio State University, McCampbell Hall, 1581 Dodd Drive, Columbus, OH, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Snape', 'Affiliation': 'Neuropharm PLC, London, UK.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Bregman', 'Affiliation': 'Center for Autism and Neurodevelopmental Disorders, United Community and Family Services Healthcare, 47 Town Street, Norwich, CT, 06360, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Ginsberg', 'Affiliation': 'Red Oak Psychiatry Associates, 15115 Red Oak Drive #109, Houston, TX, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hendren', 'Affiliation': 'University of California, San Francisco, 401 Parnassus Ave, Box 0984, San Francisco, CA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, Seaver Autism Center for Research and Treatment, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1230, New York, NY, USA.'}, {'ForeName': 'Raun', 'Initials': 'R', 'LastName': 'Melmed', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mintz', 'Affiliation': 'The Center for Neurological and Neurodevelopmental Health and the Clinical Research Center of New Jersey, 2050 Voorhees Town Center, Voorhees, NJ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Minshew', 'Affiliation': ""School of Medicine, University of Pittsburgh, 3811 O'Hara St, Pittsburgh, PA, USA.""}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Duke Center for Autism and Brain Development, Duke University Medical School, 2608 Erwin Rd, Suite 300, Durham, NC, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Attalla', 'Affiliation': 'Institute for Behavioral Medicine, 696 Concord Road SE, Smyrna, GA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'King', 'Affiliation': 'UCSF Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Ave., Suite LP 358, San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Owley', 'Affiliation': 'University of Illinois at Chicago College of Medicine, 1835\xa0W Polk St, Chicago, IL, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine, Inc, 7351 Prairie Falcon Road, Suite 160, Las Vegas, NV, 89128, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Chugani', 'Affiliation': 'NYU Langone Comprehensive Epilepsy Center, 223 East 34th Street, New York, NY, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Frazier', 'Affiliation': 'University of Massachusetts Medical Center, 55 Lake Ave., North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cartwright', 'Affiliation': 'Spectrum Health Associates, 210 Bellevue Ave, Upper Montclair, NJ, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Murphy', 'Affiliation': 'University of South Florida Rothman Center for Pediatric Neuropsychiatry, 880 6th St South St., Petersburg, FL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04120-y']
571,31315150,A pilot randomized controlled trial of a gratitude intervention for adolescents with Type 1 diabetes.,"AIM
Cost-effective psychosocial interventions that can feasibly be implemented into busy clinical settings are needed to improve psychological and physical health outcomes in adolescents with Type 1 diabetes. We examined the efficacy of a gratitude journalling intervention to improve psychological well-being and glycaemic control in adolescents aged 10-16 years with Type 1 diabetes.
METHODS
Eighty adolescents were randomized to the 8-week gratitude intervention (N = 40) or standard care (N = 40). Self-reported measures of stress, quality of life, self-care, depression and gratitude were assessed at baseline and 8 weeks after baseline. Glycaemic control (HbA 1c ) was assessed at baseline and 12 weeks after baseline. A per-protocol analysis was conducted with the adolescents who completed all questionnaires (N = 60). Analysis of covariance (ANCOVA) was used to examine differences between treatment arms at follow-up adjusting for baseline scores.
RESULTS
There was no evidence of any between-group differences in the psychological or behavioural measures at follow-up (all P-values > 0.05). Glycaemic control slightly increased in the control group while remaining stable in the gratitude group, with a between-group difference of 6.1 mmol/mol [95% confidence interval (CI) -2.6 to 14.7; 0.6%, 95% CI -0.2 to 1.3] at 12 weeks after baseline. After adjusting for baseline HbA 1c , this between-group difference was significant (P = 0.048).
CONCLUSIONS
This is the first randomized trial of a gratitude journalling intervention for adolescents with Type 1 diabetes. Gratitude journalling interventions represent a clinically usable approach. If and how it helps to stabilise glycaemic control in adolescents with Type 1 diabetes remains to be confirmed in future research.",2020,There was no evidence of any between-group differences in the psychological or behavioural measures at follow-up (all P-values > 0.05).,"['Eighty adolescents', 'adolescents with Type 1 diabetes', 'adolescents aged 10-16 years with Type 1 diabetes']","['gratitude intervention', 'gratitude journalling intervention', 'gratitude intervention (N\xa0=\xa040) or standard care']","['Glycaemic control slightly', 'stress, quality of life, self-care, depression and gratitude', 'psychological or behavioural measures', 'Glycaemic control (HbA 1c ']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034380'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",80.0,0.0876569,There was no evidence of any between-group differences in the psychological or behavioural measures at follow-up (all P-values > 0.05).,"[{'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14078']
572,29986592,"Enrollment Strategies, Barriers to Participation, and Reach of a Workplace Intervention Targeting Sedentary Behavior.","PURPOSE
To review enrollment strategies, participation barriers, and program reach of a large, 2-year workplace intervention targeting sedentary behavior.
APPROACH
Cross-sectional, retrospective review.
SETTING
Twenty-four worksites balanced across academic, industry, and government sectors in Minneapolis/Saint Paul (Minnesota) and Phoenix (Arizona) regions.
PARTICIPANTS
Full-time (≥30+ h/wk), sedentary office workers.
METHODS
Reach was calculated as the proportion of eligible employees who enrolled in the intervention ([N enrolled/(proportion of eligible employees × N total employees)] × 100). Mean (1 standard deviation) and median worksite sizes were calculated at each enrollment step. Participation barriers and modifications were recorded by the research team. A survey was sent to a subset of nonparticipants (N = 57), and thematic analyses were conducted to examine reasons for nonparticipation, positive impacts, and negative experiences.
RESULTS
Employer reach was 65% (56 worksites invited to participate; 66% eligible of 56 responses; 24 enrolled). Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled). Postrandomization, on average, 59% (15%) of the worksites participated. Eighteen modifications were developed to overcome participant-, context-, and research-related participation barriers.
CONCLUSION
A high proportion of worksites and employees approached to participate in a sedentary behavior reduction intervention engaged in the study. Interventions that provide flexible enrollment, graded participant engagement options, and adopt a participant-centered approach may facilitate workplace intervention success.",2019,"Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled).","['Reach was calculated as the proportion of eligible employees who enrolled in the intervention ([N enrolled/(proportion of eligible employees × N total employees', 'Twenty-four worksites balanced across academic, industry, and government sectors in Minneapolis/Saint Paul (Minnesota) and Phoenix (Arizona) regions', 'Employer reach was 65% (56 worksites invited to participate; 66% eligible of 56 responses; 24 enrolled', 'Full-time (≥30+ h/wk), sedentary office workers', 'Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled']",[],['Mean (1 standard deviation) and median worksite sizes'],"[{'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",632.0,0.023983,"Employee reach was 58% (1317 invited to participate, 83% eligible of 906 responses; 632 enrolled).","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mullane', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Rydell', 'Affiliation': '2 Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Miranda L', 'Initials': 'ML', 'LastName': 'Larouche', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Meynard John L', 'Initials': 'MJL', 'LastName': 'Toledo', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Feltes', 'Affiliation': '3 Minnesota Department of Health, Saint Paul, MN, USA.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'Vuong', 'Affiliation': '4 Fairview Health Services, Saint Paul, MN, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': '5 Graduate School of Public Health, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Glenn A', 'Initials': 'GA', 'LastName': 'Gaesser', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Estabrooks', 'Affiliation': '6 College of Public Health, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Pereira', 'Affiliation': '2 Division of Epidemiology and Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Buman', 'Affiliation': '1 School of Nutrition and Health Promotion, Arizona State University, Tempe, AZ, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117118784228']
573,31804398,Five Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.,"OBJECTIVE
To determine whether absorbable or nonabsorbable mesh repair of large hiatus hernias is followed by less recurrences at late follow-up compared to sutured repair.
SUMMARY OF BACKGROUND DATA
Radiological recurrences have been reported in up to 30% of patients after repair of large hiatus hernias, and mesh repair has been proposed as a solution. Earlier trials have revealed mixed outcomes and early outcomes from a trial reported previously revealed no short-term advantages for mesh repair.
METHODS
Multicentre prospective double-blind randomized controlled trial of 3 methods of hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh. Primary outcome - hernia recurrence assessed by barium meal X-ray and endoscopy at 3-4 years. Secondary outcomes - clinical symptom scores at 2, 3, and 5 years.
RESULTS
126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh. Clinical outcomes were obtained at 5 years in 89.9%, and objective follow-up was obtained in 72.3%. A recurrent hernia (any size) was identified in 39.3% after suture repair, 56.7% - absorbable mesh, and 42.9% - nonabsorbable mesh (P = 0.371). Clinical outcomes were similar at 5 years, except chest pain, diarrhea, and bloat symptoms which were more common after repair with absorbable mesh.
CONCLUSIONS
No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh. The longer-term results from this trial do not support mesh repair for large hiatus hernias.",2019,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","['126 patients were enrolled - 43 sutures, 41 absorbable mesh, and 42 nonabsorbable mesh']","['Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh', 'hiatus hernia repair; sutures versus absorbable mesh versus nonabsorbable mesh', 'absorbable or nonabsorbable mesh repair']","['clinical symptom scores at 2, 3, and 5 years', 'recurrent hernia', 'chest pain, diarrhea, and bloat symptoms', 'hernia recurrence assessed by barium meal X-ray and endoscopy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}]","[{'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0450093', 'cui_str': 'Very large (qualifier value)'}, {'cui': 'C3489393', 'cui_str': 'Hiatal Hernia'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0450155', 'cui_str': 'Nonabsorbable mesh (physical object)'}, {'cui': 'C0014857', 'cui_str': 'Repair of parahiatal diaphragmatic hernia (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0412103', 'cui_str': 'Barium meal (procedure)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]",126.0,0.479725,"No advantages were demonstrated for mesh repair at up to 5 years follow-up, and symptom outcomes were worse after repair with absorbable mesh.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Watson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Thompson', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Devitt', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Aly', 'Affiliation': 'University of Melbourne Department of Surgery, Austin Hospital, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Irvine', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Woods', 'Affiliation': 'Cabrini Hospital, Malvern, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gan', 'Affiliation': 'Flinders University Discipline of Surgery, Flinders Medical Centre, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Game', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Glyn G', 'Initials': 'GG', 'LastName': 'Jamieson', 'Affiliation': 'Discipline of Surgery, University of Adelaide, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}]",Annals of surgery,['10.1097/SLA.0000000000003734']
574,31264294,Model-based analysis on systemic availability of co-administered cannabinoids after controlled vaporised administration.,"BACKGROUND
The most important two medicinal cannabinoids are Δ 9 -tetrahydrocannabinol (THC) and cannabidiol (CBD). Vaporised administration is superior due to its higher systemic availability, lower individual variability and faster drug delivery. Although it is common THC is co-administered with CBD, the influence of CBD on the pharmacokinetics, especially the systemic availability of THC after vaporised administration, is unknown.
AIMS
To investigate the influence of different doses of co-administered CBD on the systemic availability of THC, and to compare the availability of THC and CBD in a sample of frequent and infrequent cannabis users.
METHODS
The study used a randomised, double-blind, crossover placebo-controlled design. THC and/or CBD in ethanol was vaporised and inhaled. Plasma concentrations of THC and CBD were analysed. The THC data created in this study were pooled together with published THC pharmacokinetic data in order to cover all the phases of THC disposition. Population pharmacokinetic model of THC was developed based on the pooled data. The model of CBD was developed based on the data created in this study.
RESULTS
Population pharmacokinetic models of THC and CBD were developed. With concomitant inhalation of high-dose CBD, the systemic availability of THC decreased significantly. Frequent cannabis users appeared to have higher systemic availability of THC and CBD when high-dose CBD was administered.
CONCLUSIONS
The results observed in this study are useful for guiding future pharmacokinetic studies of medicinal cannabinoids, and for development of dosing guidelines for medical use of cannabis in the 'real-world' setting.",2020,"Frequent cannabis users appeared to have higher systemic availability of THC and CBD when high dose CBD was administered.
",[],"['placebo', 'THC', 'coadministered CBD', 'tetrahydrocannabinol']","['Plasma concentrations of THC and CBD', 'systemic availability of THC and CBD', 'systemic availability of THC', 'availability of THC and CBD', 'THC) and cannabidiol (CBD']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]",,0.0941398,"Frequent cannabis users appeared to have higher systemic availability of THC and CBD when high dose CBD was administered.
","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Galettis', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Broyd', 'Affiliation': 'School of Psychology and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Hendrika', 'Initials': 'H', 'LastName': 'van Hell', 'Affiliation': 'School of Psychology and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Lisa-Marie', 'Initials': 'LM', 'LastName': 'Greenwood', 'Affiliation': 'School of Psychology and Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Krey', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Solowij', 'Affiliation': 'The Australian Centre for Cannabinoid Clinical and Research Excellence, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Martin', 'Affiliation': 'Schools of Medicine and Public Health, University of Newcastle, Hunter Medical Research Institute, Newcastle, New South Wales, Australia.'}]",Internal medicine journal,['10.1111/imj.14415']
575,31256765,'Placement budgets' for supported employment: impact on employment rates in a multicentre randomised controlled trial.,"BACKGROUND
The most effective rehabilitation model for job (re-)entry of people with mental illness is supported employment. A barrier to introducing supported employment into standard care is its temporally unlimited provision, which conflicts with health and social legislation in many European countries.
AIMS
To test the impact of different 'placement budgets', i.e. a predefined maximum time budget for job seeking until take-up of competitive employment.
METHOD
Participants (116) were randomly assigned to 25 h, 40 h or 55 h placement budgets in an intent-to-treat analysis. We applied the individual placement and support model over 24 months, following participants for 36 months. Primary outcome was employment in the labour market for at least 3 months.
RESULTS
The proportion of participants obtaining competitive employment was 55.1% in the 25 h group, 37.8% in the 40 h group and 35.8% in the 55 h group. In a Cox regression analysis, time to employment was slightly lower in the 25 h group relative to the 40 h (hazard ratio 1.78, 95% CI 0.88-3.57, P = 0.107) and 55 h groups (hazard ratio 1.74, 95% CI 0.86-3.49, P = 0.122), but this was not statistically significant. The vast majority of all participants who found a job did so within the first 12 months (80.4%).
CONCLUSION
A restricted time budget for job finding and placement does not affect the rate of successful employment. In accordance with legislation, a restriction of care provision seems justified and enhances the chances of supported employment being introduced in statutory services.",2020,"The vast majority of all participants who found a job did so within the first 12 months (80.4%).
","['job (re-)entry of people with mental illness', 'Participants (116']",[],"['proportion of participants obtaining competitive employment', 'rate of successful employment', 'time to employment', 'employment in the labour market for at least 3 months']","[{'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]",[],"[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1318228', 'cui_str': 'Market (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",116.0,0.201813,"The vast majority of all participants who found a job did so within the first 12 months (80.4%).
","[{'ForeName': 'Wulf', 'Initials': 'W', 'LastName': 'Rössler', 'Affiliation': 'Professor, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Switzerland; Institute of Psychiatry, Laboratory of Neuroscience (LIM 27), University of Sao Paulo, Brazil; and Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Kawohl', 'Affiliation': 'Senior Consultant, Psychiatrische Dienste Aargau AG, Klinik für Psychiatrie und Psychotherapie, Switzerland.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Nordt', 'Affiliation': 'Senior Researcher, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, Switzerland.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Haker', 'Affiliation': 'Senior Researcher, Translational Neuromodeling Unit, Institute for Biomedical Engineering, University of Zurich and ETH Zurich, Switzerland.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rüsch', 'Affiliation': 'Professor, Section of Public Mental Health, University of Ulm, Germany.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Hengartner', 'Affiliation': 'Senior Lecturer, Department of Applied Psychology, Zurich University of Applied Sciences, Switzerland.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.154']
576,31294749,Effect of Pembrolizumab After Stereotactic Body Radiotherapy vs Pembrolizumab Alone on Tumor Response in Patients With Advanced Non-Small Cell Lung Cancer: Results of the PEMBRO-RT Phase 2 Randomized Clinical Trial.,"Importance
Many patients with advanced non-small cell lung cancer (NSCLC) receiving immunotherapy show primary resistance. High-dose radiotherapy can lead to increased tumor antigen release, improved antigen presentation, and T-cell infiltration. This radiotherapy may enhance the effects of checkpoint inhibition.
Objective
To assess whether stereotactic body radiotherapy on a single tumor site preceding pembrolizumab treatment enhances tumor response in patients with metastatic NSCLC.
Design, Setting, and Participants
Multicenter, randomized phase 2 study (PEMBRO-RT) of 92 patients with advanced NSCLC enrolled between July 1, 2015, and March 31, 2018, regardless of programmed death-ligand 1 (PD-L1) status. Data analysis was of the intention-to-treat population.
Interventions
Pembrolizumab (200 mg/kg every 3 weeks) either alone (control arm) or after radiotherapy (3 doses of 8 Gy) (experimental arm) to a single tumor site until confirmed radiographic progression, unacceptable toxic effects, investigator decision, patient withdrawal of consent, or a maximum of 24 months.
Main Outcomes and Measures
Improvement in overall response rate (ORR) at 12 weeks from 20% in the control arm to 50% in the experimental arm with P < .10.
Results
Of the 92 patients enrolled, 76 were randomized to the control arm (n = 40) or the experimental arm (n = 36). Of those, the median age was 62 years (range, 35-78 years), and 44 (58%) were men. The ORR at 12 weeks was 18% in the control arm vs 36% in the experimental arm (P = .07). Median progression-free survival was 1.9 months (95% CI, 1.7-6.9 months) vs 6.6 months (95% CI, 4.0-14.6 months) (hazard ratio, 0.71; 95% CI, 0.42-1.18; P = .19), and median overall survival was 7.6 months (95% CI, 6.0-13.9 months) vs 15.9 months (95% CI, 7.1 months to not reached) (hazard ratio, 0.66; 95% CI, 0.37-1.18; P = .16). Subgroup analyses showed the largest benefit from the addition of radiotherapy in patients with PD-L1-negative tumors. No increase in treatment-related toxic effects was observed in the experimental arm.
Conclusions and Relevance
Stereotactic body radiotherapy prior to pembrolizumab was well tolerated. Although a doubling of ORR was observed, the results did not meet the study's prespecified end point criteria for meaningful clinical benefit. Positive results were largely influenced by the PD-L1-negative subgroup, which had significantly improved progression-free survival and overall survival. These results suggest that a larger trial is necessary to determine whether radiotherapy may activate noninflamed NSCLC toward a more inflamed tumor microenvironment.
Trial Registration
ClinicalTrials.gov identifier: NCT02492568.",2019,"Positive results were largely influenced by the PD-L1-negative subgroup, which had significantly improved progression-free survival and overall survival.","['92 patients enrolled', 'patients with metastatic NSCLC', 'Of those, the median age was 62 years (range, 35-78 years), and 44 (58%) were men', 'patients with PD-L1-negative tumors', 'Patients With Advanced Non-Small Cell Lung Cancer', 'patients with advanced non-small cell lung cancer (NSCLC) receiving immunotherapy show primary resistance', '92 patients with advanced NSCLC enrolled between July 1, 2015, and March 31, 2018, regardless of programmed death-ligand 1 (PD-L1) status']","['Pembrolizumab (200 mg/kg every 3 weeks) either alone (control arm) or after radiotherapy', 'Stereotactic Body Radiotherapy vs Pembrolizumab Alone', 'Pembrolizumab', 'pembrolizumab', 'radiotherapy', 'stereotactic body radiotherapy', 'High-dose radiotherapy']","['ORR', 'Tumor Response', 'tolerated', 'tumor antigen release, improved antigen presentation, and T-cell infiltration', 'treatment-related toxic effects', 'overall response rate (ORR', 'Median progression-free survival', 'progression-free survival and overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0041361', 'cui_str': 'Tumor Antigens'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0206431', 'cui_str': 'Antigen Presentation'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",76.0,0.351183,"Positive results were largely influenced by the PD-L1-negative subgroup, which had significantly improved progression-free survival and overall survival.","[{'ForeName': 'Willemijn S M E', 'Initials': 'WSME', 'LastName': 'Theelen', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Heike M U', 'Initials': 'HMU', 'LastName': 'Peulen', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Ferry', 'Initials': 'F', 'LastName': 'Lalezari', 'Affiliation': 'Department of Radiology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'van der Noort', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Jeltje F', 'Initials': 'JF', 'LastName': 'de Vries', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Joachim G J V', 'Initials': 'JGJV', 'LastName': 'Aerts', 'Affiliation': 'Department of Pulmonology, Erasmus Medical Center, Rotterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Daphne W', 'Initials': 'DW', 'LastName': 'Dumoulin', 'Affiliation': 'Department of Pulmonology, Erasmus Medical Center, Rotterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Bahce', 'Affiliation': 'Department of Pulmonology, VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Anna-Larissa N', 'Initials': 'AN', 'LastName': 'Niemeijer', 'Affiliation': 'Department of Pulmonology, VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Adrianus J', 'Initials': 'AJ', 'LastName': 'de Langen', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Monkhorst', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Amsterdam.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baas', 'Affiliation': 'Department of Thoracic Oncology, Netherlands Cancer Institute, Amsterdam.'}]",JAMA oncology,['10.1001/jamaoncol.2019.1478']
577,29888944,Silence is golden: The effect of verbalization on group performance.,"Contrary to the popular belief that collaboration brings better problem solutions, empirical studies have revealed that interacting groups often performed worse than noninteracting ""nominal"" groups. Past studies mainly examined how overhearing others' ideas impacts group performance. This study investigated the impact of another essential but overlooked group communicative process-verbalizing ideas to others-on group performance. Participants (N = 156) solved 20 verbal puzzles either alone quietly, alone thinking-aloud, or in verbalizing pairs. Participants in the same working-alone condition were randomly paired to form nominal pairs and their pooled performance was treated as nominal group performance. Relative to the quiet nominal group, the performance of the thinking-aloud nominal and interacting groups were impaired to similar extents. These two groups also demonstrated a similar limited capacity to expand the search scope. The equivalency of the interacting and thinking-aloud nominal group results suggest that verbalization is a key factor in groups' inferior performance. (PsycINFO Database Record",2018,"Relative to the quiet nominal group, the performance of the thinking-aloud nominal and interacting groups were impaired to similar extents.","['Participants in the same working-alone condition', 'Participants (N = 156) solved 20']","['verbal puzzles either alone quietly, alone thinking-aloud, or in verbalizing pairs']",[],"[{'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0423995', 'cui_str': 'Puzzled (finding)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}]",[],156.0,0.0185654,"Relative to the quiet nominal group, the performance of the thinking-aloud nominal and interacting groups were impaired to similar extents.","[{'ForeName': 'Ut Na', 'Initials': 'UN', 'LastName': 'Sio', 'Affiliation': 'Department of Psychology, Carnegie Mellon University.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kotovsky', 'Affiliation': 'Department of Psychology, Carnegie Mellon University.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Cagan', 'Affiliation': 'Department of Psychology, Carnegie Mellon University.'}]",Journal of experimental psychology. General,['10.1037/xge0000456']
578,29975092,Shifting the balance between goals and habits: Five failures in experimental habit induction.,"Habits are repetitive behaviors that become ingrained with practice, routine, and repetition. The more we repeat an action, the stronger our habits become. Behavioral and clinical neuroscientists have become increasingly interested in this topic because habits may contribute to aspects of maladaptive human behavior, such as compulsive behavior in psychiatry. Numerous studies have demonstrated that habits can be induced in otherwise healthy rats by simply overtraining stimulus-response behaviors. However, despite growing interest in this topic and its application to psychiatry, a similar body of work in humans is absent. Only a single study has been published in humans that shows the effect of extensive training on habit expression. Here, we report five failed attempts to demonstrate that overtraining instrumental behavior leads to the development of inflexible habits in humans, using variants of four previously published outcome devaluation paradigms. Extensive training did not lead to greater habits in two versions of an avoidance learning task, in an appetitive slips-of-action task, or in two independent attempts to replicate the original demonstration. The finding that these outcome devaluation procedures may be insensitive to duration of stimulus-response training in humans has implications for prior work in psychiatric populations. Specifically, it converges with the suggestion that the failures in outcome devaluation in compulsive individuals reflect dysfunction in goal-directed control, rather than overactive habit learning. We discuss why habits are difficult to experimentally induce in healthy humans, and the implications of this for future research in healthy and disordered populations. (PsycINFO Database Record",2018,"Extensive training did not lead to greater habits in two versions of an avoidance learning task, in an appetitive slips-of-action task, or in two independent attempts to replicate the original demonstration.",['healthy humans'],"['extensive training', 'Extensive training']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],,0.0151666,"Extensive training did not lead to greater habits in two versions of an avoidance learning task, in an appetitive slips-of-action task, or in two independent attempts to replicate the original demonstration.","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'de Wit', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Knot', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Aukje A C', 'Initials': 'AAC', 'LastName': 'Verhoeven', 'Affiliation': 'Department of Clinical Psychology.'}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': 'Department of Psychology, University of Cambridge.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gasull-Camos', 'Affiliation': 'Department of Neurochemistry and Neuropharmacology, Institute of Biomedical Research Barcelona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Department of Psychology, New York University.'}, {'ForeName': 'Hira', 'Initials': 'H', 'LastName': 'Mirza', 'Affiliation': 'Department of Psychology, New York University.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Gillan', 'Affiliation': 'School of Psychology and Global Brain Health Institute, Trinity College Dublin.'}]",Journal of experimental psychology. General,['10.1037/xge0000402']
579,32409493,Exercise-Induced Increases in Insulin Sensitivity After Bariatric Surgery Are Mediated By Muscle Extracellular Matrix Remodeling.,"Exercise seems to enhance the beneficial effect of bariatric (Roux-en-Y gastric bypass [RYGB]) surgery on insulin resistance. We hypothesized that skeletal muscle extracellular matrix (ECM) remodeling may underlie these benefits. Women were randomized to either a combined aerobic and resistance exercise training program following RYGB (RYGB + ET) or standard of care (RYGB). Insulin sensitivity was assessed by oral glucose tolerance test. Muscle biopsy specimens were obtained at baseline and 3 and 9 months after surgery and subjected to comprehensive phenotyping, transcriptome profiling, molecular pathway identification, and validation in vitro. Exercise training improved insulin sensitivity beyond surgery alone (e.g., Matsuda index: RYGB 123% vs. RYGB + ET 325%; P ≤ 0.0001). ECM remodeling was reduced by surgery alone, with an additive benefit of surgery and exercise training (e.g., collagen I: RYGB -41% vs. RYGB + ET -76%; P ≤ 0.0001). Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling. We identified candidates modulated by exercise training that may become therapeutic targets for treating insulin resistance, in particular, the transforming growth factor-β1/SMAD 2/3 pathway and its antagonist follistatin. Exercise-induced increases in insulin sensitivity after bariatric surgery are at least partially mediated by muscle ECM remodeling.",2020,"Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling.",[],"['surgery and exercise training ( e.g., collagen', 'combined aerobic and resistance exercise training program following RYGB or standard of care (RYGB', 'I - RYGB', 'exercise training']","['enhancing insulin sensitivity', 'ECM remodeling', 'insulin resistance and ECM remodeling', 'Insulin Sensitivity', 'insulin sensitivity', 'Insulin sensitivity']",[],"[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0522588,"Exercise and RYGB had an additive effect on enhancing insulin sensitivity, but surgery alone did not resolve insulin resistance and ECM remodeling.","[{'ForeName': 'Wagner S', 'Initials': 'WS', 'LastName': 'Dantas', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hamilton', 'Initials': 'H', 'LastName': 'Roschel', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Igor H', 'Initials': 'IH', 'LastName': 'Murai', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Gil', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gangarao', 'Initials': 'G', 'LastName': 'Davuluri', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Sujoy', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Genomics Core, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Newman', 'Affiliation': 'Genomics Core, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Samuel K', 'Initials': 'SK', 'LastName': 'Shinjo', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Willian', 'Initials': 'W', 'LastName': 'das Neves', 'Affiliation': 'Clinical Oncology Service, Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Merege-Filho', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Walcy R', 'Initials': 'WR', 'LastName': 'Teodoro', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Vera L', 'Initials': 'VL', 'LastName': 'Capelozzi', 'Affiliation': 'Department of Pathology, School of Medicine, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Pereira', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fabiana B', 'Initials': 'FB', 'LastName': 'Benatti', 'Affiliation': 'School of Applied Sciences, Universidade Estadual de Campinas, São Paulo, Brazil.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'de Sá-Pinto', 'Affiliation': 'Rheumatology Division, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'de Cleva', 'Affiliation': 'Department of Digestive Division, School of Medicine, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Santo', 'Affiliation': 'Department of Digestive Division, School of Medicine, Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Integrated Physiology and Molecular Metabolism Laboratory, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Gualano', 'Affiliation': 'Applied Physiology and Nutrition Research Group, School of Physical Education and Sport, Laboratory of Assessment and Conditioning in Rheumatology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil gualano@usp.br.'}]",Diabetes,['10.2337/db19-1180']
580,31801155,"Meningitis, urinary tract, and bloodstream infections in very low birth weight infants enrolled in a heart rate characteristics monitoring trial.","BACKGROUND
Displaying heart rate characteristic (HRC) scores was associated with lower sepsis-associated mortality in very low birth weight (VLBW) infants in a multicenter randomized controlled trial (HeRO trial). The aim of this study was to test whether HRC indices rise before diagnosis of urinary tract infection (UTI) or meningitis, with and without concomitant BSI.
METHODS
Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants. The HRC index was analyzed 12 h prior to positive cultures compared to 36 h prior, using paired signed-rank tests.
RESULTS
UTI, meningitis, and BSI were diagnosed in 10%, 2%, and 24% of infants, respectively. The mean hourly HRC index was significantly higher 12 h prior to diagnosis of UTI and BSI compared to 36 h prior (UTI 2.07 versus 1.81; BSI 2.62 versus 2.25, both p < 0.0001). The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
CONCLUSIONS
In a large cohort of VLBW infants enrolled in the HeRO trial, the HRC index increased in the 24-h period prior to diagnosis of UTI and BSI but not meningitis.",2020,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","['Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants', 'very low birth weight infants enrolled in a heart rate characteristic monitoring trial']",[],"['HRC index', 'baseline HRC index', 'Meningitis, urinary tract, and bloodstream infections', 'mean hourly HRC index', 'UTI, meningitis, and BSI']","[{'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0430403', 'cui_str': 'Cerebrospinal fluid culture (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0042027'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",,0.151055,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis.
","[{'ForeName': 'Joern-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. hendrik.weitkamp@vumc.org.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Aschner', 'Affiliation': 'Pediatrics, Hackensack Meridian Health School of Medicine, Nutley, NJ, USA.'}, {'ForeName': 'Wallly A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bancalari', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Perez', 'Affiliation': 'Pediatrix Medical Group, Orlando, FL, USA.'}, {'ForeName': 'Cristina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Whit Walker', 'Affiliation': 'USC School of Medicine, Greenville Memorial Hospital, Greenville, SC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Porcelli', 'Affiliation': 'Pediatrics, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Palmer', 'Affiliation': 'Pediatrics, Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grossarth', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}]",Pediatric research,['10.1038/s41390-019-0701-4']
581,31801982,Usefulness of the satiety quotient in a clinical pediatric obesity context.,"BACKGROUND
While the satiety quotient (SQ) is increasingly used in pediatric populations, the present study assessed its reliability and reproducibility in adolescents with obesity.
METHODS
Sixty-eight adolescents with obesity were enrolled. Anthropometric measurements and body composition (DXA) were assessed. They randomly completed two experimental sessions: (i) condition with a standardized breakfast used to calculate SQ (C1); (ii) condition with the same breakfast and ad libitum lunch and dinner buffet meals (C2). Appetite feelings were assessed at regular interval (visual analog scales).
RESULTS
SQ for hunger (SQH), satiety (SQS), prospective food consumption (SQP), and desire to eat (SQD) were calculated using the breakfast. SQH, SQD, and SQ mean did not differ between conditions (p = 0.41, 0.57, and 0.74, respectively) whereas SQS and SQP were significantly different between conditions (p = 0.007 and 0.005). None of the SQ was correlated with body weight (BW), BMI, or FM. There was no significant correlation between the SQ and the adolescent's ad libitum energy intake (lunch, dinner, and total). No differences were observed between adolescents with a low and high phenotype for BW, BMI, and FM% (p = 0.26, 0.30, and 0.83); total energy (p = 0.21); total protein intake (p = 0.28); total fat intake (p = 0.24) and total carbohydrate intake (p = 0.44). Thirty percent of the adolescents showed different satiety phenotype (low vs. high) between C1 and C2.
CONCLUSIONS
While the SQ is a reliable indicator in adults, it must be used with caution in adolescents with obesity due to its lack of association with anthropometric measurements, body composition, and energy and macronutrient intakes in this population.",2020,"SQH, SQD, and SQ mean did not differ between conditions (p = 0.41, 0.57, and 0.74, respectively) whereas SQS and SQP were significantly different between conditions (p = 0.007 and 0.005).","['Sixty-eight adolescents with obesity were enrolled', 'adolescents with obesity']",['experimental sessions: (i) condition with a standardized breakfast used to calculate SQ (C1); (ii) condition with the same breakfast and ad libitum lunch and dinner buffet meals (C2'],"['satiety phenotype', 'hunger (SQH), satiety (SQS), prospective food consumption (SQP), and desire to eat (SQD', ""adolescent's ad libitum energy intake (lunch, dinner, and total"", 'SQS and SQP', 'total energy', 'total fat intake', 'Appetite feelings', 'SQH, SQD, and SQ mean', 'total carbohydrate intake', 'total protein intake', 'Anthropometric measurements and body composition (DXA', 'body weight (BW), BMI, or FM', 'adolescents with a low and high phenotype for BW, BMI, and FM']","[{'cui': 'C0450387', 'cui_str': '68 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",68.0,0.0330347,"SQH, SQD, and SQ mean did not differ between conditions (p = 0.41, 0.57, and 0.74, respectively) whereas SQS and SQP were significantly different between conditions (p = 0.007 and 0.005).","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), EA 3533, Clermont Auvergne University, Clermont-Ferrand, France. fillonalicia@gmail.com.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics unit (DRCI), Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), EA 3533, Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Mathieu', 'Affiliation': 'School of kinesiology and physical activity sciences, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Drapeau', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Institute of Nutrition and Functional Foods (INAF), Université Laval, Quebec City, QC, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'CRNH-Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), EA 3533, Clermont Auvergne University, Clermont-Ferrand, France.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0540-8']
582,31685516,Multicentre randomised double-blind placebo controlled trial of combination vancomycin and cefazolin surgical antibiotic prophylaxis: the Australian surgical antibiotic prophylaxis (ASAP) trial.,"INTRODUCTION
Resistant Gram-positive organisms, such as methicillin-resistant staphylococci, account for a significant proportion of infections following joint replacement surgery. Current surgical antimicrobial prophylaxis guidelines recommend the use of first-generation or second-generation cephalosporin antibiotics, such as cefazolin. Cefazolin, however, does not prevent infections due to these resistant organisms; therefore, new prevention strategies need to be examined. One proposed strategy is to combine a glycopeptide antibiotic with cefazolin for prophylaxis. The clinical benefit and cost-effectiveness of this combination therapy compared with usual therapy, however, have not been established.
METHODS AND ANALYSIS
This randomised, double-blind, parallel, superiority, placebo-controlled, phase 4 trial will compare the incidence of all surgical site infections (SSIs) including superficial, deep and organ/space (prosthetic joint) infections, safety and cost-effectiveness of surgical prophylaxis with cefazolin plus vancomycin to that with cefazolin plus placebo. The study will be performed in patients undergoing joint replacement surgery. In the microbiological sub-studies, we will examine the incidence of SSIs in participants with preoperative staphylococci colonisation (Sub-Study 1) and incidence of VRE acquisition (Sub-Study 2). The trial will recruit 4450 participants over a 4-year period across 13 orthopaedic centres in Australia. The primary outcome is the incidence of SSI at 90 days post index surgery. Secondary outcomes include the incidence of SSI according to joint and microorganism and other healthcare associated infections. Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality. The primary and secondary analysis will be a modified intention-to-treat analysis consisting of all randomised participants who undergo eligible surgery. We will also perform a per-protocol analysis.
ETHICS AND DISSEMINATION
The study protocol was reviewed and approved by The Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/102) on 9 July 2018. Study findings will be disseminated in the printed media, and learnt forums.
TRIAL REGISTRATION NUMBER
ACTRN12618000642280.",2019,"Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality.","['patients undergoing joint replacement surgery', '4450 participants over a 4-year period across 13 orthopaedic centres in Australia', 'participants with preoperative staphylococci colonisation (Sub-Study 1) and incidence of VRE acquisition (Sub-Study 2']","['cefazolin', 'cefazolin plus placebo', 'placebo', 'cefazolin plus vancomycin', 'Cefazolin', 'combination vancomycin and cefazolin surgical antibiotic prophylaxis']","['incidence of all surgical site infections (SSIs) including superficial, deep and organ/space (prosthetic joint) infections, safety and cost-effectiveness', 'incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality', 'incidence of SSI according to joint and microorganism and other healthcare associated infections', 'incidence of SSI at 90 days post index surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0185317', 'cui_str': 'Joint Replacement'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}]","[{'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0445623', 'cui_str': 'Microorganism (organism)'}, {'cui': 'C0010356', 'cui_str': 'Healthcare Associated Infections'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",13.0,0.67242,"Safety endpoints include the incidence of acute kidney injury, hypersensitivity reactions and all-cause mortality.","[{'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Peel', 'Affiliation': 'Infectious Diseases, Monash University, Melbourne, Victoria, Australia Trisha.Peel@monash.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Astbury', 'Affiliation': 'Infectious Diseases, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Infectious Diseases Unit, Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paterson', 'Affiliation': 'Centre for Clinical Research, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Buising', 'Affiliation': 'Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Spelman', 'Affiliation': ""Department of Surgery, St Vincent's Hospital, The University of Melbourne, Melbourne, Victoria, Australia.""}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Tran-Duy', 'Affiliation': 'Centre for Health Policy, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'de Steiger', 'Affiliation': 'Surgery, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033718']
583,32125052,Family health history collected by virtual conversational agents: An empirical study to investigate the efficacy of this approach.,"Family health history (FHx) is one of the simplest and most cost-effective and efficient ways to collect health information that could help diagnose and treat genetic diseases at an early stage. This study evaluated the efficacy of collecting such family health histories through a virtual conversational agent (VCA) interface, a new method for collecting this information. Standard and VCA interfaces for FHx collection were investigated with 50 participants, recruited via email and word of mouth, using a within-subject experimental design with the order of the interfaces randomized and counterbalanced. Interface workload, usability, preference, and satisfaction were assessed using the NASA Task Load Index workload instrument, the IBM Computer System Usability Questionnaire, and a brief questionnaire derived from the Technology Acceptance Model. The researchers also recorded the number of errors and the total task completion time. It was found that the completion times for 2 of the 5 tasks were shorter for the VCA interface than for the standard one, but the overall completion time was longer (17 min 44 s vs. 16 min 51 s, p = .019). We also found the overall workload to be significantly lower (34.32 vs. 42.64, p = .003) for the VCA interface, and usability metrics including overall satisfaction (5.62 vs. 4.72, p < .001), system usefulness (5.76 vs. 4.84, p = .001), information quality (5.43 vs. 4.62, p < .001), and interface quality (5.66 vs. 4.64, p < .001) to be significantly higher for this interface as well. Approximately 3 out of 4 participants preferred the VCA interface to the standard one. Although the overall time taken was slightly longer than with standard interface, the VCA interface was rated significantly better across all other measures and was preferred by the participants. These findings demonstrate the advantages of an innovative VCA interface for collecting FHx, validating the efficacy of using VCAs to collect complex patient-specific data in health care.",2020,"Although the overall time taken was slightly longer than with standard interface, the VCA interface was rated significantly better across all other measures and was preferred by the participants.",['44\xa0s vs. 16'],['virtual conversational agents'],"['Interface workload, usability, preference, and satisfaction', 'NASA Task Load Index workload instrument, the IBM Computer System Usability Questionnaire, and a brief questionnaire', 'interface quality', 'overall workload', 'overall completion time', 'overall satisfaction', 'information quality', 'number of errors and the total task completion time', 'overall time taken']",[],"[{'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0242776', 'cui_str': 'NASA'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",4.0,0.0329553,"Although the overall time taken was slightly longer than with standard interface, the VCA interface was rated significantly better across all other measures and was preferred by the participants.","[{'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Ponathil', 'Affiliation': 'Glenn Department of Civil Engineering, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Firat', 'Initials': 'F', 'LastName': 'Ozkan', 'Affiliation': 'Department of Industrial Engineering, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Welch', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bertrand', 'Affiliation': 'Department of Industrial Engineering, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Chalil Madathil', 'Affiliation': 'Glenn Department of Civil Engineering, Clemson University, Clemson, SC, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1239']
584,31796827,Expanding the parameter space of anodal transcranial direct current stimulation of the primary motor cortex.,"Size and duration of the neuroplastic effects of tDCS depend on stimulation parameters, including stimulation duration and intensity of current. The impact of stimulation parameters on physiological effects is partially non-linear. To improve the utility of this intervention, it is critical to gather information about the impact of stimulation duration and intensity on neuroplasticity, while expanding the parameter space to improve efficacy. Anodal tDCS of 1-3 mA current intensity was applied for 15-30 minutes to study motor cortex plasticity. Sixteen healthy right-handed non-smoking volunteers participated in 10 sessions (intensity-duration pairs) of stimulation in a randomized cross-over design. Transcranial magnetic stimulation (TMS)-induced motor-evoked potentials (MEP) were recorded as outcome measures of tDCS effects until next evening after tDCS. All active stimulation conditions enhanced motor cortex excitability within the first 2 hours after stimulation. We observed no significant differences between the three stimulation intensities and durations on cortical excitability. A trend for larger cortical excitability enhancements was however observed for higher current intensities (1 vs 3 mA). These results add information about intensified tDCS protocols and suggest that the impact of anodal tDCS on neuroplasticity is relatively robust with respect to gradual alterations of stimulation intensity, and duration.",2019,We observed no significant differences between the three stimulation intensities and durations on cortical excitability.,['Sixteen healthy right-handed non-smoking volunteers'],"['Transcranial magnetic stimulation (TMS)-induced motor-evoked potentials (MEP', 'tDCS']","['stimulation duration and intensity of current', 'cortical excitability', 'motor cortex excitability']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}]",16.0,0.0447522,We observed no significant differences between the three stimulation intensities and durations on cortical excitability.,"[{'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Agboada', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mosayebi Samani', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Jamil', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Min-Fang', 'Initials': 'MF', 'LastName': 'Kuo', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany. nitsche@ifado.de.'}]",Scientific reports,['10.1038/s41598-019-54621-0']
585,31712348,Evaluation of the efficacy of 3D total-body photography with sequential digital dermoscopy in a high-risk melanoma cohort: protocol for a randomised controlled trial.,"INTRODUCTION
Melanoma is Australia's fourth most common cancer. Early detection is fundamental in maximising health outcomes and minimising treatment costs. To date, population-based screening programmes have not been justified in health economic studies. However, a skin surveillance approach targeting high-risk individuals could improve the cost-benefit ratio.
METHODS AND ANALYSIS
This paper describes a 2-year longitudinal randomised controlled trial (RCT) to compare routine clinical care (control) with an intensive skin surveillance programme (intervention) consisting of novel three-dimensional (3D) total-body photography (TBP), sequential digital dermoscopy and melanoma-risk stratification, in a high-risk melanoma cohort. Primary outcomes will evaluate clinical, economic and consumer impact of the intervention. Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed. A health economic analysis using government data repositories will capture healthcare utilisation and costs relating to skin surveillance. Consumer questionnaires will examine intervention acceptability, the psychological impact, and attitudes towards melanoma risk and sun protective behaviour. Secondary outcomes include the development of a holistic risk algorithm incorporating clinical, phenotypic and genetic factors to facilitate the identification of those most likely to benefit from this surveillance approach. Furthermore, the feasibility of integrating the intervention with teledermatology to enhance specialist care in remote locations will be evaluated. This will be the first RCT to compare a targeted surveillance programme utilising new 3D TBP technology against current routine clinical care for individuals at high risk of melanoma.
ETHICS AND DISSEMINATION
This study has received Human Research Ethics Committee (HREC) approval from both Metro South Health HREC (HREC/17/QPAH/816) and The University of Queensland HREC (2018000074).
TRIAL REGISTRATION NUMBER
ANZCTR12618000267257; Pre-results.",2019,"Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed.",['individuals at high risk of melanoma'],"['3D total-body photography with sequential digital dermoscopy', 'routine clinical care (control) with an intensive skin surveillance programme (intervention) consisting of novel three-dimensional (3D) total-body photography (TBP), sequential digital dermoscopy and melanoma-risk stratification']","['development of a holistic risk algorithm incorporating clinical, phenotypic and genetic factors to facilitate the identification of those most likely to benefit from this surveillance approach', 'clinical, economic and consumer impact of the intervention', 'rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1449565', 'cui_str': 'Dermoscopy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0150350', 'cui_str': 'Skin surveillance'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0002045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0948553', 'cui_str': 'Lesion excision'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",,0.380854,"Clinical outcomes will evaluate differences in the rate of lesion excisions/biopsies per person, benign to malignant ratio for excisions and thickness of melanomas diagnosed.","[{'ForeName': 'Clare Amy', 'Initials': 'CA', 'LastName': 'Primiero', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Aideen M', 'Initials': 'AM', 'LastName': 'McInerney-Leo', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Brigid', 'Initials': 'B', 'LastName': 'Betz-Stablein', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Whiteman', 'Affiliation': 'Cancer Control Group, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gordon', 'Affiliation': 'Population Health, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Caffery', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Aitken', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Eakin', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Osborne', 'Affiliation': 'School of Nursing and Midwifery, University of Southern Queensland, Toowoomba, Queensland, Australia.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Centre for Online Health, Centre for Health Services Research, The University of Queensland, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'B Mark', 'Initials': 'BM', 'LastName': 'Smithers', 'Affiliation': 'Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Janda', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'H Peter', 'Initials': 'HP', 'LastName': 'Soyer', 'Affiliation': 'The University of Queensland Diamantina Institute, Dermatology Research Centre, The University of Queensland, Brisbane, Queensland, Australia p.soyer@uq.edu.au.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Finnane', 'Affiliation': 'School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032969']
586,31792263,"Aging, sex and cognitive Theory of Mind: a transcranial direct current stimulation study.","Aging is accompanied by changes in cognitive abilities and a great interest is spreading among researchers about aging impact on social cognition skills, such as the Theory of Mind (ToM). Transcranial direct current stimulation (tDCS) has been used in social cognition studies founding evidence of sex-related different effects on cognitive ToM task in a young people sample. In this randomized, double-blind, sham-controlled study, we applied one active and one sham tDCS session on the medial prefrontal cortex (mPFC) during a cognitive ToM task, including both social (i.e., communicative) and nonsocial (i.e., private) intention attribution conditions, in sixty healthy aging individuals (30 males and 30 females). In half of the participants the anode was positioned over the mPFC, whereas in the other half the cathode was positioned over the mPFC. The results showed that: (i) anodal tDCS over the mPFC led to significant slower reaction times (vs. sham) for social intention attribution task only in female participants; (ii) No effects were found in both females and males during cathodal stimulation. We show for the first time sex-related differences in cognitive ToM abilities in healthy aging, extending previous findings concerning young participants.",2019,The results showed that: (i) anodal tDCS over the mPFC led to significant slower reaction times (vs. sham) for social intention attribution task only in female participants; (ii) No effects were found in both females and males during cathodal stimulation.,['sixty healthy aging individuals (30 males and 30 females'],"['sham tDCS session', 'cognitive ToM task, including both social (i.e., communicative) and nonsocial (i.e., private) intention attribution conditions', 'Transcranial direct current stimulation (tDCS']","['cognitive ToM abilities', 'reaction times', 'social intention attribution task']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",60.0,0.0376592,The results showed that: (i) anodal tDCS over the mPFC led to significant slower reaction times (vs. sham) for social intention attribution task only in female participants; (ii) No effects were found in both females and males during cathodal stimulation.,"[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Adenzato', 'Affiliation': 'Department of Psychology, University of Turin, Turin, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Manenti', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gobbi', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Enrici', 'Affiliation': 'Department of Philosophy and Educational Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Danila', 'Initials': 'D', 'LastName': 'Rusich', 'Affiliation': 'Department of Human Science, LUMSA University, Roma, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cotelli', 'Affiliation': 'Neuropsychology Unit, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy. mcotelli@fatebenefratelli.eu.'}]",Scientific reports,['10.1038/s41598-019-54469-4']
587,31658058,Concentration-Dependent Activity of Hydromethylthionine on Cognitive Decline and Brain Atrophy in Mild to Moderate Alzheimer's Disease.,"BACKGROUND
Although hydromethylthionine is a potent tau aggregation inhibitor, no difference was found in either of two Phase III trials in mild to moderate Alzheimer's disease (AD) comparing doses in the range 150-250 mg/day with 8 mg/day intended as a control.
OBJECTIVE
To determine how drug exposure is related to treatment response.
METHODS
A sensitive plasma assay for the drug was used in a population pharmacokinetic analysis of samples from 1,162 of the 1,686 patients who participated in either of the Phase III trials with available samples and efficacy outcome data.
RESULTS
There are steep concentration-response relationships for steady state plasma levels in the range 0.3-0.8 ng/ml at the 8 mg/day dose. Using a threshold based on the lower limit of quantitation of the assay on Day 1, there are highly significant differences in cognitive decline and brain atrophy in patients with above threshold plasma levels, both for monotherapy and add-on therapy, but with effect sizes reduced by half as add-on. Plasma concentrations in the range 4-21 ng/ml produced by the high doses are not associated with any additional benefit.
CONCLUSIONS
Hydromethylthionine has pharmacological activity on brain structure and function at the 8 mg/day dose as monotherapy or as add-on to symptomatic treatments. This combined with a plateau at higher doses is consistent with the lack of dose-response seen in the Phase III trials. Treatment benefit is predicted to be maximal at 16 mg/day as monotherapy. A placebo-controlled trial in mild/moderate AD is now ongoing to confirm efficacy at this dose.",2019,"Plasma concentrations in the range 4-21 ng/ml produced by the high doses are not associated with any additional benefit.
","[""Mild to Moderate Alzheimer's Disease"", 'population pharmacokinetic analysis of samples from 1,162 of the 1,686 patients who participated in either of the Phase III trials with available samples and efficacy outcome data']","['placebo', 'hydromethylthionine', 'Hydromethylthionine']","['steep concentration-response relationships for steady state plasma levels', 'cognitive decline and brain atrophy', 'Plasma concentrations']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}]",1686.0,0.0767765,"Plasma concentrations in the range 4-21 ng/ml produced by the high doses are not associated with any additional benefit.
","[{'ForeName': 'Bjoern O', 'Initials': 'BO', 'LastName': 'Schelter', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Shiells', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Baddeley', 'Affiliation': 'Department of Chemistry, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Rubino', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Ganesan', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hammel', 'Affiliation': 'Institute of Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Vuksanovic', 'Affiliation': 'Aberdeen Biomedical Imaging Center, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Roger T', 'Initials': 'RT', 'LastName': 'Staff', 'Affiliation': 'Aberdeen Royal Infirmary, NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Murray', 'Affiliation': 'Aberdeen Biomedical Imaging Center, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bracoud', 'Affiliation': 'Bioclinica, Lyon, France.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Riedel', 'Affiliation': 'School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Foresterhill, Aberdeen, UK.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gauthier', 'Affiliation': ""McGill Centre for Studies in Aging, Alzheimer's Disease Research Unit, and Douglas Mental Health University Institute, Montreal, QC, Canada.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Innovation Center for Neurological Disorders, Neurology Department, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bentham', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Kook', 'Affiliation': 'Salamandra LLC, Bethesda, MD, USA.'}, {'ForeName': 'John M D', 'Initials': 'JMD', 'LastName': 'Storey', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Harrington', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}, {'ForeName': 'Claude M', 'Initials': 'CM', 'LastName': 'Wischik', 'Affiliation': 'TauRx Therapeutics Ltd., Singapore, Singapore.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190772']
588,31227373,"Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial.","BACKGROUND
Hypofractionated radiotherapy for prostate cancer has gained increased attention due to its proposed high radiation-fraction sensitivity. Recent reports from studies comparing moderately hypofractionated and conventionally fractionated radiotherapy support the clinical use of moderate hypofractionation. To date, there are no published randomised studies on ultra-hypofractionated radiotherapy. Here, we report the outcomes of the Scandinavian HYPO-RT-PC phase 3 trial with the aim to show non-inferiority of ultra-hypofractionation compared with conventional fractionation.
METHODS
In this open-label, randomised, phase 3 non-inferiority trial done in 12 centres in Sweden and Denmark, we recruited men up to 75 years of age with intermediate-to-high-risk prostate cancer and a WHO performance status between 0 and 2. Patients were randomly assigned to ultra-hypofractionation (42·7 Gy in seven fractions, 3 days per week for 2·5 weeks) or conventional fractionated radiotherapy (78·0 Gy in 39 fractions, 5 days per week for 8 weeks). No androgen deprivation therapy was allowed. The primary endpoint was time to biochemical or clinical failure, analysed in the per-protocol population. The prespecified non-inferiority margin was 4% at 5 years, corresponding to a critical hazard ratio (HR) limit of 1·338. Physician-recorded toxicity was measured according to the Radiation Therapy Oncology Group (RTOG) morbidity scale and patient-reported outcome measurements with the Prostate Cancer Symptom Scale (PCSS) questionnaire. This trial is registered with the ISRCTN registry, number ISRCTN45905321.
FINDINGS
Between July 1, 2005, and Nov 4, 2015, 1200 patients were randomly assigned to conventional fractionation (n=602) or ultra-hypofractionation (n=598), of whom 1180 (591 conventional fractionation and 589 ultra-hypofractionation) constituted the per-protocol population. 1054 (89%) participants were intermediate risk and 126 (11%) were high risk. Median follow-up time was 5·0 years (IQR 3·1-7·0). The estimated failure-free survival at 5 years was 84% (95% CI 80-87) in both treatment groups, with an adjusted HR of 1·002 (95% CI 0·758-1·325; log-rank p=0·99). There was weak evidence of an increased frequency of acute physician-reported RTOG grade 2 or worse urinary toxicity in the ultra-hypofractionation group at end of radiotherapy (158 [28%] of 569 patients vs 132 [23%] of 578 patients; p=0·057). There were no significant differences in grade 2 or worse urinary or bowel late toxicity between the two treatment groups at any point after radiotherapy, except for an increase in urinary toxicity in the ultra-hypofractionation group compared to the conventional fractionation group at 1-year follow-up (32 [6%] of 528 patients vs 13 [2%] of 529 patients; (p=0·0037). We observed no differences between groups in frequencies at 5 years of RTOG grade 2 or worse urinary toxicity (11 [5%] of 243 patients for the ultra-hypofractionation group vs 12 [5%] of 249 for the conventional fractionation group; p=1·00) and bowel toxicity (three [1%] of 244 patients vs nine [4%] of 249 patients; p=0·14). Patient-reported outcomes revealed significantly higher levels of acute urinary and bowel symptoms in the ultra-hypofractionation group compared with the conventional fractionation group but no significant increases in late symptoms were found, except for increased urinary symptoms at 1-year follow-up, consistent with the physician-evaluated toxicity.
INTERPRETATION
Ultra-hypofractionated radiotherapy is non-inferior to conventionally fractionated radiotherapy for intermediate-to-high risk prostate cancer regarding failure-free survival. Early side-effects are more pronounced with ultra-hypofractionation compared with conventional fractionation whereas late toxicity is similar in both treatment groups. The results support the use of ultra-hypofractionation for radiotherapy of prostate cancer.
FUNDING
The Nordic Cancer Union, the Swedish Cancer Society, and the Swedish Research Council.",2019,"There were no significant differences in grade 2 or worse urinary or bowel late toxicity between the two treatment groups at any point after radiotherapy, except for an increase in urinary toxicity in the ultra-hypofractionation group compared to the conventional fractionation group at 1-year follow-up (32 [6%] of 528 patients vs 13 [2%] of 529 patients; (p=0·0037).","['12 centres in Sweden and Denmark, we recruited men up to 75 years of age with intermediate-to-high-risk prostate cancer and a WHO performance status between 0 and 2', 'Between July 1, 2005, and Nov 4, 2015, 1200 patients', '578 patients', 'prostate cancer']","['ultra-hypofractionation', 'conventional fractionated radiotherapy', 'radiotherapy', 'ultra-hypofractionation (42·7', 'conventional fractionation', 'Hypofractionated radiotherapy', 'Ultra-hypofractionated versus conventionally fractionated radiotherapy', 'ultra-hypofractionated radiotherapy']","['grade 2 or worse urinary or bowel late toxicity', 'estimated failure-free survival', 'Prostate Cancer Symptom Scale (PCSS) questionnaire', 'levels of acute urinary and bowel symptoms', 'urinary toxicity', 'Physician-recorded toxicity', 'late symptoms', 'time to biochemical or clinical failure', 'bowel toxicity', 'urinary symptoms', 'late toxicity']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}]",1200.0,0.156199,"There were no significant differences in grade 2 or worse urinary or bowel late toxicity between the two treatment groups at any point after radiotherapy, except for an increase in urinary toxicity in the ultra-hypofractionation group compared to the conventional fractionation group at 1-year follow-up (32 [6%] of 528 patients vs 13 [2%] of 529 patients; (p=0·0037).","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Widmark', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden. Electronic address: anders.widmark@onkologi.umu.se.'}, {'ForeName': 'Adalsteinn', 'Initials': 'A', 'LastName': 'Gunnlaugsson', 'Affiliation': 'Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Beckman', 'Affiliation': 'Department of Oncology, Sundsvall Hospital, Sundsvall, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Thellenberg-Karlsson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hoyer', 'Affiliation': 'Department of Oncology and Danish Centre for Particle Therapy, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Lagerlund', 'Affiliation': 'Department of Oncology, Kalmar Hospital, Kalmar, Sweden.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Kindblom', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ginman', 'Affiliation': 'Department of Oncology, Karlstad Central Hospital, Karlstad, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology, Örebro University Hospital, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Björnlinger', 'Affiliation': 'Department of Oncology, Ryhov Hospital, Jönköping, Sweden.'}, {'ForeName': 'Mihajl', 'Initials': 'M', 'LastName': 'Seke', 'Affiliation': 'Department of Oncology, Centrallasarettet, Växjö, Sweden.'}, {'ForeName': 'Måns', 'Initials': 'M', 'LastName': 'Agrup', 'Affiliation': 'Department of Oncology, Linköping University Hospital, Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Fransson', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Tavelin', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Norman', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Zackrisson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Anderson', 'Affiliation': 'Department of Clinical Sciences Lund, Cancer Epidemiology, Lund University, Lund, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellén', 'Affiliation': 'Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Franzén', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Hematology, Oncology and Radiation Physics, Skåne University Hospital, Lund University, Lund, Sweden.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31131-6']
589,29779700,Plasma Circulating Extracellular RNAs in Left Ventricular Remodeling Post-Myocardial Infarction.,"Despite substantial declines in mortality following myocardial infarction (MI), subsequent left ventricular remodeling (LVRm) remains a significant long-term complication. Extracellular small non-coding RNAs (exRNAs) have been associated with cardiac inflammation and fibrosis and we hypothesized that they are associated with post-MI LVRm phenotypes. RNA sequencing of exRNAs was performed on plasma samples from patients with ""beneficial"" (decrease LVESVI ≥ 20%, n = 11) and ""adverse"" (increase LVESVI ≥ 15%, n = 11) LVRm. Selected differentially expressed exRNAs were validated by RT-qPCR (n = 331) and analyzed for their association with LVRm determined by cardiac MRI. Principal components of exRNAs were associated with LVRm phenotypes post-MI; specifically, LV mass, LV ejection fraction, LV end systolic volume index, and fibrosis. We then investigated the temporal regulation and cellular origin of exRNAs in murine and cell models and found that: 1) plasma and tissue miRNA expression was temporally regulated; 2) the majority of the miRNAs were increased acutely in tissue and at sub-acute or chronic time-points in plasma; 3) miRNA expression was cell-specific; and 4) cardiomyocytes release a subset of the identified miRNAs packaged in exosomes into culture media in response to hypoxia/reoxygenation. In conclusion, we find that plasma exRNAs are temporally regulated and are associated with measures of post-MI LVRm.",2018,Selected differentially expressed exRNAs were validated by RT-qPCR (n = 331) and analyzed for their association with LVRm determined by cardiac MRI.,[],[],"['adverse', 'LV mass, LV ejection fraction, LV end systolic volume index, and fibrosis', 'mortality following myocardial infarction (MI), subsequent left ventricular remodeling (LVRm', 'plasma and tissue miRNA expression']",[],[],"[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0600520', 'cui_str': 'Left Ventricle Remodeling'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.0229155,Selected differentially expressed exRNAs were validated by RT-qPCR (n = 331) and analyzed for their association with LVRm determined by cardiac MRI.,"[{'ForeName': 'Kirsty M', 'Initials': 'KM', 'LastName': 'Danielson', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA; Department of Surgery & Anaesthesia, University of Otago, Wellington 6242, New Zealand.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Yeri', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Camacho Garcia', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Kahraman', 'Initials': 'K', 'LastName': 'Tanriverdi', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA.'}, {'ForeName': 'Avash', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Chunyang', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jerosch-Herold', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Bobak', 'Initials': 'B', 'LastName': 'Heydari', 'Affiliation': 'Division of Cardiology, Department of Cardiac Sciences, University of Calgary, Calgary, Alberta T2N 1N4, Canada.'}, {'ForeName': 'Siddique', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': ""Noninvasive Cardiovascular Imaging Section, Cardiovascular Division, Department of Medicine and Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Kendall', 'Initials': 'K', 'LastName': 'Van Keuren-Jensen', 'Affiliation': 'Neurogenomics Division, Translational Genomics Research Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Freedman', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, University of Massachusetts Medical School, Worcester, MA 01655, USA.'}, {'ForeName': 'Yaoyu E', 'Initials': 'YE', 'LastName': 'Wang', 'Affiliation': 'Dana Farber Cancer Institute Center for Computational Biology, Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Rosenzweig', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA.'}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.""}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Cardiology Division and Corrigan Minehan Heart Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. Electronic address: sdas@mgh.harvard.edu.'}]",EBioMedicine,['10.1016/j.ebiom.2018.05.013']
590,31743998,Effects of a Modified Tai Chi Program on Older People with Mild Dementia: A Randomized Controlled Trial.,"BACKGROUND
Tai Chi exercise is a non-pharmacological therapy that has received increased attention in recent years. A Tai Chi program has been specifically modified for older people with cognitive impairments by the research team.
OBJECTIVE
We aim to assess the effects of this Tai Chi program on mild dementia.
METHODS
Eighty older people with mild dementia were recruited and randomly assigned to a Tai Chi group or a control group. The Tai Chi group practiced the Tai Chi program three times a week for 10 months, while the control group continued receiving routine treatments. All participants were assessed for cognitive function, behavior/mood, and activities of daily living at baseline, 5 months, and 10 months.
RESULTS
The Tai Chi group performed better than the control group. Repeated measures ANOVA revealed a significant group×time interaction in the Montreal Cognitive Assessment (MoCA). Further analysis of sub-items of the MoCA showed a significant time effect in naming and abstraction. It was statistically significant in both main effect of time and group×time interaction in the Neuropsychiatric Inventory (NPI) and Geriatric Depression Scale (GDS). Paired sample t test showed the Tai Chi group scored lower at 5 and 10 months in the NPI and at 10 months in the GDS compared with baseline. The Tai Chi group scored lower than the control group at 10 months in the NPI and GDS.
CONCLUSION
The results suggest this Tai Chi program may help improve cognitive function and mental well-being for older adults with mild dementia.",2019,Paired sample t test showed the Tai Chi group scored lower at 5 and 10 months in the NPI and at 10 months in the GDS compared with baseline.,"['Eighty older people with mild dementia', 'Older People with Mild Dementia', 'older adults with mild dementia', 'mild dementia', 'older people with cognitive impairments']","['control group continued receiving routine treatments', 'Tai Chi exercise', 'Tai Chi program', 'Tai Chi group or a control group', 'Modified Tai Chi Program']","['Neuropsychiatric Inventory (NPI) and Geriatric Depression Scale (GDS', 'cognitive function', 'cognitive function, behavior/mood, and activities of daily living', 'Montreal Cognitive Assessment (MoCA']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C3496286'}]",80.0,0.0516447,Paired sample t test showed the Tai Chi group scored lower at 5 and 10 months in the NPI and at 10 months in the GDS compared with baseline.,"[{'ForeName': 'Nayan', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Xiangjiang', 'Initials': 'X', 'LastName': 'Rong', 'Affiliation': 'School of Kinesiology and Health, Capital University of Physical Education and Sport, Beijing, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Champ', 'Affiliation': 'Department of Nursing and Midwifery, University of the West of England, Bristol, UK.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Graduate School, Capital University of Physical Education and Sport, Beijing, China.'}, {'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Mu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Yueqing', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Zongjuan', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Lyu', 'Affiliation': 'Center for Cognitive Disorders, Beijing Geriatric Hospital, Beijing, China.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-190487']
591,31213063,Predictors and outcomes associated with therapeutic alliance in cognitive behaviour therapy for children with autism.,"Therapeutic alliance is often an important aspect of psychotherapy, though it is rarely examined in clients with autism. This study aims to determine the child pre-treatment variables and treatment outcomes associated with early and late alliance in cognitive behaviour therapy targeting emotion regulation for children with autism. Data were collected from 48 children with autism who participated in a larger randomized-controlled trial. Pre-treatment child characteristics included child, parent, and clinician report of child emotional and behavioural functioning. Primary outcome measures included child and parent-reported emotion regulation. Therapeutic alliance (bond and task-collaboration) was measured using observational coding of early and late therapy sessions. Pre-treatment levels of child-reported emotion inhibition were associated with subsequent early and late bond. Pre-treatment levels of parent and child-reported emotion regulation were related to early and late task-collaboration. Late task-collaboration was also associated with pre-treatment levels of behavioural and emotional symptom severity. Task-collaboration in later sessions predicted improvements in parent-reported emotion regulation from pre- to post-therapy. Future research is needed to further examine the role of task-collaboration as a mechanism of treatment change in therapies for children with autism.",2020,Late task-collaboration was also associated with pre-treatment levels of behavioural and emotional symptom severity.,"['children with autism', 'clients with autism', '48 children with autism who participated in a larger randomized-controlled trial']","['cognitive behaviour therapy targeting emotion regulation', 'cognitive behaviour therapy']","['Therapeutic alliance (bond and task-collaboration', 'child, parent, and clinician report of child emotional and behavioural functioning', 'behavioural and emotional symptom severity', 'emotion regulation', 'emotion inhibition', 'child and parent-reported emotion regulation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C0814487', 'cui_str': 'Therapeutic Alliance'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",48.0,0.0286018,Late task-collaboration was also associated with pre-treatment levels of behavioural and emotional symptom severity.,"[{'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Albaum', 'Affiliation': 'York University, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Tablon', 'Affiliation': 'York University, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Roudbarani', 'Affiliation': 'York University, Canada.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Weiss', 'Affiliation': 'York University, Canada.'}]",Autism : the international journal of research and practice,['10.1177/1362361319849985']
592,31792259,Light therapy with boxes or glasses to counteract effects of acute sleep deprivation.,"Sleep deprivation, in the context of shift work, is an increasing major public health issue. We aimed to determine whether early light administration can counteract sleep deprivation effects, and to compare LED-glasses with a traditional light therapy box. This cross-over design study included 18 individuals exposed to light therapy for 30 minutes at 5 am after one night of complete sleep deprivation, to mimic the night shift condition. Individuals were randomly exposed to 10,000 Lux light box, 2,000 Lux LED blue-enriched glasses, and control (ambient dim-light at 8 lux). Alertness, cognition and mood were assessed throughout the night and following morning. Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation. A rebound was observed at 8 am resulting from the circadian drive overriding cumulative sleep homeostatic effects. Morning light significantly improved sleepiness and sustained attention from 5 to 7 am. These effects were comparable between devices and significantly different from control. Both devices were overall well and similarly tolerated. Early morning light therapy in the condition of sleep loss may have broad practical applications to improve sleepiness, sustained attention and subsequent risk of accidents.",2019,"Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation.","['18 individuals exposed to light therapy for 30\u2009minutes at 5 am after one night of complete sleep deprivation, to mimic the night shift condition', 'Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation']","['Lux light box, 2,000 Lux LED blue-enriched glasses, and control (ambient dim-light at 8 lux']","['sleepiness and sustained attention', 'tolerated', 'Alertness, cognition and mood']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention, function (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",18.0,0.0260985,"Five women and 13 men (mean 24.78 year old) presented with a progressive and increasing alteration of alertness, cognition, and mood during each sleep deprivation.","[{'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Comtet', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France. henri.comtet@chru-strasbourg.fr.""}, {'ForeName': 'Pierre A', 'Initials': 'PA', 'LastName': 'Geoffroy', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Kobayashi Frisk', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hubbard', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Ludivine', 'Initials': 'L', 'LastName': 'Robin-Choteau', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Calvel', 'Affiliation': 'CNRS UPR 3212, Institute for Cellular and Integrative Neurosciences, 8 rue du Général Rouvillois, 67000, Strasbourg, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Hugueny', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Antoine U', 'Initials': 'AU', 'LastName': 'Viola', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Bourgin', 'Affiliation': ""Sleep Disorders Center & CIRCSom (International Research Center for ChronoSomnology), University Hospital, 1 place de l'Hôpital, 67000, Strasbourg, France.""}]",Scientific reports,['10.1038/s41598-019-54311-x']
593,31215092,Effect of vitamin D supplementation on total and free 25 hydroxyvitamin D and parathyroid hormone. An analysis of two randomized controlled trials.,"BACKGROUND
It is questionable as to whether total serum 25 hydroxyvitamin D (T25D) levels are lower in African Americans. We measured serum T25D, free 25hydroxyvitamin D (F25D) and serum parathyroid hormone (PTH) in African American and Caucasian women and studied the effect of vitamin D dosing to determine if differences by race or age occur.
METHODS
Healthy young and older Caucasian and African American women who were vitamin D insufficient were randomized in two clinical trials to escalating daily doses of vitamin D from 400 to 4800 IU and placebo for 12 months.
RESULTS
Baseline F25D and T25D were significantly lower in young but not older African American compared to Caucasian women. At baseline, the rate of change, or slope, in F25D with T25D was significantly greater in younger women than in older women, but difference in the rate of change in F25D with T25D is similar in African American and Caucasian women. After vitamin D supplementation, there was an increase in F25D, and the dose response was not significantly different by age or race. The ratio of F25D/T25D decreased in all groups once T25D exceeded ~60 nmol L -1 . There was a progressive decrease in serum PTH with increasing vitamin D doses and the per cent change was similar for F25D and T25D.
CONCLUSION
Serum F25D and T25D are lower in younger African American women, and since dietary vitamin D is similar in the groups, it is likely that the cause of low serum 25OHD in African American women is due to reduced UV exposure and reduced skin production of vitamin D.",2019,"The ratio of F25D/T25D decreased in all groups once T25D exceeded ~ 60nmol/L. There was a progressive decrease in serum PTH with increasing vitamin D doses and the percent change was similar for F25D and T25D.
CONCLUSION
","['African Americans', 'African American and Caucasian women', 'Healthy young and older Caucasian and African American women who were vitamin D insufficient', 'African American women', 'younger African American women']","['vitamin D', 'vitamin D supplementation', 'Vitamin D Supplementation', 'total serum 25 hydroxyvitamin D', 'vitamin D from 400 IU - 4800IU and placebo']","['F25D, and the dose response', 'Baseline F25D and T25D', 'T25D) levels', 'serum T25D, free 25hydroxyvitamin D (F25D), and serum parathyroid hormone (PTH', 'Total and Free 25 Hydroxyvitamin D and Parathyroid Hormone', 'serum PTH', 'ratio of F25D/T25D', 'Serum F25D and T25D', 'rate of change in F25D with T25D']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0428408', 'cui_str': 'Serum parathyroid hormone measurement'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.198549,"The ratio of F25D/T25D decreased in all groups once T25D exceeded ~ 60nmol/L. There was a progressive decrease in serum PTH with increasing vitamin D doses and the percent change was similar for F25D and T25D.
CONCLUSION
","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Smith', 'Affiliation': 'Department of Biostatistics, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Gallagher', 'Affiliation': 'Bone Metabolism, Department Endocrinology, Creighton University School of Medicine, Omaha, NE, USA.'}]",Journal of internal medicine,['10.1111/joim.12950']
594,31187863,Docosahexaenoic and Arachidonic Acid Supplementation of Toddlers Born Preterm Does Not Affect Short-Term Growth or Adiposity.,"BACKGROUND
Dietary DHA intake among US toddlers is low. Healthy physical growth is an important objective for the clinical care of children born preterm.
OBJECTIVES
The aim of the trial was to examine the effects of supplementing toddlers born preterm with DHA and arachidonic acid (AA) for 180 d on growth and adiposity.
METHODS
Omega Tots, a randomized placebo-controlled trial, was conducted between April 2012 and March 2017. Children born at <35 wk gestation who were 10-16 mo in corrected age were assigned to receive daily oral supplements of DHA and AA (200 mg each, ""DHA + AA"") or corn oil (placebo) for 180 d. Prespecified secondary outcomes included weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage, which were measured at baseline and trial completion. Mixed-effects regression was used to compare the change in outcomes between the DHA + AA and placebo groups, controlling for baseline values.
RESULTS
Among 377 children included in the analysis (median corrected age = 15.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end. No statistically significant differences between the DHA + AA and placebo groups in growth or adiposity outcomes were observed. For instance, the change in weight-for-age z scores was 0.1 for the DHA + AA group and 0.0 for the placebo group (effect size = 0.01, P = 0.99). However, post-hoc subgroup analyses revealed a statistically significant interaction between treatment group and sex, suggesting somewhat slower linear growth for females assigned to the DHA + AA group compared with the placebo group.
CONCLUSIONS
Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo. If DHA supplementation is implemented after the first year of life, it can be expected to have no effect on short-term growth or adiposity. This trial is registered with clinicaltrials.gov as NCT02199808.",2019,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","['Toddlers Born Preterm', 'supplementing toddlers born preterm with DHA and', 'children born preterm', 'Children born at <35 wk gestation who were 10-16 mo in corrected age', '377 children included in the analysis (median corrected age\xa0=\xa015.7 mo, 48.3% female), 348 (92.3%) had growth or adiposity data at baseline and trial end', 'April 2012 and March 2017']","['daily oral supplements of DHA and AA (200 mg each, ""DHA\xa0+\xa0AA"") or corn oil (placebo', 'arachidonic acid (AA', 'placebo', 'Docosahexaenoic and Arachidonic Acid Supplementation']","['weight-for-age z scores', 'growth or adiposity outcomes', 'weight, length, head circumference, mid-upper arm circumference, triceps and subscapular skinfolds, BMI, and their respective z scores, and body fat percentage', 'growth or adiposity']","[{'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0556098', 'cui_str': 'Arachidonic acid supplementation (product)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference (observable entity)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",377.0,0.675973,"Among toddlers born preterm, daily supplementation with DHA + AA for 180 d resulted in no short-term differences in growth or adiposity compared with placebo.","[{'ForeName': 'Taniqua T', 'Initials': 'TT', 'LastName': 'Ingol', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly M', 'Initials': 'KM', 'LastName': 'Boone', 'Affiliation': 'Schoenbaum Family Center and Crane Center for Early Childhood Research and Policy, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rausch', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Klebanoff', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Abigail Norris', 'Initials': 'AN', 'LastName': 'Turner', 'Affiliation': 'Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Keith O', 'Initials': 'KO', 'LastName': 'Yeates', 'Affiliation': ""Department of Psychology, Alberta Children's Hospital Research Institute, and Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.""}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Nelin', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Sheppard', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Keim', 'Affiliation': ""Center for Biobehavioral Health, The Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.""}]",The Journal of nutrition,['10.1093/jn/nxz115']
595,31551368,Potent reduction of plasma lipoprotein (a) with an antisense oligonucleotide in human subjects does not affect ex vivo fibrinolysis.,"It is postulated that lipoprotein (a) [Lp(a)] inhibits fibrinolysis, but this hypothesis has not been tested in humans due to the lack of specific Lp(a) lowering agents. Patients with elevated Lp(a) were randomized to antisense oligonucleotide [IONIS-APO(a) Rx ] directed to apo(a) ( n = 7) or placebo ( n = 10). Ex vivo plasma lysis times and antigen concentrations of plasminogen, factor XI, plasminogen activator inhibitor 1, thrombin activatable fibrinolysis inhibitor, and fibrinogen at baseline, day 85/92/99 (peak drug effect), and day 190 (3 months off drug) were measured. The mean ± SD baseline Lp(a) levels were 477.3 ± 55.9 nmol/l in IONIS-APO(a) Rx and 362.1 ± 89.9 nmol/l in placebo. The mean± SD percentage change in Lp(a) for IONIS-APO(a) Rx was -69.3 ± 12.2% versus -5.4 ± 6.9% placebo ( P < 0.0010) at day 85/92/99 and -15.6 ± 8.9% versus 3.2 ± 12.2% ( P = 0.003) at day 190. Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a) Rx and placebo at all time points. Clot lysis times were not affected by exogenously added Lp(a) at concentrations up to 200 nmol/l to plasma with very low (12.5 nmol/l) Lp(a) levels, whereas recombinant apo(a) had a potent antifibrinolytic effect. In conclusion, potent reductions of Lp(a) in patients with highly elevated Lp(a) levels do not affect ex vivo measures of fibrinolysis; the relevance of any putative antifibrinolytic effects of Lp(a) in vivo needs further study.",2019,Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a)Rx and placebo at all timepoints.,"['patients with highly elevated Lp(a) levels', 'lipoprotein(a) [Lp(a', 'Patients with elevated Lp(a', 'human subjects']","['placebo', 'Lp(a', 'antisense oligonucleotide (IONIS-APO(a)Rx) directed to apolipoprotein(a']","['Clot lysis times and coagulation/fibrinolysis-related biomarkers', 'Lp(a', 'mean (SD) percent change in Lp(a', 'Clot lysis times', 'plasma lipoprotein(a', 'Ex vivo plasma lysis times and antigen concentrations of plasminogen, factor XI, PAI-1, TAFI, and fibrinogen', 'mean (SD) baseline Lp(a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079925', 'cui_str': 'Anti-Sense Oligonucleotides'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0200464', 'cui_str': 'Clot Lysis Time'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032140', 'cui_str': 'Profibrinolysin'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",200.0,0.129998,Clot lysis times and coagulation/fibrinolysis-related biomarkers showed no significant differences between IONIS-APO(a)Rx and placebo at all timepoints.,"[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Boffa', 'Affiliation': 'Department of Biochemistry Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Tanya T', 'Initials': 'TT', 'LastName': 'Marar', 'Affiliation': 'Department of Biochemistry Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Yeang', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Viney', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Witztum', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Marlys L', 'Initials': 'ML', 'LastName': 'Koschinsky', 'Affiliation': 'Robarts Research Institute, Schulich School of Medicine & Dentistry, The University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsimikas', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, La Jolla, CA stsimikas@ucsd.edu.'}]",Journal of lipid research,['10.1194/jlr.P094763']
596,31564057,Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials.,"BACKGROUND
Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13. International phase II and III studies have evaluated the efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis (AD), but the effects of dupilumab in Japanese patients have not been reported.
OBJECTIVES
To evaluate the efficacy and safety of dupilumab in Japanese patients with moderate-to-severe AD.
METHODS
We analysed the efficacy and safety of dupilumab in the Japanese cohorts of a 16-week, phase IIb dose-finding trial (AD-1021; NCT01859988); a 16-week, phase III, placebo-controlled monotherapy trial (LIBERTY AD SOLO 1; NCT02277743) and a 52-week, phase III, placebo-controlled study of dupilumab with topical corticosteroids (LIBERTY AD CHRONOS; NCT02260986).
RESULTS
Twenty-seven, 106 and 117 Japanese patients were enrolled in AD-1021, SOLO 1 and CHRONOS, respectively. Baseline disease severity was numerically higher in the Japanese cohort than in the overall study population. Generally, dupilumab significantly improved signs and symptoms of AD, including pruritus and patient quality of life, compared with placebo in the Japanese cohort, consistent with the overall study population. The combined safety profile of dupilumab in the Japanese cohort was similar to that in the total study populations; dupilumab was associated with an increased incidence of injection-site reactions and conjunctivitis compared with placebo. Dupilumab was associated with rapid reduction in thymus and activation-regulated chemokine and gradual IgE reductions.
CONCLUSIONS
Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD, had an acceptable safety profile, and suppressed biomarkers of type 2 inflammation compared with placebo in Japanese adult patients with moderate-to-severe AD. What's already known about this topic? Differences in atopic dermatitis (AD) pathology have been reported between Asian and Western populations, in which distinct helper T-cell activation profiles have been observed. International clinical studies in adults with moderate-to-severe AD have evaluated the efficacy and safety of dupilumab, which blocks interleukin-4 and interleukin-13, key molecules in type 2 inflammation. The effects of dupilumab in Japanese patients specifically have not yet been reported. What does this study add? Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD and had an acceptable safety profile compared with placebo in Japanese patients with moderate-to-severe AD. The effects were comparable with those observed in the overall study population. Reported immunological differences in AD pathology in Asian patients may be secondary to type 2 immune activation.",2020,"BACKGROUND
Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13.","['Japanese adults with moderate-to-severe atopic dermatitis', 'Twenty-seven, 106, and 117 Japanese patients enrolled in AD-1021, SOLO 1 and CHRONOS, respectively', 'adults with moderate-to-severe atopic dermatitis (AD', 'Japanese adult patients with moderate-to-severe AD', 'Japanese patients with moderate-to-severe AD']","['placebo-controlled monotherapy', 'dupilumab with topical corticosteroids (TCS, LIBERTY AD', 'placebo', 'Dupilumab alone or with TCS', 'dupilumab']","['Baseline disease severity', 'efficacy and safety', 'signs and symptoms of AD, including pruritus, and patient quality of life', 'Efficacy and safety']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}]",117.0,0.0559352,"BACKGROUND
Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katoh', 'Affiliation': 'Department of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Dermatology, Osaka Habikino Medical Center, Osaka, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Etoh', 'Affiliation': 'Department of Dermatology, Tokyo Teishin Postal Services Agency Hospital, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Imafuku', 'Affiliation': 'Department of Dermatology, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Department of Dermatology, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ohtsuki', 'Affiliation': 'Department of Dermatology, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Arima', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Takagi', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18565']
597,31785587,Kinetics of oxytocin effects on amygdala and striatal reactivity vary between women and men.,"Accumulating evidence suggests that intranasal oxytocin (OXT; 24 IU) reduces amygdala responses to fear-related stimuli in men, while exerting inverse effects in women. However, OXT enhances activity of the brain reward system in both sexes. Importantly, a crucial and still open question is whether there are sex-specific dose-response relationships for the amygdala and striatal regions. To address this question, a total of 90 healthy women participated in a double-blind, placebo-controlled crossover functional magnetic resonance imaging (fMRI) study and the results were compared with our previous findings from men. Participants were randomly assigned to three doses of OXT (6 IU, 12 IU, and 24 IU) and completed an emotional face recognition task including fearful and happy faces of varying emotional intensities. Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women. While treatment effects on amygdala reactivity were evident at each given dose, the OXT effect on striatal responses to social stimuli was more pronounced with higher doses, but this dose-dependent effect did not survive correction for multiple comparisons. Importantly, OXT effects on amygdala and striatal activation significantly differed between sexes and striatal baseline sexual-dimorphic response patterns were diminished after administration of OXT. Our findings suggest that OXT increases the salience of social signals by strengthening the sensitivity for these signals in the amygdala and in the striatum in women, while OXT may primarily induce anxiolysis by reducing amygdala responses in men.",2020,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","['90 healthy women participated in a double-blind', 'women and men']","['OXT', 'placebo-controlled crossover functional magnetic resonance imaging (fMRI', 'oxytocin', 'intranasal oxytocin (OXT', 'placebo', 'emotional face recognition task including fearful and happy faces of varying emotional intensities']","['amygdala reactivity', 'amygdala and striatal reactivity', 'OXT effects on amygdala and striatal activation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",90.0,0.234159,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lieberz', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany. Dirk-Scheele@gmx.de.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Institute for Psychology, University of Freiburg, 79104, Freiburg, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Matheisen', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Lìa', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kinfe', 'Affiliation': 'Department of Neurosurgery, Division of Functional Neurosurgery and Stereotaxy, Friedrich-Alexander University (FAU) Erlangen-Nürnberg, 91054, Erlangen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0582-6']
598,31904841,Patients' Experiences with Telecare for Chronic Pain and Mood Symptoms: A Qualitative Study.,"OBJECTIVE
Pain, anxiety, and depression commonly co-occur, can have reciprocal effects, and are associated with substantial disability and health care costs. However, few interventions target treatment of pain and mood disorders as a whole. The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial was a randomized trial comparing two pragmatic telecare interventions, a high- vs low-resource approach to pain and anxiety/depression treatment. The purpose of the current study is to better understand patients' perspectives on both intervention approaches, including intervention components, delivery, patient experiences, and patient outcomes.
DESIGN
Qualitative, semistructured interviews.
SETTING
A Veterans Affairs Medical Center.
SUBJECTS
Twenty-five patients were purposefully sampled from both study arms.
METHODS
Patients were interviewed about their experiences with pain and mood treatment, perceived benefits and changes, and experiences with the intervention model to which they were randomized. The constant comparison method guided analysis.
RESULTS
Pain was more important than mood for most participants. Participants described developing increased awareness of their symptoms, including connecting pain and mood, which enabled better management. Participants in the high-resource intervention described the added value of the study nurse in their symptom management.
CONCLUSIONS
Patients in a telecare intervention for chronic pain and mood symptoms learned to connect pain and mood and be more aware of their symptoms, enabling more effective symptom management. Patients in the high-resource intervention described the added benefits of a nurse who provided informational and motivational support. Implications for tradeoffs between resource intensity and patient outcomes are discussed.",2020,"The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial was a randomized trial comparing two pragmatic telecare interventions, a high- vs low-resource approach to pain and anxiety/depression treatment.","[""Patients' Experiences with Telecare for Chronic Pain and Mood Symptoms"", 'Twenty-five patients were purposefully sampled from both study arms', 'Patients were interviewed about their experiences with pain and mood treatment, perceived benefits and changes, and experiences with the intervention model to which they were randomized', 'A Veterans Affairs Medical Center']","['high- vs low-resource approach', 'telecare intervention']",['pain and mood disorders'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}]",25.0,0.0597644,"The Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) trial was a randomized trial comparing two pragmatic telecare interventions, a high- vs low-resource approach to pain and anxiety/depression treatment.","[{'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Matthias', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'McCalley', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, Indiana.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz345']
599,31657594,The impact of nicotine dose and instructed dose on smokers' implicit attitudes to smoking cues: An ERP study.,"It is unclear whether nicotine and perceived nicotine exposure can influence automatic evaluations of cigarette stimuli. In the present study, we investigated the effects of nicotine dose and instructed dose on motivational responses to smoking cues. Forty overnight nicotine-deprived smokers completed an Implicit Association Test (IAT) at each of the four laboratory sessions in a balanced-placebo design that crossed nicotine dose (Given-NIC [given nicotine] vs. Given-DENIC [given denicotinized]) with instructed dose expectancy (Told-NIC [told-nicotine] vs. Told-DENIC. [told-denicotinized]). We measured participants' behavioral performance, including reaction time (RT) and accuracy rate, and the early posterior negativity (EPN) component using the event-related potential (ERP) technique to the target pictures. During congruent trials when the categorization condition was smoking or unpleasant, smokers had greater classification accuracy, shorter RT latency, and greater EPN amplitudes compared to the incongruent trials when the categorization condition was smoking or pleasant. The Given-NIC condition was associated with increased classification accuracy, longer RT latency, and decreased EPN amplitudes compared to the Given-DENIC condition. Similarly, the Told-NIC condition was associated with increased accuracy and decreased EPN amplitudes compared to the Told-DENIC condition, but with shorter RT latency. Cigarette-related pictures produced greater EPN amplitudes than neutral pictures. Both behavioral and ERP results suggest that smokers have negative implicit attitudes toward smoking. While both nicotine dose and expected dose facilitated stimulus categorization, there was no evidence that either factor altered smokers' negative attitudes toward smoking cues. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"During congruent trials when the categorization condition was smoking or unpleasant, smokers had greater classification accuracy, shorter RT latency, and greater EPN amplitudes compared to the incongruent trials when the categorization condition was smoking or pleasant.","[""smokers' implicit attitudes to smoking cues""]","['Forty overnight nicotine-deprived smokers completed an Implicit Association Test (IAT', 'nicotine dose (Given-NIC [given nicotine] vs. Given-DENIC [given denicotinized]) with instructed dose expectancy (Told-NIC [told-nicotine] vs. Told-DENIC', 'nicotine']","['accuracy and decreased EPN amplitudes', 'classification accuracy, longer RT latency, and decreased EPN amplitudes', 'EPN amplitudes', 'behavioral performance, including reaction time (RT) and accuracy rate, and the early posterior negativity (EPN) component using the event-related potential (ERP) technique to the target pictures', 'classification accuracy, shorter RT latency, and greater EPN amplitudes']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0014614', 'cui_str': 'O-Ethyl-O-(4-nitrophenyl)phenylphosphonothioate'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]",2019.0,0.0114723,"During congruent trials when the categorization condition was smoking or unpleasant, smokers had greater classification accuracy, shorter RT latency, and greater EPN amplitudes compared to the incongruent trials when the categorization condition was smoking or pleasant.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Behavioral Science.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Engelmann', 'Affiliation': 'Department of Behavioral Science.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Waters', 'Affiliation': 'Uniformed Services University of the Health Sciences.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Cinciripini', 'Affiliation': 'Department of Behavioral Science.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Behavioral Science.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000523']
600,31773430,Correction to: Web-Based Intervention and Email‑Counseling for Problem Gamblers: Results of a Randomized Controlled Trial.,"The article ""Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial"" was written by Benjamin Jonas, Fabian Leuschner, Anna Eiling, Christine Schoelen, Renate Soellner and Peter Tossmann.",2020,"The article ""Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial"" was written by Benjamin Jonas, Fabian Leuschner, Anna Eiling, Christine Schoelen, Renate Soellner and Peter Tossmann.",['Problem Gamblers'],"['Correction to: Web-Based Intervention and Email‑Counseling', 'Web-Based Intervention and Email-Counseling']",[],"[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",[],,0.11313,"The article ""Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial"" was written by Benjamin Jonas, Fabian Leuschner, Anna Eiling, Christine Schoelen, Renate Soellner and Peter Tossmann.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Jonas', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany. jonas@delphi.de.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Leuschner', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eiling', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schoelen', 'Affiliation': 'Federal Centre for Health Education (BZgA), Cologne, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Soellner', 'Affiliation': 'University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tossmann', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}]",Journal of gambling studies,['10.1007/s10899-019-09914-4']
601,31776620,Impact of per-operative antibiotics on the urinary tract infection rate following mid-urethral sling surgery for urinary incontinence: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS
The objective was to compare the effect of antibiotics versus no antibiotics prophylaxis per-operatively on the frequency of urinary tract infection (UTI) following mid-urethral sling application to treat stress or mixed urinary incontinence.
METHODS
This study was designed as a multicenter prospective randomized trial. Women were included from eight centers in three countries. Women were aged under 60 years and had objectively verified stress urinary incontinence. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either antibiotics or no antibiotics. UTI was defined in accordance with the Centers for Disease Control (CDC) criteria for symptomatic UTI. Women were followed up at 3, 12, and 36 months. This was part of a trial comparing subjective cure rate in relation to application of Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings.
RESULTS
The main outcome was to evaluate if per-operative antibiotics had any impact on UTI following sling surgery. In total, 305 women were randomized (158 [52%] to antibiotics and 147 [48%] to no antibiotics). Demographic data disclosed no differences between the two groups. The trial did not show any difference between the two groups regarding the frequency of postoperative UTI. Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs. Per-operative antibiotics had no influence on the frequency of mesh erosions or any other complication.
CONCLUSIONS
Our trial does not suggest any beneficial effect of per-operative antibiotics on the risk of post-operative UTIs.",2020,Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs.,"['Women with mixed urinary incontinence', 'urinary incontinence', 'Women were aged under 60\xa0years and had objectively verified stress urinary incontinence', 'Women were included from eight centers in three countries', '305 women']","['mid-urethral sling surgery', 'antibiotics', 'per-operative antibiotics', 'Ajust® (single-incision mid-urethral slings) versus standard mid-urethral slings']","['frequency of urinary tract infection (UTI', 'urinary tract infection rate', 'frequency of postoperative UTI', 'frequency of mesh erosions']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0869256', 'cui_str': 'Mixed incontinence (finding)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}]","[{'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}]",305.0,0.165136,Logistic regression analysis disclosed only residual urine volume at 3 months' follow-up as a significant risk factor for UTIs.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rudnicki', 'Affiliation': 'Department of Obstetrics and Gynecology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense, Denmark. mr@rsyd.dk.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Jakobsson', 'Affiliation': 'Center for Primary Healthcare Research, Clinical Research Center, Box 50332, 202 13, Malmö, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Teleman', 'Affiliation': 'Department of Obstetrics and Gynecology, Skane University Hospital, Lund University, Klinikgatan 12, 221 85, Lund, Sweden.'}]",International urogynecology journal,['10.1007/s00192-019-04156-9']
602,31738072,Improvement in women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder.,"The cardiovascular system is disrupted by chronic excessive alcohol use and often impaired in individuals with an alcohol use disorder (AUD). Less is known about cardiovascular recovery when an individual receives treatment for AUD. This observational study aimed to extend the growing body of evidence for cardiovascular biomarkers and intervention targets in the treatment of AUD. We examined cardiovascular function in 92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD. Participants were recruited exclusively from a randomized clinical trial comparing group versus individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available. Demographic and drinking data were obtained from the parent study. Cardiovascular data were collected as part of this separate study, prior to and following the clinical trial. Mixed-model analyses revealed multiple within-person cardiovascular changes indicative of improving health from pre- to posttreatment, including reduced heart rate and vessel stiffness as well as increased heart rate variability and baroreflex sensitivity. These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions. Future studies should assess the time course of cardiovascular recovery during addiction treatment and the mechanisms by which evidence-based AUD treatments may benefit physical as well as mental health. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","['individuals with an alcohol use disorder (AUD', ""women's cardiovascular functioning during cognitive-behavioral therapy for alcohol use disorder"", '92 women before and after 12 weeks of cognitive-behavioral therapy (CBT) for AUD']","['individual CBT treatment strategies (parent study); no control group of untreated, but treatment-seeking women was available']","['heart rate variability and baroreflex sensitivity', 'heart rate and vessel stiffness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}]",2019.0,0.0455963,"These significant improvements remained when extent of drinking during treatment was included in the models, suggesting that active ingredients of AUD treatment may serve to benefit physical health over and above drinking reductions.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Buckman', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Evgeny G', 'Initials': 'EG', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Epstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Tam T', 'Initials': 'TT', 'LastName': 'Nguyen-Louie', 'Affiliation': 'SDSU/UCSD Joint Doctoral Program in Clinical Psychology.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Lesnewich', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Eddie', 'Affiliation': 'Massachusetts General Hospital.'}, {'ForeName': 'Marsha E', 'Initials': 'ME', 'LastName': 'Bates', 'Affiliation': 'Department of Kinesiology and Health.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000524']
603,31155969,Cognitive oriented strategy training augmented rehabilitation (COSTAR) for ischemic stroke: a pilot exploratory randomized controlled study.,"Purpose: To investigate the effect of adding cognitive strategy training to task-specific training (TST), called Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR), compared with TST on activity and participation for chronic stroke survivors in an outpatient occupational therapy setting Materials and methods: We conducted an exploratory, single-blind, randomized controlled trial. Participants were randomized to TST or COSTAR protocol. Our primary outcomes measured activity and participation after stroke: the Stroke Impact Scale (SIS), Canadian Occupational Performance Measure (COPM), and Performance Quality Rating Scale (PQRS). Results: Forty-four participants were randomized. The COSTAR group had an attrition rate of 50% and an average of 9.8 of 12 sessions were completed; the TST group had an attrition rate of 25% and an average of 10.7 sessions were completed. Generally both groups improved on the majority of primary and secondary outcomes. There is little evidence to support a beneficial effect of COSTAR over TST for improvement of primary measures of activity performance or secondary measures. Conclusion: Negligible findings may be attributed to an inadvertent treatment group equivalency. Further, the research design did not allow for adequate measurement of the effect of each intervention on participants' ability to generalize learned skills. Implications for rehabilitation Stroke rehabilitation is largely based upon the principles of task-specific training, which is associated with improvements in upper extremity motor performance; however, TST requires a heavy dosage and lacks generalization to untrained activities. Cognitive strategy use has been associated with improved generalization of treatment to untrained activities and novel contexts however, it is often not used in TST protocols. The results of this preliminary study found no clear advantage between task-specific training and strategy-adapted task-specific training on trained and untrained activities when both interventions targeted activity performance. Task-specific training, if focused at the activity performance level rather than the impairment reduction level, may have a stronger effect on improving in individual's ability to participate in everyday life activities even without the use of cognitive-strategies. Incorporating cognitive strategy-use into TST would likely produce the greatest effect on generalization and transfer of the treatment effects to other activities and contexts rather than solely on activity performance of trained activities.",2019,The results of this preliminary study found no clear advantage between task-specific training and strategy-adapted task-specific training on trained and untrained activities when both interventions targeted activity performance.,"['ischemic stroke', 'chronic stroke survivors in an outpatient occupational therapy setting Materials and methods', 'Results: Forty-four participants were randomized']","['Cognitive oriented strategy training augmented rehabilitation (COSTAR', 'TST', 'Task-specific training', 'cognitive strategy training to task-specific training (TST), called Cognitive Oriented Strategy Training Augmented Rehabilitation (COSTAR']","['attrition rate', 'activity and participation after stroke: the Stroke Impact Scale (SIS), Canadian Occupational Performance Measure (COPM), and Performance Quality Rating Scale (PQRS', 'activity performance']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",44.0,0.055322,The results of this preliminary study found no clear advantage between task-specific training and strategy-adapted task-specific training on trained and untrained activities when both interventions targeted activity performance.,"[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wolf', 'Affiliation': 'a Department of Occupational Therapy , University of Missouri , Columbia , MO , USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'b Department of Occupational Science and Occupational Therapy , Saint Louis University , St. Louis , MO , USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Boone', 'Affiliation': 'a Department of Occupational Therapy , University of Missouri , Columbia , MO , USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Rios', 'Affiliation': ""c Sunnybrook Research Institute , St. John's Rehab Program , Toronto , Canada.""}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Polatajko', 'Affiliation': 'd Department of Occupational Science and Occupational Therapy , University of Toronto , Toronto , Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Baum', 'Affiliation': 'e Program in Occupational Therapy , Washington University School of Medicine , St. Louis , MO , USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'McEwen', 'Affiliation': ""c Sunnybrook Research Institute , St. John's Rehab Program , Toronto , Canada.""}]",Disability and rehabilitation,['10.1080/09638288.2019.1620877']
604,31764271,Implementation Science Using Proctor's Framework and an Adaptation of the Multiphase Optimization Strategy: Optimizing a Financial Incentive Intervention for HIV Treatment Adherence in Tanzania.,"BACKGROUND
Ambitious targets have been set to end the HIV epidemic by 2030. Such targets assume that tools to end HIV exist and are successfully being deployed across populations, albeit unequally. Implementation science approaches are needed to understand the drivers of disparities and how to bring effective interventions to those most in need. We describe a hybrid implementation science approach, adapting a strategy to facilitate retention and viral suppression (VS) among people living with HIV/AIDS in Tanzania.
METHODS/DESIGN
We used Proctor framework and the multiphase optimization strategy to optimize a cash transfer to improve antiretroviral therapy adherence and VS among people living with HIV/AIDS in Tanzania. This involved 3 trials. The first trial tested the efficacy of cash and food assistance compared with the standard of care in improving antiretroviral therapy adherence among treatment initiators. Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food. The second trial is dose-finding: identifying the optimal amount of cash for a 20% improvement in VS at 6 months. Before this, components were simplified to maximize reach, align with local policies, and reduce staff time. We assessed implementation science constructs to understand barriers to uptake and sustainability. Trial 3 is a cluster randomized controlled trial, testing the effectiveness of the optimized intervention in multiple settings.
DISCUSSION/IMPLICATIONS
Our process illustrates the utility of applying multiple implementation science frameworks to arrive at an optimal implementation strategy to bridge the know-do gap with data to show efficacy and maximum potential for scalability and sustainability.",2019,"Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food.","['people living with HIV/AIDS in Tanzania', 'HIV Treatment Adherence in Tanzania']","['Financial Incentive Intervention', 'cash and food assistance']",[],"[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C3494395', 'cui_str': 'Food Assistance'}]",[],,0.109746,"Cash transfers were superior to the standard of care and noninferior, less expensive, and logistically simpler to implement compared with food.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Packel', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Fahey', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}, {'ForeName': 'Prosper', 'Initials': 'P', 'LastName': 'Njau', 'Affiliation': 'Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Sandra I', 'Initials': 'SI', 'LastName': 'McCoy', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, Berkeley, School of Public Health, Berkeley, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002196']
605,31560101,Web-Based Intervention and Email-Counseling for Problem Gamblers: Results of a Randomized Controlled Trial.,"Web-based interventions have the potential to reduce the treatment gap for problem gambling. In the past years, several web-based help options were made available to the public. However, only few studies were conducted to test their effects. This study investigated the efficacy of two interventions for problem gamblers provided online by the German Federal Center for Health Education (BZgA). The first intervention is the guided program ""Check Out"" (CO), the second is email counselling (EC). A web-based randomized controlled trial with follow-up surveys after 3, 6 and 12 months was conducted. Participants were allocated to CO, to EC or to a waitlist (WL). Outcomes were the degree of problem gambling according to the Problem Gambling Severity Index, the number of days gambled in past 30 days, the highest stake during the past 30 days and the subjective well-being (WHO-5). 167 individuals were included in the trial. In comparison to the WL at the 3 months follow-up, participants of CO showed significant improvements with moderate to strong effect sizes in all outcomes. Strongest effects were found in the problem gambling severity (d = 0.91; p = 0.023), followed by the well-being (d = 0.70; p = 0.011), the gambling days (d = 0.59; p = 0.001) and the highest stake (d = 0.55; p = 0.012). Improvements were sustained until last follow-up. Compared to the WL, users of EC had beneficiary results in the problem gambling severity (d = 0.74; p = 0.022). No significant effect differences were found between CO and EC. However, according to process evaluation, users of CO reported a significantly stronger working alliance than users of EC (d = 0.70; p = 0.019) and used the intervention considerably longer (d = 0.84; p = 0.004). CO helps treatment-seeking individuals to sustainably reduce their gambling behavior and to increase their general well-being. Compared to EC, CO seems a better support option, since its effects include a wider range of outcomes. Possible reasons are the more engaging program structure and elements of CO, as well as the closer interaction between client and counselor.",2020,"Strongest effects were found in the problem gambling severity (d = 0.91; p = 0.023), followed by the well-being (d = 0.70; p = 0.011), the gambling days (d = 0.59; p = 0.001) and the highest stake (d = 0.55; p = 0.012).","['167 individuals were included in the trial', 'problem gamblers provided online by the German Federal Center for Health Education (BZgA', 'Problem Gamblers']","['CO', 'Web-Based Intervention and Email-Counseling', 'guided program ""Check Out"" (CO), the second is email counselling (EC', 'CO, to EC or to a waitlist (WL']","['problem gambling severity', 'stronger working alliance', 'degree of problem gambling according to the Problem Gambling Severity Index, the number of days gambled in past 30\xa0days, the highest stake during the past 30\xa0days and the subjective well-being (WHO-5', 'gambling behavior']","[{'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",167.0,0.0467556,"Strongest effects were found in the problem gambling severity (d = 0.91; p = 0.023), followed by the well-being (d = 0.70; p = 0.011), the gambling days (d = 0.59; p = 0.001) and the highest stake (d = 0.55; p = 0.012).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Jonas', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany. jonas@delphi.de.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Leuschner', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eiling', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schoelen', 'Affiliation': 'Federal Centre for Health Education (BZgA), Cologne, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Soellner', 'Affiliation': 'University of Hildesheim, Hildesheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Tossmann', 'Affiliation': 'Delphi - Gesellschaft für Forschung, Beratung und Projektentwicklung mbH, Kaiserdamm 8, 14057, Berlin, Germany.'}]",Journal of gambling studies,['10.1007/s10899-019-09883-8']
606,31788913,Genetic counselor and proxy patient perceptions of genetic counselor responses to prenatal patient self-disclosure requests: Skillfulness is in the eye of the beholder.,"Research demonstrates some genetic counselors self-disclose while others do not when patients' request self-disclosure. Limited psychotherapy research suggests skillfulness matters more than type of counselor response. This survey research assessed perceived skillfulness of genetic counselor self-disclosures and non-disclosures. Genetic counselors (n = 147) and proxy patients, women from the public (n = 201), read a hypothetical prenatal genetic counseling scenario and different counselor responses to the patient's question, What would you do if you were me? Participants were randomized either to a self-disclosure study (Study 1) or non-disclosure study (Study 2) and, respectively, rated the skillfulness of five personal disclosures and five professional disclosures or five decline to disclose and five redirecting non-disclosures. Counselor responses in both studies varied by intention (corrective, guiding, interpretive, literal, or reassuring). Participants also described what they thought made a response skillful. A three-way mixed ANOVA in both studies analyzed skillfulness ratings as a function of sample (proxy patient, genetic counselor), response type (personal, professional self-disclosure, or redirecting, declining non-disclosure), and response intention. Both studies found a significant three-way interaction and strong main effect for response intention. Responses rated highest in skillfulness by both genetic counselors and proxy patients in Study 1 were a guiding personal self-disclosure and a personal reassuring self-disclosure. The response rated highest in skillfulness by both samples in Study 2 was a redirecting non-disclosure with a reassuring intention. Proxy patients in both studies rated all literal responses as more skillful than genetic counselors. Participants' commonly described a skillful response as offering guidance and/or reassurance. Counselor intentions and response type appear to influence perceptions, and counselors and patients may not always agree in their perceptions. Consistent with models of practice (e.g., Reciprocal-Engagement Model), genetic counselors generally should aim to convey support and guidance in their responses to prenatal patient self-disclosure requests.",2020,"Participants were randomized either to a self-disclosure study (Study 1) or non-disclosure study (Study 2) and, respectively, rated the skillfulness of five personal disclosures and five professional disclosures or five decline to disclose and five redirecting non-disclosures.","['Genetic counselors (n\xa0=\xa0147) and proxy patients, women from the public (n\xa0=\xa0201']",['personal disclosures and five professional disclosures or five decline to disclose and five redirecting non-disclosures'],['Counselor responses'],"[{'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C1571885', 'cui_str': 'Counselors'}]",,0.0322009,"Participants were randomized either to a self-disclosure study (Study 1) or non-disclosure study (Study 2) and, respectively, rated the skillfulness of five personal disclosures and five professional disclosures or five decline to disclose and five redirecting non-disclosures.","[{'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Greve', 'Affiliation': 'HudsonAlpha Institute for Biotechnology, Huntsville, AL, USA.'}, {'ForeName': 'Patricia McCarthy', 'Initials': 'PM', 'LastName': 'Veach', 'Affiliation': 'Department of Genetics, Cell Biology, and Development, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'LeRoy', 'Affiliation': 'Department of Genetics, Cell Biology, and Development, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'MacFarlane', 'Affiliation': 'Department of Psychology, Elizabethtown College, Elizabethtown, PA, USA.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Redlinger-Grosse', 'Affiliation': 'Department of Genetics, Cell Biology, and Development, University of Minnesota, Minneapolis, MN, USA.'}]",Journal of genetic counseling,['10.1002/jgc4.1190']
607,31201426,The Impact of Learning Multiple Real-World Skills on Cognitive Abilities and Functional Independence in Healthy Older Adults.,"OBJECTIVE
The natural learning experience from infancy to emerging adulthood, when considerable cognitive and functional growth is observed, mandates learning multiple real-world skills simultaneously. The present studies investigated whether learning multiple real-world skills simultaneously is possible in older adults and also whether it improves both their cognitive abilities (working memory, episodic memory, and cognitive control) and functional independence.
METHOD
Over two studies (15 and 27 participants), older adults learned at least three new skills (e.g., Spanish, drawing, music composition) simultaneously for 3 months. Participants completed cognitive and functional assessments before, during, and after the intervention in both studies. Participants were recruited sequentially for an intervention or no-contact control group in Study 1, and Study 2 included only an intervention group, who also completed assessments 4-6 weeks prior to the start of the intervention (i.e., they served as their own control group).
RESULTS
Results from both studies show that simultaneously learning multiple skills is feasible and potentially beneficial for healthy older adults. Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults, 30 years younger.
DISCUSSION
Our findings demonstrate the feasibility and potential of conducting a real-world skill-learning intervention involving learning three novel skills with older adults. Our multiskill intervention may provide broad cognitive gains, akin to the benefits experienced earlier in the life span.",2020,"Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults.
","['healthy older adults', 'middle-aged adults', 'older adults']","['intervention or no-contact control', 'learning multiple real-world skills', 'real-world skill learning intervention']","['cognitive abilities (working memory, episodic memory, and cognitive control) and functional independence', 'cognitive abilities', 'cognitive abilities and functional independence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",3.0,0.0257695,"Learning multiple skills simultaneously increased cognitive abilities in older adults by midpoint of the intervention, to levels similar to performance in a separate sample of middle-aged adults.
","[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Leanos', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Kürüm', 'Affiliation': 'Department of Statistics, University of California, Riverside.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Strickland-Hughes', 'Affiliation': 'Department of Psychology, University of the Pacific, Sacramento, California.'}, {'ForeName': 'Annie S', 'Initials': 'AS', 'LastName': 'Ditta', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Gianhu', 'Initials': 'G', 'LastName': 'Nguyen', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Felix', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'Hara', 'Initials': 'H', 'LastName': 'Yum', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Bloomberg School of Public Health and Johns Hopkins Center on Aging and Health, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychology, University of California, Riverside.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbz084']
608,31773199,Bowel preparation prior to minimally invasive sacrocolpopexy: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS
The objective was to determine if a bowel preparation prior to minimally invasive sacrocolpopexy (MIS) influences post-operative constipation symptoms. We hypothesized that women who underwent a bowel preparation would have an improvement in post-operative defecatory function.
METHODS
In this randomized controlled trial, women undergoing MIS received a pre-operative bowel preparation or no bowel preparation. Our primary outcome was post-operative constipation measured by the Patient Assessment of Constipation Symptoms (PAC-SYM) 2 weeks post-operatively. Secondary outcomes included surgeon's perception of case difficulty. Both intention-to-treat (ITT) and per-protocol analyses (PPA) were performed. Analyses were carried out using t test, Fisher's exact test, the Wilcoxon test and the Chi-squared test.
RESULTS
Of 105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation). Baseline characteristics and rates of complications were similar. No differences were noted on ITT. The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08, p = 0.045). Women who underwent a preparation were less likely to report strain (6.0% vs 26.7%, p = 0.009) or type 1 Bristol stool on their first post-operative bowel movement (4.3% vs 17.5%, p = 0.047). Surgeons were more likely to rate the complexity of the case as ""more difficult than average"" (54.4% vs 40.1%, p = 0.027) in those without a bowel preparation.
CONCLUSIONS
Although there was no difference in ITT analysis, women who underwent a bowel preparation prior to MIS demonstrated benefit to post-operative defecatory function with a corresponding improvement in surgeon's perception of case complexity.",2020,"The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08,","['105 enrolled women, 95 completed follow-up (43 preparation and 52 no preparation', 'women undergoing MIS']","['minimally invasive sacrocolpopexy (MIS', 'Bowel preparation prior to minimally invasive sacrocolpopexy', 'pre-operative bowel preparation or no bowel preparation']","['report strain', ""surgeon's perception of case difficulty"", 'Baseline characteristics and rates of complications', 'ITT', 'post-operative abdominal PAC-SYM subscale', 'Constipation Symptoms (PAC-SYM', 'post-operative constipation']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0554325', 'cui_str': 'Sacrocolpopexy (procedure)'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",105.0,0.298916,"The post-operative abdominal PAC-SYM subscale was closer to baseline for women who received a bowel preparation on PPA (change in score 0.74 vs 1.08,","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA, 15218, USA. sassanijc@upmc.edu.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Kantartzis', 'Affiliation': 'Banner University Medical Center, University of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Liwen', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fabio', 'Affiliation': 'Epidemiology Data Center, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Halina M', 'Initials': 'HM', 'LastName': 'Zyczynski', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Magee-Womens Hospital, 300 Halket Street, Pittsburgh, PA, 15218, USA.'}]",International urogynecology journal,['10.1007/s00192-019-04120-7']
609,31781880,Salvage of the retinal ganglion cells in transition phase in Alzheimer's disease with topical coenzyme Q10: is it possible?,"PURPOSE
The evaluation of the short-term effect of topically applied coenzyme Q10 (CoQ10) on retina and choroid in Alzheimer's disease (AD) was aimed in this study.
METHODS
Randomized controlled study included a total of 93 patients, 62 of whom with AD. Thirty (32.3%) AD patients received treatment (Group 1), 32 (34.4%) AD patients observed without treatment (Group 2), and Group 3 included 31 (33.3%) healthy controls (HC). Neurological and ophthalmological examinations including optical coherence tomography (OCT) were executed.
RESULTS
Retinal nerve fiber layer (RNFL) thickness in all quadrants increased following CoQ10 treatment in Group 1; however significant rise yielded in average and temporal quadrant RNFL thickness. Average and superonasal sector ganglion cell-inner plexiform layer (GCIPL) thickness increased significantly following CoQ10 treatment. The correlation analysis between difference in pre- and posttreatment OCT values in Group 1 revealed that rise in average RNFL thickness was inversely correlated with duration of the disease and rise in average GCIPL thickness and superonasal sector thickness was inversely correlated with severity of the disease.
CONCLUSION
Short-term topical CoQ10 resulted in improvement in AD related retinal ganglion cell (RGC) loss which may reflect the salvage of some RGCs in the reversible transitional phase. More bioavailability through intravitreal route of administration and longer duration of effect with sustained release forms may possibly help enhalting the RGC loss, especially incipience of neurodegenerative diseases.",2020,thickness in all quadrants increased following CoQ10 treatment in Group 1; however significant rise yielded in average and temporal quadrant RNFL thickness.,"[""Alzheimer's disease (AD"", 'Randomized controlled study included a total of 93 patients, 62 of whom with AD']","['optical coherence tomography (OCT', 'Retinal nerve fiber layer (RNFL', 'topical coenzyme Q10', 'topically applied coenzyme Q10 (CoQ10']","['average RNFL thickness', 'average and temporal quadrant RNFL thickness', 'pre- and posttreatment OCT values', 'Average and superonasal sector ganglion cell-inner plexiform layer (GCIPL) thickness', 'average GCIPL thickness and superonasal sector thickness', 'AD related retinal ganglion cell (RGC) loss']","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0228071', 'cui_str': 'Ganglion cell (cell)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0450207', 'cui_str': 'Plexiform (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}]",93.0,0.0362785,thickness in all quadrants increased following CoQ10 treatment in Group 1; however significant rise yielded in average and temporal quadrant RNFL thickness.,"[{'ForeName': 'Refika Hande', 'Initials': 'RH', 'LastName': 'Karakahya', 'Affiliation': 'Department of Ophthalmology, Ordu University School of Medicine, Ordu, Turkey. handekarakahya@gmail.com.'}, {'ForeName': 'Tuba Şaziye', 'Initials': 'TŞ', 'LastName': 'Özcan', 'Affiliation': 'Department of Neurology, Ordu University School of Medicine, Ordu, Turkey.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-019-04544-3']
610,31784704,Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.,"PURPOSE
To compare the efficacy and safety of subthreshold micropulse laser (SML) with threshold conventional laser (TCL) in central serous chorioretinopathy (CSC).
METHODS
Prospective, randomized, double-masked, non-inferiority, 12-week clinical trial. Patients were randomly assigned 1:1 to SML group or TCL group. Patients in the SML group were treated with 577 nm micropulse laser. The spot size was 160 µm, the duty cycle was 5% and exposure time was 0.2 s. The power was 50% threshold tested. Patients in the TCL group were treated with 577 nm continuous laser. The power was 100% threshold tested. The primary outcome was the mean change in best-corrected visual acuity (BCVA) at week 12, with a non-inferiority limit of five letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
RESULTS
Eighty-eight patients were enroled. Seventy-seven patients were male. Forty-four patients were in SML group and 44 in TCL group. At week 12, SML was equivalent to TCL with a gain of 6.23 ± 8.59 and 6.61 ± 6.35 letters, respectively, (SML-TCL difference: -0.38 letters; 95% confidence interval (CI):-3.58-2.81; P non-inferiority = 0.0026). There was no statistically significant difference between the two groups (t = 0.240, P = 0.811). At week 12, the proportion of patients whose SRF had been totally absorbed was 63.63 and 81.82% respectively for SML and TCL groups. There was no statistically significant difference between the two groups (χ 2 = 3.67, P = 0.056).
CONCLUSIONS
Both SML and TCL can improve visual acuity in CSC. SML was non-inferior to TCL in the improvement of BCVA.",2020,"There was no statistically significant difference between the two groups (χ 2 = 3.67, P = 0.056).
","['Forty-four patients were in SML group and 44 in TCL group', 'Eighty-eight patients were enroled', 'central serous chorioretinopathy (CSC', 'Seventy-seven patients were male', 'central serous chorioretinopathy']","['subthreshold micropulse laser compared with threshold conventional laser', 'subthreshold micropulse laser (SML) with threshold conventional laser (TCL', 'TCL', '577\u2009nm continuous laser', '577\u2009nm micropulse laser', 'SML group or TCL', 'SML', 'SML and TCL']","['spot size', 'efficacy and safety', 'mean change in best-corrected visual acuity (BCVA', 'Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts', 'Efficacy and safety', 'visual acuity']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0730328', 'cui_str': 'Central Serous Retinopathy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0183370', 'cui_str': 'Snellen eye chart'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",88.0,0.177868,"There was no statistically significant difference between the two groups (χ 2 = 3.67, P = 0.056).
","[{'ForeName': 'Zuhua', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Chaochao', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Bothwin Clinical Study Consultant, Redmond, WA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Optegra Eye Hospital, London, UK.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China. drliuxiaolin@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0692-8']
611,31784702,Observation of topical tacrolimus on high-risk penetrating keratoplasty patients: a randomized clinical trial study.,"BACKGROUND/OBJECTIVES
To evaluate the clinical efficacy of topical tacrolimus 0.1% and cyclosporine 1% on high-risk penetrating keratoplasty (PKP) patients.
SUBJECTS/METHODS
A series of 49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study. The patients were randomly divided into two groups by receiving either topical tacrolimus 0.1% or cyclosporine 1% respectively. Twenty five patients were treated with topical tacrolimus 0.1% and 24 patients with topical cyclosporine 1%. The traditional baseline management on these two groups were Tobramycin and Dexamethasone eye drops in the first 3 weeks and then tapered off. Clinical procedures and postoperative follow-up were documented.
RESULTS
After 6-54 months follow-up, with the average of 24 months, 11 of 24 high-risk patients (11 eyes) had graft rejection, the rejection rate was 45.8% in topical cyclosporine 1% group. The rejections occurred from 35 days to 20 months after PKP. Three patients had irreversible rejection. On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed. The graft rejection episodes were documented between 23 days and 24 months. As compared with the topical cyclosporine 1%, topical tacrolimus 0.1%, a key immunosuppressant, significantly decreased corneal graft rejection rate (p = 0.02).
CONCLUSIONS
Topical tacrolimus 01% on high-risk PKP patients significantly prevented corneal graft rejection, and it had less adverse effects and was very safe to high-risk patients as to topical cyclosporine 1%. Further case controlled randomized clinical trial studies are needed to establish the best management option for these high-risk patients.",2020,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","['49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study', 'high-risk penetrating keratoplasty (PKP) patients', 'high-risk penetrating keratoplasty patients', 'Twenty five patients were treated with']","['topical cyclosporine', 'Topical tacrolimus', 'topical tacrolimus', 'Tobramycin and Dexamethasone', 'topical tacrolimus 0.1% or cyclosporine', 'cyclosporine']","['rejection rate', 'graft rejection, the rejection rate', 'graft rejection episodes', 'rejections', 'corneal graft rejection', 'rejection', 'irreversible rejection', 'corneal graft rejection rate', 'adverse effects']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022592', 'cui_str': 'Keratoplasty, Penetrating'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0018129', 'cui_str': 'Transplantation Rejection'}, {'cui': 'C0877542', 'cui_str': 'Graft rejection episode'}, {'cui': 'C0339303', 'cui_str': 'Corneal graft rejection (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",2017.0,0.0279068,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","[{'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Zhai', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Zhang', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China. zxr1110@sina.com.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Xu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}]","Eye (London, England)",['10.1038/s41433-019-0717-3']
612,31190607,Brain and lesion segmentation in multiple sclerosis using fully convolutional neural networks: A large-scale study.,"OBJECTIVE
To investigate the performance of deep learning (DL) based on fully convolutional neural network (FCNN) in segmenting brain tissues in a large cohort of multiple sclerosis (MS) patients.
METHODS
We developed a FCNN model to segment brain tissues, including T2-hyperintense MS lesions. The training, validation, and testing of FCNN were based on ~1000 magnetic resonance imaging (MRI) datasets acquired on relapsing-remitting MS patients, as a part of a phase 3 randomized clinical trial. Multimodal MRI data (dual-echo, FLAIR, and T1-weighted images) served as input to the network. Expert validated segmentation was used as the target for training the FCNN. We cross-validated our results using the leave-one-center-out approach.
RESULTS
We observed a high average (95% confidence limits) Dice similarity coefficient for all the segmented tissues: 0.95 (0.92-0.98) for white matter, 0.96 (0.93-0.98) for gray matter, 0.99 (0.98-0.99) for cerebrospinal fluid, and 0.82 (0.63-1.0) for T2 lesions. High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2 > 0.92 for all tissues). The cross validation showed consistent results across the centers for all tissues.
CONCLUSION
The results from this large-scale study suggest that deep FCNN can automatically segment MS brain tissues, including lesions, with high accuracy.",2020,High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2 > 0.92 for all tissues).,['segmenting brain tissues in a large cohort of multiple sclerosis (MS) patients'],"['Multimodal MRI data (dual-echo, FLAIR, and T1-weighted images', 'deep learning (DL) based on fully convolutional neural network (FCNN']",['Dice similarity coefficient'],"[{'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue (substance)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4704761', 'cui_str': 'Deep Learning'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}]",[],,0.039133,High correlations between the DL segmented tissue volumes and ground truth were observed ( R 2 > 0.92 for all tissues).,"[{'ForeName': 'Refaat E', 'Initials': 'RE', 'LastName': 'Gabr', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Coronado', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Department of Electrical Engineering, The University of Texas at Tyler, Houston, TX, USA.'}, {'ForeName': 'Sheeba J', 'Initials': 'SJ', 'LastName': 'Sujit', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Allen', 'Affiliation': 'Texas Advanced Computing Center, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': 'Ponnada A', 'Initials': 'PA', 'LastName': 'Narayana', 'Affiliation': 'Department of Diagnostic and Interventional Imaging, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519856843']
613,31198999,"Birth outcomes in Aboriginal mother-infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006-2011: The PneuMum randomised controlled trial.","BACKGROUND
Pregnant women and infants <6 months old have a high baseline risk for pneumococcal disease compared to the general population, particularly among Indigenous populations living in poverty and low-resource settings. Efficacy trials of pneumococcal vaccination in pregnancy examining adverse birth outcomes are lacking.
AIMS
We report adverse birth events as secondary outcomes from the 'PneuMum' randomised controlled trial of 23-valent pneumococcal polysaccharide vaccination (23vPPV) in pregnancy (August 2006-January 2011).
MATERIALS AND METHODS
Australian Aboriginal women aged 17-39 years with singleton uncomplicated pregnancies were randomised (1:2 ratio) to receive 23vPPV or no 23vPPV in pregnancy at 30-36 weeks gestation. We compared risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA) between vaccinated and unvaccinated pregnant women. Cox proportional hazard ratios (HRs) were calculated on an intention-to-treat basis.
RESULTS
Among 227 enrolled participants, 75 (33%) received 23vPPV in pregnancy. Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94-8.32) P = 0.07; LBW 9% vs 5% (HR 2.09; 95% CI 0.76-5.78) P = 0.15; and SGA 15% vs 17% (HR 1.02; 95% CI 0.50-2.06) P = 0.96. There were no stillbirths.
CONCLUSIONS
We found a numerically higher rate of preterm births among women who received 23vPPV in pregnancy compared to unvaccinated pregnant women. Although further investigation with larger participant numbers is needed to better evaluate this safety signal, the contribution of safety results from smaller studies using appropriate data analysis methodologies is critical, particularly as more clinical trials in pneumococcal vaccination in pregnancy are progressing.",2020,Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94-8.32),"['Aboriginal mother-infant pairs from the Northern Territory, Australia, who received 23-valent polysaccharide pneumococcal vaccination during pregnancy, 2006-2011', 'Australian Aboriginal women aged 17-39\xa0years with singleton uncomplicated pregnancies', '227 enrolled participants, 75 (33%) received', 'Pregnant women and infants <6\xa0months old', 'pregnancy (August 2006-January 2011', 'unvaccinated pregnant women']","['pneumococcal vaccination', '23-valent pneumococcal polysaccharide vaccination (23vPPV', '23vPPV or no 23vPPV', '23vPPV']","['preterm births', 'Cox proportional hazard ratios (HRs', 'adverse birth outcomes', 'risks of stillbirth, preterm birth, low birthweight (LBW), and small for gestational age (SGA']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0028416', 'cui_str': 'Northern Territory'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0419707', 'cui_str': 'Pneumococcal vaccination (procedure)'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}]",227.0,0.446155,Risk differences in adverse birth outcomes between 23vPPV vaccinated and unvaccinated pregnant women were; preterm birth 9% vs 4% (HR 2.79; 95% CI 0.94-8.32),"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McHugh', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Binks', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Nelson', 'Affiliation': 'Top End Health Service, Top End West, Northern Territory, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Dunbar', 'Affiliation': 'Centre of Excellence in Aboriginal and Torres Strait Islander Primary Health Care, Queensland Health, Inala, Queensland, Australia.'}, {'ForeName': 'E Kim', 'Initials': 'EK', 'LastName': 'Mulholland', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, Victoria, Australia.""}, {'ForeName': 'Ross M', 'Initials': 'RM', 'LastName': 'Andrews', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Tiwi, Northern Territory, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13002']
614,31199210,"Suicidal ideation and behavior in adults with major depressive disorder treated with vortioxetine: post hoc pooled analyses of randomized, placebo-controlled, short-term and open-label, long-term extension trials.","OBJECTIVES
This study aimed to evaluate the risk of suicidal ideation and behavior associated with vortioxetine treatment in adults with major depressive disorder (MDD).
METHODS
Suicide-related events were evaluated post hoc using 2 study pools: one short-term pool of 10 randomized, placebo-controlled studies (6-8 weeks) and another long-term pool that included 3 open-label extension studies (52 weeks). Evaluation of suicide-related events was performed using Columbia-Suicide Severity Rating Scale (C-SSRS) scores and treatment-emergent adverse events (TEAEs) data.
RESULTS
At baseline, the percentage of patients reporting any C-SSRS ideation or behavior events in short-term studies was similar between placebo (14.7%), vortioxetine (19.8%, 13.0%, 11.2%, and 13.7% for 5-, 10-, 15-, and 20-mg groups, respectively), and duloxetine active reference (13.2%) and did not change throughout the 6- to 8-week treatment period for placebo (17.0%), vortioxetine (19.3%, 13.5%, 12.6%, and 15% for 5-, 10-, 15-, and 20-mg groups, respectively), or duloxetine (11.3%). The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine. After 52-week treatment with vortioxetine, suicidal ideation based on C-SSRS was 9.8%, C-SSRS suicidal behavior was 0.2%, and the incidence of suicide-related events based on TEAEs was <1%. There were no completed suicides in any study.
CONCLUSIONS
Vortioxetine is not associated with increased risk of suicidal ideation or behavior in MDD patients.",2020,"The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine.","['adults with major depressive disorder treated with', 'Suicide-related events were evaluated post hoc using 2 study pools: one short-term pool of 10 randomized', 'MDD patients', 'adults with major depressive disorder (MDD']","['Vortioxetine', 'placebo', 'placebo-controlled studies (6-8 weeks) and another long-term pool that included 3 open-label extension studies', 'vortioxetine', 'duloxetine']","['Suicidal ideation and behavior', 'suicidal ideation based on C-SSRS', 'percentage of patients reporting any C-SSRS ideation or behavior events', 'Columbia-Suicide Severity Rating Scale (C-SSRS) scores and treatment-emergent adverse events (TEAEs) data', 'incidence of suicide-related events for TEAEs', 'C-SSRS suicidal behavior', 'risk of suicidal ideation or behavior']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3888485', 'cui_str': 'Columbia suicide severity rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.134701,"The incidence of suicide-related events for TEAEs in the short-term pool was 0.4% for placebo, 0.2% or 1.0% for vortioxetine 5 mg or 10 mg, and 0.7% each for vortioxetine 15 mg and 20 mg, as well as duloxetine.","[{'ForeName': 'Atul R', 'Initials': 'AR', 'LastName': 'Mahableshwarkar', 'Affiliation': 'Clinical Development, BlackThorn Therapeutics, San Francisco, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Affinito', 'Affiliation': 'Global Patient Safety Evaluation Marketed Products Group, Takeda Development Center Americas, Inc., One Takeda Parkway, Deerfield, Illinois, USA.'}, {'ForeName': 'Elin Heldbo', 'Initials': 'EH', 'LastName': 'Reines', 'Affiliation': 'Medical Affairs, H. Lundbeck A/S, Ottiliavej 9, 2500Valby, Denmark.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Biostatistics, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nomikos', 'Affiliation': 'Clinical Research & Development, Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Paula L', 'Initials': 'PL', 'LastName': 'Jacobsen', 'Affiliation': 'Neuroscience, Takeda Development Center Americas, Inc., Deerfield, Illinois, USA.'}]",CNS spectrums,['10.1017/S109285291900097X']
615,31669447,Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment.,"BACKGROUND
The VITamin D and OmegA-3 TriaL (VITAL) is a completed randomized, placebo-controlled trial of vitamin D 3 (2000 IU/day) and marine omega-3 (1 g/day) supplements in the primary prevention of cancer and cardiovascular disease. Here we examine baseline and change in 25-hydroxyvitamin D (25(OH)D) and related biomarkers with randomized treatment and by clinical factors.
METHODS
Baseline 25(OH)D was measured in 15,804 participants (mean age 68 years.; 50.8% women; 15.7% African Americans) and in 1660 1-year follow-up samples using liquid chromatography-tandem mass spectrometry and chemiluminescence. Calcium and parathyroid hormone (iPTH) were measured by chemiluminescence and spectrophotometry respectively.
RESULTS
Mean baseline total 25(OH)D (ng/mL ± SD) was 30.8 ± 10.0 ng/mL, and correlated inversely with iPTH (r = -0.28), p < .001. After adjusting for clinical factors, 25(OH)D (ng/mL ± SE) was lower in men vs women (29.7 ± 0.30 vs 31.4 ± 0.30, p < .0001) and in African Americans vs whites (27.9 ± 0.29 vs 32.5 ± 0.22, p < .0001). It was also lower with increasing BMI, smoking, and latitude, and varied by season. Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo. The largest increases were noted among individuals with low baseline and African Americans. Results were similar for chemiluminescent immunoassay. Mean calcium was unchanged, and iPTH decreased with treatment.
CONCLUSION
In VITAL, baseline 25(OH)D varied by clinical subgroups, was lower in men and African Americans. Concentrations increased with vitamin D supplementation, with the greatest increases in those with lower baseline 25(OH)D. The seasonal trends in 25(OH)D, iPTH, and calcium may be relevant when interpreting 25(OH)D levels for clinical treatment decisions.
CLINICAL TRIAL REGISTRATION
VITAL ClinicalTrials.gov number NCT01169259.",2019,Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo.,"['15,804 participants (mean age 68\u202fyears', 'number', 'individuals with low baseline and African Americans']","['vitamin D supplementation', 'placebo', 'marine omega-3', 'VITamin D and OmegA-3 TriaL', 'vitamin D']","['total 25(OH)D (ng/mL\u202f±\u202fSD', 'BMI, smoking, and latitude, and varied by season', 'Mean 1-year 25(OH)D', 'Calcium and parathyroid hormone (iPTH', '25-hydroxyvitamin D (25(OH)D', 'Serum 25-hydroxyvitamin D', 'Mean calcium']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.470621,Mean 1-year 25(OH)D increased by 11.9 ng/mL in the active group and decreased by 0.7 ng/mL in placebo.,"[{'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Luttmann-Gibson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Landmark Center West, 401 Park Drive, Boston, MA 02215, USA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Division of Cardiovascular Medicine and Center for Lipid Metabolomics, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: smora@bwh.harvard.edu.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02114, USA; Channing Division of Network Medicine, Department of Medicine, Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Ghoshal', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Wohlgemuth', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Kulkarni', 'Affiliation': 'Atherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA; VAP Diagnostics R&D Laboratory, 201 London Pkwy, Birmingham, AL 3521, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Larsen', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prentice', 'Affiliation': 'Quest Diagnostics, 27027 Tourney Road, Valencia, CA 91355, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cobble', 'Affiliation': 'Atherotech Diagnostics, 201 London Pkwy #400, Birmingham, AL 35211, USA.'}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Chunying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, 900 Commonwealth Avenue, Boston, MA 02215, USA; Department of Epidemiology, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA 02115, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2019.105854']
616,31198103,Association of brain volume loss and long-term disability outcomes in patients with multiple sclerosis treated with teriflunomide.,"BACKGROUND
Teriflunomide 14 mg significantly reduced brain volume loss (BVL) and confirmed disability worsening (CDW) compared with placebo in the TEMSO core study.
OBJECTIVE
To investigate the relationship between BVL from Baseline to Year 2 in the TEMSO core study and long-term CDW (Year 7) in the TEMSO long-term extension (NCT00803049).
METHODS
Structural Image Evaluation using Normalization of Atrophy determined BVL. Long-term CDW was assessed by Expanded Disability Status Scale confirmed for 12 and 24 weeks. An additional analysis evaluated the relative contribution of BVL (Year 2) and other outcomes as potential mediators of the effect of teriflunomide 14 mg on 12-week CDW.
RESULTS
Patients with the least BVL were significantly less likely to have 12- and 24-week CDW at Year 7 compared with patients with the most BVL. A mediation analysis revealed that BVL (Year 2) explained 51.3% of the treatment effect on CDW; new or enlarging T 2w lesions over 2 years explained 30.8%, and relapses in the first 2 years explained 38.5%.
CONCLUSIONS
These results highlight the potential predictive value of BVL earlier in the disease course on long-term disability outcomes. The mediation analysis suggests that teriflunomide may prevent disability worsening largely through its effects on BVL.",2020,"A mediation analysis revealed that BVL (Year 2) explained 51.3% of the treatment effect on CDW; new or enlarging T 2w lesions over 2 years explained 30.8%, and relapses in the first 2 years explained 38.5%.
",['patients with multiple sclerosis treated with teriflunomide'],['placebo'],"['Expanded Disability Status Scale', 'brain volume loss (BVL) and confirmed disability worsening (CDW']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}]",,0.0435541,"A mediation analysis revealed that BVL (Year 2) explained 51.3% of the treatment effect on CDW; new or enlarging T 2w lesions over 2 years explained 30.8%, and relapses in the first 2 years explained 38.5%.
","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'University Hospital Basel, Basel, Switzerland/ Department of Neurology, DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ernst-Wilhelm', 'Initials': 'EW', 'LastName': 'Radue', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gaetano', 'Affiliation': 'Medical Image Analysis Center, Basel, Switzerland/ Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research and Biomedical Engineering, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mueller-Lenke', 'Affiliation': 'Medical Image Analysis Center, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wuerfel', 'Affiliation': 'Medical Image Analysis Center, Basel, Switzerland/ Department of Biomedical Engineering, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Poole', 'Affiliation': 'Global Scientific Communications, Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Cavalier', 'Affiliation': 'Global Scientific Communications, Sanofi, Cambridge, MA, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519855722']
617,31784747,Biomarkers and Noncalcified Coronary Artery Plaque Progression in Older Men Treated With Testosterone.,"OBJECTIVE
Recent results from the Cardiovascular Trial of the Testosterone Trials showed that testosterone treatment of older men with low testosterone was associated with greater progression of noncalcified plaque (NCP). We evaluated the effect of anthropometric measures and cardiovascular biomarkers on plaque progression in individuals in the Testosterone Trial.
METHODS
The Cardiovascular part of the trial included 170 men aged 65 years or older with low testosterone. Participants received testosterone gel or placebo gel for 12 months. The primary outcome was change in NCP volume from baseline to 12 months, as determined by coronary computed tomography angiography (CCTA). We assayed several markers of cardiovascular risk and analyzed each marker individually in a model as predictive variables and change in NCP as the dependent variable.
RESULTS
Of 170 enrollees, 138 (73 testosterone, 65 placebo) completed the study and were available for the primary analysis. Of 10 markers evaluated, none showed a significant association with the change in NCP volume, but a significant interaction between treatment assignment and waist-hip ratio (WHR) (P = 0.0014) indicated that this variable impacted the testosterone effect on NCP volume. The statistical model indicated that for every 0.1 change in the WHR, the testosterone-induced 12-month change in NCP volume increased by 26.96 mm3 (95% confidence interval, 7.72-46.20).
CONCLUSION
Among older men with low testosterone treated for 1 year, greater WHR was associated with greater NCP progression, as measured by CCTA. Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.",2020,Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.,"['individuals in the T Trial', '170 men aged 65 years or older with low T. Participants received', 'older men', 'Older Men Treated with', '170 enrollees', 'older men with low T']","['Testosterone(T', 'T gel or placebo gel', 'Testosterone']","['change in NCP volume', 'waist-hip ratio', 'NCP volume', 'coronary computed tomography angiography (CCTA', 'testosterone effect on non-calcified plaque volume', 'non-calcified plaque volume', 'plaque progression', 'progression of non-calcified plaque (NCP']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",170.0,0.301467,Other biomarkers and anthropometric measures did not show statistically significant association with plaque progression.,"[{'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Rine', 'Initials': 'R', 'LastName': 'Nakanishi', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Snyder', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Juhwan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Nanette K', 'Initials': 'NK', 'LastName': 'Wenger', 'Affiliation': 'Department of Medicine, Division of Cardiology, Emory Heart and Vascular Center Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'Division of Preventive Medicine, University of Alabama at Birmingham, Alabama.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Swerdloff', 'Affiliation': 'Division of Endocrinology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Preston', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Hamal', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Sheilds', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': 'Department of Family and Preventive Medicine, Division of Epidemiology, University of California, San Diego School of Medicine, La Jolla, California.'}, {'ForeName': 'Lavanya', 'Initials': 'L', 'LastName': 'Cherukuri', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Cauley', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Graduate School of Public Health, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'Divisions of Endocrinology and Geriatrics, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Glenn R', 'Initials': 'GR', 'LastName': 'Cunningham', 'Affiliation': ""Departments of Medicine and Molecular & Cellular Biology, Division of Diabetes, Endocrinology and Metabolism, Baylor College of Medicine and Baylor St. Luke's Medical Center, Houston, Texas.""}, {'ForeName': 'Kristine E', 'Initials': 'KE', 'LastName': 'Ensrud', 'Affiliation': 'Department of Medicine, Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Alvin M', 'Initials': 'AM', 'LastName': 'Matsumoto', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Department of Veterans Affairs, Puget Sound Health System, and Division of Gerontology and Geriatric Medicine, Department of Internal Medicine, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molich', 'Affiliation': 'Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Venkata M', 'Initials': 'VM', 'LastName': 'Alla', 'Affiliation': 'Division of Cardiovascular Diseases, Creighton University School of Medicine, Omaha, Nebraska.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Birudaraju', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Nezarat', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Kelash', 'Initials': 'K', 'LastName': 'Rai', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Shone', 'Initials': 'S', 'LastName': 'Almeida', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Sion K', 'Initials': 'SK', 'LastName': 'Roy', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sheikh', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Trad', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Division of Cardiology, Lundquist Institute of Biomedical Innovation, Harbor-University of California at Los Angeles Medical Center, Torrance, California.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz242']
618,31750110,Harmonic Scalpel Versus Coblation Tonsillectomy A Comparative Study.,"Tonsillectomy is an age old procedure in ENT practice. Though traditional dissection method is gold standard, we surgeons are trying different techniques like electrocautery, coblation, harmonic scalpel (HS) mainly to improve surgical convenience, to decrease operative time, post operative pain, intra and post operative bleeding and fast return to normal life. In this particular study we are comparing coblation and HS as surgical tool in tonsillectomy. It is a prospective double-blind randomized controlled trial where information was compared between two groups of coblation and HS tonsillectomy. A total number of 128 patients were compared over operation time, intra-operative blood loss, postoperative pain, time needed to regain the normal diet and activity and postoperative haemorrhage. We found statistically significant differences in operation time ( p < 0.001) and intra operative blood loss ( p < 0.001). Secondary haemorrhage rate was far better in HS (1.5%) group compared to coblation (7.8%). Whereas postoperative pain, time needed to go back to the normal diet and activity were better in HS group but the difference is not significant. This study revealed a significantly less operative time and intra-operative and post operative blood loss in harmonic scalpel tonsillectomy in comparison with coblation method. These findings addressed HS tonsillectomy as an advanced method.",2019,This study revealed a significantly less operative time and intra-operative and post operative blood loss in harmonic scalpel tonsillectomy in comparison with coblation method.,['A total number of 128 patients'],"['harmonic scalpel tonsillectomy', 'Tonsillectomy', 'Harmonic Scalpel Versus Coblation Tonsillectomy']","['postoperative pain, time needed to go back to the normal diet and activity', 'operative time and intra-operative and post operative blood loss', 'Secondary haemorrhage rate', 'intra operative blood loss', 'operation time', 'operation time, intra-operative blood loss, postoperative pain, time needed to regain the normal diet and activity and postoperative haemorrhage']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C1960390', 'cui_str': 'Coblation tonsillectomy'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0347697', 'cui_str': 'Secondary hemorrhage (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}]",128.0,0.0490205,This study revealed a significantly less operative time and intra-operative and post operative blood loss in harmonic scalpel tonsillectomy in comparison with coblation method.,"[{'ForeName': 'Soumik', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Ent Head Neck Surgery, Institute of Postgraduate Medical Education Research, 244 AJC Bose Road, Kolkata, 700020 India.'}, {'ForeName': 'Anindita', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Department of Ent Head Neck Surgery, Institute of Postgraduate Medical Education Research, 244 AJC Bose Road, Kolkata, 700020 India.'}, {'ForeName': 'Arya Brata', 'Initials': 'AB', 'LastName': 'Dubey', 'Affiliation': 'Department of Ent Head Neck Surgery, Institute of Postgraduate Medical Education Research, 244 AJC Bose Road, Kolkata, 700020 India.'}, {'ForeName': 'Arunabha', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Department of Ent Head Neck Surgery, Institute of Postgraduate Medical Education Research, 244 AJC Bose Road, Kolkata, 700020 India.'}]",Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India,['10.1007/s12070-019-01679-x']
619,31769377,"Efficacy of trial-based cognitive therapy, behavioral activation and treatment as usual in the treatment of major depressive disorder: preliminary findings from a randomized clinical trial.","INTRODUCTION
Major depressive disorder (MDD) is a prevalent, debilitating and disabling disorder, and its prevalence is increasing. Antidepressants (AD), cognitive-behavioral therapy (CBT) and behavioral activation (BA) are the main treatments for MDD. Trial-based cognitive therapy (TBCT) addresses and restructures dysfunctional negative core beliefs (CBs) and is a novel and promising approach.
OBJECTIVE
The aim of this study was to compare the efficacy of TBCT, BA and treatment as usual (TAU) in the treatment of MDD.
METHODS
A total of 76 patients with MDD were randomized into 1 of 3 groups and evaluated at baseline, after 6 weeks and at week 12 (final evaluation). The primary outcome was changing in HAM-D scores, and the secondary outcomes included scores on the BDI, CD-Quest, Sheehan Disability Scale (SDS) and WHOQOL.
RESULTS
Both TBCT and BA (which also included AD) were different from TAU (which included antidepressants alone) in reducing the HAM-D and BDI scores and other measures. TBCT and BA were different from TAU in the reduction of disability in SDS and WHOQOL physical domain scores. Besides limited by a small sample size, the dropout rate in the TAU arm was higher, and only 10 patients completed the 3 evaluations.
CONCLUSION
This trial provides evidence that TBCT and BA combined with antidepressants were more efficacious than the TAU (drug alone) in reducing the severity of depressive symptoms and disability, showing that this combination can be useful for clinical practice.",2020,TBCT and BA were different from TAU in the reduction of disability in SDS and WHOQOL physical domain scores.,"['Major depressive disorder (MDD', '76 patients with MDD', 'major depressive disorder']","['Antidepressants (AD), cognitive-behavioral therapy (CBT) and behavioral activation (BA', 'cognitive therapy (TBCT', 'TBCT', 'trial-based cognitive therapy, behavioral activation', 'TBCT, BA']","['scores on the BDI, CD-Quest, Sheehan Disability Scale (SDS) and WHOQOL', 'disability in SDS and WHOQOL physical domain scores', 'HAM-D and BDI scores', 'TBCT and BA', 'changing in HAM-D scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",76.0,0.0804249,TBCT and BA were different from TAU in the reduction of disability in SDS and WHOQOL physical domain scores.,"[{'ForeName': 'Curt', 'Initials': 'C', 'LastName': 'Hemanny', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Carvalho', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Maia', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Reis', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Botelho', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Dagoberto', 'Initials': 'D', 'LastName': 'Bonavides', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Seixas', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Irismar Reis', 'Initials': 'IR', 'LastName': 'de Oliveira', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}]",CNS spectrums,['10.1017/S1092852919001457']
620,31609772,Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial.,"OBJECTIVES
To assess the impact of early triggered palliative care consultation on the outcomes of high-risk ICU patients.
DESIGN
Single-center cluster randomized crossover trial.
SETTING
Two medical ICUs at Barnes Jewish Hospital.
PATIENTS
Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality.
INTERVENTIONS
The medical ICUs were randomized to intervention or usual care followed by washout and crossover, with independent assignment of patients to each ICU at admission. Intervention arm patients received a palliative care consultation from an interprofessional team led by board-certified palliative care providers within 48 hours of ICU admission.
MEASUREMENTS AND MAIN RESULTS
Ninety-seven patients (48.7%) were assigned to the intervention and 102 (51.3%) to usual care. Transition to do-not-resuscitate/do-not-intubate occurred earlier and significantly more often in the intervention group than the control group (50.5% vs 23.4%; p < 0.0001). The intervention group had significantly more transfers to hospice care (18.6% vs 4.9%; p < 0.01) with fewer ventilator days (median 4 vs 6 d; p < 0.05), tracheostomies performed (1% vs 7.8%; p < 0.05), and postdischarge emergency department visits and/or readmissions (17.3% vs 38.9%; p < 0.01). Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group. There was no significant difference in ICU length of stay (median 5 vs 5.5 d), hospital length of stay (median 10 vs 11 d), in-hospital mortality (22.6% vs 29.4%), or 30-day mortality between groups (35.1% vs 36.3%) (p > 0.05).
CONCLUSIONS
Early triggered palliative care consultation was associated with greater transition to do-not-resuscitate/do-not-intubate and to hospice care, as well as decreased ICU and post-ICU healthcare resource utilization. Our study suggests that routine palliative care consultation may positively impact the care of high risk, critically ill patients.",2019,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","['high-risk ICU patients', 'Two medical ICUs at Barnes Jewish Hospital', 'Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality']",['palliative care consultation from an interprofessional team led by board-certified palliative care providers'],"['ICU length of stay', 'postdischarge emergency department visits and/or readmissions', 'total operating cost', 'hospital mortality', 'transfers to hospice care', 'hospital length of stay', '30-day mortality', 'medical ICU', 'operating costs']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",97.0,0.0982293,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Duke Palliative Care, Department of Medicine, Duke University and Health System, Durham, NC.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buettner', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pollard', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Muir', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Kolekar', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Al-Hammadi', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kollef', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dans', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}]",Critical care medicine,['10.1097/CCM.0000000000004016']
621,30024233,"Effects of a methodological infographic on research participants' knowledge, transparency, and trust.","OBJECTIVE
Given participants' research literacy is essential for clinical trial participation, evidence-based strategies are needed that improve literacy and easily accessed online. We tested whether an infographic letter-that illustrated how dropouts can distort study conclusions-improved participant knowledge about the impact of dropouts relative to a control letter.
METHOD
In three distinct online samples purposely recruited to assess reproducibility, young ethnically diverse adults were randomized to read an infographic letter or control letter in a hypothetical scenario. Secondary outcomes included participants' perceived transparency of the research organization, perceived value of retention, and perceived trust of the organization. We purposely included two discriminant items, perceived value for the trial outcome and keeping commitments in general, both hypothesized not to change.
RESULTS
Across samples, ∼20% more infographic participants correctly answered how dropouts affected study conclusions than control participants. For example (Experiment 3), nearly 90% of infographic participants correctly answered versus only two thirds of controls (88.7% vs. 66.7%, absolute percentage difference 22.0%, p < .0001). Infographic participants had substantially higher transparency, perceived value for retention, and trust (Cohen's ds = 0.4-1.0, ps < .0001), yet importantly did not value the study outcome or report keeping commitments more than control participants (Cohen's ds = 0.0-0.1, ps > .10).
CONCLUSIONS
Promisingly, this transparent, visually powerful methodological infographic improved knowledge and trust. Future trials could embed and experimentally test whether such low-cost online infographics improve not only research literacy, but also trial retention, especially among populations with less initial trust about research. (PsycINFO Database Record",2018,"Infographic participants had substantially higher transparency, perceived value for retention, and trust (Cohen's ds = 0.4-1.0, ps < .0001), yet importantly did not value the study outcome or report keeping commitments more than control participants (Cohen's ds = 0.0-0.1, ps > .10).
",['young ethnically diverse adults'],"['methodological infographic', 'infographic letter or control letter']","['higher transparency, perceived value for retention, and trust', ""participants' perceived transparency of the research organization, perceived value of retention, and perceived trust of the organization""]","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0035168'}, {'cui': 'C0220885', 'cui_str': 'organization'}]",,0.170579,"Infographic participants had substantially higher transparency, perceived value for retention, and trust (Cohen's ds = 0.4-1.0, ps < .0001), yet importantly did not value the study outcome or report keeping commitments more than control participants (Cohen's ds = 0.0-0.1, ps > .10).
","[{'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kiernan', 'Affiliation': 'Stanford Prevention Research Center.'}, {'ForeName': 'Marily A', 'Initials': 'MA', 'LastName': 'Oppezzo', 'Affiliation': 'Stanford Prevention Research Center.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'Department of Health Behavior & Health Education, School of Public Health, University of Michigan.'}, {'ForeName': 'Gwen L', 'Initials': 'GL', 'LastName': 'Alexander', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Health System.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000631']
622,31115611,Preoperative predictors and a prediction score for perception of improvement after mesh prolapse surgery.,"INTRODUCTION AND HYPOTHESIS
Pelvic organ prolapse (POP) surgery using a mesh has a complication rate of 26%, and an estimated 10% of those operated on do not consider it brings improvement. The objective of this study was to identify preoperative predictors of improvement after POP repair with mesh to develop a predictive score.
METHODS
This is a secondary analysis of the randomized multicenter trial PROSPERE, which compared morbidity after prolapse repair with mesh according to the vaginal or laparoscopic approach. Improved women [PGI-I score at 1-year follow-up = 1 (much better) or 2 (better)] were compared with unimproved women. Two hundred fifty-five women were included to derive the prediction score based on multiple logistic regression. An internal validation by bootstrapping estimated the unbiased performance of the model.
RESULTS
Criteria independently related to improvement were: (1) cystocele stage > II [OR: 2.93 95% CI (1.22-7.04), p = 0.015]; (2) preoperative expectation related to bulge symptom improvement [OR: 2.57 95% CI (1.07-6.04), p = 0.031] and (3) absence of chronic pelvic pain [OR: 4.55 95% CI (1.77-11.46), p = 0.001]. A score (scored from 0 to 11) was constructed from the aOR of the predictive model: the ROC-AUC of the score was 0.75, and a score ≥ 9 predicted a 97% chance of improvement (95% CI 92-99), with a specificity of 85% (95% CI 68-94). The ROC-AUC corrected for optimism by the bootstrap procedure was 0.70.
CONCLUSIONS
This score could be used by surgeons in preoperative counseling of women.",2020,"RESULTS
Criteria independently related to improvement were: (1) cystocele stage > II [OR: 2.93 95% CI (1.22-7.04), p = 0.015]; (2) preoperative expectation related to bulge symptom improvement [OR: 2.57 95% CI (1.07-6.04), p = 0.031] and (3) absence of chronic pelvic pain [OR: 4.55 95% CI (1.77-11.46), p = 0.001].",['Two hundred fifty-five women'],[],['chronic pelvic pain'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]",255.0,0.208497,"RESULTS
Criteria independently related to improvement were: (1) cystocele stage > II [OR: 2.93 95% CI (1.22-7.04), p = 0.015]; (2) preoperative expectation related to bulge symptom improvement [OR: 2.57 95% CI (1.07-6.04), p = 0.031] and (3) absence of chronic pelvic pain [OR: 4.55 95% CI (1.77-11.46), p = 0.001].","[{'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Chattot', 'Affiliation': 'EA 7285 Research Unit ""Risk and Safety in Clinical Medicine for Women and Perinatal Health"", Versailles-Saint-Quentin University (UVSQ), 78180, Montigny-le-Bretonneux, France. cchattot@gmail.com.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Deffieux', 'Affiliation': 'EA 7285 Research Unit ""Risk and Safety in Clinical Medicine for Women and Perinatal Health"", Versailles-Saint-Quentin University (UVSQ), 78180, Montigny-le-Bretonneux, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lucot', 'Affiliation': 'Gynecological Surgery Unit, Centre Hospitalier Universitaire Jeanne de Flandre, 59 000, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Fritel', 'Affiliation': 'Department of Obstetrics and Gynecology and Reproductive Medicine, Centre Hospitalier Universitaire de Poitiers, 86021, Poitier, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Fauconnier', 'Affiliation': 'EA 7285 Research Unit ""Risk and Safety in Clinical Medicine for Women and Perinatal Health"", Versailles-Saint-Quentin University (UVSQ), 78180, Montigny-le-Bretonneux, France.'}]",International urogynecology journal,['10.1007/s00192-019-03953-6']
623,32492104,Exercise Electrocardiography and Computed Tomography Coronary Angiography for Patients With Suspected Stable Angina Pectoris: A Post Hoc Analysis of the Randomized SCOT-HEART Trial.,"Importance
Recent European guidance supports a diminished role for exercise electrocardiography (ECG) in the assessment of suspected stable angina.
Objective
To evaluate the utility of exercise ECG in contemporary practice and assess the value of combined functional and anatomical testing.
Design, Setting, and Participants
This is a post hoc analysis of the Scottish Computed Tomography of the Heart (SCOT-HEART) open-label randomized clinical trial, conducted in 12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease. Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent exercise ECG prior to randomization. Statistical analysis was conducted from October 10 to November 5, 2019.
Interventions
Patients were randomized in a 1:1 ratio to receive standard care plus coronary computed tomography (CT) angiography or to receive standard care alone. The present analysis was limited to the 3283 patients who underwent exercise ECG alone or in combination with coronary CT angiography.
Main Outcomes and Measures
The primary clinical end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years.
Results
Among the 3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography. Abnormal results of exercise ECG were associated with a 14.47-fold (95% CI, 10.00-20.41; P < .001) increase in coronary revascularization at 1 year and a 2.57-fold (95% CI, 1.38-4.63; P < .001) increase in mortality from coronary heart disease death at 5 years or in cases of nonfatal myocardial infarction at 5 years. Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002). The greatest numerical difference in outcome with CT angiography compared with exercise ECG alone was observed for those with inconclusive results of exercise ECG (6 of 283 [2%] vs 18 of 283 [6%]), although this was not statistically significant (log-rank P = .05).
Conclusions and Relevance
This study suggests that abnormal results of exercise ECG are associated with coronary revascularization and the future risk of adverse coronary events. However, coronary CT angiography more accurately detects coronary artery disease and is more strongly associated with future risk compared with exercise ECG.
Trial Registration
ClinicalTrials.gov Identifier: NCT01149590.",2020,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","['With Suspected Stable Angina Pectoris', 'Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent', 'Patients', '12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease', '3283 patients who underwent', '3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography']","['coronary CT angiography', 'exercise ECG', 'Exercise Electrocardiography and Computed Tomography Coronary Angiography', 'exercise electrocardiography (ECG', 'exercise ECG alone or in combination with coronary CT angiography', 'CT angiography', 'standard care plus coronary computed tomography (CT) angiography or to receive standard care alone']","['mortality from coronary heart disease death', 'coronary revascularization', 'exercise ECG', 'death from coronary heart disease or nonfatal myocardial infarction at 5 years', '5-year coronary heart disease death or nonfatal myocardial infarction']","[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",4146.0,0.139474,"Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002).","[{'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Singh', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Bing', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Dweck', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Edwin J R', 'Initials': 'EJR', 'LastName': 'van Beek', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'Williams', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Division of Cardiovascular Medicine, University of Virginia, Charlottesville.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom.'}]",JAMA cardiology,['10.1001/jamacardio.2020.1567']
624,31669450,Rationale and design of a randomized pragmatic trial of patient-centered models of hepatitis C treatment for people who inject drugs: The HERO study.,"BACKGROUND
Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk. As direct-acting antiviral agents (DAAs) have achieved sustained virologic response (SVR) rates of 95% or more, evidence-based strategies are urgently needed to demonstrate real-world effectiveness in marginalized patient populations such as PWID. The objectives of this study are: 1) to determine whether either of two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) - results in more forward movement along the HCV care cascade including treatment initiation, adherence, and SVR; 2) using quantitative and qualitative methods, to understand factors associated with lack of treatment uptake, poor adherence (<80%), failure to achieve SVR, DAA resistance, and HCV reinfection.
METHODS
The HERO study is a multi-site, pragmatic randomized clinical trial conducted in eight states where 754 HCV-infected PWID were randomly assigned to either PN or mDOT.
CONCLUSIONS
This study addresses an urgent need for timely and accurate information on optimal models of care to promote HCV treatment initiation, adherence, treatment completion and SVR among PWID, as well as rates and factors associated with reinfection and resistance after treatment. This clinical trial has the potential to provide valuable information on how to reduce the burden of the HCV epidemic in PWID.",2019,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","['eight states where 754 HCV-infected PWID', 'people who inject drugs']","['direct-acting antiviral agents (DAAs', 'hepatitis C treatment', 'two patient-centered treatment models - patient navigation (PN) or modified directly observed therapy (mDOT) ', 'PN or mDOT']","['failure to achieve SVR, DAA resistance, and HCV reinfection', 'virologic response (SVR) rates']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0003451', 'cui_str': 'Antiviral Drugs'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205339', 'cui_str': 'Reinfection (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}]",,0.0854155,"Although people who inject drugs (PWID) having the highest incidence and prevalence of hepatitis C virus (HCV) in the US, HCV treatment is rarely provided to PWID due to assumptions about poor adherence and reinfection risk.","[{'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, University of South Carolina School of Medicine, Greenville, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA. Electronic address: Alain.Litwin@prismahealth.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jost', 'Affiliation': 'Department of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University Clemson, SC, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Karasz', 'Affiliation': 'Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Feinberg', 'Affiliation': 'Department of Behavioral Medicine & Psychiatry and Department of Medicine, West Virginia University, Morgantown, WV, USA.'}, {'ForeName': 'Arthur Y', 'Initials': 'AY', 'LastName': 'Kim', 'Affiliation': 'Department of Infectious Diseases, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Lum', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Taylor', 'Affiliation': 'College of Pharmacy, University of Rhode Island, CODAC Behavioral Health, Providence, RI, USA.'}, {'ForeName': 'Judith I', 'Initials': 'JI', 'LastName': 'Tsui', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Clemson University School of Health Research, Clemson, SC, USA; Department of Medicine, Prisma Health, Greenville, SC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Page', 'Affiliation': 'Department of Internal Medicine, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2019.105859']
625,30915538,Lower body negative pressure enhances oxygen availability in the knee extensor muscles during intense resistive exercise in supine position.,"PURPOSE
During exercise in supine posture or under microgravity in space, the gravity-dependent component of local blood pressure in leg muscles at upright posture can be simulated by lower body negative pressure (LBNP). We hypothesized that during resistive exercise LBNP favors oxygen availability in lower extremities, benefiting energy levels and performance of working muscles.
METHODS
In permutated crossover design, nine subjects performed a series of fifteen slow-paced concentric (4 s) and eccentric contractions (4 s) without or with 40 mmHg LBNP and 4 s pause between repetitions. The force at knee flexion was 6% of the one repetition maximum (1-RM) and gradually increased to 60% 1RM in the first half of the individual range of motion, subsequently remaining constant until full extension.
RESULTS
During the low force periods of continuous exercise, LBNP enhanced the refill of capillary blood measured by near infrared spectroscopy, amplifying the increase of total haemoglobin by about 20 µmol/l (p < 0.01) and oxyhaemoglobin by about 10 µmol/l (p < 0.01). During continuous exercise, LBNP induced a trend towards a lower EMG increment. This LBNP effect was not found when the periods of low forces at knee flexion were extended by 4 s pauses. Increased respiratory oxygen uptake (+ 0.1 l/min, p < 0.05) indicated overall enhanced muscle energy turn-over.
CONCLUSIONS
Our results suggest stimulation of oxidative metabolism through LBNP enables working muscles to meet the energy demands of intense exercise. Further research is needed on the consequences for energy metabolism and the molecular control of growth and differentiation.",2019,"Increased respiratory oxygen uptake (+ 0.1 l/min, p < 0.05) indicated overall enhanced muscle energy turn-over.
",[],"['slow-paced concentric (4\xa0s) and eccentric contractions (4\xa0s) without or with 40\xa0mmHg LBNP and 4\xa0s pause between repetitions', 'resistive exercise LBNP']","['refill of capillary blood', 'Increased respiratory oxygen uptake', 'total haemoglobin', 'oxyhaemoglobin']",[],"[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0024047', 'cui_str': 'LBNP'}, {'cui': 'C0203991', 'cui_str': 'Resistive exercise (regime/therapy)'}]","[{'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1168591', 'cui_str': 'Oxyhaemoglobin'}]",9.0,0.0392356,"Increased respiratory oxygen uptake (+ 0.1 l/min, p < 0.05) indicated overall enhanced muscle energy turn-over.
","[{'ForeName': 'Dajana', 'Initials': 'D', 'LastName': 'Parganlija', 'Affiliation': 'Space Physiology Department, Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany. Dajana.Parganlija@dlr.de.'}, {'ForeName': 'Vita', 'Initials': 'V', 'LastName': 'Nieberg', 'Affiliation': 'Space Physiology Department, Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sauer', 'Affiliation': 'Space Physiology Department, Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Rittweger', 'Affiliation': 'Space Physiology Department, Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Institute of Cardiovascular Research and Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Zange', 'Affiliation': 'Space Physiology Department, Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}]",European journal of applied physiology,['10.1007/s00421-019-04113-w']
626,31530667,"Efficacy, Safety, and Tolerability of Oral Semaglutide Versus Placebo Added to Insulin With or Without Metformin in Patients With Type 2 Diabetes: The PIONEER 8 Trial.","OBJECTIVE
To investigate the efficacy, safety, and tolerability of oral semaglutide added to insulin with or without metformin.
RESEARCH DESIGN AND METHODS
Patients with type 2 diabetes uncontrolled on insulin with or without metformin were randomized to oral semaglutide 3 mg ( N = 184), 7 mg ( N = 182), or 14 mg ( N = 181) or to placebo ( N = 184) in a 52-week, double-blind trial. End points were change from baseline to week 26 in HbA 1c (primary) and body weight (confirmatory secondary). Two estimands were defined: treatment policy (effect regardless of trial product discontinuation or rescue medication) and trial product (effect assuming trial product continuation without rescue medication) in randomized patients.
RESULTS
Oral semaglutide was superior to placebo in reducing HbA 1c (estimated treatment difference [ETD] -0.5% [95% CI -0.7, -0.3], -0.9% [-1.1, -0.7], and -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P < 0.001) and body weight (ETD -0.9 kg [95% CI -1.8, -0.0], -2.0 kg [-3.0, -1.0], and -3.3 kg [-4.2, -2.3]; P = 0.0392 for 3 mg, P ≤ 0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand). Significantly greater dose-dependent HbA 1c and body weight reductions versus placebo were achieved with oral semaglutide at weeks 26 and 52 (both estimands). The most frequent adverse event with oral semaglutide was nausea (11.4-23.2% of patients vs. 7.1% with placebo; mostly mild to moderate).
CONCLUSIONS
Oral semaglutide was superior to placebo in reducing HbA 1c and body weight when added to insulin with or without metformin in patients with type 2 diabetes. The safety profile was consistent with other glucagon-like peptide 1 receptor agonists.",2019,"RESULTS
Oral semaglutide was superior to placebo in reducing HbA 1c (estimated treatment differences [ETD] [95% CI]: -0.5% [-0.7, -0.3], -0.9% [-1.1, -0.7], -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P <0.001) and body weight (ETD [95% CI]: -0.9 kg [-1.8, -0.0], -2.0 kg [-3.0, -1.0], -3.3 kg [-4.2, -2.3]; P =0.0392 for 3 mg, P ≤0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand).","['patients with type 2 diabetes', 'Patients with type 2 diabetes uncontrolled on insulin, ±', 'Patients with Type 2 Diabetes']","['insulin ± metformin', 'metformin', 'Insulin ± Metformin', 'oral semaglutide', 'Oral Semaglutide Versus Placebo', 'placebo', 'oral semaglutide added to insulin ± metformin']","['dose-dependent HbA 1c , and body weight reductions', 'HbA 1c and body weight', 'body weight', 'reducing HbA 1c', 'Efficacy, Safety and Tolerability', 'efficacy, safety and tolerability', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.109896,"RESULTS
Oral semaglutide was superior to placebo in reducing HbA 1c (estimated treatment differences [ETD] [95% CI]: -0.5% [-0.7, -0.3], -0.9% [-1.1, -0.7], -1.2% [-1.4, -1.0] for 3, 7, and 14 mg, respectively; P <0.001) and body weight (ETD [95% CI]: -0.9 kg [-1.8, -0.0], -2.0 kg [-3.0, -1.0], -3.3 kg [-4.2, -2.3]; P =0.0392 for 3 mg, P ≤0.0001 for 7 and 14 mg) at week 26 (treatment policy estimand).","[{'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada zinman@lunenfeld.ca.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology and Metabolism, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Cariou', 'Affiliation': ""Department of Endocrinology, L'Institut du Thorax, CIC INSERM 1413, CHU Nantes, Université de Nantes, Nantes, France.""}, {'ForeName': 'Stewart B', 'Initials': 'SB', 'LastName': 'Harris', 'Affiliation': 'Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Søren Tetens', 'Initials': 'ST', 'LastName': 'Hoff', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Karen Boje', 'Initials': 'KB', 'LastName': 'Pedersen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mads Jeppe', 'Initials': 'MJ', 'LastName': 'Tarp-Johansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Araki', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0898']
627,31746553,"Effects of Liraglutide and Behavioral Weight Loss on Food Cravings, Eating Behaviors, and Eating Disorder Psychopathology.","OBJECTIVE
This exploratory analysis examined the effects of intensive behavioral therapy (IBT) for obesity (""IBT-alone""), IBT plus liraglutide 3.0 mg/d (""IBT-liraglutide""), and IBT plus liraglutide 3.0 mg/d plus 12 weeks of a portion-controlled diet that provided 1,000 to 1,200 kcal/d (""Multicomponent"") on changes in food cravings, eating behaviors, and eating disorder psychopathology at 24 and 52 weeks post randomization.
METHODS
Adults with obesity (mean age = 47.6 ± 11.8 years and BMI = 38.4 ± 4.9 kg/m 2 ; 79.3% female; 54.0% non-Hispanic white; 44.7% black) were randomized to IBT-alone (n = 50), IBT-liraglutide (n = 50), or Multicomponent (n = 50).
RESULTS
At weeks 24 and 52, liraglutide-treated groups reported significantly larger declines in weight concern relative to the IBT-alone group. At week 24, compared with IBT-alone, liraglutide-treated groups reported significantly greater reductions in dietary disinhibition, global eating disorder psychopathology, and shape concern. The Multicomponent group had significantly greater reductions in binge eating at week 24 relative to the IBT-alone group. However, differences among groups were no longer significant at week 52. Groups did not differ in total food cravings at week 24 or 52.
CONCLUSIONS
The combination of liraglutide and IBT was associated with greater short-term improvements in dietary disinhibition, global eating disorder psychopathology, and shape concern than IBT alone.",2019,"The combination of liraglutide and IBT was associated with greater short-term improvements in dietary disinhibition, global eating disorder psychopathology, and shape concern than IBT alone.",['Adults with obesity (mean age\u2009=\u200947.6\u2009±\u200911.8 years and BMI\u2009=\u200938.4\u2009±\u20094.9 kg/m 2 ; 79.3% female; 54.0% non-Hispanic white; 44.7% black'],"['IBT-alone, liraglutide', 'IBT-alone', 'IBT-liraglutide', 'liraglutide and IBT', 'Liraglutide and Behavioral Weight Loss', 'IBT plus liraglutide 3.0 mg/d (""IBT-liraglutide""), and IBT plus liraglutide', 'intensive behavioral therapy (IBT']","['total food cravings', 'Food Cravings, Eating Behaviors, and Eating Disorder Psychopathology', 'binge eating', 'food cravings, eating behaviors, and eating disorder psychopathology', 'dietary disinhibition, global eating disorder psychopathology, and shape concern', 'dietary disinhibition, global eating disorder psychopathology', 'weight concern relative']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition, function (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0294901,"The combination of liraglutide and IBT was associated with greater short-term improvements in dietary disinhibition, global eating disorder psychopathology, and shape concern than IBT alone.","[{'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Olivia A', 'Initials': 'OA', 'LastName': 'Walsh', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jena S', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22653']
628,31762387,"Efficacy of alemtuzumab in relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies.","BACKGROUND
Alemtuzumab is given as two annual courses. Patients with continued disease activity may receive as-needed additional courses.
OBJECTIVE
To evaluate efficacy and safety of additional alemtuzumab courses in the CARE-MS (Comparison of Alemtuzumab and Rebif ® Efficacy in Multiple Sclerosis) studies and their extensions.
METHODS
Subgroups were based on the number of additional alemtuzumab courses received. Exclusion criteria: other disease-modifying therapy (DMT); <12-month follow-up after last alemtuzumab course.
RESULTS
In the additional-courses groups, Courses 3 and 4 reduced annualized relapse rate (12 months before: 0.73 and 0.74, respectively; 12 months after: 0.07 and 0.08). For 36 months after Courses 3 and 4, 89% and 92% of patients were free of 6-month confirmed disability worsening, respectively, with 20% and 26% achieving 6-month confirmed disability improvement. Freedom from magnetic resonance imaging (MRI) disease activity increased after Courses 3 and 4 (12 months before: 43% and 53%, respectively; 12 months after: 73% and 74%). Safety was similar across groups; serious events occurred irrespective of the number of courses.
CONCLUSION
Additional alemtuzumab courses significantly improved outcomes, without increased safety risks, in CARE-MS patients with continued disease activity after Course 2. How this compares to outcomes if treatment is switched to another DMT instead remains unknown.",2020,"Additional alemtuzumab courses significantly improved outcomes, without increased safety risks, in CARE-MS patients with continued disease activity after Course 2.","['Subgroups were based on the number of additional alemtuzumab courses received', 'Multiple Sclerosis', 'Exclusion criteria: other disease-modifying therapy (DMT); <12-month follow-up after last alemtuzumab course', 'relapsing-remitting MS patients who received additional courses after the initial two courses: Pooled analysis of the CARE-MS, extension, and TOPAZ studies']",['alemtuzumab'],"['annualized relapse rate', 'Safety', 'free of 6-month confirmed disability worsening', 'magnetic resonance imaging (MRI) disease activity', 'safety risks']","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0383429', 'cui_str': 'alemtuzumab'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0383429', 'cui_str': 'alemtuzumab'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332296', 'cui_str': 'Free of (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0996576,"Additional alemtuzumab courses significantly improved outcomes, without increased safety risks, in CARE-MS patients with continued disease activity after Course 2.","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Department of Neurology, University Vita-Salute San Raffaele, Milan, Italy.'}, {'ForeName': 'Raed', 'Initials': 'R', 'LastName': 'Alroughani', 'Affiliation': 'Department of Medicine, Amiri Hospital, Sharq, Kuwait.'}, {'ForeName': 'Aaron L', 'Initials': 'AL', 'LastName': 'Boster', 'Affiliation': 'OhioHealth Neurological Physicians, Columbus, OH, USA.'}, {'ForeName': 'Ann D', 'Initials': 'AD', 'LastName': 'Bass', 'Affiliation': 'Neurology Center of San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Berkovich', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA/Regina Berkovich, MD, PhD, Inc., West Hollywood, CA, USA.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Fernández', 'Affiliation': 'Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain.'}, {'ForeName': 'Ho Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Limmroth', 'Affiliation': 'Klinik für Neurologie und Palliativmedizin, Cologne, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lycke', 'Affiliation': 'Institute of Neuroscience and Physiology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Richard Al', 'Initials': 'RA', 'LastName': 'Macdonell', 'Affiliation': 'Department of Neurology, Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Singer', 'Affiliation': 'MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ. Lille, INSERM U995, CHU Lille, FHU Imminent, F-59000 Lille, France.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': 'Department of Neurology, University of Münster, Münster, Germany.'}, {'ForeName': 'Tjalf', 'Initials': 'T', 'LastName': 'Ziemssen', 'Affiliation': 'Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Jacobs', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Rodriguez', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Traboulsee', 'Affiliation': 'Division of Neurology, Department of Medicine, The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519888610']
629,29927279,A randomized controlled trial of distress tolerance treatment for smoking cessation.,"We previously developed a distress tolerance (DT)-based treatment that showed promising results for smokers with a history of early lapse. In the current study, we conducted a randomized controlled trial of this DT treatment for a general population of smokers not limited to those with a history of early lapse. We randomized 116 participants (41% female) to DT or standard treatment (ST). Both treatments included 1 individual session during Week 1 followed by 7 group sessions during Weeks 2-9 (quit date at Session 4), two 20-min phone sessions, and 8 weeks of transdermal nicotine patch. Results indicated no significant differences between conditions in the primary outcome of biochemically verified 7-day point prevalence smoking abstinence or in time to 1st lapse. Verified abstinence rates in DT were 38.7%, 38.7%, 46.77%, 40.32%, 20.9%, and 17.7% versus 40.7%, 37.0%, 53.7%, 44.4%, 33.3%, and 22.2% in ST at 1, 2, 4, 8, 13, and 26 weeks postquit, respectively. Additionally, we found no significant moderators of treatment efficacy and few differences in treatment process variables. These findings stand somewhat in contrast to those in our previous study and other recent studies of similar acceptance-based treatments. However, differences in methodology, inclusion of nicotine replacement therapy in both treatment conditions, and strict inclusion-exclusion criteria that excluded many smokers with affective vulnerabilities may underlie this discrepancy. Future research should evaluate the utility of DT and other acceptance-based treatments in populations with affective vulnerabilities who might specifically benefit from a DT-based approach. (PsycINFO Database Record",2018,Results indicated no significant differences between conditions in the primary outcome of biochemically verified 7-day point prevalence smoking abstinence or in time to 1st lapse.,"['general population of smokers not limited to those with a history of early lapse', 'smokers with a history of early lapse', 'smoking cessation', '116 participants (41% female) to']","['distress tolerance treatment', 'transdermal nicotine patch', 'DT or standard treatment (ST']","['Verified abstinence rates', '7-day point prevalence smoking abstinence or in time to 1st lapse']","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}]",116.0,0.0701277,Results indicated no significant differences between conditions in the primary outcome of biochemically verified 7-day point prevalence smoking abstinence or in time to 1st lapse.,"[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brown', 'Affiliation': 'Butler Hospital.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Palm Reed', 'Affiliation': 'Department of Psychology, Clark University.'}, {'ForeName': 'Erika Litvin', 'Initials': 'EL', 'LastName': 'Bloom', 'Affiliation': 'Butler Hospital.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Minami', 'Affiliation': 'Butler Hospital.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine, University of California, San Diego.'}, {'ForeName': 'Carl W', 'Initials': 'CW', 'LastName': 'Lejuez', 'Affiliation': 'College of Liberal Arts and Sciences, University of Kansas.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Hayes', 'Affiliation': 'Department of Psychology, University of Nevada, Reno.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000372']
630,31111801,Size matters: the importance of particle size in a newly developed injectable formulation for the treatment of schizophrenia.,"One of the challenges with initiating long-acting injectable (LAI) antipsychotic regimens is achieving relevant drug levels quickly. After first injection of the LAI antipsychotic aripiprazole lauroxil (AL), the lag to reaching relevant plasma aripiprazole levels was initially addressed using supplemental oral aripiprazole for 21 days. A 1-day AL initiation regimen using a NanoCrystal® Dispersion formulation of AL (ALNCD; Aristada Initio®) combined with a single 30 mg dose of oral aripiprazole has been developed as an alternative approach. We compared the 1-day AL initiation regimen (ALNCD + 30 mg oral aripiprazole for 1 day) with the 21-day AL initiation regimen (AL + 15 mg/day of oral aripiprazole for 21 days) using kinetic modeling. Observed and modeled data demonstrate that the 1-day AL initiation regimen provides continuous aripiprazole exposure comparable to the 21-day AL initiation regimen. Each component of the 1-day AL initiation regimen (30 mg oral aripiprazole, ALNCD, and AL) contributes to aripiprazole plasma levels at different times, with oral aripiprazole predominating in the first week, then ALNCD and AL over time. In a double-blind, placebo-controlled, phase 1 study in patients with schizophrenia, the 1-day initiation regimen resulted in rapid achievement of relevant plasma aripiprazole levels comparable to those from the 21-day initiation regimen. Safety and tolerability of the 1-day regimen were consistent with the known profile of aripiprazole. Each part of the 1-day initiation regimen, together with AL, is necessary for continuous aripiprazole exposure from treatment initiation until the next regularly scheduled AL injection is administered.",2020,Observed and modeled data demonstrate that the 1-day AL initiation regimen provides continuous aripiprazole exposure comparable to the 21-day AL initiation regimen.,['patients with schizophrenia'],"['placebo', '1-day AL initiation regimen (ALNCD + 30 mg oral aripiprazole', 'LAI antipsychotic aripiprazole lauroxil (AL', 'initiating long-acting injectable (LAI) antipsychotic regimens', 'aripiprazole']","['rapid achievement of relevant plasma aripiprazole levels', 'Safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0443021', 'cui_str': 'Lai (qualifier value)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0147806,Observed and modeled data demonstrate that the 1-day AL initiation regimen provides continuous aripiprazole exposure comparable to the 21-day AL initiation regimen.,"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Department of Psychiatry, Texas Tech University School of Medicine-Permian Basin, Midland, TX, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wehr', 'Affiliation': 'Clinical Pharmacology, Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Rege', 'Affiliation': 'Clinical Pharmacology, Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'von Moltke', 'Affiliation': 'Clinical Development, Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Medical Affairs, Alkermes, Inc., Waltham, MA, USA.'}]",CNS spectrums,['10.1017/S1092852919000816']
631,31567351,Ramelteon for Prevention of Postoperative Delirium: A Randomized Controlled Trial in Patients Undergoing Elective Pulmonary Thromboendarterectomy.,"OBJECTIVES
To assess the efficacy of ramelteon in preventing delirium, an acute neuropsychiatric condition associated with increased morbidity and mortality, in the perioperative, ICU setting.
DESIGN
Parallel-arm, randomized, double-blinded, placebo-controlled trial.
SETTING
Academic medical center in La Jolla, California.
PATIENTS
Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy.
INTERVENTIONS
Ramelteon 8 mg or matching placebo starting the night prior to surgery and for a maximum of six nights while in the ICU.
MEASUREMENTS AND MAIN RESULTS
Incident delirium was measured twice daily using the Confusion Assessment Method-ICU. The safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale. One-hundred twenty participants were enrolled and analysis completed in 117. Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516). Delirium duration, as assessed by the number of delirium-free days was also similar in both groups (placebo median 2 d [interquartile range, 2-3 d] vs ramelteon 3 d [2-5 d]; p = 0.181). Coma-free days was also similar between groups (placebo median 2 d [interquartile range, 1-3 d] vs ramelteon 3 d [2-4 d]; p = 0.210). We found no difference in ICU length of stay (median 4 d [interquartile range, 3-5 d] vs 4 d [3-6 d]; p = 0.349), or in-hospital mortality (four vs three deaths; relative risk ratio, 0.7; 95% CI, 0.2-3.2; p = 0.717), all placebo versus ramelteon, respectively.
CONCLUSIONS
Ramelteon 8 mg did not prevent postoperative delirium in patients admitted for elective cardiac surgery.",2019,"Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516).","['Postoperative Delirium', 'Academic medical center in La Jolla, California', 'Patients Undergoing Elective Pulmonary Thromboendarterectomy', 'Patients greater than or equal to 18 years undergoing elective pulmonary thromboendarterectomy', 'One-hundred twenty participants were enrolled and analysis completed in 117', 'patients admitted for elective cardiac surgery']","['placebo', 'Ramelteon 8 mg or matching placebo']","['ICU length of stay', 'postoperative delirium', 'hospital mortality', 'safety outcome was coma-free days assessed by the Richmond Agitation-Sedation Scale', 'number of delirium-free days', 'Delirium duration', 'Delirium']","[{'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1959997', 'cui_str': 'Pulmonary thromboendarterectomy (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1652106', 'cui_str': 'ramelteon 8 MG [Rozerem]'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1319200', 'cui_str': 'Postoperative confusion'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",120.0,0.772122,"Delirium occurred in 22 of 58 patients allocated to placebo versus 19 of 59 allocated to ramelteon (relative risk, 0.8; 95% CI, 0.5-1.4; p = 0.516).","[{'ForeName': 'Stuti J', 'Initials': 'SJ', 'LastName': 'Jaiswal', 'Affiliation': 'Scripps Research Translational Institute, La Jolla, CA.'}, {'ForeName': 'Anuja D', 'Initials': 'AD', 'LastName': 'Vyas', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Heisel', 'Affiliation': 'Division of Hospital Medicine, Scripps Clinic/Scripps Green Hospital, La Jolla, CA.'}, {'ForeName': 'Haritha', 'Initials': 'H', 'LastName': 'Ackula', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Ashna', 'Initials': 'A', 'LastName': 'Aggarwal', 'Affiliation': 'Scripps Research Translational Institute, La Jolla, CA.'}, {'ForeName': 'Nick H', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Kerr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Madani', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Pretorius', 'Affiliation': 'Division of Cardiovascular and Thoracic Surgery, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Auger', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Fernandes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego School of Medicine, La Jolla, CA.'}]",Critical care medicine,['10.1097/CCM.0000000000004004']
632,31754238,Exercise effects on arterial stiffness and heart health in children with excess weight: The SMART RCT.,"INTRODUCTION
Childhood obesity and inactivity are associated with cardiovascular risk. Evidence is limited for exercise effects on arterial health in children.
METHODS
One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity) were randomized to an 8-month daily after-school aerobic exercise program (40 min/day, n = 90) or a sedentary control condition (n = 85). Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein were measured at baseline and posttest (8 months). Adiposity, fitness, and BP were measured again at follow-up, 8-12 months later. Intent-to-treat analyses were conducted using mixed models.
RESULTS
The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161 ± 7 beats/min). Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2 peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001). There was no group × time effect on other outcomes at 8 months, or on any outcomes at follow-up. The change in PWV at 8 months correlated with changes in insulin and insulin resistance (both r = 0.32), diastolic BP (r = 0.24), BMI (r = 0.22), and adiposity (r = 0.18).
CONCLUSIONS
Eight months of aerobic exercise training improved fitness, adiposity, and HDL-cholesterol levels, but did not reduce arterial stiffness in children with excess weight. PWV improved as a function of insulin resistance, BP, BMI, and adiposity. Weight loss may be required to improve arterial stiffness. Exercise benefits waned after discontinuing the program.",2020,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2 peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","['children', 'children with excess weight', 'The study had 89% retention, with attendance of 59% in exercise and 64% in the control condition, and vigorous exercise participation (average heart rate 161\u2009±\u20097 beats/min', 'One hundred and seventy-five inactive children with overweight or obesity (8-11 years, ≥85th percentile BMI, 61% female, 87% Black, 73% with obesity']","['school aerobic exercise program (40\u2009min/day, n\u2009=\u200990) or a sedentary control condition', 'aerobic exercise training']","['insulin and insulin resistance', 'Adiposity, fitness, and BP', 'arterial stiffness', 'function of insulin resistance, BP, BMI, and adiposity', 'fitness, adiposity, and HDL-cholesterol levels', 'Weight loss', 'HDL-cholesterol', 'adiposity', 'arterial stiffness and heart health', 'diastolic BP', 'BMI', 'Carotid-femoral pulse wave velocity (PWV, primary outcome, arterial stiffness), fitness, adiposity, blood pressure (BP), glucose, insulin resistance, lipids, and C-reactive protein', 'change in PWV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439385', 'cui_str': 'beats per minute'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0556973', 'cui_str': 'mins/day'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",175.0,0.0968893,"Compared with controls, the exercise group had twice the improvement in fitness (VȮ 2 peak, 2.7 (95% CI 1.8, 3.6) vs. 1.3 (0.4, 2.3) mL/kg/min) and adiposity (-1.8 (-2.4, -1.1) vs. -0.8 (-1.5, -0.1)%), each p = 0.04, and a large improvement in HDL-cholesterol (0.13 (0.075, 0.186) vs. -0.028 (-0.083, 0.023) mmol/L, p < 0.0001).","[{'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Davis', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA. katie.davis@augusta.edu.'}, {'ForeName': 'Sheldon E', 'Initials': 'SE', 'LastName': 'Litwin', 'Affiliation': 'Cardiology, Medicine, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Norman K', 'Initials': 'NK', 'LastName': 'Pollock', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Waller', 'Affiliation': 'Population Health Sciences, MCG, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Kapuku', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jigar', 'Initials': 'J', 'LastName': 'Bhagatwala', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Harris', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Looney', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Celestine F', 'Initials': 'CF', 'LastName': 'Williams', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Armento', 'Affiliation': 'Georgia Prevention Institute, Medical College of Georgia (MCG), Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Schmidt', 'Affiliation': 'Kinesiology, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bassali', 'Affiliation': 'Pediatrics, MCG, Augusta University, Augusta, GA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0482-1']
633,31072087,Efficacy and Safety of Intra-articular Injections of Hyaluronic Acid Combined With Polydeoxyribonucleotide in the Treatment of Knee Osteoarthritis.,"OBJECTIVE
To assess the clinical efficacy and safety of intra-articular injection of hyaluronic acid (HA) combined with polydeoxyribonucleotide (PDRN) in patients with knee osteoarthritis in comparison with that of HA alone.
METHODS
The current single-center, prospective, randomized, double-blind, controlled study was conducted in 36 patients with knee osteoarthritis at our medical institution. All the eligible patients (n=30) were equally assigned to two treatment arms (trial group 'HA+PDRN' and control group 'HA'). For efficacy assessment, the patients were evaluated for the visual analogue scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Society Scores (KSS), all of which served as efficacy outcome measures. We monitored time-dependent changes in efficacy outcome measures at baseline and 1, 3 and 6 months. Subsequently, we compared differences in changes in efficacy outcome measures at 6 months from baseline between the two groups. Moreover, we assessed the safety based on the treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs) and any other complications serving as safety outcome measures.
RESULTS
There were significant differences in changes in the VAS scores, the WOMAC scores in all domains, except 'Stiffness', the total WOMAC scores, and the KSS scores in all the domains at 6 months from baseline between the two groups (p<0.05). In our series, there were no TEAEs, ADRs, and any other complications.
CONCLUSION
Intra-articular injections of HA combined with PDRN can also be considered in the treatment of knee osteoarthritis. However, further large-scale and multi-center studies are required to demonstrate the potential of the proposed combination.",2019,"There were significant differences in changes in the VAS scores, the WOMAC scores in all domains, except 'Stiffness', the total WOMAC scores, and the KSS scores in all the domains at 6 months from baseline between the two groups (p<0.05).","['Knee Osteoarthritis', 'patients with knee osteoarthritis in comparison with that of HA alone', 'eligible patients (n=30', '36 patients with knee osteoarthritis at our medical institution']","[""HA+PDRN' and control group 'HA"", 'hyaluronic acid (HA) combined with polydeoxyribonucleotide (PDRN', 'Hyaluronic Acid Combined With Polydeoxyribonucleotide', 'HA combined with PDRN']","['visual analogue scale (VAS) scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Society Scores (KSS', 'safety based on the treatment-emergent adverse events (TEAEs), adverse drug reactions (ADRs) and any other complications serving as safety outcome measures', 'VAS scores, the WOMAC scores', 'total WOMAC scores, and the KSS scores']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0032468', 'cui_str': 'Polydeoxyribonucleotides'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",36.0,0.0490441,"There were significant differences in changes in the VAS scores, the WOMAC scores in all domains, except 'Stiffness', the total WOMAC scores, and the KSS scores in all the domains at 6 months from baseline between the two groups (p<0.05).","[{'ForeName': 'Seihee', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Jung Joong', 'Initials': 'JJ', 'LastName': 'Kang', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Jungin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Seunghun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}, {'ForeName': 'Jong Moon', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.'}]",Annals of rehabilitation medicine,['10.5535/arm.2019.43.2.204']
634,31429944,Influence of pain anticipation on brain activity and pain perception in Gulf War Veterans with chronic musculoskeletal pain.,"Anticipation of a painful experience can influence brain activity and increase sensitivity to experimental somatosensory stimuli in healthy adults, but this response is poorly understood among individuals with chronic musculoskeletal pain (CMP). Studies of brain and perceptual responses to somatosensory stimuli are used to make inferences about central nervous system dysfunction as a potential mechanism of symptoms. As such, we sought to (a) determine the influence of pain anticipation on pain-relevant brain regions and pain perception, and (b) characterize potential differences in these responses between Gulf War Veterans with CMP and matched healthy control (CO) Veterans. CMP (N = 30) and CO Veterans (N = 31) were randomized to conditions designed to generate expectations that either painful (pain) or nonpainful (no pain) stimuli would be administered. Brain responses to five nonpainful thermal stimuli were measured during fMRI, and each stimulus was rated for pain intensity and unpleasantness. In the pain condition, an incremental linear decrease in activity across stimuli was observed in the posterior cingulate cortex, cingulate cortex, and middle temporal gyrus. Further, in the pain condition, differential responses were observed between CMP and CO Veterans in the middle temporal gyrus. These findings indicate that brain responses to nonpainful thermal stimuli in Veterans with CMP are sensitive to pain anticipation, and we recommend accounting for the influence of pain anticipation in future investigations of central nervous system dysfunction in CMP.",2019,"In the pain condition, an incremental linear decrease in activity across stimuli was observed in the posterior cingulate cortex, cingulate cortex, and middle temporal gyrus.","['Veterans with CMP', 'Gulf War Veterans with CMP and matched healthy control (CO) Veterans', 'N\xa0=\xa030) and CO Veterans (N\xa0=\xa031', 'healthy adults', 'individuals with chronic musculoskeletal pain (CMP', 'Gulf War Veterans with chronic musculoskeletal pain']","['pain anticipation', 'CMP', 'painful (pain) or nonpainful (no pain) stimuli']","['pain intensity and unpleasantness', 'brain activity and pain perception']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0010729', 'cui_str': 'Cytidylic Acid'}, {'cui': 'C1449761', 'cui_str': 'Gulf War'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010729', 'cui_str': 'Cytidylic Acid'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}]",,0.0220629,"In the pain condition, an incremental linear decrease in activity across stimuli was observed in the posterior cingulate cortex, cingulate cortex, and middle temporal gyrus.","[{'ForeName': 'Jacob B', 'Initials': 'JB', 'LastName': 'Lindheimer', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Stegner', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Ellingson-Sayen', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, Iowa.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Van Riper', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Dougherty', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Falvo', 'Affiliation': 'Department of Veterans Affairs, NJ Health Care System, War Related Illness and Injury Study Center, East Orange, New Jersey.'}, {'ForeName': 'Dane B', 'Initials': 'DB', 'LastName': 'Cook', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}]",Psychophysiology,['10.1111/psyp.13452']
635,31079555,Leucine metabolites do not attenuate training-induced inflammation in young resistance trained men.,"Leucine metabolites may reduce training-induced inflammation; however, there is scant evidence for this assertion. We conducted a double-blind randomized controlled pragmatic trial where 40 male participants were allocated into 4 groups: α-hydroxyisocaproic acid group ([α-HICA], n = 10, Fat-free mass [FFM] = 62.0 ± 7.1 kg), β-hydroxy-β-methylbutyrate free acid group ([HMB-FA], n = 11, FFM = 62.7 ± 10.5 kg), calcium β-hydroxy-β-methylbutyrate group ([HMB-Ca], n = 9, FFM = 65.6 ± 10.1 kg) or placebo group ([PLA]; n = 10, FFM = 64.2 ± 5.7 kg). An 8-week whole-body resistance training routine (3 training sessions per week) was employed to induce gains in skeletal-muscle thickness. Skeletal muscle thickness (MT), one repetition maximum (1RM), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP) and tumour necrosis factor alpha (TNF-α) were assessed at baseline and at the end of weeks 4 and 8. Time-dependent increases were detected from baseline to week 8 for MT (vastus lateralis: p = 0.009; rectus femoris: p = 0.018), 1RM (back squat: α-HICA, 18.5% ± 18.9%; HMB-FA, 23.2% ± 16%; HMB-Ca, 10.5% ± 13.8%; PLA, 19.7% ± 9% and bench press: α-HICA, 13.8% ± 19.1%; HMB-FA, 15.5% ± 9.3%; HMB-Ca, 10% ± 10.4%; PLA, 14.4 ± 11.3%, both p < 0.001), IL-6, hsCRP (both p < 0.001) and TNF-α (p = 0.045). No differences were found between groups at any time point. No leucine metabolite attenuated inflammation during training. Additionally, backwards elimination regressions showed that no circulating inflammatory marker consistently shared variance with the change in any outcome. Using leucine metabolites to modulate inflammation cannot be recommended from the results obtained herein. Furthermore, increases in inflammatory markers, from training, do not correlate with any outcome variable and are likely the result of training adaptations.",2019,"Skeletal muscle thickness (MT), one repetition maximum (1RM), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP) and tumour necrosis factor alpha (TNF-α) were assessed at baseline and at the end of weeks 4 and 8.","['young resistance trained men', '40 male participants']","['Leucine metabolites', 'α-hydroxyisocaproic acid group ([α-HICA], n =\xa010, Fat-free mass [FFM]\xa0=\xa062.0\xa0±\xa07.1 kg), β-hydroxy-β-methylbutyrate free acid group ([HMB-FA], n =\xa011, FFM\xa0=\xa062.7\xa0±\xa010.5 kg), calcium β-hydroxy-β-methylbutyrate group ([HMB-Ca], n =\xa09, FFM\xa0=\xa065.6\xa0±\xa010.1 kg) or placebo']","['Skeletal muscle thickness (MT), one repetition maximum (1RM), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP) and tumour necrosis factor alpha (TNF-α', 'inflammatory markers', 'IL-6, hsCRP']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",40.0,0.208553,"Skeletal muscle thickness (MT), one repetition maximum (1RM), interleukin-6 (IL-6), high-sensitivity C-reactive protein (hsCRP) and tumour necrosis factor alpha (TNF-α) were assessed at baseline and at the end of weeks 4 and 8.","[{'ForeName': 'Filipe J', 'Initials': 'FJ', 'LastName': 'Teixeira', 'Affiliation': 'a Laboratory of Physiology and Biochemistry of Exercise, Faculty of Human Kinetics , Universidade de Lisboa , Cruz Quebrada , Portugal.'}, {'ForeName': 'Catarina N', 'Initials': 'CN', 'LastName': 'Matias', 'Affiliation': 'a Laboratory of Physiology and Biochemistry of Exercise, Faculty of Human Kinetics , Universidade de Lisboa , Cruz Quebrada , Portugal.'}, {'ForeName': 'Cristina P', 'Initials': 'CP', 'LastName': 'Monteiro', 'Affiliation': 'a Laboratory of Physiology and Biochemistry of Exercise, Faculty of Human Kinetics , Universidade de Lisboa , Cruz Quebrada , Portugal.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Valamatos', 'Affiliation': 'c Center for the Study of Human Performance, Faculty of Human Kinetics , Universidade de Lisboa , Cruz Quebrada , Portugal.'}, {'ForeName': 'Joana F', 'Initials': 'JF', 'LastName': 'Reis', 'Affiliation': 'a Laboratory of Physiology and Biochemistry of Exercise, Faculty of Human Kinetics , Universidade de Lisboa , Cruz Quebrada , Portugal.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Morton', 'Affiliation': 'f Department of Kinesiology , McMaster University , Hamilton , ON , Canada.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alves', 'Affiliation': 'a Laboratory of Physiology and Biochemistry of Exercise, Faculty of Human Kinetics , Universidade de Lisboa , Cruz Quebrada , Portugal.'}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': 'b Laboratory of Exercise and Health, Faculty of Human Kinetics , Universidade de Lisboa , Cruz Quebrada , Portugal.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Phillips', 'Affiliation': 'f Department of Kinesiology , McMaster University , Hamilton , ON , Canada.'}]",Journal of sports sciences,['10.1080/02640414.2019.1617503']
636,31740476,Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from episodic insomnia to persistent insomnia: study protocol for a randomised controlled trial.,"INTRODUCTION
Previous evidence suggested that online self-guided sleep intervention is efficacious in improving treatment outcomes in patients with persistent insomnia. However, research on online sleep interventions targeting episodic insomnia has been scarce. This study aims to evaluate the effectiveness of brief e-aid cognitive behavioural therapy for insomnia (eCBTI) in preventing transition from episodic insomnia to persistent insomnia.
METHODS AND ANALYSIS
This is a pragmatic two-arm multicentre, randomised controlled trial comparing eCBTI with treatment as usual (TAU) in outpatients. Two hundred patients with episodic insomnia (as defined by DSM-5) will be recruited. Patients will be randomly assigned to receive 1 week eCBTI via a Smartphone application, or to receive TAU. Treatment effects will be assessed at 1 week and 3 months after intervention. The primary outcome of the study, whether the eCBTI program is sufficient in preventing transition from short-term to persistent insomnia, is measured by the Insomnia Severity Index. Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale. Additionally, the Hospital Anxiety and Depression Scale and the Short-Form 12-Item Health Survey will be used for measurement of mood symptoms and quality of life.
ETHICS AND DISSEMINATION
Ethical approval for the study has been obtained from the Ethics Committee of Southern Medical University (reference number: NFEC-2017-131). The results of the investigation will be published in scientific papers. The data from the investigation will be made available online if necessary.
TRIAL REGISTRATION
NCT03302455 (clinicaltrials.gov). Date of registration: October 5, 2017.",2019,"Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale.","['Two hundred patients with episodic insomnia (as defined by DSM-5) will be recruited', 'patients with persistent insomnia', 'outpatients']","['e-aid cognitive behavioural therapy', 'brief e-aid cognitive behavioural therapy', 'online self-guided sleep intervention', 'eCBTI', '1\u2009week eCBTI via a Smartphone application, or to receive TAU']","['Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale', 'preventing transition from short-term to persistent insomnia, is measured by the Insomnia Severity Index', 'Hospital Anxiety and Depression Scale', 'mood symptoms and quality of life']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",200.0,0.159507,"Secondary outcome measurements include the Dysfunctional Beliefs and Attitudes about Sleep Scale, Ford Insomnia Response to Stress Test, Sleep Hygiene and Practices Scale, Pre-sleep Arousal Scale and Epworth Sleepiness Scale.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Dhirendra', 'Initials': 'D', 'LastName': 'Paudel', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China.'}, {'ForeName': 'Jihui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Shirley Xin', 'Initials': 'SX', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Southern Medical University Nanfang Hospital, Guangzhou, China zhang73bin@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-033457']
637,31030296,N-Acetyl cysteine does not improve repeated intense endurance cycling performance of well-trained cyclists.,"PURPOSE
To evaluate the effect of antioxidant supplementation on intense endurance exercise performance and the physiologic exercise response acutely and in early recovery.
METHODS
Well-trained cyclists (n = 11, peak VO 2 : 69 ± 7 ml/min/kg) completed two identical standardized 20-min warm-up periods (WU-1 and WU-2) prior to two performance tests (PT) with a duration of ~ 4 min representing a qualifying (PT-1) and final race (PT-2) on the same day separated by 90 min. Subjects were supplemented orally with placebo (PLA) and N-acetyl cysteine (NAC; 20 mg/kg) before exercise in a double-blinded crossover design.
RESULTS
Mean power during PT-1 did not differ (P = 0.39) between PLA (400 ± 44 W) and NAC (401 ± 44 W) as was the case during PT-2 with similar performance (P = 0.74) between PLA (401 ± 43 W) and NAC (400 ± 42 W). Subjective ""readiness"" was lowered by prior exhaustive exercise from PT-1 to PT-2 (P = 0.012) in both PLA and NAC. Plasma total antioxidant capacity was not affected by supplementation and prior exhaustive exercise (respective main effects: P = 0.83 and P = 0.19) which also was observed for peak VO 2 at ~ 5 L/min (P = 0.84 and P = 0.30). In WU-1 and WU-2, both cycling economy at ~ 20% (P = 0.10 and P = 0.21) and plasma potassium at ~ 5 mmol/L (P = 0.46 and P = 0.26) were unaffected by supplementation and prior exercise.
CONCLUSIONS
Athletes executing maximal efforts of a ~ 4-min duration twice daily, as seen in track cycling, appear to gain no benefit from oral NAC supplementation on acute and subsequent performance following short-term recovery. Moreover, well-trained cyclists exhibit rapid recovery from a single bout of intense endurance cycling.",2019,Plasma total antioxidant capacity was not affected by supplementation and prior exhaustive exercise (respective main effects: P = 0.83 and P = 0.19) which also was observed for peak VO 2 at ~ 5 L/min (P = 0.84 and P = 0.30).,"['Well-trained cyclists (n\u2009=\u200911, peak VO 2 : 69\u2009±']","['7\xa0ml/min/kg) completed two identical standardized 20-min warm-up periods (WU-1 and WU-2) prior to two performance tests (PT) with a duration of ~\u20094\xa0min representing a qualifying (PT-1) and final race (PT-2', 'placebo (PLA) and N-acetyl cysteine (NAC; 20\xa0mg/kg) before exercise', 'antioxidant supplementation', 'N-Acetyl cysteine']","['intense endurance exercise performance', 'Subjective ""readiness', 'Plasma total antioxidant capacity', 'plasma potassium']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}]","[{'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0585043', 'cui_str': 'Before exercise (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0858155', 'cui_str': 'Plasma potassium'}]",,0.226982,Plasma total antioxidant capacity was not affected by supplementation and prior exhaustive exercise (respective main effects: P = 0.83 and P = 0.19) which also was observed for peak VO 2 at ~ 5 L/min (P = 0.84 and P = 0.30).,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, August Krogh Institute, University of Copenhagen, Universitetsparken 13, 2100, Copenhagen Ø, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, August Krogh Institute, University of Copenhagen, Universitetsparken 13, 2100, Copenhagen Ø, Denmark. jbangsbo@nexs.ku.dk.'}]",European journal of applied physiology,['10.1007/s00421-019-04132-7']
638,31742796,Changes in Coping and Negative Cognitions as Mechanisms of Change in Online Treatment for Rape-Related Posttraumatic Stress Disorder.,"Cognitive behavioral therapy (CBT)-based interventions, including those administered via telepsychology, represent efficacious posttraumatic stress disorder (PTSD) treatments. Despite demonstrated efficacy, limited research has examined mechanisms of change for CBT. We examined trauma-related cognitions and coping as treatment mechanisms among 46 women who completed a randomized clinical trial of a CBT-based, telepsychology-delivered interactive program for rape survivors. The results indicated that both the interactive program, d = 1.5, and the active control condition, a psychoeducational website, d = 1.4, resulted in large reductions in posttest PTSD symptoms. Analysis of residual gain scores showed that reductions in the three types of assessed trauma-related cognitions were strongly related to reductions in PTSD symptoms among women assigned to the interactive program, rs = .60-.79, but only weakly related to symptom reduction among those assigned to active control, rs = .06-.31. The results also suggest that increases in trauma-related approach coping were weakly related to reductions in PTSD symptoms among participants in the interactive program, rs = -.16 and -.17, but, conversely, decreases in trauma-related approach coping were weakly related to reductions in PTSD symptoms among those in the active control group, rs = .07 and .28. Reductions in avoidance coping were modestly related to reductions in PTSD symptoms among women in the interactive program, rs = .38 and .38, but unrelated to changes in PTSD symptoms among those assigned to the active control, rs = .03 and .05. Implications for future work examining mechanisms of change for PTSD treatments are discussed.",2019,"Reductions in avoidance coping were modestly related to reductions in PTSD symptoms among women in the interactive program, rs = .38 and .38, but unrelated to changes in PTSD symptoms among those assigned to the active control, rs = .03 and .05.",['46 women who completed a randomized clinical trial of a'],"['CBT-based, telepsychology-delivered interactive program', 'Cognitive behavioral therapy (CBT)-based interventions']","['trauma-related approach coping', 'PTSD symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",46.0,0.0150497,"Reductions in avoidance coping were modestly related to reductions in PTSD symptoms among women in the interactive program, rs = .38 and .38, but unrelated to changes in PTSD symptoms among those assigned to the active control, rs = .03 and .05.","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Littleton', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Grills', 'Affiliation': 'School of Education, Boston University, Boston, Massachusetts, USA.'}]",Journal of traumatic stress,['10.1002/jts.22447']
639,31038394,The effects of a physical inactivity-related health risk message intervention on changes in risk perceptions and physical activity in middle-aged women.,"The study investigated the effects of the physical inactivity-related health risk message intervention on changes in risk perception for diseases. Forty-one women participated in the 16-week intervention. During this period, the study participants' physical activity, risk perceptions, and objective risk factors were measured. Results indicated that the intervention had a significant effect on improving perceived health risk of heart disease and obesity. Moreover, changes in perceived risk showed significant effect on changes in physical activity over the 16-week intervention. The study provided both theoretical and practical implications for perceived health risk as a predictor of physical activity.",2020,"Moreover, changes in perceived risk showed significant effect on changes in physical activity over the 16-week intervention.","['middle-aged women', 'Forty-one women participated in the 16-week intervention']",['physical inactivity-related health risk message intervention'],"['physical activity', 'risk perceptions and physical activity', 'health risk of heart disease and obesity', 'physical activity, risk perceptions, and objective risk factors']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",41.0,0.0157063,"Moreover, changes in perceived risk showed significant effect on changes in physical activity over the 16-week intervention.","[{'ForeName': 'Youngho', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Sport Science, Seoul National University of Science and Technology , Seoul, Korea.'}]",Journal of women & aging,['10.1080/08952841.2019.1607678']
640,28007665,CD25 Blockade Delays Regulatory T Cell Reconstitution and Does Not Prevent Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation.,"Daclizumab, a humanized monoclonal antibody, binds CD25 and blocks formation of the IL-2 receptor on T cells. A study of daclizumab as acute graft-versus-host disease (GVHD) prophylaxis after unrelated bone marrow transplantation was conducted before the importance of CD25 + FOXP3 + regulatory T cells (Tregs) was recognized. Tregs can abrogate the onset of GVHD. The relation between Tregs and a graft-versus-malignancy effect is not fully understood. An international, multicenter, double-blind clinical trial randomized 210 adult or pediatric patients to receive 5 weekly doses of daclizumab at 0.3 mg/kg (n = 69) or 1.2 mg/kg (n = 76) or placebo (n = 65) after unrelated marrow transplantation for treatment of hematologic malignancies or severe aplastic anemia. The risk of acute GVHD did not differ among the groups (P = .68). Long-term follow-up of clinical outcomes and correlative analysis of peripheral blood T cell phenotype suggested that the patients treated with daclizumab had an increased risk of chronic GVHD (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.0 to 2.3; P = .08) and a decreased risk of relapse (HR, 0.57; 95% CI, 0.3 to 1.0; P = .05), but similar survival (HR, 0.89; 95% CI, 0.6 to 1.3; P = .53). T cells from a subset of patients (n = 107) were analyzed by flow cytometry. Compared with placebo, treatment with daclizumab decreased the proportion of Tregs among CD4 T cells at days 11-35 and increased the proportion of central memory cells among CD4 T cells at 1 year. Prophylactic administration of daclizumab does not prevent acute GVHD, but may increase the risk of chronic GVHD and decrease the risk of relapse. By delaying Treg reconstitution and promoting immunologic memory, anti-CD25 therapy may augment alloreactivity and antitumor immunity.",2017,The risk of acute GVHD did not differ among the groups (P = .68).,"['210 adult or pediatric patients', 'acute graft-versus-host disease (GVHD) prophylaxis after unrelated bone marrow transplantation']","['Allogeneic Hematopoietic Cell Transplantation', 'Daclizumab', 'placebo', 'daclizumab']","['risk of chronic GVHD', 'risk of acute GVHD', 'risk of relapse', 'proportion of Tregs among CD4 T cells', 'similar survival', 'proportion of central memory cells']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0005961', 'cui_str': 'Grafting, Bone Marrow'}]","[{'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}, {'cui': 'C0663182', 'cui_str': 'Daclizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0312737', 'cui_str': 'Memory cell'}]",210.0,0.327533,The risk of acute GVHD did not differ among the groups (P = .68).,"[{'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Locke', 'Affiliation': 'Blood and Marrow Transplantation Program, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pidala', 'Affiliation': 'Blood and Marrow Transplantation Program, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Storer', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Martin', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington; Department of Medicine, Division of Oncology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Pulsipher', 'Affiliation': 'Blood and Marrow Transplant Program, Huntsman Cancer Institute, University of Utah Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Chauncey', 'Affiliation': 'Department of Medicine, Division of Oncology, University of Washington, Seattle, Washington; Cancer Care Division, VA Puget Sound Health Care System, Seattle, Washington.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Hematology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Stem Cell Transplantation, Center of Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Walker', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Light', 'Affiliation': 'Hoffman LaRoche, Nutley, New Jersey.'}, {'ForeName': 'Bronwen E', 'Initials': 'BE', 'LastName': 'Shaw', 'Affiliation': 'Haemato-Oncology Unit, Royal Marsden Hospital, Sutton, United Kingdom.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Beato', 'Affiliation': 'Blood and Marrow Transplantation Program, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Ginna G', 'Initials': 'GG', 'LastName': 'Laport', 'Affiliation': 'Division of Blood and Marrow Transplantation, Stanford University, Stanford, California.'}, {'ForeName': 'Auayporn', 'Initials': 'A', 'LastName': 'Nademanee', 'Affiliation': 'Hematologic Malignancies and Stem Cell Transplantation Institute, City of Hope, Duarte, California.'}, {'ForeName': 'Armand', 'Initials': 'A', 'LastName': 'Keating', 'Affiliation': 'Blood and Marrow Transplant Centre, Department of Hematology, Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Socie', 'Affiliation': 'Department of Hematology/Transplantation, Hospital Saint Louis, Paris, France.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Anasetti', 'Affiliation': 'Blood and Marrow Transplantation Program, Moffitt Cancer Center, Tampa, Florida. Electronic address: claudio.anasetti@moffitt.org.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2016.12.624']
641,31734699,Effectiveness and Safety of an Inactivated Enterovirus 71 Vaccine in Children Aged 6-71 Months in a Phase IV Study.,"BACKGROUND
Evaluation of a licensed inactivated enterovirus type 71 (EV71) vaccine is needed in a phase IV study with a large population to identify its effectiveness and safety for further application.
METHODS
An open-label, controlled trial involving a large population of 155 995 children aged 6-71 months was performed; 40 724 were enrolled in the vaccine group and received 2 doses of inactivated EV71 vaccine at an interval of 1 month, and the remaining children were used as the control group. The EV71-infected cases with hand, foot, and mouth disease were monitored in the vaccine and control groups during a follow-up period of 14 months since the 28th day postinoculation through the local database of the Notifiable Infectious Diseases Network. The effectiveness of the vaccine was estimated by comparing the incidence density in the vaccine group versus that in the control group based upon EV71-infected patients identified via laboratory testing. In parallel, the active and passive surveillance for safety of the vaccine was conducted by home or telephone visits and by using the Adverse Event Following Immunization (AEFI) system, respectively.
RESULTS
An overall level of 89.7% (95% confidence interval, 24.0-98.6%) vaccine effectiveness against EV71 infection and a 4.58% rate of reported adverse events were observed. Passive surveillance demonstrated a 0.31% rate of reported common minor reactions.
CONCLUSIONS
The clinical protection and safety of the EV71 vaccine were demonstrated in the immunization of a large population.
CLINICAL TRIALS REGISTRATION
NCT03001986.",2020,"The EV71-infected hand, foot and mouth disease (HFMD) cases were monitored in the vaccine and control groups during a follow-up period of 14 months since the 28th days post inoculation through the local database of Notifiable Infectious Diseases Network.","['155,995 children aged 6-71 months is performed; 40,724 were enrolled in the', 'children aged 6-71 months in a phase IV study']","['inactivated enterovirus 71 vaccine', 'vaccine group and received 2 doses of inactivated EV71 vaccine', 'EV71 vaccine']","['Effectiveness and safety', 'incidence density', 'vaccine effectiveness (VE) against EV71 infection']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0793962,"The EV71-infected hand, foot and mouth disease (HFMD) cases were monitored in the vaccine and control groups during a follow-up period of 14 months since the 28th days post inoculation through the local database of Notifiable Infectious Diseases Network.","[{'ForeName': 'Xuhua', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Che', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Xiangyang Health Commission, Xiangyang, China.'}, {'ForeName': 'Zhimei', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Yeqing', 'Initials': 'Y', 'LastName': 'Tong', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Xiangyang Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Yanting', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Siquan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Ruiju', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Xiangyang Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Xingzhou', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Xiangyang Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Wangsheng', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Xiangyang Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Dai', 'Affiliation': 'Hubei Provincial Center for Disease Control and Prevention, Wuhan, China.'}, {'ForeName': 'Guorun', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Min', 'Affiliation': 'Xiangyang Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Xiangyang Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Xijun', 'Initials': 'X', 'LastName': 'You', 'Affiliation': 'Xiangyang Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Xingli', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Xiangzhou County Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Changhui', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Xiangzhou County Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Shengtao', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}, {'ForeName': 'Lianju', 'Initials': 'L', 'LastName': 'Hang', 'Affiliation': 'Xiangzhou County Center for Disease Control and Prevention, Xiangyang, China.'}, {'ForeName': 'Qiaoxin', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Xiangyang Hospital of Infectious Diseases, Xiangyang, China.'}, {'ForeName': 'Qihan', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Yunnan Key Laboratory of Vaccine Research and Development on Severe Infectious Diseases, Institute of Medical Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Kunming, China.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1114']
642,31060632,"Predictors of functional response and remission with desvenlafaxine 50 mg and 100 mg: a pooled analysis of randomized, placebo-controlled studies in patients with major depressive disorder.","OBJECTIVE
The value of early functional improvement at week 2 for predicting subsequent functional outcomes at week 8 was assessed in a pooled analysis of patients with major depressive disorder (MDD) treated with desvenlafaxine (50 or 100 mg/d) or placebo.
METHODS
Data were pooled from eight double-blind, placebo-controlled studies of desvenlafaxine 50 mg/d or 100 mg/d for the treatment of MDD. Optimal week-2 improvement thresholds in Sheehan Disability Scale (SDS) score, which best predicted week-8 treatment success, were determined using receiver operating characteristic (ROC) analysis. Four definitions of treatment success were established: (1) functional response, (2) functional/depression response, (3) functional remission, and (4) functional/depression remission. Odds ratios (ORs) of early improvement for prediction (based on thresholds determined in the ROC analysis) of week-8 treatment success were computed using logistic regression models.
RESULTS
Functional early improvement thresholds of 17%-32% were predictive of week-8 treatment success across treatment groups and definitions of treatment success. Optimal thresholds were higher for more stringent definitions. Negative predictive value exceeded positive predictive value, indicating that failure to achieve early functional improvement was more informative about later treatment success than was the achievement of early functional improvement. Early change in SDS was a highly significant predictor of functional response/remission (ORs, 4.981-8.737; all p < 0.0001); the interaction between treatment and early functional improvement was not significant.
CONCLUSION
Early improvement in SDS total score was predictive of functional outcomes for patients treated with desvenlafaxine 50 mg, desvenlafaxine 100 mg, or placebo.",2020,"Early improvement in SDS total score was predictive of functional outcomes for patients treated with desvenlafaxine 50 mg, desvenlafaxine 100 mg, or placebo.","['patients with major depressive disorder (MDD) treated with', 'patients with major depressive disorder']","['desvenlafaxine 50\xa0mg', 'placebo', 'desvenlafaxine']","['Odds ratios (ORs) of early improvement for prediction', 'Sheehan Disability Scale (SDS) score', 'SDS total score', 'functional response/remission', 'functional response, (2) functional/depression response, (3) functional remission, and (4) functional/depression remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3665176', 'cui_str': 'Desvenlafaxine 50 MG [Khedezla]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.143237,"Early improvement in SDS total score was predictive of functional outcomes for patients treated with desvenlafaxine 50 mg, desvenlafaxine 100 mg, or placebo.","[{'ForeName': 'Claudio N', 'Initials': 'CN', 'LastName': 'Soares', 'Affiliation': ""Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Dalia B', 'Initials': 'DB', 'LastName': 'Wajsbrot', 'Affiliation': 'Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boucher', 'Affiliation': 'Pfizer Canada Inc, Kirkland, QC, Canada.'}]",CNS spectrums,['10.1017/S1092852919000828']
643,31793231,Lack of Effect of Rezafungin on QT/QTc Interval in Healthy Subjects.,"Rezafungin is a new echinocandin in development for treatment of candidemia and invasive candidiasis, and for prophylaxis of invasive fungal infections. Rezafungin is the first echinocandin to undergo definitive QT/QTc study. This phase 1, single-center, randomized, double-blind trial was conducted to assess effects of intravenous rezafungin vs intravenous placebo (with moxifloxacin as positive control) on the QT interval of the electrocardiogram, corrected for heart rate by Fridericia's formula (QTcF), in healthy adults. Therapeutic (600 mg) and supratherapeutic (1400 mg) rezafungin doses were selected to achieve exposures 2.5-fold higher than produced by the highest dose used in a phase 2 trial (400 mg once weekly). The primary end point was change in QTcF from baseline (ΔQTcF) as a function of plasma concentration, assessed by comparing upper bounds of the 2-sided 90% confidence interval. The estimated mean ΔΔQTcF at the mean plasma concentrations for the rezafungin doses had upper bounds <10 milliseconds, within the upper bound of the 2-sided 90% confidence interval. Intravenous rezafungin up to 1400 mg in a single dose did not prolong QT interval and had no apparent effect on repolarization or QRS duration. Electrocardiogram results showed no clinically significant effects of concern. These findings support the continued development of rezafungin.",2020,Intravenous rezafungin up to 1400 mg in a single dose did not prolong QT interval and had no apparent effect on repolarization or QRS duration.,"['Healthy Subjects', 'healthy adults']","['Intravenous rezafungin', 'Rezafungin', 'rezafungin vs intravenous placebo (with moxifloxacin', 'supratherapeutic (1400\xa0mg) rezafungin']","['mean plasma concentrations', 'QT interval', 'change in QTcF from baseline (ΔQTcF) as a function of plasma concentration', 'repolarization or QRS duration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.104894,Intravenous rezafungin up to 1400 mg in a single dose did not prolong QT interval and had no apparent effect on repolarization or QRS duration.,"[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Flanagan', 'Affiliation': 'Cidara Therapeutics Inc., San Diego, California, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Goodman', 'Affiliation': 'BioTelemetry Research, Rockville, Maryland, USA.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Jandourek', 'Affiliation': 'Cidara Therapeutics Inc., San Diego, California, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion, Inc., Tempe, Arizona, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Sandison', 'Affiliation': 'Cidara Therapeutics Inc., San Diego, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.757']
644,31735996,Effect of eccentric-based rehabilitation on hand tremor intensity in Parkinson disease.,"BACKGROUND AND PURPOSE
Hand tremor is a disturbing yet sometimes resistant symptom in persons with Parkinson disease (PD). Although many exercise regimens for these people have gained attention in recent years, the effect of resistance training and especially eccentric training on parkinsonian tremor is still uncertain. This study was conducted to investigate the precise effect of upper limb eccentric training on hand tremor in PD.
METHODS
In this randomized controlled trial, a consecutive sample of 21 persons with PD recruited from general hospitals went through 6 weeks of upper limb pure eccentric training as the intervention group (n = 11) or no additional exercise during this period as the control group (n = 10). Resting and postural tremor amplitudes were measured with the cellphone-based accelerometer.
RESULTS
Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study. Meanwhile, postural tremor amplitude remained unchanged in both groups.",2020,"RESULTS
Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study.","['21 persons with PD recruited from general hospitals went through 6 weeks of', 'persons with Parkinson disease (PD', 'Parkinson disease']","['eccentric-based rehabilitation', 'eccentric training', 'upper limb pure eccentric training as the intervention group (n = 11) or no additional exercise', 'upper limb eccentric training']","['resting tremor amplitude', 'Resting and postural tremor amplitudes', 'Meanwhile, postural tremor amplitude']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0234379', 'cui_str': 'Resting Tremor'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234378', 'cui_str': 'Static Tremor'}]",21.0,0.0179724,"RESULTS
Comparing hand tremor amplitudes before and after the trial showed a significant reduction in resting tremor amplitude in the intervention group after exercise sessions (p < 0.05) while detecting no changes in the control group during 6 weeks of study.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kadkhodaie', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sharifnezhad', 'Affiliation': 'Department of Sport Biomechanics and Technology, Sport Sciences Research Institute, No 3, Alley 5, Mir Emad St., Motahari St., Tehran, Iran. a.sharifnezhad@ssrc.ac.ir.'}, {'ForeName': 'Safoora', 'Initials': 'S', 'LastName': 'Ebadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Marzban', 'Affiliation': 'Department of Biomedical Engineering, Amirkabir University of Technology, Tehran, Iran.'}, {'ForeName': 'Seyed Amirhassan', 'Initials': 'SA', 'LastName': 'Habibi', 'Affiliation': 'Department of Neurology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Ghaffari', 'Affiliation': 'School of Rehabilitation Science, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Forogh', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Firoozgar Hospital, Behafarin St., Karim Khan St., Tehran, Iran. bijanfr@gmail.com.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04106-9']
645,31062692,Outcomes of bioresorbable vascular scaffolds versus everolimus-eluting stents by coronary complexity: a sub-analysis of the AIDA trial.,"AIMS
We aimed to evaluate the impact of the complexity of coronary disease as assessed by the SYNTAX score (SXscore) on the clinical outcomes in the AIDA trial.
METHODS AND RESULTS
In the AIDA trial, we compared Absorb versus XIENCE in routine clinical practice. Clinical outcomes were stratified by SXscore tertiles: SXlow (SXscore ≤8), SXmid (SXscore >8 and ≤15) and SXhigh (>15). The SXscore was available in 1,661 of the 1,845 (90%) patients. The event rate of TVF was numerically lower in Absorb compared to XIENCE (3.7% versus 5.6%; p=0.257) in the SXlow tertile, numerically higher in Absorb in the SXmid tertile (11.4% versus 9.3%, p=0.421) and similar in the SXhigh tertile (15.5% versus 15.6%; p=0.960). The rates of definite/probable device thrombosis in Absorb versus XIENCE were significantly higher in the SXmid tertile (3.3% versus 0.8%, p=0.043) and in the SXhigh tertile (3.7% versus 0.8%, p=0.006).
CONCLUSIONS
We found no significantly different rates of TVF between Absorb and XIENCE patients. Absorb-treated patients in the SXmid and SXhigh tertiles had an increased risk of device thrombosis when compared to XIENCE-treated patients. The rates of device thrombosis in the SXlow tertile, while still higher for Absorb, are more acceptable than in the SXmid and SXhigh score tertiles.",2020,"The rates of definite/probable device thrombosis in Absorb versus Xience were significantly higher in the Sxmid tertile (3.3% versus 0.8%, p=0.043) and in the SXhigh tertile (3.7% versus 0.8%, p=0.006)",[],"['Bioresorbable vascular scaffold versus Xience metallic stents', 'SYNTAX score (SXscore']","['rates of TVF', 'risk of device thrombosis', 'Event rate of TVF', 'rates of definite/probable device thrombosis', 'rates of device thrombosis', 'myocardial revascularization and revascularization rates']",[],"[{'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0027056', 'cui_str': 'Myocardial Revascularization'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",,0.0641697,"The rates of definite/probable device thrombosis in Absorb versus Xience were significantly higher in the Sxmid tertile (3.3% versus 0.8%, p=0.043) and in the SXhigh tertile (3.7% versus 0.8%, p=0.006)","[{'ForeName': 'Robin P', 'Initials': 'RP', 'LastName': 'Kraak', 'Affiliation': 'Amsterdam UMC and AMC Heart Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ruben Yannick G', 'Initials': 'RYG', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': ''}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': ''}, {'ForeName': 'Sjoerd H', 'Initials': 'SH', 'LastName': 'Hofma', 'Affiliation': ''}, {'ForeName': 'Rene J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': ''}, {'ForeName': 'E Karin', 'Initials': 'EK', 'LastName': 'Arkenbout', 'Affiliation': ''}, {'ForeName': 'Auke', 'Initials': 'A', 'LastName': 'Weevers', 'Affiliation': ''}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ''}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': ''}, {'ForeName': 'Robbert J', 'Initials': 'RJ', 'LastName': 'de Winter', 'Affiliation': ''}, {'ForeName': 'Jose P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': ''}, {'ForeName': 'Joanna J', 'Initials': 'JJ', 'LastName': 'Wykrzykowska', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-18-00884']
646,31852712,"Ascorbic Acid, Corticosteroids and Thiamine in Sepsis (ACTS) protocol and statistical analysis plan: a prospective, multicentre, double-blind, randomised, placebo-controlled clinical trial.","INTRODUCTION
Septic shock is a common and highly morbid condition. To date, there is no specific therapy proven to attenuate organ injury in septic shock. Recent studies have suggested a role for the combination of ascorbic acid, corticosteroids and thiamine, although randomised data are lacking.
METHODS AND ANALYSIS
The Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis trial is a multi-centre, double-blind, randomised, placebo-controlled clinical trial that aims to determine the impact of ascorbic acid, corticosteroids and thiamine versus placebo on organ injury and mortality in patients with septic shock. Patients are randomised to receive 1500 mg of ascorbic acid, 100 mg of thiamine and 50 mg of hydrocortisone parenterally versus matching placebo every 6 hours for 4 days. Clinical and laboratory data are collected at the time of study enrolment, at 24, 72 and 120 hours. The primary end-point for the trial is change in the Sequential Organ Failure Assessment score between enrolment and 72 hours. Additional key secondary outcomes include the incidence of renal failure and 30-day mortality.
ETHICS AND DISSEMINATION
The study was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER
The trial is registered on clinicaltrials.gov (NCT03389555). It was posted on 3 January 2018.",2019,The primary end-point for the trial is change in the Sequential Organ Failure Assessment score between enrolment and 72 hours.,['patients with septic shock'],"['ascorbic acid, corticosteroids and thiamine versus placebo', 'Ascorbic Acid, Corticosteroids, and Thiamine', 'ascorbic acid, 100 mg of thiamine and 50 mg of hydrocortisone parenterally versus matching placebo', 'placebo', 'Ascorbic Acid, Corticosteroids and Thiamine', 'ascorbic acid, corticosteroids and thiamine']","['organ injury and mortality', 'Sequential Organ Failure Assessment score', 'incidence of renal failure and 30-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0373727', 'cui_str': 'Vitamin B-1 measurement'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.823062,The primary end-point for the trial is change in the Sequential Organ Failure Assessment score between enrolment and 72 hours.,"[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, United States amoskowi@bidmc.harvard.edu.'}, {'ForeName': 'Tuyen', 'Initials': 'T', 'LastName': 'Yankama', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA, United States.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, MA, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034406']
647,29888938,Hypnotic clever hands: Agency and automatic responding.,"The Clever Hands task (Wegner, Fuller, & Sparrow, 2003) is a behavioral illusion in which participants make responses to a trivia quiz for which they have no sense of agency. Sixty high hypnotizable participants completed two versions of the Clever Hands task. Quiz One was a replication of the original study. Quiz Two was a hypnotic adaptation using three suggestions that were based on clinical disruptions to the sense of agency. The suggestions were for: random responding, thought insertion, and alien control. These suggestions led to differences in accuracy (action production) and estimates of accuracy (action projection). Specifically, whereas the random responding suggestion had little effect, the two clinically based suggestions had opposite impacts on action production: the thought insertion suggestion led to an increase in the rate of correct responses (although participants still believed they were responding randomly); while the alien control suggestion led to a reduction in the rate of correct answers and a pattern of results that more closely approximated randomness. Contrary to theoretical accounts that claim that hypnosis affects executive monitoring rather than executive control, this result indicates that specific hypnotic suggestions can also influence the implicit processes involved in action production. (PsycINFO Database Record",2018,"The Clever Hands task (Wegner, Fuller, & Sparrow, 2003) is a behavioral illusion in which participants make responses to a trivia quiz for which they have no sense of agency.",['Sixty high hypnotizable participants completed two versions of the Clever Hands task'],[],"['accuracy (action production) and estimates of accuracy (action projection', 'rate of correct responses', 'action production']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1279682', 'cui_str': 'Clever (observable entity)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",[],"[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0033363', 'cui_str': 'Projection'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",60.0,0.0326225,"The Clever Hands task (Wegner, Fuller, & Sparrow, 2003) is a behavioral illusion in which participants make responses to a trivia quiz for which they have no sense of agency.","[{'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Polito', 'Affiliation': 'ARC Centre of Excellence in Cognition and its Disorders and Department of Cognitive Science.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Barnier', 'Affiliation': 'ARC Centre of Excellence in Cognition and its Disorders and Department of Cognitive Science.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Connors', 'Affiliation': 'ARC Centre of Excellence in Cognition and its Disorders and Department of Cognitive Science.'}]",Journal of experimental psychology. General,['10.1037/xge0000451']
648,29683700,The importance of therapeutic processes in school-based psychosocial treatment of homework problems in adolescents with ADHD.,"OBJECTIVE
To evaluate the importance of therapeutic processes in two brief school-based psychosocial treatments targeting homework problems in adolescents with attention-deficit/hyperactivity disorder (ADHD) as delivered by school mental health professionals.
METHOD
A sample of 222 middle school students (72% male; M age = 12.00 years, SD = 1.02) diagnosed with ADHD was randomized to receive either a contingency-management or a skills-based treatment for homework problems. Both treatments included 16 individual sessions (20-min each) and 2 parent/family meetings. Adolescents and school mental health professionals reported on the working alliance in the middle of the treatment; professionals rated adolescent involvement at each of the 16 sessions, parent involvement during both parent meetings, and parent commitment to carry out the established homework plan. Attendance at parent meetings was also recorded.
RESULTS
Therapeutic processes predicted objective, parent-reported, and teacher-reported academic outcomes. Parent engagement was particularly important for the contingency-based treatment, whereas working alliance and adolescent involvement were most important for the skills-based treatment.
CONCLUSIONS
Therapeutic processes such as developing a strong working alliance and engaging parents and students are key elements of treatment delivery and receipt in school-based mental health programming and should be explicitly trained and monitored. (PsycINFO Database Record",2018,"Parent engagement was particularly important for the contingency-based treatment, whereas working alliance and adolescent involvement were most important for the skills-based treatment.
","['adolescents with ADHD', 'adolescents with attention-deficit/hyperactivity disorder (ADHD', 'Adolescents and school mental health professionals', '222 middle school students (72% male; M age = 12.00 years, SD = 1.02) diagnosed with ADHD']","['contingency-management or a skills-based treatment for homework problems', 'school-based psychosocial treatments targeting homework problems']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],222.0,0.0332278,"Parent engagement was particularly important for the contingency-based treatment, whereas working alliance and adolescent involvement were most important for the skills-based treatment.
","[{'ForeName': 'Rosanna P', 'Initials': 'RP', 'LastName': 'Breaux', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Langberg', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Bryce D', 'Initials': 'BD', 'LastName': 'McLeod', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Molitor', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Zoe R', 'Initials': 'ZR', 'LastName': 'Smith', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Elizaveta', 'Initials': 'E', 'LastName': 'Bourchtein', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Cathrin D', 'Initials': 'CD', 'LastName': 'Green', 'Affiliation': 'Department of Psychology.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000300']
649,31869005,Between-Individual Differences in Baseline Well-Being and Emotion Regulation Strategy Use Moderate the Effect of a Self-Help Cognitive-Behavioral Intervention for Typical Adults.,"BACKGROUND
Self-help interventions intended to help nonclinical individuals regulate their emotions can have important social benefits (i.e. mental disorder prevention, well-being promotion). However, their mean effect size on well-being is generally low, possibly because there are considerable between-individual differences in the response to these interventions. The present study examined whether individuals' baseline levels of emotional well-being and engagement in emotion regulation strategies moderate the effects on these same variables in a 4-week self-help cognitive-behavioral intervention intended for typical adults.
METHODS
Data were collected from 158 nonclinical French adults (n = 95 for the control group, n = 63 for the cognitive-behavioral group) using experience sampling. Emotional well-being was assessed, as well as the engagement in three emotion regulation strategies (i.e. cognitive reappraisal, problem solving, and appreciation).
RESULTS
As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables. In particular, it was the participants with the most negative baseline levels (i.e. low emotional well-being, low engagement in appreciation) who benefitted most from the intervention.
CONCLUSIONS
Results are discussed in the light of current knowledge on between-individual differences in how individuals respond to interventions.",2020,"As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables.","['Data were collected from 158 nonclinical French adults (n\xa0=\xa095 for the control group, n\xa0=\xa063 for the cognitive-behavioral group) using experience sampling', 'Typical Adults']",['Self-Help Cognitive-Behavioral Intervention'],[],"[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279973', 'cui_str': 'Experience Sampling'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]",[],,0.0158524,"As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables.","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Pavani', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Berna', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andreotti', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Guiller', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Dauvier', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Congard', 'Affiliation': 'Pays de la Loire Psychology Laboratory (LPPL), University of Nantes, Nantes, France.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12189']
650,29703528,"Replication of a Gene-Diet Interaction at CD36, NOS3 and PPARG in Response to Omega-3 Fatty Acid Supplements on Blood Lipids: A Double-Blind Randomized Controlled Trial.","BACKGROUND
Modulation of genetic variants on the effect of omega-3 fatty acid supplements on blood lipids is still unclear.
METHODS
In a double-blind randomized controlled trial, 150 patients with type 2 diabetes (T2D) were randomized into omega-3 fatty acid group (n = 56 for fish oil and 44 for flaxseed oil) and control group (n = 50) for 180 days. All patients were genotyped for genetic variants at CD36 (rs1527483), NOS3 (rs1799983) and PPARG (rs1801282). Linear regression was used to examine the interaction between omega-3 fatty acid intervention and CD36, NOS3 or PPARG variants for blood lipids.
FINDINGS
Significant interaction with omega-3 fatty acid supplements was observed for CD36 on triglycerides (p-interaction = 0.042) and PPAGR on low-density lipoprotein-cholesterol (p-interaction = 0.02). We also found a significant interaction between change in erythrocyte phospholipid omega-3 fatty acid composition and NOS3 genotype on triglycerides (p-interaction = 0.042), total cholesterol (p-interaction = 0.013) and ratio of total cholesterol to high-density lipoprotein cholesterol (p-interaction = 0.015). The T2D patients of CD36-G allele, PPARG-G allele and NOS3-A allele tended to respond better to omega-3 fatty acids in improving lipid profiles. The interaction results of the omega-3 fatty acid group were mainly attributed to the fish oil supplements.
INTERPRETATION
This study suggests that T2D patients with different genotypes at CD36, NOS3 and PPARG respond differentially to intervention of omega-3 supplements in blood lipid profiles.",2018,"FINDINGS
Significant interaction with omega-3 fatty acid supplements was observed for CD36 on triglycerides (p-interaction = 0.042) and PPAGR on low-density lipoprotein-cholesterol (p-interaction = 0.02).","['T2D patients with different genotypes at CD36, NOS3 and PPARG respond differentially to intervention of omega-3 supplements in blood lipid profiles', '150 patients with type 2 diabetes (T2D']","['omega-3 fatty acid supplements', 'omega-3 fatty acid group (n\u202f=\u202f56 for fish oil and 44 for flaxseed oil) and control group', 'Omega-3 Fatty Acid Supplements', 'omega-3 fatty acid']","['CD36 on triglycerides', 'Blood Lipids', 'total cholesterol', 'ratio of total cholesterol to high-density lipoprotein cholesterol', 'low-density lipoprotein-cholesterol', 'erythrocyte phospholipid omega-3 fatty acid composition and NOS3 genotype on triglycerides']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0023754', 'cui_str': 'flaxseed oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]",150.0,0.125763,"FINDINGS
Significant interaction with omega-3 fatty acid supplements was observed for CD36 on triglycerides (p-interaction = 0.042) and PPAGR on low-density lipoprotein-cholesterol (p-interaction = 0.02).","[{'ForeName': 'Ju-Sheng', 'Initials': 'JS', 'LastName': 'Zheng', 'Affiliation': 'Institute of Basic Medical Sciences, Westlake Institute for Advanced Study, Westlake University, Hangzhou 310024, China; Institute of Nutrition and Health, Qingdao University, Qingdao 266071, China; Department of Food Science and Nutrition, Zhejiang University, Hangzhou 310058, China; MRC Epidemiology Unit, University of Cambridge, Cambridge CB20QQ, UK. Electronic address: zhengjusheng@wias.org.cn.'}, {'ForeName': 'Jiewen', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Center for Specialty Strategy Research of Shanghai Jiao Tong University China Hospital Development Institute, Shanghai 200011, China; Department of Clinical Nutrition, Zhejiang Hospital, Hangzhou 310000, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'College of Food Science and Technology, Huazhong Agricultural University, Wuhan 430070, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Wuhan Puai Hospital of Tongji Medical Colledge, Huazhong University of Science and Technology, Wuhan 430034, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ""Second Provincial People's Hospital of Gansu, Lanzhou, 730000, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Changshan People's Hospital, Changshan 324200, China.""}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': ""Department of Endocrinology, Changshan People's Hospital, Changshan 324200, China.""}, {'ForeName': 'Jueping', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Wuhan Puai Hospital of Tongji Medical Colledge, Huazhong University of Science and Technology, Wuhan 430034, China.'}, {'ForeName': 'Kelei', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao 266071, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tang', 'Affiliation': 'Department of Food Science and Nutrition, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Wuhan Puai Hospital of Tongji Medical Colledge, Huazhong University of Science and Technology, Wuhan 430034, China.'}, {'ForeName': 'Chao-Qiang', 'Initials': 'CQ', 'LastName': 'Lai', 'Affiliation': 'USDA Agricultural Research Service, Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'Duo', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Nutrition and Health, Qingdao University, Qingdao 266071, China; Department of Food Science and Nutrition, Zhejiang University, Hangzhou 310058, China. Electronic address: duoli@qdu.edu.cn.'}]",EBioMedicine,['10.1016/j.ebiom.2018.04.012']
651,31552543,"Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical ""Pulse"" Dose.","INTRODUCTION
This small pilot study is the first direct comparison of the currently marketed formulations of bromfenac (0.07% solution) and nepafenac (0.3% suspension) using identical dosing regimens and including an extra pre-surgical ""pulse"" dose in patients undergoing cataract surgery.
METHODS
Adults scheduled for unilateral phacoemulsification with intraocular lens implantation were randomly assigned to bromfenac 0.07% or nepafenac 0.3%, each given once-daily 1 day prior to surgery, on the day of surgery plus an extra dose 1 h before surgery, and for 14 days after surgery. Assessments included summed ocular inflammation score (SOIS), visual acuity (VA), and retinal thickness measured via optical coherence tomography.
RESULTS
The study population included 49 patients (bromfenac, n = 24; nepafenac, n = 25). The percentage of patients with a SOIS = 0 (no cells or flare) at post-surgical day 15 (primary efficacy endpoint) was statistically similar between the bromfenac (57.1%) and nepafenac (50.0%) treatment groups (intent-to-treat with last observation carried forward) (P = 0.6318). The proportions of patients with an SOIS of 0 at days 3 and 8 were significantly (P < 0.05) higher in the bromfenac group (23.8 and 52.4%, respectively) versus the nepafenac group (0.0 and 20.8%, respectively). Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness. Rescue medication (typically difluprednate) was given on or before day 15 to 13 patients in each treatment group (bromfenac, 54.2%; nepafenac, 52.0%). There were no adverse events considered to be related to either treatment.
CONCLUSIONS
The results of this small pilot study suggest that once-daily bromfenac 0.07% produces similar benefits with regard to postsurgical inflammation, VA, and retinal thickness as once-daily nepafenac 0.3%, and possibly has a faster onset of anti-inflammatory action, when compared using identical dosing regimens.
FUNDING
Bausch & Lomb Incorporated.
TRIAL REGISTRATION
NCT03886779.",2019,"Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness.","['49 patients (bromfenac, n\u2009=\u200924; nepafenac, n\u2009=\u200925', 'Adults scheduled for unilateral phacoemulsification with intraocular lens implantation', 'patients undergoing cataract surgery', 'Post-Cataract Surgery Inflammation']","['Nepafenac Ophthalmic Suspension', 'nepafenac', 'nepafenac (0.3% suspension']","['Visual acuity', 'summed ocular inflammation score (SOIS), visual acuity (VA), and retinal thickness measured via optical coherence tomography']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0054094', 'cui_str': 'bromfenac'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1276060', 'cui_str': 'Phacoemulsification of lens and insertion of prosthetic replacement (procedure)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C3530973', 'cui_str': 'nepafenac Ophthalmic Suspension [Ilevro]'}, {'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}]",49.0,0.10952,"Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness.","[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'Silverstein Eye Centers, Kansas City, MO, USA. ssilverstein@silversteineyecenters.com.'}]",Ophthalmology and therapy,['10.1007/s40123-019-00215-y']
652,31725692,Impact of Preoperative Acetaminophen and Carbohydrate Loading on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Nonmelanoma Skin Cancers.,"BACKGROUND
Preoperative acetaminophen and carbohydrate loading has been shown to improve the functional recovery of surgical patients.
OBJECTIVE
To determine the effects of preoperative acetaminophen and carbohydrates on functional outcomes and the use of pain medications after surgery in patients undergoing Mohs Micrographic Surgery (MMS) for nonmelanoma skin cancer (NMSC).
MATERIALS AND METHODS
One hundred patients treated with MMS for NMSC at an academic center were randomized into a control group receiving standard preoperative care or an intervention group receiving acetaminophen and carbohydrate drinks immediately before surgery. Patients rated levels of pain, thirst, hunger, anxiety, and fatigue on the day of surgery on a scale of 0 to 100, and reported through a phone interview the use of pain medications within 48 hours of surgery.
RESULTS
There was no significant difference between intervention and control groups in maximum pain score on the day of surgery; maximum pain score 48 hours after surgery; use of nonopioid pain medications; and use of opioids. However, the intervention group had lower anxiety levels during and at the end of surgery.
CONCLUSION
Patients undergoing MMS for NMSC reported very low levels of pain during and after surgery. Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.",2020,Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.,"['patients undergoing Mohs Micrographic Surgery (MMS) for nonmelanoma skin cancer (NMSC', 'One hundred patients treated with MMS for NMSC at an academic center', 'Patients Undergoing Mohs Micrographic Surgery for Nonmelanoma Skin Cancers']","['Preoperative Acetaminophen and Carbohydrate Loading', 'preoperative acetaminophen and carbohydrates', 'control group receiving standard preoperative care or an intervention group receiving acetaminophen and carbohydrate drinks immediately before surgery', 'acetaminophen and carbohydrate loading', 'Preoperative acetaminophen and carbohydrate loading']","['levels of pain, thirst, hunger, anxiety, and fatigue', 'lower anxiety levels', 'maximum pain score', 'pain levels', 'Pain and Functional Status', 'levels of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4277655', 'cui_str': 'Diet, Carbohydrate Loading'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033061', 'cui_str': 'Preoperative Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",100.0,0.0310906,Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Aleisa', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Naccarato', 'Affiliation': 'Department of Dermatology, Tufts School of Medicine, Department of Dermatology, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Gramz', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jalak', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Bichchau', 'Initials': 'B', 'LastName': 'Nguyen', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002161']
653,30859218,One-year safety and efficacy of intravenous etelcalcetide in patients on hemodialysis with secondary hyperparathyroidism.,"BACKGROUND
Secondary hyperparathyroidism (sHPT), a common complication of chronic kidney disease, is characterized by elevated serum parathyroid hormone (PTH). Etelcalcetide is an intravenous calcimimetic that increases sensitivity of the calcium-sensing receptor to calcium and decreases PTH secretion. This open-label extension (OLE) trial evaluated the long-term effects of etelcalcetide for sHPT treatment in patients receiving hemodialysis.
METHODS
This 52-week, multicenter, single-arm OLE enrolled patients from three parent trials: two randomized, double-blind, placebo-controlled trials and one open-label, single-arm, 'switch' study from cinacalcet to etelcalcetide. The primary endpoint was to investigate the nature, frequency, severity and relation to treatment of all adverse events (AEs) reported throughout the trial. Secondary endpoints included the proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product (Ca × P).ClinicalTrials.gov identifier: NCT01785875; Amgen study: 20120231.
RESULTS
Overall, 89.8% of the patients experienced one or more treatment-emergent AE. The most common were decreased blood Ca (43.3%), diarrhea (10.8%), vomiting (10.4%) and nausea (9.6%); symptomatic hypocalcemia occurred in 3.7% of the patients. Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
CONCLUSIONS
Etelcalcetide effectively lowered PTH and its effect was sustained, while no new safety concerns emerged over a 1-year treatment period.",2020,"Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
","['patients on hemodialysis with secondary hyperparathyroidism', 'patients receiving hemodialysis']","['intravenous etelcalcetide', 'etelcalcetide', 'placebo']","['vomiting', 'proportion of patients with >30% reduction from baseline in PTH and the percentage change from baseline in PTH, albumin-corrected calcium (Ca), phosphate (P) and the calcium-phosphate product', 'symptomatic hypocalcemia', 'blood', 'nature, frequency, severity and relation to treatment of all adverse events (AEs', 'Ca', 'diarrhea', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0020503', 'cui_str': 'Hyperparathyroidism, Secondary'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3713906', 'cui_str': 'velcalcetide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C2732404', 'cui_str': 'Corrected measurement of calcium (procedure)'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0005768'}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.188422,"Approximately 68% of patients achieved >30% reduction in PTH, and ∼56% achieved PTH ≤300 pg/mL. Mean percent changes from baseline ranged from -25.4% to -26.1% for PTH, -8.3% to -9.1% for Ca, -3.6% to -4.1% for P and -12.0% to -12.6% for Ca × P.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bushinsky', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Rochester School of Medicine, Rochester, NY, USA.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Department of Medicine, Division of Nephrology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Clinical Development, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Biostatistics, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Kopyt', 'Affiliation': 'Department of Medicine, Division of Nephrology, Lehigh Valley Hospital, Allentown, PA, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Martin', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, Saint Louis University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ureña-Torres', 'Affiliation': 'Department of Nephrology and Dialysis, Ramsay-Générale de Santé, Clinique du Landy, Saint Ouen, France and Necker Hospital, University of Paris Descartes, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Denver Nephrology, Denver, CO, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz039']
654,31678965,Effects of self-monitoring devices on blood pressure in older adults with hypertension and diabetes: a randomised controlled trial.,"BACKGROUND
Hypertension and diabetes frequently coexist, which results in the difficulty of hypertension control in community-dwelling elderly adults who lack effective prevention and control strategies. The aim of this study is to determine whether a combined pedometer and home blood pressure monitoring (HBPM) programme could improve blood pressure (BP) among community-dwelling elderly adults with hypertension and diabetes.
METHODS
The trial was a 2×2 factorial randomised clinical trial that recruited 180 community-dwelling elderly people (aged ≥60) with hypertension and diabetes in Tianjin, China. Participants were randomly assigned to control, pedometer, HBPM, and pedometer+HBPM groups. Intervention period was 12 months. The coprimary outcomes of the study were systolic and diastolic BP; the secondary outcomes included the proportion of patients with controlled hypertension. BP was measured twice in the right arm using a mercurial sphygmomanometer. The mean of these two measurements was taken as the BP value.
RESULTS
At 12 months, compared with the control group, the adjusted differences in least squares mean (95% CI) in systolic and diastolic BP changes for pedometer, HBPM, and pedometer+HBPM groups were -4.2 (-8.4 to 0.1), -2.7 (-6.9 to 1.5) and -8.1 (-12.3 to -3.9) mm Hg (p<0.01); -3.2 (-5.2 to -1.1), -0.1(-2.1 to 1.9) and -3.6 (-5.6 to -1.5) mm Hg (p<0.001), respectively; the adjusted difference in percentage (95% CI) in the controlled hypertension (BP <140/90 mm Hg) for pedometer, HBPM and pedometer+HBPM groups were 7.5 (-12.2 to 27.1), 9.9 (-10.4 to 30.3) and 23.1 (5.0 to 41.1) (p=0.09).
CONCLUSION
Combination pedometer and HBPM interventions can significantly decrease BP levels in elderly adults with hypertension and diabetes.
TRIALS REGISTRATION NUMBER
UMIN000021613.",2020,"At 12 months, compared with the control group, the adjusted differences in least squares mean (95% CI) in systolic and diastolic BP changes for pedometer, HBPM, and pedometer+HBPM groups were -4.2 (-8.4 to 0.1), -2.7","['elderly adults with hypertension and diabetes', '180 community-dwelling elderly people (aged ≥60) with hypertension and diabetes in Tianjin, China', 'older adults with hypertension and diabetes', 'community-dwelling elderly adults with hypertension and diabetes', 'community-dwelling elderly adults']","['self-monitoring devices', 'combined pedometer and home blood pressure monitoring (HBPM) programme', 'Combination pedometer and HBPM interventions']","['BP levels', 'blood pressure', 'systolic and diastolic BP', 'blood pressure (BP', 'BP', 'systolic and diastolic BP changes', 'proportion of patients with controlled hypertension']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1449681', 'cui_str': 'Blood Pressure Monitoring, Home'}, {'cui': 'C0649948', 'cui_str': 'HBPM'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]",180.0,0.0699171,"At 12 months, compared with the control group, the adjusted differences in least squares mean (95% CI) in systolic and diastolic BP changes for pedometer, HBPM, and pedometer+HBPM groups were -4.2 (-8.4 to 0.1), -2.7","[{'ForeName': 'Yeqing', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Bao', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Meng', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Health Management Centre, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Health Management Centre, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Health Management Centre, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yaogang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Kaijun', 'Initials': 'K', 'LastName': 'Niu', 'Affiliation': 'Nutritional Epidemiology Institute and School of Public Health, Tianjin Medical University, Tianjin, China nkj0809@gmail.com.'}]",Journal of epidemiology and community health,['10.1136/jech-2019-212531']
655,31713753,Transcranial direct current stimulation improves the swallowing function in patients with cricopharyngeal muscle dysfunction following a brainstem stroke.,"OBJECTIVE
This study investigated the effects of transcranial direct current stimulation (tDCS) combined with conventional swallowing training on the swallowing function in brainstem stroke patients with cricopharyngeal muscle dysfunction (CPD).
METHODS
Twenty-eight brainstem stroke patients with CPD were assigned randomly to an anodal tDCS group or a sham tDCS group. The patients received anodal tDCS or sham tDCS over the bilateral oesophageal cortical area combined with simultaneous catheter balloon dilatation and conventional swallowing therapy for 20 days. Swallowing function was assessed using the functional oral intake scale (FOIS) and the functional dysphagia scale (FDS) and by measuring the pharyngoesophageal Segment Opening (PESO) before and immediately after the intervention.
RESULTS
Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005). However, compared with the sham stimulation group, the anodal tDCS group showed greater improvements in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).
CONCLUSION
The bihemispheric anodal tDCS combined with simultaneous catheter balloon dilatation and conventional swallowing therapy effectively improves the swallowing function in patients with CPD caused by a brainstem stroke. tDCS may be an effective adjuvant therapy in CPD rehabilitation.",2020,"Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).","['brainstem stroke patients with cricopharyngeal muscle dysfunction (CPD', 'patients with CPD caused by a brainstem stroke', 'Twenty-eight brainstem stroke patients with CPD', 'patients with cricopharyngeal muscle dysfunction following a brainstem stroke']","['bihemispheric anodal tDCS combined with simultaneous catheter balloon dilatation and conventional swallowing therapy', 'tDCS', 'anodal tDCS', 'anodal tDCS or sham tDCS', 'Transcranial direct current stimulation', 'bilateral oesophageal cortical area combined with simultaneous catheter balloon dilatation and conventional swallowing therapy', 'anodal tDCS group or a sham tDCS', 'transcranial direct current stimulation (tDCS) combined with conventional swallowing training']","['FDS, FOIS and PESO scores', 'swallowing function', 'Swallowing function', 'functional oral intake scale (FOIS) and the functional dysphagia scale (FDS) and by measuring the pharyngoesophageal Segment Opening (PESO']","[{'cui': 'C0521542', 'cui_str': 'Brainstem Stroke'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0222045'}, {'cui': 'C4302242', 'cui_str': 'Functional dysphagia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",,0.0176615,"Both groups showed a significant improvement in the FDS, FOIS and PESO scores immediately after the intervention (all p < .005).","[{'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China.'}, {'ForeName': 'Zheng-Kun', 'Initials': 'ZK', 'LastName': 'Lin', 'Affiliation': 'Department of Rehabilitation Medicine, The 909th Hospital, 269 Zhanghua Middle Road, Zhangzhou, 363000, China.'}, {'ForeName': 'Guo-Xin', 'Initials': 'GX', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Fujian Medical University, 20 Chazhong Road, Fuzhou, 350005, China. guoxinni@fjmu.edu.cn.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04120-x']
656,30895459,Suspension syndrome: a potentially fatal vagally mediated circulatory collapse-an experimental randomized crossover trial.,"PURPOSE
Suspension syndrome describes a potentially life-threatening event during passive suspension on a rope. The pathophysiological mechanism is not fully understood and optimal treatment unknown. We aimed to elucidate the pathophysiology and to give treatment recommendations.
METHODS
In this experimental, randomized crossover trial, 20 healthy volunteers were suspended in a sit harness for a maximum of 60 min, with and without prior climbing. Venous pooling was assessed by measuring the diameter of the superficial femoral vein (SFV), lower leg tissue oxygenation (StO 2 ) and by determining localized bioelectrical impedance. Hemodynamic response was assessed by measuring heart rate, blood pressure, stroke volume, and left ventricular diameters. Signs and symptoms of pre-syncope were recorded.
RESULTS
Twelve (30%) out of 40 tests were prematurely terminated due to pre-syncopal symptoms (mean 44.7 min, minimum 13.4, maximum 59.7). SFV diameter increased, StO 2 and the capacitive resistance of the cells decreased indicating venous pooling. Heart rate and blood pressure did not change in participants without pre-syncope. In contrast, in participants experiencing pre-syncope, heart rate and blood pressure dropped immediately before the event. All symptoms dissolved and values returned to normal within 5 min with participants in a supine position.
CONCLUSIONS
Sudden pre-syncope during passive suspension in a harness was observed in 30% of the tests. Blood pools in the veins of the lower legs; however, a vagal mechanism finally leads to loss of consciousness. Time to pre-syncope is unpredictable and persons suspended on a rope should be rescued and put into a supine position as soon as possible.",2019,Heart rate and blood pressure did not change in participants without pre-syncope.,"['20 healthy volunteers', 'participants without pre-syncope']",[],"['pre-syncope, heart rate and blood pressure', 'SFV diameter increased, StO 2 and the capacitive resistance of the cells decreased indicating venous pooling', 'Heart rate and blood pressure', 'Hemodynamic response', 'pre-syncopal symptoms', 'Signs and symptoms of pre-syncope', 'diameter of the superficial femoral vein (SFV), lower leg tissue oxygenation (StO 2 ', 'heart rate, blood pressure, stroke volume, and left ventricular diameters']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0700200', 'cui_str': 'Presyncope'}]",[],"[{'cui': 'C0700200', 'cui_str': 'Presyncope'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0015809', 'cui_str': 'Femoral vein structure'}, {'cui': 'C1140621', 'cui_str': 'Leg'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}]",20.0,0.058059,Heart rate and blood pressure did not change in participants without pre-syncope.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rauch', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy. simon.rauch@eurac.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schenk', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Strapazzon', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dal Cappello', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Palma', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Erckert', 'Affiliation': 'Department of Cardiology, F. Tappeiner Hospital, 39012, Merano, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Oberhuber', 'Affiliation': 'Department of Internal Medicine I, Gastroenterology, Hepatology, Metabolism and Endocrinology, Medical University Innsbruck, 6020, Innsbruck, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bliemsrieder', 'Affiliation': 'Department of Anesthesiology, Garmisch-Partenkirchen Medical Center, 82467, Garmisch-Partenkirchen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brugger', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Paal', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Brothers of St. John of God Hospital, Paracelsus Medical University, Kajetanerplatz 1, 5010, Salzburg, Austria.'}]",European journal of applied physiology,['10.1007/s00421-019-04126-5']
657,30982680,"Sacubitril/valsartan in heart failure with reduced ejection fraction patients: Real world experience on advanced chronic kidney disease, hypotension, and dose escalation.","BACKGROUND
Angiotensin receptor and neprilysin inhibition (ARNI) has been shown to reduce cardiovascular mortality by 20% as compared with enalapril in a randomized controlled trial. However, there is a paucity of real-world data on the effects of ARNI in heart failure patients with reduced ejection fraction (HFrEF), especially those with concurrent renal impairment or hypotension.
METHODS
Between 2016 and 2017, we recruited 466 HFrEF patients treated with sacubitril/valsartan (Group A) and 466 patients managed with standard HF treatment without ARNI (Group B) in a HF referral center. Baseline characteristics and clinical outcomes were collected between both groups.
RESULTS
Baseline characteristics were comparable between the two groups. During a follow-up period of 15 months, death from cardiovascular causes or first unplanned hospitalization for HF occurred in 100 patients in Group A (21.5%) and 144 in Group B (30.9%, hazard ratio 0.66; 95% CI 0.51-0.85; p=0.001). The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients. Among patients with different chronic kidney disease stages and normotensive patients, treatment with sacubitril/valsartan showed more favorable outcomes than treatment with standard HF care without ARNI. However, in patients with baseline systolic blood pressure lower than 100mmHg, there were no significant differences of outcomes in both groups. Among Group A patients, escalation of sacubitril/valsartan was associated with better outcomes.
CONCLUSIONS
Our study demonstrated the effectiveness of sacubitril/valsartan on HFrEF patients in real world practice, including those with advanced renal impairment.",2019,"The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients.","['heart failure patients with reduced ejection fraction (HFrEF), especially those with concurrent renal impairment or hypotension', 'Group A) and 466 patients managed with', 'heart failure with reduced ejection fraction patients', '466 HFrEF patients treated with', 'Between 2016 and 2017', 'HFrEF patients in real world practice, including those with advanced renal impairment', 'patients with different chronic kidney disease stages and normotensive patients']","['standard HF treatment without ARNI', 'enalapril', 'Sacubitril/valsartan', 'sacubitril/valsartan', 'Angiotensin receptor and neprilysin inhibition (ARNI']","['baseline systolic blood pressure', 'death from cardiovascular causes or first unplanned hospitalization for HF', 'cardiovascular mortality', 'incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor (substance)'}, {'cui': 'C0025250', 'cui_str': 'CALLA Antigen'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}]",466.0,0.062689,"The incidences of deaths from any causes, cardiovascular death, sudden death, and HF re-hospitalization were all significantly lower in Group A than Group B patients.","[{'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Chang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'An-Ning', 'Initials': 'AN', 'LastName': 'Feng', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Man-Cai', 'Initials': 'MC', 'LastName': 'Fong', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chao-Wen', 'Initials': 'CW', 'LastName': 'Hsueh', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Tsung', 'Initials': 'WT', 'LastName': 'Lai', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Chih', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, Farrer Park Hospital, Singapore.'}, {'ForeName': 'Chi-Nan', 'Initials': 'CN', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hung-Chuan', 'Initials': 'HC', 'LastName': 'Chang', 'Affiliation': 'Department of Pharmacy, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Hsian', 'Initials': 'WH', 'LastName': 'Yin', 'Affiliation': 'Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: adr@chgh.org.tw.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.03.010']
658,31713266,"Innovative 1064-nm Nd:YAG Laser Significantly Improves Keratosis Pilaris, A Randomized, Double-Blind, Sham-Irradiation-Controlled Trial.","BACKGROUND AND OBJECTIVE
Keratosis pilaris (KP) is a common follicular disorder for which various topical agents and energy-based devices have been used with some efficacy. To evaluate the efficacy of a novel 1064-nm Nd:YAG laser for the reduction of skin roughness, erythema, and hyperpigmentation in KP subjects.
STUDY DESIGN/MATERIALS AND METHODS
Twenty-three subjects with untreated KP on the upper outer arms participated in a randomized, single-blind fashion. One arm of each subject was divided into upper and lower parts. One part was randomized to be treated with an innovative 1064-nm Nd:YAG laser, while the other part received sham irradiation. Subjects received four consecutive treatments at 4-week intervals. Antera3D was used to measure skin roughness, erythema, and hyperpigmentation at baseline and 4 weeks after the last treatment. Moreover, clinical outcomes were also evaluated by subjects' Global Improvement Score (GIS) and subjects' satisfaction grading scores.
RESULTS
Twenty-three subjects completed the study. There was statistically significant reduction of skin roughness measured by Antera3D compared with control group (P < 0.001). There were statistically significant improvements of skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score (P < 0.001 all). Subjects' satisfaction scores were graded significantly better in treatment parts (P < 0.001). No adverse events including burning, bulla, erosion, post-inflammatory hyper/hypopigmentation, and scar formation developed in any subjects throughout the study period.
CONCLUSION
This innovative 1064-nm Nd:YAG laser has proved to significantly and safely reduce skin roughness in Thai KP subjects compared with control after four sessions. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2020,"There were statistically significant improvements of skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score (P < 0.001 all).","['Keratosis pilaris (KP', 'Twenty-three subjects with untreated KP on the upper outer arms participated', '2019', 'Thai KP subjects', 'Twenty-three subjects completed the study']","['innovative 1064-nm Nd:YAG laser, while the other part received sham irradiation', 'novel 1064-nm Nd:YAG laser', 'Innovative 1064-nm Nd:YAG Laser']","[""skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score"", 'skin roughness, erythema, and hyperpigmentation', 'adverse events including burning, bulla, erosion, post-inflammatory hyper/hypopigmentation, and scar formation', ""Subjects' satisfaction scores"", ""subjects' Global Improvement Score (GIS) and subjects' satisfaction grading scores"", 'skin roughness']","[{'cui': 'C0870082', 'cui_str': 'Hyperkeratosis of skin'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0162834', 'cui_str': 'Hypermelanosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005758', 'cui_str': 'Vesication'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0162835', 'cui_str': 'Hypomelanosis'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",23.0,0.0402668,"There were statistically significant improvements of skin roughness, erythema, hyperpigmentation, and overall appearances graded by subjects' Global Improvement Score (P < 0.001 all).","[{'ForeName': 'Praewvanid', 'Initials': 'P', 'LastName': 'Maitriwong', 'Affiliation': 'Department of Medicine, Division of Dermatology, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Natsinee', 'Initials': 'N', 'LastName': 'Tangkijngamvong', 'Affiliation': 'Department of Medicine, Division of Dermatology, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Department of Medicine, Division of Dermatology, Faculty of Medicine, Chulalongkorn University, 1873 Rama 4 Road, Bangkok, 10330, Thailand.'}]",Lasers in surgery and medicine,['10.1002/lsm.23184']
659,31816096,Endoscopic Versus Microscopic Management of Attic Cholesteatoma: A Randomized Controlled Trial.,"OBJECTIVES
To compare endoscopic transcanal approach to attic cholesteatoma with conventional microscopic transcanal technique METHODS: Seventy-eight patients diagnosed with attic cholesteatoma were randomly assigned into two groups-one undergoing endoscopic approach and the other microscopic technique. The two groups were compared in terms of area of exposure, access to hidden areas in terms of Middle Ear Structural Visibility Index (MESVI), intraoperative time, postoperative pain, vertigo, long-term hearing, and surgical outcomes.
RESULTS
The mean area of exposure in endoscopic atticotomy required was less than that in microscopic group and was found to be statistically significant. The median MESVI for endoscopic group better than that for microscopic group (P < .0001). The mean operating time in endoscopic approach was less than that in case of microscopic approach, with P < .05. The median postoperative pain score in the endoscopic group was less than that in microscopic group (P < .05). No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure. When long-term surgical outcomes were assessed at 1 year, in endoscopic group, one patient had disease recurrence, one cartilage displacement, one perforation, and two had retraction pocket formation. In the microscopic group, two patients had recurrence, four cartilage displacement, one perforation, and five retraction pocket formation.
CONCLUSION
Endoscopic management of limited attic cholesteatoma has definite advantages over the conventional microscopic approach.
LEVEL OF EVIDENCE
1 Laryngoscope, 130:2461-2466, 2020.",2020,No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure.,"['Attic Cholesteatoma', ' Seventy-eight patients diagnosed with attic cholesteatoma']","['endoscopic approach and the other microscopic technique', 'endoscopic transcanal approach to attic cholesteatoma with conventional microscopic transcanal technique']","['vertigo', 'disease recurrence, one cartilage displacement, one perforation, and two had retraction pocket formation', 'median MESVI', 'mean area of exposure in endoscopic atticotomy', 'Middle Ear Structural Visibility Index (MESVI), intraoperative time, postoperative pain, vertigo, long-term hearing, and surgical outcomes', 'median postoperative pain score', 'mean operating time in endoscopic approach']","[{'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0563050', 'cui_str': 'Attic (environment)'}, {'cui': 'C0008373', 'cui_str': 'Cholesteatoma'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0241518', 'cui_str': 'Retraction of tympanic membrane (finding)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0198106', 'cui_str': 'Atticotomy of ear (procedure)'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure (body structure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",78.0,0.0610664,No significant difference was found between two groups in terms of vertigo experienced at the end of first week and air-bone gap closure.,"[{'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Sandipta', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Ghosh', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Arunabha', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}]",The Laryngoscope,['10.1002/lary.28446']
660,31816103,Using stakeholder perspectives to guide systematic adaptation of an autism mental health intervention for Latinx families: A qualitative study.,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families. Recommendations were collected through focus groups with therapists (n = 17) and semi-structured interviews with Latinx parents (n = 29). Relevant themes were identified through a rapid assessment analysis process and thematic coding of interviews. Adaptations were classified according to the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME) to facilitate fit, acceptability, and sustained implementation of AIM HI and classify the content, nature, and goals of the adaptations. Recommended adaptations were classified through FRAME as tailoring training and intervention materials, changing packaging or materials, extending intervention pacing, and integrating supplemental training strategies. Goals for adaptations included improving fit for stakeholders, increasing parent engagement, and enhancing intervention effectiveness. The current study illustrates the process of embedding an iterative process of intervention adaptation within a hybrid effectiveness-implementation trial. The next steps in this study are to integrate findings with implementation process data from the parent trial to develop a cultural enhancement to AIM HI and test the enhancement in a Hybrid Type 3 implementation-effectiveness trial.",2020,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families.","['publicly funded mental health services', 'autism mental health intervention for Latinx families']",['Individualized Mental Health Intervention'],[],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],,0.0324744,"Embedded within a Hybrid Type 1 randomized effectiveness-implementation trial in publicly funded mental health services, the current study identified stakeholder recommendations to inform cultural adaptations to An Individualized Mental Health Intervention for Autism Spectrum Disorder (AIM HI) for Latinx and Spanish-speaking families.","[{'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Hurwich-Reiss', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}, {'ForeName': 'Blanche', 'Initials': 'B', 'LastName': 'Wright', 'Affiliation': 'Department of Psychology, University of California Los Angeles, Los Angeles, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California.'}]",Journal of community psychology,['10.1002/jcop.22296']
661,30794093,The Effectiveness of Driving Game on Trunk Control and Gait Ability in Stroke.,"Patients who require neurological rehabilitation often do not comply with conventional programs because they find the therapy uninteresting. As a result, specialized interactive video games have been designed to be more enjoyable than conventional therapy (CT) tasks. This study aimed to assess the trunk control and gait ability of patients with chronic stroke after participation in driving-based interactive video games (DBIVG). Participants included 24 chronic stroke patients allocated to an experimental group ( n = 13, CT + DBIVG) or a control group ( n = 11, CT + treadmill walking training). Both groups received CT five days/week; the experimental and control groups participated in DBIVG and treadmill walking training, respectively, three days/week for four weeks. The primary outcome of trunk control was measured by the trunk impairment scale (TISall) and TIS subscales, including static sitting balance (TISssb), dynamic sitting balance (TISdsb), and trunk co-ordination (TISco). Gait ability was measured by the dynamic gait index (DGI), timed walking test (TWT), and time up and go test (TUGT). Both groups demonstrated significant improvements in TISall, TISdsb, and TUGT results. The experimental group showed significantly greater improvement in TISssb, TISco, and DGI than the control group. Our findings indicate that DBIVG can improve trunk control and gait ability in patients with chronic stroke.",2020,"The experimental group showed significantly greater improvement in TISssb, TISco, and DGI than the control group.","['patients with chronic stroke', 'patients with chronic stroke after participation in driving-based interactive video games (DBIVG', 'Stroke', 'Patients who require neurological rehabilitation often do not comply with conventional programs because they find the therapy uninteresting', 'Participants included 24 chronic stroke patients']","['DBIVG', 'DBIVG and treadmill walking training', 'experimental group (n\u2009=\u200913, CT\u2009+\u2009DBIVG', 'Driving Game', 'control group (n\u2009=\u200911, CT\u2009+\u2009treadmill walking training']","['trunk impairment scale (TISall) and TIS subscales, including static sitting balance (TISssb), dynamic sitting balance (TISdsb), and trunk co-ordination (TISco', 'trunk control', 'trunk control and gait ability', 'dynamic gait index (DGI), timed walking test (TWT), and time up and go test (TUGT', 'TISall, TISdsb, and TUGT results', 'Gait ability', 'TISssb, TISco, and DGI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0426971', 'cui_str': 'Trunk control (observable entity)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2919794', 'cui_str': 'Dynamic gait index (assessment scale)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",24.0,0.0120447,"The experimental group showed significantly greater improvement in TISssb, TISco, and DGI than the control group.","[{'ForeName': 'Daegyun', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Graduate School, Gachon University, Incheon, Republic of Korea.'}, {'ForeName': 'Youngsook', 'Initials': 'Y', 'LastName': 'Bae', 'Affiliation': 'Department of Physical Therapy, Graduate School, Gachon University, Incheon, Republic of Korea.'}]",Journal of motor behavior,['10.1080/00222895.2019.1574259']
662,30985861,Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations.,"Importance
The United States spends more than $12 billion annually on graduate medical education. Understanding how residents balance patient care and educational activities may provide insights into how the modern physician workforce is being trained.
Objective
To describe how first-year internal medicine residents (interns) allocate time while working on general medicine inpatient services.
Design, Setting, and Participants
Direct observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region, of the Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, a cluster-randomized trial comparing different duty-hour policies. A total of 194 weekday shifts were observed and time motion data were collected, sampled by daytime, nighttime, and call shifts in proportion to the distribution of shifts within each program from March 10 through May 31, 2016. Data were analyzed from June 1, 2016, through January 5, 2019.
Main Outcomes and Measures
Mean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night). Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care were tracked.
Results
A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours. A mean (SD) of 15.9 (0.7) hours of a 24-hour period (66%) was spent in indirect patient care, mostly interactions with the patient's medical record or documentation (mean [SD], 10.3 [0.7] hours; 43%). A mean (SD) of 3.0 (0.1) hours was spent in direct patient care (13%) and 1.8 (0.3) hours in education (7%). This pattern was consistent across the 4 periods of the day. Direct patient care and education frequently occurred when interns were performing indirect patient care. Multitasking with 2 or more indirect patient care activities occurred for a mean (SD) of 3.8 (0.4) hours (16%) of the day.
Conclusions and Relevance
This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities. These findings provide an essential baseline measure for future efforts designed to improve the workday structure and experience of internal medicine trainees, without making a judgment on the current allocation of time.
Trial Registration
ClinicalTrials.gov identifier: NCT02274818.",2019,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","['Participants\n\n\nDirect observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region', 'A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours']",[],"['indirect patient care activities', 'time motion data', 'Measures\n\n\nMean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night', 'Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care']","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026053', 'cui_str': 'Middle Atlantic States'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]",[],"[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0017313'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]",,0.0475539,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","[{'ForeName': 'Krisda H', 'Initials': 'KH', 'LastName': 'Chaiyachati', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Manqing', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bellini', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'C Jessica', 'Initials': 'CJ', 'LastName': 'Dine', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Yevgeniy', 'Initials': 'Y', 'LastName': 'Gitelman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Yeager', 'Affiliation': 'Department of Medicine, Yale-New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Asch', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sanjay V', 'Initials': 'SV', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0095']
663,29488628,Effect of prenatal mindfulness training on depressive symptom severity through 18-months postpartum: A latent profile analysis.,"OBJECTIVE
We examined whether prenatal mindfulness training was associated with lower depressive symptoms through 18-months postpartum compared to treatment as usual (TAU).
METHOD
A controlled, quasi-experimental trial compared prenatal mindfulness training (MMT) to TAU. We collected depressive symptom data at post-intervention, 6-, and 18-months postpartum. Latent profile analysis identified depressive symptom profiles, and multinomial logistic regression examined whether treatment condition predicted profile.
RESULTS
Three depressive symptom severity profiles emerged: none/minimal, mild, and moderate. Adjusting for relevant covariates, MMT participants were less likely than TAU participants to be in the moderate profile than the none/minimal profile (OR = 0.13, 95% CI = 0.03-0.54, p = .005).
CONCLUSIONS
Prenatal mindfulness training may have benefits for depressive symptoms during the transition to parenthood.",2018,"OBJECTIVE
We examined whether prenatal mindfulness training was associated with lower depressive symptoms through 18-months postpartum compared to treatment as usual (TAU).
",['through 18-months postpartum'],"['Prenatal mindfulness training', 'prenatal mindfulness training (MMT) to TAU', 'prenatal mindfulness training']","['depressive symptoms', 'depressive symptom severity']","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0317104,"OBJECTIVE
We examined whether prenatal mindfulness training was associated with lower depressive symptoms through 18-months postpartum compared to treatment as usual (TAU).
","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Felder', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Roubinov', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco.'}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Bush', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Coleman-Phox', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, San Francisco.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Vieten', 'Affiliation': 'Institute of Noetic Sciences and California Pacific Medical Center Research Institute.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Laraia', 'Affiliation': 'Community Health Sciences, University of California, Berkeley.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco.'}]",Journal of clinical psychology,['10.1002/jclp.22592']
664,30864532,Home treatment for acute mental healthcare: randomised controlled trial.,"BACKGROUND
Home treatment has been proposed as an alternative to acute in-patient care for mentally ill patients. However, there is only moderate evidence in support of home treatment.
AIMS
To test whether and to what degree home treatment services would enable a reduction (substitution) of hospital use.
METHOD
A total of 707 consecutively admitted adult patients with a broad spectrum of mental disorders (ICD-10: F2-F6, F8-F9, Z) experiencing crises that necessitated immediate admission to hospital, were randomly allocated to either a service model including a home treatment alternative to hospital care (experimental group) or a conventional service model that lacked a home treatment alternative to in-patient care (control group) (trial registration at ClinicalTrials.gov: NCT02322437).
RESULTS
The mean number of hospital days per patient within 24 months after the index crisis necessitating hospital admission (primary outcome) was reduced by 30.4% (mean 41.3 v. 59.3, P<0.001) when a home treatment team was available (intention-to-treat analysis). Regarding secondary outcomes, average overall treatment duration (hospital days + home treatment days) per patient (mean 50.4 v. 59.3, P = 0.969) and mean number of hospital admissions per patient (mean 1.86 v. 1.93, P = 0.885) did not differ statistically significantly between the experimental and control groups within 24 months after the index crisis. There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242).
CONCLUSIONS
Home treatment services can reduce hospital use among severely ill patients in acute crises and seem to result in comparable clinical/social outcomes and patient satisfaction as standard in-patient care.",2020,"There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242).
","['707 consecutively admitted adult patients with a broad spectrum of mental disorders (ICD-10: F2-F6, F8-F9, Z) experiencing crises that necessitated immediate admission to hospital', 'severely ill patients in acute crises', 'mentally ill patients', 'acute mental healthcare']",['service model including a home treatment alternative to hospital care (experimental group) or a conventional service model that lacked a home treatment alternative to in-patient care (control group) (trial registration at ClinicalTrials.gov'],"['average overall treatment duration (hospital days + home treatment days) per patient', 'patient satisfaction with care (Perception of Care questionnaire', 'mean number of hospital admissions', 'mean number of hospital days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025360', 'cui_str': 'Mentally Ill'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0017313'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",707.0,0.0771763,"There were no significant between-group differences regarding clinical and social outcomes (Health of the Nation Outcome Scales: mean 9.9 v. 9.7, P = 0.652) or patient satisfaction with care (Perception of Care questionnaire: mean 0.78 v. 0.80, P = 0.242).
","[{'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Stulz', 'Affiliation': 'Head of Research, Integrated Psychiatric Services Winterthur - Zurcher Unterland; Senior Researcher (Former Head of Research), Psychiatric Services Aargau; and Research Associate, Department of Psychology, University of Berne, Switzerland.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Wyder', 'Affiliation': 'Research Associate, Psychiatric Services Aargau; and Former PhD Student, Department of Psychology, University of Berne, Switzerland.'}, {'ForeName': 'Lienhard', 'Initials': 'L', 'LastName': 'Maeck', 'Affiliation': 'Senior Physician, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Hilpert', 'Affiliation': 'Deputy Head of Department, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Lerzer', 'Affiliation': 'Deputy Head of Nursing Services, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Zander', 'Affiliation': 'Senior Physician, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Kawohl', 'Affiliation': 'Head of Department, Psychiatric Services Aargau, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Associate Professor, Department of Psychology, University of Berne; and Head Researcher, Division of Psychosomatic Medicine, Department of Neurology, Inselspital, University Hospital Berne, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schnyder', 'Affiliation': 'Emeritus Professor, University of Zurich, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Hepp', 'Affiliation': 'Medical Director, Integrated Psychiatric Services Winterthur - Zurcher Unterland, Switzerland.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.31']
665,31823527,"Pharmacokinetics, Pharmacodynamics, and Safety of a Single Escalating Dose and Repeated Doses of Rasagiline Transdermal Patch in Healthy Chinese Subjects.","A rasagiline transdermal patch can be used to offer continuous rasagiline to patients with Parkinson's disease who cannot take their usual oral medications. This was the first study to investigate the pharmacokinetics, pharmacodynamics, and safety of the rasagiline transdermal patch in healthy Chinese subjects. Thirty subjects were randomized to 3 groups with 10 subjects in each group. The 10 subjects of group 1 received a single 1-mg dose of rasagiline as a tablet; the 20 subjects of groups 2 and 3 received a single transdermal patch (48-hour patch-on period) containing 1.25 mg and 2.5 mg rasagiline, respectively. After a 2-week washout period, the subjects of group 1 were assigned to receive 1 mg of rasagiline tablets every 24 hours for 7 days, and the subjects of group 2 were assigned to receive 1.25-mg rasagiline transdermal patches (48-hour patch-on period) every 72 hours for 5 time periods. The absorption of rasagiline from the transdermal patch was significantly improved, although the peak plasma concentration was obviously reduced. There was slight accumulation of rasagiline dose after multiple administrations. Inhibition of platelet monoamine oxidase-B (MAO-B) activity was dose dependent. The 80% inhibition maintained for at least 48 hours after multiple-dose administration of 1 mg tablets, and for 72 hours after multiple-dose administration of 1.25 mg/48 h patch. Compared with rasagiline tablets, the transdermal patch had a prolonged duration of 80% inhibition and increased maximal inhibition of MAO-B activity. These characteristics permitted an interval of 3 days of dosing, which was convenient for patients to use.",2020,"Compared with rasagiline tablets, the transdermal patch had a prolonged duration of 80% inhibition and increased maximal inhibition of MAO-B activity.","['Healthy Chinese Subjects', 'Thirty subjects were randomized to 3 groups with 10 subjects in each group', ""patients with Parkinson's disease who cannot take their usual oral medications"", 'healthy Chinese subjects']","['single transdermal patch (48-hour patch-on period) containing 1.25 mg and 2.5\xa0mg rasagiline', 'single 1-mg dose of rasagiline', 'platelet monoamine oxidase-B', '1.25-mg rasagiline transdermal patches', 'rasagiline tablets', 'Rasagiline Transdermal Patch', 'rasagiline transdermal patch']","['absorption of rasagiline', 'peak plasma concentration', 'maximal inhibition of MAO-B activity', 'MAO-B) activity', 'pharmacokinetics, pharmacodynamics, and safety', 'Pharmacokinetics, Pharmacodynamics, and Safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517497', 'cui_str': '1.25 (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0026456', 'cui_str': 'MAO-B'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0525678', 'cui_str': 'rasagiline'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0026456', 'cui_str': 'MAO-B'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.0256371,"Compared with rasagiline tablets, the transdermal patch had a prolonged duration of 80% inhibition and increased maximal inhibition of MAO-B activity.","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Quanying', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Shunlin', 'Initials': 'S', 'LastName': 'Zong', 'Affiliation': 'Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, Suzhou City, Jiangsu Province, China.'}, {'ForeName': 'Chengzhe', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': ""Department of Pharmaceutics, Children's Hospital of Soochow University, Suzhou City, Jiangsu Province, China.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.761']
666,30209589,A phase I/randomized phase II study of GM.CD40L vaccine in combination with CCL21 in patients with advanced lung adenocarcinoma.,"The GM.CD40L vaccine, which recruits and activates dendritic cells, migrates to lymph nodes, activating T cells and leading to systemic tumor cell killing. When combined with the CCL21 chemokine, which recruits T cells and enhances T-cell responses, additive effects have been demonstrated in non-small cell lung cancer mouse models. Here, we compared GM.CD40L versus GM.CD40L plus CCL21 (GM.CD40L.CCL21) in lung adenocarcinoma patients with ≥ 1 line of treatment. In this phase I/II randomized trial (NCT01433172), patients received intradermal vaccines every 14 days (3 doses) and then monthly (3 doses). A two-stage minimax design was used. During phase I, no dose-limiting toxicities were shown in three patients who received GM.CD40L.CCL21. During phase II, of evaluable patients, 5/33 patients (15.2%) randomized for GM.DCD40L (p = .023) and 3/32 patients (9.4%) randomized for GM.DCD40L.CCL21 (p = .20) showed 6-month progression-free survival. Median overall survival was 9.3 versus 9.5 months with GM.DCD40L versus GM.DCD40L.CCL21 (95% CI 0.70-2.25; p = .44). For GM.CD40L versus GM.CD40L.CCL21, the most common treatment-related adverse events (TRAEs) were grade 1/2 injection site reaction (51.4% versus 61.1%) and grade 1/2 fatigue (35.1% versus 47.2%). Grade 1 immune-mediated TRAEs were isolated to skin. No patients showed evidence of pseudo-progression or immune-related TRAEs of grade 1 or greater of pneumonitis, endocrinopathy, or colitis, and none discontinued treatment due to toxicity. Although we found no significant associations between vaccine immunogenicity and outcomes, in limited biopsies, one patient treated with GMCD40L.CCL21 displayed abundant tumor-infiltrating lymphocytes. This possible effectiveness warrants further investigation of GM.CD40L in combination approaches.",2018,"No patients showed evidence of pseudo-progression or immune-related TRAEs of grade 1 or greater of pneumonitis, endocrinopathy, or colitis, and none discontinued treatment due to toxicity.","['patients with advanced lung adenocarcinoma', 'lung adenocarcinoma patients with ≥\u20091 line of treatment']","['GM.DCD40L.CCL21', 'GM.CD40L.CCL21', 'GM.CD40L vaccine', 'intradermal vaccines', 'GM.CD40L versus GM.CD40L plus CCL21 (GM.CD40L.CCL21', 'CCL21']","['6-month progression-free survival', 'evidence of pseudo-progression or immune-related TRAEs of grade 1 or greater of pneumonitis, endocrinopathy, or colitis', 'grade 1/2 fatigue', 'Grade 1 immune-mediated TRAEs', 'Median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3714636', 'cui_str': 'Pulmonary Inflammation'}, {'cui': 'C0014130', 'cui_str': 'Endocrine System Diseases'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0517418,"No patients showed evidence of pseudo-progression or immune-related TRAEs of grade 1 or greater of pneumonitis, endocrinopathy, or colitis, and none discontinued treatment due to toxicity.","[{'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB1, Tampa, FL, 33612, USA. Jhanelle.gray@moffitt.org.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB1, Tampa, FL, 33612, USA.'}, {'ForeName': 'Charlie C', 'Initials': 'CC', 'LastName': 'Williams', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB1, Tampa, FL, 33612, USA.'}, {'ForeName': 'Tawee', 'Initials': 'T', 'LastName': 'Tanvetyanon', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB1, Tampa, FL, 33612, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Haura', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB1, Tampa, FL, 33612, USA.'}, {'ForeName': 'Ben C', 'Initials': 'BC', 'LastName': 'Creelan', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB1, Tampa, FL, 33612, USA.'}, {'ForeName': 'Jongphil', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Boyle', 'Affiliation': 'Department of Anatomic Pathology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pinder-Schenck', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Khalil', 'Affiliation': 'Department of Anatomic Pathology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Soner', 'Initials': 'S', 'LastName': 'Altiok', 'Affiliation': 'Department of Anatomic Pathology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Devane', 'Affiliation': 'Clinical Trials Office, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Noyes', 'Affiliation': 'Clinical Science Lab (Antonia Lab), H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Mediavilla-Varela', 'Affiliation': 'Clinical Science Lab (Antonia Lab), H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Smilee', 'Affiliation': 'Cell Therapy Core, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Hopewell', 'Affiliation': 'Cell Therapy Core, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kelley', 'Affiliation': 'Cell Therapy Core, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, FOB1, Tampa, FL, 33612, USA.'}]","Cancer immunology, immunotherapy : CII",['10.1007/s00262-018-2236-7']
667,26413083,Preliminary assessment of Hedychium coronarium essential oil on fibrinogenolytic and coagulant activity induced by Bothrops and Lachesis snake venoms.,"BACKGROUND
The search for new inhibitors of snake venom toxins is essential to complement or even replace traditional antivenom therapy, especially in relation to compounds that neutralize the local effects of envenomations. Besides their possible use as alternative to traditional antivenom therapy, some plant species possess bioactive secondary metabolites including essential oils, which can be extracted from weeds that are considered substantial problems for agriculture, such as Hedychium coronarium.
METHODS
The essential oils of leaves and rhizomes from H. coronarium were extracted by hydrodistillation, and their potential inhibitory effects on the coagulant and fibrinogenolytic activities induced by the venoms of Lachesis muta, Bothrops atrox and Bothrops moojeni were analyzed. Citrated human plasma was used to evaluate the clotting time whereas changes in fibrinogen molecules were visualized by electrophoresis in polyacrylamide gel. The experimental design used for testing coagulation inhibition was randomized in a 3 × 2 factorial arrangement (concentration × essential oils), with three replications. The essential oils were compared since they were extracted from different organs of the same botanical species, H. coronarium.
RESULTS
The results suggest that the oils interact with venom proteases and plasma constituents, since all oils evaluated, when previously incubated with venoms, were able to inhibit the clotting effect, with less inhibition when oils and plasma were preincubated prior to the addition of venoms.
CONCLUSIONS
Thus, after extensive characterization of their pharmacological and toxicological effects, the essential oils can be used as an alternative to complement serum therapy, especially considering that these plant metabolites generally do not require specific formulations and may be used topically immediately after extraction.",2014,Citrated human plasma was used to evaluate the clotting time whereas changes in fibrinogen molecules were visualized by electrophoresis in polyacrylamide gel.,[],['Hedychium coronarium essential oil'],"['fibrinogenolytic and coagulant activity', 'clotting time']",[],"[{'cui': 'C1080914', 'cui_str': 'Hedychium'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}]","[{'cui': 'C0009117', 'cui_str': 'Coagulants'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0195095,Citrated human plasma was used to evaluate the clotting time whereas changes in fibrinogen molecules were visualized by electrophoresis in polyacrylamide gel.,"[{'ForeName': 'Cíntia A Sf', 'Initials': 'CA', 'LastName': 'Miranda', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Cardoso', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil ; Laboratório de Química Orgânica, Departamento de Química, Universidade Federal de Lavras, Caixa postal 3037, CEP 37200-000 Lavras, MG, Brasil.'}, {'ForeName': 'Mariana E', 'Initials': 'ME', 'LastName': 'Mansanares', 'Affiliation': 'Department of Biology, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}, {'ForeName': 'Marcos S', 'Initials': 'MS', 'LastName': 'Gomes', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Marcussi', 'Affiliation': 'Department of Chemistry, Federal University of Lavras (UFLA), Lavras, Minas Gerais State, Brazil.'}]",The journal of venomous animals and toxins including tropical diseases,['10.1186/1678-9199-20-39']
668,30783732,Inhaled steroids associated with decreased macrophage markers in nonasthmatic individuals with sickle cell disease in a randomized trial.,"Inhaled mometasone was shown to improve pain scores and decrease soluble vascular cell adhesion molecule (sVCAM) concentration in a randomized controlled trial of nonasthmatic patients with sickle cell disease. We sought to explore potential changes in systemic inflammation as a mechanism underlying this effect. Serum samples from 41 trial participants (15 placebo- and 26 mometasone-treated) were analyzed using a 92 inflammatory marker panel at baseline and after 8 weeks of mometasone therapy. Individual marker analysis and correlation analysis were conducted. Adjusted for age, the mometasone-treated group decreased the concentration of CXCL9, CXCL11, CD40, IL-10, and IL-18 relative to placebo-treated participants. Hierarchical clustering and correlation analysis identified additional evidence for a decrease in cytokines linking to macrophage signaling and migration. There was no statistically significant change in markers of asthma and allergy, indicating that the improvement was unlikely mediated by modulation of occult reactive airway disease. This analysis of inflammatory markers suggests that decrease in macrophage activity may be involved in the mediation of the clinical benefit seen with use of inhaled mometasone in nonasthmatic patients with sickle cell disease.Trial registration: clinicaltrials.gov identifier: NCT02061202.",2019,Inhaled mometasone was shown to improve pain scores and decrease soluble vascular cell adhesion molecule (sVCAM) concentration in a randomized controlled trial of nonasthmatic patients with sickle cell disease.,"['nonasthmatic patients with sickle cell disease', 'nonasthmatic individuals with sickle cell disease']","['mometasone therapy', 'mometasone', 'Inhaled mometasone', 'Inhaled steroids']","['macrophage markers', 'concentration of CXCL9, CXCL11, CD40, IL-10, and IL-18 relative', 'pain scores', 'markers of asthma and allergy', 'soluble vascular cell adhesion molecule (sVCAM) concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0360564', 'cui_str': 'Mometasone'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}]",,0.447673,Inhaled mometasone was shown to improve pain scores and decrease soluble vascular cell adhesion molecule (sVCAM) concentration in a randomized controlled trial of nonasthmatic patients with sickle cell disease.,"[{'ForeName': 'Arielle L', 'Initials': 'AL', 'LastName': 'Langer', 'Affiliation': 'Division of Hematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leader', 'Affiliation': 'Department of Oncological Science, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Seunghee', 'Initials': 'S', 'LastName': 'Kim-Schulze', 'Affiliation': 'Department of Oncological Science, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Ginzburg', 'Affiliation': 'Division of Hematology and Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Merad', 'Affiliation': 'Department of Oncological Science, Icahn School of Medicine at Mount Sinai, New York, NY, 10029, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Glassberg', 'Affiliation': 'Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1620, New York, NY, 10029-6574, USA. Jeffrey.glassberg@mountsinai.org.'}]",Annals of hematology,['10.1007/s00277-019-03635-9']
669,30897067,THE EFFECT OF AGE ON AFLIBERCEPT (EYLEA) RESPONSE IN DIABETIC MACULAR EDEMA.,"PURPOSE
To investigate the effect of age on aflibercept (Eylea) response in macular edema secondary to treatment-naive diabetic eyes.
METHODS
Two hundred seventy-three eyes of 273 treatment-naive patients with macular edema secondary to diabetes mellitus were enrolled in this study. The patients in the study were divided into the following 4 groups according to their ages: Group 1 (40-50 years), Group 2 (51-60 years), Group 3 (61-70 years), and Group 4 (>70 years). Three consecutive injections at intervals of 1 month were applied to all diabetic patients. The efficacy of the aflibercept treatment on macular edema according to age groups was assessed by optical coherence tomography by comparing the central foveal thickness (CFT) values and mean visual acuity changes after initial and three loading dose injections.
RESULTS
After three consecutive aflibercept injections, the mean reduction of CFT in Groups 1, 2, 3, and 4 were -256.4 ± 110.9, -197.4 ± 96.4, -189.4 ± 110.8, and -186.2 ± 118.9 µm, respectively. The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance). The improvement of visual acuity was significantly different in each group (P < 0.001 in all groups, paired-samples t-test), and changes of visual acuity was significantly different between age groups (P < 0.05, analysis of covariance). In addition, ages of patients were correlated with the mean reduction of CFT and mean improvement of visual acuity for the whole study group (r = -0.183, P = 0.002 for CFT; r = -0.682, P < 0.001 for visual acuity, Pearson correlation).
CONCLUSION
In this study, it was observed that the efficacy of aflibercept treatment was found to be more effective in younger patients in treatment-naive diabetic macular edema patients.",2020,"The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance).","['younger patients in treatment-naive diabetic macular edema patients', 'macular edema secondary to treatment-naive diabetic eyes', 'Two hundred seventy-three eyes of 273 treatment-naive patients with macular edema secondary to diabetes mellitus']","['aflibercept', 'aflibercept (Eylea) response', 'THE EFFECT OF AGE ON AFLIBERCEPT (EYLEA']","['macular edema', 'changes of CFT', 'visual acuity', 'changes of visual acuity', 'central foveal thickness (CFT) values and mean visual acuity changes', 'improvement of visual acuity', 'mean reduction of CFT']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}]","[{'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",273.0,0.0287596,"The changes of CFT was significantly different between age groups (P = 0.003, analysis of covariance).","[{'ForeName': 'Cemal', 'Initials': 'C', 'LastName': 'Ozsaygili', 'Affiliation': 'Kayseri City Training and Research Hospital, Kocasinan, Kayseri, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Duru', 'Affiliation': ''}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Cicek', 'Affiliation': ''}, {'ForeName': 'Dondu Melek', 'Initials': 'DM', 'LastName': 'Ulusoy', 'Affiliation': ''}, {'ForeName': 'Atilim Armagan', 'Initials': 'AA', 'LastName': 'Demirtas', 'Affiliation': ''}, {'ForeName': 'Necati', 'Initials': 'N', 'LastName': 'Duru', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002504']
670,31699751,Best emollients for eczema (BEE) - comparing four types of emollients in children with eczema: protocol for randomised trial and nested qualitative study.,"INTRODUCTION
Atopic dermatitis/eczema affects around 20% of children and is characterised by inflamed, dry, itchy skin. Guidelines recommend 'leave-on' emollients that are applied directly to the skin to add or trap moisture and used regularly, they can soothe, enhance the skin barrier and may prevent disease 'flares'. However, the suitability of the many different emollients varies between people and there is little evidence to help prescribers and parents and carers decide which type to try first.
METHODS AND ANALYSIS
Design: pragmatic, multicentre, individually randomised, parallel group superiority trial of four types of emollient (lotions, creams, gel or ointments).
SETTING
general practitioner surgeries in England.
PARTICIPANTS
children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients.
INTERVENTIONS
study-approved lotion, cream, gel or ointment as the only leave-on emollient for 16 weeks, with directions to apply twice daily and as required. Other treatments, such as topical corticosteroids, used as standard care.
FOLLOW-UP
52 weeks.
PRIMARY OUTCOME
validated patient-orientated eczema measure measured weekly for 16 weeks.
SECONDARY OUTCOMES
eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).
SAMPLE SIZE
520 participants (130 per group).
ANALYSIS
intention-to-treat using linear mixed models for repeated measures.Nested qualitative study: audio-recording of sample of baseline appointments and up to 60 interviews with participants at 4 and 16 weeks, interviews to be transcribed and analysed thematically.
ETHICS AND DISSEMINATION
Ethics approval granted by the NHS REC (South West - Central Bristol Research Ethics Committee 17/SW/0089). Findings will be presented at conferences, published in open-access peer-reviewed journals and the study website; and summaries shared with key stakeholders.
TRIAL REGISTRATION NUMBER
ISRCTN84540529.",2019,"OUTCOMES
eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).
","['520 participants (130 per group', 'children aged over 6 months and less than 12 years with mild-to-severe eczema and no known sensitivity to study emollients', 'general practitioner surgeries in England', 'children with eczema']","['emollient (lotions, creams, gel or ointments', 'lotion, cream, gel or ointment']","['eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact']","[{'cui': 'C4517803', 'cui_str': '520 (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0013983', 'cui_str': 'Emollients'}, {'cui': 'C0544341', 'cui_str': 'Lotion (basic dose form)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0034380'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",520.0,0.186668,"OUTCOMES
eczema signs (Eczema Area Severity Index) by masked researcher, treatment use, parent satisfaction, adverse events, child and family quality of life (Atopic Dermatitis Quality of Life, Child Health Utility 9D and Dermatitis Family Impact).
","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ridd', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK m.ridd@bristol.ac.uk.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Wells', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Edwards', 'Affiliation': 'Faculty of Health Sciences, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Santer', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Southampton, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'MacNeill', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Sutton', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alison R G', 'Initials': 'ARG', 'LastName': 'Shaw', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Banks', 'Affiliation': 'National Institute for Health Research Collaborations for Leadership in Applied Health Research and Care West (NIHR CLAHRC West), University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roberts', 'Affiliation': 'Nottingham Support Group for Carers of Children with Eczema, Nottingham, UK.'}, {'ForeName': 'Tiffany J', 'Initials': 'TJ', 'LastName': 'Barrett', 'Affiliation': 'South West Medicines Information & Training, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Baxter', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Hay', 'Affiliation': 'Centre for Academic Primary Care, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Hywel C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Kim Suzanne', 'Initials': 'KS', 'LastName': 'Thomas', 'Affiliation': 'Centre of Evidence-Based Dermatology, University of Nottingham, Nottingham, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033387']
671,32022282,"A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.","AIMS
Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim) is indicated for the reduction of chemotherapy-induced neutropenia and prevention of febrile neutropenia. Biosimilar pegfilgrastim is expected to reduce the financial burden of this complication of chemotherapy. The aim of this study was to demonstrate biosimilarity between Sandoz biosimilar pegfilgrastim and its US- and EU-approved reference biologics.
METHODS
Phase I, randomized, double-blind, single-dose, 3-period, 6-sequence cross-over, multicentre study to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of Sandoz biosimilar pegfilgrastim with US- and EU-references in healthy adults.
RESULTS
Pharmacokinetic and pharmacodynamic similarity was demonstrated between the 3 biologics, as the 90% confidence interval for all primary pharmacokinetic and pharmacodynamic endpoint comparisons were contained within the predefined similarity margins of 0.80-1.25. Safety, immunogenicity and tolerability were also similar.
CONCLUSIONS
Sandoz biosimilar pegfilgrastim demonstrated pharmacokinetic and pharmacodynamic similarity to both US- and EU-reference biologics. No meaningful differences in safety, local tolerability and immunogenicity were identified.",2020,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","['healthy adults', 'healthy volunteers']","['Recombinant PEGylated human granulocyte colony-stimulating factor (pegfilgrastim', 'Sandoz biosimilar pegfilgrastim with US- and EU-references', 'pegfilgrastim biosimilar with its US- and EU-reference biologics', 'Biosimilar pegfilgrastim']","['pharmacokinetics, pharmacodynamics, safety, and immunogenicity', 'Pharmacokinetic (PK) and pharmacodynamic (PD) similarity', 'safety, local tolerability, and immunogenicity', 'Safety, immunogenicity, and tolerability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",,0.248203,"No meaningful differences in safety, local tolerability, and immunogenicity were identified.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bellon', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Skerjanec', 'Affiliation': 'Sandoz AG, Novartis, Basel, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Velinova', 'Affiliation': 'PRAHS, Groningen, The Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Dickerson', 'Affiliation': 'PRAHS, Lenexa, KS, USA.'}, {'ForeName': 'Ahad', 'Initials': 'A', 'LastName': 'Sabet', 'Affiliation': 'PRAHS, Salt Lake City, UT, USA.'}, {'ForeName': 'Ly', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'PRAHS, Marlton, NJ, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion, Tempe, AZ, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Tomek', 'Affiliation': 'Celerion, Lincoln, NE, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Schussler', 'Affiliation': 'Novartis, Princeton, NJ, USA.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schier-Mumzhiu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Gattu', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Sven D', 'Initials': 'SD', 'LastName': 'Koch', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Schelcher', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Miryana', 'Initials': 'M', 'LastName': 'Dobreva', 'Affiliation': 'Sandoz, Novartis, Sofia, Bulgaria.'}, {'ForeName': 'Anca', 'Initials': 'A', 'LastName': 'Boldea', 'Affiliation': 'Sandoz Pharma Services Romania SRL, Novartis, Bucharest, Romania.'}, {'ForeName': 'Roumen', 'Initials': 'R', 'LastName': 'Nakov', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}, {'ForeName': 'Gordon P', 'Initials': 'GP', 'LastName': 'Otto', 'Affiliation': 'Hexal AG, Novartis, Holzkirchen, Germany.'}]",British journal of clinical pharmacology,['10.1111/bcp.14226']
672,30415610,Low-Dose Methotrexate for the Prevention of Atherosclerotic Events.,"BACKGROUND
Inflammation is causally related to atherothrombosis. Treatment with canakinumab, a monoclonal antibody that inhibits inflammation by neutralizing interleukin-1β, resulted in a lower rate of cardiovascular events than placebo in a previous randomized trial. We sought to determine whether an alternative approach to inflammation inhibition with low-dose methotrexate might provide similar benefit.
METHODS
We conducted a randomized, double-blind trial of low-dose methotrexate (at a target dose of 15 to 20 mg weekly) or matching placebo in 4786 patients with previous myocardial infarction or multivessel coronary disease who additionally had either type 2 diabetes or the metabolic syndrome. All participants received 1 mg of folate daily. The primary end point at the onset of the trial was a composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Near the conclusion of the trial, but before unblinding, hospitalization for unstable angina that led to urgent revascularization was added to the primary end point.
RESULTS
The trial was stopped after a median follow-up of 2.3 years. Methotrexate did not result in lower interleukin-1β, interleukin-6, or C-reactive protein levels than placebo. The final primary end point occurred in 201 patients in the methotrexate group and in 207 in the placebo group (incidence rate, 4.13 vs. 4.31 per 100 person-years; hazard ratio, 0.96; 95% confidence interval [CI], 0.79 to 1.16). The original primary end point occurred in 170 patients in the methotrexate group and in 167 in the placebo group (incidence rate, 3.46 vs. 3.43 per 100 person-years; hazard ratio, 1.01; 95% CI, 0.82 to 1.25). Methotrexate was associated with elevations in liver-enzyme levels, reductions in leukocyte counts and hematocrit levels, and a higher incidence of non-basal-cell skin cancers than placebo.
CONCLUSIONS
Among patients with stable atherosclerosis, low-dose methotrexate did not reduce levels of interleukin-1β, interleukin-6, or C-reactive protein and did not result in fewer cardiovascular events than placebo. (Funded by the National Heart, Lung, and Blood Institute; CIRT ClinicalTrials.gov number, NCT01594333.).",2019,"Methotrexate did not result in lower interleukin-1β, interleukin-6, or C-reactive protein levels than placebo.","['patients with stable atherosclerosis', '4786 patients with previous myocardial infarction or multivessel coronary disease who additionally had either type 2 diabetes or the metabolic syndrome']","['matching placebo', 'Methotrexate', 'methotrexate', 'placebo', 'Low-Dose Methotrexate']","['leukocyte counts and hematocrit levels', 'lower interleukin-1β, interleukin-6, or C-reactive protein levels', 'higher incidence of non-basal-cell skin cancers', 'composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death', 'rate of cardiovascular events', 'cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",4786.0,0.682607,"Methotrexate did not result in lower interleukin-1β, interleukin-6, or C-reactive protein levels than placebo.","[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Pradhan', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Jean G', 'Initials': 'JG', 'LastName': 'MacFadyen', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Zaharris', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Virak', 'Initials': 'V', 'LastName': 'Mam', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Iturriaga', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Tsigoulis', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clearfield', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Libby', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Seagle', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Ofori', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Saklayen', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Butman', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Narendra', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Le May', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bertrand', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Johnston', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (P.M.R., B.M.E., A.P., J.G.M., E.Z., V.M., N.P.P., R.J.G.), and the Divisions of Cardiovascular Medicine (P.M.R., B.M.E., P.L., S.Z.G.) and Rheumatology (D.H.S.), Brigham and Women's Hospital, Boston; the National Heart, Lung, and Blood Institute, Bethesda, MD (A.H., Y.R., E.I.); McMaster University, Hamilton (M.G.), the Canadian Collaborative Research Network, Brampton (M.T.), St. Michael's Hospital, Toronto (S.V.), the University of Ottawa Heart Institute, Ottawa (M.L.M.), and KMH Cardiology, Diagnostic and Research Centres, Mississauga (J.J.), ON, and Laval University, Quebec City, QB (O.B.) - all in Canada; Touro University, Vallejo, CA (M.C.); Cardiology Associates Carolina, Morganton, NC (R.S.); Wooster Community Hospital, Wooster (C.O.), and Dayton Veteran Affairs Medical Center, Dayton (M.S.) - both in Ohio; Verde Valley Medical Center, Cottonwood, AZ (S.B.); and Atlanta Heart Specialists, Atlanta (N.S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1809798']
673,30801257,Improving Nutrition and Activity Behaviors Using Digital Technology and Tailored Feedback: Protocol for the Tailored Diet and Activity (ToDAy) Randomized Controlled Trial.,"BACKGROUND
Excess weight is a major risk factor for chronic diseases. In Australia, over 60% of adults are overweight or obese. The overconsumption of energy-dense nutrient-poor (EDNP) foods and low physical activity (PA) levels are key factors contributing to population obesity. New cost-effective approaches to improve population diet and PA behaviors are needed.
OBJECTIVE
This 1-year randomized controlled trial (6-month intervention and 6-month follow-up) aims to investigate whether a tailored intervention using mobile technology can improve diet and PA behaviors leading to weight loss in adults (aged 18-65 years) who are overweight or obese and recruited through a social marketing campaign (LiveLighter).
METHODS
All eligible participants will provide data on demographics and lifestyle behaviors online at baseline, 6 months, and 12 months. Using two-stage randomization, participants will be allocated into one of three conditions (n=200 per group): tailored feedback delivered via email at seven time points, informed by objective dietary (mobile food record app) and activity (wearable activity monitor) assessment; active control receiving no tailored feedback, but undergoing the same objective assessments as tailored feedback; and online control receiving no tailored feedback or objective assessments. Primary outcome measures at 6 and 12 months are changes in body mass, EDNP food and beverage consumption, and daily moderate-to-vigorous PA (measured via accelerometry). Secondary outcomes include change in fruit and vegetable consumption, daily sedentary behaviors, and cost effectiveness.
RESULTS
Enrolment commenced in August 2017. Primary outcomes at 12 months will be available for analysis from September 2019.
CONCLUSIONS
Tailored email feedback provided to individuals may deliver a cost-effective strategy to overcome existing barriers to improving diet and PA. If found to be successful and cost effective, upscaling this intervention for inclusion in larger-scale interventions is highly feasible.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry ACTRN12617000554369; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=371325&isReview=true.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/12782.",2019,"CONCLUSIONS
Tailored email feedback provided to individuals may deliver a cost-effective strategy to overcome existing barriers to improving diet and PA.","['adults (aged 18-65 years) who are overweight or obese and recruited through a social marketing campaign (LiveLighter', 'All eligible participants will provide data on demographics and lifestyle behaviors online at baseline, 6 months, and 12 months']","['Digital Technology and Tailored Feedback', 'tailored feedback delivered via email at seven time points, informed by objective dietary (mobile food record app) and activity (wearable activity monitor) assessment; active control receiving no tailored feedback, but undergoing the same objective assessments as tailored feedback; and online control receiving no tailored feedback or objective assessments', 'LiveLighter Tailored Diet and Activity (ToDAy']","['changes in body mass, EDNP food and beverage consumption, and daily moderate-to-vigorous PA (measured via accelerometry', 'change in fruit and vegetable consumption, daily sedentary behaviors, and cost effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037424', 'cui_str': 'Social Marketing'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0310367', 'cui_str': 'Today'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0524819', 'cui_str': 'Food and Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.180571,"CONCLUSIONS
Tailored email feedback provided to individuals may deliver a cost-effective strategy to overcome existing barriers to improving diet and PA.","[{'ForeName': 'Rhiannon E', 'Initials': 'RE', 'LastName': 'Halse', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Charlene L', 'Initials': 'CL', 'LastName': 'Shoneye', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Pollard', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jonine', 'Initials': 'J', 'LastName': 'Jancey', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Scott', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'Pratt', 'Affiliation': 'Cancer Council WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Satvinder S', 'Initials': 'SS', 'LastName': 'Dhaliwal', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Norman', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Leon M', 'Initials': 'LM', 'LastName': 'Straker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Boushey', 'Affiliation': 'Cancer Epidemiology Program, University of Hawaii Cancer Center, Honolulu, HI, United States.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Delp', 'Affiliation': 'School of Electrical and Computer Engineering, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'School of Electrical and Computer Engineering, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Harray', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Szybiak', 'Affiliation': 'Cancer Council WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Finch', 'Affiliation': 'Cancer Council WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'McVeigh', 'Affiliation': 'School of Occupational Therapy, Speech Therapy & Social Work, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mullan', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Syed Aqif', 'Initials': 'SA', 'LastName': 'Mukhtar', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Kieran N', 'Initials': 'KN', 'LastName': 'Edwards', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Janelle D', 'Initials': 'JD', 'LastName': 'Healy', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}]",JMIR research protocols,['10.2196/12782']
674,30837192,"Effectiveness of balance exercise among older adults in Depok City, Indonesia.","OBJECTIVE
Falls are a serious problem for older adults. Balance impairment is one of the most significant reasons why adults fall from a standing position. This study aims to investigate the effect of an eight-week postural balance exercise intended to reduce the risk of falls among older adults in a community in Depok City, Indonesia.
METHOD
This quasi-experimental study employed a pre- and post-test design using a control group. The study involved an intervention group of 30 respondents and a control group of a further 30 respondents. The sample was selected using multistage random sampling. The data were analyzed using a t-test.
RESULTS
The balance exercise significantly affected the respondents' postural balance and reduced their risk of falling. There were significant differences between the two groups (intervention group and control group) in postural balance (p < 0.001) and the risk of suffering a fall (p = 0.023). CONCLUSIóN: Balance exercises can be utilized as one of the preventive efforts to maintain postural balance and reduce the risk of falls among older adults. Future studies may consider the variation of age to more accurately determine the effectiveness of this balance exercise.",2020,"There were significant differences between the two groups (intervention group and control group) in postural balance (p<.001) and the risk of suffering a fall (p=.023).
","['older adults in a community in Depok City, Indonesia', '30 respondents and a control group of a further 30 respondents', 'older adults in Depok City, Indonesia', 'older adults']","['balance exercise', 'eight-week postural balance exercise', 'Balance exercises']","['risk of falling', 'postural balance (p<.001) and the risk of suffering a fall (p=.023', 'risk of falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1256755', 'cui_str': 'Postural Equilibrium'}]",,0.0211157,"There were significant differences between the two groups (intervention group and control group) in postural balance (p<.001) and the risk of suffering a fall (p=.023).
","[{'ForeName': 'Stefanus Mendes', 'Initials': 'SM', 'LastName': 'Kiik', 'Affiliation': 'Stikes Maranatha Kupang, East Nusa Tenggara, Indonesia; Faculty of Nursing, Universitas Indonesia, West Java, Indonesia. Electronic address: stefanusmendeskiik@ymail.com.'}, {'ForeName': 'Junaiti', 'Initials': 'J', 'LastName': 'Sahar', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, West Java, Indonesia.'}, {'ForeName': 'Henny', 'Initials': 'H', 'LastName': 'Permatasari', 'Affiliation': 'Faculty of Nursing, Universitas Indonesia, West Java, Indonesia.'}]",Enfermeria clinica,['10.1016/j.enfcli.2019.01.004']
675,29927290,The effect of a parenting intervention on relationship quality of recently deployed military service members and their partners.,"Couples form the foundation of military families. However, on average, couples become significantly less satisfied with their relationships and marriages across the deployment cycle. Reduced satisfaction places partners at risk for psychological distress and family problems. The present study examines the effects of a family based reintegration program aimed at enhancing reflective functioning in recently deployed service members and their home-front partners on relationship satisfaction. Results reveal that most dyads report being satisfied in their relationship at baseline. However, greater couple distress was related to more psychological distress in both partners. For spouses, intervention had a positive, significant effect on relationship satisfaction. Variations in relative risk for couple distress among service members and their spouses highlight the need to assess both partners to clarify risk factors and modifiable targets of intervention. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"For spouses, intervention had a positive, significant effect on relationship satisfaction.",['recently deployed military service members and their partners'],"['family based reintegration program', 'parenting intervention']","['relationship satisfaction', 'psychological distress', 'relationship quality']","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.022868,"For spouses, intervention had a positive, significant effect on relationship satisfaction.","[{'ForeName': 'Tessa K', 'Initials': 'TK', 'LastName': 'Kritikos', 'Affiliation': 'Department of Psychological and Brain Sciences.'}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'DeVoe', 'Affiliation': 'School of Social Work.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Emmert-Aronson', 'Affiliation': 'Department of Psychological and Brain Sciences.'}]",The American journal of orthopsychiatry,['10.1037/ort0000344']
676,29999394,A randomized controlled trial of a mentalization-based intervention (MBT-FACTS) for families of people with borderline personality disorder.,"This article reports a delayed-treatment randomized controlled trial of a mentalization-based intervention for families or significant others living with or supporting a person with borderline personality disorder (BPD). In all, 56 family members/significant others living with/supporting people with a diagnosis of BPD were randomized either to immediate mentalization-based Families and Carers Training and Support, a supportive and skills-based program consisting of five 1.5- to 2-hr evening meetings, delivered by trained family members, or to delayed intervention. The primary outcome was adverse incidents reported by the family member in relation to the person with BPD. Secondary outcomes included self-reported family well-being, empowerment, burden, and levels of anxiety and depression. Family members randomized to immediate intervention showed a significant reduction in reported adverse incidents between themselves and the identified patient in the second phase of treatment compared with those randomized to delayed intervention. Analysis of the rate of change indicated a significantly steeper decline for the immediate-treatment group compared with the delayed-intervention group (β = -1.07, 95% confidence interval [-1.40, -0.74], z = -6.3, p < .000). Secondary outcome measures showed family functioning and well-being improved more in the immediate-treatment group; changes were maintained at follow-up. There were no differences in depression, total anxiety, and total burden; both groups showed improvement on all these measures. Findings show that the mentalization-based Families and Carers Training and Support program delivered by families to families supporting a person with BPD reduces reported adverse incidents within the family. Further studies are needed to show whether this reduction improves outcomes for the individual with BPD. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Secondary outcome measures showed family functioning and well-being improved more in the immediate-treatment group; changes were maintained at follow-up.,"['56 family members/significant others living with/supporting people with a diagnosis of BPD', 'families or significant others living with or supporting a person with borderline personality disorder (BPD', 'families of people with borderline personality disorder']","['mentalization-based intervention', 'mentalization-based intervention (MBT-FACTS', 'immediate mentalization-based Families and Carers Training and Support, a supportive and skills-based program consisting of five 1.5- to 2-hr evening meetings, delivered by trained family members, or to delayed intervention']","['adverse incidents reported by the family member in relation to the person with BPD', 'adverse incidents', 'depression, total anxiety, and total burden', 'family functioning and well-being improved more in the immediate-treatment group; changes', 'self-reported family well-being, empowerment, burden, and levels of anxiety and depression']","[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}]","[{'cui': 'C4704687', 'cui_str': 'Mentalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",,0.0943501,Secondary outcome measures showed family functioning and well-being improved more in the immediate-treatment group; changes were maintained at follow-up.,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Bateman', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology.'}]",Personality disorders,['10.1037/per0000298']
677,31889382,Nd:YAG laser vs IPL in inflammatory and noninflammatory acne lesion treatment.,"BACKGROUND
Several topical and systemic therapies are available for the treatment of acne vulgaris but are associated with several limitations, and recently, intense pulse light (IPL) and long-pulsed 1064 nm Nd: YAG laser have shown efficacy.
AIMS
The current study aimed to compare the efficacy of Nd:YAG laser and IPL in inflammatory and noninflammatory acne lesions.
PATIENTS AND METHODS
Thirty patients with inflammatory and noninflammatory facial acne were assigned randomly and equally into two groups, the Nd:YAG and IPL groups. The patients received three sessions of laser 2 weeks apart, and the clinical improvement was assessed by the reduction in the number of lesions.
RESULTS
At baseline, the two groups showed a nonsignificant difference as regards total number (P = .476), inflammatory (P = .457), and noninflammatory lesions (P = .420). The improvement in total lesions was significant in the Nd:YAG Group but nonsignificant in the IPL Group (P < .001, P = .13, respectively). Three patients (20%) in the IPL Group showed exacerbation after the first and second sessions. One month after the last session, the difference in improvement between noninflammatory and inflammatory lesions showed a significant difference in the Nd:YAG Group (P = .017) and a nonsignificant difference in the IPL Group (P = .823). Nd:YAG, compared to the IPL Group, showed a significant difference as regards the improvement score in noninflammatory lesions (P = .0099) and a nonsignificant difference in inflammatory lesions (P = .4295).
CONCLUSION
The significant improvement in noninflammatory lesions and the absence of a significant flare-up of acne as seen among patients treated with IPL make Nd:YAG a better therapeutic modality for acne.",2020,"At baseline, the two groups showed a nonsignificant difference as regards total number (P = .476), inflammatory (P = .457), and noninflammatory lesions (P = .420).",['Thirty patients with inflammatory and noninflammatory facial acne'],"['IPL', 'Nd:YAG laser and IPL', 'YAG laser vs IPL']","['noninflammatory lesions', 'noninflammatory and inflammatory lesions', 'total lesions', 'regards total number', 'inflammatory lesions', 'improvement score in noninflammatory lesions']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C0702166', 'cui_str': 'Acne'}]","[{'cui': 'C0587723', 'cui_str': 'Lasers, Yttrium Aluminum Garnet'}]","[{'cui': 'C0442743', 'cui_str': 'Noninflammatory (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",30.0,0.0255221,"At baseline, the two groups showed a nonsignificant difference as regards total number (P = .476), inflammatory (P = .457), and noninflammatory lesions (P = .420).","[{'ForeName': 'Khaled Mohey El-Din', 'Initials': 'KME', 'LastName': 'Monib', 'Affiliation': 'Department of Dermatology and Andrology, Faculty of Medicine, Benha University, Benha, Egypt.'}, {'ForeName': 'Mohamed Saber', 'Initials': 'MS', 'LastName': 'Hussein', 'Affiliation': 'Department of Dermatology and Andrology, Faculty of Medicine, Benha University, Benha, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13278']
678,30720503,"Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial.","MINI: Question: Is the Fundamentals of Robotic Surgery (FRS) proficiency-based progression curriculum effective for teaching basic robotic surgery skills?
FINDINGS
In an international multi-institutional, multispecialty, blinded, randomized control trial, implementation of the FRS skills curriculum using various simulation platforms led to improved performance of surgical trainees on a transfer test compared with controls.Meaning: The FRS is an effective simulation-based course for training to proficiency on basic robotic surgery skills before surgeons apply those skills clinically.
OBJECTIVE
To demonstrate the noninferiority of the fundamentals of robotic surgery (FRS) skills curriculum over current training paradigms and identify an ideal training platform.
SUMMARY BACKGROUND DATA
There is currently no validated, uniformly accepted curriculum for training in robotic surgery skills.
METHODS
Single-blinded parallel-group randomized trial at 12 international American College of Surgeons (ACS) Accredited Education Institutes (AEI). Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016. Benchmarks (proficiency levels) on the 7 FRS Dome tasks were established based on expert performance. Participants were then randomly assigned to 4 training groups: Dome (n = 29), dV-Trainer (n = 30), and DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula. The primary outcome was participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test). Secondary outcomes included cognitive test scores, GEARS ratings, and robot familiarity checklist scores.
RESULTS
All groups demonstrated significant performance improvement after skills training (P < 0.01). Participating residents and fellows performed tasks faster (DOME and DVSS groups) and with fewer errors than controls (DOME group; P < 0.01). Inter-rater reliability was high for the checklist scores (0.82-0.97) but moderate for GEARS ratings (0.40-0.67).
CONCLUSIONS
We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test. We therefore argue for its implementation across training programs before surgeons apply these skills clinically.",2019,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"['FRS) Skills Curriculum', 'Thirty-three robotic surgery experts and 123 inexperienced surgical trainees were enrolled between April 2015 and November 2016', '12 international American College of Surgeons (ACS']","['MINI', 'Robotic Surgery', 'robotic surgery (FRS) skills curriculum', 'DVSS (n = 32) that trained to benchmarks and control (n = 32) that trained using locally available robotic skills curricula', 'FRS', 'dV-Trainer']","['GEARS ratings', 'cognitive test scores, GEARS ratings, and robot familiarity checklist scores', 'participant performance after training based on task errors and duration on 5 basic robotic tasks (knot tying, continuous suturing, cutting, dissection, and vessel coagulation) using an avian tissue model (transfer-test']","[{'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010478', 'cui_str': 'Curriculum'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0600269', 'cui_str': 'Familiarity'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0560032', 'cui_str': 'knot (qualifier value)'}, {'cui': 'C0453920', 'cui_str': 'Tie (physical object)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0005595', 'cui_str': 'Aves'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}]",,0.168174,We provide evidence of effectiveness for the FRS curriculum by demonstrating better performance of those trained following FRS compared with controls on a transfer test.,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': 'Department of Surgery, University of Washington Medical Center, Seattle, WA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': 'Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': 'Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': 'Department of Surgery, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery, St. Mary's Hospital, Imperial College, London, UK.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': 'Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT.'}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': 'Penn Medicine Clinical Simulation Center, Philadelphia, PA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': 'Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': 'Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': 'Lehigh Valley Health Network, Allentown, PA.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': 'Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': 'EndoCAS Simulation Center, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': 'Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.'}]",Annals of surgery,['10.1097/SLA.0000000000003220']
679,31687884,Can inpatient multidisciplinary rehabilitation improve health-related quality of life in MS patients on the long term - The Danish MS Hospitals Rehabilitation Study.,"BACKGROUND
Inpatient multidisciplinary rehabilitation (MDR) can improve health-related quality of life (HRQoL) in multiple sclerosis (MS) patients. However, the evidence of a long-term benefit is limited.
OBJECTIVES
To investigate the long-term effectiveness of inpatient MDR on HRQoL in MS patients.
METHODS
We conducted a randomized controlled partial crossover trial with 427 MS patients.
RESULTS
Statistical significant long-term improvements in HRQoL were found in three of the six outcome measures at 12-month follow-up. Three in four suggested minimal clinically important differences (MCIDs) were unmet.
CONCLUSION
These results indicate that the administration of inpatient MDR may lead to long-lasting improvements in HRQoL in MS patients.",2020,"RESULTS
Statistical significant long-term improvements in HRQoL were found in three of the six outcome measures at 12-month follow-up.","['multiple sclerosis (MS) patients', 'MS patients', '427 MS patients']",['Inpatient multidisciplinary rehabilitation (MDR'],"['HRQoL', 'health-related quality of life']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0594682,"RESULTS
Statistical significant long-term improvements in HRQoL were found in three of the six outcome measures at 12-month follow-up.","[{'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Boesen', 'Affiliation': 'The Danish MS Hospitals, Haslev, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nørgaard', 'Affiliation': 'The Danish MS Hospitals, Haslev, Denmark.'}, {'ForeName': 'Anders Guldhammer', 'Initials': 'AG', 'LastName': 'Skjerbæk', 'Affiliation': 'The Danish MS Hospitals, Haslev, Denmark.'}, {'ForeName': 'Peter Vestergaard', 'Initials': 'PV', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Petersen', 'Affiliation': 'Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Brita', 'Initials': 'B', 'LastName': 'Løvendahl', 'Affiliation': 'The Danish MS Hospitals, Haslev, Denmark.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Trénel', 'Affiliation': 'Danish Technological Institute, Aarhus, Denmark.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519884244']
680,29876247,Neuroplasticity of cognitive control networks following cognitive training for chronic traumatic brain injury.,"Cognitive control is the ability to coordinate thoughts and actions to achieve goals. Cognitive control impairments are one of the most persistent and devastating sequalae of traumatic brain injuries (TBI). There have been efforts to improve cognitive control in individuals with post-acute TBI. Several studies have reported changes in neuropsychological measures suggesting the efficacy of cognitive training in improving cognitive control. Yet, the neural substrates of improved cognitive control after training remains poorly understood. In the current study, we identified neural plasticity induced by cognitive control training for TBI using resting-state functional connectivity (rsFC). Fifty-six individuals with chronic mild TBI (9 years post-injury on average) were randomized into either a strategy-based cognitive training group (N = 26) or a knowledge-based training group (active control condition; N = 30) for 8 weeks. We acquired a total of 109 resting-state functional magnetic resonance imaging from 45 individuals before training, immediately post-training, and 3 months post-training. Relative to the controls, the strategy-based cognitive training group showed monotonic increases in connectivity in two cognitive control networks (i.e., cingulo-opercular and fronto-parietal networks) across time points in multiple brain regions ( p voxel < 0.001, p cluster < 0.05). Analyses of brain-behavior relationships revealed that fronto-parietal network connectivity over three time points within the strategy-based cognitive training group was positively associated with the trail making scores ( p voxel < 0.001, p cluster < 0.05). These findings suggest that training-induced neuroplasticity continues through chronic phases of TBI and that rsFC can serve as a neuroimaging biomarker of evaluating the efficacy of cognitive training for TBI.",2018,"Relative to the controls, the strategy-based cognitive training group showed monotonic increases in connectivity in two cognitive control networks (i.e., cingulo-opercular and fronto-parietal networks) across time points in multiple brain regions ( p voxel < 0.001, p cluster < 0.05).","['chronic traumatic brain injury', 'individuals with post-acute TBI', 'Fifty-six individuals with chronic mild TBI (9\u202fyears post-injury on average']","['cognitive control training for TBI using resting-state functional connectivity (rsFC', 'cognitive training', 'strategy-based cognitive training group (N\u202f=\u202f26) or a knowledge-based training group (active control condition; N\u202f=\u202f30) for 8\u202fweeks']","['fronto-parietal network connectivity', 'trail making scores']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022752', 'cui_str': 'Knowledge Bases'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",109.0,0.0141947,"Relative to the controls, the strategy-based cognitive training group showed monotonic increases in connectivity in two cognitive control networks (i.e., cingulo-opercular and fronto-parietal networks) across time points in multiple brain regions ( p voxel < 0.001, p cluster < 0.05).","[{'ForeName': 'Kihwan', 'Initials': 'K', 'LastName': 'Han', 'Affiliation': 'Center for BrainHealth®, School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, TX, USA. Electronic address: kihwan.han@utdallas.edu.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Chapman', 'Affiliation': 'Center for BrainHealth®, School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, TX, USA. Electronic address: schapman@utdallas.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Krawczyk', 'Affiliation': 'Center for BrainHealth®, School of Behavioral and Brain Sciences, The University of Texas at Dallas, Dallas, TX, USA; Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: daniel.krawczyk@utdallas.edu.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2018.01.030']
681,31790144,Dynamic Interactions Between LH and Testosterone in Healthy Community-Dwelling Men: Impact of Age and Body Composition.,"BACKGROUND
Aging is associated with diminished testosterone (Te) secretion, which may be attributed to Leydig cell dysfunction, decreased pituitary stimulation, and altered Te feedback.
OBJECTIVE
To study all regulatory nodes-gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and Leydig cell-in the same cohort of healthy men.
STUDY DESIGN
This was a placebo-controlled, blinded, prospectively randomized cross-over study in 40 men, age range 19 to 73 years, and body mass index (BMI) range 20 to 34.3 kg/m2. A submaximal dose of the GnRH antagonist ganirelix was used to assess outflow of GnRH, by calculating the difference between LH output during the control arm and ganirelix arm. Ketoconazole (a steroidogenic inhibitor) was used to estimate feedback, by the difference in LH output during the ketoconazole and control arm. High-dose ganirelix and repeated LH infusions were used to measure testicular responsivity. Blood sampling was performed at 10-minute intervals.
RESULTS
There were age-related, but not body composition-related decreases in estimated GnRH secretion, the feedback strength of Te on LH, and Leydig cell responsivity to LH, accompanied by changes in approximate entropy. Bioavailable Te levels were negatively related to both age and computed tomography (CT)-estimated abdominal visceral mass (AVF), without interaction between these variables. The LH response to a submaximal dose of GnRH was independent of age and AVF.
CONCLUSION
Advancing age is associated with (1) attenuated bioavailable Te secretion caused by diminished GnRH outflow and not by decreased GnRH responsivity of the gonadotrope, (2) diminished testicular responsivity to infused LH pulses, and (3) partial compensation by diminished Te feedback on central gonadotropic regulation.",2020,"Bioavailable Te levels were negatively related to both age and CT-estimated abdominal visceral mass (AVF), without interaction between these variables.","['Healthy Community-Dwelling Men', 'age range 19-73 yr, BMI range 20-34.3 kg/m2', 'healthy men', '40 men']","['placebo', 'Ketoconazole (steroidogenic inhibitor', 'LH and Testosterone', 'ketoconazole', 'ganirelix (GnRH antagonist']","['LH output', 'Bioavailable Te levels', 'LH response', 'testicular responsivity']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0686114,"Bioavailable Te levels were negatively related to both age and CT-estimated abdominal visceral mass (AVF), without interaction between these variables.","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Internal Medicine, Section Endocrinology and Metabolism, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Los Angeles, California.'}, {'ForeName': 'Paul Y', 'Initials': 'PY', 'LastName': 'Takahashi', 'Affiliation': 'Department of Primary Care Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo School of Graduate Medical Education, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgz246']
682,31687762,Efficacy and safety of edoxaban compared with warfarin according to the burden of diseases in patients with atrial fibrillation: insights from the ENGAGE AF-TIMI 48 trial.,"AIMS
Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs.
METHODS AND RESULTS
In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P < 0.05 for each). The annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI = 0, 1, 2, 3, or ≥4 were 5.9%, 8.7%, 6.6%, 10.3%, and 13.6% (Ptrend < 0.001). There were no significant interactions between treatment with HDER vs. warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction > 0.10 for each).
CONCLUSION
Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.",2020,"There were no significant interactions between treatment with HDER vs warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction >0.10 for each).
","['21,105 patients with AF followed for an average of 2.8 years', 'patients with atrial fibrillation (AF', 'Patients with Atrial Fibrillation']","['edoxaban regimen (HDER), a lower-dose edoxaban regimen (LDER), or warfarin', 'edoxaban', 'HDER vs warfarin', 'Warfarin', 'vitamin K antagonist oral anticoagulants', 'Edoxaban']","['thromboembolic events, bleeding, and death', 'safety, efficacy', 'efficacy, safety, and net outcomes', 'CCI scores', 'Efficacy and Safety', 'efficacy, safety', 'Updated Charlson Comorbidity Index (CCI', 'annualized rates of the primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) for CCI=0, 1, 2, 3 or\u2009≥\u20094']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index (assessment scale)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.0264034,"There were no significant interactions between treatment with HDER vs warfarin and efficacy, safety, and net outcomes across the CCI groups (P-interaction >0.10 for each).
","[{'ForeName': 'André M', 'Initials': 'AM', 'LastName': 'Nicolau', 'Affiliation': 'Escola Paulista de Medicina, Universidade Federal de São Paulo, Rua Botucatu, 720 São Paulo, Brazil.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Corbalan', 'Affiliation': 'Hospital Clinico Pontificia Universidad Catolica de Chile, Facultad de Medicina, Santiago, Chile.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Departamento de Cardiopneumologia, Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, São Paulo, Brazil.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Zierhut', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Medical Affairs Antithrombotic & Cardiovascular Therapeutic Area, Zielstattstraße 48, 81379 Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kerschnitzki', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Medical Affairs Antithrombotic & Cardiovascular Therapeutic Area, Zielstattstraße 48, 81379 Munich, Germany.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Duris', 'Affiliation': 'Fakultná nemocnica s poliklinikou, Nové Zámky, Slovakia.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Juul-Möller', 'Affiliation': 'Skåne University Hospital (SUS), Malmö, Sweden.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Voitk', 'Affiliation': 'Department of Invasive Cardiology, Center of Cardiology, North Estonia Medical Center Foundation, J. Sütiste tee 19, 13419 Tallinn, Estonia.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Trevisan', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Nordio', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Hale Building, Room 7022, 60 Fenwood Road, Boston, MA 02115, USA.""}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz061']
683,31682194,Mentalization-Based Treatment Versus Specialist Treatment as Usual for Borderline Personality Disorder: Economic Evaluation Alongside a Randomized Controlled Trial With 36-Month Follow-Up.,"The authors present an economic evaluation performed alongside a randomized controlled trial of mentalization-based treatment in a day hospital setting (MBT-DH) versus specialist treatment as usual (S-TAU) for borderline personality disorder (BPD) with a 36-month follow-up period. Ninety-five patients from two Dutch treatment institutes were randomly assigned. Societal costs were compared with the proportion of BPD remissions and quality-adjusted life years (QALYs) measured using the five-dimensional EuroQol instrument. The incremental societal costs for one additional QALY could not be calculated. The costs for one additional BPD remission with MBT-DH are approximately є29,000. There was a 58% likelihood that MBT-DH leads to more remitted patients at additional costs compared with S-TAU, and a 35% likelihood that MBT-DH leads to more remissions at lower costs. MBT-DH is not cost-effective compared with S-TAU with QALYs as the outcome, and slightly more cost-effective than S-TAU at 36 months with BPD symptoms as the outcome.",2019,"MBT-DH is not cost-effective compared with S-TAU with QALYs as the outcome, and slightly more cost-effective than S-TAU at 36 months with BPD symptoms as the outcome.","['borderline personality disorder (BPD) with a 36-month follow-up period', 'Ninety-five patients from two Dutch treatment institutes']","['Mentalization-Based Treatment Versus Specialist Treatment', 'mentalization-based treatment in a day hospital setting (MBT-DH) versus specialist treatment as usual (S-TAU']","['incremental societal costs', 'Societal costs', 'BPD remissions and quality-adjusted life years (QALYs']","[{'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C4704687', 'cui_str': 'Mentalization'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",95.0,0.0794276,"MBT-DH is not cost-effective compared with S-TAU with QALYs as the outcome, and slightly more cost-effective than S-TAU at 36 months with BPD symptoms as the outcome.","[{'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koppers', 'Affiliation': 'Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth M P', 'Initials': 'EMP', 'LastName': 'Laurenssen', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Peen', 'Affiliation': 'Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Maaike L', 'Initials': 'ML', 'LastName': 'Smits', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Luyten', 'Affiliation': 'Faculty of Psychology and Educational Sciences, University of Leuven, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busschbach', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Kamphuis', 'Affiliation': 'Department of Psychology, University of Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Kikkert', 'Affiliation': 'Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Jack J M', 'Initials': 'JJM', 'LastName': 'Dekker', 'Affiliation': 'Arkin Mental Health Care, Amsterdam, The Netherlands.'}]",Journal of personality disorders,['10.1521/pedi_2019_33_454']
684,31657454,Comparison of real costs in the French healthcare system in newly diagnosed patients with pemphigus for first-line treatment with rituximab vs. standard corticosteroid regimen: data from a national multicentre trial.,"BACKGROUND
Rituximab has been demonstrated to be highly effective as a first-line treatment for moderate-to-severe pemphigus; however, its high cost can be considered a limitation of this treatment.
OBJECTIVES
To compare direct costs of two regimens, rituximab + short-term prednisone vs. prednisone alone, tested in the Ritux3 trial.
METHODS
Patients were randomly assigned to receive 2 g of rituximab and two 500-mg maintenance infusions at month 12 and month 18 along with low doses of prednisone for 3-6 months, or high doses of prednisone alone tapered over 12-18 months. We estimated the direct costs related to (i) protocol (treatments, consultations, hospitalizations); (ii) unfavourable disease course (relapse); and (iii) adverse events in both treatment groups during a 3-year follow-up.
RESULTS
Annual individual cost discrepancies related to drugs decreased from +€3597 to -€1589 from the first to the third year, which corresponded to an initially higher cost in the rituximab group, counterbalanced during follow-up by costs related to treatment of patients with persistent disease activity/relapses in the standard corticosteroid (CS) group. Individual costs relating to treatment of adverse events were higher in the standard CS group (€4352) than in the rituximab group (€2468). Overall, mean individual total cost over the 3 years of follow-up was €13 997 in the standard CS arm vs. €14 818 in the rituximab arm, corresponding to a difference of €821 more per patient (+6%).
CONCLUSIONS
First-line treatment of pemphigus with rituximab results in a slightly greater cost compared with a standard CS regimen. What's already known about this topic Rituximab is the most effective treatment for moderate-to-severe pemphigus. Rituximab cost might be considered as a limitation of this treatment. What does this study add? After 3 years of follow-up, mean individual total cost for a patient with first-line treatment with rituximab was €14 818 vs. €13 997 with standard corticosteroids (CS), resulting in a slightly higher cost of €821 (+6%). The initially greater cost of rituximab was counterbalanced by costs related to management of flares/relapses in patients treated with a standard CS regimen.",2020,Individual costs relating to treatment of adverse events were higher in the standard CS group (€4352) than in the rituximab group (€2468).,"['Patients', 'newly diagnosed pemphigus patients']","['rituximab + short-term prednisone vs. prednisone', 'prednisone', 'rituximab', 'rituximab versus standard corticosteroid regimen']","['mean individual total cost', 'direct costs related to (i) protocol (treatments, consultations, hospitalizations); (ii) unfavourable disease course (relapse); and (iii) adverse events', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030807', 'cui_str': 'Pemphigus'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",821.0,0.0367292,Individual costs relating to treatment of adverse events were higher in the standard CS group (€4352) than in the rituximab group (€2468).,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hébert', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vermeulin', 'Affiliation': 'Department of Biostatistics and Clinical Research, INSERM U 1219, Rouen University Hospital, University of Rouen, Rouen, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tanguy', 'Affiliation': 'Department of Biostatistics and Clinical Research, INSERM U 1219, Rouen University Hospital, University of Rouen, Rouen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tedbirt', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mignard', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bénichou', 'Affiliation': 'Department of Biostatistics and Clinical Research, INSERM U 1219, Rouen University Hospital, University of Rouen, Rouen, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}]",The British journal of dermatology,['10.1111/bjd.18563']
685,30081012,"The Relationship Between Optic Disc Volume, Area, and Frisén Score in Patients With Idiopathic Intracranial Hypertension.","PURPOSE
To compare measurements of papilledema using fundus photography, optical coherence tomography (OCT), and Frisén score in patients with idiopathic intracranial hypertension (IIH).
DESIGN
Retrospective, noncomparative analysis of randomized controlled trial data.
METHODS
The Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) evaluated weight management and treatment with acetazolamide compared with placebo in patients with IIH and mild visual loss. Among the 126 subjects in the IIHTT OCT substudy, fundus photographs and OCT scans of the optic disc were taken at baseline and at 6 and 12 months after enrollment. Trained readers scored each eye using a modified Frisén scale and measured the area of disc elevation. OCT scans assessed optic nerve head (ONH) volume. Correlations between volume and area were computed for both study and nonstudy eyes.
RESULTS
Disc area and ONH volume were positively correlated at baseline (R 2 = 0.77 in study eyes, P < .001). Correlations between area and volume were similar in the treatment groups at baseline, but were weaker in the acetazolamide group compared with the placebo group at 6 months (R 2 = 0.25 vs R 2 = 0.76 in study eyes) and 12 months (R 2 = 0.19 vs R 2 = 0.65 in study eyes). At 6 and 12 months after enrollment, there was no consistent relationship between Frisén score, disc area, and ONH volumes in the acetazolamide group.
CONCLUSION
Frisén score fails to reflect the photographic area and OCT volume of papilledema after treatment with acetazolamide. Clinicians should use caution when using the Frisén scale to monitor the effect of treatment on papilledema over time.",2018,"Correlations between area and volume were similar in the treatment groups at baseline, but were weaker in the acetazolamide group compared with the placebo group at 6 months (R 2 = 0.25 vs R 2 = 0.76 in study eyes) and 12 months (R 2 = 0.19 vs R 2 = 0.65 in study eyes).","['Patients With Idiopathic Intracranial Hypertension', 'patients with IIH and mild visual loss', '126 subjects in the IIHTT OCT substudy', 'patients with idiopathic intracranial hypertension (IIH']","['acetazolamide', 'papilledema using fundus photography, optical coherence tomography (OCT', 'placebo']","['fundus photographs and OCT scans of the optic disc', 'Optic Disc Volume, Area, and Frisén Score', 'photographic area and OCT volume of papilledema', 'Frisén score, disc area, and ONH volumes', 'OCT scans assessed optic nerve head (ONH) volume', 'Disc area and ONH volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033845', 'cui_str': 'Idiopathic Intracranial Hypertension'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0030353', 'cui_str': 'Optic Disk Edema'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography (procedure)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0227817', 'cui_str': 'Uterine Fundus'}, {'cui': 'C0441633'}, {'cui': 'C0029127', 'cui_str': 'Optic Nerve Head'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030353', 'cui_str': 'Optic Disk Edema'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}]",126.0,0.116667,"Correlations between area and volume were similar in the treatment groups at baseline, but were weaker in the acetazolamide group compared with the placebo group at 6 months (R 2 = 0.25 vs R 2 = 0.76 in study eyes) and 12 months (R 2 = 0.19 vs R 2 = 0.65 in study eyes).","[{'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Sheils', 'Affiliation': 'University of Rochester School of Medicine & Dentistry, Rochester, New York, USA; Department of Ophthalmology, David & Ilene Flaum Eye Institute, Rochester, New York, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Fischer', 'Affiliation': 'University of Rochester School of Medicine & Dentistry, Rochester, New York, USA; Department of Ophthalmology, David & Ilene Flaum Eye Institute, Rochester, New York, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Hollar', 'Affiliation': 'University of Rochester School of Medicine & Dentistry, Rochester, New York, USA; Department of Ophthalmology, David & Ilene Flaum Eye Institute, Rochester, New York, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Blanchard', 'Affiliation': 'University of Rochester School of Medicine & Dentistry, Rochester, New York, USA; Department of Ophthalmology, David & Ilene Flaum Eye Institute, Rochester, New York, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Feldon', 'Affiliation': 'University of Rochester School of Medicine & Dentistry, Rochester, New York, USA; Department of Ophthalmology, David & Ilene Flaum Eye Institute, Rochester, New York, USA. Electronic address: Steven_Feldon@URMC.rochester.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2018.07.032']
686,31567725,Extended Prophylaxis With Nevirapine Does Not Affect Growth in HIV-Exposed Infants.,"BACKGROUND
Effects of prolonged nevirapine prophylaxis exposure on growth among HIV-exposed uninfected (HEU) infants are unknown. This study examines the impact of extended nevirapine prophylaxis from 6 weeks to 6 months on the growth of HEU infants followed for 18 months and also identifies correlates of incident wasting, stunting, underweight, and low head circumference in the HPTN 046 trial.
METHODS
Intention-to-treat analysis examined the effect of extended nevirapine exposure on: weight-for-age Z-score, length-for-age Z-score, weight-for-length Z-score, and head circumference-for-age Z-score. Multivariable linear mixed-effects and Cox proportional hazard models were used to compare growth outcomes between the study arms and identify correlates of incident adverse growth outcomes, respectively.
RESULTS
Compared to placebo, extended prophylactic nevirapine given daily from 6 weeks to 6 months did not affect growth in HEU breastfeeding (BF) infants over time (treatment × time: P > 0.05). However, overall growth declined over time (time effect: P < 0.01) when compared with WHO general population norms. Male sex was associated with higher risk of all adverse growth outcomes (P < 0.05), whereas short BF duration was associated with wasting (P = 0.03). Maternal antiretroviral therapy exposure was protective against underweight (P = 0.02). Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (P < 0.05).
CONCLUSIONS
It is reassuring that prolonged exposure to nevirapine for prevention-of-mother-to-child HIV transmission does not restrict growth. However, targeted interventions are needed to improve growth outcomes among at-risk HEU infants (i.e., male sex, short BF duration, lack of maternal antiretroviral therapy exposure, and resident in Zimbabwe).",2019,"Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (p<.05).
","['HEU infants followed for 18 months and also identifies correlates of incident wasting, stunting, underweight, and low head circumference in the HPTN 046 trial']","['extended nevirapine', 'nevirapine', 'nevirapine prophylaxis', 'nevirapine prophylaxis exposure', 'placebo, extended prophylactic nevirapine', 'Zimbabwe']","[' weight-for-age Z-score (WAZ), length-for-age Z-score (LAZ), weight-for-length Z-score (WLZ) and head circumference-for-age (HCZ', 'overall growth', 'short BF duration']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}]","[{'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.0927972,"Zimbabwe tended to have worse growth outcomes especially stunting, compared to South Africa, Uganda and Tanzania (p<.05).
","[{'ForeName': 'Carolyne', 'Initials': 'C', 'LastName': 'Onyango-Makumbi', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda.'}, {'ForeName': 'Arthur H', 'Initials': 'AH', 'LastName': 'Owora', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration/MU-JHU CARE LTD, Kampala, Uganda.'}, {'ForeName': 'Ramadhani S', 'Initials': 'RS', 'LastName': 'Mwiru', 'Affiliation': 'Division of Global HIV/AIDS, Center for Global Health, U.S. Centers for Disease Control and Prevention, Dar es Salaam, Tanzania.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mwatha', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Young', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Department of Obstetrics and Gynaecology, Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Hoosen M', 'Initials': 'HM', 'LastName': 'Coovadia', 'Affiliation': 'Maternal Adolescent and Child Health (MatCH), University of the Witwatersrand, South Africa.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Stranix-Chibanda', 'Affiliation': 'College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Manji', 'Affiliation': 'Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Maldonado', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Stanford University, School of Medicine, Stanford, CA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore,MD.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Andrew', 'Affiliation': 'Family Health International, Durham, NC.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Family Health International, Durham, NC.'}, {'ForeName': 'Wafaie', 'Initials': 'W', 'LastName': 'Fawzi', 'Affiliation': 'Departments of Global Health and Population, Nutrition and Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins Medical Institutions, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002145']
687,31568799,Novel UL97 drug resistance mutations identified at baseline in a clinical trial of maribavir for resistant or refractory cytomegalovirus infection.,"In a Phase 2 clinical trial, 120 subjects with cytomegalovirus (CMV) infection refractory or resistant to standard therapy were randomized equally to 3 doses of oral maribavir treatment, and 70% achieved undetectable plasma CMV DNA within 12 weeks. At study entry, standard diagnostic UL97 genotyping was available for 71 subjects, with 60 (85%) revealing well-characterized ganciclovir resistance mutations that did not preclude a therapeutic response to maribavir. Central laboratory testing of a range of UL97 codons (288-468) not fully covered by standard genotyping was done on 93 subjects at baseline. This detected no previously known maribavir resistance mutations, but identified atypical mutations in 3 subjects, including a P-loop substitution F342Y, and ATP-binding region substitutions K359E/Q. By recombinant phenotyping, K359E and K359Q each conferred a nearly 4-fold increased ganciclovir 50% inhibitory concentration (EC50) without maribavir resistance, whereas F342Y conferred a 6-fold increased ganciclovir EC50 and a 4.5-fold increased maribavir EC50. The subject with F342Y detected at baseline did not achieve plasma CMV DNA clearance after 12 weeks of maribavir therapy and later developed an additional UL97 substitution H411Y known to confer 12- to 20-fold increased MBV EC50 by itself. The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold. Diagnostic genotyping of UL97 should be expanded to cover the ATP-binding region beginning at codon 335 to enable the detection of atypical resistance mutations and further correlation of their clinical significance.",2019,The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold.,"['71 subjects, with 60 (85%) revealing well-characterized ganciclovir resistance mutations that did not preclude a therapeutic response to maribavir', '120 subjects with cytomegalovirus (CMV) infection refractory or resistant to standard therapy']",['UL97 codons'],"['MBV EC50', 'maribavir EC50', 'plasma CMV DNA clearance']","[{'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0017066', 'cui_str': 'Ganciclovir'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009221', 'cui_str': 'Codon'}]","[{'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",120.0,0.0455351,The combination of F342Y and H411Y was shown to increase the maribavir EC50 by 56-fold.,"[{'ForeName': 'Sunwen', 'Initials': 'S', 'LastName': 'Chou', 'Affiliation': 'Division of Infectious Diseases, Oregon Health and Science University, Department of Veterans Affairs Medical Center, Portland, Oregon, USA. Electronic address: chous@ohsu.edu.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}, {'ForeName': 'Kening', 'Initials': 'K', 'LastName': 'Song', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}, {'ForeName': 'Tien', 'Initials': 'T', 'LastName': 'Bo', 'Affiliation': 'Shire, a Takeda Company, Lexington, MA, USA.'}]",Antiviral research,['10.1016/j.antiviral.2019.104616']
688,29560311,Altered network hub connectivity after acute LSD administration.,"LSD is an ambiguous substance, said to mimic psychosis and to improve mental health in people suffering from anxiety and depression. Little is known about the neuronal correlates of altered states of consciousness induced by this substance. Limited previous studies indicated profound changes in functional connectivity of resting state networks after the administration of LSD. The current investigation attempts to replicate and extend those findings in an independent sample. In a double-blind, randomized, cross-over study, 100 μg LSD and placebo were orally administered to 20 healthy participants. Resting state brain activity was assessed by functional magnetic resonance imaging. Within -network and between -network connectivity measures of ten established resting state networks were compared between drug conditions. Complementary analysis were conducted using resting state networks as sources in seed-to-voxel analyses. Acute LSD administration significantly decreased functional connectivity within visual, sensorimotor and auditory networks and the default mode network. While between -network connectivity was widely increased and all investigated networks were affected to some extent, seed-to-voxel analyses consistently indicated increased connectivity between networks and subcortical (thalamus, striatum) and cortical (precuneus, anterior cingulate cortex) hub structures. These latter observations are consistent with findings on the importance of hubs in psychopathological states, especially in psychosis, and could underlay therapeutic effects of hallucinogens as proposed by a recent model.",2018,"Acute LSD administration significantly decreased functional connectivity within visual, sensorimotor and auditory networks and the default mode network.","['20 healthy participants', 'people suffering from anxiety and depression']","['LSD', 'LSD and placebo']","['functional connectivity within visual, sensorimotor and auditory networks', 'connectivity between networks and subcortical (thalamus, striatum) and cortical (precuneus, anterior cingulate cortex) hub structures', 'Resting state brain activity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}]",20.0,0.0922605,"Acute LSD administration significantly decreased functional connectivity within visual, sensorimotor and auditory networks and the default mode network.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'University of Basel, Department of Psychiatry (UPK), Basel 4012, Switzerland.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Dolder', 'Affiliation': 'University of Basel, Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, Basel 4031, Switzerland.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'University of Basel, Department of Psychiatry (UPK), Basel 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'University of Basel, Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, Basel 4031, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'University of Basel, Department of Psychiatry (UPK), Basel 4012, Switzerland. Electronic address: stefan.borgwardt@upkbs.ch.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2018.03.005']
689,31672505,Eighteen-Year Follow-Up Study of 2 Alternative Bearing Surfaces Used in Total Hip Arthroplasty in the Same Young Patients.,"BACKGROUND
This study compares the long-term functional, radiographic, and computed tomography scan outcomes and implant survivorship of ceramic-on-ceramic total hip arthroplasty (C-O-C THA) and ceramic-on-highly cross-linked polyethylene total hip arthroplasty (C-O-HXLPE THA) in the same patients.
METHODS
In this randomized, prospective trial conducted between January 1999 and April 2003, 133 patients (266 hips) younger than 55 years were enrolled. Each patient received C-O-C THA in 1 hip and a C-O-HXLPE THA in the other. The mean follow-up was 17.1 years (range, 15-18 years); there were 84 men and 49 women with a mean age of 53 ± 7 years (range, 25-55 years).
RESULTS
At the latest follow-up, mean Harris hip scores (94 vs 93 points; P = .861), pain scores (43 vs 42 points; P = .651), and patient satisfaction scores (7.8 vs 7.6 points; P = .379) were not different between the 2 groups. Eight hips (3%) in the C-O-C THA had an audible squeaking sound. The mean annual penetration rate of HXLPE was 0.0162 ± 0.032 mm per year. No osteolysis was recorded on radiographs or computed tomography scans in either group. At 17.1 years, the survival rate of the acetabular component was 97% in the C-O-C bearing group and 98% in the C-O-HXLPE bearing group (P = .923). The survival rate of the femoral component was 99% in both groups.
CONCLUSION
Both C-O-C THA and C-O-HXLPE THA functioned well, with no osteolysis at mean of 17.1-year follow-up.",2020,"At the latest follow-up, mean Harris hip scores (94 vs 93 points; P = .861), pain scores (43 vs 42 points; P = .651), and patient satisfaction scores (7.8 vs 7.6 points; P = .379) were not different between the 2 groups.","['Same Young Patients', 'same patients', 'January 1999 and April 2003, 133 patients (266 hips) younger than 55 years were enrolled', 'The mean follow-up was 17.1 years (range, 15-18 years); there were 84 men and 49 women with a mean age of 53 ± 7 years (range, 25-55 years']","['C-O-C THA', 'C-O-C THA and C-O-HXLPE']","['pain scores', 'survival rate of the femoral component', 'patient satisfaction scores', 'survival rate of the acetabular component', 'mean Harris hip scores', 'mean annual penetration rate of HXLPE', 'No osteolysis', 'Total Hip Arthroplasty']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score (assessment scale)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0221204', 'cui_str': 'Osteolysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}]",84.0,0.0256149,"At the latest follow-up, mean Harris hip scores (94 vs 93 points; P = .861), pain scores (43 vs 42 points; P = .651), and patient satisfaction scores (7.8 vs 7.6 points; P = .379) were not different between the 2 groups.","[{'ForeName': 'Young-Hoo', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'The Joint Replacement Center, Seoul Metropolitan SeoNam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jang-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'The Joint Replacement Center, Ewha Womans University Ewha Seoul Hospital, Seoul, Republic of Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.09.051']
690,29527475,An acute bout of aerobic or strength exercise specifically modifies circulating exerkine levels and neurocognitive functions in elderly individuals with mild cognitive impairment.,"Although exercise is an effective way to decrease the risk of developing Alzheimer's disease, the biological basis for such benefits from the different exercise modes remains elusive. The present study thus aimed (i) to investigate the effects of acute aerobic or resistance exercise on neurocognitive performances and molecular markers when performing a cognitive task involving executive functioning in older adults with amnestic mild cognitive impairment (aMCI), and (ii) to explore relationships of acute exercise-induced neurocognitive changes with changes in circulating levels of neuroprotective growth factors (e.g., BDNF, IGF-1, VEGF, and FGF-2, collectively termed 'exerkines'), elicited by different acute exercise modes. Sixty-six older adults with aMCI were recruited and randomly assigned to an aerobic exercise (AE) group, a resistance exercise (RE) group, or a non-exercise-intervention (control) group. The behavioral [i.e., accuracy rate (AR) and reaction time (RT)] and electrophysiological [i.e., event-related potential (ERP) P3 latency and amplitude collected from the Fz, Cz, and Pz electrodes] indices were simultaneously measured when participants performed a Flanker task at baseline and after either an acute bout of 30 min of moderate-intensity AE, RE or a control period. Blood samples were taken at three time points, one at baseline (T1) and two after an acute exercise intervention (T2 and T3: before and after cognitive task test, respectively). The results showed that the acute AE and RE not only improved behavioral (i.e., RTs) performance but also increased the ERP P3 amplitudes in the older adults with aMCI. Serum FGF-2 levels did not change with acute aerobic or resistance exercise. However, an acute bout of aerobic exercise significantly increased serum levels of BDNF and IGF-1 and tended to increase serum levels of VEGF in elderly aMCI individuals. Acute resistance exercise increased only serum IGF-1 levels. However, the exercise-induced elevated levels of these molecular markers returned almost to baseline levels in T3 (about 20 min after acute exercise). In addition, changes in the levels of neurotrophic and angiogenic factors were not correlated with changes in RTs and P3 amplitudes. The present findings of changes in neuroprotective growth factors and neurocognitive performances through acute AE or RE suggest that molecular and neural prerequisites for exercise-dependent plasticity are preserved in elderly aMCI individuals. However, the distinct pattern of changes in circulating molecular biomarkers induced by two different exercise modes in aMCI elderly individuals and the potentially interactive mechanisms of the effects of BDNF, IGF-1, and VEGF on amyloid-β provide a basis for future long-term exercise intervention to investigate whether AE relative to RE might be more effective in prevention/treatment of an early stage neurodegenerative disease.",2018,"In addition, changes in the levels of neurotrophic and angiogenic factors were not correlated with changes in RTs and P3 amplitudes.","['older adults with amnestic mild cognitive impairment (aMCI', 'elderly individuals with mild cognitive impairment', 'elderly aMCI individuals', 'older adults with aMCI', 'Sixty-six older adults with aMCI', 'aMCI elderly individuals']","['acute aerobic or resistance exercise', 'aerobic exercise (AE) group, a resistance exercise (RE) group, or a non-exercise-intervention (control) group', 'Acute resistance exercise', 'aerobic or strength exercise']","['serum levels of VEGF', 'ERP P3 amplitudes', 'behavioral [i.e., accuracy rate (AR) and reaction time (RT)] and electrophysiological [i.e., event-related potential (ERP) P3 latency and amplitude collected from the Fz, Cz, and Pz electrodes] indices', 'serum IGF-1 levels', 'serum levels of BDNF and IGF-1', 'levels of neurotrophic and angiogenic factors', 'behavioral (i.e., RTs) performance', 'RTs and P3 amplitudes', 'Serum FGF-2 levels']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517841', 'cui_str': 'Sixty-six'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0337380', 'cui_str': 'Endoscopic retrograde pancreatography (procedure)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C4704801', 'cui_str': 'Neurotrophic'}, {'cui': 'C0002976', 'cui_str': 'Angiogenesis Factor'}, {'cui': 'C0380603', 'cui_str': 'Prostate Epithelial Cell Growth Factor'}]",66.0,0.0610951,"In addition, changes in the levels of neurotrophic and angiogenic factors were not correlated with changes in RTs and P3 amplitudes.","[{'ForeName': 'Chia-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Institute of Physical Education, Health and Leisure Studies, National Cheng Kung University, No. 1, University Road, Tainan, 701, Taiwan, ROC.. Electronic address: andytsai@mail.ncku.edu.tw.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Institute of Experimental Endocrinology, Biomedical Research Center, Slovak Academy of Sciences, Dubravska cesta 9, 84505 Bratislava, Slovakia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ukropcová', 'Affiliation': 'Institute of Experimental Endocrinology, Biomedical Research Center, Slovak Academy of Sciences, Dubravska cesta 9, 84505 Bratislava, Slovakia; Institute of Pathological Physiology, Faculty of Medicine, Comenius University, Bratislava, Slovakia; Faculty of Physical Education and Sports, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'Ming-Chyi', 'Initials': 'MC', 'LastName': 'Pai', 'Affiliation': ""Division of Behavioral Neurology, Department of Neurology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, No.138, Sheng Li Road, Tainan 704, Taiwan, ROC.; Alzheimer's Disease Research Center, National Cheng Kung University Hospital, Taiwan. Electronic address: pair@mail.ncku.edu.tw.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2017.10.028']
691,31676127,"Re: Brian I. Rini, Thomas Powles, Michael B. Atkins, et al. Atezolizumab plus Bevacizumab Versus Sunitinib in Patients with Previously Untreated Metastatic Renal Cell Carcinoma (IMmotion151): A Multicentre, Open-label, Phase 3, Randomised Controlled Trial. Lancet 2019;393:2404-15: Putting IMmotion into Motion: Personalizing Frontline Treatment for Metastatic Renal Cell Carcinoma.",,2020,,"['Patients with Previously Untreated Metastatic Renal Cell Carcinoma (IMmotion151', 'Metastatic Renal Cell Carcinoma']","['Atezolizumab plus Bevacizumab Versus Sunitinib', 'Lancet 2019;393:2404-15: Putting IMmotion into Motion: Personalizing Frontline Treatment']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0777169', 'cui_str': 'Lancet (physical object)'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0293768,,"[{'ForeName': 'Nirmish', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Urology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. Electronic address: singlan@mskcc.org.'}]",European urology,['10.1016/j.eururo.2019.09.015']
692,31672793,Varying Association of Extended Hours Dialysis with Quality of Life.,"BACKGROUND AND OBJECTIVES
Little is known about the effect of changes in dialysis hours on patient-reported outcome measures. We report the effect of doubling dialysis hours on a range of patient-reported outcome measures in a randomized trial, overall and separately for important subgroups.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
The A Clinical Trial of IntensiVE Dialysis trial randomized 200 participants to extended or standard weekly hours hemodialysis for 12 months. Patient-reported outcome measures included two health utility scores (EuroQOL-5 Dimensions-3 Level, Short Form-6 Dimension) and their derived quality-adjusted life year estimates, two generic health scores (Short Form-36 Physical Component Summary, Mental Component Summary), and a disease-specific score (Kidney Disease Component Score). Outcomes were assessed as the mean difference from baseline using linear mixed effects models adjusted for time point and baseline score, with interaction terms added for subgroup analyses. Prespecified subgroups were dialysis location (home- versus institution-based), dialysis vintage (≤6 months versus >6 months), region (China versus Australia, New Zealand, Canada), and baseline score (lowest, middle, highest tertile). Multiplicity-adjusted P values (Holm-Bonferroni) were calculated for the main analyses.
RESULTS
Extended dialysis hours was associated with improvement in Short Form-6 Dimension (mean difference, 0.027; 95% confidence interval [95% CI], 0.00 to 0.05; P =0.03) which was not significant after adjustment for multiple comparisons ( P adjusted =0.05). There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09; P =0.2; P adjusted =0.2) or in quality-adjusted life years. There were small positive differences in generic and disease-specific quality of life: Physical Component Summary (mean difference, 2.3; 95% CI, 0.6 to 4.1; P =0.01; P adjusted =0.04), Mental Component Summary (mean difference, 2.5; 95% CI, 0.5 to 4.6; P =0.02; P adjusted =0.05) and Kidney Disease Component Score (mean difference, 3.5; 95% CI, 1.5 to 5.5; P =0.001; P adjusted =0.005). The results did not differ among predefined subgroups or by baseline score.
CONCLUSIONS
The effect of extended hours hemodialysis on patient-reported outcome measures reached statistical significance in some but not all measures. Within each measure the effect was consistent across predefined subgroups. The clinical importance of these differences is unclear.",2019,"There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09; P =0.2; P adjusted =0.2) or in quality-adjusted life years.",['200 participants to extended or standard weekly hours hemodialysis for 12 months'],[],"['generic and disease-specific quality of life: Physical Component Summary', 'Kidney Disease Component Score', 'health utility scores (EuroQOL-5 Dimensions-3 Level, Short Form-6 Dimension) and their derived quality-adjusted life year estimates, two generic health scores (Short Form-36 Physical Component Summary, Mental Component Summary), and a disease-specific score (Kidney Disease Component Score', 'Mental Component Summary', 'EuroQOL-5 Dimensions-3 Level health utility', 'Short Form-6 Dimension']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205448', 'cui_str': 'Two'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",200.0,0.449499,"There were no significant differences in EuroQOL-5 Dimensions-3 Level health utility (mean difference, 0.036; 95% CI, -0.02 to 0.09; P =0.2; P adjusted =0.2) or in quality-adjusted life years.","[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'van den Broek-Best', 'Affiliation': 'Department of Medicine, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': ""Renal Department, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Howard', 'Affiliation': 'Sydney School of Public Health University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Renal Department, Sunshine Coast University Hospital, Birtinya, Australia.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'Renal Services, North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, First Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jinsheng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Nephrology, Fourth Hospital Affiliated to Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, Australia; and.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, University of New South Wales Sydney, Sydney, Australia; mjardine@georgeinstitute.org.au.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.06800619']
693,31656094,"Genetic Susceptibility, Dietary Protein Intake, and Changes of Blood Pressure: The POUNDS Lost Trial.","High blood pressure (BP) is closely related to obesity, and weight loss lowers BP. Evidence has shown considerable interpersonal variation of changes in BP among people experiencing weight loss, and such variation might be partly determined by genetic factors. We assessed the changes in systolic and diastolic BP (SBP/DBP) among 692 participants randomly assigned to 1 of 4 diets varying in macronutrient content for 2 years. Two separate polygenic scores (SBP/DBP-PGS derived from 52/50 single nucleotide polymorphisms) were built for each participant based on 66 BP-associated single nucleotide polymorphisms. During a 2-year intervention, participants in the bottom versus upper tertile of SBP/DBP-PGS had a greater decrease in SBP (△SBP at 6, 12, and 24 months: -3.84 versus -1.61, -4.76 versus -2.75, -2.49 versus -1.63; P =0.001) or in DBP (△DBP at 6, 12, and 24 months: -3.09 versus -1.34, -2.69 versus -1.44, -1.82 versus -0.53; P <0.001). We also found gene-diet interaction on changes in SBP from baseline to 24 months ( P interaction =0.009). Among participants assigned to a high-protein diet, those with a lower SBP-polygenic scores had greater decreases in SBP at months 6 ( P =0.018), months 12 ( P =0.007), and months 24 ( P =0.089); while no significant difference was observed across the SBP-polygenic scores tertile groups among those assigned to an average-protein diet (all P values >0.05). Our data indicate that genetic susceptibility may affect BP changes in response to weight-loss diet interventions, and protein intake may modify the genetic associations with changes in BP. This trial was registered at URL: http://www.clinicaltrials.gov. Unique identifier: NCT00072995.",2019,We also found gene-diet interaction on changes in SBP from baseline to 24 months ( P interaction =0.009).,['692 participants randomly assigned to 1 of 4 diets varying in macronutrient content for 2 years'],[],"['SBP (△SBP', 'systolic and diastolic BP (SBP/DBP', 'SBP-polygenic scores', 'Genetic Susceptibility, Dietary Protein Intake, and Changes of Blood Pressure', 'SBP', 'High blood pressure (BP']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0314657', 'cui_str': 'Genetic Susceptibility'}, {'cui': 'C0425424', 'cui_str': 'Dietary protein intake (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}]",692.0,0.0165496,We also found gene-diet interaction on changes in SBP from baseline to 24 months ( P interaction =0.009).,"[{'ForeName': 'Dianjianyi', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA (G.A.B.).'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA (F.M.S., L.Q.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'From the Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA (D.S., T.Z., X.L., Y.H., Z.L., L.Q.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13510']
694,29499855,"Dose-Related Target Occupancy and Effects on Circuitry, Behavior, and Neuroplasticity of the Glycine Transporter-1 Inhibitor PF-03463275 in Healthy and Schizophrenia Subjects.","BACKGROUND
Glycine transporter-1 (GlyT1) inhibitors may ameliorate cognitive impairments associated with schizophrenia. The dose-related occupancy and target engagement of the GlyT1 inhibitor PF-03463275 were studied to inform optimal dose selection for a clinical trial for cognitive impairments associated with schizophrenia.
METHODS
In substudy 1, the effects of PF-03463275 (10, 20, and 40 mg twice a day) on occupancy of GlyT1 were tested using positron emission tomography and 18 F-MK-6577, and visual long-term potentiation (LTP) in schizophrenia patients (SZs) and healthy control subjects. Furthermore, the capacity of PF-03463275 to attenuate ketamine-induced disruption of working memory-related activation of a ""working memory"" circuit was tested only in healthy control subjects using functional magnetic resonance imaging. Subsequently, the effects of PF-03463275 (60 mg twice a day) on occupancy of GlyT1 and long-term potentiation were examined only in SZs (substudy 2).
RESULTS
PF-03463275 at 10, 20, 40, and 60 mg twice a day produced ∼44%, 61%, 76%, and 83% GlyT1 occupancy, respectively, in SZs with higher ligand binding to GlyT1 in subcortical versus cortical regions. PF-03463275 did not attenuate any ketamine-induced effects but did improve working memory accuracy in healthy control subjects. PF-03463275 increased long-term potentiation only in SZs with peak effects at 40 mg twice a day (∼75% GlyT1 occupancy) and with a profile suggestive of an inverted U dose response. PF-03463275 was well-tolerated.
CONCLUSIONS
The dose-related GlyT1 occupancy of PF-03463275 is linear. While PF-03463275 did not show evidence of facilitating N-methyl-D-aspartate receptor function in the ketamine assay, it enhanced neuroplasticity in SZs. These findings provide support for a clinical trial to test the ability of PF-03463275 to enhance cognitive remediation toward addressing cognitive impairments associated with schizophrenia.",2018,PF-03463275 did not attenuate any ketamine-induced effects but did improve working memory accuracy in healthy control subjects.,"['healthy control subjects', 'Healthy and Schizophrenia Subjects', 'schizophrenia patients (SZs) and healthy control subjects']","['Glycine transporter-1 ', 'positron emission tomography and 18 F-MK-6577, and visual long-term potentiation (LTP', 'PF-03463275']","['PF-03463275 increased long-term potentiation', 'tolerated', 'Circuitry, Behavior, and Neuroplasticity', 'occupancy of GlyT1 and long-term potentiation', 'working memory accuracy']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0285409', 'cui_str': 'Glycine Transporter 1'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C4045681', 'cui_str': '(18F)MK-6577'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C2934445', 'cui_str': 'PF-03463275'}]","[{'cui': 'C2934445', 'cui_str': 'PF-03463275'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0027880', 'cui_str': 'Neural Plasticity'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}]",,0.0467825,PF-03463275 did not attenuate any ketamine-induced effects but did improve working memory accuracy in healthy control subjects.,"[{'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, Connecticut; Mental Health Service Line, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut. Electronic address: deepak.dsouza@yale.edu.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Carson', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale University School of Medicine, New Haven, Connecticut; Department of Biomedical Engineering, Yale University, New Haven, Connecticut; Yale Positron Emission Tomography Center, New Haven, Connecticut.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Driesen', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut; Mental Health Service Line, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Johannesen', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut; Mental Health Service Line, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, Connecticut; Mental Health Service Line, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut; Department of Neurobiology, Yale University School of Medicine, New Haven, Connecticut; Abraham Ribicoff Research Facilities, Connecticut Mental Health Center, New Haven, Connecticut; Yale-New Haven Hospital, New Haven, Connecticut; Mental Health Service Line, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Biological psychiatry,['10.1016/j.biopsych.2017.12.019']
695,30592439,Effects of Assistive Home Technology on quality of life and falls of people with dementia and job satisfaction of caregivers: Results from a pilot randomized controlled trial.,"OBJECTIVES
Determine the effects of the implementation of Assistive Home Technology (AHT) in group homes on the quality of life (QoL) of people with dementia and on job satisfaction of caregivers.
METHOD
Pilot randomized controlled trial in nine in-patient care group homes (group homes with vs. without AHT). Participants were 54 people with dementia and 25 professionals. Outcome measurements were QoL, fall incidents, needs, use of restraints, job satisfaction, workload, and general health.
RESULTS
Living in a group home with AHT had a positive effect on four QoL domains: 'social isolation', 'having things to do', 'esthetics', and 'quality of life appreciation'. No effects were found on 12 other QoL domains. Fall incidents during bathroom visits were significantly reduced by the application of AHT. During this implementation phase, in the AHT group home, a moderate negative effect was found on caregiver's appreciation of work circumstances. No effects on other outcome measures were found.
CONCLUSION
Positive effects were found on aspects of QoL and fall incidents in the bathroom. The lower caregiver appreciation of work circumstances in the AHT group confirms the importance of intensive support and guidance of personnel during the implementation of AHT.",2020,"RESULTS
Living in a group home with AHT had a positive effect on four QoL domains: 'social isolation', 'having things to do', 'esthetics', and 'quality of life appreciation'.","['people with dementia and job satisfaction of caregivers', 'Participants were 54 people with dementia and 25 professionals', 'group homes on the quality of life (QoL) of people with dementia and on job satisfaction of caregivers', 'nine in-patient care group homes (group homes with vs. without AHT']","['Assistive Home Technology', 'Assistive Home Technology (AHT']","[""QoL domains: 'social isolation', 'having things to do', 'esthetics', and 'quality of life appreciation"", 'QoL, fall incidents, needs, use of restraints, job satisfaction, workload, and general health', 'quality of life and falls']","[{'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0034380'}, {'cui': 'C0017313'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0034380'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",54.0,0.0787314,"RESULTS
Living in a group home with AHT had a positive effect on four QoL domains: 'social isolation', 'having things to do', 'esthetics', and 'quality of life appreciation'.","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Lauriks', 'Affiliation': 'Amsterdam Public Health Service (GGD Amsterdam), Department of Epidemiology, Health promotion and Care innovation, Amsterdam , The Netherlands.'}, {'ForeName': 'Franka', 'Initials': 'F', 'LastName': 'Meiland', 'Affiliation': 'Amsterdam University Medical Centers, location VUmc, Department of Psychiatry, Amsterdam Public Health Research Institute , Amsterdam, The Netherlands.'}, {'ForeName': 'Johan P', 'Initials': 'JP', 'LastName': 'Osté', 'Affiliation': 'Amsterdam Public Health Service (GGD Amsterdam), Department of Epidemiology, Health promotion and Care innovation, Amsterdam , The Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Hertogh', 'Affiliation': 'Amsterdam University Medical Centers, location VUmc, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute , Amsterdam, The Netherlands.'}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Dröes', 'Affiliation': 'Amsterdam University Medical Centers, location VUmc, Department of Psychiatry, Amsterdam Public Health Research Institute , Amsterdam, The Netherlands.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2018.1531952']
696,30326768,"Impact of a Nurse-Led Health Promotion Intervention in an Aging Population: Results From a Quasi-Experimental Study on the ""Community Health Consultation Offices for Seniors"".","Objective: The study evaluated the nurse-led intervention "" Community Health Consultation Offices for Seniors (CHCO) "" on health-related and care needs-related outcomes in community-dwelling older people (⩾60 years). Method: With a quasi-experimental design, the CHCO intervention was evaluated on health-related and care needs-related outcomes after 1-year follow-up. Older people who received the intervention were frail, overweight, or were smoking. The comparison group received care as usual. In both groups, similar data were collected on health status, falls and fractures, and care needs. In the intervention group, additional data were collected on biometric measures and health-related behavior. Results: The intervention group and the care-as-usual group included 403 seniors and 984 seniors, respectively. Health-related outcomes, behaviors, and biometric measures, remained stable. After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group. Discussion: The CHCO intervention showed no significant improvement on health-related outcomes or stability in care needs-related outcomes.",2020,"After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.
","['With a quasi-experimental design', 'Community Health Consultation Offices for Seniors', 'Aging Population', 'Older people who received the intervention were frail, overweight, or were smoking', 'nurse-led intervention "" Community Health Consultation Offices for Seniors (CHCO)"" on health-related and care needs-related outcomes in community-dwelling older people (⩾60 years']","['CHCO intervention', 'Nurse-Led Health Promotion Intervention']","['biometric measures and health-related behavior', 'Health-related outcomes, behaviors, and biometric measures']","[{'cui': 'C0015320', 'cui_str': 'Experimental Design'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0254728,"After 1 year, care needs increased for both groups, but at a lower rate for the care-as-usual group.
","[{'ForeName': 'Anne Esther', 'Initials': 'AE', 'LastName': 'Marcus-Varwijk', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Innovating with Older Adults, Zwolle, The Netherlands.'}, {'ForeName': 'Lilian L', 'Initials': 'LL', 'LastName': 'Peters', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of General Practice & Elderly Care Medicine, The Netherlands.'}, {'ForeName': 'Tommy L S', 'Initials': 'TLS', 'LastName': 'Visscher', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Healthy Cities, Zwolle, The Netherlands.'}, {'ForeName': 'Carolien H M', 'Initials': 'CHM', 'LastName': 'Smits', 'Affiliation': 'Windesheim University of Applied Sciences, Research Group Innovating with Older Adults, Zwolle, The Netherlands.'}, {'ForeName': 'Adelita V', 'Initials': 'AV', 'LastName': 'Ranchor', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Health Psychology Section, The Netherlands.'}, {'ForeName': 'Joris P J', 'Initials': 'JPJ', 'LastName': 'Slaets', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department Internal Medicine, the Netherlands.'}]",Journal of aging and health,['10.1177/0898264318804946']
697,29079458,Bilateral extracephalic transcranial direct current stimulation improves endurance performance in healthy individuals.,"BACKGROUND
Transcranial direct current stimulation (tDCS) has been used to enhance endurance performance but its precise mechanisms and effects remain unknown.
OBJECTIVE
To investigate the effect of bilateral tDCS on neuromuscular function and performance during a cycling time to task failure (TTF) test.
METHODS
Twelve participants in randomized order received a placebo tDCS (SHAM) or real tDCS with two cathodes (CATHODAL) or two anodes (ANODAL) over bilateral motor cortices and the opposite electrode pair over the ipsilateral shoulders. Each session lasted 10 min and current was set at 2 mA. Neuromuscular assessment was performed before and after tDCS and was followed by a cycling time to task failure (TTF) test. Heart rate (HR), ratings of perceived exertion (RPE), leg muscle pain (PAIN) and blood lactate accumulation (ΔB[La - ]) in response to the cycling TTF test were measured.
RESULTS
Corticospinal excitability increased in the ANODAL condition (P < 0.001) while none of the other neuromuscular parameters showed any change. Neuromuscular parameters did not change in the SHAM and CATHODAL conditions. TTF was significantly longer in the ANODAL (P = 0.003) compared to CATHODAL and SHAM conditions (12.61 ± 4.65 min; 10.61 ± 4.34 min; 10.21 ± 3.47 min respectively), with significantly lower RPE and higher ΔB[La - ] (P < 0.001). No differences between conditions were found for HR (P = 0.803) and PAIN during the cycling TTF test (P = 0.305).
CONCLUSION
Our findings demonstrate that tDCS with the anode over both motor cortices using a bilateral extracephalic reference improves endurance performance.",2018,"No differences between conditions were found for HR (P = 0.803) and PAIN during the cycling TTF test (P = 0.305).
","['Twelve participants in randomized order received a', 'healthy individuals']","['Bilateral extracephalic transcranial direct current stimulation', 'Transcranial direct current stimulation (tDCS', 'bilateral tDCS', 'placebo tDCS (SHAM) or real tDCS with two cathodes (CATHODAL) or two anodes (ANODAL) over bilateral motor cortices and the opposite electrode pair over the ipsilateral shoulders']","['Neuromuscular parameters', 'Heart rate (HR), ratings of perceived exertion (RPE), leg muscle pain (PAIN) and blood lactate accumulation (ΔB[La - ]) in response to the cycling TTF test', 'PAIN', 'Corticospinal excitability', 'endurance performance', 'TTF', 'neuromuscular function and performance']","[{'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0031843', 'cui_str': 'function'}]",12.0,0.264416,"No differences between conditions were found for HR (P = 0.803) and PAIN during the cycling TTF test (P = 0.305).
","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Angius', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham Maritime, UK.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Mauger', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham Maritime, UK. Electronic address: l.mauger@kent.ac.uk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hopker', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham Maritime, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Berenson-Allen Center for Non-Invasive Brain Stimulation, Division of Cognitive Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA; Institut Universitari de Neurorehabilitacio Guttmann, Badalona, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Santarnecchi', 'Affiliation': 'Berenson-Allen Center for Non-Invasive Brain Stimulation, Division of Cognitive Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Marcora', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham Maritime, UK.'}]",Brain stimulation,['10.1016/j.brs.2017.09.017']
698,29672097,Cognitive and affective mechanisms of pain and fatigue in multiple sclerosis.,"OBJECTIVE
To examine the extent to which pain catastrophizing, fatigue catastrophizing, positive affect, and negative affect simultaneously mediated the associations between common symptoms of multiple sclerosis (MS; i.e., pain, fatigue) and impact on daily life, depressive symptoms, and resilience.
METHOD
Participants were community-dwelling adults with MS (N = 163) reporting chronic pain, fatigue, and/or moderate depressive symptoms. Multiple mediation path analysis was used to model potential mediators of pain and fatigue separately, using baseline data from a randomized controlled trial comparing two symptom self-management interventions.
RESULTS
In the pain model, pain catastrophizing was a mediator of pain intensity with pain interference and depression. Negative affect was a mediator of pain intensity with depression and resilience. In the fatigue model, fatigue catastrophizing was a mediator of fatigue intensity with fatigue impact and depression. Positive affect was a mediator of fatigue intensity with depression and resilience.
CONCLUSIONS
These findings provide preliminary support for the presence of differential effects of cognitive-affective mediators and suggest potential targets for psychological interventions based on an individual's clinical presentation. The differential mediating effects also support the inclusion of both positive and negative aspects of psychological health in models of pain and fatigue, which would not be otherwise apparent if negative constructs were examined in isolation. To our knowledge, this is the first study to utilize a multivariate path analysis approach to examine cognitive-affective mediators of pain and fatigue in MS, while also examining positive and negative constructs concurrently. (PsycINFO Database Record",2018,"Positive affect was a mediator of fatigue intensity with depression and resilience.
","['Participants were community-dwelling adults with MS (N = 163) reporting chronic pain, fatigue, and/or moderate depressive symptoms', 'pain and fatigue in multiple sclerosis']",[],"['pain intensity with depression and resilience', 'pain, fatigue) and impact on daily life, depressive symptoms, and resilience', 'fatigue intensity with depression and resilience']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]",[],"[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",163.0,0.040987,"Positive affect was a mediator of fatigue intensity with depression and resilience.
","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Arewasikporn', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine.'}, {'ForeName': 'Aaron P', 'Initials': 'AP', 'LastName': 'Turner', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Alschuler', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine.'}, {'ForeName': 'Abbey J', 'Initials': 'AJ', 'LastName': 'Hughes', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington School of Medicine.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000611']
699,30024203,Promoting resilience in individuals aging with multiple sclerosis: Results from a pilot randomized controlled trial.,"PURPOSE/OBJECTIVE
Starting in middle adulthood, individuals living with multiple sclerosis (MS) are confronted with the simultaneous challenge of coping with advancing MS alongside age-related changes. Psychological resilience is thought to play an important role in promoting healthy aging and thus may be important in the context of aging with MS. This study aimed to evaluate whether Everyday Matters, a novel positive psychology program, had a positive effect on resilience and other related outcomes in adults with MS relative to a wait-list control group. Research Method/Design: This was a single-center two-group pilot randomized (1:1) controlled trial comparing the Everyday Matters intervention to a waitlist control. Randomized participants were N = 31 adults with MS aged ≥ 45 years. The 6-week program, developed by the National MS Society, was delivered via group teleconference and supplemented with readings, videos, and online participation. Participants in both groups completed outcome assessments measuring resilience, satisfaction with social roles, mood, pain, fatigue, and sleep at baseline and posttreatment.
RESULTS
Analyses on N = 27 participants who completed study assessments revealed a significant group effect for resilience and satisfaction with social roles, and trend differences for positive affect and well-being and depressive symptom severity. At posttreatment, participants in the intervention group reported the group to be very helpful, found the telephone-based delivery convenient, and felt the benefits of participating outweighed the effort.
CONCLUSIONS/IMPLICATIONS
These results suggest that the Everyday Matters program shows promise for increasing resilience in adults with MS and that a full-scale randomized controlled trial is warranted. (PsycINFO Database Record",2018,"Participants in both groups completed outcome assessments measuring resilience, satisfaction with social roles, mood, pain, fatigue, and sleep at baseline and posttreatment.
","['adults with MS', 'middle adulthood, individuals living with multiple sclerosis (MS', 'individuals aging with multiple sclerosis', 'adults with MS relative to a wait-list control group', 'Randomized participants were N = 31 adults with MS aged ≥ 45 years']",['Everyday Matters intervention'],"['resilience, satisfaction with social roles, mood, pain, fatigue, and sleep at baseline and posttreatment', 'positive affect and well-being and depressive symptom severity', 'resilience and satisfaction with social roles']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",31.0,0.116588,"Participants in both groups completed outcome assessments measuring resilience, satisfaction with social roles, mood, pain, fatigue, and sleep at baseline and posttreatment.
","[{'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Alschuler', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Arewasikporn', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Ian K', 'Initials': 'IK', 'LastName': 'Nelson', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Ivan R', 'Initials': 'IR', 'LastName': 'Molton', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine.'}]",Rehabilitation psychology,['10.1037/rep0000223']
700,31668138,"Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: Results from the iStep-MS randomised controlled trial.","BACKGROUND
There is limited information regarding the safety, feasibility and acceptability of behaviour-change interventions to increase physical activity (PA) and reduce sedentary behaviour among people with multiple sclerosis (MS). Prior to evaluating efficacy, it is important to identify problems with feasibility and acceptability, which may undermine effectiveness.
OBJECTIVE
To examine the safety, feasibility and acceptability of a behaviour-change intervention to increase PA and reduce sedentary behaviour among people with MS.
METHODS
Sixty people received a 3-month intervention or usual care. Fatigue, pain and adverse events (AEs) were assessed. Feasibility and acceptability were explored through focus groups with physiotherapists and interviews with participants. Fidelity to intervention content, delivery skills, programme receipt and programme task were assessed.
RESULTS
There was no difference in AE rate between groups ( p = 0.965). Fatigue and pain were not higher in the intervention group at 3 or 9 months. Therapists reported the intervention was feasible to deliver and fidelity was acceptable. Twenty-nine participants (97%) attended at least 75% of sessions. Participants found the intervention acceptable but suggested some amendments were required to intervention components.
CONCLUSIONS
The intervention was safe, feasible and acceptable. Although modifications are required to intervention components, the intervention warrants further evaluation in a future trial.",2020,Fatigue and pain were not higher in the intervention group at 3 or 9 months.,"['people with multiple sclerosis (MS', 'people with multiple sclerosis', 'Sixty people received a', 'people with MS']","['behaviour-change intervention', '3-month intervention or usual care']","['safety, feasibility and acceptability', 'Fatigue, pain and adverse events (AEs', 'Fatigue and pain', 'Safety, feasibility, acceptability and effects', 'sedentary behaviour', 'AE rate', 'physical activity behaviour', 'Feasibility and acceptability', 'Fidelity to intervention content, delivery skills, programme receipt and programme task']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",29.0,0.0715056,Fatigue and pain were not higher in the intervention group at 3 or 9 months.,"[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Ryan', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK/Department of Epidemiology and Public Health Medicine, Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fortune', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Stennett', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Cherry', 'Initials': 'C', 'LastName': 'Kilbride', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lavelle', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hendrie', 'Affiliation': 'MS Therapy Centre, Norwich, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'DeSouza', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Abdul', 'Affiliation': 'The Berkshire MS Therapy Centre, Reading, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Brewin', 'Affiliation': 'Health Economics Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'David', 'Affiliation': 'Health Economics Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Anokye', 'Affiliation': '10 Minute CBT, Letchworth Garden City, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Victor', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}, {'ForeName': 'Meriel', 'Initials': 'M', 'LastName': 'Norris', 'Affiliation': 'Ageing Studies Theme, Institute of Environment, Health and Societies, Brunel University London, London, UK.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519886231']
701,31522922,Health Center-Based Community-Supported Agriculture: An RCT.,"INTRODUCTION
Socioeconomically vulnerable individuals often face poor access to nutritious food and bear a disproportionate burden of diet-related chronic illness. This study tested whether a subsidized community-supported agriculture intervention could improve diet quality.
STUDY DESIGN
An RCT was conducted from May 2017 to December 2018 (data analyzed in 2019).
SETTING/PARTICIPANTS
Adults with a BMI >25 kg/m 2 seen at a community health center in central Massachusetts, or who lived in the surrounding county, were eligible.
INTERVENTION
Individuals were randomized to receive either subsidized community-supported agriculture membership (which provided a weekly farm produce pickup from June to November) or healthy eating information (control group). For equity, the control group received financial incentives similar to the intervention group.
MAIN OUTCOME MEASURES
The primary outcome was the Healthy Eating Index 2010 total score (range, 0-100; higher indicates better diet quality; minimum clinically meaningful difference, 3). Healthy Eating Index was assessed using 3 24-hour recalls per participant collected each growing season. Intention-to-treat analyses compared Healthy Eating Index scores between the intervention and control group, accounting for repeated measures with generalized estimating equations.
RESULTS
There were 128 participants enrolled and 122 participants for analysis. The participants' mean age was 50.3 (SD=13.6) years; 82% were women; and 88% were white, non-Hispanic, with a similar distribution of baseline characteristics comparing the intervention and control groups. Baseline Healthy Eating Index total score was 53.9 (SD=15.3) in the control group and 55.1 (SD=15.2) in the intervention group (p=0.68). The intervention increased the mean Healthy Eating Index total score relative to the control group (4.3 points higher, 95% CI=0.5, 8.1, p=0.03). Food insecurity was lower in the intervention group (RR=0.68, 95% CI=0.48, 0.96).
CONCLUSIONS
A community-supported agriculture intervention resulted in clinically meaningful improvements in diet quality. Subsidized community-supported agriculture may be an important intervention for vulnerable individuals.
TRIAL REGISTRATION
This study is registered at www.clinicaltrials.gov NCT03231592.
SUPPLEMENT INFORMATION
This article is part of a supplement entitled Identifying and Intervening on Social Needs in Clinical Settings: Evidence and Evidence Gaps, which is sponsored by the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services, Kaiser Permanente, and the Robert Wood Johnson Foundation.",2019,"Food insecurity was lower in the intervention group (RR=0.68, 95% CI=0.48, 0.96).
","['Adults with a BMI >25 kg/m 2 seen at a community health center in central Massachusetts, or who lived in the surrounding county, were eligible', '128 participants enrolled and 122 participants for analysis', '2017 to December 2018 (data analyzed in 2019', ""participants' mean age was 50.3 (SD=13.6) years; 82% were women; and 88% were white, non-Hispanic, with a similar distribution of baseline characteristics comparing the intervention and control groups""]","['Health Center-Based Community-Supported Agriculture', 'subsidized community-supported agriculture intervention', 'subsidized community-supported agriculture membership (which provided a weekly farm produce pickup from June to November) or healthy eating information (control group']","['Healthy Eating Index', 'Food insecurity', 'Healthy Eating Index scores', 'mean Healthy Eating Index total score relative', 'Healthy Eating Index 2010 total score', 'Baseline Healthy Eating Index total score', 'diet quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0001829', 'cui_str': 'Farming'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0557759', 'cui_str': 'Farmland'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C3494174', 'cui_str': 'Food Insecurity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",128.0,0.145764,"Food insecurity was lower in the intervention group (RR=0.68, 95% CI=0.48, 0.96).
","[{'ForeName': 'Seth A', 'Initials': 'SA', 'LastName': 'Berkowitz', 'Affiliation': 'Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina; Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. Electronic address: seth_berkowitz@med.unc.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': ""O'Neill"", 'Affiliation': 'Just Roots, Greenfield, Massachusetts.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Sayer', 'Affiliation': 'Community Health Center of Franklin County, Greenfield, Massachusetts.'}, {'ForeName': 'Naysha N', 'Initials': 'NN', 'LastName': 'Shahid', 'Affiliation': 'Division of General Internal Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Maegan', 'Initials': 'M', 'LastName': 'Petrie', 'Affiliation': 'Community Health Center of Franklin County, Greenfield, Massachusetts.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Schouboe', 'Affiliation': 'Just Roots, Greenfield, Massachusetts; TerraCorps, Lowell, Massachusetts.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Saraceno', 'Affiliation': 'Just Roots, Greenfield, Massachusetts; TerraCorps, Lowell, Massachusetts.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bellin', 'Affiliation': 'Just Roots, Greenfield, Massachusetts.'}]",American journal of preventive medicine,['10.1016/j.amepre.2019.07.015']
702,30384780,Experiences of patients with stroke and their caregivers with caregiver-mediated exercises during the CARE4STROKE trial.,"Purpose: Caregiver-mediated exercises are a novel way of delivering augmented exercise therapy for patients with stroke, in which patients do additional therapeutic exercises together with a caregiver. This explorative qualitative study is part of the CARE4STROKE trial and focused on how participants manage these exercises together. The research questions were: (1) how do the patient-caregiver couples exercise together? and (2) what does exercising together bring about, besides more hours of practice? Methods: Semi-structured interviews were conducted with patients and caregivers who participated in the CARE4STROKE intervention. Inductive thematic data analysis was applied. Results: Seven patients and seven caregivers were interviewed. Three different role-dynamics were found during caregiver-mediated exercises: (1) patient in control, (2) in concert, and (3) the caregiver as informal carer. In addition, three themes were identified about what exercising together brings about: (a) tailor-made exercises through active involvement, (b) preparation for the home situation, and (c) opportunity to be involved. Conclusion: Different role-dynamics are at play in caregiver-mediated exercises, and it is important for participating staff to be aware of their possible effects on the strain of patient or caregiver. Caregiver-mediated exercises were found to enhance individualization of the treatment plan and preparation for home discharge.Implications for rehabilitationCaregiver-mediated exercises, in which a caregiver does exercises with a patient, are currently under investigation as a new form of augmented exercise delivery after strokeDoing exercises together seems to make patient and caregivers actively involved in rehabilitation, which they appreciate, and which seems to help them prepare for the home situationCaregiver selection and monitoring role-dynamics during exercising is an important task of the rehabilitation team.",2020,"Three different role-dynamics were found during caregiver-mediated exercises: (1) patient in control, (2) in concert, and (3) the caregiver as informal carer.","['Semi-structured interviews were conducted with patients and caregivers who participated in the CARE4STROKE intervention', 'patients with stroke', 'patients with stroke and their caregivers with caregiver-mediated exercises during the CARE4STROKE trial', 'Seven patients and seven caregivers']",['exercise therapy'],[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]",[],7.0,0.0401541,"Three different role-dynamics were found during caregiver-mediated exercises: (1) patient in control, (2) in concert, and (3) the caregiver as informal carer.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Vloothuis', 'Affiliation': 'Amsterdam Rehabilitation Research Centre | Reade, Amsterdam, The Netherlands.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Depla', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Hertogh', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Kwakkel', 'Affiliation': 'Amsterdam Rehabilitation Research Centre | Reade, Amsterdam, The Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'van Wegen', 'Affiliation': 'Department of Rehabilitation Medicine, Amsterdam Movement Sciences, VU University Medical Center, Amsterdam, The Netherlands.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1507048']
703,29708388,Does exercise aid smoking cessation through reductions in anxiety sensitivity and dysphoria?,"OBJECTIVE
Research shows that high anxiety sensitivity (AS) and dysphoria are related to poor smoking cessation outcomes. Engaging in exercise may contribute to improvement in smoking cessation outcomes through reductions in AS and dysphoria. In the current study, we examined whether exercise can aid smoking cessation through reductions in AS and dysphoria.
METHOD
Participants were sedentary and low activity adult daily smokers (N = 136) with elevated AS who participated in a randomized controlled trial comparing smoking cessation treatment (ST) plus an exercise intervention (ST + EX) to ST plus wellness education (ST + CTRL). Self-reported smoking status was assessed in-person weekly from baseline through week 16 (end of-treatment; EOT), at week 22 (4 months postquit day), and at week 30 (6 months postquit day), and verified biochemically.
RESULTS
Results indicated that both AS and dysphoria at 6-month follow-up were significantly lower in the ST + EX group compared to the ST + CTRL group (controlling for baseline levels). Moreover, reductions in AS and dysphoria emerged as independent mechanisms of action explaining success in quitting.
CONCLUSIONS
These novel findings offer clinically significant evidence suggesting that vigorous-intensity exercise can effectively engage affective constructs in the context of smoking cessation. (PsycINFO Database Record",2018,"RESULTS
Results indicated that both AS and dysphoria at 6-month follow-up were significantly lower in the ST + EX group compared to the ST + CTRL group (controlling for baseline levels).",['Participants were sedentary and low activity adult daily smokers (N = 136) with elevated AS who participated'],"['ST + CTRL', 'smoking cessation treatment (ST) plus an exercise intervention (ST + EX) to ST plus wellness education (ST + CTRL', 'ST + EX', 'exercise aid smoking cessation']","['dysphoria', 'Self-reported smoking status']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0233477', 'cui_str': 'Dysphoric mood (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",136.0,0.0175593,"RESULTS
Results indicated that both AS and dysphoria at 6-month follow-up were significantly lower in the ST + EX group compared to the ST + CTRL group (controlling for baseline levels).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University.'}, {'ForeName': 'Lorra', 'Initials': 'L', 'LastName': 'Garey', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'Brooke Y', 'Initials': 'BY', 'LastName': 'Kauffman', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'Langdon', 'Affiliation': 'Department of Psychiatry, Rhode Island Hospital.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Powers', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Otto', 'Affiliation': 'Department of Psychology, Boston University.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Family Medicine and Public Health, University of California at San Diego.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Church', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University.'}, {'ForeName': 'Georita M', 'Initials': 'GM', 'LastName': 'Frierson', 'Affiliation': 'Department of Psychology, Howard University.'}, {'ForeName': 'Lindsey B', 'Initials': 'LB', 'LastName': 'Hopkins', 'Affiliation': 'Stress and Health Research Program, San Francisco VA Medical Center.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychology, University of Houston.'}, {'ForeName': 'Scarlett O', 'Initials': 'SO', 'LastName': 'Baird', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}, {'ForeName': 'Jasper A J', 'Initials': 'JAJ', 'LastName': 'Smits', 'Affiliation': 'Department of Psychology, The University of Texas at Austin.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000588']
704,30072213,"BKV, CMV, and EBV Interactions and their Effect on Graft Function One Year Post-Renal Transplantation: Results from a Large Multi-Centre Study.","BACKGROUND
BK virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr virus (EBV) reactivations are common after kidney transplantation and associated with increased morbidity and mortality. Although CMV might be a risk factor for BKV and EBV, the effects of combined reactivations remain unknown. The purpose of this study is to ascertain the interaction and effects on graft function of these reactivations.
METHODS
3715 serum samples from 540 kidney transplant recipients were analysed for viral load by qPCR. Measurements were performed throughout eight visits during the first post-transplantation year. Clinical characteristics, including graft function (GFR), were collected in parallel.
FINDINGS
BKV had the highest prevalence and viral loads. BKV or CMV viral loads over 10,000 copies·mL -1 led to significant GFR impairment. 57 patients had BKV-CMV combined reactivation, both reactivations were significantly associated (p = 0.005). Combined reactivation was associated with a significant GFR reduction one year post-transplantation of 11.7 mL·min -1 ·1.73 m -2 (p = 0.02) at relatively low thresholds (BKV > 1000 and CMV > 4000 copies·mL -1 ). For EBV, a significant association was found with CMV reactivation (p = 0.02), but no GFR reduction was found. Long cold ischaemia times were a further risk factor for high CMV load.
INTERPRETATION
BKV-CMV combined reactivation has a deep impact on renal function one year post-transplantation and therefore most likely on long-term allograft function, even at low viral loads. Frequent viral monitoring and subsequent interventions for low BKV and/or CMV viraemia levels and/or long cold ischaemia time are recommended. FUND: Investigator Initiated Trial; financial support by German Federal Ministry of Education and Research (BMBF).",2018,Combined reactivation was associated with a significant GFR reduction one year post-transplantation of 11.7 mL·min -1 ·1.73 m -2 (p = 0.02) at relatively low thresholds (BKV > 1000 and CMV > 4000 copies·mL -1 ).,"['3715 serum samples from 540 kidney transplant recipients were analysed for viral load by qPCR', 'FUND']","['BK virus (BKV), Cytomegalovirus (CMV) and Epstein-Barr virus']","['BKV-CMV combined reactivation, both reactivations', 'BKV, CMV, and EBV Interactions', 'morbidity and mortality', 'GFR reduction', 'graft function (GFR', 'CMV reactivation', 'BKV or CMV viral loads', 'Graft Function']","[{'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0016820', 'cui_str': 'Funds'}]","[{'cui': 'C0005670', 'cui_str': 'Polyomavirus hominis 1'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",,0.0190386,Combined reactivation was associated with a significant GFR reduction one year post-transplantation of 11.7 mL·min -1 ·1.73 m -2 (p = 0.02) at relatively low thresholds (BKV > 1000 and CMV > 4000 copies·mL -1 ).,"[{'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Blazquez-Navarro', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany; Systems Immunology Lab, Department of Biology, Humboldt-Universität zu Berlin, Philippstr. 13, 10115 Berlin, Germany.'}, {'ForeName': 'Chantip', 'Initials': 'C', 'LastName': 'Dang-Heine', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wittenbrink', 'Affiliation': 'Systems Immunology Lab, Department of Biology, Humboldt-Universität zu Berlin, Philippstr. 13, 10115 Berlin, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bauer', 'Affiliation': 'MicroDiscovery GmbH, Marienburger Str. 1, 10405 Berlin, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Wolk', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany; Psoriasis Research and Treatment Center, Institute of Medical Immunology, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Sabat', 'Affiliation': 'Psoriasis Research and Treatment Center, Institute of Medical Immunology, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany; Interdisciplinary Group of Molecular Immunopathology, Institute of Medical Immunology, Department of Dermatology and Allergy, Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.'}, {'ForeName': 'Timm H', 'Initials': 'TH', 'LastName': 'Westhoff', 'Affiliation': 'Medical Department 1, Universitätsklinikum der Ruhr-Universität Bochum, Ruhr-Universität Bochum, Hölkeskampring 40, 44625 Herne, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Sawitzki', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany; Molecular Immune Modulation, Institute for Medical Immunology, Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Reinke', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany; Berlin Center for Advanced Therapies (BeCAT), Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Thomusch', 'Affiliation': 'Klinik für Allgemein- und Viszeralchirurgie, Universitätsklinikum Freiburg, Hugstetter Straße 55, 79106 Freiburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hugo', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus, Medizinische Klinik III - Bereich Nephrologie, Fetscherstraße 74, 01307 Dresden, Germany.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Or-Guil', 'Affiliation': 'Systems Immunology Lab, Department of Biology, Humboldt-Universität zu Berlin, Philippstr. 13, 10115 Berlin, Germany. Electronic address: m.orguil@biologie.hu-berlin.de.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Babel', 'Affiliation': 'Berlin-Brandenburg Center for Regenerative Therapies (BCRT), Charité-Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany; Medical Department 1, Universitätsklinikum der Ruhr-Universität Bochum, Ruhr-Universität Bochum, Hölkeskampring 40, 44625 Herne, Germany. Electronic address: nina.babel@charite.de.'}]",EBioMedicine,['10.1016/j.ebiom.2018.07.017']
705,30121453,Targeting myeloid-derived suppressor cells using all-trans retinoic acid in melanoma patients treated with Ipilimumab.,"BACKGROUND
Immune checkpoint inhibitors have improved overall survival rates for many cancers, yet the majority of patients do not respond to treatment and succumb to disease progression. One tumor-related mechanism limiting the efficacy of immunotherapies in melanoma is the recruitment and expansion of myeloid-derived suppressor cells (MDSCs). Therefore, targeting MDSCs in combination with immunotherapies is an attractive strategy to improve response rates and effectiveness.
METHODS
We tested this strategy by designing a randomized phase II clinical trial treating advanced melanoma patients with either Ipilimumab monotherapy or Ipilimumab plus all-trans retinoic acid (ATRA). Clinicaltrails.gov identifier (NCT02403778). The frequency of circulating MDSCs and the activation of CD8(+) T cells was measured by flow cytometry. Expression of immunosuppressive genes was measured with quantitative real time-PCR. T cell suppressive functions were measured by mixed lymphocyte reaction.
RESULTS
Here we show that in vitro treatment with ATRA decreases immunosuppressive function of MDSCs in mixed lymphocyte reactions. Additionally, ATRA reduces the expression of immunosuppressive genes including PD-L1, IL-10, and indoleamine 2,3‑dioxygenase by MDSCs. Furthermore, the addition of ATRA to standard of care Ipilimumab therapy appears safe, as ATRA did not increase the frequency of grade 3 or 4 adverse events. Finally, ATRA significantly decreased the frequency of circulating MDSCs compared to Ipilimumab treatment alone in advanced-stage melanoma patients.
CONCLUSIONS
These results illustrate the importance of MDSCs in immunotherapy resistance and provide evidence that targeting MDSCs in cancer patients may augment immunotherapeutic approaches.",2018,"Additionally, ATRA reduces the expression of immunosuppressive genes including PD-L1, IL-10, and indoleamine 2,3‑dioxygenase by MDSCs.","['cancer patients', 'advanced melanoma patients with either']","['Ipilimumab', 'ATRA', 'Ipilimumab monotherapy or Ipilimumab plus all-trans retinoic acid (ATRA']","['Expression of immunosuppressive genes', 'expression of immunosuppressive genes including PD-L1, IL-10, and indoleamine 2,3‑dioxygenase by MDSCs', 'response rates and effectiveness', 'overall survival rates', 'T cell suppressive functions', 'frequency of circulating MDSCs and the activation of CD8(+) T cells', 'frequency of circulating MDSCs']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}]",,0.321918,"Additionally, ATRA reduces the expression of immunosuppressive genes including PD-L1, IL-10, and indoleamine 2,3‑dioxygenase by MDSCs.","[{'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Tobin', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Division of Surgical Oncology, Department of Surgery, USA. Electronic address: richard.tobin@ucdenver.edu.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Jordan', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Department of Immunology and Microbiology, USA. Electronic address: kimberly.jordan@ucdenver.edu.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Robinson', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Division of Medical Oncology, Department of Medicine, USA; University of Colorado Cancer Center, Aurora, CO, USA. Electronic address: william.robinson@ucdenver.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Division of Surgical Oncology, Department of Surgery, USA. Electronic address: dana.davis@ucdenver.edu.'}, {'ForeName': 'Virginia F', 'Initials': 'VF', 'LastName': 'Borges', 'Affiliation': ""University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Division of Medical Oncology, Department of Medicine, USA; Young Women's Breast Cancer Translational Program, USA; University of Colorado Cancer Center, Aurora, CO, USA. Electronic address: virginia.borges@ucdenver.edu.""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Division of Medical Oncology, Department of Medicine, USA; University of Colorado Cancer Center, Aurora, CO, USA. Electronic address: rene.gonzalez@ucdenver.edu.'}, {'ForeName': 'Karl D', 'Initials': 'KD', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Division of Medical Oncology, Department of Medicine, USA; University of Colorado Cancer Center, Aurora, CO, USA. Electronic address: karl.lewis@ucdenver.edu.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'McCarter', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA; Division of Surgical Oncology, Department of Surgery, USA; University of Colorado Cancer Center, Aurora, CO, USA. Electronic address: martin.mccarter@ucdenver.edu.'}]",International immunopharmacology,['10.1016/j.intimp.2018.08.007']
706,30373502,Feasibility study by a single-blind randomized controlled trial of self-management of mobility with a gait-speed feedback device by older persons at risk for falling.,"This single-blind randomized pilot study explored feasibility and safety of a self-management fall prevention program, hypothesizing that older persons can comply with this program, while it does not result in more (injurious) falls, or a decrease in mental wellbeing as an adverse effect of being focused on falls prevention. Eighty-six persons, community-dwelling or home for the aged (mean age 80.3 years [SD: 6.3], 56 women (65.1%)) participated. The intervention group measured their gait speed by using the Mobility Feedback Device (MFD) weekly for 6 months. The control group was monitored for the outcomes without an intervention. Change scores involving health perception and mental wellbeing (Medical Outcomes Study 20-item short form (MOS-20)) were compared between groups. Feasibility was assessed by drop-out rate and compliance to measure gait speed. Safety was assessed by fall incidence during follow-up. MOS-20 decreased significantly in the control group ( p = 0.024) but remained stable in the intervention group. Drop-out rate was low (9.3%), and compliance was good. Fall incidence was the same for both groups ( p = 0.155). The self-management fall prevention program is feasible and safe in a community-dwelling and home for the aged population, making it worthwhile to further explore self-management fall-prevention studies.",2020,"The self-management fall prevention program is feasible and safe in a community-dwelling and home for the aged population, making it worthwhile to further explore self-management fall-prevention studies.","['Eighty-six persons, community-dwelling or home for the aged (mean age 80.3\xa0years', 'older persons', 'older persons at risk for falling', '56 women (65.1%)) participated']","['self-management fall prevention program', 'self-management of mobility with a gait-speed feedback device', 'gait speed by using the Mobility Feedback Device (MFD) weekly for 6\xa0months']","['Fall incidence', 'fall incidence during follow-up. MOS-20', 'Change scores involving health perception and mental wellbeing (Medical Outcomes Study 20-item short form (MOS-20', 'Safety']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",86.0,0.0215836,"The self-management fall prevention program is feasible and safe in a community-dwelling and home for the aged population, making it worthwhile to further explore self-management fall-prevention studies.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Schoon', 'Affiliation': 'Department of Geriatric Medicine (925), Radboud University Medical Center , Nijmegen, The Netherlands.'}, {'ForeName': 'Kim T J', 'Initials': 'KTJ', 'LastName': 'Bongers', 'Affiliation': 'Department of Geriatric Medicine (925), Radboud University Medical Center , Nijmegen, The Netherlands.'}, {'ForeName': 'Marcel G M', 'Initials': 'MGM', 'LastName': 'Olde Rikkert', 'Affiliation': 'Department of Geriatric Medicine (925), Radboud University Medical Center , Nijmegen, The Netherlands.'}]",Assistive technology : the official journal of RESNA,['10.1080/10400435.2018.1529004']
707,32409111,Melatonin and melatonin agonists as treatments for benzodiazepines and hypnotics withdrawal in patients with primary insomnia. A systematic review.,"BACKGROUND
Hypnotics (HYP) and benzodiazepines (BZD) are medicines prescribed for the insomnia treatment. Many patients present difficulties in discontinuing the treatment once established. Melatonin (MLT) has been prescribed as a treatment for BZD/HYP detoxification.
AIMS
The primary objective of this systematic review is to assess the efficacy of MLT and MLT agonists (melatoninergics) in improving the rate of BZD and/or HYP discontinuation among adults with primary insomnia attempting to discontinue BZD and/or HYP. The secondary objective is to evaluate the partial efficacy of melatoninergic drugs in the discontinuation of BZD and/or HYP consumption in subjects that could not stop their consumption.
METHOD
A search on Web of Science and Scopus was carried out from database inception to July 1st, 2019.
RESULTS
Three hundred and forty-nine articles were identified but only four were included in the final review. Two were cohort prospective, one placebo-control double blind and one double blind placebo-control cross-over designed study. Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm. In cohort studies TW figures ranged from 30.8% to 65%. Partial withdrawal ranged between 20% and 30.8% of patients that did not achieve TW with reduction figures of diazepam equivalent dose ranging from 25% to 75%.
CONCLUSION
MLT has a place in the physician armamentarium to treat the suspension/reduction of BZD/HYP consumption in patients with primary insomnia.",2020,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"['patients with primary insomnia', 'Three hundred and forty-nine articles were identified but only four were included in the final review', 'adults with primary insomnia attempting to discontinue BZD and/or HYP', 'subjects that could not stop their consumption']","['MLT and MLT agonists (melatoninergics', 'placebo-control double blind and one double blind placebo-control cross', 'MLT', 'Melatonin and melatonin agonists', 'diazepam', 'Melatonin (MLT', 'benzodiazepines', 'Hypnotics (HYP) and benzodiazepines (BZD', 'placebo']","['rate of BZD and/or HYP discontinuation', 'Total withdrawal (TW', 'Partial withdrawal ranged']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1635027', 'cui_str': 'Melatonin agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0020591', 'cui_str': 'Hypnotic agent'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",349.0,0.110412,Total withdrawal (TW) ranged from 0% to 25% in the placebo arm and from 64.3% to 77.8% in the MLT arm.,"[{'ForeName': 'Armando L', 'Initials': 'AL', 'LastName': 'Morera-Fumero', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Consultoría Psiquiátrica SC, Santa Cruz de Tenerife, Spain. Electronic address: amorera@ull.edu.es.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Fernandez-Lopez', 'Affiliation': 'Departamento de Medicina Interna, Dermatología y Psiquiatría. Facultad de Ciencias de la Salud, Universidad de La Laguna, La Laguna, Santa Cruz de Tenerife, Spain; Sociedad para la Investigación y Asistencia en Salud Mental, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Abreu-Gonzalez', 'Affiliation': 'Departamento de Ciencias Médicas Básicas: Unidad de Fisiología. Facultad de Ciencias de la Salud. Universidad de la Laguna, la Laguna, Santa Cruz de Tenerife, Spain.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.107994']
708,31652237,Impact of Exercise-Nutritional State Interactions in Patients with Type 2 Diabetes.,"INTRODUCTION
This study examines the role of nutritional status during exercise training in patients with type 2 diabetes mellitus by investigating the effect of endurance-type exercise training in the fasted versus the fed state on clinical outcome measures, glycemic control, and skeletal muscle characteristics in male type 2 diabetes patients.
METHODS
Twenty-five male patients (glycated hemoglobin (HbA1c), 57 ± 3 mmol·mol (7.4% ± 0.3%)) participated in a randomized 12-wk supervised endurance-type exercise intervention, with exercise being performed in an overnight-fasted state (n = 13) or after consuming breakfast (n = 12). Patients were evaluated for glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression.
RESULTS
Exercise training was well tolerated without any incident of hypoglycemia. Exercise training significantly decreased whole-body fat mass (-1.6 kg) and increased high-density lipoprotein concentrations (+2 mg·dL), physical fitness (+1.7 mL·min·kg), and fat oxidation during exercise in both groups (PTIME < 0.05), with no between-group differences (PTIME × GROUP > 0.05). HbA1c concentrations significantly decreased after exercise training (PTIME < 0.001), with a significant greater reduction after consuming breakfast (-0.30% ± 0.06%) compared with fasted state (-0.08% ± 0.06%; mean difference, 0.21%; PTIME × GROUP = 0.016). No interaction effects were observed for skeletal muscle genes related to lipid metabolism or oxidative capacity.
CONCLUSIONS
Endurance-type exercise training in the fasted or fed state do not differ in their efficacy to reduce fat mass, increase fat oxidation capacity, and increase cardiorespiratory fitness and high-density lipoprotein concentrations or their risk of hypoglycemia in male patients with type 2 diabetes. HbA1c seems to be improved more with exercise performed in the postprandial compared with the postabsorptive state.",2020,"HbA1c concentrations significantly decreased after exercise training (PTIME<0.001), with a significant greater reduction in FedEx (-0.30±0.06%) compared to FastEx","['Twenty-five male patients (HbA1c 57±3 mmol/mol (7.4±0.3%)) participated in a randomized 12-week', 'male patients with type 2 diabetes', 'male type 2 diabetes patients', 'patients with type 2 diabetes mellitus', 'Patients with Type 2 Diabetes']","['Exercise-Nutritional State Interactions', 'FastEx', 'endurance-type exercise training', 'Exercise training', 'supervised endurance-type exercise intervention, with exercise being performed in an overnight fasted state (FastEx, n=13) or after consuming breakfast (FedEx', 'Endurance-type exercise training', 'exercise training']","['HDL concentrations (+2mg*dL), physical fitness (+1.7mL*min*kg) and fat oxidation during exercise', 'whole-body fat mass', 'glycemic control, blood lipid profiles, body composition and physical fitness, and skeletal muscle gene expression', 'lipid metabolism or oxidative capacity', 'Glycated haemoglobin', 'cardiorespiratory fitness and HDL concentrations', 'HbA1c concentrations', 'FedEx', 'tolerated without any incident of hypoglycemia']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",25.0,0.0307651,"HbA1c concentrations significantly decreased after exercise training (PTIME<0.001), with a significant greater reduction in FedEx (-0.30±0.06%) compared to FastEx","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Verboven', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Wens', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vandenabeele', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Stevens', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Celie', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lapauw', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dendale', 'Affiliation': 'Heart Centre Hasselt, Jessa Hospital, Hasselt, BELGIUM.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'VAN Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, Maastricht, NETHERLANDS.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Calders', 'Affiliation': 'Department of Endocrinology, Ghent University Hospital, Ghent, BELGIUM.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Hansen', 'Affiliation': 'Rehabilitation Research Centre (REVAL), Biomedical Research Unit (BIOMED), Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, BELGIUM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002165']
709,30035566,Cross-cultural consistency and relativity in the enjoyment of thinking versus doing.,"Which is more enjoyable: trying to think enjoyable thoughts or doing everyday solitary activities? Wilson et al. (2014) found that American participants much preferred solitary everyday activities, such as reading or watching TV, to thinking for pleasure. To see whether this preference generalized outside of the United States, we replicated the study with 2,557 participants from 12 sites in 11 countries. The results were consistent in every country: Participants randomly assigned to do something reported significantly greater enjoyment than did participants randomly assigned to think for pleasure. Although we found systematic differences by country in how much participants enjoyed thinking for pleasure, we used a series of nested structural equation models to show that these differences were fully accounted for by country-level variation in 5 individual differences, 4 of which were positively correlated with thinking for pleasure (need for cognition, openness to experience, meditation experience, and initial positive affect) and 1 of which was negatively correlated (reported phone usage). (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,The results were consistent in every country: Participants randomly assigned to do something reported significantly greater enjoyment than did participants randomly assigned to think for pleasure.,"['2,557 participants from 12 sites in 11 countries']",[],"['solitary everyday activities, such as reading or watching TV, to thinking for pleasure']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",2557.0,0.0211685,The results were consistent in every country: Participants randomly assigned to do something reported significantly greater enjoyment than did participants randomly assigned to think for pleasure.,"[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Buttrick', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Shigehiro', 'Initials': 'S', 'LastName': 'Oishi', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Boker', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Alper', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Aveyard', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Winnee', 'Initials': 'W', 'LastName': 'Cheong', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Marija V', 'Initials': 'MV', 'LastName': 'Čolić', 'Affiliation': 'Institute for Medical Research.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Dalgar', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Canay', 'Initials': 'C', 'LastName': 'Doğulu', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Serdar', 'Initials': 'S', 'LastName': 'Karabati', 'Affiliation': 'Department of Business.'}, {'ForeName': 'Eunbee', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Knežević', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Komiya', 'Affiliation': 'Research Institute for Future Design.'}, {'ForeName': 'Camila Ordóñez', 'Initials': 'CO', 'LastName': 'Laclé', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Caio', 'Initials': 'C', 'LastName': 'Ambrosio Lage', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ljiljana B', 'Initials': 'LB', 'LastName': 'Lazarević', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Dušanka', 'Initials': 'D', 'LastName': 'Lazarević', 'Affiliation': 'Faculty of Sport and Physical Education.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Lins', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Blanco Molina', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Neto', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Orlić', 'Affiliation': 'Faculty of Sport and Physical Education.'}, {'ForeName': 'Boban', 'Initials': 'B', 'LastName': 'Petrović', 'Affiliation': 'Institute of Criminological and Sociological Research.'}, {'ForeName': 'Massiel', 'Initials': 'M', 'LastName': 'Arroyo Sibaja', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torres Fernández', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Wolf', 'Initials': 'W', 'LastName': 'Vanpaemel', 'Affiliation': 'Faculty of Psychology and Educational Sciences.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Voorspoels', 'Affiliation': 'Faculty of Psychology and Educational Sciences.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Wilks', 'Affiliation': 'Department of Psychology.'}]",Journal of personality and social psychology,['10.1037/pspp0000198']
710,30114712,Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial.,"BACKGROUND
Adequate pain control after cardiac surgery is essential. Paravertebral block is a simple technique and avoids the potential complications of epidural catheters. The objective of this study is to compare the effect of ultrasound-guided bilateral thoracic paravertebral block with thoracic epidural block on pain control after cardiac surgery.
MATERIALS AND METHODS
Between March 2016 and 2017, 145 patients who had cardiac surgery through median sternotomy were randomized by stratified blocked randomization into two groups. Group I ( n = 70 patients) had bilateral ultrasound-guided thoracic paravertebral block and Group II ( n = 75 patients) had thoracic epidural analgesia. The primary end point was the postoperative visual analogue scale (VAS). The duration of mechanical ventilation, intensive care unit (ICU), and hospital stay were the secondary end points. The study design is a randomized parallel superiority clinical trial.
RESULTS
Both groups had similar preoperative and operative characteristics. No significant difference in VAS measured immediately after endotracheal extubation then after 12, 24, and 48 hours between groups ( p = 0.45). Pain score significantly declined with the repeated measures ( p < 0.001) and the decline was not related to the treatment group. Postoperative pain was significantly related to diabetes mellitus ( p = 0.039). Six patients in group I (8.5%) required an additional dose of morphine versus three patients (4%) in group II ( p = 0.30). Patients in group I had significantly shorter ICU stay ( p = 0.005) and lower incidence of urinary retention ( p = 0.04) and vomiting ( p = 0.018). No difference was found in operative complications between groups.
CONCLUSION
This randomized parallel controlled trial demonstrates that ultrasound-guided paravertebral block is safe and effective method for relieving post-cardiac surgery sternotomy pain compared with thoracic epidural analgesia but not superior to it.",2020,Patients in group I had significantly shorter ICU stay ( p = 0.005) and lower incidence of urinary retention ( p = 0.04) and vomiting ( p = 0.018).,"['Six patients in group', '145 patients who had cardiac surgery through median sternotomy', 'Between March 2016 and 2017', 'Pain Control Post-Cardiac Surgery']","['ultrasound-guided paravertebral block', 'bilateral ultrasound-guided thoracic paravertebral block and Group II', 'ultrasound-guided bilateral thoracic paravertebral block with thoracic epidural block', 'morphine', 'Bilateral Paravertebral Block versus Thoracic Epidural Analgesia', 'thoracic epidural analgesia']","['vomiting', 'operative complications', 'diabetes mellitus', 'postoperative visual analogue scale (VAS', 'shorter ICU stay', 'Postoperative pain', 'urinary retention', 'VAS', 'pain control', 'thoracic epidural analgesia', 'Pain score', 'duration of mechanical ventilation, intensive care unit (ICU), and hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1282959', 'cui_str': 'Median Sternotomy'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0394835', 'cui_str': 'Local anesthetic thoracic epidural block (procedure)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",,0.112836,Patients in group I had significantly shorter ICU stay ( p = 0.005) and lower incidence of urinary retention ( p = 0.04) and vomiting ( p = 0.018).,"[{'ForeName': 'Hatem A', 'Initials': 'HA', 'LastName': 'El Shora', 'Affiliation': 'Anesthesia and Surgical ICU Department, Faculty of Medicine-Tanta University, Tanta, Gharbeya, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'El Beleehy', 'Affiliation': 'Anesthesia and Surgical ICU Department, Faculty of Medicine-Tanta University, Tanta, Gharbeya, Egypt.'}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Abdelwahab', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine-Tanta University, Tanta, Gharbeya, Egypt.'}, {'ForeName': 'Gaser A', 'Initials': 'GA', 'LastName': 'Ali', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine- Zagazig University, Zagazig, Sharkia, Egypt.'}, {'ForeName': 'Tarek E', 'Initials': 'TE', 'LastName': 'Omran', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine-Tanta University, Tanta, Gharbeya, Egypt.'}, {'ForeName': 'Essam A', 'Initials': 'EA', 'LastName': 'Hassan', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine-Tanta University, Tanta, Gharbeya, Egypt.'}, {'ForeName': 'Amr A', 'Initials': 'AA', 'LastName': 'Arafat', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine-Tanta University, Tanta, Gharbeya, Egypt.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0038-1668496']
711,30081019,Efficacy of Tocilizumab in Patients With Moderate-to-Severe Corticosteroid-Resistant Graves Orbitopathy: A Randomized Clinical Trial.,"OBJECTIVE
To demonstrate the efficacy of the anti-interleukin-6 receptor monoclonal antibody tocilizumab in patients with moderate-to-severe corticosteroid-resistant Graves orbitopathy (GO).
DESIGN
Double-masked randomized clinical trial.
METHODS
Setting and Participants: Thirty-two adults with moderate-to-severe corticosteroid-resistant GO from 10 medical centers in Spain were randomized (1:1).
INTERVENTION
Randomization to either 8 mg/kg body weight tocilizumab or placebo administered intravenously at weeks 0, 4, 8, and 12, and follow-up for an additional 28 weeks. Main Outcomes and Measures: The primary outcome was the proportion of patients with a change from baseline to week 16 of at least 2 in the clinical activity score (CAS).
RESULTS
The primary outcome was met by 93.3% (95% confidence interval [CI] 70.1%-98.8%) of the patients receiving tocilizumab and 58.8% (36%-78.3%) receiving placebo (P = .04; odds ratio, 9.8 [CI 1.3-73.2]). A significant difference was also observed in the proportion of patients achieving a CAS < 3 (86.7% [CI 62.1%-96.2%] vs 35.2% [CI 17.3%-58.7%], P = .005; OR 11.9 [CI 2.1-63.1]) at week 16. Additionally, a larger proportion of patients with improvement in the European Group on GO-proposed composite ophthalmic score at week 16 (73.3% [CI 48%-89.1%] vs 29.4% [CI 13.2%-53.1%]; P = .03), and exophthalmos size change from baseline to week 16 (-1.5 [-2.0 to 0.5] mm vs 0.0 [-1.0 to 0.5] mm; P = .01) were seen with tocilizumab. One patient experienced a moderate increase in transaminases at week 8; another had an acute pyelonephritis at week 32 in the tocilizumab-treated group.
CONCLUSION
Tocilizumab offers a meaningful improvement in activity and severity in corticosteroid-resistant GO. This trial justifies further studies to characterize the role of tocilizumab in GO.",2018,"A significant difference was also observed in the proportion of patients achieving a CAS < 3 (86.7% [CI 62.1%-96.2%] vs 35.2% [CI 17.3%-58.7%], P = .005; OR 11.9 [CI 2.1-63.1]) at week 16.","['Patients With Moderate-to-Severe Corticosteroid-Resistant Graves', 'Setting and Participants', 'Thirty-two adults with moderate-to-severe corticosteroid-resistant GO from 10 medical centers in Spain', 'patients with moderate-to-severe corticosteroid-resistant Graves orbitopathy (GO']","['tocilizumab', 'anti-interleukin-6 receptor monoclonal antibody tocilizumab', 'placebo', 'Orbitopathy', 'Tocilizumab', 'Randomization to either 8\xa0mg/kg body weight tocilizumab or placebo']","['proportion of patients with a change', 'clinical activity score (CAS', 'proportion of patients achieving a CAS', 'GO-proposed composite ophthalmic score', 'transaminases', 'exophthalmos size change', 'acute pyelonephritis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205116', 'cui_str': 'Efferent (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0339143', 'cui_str': 'Graves Ophthalmopathy'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0560741', 'cui_str': 'milligram/kg body weight'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis (disorder)'}]",32.0,0.36542,"A significant difference was also observed in the proportion of patients achieving a CAS < 3 (86.7% [CI 62.1%-96.2%] vs 35.2% [CI 17.3%-58.7%], P = .005; OR 11.9 [CI 2.1-63.1]) at week 16.","[{'ForeName': 'Jose V', 'Initials': 'JV', 'LastName': 'Perez-Moreiras', 'Affiliation': 'Instituto Internacional de Orbita y Oculoplastica, Santiago, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Gomez-Reino', 'Affiliation': 'Fundación Ramon Dominguez, IDIS, Hospital Clinico Universitario, Santiago, Spain.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Maneiro', 'Affiliation': 'Rheumatology Service, Hospital Clinico Universitario, Santiago, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Perez-Pampin', 'Affiliation': 'Fundación Ramon Dominguez, IDIS, Hospital Clinico Universitario, Santiago, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Romo Lopez', 'Affiliation': 'Ophthalmology and Endocrinology Services, Hospital Clínico, Madrid, Spain.'}, {'ForeName': 'Fernando M', 'Initials': 'FM', 'LastName': 'Rodríguez Alvarez', 'Affiliation': 'Ophthalmology, Endocrinology, and Rheumatology Services, Hospital Universitario de la Santa Creu i San Pau, Barcelona, Spain.'}, {'ForeName': 'Jesús M', 'Initials': 'JM', 'LastName': 'Castillo Laguarta', 'Affiliation': 'Ophthalmology and Rheumatology Services, Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Del Estad Cabello', 'Affiliation': 'Ophthalmology, Endocrinology, and Rheumatology Services, Hospital Universitario, Virgen de Rocio, Sevilla, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Gessa Sorroche', 'Affiliation': 'Ophthalmology, Clinical Pharmacology, Endocrinology, and Rheumatology Services, Hospital Universitario Virgen de la Macarena, Sevilla, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'España Gregori', 'Affiliation': 'Ophthalmology, Endocrinology, and Internal Medicine Services, Hospital Universitario La Fe, Valencia, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sales-Sanz', 'Affiliation': 'Ophthalmology and Rheumatology Services, Hospital Universitario Ramon y Cajal, Madrid, Spain. Electronic address: salessanz@yahoo.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2018.07.038']
712,30247454,Estimating the Weight of Children During Simulated Emergency Situations Using the Broselow Tape: Are We Underestimating the Risks of Errors?,"OBJECTIVE
The objective of this study was to evaluate whether residents can accurately estimate children's weight using the Broselow tape.
METHOD
We conducted a preplanned secondary analysis from an experimental trial. Participants were residents in pediatrics, family medicine, and emergency medicine rotating in the ED. Residents were randomly assigned to 2 sets of paired scenarios during 2 sessions. They were asked to estimate the weight of a manikin using the Broselow tape at the beginning of each scenario. The first scenario from the initial session and the last scenario from the second session were used for the current study. The primary analysis was the proportion of participants who accurately estimated manikin weight within a 10% margin of error.
RESULTS
Forty residents were recruited. Thirty-two (80%) reported knowledge of the Broselow tape and 13 (32.5%) reported previous use. Weight estimation was accurate in 60% (24/40; 95% confidence interval [CI], 45%-74%) during the first scenarios. Error in weight estimation differed by greater than 25% in 28% (11/40). Error in estimation was not associated with previous knowledge (odds ratio, 6.2; 95% CI, 0.68-56) or previous use (odds ratio, 0.9; 95% CI, 0.23-3.5) of the Broselow tape. In the last scenario, 88% accurately estimated manikin weight (35/40; 95% CI, 73%-95%).
CONCLUSIONS
Although most residents reported knowledge of the Broselow tape, 40% made erroneous weight estimations by at least 10% with the first use in this simulation study. With repeated use, they improved significantly over time. Teaching appropriate use of the Broselow tape should be part of residency-training curricula and pediatric advanced life support course.",2020,"Error in estimation was not associated with previous knowledge (odds ratio, 6.2; 95% CI, 0.68-56) or previous use (odds ratio, 0.9; 95% CI, 0.23-3.5) of the Broselow tape.","['Forty residents were recruited', 'Participants were residents in pediatrics, family medicine, and emergency medicine rotating in the ED']",['Broselow Tape'],"['erroneous weight estimations', 'manikin weight', 'Weight estimation', 'proportion of participants who accurately estimated manikin weight', 'knowledge of the Broselow tape', 'Error in weight estimation', 'Weight of Children']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0013964', 'cui_str': 'Emergency Medicine'}, {'cui': 'C0231458', 'cui_str': 'Rotated (qualifier value)'}]","[{'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}]","[{'cui': 'C3541364', 'cui_str': 'Erroneous component'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",40.0,0.0522277,"Error in estimation was not associated with previous knowledge (odds ratio, 6.2; 95% CI, 0.68-56) or previous use (odds ratio, 0.9; 95% CI, 0.23-3.5) of the Broselow tape.","[{'ForeName': 'Guylaine', 'Initials': 'G', 'LastName': 'Larose', 'Affiliation': 'From the Division of Emergency Medicine, Department of Pediatrics.'}, {'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'From the Division of Emergency Medicine, Department of Pediatrics.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Bailey', 'Affiliation': 'From the Division of Emergency Medicine, Department of Pediatrics.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cummins-McManus', 'Affiliation': 'From the Division of Emergency Medicine, Department of Pediatrics.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Lebel', 'Affiliation': 'Department of Pharmacy, Faculty of Medicine, CHU Sainte-Justine, Université de Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Gravel', 'Affiliation': 'From the Division of Emergency Medicine, Department of Pediatrics.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001581']
713,31365834,Combined consumption of a single high-dose vitamin A supplement with provision of vitamin A fortified oil to households maintains adequate milk retinol concentrations for 6 months in lactating Moroccan women.,"In Morocco, postpartum women systematically receive a single, high dose of vitamin A (VA; 200 000 IU) within the first month of giving birth and vegetable oil is fortified to increase the VA intake. The efficacy of this combined approach of supplementation and fortification for increasing maternal VA status during lactation is not known. The purpose of the study is to evaluate the effect of postpartum high dose VA supplementation and provision of VA fortified oil for household consumption on plasma and milk retinol concentrations of lactating Moroccan women during the first 6 months after giving birth. Postpartum women aged 19-40 years received a VA supplement and thereafter were randomly assigned to one of two groups to receive weekly vitamin A fortified oil (FO) or non-fortified oil (NFO) for 6 months. Serum retinol concentration was higher in the FO group than in the NFO group at 6 months after giving birth ( p < 0.0001). Milk retinol per gram fat at baseline did not differ by group; by 3 months after giving birth, milk retinol per gram fat was higher in the FO group than in the NFO group ( p = 0.02) and remained higher throughout the 6 months ( p < 0.0001). The combination of supplementation and fortification has a more sustained impact on milk retinol concentrations than supplementation alone, which did not have a sustained impact on milk VA concentrations. The fortification approach seems to be more effective for maintaining adequate milk VA concentrations among lactating Moroccan women. Fortification seems to be a long-term solution for the problem of VA deficiency, especially among women in low-income communities.",2020,Serum retinol concentration was higher in the FO group than in the NFO group at 6 mo post-partum (P<0.0001).,"['Post-partum women aged 19-40 y received a', 'lactating Moroccan women', 'lactating Moroccan women during the first 6 mo post-partum']","['vitamin A (VA', 'vitamin A Fortified Oil (FO) or Non-Fortified Oil (NFO', 'VA supplement', 'NFO']","['milk VA concentrations', 'Serum retinol concentration', 'Milk retinol per g fat', 'milk retinol per g fat', 'plasma and milk retinol concentrations', 'milk retinol concentrations']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}]","[{'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0028908', 'cui_str': 'Oils'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0087161', 'cui_str': 'All-Trans-Retinol'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",,0.130371,Serum retinol concentration was higher in the FO group than in the NFO group at 6 mo post-partum (P<0.0001).,"[{'ForeName': 'Naima', 'Initials': 'N', 'LastName': 'Atalhi', 'Affiliation': 'Unité Mixte de Recherche en Nutrition et Alimentation, URAC39, Regional Designated Center of Nutrition Associated with AFRA/IAEA, CNESTEN, Université Ibn Tofaïl, Rabat, Kénitra, Morocco.'}, {'ForeName': 'Asmaa', 'Initials': 'A', 'LastName': 'El Hamdouchi', 'Affiliation': 'Unité Mixte de Recherche en Nutrition et Alimentation, URAC39, Regional Designated Center of Nutrition Associated with AFRA/IAEA, CNESTEN, Université Ibn Tofaïl, Rabat, Kénitra, Morocco.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Barkat', 'Affiliation': 'Health and Nutrition Research Team of the Mother Child Couple, Faculty of Medicine, Université Mohammed V, Souissi, Rabat, Morocco.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Elkari', 'Affiliation': 'Unité Mixte de Recherche en Nutrition et Alimentation, URAC39, Regional Designated Center of Nutrition Associated with AFRA/IAEA, CNESTEN, Université Ibn Tofaïl, Rabat, Kénitra, Morocco.'}, {'ForeName': 'Abdeslam', 'Initials': 'A', 'LastName': 'Hamrani', 'Affiliation': 'Unité Mixte de Recherche en Nutrition et Alimentation, URAC39, Regional Designated Center of Nutrition Associated with AFRA/IAEA, CNESTEN, Université Ibn Tofaïl, Rabat, Kénitra, Morocco.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'El Mzibri', 'Affiliation': 'Unité Mixte de Recherche en Nutrition et Alimentation, URAC39, Regional Designated Center of Nutrition Associated with AFRA/IAEA, CNESTEN, Université Ibn Tofaïl, Rabat, Kénitra, Morocco.'}, {'ForeName': 'Marjorie J', 'Initials': 'MJ', 'LastName': 'Haskell', 'Affiliation': 'Program in International and Community Nutrition and Department of Nutrition, University of California, Davis, CA 95616, USA.'}, {'ForeName': 'Najat', 'Initials': 'N', 'LastName': 'Mokhtar', 'Affiliation': 'Unité Mixte de Recherche en Nutrition et Alimentation, URAC39, Regional Designated Center of Nutrition Associated with AFRA/IAEA, CNESTEN, Université Ibn Tofaïl, Rabat, Kénitra, Morocco.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Aguenaou', 'Affiliation': 'Unité Mixte de Recherche en Nutrition et Alimentation, URAC39, Regional Designated Center of Nutrition Associated with AFRA/IAEA, CNESTEN, Université Ibn Tofaïl, Rabat, Kénitra, Morocco.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0116']
714,31648655,Pregabalin augmentation for resistant obsessive-compulsive disorder: a double-blind placebo-controlled clinical trial.,"BACKGROUND AND OBJECTIVE
Glutamate dysfunction has been shown to be associated with pathophysiology of obsessive-compulsive disorder (OCD). Our objective is to survey the effects of pregabalin (a glutamate-modulating agent) as an augmenting treatment for resistant OCD.
PATIENTS AND METHODS
In this 12-week double-blind placebo-controlled clinical trial, 56 patients with resistant OCD were randomly allocated to receive either pregabalin or placebo plus their current medication (sertraline). Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was used to evaluate the outcomes. Adverse effects were also registered.
RESULTS
Of the 56 patients with resistant OCD who were randomly allocated in 2 groups of pregabalin (n = 28) and placebo group (n = 28), 42 patients (22 in pregabalin group and 20 in placebo group) completed the trial. Throughout the trial, the mean score decreased from 26.13± 7.03 to 8.81 ± 3.47 in the pregabalin group (p < 0) and from 26.85 ± 4.34 to 17.63 ± 4.22 in the placebo group (p < 0). At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01). The pregabalin group showed good tolerability and safety.
CONCLUSIONS
Our study revealed that pregabalin, as an augmenting medication, is more effective than placebo in the treatment of patients with resistant OCD.",2020,"At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01).","['patients with resistant OCD', 'resistant obsessive-compulsive disorder', '56 patients with resistant OCD']","['pregabalin', 'Pregabalin augmentation', 'pregabalin or placebo plus their current medication (sertraline', 'placebo', 'pregabalin group and 20 in placebo']","['YBOCS', 'Yale-Brown Obsessive Compulsive Scale', 'good tolerability and safety', 'mean score', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",56.0,0.333824,"At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01).","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mowla', 'Affiliation': 'Substance Abuse and Mental Health Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Ghaedsharaf', 'Affiliation': 'Substance Abuse and Mental Health Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",CNS spectrums,['10.1017/S1092852919001500']
715,30068245,A School- and Home-Based Intervention to Improve Adolescents' Physical Activity and Healthy Eating: A Pilot Study.,"This study evaluated feasibility, acceptability, and preliminary efficacy of a 12-week Guys/Girls Opt for Activities for Life (GOAL) intervention on 10- to 13-year-old adolescents' body mass index (BMI), percent body fat, physical activity (PA), diet quality, and psychosocial perceptions related to PA and healthy eating. Parent-adolescent dyads from two schools were enrolled. Schools were assigned to either GOAL (38 dyads) or control (43 dyads) condition. The intervention included an after-school club for adolescents 2 days/week, parent-adolescent dyad meeting, and parent Facebook group. Intervention adolescents had greater autonomous motivation for PA and self-efficacy for healthy eating than control adolescents (both p < .05). Although between-group differences were not significant, close-to-moderate effect sizes resulted for accelerometer-measured moderate-to-vigorous PA and diet quality measured via 24-hr dietary recall ( d = .46 and .44, respectively). A trivial effect size occurred for percent body fat ( d = -.10). No differences emerged for BMI. Efficacy testing with a larger sample may be warranted.",2020,Intervention adolescents had greater autonomous motivation for PA and self-efficacy for healthy eating than control adolescents (both p < .05).,"['10- to 13-year-old adolescents', ""Adolescents' Physical Activity and Healthy Eating"", 'Parent-adolescent dyads from two schools were enrolled']","['12-week Guys/Girls Opt for Activities for Life (GOAL) intervention', 'School- and Home-Based Intervention']","['BMI', 'accelerometer-measured moderate-to-vigorous PA and diet quality measured via 24-hr dietary recall', 'body mass index (BMI), percent body fat, physical activity (PA), diet quality, and psychosocial perceptions related to PA and healthy eating', 'autonomous motivation for PA and self-efficacy']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",2.0,0.0212306,Intervention adolescents had greater autonomous motivation for PA and self-efficacy for healthy eating than control adolescents (both p < .05).,"[{'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Clevenger', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Vicki R', 'Initials': 'VR', 'LastName': 'Voskuil', 'Affiliation': 'Nursing Department, Hope College, Holland, MI, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wasilevich', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Kerver', 'Affiliation': 'Department of Epidemiology and Biostatistics, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Center for Human Growth and Development, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Karin A', 'Initials': 'KA', 'LastName': 'Pfeiffer', 'Affiliation': 'Department of Kinesiology, Michigan State University, East Lansing, MI, USA.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840518791290']
716,30033738,Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State.,"OBJECTIVE
The purpose of this study was to evaluate changes in the synovial fluid proteome following acute anterior cruciate ligament (ACL) injury.
DESIGN
This study represents a secondary analysis of synovial fluid samples collected from the placebo group of a previous randomized trial. Arthrocentesis was performed twice on 6 patients with an isolated acute ACL tear at a mean of 6 and 14 days postinjury. Synovial fluid was analyzed by a highly multiplexed assay of 1129 proteins (SOMAscan version 3, SomaLogic, Inc., Boulder, CO). Pathway analysis using DAVID was performed; genes included met 3 criteria: significant change between the 2 study time points using a paired t test, significant change between the 2 study time points using a Mann-Whitney nonparametric test, and significant Benjamini post hoc analysis.
RESULTS
Fifteen analytes demonstrated significant increases between time points. Five of the 15 have been previously associated with the onset and/or severity of rheumatoid arthritis, including apoliopoprotein E and isoform E3, vascular cell adhesion protein 1, interleukin-34, and cell surface glycoprotein CD200 receptor 1. Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury: MMP-1 ( P = 0.08, standardized response mean [SRM] = 1.00), MMP-3 ( P = 0.05, SRM = 0.90), ADAM12 ( P = 0.03, SRM = 1.31), aggrecan ( P = 0.08, SRM = 1.13), and CTX-II ( P = 0.07, SRM = 0.56). Notable pathways that were differentially expressed following injury were the cytokine-cytokine receptor interaction and osteoclast differentiation pathways.
CONCLUSIONS
The proteomic results and pathway analysis demonstrated a pattern of cartilage degeneration, not only consistent with previous findings but also changes consistent with an inflammatory arthritogenic process post-ACL injury.",2020,Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury:,"['injury', 'acute anterior cruciate ligament (ACL) injury', 'Anterior Cruciate Ligament Rupture']","['placebo', 'ADAM12']","['MMP-3', 'MMP-1', 'Chondrodegenerative enzymes and products of cartilage degeneration']","[{'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0011164', 'cui_str': 'Degenerative abnormality'}]",6.0,0.0632535,Chondrodegenerative enzymes and products of cartilage degeneration all increased over time following injury:,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'King', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Rowland', 'Affiliation': 'Central Texas Sports Medicine & Orthopedics, Bryan, TX, USA.'}, {'ForeName': 'Alejandro G', 'Initials': 'AG', 'LastName': 'Villasante Tezanos', 'Affiliation': 'College of Health Sciences, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Virginia B', 'Initials': 'VB', 'LastName': 'Kraus', 'Affiliation': 'Duke Molecular Physiology Institute, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': ""Department of Orthopaedic Surgery, Harvard Medical School and Brigham and Women's Hosptial, Chestnut Hill, MS, USA.""}, {'ForeName': 'Cale A', 'Initials': 'CA', 'LastName': 'Jacobs', 'Affiliation': 'Department of Orthopedic Surgery, University of Kentucky, Lexington, KY, USA.'}]",Cartilage,['10.1177/1947603518790009']
717,30039159,Effect of Oxygen vs Room Air on Intrauterine Fetal Resuscitation: A Randomized Noninferiority Clinical Trial.,"Importance
Two-thirds of women in labor receive supplemental oxygen to reverse perceived fetal hypoxemia and prevent acidemia. Oxygen is routinely administered for category II fetal heart tracings, a class of fetal tracing used to designate intermediate risk for acidemia. This liberal use of oxygen may not be beneficial, particularly because neonatal hyperoxygenation is harmful.
Objective
To test the hypothesis that room air is noninferior to oxygen in improving fetal metabolic status among patients with category II fetal heart tracings.
Design, Setting, and Participants
This was a randomized, unblinded noninferiority clinical trial conducted between June 2016 and July 2017 in the labor and delivery ward of a single tertiary care center. Women with singleton pregnancies at 37 weeks' gestational age or more who were admitted for delivery were eligible. Of those who met inclusion criteria, the patients who developed category II tracings in labor that necessitated intrauterine resuscitation were randomized in a 1:1 ratio to room air or oxygen. Analyses were intention-to-treat.
Interventions
The oxygen group received 10 L of oxygen per minute by nonrebreather facemask until delivery. The room air group was exposed to room air only without a facemask.
Main Outcomes and Measures
The primary outcome was umbilical artery lactate, a marker of metabolic acidosis and neonatal morbidity. Noninferiority was defined as a mean difference between groups of less than 9.0 mg/dL (1.0 mmol/L). Secondary outcomes were other umbilical artery gases, cesarean delivery for nonreassuring fetal status, and operative vaginal delivery.
Results
Of the 705 patients who met inclusion criteria, 277 (39.3%) were enrolled on admission. During labor, 114 patients (41.2% of the enrolled patients) developed category II tracings and were randomized to room air (57 patients; 50.0% of the randomized patients) or oxygen (57 patients; 50.0% of the randomized patients). A total of 99 patients (86.8% of the randomized patients) with paired cord gases were included in the modified intention-to-treat analysis. The 99 patients included 76 African American women (77%); mean (SD) age was 27.3 (6.3) years in the oxygen group and 27.8 (5.3) years in the room air group. There was no difference in umbilical artery lactate between the group on oxygen and the group on room air (mean, 30.6 mg/dL [95% CI, 27.0 to 34.2 mg/dL] vs 31.5 mg/dL [95% CI, 27.9 to 36.0 mg/dL]); P = .69). The mean difference in lactate was 0.9 mg/dL (95% CI, -4.5 to 6.3 mg/dL), which was within the noninferiority margin. There was no difference in other umbilical artery gas components or mode of delivery between groups.
Conclusions and Relevance
Among patients with category II fetal heart tracings, intrauterine resuscitation with room air is noninferior to oxygen in improving umbilical artery lactate. The results of this trial challenge the efficacy of a ubiquitous obstetric practice and suggest that room air may be an acceptable alternative.
Trial Registration
ClinicalTrials.gov Identifier: NCT02741284.",2018,"There was no difference in umbilical artery lactate between the group on oxygen and the group on room air (mean, 30.6 mg/dL [95% CI, 27.0 to 34.2 mg/dL] vs 31.5 mg/dL","['114 patients (41.2% of the enrolled patients) developed category II tracings', '99 patients included 76 African American women (77%); mean (SD) age was 27.3 (6.3) years in the oxygen group and 27.8 (5.3) years in the room air group', 'patients who developed category II tracings in labor that necessitated intrauterine resuscitation', '99 patients (86.8% of the randomized patients) with paired cord gases were included in the modified intention-to-treat analysis', 'Intrauterine Fetal Resuscitation', 'patients with category II fetal heart tracings', 'June 2016 and July 2017 in the labor and delivery ward of a single tertiary care center', ""Women with singleton pregnancies at 37 weeks' gestational age or more who were admitted for delivery were eligible"", '705 patients who met inclusion criteria, 277 (39.3%) were enrolled on admission']","['dL', '10 L of oxygen per minute by nonrebreather facemask until delivery', 'Oxygen vs Room Air']","['mean difference in lactate', 'umbilical artery lactate, a marker of metabolic acidosis and neonatal morbidity', 'fetal hypoxemia and prevent acidemia', 'umbilical artery lactate', 'umbilical artery gas components or mode of delivery', 'fetal metabolic status', 'umbilical artery gases, cesarean delivery for nonreassuring fetal status, and operative vaginal delivery']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0015935', 'cui_str': 'Fetal Heart'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0457453', 'cui_str': 'On admission (qualifier value)'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0041632', 'cui_str': 'Umbilical Arteries'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0268030', 'cui_str': 'Acidemia (disorder)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0015930', 'cui_str': 'Nonreassuring Fetal Status'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}]",99.0,0.179573,"There was no difference in umbilical artery lactate between the group on oxygen and the group on room air (mean, 30.6 mg/dL [95% CI, 27.0 to 34.2 mg/dL] vs 31.5 mg/dL","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Leping', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Lorene A', 'Initials': 'LA', 'LastName': 'Temming', 'Affiliation': 'Department of Obstetrics and Gynecology, Carolinas Medical Center, Charlotte, North Carolina.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Woolfolk', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine in St Louis, St Louis, Missouri.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2018.1208']
718,31863182,Maternal personality traits moderate treatment response in the Multimodal Treatment Study of attention-deficit/hyperactivity disorder.,"Some mothers of children with attention-deficit/hyperactivity disorder (ADHD) present with maladaptive personality profiles (high neuroticism, low conscientiousness). The moderating effect of maternal personality traits on treatment outcomes for childhood ADHD has not been examined. We evaluate whether maternal neuroticism and conscientiousness moderated response in the Multimodal Treatment Study of Children with ADHD. This is one of the first studies of this type. In a randomized controlled trial (RCT), 579 children aged 7-10 (M = 8.5); 19.7% female; 60.8% White with combined-type ADHD were randomly assigned to systematic medication management (MedMgt) alone, comprehensive multicomponent behavioral treatment (Beh), their combination (Comb), or community comparison treatment-as-usual (CC). Latent class analysis and linear mixed effects models included 437 children whose biological mothers completed the NEO Five-Factor Inventory at baseline. A 3-class solution demonstrated best fit for the NEO: MN&MC = moderate neuroticism and conscientiousness (n = 284); HN&LC = high neuroticism, low conscientiousness (n = 83); LN&HC = low neuroticism, high conscientiousness (n = 70). Per parent-reported symptoms, children of mothers with HN&LC, but not LN&HC, had a significantly better response to Beh than to CC; children of mothers with MN&MC and LN&HC, but not HN&LC, responded better to Comb&MedMgt than to Beh&CC. Per teacher-reported symptoms, children of mothers with HN&LC, but not LN&HC, responded significantly better to Comb than to MedMgt. Children of mothers with high neuroticism and low conscientiousness benefited more from behavioral treatments (Beh vs. CC; Comb vs. MedMgt) than other children. Evaluation of maternal personality may aid in treatment selection for children with ADHD, though additional research on this topic is needed.",2020,"Per teacher-reported symptoms, children of mothers with HN&LC, but not LN&HC, responded significantly better to Comb than to MedMgt.","['attention-deficit/hyperactivity disorder', '579 children aged 7-10 (M\u2009=\u20098.5); 19.7% female; 60.8% White with combined-type ADHD', 'Some mothers of children with attention-deficit/hyperactivity disorder (ADHD', 'children with ADHD', '437 children whose biological mothers completed the NEO Five-Factor Inventory at baseline', 'Children with ADHD', 'Children of mothers with high neuroticism and low conscientiousness']","['systematic medication management (MedMgt) alone, comprehensive multicomponent behavioral treatment (Beh), their combination (Comb), or community comparison treatment-as-usual (CC']",[],"[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0337486', 'cui_str': 'Natural mother (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],579.0,0.0308211,"Per teacher-reported symptoms, children of mothers with HN&LC, but not LN&HC, responded significantly better to Comb than to MedMgt.","[{'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Perez Algorta', 'Affiliation': 'LA14YG, Lancaster University, Furness C73, Lancaster, UK. g.perezalgorta@lancaster.ac.uk.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'MacPherson', 'Affiliation': 'Brown University, Providence, RI, USA.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hinshaw', 'Affiliation': 'University of California, Berkeley, CA, USA.'}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Hechtman', 'Affiliation': 'McGill University, Montreal, Canada.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Owens', 'Affiliation': 'University of California, Berkeley, CA, USA.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01460-z']
719,31624440,Efficacy of Feracrylum as Topical Hemostatic Agent in Therapeutically Anticoagulated Patients Undergoing Dental Extraction: A Comparative Study.,"Aims and Objective
To compare the efficacy of feracrylum with tranexamic acid (TXA), following dental extraction in patients who are therapeutically anticoagulated with warfarin.
Study Design
Sixty patients on warfarin were randomly divided into three groups. Groups 1 and 2 patients were given feracrylum (1%), and TXA (5%) solution pressure pack and a control group (Group 3) was given normal saline (NS) pressure pack after extraction. Postoperative bleeding was assessed and graded numerically and periodically (0, 1, 2, 5 and 7 days). The values were statistically analyzed.
Results
Sixty patients (M:F::37:23) with a mean age of 56 years who were therapeutically anticoagulated for different medical conditions were included. The mean warfarin dosage was 3.5 mg, and the mean INR was 2.83. Out of 27 patients who showed bleeding on day of extraction, eight, ten and nine patients belonged to groups I, II and III, respectively, and the difference was nonsignificant. Out of 15 patients who showed bleeding on post-extraction day 1, one, five and nine patients belonged to groups I, II and III, respectively. The difference was statistically significant on day 1 and nonsignificant in the next follow-ups.
Conclusion
Local hemostatic agents like TXA and feracrylum arrest bleeding without having any systemic action and without the necessity of altering the anticoagulant regimen. Feracrylum has an added advantage of a single application, formation of a mechanical barrier and an additional antimicrobial effect. These agents should be incorporated in the protocol for managing patients on oral anticoagulants.",2019,"Conclusion
Local hemostatic agents like TXA and feracrylum arrest bleeding without having any systemic action and without the necessity of altering the anticoagulant regimen.","['Sixty patients on', 'Therapeutically Anticoagulated Patients Undergoing Dental Extraction', 'patients who are therapeutically anticoagulated with warfarin', 'Sixty patients (M:F::37:23) with a mean age of 56\xa0years who were therapeutically anticoagulated for different medical conditions were included']","['TXA (5%) solution pressure pack and a control group (Group 3) was given normal saline (NS) pressure pack after extraction', 'tranexamic acid (TXA', 'Feracrylum', 'warfarin']","['Postoperative bleeding', 'mean warfarin dosage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]",60.0,0.0222605,"Conclusion
Local hemostatic agents like TXA and feracrylum arrest bleeding without having any systemic action and without the necessity of altering the anticoagulant regimen.","[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Rai', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012 India.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Rattan', 'Affiliation': 'Unit of Oral and Maxillofacial Surgery, Oral Health Sciences Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-018-1156-6']
720,29939055,Measuring fear change within exposures: Functionally-defined habituation predicts outcome in three randomized controlled trials for pediatric OCD.,"OBJECTIVE
This study measured a variety of within-exposure fear changes and tested the relationship of each with treatment outcomes in exposure therapy.
METHOD
We coded 459 videotaped exposure tasks from 111 participants in 3 clinical trials for pediatric obsessive-compulsive disorder (OCD; POTS trials). Within exposures, fear level was observed continuously and alongside exposure process. Fear change metrics of interest were selected for relevance to mechanistic theory. Fear decreases were classified by function; nonhabituation decreases were associated with observed nonlearning processes (e.g., avoidance), whereas habituation decreases appeared to result from an internal and indirect process. Outcomes were posttreatment change in symptom severity, global improvement, and treatment response.
RESULTS
Greater cumulative habituation across treatment was associated with larger reductions in symptom severity, greater global improvement, and increased odds of treatment response. Fear activation, fear variability, and nonhabituation fear decreases did not predict any outcomes. Exploratory analyses examined fear changes during habituation and nonhabituation exposures; higher peak fear during nonhabituation exposures was associated with attenuated global improvement.
CONCLUSIONS
Habituation is conceptually consistent with multiple mechanistic theories and should continue to be investigated as a practical marker of initial extinction learning and possible moderator of the relationship between fear activation and outcome. Results support the importance of functional and frequent fear measurement during exposures, and discussion considers implications of these findings for future studies aiming to understand learning during exposure and improve exposure delivery. (PsycINFO Database Record",2018,"Exploratory analyses examined fear changes during habituation and nonhabituation exposures; higher peak fear during nonhabituation exposures was associated with attenuated global improvement.
",['111 participants in 3 clinical trials for pediatric obsessive-compulsive disorder (OCD; POTS trials'],[],"['symptom severity, greater global improvement, and increased odds of treatment response', 'symptom severity, global improvement, and treatment response', 'fear level', 'cumulative habituation', 'Fear activation, fear variability, and nonhabituation fear decreases']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}]",[],"[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",111.0,0.0269518,"Exploratory analyses examined fear changes during habituation and nonhabituation exposures; higher peak fear during nonhabituation exposures was associated with attenuated global improvement.
","[{'ForeName': 'Kristen G', 'Initials': 'KG', 'LastName': 'Benito', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Machan', 'Affiliation': 'Lifespan Biostatistics Core, Lifespan Hospitals.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Abbe M', 'Initials': 'AM', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walther', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Temple University.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Wellen', 'Affiliation': 'Department of Psychology, University of Utah.'}, {'ForeName': 'Elyse', 'Initials': 'E', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology, State University of New York at Binghamton.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Edmunds', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kemp', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sapyta', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical School.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Franklin', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000315']
721,31624435,Are Bondable Buttons a Better Option than Intermaxillary Fixation Screws for Achieving Maxillomandibular Fixation? A Prospective Randomized Clinical Study.,"Aim
The aim of this study was to identify a better option in achieving maxillomandibular fixation (MMF) comparing bondable buttons and Maxillomandibular Fixation screws in achieving Maxillomandibular Fixation.
Patients and Methods
In this randomized clinical trial, study sample was derived from the population of patients who reported with minimally displaced mandibular fractures and who required Maxillomandibular Fixation. The patients were divided into two groups. In Group I ( n = 20), Maxillomandibular Fixation was done with Maxillomandibular Fixation screws; on the other hand, in Group II ( n = 20), bondable buttons were used. In both the groups the patients were analyzed for the time duration required in minutes for securing and removal of Maxillomandibular Fixation, plaque accumulation and postoperative stability. Plaque accumulation was evaluated using TURESKY-GILMORE-GLICKMAN modification of the Quigley-Hein plaque index. The complications encountered during and after the surgery were also analyzed.
Results
The plaque accumulation and time required for placement and removal in group I were more as compared to group II. In Group I, there were more complications as compared to Group II such as tooth root damage, screw loosening, screw breakage and infection.
Conclusion
Bondable buttons are a better choice for achieving Maxillomandibular Fixation in comparison with Maxillomandibular Fixation screws for the treatment of minimally displaced mandibular fractures. Further studies with a bigger sample size must be carried out.",2019,"In Group I, there were more complications as compared to Group II such as tooth root damage, screw loosening, screw breakage and infection.
","['population of patients who reported with minimally displaced mandibular fractures and who required\xa0Maxillomandibular Fixation', 'minimally displaced mandibular fractures']","['Maxillomandibular Fixation screws', 'Intermaxillary Fixation Screws', 'Maxillomandibular Fixation was done with Maxillomandibular Fixation screws', 'maxillomandibular fixation (MMF) comparing bondable buttons and Maxillomandibular Fixation screws']","['Plaque accumulation', 'time duration required in minutes\xa0for securing and removal of\xa0Maxillomandibular Fixation, plaque accumulation and postoperative stability', 'tooth root damage, screw loosening, screw breakage and infection', 'plaque accumulation and time required for placement and removal']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}, {'cui': 'C0376509', 'cui_str': 'Maxillomandibular Fixation'}]","[{'cui': 'C0376509', 'cui_str': 'Maxillomandibular Fixation'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0453985', 'cui_str': 'Button, device (physical object)'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0376509', 'cui_str': 'Maxillomandibular Fixation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040452', 'cui_str': 'Tooth Root'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0333050', 'cui_str': 'Loosening (morphologic abnormality)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.0228381,"In Group I, there were more complications as compared to Group II such as tooth root damage, screw loosening, screw breakage and infection.
","[{'ForeName': 'Anshul', 'Initials': 'A', 'LastName': 'Rai', 'Affiliation': '1Department of Dentistry, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh India.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': '2Department of Trauma and Emergency Medicine, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Datarkar', 'Affiliation': '3Department of Oral and Maxillofacial Surgery, Government Dental College, Nagpur, Maharashtra India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Purohit', 'Affiliation': '3Department of Oral and Maxillofacial Surgery, Government Dental College, Nagpur, Maharashtra India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01238-5']
722,31624438,Gap Arthroplasty or Interpositional Arthroplasty for the Management of TMJ Ankylosis? A Prospective Randomized Comparative Multicenter Clinical Trial.,"Aim
The main aim of this study is to compare the gap arthroplasty with interpositional gap arthroplasty for the management of TMJ ankylosis.
Methodology
A prospective randomized multicenter clinical trial had been performed, on 60 patients diagnosed with TMJ ankylosis from August 2005 to June 2015. Patients were equally divided into two groups: Group I patients were treated with gap arthroplasty, while patients in Group II were treated with interpositional arthroplasty.
Results
The mean age in Group I was 27.9 years and in Group II was 25.6 years. Trauma was the common etiological factor in both the groups. The mean postoperative mouth opening after 1 month, 6 months and 24 months was found to better in Group II. Open bite after 24 months was present in six patients in Group I and in one case in Group II. Permanent facial nerve palsy was present in one patient in both the groups. Frey's syndrome was present in one patient from Group I and none from Group II. Reoccurrence occurred in eight cases from Group I (26.6%) and none from Group II.
Conclusion
This study concluded that interpositional arthroplasty is better than gap arthroplasty in terms of mouth opening and reankylosis.",2019,This study concluded that interpositional arthroplasty is better than gap arthroplasty in terms of mouth opening and reankylosis.,['60 patients diagnosed with TMJ ankylosis from August 2005 to June 2015'],"['gap arthroplasty with interpositional gap arthroplasty', 'gap arthroplasty', 'interpositional arthroplasty', 'Gap Arthroplasty or Interpositional Arthroplasty']","['Permanent facial nerve palsy', 'Reoccurrence', 'mean postoperative mouth opening']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}]","[{'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0015462', 'cui_str': 'Nervus Facialis'}, {'cui': 'C0522224', 'cui_str': 'Plegia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]",,0.0292996,This study concluded that interpositional arthroplasty is better than gap arthroplasty in terms of mouth opening and reankylosis.,"[{'ForeName': 'Shallu', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': '1Department of Oral and Maxillofacial Surgery, Surendera Dental College and Research Institute, H. H. Garden, Power House Road, Sriganganagar, Rajasthan 335001 India.'}, {'ForeName': 'Dinesh Kumar', 'Initials': 'DK', 'LastName': 'Verma', 'Affiliation': '1Department of Oral and Maxillofacial Surgery, Surendera Dental College and Research Institute, H. H. Garden, Power House Road, Sriganganagar, Rajasthan 335001 India.'}, {'ForeName': 'Manjunath', 'Initials': 'M', 'LastName': 'Rai', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, AJ Institute of Dental Sciences, Mangalore, Karnataka India.'}, {'ForeName': 'Abhinay', 'Initials': 'A', 'LastName': 'Sorake', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopedics, AJ Institute of Dental Sciences, Mangalore, Karnataka India.'}, {'ForeName': 'Charanpreet', 'Initials': 'C', 'LastName': 'Kaur', 'Affiliation': '1Department of Oral and Maxillofacial Surgery, Surendera Dental College and Research Institute, H. H. Garden, Power House Road, Sriganganagar, Rajasthan 335001 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-018-1150-z']
723,29888939,Working memory updating and binding training: Bayesian evidence supporting the absence of transfer.,"As working memory (WM) predicts a wide range of other abilities, it has become a popular target for training interventions. However, its effectiveness to elicit generalized cognitive benefits is still under debate. Previous research yielded inconsistent findings and focused only little on the mechanisms underlying transfer effects. To disentangle training effects on WM capacity and efficiency, we evaluated near transfer to untrained, structurally different WM tasks and far transfer to closely related abilities (i.e., reasoning, processing speed, task switching, and inhibitory control) in addition to process-specific effects on 3 WM mechanisms (i.e., focus switching, removal of WM contents, and interference resolution). We randomly assigned 197 young adults to 1 of 2 experimental groups (updating or item-to-context binding) or to an active control group practicing visual search tasks. Before and after 5 weeks of adaptive training, performance was assessed measuring each of the cognitive processes and abilities of interest with 4 tasks covering verbal-numerical and visual-spatial materials. Despite the relatively large sample size, large practice effects in the trained tasks, and at least moderate correlations between WM training tasks and transfer measures, we found consistent evidence for the absence of any training-induced improvements across all ranges of transfer and mechanisms. Instead, additional analyses of error patterns and self-reported strategy use indicated that WM training encouraged the development of stimulus-specific expertise and use of paradigm-specific strategies. Thus, the results suggest that the WM training interventions examined here enhanced neither WM capacity nor the WM mechanisms assumed to underlie transfer. (PsycINFO Database Record",2018,"Before and after 5 weeks of adaptive training, performance was assessed measuring each of the cognitive processes and abilities of interest with 4 tasks covering verbal-numerical and visual-spatial materials.",['197 young adults to 1 of 2 experimental groups (updating or'],"['Working memory updating and binding training', 'item-to-context binding) or to an active control group practicing visual search tasks']",['WM capacity and efficiency'],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0449255', 'cui_str': 'Context (attribute)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}]",197.0,0.0329382,"Before and after 5 weeks of adaptive training, performance was assessed measuring each of the cognitive processes and abilities of interest with 4 tasks covering verbal-numerical and visual-spatial materials.","[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'De Simoni', 'Affiliation': 'Department of Psychology, University of Zurich.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'von Bastian', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. General,['10.1037/xge0000453']
724,31624448,Vazirani-Akinosi Nerve Block Technique: An Asset of Oral and Maxillofacial Surgeon.,"Background
Vazirani-Akinosi nerve block technique is an established and a reliable technique to achieve anaesthesia in mandible with high success rate and is useful in cases where Halstead's technique fails to provide desired anaesthetic effect.
Materials and Methods
A total of 140 ASA-I or ASA-II patients, both genders, between 16 and 45 years who required extraction of mandibular tooth were divided into two groups. Group A received nerve block through Halstead technique, while Group B received nerve block through Vazirani-Akinosi technique with 2% lignocaine containing 1:200,000 adrenaline. We evaluated the subjective and objective onset of anaesthesia, outcome of the injection, outcome of the aspiration and patient satisfaction.
Results
In Group A, the altered sensation was experienced at 68.70 s, while in Group B it was 92.55 s and the difference was statistically highly significant ( p < 0.001) between the two groups. The mean onset of anaesthesia (measured with Electric pulp tester) in Group A was 78.36 s, while for Group B it was 104.24 s and this difference was statistically highly significant ( p < 0.001). Positive aspiration was seen in 11 (15.71%) patients in Group A and in 2 (2.86%) patients in Group B. The success rate for Group A was 81.42% and for Group B it was 97.14%.
Conclusion
Vazirani-Akinosi technique provides desirable surgical anaesthesia with relatively high success rate and lower incidence of positive aspiration and can be considered as a boon for oral and maxillofacial surgeons.",2019,Positive aspiration was seen in 11 (15.71%) patients in Group A and in 2 (2.86%) patients in Group B.,"['A total of 140 ASA-I or ASA-II patients, both genders, between 16 and 45\xa0years who required extraction of mandibular tooth']","['Vazirani-Akinosi technique', 'nerve block through Halstead technique, while Group B received nerve block through Vazirani-Akinosi technique with 2% lignocaine containing 1:200,000 adrenaline', 'Vazirani-Akinosi Nerve Block Technique', '\n\n\nVazirani-Akinosi nerve block technique']","['mean onset of anaesthesia', 'success rate', 'altered sensation', 'Positive aspiration']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0227029', 'cui_str': 'Structure of mandibular teeth'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0423575', 'cui_str': 'Altered sensation of skin (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}]",140.0,0.0480433,Positive aspiration was seen in 11 (15.71%) patients in Group A and in 2 (2.86%) patients in Group B.,"[{'ForeName': 'Shoeb Kasim', 'Initials': 'SK', 'LastName': 'Jendi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Yogita Dental College and Hospital, Naringi Riverside, Dapoli Road, Khed, Ratnagiri, Maharashtra India.'}, {'ForeName': 'Bibin George', 'Initials': 'BG', 'LastName': 'Thomas', 'Affiliation': 'Department of Periodontology, Yogita Dental College and Hospital, Naringi Riverside, Dapoli Road, Khed, Ratnagiri, Maharashtra India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01183-3']
725,29683690,Call to claim your prize: Perceived benefits and risk drive intention to comply in a mass marketing scam.,"Mass marketing scams extract an enormous toll, yet the literature on scams is just emerging. In Experiment 1, 211 adults reviewed a solicitation and rated their intention of contacting an ""activation number"" for a prize. Scarcity and authority were manipulated. Many (48.82%) indicated some willingness to contact to ""activate"" the winnings. Intention of responding was inversely related to the perception of risk (b = -.441, p < .001) and positively associated with perception of benefits (b = .554, p < .001), but not with the experimental condition. In Experiment 2, 291 adults were randomly assigned to one of the three conditions (low, medium, or high activation fee), and were asked to report willingness to contact. Activation fees decreased intent to contact, but percentages remained high (25.70%), with higher perception of risk reducing contact rates (b = -.581, p < .001), and benefit perception increasing intent to contact (b = .381, p < .001). Our studies indicate that consumers are responding to perceived risks and benefits in their decision-making, regardless of persuasion elements used by scammers. In summary, our studies find that consumers with lower levels of education and high perception of benefits are at increased risk for mass marketing scams. (PsycINFO Database Record",2018,"Activation fees decreased intent to contact, but percentages remained high (25.70%), with higher perception of risk reducing contact rates (b = -.581, p < .001), and benefit perception increasing intent to contact (b = .381, p < .001).","['211 adults reviewed a solicitation and rated their intention of contacting an ""activation number"" for a prize', '291 adults']",[],['higher perception of risk reducing contact rates'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0080049', 'cui_str': 'Prizes'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",291.0,0.0245097,"Activation fees decreased intent to contact, but percentages remained high (25.70%), with higher perception of risk reducing contact rates (b = -.581, p < .001), and benefit perception increasing intent to contact (b = .381, p < .001).","[{'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Wood', 'Affiliation': 'Department of Psychology, Scripps College.'}, {'ForeName': 'Pi-Ju', 'Initials': 'PJ', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, University of California, San Francisco.'}, {'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Hanoch', 'Affiliation': 'Department of Psychology, University of Plymouth.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Xi', 'Affiliation': 'Department of Psychology, Claremont Graduate University.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Klapatch', 'Affiliation': 'Department of Psychology, Claremont Graduate University.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000167']
726,29781659,"Nicotine deprivation increases pain intensity, neurogenic inflammation, and mechanical hyperalgesia among daily tobacco smokers.","An evolving reciprocal model posits that pain and tobacco smoking behavior interact in the manner of a positive feedback loop, resulting in greater pain and the maintenance of nicotine dependence. There is also reason to believe that abstaining from smoking may increase pain during the early stages of smoking cessation. The goal of this study was to test the effects of nicotine deprivation on experimental pain reactivity. Daily tobacco cigarette smokers (N = 165; 43% female) were randomized to either extended nicotine deprivation (12-24 hr smoking abstinence), minimal deprivation (2 hr smoking abstinence), or continued smoking conditions, prior to undergoing pain induction via topical capsaicin. As hypothesized, results indicated that extended deprivation (relative to continued smoking) increased capsaicin-induced pain intensity ratings, neurogenic inflammation, and mechanical hyperalgesia, thus implicating both central and peripheral mechanisms of action in the effects of smoking abstinence on pain reactivity. Pain intensity ratings were also positively correlated with nicotine withdrawal symptoms, and exploratory analyses suggest that pain sensitivity may increase with duration of smoking abstinence. Collectively, these findings indicate that smokers may experience a variety of negative pain-related sequelae during the early stages of a quit attempt. Future research should examine pain as a consequence or correlate of the nicotine withdrawal syndrome, and determine whether smokers may benefit from tailored cessation interventions that account for nicotine deprivation-induced amplification of pain. (PsycINFO Database Record",2018,"Pain intensity ratings were also positively correlated with nicotine withdrawal symptoms, and exploratory analyses suggest that pain sensitivity may increase with duration of smoking abstinence.","['daily tobacco smokers', 'Daily tobacco cigarette smokers (N = 165; 43% female']","['nicotine deprivation', 'Nicotine deprivation', 'extended nicotine deprivation (12-24 hr smoking abstinence), minimal deprivation (2 hr smoking abstinence), or continued smoking conditions, prior to undergoing pain induction via topical capsaicin']","['pain reactivity', 'experimental pain reactivity', 'pain', 'duration of smoking abstinence', 'capsaicin-induced pain intensity ratings, neurogenic inflammation, and mechanical hyperalgesia', 'pain intensity, neurogenic inflammation, and mechanical hyperalgesia', 'Pain intensity ratings']","[{'cui': 'C3266136', 'cui_str': 'Daily tobacco smoker'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0600467', 'cui_str': 'Neurogenic Inflammation'}, {'cui': 'C2936719', 'cui_str': 'Mechanical Allodynia'}]",,0.0280507,"Pain intensity ratings were also positively correlated with nicotine withdrawal symptoms, and exploratory analyses suggest that pain sensitivity may increase with duration of smoking abstinence.","[{'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Ditre', 'Affiliation': 'Department of Psychology, Syracuse University.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Zale', 'Affiliation': 'Department of Psychology, Syracuse University.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'LaRowe', 'Affiliation': 'Department of Psychology, Syracuse University.'}, {'ForeName': 'Jesse D', 'Initials': 'JD', 'LastName': 'Kosiba', 'Affiliation': 'Department of Psychology, Syracuse University.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'De Vita', 'Affiliation': 'Department of Psychology, Syracuse University.'}]",Journal of abnormal psychology,['10.1037/abn0000353']
727,31557064,Neoadjuvant Modified FOLFOX6 With or Without Radiation Versus Fluorouracil Plus Radiation for Locally Advanced Rectal Cancer: Final Results of the Chinese FOWARC Trial.,"PURPOSE
In the multicenter, open-label, phase III FOWARC trial, modified infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy resulted in a higher pathologic complete response rate than fluorouracil plus radiotherapy in Chinese patients with locally advanced rectal cancer. Here, we report the final results.
METHODS
Adults ages 18 to 75 years with stage II/III rectal cancer were randomly assigned (1:1:1) to five cycles of infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2 over 48 hours) plus radiotherapy (46.0 to 50.4 Gy delivered in 23 to 25 fractions during cycles 2 to 4) followed by surgery and seven cycles of infusional fluorouracil, the same treatment plus intravenous oxaliplatin 85 mg/m 2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6. The primary end point was 3-year disease-free survival (DFS).
RESULTS
In total, 495 patients were randomly assigned to treatment. After a median follow-up of 45.2 months, DFS events were reported in 46, 39, and 46 patients in the fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy, and mFOLFOX6 arms. In each arm, the probability of 3-year DFS was 72.9%, 77.2%, and 73.5% ( P = .709 by the log-rank test), the 3-year probability of local recurrence after R0/1 resection was 8.0%, 7.0%, and 8.3% ( P = .873 by the log-rank test), and the 3-year overall survival rate was 91.3%, 89.1%, and 90.7% ( P = .971 by log-rank test), respectively.
CONCLUSION
mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer. No significant difference in outcomes was found between mFOLFOX6 without radiotherapy and fluorouracil with radiotherapy, which requires additional investigation of the role of radiotherapy in these regimens.",2019,"CONCLUSION
mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","['Locally Advanced Rectal Cancer', 'Adults ages 18 to 75 years with stage II/III rectal cancer', 'patients with locally advanced rectal cancer', '495 patients', 'Chinese patients with locally advanced rectal cancer']","['fluorouracil with radiotherapy', 'fluorouracil with radiation', 'fluorouracil plus radiotherapy, mFOLFOX6 plus radiotherapy', 'infusional fluorouracil (leucovorin 400 mg/m 2 , fluorouracil 400 mg/m 2 , and fluorouracil 2.4 g/m 2 over 48 hours) plus radiotherapy', 'infusional fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) plus radiotherapy', 'fluorouracil plus radiotherapy', 'Without Radiation Versus Fluorouracil Plus Radiation', 'infusional fluorouracil', 'oxaliplatin 85 mg/m 2 on day 1 of each cycle (mFOLFOX6), or four to six cycles of mFOLFOX6 followed by surgery and six to eight cycles of mFOLFOX6', 'Neoadjuvant Modified FOLFOX6']","['3-year overall survival rate', 'probability of 3-year DFS', '3-year probability of local recurrence', '3-year DFS', '3-year disease-free survival (DFS', 'DFS events']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",495.0,0.0663218,"CONCLUSION
mFOLFOX6, with or without radiation, did not significantly improve 3-year DFS versus fluorouracil with radiation in patients with locally advanced rectal cancer.","[{'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': ""Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lan', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiqing', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""School of Public Health, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ""Xinhua Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Daoda', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Xiehe Hospital, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': ""The First People's Hospital, Guangzhou City, People's Republic of China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ""The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""The First People's Hospital, Foshan City, People's Republic of China.""}, {'ForeName': 'Zonghai', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Zhujiang Hospital, Nanfang University of Medical Science, Guangzhou, People's Republic of China.""}, {'ForeName': 'Guanfu', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': ""Guangdong Provincial Peoples Hospital, Guangzhou, People's Republic of China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhao', 'Affiliation': ""Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Zhongcheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""General Hospital, Hunan Province, Changsha, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""The First Affiliated Hospital, Xiamen University, Xiamen, People's Republic of China.""}, {'ForeName': 'Hongfeng', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Guangzhou General Hospital of Guangzhou Military Command, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': ""The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Xinhua Hospital, Dongguan, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhiyang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Kang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Meijin', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Xiaojian', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Ren', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The Sixth Affiliated Hospital, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Disease, Guangzhou, People's Republic of China.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.02309']
728,29685792,"Genomic Response to Vitamin D Supplementation in the Setting of a Randomized, Placebo-Controlled Trial.","BACKGROUND
Vitamin D deficiency has been associated with multiple diseases, but the causal relevance and underlying processes are not fully understood. Elucidating the mechanisms of action of drug treatments in humans is challenging, but application of functional genomic approaches in randomized trials may afford an opportunity to systematically assess molecular responses.
METHODS
In the Biochemical Efficacy and Safety Trial of Vitamin D (BEST-D), a double-blind, placebo-controlled, dose-finding, randomized clinical trial, 305 community-dwelling individuals aged over 65 years were randomly allocated to treatment with vitamin D 3 4000 IU, 2000 IU or placebo daily for 12 months. Genome-wide genotypes at baseline, and transcriptome and plasma levels of cytokines (IFN-γ, IL-10, IL-8, IL-6 and TNF-α) at baseline and after 12 months, were measured. The trial had >90% power to detect 1.2-fold changes in gene expression.
FINDINGS
Allocation to vitamin D for 12-months was associated with 2-fold higher plasma levels of 25-hydroxy-vitamin D (25[OH]D, 4000 IU regimen), but had no significant effect on whole-blood gene expression (FDR < 5%) or on plasma levels of cytokines compared with placebo. In pre-specified analysis, rs7041 (intron variant, GC) had a significant effect on circulating levels of 25(OH)D in the low dose, but not in the placebo or high dose vitamin D regimen. A gene expression quantitative trait locus analysis (eQTL) demonstrated evidence of 31,568 cis-eQTLs (unique SNP-probe pairs) among individuals at baseline and 34,254 after supplementation for 12 months (any dose). No significant associations involving vitamin D supplementation response eQTLs were found.
INTERPRETATION
We performed a comprehensive functional genomics and molecular analysis of vitamin D supplementation in a randomized, placebo-controlled trial. Although this study was limited to mostly Caucasian individuals aged over 65 years, the results differ from many previous studies and do not support a strong effect of vitamin D on long-term transcriptomic changes in blood or on plasma cytokine levels. The trial demonstrates the feasibility of applying functional genomic and genetic approaches in randomized trials to assess molecular and individual level responses.
KEY RESULT
Supplementation with high-dose vitamin D in older people for 12 months in a randomized, placebo-controlled trial had no significant effect on gene expression or on plasma concentrations of selected cytokines.
TRIAL REGISTRATION
SRCTN registry (Number 07034656) and the European Clinical Trials Database (EudraCT Number 2011-005763-24).",2018,"FINDINGS
Allocation to vitamin D for 12-months was associated with 2-fold higher plasma levels of 25-hydroxy-vitamin D (25[OH]D, 4000 IU regimen), but had no significant effect on whole-blood gene expression (FDR < 5%) or on plasma levels of cytokines compared with placebo.","['mostly Caucasian individuals aged over 65\u202fyears', '305 community-dwelling individuals aged over 65\u202fyears', 'older people for 12\u202fmonths']","['vitamin D', 'Vitamin D (BEST-D', 'vitamin D supplementation', 'placebo', 'Placebo', 'Vitamin D Supplementation', 'Supplementation with high-dose vitamin D', 'vitamin D 3 4000\u202fIU, 2000\u202fIU or placebo']","['transcriptome and plasma levels of cytokines (IFN-γ, IL-10, IL-8, IL-6 and TNF-α', 'plasma levels of cytokines', 'whole-blood gene expression', 'circulating levels of 25(OH)D', 'plasma levels of 25-hydroxy-vitamin D', 'vitamin D supplementation response eQTLs', 'gene expression or on plasma concentrations of selected cytokines']","[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C3178810', 'cui_str': 'Transcriptome'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",305.0,0.761058,"FINDINGS
Allocation to vitamin D for 12-months was associated with 2-fold higher plasma levels of 25-hydroxy-vitamin D (25[OH]D, 4000 IU regimen), but had no significant effect on whole-blood gene expression (FDR < 5%) or on plasma levels of cytokines compared with placebo.","[{'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Berlanga-Taylor', 'Affiliation': ""Computational Genomics Analysis and Training (CGAT), Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DS, UK; Wellcome Centre for Human Genetics (WHG), Nuffield Department of Medicine, University of Oxford, Roosevelt Drive, Oxford OX3 7BN, UK; MRC-PHE Centre for Environment and Health, Department of Epidemiology & Biostatistics, School of Public Health, Faculty of Medicine, Imperial College London, St Mary's Campus, Norfolk Place, London W2 1PG, UK.""}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'Plant', 'Affiliation': 'Wellcome Centre for Human Genetics (WHG), Nuffield Department of Medicine, University of Oxford, Roosevelt Drive, Oxford OX3 7BN, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dahl', 'Affiliation': 'Wellcome Centre for Human Genetics (WHG), Nuffield Department of Medicine, University of Oxford, Roosevelt Drive, Oxford OX3 7BN, UK.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Lau', 'Affiliation': 'Wellcome Centre for Human Genetics (WHG), Nuffield Department of Medicine, University of Oxford, Roosevelt Drive, Oxford OX3 7BN, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Roosevelt Drive, Oxford OX3 7LF, UK; MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Roosevelt Drive, Oxford OX3 7LF, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sims', 'Affiliation': 'Computational Genomics Analysis and Training (CGAT), Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DS, UK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Heger', 'Affiliation': 'Computational Genomics Analysis and Training (CGAT), Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, University of Oxford, Oxford OX3 9DS, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Emberson', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Roosevelt Drive, Oxford OX3 7LF, UK; MRC Population Health Research Unit, Nuffield Department of Population Health, University of Oxford, Roosevelt Drive, Oxford OX3 7LF, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Roosevelt Drive, Oxford OX3 7LF, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Clarke', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Roosevelt Drive, Oxford OX3 7LF, UK.'}, {'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Knight', 'Affiliation': 'Wellcome Centre for Human Genetics (WHG), Nuffield Department of Medicine, University of Oxford, Roosevelt Drive, Oxford OX3 7BN, UK. Electronic address: julian@well.ox.ac.uk.'}]",EBioMedicine,['10.1016/j.ebiom.2018.04.010']
729,31628863,The effectiveness of two silicone dressings for sacral and heel pressure ulcer prevention compared with no dressings in high-risk intensive care unit patients: a randomized controlled parallel-group trial.,"BACKGROUND
There is a high incidence of pressure ulcers in high-risk settings such as intensive care. There is emerging evidence that the application of dressings to pressure ulcer predilection areas (sacrum and heels) improves prevention strategies.
OBJECTIVES
To determine whether preventive dressings, applied to the sacrum and heels of high-risk patients in intensive care units, in addition to standard prevention, reduces the incidence of pressure ulcers.
METHODS
Between June 2015 and July 2018, a randomized, controlled, two-arm, superiority pragmatic study was performed with a concealed 1 : 1 allocation to the intervention and control group. Patients assigned to the intervention group had dressings applied to the sacrum and heels.
RESULTS
In total, 7575 patients were screened for eligibility and 475 patients were included and allocated to both groups. Finally, 212 patients in the intervention group and 210 in the control group were analysed. The mean age was 63·5 years and the majority of patients were male (65·4%). The cumulative pressure ulcer incidence category II and above was 2·8% in the intervention, and 10·5% in the control group (P = 0·001). Compared with the control group, the relative risk in the intervention group was 0·26 [95% confidence interval (CI) 0·11-0·62] and the absolute risk reduction was 0·08 (95% CI 0·03-0·13).
CONCLUSIONS
The results indicate that the application of dressings, in addition to standard prevention, in high-risk intensive care unit patients is effective in preventing pressure ulcers at the heels and sacrum. What's already known about this topic? Pressure ulcers are severe soft tissue injuries and wounds, which occur worldwide in all healthcare settings. Despite preventive interventions, pressure ulcers still develop. There is emerging evidence that dressings help to prevent pressure ulcers. What does this study add? The incidence of pressure ulcers in intensive care units among high-risk patients remains high. The application of dressings to the sacrum and heels, in addition to standard preventive measures, reduces the relative and absolute risks for the development of pressure ulcers. The application of preventive dressings at the heels and sacrum seems to be feasible in intensive care settings.",2020,"Compared to the control group, the relative risk in the intervention group was 0.26 (95% CI 0.11 to 0.62) and the absolute risk reduction was 0.08","['Finally, n = 212 patients in the intervention and n = 210 in the control groups were analyzed', 'In total, n = 7575 patients were screened for eligibilty, n = 475 patients', 'high risk intensive care unit patients', 'Between June 2015 and July 2018', 'Mean age was 63.5 years and the majority was male (65.4']","['silicone dressings', 'intervention group had dressings applied to sacrum and heels']","['pressure ulcers', 'absolute risk reduction', 'relative risk', 'cumulative pressure ulcer incidence category II and above']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517786', 'cui_str': '475 (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1271483', 'cui_str': 'Silicone dressing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0036037', 'cui_str': 'Sacrum'}, {'cui': 'C0018870', 'cui_str': 'Heel'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure Ulcer'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",475.0,0.0545794,"Compared to the control group, the relative risk in the intervention group was 0.26 (95% CI 0.11 to 0.62) and the absolute risk reduction was 0.08","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hahnel', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El Genedy', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tomova-Simitchieva', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hauß', 'Affiliation': 'Department of Clinical Quality and Risk Management, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stroux', 'Affiliation': 'Department of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lechner', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Richter', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Akdeniz', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Blume-Peytavi', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Löber', 'Affiliation': 'Department of Clinical Quality and Risk Management, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kottner', 'Affiliation': 'Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18621']
730,31876907,Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial.,"AIMS
To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence.
METHODS AND RESULTS
This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21-3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm.
CONCLUSION
In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected.
CLINICAL TRIAL REGISTRATION UNIQUE IDENTIFIER
NCT01813435.",2020,No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952).,"['treated patients undergoing', 'patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD']","['percutaneous coronary intervention', 'ticagrelor', 'aspirin monotherapy', 'ticagrelor monotherapy']","['2-year clinical outcomes', 'COPD and dyspnoea AE', '2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction', 'dyspnoea']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",2101.0,0.320772,No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58-1.35; P = 0.562; P int = 0.952).,"[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Spitzer', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Plante', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Hernández Antolin', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Zoltan', 'Initials': 'Z', 'LastName': 'Jambrik', 'Affiliation': 'Békés Megyei Pándy Kálmán Kórház County Hospital, Gyula, Hungary.'}, {'ForeName': 'Valeri', 'Initials': 'V', 'LastName': 'Gelev', 'Affiliation': 'Tokuda Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Cardiologie Clinique Valmy Hopital Prive Dijon Bourgogne HPDB Dijon, Dijon, France.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Konteva', 'Affiliation': 'Heart Centre ""Pontica"", Burgas, Bulgaria.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'CHU de Caen, Caen, France.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Morelle', 'Affiliation': 'Clinique St. Martin, Caen, France.'}, {'ForeName': 'Krzysztof J', 'Initials': 'KJ', 'LastName': 'Filipiak', 'Affiliation': 'First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Department of Cardiology, Erasmus Medical Centre, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rademaker-Havinga', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, The Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Cardiovascular Science, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Giessen, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT (French Alliance for Cardiovascular Trials), Université Paris Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway, Galway, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz052']
731,31933586,Emulsion of Olive Oil and Calcium Hydroxide for the Prevention of Radiation Dermatitis in Hypofractionation Post-Mastectomy Radiotherapy: A Randomized Controlled Trial.,"Background
Most of the patients who have been treated by post-mastectomy radiotherapy (PMRT) experience skin toxicity. There have been few studies on acute radiation dermatitis in breast cancer patients who received hypofractionation PMRT.
Methods
62 patients were randomized to receive a general skin care regimen with or without the addition of an emulsion of olive oil and calcium hydroxide twice a day, from the initiation of PMRT to 2 weeks after radiotherapy. Adverse skin reactions and the Skindex-16 score were assessed.
Results
At the 8th, 13th, and 16th fraction of PMRT, grade 1 dermatitis was found in 42, 90, and 90% of the control group and in 16, 30, and 71% of the intervention group. At the end of the study, the mean Skindex-16 score of the intervention group was significantly better than that of the control group (p = 0.019).
Conclusions
Addition of an emulsion of olive oil and calcium hydroxide for patients undergoing hypofractionation PMRT yielded superior preventive results over a general skin care regimen alone, in terms of delaying skin toxicity, reducing the severity of acute radiation dermatitis, and a better quality of life in the intervention group. However, a larger number of patients will be required to confirm this result.",2019,"At the end of the study, the mean Skindex-16 score of the intervention group was significantly better than that of the control group (p = 0.019).
","['breast cancer patients who received hypofractionation PMRT', '62 patients', 'patients who have been treated by post-mastectomy radiotherapy (PMRT) experience skin toxicity']","['general skin care regimen with or without the addition of an emulsion of olive oil and calcium hydroxide', 'Emulsion of Olive Oil and Calcium Hydroxide', 'emulsion of olive oil and calcium hydroxide', 'Hypofractionation Post-Mastectomy Radiotherapy']","['PMRT, grade 1 dermatitis', 'quality of life', 'severity of acute radiation dermatitis', 'mean Skindex-16 score', 'Adverse skin reactions and the Skindex-16 score', 'skin toxicity']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4720919', 'cui_str': 'Post-mastectomy radiotherapy (procedure)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C4720919', 'cui_str': 'Post-mastectomy radiotherapy (procedure)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0034380'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}]",62.0,0.0506453,"At the end of the study, the mean Skindex-16 score of the intervention group was significantly better than that of the control group (p = 0.019).
","[{'ForeName': 'Imjai', 'Initials': 'I', 'LastName': 'Chitapanarux', 'Affiliation': 'Division of Radiation Oncology.'}, {'ForeName': 'Napatra', 'Initials': 'N', 'LastName': 'Tovanabutra', 'Affiliation': 'Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Siri', 'Initials': 'S', 'LastName': 'Chiewchanvit', 'Affiliation': 'Division of Dermatology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Patumrat', 'Initials': 'P', 'LastName': 'Sripan', 'Affiliation': 'Division of Radiation Oncology.'}, {'ForeName': 'Ausareeya', 'Initials': 'A', 'LastName': 'Chumachote', 'Affiliation': 'Division of Radiation Oncology.'}, {'ForeName': 'Wannapha', 'Initials': 'W', 'LastName': 'Nobnop', 'Affiliation': 'Division of Radiation Oncology.'}, {'ForeName': 'Damrongsak', 'Initials': 'D', 'LastName': 'Tippanya', 'Affiliation': 'Division of Radiation Oncology.'}, {'ForeName': 'Darat', 'Initials': 'D', 'LastName': 'Khamchompoo', 'Affiliation': 'Division of Radiation Oncology.'}]","Breast care (Basel, Switzerland)",['10.1159/000496062']
732,31629655,Triple strength utility of the Modified Drug Adherence Work-Up (M-DRAW) tool in a veterans affairs outpatient diabetes clinic.,"OBJECTIVE
The purpose of this study was to test the psychometric properties of the M-DRAW tool and to examine its applicability and utility at a primary clinic setting in patients with diabetes.
METHODS
A prospective, pre-post interview design study was conducted at the VA Loma Linda Health System (VALLHS) from 03/2017-03/2018. Eligibility criteria consisted of English-speaking patrons who were 18 years and older, diagnosed with Type 2 diabetes mellitus, residing in non-institutional setting, and having 1 + prescriptions for diabetes. A priming question about self-reported adherence was used to assign participants to control (Group A) or intervention (Group N). Pharmacist-led interventions were thus directed to those who recognized their medication nonadherence issue. The M-DRAW tool consisted of 13 statements about barriers to adherence on a 4-point frequency scale. A ""3 = sometimes"" or ""4 = often"" on each item indicated a barrier to adherence that was then addressed using the GUIDE strategy using motivational interviewing with the participant.
RESULTS
Of the 200 eligible individuals, 88 participants completed both baseline and follow-up assessments (Group A, n = 63; Group N, n = 25). Participants were male (98.8%), taking 7-8 medications on average, and using insulin (79.5%). The tool yielded good internal consistency (Cronbach's alpha = 0.873). Using confirmatory factor analysis, four factors were extracted with items loading as hypothesized. At baseline, group N identified three times greater number of barriers from the M-DRAW tool compared to Group A (5.1 items vs. 1.7, p < 0.05). At 3-month follow-up, a decrease in the number of barriers was observed among Group N. Both PDC and HbA1c did not result in statistically significant reduction in pre-post change.
CONCLUSIONS
The M-DRAW tool is shown to be reliable and valid. A tailored intervention reduced the number of barriers contributing to medication nonadherence and resulted in a trend of improved clinical outcomes.",2020,A tailored intervention reduced the number of barriers contributing to medication nonadherence and resulted in a trend of improved clinical outcomes.,"['Participants were male (98.8%), taking 7-8 medications on average, and using insulin (79.5', 'patients with diabetes', '200 eligible individuals', 'veterans affairs outpatient diabetes clinic', 'Eligibility criteria consisted of English-speaking patrons who were 18 years and older, diagnosed with Type 2 diabetes mellitus, residing in non-institutional setting, and having 1\xa0+\xa0prescriptions for diabetes']",['Modified Drug Adherence Work-Up (M-DRAW'],"['number of barriers contributing to medication nonadherence', 'number of barriers']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0746935', 'cui_str': 'Medication Non-Adherence'}]",88.0,0.0456353,A tailored intervention reduced the number of barriers contributing to medication nonadherence and resulted in a trend of improved clinical outcomes.,"[{'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'High Point University, School of Pharmacy, Department of Clinical Sciences, One University Parkway, High Point, NC, 27268, USA. Electronic address: slee1@highpoint.edu.'}, {'ForeName': 'Yuna H', 'Initials': 'YH', 'LastName': 'Bae-Shaaw', 'Affiliation': 'University of Southern California, School of Pharmacy, Schaeffer Center for Health Policy and Economics, 635 Downey Way, Verna & Peter Dauterive Hall (VPD), 2nd Floor, Los Angeles, CA, 90089, USA. Electronic address: hyojungb@usc.edu.'}, {'ForeName': 'Hyma', 'Initials': 'H', 'LastName': 'Gogineni', 'Affiliation': 'Western University of Health Sciences, College of Pharmacy, Department of Pharmacy Practice and Administration, 309 East Second Street., Pomona, CA, 91766, USA. Electronic address: hgogineni@westernu.edu.'}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Worley', 'Affiliation': 'The Ohio State University, College of Pharmacy, Division of Pharmacy Practice and Science, A214 Parks Hall, 500 W. 12th Avenue, Columbus, OH, 43210, USA. Electronic address: worley.18@osu.edu.'}, {'ForeName': 'Anandi V', 'Initials': 'AV', 'LastName': 'Law', 'Affiliation': 'Western University of Health Sciences, College of Pharmacy, Department of Pharmacy Practice and Administration, 309 East Second Street., Pomona, CA, 91766, USA. Electronic address: alaw@westernu.edu.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.09.063']
733,29401202,Effects of Different Plyometric Training Frequency on Measures of Athletic Performance in Prepuberal Male Soccer Players.,"This study aimed to compare the effects of one vs. two sessions of equal-weekly volume plyometric training (PT) across 8 weeks on measures of athletic performance (i.e., sprint-time, change of direction [CoD], jumping ability, and muscle strength) in prepuberal male soccer players. Thirty participants were randomly assigned either to one session PT group (1SPT [n=15]) or two sessions PT group (2SPT [n=15]). Plyometric training was integrated into their regular soccer training routine. Pre- and post-training tests for the assessment of sprint-time (e.g., 5-m, 10-m, 20-m, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], counter-movement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance were conducted. Results showed a main effect of time for 5-m sprint-time performance (F(1,56)=4.00, ES=0.53 [medium], p=0.05), T-test (F(1,56)=23.19, ES=1.28 [large], p<0.001), MICODT (F(1,56)= 5.72, ES=0.94 [large], p=0.02), SLJ (F(1,56)=16.63, ES=1.09 [large], p<0.001), CMJ (F(1,56) =15.43, ES= 1.04 [large], p<0.001), SJ (F(1,56) =20.27, ES=1.20 [large], p<0.001), RSI (F(1,56)=26.26, ES=1.36 [large], p<0.001), and kicking distance (F(1,56)=47.19, ES=1.83 [large], p<0.001). There were no training group × time interactions in all the measured outcomes. In conclusion, when an equated moderate volume of jumps is performed, higher PT frequency across 8 weeks has no extra-effects on prepuberal male soccer players' measures of athletic performance. The present findings may help optimizing PT interventions dedicated to prepuberal male soccer players.",2018,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56)=4.00, ES=0.53 [medium], p=0.05), T-test (F(1,56)=23.19, ES=1.28 [large], p<0.001), MICODT (F(1,56)= 5.72, ES=0.94 [large], p=0.02), SLJ (F(1,56)=16.63, ES=1.09 [large], p<0.001), CMJ (F(1,56) =15.43,","['prepuberal male soccer players', 'Thirty participants', 'Prepuberal Male Soccer Players']","['Plyometric training', 'Plyometric Training Frequency', 'equal-weekly volume plyometric training (PT']","['Athletic Performance', 'athletic performance', 'athletic performance (i.e., sprint-time, change of direction [CoD], jumping ability, and muscle strength', 'time for 5-m sprint-time performance', 'RSI', 'kicking distance', 'time interactions', 'sprint-time (e.g., 5-m, 10-m, 20-m, and 30-m), CoD (e.g., T-test and modified Illinois change of direction test [MICODT]), jumping ability (e.g., standing long jump [SLJ], counter-movement jump [CMJ], and squat jump [SJ]), muscle strength (reactive strength index [RSI]), and kicking distance']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0459207', 'cui_str': 'Cod'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.0328368,"Results showed a main effect of time for 5-m sprint-time performance (F(1,56)=4.00, ES=0.53 [medium], p=0.05), T-test (F(1,56)=23.19, ES=1.28 [large], p<0.001), MICODT (F(1,56)= 5.72, ES=0.94 [large], p=0.02), SLJ (F(1,56)=16.63, ES=1.09 [large], p<0.001), CMJ (F(1,56) =15.43,","[{'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Bouguezzi', 'Affiliation': ""Research Unit (UR17JS01) 'Sport Performance & Health' Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.""}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Am Neuen Palais 10, 14469 Potsdam, Germany.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': ""Research Unit (UR17JS01) 'Sport Performance & Health' Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, Universidad de Los Lagos, Osorno, Chile.'}, {'ForeName': 'Zied', 'Initials': 'Z', 'LastName': 'Jlalia', 'Affiliation': 'Faculty of Medicine of Tunis, University of Tunis El Manar, Orthopedic pediatric department, Kassab institute of orthopedic surgery, Ksar said, Tunisia.'}, {'ForeName': 'Bessem', 'Initials': 'B', 'LastName': 'Mkaouer', 'Affiliation': 'Higher Institute of Sports and Physical Education of Ksar Said, Tunis, Tunisia.'}, {'ForeName': 'Younés', 'Initials': 'Y', 'LastName': 'Hachana', 'Affiliation': ""Research Unit (UR17JS01) 'Sport Performance & Health' Higher Institute of Sport and Physical Education of Ksar Said, Tunis, Tunisia.""}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002486']
734,29422211,Outcome in early-onset fetal growth restriction is best combining computerized fetal heart rate analysis with ductus venosus Doppler: insights from the Trial of Umbilical and Fetal Flow in Europe.,"BACKGROUND
Early-onset fetal growth restriction represents a particular dilemma in clinical management balancing the risk of iatrogenic prematurity with waiting for the fetus to gain more maturity, while being exposed to the risk of intrauterine death or the sequelae of acidosis.
OBJECTIVE
The Trial of Umbilical and Fetal Flow in Europe was a European, multicenter, randomized trial aimed to determine according to which criteria delivery should be triggered in early fetal growth restriction. We present the key findings of the primary and secondary analyses.
STUDY DESIGN
Women with fetal abdominal circumference <10th percentile and umbilical pulsatility index >95th percentile between 26-32 weeks were randomized to 1 of 3 monitoring and delivery protocols. These were: fetal heart rate variability based on computerized cardiotocography; and early or late ductus venosus Doppler changes. A safety net based on fetal heart rate abnormalities or umbilical Doppler changes mandated delivery irrespective of randomized group. The primary outcome was normal neurodevelopmental outcome at 2 years.
RESULTS
Among 511 women randomized, 362/503 (72%) had associated hypertensive conditions. In all, 463/503 (92%) of fetuses survived and cerebral palsy occurred in 6/443 (1%) with known outcome. Among all women there was no difference in outcome based on randomized group; however, of survivors, significantly more fetuses randomized to the late ductus venosus group had a normal outcome (133/144; 95%) than those randomized to computerized cardiotocography alone (111/131; 85%). In 118/310 (38%) of babies delivered <32 weeks, the indication was safety-net criteria: 55/106 (52%) in late ductus venosus, 37/99 (37%) in early ductus venosus, and 26/105 (25%) in computerized cardiotocography groups. Higher middle cerebral artery impedance adjusted for gestation was associated with neonatal survival without severe morbidity (odds ratio, 1.24; 95% confidence interval, 1.02-1.52) and infant survival without neurodevelopmental impairment at 2 years (odds ratio, 1.33; 95% confidence interval, 1.03-1.72) although birthweight and gestational age were more important determinants.
CONCLUSION
Perinatal and 2-year outcome was better than expected in all randomized groups. Among survivors, 2-year neurodevelopmental outcome was best in those randomized to delivery based on late ductus venosus changes. Given a high rate of delivery based on the safety-net criteria, deciding delivery based on late ductus venosus changes and abnormal computerized fetal heart rate variability seems prudent. There is no rationale for delivery based on cerebral Doppler changes alone. Of note, most women with early-onset fetal growth restriction develop hypertension.",2018,"Higher middle cerebral artery impedance adjusted for gestation was associated with neonatal survival without severe morbidity (odds ratio, 1.24; 95% confidence interval, 1.02-1.52) and infant survival without neurodevelopmental impairment at 2 years (odds ratio, 1.33; 95% confidence interval, 1.03-1.72) although birthweight and gestational age were more important determinants.
","['Europe', '511 women randomized, 362/503 (72%) had associated hypertensive conditions', 'women with early-onset fetal growth restriction develop hypertension', 'Women with fetal abdominal circumference <10th percentile and umbilical pulsatility index', '95th percentile between 26-32 weeks']",['computerized cardiotocography'],"['normal neurodevelopmental outcome at 2 years', 'neonatal survival without severe morbidity', 'infant survival without neurodevelopmental impairment', 'fetal heart rate variability', 'cerebral palsy', '2-year neurodevelopmental outcome']","[{'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0015934', 'cui_str': 'Intrauterine Growth Restriction'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0007208', 'cui_str': 'Electronic Fetal Monitoring'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0429478', 'cui_str': 'Fetal heart rate variability (observable entity)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]",511.0,0.209218,"Higher middle cerebral artery impedance adjusted for gestation was associated with neonatal survival without severe morbidity (odds ratio, 1.24; 95% confidence interval, 1.02-1.52) and infant survival without neurodevelopmental impairment at 2 years (odds ratio, 1.33; 95% confidence interval, 1.03-1.72) although birthweight and gestational age were more important determinants.
","[{'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Frusca', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Parma, Parma, Italy.'}, {'ForeName': 'Tullia', 'Initials': 'T', 'LastName': 'Todros', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turin, Turin, Italy.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Lees', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, United Kingdom; Department of Development and Regeneration, Katholieke Universiteit Leuven, Leuven, Belgium. Electronic address: christoph.lees@nhs.net.'}, {'ForeName': 'Caterina M', 'Initials': 'CM', 'LastName': 'Bilardo', 'Affiliation': 'Department of Obstetrics, Gynecology, and VU University Medical Centre, Amsterdam and University Medical Centre Groningen, University of Groningen, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2017.12.226']
735,31597517,Improving Attitudes to Volunteering Among Older Adults: A Randomized Trial Approach.,"Promoting engagement in formal volunteering represents a potential means of facilitating healthy aging. Given reluctance to participate in volunteering has been partially attributed to negative perceptions of various aspects of this activity, this study assessed whether trialing volunteering can improve perceptions among older people. Using a parallel-group design, Australians aged 60+ years ( n = 445) were randomly assigned to one of two conditions, one in which they were encouraged to trial volunteering and one in which they were asked to continue their usual activities. Perceptions and attitudes among those in the volunteering condition became significantly more favorable over 6 months relative to those in the control condition, with this change predicted by several aspects of the volunteering experience (e.g., acquisition of skills, increased social connectedness). Providing access to roles that cater to the learning and social needs of older adults appears to be important for improving attitudes toward engaging in volunteer work.",2020,"Perceptions and attitudes among those in the volunteering condition became significantly more favorable over 6 months relative to those in the control condition, with this change predicted by several aspects of the volunteering experience (e.g., acquisition of skills, increased social connectedness).","['Older Adults', 'older people', 'older adults', 'Australians aged 60+ years ( n = 445']",[],"['acquisition of skills, increased social connectedness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",445.0,0.0170586,"Perceptions and attitudes among those in the volunteering condition became significantly more favorable over 6 months relative to those in the control condition, with this change predicted by several aspects of the volunteering experience (e.g., acquisition of skills, increased social connectedness).","[{'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Jongenelis', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Warburton', 'Affiliation': 'John Richards Centre, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'School of Psychology, Curtin University, Perth, Australia.'}]",Research on aging,['10.1177/0164027519877476']
736,29353219,Blocking mitochondrial cyclophilin D ameliorates TSH-impaired defensive barrier of artery.,"AIMS
Endothelial cells (ECs) constitute the defensive barrier of vasculature, which maintains the vascular homeostasis. Mitochondrial oxidative stress (mitoOS) in ECs significantly affects the initiation and progression of vascular diseases. The higher serum thyroid stimulating hormone (TSH) level is being recognized as a nonconventional risk factor responsible for the increased risk of cardiovascular diseases in subclinical hypothyroidism (SCH). However, effects and underlying mechanisms of elevated TSH on ECs are still ambiguous. We sought to investigate whether cyclophilin D (CypD), emerging as a crucial mediator in mitoOS, regulates effects of TSH on ECs.
METHODS AND RESULTS
SCH patients with TSH > = 10mIU/L showed a positive correlation between serum TSH and endothelin-1 levels. When TSH levels declined to normal in these subjects after levothyroxine therapy, serum endothelin-1 levels were significantly reduced. Supplemented with exogenous thyroxine to keep normal thyroid hormones, thyroid-specific TSH receptor (TSHR)-knockout mice with injection of exogenous TSH exhibited elevated serum TSH levels, significant endothelial oxidative injuries and disturbed endothelium-dependent vasodilation. However, Tshr -/- mice resisted to TSH-impaired vasotonia. We further confirmed that elevated TSH triggered excessive mitochondrial permeability transition pore (mPTP) opening and mitochondrial oxidative damages in mouse aorta, as well as in cultured ECs. Genetic or pharmacological inhibition of CypD (the key regulator for mPTP opening) attenuated TSH-induced mitochondrial oxidative damages and further rescued endothelial functions. Finally, we confirmed that elevated TSH could activate CypD by enhancing CypD acetylation via inhibiting adenosine monophosphate-activated protein kinase/sirtuin-3 signaling pathway in ECs.
CONCLUSIONS
These findings reveal that elevated TSH triggers mitochondrial perturbations in ECs and provide insights that blocking mitochondrial CypD enhances the defensive ability of ECs under TSH exposure.",2018,Genetic or pharmacological inhibition of CypD (the key regulator for mPTP opening) attenuated TSH-induced mitochondrial oxidative damages and further rescued endothelial functions.,['SCH patients with TSH > '],"['exogenous thyroxine', 'cyclophilin D']","['TSH-impaired vasotonia', 'TSH levels', 'serum endothelin-1 levels', 'Mitochondrial oxidative stress (mitoOS', 'higher serum thyroid stimulating hormone (TSH) level', 'serum TSH and endothelin-1 levels', 'serum TSH levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}]","[{'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}, {'cui': 'C0390425', 'cui_str': 'cyclophilin-40'}]","[{'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C1277938', 'cui_str': 'Serum TSH measurement'}]",,0.0551746,Genetic or pharmacological inhibition of CypD (the key regulator for mPTP opening) attenuated TSH-induced mitochondrial oxidative damages and further rescued endothelial functions.,"[{'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Deparment of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China; Shandong Key Laboratory of Endocrinology and Lipid Metabolism, Jinan, Shandong 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong 250021, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Department of Biological Sciences, The University of Texas at Dallas, Richardson, TX 75080, United States.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chai', 'Affiliation': 'Department of Cardiovascular Disease, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong 250001, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiovascular Disease, Institute of Basic Medicine, Shandong Academy of Medical Sciences, Jinan, Shandong 250001, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Deparment of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China; Shandong Key Laboratory of Endocrinology and Lipid Metabolism, Jinan, Shandong 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong 250021, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Deparment of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China; Shandong Key Laboratory of Endocrinology and Lipid Metabolism, Jinan, Shandong 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong 250021, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong 250021, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Department of Pharmacy, Shandong Provincial Hospital affiliated to Shandong University, Jinan, Shandong 250021, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Scientific Center, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Deparment of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China; Shandong Key Laboratory of Endocrinology and Lipid Metabolism, Jinan, Shandong 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong 250021, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': 'Deparment of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China; Shandong Key Laboratory of Endocrinology and Lipid Metabolism, Jinan, Shandong 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong 250021, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong 250021, China; Scientific Center, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China. Electronic address: gaoling1@medmail.com.cn.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Deparment of Endocrinology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China; Shandong Key Laboratory of Endocrinology and Lipid Metabolism, Jinan, Shandong 250021, China; Institute of Endocrinology and Metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong 250021, China. Electronic address: jjzhao@medmail.com.cn.'}]",Redox biology,['10.1016/j.redox.2018.01.004']
737,31166679,Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer.,"BACKGROUND
An earlier analysis of this phase 3 trial showed that the addition of a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor to endocrine therapy provided a greater benefit with regard to progression-free survival than endocrine therapy alone in premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Here we report the results of a protocol-specified interim analysis of the key secondary end point of overall survival.
METHODS
We randomly assigned patients to receive either ribociclib or placebo in addition to endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen). Overall survival was evaluated with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods.
RESULTS
A total of 672 patients were included in the intention-to-treat population. There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group. The addition of ribociclib to endocrine therapy resulted in significantly longer overall survival than endocrine therapy alone. The estimated overall survival at 42 months was 70.2% (95% confidence interval [CI], 63.5 to 76.0) in the ribociclib group and 46.0% (95% CI, 32.0 to 58.9) in the placebo group (hazard ratio for death, 0.71; 95% CI, 0.54 to 0.95; P = 0.00973 by log-rank test). The survival benefit seen in the subgroup of 495 patients who received an aromatase inhibitor was consistent with that in the overall intention-to-treat population (hazard ratio for death, 0.70; 95% CI, 0.50 to 0.98). The percentage of patients who received subsequent antineoplastic therapy was balanced between the groups (68.9% in the ribociclib group and 73.2% in the placebo group). The time from randomization to disease progression during receipt of second-line therapy or to death was also longer in the ribociclib group than in the placebo group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.55 to 0.87).
CONCLUSIONS
This trial showed significantly longer overall survival with a CDK4/6 inhibitor plus endocrine therapy than with endocrine therapy alone among patients with advanced hormone-receptor-positive, HER2-negative breast cancer. No new concerns regarding toxic effects emerged with longer follow-up. (Funded by Novartis; MONALEESA-7 ClinicalTrials.gov number, NCT02278120.).",2019,There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group.,"['672 patients were included in the intention-to-treat population', 'Breast Cancer', 'premenopausal or perimenopausal patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer', 'patients with advanced hormone-receptor-positive, HER2-negative breast cancer']","['CDK4/6 inhibitor plus endocrine therapy', 'placebo', 'Ribociclib plus Endocrine Therapy', 'endocrine therapy alone', 'ribociclib or placebo', 'endocrine therapy (goserelin and either a nonsteroidal aromatase inhibitor or tamoxifen']","['survival benefit seen', 'overall survival', 'Overall Survival', 'Overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",672.0,0.604589,There were 83 deaths among 335 patients (24.8%) in the ribociclib group and 109 deaths among 337 patients (32.3%) in the placebo group.,"[{'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Yen-Shen', 'Initials': 'YS', 'LastName': 'Lu', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Franke', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Chow', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Keun-Seok', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Campos-Gomez', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Villanueva-Vazquez', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Kyung-Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Arunava', 'Initials': 'A', 'LastName': 'Chakravartty', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Hughes', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Gounaris', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez-Lorenc', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Taran', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Hurvitz', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}, {'ForeName': 'Debu', 'Initials': 'D', 'LastName': 'Tripathy', 'Affiliation': ""From Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine (S.-A.I.), the Yonsei Cancer Center, Yonsei University Health System (J.S.), and the Asan Medical Center, University of Ulsan College of Medicine (K.-H.J.), Seoul, and the Center for Breast Cancer, National Cancer Center, Gyeonggi-do (K.-S.L.) - all in South Korea; National Taiwan University Hospital, Taipei, Taiwan (Y.-S.L.); Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston (A.B.); the Breast Center, Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, Munich, Germany (N.H.); the Division of Medical Senology, Istituto Europeo di Oncologia, Milan (M.C.); Hospital de Caridade de Ijuí, CACON, Ijuí, Brazil (F.F.); the Organisation for Oncology and Translational Research, Hong Kong (L.C.); Centro Oncológico Estatal, Instituto de Seguridad Social del Estado de México y Municipios, Toluca, Mexico (S.C.-G.); Institut Català d'Oncologia, Hospital de Sant Joan Despí Moisès Broggi, Barcelona (R.V.-V.); Novartis Pharmaceuticals, East Hanover, NJ (A.C., K.R.-L., T.T.); Novartis, Basel, Switzerland (G.H., I.G.); the UCLA Jonsson Comprehensive Cancer Center, Los Angeles (S.H.); and the University of Texas M.D. Anderson Cancer Center, Houston (D.T.).""}]",The New England journal of medicine,['10.1056/NEJMoa1903765']
738,31624439,Clinical Evaluation of Microneedling Therapy in the Management of Facial Scar: A Prospective Randomized Study.,"Purpose
To evaluate the therapeutic efficacy and complications of microneedling (dermaroller) therapy as a treatment modality in the treatment of facial scars resulting from acne, trauma and surgery.
Materials and Methods
Fifty patients with facial acne scar, traumatic scar, hypertrophic scars and scars with skin discoloration reporting to our institute were included in the study. Microneedling procedure was performed with the help of dermaroller. Postoperative wound was evaluated by three evaluators by comparing preoperative and postoperative clinical photographs.
Results
Seven out of the total 50 patients (14%) showed an excellent response to dermaroller treatment, while 26 patients (52%) had a good response. Fourteen patients (28%) had fair response, and 3 patients (6%) had poor response.
Conclusion
Microneedling therapy with dermaroller is one of the simplest, yet most effective skin treatments for scars, stretch marks, deep wrinkles, etc. The dermaroller is a definitive credit crunch skin rescue option. It is simple yet effective and suitable for all skin types and skin tones.",2019,"Conclusion
Microneedling therapy with dermaroller is one of the simplest, yet most effective skin treatments for scars, stretch marks, deep wrinkles, etc.","['Facial Scar', 'facial scars resulting from acne, trauma and surgery', 'Fifty patients with facial acne scar, traumatic scar, hypertrophic scars and scars with skin discoloration reporting to our institute were included in the study']","['microneedling (dermaroller) therapy', 'Microneedling Therapy']",['poor response'],"[{'cui': 'C2229249', 'cui_str': 'Facial scar'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C0036282', 'cui_str': 'Traumatic scar'}, {'cui': 'C0162810', 'cui_str': 'Scars, Hypertrophic'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0151907', 'cui_str': 'Discoloration of skin (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}]",50.0,0.019501,"Conclusion
Microneedling therapy with dermaroller is one of the simplest, yet most effective skin treatments for scars, stretch marks, deep wrinkles, etc.","[{'ForeName': 'Manjunatha Reddy', 'Initials': 'MR', 'LastName': 'Bandral', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, GDC&RI, VIMS, Cantonment, Bellary, 583104 India.'}, {'ForeName': 'Pritish H', 'Initials': 'PH', 'LastName': 'Padgavankar', 'Affiliation': ""Dr. Prit's CosmoDent & Trichology Centre, Amravati, India.""}, {'ForeName': 'Sharanbasappa R', 'Initials': 'SR', 'LastName': 'Japatti', 'Affiliation': '3Department of Oral and Maxillofacial Surgery, A.C.P.M. Dental College and Hospital, Dhule, India.'}, {'ForeName': 'Priyadarshani J', 'Initials': 'PJ', 'LastName': 'Gir', 'Affiliation': '3Department of Oral and Maxillofacial Surgery, A.C.P.M. Dental College and Hospital, Dhule, India.'}, {'ForeName': 'Chidambar Y', 'Initials': 'CY', 'LastName': 'Siddegowda', 'Affiliation': '3Department of Oral and Maxillofacial Surgery, A.C.P.M. Dental College and Hospital, Dhule, India.'}, {'ForeName': 'Rushikesh J', 'Initials': 'RJ', 'LastName': 'Gir', 'Affiliation': '5Sinhgad Dental College and Hospital, Pune, India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-018-1155-7']
739,31628019,Assessing barriers and increasing use of immunization information systems in independent community pharmacies: Study protocol for a randomized controlled trial.,"BACKGROUND
As the number of providers administering vaccines increases, including pharmacists, there is a concern of fragmented immunization records in state and regional immunization information systems (IIS). In order for IIS to have complete records, it is critical that each provider administering vaccines, including pharmacists, participate and update the IIS each time a vaccine is administered to a patient. In Alabama, provider participation in the state IIS is not mandatory; as a result, less than 25% of adults over the age of 19 have immunization data recorded. IIS participation among independent pharmacies is of particular concern as approximately 40% of Alabama pharmacies are independently owned, but only 27% of these are enrolled in the IIS.
OBJECTIVE
The objective of this report is to describe a study protocol to assess the impact of an IIS training program among community pharmacies' IIS enrollment and actual participation rates.
METHODS
The research design is a randomized controlled trial. Study participants are Alabama pharmacists who work in independently owned pharmacies that currently provide at least one type of non-seasonal vaccine and are not currently enrolled in the Alabama IIS. Multiple outcomes including awareness, knowledge, attitudes, intention, IIS enrollment, and IIS participation will be compared between intervention and control groups across three time points (baseline, one-month, and three-months). Individual and organizational factors will be measured to identify any possible associations with outcomes.
IMPLICATIONS
The expected outcome is to create an effective training program that is scalable and ready for dissemination. If successful, this training program can be replicated and used to significantly impact the completeness and accuracy of IIS across the U.S., providing the potential for IIS to be used consistently in assessing immunization status and recommending additional vaccines in the pharmacy setting, thereby improving vaccination coverage and making the provision of immunizations safe and efficient.",2020,"If successful, this training program can be replicated and used to significantly impact the completeness and accuracy of IIS across the U.S., providing the potential for IIS to be used consistently in assessing immunization status and recommending additional vaccines in the pharmacy setting, thereby improving vaccination coverage and making the provision of immunizations safe and efficient.","['independent community pharmacies', 'Study participants are Alabama pharmacists who work in independently owned pharmacies that currently provide at least one type of non-seasonal vaccine and are not currently enrolled in the Alabama IIS']",['IIS training program'],"['awareness, knowledge, attitudes, intention, IIS enrollment, and IIS participation']","[{'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0521113', 'cui_str': 'Non-seasonal (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0555944,"If successful, this training program can be replicated and used to significantly impact the completeness and accuracy of IIS across the U.S., providing the potential for IIS to be used consistently in assessing immunization status and recommending additional vaccines in the pharmacy setting, thereby improving vaccination coverage and making the provision of immunizations safe and efficient.","[{'ForeName': 'Tessa J', 'Initials': 'TJ', 'LastName': 'Hastings', 'Affiliation': 'University of South Carolina College of Pharmacy, Department of Clinical Pharmacy and Outcomes Sciences, 715 Sumter Street, Columbia, 29208, SC, USA. Electronic address: hastint@mailbox.sc.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ha', 'Affiliation': 'Stanford Health Care, 300 Pasteur Drive, Stanford, 94305, CA, USA. Electronic address: davidrossha@gmail.com.'}, {'ForeName': 'Brent I', 'Initials': 'BI', 'LastName': 'Fox', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306 Walker Building, Auburn, 36849, AL, USA. Electronic address: foxbren@auburn.edu.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306 Walker Building, Auburn, 36849, AL, USA. Electronic address: jzq0004@auburn.edu.'}, {'ForeName': 'Joni', 'Initials': 'J', 'LastName': 'Lakin', 'Affiliation': 'Auburn University College of Education, Department of Educational Foundations, Leadership, and Technology, 4072 Haley Center, Auburn, 36849, AL, USA. Electronic address: jml0035@auburn.edu.'}, {'ForeName': 'Salisa C', 'Initials': 'SC', 'LastName': 'Westrick', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 4306 Walker Building, Auburn, 36849, AL, USA. Electronic address: westrsc@auburn.edu.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.10.007']
740,31056640,Evaluation of a simple technique aiming at optimizing point-by-point isolation of the left pulmonary veins: a randomized study.,"AIMS
We sought to evaluate the efficacy and the safety of a simple technique for stabilizing the ablation catheter during anterior pulmonary vein (PV) encirclement in patients ablated for paroxysmal atrial fibrillation. This consisted of bending the ablation catheter in the left atrium, creating a loop that was cautiously advanced together with the long sheath at the ostium and then within the left superior PV. The curve was then progressively released to reach a stable contact with the anterior part of the left PVs.
METHODS AND RESULTS
Eighty consecutive patients (age 64 ± 11 years, left atrial diameter 43 ± 8 mm) undergoing 'CLOSE'-guided PV isolation were prospectively randomized into two groups depending on whether the loop technique was used or not. When using the loop technique, the encirclement of the left PVs was shorter [20 min (interquartile range, IQR 17-24) vs. 26 min (IQR 18-33), P < 0.01] with a high rate of first pass isolation [(100%) vs. (97%), P = 0.9] and adenosine proof isolation [(93%) vs. (95%), P = 0.67]. Most specifically, at the anterior part of the left PVs, there were less dislocations [0 (IQR 0-0) vs. 1 (IQR 0-4), P < 0.001], radiofrequency duration was shorter (272 ± 85 s vs. 378 ± 122 s, P < 0.001), force-time integral was higher [524 gs (IQR 427-687) vs. 398 gs (IQR 354-451), P < 0.001], average contact force was higher [20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14), P < 0.001].
CONCLUSION
This study describes a simple technique to facilitate catheter stability at the anterior part of the left PVs, resulting in more efficient left PV encirclement without compromising safety.",2019,"[20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14),","[""Eighty consecutive patients (age 64\u2009±\u200911\u2009years, left atrial diameter 43\u2009±\u20098\u2009mm) undergoing 'CLOSE'-guided PV isolation"", 'patients ablated for paroxysmal atrial fibrillation']","['simple technique for stabilizing the ablation catheter during anterior pulmonary vein (PV) encirclement', 'simple technique aiming at optimizing point-by-point isolation of the left pulmonary veins']","['impedance drop', 'average contact force', 'radiofrequency duration', 'force-time integral']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation (disorder)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0034090', 'cui_str': 'Vein of lung'}, {'cui': 'C0220862', 'cui_str': 'isolation'}]","[{'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443238', 'cui_str': 'Integral (qualifier value)'}]",80.0,0.0342701,"[20 g (IQR 13-27) vs. 11g (IQR 9-16), P < 0.001], and impedance drop was higher [12 Ω (IQR 9-19) vs. 10 Ω (IQR 7-14),","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kyriakopoulou', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Strisciuglio', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'El Haddad', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'De Pooter', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Almorad', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Van Beeumen', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Unger', 'Affiliation': 'CHU Saint Pierre, Brussels, Belgium.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Vandekerckhove', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Tavernier', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Duytschaever', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Knecht', 'Affiliation': 'Department of Cardiology, Sint-Jan Hospital Bruges, Ruddershove 10, Bruges, Belgium.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz115']
741,30024241,Social decoys: Leveraging choice architecture to alter social preferences.,"Many of society's most significant social decisions are made over sets of individuals: for example, evaluating a collection of job candidates when making a hiring decision. Rational theories of choice dictate that decision makers' preferences between any two options should remain the same irrespective of the number or quality of other options. Yet people's preferences for each option in a choice set shift in predictable ways as function of the available alternatives. These violations are well documented in consumer behavior contexts: for example, the decoy effect, in which introducing a third inferior product changes consumers' preferences for two original products. The current experiments test the efficacy of social decoys and harness insights from computational models of decision-making to examine whether choice set construction can be used to change preferences in a hiring context. Across seven experiments (N = 6312) we find that participants have systematically different preferences for the exact same candidate as a function of the other candidates in the choice set (Experiments 1a-1d, 2) and the salience of the candidate attributes under consideration (Experiments 2, 3a, 3b). Specifically, compromise and (often) asymmetric-dominance decoys increased relative preference for their yoked candidates when candidates were counterstereotypical (e.g., high warmth/low competence male candidate). More importantly, we demonstrate for the first time that we can mimic the effect of a decoy in the absence of a third candidate by manipulating participants' exposure to candidates' attributes: balanced exposure to candidates' warmth and competence information significantly reduced bias between the two candidates. (PsycINFO Database Record",2018,"Across seven experiments (N = 6312) we find that participants have systematically different preferences for the exact same candidate as a function of the other candidates in the choice set (Experiments 1a-1d, 2) and the salience of the candidate attributes under consideration (Experiments 2, 3a, 3b).",[],[],[],[],[],[],,0.0224691,"Across seven experiments (N = 6312) we find that participants have systematically different preferences for the exact same candidate as a function of the other candidates in the choice set (Experiments 1a-1d, 2) and the salience of the candidate attributes under consideration (Experiments 2, 3a, 3b).","[{'ForeName': 'Linda W', 'Initials': 'LW', 'LastName': 'Chang', 'Affiliation': 'Department of Psychology, Harvard University.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Cikara', 'Affiliation': 'Department of Psychology, Harvard University.'}]",Journal of personality and social psychology,['10.1037/pspa0000117']
742,30035581,Motivational interviewing with personalized feedback to reduce alcohol use in HIV-infected men who have sex with men: A randomized controlled trial.,"OBJECTIVE
This randomized controlled trial tested the efficacy of motivational interviewing (MI) to reduce alcohol use among heavy drinking men who have sex with men (MSM) who are engaged in HIV care but not currently receiving addictions treatment.
METHOD
One hundred eighty MSM living with HIV-recruited regardless of interest in changing drinking-were randomly assigned to MI or an assessment-only treatment as usual (TAU) control. MI comprised one in-person session followed by two brief phone calls and in-person booster sessions at 3 and 6 months. The Timeline Follow-Back Interview assessed past 30-day alcohol use and sexual behavior at 3, 6, and 12 months postbaseline, and serum samples and medical records assessed viral load, CD4 cell count, and liver function.
RESULTS
At 6 and 12 months, MI compared to TAU resulted in significantly fewer drinks per week (6 months: b = -8.72, 95% confidence interval (CI) [-12.69, -4.76]; 12 months: b = -5.98, 95% CI [-9.77, -2.19]) and lower number of heavy drinking days (6 months: incidence rate ratio = 0.55, 95% CI [0.38, 0.79]; 12 months: incidence rate ratio = 0.50, 95% CI [0.33, 0.78]). Effects on viral load, CD4 cell count, and liver function were nonsignificant. Among those reporting condomless sex with nonsteady partners at baseline, MI resulted in significantly lower rates of this behavior at 3 and 12 months compared to TAU.
CONCLUSIONS
In MSM living with HIV, MI shows substantial promise for reducing heavy drinking and for reducing condomless sex among those at risk. (PsycINFO Database Record",2018,"Among those reporting condomless sex with nonsteady partners at baseline, MI resulted in significantly lower rates of this behavior at 3 and 12 months compared to TAU.
","['heavy drinking men who have sex with men (MSM) who are engaged in HIV care but not currently receiving addictions treatment', 'HIV-infected men who have sex with men', 'One hundred eighty MSM living with HIV-recruited regardless of interest in changing drinking']","['motivational interviewing (MI', 'Motivational interviewing with personalized feedback', 'MI or an assessment-only treatment as usual (TAU) control']","['number of heavy drinking days', 'Timeline Follow-Back Interview assessed past 30-day alcohol use and sexual behavior', 'heavy drinking', 'viral load, CD4 cell count, and liver function']","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}]",180.0,0.0750936,"Among those reporting condomless sex with nonsteady partners at baseline, MI resulted in significantly lower rates of this behavior at 3 and 12 months compared to TAU.
","[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Pantalone', 'Affiliation': 'The Fenway Institute, Fenway Health Boston.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'College of Community and Public Affairs, Binghamton University.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Bove', 'Affiliation': 'Center for Statistical Sciences, Brown University School of Public Health.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Ramratnam', 'Affiliation': 'COBRE Center for Cancer Research, Lifespan Laboratories, Miriam Hospitals.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Monti', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'The Fenway Institute, Fenway Health Boston, Beth Israel Deaconess Medical Center.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000322']
743,29289531,Epileptic Seizures are Reduced by Autonomic Biofeedback Therapy Through Enhancement of Fronto-limbic Connectivity: A Controlled Trial and Neuroimaging Study.,"BACKGROUND
Thirty-percent of patients with epilepsy are drug-resistant, and might benefit from effective noninvasive therapeutic interventions. Evidence is accumulating on the efficacy of autonomic biofeedback therapy using galvanic skin response (GSR; an index of sympathetic arousal) in treating epileptic seizures. This study aimed to extend previous controlled clinical trials of autonomic biofeedback therapy with a larger homogeneous sample of patients with temporal lobe epilepsy. In addition, we used neuroimaging to characterize neural mechanisms of change in seizure frequency following the therapy.
METHODS
Forty patients with drug-resistant temporal lobe epilepsy (TLE) (age: 18 to 70years old), on stable doses of anti-epileptic medication, were recruited into a controlled and parallel-group trial from three screening centers in the UK. Patients were allocated to either an active intervention group, who received therapy with GSR biofeedback, or a control group, who received treatment as usual. Allocation to the group was informed, in part, by whether patients could travel to attend repeated therapy sessions (non-randomized). Measurement of outcomes was undertaken by an assessor blinded to the patients' group membership. Resting-state functional and structural MRI data were acquired before and after one month of therapy in the therapy group, and before and after a one-month interval in the control group. The percentage change of seizure frequency was the primary outcome measure. The analysis employed an intention-to-treat principle. The secondary outcome was the change in default mode network (DMN) and limbic network functional connectivity tested for effects of therapy. The trial was registered with the National Institute for Health Research (NIHR) portfolio (ID 15967).
FINDINGS
Data were acquired between May 2014 and October 2016. Twenty participants were assigned to each group. Two patients in the control group dropped out before the second scan, leaving 18 control participants. There was a significant difference in reduction of seizure frequency between the therapy and control groups (p<0.001: Mann Whitney U Test). The seizure frequency in the therapy group was significantly reduced (p<0.001: Wilcoxon Signed Rank Test) following GSR biofeedback, with a mean seizure reduction of 43% (SD=± 32.12, median=-37.26, 95% CI -58.02% to -27.96%). No significant seizure reduction was observed in the control group, with a mean increase in seizure frequency of 31% (SD=±88.27, median=0, 95% CI -12.83% to 74.96%). The effect size of group comparison was 1.14 (95% CI 0.44 to 1.82). 45% of patients in the therapy group showed a seizure reduction of >50%. Neuroimaging analysis revealed that post-therapy seizure reduction was linearly correlated with enhanced functional connectivity between right amygdala and both the orbitofrontal cortex (OFC) and frontal pole (FP).
INTERPRETATION
Our clinical study provides evidence for autonomic biofeedback therapy as an effective and potent behavioral intervention for patients with drug-resistant epilepsy. This approach is non-pharmacological, non-invasive and seemingly side-effect free.",2018,"The seizure frequency in the therapy group was significantly reduced (p<0.001: Wilcoxon Signed Rank Test) following GSR biofeedback, with a mean seizure reduction of 43% (SD=± 32.12, median=-37.26, 95% CI -58.02% to -27.96%).","['patients with drug-resistant epilepsy', 'Forty patients with drug-resistant temporal lobe epilepsy (TLE) (age: 18 to 70years old), on stable doses of anti-epileptic medication', 'patients with temporal lobe epilepsy', 'Twenty participants were assigned to each group']","['Autonomic Biofeedback Therapy', 'autonomic biofeedback therapy', 'active intervention group, who received therapy with GSR biofeedback']","['change in default mode network (DMN) and limbic network functional connectivity tested for effects of therapy', 'orbitofrontal cortex (OFC) and frontal pole (FP', 'seizure reduction', 'reduction of seizure frequency', 'seizure frequency', 'Resting-state functional and structural MRI data']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096063', 'cui_str': 'Refractory Epilepsy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0014556', 'cui_str': 'Epilepsy, Temporal Lobe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0149546', 'cui_str': 'Structure of frontal pole'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",20.0,0.101911,"The seizure frequency in the therapy group was significantly reduced (p<0.001: Wilcoxon Signed Rank Test) following GSR biofeedback, with a mean seizure reduction of 43% (SD=± 32.12, median=-37.26, 95% CI -58.02% to -27.96%).","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, United Kingdom. Electronic address: y.nagai@bsms.ac.uk.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Aram', 'Affiliation': 'Brighton and Sussex University Hospital, United Kingdom.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Koepp', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, Institute of Neurology University College London, United Kingdom.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Lemieux', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, Institute of Neurology University College London, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mula', 'Affiliation': 'St Georges Hospital, London, United Kingdom.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Critchley', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, United Kingdom.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sisodiya', 'Affiliation': 'Department of Clinical and Experimental Epilepsy, Institute of Neurology University College London, United Kingdom.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Cercignani', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, United Kingdom.'}]",EBioMedicine,['10.1016/j.ebiom.2017.12.012']
744,29174310,"Gefitinib versus vinorelbine plus cisplatin as adjuvant treatment for stage II-IIIA (N1-N2) EGFR-mutant NSCLC (ADJUVANT/CTONG1104): a randomised, open-label, phase 3 study.","BACKGROUND
Cisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II-IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB-IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment. We aimed to compare the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected EGFR-mutant stage II-IIIA (N1-N2) NSCLC.
METHODS
We did a randomised, open-label, phase 3 trial at 27 centres in China. We enrolled patients aged 18-75 years with completely resected (R0), stage II-IIIA (N1-N2), EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg) NSCLC. Patients were stratified by N stage and EGFR mutation status and randomised (1:1) by Pocock and Simon minimisation with a random element to either gefitinib (250 mg once daily) for 24 months or intravenous vinorelbine (25 mg/m 2 on days 1 and 8) plus intravenous cisplatin (75 mg/m 2 on day 1) every 3 weeks for four cycles. The primary endpoint was disease-free survival in the intention-to-treat population, which comprised all randomised patients; the safety population included all randomised patients who received at least one dose of study medication. Enrolment to the study is closed but survival follow-up is ongoing. The study is registered with ClinicalTrials.gov, number NCT01405079.
FINDINGS
Between Sept 19, 2011, and April 24, 2014, 483 patients were screened and 222 patients were randomised, 111 to gefitinib and 111 to vinorelbine plus cisplatin. Median follow-up was 36·5 months (IQR 23·8-44·8). Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9-32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6-22·3]; hazard ratio [HR] 0·60, 95% CI 0·42-0·87; p=0·0054). In the safety population, the most commonly reported grade 3 or worse adverse events in the gefitinib group (n=106) were raised alanine aminotransferase and asparate aminotransferase (two [2%] patients with each event vs none with vinorelbine plus cisplatin). In the vinorelbine plus cisplatin group (n=87), the most frequently reported grade 3 or worse adverse events were neutropenia (30 [34%] patients vs none with gefitinib), leucopenia (14 [16%] vs none), and vomiting (eight [9%] vs none). Serious adverse events were reported for seven (7%) patients who received gefitinib and 20 (23%) patients who received vinorelbine plus cisplatin. No interstitial lung disease was noted with gefitinib. No deaths were treatment related.
INTERPRETATION
Adjuvant gefitinib led to significantly longer disease-free survival compared with that for vinorelbine plus cisplatin in patients with completely resected stage II-IIIA (N1-N2) EGFR-mutant NSCLC. Based on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients. However, the duration of benefit with gefitinib after 24 months might be limited and overall survival data are not yet mature.
FUNDING
Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine; National Health and Family Planning Commission of People's Republic of China; Guangzhou Science and Technology Bureau; AstraZeneca China.",2018,Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9-32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6-22·3]; hazard ratio [HR],"['patients with completely resected stage II-IIIA (N1-N2) EGFR-mutant NSCLC', '27 centres in China', 'patients with EGFR-mutant stage IB-IIIA resected NSCLC', 'patients with completely resected EGFR-mutant stage II-IIIA (N1-N2) NSCLC', 'enrolled patients aged 18-75 years with completely resected (R0), stage II-IIIA (N1-N2), EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg', 'Between Sept 19, 2011, and April 24, 2014', 'patients with resected stage II-IIIA non-small-cell lung cancer (NSCLC', '483 patients were screened and 222 patients were randomised, 111 to gefitinib and 111 to']","['Gefitinib versus vinorelbine plus cisplatin', 'intravenous cisplatin', 'vinorelbine plus cisplatin', 'Cisplatin-based adjuvant chemotherapy', 'adjuvant gefitinib versus vinorelbine plus cisplatin', 'gefitinib', 'intravenous vinorelbine']","['vomiting', 'longer disease-free survival', 'raised alanine aminotransferase and asparate aminotransferase', 'disease-free survival', 'adverse events', 'neutropenia', 'superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib', 'leucopenia', 'Median disease-free survival', 'Serious adverse events', 'interstitial lung disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0457152', 'cui_str': 'Stage Ib'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0442818', 'cui_str': 'Raised (qualifier value)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}]",483.0,0.359304,Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9-32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6-22·3]; hazard ratio [HR],"[{'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': 'Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Song-Tao', 'Initials': 'ST', 'LastName': 'Xu', 'Affiliation': 'Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Yong-Yu', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Provincial Tumor Hospital, Changchun, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""The People's Hospital of Peking University, Beijing, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': ""Tangdu Hospital, Xi'an, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Fujian Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi-Dong', 'Initials': 'ZD', 'LastName': 'Liu', 'Affiliation': 'Beijing Chest Hospital, Beijing, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Shi-Dong', 'Initials': 'SD', 'LastName': 'Xu', 'Affiliation': 'Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lun-Xu', 'Initials': 'LX', 'LastName': 'Liu', 'Affiliation': 'West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Bu-Hai', 'Initials': 'BH', 'LastName': 'Wang', 'Affiliation': ""The Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Ma', 'Affiliation': 'The First Affiliated Hospital of Suzhou University, Suzhou, China.'}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': 'Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': 'Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Guangdong Lung Cancer Institute, Guangdong General Hospital, and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30729-5']
745,29108797,"Lopinavir plus nucleoside reverse-transcriptase inhibitors, lopinavir plus raltegravir, or lopinavir monotherapy for second-line treatment of HIV (EARNEST): 144-week follow-up results from a randomised controlled trial.","BACKGROUND
Millions of HIV-infected people worldwide receive antiretroviral therapy (ART) in programmes using WHO-recommended standardised regimens. Recent WHO guidelines recommend a boosted protease inhibitor plus raltegravir as an alternative second-line combination. We assessed whether this treatment option offers any advantage over the standard protease inhibitor plus two nucleoside reverse-transcriptase inhibitors (NRTIs) second-line combination after 144 weeks of follow-up in typical programme settings.
METHODS
We analysed the 144-week outcomes at the completion of the EARNEST trial, a randomised controlled trial done in HIV-infected adults or adolescents in 14 sites in five sub-Saharan African countries (Uganda, Zimbabwe, Malawi, Kenya, Zambia). Participants were those who were no longer responding to non-NRTI-based first-line ART, as assessed with WHO criteria, confirmed by viral-load testing. Participants were randomly assigned to receive a ritonavir-boosted protease inhibitor (lopinavir 400 mg with ritonavir 100 mg, twice per day) plus two or three clinician-selected NRTIs (protease inhibitor plus NRTI group), protease inhibitor plus raltegravir (400 mg twice per day; protease inhibitor plus raltegravir group), or protease inhibitor monotherapy (plus raltegravir induction for first 12 weeks, re-intensified to combination therapy after week 96; protease inhibitor monotherapy group). Randomisation was by computer-generated randomisation sequence, with variable block size. The primary outcome was viral load of less than 400 copies per mL at week 144, for which we assessed non-inferiority with a one-sided α of 0·025, and superiority with a two-sided α of 0·025. The EARNEST trial is registered with ISRCTN, number 37737787.
FINDINGS
Between April 12, 2010, and April 29, 2011, 1837 patients were screened for eligibility, of whom 1277 patients were randomly assigned to an intervention group. In the primary (complete-case) analysis at 144 weeks, 317 (86%) of 367 in the protease inhibitor plus NRTI group had viral loads of less than 400 copies per mL compared with 312 (81%) of 383 in the protease inhibitor plus raltegravir group (p=0·07; lower 95% confidence limit for difference 10·2% vs specified non-inferiority margin 10%). In the protease inhibitor monotherapy group, 292 (78%) of 375 had viral loads of less than 400 copies per mL; p=0·003 versus the protease inhibitor plus NRTI group at 144 weeks. There was no difference between groups in serious adverse events, grade 3 or 4 adverse events (total or ART-related), or events that resulted in treatment modification.
INTERPRETATION
Protease inhibitor plus raltegravir offered no advantage over protease inhibitor plus NRTI in virological efficacy or safety. In the primary analysis, protease inhibitor plus raltegravir did not meet non-inferiority criteria. A regimen of protease inhibitor with NRTIs remains the best standardised second-line regimen for use in programmes in resource-limited settings.
FUNDING
European and Developing Countries Clinical Trials Partnership (EDCTP), UK Medical Research Council, Instituto de Salud Carlos III, Irish Aid, Swedish International Development Cooperation Agency, Instituto Superiore di Sanita, Merck, ViiV Healthcare, WHO.",2018,"There was no difference between groups in serious adverse events, grade 3 or 4 adverse events (total or ART-related), or events that resulted in treatment modification.
","['Between April 12, 2010, and April 29, 2011, 1837 patients were screened for eligibility, of whom 1277 patients', 'Participants were those who were no longer responding to non-NRTI-based first-line ART, as assessed with WHO criteria, confirmed by viral-load testing', 'HIV-infected adults or adolescents in 14 sites in five sub-Saharan African countries (Uganda, Zimbabwe, Malawi, Kenya, Zambia']","['standard protease inhibitor plus two nucleoside reverse-transcriptase inhibitors (NRTIs) second-line combination', 'protease inhibitor with NRTIs', 'antiretroviral therapy (ART', 'Lopinavir plus nucleoside reverse-transcriptase inhibitors, lopinavir plus raltegravir, or lopinavir monotherapy', 'ritonavir-boosted protease inhibitor (lopinavir 400 mg with ritonavir 100 mg, twice per day) plus two or three clinician-selected NRTIs (protease inhibitor plus NRTI group), protease inhibitor plus raltegravir (400 mg twice per day; protease inhibitor plus raltegravir group), or protease inhibitor monotherapy (plus raltegravir induction for first 12 weeks, re-intensified to combination therapy']","['viral load of less', 'serious adverse events, grade 3 or 4 adverse events (total or ART-related), or events that resulted in treatment modification', 'viral loads']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0454695', 'cui_str': 'African country (geographic location)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0028621', 'cui_str': 'Nucleosides'}, {'cui': 'C4521921', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1597570', 'cui_str': 'Ritonavir 100 MG [Norvir]'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1299575', 'cui_str': 'Treatment modification'}]",1837.0,0.311924,"There was no difference between groups in serious adverse events, grade 3 or 4 adverse events (total or ART-related), or events that resulted in treatment modification.
","[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Cissy', 'Initials': 'C', 'LastName': 'Kityo', 'Affiliation': 'Joint Clinical Research Centre (JCRC) Kampala, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hoppe', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kambugu', 'Affiliation': 'Infectious Diseases Institute, Kampala, Uganda.'}, {'ForeName': 'Joep J', 'Initials': 'JJ', 'LastName': 'van Oosterhout', 'Affiliation': 'Department of Medicine, University of Malawi College of Medicine, Blantyre, Malawi; Dignitas International, Zomba, Malawi.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Lugemwa', 'Affiliation': 'JCRC Mbarara, Mbarara, Uganda.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Siika', 'Affiliation': 'Moi University School of Medicine, Eldoret, Kenya.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Mwebaze', 'Affiliation': 'St Francis of Nsambya Hospital, Kampala, Uganda.'}, {'ForeName': 'Aggrey', 'Initials': 'A', 'LastName': 'Mweemba', 'Affiliation': 'University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Abongomera', 'Affiliation': 'Joint Clinical Research Centre (JCRC) Kampala, Kampala, Uganda.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Thomason', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Easterbrook', 'Affiliation': 'Infectious Diseases Institute, Kampala, Uganda.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mugyenyi', 'Affiliation': 'Joint Clinical Research Centre (JCRC) Kampala, Kampala, Uganda.'}, {'ForeName': 'A Sarah', 'Initials': 'AS', 'LastName': 'Walker', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Paton', 'Affiliation': 'MRC Clinical Trials Unit at University College London, London, UK; Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore. Electronic address: nick_paton@nuhs.edu.sg.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(17)30630-8']
746,31603191,Personalized antiplatelet therapy guided by a novel detection of platelet aggregation function in stable coronary artery disease patients undergoing percutaneous coronary intervention: a randomized controlled clinical trial.,"AIMS
A number of studies have attempted to demonstrate the benefits associated with personalized antiplatelet therapy guided by platelet function testing, which has led to disappointing findings. In this study, we used a new platelet function test to guide antiplatelet therapy in stable coronary artery disease (CAD) patients after percutaneous coronary intervention (PCI).
METHODS AND RESULTS
In the present randomized controlled trial, a total of 2237 patients with stable CAD undergoing PCI were randomly chosen to be administered personalized antiplatelet therapy (personalized group; n = 1123) or standard antiplatelet treatment (standard group; n = 1114). The patients in the standard therapy group, without detecting the platelet aggregation rate, were administered a 75 mg/day clopidogrel maintenance dosage plus 100 mg/day of aspirin for at least 6 months after the procedure. For the patients in the personalized therapy group, the antiplatelet strategy was performed according to the maximum aggregation rate (MAR), determined using a novel platelet analyser, PL-12. If MAR > 55%, 90 mg ticagrelor was administered twice daily plus 100 mg/day of aspirin after PCI. If MAR ≤55%, 75 mg/day clopidogrel plus 100 mg/day of aspirin was administered after PCI. The primary endpoint was net clinical adverse events, which were a composite of cardiac death, myocardial infarction, stroke, stent thrombosis, urgent revascularization, and bleeding [Bleeding Academic Research Consortium (BARC) definitions, Type 2, 3, or 5], in the 180-day period after randomization. The primary endpoint was reached in 58 patients in the personalized group, compared with 85 patients in the standard group [5.1% vs. 7.5%, hazard ratio (HR) 0.678, 95% confidence interval (CI) 0.486-0.947, P = 0.023], on intention-to-treat analysis. We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR 0.510, 95% CI 0.284-0.915, P = 0.020). We did not find a significant difference in major bleeding events at either the 30-day (0.5% vs. 0.3%, P = 0.322) or the 180-day follow-up (2.1% vs. 1.6%, P = 0.364) between the two groups.
CONCLUSION
The present study suggests that personalized antiplatelet therapy according to MAR can significantly improve the net clinical benefit 180 days after PCI.",2020,"We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR: 0.510, 95% CI: 0.284-0.915, P = 0.020).","['stable coronary artery disease patients undergoing PCI', '2237 patients with stable coronary artery disease (CAD) undergoing PCI', 'stable CAD patients after PCI']","['ticagrelor', 'clopidogrel maintenance dosage plus 100\u2009mg/day of aspirin', 'personalized antiplatelet therapy (personalized group; n\u2009=\u20091123) or standard antiplatelet treatment', 'aspirin']","['net clinical adverse events, which were a composite of cardiac death, myocardial infarction (MI), stroke, stent thrombosis, urgent revascularization, and bleeding (Bleeding Academic Research Consortium (BARC) definitions, type 2, 3, or 5', 'net clinical adverse events (including ischaemic and bleeding events', 'maximum aggregation rate (MAR', 'major bleeding events', 'platelet aggregation rate']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332621', 'cui_str': 'Aggregation (finding)'}, {'cui': 'C0430991', 'cui_str': 'Mixed antiglobulin test for sperm (procedure)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}]",2237.0,0.0964211,"We also found that the net clinical adverse events (including ischaemic and bleeding events) were significantly reduced in the personalized group at 30 days after PCI compared to the standard group (1.5% vs. 3.0%, HR: 0.510, 95% CI: 0.284-0.915, P = 0.020).","[{'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xian-Geng', 'Initials': 'XG', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Cadre Ward, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi-Ning', 'Initials': 'YN', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Yi-Tong', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, No. 137, Liyushan Road, Urumqi 830054, P.R. China.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvz059']
747,31628677,Secukinumab for patients failing previous tumour necrosis factor-α inhibitor therapy: results of a randomized open-label study (SIGNATURE).,"BACKGROUND
Efficacy data on therapies for patients with psoriasis who have failed tumour necrosis factor (TNF)-α inhibitor therapy is limited.
OBJECTIVES
To determine the effectiveness and tolerability of secukinumab, an interleukin (IL)-17A inhibitor, in patients with moderate/severe chronic plaque psoriasis with documented efficacy failure of TNF-α inhibitor therapy (SIGNATURE study).
METHODS
This was a randomized, open-label, noncomparator study in 53 dermatology centres in the U.K. and Republic of Ireland. Patients were randomized 1 : 1 to receive secukinumab 300 mg or 150 mg subcutaneously every week for 4 weeks, then 4-weekly thereafter. Patients were stratified by their prior efficacy failure with TNF-α inhibitors. Only patients who started and stayed on the same dose at each time point were included for efficacy assessments.
RESULTS
In total, 233 patients were analysed. The primary end point was met, with a statistically significant improvement in response rates [75% reduction in Psoriasis Area and Severity Index (PASI 75)] from baseline to week 16 in both secukinumab 300 mg and 150 mg dose groups [77 of 118 patients (65·3%) and 51 of 115 patients (44·3%), respectively; P < 0·0001]. After 72 weeks, in patients starting and remaining on 300 mg, 77% (54 of 70) achieved PASI 75. Improvements in Dermatology Life Quality Index from baseline to week 16 occurred and were maintained up to 72 weeks. The safety profile was generally consistent with previous secukinumab studies, although a higher incidence of some adverse events (e.g. candida infections) was observed.
CONCLUSIONS
This study provides evidence of efficacy and safety of secukinumab for treatment of patients with psoriasis who failed prior TNF-α inhibitor therapy. This study represents a 'real-world' population, providing reassurance that secukinumab is a treatment option in this difficult-to-treat population. What's already known about this topic? Conventional systemic nonbiological and tumour necrosis factor (TNF)-α inhibitor therapies for plaque psoriasis have not fully met patients' needs. There is a lack of data to support the treatment pathways for patients with psoriasis who have inadequate responses to TNF-α inhibitor therapy. Secukinumab, a recombinant high-affinity fully human monoclonal anti-human interleukin-17A antibody of the IgG1/κ-class, has shown excellent safety and efficacy in the treatment of moderate-to-severe psoriasis. What does this study add? This is the first study evaluating treatment with biologics after prior efficacy failure of TNF-α inhibitor therapy as defined by the U.K. National Institute for Health and Care Excellence criteria. Secukinumab is an effective treatment in this difficult-to-treat patient population. This study provides important practical information for clinicians managing psoriasis. Adverse events were consistent with the phase III programme for secukinumab, although some adverse events, e.g. candida, were increased.",2020,Improvements in Dermatology Life Quality Index (DLQI) from baseline to Week 16 occurred and maintained up to 72 weeks.,"['psoriasis patients who failed prior TNFα-inhibitor therapy', 'psoriasis patients who have failed tumour necrosis factor (TNF)α-inhibitor therapy is limited', 'patients failing previous TNFα-inhibitor therapy', '53 dermatology centres in UK and Republic of Ireland', '233 patients were analysed', 'patients with moderate/severe chronic plaque psoriasis with documented efficacy failure to TNFα-inhibitor therapy (SIGNATURE Study']","['Secukinumab', 'secukinumab, an IL-17A inhibitor', 'secukinumab']","['Dermatology Life Quality Index (DLQI', 'efficacy and safety', 'response rates', 'Psoriasis Area and Severity Index [PASI75']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",233.0,0.0458599,Improvements in Dermatology Life Quality Index (DLQI) from baseline to Week 16 occurred and maintained up to 72 weeks.,"[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Centre for Dermatology Research, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}, {'ForeName': 'J N W B', 'Initials': 'JNWB', 'LastName': 'Barker', 'Affiliation': ""St John's Institute of Dermatology, King's College London, London, U.K.""}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Finlay', 'Affiliation': 'Division of Infection and Immunity, Cardiff University, Cardiff, U.K.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Burden', 'Affiliation': 'Centre for Dermatology Research, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kirby', 'Affiliation': ""St Vincent's University Hospital and the Charles Institute, University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Armendariz', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hatchard', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khare', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dermatology Research, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}]",The British journal of dermatology,['10.1111/bjd.18623']
748,29174695,Use of oral cholera vaccine as a vaccine probe to define the geographical dimensions of person-to-person transmission of cholera.,"BACKGROUND
Cholera is known to be transmitted from person to person, and inactivated oral cholera vaccines (OCVs) have been shown to confer herd protection via interruption of this transmission. However, the geographic dimensions of chains of person-to-person transmission of cholera are uncertain. The ability of OCVs to confer herd protection was used to define these dimensions in two cholera-endemic settings, one in rural Bangladesh and the other in urban India.
METHODS
Two large randomized, placebo-controlled trials of inactivated OCVs, one in rural Matlab, Bangladesh and the other in urban Kolkata, India, were reanalyzed. Vaccine herd protection was evaluated by relating the risk of cholera in placebo recipients to vaccine coverage of surrounding residents residing within concentric rings. In Matlab, concentric rings in 100-m increments up to 700m were evaluated; in Kolkata, 50-m increments up to 350m were evaluated.
RESULTS
One hundred and eight cholera cases among 24667 placebo recipients were detected during 1year of post-vaccination follow-up at Matlab; 128 cholera cases among 34968 placebo recipients were detected during 3 years of follow-up in Kolkata. Consistent inverse relationships were observed between vaccine coverage of the ring and the risk of cholera in the central placebo recipient for rings with radii up to 500m in Matlab and up to 150m in Kolkata.
CONCLUSIONS
These results suggest that the dimensions of chains of person-to-person transmission in endemic settings can be quite large and may differ substantially from setting to setting. Using OCVs as 'probes' to define these dimensions can inform geographical targeting strategies for the deployment of these vaccines in endemic settings.",2018,One hundred and eight cholera cases among 24667 placebo recipients were detected during 1year of post-vaccination follow-up at Matlab; 128 cholera cases among 34968 placebo recipients were detected during 3 years of follow-up in Kolkata.,"['rural Matlab, Bangladesh and the other in urban Kolkata, India, were reanalyzed', 'person-to-person transmission of cholera']","['inactivated OCVs', 'oral cholera vaccine', 'placebo']",[],"[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1444005', 'cui_str': 'Person to person transmission'}, {'cui': 'C0008354', 'cui_str': 'Vibrio cholerae Infection'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.153794,One hundred and eight cholera cases among 24667 placebo recipients were detected during 1year of post-vaccination follow-up at Matlab; 128 cholera cases among 34968 placebo recipients were detected during 3 years of follow-up in Kolkata.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kanungo', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Sur', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Byomkesh', 'Initials': 'B', 'LastName': 'Manna', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Digilio', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Marks', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sujit K', 'Initials': 'SK', 'LastName': 'Bhattacharya', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, India.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clemens', 'Affiliation': 'icddr,b, Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, USA; Korea University School of Medicine, Seoul, Republic of Korea. Electronic address: jclemens@icddrb.org.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2017.11.020']
749,31608424,"Comparing the effects of anticipatory postural adjustments focused training and balance training on postural preparation, balance confidence and quality of life in elderly with history of a fall.","BACKGROUND
Impairment of postural adjustments in elderly is associated with decreased functional mobility, balance confidence and quality of life.
AIMS
We studied the effects of anticipatory postural adjustments focused training on postural preparation, balance confidence and quality of life of the elderly.
METHODS
It was a single-blind randomized controlled trial. The sample included 60 males with history of falling (at least once in the past 6 months). They were matched and randomly assigned into three groups: perturbation, balance, and no training. The electrical activity of the muscles was measured by electromyography. The Activities-specific Balance Confidence (ABC) scale and the SF-36 questionnaire were used to assess balance confidence and quality of life, respectively. Repeated-measures ANOVA was used for data analysis (significant level 0.05).
RESULTS
The type of training had significant interaction effect on muscle latency (F (2, 46) ≥ 71.06, P ≤ 0.001, η 2 ≥ 0.75). Compared to the other two groups, perturbation training group showed significantly more improvement in ABC scale (F (2, 46) = 14.94, P ≤ 0.000, η 2 ≥ 0.39). It also significantly showed more improvement than no training group in all areas of SF-36 questionnaire, except for mental health (F (2, 46) ≥ 6.56, P ≤ 0.03, η 2 ≥ 0.22).
CONCLUSIONS
Our findings support the use of perturbation training, as it reduced the probability of falling (by decreasing muscle latency and increasing posture preparation), improved the balance confidence for daily activities, and improved the quality of life.",2020,"It also significantly showed more improvement than no training group in all areas of SF-36 questionnaire, except for mental health (F (2, 46) ≥ ","['elderly with history of a fall', '60 males with history of falling (at least once in the past 6\xa0months']","['anticipatory postural adjustments focused training', 'anticipatory postural adjustments focused training and balance training']","['Activities-specific Balance Confidence (ABC) scale and the SF-36 questionnaire', 'balance confidence and quality of life', 'quality of life', 'electrical activity of the muscles', 'functional mobility, balance confidence and quality of life', 'balance confidence for daily activities', 'SF-36 questionnaire, except for mental health (F (2, 46) \u2009≥', 'postural preparation, balance confidence and quality of life of the elderly', 'postural preparation, balance confidence and quality of life', 'ABC scale', 'muscle latency']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034380'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0222045'}]",60.0,0.0254731,"It also significantly showed more improvement than no training group in all areas of SF-36 questionnaire, except for mental health (F (2, 46) ≥ ","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Arghavani', 'Affiliation': 'Corrective Exercise and Sport Injuries, Faculty of Exercise Sciences, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Zolaktaf', 'Affiliation': 'Corrective Exercise and Sport Injuries, Faculty of Exercise Sciences, University of Isfahan, Isfahan, Iran. v.zolaktaf@spr.ui.ac.ir.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Lenjannejadian', 'Affiliation': 'Sport Biomechanics, Faculty of Exercise Sciences, University of Isfahan, Isfahan, Iran.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01358-5']
750,29030111,"Double-blind, proof-of-concept (POC) trial of Low-Field Magnetic Stimulation (LFMS) augmentation of antidepressant therapy in treatment-resistant depression (TRD).","BACKGROUND
Low-Field Magnetic Stimulation (LFMS) is a novel, non-invasive, sub-threshold neuromodulation technique, shown in preliminary studies to have immediate mood elevating effects in both unipolar and bipolar depressed patients.
OBJECTIVE
We aimed to assess the antidepressant augmentation effects at 48 h of LFMS administered on two consecutive days compared to sham treatment in treatment resistant depression (TRD) subjects, using the Sequential Parallel Comparison Design (SPCD).
METHODS
Eighty-four eligible subjects with TRD were randomly assigned to double-blind treatment with LFMS 20 min/day for four days, sham treatment 20 min/day for four days, or sham treatment 20 min/day for 2 days followed by LFMS treatment 20 min/day for two days, using the pre-randomization version of the SPCD (randomization 1:1:1). The SPCD analyses used a repeated measures linear modeling approach with maximum likelihood estimation to use all available data, and using a 60-40 weighting of Stage 1 vs. 2 responses, with the primary outcome being measured after 2 and 4 days.
RESULTS
Both primary and secondary outcome measures consistently showed no differences between LFMS-treated patients and those treated with sham, with the exception of a slight, non-significantly greater improvement than sham in the visual analogue scale (VAS) sad mood on LFMS-treated patients. LFMS treatment was relatively well tolerated.
CONCLUSIONS
We did not observe a significantly greater, rapid efficacy of LFMS compared to sham therapy. Future studies need to examine the possible therapeutic effects of more intensive forms of LFMS, as other forms of neurostimulation typically require longer duration of exposure.",2018,"Both primary and secondary outcome measures consistently showed no differences between LFMS-treated patients and those treated with sham, with the exception of a slight, non-significantly greater improvement than sham in the visual analogue scale (VAS) sad mood on LFMS-treated patients.",['Eighty-four eligible subjects with TRD'],"['Low-Field Magnetic Stimulation (LFMS', 'Low-Field Magnetic Stimulation (LFMS) augmentation of antidepressant therapy', 'LFMS']","['antidepressant augmentation effects', 'visual analogue scale (VAS) sad mood', 'tolerated']","[{'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1096649', 'cui_str': 'Antidepressant therapy'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",84.0,0.25107,"Both primary and secondary outcome measures consistently showed no differences between LFMS-treated patients and those treated with sham, with the exception of a slight, non-significantly greater improvement than sham in the visual analogue scale (VAS) sad mood on LFMS-treated patients.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, United States. Electronic address: mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, United States.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Shelton', 'Affiliation': 'University of Alabama at Birmingham, United States.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, United States.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Massachusetts General Hospital, United States.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rapaport', 'Affiliation': 'Emory University, United States.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Emory University, United States.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, United States.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, United States.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, United States.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Hermes', 'Affiliation': 'Yale University, United States.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, United States.'}]",Brain stimulation,['10.1016/j.brs.2017.09.010']
751,29255671,Molecular and functional PET-fMRI measures of placebo analgesia in episodic migraine: Preliminary findings.,"Pain interventions with no active ingredient, placebo, are sometimes effective in treating chronic pain conditions. Prior studies on the neurobiological underpinnings of placebo analgesia indicate endogenous opioid release and changes in brain responses and functional connectivity during pain anticipation and pain experience in healthy subjects. Here, we investigated placebo analgesia in healthy subjects and in interictal migraine patients (n = 9) and matched healthy controls (n = 9) using 11 C-diprenoprhine Positron Emission Tomography (PET) and simultaneous functional Magnetic Resonance Imaging (fMRI). Intravenous saline injections (the placebo) led to lower pain ratings, but we did not find evidence for an altered placebo response in interictal migraine subjects as compared to healthy subjects.",2018,"Intravenous saline injections (the placebo) led to lower pain ratings, but we did not find evidence for an altered placebo response in interictal migraine subjects as compared to healthy subjects.","['healthy subjects', 'healthy subjects and in interictal migraine patients (n\xa0=\xa09) and matched healthy controls (n\xa0=\xa09) using 11 C', 'episodic migraine']","['Intravenous saline injections (the placebo', 'diprenoprhine Positron Emission Tomography (PET) and simultaneous functional Magnetic Resonance Imaging (fMRI', 'placebo analgesia', 'placebo']",['pain ratings'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0302944', 'cui_str': '11C radioisotope'}, {'cui': 'C1455761', 'cui_str': 'Episodic (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.378843,"Intravenous saline injections (the placebo) led to lower pain ratings, but we did not find evidence for an altered placebo response in interictal migraine subjects as compared to healthy subjects.","[{'ForeName': 'Clas', 'Initials': 'C', 'LastName': 'Linnman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital, Harvard Medical School, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, USA. Electronic address: clas.linnman@childrens.harvard.edu.""}, {'ForeName': 'Ciprian', 'Initials': 'C', 'LastName': 'Catana', 'Affiliation': 'Athinoula A Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Mike P', 'Initials': 'MP', 'LastName': 'Petkov', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital, Harvard Medical School, USA; Center for Pain and the Brain, Boston Children's Hospital and Massachusetts General Hospital (MGH), Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daniel Burje', 'Initials': 'DB', 'LastName': 'Chonde', 'Affiliation': 'Athinoula A Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Becerra', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital, Harvard Medical School, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, USA; Athinoula A Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.; Center for Pain and the Brain, Boston Children's Hospital and Massachusetts General Hospital (MGH), Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hooker', 'Affiliation': 'Athinoula A Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Borsook', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Boston Children's Hospital, Harvard Medical School, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, USA; Athinoula A Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA.; Center for Pain and the Brain, Boston Children's Hospital and Massachusetts General Hospital (MGH), Harvard Medical School, Boston, MA, USA.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2017.11.011']
752,29158011,"Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial.","BACKGROUND
In animal models of breast cancer, resistance to continuous use of letrozole can be reversed by withdrawal and reintroduction of letrozole. We therefore hypothesised that extended intermittent use of adjuvant letrozole would improve breast cancer outcome compared with continuous use of letrozole in postmenopausal women.
METHODS
We did the multicentre, open-label, randomised, parallel, phase 3 SOLE trial in 240 centres (academic, primary, secondary, and tertiary care centres) in 22 countries. We enrolled postmenopausal women of any age with hormone receptor-positive, lymph node-positive, and operable breast cancer for which they had undergone local treatment (surgery with or without radiotherapy) and had completed 4-6 years of adjuvant endocrine therapy. They had to be clinically free of breast cancer at enrolment and without evidence of recurrent disease at any time before randomisation. We randomly assigned women (1:1) to treatment groups of either continuous use of letrozole (2·5 mg/day orally for 5 years) or intermittent use of letrozole (2·5 mg/day orally for 9 months followed by a 3-month break in years 1-4 and then 2·5 mg/day during all 12 months of year 5). Randomisation was done by principal investigators or designee at respective centres through the internet-based system of the International Breast Cancer Study Group, was stratified by type of previous endocrine therapy (aromatase inhibitors only vs selective oestrogen receptor modulators only vs both therapies), and used permuted block sizes of four and institutional balancing. No one was masked to treatment assignment. The primary endpoint was disease-free survival, analysed by the intention-to-treat principle using a stratified log-rank test. All patients in the intention-to-treat population who initiated protocol treatment during their period of trial participation were included in the safety analyses. This study is registered with ClinicalTrials.gov, number NCT00553410, and EudraCT, number 2007-001370-88; and long-term follow-up of patients is ongoing.
FINDINGS
Between Dec 5, 2007, and Oct 8, 2012, 4884 women were enrolled and randomised after exclusion of patients at a non-adherent centre, found to have inadequate documentation of informed consent, immediately withdrew consent, or randomly assigned to intervention groups in error. 4851 women comprised the intention-to-treat population that compared extended intermittent letrozole use (n=2425) with continuous letrozole use (n=2426). After a median follow-up of 60 months (IQR 53-72), disease-free survival was 85·8% (95% CI 84·2-87·2) in the intermittent letrozole group compared with 87·5% (86·0-88·8) in the continuous letrozole group (hazard ratio 1·08, 95% CI 0·93-1·26; p=0·31). Adverse events were reported as expected and were similar between the two groups. The most common grade 3-5 adverse events were hypertension (584 [24%] of 2417 in the intermittent letrozole group vs 517 [21%] of 2411 in the continuous letrozole group) and arthralgia (136 [6%] vs 151 [6%]). 54 patients (24 [1%] in the intermittent letrozole group and 30 [1%] in the continuous letrozole group) had grade 3-5 CNS cerebrovascular ischaemia, 16 (nine [<1%] vs seven [<1%]) had grade 3-5 CNS haemorrhage, and 40 (19 [1%] vs 21 [1%]) had grade 3-5 cardiac ischaemia. In total, 23 (<1%) of 4851 patients died while on trial treatment (13 [<1%] of 2417 patients in the intermittent letrozole group vs ten [<1%] of 2411 in the continuous letrozole group).
INTERPRETATION
In postmenopausal women with hormone receptor-positive breast cancer, extended use of intermittent letrozole did not improve disease-free survival compared with continuous use of letrozole. An alternative schedule of extended adjuvant endocrine therapy with letrozole, including intermittent administration, might be feasible and the results of the SOLE trial support the safety of temporary treatment breaks in selected patients who might require them.
FUNDING
Novartis and the International Breast Cancer Study Group.",2018,"After a median follow-up of 60 months (IQR 53-72), disease-free survival was 85·8% (95% CI 84·2-87·2) in the intermittent letrozole group compared with 87·5% (86·0-88·8) in the continuous letrozole group (hazard ratio 1·08, 95% CI 0·93-1·26; p=0·31).","['postmenopausal women', 'enrolled postmenopausal women of any age with hormone receptor-positive, lymph node-positive, and operable breast cancer for which they had undergone local treatment (surgery with or without radiotherapy) and had completed 4-6 years of adjuvant endocrine therapy', 'All patients in the intention-to-treat population who initiated protocol treatment during their period of trial participation', 'postmenopausal women with breast cancer (SOLE', 'postmenopausal women with hormone receptor-positive breast cancer', '4884 women', '4851 women comprised the intention-to-treat population that compared extended intermittent letrozole use (n=2425) with', 'selected patients who might require them', '240 centres (academic, primary, secondary, and tertiary care centres) in 22 countries']","['endocrine therapy (aromatase inhibitors only vs selective oestrogen receptor modulators', 'Extended adjuvant intermittent letrozole', 'continuous letrozole', 'letrozole (2·5 mg/day orally for 5 years) or intermittent use of letrozole', 'letrozole']","['Adverse events', 'breast cancer outcome', 'disease-free survival', 'arthralgia', 'grade 3-5 CNS cerebrovascular ischaemia']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",4884.0,0.196376,"After a median follow-up of 60 months (IQR 53-72), disease-free survival was 85·8% (95% CI 84·2-87·2) in the intermittent letrozole group compared with 87·5% (86·0-88·8) in the continuous letrozole group (hazard ratio 1·08, 95% CI 0·93-1·26; p=0·31).","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'International Breast Cancer Study Group, Milan, Italy; Division of Medical Senology, Milan, Italy. Electronic address: marco.colleoni@ieo.it.'}, {'ForeName': 'Weixiu', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'International Breast Cancer Study Group and Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'Chirgwin', 'Affiliation': 'International Breast Cancer Study Group, Australia and New Zealand Breast Cancer Trials Group, and Box Hill and Maroondah Hospitals, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Aebi', 'Affiliation': 'International Breast Cancer Study Group and Lucerne Canton Hospital, Lucerne, Switzerland.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'International Breast Cancer Study Group, Centre Hospitalier Universitaire de Liège, Liège University, Liège, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'International Breast Cancer Study Group and Multidisciplinary Breast Center, University Hospitals, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Hitre', 'Affiliation': 'International Breast Cancer Study Group and National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'Marie-Pascale', 'Initials': 'MP', 'LastName': 'Graas', 'Affiliation': 'International Breast Cancer Study Group and Centre Hospitalier Chrétien Clinique St Joseph, Liège, Belgium.'}, {'ForeName': 'Edda', 'Initials': 'E', 'LastName': 'Simoncini', 'Affiliation': 'International Breast Cancer Study Group and ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Kamby', 'Affiliation': 'Danish Breast Cancer Group and Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Scottish Cancer Trials Breast Group and The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Gavilá', 'Affiliation': 'SOLTI Group and Fundación Instituto Valenciano de Oncologia, Valencia, Spain.'}, {'ForeName': 'Katsumasa', 'Initials': 'K', 'LastName': 'Kuroi', 'Affiliation': 'Japan Breast Cancer Research Group and Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': 'Austrian Breast & Colorectal Cancer Study Group and Department of Obstetrics and Gynecology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Müller', 'Affiliation': 'Chilean Cooperative Group for Oncologic Research, Providencia, Santiago, Chile.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': ""O'Reilly"", 'Affiliation': 'Cancer Trials Ireland and Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Di Lauro', 'Affiliation': 'International Breast Cancer Study Group and Centro di Riferimento Oncologico di Aviano, Aviano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gombos', 'Affiliation': 'Medical Oncology Clinic, Institute Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ruhstaller', 'Affiliation': 'Swiss Group for Clinical Cancer Research, International Breast Cancer Study Group, and Breast Center St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Burstein', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ribi', 'Affiliation': 'International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Bernhard', 'Affiliation': 'International Breast Cancer Study Group Coordinating Center, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'European Institute of Oncology, Milan, Italy; International Breast Cancer Study Group Central Pathology Office and University of Milan, Milan, Italy.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Maibach', 'Affiliation': 'International Breast Cancer Study Group Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Rabaglio-Poretti', 'Affiliation': 'International Breast Cancer Study Group, Inselspital, Bern, Switzerland; Bern University Hospital, Inselspital, Bern, Switzerland.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Frontier Science & Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': 'International Breast Cancer Study Group and Hospital of Prato-AUSL Toscana Centro, Istituto Toscano Tumori, Prato, Italy.'}, {'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Boston, MA, USA; Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'International Breast Cancer Study Group, Milan, Italy; European Institute of Oncology, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30715-5']
753,31601123,Effectiveness of a multidisciplinary parent training program for children with developmental disabilities: A single-blind randomized waitlist controlled trial.,"This study aimed to evaluate the effectiveness of a multidisciplinary parent training program, Promoting Holistic Development of Young Kids (Poly Kids), using a single-blind randomized waitlist controlled design. The participants included 218 parents of children with developmental disabilities (DD) (intervention group = 107 and waitlist control group = 111). The primary outcomes were child learning, expressive language, fine and gross motor skills (based on individual assessment by respective blinded professionals), and parental reports of child behavior problems. The parents in the intervention group reported significantly lower child behavior problems ( d = .34), higher child task motivation ( d = .63), and lower parenting stress post-intervention ( d = .25), while the children in the intervention group produced significantly more words post-intervention ( d = .82). McNemar test results were significant for movement out of the clinical range in child behavior problems and cognitive skills in the intervention group, but not the control group. The results provided initial evidence on the effectiveness of this train-the-trainer program in supporting families with preschool children with DD in terms of child behavior problems, expressive language, cognitive skills, task motivation, and parenting stress.",2020,"The parents in the intervention group reported significantly lower child behavior problems ( d = .34), higher child task motivation (","['Young Kids (Poly Kids', 'children with developmental disabilities', 'participants included 218 parents of children with developmental disabilities (DD) (intervention group = 107 and waitlist control group = 111', 'families with preschool children with DD']",['multidisciplinary parent training program'],"['child behavior problems, expressive language, cognitive skills, task motivation, and parenting stress', 'child behavior problems', 'child learning, expressive language, fine and gross motor skills (based on individual assessment by respective blinded professionals), and parental reports of child behavior problems', 'child behavior problems and cognitive skills', 'child task motivation']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",218.0,0.0407992,"The parents in the intervention group reported significantly lower child behavior problems ( d = .34), higher child task motivation (","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Leung', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Lau', 'Affiliation': 'Department of Chinese and Bilingual Studies, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Tamis W', 'Initials': 'TW', 'LastName': 'Pin', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",Journal of child health care : for professionals working with children in the hospital and community,['10.1177/1367493519880447']
754,31851001,Are Postoperative Intravenous Antibiotics Indicated After Laparoscopic Appendicectomy for Simple Appendicitis? A Prospective Double-blinded Randomized Controlled Trial.,"BACKGROUND
There is limited evidence for the use of postoperative antibiotics for simple appendicitis (SA) in children. Our aim was to conduct a prospective double-blinded randomized controlled trial to investigate this after a laparoscopic appendicectomy.
METHODS
Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution. Patients were randomized intraoperatively to receive either 2 postoperative intravenous doses of placebo or antibiotics (Abx). All patients received a dose of Abx at induction of anesthesia. Primary outcome was the incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation. Data are reported as number of cases (%), median (range), relative risk, and analyzed using Mann Whitney U test, Chi-square test, as appropriate, a P-value ≤0.05 was considered significant.
RESULTS
A total of 304 patients were randomized. Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis. One hundred twenty-two patients received placebo and 121 Intravenous Abx. There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7). There was also no difference in the preoperative blood results. A total of 9 WIs occurred: 8/122 (6.6%) placebo versus 1/121 (0.8%) Abx, P = 0.01 [relative risk for WI 1.83 (95% confidence interval: 1.145-2.201)]. There were no intra-abdominal abscess in either groups.
CONCLUSIONS
This prospective randomized double blinded randomized controlled trial has revealed a significant decrease in WI rates by giving 2 postoperative intravenous doses of Abx, suggesting postoperative Abx are of benefit in SA.",2019,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","['simple appendicitis (SA) in children', '304 patients were randomized', 'One hundred twenty-two patients received', 'Sixty-one were subsequently excluded due to protocol violations or recruitment errors; therefore, 243 were included in the final analysis', 'Following ethical approval, children (≤16 years) undergoing appendicectomy were recruited at a single institution']","['Laparoscopic Appendicectomy', 'placebo or antibiotics (Abx', 'placebo', 'laparoscopic appendicectomy']","['intra-abdominal abscess', 'WI rates', 'postoperative length of stay in a hospital', 'incidence of postoperative wound infection (WI), and secondary outcome was the incidence of intra-abdominal abscess formation']","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0243001', 'cui_str': 'Abscess, Intra-Abdominal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}]",243.0,0.816238,"There was no difference between the sex (50F/72 M vs 47F/74 M, P = 0.8), median age (12.4 vs 12.2 years, P = 0.5), and postoperative length of stay in a hospital (27.2 vs 25.6 hours, P = 0.7).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mennie', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Gayathri', 'Initials': 'G', 'LastName': 'Panabokke', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Sharman Tan', 'Initials': 'ST', 'LastName': 'Tanny', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Pediatrics, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ferguson', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}, {'ForeName': 'Ramesh M', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Pediatric Surgery, Urology & Surgical Simulation, Monash Children's Hospital, Melbourne, Australia.""}]",Annals of surgery,['10.1097/SLA.0000000000003732']
755,29258499,SMS education for the promotion of diabetes self-management in low & middle income countries: a pilot randomized controlled trial in Egypt.,"BACKGROUND
Due to the ubiquity of mobile phones in low and middle income countries, we aimed to examine the feasibility of SMS education among diabetic patients in Egypt, and assess the impact of educational text messages, compared to traditional paper-based methods, on glycemic control and self-management behaviors.
METHODS
We conducted a 12-week randomized controlled trial at Misr University for Science & Technology hospital in Cairo-Egypt. Known as MUST diabetes awareness program, patients were included if they had diabetes, owned a mobile phone, and could read SMS messages or lived with someone that could read for them. Intervention patients received daily messages and weekly reminders addressing various diabetes care categories. We expected greater improvement in their glycemic control compared to controls who only received paper-based educational material. The primary outcome was the change in HbA1c, measured by the difference between endpoint and baseline values and by the number of patients who experienced at least 1% reduction from baseline to endpoint. Key secondary outcomes included blood glucose levels, body weight, treatment and medication adherence, self-efficacy, and diabetes knowledge. Data were analyzed using ANCOVA, chi-square, and t-tests.
RESULTS
Thirty four intervention and 39 control patients completed the study. Over 12 weeks, 3880 messages were sent. Each intervention patient received 84 educational and 12 reminder messages plus one welcome message. Our primary outcome did not differ significantly (Δ 0.290; 95% CI -0.402 to 0.983; p = 0.406) between groups after 3 months, demonstrating a mean drop of -0.69% and -1.05% in the control and intervention group respectively. However, 16 intervention patients achieved the targeted 1% drop versus only 6 controls, suggesting clear association between study group and 1% HbA1c reductions (chi-square = 8.655; df = 1; p = 0.003). Secondary outcomes seemed in favor of intervention patients at endpoint, with considerable improvements in treatment and medication adherence, self-efficacy, and knowledge scores. Participants also indicated full satisfaction with the program.
CONCLUSIONS
SMS education is a feasible and acceptable method for improving glycemic control and self-management behaviors among Egyptian diabetics. However, whether it is more effective than traditional paper-based methods needs further investigation.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02868320 . Registered 9 August 2016. Retrospectively registered.",2017,"CONCLUSIONS
SMS education is a feasible and acceptable method for improving glycemic control and self-management behaviors among Egyptian diabetics.","['Thirty four intervention and 39 control patients completed the study', 'low & middle income countries', 'Egyptian diabetics', 'diabetic patients in Egypt', 'Misr University for Science & Technology hospital in Cairo-Egypt']","['84 educational and 12 reminder messages plus one welcome message', 'SMS education', 'daily messages and weekly reminders addressing various diabetes care categories']","['treatment and medication adherence, self-efficacy, and knowledge scores', 'blood glucose levels, body weight, treatment and medication adherence, self-efficacy, and diabetes knowledge', 'change in HbA1c', 'glycemic control and self-management behaviors']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0013715', 'cui_str': 'Arab Republic of Egypt'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",3880.0,0.135098,"CONCLUSIONS
SMS education is a feasible and acceptable method for improving glycemic control and self-management behaviors among Egyptian diabetics.","[{'ForeName': 'Haitham', 'Initials': 'H', 'LastName': 'Abaza', 'Affiliation': 'Peter L. Reichertz Institute for Medical Informatics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany. haitham.abaza@plri.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marschollek', 'Affiliation': 'Peter L. Reichertz Institute for Medical Informatics, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.'}]",BMC public health,['10.1186/s12889-017-4973-5']
756,31592824,Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.,"BACKGROUND
Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis.
OBJECTIVE
Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH).
METHODS
This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs.
RESULTS
At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss.
CONCLUSION
Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03612570.",2020,"At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome.","['Sebaceous Gland Hyperplasia', '72 subjects resulting in a total of 222 treated lesions']","['nsPEF', 'Nanosecond Pulsed Electric Field Treatment', 'local anesthetic, high-intensity, ultrashort pulses of electrical energy']","['tolerability and effectiveness', 'Safety and Efficacy']","[{'cui': 'C0406484', 'cui_str': 'Sebaceous hyperplasia (disorder)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0337037', 'cui_str': 'Electric field (physical force)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",72.0,0.0271499,"At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome.","[{'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Munavalli', 'Affiliation': 'Laser & Vein Specialists, Charlotte, North Carolina.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Zelickson', 'Affiliation': 'Zel Skin and Laser Specialists, Minneapolis, Minnesota.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Selim', 'Affiliation': 'Zel Skin and Laser Specialists, Minneapolis, Minnesota.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Kilmer', 'Affiliation': 'Laser & Skin Surgery Center of Northern California, Sacramento, California.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Rohrer', 'Affiliation': 'Skin Care Physicians, Chestnut, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Newman', 'Affiliation': 'Premier Plastic Surgery, San Mateo, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Jauregui', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Knape', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ebbers', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Darrin', 'Initials': 'D', 'LastName': 'Uecker', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nuccitelli', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002154']
757,31811128,Resolving the cause of recurrent Plasmodium vivax malaria probabilistically.,"Relapses arising from dormant liver-stage Plasmodium vivax parasites (hypnozoites) are a major cause of vivax malaria. However, in endemic areas, a recurrent blood-stage infection following treatment can be hypnozoite-derived (relapse), a blood-stage treatment failure (recrudescence), or a newly acquired infection (reinfection). Each of these requires a different prevention strategy, but it was not previously possible to distinguish between them reliably. We show that individual vivax malaria recurrences can be characterised probabilistically by combined modelling of time-to-event and genetic data within a framework incorporating identity-by-descent. Analysis of pooled patient data on 1441 recurrent P. vivax infections in 1299 patients on the Thailand-Myanmar border observed over 1000 patient follow-up years shows that, without primaquine radical curative treatment, 3 in 4 patients relapse. In contrast, after supervised high-dose primaquine only 1 in 40 relapse. In this region of frequent relapsing P. vivax, failure rates after supervised high-dose primaquine are significantly lower (∼3%) than estimated previously.",2019,"Analysis of pooled patient data on 1441 recurrent P. vivax infections in 1299 patients on the Thailand-Myanmar border observed over 1000 patient follow-up years shows that, without primaquine radical curative treatment, 3 in 4 patients relapse.",['1299 patients on the Thailand-Myanmar border observed over 1000\xa0patient follow-up years'],"['primaquine', 'primaquine radical curative']",['failure rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0710095,"Analysis of pooled patient data on 1441 recurrent P. vivax infections in 1299 patients on the Thailand-Myanmar border observed over 1000 patient follow-up years shows that, without primaquine radical curative treatment, 3 in 4 patients relapse.","[{'ForeName': 'Aimee R', 'Initials': 'AR', 'LastName': 'Taylor', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, 02115, USA. ataylor@hsph.harvard.edu.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand. jwatowatson@gmail.com.'}, {'ForeName': 'Cindy S', 'Initials': 'CS', 'LastName': 'Chu', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, OX3 7FZ, UK.'}, {'ForeName': 'Kanokpich', 'Initials': 'K', 'LastName': 'Puaprasert', 'Affiliation': 'Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Jureeporn', 'Initials': 'J', 'LastName': 'Duanguppama', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Nosten', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, OX3 7FZ, UK.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Neafsey', 'Affiliation': 'Broad Institute of MIT and Harvard, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Caroline O', 'Initials': 'CO', 'LastName': 'Buckee', 'Affiliation': 'Center for Communicable Disease Dynamics, Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, 02115, USA.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Imwong', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, 10400, Thailand. nickwdt@tropmedres.ac.'}]",Nature communications,['10.1038/s41467-019-13412-x']
758,25711328,Factors associated with neurocognitive test performance at baseline: a substudy of the INSIGHT Strategic Timing of AntiRetroviral Treatment (START) trial.,"OBJECTIVES
We describe neuropsychological test performance (NP) in antiretroviral treatment (ART)-naïve HIV-positive individuals with CD4 cell counts above 500 cells/μL.
METHODS
In a neurology substudy of the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) Strategic Timing of AntiRetroviral Treatment (START) study, eight neurocognitive tests were administered. The primary measure of NP was the quantitative NP z-score (QNPZ-8), the average of the z-scores for the eight tests. Associations of baseline factors with QNPZ-8 scores were assessed by multiple regression. Mild neurocognitive impairment (NCI) was defined as z-scores < -1 in at least two of six cognitive domains.
RESULTS
A total of 608 participants had a median age of 34 years; 11% were women and 15% were black; the median time since HIV diagnosis was 0.9 years; the median CD4 cell count was 633 cells/μL; 19.9% had mild NCI. Better NP was independently associated with younger age, being white, higher body mass index (0.10 per 10 kg/m(2) higher), and higher haematocrit percentage (0.19 per 10% higher). Worse NP was associated with longer time since HIV diagnosis (-0.17 per 10 years), diabetes (-0.29) and higher Framingham risk score (-0.15 per 10 points higher). QNPZ-8 scores differed significantly between geographical locations, with the lowest scores in Brazil and Argentina/Chile.
CONCLUSIONS
This is the largest study of NP in ART-naïve HIV-positive adults with CD4 counts > 500 cells/μL. Demographic factors and diabetes were most strongly associated with NP. Unmeasured educational/sociocultural factors may explain geographical differences. Poorer NP was independently associated with longer time since HIV diagnosis, suggesting that untreated HIV infection might deleteriously affect NP, but the effect was small.",2015,"Better NP was independently associated with younger age, being white, higher body mass index (0.10 per 10 kg/m(2) higher), and higher haematocrit percentage (0.19 per 10% higher).",['608 participants had a median age of 34 years'],['antiretroviral treatment'],"['neuropsychological test performance (NP', 'longer time since HIV diagnosis', 'median CD4 cell count', 'Mild neurocognitive impairment (NCI', 'Framingham risk score', 'QNPZ-8 scores', 'quantitative NP\u2005z-score (QNPZ-8), the average of the z-scores', 'median time since HIV diagnosis', 'haematocrit percentage']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0027902', 'cui_str': 'Neuropsychologic Tests'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}]",608.0,0.465192,"Better NP was independently associated with younger age, being white, higher body mass index (0.10 per 10 kg/m(2) higher), and higher haematocrit percentage (0.19 per 10% higher).","[{'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Wright', 'Affiliation': 'Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, Victoria, Australia; Burnet Institute, Melbourne, Victoria, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Grund', 'Affiliation': ''}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Cysique', 'Affiliation': ''}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Robertson', 'Affiliation': ''}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Brew', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Shlay', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Winston', 'Affiliation': ''}, {'ForeName': 'T R H', 'Initials': 'TR', 'LastName': 'Read', 'Affiliation': ''}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Price', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HIV medicine,['10.1111/hiv.12238']
759,32412181,Live lectures and videos do not differ in relation to learning outcomes of dental ergonomics.,"OBJECTIVES
This study aimed to compare the knowledge attained by third-year dental students in physical ergonomics altering live lectures and videos in teaching. The second aim was to investigate implementation of the theoretical knowledge on ergonomics into practice.
MATERIAL AND METHODS
Forty-five students divided into two groups attended a live lecture (45 min) or viewed videos (45 min). After the first teaching session, the groups changed parts. All students answered a questionnaire with 13 true or false-questions on ergonomics at baseline and immediately after both teaching sessions. Friedman's test and Wilcoxon signed rank test were used to compare questionnaire scores of the student groups. Additionally, we photographed 17 randomly selected students 3 months after baseline during a simulation workshop on endodontics. We analyzed the photographs for ergonomic postures using a specific 12-point checklist.
RESULTS
At baseline, no difference in the knowledge between the two groups was discovered, when both scored 72%. After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group). After the second teaching session, the scores were similar in both groups. Overall all improvement in both groups was significant (p < .001). The photograph analysis showed half of the postures being in accord with the ergonomic guidelines.
CONCLUSIONS
Both live lectures and videos showed similar outcomes in teaching ergonomics. Implementation of the knowledge on ergonomics is insufficient. Videos provide an easy-to-organize alternative to live lectures in teaching dental ergonomics. New means are needed to have dental students implement their knowledge on ergonomics into practice.",2020,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","['Forty-five students divided into two groups attended a', 'third-year dental students in physical ergonomics altering live lectures and videos in teaching']",['live lecture (45\u2009min) or viewed videos'],['questionnaire scores'],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C4505395', 'cui_str': 'Physical Ergonomics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",17.0,0.0185547,"After the first teaching session, significant improvement in both groups (p < .05) was found; and there was no statistically significant difference in the scores between the groups (88% in the lecture-first and 82% in the video-first group).","[{'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Leinonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Marja-Liisa', 'Initials': 'ML', 'LastName': 'Laitala', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Pirttilahti', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Niskanen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Pesonen', 'Affiliation': 'Infrastructure for Population Studies, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Vuokko', 'Initials': 'V', 'LastName': 'Anttonen', 'Affiliation': 'Department of Clinical Dentistry, UiT The Arctic University of Norway, Tromso, Norway.'}]",Clinical and experimental dental research,['10.1002/cre2.300']
760,28760939,Visit-to-Visit Office Blood Pressure Variability and Cardiovascular Outcomes in SPRINT (Systolic Blood Pressure Intervention Trial).,"Studies of visit-to-visit office blood pressure (BP) variability (OBPV) as a predictor of cardiovascular events and death in high-risk patients treated to lower BP targets are lacking. We conducted a post hoc analysis of SPRINT (Systolic Blood Pressure Intervention Trial), a well-characterized cohort of participants randomized to intensive (<120 mm Hg) or standard (<140 mm Hg) systolic BP targets. We defined OBPV as the coefficient of variation of the systolic BP using measurements taken during the 3-,6-, 9-, and 12-month study visits. In our cohort of 7879 participants, older age, female sex, black race, current smoking, chronic kidney disease, and coronary disease were independent determinants of higher OBPV. Use of thiazide-type diuretics or dihydropyridine calcium channel blockers was associated with lower OBPV whereas angiotensin-converting enzyme inhibitors or angiotensin receptor blocker use was associated with higher OBPV. There was no difference in OBPV in participants randomized to standard or intensive treatment groups. We found that OBPV had no significant associations with the composite end point of fatal and nonfatal cardiovascular events (n=324 primary end points; adjusted hazard ratio, 1.20; 95% confidence interval, 0.85-1.69, highest versus lowest quintile) nor with heart failure or stroke. The highest quintile of OBPV (versus lowest) was associated with all-cause mortality (adjusted hazard ratio, 1.92; confidence interval, 1.22-3.03) although the association of OBPV overall with all-cause mortality was marginal ( P =0.07). Our results suggest that clinicians should continue to focus on office BP control rather than on OBPV unless definitive benefits of reducing OBPV are shown in prospective trials.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01206062.",2017,There was no difference in OBPV in participants randomized to standard or intensive treatment groups.,"['participants randomized to intensive (<120 mm Hg) or standard', '7879 participants, older age, female sex, black race, current smoking, chronic kidney disease, and coronary disease']","['thiazide-type diuretics or dihydropyridine calcium channel blockers', 'OBPV']","['highest quintile of OBPV', 'OBPV', 'fatal and nonfatal cardiovascular events', 'heart failure or stroke', 'blood pressure (BP) variability (OBPV']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}]","[{'cui': 'C0541746', 'cui_str': 'Thiazides'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C1153433', 'cui_str': 'Calcium channel'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",7879.0,0.132101,There was no difference in OBPV in participants randomized to standard or intensive treatment groups.,"[{'ForeName': 'Tara I', 'Initials': 'TI', 'LastName': 'Chang', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Parati', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Raj', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Riessen', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shapiro', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Stergiou', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsioufis', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Whittle', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.).'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Papademetriou', 'Affiliation': 'From the Division of Nephrology, Stanford University School of Medicine, CA (T.I.C., G.M.C.); Wake Forest School of Medicine, Winston-Salem, NC (D.M.R.); Division of Nephrology and Hypertension, University of Utah and Renal Section, Veterans Affairs Salt Lake City Health Care System (A.K.C.); Memphis Veterans Affairs Medical Center, TN (W.C.C.); Division of Cardiovascular Disease and Hypertension, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ (W.J.K.); Department of Medicine and Surgery, University of Milano-Bicocca, Italy (G.P.); St. Luke Hospital, Italian Auxology Institute, Milan, Italy (G.P.); Division of Renal Diseases and Hypertension, George Washington University, Washington, DC (D.R.); Intermountain Medical Center, Murray, UT (E.R.); Department of Cardiovascular Diseases, Mayo Clinic, Jacksonville, FL (B.S.); School of Medicine, National and Kapodistrian University of Athens, Greece (G.S.S., K.T.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (R.R.T.); Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA (P.K.W.); Primary Care Division, Clement J. Zablocki VA Medical Center, Milwaukee, WI (J.W.); Division of Nephrology and Hypertension, Case Western Reserve University, University Hospitals Cleveland Medical Center, OH (J.T.W.); and Department of Veterans Affairs and Georgetown University, Washington, DC (V.P.). vpapademetriou@va.gov.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.117.09788']
761,28460091,The impact of home care nurses' numeracy and graph literacy on comprehension of visual display information: implications for dashboard design.,"Objective
To explore home care nurses' numeracy and graph literacy and their relationship to comprehension of visualized data.
Materials and Methods
A multifactorial experimental design using online survey software. Nurses were recruited from 2 Medicare-certified home health agencies. Numeracy and graph literacy were measured using validated scales. Nurses were randomized to 1 of 4 experimental conditions. Each condition displayed data for 1 of 4 quality indicators, in 1 of 4 different visualized formats (bar graph, line graph, spider graph, table). A mixed linear model measured the impact of numeracy, graph literacy, and display format on data understanding.
Results
In all, 195 nurses took part in the study. They were slightly more numerate and graph literate than the general population. Overall, nurses understood information presented in bar graphs most easily (88% correct), followed by tables (81% correct), line graphs (77% correct), and spider graphs (41% correct). Individuals with low numeracy and low graph literacy had poorer comprehension of information displayed across all formats. High graph literacy appeared to enhance comprehension of data regardless of numeracy capabilities.
Discussion and Conclusion
Clinical dashboards are increasingly used to provide information to clinicians in visualized format, under the assumption that visual display reduces cognitive workload. Results of this study suggest that nurses' comprehension of visualized information is influenced by their numeracy, graph literacy, and the display format of the data. Individual differences in numeracy and graph literacy skills need to be taken into account when designing dashboard technology.",2018,"Overall, nurses understood information presented in bar graphs most easily (88% correct), followed by tables (81% correct), line graphs (77% correct), and spider graphs (41% correct).","['195 nurses took part in the study', 'Nurses were recruited from 2 Medicare-certified home health agencies']",[],"['numerate and graph literate', 'Numeracy and graph literacy']","[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0019859', 'cui_str': 'Home Health Agencies'}]",[],"[{'cui': 'C0023864', 'cui_str': 'Literacy'}]",195.0,0.0417502,"Overall, nurses understood information presented in bar graphs most easily (88% correct), followed by tables (81% correct), line graphs (77% correct), and spider graphs (41% correct).","[{'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Dowding', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Merrill', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Onorato', 'Affiliation': 'Center for Home Care Policy and Research, Visiting Nurse Service of New York, New York, NY, USA.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Barrón', 'Affiliation': 'Center for Home Care Policy and Research, Visiting Nurse Service of New York, New York, NY, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Rosati', 'Affiliation': 'VNA Health Group, Red Bank, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Center for Home Care Policy and Research, Visiting Nurse Service of New York, New York, NY, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocx042']
762,31592915,Combination Therapy of Microneedle Fractional Radiofrequency and Topical Poly-Lactic Acid for Acne Scars: A Randomized Controlled Split-Face Study.,"BACKGROUND
Acne scarring occurs at a young age and causes distress for many patients. Various treatment modalities have been tried.
OBJECTIVE
This study investigated the efficacy of combination therapy with topical poly-lactic acid and microneedle fractional radiofrequency (MFRF) for acne scars.
MATERIALS AND METHODS
Patients with acne scars on both the cheeks were included. Poly-lactic acid was applied to the acne scars on one side of the face before MFRF treatment. The other side of the face was treated with MFRF and normal saline. Patients received 3 treatment sessions and were evaluated based on visual assessment and patient satisfaction. After the last treatment, objective scar assessment of scar smoothness, size, brightness, and overall improvement was performed.
RESULTS
Both acne scar assessment scores and patient satisfaction were better with combination therapy (p = .036 and p = .009, respectively) than with monotherapy. Combination therapy resulted in significantly better efficacy for scar smoothness (p < .001), scar size (p = .003), and overall improvement (p < .001), but not for brightness (p = .151).
CONCLUSION
Combination therapy resulted in significantly better clinical outcomes, including better scar smoothness and smaller scar size. Therefore, we believe this combination therapy is a safe and effective treatment for acne scars.",2020,"Combination therapy resulted in significantly better efficacy for scar smoothness (p < .001), scar size (p = .003), and overall improvement (p < .001), but not for brightness (p = .151).
","['Acne Scars', 'Patients with acne scars on both the cheeks were included']","['Microneedle Fractional Radiofrequency and Topical Poly-Lactic Acid', 'topical poly-lactic acid and microneedle fractional radiofrequency (MFRF', 'Poly-lactic acid', 'MFRF and normal saline']","['efficacy for scar smoothness', 'scar smoothness and smaller scar size', 'scar size', 'acne scar assessment scores and patient satisfaction', 'objective scar assessment of scar smoothness, size, brightness, and overall improvement']","[{'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007966', 'cui_str': 'Bucca'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0064582', 'cui_str': 'Lactic acid'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0423783', 'cui_str': 'Acne scar (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0325954,"Combination therapy resulted in significantly better efficacy for scar smoothness (p < .001), scar size (p = .003), and overall improvement (p < .001), but not for brightness (p = .151).
","[{'ForeName': 'Min K', 'Initials': 'MK', 'LastName': 'An', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}, {'ForeName': 'Eun H', 'Initials': 'EH', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}, {'ForeName': 'Suk B', 'Initials': 'SB', 'LastName': 'Suh', 'Affiliation': 'SeoASong Dermatologic Clinic, Seoul, Korea.'}, {'ForeName': 'Eun J', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}, {'ForeName': 'Kwang H', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, College of Medicine, Hallym University, Anyang, Korea.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002175']
763,31867713,Impact of Baseline Fatigue on a Physical Activity Intervention to Prevent Mobility Disability.,"OBJECTIVES
Our aim was to examine the impacts of baseline fatigue on the effectiveness of a physical activity (PA) intervention to prevent major mobility disability (MMD) and persistent major mobility disability (PMMD) in participants from the Lifestyle Interventions and Independence for Elders (LIFE) study.
DESIGN
Prospective cohort of individuals aged 65 years or older undergoing structured PA intervention or health education (HE) for a mean of 2.6 years.
SETTING
LIFE was a multicenter eight-site randomized trial that compared the efficacy of a structured PA intervention with an HE program in reducing the incidence of MMD.
PARTICIPANTS
Study participants (N = 1591) at baseline were 78.9 ± 5.2 years of age, with low PA and at risk for mobility impairment.
MEASUREMENTS
Self-reported fatigue was assessed using the modified trait version of the Exercise-Induced Feelings Inventory, a six-question scale rating energy levels in the past week. Responses ranged from 0 (none of the time) to 5 (all of the time). Total score was calculated by averaging across questions; baseline fatigue was based on the median split: 2 or higher = more fatigue (N = 856) and lower than 2 = less fatigue (N = 735). Participants performed a usual-paced 400-m walk every 6 months. We defined incident MMD as the inability to walk 400-m at follow-up visits; PMMD was defined as two consecutive walk failures. Cox proportional hazard models quantified the risk of MMD and PMMD in PA vs HE stratified by baseline fatigue adjusted for covariates.
RESULTS
Among those with higher baseline fatigue, PA participants had a 29% and 40% lower risk of MMD and PMMD, respectively, over the trial compared with HE (hazard ratio [HR] for MMD = .71; 95% confidence interval [CI] = .57-.90; P = .004) and PMMD (HR = .60; 95% CI = .44-.82; P = .001). For those with lower baseline fatigue, no group differences in MMD (P = .36) or PMMD (P = .82) were found. Results of baseline fatigue by intervention interaction was MMD (P = .18) and PMMD (P = .05).
CONCLUSION
A long-term moderate intensity PA intervention was particularly effective at preserving mobility in older adults with higher levels of baseline fatigue. J Am Geriatr Soc 68:619-624, 2020.",2020,A long-term moderate intensity PA intervention was particularly effective at preserving mobility in older adults with higher levels of baseline fatigue.,"['older adults with higher levels of baseline fatigue', 'individuals aged 65\u2009years or older undergoing structured PA intervention or health education (HE) for a mean of 2.6\u2009years', 'participants from the Lifestyle Interventions and Independence for Elders (LIFE) study', 'Study participants (N\u2009=\u20091591) at baseline were 78.9\u2009±\u20095.2\u2009years of age, with low PA and at risk for mobility impairment']","['physical activity (PA) intervention', 'structured PA intervention with an HE program', 'intensity PA intervention', 'Physical Activity Intervention']","['Total score', 'MMD', 'risk of MMD and PMMD', 'Self-reported fatigue', 'modified trait version of the Exercise-Induced Feelings Inventory, a six-question scale rating energy levels', 'major mobility disability (MMD) and persistent major mobility disability (PMMD', 'PMMD', 'Mobility Disability']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0222045'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",735.0,0.0948704,A long-term moderate intensity PA intervention was particularly effective at preserving mobility in older adults with higher levels of baseline fatigue.,"[{'ForeName': 'Nancy W', 'Initials': 'NW', 'LastName': 'Glynn', 'Affiliation': 'Center for Aging and Population Health, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Gmelin', 'Affiliation': 'Center for Aging and Population Health, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Santanasto', 'Affiliation': 'Center for Aging and Population Health, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Lovato', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest University School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Brittney S', 'Initials': 'BS', 'LastName': 'Lange-Maia', 'Affiliation': 'Department of Preventive Medicine and Center for Community Health Equity, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Department of Internal Medicine, Section on Gerontology and Geriatric Medicine, Sticht Center on Aging, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Fielding', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Manini', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Valerie H', 'Initials': 'VH', 'LastName': 'Myers', 'Affiliation': 'Klein Buendel, Inc, Golden, Colorado.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'de Rekeneire', 'Affiliation': 'Centre Muraz, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pahor', 'Affiliation': 'Institute on Aging, Department of Aging and Geriatric Research, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Health Research & Policy, and the Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Newman', 'Affiliation': 'Center for Aging and Population Health, Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Geriatrics Society,['10.1111/jgs.16274']
764,31583699,The effect of melatonin on ultrasound markers of follicular development: A double-blind placebo-controlled randomised trial.,"BACKGROUND
Melatonin is a potent oxygen scavenger and is capable of altering blood flow in various vascular beds.
AIMS
We aimed to determine the effect of melatonin on ovarian vascular indices during ovarian stimulation for in vitro fertilisation (IVF).
MATERIALS AND METHODS
This is a pilot double-blind placebo-controlled randomised trial. Sixty-nine women (mean age 35.8 ± 4.3 years) undergoing their first cycle of IVF were randomised to receive either placebo, 2, 4 or 8 mg of melatonin, twice a day. Each participant underwent a transvaginal ultrasound at days 6-10 assessing follicular number and size. The vascularisation index (VI), flow index (FI) and vascularisation-flow index (VFI) were measured. These indices were then correlated with embryological outcomes. Informed consent was obtained from participants. This trial was registered with the Australia New Zealand Clinical Trials Registry (ACTRN12613001317785).
RESULTS
The number of follicles did not differ between groups (P = 0.4). There were no differences in the VI (P = 0.4), FI (P = 0.1) or VFI (P = 0.3) in the right ovary or the FI (P = 0.3) or VFI (P = 0.3) in the left ovary between groups. When comparing placebo to any dose of melatonin, there were no differences in any measured parameter. While there was correlation between the number of follicles on ultrasound and all measured embryological outcomes, there was no correlation between ovarian vascular indices and these important clinical outcomes.
CONCLUSIONS
Melatonin does not appear to change ovarian vascular indices during ovarian stimulation. In addition, such vascular indices cannot predict the number or quality of oocytes or embryos obtained in an IVF cycle. These findings require confirmation in future larger studies.",2020,"There were no differences in the VI (P = 0.4), FI (P = 0.1) or VFI (P = 0.3) in the right ovary or the FI (P = 0.3) or VFI (P = 0.3) in the left ovary between groups.",['Sixty-nine women (mean age 35.8\xa0±\xa04.3\xa0years) undergoing their first cycle of IVF'],"['transvaginal ultrasound', 'placebo', 'Melatonin', 'melatonin', 'placebo, 2, 4 or 8\xa0mg of melatonin']","['ultrasound markers of follicular development', 'vascularisation index (VI), flow index (FI) and vascularisation-flow index (VFI', 'number or quality of oocytes or embryos', 'ovarian vascular indices', 'number of follicles']","[{'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0439682', 'cui_str': 'Follicular (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0027686', 'cui_str': 'Pathologic Neovascularization'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0029045', 'cui_str': 'Ovocytes'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}]",69.0,0.797119,"There were no differences in the VI (P = 0.4), FI (P = 0.1) or VFI (P = 0.3) in the right ovary or the FI (P = 0.3) or VFI (P = 0.3) in the left ovary between groups.","[{'ForeName': 'Shavi', 'Initials': 'S', 'LastName': 'Fernando', 'Affiliation': 'The Ritchie Centre, Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Euan Morrison', 'Initials': 'EM', 'LastName': 'Wallace', 'Affiliation': 'The Ritchie Centre, Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luk', 'Initials': 'L', 'LastName': 'Rombauts', 'Affiliation': 'The Ritchie Centre, Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Monash Ultrasound for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': 'Monash Ultrasound for Women, Melbourne, Victoria, Australia.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Vollenhoven', 'Affiliation': 'The Ritchie Centre, Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lolatgis', 'Affiliation': 'Monash IVF, Melbourne, Victoria, Australia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hope', 'Affiliation': 'Monash IVF, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Monash IVF, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lawrence', 'Affiliation': ""Monash Women's, Monash Health, Melbourne, Victoria, Australia.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lawrence', 'Affiliation': ""Monash Women's, Monash Health, Melbourne, Victoria, Australia.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'Monash IVF, Melbourne, Victoria, Australia.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Leong', 'Affiliation': 'Monash IVF, Melbourne, Victoria, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Thomas', 'Affiliation': ""Monash Women's, Monash Health, Melbourne, Victoria, Australia.""}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'da Silva Costa', 'Affiliation': 'The Ritchie Centre, Department of Obstetrics and Gynaecology, Monash University, Melbourne, Victoria, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13074']
765,28461207,"Efficacy and safety of ridinilazole compared with vancomycin for the treatment of Clostridium difficile infection: a phase 2, randomised, double-blind, active-controlled, non-inferiority study.","BACKGROUND
Clostridium difficile infection is the most common health-care-associated infection in the USA. We assessed the safety and efficacy of ridinilazole versus vancomycin for treatment of C difficile infection.
METHODS
We did a phase 2, randomised, double-blind, active-controlled, non-inferiority study. Participants with signs and symptoms of C difficile infection and a positive diagnostic test result were recruited from 33 centres in the USA and Canada and randomly assigned (1:1) to receive oral ridinilazole (200 mg every 12 h) or oral vancomycin (125 mg every 6 h) for 10 days. The primary endpoint was achievement of a sustained clinical response, defined as clinical cure at the end of treatment and no recurrence within 30 days, which was used to establish non-inferiority (15% margin) of ridinilazole versus vancomycin. The primary efficacy analysis was done on a modified intention-to-treat population comprising all individuals with C difficile infection confirmed by the presence of free toxin in stool who were randomly assigned to receive one or more doses of the study drug. The study is registered with ClinicalTrials.gov, number NCT02092935.
FINDINGS
Between June 26, 2014, and August 31, 2015, 100 patients were recruited; 50 were randomly assigned to receive ridinilazole and 50 to vancomycin. 16 patients did not complete the study, and 11 discontinued treatment early. The primary efficacy analysis included 69 patients (n=36 in the ridinilazole group; n=33 in the vancomycin group). 24 of 36 (66·7%) patients in the ridinilazole group versus 14 of 33 (42·4%) of those in the vancomycin group had a sustained clinical response (treatment difference 21·1%, 90% CI 3·1-39·1, p=0·0004), establishing the non-inferiority of ridinilazole and also showing statistical superiority at the 10% level. Ridinilazole was well tolerated, with an adverse event profile similar to that of vancomycin: 82% (41 of 50) of participants reported adverse events in the ridinilazole group and 80% (40 of 50) in the vancomycin group. There were no adverse events related to ridinilazole that led to discontinuation.
INTERPRETATION
Ridinilazole is a targeted-spectrum antimicrobial that shows potential in treatment of initial C difficile infection and in providing sustained benefit through reduction in disease recurrence. Further clinical development is warranted.
FUNDING
Wellcome Trust and Summit Therapeutics.",2017,"There were no adverse events related to ridinilazole that led to discontinuation.
","['Between June 26, 2014, and August 31, 2015', 'Clostridium difficile infection', '69 patients (n=36 in the ridinilazole group; n=33 in the vancomycin group', 'Participants with signs and symptoms of C difficile infection and a positive diagnostic test result were recruited from 33 centres in the USA and Canada and randomly assigned (1:1) to receive', '100 patients were recruited; 50', '16 patients did not complete the study, and 11 discontinued treatment early']","['ridinilazole', 'ridinilazole and 50 to vancomycin', 'ridinilazole versus vancomycin', 'oral vancomycin', 'oral ridinilazole', 'vancomycin', 'Ridinilazole']","['safety and efficacy', 'achievement of a sustained clinical response, defined as clinical cure at the end of treatment and no recurrence', 'adverse events', 'Efficacy and safety', 'sustained clinical response']","[{'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4548010', 'cui_str': 'ridinilazole'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0086143'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C4548010', 'cui_str': 'ridinilazole'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}]",100.0,0.496584,"There were no adverse events related to ridinilazole that led to discontinuation.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Vickers', 'Affiliation': 'Summit Therapeutics, Abingdon, UK. Electronic address: richard.vickers@summitplc.com.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Tillotson', 'Affiliation': 'GST Micro, Durham, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nathan', 'Affiliation': 'Idaho Falls Infectious Diseases, Idaho Falls, ID, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Hazan', 'Affiliation': 'Ventura Clinical Trials, Ventura, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pullman', 'Affiliation': 'Mercury Street Medical, Butte, MT, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lucasti', 'Affiliation': 'South Jersey Infectious Disease, Somers Point, NJ, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Deck', 'Affiliation': 'Alliance Research Centers, Laguna Hills, CA, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Yacyshyn', 'Affiliation': 'University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Benedict', 'Initials': 'B', 'LastName': 'Maliakkal', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Pesant', 'Affiliation': 'St-Jerome Medical Research, St-Jérôme, QC, Canada.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Tejura', 'Affiliation': 'Summit Therapeutics, Abingdon, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roblin', 'Affiliation': 'Summit Therapeutics, Abingdon, UK.'}, {'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Edward Hines Jr Veterans Administration Hospital and Loyola University Chicago, Stritch School of Medicine, Maywood, IL, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Microbiology, Leeds Teaching Hospitals and University of Leeds, Leeds, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(17)30235-9']
766,28505367,Effect of health information exchange on recognition of medication discrepancies is interrupted when data charges are introduced: results of a cluster-randomized controlled trial.,"Objectives
To determine the effect of health information exchange (HIE) on medication prescribing for hospital inpatients in a cluster-randomized controlled trial, and to examine the prescribing effect of availability of information from a large pharmacy insurance plan in a natural experiment.
Methods
Patients admitted to an urban hospital received structured medication reconciliation by an intervention pharmacist with (intervention) or without (control) access to a regional HIE. The HIE contained prescribing information from the largest hospitals and pharmacy insurance plan in the region for the first 10 months of the study, but only from the hospitals for the last 21 months, when data charges were imposed by the insurance plan. The primary endpoint was discrepancies between preadmission and inpatient medication regimens, and secondary endpoints included adverse drug events (ADEs) and proportions of rectified discrepancies.
Results
Overall, 186 and 195 patients were assigned to intervention and control, respectively. Patients were 60 years old on average and took a mean of 7 medications before admission. There was no difference between intervention and control in number of risk-weighted discrepancies (6.4 vs 5.8, P = .452), discrepancy-associated ADEs (0.102 vs 0.092 per admission, P = .964), or rectification of discrepancies (0.026 vs 0.036 per opportunity, P = .539). However, patients who received medication reconciliation with pharmacy insurance data available had more risk-weighted medication discrepancies identified than those who received usual care (8.0 vs 5.9, P = .038).
Discussion and Conclusion
HIE may improve outcomes of medication reconciliation. Charging for access to medication information interrupts this effect. Efforts are needed to understand and increase prescribers' rectification of medication discrepancies.",2017,"There was no difference between intervention and control in number of risk-weighted discrepancies (6.4 vs 5.8, P = .452), discrepancy-associated ADEs (0.102 vs 0.092 per admission, P = .964), or rectification of discrepancies (0.026 vs 0.036 per opportunity, P = .539).","['hospital inpatients', '186 and 195 patients', 'Patients were 60 years old on average and took a mean of 7 medications before admission', 'Methods\n\n\nPatients admitted to an urban hospital received']","['health information exchange (HIE', 'structured medication reconciliation by an intervention pharmacist with (intervention) or without (control) access to a regional HIE', 'health information exchange']","['number of risk-weighted discrepancies', 'risk-weighted medication discrepancies', 'rectification of discrepancies', 'discrepancy-associated ADEs', 'discrepancies between preadmission and inpatient medication regimens', 'adverse drug events (ADEs) and proportions of rectified discrepancies']","[{'cui': 'C0239966', 'cui_str': 'Hospital patient (finding)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0020029', 'cui_str': 'Hospitals, Metropolitan'}]","[{'cui': 'C3849995', 'cui_str': 'Medical Information Exchange'}, {'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",195.0,0.140691,"There was no difference between intervention and control in number of risk-weighted discrepancies (6.4 vs 5.8, P = .452), discrepancy-associated ADEs (0.102 vs 0.092 per admission, P = .964), or rectification of discrepancies (0.026 vs 0.036 per opportunity, P = .539).","[{'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Boockvar', 'Affiliation': 'Geriatrics Research Education and Clinical Center, James J Peters VA Medical Center, Bronx, NY, USA and Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Ho', 'Affiliation': 'Pharmacy Department, James J Peters VA Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pruskowski', 'Affiliation': 'Department of Pharmacy and Therapeutics, University of Pittsburgh School of Pharmacy, Pittsburgh, PA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'DiPalo', 'Affiliation': 'Department of Pharmacy, Montefiore Einstein Center for Heart and Vascular Care, Bronx, NY, USA.'}, {'ForeName': 'Jane J', 'Initials': 'JJ', 'LastName': 'Wong', 'Affiliation': 'Pharmacy Department, James J Peters VA Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': ""Pharmacy Department, St Joseph's Hospital, Tampa, FL, USA.""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Nebeker', 'Affiliation': 'Informatics and Computing, Veterans Health Administration, Washington, DC, USA and University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Rainu', 'Initials': 'R', 'LastName': 'Kaushal', 'Affiliation': 'Healthcare Policy and Research, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hung', 'Affiliation': 'Geriatrics Research Education and Clinical Center, James J Peters VA Medical Center, Bronx, NY, USA and Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocx044']
767,28454674,"Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial.","BACKGROUND
Cost and supply constraints are key challenges in the use of inactivated polio vaccine (IPV). Dose reduction through adsorption to aluminium hydroxide (Al) is a promising option, and establishing its effectiveness in the target population is a crucial milestone in developing IPV-Al. The aim of this clinical trial was to show the non-inferiority of three IPV-Al vaccines to standard IPV.
METHODS
In this phase 2, non-inferiority, observer-blinded, randomised, controlled, single-centre trial in the Dominican Republic, healthy infants aged 6 weeks, not previously polio vaccinated, were allocated after computer-generated randomisation by block-size of four, to receive one of four IPV formulations (three-times reduced dose [1/3 IPV-Al], five-times reduced dose [1/5 IPV-Al], ten-times reduced dose [1/10 IPV-Al], or IPV) intramuscularly in the thigh at 6, 10, and 14 weeks of age. The primary outcome was seroconversion for poliovirus types 1, 2, and 3 with titres more than or equal to four-fold higher than the estimated maternal antibody titre and more than or equal to 8 after three vaccinations. Non-inferiority was concluded if the lower two-sided 90% CI of the seroconversion rate difference between IPV-Al and IPV was greater than -10%. The safety analyses were based on the safety analysis set (randomly assigned participants who received at least one trial vaccination) and the immunogenicity analyses were based on the per-protocol population. This study is registered with ClinicalTrials.gov registration, number NCT02347423.
FINDINGS
Between Feb 2, 2015, and Sept 26, 2015, we recruited 824 infants. The per-protocol population included 820 infants; 205 were randomly assigned to receive 1/3 IPV-Al, 205 to receive 1/5 IPV-Al, 204 to receive 1/10 IPV-Al, and 206 to receive IPV. The proportion of individuals meeting the primary endpoint of seroconversion for poliovirus types 1, 2, and 3 was already high for the three IPV-Al vaccines after two vaccinations, but was higher after three vaccinations (ie, after completion of the expanded programme of immunisation schedule): 1/3 IPV-Al 98·5% (n=202, type 1), 97·6% (n=200; type 2), and 99·5% (n=204, type 3); 1/5 IPV-Al: 99·5% (n=204, type 1), 96·1% (n=197, type 2), and 98·5% (n=202, type 3); and 1/10 IPV-Al: 98·5% (n=201, type 1), 94·6% (n=193, type 2), and 99·5% (n=203, type 3). All three IPV-Al were non-inferior to IPV, with absolute differences in percentage seroconversion for each poliovirus type being greater than -10% (1/3 IPV-Al type 1, -1·46 [-3·60 to 0·10], type 2, -0·98 [-3·62 to 1·49], and type 3, -0·49 [-2·16 to 0·86]; 1/5 IPV-Al type 1, -0·49 [-2·16 to 0·86], type 2, -2·45 [-5·47 to 0·27], and type 3, -1·46 [-3·60 to 0·10]; and 1/10 IPV-Al type 1, -1·47 [-3·62 to 0·10], type 2, -3·94 [-7·28 to -0·97], and type 3, -0·49 [-2·17 to 0·86]). Three serious adverse events occurred that were unrelated to the vaccine.
INTERPRETATION
The lowest dose (1/10 IPV-Al) of the vaccine performed well both after two and three doses. Based on these results, this new vaccine is under investigation in phase 3 trials.
FUNDING
Bill & Melinda Gates Foundation.",2017,"All three IPV-Al were non-inferior to IPV, with absolute differences in percentage seroconversion for each poliovirus type being greater than -10% (1/3 IPV-Al type 1,","['Between Feb 2, 2015, and Sept 26, 2015, we recruited 824 infants', 'young infants in the Dominican Republic', '820 infants; 205', 'healthy infants aged 6 weeks, not previously polio vaccinated']","['1·46', 'IPV', 'aluminium hydroxide (Al', 'standard IPV', 'inactivated polio vaccine (IPV-Al', 'aluminium hydroxide adjuvanted vaccines']","['serious adverse events', 'seroconversion rate difference between IPV-Al and IPV', 'seroconversion for poliovirus types 1, 2, and 3 with titres', 'maternal antibody titre', 'Immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0013014', 'cui_str': 'Dominican Republic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0006322', 'cui_str': 'Human poliovirus 1'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody (substance)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.253379,"All three IPV-Al were non-inferior to IPV, with absolute differences in percentage seroconversion for each poliovirus type being greater than -10% (1/3 IPV-Al type 1,","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Rivera', 'Affiliation': 'Hospital Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Rasmus S', 'Initials': 'RS', 'LastName': 'Pedersen', 'Affiliation': 'Statens Serum Institut (SSI), Copenhagen, Denmark.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Peña', 'Affiliation': 'Hospital Maternidad Nuestra Señora de la Altagracia, Santo Domingo, Dominican Republic.'}, {'ForeName': 'Klaus J', 'Initials': 'KJ', 'LastName': 'Olsen', 'Affiliation': 'Larix A/S, Herlev, Denmark.'}, {'ForeName': 'Lars V', 'Initials': 'LV', 'LastName': 'Andreasen', 'Affiliation': 'Statens Serum Institut (SSI), Copenhagen, Denmark.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kromann', 'Affiliation': 'Statens Serum Institut (SSI), Copenhagen, Denmark.'}, {'ForeName': 'Pernille I', 'Initials': 'PI', 'LastName': 'Nielsen', 'Affiliation': 'AJ Vaccines A/S, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sørensen', 'Affiliation': 'AJ Vaccines A/S, Copenhagen, Denmark.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Dietrich', 'Affiliation': 'Statens Serum Institut (SSI), Copenhagen, Denmark.'}, {'ForeName': 'Ananda S', 'Initials': 'AS', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Thierry-Carstensen', 'Affiliation': 'Statens Serum Institut (SSI), Copenhagen, Denmark. Electronic address: btc@ssi.dk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(17)30177-9']
768,32050916,A qualitative study of the factors influencing recruitment to a pilot trial on the prevention of striae gravidarum.,"BACKGROUND
Striae gravidarum are a common occurrence in pregnancy and many women use a topical product to prevent their development or lessen their appearance if they do develop. There is a lack of evidence on the effectiveness of many of the products used by women. This study arose from challenges in recruitment to a pilot randomised trial (ISRCTN trial registration number:76992326) designed to evaluate the feasibility of a definitive trial to compare a moisturising oil to no treatment in the prevention and reduction in severity of striae gravidarum. The study reported here explored the factors influencing recruitment to that pilot trial.
METHODS
A qualitative descriptive study was undertaken involving primigravid women attending an Irish maternity hospital. Data were collected by semi-structured telephone interviews over a four-week period and analysed using the framework method of analysis. Fifteen interview transcripts were included in the analysis.
RESULTS
Four main themes consisting of twelve categories were identified from the interview data. The themes focused on women's prevention of stretch marks and their choice of anti-stretch mark product, who and what influenced that choice and influences on trial participation. In relation to influences on trial participation, the possibility of being randomised to the non- intervention or control group was a deterrent for many women.
CONCLUSIONS
The prevention of stretch marks is important to pregnant women, as is their choice of product to prevent them. Offering women the opportunity to be part of a trial that would be of low burden and would test a well-known product may optimise recruitment. However, reluctance to be randomised because of the possibility of being allocated to the non-intervention control group suggests that further work is needed in this field on how best to communicate uncertainty to potential participants.",2020,"The themes focused on women's prevention of stretch marks and their choice of anti-stretch mark product, who and what influenced that choice and influences on trial participation.","['Fifteen interview transcripts were included in the analysis', 'pregnant women', 'primigravid women attending an Irish maternity hospital']",[],[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0422794', 'cui_str': 'Irish (NMO) (ethnic group)'}, {'cui': 'C0020010', 'cui_str': 'Hospitals, Maternity'}]",[],[],15.0,0.138697,"The themes focused on women's prevention of stretch marks and their choice of anti-stretch mark product, who and what influenced that choice and influences on trial participation.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Brennan', 'Affiliation': 'School of Nursing and Midwifery, Aras Moyola, National University of Ireland Galway, Galway, H91 TK33, Ireland. miriam.brennan@nuigalway.ie.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Institute of Clinical Sciences, Block B, Queen's University Belfast, Royal Hospital, Grosvenor Road, Belfast, BT12 6BA, Northern Ireland.""}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'School of Nursing and Midwifery, Aras Moyola, National University of Ireland Galway, Galway, H91 TK33, Ireland.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Dowling', 'Affiliation': 'School of Nursing and Midwifery, Aras Moyola, National University of Ireland Galway, Galway, H91 TK33, Ireland.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-2781-x']
769,31503028,"The Effect of Stabilization Exercises Along With Self-care Training on Transverse Abdominal Activity, Pain, and Disability in Mothers With Low Back Pain Having Children With Cerebral Palsy: A Randomized Controlled Trial.","OBJECTIVE
Many mothers of children with cerebral palsy experience low back pain, so the purpose of this study was to investigate the effect of stabilization exercises along with self-care training on transverse abdominal muscle activity, pain, disability, and depression in them.
DESIGN
In this single-blinded randomized clinical trial, 32 mothers with cerebral palsy children were selected were randomly divided into two groups. Both groups received self-care training individually. For the experimental group, in addition to the self-care training, 24 sessions of stabilization exercises were held. Outcome measures included visual analog scale, Roland-Morris Disability Questionnaire, Persian version of Beck Depression Inventory-II, and ultrasonography.
RESULTS
In the experimental group, the transverse abdominal muscle activity during abdominal hollowing exercises was significantly increased (P < 0.05). There was no significant difference between the two groups in pain, disability, and depression (P > 0.05).
CONCLUSIONS
Stabilization exercises could improve the voluntary activity of transverse abdominal muscle of mothers of children with cerebral palsy.",2020,In the experimental group the transverse abdominal muscle activity during abdominal hollowing exercises were significantly increased (p <0.05).,"['mothers with low back pain having children with CP', 'mothers of children with cerebral palsy', '32 mothers with CP children', 'mothers of children with cerebral palsy (CP) experience low back pain (LBP']","['stabilization exercises along with self-care training', 'Stabilization exercises']","['transverse abdominal muscle activity', 'transverse abdominal muscle activity, pain, disability and depression', 'transverse abdominal activity, pain, and disability', 'voluntary activity of transverse abdominal muscle', 'pain, disability and depression', 'Visual Analog Scale, Roland-Morris Disability Questionnaire, Persian version of Beck Depression Inventory-II and ultrasonography']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0224378', 'cui_str': 'Transverse Abdominal'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]",32.0,0.033386,In the experimental group the transverse abdominal muscle activity during abdominal hollowing exercises were significantly increased (p <0.05).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Ahmadizadeh', 'Affiliation': 'From the Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran (ZA, FE); Department of Occupational Therapy, School of Rehabilitation Science, Iran University of Medical Sciences, Tehran, Iran (ZA); Neuromuscular Rehabilitation Research Center, Department of Neurology, School of Medicine, Semnan University of Medical Sciences, Semnan, Iran (SAS); and Social Determinant of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran (MM).'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': ''}, {'ForeName': 'Syed Afshin', 'Initials': 'SA', 'LastName': 'Samaei', 'Affiliation': ''}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mirmohammadkhani', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001315']
770,31906607,Incidence of newly developed postoperative low back pain with median versus paramedian approach for spinal anesthesia.,"Background
The effects of anesthetic techniques on postdural puncture backache (PDPB) have not been specifically evaluated. The purpose of this study was to compare the incidence and severity of PDPB between median and paramedian techniques.
Methods
Patients were randomized to receive spinal anesthesia by either a median (Group M, n = 50) or paramedian (Group P, n = 50) approach. We recorded each patient's personal number of puncture attempts, surgical position, and operation duration. We investigated the incidence and intensity of back pain 1 day, 1 week, and 1, 2, and 3 months postoperatively.
Results
The overall incidence of PDPB was higher in the Group M (18/50, 36%) than in the Group P (8/50, 16%) (P = 0.023). Twenty-four hours after surgery, 8 patients in Group M and 6 patients in Group P complained of back pain. Seven days after the surgery, 16 patients in the Group M and 5 patients in the Group P complained of pain (P = 0.007). After 1 month, 5 patients in the Group M and 1 patient in the Group P complained of pain. Only one patient in each group complained of pain after 3 months. No significant differences were noted in NRSs between the groups during study period.
Conclusions
The results of this study suggest that spinal anesthesia using the paramedian approach reduces the incidence of PDPB during the early postoperative period.",2020,"The overall incidence of PDPB was higher in the M group (16/50, 32%) than in the P group (8/50, 16%).","['postdural puncture backache (PDPB', 'spinal anesthesia']","['anesthetic technique', 'spinal anesthesia by either a median (M group, n = 50) or paramedian (P group, n = 50) approach']","['NRS score', 'incidence and intensity of back pain', 'personal number of puncture attempts, surgical position, and operation duration', 'overall incidence of PDPB', 'incidence of PDPB', 'average numeric rating scale (NRS) pain scores', 'report pain', 'pain', 'NRS scores', 'back pain']","[{'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0222045'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0844443,"The overall incidence of PDPB was higher in the M group (16/50, 32%) than in the P group (8/50, 16%).","[{'ForeName': 'Jung Ha', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gwangju Christian Hospital, Gwangju, Korea.'}, {'ForeName': 'Dae Hun', 'Initials': 'DH', 'LastName': 'Yoon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gwangju Christian Hospital, Gwangju, Korea.'}, {'ForeName': 'Bong Ha', 'Initials': 'BH', 'LastName': 'Heo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gwangju Christian Hospital, Gwangju, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.19409']
771,31584525,Successful Treatment of Multiple Common Warts With Intralesional Ozone.,"BACKGROUND
Although there are multiple treatments for warts, wart management remains a challenge. Ozone therapy is an emerging treatment for infectious and noninfectious dermatological diseases.
OBJECTIVE
To assess intralesional ozone gas safety and efficacy in multiple warts management.
MATERIALS AND METHODS
Seventy-four adult patients with multiple common warts were included in this study. They were randomly assigned into 2 groups: first group comprised 44 patients treated with intralesional ozone gas, and the second group comprised 30 patients who received intralesional saline injection. In both groups, warts in all patients were directly injected weekly until complete clearance occurred or for a maximum of 10 treatment sessions. The subjects were followed for 6 months to record any recurrences.
RESULTS
In the ozone group, 25 patients (56.8%) had a complete response with an excellent cosmetic outcome, 15 patients (34.1%) showed a partial response, and 4 patients (9.1%) had no response. More subjects responded to ozone than to saline (p < .001). Ozone therapy was associated with mild side effects, including pain at time of injection, numbness, and fatigue.
CONCLUSION
Intralesional ozone is effective and safe for the treatment of multiple warts.",2020,More subjects responded to ozone than to saline (p < .001).,['Seventy-four adult patients with multiple common warts were included in this study'],"['intralesional ozone gas', 'Intralesional Ozone', 'intralesional saline injection', 'Ozone therapy']","['complete response with an excellent cosmetic outcome', 'mild side effects, including pain at time of injection, numbness, and fatigue', 'partial response']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0043037', 'cui_str': 'Verruca vulgaris (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",74.0,0.0479414,More subjects responded to ozone than to saline (p < .001).,"[{'ForeName': 'Alshimaa M', 'Initials': 'AM', 'LastName': 'Ibrahim', 'Affiliation': '*All authors are affiliated with the Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Reham A', 'Initials': 'RA', 'LastName': 'Elkot', 'Affiliation': ''}, {'ForeName': 'Shrook A', 'Initials': 'SA', 'LastName': 'Khashaba', 'Affiliation': 'All authors are affiliated with the Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002174']
772,28253845,Impact of a combined multimodal-aerobic and multimodal intervention compared to standard aerobic treatment in breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design.,"BACKGROUND
Cancer-related fatigue (CRF) and insomnia are major complaints in breast cancer survivors (BC). Aerobic training (AT), the standard therapy for CRF in BC, shows only minor to moderate treatment effects. Other evidence-based treatments include cognitive behavioral therapy, e.g., sleep education/restriction (SE) and mindfulness-based therapies. We investigated the effectiveness of a 10-week multimodal program (MT) consisting of SE, psycho-education, eurythmy- and painting-therapy, administered separately or in combination with AT (CT) and compared both arms to AT alone.
METHODS
In a pragmatic comprehensive cohort study BC with chronic CRF were allocated randomly or by patient preference to (a) MT, (b) CT (MT + AT) or (c) AT alone. Primary endpoint was a composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale after 10 weeks of intervention (T1); a second endpoint was a follow-up assessment 6 months later (T2). The primary hypothesis stated superiority of CT and non-inferiority of MT vs. AT at T1. A closed testing procedure preserved the global α-level. The intention-to-treat analysis included propensity scores for the mode of allocation and for the preferred treatment, respectively.
RESULTS
Altogether 126 BC were recruited: 65 were randomized and 61 allocated by preference; 105 started the intervention. Socio-demographic parameters were generally balanced at baseline. Non-inferiority of MT to AT at T1 was confirmed (p < 0.05), yet the confirmative analysis stopped as it was not possible to confirm superiority of CT vs. AT (p = 0.119). In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 (MT) or T2 alone (CT), respectively.
CONCLUSIONS
The multimodal CRF-therapy was found to be confirmatively non-inferior to standard therapy and even yielded exploratively sustained superiority. A randomized controlled trial including a larger sample size and a longer follow-up to evaluate multimodal CRF-therapy is highly warranted.
TRIAL REGISTER
DRKS-ID: DRKS00003736 . Recruitment period June 2011 to March 2013. Date of registering 19 June 2012.",2017,"In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 (MT) or T2 alone (CT), respectively.
","['breast cancer survivors (BC', 'pragmatic comprehensive cohort study BC with chronic CRF', 'breast cancer survivors with chronic cancer-related fatigue - results of a three-armed pragmatic trial in a comprehensive cohort design', 'Altogether 126 BC were recruited: 65']","['patient preference to (a) MT, (b) CT (MT\u2009+\u2009AT) or (c) AT alone', 'MT', 'multimodal program (MT) consisting of SE, psycho-education, eurythmy- and painting-therapy, administered separately or in combination with AT (CT', 'multimodal CRF-therapy', 'Aerobic training (AT', 'combined multimodal-aerobic and multimodal intervention', 'standard aerobic treatment']","['cognitive behavioral therapy, e.g., sleep education/restriction (SE) and mindfulness-based therapies', 'composite score of the Pittsburgh Sleep Quality Index and the Cancer Fatigue Scale', 'Socio-demographic parameters']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C4274302', 'cui_str': 'Fatigue associated with malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3658215', 'cui_str': 'Naturalistic Randomized Clinical Trial'}]","[{'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0222045'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",126.0,0.100767,"In consecutive exploratory analyses MT and CT were superior to AT at T1 and T2 (MT) or T2 alone (CT), respectively.
","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kröz', 'Affiliation': 'Department of Internal Medicine, Havelhöhe Hospital, Kladower Damm 221, D-14089, Berlin, Germany. mkroez@havelhoehe.de.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Reif', 'Affiliation': 'Society for Clinical Research, Hardenbergstraße 20, Berlin, 10623, Germany.'}, {'ForeName': 'Augustina', 'Initials': 'A', 'LastName': 'Glinz', 'Affiliation': 'Research Institute Havelhöhe, Kladower Damm 221, Berlin, D-14089, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Berger', 'Affiliation': 'Institute for Integrative Medicine, University of Witten/Herdecke, Gerhard-Kienle-Weg 4, Herdecke, 58313, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Nikolaou', 'Affiliation': 'Clinic for Rehabilitative Medicine, Hannover Medical School, Carl-Neuberg-Straße 1, Hannover, 30625, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zerm', 'Affiliation': 'Department of Internal Medicine, Havelhöhe Hospital, Kladower Damm 221, D-14089, Berlin, Germany.'}, {'ForeName': 'Benno', 'Initials': 'B', 'LastName': 'Brinkhaus', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité Universitätsmedizin Berlin, Charité CCM, Berlin, 10098 Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Girke', 'Affiliation': 'Department of Internal Medicine, Havelhöhe Hospital, Kladower Damm 221, D-14089, Berlin, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Büssing', 'Affiliation': 'Institute for Integrative Medicine, University of Witten/Herdecke, Gerhard-Kienle-Weg 4, Herdecke, 58313, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Gutenbrunner', 'Affiliation': 'Clinic for Rehabilitative Medicine, Hannover Medical School, Carl-Neuberg-Straße 1, Hannover, 30625, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-017-3142-7']
773,31714033,"Motivated, Fit, and Strong-Using Counter-Stereotypical Images to Reduce Weight Stigma Internalisation in Women with Obesity.","BACKGROUND
This study aimed to use implicit retraining to change automatic associations between body size and physical activity (PA) in women with obesity to reduce weight bias internalisation (WBI).
METHODS
A Solomon-square experimental design was used to determine the effect of a four-week online implicit retraining intervention on WBI (primary measure) and PA attitudes, self-efficacy, and self-reported behaviour (secondary measures). The intervention was a visual probe task pairing counter-stereotypical images of active individuals with obesity with positive PA-related words. In qualitative telephone interviews, a sub-sample of participants provided feedback and recommendations for using counter-stereotypical images in PA promotion.
RESULTS
Women completed the intervention (n = 48) or a control task (n = 55). Results of a RM-ANOVA showed no interaction or main effect of group on WBI. A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up. There were no differences between groups or over time for PA attitudes, self-efficacy, or behaviour. Women who completed interviews (n = 16) discussed several benefits and drawbacks of using counter-stereotypical images.
CONCLUSION
Implicit retraining did not reduce WBI but qualitative findings support the use of counter-stereotypical PA images.",2020,"A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up.","['active individuals with obesity with positive PA-related words', 'women with obesity to reduce weight bias internalisation (WBI', 'Women with Obesity']","['Implicit retraining', 'online implicit retraining intervention', 'implicit retraining']","['time for PA attitudes, self-efficacy, or behaviour', 'WBI (primary measure) and PA attitudes, self-efficacy, and self-reported behaviour (secondary measures']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.0307913,"A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up.","[{'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Myre', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Berry', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Geoff D C', 'Initials': 'GDC', 'LastName': 'Ball', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Hussey', 'Affiliation': 'Obesity Canada, Edmonton, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12187']
774,32412858,Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial.,"Background: This analysis from the SMILE randomized study was performed to identify predictive factors associated with the greatest reductions in hypoglycemia with the Medtronic MiniMed™ 640G Suspend before low feature in adults with type 1 diabetes at high risk of severe hypoglycemia. Methods: Clinical and treatment-related factors associated with decreased sensor hypoglycemia (SH) were identified in participants from the intervention arm by univariate and multivariate analyses. Results: The reduction in SH events <54 mg/dL (<3.0 mmol/L) in the intervention group was significantly ( P < 0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54 mg/dL. When excluding continuous glucose monitoring (CGM) factors not readily available (MNSHE, duration of SH events, area under the curve, mean amplitude of glycemic excursions), only the baseline mean time spent <54 mg/dL was found to be a significant independent predictor factor ( P < 0.0001). Baseline HbA1 c , mean self-monitoring of blood glucose (SMBG), and coefficient of variation of SMBG were significant, although weak, predictors in the absence of any CGM data. Conclusions: The greatest reductions in SH events achieved with the MiniMed 640G system with the Suspend before low feature were seen in participants with higher baseline MNSHE. Measuring these (usually uncollected) events can be a useful tool to predict hypoglycemia reduction. ClinicalTrials.gov Registration Identifier NCT02733991.",2020,"The reduction in SH events <54mg/dL (<3.0 mmol/L) in the intervention group was significantly (p<0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001).","['adults with type 1 diabetes at high risk of severe hypoglycemia', 'patients at high risk of severe hypoglycemia']",['automated predictive insulin suspension'],"['CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE', 'sensor hypoglycemia (SH', 'sensor hypoglycemic events (MNSHE', 'reduction in SH events', 'Baseline HbA1c, mean self-monitoring of blood glucose (SMBG) and coefficient of variation (CV) of SMBG', 'SH events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]",,0.0353609,"The reduction in SH events <54mg/dL (<3.0 mmol/L) in the intervention group was significantly (p<0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54mg/dL. When excluding CGM factors not readily available (MNSHE, duration of SH events, area under the curve [AUC], mean amplitude of glycemic excursions [MAGE]), only the baseline mean time spent <54mg/dL was found to be a significant independent predictor factor (p0.0001).","[{'ForeName': 'Aklilu', 'Initials': 'A', 'LastName': 'Habteab', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Castañeda', 'Affiliation': 'Medtronic Bakken Research Center, Maastricht, The Netherlands.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'de Valk', 'Affiliation': 'Department of Internal Medicine, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""Department of Internal Medicine King's College Hospital, Diabetes Research Group, London, United Kingdom.""}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Bosi', 'Affiliation': 'Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University, Milano, Italy.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Lablanche', 'Affiliation': ""Department of Diabetology, Grenoble University Hospital, Service d'Endocrinologie, Grenoble, France.""}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'de Portu', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Da Silva', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Vorrink-de Groot', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Medtronic, Northridge, California, USA.'}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Cohen', 'Affiliation': 'Medtronic International Trading Sàrl, Tolochenaz, Switzerland.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0495']
775,31567609,"1550-nm Nonablative Fractional Laser Versus 10,600-nm Ablative Fractional Laser in the Treatment of Surgical and Traumatic Scars: A Comparison Study on Efficacy and Treatment Regimen.","BACKGROUND
The appearance and symptoms of scars can cause significant distress to patients.
OBJECTIVE
To assess and compare efficacy of the 1,500-nm nonablative fractional laser (NAFL) and 10,600-nm ablative fractional laser (AFL) in reducing symptoms and improving the appearance of traumatic or surgical scars.
MATERIALS AND METHODS
Single-center prospective, randomized, blinded, split-scar study was conducted on 100 patients with a scar obtained through trauma or surgery. Three treatments of NAFL or AFL were administered to each half of the scar at 4-week intervals. Scars were self-rated by the patient using the Patient and Observer Scar Assessment Scale and a satisfaction score and objectively evaluated by blinded dermatologists using the Manchester Scar Scale and visual analog scale.
RESULTS
Blinded observers found no statistically significant difference in scar appearance. Patient rating showed improvement of scar appearance (p < .0001). Pain was worse after treatment with AFL (p = .0492). Overall, there was no statistically significant evidence of one laser being superior or inferior to the other for patient and blinded observer scores (p = .3173 and p = .2513, respectively).
CONCLUSION
Scar treatment with AFL or NAFL is associated with high patient satisfaction. Objective evaluation of scars did not identify improvement in scar appearance.",2020,"Overall, there was no statistically significant evidence of one laser being superior or inferior to the other for patient and blinded observer scores (p = .3173 and p = .2513, respectively).
","['Surgical and Traumatic Scars', '100 patients with a scar obtained through trauma or surgery']","['NAFL or AFL', '1,500-nm nonablative fractional laser (NAFL) and 10,600-nm ablative fractional laser (AFL', 'AFL or NAFL', 'AFL', '1550-nm Nonablative Fractional Laser Versus 10,600-nm Ablative Fractional Laser']","['scar appearance', 'Pain', 'Observer Scar Assessment Scale and a satisfaction score and objectively evaluated by blinded dermatologists using the Manchester Scar Scale and visual analog scale']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0036282', 'cui_str': 'Traumatic scar'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",100.0,0.0435432,"Overall, there was no statistically significant evidence of one laser being superior or inferior to the other for patient and blinded observer scores (p = .3173 and p = .2513, respectively).
","[{'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Chitgopeker', 'Affiliation': 'Medical Dermatology Associates of Chicago, Chicago, Illinois.'}, {'ForeName': 'Lainee', 'Initials': 'L', 'LastName': 'Goettsche', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Landherr', 'Affiliation': 'Forefront Dermatology, Cedar Rapids, Iowa.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ye', 'Affiliation': 'Loyola Stritch School of Medicine, Maywood, Illinois.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Johnson-Jahangir', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}, {'ForeName': 'Nkanyezi', 'Initials': 'N', 'LastName': 'Ferguson', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'VanBeek', 'Affiliation': 'University of Iowa Hospitals and Clinics, Department of Dermatology, Iowa City, Iowa.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002152']
776,31574029,"A Randomized, Controlled Pilot Trial Comparing Platelet-Rich Plasma to Topical Minoxidil Foam for Treatment of Androgenic Alopecia in Women.","BACKGROUND
Androgenic alopecia (AGA) is a common hair loss disorder. Studies have demonstrated successful treatment with platelet-rich plasma (PRP) in men, but studies in women are few.
OBJECTIVE
To evaluate PRP in the treatment of AGA in women, compared with topical minoxidil.
MATERIALS AND METHODS
Twenty women with AGA received topical minoxidil for 12 weeks and injectable PRP for 12 weeks in a randomized crossover design with an 8-week washout between treatments. Standardized TrichoScan analysis and quality-of-life questionnaires were assessed at baseline and 12-week follow-up for each treatment.
RESULTS
After PRP, significant increases from baseline to Week 12 in TrichoScan analysis hair count (p = .002) and vellus hair density (p = .009) occurred. However, minoxidil resulted in significant increases in hair count (p < .001), vellus hair density (p = .03), terminal hair density (p = .004), and cumulative thickness (p = .004). Several quality of life responses improved from baseline to Week 12 after PRP treatment, whereas no improvements were noted after minoxidil.
CONCLUSION
Platelet-rich plasma is an effective treatment for hair regrowth in female AGA, although not as effective as minoxidil. However, the improved quality of life responses after PRP, but not minoxidil, suggest a potential overall greater degree of satisfaction with PRP.
LEVELS OF EVIDENCE
I.
CLINICAL TRIAL REGISTRATION
NCT03488108.",2020,"After PRP, significant increases from baseline to Week 12 in TrichoScan analysis hair count (p = .002) and vellus hair density (p = .009) occurred.","['Twenty women with AGA received', 'Androgenic Alopecia in Women']","['topical minoxidil', 'minoxidil', 'Platelet-Rich Plasma to Topical Minoxidil Foam', 'injectable PRP']","['vellus hair density', 'quality of life responses', 'hair count', 'terminal hair density', 'cumulative thickness', 'Standardized TrichoScan analysis and quality-of-life questionnaires', 'Several quality of life responses']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}]","[{'cui': 'C0221959', 'cui_str': 'Structure of vellus hair'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0034380'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0221960', 'cui_str': 'Structure of terminal hair'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",20.0,0.0624348,"After PRP, significant increases from baseline to Week 12 in TrichoScan analysis hair count (p = .002) and vellus hair density (p = .009) occurred.","[{'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Bruce', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Thais P', 'Initials': 'TP', 'LastName': 'Pincelli', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Heckman', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Cheryl M', 'Initials': 'CM', 'LastName': 'Desmond', 'Affiliation': 'Center for Regenerative Medicine, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Arthurs', 'Affiliation': 'Center for Regenerative Medicine, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Nancy N', 'Initials': 'NN', 'LastName': 'Diehl', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Erika J', 'Initials': 'EJ', 'LastName': 'Douglass', 'Affiliation': 'Departments of Cardiovascular Medicine.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Bruce', 'Affiliation': 'Departments of Cardiovascular Medicine.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Shapiro', 'Affiliation': 'Orthopedic Surgery, Mayo Clinic, Jacksonville, Florida.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002168']
777,31567611,Pooled Subject-Reported Outcomes From 2 Phase 3 Studies of OnabotulinumtoxinA for Simultaneous Treatment of Forehead and Glabellar Lines.,"BACKGROUND
Understanding the subjects' perspective is critical for successfully treating upper facial lines.
OBJECTIVE
To understand subjects' self-perception and overall satisfaction after onabotulinumtoxinA treatment for forehead and glabellar lines.
METHODS
This analysis pooled data from two 12-month, pivotal phase 3 studies in which toxin-naive subjects received onabotulinumtoxinA 40 U or placebo for treatment of upper facial lines. OnabotulinumtoxinA was administered as 0.1-mL injections at 10 prespecified sites (frontalis: 20 U; glabellar complex: 20 U). Each study used 3 reliable and validated patient-reported outcome instruments to evaluate subject satisfaction and appearance-related psychological effects: the Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire. In total, data for 865 subjects (608, onabotulinumtoxinA 40 U; 257, placebo) were analyzed.
RESULTS
Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo. SPA results demonstrated that a significant proportion of subjects in the pooled analysis felt they looked younger after treatment than at baseline (all, p < .0001 vs placebo).
CONCLUSION
This study demonstrates a high level of treatment satisfaction and significantly improved appearance-related psychological outcomes among toxin-naive subjects after onabotulinumtoxinA 40 U treatment.",2020,"RESULTS
Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo.","['toxin-naive subjects after onabotulinumtoxinA 40 U treatment', '865 subjects (608, onabotulinumtoxinA 40 U; 257']","['placebo', 'onabotulinumtoxinA 40 U or placebo', 'OnabotulinumtoxinA']","['appearance-related psychological outcomes', 'Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire']","[{'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",865.0,0.14096,"RESULTS
Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ogilvie', 'Affiliation': 'Skin Concept, Munich, Germany.'}, {'ForeName': 'Alexander Z', 'Initials': 'AZ', 'LastName': 'Rivkin', 'Affiliation': 'David Geffen School of Medicine, UCLA, Los Angeles, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dayan', 'Affiliation': 'DeNova Research, Chicago, Illinois.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Yoelin', 'Affiliation': 'Medical Associates Inc., Newport Beach, California.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Larsen', 'Affiliation': 'Peloton Advantage, Parsippany, New Jersey.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Varon', 'Affiliation': 'Health Economics and Outcomes Research, Allergan plc, Irvine, California.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Garcia', 'Affiliation': 'Health Economics and Outcomes Research, Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002153']
778,32413296,Writing to the Mind's Eye of the Blind.,"The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight. In this issue of Cell, Beauchamp et al. use electrical stimulation of the visual cortex to create visual perception of shapes.",2020,The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight.,[],[],[],[],[],[],,0.0240986,The implantation of electrodes on the visual cortex of blind individuals could lead to the restoration of a rudimentary form of sight.,"[{'ForeName': 'Pieter R', 'Initials': 'PR', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Vision & Cognition, Netherlands Institute for Neuroscience, Meibergdreef 47, 1105 BA Amsterdam, Netherlands; Department of Integrative Neurophysiology, VU University, De Boelelaan 1085, 1081 HV Amsterdam, Netherlands; Department of Psychiatry, Academic Medical Center, Postbus 22660, 1100 DD Amsterdam, Netherlands. Electronic address: p.roelfsema@nin.knaw.nl.'}]",Cell,['10.1016/j.cell.2020.03.014']
779,32106642,Nebulized heparin and salbutamol versus salbutamol alone in acute exacerbations of chronic obstructive pulmonary disease requiring mechanical ventilation: a double-blind randomized controlled trial.,"Background
Nebulized heparin has been effectively used in the management of many pulmonary diseases. However, its effect on mechanically ventilated patients with acute exacerbation chronic obstructive pulmonary disease (AECOPD) has never been studied. This study aimed to assess the efficacy of nebulized heparin and salbutamol to increase ventilator-free days (VFD) in mechanically ventilated AECOPD patients and the effect of nebulized heparin on respiratory and coagulation functions.
Methods
In this double-blind controlled study, 60 mechanically ventilated adult patients with AECOPD were randomly allocated into two groups; heparin and salbutamol (HS) group and salbutamol only (S) group. In the HS group, patients received nebulized heparin (25,000 IU) and salbutamol (5 mg) every 6 hours. Patients in the S group received nebulized salbutamol only (5 mg). The treatment was continued while patients remained ventilated for a maximum of 14 days. The primary outcome was VFDs at day 14. PaCO2, PaO2/FiO2 ratio, number of nebulizations withheld, C-reactive protein (CRP) titer and activated partial thromboplastin time (APTT) were secondary outcomes.
Results
Patients in the Group HS had significantly more VFDs 4.7 ± 3.3 compared with those in the Group S 2.4 ± 2.6, P = 0.007. PaCO2 levels, PaO2/FiO2, the decrease in the CRP level and the increase in the APTT from the baseline showed no evidence of difference in both groups.
Conclusions
The co-administration of nebulized heparin and salbutamol, compared with salbutamol alone, significantly increased (VFDs) among mechanically ventilated AECOPD patients without increasing bleeding risks.",2020,"Both groups were comparable as regards all other variables.
","['sixty adults mechanically ventilated patients with AECOPD', 'mechanically ventilated patients with acute exacerbation chronic obstructive pulmonary disease (AECOPD', 'acute exacerbation of chronic obstructive pulmonary disease requiring mechanical ventilation']","['Salbutamol alone', 'Nebulized heparin and salbutamol', 'heparin', 'nebulised heparin and salbutamol', 'salbutamol', 'nebulised heparin', 'nebulised salbutamol']","['VFDs', 'bleeding hazards', 'duration of ventilator-free days', 'PaCO2, PaO2/FiO2 ratio, the number of nebulisation cessions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1822073', 'cui_str': 'PaO2'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",60.0,0.462575,"Both groups were comparable as regards all other variables.
","[{'ForeName': 'Tarek Mohamed', 'Initials': 'TM', 'LastName': 'Ashoor', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Ahmad Mahmoud', 'Initials': 'AM', 'LastName': 'Hasseb', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Ibrahim Mamdouh', 'Initials': 'IM', 'LastName': 'Esmat', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Ain-Shams University, Cairo, Egypt.'}]",Korean journal of anesthesiology,['10.4097/kja.19418']
780,31476615,Teachers' nonverbal behaviors influence children's stereotypic beliefs.,"The current research tested whether differences in teachers' nonverbal behaviors influence children's intergroup attitudes and stereotypic beliefs. In this study, 5- to 8-year-old participants (N = 96) were assigned to novel groups (marked by T-shirt color) and then viewed interactions between teachers and pairs of students who were also members of the novel groups. Across four interactions, the teacher directed positive nonverbal behaviors toward students from one group and directed negative nonverbal behaviors toward students from another group. After viewing the interactions, participants were presented with pairs of new students from the two novel groups and were asked three types of test questions. When participants were asked who was smarter, they selected new students from the group that had received positive nonverbal behaviors regardless of their own group membership. However, when asked who they would like to befriend, only participants who were assigned to the group that received positive behaviors selected ingroup members. On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance. This study shows that teachers' nonverbal behaviors may be one source of children's academic stereotypes, including negative stereotypes about groups to which they belong. Moreover, these findings highlight the importance of subtle social cues in guiding children's beliefs about social groups.",2019,"On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance.","['participants were asked who was smarter, they selected new students from the group that had received positive nonverbal behaviors regardless of their own group membership', '5- to 8-year-old participants (N\u202f=\u202f96']",[],"[""Teachers' nonverbal behaviors influence children's stereotypic beliefs""]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",4.0,0.0412505,"On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brey', 'Affiliation': ""Department of Psychology, University of Hawai'i at Manoa, Honolulu, HI 96822, USA. Electronic address: elbrey@hawaii.edu.""}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pauker', 'Affiliation': ""Department of Psychology, University of Hawai'i at Manoa, Honolulu, HI 96822, USA.""}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104671']
781,32413238,Pharmacokinetics and Bioequivalence of 2 Olanzapine Orally Disintegrating Tablet Products in Healthy Chinese Subjects Under Fed and Fasting Conditions.,"To assess the bioequivalence of two 5-mg olanzapine orally disintegrating tablet (ODT) products, 2 randomized, open-label, single-dose, 2-way crossover studies were carried out under fasting or fed conditions. Blood samples were collected at scheduled times according to the study protocol. Statistical analysis of area under the concentration-time curve from time 0 to 168 hours (AUC 0-t ), area under the curve from time zero to infinity (AUC 0-∞ ), and peak plasma concentration (C max ) was conducted. Two formulations were considered bioequivalent if the 90% confidence intervals (CIs) of the geometric mean ratios for AUC 0-t, AUC 0-∞ , and C max were within the range of 0.80-1.25. Adverse events were recorded and evaluated throughout the studies. A total of 48 subjects with 24 in each study completed the 2 studies. In fasted subjects, the 90%CIs for the test product versus the reference product were 97.28%-105.13% for AUC 0-t , 97.57%-105.54% for AUC 0-∞ , and 90.94%-103.97% for C max . In fed subjects, the 90%CIs for AUC 0-t , AUC 0-∞ and C max were 99.73%-122.63%, 99.56%-121.75%, and 99.46%-120.46%, respectively. No serious adverse events were reported in the studies. The reference and the test product of 5-mg olanzapine ODT show comparable pharmacokinetic profiles under both fed and fasted conditions and were considered bioequivalent.",2020,No serious adverse events were reported in the studies.,"['48 subjects with 24 in each study completed the 2 studies', 'Healthy Chinese Subjects Under Fed and Fasting Conditions']","['olanzapine', 'Olanzapine Orally Disintegrating Tablet Products', 'olanzapine ODT']","['serious adverse events', 'peak plasma concentration', '90%CIs for AUC 0-t , AUC 0-∞ and C max', 'Adverse events']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1248714', 'cui_str': 'olanzapine Disintegrating Oral Tablet'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",48.0,0.0358422,No serious adverse events were reported in the studies.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'QILU Pharmaceutical, Jinan, Shandong, China.'}, {'ForeName': 'Hongquan', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Junlin', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yunfang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Jianghui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Pharmacology Lab, Nanjing First Hospital, Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.765']
782,31569307,The Effects of Goal Framing on Energy Drink Consumption: The Moderating Role of Temporal Framing.,"BACKGROUND
With the rapid expansion of the energy drink market, concerns associated with its adverse effects have been raised. This research examines how goal framing moderated by temporal framing affects attitude, subjective norm, and perceived behavioral control related to energy drink consumption.
METHODS
A 2 (goal framing: gain vs. loss) × 2 (temporal framing: present-oriented vs. future-oriented) randomised experiment was employed. The sample consisted of 195 college students who consume energy drinks.
RESULTS
Results showed that a future-oriented message was more effective than a present-oriented one when used in gain framing in increasing perceived behavioral control, as predicted. A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result.
CONCLUSIONS
The findings extend previous research on goal framing by (1) identifying an important moderator-temporal framing-in processing health promotion messages about energy drink consumption and (2) examining such moderated effects on different psychological factors. The findings of this study are expected to inform the development of more effective message strategies in health domains.",2020,"A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result.
",['195 college students who consume energy drinks'],[],['Energy Drink Consumption'],"[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}]",[],"[{'cui': 'C3179078', 'cui_str': 'Energy Drinks'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0554904,"A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result.
","[{'ForeName': 'Jarim', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Yonsei University, Seoul, Republic of Korea.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12184']
783,31576791,"Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies.","OBJECTIVE
Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar depression with or without concurrent manic symptoms.
METHODS
Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. Efficacy was assessed in cariprazine 1.5 and 3 mg/day dose groups versus placebo; analyses included the least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
RESULTS
Of 1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms. For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of -2.5 (p = .0033) and -2.9 (p = .0010), respectively; for patients without manic symptoms, the LSMD was significant for 1.5 mg/day (-3.3; p = .0008), but not for 3 mg/day (-1.9; p = .0562).
CONCLUSION
The results of this post hoc analysis suggest that cariprazine may be an appropriate treatment option for patients with bipolar I depression with or without manic symptoms, with higher doses potentially more effective in patients with manic symptoms.",2020,"For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of -2.5 (p = .0033) and -2.9 (","['patients with bipolar I depression with or without manic symptoms', '1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms', 'bipolar I depression with and without concurrent manic symptoms', 'controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4']","['placebo', 'cariprazine']","['Montgomery-Åsberg Depression Rating Scale (MADRS) total score', 'Cariprazine efficacy', 'Efficacy', 'MADRS total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]",1383.0,0.224252,"For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of -2.5 (p = .0033) and -2.9 (","[{'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Earley', 'Affiliation': 'Clinical Development, Allergan, Madison, New Jersey, USA.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Medical Affairs, Allergan, Madison, New Jersey, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Stahl', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, California, USA.'}]",CNS spectrums,['10.1017/S1092852919001287']
784,28323342,Inflammatory Markers and Frailty in Long-Term Care Residents.,"OBJECTIVES
To determine whether proinflammatory biomarkers are associated with frailty assessed according to functional status, mobility, mental health, and falls over 24 months.
DESIGN
Secondary analysis of a 2-year double-blind clinical trial for osteoporosis.
SETTING
Nursing homes and assisted living facilities.
PARTICIPANTS
Women aged 65 and older with osteoporosis in long-term care (LTC) (N = 178).
MEASUREMENTS
Baseline serum concentrations of proinflammatory cytokines and soluble receptors (high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNFα) and its two receptors (TNFα-R1 and TNFα-R2), interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R), IL-10), functional status assessed according to activities of daily living, the Nursing Home Physical Performance Test, gait speed, cognitive status, mental health, and falls.
RESULTS
At baseline, older age was moderately associated with higher serum concentrations of hs-CRP (correlation coefficient (r) = 0.22), TNFα-R1 (r = 0.36), TNFα-R2 (r = 0.34), and IL-10 (r = 0.16) (all P < .05). Frail participants had significantly higher hs-CRP, TNFα-R1, TNFα-R2, IL-6, and IL-6-sR levels (all P < .05) than those nonfrail participants. Higher baseline hs-CRP and IL-6 levels were associated with worse physical performance and gait speed at 12 months independent of age, zoledronic acid use, and comorbidity (|r| = 0.25-0.30; all P < .05). Inflammatory markers were not significantly associated with incident falls.
CONCLUSIONS
Higher proinflammatory biomarker levels are associated with frailty and poorer function and mobility in older women residing in LTC facilities.",2017,"Frail participants had significantly higher hs-CRP, TNFα-R1, TNFα-R2, IL-6, and IL-6-sR levels (all P < .05) than those nonfrail participants.","['older women residing in LTC facilities', 'Women aged 65 and older with osteoporosis in long-term care (LTC', 'Nursing homes and assisted living facilities']",[],"['higher hs-CRP, TNFα-R1, TNFα-R2, IL-6, and IL-6-sR levels', 'TNFα-R1', 'serum concentrations of hs-CRP', 'Baseline serum concentrations of proinflammatory cytokines and soluble receptors (high sensitivity C-reactive protein (hs-CRP), tumor necrosis factor alpha (TNFα) and its two receptors (TNFα-R1 and TNFα-R2), interleukin-6 (IL-6), soluble IL-6 receptor (sIL-6R', 'Inflammatory Markers and Frailty', 'IL-10), functional status assessed according to activities of daily living, the Nursing Home Physical Performance Test, gait speed, cognitive status, mental health, and falls', 'IL-10', 'Higher baseline hs-CRP and IL-6 levels', 'Inflammatory markers', 'TNFα-R2', 'physical performance and gait speed']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4521843', 'cui_str': 'CDR'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0023977'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0063717', 'cui_str': 'Receptors, IL-6'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C2607857'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0000921', 'cui_str': 'Falls'}]",178.0,0.175093,"Frail participants had significantly higher hs-CRP, TNFα-R1, TNFα-R2, IL-6, and IL-6-sR levels (all P < .05) than those nonfrail participants.","[{'ForeName': 'Gabrielle A', 'Initials': 'GA', 'LastName': 'Langmann', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Ferchak', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Neil M', 'Initials': 'NM', 'LastName': 'Resnick', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Greenspan', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.14876']
785,28193583,Nicotinic modulation of salience network connectivity and centrality in schizophrenia.,"Although functional abnormalities of the salience network are associated with schizophrenia, the acute effects of nicotine on its function and network dynamics during the resting state in patients are poorly understood. In this study, the effects of a 7 mg nicotine patch (vs. placebo) on salience network connectivity were examined in 17 patients with schizophrenia and 19 healthy subjects. We hypothesized abnormal connectivity between the salience network and other major networks (e.g. executive network) in patients under placebo administration and amelioration of this difference after nicotine. We also examined effects of nicotine on betweenness centrality (a measure of the influence of a region on information transfer throughout the brain) and local efficiency (a measure of local information transfer) of the network. A hybrid independent component analysis (ICA)/seed-based connectivity approach was implemented in which the salience network was extracted by ICA and cortical network peaks (anterior cingulate cortex (ACC), left and right insula) were used as seeds for whole-brain seed-to-voxel connectivity analysis. Significant drug X diagnosis interactions were observed between the ACC seed and superior parietal lobule and ventrolateral prefrontal cortex. A significant interaction effect was also observed between the left insula seed and middle cingulate cortex. During placebo conditions, abnormal connectivity predicted negative symptom severity and lower global functioning in patients. A significant drug X diagnosis interaction was also observed for betweenness centrality of the ACC. These results suggest that nicotine may target abnormalities in functional connectivity between salience and executive network areas in schizophrenia as well as affect the ability of the salience network to act as an integrator of global signaling in the disorder.",2017,Significant drug X diagnosis interactions were observed between the ACC seed and superior parietal lobule and ventrolateral prefrontal cortex.,"['patients under', 'schizophrenia', '17 patients with schizophrenia and 19 healthy subjects', 'patients']","['nicotine', 'nicotine patch (vs. placebo', 'placebo']","['left insula seed and middle cingulate cortex', 'salience network connectivity', 'Significant drug X diagnosis interactions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0598179', 'cui_str': 'Cingulate Cortex'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",19.0,0.0488611,Significant drug X diagnosis interactions were observed between the ACC seed and superior parietal lobule and ventrolateral prefrontal cortex.,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Smucny', 'Affiliation': 'Neuroscience Program, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. Electronic address: jason.smucny@ucdenver.edu.'}, {'ForeName': 'Korey P', 'Initials': 'KP', 'LastName': 'Wylie', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kronberg', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Kristina T', 'Initials': 'KT', 'LastName': 'Legget', 'Affiliation': 'Neuroscience Program, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; Research Service, Denver VA Medical Center, Denver, CO, USA; Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Tregellas', 'Affiliation': 'Neuroscience Program, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; Research Service, Denver VA Medical Center, Denver, CO, USA; Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2017.01.018']
786,31905097,"Effectiveness of Cervical Spine High-Velocity, Low-Amplitude Thrust Added to Behavioral Education, Soft Tissue Mobilization, and Exercise for People With Temporomandibular Disorder With Myalgia: A Randomized Clinical Trial.","OBJECTIVE
To determine the immediate and short-term effects of adding cervical spine high-velocity, low-amplitude thrust (HVLAT) to behavioral education, soft tissue mobilization, and a home exercise program on pain and dysfunction for people with a primary complaint of temporomandibular disorder (TMD) with myalgia.
DESIGN
Randomized clinical trial.
METHODS
Fifty individuals with TMD were randomly assigned to receive cervical HVLAT or sham manipulation for 4 visits over 4 weeks. Participants in both groups received other treatments, including standardized behavioral education, soft tissue mobilization, and a home exercise program. Primary outcomes included maximal mouth opening, the numeric pain-rating scale, the Jaw Functional Limitation Scale (JFLS), the Tampa Scale of Kinesiophobia for TMD (TSK-TMD), and a global rating of change (GROC). Self-report and objective measurements were taken at baseline, immediately after initial treatment, and follow-ups of 1 week and 4 weeks. A 2-by-4 mixed-model analysis of variance was used, with intervention group as the between-subjects factor and time as the within-subject factor. Separate analyses of variance were performed for dependent variables, and the hypothesis of interest was the group-by-time interaction.
RESULTS
There was no significant interaction for maximal mouth opening, the numeric pain-rating scale, or secondary measures. There were significant 2-way interactions for the JFLS ( d = 0.60) and TSK-TMD ( d = 0.80). The HVLAT group had lower fear at 4 weeks and improved jaw function earlier (1 week). The GROC favored the HVLAT group, with significant differences in successful outcomes noted immediately after baseline treatment (thrust, 6/25; sham, 0/25) and at 4 weeks (thrust, 17/25; sham, 10/25).
CONCLUSION
Both groups improved over time; however, differences between groups were small. There were significant differences between groups for the JFLS, TSK-TMD, and GROC. The additive clinical effect of cervical HVLAT to standard care remains unclear for treating TMD. J Orthop Sports Phys Ther 2020;50(8):455-465. Epub 6 Jan 2020. doi:10.2519/jospt.2020.9175 .",2020,Significant 2-way interactions were noted in JFLS (d=0.60) and TSK-TMD (d=0.80).,"['Individuals With Temporomandibular Disorder (TMD) With Myalgia', 'individuals with a primary complaint of temporomandibular disorder (TMD) with myalgia', 'Fifty individuals with TMD (n=50']","['cervical HVLAT or sham manipulation', 'Cervical Spine High Velocity Low Amplitude Thrust Added to Behavioral Education, Soft Tissue Mobilization, and Exercise', 'HVLAT', 'standardized behavioral education, soft tissue mobilization, and a HEP', 'cervical spine high velocity low amplitude thrust (HVLAT) added to behavioral education, soft tissue mobilization, and a home exercise program (HEP', 'JFLS']","['JFLS, TSK-TMD, and GROC', 'TSK-TMD), and Global Rating of Change (GROC', 'lower fear at 4-weeks and improved jaw function', 'pain and dysfunction', 'maximal mouth opening (MMO), Numeric Pain Rating Scale (NPRS), Jaw Functional Limitation Scale (JFLS), Tampa Scale of Kinesiophobia', 'successful outcomes', 'GROC']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",50.0,0.0853835,Significant 2-way interactions were noted in JFLS (d=0.60) and TSK-TMD (d=0.80).,"[{'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Reynolds', 'Affiliation': ''}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Puentedura', 'Affiliation': ''}, {'ForeName': 'Morey J', 'Initials': 'MJ', 'LastName': 'Kolber', 'Affiliation': ''}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9175']
787,32413174,Conservative vs Surgical Treatment of Impacted Femoral Neck Fracture in Patients 75 Years and Older.,"OBJECTIVE
To evaluate the safety and effectiveness of conservative treatment (CST), internal fixation (IF), and hemiarthroplasty (HA) in treating patients older than 75 years with impacted femoral neck fracture (IFNF).
DESIGN
A randomized clinical trial to compare clinical outcomes of CST, IF, and HA in IFNF patients older than 75 years with a 1:1:1 ratio.
SETTING
Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
PARTICIPANTS
A total of 154 patients with IFNF aged between 75 and 97 years.
INTERVENTION
Patients with IFNF were allocated to CST, IF, and HA. They all received a 36-month follow-up.
MEASUREMENTS
All patients were evaluated by Harris hip score (HHS) (primary outcome) for hip function, European Quality of Life-5 Dimensions (EQ-5D) index scores for health-related quality of life, and visual analogue scale score for hip pain. Operation duration, blood loss, mortality, union rate, complications, and reoperation were also recorded. Assessors were blind to the type of treatment.
RESULTS
The baseline parameters of the three groups were similar. IF group had much lower blood loss than HA group (P < .05), while no significant difference in operative duration was found between the two groups (P > .05). HHS in HA group was significantly higher at 1, 3, and 6 months (P < .05), but no significant difference in HHS was found between CST and IF groups at any of the time points during the overall follow-up (P > .05). EQ-5D index score was higher in HA group at each follow-up within 1 year (P < .05), but the difference was not significant at 2- and 3-year follow-up (P > .05). There was no significant difference in mortality among the three groups at each follow-up point (P > .05). The nonunion rate was 11.76% (6/51) in CST group and 9.80% (5/51) in IF group and showed no significant difference (P > .05).
CONCLUSION
CST may be a feasible way for IFNF in the older patients.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04219943. J Am Geriatr Soc 68:2214-2221, 2020.",2020,There was no significant difference in mortality among the three groups at each follow-up point (P > .05).,"['A total of 154 patients with IFNF aged between 75 and 97\u2009years', 'older patients', 'Nanjing First Hospital, Nanjing Medical University, Nanjing, China', 'Patients 75\u2009Years and Older', 'patients older than 75\u2009years with impacted femoral neck fracture (IFNF', 'IFNF patients older than 75\u2009years with a 1:1:1 ratio']","['conservative treatment (CST), internal fixation (IF), and hemiarthroplasty (HA', 'CST', 'Conservative vs Surgical Treatment of Impacted Femoral Neck Fracture']","['safety and effectiveness', 'HHS', 'Harris hip score (HHS) (primary outcome) for hip function, European Quality of Life-5 Dimensions (EQ-5D) index scores for health-related quality of life, and visual analogue scale score for hip pain', 'operative duration', 'EQ-5D index score', 'mortality', 'nonunion rate', 'Operation duration, blood loss, mortality, union rate, complications, and reoperation', 'blood loss']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",154.0,0.0456269,There was no significant difference in mortality among the three groups at each follow-up point (P > .05).,"[{'ForeName': 'Peiran', 'Initials': 'P', 'LastName': 'Wei', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Geng', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Qingqiang', 'Initials': 'Q', 'LastName': 'Yao', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16535']
788,27816035,Predictors of medication adherence and smoking cessation among smokers under community corrections supervision.,"INTRODUCTION
Individuals in the U.S. criminal justice system now represent over 12% of all current U.S. smokers. With smoking banned in most U.S. jails and prisons, the cessation focus for this population has shifted to individuals who are under community correction supervision (e.g., probation, parole). The aim of this study was to examine predictors of successful smoking cessation among criminal justice individuals supervised in the community.
METHODS
Five hundred participants under community corrections supervision were randomized to receive either four sessions of smoking cessation counseling or no counseling in conjunction with 12weeks of bupropion treatment plus brief physician advice to quit. Logistic regression analyses examined associations of smoking variables with medication adherence and successful abstinence. Mediation analysis evaluated the indirect effects of medication adherence on smoking abstinence.
RESULTS
The strongest associate of medication adherence was previous use of bupropion, while the strongest associate of smoking abstinence was medication adherence. Mediation analysis indicated that previous use of bupropion indirectly increased cessation rates through the pathway of increased medication adherence.
CONCLUSIONS
These results highlight the importance of medication adherence for smoking cessation among community corrections smokers. Providing exposure to medication may be a promising intervention to increase medication adherence and subsequent cessation rates in this population.",2017,"The strongest associate of medication adherence was previous use of bupropion, while the strongest associate of smoking abstinence was medication adherence.","['smokers under community corrections supervision', 'Five hundred participants under community corrections supervision', 'criminal justice individuals supervised in the community']",['smoking cessation counseling or no counseling in conjunction with 12weeks of bupropion treatment plus brief physician advice to quit'],"['cessation rates', 'medication adherence and subsequent cessation rates', 'medication adherence and smoking cessation', 'successful smoking cessation']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0086072', 'cui_str': 'Criminal Justice'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",500.0,0.0175474,"The strongest associate of medication adherence was previous use of bupropion, while the strongest associate of smoking abstinence was medication adherence.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Cropsey', 'Affiliation': 'University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology, Sparks Center 1016, 1720 2nd Ave. South, Birmingham, AL 35294, USA. Electronic address: kcropsey@uabmc.edu.'}, {'ForeName': 'C Brendan', 'Initials': 'CB', 'LastName': 'Clark', 'Affiliation': 'Wichita State University, Department of Psychology, Box 34, Wichita, Kansas 67260-0034, USA. Electronic address: C.brendan.clark@wichita.edu.'}, {'ForeName': 'Erin N', 'Initials': 'EN', 'LastName': 'Stevens', 'Affiliation': 'Auburn Psychology Group, LLC. 861-D North Dean Road, Auburn, AL 36830, USA. Electronic address: Erinsteven@gmail.com.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Schiavon', 'Affiliation': 'University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology, Sparks Center 1016, 1720 2nd Ave. South, Birmingham, AL 35294, USA. Electronic address: schiavon@uab.edu.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology, Sparks Center 1016, 1720 2nd Ave. South, Birmingham, AL 35294, USA. Electronic address: alahti@uabmc.edu.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hendricks', 'Affiliation': 'University of Alabama at Birmingham, School of Public Health, Department of Health Behavior, 227L Ryals Public Health Building, 1665 University Blvd., Birmingham, AL 35294, USA. Electronic address: phendricks@uab.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2016.10.010']
789,32414376,Implementation and adoption of a health insurance support tool in the electronic health record: a mixed methods analysis within a randomized trial.,"BACKGROUND
In addition to delivering vital health care to millions of patients in the United States, community health centers (CHCs) provide needed health insurance outreach and enrollment support to their communities. We developed a health insurance enrollment tracking tool integrated within the electronic health record (EHR) and conducted a hybrid implementation-effectiveness trial in a CHC-based research network to assess tool adoption using two implementation strategies.
METHODS
CHCs were recruited from the OCHIN practice-based research network. Seven health center systems (23 CHC clinic sites) were recruited and randomized to receive basic educational materials alone (Arm 1), or these materials plus facilitation (Arm 2) during the 18-month study period, September 2016-April 2018. Facilitation consisted of monthly contacts with clinic staff and utilized audit and feedback and guided improvement cycles. We measured total and monthly tool utilization from the EHR. We conducted structured interviews of CHC staff to assess factors associated with tool utilization. Qualitative data were analyzed using an immersion-crystallization approach with barriers and facilitators identified using the Consolidated Framework for Implementation Research.
RESULTS
The majority of CHCs in both study arms adopted the enrollment tool. The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01). However, by the end of the study period, the rate of tool utilization was similar in both arms; and observed between-arm differences in tool utilization were largely driven by a single, large health center in Arm 2. Perceived relative advantage of the tool was the key factor identified by clinic staff as driving tool utilization. Implementation climate and leadership engagement were also associated with tool utilization.
CONCLUSIONS
Using basic education materials and low-intensity facilitation, CHCs quickly adopted an EHR-based tool to support critical outreach and enrollment activities aimed at improving access to health insurance in their communities. Though facilitation carried some benefit, a CHC's perceived relative advantage of the tool was the primary driver of decisions to implement the tool.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT02355262, Posted February 4, 2015.",2020,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","['Seven health center systems (23 CHC clinic sites', 'CHCs were recruited from the OCHIN practice-based research network']","['health insurance enrollment tracking tool integrated within the electronic health record (EHR', 'basic educational materials alone']",['rate of tool utilization'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.135831,"The rate of tool utilization was, on average, higher in Arm 2 compared to Arm 1 (20.0% versus 4.7%, p < 0.01).","[{'ForeName': 'Brigit', 'Initials': 'B', 'LastName': 'Hatch', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA. adamusb@ohsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Tillotson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Huguet', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Marino', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baron', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Sumic', 'Affiliation': 'OCHIN, 1881 SW Naito Parkway, Portland, OR, 97201, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohen', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'E DeVoe', 'Affiliation': 'Oregon Health & Science University, 3405 SW Perimeter Court, Portland, OR, 97239, USA.'}]",BMC health services research,['10.1186/s12913-020-05317-z']
790,32414298,Adjusting for adherence in randomized trials when adherence is measured as a continuous variable: An application to the Lipid Research Clinics Coronary Primary Prevention Trial.,"BACKGROUND
Clinicians and patients may be more interested in per-protocol effect estimates than intention-to-treat effect estimates from randomized trials. However, per-protocol effect estimates may be biased due to insufficient adjustment for prognostic factors that predict adherence. Adjustment for this bias is possible when appropriate methods, such as inverse probability weighting, are used. But, when adherence is measured as a continuous variable, constructing these weights can be challenging.
METHODS
In the placebo arm of the Lipid Research Clinics Coronary Primary Prevention Trial, we estimated the 7-year cumulative incidence of coronary heart disease under 100% adherence and 0% adherence to placebo. We used dose-response discrete-hazards models with inverse probability weighting to adjust for pre- and post-randomization covariates. We considered several continuous distributions for constructing the inverse probability weights.
RESULTS
The risk difference estimate for 100% adherence compared with 0% adherence ranged from -7.7 to -6.1 percentage points without adjustment for baseline and post-baseline covariates, and ranged from -1.8 to 2.2 percentage points with adjustment using inverse probability weights, depending on the dose-response model and inverse probability weight distribution used.
CONCLUSIONS
Methods which appropriately adjust for time-varying post-randomization variables can explain away much of the bias in the ""effect"" of adherence to placebo. When considering continuous adherence, investigators should consider several models as estimates may be sensitive to the model chosen.",2020,"The risk difference estimate for 100% adherence compared with 0% adherence ranged from -7.7 to -6.1 percentage points without adjustment for baseline and post-baseline covariates, and ranged from -1.8 to 2.2 percentage points with adjustment using inverse probability weights, depending on the dose-response model and inverse probability weight distribution used.
",[],['placebo'],['7-year cumulative incidence of coronary heart disease'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]",,0.414986,"The risk difference estimate for 100% adherence compared with 0% adherence ranged from -7.7 to -6.1 percentage points without adjustment for baseline and post-baseline covariates, and ranged from -1.8 to 2.2 percentage points with adjustment using inverse probability weights, depending on the dose-response model and inverse probability weight distribution used.
","[{'ForeName': 'Kerollos Nashat', 'Initials': 'KN', 'LastName': 'Wanis', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Arin L', 'Initials': 'AL', 'LastName': 'Madenci', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Hernán', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Eleanor J', 'Initials': 'EJ', 'LastName': 'Murray', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520920893']
791,32492577,Associations Between Food Insecurity and Parental Feeding Behaviors of Toddlers.,"OBJECTIVE
We examined associations between household food insecurity status and parental feeding behavior, weight perception, and child weight status in a diverse sample of young children.
METHODS
Cross-sectional analysis of 2-year-old children in Greenlight, a cluster randomized trial to prevent childhood obesity. The exposure was food insecurity, defined as a positive response to a validated screen. Outcomes were parent feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status. t tests and linear regression were used to assess associations between food insecurity and each outcome. We adjusted for child sex, race/ethnicity, parent education, employment, site, number of children in the home, and Special Supplemental Nutrition Program for Women, Infants, and Children status.
RESULTS
Five hundred three households (37%) were food insecure. After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, P = .01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; P = .02). No differences were observed in monitoring or restrictive feeding behaviors. After adjusting for covariates, there was no difference in weight status or prevalence of overweight/obesity of children or parents based on household food insecurity status.
CONCLUSIONS
Parents from food insecure households reported more pressuring feeding behaviors. This finding underscores the need to address food insecurity and potentially prevent harmful effects on child feeding. Parents in food insecure households might benefit from linkage with resources and education to develop healthier feeding behaviors.",2020,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","['503 households (37%) were food insecure', '2-year old children in Greenlight, a cluster randomized trial to prevent childhood obesity', 'Toddlers']",[],"['pressuring feeding behaviors', 'monitoring or restrictive feeding behaviors', 'weight status or prevalence of overweight/obesity', 'feeding behaviors/beliefs measured by the Child Feeding Questionnaire and child weight status']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]",[],"[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",503.0,0.0299764,"After adjusting for covariates, parents from insecure households reported more pressuring feeding behaviors (mean factor score 3.2 compared to food secure parents mean factor score 2.9, p=0.01) and were more worried about their child becoming overweight (mean factor score 2.3 vs 2.0; p=0.02).","[{'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Orr', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel (CJ Orr and KB Flower), Chapel Hill, NC. Electronic address: colin_orr@med.unc.edu.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Ravanbakht', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine (S Ravanbakht and EM Perrin), Durham, NC.'}, {'ForeName': 'Kori B', 'Initials': 'KB', 'LastName': 'Flower', 'Affiliation': 'Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, University of North Carolina at Chapel (CJ Orr and KB Flower), Chapel Hill, NC.'}, {'ForeName': 'H Shonna', 'Initials': 'HS', 'LastName': 'Yin', 'Affiliation': 'Department of Pediatrics and Department of Population Health, New York University School of Medicine (HS Yin) New York, NY.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Division of General and Internal Medicine, Department of Medicine, Vanderbilt University Medical Center (RL Rothman), Nashville, Tenn; Center for Health Services Research, Vanderbilt University Medical Center (RL Rothman), Nashville, Tenn.'}, {'ForeName': 'Lee M', 'Initials': 'LM', 'LastName': 'Sanders', 'Affiliation': 'General Pediatrics, Department of Pediatrics, Stanford University of School of Medicine (LM Sanders), Stanford, Calif.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Delamater', 'Affiliation': 'Mailman Center for Child Development, University of Miami Miller School of Medicine (A Delamater), Miami, Fla.'}, {'ForeName': 'Eliana M', 'Initials': 'EM', 'LastName': 'Perrin', 'Affiliation': 'Department of Pediatrics and Duke Center for Childhood Obesity Research, Duke University School of Medicine (S Ravanbakht and EM Perrin), Durham, NC.'}]",Academic pediatrics,['10.1016/j.acap.2020.05.020']
792,30035576,Effects of nicotine deprivation on current pain intensity among daily cigarette smokers.,"Animal research has consistently demonstrated increased pain in the context of nicotine deprivation, and there is cross-sectional evidence that tobacco smokers may experience greater pain following periods of smoking abstinence. This study aimed to examine current pain intensity as a function of nicotine deprivation among 137 daily tobacco smokers who did not endorse chronic pain and were recruited to participate in a primary study of the effects of smoking abstinence on experimental pain reactivity. Participants were randomized to either deprivation (12-24 hr abstinence) or continued ad lib smoking conditions. Compliance with the manipulation was biochemically verified via expired carbon monoxide (CO). Current pain intensity was assessed at baseline (Session 1) and following the deprivation manipulation (Session 2) using a single item that asked participants to indicate their current level of pain on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). At baseline, the majority of participants (51.1%) reported no pain ( M = 1.75). As hypothesized, participants randomized to nicotine deprivation (vs. continued smoking) reported greater current pain intensity following the manipulation. Among smokers who reported no pain at baseline, those who abstained from smoking were nearly 3.5 times more likely to endorse pain at Session 2. These results suggest that daily tobacco smokers may experience greater pain during the first 12-24 hr of smoking abstinence. Future research should examine the role of pain in nicotine withdrawal, and whether tailored interventions may be needed to account for nicotine deprivation-induced amplification of pain. (PsycINFO Database Record (c) 2018 APA, all rights reserved).",2018,"At baseline, the majority of participants (51.1%) reported no pain ( M = 1.75).","['daily cigarette smokers', '137 daily tobacco smokers who did not endorse chronic pain']","['nicotine deprivation', 'deprivation (12-24 hr abstinence) or continued ad lib smoking conditions']","['current pain intensity', 'pain', 'Current pain intensity', 'endorse pain']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C3266136', 'cui_str': 'Daily tobacco smoker'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0466534,"At baseline, the majority of participants (51.1%) reported no pain ( M = 1.75).","[{'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'LaRowe', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jesse D', 'Initials': 'JD', 'LastName': 'Kosiba', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Zale', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Ditre', 'Affiliation': 'Department of Psychology.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000218']
793,30035580,"Alternate versions of a fixed-choice, delay-discounting assessment for repeated-measures designs.","Delay discounting, reflected in the tendency to prefer immediate rewards over delayed rewards, is associated with most forms of problematic substance use. When assessed multiple times to examine within-individual changes, for example, following acute drug administration or an intervention, shifts in delay discounting simply because of repeated assessment is a concern, particularly when the assessment task is identical. This may be true for the Monetary Choice Questionnaire (MCQ), a widely used, fixed-item assessment of delay discounting. The present research examined possible within-individual difference/equivalence of MCQ indices at test/retest. This was contrasted with within-individual difference/equivalence when using an alternate version of the MCQ at retest, specifically developed to maintain the assessment structure and scoring of the original MCQ but with different choice items. Eighty-four participants completed delay discounting at test and retest with a 1-week interval; participants were randomized to complete the MCQ at both test and retest (MCQ/MCQ; n = 43) or complete the MCQ at test and an alternate version of the MCQ at retest (MCQ/MCQ-A; n = 41). Conventional hypothesis testing indicated no significant changes in delay discounting in the MCQ/MCQ condition or MCQ/MCQ-A condition. However, equivalence analysis, which is able to established whether scores are statistically equivalent, indicated that test/retest scores were not equivalent in some cases. Specifically, only 1 magnitude in the MCQ/MCQ condition was equivalent at test/retest, whereas 2 magnitudes in the MCQ/MCQ-A condition were equivalent at test/retest. (PsycINFO Database Record (c) 2018 APA, all rights reserved).",2018,Conventional hypothesis testing indicated no significant changes in delay discounting in the MCQ/MCQ condition or MCQ/MCQ-A condition.,[],[],['delay discounting'],[],[],"[{'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}]",84.0,0.030216,Conventional hypothesis testing indicated no significant changes in delay discounting in the MCQ/MCQ condition or MCQ/MCQ-A condition.,"[{'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Kuang', 'Affiliation': 'Social Norms Group.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Milhorn', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Stuppy-Sullivan', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Health Education and Behavior.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Yi', 'Affiliation': 'Department of Health Education and Behavior.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000211']
794,32415211,Comparison of the use of opioids only and pregabalin add-on for the treatment of neuropathic pain in cervical myelopathy patients: a pilot trial.,"Among patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants were randomly assigned to one of the two study groups. The participants in one study group received opioids only, while those in the other group received opioids and pregabalin. Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group). The LANSS, neck pain, and arm pain scores in the pregabalin add-on group improved significantly compared with those in the opioid-only group after the first 4 weeks (p = 0.005, 0.001 and 0.035, respectively), but there was no significant difference between the two groups during the next 4 weeks (p = 0.615, 0.377 and 0.716, respectively). There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up. Adverse events were reported by four patients (20.0%) in the opioid-only group and five patients (26.3%) in the pregabalin add-on group (p = 0.716). However, over time, the occurrence of side effects and dropouts increased in the pregabalin add-on group. This exploratory pilot study suggests that pregabalin add-on treatment is more efficient than the use of opioids alone at the beginning of NP treatment in cervical myelopathy patients. However, prescribing pregabalin add-on treatment for more than four weeks should be done cautiously.",2020,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"['cervical myelopathy patients', 'patients with cervical myelopathy who were diagnosed with neuropathic pain (NP) by the LANSS test, the study participants', 'Thirty-nine patients were analyzed in the study (20 patients in the opioid-only group and 19 in the pregabalin add-on group']","['opioids only and pregabalin', 'pregabalin', 'opioids', 'opioids and pregabalin']","['LANSS, neck pain, and arm pain scores', 'neuropathic pain', 'neck disability index and EuroQol-5Dimension scores', 'Adverse events']","[{'cui': 'C0149645', 'cui_str': 'Cervical myelopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",39.0,0.0383874,There was no significant difference in the neck disability index and EuroQol-5Dimension scores after four weeks and eight weeks of follow-up.,"[{'ForeName': 'Jong-Myung', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Spine Center, Gachon University Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Chun Kee', 'Initials': 'CK', 'LastName': 'Chung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. chungc@snu.ac.kr.'}, {'ForeName': 'Chi Heon', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Heon', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]",Scientific reports,['10.1038/s41598-020-65108-8']
795,32492302,"Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children.","BACKGROUND
Rituximab added to chemotherapy prolongs survival among adults with B-cell cancer. Data on its efficacy and safety in children with high-grade, mature B-cell non-Hodgkin's lymphoma are limited.
METHODS
We conducted an open-label, international, randomized, phase 3 trial involving patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B (LMB) chemotherapy with standard LMB chemotherapy alone. The primary end point was event-free survival. Overall survival and toxic effects were also assessed.
RESULTS
Analyses were based on 328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma. The median follow-up was 39.9 months. Events were observed in 10 patients in the rituximab-chemotherapy group and in 28 in the chemotherapy group. Event-free survival at 3 years was 93.9% (95% confidence interval [CI], 89.1 to 96.7) in the rituximab-chemotherapy group and 82.3% (95% CI, 75.7 to 87.5) in the chemotherapy group (hazard ratio for primary refractory disease or first occurrence of progression, relapse after response, death from any cause, or second cancer, 0.32; 95% CI, 0.15 to 0.66; one-sided P = 0.00096, which reached the significance level required for this analysis). Eight patients in the rituximab-chemotherapy group died (4 deaths were disease-related, 3 were treatment-related, and 1 was from a second cancer), as did 20 in the chemotherapy group (17 deaths were disease-related, and 3 were treatment-related) (hazard ratio, 0.36; 95% CI, 0.16 to 0.82). The incidence of acute adverse events of grade 4 or higher after prephase treatment was 33.3% in the rituximab-chemotherapy group and 24.2% in the chemotherapy group (P = 0.07); events were related mainly to febrile neutropenia and infection. Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
CONCLUSIONS
Rituximab added to standard LMB chemotherapy markedly prolonged event-free survival and overall survival among children and adolescents with high-grade, high-risk, mature B-cell non-Hodgkin's lymphoma and was associated with a higher incidence of hypogammaglobulinemia and, potentially, more episodes of infection. (Funded by the Clinical Research Hospital Program of the French Ministry of Health and others; ClinicalTrials.gov number, NCT01516580.).",2020,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","['adults with B-cell cancer', ""children with high-grade, mature B-cell non-Hodgkin's lymphoma"", ""328 patients who underwent randomization (164 patients per group); 85.7% of the patients had Burkitt's lymphoma"", ""High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children"", ""patients younger than 18 years of age with high-risk, mature B-cell non-Hodgkin's lymphoma (stage III with an elevated lactate dehydrogenase level or stage IV) or acute leukemia to compare the addition of six doses of rituximab to standard lymphomes malins B ""]","['standard LMB chemotherapy', 'Rituximab', 'LMB) chemotherapy with standard LMB chemotherapy alone', 'rituximab-chemotherapy']","['Event-free survival', 'efficacy and safety', 'incidence of acute adverse events', 'febrile neutropenia and infection', 'prolonged event-free survival and overall survival', 'event-free survival', 'Overall survival and toxic effects']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0006413', 'cui_str': 'Burkitt lymphoma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0151754', 'cui_str': '[D]Lactic acid dehydrogenase raised'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0085669', 'cui_str': 'Acute leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",328.0,0.163524,"Approximately twice as many patients in the rituximab-chemotherapy group as in the chemotherapy group had a low IgG level 1 year after trial inclusion.
","[{'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Minard-Colin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Pillon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'G A Amos', 'Initials': 'GAA', 'LastName': 'Burke', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Barkauskas', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rafael F', 'Initials': 'RF', 'LastName': 'Delgado', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Alexander', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyttebroeck', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bollard', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'József', 'Initials': 'J', 'LastName': 'Zsiros', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Csoka', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Bernarda', 'Initials': 'B', 'LastName': 'Kazanowska', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Chiang', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Rodney R', 'Initials': 'RR', 'LastName': 'Miles', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Adamson', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Vassal', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Patte', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Gross', 'Affiliation': ""From the Departments of Pediatric and Adolescent Oncology (V.M.-C., C.P.) and Clinical Research (G.V.), INSERM Unité 1015 (V.M.-C.), and the Unit of Biostatistics and Epidemiology and INSERM Unité 1018 (A.A.), Gustave Roussy, Université Paris-Saclay, Villejuif, France; the Department of Pediatric Hematology and Oncology, University of Padua, Padua, Italy (M.P.); the Department of Paediatric Haematology, Oncology, and Palliative Care, Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge (G.A.A.B.), Cancer Research UK Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham (K.W.), and the Department of Histopathology, Royal Marsden NHS Foundation Trust, London (A.W.) - all in the United Kingdom; the Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles (D.A.B.); the Department of Pediatric Hematology and Oncology, University of Valencia, Valencia, Spain (R.F.D.); the Division of Haematology-Oncology, Hospital for Sick Children, Toronto (S.A.); the Department of Pediatric Hematology and Oncology, University Hospitals Leuven, Leuven, Belgium (A.U.); the Center for Cancer and Immunology Research, Children's National Health System and George Washington University, Washington, DC (C.M.B.); Princess Máxima Center for Pediatric Oncology, Utrecht, the Netherlands (J.Z.); the Department of Pediatric Hematology and Oncology, Semmelweis University, Budapest, Hungary (M.C.); the Department of Pediatric Bone Marrow Transplantation, Oncology, and Hematology, Wroclaw Medical University, Wroclaw, Poland (B.K.); the Department of Pediatrics and Adolescent Medicine, Li Ka Shing Faculty of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong (A.K.C.); the Department of Pathology, University of Utah, Salt Lake City (R.R.M.); Children's Hospital of Philadelphia, Philadelphia (P.C.A.); and the National Cancer Institute, Center for Global Health, Rockville, MD (T.G.G.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915315']
796,27274016,An electronic documentation system improves the quality of admission notes: a randomized trial.,"OBJECTIVE
There are concerns that structured electronic documentation systems can limit expressivity and encourage long and unreadable notes. We assessed the impact of an electronic clinical documentation system on the quality of admission notes for patients admitted to a general medical unit.
METHODS
This was a prospective randomized crossover study comparing handwritten paper notes to electronic notes on different patients by the same author, generated using a semistructured electronic admission documentation system over a 2-month period in 2014. The setting was a 4-team, 80-bed general internal medicine clinical teaching unit at a large urban academic hospital. The quality of clinical documentation was assessed using the QNOTE instrument (best possible score = 100), and word counts were assessed for free-text sections of notes.
RESULTS
Twenty-one electronic-paper note pairs (42 notes) written by 21 authors were randomly drawn from a pool of 303 eligible notes. Overall note quality was significantly higher in electronic vs paper notes (mean 90 vs 69, P < .0001). The quality of free-text subsections (History of Present Illness and Impression and Plan) was significantly higher in the electronic vs paper notes (mean 93 vs 78, P < .0001; and 89 vs 77, P = .001, respectively). The History of Present Illness subsection was significantly longer in electronic vs paper notes (mean 172.4 vs 92.4 words, P = .0001).
CONCLUSIONS
An electronic admission documentation system improved both the quality of free-text content and the overall quality of admission notes. Authors wrote more in the free-text sections of electronic documents as compared to paper versions.",2017,"Overall note quality was significantly higher in electronic vs paper notes (mean 90 vs 69, P < .0001).","['handwritten paper notes to electronic notes on different patients by the same author, generated using a semistructured electronic admission documentation system over a 2-month period in 2014', 'patients admitted to a general medical unit', 'Twenty-one electronic-paper note pairs (42 notes) written by 21 authors were randomly drawn from a pool of 303 eligible notes', '80-bed general internal medicine clinical teaching unit at a large urban academic hospital']",['electronic clinical documentation system'],"['quality of admission notes', 'quality of free-text subsections (History of Present Illness and Impression and Plan', 'Overall note quality', 'quality of clinical documentation']","[{'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3812881', 'cui_str': 'Writer (occupation)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}]",303.0,0.0659332,"Overall note quality was significantly higher in electronic vs paper notes (mean 90 vs 69, P < .0001).","[{'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Jamieson', 'Affiliation': ""Division of General Internal Medicine, St. Michael's Hospital, Toronto, Ontario, Canada jamiesont@smh.ca.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ailon', 'Affiliation': ""Division of General Internal Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Chien', 'Affiliation': ""Division of General Internal Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ophyr', 'Initials': 'O', 'LastName': 'Mourad', 'Affiliation': ""Division of General Internal Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.""}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocw064']
797,27357833,Translating evidence to practice in the health professions: a randomized trial of Twitter vs Facebook.,"Objective
Our objective was to compare the change in research informed knowledge of health professionals and their intended practice following exposure to research information delivered by either Twitter or Facebook.
Methods
This open label comparative design study randomized health professional clinicians to receive ""practice points"" on tendinopathy management via Twitter or Facebook. Evaluated outcomes included knowledge change and self-reported changes to clinical practice.
Results
Four hundred and ninety-four participants were randomized to 1 of 2 groups and 317 responders analyzed. Both groups demonstrated improvements in knowledge and reported changes to clinical practice. There was no statistical difference between groups for the outcomes of knowledge change (P = .728), changes to clinical practice (P = .11) or the increased use of research information (P = .89). Practice points were shared more by the Twitter group (P < .001); attrition was lower in the Facebook group (P < .001).
Conclusion
Research information delivered by either Twitter or Facebook can improve clinician knowledge and promote behavior change. No differences in these outcomes were observed between the Twitter and Facebook groups. Brief social media posts are as effective as longer posts for improving knowledge and promoting behavior change. Twitter may be more useful in publicizing information and Facebook for encouraging course completion.",2017,"There was no statistical difference between groups for the outcomes of knowledge change (P = .728), changes to clinical practice (P = .11) or the increased use of research information (P = .89).",['Four hundred and ninety-four participants were randomized to 1 of 2 groups and 317 responders analyzed'],"['Twitter or Facebook', 'Facebook']","['clinician knowledge and promote behavior change', 'changes to clinical practice', 'knowledge change and self-reported changes to clinical practice', 'attrition', 'knowledge change']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}]",494.0,0.0570224,"There was no statistical difference between groups for the outcomes of knowledge change (P = .728), changes to clinical practice (P = .11) or the increased use of research information (P = .89).","[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tunnecliff', 'Affiliation': 'Department of Physiotherapy, Monash University, Frankston, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Weiner', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Gaida', 'Affiliation': 'Discipline of Physiotherapy and University of Canberra Research Institute for Sport and Exercise (UCRISE), University of Canberra, Canberra, Australia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Keating', 'Affiliation': 'Department of Physiotherapy, Monash University, Frankston, Australia.'}, {'ForeName': 'Prue', 'Initials': 'P', 'LastName': 'Morgan', 'Affiliation': 'Department of Physiotherapy, Monash University, Frankston, Australia.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Ilic', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Clearihan', 'Affiliation': 'School of Primary Health, Monash University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Davies', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, United Kingdom.'}, {'ForeName': 'Sivalal', 'Initials': 'S', 'LastName': 'Sadasivan', 'Affiliation': 'JC School of Medicine & Health Sciences, Monash University, Malaysia.'}, {'ForeName': 'Patitapaban', 'Initials': 'P', 'LastName': 'Mohanty', 'Affiliation': 'Swami Vivekanand National Institute of Rehabilitation Training and Research, Odisha, India.'}, {'ForeName': 'Shankar', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'Swami Vivekanand National Institute of Rehabilitation Training and Research, Odisha, India.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Reynolds', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Maloney', 'Affiliation': 'Department of Physiotherapy, Monash University, Frankston, Australia.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocw085']
798,32059641,QUality improvement in primary care to prevent hospitalisations and improve Effectiveness and efficiency of care for people Living with coronary heart disease (QUEL): protocol for a 24-month cluster randomised controlled trial in primary care.,"BACKGROUND
Cardiovascular disease (CVD), including coronary heart disease (CHD) and stroke, is the leading cause of death and disability globally. A large proportion of mortality occurs in people with prior CHD and effective and scalable strategies are needed to prevent associated deaths and hospitalisations. The aim of this study is to determine if a practice-level collaborative quality improvement program, focused on patients with CHD, reduces the rate of unplanned CVD hospitalisations and major adverse cardiovascular events, and increases the proportion of patients achieving risk factor targets at 24 months.
METHODS
Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up. Eligible practices will be randomised (1:1) to participate in either the intervention (collaborative quality improvement program) or control (standard care) regimens. Outcomes will be assessed based on randomised allocation, according to intention-to-treat. The primary outcome is the proportion of patients with unplanned CVD hospitalisations at 2 years. Secondary outcomes are proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review. Differences in the proportion of patients who are hospitalised (as well as binary secondary outcomes) will be analysed using log-binomial regression or robust Poisson regression, if necessary.
DISCUSSION
Despite extensive research with surrogate outcomes, to the authors' knowledge, this is the first randomised controlled trial to evaluate the effectiveness of a data-driven collaborative quality improvement intervention on hospitalisations, CVD events and cardiovascular risk amongst patients with CHD in the primary care setting. The use of data linkage for collection of outcomes will enable evaluation of this potentially efficient strategy for improving management of risk and outcomes for people with heart disease.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR) number ACTRN12619001790134 (dated 20th December 2019).",2020,"METHODS
Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up.","['people with heart disease', 'people Living with coronary heart disease (QUEL', 'patients with CHD', '50 primary care practices (n~\u200910,000 patients) with 24-month follow-up', 'patients with CHD in the primary care setting']","['primary care quality improvement program', 'intervention (collaborative quality improvement program) or control (standard care) regimens']","['proportion of patients with major adverse cardiovascular events, proportion of patients who received prescriptions for guideline-recommended medicines, proportion of patients achieving national risk factor targets and proportion with a chronic disease management plan or review', 'hospitalisations, CVD events and cardiovascular risk', 'rate of unplanned CVD hospitalisations and major adverse cardiovascular events', 'Effectiveness and efficiency of care', 'proportion of patients with unplanned CVD hospitalisations']","[{'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",10000.0,0.1362,"METHODS
Cluster randomised controlled trial (cRCT) to evaluate the effectiveness of a primary care quality improvement program in 50 primary care practices (n~ 10,000 patients) with 24-month follow-up.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, PO Box 154 Westmead, Sydney, NSW, 2154, Australia. julie.redfern@sydney.edu.au.'}, {'ForeName': 'Nashid', 'Initials': 'N', 'LastName': 'Hafiz', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, PO Box 154 Westmead, Sydney, NSW, 2154, Australia.'}, {'ForeName': 'Karice', 'Initials': 'K', 'LastName': 'Hyun', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, PO Box 154 Westmead, Sydney, NSW, 2154, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Primary ageind Integrated Care Unit, South Western Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hespe', 'Affiliation': 'School of Medicine Sydney, The University of Notre Dame Australia, Sydney, Australia.'}, {'ForeName': 'Clara K', 'Initials': 'CK', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, Faculty of Medicine and Health, The University of Sydney, PO Box 154 Westmead, Sydney, NSW, 2154, Australia.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Briffa', 'Affiliation': 'School of Population and Global Health, Faculty of Health and Medical Sciences, The University of Western Australia, Sydney, Australia.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Gallagher', 'Affiliation': 'Sydney Nursing School, Faculty of Medcine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University and School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hare', 'Affiliation': 'Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Austin Health, Heidelberg, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'Faculty of Health Sciences & Medicine, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Atkins', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Tracey-Lea', 'Initials': 'TL', 'LastName': 'Laba', 'Affiliation': 'Centre for Health Economics Research and Evaluation, University of Technology, Sydney, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Halcomb', 'Affiliation': 'School of Nursing, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Johnson', 'Affiliation': 'Inala Primary Care, Brisbane, Queensland, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia.'}]",BMC family practice,['10.1186/s12875-020-01105-0']
799,32416072,"Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.","BACKGROUND
Isocitrate dehydrogenase 1 (IDH1) mutations occur in approximately 13% of patients with intrahepatic cholangiocarcinoma, a relatively uncommon cancer with a poor clinical outcome. The aim of this international phase 3 study was to assess the efficacy and safety of ivosidenib (AG-120)-a small-molecule targeted inhibitor of mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma.
METHODS
This multicentre, randomised, double-blind, placebo-controlled, phase 3 study included patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1. Patients were randomly assigned (2:1) with a block size of 6 and stratified by number of previous systemic treatment regimens for advanced disease to oral ivosidenib 500 mg or matched placebo once daily in continuous 28-day cycles, by means of an interactive web-based response system. Placebo to ivosidenib crossover was permitted on radiological progression per investigator assessment. The primary endpoint was progression-free survival by independent central review. The intention-to-treat population was used for the primary efficacy analyses. Safety was assessed in all patients who had received at least one dose of ivosidenib or placebo. Enrolment is complete; this study is registered with ClinicalTrials.gov, NCT02989857.
FINDINGS
Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients were randomly assigned to ivosidenib (n=124) or placebo (n=61). Median follow-up for progression-free survival was 6·9 months (IQR 2·8-10·9). Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001). The most common grade 3 or worse adverse event in both treatment groups was ascites (four [7%] of 59 patients receiving placebo and nine [7%] of 121 patients receiving ivosidenib). Serious adverse events were reported in 36 (30%) of 121 patients receiving ivosidenib and 13 (22%) of 59 patients receiving placebo. There were no treatment-related deaths.
INTERPRETATION
Progression-free survival was significantly improved with ivosidenib compared with placebo, and ivosidenib was well tolerated. This study shows the clinical benefit of targeting IDH1 mutations in advanced, IDH1-mutant cholangiocarcinoma.
FUNDING
Agios Pharmaceuticals.",2020,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"['mutated IDH1-in patients with previously treated IDH1-mutant cholangiocarcinoma', 'patients from 49 hospitals in six countries aged at least 18 years with histologically confirmed, advanced, IDH1-mutant cholangiocarcinoma who had progressed on previous therapy, and had up to two previous treatment regimens for advanced disease, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and a measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1', 'Between Feb 20, 2017, and Jan 31, 2019, 230 patients were assessed for eligibility, and as of the Jan 31, 2019 data cutoff date, 185 patients']","['Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy', 'ivosidenib or placebo', 'Placebo', 'oral ivosidenib 500 mg or matched placebo', 'ivosidenib', 'ivosidenib (AG-120)-a small-molecule targeted inhibitor', 'placebo']","['Safety', 'tolerated', 'progression-free survival', 'Median follow-up for progression-free survival', 'adverse event', 'efficacy and safety', 'Progression-free survival', 'Serious adverse events']","[{'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C4682397', 'cui_str': 'ivosidenib'}, {'cui': 'C0022157', 'cui_str': 'Isocitrate dehydrogenase'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3827169', 'cui_str': 'AG-120'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",230.0,0.76452,Progression-free survival was significantly improved with ivosidenib compared with placebo (median 2·7 months [95% CI 1·6-4·2] vs 1·4 months [1·4-1·6]; hazard ratio 0·37; 95% CI 0·25-0·54; one-sided p<0·0001).,"[{'ForeName': 'Ghassan K', 'Initials': 'GK', 'LastName': 'Abou-Alfa', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Medical College at Cornell University, New York, NY, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Milind M', 'Initials': 'MM', 'LastName': 'Javle', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Kelley', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lubner', 'Affiliation': 'Department of Medicine, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Adeva', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mitesh J', 'Initials': 'MJ', 'LastName': 'Borad', 'Affiliation': 'Department of Hematology-Oncology, Mayo Clinic Cancer Center, Phoenix, AZ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'Department of Medical Oncology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Harris', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Murphy', 'Affiliation': 'Department of Oncology-Gastrointestinal Cancer, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Do-Youn', 'Initials': 'DY', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Whisenant', 'Affiliation': 'Medical Oncology and Hematology, Utah Cancer Specialists, Salt Lake City, UT, USA.'}, {'ForeName': 'Maeve A', 'Initials': 'MA', 'LastName': 'Lowery', 'Affiliation': 'Trinity St James Cancer Institute, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachna T', 'Initials': 'RT', 'LastName': 'Shroff', 'Affiliation': 'Department of Medicine, University of Arizona Cancer Center, Tucson, AZ, USA.'}, {'ForeName': 'Anthony B', 'Initials': 'AB', 'LastName': 'El-Khoueiry', 'Affiliation': 'Department of Medicine, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Fan', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Christina X', 'Initials': 'CX', 'LastName': 'Chamberlain', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Liewen', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Gliser', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Shuchi S', 'Initials': 'SS', 'LastName': 'Pandya', 'Affiliation': 'Agios Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Manchester, UK; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA; Jiahui International Cancer Center, Jiahui Health, Shanghai, China. Electronic address: azhu@mgh.harvard.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30157-1']
800,31888944,"Exploring the experiences of people in Ontario, Canada who have trouble affording medicines: a qualitative concept mapping study.","OBJECTIVES
The experiences of people who report cost-related medicine non-adherence are not well documented. We aimed to present experiences relating to accessing medicines reported by the participants in a randomised controlled trial of free medicine distribution.
METHODS
The trial consisted of primary care patients from a large urban family practice and three rural family practices who reported cost-related medicine non-adherence. Participants were randomly allocated to continue their poor access (control) or to receive free and easily accessible medicines (intervention). As part of data collection for the first year of the trial, participants were asked closed and open-ended questions to assess their adherence to medication, health outcomes and their experiences in relation to medicine accessibility. We conducted a qualitative concept mapping study in which we analysed and summarised participants' responses to the open-ended question on a concept map to visually present their experiences relating to accessing medicines.
RESULTS
Of the 524 trial participants contacted, 198 (38%) responded to the open-ended question. The concept map contains clusters that represent eight types of experiences of participants related to medicine access including stress, relationship with doctor, health impact, quality of life, sacrificing other essentials, medicines are expensive, financial impact and adherence. These experiences fall under two major themes, experiences relating to personal finances and experiences relating to well-being, which are bridged by a central cluster of adherence.
CONCLUSIONS
The experiences shared by the participants demonstrate that access to medicines impacts people's finances and well-being as well as their adherence to prescribed medicines. These results indicate that effects on personal finances and general well-being should be measured for interventions and policy changes aimed at improving medicine access.
TRIAL REGISTRATION NUMBER
This article is linked to the Carefully Selected and Easily Accessible at No Charge Medicines (CLEAN Meds) randomised controlled trial (trial registration number: NCT02744963).",2019,Participants were randomly allocated to continue their poor access (control) or to receive free and easily accessible medicines (intervention).,"['experiences of people in Ontario, Canada who have trouble affording medicines', 'Of the 524 trial participants contacted, 198 (38%) responded to the open-ended question', 'primary care patients from a large urban family practice and three rural family practices who reported cost-related medicine non-adherence']",['continue their poor access (control) or to receive free and easily accessible medicines (intervention'],[],"[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",[],,0.0920864,Participants were randomly allocated to continue their poor access (control) or to receive free and easily accessible medicines (intervention).,"[{'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Yaphe', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Itunuoluwa', 'Initials': 'I', 'LastName': 'Adekoya', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Darshanand', 'Initials': 'D', 'LastName': 'Maraj', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Nav', 'Initials': 'N', 'LastName': 'Persaud', 'Affiliation': ""MAP Centre for Urban Health Solutions, St. Michael's Hospital, Toronto, Ontario, Canada nav.persaud@utoronto.ca.""}]",BMJ open,['10.1136/bmjopen-2019-033933']
801,29809024,"Sustaining sleep: Results from the randomized controlled work, family, and health study.","Although calls for intervention designs are numerous within the organizational literature and increasing efforts are being made to conduct rigorous randomized controlled trials, existing studies have rarely evaluated the long-term sustainability of workplace health intervention outcomes, or mechanisms of this process. This is especially the case with regard to objective and subjective sleep outcomes. We hypothesized that a work-family intervention would increase both self-reported and objective actigraphic measures of sleep quantity and sleep quality at 6 and 18 months post-baseline in a sample of information technology workers from a U.S. Fortune 500 company. Significant intervention effects were found on objective actigraphic total sleep time and self-reported sleep insufficiency at the 6- and 18-month follow-up, with no significant decay occurring over time. However, no significant intervention effects were found for objective actigraphic wake after sleep onset or self-reported insomnia symptoms. A significant indirect effect was found for the effect of the intervention on objective actigraphic total sleep time through the proximal intervention target of 6-month control over work schedule and subsequent more distal 12-month family time adequacy. These results highlight the value of long-term occupational health intervention research, while also highlighting the utility of this work-family intervention with respect to some aspects of sleep. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"However, no significant intervention effects were found for objective actigraphic wake after sleep onset or self-reported insomnia symptoms.",['Sustaining sleep'],[],"['objective actigraphic total sleep time', 'objective actigraphic total sleep time and self-reported sleep insufficiency', 'objective actigraphic wake after sleep onset or self-reported insomnia symptoms', 'objective actigraphic measures of sleep quantity and sleep quality']","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",[],"[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0221527,"However, no significant intervention effects were found for objective actigraphic wake after sleep onset or self-reported insomnia symptoms.","[{'ForeName': 'Tori L', 'Initials': 'TL', 'LastName': 'Crain', 'Affiliation': 'Department of Psychology, Colorado State University.'}, {'ForeName': 'Leslie B', 'Initials': 'LB', 'LastName': 'Hammer', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health and Science University.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Bodner', 'Affiliation': 'Department of Psychology, Portland State University.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Olson', 'Affiliation': 'Oregon Institute of Occupational Health Sciences, Oregon Health and Science University.'}, {'ForeName': 'Ellen Ernst', 'Initials': 'EE', 'LastName': 'Kossek', 'Affiliation': 'Krannert School of Management, Purdue University.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Moen', 'Affiliation': 'Department of Sociology, University of Minnesota.'}, {'ForeName': 'Orfeu M', 'Initials': 'OM', 'LastName': 'Buxton', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University.'}]",Journal of occupational health psychology,['10.1037/ocp0000122']
802,26947331,"Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.","BACKGROUND
In the PALOMA-3 study, the combination of the CDK4 and CDK6 inhibitor palbociclib and fulvestrant was associated with significant improvements in progression-free survival compared with fulvestrant plus placebo in patients with metastatic breast cancer. Identification of patients most suitable for the addition of palbociclib to endocrine therapy after tumour recurrence is crucial for treatment optimisation in metastatic breast cancer. We aimed to confirm our earlier findings with this extended follow-up and show our results for subgroup and biomarker analyses.
METHODS
In this multicentre, double-blind, randomised phase 3 study, women aged 18 years or older with hormone-receptor-positive, HER2-negative metastatic breast cancer that had progressed on previous endocrine therapy were stratified by sensitivity to previous hormonal therapy, menopausal status, and presence of visceral metastasis at 144 centres in 17 countries. Eligible patients-ie, any menopausal status, Eastern Cooperative Oncology Group performance status 0-1, measurable disease or bone disease only, and disease relapse or progression after previous endocrine therapy for advanced disease during treatment or within 12 months of completion of adjuvant therapy-were randomly assigned (2:1) via a centralised interactive web-based and voice-based randomisation system to receive oral palbociclib (125 mg daily for 3 weeks followed by a week off over 28-day cycles) plus 500 mg fulvestrant (intramuscular injection on days 1 and 15 of cycle 1; then on day 1 of subsequent 28-day cycles) or placebo plus fulvestrant. The primary endpoint was investigator-assessed progression-free survival. Analysis was by intention to treat. We also assessed endocrine therapy resistance by clinical parameters, quantitative hormone-receptor expression, and tumour PIK3CA mutational status in circulating DNA at baseline. This study is registered with ClinicalTrials.gov, NCT01942135.
FINDINGS
Between Oct 7, 2013, and Aug 26, 2014, 521 patients were randomly assigned, 347 to fulvestrant plus palbociclib and 174 to fulvestrant plus placebo. Study enrolment is closed and overall survival follow-up is in progress. By March 16, 2015, 259 progression-free-survival events had occurred (145 in the fulvestrant plus palbociclib group and 114 in the fulvestrant plus placebo group); median follow-up was 8·9 months (IQR 8·7-9·2). Median progression-free survival was 9·5 months (95% CI 9·2-11·0) in the fulvestrant plus palbociclib group and 4·6 months (3·5-5·6) in the fulvestrant plus placebo group (hazard ratio 0·46, 95% CI 0·36-0·59, p<0·0001). Grade 3 or 4 adverse events occurred in 251 (73%) of 345 patients in the fulvestrant plus palbociclib group and 38 (22%) of 172 patients in the fulvestrant plus placebo group. The most common grade 3 or 4 adverse events were neutropenia (223 [65%] in the fulvestrant plus palbociclib group and one [1%] in the fulvestrant plus placebo group), anaemia (ten [3%] and three [2%]), and leucopenia (95 [28%] and two [1%]). Serious adverse events (all causalities) occurred in 44 patients (13%) of 345 in the fulvestrant plus palbociclib group and 30 (17%) of 172 patients in the fulvestrant plus placebo group. PIK3CA mutation was detected in the plasma DNA of 129 (33%) of 395 patients for whom these data were available. Neither PIK3CA status nor hormone-receptor expression level significantly affected treatment response.
INTERPRETATION
Fulvestrant plus palbociclib was associated with significant and consistent improvement in progression-free survival compared with fulvestrant plus placebo, irrespective of the degree of endocrine resistance, hormone-receptor expression level, and PIK3CA mutational status. The combination could be considered as a therapeutic option for patients with recurrent hormone-receptor-positive, HER2-negative metastatic breast cancer that has progressed on previous endocrine therapy.
FUNDING
Pfizer.",2016,"Median progression-free survival was 9·5 months (95% CI 9·2-11·0) in the fulvestrant plus palbociclib group and 4·6 months (3·5-5·6) in the fulvestrant plus placebo group (hazard ratio 0·46, 95% CI 0·36-0·59, p<0·0001).","['patients with recurrent hormone-receptor-positive, HER2-negative metastatic breast cancer that has progressed on previous endocrine therapy', 'women aged 18 years or older with hormone-receptor-positive, HER2-negative metastatic breast cancer that had progressed on previous endocrine therapy were stratified by sensitivity to previous hormonal therapy, menopausal status, and presence of visceral metastasis at 144 centres in 17 countries', 'patients with metastatic breast cancer', 'for advanced disease during treatment or within 12 months of completion of adjuvant therapy-were randomly assigned (2:1) via a', 'Eligible patients', 'Between Oct 7, 2013, and Aug 26, 2014, 521 patients were randomly assigned, 347 to']","['fulvestrant (intramuscular injection', 'endocrine therapy', 'placebo plus fulvestrant', 'Fulvestrant plus palbociclib versus fulvestrant plus placebo', 'fulvestrant plus placebo', 'fulvestrant plus palbociclib', 'centralised interactive web-based and voice-based randomisation system to receive oral palbociclib']","['PIK3CA status nor hormone-receptor expression level', 'Serious adverse events', 'investigator-assessed progression-free survival', '259 progression-free-survival events', 'neutropenia', 'leucopenia', 'progression-free survival', 'anaemia', 'Grade 3 or 4 adverse events', 'Median progression-free survival', 'endocrine resistance, hormone-receptor expression level, and PIK3CA mutational status', 'measurable disease or bone disease only, and disease relapse or progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0005940', 'cui_str': 'Bone Diseases'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",521.0,0.736104,"Median progression-free survival was 9·5 months (95% CI 9·2-11·0) in the fulvestrant plus palbociclib group and 4·6 months (3·5-5·6) in the fulvestrant plus placebo group (hazard ratio 0·46, 95% CI 0·36-0·59, p<0·0001).","[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Cristofanilli', 'Affiliation': 'Robert H Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Chicago, IL, USA. Electronic address: massimo.cristofanilli@nm.org.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Institute of Cancer Research and Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Dnipropetrovsk Medical Academy, City Multiple-Discipline Clinical Hospital #4, Dnipropetrovsk, Ukraine.'}, {'ForeName': 'Jungsil', 'Initials': 'J', 'LastName': 'Ro', 'Affiliation': 'National Cancer Center, Goyang-si, South Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'NHO Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Istituto Europeo di Oncologia, Milan, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'Center for Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, East Melbourne, VIC, Australia.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': 'Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; Tom Baker Cancer Centre, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Brustzentrum der Universität München (LMU), Munich, Germany.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Kathy Puyana', 'Initials': 'KP', 'LastName': 'Theall', 'Affiliation': 'Pfizer, Cambridge, MA, USA.'}, {'ForeName': 'Yuqiu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Pfizer, San Diego, CA, USA.'}, {'ForeName': 'Cynthia Huang', 'Initials': 'CH', 'LastName': 'Bartlett', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Koehler', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Slamon', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(15)00613-0']
803,31811151,Development and implementation of a nurse-led allergy clinic model in primary care: feasibility trial protocol.,"In the United Kingdom, there are acknowledged short comings in allergy care provision for patients seen in primary care. There is a lack of allergy training for healthcare professionals and this leads to inappropriate referrals to the limited number of allergy specialists. The primary aims of this study are to assess the feasibility of delivering and evaluating a new nurse-led allergy service in primary care, measured by recruitment, retention and quality of life. This is a single arm feasibility trial in which up to 250 participants referred to the nurse-led allergy clinic will receive the intervention and complete 6-12 weeks follow-up before being referred back to their usual care. Primary outcomes for this study will be establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures. Secondary outcomes will be acceptability of the new service to participants/carers and healthcare professionals. A sample of participants and professional stakeholders will take part in more in-depth semi-structured qualitative interviews. Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.",2019,Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.,"['250 participants referred to the nurse-led allergy clinic', 'primary care']",[],"['establishment of clinics, recruitment and retention rates, and estimates of change in disease-specific quality of life measures', 'acceptability of the new service to participants/carers and healthcare professionals', 'retention and quality of life']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3810819', 'cui_str': 'Allergy clinic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C1704312', 'cui_str': 'Healthcare professional (occupation)'}]",250.0,0.13893,Data from this feasibility trial will be used to inform plans for a pilot randomised controlled trial of nurse-led allergy clinics.,"[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Kelman', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hammersley', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK. vicky.hammersley@ed.ac.uk.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Kendall', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Mome', 'Initials': 'M', 'LastName': 'Mukherjee', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morrice', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Harley', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Schwarze', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Usher Institute, The University of Edinburgh, Old Medical School Teviot Place, Edinburgh, EH8, 9AG, UK.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-019-0155-5']
804,31822740,Perceptual vision training in non-sport-specific context: effect on performance skills and cognition in young females.,"Although an increasing interest in vision training for sport performance, whether it may have a transfer to sport-specific skills and whether such transfer could be mediated by cognition remain open issues. To enlighten this point, we tested the effect of 6-weeks sport vision training programmes (requiring generic or volleyball-specific motor actions) in non-sport-specific context compared to a third group performing traditional volleyball training in sport-specific context. Fifty-one female volleyball players were randomly assigned to one of three groups. Before and after training period subjects were tested on accuracy of volleyball-specific skills and cognitive performance (clinical reaction time, executive control, perceptual speed). Accuracy of volleyball-specific skills improved after traditional volleyball training with respect to the vision training groups. Conversely, vision training groups improved cognitive performance (clinical reaction time, executive control and perceptual speed), as compared to traditional volleyball training group. Our results have shown that vision training in non-sport-specific context (both generic or with specific motor actions) improved cognitive performance, but seems to be less effective for improving sport-specific skills. These evidences suggest that environment in which exercises were performed plays a key role to improve perception and action in sport-specific skills, supporting the ecological approach to sport learning.",2019,"Conversely, vision training groups improved cognitive performance (clinical reaction time, executive control and perceptual speed), as compared to traditional volleyball training group.","['young females', 'Fifty-one female volleyball players']","['traditional volleyball training', '6-weeks sport vision training programmes (requiring generic or volleyball-specific motor actions', 'Perceptual vision training', 'vision training']","['accuracy of volleyball-specific skills and cognitive performance (clinical reaction time, executive control, perceptual speed', 'cognitive performance', 'cognitive performance (clinical reaction time, executive control and perceptual speed', 'Accuracy of volleyball-specific skills']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",51.0,0.0113783,"Conversely, vision training groups improved cognitive performance (clinical reaction time, executive control and perceptual speed), as compared to traditional volleyball training group.","[{'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Formenti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy. damiano.formenti@unimi.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Duca', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Trecroci', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ansaldi', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bonfanti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Alberti', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, via Kramer 4/A, 20129, Milano, Italy.'}, {'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Iodice', 'Affiliation': 'Institute of Cognitive Sciences and Technologies, National Research Council, Via S. Martino della Battaglia 44, 00185, Rome, Italy.'}]",Scientific reports,['10.1038/s41598-019-55252-1']
805,32090788,Antidepressants effects of Rhodiola capsule combined with sertraline for major depressive disorder: A randomized double-blind placebo-controlled clinical trial.,"BACKGROUND
We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola Capsule for mild to moderate major depressive disorder(MDD).
METHODS
It is a randomized double-blind placebo-controlled clinical trial which 100 patients were randomized to 12 weeks into three groups. One of which (group A: 33 patients) received one sertraline and two placebos(0.6 g/day) tablets daily, a second (group B: 33 patients) received one sertraline and two Rhodiola capsules (0.6 g/day) daily, and a third (group C: 34 patients) received one sertraline,one placebo tablet and one tablet of Rhodiola capsule (0.3 g/day)daily. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores were examined. Significant post-treatment improvements were observed for both groups (Rhodiola Capsule) in HAMD, BDI, and CGI scores. The decline in HAMD, BDI, and CGI scores was greater for group B versus group A and C.While the CGI (versus group A) were greater for group B and C.
RESULTS
Statistically significant reductions were observed for HAM-D, BDI, and CGI scores for all treatment conditions with significant difference between groups. The decline in HAM-D, BDI, and CGI scores was greater for group B versus group C and A.
CONCLUSIONS
It is concluded that the Rhodiola capsule shows anti-depressive potency in patients with depression disorder when administered in dosages of either 0.3 or 0.6 g/day over a 12-week period.Rhodiola capsule can improve the quality of life and clinical symptoms.The high doses of Rhodiola capsule are better than the lower doses.",2020,"The decline in HAMD, BDI, and CGI scores was greater for group B versus group A and C.While the CGI (versus group A) were greater for group B and C.
","['mild to moderate major depressive disorder(MDD', 'patients with depression disorder', 'major depressive disorder', '100 patients']","['Rhodiola capsule combined with sertraline', 'sertraline and two placebos(0.6', 'placebo', 'sertraline and two Rhodiola capsules', 'Rhodiola Capsule', 'sertraline,one placebo tablet and one tablet of Rhodiola capsule']","['Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores', 'HAM-D, BDI, and CGI scores', 'HAMD, BDI, and CGI scores', 'quality of life and clinical symptoms']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0950013', 'cui_str': 'Rhodiola'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.505305,"The decline in HAMD, BDI, and CGI scores was greater for group B versus group A and C.While the CGI (versus group A) were greater for group B and C.
","[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China. Electronic address: gaolilidexingfu@163.com.'}, {'ForeName': 'Chenghan', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Yuansheng', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China.'}, {'ForeName': 'Jinmin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology and psychiatry, The second Affiliated Hospital of Fujian Traditional Chinese Medical University, Fuzhou, Fujian, China.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.065']
806,26547399,Effects of Placental Transfusion on Neonatal and 18 Month Outcomes in Preterm Infants: A Randomized Controlled Trial.,"OBJECTIVE
To assess the effect of delayed cord clamping (DCC) vs immediate cord clamping (ICC) on intraventricular hemorrhage (IVH), late onset sepsis (LOS), and 18-month motor outcomes in preterm infants.
STUDY DESIGN
Women (n = 208) in labor with singleton fetuses (<32 weeks gestation) were randomized to either DCC (30-45 seconds) or ICC (<10 seconds). The primary outcomes were IVH, LOS, and motor outcomes at 18-22 months corrected age. Intention-to-treat was used for primary analyses.
RESULTS
Cord clamping time was 32 ± 16 (DCC) vs 6.6 ± 6 (ICC) seconds. Infants in the DCC and ICC groups weighed 1203 ± 352 and 1136 ± 350 g and mean gestational age was 28.3 ± 2 and 28.4 ± 2 weeks, respectively. There were no differences in rates of IVH or LOS between groups. At 18-22 months, DCC was protective against motor scores below 85 on the Bayley Scales of Infant Development, Third Edition (OR 0.32, 95% CI 0.10-0.90, P = .03). There were more women with preeclampsia in the ICC group (37% vs 22%, P = .02) and more women in the DCC group with premature rupture of membranes/preterm labor (54% vs 75%, P = .002). Preeclampsia halved the risk of IVH (OR 0.50, 95% CI 0.2-1.0) and premature rupture of membranes/preterm labor doubled the risk of IVH (OR 2.0, 95% CI 1.2-4.3).
CONCLUSIONS
Although DCC did not alter the incidence of IVH or LOS in preterm infants, it improved motor function at 18-22 months corrected age.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov: NCT00818220 and NCT01426698.",2016,"At 18-22 months, DCC was protective against motor scores below 85 on the Bayley Scales of Infant Development, Third Edition (OR 0.32, 95% CI 0.10-0.90, P = .03).","['Preterm Infants', 'preterm infants', 'Infants in the DCC and ICC groups weighed 1203 ± 352 and 1136 ± 350 g and mean gestational age was 28.3 ± 2 and 28.4 ± 2 weeks, respectively', 'Women (n = 208) in labor with singleton fetuses (<32 weeks gestation']","['ICC', 'delayed cord clamping (DCC) vs immediate cord clamping (ICC', 'Placental Transfusion', 'DCC']","['IVH, LOS, and motor outcomes', 'incidence of IVH or LOS', 'rates of IVH or LOS', 'premature rupture of membranes/preterm labor', 'Preeclampsia halved the risk of IVH', 'preeclampsia', 'motor function', 'intraventricular hemorrhage (IVH), late onset sepsis (LOS), and 18-month motor outcomes', 'premature rupture of membranes/preterm labor doubled the risk of IVH']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0015965', 'cui_str': 'Fetus'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C3698497', 'cui_str': 'Axillary web syndrome'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0022876', 'cui_str': 'Preterm Labor'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]",,0.254662,"At 18-22 months, DCC was protective against motor scores below 85 on the Bayley Scales of Infant Development, Third Edition (OR 0.32, 95% CI 0.10-0.90, P = .03).","[{'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Mercer', 'Affiliation': 'University of Rhode Island, Kingston, RI; Alpert School of Medicine, Brown University, Providence, RI; Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Erickson-Owens', 'Affiliation': 'University of Rhode Island, Kingston, RI; Alpert School of Medicine, Brown University, Providence, RI; Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Alpert School of Medicine, Brown University, Providence, RI; Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Tucker', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'Parker', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Oh', 'Affiliation': 'Alpert School of Medicine, Brown University, Providence, RI; Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Padbury', 'Affiliation': 'Alpert School of Medicine, Brown University, Providence, RI; Women and Infants Hospital of Rhode Island, Providence, RI.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2015.09.068']
807,26490132,"Growth Asymmetry, Head Circumference, and Neurodevelopmental Outcomes in Infants with Single Ventricles.","OBJECTIVE
To assess the variability in asymmetric growth and its association with neurodevelopment in infants with single ventricle (SV).
STUDY DESIGN
We analyzed weight-for-age z-score minus head circumference-for-age z-score (HCAZ), relative head growth (cm/kg), along with individual growth variables in subjects prospectively enrolled in the Infant Single Ventricle Trial. Associations between growth indices and scores on the Psychomotor Developmental Index (PDI) and Mental Developmental Index (MDI) of the Bayley Scales of Infant Development-II (BSID-II) at 14 months were assessed.
RESULTS
Of the 230 subjects enrolled in the Infant Single Ventricle trial, complete growth data and BSID-II scores were available in 168 (73%). Across the cohort, indices of asymmetric growth varied widely at enrollment and before superior cavopulmonary connection (SCPC) surgery. BSID-II scores were not associated with these asymmetry indices. In bivariate analyses, greater pre-SCPC HCAZ correlated with higher MDI (r = 0.21; P = .006) and PDI (r = 0.38; P < .001) and a greater HCAZ increase from enrollment to pre-SCPC with higher PDI (r = 0.15; P = .049). In multivariable modeling, pre-SCPC HCAZ was an independent predictor of PDI (P = .03), but not MDI.
CONCLUSION
In infants with SV, growth asymmetry was not associated with neurodevelopment at 14 months, but pre-SCPC HCAZ was associated with PDI. Asymmetric growth, important in other high-risk infants, is not a brain-sparing adaptation in infants with SV.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT00113087.",2016,"In multivariable modeling, pre-SCPC HCAZ was an independent predictor of PDI (P = .03), but not MDI.
","['infants with single ventricle (SV', '230 subjects enrolled in the Infant Single Ventricle trial', 'Infants with Single Ventricles', 'infants with SV', 'age z-score minus head circumference-for-age z-score (HCAZ), relative head growth (cm/kg), along with individual growth variables in subjects prospectively enrolled in the Infant Single Ventricle Trial']",[],"['Growth Asymmetry, Head Circumference, and Neurodevelopmental Outcomes', 'Psychomotor Developmental Index (PDI) and Mental Developmental Index (MDI) of the Bayley Scales of Infant Development-II (BSID-II', 'complete growth data and BSID-II scores', 'BSID-II scores', 'PDI']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152424', 'cui_str': 'Common ventricle (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",230.0,0.0762964,"In multivariable modeling, pre-SCPC HCAZ was an independent predictor of PDI (P = .03), but not MDI.
","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT. Electronic address: thomas.a.miller@hsc.utah.edu.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Zak', 'Affiliation': 'New England Research Institute, Watertown, MA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Shrader', 'Affiliation': 'New England Research Institute, Watertown, MA.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Shillingford', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institute, Watertown, MA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cnota', 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': 'Department of Surgery, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Sananes', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Richmond', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Daphne T', 'Initials': 'DT', 'LastName': 'Hsu', 'Affiliation': ""Department of Pediatrics, Children's Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY.""}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Miller', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Sinai C', 'Initials': 'SC', 'LastName': 'Zyblewski', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Williams', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2015.09.041']
808,31536957,"Taking opioids in times of crisis: Institutional oversight, chronic pain and suffering in an integrated healthcare delivery system in the U.S.","BACKGROUND
Opioid treatment for chronic pain has garnered heightened public attention and political pressure to control a devastating public health crisis in the United States (U.S.). Resulting policy changes, together with ongoing public and political attention, have pushed health care systems and providers to lower doses or deprescribe and taper patients off opioids. However, little attention has been paid to the impact of such practice changes on patients who had relied on opioid treatment to manage their chronic pain. The aim of this article is to explore experiences with opioid-related care under aggressive tapering efforts and concomitant heightened monitoring and institutional oversight among patients with chronic pain in an integrated delivery system through in-depth interviews.
METHODS
We interviewed 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study. These patients had been prescribed opioids as part of their treatment regimens and taken opioids closely monitored by their health care providers. We followed the framework method for coding and analysing transcripts using NVivo 12.
RESULTS
The experiences of these patients during this period of change can be understood through three interconnected themes: (1) many patients taking opioids experience debilitating physical side effects; (2) navigating opioid treatment contributes to significant emotional distress among many patients with chronic pain and; (3) the quality of patients' relationship with their primary care provider can be negatively affected by negotiations regarding long-term opioid treatment for chronic pain.
CONCLUSION
We highlight the importance of utilizing communication approaches that are patient-centered and include shared decision making during the tapering and/or deprescribing processes of opioids and ensuring alternative pain treatments are available to patients with chronic pain.",2019,We interviewed 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study.,"['patients who had relied on opioid treatment to manage their chronic pain', 'patients had been prescribed opioids as part of their treatment regimens and taken opioids closely monitored by their health care providers', '97 patients with chronic pain who were assigned to the usual care arm of the', 'patients with chronic pain in an integrated delivery system through in-depth interviews', 'patients with chronic pain']",['Pain Program for Active Coping and Training (PPACT'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0282598', 'cui_str': 'Integrated Delivery Systems'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]",[],97.0,0.0297199,We interviewed 97 patients with chronic pain who were assigned to the usual care arm of the Pain Program for Active Coping and Training (PPACT) study.,"[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Gruß', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate, Portland, OR 97227, United States. Electronic address: inga.gruss@kpchr.org.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Firemark', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate, Portland, OR 97227, United States. Electronic address: alison.j.firemark@kpchr.org.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Mayhew', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate, Portland, OR 97227, United States. Electronic address: meghan.h.mayhew@kpchr.org.'}, {'ForeName': 'Carmit K', 'Initials': 'CK', 'LastName': 'McMullen', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate, Portland, OR 97227, United States. Electronic address: carmit.mcmullen@kpchr.org.'}, {'ForeName': 'Lynn L', 'Initials': 'LL', 'LastName': 'DeBar', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Suite 1600, Seattle, WA 98101-1466, United States. Electronic address: lynn.debar@kp.org.'}]",The International journal on drug policy,['10.1016/j.drugpo.2019.08.009']
809,31542446,Impact of customized-consumer medication information on health-related quality of life among patients with type 2 diabetes mellitus.,"BACKGROUND
The importance of providing accurate medication information that can be easily comprehended by patients to subsequently best use their medication(s) has been widely reported in the literature. Patient information leaflet (PIL) is a supporting tool aiding patients to make decisions about their treatment plan and improve patient-clinician communication and thus medication adherence. PIL is the written document produced by the pharmaceutical manufacturers and packed with the medicine. The available PILs do not consider cultural and behavioral perspectives of diverse populations residing in a country like Qatar. Consumer medication information (CMI) is written information about prescription drugs developed by organizations or individuals other than a drug's manufacturer that is intended for distribution to consumers at the time of drug dispensing.
OBJECTIVE
To investigate the impact of customized CMI (C-CMI) on health-related quality of life (HRQoL) among type 2 diabetes mellitus (T2DM) patients in Qatar.
METHODS
This was a randomized controlled intervention study, in which the intervention group patients received C-CMI and the control group patients received usual care. HRQoL was measured using the EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS) at three intervals [i.e. baseline, after 3 months and 6 months].
RESULTS
The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit. There was a statistically significant difference between groups in the HRQoL utility value (represented as EQ index) at 6 months (0.939 vs. 0.796; p = 0.019). Similarly, the intervention group compared with the control group had significantly greater EQ-VAS at 6 months (90% vs. 80%; p = 0.003).
CONCLUSIONS
The impact of C-CMI on health outcomes of T2DM patients in Qatar reported improvement in HRQoL indicators among the intervention patients. The study built a platform for health policymakers and regulatory agencies to consider the provision of C-CMI in multiple languages.",2020,The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit.,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus (T2DM) patients in Qatar']","['customized CMI (C-CMI', 'C-CMI and the control group patients received usual care', 'customized-consumer medication information']","['EQ-5D-5L questionnaire and EQ visual analog scale (EQ-VAS', 'HRQoL', 'health-related quality of life (HRQoL', 'HRQoL indicators', 'health-related quality of life', 'EQ-5D-5L index value', 'HRQoL utility value', 'EQ-VAS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0034366', 'cui_str': 'State of Qatar'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0412891,The EQ-5D-5L index value for the intervention group exhibited sustained improvement from baseline to the third visit.,"[{'ForeName': 'Emad Eldin', 'Initials': 'EE', 'LastName': 'Munsour', 'Affiliation': 'Pharmacy and Drug Control Department, Ministry of Public Health, Doha, Qatar. Electronic address: emadkirra@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Awaisu', 'Affiliation': 'College of Pharmacy, Qatar University, Doha, Qatar.'}, {'ForeName': 'Mohamed Azmi', 'Initials': 'MA', 'LastName': 'Ahmad Hassali', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Doha, Qatar.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Dabbous', 'Affiliation': 'Diabetes/Endocrinology, Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'Noran', 'Initials': 'N', 'LastName': 'Zahran', 'Affiliation': 'College of Pharmacy, Qatar University, Doha, Qatar.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Abdoun', 'Affiliation': 'National Diabetes Center, Hamad Medical Corporation, Doha, Qatar.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.08.038']
810,26545726,Fetal and Neonatal Effects of N-Acetylcysteine When Used for Neuroprotection in Maternal Chorioamnionitis.,"OBJECTIVE
To evaluate the clinical safety of antenatal and postnatal N-acetylcysteine (NAC) as a neuroprotective agent in maternal chorioamnionitis in a randomized, controlled, double-blinded trial.
STUDY DESIGN
Twenty-two mothers >24 weeks gestation presenting within 4 hours of diagnosis of clinical chorioamnionitis were randomized with their 24 infants to NAC or saline treatment. Antenatal NAC (100 mg/kg/dose) or saline was given intravenously every 6 hours until delivery. Postnatally, NAC (12.5-25 mg/kg/dose, n = 12) or saline (n = 12) was given every 12 hours for 5 doses. Doppler studies of fetal umbilical and fetal and infant cerebral blood flow, cranial ultrasounds, echocardiograms, cerebral oxygenation, electroencephalograms, and serum cytokines were evaluated before and after treatment, and 12, 24, and 48 hours after birth. Magnetic resonance spectroscopy and diffusion imaging were performed at term age equivalent. Development was followed for cerebral palsy or autism to 4 years of age.
RESULTS
Cardiovascular measures, cerebral blood flow velocity and vascular resistance, and cerebral oxygenation did not differ between treatment groups. Cerebrovascular coupling was disrupted in infants with chorioamnionitis treated with saline but preserved in infants treated with NAC, suggesting improved vascular regulation in the presence of neuroinflammation. Infants treated with NAC had higher serum anti-inflammatory interleukin-1 receptor antagonist and lower proinflammatory vascular endothelial growth factor over time vs controls. No adverse events related to NAC administration were noted.
CONCLUSIONS
In this cohort of newborns exposed to chorioamnionitis, antenatal and postnatal NAC was safe, preserved cerebrovascular regulation, and increased an anti-inflammatory neuroprotective protein.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT00724594.",2016,Infants treated with NAC had higher serum anti-inflammatory interleukin-1 receptor antagonist and lower proinflammatory vascular endothelial growth factor over time vs controls.,['Twenty-two mothers'],"['antenatal and postnatal N-acetylcysteine (NAC', 'saline', 'N-Acetylcysteine', 'NAC', 'Magnetic resonance spectroscopy and diffusion imaging', 'NAC or saline treatment', 'Antenatal NAC']","['serum anti-inflammatory interleukin-1 receptor antagonist and lower proinflammatory vascular endothelial growth factor', 'fetal umbilical and fetal and infant cerebral blood flow, cranial ultrasounds, echocardiograms, cerebral oxygenation, electroencephalograms, and serum cytokines', 'Cardiovascular measures, cerebral blood flow velocity and vascular resistance, and cerebral oxygenation', 'Cerebrovascular coupling', 'vascular regulation']","[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2317059', 'cui_str': 'Interleukin 1 receptor antagonist product'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0429119', 'cui_str': 'Vascular resistance (observable entity)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]",,0.389926,Infants treated with NAC had higher serum anti-inflammatory interleukin-1 receptor antagonist and lower proinflammatory vascular endothelial growth factor over time vs controls.,"[{'ForeName': 'Dorothea D', 'Initials': 'DD', 'LastName': 'Jenkins', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC. Electronic address: jenkd@musc.edu.'}, {'ForeName': 'Donald B', 'Initials': 'DB', 'LastName': 'Wiest', 'Affiliation': 'Department of Clinical Pharmacy and Outcome Science, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Mulvihill', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Hlavacek', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Majstoravich', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Truman R', 'Initials': 'TR', 'LastName': 'Brown', 'Affiliation': ""Department of Neuroscience's Center for Advanced Imaging Research, Medical University of South Carolina, Charleston, SC.""}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Taylor', 'Affiliation': ""Department of Neuroscience's Center for Advanced Imaging Research, Medical University of South Carolina, Charleston, SC; Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.""}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Buckley', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Turner', 'Affiliation': ""Department of Clinical Pediatrics and Neurology, University of South Carolina School of Medicine and Palmetto Health Richland Children's Hospital, Columbia, SC.""}, {'ForeName': 'Laura Grace', 'Initials': 'LG', 'LastName': 'Rollins', 'Affiliation': 'Department of Clinical Psychology, University of Massachusetts, Boston, MA.'}, {'ForeName': 'Jessica P', 'Initials': 'JP', 'LastName': 'Bentzley', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Hope', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Barbour', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Lowe', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Renee H', 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Eugene Y', 'Initials': 'EY', 'LastName': 'Chang', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2015.09.076']
811,31004217,Correction to: Suspension syndrome: a potentially fatal vagally mediated circulatory collapse-an experimental randomized crossover trial.,The original version of this article unfortunately contained a mistake. Information was missing in the acknowledgements section. The correct information is given below.,2019,The original version of this article unfortunately contained a mistake.,[],['Correction to: Suspension syndrome'],[],[],"[{'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]",[],,0.0253317,The original version of this article unfortunately contained a mistake.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rauch', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy. simon.rauch@eurac.edu.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schenk', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Strapazzon', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Dal Cappello', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gatterer', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Palma', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Erckert', 'Affiliation': 'Department of Cardiology, F. Tappeiner Hospital, 39012, Merano, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Oberhuber', 'Affiliation': 'Department of Internal Medicine I, Gastroenterology, Hepatology, Metabolism and Endocrinology, Medical University Innsbruck, 6020, Innsbruck, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Bliemsrieder', 'Affiliation': 'Department of Anesthesiology, Garmisch-Partenkirchen Medical Center, 82467, Garmisch-Partenkirchen, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brugger', 'Affiliation': 'Institute of Mountain Emergency Medicine, Eurac Research, Viale Druso 1, 39100, Bolzano, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Paal', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Brothers of St. John of God Hospital, Paracelsus Medical University, Kajetanerplatz 1, 5010, Salzburg, Austria.'}]",European journal of applied physiology,['10.1007/s00421-019-04141-6']
812,26500107,Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide.,"OBJECTIVE
To assess whether late surfactant treatment in extremely low gestational age (GA) newborn infants requiring ventilation at 7-14 days, who often have surfactant deficiency and dysfunction, safely improves survival without bronchopulmonary dysplasia (BPD).
STUDY DESIGN
Extremely low GA newborn infants (GA ≤28 0/7 weeks) who required mechanical ventilation at 7-14 days were enrolled in a randomized, masked controlled trial at 25 US centers. All infants received inhaled nitric oxide and either surfactant (calfactant/Infasurf) or sham instillation every 1-3 days to a maximum of 5 doses while intubated. The primary outcome was survival at 36 weeks postmenstrual age (PMA) without BPD, as evaluated by physiological oxygen/flow reduction.
RESULTS
A total of 511 infants were enrolled between January 2010 and September 2013. There were no differences between the treated and control groups in mean birth weight (701 ± 164 g), GA (25.2 ± 1.2 weeks), percentage born at GA <26 weeks (70.6%), race, sex, severity of lung disease at enrollment, or comorbidities of prematurity. Survival without BPD did not differ between the treated and control groups at 36 weeks PMA (31.3% vs 31.7%; relative benefit, 0.98; 95% CI, 0.75-1.28; P = .89) or 40 weeks PMA (58.7% vs 54.1%; relative benefit, 1.08; 95% CI, 0.92-1.27; P = .33). There were no between-group differences in serious adverse events, comorbidities of prematurity, or severity of lung disease to 36 weeks.
CONCLUSION
Late treatment with up to 5 doses of surfactant in ventilated premature infants receiving inhaled nitric oxide was well tolerated, but did not improve survival without BPD at 36 or 40 weeks. Pulmonary and neurodevelopmental assessments are ongoing.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT01022580.",2016,"There were no between-group differences in serious adverse events, comorbidities of prematurity, or severity of lung disease to 36 weeks.
","['extremely low gestational age (GA) newborn infants requiring ventilation at 7-14 days, who often have surfactant deficiency and dysfunction, safely improves survival without bronchopulmonary dysplasia (BPD', 'ventilated premature infants receiving', 'Extremely low GA newborn infants (GA ≤28 0/7 weeks) who required mechanical ventilation at 7-14 days', 'Ventilated Preterm Infants Receiving Inhaled Nitric Oxide', '511 infants were enrolled between January 2010 and September 2013']","['late surfactant treatment', 'Late Surfactant', 'inhaled nitric oxide', 'inhaled nitric oxide and either surfactant (calfactant/Infasurf) or sham instillation']","['serious adverse events, comorbidities of prematurity, or severity of lung disease', 'Survival without BPD', 'survival at 36 weeks postmenstrual age (PMA) without BPD, as evaluated by physiological oxygen/flow reduction', 'survival without BPD', 'mean birth weight']","[{'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0763530', 'cui_str': 'calfactant'}, {'cui': 'C0763529', 'cui_str': 'Infasurf'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0728731', 'cui_str': 'Prematurity of fetus (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]",511.0,0.382269,"There were no between-group differences in serious adverse events, comorbidities of prematurity, or severity of lung disease to 36 weeks.
","[{'ForeName': 'Roberta A', 'Initials': 'RA', 'LastName': 'Ballard', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA. Electronic address: ballardr@peds.ucsf.edu.""}, {'ForeName': 'Roberta L', 'Initials': 'RL', 'LastName': 'Keller', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA.""}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Black', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Philip L', 'Initials': 'PL', 'LastName': 'Ballard', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA.""}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Merrill', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Eichenwald', 'Affiliation': 'Department of Pediatrics, The University of Texas Health Science Center Houston, Houston, TX.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Truog', 'Affiliation': ""Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO.""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Mammel', 'Affiliation': ""Department of Pediatrics, Children's Hospitals and Clinics of Minnesota, St Paul, MN.""}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Pediatrics, UC Davis Children's Hospital, Sacramento, CA.""}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Rogers', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA.""}, {'ForeName': 'Rita M', 'Initials': 'RM', 'LastName': 'Ryan', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Durand', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Asselin', 'Affiliation': ""Department of Pediatrics, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Bendel', 'Affiliation': ""Department of Pediatrics, University of Minnesota Amplatz Children's Hospital, Minneapolis, MN.""}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Bendel-Stenzel', 'Affiliation': ""Department of Pediatrics, Children's Hospitals and Clinics of Minnesota, Minneapolis, MN.""}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': 'Department of Pediatrics, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Ramasubbareddy', 'Initials': 'R', 'LastName': 'Dhanireddy', 'Affiliation': 'Department of Pediatrics, The University of Tennessee Health Science Center, Memphis, TN.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Hudak', 'Affiliation': 'Department of Pediatrics, University of Florida College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Koch', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, WA.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'McKay', 'Affiliation': ""Department of Pediatrics, All Children's Hospital, St Petersburg, FL.""}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Department of Pediatrics, Wake Forest School of Medicine and Forsyth Medical Center, Winston-Salem, NC.'}, {'ForeName': 'Nicolas F', 'Initials': 'NF', 'LastName': 'Porta', 'Affiliation': 'Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Wadhawan', 'Affiliation': 'Department of Pediatrics, Florida Hospital for Children, Orlando, FL.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Palermo', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2015.09.031']
813,32416780,"Atezolizumab with or without chemotherapy in metastatic urothelial cancer (IMvigor130): a multicentre, randomised, placebo-controlled phase 3 trial.","BACKGROUND
Atezolizumab can induce sustained responses in metastatic urothelial carcinoma. We report the results of IMvigor130, a phase 3 trial that compared atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in first-line metastatic urothelial carcinoma.
METHODS
In this multicentre, phase 3, randomised trial, untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries, were randomly assigned to receive atezolizumab plus platinum-based chemotherapy (group A), atezolizumab monotherapy (group B), or placebo plus platinum-based chemotherapy (group C). Patients received 21-day cycles of gemcitabine (1000 mg/m 2 body surface area, administered intravenously on days 1 and 8 of each cycle), plus either carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin (70 mg/m 2 body surface area administered intravenously) on day 1 of each cycle with either atezolizumab (1200 mg administered intravenously on day 1 of each cycle) or placebo. Group B patients received 1200 mg atezolizumab, administered intravenously on day 1 of each 21-day cycle. The co-primary efficacy endpoints for the intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival (group A vs group C) and overall survival (group B vs group C), which was to be formally tested only if overall survival was positive for group A versus group C. The trial is registered with ClinicalTrials.gov, NCT02807636.
FINDINGS
Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients. 451 (37%) were randomly assigned to group A, 362 (30%) to group B, and 400 (33%) to group C. Median follow-up for survival was 11·8 months (IQR 6·1-17·2) for all patients. At the time of final progression-free survival analysis and interim overall survival analysis (May 31, 2019), median progression-free survival in the intention-to-treat population was 8·2 months (95% CI 6·5-8·3) in group A and 6·3 months (6·2-7·0) in group C (stratified hazard ratio [HR] 0·82, 95% CI 0·70-0·96; one-sided p=0·007). Median overall survival was 16·0 months (13·9-18·9) in group A and 13·4 months (12·0-15·2) in group C (0·83, 0·69-1·00; one-sided p=0·027). Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24). Adverse events that led to withdrawal of any agent occurred in 156 (34%) patients in group A, 22 (6%) patients in group B, and 132 (34%) patients in group C. 50 (11%) patients in group A, 21 (6%) patients in group B, and 27 (7%) patients in group C had adverse events that led to discontinuation of atezolizumab or placebo.
INTERPRETATION
Addition of atezolizumab to platinum-based chemotherapy as first-line treatment prolonged progression-free survival in patients with metastatic urothelial carcinoma. The safety profile of the combination was consistent with that observed with the individual agents. These results support the use of atezolizumab plus platinum-based chemotherapy as a potential first-line treatment option for metastatic urothelial carcinoma.
FUNDING
F Hoffmann-La Roche and Genentech.",2020,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","['0·82', 'patients with metastatic urothelial carcinoma', 'Between July 15, 2016, and July 20, 2018, we enrolled 1213 patients', 'metastatic urothelial cancer (IMvigor130', 'first-line metastatic urothelial carcinoma', 'untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries', 'metastatic urothelial carcinoma']","['atezolizumab to platinum-based chemotherapy', 'carboplatin (area under the curve of 4·5 mg/mL per min administered intravenously) or cisplatin', 'Atezolizumab', 'atezolizumab', 'atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy', 'IMvigor130', 'atezolizumab plus platinum-based chemotherapy', 'gemcitabine', 'placebo plus platinum-based chemotherapy', 'Atezolizumab with or without chemotherapy', 'atezolizumab monotherapy', 'placebo']","['Median overall survival', 'median progression-free survival', 'Adverse events', 'overall survival', 'time of final progression-free survival analysis and interim overall survival analysis', 'intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival and overall survival', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",1213.0,0.469836,"Median overall survival was 15·7 months (13·1-17·8) for group B and 13·1 months (11·7-15·1) for group C (1·02, 0·83-1·24).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY, USA. Electronic address: matthew.galsky@mssm.edu.'}, {'ForeName': 'José Ángel Arranz', 'Initials': 'JÁA', 'LastName': 'Arija', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Davis', 'Affiliation': 'Eastern Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De Santis', 'Affiliation': 'Charité University Hospital, Berlin, Germany; Department of Urology, Medical University, Vienna, Austria.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Kikuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Garcia-Del-Muro', 'Affiliation': 'Catalan Institute of Oncology, IDIBELL, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), IRCCS, Meldola, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Mencinger', 'Affiliation': 'Institute of Oncology Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Kanazawa University Hospital, Kanazawa, Japan.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Panni', 'Affiliation': 'Istituti Ospitalieri Cremona, Cremona, Italy.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gumus', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Istanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Arash Rezazadeh', 'Initials': 'AR', 'LastName': 'Kalebasty', 'Affiliation': 'Norton Cancer Institute, Louisville, KY, USA.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Alekseev', 'Affiliation': 'P Herzen Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Schutz', 'Affiliation': 'Beneficencia Portuguesa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jian-Ri', 'Initials': 'JR', 'LastName': 'Li', 'Affiliation': 'Taichung Veterans General Hospital, HungKuang University, Taichung, Taiwan.'}, {'ForeName': 'Dingwei', 'Initials': 'D', 'LastName': 'Ye', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Bernhard', 'Affiliation': 'Roche, Welwyn Garden City, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Tayama', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Almut', 'Initials': 'A', 'LastName': 'Mecke', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'AnnChristine', 'Initials': 'A', 'LastName': 'Thåström', 'Affiliation': 'Genentech, San Francisco, CA, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'MD Anderson Cancer Center Madrid, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30230-0']
814,31551532,Physical activity is associated with functional capacity of older women with osteosarcopenic obesity: 24-month prospective study.,"BACKGROUND/OBJECTIVES
Physical activity (PA) could be effective in the prevention of functional disability in older women, especially for those with body composition abnormalities. The aim this study was to analyze the association of total PA and in different domains with physical function and functional capacity in older women with or without osteosarcopenic obesity (OSO), as well as to assess the risk of functional disability in osteosarcopenic obesity older women insufficiently active.
SUBJECTS/METHODS
The study included 152 Brazilian older women, aged 60 years and older. Body composition was measured by dual energy X-ray absorptiometry (DXA) and physical function by physical tests. Functional capacity and PA were self-reported.
RESULTS
In older women without OSO, the practice of leisure-time exercise (β:-0.23; 95%CI -0.40 to -0.06) and total PA (β:-0.40; 95%CI -0.57 to -0.23) is inversely associated with dependence in ADL. In older women with OSO, the practice of leisure-time exercise was inversely associated with physical function (β:0.88; 95%CI 0.31-1.46) and functional capacity (β:-1.05; 95%CI 1.64 to -0.45), while total PA (β:-1.03; 95%CI -1.93 to -0.13) was inversely associated with functional capacity, independent of control variables. In addition, older women with OSO who remained insufficiently active in leisure-time exercise (HR:2.28; 95%CI 1.04-4.99) and locomotion (HR:2.62; 95%CI 1.28-5.36) domains presented risk for functional disability.
CONCLUSIONS
PA is inversely associated with physical function and functional capacity in older women with or without OSO, and older women with OSO who are insufficiently active in leisure-time exercise and locomotion domains presented a higher risk for functional disability.",2020,"In older women without OSO, the practice of leisure-time exercise (β:-0.23; 95%CI -0.40 to -0.06) and total PA (β:-0.40; 95%CI -0.57 to -0.23) is inversely associated with dependence in ADL.","['older women with or without OSO, and older women with OSO', '152 Brazilian older women, aged 60 years and older', 'older women with OSO', 'older women with or without osteosarcopenic obesity (OSO', 'older women', 'osteosarcopenic obesity older women insufficiently active', 'older women with osteosarcopenic obesity']",['Physical activity (PA'],"['physical function', 'Body composition', 'functional capacity', 'physical function and functional capacity', 'total PA']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0860006,"In older women without OSO, the practice of leisure-time exercise (β:-0.23; 95%CI -0.40 to -0.06) and total PA (β:-0.40; 95%CI -0.57 to -0.23) is inversely associated with dependence in ADL.","[{'ForeName': 'Vanessa Ribeiro', 'Initials': 'VR', 'LastName': 'Dos Santos', 'Affiliation': 'Skeletal Muscle Assessment Laboratory, LABSIM, Department of Physical Education, School of Technology and Sciences, São Paulo State University, UNESP, Presidente Prudente, Sao Paulo, Brazil.'}, {'ForeName': 'Luís Alberto', 'Initials': 'LA', 'LastName': 'Gobbo', 'Affiliation': 'Skeletal Muscle Assessment Laboratory, LABSIM, Department of Physical Education, School of Technology and Sciences, São Paulo State University, UNESP, Presidente Prudente, Sao Paulo, Brazil. luis.gobbo@unesp.br.'}]",European journal of clinical nutrition,['10.1038/s41430-019-0505-y']
815,31822548,Randomised controlled trial comparing hydroxyapatite coated uncemented hemiarthroplasty with cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures: a protocol for the WHITE 5 study.,"INTRODUCTION
Hip fracture is a serious injury in adults, especially those aged over 60 years. The most common type of hip fracture (displaced intracapsular) is treated for the majority of patients with a partial hip replacement (hemiarthroplasty). The hemiarthroplasty implant can be fixed to the bone with or without bone cement. Cement is the current recommended technique but recently some risks have been identified, which could potentially be avoided by using uncemented implants. Controversy, therefore, remains about which type of hemiarthroplasty offers patients the best outcomes.This is the protocol for a multicentre randomised controlled trial comparing cemented hemiarthroplasty versus uncemented hemiarthroplasty for patients 60 years and over with a displaced intracapsular hip fracture.
METHODS AND ANALYSIS
Multicentre (a minimum of seven UK hospitals), multisurgeon, parallel group, two-arm, superiority, randomised controlled trial. Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either a cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty. Otherwise all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: health-related quality of life (EuroQol 5 dimensions 5 levels) at 4 months postinjury. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. Secondary outcomes include mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12 months and health resource use. A within-trial economic analysis will be conducted.
ETHICS, DISSEMINATION AND FUNDING
Wales Research Ethics Committee 5 approved the feasibility phase on 2 December 2016 (16/WA/0351) and the definitive trial on 22 November 2017 (17/WA/0383). This study is sponsored by the University of Oxford and funded by the National Institute for Health Research, Research for Patient Benefit (PB-PG-0215-36043 and PB-PG-1216-20021). A manuscript for a peer-reviewed journal will be prepared and the results shared with patients via local mechanisms at participating centres.
TRIAL REGISTRATION NUMBER
ISRCTN18393176.",2019,Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible.,"['adults, especially those aged over 60 years', 'displaced intracapsular hip fractures', 'patients 60 years and over with a displaced intracapsular hip fracture', 'patients with a partial hip replacement (hemiarthroplasty', '1128 patients', 'Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible']","['hydroxyapatite coated uncemented hemiarthroplasty with cemented hemiarthroplasty', 'cemented hemiarthroplasty versus uncemented hemiarthroplasty', 'cemented hemiarthroplasty or a modern hydroxyapatite coated uncemented hemiarthroplasty']","['mortality, complications including revision surgery and cause, mobility status, residential status, health-related quality of life at 1 and 12\u2009months and health resource use']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0392806', 'cui_str': 'Hip Prosthesis Implantation'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0115137', 'cui_str': 'Durapatite'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",1128.0,0.185581,Patients aged 60 years and older with a displaced intracapsular hip fracture treated with hemiarthroplasty surgery are eligible.,"[{'ForeName': 'Miguel Antonio', 'Initials': 'MA', 'LastName': 'Fernandez', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robin Gillmore', 'Initials': 'RG', 'LastName': 'Lerner', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Mironov', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trial Unit, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'May E', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Oxford Clinical Trial Unit, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alwin', 'Initials': 'A', 'LastName': 'McGibbon', 'Affiliation': 'Patient Representative, London, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gould', 'Affiliation': 'Patient Representative, London, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Griffin', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, NDORMS, University of Oxford, Oxford, UK matthew.costa@ndorms.ox.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-033957']
816,24754379,"A multicentre, randomized, placebo-controlled trial establishing the treatment effect of TDT 068, a topical formulation containing drug-free ultra-deformable phospholipid vesicles, on the primary features of erythematotelangiectatic rosacea.","BACKGROUND
Rosacea subtype 1 (erythematotelangiectatic) is an inflammatory skin disease with limited treatment options. TDT 068, a topical drug-free gel containing ultra-deformable Sequessome vesicles, is registered for use in inflammatory skin conditions, but has not been investigated in rosacea.
OBJECTIVE
This postmarketing study aimed to substantiate the effects of TDT 068 in rosacea subtype 1.
METHODS
Patients aged 18-85 scoring 6-15/30 for the primary and secondary features of the rosacea standard grading system (RSGS) were enrolled. Following stratification (four females/one male) patients were randomized (2:1) to receive TDT 068 or vehicle gel for 4 weeks. Efficacy was evaluated using the patient-rated rosacea-specific quality of life (R-QOL) instrument and investigator-rated RSGS. Adverse events (AEs) were monitored throughout.
RESULTS
Of the 61 randomized patients, 58 were eligible for the full analysis set per protocol. Baseline characteristics were balanced across the groups. R-QOL symptom construct scores improved slightly from baseline to Week 4 in both groups (-0.04 ± 0.51 TDT 068 vs. -0.22 ± 0.59 vehicle; P = 0.1990). Changes in R-QOL total, function and emotion construct scores at Week 4 were similar with TDT 068 and vehicle, but TDT 068 yielded numerically greater increases in total RSGS scores (-1.55 ± 1.83 vs. -0.75 ± 2.38 vehicle; P = 0.105). Non-transient erythema improved significantly with TDT 068 at Week 4 (-0.34 ± 0.63 vs. -0.05 ± 0.51 vehicle; P = 0.044), with ≥1 grade improvement in 35% of patients (vs. 15% vehicle; P = 0.039). Numerically greater improvements in transient erythema and telangiectasia were also seen with TDT 068. Three treatment-related AEs were reported but no serious AEs occurred.
CONCLUSION
These data, based on investigator assessment, provide evidence for the good tolerability of drug-free TDT 068 as well as modest improvements in the symptoms of erythematotelangiectatic rosacea.",2015,"Changes in R-QOL total, function and emotion construct scores at Week 4 were similar with TDT 068 and vehicle, but TDT 068 yielded numerically greater increases in total RSGS scores (-1.55 ± 1.83 vs. -0.75 ± 2.38 vehicle; P = 0.105).","['Of the 61 randomized patients, 58 were eligible for the full analysis set per protocol', 'Patients aged 18-85 scoring 6-15/30 for the primary and secondary features of the rosacea standard grading system (RSGS) were enrolled', 'Following stratification (four females/one male) patients', '068 in rosacea subtype 1']","['TDT 068 or vehicle gel', 'placebo', 'TDT']","['R-QOL symptom construct scores', 'Efficacy', 'total RSGS scores', 'patient-rated rosacea-specific quality of life (R-QOL) instrument and investigator-rated RSGS', 'transient erythema and telangiectasia', 'Adverse events (AEs', 'Non-transient erythema', 'Changes in R-QOL total, function and emotion construct scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0449560', 'cui_str': 'Subtype (attribute)'}]","[{'cui': 'C4079022', 'cui_str': 'TDT 068'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",4.0,0.589063,"Changes in R-QOL total, function and emotion construct scores at Week 4 were similar with TDT 068 and vehicle, but TDT 068 yielded numerically greater increases in total RSGS scores (-1.55 ± 1.83 vs. -0.75 ± 2.38 vehicle; P = 0.105).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Luger', 'Affiliation': 'Department of Dermatology, University Clinics, Münster, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Peukert', 'Affiliation': 'Dermatology, Aestheso, Münster, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rother', 'Affiliation': 'IMR Partner GmbH, Munich, Germany.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.12520']
817,32424935,Liraglutide treatment in overweight and obese patients with type 1 diabetes: A 26-week randomized controlled trial; mechanisms of weight loss.,"AIM
To investigate the effects of liraglutide treatment on glycaemic control and adipose tissue metabolism in overweight and obese people with type 1 diabetes (T1DM).
RESEARCH DESIGN AND METHODS
A total of 84 adult overweight and obese patients with T1DM, with no detectable C-peptide, were randomized (1:1) to either placebo or 1.8 mg/d liraglutide for 6 months. Blood samples were collected at 0, 12 and 26 weeks. Subcutaneous adipose tissue biopsies, a high-calorie high-fat meal challenge test, continuous glucose monitoring, dual-energy X-ray absorptiometry and MRI were performed before and at the end of treatment.
RESULTS
In all, 37 and 27 patients who received liraglutide and placebo, respectively, completed the study. Glycated haemoglobin fell by 0.41 ± 0.18% (4.5±1.4 mmol/mol) from baseline after liraglutide treatment (P = 0.001), and by 0.29 ± 0.19% (3.1±2.0 mmol/mol) compared to placebo (P = 0.1). There was no increase in hypoglycaemia, while the time spent in normal glycaemia increased (P = 0.015) and time spent in hyperglycaemia decreased (P = 0.019). Body weight fell significantly in the liraglutide group, mostly in the form of fat mass loss (including visceral fat), with no change in lean mass. Systolic blood pressure (SBP) also fell after liraglutide treatment. Liraglutide also caused a significant increase in the expression of adipose tissue triglyceride lipase, carnitine palmitoyl transferase-1, peroxisome proliferator-activated receptor (PPAR)α, PPARδ, uncoupling protein-2 and type 2 iodothyronine deiodinase in the adipose tissue.
CONCLUSIONS
Liraglutide improves glycaemia, reduces adiposity and SBP. Liraglutide also stimulates mechanisms involved with an increase in lipid oxidation and thermogenesis, while conserving lean body mass.",2020,There was no increase in hypoglycemia while the time spent in normal glycemia increased (p = 0.015) and time spent in hyperglycemia decreased (p = 0.019).,"['adult overweight and obese', 'overweight and obese T1DM patients', '37 and 27 patients who received', 'patients with type 1 diabetes (T1DM', 'Overweight and Obese Patients with Type 1 Diabetes', '84']","['liraglutide', 'Liraglutide', 'liraglutide or placebo', 'Subcutaneous adipose tissue biopsies, high calorie high fat (HCHF) meal, CGM, DEXA', 'placebo']","['time spent in hyperglycemia', 'expression of ATGL, CPT-1, PPARα, PPARδ, UCP-2 and Dio-2 in the adipose tissue', 'lipid oxidation and thermogenesis', 'Blood samples', 'glycemic control, weight loss', 'hypoglycemia while the time spent in normal glycemia', 'Body weight', 'glycemic control and adipose tissue metabolism', 'systolic blood pressure (SBP', 'glycemia, reduces adiposity and SBP', 'SBP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007262', 'cui_str': 'Carnitine palmitoyltransferase'}, {'cui': 'C0854076', 'cui_str': 'Distal ileal obstruction syndrome'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",84.0,0.0906694,There was no increase in hypoglycemia while the time spent in normal glycemia increased (p = 0.015) and time spent in hyperglycemia decreased (p = 0.019).,"[{'ForeName': 'Husam', 'Initials': 'H', 'LastName': 'Ghanim', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Manav', 'Initials': 'M', 'LastName': 'Batra', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Green', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Sanaa', 'Initials': 'S', 'LastName': 'Abuaysheh', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Hejna', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Antione', 'Initials': 'A', 'LastName': 'Makdissi', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Borowski', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Nitesh D', 'Initials': 'ND', 'LastName': 'Kuhadiya', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chaudhuri', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo, Buffalo, 14221, New york, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14090']
818,25197610,Effect of simvastatin and atorvastatin on serum vitamin d and bone mineral density in hypercholesterolemic patients: a cross-sectional study.,"Background. Besides lipid-lowering effect of statins, they have been shown to have nonlipid lowering effects, such as improving bone health. An improvement in bone mineral density (BMD) has been indicated in some studies after the use of statins, in addition to an increase in 25-hydroxyvitamin D (25OHD) level. The aim of this study is to explore the association between statins and bone health taking into consideration 25OHD level and BMD. Methods. This is a randomized, cross-sectional comparative study. Subjects were divided into two groups, hypercholesterolemic participants taking simvastatin or atorvastatin as the study group and a matched control group not taking statins. All participants were assessed for serum 25OHD and BMD at lumbar spine and femoral neck. Results. A total of 114 participants were included in the study, 57 participants in each group. Results of serum 25OHD showed no significant difference between study and control groups (P = 0.47), while BMD results of lumbar spine and femoral neck showed significant difference (P = 0.05 and 0.03, resp.). Conclusion. Simvastatin and atorvastatin, at any dose for duration of more than one year, have no additive effect on 25OHD level but have a positive effect on the BMD.",2014,"Results of serum 25OHD showed no significant difference between study and control groups (P = 0.47), while BMD results of lumbar spine and femoral neck showed significant difference (P = 0.05 and 0.03, resp.).","['hypercholesterolemic patients', 'A total of 114 participants were included in the study, 57 participants in each group']","['control group not taking statins', 'simvastatin and atorvastatin', 'hypercholesterolemic participants taking simvastatin or atorvastatin', 'Simvastatin and atorvastatin']","['BMD results of lumbar spine and femoral neck', 'serum 25OHD', 'bone mineral density (BMD', '25OHD level', '25-hydroxyvitamin D (25OHD) level', 'serum 25OHD and BMD at lumbar spine and femoral neck', 'serum vitamin d and bone mineral density']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]",114.0,0.0369496,"Results of serum 25OHD showed no significant difference between study and control groups (P = 0.47), while BMD results of lumbar spine and femoral neck showed significant difference (P = 0.05 and 0.03, resp.).","[{'ForeName': 'Abrar', 'Initials': 'A', 'LastName': 'Thabit', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, King Abdulaziz University, Jeddah 22254, Saudi Arabia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alhifany', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Umm Al-Qura University, Makkah 24243, Saudi Arabia.'}, {'ForeName': 'Razan', 'Initials': 'R', 'LastName': 'Alsheikh', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, King Abdulaziz University, Jeddah 22254, Saudi Arabia.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Namnqani', 'Affiliation': 'King Abdullah Medical City, Makkah 24246, Saudi Arabia.'}, {'ForeName': 'Ameen', 'Initials': 'A', 'LastName': 'Al-Mohammadi', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, King Abdulaziz University, Jeddah 22254, Saudi Arabia.'}, {'ForeName': 'Soha', 'Initials': 'S', 'LastName': 'Elmorsy', 'Affiliation': 'King Abdullah Medical City, Makkah 24246, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Qari', 'Affiliation': 'Center of Excellence for Osteoporosis Research, King Abdulaziz University, Jeddah 22254, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Ardawi', 'Affiliation': 'Center of Excellence for Osteoporosis Research, King Abdulaziz University, Jeddah 22254, Saudi Arabia.'}]",Journal of osteoporosis,['10.1155/2014/468397']
819,31821750,"Evaluation of Clinical Cardiac Safety of Itacitinib, a JAK1 Inhibitor, in Healthy Participants.","Itacitinib is a JAK1-selective inhibitor in phase 3 development in graft-versus-host disease. A post hoc electrocardiogram (ECG) analysis and a plasma concentration-QTc (C-QTc) analysis were performed to assess cardiac safety using data from the first-in-human itacitinib study. The study included 2 cohorts of 12 healthy participants each in an interleaving dosing design with single doses of 10-300 mg or placebo; 500 and 1000 mg doses were subsequently added with 12 participants randomized to itacitinib or placebo. Continuous Holter recordings were collected from 1 hour predose to 8 hours postdose on each dosing day, and ECG intervals were blindly extracted to match timed pharmacokinetic samples. Data showed no hysteresis, and a prespecified linear mixed-effects C-QTc model was used with change-from-baseline QTcF (QT interval corrected for heart rate by Fridericia's method) as the dependent variable, plasma itacitinib concentrations and centered baseline QTcF as continuous covariates, treatment and time as categorical factors, and a random intercept per participant. The estimated slope of the C-QTc relationship was not significantly different from zero: 0.0002 milliseconds per nM (90%CI, -0.00019 to 0.00054 milliseconds). No clinically meaningful effects on cardiac conduction (PR and QRS intervals) or any categorical PR or QRS outliers were observed. A QTc effect exceeding the threshold of concern (10 milliseconds) can be excluded for itacitinib plasma concentrations up to ∼13 000 nM (∼7200 ng/mL), which is well above the maximum concentration expected with the highest proposed therapeutic dose of itacitinib either with concomitant use of cytochrome P450 3A4 inhibitors or in patients with impaired hepatic function.",2020,No clinically meaningful effects on cardiac conduction (PR and QRS intervals) or any categorical PR or QRS outliers were observed.,"['patients with impaired hepatic function', '12 healthy participants each in an interleaving dosing design with single doses of 10-300 mg or', 'Healthy Participants']","['Itacitinib, a JAK1 Inhibitor', 'placebo', 'itacitinib or placebo']","['estimated slope of the C-QTc relationship', 'plasma concentration-QTc (C-QTc) analysis', 'cardiac conduction (PR and QRS intervals) or any categorical PR or QRS outliers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction (observable entity)'}, {'cui': 'C0520880', 'cui_str': 'QRS interval'}]",,0.157254,No clinically meaningful effects on cardiac conduction (PR and QRS intervals) or any categorical PR or QRS outliers were observed.,"[{'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Incyte Research Institute, Wilmington, Delaware, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'eRT/iCardiac Technologies, Rochester, New York, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'eRT/iCardiac Technologies, Rochester, New York, USA.'}, {'ForeName': 'Naresh', 'Initials': 'N', 'LastName': 'Punwani', 'Affiliation': 'Incyte Research Institute, Wilmington, Delaware, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware, USA.'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Barbour', 'Affiliation': 'Incyte Research Institute, Wilmington, Delaware, USA.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Epstein', 'Affiliation': 'Incyte Research Institute, Wilmington, Delaware, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Landman', 'Affiliation': 'Incyte Research Institute, Wilmington, Delaware, USA.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Incyte Research Institute, Wilmington, Delaware, USA.'}, {'ForeName': 'Swamy', 'Initials': 'S', 'LastName': 'Yeleswaram', 'Affiliation': 'Incyte Research Institute, Wilmington, Delaware, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.758']
820,31248346,Factors Predicting Intent to Intervene with a Potentially Suicidal Peer.,"The current study examined how the theory of planned behavior (TPB) constructs predict college students' intent to ask about suicide and refer a potentially suicidal peer to support. Using an experimental design, 420 college students (M age = 19.61, SD = 1.50 yrs) were randomly assigned to read one of four vignettes depicting a peer in distress that varied suicide risk severity (low vs. high) and perceived causes of the distress (internal vs. external). Participants read their vignette and answered questions measuring TPB constructs and items assessing intent to ask about suicide and intent to refer the peer to services. Results indicated that subjective norms were associated with intent to ask about suicide and attitudes impact intent to refer. Only the interaction between risk severity and perceived behavioral control in predicting intent to refer and intent to ask were significant. Peers who perceive risk to be high are more likely to refer peers regardless of perceived behavioral control and are increasingly more likely to ask about suicide as perceived behavioral control increases. When risk severity is low and perceived behavioral control is low, peers are less likely to refer or ask about suicide. The theory of planned behavior has relevance to understanding peer intent to intervene with an at-risk peer and may be beneficial to guiding the development of effective suicide prevention programs.",2020,Only the interaction between risk severity and perceived behavioral control in predicting intent to refer and intent to ask were significant.,"['420 college students ( M age = 19.61, SD \u2009=\u20091.50yrs']",['planned behavior (TPB'],[],"[{'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],420.0,0.0163857,Only the interaction between risk severity and perceived behavioral control in predicting intent to refer and intent to ask were significant.,"[{'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Muehlenkamp', 'Affiliation': ''}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Hagan', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2019.1635933']
821,24754529,Photodynamic therapy vs. imiquimod 5% cream as skin cancer preventive strategies in patients with field changes: a randomized intraindividual comparison study.,"BACKGROUND
Actinic damage is responsible for the development of multiple, recurrent non-melanoma skin cancers (NMSCs), including actinic keratoses (AKs). Photodynamic therapy (PDT) and imiquimod cream (IMIQ) 5% are recommended as field-directed treatment options.
OBJECTIVES
To compare efficacy and safety of methyl aminolevulinate (MAL)-PDT vs. IMIQ 5% in the prevention of new NMSCs development patients with field changes.
METHODS
Patients with field cancerization of the face or scalp were randomized to receive MAL-PDT on one side, and IMIQ 5% on the mirror field. The primary endpoint was the number of new lesions on the treated fields during a 12-month follow-up period. Secondary assessments included adverse events and patient preference.
RESULTS
Forty-four patients completed the study. MAL-PDT and IMIQ did not differ concerning the primary endpoint, as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up. Both treatment regimens were safe and well tolerated. Patients' preference based on the procedure, response rates and future choice favoured MAL-PDT.
CONCLUSIONS
MAL-PDT and IMIQ 5% are safe and well-tolerated treatments that equally prevent development of new AKs in patients suffering from field changes. MAL-PDT treatment appears to be superior in terms of patients' preference.",2015,"MAL-PDT and IMIQ did not differ concerning the primary endpoint, as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up.","['patients with field changes', 'new NMSCs development patients with field changes', 'Forty-four patients completed the study', 'patients suffering from field changes', 'Patients with field cancerization of the face or scalp']","['MAL-PDT', 'methyl aminolevulinate (MAL)-PDT vs. IMIQ', 'Photodynamic therapy vs. imiquimod 5% cream', 'Photodynamic therapy (PDT) and imiquimod cream (IMIQ']","['development of new NMSCs', 'adverse events and patient preference', 'safe and well tolerated', 'MAL-PDT and IMIQ', 'number of new lesions on the treated fields']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}]","[{'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C1134467', 'cui_str': 'methyl aminolevulinate'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0165032', 'cui_str': 'imiquimod'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0440042', 'cui_str': ""Field's""}]",44.0,0.025916,"MAL-PDT and IMIQ did not differ concerning the primary endpoint, as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sotiriou', 'Affiliation': 'First Dermatology Department, Medical Schoool, Aristotle University Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Apalla', 'Affiliation': 'First Dermatology Department, Medical Schoool, Aristotle University Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vrani', 'Affiliation': 'First Dermatology Department, Medical Schoool, Aristotle University Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lallas', 'Affiliation': 'First Dermatology Department, Medical Schoool, Aristotle University Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chovarda', 'Affiliation': 'First Dermatology Department, Medical Schoool, Aristotle University Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ioannides', 'Affiliation': 'First Dermatology Department, Medical Schoool, Aristotle University Thessaloniki, Thessaloniki, Greece.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.12538']
822,31740103,Does Activity-Based Rehabilitation With Goal Attainment Scaling Increase Physical Activity Among Younger Knee Arthroplasty Patients? Results From the Randomized Controlled ACTION Trial.,"BACKGROUND
Especially in younger knee osteoarthritis patients, the ability to perform physical activity (PA) after knee arthroplasty (KA) is of paramount importance, given many patients' wish to return to work and perform demanding leisure time activities. Goal Attainment Scaling (GAS) rehabilitation after KA may improve PA because it uses individualized activity goals. Therefore, our aim was to objectively quantify PA changes after KA and to compare GAS-based rehabilitation to standard rehabilitation.
METHODS
Data were obtained from the randomized controlled ACTION trial, which compares standard rehabilitation with GAS-based rehabilitation after total and unicompartmental KA in patients <65 years of age. At 2 time points, preoperatively and 6 months postoperatively, 120 KA patients wore a validated 3-dimensional accelerometer for 1 consecutive week. Data were classified as sedentary (lying, sitting), standing, and active (walking, cycling, running). Repeated measures analysis of variance was used to compare PA changes over time.
RESULTS
Complete data were obtained for 97 patients (58% female), with a mean age of 58 years (±4.8). For the total group, we observed a significant increase in PA of 9 minutes (±37) per day (P = .01) and significant decrease in sedentary time of 20 minutes (±79) per day (P = .02). There was no difference in standing time (P = .11). There was no difference between the control group and the intervention group regarding changes in PA, nor between the total KA group and the unicompartmental KA group.
CONCLUSION
We found a small but significant increase in overall PA after KA, but no difference between GAS-based rehabilitation and standard rehabilitation. Likely, enhanced multidisciplinary perioperative strategies are needed to further improve PA after KA.",2020,"There was no difference between the control group and the intervention group regarding changes in PA, nor between the total KA group and the unicompartmental KA group.
","['patients <65 years of age', 'younger knee osteoarthritis patients', 'Younger Knee Arthroplasty Patients', '97 patients (58% female), with a mean age of 58 years (±4.8']",['standard rehabilitation with GAS-based rehabilitation after total and unicompartmental KA'],"['overall PA', 'PA', 'standing time', 'sedentary time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]",,0.0481427,"There was no difference between the control group and the intervention group regarding changes in PA, nor between the total KA group and the unicompartmental KA group.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hoorntje', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands; Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Witjes', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands; Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands; ICONE Orthopaedics and Sports Traumatology, Schijndel, the Netherlands.'}, {'ForeName': 'P Paul F M', 'Initials': 'PPFM', 'LastName': 'Kuijer', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes B J', 'Initials': 'JBJ', 'LastName': 'Bussmann', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Herwin L D', 'Initials': 'HLD', 'LastName': 'Horemans', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutger C I', 'Initials': 'RCI', 'LastName': 'van Geenen', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Koen L M', 'Initials': 'KLM', 'LastName': 'Koenraadt', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.10.028']
823,31322915,Pelvic side wall recurrence in locally advanced cervical carcinoma treated with definitive chemoradiation-clinical impact of pelvic wall dose.,"OBJECTIVE
Pelvic side wall dose in locally advanced cervical carcinoma treated with definitive chemoradiation has been debated. The present study investigated relationship of disease recurrence with dose for the pelvic side wall. It also attempted to identify minimal dose that significantly reduced recurrence.
METHODS
Pelvic side wall recurrence at median 24 months was assessed clinically and radiologically across three groups of patients receiving variable pelvic wall doses using no parametrial boost, external beam or interstitial boost, or dose escalated combined external beam with interstitial boost.
RESULTS
At 24 months, recurrence occurred in 3/155 boost vs 40/130 no boost patients. ( p < 0.0001). Receiver operating characteristic curve analysis demonstrated cut-off pelvic wall dose to be 58.9 Gy ( p < 0.0001). Dose escalated combined boost showed no significant benefit compared to single modality parametrial boost ( p = 0. 0.553).
CONCLUSION
Mean pelvic wall dose of at least 58.9 Gy offers clinically significant benefit in pelvic wall control. Doses recommended by guidelines should be adhered to in the patients' best interests.
ADVANCES IN KNOWLEDGE
This preliminary study determined a relationship between recurrence rates and dose to the pelvic side wall and also a cut-off dose that significantly improved pelvic wall control in locally advanced cervical cancer.",2019,"Dose escalated combined boost showed no significant benefit compared to single modality parametrial boost ( p = 0. 0.553).
","['locally advanced cervical cancer', 'locally advanced cervical carcinoma', 'locally advanced cervical carcinoma treated with']","['variable pelvic wall doses using no parametrial boost, external beam or interstitial boost, or dose escalated combined external beam with interstitial boost', 'definitive chemoradiation']","['recurrence', 'Pelvic side wall recurrence']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0302592', 'cui_str': 'Carcinoma of cervix (disorder)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0230284', 'cui_str': 'Pelvic wall structure'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}]",,0.0366019,"Dose escalated combined boost showed no significant benefit compared to single modality parametrial boost ( p = 0. 0.553).
","[{'ForeName': 'Aparna', 'Initials': 'A', 'LastName': 'Gangopadhyay', 'Affiliation': 'Department of Radiotherapy, Chittaranjan National Cancer Institute, 37 S.P. Mukherjee Road, Kolkata, India.'}, {'ForeName': 'Subrata', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Department of Radiotherapy, Medical College Hospitals, Kolkata 88, College Street, Kolkata, India.'}]",The British journal of radiology,['10.1259/bjr.20180841']
824,23572217,Characterizing the learning curve of the VBLaST-PT(©) (Virtual Basic Laparoscopic Skill Trainer).,"BACKGROUND
Mastering laparoscopic surgical skills requires considerable time and effort. The Virtual Basic Laparoscopic Skill Trainer (VBLaST-PT(©)) is being developed as a computerized version of the peg transfer task of the Fundamentals of Laparoscopic Surgery (FLS) system using virtual reality technology. We assessed the learning curve of trainees on the VBLaST-PT(©) using the cumulative summation (CUSUM) method and compared them with those on the FLS to establish convergent validity for the VBLaST-PT(©).
METHODS
Eighteen medical students from were assigned randomly to one of three groups: control, VBLaST-training, and FLS-training. The VBLaST and the FLS groups performed a total of 150 trials of the peg-transfer task over a 3-week period, 5 days a week. Their CUSUM scores were computed based on predefined performance criteria (junior, intermediate, and senior levels).
RESULTS
Of the six subjects in the VBLaST-training group, five achieved at least the ""junior"" level, three achieved the ""intermediate"" level, and one achieved the ""senior"" level of performance criterion by the end of the 150 trials. In comparison, for the FLS group, three students achieved the ""senior"" criterion and all six students achieved the ""intermediate"" and ""junior"" criteria by the 150th trials. Both the VBLaST-PT(©) and the FLS systems showed significant skill improvement and retention, albeit with system specificity as measured by transfer of learning in the retention test: The VBLaST-trained group performed better on the VBLaST-PT(©) than on FLS (p = 0.003), whereas the FLS-trained group performed better on the FLS than on VBLaST-PT(©) (p = 0.002).
CONCLUSIONS
We characterized the learning curve for a virtual peg transfer task on the VBLaST-PT(©) and compared it with the FLS using CUSUM analysis. Subjects in both training groups showed significant improvement in skill performance, but the transfer of training between systems was not significant.",2013,The Virtual Basic Laparoscopic Skill Trainer (VBLaST-PT(©)) is being developed as a computerized version of the peg transfer task of the Fundamentals of Laparoscopic Surgery (FLS) system using virtual reality technology.,['Eighteen medical students'],"['FLS', 'VBLaST', 'Virtual Basic Laparoscopic Skill Trainer (VBLaST-PT(©', 'control, VBLaST-training, and FLS-training']","['junior"" level', 'skill performance', 'intermediate"" level']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]",18.0,0.0160587,The Virtual Basic Laparoscopic Skill Trainer (VBLaST-PT(©)) is being developed as a computerized version of the peg transfer task of the Fundamentals of Laparoscopic Surgery (FLS) system using virtual reality technology.,"[{'ForeName': 'Likun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Mechanical Engineering, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Sankaranarayanan', 'Affiliation': ''}, {'ForeName': 'Venkata Sreekanth', 'Initials': 'VS', 'LastName': 'Arikatla', 'Affiliation': ''}, {'ForeName': 'Woojin', 'Initials': 'W', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Cristol', 'Initials': 'C', 'LastName': 'Grosdemouge', 'Affiliation': ''}, {'ForeName': 'Jesse M', 'Initials': 'JM', 'LastName': 'Rideout', 'Affiliation': ''}, {'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'Epstein', 'Affiliation': ''}, {'ForeName': 'Suvranu', 'Initials': 'S', 'LastName': 'De', 'Affiliation': ''}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Schwaitzberg', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Caroline G L', 'Initials': 'CG', 'LastName': 'Cao', 'Affiliation': ''}]",Surgical endoscopy,['10.1007/s00464-013-2932-5']
825,24135768,Effect of isoniazid therapy for latent TB infection on QuantiFERON-TB gold in-tube responses in adults with positive tuberculin skin test results in a high TB incidence area: a controlled study.,"BACKGROUND
T-cell interferon-γ release assays (IGRAs) are used in the diagnosis of Mycobacterium tuberculosis infection and could be useful biomarkers of response to treatment of latent TB infection for clinical trials, infection control units, and TB programs.
METHODS
This investigation was a prospective, controlled substudy of IGRA responses in 82 healthy South African adults with HIV seronegative and positive tuberculin skin test results randomly assigned to treatment with 6 months of daily isoniazid preventive therapy (IPT) or observation before Bacillus Calmette-Guérin revaccination in a clinical trial. QuantiFERON-TB Gold In-Tube (QFT-GIT) assay was used to measure interferon-γ (IFN-γ) response to mycobacterial antigens at baseline and after IPT or observation.
RESULTS
IFN-γ levels declined between baseline and the end of IPT (signed rank test P≤.0001) and between baseline and a similar period of observation without IPT (signed rank test P=.03). The rate of decrease in IFN-γ responses over time did not differ between the groups (Mann-Whitney-Wilcoxon test P=.31). QFT-GIT test results in two subjects (5%) in the IPT group and two subjects (5%) in the observation group reverted from positive to negative during follow-up. No significant difference was found between the groups with respect to baseline positivity or the proportion of patients whose tests reverted to negative.
CONCLUSIONS
IPT had no effect on changes in QFT-GIT readouts during short-term follow-up of adults with positive tuberculin skin tests in a high TB incidence setting. QFT-GIT is unlikely to be a useful biomarker of response to treatment of latent TB infection.
TRIAL REGISTRY
ClinicalTrials.gov; No.: NCT01119521; URL: www.clinicaltrials.gov.",2014,"RESULTS
IFN-γ levels declined between baseline and the end of IPT (signed rank test P≤.0001) and between baseline and a similar period of observation without IPT (signed rank test P=.03).","['adults with positive tuberculin skin test', '82 healthy South African adults with HIV seronegative and positive tuberculin skin test']","['isoniazid preventive therapy (IPT) or observation before Bacillus Calmette-Guérin revaccination', 'isoniazid therapy', 'IPT', 'QuantiFERON-TB Gold', 'T-cell interferon-γ release assays (IGRAs']","['IFN-γ levels', 'IFN-γ responses', 'QFT-GIT readouts']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041289', 'cui_str': 'Tuberculin'}, {'cui': 'C0037296', 'cui_str': 'Skin Tests'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",82.0,0.163119,"RESULTS
IFN-γ levels declined between baseline and the end of IPT (signed rank test P≤.0001) and between baseline and a similar period of observation without IPT (signed rank test P=.03).","[{'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Geldenhuys', 'Affiliation': ''}, {'ForeName': 'Bonnie A', 'Initials': 'BA', 'LastName': 'Thiel', 'Affiliation': ''}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Toefy', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Suliman', 'Affiliation': ''}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Pienaar', 'Affiliation': ''}, {'ForeName': 'Phalkun', 'Initials': 'P', 'LastName': 'Chheng', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Scriba', 'Affiliation': ''}, {'ForeName': 'W Henry', 'Initials': 'WH', 'LastName': 'Boom', 'Affiliation': ''}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Hanekom', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hatherill', 'Affiliation': ''}]",Chest,['10.1378/chest.13-1232']
826,32422538,Short- and long-term changes in substance-related coping as mediators of in-person and computerized CBT for alcohol and drug use disorders.,"BACKGROUND
No studies have examined long-term changes in substance-related coping skills as a statistical mediator of cognitive-behavioral therapy (CBT) for substance use disorders (SUD).
METHODS
We tested both short- and long-term changes in coping as mediators of treatment effects in two trials of in-person and/or computerized CBT for SUD. The first trial included 137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in-person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU). The second trial included 68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following: CBT4CBT plus brief monitoring, CBT4CBT plus TAU, or TAU only. Coping was assessed with the Coping Strategies Scale. Latent growth curve mediational models were conducted, with both short-term (baseline through end-of-treatment) and long-term (baseline through 3-month post-treatment follow-up) changes in coping.
RESULTS
There were no mediation effects for short-term changes in coping. However, in both trials, there were significant mediation effects for long-term changes in coping: In trial 1, the effect of CBT4CBT vs. TAU on substance use at the 6-month follow-up was mediated by long-term increases in coping. This same mediation effect was not found for in-person CBT vs. TAU. In trial 2, the effect of CBT4CBT vs. not receiving CBT4CBT on heavy drinking at the 6-month follow-up was mediated by long-term increases in coping.
CONCLUSIONS
Long-term increases in coping may be a mechanism of change in computerized CBT for SUD.",2020,This same mediation effect was not found for in-person CBT vs. TAU.,"['68 individuals (65 % male; 66.2 % non-white; mean age = 42.7) with an alcohol use disorder randomized to one of the following', 'two trials of in-person and/or computerized CBT for SUD', '137 individuals (75 % male; 65.7 % non-White; mean age = 35.9) with drug and/or alcohol use disorders randomized to one of the following: in']","['CBT4CBT vs. TAU', 'CBT4CBT vs. not receiving CBT4CBT', 'person CBT, computer-delivered CBT (CBT4CBT) plus brief monitoring, or treatment-as-usual (TAU']","['coping', 'heavy drinking']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1998288', 'cui_str': 'Computerized cognitive behavioral therapy'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",137.0,0.0462548,This same mediation effect was not found for in-person CBT vs. TAU.,"[{'ForeName': 'Corey R', 'Initials': 'CR', 'LastName': 'Roos', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States. Electronic address: corey.roos@yale.edu.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Carroll', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Charla', 'Initials': 'C', 'LastName': 'Nich', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Tami', 'Initials': 'T', 'LastName': 'Frankforter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Kiluk', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, 06510, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108044']
827,32040244,Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial.,"OBJECTIVE
Enhanced cognitive behavior therapy (CBT-E) is a transdiagnostic treatment suitable for the full range of eating disorders (EDs). Although the effectiveness of CBT(-E) is clear, it is not being used as widely in clinical practice as guidelines recommend. The aim of the present study was to compare the effectiveness of CBT-E with treatment as usual (TAU), which was largely based on CBT principles.
METHOD
We conducted a randomized controlled trial on a total of 143 adult patients with an ED who received either CBT-E or TAU. The primary outcome was recovery from the ED. Secondary outcome measures were levels of ED psychopathology, anxiety, and depressive symptoms. Self-esteem, perfectionism, and interpersonal problems were repeatedly measured to examine possible moderating effects. We explored differences in duration and intensity between conditions.
RESULTS
After 80 weeks, there were no differences between conditions in decrease in ED psychopathology, or symptoms of anxiety and depression. However, in the first six weeks of treatment there was a larger decrease in ED psychopathology in the CBT-E condition. Moreover, when the internationally most widely used definition of recovery was applied, the recovery rate at 20 weeks of CBT-E was significantly higher (57.7%) than of TAU (36.0%). At 80 weeks, this difference was no longer significant (CBT-E 60.9%; TAU 43.6%). Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment.
DISCUSSION
With broader use of CBT-E, the efficiency, accessibility and effectivity (on self-esteem) of treatment for EDs could be improved.",2020,"Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment.
","['143 adult patients with an ED who received either', 'eating disorders']","['enhanced cognitive behavior therapy', 'CBT-E or TAU', 'CBT(-E', 'CBT-E', 'cognitive behavior therapy (CBT-E']","['recovery rate', 'Self-esteem, perfectionism, and interpersonal problems', 'levels of ED psychopathology, anxiety, and depressive symptoms', 'self-esteem', 'efficiency, accessibility and effectivity', 'recovery from the ED', 'ED psychopathology, or symptoms of anxiety and depression', 'ED psychopathology']","[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",143.0,0.132319,"Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment.
","[{'ForeName': 'Martie', 'Initials': 'M', 'LastName': 'de Jong', 'Affiliation': 'Center for Eating Disorders, PsyQ, Part of Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Deen', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van der Meer', 'Affiliation': 'Center for Eating Disorders, PsyQ, Part of Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Unna N', 'Initials': 'UN', 'LastName': 'Danner', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'van der Schuur', 'Affiliation': 'Center for Eating Disorders-PsyQ, Part of Lentis Psychiatric Institute, Groningen, The Netherlands.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Hoek', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}]",The International journal of eating disorders,['10.1002/eat.23239']
828,31866190,"A multicenter, randomized, double-blind, controlled study to evaluate the efficacy and safety of dantrolene on ventricular arrhythmia as well as mortality and morbidity in patients with chronic heart failure (SHO-IN trial): rationale and design.","BACKGROUND
Leakage of Ca 2+ from the sarcoplasmic reticulum (SR) is a critical contributing factor to heart failure pathophysiology. Therefore, reducing SR Ca 2+ leaks may provide significant additive benefits when used in combination with conventional therapies. Dantrolene, a drug routinely used to treat malignant hyperthermia, also stabilizes the cardiac isoform of the release channel (RyR2), thus decreasing SR Ca 2+ leaks. The purpose of this study is to evaluate the effect of chronic administration of dantrolene on heart failure and lethal arrhythmia in patients with chronic heart failure and reduced ejection fraction in a multicenter, randomized, double-blind, controlled study.
METHODS
Patients with chronic heart failure who had functional status of New York Heart Association class II and III and a left ventricular ejection fraction <40% were treated according to the Japanese Circulation Society, the European Society of Cardiology, and the American Heart Association/the American College of Cardiology guidelines for diagnosis and treatment of acute and chronic heart failure. Patients were randomized and divided into two groups in a double-blind fashion: dantrolene group and placebo group (target sample size: 300 cases). These drugs were administered for 96 weeks. The primary endpoint is cardiovascular death, first hospitalization for exacerbation of heart failure, or lethal arrhythmia [ventricular tachycardia (VT) storm, sustained VT, ventricular fibrillation] for 2 years after starting administration of dantrolene 1 cap (25mg) three times daily (if not tolerable, two times daily) or matching placebo.
RESULTS
This paper presents the rationale and trial design of the study. Recruitment for the study started on 8 December 2017.
CONCLUSIONS
The results of this trial will clarify the efficacy and safety of dantrolene for ventricular arrhythmia, as well as mortality and morbidity in patients with chronic heart failure and reduced ejection fraction during guideline-directed medical treatment.",2020,"The primary endpoint is cardiovascular death, first hospitalization for exacerbation of heart failure, or lethal arrhythmia [ventricular tachycardia (VT) storm, sustained VT, ventricular fibrillation] for 2 years after starting administration of dantrolene 1 cap (25mg) three times daily (if not tolerable, two times daily) or matching placebo.
","['patients with chronic heart failure and reduced ejection fraction', 'Patients with chronic heart failure who had functional status of New York Heart Association class II and III and a left ventricular ejection fraction <40% were treated according to the Japanese Circulation Society, the European Society of Cardiology, and the American Heart Association/the American College of Cardiology guidelines for diagnosis and treatment of acute and chronic heart failure', 'patients with chronic heart failure (SHO-IN trial', 'patients with chronic heart failure and reduced ejection fraction during guideline-directed medical treatment']","['placebo', 'dantrolene']","['heart failure and lethal arrhythmia', 'mortality and morbidity', 'efficacy and safety', 'cardiovascular death, first hospitalization for exacerbation of heart failure, or lethal arrhythmia [ventricular tachycardia (VT) storm, sustained VT, ventricular fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010976', 'cui_str': 'Dantrolene'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0042514', 'cui_str': 'Tachycardia, Ventricular'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0042510', 'cui_str': 'Ventricular Fibrillation'}]",300.0,0.143152,"The primary endpoint is cardiovascular death, first hospitalization for exacerbation of heart failure, or lethal arrhythmia [ventricular tachycardia (VT) storm, sustained VT, ventricular fibrillation] for 2 years after starting administration of dantrolene 1 cap (25mg) three times daily (if not tolerable, two times daily) or matching placebo.
","[{'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan. Electronic address: skoba@yamaguchi-u.ac.jp.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Wakeyama', 'Affiliation': 'Division of Cardiology, JCHO Tokuyama Central Hospital, Shunan, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Ono', 'Affiliation': 'Division of Cardiology, Saiseikai Yamaguchi General Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Division of Cardiology, Yamaguchi Prefectural Grand Medical Center, Hofu, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Omura', 'Affiliation': 'Division of Cardiology, Saiseikai Shimonoseki General Hospital, Shimonoseki, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Oda', 'Affiliation': 'Division of Cardiology, Shimane Prefectural Central Hospital, Izumo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Hisamatsu', 'Affiliation': 'Division of Cardiology, JCHO Shimonoseki Medical Center, Shimonoseki, Japan.'}, {'ForeName': 'Kozaburo', 'Initials': 'K', 'LastName': 'Seki', 'Affiliation': 'Division of Cardiology, Yamaguchi Rosai Hospital, Sanyo-Onoda, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Satoh', 'Affiliation': 'Division of Cardiology, Ehime Rosai Hospital, Niihama, Japan.'}, {'ForeName': 'Mitsuyuki', 'Initials': 'M', 'LastName': 'Hiromoto', 'Affiliation': 'Division of Cardiology, Shuto General Hospital, Yanai, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Akashi', 'Affiliation': 'Division of Cardiology, Hamada Medical Center, Hamada, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Uchida', 'Affiliation': 'Division of Cardiology, Hagi Civil Hospital, Hagi, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Harada', 'Affiliation': 'Division of Cardiology, Ube-kohsan Central Hospital, Ube, Japan.'}, {'ForeName': 'Yuhji', 'Initials': 'Y', 'LastName': 'Furutani', 'Affiliation': 'Department of Cardiology, Kanmon Medical Center, Shimonoseki, Japan.'}, {'ForeName': 'Yasuma', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine, Hikari City General Hospital, Hikari, Japan.'}, {'ForeName': 'Masateru', 'Initials': 'M', 'LastName': 'Kohno', 'Affiliation': 'Department of Cardiovascular Medicine, Shunan City Shinnanyo Hospital, Shunan, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kawamura', 'Affiliation': 'Department of Cardiovascular Medicine, Konan Saint Hill Hospital, Ube, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Obayashi', 'Affiliation': 'Department of Cardiovascular Medicine, Sanyo-Onoda City Hospital, Sanyo-Onoda, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Michishige', 'Affiliation': 'Department of Cardiovascular Medicine, Japanese Red Cross Society Yamaguchi Hospital, Yamaguchi, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.08.020']
829,24980988,"A Randomized, blinded assessor study to Evaluate the efFIcacy and safety of etanercept 50 mg once weekly plus as Needed topical agent vs. Etanercept 50 mg twice weekly in patients with moderate to severe plaque psoriasis (REFINE).","BACKGROUND
Topical corticosteroids are used with systemic therapies for treatment of plaque psoriasis, but data from randomized clinical trials to document efficacy of combination therapy are lacking.
OBJECTIVE
To evaluate efficacy and safety of adding topical corticosteroid therapy from the time that etanercept dosage is reduced from initial label dose [50 mg twice weekly (BIW)] to maintenance dose [50 mg once weekly (QW)].
METHODS
In this phase 3b, multicentre, randomized, open-label study, patients with moderate-to-severe plaque psoriasis received etanercept 50 mg BIW for 12 weeks, and then were randomized to etanercept 50 mg BIW or 50 mg QW plus topical agent as needed to achieve static physician global assessment (sPGA) status of clear for 12 weeks. Endpoints included percentage change in Psoriasis Area and Severity Index (PASI) score from week 12 to week 24 (primary endpoint); proportion of patients achieving 50% improvement in (PASI 50), PASI 75 and PASI 90; patients achieving sPGA of clear/almost clear; and change in affected body surface area (BSA).
RESULTS
Mean difference [95% confidence interval (CI)] between etanercept arm (n = 140) and etanercept plus topical arm (n = 142) in change in PASI score from week 12 to week 24 was 16.2% (-3.5%, 35.8%). PASI response rates were similar between groups. Percentage (95% CI) of patients achieving sPGA status of clear/almost clear was 40.6% (32.5%, 48.6%) and 45.8% (37.6%, 54.0%) at week 12 for patients in etanercept and etanercept plus topical arms, respectively, and 53.5% (45.3%, 61.7%) and 45.4% (37.2%, 53.6%) at week 24. Difference (95% CI) between groups in change in affected BSA from week 12 to week 24 was 4.9% (-23.4%, 33.2%).
CONCLUSION
Patients who received etanercept 50 mg QW at week 12 plus as-needed topical therapy and those who stayed on etanercept 50 mg BIW maintained clinical response through week 24 with no notable differences in PASI responses.",2015,"Difference (95% CI) between groups in change in affected BSA from week 12 to week 24 was 4.9% (-23.4%, 33.2%).
","['patients with moderate-to-severe plaque psoriasis received', 'patients with moderate to severe plaque psoriasis (REFINE']","['etanercept', 'etanercept 50 mg BIW', 'topical corticosteroid therapy', 'etanercept 50 mg QW', 'etanercept 50 mg BIW or 50 mg QW plus topical agent', 'Etanercept']","['PASI response rates', 'PASI responses', 'efficacy and safety', 'static physician global assessment (sPGA) status', 'body surface area (BSA', 'PASI score', 'percentage change in Psoriasis Area and Severity Index (PASI) score', 'efFIcacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",142.0,0.204219,"Difference (95% CI) between groups in change in affected BSA from week 12 to week 24 was 4.9% (-23.4%, 33.2%).
","[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Barber', 'Affiliation': 'Kirk Barber Research, Calgary, AB, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bourcier', 'Affiliation': 'Dermatology Clinic, Moncton, NB, Canada.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Lynde', 'Affiliation': 'Lynde Centre for Dermatology, Markham, ON, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Centre Dermatologique du Quebec Metropolitain, Quebec, QC, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shelton', 'Affiliation': 'Amgen Canada Inc., Mississauga, ON, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Toole', 'Affiliation': 'University of Manitoba and Probity Medical Research, Winnipeg, MB, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vieira', 'Affiliation': 'Amgen Canada Inc., Mississauga, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Poulin-Costello', 'Affiliation': 'Amgen Canada Inc., Mississauga, ON, Canada.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.12555']
830,24909188,"Efficacy and safety of topical glycopyrrolate in patients with facial hyperhidrosis: a randomized, multicentre, double-blinded, placebo-controlled, split-face study.","BACKGROUND
Although facial hyperhidrosis has been frequently associated with a diminished quality of life, various conservative modalities for its management are still far from satisfactory.
OBJECTIVE
To evaluate the antiperspirant efficacy and safety of the topical glycopyrrolate on facial hyperhidrosis at specified posttreatment intervals.
METHODS
Thirty-nine patients with facial hyperhidrosis were enrolled and treated with 2% topical glycopyrrolate on one-half of the forehead, whereas the other half of the forehead was treated with a placebo. All patients applied topical glycopyrrolate or placebo once a day for nine successive days. Each evaluation included weighing sweat and assessing the Hyperhidrosis Disease Severity Scale (HDSS) score and any adverse effects.
RESULTS
Compared with the placebo-treated sides, topical glycopyrrolate-treated sides showed a reduction in the rate of sweat production at the forehead of 25.16 ± 10.30% (mean ± SD) at 90 min after the first application (day 1), 29.63 ± 7.74% at 24 h after the first application (day 2) and 36.68 ± 11.41% at 24 h after eight additional successive daily applications (day 10) (all P < 0.025). There was a little more decrease in HDSS score with the topical glycopyrrolate-treated half of the forehead, but the difference was not statistically significant (P > 0.025). No serious adverse events were reported during the course of this study. Only one patient developed a transient headache after treatment.
CONCLUSION
Topical glycopyrrolate application appears to be significantly effective and safe in reducing excessive facial perspiration.",2015,"There was a little more decrease in HDSS score with the topical glycopyrrolate-treated half of the forehead, but the difference was not statistically significant (P > 0.025).","['patients with facial hyperhidrosis', 'Thirty-nine patients with facial hyperhidrosis were enrolled and treated with 2']","['placebo', 'topical glycopyrrolate or placebo', 'glycopyrrolate', 'Topical glycopyrrolate', 'topical glycopyrrolate']","['transient headache', 'Efficacy and safety', 'serious adverse events', 'excessive facial perspiration', 'facial hyperhidrosis', 'weighing sweat and assessing the Hyperhidrosis Disease Severity Scale (HDSS) score and any adverse effects', 'rate of sweat production', 'HDSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0033268'}]",39.0,0.22463,"There was a little more decrease in HDSS score with the topical glycopyrrolate-treated half of the forehead, but the difference was not statistically significant (P > 0.025).","[{'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Hyun', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Son', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'K Y', 'Initials': 'KY', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Seo', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Hong', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.12518']
831,24846518,Adalimumab for the treatment of moderate to severe psoriasis: subanalysis of effects on scalp and nails in the BELIEVE study.,"BACKGROUND/OBJECTIVE
This post hoc analysis examined the effects of adalimumab in patients with scalp and/or nail psoriasis from BELIEVE (a randomized, controlled, multicentre phase 3 safety and efficacy trial).
METHODS
Efficacy was assessed in the pooled treatment group (adalimumab with or without calcipotriol plus betamethasone dipropionate) by Psoriasis Area and Severity Index (75% improvement; PASI 75), Psoriasis Scalp Severity Index (PSSI), Nail Psoriasis Severity Index (NAPSI), Dermatology Life Quality Index (DLQI) and a visual analog scale (VAS) for pain.
RESULTS
Of the 730 enrolled patients, 663 (91.3%), 457 (63.1%) and 433 (60.1%) had psoriasis of the scalp, nails, or both, respectively. Similar proportions of patients with (68.2%) and without (63.5%) scalp involvement achieved a PASI 75 response at week 16 [adjusted odds ratio (OR), 1.34; P = 0.320]. PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 (53.0% vs. 62.9%; OR, 0.68; P = 0.019) and week 16 (65.0% vs. 73.0%; OR, 0.70; P = 0.052). PASI 75 response rates were 66.1% in patients with scalp and nail involvement and 70.8% in patients without both scalp and nail involvement at week 16 (OR, 0.87; P = 0.423). Patients in all scalp and nail subgroups reported improvements in DLQI and VAS pain scores throughout the study. Patients with scalp psoriasis exhibited large improvements in scalp symptoms demonstrated by a median (mean ± SD) decrease from baseline PSSI at week 16 of 100% (77.2 ± 96.9%). Patients with nail psoriasis improved, demonstrated by a median (mean ± SD) decrease from baseline NAPSI at week 16 of 39.5% (9.4 ± 164.5%).
CONCLUSION
Our results indicate that adalimumab improves overall psoriasis and scalp and nail symptoms in this patient population with scalp psoriasis and/or nail involvement. In addition, similar PASI 75 response rates are achieved in patients with and without scalp involvement, whereas patients with nail involvement demonstrate a moderate (perhaps delayed) PASI 75 response rate.",2015,"PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 (53.0% vs. 62.9%; OR, 0.68; P = 0.019) and week 16 (65.0% vs. 73.0%; OR, 0.70; P = 0.052).","['patient population with scalp psoriasis and/or nail involvement', 'Patients with scalp psoriasis', 'patients with scalp and/or nail psoriasis', 'Patients with nail psoriasis', '730 enrolled patients, 663 (91.3%), 457 (63.1%) and 433 (60.1%) had psoriasis of the scalp, nails, or both, respectively', 'moderate to severe psoriasis']","['adalimumab with or without calcipotriol plus betamethasone dipropionate', 'Adalimumab', 'adalimumab']","['PASI 75 response rates', 'DLQI and VAS pain scores', 'Efficacy', 'scalp symptoms', 'Psoriasis Scalp Severity Index (PSSI), Nail Psoriasis Severity Index (NAPSI), Dermatology Life Quality Index (DLQI) and a visual analog scale (VAS) for pain', 'PASI 75 response', 'Psoriasis Area and Severity Index', 'overall psoriasis and scalp and nail symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis (disorder)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail (disorder)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0065767', 'cui_str': 'calcipotriol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0053523', 'cui_str': 'betamethasone dipropionate'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail (disorder)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027342', 'cui_str': 'Nails'}]",730.0,0.0671005,"PASI 75 response rates were lower in patients with nail psoriasis compared with patients without nail psoriasis at week 8 (53.0% vs. 62.9%; OR, 0.68; P = 0.019) and week 16 (65.0% vs. 73.0%; OR, 0.70; P = 0.052).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Unnebrink', 'Affiliation': 'AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sundaram', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sood', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.12553']
832,31386826,Effects of high-intensity interval training and nutrition advice on cardiometabolic markers and aerobic fitness in adolescent girls with obesity.,"The aim of the study was to compare the effects of high-intensity interval training (HIIT) and nutrition advice on cardiometabolic biomarkers, hormonal parameters, and cardiorespiratory fitness in adolescent girls with obesity. Adolescent girls with obesity ( n = 44, aged 13-19 years) were randomized into a 12-week intervention as follows: ( i ) dietary advice and HIIT ( n = 22), and ( ii ) dietary advice only ( n = 22). The concentration of biomarkers of inflammation, biochemical and hormonal testing, oral glucose tolerance test, cardiorespiratory fitness, physical activity levels, and nutrition were assessed. After a 3-month intervention, the diet+HIIT group significantly increased insulin sensitivity index (-0.34 ± 1.52 vs. 1.05 ± 3.21; p = 0.001) and work load (0.6 ± 11.3 W vs. 14.6 ± 20.2 W; p = 0.024) and decreased glucose area under the curve (-0.29 ± 4.69 vs. -0.98 ± 4.06; p = 0.040), insulin area under the curve (-9.65 ± 117.9 vs. -98.7 ± 201.8; p = 0.003), and high-sensitivity C-reactive protein (hs-CRP) (0.12 ± 1.92 mg/L vs. -1.47 ± 3.67 mg/L; p = 0.039) in comparison with the diet group. Regarding within-group changes, both groups had significant improvements in body mass index (BMI), BMI-standard deviation score, body fat percentage, and systolic blood pressure. Positive impact on waist circumference, waist circumference/height ratio, diastolic blood pressure, hs-CRP, work load, maximal heart rate, and resting heart rate was observed only after the diet+HIIT intervention. No significant change was noted in peak oxygen uptake, lipid profile, and hormonal parameters between groups after intervention. Novelty HIIT and nutrition advice increased insulin sensitivity and decreased BMI, body fat, systolic blood pressure, and diastolic blood pressure. Nutrition advice decreased BMI, body fat, and systolic blood pressure in adolescent girls with obesity.",2020,"No significant change was noted in peak oxygen uptake, lipid profile and hormonal parameters between groups after intervention.","['adolescent girls with obesity', 'Adolescent girls with obesity (n = 44, 13-19 years old']","['dietary advice and HIIT (n = 22), and 2) dietary advice only', 'high-intensity interval training (HIIT) and nutrition advice', 'high-intensity interval training and nutrition advice']","['peak oxygen uptake, lipid profile and hormonal parameters', 'GlucoseAUC', 'insulin sensitivity and decrease BMI, body fat, systolic and diastolic blood pressure •', 'waist circumference, waist circumference/height ratio, diastolic blood pressure, hsCRP, work load, maximal and rest heart rate', 'Insulin sensitivity index', 'body mass index (BMI), BMI-standard deviation score, body fat percentage and systolic blood pressure', 'hsCRP', 'Novelty', 'Nutrition advice decrease BMI, body fat and systolic blood pressure', 'cardiometabolic biomarkers, hormonal parameters and cardiorespiratory fitness', 'work load', 'cardiometabolic markers and aerobic fitness', 'concentration of biomarkers of inflammation, biochemical and hormonal testing, oral glucose tolerance test, cardiorespiratory fitness, physical activity levels and nutrition']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.016399,"No significant change was noted in peak oxygen uptake, lipid profile and hormonal parameters between groups after intervention.","[{'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Plavsic', 'Affiliation': 'Department of Pediatric and Adolescent Gynecology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 6-8, 11070 Belgrade, Serbia.'}, {'ForeName': 'Olivera M', 'Initials': 'OM', 'LastName': 'Knezevic', 'Affiliation': 'Institute for Medical Research, University of Belgrade, Dr Subotica 4, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Sovtic', 'Affiliation': 'Department of Pulmonology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 6-8, 11070 Belgrade, Serbia.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Minic', 'Affiliation': 'Department of Pulmonology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 6-8, 11070 Belgrade, Serbia.'}, {'ForeName': 'Rade', 'Initials': 'R', 'LastName': 'Vukovic', 'Affiliation': 'School of Medicine, University of Belgrade, Dr Subotica 8, 11000 Belgrade, Serbia.'}, {'ForeName': 'Ilijana', 'Initials': 'I', 'LastName': 'Mazibrada', 'Affiliation': 'Department of Pediatric and Adolescent Gynecology, Mother and Child Health Care Institute of Serbia ""Dr Vukan Cupic"", Radoja Dakica 6-8, 11070 Belgrade, Serbia.'}, {'ForeName': 'Olivera', 'Initials': 'O', 'LastName': 'Stanojlovic', 'Affiliation': 'Institute of Medical Physiology, Faculty of Medicine, University of Belgrade, Visegradska 26, 11000 Belgrade, Serbia.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Hrncic', 'Affiliation': 'Institute of Medical Physiology, Faculty of Medicine, University of Belgrade, Visegradska 26, 11000 Belgrade, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Rasic-Markovic', 'Affiliation': 'Institute of Medical Physiology, Faculty of Medicine, University of Belgrade, Visegradska 26, 11000 Belgrade, Serbia.'}, {'ForeName': 'Djuro', 'Initials': 'D', 'LastName': 'Macut', 'Affiliation': 'Clinic of Endocrinology, Diabetes and Metabolic Diseases, Faculty of Medicine, University of Belgrade, Dr Subotica 13, 11000 Belgrade, Serbia.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0137']
833,32423247,Effect of Nasal Steroids on Nasal Obstruction in Septal Deviation: A Double-Blind Randomized Controlled Trial.,"Objective: This study sought to prospectively determine the effect of intranasal steroids versus placebo on nasal obstruction in septal deviation. Methods: This was a single-center randomized placebo-controlled double-blind trial with crossover in which all study participants received 6 weeks of therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher). Participants were randomized to one of two groups with a 2-week washout period between drugs. Nasal Obstruction Symptom Evaluation (NOSE) scores were collected at baseline and after each study drug. A subset of patients subsequently underwent surgical intervention after both drugs and additional NOSE scores were collected postoperatively. Results: Forty-two patients completed both study drugs with NOSE scores collected. Thirty-two patients underwent surgery and postoperative NOSE scores were collected. There was no significant difference in baseline demographics between the groups. There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs. There was no difference in the change in mean NOSE score from baseline to postsaline (-3.9) versus baseline to poststeroid (-5.8, p = 0.60). Surgery resulted in a significant change in NOSE score at all postoperative time points (mean of -50, range of -47.2 to -53.6). Conclusions: We found no significant effect of intranasal steroids on nasal obstruction as compared with placebo. Surgery, however, was associated with significant sustained improvement in nasal obstruction. These data suggest that in patients with nasal obstruction due to a fixed cause, medical therapy with intranasal steroids is unlikely to be beneficial.",2020,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"['Nasal Obstruction in Septal Deviation', 'patients with nasal obstruction', 'Results: Forty-two patients completed both study drugs with NOSE scores collected']","['intranasal steroids', 'intranasal steroids versus placebo', 'Nasal Steroids', 'therapy with Nasacort (Chattem, Inc.) and with Ayr saline spray (B.F. Ascher', 'placebo']","['mean NOSE scores', 'mean NOSE score', 'NOSE score', 'baseline demographics', 'Nasal Obstruction Symptom Evaluation (NOSE) scores', 'nasal obstruction', 'postoperative NOSE scores']","[{'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C0549397', 'cui_str': 'Deviated nasal septum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0594040', 'cui_str': 'Nasacort'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",42.0,0.347848,There was no significant difference in mean NOSE scores in either group from baseline to the completion of the first and second study drugs.,"[{'ForeName': 'Shannon F', 'Initials': 'SF', 'LastName': 'Rudy', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Cherian', 'Initials': 'C', 'LastName': 'Kandathil', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Spataro', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Sami P', 'Initials': 'SP', 'LastName': 'Moubayed', 'Affiliation': 'Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Montreal, Montréal, Canada.'}, {'ForeName': 'Sam P', 'Initials': 'SP', 'LastName': 'Most', 'Affiliation': 'Division of Facial Plastic and Reconstructive Surgery, Department of Otolaryngology-Head and Neck Surgery, Stanford University School of Medicine, Stanford, California, USA.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2020.0150']
834,22373561,Effect of automatic image realignment on visuomotor coordination in simulated laparoscopic surgery.,"During laparoscopic surgery, the surgeon's hand-eye coordination is often disrupted by the incongruent mapping between the orientation of the endoscopic view and the actual operative field. Two experiments were conducted to examine the effect of automatic image realignment on the performance of laparoscopic surgery. The first experiment investigated how visual-motor misalignment impacted laparoscopic surgery performance. Novice subjects were randomly assigned to one of the two paired viewing conditions in a simulated laparoscopic surgery environment: 1) the endoscope was either at the center of the modeled workspace with an optical axis of 90°, or at -45° from the midline of the subjects with an optical axis 45°; 2) the endoscope was either at 0°, or at 180° from the midline of the subjects, both with an optical axis of 45°. Each group of twelve subjects performed a dynamic point-and-touch task under the assigned pair of viewing conditions, each with eight image orientations, in a repeated-measures mixed design. The second experiment examined whether the automatic realigning mechanism that was activated mid-task (such that a congruent mapping between display and control was re-established if the mapping at the beginning of the task had been misaligned) was helpful to improve performance. Twelve novice subjects performed the same task as in the first experiment in a repeated-measures design. Performance was examined under three misaligned visuomotor mappings, each followed by the realigned mapping activated by the automatic realigning mechanism. Results showed that performance was best when the endoscopic image was perfectly aligned with the actual task space (0° image orientation), but degraded progressively as a function of deviation from perfect alignment. Subjects' performance maintained a consistent pattern across 8 image orientations regardless of optical axis orientation and endoscope location. Performance was improved with the automatic realigning mechanism. It is recommended that any solution to restore the visuomotor congruency in laparoscopic surgery should first align the image with the task space. This work has implications for the design of visualization systems in laparoscopic surgery.",2012,"Results showed that performance was best when the endoscopic image was perfectly aligned with the actual task space (0° image orientation), but degraded progressively as a function of deviation from perfect alignment.","['simulated laparoscopic surgery', 'Novice subjects', 'laparoscopic surgery', 'Twelve novice subjects']","['simulated laparoscopic surgery environment: 1) the endoscope was either at the center of the modeled workspace with an optical axis of 90°, or at -45° from the midline of the subjects with an optical axis 45°; 2) the endoscope was either at 0°, or at 180° from the midline of the subjects, both with an optical axis of 45°', 'automatic image realignment', 'visual-motor misalignment impacted laparoscopic surgery performance']",['visuomotor coordination'],"[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0014243', 'cui_str': 'Endoscopes'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0441606', 'cui_str': 'Realignment - action'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1275957', 'cui_str': 'Misalignment'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}]",12.0,0.0223695,"Results showed that performance was best when the endoscopic image was perfectly aligned with the actual task space (0° image orientation), but degraded progressively as a function of deviation from perfect alignment.","[{'ForeName': 'Likun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Mechanical Engineering Department, Tufts University, Medford, MA, USA.'}, {'ForeName': 'Caroline G L', 'Initials': 'CG', 'LastName': 'Cao', 'Affiliation': ''}]",Applied ergonomics,['10.1016/j.apergo.2012.02.001']
835,31916704,Evaluation of Pharmacokinetics and Dose Proportionality of Diazepam After Intranasal Administration of NRL-1 to Healthy Volunteers.,"NRL-1 is a novel intranasal formulation of diazepam that is being evaluated as rescue medication in patients with epilepsy who experience bouts of increased seizure activity despite stable regimens of antiepileptic drugs. This phase 1, open-label, randomized, crossover study in healthy adult volunteers consisted of 3 single-dose periods (5, 10, and 20 mg) followed by a 2-dose period (2 × 10 mg) with a minimum 28-day washout between treatments. Blood samples were taken at prespecified time points after intranasal dosing, and bioanalytic analysis of diazepam and nordiazepam was conducted using a validated liquid chromatography-tandem mass spectrometry method. Plasma pharmacokinetic parameters were summarized using descriptive statistics, and dose proportionality (peak concentration [C max ] and area under the plasma concentration-time curve [AUC 0-∞ ]) was evaluated based on a power model within a 90%CI of 0.84 to 1.16. Comparisons were also conducted between single 10-mg dose and multidose (2 × 10 mg) treatments. NRL-1 administration resulted in rapid diazepam absorption (median time to peak concentration 1.4-1.5 hours). Plasma concentration-time profiles showed similar patterns of exposure that appeared to be dose dependent, with C max of 85.6, 133.6, and 235.3 ng/mL for the 5-, 10-, and 20-mg doses, respectively, although the lower 90%CI for C max and AUC 0-∞ exceeded dose proportionality criteria. The coefficient of variation ranged from 59% to 67% for C max and 48% to 56% for AUC parameters. Dose-normalized AUC 0-∞ values were comparable between the 2 × 10-mg and single 10-mg doses. Treatment-emergent adverse events were consistent with those expected for diazepam, with transient somnolence the most frequent adverse event (94.4%). These results support NRL-1 as a potential therapy for managing seizure emergencies.",2020,NRL-1 administration resulted in rapid diazepam absorption (median time to peak concentration 1.4-1.5 hours).,"['Healthy Volunteers', 'patients with epilepsy who experience bouts of increased seizure activity despite stable regimens of antiepileptic drugs', 'healthy adult volunteers']","['diazepam and nordiazepam', 'Diazepam', 'NRL-1', 'diazepam']","['rapid diazepam absorption', 'Plasma pharmacokinetic parameters', 'dose proportionality (peak concentration [C max ] and area under the plasma concentration-time curve [AUC 0-∞ ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0011279', 'cui_str': 'Nordazepam'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.0330675,NRL-1 administration resulted in rapid diazepam absorption (median time to peak concentration 1.4-1.5 hours).,"[{'ForeName': 'Sarina', 'Initials': 'S', 'LastName': 'Tanimoto', 'Affiliation': 'Pacific Link Consulting, San Diego, California, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Pesco Koplowitz', 'Affiliation': 'DUCK FLATS Pharma, Elbridge, New York, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Lowenthal', 'Affiliation': 'Pacific Link Consulting, San Diego, California, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Koplowitz', 'Affiliation': 'DUCK FLATS Pharma, Elbridge, New York, USA.'}, {'ForeName': 'Adrian L', 'Initials': 'AL', 'LastName': 'Rabinowicz', 'Affiliation': 'Neurelis, Inc, San Diego, California, USA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Carrazana', 'Affiliation': 'Neurelis, Inc, San Diego, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.767']
836,32046656,Stratified primary care versus non-stratified care for musculoskeletal pain: qualitative findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.,"BACKGROUND
Stratified care involves subgrouping patients based on key characteristics, e.g. prognostic risk, and matching these subgroups to appropriate early treatment options. The STarT MSK feasibility and pilot cluster randomised controlled trial (RCT) examined the feasibility of a future main trial and of delivering prognostic stratified primary care for patients with musculoskeletal pain. The pilot RCT was conducted in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK development tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. This paper reports on a nested qualitative study exploring the feasibility of delivering stratified care ahead of the main trial.
METHODS
'Stimulated-recall' interviews were conducted with patients and GPs in the stratified care arm (n = 10 patients; 10 GPs), prompted by consultation recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Capability, Opportunity and Motivation GPs and patients had to engage with stratified care.
RESULTS
Patients reported positive views that stratified care enabled a more 'structured' consultation, and felt tool items were useful in making GPs aware of patients' worries and concerns. However, the closed nature of the tool's items was seen as a barrier to opening up discussion. GPs identified difficulties integrating the tool within consultations (Opportunity), but found this easier as it became more familiar. Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability). Most GPs reported that the matched treatment options aided their clinical decision-making (Motivation), but identified some options that were not available to them (e.g. pain management clinics), and other options that were not included in the matched treatments but which were felt appropriate for some patients (e.g. consider imaging).
CONCLUSION
This nested qualitative study, using the COM-B model, identified amendments required for the main trial including changes to the Keele STarT MSK tool and matched treatment options, targeting the COM-B model constructs, and these have been implemented in the current main trial.
TRIAL REGISTRATION
ISRCTN 15366334.",2020,"Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability).","[""Stimulated-recall' interviews were conducted with patients and GPs in the stratified care arm (n\xa0=\u200910 patients; 10 GPs"", 'patients with musculoskeletal pain', '8 UK general practices (4 stratified care; 4 usual care) with 524 patients']",['Stratified primary care versus non-stratified care'],[],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],,0.0699847,"Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK. b.saunders@keele.ac.uk.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Cooper', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Protheroe', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chudyk', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chew-Graham', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Bartlam', 'Affiliation': 'Primary Care Centre Versus Arthritis, School for Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}]",BMC family practice,['10.1186/s12875-020-1098-1']
837,32033535,"Tele-transitions of care (TTOC): a 12-month, randomized controlled trial evaluating the use of Telehealth to achieve triple aim objectives.","BACKGROUND
Poor transitions of care leads to increased health costs, over-utilization of emergency room departments, increased re-hospitalizations and causes poor patient experiences and outcomes. This study evaluated Telehealth feasibility in improving transitions of care.
METHODS
This is a 12-month randomized controlled trial, evaluating the use of telehealth (remote patient monitoring and video visits) versus standard transitions of care with the primary outcomes of hospital readmission and emergency department utilization and secondary outcomes of access to care, medication management and adherence and patient engagement. Electronic Medical Record data, Health Information Exchange data and phone survey data was collected. Multi-variable logistic regression models were created to evaluate the effect of Telehealth on hospital readmission, emergency department utilization, medication adherence. Chi-square tests or Fisher's exact tests were used to compare the percentages of categorical variables between the Telehealth and control groups. T tests or Wilcoxon rank sum tests were used to compared means and medians between the two randomized groups.
RESULTS
The study conducted between June 2017 and 2018, included 102 patients. Compared with the standard of care, Telehealth patients were more likely to have medicine reconciliation (p = 0.013) and were 7 times more likely to adhere to medication than the control group (p = 0.03). Telehealth patients exhibited enthusiasm (p = 0.0001), and confidence that Telehealth could improve their healthcare (p = 0.0001). Telehealth showed no statistical significance on emergency department utilization (p = 0.691) nor for readmissions (p = 0.31). 100% of Telehealth patients found the intervention to be valuable, 98% if given the opportunity, reported they would continue using telehealth to manage their healthcare needs, and 94% reported that the remote patient monitoring technology was useful.
CONCLUSIONS
Telehealth can improve transitions of care after hospital discharge improving patient engagement and adherence to medications. Although this study was unable to show the effect of Telehealth on reduced healthcare utilization, more research needs to be done in order to understand the true impact of Telehealth on preventing avoidable hospital readmission and emergency department visits.
TRIAL REGISTRATION
ClinicalTrials.Gov ID: NCT03528850 Date Registered (Retrospective): 5/18/2018. Status: Completed. IRB #: 970227.",2020,Telehealth showed no statistical significance on emergency department utilization (p = 0.691) nor for readmissions (p = 0.31).,"['Gov ID', 'June 2017 and 2018, included 102 patients']",['telehealth (remote patient monitoring and video visits'],"['hospital readmission, emergency department utilization, medication adherence', 'emergency department utilization', 'medicine reconciliation']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0030695', 'cui_str': 'Patient Monitoring'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",,0.0720835,Telehealth showed no statistical significance on emergency department utilization (p = 0.691) nor for readmissions (p = 0.31).,"[{'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Noel', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook Medicine, Stony Brook, New York, 11794, USA. kimberly.noel@stonybrookmedicine.edu.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Messina', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook Medicine, Stony Brook, New York, 11794, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hou', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook Medicine, Stony Brook, New York, 11794, USA.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook Medicine, Stony Brook, New York, 11794, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Kelly', 'Affiliation': 'Department of Family, Population and Preventive Medicine, Stony Brook Medicine, Stony Brook, New York, 11794, USA.'}]",BMC family practice,['10.1186/s12875-020-1094-5']
838,32421909,Contrasting Personal Characteristics and Psychosocial Correlates of Exercise and Eating Behavior Changes in Women Successful vs. Unsuccessful with Weight Loss and Maintenance.,"BACKGROUND
There is great variability in individuals' responses to behavioral weight-loss treatments. Beyond attaining meaningful weight loss in the initial several weeks, little is known of the characteristics of participants successful vs. unsuccessful with short- and long-term weight loss.
METHODS
Separate samples of women with obesity enrolled in cognitive-behavioral weight-loss treatments were assessed over 6 months (Study 1: successful weight-loss group, n = 83; unsuccessful group, n = 158), and over 24 months (Study 2: sustained initially lost weight, n = 25; regained weight, n = 19), on personal characteristics and theory-driven psychosocial variables.
RESULTS
In Study 1, significantly older age and greater eating self-regulation at baseline were found in the successful group. Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group. In Study 2, the sustainer group had significantly more favorable changes over 2 years in exercise- and eating-related self-regulation, and mood. During Months 6-24, the psychosocial correlates of both exercise and eating behaviors regressed, with more pronounced reversions in the regainer group.
CONCLUSION
Increasing the magnitude of treatment-associated improvement in each of the tested theory-based psychosocial factors is warranted to increase probabilities for success with attaining and maintaining meaningful weight loss.",2020,"Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group.","['Separate samples of women with obesity enrolled in cognitive-behavioral weight-loss treatments were assessed over 6\xa0months (Study 1: successful weight-loss group, n\xa0=\xa083; unsuccessful group, n\xa0=\xa0158), and over 24\xa0months (Study 2: sustained initially lost weight, n\xa0=\xa025; regained weight, n\xa0=\xa019), on personal characteristics and theory-driven psychosocial variables']",[],"['exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction', 'eating self-regulation']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0336377,"Significantly greater improvements in exercise- and eating-related self-regulation, mood, exercise- and eating-related self-efficacy, physical self-concept, and body satisfaction were found in the successful group.","[{'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Annesi', 'Affiliation': 'YMCA of Metro Atlanta, Atlanta, GA, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12203']
839,21637134,"Anterior Approach Versus Posterior Approach With Subtotal Corpectomy, Decompression, and Reconstruction of Spine in the Treatment of Thoracolumbar Burst Fractures: A Prospective Randomized Controlled Study.","STUDY DESIGN
A randomized, controlled follow-up study.
OBJECTIVE
The objective of this study was to compare the results of anterior approach versus posterior approach with subtotal corpectomy, decompression, and reconstruction of spine in the treatment of thoracolumbar burst fractures.
SUMMARY OF BACKGROUND DATA
Burst fractures are frequently associated with instability or neurological deficit. Anterior subtotal corpectomy, decompression, and reconstruction with instrumentation are an established method for a highly unstable burst fracture. In the past few years, subtotal corpectomy, decompression, and reconstruction of spine could be completed by posterior approach. Posterior segmental pedicle screw instrumentation, with its more rigid fixation and less technically demanding, could offer potential advantages.
METHODS
A total of 64 patients with thoracolumbar burst fractures were divided into 2 groups randomly. Group A was treated by anterior approach and group B was treated by posterior approach with subtotal corpectomy, decompression, and reconstruction of spine. During the minimum 24 months (range, 24 to 72 mo) follow-up period, all patients were prospectively evaluated for clinical and radiologic outcomes. The intraoperative blood loss, operative time, complications of operation, pulmonary function, Frankel scale, and the American Spinal Injury Association (ASIA) motor score were used for clinical evaluation, whereas the heights of anterior edge of vertebral body and the Cobb angle were examined for radiologic outcome. RESULTS: All patients in this study achieved solid fusion, with significant neurological improvement. The intraoperative blood loss (P<0.05) and complications of operation were less, the operative time was shorter (P<0.05), and the pulmonary function after operation was better in the group B (P<0.05). The Frankel scale, the ASIA motor score, and the radiologic results were not significantly different (P<0.05) at all time points between the 2 groups A and B. But the 2 groups improved in their neurological function by approximately 1.3 Frankel grade and 15.6 ASIA motor scores at final follow-up.
CONCLUSION
Anterior approach and posterior approach with subtotal corpectomy, decompression, and reconstruction of spine are sufficient for surgical treatment of thoracolumbar burst fractures. Less intraoperative blood loss and complications, shorter operative time, and better pulmonary function after operation are the significant advantages of posterior surgery.",2012,"The intraoperative blood loss (P<0.05) and complications of operation were less, the operative time was shorter (P<0.05), and the pulmonary function after operation was better in the group B (P<0.05).","['thoracolumbar burst fractures', 'Thoracolumbar Burst Fractures', '64 patients with thoracolumbar burst fractures']","['Anterior subtotal corpectomy, decompression, and reconstruction with instrumentation', 'Anterior approach and posterior approach with subtotal corpectomy, decompression, and reconstruction of spine', 'Anterior Approach Versus Posterior Approach With Subtotal Corpectomy, Decompression, and Reconstruction of Spine', 'anterior approach and group B was treated by posterior approach with subtotal corpectomy, decompression, and reconstruction of spine', 'Posterior segmental pedicle screw instrumentation', 'anterior approach versus posterior approach with subtotal corpectomy, decompression, and reconstruction of spine']","['heights of anterior edge of vertebral body and the Cobb angle', 'intraoperative blood loss, operative time, complications of operation, pulmonary function, Frankel scale, and the American Spinal Injury Association (ASIA) motor score', 'intraoperative blood loss and complications, shorter operative time, and better pulmonary function', 'pulmonary function', 'intraoperative blood loss (P<0.05) and complications of operation', 'operative time', 'Frankel scale, the ASIA motor score, and the radiologic results', 'neurological function']","[{'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0728939', 'cui_str': 'Subtotal (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0451163', 'cui_str': 'Frankel grading system for spinal cord injury (assessment scale)'}, {'cui': 'C0037937', 'cui_str': 'Spinal Injuries'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027767', 'cui_str': 'Nervous System Physiology'}]",64.0,0.0173165,"The intraoperative blood loss (P<0.05) and complications of operation were less, the operative time was shorter (P<0.05), and the pulmonary function after operation was better in the group B (P<0.05).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedics, the 175th Hospital of PLA, Traumatic Orthopaedics Center of PLA, Southeast Hospital of Xiamen University, Zhangzhou Fujian Province PR China.'}, {'ForeName': 'Zhi-Wen', 'Initials': 'ZW', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Zhong-Kai', 'Initials': 'ZK', 'LastName': 'Yi', 'Affiliation': ''}]",Journal of spinal disorders & techniques,[]
840,32046647,Stratified primary care versus non-stratified care for musculoskeletal pain: findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.,"BACKGROUND
Musculoskeletal (MSK) pain from the five most common presentations to primary care (back, neck, shoulder, knee or multi-site pain), where the majority of patients are managed, is a costly global health challenge. At present, first-line decision-making is based on clinical reasoning and stratified models of care have only been tested in patients with low back pain. We therefore, examined the feasibility of; a) a future definitive cluster randomised controlled trial (RCT), and b) General Practitioners (GPs) providing stratified care at the point-of-consultation for these five most common MSK pain presentations.
METHODS
The design was a pragmatic pilot, two parallel-arm (stratified versus non-stratified care), cluster RCT and the setting was 8 UK GP practices (4 intervention, 4 control) with randomisation (stratified by practice size) and blinding of trial statistician and outcome data-collectors. Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template. The intervention was supported by the EMR template housing the Keele STarT MSK Tool (to stratify into low, medium and high-risk prognostic subgroups of persistent pain and disability) and recommended matched treatment options. Feasibility outcomes included exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity. To capture recommended outcomes including pain and function, participants completed an initial questionnaire, brief monthly questionnaire (postal or SMS), and 6-month follow-up questionnaire. An anonymised EMR audit described GP decision-making.
RESULTS
GPs screened 3063 patients (intervention = 1591, control = 1472), completed the EMR template with 1237 eligible patients (intervention = 513, control = 724) and 524 participants (42%) consented to data collection (intervention = 231, control = 293). Recruitment took 28 weeks (target 12 weeks) with > 90% follow-up retention (target > 75%). We detected no selection bias of concern and no harms identified. GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved ""complete success"".
CONCLUSIONS
A future definitive cluster RCT of stratified care for MSK pain is feasible and is underway, following key amendments including a clinician-completed version of the stratification tool and refinements to recommended matched treatments.
TRIAL REGISTRATION
Name of the registry: ISRCTN.
TRIAL REGISTRATION NUMBER
15366334. Date of registration: 06/04/2016.",2020,"GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved ""complete success"".
","['Potential participant records were tagged and individuals sent postal invitations using a GP point-of-consultation electronic medical record (EMR) template', '3063 patients (intervention\u2009=\u20091591, control\u2009=\u20091472), completed the EMR template with 1237 eligible patients (intervention\u2009=\u2009513, control\u2009=\u2009724) and 524 participants (42%) consented to data collection (intervention\u2009=\u2009231, control\u2009=\u2009293', 'patients with low back pain', 'Participants were adult consulters with MSK pain without indicators of serious pathologies, urgent medical needs, or vulnerabilities']",['Stratified primary care versus non-stratified care'],"['exploration of recruitment and follow-up rates, selection bias, and GP intervention fidelity']","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C4317132', 'cui_str': 'Template'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036577', 'cui_str': 'Selection Bias'}]",,0.142764,"GP stratification tool fidelity failed to achieve a-priori success criteria, whilst fidelity to the matched treatments achieved ""complete success"".
","[{'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK. j.hill@keele.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Garvin', 'Affiliation': 'Keele Clinical Trials Unit, School for Primary, Community and Social Care, Faculty of Medicine and Health Sciences, Keele University, Newcastle, UK.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cooper', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wathall', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Protheroe', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chudyk', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Dunn', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van der Windt', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, ST5 5BG, UK.'}]",BMC family practice,['10.1186/s12875-019-1074-9']
841,31596119,Validation of two-dimensional vertebral body parameters in estimating patient height in elderly patients.,"OBJECTIVES
Standardised comparison of abdominal muscle and adipose tissue is often utilised in morphometric clinical research. Whilst measurements are traditionally standardised against the patient's height, this may not be always practically feasible. The aim of this study was to investigate the relationship between measurements of the vertebral body and patient height.
METHODS
We analysed cross-sectional CT scans. Measurements of the vertebral body area (VBA), anteroposterior vertebral body diameter (APVBD) and lateral vertebral body diameter (LVBD) were made by two independent investigators by manual tracing. Patients were randomly divided into two groups: Group 1 standardisation and Group 2 validation. We compared height and vertebral body parameters from patients in Group 1 and mathematically modelled this relationship. We then utilised the model to predict the height of patients in Group 2 and compared this with their actual height. Observer variability was assessed using Bland-Altman plots and t -tests of differences.
RESULTS
CT scans from 382 patients were analysed. No significant intraobserver or interobserver differences were apparent when measuring vertebral body parameters. We describe models which enable the prediction of the patients' height using the measured VBA, APVBD and LVBD. No significant differences were observed between the patients predicted and actual heights in the validation group.
CONCLUSIONS
We demonstrate an important relationship between measurements of the patient's height and the vertebral body. This can be utilised in future research when the patient's height has not been measured.
ADVANCES IN KNOWLEDGE
In the absence of the patient's height, we demonstrate that two-dimensional vertebral body parameters may be reliably used to standardise morphometric measurements.",2019,No significant intra- or inter observer differences were apparent when measuring vertebral body parameters.,"['elderly patients', '382 patients were analysed']",[],"['actual heights', 'Observer variability', 'vertebral body area (VBA), anteroposterior vertebral body diameter (APVBD) and lateral vertebral body diameter (LVBD']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}]",[],"[{'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}]",382.0,0.0222099,No significant intra- or inter observer differences were apparent when measuring vertebral body parameters.,"[{'ForeName': 'Mohammed Abdul', 'Initials': 'MA', 'LastName': 'Waduud', 'Affiliation': 'The Leeds Vascular Institute, Leeds General Infirmary, Leeds Teaching Hospital NHS Trust, Great George St, Leeds LS1 3EX, United Kingdom.'}, {'ForeName': 'Penelope Poppy Janpen', 'Initials': 'PPJ', 'LastName': 'Sucharitkul', 'Affiliation': 'The Leeds Vascular Institute, Leeds General Infirmary, Leeds Teaching Hospital NHS Trust, Great George St, Leeds LS1 3EX, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Drozd', 'Affiliation': 'Leeds Institute for Cardiovascular and Metabolic Medicine, University of Leeds, LIGHT Laboratories, Level 7, Leeds, LS2 9JT, United Kingdom.'}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'The Leeds Vascular Institute, Leeds General Infirmary, Leeds Teaching Hospital NHS Trust, Great George St, Leeds LS1 3EX, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hammond', 'Affiliation': 'Department of Radiology, Leeds General Infirmary, Leeds Teaching Hospital NHS Trust, Great George St, Leeds LS1 3EX, United Kingdom.'}, {'ForeName': 'David Julian', 'Initials': 'DJ', 'LastName': 'Ashbridge Scott', 'Affiliation': 'The Leeds Vascular Institute, Leeds General Infirmary, Leeds Teaching Hospital NHS Trust, Great George St, Leeds LS1 3EX, United Kingdom.'}]",The British journal of radiology,['10.1259/bjr.20190342']
842,31596129,MRI evaluation of extramural vascular invasion by inexperienced radiologists.,"OBJECTIVE
We proposed to determine whether the performance of inexperienced radiologists in determining extramural vascular invasion (EMVI) in rectal cancer on MRI can be promoted by means of targeted training.
METHODS
230 rectal cancer patients who underwent pre-operative chemoradiotherapy were included. Pre-therapy and post-therapy MR images and pathology EMVI evaluation were available for cases. 230 cases were randomly divided into 150 training cases and 80 testing cases, including 40 testing case A and 40 testing case B. Four radiologists were included for MRI EMVI evaluation, who were divided into targeted training group and non-targeted training group. The two groups evaluated testing case A at baseline, 3 month and 6 month, evaluated testing case B at 6 month. The main outcome was agreement with expert-reference for pre-therapy and post-therapy evaluation, the other outcome was accuracy with pathology for post-therapy evaluation.
RESULTS
After 6 months of training, targeted training group showed statistically higher agreement with expert-reference than non-targeted training group for both pre-therapy and post-therapy MRI EMVI evaluation of testing case A and testing case B, all p < 0.05. Targeted training group also showed significantly higher accuracy with pathology than non-targeted training group for post-therapy evaluation of testing case A and testing case B after 6 months of training, all p < 0.05.
CONCLUSION
The diagnostic performance for MRI EMVI evaluation could be promoted by targeted training for inexperienced radiologist.
ADVANCES IN KNOWLEDGE
This study provided the first evidence that after 6 month targeted training, inexperienced radiologists demonstrated improved diagnostic performance, with a 20% increase in agreement with expert-reference for both pre-therapy and post-therapy MRI EMVI evaluation and also a 20% increase in or accuracy with pathology for post-therapy evaluation, while inexperienced radiologists could not gain obvious improvement in MRI EMVI evaluation through the same period of regular clinical practice. It indicated that targeted training may be necessary for helping inexperienced radiologist to acquire adequate experience for the MRI EMVI evaluation of rectal cancer, especially for radiologist who works in a medical unit where MRI EMVI diagnosis is uncommon.",2019,"Targeted training group also showed significantly higher accuracy with pathology than non-targeted training group for post-therapy evaluation of testing case A and testing case B after 6 months of training, all p < 0.05.
","['230 rectal cancer patients who underwent', 'A and 40 testing case B. Four radiologists were included for MRI EMVI evaluation', '230 cases were randomly divided into 150 training cases and 80 testing cases, including 40 testing case']","['targeted training group and non-targeted training group', 'preoperative chemoradiotherapy']","['accuracy with pathology', 'diagnostic performance', 'MRI EMVI evaluation']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0260194', 'cui_str': 'Radiologist (occupation)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",230.0,0.0216304,"Targeted training group also showed significantly higher accuracy with pathology than non-targeted training group for post-therapy evaluation of testing case A and testing case B after 6 months of training, all p < 0.05.
","[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Li', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}, {'ForeName': 'Rui-Jia', 'Initials': 'RJ', 'LastName': 'Sun', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}, {'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Qu', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}, {'ForeName': 'Hui-Ci', 'Initials': 'HC', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Guan', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}, {'ForeName': 'Ying-Shi', 'Initials': 'YS', 'LastName': 'Sun', 'Affiliation': 'Department of Radiology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, Hai Dian District, Beijing 100142, China.'}]",The British journal of radiology,['10.1259/bjr.20181055']
843,31536837,"Intrauterine Instillation of Tranexamic Acid in Hysteroscopic Myomectomy: A Double-Blind, Placebo-Controlled, Parallel-Group Randomized Clinical Trial.","STUDY OBJECTIVE
To evaluate the hemostatic effect of intrauterine instillation of tranexamic acid (TXA) with the distention medium during hysteroscopic myomectomy.
DESIGN
Prospective, parallel-group, double-blind, placebo-controlled randomized clinical trial.
SETTING
Early Cancer Detection Unit in Ain Shams University Maternity Hospital, Cairo, Egypt.
PATIENTS
Eighty women with type 0 or I submucous myoma undergoing hysteroscopic myomectomy using unipolar resectoscope.
INTERVENTIONS
The participants were randomly assigned to receive either 1 g of TXA for every 1000 mL of the distending medium (intervention group) or 10 mL of placebo (10 mL of 1.5% glycine) in the same form inside every 1000 mL of the distention medium.
MEASUREMENTS AND MAIN RESULTS
The primary outcome was a change in hemoglobin level 24 hours after surgery compared with preoperative values, and the secondary outcomes were the surgeon's rating of intraoperative bleeding and the quality of operative view, the duration of surgery, the volume of injected media, intraoperative complications, and the completion of myomectomy in 1 procedure. The mean difference in hemoglobin level was 1.11 ±.58 g/dL in the TXA group and 1.46 ± 0.61 g/dL in the placebo group (p = .015). The quality of hysteroscopic view was better in the TXA group (p = .001), with good operative view in 23 (60.5%) cases in TXA vs 8 (20.5%) in the placebo group. The surgeon's rating of bleeding as excessive was reported in 1 (2.6%) case in the TXA group and in 9 (23.1%) cases in the placebo group. There was no difference between the groups regarding the duration of surgery, the volume of injected media, completion of myoma resection in 1 session, and intraoperative complications. Three cases of uterine perforation with the thermal loop were reported, and all were associated with poor operative field in the placebo group.
CONCLUSION
Intrauterine instillation of TXA with the distention medium during hysteroscopic myomectomy resulted in a statistically significant decrease in hemoglobin level 24 hours after surgery, albeit with minimal clinical significance. TXA resulted in better visualization of the field throughout the procedure.",2020,"3 cases of uterine perforation with the thermal loop were reported, all were associated with poor operative field in the placebo group.
","['University hospital', '80 women with type 0 or 1 submucous myoma undergoing', 'Hysteroscopic Myomectomy']","['Placebo', 'tranexamic acid', 'Tranexamic Acid', 'TXA 1gm for every 1000 ml of the distending medium (intervention group), or 10 ml of placebo (10 ml of 1.5% glycine', 'placebo', 'hysteroscopic myomectomy using unipolar resectoscope', 'TXA']","['change in hemoglobin level', 'hemoglobin level', 'Quality of hysteroscopic view', 'surgeon rating of intraoperative bleeding and the quality of operative view, the duration of surgery, the volume of injected media, intraoperative complications and the completion of myomectomy', 'duration of surgery, the volume of injected media, completion of myoma resection in one session, and intraoperative complications', 'hemoglobin level reduction', 'surgeon rating of bleeding as excessive', 'uterine perforation']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0182966', 'cui_str': 'Resectoscope (physical object)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0079027', 'cui_str': 'Hemorrhage, Surgical'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4521936', 'cui_str': 'Inject (administration method)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}, {'cui': 'C0027086', 'cui_str': 'Myoma'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0042139', 'cui_str': 'Uterine Perforation'}]",80.0,0.467471,"3 cases of uterine perforation with the thermal loop were reported, all were associated with poor operative field in the placebo group.
","[{'ForeName': 'Radwa', 'Initials': 'R', 'LastName': 'Rasheedy', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt (all authors).. Electronic address: radwaebed@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Makled', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt (all authors).'}, {'ForeName': 'Amgad', 'Initials': 'A', 'LastName': 'Abou-Gamrah', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt (all authors).'}, {'ForeName': 'Hajer', 'Initials': 'H', 'LastName': 'Giuma', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt (all authors).'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.09.773']
844,32048396,"Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study.","AIM
To evaluate the effect of adding the dipeptidyl-peptidase-4 inhibitor vildagliptin to insulin on the glycaemic control of patients with type 2 diabetes undergoing haemodialysis.
METHODS
Overall, 65 insulin-treated patients with type 2 diabetes undergoing haemodialysis (HbA1c: 7.3% ± 1.1%; age: 70.5 ± 8.5 years) were randomized (1:1) either to receive vildagliptin 50 mg/day in addition to insulin (vildagliptin-insulin group) or to pursue their usual insulin regimen (insulin-only group). Continuous glucose monitoring (CGM) was performed for 48 ± 6 hours at baseline and at week 12. The primary study endpoint was change from baseline in mean interstitial glucose using CGM. The secondary endpoints included other CGM variables and glucose control markers.
RESULTS
After 12 weeks, a greater reduction in mean CGM glucose from baseline was observed in the vildagliptin-insulin group compared with the insulin-only group, although the between-treatment difference was not statistically significant (mean difference [CI 95%]: -0.96 mmol/L [-2.09; 0.18] vs. -0.29 mmol/L [-1.29; 0.76], P = 0.32). However, a significant decrease from baseline in HbA1c, glycated albumin and insulin daily doses was observed in the vildagliptin-insulin group versus the insulin-only group (-0.6% [-1.19; -0.1], P < 0.01), in the vildagliptin-insulin group versus no change in the insulin-only group (-130.6 μmol/L [-271; 10.7] vs. +36.2 μmol/L [-164.4; 236.9], P = 0.04 and - 5.9 IU/day [-1.8; 7.1] vs. +1.1 IU/day [-14.5; 16.6], P = 0.01, respectively). There was no significant difference in the percentage of time spent in hypoglycaemia using CGM, occurrence of severe hypoglycaemia or number of adverse events.
CONCLUSION
In this study, vildagliptin added to insulin improved glycaemic control with an associated insulin-sparing effect in patients with type 2 diabetes undergoing haemodialysis and was well tolerated.",2020,"There was no significant difference in the percentage of time spent in hypoglycaemia using CGM, occurrence of severe hypoglycaemia or number of adverse events.
","['Hemodialyzed Patients with Type 2 Diabetes', '65 insulin-treated patients with type 2 diabetes undergoing haemodialysis (HbA1c: 7.3% ±\u20091.1%; age: 70.5 ±\u20098.5\u2009years', 'patients with type 2 diabetes undergoing haemodialysis']","['dipeptidyl-peptidase-4 inhibitor vildagliptin', 'vildagliptin-insulin', 'Continuous glucose monitoring (CGM', 'Vildagliptin', 'vildagliptin 50 mg/day in addition to insulin (vildagliptin-insulin group) or to pursue their usual insulin regimen (insulin-only group', 'vildagliptin']","['mean CGM glucose', 'HbA1c, glycated albumin and insulin daily doses', 'mean interstitial glucose using CGM', 'percentage of time spent in hypoglycaemia using CGM, occurrence of severe hypoglycaemia or number of adverse events', 'tolerated', 'CGM variables and glucose control markers']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720467', 'cui_str': 'Only'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0061700', 'cui_str': 'glycosylated serum albumin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",,0.0516875,"There was no significant difference in the percentage of time spent in hypoglycaemia using CGM, occurrence of severe hypoglycaemia or number of adverse events.
","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Munch', 'Affiliation': 'CHU Strasbourg, Department of Diabetology, Strasbourg, Alsace, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'CHU Strasbourg, Department of Diabetology, Strasbourg, Alsace, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Hannedouche', 'Affiliation': 'CHU Strasbourg, Department of Nephrology, Strasbourg, Alsace, France.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kunz', 'Affiliation': 'AURAL, Nephrology, Strasbourg, Alsace, France.'}, {'ForeName': 'Farideh', 'Initials': 'F', 'LastName': 'Alenabi', 'Affiliation': 'AURAL, Nephrology, Strasbourg, Alsace, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Winiszewski', 'Affiliation': 'CH Mulhouse, Department of Diabetology, Mulhouse, Grand Est, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Baltzinger', 'Affiliation': 'CHU Strasbourg, Department of Diabetology, Strasbourg, Alsace, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Smagala', 'Affiliation': 'CH Colmar, Department of Diabetology, Alsace, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'CH Colmar, Department of Nephrology, Alsace, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dorey', 'Affiliation': 'CH Valenciennes, Department of Diabetology, Nord, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Fleury', 'Affiliation': 'CH Valenciennes, Department of Nephrology, Nord, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Verier-Mine', 'Affiliation': 'CH Valenciennes, Department of Diabetology, Nord, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Guerci', 'Affiliation': 'CHU Nancy, Department of Diabetology, Lorraine, France.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Cridlig', 'Affiliation': 'CHU Nancy, Department of Nephrology, Lorraine, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Borot', 'Affiliation': 'CHU Besançon, Department of Diabetology, Franche Comté, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Ducloux', 'Affiliation': 'CHU Besançon, Department of Nephrology, Franche Comté, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Strasbourg University Teaching Hospital, Federation of Translational Medicine, Strasbourg, France.'}, {'ForeName': 'Samy', 'Initials': 'S', 'LastName': 'Hadjadj', 'Affiliation': 'Department of Diabetology, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Chantrel', 'Affiliation': 'CH Mulhouse, Department of Nephrology, Mulhouse, Alsace, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Kessler', 'Affiliation': 'CHU Strasbourg, Department of Diabetology, Strasbourg, Alsace, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13988']
845,31313118,Associations of Diabetes Genetic Risk Counseling with Incident Diabetes and Weight: 5-Year Follow-up of a Randomized Controlled Trial.,,2020,,[],[],[],[],[],[],,0.0738647,,"[{'ForeName': 'Sridharan', 'Initials': 'S', 'LastName': 'Raghavan', 'Affiliation': 'Department of Veterans Affairs Eastern Colorado Health Care System, Aurora, CO, USA. Sridharan.raghavan@ucdenver.edu.'}, {'ForeName': 'Kerui', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Coffman', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham, NC, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Pabich', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Durham Center of Innovation to Accelerate Discovery and Practice Transformation, Durham, NC, USA.'}, {'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05126-z']
846,31502637,Usefulness of myocardial work measurement in the assessment of left ventricular systolic reserve response to spironolactone in heart failure with preserved ejection fraction.,"AIMS
Improvement in left ventricular (LV) systolic reserve, including exertional increase in global longitudinal strain (GLS), may contribute to the clinical benefit from therapeutic interventions in heart failure with preserved ejection fraction (HFpEF). However, GLS is an afterload-dependent parameter, and its measurements may not adequately reflect myocardial contractility recruitment with exercise. The estimation of myocardial work (MW) allows correction of GLS for changing afterload. We sought to investigate the associations of GLS and MW parameters with the response of exercise capacity to spironolactone in HFpEF.
METHODS AND RESULTS
We analysed 114 patients (67 ± 8 years) participating in the STRUCTURE study (57 randomized to spironolactone and 57 to placebo). Resting and immediately post-exercise echocardiograms were performed at baseline and at 6-month follow-up. The following indices of MW were assessed: global work index (GWI), global constructive work (GCW), global wasted work, and global work efficiency. The amelioration of exercise intolerance at follow-up in the spironolactone group was accompanied by a significant improvement in exertional increase in GCW (P = 0.002) but not in GLS and other MW parameters. Increase in exercise capacity at 6 months was independently correlated with change in exertional increase in GCW from baseline to follow-up (β = 0.24; P = 0.009) but not with GLS (P = 0.14); however, no significant interaction with the use of spironolactone on peak VO2 was found (P = 0.97).
CONCLUSION
GCW as a measure of LV contractile response to exertion is a better determinant of exercise capacity in HFpEF than GLS. Improvement in functional capacity during follow-up is associated with improvement in exertional increment of GCW.",2019,"Increase in exercise capacity at 6 months was independently correlated with change in exertional increase in GCW from baseline to follow-up (β = 0.24; P = 0.009) but not with GLS (P = 0.14); however, no significant interaction with the use of spironolactone on peak VO2 was found (P = 0.97).
","['114 patients (67\u2009±\u20098\u2009years) participating in the STRUCTURE study (57 randomized to', 'heart failure with preserved ejection fraction', 'heart failure with preserved ejection fraction (HFpEF']","['spironolactone and 57 to placebo', 'GLS', 'spironolactone']","['global work index (GWI), global constructive work (GCW), global wasted work, and global work efficiency', 'peak VO2', 'exertional increase in GCW', 'exercise capacity', 'functional capacity', 'left ventricular (LV) systolic reserve', 'amelioration of exercise intolerance']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}]",114.0,0.0251786,"Increase in exercise capacity at 6 months was independently correlated with change in exertional increase in GCW from baseline to follow-up (β = 0.24; P = 0.009) but not with GLS (P = 0.14); however, no significant interaction with the use of spironolactone on peak VO2 was found (P = 0.97).
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Przewlocka-Kosmala', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Marwick', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St, Hobart TAS, Australia.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Mysiak', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kosowski', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Kosmala', 'Affiliation': 'Cardiology Department, Wroclaw Medical University, Borowska 213, Wroclaw, Poland.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jez027']
847,31748253,Prenatal and Infancy Nurse Home Visiting Effects on Mothers: 18-Year Follow-up of a Randomized Trial.,"BACKGROUND
Prenatal and infancy home-visiting by nurses is promoted as a means of improving maternal life-course, but evidence of long-term effects is limited. We hypothesized that nurse-visitation would lead to long-term reductions in public-benefit costs, maternal substance abuse and depression, and that cost-savings would be greater for mothers with initially higher psychological resources.
METHODS
We conducted an 18-year follow-up of 618 out of 742 low-income, primarily African-American mothers with no previous live births enrolled in an randomized clinical trial of prenatal and infancy home visiting by nurses. We compared nurse-visited and control-group women for public-benefit costs, rates of substance abuse and depression, and examined possible mediators of intervention effects.
RESULTS
Nurse-visited women, compared with controls, incurred $17 310 less in public benefit costs ( P = .03), an effect more pronounced for women with higher psychological resources ($28 847, P = .01). These savings compare with program costs of $12 578. There were no program effects on substance abuseor depression. Nurse-visited women were more likely to be married from child age 2 through 18 (19.2% vs 14.8%, P = .04), and those with higher psychological resources had 4.64 fewer cumulative years rearing subsequent children after the birth of the first child ( P = .03). Pregnancy planning was a significant mediator of program effects on public benefit costs.
CONCLUSIONS
Through child age 18, the program reduced public-benefit costs, an effect more pronounced for mothers with higher psychological resources and mediated by subsequent pregnancy planning. There were no effects on maternal substance abuse and depression.",2019,"Through child age 18, the program reduced public-benefit costs, an effect more pronounced for mothers with higher psychological resources and mediated by subsequent pregnancy planning.","['18-year follow-up of 618 out of 742 low-income, primarily African-American mothers with no previous live births enrolled in an randomized clinical trial of prenatal and infancy home visiting by nurses', 'Mothers']",[],"['psychological resources', 'maternal substance abuse and depression', 'substance abuseor depression', 'public benefit costs']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C3494673', 'cui_str': 'Maternal substance abuse (situation)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",742.0,0.0919465,"Through child age 18, the program reduced public-benefit costs, an effect more pronounced for mothers with higher psychological resources and mediated by subsequent pregnancy planning.","[{'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Olds', 'Affiliation': 'Departments of Pediatrics and david.olds@cuanschutz.edu.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Anson', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Knudtson', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation, School of Public Health, Curtin University, Perth, Australia; and.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cole', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hopfer', 'Affiliation': 'Psychiatry, University of Colorado, Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': 'Departments of Economics and Social Science, University College London, London, United Kingdom.'}]",Pediatrics,['10.1542/peds.2018-3889']
848,31571560,What makes one respond to acupuncture for insomnia? Perspectives of cancer survivors.,"OBJECTIVE
Like any therapy, acupuncture is effective for some patients, while not helpful for others. Understanding from a patients' perspective what makes one respond or not to acupuncture can help guide further intervention development. This study aimed to identify factors that influence the perception of acupuncture's therapeutic effect among cancer survivors with insomnia.
METHOD
We conducted post-treatment semi-structured interviews with cancer survivors who were randomized to the acupuncture group in a clinical trial for the treatment of insomnia. Survivors were categorized into Responders and Non-Responders to acupuncture treatment based on the change in the Insomnia Severity Index with a reduction of eight points or greater as the cut-off for the response. An integrated approach to data analysis was utilized by merging an a priori set of codes derived from the key ideas and a set of codes that emerged from the data through a grounded theory approach. Codes were examined for themes and patterns.
RESULTS
Among 28 cancer survivors interviewed, 18 (64%) were classified as Responders. Participants perceived the ability to respond to acupuncture as dependent on treatment that effectively: (1) alleviated co-morbidities contributing to insomnia, (2) supported sleep hygiene practices, and (3) provided a durable therapeutic effect. Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture.
SIGNIFICANCE OF RESULTS
We identified patient-perceived contributors to response to acupuncture, such as co-morbid medical conditions, adequate support for sleep hygiene practices, and temporary therapeutic relief. Addressing these factors may improve the overall effectiveness of acupuncture for insomnia.",2020,"Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture.
","['28 cancer survivors', 'cancer survivors with insomnia', 'cancer survivors']","['acupuncture', 'Acupuncture']",['Insomnia Severity Index'],"[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}]",,0.0602409,"Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture.
","[{'ForeName': 'Sally A D', 'Initials': 'SAD', 'LastName': 'Romero', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Jiang', 'Affiliation': 'School of Medicine, New York University, New York, NY.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bussell', 'Affiliation': 'A Center for Oriental Medicine, Chicago, IL.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Eriksen', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Duhamel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Frances K', 'Initials': 'FK', 'LastName': 'Barg', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Palliative & supportive care,['10.1017/S1478951519000762']
849,31529084,Transitional Hypoglycaemia Management in Small for Gestational Age Neonates with Sucrose Enriched Expressed Breastmilk in Resource Poor Setting.,"AIM
To find out if oral sucrose is as efficacious as intravenous dextrose (IVDx) in treating hypoglycaemia in small for gestational age (SGA) neonates and to compare risk of feed intolerance (FI) and necrotizing enterocolitis (NEC) in oral therapy with IVDx therapy.
METHODS
Eighty SGA haemodynamically stable hypoglycaemic [blood sugar (BS) < 40 mg/dl] neonates of ≥32 to ≤36 week gestational age were randomized to receive oral sugar enriched expressed breastmilk (EBM; Group A) or IV dextrose therapy (Group B; 40 in each group) in similar calculated doses. BS at 6 h after treatment, incidence of recurrence of hypoglycaemia, FI and NEC were compared.
RESULTS
Mean BS level at 6 h after treatment in oral supplementation group was 63.53 ± 22.12 mg/dl [3.52 ± 1.22 mmol/l (IQR 49.2-82 mg/dl, 2.7-4.5 mmol/l) vs. 71.28 ± 31.76 mg/dl [3.96 ± 1.76 mmol/l (IQR 48.5-73 mg/dl, 2.69-4 mmol/l) in IVDx group, p = 0.209. Relative risk (RR) of recurrence of hypoglycaemia in oral vs. IV treatment was 1.5 with 95% CI 0.4578-4.9151. Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
CONCLUSION
In resource poor setting in haemodynamically stable hypoglycaemic SGA neonates, EBM enriched with calculated dose of sucrose given orally maintains euglycaemia (BS 40-125mg/dl, 2.2-6.9 mmol/l) without increased incidence of FI and NEC. This method also prevents lactational failure.",2020,"Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
","['treating hypoglycaemia in small for gestational age (SGA) neonates', '\u200940 mg/dl] neonates of ≥32 to ≤36\u2009week gestational age', 'Eighty']","['oral sucrose', 'dextrose (IVDx', 'oral sugar enriched expressed breastmilk (EBM; Group A) or IV dextrose therapy']","['incidence of recurrence of hypoglycaemia, FI and NEC', 'Relative risk (RR) of recurrence of hypoglycaemia', 'Incidence of FI', 'Mean BS level', 'incidence of FI and NEC', 'SGA haemodynamically stable hypoglycaemic [blood sugar (BS', 'Transitional Hypoglycaemia Management']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0912341', 'cui_str': ""N'(OB)EC""}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0150254', 'cui_str': 'Hypoglycemia management'}]",80.0,0.148124,"Incidence of FI (p = 0.49, RR 1, 95%CI 0.3-3.1) and NEC (p = 0.4, RR 0.2, 95%CI 0.01-4.2) was comparable.
","[{'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Bora', 'Affiliation': 'Neonatal Unit, Department of Paediatrics, Assam Medical College, Dibrugarh, Assam, India.'}, {'ForeName': 'Sumon', 'Initials': 'S', 'LastName': 'Deori', 'Affiliation': 'Neonatal Unit, Department of Paediatrics, Assam Medical College, Dibrugarh, Assam, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz064']
850,31557306,Pharmacogenomics and Placebo Response in a Randomized Clinical Trial in Asthma.,"Genetic variation may differentially modify drug and placebo treatment effects in randomized clinical trials. In asthma, although lung function and asthma control improvements are commonplace with placebo, pharmacogenomics of placebo vs. drug response remains unexamined. In a genomewide association study of subjective and objective outcomes with placebo treatment in Childhood Asthma Management Program of nedocromil/budesonide vs. placebo (N = 604), effect estimates for lead single nucleotide polymorphisms (SNPs) were compared across arms. The coughing/wheezing lead SNP, rs2392165 (β = 0.94; P = 1.10E-07) mapped to BBS9, a gene implicated in lung development that contains a lung function expression quantitative trait locus. The effect was attenuated with budesonide (P interaction = 1.48E-07), but not nedocromil (P interaction = 0.06). The lead forced vital capacity SNP, rs12930749 (β = -5.80; P = 1.47E-06), mapped to KIAA0556, a locus genomewide associated with respiratory diseases. The rs12930749 effect was attenuated with budesonide (P interaction = 1.32E-02) and nedocromil (P interaction = 1.09E-02). Pharmacogenomic analysis revealed differential effects with placebo and drug treatment that could potentially guide precision drug development in asthma.",2019,The rs12930749 effect was attenuated with budesonide (P interaction =1.32E-02) and nedocromil (P interaction =1.09E-02).,[],"['placebo', 'nedocromil', 'budesonide', 'nedocromil/budesonide versus placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068483', 'cui_str': 'Nedocromil'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}]",[],,0.212646,The rs12930749 effect was attenuated with budesonide (P interaction =1.32E-02) and nedocromil (P interaction =1.09E-02).,"[{'ForeName': 'Rui-Sheng', 'Initials': 'RS', 'LastName': 'Wang', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Damien C', 'Initials': 'DC', 'LastName': 'Croteau-Chonka', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Edwin K', 'Initials': 'EK', 'LastName': 'Silverman', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Loscalzo', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kathryn T', 'Initials': 'KT', 'LastName': 'Hall', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1646']
851,31719124,Ethical Issues in Newborn Sequencing Research: The Case Study of BabySeq.,"The BabySeq Project is a study funded by the National Institutes of Health and aimed at exploring the medical, behavioral, and economic impacts of integrating genomic sequencing into the care of both healthy newborns and newborns who are sick. Infants were randomly assigned to receive standard of care or standard of care plus sequencing. The protocol and consent specified that only childhood-onset conditions would be returned. When 1 child was found to carry a BRCA2 mutation despite a negative family history, the research team experienced moral distress about nondisclosure and sought institutional review board permission to disclose. The protocol was then modified to require participants to agree to receive results for adult-onset-only conditions as a precondition to study enrollment. The BabySeq team asserted that their new protocol was in the child's best interest because having one's parents alive and well provides both an individual child benefit and a ""family benefit."" We begin with a short description of BabySeq and the controversy regarding predictive genetic testing of children for adult-onset conditions. We then examine the ethical problems with (1) the revised BabySeq protocol and (2) the concept of family benefit as a justification for the return of adult-onset-only conditions. We reject family benefit as a moral reason to expand genomic sequencing of children beyond conditions that present in childhood. We also argue that researchers should design their pediatric studies to avoid, when possible, identifying adult-onset-only genetic variants and that parents should not be offered the return of this information if discovered unless relevant for the child's current or imminent health.",2019,"When 1 child was found to carry a BRCA2 mutation despite a negative family history, the research team experienced moral distress about nondisclosure and sought institutional review board permission to disclose.","['healthy newborns and newborns who are sick', 'Newborn Sequencing Research', 'children for adult-onset conditions']",['standard of care or standard of care plus sequencing'],[],"[{'cui': 'C0578757', 'cui_str': 'Good neonatal condition at birth (finding)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0035168'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],,0.0430357,"When 1 child was found to carry a BRCA2 mutation despite a negative family history, the research team experienced moral distress about nondisclosure and sought institutional review board permission to disclose.","[{'ForeName': 'Lainie Friedman', 'Initials': 'LF', 'LastName': 'Ross', 'Affiliation': 'MacLean Center for Clinical Medical Ethics and Departments of Pediatrics, Medicine, and Surgery, The University of Chicago, Chicago, Illinois; and lross@uchicago.edu.'}, {'ForeName': 'Ellen Wright', 'Initials': 'EW', 'LastName': 'Clayton', 'Affiliation': 'Department of Pediatrics, Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee.'}]",Pediatrics,['10.1542/peds.2019-1031']
852,32128848,The effects of acute and sustained cannabidiol dosing for seven days on the haemodynamics in healthy men: A randomised controlled trial.,"BACKGROUND
In vivo studies show that cannabidiol (CBD) acutely reduces blood pressure (BP) in men. The aim of this study was to assess the effects of repeated CBD dosing on haemodynamics.
METHODS
Twenty-six healthy males were given CBD (600 mg) or placebo orally for seven days in a randomised, placebo-controlled, double-blind, parallel study (n = 13/group). Cardiovascular parameters were assessed at rest and in response to isometric exercise after acute and repeated dosing using Finometer®, Vicorder® and Duplex ultrasound.
RESULTS
Compared to placebo, CBD significantly reduced resting mean arterial pressure (P = .04, two-way ANOVA, mean difference (MD) -2 mmHg, 95% CI -3.6 to -0.3) after acute dosing, but not after repeated dosing. In response to stress, volunteers who had taken CBD had lower systolic BP after acute (P = .001, two-way ANOVA, MD -6 mmHg, 95% CI -10 to -1) and repeated (P = .02, two-way ANOVA, MD -5.7 mmHg, 95% CI -10 to -1) dosing. Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01). Within the CBD group, repeated dosing reduced arterial stiffness by day 7 (pulse wave velocity; MD -0.44 m/s, P = .05) and improved endothelial function (flow mediation dilatation, MD +3.5%, P = .02, n = 6 per group), compared to day 1.
CONCLUSION
CBD reduces BP at rest after a single dose but the effect is lost after seven days of treatment (tolerance); however, BP reduction during stress persists. The reduction in arterial stiffness and improvements in endothelial function after repeated CBD dosing are findings that warrant further investigation in populations with vascular diseases.",2020,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","['Twenty-six healthy males', 'healthy men', 'men']","['placebo', 'CBD', 'placebo, CBD', 'cannabidiol (CBD']","['Cardiovascular parameters', 'BP reduction', 'systolic BP', 'blood pressure (BP', 'arterial stiffness', 'resting mean arterial pressure', 'internal carotid artery diameter', 'endothelial function']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",26.0,0.459438,"Seven days of CBD increased internal carotid artery diameter (MD +0.55 mm, P = .01).","[{'ForeName': 'Salahaden R', 'Initials': 'SR', 'LastName': 'Sultan', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Saoirse E', 'Initials': 'SE', 'LastName': ""O'Sullivan"", 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'England', 'Affiliation': 'Vascular Medicine, Division of Medical Sciences & Graduate Entry Medicine, School of Medicine, University of Nottingham, Royal Derby Hospital, Derby, UK.'}]",British journal of clinical pharmacology,['10.1111/bcp.14225']
853,31748254,Prenatal and Infancy Nurse Home Visiting and 18-Year Outcomes of a Randomized Trial.,"OBJECTIVES
Given earlier effects found in randomized clinical trials of the Nurse-Family Partnership, we examined whether this program would improve 18-year-old first-born youths' cognition, academic achievement, and behavior and whether effects on cognitive-related outcomes would be greater for youth born to mothers with limited psychological resources (LPR) and on arrests and convictions among females.
METHODS
We enrolled 742 pregnant, low-income women with no previous live births and randomly assigned them to receive either free transportation for prenatal care plus child development screening and referral (control; n = 514) or prenatal and infant home nurse visit (NV) plus transportation and screening ( n = 228). Assessments were completed on 629 18-year-old first-born offspring to evaluate these primary outcomes: (1) cognitive-related abilities (nonverbal intelligence, receptive language, and math achievement) and (2) behavioral health (internalizing behavioral problems, substance use and abuse, sexually transmitted infections, HIV risk, arrests, convictions, and gang membership).
RESULTS
Compared with control-group counterparts, NV youth born to mothers with LPR had better receptive language (effect size = 0.24; 95% confidence interval [CI]: 0.00 to 0.47; P = .05), math achievement (effect size = 0.38; 95% CI: 0.14 to 0.61; P = .002), and a number of secondary cognitive-related outcomes. NV females, as a trend, had fewer convictions (incidence ratio = 0.47; 95% CI: 0.20 to 1.11; P = .08). There were no intervention effects on other behaviors.
CONCLUSIONS
The program improved the cognitive-related skills of 18-year-olds born to mothers with LPR and, as a trend, reduced female convictions but produced no other effects on youth behavioral health.",2019,"NV females, as a trend, had fewer convictions (incidence ratio = 0.47; 95% CI: 0.20 to 1.11; P = .08).","['742 pregnant, low-income women with no previous live births', 'youth born to mothers with limited psychological resources (LPR) and on arrests and convictions among females']",['free transportation for prenatal care plus child development screening and referral (control; n = 514) or prenatal and infant home nurse visit (NV) plus transportation and screening'],"['cognitive-related abilities (nonverbal intelligence, receptive language, and math achievement) and (2) behavioral health (internalizing behavioral problems, substance use and abuse, sexually transmitted infections, HIV risk, arrests, convictions, and gang membership', 'math achievement', 'cognitive-related skills', 'receptive language', 'youth behavioral health']","[{'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3165395', 'cui_str': 'Screening for child development'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0237477', 'cui_str': 'Arrested (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",742.0,0.115765,"NV females, as a trend, had fewer convictions (incidence ratio = 0.47; 95% CI: 0.20 to 1.11; P = .08).","[{'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Kitzman', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Olds', 'Affiliation': 'Departments of Pediatrics and david.olds@cuanschutz.edu.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Knudtson', 'Affiliation': 'Departments of Pediatrics and.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Cole', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Anson', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'School of Nursing, University of Rochester, Rochester, New York.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Fishbein', 'Affiliation': 'Edna Bennett Pierce Prevention Research Center, Pennsylvania State University, State College, Pennsylvania.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DiClemente', 'Affiliation': 'College of Global Public Health, New York University, New York, New York.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Wingood', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, New York.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Caliendo', 'Affiliation': 'Warren Alpert Medical School, Brown University, Providence, Rhode Island.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hopfer', 'Affiliation': 'Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Miller', 'Affiliation': 'Pacific Institute for Research and Evaluation and School of Public Health, Curtin University, Beltsville, Maryland; and.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Conti', 'Affiliation': 'Departments of Economics and Social Science, University College London, London, United Kingdom.'}]",Pediatrics,['10.1542/peds.2018-3876']
854,32432384,Internet-based interpretation bias modification for body dissatisfaction: A three-armed randomized controlled trial.,"OBJECTIVE
Appearance-related interpretation bias is postulated to play a role in the maintenance of body dissatisfaction (BD), a risk factor for body dysmorphic disorder (BDD), and eating disorders (ED). Cognitive bias modification for interpretation (CBM-I) has been shown to reduce maladaptive interpretation bias and symptoms in various emotional disorders. This study investigated the acceptability and efficacy of an easily disseminable, web-based CBM-I program for BD.
METHODS
Individuals with high BD (N = 318) were randomized to a multi-session CBM-I (Sentence Word Association Paradigm [SWAP] with feedback) vs. control (SWAP without feedback) versus waitlist condition. Interpretation bias, BD and associated symptoms were assessed at baseline and post-intervention. Symptoms were monitored up to 1-week and 4-week follow-up. We further investigated transference effects to stress reactivity, as predicted by cognitive-behavioral models, at post-intervention.
RESULTS
Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18). Both CBM-I and control training reduced BD, BDD symptom severity, and depression. However, CBM-I (vs. control and waitlist) improved appearance-related quality of life (d = 0.51), self-esteem (d = 0.52), and maladaptive appearance-related beliefs (d = 0.47). State stress reactivity was overall reduced in the CBM-I condition (vs. waitlist). Intervention effects largely held stable up to follow-ups. Treatment satisfaction was comparable to other CBM-I studies, with low rates of adverse reactions.
DISCUSSION
These findings support assumptions of cognitive-behavioral models for BD, BDD, and ED, and suggest that web-based CBM-I is an efficacious and acceptable intervention option.",2020,"Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18).",['Individuals with high BD (N = 318'],"['multi-session CBM-I (Sentence Word Association Paradigm [SWAP] with feedback) vs. control (SWAP without feedback) versus waitlist condition', 'Internet-based interpretation bias modification']","['BD, BDD symptom severity, and depression', 'State stress reactivity', 'Treatment satisfaction', 'maladaptive appearance-related beliefs', 'self-esteem', 'acceptability and efficacy', 'appearance-related quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0459471', 'cui_str': 'Interpretation'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",318.0,0.0516419,"Appearance-related CBM-I led to a differential pre-post increase in adaptive interpretation patterns, particularly for appearance-related and social situations (d = 0.65-1.18).","[{'ForeName': 'Fanny Alexandra', 'Initials': 'FA', 'LastName': 'Dietel', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Zache', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Paul-Christian', 'Initials': 'PC', 'LastName': 'Bürkner', 'Affiliation': 'Department of Computer Science, Aalto University, Espoo, Finland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schulte', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Möbius', 'Affiliation': 'Behavioral Science Institute, Radboud University Nijmegen, Nijmegen, The Netherlands.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Bischof', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Buhlmann', 'Affiliation': 'Clinical Psychology and Psychotherapy, Department of Psychology, Westfälische Wilhelms-Universität, Muenster, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23280']
855,31718391,"Re: ""Annurca Apple Nutraceutical Formulation Enhances Keratin Expression in a Human Model of Skin and Promotes Hair Growth and Tropism in a Randomized Clinical Trial"" by Tenore et al. ( J Med Food 2018;21:90-103).",,2019,,[],[],[],[],[],[],,0.0238007,,"[{'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Keith', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Department of Applied Health Science, School of Public Health, Indiana University-Bloomington, Bloomington, Indiana, USA.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social and Health Sciences, Clemson University, Clemson, South Carolina, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Heymsfield', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Indiana University-Bloomington, Bloomington, Indiana, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0220']
856,32428341,"Changing Sedentary Behavior in the Office: A Randomised Controlled Trial Comparing the Effect of Affective, Instrumental, and Self-Regulatory Messaging on Sitting.","BACKGROUND
Although avoiding sedentary behavior has many health benefits, adults often sit for long periods at work. The purpose of this study was to compare affective attitude, instrumental attitude, and self-regulation messaging interventions on sitting in the workplace.
METHODS
Using a cluster randomised controlled trial design, participants (N = 116) were assigned (by workplace) to: (a) instrumental, (b) affective, (c) self-regulation, or (d) control (nutrition information) groups. Measurements were taken online at baseline, 4 weeks, 8 weeks, and 12 weeks post-baseline. The interventions comprised three presentations delivered following baseline, week 4, and week 8 assessments. The primary outcome was self-reported average hours of sitting per day at work (registered trial number: NCT04082624).
RESULTS
Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups. Also, at week 4, the affective group sat for less time than the instrumental and self-regulation groups and, at week 8, the affective group sat for less time than the self-regulation and control groups. There were no differences between the groups at week 12.
CONCLUSIONS
This investigation showed that workplace interventions targeting affective attitude can lead to less sitting time in the short term. Future research should explore additional strategies to minimise sedentary behavior in the long term.",2020,"RESULTS
Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups.",['participants (N\xa0=\xa0116'],[],"['sitting time', 'self-reported average hours of sitting per day at work (registered trial number: NCT04082624']","[{'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",116.0,0.0563669,"RESULTS
Controlling for baseline sitting, overall, the affective group sat for less time than the instrumental and self-regulation groups.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lithopoulos', 'Affiliation': 'University of Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Kaushal', 'Affiliation': 'Indiana University, Indianapolis, IN, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Conner', 'Affiliation': 'University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'de Bruijn', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Latimer-Cheung', 'Affiliation': ""Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'University of Victoria, Victoria, BC, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12202']
857,31869281,Essential Ingredients and Innovations in the Design and Analysis of Group-Randomized Trials.,"This article reviews the essential ingredients and innovations in the design and analysis of group-randomized trials. The methods literature for these trials has grown steadily since they were introduced to the biomedical research community in the late 1970s, and we summarize those developments. We review, in addition to the group-randomized trial, methods for two closely related designs, the individually randomized group treatment trial and the stepped-wedge group-randomized trial. After describing the essential ingredients for these designs, we review the most important developments in the evolution of their methods using a new bibliometric tool developed at the National Institutes of Health. We then discuss the questions to be considered when selecting from among these designs or selecting the traditional randomized controlled trial. We close with a review of current methods for the analysis of data from these designs, a case study to illustrate each design, and a brief summary.",2020,"The methods literature for these trials has grown steadily since they were introduced to the biomedical research community in the late 1970s, and we summarize those developments.",[],[],[],[],[],[],,0.183815,"The methods literature for these trials has grown steadily since they were introduced to the biomedical research community in the late 1970s, and we summarize those developments.","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Murray', 'Affiliation': 'Office of Disease Prevention, National Institutes of Health, North Bethesda, Maryland 20892, USA; email: david.murray2@nih.gov, stephanie.george@nih.gov.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Civic Campus, Ottawa, Ontario K1Y 4E9, Canada; email: mtaljaard@ohri.ca.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, and Duke Global Health Institute, Duke University, Durham, North Carolina 27710, USA; email: liz.turner@duke.edu.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'George', 'Affiliation': 'Office of Disease Prevention, National Institutes of Health, North Bethesda, Maryland 20892, USA; email: david.murray2@nih.gov, stephanie.george@nih.gov.'}]",Annual review of public health,['10.1146/annurev-publhealth-040119-094027']
858,31990414,Sonidegib and vismodegib in the treatment of patients with locally advanced basal cell carcinoma: a joint expert opinion.,"Sonidegib and vismodegib are hedgehog pathway inhibitors (HhIs) approved for the treatment of advanced basal cell carcinoma (BCC). Until recently, vismodegib was the only targeted treatment available for patients with locally advanced BCC (laBCC) in cases where surgery and radiotherapy are inappropriate. Sonidegib has recently been approved and now presents an alternative treatment option. The clinical differences between the two HhIs in patients with laBCC are unclear, as no head-to-head randomized controlled trials are or will be initiated. Moreover, there were important differences in the designs of their pivotal studies, BOLT (sonidegib) and ERIVANCE (vismodegib), and these differences complicate evidence-based analysis of their relative efficacy and safety profiles. In this paper, a group of clinical experts in the management of laBCC summarizes the clinical and pharmacological profiles of sonidegib and vismodegib based on published data and their own clinical experience. One key difference between the two pivotal studies was the criteria used to assess BCC severity. ERIVANCE (a single-arm phase II trial) used the conventional Response Evaluation Criteria in Solid Tumors (RECIST), while the more recent double-blind randomized BOLT trial used the stringent modified RECIST. A preplanned analysis adjusted the outcomes from BOLT with RECIST-like criteria, and this enabled the experts to discuss relative efficacy outcomes for the two treatments. Centrally reviewed objective response rate (ORR) for vismodegib was 47.6% (95% CI: 35.5-60.6) at 21-month follow-up using RECIST. After adjusting with RECIST-like criteria, the ORR for sonidegib according to central review at 18-month follow-up was 60.6% (95% CI: 47.8-72.4). Both treatments were associated with similar patterns of adverse events. Sonidegib and vismodegib share the same efficacy and tolerability profiles, but their pharmacokinetic profiles show several differences, such as volume of distribution and half-life. Further studies are needed to understand how these differences may impact clinical practice.",2020,Centrally reviewed objective response rate (ORR) for vismodegib was 47.6% (95% CI 35.5-60.6) at 21-month follow-up using RECIST.,"['patients with locally advanced basal cell carcinoma', 'advanced basal cell carcinoma (BCC', 'patients with locally advanced BCC (laBCC']","['Sonidegib and vismodegib', 'conventional Response Evaluation Criteria in Solid Tumors (RECIST']","['objective response rate (ORR', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3886731', 'cui_str': 'sonidegib'}, {'cui': 'C2987716', 'cui_str': 'vismodegib'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0754951,Centrally reviewed objective response rate (ORR) for vismodegib was 47.6% (95% CI 35.5-60.6) at 21-month follow-up using RECIST.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Melanoma, Cancer Immunotherapy and Development Therapeutics Unit, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Basset-Seguin', 'Affiliation': 'Department of Dermatology, Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dréno', 'Affiliation': 'Department of Dermato Oncology, University Hospital Nantes, Nantes, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Division of Dermato-oncology, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hauschild', 'Affiliation': 'Department of Dermatology, University Hospital Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Krattinger', 'Affiliation': 'Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Lear', 'Affiliation': 'Department of Dermatology, Manchester Academic Health Science Centre, Manchester University and Salford Royal NHS Trust, Manchester, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Malvehy', 'Affiliation': 'Dermatology Department, Hospital Clinic of Barcelona, IDIBAPS, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital Essen, Essen & German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Dermatology and Oncology Service, Aix Marseille University and Timone Hospital, Marseille, France.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16230']
859,32428227,The role of the inferior parietal lobule in writer's cramp.,"Humans have a distinguishing ability for fine motor control that is subserved by a highly evolved cortico-motor neuronal network. The acquisition of a particular motor skill involves a long series of practice movements, trial and error, adjustment and refinement. At the cortical level, this acquisition begins in the parieto-temporal sensory regions and is subsequently consolidated and stratified in the premotor-motor cortex. Task-specific dystonia can be viewed as a corruption or loss of motor control confined to a single motor skill. Using a multimodal experimental approach combining neuroimaging and non-invasive brain stimulation, we explored interactions between the principal nodes of the fine motor control network in patients with writer's cramp and healthy matched controls. Patients and healthy volunteers underwent clinical assessment, diffusion-weighted MRI for tractography, and functional MRI during a finger tapping task. Activation maps from the task-functional MRI scans were used for target selection and neuro-navigation of the transcranial magnetic stimulation. Single- and double-pulse TMS evaluation included measurement of the input-output recruitment curve, cortical silent period, and amplitude of the motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation in a randomized, sham-controlled design. Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions were facilitatory and inhibitory, respectively, in healthy volunteers, whereas the interactions were converse and significantly different in writer's cramp. Baseline PMv-M1 interactions were inhibitory and similar between the groups. The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed. Cortical silent period was significantly prolonged in writer's cramp. Making a long term depression-like plastic change to dIPL node transformed the aIPL-M1 interaction to inhibitory (similar to healthy volunteers) and cancelled the PMv-M1 inhibition only in the writer's cramp group. These findings suggest that the parietal multimodal sensory association region could have an aberrant downstream influence on the fine motor control network in writer's cramp, which could be artificially restored to its normal function.",2020,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[""patients with writer's cramp and healthy matched controls"", ""writer's cramp"", 'Patients and healthy volunteers', 'healthy volunteers']","['motor evoked potentials conditioned by cortico-cortical interactions between premotor ventral (PMv)-motor cortex (M1), anterior inferior parietal lobule (aIPL)-M1, and dorsal inferior parietal lobule (dIPL)-M1 before and after inducing a long term depression-like plastic change to dIPL node with continuous theta-burst transcranial magnetic stimulation', 'multimodal experimental approach combining neuroimaging and non-invasive brain stimulation', 'Single- and double-pulse TMS']","['structural connectivity', 'Baseline dIPL-M1 and aIPL-M1 cortico-cortical interactions', 'dIPL-PMv resting state functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0154676', 'cui_str': ""Organic writer's cramp""}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032167', 'cui_str': 'Plastic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0232120', 'cui_str': 'Double pulse'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0340364', 'cui_str': 'Familial mitral valve prolapse'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0317236,"The dIPL-PMv resting state functional connectivity was increased in patients compared to controls, but no differences in structural connectivity between the nodes were observed.","[{'ForeName': 'Shabbir Hussain I', 'Initials': 'SHI', 'LastName': 'Merchant', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Frangos', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Bradson', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Vial-Undurraga', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Leodori', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Bushnell', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Silvina G', 'Initials': 'SG', 'LastName': 'Horovitz', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Traian', 'Initials': 'T', 'LastName': 'Popa', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa138']
860,31553693,"High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008.","PURPOSE
The R2Pulm trial was conducted to evaluate the effect of busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI) on event-free survival (main end point) and overall survival, compared with standard chemotherapy with WLI in Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases.
METHODS
From 2000 to 2015, we enrolled patients younger than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases. Patients received chemotherapy with six courses of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI) by randomized assignment. The analysis was conducted as intention to treat. The estimates of the hazard ratio (HR), 95% CI, and P value were corrected for the three previous interim analyses by the inverse normal method.
RESULTS
Of 543 potentially eligible patients, 287 were randomly assigned to VAI plus WLI (n = 143) or BuMel (n = 144). Selected patients requiring radiotherapy to an axial primary site were excluded from randomization to avoid excess organ toxicity from interaction between radiotherapy and busulfan. Median follow-up was 8.1 years. We did not observe any significant difference in survival outcomes between treatment groups. Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16). For overall survival, the HR was 1.00 (95% CI, 0.70 to 1.44; P = .99). Four patients died as a result of BuMel-related toxicity, and none died after VAI plus WLI. Significantly more patients in the BuMel arm experienced severe acute toxicities than in the VAI plus WLI arm.
CONCLUSION
In ES with pulmonary or pleural metastases, there is no clear benefit from BuMel compared with conventional VAI plus WLI.",2019,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16).","['Ewing sarcoma (ES) presenting with pulmonary and/or pleural metastases', 'From 2000 to 2015, we enrolled patients older than 50 years of age with newly diagnosed ES and with only pulmonary or pleural metastases', 'Ewing Sarcoma', 'Selected patients requiring radiotherapy to an axial primary site', 'Of 543 potentially eligible patients']","['standard chemotherapy with WLI', 'busulfan-melphalan high-dose chemotherapy with autologous stem-cell rescue (BuMel) without whole-lung irradiation (WLI', 'Standard Chemotherapy and Lung Radiation', 'radiotherapy and busulfan', 'chemotherapy', 'High-Dose Chemotherapy', 'BuMel', 'vincristine, ifosfamide, doxorubicin, and etoposide (VIDE) and one course of vincristine, dactinomycin, and ifosfamide (VAI) before either BuMel or seven courses of VAI and WLI (VAI plus WLI', 'VAI plus WLI']","['severe acute toxicities', 'Event-free survival', 'survival outcomes', 'overall survival', 'hazard ratio (HR']","[{'cui': 'C0553580', 'cui_str': ""Ewing's Tumor""}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0153678', 'cui_str': 'Secondary malignant neoplasm of pleura (disorder)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",287.0,0.239424,"Event-free survival was 50.6% versus 56.6% at 3 years and 43.1% versus 52.9% at 8 years, for VAI plus WLI and BuMel patients, respectively, resulting in an HR of 0.79 (95% CI, 0.56 to 1.10; P = .16).","[{'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Dirksen', 'Affiliation': 'University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Brennan', 'Affiliation': ""Royal Manchester Children's Hospital, Manchester, United Kingdom.""}, {'ForeName': 'Marie-Cécile', 'Initials': 'MC', 'LastName': 'Le Deley', 'Affiliation': 'Centre Oscar Lambret, Lille; and Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Cozic', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'van den Berg', 'Affiliation': 'Emma Children Hospital - Amsterdam University Medical Centres, Amsterdam, the Netherlands.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Bhadri', 'Affiliation': ""Chris O'Brien Lifehouse, Camperdown, NSW, Australia.""}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Brichard', 'Affiliation': 'Cliniques Universitaires Saint Luc, Brussels, Belgium.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Claude', 'Affiliation': 'Centre Léon Bérard, Lyon; France.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Craft', 'Affiliation': 'Northern Institute for Cancer Research, Newcastle Upon Tyne, United Kingdom.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Amler', 'Affiliation': 'Westfalian Wilhelms University Muenster, Muenster; and Friedrich- Loeffler Institute, Greifswald-Insel Riems, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Goldsby', 'Affiliation': ""University of California San Francisco Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gorlick', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Holcombe E', 'Initials': 'HE', 'LastName': 'Grier', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Guinbretiere', 'Affiliation': 'Hôpital René-Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hauser', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Hjorth', 'Affiliation': 'Lund University, Lund, Sweden.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Janeway', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorder Center, Boston, MA.""}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Juergens', 'Affiliation': 'Universitaetskinderklinik Muenster, Muenster, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'Royal Marsden Foundation NHS Trust, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Krailo', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Jarmila', 'Initials': 'J', 'LastName': 'Kruseova', 'Affiliation': 'Charles University Prague, Czech Republic.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kuehne', 'Affiliation': ""University Children's Hospital Basel, Basel, Switzerland.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ladenstein', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Lervat', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Lessnick', 'Affiliation': ""Nationwide Children's Hospital and The Ohio State University College of Medicine, Columbus, OH.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Lewis', 'Affiliation': 'University of Leeds, Liverpool, United Kingdom.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Linassier', 'Affiliation': 'Centre Hospitalier Universitaire, Tours, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Marec-Berard', 'Affiliation': 'Institute of Pediatric Onco-Haematology, Lyon, France.'}, {'ForeName': 'Neyssa', 'Initials': 'N', 'LastName': 'Marina', 'Affiliation': 'Five Time Therapeutics, South San Francisco, CA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Morland', 'Affiliation': ""Birmingham Women and Children's Hospital, Birmingham, United Kingdom.""}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pacquement', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paulussen', 'Affiliation': 'Witten/Herdecke University, Datteln, Germany.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'University of California Davis, Sacramento, CA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ranft', 'Affiliation': 'Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Gwénaël', 'Initials': 'G', 'LastName': 'Le Teuff', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wheatley', 'Affiliation': 'University College Hospital, London, United Kingdom.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Whelan', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Womer', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Oberlin', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00915']
861,32119790,Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Based on Total Daily Insulin in Adolescents with Type 1 Diabetes.,"Objective: To assess the safety and efficacy of a simplified initialization for the Tandem t:slim X2 Control-IQ hybrid closed-loop system, using parameters based on total daily insulin (""MyTDI"") in adolescents with type 1 diabetes under usual activity and during periods of increased exercise. Research Design and Methods: Adolescents with type 1 diabetes 12-18 years of age used Control-IQ for 5 days at home using their usual parameters. Upon arrival at a 60-h ski camp, participants were randomized to either continue Control-IQ using their home settings or to reinitialize Control-IQ with MyTDI parameters. Control-IQ use continued for 5 days following camp. The effect of MyTDI on continuous glucose monitoring outcomes were analyzed using repeated measures analysis of variance (ANOVA): baseline, camp, and at home. Results: Twenty participants were enrolled and completed the study; two participants were excluded from the analysis due to absence from ski camp (1) and illness (1). Time in range was similar between both groups at home and camp. A tendency to higher time <70 mg/dL in the MyTDI group was present but only during camp (median 3.8% vs. 1.4%, P = 0.057). MyTDI users with bolus/TDI ratios >40% tended to show greater time in the euglycemic range improvements between baseline and home than users with ratios <40% (+16.3% vs. -9.0%, P = 0.012). All participants maintained an average of 95% time in closed loop (84.1%-100%). Conclusions: MyTDI is a safe, effective, and easy way to determine insulin parameters for use in the Control-IQ artificial pancreas. Future modifications to account for the influence of carbohydrate intake on MyTDI calculations might further improve time in range.",2020,"MyTDI is a safe, effective, and easy way to determine insulin parameters for use in the Control-IQ artificial pancreas.","['Adolescents with Type 1 Diabetes', 'adolescents with type 1 diabetes under usual activity and during periods of increased exercise', 'Results: Twenty participants were enrolled and completed the study; two participants were excluded from the analysis due to absence from ski camp (1) and illness (1', 'Adolescents with type 1 diabetes 12-18 years of age used Control-IQ for 5 days at home using their usual parameters']","['Initializing the Control-IQ Artificial Pancreas System', 'simplified initialization for the Tandem t:slim X2 Control-IQ hybrid closed-loop system, using parameters based on total daily insulin (""MyTDI']","['euglycemic range improvements', 'continuous glucose monitoring outcomes', 'Safety and Efficacy', 'safety and efficacy']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0037262', 'cui_str': 'SKI (body structure)'}, {'cui': 'C0012054', 'cui_str': ""N',O'-Dibutyryl-cAMP""}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2004457', 'cui_str': 'Artificial (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2.0,0.0552424,"MyTDI is a safe, effective, and easy way to determine insulin parameters for use in the Control-IQ artificial pancreas.","[{'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Schoelwer', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Robic', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Gautier', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Fabris', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Carr', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Clancy-Oliveri', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Stacey M', 'Initials': 'SM', 'LastName': 'Anderson', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Cherñavvsky', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0471']
862,32026103,The CLEAR (Considering Leading Experts' Antithrombotic Regimes around peripheral angioplasty) survey: an international perspective on antiplatelet and anticoagulant practice for peripheral arterial endovascular intervention.,"BACKGROUND
Antiplatelet and anticoagulant therapy are commonly used before, during and after peripheral arterial endovascular intervention. This survey aimed to establish antiplatelet and anticoagulant choice for peripheral arterial endovascular intervention in contemporary clinical practice.
METHODS
Pilot-tested questionnaire distributed via collaborative research networks.
RESULTS
One hundred and sixty-two complete responses were collected from responders in 22 countries, predominantly the UK (48%) and the rest of the European Union (44%). Antiplatelet monotherapy was the most common choice pre-procedurally (62%). In the UK, there was no difference between dual and single antiplatelet therapy use post procedure (50% vs. 37% p = 0.107). However, a significant majority of EU respondents used dual therapy (68% vs. 20% p < 0.001). There was variation in choice of antiplatelet therapy by the device used and the anatomical location of the intervention artery. The majority (82%) of respondents believed there was insufficient evidence to guide antithrombotic therapy after peripheral endovascular intervention and most (92%) would support a randomised trial.
CONCLUSIONS
There is widespread variation in the use of antiplatelet therapy, especially post peripheral arterial endovascular intervention. Clinicians would support the development of a randomised trial comparing dual antiplatelet therapy with monotherapy.",2019,"However, a significant majority of EU respondents used dual therapy (68% vs. 20% p < 0.001).",[],['Antiplatelet monotherapy'],[],[],[],[],,0.103113,"However, a significant majority of EU respondents used dual therapy (68% vs. 20% p < 0.001).","[{'ForeName': 'Kitty H F', 'Initials': 'KHF', 'LastName': 'Wong', 'Affiliation': 'Bristol Centre for Surgical Research, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Dave C', 'Initials': 'DC', 'LastName': 'Bosanquet', 'Affiliation': 'North Bristol NHS Trust, Southmead Hospital, Southmead Road, Bristol, BS10 5NB, UK.'}, {'ForeName': 'Graeme K', 'Initials': 'GK', 'LastName': 'Ambler', 'Affiliation': 'Bristol Centre for Surgical Research, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Mahim I', 'Initials': 'MI', 'LastName': 'Qureshi', 'Affiliation': 'Bristol Centre for Surgical Research, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hinchliffe', 'Affiliation': 'Bristol Centre for Surgical Research, University of Bristol, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Twine', 'Affiliation': 'Bristol Centre for Surgical Research, University of Bristol, Bristol, BS8 2PS, UK. chris_twine@hotmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CVIR endovascular,['10.1186/s42155-019-0079-8']
863,32427675,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION
Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability.
METHODS
Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT.
RESULTS
There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT.
DISCUSSION
FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661']
864,31872894,Does adoption of an evidence-based practice lead to job turnover? Results from a randomized trial.,"It is important to understand the impact of implementation of evidence-based practices (EBPs) on the workforce. EBP implementation can increase job demands, stress, and burnout, and may thereby exacerbate turnover. This study examined the effects of implementation of an EBP on turnover among staff at nine child welfare agencies. A total of 102 providers were randomized to either adopt an EBP, SafeCare © , or continue providing services as usual. Participants completed a baseline survey assessing demographics, attitudes toward EBPs, and organizational functioning, and provider turnover was recorded for up to 18 months following implementation. The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]). Variables associated with turnover included age (OR = 0.92), years since degree completion (OR = 0.94), prior exposure to EBP (OR = 3.91), believing that adopting an EBP was burdensome (OR = 0.52), and motivation for change (OR = 0.89). EBP assignment moderated two aspects of negative attitudes toward EBP (divergence and monitoring) to predict turnover; those attitudes were only positively related to turnover for individuals assigned to the EBP (OR = 1.46, 1.16). Implications of the findings for implementation are discussed.",2020,"The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]).",['A total of 102 providers'],"['EBP implementation', 'EBP, SafeCare © , or continue providing services as usual', 'EBP']","['overall turnover rate', 'baseline survey assessing demographics, attitudes toward EBPs, and organizational functioning, and provider turnover']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0301051,"The overall turnover rate was 35%, but did not differ by EBP assignment (odds ratio [OR] = 1.27; 95% confidence interval [0.66, 2.45]).","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Weeks', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Self-Brown', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'Zahidi', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia.'}]",Journal of community psychology,['10.1002/jcop.22305']
865,17973947,Effect of progestins with different glucocorticoid activity on bone metabolism.,"OBJECTIVE
Progestins are commonly prescribed for hormone replacement therapy (HRT) and contraception. However, the effects of progestins on bone metabolism remain unclear and are often controversial.
DESIGN AND PATIENTS
This study was conducted to test the hypothesis that progestins with no significant glucocorticoid activity may be a better choice for HRT to achieve increased beneficial effects on bone metabolism than progestins with strong glucocorticoid activity. A total of 104 postmenopausal women aged 50-75 years with osteoporosis were allocated randomly to three groups: (1) conjugated oestrogen plus medroxyprogesterone acetate (HRT-MPA, with significant glucocorticoid activity); (2) conjugated oestrogen plus norethisterone (HRT-NET, with no significant glucocorticoid activity); and (3) control (no treatment).
MEASUREMENTS
Vertebral X-rays and bone mineral density (BMD) at distal 1/3 radius were assessed at baseline and every 6 months during the 2-year study period, along with markers of bone turnover. The occurrence of new nonvertebral fractures was identified by X-ray.
RESULTS
After the 2-year treatment, mean BMD changes relative to baseline in the HRT-MPA, HRT-NET and control groups were 1.6%, 2.3% and -1.9%, respectively. In addition, the rate of increase in HRT-NET was significantly greater than that in HRT-MPA (P = 0.019). The incidence of new fractures during the 2-year treatment in the control group was 26% (9/34). HRT-NET treatment significantly inhibited the occurrence of new fractures (RR 0.14, 95% CI 0.02-0.93, P = 0.04), while HRT-MPA treatment failed to show a statistically significant reduction (RR 0.41, 95% CI 0.14-1.24, P = 0.11). Both HRT-MPA and HRT-NET treatments significantly decreased serum osteocalcin levels by 29.4% and 23.5%, respectively, after 6 months of treatment, with the decrease in HRT-MPA being significantly greater than that in HRT-NET (P = 0.042).
CONCLUSIONS
These findings suggest that progestins with no significant glucocorticoid activity may be a better choice for HRT, resulting in increased beneficial effects on bone metabolism compared with progestins with strong glucocorticoid activity.",2008,The incidence of new fractures during the 2-year treatment in the control group was 26% (9/34).,['104 postmenopausal women aged 50-75 years with osteoporosis'],"['conjugated oestrogen plus medroxyprogesterone acetate (HRT-MPA, with significant glucocorticoid activity); (2) conjugated oestrogen plus norethisterone (HRT-NET, with no significant glucocorticoid activity); and (3) control (no treatment', 'progestins', 'HRT-MPA and HRT-NET', 'HRT-NET', 'progestins with different glucocorticoid activity']","['incidence of new fractures', 'bone metabolism', 'HRT-MPA', 'serum osteocalcin levels', 'rate of increase in HRT-NET', 'occurrence of new fractures', 'Vertebral X-rays and bone mineral density (BMD', 'mean BMD changes relative']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028356', 'cui_str': 'norethisterone'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",104.0,0.0332081,The incidence of new fractures during the 2-year treatment in the control group was 26% (9/34).,"[{'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Ishida', 'Affiliation': 'Department of Orthopaedic Surgery, Yamaguchi University Graduate School of Medicine, Yamaguchi, Japan. myishida@yamaguchi-u.ac.jp'}, {'ForeName': 'Takatomo', 'Initials': 'T', 'LastName': 'Mine', 'Affiliation': ''}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Taguchi', 'Affiliation': ''}]",Clinical endocrinology,[]
866,31473291,A Randomized Controlled Trial of Interventions for Growth Suppression in Children With Attention-Deficit/Hyperactivity Disorder Treated With Central Nervous System Stimulants.,"OBJECTIVE
To examine the impact of central nervous system (CNS) stimulants on the growth of children with attention-deficit/hyperactivity disorder (ADHD), and to assess the efficacy and feasibility of weight recovery interventions on growth.
METHOD
A total of 230 children aged 5 to 12 years with ADHD with no history of chronic CNS stimulant use were randomly assigned to receive daily CNS stimulants (78%, primarily osmotic release oral system-methylphenidate [OROS-MPH]) or behavioral treatment (22%) for 30 months. After 6 months, children evidencing a decline in body mass index (BMI) of >0.5 z-units were randomized to 1 of 3 weight recovery treatments (WRTs): monthly monitoring of height/weight (MON) plus continued daily medication; drug holidays (DH) with medication limited to school days; or daily caloric supplementation (CS) with a 150-kcal supplement plus daily medication.
RESULTS
Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p values <.01). Adherence to CS and DH during WRT was high, with significant increases in daily caloric intake and decreases in weekly medication exposure (p values <.05). Across all WRT participants (n = 71), weight velocity increased significantly after WRT randomization (β 2 = 0.271, SE = 0.027, p < .001).When analyzed by what parents did (versus what they were assigned to), CS (p < .01) and DH (p < .05) increased weight velocity more than MON. No increase in height velocity was seen after randomization to any WRT. Over the entire study, WRT participants declined in standardized weight (-0.44 z-units) and height (-0.20 z-units).
CONCLUSION
Drug holidays, caloric supplementation, and increased monitoring all led to increased weight velocity in children taking CNS stimulants, but none led to increased height velocity.
CLINICAL TRIAL REGISTRATION INFORMATION
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth; https://clinicaltrials.gov/; NCT01109849.",2020,"Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p's<.01).","['children with attention-deficit/hyperactivity disorder (ADHD', '230 children ages 5-12 with ADHD with no history of chronic CNS stimulant usage', 'Children With Attention-Deficit/Hyperactivity Disorder']","['daily CNS stimulants', 'weight recovery treatments (WRTs): monthly monitoring of height/weight (MON) plus continued daily medication, drug holidays (DH) with medication limited to school days, or daily caloric supplementation (CS) with a 150-kcal supplement plus daily medication', 'central nervous system (CNS) stimulants', 'Central Nervous System Stimulants', 'primarily OROS-Methylphenidate [OROS-MPH]) or behavioral treatment']","['weight velocity', 'body mass index (BMI', ""standardized weight and height (p's<.01"", 'height velocity', 'daily caloric intake']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0019843', 'cui_str': 'Holidays'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3544299', 'cui_str': 'Caloric supplementation'}, {'cui': 'C0050286', 'cui_str': 'A 150 (plastic)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0002763', 'cui_str': 'Central Stimulants'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}]","[{'cui': 'C0455808', 'cui_str': 'Weight velocity (observable entity)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",230.0,0.183562,"Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p's<.01).","[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Waxmonsky', 'Affiliation': 'Penn State College of Medicine, Hershey, Pennsylvania. Electronic address: jwaxmonsky@pennstatehealth.psu.edu.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Arizona State University, Tempe.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Campa', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, Miami.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Waschbusch', 'Affiliation': 'Penn State College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, Miami.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Marshall', 'Affiliation': 'Herbert Wertheim College of Medicine, Florida International University, Miami.'}, {'ForeName': 'Lysett', 'Initials': 'L', 'LastName': 'Babocsai', 'Affiliation': 'University of Heidelberg, Germany.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Humphery', 'Affiliation': 'Herbert Wertheim College of Medicine, Florida International University, Miami.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Gnagy', 'Affiliation': 'Florida International University, Miami.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Swanson', 'Affiliation': 'School of Medicine, University of California, Irvine.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Hanć', 'Affiliation': 'Adam Mickiewicz University, Poznan, Poland.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Fallahazad', 'Affiliation': 'Robert Stempel College of Public Health and Social Work, Florida International University, Miami.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Pelham', 'Affiliation': 'Florida International University, Miami.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.08.472']
867,31925817,"First-in-human clinical trial to assess the safety, tolerability and pharmacokinetics of P218, a novel candidate for malaria chemoprotection.","AIMS
This first-in-human clinical trial of P218, a novel dihydrofolate reductase inhibitor antimalarial candidate, assessed safety, tolerability, pharmacokinetics and food effects in healthy subjects.
METHODS
The study consisted of two parts. Part A was a double-blind, randomized, placebo-controlled, parallel group, ascending dose study comprising seven fasted cohorts. Eight subjects/cohort were randomized (3:1) to receive either a single oral dose of P218 (10, 30, 100, 250, 500, 750 and 1000 mg) or placebo. Part B was an open-label, cross-over, fed/fasted cohort (eight subjects) that received a 250 mg single dose of P218 in two treatment periods.
RESULTS
P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects. Nine adverse events in five subjects, all of mild intensity, were judged drug related. No clinically relevant abnormalities in ECG, vital signs or laboratory tests changes were observed. P218 was rapidly absorbed, with C max achieved between 0.5 and 2 hours post dose. Plasma concentrations declined bi-exponentially with half-life values ranging from 3.1 to 6.7 hours (10 and 30 mg), increasing up to 8.9 to 19.6 hours (doses up to 1000 mg). Exposure values increased dose-proportionally between 100 and 1000 mg for P218 (parent) and three primary metabolites (P218 β-acyl glucuronide, P218-OH and P218-OH β-acyl glucuronide). Co-administration of P218 with food reduced C max by 35% and delayed absorption by 1 hour, with no significant impact on AUC.
CONCLUSION
P218 displayed favourable safety, tolerability and pharmacokinetics. In view of its short half-life, a long-acting formulation will be needed for malaria chemoprotection.",2020,"RESULTS
P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.",['healthy subjects'],"['placebo', 'Co']","['Plasma concentrations', 'safety, tolerability, pharmacokinetics and food effect', 'delayed absorption', 'safety, tolerability and pharmacokinetics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",8.0,0.0945555,"RESULTS
P218 was generally well tolerated across all doses; 21 treatment-emergent adverse events occurred in 15/64 subjects.","[{'ForeName': 'M Farouk', 'Initials': 'MF', 'LastName': 'Chughlay', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rossignol', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Donini', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'El Gaaloul', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lorch', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coates', 'Affiliation': 'Richmond Pharmacology Ltd, London, UK.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Langdon', 'Affiliation': 'PTx Solutions, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hammond', 'Affiliation': 'Preclinical Safety Consulting Ltd, Loughborough, Leicestershire, UK.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14219']
868,32434709,Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials.,"BACKGROUND
Recruitment of participants is crucial to the success of any trial as it can have a major impact on study costs, the duration of the study itself, and, more critically, trial failure. Given that vulvodynia particularly affects young women, the use of social media and e-recruitment could prove efficient for enrollment.
AIM
To compare the efficiency, effectiveness, and cost-effectiveness of three different recruitment methods.
METHODS
The comparison data were collected as part of a bicentric randomized controlled trial evaluating the efficacy of physiotherapy in comparison with topical lidocaine in 212 women suffering from provoked vestibulodynia. The recruitment methods included: (i) conventional methods (eg, posters, leaflets, business cards, newspaper ads); (ii) health professional referrals, and (iii) e-recruitment (eg, Facebook ads and web initiatives). Women interested in participating were screened by telephone for eligibility criteria and were assessed by a gynecologist to confirm their diagnosis. Once included, structured interviews were undertaken to describe their baseline characteristics.
MAIN OUTCOME MEASURES
The outcomes of this study were the recruitment efficiency (the number of patients screened/enrolled), recruitment effectiveness (the number of participants enrolled), cost-effectiveness (cost per enrolled participant), and retention rate, and baseline characteristics of participants were monitored for each method.
RESULTS
The conventional methods (n = 101, 48%) were more effective as they allowed for greater enrollment of participants, followed by e-recruitment (n = 60, 28%) and health professional referrals (n = 33, 16%) (P < 0.007). Recruitment efficiency was found to be similar for e-recruitment and referrals (60/122 and 33/67, 49%, P = 0.055) but lower for conventional methods (101/314, 32%, P < 0.011). Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588). The average cost per enrolled participant was fairly similar for e-recruitment ($117) and conventional methods ($110) and lower for referrals ($60).
CLINICAL IMPLICATIONS
Our results suggest that having a variety of recruitment methods is beneficial in promoting clinical trial recruitment without affecting participant characteristics and retention rates.
STRENGTH & LIMITATIONS
Although recruitment methods were used concomitantly, this study gives an excellent insight into the advantages and limitations of recruitment methods owing to a large sample size.
CONCLUSION
The study findings revealed that e-recruitment is a valuable recruitment method because of its comparable efficiency and cost-effectiveness to health professional referrals and conventional methods, respectively.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, number NCT01455350. Benoit-Piau J, Dumoulin C, Carroll MS, et al. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med 2020;17:1304-1311.",2020,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).",['212 women suffering from provoked vestibulodynia'],"['conventional methods (eg, posters, leaflets, business cards, newspaper ads', 'topical lidocaine']","['cost-effectiveness (cost per enrolled participant), and retention rate', 'Recruitment efficiency', 'health professional referrals', 'Efficiency and Cost', 'retention rate', 'efficiency, effectiveness, and cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",212.0,0.330363,"Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588).","[{'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Benoit-Piau', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal, and Research Center, Institut universitaire de gériatrie de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Marie-Soleil', 'Initials': 'MS', 'LastName': 'Carroll', 'Affiliation': ""Faculty of Medicine and Health Sciences, Université de Sherbrooke, and Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada.""}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal, and Research Center, Centre hospitalier de l'Université de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, Université de Montréal, Montréal, QC, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khalifé', 'Affiliation': 'Jewish General Hospital and Royal Victoria Hospital, McGill University Health Center, Montréal, QC, Canada.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Waddell', 'Affiliation': 'Department of Obstetrics and Gynecology, CHUS and Université de Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Research Center, Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC, Canada. Electronic address: melanie.m.morin@usherbrooke.ca.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.04.005']
869,32107012,Training with cognitive load improves performance under similar conditions in a real surgical task.,"BACKGROUND
Enhancing cognitive load while performing a bimanual surgical task affects performance. Whether repeated training under this condition could benefit performance in an operating room was tested using a virtual reality simulator with cognitive load applied through two-digit math multiplication questions.
METHOD
11 subjects were randomized to Control, VR and VR + CL groups. After a pre-test, VR and VR + CL groups repeated the peg transfer task 150 times over 15 sessions with cognitive load applied only for the last 100 trials. After training, all groups took a post-test and two weeks later the retention test with and without cognitive load and the transfer task on a pig intestine of 150 cm long under cognitive load.
RESULTS AND CONCLUSION
Mixed ANOVA analysis showed significant differences between the control and VR and VR + CL groups (p = 0.013, p = 0.009) but no differences between the VR + CL and the VR groups (p = 1.0). GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03). Training under cognitive load benefitted performance on an actual surgical task under similar conditions.",2020,"GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03).",['11 subjects'],"['Control, VR and VR\xa0+\xa0CL', 'retention test with and without cognitive load and the transfer task on a pig intestine of 150\xa0cm long under cognitive load', 'VR\xa0+\xa0CL']",[],[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0039005', 'cui_str': 'Pigs'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",[],11.0,0.0101945,"GOALS bimanual dexterity score on transfer test show that VR + CL group outperformed both Control and VR groups (p = 0.016, p = 0.03).","[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA. Electronic address: ganesh.sankaranarayanan@bswhealth.org.'}, {'ForeName': 'Coleman A', 'Initials': 'CA', 'LastName': 'Odlozil', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Katerina O', 'Initials': 'KO', 'LastName': 'Wells', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Leeds', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Sanket', 'Initials': 'S', 'LastName': 'Chauhan', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Fleshman', 'Affiliation': 'Department of Surgery, Baylor University Medical Center at Dallas, Dallas, TX, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Jones', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Suvranu', 'Initials': 'S', 'LastName': 'De', 'Affiliation': 'Center for Modeling, Simulation, and Imaging in Medicine, Rensselaer Polytechnic Institute, Troy, NY, USA.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.02.002']
870,32063029,Adding new experimental arms to randomised clinical trials: Impact on error rates.,"BACKGROUND
Experimental treatments pass through various stages of development. If a treatment passes through early-phase experiments, the investigators may want to assess it in a late-phase randomised controlled trial. An efficient way to do this is adding it as a new research arm to an ongoing trial while the existing research arms continue, a so-called multi-arm platform trial. The familywise type I error rate is often a key quantity of interest in any multi-arm platform trial. We set out to clarify how it should be calculated when new arms are added to a trial some time after it has started.
METHODS
We show how the familywise type I error rate, any-pair and all-pairs powers can be calculated when a new arm is added to a platform trial. We extend the Dunnett probability and derive analytical formulae for the correlation between the test statistics of the existing pairwise comparison and that of the newly added arm. We also verify our analytical derivation via simulations.
RESULTS
Our results indicate that the familywise type I error rate depends on the shared control arm information (i.e. individuals in continuous and binary outcomes and primary outcome events in time-to-event outcomes) from the common control arm patients and the allocation ratio. The familywise type I error rate is driven more by the number of pairwise comparisons and the corresponding (pairwise) type I error rates than by the timing of the addition of the new arms. The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30.
CONCLUSIONS
The findings we present in this article can be used to design trials with pre-planned deferred arms or to add new pairwise comparisons within an ongoing platform trial where control of the pairwise error rate or familywise type I error rate (for a subset of pairwise comparisons) is required.",2020,"The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30.
",[],[],[],[],[],[],,0.202982,"The familywise type I error rate can be estimated using Šidák's correction if the correlation between the test statistics of pairwise comparisons is less than 0.30.
","[{'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Choodari-Oskooei', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bratton', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Gannon', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Meade', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mahesh Kb', 'Initials': 'MK', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774520904346']
871,32434744,Risk for Delayed Graft Function in Deceased Donor Renal Transplant Patients: A Single-Center Experience From North India.,"OBJECTIVES
Delayed graft function (DGF) in renal allograft transplantation refers to the need for dialysis in the first week after renal transplantation. This study analyzed the causes of DGF in deceased donor transplantation.
METHODS
Data from January 2018 to July 2019 was reviewed with regard to donor and recipient characteristics such as demographics, biochemical parameters, organ dysfunction, and preterminal management. The recipients were divided into 2 groups: group I: patients without DGF and group II: patients with DGF.
RESULTS
Kidneys were retrieved from 49 deceased donors (male:female = 41:8) and transplanted to 95 recipients (male:female = 60:35). Mean age of the donors and recipients was 35.34 ± 18.2 and 40.72 ± 13.30 years, respectively. The most common cause of brain death was central nervous system trauma (45 out of 49, 91%). In total, 20/95 (21%) recipients had DGF. Twelve recipients had received kidneys from donors who had circulatory arrest. Two patients were re-explored on postoperative day 1 for bleeding from renal artery anastomosis. The mean age in group I and group II was 28.65 ± 10.2 and 37.38 ± 12.28 years, respectively. The mean cold ischemia time in group I and group II was 398.73 ± 187.19 and 333.24 ± 115.49 minutes, respectively. The mean hospital stay of donor before donation in group I and group II was 4.34 ± 1.27 and 6 ± 2.95 days, respectively. The terminal donor creatinine in group I and group II was 0.88 ± 0.47 and 2.33 ± 1.73 mg/dL, respectively.
CONCLUSION
DGF in deceased donor transplantation may be attributed to donation after circulatory death, prolonged donor hospital stay, high donor leukocyte count, and high terminal creatinine.",2020,"The mean hospital stay of donor before donation in group I and group II was 4.34 ± 1.27 and 6 ± 2.95 days, respectively.","['Mean age of the donors and recipients was 35.34 ± 18.2 and 40.72 ± 13.30 years, respectively', 'Deceased Donor Renal Transplant Patients', 'Data from January 2018 to July 2019 was reviewed with regard to donor and recipient characteristics such as demographics, biochemical parameters, organ dysfunction, and preterminal management', 'deceased donor transplantation', 'Twelve recipients had received kidneys from donors who had circulatory arrest', 'Kidneys were retrieved from 49 deceased donors (male:female\xa0= 41:8) and transplanted to 95 recipients (male:female\xa0= 60:35', 'and group II: patients with DGF']","['Delayed graft function (DGF', 'DGF']","['mean hospital stay of donor before donation', 'mean cold ischemia time']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0730392', 'cui_str': 'Donor renal transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0444720', 'cui_str': 'Circulatory arrest'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}]","[{'cui': 'C1566590', 'cui_str': 'Delayed graft function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C4049936', 'cui_str': 'Patient status determination, deceased and body donated'}, {'cui': 'C1563922', 'cui_str': 'Cold Ischemic Time'}]",2.0,0.0250709,"The mean hospital stay of donor before donation in group I and group II was 4.34 ± 1.27 and 6 ± 2.95 days, respectively.","[{'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Deepesh Benjamin', 'Initials': 'DB', 'LastName': 'Kenwar', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Shivakumar S', 'Initials': 'SS', 'LastName': 'Patil', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Gaurav Shankar', 'Initials': 'GS', 'LastName': 'Pandey', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vidyasagar', 'Initials': 'V', 'LastName': 'Kallepalli', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sahil', 'Initials': 'S', 'LastName': 'Rally', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Thakur', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Milind', 'Initials': 'M', 'LastName': 'Mandwar', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sarbpreet', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Renal Transplant Surgery, Nehru Building, Post Graduate Institute of Medical Education and Research, Chandigarh, India. Electronic address: drsarbpreet@yahoo.com.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.04.003']
872,31366999,The effectiveness of home versus community-based weight control programmes initiated soon after breast cancer diagnosis: a randomised controlled trial.,"BACKGROUND
Breast cancer diagnosis may be a teachable moment for lifestyle behaviour change and to prevent adjuvant therapy associated weight gain. We assessed the acceptability and effectiveness of two weight control programmes initiated soon after breast cancer diagnosis to reduce weight amongst overweight or obese women and prevent gains in normal-weight women.
METHODS
Overweight or obese (n = 243) and normal weight (n = 166) women were randomised to a three-month unsupervised home (home), a supervised community weight control programme (community) or to standard written advice (control). Primary end points were change in weight and body fat at 12 months. Secondary end points included change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes.
RESULTS
Forty-three percent of eligible women were recruited. Both programmes reduced weight and body fat: home vs. control mean (95% CI); weight -2.3 (-3.5, -1.0) kg, body fat -1.6 (-2.6, -0.7) kg, community vs. control; weight -2.4 (-3.6, -1.1) kg, body fat -1.4 (-2.4, -0.5) kg (all p < 0.001). The community group increased physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective.
CONCLUSIONS
The programmes were equally effective for weight control, but the community programme had additional benefits.
CLINICAL TRIAL REGISTRATION
ISRCTN68576140.",2019,Both programmes reduced weight and body fat: home vs. control,"['overweight or obese women and prevent gains in normal-weight women', 'Forty-three percent of eligible women were recruited', 'Overweight or obese (n\u2009=\u2009243) and normal weight (n\u2009', '166) women', 'breast cancer diagnosis']","['home versus community-based weight control programmes', 'supervised community weight control programme (community) or to standard written advice (control']","['change in weight and body fat', 'acceptability and effectiveness', 'change in insulin, cardiovascular risk markers, quality of life and cost-effectiveness of the programmes', 'physical activity, reduced insulin, cardiovascular disease risk markers, increased QOL and was cost-effective', 'weight and body fat']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}]",,0.108066,Both programmes reduced weight and body fat: home vs. control,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Harvie', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK. michelle.harvie@manchester.ac.uk.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Pegington', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'McMullan', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bundred', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Livingstone', 'Affiliation': 'The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'School of Applied Sciences, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wolstenholme', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanora', 'Initials': 'E', 'LastName': 'Lovato', 'Affiliation': 'Nuffield Department of Population Health, Health Economics Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Clinical Radiology, Faculty of Medicine Biology and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Speed', 'Affiliation': 'The School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Howell', 'Affiliation': 'Manchester Breast Centre, Manchester Cancer Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Prevent Breast Cancer Research Unit, The Nightingale Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}]",British journal of cancer,['10.1038/s41416-019-0522-6']
873,31479032,The effects of testosterone administration on muscle areas of the trunk and pelvic floor in hysterectomized women with low testosterone levels: proof-of-concept study.,"OBJECTIVE
The aim of this study was to determine the effect of testosterone administration on trunk and pelvic floor muscle area in women with low testosterone levels.
METHODS
Participants were hysterectomized women with total testosterone<31 ng/dL and/or free testosterone<3.5 pg/mL; participating in the Testosterone Dose Response in Surgically Menopausal Women (TDSM) trial. All participants received a standardized transdermal estradiol regimen during the 12-week run-in period, and were then randomized to receive weekly intramuscular injections of placebo, or 3, 6.25, 12.5, or 25 mg testosterone enanthate for 24 weeks. Muscle areas of the trunk and pelvis were measured at baseline and end of treatment using 1.5 Tesla magnetic resonance imaging. Total and free testosterone levels were measured by liquid chromatography-tandem mass spectrometry and equilibrium dialysis, respectively. Testosterone effect on muscle areas was analyzed using linear regression models.
RESULTS
A total of 24 women who had available baseline and posttreatment magnetic resonance imaging were included in the analysis. Increased cross-sectional areas of the paraspinal, psoas, and abdominal wall muscles were seen after testosterone administration. The estimated mean change (95% CI; P value) between treatment groups was 4.07 cm (1.26-6.88; P = 0.007) for paraspinal, 1.60 cm (0.10-3.09; P = 0.038) for psoas major, and 7.49 cm (1.96-13.02; P = 0.011) for abdominal wall muscles. Increases in psoas muscle area were significantly associated with changes in free testosterone concentrations. No significant changes in obturator internus and pelvic floor muscle areas were observed.
CONCLUSION
Short-term testosterone administration in women with low testosterone levels was associated with increased trunk muscle area.",2019,"Increased cross-sectional areas of the paraspinal, psoas, and abdominal wall muscles were seen after testosterone administration.","['Participants were hysterectomized women with total testosterone<31 ng/dL', 'women with low testosterone levels', 'Surgically Menopausal Women (TDSM) trial', 'hysterectomized women with low testosterone levels', '24 women who had available baseline and posttreatment magnetic resonance imaging were included in the analysis']","['standardized transdermal estradiol regimen', 'placebo', 'testosterone enanthate', 'Testosterone', 'testosterone']","['Total and free testosterone levels', 'obturator internus and pelvic floor muscle areas', 'free testosterone concentrations', 'psoas muscle area']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439274', 'cui_str': 'ng/dL'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0076189', 'cui_str': 'testosterone enanthate'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0224422', 'cui_str': 'Internal obturator muscle structure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0085221', 'cui_str': 'Psoas Muscles'}]",,0.371009,"Increased cross-sectional areas of the paraspinal, psoas, and abdominal wall muscles were seen after testosterone administration.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tapper', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine, Centre for Andrology and Sexual Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Martling', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Blomqvist', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Buchli', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Program on Ageing, Hebrew Senior Life, Roslindale, MA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Storer', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health, Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001410']
874,31785594,Neonatal encephalopathy therapy optimization for better neuroprotection with inhalation of CO 2 : the HENRIC feasibility and safety trial.,"BACKGROUND
There is an association between hypocapnia and adverse neurodevelopmental outcome in infants with neonatal encephalopathy (NE). Our aim was to test the safety and feasibility of 5% CO 2 and 95% air inhalation to correct hypocapnia in mechanically ventilated infants with NE undergoing therapeutic hypothermia.
METHODS
Ten infants were assigned to this open-label, single-center trial. The gas mixture of 5% CO 2 and 95% air was administered through patient circuits if the temperature-corrected PCO 2 ≤40 mm Hg. The CO 2 inhalation was continued for 12 h or was stopped earlier if the base deficit (BD) level decreased <5 mmol/L. Follow-up was performed using Bayley Scales of Infant Development II.
RESULTS
The patients spent a median 95.1% (range 44.6-98.5%) of time in the desired PCO 2 range (40-60 mm Hg) during the inhalation. All PCO 2 values were >40 mm Hg, the lower value of the target range. Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable. The rate of moderate disabilities and normal outcome was 50%.
CONCLUSIONS
Our results suggest that inhaled 5% CO 2 administration is a feasible and safe intervention for correcting hypocapnia.",2020,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","['mechanically ventilated infants with NE undergoing therapeutic hypothermia', 'infants with neonatal encephalopathy (NE']",[],"['rate of moderate disabilities and normal outcome', 'safety and feasibility']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy (disorder)'}]",[],"[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.143105,"Regression modeling revealed that BD and lactate had a tendency to decrease during the intervention (by 0.61 and 0.55 mmol/L/h, respectively), whereas pH remained stable.","[{'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Szakmar', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Kovacs', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Unoke', 'Initials': 'U', 'LastName': 'Meder', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Geza', 'Initials': 'G', 'LastName': 'Bokodi', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Csilla', 'Initials': 'C', 'LastName': 'Andorka', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lakatos', 'Affiliation': 'MR Research Centre, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Attila J', 'Initials': 'AJ', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Gusztav', 'Initials': 'G', 'LastName': 'Belteki', 'Affiliation': 'Neonatal Intensive Care Unit, Cambridge University Hospitals NHS Trust, Cambridge, UK.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Szabo', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jermendy', 'Affiliation': '1st Department of Paediatrics, Semmelweis University, Budapest, Hungary. jermendy.agnes@med.semmelweis-univ.hu.'}]",Pediatric research,['10.1038/s41390-019-0697-9']
875,32433377,Incorporating a Microlearning Wellness Intervention Into Nursing Student Curricula.,"BACKGROUND
Cultivating healthy lifestyle beliefs (HLBs) can result in positive health outcomes for students during their nursing program.
PURPOSE
The purpose of the study was to determine the effectiveness of short wellness interventions (microlearning) in nursing courses on reducing stress and anxiety and enhancing HLB.
METHODS
Microlearning wellness interventions were offered to graduate and undergraduate nursing students in this cluster randomized intervention study. The Perceived Stress Scale 4, Generalized Anxiety Disorder 7, and Healthy Lifestyle Beliefs Scales were administered. Student perceptions were evaluated using a short answer narrative.
RESULTS
The intervention group reported higher HLB (P = .15), lower anxiety (P = .06), and lower stress (P = .06) compared with the control group after adjusting for baseline differences. Student comments were favorable and included enjoying the activities, weight loss success, and mindfulness strategies.
CONCLUSIONS
Incorporating wellness interventions into nursing curricula demonstrates a positive trend toward reducing anxiety and stress and improving HLB.",2021,"The intervention group reported higher HLB (P = .15), lower anxiety (P = .06), and lower stress (P = .06) compared with the control group after adjusting for baseline differences.","['Microlearning wellness interventions were offered to graduate and undergraduate nursing students', 'students during their nursing program']",['short wellness interventions (microlearning'],"['lower stress', 'higher HLB', 'stress and anxiety and enhancing HLB', 'Perceived Stress Scale 4, Generalized Anxiety Disorder 7, and Healthy Lifestyle Beliefs Scales', 'anxiety and stress and improving HLB', 'lower anxiety', 'enjoying the activities, weight loss success, and mindfulness strategies']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0193499,"The intervention group reported higher HLB (P = .15), lower anxiety (P = .06), and lower stress (P = .06) compared with the control group after adjusting for baseline differences.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Gawlik', 'Affiliation': 'Author Affiliations: Assistant Professor of Clinical Nursing (Dr Gawlik), Biostatistician 1 (Dr Guo), Research Associate Professor (Dr Tan), and Professor of Clinical Nursing (Dr Overcash), The Ohio State University, College of Nursing, Columbus.'}, {'ForeName': 'Jinghong', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ''}, {'ForeName': 'Alai', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Overcash', 'Affiliation': ''}]",Nurse educator,['10.1097/NNE.0000000000000842']
876,32071919,Autologous Micrografts from Scalp Tissue: Trichoscopic and Long-Term Clinical Evaluation in Male and Female Androgenetic Alopecia.,"Tissue engineering in hair regrowth aims to develop innovative and not-invasive procedures to advance the hair regrowth. A placebo-controlled, randomized, evaluator-blinded, half-head group study to compare hair regrowth with micrografts containing human hair follicle mesenchymal stem cells (HF-MSCs) vs. placebo was reported. After 58 weeks, 27 patients displayed in the targeted area an increase of hair count and hair density, respectively, of 18.0 hairs per 0.65 cm 2 and 23.3 hairs per cm 2 compared with baseline, while the control area displayed a mean decrease of 1.1 hairs per 0.65 cm 2 and 0.7 hairs per cm 2 (control vs. treatment: P < 0.0001). After 26 months, 6 patients revealed dynamic hair loss and were retreated. More broad controlled examinations are required. HF-MSCs contained in micrografts may represent a safe and viable treatment alternative against hair loss.",2020,Tissue engineering in hair regrowth aims to develop innovative and not-invasive procedures to advance the hair regrowth.,"['Autologous Micrografts from Scalp Tissue', 'Male and Female Androgenetic Alopecia']","['placebo', 'hair regrowth with micrografts containing human hair follicle mesenchymal stem cells (HF-MSCs) vs. placebo', 'Trichoscopic']","['hair count and hair density', 'dynamic hair loss']","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0162311', 'cui_str': 'Pattern Baldness'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0221971', 'cui_str': 'Hair Follicle'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}]","[{'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]",,0.184726,Tissue engineering in hair regrowth aims to develop innovative and not-invasive procedures to advance the hair regrowth.,"[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Gentile', 'Affiliation': 'Surgical Science Department, Plastic and Reconstructive Surgery, Tor Vergata University, Rome 00173, Italy.'}, {'ForeName': 'Maria Giovanna', 'Initials': 'MG', 'LastName': 'Scioli', 'Affiliation': 'Biomedicines and Prevention Department, Anatomy Pathologic, Tor Vergata University, Rome 00173, Italy.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Cervelli', 'Affiliation': 'Surgical Science Department, Plastic and Reconstructive Surgery, Tor Vergata University, Rome 00173, Italy.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Orlandi', 'Affiliation': 'Biomedicines and Prevention Department, Anatomy Pathologic, Tor Vergata University, Rome 00173, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Garcovich', 'Affiliation': 'Institute of Dermatology, F. Policlinico Gemelli IRCSS, Università Cattolica Del Sacro Cuore, 00168 Rome, Italy.'}]",BioMed research international,['10.1155/2020/7397162']
877,32071923,Effects of 12-Week Exercise Program on Enzyme Activity of Serum Matrix Metalloproteinase-9 and Tissue Inhibitor of Metalloproteinase-1 in Female Patients with Postmenopausal Osteoporosis: A Randomized Control Study.,"Background
Osteoporosis is a disease characterized by decreased bone density and destruction of bone microarchitecture. Indicators for altered bone homeostasis are changes in the serum level of matrix metalloproteinases (MMPs) and their tissue inhibitors (TIMPs). The purpose of the current study was to evaluate the effect of a 12-week exercise program on enzyme activity of serum MMP-9 and TIMP-1 in postmenopausal osteoporotic patients. Materials and methods . Participants were randomized in two groups: exercise (EG) ( N = 37) and control (CG) ( N = 37) and control (CG) (.
Results
Significant differences between pretreatment and posttreatment enzyme activities of serum MMP-9 ( p =0.009), TIMP-1 ( p =0.009), TIMP-1 ( p =0.009), TIMP-1 (.
Conclusion
Our results suggest that a 12-week exercise program has an influence on enzyme activity of serum MMP-9, revealing a possible role of MMPs in initiating training-specific adaptation. Although measurements of circulating MMP-9 and TIMP-1 allowed us to detect effects of exercise, as of today, they have no real role in the diagnosis of osteoporosis and/or follow-up of osteoporotic patient's response to treatment. MMP-9 might be used as an important prognostic marker for the evaluation of patient's response to exercise. Larger-randomized controlled studies need to be performed to expand this area of knowledge. This trial is registered with trial registration number: NCT03816449).",2020,"Results
Significant differences between pretreatment and posttreatment enzyme activities of serum MMP-9 ( p =0.009), TIMP-1 ( p =0.009), TIMP-1 ( p =0.009), TIMP-1","['Female Patients with Postmenopausal Osteoporosis', 'postmenopausal osteoporotic patients']","['exercise (EG) ( N \u2009=\u200937) and control (CG', '12-Week Exercise Program', 'exercise program']","['TIMP-1', 'enzyme activity of serum MMP-9 and TIMP-1', 'posttreatment enzyme activities of serum MMP-9', 'Enzyme Activity of Serum Matrix Metalloproteinase-9 and Tissue Inhibitor of Metalloproteinase-1', 'bone density and destruction of bone microarchitecture']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal Bone Loss'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0145947', 'cui_str': 'TIMP-1'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure (procedure)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}]",,0.0172778,"Results
Significant differences between pretreatment and posttreatment enzyme activities of serum MMP-9 ( p =0.009), TIMP-1 ( p =0.009), TIMP-1 ( p =0.009), TIMP-1","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Filipović', 'Affiliation': 'Institute for Rehabilitation, School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gopčević', 'Affiliation': 'Institute for Chemistry in Medicine, School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Dimitrijević', 'Affiliation': 'Special Hospital for Cerebral Palsy and Developmental Neurology, School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Marija', 'Initials': 'M', 'LastName': 'Hrković', 'Affiliation': 'Institute for Rehabilitation, School of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Backović', 'Affiliation': 'Turval Laboratory Srl, Udine, Italy.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Lazović', 'Affiliation': 'Institute for Rehabilitation, School of Medicine, University of Belgrade, Belgrade, Serbia.'}]",BioMed research international,['10.1155/2020/9758289']
878,32073199,The Effect of Rapid Fluid Infusions on Transabdominal Pelvic Ultrasound Timing Among Female Pediatric Patients: A Randomized Controlled Pilot Trial.,,2020,"Unlike transvaginal ultrasounds, the patient's bladder must be full to receive a high-quality sonographic view.","['female pediatric patients', 'females who are not sexually active']","['rapid fluid infusions', 'transurethral catheterization', 'Transabdominal ultrasound', 'Oral or intravenous (IV) fluids and bladder filling']",[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}]",[],,0.21182,"Unlike transvaginal ultrasounds, the patient's bladder must be full to receive a high-quality sonographic view.","[{'ForeName': 'Todd P', 'Initials': 'TP', 'LastName': 'Chang', 'Affiliation': ""From the, Division of Emergency Medicine & Transport, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Sofronia M', 'Initials': 'SM', 'LastName': 'Ringold', 'Affiliation': ""From the, Division of Emergency Medicine & Transport, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Nhan', 'Initials': 'N', 'LastName': 'Lichtenfeld', 'Affiliation': ""From the, Division of Emergency Medicine & Transport, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Phaedra', 'Initials': 'P', 'LastName': 'Nguyen', 'Affiliation': ""From the, Division of Emergency Medicine & Transport, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Delta', 'Initials': 'D', 'LastName': 'Paz', 'Affiliation': ""From the, Division of Emergency Medicine & Transport, Children's Hospital Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Festekjian', 'Affiliation': ""From the, Division of Emergency Medicine & Transport, Children's Hospital Los Angeles, Los Angeles, CA.""}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13945']
879,32434001,Platelet activation and placenta-mediated adverse pregnancy outcomes: an ancillary study to the Effects of Aspirin in Gestation and Reproduction trial.,"BACKGROUND
Platelet activation may play a role in the pathophysiology of placenta-mediated obstetrical complications, as evidenced by the efficacy of aspirin in preventing preeclampsia, but published data regarding the relationship between biomarkers for platelet activation and adverse obstetrical outcomes are sparse. In particular, it is unknown whether prepregnancy biomarkers of platelet activation are associated with adverse pregnancy outcomes.
OBJECTIVE
This study aimed to determine the following: (1) whether maternal plasma concentrations of platelet factor 4 are associated with risk of placenta-mediated adverse obstetrical outcomes, and (2) whether these associations are modified by low-dose aspirin.
STUDY DESIGN
This ancillary study included measurement of platelet factor 4 among 1185 of 1228 women of reproductive age enrolled in the Effects of Aspirin in Gestation and Reproduction trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation. We measured platelet factor 4 in plasma samples obtained at the prepregnancy study visit (before randomization to low-dose aspirin or placebo), 12 weeks' gestation, and 28 weeks' gestation. The primary outcome was a composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational-age infant. We estimated the relative risks (RRs) and 95% confidence intervals (CIs) for the association between platelet factor 4 and the composite and individual outcomes at each time point using log-binomial regression that was weighted to account for potential selection bias and adjusted for age, body mass index, education, income, and smoking. To evaluate the potential effect modification of aspirin, we stratified the analyses by aspirin treatment assignment.
RESULTS
During follow-up, 95 women experienced the composite adverse obstetrical outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small for gestational age, and 6 of placental abruption. Overall, prepregnancy platelet factor 4 was positively associated with the composite outcome (third tertile vs first tertile; relative risk, 2.36; 95% confidence interval, 1.38-4.03) and with hypertensive disorders of pregnancy (third tertile vs first tertile; relative risk, 2.14; 95% confidence interval, 1.08-4.23). In analyses stratified by treatment group, associations were stronger in the placebo group (third tertile vs first tertile; relative risk, 3.36; 95% confidence interval, 1.42-7.93) than in the aspirin group (third tertile vs first tertile; relative risk, 1.78; 95% confidence interval, 0.90-3.50).
CONCLUSION
High concentrations of platelet factor 4 before pregnancy are associated with increased risk of placenta-mediated adverse pregnancy outcomes, particularly for hypertensive disorders of pregnancy. Aspirin may mitigate the increased risk of these outcomes among women with higher plasma concentrations of preconception platelet factor 4, but low-dose aspirin nonresponders may require higher doses of aspirin or alternate therapies to achieve obstetrical risk reduction.",2020,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[""1,185 of the 1,228 reproductive-age women enrolled in the Effects of Aspirin in Gestation and Reproduction (EAGeR) trial with available plasma samples, with relevant outcomes assessed among 584 women with pregnancies lasting at least 20 weeks' gestation"", '95 women experienced the composite adverse obstetric outcome, with 57 cases of hypertensive disorders of pregnancy, 35 of small-for-gestational age (SGA), and 6 of placental abruption']","['Aspirin', 'aspirin', 'aspirin or placebo']","['composite of hypertensive disorders of pregnancy, placental abruption, and small-for-gestational age neonate', 'hypertensive disorders of pregnancy', 'Platelet activation and placenta-mediated adverse pregnancy outcomes']","[{'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",584.0,0.178718,"In analyses stratified by treatment group, associations were stronger in the placebo (tertile 3 vs. tertile 1 RR 3.36, 95% CI 1.42, 7.93) versus the aspirin group (tertile 3 vs. tertile 1 RR 1.78, 95% CI 0.90, 3.50).
","[{'ForeName': 'Lauren H', 'Initials': 'LH', 'LastName': 'Theilen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT. Electronic address: lauren.theilen@hsc.utah.edu.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Campbell', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Purdue-Smithe', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Jeannie G', 'Initials': 'JG', 'LastName': 'Radoc', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah Health, Salt Lake City, UT; Women and Newborns Clinical Program, Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Division of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.026']
880,32433378,A Combination of Self-debriefing and Instructor-led Debriefing Improves Team Effectiveness in Health Science Students.,"BACKGROUND
Debriefing is considered a critical component of simulation-based learning, but the differences between different debriefing methods remain unclear.
PURPOSE
The purpose of the study was to investigate the effectiveness of the debriefing assessment, problem-solving process, and team effectiveness among students who received instructor-led debriefing, self-debriefing, and combined debriefing.
METHODS
An experimental design was conducted with 250 students (nursing, physiotherapy, and occupational therapy). Differences in the Debriefing Experience Scale (DES), Problem Solving Inventory (PSI), and Communication and Teamwork Skills (CATS) assessment between the groups were measured.
RESULTS
In nursing students, the combined debriefing group had the highest scores for the CATS assessment (P < .001) and for the coordination (P < .001), cooperation (P = .012), and communication (P = .002) categories. No significant differences were observed between debriefing groups for DES or PSI.
CONCLUSIONS
Combined debriefing improves communication and team skills in students. Educators might promote combined debriefing after simulation sessions as it seems to improve team effectiveness.",2021,"In nursing students, the combined debriefing group had the highest scores for the CATS assessment (P < .001) and for the coordination (P < .001), cooperation (P = .012), and communication (P = .002) categories.","['students', 'Health Science Students', 'students who received', '250 students (nursing, physiotherapy, and occupational therapy']","['Self-debriefing and Instructor-Led Debriefing', 'instructor-led debriefing, self-debriefing, and combined debriefing']","['communication and team skills', 'Debriefing Experience Scale (DES), Problem Solving Inventory (PSI), and Communication and Teamwork Skills (CATS) assessment']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",250.0,0.0302018,"In nursing students, the combined debriefing group had the highest scores for the CATS assessment (P < .001) and for the coordination (P < .001), cooperation (P = .012), and communication (P = .002) categories.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Rueda-Medina', 'Affiliation': 'Author Affiliations: Professor, (Dr Rueda-Medina), Associate Professors, (Drs Gómez-Urquiza, Molina-Rivas, and Correa-Rodríguez), Nursing Department at the University of Granada; Associate Professors, (Tapia-Haro, and Aguilar-Ferrándiz), Physical Therapy Department at the University of Granada, Spain.'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Gómez-Urquiza', 'Affiliation': ''}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Molina-Rivas', 'Affiliation': ''}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Tapia-Haro', 'Affiliation': ''}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': ''}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Correa-Rodríguez', 'Affiliation': ''}]",Nurse educator,['10.1097/NNE.0000000000000845']
881,31499457,Age differences in electrocortical reactivity to fearful faces following aversive conditioning in youth.,"Although biases in the processing of affectively salient stimuli are thought to increase risk for psychopathology across the lifespan, questions remain regarding how these biases develop. The current study tested an aversive conditioning model for the development of children's sensitivity in detecting fearful faces at varying levels of emotional intensity and their facilitated attention to fearful faces assessed via the late positive potential (LPP) event-related potential component. Participants (N = 144, ages 7-11 years) were randomly assigned to one of three conditions: an active training condition in which an 85-dB white noise burst was paired with fearful faces, an active control condition in which the white noise was presented randomly throughout the task, and a no-sound condition. Children completed a separate task in which they viewed happy, sad, and fearful child faces at varying levels of emotional intensity while electroencephalography (EEG) was recorded. Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age. Among younger children, those in the active conditioning group exhibited smaller LPP amplitudes to high-intensity fearful faces than children in the control groups. However, among older youth, those in the active conditioning group exhibited larger LPP amplitudes to high-intensity fearful faces than children in the control groups. These findings provide insight into how attentional biases may develop in children and how period of development may influence these patterns.",2019,"Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age.","['youth', 'younger children', 'Participants (N\u202f=\u202f144, ages 7-11\u202fyears']","['active training condition in which an 85-dB white noise burst was paired with fearful faces, an active control condition in which the white noise was presented randomly throughout the task, and a no-sound condition']","['smaller LPP amplitudes', 'LPP amplitudes', 'LPP magnitude']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",,0.0533471,"Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Burkhouse', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60608, USA. Electronic address: kburkho@uic.edu.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL 33701, USA.'}, {'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Department of Psychology, Binghamton University (State University of New York), Binghamton, NY 13902, USA.'}, {'ForeName': 'Brandon E', 'Initials': 'BE', 'LastName': 'Gibb', 'Affiliation': 'Department of Psychology, Binghamton University (State University of New York), Binghamton, NY 13902, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104676']
882,31954014,Comparison of dual task specific training and conventional physical therapy in ambulation of hemiplegic stroke patients: A randomized controlled trial.,"OBJECTIVE
To compare the effectiveness of dual task specific training and conventional physical therapy in ambulation of patients with chronic stroke.
METHODS
The randomised controlled trial was conducted at the Habib Physiotherapy Complex, Peshawar, Pakistan, from January to August 2017, and comprised patients with chronic stroke. The patients were randomly assigned to two treatment groups. Group A received dual task training, while Group B received conventional physiotherapy. Dual task training included activities such as slowlywalking backward, sideways, and forward on a smooth surface while holding a 100gm sandbag. The conventional physiotherapy included mat activities, stretching and strengthening exercises and gait training. Pre-test and post-test data was taken for both spatial and temporal variables for both groups using Time Up and Go Test and 10-meter walk test. Step length, stride length, cycle time and cadence were also calculated before and after treatment. SPSS 23 was used to analyse the data.
RESULTS
Of the 64 patients, there were 32(50%) in each of the two groups that both had 17(53%) males and 15(47%) females. Mean age in Group A was 58.28 ± 7.13 years, while in Group B it was 58.87 ± 6.13 years. Baseline parameters had no significant differences between the groups (p>0.05). Post-treatments scores revealed significant improvement of spatial and temporal variable of gait, 10-meter walk, cadence, step length, stride and cycle time in Group A compared to Group B (p<0.05 each).
CONCLUSIONS
Conventional physical therapy and dual task training effectively improved gait ability of chronic stroke patients, and the latter showed significant improvement in all spatial and temporal gait variables compared to former.",2020,"Post-treatments scores revealed significant improvement of spatial and temporal variable of gait, 10-meter walk, cadence, step length, stride and cycle time in Group A compared to Group B (p<0.05 each).
","['64 patients', 'Habib Physiotherapy Complex, Peshawar, Pakistan, from January to August 2017, and comprised patients with chronic stroke', 'patients with chronic stroke', 'hemiplegic stroke patients', 'chronic stroke patients']","['dual task specific training and conventional physical therapy', 'Conventional physical therapy and dual task training', 'dual task training, while Group B received conventional physiotherapy', 'conventional physiotherapy included mat activities, stretching and strengthening exercises and gait training']","['spatial and temporal variable of gait, 10-meter walk, cadence, step length, stride and cycle time', 'Step length, stride length, cycle time and cadence', 'gait ability', 'spatial and temporal gait variables']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0066317', 'cui_str': 'trisulfide methyl 2-propenyl'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0235484,"Post-treatments scores revealed significant improvement of spatial and temporal variable of gait, 10-meter walk, cadence, step length, stride and cycle time in Group A compared to Group B (p<0.05 each).
","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Iqbal', 'Affiliation': 'Department of Physiotherapy, Paraplegic Center, Peshawar, Pakistan.'}, {'ForeName': 'Aatik', 'Initials': 'A', 'LastName': 'Arsh', 'Affiliation': 'Department of Physiotherapy, Paraplegic Centre Peshawar, Pakistan.'}, {'ForeName': 'Syed Muhammad', 'Initials': 'SM', 'LastName': 'Hammad', 'Affiliation': 'Northwest Institute of Health Sciences, Peshawar, Pakistan.'}, {'ForeName': 'Ijaz Ul', 'Initials': 'IU', 'LastName': 'Haq', 'Affiliation': 'Department of Physiotherapy, Paraplegic Center, Peshawar, Pakistan.'}, {'ForeName': 'Haider', 'Initials': 'H', 'LastName': 'Darain', 'Affiliation': 'Institute of Physical Medicine and Rehabilitation, Khyber Medical University, Peshawar.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.10443']
883,31490816,Arterial Catheters for Early Detection and Treatment of Hypotension During Major Noncardiac Surgery: A Randomized Trial.,"BACKGROUND
Continuous blood pressure monitoring may facilitate early detection and prompt treatment of hypotension. We tested the hypothesis that area under the curve (AUC) mean arterial pressure (MAP) <65 mm Hg is reduced by continuous invasive arterial pressure monitoring.
METHODS
Adults having noncardiac surgery were randomly assigned to continuous invasive arterial pressure or intermittent oscillometric blood pressure monitoring. Arterial catheter pressures were recorded at 1-minute intervals; oscillometric pressures were typically recorded at 5-minute intervals. We estimated the arterial catheter effect on AUC-MAP <65 mm Hg using a multivariable proportional odds model adjusting for imbalanced baseline variables and duration of surgery. Pressures <65 mm Hg were categorized as 0, 1-17, 18-91, and >91 mm Hg × minutes of AUC-MAP <65 mm Hg (ie, no hypotension and 3 equally sized groups of increasing hypotension).
RESULTS
One hundred fifty-two patients were randomly assigned to arterial catheter use and 154 to oscillometric monitoring. For various clinical reasons, 143 patients received an arterial catheter, while 163 were monitored oscillometrically. There were a median [Q1, Q3] of 246 [187, 308] pressure measurements in patients with arterial catheters versus 55 (46, 75) measurements in patients monitored oscillometrically. In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006). The result was robust over an as-treated analysis and for sensitivity analyses with thresholds of 60 and 70 mm Hg.
CONCLUSIONS
Intraoperative blood pressure monitoring with arterial catheters detected nearly twice as much hypotension as oscillometric measurements.",2019,"In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006).","['Hypotension During Major Noncardiac Surgery', '143 patients received an arterial catheter, while 163 were monitored oscillometrically', 'Adults having noncardiac surgery', 'One hundred fifty-two patients']","['AUC-MAP', 'arterial catheter use and 154 to oscillometric monitoring', 'continuous invasive arterial pressure or intermittent oscillometric blood pressure monitoring']","['hypotension', 'area under the curve (AUC) mean arterial pressure (MAP', 'Arterial catheter pressures']","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter (physical object)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0428890', 'cui_str': 'Invasive arterial pressure (observable entity)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0581447', 'cui_str': 'Arterial catheter (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",152.0,0.286559,"In the primary intent-to-treat analysis, catheter-based monitoring increased detection of AUC-MAP <65 mm Hg, with an estimated proportional odds ratio (ie, odds of being in a worse hypotension category) of 1.78 (95% confidence interval [CI], 1.18-2.70; P = .006).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Naylor', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Dongsheng', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mascha', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Suleiman', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reville', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Cote', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Hutcherson', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Bianka M', 'Initials': 'BM', 'LastName': 'Nguyen', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elsharkawy', 'Affiliation': 'From the Departments of Outcomes Research.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'From the Departments of Outcomes Research.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004370']
884,31490310,Quantification of Erythema Associated With Continuous Versus Interrupted Nylon Sutures in Facial Surgery Repair: A Randomized Prospective Study.,"BACKGROUND
Patients are often concerned about the cosmetic appearance of scars following Mohs micrographic surgery (MMS), including residual erythema. However, few studies have compared the cosmetic outcomes between different suturing techniques.
OBJECTIVE
To compare the erythema intensity (EI) associated with interrupted sutures (IS) and continuous sutures (CS), and the degree of its reduction over time.
MATERIALS AND METHODS
Mohs micrographic surgery patients were randomized to have half of their defect repaired with IS and the other half with CS. Postoperatively, subjects were assessed at 1 week, 2 months, and 6 months and close-up photographs of their scars were taken. Computer-assisted image analysis was utilized to quantify the EI in each half-scar.
RESULTS
The average EI of IS was greater than that of CS by 9.3% at 1 week (p < .001) and 7.2% at 2 months (p < .021) but comparable at 6 months. These differences were clinically detectable, but EI differences resolved by 6 months in most cases. At 6 months, EI regressed by 33.5% in IS and 26.3% in CS.
CONCLUSION
Continuous sutures are associated with less erythema during early scar maturation but are comparable to IS at 6 months. These results may guide the choice of suturing technique to improve early cosmetic outcomes and overall patient satisfaction.",2020,The average EI of IS was greater than that of CS by 9.3% at 1 week (p < .001) and 7.2% at 2 months (p < .021) but comparable at 6 months.,"['Facial Surgery Repair', 'Mohs micrographic surgery patients']","['micrographic surgery (MMS', 'interrupted sutures (IS) and continuous sutures (CS', 'Continuous Versus Interrupted Nylon Sutures']","['Quantification of Erythema', 'average EI of IS', 'erythema during early scar maturation', 'erythema intensity (EI']","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0443239', 'cui_str': 'Interrupted (qualifier value)'}, {'cui': 'C0183734', 'cui_str': 'Nylon suture, device (physical object)'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",,0.0281273,The average EI of IS was greater than that of CS by 9.3% at 1 week (p < .001) and 7.2% at 2 months (p < .021) but comparable at 6 months.,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Majd', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Ardalan', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zloty', 'Affiliation': 'Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002145']
885,30035583,More than my RA: A randomized trial investigating body image improvement among women with rheumatoid arthritis using a functionality-focused intervention program.,"OBJECTIVE
Negative body image is prevalent in women with rheumatoid arthritis and can affect other areas of well-being. Patients have expressed desire for body image to be addressed in treatment. Yet, it is not routinely addressed and no experimental intervention research has been conducted, until now. This randomized trial evaluated a brief online body image intervention for women with rheumatoid arthritis, with a focus on body functionality (everything the body is capable of doing) as the primary technique.
METHOD
Women with rheumatoid arthritis and who wanted to feel better about their body (N = 84; M age = 44.82) were randomized to the Expand Your Horizon intervention (comprising 3 writing exercises focusing on body functionality) or a waitlist control group. Primary outcomes concerned body image and secondary outcomes related to rheumatoid arthritis; these outcomes were assessed at pretest, posttest, and at 1-week and 1-month follow-up.
RESULTS
Multilevel modeling analyses showed that, relative to control, participants in the intervention experienced improvements in various aspects of body image (functionality appreciation, body appreciation, body satisfaction, body-self alienation) and decreases in depression, with effects persisting at 1-week and 1-month follow-up. No intervention effects were found for body-self harmony, rheumatoid arthritis-specific disability, pain-related disability, and anxiety.
CONCLUSIONS
Focusing on body functionality can improve body image and reduce depression in women with rheumatoid arthritis. The intervention technique is easy and affordable to deliver and could be a fruitful addition to extant treatments for rheumatoid arthritis. (PsycINFO Database Record",2018,"No intervention effects were found for body-self harmony, rheumatoid arthritis-specific disability, pain-related disability, and anxiety.
","['Women with rheumatoid arthritis and who wanted to feel better about their body (N = 84; M age = 44.82', 'women with rheumatoid arthritis']","['my RA', 'Your Horizon intervention (comprising 3 writing exercises focusing on body functionality) or a waitlist control group', 'online body image intervention']","['body image and secondary outcomes related to rheumatoid arthritis', 'body-self harmony, rheumatoid arthritis-specific disability, pain-related disability, and anxiety', 'various aspects of body image (functionality appreciation, body appreciation, body satisfaction, body-self alienation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}]","[{'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",3.0,0.051079,"No intervention effects were found for body-self harmony, rheumatoid arthritis-specific disability, pain-related disability, and anxiety.
","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Alleva', 'Affiliation': ''}, {'ForeName': 'Phillippa C', 'Initials': 'PC', 'LastName': 'Diedrichs', 'Affiliation': 'Centre for Appearance Research, University of the West of England.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Halliwell', 'Affiliation': 'Centre for Appearance Research, University of the West of England.'}, {'ForeName': 'Madelon L', 'Initials': 'ML', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dures', 'Affiliation': 'Academic Rheumatology, Bristol Royal Infirmary.'}, {'ForeName': 'Bobby G', 'Initials': 'BG', 'LastName': 'Stuijfzand', 'Affiliation': 'Jean Golding Institute, University of Bristol.'}, {'ForeName': 'Nichola', 'Initials': 'N', 'LastName': 'Rumsey', 'Affiliation': 'Centre for Appearance Research, University of the West of England.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000317']
886,31489742,The REMEDEE trial: 5-Year results on a novel combined sirolimus-eluting and endothelial progenitor cells capturing stent.,"OBJECTIVES
To evaluate the long-term safety and efficacy of the novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL) at 5 years in the REMEDEE (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coated bio-Engineered stEnt) trial.
BACKGROUND
Drug-eluting stents have limited restenosis and reintervention but are complicated by late and very late thrombosis and accelerated neoatherosclerosis. Alternative or adjunctive technologies are needed to address these limitations.
METHODS
A total of 183 patients with de novo lesions in native coronary arteries were randomized 2:1 to Combo (n = 124) or Taxus Liberté (n = 59). Primary endpoint was 9 month angiographic in-stent late lumen loss and the secondary endpoint was the occurrence of major adverse events (MACE) through 5-year follow-up.
RESULTS
Compared with Taxus, after 5 years the Combo stent was associated with similar rates of MACE (18.3% vs. 16.9%, p = .89), cardiac death (0.8% vs. 5.1%, p = .07), myocardial infarction (4.1% vs. 3.4%, p = .81), target lesion (9.4% vs. 10.2%, p = .78), and target vessel revascularization (14.4% vs. 11.9%, p = .73). No cases of definite stent thrombosis were reported in the Combo group. The follow-up rate at 5 years was 97.7%.
CONCLUSION
At 5-year follow-up, the Combo stent remained clinically safe and effective with an overall low rate of MACE comparable to Taxus.",2020,No cases of definite stent thrombosis were reported in the Combo group.,['183 patients with de novo lesions in native coronary arteries'],"['abluMinal sirolimus coated bio-Engineered stEnt', 'novel combined sirolimus-eluting and endothelial progenitor cells capturing stent', 'Taxus Liberté', 'Combo', 'novel combined sirolimus-eluting endothelial progenitor cell capture Combo stent (OrbusNeich, Fort Lauderdale, FL']","['safety and effectiveness', 'rates of MACE', 'occurrence of major adverse events (MACE) through 5-year follow-up', 'cardiac death', 'definite stent thrombosis', '9 month angiographic in-stent late lumen loss', 'myocardial infarction', 'target lesion', 'target vessel revascularization']","[{'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",183.0,0.0462759,No cases of definite stent thrombosis were reported in the Combo group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': 'Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.'}, {'ForeName': 'Stephen W L', 'Initials': 'SWL', 'LastName': 'Lee', 'Affiliation': 'Queen Mary Hospital, Hong Kong, Hong Kong.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Worthley', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Sigmund', 'Initials': 'S', 'LastName': 'Silber', 'Affiliation': 'Cardiology Practice and Hospital, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Verheye', 'Affiliation': 'Ziekenhuis Netwerk Antwerpen Middelheim, Antwerp, Belgium.'}, {'ForeName': 'Mohd A', 'Initials': 'MA', 'LastName': 'Rosli', 'Affiliation': 'Institut Jantung Negara, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Botelho', 'Affiliation': 'Instituto de Cardilogia de Triangulo Mineiro, Minas Gerais, Brazil.'}, {'ForeName': 'Kui H', 'Initials': 'KH', 'LastName': 'Sim', 'Affiliation': 'Sarawak Heart Centre, Sarawak, Malaysia.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Abizaid', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28483']
887,31858264,Long-term outcome of children and adolescents with obsessive-compulsive disorder: a 7-9-year follow-up of a randomized clinical trial.,"Pediatric obsessive-compulsive disorder (OCD) is an impairing disorder frequently associated with long-term persistence. Long-term follow-up studies that investigated psychopathological trajectories after initial treatment are scarce. The present study is a 7-9-year follow-up of a randomized clinical trial (RCT) that tested the efficacy of group cognitive-behavioral therapy (CBT) and sertraline for children with OCD (n = 40), and aimed to describe long-term outcomes of pediatric OCD and identify predictors of these outcomes. Thirty-five participants who were included in the original study were recruited for follow-up evaluations. Participants underwent a comprehensive assessment of demographic and clinical characteristics comprised of the Structured Clinical Interview for DSM Disorders (SCID) and/or Kiddie-Schedule of Affective Disorders and Schizophrenia Present-Lifetime (K-SADS-PL), and the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Thirty-three participants had a complete psychiatric assessment at follow-up (mean age 21 years, SD 3.2; 65% male). At follow-up, 13 (39.4%) participants had an OCD diagnosis, 10 (30.3%) had a diagnosis of any mental disorder (excluding OCD), and 10 (30.3%) did not have any diagnosis of mental disorder. In total, 23 participants (69.7%) had at least one mental disorder (including OCD). Among those without OCD (n = 20), 60.6% had a mental disorder. The following characteristics at follow-up were associated with OCD diagnosis: YBOCS total score (p < 0.001), global functioning (p = 0.008), and presence of any anxiety disorder (p = 0.027). Being treated with GCBT or sertraline during the original RCT did not predict OCD at follow-up. New treatment strategies should consider the role of psychopathological trajectories using a dynamic approach to combine or change interventions to enhance prognosis.",2020,"The following characteristics at follow-up were associated with OCD diagnosis: YBOCS total score (p < 0.001), global functioning (p = 0.008), and presence of any anxiety disorder (p = 0.027).","['Participants underwent a comprehensive assessment of demographic and clinical characteristics comprised of the Structured Clinical Interview for DSM Disorders (SCID) and/or Kiddie-Schedule of Affective Disorders and Schizophrenia Present', 'children with OCD (n\u2009=\u200940', 'Pediatric obsessive-compulsive disorder (OCD', 'Thirty-five participants who were included in the original study were recruited for follow-up evaluations', 'children and adolescents with obsessive-compulsive disorder', '23 participants (69.7%) had at least one mental disorder (including OCD', 'Thirty-three participants had a complete psychiatric assessment at follow-up (mean age 21\xa0years, SD 3.2; 65% male']","['GCBT or sertraline', 'group cognitive-behavioral therapy (CBT) and sertraline']","['OCD diagnosis: YBOCS total score', 'presence of any anxiety disorder', 'global functioning', 'diagnosis of any mental disorder (excluding OCD', 'Yale-Brown Obsessive-Compulsive Scale (YBOCS', 'OCD diagnosis']","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}]",35.0,0.0635189,"The following characteristics at follow-up were associated with OCD diagnosis: YBOCS total score (p < 0.001), global functioning (p = 0.008), and presence of any anxiety disorder (p = 0.027).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatori', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil. daniel.fatori@gmail.com.'}, {'ForeName': 'Guilherme V', 'Initials': 'GV', 'LastName': 'Polanczyk', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Rosa Magaly Campelo Borba', 'Initials': 'RMCB', 'LastName': 'de Morais', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Fernando R', 'Initials': 'FR', 'LastName': 'Asbahr', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, São Paulo, Brazil.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01457-8']
888,32103310,"A commentary on ""Impact of postoperative instructions on physical activity following pelvic reconstructive surgery: a randomized controlled trial"".",,2020,,['pelvic reconstructive surgery'],['postoperative instructions'],['physical activity'],"[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.220389,,"[{'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Rostaminia', 'Affiliation': 'NorthShore University HealthSystem, Skokie, IL, USA. ghazalerostaminia@yahoo.com.'}]",International urogynecology journal,['10.1007/s00192-020-04269-6']
889,29781648,A mobile app for social anxiety disorder: A three-arm randomized controlled trial comparing mobile and PC-based guided self-help interventions.,"OBJECTIVE
Internet-based cognitive-behavioral treatments (ICBT) have shown promise for various mental disorders, including social anxiety disorder (SAD). Most of these treatments have been delivered on desktop computers. However, the use of smartphones is becoming ubiquitous and could extend the reach of ICBT into users' everyday life. Only a few studies have empirically examined the efficacy of ICBT delivered through a smartphone app and there is no published study on mobile app delivered ICBT for SAD. This three-arm randomized-controlled trial (RCT) is the first to compare the efficacy of guided ICBT for smartphones (app) and conventional computers (PC) with a wait list control group (WL).
METHOD
A total of 150 individuals meeting the diagnostic criteria for SAD were randomly assigned to one of the three conditions. Primary endpoints were self-report measures and diagnostic status of SAD.
RESULTS
After 12 weeks of treatment, both active conditions showed superior outcome on the composite of all SAD measures (PC vs. WL: d = 0.74; App vs. WL: d = 0.89) and promising diagnostic response rates (NNTPC = 3.33; NNTApp = 6.00) compared to the WL. No significant between-groups effects were found between the two active conditions on the composite score (Cohen's d = 0.07). Treatment gains were maintained at 3-month follow-up. Program use was more evenly spread throughout the day in the mobile condition, indicating an integration of the program into daily routines.
CONCLUSIONS
ICBT can be delivered effectively using smartphones. (PsycINFO Database Record",2018,No significant between-groups effects were found between the two active conditions on the composite score (Cohen's d = 0.07).,"['150 individuals meeting the diagnostic criteria for SAD', 'social anxiety disorder']","['Internet-based cognitive-behavioral treatments (ICBT', 'mobile and PC-based guided self-help interventions', 'guided ICBT for smartphones (app) and conventional computers (PC) with a wait list control group (WL', 'ICBT']","['diagnostic response rates', 'self-report measures and diagnostic status of SAD', 'composite of all SAD measures', 'composite score']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",150.0,0.0536632,No significant between-groups effects were found between the two active conditions on the composite score (Cohen's d = 0.07).,"[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Stolz', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Ava', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Urech', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Westermann', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000301']
890,31495881,Choice of endpoint in kidney outcome trials: considerations from the EMPA-REG OUTCOME® trial.,"BACKGROUND
Doubling of serum creatinine [equivalent to 57% reduction in estimated glomerular filtration rate (eGFR)] is an established surrogate for end-stage kidney disease (ESKD); however, this endpoint necessitates lengthy follow-up and large sample sizes in clinical trials. We explored whether alternative eGFR decline thresholds provide more feasible surrogate kidney endpoints.
METHODS
The study involved post hoc analysis of the EMPA-REG OUTCOME® trial. Adults with type 2 diabetes, high cardiovascular risk and eGFR ≥30 mL/min/1.73 m2 were assigned empagliflozin 10 mg or 25 mg (n = 4687) or placebo (n = 2333), on top of standard of care. We assessed composite endpoints incorporating different eGFR decline thresholds (≥30, ≥40, ≥50 or ≥57%) combined with initiation of renal replacement therapy (RRT) or renal death. This trial is registered with ClinicalTrials.gov (NCT01131676).
RESULTS
Empagliflozin versus placebo significantly lowered the risk of decline in eGFR for each threshold listed above, combined with initiation of RRT or renal death, ranging from a hazard ratio (HR) of 0.81 [95% confidence interval (CI) 0.72-0.91] for endpoints based on 30% eGFR decline to an HR of 0.37 (0.23-0.61) for endpoints based on 57% eGFR decline. Lower thresholds (e.g. 30%) were associated with higher event rates but weaker treatment effects. The time to the 95% CI of the HR falling to <1.0 decreased with increasing eGFR threshold.
CONCLUSIONS
The composite of 40% decline in eGFR, ESKD or renal death appears to provide reliable results similar to the traditional 57% decline in eGFR.",2020,"The composite of 40% decline in eGFR, ESKD or renal death appears to provide reliable results similar to the traditional 57% decline in eGFR.","['Adults with type 2 diabetes, high cardiovascular risk and eGFR ≥30']","['placebo', 'Empagliflozin', 'empagliflozin']","['eGFR, ESKD or renal death', 'renal replacement therapy (RRT) or renal death', 'glomerular filtration rate (eGFR', 'risk of decline in eGFR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Kidney Replacement Therapy'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.515188,"The composite of 40% decline in eGFR, ESKD or renal death appears to provide reliable results similar to the traditional 57% decline in eGFR.","[{'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Koitka-Weber', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Australia.'}, {'ForeName': 'Guntram', 'Initials': 'G', 'LastName': 'Schernthaner', 'Affiliation': 'Rudolfstiftung Hospital Vienna, Department of Medicine, Vienna, Austria.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Pfarr', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Woerle', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'von Eynatten', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Würzburg University Clinic, Würzburg, Germany.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz179']
891,32436641,"Ultra rapid lispro lowers postprandial glucose and more closely matches normal physiological glucose response compared to other rapid insulin analogues: A phase 1 randomized, crossover study.","AIMS
To compare the pharmacokinetic (PK) and glucodynamic (GD) characteristics of ultra rapid lispro (URLi; Eli Lilly and Company, Indianapolis, Indiana), Fiasp® (Novo Nordisk, Bagsvaerd, Denmark), Humalog® (Eli Lilly and Company) and NovoRapid® (Novo Nordisk), in patients with type 1 diabetes (T1D).
MATERIALS AND METHODS
This was a randomized, double-blind, four-period, crossover study, conducted in 68 patients with T1D. Patients received the same individualized subcutaneous dose of each study drug immediately prior to a liquid test meal. For comparison, 12 healthy subjects received the same test meal.
RESULTS
URLi had a significantly faster insulin absorption compared to the other insulins tested. Early half-maximal drug concentration was reached 13 minutes after administration of URLi, which was 6 minutes faster than Fiasp, 13 minutes faster than Humalog, and 14 minutes faster than NovoRapid (all P <0.0001). Early insulin exposure was significantly greater and late insulin exposure was reduced after URLi compared to the other insulins. URLi achieved the greatest numerical reduction in postprandial glucose (PPG) at 2 hours post-meal (7 mg/dL vs Fiasp) and was significantly different from Humalog (21 mg/dL) and Novo Rapid (29 mg/dL). Additionally, glucose excursions over the first 3 hours post-meal with URLi were comparable to those in healthy subjects.
CONCLUSIONS
URLi demonstrated the fastest insulin absorption and the greatest numeric PPG-lowering effect compared to the other insulins tested. URLi more closely matched the early physiological glucose control observed in healthy subjects.",2020,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"['68 patients with T1D. Patients', 'patients with type 1 diabetes (T1D', '12 healthy subjects', 'healthy subjects']","['URLi', 'pharmacokinetics (PK) and glucocodynamics (GD) of URLi, Fiasp®, Humalog®, and NovoRapid®', 'Ultra rapid lispro (URLi']","['Ultra Rapid Lispro Lowers Postprandial Glucose and More Closely Matches Normal Physiological Glucose Response', 'insulin absorption', 'maximal drug concentration', 'glucose excursions', 'postprandial glucose (PPG) control', 'late insulin exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4529885', 'cui_str': 'Fiasp'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0939412', 'cui_str': 'NovoRapid'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",68.0,0.0670366,URLi achieved the greatest numerical reduction in PPG at 2 hours post-meal (7 mg/dL vs Fiasp) and significant differences to Humalog (21 mg/dL) and Novo Rapid (29 mg/dL).,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kapitza', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14094']
892,31473331,A randomized controlled trial of a smoking cessation self-help intervention for Spanish-speaking Hispanic/Latinx smokers: Study design and baseline characteristics.,"Although the current smoking prevalence among Hispanics/Latinxs (10%) is lower than in non-Hispanic whites (15%), higher prevalence is observed among certain subgroups (e.g., Puerto Rican males, 19%). Hispanic/Latinx smokers face unique challenges such as lower awareness and acceptability of nicotine replacement aids, lower prevalence of using counseling or medication, and receiving less advice to quit by their health care providers. Despite these barriers to smoking cessation, few interventions specifically targeted to Hispanic/Latinx smokers have been developed and evaluated. This paper summarizes the design, methods, analysis plan, and sample baseline characteristics of an ongoing randomized controlled trial to assess the efficacy of a Spanish-language self-help smoking cessation intervention among Hispanics/Latinxs. Current smokers who prefer health education materials in Spanish were randomized to one of two conditions. The usual care group received a standard smoking cessation booklet developed by the National Cancer Institute. The intervention group received 10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18 months. All participants complete self-report surveys every 6 months over 2 years. Smoking abstinence is biochemically verified at 12- and 24-month follow-up. A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study. The primary outcome is self-reported 7-day point prevalence abstinence. If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.",2019,"If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.","['A total of 2387 smokers were screened, 2056 were eligible and 1417 were enrolled in the study', 'Hispanic/Latinx smokers', 'Current smokers who prefer health education materials in Spanish', 'Spanish-speaking Hispanic/Latinx smokers', 'Hispanics/Latinxs']","['smoking cessation self-help intervention', 'Spanish-language self-help smoking cessation intervention', 'standard smoking cessation booklet', '10 booklets, 9 pamphlets and a booklet for family and friends mailed monthly over 18\u202fmonths']","['self-reported 7-day point prevalence abstinence', 'Smoking abstinence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C3241966'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0018701'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037750', 'cui_str': 'Spanish language (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",2056.0,0.0207541,"If the intervention is deemed efficacious, it has potential to have a large public health impact with respect to reducing smoking rates and smoking related morbidity and mortality among a large underserved minority population.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Medina-Ramírez', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Úrsula', 'Initials': 'Ú', 'LastName': 'Martínez', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Byrne', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Fiorella M', 'Initials': 'FM', 'LastName': 'Gonzales', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, FL, USA; University of South Florida, USA. Electronic address: Vani.Simmons@Moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105836']
893,31500679,"LSD acutely impairs working memory, executive functions, and cognitive flexibility, but not risk-based decision-making.","BACKGROUND
Psychiatric and neurodegenerative illnesses are characterized by cognitive impairments, in particular deficits in working memory, decision-making, and executive functions including cognitive flexibility. However, the neuropharmacology of these cognitive functions is poorly understood. The serotonin (5-HT) 2A receptor might be a promising candidate for the modulation of cognitive processes. However, pharmacological studies investigating the role of this receptor system in humans are rare. Recent evidence demonstrates that the effects of Lysergic acid diethylamide (LSD) are mediated via agonistic action at the 5-HT2A receptor. Yet, the effects of LSD on specific cognitive domains using standardized neuropsychological test have not been studied.
METHODS
We examined the acute effects of LSD (100 µg) alone and in combination with the 5-HT2A antagonist ketanserin (40 mg) on cognition, employing a double-blind, randomized, placebo-controlled, within-subject design in 25 healthy participants. Executive functions, cognitive flexibility, spatial working memory, and risk-based decision-making were examined by the Intra/Extra-Dimensional shift task (IED), Spatial Working Memory task (SWM), and Cambridge Gambling Task (CGT) of the Cambridge Neuropsychological Test Automated Battery.
RESULTS
Compared to placebo, LSD significantly impaired executive functions, cognitive flexibility, and working memory on the IED and SWM, but did not influence the quality of decision-making and risk taking on the CGT. Pretreatment with the 5-HT2A antagonist ketanserin normalized all LSD-induced cognitive deficits.
CONCLUSIONS
The present findings highlight the role of the 5-HT2A receptor system in executive functions and working memory and suggest that specific 5-HT2A antagonists may be relevant for improving cognitive dysfunctions in psychiatric disorders.",2020,"Compared to placebo, LSD significantly impaired executive functions, cognitive flexibility, and working memory on the IED and SWM, but did not influence the quality of decision-making and risk taking on the CGT.",['25 healthy participants'],"['LSD', 'LSD (100 µg) alone and in combination with the 5-HT2A antagonist ketanserin', 'placebo', 'placebo, LSD', 'Lysergic acid diethylamide (LSD', '5-HT2A antagonist ketanserin']","['executive functions, cognitive flexibility, and working memory on the IED and SWM', 'quality of decision-making and risk taking on the CGT', 'Executive functions, cognitive flexibility, spatial working memory, and risk-based decision-making', 'Intra/Extra-Dimensional shift task (IED), Spatial Working Memory task (SWM), and Cambridge Gambling Task (CGT) of the Cambridge Neuropsychological Test Automated Battery', 'working memory, executive functions, and cognitive flexibility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2936524', 'cui_str': '5-HT2A Antagonist'}, {'cui': 'C0022616', 'cui_str': 'Ketanserin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C4505411', 'cui_str': 'Cambridge Neuropsychological Test Automated Battery'}]",25.0,0.0498576,"Compared to placebo, LSD significantly impaired executive functions, cognitive flexibility, and working memory on the IED and SWM, but did not influence the quality of decision-making and risk taking on the CGT.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pokorny', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duerler', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}]",Psychological medicine,['10.1017/S0033291719002393']
894,32439135,"Effect of supportive counseling on pregnancy-specific stress, general stress, and prenatal health behaviors: A multicenter randomized controlled trial.","OBJECTIVE
The aim of this study was to investigate the effects of group supportive counseling (SC) on pregnancy-specific stress, general stress, and healthy behavior of pregnant women.
METHODS
This randomized controlled trial study was conducted on 80 pregnant women in two groups; SC for six sessions, once a week for two hours (n = 40), and antenatal usual care (AUC) (n = 40). All Participants completed questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol at pre-intervention and 6-week post-intervention.
RESULTS
The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size. Also, healthy behaviors were promoted more significantly in SC group than in AUC. However, salivary cortisol levels did not differ between group SC and AUC groups.
CONCLUSION
Group supportive counselling can promote pregnancy stress and healthy behaviors.
PRACTICE IMPLICATIONS
Addition of supportive counseling to prenatal usual care may be suggested for pregnant women with any gestational age who seek methods for improving pregnancy stress and healthy behaviors.",2020,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","['pregnant women with any gestational age', '80 pregnant women in two groups', 'pregnant women']","['group supportive counseling (SC', 'antenatal usual care (AUC', 'SC', 'supportive counseling']","['pregnancy stress and healthy behaviors', 'pregnancy-specific stress, general stress, and healthy behavior', 'total NuPDQ, for state-anxiety', 'pregnancy-specific stress, general stress, and prenatal health behaviors', 'salivary cortisol levels', 'questionnaires measuring pregnancy-specific stress, state anxiety, prenatal health behaviors, perceived stress, and provided a saliva sample for measurement of cortisol', 'healthy behaviors']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1321108', 'cui_str': 'Prenatal health behavior'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",80.0,0.0769546,"The post-intervention results indicated that the outcome scores decreased more significantly in group SC than in the AUC for total NuPDQ, for state-anxiety, for PSS-14, and for unhealthy behaviors with a large effect size.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Esfandiari', 'Affiliation': 'Student Research Committee, Babol University of Medical Sciences, Babol, Iran. Electronic address: maryeikimm@gmail.com.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: mahbob330@yahoo.com.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Nasiri-Amiri', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, IR Iran. Electronic address: nasiri_fa@yahoo.com.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Parsian', 'Affiliation': 'Cellular and Molecular Biology Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: hadiparsian@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Chehrazi', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, Babol University of Medical Sciences, Babol, Iran. Electronic address: mohamadchehrazi@gmail.com.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Pasha', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: dhajarpasha@gmail.com.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Omidvar', 'Affiliation': 'Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: shomidvar@yahoo.com.'}, {'ForeName': 'Hemmat', 'Initials': 'H', 'LastName': 'Gholinia', 'Affiliation': 'Social Determinants of Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. Electronic address: h_gholonia@yahoo.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.04.024']
895,31488427,Selective laser trabeculoplasty versus topical medication as initial glaucoma treatment: the glaucoma initial treatment study randomised clinical trial.,"BACKGROUND/AIMS
To determine if selective laser trabeculoplasty (SLT) is superior to topical medication as a first-line treatment for glaucoma on quality of life (QoL) and clinical outcomes.
METHODS
In this international, longitudinal, multisite randomised controlled trial, treatment naïve mild-to-moderate primary open angle or exfoliation glaucoma patients were randomised 1:1 to SLT or topical medication. Glaucoma-specific QoL (primary outcome) was measured using the Glaucoma Outcomes Assessment Tool (GOAT; 342 items, 12 domains). Secondary outcomes included rate of successful intraocular pressure (IOP) reduction (>25% reduction from baseline) and presence of ocular surface disease including conjunctival hyperaemia and eyelid erythema. Our intention-to-treat analysis was performed at months 12 and 24.
RESULTS
Of 167 enrolled patients, 83 and 84 were randomised to SLT and topical medication, respectively; and 145 (n=75 SLT, n=70 medication) completed 24-month follow-up. While both treatment arms achieved significant within-group gains in GOAT outcomes at both endpoints, SLT patients reported a greater between-group improvement in 'social well-being' compared with medication patients (mean±SE=0.28±0.13; p=0.034) at 24 months. At month 24, the rate of successful IOP reduction was 18.6% (95% CI 3.0% to 34.3%, p=0.022) higher (absolute difference) in the medication compared with SLT group. More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.
CONCLUSION
Overall, we did not find evidence that SLT was superior to medication in improving glaucoma-specific QoL. While we found superior IOP reduction in the medication arm, eyelid erythema and conjunctival hyperaemia were more prevalent in these patients compared with the SLT group.
TRIAL REGISTRATION
ACTRN12611000720910.",2020,"More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.
","['initial glaucoma treatment', '167 enrolled patients, 83 and 84 were randomised to SLT and topical medication, respectively; and 145 ', 'naïve mild-to-moderate primary open angle or exfoliation glaucoma patients']","['SLT', 'SLT or topical medication', 'selective laser trabeculoplasty (SLT', 'Selective laser trabeculoplasty versus topical medication']","['social well-being', 'eyelid erythema and conjunctival hyperaemia', 'rate of successful IOP reduction', 'GOAT outcomes', 'presence of ocular surface disease including conjunctival hyperaemia and eyelid erythema', 'rate of successful intraocular pressure (IOP) reduction', 'conjunctival hyperaemia and eyelid erythema', 'superior IOP reduction']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0429524', 'cui_str': 'Angle open (finding)'}, {'cui': 'C0206368', 'cui_str': 'Glaucoma Capsulare'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1271447', 'cui_str': 'SLT - selective laser trabeculoplasty'}]","[{'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia (finding)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1510458', 'cui_str': 'Capras'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",167.0,0.147107,"More individuals in the medication group had conjunctival hyperaemia and eyelid erythema compared with SLT at 24 months.
","[{'ForeName': 'Ghee Soon', 'Initials': 'GS', 'LastName': 'Ang', 'Affiliation': 'Glaucoma Investigation and Research Unit, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Eva K', 'Initials': 'EK', 'LastName': 'Fenwick', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alfred Tau Liang', 'Initials': 'ATL', 'LastName': 'Gan', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Ryan Eyn Kidd', 'Initials': 'REK', 'LastName': 'Man', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Casson', 'Affiliation': 'Ophthalmology and Visual Sciences, South Australian Institute of Ophthalmology, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Finkelstein', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Goldberg', 'Affiliation': 'Discipline of Ophthalmology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Healey', 'Affiliation': 'Discipline of Ophthalmology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Pesudovs', 'Affiliation': 'School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sutha', 'Initials': 'S', 'LastName': 'Sanmugasundram', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'McIntosh', 'Affiliation': 'Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Jackson', 'Affiliation': 'National Vision Research Institute, Australian College of Optometry, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Wells', 'Affiliation': 'Capital Eye Specialists, Wellington, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'White', 'Affiliation': 'Discipline of Ophthalmology, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Glaucoma Investigation and Research Unit, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Walland', 'Affiliation': 'Glaucoma Investigation and Research Unit, Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Crowston', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore.'}, {'ForeName': 'Ecosse Luc', 'Initials': 'EL', 'LastName': 'Lamoureux', 'Affiliation': 'Singapore Eye Research Institute, Singapore National Eye Centre, Singapore ecosse@unimelb.edu.au.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2018-313396']
896,31490025,A large-scale transcriptome analysis identified ELANE and PRTN3 as novel methylation prognostic signatures for clear cell renal cell carcinoma.,"DNA methylation was involved in the progress of many types of cancer including clear cell renal cell carcinomas (ccRCCs). This study aimed to identify the prognostic DNA methylation biomarkers for the ccRCCs by a large-scale RNA-seq analysis. The DNA methylation data and the corresponding clinical information of the patients with ccRCCs were extracted from TCGA database and randomly divided into the training group and the validation group. The differentially expressed CpG sites and the survival-related CpG sites were further identified, which was combined into CpG sites pair and followed by screening the survival-related pairs. The C-index and the forward search algorithms were constructed to identify the prognostic signatures for the patients with ccRCCs. The prognostic signatures were verified by the validation dataset and the protein-protein interactions (PPI) network analysis was performed on the CPG sites of the signature. A total of 9,861 differentially expressed CPG sites were identified and 567 CpG sites were found to relate to the overall survival (OS) of the patients with ccRCCs. Besides, 1,146 CPG sites pairs were found to be related to the OS of the ccRCCs samples and the signature composed of seven CpG sites pairs were obtained to predict the prognosis of patients with ccRCCs and the results were verified in the validation dataset. Besides, the PPI network analysis showed that ELANE and PRTN3 gene may be associated with the invasion and metastasis of ccRCCs and could function as potential prognostic and therapeutic signatures for ccRCCs.",2020,"A total of 9,861 differentially expressed CPG sites were identified and 567 CpG sites were found to relate to the overall survival (OS) of the patients with ccRCCs.",['patients with\xa0ccRCCs'],['ELANE and PRTN3'],['overall survival (OS'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",1146.0,0.0131205,"A total of 9,861 differentially expressed CPG sites were identified and 567 CpG sites were found to relate to the overall survival (OS) of the patients with ccRCCs.","[{'ForeName': 'Zhongheng', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'Department of Oncology, Affiliated Hospital of Youjiang Medical University for Nationalities, Baise, Guangxi, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Department of Clinical Laboratory, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Fudan University, School of Medicine, Shanghai, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Rehabilitation, Huai'an Second People's Hospital, The Affiliated Huai'an Hospital of Xuzhou Medical University Huai'an, Huai'an, China.""}]",Journal of cellular physiology,['10.1002/jcp.29162']
897,31888947,Feasibility study of early outpatient review and early cardiac rehabilitation after cardiac surgery: mixed-methods research design-a study protocol.,"INTRODUCTION
Following cardiac surgery, patients currently attend an outpatient review 6 weeks after hospital discharge, where recovery is assessed and suitability to commence cardiac rehabilitation (CR) is determined. CR is then started from 8 weeks. Following a median sternotomy, cardiac surgery patients are required to refrain from upper body exercises, lifting of heavy objects and other strenuous activities for 12 weeks. A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration. However, current guidelines for activity and exercise after median sternotomy have been described as restrictive, anecdotal and increasingly at odds with modern clinical guidance for CR. This study aims to examine the feasibility of bringing forward outpatient review and starting CR earlier.
METHODS AND ANALYSES
This is a multicentre, randomised controlled, open feasibility trial comparing postoperative outpatient review 6 weeks after hospital discharge, followed by CR commencement from 8 weeks (control arm) versus, postoperative outpatient review 3 weeks after hospital discharge, followed by commencement of CR from 4 weeks (intervention arm). The study aims to recruit 100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres. Feasibility will be measured by consent, recruitment, retention rates and attendance at appointments and CR sessions. Qualitative interviews with trial participants and staff will explore issues around study processes and acceptability of the intervention and the findings integrated with the feasibility trial outcomes to inform the design of a future full-scale randomised controlled trial.
ETHICS AND DISSEMINATION
Ethics approval was granted by East Midlands-Derby Research Ethics Committee on 10 January 2019. The findings will be presented at relevant conferences disseminated via peer-reviewed research publications, and to relevant stakeholders.
TRIAL REGISTRATION NUMBER
ISRCTN80441309.",2019,"A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration.","['100 eligible patients, aged 18-80 years who have undergone elective or urgent cardiac surgery involving a full median sternotomy, over a 7-month period across two centres', 'early outpatient review and early cardiac rehabilitation after cardiac surgery']",['cardiac surgery'],[],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1282959', 'cui_str': 'Median Sternotomy'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]",[],,0.289059,"A delay in starting CR can prolong the recovery process, increase dependence on family/carers and can cause frustration.","[{'ForeName': 'Dumbor', 'Initials': 'D', 'LastName': 'Ngaage', 'Affiliation': 'Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust, Hull, UK dumbor.ngaage@hey.nhs.uk.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hirst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Akowuah', 'Affiliation': 'James Cook Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Patrick Joseph', 'Initials': 'PJ', 'LastName': 'Doherty', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Flemming', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hinde', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Nichols', 'Affiliation': 'Centre for Sport and Exercise Science, Sheffield Hallam University - Collegiate Crescent Campus, Sheffield, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Watson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035787']
898,32112593,Recruiting participants to an Internet-based eating disorder prevention trial: Impact of the recruitment strategy on symptom severity and program utilization.,"OBJECTIVE
Using data from a randomized controlled trial, we examined two different strategies to recruit participants for an indicated preventive intervention (StudentBodies-AN) for women at risk for anorexia nervosa and compared symptom severity and program utilization in participants recruited through each strategy.
METHOD
We recruited participants by announcing the study (a) in lectures at universities and handing out screening questionnaires (face-to-face recruitment) and (b) through different media channels, and the participants completed the screening questionnaire on our study website (media-based recruitment). We compared symptom severity and program utilization between the two groups.
RESULTS
A total of 4,646 women (face-to-face: 3,741, media-based: 905) were screened and 168 women (face-to-face: 114, media-based: 54) were randomized to the intervention. We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face. Also, participants recruited through media were more likely to log onto the program (χ 2 = 5.06; p = .029) and accessed more of the intervention.
DISCUSSION
Recruitment through media seems both more feasible and suitable to reach individuals in need of indicative prevention, and should be part of a multimodal recruitment package. Future studies should be explicitly designed to investigate the impact of recruitment modality on reach and effectiveness including cost-effectiveness analyses.",2020,"We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face.","['women at risk for anorexia nervosa and compared symptom severity and program utilization in participants recruited through each strategy', '4,646 women (face-to-face: 3,741, media-based: 905) were screened and 168 women (face-to-face: 114, media-based: 54', 'We recruited participants by announcing the study (a) in lectures at universities and handing out screening questionnaires (face-to-face recruitment) and (b) through different media channels, and the participants completed the screening questionnaire on our study website (media-based recruitment']",['preventive intervention (StudentBodies-AN'],"['symptom severity and program utilization', 'core behaviors and attitudes of disordered eating (EDE global score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",4646.0,0.0490366,"We found a statistically and clinically significant association between recruitment strategy and symptom severity: Participants who were recruited through media were more likely to fulfill the inclusion criteria (40.6% vs. 13.3%; p < .001) and endorsed significantly more frequently core behaviors and attitudes of disordered eating (EDE global score: 2.72 vs. 2.17, p < .05; Weight Concerns Scale [WCS] score: 66.05 vs. 56.40, p < .05) at baseline than participants recruited face-to-face.","[{'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Vollert', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'von Bloh', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Eiterich', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Beintner', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Hütter', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Craig Barr', 'Initials': 'CB', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jacobi', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}]",The International journal of eating disorders,['10.1002/eat.23250']
899,32434204,"A Prospective, Randomized, Open-Label Trial of Atorvastatin versus Rosuvastatin in the Prevention of Contrast-Induced Acute Kidney Injury, Worsened Renal Function at 30 Days, and Clinical Events After Acute Coronary Angiography: the PRATO-ACS-2 Study.","BACKGROUND/AIMS
Both high-dose atorvastatin and rosuvastatin have been shown to reduce contrast-induced acute kidney injury (AKI) occurrence and improve clinical outcomes in high-risk coronary patients undergoing angiographic procedures. However, there is a lack of head-to-head comparative studies on the effects of atorvastatin or rosuvastatin administered upon hospital admission in statin-naive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS).
METHODS
In this open-label, noninferiority study, we compared changes in renal function in 709 NSTE-ACS patients randomized to atorvastatin (80 mg upon admission followed by 40 mg/day) or rosuvastatin (40 mg upon admission followed by 20 mg/day). The primary end point was AKI (increase in serum creatinine ≥0.5 mg/dL or ≥25% above baseline within 72 h). Worsening renal function (WRF) (decrease of ≥25% in the glomerular filtration rate from baseline to 30 days), 30-day major adverse cardiovascular events, and 12-month myocardial infarction (MI) or death were also evaluated.
RESULTS
The AKI incidence was similar in the 2 groups (i.e., 8.2% with rosuvastatin and 7.6% with atorvastatin; absolute risk difference = 0.54; 90% CI -3.9 to 2.8), satisfying the noninferiority criteria. WRF occurred in 53 (7.5%) patients, 19 (34%) of whom had developed AKI. The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups. Both AKI and WRF were found to be closely associated with the 12-month cardiovascular outcome irrespectively of statin choice.
CONCLUSIONS
High-dose rosuvastatin or atorvastatin started upon hospital admission led to similar rates of AKI, 30-day renal function changes, and 12-month death or MI in NSTE-ACS patients who underwent an early invasive strategy (clinical trial registration: https://www.clinicaltrials.gov; unique identifier: NCT01870804).",2020,The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups.,"['709 NSTE-ACS patients randomized to', 'statin-naive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS', 'high-risk coronary patients undergoing angiographic procedures']","['Atorvastatin versus Rosuvastatin', 'atorvastatin', 'rosuvastatin', 'rosuvastatin or atorvastatin', 'atorvastatin and rosuvastatin', 'atorvastatin or rosuvastatin']","['Worsening renal function (WRF', 'rates of AKI, 30-day renal function changes, and 12-month death or MI', '30-day major adverse cardiovascular events, and 12-month myocardial infarction (MI) or death', 'rates of WRF and adverse events', 'AKI (increase in serum creatinine ≥0.5', 'WRF', 'AKI incidence']","[{'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.044536,The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Toso', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy, anna.toso@libero.it.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Leoncini', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Maioli', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tropeano', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Villani', 'Affiliation': 'Section of Biostatistics and Clinical Epidemiology, Department of Public Health, Neurosciences, Experimental and Forensic Medicine, Pavia University, Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bellandi', 'Affiliation': 'Division of Cardiology, Santo Stefano Hospital, Prato, Italy.'}]",Cardiorenal medicine,['10.1159/000506857']
900,32439861,Physiological and Behavioral Synchrony Predict Group Cohesion and Performance.,"Interpersonal synchrony contributes to social functioning in dyads, but it remains unknown how synchrony shapes group experiences and performance. To this end, we designed a novel group drumming task in which participants matched their drumming to either predictable or unpredictable tempos. Fifty-one three-person groups were randomly assigned to one of two conditions: synchronized or asynchronized drumming. Outcome measures included electrocardiograms and self-reports of group cohesion and synchrony. The drumming task elicited an increase in physiological synchrony between group members (specifically their hearts' interbeat intervals). We also found that physiological synchronization and behavioral synchronization predicted individuals' experience of group cohesion. Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together. The findings suggest that the behavioral and physiological consequences of synchronization contribute to the formation of group bonds and coordination. They also confirm that insights from translational social neuroscience can inform our knowledge of the development of cohesive and efficacious groups.",2020,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"['participants matched their drumming to either predictable or unpredictable tempos', 'Fifty-one three-person groups']",['synchronized or asynchronized drumming'],"['electrocardiograms and self-reports of group cohesion and synchrony', 'physiological synchrony']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0139198,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"[{'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel. Ilanit.gordon@biu.ac.il.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gilboa', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Milstein', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Haimovich', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Pinhasi', 'Affiliation': 'The Psychology Department, Rupin College, Emeq-Hefer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Siegman', 'Affiliation': 'The Department of Computer Science, Bar Ilan University, Ramat-Gan, Israel.'}]",Scientific reports,['10.1038/s41598-020-65670-1']
901,31469671,"The Effects of Logotherapy on Distress, Depression, and Demoralization in Breast Cancer and Gynecological Cancer Patients: A Preliminary Study.","BACKGROUND
Globally, cancer is the second leading cause of death. Breast cancer and gynecological cancer can damage patients' body image and lead to psychological distress, depression, and demoralization syndrome. No studies have explored the effect of logotherapy in gynecological cancer patients' psychological distress, depression, and demoralization.
OBJECTIVE
To evaluate the effects of logotherapy on distress, depression, and demoralization in breast cancer and gynecological cancer patients.
METHODS
A quasi-experimental design was used in this study, involving 61 breast cancer and gynecological cancer patients: 31 in the experimental group and 30 in the control group. Participants in the experimental group received logotherapy 4 to 6 times during the 12 weeks of intervention. Outcomes were measured by the (1) Distress Thermometer, (2) Patient Health Questionnaire, and (3) Demoralization Scale Mandarin Version (DS-MV).
RESULTS
Distress Thermometer did not differ between groups, but significant differences in favor of the intervention group were noted in the Patient Health Questionnaire (U = 674.500, P = .002); the DS-MV subcategories of loss of meaning (U = 706.500, P = .000), dysphoria (U = 673.000, P = .002), disheartenment (U = 670.000, P = .003), helplessness (U = 621.000, P = .022), and sense of failure (U = 629.500, P = .016); and the total score of the DS-MV (U = 728.500, P = .000).
CONCLUSION
Logotherapy was effective in the reduction of breast cancer and gynecological cancer patients' depression and demoralization.
IMPLICATIONS FOR PRACTICE
Clinical professionals could add logotherapy to the treatment for breast cancer and gynecological cancer patients to reduce their depression and demoralization.",2021,"RESULTS
Distress Thermometer did not differ between groups, but significant differences in favor of the intervention group were noted in the Patient Health Questionnaire (U = 674.500, P = .002); the DS-MV subcategories of loss of meaning (U = 706.500, P = .000), dysphoria (U = 673.000, P = .002), disheartenment (U = 670.000, P = .003), helplessness (U = 621.000, P = .022), and sense of failure (U = 629.500, P = .016); and the total score of the DS-MV (U = 728.500, P = .000).
","['61 breast cancer and gynecological cancer patients: 31 in the experimental group and 30 in the control group', ""breast cancer and gynecological cancer patients' depression and demoralization"", 'Breast Cancer and Gynecological Cancer Patients', 'breast cancer and gynecological cancer patients', 'gynecological cancer patients']","['logotherapy', 'Logotherapy']","['helplessness', 'DS-MV subcategories of loss of meaning', 'Patient Health Questionnaire', 'Distress, Depression, and Demoralization', 'sense of failure', 'total score of the DS-MV', 'distress, depression, and demoralization', 'psychological distress, depression, and demoralization', '1) Distress Thermometer, (2) Patient Health Questionnaire, and (3) Demoralization Scale Mandarin Version (DS-MV', 'dysphoria']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233498', 'cui_str': 'Demoralization (finding)'}]","[{'cui': 'C0204524', 'cui_str': 'Logotherapy'}]","[{'cui': 'C0150063', 'cui_str': 'Feeling powerless (finding)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233498', 'cui_str': 'Demoralization (finding)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0039818', 'cui_str': 'Thermometers'}, {'cui': 'C0222045'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0233477', 'cui_str': 'Dysphoric mood (finding)'}]",61.0,0.0212552,"RESULTS
Distress Thermometer did not differ between groups, but significant differences in favor of the intervention group were noted in the Patient Health Questionnaire (U = 674.500, P = .002); the DS-MV subcategories of loss of meaning (U = 706.500, P = .000), dysphoria (U = 673.000, P = .002), disheartenment (U = 670.000, P = .003), helplessness (U = 621.000, P = .022), and sense of failure (U = 629.500, P = .016); and the total score of the DS-MV (U = 728.500, P = .000).
","[{'ForeName': 'Fan-Ko', 'Initials': 'FK', 'LastName': 'Sun', 'Affiliation': 'Author Affiliations: Department of Nursing, I-Shou University (Drs Sun, Yao, and Chiang); Department of General Surgery, E-DA Cancer Hospital (Dr Hung); and Departments of Obstetrics & Gynecology (Dr Fu) and Nursing (Ms Tsai), E-DA Hospital, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Chao-Ming', 'Initials': 'CM', 'LastName': 'Hung', 'Affiliation': ''}, {'ForeName': 'YuChun', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ''}, {'ForeName': 'Chi-Feng', 'Initials': 'CF', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Pei-Jung', 'Initials': 'PJ', 'LastName': 'Tsai', 'Affiliation': ''}, {'ForeName': 'Chun-Ying', 'Initials': 'CY', 'LastName': 'Chiang', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000740']
902,31984620,Exposure-response relationships for the sodium-glucose co-transporter-2 inhibitor dapagliflozin with regard to renal risk markers.,"AIMS
To quantitate the consistency of an individual's plasma exposure to dapagliflozin upon re-exposure, and to investigate whether the individual's systemic exposure to dapagliflozin explains inter-individual variation in response to dapagliflozin with regard to multiple renal risk markers.
METHODS
Data were used from a crossover randomized clinical trial that assessed the albuminuria-lowering effect of dapagliflozin in 33 people with type 2 diabetes and elevated albuminuria. Fifteen participants were exposed twice to dapagliflozin. Trough plasma concentrations of dapagliflozin were measured for each participant at steady state. Dapagliflozin plasma concentrations were measured by liquid chromatography tandem mass spectrometry, and pharmacokinetic characteristics were simulated based on a population pharmacokinetic model. Linear mixed-effects models were used to quantify the exposure-response relationships.
RESULTS
The median plasma concentration after first and second exposure to dapagliflozin was 5.3 ng/mL vs 4.6 ng/mL, respectively (P = 0.78). Lin's concordance correlation coefficient between occasions was 0.73 (P < 0.0021). Every 100 ng.h/mL increment in area under the dapagliflozin plasma concentration curve was associated with a decrease in log-transformed urinary albumin:creatinine ratio (β = -5.9, P < 0.01), body weight (β = -0.3, P < 0.01) and estimated glomerular filtration rate (β = -0.7, P = 0.01) and an increase in urinary glucose excretion (β = 17.0, P < 0.001).
CONCLUSION
An individual's exposure to dapagliflozin is consistent upon re-exposure and correlates with pharmacodynamic response in renal risk markers.",2020,"RESULTS
Median plasma concentration after first and second exposure to dapagliflozin was 5.3 ng/ml vs 4.6 ng/ml respectively (p=0.78).",['33 patients with type 2 diabetes and elevated albuminuria'],"['dapagliflozin', 'sodium-glucose co-transporter 2 inhibitor dapagliflozin', 'Dapagliflozin']","['dapagliflozin plasma concentration curve', 'renal risk markers', 'eGFR', 'body weight', 'log transformed urinary albumin:creatinine ratio', 'Trough plasma concentrations of dapagliflozin', 'Median plasma concentration', 'Dapagliflozin plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",33.0,0.075259,"RESULTS
Median plasma concentration after first and second exposure to dapagliflozin was 5.3 ng/ml vs 4.6 ng/ml respectively (p=0.78).","[{'ForeName': 'Marjolein Y A M', 'Initials': 'MYAM', 'LastName': 'Kroonen', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen V', 'Initials': 'JV', 'LastName': 'Koomen', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sergei I', 'Initials': 'SI', 'LastName': 'Petrykiv', 'Affiliation': 'Department of Psychiatric and Mental Healthcare, West Noord Brabant, The Netherlands.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Nephrology, Ziekenhuis Groep Twente, Almelo and Hengelo, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13976']
903,32439823,Slowed Metabolic Decline After 1 Year of Oral Insulin Treatment Among Individuals at High Risk for Type 1 Diabetes in the Diabetes Prevention Trial-Type 1 (DPT-1) and TrialNet Oral Insulin Prevention Trials.,"We assessed whether oral insulin slowed metabolic decline after 1 year of treatment in individuals at high risk for type 1 diabetes. Two oral insulin trials that did not show efficacy overall and had type 1 diabetes as the primary end point were analyzed: the Diabetes Prevention Trial-Type 1 (DPT-1) and the TrialNet oral insulin trials. Oral glucose tolerance tests at baseline and after 1 year of treatment were analyzed. Among those at high risk (with a Diabetes Prevention Trial-Type 1 Risk Score [DPTRS] ≥6.75), the area under the curve (AUC) C-peptide increased significantly from baseline to 1 year in each oral insulin group, whereas the AUC glucose increased significantly in each placebo group. At 1 year, the AUC C-peptide/AUC glucose (AUC Ratio) was significantly higher in the oral insulin group than in the placebo group in each trial ( P < 0.05; P = 0.057 when adjusted for age in the TrialNet trial) and in both trials combined ( P < 0.01 with or without adjustment for age). For a DPTRS <6.75, oral insulin groups did not differ from placebo groups in the AUC Ratio. The findings suggest that 1 year of treatment with oral insulin slows metabolic deterioration in individuals at high risk for type 1 diabetes. Moreover, the findings further suggest that metabolic end points can be useful adjuncts to the diagnostic end point in assessments of preventive treatments for the disorder.",2020,AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial,['individuals at high risk for type 1 diabetes'],"['oral insulin', 'placebo']","['AUC glucose', 'Slowed Metabolic Decline', 'AUC C-peptide', 'Oral glucose tolerance tests']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",,0.112215,AUC glucose was significantly higher (p<0.05) in the oral insulin group than in the placebo group in each trial,"[{'ForeName': 'Jay M', 'Initials': 'JM', 'LastName': 'Sosenko', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL jsosenko@med.miami.edu.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Desmond A', 'Initials': 'DA', 'LastName': 'Schatz', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': 'University of Florida Diabetes Institute, Gainesville, FL.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pugliese', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cleves', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Geyer', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Rafkin', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Della', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes,['10.2337/db20-0166']
904,31420350,Cardiovascular Safety and All-Cause Mortality of Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents in Anemia of CKD: A Randomized Noninferiority Trial.,"BACKGROUND AND OBJECTIVES
Erythropoiesis-stimulating agents correct anemia of CKD but may increase cardiovascular risk. We compared cardiovascular outcomes and all-cause mortality associated with monthly methoxy polyethylene glycol-epoetin beta with those of the shorter-acting agents epoetin alfa/beta and darbepoetin alfa in patients with anemia of CKD.
DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS
We conducted a multicenter, open-label, noninferiority trial in which patients were randomized to receive methoxy polyethylene glycol-epoetin beta or reference erythropoiesis-stimulating agents, stratified by maintenance or correction treatment status and C-reactive protein level. The trial had a prespecified noninferiority margin of 1.20 for the hazard ratio (HR) for the primary end point (a composite of all-cause mortality, nonfatal myocardial infarction or stroke, adjudicated by an independent blinded committee). This trial is registered with ClinicalTrials.gov, number NCT00773513.
RESULTS
In total, 2818 patients underwent randomization, received methoxy polyethylene glycol-epoetin beta or a reference agent, and were followed for a median of 3.4 years (maximum, 8.4 years). In the modified intention-to-treat analysis, a primary end point event occurred in 640 (45.4%) patients in the methoxy polyethylene glycol-epoetin beta arm, and 644 (45.7%) in the reference arm (HR 1.03; 95% confidence interval [95% CI], 0.93 to 1.15, P =0.004 for noninferiority). All-cause mortality was not different between treatment groups (HR 1.06; 95% CI, 0.94 to 1.19). Results in patient subgroups on dialysis or treated in the correction or maintenance settings were comparable to the primary analysis.
CONCLUSIONS
In patients with anemia of CKD, once-monthly methoxy polyethylene glycol-epoetin beta was noninferior to conventional, shorter-acting erythropoiesis-stimulating agents with respect to rates of major adverse cardiovascular events or all-cause mortality.",2019,"All-cause mortality was not different between treatment groups (HR 1.06; 95% CI, 0.94 to 1.19).","['patients with anemia of CKD', '2818 patients underwent randomization, received', 'Anemia of CKD']","['methoxy polyethylene glycol-epoetin beta with those of the shorter-acting agents epoetin alfa/beta and darbepoetin alfa', 'methoxy polyethylene glycol-epoetin beta or reference erythropoiesis-stimulating agents, stratified by maintenance or correction treatment status and C-reactive protein level', 'methoxy polyethylene glycol-epoetin beta or a reference agent', 'Methoxy Polyethylene Glycol-Epoetin Beta and Other Erythropoiesis-Stimulating Agents']","['hazard ratio (HR', 'All-cause mortality', 'mortality, nonfatal myocardial infarction or stroke', 'Cardiovascular Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1328071', 'cui_str': 'Methoxy polyethylene glycol-epoetin beta'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2818.0,0.313869,"All-cause mortality was not different between treatment groups (HR 1.06; 95% CI, 0.94 to 1.19).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Locatelli', 'Affiliation': 'Retired from Alessandro Manzoni Hospital, ASST Lecco, Lecco, Italy; f.locatelli@asst-lecco.it.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Hannedouche', 'Affiliation': 'School of Medicine, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Morgan', 'Affiliation': 'Biostatistics, F. Hoffmann-La Roche Ltd., Basel, Switzerland.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Oguey', 'Affiliation': 'Clinical Science, F. Hoffmann-La Roche Ltd., Basel, Switzerland; and.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'White', 'Affiliation': 'Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.01380219']
905,32440004,Arm-pull thrust in human swimming and the effect of post-activation potentiation.,"The aim of this study was to analyse the front-crawl arm-pull kinetics and kinematics, comparing it before and after post-activation potentiation (PAP), and the associations between variables describing of the arm-pull kinetics. Twelve male competitive swimmers were randomly assigned to perform two different warm-ups in a crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition). PAP consisted of 2 × 5 arm-pulls with resistance bands by both upper-limbs. Eight minutes later, participants underwent a 25 m all-out trial in front-crawl arm-pull. Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation) were collected by an in-house customised system composed of differential pressure sensors, speedo-meter and underwater camera. There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74). There were non-significant and small effects of PAP on speed (P = 0.307, d = 0.18) and speed fluctuation (P = 0.498, d = 0.04). Correlation coefficients among kinetic variables were significant with large associations (0.51 < R < 0.90, 0.001 < P < 0.088). In conclusion, warm-ups including PAP conditioning sets elicit a large improvement in the thrust, but with small improvement in performance. Variables used to characterise thrust are strongly correlated and hence can be used interchangeably.",2020,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).",['Twelve male competitive swimmers'],['crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition'],"['Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation', 'arm-pull kinetics', 'speed fluctuation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]",12.0,0.0288481,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).","[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore. tiago.barbosa@nie.edu.sg.'}, {'ForeName': 'Jia Wen', 'Initials': 'JW', 'LastName': 'Yam', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Lum', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Govindasamy', 'Initials': 'G', 'LastName': 'Balasekaran', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports, Health and Human Development - CIDESD, Vila Real, Portugal.'}]",Scientific reports,['10.1038/s41598-020-65494-z']
906,31468553,A Positive Youth Development Approach to Improving Mental Health Outcomes for Maltreated Children in Foster Care: Replication and Extension of an RCT of the Fostering Healthy Futures Program.,"Preventing the negative impact of maltreatment on children's mental health requires interventions to be contextually sensitive, grounded in theory and research, and effective in reaching and retaining children and families. This study replicates and extends previous findings of the Fostering Healthy Futures (FHF) program, a 30-week mentoring and skills group intervention for preadolescent maltreated children in foster care. Participants included 426 children recently placed in out-of-home care who were randomized to intervention or control conditions. Outcomes measured 6-10 months postintervention included a multi-informant (child, caregiver, teacher) index of mental health problems as well as measures of posttraumatic stress symptoms, dissociative symptoms, quality of life, and use of mental health services and psychotropic medications. There were high rates of program initiation, retention, and engagement; 95% of those randomized to FHF started the program, 92% completed it, and over 85% of the mentoring visits and skills groups were attended. The FHF program demonstrated significant impact in reducing mental health symptomatology, especially trauma symptoms, and mental health service utilization. These program effects were consistent across almost all subgroups, suggesting that FHF confers benefit for diverse children. Results indicate that positive youth development programming is highly acceptable to children and families and that it can positively impact trauma and its sequelae.",2019,"The FHF program demonstrated significant impact in reducing mental health symptomatology, especially trauma symptoms, and mental health service utilization.","['Maltreated Children in Foster Care', 'Participants included 426 children recently placed in out-of-home care who were randomized to', ""children's mental health"", 'preadolescent maltreated children in foster care']","['FHF', 'intervention or control conditions', 'Fostering Healthy Futures (FHF) program, a 30-week mentoring and skills group intervention']","['multi-informant (child, caregiver, teacher) index of mental health problems as well as measures of posttraumatic stress symptoms, dissociative symptoms, quality of life, and use of mental health services and psychotropic medications', 'Mental Health Outcomes', 'mental health symptomatology, especially trauma symptoms, and mental health service utilization']","[{'cui': 'C0580719', 'cui_str': 'Child in foster care (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0042153', 'cui_str': 'use'}]",426.0,0.0520039,"The FHF program demonstrated significant impact in reducing mental health symptomatology, especially trauma symptoms, and mental health service utilization.","[{'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Taussig', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Lindsey M', 'Initials': 'LM', 'LastName': 'Weiler', 'Affiliation': 'University of Minnesota - Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Edward F', 'Initials': 'EF', 'LastName': 'Garrido', 'Affiliation': 'University of Denver, Denver, CO, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Rhodes', 'Affiliation': 'Colorado Department of Education, Denver, CO, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Boat', 'Affiliation': 'The Improve Group, St Paul, MN, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Fadell', 'Affiliation': ""Children's Hospital Colorado, Aurora, CO, USA.""}]",American journal of community psychology,['10.1002/ajcp.12385']
907,31467422,Structured exercise alters the gut microbiota in humans with overweight and obesity-A randomized controlled trial.,"OBJECTIVES
Studies suggest that exercise affects the composition and function of the human gut microbiota, yet this has not been investigated in a randomized controlled trial. The primary aim of this study was to assess if exercise alters the diversity, composition and functional potential of the gut microbiota in free-living humans. A secondary aim was to test whether alpha diversity was associated with phenotypical outcomes.
METHODS
Eighty eight participants with overweight or obesity completed a 6-month randomized controlled trial with 4 arms; habitual living (CON), active commuting by bike (BIKE) and leisure-time exercise of moderate (MOD) or vigorous intensity (VIG). Faecal samples for 16 s rRNA gene amplicon sequencing were collected prior to randomization and again after 3 and 6 months, with simultaneous registration of phenotypical outcomes and diet.
RESULTS
Shannon's diversity index increased by 5% in VIG (CI95 1-9%, P = 0.012) at 3 months compared with CON. No associations were observed between alpha diversity and phenotypical outcomes. Beta diversity changed in all exercise groups compared with CON, particularly the participants in VIG showed decreased heterogeneity. No genera changed significantly. The inferred functional potential of the microbiota in the exercise groups was increased, primarily at 3 months and in MOD.
CONCLUSION
Structured exercise induced subtle changes to the human gut microbiota. Cardiorespiratory fitness and fat mass were not associated with alpha diversity.",2020,"Shannon's diversity index increased by 5% in VIG (CI95 1-9%, P = 0.012) at 3 months compared with CON.","['eight participants with overweight or obesity', 'humans with overweight and obesity', 'free-living humans', 'Eighty']","['habitual living (CON), active commuting by bike (BIKE) and leisure-time exercise of moderate (MOD) or vigorous intensity (VIG', 'Structured exercise']","['Beta diversity', ""Shannon's diversity index"", 'Cardiorespiratory fitness and fat mass']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",88.0,0.0839293,"Shannon's diversity index increased by 5% in VIG (CI95 1-9%, P = 0.012) at 3 months compared with CON.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Kern', 'Affiliation': 'The Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. kern@sund.ku.dk.'}, {'ForeName': 'Martin Bæk', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tue Haldor', 'Initials': 'TH', 'LastName': 'Hansen', 'Affiliation': 'The Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jonas Salling', 'Initials': 'JS', 'LastName': 'Quist', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Gram', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Claus Thorn', 'Initials': 'CT', 'LastName': 'Ekstrøm', 'Affiliation': 'Department of Public Health, Section of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'The Novo Nordisk Foundation Center for Basic Metabolic Research, Section of Metabolic Genetics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Stallknecht', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",International journal of obesity (2005),['10.1038/s41366-019-0440-y']
908,30869969,In-session emotional expression predicts symptomatic and panic-specific reflective functioning improvements in panic-focused psychodynamic psychotherapy.,"In panic-focused psychodynamic psychotherapy (PFPP), exploration and interpretation of avoided and conflicted emotions and fantasies surrounding anxiety are thought to promote panic-specific reflective functioning (PSRF), which drives panic disorder improvements. Patient emotional expression within a session may be a marker of engaged processing and experiencing of affectively charged material. Degree of in-session expressed emotion, indicating both verbal and nonverbal emotions, was examined across three early therapy sessions for prediction of subsequent outcomes. We further investigated whether personality disorder traits, theorized to relate to constricted (obsessive-compulsive) or heightened (borderline) emotions, moderated this relationship. Emotional expression in Sessions 2, 5, and 10 of a 24-session PFPP protocol was assessed by blinded observers in 44 patients randomized to PFPP in a two-site randomized controlled trial of psychotherapies for panic disorder. Robust regressions were conducted to examine the relationship between average emotional expression across the measured sessions and symptom and PSRF changes subsequent to the sampled sessions, as well as moderation by personality disorder criteria, controlling for early outcomes. Higher levels of emotional expression across the early sessions predicted greater subsequent symptom and PSRF improvement. Elevations in expression of grief/sadness drove the symptomatic finding. Patients meeting more borderline criteria experienced a smaller and potentially negative relationship between emotional expression and symptom improvement. Emotional expression in PFPP may be an indicator of positive therapy process for patients without comorbid borderline personality traits, predicting prospective improvements in both a key mediator (PSRF) and symptoms. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Emotional expression in Sessions 2, 5, and 10 of a 24-session PFPP protocol was assessed by blinded observers in 44 patients randomized to PFPP in a two-site randomized controlled trial of psychotherapies for panic disorder.","['patients without comorbid borderline personality traits', '44 patients randomized to', 'for panic disorder']","['psychotherapies', 'psychodynamic psychotherapy (PFPP', 'PFPP']","['verbal and nonverbal emotions', 'emotional expression and symptom improvement', 'Emotional expression', 'Higher levels of emotional expression', 'subsequent symptom and PSRF improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",44.0,0.0393514,"Emotional expression in Sessions 2, 5, and 10 of a 24-session PFPP protocol was assessed by blinded observers in 44 patients randomized to PFPP in a two-site randomized controlled trial of psychotherapies for panic disorder.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Zeeshan M', 'Initials': 'ZM', 'LastName': 'Huque', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jacques P', 'Initials': 'JP', 'LastName': 'Barber', 'Affiliation': 'Gordon F. Derner School of Psychology.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Milrod', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Dianne L', 'Initials': 'DL', 'LastName': 'Chambless', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000215']
909,10918098,"Prochlorperazine versus promethazine for uncomplicated nausea and vomiting in the emergency department: a randomized, double-blind clinical trial.","STUDY OBJECTIVE
Nausea and vomiting related to gastritis or gastroenteritis are common complaints in the emergency department. The most effective antiemetic agent is yet undetermined. This study was conducted to compare the efficacy of prochlorperazine versus promethazine for uncomplicated nausea and vomiting in the ED.
METHODS
The study was a randomized, double-blind comparison of prochlorperazine (Compazine) and promethazine (Phenergan) for acute ED treatment of gastritis or gastroenteritis. We studied patients 18 years or older with presumed uncomplicated gastritis or gastroenteritis who presented to 2 academic EDs. Patients were randomly assigned to receive either prochlorperazine, 10 mg intravenously, or promethazine, 25 mg intravenously. Visual analog scale readings of patient comfort were obtained at baseline and at 30- and 60-minute intervals. The primary endpoint was degree of relief at 30 and 60 minutes. Secondary endpoints were time to complete relief, need for further antiemetic medication (treatment failures), and side effects. Statistical analysis was performed using the Mann-Whitney U test for nonparametric analysis and repeated-measures analysis of variance (ANOVA).
RESULTS
Eighty-four patients were enrolled in the study; 42 received prochlorperazine and 42 received promethazine. There were no differences in demographics in the 2 groups. At baseline (time 0), there was no difference in symptoms (P =.23). At 30 and 60 minutes after receiving medication, prochlorperazine worked significantly better than promethazine (P =.004 and P <.001 using nonparametric analysis). Using repeated-measures ANOVA, there was a significant difference in symptoms over time for both groups (P <.001) and a significant difference in prochlorperazine versus promethazine (P =.002). Time to complete relief was significantly shorter with prochlorperazine (P =.021). There were significantly fewer treatment failures with prochlorperazine (P =.03, 9.5% versus 31%; difference 21%, 95% confidence interval 5 to 38). There was no difference in incidence of extrapyramidal effects. Prochlorperazine caused significantly fewer complaints of sleepiness (P =.002, 38% versus 71%; difference 33%, 95% confidence interval 13 to 53; P =.002).
CONCLUSION
Prochlorperazine works significantly better than promethazine for relieving symptoms of nausea and vomiting more quickly and completely in ED patients with uncomplicated nausea and vomiting.",2000,"Prochlorperazine caused significantly fewer complaints of sleepiness (P =.002, 38% versus 71%; difference 33%, 95% confidence interval 13 to 53; P =.002).
","['patients 18 years or older with presumed uncomplicated gastritis or gastroenteritis who presented to 2 academic EDs', 'acute ED treatment of gastritis or gastroenteritis', 'Eighty-four patients were enrolled in the study; 42 received']","['prochlorperazine (Compazine) and promethazine (Phenergan', 'Prochlorperazine', 'prochlorperazine', 'promethazine']","['nausea and vomiting', 'complaints of sleepiness', 'Visual analog scale readings of patient comfort', 'time to complete relief, need for further antiemetic medication (treatment failures), and side effects', 'Time to complete relief', 'degree of relief', 'uncomplicated nausea and vomiting', 'incidence of extrapyramidal effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017152', 'cui_str': 'Gastritis'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319623', 'cui_str': '84 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0591971', 'cui_str': 'Phenergan'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4277744', 'cui_str': 'Patient Comfort'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C0162643'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",84.0,0.582272,"Prochlorperazine caused significantly fewer complaints of sleepiness (P =.002, 38% versus 71%; difference 33%, 95% confidence interval 13 to 53; P =.002).
","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Ernst', 'Affiliation': 'Division of Emergency Medicine, Department of Medicine, University of California-Davis, Sacramento, CA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Weiss', 'Affiliation': 'Division of Emergency Medicine, Department of Medicine, University of California-Davis, Sacramento, CA.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Takakuwa', 'Affiliation': 'Division of Emergency Medicine, Department of Medicine, University of California-Davis, Sacramento, CA.'}, {'ForeName': 'Deborah B', 'Initials': 'DB', 'LastName': 'Diercks', 'Affiliation': 'Division of Emergency Medicine, Department of Medicine, University of California-Davis, Sacramento, CA.'}]",Annals of emergency medicine,['10.1067/mem.2000.108652']
910,31464753,Effects of Adding a Neurodynamic Mobilization to Motor Control Training in Patients With Lumbar Radiculopathy Due to Disc Herniation: A Randomized Clinical Trial.,"OBJECTIVE
The aim of the study was to investigate the effects of the inclusion of neural mobilization into a motor control exercise program on pain, related disability, neuropathic symptoms, straight leg raise, and pressure pain threshold in lumbar radiculopathy.
DESIGN
This is a randomized clinical trial.
METHODS
Individuals with low back pain, with confirmed disc herniation, and lumbar radiculopathy were randomly assigned to receive eight sessions of either neurodynamic mobilization plus motor control exercises (n = 16) or motor control exercises alone (n = 16). Outcomes included pain, disability, neuropathic symptoms, straight leg raise, and pressure pain threshold at baseline, after four visits, after eight visits, and after 2 mos.
RESULTS
There were no between-groups differences for pain, related disability, or pressure pain threshold at any follow-up period because both groups get similar and large improvements. Patients assigned to the neurodynamic program group experienced better improvements in neuropathic symptoms and the straight leg raise compared with the motor control exercise group (P < 0.01).
CONCLUSIONS
The addition of neurodynamic mobilization to a motor control exercise program leads to reductions in neuropathic symptoms and mechanical sensitivity (straight leg raise) but did not result in greater changes of pain, related disability, or pressure pain threshold over motor control exercises program alone in subjects with lumbar radiculopathy. Future trials are needed to further confirm these findings because between-groups differences did not reach clinically relevance.",2020,"Patients assigned to the neurodynamic program group experienced better improvements in neuropathic symptoms and the SLR compared to the motor control exercise group (P<0.01).
","['Individuals with LBP, with confirmed disc herniation, and lumbar radiculopathy', 'Patients with Lumbar Radiculopathy due to Disc Herniation', 'subjects with lumbar radiculopathy']","['neurodynamic mobilization plus motor control exercises (n=16) or motor control exercises alone', 'motor control exercise program', 'Neurodynamic Mobilization to Motor Control Training', 'neurodynamic program', 'neural mobilization into a motor control exercise program']","['neuropathic symptoms', 'pain, disability, neuropathic symptoms, SLR, and PPT at baseline, after 4 visits, after 8 visits, and after 2-months', 'pain, related-disability, neuropathic symptoms, straight leg raise (SLR), and pressure pain threshold (PPT', 'neuropathic symptoms and mechanical sensitivity (SLR', 'pain, related-disability, or PPT']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",,0.0926261,"Patients assigned to the neurodynamic program group experienced better improvements in neuropathic symptoms and the SLR compared to the motor control exercise group (P<0.01).
","[{'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'From the Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain (GP-M); Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain (GP-M); Clínica Fisiofit, Madrid, Spain (IC-C); Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain (CF-d-l-P, JLA-B, RO-S); Cátedra de Investigación y Docencia en Fisioterapia: Terapia Manual, Punción Seca y Ejercicio Terapeútico, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain (CF-d-l-P, JLA-B, RO-S); Physical Therapist, Rehabilitation Services, Concord Hospital, Concord, New Hampshire (JAC); Faculty, Manual Therapy Fellowship Program, Regis University, Denver, Colorado (JAC); Department of Physical Therapy, Franklin Pierce University, Manchester, New Hampshire (JAC); and Fysio-Experts, Hazerswoude-Rijndijk, the Netherlands (MT-d-G).'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cancela-Cilleruelo', 'Affiliation': ''}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': ''}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': ''}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': ''}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Thoomes-de-Graaf', 'Affiliation': ''}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ortega-Santiago', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001295']
911,32030723,A feasibility study of microwave therapy for precancerous actinic keratosis.,"BACKGROUND
Actinic keratosis (AK) is a common premalignant skin lesion that can progress to cutaneous squamous cell carcinoma (cSCC). Microwave therapy is an established cancer treatment and has been used for plantar viral warts.
OBJECTIVES
To evaluate the efficacy and feasibility of microwave as a treatment for AK.
METHODS
Stage I was a dose-setting study, in which seven participants had the dielectric properties of 12 thick and 22 thin AKs assessed for optimization of the microwave dose used for treatment in Stage II. Stage II was a randomized, internally controlled trial evaluating 179 AKs in 11 patients (93 treated, 86 untreated controls) on the scalp/forehead or dorsal hand. Participants received one treatment initially and a repeat treatment to unresolved AKs at week 4. The response was assessed at six visits over 4 months. The primary outcome was partial or complete resolution of the treated AKs.
RESULTS
A significantly higher proportion of treated AK areas responded than untreated (90% vs. 15%; P < 0·001). Thin AKs were more responsive than thick AKs. The site did not affect efficacy. Pain was severe, but brief (80% reported pain lasting 'a few seconds only'). Adverse effects were minimal (erythema, n = 6; flaking, n = 3; itch, n = 3). All participants who would chose microwave therapy over their current treatment cited the shorter discomfort period.
CONCLUSIONS
Microwave therapy is a portable, safe and effective treatment for AK. An easy-to-deliver, acceptable therapy for AK is attractive as a prevention strategy. While these results are promising, a larger randomized controlled trial is needed against an effective comparator to confirm clinical efficacy and patient acceptability. What is already known about this topic? Actinic keratoses (AKs) are common precancerous skin lesions. Successful treatment of AK can prevent cutaneous squamous cell carcinoma (cSCC). Most topical therapies for AK require repeated application over weeks and drive local skin inflammation, leading to poor compliance. An easy-to-deliver and effective treatment for AK, suitable for use in primary care, could reduce cSCC. What does this study add? Microwave therapy is a feasible, effective treatment for AK. Ninety per cent of treated AKs showed full or partial resolution at 120 days post-treatment. Microwave therapy was painful, but the pain was short-lived (seconds) and this short discomfort period was cited as the main reason that microwave was preferred to their current treatment.",2020,"Adverse effects were minimal (redness n=6, flaking n=3, itching n=3).","['11 patients (93 treated, 86 untreated controls) on the scalp/forehead or dorsal hand', 'Stage 1 was a dose-setting study, where seven participants had the dielectric properties of 12 thick and 22 thin AK assessed for optimisation of the microwave dose used for treatment in Stage 2', 'cutaneous squamous cell carcinoma (cSCC', 'Actinic keratosis (AK', 'precancerous actinic keratoses']",['microwave therapy'],"['Pain', 'partial or complete resolution of the treated AK', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0016540', 'cui_str': 'Forehead'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0026051', 'cui_str': 'Microwaves'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0553723', 'cui_str': 'Squamous cell carcinoma of skin (disorder)'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}]","[{'cui': 'C0438673', 'cui_str': 'Microwave diathermy (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",179.0,0.0432819,"Adverse effects were minimal (redness n=6, flaking n=3, itching n=3).","[{'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Jackson', 'Affiliation': 'Department of Dermatology, NHS Tayside, Ninewells Hospital, Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'F J', 'Initials': 'FJ', 'LastName': 'Hogarth', 'Affiliation': 'Tayside Clinical Trials Unit, University of Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sutherland', 'Affiliation': 'Clinical Research Centre, NHS Tayside, Ninewells Hospital, Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Holmes', 'Affiliation': 'Dundee Epidemiology and Biostatistics Unit, Population Health and Genomics, School of Medicine, University of Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'Dundee Epidemiology and Biostatistics Unit, Population Health and Genomics, School of Medicine, University of Dundee, DD1 9SY, Scotland, UK.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Proby', 'Affiliation': 'Department of Dermatology, NHS Tayside, Ninewells Hospital, Dundee, DD1 9SY, Scotland, UK.'}]",The British journal of dermatology,['10.1111/bjd.18935']
912,31464757,Preliminary Study of the Effect of Training With a Gaming Balance Board on Balance Control in Children With Cerebral Palsy: A Randomized Controlled Trial.,"OBJECTIVE
A new protocol based on the use of a gaming balance board for children with cerebral palsy was tested.
DESIGN
A total of 56 children with cerebral palsy were enrolled and randomly divided into two groups: experimental and control. The children in experimental group underwent 12 wks of rehabilitation using their foot to play personal computer games with the proposed balance board, whereas those in the control group played personal computer games with a computer mouse in the standing position. Balance control was assessed before and after the intervention using the Zebris FDM System for measuring the center of pressure. The Pediatric Balance Scale and 2-min walk test were used for evaluating functional balance.
RESULTS
In the analysis of covariance, the proposed new balance board used for the personal computer games decreased the postural sway (sway path, F = 6.95, P = 0.011; sway area, F = 11.79, P = 0.001) and improved the performance of the functional balance tests.
CONCLUSIONS
This study demonstrated the possibility that this new gaming balance board can be used for balance control in children with cerebral palsy.",2020,Balance control was assessed before and after the intervention using the Zebris FDM System for measuring the center of pressure.,"['56 children with cerebral palsy', 'children with cerebral palsy']","['rehabilitation using their foot to play personal computer games with the proposed balance board, whereas those in the control group played personal computer games with a computer mouse in the standing position', 'training with a gaming balance board']","['postural sway', 'Balance control', 'performance of the functional balance tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0162419', 'cui_str': 'Personal Computers'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721267', 'cui_str': 'Balance board'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position (finding)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",56.0,0.0171743,Balance control was assessed before and after the intervention using the Zebris FDM System for measuring the center of pressure.,"[{'ForeName': 'Hsieh-Chun', 'Initials': 'HC', 'LastName': 'Hsieh', 'Affiliation': 'From the Department of Special Education, National Tsing Hua University, Hsinchu City, Taiwan, Republic of China.'}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001300']
913,31442105,Effects of the Collaborative Assessment and Management of Suicidality (CAMS) Model: A Secondary Analysis of Moderation and Influencing Factors.,"In a randomized controlled trial, we found that suicidal patients who received Collaborative Assessment and Management of Suicidality (CAMS) reported greater improvements in suicidal ideation and mental health distress compared to participants who received treatment as usual (TAU). Here, we explored moderators and mediators of the effectiveness of CAMS. Compared to TAU, CAMS was more effective in reducing suicidal ideation when the working alliance, in particular its bond subcomponent, was low. In terms of reducing mental health distress, CAMS was superior to TAU only for participants who did not use illicit drugs and, more tentatively, only for patients without borderline personality traits. We suggest that CAMS may repair a difficult vantage point in terms of poor working alliance in patients with suicide ideation. To obtain superior benefits of CAMS upon more general mental health distress in patients with drug abuse or borderline traits, these problems may need to be more explicitly targeted in parallel.",2020,"Compared to TAU, CAMS was more effective in reducing suicidal ideation when the working alliance, in particular its bond subcomponent, was low.","['patients with suicide ideation', 'suicidal patients who received', 'patients with drug abuse or borderline traits']","['CAMS', 'Collaborative Assessment and Management of Suicidality (CAMS', 'TAU, CAMS', 'Collaborative Assessment and Management of Suicidality (CAMS) model']","['general mental health distress', 'suicidal ideation', 'suicidal ideation and mental health distress', 'mental health distress']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0013146', 'cui_str': 'Drug abuse (disorder)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",,0.109336,"Compared to TAU, CAMS was more effective in reducing suicidal ideation when the working alliance, in particular its bond subcomponent, was low.","[{'ForeName': 'Wenche', 'Initials': 'W', 'LastName': 'Ryberg', 'Affiliation': ''}, {'ForeName': 'Lien My', 'Initials': 'LM', 'LastName': 'Diep', 'Affiliation': ''}, {'ForeName': 'Nils Inge', 'Initials': 'NI', 'LastName': 'Landrø', 'Affiliation': ''}, {'ForeName': 'Roar', 'Initials': 'R', 'LastName': 'Fosse', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2019.1650143']
914,30879186,"Combined effects of very short ""all out"" efforts during sprint and resistance training on physical and physiological adaptations after 2 weeks of training.","PURPOSE
The aim of this study was to compare the combined effects of resistance and sprint training, with very short efforts (5 s), on aerobic and anaerobic performances, and cardiometabolic health-related parameters in young healthy adults.
METHODS
Thirty young physically active individuals were randomly allocated into four groups: resistance training (RTG), sprint interval training (SITG), concurrent training (CTG), and control (CONG). Participants trained 3 days/week for 2 weeks in the high-intensity interventions that consisted of 6-12 ""all out"" efforts of 5 s separated by 24 s of recovery, totalizing ~ 13 min per session, with 48-72 h of recovery between sessions. Body composition, vertical jump, lower body strength, aerobic and anaerobic performances, heart rate variability (HRV), and redox status were evaluated before and after training. Total work (TW), rating of perceived exertion (CR-10 RPE) and mean HR (HR mean ) were monitored during sessions. Incidental physical activity (PA), dietary intake and perceived stress were also controlled.
RESULTS
Maximum oxygen consumption (VO 2max ) significantly increased in SITG and CTG (P < 0.05). Lower body strength improved in RTG and CTG (P < 0.05), while countermovement jump (CMJ) was improved in RTG (P = 0.04) only. Redox status improved after all interventions (P < 0.05). No differences were found in TW, PA, dietary intake, and psychological stress between groups (P > 0.05).
CONCLUSIONS
RT and SIT protocols with very short ""all out"" efforts, either performed in isolation, or combined, demonstrated improvement in several physical fitness- and health-related parameters. However, CT was the most efficient exercise intervention with improvement observed in the majority of the parameters.",2019,"RESULTS
Maximum oxygen consumption (VO 2max ) significantly increased in SITG and CTG (P < 0.05).","['young healthy adults', 'Thirty young physically active individuals']","['CT', 'resistance training (RTG), sprint interval training (SITG), concurrent training (CTG), and control (CONG', 'resistance and sprint training']","['Body composition, vertical jump, lower body strength, aerobic and anaerobic performances, heart rate variability (HRV), and redox status', 'Lower body strength improved in RTG and CTG', 'Incidental physical activity (PA), dietary intake and perceived stress', 'Maximum oxygen consumption (VO 2max ', 'Redox status', 'TW, PA, dietary intake, and psychological stress', 'countermovement jump (CMJ', 'Total work (TW), rating of perceived exertion (CR-10 RPE) and mean HR (HR mean ']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0454374', 'cui_str': 'Sprint training (regime/therapy)'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1268088', 'cui_str': 'Lower body'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0030012', 'cui_str': 'Redox'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0444507', 'cui_str': 'Incidental (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",30.0,0.0135568,"RESULTS
Maximum oxygen consumption (VO 2max ) significantly increased in SITG and CTG (P < 0.05).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Benítez-Flores', 'Affiliation': 'Post-Graduation Program in Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Medeiros', 'Affiliation': 'Post-Graduation Program in Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Fabrício Azevedo', 'Initials': 'FA', 'LastName': 'Voltarelli', 'Affiliation': 'Post-graduation Program in Health Sciences, Faculty of Medicine, Federal University of Mato Grosso, Cuiabá, Brazil.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Department of Physical Education and Sports, Faculty of Sport Sciences and Physical Education, University of A Coruna, A Coruña, Spain.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'Sport and Exercise Science, James Cook University, Townsville, Australia.'}, {'ForeName': 'Herbert G', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Post-Graduation Program in Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Rosa', 'Affiliation': 'Post-Graduation Program in Physical Education, Catholic University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Boullosa', 'Affiliation': 'Sport and Exercise Science, James Cook University, Townsville, Australia. daniel.boullosa@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-019-04125-6']
915,30895460,"Aqua cycling for immunological recovery after intensive, eccentric exercise.","PURPOSE
Alterations in immunological homeostasis induced by acute exercise have been frequently reported. In view of the growing amount of repetitive exercise stimuli in competitive sports, quick recovery plays a superior role. Therefore, we examined whether aqua cycling affects cellular immunological recovery.
METHODS
After performing 300 countermovement jumps with maximal effort male sport students (n = 20; 24.4 ± 2.2 years) were randomized into either an aqua cycling (AC) or a passive recovery (P) group. AC pedaled in chest-deep water without resistance, while P lay in a supine position. Each recovery protocols lasted 30 min. Blood samples were taken at Baseline, Post-exercise, Post-recovery and 1 h (h), 2 h, 4 h, 24 h, 48 h and 72 h after recovery. Outcomes comprised white blood cell (WBC) counts, lymphocyte (LYM) counts and LYM subsets (CD4/CD8 ratio). Additionally, cellular inflammation markers (neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR) and systemic immune-inflammation index (SII)) were calculated.
RESULTS
In both groups, WBC, NLR and SII were significantly increased compared to Baseline up to and including 4 h after recovery. Significant interaction effects were found for WBC (Post-recovery, 2 h and 4 h), NLR (Post-recovery), SII (Post-recovery) and CD4/CD8 ratio (2 h) with values of AC being higher than of P.
CONCLUSIONS
Interestingly, AC provoked a stronger but not prolonged immunological disturbance than P. NLR and SII may present simple, more integrative markers to screen exercise-induced alterations in immune homeostasis/recovery in athletes and clinical populations. More research is warranted to elucidate the clinical and practical relevance of these findings.",2019,"In both groups, WBC, NLR and SII were significantly increased compared to Baseline up to and including 4 h after recovery.",['300 countermovement jumps with maximal effort male sport students (n\u2009=\u200920; 24.4\u2009±\u20092.2\xa0years'],['aqua cycling (AC) or a passive recovery (P) group'],"['cellular inflammation markers (neutrophil/lymphocyte ratio (NLR), platelet/lymphocyte ratio (PLR) and systemic immune-inflammation index (SII', 'Post-recovery, 2\xa0h and 4\xa0h), NLR (Post-recovery), SII (Post-recovery) and CD4/CD8 ratio (2\xa0h) with values of AC', 'white blood cell (WBC) counts, lymphocyte (LYM) counts and LYM subsets (CD4/CD8 ratio', 'WBC, NLR and SII', 'WBC ']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0449199', 'cui_str': 'LYM (body structure)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}]",,0.0534732,"In both groups, WBC, NLR and SII were significantly increased compared to Baseline up to and including 4 h after recovery.","[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Joisten', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walzik', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schenk', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Bloch', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany. p.zimmer@dshs-koeln.de.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wahl', 'Affiliation': 'Department of Molecular and Cellular Sport Medicine, Institute of Cardiovascular Research and Sport Medicine, German Sport University Cologne, Am Sportpark Müngersdorf 6, 50933, Cologne, Germany.'}]",European journal of applied physiology,['10.1007/s00421-019-04127-4']
916,30923873,Investigating circadian clock gene expression in human tendon biopsies from acute exercise and immobilization studies.,"PURPOSE
The discovery of musculoskeletal tissues, including muscle, tendons, and cartilage, as peripheral circadian clocks strongly implicates their role in tissue-specific homeostasis. Age-related dampening and misalignment of the tendon circadian rhythm and its outputs may be responsible for the decline in tendon homeostasis. It is unknown which entrainment signals are responsible for the synchronization of the tendon clock to the light-dark cycle.
METHODS
We sought to examine any changes in the expression levels of core clock genes (BMAL1, CLOCK, PER2, CRY1, and NR1D1) in healthy human patellar tendon biopsies obtained from three different intervention studies: increased physical activity (leg kicks for 1 h) in young, reduced activity (2 weeks immobilization of one leg) in young, and in old tendons.
RESULTS
The expression level of clock genes in human tendon in vivo was very low and a high variation between individuals was found. We were thus unable to detect any differences in core clock gene expression neither after acute exercise nor immobilization.
CONCLUSIONS
We are unable to find evidence for an effect of exercise or immobilization on circadian clock gene expression in human tendon samples.",2019,"It is unknown which entrainment signals are responsible for the synchronization of the tendon clock to the light-dark cycle.
","['human tendon samples', 'healthy human patellar tendon biopsies', 'for 1\xa0h) in young, reduced activity (2\xa0weeks immobilization of one leg) in young, and in old tendons', 'human tendon biopsies from acute exercise and immobilization studies']",['exercise or immobilization'],"['expression levels of core clock genes (BMAL1, CLOCK, PER2, CRY1, and NR1D1', 'physical activity (leg kicks']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0586569', 'cui_str': 'Tendon sample (specimen)'}, {'cui': 'C0206332', 'cui_str': 'Ligamentum Patellae'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.0208022,"It is unknown which entrainment signals are responsible for the synchronization of the tendon clock to the light-dark cycle.
","[{'ForeName': 'Ching-Yan Chloé', 'Initials': 'CC', 'LastName': 'Yeung', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Building 8, Nielsine Nielsens Vej 11, 2400, Copenhagen NV, Denmark. chloe.yeung@gmail.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schjerling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Building 8, Nielsine Nielsens Vej 11, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Katja M', 'Initials': 'KM', 'LastName': 'Heinemeier', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Building 8, Nielsine Nielsens Vej 11, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Anders P', 'Initials': 'AP', 'LastName': 'Boesen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Building 8, Nielsine Nielsens Vej 11, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Dideriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Building 8, Nielsine Nielsens Vej 11, 2400, Copenhagen NV, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjær', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Bispebjerg Hospital, Building 8, Nielsine Nielsens Vej 11, 2400, Copenhagen NV, Denmark.'}]",European journal of applied physiology,['10.1007/s00421-019-04129-2']
917,31449758,"Higher baseline fat oxidation promotes gynoid fat mobilization in response to a 12-week exercise intervention in sedentary, obese black South African women.","This 12-week exercise intervention study assessed changes in cardiorespiratory fitness (CRF), energy expenditure (EE), and substrate utilisation at rest and during exercise in obese, black South African (SA) women and explored associations with changes in body composition. Black SA women (body mass index: 30-40 kg·m -2 , age: 20-35 years) were randomised into control (CTL; n = 15, maintaining usual activity) or exercise (EXE; n = 20; 12 weeks, 4 days·week -1 , 40-60 min·day -1 at >70% peak heart rate) groups. Pre- and post-intervention testing included peak oxygen consumption, resting and steady state (50% peak oxygen consumption) EE, respiratory exchange, and body composition (dual-energy X-ray absorptiometry). Dietary intake (4-day) and daily step-count (ActivPAL, activPAL3c; PAL Technologies Ltd, Glasgow, UK) was collected at pre-testing and at 4, 8, and 12 weeks. EXE increased peak oxygen consumption (24.9 ± 2.4 to 27.6 ± 3.4 mL·min -1 ·kg -1 ; p < 0.001) and steady state fat oxidation rates (7.5 ± 2.5 to 9.0 ± 2.7 mg·min -1 ·kg -1 fat-free soft tissue mass; p = 0.003) (same relative exercise intensity). CTL remained unchanged ( p > 0.05). EXE reduced proportional gynoid fat mass (percentage total fat mass, p = 0.002). Baseline resting carbohydrate oxidation rates ( p = 0.036) and steady state fat oxidation rates ( p = 0.021) explained 60.6% of the variability in Δgynoid fat mass ( p < 0.001) in EXE. This 12-week exercise intervention improved CRF and steady state fat oxidation rates. Greater reliance on fat oxidation at baseline promoted proportional reductions in gynoid, not visceral, fat mass in response to exercise training. Novelty Combined exercise training in obese black South African women increased cardiorespiratory fitness and rates of fat oxidation during steady state exercise. Exercise training reduced proportional gynoid, not visceral, fat, potentially representing an ethnic/sex-specific response. Baseline substrate utilisation (resting and steady state exercise (50% peak oxygen uptake)) predicted changes in gynoid fat mass.",2020,Baseline resting carbohydrate oxidation rates (p=0.036) and steady state fat oxidation rates (p=0.021) explained 60.6% of the variability in ∆gynoid,"['obese black South African women', 'Black SA women (BMI 30-40 kg.m-2, 20-35 y', 'obese, black South African (SA) women', 'sedentary, obese black South African women']","['•Combined exercise training', 'control (CTL, n=15, maintaining usual activity) or exercise (EXE', '•Exercise training', 'EXE']","['CTL', 'CRF and steady state fat oxidation rates', 'cardiorespiratory fitness(CRF), energy expenditure (EE) and substrate utilization', 'proportional gynoid, not visceral, fat, potentially representing an ethnic/gender-specific response', 'proportional gynoid fat mass', 'steady state fat oxidation rates', 'Baseline resting carbohydrate oxidation rates', 'Dietary intake (4d) and daily step-count (ActivPAL', 'fat oxidation', 'EXE increased VO2peak', ' VO2peak, resting and steady state (50% VO2peak) EE and respiratory exchange and body composition (dual-energy X-ray absorptiometry (DXA', '•Baseline substrate utilization (resting and steady state exercise', 'cardiorespiratory fitness and rates of fat oxidation']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0339985,Baseline resting carbohydrate oxidation rates (p=0.036) and steady state fat oxidation rates (p=0.021) explained 60.6% of the variability in ∆gynoid,"[{'ForeName': 'Louise D', 'Initials': 'LD', 'LastName': 'Clamp', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Newlands, Western Cape 7725, South Africa.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mendham', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Newlands, Western Cape 7725, South Africa.'}, {'ForeName': 'Jacolene', 'Initials': 'J', 'LastName': 'Kroff', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Newlands, Western Cape 7725, South Africa.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Goedecke', 'Affiliation': 'Division of Exercise Science and Sports Medicine, Department of Human Biology, Faculty of Health Sciences, University of Cape Town, Newlands, Western Cape 7725, South Africa.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0460']
918,30955089,Acute effects of different set configurations during a strength-oriented resistance training session on barbell velocity and the force-velocity relationship in resistance-trained males and females.,"PURPOSE
This study explored the acute effects of strength-oriented resistance training sessions performed using three different set configurations on barbell velocity and the force-velocity (F-v) relationship of upper-body muscles in men and women.
METHOD
Thirteen men (age: 23.8 ± 2.5 years; 6-repetition maximum [6RM] load: 73.4 ± 15.6 kg) and 13 women (age: 21.5 ± 1.4 years; 6RM load: 32.8 ± 5.2 kg) performed 24 repetitions with a 6RM load during the bench press exercise using traditional (TR: 6 sets of 4 repetitions with 3 min of rest between sets), cluster (CL: 6 sets of 4 repetitions with 15 s of intra-set rest every two repetitions and 2 min and 45 s of rest between sets) and inter-repetition rest (IRR: 1 set of 24 repetitions with 39 s of rest between repetitions) set configurations. The F-v relationship parameters [maximum force (F 0 ), maximum velocity (v 0 ) and maximum power (P max )] were determined before and after each training session.
RESULTS
The average training velocity did not differ between the three set configurations (p = 0.234), but the IRR set configuration generally provided higher velocities during the last repetition of each set. Significant decreases in F 0 (p = 0.001) and P max (p = 0.024) but not in v 0 (p = 0.669) were observed after the training sessions. Comparable velocity loss was observed for men and women (- 12.1% vs. - 11.3%; p = 0.699).
CONCLUSIONS
The administration of very short intra-set rest periods does not allow for the attainment of higher velocities than traditional set configurations during strength-oriented resistance training sessions conducted with the bench press exercise when the work-to-rest ratio is equated.",2019,Significant decreases in F 0 (p = 0.001) and P max (p = 0.024) but not in v 0 (p = 0.669) were observed after the training sessions.,"['men and women', 'Thirteen men (age: 23.8\u2009±\u20092.5\xa0years; 6-repetition maximum [6RM] load: 73.4\u2009±\u200915.6\xa0kg) and 13 women (age: 21.5\u2009±\u20091.4\xa0years; 6RM load: 32.8\u2009±\u20095.2\xa0kg) performed 24 repetitions with a', 'resistance-trained males and females']","['strength-oriented resistance training sessions', 'strength-oriented resistance training session', '6RM load during the bench press exercise using traditional (TR: 6 sets of 4 repetitions with 3\xa0min of rest between sets), cluster (CL: 6 sets of 4 repetitions with 15\xa0s of intra-set rest every two repetitions and 2\xa0min and 45\xa0s of rest between sets) and inter-repetition rest (IRR']","['velocity loss', 'average training velocity', 'F-v relationship parameters [maximum force (F 0 ), maximum velocity (v 0 ) and maximum power (P max ']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0318873,Significant decreases in F 0 (p = 0.001) and P max (p = 0.024) but not in v 0 (p = 0.669) were observed after the training sessions.,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Torrejón', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain. alejandrotorrejon1@hotmail.com.'}, {'ForeName': 'Danica', 'Initials': 'D', 'LastName': 'Janicijevic', 'Affiliation': 'Faculty of Sport and Physical Education, University of Belgrade, The Research Centre, Belgrade, Serbia.'}, {'ForeName': 'Guy Gregory', 'Initials': 'GG', 'LastName': 'Haff', 'Affiliation': 'Centre for Exercise and Sports Science Research, Edith Cowan University, Joondalup, WA, Australia.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]",European journal of applied physiology,['10.1007/s00421-019-04131-8']
919,32441407,The influence of titanium base abutments on peri-implant soft tissue inflammatory parameters and marginal bone loss: A randomized clinical trial.,"BACKGROUND
Some techniques in implant dentistry have been suggested that may potentially alter peri-implant soft and hard tissue parameters.
PURPOSE
To evaluate the peri-implant soft tissue inflammatory parameters and crestal bone loss around titanium base abutments.
MATERIALS AND METHODS
Fifty two implants were placed in 21 patients and restored by single crowns. Subjects were randomly allocated into two groups: cement-retained abutment (n = 24) and titanium base (n = 28). Peri-implant probing depth, and mesial and distal marginal bone loss (MBL) were evaluated at implant loading (T1), 6 and 12 months (T2 and T3, respectively). Peri-implant bleeding-on-probing was evaluated at T2 and T3. Two-way repeated measures analysis of variance, Tukey test, Man Whitney, and Pearson correlation were performed for statistical analysis at P < .05.
RESULTS
The mean difference of peri-implant MBL from implant installation to 12 months in function was 1.15 ± 0.82 mm for the cement-retained group, and 1.23 ± 0.79 mm for the titanium base group. No statistically significant difference was found between the two groups for clinical and radiographic peri-implant evaluation.
CONCLUSIONS
Titanium base abutments present no negative effect on peri-implant soft tissue and MBL. When used to support single crowns, both approaches performed likewise regarding clinical and radiographic parameters.",2020,"No statistically significant difference was found between the two groups for clinical and radiographic peri-implant evaluation.
",['Fifty two implants were placed in 21 patients and restored by single crowns'],"['cement-retained abutment', 'titanium base abutments']","['marginal bone loss', 'Peri-implant probing depth, and mesial and distal marginal bone loss (MBL', 'Peri-implant bleeding-on-probing', 'variance, Tukey test, Man Whitney, and Pearson correlation']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0010384', 'cui_str': 'Crown'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",52.0,0.0639248,"No statistically significant difference was found between the two groups for clinical and radiographic peri-implant evaluation.
","[{'ForeName': 'Saulo', 'Initials': 'S', 'LastName': 'Pamato', 'Affiliation': 'Post-Graduate Program of Health Sciences, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}, {'ForeName': 'Heitor Marques', 'Initials': 'HM', 'LastName': 'Honório', 'Affiliation': 'Department of Pediatrics Dentistry, Orthodontics, and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru Campus, São Paulo, Brazil.'}, {'ForeName': 'Jorge Alexandre', 'Initials': 'JA', 'LastName': 'da Costa', 'Affiliation': 'Department of Prosthodontics, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}, {'ForeName': 'Jefferson Luiz', 'Initials': 'JL', 'LastName': 'Traebert', 'Affiliation': 'Post-Graduate Program of Health Sciences, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}, {'ForeName': 'Estevam Augusto', 'Initials': 'EA', 'LastName': 'Bonfante', 'Affiliation': 'Department of Prosthodontics and Periodontology, Bauru School of Dentistry, University of São Paulo, Bauru Campus, São Paulo, Brazil.'}, {'ForeName': 'Jefferson Ricardo', 'Initials': 'JR', 'LastName': 'Pereira', 'Affiliation': 'Post-Graduate Program of Health Sciences, University of Southern Santa Catarina, Tubarão, Santa Catarina, Brazil.'}]",Clinical implant dentistry and related research,['10.1111/cid.12900']
920,30949806,The time course of cross-education during short-term isometric strength training.,"PURPOSE
This study examined the time course of contralateral adaptations in maximal isometric strength (MVC), rate of force development (RFD), and rate of electromyographic (EMG) rise (RER) during 4 weeks of unilateral isometric strength training with the non-dominant elbow flexors.
METHODS
Twenty participants were allocated to strength training (n = 10, three female, two left hand dominant) or control (n = 10, three female, two left hand dominant) groups. Both groups completed testing at baseline and following each week of training to evaluate MVC strength, EMG amplitude, RFD and RER at early (RFD 50 , RER 50 ) and late (RFD 200 , RER 200 ) contraction phases for the dominant 'untrained' elbow flexors. The training group completed 11 unilateral isometric training sessions across 4 weeks.
RESULTS
The contralateral improvements for MVC strength (P < 0.01) and RFD 200 (P = 0.017) were evidenced after 2 weeks, whereas RFD 50 (P < 0.01) and RER 50 (P = 0.02) showed significant improvements after 3 weeks. Each of the dependent variables was significantly (P < 0.05) greater than baseline values at the end of the training intervention for the trained arm. No changes in any of the variables were observed for the control group (P > 0.10).
CONCLUSIONS
Unilateral isometric strength training for 2-3 weeks can produce substantial increases in isometric muscle strength and RFD for both the trained and untrained arms. These data have implications for rehabilitative exercise design and prescription.",2019,"The contralateral improvements for MVC strength (P < 0.01) and RFD 200 (P = 0.017) were evidenced after 2 weeks, whereas RFD 50 (P < 0.01) and RER 50 (P = 0.02) showed significant improvements after 3 weeks.","['n\u2009=\u200910, three female, two left hand dominant) or control (n\u2009=\u200910, three female, two left hand dominant) groups', 'Twenty participants']","['unilateral isometric training sessions across 4\xa0weeks', 'Unilateral isometric strength training', 'strength training', 'unilateral isometric strength training with the non-dominant elbow flexors']","['time course of cross-education', 'MVC strength', 'isometric muscle strength and RFD', 'RFD 200', ""MVC strength, EMG amplitude, RFD and RER at early (RFD 50 , RER 50 ) and late (RFD 200 , RER 200 ) contraction phases for the dominant 'untrained' elbow flexors"", 'maximal isometric strength (MVC), rate of force development (RFD), and rate of electromyographic (EMG) rise (RER', 'RFD 50']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}]","[{'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2927794', 'cui_str': 'RFD'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",20.0,0.0246058,"The contralateral improvements for MVC strength (P < 0.01) and RFD 200 (P = 0.017) were evidenced after 2 weeks, whereas RFD 50 (P < 0.01) and RER 50 (P = 0.02) showed significant improvements after 3 weeks.","[{'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Carr', 'Affiliation': 'Department of Health & Exercise Science, University of Oklahoma, 1401 Asp Ave, Room 104, Norman, OK, 73019, USA. jc.carr@ou.edu.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Department of Health, Exercise Science, & Recreation Management, University of Mississippi, University, MS, USA.'}, {'ForeName': 'Matt S', 'Initials': 'MS', 'LastName': 'Stock', 'Affiliation': 'School of Kinesiology and Physical Therapy, University of Central Florida, Orlando, FL, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health & Exercise Science, University of Oklahoma, 1401 Asp Ave, Room 104, Norman, OK, 73019, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'DeFreitas', 'Affiliation': 'Applied Neuromuscular Physiology Laboratory, Oklahoma State University, Stillwater, OK, USA.'}]",European journal of applied physiology,['10.1007/s00421-019-04130-9']
921,30953176,Impact of 8 weeks of repeated ischemic preconditioning on running performance.,"PURPOSE
To examine if repeated exposure to IPC treatment prior to training sessions improves oxygen uptake and 1-km running performance in highly trained middle-distance runners.
METHODS
Fourteen highly trained endurance runners (11 male/3 female, 19 ± 2 years, 64 ± 5 ml kg -1 min -1 ) completed a baseline maximal oxygen consumption ([Formula: see text]) test and 1-km running performance test before random assignment to an IPC or control group. Both groups were prescribed identical endurance training over an 8-week varsity season; however, the IPC group performed an IPC protocol (5 min ischemia, repeated 3 times, each separated by 5 min reperfusion) before every training session. After 8 weeks of training, participants completed a follow-up [Formula: see text] test and 1-km time trial.
RESULTS
[Formula: see text] did not increase from baseline in either group following the 8-week training bout (P = 0.2), and neither group varied more than the other ([Formula: see text] = IPC 0.6 ± 2 ml kg -1 min -1 ; control 1.5 ± 2 ml kg -1 min -1 , P = 0.6) or beyond typical measurement error. The IPC decreased 1-km time trial time by 0.4% (0.5 ± 2 s), while the control group decreased by 1% (1.5 ± 3 s), but neither change was significant compared to baseline (P = 0.2). There was also no difference in time trial improvement between IPC and control (P = 0.6). However, there was a trend towards IPC significantly improving running economy at low intensity (P = 0.057).
CONCLUSION
Our data suggest that over a normal 8-week season in a population of highly trained middle-distance runners there is no benefit of undergoing chronic, repeated IPC treatments before training for augmenting maximal aerobic power or 1-km performance time.",2019,"However, there was a trend towards IPC significantly improving running economy at low intensity (P = 0.057).
","['highly trained middle-distance runners', 'Fourteen highly trained endurance runners (11 male/3 female, 19\u2009±\u20092\xa0years, 64\u2009±\u20095']","['IPC protocol', 'identical endurance training', 'baseline maximal oxygen consumption ([Formula: see text]) test and 1-km running performance test before random assignment to an IPC or control group', 'IPC 0.6\u2009±\u20092\xa0ml\xa0kg -1 \xa0min -1 ; control 1.5\u2009±\u20092\xa0ml\xa0kg -1', 'ischemic preconditioning']","['IPC decreased 1-km time trial time', 'oxygen uptake and 1-km running performance', 'time trial improvement', 'running performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4068883', 'cui_str': 'Zero point six'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]",14.0,0.230065,"However, there was a trend towards IPC significantly improving running economy at low intensity (P = 0.057).
","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Slysz', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, ANNU Building, 50 Stone Rd East, Guelph, ON, N1G 2W1, Canada.'}, {'ForeName': 'Jamie F', 'Initials': 'JF', 'LastName': 'Burr', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, ANNU Building, 50 Stone Rd East, Guelph, ON, N1G 2W1, Canada. burrj@uoguelph.ca.'}]",European journal of applied physiology,['10.1007/s00421-019-04133-6']
922,32134208,"Efficacy of multidomain interventions to improve physical frailty, depression and cognition: data from cluster-randomized controlled trials.","BACKGROUND
Frailty is the pre-eminent exigency of aging. Although frailty-related impairments are preventable, and multidomain interventions appear more effective than unimodal ones, the optimal components remain uncertain.
METHODS
We devised multidomain interventions against physical and cognitive decline among prefrail/frail community-dwelling ≥65-year-olds and evaluated these in complementary cluster-randomized trials of efficacy and participant empowerment. The Efficacy Study compared ~3-monthly telephone consultations vs. 16, 2 h sessions/year comprising communally partaken physical and cognitive training plus nutrition and disease education; the Empowerment Study compared the standard Efficacy Study multidomain intervention (Sessions 1-10) vs. an enhanced version redesigned to empower and motivate individual participants. Changes from baseline in physical, functional, and cognitive performance were measured after 6 and 12 months in the Efficacy Study and after 6 months in the Empowerment Study, with post-intervention follow-up at 9 months. Primary outcomes are as follows: Cardiovascular Health Study frailty score; gait speed; handgrip strength; and Montreal Cognitive Assessment (MoCA). Secondary outcomes are as follows: instrumental activities of daily living; metabolic equivalent of task (MET); depressed mood (Geriatric Depression Scale-5 ≥2); and malnutrition (Mini-Nutritional Assessment short-form ≤11). Intervention effects were analyzed using a generalized linear mixed model.
RESULTS
Efficacy Study participants (n = 1082, 40 clusters) were 75.1 ± 6.3 years old, 68.7% women, and 64.7% prefrail/frail; analytic clusters: 19 intervention (410/549 completed) vs. 21 control (375/533 completed). Empowerment Study participants (n = 440, 14 clusters) were 75.9 ± 7.1 years old, 83.6% women, and 56.7% prefrail/frail; analytic clusters: seven intervention (209/230 completed) vs. seven control (189/210 completed). The standard and enhanced multidomain interventions both reduced frailty and significantly improved aspects of physical, functional, and cognitive performance, especially among ≥75-year-olds. Standard multidomain intervention decreased depression [odds ratio 0.56, 95% confidence interval (CI) 0.32, 0.99] and malnutrition (odds ratio 0.45, 95% CI 0.26, 0.78) by 12 months and improved concentration at Months 6 (0.23, 95% CI 0.04, 0.42) and 12 (0.46, 95% CI 0.22, 0.70). Participant empowerment augmented activity (4.67 MET/h, 95% CI 1.64, 7.69) and gait speed (0.06 m/s, 95% CI 0.00, 0.11) at 6 months, with sustained improvements in delayed recall (0.63, 95% CI 0.20, 1.06) and MoCA performance (1.29, 95% CI 0.54, 2.03), and less prevalent malnutrition (odds ratio 0.39, 95% CI 0.18, 0.84), 3 months after the intervention ceased.
CONCLUSIONS
Pragmatic multidomain intervention can diminish physical frailty, malnutrition, and depression and enhance cognitive performance among community-dwelling elders, especially ≥75-year-olds; this might supplement healthy aging policies, probably more effectively if participants are empowered.",2020,"Standard multidomain intervention decreased depression [odds ratio 0.56, 95% confidence interval (CI) 0.32, 0.99] and malnutrition (odds ratio 0.45, 95% CI 0.26, 0.78) by 12 months and improved concentration at Months 6 (0.23, 95% CI 0.04, 0.42) and 12 (0.46, 95% CI 0.22, 0.70).","['prefrail/frail community-dwelling ≥65-year-olds', 'Efficacy Study participants (n = 1082, 40 clusters) were 75.1 ± 6.3 years old, 68.7% women, and 64.7% prefrail/frail; analytic clusters: 19 intervention (410/549 completed) vs. 21 control (375/533 completed', 'Empowerment Study participants (n = 440, 14 clusters) were 75.9 ± 7.1 years old, 83.6% women, and 56.7% prefrail/frail; analytic clusters: seven intervention (209/230 completed) vs. seven control (189/210 completed', 'community-dwelling elders']","['multidomain interventions', 'multidomain intervention (Sessions 1-10) vs. an enhanced version redesigned to empower and motivate individual participants', '3-monthly telephone consultations vs. 16, 2 h sessions/year comprising communally partaken physical and cognitive training plus nutrition and disease education', 'Pragmatic multidomain intervention']","['Cardiovascular Health Study frailty score; gait speed; handgrip strength; and Montreal Cognitive Assessment (MoCA', 'gait speed', 'physical, functional, and cognitive performance', 'physical frailty, depression and cognition', 'prevalent malnutrition', 'malnutrition', 'instrumental activities of daily living; metabolic equivalent of task (MET); depressed mood (Geriatric Depression Scale-5 ≥2); and malnutrition (Mini-Nutritional Assessment short-form ≤11', 'MoCA performance', 'delayed recall', 'depression', 'physical frailty, malnutrition, and depression and enhance cognitive performance']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C3496286'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C2983100', 'cui_str': 'MET - metabolic equivalent of task'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.0954159,"Standard multidomain intervention decreased depression [odds ratio 0.56, 95% confidence interval (CI) 0.32, 0.99] and malnutrition (odds ratio 0.45, 95% CI 0.26, 0.78) by 12 months and improved concentration at Months 6 (0.23, 95% CI 0.04, 0.42) and 12 (0.46, 95% CI 0.22, 0.70).","[{'ForeName': 'Liang-Kung', 'Initials': 'LK', 'LastName': 'Chen', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'An-Chun', 'Initials': 'AC', 'LastName': 'Hwang', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ju', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Li-Ning', 'Initials': 'LN', 'LastName': 'Peng', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Hsien', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Neil', 'Affiliation': 'Full Universe Integrated Marketing, Taipei, Taiwan.'}, {'ForeName': 'Shu-Fang', 'Initials': 'SF', 'LastName': 'Shih', 'Affiliation': 'Department of Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shu-Ti', 'Initials': 'ST', 'LastName': 'Chiou', 'Affiliation': 'Institute of Public Health, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12534']
923,32441691,Wellness Coaching: An Intervention to Increase Healthy Behavior in Breast Cancer Survivors.,"BACKGROUND
Regular physical activity after breast cancer diagnosis improves survival rates and quality of life (QOL). However, breast cancer survivors rarely meet guidelines for recommended levels of physical activity. Wellness coaching interventions (WCIs) have improved exercise and health behaviors in other patient populations.
OBJECTIVES
This study assessed the feasibility and effectiveness of WCIs for increasing physical activity in breast cancer survivors; secondary measures included changes in dietary habits, weight, and QOL.
METHODS
20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment were recruited into a single-arm, 12-week WCI pilot feasibility study. The intervention was comprised of one in-person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations.
FINDINGS
Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL. Forty percent of participants achieved the 3% postintervention weight-loss goal, but this was not sustained at 30 weeks.",2020,"FINDINGS
Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","['Breast Cancer Survivors', 'breast cancer survivors', '20 obese or overweight breast cancer survivors who recently completed active breast cancer treatment']","['WCIs', 'Wellness coaching interventions (WCIs', 'person wellness coaching visit followed by four telephone calls over 12 weeks and 12 weekly emails containing wellness recommendations', 'Wellness Coaching']","['dietary habits, weight, and QOL', 'physical activity level, dietary habits', 'survival rates and quality of life (QOL']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.0242179,"FINDINGS
Significant improvements from pre- to postintervention were seen in physical activity level, dietary habits, and in some aspects of QOL.","[{'ForeName': 'Daniela L', 'Initials': 'DL', 'LastName': 'Stan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Cutshall', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Tammy F', 'Initials': 'TF', 'LastName': 'Adams', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Ghosh', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kaisa C', 'Initials': 'KC', 'LastName': 'Wieneke', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Esayas B', 'Initials': 'EB', 'LastName': 'Kebede', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Donelan Dunlap', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ruddy', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Hazelton', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Alissa M', 'Initials': 'AM', 'LastName': 'Butts', 'Affiliation': 'Medical College of Wisconsin.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Jenkins', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Ivana T', 'Initials': 'IT', 'LastName': 'Croghan', 'Affiliation': 'Mayo Clinic.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Bauer', 'Affiliation': 'Mayo Clinic.'}]",Clinical journal of oncology nursing,['10.1188/20.CJON.305-315']
924,31577664,Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.,"BACKGROUND
Breast reconstruction with the deep inferior epigastric perforator (DIEP) flap can be associated with complications such as fat necrosis. The authors' objective was to assess the safety and efficacy of fluorescent angiography with indocyanine green to reduce fat necrosis.
METHODS
The authors designed a parallel, randomized, controlled clinical trial for unilateral breast reconstruction. The poorly vascularized tissues of the DIEP flap were removed based on a clinical evaluation in group 1 and based on angiographic criteria in group 2. The authors recorded the flap dimensions, perfusion in terms of fluorescence intensity, complications, reoperations, and BREAST-Q questionnaire scores for both groups.
RESULTS
The study included a total of 51 patients. The flaps showed no size differences after the tissue was excised. The flaps of group 2 presented higher perfusion rates (p = 0.001). The incidence of fat necrosis was 59.3 percent in group 1 and 8.3 percent in group 2 (p = 0.001). Four cases of partial necrosis were recorded in group 1 (18.2 percent) compared with none in group 2 (0 percent) (p = 0.131). Four patients underwent reoperation in group 1 (14.8 percent) compared with none in group 2 (0 percent) (p = 0.113). The patients in group 2 reported higher scores in all domains of the BREAST-Q.
CONCLUSIONS
Fluorescent angiography with indocyanine green significantly reduced the incidence of fat necrosis without diminishing the flaps' dimensions. The perfusion rates were significantly higher and the patients reported significantly greater satisfaction and quality of life. Fluorescent angiography with indocyanine green may be considered a safe and effective tool to enhance the outcomes of breast reconstruction with the DIEP flap.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Therapeutic, I.",2020,The flaps of group 2 presented higher perfusion rates (p=.001).,['51 patients'],"['fluorescent angiography with indocyanine green (FA-ICG', 'DIEP flap and fluorescent angiography']","['perfusion rates', 'satisfaction and quality of life', 'incidence of fat necrosis', 'partial necrosis', 'flap dimensions, perfusion in terms of fluorescence intensity, complications, reoperations and BREAST-Q questionnaire scores', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0082274', 'cui_str': 'diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034380'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0015668', 'cui_str': 'Steatonecrosis'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",51.0,0.11374,The flaps of group 2 presented higher perfusion rates (p=.001).,"[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Varela', 'Affiliation': 'Madrid, Spain From the Division of Plastic and Reconstructive Surgery and the Department of Preventive Medicine & Biostatistics, FibHULP/Idipaz Hospital Universitario La Paz.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Casado-Sanchez', 'Affiliation': ''}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Zarbakhsh', 'Affiliation': ''}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diez', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Hernandez-Godoy', 'Affiliation': ''}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Landin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006393']
925,30239215,Psychometric Properties of Figure Rating Scales in Children: The Impact of Figure Ordering.,"This study examined psychometric properties of figure rating scales, particularly the effects of ascending silhouette ordering, in 153 children, 9 to 13 years old. Two versions of Collins's (1991) figural rating scale were presented: the original scale (figures arranged ascendingly) and a modified version (randomized figure ordering). Ratings of current and ideal figure were elicited and body dissatisfaction was calculated. All children were randomly assigned to one of two subgroups and completed both scale versions in a different sequence. There were no significant differences in figure selection and body dissatisfaction between the two figure orderings. Regarding the selection of the current figure, results showed that girls are more affected by the silhouette ordering than boys. Our results suggest that figure rating scales are both valid and reliable, whereby correlation coefficients reveal greater stability for ideal figure selections and body dissatisfaction ratings when using the scale with ascending figure ordering.",2020,There were no significant differences in figure selection and body dissatisfaction between the two figure orderings.,"['153 children, 9 to 13 years old', 'Children']",[],"['figure selection and body dissatisfaction', 'Psychometric Properties of Figure Rating Scales', ""Collins's (1991) figural rating scale""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0033920', 'cui_str': 'Psychometrics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0222045'}]",153.0,0.0180253,There were no significant differences in figure selection and body dissatisfaction between the two figure orderings.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Zitzmann', 'Affiliation': 'Department of Psychology, University of Potsdam, Potsdam, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Warschburger', 'Affiliation': 'Department of Psychology, University of Potsdam, Potsdam, Germany.'}]",Journal of personality assessment,['10.1080/00223891.2018.1505731']
926,29729848,Development and Validation of a 28-gene Hypoxia-related Prognostic Signature for Localized Prostate Cancer.,"BACKGROUND
Hypoxia is associated with a poor prognosis in prostate cancer. This work aimed to derive and validate a hypoxia-related mRNA signature for localized prostate cancer.
METHOD
Hypoxia genes were identified in vitro via RNA-sequencing and combined with in vivo gene co-expression analysis to generate a signature. The signature was independently validated in eleven prostate cancer cohorts and a bladder cancer phase III randomized trial of radiotherapy alone or with carbogen and nicotinamide (CON).
RESULTS
A 28-gene signature was derived. Patients with high signature scores had poorer biochemical recurrence free survivals in six of eight independent cohorts of prostatectomy-treated patients (Log rank test P < .05), with borderline significances achieved in the other two (P < .1). The signature also predicted biochemical recurrence in patients receiving post-prostatectomy radiotherapy (n = 130, P = .007) or definitive radiotherapy alone (n = 248, P = .035). Lastly, the signature predicted metastasis events in a pooled cohort (n = 631, P = .002). Prognostic significance remained after adjusting for clinic-pathological factors and commercially available prognostic signatures. The signature predicted benefit from hypoxia-modifying therapy in bladder cancer patients (intervention-by-signature interaction test P = .0026), where carbogen and nicotinamide was associated with improved survival only in hypoxic tumours.
CONCLUSION
A 28-gene hypoxia signature has strong and independent prognostic value for prostate cancer patients.",2018,"Patients with high signature scores had poorer biochemical recurrence free survivals in six of eight independent cohorts of prostatectomy-treated patients (Log rank test P < .05), with borderline significances achieved in the other two (P < .1).","['bladder cancer patients', 'Localized Prostate Cancer', 'prostate cancer patients', 'eleven prostate cancer cohorts and a bladder cancer phase III randomized trial of']","['radiotherapy alone or with carbogen and nicotinamide (CON', 'definitive radiotherapy alone']","['biochemical recurrence', 'biochemical recurrence free survivals', 'survival']","[{'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0054692', 'cui_str': 'carbogen'}, {'cui': 'C0028027', 'cui_str': 'nicotinamide'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",11.0,0.0318936,"Patients with high signature scores had poorer biochemical recurrence free survivals in six of eight independent cohorts of prostatectomy-treated patients (Log rank test P < .05), with borderline significances achieved in the other two (P < .1).","[{'ForeName': 'Lingjian', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Roberts', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Takhar', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Erho', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Becky A S', 'Initials': 'BAS', 'LastName': 'Bibby', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Niluja', 'Initials': 'N', 'LastName': 'Thiruthaneeswaran', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK; Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.'}, {'ForeName': 'Vinayak', 'Initials': 'V', 'LastName': 'Bhandari', 'Affiliation': 'Informatics & Biocomputing Program, Ontario Institute for Cancer Research, Toronto, Canada; Sydney Medical School, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Haider', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK; Weatherall Institute of Molecular Medicine, University of Oxford, Oxford OX3 9DS, UK.'}, {'ForeName': 'Amy M B', 'Initials': 'AMB', 'LastName': 'McCorry', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast BT9 7BL, Northern Ireland, UK.""}, {'ForeName': 'Darragh', 'Initials': 'D', 'LastName': 'McArt', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast BT9 7BL, Northern Ireland, UK.""}, {'ForeName': 'Suneil', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast BT9 7BL, Northern Ireland, UK.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alshalalfa', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Ross', 'Affiliation': 'James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Schaffer', 'Affiliation': 'Northwestern Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Den', 'Affiliation': 'Department of Radiation Oncology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jeffrey Karnes', 'Affiliation': 'Department of Urology, Mayo Clinic Rochester, MN, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Klein', 'Affiliation': 'Glickman Urological Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hoskin', 'Affiliation': 'Mount Vernon Cancer Centre, Rickmansworth Road, Northwood, Middlesex HA6 2RN, UK.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Freedland', 'Affiliation': 'Department of Surgery, Division of Urology, Center for Integrated Research on Cancer and Lifestyle, Samuel Oschin Comprehensive Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Alastair D', 'Initials': 'AD', 'LastName': 'Lamb', 'Affiliation': 'Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge CB2 0RE, UK; Nuffield Department of Surgical Sciences, University of Oxford, Old Road Campus Research Building, Headington, Oxford OX3 7DQ, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Old Road Campus Research Building, Headington, Oxford OX3 7DQ, UK.'}, {'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Buffa', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford OX3 7DQ, UK; Weatherall Institute of Molecular Medicine, University of Oxford, Oxford OX3 9DS, UK.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Bristow', 'Affiliation': 'Princess Margaret Cancer Centre, University Health Network, Toronto, Canada; Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Boutros', 'Affiliation': 'Informatics & Biocomputing Program, Ontario Institute for Cancer Research, Toronto, Canada; Department of Medical Biophysics, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Elai', 'Initials': 'E', 'LastName': 'Davicioni', 'Affiliation': 'GenomeDx Biosciences, Vancouver, BC, Canada.'}, {'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Choudhury', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK.'}, {'ForeName': 'Catharine M L', 'Initials': 'CML', 'LastName': 'West', 'Affiliation': 'Translational Radiobiology Group, Division of Cancer Sciences, University of Manchester, Manchester Academic Health Science Centre, Christie Hospital, Manchester M20 4BX, UK; NIHR Manchester Biomedical Research Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, UK. Electronic address: catharine.west@manchester.ac.uk.'}]",EBioMedicine,['10.1016/j.ebiom.2018.04.019']
927,32133778,"Bioavailability of Triprolidine as a Single Agent or in Combination With Pseudoephedrine: A Randomized, Open-Label Crossover Study in Healthy Volunteers.","Antihistamines have been in clinical use for more than 70 years to treat allergic and nonallergic symptoms including relief from cold and flu symptoms. Despite their widespread use, pharmacokinetic (PK) data are sparse for older, first-generation antihistamines. This phase 1 single-center open-label, randomized, single-dose, 3-way crossover trial evaluated the PK profiles of 2 doses of film-coated triprolidine caplets (2.5 and 5 mg) compared with a reference combination tablet (triprolidine 2.5 mg + pseudoephedrine 60 mg) in 24 healthy adults. Blood samples were collected predose and at specified intervals across a 24-hour period after administration, and triprolidine was quantified using liquid chromatography-tandem mass spectrometry. Maximum plasma concentration of triprolidine for the 2.5 mg and dose-normalized 5 mg single-agent tablets were comparable (8.4 versus 7.1 ng/mL, respectively) and higher for the combination tablet (9.5 ng/mL). PK parameters, including time to maximum plasma concentration (∼1.5 hours) and elimination half-life (∼4 hours), were comparable between the 3 treatment arms. The safety profile of this sedating antihistamine was as expected; however, adverse effects were reported in a markedly higher proportion of women than men. There were no significant sex differences in any of the measured PK parameters.",2020,There were no significant sex differences in any of the measured PK parameters.,"['Healthy Volunteers', '24 healthy adults']","['sedating antihistamine', 'Antihistamines', 'Pseudoephedrine', 'Triprolidine', 'reference combination tablet (triprolidine 2.5\xa0mg + pseudoephedrine', 'film-coated triprolidine caplets']","['time to maximum plasma concentration', 'adverse effects', 'Bioavailability', 'Maximum plasma concentration of triprolidine']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1955826', 'cui_str': 'Antihistamines, Sedating'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0041098', 'cui_str': 'Triprolidine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0041098', 'cui_str': 'Triprolidine'}]",24.0,0.110154,There were no significant sex differences in any of the measured PK parameters.,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Febbraro', 'Affiliation': 'PRA Health Sciences, Reading, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Shea', 'Affiliation': 'Reckitt Benckiser Health LLC, Parsippany, New Jersey, USA.'}, {'ForeName': 'Ana Santos', 'Initials': 'AS', 'LastName': 'Cravo', 'Affiliation': 'Reckitt Benckiser Healthcare Ltd, Slough, UK.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.777']
928,29538636,Risk of Suicidal Behavior With Use of Efavirenz: Results from the Strategic Timing of Antiretroviral Treatment Trial.,"Background
Randomized trials have shown increased risk of suicidality associated with efavirenz (EFV). The START (Strategic Timing of Antiretroviral Treatment) trial randomized treatment-naive human immunodeficiency virus (HIV)-positive adults with high CD4 cell counts to immediate vs deferred antiretroviral therapy (ART).
Methods
The initial ART regimen was selected prior to randomization (prespecified). We compared the incidence of suicidal and self-injurious behaviours (suicidal behavior) between the immediate vs deferred ART groups using proportional hazards models, separately for those with EFV and other prespecified regimens, by intention to treat, and after censoring participants in the deferred arm at ART initiation.
Results
Of 4684 participants, 271 (5.8%) had a prior psychiatric diagnosis. EFV was prespecified for 3515 participants (75%), less often in those with psychiatric diagnoses (40%) than without (77%). While the overall intention-to-treat comparison showed no difference in suicidal behavior between arms (hazard ratio [HR], 1.07, P = .81), subgroup analyses suggest that initiation of EFV, but not other ART, is associated with increased risk of suicidal behavior. When censoring follow-up at ART initiation in the deferred group, the immediate vs deferred HR among those who were prespecified EFV was 3.31 (P = .03) and 1.04 (P = .93) among those with other prespecified ART; (P = .07 for interaction). In the immediate group, the risk was higher among those with prior psychiatric diagnoses, regardless of prespecified treatment group.
Conclusions
Participants who used EFV in the immediate ART group had increased risk of suicidal behavior compared with ART-naive controls. Those with prior psychiatric diagnoses were at higher risk.",2018,"In the immediate group, the risk was higher among those with prior psychiatric diagnoses, regardless of prespecified treatment group.
","['4684 participants, 271 (5.8%) had a prior psychiatric diagnosis', 'naive human immunodeficiency virus (HIV)-positive adults with high CD4 cell counts to immediate vs deferred antiretroviral therapy (ART']","['efavirenz (EFV', 'Efavirenz']","['Risk of Suicidal Behavior', 'suicidal behavior', 'EFV', 'incidence of suicidal and self-injurious behaviours (suicidal behavior', 'risk of suicidal behavior']","[{'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0376338', 'cui_str': 'Diagnosis, Psychiatric'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0852567', 'cui_str': 'Suicidal and self-injurious behaviour'}]",4684.0,0.367085,"In the immediate group, the risk was higher among those with prior psychiatric diagnoses, regardless of prespecified treatment group.
","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Arenas-Pinto', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, United Kingdom.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Grund', 'Affiliation': 'School of Statistics, Minneapolis.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Martinez', 'Affiliation': 'Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Cummins', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fox', 'Affiliation': ""Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Klingman', 'Affiliation': 'Division of AIDS, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Dalibor', 'Initials': 'D', 'LastName': 'Sedlacek', 'Affiliation': 'University Hospital Plzen, Czech Republic.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': 'HIV i-Base, London, United Kingdom.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Flynn', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Chasanov', 'Affiliation': 'Cooper University Hospital, Camden, New Jersey.'}, {'ForeName': 'Eynat', 'Initials': 'E', 'LastName': 'Kedem', 'Affiliation': 'Clinical Immunology Unit, Rambam Health Care Center, Haifa, Israel.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Katlama', 'Affiliation': 'Hospitalier Pitié-Salpétrière, Paris, France.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sierra-Madero', 'Affiliation': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Tlalpan, México.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Afonso', 'Affiliation': 'Hospital de Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Brouwers', 'Affiliation': 'Division of AIDS, National Institute of Allergy & Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cooper', 'Affiliation': 'The Kirby Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy051']
929,31238784,Can WeChat group-based intervention reduce reperfusion time in patients with ST-segment myocardial infarction? A controlled before and after study.,"BACKGROUND
Pre-hospital identification of acute ST-elevation myocardial infarction and activation of the catheterization laboratory can reduce first medical contact to wire-crossing times. We conducted a study on providing 24-hour tele-electrocardiography services via the WeChat group application, aiming to reduce the time taken for diagnosis and treatment of ST-elevation myocardial infarction.
METHODS
A controlled before and after study was conducted on 140 ST-elevation myocardial infarction patients who were initially seen in non-percutaneous coronary intervention-capable hospital and transferred for primary percutaneous coronary intervention at our percutaneous coronary intervention centre from 1 February to 31 October 2018. The WeChat group had 70 patients with pre-hospital electrocardiography transmission via WeChat and the control group had 70 patients who did not transfer pre-hospital electrocardiography. The reperfusion time of the two groups was compared to evaluate the effect of the WeChat group intervention.
RESULTS
In the WeChat group versus the control group, the median symptom onset to first medical contact time was similar (129 vs 150 min, p > 0.05), but the median first medical contact to wire, door to wire and first medical contact to catheterization laboratory activity were significantly shorter (132 vs 171 minutes, p < 0.001; 60 vs 95 minutes, p < 0.001; 29 vs 74 minutes, p < 0.001, respectively).
CONCLUSIONS
Pre-hospital electrocardiography transfer via a WeChat group resulted in earlier reperfusion of ST-elevation myocardial infarction patients who were transferred from the non-percutaneous coronary intervention centre.",2020,,['patients with ST-segment myocardial infarction'],[],['reperfusion time'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]",[],"[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0102293,,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Haojia', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Shushuang', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Shantou University Medical College, China.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19856473']
930,31415306,"Maternal Depressive Symptoms and Perceived Picky Eating in a Low-Income, Primarily Hispanic Sample.","OBJECTIVE
Feeding concerns are common in the first 2 years of life and typically reflect maternal perceptions occurring within the larger context of the parent-child relationship. We aimed to determine whether (1) maternal depressive systems predicted perceived picky eating, mediated by maternal negative perceptions; (2) receipt of the Video Interaction Project (VIP) parenting intervention impacted perceived picky eating through this pathway; and (3) perceived picky eating was associated with child growth or subsequent dietary patterns.
METHODS
We performed a partial longitudinal analysis of 187 low-income, predominantly Hispanic mother-child dyads enrolled in a randomized controlled trial of the VIP. Mother-infant dyads were enrolled postpartum in an urban public hospital. Participants randomized to the VIP met with an interventionist on days of well-child visits; sessions were designed to facilitate interactions in play and shared reading through provision of learning materials and review of videotaped parent-child interaction; the curriculum did not contain feeding-specific elements. We used structural equation modeling to determine direct, indirect, and total effects of maternal depressive symptoms, maternal negative perceptions, and the VIP on perceived picky eating. We then tested associations between perceived picky eating and (1) child growth, using multivariable linear regression and multilevel modeling; and (2) subsequent child dietary consumption, using multivariable multinomial logistic regression.
RESULTS
Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders. This effect was partially mediated by maternal negative perceptions (indirect effect: β = 0.06, p = 0.04). When used in the model as the predictor, the VIP had a significant total effect on perceived picky eating (β = -0.16, p = 0.02), which was partially mediated by maternal depressive symptoms and negative perceptions (indirect effect: β = -0.05, p = 0.02). Perceived picky eating was not associated with child diet at age 2 years or adiposity from 6 months to 3 years.
CONCLUSION
Maternal concerns about picky eating may reflect deeper depressive symptoms and negative perceptions of her child's behavior. Interventions designed to facilitate positive parenting in general may lessen feeding-specific concerns, such as picky eating. Although reassurance about growth and nutritional outcomes for children perceived as picky eaters is appropriate, clinicians should also consider probing for underlying symptoms of depression that could lead to eating concerns.",2019,"RESULTS
Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders.","['Mother-infant dyads were enrolled postpartum in an urban public hospital', '187 low-income, predominantly Hispanic mother-child dyads enrolled']",['Video Interaction Project (VIP) parenting intervention impacted perceived picky eating through this pathway; and (3) perceived picky eating was associated with child growth or subsequent dietary patterns'],"['Perceived picky eating', 'Maternal Depressive Symptoms and Perceived Picky Eating', 'negative maternal perceptions', 'maternal depressive symptoms and negative perceptions', 'perceived picky eating']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",187.0,0.0759602,"RESULTS
Maternal depressive symptoms had significant total effects on negative maternal perceptions (β = 0.32, p < 0.001) and perceived picky eating (β = 0.21, p < 0.01) after controlling for potential confounders.","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Katzow', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Canfield', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Carolyn Brockmeyer', 'Initials': 'CB', 'LastName': 'Cates', 'Affiliation': 'Department of Psychology, State University of New York at Purchase, Harrison, NY.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weisleder', 'Affiliation': 'Department of Communication Sciences and Disorders, Northwestern University, Evanston, IL.'}, {'ForeName': 'Samantha Berkule', 'Initials': 'SB', 'LastName': 'Johnson', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Division of Developmental-Behavioral Pediatrics, Department of Pediatrics, New York University School of Medicine, New York, NY.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000715']
931,31945816,"The Efficacy and Safety of GCWB104 (Flos Lonicera Extract) in Functional Dyspepsia: A Single-Center, Randomized, Double-Blind, Placebo-Controlled Study.","Background/Aims: The Flos Lonicera extract GCWB104 has been shown to have significant protective effects against gastritis and gastric ulcers in vivo. The aim of this study was to investigate the efficacy and safety of GCWB104 in subjects with functional dyspepsia (FD). Methods: In this single-center, double-blind, randomized clinical trial, 92 subjects diagnosed with FD using the Rome III criteria were allocated to either the test group (300 mg of GCWB104, containing 125 mg of Flos Lonicera extract, twice daily) or the placebo group (300 mg placebo, twice daily). The total score improvement on the Gastrointestinal Symptom Rating Scale (GSRS) for individual symptoms, changes in antioxidant levels, changes in dyspepsia-related quality of life according to the Nepean Dyspepsia Index (NDI), and adverse effects were compared before and after 8 weeks of treatment. Results: The differences in total GSRS scores and score improvements after 8 weeks of treatment were significant between the GCWB104 and control groups (p=0.0452 and p=0.0486, respectively). Thirteen of 15 individual symptoms on the GSRS improved in the GCWB104 group, while six symptoms improved in the control group. In addition, statistically significant changes in rumbling, loose stool, and stool urgency were observed in the GCWB104 group. Blood 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels, known as antioxidants, showed significant reductions after 8 weeks of administration of GCWB104. There were no adverse events related to treatment with GCWB104. Conclusions: GCWB104 safely contributed to improvements in mild to moderate FD and irritable bowel syndrome symptoms. Antioxidant effects of GCWB104 were also suggested (Clinicaltrials.gov number NCT04008901).",2020,"The total score improvement on the Gastrointestinal Symptom Rating Scale (GSRS) for individual symptoms, changes in antioxidant levels, changes in dyspepsia-related quality of life according to the Nepean Dyspepsia Index (NDI), and adverse effects were compared before and after 8 weeks of treatment.","['92 subjects diagnosed with FD using the Rome III criteria', 'subjects with functional dyspepsia (FD', 'Functional Dyspepsia']","['GCWB104', 'placebo', 'Placebo', 'GCWB104, containing 125 mg of ', 'GCWB104 (Flos Lonicera Extract']","['Gastrointestinal Symptom Rating Scale (GSRS) for individual symptoms, changes in antioxidant levels, changes in dyspepsia-related quality of life according to the Nepean Dyspepsia Index (NDI), and adverse effects', 'Antioxidant effects of GCWB104', 'efficacy and safety', 'rumbling, loose stool, and stool urgency', 'GSRS', 'total GSRS scores and score improvements', ""Blood 8-hydroxy-2'-deoxyguanosine (8-OHdG) levels""]","[{'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0331065', 'cui_str': 'Honeysuckle'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3179302', 'cui_str': 'Anti-Oxidant Effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2129214', 'cui_str': 'Loose stool (finding)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0050078', 'cui_str': ""2'-deoxy-8-oxo-7,8-dihydroguanosine""}]",92.0,0.384312,"The total score improvement on the Gastrointestinal Symptom Rating Scale (GSRS) for individual symptoms, changes in antioxidant levels, changes in dyspepsia-related quality of life according to the Nepean Dyspepsia Index (NDI), and adverse effects were compared before and after 8 weeks of treatment.","[{'ForeName': 'Yonghoon', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Gi Tark', 'Initials': 'GT', 'LastName': 'Noh', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Ju Yup', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.'}]",Gut and liver,['10.5009/gnl19283']
932,31432220,The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.,"PURPOSE
The prospective randomized multicenter Freeway study evaluated the possible hemodynamic and clinical benefits of primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB) over post-stent insertion PTA with standard balloons in the treatment of symptomatic femoropopliteal arteriosclerotic lesions.
METHODS
In total, 204 patients in 13 centers in Germany and Austria were enrolled and randomized to primary stenting followed by either FREEWAY™ drug-eluting balloon or standard PTA balloon angioplasty. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 6 months; the secondary endpoints include TLR rate at 12 months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE) at 6 and 12 months. Lesion characteristics and vessel patency were analyzed by an independent and blinded corelab.
RESULTS
At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively). Primary patency was significantly better for patients treated with the DEB at 6 months (90.3% vs. 69.8% p = 0.001) and 12 months (77.4% vs. 61.0% p = 0.027). Improvement in Rutherford classifications was likewise significantly better for patients in the DEB group at 6 (94.9% vs. 84.3% p = 0.027) and 12 months (95.5% vs. 79.9% p = 0.003). The percentage of patients with an improved ABI of 1.0-1.2 was significantly higher in the DEB group compared to the PTA group at 6 months (55.3% vs. 35.3%; p = 0.015) but without significant difference at 12 months (48.2% vs. 32.9%; p = 0.055). At 6 months, rate of major adverse events (MAE) was 1% in both arms, and at 12 months 2.2% for the DEB and 3.8% for the PTA group.
CONCLUSION
The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group.",2019,"At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively).","['symptomatic femoropopliteal arteriosclerotic lesions', '204 patients in 13 centers in Germany and Austria']","['primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB', 'primary stenting followed by either FREEWAY™ drug-eluting balloon or standard PTA balloon angioplasty', 'Drug-Eluting Balloons Outperform Standard Balloon Angioplasty']","['TLR rate', 'percentage of patients with an improved ABI', 'rate of major adverse events (MAE', 'TLR rate at 12\xa0months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE', 'Primary patency', 'rate of clinically driven target lesion revascularization (TLR', 'Lesion characteristics and vessel patency']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent (procedure)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous Transluminal Angioplasty'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0442647', 'cui_str': 'Freeway'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}]",204.0,0.0603388,"At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively).","[{'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Tacke', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Klinikum Passau, Innstraße 76, 94036, Passau, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Müller-Hülsbeck', 'Affiliation': 'Radiologie, Diakonissenkrankenhaus Flensburg, Knuthstraße 1, 24939, Flensburg, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'Jüdisches Krankenhaus Berlin, Gemeinschaftspraxis für Radiologie, Neuroradiologie & Zentrum für Minimal Invasive Therapie am Jüdischen Krankenhaus Berlin, Heinz-Galinski-Str. 1, 13347, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Lammer', 'Affiliation': 'Kardiovaskuläre und Interventionelle Radiologie, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Vienna, Austria. johannes.lammer@meduniwien.ac.at.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schürmann', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie St.-Johannes-Hospital Dortmund, Johannesstraße 9-17, 44137, Dortmund, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gross-Fengels', 'Affiliation': 'Radiologie und Nuklearmedizin, Asklepios Klinik Harburg, Eißendorfer Pferdeweg 52, 21075, Hamburg, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Fischbach', 'Affiliation': 'Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinik Altona, Paul-Ehrlich-Str. 1, 22763, Hamburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Textor', 'Affiliation': 'Abteilung für Radiologie Gemeinschaftskrankenhaus Bonn, St. Elisabeth/St. Petrus/St. Johannes gGmbH, Bonner Talweg 4-6, 53113, Bonn, Germany.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Boguth', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie, Klinikum Idar-Oberstein GmbH, Dr.-Ottmar-Kohler Str. 2, 55743, Idar-Oberstein, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loewe', 'Affiliation': 'Kardiovaskuläre und Interventionelle Radiologie, Medizinische Universität Wien, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Hannes', 'Initials': 'H', 'LastName': 'Häuser', 'Affiliation': 'Klinik für Diagnostische und Interventionelle Radiologie, Klinikum St. Elisabeth Straubing GmbH, St.-Elisabeth-Str. 23, 94315, Straubing, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Gschwendtner', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie, KH Elisabethinen Linz, Fadingerstrasse 1, 4010, Linz, Austria.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Tepe', 'Affiliation': 'Radiologie, Klinikum Rosenheim, Pettenkoferstr. 10, 83022, Rosenheim, Germany.'}, {'ForeName': 'Rembert Pogge', 'Initials': 'RP', 'LastName': 'von Strandmann', 'Affiliation': 'Eurocor Tech GmbH, In den Dauen 6a, 53117, Bonn, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Stahnke', 'Affiliation': 'Eurocor Tech GmbH, In den Dauen 6a, 53117, Bonn, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Dambach', 'Affiliation': 'Eurocor Tech GmbH, In den Dauen 6a, 53117, Bonn, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hausegger', 'Affiliation': 'Institut für Diagnostische und Interventionelle Radiologie, Klinikum Klagenfurt am Wörthersee, Feschnigstraße 11, 9020, Klagenfurt, Austria.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-019-02309-3']
933,31429514,Cardiovascular phenotyping for personalized lifestyle treatments of chronic abdominal pain in Irritable Bowel Syndrome: A randomized pilot study.,"BACKGROUND
Different physical exercise interventions for pain and other related symptoms largely follow non-personalized guidelines and show a high degree of variability in outcome. These interventions are considered to have different pathways toward improvement in autonomic regulation of energy metabolism. The current pilot study was conducted to assess the predictive value of individual cardiovascular (CV) activity markers at rest to predict clinical outcomes for two popular exercise-based interventions (walking and yoga) in patients with Irritable Bowel Syndrome (IBS).
METHODS
Twenty-seven adult participants with IBS were randomly assigned to a 16-biweekly Iyengar yoga or walking program. They completed pre- and post-treatment assessments on IBS symptom severity, affective and somatic complaints, and various measures of resting autonomic function including blood pressure (BP), heart rate and its variability, baroreceptor sensitivity (BRS) to activations and inhibitions with gains of brady- and tachycardiac baro-responses, and BP start points for these spontaneous baroreflexes.
RESULTS
Pretreatment BRS was differentially related to clinical response for the treatment groups. Specifically, a significant decrease in pain severity was found in response to yoga for those participants who had lower resting BRS to activations, but decreased pain severity was associated with higher resting BRS for those in the walking group. The effect was not related to affective symptom relief. Other CV measures showed similar associations with clinical outcomes for both groups.
CONCLUSIONS
The data suggest therefore that CV based phenotypes may be useful in personalizing clinical interventions for IBS. They may also point to autonomic mechanisms that are targets for such interventions.",2019,"Specifically, a significant decrease in pain severity was found in response to yoga for those participants who had lower resting BRS to activations, but decreased pain severity was associated with higher resting BRS for those in the walking group.","['patients with Irritable Bowel Syndrome (IBS', 'Twenty-seven adult participants with IBS', 'chronic abdominal pain in Irritable Bowel Syndrome']","['physical exercise interventions', 'popular exercise-based interventions (walking and yoga', '16-biweekly Iyengar yoga or walking program']","['pain severity', 'individual cardiovascular (CV) activity markers', 'IBS symptom severity, affective and somatic complaints, and various measures of resting autonomic function including blood pressure (BP), heart rate and its variability, baroreceptor sensitivity (BRS) to activations and inhibitions with gains of brady- and tachycardiac baro-responses, and BP start points for these spontaneous baroreflexes', 'affective symptom relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0232491', 'cui_str': 'Chronic abdominal pain (finding)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0585332', 'cui_str': 'Biweekly (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0033093', 'cui_str': 'Stretch Receptors, Arterial'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0001726', 'cui_str': 'Affective Symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",27.0,0.0266479,"Specifically, a significant decrease in pain severity was found in response to yoga for those participants who had lower resting BRS to activations, but decreased pain severity was associated with higher resting BRS for those in the walking group.","[{'ForeName': 'Dmitry M', 'Initials': 'DM', 'LastName': 'Davydov', 'Affiliation': 'Laboratory of Neuroimmunopathology, Institute of General Pathology and Pathophysiology, Russian Academy of Sciences, Moscow, Russia.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Shahabi', 'Affiliation': 'Departments of Medicine, Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Naliboff', 'Affiliation': 'Departments of Medicine, Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine at UCLA, Los Angeles, California.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13710']
934,31804580,Randomized Trial of Mindfulness-Based Stress Reduction in Cardiac Patients Eligible for Cardiac Rehabilitation.,"Currently, exercise-based cardiac rehabilitation (CR) is the only recommended secondary prevention strategy for cardiac patients that attempts to tackle stress and psychosocial wellbeing, but it is under-utilized and lacks a comprehensive curriculum for this purpose; hence there is a critical gap to address psychosocial needs of cardiac patients after an event. Mindfulness-based stress reduction (MBSR) has shown benefits in the general population but its role in cardiac patients is not clear. We conducted a pilot randomized controlled trial (RCT) of MBSR in CR-eligible cardiac patients during their initial year of recovery. Patients were allocated 2:1 (intervention:control) to an 8-week MBSR group intervention or usual care. Standard measures of depression, anxiety, perceived stress, health related quality of life (HRQOL), blood pressure, biomarkers (lipids, HbA1c, CRP) and 24-hour Holter monitoring were obtained at baseline, 3- and 9-months post-randomization. Sub-group analyses were performed for participants with at least mild depression (PHQ-9 ≥ 5). 47 patients [mean age 58.6 years; 38% female; 77% white] were enrolled in 2 cohorts. 87% of MBSR patients completed the intervention; study retention was >95% at each follow-up visit. At 3 months, compared to controls, MBSR patients showed improvements in depression [p = 0.01] and anxiety [p = 0.04] with a similar trend in HRQOL [p = 0.06]. The MBSR group showed greater improvement or less worsening of most CV risk factors, with an attenuation of treatment effects at 9 months. Participants with at PHQ-9 scores ≥5 at baseline showed greater improvement in psychosocial and CV outcomes, that persisted at 9 months. MBSR is a safe and well received secondary prevention strategy. This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.",2019,This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.,"['Cardiac Patients Eligible for Cardiac Rehabilitation', 'participants with at least mild depression (PHQ-9\u2009≥\u20095', 'CR-eligible cardiac patients during their initial year of recovery', '47 patients [mean age 58.6 years; 38% female; 77% white']","['MBSR group intervention or usual care', 'MBSR', 'Mindfulness-Based Stress Reduction', 'Mindfulness-based stress reduction (MBSR', 'exercise-based cardiac rehabilitation (CR']","['depression, anxiety, perceived stress, health related quality of life (HRQOL), blood pressure, biomarkers (lipids, HbA1c, CRP) and 24-hour Holter monitoring', 'worsening of most CV risk factors', 'depression', 'psychosocial and CV outcomes', 'anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0588006', 'cui_str': 'Mild depression (disorder)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]",47.0,0.0623392,This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of recovery.,"[{'ForeName': 'Prabhjot S', 'Initials': 'PS', 'LastName': 'Nijjar', 'Affiliation': 'Cardiovascular Division, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA. nijja003@umn.edu.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connett', 'Affiliation': 'Biostatistics, Epidemiology and Research Design (BERD), University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lindquist', 'Affiliation': 'School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Biostatistics, Epidemiology and Research Design (BERD), University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Burt', 'Affiliation': 'Cardiac Rehabilitation, Fairview Health Services, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Pergolski', 'Affiliation': 'Cardiac Rehabilitation, Fairview Health Services, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Wolfe', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Balaji', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Chandiramani', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Kreitzer', 'Affiliation': 'Earl E Bakken Center for Spirituality & Healing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Everson-Rose', 'Affiliation': 'Program in Health Disparities Research, Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}]",Scientific reports,['10.1038/s41598-019-54932-2']
935,29659856,Integration of physical abuse clinical decision support into the electronic health record at a Tertiary Care Children's Hospital.,"Objective
To evaluate the effect of a previously validated electronic health record-based child abuse trigger system on physician compliance with clinical guidelines for evaluation of physical abuse.
Methods
A randomized controlled trial (RCT) with comparison to a preintervention group was performed. RCT-experimental subjects' providers received alerts with a direct link to a physical abuse-specific order set. RCT-control subjects' providers had no alerts, but could manually search for the order set. Preintervention subjects' providers had neither alerts nor access to the order set. Compliance with clinical guidelines was calculated.
Results
Ninety-nine preintervention subjects and 130 RCT subjects (73 RCT-experimental and 57 RCT-control) met criteria to undergo a physical abuse evaluation. Full compliance with clinical guidelines was 84% pre-intervention, 86% in RCT-control group, and 89% in RCT-experimental group. The physical abuse order set was used 43 times during the 7-month RCT. When the abuse order set was used, full compliance was 100%. The proportion of cases in which there was partial compliance decreased from 10% to 3% once the order set became available (P = .04). Male gender, having >10 years of experience and completion of a pediatric emergency medicine fellowship were associated with increased compliance.
Discussion/Conclusion
A child abuse clinical decision support system comprised of a trigger system, alerts and a physical abuse order set was quickly accepted into clinical practice. Use of the physical abuse order set always resulted in full compliance with clinical guidelines. Given the high baseline compliance at our site, evaluation of this alert system in hospitals with lower baseline compliance rates will be more valuable in assessing the efficacy in adherence to clinical guidelines for the evaluation of suspected child abuse.",2018,The proportion of cases in which there was partial compliance decreased from 10% to 3% once the order set became available (P = .04).,"['Ninety-nine preintervention subjects and 130 RCT subjects (73 RCT-experimental and 57 RCT-control) met criteria to undergo a physical abuse evaluation', 'Male gender, having >10 years of experience and completion of a pediatric emergency medicine fellowship', ""Tertiary Care Children's Hospital"", ""Preintervention subjects' providers had neither alerts nor access to the order set""]",['previously validated electronic health record-based child abuse trigger system'],['partial compliance'],"[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1621955', 'cui_str': 'Physical Maltreatment'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1689990', 'cui_str': 'Pediatric emergency medicine'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]","[{'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008060', 'cui_str': 'Child Maltreatment'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.0174958,The proportion of cases in which there was partial compliance decreased from 10% to 3% once the order set became available (P = .04).,"[{'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Suresh', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, PA, USA.""}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Saladino', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, PA, USA.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Fromkin', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, PA, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Heineman', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, PA, USA.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'McGinn', 'Affiliation': 'Department of Medicine, Hofstra Northwell School of Medicine, Manhasset, NY, USA.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Richichi', 'Affiliation': 'Statistical Analysis and Measurement Consultants Inc., Alexandria, VA, USA.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Berger', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, PA, USA.""}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy025']
936,32500449,"An Empirical Comparison of Statistical Methods for Missing Data in Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trials for Chronic Pain and Lipid-Lowering Products.","BACKGROUND
Missing data are uncollected data but meaningful for the statistical analysis due to clinical relevancy of the data for properly specified estimands in clinical trials. Meanwhile the efforts to prevent or minimize missing data are commonly applied in clinical trials, in practice, missing data still occurs. Choosing a statistical method for imputation that deals with missing data targeting specified estimands provides the more reliable estimates of treatment effects.
METHODS
We considered longitudinal clinical settings that have different degrees of missing data and treatment effects, and simulated different missing mechanisms using data from randomized, double-blind, placebo-controlled phase 3 confirmatory clinical trials of approved drugs. We compared four commonly used statistical methods to deal with missing data in clinical trials.
RESULTS
We find that, when the data are missing not at random (MNAR) with higher missing rates, mixed model for repeated measurements (MMRM) method overestimates treatment difference. Pattern-mixture model estimates were seen to be more conservative in our studies than MMRM given MNAR assumptions, which are more realistic with missing data in clinical trials.
CONCLUSIONS
We emphasize the importance of prevention of missing data and specifying the estimand based on trial objectives beforehand. The specified proper estimand and the proper statistical method might be key features to value the clinical trial results despite missing data.",2020,"Choosing a statistical method for imputation that deals with missing data targeting specified estimands provides the more reliable estimates of treatment effects.
",[],"['Placebo', 'placebo']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.409786,"Choosing a statistical method for imputation that deals with missing data targeting specified estimands provides the more reliable estimates of treatment effects.
","[{'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Gnang', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Yoonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. yoonhee.kim@fda.hhs.gov.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Travis', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Yongman', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Office of Biostatistics, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.'}]",Therapeutic innovation & regulatory science,['10.1007/s43441-020-00168-6']
937,32501541,"Pharmacokinetics, safety and tolerability of long-acting parenteral intramuscular injection formulations of doravirine.","WHAT IS KNOWN AND OBJECTIVE
Doravirine is a non-nucleoside reverse transcriptase inhibitor indicated for the treatment of human immunodeficiency virus (HIV)-1 infection. This phase 1 study in healthy adults investigated the pharmacokinetics, safety and tolerability of long-acting parenteral (LAP) microsuspension formulations of doravirine administered as an intramuscular (IM) injection.
METHODS
After confirmation of tolerability and safety of oral doravirine, 36 participants were randomized 1:1:1 to receive IM doravirine 200 mg as Treatment A (1 × 1 mL, 20% [200 mg/mL] suspension), B (1 × 0.66 mL, 30% [300 mg/mL] suspension) or C (2 × 0.5 mL, 20% suspension). Blood samples were taken as venous plasma, venous dried blood spots (DBS) and fingerstick DBS.
RESULTS AND DISCUSSION
Plasma concentration-time profiles following IM treatments demonstrated rapid initial doravirine release, with initial peak ~4 days post-injection, followed by decline over the next ~6 days; a second peak was reached at ~24-36 days, corresponding to prolonged and sustained release, with measurable concentrations up to Day 183. Treatment C was associated with highest peak concentrations and shortest time to maximum concentration. Elimination half-lives for all IM formulations were prolonged versus oral administration (~46-58 days vs ~11-15 hours). Oral doravirine and IM doravirine were generally well tolerated; injection-site pain was the most common adverse event for IM doravirine. Doravirine concentrations from DBS samples showed strong correlations to venous plasma concentrations.
WHAT IS NEW AND CONCLUSIONS
Novel doravirine LAP IM injection formulations investigated in this study demonstrated sustained plasma doravirine concentrations over a course of >20 weeks.",2020,Oral doravirine and IM doravirine were generally well tolerated; injection-site pain was the most common adverse event for IM doravirine.,"['36 participants', 'human immunodeficiency virus (HIV)-1 infection', 'healthy adults']","['IM doravirine 200\xa0mg as Treatment', 'doravirine', 'oral doravirine', 'Oral doravirine and IM doravirine']","['Pharmacokinetics, safety and tolerability', 'venous plasma, venous dried blood spots (DBS) and fingerstick DBS', 'tolerated; injection-site pain', 'pharmacokinetics, safety and tolerability', 'sustained plasma doravirine concentrations', 'rapid initial doravirine release']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3838734', 'cui_str': 'Venous plasma'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",36.0,0.0348717,Oral doravirine and IM doravirine were generally well tolerated; injection-site pain was the most common adverse event for IM doravirine.,"[{'ForeName': 'Ka Lai', 'Initials': 'KL', 'LastName': 'Yee', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Triantafyllou', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Marissa F', 'Initials': 'MF', 'LastName': 'Dockendorf', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Fackler', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'S Aubrey', 'Initials': 'SA', 'LastName': 'Stoch', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Sauzanne G', 'Initials': 'SG', 'LastName': 'Khalilieh', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Iwamoto', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}]",Journal of clinical pharmacy and therapeutics,['10.1111/jcpt.13182']
938,32496624,Clinical and radiographic assessment of circular versus triangular cross-section neck Implants in the posterior maxilla: A 1-year randomized controlled trial.,"OBJECTIVES
Implants with a triangular neck were recently introduced to limit peri-implant bone loss. The primary objective of this randomized controlled trial was to compare peri-implant bone changes of circular versus triangular cross-section neck implants 1 year after loading. The secondary objectives were to assess buccal hard tissue thickness changes, Pink Esthetic Score (PES), and patient satisfaction.
MATERIAL AND METHODS
Thirty four patients requiring replacement of the single, intercalated missing tooth of healed site for at least 4 months in the posterior maxilla were randomized into 2 groups according to the type of implant. Immediately after surgery and 1 year after final restoration, a cone beam CT (CBCT) was performed to assess proximal bone remodeling and buccal bone thickness. Peri-implant soft tissue health, PES, and patient-reported outcome measures (PROMs) were recorded.
RESULTS
No implant loss occurred within the follow-up period. The mean ± SD peri-implant proximal bone loss 1 year after loading was 0.22 ± 0.30 mm for triangular and 0.42 ± 0.67 mm for circular implants necks (p = .25). Peri-implant bone loss exceeding 2 mm was observed in a single implant in the circular neck group. Buccal bone thickness remained stable and did not differ different between the 2 groups. The peri-implant soft tissue health, PES, and patient satisfaction were also comparable.
CONCLUSIONS
Within the limitations of the present study, patient clinical and radiographic outcomes did not differ between triangular and circular cross-section neck implants in the posterior maxilla.",2020,Buccal bone thickness remained stable and did not differ different between the 2 groups.,"['Thirty four patients requiring replacement of the single, intercalated missing tooth of healed site for at least 4 months in the posterior maxilla', 'Posterior Maxilla']","['Circular Versus Triangular cross-section neck Implants', 'circular versus triangular cross-section neck implants 1-year after loading', 'cone beam CT (CBCT']","['implant loss', 'Buccal bone thickness', 'mean ± SD peri-implant proximal bone loss 1-year', 'buccal hard tissue thickness changes, Pink Esthetic Score (PES) and patient satisfaction', 'proximal bone remodeling and buccal bone thickness', 'Peri-implant bone loss']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",34.0,0.145292,Buccal bone thickness remained stable and did not differ different between the 2 groups.,"[{'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Li Manni', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rompen', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Aouini', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Shapira', 'Affiliation': 'Department of Periodontology, Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem, Israel.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}]",Clinical oral implants research,['10.1111/clr.13624']
939,31814664,Comparison of Single-Dose Infraclavicular Brachial Plexus Block and Continuous Infraclavicular Brachial Plexus Block Applications in the Treatment of Finger Amputations.,"Introduction The aim of this study is to evaluate the replantation success of single-dose infraclavicular brachial plexus block and continuous infraclavicular brachial plexus block (CIBPB) applied with bupivacaine and prilocaine in patients with finger amputation. Materials and Methods This prospective randomized nonblinded study was conducted between January 2012 and September 2017, and 47 patients, all male, were included. Patients were randomly separated into two groups as 23 patients CIBPB applied group (group A) and 24 patients single-dose infraclavicular block applied group (group B). In group B, after the effect of block is ceased, intravenous patient-controlled (PC) opioid analgesia and, where necessary, 1 mg/kg meperidine and 75 mg diclofenac sodium intramuscularly were alternately administered at 4 to 6 hours intervals. The average ages were 30.7 ± 10.06 and 29 ± 9.08, respectively. Replantations were applied as being two venous anastomoses to one artery, where possible. Hourly skin temperatures of fingers of the hands in which both surgeries applied and no surgery applied in both the groups were measured for 3 days with an infrared thermometer. Also, Numerical Rating Scale (NRS) evaluations in both the groups were performed in 3-hour intervals for 3 days. Results Replantations were successful in 22 patients in whom CIBPB was applied (95.6%) and in 19 patients in whom single block was applied (79.16%). Regarding the finger temperatures, no significant difference was detected between both the groups for 3 days following the operation. No significant difference was found between the length of hospital stays (4.73 ± 2.21-4.71 ± 1.53) and duration of operations (2.90 ± 0.73-2.83 ± 0.58). There was no significant difference between the temperature values of both the groups. NRS scores of group A were statistically significantly lower than those of group B. Conclusion In this prospective randomized study performed by using bupivacaine and prilocaine on 24 patients, the success rate of finger replantations with CIBPB was found to be higher. CIBPB is a very beneficial method that should be taken in consideration in hand injuries with anastomosis and high risk of vasospasm. Further studies with more number of cases would help reduce the question marks related with the success of this method.",2019,No significant difference was found between the length of hospital stays (4.73 ± 2.21-4.71 ± 1.53) and duration of operations (2.90 ± 0.73-2.83 ± 0.58).,"['January 2012 and September 2017, and 47 patients, all male, were included', '24 patients', 'patients with finger amputation', 'Finger Amputations']","['diclofenac sodium', 'bupivacaine and prilocaine', 'single-dose infraclavicular brachial plexus block and continuous infraclavicular brachial plexus block (CIBPB', 'Single-Dose Infraclavicular Brachial Plexus Block and Continuous Infraclavicular Brachial Plexus Block Applications', 'meperidine', 'bupivacaine', 'prilocaine', 'CIBPB']","['Hourly skin temperatures of fingers of the hands', 'NRS scores', 'Numerical Rating Scale (NRS) evaluations', 'length of hospital stays', 'success rate of finger replantations with CIBPB']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0177646', 'cui_str': 'Amputation of finger, except thumb (procedure)'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach (procedure)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}]","[{'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]",,0.014896,No significant difference was found between the length of hospital stays (4.73 ± 2.21-4.71 ± 1.53) and duration of operations (2.90 ± 0.73-2.83 ± 0.58).,"[{'ForeName': 'Mehmet Sukru', 'Initials': 'MS', 'LastName': 'Sahin', 'Affiliation': 'Department of Orthopaedics and Traumatology, Alanya Teaching and Medical Research Center, Baskent University, Alanya, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Cakmak', 'Affiliation': 'Department of Orthopaedics and Traumatology, Alanya Teaching and Medical Research Center, Baskent University, Alanya, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Birtay', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Alanya Teaching and Medical Research Centre, Baskent University, Alanya, Turkey.'}]",Journal of hand and microsurgery,['10.1055/s-0039-1681115']
940,32196108,"High-Dose Intravenous Immunoglobulin Is Effective Diabetic Polyneuropathy Resistant to Conventional Treatments. Results of a Double-Blind, Randomized, Placebo-Controlled Trial: Comments.",,2020,,[],"['Placebo', 'Immunoglobulin']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}]",[],,0.71449,,"[{'ForeName': 'Tze Chao', 'Initials': 'TC', 'LastName': 'Wee', 'Affiliation': 'Department of Rehabilitation Medicine, Changi General Hospital, Singapore.'}, {'ForeName': 'Yeow Leng', 'Initials': 'YL', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, Singapore General Hospital, Singapore.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa057']
941,32139550,Substantial and sustained improvement of serrated polyp detection after a simple educational intervention: results from a prospective controlled trial.,"OBJECTIVE
Serrated polyps (SPs) are an important cause of postcolonoscopy colorectal cancers (PCCRCs), which is likely the result of suboptimal SP detection during colonoscopy. We assessed the long-term effect of a simple educational intervention focusing on optimising SP detection.
DESIGN
An educational intervention, consisting of two 45 min training sessions (held 3 years apart) on serrated polyp detection, was given to endoscopists from 9 Dutch hospitals. Hundred randomly selected and untrained endoscopists from other hospitals were selected as control group. Our primary outcome measure was the proximal SP detection rate (PSPDR) in trained versus untrained endoscopists who participated in our faecal immunochemical test (FIT)-based population screening programme.
RESULTS
Seventeen trained and 100 untrained endoscopists were included, who performed 11 305 and 51 039 colonoscopies, respectively. At baseline, PSPDR was equal between the groups (9.3% vs 9.3%). After training, the PSPDR of trained endoscopists gradually increased to 15.6% in 2018. This was significantly higher than the PSPDR of untrained endoscopists, which remained stable around 10% (p=0.018). All below-average (ie, PSPDR ≤6%) endoscopists at baseline improved their PSPDR after training session 1, as did 57% of endoscopists with average PSPDR (6%-12%) at baseline. The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training.
CONCLUSION
A simple educational intervention was associated with substantial long-term improvement of PSPDR in a prospective controlled trial within FIT-based population screening. Widespread implementation of such interventions might be an easy way to improve SP detection, which may ultimately result in fewer PCCRCs.
TRIAL REGISTRATION NUMBER
NCT03902899.",2020,"The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training.
","['Seventeen trained and 100 untrained endoscopists were included, who performed 11\u2009305 and 51\u2009039 colonoscopies, respectively', 'Hundred randomly selected and untrained endoscopists from other hospitals were selected as control group']",['simple educational intervention'],"['PSPDR of trained endoscopists', 'proximal SP detection rate (PSPDR', 'PSPDR']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}]",0.0,0.0346153,"The second training session further improved the PSPDR in 44% of endoscopists with average PSPDR after the first training.
","[{'ForeName': 'Arne G C', 'Initials': 'AGC', 'LastName': 'Bleijenberg', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'van Leerdam', 'Affiliation': 'Department of Gastroenterology and Hepatology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Bargeman', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Jan Jacob', 'Initials': 'JJ', 'LastName': 'Koornstra', 'Affiliation': 'Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Yasmijn J', 'Initials': 'YJ', 'LastName': 'van Herwaarden', 'Affiliation': 'Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Manon Cw', 'Initials': 'MC', 'LastName': 'Spaander', 'Affiliation': 'Department of Gastroenterology and Hepatology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sanduleanu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Barbara A J', 'Initials': 'BAJ', 'LastName': 'Bastiaansen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Schoon', 'Affiliation': 'Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Lelyveld', 'Affiliation': 'Department of Gastroenterology and Hepatology, Saint Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands e.dekker@amsterdamumc.nl.'}, {'ForeName': 'Joep E G', 'Initials': 'JEG', 'LastName': 'IJspeert', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}]",Gut,['10.1136/gutjnl-2019-319804']
942,31995838,Baricitinib in patients with moderate-to-severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials.,"BACKGROUND
Baricitinib, an oral selective Janus kinase 1 and 2 inhibitor, effectively reduced atopic dermatitis (AD) severity in a phase II study with concomitant topical corticosteroids.
OBJECTIVES
To evaluate the efficacy and safety of baricitinib in patients with moderate-to-severe AD who had an inadequate response to topical therapies.
METHODS
In two independent, multicentre, double-blind, phase III monotherapy trials, BREEZE-AD1 and BREEZE-AD2, adults with moderate-to-severe AD were randomized 2 : 1 : 1 : 1 to once-daily placebo, baricitinib 1 mg, 2 mg, or 4 mg for 16 weeks.
RESULTS
At week 16, more patients achieved the primary end point of Validated Investigator's Global Assessment of AD (0, 1) on baricitinib 4 mg and 2 mg compared with placebo in BREEZE-AD1 [N = 624; baricitinib 4 mg 16·8% (P < 0·001), 2 mg 11·4% (P < 0·05), 1 mg 11·8% (P < 0·05), placebo 4·8%], and BREEZE-AD2 [N = 615; baricitinib 4 mg 13·8% (P = 0·001), 2 mg 10·6% (P < 0·05), 1 mg 8·8% (P = 0·085), placebo 4·5%]. Improvement in itch was achieved as early as week 1 for 4 mg and week 2 for 2 mg. Improvements in night-time awakenings, skin pain and quality-of-life measures were observed by week 1 for both 4 mg and 2 mg (P ≤ 0·05, all comparisons). The most common adverse events in patients treated with baricitinib were nasopharyngitis and headache. No cardiovascular events, venous thromboembolism, gastrointestinal perforation, significant haematological changes, or death were observed with any baricitinib dosage.
CONCLUSIONS
Baricitinib improved clinical signs and symptoms in patients with moderate-to-severe AD within 16 weeks of treatment and induced rapid reduction of itch. The safety profile remained consistent with prior findings from baricitinib clinical development in AD, with no new safety concerns.",2020,"Improvements in night-time awakenings, skin pain, and quality-of-life measures were observed by Week 1 for both 4-mg and 2-mg (P≤0.05, all comparisons).","['patients with moderate-to-severe AD', 'Patients with Moderate-to-Severe Atopic Dermatitis', 'adults with moderate-to-severe AD']","['placebo, baricitinib 1-mg, 2-mg or 4-mg for 16 weeks', 'baricitinib', 'Topical Corticosteroids']","['atopic dermatitis (AD) severity', 'efficacy and safety', 'night-time awakenings, skin pain, and quality-of-life measures', 'nasopharyngitis and headache', 'cardiovascular events, venous thromboembolism, gastrointestinal perforation, significant haematological changes, or death', 'clinical signs and symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}]",,0.136248,"Improvements in night-time awakenings, skin pain, and quality-of-life measures were observed by Week 1 for both 4-mg and 2-mg (P≤0.05, all comparisons).","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research, Brisbane, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Galimberti', 'Affiliation': 'Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ""University of California, San Diego and Rady Children's Hospital, San Diego, CA, USA.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bissonnette', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'King', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Thyssen', 'Affiliation': 'Department of Dermatology and Allergy, Herlev and Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology George Washington University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bieber', 'Affiliation': 'Department of Dermatology and Allergy, University of Bonn, Bonn, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tsunemi', 'Affiliation': 'Department of Dermatology, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Costanzo', 'Affiliation': 'Humanitas University and Dermatology Unit, Humanitas Research Hospital, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guttman-Yassky', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Janes', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'DeLozier', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gamalo', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Brinker', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cardillo', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'F P', 'Initials': 'FP', 'LastName': 'Nunes', 'Affiliation': 'Lilly Research Laboratory, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Paller', 'Affiliation': 'Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergology, Ludwig Maximillian University, Munich, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Skinflammation® Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18898']
943,31410516,Loop isolation-based uploading preconditioning to protect heart from damage: a proof-of-concept study.,"BACKGROUND
Little is known on the role of indirect clamp releasing in coronary artery bypass grafting (CABG). Loop isolation-based uploading preconditioning (LiuPhD) was modified to protect the heart from damage and the question of whether this can attenuate reperfusion injury after global myocardial ischemia was examined.
METHODS
A post-hoc comparative analysis was conducted of a prospective single-arm trial on the use of the LiuPhD strategy for 60 multivessel-disease patients undergoing isolated first-time elective on-pump CABG versus 1:1 propensity score-matched patients from the historical database of the same center.
RESULTS
A total of 120 matched patients had a median age of 62.0 (interquartile range [IQR] 55.8-69.0) years, 27 (22.5%) women, 35 (29.2%) with left main disease, and median follow-up of 18.5 (10.9-35.4) months. The LiuPhD group had shorter post-bypass times than conventional controls (10 [6-13] vs 14 [10-19] mins; p = 0.003). The LiuPhD group had similar needs in terms of composite cardiac-specific interventions (38/60 vs 44/60; p = 0.29). At follow-up of safety, the risk for composite major adverse cardiac and cerebrovascular events was similar between groups (event-free survival: 82.3% vs 73.8%; hazard ratio 1.00 [0.39, 2.54], p log-rank test = 0.99).
CONCLUSION
The LiuPhD strategy is associated with short post-bypass times, comparable risk of myocardial injury, and similar safety compared with conventional direct clamp releasing.",2020,"The LiuPhD strategy is associated with short post-bypass times, comparable risk of myocardial injury, and similar safety compared with conventional direct clamp releasing.","['60\xa0multivessel-disease patients undergoing isolated first-time elective on-pump CABG versus 1:1 propensity score-matched patients from the historical database of the same center', '120 matched patients had a median age of 62.0 (interquartile range [IQR] 55.8-69.0) years, 27 (22.5%) women, 35 (29.2%) with left main disease, and median follow-up of 18.5 (10.9-35.4) months', 'coronary artery bypass grafting (CABG']","['LiuPhD strategy', 'Loop isolation-based uploading preconditioning', 'Loop isolation-based uploading preconditioning (LiuPhD']","['shorter post-bypass times', 'composite cardiac-specific interventions', 'risk for composite major adverse cardiac and cerebrovascular events']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0818217,"The LiuPhD strategy is associated with short post-bypass times, comparable risk of myocardial injury, and similar safety compared with conventional direct clamp releasing.","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 300457, Tianjin, China.'}, {'ForeName': 'Dong-Dong', 'Initials': 'DD', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 300457, Tianjin, China.'}, {'ForeName': 'Si-Qiang', 'Initials': 'SQ', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 300457, Tianjin, China.'}, {'ForeName': 'Zhi-Hua', 'Initials': 'ZH', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 300457, Tianjin, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Ding', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 300457, Tianjin, China.'}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 300457, Tianjin, China.'}, {'ForeName': 'Xiao-Cheng', 'Initials': 'XC', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 300457, Tianjin, China. dr.liuxc@foxmail.com.'}]",Herz,['10.1007/s00059-019-04845-7']
944,32499757,Aromatase Inhibitors Plus Weight Loss Improves the Hormonal Profile of Obese Hypogonadal Men Without Causing Major Side Effects.,"Objective: In obese men, the increased expression of the aromatase enzyme in adipose tissue leads to high conversion of androgens to estrogens contributing to hypogonadotropic hypogonadism (HHG). Our objective is to evaluate efficacy and safety of weight loss (WL) plus aromatase inhibitor (AI) therapy in severely obese men with HHG. We hypothesize that AI+WL will be more effective as compared to WL alone in improving the hormonal profile, thus muscle strength and symptoms of HHG (primary outcomes), with no significant adverse effects on lean mass, metabolic profile, and bone mineral density (secondary outcomes). Design: Randomized double-blind placebo-controlled pilot trial. Methods: Twenty-three obese men (BMI≥35 kg/m 2 ), 35-65 years old, were randomized to weight loss (diet and exercise) plus either anastrozole (AI+WL, n = 12) at 1 mg daily or placebo (PBO+WL, n = 11) for 6 months. Inclusion criteria: total testosterone <300 ng/mL (average of 2 measurements), estradiol≥10.9 pg/ml, LH <9 IU/l. Symptoms of hypogonadism by questionnaires; muscle strength by Biodex dynamometer; body composition and bone mineral density by dual-energy X-ray absorptiometry; bone microarchitecture and finite element analysis by high resolution peripheral quantitative-computed tomography. Results: After 6 months of therapy, AI+WL group had higher testosterone ( p = 0.003) and lower estradiol ( p = 0.001) compared to PBO+WL. Changes in symptoms and muscle strength did not differ between groups. AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass. Total and LDL cholesterol reduced more in the PBO+WL group compared to AI+WL ( p = 0.03 for both), who experienced a minimal increase with unlikely meaningful clinical impact. Tibial trabecular bone area decreased more in PBO+WL than AI+WL group for which it remained stable ( p = 0.03). Conclusions: Although AI+WL is effective in reversing the hormonal profile of HHG in severely obese men without causing major side effects, it does not lead to greater improvements in muscle strength and symptoms of hypogonadism compared to WL alone. Clinical Trial Registration : www.ClinicalTrials.gov, identifier: NCT02959853.",2020,AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass.,"['severely obese men', 'severely obese men with HHG', 'obese men', 'Twenty-three obese men (BMI≥35 kg/m 2 ), 35-65 years old', 'Obese Hypogonadal Men']","['weight loss (diet and exercise) plus either anastrozole (AI+WL, n = 12) at 1 mg daily or placebo', 'estradiol≥10.9 pg/ml, LH', 'weight loss (WL) plus aromatase inhibitor (AI) therapy', 'Aromatase Inhibitors Plus Weight Loss', 'placebo']","['lower estradiol', 'Tibial trabecular bone area', 'muscle strength and symptoms of hypogonadism', 'Total and LDL cholesterol', 'higher testosterone', 'lean mass, metabolic profile, and bone mineral density', 'Changes in symptoms and muscle strength']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0860850', 'cui_str': 'Oestradiol decreased'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0241358', 'cui_str': 'Testosterone increased'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",23.0,0.267862,AI+WL resulted in higher fat mass loss than PBO+WL ( p = 0.04) without differences in changes in lean mass.,"[{'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Colleluori', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Christie G', 'Initials': 'CG', 'LastName': 'Turin', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Vigevano', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Clifford', 'Initials': 'C', 'LastName': 'Qualls', 'Affiliation': 'Division of Mathematics and Statistics, University of New Mexico School of Medicine, Albuquerque, NM, United States.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Research Pharmacy, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Mediwala', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Dennis T', 'Initials': 'DT', 'LastName': 'Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Armamento-Villareal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Baylor College of Medicine, Houston, TX, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00277']
945,31809403,Noninvasive Hemodynamic Monitoring of Cocaine-Induced Changes in Cardiac Output and Systemic Vascular Resistance in Subjects With Chronic Cocaine Use Disorder.,"BACKGROUND
Cocaine use disorder (CUD) is a common problem in the United States and worldwide. The mechanisms by which cocaine induces acute cardiovascular toxicity are various. When systemically absorbed through inhaled or intravenous routes, cocaine induces an acute rise in the heart rate (HR) and blood pressure (BP) leading to a significant increase in the cardiac output (CO) and myocardial oxygen demand. Subjects with chronic CUD represent a special population that has experienced long-term cocaine exposure, often without showing signs of cardiovascular disease. We herein present prospectively collected data on the acute hemodynamic effects of intravenous cocaine in a cohort of nontreatment-seeking individuals with CUD without cardiovascular disease.
METHODS AND RESULTS
Baseline physiologic data were collected while participants underwent infusion of escalating doses of cocaine (10, 20, and 40 mg administered over 2 minutes) at baseline and after receiving single-blind placebo treatment. Continuous noninvasive hemodynamic monitoring was performed throughout the infusion sessions using the ccNexfin finger cuffs (Edwards Lifesciences Corp, Irvine, CA). The recorded arterial BP tracings allowed for the measurement of beat-to-beat changes in HR, BP, stroke volume, CO, and systemic vascular resistance (SVR). None of the subjects experienced a treatment-related serious adverse event. Cocaine produced significant dose-dependent increases in median HR, BP, CO, and +dP/dt (a measure of cardiac contractility) and a significant dose-dependent reduction in median SVR.
CONCLUSIONS
Intravenous cocaine in a cohort of otherwise healthy subjects with CUD produced dose-dependent increases in CO, largely explained by an increase in HR, accompanied by a dose-dependent decrease in SVR.",2019,"Cocaine produced significant dose-dependent increases in median HR, BP, CO, and +dP/dt (a measure of cardiac contractility) and a significant dose-dependent reduction in median SVR.
","['Subjects with chronic CUD', 'Subjects With Chronic Cocaine Use Disorder', 'cohort of nontreatment-seeking individuals with CUD without cardiovascular disease']","['placebo', 'Cocaine', 'cocaine']","['SVR', 'heart rate (HR) and blood pressure (BP', 'HR, BP, stroke volume, CO, and systemic vascular resistance (SVR', 'cardiac output (CO) and myocardial oxygen demand', 'median SVR', 'Cardiac Output and Systemic Vascular Resistance', 'recorded arterial BP tracings', 'acute cardiovascular toxicity', 'median HR, BP, CO, and +dP/dt (a measure of cardiac contractility']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0741744,"Cocaine produced significant dose-dependent increases in median HR, BP, CO, and +dP/dt (a measure of cardiac contractility) and a significant dose-dependent reduction in median SVR.
","[{'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Van Tassell', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Westman', 'Affiliation': 'Pauley Heart Center, School of Medicine, Richmond, VA.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Trankle', 'Affiliation': 'Pauley Heart Center, School of Medicine, Richmond, VA.'}, {'ForeName': 'Sade', 'Initials': 'S', 'LastName': 'Johns', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Kadariya', 'Affiliation': 'Institute of Drug and Alcohol Studies.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Buckley', 'Affiliation': 'Department of Pharmacotherapy, School of Pharmacy, Richmond, VA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Institute of Drug and Alcohol Studies.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Abbate', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}, {'ForeName': 'Frederick Gerard', 'Initials': 'FG', 'LastName': 'Moeller', 'Affiliation': 'Wright Center for Clinical and Translational Research, Richmond, VA.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000740']
946,31811206,An abluminal biodegradable polymer sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients undergoing coronary revascularization: 3-year clinical outcomes of a randomized non-inferiority trial.,"The Cordimax stent has proved non-inferior to the Cypher Select durable polymer sirolimus-eluting stent for the primary endpoint of angiographic in-stent late luminal loss and in-stent mean diameter stenosis at 9 months. The trial was designed to compare the efficacy and safety of the Cordimax stent with the Xience V stent in patients undergoing coronary revascularization. This randomized, multicenter trial enrolled 3697 patients treated with Cordimax stent (2460 patients) and Xience V stent (1237 patients). The primary efficacy endpoint was a target-lesion failure (TLF) at 1 year and the primary safety endpoint was a composite of death or myocardial infarction (MI) at 3 years. 3399 patients (91.9%) completed 3-year follow-up. At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, P non-inferiority < 0.0001). At 3 years, the primary safety endpoint occurred in 39 (1.6%) patients in the Cordimax group versus 19 (1.5%) patients in the Xience V group (0.05% absolute risk difference, 95% CI -0.8-0.9%, P non-inferiority < 0.0001). The incidence of target lesion revascularization was low in Cordimax group compared with Xience V group (3.6% versus 5.1%, P = 0.03). There were no differences between Cordimax and Xience V in terms of Cardiac death (0.3% versus 0.4%, P = 0.70), myocardial infarction (1.2% versus 0.9%, P = 0.37), and the stent thrombosis (0.4% versus 0.6%, P = 0.61). In conclusion, safety and efficacy outcomes of Cordimax stent were non-inferior to the Xience V stent 3 years after stent implantation.",2019,"At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, P non-inferiority < 0.0001).","['3697 patients treated with', 'patients undergoing coronary revascularization', '2460 patients) and Xience V stent (1237 patients', '3399 patients (91.9%) completed 3-year follow-up']","['sirolimus-eluting stent versus a durable polymer everolimus-eluting stent', 'Cordimax stent with the Xience V stent', 'Cordimax stent']","['incidence of target lesion revascularization', 'composite of death or myocardial infarction (MI', 'Cardiac death', 'myocardial infarction', 'stent thrombosis', 'target-lesion failure (TLF', 'efficacy and safety', 'safety and efficacy outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",3697.0,0.170815,"At 1 year, the primary efficacy endpoint occurred in 86 (3.5%) patients in the Cordimax group versus 40 (3.2%) patients in the Xience V group (0.3% absolute risk difference, 95% CI -1.0-1.5%, P non-inferiority < 0.0001).","[{'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Intervention & Vascular Surgery, Medical College of Tongji University, Shanghai, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Intervention & Vascular Surgery, Medical College of Tongji University, Shanghai, China. zxpkxy@tongji.edu.cn.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Key Laboratory of Public Health Safety, Ministry of Education, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Junwei', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Hou', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Shoutao', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Xiaoshan', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Shenguo', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Institute of Chemistry, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Institute of Chemistry, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Cuihai', 'Initials': 'C', 'LastName': 'Duan', 'Affiliation': 'National Joint Engineering Laboratory for Biomedical Material Modification, Shandong, China.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, Shanghai, China. ge.junbo@zs-hospital.sh.cn.'}]",Scientific reports,['10.1038/s41598-019-54964-8']
947,32140752,"A revalidation and critique of assumptions about urinary sample collection methods, specimen quality and contamination.","INTRODUCTION AND HYPOTHESIS
Midstream urine (MSU) is key in assessing lower urinary tract syndrome (LUTS), but contingent on some assumptions. The aim of this study was to compare the occurrence of contamination and the quality of substrates obtained from four different collections: MSU, catheter specimen urine (CSU), a commercial MSU collecting device (Peezy) and a natural void. Contamination was quantified by differential, uroplakin-positive, urothelial cell counts.
METHODS
This was a single blind, crossover study conducted in two phases. First, we compared the MSU with CSU using urine culture, pyuria counts and differential counting of epithelial cells after immunofluorescence staining for uroplakin III (UP3). Second, we compared the three non-invasive (MSU, Peezy MSU™, natural void) methods using UP3 antibody staining only.
RESULTS
The natural void was best at collecting bladder urinary sediment, with the majority of epithelial cells present derived from the urinary tract. CSU sampling missed much of the urinary sediment and showed sparse culture results. Finally, the MSU collection methods did not capture much of the bladder sediment.
CONCLUSION
We found little evidence for contamination with the four methods. Natural void was the best method for harvesting shed urothelial cells and white blood cells. It provides a richer sample of the inflammatory exudate, including parasitised urothelial cells and the microbial substrate. However, if the midstream sample is believed to be important, the MSU collection device is advantageous.",2020,We found little evidence for contamination with the four methods.,[],['catheter specimen urine (CSU'],[],[],"[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0042037'}]",[],,0.0563349,We found little evidence for contamination with the four methods.,"[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'School of Nursing, Kingston University, Frank Lampl Building, Kingston Hill Campus, London, UK. l.collins@sgul.kingston.ac.uk.'}, {'ForeName': 'Sanchutha', 'Initials': 'S', 'LastName': 'Sathiananthamoorthy', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rohn', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Malone-Lee', 'Affiliation': 'Department of Renal Medicine, Division of Medicine, University College London, London, UK.'}]",International urogynecology journal,['10.1007/s00192-020-04272-x']
948,32500130,"Changes in Perceived Stress After Yoga, Physical Therapy, and Education Interventions for Chronic Low Back Pain: A Secondary Analysis of a Randomized Controlled Trial.","OBJECTIVE
Perceived stress and musculoskeletal pain are common, especially in low-income populations. Studies evaluating treatments to reduce stress in patients with chronic pain are lacking. We aimed to quantify the effect of two evidence-based interventions for chronic low back pain (cLBP), yoga and physical therapy (PT), on perceived stress in adults with cLBP.
METHODS
We used data from an assessor-blinded, parallel-group randomized controlled trial, which recruited predominantly low-income and racially diverse adults with cLBP. Participants (N = 320) were randomly assigned to 12 weeks of yoga, PT, or back pain education. We compared changes in the 10-item Perceived Stress Scale (PSS-10) from baseline to 12- and 52-week follow-up among yoga and PT participants with those receiving education. Subanalyses were conducted for participants with elevated pre-intervention perceived stress (PSS-10 score ≥17). We conducted sensitivity analyses using various imputation methods to account for potential biases in our estimates due to missing data.
RESULTS
Among 248 participants (mean age = 46.4 years, 80% nonwhite) completing all three surveys, yoga and PT showed greater reductions in PSS-10 scores compared with education at 12 weeks (mean between-group difference = -2.6, 95% confidence interval [CI] = -4.5 to -0.66, and mean between-group difference = -2.4, 95% CI = -4.4 to -0.48, respectively). This effect was stronger among participants with elevated pre-intervention perceived stress. Between-group effects had attenuated by 52 weeks. Results were similar in sensitivity analyses.
CONCLUSIONS
Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.",2020,"CONCLUSIONS
Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","['patients with chronic pain are lacking', '248 participants (mean age = 46.4 years, 80% nonwhite', 'adults with cLBP', 'recruited predominantly low-income and racially diverse adults with cLBP', 'Chronic Low Back Pain', 'Participants (N\u2009=\u2009320']","['Physical Therapy, and Education Interventions', 'Yoga and PT', 'yoga and physical therapy (PT']","['PSS-10 scores', '10-item Perceived Stress Scale (PSS-10', 'Perceived Stress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",320.0,0.203356,"CONCLUSIONS
Yoga and PT were more effective than back pain education for reducing perceived stress among low-income adults with cLBP.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Berlowitz', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Joyce', 'Affiliation': 'Department of Rehabilitation Science, Massachusetts General Hospital Institute of Health Professions, Boston, Massachusetts.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Fredman', 'Affiliation': 'Department of Epidemiology, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roseen', 'Affiliation': 'Department of Family Medicine, Boston Medical Center and Boston University School of Medicine, Boston, Massachusetts.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa150']
949,32506563,A Randomized Controlled Trial of Brief Skills Training in Affective and Interpersonal Regulation (STAIR) for Veterans in Primary Care.,"This randomized controlled trial assessed the efficacy of a five-session version of Skills Training in Affective and Interpersonal Regulation (STAIR) among veterans obtaining treatment in primary care. Veterans who screened positive for either posttraumatic stress disorder (PTSD) or depression (N = 26) were enrolled and randomized into either five-session STAIR or treatment as usual (TAU). Assessments of PTSD symptoms (PTSD Checklist for DSM-5; PCL-5), depression (Beck Depression Inventory-II; BDI-II), emotion regulation (Difficulties in Emotion Regulation Scale; DERS), and social engagement difficulties (World Health Organization Disability Assessment 2.0; WHODAS-2) were assessed at pretreatment, posttreatment, and 3-month follow-up assessments. Participants assigned to the five-session STAIR condition reported significant improvements on all measures, whereas those assigned to TAU showed no change. Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2. The results indicate that five-session STAIR, a brief, skills-focused treatment, may be effective in reducing a range of symptoms and in improving social functioning among veterans treated in primary care settings.",2020,"Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2.","['veterans obtaining treatment in primary care', 'Veterans in Primary Care', 'Veterans who screened positive for either posttraumatic stress disorder (PTSD) or depression (N = 26']","['five-session version of Skills Training', 'Brief Skills Training', 'five-session STAIR or treatment as usual (TAU']","['social functioning', 'Affective and Interpersonal Regulation (STAIR', 'PTSD symptoms (PTSD Checklist for DSM-5; PCL-5), depression (Beck Depression Inventory-II; BDI-II), emotion regulation (Difficulties in Emotion Regulation Scale; DERS), and social engagement difficulties (World Health Organization Disability Assessment 2.0; WHODAS-2']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C1704423', 'cui_str': 'Hereditary lymphedema'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",26.0,0.0135656,"Group × Treatment interactions were significant for all outcomes, and effect sizes for the interactions ranged from moderate to large, Hedge's gs = 0.81 for the PCL-5, 1.15 for the BDI-II, 0.75 for the DERS, and 0.81 for the WHODAS-2.","[{'ForeName': 'Shaili', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Kile', 'Initials': 'K', 'LastName': 'Ortigo', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Gimeno', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Denine A', 'Initials': 'DA', 'LastName': 'Baldor', 'Affiliation': 'Integrated Care Team, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Weiss', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}, {'ForeName': 'Marylène', 'Initials': 'M', 'LastName': 'Cloitre', 'Affiliation': 'VA Palo Alto Health Care System, National Center for PTSD Dissemination and Training Division, VA Palo Alto Health Care System, Palo Alto, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22523']
950,31729126,Observational analyses from ADVANCE and ADVANCE-ON.,"AIMS
To explain, and document, the epidemiological work associated with the action in diabetes and vascular disease: preterax and diamicron-modified release controlled evaluation (ADVANCE) clinical trial.
MATERIALS AND METHODS
ADVANCE was designed as a randomized controlled multicentre factorial trial in high-risk patients with diabetes. The two interventions were blood pressure lowering medications versus placebo, and intensive glucose control versus standard glucose control. Following termination of the trial, an observational study of surviving participants, able to join, was mounted: the ADVANCE - observational study (ADVANCE-ON). Other epidemiological analyses that were undertaken treated the trial as a cohort study, including using biomarkers from the blood samples taken from ADVANCE subjects as risk exposures.
RESULTS
More than 50 publications have reported epidemiological results from ADVANCE. The main results from ADVANCE-ON suggested attenuated benefits of ADVANCE's blood pressure lowering treatment on all-cause and cardiovascular death, but no such long-term benefits for intensive glucose control, although this did give persistent benefit for end-stage renal disease. The other epidemiological studies found, amongst other things, strong effects of NT-terminal pro-B-type natriuretic peptide and high-sensitivity cardiac troponin T on macrovascular events, microvascular events and all-cause death.
CONCLUSIONS
Embedding post-randomization and epidemiological analyses into clinical trials is worthwhile and can be highly productive in advancing scientific knowledge.",2020,"Following termination of the trial, an observational study of surviving participants, able to join, was mounted: the ADVANCE - observational study (ADVANCE-ON).",['high-risk patients with diabetes'],"['placebo, and intensive glucose control versus standard glucose control']",['blood pressure lowering medications'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.109797,"Following termination of the trial, an observational study of surviving participants, able to join, was mounted: the ADVANCE - observational study (ADVANCE-ON).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13894']
951,32141320,Effect on Overall Health Status With Weightbearing at 2 Weeks vs 6 Weeks After Open Reduction and Internal Fixation of Ankle Fractures.,"BACKGROUND
Ongoing controversy exists on postoperative weightbearing status after open reduction and internal fixation of an ankle fracture. This prospective randomized controlled trial aimed to compare patient-based and physician-based outcomes after early weightbearing at 2 vs 6 weeks postoperatively.
METHODS
Fifty patients with unstable rotational-type ankle fractures were treated operatively with subsequent immobilization in a below-the-knee cast for 2 weeks and were then randomly allocated to 2 groups. The first group had early weightbearing at 2 weeks postoperation and the second group at 6 weeks postoperation. Follow-up included subjective and objective evaluations performed at 2, 6, 12, and 26 weeks postoperatively. The primary outcome was the patient-based general health status as measured with the EuroQol-5D (EQ-5D) scoring system. Secondary outcome was the Olerud and Molander ankle score. Power analysis revealed a study group of 50 patients was needed to show a clinically relevant effect size of 10 points in both EQ-5D visual analog scale (VAS) score and Olerud and Molander score.
RESULTS
Patients in the early weightbearing group had higher mean EQ-5D VAS scores at a 6-week follow-up ( P = .014) of 77 ± 14 compared to 66 ± 15 for late mobilization. No difference was found at other follow-up points or between groups for physician-based outcome measures. At 26 weeks postoperatively, mean Olerud and Molander ankle scores were similar at 84 ± 16 and 81 ± 17 for mobilization at 2 and 6 weeks postoperation, respectively.
CONCLUSION
Early weightbearing after operative fixation of rotational-type ankle fractures had a clinically relevant and statistically significant benefit in patient-based general health status, as quantified with EQ-5D VAS scores, at 6 weeks postoperation. These results contribute to our understanding of early weightbearing and may encourage consideration of weightbearing at 2 weeks postoperatively in standard protocols.
LEVEL OF EVIDENCE
Therapeutic Level I, prospective randomized controlled trial.",2020,"RESULTS
Patients in the early weightbearing group had higher mean EQ-5D VAS scores at a 6-week follow-up ( P = .014) of 77 ± 14 compared to 66 ± 15 for late mobilization.",['Fifty patients with unstable rotational-type ankle fractures'],[],"['EQ-5D visual analog scale (VAS) score and Olerud and Molander score', 'patient-based general health status as measured with the EuroQol-5D (EQ-5D) scoring system', 'Overall Health Status', 'mean EQ-5D VAS scores', 'mean Olerud and Molander ankle scores', 'Therapeutic Level', 'Internal Fixation of Ankle Fractures', 'EQ-5D VAS scores', 'Olerud and Molander ankle score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0445237', 'cui_str': 'Rotational (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}]",[],"[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0159877', 'cui_str': 'Ankle Fracture'}]",50.0,0.0959215,"RESULTS
Patients in the early weightbearing group had higher mean EQ-5D VAS scores at a 6-week follow-up ( P = .014) of 77 ± 14 compared to 66 ± 15 for late mobilization.","[{'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Schubert', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Kaj T A', 'Initials': 'KTA', 'LastName': 'Lambers', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Kimber', 'Affiliation': 'Department of Orthopaedics, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Denk', 'Affiliation': 'Department of Orthopaedic Surgery, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Cho', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Job N', 'Initials': 'JN', 'LastName': 'Doornberg', 'Affiliation': 'Department of Orthopaedic Surgery, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Ruurd L', 'Initials': 'RL', 'LastName': 'Jaarsma', 'Affiliation': 'Department of Orthopaedics and Trauma Surgery, Flinders University, Adelaide, South Australia, Australia.'}]",Foot & ankle international,['10.1177/1071100720908853']
952,32142135,Hypoalgesic Effects of Aerobic and Isometric Motor Imagery and Action Observation Exercises on Asymptomatic Participants: A Randomized Controlled Pilot Trial.,"OBJECTIVES
The objective was to explore whether action observation (AO) and motor imagery (MI) of aerobic and isometric exercise could induce hypoalgesic responses in asymptomatic individuals compared with placebo observation (PO).
METHODS
A randomized controlled pilot trial was designed. Twenty-four healthy participants (mean age = 21.9 ± 2.1 years) were randomized into three groups: AO+MI (N = 8), AO, (N = 8), and PO (N = 8). All participants performed an actual aerobic running exercise (three series of 90 seconds at 85% of their VO2max and 30 seconds at 65% of their VO2max) and an isometric exercise protocol (isometric squats). A day later, they all performed the mental intervention, observing or imagining exercise execution performed the day before, according to their allocated group. Pressure pain thresholds (PPTs) of the quadriceps and epicondyle regions were assessed at baseline, postintervention, and 15 minutes postintervention.
RESULTS
Analysis of variance revealed statistically significant differences in the group*time interaction for PPT in the quadriceps. The AO group showed a statistically significant increase at postintervention and at 15 minutes postintervention. The AO+MI group obtained a statistically significant increase in the two PPT regions compared with the PO group at Δpre-post. The AO group obtained a greater increase in the PPT in the quadriceps femoris than the PO group at Δpre-post and Δpre-post 15 minutes.
CONCLUSIONS
AO and MI induce hypoalgesic responses compared with PO. AO isolated training showed pain modulation responses in the PPTs of the quadriceps region in young physically active adults. These findings highlight the potential role of brain training in pain management.",2020,"The AO group obtained a greater increase in the PPT in the quadriceps femoris than the PO group at Δpre-post and Δpre-post 15 minutes.
","['young physically active adults', 'Twenty-four healthy participants (mean age = 21.9\u2009±\u20092.1 years', 'Asymptomatic Participants', 'asymptomatic individuals compared with placebo observation (PO']","['isometric exercise protocol (isometric squats', 'action observation (AO) and motor imagery (MI) of aerobic and isometric exercise', 'brain training', 'Aerobic and Isometric Motor Imagery and Action Observation Exercises', 'actual aerobic running exercise', 'AO isolated training']","['Pressure pain thresholds (PPTs) of the quadriceps and epicondyle regions', 'pain modulation responses', 'hypoalgesic responses']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0222681', 'cui_str': 'Structure of epicondyle'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",24.0,0.0463063,"The AO group obtained a greater increase in the PPT in the quadriceps femoris than the PO group at Δpre-post and Δpre-post 15 minutes.
","[{'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'Fernández Pérez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Martínez García', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Ibai', 'Initials': 'I', 'LastName': 'López-de-Uralde-Villanueva', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Motion in Brains Research Group, Institute of Neuroscience and Sciences of the Movement (INCIMOV), Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, Madrid, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa015']
953,32501109,Temporary Bridge Plating vs Primary Arthrodesis of the First Tarsometatarsal Joint in Lisfranc Injuries: Randomized Controlled Trial.,"BACKGROUND
Unstable Lisfranc injuries are best treated with anatomic reduction and stable fixation. There are controversies regarding which type of stabilization is best. In the present study, we compared primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating in unstable Lisfranc injuries.
METHODS
Forty-eight patients with Lisfranc injuries were included and followed for 2 years. Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients were randomized to temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints. The main outcome parameter was the American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale and the secondary outcome parameters were the 36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain). Computed tomography (CT) scans pre- and postoperatively were obtained. Radiographs were obtained at follow-ups. Pedobarographic examination was performed at the 2-year follow-up. Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up.
RESULTS
The mean AOFAS midfoot score 2 years postoperatively was 89 (SD 9) in the PA group and 85 (SD 15) in the BP group ( P = .32). There were no significant differences between the groups with regard to SF-36 or VAS pain scores. The alignment of the first metatarsal was better in the BP group than in the PA group measured by the anteroposterior Meary angle ( P = .04). The PA group had a reduced peak pressure under the fifth metatarsal ( P = .047). In the BP group, 11/24 patients had radiologic signs of osteoarthritis in the first TMT joint.
CONCLUSION
Both treatment groups had good outcome scores. The first metatarsal was better aligned in the BP group; however, there was a high incidence of radiographic osteoarthritis in this group.
LEVEL OF EVIDENCE
Therapeutic level I, prospective randomized controlled study.",2020,There were no significant differences between the groups with regard to SF-36 or VAS pain scores.,"['Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients', 'Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up', 'Lisfranc Injuries', 'Forty-eight patients with Lisfranc injuries were included and followed for 2 years']","['primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating', 'temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints', 'Temporary Bridge Plating vs Primary Arthrodesis']","['peak pressure', 'Therapeutic level', 'mean AOFAS midfoot score', 'SF-36 or VAS pain scores', 'American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale', 'radiographic osteoarthritis', '36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain', 'radiologic signs of osteoarthritis']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224724', 'cui_str': 'Structure of tarsometatarsal joint'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4523968', 'cui_str': 'Lisfranc injury'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0447821', 'cui_str': 'First tarsometatarsal joint'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0447823', 'cui_str': 'Third tarsometatarsal joint'}]","[{'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0932074', 'cui_str': 'Midfoot region of foot'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",48.0,0.0430063,There were no significant differences between the groups with regard to SF-36 or VAS pain scores.,"[{'ForeName': 'Are H', 'Initials': 'AH', 'LastName': 'Stødle', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kjetil H', 'Initials': 'KH', 'LastName': 'Hvaal', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helga M', 'Initials': 'HM', 'LastName': 'Brøgger', 'Affiliation': 'Department of Radiology and Nuclear medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elisabeth Ellingsen', 'Initials': 'EE', 'LastName': 'Husebye', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Foot & ankle international,['10.1177/1071100720925815']
954,32504272,"Validation of a Drug Transporter Probe Cocktail Using the Prototypical Inhibitors Rifampin, Probenecid, Verapamil, and Cimetidine.","BACKGROUND AND OBJECTIVE
A novel cocktail containing four substrates of key drug transporters was previously optimized to eliminate mutual drug-drug interactions between the probes digoxin (P-glycoprotein substrate), furosemide (organic anion transporter 1/3), metformin (organic cation transporter 2, multidrug and toxin extrusion protein 1/2-K), and rosuvastatin (organic anion transporting polypeptide 1B1/3, breast cancer resistance protein). This clinical trial investigated the effects of four commonly employed drug transporter inhibitors on cocktail drug pharmacokinetics.
METHODS
In a randomized open-label crossover trial in 45 healthy male subjects, treatment groups received the cocktail with or without single oral doses of rifampin, verapamil, cimetidine or probenecid. Concentrations of the probe drugs in serial plasma samples and urine fractions were measured by validated liquid chromatography-tandem mass spectrometry assays to assess systemic exposure.
RESULTS
The results were generally in accordance with known in vitro and/or clinical drug-drug interaction data. Single-dose rifampin increased rosuvastatin area under the plasma concentration-time curve up to the last quantifiable concentration (AUC 0-tz ) by 248% and maximum plasma concentration (C max ) by 1025%. Probenecid increased furosemide AUC 0-tz by 172% and C max by 23%. Cimetidine reduced metformin renal clearance by 26%. The effect of single-dose verapamil on digoxin systemic exposure was less than expected from multiple-dose studies (AUC 0-tz unaltered, C max + 22%).
CONCLUSIONS
Taking all the interaction results together, the transporter cocktail is considered to be validated as a sensitive and specific tool for evaluating transporter-mediated drug-drug interactions in drug development.
CLINICAL TRIAL REGISTRATION
EudraCT number 2017-001549-29.",2020,Single-dose rifampin increased rosuvastatin area under the plasma concentration-time curve up to the last quantifiable concentration (AUC 0-tz ) by 248% and maximum plasma concentration (C max ) by 1025%.,['45 healthy male subjects'],"['verapamil', 'furosemide (organic anion transporter 1/3), metformin (organic cation transporter 2, multidrug and toxin extrusion protein 1/2-K), and rosuvastatin', 'Probenecid, Verapamil, and Cimetidine', 'Cimetidine', 'cocktail with or without single oral doses of rifampin, verapamil, cimetidine or probenecid', 'Probenecid']","['serial plasma samples and urine fractions', 'metformin renal clearance', 'digoxin systemic exposure', 'furosemide AUC 0-tz']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0949791', 'cui_str': 'OATP Proteins'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1453694', 'cui_str': 'SLC22A2 protein, human'}, {'cui': 'C0040549', 'cui_str': 'Toxin'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0033209', 'cui_str': 'Probenecid'}, {'cui': 'C0008783', 'cui_str': 'Cimetidine'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",45.0,0.0787025,Single-dose rifampin increased rosuvastatin area under the plasma concentration-time curve up to the last quantifiable concentration (AUC 0-tz ) by 248% and maximum plasma concentration (C max ) by 1025%.,"[{'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Wiebe', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Giessmann', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Hohl', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schmidt-Gerets', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Hauel', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'CTC North GmbH & Co KG, University Medical Centre Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Bader', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': 'Kobe Pharma Research Institute, Nippon Boehringer Ingelheim Co. Ltd., Chuo-ku, Kobe, Japan.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Taub', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ebner', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Mikus', 'Affiliation': 'UniversitätsKlinikum Heidelberg-Medizinische Klinik, Abteilung Klinische Pharmakologie and Pharmakoepidemiologie, Heidelberg, Germany.'}, {'ForeName': 'Martin F', 'Initials': 'MF', 'LastName': 'Fromm', 'Affiliation': 'Institute of Experimental and Clinical Pharmacology and Toxicology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Stopfer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany. Peter.Stopfer@boehringer-ingelheim.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00907-w']
955,32511775,Effects of adjunctive probiotic L. reuteri lozenges on S/RSD outcomes at molar sites with deep pockets.,"AIM
To evaluate effects of probiotic Lactobacillus reuteri (L. reuteri) lozenges as an S/RSD adjunct on site-level changes at molars with deep pockets.
MATERIALS AND METHODS
447 molar sites with pockets ≥ 5 mm from a previous randomized clinical trial of adjunctive L. reuteri lozenges for 28 days were analyzed. Multilevel mixed-effect models (MLM) were constructed to analyze site-level outcomes ""change in CAL"" and ""pocket closure"" (residual PPD < 5 mm) in placebo and probiotic groups at 90 and 180 days. Possible patient-, tooth-, and site-level predictors were analyzed as fixed-effects.
RESULTS
Estimated change in CAL in probiotic (90 day: 0.87 mm, 180 day: 0.68 mm) was greater than placebo treated molar sites (90 day: 0.73 mm, 180 day: 0.66 mm) and the relative risk (RR) of pocket closure in the probiotic group (90 day: 1.7, 180 day: 1.6) was higher as compared to placebo. Furcation involvement and BOP at site predicted significantly worse treatment outcomes.
CONCLUSION
As compared to S/RSD with placebo, a 28-day course of adjunctive probiotic L. reuteri lozenges improved CAL change at molar sites with ≥ 5 mm deep pockets and conferred a higher probability of shallow residual pocket depth. Presence of furcation-involvement and bleeding on probing worsened treatment outcomes.",2020,"Furcation involvement and BOP at site predicted significantly worse treatment outcomes.
","['at molar sites with deep pockets', '447 molar sites with pockets ≥ 5mm from a previous randomized clinical trial of', 'site-level changes at molars with deep pockets']","['adjunctive L. reuteri lozenges', 'probiotic Lactobacillus reuteri (L. reuteri) lozenges', 'adjunctive probiotic L. reuteri lozenges', 'placebo']","['Furcation involvement and BOP', 'CAL change', 'S/RSD outcomes', 'relative risk (RR) of pocket closure']","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",,0.290731,"Furcation involvement and BOP at site predicted significantly worse treatment outcomes.
","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Pelekos', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Aneesha', 'Initials': 'A', 'LastName': 'Acharya', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Nemoto', 'Initials': 'N', 'LastName': 'Eiji', 'Affiliation': 'Department of Periodontology and Endodontology, Tohoku University Graduate School of Dentistry, Sendai, Japan.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Liaison Center for Innovative Dentistry, Tohoku University Graduate School of Dentistry, Sendai, Japan.'}, {'ForeName': 'Wai Keung', 'Initials': 'WK', 'LastName': 'Leung', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}]",Journal of clinical periodontology,['10.1111/jcpe.13329']
956,32503517,Online yoga to reduce post traumatic stress in women who have experienced stillbirth: a randomized control feasibility trial.,"BACKGROUND
About 1 in every 150 pregnancies end in stillbirth. Consequences include symptoms of post traumatic stress disorder (PTSD), depression, and anxiety. Yoga has been used to treat PTSD in other populations and may improve health outcomes for stillbirth mothers. The purpose of this study was to determine: (a) feasibility of a 12-week home-based, online yoga intervention with varying doses; (b) acceptability of a ""stretch and tone"" control group; and (c) preliminary efficacy of the intervention on reducing symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health.
METHODS
Participants (N = 90) were recruited nationally and randomized into one of three groups for yoga or exercise (low dose (LD), 60 min per week; moderate dose (MD), 150 min per week; and stretch-and-tone control group (STC)). Baseline and post-intervention surveys measured main outcomes (listed above). Frequency analyses were used to determine feasibility. Repeated measures ANCOVA were used to determine preliminary efficacy. Multiple regression analyses were used to determine a dose-response relationship between minutes of yoga and each outcome variable.
RESULTS
Over half of participants completed the intervention (n = 48/90). Benchmarks (≥70% reported > 75% satisfaction) were met in each group for satisfaction and enjoyment. Participants meeting benchmarks (completing > 90% of prescribed minutes 9/12 weeks) for LD and MD groups were 44% (n = 8/18) and 6% (n = 1/16), respectively. LD and MD groups averaged 44.0 and 77.3 min per week of yoga, respectively. The MD group reported that 150 prescribed minutes per week of yoga was too much. There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups. There was a significant difference in depression scores (p = .036) and grief intensity (p = .009) between the MD and STC groups. PTSD showed non-significant decreases of 43% and 56% at post-intervention in LD and MD groups, respectively (22% decrease in control).
CONCLUSIONS
This was the first study to determine the feasibility and preliminary efficacy of an online yoga intervention for women after stillbirth. Future research warrants a randomized controlled trial.
TRIAL REGISTRATION
ClinicalTrials.gov. NCT02925481. Registered 10-04-16.",2020,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","['women after stillbirth', 'women who have experienced stillbirth', 'Participants (N\xa0=\u200990', 'stillbirth mothers']","['online yoga intervention', 'stretch and tone"" control', 'Online yoga', 'yoga or exercise (low dose (LD), 60\u2009min per week; moderate dose (MD), 150\u2009min per week; and stretch-and-tone control group (STC']","['depression scores', 'symptoms of post traumatic stress disorder (PTSD), depression, and anxiety', 'symptoms of PTSD, anxiety, depression, perinatal grief, self-compassion, emotional regulation, mindfulness, sleep quality, and subjective health', 'grief intensity', 'PTSD and depression, and improvements in self-rated health']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health Complaint'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.104793,"There were significant decreases in PTSD and depression, and improvements in self-rated health at post-intervention for both intervention groups.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'Arizona State University, Tempe, USA. Jhuberty@asu.edu.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Sullivan', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jeni', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Kurka', 'Affiliation': 'Arizona State University, Tempe, USA.'}, {'ForeName': 'Jenn', 'Initials': 'J', 'LastName': 'Leiferman', 'Affiliation': 'Colorado School of Public Health, Denver, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gold', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cacciatore', 'Affiliation': 'Arizona State University, Tempe, USA.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02926-3']
957,32686234,A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis.,"OBJECTIVES
To volumetrically compare guided bone regeneration (GBR) with connective tissue graft (CTG) to reestablish convexity at the buccal aspect of single implants.
MATERIALS AND METHODS
Patients with a single tooth gap in the anterior maxilla and horizontal alveolar defect were enrolled in a single-blind randomized clinical trial (RCT). All sites had a buccopalatal bone dimension of at least 6 mm, received a single implant, and were randomly allocated to the control (GBR) or test group (CTG) to reestablish buccal soft tissue convexity. Patients received a provisional crown at 3 months and a permanent crown at 6 months. Primary outcomes were volumetric increase (mm 3 ) and linear increase (mm) in buccal soft tissue profile (BSP) within a well-defined area of interest at fixed time points. Alveolar process deficiency was a secondary outcome.
RESULTS
Twenty-one patients were included per group (control: 11 females, mean age 51; test: 9 females, mean age 48). After 1 year, GBR resulted in a significant volumetric increase of 20.74 mm 3 (P < .001) corresponding to linear increase in BSP of 1.30 mm (P < .001). For CTG, this was 15.86 (P < .001) and 1.19 mm (P < .001), respectively. The changes over time in volume (P = .173) and BSP (P = .241) were not significantly different between the groups. Twenty-nine percentage and 26% of the final volumetric increase was the result of installing and altering prosthetic components in the control and test groups, respectively. Alveolar process deficiency significantly reduced from pre-op to 1 year following GBR (P < .001) and CTG (P < .001). The difference between the groups was not significant (P = .342). However, 58% of the patients treated with GBR and 38% treated with CTG failed to show perfect soft tissue convexity at the buccal aspect.
CONCLUSION
GBR as well as CTG are effective in reducing horizontal alveolar defects for aesthetic purposes. However, in about half of the cases, either strategy failed to optimally reestablish buccal convexity.",2020,"After 1 year, GBR resulted in a significant volumetric increase of 20.74 mm 3 (P < .001) corresponding to linear increase in BSP of 1.30 mm (P < .001).","['mean age 51; test: 9 females, mean age 48', 'Patients with a single tooth gap in the anterior maxilla and horizontal alveolar defect', 'Twenty-one patients were included per group (control: 11 females']","['guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites', 'provisional crown', 'CTG', 'guided bone regeneration (GBR) with connective tissue graft (CTG', 'control (GBR) or test group (CTG) to reestablish buccal soft tissue convexity']","['volumetric increase (mm 3 ) and linear increase (mm) in buccal soft tissue profile (BSP', 'Alveolar process deficiency', 'soft tissue convexity', 'result of installing and altering prosthetic components', 'BSP', 'changes over time in volume']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0459697', 'cui_str': 'Anterior segment of maxilla'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0053935', 'cui_str': 'Bone Sialoprotein'}, {'cui': 'C0002386', 'cui_str': 'Alveolar process'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",21.0,0.107511,"After 1 year, GBR resulted in a significant volumetric increase of 20.74 mm 3 (P < .001) corresponding to linear increase in BSP of 1.30 mm (P < .001).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'De Bruyckere', 'Affiliation': 'Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Ricardo Garcia', 'Initials': 'RG', 'LastName': 'Cabeza', 'Affiliation': 'Department of Periodontology and Oral Implantology, Faculty of Medicine and Health Sciences, Dental School, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Aryan', 'Initials': 'A', 'LastName': 'Eghbali', 'Affiliation': 'Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'Younes', 'Affiliation': 'Department of Periodontology and Oral Implantology, Faculty of Medicine and Health Sciences, Dental School, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cleymaet', 'Affiliation': 'Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Cosyn', 'Affiliation': 'Faculty of Medicine and Pharmacy, Oral Health Research Group (ORHE), Vrije Universiteit Brussel (VUB), Brussels, Belgium.'}]",Clinical implant dentistry and related research,['10.1111/cid.12934']
958,32511143,No Difference in Pain After Spine Surgery with Local Wound Filtration of Morphine and Ketorolac: A Randomized Controlled Trial.,"BACKGROUND
Controlling postoperative pain after spinal surgery is important for rehabilitation and patient satisfaction. Wound infiltration with local anesthetics may improve postoperative pain, but true multimodal approaches for achieving analgesia after spinal surgery remain unknown.
QUESTIONS/PURPOSES
In this randomized, controlled, double-blind trial after lumbar interbody fusion, we asked: (1) Does multimodal analgesia reduce VAS pain scores by a clinically important amount? (2) Does this analgesic approach reduce the amount of morphine patients consume after surgery? (3) Is this approach associated with fewer opioid-related side effects after surgery?
METHODS
This study included 80 adult patients undergoing lumbar interbody fusion who were randomized into two groups: A control group (n = 40) who received infiltration of the surgical incision at the end of the procedure with an injection of 0.5% bupivacaine 100 mg (20 mL) and epinephrine 0.5 mg (0.5 mL), and the multimodal group (n = 40), who received wound infiltration with the same approach but with different medications: 0.5% bupivacaine 92.5 mg (18.5 mL), ketorolac 30 mg (1 mL), morphine 5 mg (0.5 mL), and epinephrine 0.5 mg (0.5 mL). There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time. All treatments were administered by one surgeon. All patients, the surgeon, and the researchers were blinded to the allocation of patients to each group. Pain at rest was recorded using the VAS. Postoperative morphine consumption (administered using a patient-controlled analgesia pump) and opiod-associated side effects including nausea/vomiting, pruritus, urinary retention, and respiratory depression were assessed; this study was analyzed according to intention-to-treat principles. No loss to follow-up or protocol deviations were noted. We considered a 2-cm change on a 10-cm scale on the VAS as the minimum clinically important difference (MCID). Differences smaller than this were considered unlikely to be important.
RESULTS
At no point were there between-group differences in the VAS scores that exceeded the MCID, indicating no clinically important reductions in pain associated with administering multimodal injections. The highest treatment effect was observed at 3 hours that showed only a -1.3 cm mean difference between the multimodal and the control groups (3.2 ± 1.8 versus 4.5 ± 1.9 [95% CI -1.3 to -0.3]; p < 0.001), which was below the MCID. Morphine consumption was very slightly higher in the control group than in the multimodal group (2.8 ± 2.8 versus 0.3 ± 1.0, mean difference 2.47; p < 0.001). The percentage of patients reporting opioid-related side effects was lower in the multimodal group than in the control group. The proportions of nausea and vomiting were higher in the control group (30% [12 of 40] than in the multimodal group (3% [1 of 40]; p = 0.001). All of these side effects were transient and none was severe.
CONCLUSIONS
Multimodal wound infiltration with an NSAID and morphine did not yield any clinically important reduction in pain or opioid consumption. Since no substantial benefit of adding these drugs to a patient's aftercare regimen was achieved, and considering the potential risks of administering opioids and NSAIDs (such as, polypharmacy in older patients, serious adverse effects of NSAIDs), we recommend against routine use of this approach in clinical practice.
LEVEL OF EVIDENCE
Level I, therapeutic study.",2020,"There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time.",['80 adult patients undergoing lumbar interbody fusion who were randomized into two groups: A control group (n = 40) who received'],"['ketorolac 30 mg (1 mL), morphine', 'Morphine and Ketorolac', 'NSAID and morphine', 'local anesthetics', 'infiltration of the surgical incision at the end of the procedure with an injection of 0.5% bupivacaine', 'wound infiltration with the same approach but with different medications: 0.5% bupivacaine', 'Postoperative morphine consumption', 'epinephrine', 'morphine']","['Pain at rest', 'nausea/vomiting, pruritus, urinary retention, and respiratory depression', 'height, weight, preoperative pain score, or surgical time', 'postoperative pain', 'Pain', 'nausea and vomiting', 'Morphine consumption', 'pain', 'VAS pain scores', 'percentage of patients reporting opioid-related side effects', 'pain or opioid consumption', 'VAS scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",80.0,0.351157,"There were no between-group differences in the proportion of patients who were male, nor in the mean age, height, weight, preoperative pain score, or surgical time.","[{'ForeName': 'Weerasak', 'Initials': 'W', 'LastName': 'Singhatanadgige', 'Affiliation': 'W. Singhatanadgige, T. Chancharoenchai, C. Tanavalee, W. Limthongkul, Department of Orthopedic Surgery, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand S. Honsawek, Osteoarthritis and Musculoskeleton Research Unit, Department of Biochemistry, Faculty of Medicine, KingChulalongkorn Memorial Hospital, Thai Red Cross Society, Chulalongkorn University, Bangkok, Thailand V. Kotheeranurak, Spine Unit, Department of Orthopaedics, Queen Savang Vadhana Memorial Hospital, Sriracha, Chonburi, Thailand.'}, {'ForeName': 'Todsapon', 'Initials': 'T', 'LastName': 'Chancharoenchai', 'Affiliation': ''}, {'ForeName': 'Sittisak', 'Initials': 'S', 'LastName': 'Honsawek', 'Affiliation': ''}, {'ForeName': 'Vit', 'Initials': 'V', 'LastName': 'Kotheeranurak', 'Affiliation': ''}, {'ForeName': 'Chotetawan', 'Initials': 'C', 'LastName': 'Tanavalee', 'Affiliation': ''}, {'ForeName': 'Worawat', 'Initials': 'W', 'LastName': 'Limthongkul', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001354']
959,32515255,"Correction to: Oxygen Exposure During Cardiopulmonary Resuscitation Is Associated With Cerebral Oxidative Injury in a Randomized, Blinded, Controlled, Preclinical Trial.",,2020,,[],['Oxygen Exposure During Cardiopulmonary Resuscitation'],[],[],"[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",[],,0.130556,,[],Journal of the American Heart Association,['10.1161/JAHA.119.014549']
960,31520679,Exacerbation-prone asthma in the context of race and ancestry in Asthma Clinical Research Network trials.,"BACKGROUND
Minority groups of African descent experience disproportionately greater asthma morbidity compared with other racial groups, suggesting that genetic variation from a common ancestry could influence exacerbation risk.
OBJECTIVE
We evaluated clinical trial measures in the context of self-reported race and genetic ancestry to identify risk factors for asthma exacerbations.
METHODS
One thousand eight hundred forty multiethnic subjects from 12 Asthma Clinical Research Network and AsthmaNet trials were analyzed for incident asthma exacerbations with Poisson regression models that included clinical measures, self-reported race (black, non-Hispanic white, and other), and estimates of global genetic African ancestry in a subgroup (n = 760).
RESULTS
Twenty-four percent of 1840 subjects self-identified as black. Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV 1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects. In the combined multiethnic cohort, neither race (P = .30) nor percentage of genetic African ancestry as a continuous variable associated with exacerbation risk (adjusted rate ratio [RR], 1.26 [95% CI, 0.94-1.70; P = .13]; RR per 1-SD change [32% ancestry], 0.97 [95% CI, 0.78-1.19; P = .74]). However, in 161 black subjects with genetic data, those with African ancestry greater than the median (≥82%) had a significantly greater risk of exacerbation (RR, 3.06 [95% CI, 1.09-8.6; P = .03]).
CONCLUSION
Black subjects have unique risk factors for asthma exacerbations, of which global African genetic ancestry had the strongest effect.",2019,"Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV 1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects.","['Twenty-four percent of 1840 subjects self-identified as black', 'One thousand eight hundred forty multiethnic subjects from 12 Asthma Clinical Research Network and AsthmaNet trials were analyzed for incident asthma exacerbations with Poisson regression models that included clinical measures, self-reported race (black, non-Hispanic white, and other), and estimates of global genetic African ancestry in a subgroup (n\xa0=\xa0760', '161 black subjects with genetic data']",[],"['exacerbation risk', 'asthma morbidity', 'risk of exacerbation', 'chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0027567', 'cui_str': 'African race'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0149516', 'cui_str': 'Chronic sinusitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]",161.0,0.138303,"Black and white subjects had common risk factors for exacerbations, including a history of 2 or more exacerbations in the previous year and FEV 1 percent predicted values, whereas chronic sinusitis, allergic rhinitis, and gastroesophageal reflux disease were only associated with increased exacerbation risk in black subjects.","[{'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Grossman', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary and Critical Care, Lahey Hospital and Medical Center, Burlington, Mass.'}, {'ForeName': 'Victor E', 'Initials': 'VE', 'LastName': 'Ortega', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC. Electronic address: vortega@wakehealth.edu.'}, {'ForeName': 'Tonya S', 'Initials': 'TS', 'LastName': 'King', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University School of Medicine, Hershey, Pa.'}, {'ForeName': 'Eugene R', 'Initials': 'ER', 'LastName': 'Bleecker', 'Affiliation': 'Department of Medicine, Division of Genetics, Genomics, and Precision Medicine, University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Ampleford', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': 'Department of Pediatrics, Division of Allergy, Immunology, and Pulmonary Medicine, Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Cabana', 'Affiliation': 'Department of Pediatrics, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Cardet', 'Affiliation': 'Deparment of Internal Medicine, Divison of Allergy and Immunology, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Tara F', 'Initials': 'TF', 'LastName': 'Carr', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy, Critical Care, and Sleep Medicine, University of Arizona, Tucson, AZ.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary Diseases and Critical Care Medicine, University of Kansas, Kansas City, Kan.'}, {'ForeName': 'Loren C', 'Initials': 'LC', 'LastName': 'Denlinger', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine, Madison, Wis.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Denson', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Fandino', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Pediatrics, Emory University, Atlanta, Ga.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Hawkins', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Holguin', 'Affiliation': 'Department of Medicine, University of Colorado Anschutz Medical Campus, Denver, Colo.'}, {'ForeName': 'Jerry A', 'Initials': 'JA', 'LastName': 'Krishnan', 'Affiliation': 'Department of Medicine, University of Illinois Hospital & Health Sciences System, Chicago, Ill.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lazarus', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, Calif.'}, {'ForeName': 'Sharmilee M', 'Initials': 'SM', 'LastName': 'Nyenhuis', 'Affiliation': 'Department of Medicine, University of Illinois Hospital & Health Sciences System, Chicago, Ill.'}, {'ForeName': 'Wanda', 'Initials': 'W', 'LastName': 'Phipatanakul', 'Affiliation': ""Division of Pediatric Allergy and Immunology, Boston Children's Hospital, Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Sima K', 'Initials': 'SK', 'LastName': 'Ramratnam', 'Affiliation': 'Department of Pediatrics, University of Wisconsin School of Medicine, Madison, Wis.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Wenzel', 'Affiliation': 'Department of Environmental and Occupational Health, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pa.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Peters', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Meyers', 'Affiliation': 'Department of Medicine, Division of Genetics, Genomics, and Precision Medicine, University of Arizona College of Medicine, Tucson, Ariz.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Wechsler', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Israel', 'Affiliation': ""Division of Pulmonary and Critical Care Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.08.033']
961,31814419,Music Training Improves Depressed Mood Symptoms in Elderly People: A Randomized Controlled Trial.,"The effectiveness of music training on depressed mood and general cognitive function in elderly participants is verified in this study. Music activities consisted of improvisation exercises for stimulating interpersonal skills, mood, and cognitive functions. A mixed research method was adopted, including standardized measures (Mini-Mental State Examination and Geriatric Depression Scale) and follow-up semistructured interviews. The research design included pre- and postevaluation with randomized experimental and control groups. Participants were 45 care residents aged 62 to 95, healthy and with cognitive impairment. Results revealed a significant improvement in depression index (Geriatric Depression Scale) for the experimental period ( t = 1.450; p < .005; d = 0.453) while the control group had no improvement ( t = 0.080; p > .1; d = 0.025). In addition, a significant improvement was found in the cognitive level (Mini-Mental State Examination) for the experimental ( t = 2.300; p < .005; d = 0.668) than the control group that had a significant reduction ( t = 1.240; p < .05; d = 0.273). This study provides evidence that music training has a positive impact on depressed mood and general cognitive function in elderly participants. These types of music training sessions could provide aid to control the symptoms of depression, delay the deterioration of cognitive function, and enhance social-cognitive function, especially in individuals presenting with cognitive impairment.",2021,Results revealed a significant improvement in depression index (Geriatric Depression Scale) for the experimental period ( t = 1.450; p < .005; d = 0.453) while the control group had no improvement ( t = 0.080; p > .1; d = 0.025).,"['individuals presenting with cognitive impairment', 'Elderly People', 'elderly participants', 'Participants were 45 care residents aged 62 to 95, healthy and with cognitive impairment']","['music training sessions', 'music training', 'Music Training', 'Music activities consisted of improvisation exercises']","['standardized measures (Mini-Mental State Examination and Geriatric Depression Scale', 'stimulating interpersonal skills, mood, and cognitive functions', 'depressed mood and general cognitive function', 'cognitive level (Mini-Mental State Examination', 'depression index (Geriatric Depression Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0360057,Results revealed a significant improvement in depression index (Geriatric Depression Scale) for the experimental period ( t = 1.450; p < .005; d = 0.453) while the control group had no improvement ( t = 0.080; p > .1; d = 0.025).,"[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Biasutti', 'Affiliation': 'Department of Philosophy, Sociology, Pedagogy, and Applied Psychology, University of Padova, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mangiacotti', 'Affiliation': 'Department of Philosophy, Sociology, Pedagogy, and Applied Psychology, University of Padova, Italy.'}]",International journal of aging & human development,['10.1177/0091415019893988']
962,32520984,Effect of various exercises on frailty among older adults with subjective cognitive concerns: a randomised controlled trial.,"BACKGROUND
Physical exercise has been linked to reduced frailty, but there is insufficient evidence of beneficial effects in community-dwelling older adults with subjective cognitive concerns.
OBJECTIVE
This study aimed to clarify the effects of physical exercise in this population.
DESIGN
Single-blind randomised controlled trial.
SETTING
Community sports centres.
PARTICIPANTS
Residents aged 65-85 years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment. In total, 415 community-dwelling older adults were enrolled and randomised.
METHODS
This trial investigated the effects of aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs on reducing frailty. All participants were randomised into one of the three intervention groups or the control group. Participants in the intervention groups underwent a group training program and self-paced home training for 26 weeks. The control group received lectures about health promotion. A 95-item frailty index (FI) was utilised to determine the effects of training. Participants were followed up at weeks 26 and 52.
RESULTS
At baseline, mean age of all participants (47% women) was 72.3 ± 4.6 years, with a mean FI score of 0.3 ± 0.1. Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52. No significant differences in FI were found in RT and AT+RT groups at weeks 26 and 52.
CONCLUSIONS
A 26-week AT reduced frailty modestly, especially in the depression and anxiety component, in older adults with subjective cognitive concerns.",2020,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","['Community sports centres', 'older adults with subjective cognitive concerns', '415 community-dwelling older adults', 'Residents aged 65-85\xa0years were screened using the Kihon checklist; those with subjective cognitive concerns were invited for eligibility assessment', 'community-dwelling older adults with subjective cognitive concerns']","['various exercises', 'lectures about health promotion', 'aerobic training (AT), resistance training (RT) and combined training (AT+RT) programs', 'physical exercise', 'group training program and self-paced home training']","['FI', 'total FI', 'depression and anxiety component of FI']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",415.0,0.0634744,"Compared with control group, AT improved total FI by 0.020 (CI -0.039 to -0.001, effect size -0.275) and the depression and anxiety component of FI by 0.051 (CI -0.084 to -0.018, effect size -0.469) at week 26, but the effects waned at week 52.","[{'ForeName': 'Chi Hsien', 'Initials': 'CH', 'LastName': 'Huang', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Umegaki', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Makino', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hayashi', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Kitada', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Aiko', 'Initials': 'A', 'LastName': 'Inoue', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Shimada', 'Affiliation': 'Department of Preventive Gerontology, Center for Gerontology and Social Science, National Center for Geriatrics and Gerontology, Obu City, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Age and ageing,['10.1093/ageing/afaa086']
963,32510644,Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate for root coverage: 2-year results of an RCT using 3D digital measuring for volumetric comparison of gingival dimensions.,"AIM
The aim of this randomized clinical trial was to compare clinical and volumetric outcomes of tunnel technique (TUN) with subepithelial connective tissue graft (CTG) versus coronally advanced flap (CAF) with enamel matrix derivate (EMD) 2 years after gingival recession (GR) treatment.
MATERIALS AND METHODS
Twenty-three patients contributed 45 Miller class I or II GR. At baseline and follow-up examinations, study models were collected. Their three-dimensional scans allowed precise computer-assisted measurement of recession depth (REC), complete root coverage (CRC), percentage of root coverage (RC), pointwise (pTHK) and mean areal (aTHK) marginal soft tissue thickness. Clinical examination delivered probing depths (PPD) and height of keratinized tissue.
RESULTS
24 months after surgery, digitally evaluated CRC was present in 60.0% of the TUN + CTG and 0.0% of the CAF + EMD-treated sites (p < .0001), meaning a certain relapse of the gingival margin ragarding both approaches. RC amounted to 94.0% (TUN + CTG) and 57.3% (CAF + EMD), respectively (p < .0001). REC reduction (RECred) was significantly higher for TUN + CTG (1.81 ± 0.56 mm) than for CAF + EMD (0.90 ± 0.45 mm) (p < .0001). pTHK and aTHK values were significantly greater in the TUN + CTG group (1.41 ± 0.35 mm and 1.11 ± 0.26 mm) than in the CAF + EMD group (0.78 ± 0.32 mm and 0.60 ± 0.26 mm) (p < .0001). Statistical analysis detected positive correlations between THK and both RC and RECred (p < .001).
CONCLUSIONS
Two years post-operatively, CTG showed better clinical and volumetric outcomes than EMD. Increased THK values were associated with improved outcomes regarding RC and RECred.",2020,REC reduction (RECred) was significantly higher for TUN+CTG (1.81±0.56mm) than for CAF+EMD (0.90±0.45mm) (p<0.0001).,['23 patients contributed 45 Miller class I or II GR'],"['TUN+CTG', 'Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate', 'tunnel technique (TUN) with subepithelial connective tissue graft (CTG) versus coronally advanced flap (CAF) with enamel matrix derivate (EMD']","['REC reduction (RECred', 'Clinical examination delivered probing depths (PPD) and height of keratinized tissue (HKT', 'RC', 'recession depth (REC), complete root coverage (CRC), percentage of root coverage (RC), pointwise (pTHK) and mean areal (aTHK) marginal soft tissue thickness', 'pTHK and aTHK values', 'Increased THK values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}]","[{'cui': 'C0080232', 'cui_str': 'Transplantation, Tissue'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]","[{'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2606415', 'cui_str': 'ZDHHC2 protein, human'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0465349,REC reduction (RECred) was significantly higher for TUN+CTG (1.81±0.56mm) than for CAF+EMD (0.90±0.45mm) (p<0.0001).,"[{'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Zuhr', 'Affiliation': 'Private Practice Hürzeler/Zuhr, Munich, Germany.'}, {'ForeName': 'Stephan F', 'Initials': 'SF', 'LastName': 'Rebele', 'Affiliation': 'Private Practice Rebele, Dinkelsbühl, Germany.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Vach', 'Affiliation': 'Faculty of Medicine and Medical Center, Institute of Medical Biometry and Statistics, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Petsos', 'Affiliation': 'Department of Periodontology, Center of Dentistry and Oral Medicine (Carolinum), Johann Wolfgang Goethe-University, Frankfurt/Main, Germany.'}, {'ForeName': 'Markus B', 'Initials': 'MB', 'LastName': 'Hürzeler', 'Affiliation': 'Private Practice Hürzeler/Zuhr, Munich, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical periodontology,['10.1111/jcpe.13328']
964,32510696,"Biomarkers of oxidative stress and inflammation in people witha physical disability treated with a standardized extract of Nasturtium officinale: A randomized, double-blind, and placebo-controlled trial.","It is well established that plants from the Brassicaceae family, particularly watercress, have been associated to reduce oxidative DNA damage. Nasturtium officinale R. Br (watercress) contains glucosinolates, with anti-inflammatory action and protective effect on human health against oxidative stress. We aimed to evaluate whether the standardized extract of Nasturtium officinale (SENO) is capable of changing biomarkers of oxidative stress and inflammation in people with physical disabilities. 65 people enrolled this study: as a control group composed by; 15 people with no physical disability assessed once, 25 people with physical disabilities using 750 mg/kg/day of SENO, and 25 people with physical disabilities using 750 mg/kg/day of placebo-control for 5 weeks. Biomarkers of oxidative stress and inflammation were analyzed on day 0 and 36. The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein. Furthermore, the cytokine kit demonstrated below and out of invertible range, which was impossible to detect the inflammatory process. Despite the cytokine kit was not able to detect the inflammation; these data might provide supportive evidence that SENO, have affected positively people with physical disabilities decreasing their biomarkers of oxidative stress and C-reactive protein. Further studies are required.",2020,"The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein.","['people witha physical disability treated with a standardized extract of Nasturtium officinale', 'people with physical disabilities', '65 people enrolled this study: as a control group composed by; 15 people with no physical disability assessed once, 25 people with physical disabilities using 750\u2009mg/kg/day of SENO, and 25 people with physical disabilities using 750\u2009mg/kg/day of']","['SENO', 'standardized extract of Nasturtium officinale (SENO', 'placebo-control for 5\u2009weeks', 'placebo']","['levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453151', 'cui_str': 'Watercress'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0453151', 'cui_str': 'Watercress'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",65.0,0.179116,"The results indicated that SENO was associated with decreasing levels of lipid peroxidation, protein carbonyl, catalase, superoxide dismutase, and C-reactive protein.","[{'ForeName': 'Mirna', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Marilis D', 'Initials': 'MD', 'LastName': 'Miguel', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Karina B', 'Initials': 'KB', 'LastName': 'Felipe', 'Affiliation': 'Department of Biochemistry, Federal University of Parana, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gribner', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'F Moura', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Ana Angelica', 'Initials': 'AA', 'LastName': 'R Rigoni', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'B Parisotto', 'Affiliation': 'School of Pharmaceutical Sciences, Food and Nutrition, Federal University of Mato Grosso do Sul, Brazil.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'T Piltz', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Glaucio', 'Initials': 'G', 'LastName': 'Valdameri', 'Affiliation': 'Clinical Analysis Department, Federal University of Parana, Brazil.'}, {'ForeName': 'Railson', 'Initials': 'R', 'LastName': 'Henneberg', 'Affiliation': 'Clinical Analysis Department, Federal University of Parana, Brazil.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'B Schonhofen', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'João Luiz', 'Initials': 'JL', 'LastName': 'S Carvalho', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}, {'ForeName': 'Luiz Claudio', 'Initials': 'LC', 'LastName': 'Fernandes', 'Affiliation': 'Department of Physiology, Federal University of Parana, Brazil.'}, {'ForeName': 'Obdúlio', 'Initials': 'O', 'LastName': 'G Miguel', 'Affiliation': 'Department of Pharmaceutical Sciences, Federal University of Parana, Brazil.'}]",Phytotherapy research : PTR,['10.1002/ptr.6718']
965,32510734,"Azithromycin and COVID-19: Prompt early use at first signs of this infection in adults and children, an approach worthy of consideration.","The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19. Initial enthusiasm for the combination of hydroxychloroquine and azithromycin has abated. However, as a result of positive clinical experience with azithromycin used alone during the first few days of the flu-like illness caused by this coronavirus, we recommend formal clinical trials using azithromycin early in the course of a COVID-19 infection. There is one clinical trial initiated, the individually randomized, telemedicine-based, ""Azithromycin for COVID-19 Treatment in Outpatients Nationwide"" based at the University of California San Francisco. This placebo-controlled trial is designed to determine the efficacy of a single 1.2-g dose of oral azithromycin to prevent COVID-19 patient progression to hospitalization. We recommend formal clinical trials of azithromycin in its prepackaged form at the first sign of COVID-19 infection in adults and children, using an initial adult dose of 500 mg followed by 250 mg per day for 4 days, a total cumulative dose of 1.5 g, and for children 5 to 18 years of age, 10 mg/kg on the first day followed by 5 mg/kg for 4 days.",2020,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"['Adults and Children', 'Outpatients Nationwide (ACTION)"" based at the University of California San Francisco', 'adults and children']","['hydroxychloroquine and azithromycin', 'telemedicine-based, ""Azithromycin', 'Azithromycin', 'azithromycin', 'placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0479328,The devastating effects of the coronavirus designated severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2) has led to urgent attempts to find effective therapeutic agents for inpatient and outpatient treatment of COVID-19.,"[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schwartz', 'Affiliation': 'Professor of Dermatology and Pathology, Rutgers University New Jersey Medical School, Newark, New Jersy, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Suskind', 'Affiliation': 'Professor of Pediatrics and Founding Dean Emeritus, California University of Science of Medicine, San Bernardino, California, USA.'}]",Dermatologic therapy,['10.1111/dth.13785']
966,32515543,Lower risk of severe hypoglycaemia with insulin glargine 300 U/mL versus glargine 100 U/mL in participants with type 1 diabetes: A meta-analysis of 6-month phase 3 clinical trials.,"Severe hypoglycaemia (SH) remains a challenge to people with type 1 diabetes (T1DM), and new-generation basal insulins may improve patient outcomes. This post hoc meta-analysis explored the risk of SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL (Gla-100) in a pooled population with T1DM from three randomized, multicentre, 6-month similarly designed phase 3 trials: EDITION 4, EDITION JP 1 and EDITION JUNIOR. Endpoints included incidence and time to first occurrence of SH. Among 629 and 626 participants randomized to Gla-300 and Gla-100, respectively, glycated haemoglobin reductions were similar. Fewer participants experienced ≥1 SH event with Gla-300 (6.2%) than with Gla-100 (9.3%). From baseline to month 6, the risk of a first SH event was lower with Gla-300: hazard ratio 0.65 [95% confidence interval (CI) 0.44-0.98; stratified log-rank test P = 0.038]. SH event rates were numerically lower with Gla-300 versus Gla-100 from baseline to month 6 [relative risk (RR) 0.80 (95% CI 0.49-1.29); P = 0.356] and baseline to week 8 [RR 0.73 (95% CI 0.37-1.44); P = 0.369]. Thus, Gla-300 demonstrated similar glycaemic control with lower risk of SH versus Gla-100, particularly during the titration period.",2020,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,['Participants with Type 1 Diabetes'],"['Glargine 100', 'SH with insulin glargine 300 U/mL (Gla-300) versus glargine 100 U/mL', 'Insulin Glargine']","['incidence and time to first occurrence of SH', 'Severe hypoglycaemia (SH', '≥1 SH event with Gla-300', 'risk of a first SH event', 'SH event rates']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439340', 'cui_str': 'kU/L'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0663423,SH event rates (relative risk [95% CI]) were numerically lower with Gla-300 versus Gla-100 from baseline to Month 6 (0.80 [0.49-1.29; P = 0.356]) and baseline to Week 8 (0.73 [0.37-1.44; P = 0.369]).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital Auf der Bult, Hannover Medical School, Hannover, Germany.""}, {'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Center, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sussebach', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Harmonie', 'Initials': 'H', 'LastName': 'Goyeau', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lauand', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi, Frankfurt am Main, Germany.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14109']
967,32516494,The Impact of Treatment Description Format on Patient Preferences for Posttraumatic Stress Disorder Treatment.,"The present study examined how the format in which treatment information is presented impacts individuals' preferences for posttraumatic stress disorder (PTSD) treatments. Adults who screened positive for PTSD (N = 301) were randomized into groups to learn about five first-line treatments; participants either read sequential text descriptions or reviewed a comparison chart that presented side-by-side information. Participants rated treatment acceptability, rank ordered treatments from most to least preferred, and indicated their confidence in this ranking. Compared with participants in the text group, those in the chart group assigned more favorable acceptability ratings to prolonged exposure therapy (PE) and more moderate ratings to medications. Cognitive processing therapy was the most common first-choice treatment (43.6%). Forced-choice treatment rankings were similar across conditions, although participants in the chart group ranked PE more favorably than those in the text group, odds ratio (OR) = 0.54, 95% CI [0.35, 0.82], p = .004. Confidence in treatment rankings did not differ across conditions. The results suggest that perceptions of treatment acceptability can be influenced by the format in which treatment information is presented. In settings where the goal is to increase treatment acceptability, side-by-side formats may offer an advantage over sequential descriptions of each treatment.",2020,Confidence in treatment rankings did not differ across conditions.,"['Patient Preferences for Posttraumatic Stress Disorder Treatment', 'Adults who screened positive for PTSD (N = 301']","['learn about five first-line treatments; participants either read sequential text descriptions or reviewed a comparison chart that presented side-by-side information', 'Cognitive processing therapy']",['favorable acceptability ratings'],"[{'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",301.0,0.0278761,Confidence in treatment rankings did not differ across conditions.,"[{'ForeName': 'Juliette M', 'Initials': 'JM', 'LastName': 'Harik', 'Affiliation': 'National Center for PTSD-Executive Division, White River Junction, Vermont, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Grubbs', 'Affiliation': 'Veterans Affairs San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Hamblen', 'Affiliation': 'National Center for PTSD-Executive Division, White River Junction, Vermont, USA.'}]",Journal of traumatic stress,['10.1002/jts.22528']
968,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE
Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended.
METHOD
To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website.
RESULTS
Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
CONCLUSION
Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001).
","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177']
969,32503948,Early tumor shrinkage identifies long-term disease control and survival in patients with lung cancer treated with atezolizumab.,"BACKGROUND
Preliminary evidence indicates that early tumor shrinkage (ETS) following immune checkpoint inhibitor (ICI) initiation may be associated with survival outcomes in patients with advanced melanoma. ETS has not been explored as a biomarker of survival outcomes or patient-reported outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs.
METHODS
The study pooled data from patients with NSCLC in the randomized trials OAK and POPLAR (atezolizumab vs docetaxel; n=1464), and single-arm atezolizumab trials BIRCH and FIR (n=797). The association between ETS (≥10% decrease in pretreatment sum-of-longest diameters of target-lesions at 6 weeks) and overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF) was assessed using Cox proportional hazard analysis.
RESULTS
ETS occurred in 20% of atezolizumab-treated patients with NSCLC within OAK and POPLAR and was associated with highly favorable OS (HR 0.33, p<0.001), PFS (HR 0.31, p<0.001), TDD in HRQoL (HR 0.73, p=0.01) and PF (HR 0.52, p<0.001). The results were replicated in the BIRCH and FIR data. Atezolizumab-treated patients achieving ETS had markedly improved OS compared with docetaxel-treated patients achieving ETS (24-month OS 55% vs 32%); PFS was also markedly improved (24-month PFS 31% vs 4%). In contrast, for patients not achieving ETS, atezolizumab-treatment was associated with more modest OS (24-month OS 23% vs 20%) and PFS (24-month PFS 3% vs 1%) improvement compared with docetaxel. Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
CONCLUSIONS
ETS is an easily measurable biomarker, predictive of highly favorable survival and patient-reported outcomes with atezolizumab treatment for advanced NSCLC. Further, ETS identifies patients with significantly greater treatment benefit for ICI therapy.",2020,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
","['patients with advanced melanoma', 'patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs', 'patients with lung cancer treated with', 'patients with NSCLC']","['atezolizumab', 'POPLAR (atezolizumab vs docetaxel', 'docetaxel', 'Atezolizumab-treated patients achieving ETS']","['modest OS', 'PFS', 'OS', 'effect size for ETS', 'overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF', 'TDD in HRQoL', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0183841', 'cui_str': 'TDD'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.160724,"Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Hopkins', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia ashley.hopkins@flinders.edu.au.'}, {'ForeName': 'Ganessan', 'Initials': 'G', 'LastName': 'Kichenadasse', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Chris S', 'Initials': 'CS', 'LastName': 'Karapetis', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Rowland', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sorich', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2019-000500']
970,32510754,Effect of Nigella sativa oil supplement on risk factors for cardiovascular diseases in patients with type 2 diabetes mellitus.,"This study aimed to evaluate the effects of Nigella sativa oil on serum level of systemic inflammation, oxidative stress, fasting blood glucose (FBG), and lipid profile in patients with type 2 diabetes mellitus (T2DM). This double-blind randomized clinical trial study was based on 50 patients with T2DM. Patients were allocated randomly to either N. sativa oil or placebo groups. The intervention group received 1,000 mg N. sativa oil as two capsules, daily for 8 weeks, whereas the placebo group received a corresponding placebo. At baseline and the end of the study, 5 ml blood was collected from each patient after 14-hour fasting for measuring serum C-reactive protein (hs-CRP), malondialdehyde (MDA), FBS, and lipid profile. Analyses covariance was performed to compare investigated parameters between two groups, controlled for relevant covariates. Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group. Nigella sativa oil supplement has cardiovascular protective effects in patients with T2DM, by improving the lipid profile and glycemia, by reducing the C-reactive protein level and the lipid peroxidation.",2020,"Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group.","['patients with T2DM', 'patients with type 2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM', '50 patients with T2DM']","['1,000\u2009mg N. sativa oil', 'Nigella sativa oil', 'Nigella sativa oil supplement', 'sativa oil or placebo', 'placebo']","['total cholesterol', 'serum C-reactive protein (hs-CRP), malondialdehyde (MDA), FBS, and lipid profile', 'low-density lipoprotein cholesterol', 'serum hs-CRP, MDA', 'triglyceride', 'serum level of systemic inflammation, oxidative stress, fasting blood glucose (FBG), and lipid profile', 'cardiovascular protective effects', 'FBS', 'serum level of high-density lipoprotein cholesterol', 'risk factors for cardiovascular diseases']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C3651714', 'cui_str': 'NIGELLA SATIVA SEED OIL'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]",50.0,0.281672,"Using N. sativa supplement was significantly associated with decrease in FBS (p < .001), triglyceride (p < .001), total cholesterol (p < .001), low-density lipoprotein cholesterol (p < .001), serum hs-CRP, MDA (p < .001) and increase in serum level of high-density lipoprotein cholesterol (p < .001) in intervention group compared with placebo group.","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Kooshki', 'Affiliation': 'Non-Communicable Diseases Research Center, Department of Nutrition & Biochemistry, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Tofighiyan', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Rastgoo', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Rakhshani', 'Affiliation': 'Iranian Research Center on Healthy Aging, Department of Biostatistics and Epidemiology, School of Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Miri', 'Affiliation': 'Non-Communicable Diseases Research Center, Department of Environmental Health, School of Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6707']
971,32512234,Oxygen supplementation increases the total work and muscle damage markers but reduces the inflammatory response in COPD patients.,"INTRODUCTION
Oxygen supplementation (O 2 -Suppl) is recommended for pulmonary rehabilitation with higher exercise intensities. However, high-intensity exercise tends toward muscle damage and a greater inflammatory response. We aimed to investigate the effect of O 2 -Suppl during exercise test (EET) on CRP level and muscle damage (CPK, LDH, lactate) in non-hypoxemic COPD patients.
METHODS
Eleven non-depleted patients with COPD (FEV 1 65.5 ± 4.3 %) performed two EET (room-air or O 2 -Suppl-100 %), through a blind, randomized, and placebo-controlled crossover design. CPK, LDH and CRP were measured before, immediately after and 24 h after EET.
RESULTS
Exercise time was higher with O 2 -Suppl (49.9 ± 37.3 %; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L). The O 2 -Suppl protocol resulted in a lower increase in CRP (92.1 ± 112.4 % vs. 400.1 ± 384.9 %; p = 0.003).
CONCLUSIONS
O 2 -Suppl increases exercise-tolerance, resulting in increased muscle injury markers in COPD. However, oxygen supplementation attenuates the inflammatory response, even upon increased physical exercise.",2020,"RESULTS
Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","['Eleven non-depleted patients with COPD (FEV 1 65.5\u2009±\u20094.3%) performed two EET (room-air or O 2 -Suppl-100', 'COPD patients', 'non-hypoxemic COPD patients']","['oxygen supplementation', 'Oxygen supplementation (O 2 -Suppl', 'O 2 -Suppl during exercise test (EET', 'Oxygen supplementation', 'placebo']","['Exercise time', 'CRP', 'CPK and LDH', 'CPK, LDH and CRP', 'total work and muscle damage markers', 'physical exercise', 'exercise-tolerance', 'CRP level and muscle damage (CPK, LDH, lactate', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",11.0,0.185322,"RESULTS
Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","[{'ForeName': 'Daniela Rodrigues', 'Initials': 'DR', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Kelly Critine', 'Initials': 'KC', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Julia Sampel', 'Initials': 'JS', 'LastName': 'de Castro', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Viviani Aparecida', 'Initials': 'VA', 'LastName': 'Lara', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'de Luca', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil.'}, {'ForeName': 'Mayron F', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; VO2Care Research Group, Research Physiotherapy Coordinator of Vila Nova Star Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Wladimir Musetti', 'Initials': 'WM', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil; Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil; Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; HEART - Institute of Cardiology, Department of Education and Research, São Paulo, Brazil. Electronic address: wmusettimedeiros@hotmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103475']
972,32515738,Bioresorbable scaffolds versus everolimus-eluting metallic stents: five-year clinical outcomes of the randomised ABSORB II trial.,,2020,,[],['everolimus-eluting metallic stents'],[],[],"[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}]",[],,0.0641064,,"[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': ''}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': ''}, {'ForeName': 'Àngel', 'Initials': 'À', 'LastName': 'Cequier', 'Affiliation': ''}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haude', 'Affiliation': ''}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrié', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Rapoza', 'Affiliation': ''}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Reith', 'Affiliation': ''}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'de Sousa Almeida', 'Affiliation': ''}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': ''}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Íñiguez-Romo', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00024']
973,32517492,Intraoperative Effect of 2D vs 3D Fluoroscopy on Quality of Reduction and Patient-Related Outcome in Calcaneal Fracture Surgery.,"BACKGROUND
Three-dimensional (3D) fluoroscopy is thought to be advantageous in the open reduction and internal fixation (ORIF) of calcaneal fractures. The goal of this multicenter randomized controlled trial was to investigate the clinical effect of additional intraoperative 3D fluoroscopy on postoperative quality of reduction and fixation and patient-reported outcome as compared to conventional 2-dimensional (2D) fluoroscopy in patients with intra-articular fractures of the calcaneus.
METHODS
Patients were randomized to 3D or conventional 2D fluoroscopy during operative treatment of calcaneal fractures. Primary outcome was the difference in quality of fracture reduction and implant position on postoperative computed tomography (CT). Secondary endpoints included intraoperative corrections (prior to wound closure), complications, and revision surgery (after wound closure). Function and patient-reported outcome were evaluated after surgery and included range of motion, Foot and Ankle Outcome Score (FAOS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Short-Form 36 (SF-36) questionnaires, and Kellgren-Lawrence posttraumatic osteoarthritis classification. A total of 102 calcaneal fractures were included in the study in 100 patients. Fifty fractures were randomized to the 3D group and 52 to the 2D group.
RESULTS
There was a statistically significant difference in duration of surgery between the groups (2D 125 min vs 3D 147 min; P < .001). After 3D fluoroscopy, a total of 57 intraoperative corrections were performed in 28 patients (56%). The postoperative CT scan revealed an indication for additional revision of reduction or implant position in 69% of the 3D group vs 60% in the 2D fluoroscopy group. At 2 years, there was no difference in number of revision surgery, complications, FAOS, AOFAS score, SF-36 score, or posttraumatic osteoarthritis.
CONCLUSION
The use of intraoperative 3D fluoroscopy in the treatment of intra-articular calcaneal fractures prolongs the operative procedures without improving the quality of reduction and fixation. There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis. Level of Evidence: Level I, prospective randomized controlled study.",2020,"There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis. ","['patients with intra-articular fractures of the calcaneus', 'Calcaneal Fracture Surgery', '102 calcaneal fractures were included in the study in 100 patients', 'Fifty fractures were randomized to the 3D group and 52 to the 2D group', 'Patients']","['conventional 2-dimensional (2D) fluoroscopy', 'conventional 2D fluoroscopy', 'intraoperative 3D fluoroscopy', '2D vs 3D Fluoroscopy', 'additional intraoperative 3D fluoroscopy']","['postoperative CT scan', 'number of revision surgery, complications, FAOS, AOFAS score, SF-36 score, or posttraumatic osteoarthritis', 'postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis', 'additional revision of reduction or implant position', 'duration of surgery', 'quality of fracture reduction and implant position on postoperative computed tomography (CT', 'quality of reduction and fixation', 'range of motion, Foot and Ankle Outcome Score (FAOS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Short-Form 36 (SF-36) questionnaires, and Kellgren-Lawrence posttraumatic osteoarthritis classification', 'intraoperative 3D fluoroscopy', 'Quality of Reduction and Patient-Related Outcome', 'intraoperative corrections (prior to wound closure), complications, and revision surgery (after wound closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332715', 'cui_str': 'Fracture, intra-articular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]",50.0,0.0919927,"There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis. ","[{'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Halm', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'M Suzan H', 'Initials': 'MSH', 'LastName': 'Beerekamp', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'de Muinck-Keijzer', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maas', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schepers', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}]",Foot & ankle international,['10.1177/1071100720926111']
974,32524605,An integrated approach to improve maternal and perinatal outcomes in rural Guatemala: A stepped-wedge cluster randomized trial.,"OBJECTIVE
To evaluate the impact of an intervention package on maternal and newborn health indicators.
METHODS
A randomized stepped-wedge non-blind trial was conducted across six subdistricts within two districts in Guatemala from January 2014 to January 2017. Data on outcomes were collected on all deliveries in all 33 health centers. The intervention package included distribution of promotional materials encouraging health center delivery; education for traditional birth attendants about the importance of health center delivery; and provider capacity building using simulation training. Main outcomes were number of health center deliveries, maternal morbidity, and perinatal morbidity and mortality.
RESULTS
Overall, there were 24 412 deliveries. Health center deliveries per 1000 live births showed an overall increase, although after adjustment for secular trends and clustering, the relative risk for the treatment effect was not statistically significant (aRR, 1.04; 95% confidence interval [CI], 0.97-1.11, P=0.242). Although not statistically significant, maternal morbidity (aRR, 0.78; 95% CI, 0.60-1.02; P=0.068) and perinatal morbidity (aRR, 0.84; 95% CI, 0.68-1.05; P=0.133) showed a tendency toward a decrease.
CONCLUSION
The present study represents one of the few randomized evaluations of an integrated approach to improve birth outcomes in a low-income setting. ClinicalTrials.gov: NCT0315107.",2020,"Although not statistically significant, maternal morbidity (aRR, 0.78; 95% CI, 0.60-1.02; P=0.068) and perinatal morbidity (aRR, 0.84; 95% CI, 0.68-1.05; P=0.133) showed a tendency toward a decrease.","['six subdistricts within two districts in Guatemala from January 2014 to January 2017', 'rural Guatemala']","['promotional materials encouraging health center delivery; education for traditional birth attendants about the importance of health center delivery; and provider capacity building using simulation training', 'intervention package']","['maternal morbidity', 'perinatal morbidity', 'birth outcomes', 'number of health center deliveries, maternal morbidity, and perinatal morbidity and mortality']","[{'cui': 'C0018367', 'cui_str': 'Guatemala'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0040600', 'cui_str': 'Traditional Birth Attendant'}, {'cui': 'C2718026', 'cui_str': 'Capacity Building'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",24412.0,0.143651,"Although not statistically significant, maternal morbidity (aRR, 0.78; 95% CI, 0.60-1.02; P=0.068) and perinatal morbidity (aRR, 0.84; 95% CI, 0.68-1.05; P=0.133) showed a tendency toward a decrease.","[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Kestler', 'Affiliation': 'Epidemiological Research Center in Sexual and Reproductive Health, Guatemala City, Guatemala.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Ambrosio', 'Affiliation': 'Epidemiological Research Center in Sexual and Reproductive Health, Guatemala City, Guatemala.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Matute', 'Affiliation': 'Centro de Investigaciones en Nutrición y Salud, Guatemala City, Guatemala.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Moreno', 'Affiliation': 'USAID, Guatemala Monitoring and Evaluation Program, Guatemala City, Guatemala.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Madriz', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Dilys', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'University of California, San Francisco, CA, USA.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13262']
975,32510111,Effects of Health Risk Assessment and Counselling on Fruit and Vegetable Intake in Older People: A Pragmatic Randomised Controlled Trial.,"OBJECTIVES
Interventions to increase fruit and vegetable intake among community-dwelling older people have shown mixed effects. We investigated whether an intervention based on an initial multidimensional health risk assessment and subsequent physician-lead nutrition counselling has favourable effects on dietary intake among community-dwelling older people.
DESIGN
Randomised controlled trial comparing the intervention versus usual care.
SETTING AND PARTICIPANTS
Non-disabled persons aged 65 years or older at an ambulatory geriatric clinic in Bucharest, Romania, allocated to intervention (n=100) and control (n=100) groups.
INTERVENTION
Participants received a computer-generated health profile report based on answers to a health risk assessment questionnaire, followed by monthly individual counselling sessions with a geriatrician on topics related to health promotion and disease prevention, with a special focus on adequate fruit and vegetable consumption.
MEASUREMENTS
Fruit and vegetable intake at baseline and at 6-month follow-up.
RESULTS
At baseline, fruit and vegetable intake was below the recommended five portions per day in most study participants (85% in the intervention group, and 86% among controls, respectively). At six months, intake increased in the intervention group from a median of 3.8 to 4.6 portions per day, and decreased in the control group due to a seasonal effect from a median of 3.8 to 3.1 portions per day. At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls (median difference 1.4 portions per day, 95% confidence interval 1.1-1.7, p<0.001).
CONCLUSION
Personalised food-based dietary guidance, delivered as part of multidimensional preventive health counselling during geriatric clinic visits, results in relevant improvement of fruit and vegetable intake in community-dwelling older adults.",2020,"At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls","['Non-disabled persons aged 65 years or older at an ambulatory geriatric clinic in Bucharest, Romania, allocated to intervention (n=100) and control (n=100) groups', 'community-dwelling older adults', 'community-dwelling older people', 'Older People']","['Health Risk Assessment and Counselling on Fruit and Vegetable Intake', 'computer-generated health profile report based on answers to a health risk assessment questionnaire, followed by monthly individual counselling sessions with a geriatrician on topics related to health promotion and disease prevention, with a special focus on adequate fruit and vegetable consumption', 'initial multidimensional health risk assessment and subsequent physician-lead nutrition counselling']","['Fruit and vegetable intake', 'fruit and vegetable consumption', 'fruit and vegetable intake']","[{'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0555968', 'cui_str': 'Elderly assessment clinic'}, {'cui': 'C0035826', 'cui_str': 'Romania'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0679809', 'cui_str': 'Health Risk Assessment'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0586872', 'cui_str': 'Geriatrics specialist'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3714365', 'cui_str': 'Nutrition counseling'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0373016,"At six months, fruit and vegetable consumption was significantly higher among persons in the intervention group as compared to controls","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Herghelegiu', 'Affiliation': 'Andreas Ernst Stuck, Department of Geriatrics, Inselspital, University Hospital Bern, and University of Bern, Bern, Switzerland, andreas.stuck@insel.ch.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Wenzel', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moser', 'Affiliation': ''}, {'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Prada', 'Affiliation': ''}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Nuta', 'Affiliation': ''}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Stuck', 'Affiliation': ''}]","The journal of nutrition, health & aging",['10.1007/s12603-020-1373-9']
976,31221047,"Telecare management of pain and mood symptoms: Adherence, utility, and patient satisfaction.","INTRODUCTION
Pain, depression, and anxiety are prominent symptoms that frequently co-occur, causing significant debilitation and frequent primary care visits. This paper examines the acceptability of telecare and self-management modules in managing these conditions in a randomized trial.
METHODS
The Comprehensive Management of Mood and Physical Symptoms (CAMMPS) trial compared an automated symptom management (ASM) plus self-management intervention with a comprehensive symptom management (CSM) intervention that added telecare facilitation of enhanced services. Data from the CAMMPS trial were analysed to compare the acceptability of these two interventions as indicated by utilization and patient satisfaction surveys.
RESULTS
The mean number of automated reports completed was similar between the CSM and ASM groups (14.5 vs 14.0). Responses designated with clinically relevant ""red alerts"" (i.e. patient reports warranting an expedited nurse contact) were more frequent in the CSM group (10.2 vs 8.3). The CSM and ASM groups completed a similar number of the nine self-management modules (6.3 vs 5.8). The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5; p = .003). The most common feedback suggestion from the ASM group was to have more personal interaction, while participants from both groups commonly suggested technical improvements or requests for more flexible timing of calls.
DISCUSSION
Participants generally found both interventions satisfactory, with a trend in satisfaction data suggesting that patients tended to find the CSM intervention more helpful.",2020,The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5; p = .003).,[],"['automated symptom management (ASM) plus self-management intervention with a comprehensive symptom management (CSM) intervention', 'CSM intervention', 'ASM']","['mean number of automated reports completed', 'mean helpfulness score']",[],"[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0507187,The mean helpfulness score across all modules was higher in the CSM group than in the ASM group (1.8 vs 1.5; p = .003).,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bushey', 'Affiliation': 'Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Kroenke', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Weiner', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Porter', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Evans', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}, {'ForeName': 'Fitsum', 'Initials': 'F', 'LastName': 'Baye', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Lourens', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indianapolis, IN, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Weitlauf', 'Affiliation': 'VA HSR&D Center for Health Information and Communication, Roudebush VA Medical Center, Indianapolis, IN, USA.'}]",Journal of telemedicine and telecare,['10.1177/1357633X19856156']
977,32511803,Improving Outcomes Among Young Adults with type 1 diabetes: The D1 Now Randomised Pilot Study Protocol.,"BACKGROUND
Young adults (18-25 years old) living with type 1 diabetes mellitus often have sub-optimal glycaemic levels which can increase their risk of long term diabetes complications. Informed by health psychology theory and using a (public and patient involvement) young adult-centred approach, we have developed a complex intervention, entitled D1 Now, to improve outcomes in this target group. The D1 Now intervention includes three components; 1) a support-worker, 2) an interactive messaging system and 3) an agenda setting tool for use during clinic consultations.
AIMS
The aim of the D1 Now pilot study is to gather and analyse acceptability and feasibility data to allow us to (1) refine the D1 Now intervention, and (2) determine the feasibility of a definitive Randomised Control Trial (RCT) of the intervention.
METHODS
Diabetes clinics on the island of Ireland will be recruited and randomised to a D1 Now intervention arm or a usual care control arm. For a participant to be eligible they should be 18-25 years old and living with type 1 diabetes for at least 12 months. Participant outcomes (influenced by a Core Outcome Set) include change in HbA1c, clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes; these will be will be measured at baseline and after 12 months follow-up for descriptive statistics only. An assessment of treatment fidelity, a health economic analysis and a qualitative sub-study will also be incorporated into the pilot study. ISRCTN (ref: ISRCTN74114336).",2020,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations.
","['Young adults (aged 18-25 years) living with type 1 diabetes mellitus', 'young adults with type 1 diabetes', 'Diabetes clinics on the island of Ireland will be recruited and randomized to a D1', 'aged 18-25 years and living with type 1 diabetes for at least 12 months']",[],"['change in HbA 1c , clinic attendance, number of episodes of severe hypoglycaemia and of diabetic ketoacidosis, diabetes distress, self-management, quality of life and perceived level of control over diabetes']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.094398,"The D1 Now intervention has three components: (1) a support worker; 2) an interactive messaging system; and 3) an agenda-setting tool for use during clinic consultations.
","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Casey', 'Affiliation': 'Physical Activity for Health Cluster, Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Casey', 'Affiliation': 'School of Nursing & Midwifery, NUI Galway, Galway, Ireland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gillespie', 'Affiliation': 'Health Economics & Policy Analysis Centre, Centre for Research in Medical Devices, NUI Galway, Galway, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hobbins', 'Affiliation': 'Centre for Research in Medical Devices (Cúram) and Health Economics and Policy Analysis Centre (HEPAC), NUI Galway, Galway, Ireland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Newell', 'Affiliation': 'School of Mathematics, Statistics & Applied Mathematics, NUI Galway, Galway, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Morrissey', 'Affiliation': 'Health Behaviour Change Research Group, School of Psychology, NUI Galway, Galway, Ireland.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Dinneen', 'Affiliation': 'School of Medicine, NUI Galway, Galway, Ireland.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14337']
978,32516769,Amount of Dentifrice and Fluoride Concentration Influence Salivary Fluoride Concentrations and Fluoride Intake by Toddlers.,"The present study evaluated fluoride (F) concentrations in saliva of toddlers after brushing with dentifrices containing different F concentrations, applied in different quantities, and estimated F intake from toothbrushing. The study comprised a double-blind, crossover protocol, in which toddlers (n = 18, 2-3 years old) were randomly assigned into six groups, according to possible combinations of dentifrices (0/550/1,100 ppm F, as NaF) and amounts (rice grain, pea size, and transverse technique). Volunteers used a F-free dentifrice during 1 week. On the 7th day, saliva samples were collected before (baseline), and at 5/15/30/60 min after toothbrushing. All dentifrice expectorated after brushing was collected. F concentrations (saliva and expectorate) were determined with an ion-specific electrode. Data were submitted to ANOVA or Kruskal-Wallis test, followed by Fisher's LSD or Student-Newman-Keuls' tests (p <0.05). Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain). The highest AUC and salivary F at 5 min after brushing were achieved by 1,100 ppm F (pea size), followed by 550 ppm F (transversal technique). Regarding F intake, the highest values were observed for 550 ppm F (transversal technique), followed by 1,100 ppm F (pea size). It is possible to conclude that the amount of dentifrice and F concentration in the product significantly affected both salivary F concentrations and F intake during toothbrushing.",2020,"Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain).","['toddlers (n = 18, 2-3 years old', 'Toddlers']","['Dentifrice and Fluoride', 'F-free dentifrice', 'Brushing with 550 ppm F dentifrice (pea size or transversal technique']","['salivary F concentrations and F intake', 'F concentrations (saliva and expectorate']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0232515', 'cui_str': 'Spitting'}]",,0.0436303,"Brushing with 550 ppm F dentifrice (pea size or transversal technique) increased the area under the curve (AUC) at similar levels compared to 1,100 ppm F (rice grain).","[{'ForeName': 'Caio', 'Initials': 'C', 'LastName': 'Sampaio', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Alberto Carlos Botazzo', 'Initials': 'ACB', 'LastName': 'Delbem', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Mayra Frasson', 'Initials': 'MF', 'LastName': 'Paiva', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Zen', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Danelon', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Robson Frederico', 'Initials': 'RF', 'LastName': 'Cunha', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil.'}, {'ForeName': 'Juliano Pelim', 'Initials': 'JP', 'LastName': 'Pessan', 'Affiliation': 'Department of Preventive and Restorative Dentistry, School of Dentistry, São Paulo State University (UNESP), Araçatuba, Brazil, juliano.pessan@unesp.br.'}]",Caries research,['10.1159/000503780']
979,32521096,Comparing Exposure- and Coping Skills-Based Treatments on Trauma-Related Guilt in Veterans With Co-Occurring Alcohol Use and Posttraumatic Stress Disorders.,"Posttraumatic stress disorder (PTSD) and substance use disorders (SUD) commonly co-occur, and this comorbidity (PTSD-SUD) is associated with more severe symptoms and functional impairment than either disorder alone. Growing evidence indicates that trauma-related guilt, typically concerning negative appraisals of one's actions or inaction during a traumatic event, is associated with PTSD, depression, suicidality, and, possibly, substance use. The present study examined whether integrated treatment for PTSD-SUD was effective in reducing trauma-related guilt as measured by the Trauma-Related Guilt Inventory. Data were drawn from a randomized clinical trial comparing the effectiveness of two integrated therapies on treatment outcomes in a sample of U.S. veterans (N = 119) with comorbid PTSD and SUD. Participants were randomized to receive either Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE; n = 63) or Seeking Safety (SS; n = 56). The results indicated that global guilt decreased over time for the whole sample. However, there was a significant Treatment × Time interaction, such that participants in the COPE condition reported lower rates of global guilt, d = 0.940, over time compared to those in the SS condition, d = .498. To our knowledge, this was the first study to examine the effects of integrated PTSD-SUD treatment on trauma-related guilt. The findings highlight that exposure-based, trauma-focused treatment for comorbid PTSD-SUD can be more effective in decreasing trauma-related guilt, with potentially longer-lasting effects, than non-exposure-based treatment, adding evidence that patients with PTSD-SUD should be offered such treatment.",2020,"However, there was a significant Treatment × Time interaction, such that participants in the COPE condition reported lower rates of global guilt, d = 0.940, over time compared to those in the SS condition, d = .498.","['Veterans with Co-Occurring Alcohol Use and Posttraumatic Stress Disorders', 'a sample of U.S. veterans (N = 119) with comorbid PTSD and SUD']","['integrated PTSD-SUD', 'Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE; n = 63) or Seeking Safety (SS', 'Exposure- and Coping Skills-Based Treatments']","['global guilt', 'rates of global guilt']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}]",119.0,0.017374,"However, there was a significant Treatment × Time interaction, such that participants in the COPE condition reported lower rates of global guilt, d = 0.940, over time compared to those in the SS condition, d = .498.","[{'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Capone', 'Affiliation': 'Providence VA Medical Center, Providence, Rhode Island, USA.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Brittany C', 'Initials': 'BC', 'LastName': 'Davis', 'Affiliation': 'James A Haley Veterans Hospital, Tampa, Florida, USA.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22538']
980,32521100,Social Support Moderates the Association Between Posttraumatic Stress Disorder Treatment Duration and Treatment Outcomes in Telemedicine-Based Treatment Among Rural Veterans.,"For patients participating in trauma-focused psychotherapies for posttraumatic stress disorder (PTSD), such as cognitive processing therapy (CPT), pretreatment characteristics may moderate treatment effectiveness. For instance, preexisting supportive relationships may encourage skill utilization or provide contrasts to maladaptive cognitive biases highlighted in trauma-focused treatments for PTSD. Such pretreatment characteristics are important to study in rural individuals, who may experience barriers to initiating and completing treatment. The aim of this study was to examine whether pretreatment social support, measured using the Medical Outcomes Study Social Support Survey, would moderate the association between CPT duration (i.e., number of sessions attended) and change in PTSD symptoms, using data from a pragmatic randomized controlled trial of a telemedicine-based collaborative care intervention for rural veterans (N = 225). Social support moderated the association between CPT duration and PTSD symptom change, B = -0.016, SE = -.006; 95% CI [-0.028, -0.005], such that increased duration was associated with more PTSD symptom change only at average or higher levels of support. This effect was found for overall and emotional support but not tangible support. Additionally, on average, among participants who attended eight or more CPT sessions, only those at or above 1 standard deviation above the mean social support score demonstrated a reliable change in PTSD symptoms. The results indicate that the link between CPT treatment duration and treatment outcomes may be stronger for veterans with higher levels of pretreatment social support.",2020,"Social support moderated the association between CPT duration and PTSD symptom change, B = -0.016, SE = -.006; 95% CI [-0.028, -0.005], such that increased duration was associated with more PTSD symptom change only at average or higher levels of support.","['Rural Veterans', 'rural veterans (N = 225', 'patients participating in trauma-focused psychotherapies for posttraumatic stress disorder (PTSD', 'rural individuals']","['cognitive processing therapy (CPT', 'CPT', 'telemedicine-based collaborative care intervention']","['PTSD symptoms', 'CPT duration and PTSD symptom change', 'PTSD symptom change']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",225.0,0.0143797,"Social support moderated the association between CPT duration and PTSD symptom change, B = -0.016, SE = -.006; 95% CI [-0.028, -0.005], such that increased duration was associated with more PTSD symptom change only at average or higher levels of support.","[{'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Erbes', 'Affiliation': 'Minneapolis VA Health Care System, Center for Chronic Disease Outcomes Research, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Grubbs', 'Affiliation': 'VA San Diego Health Care System, San Diego, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fortney', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}]",Journal of traumatic stress,['10.1002/jts.22542']
981,32533723,Preoperative high-dose Steroids in Total Knee and Hip Arthroplasty - Protocols for three randomized controlled trials.,"BACKGROUND
Patients undergoing total knee arthroplasty (TKA)/ total hip arthroplasty (THA) still experience moderate-severe postoperative pain despite optimized pain management regimes. The patients already on opioid treatment and pain catastrophizers (PCs) have a higher risk of postoperative pain. The use of preoperative intravenous high-dose glucocorticoids decreases postoperative pain after TKA and THA, but optimal dose is yet to be found, and the effect on subpopulations at high pain risk is unknown.
AIM
To investigate the effect of a higher than previously used dose of glucocorticoids (dexamethasone (DXM)), administered intravenously before surgery, as part of standardized fast-track regimen, on postoperative pain in TKA/THA subgroups.
METHOD
Three separate randomized, double-blinded, controlled trials were planned to compare a new higher dose DXM (1 mg/kg) to the earlier used high-dose DXM (0.3 mg/kg). Study 1: predicted Low Pain TKA; study 2: predicted High Pain Responder (HPR) TKA; study 3: predicted HPR THA. Predicted HPR groups consist of either PCs with PCS-score of ≥ 21 and/or history of ongoing opioid-treatment of 30 mg/day of morphine or equivalents > 30 days. In total, 408 patients were planned for inclusion (160 Low Pain TKA, 88 HPR TKA, 160 HPR THA).
PRIMARY OUTCOME
Pain upon ambulation in a 5-meter walk test 24 hours after surgery. Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity, and mortality. Patients completed follow-up on day 90. Recruiting commenced February 2019 and is expected to finish in September 2020.",2020,"Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality.","['408 patients in total are planned for inclusion (160 Low Pain TKA, 88 HPR TKA, 160 HPR THA', 'Total Knee and Hip Arthroplasty - Protocols', 'Patients undergoing total knee arthroplasty (TKA) / total hip arthroplasty (THA) still experience moderate-severe postoperative pain despite optimized pain management regimes']","['glucocorticoids (dexamethasone (DXM', 'glucocorticoids', 'DXM', 'Preoperative high-dose Steroids', 'morphine']","['Pain upon ambulation in a 5-meter walk test 24 hours after surgery', 'use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality']","[{'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.22163,"Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality.","[{'ForeName': 'Niklas I', 'Initials': 'NI', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology, 7621, Rigshospitalet, University of Copenhagen, Blegdamsvej, Denmark.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Gromov', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Varnum', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kjaersgaard-Andersen', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Lasse E', 'Initials': 'LE', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Mandøe', 'Affiliation': 'Department of Anaesthesiology, Lillebaelt Hospital -Vejle, Vejle, Denmark.'}, {'ForeName': 'Nicolai B', 'Initials': 'NB', 'LastName': 'Foss', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13656']
982,32531070,Effect of different general anaesthetics on ventricular repolarisation in robot-assisted laparoscopic prostatectomy.,"BACKGROUND
Ventricular repolarisation is affected differently by the types of anaesthetics used. This study aimed to compare the effect of different types of anaesthetics on ventricular repolarisation during robot-assisted laparoscopic radical prostatectomy (RALP).
METHODS
Sixty-nine patients were randomly assigned in a 1:1:1 ratio to the Sevoflurane (sevoflurane/remifentanil), Desflurane (desflurane/remifentanil) or total intravenous anaesthesia (TIVA [propofol/remifentanil]) groups; however, only 67 patients completed the study. The primary outcome was heart rate-corrected QT (QTc) interval collected at nine time points during RALP. Bazett's (QTcB) and Fridericia's (QTcF) formulae were used for QT interval correction. The secondary outcomes were Tpeak-Tend (Tp-e) interval and Tp-e/QT ratio that were collected at the same time points.
RESULTS
The QTcB and QTcF intervals were significantly prolonged during surgery in all groups; however, these values showed significant intergroup differences with time. After assuming the Trendelenburg position, the QTcB and QTcF intervals were significantly longer in the Desflurane group than in the other two groups, and this prolongation continued until the end of surgery. Intra-operatively, the QTcB and QTcF intervals exceeded 450 ms in six and five patients, respectively, in the Desflurane group, but in none in the TIVA group. Moreover, the incidence of intra-operative QTc interval prolongation >20 ms and >60 ms was significantly higher in the Desflurane group than in the TIVA group. There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery.
CONCLUSIONS
To minimise QTc interval prolongation during RALP, TIVA with propofol/remifentanil is recommended for general anaesthesia.",2020,"There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery.
","['Sixty-nine patients', '67 patients completed the study']","['general anaesthetics', 'robot-assisted laparoscopic prostatectomy', 'propofol/remifentanil', 'anaesthetics', 'Desflurane', 'robot-assisted laparoscopic radical prostatectomy (RALP', 'total intravenous anaesthesia (TIVA [propofol/remifentanil', 'Sevoflurane (sevoflurane/remifentanil', 'Desflurane (desflurane/remifentanil']","['ventricular repolarisation', 'QTcB and QTcF intervals', 'intraoperative QTc interval prolongation', 'Tp-e intervals and Tp-e/QT ratio', 'Tpeak-Tend (Tp-e) interval and Tp-e/QT ratio', ""Bazett's (QTcB) and Fridericia's (QTcF) formulae"", 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",69.0,0.0291972,"There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery.
","[{'ForeName': 'Jin Ha', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Deuk', 'Initials': 'YD', 'LastName': 'Choi', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jongsoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Woo', 'Initials': 'DW', 'LastName': 'Han', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Baek', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13653']
983,32530523,"Patient-reported outcomes after 10-year follow-up of intensive, multifactorial treatment in individuals with screen-detected type 2 diabetes: the ADDITION-Europe trial.","AIMS
To present the longer-term impact of multifactorial treatment of type 2 diabetes on self-reported health status, diabetes-specific quality of life, and diabetes treatment satisfaction at 10-year follow up of the ADDITION-Europe trial.
METHODS
The ADDITION-Europe trial enrolled 3057 individuals with screen-detected type 2 diabetes from four centres [Denmark, the UK (Cambridge and Leicester) and the Netherlands], between 2001 and 2006. Participants were randomized at general practice level to intensive treatment or to routine care . The trial ended in 2009 and a 10-year follow-up was performed at the end of 2014. We measured self-reported health status (36-item Short-Form Health Survey and EQ-5D), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life questionnaire), and diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire) at different time points during the study period. A mixed-effects model was applied to estimate the effect of intensive treatment (intention-to-treat analyses) on patient-reported outcome measures for each centre. Centre-specific estimates were pooled using a fixed effects meta-analysis.
RESULTS
There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01 (95% CI -0.03, 0.01); Physical Composite Score (36-item Short-Form Health Survey): -0.27 (95% CI -1.11, 0.57), Audit of Diabetes-Dependent Quality of Life questionnaire: -0.01 (95% CI -0.11, 0.10); and Diabetes Treatment Satisfaction Questionnaire: -0.20 (95% CI -0.70, 0.29)].
CONCLUSIONS
Intensive, multifactorial treatment of individuals with screen-detected type 2 diabetes did not affect self-reported health status, diabetes-specific quality of life, or diabetes treatment satisfaction at 10-year follow-up compared to routine care.",2020,There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01,"['3057 individuals with screen-detected type 2 diabetes from four centres [Denmark, the UK (Cambridge and Leicester) and the Netherlands], between 2001 and 2006', 'individuals with screen-detected type 2 diabetes']",['intensive treatment or to routine care '],"['self-reported health status (36-item Short-Form Health Survey and EQ-5D), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life questionnaire), and diabetes treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire', 'Physical Composite Score (36-item Short-Form Health Survey', 'health status, diabetes-specific quality of life, or diabetes treatment satisfaction', 'Audit of Diabetes-Dependent Quality of Life questionnaire', 'Diabetes Treatment Satisfaction Questionnaire: -0.20', 'health status, diabetes-specific quality of life, and diabetes treatment satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451116', 'cui_str': 'Diabetes treatment satisfaction questionnaire'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3057.0,0.0852594,There was no difference in patient-reported outcome measures between the routine care and intensive treatment arms in this 10-year follow-up study [EQ-5D: -0.01,"[{'ForeName': 'E-M', 'Initials': 'EM', 'LastName': 'Dalsgaard', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sandbaek', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'G E H M', 'Initials': 'GEHM', 'LastName': 'Rutten', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Irving', 'Affiliation': 'Primary Care Unit, Institute of Public Health, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Vos', 'Affiliation': 'Julius Centre for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Webb', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Wareham', 'Affiliation': 'MRC Epidemiology Unit, Institute of Metabolic Science, School of Clinical Medicine, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Witte', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14342']
984,32527382,"Treatment of Alcohol Dependence in Primary Care Compared With Outpatient Specialist Treatment: Twelve-Month Follow-Up of a Randomized Controlled Trial, With Trajectories of Change.","OBJECTIVE
The purpose of this study was to investigate if brief treatment for alcohol dependence in primary care with the 15-method was as effective as specialist addiction care. In addition, we sought to investigate trajectories for change of alcohol consumption.
METHOD
This study was a randomized controlled noninferiority trial, between-groups parallel design, with a noninferiority limit of 50 g of alcohol per week. A total of 288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic. The primary outcome was change in weekly alcohol consumption at the 12-month follow-up. Secondary outcomes were heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers. Trajectories were investigated using change in World Health Organization drinking risk levels.
RESULTS
The intention-to-treat analysis (n = 231) showed that the estimated weekly alcohol consumption in primary care was 18.2 g (95% CI [14.9, 51.3]) higher compared with specialist care (p = .28). Noninferiority was not demonstrated as the confidence interval exceeded the noninferiority limit. The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment. The analyses of trajectories showed the main part of change in consumption occurred from baseline to the 6-month follow-up and was maintained to the 12-month follow-up.
CONCLUSIONS
Although noninferiority could not be demonstrated, based on similar trajectories and sustained reduction of alcohol use, this study indicates brief treatment of alcohol dependence in primary care with the 15-method is a feasible and promising approach.",2020,The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment.,['288 adults fulfilling ICD-10 criteria for alcohol dependence were randomized to treatment in primary care or specialist outpatient care at a university addiction clinic'],['Outpatient Specialist Treatment'],"['change in weekly alcohol consumption', 'change in consumption', 'heavy drinking days, severity of dependence, consequences of drinking, psychological health, quality of life, satisfaction with treatment, and biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0556347', 'cui_str': 'Drinking day'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",288.0,0.0610297,The secondary outcomes showed no differences between primary care and specialist care except that patients randomized to specialist care were more satisfied with treatment.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wallhed Finn', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Andréasson', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Hammarberg', 'Affiliation': 'Department of Clinical Neurosciences, Karolinska Institutet, Centre for Psychiatry Research, Stockholm Health Care Services, Stockholm, Sweden.'}]",Journal of studies on alcohol and drugs,[]
985,32527389,Effects of Age and Acute Moderate Alcohol Consumption on Electrophysiological Indices of Attention.,"OBJECTIVE
Despite increased attention to risks and benefits associated with moderate drinking lifestyles among aging adults, relatively few empirical studies focus on acute alcohol effects in older drinkers. Using electroencephalographic indices of early attention modulation (P1 and N1) and later stimulus processing (P3), we investigated whether acute alcohol consumption at socially relevant doses differentially influences neurocognitive performance in older, relative to younger, moderate drinkers.
METHOD
Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers were randomly assigned to receive one of three alcohol doses (placebo, .04 g/dl, or .065 g/dl target breath alcohol concentrations). Repeated-measures analysis of variance examined the effects of age, alcohol dose concentration, and their potential interaction on P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task.
RESULTS
Age-specific effects on P1 amplitudes varied by instruction set, with alcohol-associated decreases in amplitude among older drinkers in response to task-relevant stimuli and increases to irrelevant stimuli, F(2, 141) = 2.70, p = .07, η p 2 = .04. In contrast, N1 analyses demonstrated alcohol-related latency reductions among older, relative to younger, adults, F(2, 83) = 3.42, p = .04. Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) = 5.73, p < .01, η p 2 = .08.
CONCLUSIONS
Our results underscore the impact of acute moderate alcohol consumption on attentional functioning, highlighting age-dependent sensitivity in electrophysiological indices of early attentional processing. Given the import of attentional functioning to quality of life and increases in drinking among a rapidly expanding aging population, these findings have broad public health relevance.",2020,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","['older drinkers', 'older, relative to younger, moderate drinkers', 'Younger (25-35 years; n = 97) and older (55-70 years; n = 87) healthy drinkers']","['early attention modulation (P1 and N1) and later stimulus processing (P3', 'alcohol doses (placebo, .04']",['P1/P3 amplitudes and N1 latency during completion of a directed attend/ignore task'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337677', 'cui_str': 'Moderate drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]",87.0,0.0715192,"Although no Age × Alcohol interactions were detected for P3, main effects indicated dose-dependent amplitude reductions for relevant stimuli, F(2, 144) =","[{'ForeName': 'Christian C', 'Initials': 'CC', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Boissoneault', 'Affiliation': 'University of Florida Center for Addiction Research & Education, Gainesville, Florida.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Nixon', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, Florida.'}]",Journal of studies on alcohol and drugs,[]
986,32532698,Satisfaction or Distraction: Exposure to Nonpreferred Music May Alter the Learning Curve for Surgical Trainees.,"OBJECTIVE
There is growing evidence supporting the benefits of preferred music on task performance, however there is a paucity of data regarding the potential impact on surgical and procedural learners. This study aims to assess the effects of nonpreferred music on surgical and procedural learners.
DESIGN
This was a single-blinded, randomized crossover trial in which each participant completed a survey regarding their demographic information and music preferences. Each participant then completed 3 training tasks, and 2 repetitions of the evaluative task while listen to music. Tasks were completed using a Da Vinci Skills Simulator Si.
SETTING
All tasks were completed in a live operating room at the University of Kansas Hospital, a tertiary care center.
PARTICIPANTS
Medical students at the University of Kansas Medical Center were recruited by email to participate. In total, 31 medical students completed the experience.
RESULTS
Thirty-one participants participated in this study. Group 2 (preferred music first, nonpreferred music second) showed no significant change in their test scores (72.73 vs 74.33, p = 0.34). However, Group 1 (nonpreferred music first, then preferred music) showed significant improvement between trial runs (70.31 vs 81.88, p < 0.001). There was no significant difference between the initial runs for each group. When analyzed irrespective of group assignment, there was a significant increase in scores for preferred music vs nonpreferred music (77.45 vs 72.26 p = 0.025).
CONCLUSIONS
Participants showed expected improvement with task repetition. This improvement may have been offset by exposure to nonpreferred music during repeat runs. Our findings suggest that the impact of music was nearly as large as the impact of prior exposure to the task. This may have implications for environmental conditions during resident procedural training, especially early in residency training when new tasks are being introduced and the skill level of the learner is still low.",2020,"When analyzed irrespective of group assignment, there was a significant increase in scores for preferred music vs nonpreferred music (77.45 vs 72.26 p = 0.025).
","['All tasks were completed in a live operating room at the University of Kansas Hospital, a tertiary care center', 'Medical students at the University of Kansas Medical Center were recruited by email to participate', '31 medical students completed the experience', 'Thirty-one participants participated in this study']","['nonpreferred music', 'Nonpreferred Music']","['task repetition', 'test scores']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",31.0,0.134697,"When analyzed irrespective of group assignment, there was a significant increase in scores for preferred music vs nonpreferred music (77.45 vs 72.26 p = 0.025).
","[{'ForeName': 'Kellen', 'Initials': 'K', 'LastName': 'Gil', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas. Electronic address: kgil@kumc.edu.'}, {'ForeName': 'Maddie', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Mouw', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Mazin', 'Initials': 'M', 'LastName': 'Al-Kasspooles', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Tejal', 'Initials': 'T', 'LastName': 'Brahmbhatt', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'DiPasco', 'Affiliation': 'Department of Surgery, University of Kansas Medical Center, Kansas City, Kansas.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.04.019']
987,32532705,Naltrexone in Compulsive Sexual Behavior Disorder: A Feasibility Study of Twenty Men.,"BACKGROUND
Compulsive sexual behavior disorder (CSBD) is a common disorder affecting different areas of life, although studies focusing on pharmacological treatment are sparse.
AIM
To investigate whether the opioid receptor antagonist naltrexone is feasible and tolerable and can provide symptom reduction in CSBD.
METHODS
Twenty men aged 27-60 years (mean = 38.8 years, standard deviation = 10.3) with CSBD seeking treatment in an outpatient nonforensic clinic received four weeks of naltrexone 25-50 mg. Measurements were made before, during, and four weeks after treatment.
OUTCOMES
The self-assessment Hypersexual Disorder: Current Assessment Scale (HD: CAS) score was the primary outcome measure, and secondary outcomes were the Hypersexual Behavior Inventory (HBI) score, reported adverse effects, adherence to treatment, and dropouts.
RESULTS
There was significant decrease on both HD: CAS and HBI scores during treatment with naltrexone. Even though some of the effects remained after treatment, the increased scores on HD: CAS indicated worsening of CSBD symptoms. The most reported side effects were fatigue (55%), nausea (30%), vertigo (30%), and abdominal pain (30%). However, there were no serious adverse effects leading to discontinuation of naltrexone.
CLINICAL IMPLICATIONS
Despite side effects being common, naltrexone seems to be feasible in the treatment of CSBD.
STRENGTHS & LIMITATIONS
Being the first nonforensic prospective trial on naltrexone in CSBD, this study provides novel insights on a pharmacological intervention. However, owing to the small sample size and the lack of a control group, conclusions of effectiveness should be interpreted with caution.
CONCLUSION
Naltrexone is feasible and tolerable and may reduce symptoms of CSBD; nevertheless, future studies should ensure a randomized controlled procedure to evaluate possible effectiveness. Savard J, Öberg KG, Chatzittofis A, et al. Naltrexone in Compulsive Sexual Behavior Disorder: A Feasibility Study of Twenty Men. J Sex Med 2020;17:1544-1552.",2020,There was significant decrease on both HD: CAS and HBI scores during treatment with naltrexone.,"['Twenty men aged 27-60 years (mean\xa0= 38.8 years, standard deviation\xa0= 10.3) with CSBD seeking treatment in an outpatient nonforensic clinic received four weeks of', 'Twenty Men', 'Compulsive Sexual Behavior Disorder']","['opioid receptor antagonist naltrexone', 'naltrexone', 'Naltrexone', 'naltrexone 25-50 mg']","['self-assessment Hypersexual Disorder', 'CSBD symptoms', 'Current Assessment Scale (HD: CAS) score', 'Hypersexual Behavior Inventory (HBI) score, reported adverse effects, adherence to treatment, and dropouts', 'vertigo', 'nausea', 'abdominal pain', 'HD: CAS and HBI scores']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0312420', 'cui_str': 'Hypersexuality state'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0312420', 'cui_str': 'Hypersexuality state'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]",20.0,0.0529634,There was significant decrease on both HD: CAS and HBI scores during treatment with naltrexone.,"[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Savard', 'Affiliation': 'Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden. Electronic address: josephine.savard@umu.se.'}, {'ForeName': 'Katarina Görts', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Chatzittofis', 'Affiliation': 'Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden; Medical School, University of Cyprus, Nicosia, Cyprus.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.04.318']
988,32540179,Comparing the usefulness of a fluoroscopic navigation system in femoral trochanteric fracture for orthopaedic residents with the conventional method.,"INTRODUCTION
Lag screw insertion into the ideal position is essential to obtain good results in open reduction and internal fixation for femoral trochanteric fracture. Tip-apex distance (TAD) is a widely adopted method for evaluating the risk of lag screw cut-out. Adaptive positioning technology (ADAPT) is a fluoroscopic computer-assisted surgery system that enables orthopaedic surgeons to guide the screw into a proper position intraoperatively. A randomized control study concluded that ADAPT resulted in excellent TAD. However, it was not significantly better than conventional methods when performed by fellowship-trained traumatologists. Therefore, we hypothesised that ADAPT would be useful to orthopaedic residents and evaluated this usefulness.
METHODS
We reviewed 102 patients who underwent open reduction and internal fixation for femoral trochanteric fracture from May 2017 to March 2019 using Gamma-3 intertrochanteric nails. Two residents performed all procedures; 51 patients underwent surgery using ADAPT and the others underwent surgery without navigation. The number of attempts to drill guide-wire, operation time, lag screw insertion time, radiation exposure time, TAD, and lag screw position were evaluated for each surgeon.
RESULTS
In one resident, when using the ADAPT system, the number of attempts to drill guide-wire (p=0.001), lag screw insertion time (p=0.000), radiational exposure time (p=0.009) and TAD (p=0.007) were lower, and the percentage of ideal lag screw position (p=0.035) were better than that in the conventional method. However, there was no significant difference in the performance of another resident with respect to the aforementioned factors, whether using ADAPT or not.
CONCLUSION
One resident showed better results with the ADAPT system than with conventional osteosynthesis. However, another resident received no benefit from ADAPT. The efficiency may not apply to everyone as individual competence can influence efficiency when using ADAPT system. Therefore, as a new device, it must be used cautiously because skill or experience may influence its use, especially by orthopaedic residents.",2020,Adaptive positioning technology (ADAPT) is a fluoroscopic computer-assisted surgery system that enables orthopaedic surgeons to guide the screw into a proper position intraoperatively.,"['102 patients who underwent open reduction and internal fixation for femoral trochanteric fracture from May 2017 to March 2019 using Gamma-3 intertrochanteric nails', 'femoral trochanteric fracture for orthopaedic residents with the conventional method']","['surgery using ADAPT and the others underwent surgery without navigation', 'conventional osteosynthesis', 'fluoroscopic navigation system', 'Tip-apex distance (TAD', 'Adaptive positioning technology (ADAPT']","['radiational exposure time', 'number of attempts to drill guide-wire, operation time, lag screw insertion time, radiation exposure time, TAD, and lag screw position', 'excellent TAD', 'percentage of ideal lag screw position', 'lag screw insertion time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",102.0,0.0170369,Adaptive positioning technology (ADAPT) is a fluoroscopic computer-assisted surgery system that enables orthopaedic surgeons to guide the screw into a proper position intraoperatively.,"[{'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takai', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan. Electronic address: hirokazoid@hotmail.co.jp.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Mizuta', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Murayama', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Nakayama', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Sakumo', 'Initials': 'S', 'LastName': 'Kii', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Hayai', 'Affiliation': 'Imaging Diagnostic Center, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, Kumamoto Kinoh Hospital, Kumamoto, Japan.'}]",Injury,['10.1016/j.injury.2020.06.001']
989,32540210,Does accreditation affect the job satisfaction of general practitioners? A combined panel data survey and cluster randomised field experiment.,"A critical question for policy makers in health care is whether external interventions have unintended consequences such as lowering professionals' job satisfaction. We investigate whether a non-monetary incentive, in the form of mandatory accreditation, affects the job satisfaction of Danish GPs. Accreditation of general practice in Denmark was introduced as a cluster randomised stepwise implementation from 2016 to 2018. We measure job satisfaction at three time points: before the randomisation took place, one year into the accreditation process and two years into the accreditation process. We use a balanced panel of GPs who have completed all three waves of the survey (n = 846) and estimate a series of random and mixed effects ordered logit models. Despite many GPs having negative attitudes towards accreditation, we find no evidence of accreditation affecting GP job satisfaction. However, there are negative associations between job satisfaction and perceiving accreditation as a tool for external control. Policy makers are therefore encouraged to carefully inform about new interventions and identify barriers to diminish pre-existing negative perceptions about the incentive.",2020,"We investigate whether a non-monetary incentive, in the form of mandatory accreditation, affects the job satisfaction of Danish GPs.",[],[],['job satisfaction'],[],[],"[{'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",,0.0348546,"We investigate whether a non-monetary incentive, in the form of mandatory accreditation, affects the job satisfaction of Danish GPs.","[{'ForeName': 'Line Bjørnskov', 'Initials': 'LB', 'LastName': 'Pedersen', 'Affiliation': 'DaCHE - Danish Centre for Health Economics, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9B, 5000 Odense C, Denmark; Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark. Electronic address: lib@sdu.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Allen', 'Affiliation': 'Manchester Centre for Health Economics, University of Manchester, Oxford Road, Manchester M13 9PL, UK.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark.'}, {'ForeName': 'Merethe Kirstine Kousgaard', 'Initials': 'MKK', 'LastName': 'Andersen', 'Affiliation': 'Research Unit for General Practice, Institute of Public Health, University of Southern Denmark, J.B. Winsløwsvej 9A, 5000 Odense C, Denmark.'}]","Health policy (Amsterdam, Netherlands)",['10.1016/j.healthpol.2020.04.002']
990,32533354,"A comparison of nasogastric tube insertion by SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) versus neck flexion lateral pressure in critically ill patients admitted to ICU: a prospective randomized clinical trial.","BACKGROUND
Although many techniques have been introduced to facilitate nasogastric tube (NGT) insertion using anatomic landmarks and a group of devices, there is a lack of general consensus regarding a standard method. The current study purposed to investigate if SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) increases the success rate of NGT correct placement versus neck flexion lateral pressure (NFLP) method.
METHODS
A randomized controlled trial study was conducted in two university affiliated intensive care units (tertiary referral center). Three hundred and ninety-six critically ill patients older than 18 years of age were randomly divided into SORT (n = 200) and NFLP (n = 196) groups. The technique was classified as ""failed"" after the third unsuccessful attempt. Patient characteristics, success rate for the first attempt, time required for the successful first attempt and overall successful insertion time, various complications including kinking, coiling and bleeding and ease of insertion were noted as main outcomes measured.
RESULTS
Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001). The number of failed attempts was significantly higher in the NFLP group (7.5%) vs the SORT group (3.0%) (P = 0.046). The pattern of complications was not different between two study groups (P = 0.242). The odds of stage II (odds ratio (OR) = 49.9; 95% confidence interval (CI) 25.2 to 98.6), stage III (OR = 67.1; 95% CI 14.9 to 302.8)) and stage IV (OR = 11.8; 95% CI 3.4 to 41.2) ease of insertion were much higher in NFLP compared to SORT group, after adjusting for age and body mass index (BMI). The odds of failure was not significantly different in NFLP group compared to SORT group (OR = 2.3; 95% CI 0.85 to 6.3), after adjusting for age and BMI.
CONCLUSIONS
SORT technique may be considered as a promising method for successful NGT insertions in critically ill patients. However, more trials are needed to confirm the results of this study. The decision must account for individual patient and clinical factors and the operator's experience and preference.
TRIAL REGISTRATION
The study was registered at government registry of clinical trials in Iran (http://www.IRCT.ir) (number: IRCT20091012002582N18, 13 March 2018).",2020,"RESULTS
Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001).","['two university affiliated intensive care units (tertiary referral center', 'critically ill patients', 'critically ill patients admitted to ICU', 'Three hundred and ninety-six critically ill patients older than 18\xa0years of age']","['nasogastric tube insertion by SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement) versus neck flexion lateral pressure', 'IRCT.ir', 'NFLP', 'SORT maneuver (sniffing position, NGT orientation, contralateral rotation, and twisting movement', 'NGT correct placement versus neck flexion lateral pressure (NFLP) method']","['number of failed attempts', 'pattern of complications', 'success rate for the first attempt, time required for the successful first attempt and overall successful insertion time, various complications including kinking, coiling and bleeding and ease of insertion', 'odds of failure']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C1301705', 'cui_str': 'Sniffing position'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",396.0,0.120383,"RESULTS
Ease of insertion was significantly better in the SORT group compared to the NFLP group (P < 0.001).","[{'ForeName': 'Sarvin', 'Initials': 'S', 'LastName': 'Sanaie', 'Affiliation': 'Neurosciences Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Mirzalou', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samad E J', 'Initials': 'SEJ', 'LastName': 'Golzari', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Soleimanpour', 'Affiliation': 'Neurosciences Research Center, Aging Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Shamekh', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Bettampadi', 'Affiliation': 'Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Safiri', 'Affiliation': 'Tuberculosis and Lung Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. amahmoodpoor@yahoo.com.'}]",Annals of intensive care,['10.1186/s13613-020-00696-2']
991,32548702,"Association of diabetes-related autoantibodies with the incidence of asthma, eczema and allergic rhinitis in the TRIGR randomised clinical trial.","AIMS/HYPOTHESIS
This paper presents the relationship between islet autoantibodies, precursors of type 1 diabetes, and the development of persistent asthma, allergic rhinitis and atopic eczema.
METHODS
A total of 2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10 years of age. Islet cell antibodies (ICA) were detected using indirect immunofluorescence. Autoantibodies to insulin (IAA), GAD (GADA), the tyrosine phosphatase-related insulinoma-associated 2 molecule (IA-2A) and zinc transporter 8 (ZnT8A) were quantified with the use of specific radiobinding assays. As an ancillary study, the incidence of asthma, allergic rhinitis and eczema was assessed in 1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11 years old. HRs with 95% CIs were calculated to depict the incidence of these diseases following seroconversion to autoantibody positivity.
RESULTS
The cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma were 22%, 9% and 7.5%, respectively, by 9-11 years of age. The occurrence of diabetes-related autoantibodies showed a protective association with subsequently reported incidence of asthma and eczema. The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
CONCLUSIONS/INTERPRETATION
The findings add evidence to the relationships between these atopic diseases and diabetes-related autoimmunity and also suggest that, for eczema, the interaction depends upon which autoantibody appeared first.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00179777 Graphical abstract.",2020,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","['2159 newborns who had a first-degree relative with type 1 diabetes and selected HLA genotypes were followed until the youngest participant reached 10\xa0years of age', '1106 of these children using the International Study of Asthma and Allergies in Childhood (ISAAC) core questionnaire when the children were 9-11\xa0years old']",[],"['occurrence of IAA or GADA', 'cumulative incidence of atopic eczema, allergic rhinitis and persistent asthma', 'incidence of asthma, allergic rhinitis and eczema', 'Autoantibodies to insulin (IAA), GAD (GADA', 'incidence of rhinitis', 'Islet cell antibodies (ICA']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444502', 'cui_str': 'First degree'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0004358', 'cui_str': 'Autoantibody'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0063900', 'cui_str': 'Anti-pancreatic islet cell antibody'}]",2159.0,0.0442462,"The incidence of rhinitis was not significantly related to the occurrence of IAA or GADA (statistical power was limited), but demonstrated the same inverse relationship as did the other diseases with ICA or when multiple autoantibodies first appeared together.
","[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA. jeffrey.krischer@epi.usf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cuthbertson', 'Affiliation': 'Health Informatics Institute, Morsani College of Medicine, University of South Florida, 3650 Spectrum Boulevard, Suite 100, Tampa, FL, 33612, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Couluris', 'Affiliation': 'Department of Pediatrics, Morsani College of Medicine, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Knip', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Suvi M', 'Initials': 'SM', 'LastName': 'Virtanen', 'Affiliation': 'Unit of Public Health Promotion, National Institute for Health and Welfare, Helsinki, Finland.'}]",Diabetologia,['10.1007/s00125-020-05188-3']
992,32546726,Phase II trial of CPX-351 in patients with acute myeloid leukemia at high risk for induction mortality.,"CPX-351 is a liposomal formulation of cytarabine/daunorubicin with a 5:1 fixed molar ratio. We investigated the safety and efficacy of escalating doses of CPX-351 in patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial. Patients were randomized to receive 50 or 75 units/m 2 on days 1, 3, and 5. Once safety was established, a 100 units/m 2 arm was opened. Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100 units/m 2 arms, respectively. The composite complete remission rate (complete remission + complete remission with incomplete blood count recovery) was lowest with 50 units/m 2 (19%) compared with 75 units/m 2 (38%) and 100 units/m 2 (44%) (P = 0.35). The 50 units/m 2 arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2 respectively (P = 0.04). Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia (34%), pneumonia (23%), and sepsis (16%). CPX-351 at 75 units/m 2 has favorable safety and efficacy for AML patients at high risk of induction mortality with some tolerating the standard dose of 100 units/m 2 .",2020,"The 50 units/m 2 arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2 respectively (P = 0.04).","['patients with acute myeloid leukemia at high risk for induction mortality', 'Fifty-six patients were enrolled, 16, 24, and 16 in the 50, 75, and 100\u2009units/m 2 arms, respectively', 'patients with acute myeloid leukemia (AML) at high risk of induction mortality with standard chemotherapy determined through assessment of leukemia and patient-related risk factors for intensive chemotherapy in an open-label, phase II trial']","['cytarabine/daunorubicin', 'CPX-351']","['median OS', 'safety and efficacy', 'Nonhematologic grade 3/4 treatment-emergent adverse events included febrile neutropenia', 'composite complete remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C2346682', 'cui_str': 'CPX-351'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",56.0,0.0785846,"The 50 units/m 2 arm had a median OS of 4.3 months, compared with 8.6 and 6.2 months for the 75 and 100 units/m 2 respectively (P = 0.04).","[{'ForeName': 'Ghayas C', 'Initials': 'GC', 'LastName': 'Issa', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lianchun', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Prithviraj', 'Initials': 'P', 'LastName': 'Bose', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Naqvi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Andreeff', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kornblau', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maro', 'Initials': 'M', 'LastName': 'Ohanian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. jorge.cortes@augusta.edu.'}]",Leukemia,['10.1038/s41375-020-0916-8']
993,32535984,Impact of parents' mental-health-related stigma on their adolescent children' response to anti-stigma interventions over 24 months: Secondary exploratory analysis of a randomized controlled trial.,,2020,,"[""parents' mental health-related stigma on their adolescent children's""]",['anti-stigma interventions'],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.193345,,"[{'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sosei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Community Mental Health & Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Neuropsychiatry, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Koike', 'Affiliation': 'Center for Evolutionary Cognitive Sciences, Graduate School of Arts and Sciences, The University of Tokyo, Tokyo, Japan.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13085']
994,32536000,Impact of inferior caval valve implantation on severity of tricuspid regurgitation and right heart function.,"AIMS
Severe tricuspid regurgitation (TR) is a common finding in heart failure patients and associated with increased mortality. New interventional therapeutic options are needed as many heart failure patients are unfit for surgery. The TRICAVAL study compared valve implantation into the inferior vena cava (CAVI) with optimal medical therapy (OMT) in patients with severe TR. Here, we report details on the impact of CAVI on TR severity as well as right heart function and morphology.
METHODS AND RESULTS
We randomized 28 patients with severe TR to CAVI (n = 14) with transfemoral implantation of an Edwards Sapien XT valve into the inferior vena cava or OMT (n = 14). Inclusion and exclusion criteria were based on anatomical and clinical parameters. Echocardiographic measurements were performed at baseline, at the first postoperative day and one, three, and twelve months after randomization. As proof of concept of an effective sealing of the inferior vena cava, we detected a significant decrease in systolic hepatic vein reflux volume (11.0 [6.2-21.9] mL vs 3.5 [0.6-8.5] mL, P = .016) and hepatic vein diameter (11.5 [10.0-14.8] mm vs 10.0 [9.3-11.8] mm, P = .034) at thirty-day follow-up. However, CAVI had no significant impact on TR, cardiac function, and morphology.
CONCLUSIONS
Caval valve implantation significantly reduced systolic reflux into the hepatic veins but was not associated with an improvement in cardiac function, morphology, or TR severity.",2020,"CONCLUSIONS
Caval valve implantation significantly reduced systolic reflux into the hepatic veins but was not associated with an improvement in cardiac function, morphology, or TR severity.","['heart failure patients', 'patients with severe TR', '28 patients with severe TR to CAVI (n\xa0=\xa014) with', 'n\xa0=\xa014']","['valve implantation into the inferior vena cava (CAVI) with optimal medical therapy (OMT', 'inferior caval valve implantation', 'transfemoral implantation of an Edwards Sapien XT valve into the inferior vena cava or OMT']","['Echocardiographic measurements', 'hepatic vein diameter', 'Severe tricuspid regurgitation (TR', 'systolic reflux', 'severity of tricuspid regurgitation and right heart function', 'systolic hepatic vein reflux volume', 'TR, cardiac function, and morphology', 'cardiac function, morphology, or TR severity']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0085979', 'cui_str': 'Genus Cavia'}]","[{'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042458', 'cui_str': 'Inferior vena cava structure'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0152096', 'cui_str': 'Complete trisomy 18 syndrome'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0019155', 'cui_str': 'Structure of hepatic vein'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040961', 'cui_str': 'Tricuspid valve regurgitation'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0225808', 'cui_str': 'Structure of right side of heart'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",28.0,0.0584031,"CONCLUSIONS
Caval valve implantation significantly reduced systolic reflux into the hepatic veins but was not associated with an improvement in cardiac function, morphology, or TR severity.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mattig', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Knebel', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hewing', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Stangl', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Stangl', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Laule', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Henryk', 'Initials': 'H', 'LastName': 'Dreger', 'Affiliation': 'Medizinische Klinik mit Schwerpunkt Kardiologie und Angiologie, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}]","Echocardiography (Mount Kisco, N.Y.)",['10.1111/echo.14760']
995,31764454,Central-Positive Complexes: A Novel Characterization of Ictal Markers Induced During Electroconvulsive Therapy.,"OBJECTIVES
Electroencephalography (EEG) allows monitoring of generalized seizures induced during electroconvulsive therapy (ECT). Scalp EEG recordings show different phases of electroencephalographic ictal activity during ECT seizures, documenting a pattern of seizures that may vary within and across individuals. In this case series, we used 64-electrode high-density EEG recording to detect topographic electroencephalographic changes not typically evident with conventional limited montages commonly used during ECT.
METHODS
The EEG recordings were acquired from 5 participants (24 ECT sessions) during index courses for treatment-resistant depression. Using previously proposed staging criteria, the ictal EEG and simultaneously acquired video were interpreted by an expert reviewer blinded to study treatment parameters.
RESULTS
The EEG recordings of all seizures showed generalized, high-amplitude, central-positive complexes (CPCs), which emerged at the beginning of phase III (polyspike and slow wave activity), with median duration of 47 seconds (interquartile range, 77 seconds), ranging from 14 to 203 seconds. Although individuals showed variability in frequency and amplitude of CPCs, CPCs typically evolved from 4.0 to 1.5 Hz in frequency and decreased in amplitude as the seizure progressed. Elaborating on previously described phases of ECT-induced electrographic seizures, we describe variability in morphology at seizure termination. Initiation of CPCs typically corresponded with clonic movements, but often terminated after motor signs ceased.
CONCLUSIONS
Generalized, high-amplitude, CPCs during ECT are a previously uncharacterized ictal waveform during ECT, which may have important scientific and clinical value. These complexes offer a specific marker for correlating clinical outcomes in ECT and greater understanding of generalized tonic-clonic seizures.",2019,"The EEG recordings of all seizures showed generalized, high-amplitude, central-positive complexes (CPCs), which emerged at the beginning of phase III (polyspike and slow wave activity), with median duration of 47 seconds (interquartile range, 77 seconds), ranging from 14 to 203 seconds.",[],"['Electroencephalography (EEG', 'Central-Positive Complexes', 'electroconvulsive therapy (ECT', '64-electrode high-density EEG recording', 'Electroconvulsive Therapy']",[],[],"[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",[],,0.0591112,"The EEG recordings of all seizures showed generalized, high-amplitude, central-positive complexes (CPCs), which emerged at the beginning of phase III (polyspike and slow wave activity), with median duration of 47 seconds (interquartile range, 77 seconds), ranging from 14 to 203 seconds.","[{'ForeName': 'R Edward', 'Initials': 'RE', 'LastName': 'Hogan', 'Affiliation': 'From the Department of Neurology, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Trammel', 'Affiliation': 'Neuroscience Graduate Program, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Nuri B', 'Initials': 'NB', 'LastName': 'Farber', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Avidan', 'Affiliation': 'Anesthesiology, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Ben Julian A', 'Initials': 'BJA', 'LastName': 'Palanca', 'Affiliation': 'Anesthesiology, Washington University in St. Louis, St. Louis, MO.'}]",The journal of ECT,['10.1097/YCT.0000000000000597']
996,32536587,Effect of Pretreatment and Activation Mode on the Interfacial Adaptation of Nanoceramic Resin Inlay and Self-adhesive Resin Cement.,"OBJECTIVES
The first objective of this study was to determine if the luting material used for resin nanoceramic inlay affects interfacial adaptation. The second was to investigate whether pretreatment and the adhesive curing method before cementation affects interfacial adaptation. The final objective was to compare activation modes of luting material.
METHODS
Class I cavities were prepared on extracted human third molars. Resin nanoceramic inlays were fabricated using Lava Ultimate CAD/CAM block (3 M). For the control groups, inlays were cemented using Panavia V5 (Kuraray Noritake). For the experimental groups, teeth were randomly divided into five experimental groups with four subgroups using different self-adhesive cements (SACs). Cement in Group I was dual-cured without pretreatment. In Group II, the cement was dual-cured after polyacrylic acid treatment of the tooth cavity. In Groups III and IV, the cement was dual-cured after universal dentin adhesive treatment with pre-cure and co-cure methods. In Group V, the inlay was cemented in self-cure mode. After thermocycling, interfacial adaptation at the inlay-tooth interface was measured using swept-source optical coherence tomography (SS-OCT) imaging. Finally, polymerization shrinkage strain of the luting material was measured and compared.
RESULTS
Interfacial adaptation differed depending on the luting material. After application of a universal adhesive, some subgroups showed improved interfacial adaptation. Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
SIGNIFICANCE
Interfacial adaptation for a resin nanoceramic inlay can differ according to the type of SAC and activation mode. For some SACs, application of a universal adhesive before cementation improves interfacial adaptation.",2020,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","['Class', 'Nanoceramic Resin Inlay and Self-adhesive Resin Cement']",['self-adhesive cements (SACs'],"['interfacial adaptation', 'Interfacial adaptation and polymerization shrinkage strain']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0382302', 'cui_str': 'Adhesive cement'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",,0.0172676,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","[{'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Conservative Dentistry, St. Vincent Hospital, College of Medicine, The Catholic University of Korea, 93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, South Korea. Electronic address: han7537@hotmail.com.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Operative Dentistry, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan; Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: shimada.ope@okayama-u.ac.jp.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadr', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of Washington, 1959 NE Pacific St, B162, Seattle, WA, 98195 USA. Electronic address: arsadr@uw.edu.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': 'Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: tagami.ope@tmd.ac.jp.'}, {'ForeName': 'Kee-Yeon', 'Initials': 'KY', 'LastName': 'Kum', 'Affiliation': 'Department of Conservative Dentistry, Dental Research Institute, National Dental Care Center for Persons with Special Needs, Seoul National University Dental Hospital, Seoul National University School of Dentistry, 101 Daehak-ro, Jongno-gu, Seoul, 08030, Republic of Korea. Electronic address: kum6139@snu.ac.kr.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, Oral Science Research Center, College of Dentistry, Yonsei University, #50 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea. Electronic address: sunghopark@yuhs.ac.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.05.005']
997,32548854,S100B and NSE in Cluster Headache - Evidence for Glial Cell Activation?,"OBJECTIVE
Neuronal-specific enolase (NSE) and protein S100B have gained considerable interest as the markers of CNS injury, glial cell activation, and/or blood-brain barrier (BBB) disruption. No studies have investigated NSE and S100B in cluster headache (CH), but these biomarkers could contribute to the understanding of CH.
METHODS
Patients with episodic CH in bout (eCHa), in remission (eCHr), and chronic CH (cCH) were included in this randomized, double-blind, placebo-controlled, 2-way cross-over provocation study carried out at the Danish Headache Center. The primary endpoints included (1) differences of NSE and S100B in between groups (eCHa, eCHr, and cCH) at baseline; (2) differences over time in plasma concentrations of NSE and S100B between patient developing an attack and those who did not; (3) differences in plasma concentrations over time of NSE and S100B between active day and placebo day. Baseline findings were compared to the historical data on migraine patients and healthy controls and presented with means ± SD.
RESULTS
Nine eCHa, 9 eCHr, and 13 cCH patients completed the study and blood samples from 11 CGRP-induced CH attacks were obtained. There were no differences in NSE levels between CH groups at baseline, but CH patients in active disease phase had higher levels compared with 32 migraine patients (9.1 ± 2.2 µg/L vs 6.0 ± 2.2 µg/L, P < .0001) and 6 healthy controls (9.1 ± 2.2 µg/L vs 7.3 ± 2.0 µg/L, P = .007). CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl [-0.26, 3.85], P = .061). At baseline S100B levels in eCHa patients were higher compared to cCH patients (0.06 ± 0.02 µg/L vs 0.04 ± 0.02 µg/L, P = .018). Infusion of CGRP and CGRP-induced attacks did not change S100B levels. Apart from induced CH-attacks no other adverse events were noted.
CONCLUSIONS
At baseline eCHa patients had higher S100B plasma levels than cCH patients and there was a slight, however not significant, NSE increase in response to CGRP-induced CH attack. Our findings suggest a possible role of an ictal activation of glial cells in CH pathophysiology, but further studies are warranted.",2020,"CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl","['Patients with episodic CH in bout (eCHa), in remission (eCHr), and chronic CH (cCH', 'Nine eCHa, 9 eCHr, and 13 cCH patients']","['CGRP and CGRP', 'CGRP-infusion', 'placebo']","['S100B plasma levels', 'NSE', 'CH attack', 'adverse events', 'NSE and S100B in between groups (eCHa, eCHr, and cCH) at baseline', 'NSE levels', 'plasma concentrations of NSE and S100B', 'plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031691', 'cui_str': 'Enolase'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.116189,"CGRP-infusion caused no NSE changes and, but a slight, non-significant, increase in NSE was seen in patients who reported a CGRP-induced CH attack (2.39 µg/L, 95% Cl","[{'ForeName': 'Agneta H', 'Initials': 'AH', 'LastName': 'Snoer', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Luise H', 'Initials': 'ALH', 'LastName': 'Vollesen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus Paulin', 'Initials': 'RP', 'LastName': 'Beske', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hoffmann', 'Affiliation': ""Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Niklas R', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Martinussen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet-Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Headache,['10.1111/head.13864']
998,32544109,Effects of Dry Needling Technique Into Trigger Points of the Sternocleidomastoid Muscle in Migraine Headache: A Randomized Controlled Trial.,"OBJECTIVE
The study aimed to investigate the effect of dry needling into trigger points of the sternocleidomastoid muscle in migraine headache patients.
DESIGN
Forty subjects with a migraine headache, originating from myofacial trigger points into the sternocleidomastoid muscle (20 subjects in dry needling group and 20 subjects in control group) volunteered to participate in this study. The subjects in the treatment group received three sessions of dry needling in the myofascial trigger point region. Headache frequency, headache intensity, headache duration, drug consumption, muscle thickness, pressure pain threshold, and cervical range of motion were assessed before, immediately after intervention, and at 1-mo follow-up period. In addition, this article was extracted from Iranian Register of Clinical Trials Number IRCT20171219037956N1.
RESULTS
The experimental group showed significant reduction in the headache parameters immediately after the intervention and at 1-mo follow-up, as compared with the control group. The pressure pain threshold of sternocleidomastoid muscle, cervical range of motion, and muscle thickness significantly increased in the dry needling group in comparison with the control group (P < 0.001).
CONCLUSIONS
The application of dry needling technique caused an improvement in symptoms of migraine patients. Therefore, this technique may be prescribed for treating migraine patients with myofacial trigger points in the sternocleidomastoid muscle.",2020,"The PPT of SCM muscle, cervical range of motion, and muscle thickness significantly increased in the DN group in comparison to the control group (p < 0.001).
","['migraine headache patients', 'Forty subjects with a migraine headache, originating from myofacial trigger points into the sternocleidomastoid (SCM) muscle (20 subjects in DN group and 20 subjects in control group) volunteered to participate in this study', 'migraine headache', 'migraine patients']","['dry needling (DN', 'dry needling technique', 'dry needling']","['headache parameters', 'Headache frequency, headache intensity, headache duration, drug consumption, muscle thickness, pressure pain threshold (PPT), and cervical range of motion', 'PPT of SCM muscle, cervical range of motion, and muscle thickness']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0224153', 'cui_str': 'Structure of sternocleidomastoid muscle'}]",40.0,0.0137744,"The PPT of SCM muscle, cervical range of motion, and muscle thickness significantly increased in the DN group in comparison to the control group (p < 0.001).
","[{'ForeName': 'Tahere', 'Initials': 'T', 'LastName': 'Rezaeian', 'Affiliation': 'From the Physiotherapy Department, Social Welfare and Rehabilitation Sciences University, Tehran, Iran (TR); Physiotherapy Department and Research Center on Aging, Social Welfare and Rehabilitation Sciences University, Tehran, Iran (ZM); Physiotherapy Department, North Georgia University, Dahlonega, Georgia (MRN); Social Determinants of Health Research Center, Social Welfare and Rehabilitation Sciences University, Tehran, Iran (MN); and Clinical Sciences Department & Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran (FS).'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': ''}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': ''}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Noroozi', 'Affiliation': ''}, {'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Sajedi', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001504']
999,32558314,Four-day plaque regrowth evaluation of a peptide chewing gum in a double-blind randomized clinical trial.,"OBJECTIVE
Antimicrobial peptide, KSL-W, formulated as an antiplaque chewing gum (APCG), was tested to evaluate the dental plaque inhibition activity and safety in an IRB approved and FDA regulated 4-day plaque regrowth clinical study.
METHODS
This Phase 2 two-armed placebo-controlled, double blind, randomized (1:1), multiple dose, and single-center study was evaluated in a proof of concept for the APCG containing 30 mg antimicrobial peptide KSL-W. Twenty six generally healthy subjects were consented and randomized into the study. The subjects were administered a dose three times per day for four treatment days following a complete dental prophylaxis. Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial. Twelve to 16 hr prior to the baseline visit, the subjects were to abstain from oral hygiene care. The Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams were obtained at both Day 0 and Day 4.
RESULTS
All randomized study subjects that received either APCG or placebo gum completed the study with no significant adverse events recorded. The APCG significantly inhibited the regrowth of dental plaque over the course of 4 days. The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003.
CONCLUSION
Considering the limited sample size, the proof of concept analysis in this Phase 2 study confirmed that APCG is effective against dental plaque formation and safe for human use. (ClinicalTrials.gov Study ID# NCT02864901).",2020,"The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003.
","['W. Twenty six generally healthy subjects', 'Participants were prohibited from conducting oral hygiene care (teeth brushing, flossing, and/or mouth wash rinse) for the duration of the trial']","['APCG', 'APCG or placebo', 'peptide chewing gum', 'APCG containing 30\u2009mg antimicrobial peptide KSL', 'placebo']","['QHT', 'Quigley-Hein Turesky plaque index (QHT) score and the oral soft tissue clinical exams', 'regrowth of dental plaque']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0447424', 'cui_str': 'Oral soft tissues structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]",26.0,0.308301,"The whole mouth data demonstrated a difference in the QHT between the APCG and the placebo gum of 1.14 (SE = 0.27) and 95% confidence bounds of 0.58, 1.70 with a two-tailed P value of .0003.
","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kirkwood', 'Affiliation': 'Dental and Craniofacial Trauma, US Army Institute of Surgical Research, San Antonio, Texas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'ClinSmart LLC, Newton, Pennsylvania.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, Indiana.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Milleman', 'Affiliation': 'Salus Research, Inc., Fort Wayne, Indiana.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Leung', 'Affiliation': 'Dental and Craniofacial Trauma, US Army Institute of Surgical Research, San Antonio, Texas.'}]",Clinical and experimental dental research,['10.1002/cre2.275']
1000,32557843,Residual Symptoms of Posttraumatic Stress Disorder and Alcohol Use Disorder Following Integrated Exposure Treatment Versus Coping Skills Treatment.,"Although some studies have demonstrated residual symptoms in patients who have participated in posttraumatic stress disorder (PTSD) treatment, no studies to date have assessed residual PTSD symptoms following treatment for comorbid alcohol use disorder (AUD) and PTSD (PTSD/AUD). We examined residual symptoms of PTSD and AUD in 73 veterans with PTSD/AUD who completed a posttreatment assessment after being randomized to receive either Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) or Seeking Safety (SS). We used logistic regression to identify differences (a) in residual PTSD and AUD symptoms among participants randomized to COPE versus SS and (b) among those with versus without a posttreatment PTSD/AUD diagnosis within both treatment conditions. Participants randomized to SS were more likely to report persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping, ORs = 3.74-6.21. There were no differences between COPE and SS regarding the likelihood of persistent AUD symptoms. Participants without a posttreatment PTSD diagnosis had lower conditional probabilities of most symptoms, although exaggerated startle, OR = 0.71, and irritability/aggression, OR = 0.58, were most likely to persist. Participants without a posttreatment AUD diagnosis had lower conditional probabilities of most symptoms, although withdrawal, OR = 0.21; unsuccessful quit attempts, OR = 0.04; and higher intake, OR = 0.01, were most likely to persist. Findings indicate hyperarousal may warrant additional intervention following PTSD treatment. Residual AUD symptoms may relate to the enduring nature of some AUD symptoms rather than a lack of treatment efficacy.",2020,"Participants randomized to SS were more likely to report persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping, ORs = 3.74-6.21.","['patients who have participated in posttraumatic stress disorder (PTSD', '73 veterans with PTSD/AUD who completed a posttreatment assessment after being randomized to receive either']","['Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) or Seeking Safety (SS', 'Integrated Exposure Treatment Versus Coping Skills Treatment', 'SS']","['persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping', 'conditional probabilities of most symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}]","[{'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",73.0,0.0172857,"Participants randomized to SS were more likely to report persistent avoidance, inability to experience positive emotions, hypervigilance, difficulty concentrating, and difficulty sleeping, ORs = 3.74-6.21.","[{'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Tripp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Angkaw', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Paula P', 'Initials': 'PP', 'LastName': 'Schnurr', 'Affiliation': 'National Center for PTSD, White River Junction, Vermont, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Trim', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Haller', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Brittany C', 'Initials': 'BC', 'LastName': 'Davis', 'Affiliation': ""James A. Haley Veteran's Hospital, Tampa, Florida, USA.""}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}]",Journal of traumatic stress,['10.1002/jts.22552']
1001,32557384,The Influence of Laparoscopic Sleeve Gastrectomy on Body Composition and Fat Distribution in Obese Caucasian Men and Women.,"BACKGROUND
The aim of the study was to assess changes in body composition in patients subjected to laparoscopic sleeve gastrectomy (LSG).
METHODS
Changes in body composition following LSG were determined in a group of 155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA). Whole body fat mass (FM) and lean body mass (LBM) were determined, and abdominal fat mass (AbdF) was assessed within the region extending from the top of the pubic bone up to the line between 12th thoracic and 1st lumbar vertebras.
RESULTS
Over the period of 12 months following LSG, body mass index decreased by 28.2 ± 9.0% (p < 0.001). The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001). AbdF decreased from 13.2 ± 3.1 to 8.2 ± 2.7 kg (p < 0.001), but abdominal fat to total fat mass ratio increased from 24.9 ± 4.7 to 28.0 ± 5.8% (p < 0.001). The loss of AbdF was more pronounced in men than in women. The rate of FM loss was attenuated with patients' age.
CONCLUSIONS
Over the period of 12 months following LSG, the reduction of FM was more than twice as much as decrease of LBM. The loss of AbdF was slower than a loss of peripheral subcutaneous fat.",2020,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"['patients subjected to', '155 patients with obesity (117 women and 38 men), with dual-energy X-ray absorptiometry (DXA', 'Obese Caucasian Men and Women']","['Laparoscopic Sleeve Gastrectomy', 'laparoscopic sleeve gastrectomy (LSG']","['rate of FM loss', 'FM', 'body mass index', 'reduction of body weight', 'body composition', 'abdominal fat to total fat mass ratio', 'LBM', 'loss of AbdF', 'Body Composition and Fat Distribution', 'Whole body fat mass (FM) and lean body mass (LBM', 'reduction of FM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264679', 'cui_str': 'Mass ratio'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",155.0,0.0416692,The reduction of body weight by 35.4 ± 12.6 kg (p < 0.001) was the result of a decrease in FM by 23.9 ± 8.9 kg (p < 0.001) and LBM by 10.5 ± 3.8 kg (p < 0.001).,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Tałałaj', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland. marektalalaj@op.pl.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Bogołowska-Stieblich', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wąsowski', 'Affiliation': 'Department of Geriatrics, Internal Medicine and Metabolic Bone Diseases, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Binda', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Jaworski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Wrzosek', 'Affiliation': 'Department of Biochemistry and Pharmacogenomics, Faculty of Pharmacy, Medical University of Warsaw, Banacha 1, 02-097, Warsaw, Poland.'}, {'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Tarnowski', 'Affiliation': 'Department of General, Oncological and Digestive Tract Surgery, Centre of Postgraduate Medical Education, Orłowski Hospital, Czerniakowska 231, 00-416, Warsaw, Poland.'}]",Obesity surgery,['10.1007/s11695-020-04766-z']
1002,32558226,Use of a Bluetooth tablet-based technology to improve outcomes in lung transplantation: A pilot study.,"The impact of remote patient monitoring platforms to support the postoperative care of solid organ transplant recipients is evolving. In an observational pilot study, 28 lung transplant recipients were enrolled in a novel postdischarge home monitoring program and compared to 28 matched controls during a 2-year period. Primary endpoints included hospital readmissions and total days readmitted. Secondary endpoints were survival and inflation-adjusted hospital readmission charges. In univariate analyses, monitoring was associated with reduced readmissions (incidence rate ratio [IRR]: 0.56; 95% confidence interval [CI]: 0.41-0.76; P < .001), days readmitted (IRR: 0.46; 95% CI: 0.42-0.51; P < .001), and hospital charges (IRR: 0.52; 95% CI: 0.51-0.54; P < .001). Multivariate analyses also showed that remote monitoring was associated with lower incidence of readmission (IRR: 0.38; 95% CI: 0.23-0.63; P < .001), days readmitted (IRR: 0.14; 95% CI: 0.05-0.37; P < .001), and readmission charges (IRR: 0.11; 95% CI: 0.03-0.46; P = .002). There were 2 deaths among monitored patients compared to 6 for controls; however, this difference was not significant. This pilot study in lung transplant recipients suggests that supplementing postdischarge care with remote monitoring may be useful in preventing readmissions, reducing subsequent inpatient days, and controlling hospital charges. A multicenter, randomized control trial should be conducted to validate these findings.",2020,"In univariate analyses, monitoring was associated with reduced readmissions (IRR: 0.56; 95% CI: 0.41 - 0.76; p < 0.001), days readmitted (IRR: 0.46; 95% CI: 0.42 - 0.51; p < 0.001), and hospital charges (IRR: 0.52; 95% CI: 0.51 - 0.54; p < 0.001).","['lung transplant recipients', '28 lung transplant recipients were enrolled in a novel post-discharge home monitoring program and compared to 28 matched controls during a two-year period', 'lung transplantation']",['Bluetooth tablet-based technology'],"['hospital charges', 'survival and inflation-adjusted hospital readmission charges', 'incidence of readmission', 'hospital readmissions and total days readmitted', 'readmission charges']","[{'cui': 'C0024128', 'cui_str': 'Transplant of lung'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0206175', 'cui_str': 'Charge, Hospital'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0472527,"In univariate analyses, monitoring was associated with reduced readmissions (IRR: 0.56; 95% CI: 0.41 - 0.76; p < 0.001), days readmitted (IRR: 0.46; 95% CI: 0.42 - 0.51; p < 0.001), and hospital charges (IRR: 0.52; 95% CI: 0.51 - 0.54; p < 0.001).","[{'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Schenkel', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Barr', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'McCloskey', 'Affiliation': 'ActiCare Health, Livermore, California, USA.'}, {'ForeName': 'Tammie', 'Initials': 'T', 'LastName': 'Possemato', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': ""O'Conner"", 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Roya', 'Initials': 'R', 'LastName': 'Sadeghi', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bembi', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Duong', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jaynita', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Keck Medical Center, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Hackmann', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Sivagini', 'Initials': 'S', 'LastName': 'Ganesh', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Southern California, Los Angeles, California, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16154']
1003,32559003,Evaluation and comparison of histologic changes and implant survival in extraction sites immediately grafted with two different xenografts: A randomized clinical pilot study.,"OBJECTIVES
The purpose of this prospective, single-center randomized pilot study was to histologically evaluate and compare vital bone development in premolar and molar-extraction sites grafted with two different bovine-derived xenografts. The secondary outcome of interest was implant survival in the grafted sites.
MATERIALS AND METHODS
Adult patients in need of at least two tooth extractions were enrolled. A paired design was used; each patient received at least one of each type of graft at different sites. Each extraction site was randomized to one of two xenograft treatment groups. A resorbable membrane was always placed, and primary intention soft tissue closure was achieved. Four months later, implants were placed and a trephine drill was used to remove bone cores for histologic and histomorphometric analysis.
RESULTS
Sixteen patients with 40 extraction sites were enrolled; 20 sites were grafted with one type of xenograft and 20 with another. Mean patient age was 53.5 years, and 65% of patients were male. Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4% and 32.4%, p = .76). Cumulative implant survival was 97.5% at the 24-month follow-up visit.
CONCLUSION
Within the limitations of this pilot study, no statistically significant differences in new bone growth between sites grafted with two different types of xenograft were found. Both graft materials promoted the formation of new bone and provided osseous support for implant placement after socket grafting.",2020,"Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4 % and 32.4 %, p=0.76).","['Mean patient age was 53.5 years, and 65% of patients were male', 'Sixteen patients with 40 extraction sites were enrolled; 20 sites were grafted with one type of xenograft and 20 with another', 'Adult patients in need of at least 2 tooth extractions were enrolled', 'premolar and molar extraction sites grafted with 2 different bovine-derived xenografts']",[],"['new bone growth', 'Histologic Changes and Implant Survival', 'implant survival', 'Cumulative implant survival', 'mean value of percentage of new bone formation']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}]",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}]",16.0,0.0481422,"Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4 % and 32.4 %, p=0.76).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Sivolella', 'Affiliation': 'Department of Neurosciences, Dentistry Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Botticelli', 'Affiliation': 'ARDEC Academy, Ariminum Odontologica SRL, Rimini, Italy.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, Biological and Diagnostic Sciences, School of Dentistry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'Department of Neurosciences, Dentistry Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Eriberto', 'Initials': 'E', 'LastName': 'Bressan', 'Affiliation': 'Department of Neurosciences, Dentistry Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, Biological and Diagnostic Sciences, School of Dentistry, University of Minnesota, Minneapolis, MN, USA.'}]",Clinical oral implants research,['10.1111/clr.13626']
1004,32558199,Avoidance of CNI and steroids using belatacept-Results of the Clinical Trials in Organ Transplantation 16 trial.,"Immunosuppression devoid of corticosteroids has been investigated to avoid long-term comorbidities. Likewise, alternatives to calcineurin inhibitors have been investigated as a strategy to improve long-term kidney function following transplanion. Costimulatory blockade strategies that include corticosteroids have recently shown promise, despite their higher rates of early acute rejection. We designed a randomized clinical trial utilizing depletional induction therapy to mitigate early rejection risk while limiting calcineurin inhibitors and corticosteroids. This trial, Clinical Trials in Organ Transplantation 16 (CTOT-16), sought to evaluate novel belatacept-based strategies employing tacrolimus and corticosteroid avoidance. Sixty-nine kidney transplant recipients were randomized from 4 US transplant centers comparing a control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to 2 arms using maintenance belatacept. There were no graft losses but there were 2 deaths in the control group. However, the trial was halted early because of rejection in the belatacept treatment groups. Serious adverse events were similar across groups. Although rejection was not uniform in the belatacept maintenance therapy groups, the frequency of rejection limits the practical implementation of this strategy to avoid both calcineurin inhibitors and corticosteroids at this time.",2020,Serious adverse events were similar across groups.,['69 kidney transplant recipients'],"['depletional induction therapy', 'control group of with rabbit antithymocyte globulin (rATG) induction, rapid steroid taper, and maintenance mycophenolate and tacrolimus, to two arms using maintenance belatacept', 'tacrolimus and corticosteroid avoidance', 'calcineurin inhibitors and corticosteroids']","['graft losses', 'Serious adverse events']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1619962', 'cui_str': 'belatacept'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}]","[{'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",69.0,0.102752,Serious adverse events were similar across groups.,"[{'ForeName': 'Roslyn B', 'Initials': 'RB', 'LastName': 'Mannon', 'Affiliation': 'Department of Medicine, Division of Nephrology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'Rho Inc, Durham, North Carolina, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Stock', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Alton B', 'Initials': 'AB', 'LastName': 'Farris', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Watson', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Morrison', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Minnie', 'Initials': 'M', 'LastName': 'Sarwal', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sigdel', 'Affiliation': 'Department of Surgery, Division of Transplantation, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Bridges', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robien', 'Affiliation': 'Transplantation Branch, National Institute Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Newell', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Larsen', 'Affiliation': 'Emory Transplant Center, Emory University School of Medicine, Atlanta, Georgia, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16152']
1005,32553489,"High Prevalence of Multidrug-Resistant Organism Colonization in 28 Nursing Homes: An ""Iceberg Effect"".","OBJECTIVE
Determine the prevalence of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp. (VRE), extended-spectrum beta-lactamase producing organisms (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE) among residents and in the environment of nursing homes (NHs).
DESIGN
Point prevalence sampling of residents and environmental sampling of high-touch objects in resident rooms and common areas.
SETTING
Twenty-eight NHs in Southern California from 2016 to 2017.
PARTICIPANTS
NH participants in Project PROTECT, a cluster-randomized trial of enhanced bathing and decolonization vs routine care.
METHODS
Fifty residents were randomly sampled per NH. Twenty objects were sampled, including 5 common room objects plus 5 objects in each of 3 rooms (ambulatory, total care, and dementia care residents).
RESULTS
A total of 2797 swabs were obtained from 1400 residents in 28 NHs. Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%). Median prevalence of specific MDROs were as follows: MRSA, 36% (range: 20%-54%); ESBL, 16% (range: 2%-34%); VRE, 5% (range: 0%-30%); and CRE, 0% (range: 0%-8%). A median of 45% of residents (range: 24%-67%) harbored an MDRO without a known MDRO history. Environmental MDRO contamination was found in 74% of resident rooms and 93% of common areas.
CONCLUSIONS AND IMPLICATIONS
In more than half of the NHs, more than 50% of residents were colonized with MDROs of clinical and public health significance, most commonly MRSA and ESBL. Additionally, the vast majority of resident rooms and common areas were MDRO contaminated. The unknown submerged portion of the iceberg of MDRO carriers in NHs may warrant changes to infection prevention and control practices, particularly high-fidelity adoption of universal strategies such as hand hygiene, environmental cleaning, and decolonization.",2020,Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%).,"['residents and environmental sampling of high-touch objects in resident rooms and common areas', '28 Nursing Homes', 'A total of 2797 swabs were obtained from 1400 residents in 28 NHs', 'NH participants', 'Fifty residents were randomly sampled per NH', 'Twenty-eight NHs in Southern California from 2016 to\xa02017', 'Twenty objects were sampled, including 5 common room objects plus 5 objects in each of 3 rooms (ambulatory, total care, and dementia care residents']","['vancomycin-resistant Enterococcus spp', 'enhanced bathing and decolonization vs routine care', 'VRE), extended-spectrum beta-lactamase producing organisms (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE']","['Environmental MDRO contamination', 'Median prevalence of specific MDROs', 'Median prevalence of multidrug-resistant organism (MDRO) carriage per NH']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C4039163', 'cui_str': 'Carbapenem resistant Enterobacteriaceae'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",2797.0,0.115846,Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%).,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McKinnell', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA; Los Angeles County Department of Public Health, Healthcare Outreach Unit, Los Angeles, CA, USA; Expert Stewardship, Newport, CA, USA. Electronic address: Dr.McKinnell@gmail.com.'}, {'ForeName': 'Loren G', 'Initials': 'LG', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Raveena D', 'Initials': 'RD', 'LastName': 'Singh', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Gussin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kleinman', 'Affiliation': 'University of Massachusetts Amherst School of Public Health and Health Sciences, Amherst, MA, USA.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Bryn', 'Initials': 'B', 'LastName': 'Laurner', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Tabitha D', 'Initials': 'TD', 'LastName': 'Catuna', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Heim', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Raheeb', 'Initials': 'R', 'LastName': 'Saavedra', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Felix', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Estevez', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tchakalian', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ceja', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Miner', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Aura', 'Initials': 'A', 'LastName': 'Hurtado', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Ratharo', 'Initials': 'R', 'LastName': 'Hean', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Varasteh', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Robinson', 'Affiliation': 'Expert Stewardship, Newport, CA, USA; Hoag Hospital, Newport, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Tam', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California Irvine, Orange, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tjoa', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Custodio', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Cassiana E', 'Initials': 'CE', 'LastName': 'Bittencourt', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Kaye D', 'Initials': 'KD', 'LastName': 'Evans', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI, USA; Center of Innovation in Long-Term Services and Supports, Veterans Affairs Medical Center, Providence VA Medical Center, Providence, RI, USA; Center for Long-Term Care Quality and Innovation, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McConeghy', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI, USA; Center of Innovation in Long-Term Services and Supports, Veterans Affairs Medical Center, Providence VA Medical Center, Providence, RI, USA; Center for Long-Term Care Quality and Innovation, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Weinstein', 'Affiliation': 'Cook County Health and Hospitals System, Chicago, IL, USA; Department of Medicine, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Hayden', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Nimalie D', 'Initials': 'ND', 'LastName': 'Stone', 'Affiliation': 'Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Steinberg', 'Affiliation': 'California Association of Long Term Care Medicine, Santa Clarita, CA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Beecham', 'Affiliation': 'The National Association of Directors of Nursing Administration in Long Term Care, Springdale, OH, USA.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Montgomery', 'Affiliation': 'California Association of Health Facilities, Sacramento, CA, USA.'}, {'ForeName': 'Walters', 'Initials': 'W', 'LastName': 'DeAnn', 'Affiliation': 'California Association of Health Facilities, Sacramento, CA, USA.'}, {'ForeName': 'Ellena M', 'Initials': 'EM', 'LastName': 'Peterson', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA, USA; Department of Medicine, Health Policy Research Institute, University of California Irvine School of Medicine, Irvine, CA, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.04.007']
1006,32553888,Effect of practical hyperoxic high-intensity interval training on exercise performance.,"This study investigated the effect of a practical hyperoxic high-intensity interval training (HIIT) on aerobic and anaerobic exercise capacity. Sixteen male athletes were randomized into 2 groups: normoxic HIIT (NHIIT, n = 8) group or hyperoxic HIIT (HHIIT, n = 8) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia. All training sessions were performed until exhaustion. Participants performed maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests before and after the training period. Maximal oxygen uptake (P < 0.01) increased significantly in both groups. Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01). Mean power output during maximal exercise increased significantly only in the HHIIT group (P = 0.02). This study demonstrated that a practical hyperoxic HHIIT might be effective for improving aerobic capacity and anaerobic performance.",2020,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01).,['Sixteen male athletes'],"['normoxic HIIT (NHIIT, n\u2009=\u20098) group or hyperoxic HIIT (HHIIT, n\u2009=\u20098) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia', 'maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests', 'practical hyperoxic high-intensity interval training', 'practical hyperoxic high-intensity interval training (HIIT']","['Mean power output during maximal exercise', 'Blood lactate curve during submaximal exercise', 'Maximal oxygen uptake', 'aerobic capacity and anaerobic performance', 'aerobic and anaerobic exercise capacity', 'exercise performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",16.0,0.0253253,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01).,"[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, 101-2 Yagotohonmachi, Showa-ku, Nagoya, 466-8666, Japan; Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan. Electronic address: kon.michihiro@gmail.com.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nakagaki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan; Department of Sports Sciences, Yamanashi Gakuin University, 2-4-5 Sakaori, Kofu, Yamanashi, 400-8575, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Ebi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103481']
1007,32554072,Downregulating the P2X3 receptor in the carotid body to reduce blood pressure via acoustic gene delivery in canines.,"The purinergic P2X3 receptor in the carotid body (CB) is considered a new target for treating hypertension, although approaches for targeted regulating P2X3 receptor expression are lacking. Here, we explored the feasibility of targeted P2X3 receptor down-regulation in CBs by localized low-intensity focused ultrasound (LIFU)-mediated gene delivery to reduce the blood pressure. Thirty-two Kunming canines were randomly assigned to the treatment group (n = 14), negative control group (n = 10), LIFU + cationic microbubbles group (n = 4), and LIFU-only group (n = 4). Plasmid-loaded cationic microbubbles were injected and bilateral CBs were irradiated with a LIFU-based transducer. Flow cytometry showed that 33.15% of transfected cells expressed the green fluorescent protein reporter gene. T7 endonuclease I assays showed an insertion-deletion rate of 8.30%. The P2X3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group. Mean systolic (152.5 ± 3.0 vs 138.0 ± 2.9 mm Hg, P = 0.003) and diastolic (97.8 ± 1.5 vs 87.2 ± 2.3 mm Hg, P= 0.002) blood pressures reduced on day 14 in the treatment group, compared with the baseline values, whereas no effects were observed with LIFU treatment or cationic microbubbles injection alone. Canines treated with this strategy exhibited no local or systemic adverse events. Thus, LIFU-mediated gene delivery to CBs successfully modulated CB function and reduced blood pressure in a canine model, suggesting a new possibility for treating hypertension and further clinical translation.",2021,"The P2 × 3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group.",['Thirty-two Kunming canines'],"['negative control group (n\u202f=\u202f10), LIFU\u202f+\u202fcationic microbubbles group (n\u202f=\u202f4), and LIFU-only group']","['insertion-deletion rate', 'blood pressure', 'Mean systolic', 'local or systemic adverse events', 'blood pressures', 'protein-expression levels in CBs']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1258018', 'cui_str': 'Microbubbles'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1956002', 'cui_str': 'Insertion-Deletion Mutation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0504845,"The P2 × 3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group.","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ruiyu', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lingjiao', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Chongqing Key Laboratory of Ultrasound Molecular Imaging, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Chongqing Key Laboratory of Ultrasound Molecular Imaging, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Dichuan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Shunkang', 'Initials': 'S', 'LastName': 'Rong', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Que', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China; Institute of Ultrasound Imaging, Department of Ultrasound, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. Electronic address: huangjing@cqmu.edu.cn.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.06.005']
1008,32551730,"Prequestions enhance learning, but only when they are remembered.","Answering prequestions benefits learning, but this benefit is mostly specific to material that was relevant to the prequestions (prequestioned material) and does not extend to other, nonprequestioned material. The current study examined whether this specific benefit is due to selective processing of prequestioned information during a learning experience. In 4 experiments, participants were assigned to a prequestion group or control group before viewing a 30-min video lecture. In Experiment 2, participants were instructed to take notes on information they thought was important during the video; in Experiment 3, the prequestion group was instructed to write down the answers to the prequestions; and in Experiment 4, the prequestion group was given the prequestions and instructed to answer them while viewing the video. On a later posttest in all experiments, the prequestion group outperformed the control group, but only for prequestioned material. Further, this benefit only occurred when the prequestion group successfully discovered the answers to the prequestions during the video by writing them down (Experiments 2 and 3) or circling them (Experiment 4). These results suggest that prequestion benefits depend on the degree to which participants can successfully notice and discover the answers to the prequestioned material during a video lecture. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"On a later posttest in all experiments, the prequestion group outperformed the control group, but only for prequestioned material.",[],"['prequestion group or control group before viewing a 30-min video lecture', 'prequestion group was given the prequestions and instructed to answer them while viewing the video']",[],[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",[],,0.0163468,"On a later posttest in all experiments, the prequestion group outperformed the control group, but only for prequestioned material.","[{'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'St Hilaire', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Shana K', 'Initials': 'SK', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000296']
1009,32559278,Diet Quality and Associations with Food Security among Women Eligible for Indiana Supplemental Nutrition Assistance Program-Education.,"BACKGROUND
The diet quality among adults receiving nutrition education lessons through Supplemental Nutrition Assistance Program-Education (SNAP-Ed) is currently unknown.
OBJECTIVES
The objectives of this study were to characterize the diet quality of Indiana SNAP-Ed-eligible women; estimate their mean usual intake of fruits, vegetables, dairy, and whole grains compared to Dietary Guidelines for Americans (DGA) recommendations; and determine if these dietary outcomes differed by food security status.
METHODS
SNAP-Ed paraprofessionals recruited participants from August 2015 to May 2016 for this secondary analysis of cross-sectional data collected as the baseline assessment for a randomized controlled trial. Participants were SNAP-Ed-eligible women aged ≥18 y interested in nutrition education lessons. Dietary outcomes were assessed by one or two 24-h dietary recalls. The Healthy Eating Index (HEI)-2010 was used to characterize diet quality. Mean usual intake of food groups was estimated using the National Cancer Institute Method. Food security status was classified using the US Household Food Security Survey Module. Data were analyzed in October 2019.
RESULTS
Mean ± SEM HEI-2010 total score was 42 ± 0.9 for the study sample. Mean ± SE usual intake of servings of fruits (0.61 ± 0.08 cups [144.32 ± 18.93 mL]), vegetables [1.4 ± 0.10 cups (331.2 ± 23.66 mL)], dairy [1.5 ± 0.11 cups (354.88 ± 26.02 mL)], and whole grains [0.48 ± 0.06 ounces (13.61 ± 1.70 g)] did not differ by food security subgroup. Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01). Mean HEI-2010 component scores were 1.1 ± 0.5 points higher for whole grain (P = 0.01) and 1.0 ± 0.5 points higher for dairy (P = 0.05) in the food-secure than in the food-insecure subgroup. The proportions of the study sample not meeting the DGA recommendations for food group intake were ≥85% for both food-secure and -insecure subgroups.
CONCLUSIONS
Indiana SNAP-Ed-eligible women reported poor diet quality, highlighting their need for nutrition interventions aiming to improve food security and diet as per DGA recommendations in low-income populations.",2020,Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01).,"['Women Eligible for Indiana Supplemental Nutrition Assistance Program-Education', 'Participants were SNAP-Ed-eligible women aged ≥18 y interested in nutrition education lessons', 'SNAP-Ed paraprofessionals recruited participants from August 2015 to May 2016 for this secondary analysis of cross-sectional data collected as the baseline assessment for a randomized controlled trial', 'Indiana SNAP-Ed-eligible women', 'adults receiving nutrition education lessons']",[],"['Mean HEI-2010 total score', 'Mean HEI-2010 component scores', 'Healthy Eating Index', 'Mean\xa0±\xa0SEM HEI-2010 total score', 'Mean\xa0±\xa0SE usual intake of servings of fruits']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021206', 'cui_str': 'Indiana'}, {'cui': 'C3494397', 'cui_str': 'SNAP Program'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}]",,0.0751539,Mean HEI-2010 total score was significantly higher by 4.8 ± 2.0 points for the food-secure than for the food-insecure subgroup (P = 0.01).,"[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Rivera', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Maulding', 'Affiliation': 'Department of Nutrition and Dietetics, Eastern Illinois University, Charleston, IL, USA.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Tooze', 'Affiliation': 'School of Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Breanne N', 'Initials': 'BN', 'LastName': 'Wright', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Regan L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Eicher-Miller', 'Affiliation': 'Department of Nutrition Science, Purdue University, West Lafayette, IN, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa171']
1010,32559515,Fampridine-induced changes in walking kinetics are associated with clinical improvements in patients with multiple sclerosis.,"Gait dysfunction is common in patients with multiple sclerosis (PwMS). Treatment with prolonged-release fampridine (PR-fampridine) improves walking ability in some PwMS. Associated fampridine-induced changes in the walking pattern are still poorly understood but may provide a better understanding of the mechanisms underlying the beneficial drug effects. 61 PwMS were treated with PR-fampridine in a randomized, monocentric, double-blind and placebo-controlled clinical trial with crossover design (FAMPKIN). Drug-induced improvements in walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT) were quantified. In this sub-study of the FAMPKIN trial, fampridine-induced changes in kinetic gait patterns were analyzed by pressure-based foot print analysis during treadmill walking. Vertical ground reaction forces were analyzed during different gait phases. Kinetic data of 44 PwMS was eligible for analysis. During double-blind treatment with PR-fampridine, patients performed significantly better in the T25FW and 6MWT than during placebo treatment (p < 0.0001 for both). At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo. However, we found relevant changes of walking kinetics regarding forces during loading, single limb and pre-swing phase in a patient sub-group (n = 8). Interestingly, this sub-group demonstrated superior responsiveness to PR-fampridine in the clinical walking tests compared to those patients without any fampridine-induced changes in kinetics (n = 36). Our results demonstrate fampridine-induced changes in gait kinetics in a sub-group of PwMS. These gait pattern changes were accompanied by improved clinical walking performance under PR-fampridine. These results shed some light on the biomechanical changes in walking patterns underlying enhanced fampridine-induced gait performance.",2020,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","['patients with multiple sclerosis', 'patients with multiple sclerosis (PwMS']","['PR-fampridine', 'prolonged-release fampridine (PR-fampridine', 'placebo']","['clinical walking performance', 'Vertical ground reaction forces', 'walking kinetics', 'gait kinetics', 'Gait dysfunction', 'walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT', 'kinetic gait patterns', 'T25FW and 6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",61.0,0.124543,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lörincz', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sutter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Linnebank', 'Affiliation': 'Department of Neurology, University Witten/Herdecke and Evangelische Kliniken Gelsenkirchen, Munckelstraße 32, 45879 Gelsenkirchen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zörner', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Filli', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland; Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland; Swiss Center for clinical Movement Analysis (SCMA), Balgrist Campus AG, Lengghalde 5, 8008 Zurich, Switzerland. Electronic address: linard.filli@balgrist.ch.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116978']
1011,32564493,Quilting suture versus conventional closure in prevention of seroma after total mastectomy and axillary dissection in breast cancer patients.,"BACKGROUND
Total mastectomy and axillary dissection is a common procedure for breast cancer patients in our institution. Seroma is common. This study aimed to compare the quilting suture and conventional closure in prevention of seroma after total mastectomy and axillary dissection.
METHODS
This randomized comparative study was carried out from January 2018 to June 2019 in Yangon General Hospital. One hundred and forty patients (70 conventional and 70 quilting) were included. For quilting group, customized strategically placed interrupted alternate sutures were placed 2-3 cm apart with 3/0 vicryl sutures between skin flap and pectoral muscle.
RESULTS
Age, body mass index and tumour diameter were comparable between the groups. The mean duration of operation was 111.44 ± 7.045 min in conventional and 124.5 ± 6.39 min in quilting (P = 0.0001). The mean drain output for conventional group was not significantly different from quilting group. In quilting, some area developed dimpling which resolved within a week. A total of 21 (30%) patients in the conventional group and 10 patients (14.3%) in the quilting group developed seroma (P = 0.041). The mean frequency and amount of seroma aspiration were significantly lower in the quilting group. Shoulder movement limitation and analgesia use showed no significant difference.
CONCLUSION
Although total amount of drain output, duration of drain, hospital stay and post-operative complications were not different, the incidence of seroma was significantly lower in quilting group. Seroma is treated with more ease in the quilting group as the frequency and amount of aspiration were lower and less frequent follow-up visits were required. Quilting can reduce the seroma incidence in total mastectomy and axillary dissection for breast cancer patients.",2020,"Shoulder movement limitation and analgesia use showed no significant difference.
","['breast cancer patients', 'One hundred and forty patients (70 conventional and 70 quilting) were included', 'breast cancer patients in our institution', 'January 2018 to June 2019 in Yangon General Hospital']","['customized strategically placed interrupted alternate sutures were placed 2-3 cm apart with 3/0 vicryl sutures between skin flap and pectoral muscle', 'Total mastectomy and axillary dissection', 'quilting suture and conventional closure', 'Quilting suture versus conventional closure']","['incidence of seroma', 'mean duration of operation', 'mean frequency and amount of seroma aspiration', 'seroma', 'total amount of drain output, duration of drain, hospital stay and post-operative complications', 'mean drain output', 'seroma incidence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4044304', 'cui_str': 'Quilt'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1576039', 'cui_str': 'Vicryl suture'}, {'cui': 'C1562051', 'cui_str': 'Skin flap'}, {'cui': 'C0030747', 'cui_str': 'Pectoral muscle structure'}, {'cui': 'C2960728', 'cui_str': 'Total mastectomy and axillary dissection'}, {'cui': 'C4044304', 'cui_str': 'Quilt'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0290088,"Shoulder movement limitation and analgesia use showed no significant difference.
","[{'ForeName': 'Sie Thu', 'Initials': 'ST', 'LastName': 'Myint', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Khin San', 'Initials': 'KS', 'LastName': 'Khaing', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Yee', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Soe Myat', 'Initials': 'SM', 'LastName': 'Mon', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}, {'ForeName': 'Thein', 'Initials': 'T', 'LastName': 'Lwin', 'Affiliation': 'Department of Surgery, University of Medicine (1), Yangon, Myanmar.'}]",ANZ journal of surgery,['10.1111/ans.16091']
1012,32568433,Alterations in Functional Connectivity During Different Phases of the Triggered Migraine Attack.,"OBJECTIVE
To understand the changes in functional connectivity between brain areas of potential importance in migraine during different phases of the attack.
BACKGROUND
Migraine is a symptomatically heterogeneous disorder. Understanding the possible changes in brain function and, therefore, neurobiology during different phases of the migraine attack is important in developing disease biomarkers and advancing therapeutics.
DESIGN
Randomized, double-blind, placebo-controlled, multi-visit experimental study.
METHODS
Subjects aged 18-50 years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n = 53). Consented subjects were randomized to a 0.5 µg/kg/min nitroglycerin infusion or to placebo over 20 minutes across different study visits, during the period February 2015-July 2017.* All subjects were exposed to a nitroglycerin infusion at least on 1 occasion at screening.** For those subjects who consented to participate in imaging visits (n = 25), structural T1, T2 and FLAIR sequences and resting state blood oxygen level dependant contrast (rsBOLD) time series, using a multiecho EPI sequence, were conducted over 30-40 minutes at baseline and rsBOLD during premonitory symptoms and migraine headache on a 3T General Electric MR750 MRI scanner. For the placebo visit, the imaging was conducted at the same times following infusion in the absence of symptoms.
RESULTS
Montreal Neurological Institute (MNI) coordinates were used to characterize identified brain areas of connectivity change. Using repeated measures ANOVA models with time (visit number) and trigger substance (nitroglycerin/placebo) as factors, significant positive functional coupling was found between the thalami bilaterally and the right precuneus and cuneus regions during the nitroglycerin-triggered premonitory phase (T = 3.23, peak connectivity change at [-6, -68, 40] for left thalamus, P = 0.012 and [-4, -68, 40] for right thalamus, P = 0.019). The nitroglycerin-triggered premonitory phase was associated with a change in the direction of connectivity from positive to negative between the pons and the limbic lobe (T = 3.47, peak connectivity change at [2, 8, 50], P < 0.001). The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = 0.007).
CONCLUSIONS
Understanding the functional reorganization between subcortical and cortical brain areas in different phases of the migraine attack provides novel insights into the abnormal sensory processing and integration during migraine, as well as functional correlation with clinical symptoms displayed during each phase. [*Correction added on July 22, 2020 after first online publication: This sentence was revised from, ""Consented subjects had a 0.5 μg/kg/min nitroglycerin infusion…"".] [**Correction added on July 22, 2020 after first online publication: This sentence was revised from, ""… at least on 1 occasion at screening.""].",2020,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007).
","['Montreal Neurological Institute (MNI', 'Subjects aged 18-50\xa0years with migraine with and without aura (≤22 headache days per month) were recruited from across the UK using advertising, from both population and hospital clinic samples (n\xa0=\xa053']","['substance (nitroglycerin/placebo', 'nitroglycerin infusion or to placebo', 'nitroglycerin', 'placebo']","['Functional Connectivity', 'positive functional coupling', 'structural T1, T2 and FLAIR sequences and resting state blood oxygen level']","[{'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0001690', 'cui_str': 'Advertising as Topic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.063712,"The headache phase of the nitroglycerin-triggered migraine attack was associated with ongoing negative functional coupling between the pons and the cingulate and frontal cortices, and positive functional coupling between the pons and the cerebellar tonsils and medulla (T = 3.47, peak connectivity change at [-8, -52, -58], P = .007).
","[{'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Karsan', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Pyari R', 'Initials': 'PR', 'LastName': 'Bose', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': ""O'Daly"", 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Fernando O', 'Initials': 'FO', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Centre for Neuroimaging Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""Headache Group, Department of Basic and Clinical Neuroscience, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Headache,['10.1111/head.13865']
1013,32564940,How to improve adherence the captors of phosphorus on hemodialysis: Experience in real life with sucroferric oxyhydroxide.,"INTRODUCTION
The lack of adherence to phosphate -binders (PB) is the most important factor in not achieving the objectives of serum phosphorus (sP). Studies in the real-world population are needed to understand the influence of PBs on adherence and how to modify it.
METHODS
Prospective study conducted during 3 months in usual clinical practice. Out of 105 hemodialysis patients, 57 were switched to SFOH and 48 maintained their baseline treatment (control group). sP levels and the percentage of patients with sP levels <5mg/dl were compared. Adherence before and after introduction of SFOH, number of pills of PB, preferences in the administration mode and side effects were analyzed.
RESULTS
The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS). The average of daily tablets decreased significantly in the SFOH group (7.2-2.3 comp, p<0.001), but not in the control group (5.6-5.6, p=NS) and 100% of the patients used only one PB in SFOH group. The use of SFOH increased the adherence according to the SMAQ questionnaire (57.8-84.3%; OR 13.1, p<0.001). The possibility to choose the preferred mode of administration (split-swallowing 89% compared to chewing 11%), improved the acceptance (44.7-78%). 14% of the patients experienced side effects and in 5.2% SFOH was discontinued for this reason.
CONCLUSIONS
SFOH controlled serum sP in 93% of patients, 100% in monotherapy, and with fewer tablets. The exploration and adaptation of preferences in the mode of administration influenced the acceptance of the drug by the patient and, probably, the future adherence.",2020,"The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS).","['Prospective study conducted during 3 months in usual clinical practice', '105 hemodialysis patients, 57 were switched to SFOH and 48 maintained their baseline treatment (control group']","['sucroferric oxyhydroxide', 'SFOH']","['sP levels', 'side effects', 'average of daily tablets', 'acceptance']","[{'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3696416', 'cui_str': 'sucroferric oxyhydroxide'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",105.0,0.0183717,"The percentage of patients with controlled sP (<5mg/dl) increased significantly in the SFOH users' group (62.1-92.9%, p<0.001), but not in the control group (83-83.3%, p=NS).","[{'ForeName': 'M Dolores', 'Initials': 'MD', 'LastName': 'Arenas Jiménez', 'Affiliation': 'Nephrology Department, Hospital Vithas Perpetuo Internacional, Alicante, Spain; Nephrolgy Department, Hospital del Mar, Barcelona, Spain. Electronic address: lola@olemiswebs.com.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Navarro González', 'Affiliation': 'Nephrology Department, Hospital Universitario Nuestra Señora de la Candelaria, RedinRen, Santa Cruz de Tenerife, Spain.'}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2020.04.011']
1014,32568172,Mobilisation efficacy in young patients with different stages of degenerative disc disease.,"BACKGROUND
Lumbar vertebrae carry the greatest load from the spinal column, often leading to several pathologies, including degenerative disc disease (DDD), potentially disturbing spinal movement patterns. Mobilisation increases hypomobile segment mobility, however there is little evidence on mobilisation in patients suffering from different types of DDD.
OBJECTIVE
To assess the efficacy of mobilisation in young patients with DDD, as diagnosed by MRI.
METHODS
Thirty patients (24-35 years) participated in this study, and were divided into two groups, based on progression levels of DDD diagnosed by MRI (protrusion-PRO/extrusion-EXT). Twenty sessions of sustained stretch mobilisation (grade III) were applied to both groups over four weeks. Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), straight leg raise (SLR), passive lumbar extension (PLE) and lumbar range of motion (ROM) assessed outcome variables. Three trial stages were investigated: pre-therapy (1), post-therapy (2) and follow-up (3).
RESULTS
Age (p= 0.007) and NRS (p= 0.002) were significantly different before therapy. Patient outcomes were significantly improved for all parameters in both groups, except SLR which improved in the EXT group only (p= 0.043).
CONCLUSIONS
Applied treatments improved patient outcomes and were statistically significant in both groups, however, better outcomes were observed in the EXT group during follow-up. Mobilisation was a safe and effective procedure for the treatment of DDD.",2020,"Patient outcomes were significantly improved for all parameters in both groups, except SLR which improved in the EXT group only (p= 0.043).
","['young patients with different stages of degenerative disc disease', 'young patients with DDD, as diagnosed by MRI', 'patients suffering with different types of DDD', 'Thirty patients (24-35 years']",['EXT'],"['Numeric rating scale (NRS), Oswestry disability index (ODI), straight leg raise (SLR), passive lumbar extension (PLE) and lumbar range of motion (ROM', 'Mobilisation efficacy']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015306', 'cui_str': 'Multiple congenital exostosis'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0152992,"Patient outcomes were significantly improved for all parameters in both groups, except SLR which improved in the EXT group only (p= 0.043).
","[{'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kuligowski', 'Affiliation': ''}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Dȩbiec-Ba K', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Skrzek', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181219']
1015,32562433,Effects of illness representation-focused patient education on illness representations and self-care in patients with heart failure: A randomised clinical trial.,"AIMS AND OBJECTIVES
To examine the effect of an illness representation-focused patient education intervention on illness representations and self-care behaviours in patients with heart failure 3 months after discharge from the hospital.
BACKGROUND
Few intervention studies have examined the effect of illness representation-focused interventions on illness representations and self-care in patients with heart failure.
DESIGN
A randomised clinical trial based on the Consolidated Standard of Reporting Trials-CONSORT 2010-guidelines was employed. The Clinical Trial Registry number is TCTR20190903002.
METHODS
One hundred and seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the usual care group) completed the baseline and one- and three-month postdischarge follow-up assessments. The instruments included the Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index. The intervention group received illness representation-focused patient education while hospitalised and telephone follow-ups after discharge. Data were analysed with linear mixed-effects model analysis.
RESULTS
The 107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03%. At baseline, the two groups tended to have accurate illness beliefs but insufficient self-care confidence and self-care maintenance. The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
CONCLUSION
The study did not show an effect of the intervention on illness representations or self-care maintenance behaviours. However, the intervention did maintain participants' self-care confidence three months after discharge.
RELEVANCE TO CLINICAL PRACTICE
It is necessary to conduct long-term follow-ups of patients' illness representations, discuss the implementation of self-care behaviours with patients, enhance patients' self-care confidence, and involve family members or caregivers in self-care practices when needed.",2020,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","['patients with heart failure three months after discharge from the hospital', '107 participants had a mean age of 62.17 years and a mean left ventricular ejection of 53.03', 'One hundred seven participants were randomly assigned to 2 groups, and 62 participants (n = 30 in the intervention group and n = 32 in the', 'Patients with Heart Failure', 'patients with heart failure']","['illness representation-focused patient education intervention', 'Illness Representation-Focused Patient Education', 'illness representation-focused patient education while hospitalized and telephone follow-ups after discharge', 'usual care group) completed the baseline and one- and three-month post-discharge follow-up assessments']","['illness representations or self-care maintenance behaviours', 'illness representations and self-care behaviours', 'illness representation total scores, dimension scores or self-care maintenance scores', 'Survey of Illness Beliefs in Heart Failure and the Self-care of Heart Failure Index', 'Illness Representations and Self-care', 'self-care confidence scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2733342', 'cui_str': 'Left ventricular ejection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C1320368', 'cui_str': 'Post-discharge follow-up'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",107.0,0.121429,"The analysis showed no significant differences between groups in the illness representation total scores, dimension scores or self-care maintenance scores but did show a significant difference in the self-care confidence scores (F = 3.42, p < .05) over the three months.
","[{'ForeName': 'Wan-Tzu', 'Initials': 'WT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Shan-Tair', 'Initials': 'ST', 'LastName': 'Wang', 'Affiliation': 'Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi City, Taiwan.'}, {'ForeName': 'Chih-Hsin', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Liang-Miin', 'Initials': 'LM', 'LastName': 'Tsai', 'Affiliation': 'Department of Internal Medicine, Tainan Municipal Hospital, Tainan, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Chan', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hsing-Mei', 'Initials': 'HM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15384']
1016,32562498,Utilizing registry data to identify children with cerebral palsy previously enrolled in the magnesium sulfate randomized clinical trial.,,2020,,['children with cerebral palsy previously enrolled in the'],['magnesium sulfate'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]",[],,0.0847808,,"[{'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Adams-Chapman', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, USA.""}]",Developmental medicine and child neurology,['10.1111/dmcn.14600']
1017,32568092,An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial.,"BACKGROUND
Although the most effective methods of contraception are available in Bolivia, unmet need for contraception among women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016). Mobile phones are a popular mode to deliver health behavior support. We developed a contraceptive behavioral intervention for young Bolivian women delivered by mobile phone and guided by behavioral science. The intervention consists of short instant messages sent through an app over 4 months.
OBJECTIVE
This trial aimed to evaluate the effect of the intervention on young Bolivian women's use of and attitudes toward the effective contraceptive methods available in Bolivia.
METHODS
This was a parallel group, individually randomized superiority trial with a 1:1 allocation ratio. Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish. The target sample size was 1310 participants. Participants allocated to the intervention had access to an app with standard family planning information and intervention messages. Participants allocated to the control group had access to the same app and control messages. Coprimary outcomes were use of effective contraception and acceptability of at least one method of effective contraception at 4 months. Secondary outcomes were use of effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion. Process outcomes included knowledge, perceived norms, personal agency, and intention. Outcomes were analyzed using logistic and linear regression. We also asked participants about physical violence.
RESULTS
A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception. There was no evidence that use differed between the groups (33% control vs 37% intervention; adjusted odds ratio [OR] 1.19, 95% CI 0.80 to 1.77; P=.40). There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06). There were no statistically significant differences in any of the secondary or process outcomes. The intervention dose received was low. In the control group, 2.8% (6/207) reported experiencing physical violence compared with 1.9% (4/202) in the intervention group (Fisher exact test P=.75).
CONCLUSIONS
This trial was unable to provide definitive conclusions regarding the effect of the intervention on use and acceptability of effective contraception because of under recruitment. Although we cannot strongly recommend implementation, the results suggest that it would be safe and may increase the acceptability of effective contraception if the intervention messages were offered alongside the download of the app.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02905526; https://clinicaltrials.gov/ct2/show/NCT02905526.",2020,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","['1310 participants', 'women aged 15 to 19 years is estimated to be 38% (2008), and the adolescent fertility rate is 71 per 1000 women (2016', 'A total of 640 participants were enrolled, and 67.0% (429) of them contributed follow-up data for the coprimary outcome, the use of effective contraception', 'Women were eligible if they were aged 16 to 24 years, owned a personal Android mobile phone, lived in La Paz or El Alto, reported an unmet need for contraception, and could read Spanish', 'Young Women in Bolivia', ""young Bolivian women's"", 'young Bolivian women delivered by', 'participants about physical violence']","['intervention had access to an app with standard family planning information and intervention messages', 'control group had access to the same app and control messages', 'Mobile Phone Instant Messaging', 'mobile phone and guided by behavioral science', 'contraceptive behavioral intervention']","['acceptability', 'experiencing physical violence', 'acceptability of effective contraception', 'effective contraception and acceptability of at least one method of effective contraception', 'knowledge, perceived norms, personal agency, and intention', 'effective contraception during the study, acceptability of the individual methods, service uptake, unintended pregnancy, and abortion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1277145', 'cui_str': 'Reads Spanish'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005918', 'cui_str': 'Bolivia'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0004940', 'cui_str': 'Behavioral Sciences'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",640.0,0.278254,"There was a borderline significant effect regarding acceptability (63% control vs 72% intervention; adjusted OR 1.49, 95% CI 0.98 to 2.28; P=.06).","[{'ForeName': 'Ona L', 'Initials': 'OL', 'LastName': 'McCarthy', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Aliaga', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Torrico Palacios', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Jhonny', 'Initials': 'J', 'LastName': 'López Gallardo', 'Affiliation': 'CIES Salud Sexual Salud Reproductiva, La Paz, Bolivia.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Huaynoca', 'Affiliation': 'International Planned Parenthood Federation/Western Hemisphere Region, New York, NY, United States.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Leurent', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Edwards', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Palmer', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Irrfan', 'Initials': 'I', 'LastName': 'Ahamed', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Free', 'Affiliation': 'The London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of medical Internet research,['10.2196/14073']
1018,32569567,"Are basic robotic surgical skills transferable from the simulator to the operating room? A randomized, prospective, educational study.","INTRODUCTION
We aimed to assess the transferability of basic robotic skills from the simulator to the operating room (OR) while performing robotic-assisted radical prostatectomy (RARP).
METHODS
Fourteen urology residents were randomized into two groups: group A was required to practice three sessions (nine tasks each) on the simulator, whereas group B was required to practice (same nine tasks) until they reached competency. Both groups were recorded while practicing on the da Vinci Surgical Skills Simulator. Both groups were then recorded while performing bladder mobilization during RARP. Senior residents from both groups were also recorded while performing urethro-vesical anastomosis during RARP. Recordings were assessed blindly using the validated Global Evaluative Assessment of Robotic Skills (GEARS) tool by C-SATS. Spearman's correlation coefficient (rho) was used to assess correlation between GEARS scores from practice sessions on the da Vinci Simulator and the GEARS scores from bladder mobilization and urethro-vesical anastomosis during RARP.
RESULTS
There was no difference in total GEARS scores between the two groups in the OR. Total GEARS scores for ""ring and rail 2"" and ""suture sponge"" tasks correlated with the total GEARS scores during urethro-vesical anastomosis (rho=0.86, p=0.007; rho=0.90, p=0.002, respectively). GEARS' efficiency component during ""energy and dissection"" task on the da Vinci Simulator correlated with GEARS' efficiency component during bladder mobilization (rho=0.62, p=0.03). GEARS' force sensitivity component during ""ring and rail 2"" and ""dots and needles"" tasks on the da Vinci Simulator correlated with GEARS' force sensitivity component during bladder mobilization (rho=0.58, p=0.047; rho =0.65, p=0.02, respectively).
CONCLUSIONS
Objective assessments of urology residents on the da Vinci Surgical Skills Simulator tasks ring and rail 2 and suture sponge correlated with their objective assessments of bladder mobilization and urethro-vesical anastomosis. Therefore, basic robotic skills could be transferred from the simulator to the OR.",2020,"Total GEARS scores for ""ring and rail 2"" and ""suture sponge"" tasks correlated with the total GEARS scores during urethro-vesical anastomosis (rho=0.86, p=0.007; rho=0.90, p=0.002, respectively).",['Fourteen urology residents'],['robotic-assisted radical prostatectomy (RARP) prostatectomy'],"['Total GEARS scores', 'total GEARS scores']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0262218,"Total GEARS scores for ""ring and rail 2"" and ""suture sponge"" tasks correlated with the total GEARS scores during urethro-vesical anastomosis (rho=0.86, p=0.007; rho=0.90, p=0.002, respectively).","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Almarzouq', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Yasser A', 'Initials': 'YA', 'LastName': 'Noureldin', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Yin', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Anidjar', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Bladou', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tanguay', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Wassim', 'Initials': 'W', 'LastName': 'Kassouf', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Armen G', 'Initials': 'AG', 'LastName': 'Aprikian', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Sero', 'Initials': 'S', 'LastName': 'Andonian', 'Affiliation': 'Division of Urology, McGill University Health Centre, Montreal, QC, Canada.'}]",Canadian Urological Association journal = Journal de l'Association des urologues du Canada,['10.5489/cuaj.6460']
1019,32578261,Social story-based oral health promotion for preschool children with special healthcare needs: A 24-month randomized controlled trial.,"OBJECTIVES
This study aimed to investigate the efficacy of the social story-based intervention in promoting the oral health status among preschool children with special healthcare needs.
METHODS
The 24-month randomized controlled trial recruited 306 children from centres that provided educational training for 2- to 6-year-old children who had special healthcare needs. The participants received standardized toothbrushing training and oral health education materials. The education materials for children in the test group were validated social stories, while materials for children in the control group were standard leaflets. Those materials were introduced in each training session and used at home by parents. Children's oral health status and oral health-related behaviours were assessed before and after interventions. Data were analysed via generalized estimating equations, negative binomial regression and binary logistic regression.
RESULTS
There was no significant difference in caries experience among children in both groups after 24 months. However, children in the test group showed better oral hygiene status and better toothbrushing performance, and they were more likely to visit a dentist (OR = 2.00, 95% CI:1.15,3.49) than their peers in the control group. Caries progression was more likely to be observed among children who had low social skills or whose parents were not working full-time. Children from high-income families showed better oral hygiene status than their peers (Estimate = -0.11, 95%CI: -0.20,-0.01).
CONCLUSION
Social stories could be used to improve oral health-related behaviours among young children with SHCN. The efficacy of the intervention might be associated with children's adaptive skills and family socio-demographic status.",2020,"Children from high-income families showed better oral hygiene status than their peers (Estimate = -0.11, 95%CI: -0.20,-0.01).
","['306 children from centres that provided educational training for 2- to 6-year-old children who had special healthcare needs', 'preschool children with special healthcare needs', 'young children with SHCN']","['social story-based intervention', 'standardized toothbrushing training and oral health education materials', 'Social story-based oral health promotion']","['caries experience', 'oral health-related behaviours', 'Caries progression', ""Children's oral health status and oral health-related behaviours"", 'oral hygiene status', 'oral hygiene status and better toothbrushing performance', 'validated social stories']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0150290', 'cui_str': 'Oral health promotion'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C4082459', 'cui_str': 'Oral hygiene status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}]",306.0,0.0527307,"Children from high-income families showed better oral hygiene status than their peers (Estimate = -0.11, 95%CI: -0.20,-0.01).
","[{'ForeName': 'Ni', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Paediatric Dentistry & Orthodontics, Faculty of Dentistry, 2/F Prince Philip Dental Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Hai Ming', 'Initials': 'HM', 'LastName': 'Wong', 'Affiliation': 'Paediatric Dentistry & Orthodontics, Faculty of Dentistry, 2/F Prince Philip Dental Hospital, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Periodontology and Public Health, Faculty of Dentistry, 2/F Prince Philip Dental Hospital, The University of Hong Kong, Hong Kong SAR, China.'}]",Community dentistry and oral epidemiology,['10.1111/cdoe.12554']
1020,32683489,A brief bout of exercise in hypoxia reduces ventricular filling rate and stroke volume response during muscle metaboreflex activation.,"PURPOSE
The hemodynamic consequences of exercise in hypoxia have not been completely investigated. The present investigation aimed at studying the hemodynamic effects of contemporary normobaric hypoxia and metaboreflex activation.
METHODS
Eleven physically active, healthy males (age 32.7 ± 7.2 years) completed a cardiopulmonary test on an electromagnetically braked cycle-ergometer to determine their maximum workload (W max ). On separate days, participants performed two randomly assigned exercise sessions (3 minutes pedalling at 30% of W max ): (1) one in normoxia (NORMO), and (2) one in normobaric hypoxia with FiO 2 set to 13.5% (HYPO). After each session, the following protocol was randomly assigned: either (1) post-exercise muscle ischemia (PEMI) to study the metaboreflex, or (2) a control exercise recovery session, i.e., without metaboreflex activation. Hemodynamics were assessed with impedance cardiography.
RESULTS
The main result was that the HYPO session impaired the ventricular filling rate (measured as stroke volume/diastolic time) response during PEMI versus control condition in comparison to the NORMO test (31.33 ± 68.03 vs. 81.52 ± 49.23 ml·s -1 ,respectively, p = 0.003). This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020). As a consequence, cardiac output response was impaired during the HYPO test.
CONCLUSIONS
The present investigation suggests that a brief exercise bout in hypoxia is capable of impairing cardiac filling rate as well as stroke volume during the metaboreflex. These results are in good accordance with recent findings showing that among hemodynamic modulators, ventricular filling is the most sensible variable to hypoxic stimuli.",2020,"This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020).","['Eleven physically active, healthy males (age 32.7\u2009±\u20097.2\xa0years) completed a']","['post-exercise muscle ischemia (PEMI) to study the metaboreflex, or (2) a control exercise recovery session, i.e., without metaboreflex activation', 'cardiopulmonary test on an electromagnetically braked cycle-ergometer to determine their maximum workload (W max ', 'exercise sessions (3 minutes pedalling at 30% of W max ): (1) one in normoxia (NORMO), and (2) one in normobaric hypoxia with FiO 2 set to 13.5% (HYPO']","['stroke volume/diastolic time) response', 'cardiac output response', 'ventricular filling rate', 'stroke volume response']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4517559', 'cui_str': '13.5'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]",11.0,0.067047,"This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Mulliri', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Magnani', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Roberto', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Sechi', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Ghiani', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Sainas', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Nughedu', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Hosseini Kakhak', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Hakim Sabzevari University, Sabzevar, Iran.'}, {'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Bassareo', 'Affiliation': 'University College of Dublin, Mater Misericordiae University Teaching Hospital, Dublin, Ireland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Crisafulli', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy. crisafulli@tiscali.it.'}]",European journal of applied physiology,['10.1007/s00421-020-04435-0']
1021,32573767,Information on early medical abortion for women using an audiovisual animation vs face-to-face consultation: A consortium randomized and quasi-randomized trial.,"INTRODUCTION
There is some evidence that audiovisual formats can be an effective way of providing information about early medical abortion (EMA). A short animation (3 minutes) was developed about EMA in three languages that summarized the EMA process for use in the UK, France and Sweden.
MATERIAL AND METHODS
We conducted a multicenter randomized controlled trial to compare information on EMA delivered by an animated film vs a face-to-face consultation. Women requesting EMA (≤9 weeks' gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited. The primary outcome was women's recall of prespecified key information on EMA. Secondary outcomes were acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale. The study was prospectively registered with clinicaltrials.gov, ID number: NCT03417362.
RESULTS
172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48). There was no statistically significant difference in recall scores between the animation and standard arms in Edinburgh and Stockholm sites. However, the difference between arms at the Paris site was statistically significant (P = .007) in favor of the animation. All participants in the animation arm rated it as an acceptable way to receive information on EMA.
CONCLUSIONS
A ""short"" audiovisual animation can adequately and acceptably deliver key information about EMA. This intervention could be used routinely to provide standardized and high-quality information to women seeking EMA.",2020,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","['Women requesting EMA (<=9 weeks gestation) from abortion clinics in Edinburgh (UK), Paris (France) and Stockholm (Sweden) were recruited', '172 women completed the study (Edinburgh = 50, Paris = 78, Stockholm = 48']",['audiovisual animation'],"['recall scores', ""women's recall of prespecified key information on EMA"", 'acceptability of mode of information delivery, clarity and helpfulness of information rated on a Likert scale']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000789', 'cui_str': 'Abortion Clinics'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376650', 'cui_str': 'Animation'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3146282', 'cui_str': 'Medical termination of pregnancy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",172.0,0.142109,"However, the difference between arms at the Paris site was statistically significant (P=0.007) in favour of the animation.","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Reynolds-Wright', 'Affiliation': 'MRC Center for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Belleuvre', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Daberius', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Faucher', 'Affiliation': 'Public Assistance Hospitals of Paris (APHP), Paris, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'MRC Center for Reproductive Healthcare, University of Edinburgh, Edinburgh, UK.'}]",Acta obstetricia et gynecologica Scandinavica,['10.1111/aogs.13944']
1022,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND
Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated.
MATERIALS AND METHODS
We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C.
RESULTS
A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant).
CONCLUSIONS
There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012']
1023,32579078,Observations on changes in ventricular repolarization following four weeks of exercise training in chronic heart failure patients.,"OBJECTIVE
The aim of this study was to investigate the effects of exercise training on ventricular repolarization dynamicity and heart rate variability in chronic heart failure patients.
DESIGN
A total of 22 chronic heart failure patients with reduced ejection fraction in sinus rhythm were included in the study. The patients were in NYHA classes II-III with an ejection fraction of 29.7 ± 7.7%. Before and after 4 weeks of aerobic exercise training, all patients performed a cardiopulmonary exercise test, a standard twelve-lead electrocardiogram and a 24 h Holter recording from which heart rate variability and ventricular repolarization dynamicity were assessed.
RESULTS
We observed a significant decrease of QTpeak ( p < .001) and QTend ( p < .001) at RR intervals ranging from 600 to 1000 ms on 24 h QT/RR regressions after 4 weeks of exercise training. Our analyses revealed that short-term exercise training induced significant changes in the frequency and time domain HRV parameters on an overall time-period of 24 h.
CONCLUSION
Four weeks of exercise training induced significant changes in ventricular repolarization dynamicity in chronic heart failure patients. In addition, short-term exercise training was enough to improve patients' heart rate variability.",2020,We observed a significant decrease of QTpeak ( p < .001) and QTend ( p < .001) at RR intervals ranging from 600 to 1000 ms on 24 h QT/RR regressions after 4 weeks of exercise training.,"['chronic heart failure patients', '22 chronic heart failure patients with reduced ejection fraction in sinus rhythm']","['exercise training', 'short-term exercise training', 'aerobic exercise training']","['ventricular repolarization', 'ventricular repolarization dynamicity and heart rate variability', 'frequency and time domain HRV parameters', 'ventricular repolarization dynamicity', 'QTpeak']","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",22.0,0.0155513,We observed a significant decrease of QTpeak ( p < .001) and QTend ( p < .001) at RR intervals ranging from 600 to 1000 ms on 24 h QT/RR regressions after 4 weeks of exercise training.,"[{'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Caru', 'Affiliation': 'Laboratory of Pathophysiology of EXercise (LPEX), School of Kinesiology and Physical Activity Sciences, Faculty of Medicine, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gravel', 'Affiliation': 'Laboratory of Pathophysiology of EXercise (LPEX), School of Kinesiology and Physical Activity Sciences, Faculty of Medicine, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'INSERM U586, Laboratory of Medical and Clinical Pharmacology, Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bousquet', 'Affiliation': 'Clinic of Saint-Orens, Cardiovascular and Pulmonary Rehabilitation Center, Saint-Orens, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Galinier', 'Affiliation': 'INSERM U586, Laboratory of Medical and Clinical Pharmacology, Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Jacquemet', 'Affiliation': 'Department of Pharmacology and Physiology, University of Montreal, Montreal, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Curnier', 'Affiliation': 'Laboratory of Pathophysiology of EXercise (LPEX), School of Kinesiology and Physical Activity Sciences, Faculty of Medicine, University of Montreal, Montreal, Canada.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2020.1783458']
1024,32573795,Evaluation of the Pharmacokinetic Interaction of Ubrogepant Coadministered With Sumatriptan and of the Safety of Ubrogepant With Triptans.,"OBJECTIVE
To evaluate the potential for pharmacokinetic interaction and the safety and tolerability when ubrogepant and sumatriptan are coadministered in a Phase 1 study in healthy participants, and to inform the safety and tolerability of ubrogepant alone and in combination with triptans in Phase 3 trials in participants with migraine.
BACKGROUND
Calcitonin gene-related peptide is a potent vasodilatory neurotransmitter believed to play a key role in the pathophysiology of migraine. Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine. Sumatriptan is a serotonin receptor agonist and the most commonly used triptan for the acute treatment of migraine. Ubrogepant could be prescribed with triptans.
DESIGN
The Phase 1 study was a single-center, open-label, randomized, 3-way crossover, single-dose, pharmacokinetic interaction study, where participants received each of 3 oral treatments with a 7-day washout period between treatments: single dose of ubrogepant 100 mg, single dose of sumatriptan 100 mg, and ubrogepant 100 mg plus sumatriptan 100 mg. Pharmacokinetic parameters were calculated using a model-independent approach. The ACHIEVE I and II trials were 2 multicenter, single-attack, randomized, Phase 3 trials in adults with a history of migraine with or without aura. Participants had the option to take a second dose of study medication or rescue medication to treat a nonresponding migraine or a migraine recurrence from 2 to 48 hours after the initial dose of study medication. Rescue medication options included acetaminophen, nonsteroidal anti-inflammatory drugs, opioids, anti-emetics, or triptans. Treatment-emergent adverse events were evaluated up to 30 days after the last dose in the Phase 1 and Phase 3 studies.
RESULTS
Ubrogepant median time to maximum plasma concentration was delayed (3 hours [range: 1-5 hours] vs 1.5 hours [range: 1-4 hours]), mean maximum plasma concentration was reduced by 24% (coefficient of variation: 37.4%) when ubrogepant was coadministered with sumatriptan (n = 29) compared with ubrogepant administered alone (N = 30). No significant effect was observed on the area under the plasma concentration-time curve of ubrogepant. Sumatriptan area under the curve and maximum plasma concentration showed no significant change when sumatriptan was coadministered with ubrogepant (n = 29), but the sumatriptan time to maximum plasma concentration was delayed (1 hour [range: 0.5-5 hours] vs 3 hours [range: 0.5-6 hours]. No treatment-emergent adverse events were reported with the coadministration of ubrogepant 100 mg and sumatriptan 100 mg in the Phase 1 study. The pooled safety data from ACHIEVE trials (N = 1938) showed similar rates of treatment-related treatment-emergent adverse events between participants who took ubrogepant alone and participants who took ubrogepant and a triptan as a rescue medication (14.9% [53/355] vs 12.8% [5/39] in the ubrogepant 100 mg treatment group, respectively).
CONCLUSIONS
Although there were slight alterations in ubrogepant pharmacokinetic parameters when coadministered with sumatriptan, such changes are expected to have minimal clinical relevance, especially because no changes were seen in sumatriptan area under the curve and maximum plasma concentration when coadministered with ubrogepant. Coadministration of ubrogepant with sumatriptan was well tolerated in healthy participants in the Phase 1 study, and coadministration of ubrogepant with triptans was well tolerated in participants with migraine in the Phase 3 trials. No new safety concerns for ubrogepant were identified across all trials.",2020,Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine.,"['Participants had the option to take a second dose of study medication or rescue medication to treat a nonresponding migraine or a migraine recurrence from 2 to 48\xa0hours after the initial dose of study medication', 'participants with migraine', 'adults with a history of migraine with or without aura', 'participants with migraine in the Phase 3 trials', 'healthy participants']","['Ubrogepant Coadministered With Sumatriptan', 'ubrogepant 100\xa0mg, single dose of sumatriptan 100\xa0mg, and ubrogepant 100\xa0mg plus sumatriptan 100\xa0mg', 'sumatriptan', 'Sumatriptan']","['Sumatriptan area under the curve and maximum plasma concentration', 'mean maximum plasma concentration', 'acetaminophen, nonsteroidal anti-inflammatory drugs, opioids, anti-emetics, or triptans', 'Ubrogepant median time to maximum plasma concentration', 'sumatriptan time to maximum plasma concentration', 'rates of treatment-related treatment-emergent adverse events', 'safety and tolerability', 'area under the plasma concentration-time curve of ubrogepant', 'Pharmacokinetic parameters']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0236018', 'cui_str': 'Aura'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1126059', 'cui_str': 'Sumatriptan 100 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0075632', 'cui_str': 'Sumatriptan'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0162754', 'cui_str': 'Serotonin 5-HT1 receptor agonist'}, {'cui': 'C4505936', 'cui_str': 'ubrogepant'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0313899,Ubrogepant (UBRELVY™) is a potent and selective antagonist of the human calcitonin gene-related peptide receptor approved for the acute treatment of migraine.,"[{'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Jakate', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Boinpally', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Butler', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McGeeney', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Periclou', 'Affiliation': 'Allergan plc, Madison, NJ, USA.'}]",Headache,['10.1111/head.13862']
1025,32578404,Modification of Affective Trajectory in a Positive Psychology Intervention.,"Enhancing positive affect (PA) and reducing negative affect (NA) are targets of positive psychology interventions, and well-being and positive functioning are core elements of mental health. However, the underlying temporal dynamics of these elements are unknown. This study aimed at identifying how a 42-day daily positive psychology intervention (PPI) impacts affective longitudinal dynamics compared to a control condition. This study employed an experience sampling method (self-observation diary including the Measurement of Affectivity: Valence/Activation scale, MAVA) with two non-randomised groups-a control group (n = 43) and an intervention group (n = 43)-taken from a community sample. Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI. The deactivated PA trajectory increased non-linearly across the PPI, whereas the activated PA trajectory showed a linear increase. This study suggests that PPIs change daily affective life.",2020,"Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI.",[],"['42-day daily positive psychology intervention (PPI', 'intervention group (n\xa0']","['deactivated PA trajectory', 'PPIs change daily affective life']",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",43.0,0.0211071,"Compared to the control participants, the PPI participants' trajectories for activated and deactivated NA showed an important decrease over the course of the PPI.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Congard', 'Affiliation': 'Nantes University, Laboratoire de Psychologie des Pays de la Loire, LPPL, EA 4638, Nantes, France.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andreotti', 'Affiliation': 'University of Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Lille, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Dauvier', 'Affiliation': 'Center for Research on the Psychology of Cognition, Langage and Emotion, Aix-Marseille University, Aix-en-Provence, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Le Vigouroux', 'Affiliation': 'University of Nimes, EA 7352, CHROME, Nîmes Cedex 01, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': 'University of Lille, CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Lille, France.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12206']
1026,32565008,Measuring Apathy in Alzheimer's Disease in the Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): A Comparison of Instruments.,"BACKGROUND
Diagnostic criteria for apathy have been published but have yet to be evaluated in the context of clinical trials. The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2) operationalized the diagnostic criteria for apathy (DCA) into a clinician-rated questionnaire informed by interviews with the patient and caregiver.
OBJECTIVE
The goal of the present study was to compare the classification of apathy using the DCA with that using the Neuropsychiatric Inventory-apathy (NPI-apathy) subscale in ADMET 2. Comparisons between NPI-Apathy and Dementia Apathy Interview Rating (DAIR) scale, and DCA and DAIR were also explored.
METHODS
ADMET 2 is a randomized, double-blind, placebo-controlled phase III trial examining the effects of 20 mg/day methylphenidate on symptoms of apathy over 6 months in patients with mild to moderate Alzheimer's disease (AD). Participants scoring at least 4 on the NPI-Apathy were recruited. This analysis focuses on cross-sectional correlations between baseline apathy scale scores using cross-tabulation.
RESULTS
Of 180 participants, the median age was 76.5 years and they were predominantly white (92.8%) and male (66.1%). The mean (±standard deviation) scores were 7.7 ± 2.4 on the NPI-apathy, and 1.9 ± 0.5 on the DAIR. Of those with NPI-defined apathy, 169 (93.9%, 95% confidence interval [CI] 89.3%-96.9%) met DCA diagnostic criteria. The DCA and DAIR overlapped on apathy diagnosis for 169 participants (93.9%, 95% CI 89.3%-96.9%).
CONCLUSION
The measurements used for the assessment of apathy in patients with AD had a high degree of overlap with the DCA. The NPI-apathy cut-off used to determine apathy in ADMET 2 selects those likely to meet DCA criteria.",2020,"Of those with NPI-defined apathy, 169 (93.9%, 95% confidence interval [CI] 89.3%-96.9%) met DCA diagnostic criteria.","['patients with AD had a high degree of overlap with the DCA', 'median age was 76.5 years and they were predominantly white (92.8%) and male (66.1', '180 participants', ""patients with mild to moderate Alzheimer's disease (AD"", 'Participants scoring at least 4 on the NPI-Apathy were recruited']","['methylphenidate', 'placebo']","['mean (±standard deviation) scores', 'Neuropsychiatric Inventory-apathy (NPI-apathy) subscale', 'NPI-Apathy and Dementia Apathy Interview Rating (DAIR) scale, and DCA and DAIR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0185027', 'cui_str': 'Imbrication'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",180.0,0.254169,"Of those with NPI-defined apathy, 169 (93.9%, 95% confidence interval [CI] 89.3%-96.9%) met DCA diagnostic criteria.","[{'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada. Electronic address: krista.lanctot@sunnybrook.ca.'}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Vieira', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Hamadou', 'Initials': 'H', 'LastName': 'Coulibaly', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Rosenberg', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Sunnybrook Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Lerner', 'Affiliation': 'University Hospital - Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'University of Arkansas for Medical Science, Central Arkansas Veterans Healthcare System, Little Rock, AR.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Brawman-Mintzer', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, SC.'}, {'ForeName': 'Chris H', 'Initials': 'CH', 'LastName': 'van Dyck', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Anton P', 'Initials': 'AP', 'LastName': 'Porsteinsson', 'Affiliation': 'University of Rochester, Rochester, NY.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Craft', 'Affiliation': 'Wake Forest University School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Levey', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Burke', 'Affiliation': ""Banner Alzheimer's Institute, Phoenix, AZ.""}, {'ForeName': 'Jacobo E', 'Initials': 'JE', 'LastName': 'Mintzer', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston, SC.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.020']
1027,32569429,A Pilot Trial of Topical Capsaicin Cream for Treatment of Cannabinoid Hyperemesis Syndrome.,"OBJECTIVES
Patients with cannabinoid hyperemesis syndrome (CHS) present frequently to the emergency department. Previous case studies suggest dramatic symptomatic improvement with topical capsaicin treatment. This exploratory study examined the potential effectiveness of topical capsaicin in patients with nausea and vomiting due to a suspected CHS exacerbation.
METHODS
This was a double-blind, randomized placebo-controlled pilot trial. Adults who presented with vomiting suspected to be from CHS were eligible for enrollment. We excluded pregnant women and those with resolution of symptoms. Following randomization, topical 0.1% capsaicin or placebo cream was applied to the anterior abdomen in a uniform manner. The primary outcome was the severity of nausea on a visual analog scale (VAS) of 0 to 10 cm assessed at 30 minutes. Secondary outcomes were adverse events, occurrence of posttreatment vomiting, nausea by VAS at 60 minutes, and hospital admission.
RESULTS
This pilot trial enrolled 30 patients, 17 in the capsaicin arm and 13 in the placebo arm. One patient in the capsaicin arm did not tolerate treatment due to skin irritation. Mean ± SD nausea severity at 30 minutes was 4.1 ± 2.3 cm in the capsaicin arm and 6.1 ± 3.3 cm in the placebo arm (difference = -2.0 cm, 95% confidence interval [CI] = 0.2 to -4.2 cm). At 60 minutes, mean ± SD nausea severity was 3.2 ± 3.2 cm versus 6.4 ± 2.8 cm (difference = -3.2 cm, 95% CI = -0.9 to -5.4 cm). The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference = 21.1%, 95% CI = -5.6% to 47.9%). A higher proportion of capsaicin group patients (29.4% vs. 0%) had complete resolution of nausea (relative risk = 3.4, 95% CI = 1.6 to 7.1).
CONCLUSION
In this pilot trial, the application of topical capsaicin cream was associated with a significant reduction in nausea at 60 minutes but not at 30 minutes and provided more complete relief of nausea.",2020,"The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference 21.1%, 95% CI, -5.6% to 47.9%).","['Adults who presented with vomiting suspected to be from CHS were eligible for enrollment', 'patients with nausea and vomiting due to a suspected CHS exacerbation', 'pregnant women and those with resolution of symptoms', '30 patients; 17 in the capsaicin arm and 13 in the placebo arm', 'Patients with cannabinoid hyperemesis syndrome (CHS', 'Cannabinoid Hyperemesis Syndrome']","['Topical Capsaicin Cream', 'topical capsaicin', 'topical 0.1% capsaicin or placebo cream', 'topical capsaicin cream', 'capsaicin', 'placebo']","['skin irritation', 'severity of nausea on a visual analog scale (VAS) of 0-10 cm assessed at 30 minutes', 'Mean nausea severity', 'complete resolution of nausea', 'complete relief of nausea', 'nausea', 'adverse events, occurrence of post-treatment vomiting, nausea by VAS at 60 minutes, and hospital admission', 'mean nausea severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0020450', 'cui_str': 'Hyperemesis gravidarum'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",30.0,0.533538,"The percent reduction in nausea at 60 minutes from baseline was 46.0% in the capsaicin arm and 24.9% in the placebo arm (difference 21.1%, 95% CI, -5.6% to 47.9%).","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Dean', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Sabagha', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'France', 'Affiliation': 'the, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Asmar', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jo-Ann', 'Initials': 'JA', 'LastName': 'Rammal', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Beyer', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bussa', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Kaleem', 'Initials': 'K', 'LastName': 'Chaudhry', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smoot', 'Affiliation': 'and the, Frederick Memorial Hospital, Frederick, MD, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'From the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI, USA.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14062']
1028,31561960,Phase I/IIa Trial of Atorvastatin in Patients with Acute Kawasaki Disease with Coronary Artery Aneurysm.,"OBJECTIVES
To determine the safety, tolerability, pharmacokinetics, and immunomodulatory effects of a 6-week course of atorvastatin in patients with acute Kawasaki disease with coronary artery (CA) aneurysm (CAA).
STUDY DESIGN
This was a Phase I/IIa 2-center dose-escalation study of atorvastatin (0.125-0.75 mg/kg/day) in 34 patients with Kawasaki disease (aged 2-17 years) with echocardiographic evidence of CAA. We measured levels of the brain metabolite 24(S)-hydroxycholesterol (24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area before atorvastatin treatment and at 2 and 6 weeks after initiation of atorvastatin treatment.
RESULTS
A 6-week course of up to 0.75 mg/kg/day of atorvastatin was well tolerated by the 34 subjects (median age, 5.3 years; IQR, 2.6-6.4 years), with no serious adverse events attributable to the study drug. The areas under the curve for atorvastatin and its metabolite were larger in the study subjects compared with those reported in adults, suggesting a slower rate of metabolism in children. The 24-OHC levels were similar between the atorvastatin-treated subjects and matched controls.
CONCLUSIONS
Atorvastatin was safe and well tolerated in our cohort of children with acute Kawasaki disease and CAA. A Phase III efficacy trial is warranted in this patient population, which may benefit from the known anti-inflammatory and immunomodulatory effects of this drug.",2019,"(24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area before atorvastatin treatment and at 2 and 6 weeks after initiation of atorvastatin treatment.
","['Patients with Acute Kawasaki Disease with Coronary Artery Aneurysm', 'patients with acute Kawasaki disease with coronary artery (CA) aneurysm (CAA', '34 patients with Kawasaki disease (aged 2-17\xa0years) with echocardiographic evidence of CAA', 'children with acute Kawasaki disease and CAA']","['atorvastatin', 'Atorvastatin']","['24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area', 'tolerated', 'safety, tolerability, pharmacokinetics, and immunomodulatory effects', '24-OHC levels', 'safe and well tolerated', 'brain metabolite 24(S)-hydroxycholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0010051', 'cui_str': 'Aneurysm of coronary vessels'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C1842937', 'cui_str': 'Aural Atresia, Congenital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0001347', 'cui_str': 'Acute phase reactant'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C2314970', 'cui_str': 'Internal diameter'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0208133', 'cui_str': '24-hydroxycholesterol'}]",34.0,0.0151144,"(24-OHC), serum lipids, acute-phase reactants, liver enzymes, and creatine phosphokinase; peripheral blood mononuclear cell populations; and CA internal diameter normalized for body surface area before atorvastatin treatment and at 2 and 6 weeks after initiation of atorvastatin treatment.
","[{'ForeName': 'Adriana H', 'Initials': 'AH', 'LastName': 'Tremoulet', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA. Electronic address: atremoulet@ucsd.edu.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Biostatistics Research Center, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Pei-Ni', 'Initials': 'PN', 'LastName': 'Jone', 'Affiliation': ""Pediatric Cardiology, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.""}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Duxbury', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA; Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California San Diego, La Jolla, CA.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Franco', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Printz', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Dominguez', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Heizer', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Marsha S', 'Initials': 'MS', 'LastName': 'Anderson', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Glodé', 'Affiliation': ""Pediatric Infectious Disease, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'Biostatistics Research Center, Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Padilla', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Chisato', 'Initials': 'C', 'LastName': 'Shimizu', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Emelia', 'Initials': 'E', 'LastName': 'Bainto', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Pancheri', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Whitin', 'Affiliation': 'Department of Pediatrics, Stanford University, Stanford, CA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Burns', 'Affiliation': ""Kawasaki Disease Research Center, Department of Pediatrics, University of California San Diego, La Jolla, CA; Rady Children's Hospital-San Diego, San Diego, CA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.07.064']
1029,32574506,Hyperbaric oxygen and focused rehabilitation program: a feasibility study in improving upper limb motor function after stroke.,"Neuroplasticity and recovery after stroke can be enhanced by a rehabilitation program pertinent to upper limb motor function exercise and mental imagery (EMI) as well as hyperbaric oxygen therapy (HBOT). We assessed feasibility and safety of the combined approach utilizing both HBOT and EMI, and to derive preliminary estimates of its efficacy. In this randomized controlled trial, 27 patients with upper extremity hemiparesis at 3-48 months after stroke were randomized to receive either a complementary rehabilitation program of HBOT-EMI (intervention group), or EMI alone (control group). Feasibility and safety were assessed as total session attendance, duration of sessions, attrition rates, missing data, and intervention-related adverse events. Secondary clinical outcomes were assessed with both objective tools and self-reported measures at baseline, 8 weeks (end of treatment), and 12-weeks follow-up. Session attendance, duration, and attrition rate did not differ between the groups; there were no serious adverse events. Compared with baseline, there were significant sustained improvements of objective and subjective outcomes' measures in the intervention group, and a single improvement in an objective measure in the control group. Between-group outcome comparisons were not statistically significant. This study demonstrated that the combination HBOT-EMI was a safe and feasible approach in patients recovering from chronic stroke. There were also trends for improved motor function of the affected upper limb after the treatments. ClinicalTrials.gov registration no.: NCT02666469. Novelty HBOT combined with an upper limb exercise and mental imagery rehabilitation program is feasible and safe in chronic stroke patients. This combined approach showed trends for improved functional recovery.",2020,"Session attendance, duration and attrition rate did not differ between the groups; there were no serious adverse events.","['twenty-seven patients with upper extremity hemiparesis 3-48 months after stroke', 'patients recovering from chronic stroke', 'chronic stroke patients']","['HBOT combined with an upper limb exercise and mental imagery rehabilitation program', 'complementary rehabilitation program HBOT-EMI (intervention group), or EMI alone (control group', 'combination HBOT-EMI', 'hyperbaric oxygen therapy (HBOT', 'Hyperbaric Oxygen and Focused Rehabilitation Program']","['total session attendance, duration of sessions, attrition rates, missing data, and intervention-related adverse events', 'Session attendance, duration and attrition rate', 'feasibility and safety', 'Feasibility and safety', 'functional recovery', 'motor function']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454320', 'cui_str': 'Upper limb exercises'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",27.0,0.0375018,"Session attendance, duration and attrition rate did not differ between the groups; there were no serious adverse events.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schiavo', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Stroke Rehabilitation Clinic, Toronto Rehabilitation Institute, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Santa Mina', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Buryk-Iggers', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON M5G 2C1, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Uehling', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Clarke', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Djaiani', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gershinsky', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Katznelson', 'Affiliation': 'Hyperbaric Medicine Unit, Department of Anesthesia and Pain Management, Toronto General Hospital, University Health Network, Toronto, ON M5G 2C4, Canada.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0124']
1030,32583973,Trabecular bone deterioration in differentiated thyroid cancer: Impact of long-term TSH suppressive therapy.,"BACKGROUND
Conflicting results has been reported regard osteoporosis and fractures in patients with Differentiated Thyroid Cancer (DTC). Our objective was to evaluate the long-term effects of TSH suppression therapy with Levothyroxine (LT4) on trabecular bone score (TBS) and bone mineral density (BMD) in females with DTC after thyroidectomy.
METHODS
About 145 women with resected DTC and receiving long-term TSH therapy, were stratified according to the degree of TSH suppression. Mean duration of follow-up was 12.3 ± 6.1 years. BMD and TBS, were assessed using dual-energy X-ray absorptiometry (DXA) and TBS iNsight (Med-Imaps), at baseline (1-3 months after surgery) and at the final study visit.
RESULTS
In patients stratified by duration of TSH suppression therapy (Group I, 5-10 years; Group II, >10 years), slight increases from baseline TSH levels were observed. Significant decreases in LS-BMD and FN-BMD were seen in patients after >10 years. TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups). Regarding the degree of TSH suppression, TBS was significantly reduced in those with TSH < 0.1 µU/mL (P = .0086), and not in patients with TSH suppression of 0.1.-0.5 or >0.5 µU/mL.
CONCLUSIONS
We found deterioration of trabecular structure in patients with DTC and TSH suppression therapy below 0.1 µU/mL and after 5-10 years of follow-up. Significant changes in BMD according to TSH levels were not observed. Trabecular Bone Score is a useful technique for identifying thyroid cancer patients with risk of bone deterioration.",2020,"TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups).","['females with DTC after thyroidectomy', 'thyroid cancer patients with risk of bone deterioration', 'patients with Differentiated Thyroid Cancer (DTC', '145 women with resected DTC and receiving long-term TSH therapy', 'differentiated thyroid cancer']","['TSH suppression therapy', 'TSH suppression therapy with Levothyroxine (LT4', 'TSH suppressive therapy']","['trabecular bone score (TBS) and bone mineral density (BMD', 'LS-BMD and FN-BMD', 'TSH suppression, TBS', 'baseline TSH levels', 'BMD and TBS', 'Trabecular bone deterioration', 'TBS values', 'BMD according to TSH levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}]","[{'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",145.0,0.0222858,"TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Hawkins Carranza', 'Affiliation': 'Research Institute i+12, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Guadalix Iglesias', 'Affiliation': 'Thyroid Cancer Unit, Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Luisa De Mingo Domínguez', 'Affiliation': 'Hospital La Luz, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martín-Arriscado Arroba', 'Affiliation': 'Epidemiology Unit, Research Institute i+12, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'López Álvarez', 'Affiliation': 'Centro de Salud Goya, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Allo Miguel', 'Affiliation': 'Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Martínez Díaz-Guerra', 'Affiliation': 'Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}]",Cancer medicine,['10.1002/cam4.3200']
1031,32442828,Subgroup analysis of the early paracetamol trial to preterm infants found haemodynamic changes and improved oxygenation.,"BACKGROUND
We previously reported in a randomised trial that early intravenous paracetamol accelerated contraction of ductus arteriosus in very preterm infants (<32 gestation weeks).
AIMS
To monitor sequentially paracetamol effects on the blood pressure and brain tissue oxygenation in the infants participating the trial.
METHODS
In a double-blind trial, intravenous paracetamol or placebo was infused to 48 very premature infants starting within 24 h of birth for four days. Besides the ductus arteriosus, we systematically measured blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE) during the study period.
RESULTS
Compared to the placebo, the paracetamol loading dose transiently decreased the arterial blood pressure. During treatment, the paracetamol-treated infants had higher spO 2 (p = .042) and rcSO 2 (p = .036) values than the placebo group infants. Additionally, the cFTOE values were lower in the paracetamol group during the study without statistical significance. All infants with closed ductus had higher tissue oxygenation and a lower cFTOE than infants with open ductus.
CONCLUSIONS
Paracetamol caused modest haemodynamic effects and increased cerebral oxygenation. They were mostly due to early contraction of ductus. Additional direct drug-effects in brain are not ruled-out.",2020,"During treatment, the paracetamol-treated infants had higher spO 2 (p = .042) and rcSO 2 (p = .036) values than the placebo group infants.","['very preterm infants (<32 gestation weeks', '48 very premature infants starting within 24\u202fh of birth for four days', 'infants participating the trial']","['paracetamol', 'intravenous paracetamol or placebo', 'Paracetamol', 'placebo']","['haemodynamic effects', 'haemodynamic changes and improved oxygenation', 'tissue oxygenation', 'arterial blood pressure', 'blood pressure and brain tissue oxygenation', 'blood pressure, peripheral (spO 2 ) and regional cerebral oxygen saturation (rcSO 2 ), and cerebral fractional tissue oxygen extraction (cFTOE', 'cerebral oxygenation']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0440746', 'cui_str': 'Brain tissue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]",48.0,0.459725,"During treatment, the paracetamol-treated infants had higher spO 2 (p = .042) and rcSO 2 (p = .036) values than the placebo group infants.","[{'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Härmä', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Aikio', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland. Electronic address: outi.aikio@ppshp.fi.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Härkin', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Leskinen', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Valkama', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Saarela', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.'}]",Early human development,['10.1016/j.earlhumdev.2020.105042']
1032,32584168,"The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial.","Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. Objectives: To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization. Methods: Exacerbations and change from baseline in trough FEV 1 and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days. Measurements and Main Results: FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction; P < 0.001), but only a numerical reduction was seen among prior ICS nonusers (12% reduction; P = 0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce the annual on-treatment moderate/severe exacerbation rate (19%; P < 0.001) compared with UMEC/VI. The benefit of FF/UMEC/VI compared with UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users, 35% reduction; P < 0.001; non-ICS users, 35% reduction; P = 0.018), and overall when excluding the first 30 days (29%; P < 0.001). Improvements from baseline with FF/UMEC/VI compared with UMEC/VI were also maintained throughout the study for both trough FEV 1 and St. George's Respiratory Questionnaire, regardless of prior ICS use. Conclusions: These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.Clinical trial registered with www.clinicaltrials.gov (NCT02164513).",2020,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).",['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],"['inhaled corticosteroid (ICS', 'FF/UMEC/VI versus UMEC', 'fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI', 'ICS Withdrawal and Baseline Inhaled Treatment']","['severe exacerbation rates', ""trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ"", 'annual moderate/severe exacerbation rate', 'exacerbation reduction, lung function and quality of life', 'severe exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.74081,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'Division of Pulmonary and Critical Care, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine, Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, Research and Development, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Stockley Park West, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Medical Department, Pulmonary Section, Herlev-Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2478OC']
1033,32445498,Effect of Fremanezumab Monthly and Quarterly Doses on Efficacy Responses.,"OBJECTIVE
Exposure-response (E-R) models were developed to provide a description of the time-course of treatment effect for monthly and quarterly dosing regimens of fremanezumab.
BACKGROUND
Fremanezumab is a monoclonal antibody for preventive treatment of episodic migraine (EM) and chronic migraine (CM). In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM. Development of E-R models relating individual-specific measures of drug exposure to clinical endpoints provides a more granular understanding of the expected effects of different doses on therapeutic outcomes by accounting for variability in pharmacokinetic (PK) properties.
METHODS
Data from 2 phase 2b and 2 phase 3 studies of adults with EM or CM were used. Individual exposures were calculated from a population PK model and related to monthly migraine days in EM and moderate-severe (M/S) headache days in CM. Model-based stochastic simulations were performed to compare predicted responses for the various treatment regimens.
RESULTS
The effect of average fremanezumab concentration compared to placebo on the reduction in migraine days and M/S headache days was predicted by the models to be similar for 225 mg monthly and 675 mg once quarterly over time for both EM and CM patients. Both regimens were associated with better response than placebo. A similar percent of EM and CM responders was predicted across the range of observed body weights.
CONCLUSIONS
Exposure-response evaluations showed that both monthly (225 mg) and quarterly (675 mg) fremanezumab dosing regimens were appropriate in achieving clinical benefit in adult patients with EM or CM.",2020,"In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM.","['adult patients with EM or CM', 'Data from 2 phase 2b and 2 phase 3 studies of adults with EM or CM were used']","['Fremanezumab', 'fremanezumab', 'placebo']","['migraine days and M/S headache days', 'Efficacy Responses', 'migraine and headache days']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0603915,"In phase 2b and 3 clinical studies of fremanezumab, significant reductions in migraine and headache days and other clinical endpoints were observed for patients with EM and patients with CM.","[{'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fiedler-Kelly', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Passarell', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ludwig', 'Affiliation': 'Cognigen Corporation (a Simulations Plus company), Buffalo, NY, USA.'}, {'ForeName': 'Micha', 'Initials': 'M', 'LastName': 'Levi', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Cohen-Barak', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Netanya, Israel.'}]",Headache,['10.1111/head.13845']
1034,32443961,Primary Care Clinic Nurse Activities with a Telehealth Monitoring System.,"The purpose of this study was to evaluate differences in the types of nursing activities and communication processes reported in a primary care clinic between patients who used a home-based monitoring system to electronically communicate self-monitored blood glucose and blood pressure values and those who assumed usual care. Data were extracted from electronic medical records from individuals who participated in a randomized controlled trial comparing in-home monitoring and usual care in patients with Type 2 diabetes and hypertension being treated in a primary care clinic. Data about nursing activities initiated by primary care clinic nurses were compared between groups using descriptive statistics and independent t -tests. Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up. This study provides evidence of greater nursing activity reported in a primary care clinic in patients who utilized a home-based monitoring system.",2020,"Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up.","['patients with Type 2 diabetes and hypertension being treated in a primary care clinic', 'patients who utilized a home-based monitoring system', 'patients who used a home-based monitoring system to electronically communicate self-monitored blood glucose and blood pressure values and those who assumed usual care']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",[],[],,0.0129672,"Significant differences between groups were identified for the direct care nursing activities of providing lifestyle and health education, medication adjustments, and patient follow-up.","[{'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Howland', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Despins', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Jeri', 'Initials': 'J', 'LastName': 'Sindt', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Wakefield', 'Affiliation': 'Sinclair School of Nursing, University of Missouri, Columbia, MO, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Mehr', 'Affiliation': 'Curtis W. and Ann H. Long Department of Family and Community Medicine, School of Medicine, University of Missouri, Columbia, MO, USA.'}]",Western journal of nursing research,['10.1177/0193945920923082']
1035,32444619,Virtual reality clinical-experimental tests of compassion treatment techniques to reduce paranoia.,"Paranoia may build on negative beliefs held both about the self and others. Compassionate imagery may be one way of reducing such negative beliefs, and hence paranoia. Two studies tested this idea, one targeting compassion for the self and one targeting compassion for others. Two-hundred individuals from the general population scoring highly for paranoia were recruited. The studies used a randomised controlled experimental design, with embedded tests for mediation. Study one targeted self-compassion via creation of a compassionate coach (CC) image. Study two targeted compassion for others via loving kindness meditation (LKM). Individuals repeatedly entered neutral virtual reality social environments. Changes in compassion and paranoia were assessed. Compared to controls, the CC group increased in self-compassion (group difference = 2.12, C.I. = 1.57;2.67, p = <0.0001, d = 1.4) and decreased in paranoia (group difference = -1.73, C.I. = -2.48; -0.98, p = <0.0001, d = 0.8). Change in self-compassion explained 57% of change in paranoia. Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8). Change in compassion for others explained 67% of change in paranoia. Targeting negative beliefs about the self and others using compassionate imagery causes reductions in paranoia. Tests in clinical populations are indicated.",2020,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","['Two-hundred individuals from the general population scoring highly for paranoia were recruited', 'Individuals repeatedly entered neutral virtual reality social environments']",['LKM'],"['paranoia', 'Change in compassion', 'self-compassion', 'compassion']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0037414', 'cui_str': 'Social context'}]","[{'cui': 'C0024028', 'cui_str': 'Love'}]","[{'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0036588', 'cui_str': 'Self'}]",200.0,0.084631,"Compared to controls, the LKM group increased their compassion for others (group difference = 3.26, C.I. = 2.72;3.80, p = <0.0001, d = 1.7), and decreased in paranoia (group difference = -1.70, C.I. = -2.50; -0.89, p = <0.0001, d = 0.8).","[{'ForeName': 'Poppy', 'Initials': 'P', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. poppy.brown@psych.ox.ac.uk.'}, {'ForeName': 'Felicity', 'Initials': 'F', 'LastName': 'Waite', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Rovira', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]",Scientific reports,['10.1038/s41598-020-64957-7']
1036,32444629,Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial.,"Minimally invasive surgery for inguinal hernia repair is advantageous in terms of return to usual activities and lower rates of chronic pain; however, it requires general anesthesia. This study sought to analyze the benefits of ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block) as a single anesthetic technique for endoscopic totally extraperitoneal (TEP) inguinal hernia repair with regard to postoperative pain, length of hospital stay, and hospital cost. A total of 46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair. In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia. Consequently, the former group showed a briefer median hospital stay (6 versus 24 hours, respectively). The anesthesia and hospital costs were also lower for the QL block group, with median reductions of 64.15% and 25%, respectively. QL block is a safe and effective option for patients undergoing TEP inguinal hernia repair, given the observed reduction in early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs.",2020,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"['46 patients, aged 18 to 80 years, with unilateral inguinal hernia, one group that received', 'Tep) Inguinal Hernia Repair', 'patients undergoing TEP inguinal hernia repair']","['ultrasound guided locoregional anesthesia of the quadratus lumborum muscle (QL block', 'general anesthesia and one that received sedation and QL block for TEP inguinal hernia repair', 'Laparoscopic Totally Extraperitoneal', 'Minimally invasive surgery', 'QL block', 'endoscopic totally extraperitoneal (TEP) inguinal hernia repair']","['median pain score', 'Quadratus Lumborum Block', 'anesthesia and hospital costs', 'briefer median hospital stay', 'postoperative pain, length of hospital stay, and hospital cost', 'early postoperative pain, briefer hospital stay, and decreased anesthesia and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0145334', 'cui_str': 'tetraethylpyrazine'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",46.0,0.130019,In the 46 patients the median pain score 6 hours after surgery was significantly lower (2 versus 4) among the QL block group than among the group receiving general anesthesia.,"[{'ForeName': 'Murillo de Lima', 'Initials': 'ML', 'LastName': 'Favaro', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil. mlfavaro@prof.unisa.br.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Gabor', 'Affiliation': 'Professor of General Surgery and Surgical Technique at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Diogo Barros Florenzano', 'Initials': 'DBF', 'LastName': 'Souza', 'Affiliation': 'Professor of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Anderson Alcoforado', 'Initials': 'AA', 'LastName': 'Araújo', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Ana Luiza Castro', 'Initials': 'ALC', 'LastName': 'Milani', 'Affiliation': 'Fellow of Anesthesiology at the University Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Marcelo Augusto Fontenelle', 'Initials': 'MAF', 'LastName': 'Ribeiro Junior', 'Affiliation': 'Full Professor of General Surgery at the University Santo Amaro, São Paulo, Brazil.'}]",Scientific reports,['10.1038/s41598-020-65604-x']
1037,32444670,A new approach to prevent cervical stenosis in postmenopausal women after loop electrosurgical excision procedure: a randomized controlled trial.,"To determine whether regular cervical dilatation is effective for preventing cervical stenosis, and to identify the associated risk factors, in postmenopausal women after LEEP. This was a prospective randomized clinical trial in postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019. Patients who met the study criteria were randomly allocated to three groups: control group (without any intervention), intervention group A (underwent cervical dilatation at the 3 rd , 5 th , and 8 th week after LEEP) and intervention group B (underwent cervical dilatation at the 4 th , 8 th , and 12 th week after LEEP). A colposcopic follow-up examination was conducted at 6 months after LEEP to determine the incidence of cervical stenosis. A total of 404 postmenopausal women were found to be finally eligible for the study. The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group B. We found regular dilatation after LEEP in postmenopausal women can prevent cervical stenosis. Further, the 3rd, 5th, and 8th weeks after LEEP are optimal time points. Finally, LEEP frequency and resection depth are significant risk factors and can be used to screen postmenopausal women at risk for cervical stenosis after LEEP.",2020,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","['screen postmenopausal women at risk for cervical stenosis after LEEP', 'Patients who met the study criteria', 'postmenopausal women after loop electrosurgical excision procedure', 'postmenopausal women', '404 postmenopausal women were found to be finally eligible for the study', 'postmenopausal women who underwent LEEP at our hospital between August 2018 and May 2019', 'postmenopausal women after LEEP']","['regular cervical dilatation', 'control group (without any intervention), intervention group A (underwent cervical dilatation']",['rate of cervical stenosis'],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}, {'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0269199', 'cui_str': 'Stenosis of cervix'}]",404.0,0.0439457,"The rate of cervical stenosis in the control group was significantly higher than that in the intervention group, and the rate in group A was significantly lower than that in group","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhunan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. dr.wudan@163.com.'}]",Scientific reports,['10.1038/s41598-020-65170-2']
1038,32447830,650 usec 1064nm Nd:YAG laser treatment of acne: A double-blind randomized control study.,"BACKGROUND
A variety of energy-based devices have been used to treat acne. However, all studies have been subjective and have not involved double-blind and randomized controlled studies.
AIMS
We undertook a randomized controlled study evaluating the use of a 650 usec 1064 nm Nd:YAG laser compared with a sham in the treatment of acne.
PATIENTS/METHODS
A total of 20 subjects with moderate-to-severe acne were randomized to receive either 650 usec 1064nm Nd:YAG laser or sham treatment. All subjects received 3 treatments, two weeks apart, plus an additional session undertaken 4 weeks after the 3rd treatment. Subjects were evaluated for investigator global improvement, improvement in inflammatory lesions, improvement in comedonal lesions, total porphyrin score, and total sebum score.
RESULTS
The laser-treated group showed an Investigator's Global Assessment Scale (IGA) improvement of 26% compared with 7% for the sham group (a 271% improvement over sham treatment group). The treatment group also showed a decrease in the number of inflammatory lesions of 42% compared with 26% in the sham group (a 62% improvement over sham). The laser-treated cohort also experienced a reduction in total number of comedones similar to that seen with inflammatory lesions and a decrease in total porphyrin score. There was also an 18% reduction in sebum production in the treated group, compared with 9% in the sham group (a 100% improvement).
CONCLUSION
This is the first study that has compared laser treatment of acne compared with a sham treatment. A 650 usec 1064nm Nd:YAG laser can effectively treat acne.",2020,The laser-treated cohort also experienced a reduction in total number of comedones similar to that seen with inflammatory lesions and a decrease in total porphyrin score.,"['A 650 usec 1064nm', '650 usec 1064nm Nd', '650 usec 1064\xa0nm Nd', '20 subjects with moderate-to-severe acne']","['YAG laser', 'YAG laser or sham treatment', 'Nd:YAG laser', 'YAG laser treatment of acne']","['sebum production', ""Investigator's Global Assessment Scale (IGA) improvement"", 'number of inflammatory lesions', 'investigator global improvement, improvement in inflammatory lesions, improvement in comedonal lesions, total porphyrin score, and total sebum score', 'total porphyrin score', 'total number of comedones']","[{'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0439224', 'cui_str': 'us'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0036511', 'cui_str': 'Sebum'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3872830', 'cui_str': 'Inflammatory lesion'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032712', 'cui_str': 'Porphyrin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221228', 'cui_str': 'Comedone'}]",20.0,0.178718,The laser-treated cohort also experienced a reduction in total number of comedones similar to that seen with inflammatory lesions and a decrease in total porphyrin score.,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Kesty', 'Affiliation': 'Skin Laser and Surgery Specialists of NY & NJ, Hackensack, NJ, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Goldberg', 'Affiliation': 'Skin Laser and Surgery Specialists of NY & NJ, Hackensack, NJ, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13480']
1039,32443142,The Long-term Effectiveness of the Automatic Position-Adaptive System in Spinal Cord Stimulation: A Retrospective Comparative Study with a Two-Year Follow-up.,"OBJECTIVE
To compare the nonadaptive manual system with the position-adaptive system in subjects with permanent spinal cord stimulator (SCS) implantation over a two-year follow-up period.
DESIGN
Retrospective study.
SETTING
Tertiary university-based national hospital.
SUBJECTS
Patients who underwent permanent SCS implantation procedures.
METHODS
Patients were divided into an adaptive group and a nonadaptive group according to the type of implanted SCS device. The primary outcome was the change (%) in pain intensity from baseline between the adaptive and nonadaptive groups at 24 months after SCS implantation. The secondary outcomes were comparisons of detailed clinical variables such as the scores of patient pain and satisfaction during the two-year follow-up after SCS therapy. Further, the number of subjects with SCS removal or revision within two years after SCS implantation was investigated.
RESULTS
Of 187 patients with permanent SCS implantation, 85 in the nonadaptive group and 64 in the position-adaptive group were finally analyzed. The reduction in pain intensity at 24 months was higher in the adaptive group (-38.6%) than in the nonadaptive group (-30.8%, P = 0.05). Similarly, patient satisfaction with the SCS treatment at 24 months was superior in the adaptive group than in the nonadaptive group (85.7% vs 67.5% were satisfied in each group, respectively, P = 0.024). During the two years, 5.3% of patients (N = 10) underwent SCS removal and 7.0% (N = 13) underwent revision procedures.
CONCLUSIONS
There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.",2020,"There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.","['Tertiary university-based national hospital', 'Patients', '187 patients with permanent SCS implantation, 85 in the nonadaptive group and 64 in the position-adaptive group were finally analyzed', 'subjects with permanent spinal cord stimulator (SCS) implantation over a two-year follow-up period', 'Patients who underwent permanent SCS implantation procedures', 'Spinal Cord Stimulation']","['Automatic Position-Adaptive System', 'nonadaptive group according to the type of implanted SCS device']","['change (%) in pain intensity', 'pain intensity', 'patient satisfaction', 'scores of patient pain and satisfaction']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449497', 'cui_str': 'Type of device'}, {'cui': 'C0037925', 'cui_str': 'Spinal cord structure'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",187.0,0.0470401,"There was a trend of a sustained reduction in pain intensity as well as improvement in patient satisfaction at two-year follow-up in the position-adaptive system, suggesting long-term benefit over the nonadaptive manual system during SCS treatment.","[{'ForeName': 'Eun Kyoung', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chang-Soon', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yongjae', 'Initials': 'Y', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Jung Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Youngwon', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jee Youn', 'Initials': 'JY', 'LastName': 'Moon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa121']
1040,32452659,"Pharmacokinetics and Bioequivalence of Clopidogrel Hydrogen Sulfate Tablets in Fed and Fasted Conditions: An Open-Label, Randomized, Semireplicated Crossover Study in Healthy Chinese Volunteers.","Clopidogrel is an antiplatelet drug with high intraindividual variability in systemic exposure and efficacy. It has been used for treating atherosclerosis and acute coronary syndrome and in preventing stent restenosis and thrombotic complications after stent implantation in clinical practice for nearly 20 years. In this study we aimed to evaluate the bioequivalence of 2 clopidogrel hydrogen sulfate formulations (75-mg tablets) under fed (n = 66) and fasted (n = 66) conditions by using the reference-scaled average bioequivalence method. An open-label, randomized, 3-sequence and 3-period crossover (3×3), semireplicated study was designed and conducted. Clopidogrel concentration of plasma samples was measured by high-precision liquid chromatography and tandem mass spectrometry. The pharmacokinetic parameters were derived by a noncompartmental model. In the fed condition the geometric least-squares mean ratios of peak concentration (C max ) and area under the concentration-time curve (AUC 0-t ) were, respectively, 103.38% and 98.97%, and the corresponding 90%CIs were 95.68% to 111.70% and 94.67% to 103.47%. In the fasted condition the geometric least squares mean ratios of C max and AUC 0-t were, respectively, 106.53% and 105.77%, and the corresponding 90%CIs were 97.62% to 116.25% and 96.96% to 115.38%. According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.",2020,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","['Fed and Fasted Conditions', 'Healthy Chinese Volunteers']","['clopidogrel hydrogen sulfate formulations', 'Clopidogrel Hydrogen Sulfate Tablet', 'Clopidogrel']","['geometric least squares mean ratios of C max and AUC 0-t', 'Clopidogrel concentration of plasma samples', 'geometric least-squares mean ratios of peak concentration (C max ) and area under the concentration-time curve (AUC 0-t ']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0772326', 'cui_str': 'Clopidogrel bisulfate'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",66.0,0.0275802,"According to the criteria for bioequivalence (80.00% to 125.00%), the test formulations of clopidogrel and Plavix were determined to be bioequivalent.","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Shili', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital Capital Medical University, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.804']
1041,32447618,Excess volume removal following lung ultrasound evaluation decreases central blood pressure and pulse wave velocity in hemodialysis patients: a LUST sub-study.,"BACKGROUND
Arterial stiffness is a strong predictor of death and cardiovascular (CV) events in hemodialysis patients. Only few studies tested interventions aiming to improve arterial stiffness in this population. This study examines the effect of dry-weight reduction with a standardized lung-ultrasound-guided strategy on ambulatory aortic blood pressure (BP) and arterial stiffness parameters in hemodialysis.
METHODS
Seventy-one clinically euvolemic hemodialysis patients with hypertension, were included in this single-blind randomized clinical-trial. Patients were randomized in the active group (n = 35), following dry-weight reduction guided by the total number of US-B lines before a mid-week dialysis session and the control group (n = 36), following standard treatment. Patients underwent office evaluation of arterial stiffness and 48-h ABPM to capture ambulatory central systolic (cSBP) and diastolic BP (cDBP) and arterial stiffness indexes at baseline and after 8-weeks.
RESULTS
US-B lines decreased in the active and slightly increased in the control group (p < 0.001) during follow-up. Office-pulse-wave-velocity (PWV) decreased from baseline to study-end only in the active group, resulting in significant between-group differences (- 0.25 ± 0.71 vs 0.20 ± 1.18 m/s p = 0.037). Reduction in 48-h-cSBP (- 6.30 ± 8.90 vs - 0.50 ± 12.46; p = 0.027) was greater and in cDBP (- 3.85 ± 6.61 vs - 0.63 ± 8.36; p = 0.077) marginally greater in the active compared to control group. 48-h-central-pulse-pressure (cPP, 41.51 ± 9.63 vs 39.06 ± 9.61 mmHg; p = 0.004) and 48-h-PWV (9.30 ± 2.00 vs 9.08 ± 2.04 m/s p = 0.032) were significantly reduced during follow-up in the active group and were unchanged in controls, resulting in significant between-group differences. In contrast, 48-h-AIx and AIx(75) were not different between the two groups.
CONCLUSION
Lung-ultrasound-guided dry-weight reduction decreased ambulatory aortic-BP and ambulatory or office-PWV, but not ambulatory-AIx(75). These results suggest that dry-weight reduction is an important treatment approach to improve these cardiovascular risk factors in hemodialysis.",2020,"RESULTS
US-B lines decreased in the active and slightly increased in the control group (p < 0.001) during follow-up.","['Seventy-one clinically euvolemic hemodialysis patients with hypertension', 'hemodialysis patients', 'hemodialysis']","['lung ultrasound evaluation', 'Lung-ultrasound-guided dry-weight reduction', 'dry-weight reduction with a standardized lung-ultrasound-guided strategy']","['ambulatory aortic-BP and ambulatory or office-PWV', 'death and cardiovascular (CV) events', 'ambulatory aortic blood pressure (BP) and arterial stiffness parameters', 'arterial stiffness', 'arterial stiffness and 48-h ABPM to capture ambulatory central systolic (cSBP) and diastolic BP (cDBP) and arterial stiffness indexes', '48-h-PWV', 'cardiovascular risk factors', 'central blood pressure and pulse wave velocity', 'cDBP', 'Office-pulse-wave-velocity (PWV']","[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0456180', 'cui_str': 'Aortic pressure'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",71.0,0.0450903,"RESULTS
US-B lines decreased in the active and slightly increased in the control group (p < 0.001) during follow-up.","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ekart', 'Affiliation': 'Department of Nephrology, University Clinical Centre Maribor, Maribor, Slovenia.'}, {'ForeName': 'Marieta', 'Initials': 'M', 'LastName': 'Theodorakopoulou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Minopoulou', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Pagourelias', 'Affiliation': '3rd Department of Cardiology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Douma', 'Affiliation': '3rd Department of Internal Medicine, Papageorgiou Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Asterios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': '2nd Propaedeutic Department of Internal Medicine, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Mallamaci', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Zoccali', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'London', 'Affiliation': 'Hospital and FCRIN INI-CRCTC, Manhes, France.'}, {'ForeName': 'Pantelis A', 'Initials': 'PA', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. psarafidis11@yahoo.gr.'}]",Journal of nephrology,['10.1007/s40620-020-00745-w']
1042,32453453,Ultra-Early Blood Pressure Reduction Attenuates Hematoma Growth and Improves Outcome in Intracerebral Hemorrhage.,"OBJECTIVE
The aim was to investigate whether intensive blood pressure treatment is associated with less hematoma growth and better outcome in intracerebral hemorrhage (ICH) patients who received intravenous nicardipine treatment ≤2 hours after onset of symptoms.
METHODS
A post-hoc exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) trial was performed. This was a multicenter, international, open-label, randomized clinical trial, in which patients with primary ICH were allocated to intensive versus standard blood pressure treatment with nicardipine ≤4.5 hours after onset of symptoms. We have included 913 patients with complete imaging and follow-up data in the present analysis.
RESULTS
Among the 913 included patients, 354 (38.7%) had intravenous nicardipine treatment initiated within 2 hours. In this subgroup of patients treated within 2 hours, the frequency of ICH expansion was significantly lower in the intensive blood pressure reduction group compared with the standard treatment group (p = 0.02). Multivariable analysis showed that ultra-early intensive blood pressure treatment was associated with a decreased risk of hematoma growth (odds ratio, 0.56; 95% confidence interval [CI], 0.34-0.92; p = 0.02), higher rate of functional independence (odds ratio, 2.17; 95% CI, 1.28-3.68; p = 0.004), and good outcome (odds ratio, 1.68; 95% CI, 1.01-2.83; p = 0.048) at 90 days. Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
INTERPRETATION
In a subgroup of ICH patients with elevated blood pressure given intravenous nicardipine ≤2 hours after onset of symptoms, intensive blood pressure reduction was associated with reduced hematoma growth and improved functional outcome. ANN NEUROL 2020;88:388-395.",2020,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","['Intracerebral Hemorrhage', '913 patients with complete imaging and follow-up data in the present analysis', 'ICH patients who received intravenous', 'patients with primary ICH']","['intensive blood pressure treatment', 'intensive versus standard blood pressure treatment with nicardipine', 'Ultra-early Blood Pressure Reduction', 'nicardipine']","['hematoma growth and improved functional outcome', 'modified Rankin Scale score distribution', 'rate of functional independence', 'Ultra-early intensive blood pressure reduction', 'elevated blood pressure', 'risk of hematoma growth', 'frequency of ICH expansion', 'intensive blood pressure reduction']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}]",913.0,0.129574,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04).
","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Warren', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St. Cloud, MN, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morotti', 'Affiliation': 'Department of Neurology and Neurorehabilitation, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Department of Medicine (Neurology), Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",Annals of neurology,['10.1002/ana.25793']
1043,32459070,Distinct peripheral blood molecular signature emerges with successful tacrolimus withdrawal in kidney transplant recipients.,"Tacrolimus (Tac) is an effective anti-rejection agent in kidney transplantation, but its off-target effects make withdrawal desirable. Although studies indicate that Tac can be safely withdrawn in a subset of kidney transplant recipients, immune mechanisms that underlie successful vs unsuccessful Tac removal are unknown. We performed microarray analyses of peripheral blood mononuclear cells (PBMC) RNA from subjects enrolled in the Clinical Trials in Organ Transplantation-09 study in which we randomized stable kidney transplant recipients to Tac withdrawal or maintenance of standard immunosuppression beginning 6 months after transplant. Eight of 14 subjects attempted but failed withdrawal, while six developed stable graft function for ≥2 years on mycophenolate mofetil plus prednisone. Whereas failed withdrawal upregulated immune activation genes, successful Tac withdrawal was associated with a downregulatory and proapoptotic gene program enriched within T cells. Functional analyses suggested stronger donor-reactive immunity in subjects who failed withdrawal without evidence of regulatory T cell dysfunction. Together, our data from a small, but unique, patient cohort support the conclusion that successful Tac withdrawal is not simply due to absence of donor-reactive immunity but rather is associated with an active immunological process.",2020,Functional analyses suggested stronger donor-reactive immunity in subjects who failed withdrawal without evidence of regulatory T cell dysfunction.,"['subjects who failed withdrawal without evidence of regulatory T cell dysfunction', 'subjects enrolled in the Clinical Trials in Organ Transplantation-09 study in which we randomized stable kidney transplant recipients to Tac withdrawal or maintenance of standard immunosuppression beginning 6 months after transplant', 'kidney transplant recipients']","['Tacrolimus (Tac', 'mycophenolate mofetil plus prednisone']",['stable graft function'],"[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",14.0,0.0229915,Functional analyses suggested stronger donor-reactive immunity in subjects who failed withdrawal without evidence of regulatory T cell dysfunction.,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Cravedi', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fribourg', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Zhengzi', 'Initials': 'Z', 'LastName': 'Yi', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zaslavsky', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Nudelman', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Anderson', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hartzell', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Brouard', 'Affiliation': 'Centre de Recherche en Transplantation et Immunologie, Université de Nantes, CHU Nantes, Inserm, Nantes, France.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Heeger', 'Affiliation': 'Department of Medicine, Icahn School of Medicine at Mount Sinai, Translational Transplant Research Center, New York, New York, USA.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.15979']
1044,32451735,The effect of forskolin on membrane clock and calcium clock in the hypoxic/reoxygenation of sinoatrial node cells and its mechanism.,"BACKGROUND
In this study, we investigated the effect of forskolin (FSK, a selective adenylate cyclase agonist) on the automatic diastolic depolarization of sinus node cells (SNC) with hypoxia/reoxygenation (H/R) injury.
METHODS
The SNC of the newborn rat was randomly assigned into the control group, the H/R (H/R injury) group, or the H/R + FSK (H/R injury + FSK treatment) group. Patch-clamp was performed to record the action potential and electrophysiological changes. The cellular distribution of intracellular calcium concentration was analyzed by fluorescence staining.
RESULTS
Compared with the control cells, spontaneous pulsation frequency (SPF) and diastolic depolarization rate (DDR) of H/R cells were reduced from 244.3 ± 10.6 times/min and 108.7 ± 7.8 mV/s to 130.5 ± 7.6 times/min and 53.4 ± 6.5 mV/s, respectively. FSK significantly increased SPF and DDR of H/R cells to 208.3 ± 8.3 times/min and 93.2 ± 8.9 mV/s (n = 15, both p < 0.01), respectively. H/R reduced the current densities of I f , I Ca,T and inward I NCX , which were significantly increased by 10 μM FSK treatment (n = 15, p < 0.01). Furthermore, reduced expression of HCN4 and NCX1.1 channel protein were significantly increased by FSK. Inhibitor studies showed that both SQ22536 (a selective adenylate cyclase inhibitor) and H89 (a selective protein kinases A [PKA] inhibitor) blocked the effects of FSK on SPF and DDR.
CONCLUSIONS
H/R causes pacemaker dysfunction in newborn rat sinoatrial node cells leading to divergence of the DD and the slow of spontaneous APs, which change can be dramatically reversed by FSK through increasing I NCX and I f current in H/R injury.",2020,H/R reduced the current densities of I,[],"['forskolin (FSK', 'Patch-clamp', 'forskolin', 'FSK', 'SQ22536']","['spontaneous pulsation frequency (SPF) and diastolic depolarization rate (DDR) of H/R cells', 'reduced expression of HCN4 and NCX1.1 channel protein', 'SPF and DDR of H/R cells', 'cellular distribution of intracellular calcium concentration']",[],"[{'cui': 'C0917964', 'cui_str': 'Coleonol'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0276004,H/R reduced the current densities of I,"[{'ForeName': 'Jian-Cheng', 'Initials': 'JC', 'LastName': 'Zhang', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Xiao-Ting', 'Initials': 'XT', 'LastName': 'Xie', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Hong-Lin', 'Initials': 'HL', 'LastName': 'Wu', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiology, General Hospital of People's Liberation Army, Haidian District, No. 28 Fuxing Road, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, General Hospital of People's Liberation Army, Haidian District, No. 28 Fuxing Road, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'National Heart Research Institute, Singapore, Singapore.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, General Hospital of People's Liberation Army, Haidian District, No. 28 Fuxing Road, Beijing, 100853, People's Republic of China. liyangbsh@163.com.""}, {'ForeName': 'Peng-Li', 'Initials': 'PL', 'LastName': 'Zhu', 'Affiliation': ""Provincial Clinical Medicine College of Fujian Medical University, No. 134 East Street, Gulou District, Fuzhou, Fujian, 350000, People's Republic of China. zpl7755@126.com.""}]",Pharmacological reports : PR,['10.1007/s43440-020-00094-2']
1045,32445440,Remdesivir for the Treatment of Covid-19 - Final Report.,"BACKGROUND
Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.
METHODS
We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.
RESULTS
A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).
CONCLUSIONS
Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).",2020,"CONCLUSIONS
Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","['1059 patients (538 assigned to remdesivir and 521 to', 'adults hospitalized with Covid-19 and evidence of lower respiratory tract infection', '1063 patients underwent randomization', 'adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement']","['remdesivir', 'intravenous remdesivir', 'placebo']","['median recovery time', 'time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only', 'Serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0085557', 'cui_str': 'Infection control procedure'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1063.0,0.687871,"CONCLUSIONS
Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection.","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Beigel', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Tomashek', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lori E', 'Initials': 'LE', 'LastName': 'Dodd', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Aneesh K', 'Initials': 'AK', 'LastName': 'Mehta', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Barry S', 'Initials': 'BS', 'LastName': 'Zingman', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Kalil', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hohmann', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Luetkemeyer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kline', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Lopez de Castilla', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Finberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Dierberg', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Tapson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Hsieh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Patterson', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Paredes', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Sweeney', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Short', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Giota', 'Initials': 'G', 'LastName': 'Touloumi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'David Chien', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Ohmagari', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Myoung-Don', 'Initials': 'MD', 'LastName': 'Oh', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Guillermo M', 'Initials': 'GM', 'LastName': 'Ruiz-Palacios', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Fätkenheuer', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Kortepeter', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Atmar', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'C Buddy', 'Initials': 'CB', 'LastName': 'Creech', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Abdel G', 'Initials': 'AG', 'LastName': 'Babiker', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Burgess', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Bonnett', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Green', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Mat', 'Initials': 'M', 'LastName': 'Makowski', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Osinusi', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nayak', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': 'H Clifford', 'Initials': 'HC', 'LastName': 'Lane', 'Affiliation': 'From the National Institute of Allergy and Infectious Diseases, National Institutes of Health (J.H.B., K.M.T., L.E.D., S.N., H.C.L.), and the Infectious Disease Clinical Research Program, Uniformed Services University of the Health Sciences (T.H.B.), Bethesda, the Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick (T. Bonnett), and Emmes, Rockville (M.G., M.M.) - all in Maryland; Emory University, Atlanta (A.K.M.); Montefiore Medical Center-Albert Einstein College of Medicine (B.S.Z.) and NYU Langone Health and NYC Health and Hospitals-Bellevue (K.D.), New York; University of Nebraska Medical Center, Omaha (A.C.K., M.G.K.); Massachusetts General Hospital, Boston (E.H.), and University of Massachusetts Medical School, Worcester (R.W.F.); University of Washington, Seattle (H.Y.C.), and Evergreen Health Medical Center, Kirkland (D.L.C.) - both in Washington; University of California, San Francisco, San Francisco (A.L.), Cedars-Sinai Medical Center, Los Angeles (V.T.), University of California, Irvine, Irvine (L.H.), University of California, San Diego, La Jolla (D.A.S.), and Gilead Sciences, Foster City (A.O.) - all in California; University of Minnesota (S.K.) and University of Minnesota School of Public Health and INSIGHT (J.D.N.), Minneapolis; University of Texas Health San Antonio, University Health System, and the South Texas Veterans Health Care System, San Antonio (T.F.P.), and Baylor College of Medicine, Houston (R.L.A.); Hospital Germans Trias i Pujol and irsiCaixa AIDS Research Institute, Badalona, Spain (R.P.); University of Pennsylvania, Philadelphia (W.R.S.); Medical School, National and Kapodistrian University of Athens, Athens (G.T.); National Center for Infectious Diseases-Tan Tock Seng Hospital-Lee Kong Chian School of Medicine-Yong Loo Lin School of Medicine, Singapore, Singapore (D.C.L.); the National Center for Global Health and Medicine Hospital, Tokyo (N.O.); Seoul National University Hospital, Seoul, South Korea (M.O.); Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City (G.M.R.-P.); the Department of Infectious Diseases, Amager Hvidovre Hospital-University of Copenhagen, Hvidovre (T. Benfield), and Rigshospitalet, Department of Infectious Diseases (CHIP) and INSIGHT, Copenhagen (J.L.) - both in Denmark; University Hospital of Cologne, Cologne, Germany (G.F.); Vanderbilt University Medical Center, Nashville (C.B.C.); and University College London, MRC Clinical Trials Unit at UCL and INSIGHT, London (A.G.B., S.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2007764']
1046,32452549,Lanadelumab demonstrates rapid and sustained prevention of hereditary angioedema attacks.,"BACKGROUND
Lanadelumab demonstrated efficacy in preventing hereditary angioedema (HAE) attacks in the phase 3 HELP Study.
OBJECTIVE
To assess time to onset of effect and long-term efficacy of lanadelumab, based on exploratory findings from the HELP Study.
METHODS
Eligible patients with HAE type I/II received lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo. Ad hoc analyses evaluated day 0-69 findings using a Poisson regression model accounting for overdispersion. Least-squares mean monthly HAE attack rate for lanadelumab was compared with placebo. Intrapatient comparisons for days 0-69 versus steady state (days 70-182) used a paired t test for continuous endpoints or Kappa statistics for categorical endpoints.
RESULTS
One hundred twenty-five patients were randomized and treated. During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) vs placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs 1.66) and moderate/severe attacks (0.31-0.48 vs 1.33, all P ≤ .001). More patients receiving lanadelumab vs placebo were attack free (37.9%-48.1% vs 7.3%) and responders (85.7%-100% vs 26.8%). During steady state, the efficacy of lanadelumab vs placebo was similar or improved vs days 0-69. Intrapatient differences were significant with lanadelumab 300 mg q4wks for select outcomes. Lanadelumab efficacy was durable-HAE attack rate was consistently lower vs placebo, from the first 2 weeks of treatment through study end. Treatment emergent adverse events were comparable during days 0-69 and 70-182.
CONCLUSION
Protection with lanadelumab started from the first dose and continued throughout the entire study period.",2020,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","['125 patients', 'Eligible patients with HAE type I/II received']","['placebo', 'Lanadelumab', 'lanadelumab', 'lanadelumab 150 mg every 4 weeks (q4wks), 300 mg q4wks, 300 mg q2wks, or placebo', 'lanadelumab versus placebo']","['durable-HAE attack rate', 'mean monthly attack rate', 'attacks requiring acute treatment', 'HAE attack rate', 'moderate/severe attacks', 'attack free']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4505508', 'cui_str': 'lanadelumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",125.0,0.120587,"During days 0-69, mean monthly attack rate was significantly lower with lanadelumab (0.41-0.76) versus placebo (2.04), including attacks requiring acute treatment (0.33-0.61 vs. 1.66) and moderate/severe attacks (0.31-0.48 vs. 1.33, all P ≤ 0.001).","[{'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology/Allergy Section, Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Longhurst', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge and University College London Hospitals, London, UK.""}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, P.C., Chevy Chase, MD, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'Salomé', 'Initials': 'S', 'LastName': 'Juethner', 'Affiliation': 'Shire, a Takeda company, Lexington, MA, USA.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy and Asthma Research Associates, Dallas, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Allergy,['10.1111/all.14416']
1047,32451220,Effectiveness of a communication skills training program for medical students to identify patients communicative clues.,"OBJECTIVE
This study explores whether an Experiential Training Programme (ETP) in communication skills (CS) improves students' ability to identify patients clues compared to those who follow a non-experiential training throughout their medical studies.
METHOD
Intervention Group (IG): 85 4th-year medical students who received the ETP and Control Group (CG): 67 recently graduated students who did not receive it. Their immediate (written) response was requested to three expressions offered by patients containing communicative clues. The answers were grouped into 2 categories: Clue recognised and response patient-centred and the opposite. Three researchers analysed the answers.
RESULTS
Responses 366 (65 from the CG and 77 from the IG): 280 did not recognise clues: 131 (62%) in IG and 149 (96%) in CG and 86 recognised them: 80 (37.9%) in IG and 6 (3.9%) in CG (p = 0.000). Some clues were more elusive than others (p = 0,003).
CONCLUSIONS
The students who received the ETP in CS showed greater ability to explore patients perspective taking advantage of different types of communicative clues than those who did not receive it in a non-relational context.
PRACTICE IMPLICATIONS
Further research is needed to assess whether this ability is maintained in simulated or real clinical situations.",2020,"Some clues were more elusive than others (p = 0,003).
","['Intervention Group (IG): 85 4th-year medical students who received the', 'medical students to identify patients communicative clues']","['Experiential Training Programme (ETP) in communication skills (CS', 'ETP and Control Group (CG): 67 recently graduated students who did not receive it', 'communication skills training program', 'ETP in CS']",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1269815', 'cui_str': 'Patient identification'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0212889,"Some clues were more elusive than others (p = 0,003).
","[{'ForeName': 'Roger Ruiz', 'Initials': 'RR', 'LastName': 'Moral', 'Affiliation': 'School of Medicine, Universidad Francisco de Vitoria, Madrid, Spain; Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, University, Córdoba, Spain. Electronic address: r.ruiz.prof@ufv.es.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andrade-Rosa', 'Affiliation': 'Department of Primary Care, Los Castillos Health Centre, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Juan D Molina', 'Initials': 'JDM', 'LastName': 'Martín', 'Affiliation': 'Department of Psychiatry, Villaverde Mental Health Centre, Hospital 12 De Octubre, Madrid, Spain.'}, {'ForeName': 'Emilio Cervera', 'Initials': 'EC', 'LastName': 'Barba', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}, {'ForeName': 'Luis Pérula', 'Initials': 'LP', 'LastName': 'de Torres', 'Affiliation': 'Department of Primary Care Córdoba, Instituto Maimónides De Investigación Biomédica De Córdoba (IMIBIC), Córdoba University, Córdoba, Spain.'}, {'ForeName': 'Diana Monge', 'Initials': 'DM', 'LastName': 'Martín', 'Affiliation': 'School of Medicine, Universidad Francisco De Vitoria, Madrid, Spain.'}]",Patient education and counseling,['10.1016/j.pec.2020.05.018']
1048,32463593,Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects.,"Sildenafil citrate is approved to treat erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate that does not require swallowing or administration with fluids has been developed. The bioequivalence and bioavailability of sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets (50 mg) in an open-label, randomized crossover study. Healthy Chinese male subjects (n = 36) were allocated to 1 of 6 sildenafil citrate treatment sequences under fasted conditions, and plasma samples for determination of sildenafil concentrations were collected predose through 14 hours postdose. Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil AUC last , C max , and AUC inf (ratio, 101.41%; 90%CI, 95.49%-107.70%; ratio, 93.55%; 90%CI, 84.15%-104.00%; and ratio, 101.03%; 90%CI, 94.80%-107.66%; respectively) were wholly contained within the bioequivalence acceptance range of 80% to 125%, indicating bioequivalence criteria were met. Relative bioavailability of sildenafil citrate ODT administered with water to the sildenafil citrate tablet (50 mg) administered with water was 97.10%, 91.43%, and 97.09% with respect to sildenafil AUC last , C max , and AUC inf , respectively (90%CI, 91.43%-03.12%, 82.25%-101.65%, and 90.90%-103.71%, respectively). Both sildenafil citrate formulations were generally well tolerated in healthy Chinese men. Sildenafil citrate ODT administered without or with water was bioequivalent to or met bioequivalence criteria compared with conventional sildenafil citrate tablets administered with water under fasted conditions in healthy Chinese men, thus offering a convenient alternative method of oral administration.",2020,Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil,"['Healthy Chinese male subjects (n = 36', 'healthy Chinese men', 'Healthy Chinese Male Subjects']","['sildenafil citrate tablet', 'sildenafil citrate ODT', 'Sildenafil citrate ODT', 'conventional sildenafil citrate tablets', 'sildenafil AUC', 'sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets', 'sildenafil citrate formulations', 'Sildenafil citrate', 'sildenafil citrate', 'Sildenafil Citrate', 'sildenafil']","['Relative bioavailability', 'AUC last , C max , and AUC inf', 'Bioequivalence and Bioavailability', 'last , C max , and AUC inf']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C2960508', 'cui_str': 'Orodispersible tablet'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",36.0,0.0744477,Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Peking University First Hospital, Institute of Clinical Pharmacology, Beijing, China.'}, {'ForeName': 'Bin-Yu', 'Initials': 'BY', 'LastName': 'Luo', 'Affiliation': 'Pfizer Inc, Shanghai, China.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'LaBadie', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Inc, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Pfizer Inc, Beijing, China.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Ernst', 'Affiliation': 'ExecuPharm, King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Penelope H', 'Initials': 'PH', 'LastName': 'Crownover', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Qinying', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.806']
1049,32463618,"Treatment of Chronic Abdominal Pain With 10-kHz Spinal Cord Stimulation: Safety and Efficacy Results From a 12-Month Prospective, Multicenter, Feasibility Study.","INTRODUCTION
Chronic abdominal pain (CAP) can arise from multiple conditions, including inflammatory disorders, trauma because of injury or surgery, or structural or functional causes. This prospective, single-arm study was designed to evaluate the safety and efficacy of 10-kHz spinal cord stimulation (SCS) in patients with intractable CAP over a 12-month follow-up period.
METHODS
Subjects with CAP who had been refractory to conventional medical treatment for at least 3 months resulting in self-reported pain scores of ≥5 cm on a 10-cm visual analog scale were enrolled at 4 centers in the United States. Study subjects underwent a trial stimulation lasting up to 14 days with epidural leads implanted from the vertebral levels T4 through T8. Subjects who had ≥40% pain relief during the trial stimulation period were implanted with a Senza system (Nevro Corp., Redwood City, CA) and followed up to 12 months after surgery.
RESULTS
Twenty-three of 24 subjects (95.8%) had a successful trial stimulation and proceeded to a permanent implant. After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ≥50%) and 14 of 22 subjects (63.6%) were remitters (sustained ≤3.0-cm visual analog scale scores). Secondary outcomes, including assessments of disability, mental and physical well-being, sleep quality, perception of improvement, and satisfaction, showed that 10-kHz SCS greatly improved the quality of life of patients with CAP. Observationally, most subjects also reported concurrent reduction or resolution of nausea and/or vomiting.
DISCUSSION
10-kHz SCS can provide durable pain relief and improve the quality of life in patients with CAP.",2020,"After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ≥50%) and 14 of 22 subjects (63.6%) were remitters (sustained ≤3.0-cm visual analog scale scores).","['Subjects with CAP who had been refractory to conventional medical treatment for at least 3 months resulting in self-reported pain scores of ≥5 cm on a 10-cm visual analog scale were enrolled at 4 centers in the United States', 'patients with CAP', 'Twenty-three of 24 subjects (95.8%) had a successful trial stimulation and proceeded to a permanent implant', 'Subjects who had ≥40', 'patients with intractable CAP over a 12-month follow-up period']","['Senza system (Nevro Corp., Redwood City, CA', '10-kHz Spinal Cord Stimulation', '10-kHz spinal cord stimulation (SCS', '10-kHz SCS']","['quality of life', 'assessments of disability, mental and physical well-being, sleep quality, perception of improvement, and satisfaction', 'pain relief', 'nausea and/or vomiting', 'quality of life of patients with CAP', 'safety and efficacy', 'responders (pain relief', 'durable pain relief']","[{'cui': 'C0232491', 'cui_str': 'Chronic abdominal pain'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1002377', 'cui_str': 'Redwood'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232491', 'cui_str': 'Chronic abdominal pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",24.0,0.102048,"After 12 months of treatment with 10-kHz SCS, 78.3% of subjects were responders (pain relief of ≥50%) and 14 of 22 subjects (63.6%) were remitters (sustained ≤3.0-cm visual analog scale scores).","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': ""Carolina's Pain Institute, Winston-Salem, North Carolina, USA.""}, {'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Gupta', 'Affiliation': 'Kansas Pain Management, Overland Park, Kansas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Paicius', 'Affiliation': 'Newport Beach Headache and Pain, Newport Beach, California, USA.'}, {'ForeName': 'Wyndam', 'Initials': 'W', 'LastName': 'Strodtbeck', 'Affiliation': 'Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Vorenkamp', 'Affiliation': 'Department of Anesthesiology, Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gilmore', 'Affiliation': ""Carolina's Pain Institute, Winston-Salem, North Carolina, USA.""}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Gliner', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Rotte', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}, {'ForeName': 'Jeyakumar', 'Initials': 'J', 'LastName': 'Subbaroyan', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Province-Azalde', 'Affiliation': 'Clinical Research, Nevro Corp., Redwood City, California, USA.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000133']
1050,32460220,Ultrasound imaging evaluation of structural and textural features in asymptomatic achilles tendons in pre-professional dancers: A cross-sectional study.,"OBJECTIVE
To evaluate performance descriptors, sociodemographics variables and tendon echogenicity of asymptomatic Achilles tendons and to compare the echotexture from different classification subgroups.
DESIGN
A prospective, randomized cross-sectional study was carried out.
SETTING
laboratory of university.
PARTICIPANTS
Forty-two Achilles tendons (AT) were recruited from pre-professional dancers. Based on the echogenicity pattern, the sample was divided into two groups (n = 21, Heterogeneous group; n = 21, Homogeneous group).
MAIN OUTOCOME MEASURES
Ultrasound images and ImageJ measurements were performed to evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test were measured as performance parameter.
RESULTS
EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups. AT-TH, endurance test, balance test, years of dance, training hours per week and average pointe hours per week did not showed differences between groups. A multivariate prediction model between groups and the echotexture variables (EI (R 2 = 0.569; EV (R 2 = 0.341)) were determined.
CONCLUSION
Asymptomatic AT of heterogeneous group showed a lower EI and a higher EV compared to homogeneous group. Tendon echogenicity did not interact with performance variables.",2020,"RESULTS
EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","['laboratory of university', 'Forty-two Achilles tendons (AT) were recruited from pre-professional dancers', 'asymptomatic achilles tendons in pre-professional dancers']",[],"['evaluate thickness (AT-TH), echointensity (EI) and echovariation (EV), in addition to a balance and endurance test', 'Tendon echogenicity']","[{'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}]",[],"[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",,0.0279145,"RESULTS
EI (p = 0.001) and EV (p = 0.001) reported statistically significant differences between groups.","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'De-la-Cruz-Torres', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: bcruz@us.es.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Barrera-García-Martín', 'Affiliation': 'Department of Physiotherapy, University of Seville, c/ Avicena s/n, 41009, Seville, Spain. Electronic address: irebargar@gmail.com.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Almazán-Polo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: jaime.almazan@universidadeuropea.es.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Jaén-Crespo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: gjaencrespo@gmail.com.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Romero-Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, c/Tajo s/n, Villaviciosa de Odón, 28670, Madrid, Spain. Electronic address: carlos.romero@universidadeuropea.es.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.05.008']
1051,32580914,Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal: A Proof of Concept Study.,"BACKGROUND
Hypersexuality and hyposexuality occur frequently, often in a variety of psychiatric disorders, and are difficult to treat. While there is meta-analytic evidence for the significant effect of non-invasive brain stimulation on drug and food craving, no study has investigated the potential of this technique to modulate sexual behavior.
AIM
Here, we tested the hypothesis that a single session of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) would reduce sexual arousal.
METHODS
We employed a randomized, double-blind, sham-controlled crossover study design. 19 healthy male participants received high-frequency rTMS over the left DLPFC, high-frequency rTMS over the right DLPFC, and sham rTMS (each 10 Hz; 110% resting motor threshold; 60 trains with 50 pulses) in randomized and counterbalanced order with a 1-week interval between stimulation sessions to avoid carryover effects. Participants were exposed to neutral and sexual cues before and after each intervention and rated their sexual arousal after each block of cue presentation.
MAIN OUTCOME MEASURE
Efficacy of the respective intervention was operationalized by the change of subjective sexual arousal according to a rating scale.
RESULTS
rTMS of the right DLPFC significantly reduced subjective sexual arousal (t 18 = 2.282, P = .035). In contrast, neither sham rTMS nor rTMS of the left DLPFC affected sexual arousal (P > .389). Greater rTMS-induced reduction of subjective sexual arousal was observed in participants with higher trait-based dyadic sexual desire within the last 12 months (r = -0.417, P = .038).
CLINICAL IMPLICATION
Non-invasive brain stimulation might hold potential for influencing hypersexual behavior.
STRENGTH & LIMITATION
This was a randomized, double-blind, sham-controlled crossover study with subjective but no physiological measures of sexual arousal.
CONCLUSION
The results indicate that 1 session of high-frequency rTMS (10 Hz) of the right DLPFC could significantly reduce subjective sexual arousal induced by visual stimuli in healthy subjects. On this basis, future studies with larger sample sizes and more stimulation sessions are needed to explore the therapeutic potential of rTMS in hypersexual behavior. Schecklmann M, Sakreida K, Oblinger B, et al. Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal: A Roof of Concept Study. J Sex Med 2020;17:1553-1559.",2020,"Greater rTMS-induced reduction of subjective sexual arousal was observed in participants with higher trait-based dyadic sexual desire within the last 12 months (r = -0.417, P = .038).
","['19 healthy male participants received', 'healthy subjects']","['high-frequency repetitive transcranial magnetic stimulation (rTMS', 'high-frequency rTMS over the left DLPFC, high-frequency rTMS over the right DLPFC, and sham rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['Schecklmann M, Sakreida K, Oblinger B, et', 'subjective sexual arousal', 'Sexual Arousal', 'sexual arousal', 'dyadic sexual desire']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation'}, {'cui': 'C0023618', 'cui_str': 'Libido'}]",19.0,0.181717,"Greater rTMS-induced reduction of subjective sexual arousal was observed in participants with higher trait-based dyadic sexual desire within the last 12 months (r = -0.417, P = .038).
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Sakreida', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Oblinger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Timm B', 'Initials': 'TB', 'LastName': 'Poeppl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Faculty of Medicine, RWTH Aachen University, Aachen, Germany. Electronic address: timm.poeppl@rwth-aachen.de.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.05.002']
1052,32450497,Effect of brexpiprazole on control of impulsivity in schizophrenia: A randomized functional magnetic resonance imaging study.,"Impulsivity in schizophrenia is a risk factor for suicide, drug abuse, and other risk-taking behaviors. This exploratory, multicenter, randomized, double-blind, functional magnetic resonance imaging (fMRI) study assessed the effects of brexpiprazole on brain regions that control impulsive behavior. Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms were randomized to 6 weeks of brexpiprazole 2 or 4 mg/day. The prespecified outcome measure was blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task. Secondary objectives evaluated the efficacy, safety and tolerability of brexpiprazole. Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task. Brexpiprazole was also associated with significantly improved stop-signal reaction time (SSRT). No worsening of psychiatric symptoms, functioning, or impulsivity occurred in these patients. No unexpected safety or tolerability concerns were identified. In conclusion, brexpiprazole treatment among patients with schizophrenia and impulsivity was associated with decreased right VLPFC activation and decreased SSRT, supportive of a benefit of brexpiprazole on inhibition-related brain activation and behavior. ClinicalTrials.gov identifier: NCT02194933.",2020,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","['Thirty-eight outpatients with stable schizophrenia and impulsivity symptoms', 'schizophrenia', 'patients with schizophrenia and impulsivity']","['brexpiprazole', 'functional magnetic resonance imaging (fMRI', 'Brexpiprazole']","['blood oxygen-level dependent (BOLD) activation in the right ventrolateral prefrontal cortex (VLPFC) during performance of tasks associated with inhibition/control of impulsivity: the go/no-go task and stop-signal task', 'right VLPFC BOLD activation', 'safety or tolerability concerns', 'right VLPFC activation', 'psychiatric symptoms, functioning, or impulsivity', 'efficacy, safety and tolerability of brexpiprazole', 'stop-signal reaction time (SSRT']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3885614', 'cui_str': 'brexpiprazole'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",38.0,0.07473,"Over 6 weeks, patients receiving brexpiprazole had no statistically significant change in right VLPFC BOLD activation during the go/no-go task, but showed a significant decrease in right VLPFC BOLD activation during the stop-signal task.","[{'ForeName': 'Theo Gm', 'Initials': 'TG', 'LastName': 'van Erp', 'Affiliation': 'Clinical and Translational Neuroscience Laboratory, University of California-Irvine, Irvine, CA, United States; Center for the Neurobiology of Learning and Memory, University of California-Irvine, Irvine, CA, United States. Electronic address: tvanerp@uci.edu.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Baker', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Cox', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, United States.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Okame', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Yoshitsugu', 'Initials': 'Y', 'LastName': 'Kojima', 'Affiliation': 'Otsuka Pharmaceutical Co. Ltd., Kanda Tsukasa-machi, Chiyoda-ku, Tokyo101-8535, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eramo', 'Affiliation': 'Lundbeck LLC, Deerfield, IL, United States.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Potkin', 'Affiliation': 'University of California-Irvine, Irvine, CA, United States; Tibor Rubin Veterans Affairs Medical Center, Long Beach, CA, United States. Electronic address: sgpotkin@gmail.com.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111085']
1053,32452352,Clinically meaningful improvement in work productivity loss in active psoriatic arthritis: post-hoc analysis of SPIRIT-P1 and SPIRIT-P2 trials.,"OBJECTIVES
To determine the proportion of patients in Phase 3 studies (SPIRIT-P1 and SPIRIT-P2) who achieved minimal clinically important difference (MCID) for work productivity loss and activity impairment domains of Work Productivity and Activity Impairment Specific Health Problem (WPAI-SHP) questionnaire.
METHODS
In the SPIRIT-P1 study, comprising a 24-week double-blind treatment period, biologic-naive patients with active psoriatic arthritis (PsA) were randomised to ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W) (starting dose of 160 mg), adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo. SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients who were randomised to receive IXEQ4W, IXEQ2W or placebo for 24 weeks of double-blind treatment. In this post-hoc analysis, we investigated the proportion of patients in SPIRIT-P1 and P2 studies who achieved 15% improvement in work productivity loss and 20% improvement in activity impairment domains of WPAI-SHP during double- blind treatment period.
RESULTS
In SPIRIT-P1, at Week 24, 57.1% and 55.8% of biologic-naive patients on IXEQ4W and ADAQ2W respectively, achieved MCID estimates for work productivity loss compared to 25.6% of patients treated with placebo. The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24. In SPIRIT-P2, significantly more TNFi-experienced patients on IXEQ4W (p<0.001) achieved MCIDs compared to placebo at Week 24.
CONCLUSIONS
Treatment with ixekizumab was associated with clinically meaningful improvements in WPAI-SHP domains in biologic-naive and TNFi- experienced patients with active PsA.",2020,The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24.,"['naive patients with active psoriatic arthritis (PsA', 'patients with active PsA', 'active psoriatic arthritis', 'SPIRIT-P2 enrolled tumour necrosis factor inhibitor (TNFi)-experienced patients']","['placebo', 'ixekizumab 80 mg every 4 weeks ', 'IXEQ4W, IXEQ2W or placebo', 'ixekizumab', 'adalimumab 40 mg every 2 weeks (ADAQ2W), or placebo', 'biologic', 'IXEQ4W) or every 2 weeks (IXEQ2W']","['activity impairment domains of WPAI-SHP', 'activity impairment', 'MCID estimates for work productivity loss', 'work productivity loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.398156,The proportion of ixekizumab- and adalimumab-treated patients achieving MCIDs for activity impairment were significantly higher (IXEQ4W: p<0.001; ADAQ2W: p=0.001) com- pared to placebo-treated patients at Week 24.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Department of Rheumatology, Royal National Hospital for Rheumatic Diseases, Bath, and Department of Pharmacy and Pharmacology, University of Bath, UK. w.tillett@nhs.net.'}, {'ForeName': 'Chen-Yen', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Trevelin Sprabery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Birt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California, San Diego (UCSD) School of Medicine, Division of Rheumatology, Allergy, and Immunology, San Diego, CA, USA.'}]",Clinical and experimental rheumatology,[]
1054,32463279,The effects of inhaled flavors on intravenous nicotine.,"Menthol is the only available flavor in combusted tobacco cigarettes; however, e-cigarettes are available in thousands of flavors. Research on flavors and rewarding properties of nicotine is limited. The present study sought to examine the acute rewarding effects of flavors inhaled from an e-cigarette, in combination with intravenous (IV) nicotine among cigarette smokers. In the present study, 24 menthol-preferring young adult (aged 18 to 30) cigarette smokers were tested under 3 different e-cigarette flavor conditions (menthol, green apple, or menthol + green apple) in a within-subject cross-over design. During each test session, each participant received 3 IV infusions (saline, 0.25 mg/70 kg nicotine, 0.5 mg/70 kg nicotine) administered 1 hr apart. The main outcome measures assessed cardiovascular, subjective, and cognitive domains. Compared with green apple or green apple + menthol, menthol produced higher ratings of ""cooling"" ( p s < 0.01). Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05). As expected, IV-nicotine dose-dependently increased the ratings of subjective liking/disliking and peak heart rate, improved cognitive performance, and reduced smoking urges (all p s < 0.05). These subjective, cognitive, and physiological effects of nicotine were not affected by any flavor condition. The present findings did not support an interaction between IV-nicotine dose and inhaled flavor for acute effects of nicotine. Green apple flavor, alone or in combination with menthol, could result in higher craving or insufficiently alleviate craving, relative to menthol flavor alone. Additional research is warranted to examine extended exposure to inhaled flavors on the rewarding and addictive effects of nicotine. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05).,"['cigarette smokers', '24 menthol-preferring young adult (aged 18 to 30) cigarette smokers']","['IV infusions (saline, 0.25 mg/70 kg nicotine, 0.5 mg/70 kg nicotine', 'Green apple flavor, alone or in combination with menthol', 'cigarette flavor conditions (menthol, green apple, or menthol + green apple', 'Menthol', 'inhaled flavors', 'nicotine', 'flavors inhaled from an e-cigarette, in combination with intravenous (IV) nicotine', 'green apple or green apple + menthol, menthol']","['cardiovascular, subjective, and cognitive domains', 'ratings of subjective liking/disliking and peak heart rate, improved cognitive performance, and reduced smoking urges', 'Craving', 'ratings of ""cooling']","[{'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0475653', 'cui_str': 'Apple flavor'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",,0.0245257,Craving was rated higher following administration of green apple and the combined menthol + apple flavor compared to menthol alone ( p s < 0.05).,"[{'ForeName': 'R Ross', 'Initials': 'RR', 'LastName': 'MacLean', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'Elise E', 'Initials': 'EE', 'LastName': 'DeVito', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'MacKenzie R', 'Initials': 'MR', 'LastName': 'Peltier', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Suprit', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'VA Connecticut Healthcare System.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sofuoglu', 'Affiliation': 'VA Connecticut Healthcare System.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000394']
1055,32455501,Characteristics of three different patellar implant designs in total knee arthroplasty.,"BACKGROUND
Despite debate over the role of patellar resurfacing in total knee arthroplasty, many surgeons feel it decreases re-operation rates and anterior pain, and an increasing number are adopting resurfacing. This study compares intra-operative characteristics of different patellar implants to assist surgeons in gaining better understanding of these implants.
METHODS
The three most commonly used patellar implants (inset, onlay round and onlay oval) were allocated randomly to 120 patients undergoing total knee arthroplasty. We compared the groups in terms of implant size, bone coverage, lateral underhang (uncovered lateral facet) and need for partial lateral facetectomy. We also compared the patient-reported outcome measures between the groups at 6 months post-operatively.
RESULTS
The inset, onlay round and onlay oval designs had bone coverage of 48.5%, 65.9% and 85.9%, respectively (P < 0.01). Similarly, the onlay-oval implant was found to have the smallest lateral underhang of all three designs (inset 11.6 mm; onlay round 6.9 mm, onlay oval 1.6 mm, P < 0.01). The onlay-oval design was the largest implant with a median size of 35 mm, compared to 23 mm for the inset and 32 mm for the onlay round (P < 0.01). In addition, patellae using onlay-oval implants required significantly fewer lateral facetectomies due to improved bone coverage (inset 95%; onlay round 87%; onlay oval 3%; P < 0.01). Finally, comparison of patient-reported outcome measures between the groups showed no difference at an early assessment of 6 months.
CONCLUSION
Onlay-oval design allows for the use of a larger implant, improving bone coverage and reducing the need for partial lateral facetectomy; however, early assessment of outcomes shows no difference between the three designs.",2020,"The onlay-oval design was the largest implant with a median size of 35 mm, compared to 23 mm for the inset and 32 mm for the onlay round (P < 0.01).","['total knee arthroplasty', '120 patients undergoing total knee arthroplasty']",['patellar resurfacing'],"['bone coverage', 'lateral facetectomies']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0546528', 'cui_str': 'Facetectomy'}]",120.0,0.0658765,"The onlay-oval design was the largest implant with a median size of 35 mm, compared to 23 mm for the inset and 32 mm for the onlay round (P < 0.01).","[{'ForeName': 'Monther A', 'Initials': 'MA', 'LastName': 'Gharaibeh', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Darren B', 'Initials': 'DB', 'LastName': 'Chen', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jil A', 'Initials': 'JA', 'LastName': 'Wood', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'MacDessi', 'Affiliation': 'Sydney Knee Specialists, St George Private Hospital, Sydney, New South Wales, Australia.'}]",ANZ journal of surgery,['10.1111/ans.15988']
1056,31562908,Sex Differences in Transfemoral Transcatheter Aortic Valve Replacement.,"BACKGROUND
Transfemoral aortic valve replacement (TAVR) is a guideline-recommended treatment option for patients with severe aortic valve stenosis. Women and men present with different baseline characteristics, which may influence procedural outcomes.
OBJECTIVES
This study sought to evaluate differences between women and men undergoing transfemoral TAVR across the globe during the last decade.
METHODS
The CENTER (Cerebrovascular EveNts in patients undergoing TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration was a global patient level dataset of patients undergoing transfemoral TAVR (N = 12,381) from 2007 to 2018. In this retrospective analysis, the study examined differences in baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes between female and male patients. The study also assessed for temporal changes in outcomes and predictors for mortality per sex.
RESULTS
We included 58% (n = 7,120) female and 42% (n = 5,261) male patients. Women had higher prevalence of hypertension and glomerular filtration rate <30 ml/min/1.73 m 2 but lower prevalence of all other traditional cardiovascular comorbidities. Both sexes had similar rates of 30-day stroke (2.3% vs. 2.5%; p = 0.53) and mortality (5.9% vs. 5.5%; p = 0.17). In contrast, women had a 50% higher risk of life-threatening or major bleeding (6.7% vs. 4.4%; p < 0.01). Over the study period, mortality rates decreased to a greater extent in men than in women (60% vs. 50% reduction; both p < 0.001), with no reductions in stroke rates over time.
CONCLUSIONS
In this global collaboration, women and men had similar rates of 30-day mortality and stroke. However, women had higher rates of procedural life-threatening or major bleeding after TAVR. Between 2007 and 2018, mortality rates decreased to a greater extent in men than in women.",2019,Women had higher prevalence of hypertension and glomerular filtration rate ,"['female and male patients', 'women and men undergoing transfemoral TAVR across the globe during the last decade', 'n\xa0=\xa05,261) male patients', 'patients undergoing', 'patients with severe aortic valve stenosis', 'We included 58% (n\xa0=\xa07,120) female and 42% ']","['Transfemoral Transcatheter Aortic Valve Replacement', 'Transfemoral aortic valve replacement (TAVR', 'TranscathetER aortic valve implantation with balloon-expandable valves versus self-expandable valves)-collaboration']","['mortality rates', 'procedural life-threatening or major bleeding', 'hypertension and glomerular filtration rate', 'risk of life-threatening or major bleeding', 'mortality', '30-day stroke', 'stroke rates', 'baseline patient characteristics, 30-day stroke and mortality, and in-hospital outcomes', '30-day mortality and stroke']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",5261.0,0.160583,Women had higher prevalence of hypertension and glomerular filtration rate ,"[{'ForeName': 'Wieneke', 'Initials': 'W', 'LastName': 'Vlastra', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandrasekhar', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'García Del Blanco', 'Affiliation': ""Department of Cardiology, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchétché', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'de Brito', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Barbanti', 'Affiliation': 'Division of Cardiology, Policlinico-Vittorio Emanuele Hospital, University of Catania, Catania, Italy.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Azeem', 'Initials': 'A', 'LastName': 'Latib', 'Affiliation': 'Division of Cardiology, Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': ""D'Onofrio"", 'Affiliation': 'Division of Cardiac Surgery, University of Padova, Padua, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Ribichini', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Baan', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'University Hospital La Paz, Madrid, Spain; Instituto de Investigación Hospital La Paz (IDIPAZ), Madrid, Spain; Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Tarasoutchi', 'Affiliation': 'Heart Institute, University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Sartori', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': ""D'Errigo"", 'Affiliation': 'National Centre for Global Health, Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': 'Division of Cardiac Surgery, University of Padova, Padua, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Lunardi', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Orvin', 'Affiliation': 'Cardiology Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pagnesi', 'Affiliation': 'Division of Cardiology, Montefiore Medical Center, New York, New York.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Berenguer', 'Affiliation': 'Cardiology Department, Hospital General de Valencia, Valencia, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Modine', 'Affiliation': 'Centre Hospitalier Universitaire, Lille, France.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, the Netherlands. Electronic address: r.delewi@amsterdamumc.nl.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.09.015']
1057,32453647,Ultra-Rapid Lispro Improves Postprandial Glucose Control and Time in Range in Type 1 Diabetes Compared to Lispro: PRONTO-T1D Continuous Glucose Monitoring Substudy.,"Background: This study evaluated glucose control by continuous glucose monitoring (CGM) during treatment with ultra-rapid lispro (URLi) or lispro used in combination with insulin glargine or degludec in adults with type 1 diabetes in a substudy of the PRONTO-T1D study. Methods: Ambulatory glucose profiles were evaluated in 269 patients from PRONTO-T1D assigned to double-blind URLi ( n = 97) or lispro ( n = 99) given 0-2 min before the start of the meal (mealtime), or open-label URLi ( n = 73) given 20 min after the meal (postmeal URLi). Blinded CGM was used for up to 14 days before baseline and the 26-week primary endpoint. The primary objective was to compare mealtime URLi and lispro with respect to incremental area under the serum glucose concentration versus time curve from 0 to 2 h (iAUC 0-2h ) after breakfast. Results: Mealtime URLi was superior in reducing the iAUC 0-2h when compared to lispro for breakfast (least squares mean [LSM] difference -28.1 mg·h/L, P = 0.048) and for all meals combined. iAUC 0-3h and iAUC 0-4h were also reduced. Postmeal URLi resulted in similar postprandial glucose (PPG) control to mealtime lispro, but less optimal PPG control compared to mealtime URLi. Mealtime URLi increased daytime time in range (71-180 mg/dL [3.9-10.0 mmo/L]) (LSM difference = +43.6 min, P = 0.020) and decreased nighttime time in hypoglycemia (LSM difference ≤70 mg/dL [3.9 mmol/L] = -11.5 min, P = 0.009) compared to mealtime lispro. Conclusions: Results of this CGM substudy support the improved PPG control seen with mealtime URLi in the PRONTO-T1D study and show that mealtime URLi resulted in improved daytime time in target range.",2020,Mealtime URLi was superior in reducing the iAUC0-2hrs when compared to lispro for breakfast (least squares mean difference,"['Type 1 Diabetes', '269 patients from PRONTO-T1D assigned to', 'adults with type 1 diabetes in a sub-study of the PRONTO-T1D study']","['continuous glucose monitoring (CGM', 'ultra rapid lispro (URLi) or lispro used in combination with insulin glargine', 'CGM', 'LSM-diff', 'double-blind URLi', 'lispro (n=99) given 0-2 minutes before the start of the meal (mealtime), or open-label URLi', 'Ultra Rapid Lispro', 'dL', 'Lispro']","['mealtime URLi and lispro with respect to incremental area under the glucose concentration versus time curve', 'daytime time', 'nighttime time in hypoglycemia (LSM-diff ≤70']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1260720', 'cui_str': 'Pronto'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",269.0,0.0350752,Mealtime URLi was superior in reducing the iAUC0-2hrs when compared to lispro for breakfast (least squares mean difference,"[{'ForeName': 'Maciej T', 'Initials': 'MT', 'LastName': 'Malecki', 'Affiliation': 'Department of Metabolic Diseases, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Dachuang', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hardy', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Bode', 'Affiliation': 'Endocrinologist and Partner, Atlanta Diabetes Associates, Atlanta, Georgia, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Bergenstal', 'Affiliation': 'Endocrinologist and Executive Director, International Diabetes Center, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'DC and RL Clinical Design, Delivery, and Analytics, TH and JB-V Connected Care and Insulins-Medical Development, Eli Lilly and Company, Indianapolis, Indiana, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0129']
1058,32460465,Effects of hypercarbia on arterial oxygenation during one-lung ventilation: prospective randomized crossover study.,"Background
This study aimed to evaluate the effects of hypercarbia on arterial oxygenation during one-lung ventilation (OLV).
Methods
Fifty adult patients undergoing elective video-assisted thoracoscopic lobectomy or pneumonectomy were enrolled. Group I patients (n = 25) were first maintained at normocarbia (PaCO2: 38‒42 mmHg) for 30 min and then at hypercarbia (45‒50 mmHg). In Group II patients (n = 25), PaCO2 was maintained in the reverse order. Arterial oxygen partial pressure (PaO2), respiratory variables, hemodynamic variables, and hemoglobin concentration were compared during normocarbia and hypercarbia. Arterial O2 content and O2 delivery were calculated.
Results
PaO2 values during normocarbia and hypercarbia were 66.5 ± 10.6 and 79.7 ± 17.3 mmHg, respectively (mean difference: 13.2 mmHg, 95% CI for difference of means: 17.0 to 9.3, P < 0.001). SaO2 values during normocarbia and hypercarbia were 92.5 ± 4.8% and 94.3 ± 3.1% (P = 0.009), respectively. Static compliance of the lung (33.0 ± 5.4 vs. 30.4 ± 5.3 ml/cmH2O, P < 0.001), arterial O2 content (15.4 ± 1.4 vs. 14.9 ± 1.5 ml/dl, P < 0.001) and O2 delivery (69.9 ± 18.4 vs. 65.1 ± 18.1 ml/min, P < 0.001) were significantly higher during hypercarbia than during normocarbia.
Conclusions
Hypercarbia increases PaO2 and O2 carrying capacity and improves pulmonary mechanics during OLV, suggesting that it may help manage oxygenation during OLV. Therefore, permissive hypercarbia may be a simple and valuable modality to manage arterial oxygenation during OLV.",2020,"Static compliance of the lung (33.0 ± 5.4 vs. 30.4 ± 5.3 mL/cmH 2 O, P < 0.001), arterial O 2 content (15.4 ± 1.4 vs. 14.9 ± 1.5 mL/dL, P < 0.001) and O 2 delivery (69.9 ± 18.4 vs. 65.1 ± 18.1 mL/min, P <0.001) were significantly higher during hypercarbia than during normocarbia.
","['one-lung ventilation', 'Fifty adult patients undergoing']","['hypercarbia', 'elective video-assisted thoracoscopic lobectomy or pneumonectomy']","['Static compliance of the lung', 'arterial oxygenation', 'Arterial oxygen partial pressure (PaO 2 ), respiratory variables, hemodynamic variables, and hemoglobin concentration', 'Arterial O 2 content and O 2 delivery']","[{'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0032284', 'cui_str': 'Pneumonectomy'}]","[{'cui': 'C0429681', 'cui_str': 'Static lung compliance'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",25.0,0.0579572,"Static compliance of the lung (33.0 ± 5.4 vs. 30.4 ± 5.3 mL/cmH 2 O, P < 0.001), arterial O 2 content (15.4 ± 1.4 vs. 14.9 ± 1.5 mL/dL, P < 0.001) and O 2 delivery (69.9 ± 18.4 vs. 65.1 ± 18.1 mL/min, P <0.001) were significantly higher during hypercarbia than during normocarbia.
","[{'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School and Hospital, Jeonju, Korea.'}, {'ForeName': 'Yesull', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School and Hospital, Jeonju, Korea.'}, {'ForeName': 'Juhan', 'Initials': 'J', 'LastName': 'Mun', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School and Hospital, Jeonju, Korea.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School and Hospital, Jeonju, Korea.'}, {'ForeName': 'Seonghoon', 'Initials': 'S', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School and Hospital, Jeonju, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.19445']
1059,32468396,Anxiety and Depression Reduction as Distal Outcomes of a College Transition Readiness Program for Adults with Autism.,"Young adults with autism spectrum disorder (ASD) experience increased rates of anxiety and depression which can impact academic success. The Stepped Transition in Education Program for Students with ASD (STEPS) applies cognitive-behavioral principles to help young adults with ASD improve their adjustment to postsecondary education. We aimed to determine if STEPS had an effect on anxiety and depression. Treatment-seeking adults with ASD (n = 32; Mage = 19.74) were randomized to STEPS or transition as usual (TAU; i.e., waitlist control group). STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist. Anxiety symptoms did not significantly change. Results suggest that transition support for young people with ASD may improve mental health.",2020,STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist.,"['Students with ASD (STEPS) applies cognitive-behavioral principles to help young adults with ASD', 'Treatment-seeking adults with ASD (n\u2009=\u200932; Mage\u2009=\u200919.74', 'Young adults with autism spectrum disorder', 'Adults with Autism', 'young people with ASD']","['STEPS', 'College Transition Readiness Program']","['Anxiety symptoms', 'Anxiety and Depression Reduction', 'mental health', 'rates of anxiety and depression', 'anxiety and depression', 'depressive symptoms']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0373388,STEPS participants evinced significantly greater declines in depressive symptoms from pre-treatment to post-treatment compared to the waitlist.,"[{'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Capriola-Hall', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA. nncapriola@crimson.ua.edu.'}, {'ForeName': 'Alexis M', 'Initials': 'AM', 'LastName': 'Brewe', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Golt', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'White', 'Affiliation': 'Center for Youth Development and Intervention, The University of Alabama, Box 870348, Tuscaloosa, AL, 35487-0348, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04549-6']
1060,32468447,Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog ® (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial.,"BACKGROUND
Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the pharmacokinetics, glucodynamics, safety, and tolerability of URLi and Humalog ® in patients with type 1 diabetes mellitus (T1DM).
METHODS
This was a phase I, two-period, randomised, double-blind, crossover glucose clamp study in younger adult (aged 18-45 years; n = 41) and elderly (aged ≥65 years; n = 39) patients with T1DM. At each dosing visit, patients received either URLi or Humalog (15 units subcutaneously) followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured.
RESULTS
Insulin lispro appeared in serum 6 min faster, and exposure was 7.2-fold greater over the first 15 min postdose with URLi versus Humalog in both age groups. Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups. Onset of insulin action was 11-12 min faster, and insulin action was 3-fold greater over the first 30 min postdose with URLi versus Humalog in both age groups. Insulin action beyond 4 h postdose was 44-54% lower, and duration of action was reduced by 34-44 min with URLi versus Humalog in both age groups. Overall exposure and total insulin action remained similar for both treatments. URLi and Humalog were well tolerated.
CONCLUSION
In patients with T1DM, URLi showed ultra-rapid pharmacokinetics and glucodynamics, with the differences between URLi and Humalog in elderly patients mirroring those in younger adults. ClinicalTrials.gov identifier: NCT03166124.",2020,"Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups.","['patients with T1DM', 'Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus', 'younger adult (aged 18-45\xa0years; n\xa0=\xa041) and elderly (aged ≥65\xa0years; n\xa0=\xa039', 'elderly patients mirroring those in younger adults', 'patients with type 1 diabetes mellitus (T1DM']","['URLi or Humalog (15 units subcutaneously) followed by a 10\xa0h automated euglycaemic clamp procedure', 'URLi and Humalog ®', 'Ultra\xa0Rapid Lispro (URLi) versus Humalog ® (Lispro', 'Ultra\xa0rapid lispro (URLi']","['ultra-rapid pharmacokinetics and glucodynamics', 'insulin action', 'tolerated', 'exposure duration', 'Serum insulin lispro and blood glucose', 'duration of action', 'Onset of insulin action', 'serum 6\xa0min faster, and exposure', 'Overall exposure and total insulin action', 'Insulin action', 'pharmacokinetics, glucodynamics, safety, and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",39.0,0.0923738,"Exposure beyond 3 h postdose was 39-41% lower, and exposure duration was reduced by 72-74 min with URLi versus Humalog in both age groups.","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA. linnebjerg_helle@lilly.com.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Herbrand', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, 46285, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00903-0']
1061,32456999,Patient Perception of Medical Student Professionalism: Does Attire Matter?,"INTRODUCTION
Patient compliance and outcomes have been shown to be influenced by the quality of the doctor-patient relationship. In addition, the effect of physician attire on the patient's perception of the physician has been long appreciated. Data shows that professional attire is preferred by patients. Whereas treating physicians are the backbone of patient management, medical students are often a patient's first encounter in a teaching clinic. Patient perception of the student may impact their rating of the attending physician. Despite this, medical students are often dressed wearing scrubs in surgery clinic. The purpose of this study was to determine if patient perception of medical students would be affected by the students' attire.
METHODS
A 7-item, validated professionalism scale was used to survey surgery clinic patients whose initial examinations were performed by a medical student. Students were blinded and randomly assigned to wear professional attire versus scrubs. Patients' responses of 'strongly agree' were compared to lower ratings for each item.
RESULTS
One hundred twenty-three patients completed our survey, 63 (51.2%) wearing scrubs and 60 (48.8%) in professional attire. The average age was 49.7 ± 15.8 years. In the professional attire group, there was no significant association for any of the 7 items. However, in the scrubs group, all 7 items were significant such that a higher proportion of patients under the age of 60 rated medical students wearing scrubs higher than did patients aged 60 and above.
CONCLUSION
Students in scrubs were perceived to be less knowledgeable, competent, and professional by older patients. In contrast, younger patients seemed unaffected by the dress of medical students in clinic. Older patients may judge the medical community's growing acceptance of more casual attire in the workplace as less professional, potentially affecting patient satisfaction. Surgical educators should require a standard of professional attire for students in clinic.",2020,"In the professional attire group, there was no significant association for any of the 7 items.","['Older patients', 'Students in scrubs were perceived to be less knowledgeable, competent, and professional by older patients', 'One hundred twenty-three patients completed our survey, 63 (51.2%) wearing scrubs and 60 (48.8%) in professional attire', 'patient perception of medical students', 'The average age was 49.7 ± 15.8 years']",['professional attire versus scrubs'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2946035', 'cui_str': 'Scrubs'}]",[],123.0,0.0153431,"In the professional attire group, there was no significant association for any of the 7 items.","[{'ForeName': 'Aabra', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Sharjeel', 'Initials': 'S', 'LastName': 'Israr', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona. Electronic address: Sharjeel.Israr@dignityhealth.org.""}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Chapple', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Weinberg', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Goslar', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Hayden', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Ronald A', 'Initials': 'RA', 'LastName': 'Gagliano', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Gillespie', 'Affiliation': ""Creighton University School of Medicine, Phoenix Campus, St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}]",Journal of surgical education,['10.1016/j.jsurg.2020.04.016']
1062,31806881,"OPRM1, OPRK1, and COMT genetic polymorphisms associated with opioid effects on experimental pain: a randomized, double-blind, placebo-controlled study.","Genetic polymorphisms have been shown to affect opioid requirement for pain relief. However, true genetic effect is often difficult to assess due to underlying pain conditions and placebo effects. The goal of this study was to understand how common polymorphisms affect opioid effects while controlling for these factors. A randomized, double-blind, placebo-controlled study was implemented to assess how opioid effects are modulated by COMT (rs6269, rs4633, rs4848, rs4680), OPRM1 (A118G), and OPRK1 (rs1051660, rs702764, rs16918875). One hundred and eight healthy subjects underwent experimental pain testing before and after morphine, butorphanol, and placebo (saline). Association analysis was performed between polymorphisms/haplotypes and opioid response, while correcting for race, gender, placebo effects, and multiple comparisons. Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol. The AA genotype of rs4680 or A_T_C_A/ A_T_C_A (rs6269_rs4633_ rs4818_rs4680) diplotype of COMT, combined with the AG genotype of OPRM1 A118G, showed significantly increased pressure pain threshold from butorphanol. Opioid effects on pressure, ischemic, heat pain, and side effects were nominally associated with several SNPs and haplotypes. Effects were often present in one opioid but not the other. This indicates that these polymorphisms affect pain relief from opioids, and that their effects are opioid and pain modality specific.",2020,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,['One hundred and eight healthy subjects'],"['butorphanol', 'morphine, butorphanol, and placebo (saline', 'placebo']","['Pressure pain', 'pressure, ischemic, heat pain, and side effects', 'pressure pain', 'experimental pain']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",108.0,0.58088,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,"[{'ForeName': 'Kwo Wei David', 'Initials': 'KWD', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University, Redwood City, CA, USA. kwoweiho@stanford.edu.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Wallace', 'Affiliation': 'Department of Molecular Genetics & Microbiology, and UF Genetics Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville, FL, USA.'}]",The pharmacogenomics journal,['10.1038/s41397-019-0131-z']
1063,32468448,"Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog ® (Lispro) in Patients with Type 2 Diabetes Mellitus: A Phase I Randomised, Crossover Study.","BACKGROUND AND OBJECTIVE
Ultra rapid lispro (URLi) is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This study compared the insulin lispro pharmacokinetics and glucodynamics, safety and tolerability of URLi and Humalog ® after a single subcutaneous dose in patients with type 2 diabetes mellitus (T2DM).
METHODS
This was a phase I, randomised, two-period, two-treatment, double-blind, crossover study in 38 patients with T2DM. At each dosing visit, patients received either 15 units of URLi or Humalog, followed by a 10 h automated euglycaemic clamp procedure. Serum insulin lispro and blood glucose were measured.
RESULTS
Insulin lispro appeared in the serum 5 min faster (p < 0.0001) and exposure was 6.4-fold greater in the first 15 min (p < 0.0001) with URLi versus Humalog. Exposure beyond 3 h postdose was 26% lower and the duration of exposure was 51 min shorter with URLi versus Humalog. Onset of insulin action was 13 min faster (p < 0.0001) and insulin action was 4.2-fold greater within the first 30 min (p < 0.0001) with URLi versus Humalog. Insulin action beyond 4 h postdose was 20% lower (p = 0.0099) with URLi versus Humalog. Overall insulin lispro exposure and total glucose infused were similar for URLi and Humalog. Both treatments were well tolerated.
CONCLUSIONS
This is the first study to investigate URLi in patients with T2DM using a euglycaemic clamp procedure. URLi demonstrated ultra-rapid pharmacokinetics and glucodynamics in patients with T2DM. CLINICALTRIALS.
GOV IDENTIFIER
NCT03305822.",2020,Onset of insulin action was 13 min faster (p < 0.0001) and insulin action was 4.2-fold greater within the first 30 min (p < 0.0001) with URLi versus Humalog.,"['patients with T2DM using a euglycaemic clamp procedure', 'Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM', '38 patients with T2DM']","['15 units of URLi or Humalog, followed by a 10\xa0h automated euglycaemic clamp procedure', 'URLi and Humalog ®', 'URLi', 'Ultra Rapid Lispro (URLi) versus Humalog ® (Lispro']","['Overall insulin lispro exposure and total glucose', 'insulin lispro pharmacokinetics and glucodynamics, safety and tolerability', 'insulin action', 'duration of exposure', 'Serum insulin lispro and blood glucose', 'tolerated', 'Onset of insulin action', 'Insulin lispro', 'Insulin action beyond 4\xa0h postdose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",38.0,0.0565095,Onset of insulin action was 13 min faster (p < 0.0001) and insulin action was 4.2-fold greater within the first 30 min (p < 0.0001) with URLi versus Humalog.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Leohr', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA. leohr_jennifer_k@lilly.com.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Coutant', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'LaBell', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Heise', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Grit', 'Initials': 'G', 'LastName': 'Andersen', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Hermanski', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Leszek', 'Initials': 'L', 'LastName': 'Nosek', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Linnebjerg', 'Affiliation': 'Eli Lilly and Company, Lilly Research Laboratories DC 0730, Indianapolis, IN, 46285, USA.'}]",Clinical pharmacokinetics,['10.1007/s40262-020-00901-2']
1064,32459919,Remdesivir for 5 or 10 Days in Patients with Severe Covid-19.,"BACKGROUND
Remdesivir is an RNA polymerase inhibitor with potent antiviral activity in vitro and efficacy in animal models of coronavirus disease 2019 (Covid-19).
METHODS
We conducted a randomized, open-label, phase 3 trial involving hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia. Patients were randomly assigned in a 1:1 ratio to receive intravenous remdesivir for either 5 days or 10 days. All patients received 200 mg of remdesivir on day 1 and 100 mg once daily on subsequent days. The primary end point was clinical status on day 14, assessed on a 7-point ordinal scale.
RESULTS
In total, 397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days). The median duration of treatment was 5 days (interquartile range, 5 to 5) in the 5-day group and 9 days (interquartile range, 5 to 10) in the 10-day group. At baseline, patients randomly assigned to the 10-day group had significantly worse clinical status than those assigned to the 5-day group (P = 0.02). By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group. After adjustment for baseline clinical status, patients in the 10-day group had a distribution in clinical status at day 14 that was similar to that among patients in the 5-day group (P = 0.14). The most common adverse events were nausea (9% of patients), worsening respiratory failure (8%), elevated alanine aminotransferase level (7%), and constipation (7%).
CONCLUSIONS
In patients with severe Covid-19 not requiring mechanical ventilation, our trial did not show a significant difference between a 5-day course and a 10-day course of remdesivir. With no placebo control, however, the magnitude of benefit cannot be determined. (Funded by Gilead Sciences; GS-US-540-5773 ClinicalTrials.gov number, NCT04292899.).",2020,"By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group.","['patients with severe Covid-19 not requiring mechanical ventilation', 'hospitalized patients with confirmed SARS-CoV-2 infection, oxygen saturation of 94% or less while they were breathing ambient air, and radiologic evidence of pneumonia', 'Patients with Severe Covid-19', '397 patients underwent randomization and began treatment (200 patients for 5 days and 197 for 10 days']",['intravenous remdesivir'],"['worsening respiratory failure', 'ordinal scale', 'distribution in clinical status', 'clinical status on day 14, assessed on a 7-point ordinal scale', 'elevated alanine aminotransferase level', 'nausea', 'constipation', 'clinical status', 'median duration of treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",397.0,0.213119,"By day 14, a clinical improvement of 2 points or more on the ordinal scale occurred in 64% of patients in the 5-day group and in 54% in the 10-day group.","[{'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Goldman', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'David C B', 'Initials': 'DCB', 'LastName': 'Lye', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Hui', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Marks', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Montejano', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Mi-Young', 'Initials': 'MY', 'LastName': 'Ahn', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Nahass', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Yao-Shen', 'Initials': 'YS', 'LastName': 'Chen', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Anu O', 'Initials': 'AO', 'LastName': 'Osinusi', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Xuelian', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Towner', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Karen T', 'Initials': 'KT', 'LastName': 'Tashima', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Diaz', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Subramanian', 'Affiliation': ""From the Swedish Center for Research and Innovation, Swedish Medical Center, and the University of Washington, Seattle (J.D.G.), and Providence Regional Medical Center, Everett (G.D.) - both in Washington; the National Center for Infectious Diseases, Lee Kong Chian School of Medicine, Tan Tock Seng Hospital, Singapore (D.C.B.L.); the Chinese University of Hong Kong-Prince of Wales Hospital, Hong Kong (D.S.H.); New York-Presbyterian Hospital and Weill Cornell Medicine, New York (K.M. Marks); Malattie Infettive Fondazione IRCCS Policlinico San Matteo, Pavia-Università di Pavia, Pavia (R.B.), and Università di Milano, Department of Biomedical and Clinical Sciences, L. Sacco Infectious Diseases Unit, ASST Fatebenefratelli Sacco, Milan (M.G.) - both in Italy; Hospital Universitario La Paz, IdiPAZ, Madrid (R.M.), and Barcelona Institute for Global Health (ISGlobal) Hospital Clínic-Universitat de Barcelona, Barcelona (J.M.); Technical University of Munich, School of Medicine, University Hospital rechts der Isar, Munich, Germany (C.D.S.); Seoul Medical Center, Seoul, South Korea (M.-Y.A.); ID Care, Hillsborough, and Robert Wood Johnson University Hospital Somerset, Somerville - both in New Jersey (R.G.N.); Kaohsiung Veterans General Hospital, Taiwan (Y.-S.C.); Gilead Sciences, Foster City (D.S., R.H.H., A.O.O., H.C., C.B., X.W., A.G., D.M.B.), Kaiser Permanente, Los Angeles (W.J.T.), and Stanford University, Palo Alto (A.S.) - all in California; University of Chicago, Chicago (K.M. Mullane); Brigham and Women's Hospital and Harvard Medical School, Boston (F.M.M.); and Miriam Hospital, Warren Alpert Medical School of Brown University, Providence, RI (K.T.T.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2015301']
1065,32467415,A Telemedicine Approach to Increase Treatment of Alcohol Use Disorder in Primary Care: A Pilot Feasibility Study.,"BACKGROUND AND AIMS
Unhealthy drinking is a leading threat to health, yet few people with alcohol use disorder (AUD) receive treatment. This pilot tested the feasibility of addiction medicine video consultations in primary care for improving AUD medication adoption and specialty treatment initiation.
METHODS
Primary care providers (PCPs) received training and access to on-call addiction medicine consultations. Feasibility measures were training attendance, intention to use the service and/or AUD pharmacotherapy, and user feedback. Secondary outcomes were utilization, prescription and treatment initiation rates, and case reports. χ tests were used to compare prescription and treatment initiation rates for consult recipients and non-recipients.
RESULTS
Ninety-one PCPs (71.1%) attended a training, and 60 (65.9%) provided feedback. Of those, 37 (64.9%) mentioned pharmacotherapy and 41 (71.9%) intended to use the video consult service. Of 27 users, 19 provided feedback; 12 (63.1%) rated its value at 8 or above, on a scale of 1 to 10 (average 6.9). The most useful aspect was immediacy, and users wanted an easier workflow and increased consultant availability. Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
CONCLUSIONS
PCP training attendance and feedback suggest that an addiction telemedicine consult service would be valuable to PCPs and might increase AUD medication uptake and specialty addiction treatment initiation. However, future research should include significant modifications to the piloted telemedicine model: robust staffing and simpler, more flexible methods for PCPs to obtain consults.",2020,"Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
","['Alcohol Use Disorder in Primary Care', 'Primary care providers (PCPs) received']","['training and access to on-call addiction medicine consultations', 'naltrexone', 'addiction medicine video consultations']","['training attendance, intention to use the service and/or AUD pharmacotherapy, and user feedback', 'utilization, prescription and treatment initiation rates, and case reports']","[{'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C4505067', 'cui_str': 'Addiction Medicine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0007320', 'cui_str': 'Case Reports'}]",,0.0441061,"Of 32 patients who received a consult, 11 (34.4%) were prescribed naltrexone, versus 43 (6.4%) of non-recipients (P < 0.0001); 11 (34.4%) initiated specialty treatment, versus 105 (19.7%) of non-recipients (P < 0.05).
","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Leibowitz', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, 3rd Floor, Oakland, CA (AL, DDS, WL, CW, SS), Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Avenue, San Francisco, CA (DDS), The Permanente Medical Group, Addiction Medicine and Recovery Services, 380\u200aW MacArthur Blvd, Oakland, CA (CC), The Permanente Medical Group, East Bay Technology, 901 Nevin Avenue, Richmond, CA (EG).'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Weisner', 'Affiliation': ''}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Corriveau', 'Affiliation': ''}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Gizzi', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Sterling', 'Affiliation': ''}]",Journal of addiction medicine,['10.1097/ADM.0000000000000666']
1066,32469454,Changes in self-reported and observed parenting following a randomized control trial of parent-child interaction therapy for the treatment of preschool depression.,"BACKGROUND
Parenting in early childhood exerts substantial influence over children's emotional health and development. Using data from a randomized controlled trial of a novel treatment for early childhood depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED), we explored two broad dimensions of parenting (behavior and affect) to determine whether any changes could be detected following treatment when compared to those in a waitlist control condition.
METHOD
229 caregiver-child dyads, 114 randomly assigned to PCIT-ED for preschool-onset depression, and 115 assigned to a waitlist completed two structured interaction tasks at baseline and post-treatment. Interactions were later coded by observer's blind to diagnostic and treatment status.
RESULTS
Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group. Increases in the overall positivity of the observed interactional style of caregivers, but no observed parenting behavior change was found following treatment. Discrepancies between self-reported and observed parenting were greater among caregivers on the waitlist.
CONCLUSIONS
Following PCIT-ED treatment, caregivers self-reported improvements in parenting practices and declines in punitive practices along with observed increases in positive affect and decreases in negative affect when interacting with their child. Moreover, coherence between self-reported and observed parenting was higher in the treatment group. These findings highlight the efficacy of PCIT-ED in improving parenting behaviors and the need to use multiple methods to assess parenting in treatment studies.",2020,"RESULTS
Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group.","['early childhood depression, Parent-Child Interaction Therapy Emotion Development (PCIT-ED', 'preschool depression', '229 caregiver-child dyads, 114 randomly assigned to PCIT-ED for preschool-onset depression, and 115 assigned to a']","['waitlist completed two structured interaction tasks at baseline and post-treatment', 'PCIT-ED', 'parent-child interaction therapy']","['self-reported positive parenting behaviors', 'coherence between self-reported and observed parenting', 'parenting behaviors', 'negative parenting behaviors', 'parenting behavior change']","[{'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517540', 'cui_str': '115'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",229.0,0.0498308,"RESULTS
Greater reductions were found in self-reported negative parenting behaviors and observed negative affect and greater increases in self-reported positive parenting behaviors and observed positive affect among the caregivers in the treatment group.","[{'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13263']
1067,32464630,Dynamic Light Scattering: A New Noninvasive Technology for Neonatal Heart Rate Monitoring.,"BACKGROUND
Heart rate (HR) detection in premature infants using electrocardiography (ECG) is challenging due to a low signal amplitude and the fragility of the premature skin. Recently, the dynamic light scattering (DLS) technique has been miniaturized, allowing noninvasive HR measurements with a single sensor.
OBJECTIVE
The aim was to determine the accuracy of DLS for HR measurement in infants, compared to ECG-derived HR.
METHODS
Stable infants with a gestational age of ≥26 weeks, monitored with ECG, were eligible for inclusion. HR was measured with the DLS sensor at 5 different sites for 15 min each. We recorded every 10th second of the DLS-derived HR and the DLS signal-to-noise ratio (SNR), and the ECG-derived HR was extracted for analysis. Patients were randomly divided into 2 groups. In the first group, the optimal SNR cut-off value was determined and then applied to the second group to assess agreement.
RESULTS
HR measurements from 31 infants were analyzed. ECG-DLS paired data points were collected at the forehead, an upper extremity, the thorax, a lower extremity, and the abdomen. When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66). Application of this cut-off to the second group (n = 16) showed good agreement between DLS-derived HR and ECG-derived HR (bias -0.73 bpm; 95% limits of agreement -15.46 and 14.00 bpm) at the forehead with approximately 80% (i.e., 1,066/1,310) of all data pairs remaining.
CONCLUSION
The investigated DLS sensor was sensitive to movement, overall providing less accurate HR measurements than ECG and pulse oximetry. In this study population, specific measurement sites provided excellent signal quality and good agreement with ECG-derived HR.",2020,"When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66).","['premature infants using', 'Stable infants with a gestational age of ≥26 weeks, monitored with ECG, were eligible for inclusion']","['electrocardiography (ECG', 'Dynamic Light Scattering']",[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0023693', 'cui_str': 'Light'}]",[],31.0,0.0168291,"When applying the international accuracy standard for HR detection, DLS accuracy in the first group (n = 15) was optimal at the forehead (SNR cut-off 1.66).","[{'ForeName': 'Norani H', 'Initials': 'NH', 'LastName': 'Gangaram-Panday', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands, n.gangaram-panday@erasmusmc.nl.""}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'van Essen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Goos', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Rogier C J', 'Initials': 'RCJ', 'LastName': 'de Jonge', 'Affiliation': ""Pediatric Intensive Care Unit, Department of Pediatrics and Pediatric Surgery, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Irwin K M', 'Initials': 'IKM', 'LastName': 'Reiss', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'van Weteringen', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Erasmus MC - Sophia Children's Hospital, University Medical Center Rotterdam, Rotterdam, The Netherlands.""}]",Neonatology,['10.1159/000506771']
1068,32479166,Long-Term Rituximab Use to Maintain Remission of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Trial.,"BACKGROUND
Biannual rituximab infusions over 18 months effectively maintain remission after a ""standard"" remission induction regimen for patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV).
OBJECTIVE
To evaluate the efficacy of prolonged rituximab therapy in preventing AAV relapses in patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who have achieved complete remission after completing an 18-month maintenance regimen.
DESIGN
Randomized controlled trial. (ClinicalTrials.gov: NCT02433522).
SETTING
39 clinical centers in France.
PATIENTS
68 patients with GPA and 29 with MPA who achieved complete remission after the first phase of maintenance therapy.
INTERVENTION
Rituximab or placebo infusion every 6 months for 18 months (4 infusions).
MEASUREMENTS
The primary end point was relapse-free survival at month 28. Relapse was defined as new or reappearing symptoms or worsening disease, with a Birmingham Vasculitis Activity Score greater than 0.
RESULTS
From March 2015 to April 2016, 97 patients (mean age, 63.9 years; 35% women) were randomly assigned, 50 to the rituximab and 47 to the placebo group. Relapse-free survival estimates at month 28 were 96% (95% CI, 91% to 100%) and 74% (CI, 63% to 88%) in the rituximab and placebo groups, respectively, an absolute difference of 22% (CI, 9% to 36%) with a hazard ratio of 7.5 (CI, 1.67 to 33.7) ( P = 0.008). Major relapse-free survival estimates at month 28 were 100% (CI, 93% to 100%) versus 87% (CI, 78% to 97%) ( P = 0.009), respectively. At least 1 serious adverse event developed in 12 patients (24%) in the rituximab group (with 9 infectious serious adverse events occurring among 6 patients [12%]) versus 14 patients (30%) in the placebo group (with 6 infectious serious adverse events developing among 4 patients [9%]). No deaths occurred in either group.
LIMITATION
Potential selection bias based on previous rituximab response and tolerance.
CONCLUSION
Extended therapy with biannual rituximab infusions over 18 months was associated with a lower incidence of AAV relapse compared with standard maintenance therapy.
PRIMARY FUNDING SOURCE
French Ministry of Health and Hoffmann-La Roche.",2020,"Major relapse-free survival estimates at month 28 were 100% (CI, 93% to 100%) versus 87% (CI, 78% to 97%) ( P = 0.009), respectively.","['patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who have achieved complete remission after completing an 18-month maintenance regimen', 'Antineutrophil Cytoplasmic Antibody-Associated Vasculitis', 'From March 2015 to April 2016, 97 patients (mean age, 63.9 years; 35% women', '68 patients with GPA and 29 with MPA who achieved complete remission after the first phase of maintenance therapy', '39 clinical centers in France', 'patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV']","['placebo', 'Rituximab or placebo', 'rituximab', 'rituximab therapy']","['Relapse-free survival estimates', 'AAV relapse', 'Major relapse-free survival estimates', 'deaths', 'Relapse', 'relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0103647', 'cui_str': 'Anti neutrophilic cytoplasm antibody'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C4047978', 'cui_str': 'Rituximab therapy'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0042384', 'cui_str': 'Vasculitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",68.0,0.307403,"Major relapse-free survival estimates at month 28 were 100% (CI, 93% to 100%) versus 87% (CI, 78% to 97%) ( P = 0.009), respectively.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Charles', 'Affiliation': 'Cochin Hospital, Paris Descartes University, and Institut Mutualiste Montsouris, Paris, France (P.C.).'}, {'ForeName': 'Élodie', 'Initials': 'É', 'LastName': 'Perrodeau', 'Affiliation': ""Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, Sorbonne Paris Cité INSERM Unité 1153, Paris, France (É.P., P.R.).""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Samson', 'Affiliation': 'Centre Hospitalier Universitaire de Dijon, INSERM, UMR 1098, University of Bourgogne Franche-Comté, FHU INCREASE, Dijon, France (M.S., B.B.).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Bonnotte', 'Affiliation': 'Centre Hospitalier Universitaire de Dijon, INSERM, UMR 1098, University of Bourgogne Franche-Comté, FHU INCREASE, Dijon, France (M.S., B.B.).'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Néel', 'Affiliation': 'CRTI UMR 1064, INSERM, Université de Nantes, and Centre Hospitalier Universitaire Nantes, Nantes, France (A.N.).'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Agard', 'Affiliation': 'Centre Hospitalier Universitaire Nantes, Nantes, France (C.A.).'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Huart', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France (A.H., G.P.).'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Karras', 'Affiliation': 'Hôpital Européen Georges-Pompidou, Université Paris Descartes, Paris, France (A.K.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lifermann', 'Affiliation': 'Centre Hospitalier de Dax, Dax, France (F.L.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Godmer', 'Affiliation': 'Centre Hospitalier Bretagne Atlantique de Vannes, Vannes, France (P.G.).'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Cohen', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hanrotel-Saliou', 'Affiliation': 'Hôpital la Cavale Blanche, Centre Hospitalier Universitaire Brest, Brest, France (C.H.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Martin-Silva', 'Affiliation': 'Centre Hospitalier Universitaire de Caen, Caen, France (N.M.).'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Pugnet', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France (A.H., G.P.).'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maurier', 'Affiliation': 'Hôpitaux Privés de Metz, Metz, France (F.M.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Hôpital de Hautepierre, Centre Hospitalier Universitaire de Strasbourg, Strasbourg, France (J.S.).'}, {'ForeName': 'Pierre-Louis', 'Initials': 'PL', 'LastName': 'Carron', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France (P.C.).'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Clinique Rhône Durance, Avignon, France (P.G.).'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Meaux-Ruault', 'Affiliation': 'Centre Hospitalier Universitaire Jean-Minjoz, Besançon, France (N.M.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Le Gallou', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Rennes, France (T.L.).'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Vinzio', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France (S.V.).'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Viallard', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Pessac, France (J.V.).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hachulla', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Lille, France (E.H.).'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinter', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Terrier', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': ""Centre d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Université Paris Descartes, Sorbonne Paris Cité INSERM Unité 1153, Paris, France (É.P., P.R.).""}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Mouthon', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': 'Cochin Hospital, Paris Descartes University, Paris, France (P.C., C.V., X.P., B.T., L.M., L.G.).'}]",Annals of internal medicine,['10.7326/M19-3827']
1069,32468719,Bioequivalence Study of 2 Capsule Formulations of Fingolimod 0.5 mg Assessing Both Parent Drug and Active Metabolite in New Zealand Healthy Subjects (Truncated Design).,"Fingolimod is indicated for the treatment of patients with the relapsing-remitting form of multiple sclerosis. The primary study objective was to evaluate the bioequivalence of a test formulation, 0.5 mg fingolimod HCl capsule (Lebrina, Asofarma Sociedad Anónima Industrial y Comercial, Argentina) relative to a reference formulation, 0.5 mg fingolimod capsule (Gilenya, Novartis Pharmaceutical, Australia). In a single-center, randomized, single-dose, single-blinded, 2-way crossover study, 33 New Zealand healthy subjects of both sexes were enrolled to receive a 0.5-mg dose of 3 capsules of each fingolimod formulation under fasting conditions, with a 42-day washout period between administrations. Additional pharmacokinetic information regarding its main active metabolite, fingolimod phosphate, was also provided. The point estimate and 90% confidence intervals of the ratios of maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours were 99.07 (95.83-102.41) and 97.64 (95.33-100.00) for fingolimod, and 95.60 (90.95-100.49) and 98.54 (96.19-100.96), for fingolimod phosphate. Primary parameters, maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours for fingolimod and fingolimod phosphate were found to have no significant difference when test and reference formulations were compared. Fingolimod and fingolimod phosphate of both formulations were within the accepted 90% confidence interval limits of 80.00% and 125.00%. No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated. Notwithstanding the primary conclusion of bioequivalence is focused on the measurement of the parent compound, compliance with the same criteria by the active metabolite reinforces the comparability between the pharmacokinetic profiles of both formulations (ClinicalTrials.gov Identifier: NCT03757338).",2020,No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated.,"['patients with the relapsing-remitting form of multiple sclerosis', '33 New Zealand healthy subjects of both sexes', 'New Zealand Healthy Subjects (Truncated Design']","['Fingolimod', '0.5 mg Assessing Both Parent Drug and Active Metabolite', 'fingolimod HCl capsule ']","['maximum concentration and area under the plasma concentration-time curve from time 0 to 72 hours for fingolimod and fingolimod phosphate', 'ratios of maximum concentration and area under the plasma concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0388087', 'cui_str': 'Fingolimod hydrochloride'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",33.0,0.0636992,No significant differences between the test and reference drug products were detected in any of the pharmacokinetic parameters estimated.,"[{'ForeName': 'Noelyn Anne', 'Initials': 'NA', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Corporation Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Fernando Guillermo', 'Initials': 'FG', 'LastName': 'Costa', 'Affiliation': 'Asofarma S.A.I y C. (Asofarma Sociedad Anónima Industrial y Comercial), Buenos Aires, Argentina.'}, {'ForeName': 'Cheung-Tak', 'Initials': 'CT', 'LastName': 'Hung', 'Affiliation': 'Zenith Technology Corporation Ltd, Dunedin, New Zealand.'}, {'ForeName': 'Mónica Esther', 'Initials': 'ME', 'LastName': 'Rosenberg', 'Affiliation': 'Asofarma S.A.I y C. (Asofarma Sociedad Anónima Industrial y Comercial), Buenos Aires, Argentina.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.813']
1070,32464334,"Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial.","OBJECTIVES
The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.
METHODS
Data from 3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.
RESULTS
Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
CONCLUSIONS
Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.",2020,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","['3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18', 'young women', 'adult women ages 24 to 45 participating in a vaccine trial', 'adult women']","['9vHPV vaccine', 'anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59', 'vaccine']","['Overall, HPV incidence', 'incidence of persistent infection', 'Prevalence of anogenital infection', 'Prevalence, incidence, and natural history of HPV infection', 'HPV-related morbidity and mortality', 'Incidence of infections and persistent infections']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3817.0,0.148337,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","[{'ForeName': 'Daron G', 'Initials': 'DG', 'LastName': 'Ferris', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Cancer Center, 1120 15th Street, Augusta University, Augusta, GA, 30912, USA. Electronic address: dferris@augusta.edu.'}, {'ForeName': 'Darron R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Van Nuys Medical Science Building, Suite 224, 635 Barnhill Drive, Indianapolis, IN 46202, USA. Electronic address: darbrow@iupui.edu.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Giuliano', 'Affiliation': 'Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33612, USA. Electronic address: Anna.Giuliano@moffitt.org.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Duke Medicine Cir, Durham, NC, 27710, USA. Electronic address: evan.myers@duke.edu.'}, {'ForeName': 'Elmar A', 'Initials': 'EA', 'LastName': 'Joura', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Weinheimergrass 2, Medical University of Vienna, Vienna, 1160, Austria. Electronic address: elmar.joura@gmail.com.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Centre for Women's Infectious Diseases, The Royal Women's Hospital, Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Children's Research Institute, RWH, Locked Bag 300, Cnr Gratton St and Flemington Rd, Parkville, Victoria, 3052, Australia. Electronic address: Suzanne.Garland@thewomens.org.au.""}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen Denmark and Department of Gynecology, Rigshospitalet, Blegdamsvej 9, University of Copenhagen, Copenhagen, 2200, Denmark. Electronic address: susanne@cancer.dk.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: gonzalopamaya@gmail.com.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alfred_saah@merck.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alain_luxembourg@merck.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Velicer', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: christine_velicer@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100202']
1071,32476255,"Effects of dipeptidyl peptidase-4 inhibitor linagliptin versus sulphonylurea glimepiride on systemic haemodynamics in overweight patients with type 2 diabetes: A secondary analysis of an 8-week, randomized, controlled, double-blind trial.","AIM
To determine the glucose-independent effect of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin versus the sulphonylurea glimepiride on systemic haemodynamics in the fasting and postprandial state in patients with type 2 diabetes (T2D).
MATERIALS AND METHODS
In this prespecified secondary analysis of a phase IV, double-blind trial, 46 metformin-treated, overweight patients with T2D were included and randomly assigned (1:1) to once-daily linagliptin (5 mg) or glimepiride (1 mg) for 8 weeks. In a sub-study involving 26 patients, systemic haemodynamics were also assessed following a standardized liquid meal (Nutridrink Yoghurt style). Systemic haemodynamics (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry) and cardiac sympathovagal balance (heart rate variability [HRV]) were measured in the fasting state and repetitively following the meal. Ewing tests were performed in the fasting state.
RESULTS
From baseline to week 8, linagliptin compared with glimepiride did not affect systemic haemodynamics, arterial stiffness or HRV in the fasting state. Linagliptin increased parasympathetic nervous activity, as measured by the Valsalva manoeuvre (P = .021) and deep breathing test (P = .027) compared with glimepiride. Postprandially, systolic blood pressure (SBP) dropped an average of 7.6 ± 1.6 mmHg. Linagliptin reduced this decrease to 0.7 ± 2.3 mmHg, which was significant to glimepiride (P = .010).
CONCLUSIONS
When compared with glimepiride, linagliptin does not affect fasting blood pressure. However, linagliptin blunted the postprandial drop in SBP, which could benefit patients with postprandial hypotension.",2020,"RESULTS
From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","['46 metformin-treated, overweight T2DM patients', 'overweight patient with type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM']","['Linagliptin', 'glimepiride, linagliptin', 'sulfonylurea glimepiride', 'dipeptidyl peptidase (DPP)-4 inhibitor linagliptin', 'glimepiride', 'DPP-4 inhibitor linagliptin', 'linagliptin']","['systemic hemodynamics, arterial stiffness or HRV', 'systemic hemodynamics', 'fasting blood pressure', 'parasympathetic nervous activity', 'Systemic haemodynamic (oscillometric device and finger photoplethysmography), arterial stiffness (applanation tonometry), and cardiac sympathovagal balance (heart rate variability; HRV', 'Valsalva-manoeuvre', 'systemic haemodynamics']","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0162599', 'cui_str': 'Photoplethysmography'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042293', 'cui_str': 'Valsalva maneuver'}]",26.0,0.102531,"RESULTS
From baseline to Week-8, linagliptin compared to glimepiride did not affect systemic hemodynamics, arterial stiffness or HRV in the fasting state.","[{'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Kraaijenhof', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Tonneijck', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'D Margriet', 'Initials': 'DM', 'LastName': 'Ouwens', 'Affiliation': 'German Diabetes Center (DDZ), Leibniz Center for Diabetes Research, Heinrich Heine University, Medical Faculty, Düsseldorf, Germany.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}, {'ForeName': 'Mark M', 'Initials': 'MM', 'LastName': 'Smits', 'Affiliation': 'Diabetes Centre, Department of Internal Medicine, Amsterdam University Medical Centers, location VUmc, Amsterdam, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14107']
1072,32479591,Effect of an integrated care model for pre-frail and frail older people living in community.,"OBJECTIVES
to evaluate the effect of an integrated care model for pre-frail and frail community-dwelling older people.
DESIGN
a quasi-experimental design.
SETTING AND PARTICIPANTS
we enrolled people aged ≥60 years from a community care project. An inclusion criterion was pre-frailty/frailty, as measured by a simple frailty questionnaire (FRAIL) with a score of ≥1.
METHODS
we assigned participants to an intervention group (n = 183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n = 270) in which they received a group education session on frailty prevention. The outcomes were changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation over 12 months. Assessments were conducted at baseline and at the 12-month follow-up.
RESULTS
the mean age of the participants (n = 453) at baseline was 76.1 ± 7.5 years, and 363 (80.1%) were women. At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033). In addition, 22.4% of the intervention and 13.7% of the control participants had reverted from pre-frail/frail to robust status, with the difference reaching significance when the intervention was compared with the control group (odds ratio [OR] 1.6, 95% confidence interval [CI] 1.0-2.4) after adjustments for age, sex, living arrangement/marital status and hypercholesterolemia. For individual domains of frailty, the adjusted OR for improved 'resistance' was 1.7 (95% CI 1.0-2.8). However, no effects were found on reducing use of health services.
CONCLUSION
the integrated health and social care model reduced FRAIL scores in a combined population of pre-frail/frail community-dwelling older people attending older people's centres.",2020,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","['pre-frail and frail community-dwelling older people', 'enrolled people aged ≥60\xa0years from a community care project', ""combined population of pre-frail/frail community-dwelling older people attending older people's centres"", 'the mean age of the participants (n\u2009=\u2009453) at baseline was 76.1\u2009±\u20097.5\xa0years, and 363 (80.1%) were women', 'pre-frail and frail older people living in community']","['integrated care model', 'intervention group (n\u2009=\u2009183) in which they received an integrated intervention (in-depth assessment, personalised care plans and coordinated care) or a control group (n\u2009=\u2009270) in which they received a group education session on frailty prevention']","['FRAIL scores', ""changes in frailty, individual domains of frailty ('fatigue', 'resistance', 'ambulation', 'illnesses' and 'loss of weight') and health services utilisation""]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]",,0.0395423,"At follow-up, the intervention group showed significantly greater reductions in FRAIL scores than the control group (P < 0.033).","[{'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Tong', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Jockey Club Institute of Ageing, The Chinese University of Hong Kong, Hong Kong, SAR, China.'}]",Age and ageing,['10.1093/ageing/afaa087']
1073,32469182,Trastuzumab Deruxtecan in Previously Treated HER2-Positive Gastric Cancer.,"BACKGROUND
Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate consisting of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor. The drug may have efficacy in patients with HER2-positive advanced gastric cancer.
METHODS
In an open-label, randomized, phase 2 trial, we evaluated trastuzumab deruxtecan as compared with chemotherapy in patients with HER2-positive advanced gastric cancer. Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including trastuzumab, were randomly assigned in a 2:1 ratio to receive trastuzumab deruxtecan (6.4 mg per kilogram of body weight every 3 weeks) or physician's choice of chemotherapy. The primary end point was the objective response, according to independent central review. Secondary end points included overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety.
RESULTS
Of 187 treated patients, 125 received trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel). An objective response was reported in 51% of the patients in the trastuzumab deruxtecan group, as compared with 14% of those in the physician's choice group (P<0.001). Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]). The most common adverse events of grade 3 or higher were a decreased neutrophil count (in 51% of the trastuzumab deruxtecan group and 24% of the physician's choice group), anemia (38% and 23%, respectively), and decreased white-cell count (21% and 11%). A total of 12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee. One drug-related death (due to pneumonia) was noted in the trastuzumab deruxtecan group; no drug-related deaths occurred in the physician's choice group.
CONCLUSIONS
Therapy with trastuzumab deruxtecan led to significant improvements in response and overall survival, as compared with standard therapies, among patients with HER2-positive gastric cancer. Myelosuppression and interstitial lung disease were the notable toxic effects. (Funded by Daiichi Sankyo; DESTINY-Gastric01 ClinicalTrials.gov number, NCT03329690.).",2020,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","['12 patients had trastuzumab deruxtecan-related interstitial lung disease or pneumonitis (grade 1 or 2 in 9 patients and grade 3 or 4 in 3), as adjudicated by an independent committee', 'patients with HER2-positive gastric cancer', 'patients with HER2-positive advanced gastric cancer', '187 treated patients', 'Previously Treated HER2-Positive Gastric Cancer', 'Patients with centrally confirmed HER2-positive gastric or gastroesophageal junction adenocarcinoma that had progressed while they were receiving at least two previous therapies, including']","['trastuzumab', 'trastuzumab deruxtecan', 'trastuzumab deruxtecan and 62 chemotherapy (55 received irinotecan and 7 paclitaxel', ""physician's choice of chemotherapy"", 'Trastuzumab Deruxtecan', 'chemotherapy']","['overall survival, response duration, progression-free survival, confirmed response (response persisting ≥4 weeks), and safety', 'neutrophil count', 'Overall survival', 'objective response', 'anemia', 'Myelosuppression and interstitial lung disease', 'white-cell count', 'response and overall survival']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",187.0,0.240051,"Overall survival was longer with trastuzumab deruxtecan than with chemotherapy (median, 12.5 vs. 8.4 months; hazard ratio for death, 0.59; 95% confidence interval, 0.39 to 0.88; P = 0.01, which crossed the prespecified O'Brien-Fleming boundary [0.0202 on the basis of number of deaths]).","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Shitara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwasa', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hyun-Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kaku', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kamio', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Kojima', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sugihara', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'From the National Cancer Center Hospital East, Kashiwa (K. Shitara), the National Cancer Center Hospital (S.I.), Daiichi Sankyo (T.K., A.K., M.S.), and the Cancer Institute Hospital of JFCR (K.Y.), Tokyo, the Osaka International Cancer Institute (N.S.), Osaka University Hospital (D.S.), and Kindai University Hospital (H.K.), Osaka, and Niigata Cancer Center Hospital, Niigata (H.Y.) - all in Japan; Seoul National University College of Medicine (Y.-J.B.), the Asan Medical Center, University of Ulsan College of Medicine (M.-H.R.), the Yonsei Cancer Center, Yonsei University College of Medicine (H.-C.C.), and the Samsung Medical Center, Sungkyunkwan University School of Medicine (J.L.) - all in Seoul, South Korea; and Daiichi Sankyo, Basking Ridge, NJ (K. Saito, Y.K.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004413']
1074,32484534,"Effect of C-Reactive Protein-Guided Antibiotic Treatment Duration, 7-Day Treatment, or 14-Day Treatment on 30-Day Clinical Failure Rate in Patients With Uncomplicated Gram-Negative Bacteremia: A Randomized Clinical Trial.","Importance
Antibiotic overuse drives antibiotic resistance. Gram-negative bacteremia is a common infection that results in substantial antibiotic use.
Objective
To compare the clinical effectiveness of C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations 30, 60, and 90 days after treatment initiation.
Design, Setting, and Participants
Multicenter, noninferiority, point-of-care randomized clinical trial including adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019. Patients and physicians were blinded between randomization and antibiotic discontinuation. Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression.
Intervention
Randomization in a 1:1:1 ratio to an individualized CRP-guided antibiotic treatment duration (discontinuation once CRP declined by 75% from peak; n = 170), fixed 7-day treatment duration (n = 169), or fixed 14-day treatment duration (n = 165).
Main Outcomes and Measures
The primary outcome was the clinical failure rate at day 30, defined as the presence of at least 1 of the following, with a non-inferiority margin of 10%: recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause. Secondary outcomes included the clinical failure rate on day 90 of follow-up.
Results
Among 504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up. Median antibiotic duration in the CRP group was 7 (interquartile range, 6-10; range, 5-28) days; 34 of the 164 patients (21%) who completed the 30-day follow-up had protocol violations related to treatment assignment. The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001). By day 90, clinical failure occurred in 10 of 143 patients (7.0%) in the CRP group, 16 of 151 (10.6%) in the 7-day group, and 16 of 153 (10.5%) in the 14-day group.
Conclusions and Relevance
Among adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment were noninferior to fixed 14-day treatment. However, interpretation is limited by the large noninferiority margin compared with the low observed event rate, as well as low adherence and wide range of treatment durations in the CRP-guided group.
Trial Registration
ClinicalTrials.gov Identifier: NCT03101072.",2020,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","['Adults (aged ≥18 years) were eligible for randomization on day 5 (±1 d) of microbiologically efficacious therapy for fermenting, gram-negative bacteria in blood culture(s) if they were afebrile for 24 hours without evidence for complicated infection (eg, abscess) or severe immunosuppression', 'With Uncomplicated Gram-Negative Bacteremia', 'Patients', 'adults hospitalized with gram-negative bacteremia conducted in 3 Swiss tertiary care hospitals between April 2017 and May 2019, with follow-up until August 2019', 'adults with uncomplicated gram-negative bacteremia, 30-day rates of clinical failure for CRP-guided antibiotic treatment duration and fixed 7-day treatment', '504 patients randomized (median [interquartile range] age, 79 [68-86] years; 306 of 503 [61%] were women), 493 (98%) completed 30-day follow-up and 448 (89%) completed 90-day follow-up']","['individualized CRP-guided antibiotic treatment duration (discontinuation once CRP', 'C-reactive protein (CRP)-guided, 7-day, and 14-day antibiotic durations', 'C-Reactive Protein-Guided Antibiotic']","['clinical failure rate', 'Median antibiotic duration', 'clinical failure rate on day 90 of follow-up', '30-Day Clinical Failure Rate', 'recurrent bacteremia, local suppurative complication, distant complication (growth of the same organism causing the initial bacteremia), restarting gram-negative-directed antibiotic therapy due to clinical worsening suspected to be due to the initial organism, or death due to any cause', 'clinical failure']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018150', 'cui_str': 'Gram-negative bacterium'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C3160894', 'cui_str': 'Complicated infection'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0744471', 'cui_str': 'Gram-negative bacteremia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C3203360', 'cui_str': 'Suppuration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",504.0,0.162586,"The primary outcome occurred in 4 of 164 (2.4%) patients in the CRP group, 11 of 166 (6.6%) in the 7-day group, and 9 of 163 (5.5%) in the 14-day group (difference in CRP vs 14-day group, -3.1% [1-sided 97.5% CI, -∞ to 1.1]; P < .001; difference in 7-day vs 14-day group, 1.1% [1-sided 97.5% CI, -∞ to 6.3]; P < .001).","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'von Dach', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Werner C', 'Initials': 'WC', 'LastName': 'Albrich', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Brunel', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Prendki', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Clémence', 'Initials': 'C', 'LastName': 'Cuvelier', 'Affiliation': 'Faculty of Medicine, Division of Internal Medicine of the Aged, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Flury', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Gayet-Ageron', 'Affiliation': 'Faculty of Medicine, Clinical Research Center, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lemmenmeier', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, Cantonal Hospital St Gallen, St Gallen, Switzerland.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'McCallin', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rossel', 'Affiliation': 'Department of Internal Medicine, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Bochud', 'Affiliation': 'Infectious Diseases Service, University Hospital, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Huttner', 'Affiliation': 'Faculty of Medicine, Division of Infectious Diseases, Geneva University Hospitals, Geneva, Switzerland.'}]",JAMA,['10.1001/jama.2020.6348']
1075,32487465,Medial temporal lobe cortical changes in response to exercise interventions in people with early psychosis: A randomized controlled trial.,"OBJECTIVE
Individuals with early psychosis may have prefrontal-limbic cortical deficits, which are associated with symptom severity and cognitive impairment. This study investigated the impact of an exercise intervention on fronto-temporal cortical plasticity in female participants with early psychosis.
METHODS
In a cohort of 51 female participants with early psychosis from Hong Kong, we investigated the effects of a 12-week, moderate intensity aerobic or Hatha yoga exercise trial (yoga (N = 21), aerobic (N = 18) or waitlist group (N = 12)) on cortical grey matter. Clinical assessments and structural MRI were completed pre- and post- a 12-week exercise intervention.
RESULTS
Increases in cortical volume and thickness were observed in the medial temporal cortical regions, primarily in fusiform cortical thickness (F(2, 48) = 4.221, p = 0.020, η 2 = 0.150) and volume (F(2, 48) = 3.521, p = 0.037, η 2 = 0.128) for participants with early psychosis in the aerobic arm, but not in the yoga and waitlist arms. Increased fusiform cortical thickness (ß = 0.402, p = 0.003) was associated with increased hippocampal volume for all psychosis participants. For the aerobic group only, increases in the entorhinal and fusiform temporal gyri were associated with reduced symptom severity.
CONCLUSIONS
These findings suggest exercise-induced neuroplasticity in medial temporal cortical regions occurs with aerobic exercise. These changes may be associated with improvements in psychosis symptom severity. People with early psychosis may benefit from exercise interventions, particularly aerobic exercise, as an adjunct treatment to address clinical, physical health, and neuroanatomic concerns. NIH National Library of Medicine ClinicalTrials.gov Registration #: NCT01207219https://clinicaltrials.gov/ct2/show/NCT01207219.",2020,"For the aerobic group only, increases in the entorhinal and fusiform temporal gyri were associated with reduced symptom severity.
","['Individuals with early psychosis', 'people with early psychosis', 'female participants with early psychosis', 'People with early psychosis', '51 female participants with early psychosis from Hong Kong']","['moderate intensity aerobic or Hatha yoga exercise trial (yoga (N\xa0=\xa021), aerobic (N\xa0=\xa018) or waitlist group (N\xa0=\xa012)) on cortical grey matter', 'exercise interventions', 'exercise intervention']","['hippocampal volume', 'Increased fusiform cortical thickness', 'medial temporal cortical regions, primarily in fusiform cortical thickness (F(2, 48)\xa0', 'psychosis symptom severity', 'cortical volume and thickness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332493', 'cui_str': 'Fusiform shape'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",51.0,0.148747,"For the aerobic group only, increases in the entorhinal and fusiform temporal gyri were associated with reduced symptom severity.
","[{'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Woodward', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Canada.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'School of Nursing, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Gicas', 'Affiliation': 'Department of Psychology, York University, Canada.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Canada.'}, {'ForeName': 'Christy L M', 'Initials': 'CLM', 'LastName': 'Hui', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Honer', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Canada.'}, {'ForeName': 'Eric Y H', 'Initials': 'EYH', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Lang', 'Affiliation': 'Department of Radiology, University of British Columbia, Canada. Electronic address: dlang@mail.ubc.ca.'}]",Schizophrenia research,['10.1016/j.schres.2020.05.043']
1076,32472611,Novel dose escalation to predict treatment with hydroxyurea (NDEPTH): A randomized controlled trial of a dose-prediction equation to determine maximum tolerated dose of hydroxyurea in pediatric sickle cell disease.,,2020,,['Pediatric Sickle Cell Disease'],"['Hydroxyurea (NDEPTH', 'Hydroxyurea']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]",[],,0.125772,,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'George', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Dinu', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Estrada', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hurwitz', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Mahoney', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Yates', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Alaundra', 'Initials': 'A', 'LastName': 'Carmouche', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Gladstone', 'Initials': 'G', 'LastName': 'Airewele', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kirk', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Titilope', 'Initials': 'T', 'LastName': 'Fasipe', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Precious', 'Initials': 'P', 'LastName': 'Uwaezuoke', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Ware', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}]",American journal of hematology,['10.1002/ajh.25883']
1077,32474978,"""I don't think I took her fears seriously"": Exploring the experiences of family members of individuals at-risk of developing psychosis over 12 months.","Individuals with an at-risk mental state (ARMS) of psychosis experience high levels of distress, anxiety, low mood, and suicidal ideation. Families of ARMS individuals provide significant support but are often neglected by services. This study is the first of its kind to use a novel longitudinal qualitative methodology to directly compare family/carers' earlier experiences supporting ARMS individuals to 12 months later. This provides a more ecologically valid insight into how perceptions change over time and how family/carers adapt. Semistructured interviews were conducted with 10 family/carers at two points within a 12-month period. This study was embedded within a randomized control trial, the Individual and Family Cognitive Behavioural Therapy trial. Interview transcripts were analysed using thematic analysis, with a focus on how experiences and reactions for family/carers changed over time. Over 12 months, four factors were important for family/carers to facilitate their caring role. These were summarized in the thematic map (LACE model): Looking after your own well-being; Accessing additional support from family intervention; Communicating openly with the individual; and Engaging with services for the individual. All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs, and helping them to feel more confident and less isolated in their carer role. Novel implications suggest that when feasible, services should involve family/carers of ARMS individuals in sessions and explore family/carer support strategies in managing their own distress. The most significant insight was the need to develop family/carer resources to educate, normalize, and validate their own experiences.",2020,"All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs and helping them to feel more confident and less isolated in their carer role.","['Individuals with an At Risk Mental State (ARMS) of psychosis experience high-levels of distress, anxiety, low mood and suicidal ideation']",['Individual and Family Cognitive Behavioural Therapy (IFCBT'],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0176856,"All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs and helping them to feel more confident and less isolated in their carer role.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Izon', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Berry', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Law', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Division of Psychology & Mental Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Pennine Care NHS Foundation Trust, Ashton-under-Lyne, UK.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2483']
1078,32484261,Long-term effects of high-intensity training vs moderate intensity training in heart transplant recipients: A 3-year follow-up study of the randomized-controlled HITTS study.,"The randomized controlled High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia (HITTS) study compared 9 months of high-intensity interval training (HIT) with moderate intensity continuous training in de novo heart transplant recipients. In our 3-year follow-up study, we aimed to determine whether the effect of early initiation of HIT on peak oxygen consumption (VO 2peak ) persisted for 2 years postintervention. The study's primary end point was the change in VO 2peak (mL/kg/min). The secondary end points were muscle strength, body composition, heart rate response, health-related quality of life, daily physical activity, biomarkers, and heart function. Of 78 patients who completed the 1-year HITTS trial, 65 entered our study and 62 completed the study tests. VO 2peak increased from baseline to 1 year and leveled off thereafter. During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak . However, the mean change in the anaerobic threshold and extensor muscle endurance remained significantly higher in the HIT group. Early initiation of HIT after heart transplantation appears to have some sustainable long-term effects. Clinical trial registration number: NCT01796379.",2020,"During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak .","['De Novo Heart Transplant Recipients in Scandinavia (HITTS', 'heart transplant recipients', '78 patients who completed the 1-year HITTS trial, 65 entered our study and 62 completed the study tests', 'in de novo heart transplant recipients']","['Intensity Interval Training', 'high-intensity interval training (HIT) with moderate intensity continuous training', 'high-intensity training vs. moderate intensity training']","['VO 2peak', 'change in VO 2peak (mL/kg/min', 'peak oxygen consumption (VO 2peak ', 'muscle strength, body composition, heart rate response, health-related quality of life, daily physical activity, biomarkers and heart function', 'anaerobic threshold and extensor muscle endurance']","[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",78.0,0.0659216,"During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak .","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Arne K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Authen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16087']
1079,32479750,A Randomized Controlled Trial of the Lowest Effective Dose of Acetazolamide for Acute Mountain Sickness Prevention.,"BACKGROUND
Acetazolamide is the most common medication used for acute mountain sickness prevention, with speculation that a reduced dose may be as efficacious as standard dosing with fewer side effects.
METHODS
This double-blind, randomized, controlled noninferiority trial compared acetazolamide 62.5 mg twice daily to the standard dose acetazolamide 125 mg twice daily starting the evening prior to ascent from 1240 m (4100 ft) to 3810 m (12,570 ft) over 4 hours. The primary outcome was acute mountain sickness incidence (ie, headache, Lake Louise Questionnaire ≥3, and another symptom).
RESULTS
A total of 106 participants were analyzed, with 51 (48%) randomized to 125 mg and 55 (52%) to 62.5 mg, with a combined acute mountain sickness incidence of 53 (50%) and mean severity of 3 (± 2.1). The 62.5-mg group failed to fall within the prespecified 26% noninferiority margin for acute mountain sickness incidence (62.5 mg = 30 [55%] vs 125 mg = 23 [45%], 95% confidence interval [CI] -11% to 30%). Participants in the 62.5-mg group had a higher risk of acute mountain sickness (odds ratio = 1.5, 95% CI 0.7-3.2) and moderate acute mountain sickness (odds ratio = 1.8, 95% CI 0.6-5.9), with a number needed to harm (NNH) of 9, with a number needed to treat (NNT) in the 125-mg group of 4.8. Increased acute mountain sickness incidence and symptom severity corresponded to lower weight-based and body mass index dosing, with similar side effects between groups.
CONCLUSION
Acetazolamide 62.5 mg twice daily failed to demonstrate equal effectiveness to 125 mg twice daily for prevention of acute mountain sickness. With increased risk and no demonstrable symptomatic or physiologic benefits, acetazolamide 62.5 mg twice daily should not be recommended for acute mountain sickness prevention.",2020,"Participants in the 62.5 mg group had a higher risk of acute mountain sickness (OR = 1.5, 95% CI 0.7 to 3.2) and moderate acute mountain sickness (OR = 1.8, 95% CI 0.6 to 5.9), with a NNH of 9, with a NNT in the 125 mg group of 4.8.","['106 participants', 'Acute Mountain Sickness Prevention']","['acetazolamide', 'Acetazolamide']","['higher risk of acute mountain sickness', 'acute mountain sickness incidence and symptom severity', 'moderate acute mountain sickness', 'acute mountain sickness incidence', 'acute mountain sickness incidence (headache and Lake Louise Questionnaire ≥ 3 and another symptom']","[{'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",106.0,0.0551059,"Participants in the 62.5 mg group had a higher risk of acute mountain sickness (OR = 1.5, 95% CI 0.7 to 3.2) and moderate acute mountain sickness (OR = 1.8, 95% CI 0.6 to 5.9), with a NNH of 9, with a NNT in the 125 mg group of 4.8.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Lipman', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, Calif. Electronic address: grantlip@hotmail.com.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Jurkiewicz', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Burnier', 'Affiliation': 'Stanford Emergency Medicine Residency, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marvel', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Department of Computational Science, University of Colorado, Golden.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Lowry', 'Affiliation': 'MountainView Regional Medical Center, Las Cruces, NM.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hawkins', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Navlyt', 'Affiliation': 'Stanford Emergency Medicine Residency, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Swenson', 'Affiliation': 'Medical Service, VA Puget Sound Health Care System, and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.05.003']
1080,32479794,"Tepotinib plus gefitinib in patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study): an open-label, phase 1b/2, multicentre, randomised trial.","BACKGROUND
We evaluated the efficacy and safety of tepotinib, a potent and highly selective oral MET inhibitor, plus gefitinib in patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition.
METHODS
In this open-label, phase 1b/2, multicentre, randomised trial (the INSIGHT study), we enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries. In phase 1b, patients received oral tepotinib 300 mg or 500 mg plus gefitinib 250 mg once daily. In phase 2, patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification were randomly assigned (initially in a 1:1 ratio and then 2:1 following a protocol amendment) to tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy. Randomisation was done centrally via an interactive voice-response system. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS) and safety. Subgroup analyses were preplanned in patients with high MET overexpression (IHC3+) or MET amplification (mean gene copy number ≥5 or MET to centromere of chromosome 7 ratio ≥2). Efficacy and patient characteristics were assessed on an intention-to-treat basis and safety was assessed for all patients who received at least one dose of study medication. Low recruitment led to early termination of phase 2, so all analyses are considered to be exploratory. This study is registered with ClinicalTrials.gov, NCT01982955, and the European Union Drug Regulating Authorities Clinical Trials Database, Eudra-CT 2016-001604-28.
FINDINGS
From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group; n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group; n=24 in the chemotherapy group). No dose-limiting toxicities were observed in phase 1b, so tepotinib 500 mg was used as the recommended phase 2 dose. In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio [HR] 0·67, 90% CI 0·35-1·28). Median OS was 17·3 months in the tepotinib plus gefitinib group (12·1-37·3) versus 18·7 months in the chemotherapy group (15·9-20·7; HR 0·69, 0·34-1·41). PFS and OS were longer with tepotinib plus gefitinib than with chemotherapy in patients with high (IHC3+) MET overexpression (n=34; median PFS 8·3 months [4·1-16·6] vs 4·4 months [4·1-6·8]; HR 0·35, 0·17-0·74; median OS 37·3 months [90% CI 24·2-37·3] vs 17·9 months [12·0-20·7]; HR 0·33, 0·14-0·76) or MET amplification (n=19; median PFS 16·6 months [8·3-not estimable] vs 4·2 months [1·4-7·0]; HR 0·13, 0·04-0·43; median OS 37·3 months [90% CI not estimable] vs 13·1 months [3·25-not estimable]; HR 0·08, 0·01-0·51). The most frequent treatment-related grade 3 or worse adverse events were increased amylase (5 [16%] of 31 patients) and lipase (4 [13%]) concentrations in the tepotinib plus gefitinib group and anaemia (7 [30%] of 23 patients) and decreased neutrophil count (3 [13%]) in the chemotherapy group.
INTERPRETATION
Despite early study termination, in a preplanned subgroup analysis, our findings suggest improved anti activity for tepotinib plus gefitinib compared with standard chemotherapy in patients with EGFR-mutant NSCLC and MET amplification, warranting further exploration.
FUNDING
Merck KGaA.",2020,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","['From Dec 23, 2013, to May 25, 2017, 18 patients were enrolled in phase 1b (n=6 in the 300 mg tepotinib group', 'patients with epidermal growth factor receptor (EGFR)-mutant non-small-cell lung cancer (NSCLC) with MET overexpression (immunohistochemistry [IHC]2+ or IHC3+) or MET amplification having acquired resistance to EGFR inhibition', 'patients with EGFR-mutant non-small-cell lung cancer with MET overexpression or MET amplification and acquired resistance to previous EGFR inhibitor (INSIGHT study', 'n=12 in the 500 mg tepotinib group) and 55 patients in phase 2 (n=31 in the tepotinib plus gefitinib group', 'patients with EGFR-mutant, T790M-negative NSCLC MET overexpression or MET amplification', 'n=24 in the chemotherapy group', 'enrolled adult patients (≥18 years) with advanced or metastatic NSCLC, and Eastern Cooperative Oncology Group performance status of 0 or 1, from academic medical centres and community clinics in six Asian countries']","['Tepotinib plus gefitinib', 'standard chemotherapy', 'oral tepotinib 300 mg or 500 mg plus gefitinib', 'tepotinib plus gefitinib at the recommended phase 2 dose or to standard platinum doublet chemotherapy']","['investigator-assessed progression-free survival (PFS', 'anti activity', 'Median OS', 'neutrophil count', 'median PFS', 'anaemia', 'intention-to-treat basis and safety', 'adverse events', 'PFS and OS', 'No dose-limiting toxicities', 'overall survival (OS) and safety', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C0454705', 'cui_str': 'Asian country'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",18.0,0.166598,"In phase 2, survival outcomes were similar between groups: median PFS was 4·9 months in the tepotinib plus gefitinib group (90% CI 3·9-6·9) versus 4·4 months in the chemotherapy group (90% CI 4·2-6·8; hazard ratio","[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Chest Hospital, Shanghai, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ross Andrew', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'National University Cancer Institute, Singapore.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital, Zhejiang Medical University, Zhejiang, China.'}, {'ForeName': 'Yuh-Min', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Chest Medicine, Taipei Veteran General Hospital and School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chih-Feng', 'Initials': 'CF', 'LastName': 'Chian', 'Affiliation': 'Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Affiliated Hospital of Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Daniel Shao Weng', 'Initials': 'DSW', 'LastName': 'Tan', 'Affiliation': 'National Cancer Center, Singapore.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Bruns', 'Affiliation': 'Biostatistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Straub', 'Affiliation': 'Translational Medicine, Department of Clinical Biomarkers and Companion Diagnostics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Johne', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Scheele', 'Affiliation': 'Global Clinical Development, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30154-5']
1081,32482120,Perceived Patient Pain and Spousal Caregivers' Negative Affect: The Moderating Role of Spouse Confidence in Patients' Pain Management.,"Objectives: This study examined whether older patients' greater daily pain perceived by their spouses was associated with spouses' higher daily negative affect. We further investigated whether spouses' lower confidence in patients' ability to manage pain exacerbated the daily association between perceived patient pain and spouses' negative affect. Method: We used baseline interviews and a 22-day diary of knee osteoarthritis patients and their spouses ( N = 144 couples). Multilevel models were estimated to test hypotheses. Results: Daily perceived patient pain was not associated with spouses' daily negative affect. However, spouse confidence significantly moderated the association. Only spouses with lower confidence in patients' pain management experienced higher negative affect on days when they perceived that patients' level of pain was higher than usual. Discussion: Findings suggest that spousal caregivers' lack of confidence in patients' pain management may be a risk factor for spouses' affective distress in daily life.",2020,Only spouses with lower confidence in patients' pain management experienced higher negative affect on days when they perceived that patients' level of pain was higher than usual. ,"['knee osteoarthritis patients and their spouses ( N = 144 couples', ""Patients' Pain Management"", 'older patients']",[],"['patient pain', 'level of pain', 'greater daily pain']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",144.0,0.0426678,Only spouses with lower confidence in patients' pain management experienced higher negative affect on days when they perceived that patients' level of pain was higher than usual. ,"[{'ForeName': 'Suyoung', 'Initials': 'S', 'LastName': 'Nah', 'Affiliation': 'The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Martire', 'Affiliation': 'The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Ruixue', 'Initials': 'R', 'LastName': 'Zhaoyang', 'Affiliation': 'The Pennsylvania State University, University Park, Pennsylvania.'}]",Journal of aging and health,['10.1177/0898264320919631']
1082,32484533,Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial.,"Importance
Reducing cesarean delivery rates in the US is an important public health goal; despite evidence of the safety of vaginal birth after cesarean delivery, most women have scheduled repeat cesarean deliveries. A decision support tool could help increase trial-of-labor rates.
Objective
To analyze the effect of a patient-centered decision support tool on rates of trial of labor and vaginal birth after cesarean delivery and decision quality.
Design, Setting, and Participants
Multicenter, randomized, parallel-group clinical trial conducted in Boston, Chicago, and the San Francisco Bay area. A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019.
Interventions
Participants were randomized to use a tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool) (n=743).
Main Outcomes and Measures
The primary outcome was trial of labor; vaginal birth was the main secondary outcome. Other secondary outcomes focused on maternal and neonatal outcomes and decision quality.
Results
Among 1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n = 735 in both randomization groups) and were included in the analysis. Trial-of-labor rates did not differ significantly between intervention and control groups (43.3% vs 46.2%, respectively; adjusted absolute risk difference, -2.78% [95% CI, -7.80% to 2.25%]; adjusted relative risk, 0.94 [95% CI, 0.84-1.05]). There were no statistically significant differences in vaginal birth rates (31.8% in both groups; adjusted absolute risk difference, -0.04% [95% CI, -4.80% to 4.71%]; adjusted relative risk, 1.00 [95% CI, 0.86-1.16]) or in any of the other 6 clinical maternal and neonatal secondary outcomes. There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38 [95% CI, -1.81 to 1.05]; scores >25 are considered clinically important).
Conclusions and Relevance
Among women with 1 previous cesarean delivery, use of a decision support tool compared with usual care did not significantly change the rate of trial of labor. Further research may be needed to assess the efficacy of this tool in other clinical settings or when implemented at other times in pregnancy.",2020,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","['1485 patients (mean age, 34.0 [SD, 4.5] years), 1470 (99.0%) completed the trial (n\u2009=\u2009735 in both randomization groups) and were included in the analysis', 'women with 1 previous cesarean delivery', 'A total of 1485 English- or Spanish-speaking women with 1 prior cesarean delivery and no contraindication to trial of labor were enrolled between January 2016 and January 2019; follow-up was completed in June 2019']","[""tablet-based decision support tool prior to 25 weeks' gestation (n=742) or to receive usual care (without the tool"", 'patient-centered decision support tool', 'Patient-Centered Decision Support Tool']","['labor; vaginal birth', 'labor rates', 'cesarean delivery rates', '5 decision quality measures (eg, mean decisional conflict scores', 'Rates of Trial of Labor', 'rate of trial of labor', 'rates of trial of labor and vaginal birth', 'vaginal birth rates', 'maternal and neonatal outcomes and decision quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0870393', 'cui_str': 'Decision support tool'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040862', 'cui_str': 'Trial labor'}, {'cui': 'C0005608', 'cui_str': 'Birth Rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.215832,"There also were no significant differences between the intervention and control groups in the 5 decision quality measures (eg, mean decisional conflict scores were 17.2 and 17.5, respectively; adjusted mean difference, -0.38","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Anjali J', 'Initials': 'AJ', 'LastName': 'Kaimal', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Cinthia', 'Initials': 'C', 'LastName': 'Blat', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Mari-Paule', 'Initials': 'MP', 'LastName': 'Thiet', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco.'}, {'ForeName': 'Yamilee', 'Initials': 'Y', 'LastName': 'Bermingham', 'Affiliation': 'Marin Community Clinic, San Rafael, California.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Altshuler', 'Affiliation': 'California Pacific Medical Center, San Francisco.'}, {'ForeName': 'Allison S', 'Initials': 'AS', 'LastName': 'Bryant', 'Affiliation': 'Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Feinberg School of Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois.'}]",JAMA,['10.1001/jama.2020.5952']
1083,32480252,The Efficacy of Lidocaine in Disrupting Cocaine Cue-Induced Memory Reconsolidation.,"RATIONAL
Cue-induced craving memories, linked to drug-seeking behaviors, require key molecular processes for memory reconsolidation. Lidocaine, a sodium channel blocker, inhibits NMDA receptor activation and suppresses nitric oxide and ERK production. These processes are required for memory re-consolidation; inhibiting them may reduce cue-related craving memories in cocaine dependent subjects.
OBJECTIVES
To assess the efficacy of lidocaine in decreasing cue-induced cocaine craving and cocaine use.
METHODS
Treatment-seeking cocaine-dependent participants (n = 33, 25 men) were recruited. Personalized craving and relaxation scripts were developed. Participants were then randomly assigned in a double-blind design to either receive intravenous lidocaine immediately following a cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax). One week following the infusion, cue-induced craving was assessed in the same paradigm without an infusion. Cocaine use and craving were assessed for 4 weeks following infusion.
RESULTS
The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group. There were no significant differences in craving and cocaine use between the lidocaine/relax and saline/craving groups.
CONCLUSION
Lidocaine administered following craving induction did not decrease subsequent cue-induced craving or cocaine use. Blocking the reconsolidation of craving-related memories with pharmacological agents remains an important area of investigation.",2020,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"['Treatment-seeking cocaine-dependent participants (n = 33, 25 men']","['Lidocaine', 'lidocaine/craving', 'lidocaine', 'intravenous lidocaine', 'cocaine craving script (lidocaine/craving), saline following a craving script (saline/craving), or lidocaine following a relaxation script (lidocaine/relax', 'Cocaine']",['craving and cocaine'],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",,0.054462,The administration of lidocaine during craving induction (lidocaine/craving) did not decrease cue-induced craving during craving reactivation one week later or craving and cocaine use over the 4-week follow-up period compared to the saline/craving group.,"[{'ForeName': 'Josh E', 'Initials': 'JE', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Julianne L', 'Initials': 'JL', 'LastName': 'Price', 'Affiliation': 'Department of Psychiatry, University of Florida, Gainesville, FL USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leonard', 'Affiliation': 'David Leonard Statistical Consulting, Wichita Falls, TX USA.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Suris', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Enas', 'Initials': 'E', 'LastName': 'Kandil', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA; Department of Anesthesiology & Pain Management, UT Southwestern Medical Center, Dallas, TX USA; School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA; VA North Texas Health Care System, Dallas, TX USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Kroener', 'Affiliation': 'School of Behavior and Brain Sciences, UT Dallas, Dallas, TX USA.'}, {'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, UT Southwestern Medical Center, Dallas, TX USA.'}, {'ForeName': 'Bryon', 'Initials': 'B', 'LastName': 'Adinoff', 'Affiliation': 'Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108062']
1084,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE
The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression.
METHOD
A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression.
RESULTS
A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001).
CONCLUSION
These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145']
1085,32488245,Effectiveness of a Khorasan Wheat-Based Replacement on Pain Symptoms and Quality of Life in Patients with Fibromyalgia.,"OBJECTIVE
To investigate the effects of a replacement diet with Khorasan wheat products in patients with fibromyalgia, in comparison with a similar replacement diet with control products made from organic semi-whole-grain modern wheat.
DESIGN
Randomized, double-blinded crossover trial.
SETTING
Outpatient clinic.
SUBJECTS
Twenty subjects (19 female and one male, mean age = 48.9 ± 12.3 years) with fibromyalgia.
METHODS
Participants were randomly assigned to consume either Khorasan or control wheat products (pasta, bread, crackers, biscuits) for eight weeks and then crossed. Validated self-administered questionnaires were collected from each subject at the beginning and end of each intervention period.
RESULTS
A general linear model for repeated measurement, adjusted for potential confounders, showed that the overall score reported from each questionnaire improved after both intervention and control periods, but the effect was more evident after the intervention with Khorasan. In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period. Similarly, FM Impact Questionnaire scores decreased significantly only after the Khorasan period, with a reduction that was significantly different between the intervention and control periods (-22.5% vs -0.3%, P = 0.037). The improvement was even greater in people with higher symptom severity.
CONCLUSIONS
A dietary intervention with Khorasan wheat products seems to benefit patients with fibromyalgia, especially those with greater symptom severity.",2020,"In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period.","['Twenty subjects (19 female and one male, mean age = 48.9 ± 12.3\u2009years) with fibromyalgia', 'patients with fibromyalgia, in comparison with a similar replacement diet with control products made from organic semi-whole-grain modern wheat', 'Patients with Fibromyalgia', 'Participants', 'Outpatient clinic']","['Khorasan or control wheat products (pasta, bread, crackers, biscuits', 'replacement diet with Khorasan wheat products', 'Khorasan Wheat-Based Replacement']","['FM Impact Questionnaire scores', 'Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ', 'Pain Symptoms and Quality of Life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0006138', 'cui_str': 'Bread'}, {'cui': 'C0452505', 'cui_str': 'Cracker'}, {'cui': 'C0452501', 'cui_str': 'Cookie and/or cracker'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3853226', 'cui_str': 'Khorasan wheat'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",20.0,0.0494743,"In particular, a statistically significant difference in Widespread Pain Index (WPI) + Severity Scale (SS) and Functional Outcome of Sleep Questionnaire (FOSQ) was observed, which decreased significantly by 21.5% and 11.7% respectively, only after the Khorasan period, while no statistically significant variations were reported after the control period.","[{'ForeName': 'Giuditta', 'Initials': 'G', 'LastName': 'Pagliai', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Colombini', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dinu', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Whittaker', 'Affiliation': 'Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Masoni', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Danza', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Amedeo', 'Initials': 'A', 'LastName': 'Amedei', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Ballerini', 'Affiliation': 'Multidisciplinary Center for Pain Therapy, Reference Center for Fibromyalgia, Piero Palagi Hospital, USL Toscana Centro, Florence, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Benedettelli', 'Affiliation': 'Department of Agrifood Production and Environmental Sciences, University of Florence, Florence, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sofi', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa134']
1086,32583295,Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.,"BACKGROUND AND OBJECTIVE
Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine.
METHODS
Patients requiring analgesia after bunionectomy or abdominoplasty were randomized to IV demand doses of placebo, oliceridine (0.1 mg, 0.35 mg, or 0.5 mg), or morphine (1 mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5 mg, morphine 4 mg, volume-matched placebo) with a 6-min lockout interval. Certified nurse anesthetists monitored each patient and withheld study medication according to the patient's respiratory status. For each patient, the duration of all DIs was summed and reported as CDDI. A zero-inflated gamma mixture model was used to compute the mean CDDI for each treatment.
RESULTS
Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%). The CDDI was also lower across all demand doses of oliceridine versus morphine.
CONCLUSION
Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.",2020,"RESULTS
Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","['Patients requiring analgesia after bunionectomy or abdominoplasty', 'Patients Treated for Acute Postoperative Pain']","['Oliceridine and Morphine', 'oliceridine', 'placebo, oliceridine', 'morphine (1\xa0mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5\xa0mg, morphine 4\xa0mg, volume-matched placebo', 'oliceridine and morphine', 'Oliceridine', 'morphine']","['respiratory safety', 'average cumulative duration of DI (CDDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.0289906,"RESULTS
Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","[{'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesiology, Cleveland Clinic, Outcomes Research, Anesthesiology Institute, Fairview Hospital, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. Saayad@ccf.org.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burt', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Clinical drug investigation,['10.1007/s40261-020-00936-0']
1087,32585668,Intensive Blood Pressure Lowering in Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage: Post Hoc Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH)-2 Trial.,"OBJECTIVE
To study the effect of intensive blood pressure reduction in patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial.
DESIGN
Randomized, multicenter, 2 group, open-label clinical trial.
SETTING
A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany.
PATIENTS
A total of 1,000 patients underwent randomization from May 2011 till September 2015.
INTERVENTIONS
We analyzed the effect of intensive (goal 110-139 mm Hg) over standard (goal 140-179 mm Hg) systolic blood pressure (SBP) reduction using intravenous nicardipine within 4.5 h of symptom onset in moderate to severe grade subjects with ICH in a non-prespecified analysis. Moderate to severe grade was defined by Glasgow Coma Scale score <13 or baseline National Institutes of Health Stroke Scale score ≥10 or baseline intraparenchymal hemorrhage volume ≥30 mL or presence of intraventricular hemorrhage. The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator.
MEASUREMENTS AND MAIN RESULTS
Of a total of 682 subjects who met the definition of moderate to severe grade (mean age 61.9 ± 13.1 years, 62.5% men) with a mean baseline SBP of 174.7 ± 24.8 mm Hg, the frequency of hematoma expansion was significantly lower among subjects randomized to intensive SBP reduction than among subjects randomized to standard SBP reduction (20.4 vs. 27.9%, relative risk [RR]: 0.7; 95% confidence interval [CI]: 0.55-0.96). The primary endpoint of death or disability was observed in 52.5% (170/324) of subjects receiving intensive SBP reduction and 48.9% (163/333) of subjects receiving standard SBP reduction (RR: 1.1; 95% CI: 0.9-1.2).
CONCLUSIONS
Intensive SBP lowering reduced the frequency of hematoma expansion but did not reduce the rate of death or disability in patients with moderate to severe grade ICH.",2020,"The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator.
","['patients with moderate to severe grade ICH', 'patients with moderate to severe intracerebral hemorrhage (ICH) within the subjects recruited in Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 trial', 'A total of 110 sites in the USA, Japan, China, Taiwan, South Korea, and Germany', 'Patients with Moderate to Severe Grade Acute Cerebral Hemorrhage', 'A total of 1,000 patients underwent randomization from May 2011 till September 2015', 'moderate to severe grade subjects with ICH in a non-prespecified analysis']","['intensive blood pressure reduction', 'nicardipine']","['frequency of hematoma expansion', 'Glasgow Coma Scale score', 'systolic blood pressure (SBP) reduction', 'rate of death or disability', 'standard SBP reduction', 'intensive SBP reduction', 'death or disability (score 4-6 on the modified Rankin scale', 'death or disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",1000.0,0.292665,"The primary outcome was death or disability (score 4-6 on the modified Rankin scale) at 3 months after randomization ascertained by a blinded investigator.
","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA, qureshai@gmail.com.'}, {'ForeName': 'Lydia D', 'Initials': 'LD', 'LastName': 'Foster', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Zeenet Qureshi Stroke Institute and Department of Neurology, University of Missouri, Columbia, Missouri, USA.'}, {'ForeName': 'Jose I', 'Initials': 'JI', 'LastName': 'Suarez', 'Affiliation': 'Neurosciences Critical Care, Departments of Anesthesiology and Critical Care Medicine, Neurology, and Neurosurgery, Johns Hopkins University School of Medicine Baltimore, Baltimore, Maryland, USA.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000506358']
1088,32592335,Treatment of oral lichen planus with mucoadhesive mycophenolate mofetil patch: A randomized clinical trial.,"OBJECTIVES
Oral lichen planus (OLP) is a chronic inflammatory disease of unknown etiology which is known as a premalignant disease. A complete cure has not been found for this condition. Mycophenolate mofetil (MMF) is a new drug that seems to be effective in improving OLP lesions. But there are no studies on the efficacy of mucoadhesive form of MMF in ulcerative OLP. Therefore, this study was performed to determine the therapeutic effect of MMF mucoadhesive on OLP lesions.
MATERIAL AND METHODS
Twenty-seven patients with OLP, were enrolled in two groups. All the patients were instructed to place the MMF 2% mucoadhesive on the lesion twice daily for 4 weeks. Lesion size was measured by a sterile digital caulis (mm) and the severity of burning sensation and pain by visual analogue scale (VAS; cm) at baseline and weekly follow-ups.
RESULTS
There was no significant difference in burning sensation and lesion size at Weeks 1, 2, and 3 in both groups. In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012). The difference in lesion size on control sides was not significant. In Group B, at Week 4, there was significant reduction in pain and burning sensation and lesion size (p = .004). No side effects were reported by the patients.
CONCLUSIONS
Based on the results, 2% MMF mucoadhesive was effective in decreasing burning sensation and pain severity and ulcer size of ulcerative OLP and the effect was time-dependent.",2020,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","['Twenty-seven patients with OLP, were enrolled in two groups']","['Mycophenolate mofetil (MMF', 'Oral lichen planus (OLP', 'MMF mucoadhesive', 'mucoadhesive mycophenolate mofetil patch']","['burning sensation and lesion size', 'lesion size on control sides', 'burning sensation and pain severity and ulcer size of ulcerative OLP', 'severity of burning sensation and pain by visual analogue scale (VAS; cm', 'Lesion size', 'pain and burning sensation and lesion size', 'side effects']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0449453', 'cui_str': 'Lesion size'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441987', 'cui_str': 'Side'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0206139', 'cui_str': 'Oral lichen planus'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",27.0,0.0435425,"In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012).","[{'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Samiee', 'Affiliation': 'Post Graduate Student of Oral and Maxillofacial Medicine, Oral and Maxillofacial Medicine Department, Mashhad Dental Faculty, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Taghavi Zenuz', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Mehdipour', 'Affiliation': 'Department of Oral and Maxillofacial Medicine, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Shokri', 'Affiliation': 'Department of Pharmaceutics, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Clinical and experimental dental research,['10.1002/cre2.302']
1089,32482392,Early Cardiac and Cerebral Hemodynamics with Umbilical Cord Milking Compared with Delayed Cord Clamping in Infants Born Preterm.,"OBJECTIVE
To evaluate changes in cerebral oxygenation, peripheral arterial oxygenation, respiratory status, and administered fraction of inspired oxygen during the first 10 minutes of life in premature infants receiving umbilical cord milking compared with delayed cord clamping (DCC).
STUDY DESIGN
Premature infants born at 23 0/7 to 27 6/7 weeks of gestation were randomized to umbilical cord milking or DCC. A near infrared spectroscopy sensor, pulse oximeter, and electrocardiogram electrodes were placed. Pulse rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and fraction of inspired oxygen were collected for 10 minutes in the delivery room. Longitudinal models were used to compare effects of umbilical cord milking and DCC.
RESULTS
Fifty-six infants had cerebral oximetry and advanced monitoring at birth. There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211). Longitudinal models suggested that peripheral oxygen saturation was higher in the umbilical cord milking group in the first 4 minutes (P = .0221) and that mean airway pressures were lower in the umbilical cord milking group after the first 7 minutes (P = .0072). No statistical differences were observed for fraction of inspired oxygen, cerebral tissue oxygenation, or heart rates.
CONCLUSIONS
The data suggest that the rapid transfer of blood during umbilical cord milking may facilitate lung expansion with improved pulmonary blood flow, but may also increase cerebral blood flow, resulting in severe intraventricular hemorrhage.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT03145142.",2020,There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211).,"['Infants Born Preterm', 'Fifty-six infants had cerebral oximetry and advanced monitoring at birth', 'premature infants receiving umbilical cord milking compared with delayed cord clamping (DCC', 'Premature infants born at 23 0/7 to 27 6/7 \xa0weeks of gestation']","['umbilical cord milking or DCC', 'Umbilical Cord Milking Compared with Delayed Cord Clamping']","['fraction of inspired oxygen, cerebral tissue oxygenation, or heart rates', 'mean airway pressures', 'cerebral oxygenation, peripheral arterial oxygenation, respiratory status, and administered fraction of inspired oxygen', 'peripheral oxygen saturation', 'cerebral blood flow', 'severe intraventricular hemorrhage', 'Pulse rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and fraction of inspired oxygen']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}]",56.0,0.151184,There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211).,"[{'ForeName': 'Anup C', 'Initials': 'AC', 'LastName': 'Katheria', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA. Electronic address: anup.katheria@sharp.com.'}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': 'Department of Biostatistics at the UAB School of Public Health, Birmingham, AL.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Essers', 'Affiliation': 'Department of Pediatrics University of Ulm, Ulm, Germany.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Mendler', 'Affiliation': 'Department of Pediatrics University of Ulm, Ulm, Germany.'}, {'ForeName': 'Eugene M', 'Initials': 'EM', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics and INFANT Centre, University College Cork, Ireland.'}, {'ForeName': 'Georg M', 'Initials': 'GM', 'LastName': 'Schmölzer', 'Affiliation': 'Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Arnell', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Wade D', 'Initials': 'WD', 'LastName': 'Rich', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Kasim', 'Initials': 'K', 'LastName': 'Hassen', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Allman', 'Affiliation': 'Department of Biostatistics at the UAB School of Public Health, Birmingham, AL.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': 'Department of Obstetrics and Gynecology, Salt Lake City, UT.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics at the UAB School of Public Health, Birmingham, AL.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Finer', 'Affiliation': 'Neonatal Research Institute, Sharp Mary Birch Hospital for Women & Newborns, San Diego, CA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.010']
1090,32487971,"Effects of Trunk Stabilization Exercise While Wearing a Pelvic Compression Belt on Walking and Balancing Abilities in Patients With Stroke: An Assessor Blinded, Preliminary, Randomized, Controlled Study.","OBJECTIVE
The aim of this study was to investigate the effects of wearing a pelvic compression belt during trunk stability exercise on balance and gait ability in patients with stroke.
DESIGN
Thirty-six patients with stroke participated and were randomly allocated to three groups: the paretic group (trunk stability exercise wearing a pelvic belt on the paretic side), the nonparetic group (trunk stability exercise wearing a pelvic belt on the nonparetic side), or the control group (trunk stability exercise without a pelvic belt). Walking and balancing abilities were assessed before and after trunk stabilization exercise.
RESULTS
Significantly larger gains were identified in the paretic group than in the control group for all variables (P < 0.017). In addition, significantly larger gains were observed in the paretic group than in the nonparetic group (P < 0.017) (limit of stability, 15.6%; stance phase of paretic side, 4.1%; 10-m walking test, -10.1%; 6-min walking test, 4.6%).
CONCLUSION
Wearing a pelvic belt on the paretic side during trunk stabilization exercise seems to be more effective at improving the balancing and walking abilities of patients with stroke than wearing a pelvic compression belt on the nonparetic side or not wearing a pelvic belt.",2020,Significantly larger gains were identified in the paretic group than in the control group for all variables (p < .017).,"['patients whit stroke', 'Thirty-six patients with stroke participated', 'patients with stroke']","['wearing a pelvic compression belt during trunk stability exercise', 'paretic group (trunk stability exercise wearing a pelvic belt on paretic side), the non-paretic group (trunk stability exercise wearing a pelvic belt on non-paretic side), or the control group (trunk stability exercise without a pelvic belt', 'trunk stabilization exercise']","['walking and balancing abilities', 'Walking and balancing abilities', 'larger gains', 'balance and gait ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319606', 'cui_str': '36'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",36.0,0.0276591,Significantly larger gains were identified in the paretic group than in the control group for all variables (p < .017).,"[{'ForeName': 'Yoon-Hee', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': 'From the Department of Physical Therapy, Graduate School of Daejeon University, Daejeon, Republic of Korea (Y-HC, N-HK); Department of Physical Therapy, College of Health and Medical Science, Cheongju University, Cheongju, Republic of Korea (S-MS); and Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Daejeon, Republic of Korea (Y-JC).'}, {'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sung-Min', 'Initials': 'SM', 'LastName': 'Son', 'Affiliation': ''}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001484']
1091,32488923,Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26-week PRONTO-T1D study.,"AIMS
To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26-week, treat-to-target, phase 3 trial.
MATERIALS AND METHODS
After an 8-week lead-in to optimize basal insulin glargine or degludec, patients were randomized to double-blind mealtime URLi (n = 451) or lispro (n = 442), or open-label post-meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non-inferiority margin 0.4%), with multiplicity-adjusted objectives for postprandial glucose (PPG) excursions after a meal test.
RESULTS
Both mealtime and post-meal URLi demonstrated non-inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi -0.08% [95% confidence interval (CI) -0.16, 0.00] and for post-meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post-meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1- and 2-hour PPG excursions during the meal test: ETD -1.55 mmol/L (95% CI -1.96, -1.14) at 1 hour and - 1.73 mmol/L (95% CI -2.28, -1.18) at 2 hours (both P < 0.001). The rate and incidence of severe, documented and postprandial hypoglycaemia (<3.0 mmol/L) was similar between treatments, but mealtime URLi demonstrated a 37% lower rate in the period >4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post-meal URLi, and 0.2% on lispro. Overall, the incidence of treatment-emergent adverse events was similar between treatments.
CONCLUSIONS
The results showed that URLi provided good glycaemic control, with non-inferiority to lispro confirmed for both mealtime and post-meal URLi, while superior PPG control was demonstrated with mealtime dosing.",2020,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","['adults with type 1 diabetes', 'Patients With Type 1 Diabetes']","['ultra rapid lispro (URLi) versus lispro', 'Ultra Rapid Lispro', 'double-blind mealtime URLi (n=451) or lispro (n=442), or open-label postmeal URLi', 'Lispro']","['Postprandial Glucose Control', 'incidence of treatment-emergent adverse events', 'rate and incidence of severe, documented and postprandial hypoglycaemia', 'Injection site reactions', 'postprandial glucose (PPG) excursions', '1- and 2-h PPG excursions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0271710', 'cui_str': 'Reactive hypoglycemia'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]",,0.0808552,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","[{'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Klaff', 'Affiliation': 'Rainier CRC, Renton, Washington, USA.'}, {'ForeName': 'Dachuang', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Tobian', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Junnosuke', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': ""Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Dahl', 'Affiliation': 'Gemeinschaftspraxis fur Innere Medizin und Diabetologie, Hamburg, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Lucas Research, Morehead City, North Carolina, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14100']
1092,32488989,Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors.,"The aim of this phase 1 study was to determine the effects of sapanisertib on the heart rate-corrected QT (QTc) interval in patients with advanced solid tumors. Adult patients with advanced solid tumors were enrolled to receive a single sapanisertib 40-mg dose. Blood samples for pharmacokinetic analysis were collected and electrocardiogram readings were recorded at baseline and up to 48 hours after dosing. Patients could continue to receive sapanisertib 30 mg once weekly in 28-day cycles for up to 12 months. The primary objective was to characterize the effect of a single dose of sapanisertib (40 mg) on the QT interval. Secondary objectives were to evaluate safety, tolerability, and pharmacokinetics. Following a single sapanisertib 40-mg dose in 44 patients, the maximum least squares mean (upper bound of 1-sided 95% confidence interval) changes from time-matched baseline were 7.1 milliseconds (11.4 milliseconds) for individual rate-corrected QT interval at 24 hours after dosing, and 1.8 milliseconds (5.6 milliseconds) for Fridericia-corrected QTc at 1 hour post-dose. There was no sapanisertib plasma concentration-dependent increase in the change from time-matched baseline individual rate-corrected QTc interval or Fridericia-corrected QTc. The most common adverse events following sapanisertib 30 mg once-weekly dosing were nausea (80%), fatigue (61%), vomiting (57%), and decreased appetite (45%). A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors. The safety profile of sapanisertib 30 mg once weekly was favorable, and no new safety signals were observed (NCT02197572, clinicaltrials.gov).",2020,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"['Adult patients with advanced solid tumors', 'Patients With Advanced Solid Tumors', 'patients with advanced solid tumors']",['sapanisertib'],"['QTc interval', 'fatigue', 'safety, tolerability, and pharmacokinetics', 'sapanisertib plasma concentration', 'appetite', 'vomiting', 'nausea', 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]",[],"[{'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.278022,A single sapanisertib 40 mg dose did not produce clinically relevant effects on QTc interval in patients with advanced solid tumors.,"[{'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Patel', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Goel', 'Affiliation': 'Montefiore Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Manish R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Florida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, Florida, USA.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Rangachari', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jayson D', 'Initials': 'JD', 'LastName': 'Wilbur', 'Affiliation': 'Metrum Research Group, LCC, Connecticut, USA.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Shou', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.'}, {'ForeName': 'A Craig', 'Initials': 'AC', 'LastName': 'Lockhart', 'Affiliation': 'Sylvester Comprehensive Cancer Center, Miller School of Medicine, University of Miami, Miami, Florida, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.808']
1093,32683644,"Efficacy and Safety of Intravenously Administered Tramadol in Patients with Moderate to Severe Pain Following Bunionectomy: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study.","INTRODUCTION
This study is part of the registrational program for intravenously administered (IV) tramadol in the USA and compared the analgesic benefit and tolerability of two doses of IV tramadol (50 mg and 25 mg) to placebo in adult patients undergoing bunionectomy, an orthopedic surgical model.
METHODS
This was a phase 3, multicenter, double-blind, three-arm, randomized, placebo-controlled, multiple-dose, parallel-group trial to evaluate IV tramadol in the management of postoperative pain following bunionectomy. Eligible patients were randomized (1:1:1 ratio) to IV tramadol 50 mg, 25 mg, or placebo. Primary endpoint was summary of pain intensity differences over 48 h (SPID48). Key secondary endpoints included SPID24, total consumption of rescue analgesia, and patient global assessment of efficacy (PGA). Safety assessments included treatment emergent adverse events (TEAEs), clinical laboratory tests, vital signs, and electrocardiograms (ECGs). Assessment of the dose-response was an important objective of the study.
RESULTS
The study established a dose response, with IV tramadol 50 mg demonstrating statistically significant benefit (p < 0.05) over placebo for primary and all key secondary efficacy endpoints, whereas tramadol 25 mg demonstrated intermediate results between the 50 mg and placebo arms. IV tramadol 50 mg was well tolerated; most common TEAEs were nausea and vomiting; and there were no meaningful differences among treatments for vital signs, ECG, and laboratory assessments. The largest proportion of patients completed tramadol 50 mg (98.6%) compared to tramadol 25 mg (91.8%) and placebo (88.2%).
CONCLUSION
IV tramadol 50 mg was effective and well tolerated as treatment for postoperative pain following bunionectomy surgery, while IV tramadol 25 mg, although well tolerated, was judged an ineffective dose for the treatment of pain in this setting. IV tramadol 50 mg was further developed in the registrational program for the USA.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03290378.",2020,"mg was well tolerated; most common TEAEs were nausea and vomiting; and there were no meaningful differences among treatments for vital signs, ECG, and laboratory assessments.","['adult patients undergoing bunionectomy, an orthopedic surgical model', 'Eligible patients', 'Patients with Moderate to Severe Pain', 'postoperative pain following bunionectomy']","['Bunionectomy', 'Placebo', 'IV tramadol', 'Tramadol', 'tramadol', 'tramadol 50\xa0mg, 25\xa0mg, or placebo', 'placebo']","['Efficacy and Safety', 'nausea and vomiting', 'treatment emergent adverse events (TEAEs), clinical laboratory tests, vital signs, and electrocardiograms (ECGs', 'SPID24, total consumption of rescue analgesia, and patient global assessment of efficacy (PGA', 'effective and well tolerated', 'pain intensity differences over 48\xa0h (SPID48']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0887962', 'cui_str': 'Models, Surgical'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]","[{'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.495008,"mg was well tolerated; most common TEAEs were nausea and vomiting; and there were no meaningful differences among treatments for vital signs, ECG, and laboratory assessments.","[{'ForeName': 'Neil K', 'Initials': 'NK', 'LastName': 'Singla', 'Affiliation': 'Lotus Clinical Research, Pasadena, CA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pollak', 'Affiliation': 'Evolution Research Group, New Providence, NJ, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gottlieb', 'Affiliation': 'Chesapeake Research Group, Pasadena, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'HD Research, Bellaire, TX, USA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'HD Research, Bellaire, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zimmerman', 'Affiliation': 'Trovare Clinical Research, Bakersfield, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harnett', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA. llu@avenuetx.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reines', 'Affiliation': 'Avenue Therapeutics, New York, NY, USA.'}]",Pain and therapy,['10.1007/s40122-020-00184-2']
1094,32454218,Safety of leadless pacemaker implantation in the very elderly.,"BACKGROUND
The Micra leadless pacemaker (MLP) has proven to be an effective alternative to a traditional transvenous pacemaker (TVP). However, there has been concern about using the MLP in frail elderly patients because of the size of the implant sheath and perceived risk of perforation.
OBJECTIVES
The objectives of this study were to report the safety of the MLP and compare MPLs with TVPs in the very elderly.
METHODS
All patients 85 years and older who received an MLP or a single-chamber TVP across 6 hospitals in the Northwell Health system from December 2015 to November 2019 were included. Demographic characteristics, procedural details, and procedure-related complications were reviewed.
RESULTS
Over 4 years, 564 patients underwent MLP implantation. During this time, 183 MLPs and 119 TVPs were implanted in patients 85 years and older. The mean age was 89.7 ± 3.4 years, and 47.4% were men. MLP implantation was successful in all but 3 patients (98.4% success rate). There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276). Complications included 5 (2.7%) access site hematomas in the MLP group, 3 (2.5%) in the TVP group, 1 (0.5 vs 0.8%) pericardial effusion in each group, and 3 (2.5%) acute lead dislodgments (<24 hours) in the TVP group. MLP implantation resulted in a significantly shorter mean procedure time (35.7 ± 23.0 minutes vs 62.3 ± 31.5 minutes, P < .001).
CONCLUSION
In a large multicenter study of patients 85 years and older, MLP implantation (1) was successful in 98.4% of patients, (2) was safe with no difference in procedure-related complications compared to the TVP group, and (3) resulted in significantly shorter procedure times.",2020,There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276).,"['patients 85 years and older, MLP implantation (1', 'across 6 hospitals in the Northwell Health system from December 2015 to November 2019 were included', 'All patients 85 years and older who received an', 'frail elderly patients', 'The mean age was 89.7 ± 3.4 years, and 47.4% were men', '564 patients underwent MLP implantation', 'patients 85 years and older']","['leadless pacemaker implantation', 'MLP implantation', 'MLP', 'MLP or a single-chamber TVP']","['mean procedure time', 'procedure-related complications', 'shorter procedure times']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0336574', 'cui_str': 'Cardiac transvenous pacemaker'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.0862507,There was no difference in procedure-related complications (3.3% vs 5.9%; P = .276).,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pagan', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York. Electronic address: eapagan13@gmail.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gabriels', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Khodak', 'Affiliation': 'Department of Medicine, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chang', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Beldner', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Laurence M', 'Initials': 'LM', 'LastName': 'Epstein', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Willner', 'Affiliation': 'Division of Electrophysiology, North Shore University Hospital, Northwell Health, Manhasset, New York.'}]",Heart rhythm,['10.1016/j.hrthm.2020.05.022']
1095,32592516,A Randomized Sham-Controlled Cross-Over Study on the Short-Term Effect of Non-Invasive Cervical Vagus Nerve Stimulation on Spinal and Supraspinal Nociception in Healthy Subjects.,"OBJECTIVE
The aim of the present study was to test the effects of vagus nerve stimulation (VNS) on the descending pain inhibition, quantified by the nociceptive flexor (RIII) reflex and the conditioned pain modulation (CPM) paradigm, and on supraspinal nociceptive responses, assessed by pain intensity and unpleasantness ratings and late somatosensory evoked potentials (SEPs), in healthy subjects.
BACKGROUND
Non-invasive vagus nerve stimulation (nVNS) showed promising effects on headache and pain treatment. Underlying mechanisms are only incompletely understood but may include the activation of the descending pain inhibitory system and/or the modification of emotional responses to pain.
METHODS
Twenty-seven adult, healthy, and pain-free subjects participated in this double-blind cross-over study conducted at a university research center. They received 4 minutes of cervical nVNS or sham stimulation in randomized order. RIII reflexes, pain ratings, and SEPs were assessed before, during, and 5, 15, 30, and 60 minutes after nVNS/sham stimulation, followed by CPM testing. The primary outcome was the nVNS effect on the RIII reflex size. Three subjects were excluded after the preparatory session (before randomization), 1 subject was excluded after outlier analysis, leaving 23 for analysis.
RESULTS
RIII reflex areas were 917.1 ± 563.8 µV × ms (mean ± SD) before, 952.4 ± 467.4 µV × ms during and 929.2 ± 484.0 µV × ms immediately after nVNS and 858.4 ± 489.2 µV × ms before, 913.9 ± 539.7 µV × ms during and 862.4 ± 476.0 µV × ms after sham stimulation, revealing no differences between the immediate effects of nVNS and sham stimulation (F [3,66] = 0.67, P = .574). There also were no effects of nVNS over sham on RIII reflex areas up to 60 minutes after nVNS (F [1.7,37.4] = 1.29, P = .283). Similarly, there was no statistically significant effect of nVNS on pain intensity ratings and thresholds, RIII reflex thresholds, late SEP amplitudes, and the CPM effect, compared to sham. Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F [1,22] = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation).
CONCLUSIONS
The present study does not support an acute effect of nVNS on descending pain inhibition, pain intensity perception or supraspinal nociception in healthy adults. However, there was a small effect on pain unpleasantness during nVNS, suggesting that nVNS may preferentially act on affective, not somatosensory pain components.",2020,"Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F [1,22] = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation).
","['RIII reflex areas were 917.1\xa0±\xa0563.8', '476.0', 'healthy subjects', 'Twenty-seven adult, healthy, and pain-free subjects participated in this double-blind cross-over study conducted at a university research center', 'healthy adults', 'Healthy Subjects']","['Non-Invasive Cervical Vagus Nerve Stimulation', 'vagus nerve stimulation (VNS', 'nVNS', 'Non-invasive vagus nerve stimulation (nVNS', 'cervical nVNS or sham stimulation']","['nVNS effect on the RIII reflex size', 'headache and pain treatment', 'Spinal and Supraspinal Nociception', 'RIII reflexes, pain ratings, and SEPs', 'Pain unpleasantness ratings', 'pain intensity ratings and thresholds, RIII reflex thresholds, late SEP amplitudes, and the CPM effect', 'pain unpleasantness', 'pain intensity and unpleasantness ratings and late somatosensory evoked potentials (SEPs', 'RIII reflex areas', 'mean\xa0±\xa0SD', 'nociceptive flexor (RIII) reflex and the conditioned pain modulation (CPM']","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0277847', 'cui_str': 'Flexion spinal defense reflex'}]",3.0,0.21542,"Pain unpleasantness ratings statistically significantly decreased from 4.4 ± 2.4 (NRS 0-10) to 4.1 ± 2.5 during nVNS compared to sham stimulation (F [1,22] = 8.74, P = .007), but there were no longer lasting effects (5-60 minutes after stimulation).
","[{'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Alt', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Wach', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Liebler', 'Affiliation': 'electroCore, Inc., Basking Ridge, NJ, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Straube', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ruscheweyh', 'Affiliation': 'Department of Neurology, University of Munich, Munich, Germany.'}]",Headache,['10.1111/head.13891']
1096,32593123,Quality of life changes in response to yoga therapy in patients with schizophrenia: Reanalysis of Three randomized controlled trials.,,2020,,['patients with schizophrenia'],['yoga therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.0595902,,"[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Ikai-Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, M5S 2W6, Toronto, ON, Canada. Electronic address: sako0609@gmail.com.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Kimel Family Translational Imaging-Genetics Laboratory, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Geriatric Mental Health Program, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102250']
1097,31834239,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND
ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population.
METHODS
Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications.
RESULTS
The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group.
CONCLUSIONS
There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients.
LEVEL OF EVIDENCE
Level I.",2019,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480']
1098,32488263,Efficacy and Safety of Two Fixed-Dose Combinations of Tramadol Hydrochloride and Diclofenac Sodium in Postoperative Dental Pain.,"OBJECTIVE
To evaluate the analgesic efficacy and safety of tramadol hydrochloride/diclofenac sodium fixed-dose combination 25 mg/25 mg (FDC 25/25) and 50 mg/50 mg (FDC 50/50) vs tramadol 50 mg (T50) and diclofenac 50 mg (D50) monotherapies in acute postoperative dental pain.
SETTING
Eight sites across Mexico.
SUBJECTS
Adults (N = 829) with moderate to severe pain after third molar extraction.
DESIGN
Prospective, randomized, double-blind, diclofenac- and tramadol-controlled, parallel-group, noninferiority, phase 3 trial.
METHODS
Subjects were randomized to receive three doses (one every eight hours) of oral FDC 25/25, FDC 50/50, T50, or D50 over a 24-hour period. Pain intensity and pain relief were evaluated frequently over the 24 hours postdose. Secondary measures included peak pain relief, onset, and duration of effect. The primary objective was to compare the analgesic efficacy and safety of FDC 50/50 or analgesic noninferiority of FDC 25/25 vs D50 or T50. The primary efficacy end point was total pain relief over four hours after dose 1 (TOTPAR4).
RESULTS
TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components. All secondary efficacy measures supported these results. The safety profile of FDC 25/25 and FDC 50/50 was consistent with the known safety profile of D50 and T50 monotherapies, with no unexpected safety findings observed.
CONCLUSIONS
Tramadol/diclofenac FDC 25/25 and FDC 50/50 provide superior analgesia for acute pain after third molar extraction than either of the individual components. Minor adverse effects appeared to be related to the higher doses of tramadol.",2020,"RESULTS
TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components.","['acute postoperative dental pain', 'Adults (N\u2009=\u2009829) with moderate to severe pain after third molar extraction', 'Subjects', 'Eight sites across Mexico']","['tramadol 50\u2009mg (T50) and diclofenac 50\u2009mg (D50) monotherapies', 'oral FDC 25/25, FDC 50/50, T50, or D50 over a 24-hour period', 'diclofenac- and tramadol', 'tramadol hydrochloride/diclofenac sodium fixed-dose combination 25\u2009mg/25\u2009mg (FDC 25/25) and 50\u2009mg/50\u2009mg (FDC 50/50', 'FDC', 'tramadol', 'Tramadol/diclofenac FDC', 'Tramadol Hydrochloride and Diclofenac Sodium']","['Postoperative Dental Pain', 'Efficacy and Safety', 'Pain intensity and pain relief', 'analgesic efficacy and safety', 'peak pain relief, onset, and duration of effect', 'TOTPAR4 scores', 'total pain relief']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0340427', 'cui_str': 'Primary familial dilated cardiomyopathy'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C2350089', 'cui_str': 'Tramadol hydrochloride'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",829.0,0.338081,"RESULTS
TOTPAR4 scores showed that FDC 25/25 was noninferior (P < 0.0001, delta = 1.5) and FDC 50/50 was superior (P < 0.0001) to the individual components.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Desjardins', 'Affiliation': 'Desjardins Associates, LLC, Maplewood, New Jersey.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Alvarado', 'Affiliation': 'ECI-Estudios Clínicos Internacionales, Puebla, México.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Gil', 'Affiliation': 'Eukarya Pharmasite S.C., Monterrey, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Instituto de Investigación del Hospital Cardiológica, Aguascalientes, México.'}, {'ForeName': 'Rogelio', 'Initials': 'R', 'LastName': 'Guajardo', 'Affiliation': 'Centro de Investigación Farmacológica del Bajío, S.C., León, Guanajuato, México.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa124']
1099,32588515,Biochemical control of the combination of cyclooxygenase-2 inhibitor and 125 I-brachytherapy for prostate cancer: Post hoc analysis of an open-label controlled randomized trial.,"OBJECTIVES
To evaluate the use of cyclooxygenase-2 inhibitors in patients receiving low-dose-rate brachytherapy for prostate cancer.
METHODS
A total of 310 patients with prostate cancer (cT1c-3aN0M0) who received low-dose-rate brachytherapy between May 2010 and July 2013 were enrolled and allocated to one of the two treatment groups (tamsulosin alone 0.2 mg/day for 6 months vs tamsulosin 0.2 mg/day for 6 months plus celecoxib 200 mg/day for 3 months). The primary end-point was the chronological change in international prostate symptom score, and the number of patients was assessed for the primary end-point. Biochemical recurrence-free, cancer-specific survival and overall survival rates 5 years after the last patient received low-dose-rate brachytherapy were retrospectively examined.
RESULTS
The median follow-up period after low-dose-rate brachytherapy was 72.0 months (range 3-99 months). A total of 12 (3.9%) patients experienced biochemical recurrence. The biochemical recurrence-free rate in the celecoxib group (5-year biochemical recurrence-free rate 98.5%) was significantly better (log-rank test P = 0.023, 95% confidence interval 0.07-0.63, hazard ratio 0.20) than that in the tamsulosin group (5-year biochemical recurrence-free rate 93.4%). None of the patients died from prostate cancer. However, 14 (4.5%) patients died of other causes. No significant difference was observed in terms of overall survival between the celecoxib and tamsulosin groups.
CONCLUSIONS
The combination of cyclooxygenase-2 inhibitor and low-dose-rate brachytherapy can contribute to a better biochemical control of prostate cancer.",2020,"Biochemical recurrence-free, cancer-specific survival and overall survival rates","['patients receiving low-dose-rate brachytherapy for prostate cancer', '310 patients with prostate cancer (cT1c-3aN0M0) who received low-dose-rate brachytherapy between May 2010 and July 2013', 'prostate cancer']","['tamsulosin', 'cyclooxygenase-2 inhibitors', 'low-dose-rate brachytherapy', 'cyclooxygenase-2 inhibitor and low-dose-rate brachytherapy', 'cyclooxygenase-2 inhibitor and 125 I-brachytherapy', 'tamsulosin alone 0.2\xa0mg/day for 6\xa0months vs tamsulosin 0.2\xa0mg/day for 6\xa0months plus celecoxib', 'celecoxib']","['biochemical recurrence', 'overall survival', 'biochemical recurrence-free rate', 'chronological change in international prostate symptom score', 'Biochemical recurrence-free, cancer-specific survival and overall survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C5191352', 'cui_str': '310'}]","[{'cui': 'C0257343', 'cui_str': 'tamsulosin'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0454271', 'cui_str': 'Low dose rate brachytherapy'}, {'cui': 'C0796396', 'cui_str': 'Iodine-125'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",310.0,0.124329,"Biochemical recurrence-free, cancer-specific survival and overall survival rates","[{'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Nakai', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Nobumichi', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Asakawa', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Anai', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Makito', 'Initials': 'M', 'LastName': 'Miyake', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Morizawa', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Shunta', 'Initials': 'S', 'LastName': 'Hori', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Owari', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of, Diagnostic Pathology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Chiho', 'Initials': 'C', 'LastName': 'Ohbayashi', 'Affiliation': 'Department of, Diagnostic Pathology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Yamaki', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Hasegawa', 'Affiliation': 'Department of, Radiation Oncology, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Kiyohide', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Departments of, Department of, Urology, Nara Medical University, Kashihara, Nara, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14294']
1100,32600626,Depressive symptoms as a moderator of college student response to computerized alcohol intervention.,"BACKGROUND
Personalized normative alcohol feedback (PNF) is associated with decreased alcohol use among young adults. However, limited research has examined the influence of depressive symptoms on PNF efficacy. This study examined symptoms of depression as a moderator of college student response to a computerized PNF intervention for alcohol use.
METHODS
College students (N = 212, 59% female) who reported drinking in a typical week completed baseline and one-month assessments as part of a previously published intervention trial. We randomized participants to alcohol PNF (n = 153) or assessment only (n = 59). We used regression models to examine the interaction between PNF and symptoms of depression on alcohol outcomes at one-month follow-up.
RESULTS
One in four participants screened positive for clinically significant symptoms of depression. Depressive symptoms did not moderate intervention effects on drinking quantity. However, PNF was only associated with reduced frequency of heavy episodic drinking and lower probability of any alcohol-related consequence in the context of mild to moderate (not minimal) symptoms of depression.
CONCLUSIONS
PNF is more effective than assessment alone in reducing drinking quantity, regardless of symptoms of depression. However, it may only be more effective in decreasing frequency of heavy episodic drinking and the probability of alcohol-related consequences among those experiencing mild to moderate (as opposed to minimal) symptoms of depression. Alcohol intervention trials should assess symptoms of depression and consider them in data analysis.",2020,"However, PNF was only associated with reduced frequency of heavy episodic drinking and lower probability of any alcohol-related consequence in the context of mild to moderate (not minimal) symptoms of depression.
","['n\xa0=\xa0153) or assessment only (n\xa0=\xa059', 'College students (N\xa0=\xa0212, 59% female) who reported drinking in a typical week completed baseline and one-month assessments as part of a previously published intervention trial', 'young adults']","['Personalized normative alcohol feedback (PNF', 'Alcohol intervention', 'computerized PNF intervention', 'computerized alcohol intervention', 'PNF', 'alcohol PNF']","['drinking quantity', 'frequency of heavy episodic drinking', 'Depressive symptoms']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.025499,"However, PNF was only associated with reduced frequency of heavy episodic drinking and lower probability of any alcohol-related consequence in the context of mild to moderate (not minimal) symptoms of depression.
","[{'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA. Electronic address: millmary@health.missouri.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Department of Psychology, City University of New York, Brooklyn College, 2900 Bedford Ave, Brooklyn, NY 11210, USA.'}, {'ForeName': 'Chan Jeong', 'Initials': 'CJ', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Wisconsin - Stevens Point, Science Building, Stevens Point, WI 54481, USA.'}, {'ForeName': 'Eleanor L S', 'Initials': 'ELS', 'LastName': 'Leavens', 'Affiliation': 'Department of Psychology, Oklahoma State University, 116 North Murray, Stillwater, OK 74078, USA.'}, {'ForeName': 'Thad R', 'Initials': 'TR', 'LastName': 'Leffingwell', 'Affiliation': 'Department of Psychology, Oklahoma State University, 116 North Murray, Stillwater, OK 74078, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108038']
1101,32583567,The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial.,"OBJECTIVES
Exploring the efficacy and safety of perioperative chemotherapy on patients with AGC at different clinical and pathological stages.
METHODS
A phase III randomized, multicenter, trial comparing adjuvant (arm A) or perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin (XELOX, arm C) was initiated in T3/4, node + gastric cancer patients (unclear). Each patient received an 8-cycle chemotherapy (3 weeks for one cycle). Group arms B and C received two cycles preoperatively, and six cycles postoperatively. Primary endpoints were R0 resection rate and DFS, and secondary endpoints included OS, ORR, DCR, and safety. This study was registered on Clinicaltrials.gov. NCT01516944.
RESULTS
A total of 749 patients were randomly assigned into groups A, B, and C. Group A received 1460 circles chemotherapy and group B received 1177 circles while group C received 1200 circles. R0 resection rates in the three groups were 81.7%, 88.7%, and 83.1%, respectively. The difference between groups A and B was considered to be statistically significant (P = .018), and no significant difference between groups B and C (P = .051). Hazard ratio were compared between groups B and C and DFS showed 0.72 (0.67-0.77 with 95% CI), P non-inferiority < .0001, P log-rank = .064). The CI top limit actually lower than the estimated value of 1.38, which indicated noninferiority of SOX to XELOX.
CONCLUSIONS
Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates. This study was powered to show superiority of perioperative over adjuvant SOX, and noninferiority of SOX to XELOX. Volume measurement, repeated laparoscopic exploration combined with exfoliative cytology can be used as a supplementary method in the clinical staging and efficacy evaluation of AGC.",2020,"Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates.","['749 patients', 'T3/4, node\xa0+\xa0gastric cancer patients (unclear', 'patients with advanced gastric cancer', 'patients with AGC at different clinical\xa0and pathological stages']","['PAC, perioperative chemotherapy', '1460 circles chemotherapy', '8-cycle chemotherapy', 'perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin (XELOX, arm C', 'laparoscopic exploration combined with exfoliative cytology', 'perioperative chemotherapy', 'neoadjuvant chemotherapy']","['R0 resection rates', 'R0 resection rate and DFS, and secondary endpoints included OS, ORR, DCR, and safety', 'efficacy and safety', 'R0 resection rates and prognosis', 'Hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205226', 'cui_str': 'Exfoliative'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",749.0,0.161197,"Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates.","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Lian', 'Affiliation': 'Surgical Oncology, Changzhi Medical College Affiliated Peace Hospital, Changzhi, Shanxi, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Huo', 'Affiliation': ""Gastrointestinal Tumor Surgery, Xingtai People's Hospital, Xingtai, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'General Surgery, The First Hospital of Shijiazhuang, Shijiazhuang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Liqiao', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Bibo', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Zhidong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Honghai', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Peigang', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Cancer medicine,['10.1002/cam4.3224']
1102,32589056,"Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.","IMPACT-AFib was an 80,000-patient randomized clinical trial implemented by five US insurance companies (health plans) aimed at increasing the use of oral anticoagulants by individuals with atrial fibrillation who were at high risk of stroke and not on treatment. The underlying thesis was that patients could be change agents to initiate prescribing discussions with their providers. We tested the effect of mailing information to both patients and their providers. We used administrative medical claims and pharmacy dispensing data to identify eligible patients, to randomize them to an early or delayed intervention, and to assess clinical outcomes. The core data were analysis-ready datasets each site had created and curated for the FDA's Sentinel System, supplemented by updated ""fresh"" pharmacy and enrollment data to ensure eligibility at the time of intervention. Following mutually agreed upon procedures, sites linked to additional internal source data to implement the intervention-educational information mailed to patients and their providers in the early intervention arm, and to providers of patients in the delayed intervention arm approximately 12 months later. The primary analysis compares the early intervention arm to the delayed intervention arm, prior to the delayed intervention being conducted (i.e. compares intervention to non-intervention). The endpoints of interest were evidence of initiation of anticoagulation (primary) as well as clinical endpoints, including stroke and hospitalization for bleeding. Major challenges, some unanticipated, identified during the planning phase include convening multi-stakeholder investigator teams and advisors, addressing ethical concerns about not intervening in a usual care comparison group, and identifying and avoiding interference with sites' routine programs that were similar to the intervention. Needs and challenges during the implementation phase included the fact that even limited site-specific programming greatly increased time and effort, the need to refresh research data extracts immediately before outreach to patients and providers, potential difficulty identifying low-cost medications such as warfarin that may not be reimbursed by health plans and so not discoverable in dispensing data, the need to develop workarounds when ""providers"" in claims data were facilities, difficulty addressing clustering of patients by provider because providers can have multiple identifiers within and between health plans, and the need to anticipate loss to follow up because of health plan disenrollment or change in benefits. As pragmatic trials begin to shape evidence generation within clinical practice, investigators should anticipate issues inherent to claims data and working with multiple large sites. In IMPACT-AFib, we found that investing in collaboration and communication among all parties throughout all phases of the study helped ensure common understanding, early identification of challenges, and streamlined actual implementation.",2020,"Major challenges, some unanticipated, identified during the planning phase include convening multi-stakeholder investigator teams and advisors, addressing ethical concerns about not intervening in a usual care comparison group, and identifying and avoiding interference with sites' routine programs that were similar to the intervention.",['individuals with atrial fibrillation who were at high risk of stroke and not on treatment'],[],"['initiation of anticoagulation (primary) as well as clinical endpoints, including stroke and hospitalization for bleeding']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",,0.037705,"Major challenges, some unanticipated, identified during the planning phase include convening multi-stakeholder investigator teams and advisors, addressing ethical concerns about not intervening in a usual care comparison group, and identifying and avoiding interference with sites' routine programs that were similar to the intervention.","[{'ForeName': 'Crystal J', 'Initials': 'CJ', 'LastName': 'Garcia', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'HealthCore, Inc., Wilmington, DE, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Lin', 'Affiliation': 'OptumInsight Life Sciences, Inc., Boston, MA, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'McMahill-Walraven', 'Affiliation': 'Aetna Inc., a CVS Health Company, Blue Bell, PA, USA.'}, {'ForeName': 'Vinit', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Humana Healthcare Research, Humana Inc., Louisville, KY, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Parlett', 'Affiliation': 'HealthCore, Inc., Wilmington, DE, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'U.S. Food and Drug Administration, Silver Spring, MD, USA.'}, {'ForeName': 'Hussein R', 'Initials': 'HR', 'LastName': 'Al-Khalidi', 'Affiliation': 'Department of Biostatistics and Bioinformatics and Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Debbe', 'Initials': 'D', 'LastName': 'McCall', 'Affiliation': 'Rowan Tree Perspectives Consulting, Murrieta, CA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Platt', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Noelle M', 'Initials': 'NM', 'LastName': 'Cocoros', 'Affiliation': 'Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520928426']
1103,32590520,"Radiographical Comparison of Superior and Inferior Gluteal Vessels in ""Jackknife"" Versus Prone Positions: A Prospective, Self-Controlled Trial.","BACKGROUND
Mortality after gluteal augmentation with fat transfer techniques is extremely high. Placement of fat subcutaneously versus in the gluteal musculature, or both, are considerably debated. The purpose of this study was to radiographically show the anatomical difference in live subjects in different procedural positions: the flexed or ""Jack-knife"" versus prone positions.
METHODS
A total of ten females underwent Computerized Tomography (CT) scanning of the pelvis with venous phase run-off in both the ""Jack-knife"" and prone positions. A CT specialized radiologist then reviewed images and measured distances from the inferior and superior gluteal veins (IGV and SGV, respectively) to the skin and muscle. Three-dimensional (3D) imaging and analysis were also performed.
RESULTS
Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions. 3D modeling showed a significant reduction in the volume and SGV and IGV diameters when in the ""Jack-knife"" position.
CONCLUSIONS
When placed in the ""Jack-knife"" position for gluteal augmentation with fat transfer, extreme caution should be taken with the injecting cannula as the underlying muscle is only 2-3 centimeters deep. 3D analysis showed narrowed and reduced volume of gluteal vasculature when in the ""Jack-knife"" position; a possible indication of torsion or stretch on the vessel around the pelvic rim that could cause vein avulsion injury from the pressurized fat within the piriform space.",2020,"RESULTS
Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","['Jackknife"" Versus Prone Positions']","['Computerized Tomography (CT) scanning', 'flexed or ""Jack-knife"" versus prone positions']","['volume of gluteal vasculature', 'volume and SGV and IGV diameters']","[{'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}]",10.0,0.0267786,"RESULTS
Measurements were significantly shorter with respect to distance from skin to muscle, skin to vessel, and vessel to muscle observed from IGV and SGV in the ""Jack-knife"" versus the prone positions.","[{'ForeName': 'Connor W', 'Initials': 'CW', 'LastName': 'Barnes', 'Affiliation': ''}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'Rajendra P', 'Initials': 'RP', 'LastName': 'Kedar', 'Affiliation': ''}, {'ForeName': 'Thanh Q', 'Initials': 'TQ', 'LastName': 'Tran', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Karlnoski', 'Affiliation': ''}, {'ForeName': 'Summer J', 'Initials': 'SJ', 'LastName': 'Decker', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Smith', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007151']
1104,32597673,The future is now: Age-progressed images motivate community college students to prepare for their financial futures.,"Part of the challenge young people face when preparing for lifelong financial security is visualizing the far-off future. Age-progression technology has been shown to motivate young people to save for retirement. The current study applied age progression for motivating socioeconomically diverse community college students as part of a college planning course. We recruited 106 students enrolled in a mandatory ""Transitioning to College"" course and randomly assigned them to view age-progressed or same-aged digital avatars. Compared to controls, age-progressed participants gave more correct answers and exhibited higher confidence (i.e., fewer ""don't know"" responses) on a financial literacy test. Confidence mediated the effect of age progression on correct responses, but not the other way around, pointing to financial confidence as a precursor to effective financial education. Students also reported interest in attending more long-term financial planning workshops (e.g., investing and retirement) available through their college. No differences were observed in financial planning for the near term (e.g., student aid and credit cards). The current study demonstrates the viability of age progression as a practical, inexpensive, and scalable intervention. Findings also illustrate the significance of this intervention for reducing pervasive socioeconomic and age disparities in financial knowledge and enhancing long-term financial prospects across future generations. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"No differences were observed in financial planning for the near term (e.g., student aid and credit cards).","['motivating socioeconomically diverse community college students', '106 students enrolled in a mandatory ""Transitioning to College"" course and randomly assigned them to view age-progressed or same-aged digital avatars']",[],['financial planning'],"[{'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",106.0,0.0189586,"No differences were observed in financial planning for the near term (e.g., student aid and credit cards).","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sims', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Raposo', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jeremy N', 'Initials': 'JN', 'LastName': 'Bailenson', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Carstensen', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000275']
1105,32594789,"Mindfulness, Education, and Exercise for age-related cognitive decline: Study protocol, pilot study results, and description of the baseline sample.","BACKGROUND/AIMS
Age-related cognitive decline is a pervasive problem in our aging population. To date, no pharmacological treatments to halt or reverse cognitive decline are available. Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction, may reduce or reverse cognitive decline, but rigorously designed randomized controlled trials are needed to test the efficacy of such interventions.
METHODS
Here, we describe the design of the Mindfulness, Education, and Exercise study, an 18-month randomized controlled trial that will assess the effect of two interventions-mindfulness training plus moderate-to-vigorous intensity exercise or moderate-to-vigorous intensity exercise alone-compared with a health education control group on cognitive function in older adults. An extensive battery of biobehavioral assessments will be used to understand the mechanisms of cognitive remediation, by using structural and resting state functional magnetic resonance imaging, insulin sensitivity, inflammation, and metabolic and behavioral assessments.
RESULTS
We provide the results from a preliminary study (n = 29) of non-randomized pilot participants who received both the exercise and Mindfulness-Based Stress Reduction interventions. We also provide details on the recruitment and baseline characteristics of the randomized controlled trial sample (n = 585).
CONCLUSION
When complete, the Mindfulness, Education, and Exercise study will inform the research community on the efficacy of these widely available interventions improve cognitive functioning in older adults.",2020,"Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction, may reduce or reverse cognitive decline, but rigorously designed randomized controlled trials are needed to test the efficacy of such interventions.
",['older adults'],"['interventions-mindfulness training plus moderate-to-vigorous intensity exercise or moderate-to-vigorous intensity exercise alone-compared with a health education control group', 'exercise and Mindfulness-Based Stress Reduction interventions', 'Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction']","['cognitive function', 'cognitive functioning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.118193,"Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction, may reduce or reverse cognitive decline, but rigorously designed randomized controlled trials are needed to test the efficacy of such interventions.
","[{'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Hayley S', 'Initials': 'HS', 'LastName': 'Ripperger', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Voegtle', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Beau M', 'Initials': 'BM', 'LastName': 'Ances', 'Affiliation': 'Department of Neurology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Balota', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Bower', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Depp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eyler', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Foster', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Head', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hershey', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hickman', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Noralinda', 'Initials': 'N', 'LastName': 'Kamantigue', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Yingling', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Center for Human Nutrition, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Rodebaugh', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Shimony', 'Affiliation': 'Mallinckrodt Institute of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Snyder', 'Affiliation': 'Mallinckrodt Institute of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stephens', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tate', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Uhrich', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wing', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520931864']
1106,32601033,"A propensity score weighted comparison of Vedolizumab, Adalimumab, and Golimumab in patients with ulcerative colitis.","BACKGROUND
No real-life study on the comparative effectiveness of Vedolizumab (VDZ), Adalimumab (ADA), and Golimumab (GOL) in ulcerative colitis (UC) is currently available.
AIMS
To compare the effectiveness of the three biologics in consecutive patients with UC.
METHODS
A three-arms propensity score-adjusted analysis was performed using the Inverse Probability of Treatment Weighting method.
RESULTS
463 treatments (VDZ: n = 187; ADA: n = 168; GOL: n = 108) were included (median follow-up: 47.6 weeks). At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons). At 52 weeks (n = 377), a steroid-free remission was reported in 51.5% patients in the VDZ group, in 31.2% patients in the ADA group, and in 29.4% patients in the GOL group (p = 0.002 for VDZ vs. ADA, p = 0.001 for VDZ vs. GOL, p = n.s. for ADA vs. GOL). Cox survival analysis demonstrated that patients treated with VDZ had reduced probability of treatment discontinuation compared to those treated with ADA (HR: 0.42, 95% CI 0.28-0.64, p < 0.001) and GOL (HR: 0.30, 95% CI 0.19-0.46, p < 0.001), while patients treated with ADA had reduced risk of treatment discontinuation compared to those treated with GOL (HR: 0.71, 95% CI 0.50-1.00, p = 0.048).
CONCLUSIONS
VDZ was superior to ADA and GOL at 52 weeks and as treatment persistence, while ADA showed a superior treatment persistence compared to GOL.",2020,"At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons).","['ulcerative colitis (UC', '463 treatments (VDZ: n\u202f=\u202f187; ADA: n\u202f=\u202f168', 'patients with ulcerative colitis', 'consecutive patients with UC']","['VDZ', 'ADA', 'Vedolizumab (VDZ), Adalimumab (ADA), and Golimumab (GOL', 'Vedolizumab, Adalimumab, and Golimumab']","['probability of treatment discontinuation', 'steroid-free remission', 'risk of treatment discontinuation', 'Cox survival analysis']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",108.0,0.0991138,"At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons).","[{'ForeName': 'Fabio Salvatore', 'Initials': 'FS', 'LastName': 'Macaluso', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy. Electronic address: fsmacaluso@gmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ventimiglia', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fries', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.U. Policlinico ""G. Martino"", Messina, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Viola', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.U. Policlinico ""G. Martino"", Messina, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cappello', 'Affiliation': 'Gastroenterology and Hepatology Unit, A.O.U. Policlinico ""G. Giaccone"", Palermo, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Scrivo', 'Affiliation': 'Gastroenterology and Hepatology Unit, A.O.U. Policlinico ""G. Giaccone"", Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Magnano', 'Affiliation': 'Gastroenterology Unit, A.O.U. Policlinico ""Vittorio Emanuele"", Catania, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Pluchino', 'Affiliation': 'Gastroenterology Unit, A.O.U. Policlinico ""Vittorio Emanuele"", Catania, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Camilleri', 'Affiliation': 'Gastroenterology Unit, A.O.O.R. ""S. Elia- M. Raimondi"", Caltanissetta, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Garufi', 'Affiliation': 'Gastroenterology Unit, A.O.O.R. ""S. Elia- M. Raimondi"", Caltanissetta, Italy.'}, {'ForeName': 'Roberto Di', 'Initials': 'RD', 'LastName': 'Mitri', 'Affiliation': 'Gastroenterology and endoscopy Unit, A.R.N.A.S. ""Civico Di Cristina Benfratelli"", Palermo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Mocciaro', 'Affiliation': 'Gastroenterology and endoscopy Unit, A.R.N.A.S. ""Civico Di Cristina Benfratelli"", Palermo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Magrì', 'Affiliation': 'Gastroenterology Unit, A.O. ""Santa Marta e S. Venera"", Acireale, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Ferracane', 'Affiliation': 'Gastroenterology Unit, A.O. ""Santa Marta e S. Venera"", Acireale, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Citrano', 'Affiliation': 'Pediatrics Unit, A.O.O.R. ""Villa Sofia-Cervello"", Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Graziano', 'Affiliation': 'Pediatrics Unit, A.O.O.R. ""Villa Sofia-Cervello"", Palermo, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Bertolami', 'Affiliation': 'Gastroenterology Unit, A.O.O.R. ""Papardo Piemonte"", Messina, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Renna', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Orlando', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Rizzuto', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cottone', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Ambrogio', 'Initials': 'A', 'LastName': 'Orlando', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.06.014']
1107,32609011,Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock. A Clinical Trial.,"Rationale: Exogenous angiotensin II increases mean arterial pressure in patients with catecholamine-resistant vasodilatory shock (CRVS). We hypothesized that renin concentrations may identify patients most likely to benefit from such therapy. Objectives: To test the kinetic changes in renin concentrations and their prognostic value in patients with CRVS. Methods: We analyzed serum samples from patients enrolled in the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) trial for renin, angiotensin I, and angiotensin II concentrations before the start of administration of angiotensin II or placebo and after 3 hours. Measurements and Main Results: Baseline serum renin concentration (normal range, 2.13-58.78 pg/ml) was above the upper limits of normal in 194 of 255 (76%) study patients with a median renin concentration of 172.7 pg/ml (interquartile range [IQR], 60.7 to 440.6 pg/ml), approximately threefold higher than the upper limit of normal. Renin concentrations correlated positively with angiotensin I/II ratios ( r = 0.39; P < 0.001). At 3 hours after initiation of angiotensin II therapy, there was a 54.3% reduction (IQR, 37.9% to 66.5% reduction) in renin concentration compared with a 14.1% reduction (IQR, 37.6% reduction to 5.1% increase) with placebo ( P < 0.0001). In patients with renin concentrations above the study population median, angiotensin II significantly reduced 28-day mortality to 28 of 55 (50.9%) patients compared with 51 of 73 patients (69.9%) treated with placebo (unstratified hazard ratio, 0.56; 95% confidence interval, 0.35 to 0.88; P = 0.012) ( P = 0.048 for the interaction). Conclusions: The serum renin concentration is markedly elevated in CRVS and may identify patients for whom treatment with angiotensin II has a beneficial effect on clinical outcomes.Clinical trial registered with www.clinicaltrials.gov (NCT02338843).",2020,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"['CRVS patients', 'patients with catecholamine-resistant vasodilatory shock (CRVS', 'Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock', 'patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of']","['placebo', 'angiotensin', 'angiotensin II therapy', 'angiotensin II or placebo']","['renin levels', 'Renin and Survival', 'Renin levels', 'renin concentration', 'Baseline serum renin concentration', '28-day mortality', 'mean arterial pressure', 'median renin concentration', 'Serum renin concentration']","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.111806,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"[{'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Centre for Integrated Critical Care, Department of Medicine & Radiology, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Intensive Care Unit, Royal Surrey Hospital Foundation Trust, Guildford, United Kingdom.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, and.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McCurdy', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, School of Medicine, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'Department of Critical Care, Regions Hospital, University of Minnesota, St. Paul, Minnesota.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boldt', 'Affiliation': 'Division of Critical Care, Department of Anesthesiology and Perioperative Medicine, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Division of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Section on Critical Care Medicine, School of Medicine, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Albertson', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, School of Medicine, University of California-Davis, Northern California Health System, Mather, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Renal Division, Department of Medicine, Emory University Medical Center, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Handisides', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Tidmarsh', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'La Jolla Pharmaceutical Company, San Diego, California.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, Guy's & St. Thomas' Hospital, King's College London, London, United Kingdom.""}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2172OC']
1108,32609036,Evaluation of a Novel Educational Intervention to Improve Conversations About Implantable Cardioverter-Defibrillators Management in Patients with Advanced Heart Failure.,"Background: Implantable cardioverter-defibrillators (ICDs) reduce the incidence of sudden cardiac death for high-risk patients with heart failure (HF), but shocks from these devices can also cause pain and anxiety at the end of life. Although professional society recommendations encourage proactive discussions about ICD deactivation, clinicians lack training in conducting these conversations, and they occur infrequently. Methods: As part of a six-center randomized controlled trial, we evaluated the educational component of a multicomponent intervention shown to increase conversations about ICD deactivation by clinicians who care for a subset of patients with advanced HF. This consisted of a 90-minute training workshop designed to improve the quality and frequency of conversations about ICD management. To characterize its utility as an isolated intervention, we compared HF clinicians' pre- and postworkshop scores (on a 5-point Likert scale) assessing self-reported confidence and skills in specific practices of advance care planning, ICD deactivation discussions, and empathic communication. Results: Forty intervention-group HF clinicians completed both pre- and postworkshop surveys. Preworkshop scores showed high baseline levels of confidence (4.36, standard deviation [SD] = 0.70) and skill (4.08, SD = 0.72), whereas comparisons of pre- and postworkshop scores showed nonsignificant decreases in confidence (-1.16, p = 0.252) and skill (-0.20, p = 0.843) after the training session. Conclusions: Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention. However, our data did demonstrate that HF clinicians had high baseline self-perceptions of their skills in advance care planning conversations and appear to be well-primed for further professional development to improve communication in the setting of advanced HF.",2020,Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention.,"['patients with advanced HF', 'Patients with Advanced Heart Failure', 'high-risk patients with heart failure (HF']","['Implantable cardioverter-defibrillators (ICDs', 'Novel Educational Intervention', 'multicomponent intervention']","['self-assessment ratings', 'sudden cardiac death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}]",,0.0354669,Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention.,"[{'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Kwok', 'Affiliation': 'Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel Hospital, New York, New York, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Mather', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKendrick', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gelfman', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Mathew D', 'Initials': 'MD', 'LastName': 'Hutchinson', 'Affiliation': 'Division of Cardiovascular Medicine, Sarver Heart Center, University of Arizona College of Medicine Tucson, Tucson, Arizona, USA.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Lampert', 'Affiliation': 'Department of Internal Medicine, Section of Cardiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Hannah I', 'Initials': 'HI', 'LastName': 'Lipman', 'Affiliation': 'Department of Internal Medicine, Hackensack Meridian School of Medicine at Seton Hall University, Nutley, New Jersey, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Birmingham Veterans Affairs Medical Center, Department of Medicine and UAB Center for Palliative and Supportive Care, University of Alabama Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kalman', 'Affiliation': 'Lenox Hill Hospital, Northwell Health, New York, New York, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pinney', 'Affiliation': 'Division of Cardiology, Samuel Bronfman Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'R Sean', 'Initials': 'RS', 'LastName': 'Morrison', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Goldstein', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0022']
1109,32603789,Digoxin Initiation and Outcomes in Patients with Heart Failure (HFrEF and HFpEF) and Atrial Fibrillation.,"BACKGROUND
Digoxin reduces the risk of heart failure hospitalization but has no effect on mortality in patients with heart failure without atrial fibrillation in the randomized controlled trial setting. Observational studies of digoxin use in patients with atrial fibrillation have suggested a higher risk for poor outcomes. Less is known about this association in patients with heart failure and atrial fibrillation, the examination of which was the objective of the current study.
METHODS
We conducted an observational propensity score-matched study of predischarge digoxin initiation in 1768 hospitalized patients with heart failure and atrial fibrillation in the Medicare-linked Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF) registry, balanced on 56 baseline characteristics (mean age, 79 years; 55% women; 7% African American). Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes were estimated for the 884 patients initiated on digoxin compared with 884 not initiated on digoxin.
RESULTS
HRs (95% CIs) for 30-day, 2-year, and 4-year all-cause mortality were 0.80 (0.55-1.18; P = .261), 0.94 (0.87-1.16; P = .936), and 1.01 (0.90-1.14; P = .729), respectively. Respective HRs (95% CIs) for heart failure readmission were 0.67 (0.49-0.92; P = .014), 0.81 (0.69-0.94; P = .005), and 0.85 (0.74-0.97; P = .022), and those for all-cause readmission were 0.78 (0.64-0.96; P = .016), 0.90 (0.81-1.00; P = .057), and 0.91 (0.83-1.01; P = .603). These associations were homogeneous between patients with left ventricular ejection fraction ≤45% vs >45%.
CONCLUSIONS
Among hospitalized older patients with heart failure (HFrEF and HFpEF) and atrial fibrillation, initiation of digoxin was associated with a lower risk of heart failure readmission but had no association with mortality.",2020,"Respective HRs (95% CIs) for heart failure readmission were 0.67 (0.49-0.92; p=0.014), 0.81 (0.69-0.94; p=0.005), and 0.85 (0.74-0.97; p=0.022), and those for all-cause readmission were 0.78 (0.64-0.96; p=0.016), 0.90 (0.81-1.00; p=0.057), and 0.91","['1768 hospitalized patients with heart failure and atrial fibrillation in Medicare-linked OPTIMIZE-HF registry, balanced on 56 baseline characteristics (mean age, 79 years; 55% women; 7% African American', 'Patients with Heart Failure ', 'patients with heart failure and atrial fibrillation', '884 patients initiated on', 'patients with atrial fibrillation', 'hospitalized older patients with HFrEF and HFpEF and atrial fibrillation, initiation of', 'patients with heart failure without atrial fibrillation']","['pre-discharge digoxin initiation', 'digoxin', 'HFrEF and HFpEF', 'Digoxin']","['heart failure readmission', '30-day, 2-year, and 4-year all-cause mortality', 'Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1768.0,0.168502,"Respective HRs (95% CIs) for heart failure readmission were 0.67 (0.49-0.92; p=0.014), 0.81 (0.69-0.94; p=0.005), and 0.85 (0.74-0.97; p=0.022), and those for all-cause readmission were 0.78 (0.64-0.96; p=0.016), 0.90 (0.81-1.00; p=0.057), and 0.91","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC. Electronic address: nankumar.singh@va.gov.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC.'}, {'ForeName': 'Pamela E', 'Initials': 'PE', 'LastName': 'Karasik', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Phillip H', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wopperer', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC.'}, {'ForeName': 'Cherinne', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Tummala', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Markus S', 'Initials': 'MS', 'LastName': 'Anker', 'Affiliation': 'Charité Campus Virchow Klinikum, Berlin, Germany; Charité Campus Benjamin Franklin, Berlin, Germany; Berlin Institute of Health Center for Regenerative Therapies, Germany; German Centre for Cardiovascular Research, Berlin, Germany.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Faselis', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Deedwania', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; University of California, San Francisco.'}, {'ForeName': 'Charity J', 'Initials': 'CJ', 'LastName': 'Morgan', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; University of Alabama at Birmingham.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Allman', 'Affiliation': 'George Washington University, Washington, DC; University of Alabama at Birmingham.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; George Washington University, Washington, DC. Electronic address: ali.ahmed@va.gov.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.05.030']
1110,32592589,The Agents Intervening against Delirium in the Intensive Care Unit Trial (AID-ICU trial): A detailed statistical analysis plan.,"BACKGROUND
The AID-ICU trial aims to assess the benefits and harms of haloperidol for the treatment of delirium in acutely admitted, adult intensive care unit (ICU) patients. This paper describes the detailed statistical analysis plan for the primary publication of results from the AID-ICU trial.
METHODS
The AID-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomized, blinded, parallel-group trial allocating 1000 adult ICU patients with manifest delirium 1:1 to haloperidol or placebo. The primary outcome measure is days alive and out of hospital within 90 days post-randomization. Secondary outcome measures are days alive without delirium or coma, serious adverse reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomization. Statistical analysis will be conducted in accordance with the current pre-specified statistical analysis plan. One formal interim analysis will be performed. The primary outcome will be adjusted for stratification variables (site and delirium motor subtype) and compared between treatment groups using a likelihood ratio test described by Jensen et al A secondary analysis will be conducted with additional adjustment of the primary outcome for prognostic variables at baseline. The primary conclusion of the trial will be based on the intention-to-treat analysis of the primary outcome adjusted for stratification variables.
CONCLUSION
The AID-ICU trial will provide important, high-quality data on the benefits and harms of treatment with haloperidol in acutely admitted, adult patients with manifest delirium in the ICU.",2020,"Secondary outcome measures are days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation.","['delirium in acutely admitted, adult intensive care unit (ICU) patients', '1000 adult ICU patients with manifest delirium 1:1 to', 'acutely admitted, adult patients with manifest delirium in the ICU']","['haloperidol or placebo', 'haloperidol']","['days alive and out of hospital within 90 days post-randomisation', 'stratification variables (site and delirium motor subtype', 'days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439234', 'cui_str': 'year'}]",1000.0,0.342267,"Secondary outcome measures are days alive without delirium or coma, Serious Adverse Reactions (SARs) to haloperidol, use of escape medicine, days alive without mechanical ventilation, and mortality, health-related quality-of-life measures and cognitive function 1-year post-randomisation.","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Andersen-Ranberg', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Lone M', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Wetterslev', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mathiesen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Camilla B', 'Initials': 'CB', 'LastName': 'Mortensen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Estrup', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Koege, Denmark.'}, {'ForeName': 'Bjørn H', 'Initials': 'BH', 'LastName': 'Ebdrup', 'Affiliation': 'Center for Neuropsychiatric Schizophrenia Research (CNSR) & Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS), Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'Department of Anaesthesiology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Citerio', 'Affiliation': 'Universitá Milano Bicocca, Monza, Italy.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Caballero', 'Affiliation': 'Hospital Universitari Arnau de Vilanova de Lleida, IRBLLeida, Departament de Medicina, Universitat Autònoma de Barcelona-UAB, Barcelona, Spain.'}, {'ForeName': 'Matthew P G', 'Initials': 'MPG', 'LastName': 'Morgan', 'Affiliation': 'Adult Critical Care, University of Wales, Cardiff, Wales.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Oxenbøll-Collet', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Sven-Olaf', 'Initials': 'SO', 'LastName': 'Weber', 'Affiliation': 'General Intensive Care Unit, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sofie Andreasen', 'Affiliation': 'Intensive Care Unit, Dept. of Anesthesiology and Intensive Care, Herlev Hospital, Herlev, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Helle B S', 'Initials': 'HBS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Nykøbing Falster Hospital, Nykøbing, Denmark.'}, {'ForeName': 'Louise G', 'Initials': 'LG', 'LastName': 'Nielsen', 'Affiliation': 'Department of Intensive Care, Odense University Hospital, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Uslu', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Troels B', 'Initials': 'TB', 'LastName': 'Jensen', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Thee', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Sønderjylland, Aabenraa, Denmark.'}, {'ForeName': 'Nilanjan', 'Initials': 'N', 'LastName': 'Dey', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Hospital Unit West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Centre for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13661']
1111,32612066,Effects of dapagliflozin on renin-angiotensin-aldosterone system under renin-angiotensin system inhibitor administration.,"Sodium-glucose cotransporter-2 inhibitors (SGLT2Is) are reported to prevent cardiovascular events by a mechanism possibly including diuresis and sodium excretion. In this respect, diuresis-induced compensatory upregulation of the renin-angiotensin-aldosterone (RAA) system should be clarified and we performed a randomized controlled trial using dapagliflozin, an SGLT2I. Hypertensive diabetic patients taking angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers were randomly assigned to a dapagliflozin group (DAPA) or a control group (CTRL) with the difference in the changes in plasma renin activity (PRA) after 24 weeks of the treatment as the primary outcome. PRA, plasma aldosterone concentration (PAC), age, sex, BMI, blood pressure, pulse rate, eGFRcys, and HbA1c were not different between the groups at baseline. After 24 weeks, the changes in the PRA from the baseline of the DAPA (n = 44) and CTRL (n = 39) groups were 6.30 ± 15.55 and 1.42 ± 11.43 ng/mL/h, respectively (p = 0.11) although the power of detection was too small. However, post hoc nonparametric analyses revealed that there was a definite increase in the PRA and PAC in the DAPA group (p < 0.0001 and p = 0.00025, respectively) but not in the CTRL group. The PRA in the DAPA group after 24 weeks treatment was significantly elevated compared to the CTRL group (p = 0.013) but not for the PAC. Accordingly, it would be suggested that dapagliflozin may not induce a profound increase, if any, in PAC after 24 weeks of treatment in hypertensive type 2 diabetic patients under RAA suppression.",2020,"However, post hoc nonparametric analyses revealed that there was a definite increase in the PRA and PAC in the DAPA group (p < 0.0001 and p = 0.00025, respectively) but not in the CTRL group.","['hypertensive type 2 diabetic patients under RAA suppression', 'SGLT2I. Hypertensive diabetic patients taking angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers']","['Sodium-glucose cotransporter-2 inhibitors (SGLT2Is', 'dapagliflozin', 'CTRL', 'dapagliflozin group (DAPA) or a control group (CTRL']","['PRA and PAC', 'PRA, plasma aldosterone concentration (PAC), age, sex, BMI, blood pressure, pulse rate, eGFRcys, and HbA1c', 'plasma renin activity (PRA']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",44.0,0.0301429,"However, post hoc nonparametric analyses revealed that there was a definite increase in the PRA and PAC in the DAPA group (p < 0.0001 and p = 0.00025, respectively) but not in the CTRL group.","[{'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Isshiki', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Sakuma', 'Affiliation': 'Caress Sapporo Hokko Memorial Clinic, Hokkaido 065-0027, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Hayashino', 'Affiliation': 'Department of Endocrinology, Tenri Hospital, Nara 632-8552, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Sumita', 'Affiliation': 'Department of Endocrinology and Diabetes, Japanese Red Cross Ogawa Hospital, Saitama 355-0397, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolism, Jichi Medical University Saitama Medical Center, Saitama 330-8503, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Medicine II, Kansai Medical University, Osaka 573-1191, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Shiojima', 'Affiliation': 'Department of Medicine II, Kansai Medical University, Osaka 573-1191, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Satoh-Asahara', 'Affiliation': 'Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Kitazato', 'Affiliation': 'Division of Diabetes and Endocrinology, Japanese Red Cross Omori Hospital, Tokyo 143-8527, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ito', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}, {'ForeName': 'Daigo', 'Initials': 'D', 'LastName': 'Saito', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Hatano', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Ikegami', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Iida', 'Affiliation': 'Department of General Internal Medicine, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimada', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Department of Endocrinology and Diabetes, Saitama Medical University Hospital, Saitama 350-0495, Japan.'}]",Endocrine journal,['10.1507/endocrj.EJ20-0222']
1112,32594522,"Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial.","BACKGROUND
Patients with plaque psoriasis treated with biologic therapies need more efficacious, safe and convenient treatments to improve quality of life. Risankizumab and secukinumab inhibit interleukin-23 and interleukin-17A, respectively, and are effective in adult patients with moderate-to-severe plaque psoriasis but have different dosing regimens.
OBJECTIVES
To compare directly the efficacy and safety of risankizumab vs. secukinumab over 52 weeks.
METHODS
IMMerge was an international, phase III, multicentre, open-label, efficacy-assessor-blinded, active-comparator study, in which adult patients with chronic, moderate-to-severe plaque psoriasis were randomized in a 1 : 1 ratio to treatment with risankizumab 150 mg or secukinumab 300 mg. Primary efficacy endpoints were the proportions of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 (noninferiority comparison with margin of 12%) and week 52 (superiority comparison).
RESULTS
In total 327 patients from nine countries were treated with risankizumab (n = 164) or secukinumab (n = 163). Risankizumab was noninferior to secukinumab in the proportion of patients achieving PASI 90 at week 16 [73·8% vs. 65·6%; difference of 8·2%, 96·25% confidence interval (CI)-2·2 to 18·6; within the 12% noninferiority margin] and superior to secukinumab at week 52 (86·6% vs. 57·1%; difference of 29·8%, 95% CI 20·8-38·8; P < 0·001), thus meeting both primary endpoints. All secondary endpoints (PASI 100, static Physician's Global Assessment 0 or 1, and PASI 75) at week 52 demonstrated superiority for risankizumab vs. secukinumab (P < 0·001). No new safety concerns were identified.
CONCLUSIONS
At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab.",2020,"Risankizumab was noninferior to secukinumab in proportion of patients achieving PASI 90 at week 16 [73∙8% vs. 65∙6%; difference of 8∙2% [96∙25% confidence interval (CI) -2∙2, 18∙6] within 12% noninferiority margin], and superior to secukinumab at week 52 [86∙6% vs. 57∙1%; difference of 29∙8% (95% CI 20∙8, 38∙8); P<0∙001], thus meeting both primary end points.","['adult patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis (IMMerge', '327 patients from nine countries', 'adult patients with chronic, moderate-to-severe plaque psoriasis', 'Patients with plaque psoriasis treated with']","['Risankizumab and secukinumab inhibit interleukin (IL)-23 and IL-17A', 'biologic therapies', 'risankizumab vs. secukinumab', 'risankizumab', 'risankizumab 150mg or secukinumab 300mg', 'secukinumab', 'Risankizumab']","['quality of life', 'points (PASI 100, static Physician Global Assessment 0 or 1, and PASI 75', 'Efficacy and safety', 'Psoriasis Area Severity Index (PASI 90']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}]",327.0,0.270528,"Risankizumab was noninferior to secukinumab in proportion of patients achieving PASI 90 at week 16 [73∙8% vs. 65∙6%; difference of 8∙2% [96∙25% confidence interval (CI) -2∙2, 18∙6] within 12% noninferiority margin], and superior to secukinumab at week 52 [86∙6% vs. 57∙1%; difference of 29∙8% (95% CI 20∙8, 38∙8); P<0∙001], thus meeting both primary end points.","[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Centre, Portland, OR, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Laval University and Centre de Recherche Dermatologique du Québec Métropolitain, Québec City, QC, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beeck', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Paul Sabatier University and Larrey Hospital, Toulouse, France.'}]",The British journal of dermatology,['10.1111/bjd.19341']
1113,32595189,The orthodontic bonding properties of human enamel after cryopreservation.,"The aim was to investigate the effect of cryopreservation on the enamel bonding properties of orthodontic brackets. Sixty-six human premolars were randomly allocated to a control group or a cryopreserved group. Conventional stainless-steel orthodontic brackets were bonded with a light cure adhesive on the buccal side of the premolars. The shear bond strength (SBS) was determined at a crosshead speed of 1 mm/min. The SBS and adhesive remnant index (ARI) were evaluated respectively by an independent samples t test and Fisher's exact test (α≤0.05). The mean failure load was lower in the cryopreserved group. However, this difference in SBS was not significant (p=0.443). In both groups, the ARI mostly indicated a failure at the enamel-adhesive interface. The mean ARI scores for both groups were not significantly different (p=0.099). Within the limitations of this macro bond strength testing, it can be concluded that cryopreservation does not significantly affect the bonding properties of enamel.",2020,The mean ARI scores for both groups were not significantly different (p=0.099).,"['Sixty-six human premolars', 'human enamel after cryopreservation']",[],"['SBS', 'mean ARI scores', 'mean failure load', 'SBS and adhesive remnant index (ARI', 'shear bond strength (SBS']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]",[],"[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",66.0,0.0395137,The mean ARI scores for both groups were not significantly different (p=0.099).,"[{'ForeName': 'Noëmi M C DE', 'Initials': 'NMC', 'LastName': 'Roo', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Deboosere', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Laurent A M', 'Initials': 'LAM', 'LastName': 'Thierens', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Vercruysse', 'Affiliation': 'Biomaterials Group, Department of Basic Medical Sciences, Ghent University.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Temmerman', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Ronald M H', 'Initials': 'RMH', 'LastName': 'Verbeeck', 'Affiliation': 'Biomaterials Group, Department of Basic Medical Sciences, Ghent University.'}, {'ForeName': 'Guy A M DE', 'Initials': 'GAM', 'LastName': 'Pauw', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}]",Dental materials journal,['10.4012/dmj.2019-208']
1114,32600866,Tooth discoloration and the effects of internal bleaching on the novel endodontic filling material SavDen® MTA.,"BACKGROUND/PURPOSE
Mineral trioxide aggregate (MTA) was widely used in endodontic therapy as bioceramic material. Although MTA has high biocompatibility, it may lead to tooth discoloration. The aim of this study was to investigate the discoloration of two different bioceramic materials and the effects of internal bleaching.
METHODS
Thirty single-canal mandibular premolars were extracted and randomly assigned to three groups (n = 10), white ProRoot® MTA, SavDen® MTA and a control group. Endodontic access opening, cleaning and shaping were performed, then the teeth were obturated using the two bioceramic materials. Tooth color was recorded at baseline, day 1, and 1, 2, 4, 6, 8, 12, 16, and 24 weeks after treatment. At the end of 24 weeks, sodium perborate was used to perform internal bleaching. Tooth color was recorded at 1, 2, and 6 weeks subsequently. Teeth were measured using a DeguDent® spectrophotometer, and data were transformed into Commission Internationale de l'Eclairage (CIE) L∗a∗b∗ system.
RESULTS
Teeth treated with white ProRoot® MTA showed significant color change and decrease in L∗ value. Internal bleaching leaded to decrease of the ΔE∗ value for all three groups and increase in the L∗ value. There was no difference in tooth discoloration between SavDen® MTA and the control group after obturation and internal bleaching.
CONCLUSION
In terms of visual perception, white ProRoot® MTA tends to cause black and blue discoloration. SavDen® MTA, formulated with calcium lactate gluconate, could be used to reduce tooth discoloration in endodontic treatment.",2021,"There was no difference in tooth discoloration between SavDen® MTA and the control group after obturation and internal bleaching.
",['Thirty single-canal mandibular premolars'],"['internal bleaching', 'calcium lactate gluconate', 'white ProRoot® MTA, SavDen® MTA and a control group', 'MTA', 'Mineral trioxide aggregate (MTA', 'white ProRoot® MTA']","['L∗ value', 'tooth discoloration', 'Tooth color']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0222756', 'cui_str': 'Structure of mandibular canal'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0771535', 'cui_str': 'calcium lactate gluconate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1098459', 'cui_str': 'aggregate ProRoot'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}]",30.0,0.0169253,"There was no difference in tooth discoloration between SavDen® MTA and the control group after obturation and internal bleaching.
","[{'ForeName': 'Wan-Chun', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Liang-Yi', 'Initials': 'LY', 'LastName': 'Tsai', 'Affiliation': 'Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Hao', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Nai-Chia', 'Initials': 'NC', 'LastName': 'Teng', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jen-Chang', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Nanomedicine and Medical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Sung-Chih', 'Initials': 'SC', 'LastName': 'Hsieh', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: endo@tmu.edu.tw.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2020.06.016']
1115,32600891,Use of a Secure Web-Based Data Management Platform to Track Resident Operative Performance and Program Educational Quality Over Time.,"OBJECTIVE
In surgery residency programs, Accreditation Council for Graduate Medical Education mandated performance assessment can include assessment in the operating room to demonstrate that necessary quality and autonomy goals are achieved by the conclusion of training. For the past 3 years, our institution has used The Ottawa Surgical Competency Operating Room Evaluation (O-SCORE) instrument to assess and track operative skills. Evaluation is accomplished in near real-time using a secure web-based platform for data management and analytics (Firefly). Simultaneous to access of the platform's case logging function, the O-SCORE instrument is delivered to faculty members for rapid completion, facilitating quality, and timeliness of feedback. We sought to demonstrate the platform's utility in detecting operative performance changes over time in response to focused educational interventions based on stored case log and O-SCORE data.
DESIGN
Stored resident performance assessments for the most frequently performed laparoscopic procedures (cholecystectomy, appendectomy, inguinal hernia repair, ventral hernia repair) were examined for 3 successive academic years (2016-2019). During this time, 4 of 36 residents had received program-assigned supplemental simulation training to improve laparoscopic skills. O-SCORE data for these residents were extracted from peer data, which were used for comparisons. Assigned training consisted of a range of videoscopic and virtual reality skills drills with performance objectives. O-SCORE responses were converted to integers and autonomy scores for items pertaining to technical skill were compared before and after educational interventions (Student's t-tests). These scores were also compared to aggregate scores in the nonintervention group. Bayesian-modeled learning curves were used to characterize patterns of improvement over time.
SETTING
University of Massachusetts Medical School-Baystate Surgery Residency and Baystate Medical Center PARTICIPANTS: General surgery residents (n = 36) RESULTS: During the period of review, 3325 resident cases were identified meeting the case type criteria. As expected, overall autonomy increased with the number of cases performed. The 4 residents who had been assigned supplemental training (6-18 months) had preintervention score averages that were lower than that of the nonintervention group (2.25 ± 0.43 vs 3.57 ± 1.02; p < 0.0001). During the respective intervention periods, all 4 residents improved autonomy scores (increase to 3.40 ± 0.61; p < 0.0001). Similar improvements were observed for tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills. Postintervention scores were not significantly different compared to scores for the non-intervention group. Bayesian-modeled learning curves showed a similar pattern of postintervention performance improvement.
CONCLUSIONS
The data management platform proved to be an effective tool to track responses to supplemental training that was deemed necessary to close defined skills gaps in laparoscopic surgery. This could be seen both in individual and in aggregated data. We were gratified that at the conclusion of the supplemental training, O-SCORE results for the intervention group were not different than those seen in the non-intervention group.",2020,"Similar improvements were observed for tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills.","['36 residents had received', 'University of Massachusetts Medical School-Baystate Surgery Residency and Baystate Medical Center PARTICIPANTS: General surgery residents (n\u202f=\u202f36', '3325 resident cases were identified meeting the case type criteria']","['program-assigned supplemental simulation training', 'laparoscopic procedures (cholecystectomy, appendectomy, inguinal hernia repair, ventral hernia repair']","['Postintervention scores', 'autonomy scores', 'overall autonomy', 'O-SCORE responses', 'tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills', 'preintervention score averages']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0374018,"Similar improvements were observed for tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills.","[{'ForeName': 'Adriana L', 'Initials': 'AL', 'LastName': 'Meholick', 'Affiliation': 'University of Massachusetts Medical School-Baystate, Department of Surgery, Springfield, Massachusetts.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Jesneck', 'Affiliation': 'Firefly Lab, Cambridge, Massachusetts.'}, {'ForeName': 'Ruchi M', 'Initials': 'RM', 'LastName': 'Thanawala', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa.'}, {'ForeName': 'Neal E', 'Initials': 'NE', 'LastName': 'Seymour', 'Affiliation': 'University of Massachusetts Medical School-Baystate, Department of Surgery, Springfield, Massachusetts. Electronic address: Neal.Seymour@baystatehealth.org.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.05.022']
1116,32608096,A randomised clinical pilot trial to test the effectiveness of parent training with video modelling to improve functioning and symptoms in children with autism spectrum disorders and intellectual disability.,"BACKGROUND
Poor eye contact and joint attention are early signs of autism spectrum disorder (ASD) and important prerequisites for developing other socio-communicative skills. Teaching parents evidence-based techniques to improve these skills can impact the overall functioning of children with ASD. We aimed to analyse the impact of conducting a group parent-training intervention with video modelling to improve the intelligent quotient (IQ), social and communication functioning and to minimise symptoms in children with ASD and intellectual disability (ID).
METHODS
Study design: A multicentre, single-blinded, randomised clinical pilot trial of parent training using video modelling was conducted.
SAMPLE
Sixty-seven parents of children with ASD, aged between 3 and 6 years and with IQs between 50 and 70, were randomised: 34 to the intervention group and 33 to the control group. Intervention program: The intervention group received parent training over 22 sessions, and the control group received the standard community treatment.
INSTRUMENTS
Pre-evaluation and post-evaluation (week 28), the following were used: Autism Diagnostic Interview, Vineland Adaptive Behaviour Scale I, Snijders-Oomen Nonverbal Intelligence Test, Autism Behaviour Checklist and Hamilton Depression Rating Scale.
DATA ANALYSIS
Intention to treat and complier-average causal effect (CACE) were used to estimate the effects of the intervention.
RESULTS
There was a statistically significant improvement in the Vineland standardized communication scores in CACE (Cohen's d = 0.260). There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group. After the false discovery rate correction was applied, IQ remained statistically significant under both paradigms. The effect size for this adjusted outcome under the intention-to-treat paradigm was close to 0.4, and when considering adherence (CACE), the effect sizes were more robust (IQ's Cohen's d = 0.433).
CONCLUSIONS
Parent training delivered by video modelling can be a useful technique for improving the care given to children with ASD and ID, particularly in countries that lack specialists.",2020,There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group.,"['children with ASD', 'children with ASD and intellectual disability (ID', 'SAMPLE\n\n\nSixty-seven parents of children with ASD, aged between 3 and 6\xa0years and with IQs between 50 and 70, were randomised: 34 to the intervention group and 33 to the control group', 'children with autism spectrum disorders and intellectual disability']","['Intervention program', 'parent training with video modelling', 'parent training over 22 sessions, and the control group received the standard community treatment']","['Vineland standardized communication scores', 'I, Snijders-Oomen Nonverbal Intelligence Test, Autism Behaviour Checklist and Hamilton Depression Rating Scale', 'non-verbal IQ', 'functioning and symptoms', 'Autism Diagnostic Interview, Vineland Adaptive', 'autism symptomatology (Autism Behaviour Checklist total scores', 'Behaviour Scale', 'intelligent quotient (IQ), social and communication functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021705', 'cui_str': 'Intelligence test'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0700665,There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bordini', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Paula', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Cunha', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Caetano', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Bagaiolo', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Ribeiro', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'M C C', 'Initials': 'MCC', 'LastName': 'Martone', 'Affiliation': 'Department of Psychology - LAHMEI, Universidade Federal de São Carlos (UFSCar), Sao Carlos, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Portolese', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Moya', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brunoni', 'Affiliation': 'Development Disorders Program, Universidade Presbiteriana Mackenzie, Sao Paulo, Brazil.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bosa', 'Affiliation': 'Department of Psychology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Jesus Mari', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12759']
1117,32607749,"Low-dose IL-2 in children with recently diagnosed type 1 diabetes: a Phase I/II randomised, double-blind, placebo-controlled, dose-finding study.","AIMS/HYPOTHESIS
Low-dose IL-2 (ld-IL2) selectively activates and expands regulatory T cells (Tregs) and thus has the potential to skew the regulatory/effector T (Treg/Teff) cell balance towards improved regulation. We investigated which low doses of IL-2 would more effectively and safely activate Tregs during a 1 year treatment in children with recently diagnosed type 1 diabetes.
METHODS
Dose Finding Study of IL-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes (DF-IL2-Child) was a multicentre, double-blinded, placebo-controlled, dose-finding Phase I/II clinical trial conducted in four centres at university hospitals in France: 24 children (7-14 years old) with type 1 diabetes diagnosed within the previous 3 months were randomly assigned 1:1:1:1 to treatment by a centralised randomisation system, leading to a 7/5/6/6 patient distribution of placebo or IL-2 at doses of 0.125, 0.250 or 0.500 million international units (MIU)/m 2 , given daily for a 5 day course and then fortnightly for 1 year. A study number was attributed to patients by an investigator unaware of the randomisation list and all participants as well as investigators and staff involved in the study conduct and analyses were blinded to treatments. The primary outcome was change in Tregs, expressed as a percentage of CD4 + T cells at day 5. It pre-specified that a ≥60% increase in Tregs from baseline would identify Treg high responders.
RESULTS
There were no serious adverse events. Non-serious adverse events (NSAEs) were transient and mild to moderate. In treated patients vs placebo, the commonest NSAE was injection site reaction (37.9% vs 3.4%), whereas other NSAEs were at the same level (23.3% vs 19.2%). ld-IL2 induced a dose-dependent increase in the mean proportion of Tregs, from 23.9% (95% CI -11.8, 59.6) at the lowest to 77.2% (44.7, 109.8) at the highest dose, which was significantly different from placebo for all dose groups. However, the individual Treg responses to IL-2 were variable and fluctuated over time. Seven patients, all among those treated with the 0.250 and 0.500 MIU m -2 day -1 doses, were Treg high responders. At baseline, they had lower Treg proportions in CD4 + cells than Treg low responders, and serum soluble IL-2 receptor α (sIL-2RA) and vascular endothelial growth factor receptor 2 (VEGFR2) levels predicted the Treg response after the 5 day course. There was no significant change in glycaemic control in any of the dose groups compared with placebo. However, there was an improved maintenance of induced C-peptide production at 1 year in the seven Treg high responders as compared with low responders.
CONCLUSIONS/INTERPRETATION
The safety profile at all doses, the dose-dependent effects on Tregs and the observed variability of the Treg response to ld-IL2 in children with newly diagnosed type 1 diabetes call for use of the highest dose in future developments. The better preservation of insulin production in Treg high responders supports the potential of Tregs in regulating autoimmunity in type 1 diabetes, and warrants pursuing the investigation of ld-IL2 for its treatment and prevention.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01862120.
FUNDING
Assistance Publique-Hôpitaux de Paris, Investissements d'Avenir programme (ANR-11-IDEX-0004-02, LabEx Transimmunom and ANR-16-RHUS-0001, RHU iMAP) and European Research Council Advanced Grant (FP7-IDEAS-ERC-322856, TRiPoD).",2020,There were no serious adverse events.,"['four centres at university hospitals in France: 24 children (7-14\xa0years old) with type 1 diabetes diagnosed within the previous 3\xa0months', 'children with newly diagnosed type 1 diabetes', 'children with recently diagnosed type 1 diabetes', 'Children']","['IL-2', 'Low-dose IL-2', 'placebo or IL-2', 'placebo']","['serum soluble IL-2 receptor α (sIL-2RA) and', 'mean proportion of Tregs', 'vascular endothelial growth factor receptor 2 (VEGFR2) levels', 'serious adverse events', 'injection site reaction', 'glycaemic control', 'change in Tregs, expressed as a percentage of CD4 + T cells', 'maintenance of induced C-peptide production']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0378796', 'cui_str': 'KDR Tyrosine Kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",,0.490362,There were no serious adverse events.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rosenzwajg', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Randa', 'Initials': 'R', 'LastName': 'Salet', 'Affiliation': 'Department of Paediatrics, Nîmes University Hospital and Inserm U1183, Montpellier University, Montpellier, France.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Lorenzon', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Tchitchek', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roux', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Bernard', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Carel', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Robert-Debré Hospital, AP-HP Nord-Université de Paris Diderot & UFR de Médecine Paris Diderot, Paris, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Storey', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Robert-Debré Hospital, AP-HP Nord-Université de Paris Diderot & UFR de Médecine Paris Diderot, Paris, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': ""Department of Paediatric Endocrinology, Gynecology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Necker Enfants Malades Hospital, AP-HP.Centre & Université de Paris, UFR de Médecine Paris Descartes, Paris, France.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Beltrand', 'Affiliation': ""Department of Paediatric Endocrinology, Gynecology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Necker Enfants Malades Hospital, AP-HP.Centre & Université de Paris, UFR de Médecine Paris Descartes, Paris, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Amouyal', 'Affiliation': 'Department of Diabetology, Pitié-Salpêtrière Hospital, AP-HP. Sorbonne Université, Paris, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Hartemann', 'Affiliation': 'Department of Diabetology, Pitié-Salpêtrière Hospital, AP-HP. Sorbonne Université, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Corbeau', 'Affiliation': 'Immunology Department, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Lariboisière Hospital, Clinical Trial Unit, AP-HP.Nord, Paris, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Bibal', 'Affiliation': 'Department of Paediatric Endocrinology, Bicêtre Hospital, AP-HP.Université Paris Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bougnères', 'Affiliation': 'Department of Paediatric Endocrinology, Bicêtre Hospital, AP-HP.Université Paris Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Tu-Anh', 'Initials': 'TA', 'LastName': 'Tran', 'Affiliation': 'Department of Paediatrics, Nîmes University Hospital and Inserm U1183, Montpellier University, Montpellier, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Klatzmann', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France. david.klatzmann@sorbonne-universite.fr.""}]",Diabetologia,['10.1007/s00125-020-05200-w']
1118,32604430,"Music Therapy for Early Postoperative Pain, Anxiety, and Sleep in Patients after Mitral Valve Replacement.","BACKGROUND
To investigate the effect of music therapy on early postoperative pain, anxiety, and sleep quality in patients after mechanical mitral valve replacement (MVR).
METHODS
A total of 222 patients undergoing mechanical MVR were divided into two groups: the music group and the control group. The patients in the music group received 30 minutes of music therapy every day, whereas the patients in the control group had 30 minutes of quiet time. The visual analogue scale (VAS) was used to evaluate the degree of pain, and the Self-Rating Anxiety Scale (SAS) was used to evaluate the degree of early postoperative anxiety. We also recorded the sleep duration of the patients and used the Verran and Snyder-Halpern (VSH) Sleep Scale to evaluate the sleep quality of the patients.
RESULTS
The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group. The sleep duration in the music group was significantly greater than that in the control group. In the evaluation of sleep quality using the VSH Sleep Scale, the scores for sleep interruption, sleep length, sleep depth, degree of rest, and subjective sleep quality in the music group were significantly lower than those in the control group.
CONCLUSIONS
Music therapy can be an effective intervention to reduce early postoperative pain, relieve early postoperative anxiety, prolong sleep time, and improve the sleep quality of patients after mechanical MVR.",2020,"The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group.","['222 patients undergoing mechanical MVR', 'Patients after Mitral Valve Replacement', 'patients after mechanical mitral valve replacement (MVR']","['30\u2009minutes of music therapy', 'control group had 30\u2009minutes of quiet time', 'Music Therapy', 'music therapy', 'Music therapy']","['degree of pain, and the Self-Rating Anxiety Scale (SAS', 'VSH Sleep Scale, the scores for sleep interruption, sleep length, sleep depth, degree of rest, and subjective sleep quality', 'early postoperative anxiety', 'sleep duration', 'visual analogue scale (VAS', 'Verran and Snyder-Halpern (VSH) Sleep Scale', 'early postoperative pain, relieve early postoperative anxiety, prolong sleep time', 'early postoperative pain, anxiety, and sleep quality', 'sleep quality', 'Early Postoperative Pain, Anxiety, and Sleep', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0234452', 'cui_str': 'Prolonged sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",222.0,0.0232151,"The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group.","[{'ForeName': 'Qi-Liang', 'Initials': 'QL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0040-1713352']
1119,32613451,Muscle pain induced by hypertonic saline in the knee extensors decreases single-limb isometric time to task failure.,"PURPOSE
Increased nociceptive activity and the experience of exercise-induced pain (EIP) may contribute to fatigue during endurance exercise. To investigate this, a pain model that produces pain similar to EIP and decouples its relationship to exercise intensity is required. This study (1) compared the quality of pain caused by a hypertonic saline injection into the vastus lateralis in resting and exercise conditions, and (2) investigated whether this pain contributes to changes in time to task failure.
METHODS
On separate days, 18 participants completed a time to task failure at 20% maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection, and in a further three visits a time to task failure at 10% MVT following injection of isotonic saline, hypertonic saline or a control (no injection).
RESULTS
In a subset of eligible participants (n = 12), the hypertonic saline combined with 10% MVT produced a qualitative experience of pain (assessed by the McGill Pain Questionnaire) that felt similar to EIP. 10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
CONCLUSION
These findings demonstrate that hypertonic saline increases the intensity of pain during exercise, which results in a faster occurrence of exercise-induced fatigue. These results provide important evidence supporting pain as a limiting factor in endurance performance.",2020,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
",['18 participants completed a time to task failure at 20'],"['hypertonic saline combined with 10% MVT', 'maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection', 'isotonic saline, hypertonic saline or a control (no injection', 'exercise-induced pain (EIP', 'isotonic saline', 'hypertonic saline injection', 'hypertonic saline']","['quality of pain', 'knee extensors decreases single-limb isometric time to task failure', 'intensity of pain', 'elevated pain intensity', 'qualitative experience of pain', 'McGill Pain Questionnaire']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",,0.144328,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
","[{'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Micklewright', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Wivenhoe Park, Colchester, UK.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Winter', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Mauger', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK. lex.mauger@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-020-04425-2']
1120,32600942,Live birth after a freeze-only strategy versus fresh embryo transfer in three randomized trials considering progesterone concentration.,"RESEARCH QUESTION
Is there a difference in live birth rate between a freeze-only strategy and fresh embryo transfer, and what is the effect of varying progesterone concentrations on the day of human chorionic gonadotrophin (HCG) administration?
DESIGN
A secondary analysis of data from three randomized trials comparing the live birth rate after elective frozen versus fresh embryo transfer, which respectively enrolled 1508 women with polycystic ovary syndrome, 2157 ovulatory women who underwent cleavage-stage embryo transfer and 1650 ovulatory women who underwent single blastocyst transfer. Women were randomly assigned to the frozen or fresh embryo transfer group in the original trials. The primary outcome was live birth rate after the initial embryo transfer.
RESULTS
The live birth rate after a freeze-only strategy was consistently higher than fresh embryo transfer at any progesterone concentration on the day of HCG administration. Nonetheless, the between-group difference in live birth rate after frozen versus fresh embryo transfer was greater in women with progesterone concentrations ≥1.14 ng/ml (52.7% versus 37.3%, odds ratio (OR) 1.88, 95% confidence interval (CI) 1.55-2.27, P = 7.89 × 10 -11 ) than in women with progesterone concentrations <1.14 ng/ml (53.3% versus 48.1%, OR 1.23, 95% CI 1.08-1.41, P = 0.002). In women with progesterone concentration ≥1.14 ng/ml, frozen embryo transfer also resulted in higher rates of conception and clinical pregnancy than fresh embryo transfer.
CONCLUSION
In women with normal or high ovarian response, a freeze-only strategy resulted in a higher live birth rate than fresh embryo transfer, irrespective of progesterone concentration. Moreover, women with progesterone concentration ≥1.14 ng/ml may benefit more from a freeze-only strategy.",2020,"In women with progesterone concentration ≥1.14 ng/ml, frozen embryo transfer also resulted in higher rates of conception and clinical pregnancy than fresh embryo transfer.
","['women with progesterone concentration ≥1.14', '1508 women with polycystic ovary syndrome, 2157 ovulatory women who underwent cleavage-stage embryo transfer and 1650 ovulatory women who underwent single blastocyst transfer', 'women with normal or high ovarian response']","['frozen or fresh embryo transfer', 'freeze-only strategy versus fresh embryo transfer', 'elective frozen versus fresh embryo transfer']","['rates of conception and clinical pregnancy', 'live birth rate after the initial embryo transfer', 'live birth rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]",2157.0,0.295536,"In women with progesterone concentration ≥1.14 ng/ml, frozen embryo transfer also resulted in higher rates of conception and clinical pregnancy than fresh embryo transfer.
","[{'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250001, China; Department of Obstetrics and Gynecology, Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250000, China.'}, {'ForeName': 'Shigang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250001, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of Qingdao University, Qingdao 266003, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250001, China.'}, {'ForeName': 'Daimin', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'School of Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China. Electronic address: sdweidaimin@163.com.'}, {'ForeName': 'Shiqian', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250001, China. Electronic address: r370112@126.com.'}, {'ForeName': 'Zi-Jiang', 'Initials': 'ZJ', 'LastName': 'Chen', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250001, China; School of Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven CT 06520, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey PA 17033, USA.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.04.021']
1121,32602966,Effect of combined physical training on cognitive function in people with epilepsy: Results from a randomized controlled trial.,"OBJECTIVE
To examine the effect of 12-week exercise program on cognitive function in people with epilepsy.
METHODS
Twenty-one physically inactive subjects were randomized into two groups: the exercise group (EG) or the control group (CG). EG performed 12 weeks of combined physical training. CG was advised to maintain usual daily activities. EG received a structured, individually supervised exercise program with two 60-minute sessions per week. Each session included warmup (5-minutes), aerobic (15-20 minutes at 14-17 on Borg scale), strength (2-3 sets, 10-15 repetitions), and 5-minute active stretches. Sociodemographic characteristics, clinical information, memory (Digit Span Test [DST]), executive function (Trail Making Test [TMT] A and B), Stroop Color and Word Test, a verbal fluency task, global cognitive function (Montreal Cognitive Assessment [MoCA]), anthropometric measurements (weight, height, and hip and waist circumferences), cardiorespiratory fitness (maximal oxygen consumption [VO 2 max]), and strength (dynamometer) were measured at baseline and after the 12-week intervention.
RESULTS
Exercise decreased time spent on TMT-A from baseline to postintervention (difference = -7.9 seconds, 95% confidence interval [CI] = -14.5 to -1.3, P = .023). EG improved total number of words on the verbal fluency task after intervention (difference = 8.1 words, 95% CI = 3.0 to 13.2, P = .002). EG also improved the score on MoCA at 1.7 (95% CI = 0.1 to 3.3, P = .043) points. We observed a 22.4% (95% CI = 13.1 to 31.6, P = .021) improvement in executive function in EG. No effect of group, time, or group × time was observed on any other cognitive test. Changes in VO 2 max were negatively associated with changes in performance on DST (r = -.445, P = .049) and overall memory score (r = -.544, P = .042).
SIGNIFICANCE
This randomized controlled trial provided the first evidence that combined physical training improves executive function in adults with epilepsy, showing main improvements in attention and language tasks. Physical exercise should be encouraged for people with epilepsy to reduce the burden on cognitive function associated with this disease.",2020,"EG improved total number of words on the verbal fluency task after intervention (difference = 8.1 words, 95% CI = 3.0 to 13.2, P = .002).","['people with epilepsy', 'Twenty-one physically inactive subjects', 'adults with epilepsy']","['exercise group (EG) or the control group (CG', 'Physical exercise', 'exercise program', 'TMT', 'combined physical training', 'CG']","['score on MoCA', 'time spent on TMT', 'Stroop Color and Word Test, a verbal fluency task, global cognitive function (Montreal Cognitive Assessment [MoCA]), anthropometric measurements (weight, height, and hip and waist circumferences), cardiorespiratory fitness (maximal oxygen consumption [VO 2 max]), and strength (dynamometer', 'executive function', 'cognitive function', 'overall memory score', 'performance on DST', 'total number of words on the verbal fluency task', 'Sociodemographic characteristics, clinical information, memory (Digit Span Test [DST]), executive function (Trail Making Test', 'attention and language tasks']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023008', 'cui_str': 'Language'}]",21.0,0.0861104,"EG improved total number of words on the verbal fluency task after intervention (difference = 8.1 words, 95% CI = 3.0 to 13.2, P = .002).","[{'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Feter', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutritional Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Alt', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'César A', 'Initials': 'CA', 'LastName': 'Häfele', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'da Silva', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Airton J', 'Initials': 'AJ', 'LastName': 'Rombaldi', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}]",Epilepsia,['10.1111/epi.16588']
1122,32607803,Perfusion in hand arthritis on dynamic contrast-enhanced computed tomography: a randomized prospective study using MRI as a standard of reference.,"OBJECTIVE
To evaluate the performance of dynamic contrast-enhanced CT (DCE-CT) in detecting and quantitatively assessing perfusion parameters in patients with arthritis of the hand compared with dynamic contrast-enhanced MRI (DCE-MRI) as a standard of reference.
MATERIALS AND METHODS
In this IRB-approved randomized prospective single-centre study, 36 consecutive patients with suspected rheumatoid arthritis underwent DCE-CT (320-row, tube voltage 80 kVp, tube current 8.25 mAs) and DCE-MRI (1.5 T) of the hand. Perfusion maps were calculated separately for mean transit time (MTT), time to peak (TTP), relative blood volume (rBV), and relative blood flow (rBF) using four different decomposition techniques. Region of interest (ROI) analysis was performed in metacarpophalangeal joints II-V and in the wrist. Pairs of perfusion parameters in DCE-CT and DCE-MRI were compared using a two-tailed t test for paired samples and interpreted for effect size (Cohen's d). According to the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) scoring results, differentiation of synovitis-positive and synovitis-negative joints with both modalities was assessed with the independent t test.
RESULTS
The two modalities yielded similar perfusion parameters. Identified differences had small effects (d 0.01-0.4). DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation. The total dose-length product (DLP) was 48 mGy*cm with an estimated effective dose of 0.038 mSv.
CONCLUSION
DCE-CT is a promising imaging technique in arthritis. In patients with a contraindication to MRI or when MRI is not available, DCE-CT is a suitable alternative to detect and assess arthritis.",2021,DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation.,"['36 consecutive patients with suspected rheumatoid arthritis underwent', 'patients with arthritis of the hand compared with dynamic contrast-enhanced MRI (DCE-MRI']","['dynamic contrast-enhanced computed tomography', 'dynamic contrast-enhanced CT (DCE-CT', 'DCE-CT', 'DCE-CT (320-row, tube voltage 80\xa0kVp, tube current 8.25\xa0mAs) and DCE-MRI']","['total dose-length product (DLP', 'mean transit time (MTT), time to peak (TTP), relative blood volume (rBV), and relative blood flow (rBF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0409208', 'cui_str': 'Arthritis of hand'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",36.0,0.0411065,DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation.,"[{'ForeName': 'Sevtap Tugce', 'Initials': 'ST', 'LastName': 'Ulas', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Kay Geert', 'Initials': 'KG', 'LastName': 'Hermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Makowski', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Biesen', 'Affiliation': 'Department of Rheumatology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Proft', 'Affiliation': 'Department of Rheumatology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Schilling', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany. torsten.diekhoff@charite.de.'}]",Skeletal radiology,['10.1007/s00256-020-03526-5']
1123,32620300,Free flap donor site during early review consultations: is it really an issue?,"Donor site complications, following microvascular free tissue transfer, can limit recovery in patients treated for head and neck cancer, with a curative intent. The Patient Concerns Inventory (PCI-HN) is a prompt list that provides patients with repeated opportunities to raise issues they feel are important and want to discuss. Here, we look at baseline results from a cluster preference randomised control trial with consultants either ""using"" or ""not using"" the PCI package in clinic to identify patient concerns. UWQOL results were presented from 67 consecutive patients having reconstruction with free tissue transfer and PCI results from 25 of these patients in the PCI arm of the trial. During early review consultations patients most wanted to discuss issues related to dental health, dry mouth, and chewing. Donor site morbidity, in our patient sample, did not appear to be an issue that patients wanted to discuss.",2020,"Donor site complications, following microvascular free tissue transfer, can limit recovery in patients treated for head and neck cancer, with a curative intent.","['patients treated for head and neck cancer, with a curative intent', '67 consecutive patients having reconstruction with free tissue transfer and PCI results from 25 of these patients in the PCI arm of the trial']","['using"" or ""not using"" the PCI package']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]",[],67.0,0.072294,"Donor site complications, following microvascular free tissue transfer, can limit recovery in patients treated for head and neck cancer, with a curative intent.","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Kanatas', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology and Leeds Dental Institute. Electronic address: a.kanatas@doctors.org.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Director Astraglobe Ltd, Congleton, Cheshire, UK. Electronic address: astraglobeltd@btconnect.com.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Evidence-Based Practice Research Centre (EPRC), Faculty of Health and Social Care, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK; Consultant Regional Maxillofacial Unit, University Hospital Aintree, Liverpool, L9 1AE, UK. Electronic address: simonn.rogers@aintree.nhs.uk.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.06.007']
1124,32627890,"Impaired pulmonary gas exchange efficiency, but normal pulmonary artery pressure increases, with hypoxia in men and women with a patent foramen ovale.","NEW FINDINGS
What is the central question of this study? Do individuals with a patent foramen ovale (PFO + ) have a larger alveolar-to-arterial difference in P O 2 ( A - a D O 2 ) than those without (PFO - ) and/or an exaggerated increase in pulmonary artery systolic pressure (PASP) in response to hypoxia? What is the main finding and its importance? PFO + had a greater A - a D O 2 while breathing air, 16% and 14% O 2 , but not 12% or 10% O 2 . PASP increased equally in hypoxia between PFO + and PFO - . These data suggest that PFO + may not have an exaggerated acute increase in PASP in response to hypoxia.
ABSTRACT
Patent foramen ovale (PFO) is present in 30-40% of the population and is a potential source of right-to-left shunt. Accordingly, those with a PFO (PFO + ) may have a larger alveolar-to-arterial difference in P O 2 ( A - a D O 2 ) than those without (PFO - ) in normoxia and with mild hypoxia. Likewise, PFO is associated with high-altitude pulmonary oedema, a condition known to have an exaggerated pulmonary pressure response to hypoxia. Thus, PFO + may also have exaggerated pulmonary pressure increases in response to hypoxia. Therefore, the purposes of the present study were to systematically determine whether or not: (1) the A - a D O 2 was greater in PFO + than in PFO - in normoxia and mild to severe hypoxia and (2) the increase in pulmonary artery systolic pressure (PASP) in response to hypoxia was greater in PFO + than in PFO - . We measured arterial blood gases and PASP via ultrasound in healthy PFO + (n = 15) and PFO - (n = 15) humans breathing air and 30 min after breathing four levels of hypoxia (16%, 14%, 12%, 10% O 2 , randomized and balanced order) at rest. The A - a D O 2 was significantly greater in PFO + compared to PFO - while breathing air (2.1 ± 0.7 vs. 0.4 ± 0.3 Torr), 16% O 2 (1.8 ± 1.2 vs. 0.7 ± 0.8 Torr) and 14% O 2 (2.3 ± 1.2 vs. 0.7 ± 0.6 Torr), but not 12% or 10% O 2 . We found no effect of PFO on PASP at any level of hypoxia. We conclude that PFO influences pulmonary gas exchange efficiency with mild hypoxia, but not the acute increase in PASP in response to hypoxia.",2020,"PFO+ had a greater A-aDO 2 while breathing air, 16% and 14%, but not 12% or 10% O 2 .","['n\xa0=\xa015', 'men and women with a patent foramen ovale', 'individuals with a patent foramen ovale (PFO', 'healthy PFO+ (n\xa0=\xa015) and PFO']","['PFO (PFO', 'PFO', 'PASP']","['pulmonary artery systolic pressure (PASP', 'normal pulmonary artery pressure increases with hypoxia', 'arterial blood gases and PASP via ultrasound', 'PFO']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016522', 'cui_str': 'Patent foramen ovale'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0048701', 'cui_str': '4-S-(propionic acid)sulfidocyclophosphamide'}]","[{'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure'}, {'cui': 'C0048701', 'cui_str': '4-S-(propionic acid)sulfidocyclophosphamide'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",,0.0249063,"PFO+ had a greater A-aDO 2 while breathing air, 16% and 14%, but not 12% or 10% O 2 .","[{'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Duke', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Beasley', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Julia P', 'Initials': 'JP', 'LastName': 'Speros', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Elliott', 'Affiliation': 'VA Portland Health Care System, Portland, OR, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Laurie', 'Affiliation': 'KBR, Cardiovascular and Vision Laboratory, NASA Johnson Space Center, Houston, TX, USA.'}, {'ForeName': 'Randall D', 'Initials': 'RD', 'LastName': 'Goodman', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Eben', 'Initials': 'E', 'LastName': 'Futral', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Jerold A', 'Initials': 'JA', 'LastName': 'Hawn', 'Affiliation': 'Oregon Heart and Vascular Institute, Springfield, OR, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Lovering', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR, USA.'}]",Experimental physiology,['10.1113/EP088750']
1125,32627975,Effect of Chin-down-plus-larynx-tightening maneuver on swallowing function after minimally invasive esophagectomy: A randomized controlled trail.,"BACKGROUND
The incidence of swallowing abnormality was high after minimally invasive esophagectomy (MIE) for esophageal cancer (EC). Few reports, however, focused on interventions for dysphagia after esophagectomy.
AIM
The purpose of this research was to estimate the effect of Chin-down-plus-larynx-tightening maneuver on swallowing function for patients receiving esophagectomy.
METHOD
This was a 2-arm, parallel-group, single-blind randomized clinical trial, performed in patients suffered from EC from November 2018 to January 2020. Patients were randomly assigned to the intervention group (IG) or the control group (CG). The participants in CG received routine care, and the IG received Chin-down-plus-larynx-tightening maneuver during feeding. The incidence of choking cough, swallowing function, and dietary outcomes were evaluated before and after intervention for 7 days.
RESULTS
A total of 237 EC cases were enrolled and randomized to the IG (n = 118) or CG (n = 119). There was no significant difference between the two groups in terms of demographic and clinical characteristics. Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P < .001). The analysis showed that the participants in the IG compared with the CG have more total caloric intake of 24 hours and higher K/R (the ratio of calories oral achieved to total calories required of body) significantly from D1 to D7 of intervention (P < .05).
CONCLUSION
The findings suggest that the Chin-down-plus-larynx-tightening maneuver can improve swallowing function recovery and oral total food intake and calories in EC patients undergoing MIE.",2020,"Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P ","['patients receiving esophagectomy', 'A total of 237 EC cases', 'EC patients undergoing MIE', 'patients suffered from EC from November 2018 to January 2020', 'after minimally invasive esophagectomy']","['Chin-down-plus-larynx-tightening maneuver during feeding', 'Chin-down-plus-larynx-tightening maneuver', 'minimally invasive esophagectomy (MIE', 'CG', 'intervention group (IG) or the control group (CG']","['incidence of choking cough, swallowing function, and dietary outcomes', 'swallowing function', 'total caloric intake', 'Postoperative choking cough', 'swallowing function recovery and oral total food intake and calories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",237.0,0.0724695,"Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P ","[{'ForeName': 'Funa', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Nursing Department, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Peinan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xianben', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Nursing Department, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}]",Cancer medicine,['10.1002/cam4.3280']
1126,32607081,Residual Right Coronary Artery Stenosis after Left Main Coronary Artery Intervention Increased the 30-Day Cardiovascular Death and 3-Year Right Coronary Artery Revascularization Rate.,"Background
The outcomes of patients with concomitant left main coronary artery (LMCA) and right coronary artery (RCA) diseases are reportedly worse than those with only LMCA disease. To date, only few studies have investigated the clinical impact of percutaneous coronary intervention (PCI) on RCA stenosis during the same hospitalization, in which LMCA disease was treated. This study was aimed at comparing the outcomes between patients with and without right coronary artery intervention during the same hospital course for LMCA intervention.
Methods and Results
From a total of 776 patients who were undergoing PCI to treat LMCA disease, 235 patients with concomitant RCA significant stenosis (more than 70% stenosis) were enrolled. The patients were divided into two groups: 174 patients received concomitant PCI for RCA stenosis during the same hospitalization, in which LMCA disease was treated, and 61 patients did not receive PCI for RCA stenosis. Patients without intervention to the right coronary artery had higher 30-day cardiovascular mortality rates and 3-year RCA revascularization rates compared to those with right coronary artery intervention. Patients without RCA intervention at the same hospitalization did not increase the 30-day total death, 3-year myocardial infarction rate, 3-year cardiovascular death, and 3-year total death.
Conclusions
In patients with LM disease and concomitant above or equal to 70% RCA stenosis, PCI for RCA lesion during the same hospitalization is recommended to reduce the 30-day cardiovascular death and 3-year RCA revascularization rate.",2020,Patients without intervention to the right coronary artery had higher 30-day cardiovascular mortality rates and 3-year RCA revascularization rates compared to those with right coronary artery intervention.,"['776 patients who were undergoing PCI to treat LMCA disease, 235 patients with concomitant RCA significant stenosis (more than 70% stenosis) were enrolled', 'patients with concomitant left main coronary artery (LMCA) and right coronary artery (RCA) diseases are reportedly worse than those with only LMCA disease', 'patients with and without right coronary artery intervention during the same hospital course for LMCA intervention']","['percutaneous coronary intervention (PCI', 'concomitant PCI for RCA stenosis', 'RCA intervention']","['30-day cardiovascular mortality rates and 3-year RCA revascularization rates', '30-day cardiovascular death and 3-year RCA revascularization rate', '30-day total death, 3-year myocardial infarction rate, 3-year cardiovascular death, and 3-year total death', '30-Day Cardiovascular Death and 3-Year Right Coronary Artery Revascularization Rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1261082', 'cui_str': 'Left coronary artery structure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C3267166', 'cui_str': 'Right coronary artery stenosis'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",776.0,0.0310231,Patients without intervention to the right coronary artery had higher 30-day cardiovascular mortality rates and 3-year RCA revascularization rates compared to those with right coronary artery intervention.,"[{'ForeName': 'Chien-Ho', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Shaur-Zheng', 'Initials': 'SZ', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Shu-Kai', 'Initials': 'SK', 'LastName': 'Hsueh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Jung', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-I', 'Initials': 'CI', 'LastName': 'Cheng', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}]",Journal of interventional cardiology,['10.1155/2020/4587414']
1127,32615487,A quasi-cluster randomized controlled trial of a classroom-based mental health literacy educational intervention to promote knowledge and help-seeking/helping behavior in adolescents.,"INTRODUCTION
School-based education is a potentially effective approach for improving mental health literacy (MHL) in adolescents. This study evaluated the effects of the ""Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL in adolescents in a quasi-cluster randomized controlled trial.
METHODS
A total of 975 high school first graders (age 15-16) in Japan were allocated to classes such that gender and academic achievement ratios were almost equivalent at the time of admission to the high school. They were assigned at the class level to the SMHLP (n = 364 from 10 classes) or a control group (n = 611 from 17 classes). The program consisted of a 50-minute session and was delivered by a school teacher. The students completed a self-report questionnaire at 3 time points: pre-, (immediately) post- and 2-month follow-up. Outcomes included ""Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers"". Mixed effects modeling was employed for analyses.
RESULTS
Scores of all outcomes were significantly improved in the intervention group compared to the control group post-intervention (p < .001). These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05). Questionnaire scores did not differ between groups at baseline.
CONCLUSIONS
The effect of the SMHLP was confirmed in grade 10 students. Brief, yet effective programs can be a viable option to promote understanding of mental health problems and have the potential to be incorporated into regular school curriculum. "".",2020,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"['A total of 975 high school first graders (age 15-16) in Japan', 'grade 10 students', 'adolescents']","['SMHLP', 'classroom-based mental health literacy educational intervention', 'Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL']","['Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers', 'Questionnaire scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0024851', 'cui_str': 'Marshall Islands'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023865', 'cui_str': 'Literacy Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",975.0,0.047281,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: yama-s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8553, Japan. Electronic address: ojio@ncnp.go.jp.'}, {'ForeName': 'Jerome Clifford', 'Initials': 'JC', 'LastName': 'Foo', 'Affiliation': 'Central Institute of Mental Health, Department of Genetic Epidemiology in Psychiatry, Medical Faculty Mannheim, University of Heidelberg, J5 68159, Mannheim, Germany. Electronic address: jeromefoo@gmail.com.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Michigami', 'Affiliation': 'Saitama Prefectural Soka Higashi High School, 1110-1 Kakinoki-cho, Soka, Saitama, 340-0001, Japan. Electronic address: michigami@msj.biglobe.ne.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Usami', 'Affiliation': 'Center for Research and Development on Transition from Secondary to Higher Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: usami_s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Taruto', 'Initials': 'T', 'LastName': 'Fuyama', 'Affiliation': 'Graduate School of Film and New Media, Tokyo University of the Arts, 4-23, Kaigan-dori, Naka-ku, Yokohama, Kanagawa, 231-0002, Japan. Electronic address: fuyan@taruto.com.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Onuma', 'Affiliation': 'Department of Health and Nutrition, Laboratory of Practical Yogo Science, Kagawa Education Institute of Nutrition, 3-9-21 Chiyoda, Sakado, Saitama, 350-0288, Japan. Electronic address: kokumichan@gmail.com.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Oshima', 'Affiliation': 'Office for Mental Health Support, Division for Counseling and Support, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: rxg01737@qg8.so-net.ne.jp.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Tokyo Metropolitan Institute of Medical Science, 2-1-6, Kamikitazawa, Setagaya-ku, Tokyo, 156-8506, Japan. Electronic address: sandou-tky@umin.ac.jp.'}, {'ForeName': 'Fumiharu', 'Initials': 'F', 'LastName': 'Togo', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: tougou@p.u-tokyo.ac.jp.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: psytokyo577@gmail.com.'}]",Journal of adolescence,['10.1016/j.adolescence.2020.05.002']
1128,32618258,Impact of Different Strategies for Delivering Supplemental Zinc on Selected Fecal Markers of Environmental Enteric Dysfunction among Young Laotian Children: A Randomized Controlled Trial.,"The objective of this study was to assess the impact of different strategies for delivering supplemental zinc on fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL) among young Laotian children. In a double-blind controlled trial, children aged 6-23 months were randomized to receive either daily preventive zinc (PZ) tablets (7 mg/day), daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment (20 mg/day for 10 days), or daily placebo powder and followed for ∼36 weeks. Stool samples were collected at baseline and endline. Fecal MPO, NEO, and CAL concentrations were determined in a randomly selected subsample of 720 children using commercially available ELISA kits. At baseline, the mean age was 14.1 ± 4.9 months and prevalence of stunting was 39%. The endline prevalence of stunting was 43%; there was no overall treatment effect on physical growth in the parent trial. At endline, the mean (95% CI) MPO in the PZ group was 1,590 [1,396; 1,811] ng/mL and did not differ from that in the MNP (1,633 [1,434; 1,859] ng/mL), TZ (1,749 [1,535; 1,992] ng/mL), and control (1,612 [1,415; 1,836] ng/mL) groups ( P = 0.749). Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P = 0.226 and 0.229, respectively). In this population, the provision of PZ or TZ supplements or MNP had no impact on growth or environmental enteric dysfunction (EED) as assessed by fecal MPO, NEO, and CAL. Additional research is needed to better understand the etiology and proposed mechanisms of EED pathogenesis.",2020,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P = 0.226 and 0.229, respectively).","['young Laotian children', 'Young Laotian Children', 'children aged 6-23 months']","['daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment', 'placebo powder', 'daily preventive zinc (PZ) tablets', 'TZ', 'PZ or TZ supplements or MNP', 'MNP']","['prevalence of stunting', 'fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL', 'physical growth', 'Fecal MPO, NEO, and CAL concentrations', 'growth or environmental enteric dysfunction (EED', 'NEO and CAL concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",720.0,0.568268,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P = 0.226 and 0.229, respectively).","[{'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Helen Keller International, Washington, District of Columbia.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Public Health Program, College of Health and Human Services, Missouri State University, Springfield, Missouri.'}, {'ForeName': 'Somphou', 'Initials': 'S', 'LastName': 'Sayasone', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0106']
1129,32627599,A placebo-controlled trial to investigate the safety and efficacy of Penicillin G/Hydrocortisone in patients with ALS (PHALS trial).,"OBJECTIVE
A recent case-series described patients with ALS to improve and/or stabilize after treatment with intravenous high-dose Penicillin G/Hydrocortisone (PenGH). In this study, we determine the safety and efficacy of intravenous PenGH versus placebo in combination with riluzole in patients with ALS.
METHODS
Patients diagnosed with ALS according to the El Escorial criteria were randomized double-blind to four quarterly cycles of 21 d of intravenous PenGH or placebo in a 5:3 ratio. The primary outcome was change from baseline to week 48 in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R). Secondary outcomes were lung function, muscle strength, plasma creatinine, clinical stage, gastrostomy placement, quality of life and occurrence of adverse of events.
RESULTS
In total, 16 patients were randomized (10 PenGH and 6 placebo), of which 6 (40%) completed the study. Patients treated with PenGH progressed with 2.2 (95% CI 1.1-3.3) ALSFRS-R points per month and PenGH treatment did not halt disease progression ( p = 0.002). No significant differences were found between PenGH or placebo (mean difference 0.5, 95% CI -1.01 to ∞, p = 0.28). Although PenGH was well-tolerated, 6 patients (38%, 3 in each arm) had thrombotic complications due to the intravenous administration method.
CONCLUSIONS
Treatment with PenGH does not halt disease or reverse progression in patients with ALS and showed no statistical difference with those who received placebo. Prolonged intravenous administration therapies may inflate thrombosis risk.",2020,Conclusions : Treatment with PenGH does not halt disease or reverse progression in patients with ALS and showed no statistical difference with those who received placebo.,"['16 patients were randomized (10 PenGH and 6', 'Patients diagnosed with ALS according to the El Escorial criteria', 'patients with ALS (PHALS trial', 'patients with ALS']","['riluzole', 'Penicillin G/Hydrocortisone (PenGH', 'Penicillin G/Hydrocortisone', 'intravenous PenGH or placebo', 'PenGH', 'intravenous PenGH versus placebo', 'placebo']","['disease progression', 'lung function, muscle strength, plasma creatinine, clinical stage, gastrostomy placement, quality of life and occurrence of adverse of events', 'safety and efficacy', 'change from baseline to week 48 in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R', 'thrombotic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0030827', 'cui_str': 'Penicillin G'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1278055', 'cui_str': 'Plasma creatinine measurement'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0017196', 'cui_str': 'Gastrostomy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",16.0,0.607565,Conclusions : Treatment with PenGH does not halt disease or reverse progression in patients with ALS and showed no statistical difference with those who received placebo.,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Van Es', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Ruben P A', 'Initials': 'RPA', 'LastName': 'Van Eijk', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Tommy M', 'Initials': 'TM', 'LastName': 'Bunte', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Van Den Berg', 'Affiliation': 'Department of Neurology, UMC Utrecht Brain Center, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]",Amyotrophic lateral sclerosis & frontotemporal degeneration,['10.1080/21678421.2020.1788093']
1130,32622768,A Novel Penile Splint as Early Traction Therapy After Grafting Techniques for Peyronie's Disease.,"BACKGROUND
Some studies showed encouraging results on the efficacy and safety of penile traction therapy after Peyronie's disease (PD) surgery. The early traction therapy (ETT) could be an effective and safe approach to minimize penile shortening in patients undergoing PD surgery.
AIM
To evaluate the feasibility, efficacy, and safety of a novel penile splint as ETT in patients with PD undergoing grafting techniques.
METHODS
Patients with PD underwent plaque incision and grafting technique; at the end of the procedure, a novel penile splint (ETT) was applied to all patient. The device consisted of 2 10CH intubating stylets, self-adapted to each patient, that kept the penis stretched with the aid of non-absorbable sutures. The total expense for the materials needed to build each penile splint was less than 15 euros. This active traction was maintained for 1-3 weeks; then, we removed the stitches leaving the device on-site for a passive traction. Within 3-4 weeks from surgery, the penile splint was replaced by a standard penile traction device.
OUTCOMES
The main outcomes evaluated at 6 months included stretched penile length (SPL), penile curvature, International Index of Erectile Function-erectile function (IIEF-EF) domain, patient satisfaction, and time to first satisfactory sexual intercourse.
RESULTS
A total of 46 patients were enrolled. The median preoperative IIEF-EF, penile curvature, and SPL were 27 points, 70°, and 13 cm, respectively. The median follow-up was 15 months. The median postoperative IIEF-EF was 25 points (P < .001). The median residual penile curvature was 10° (P < .001). The median postoperative SPL was 13 cm (P = .269). 8 patients (17.4%) lost 1 cm of SPL; no shortening greater than 1 cm was recorded. The median time to first satisfactory sexual intercourse and patient satisfaction score was 6 weeks and 9 points, respectively.
CLINICAL IMPLICATIONS
Our results could pave the way for a new line of research, which in turn could lead to an improvement in the postoperative management of the patient undergoing surgery for PD.
STRENGTH & LIMITATIONS
This is the first study evaluating the ETT after PD surgery. The main limitation of this study is the lack of a randomized control group. Other weaknesses are the small sample size and the short follow-up time.
CONCLUSION
Our novel penile splint is inexpensive, easy to assemble, and adaptable to the patient. ETT using this novel device, followed by standard traction therapy, seems to be feasible, effective, and safe. Fernández-Pascual E, Manfredi C, Cocci A, et al. A Novel Penile Splint as Early Traction Therapy After Grafting Techniques for Peyronie's Disease. J Sex Med 2020;17:1819-1824.",2020,The median postoperative IIEF-EF was 25 points (P < .001).,"[""after Peyronie's disease (PD) surgery"", 'Patients with PD underwent', 'patients undergoing PD surgery', 'patient undergoing surgery for PD', '46 patients were enrolled', 'patients with PD undergoing grafting techniques']","['novel penile splint as ETT', 'early traction therapy (ETT', 'plaque incision and grafting technique', 'penile traction therapy', 'novel penile splint (ETT', 'Novel Penile Splint as Early Traction Therapy']","['median preoperative IIEF-EF, penile curvature, and SPL', 'median postoperative SPL', 'efficacy and safety', 'median time to first satisfactory sexual intercourse and patient satisfaction score', 'feasibility, efficacy, and safety', 'median postoperative IIEF-EF', 'stretched penile length (SPL), penile curvature, International Index of Erectile Function-erectile function (IIEF-EF) domain, patient satisfaction, and time to first satisfactory sexual intercourse', 'median residual penile curvature']","[{'cui': 'C0030848', 'cui_str': 'Induratio penis plastica'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2938970', 'cui_str': 'Penile curvature'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",46.0,0.0400712,The median postoperative IIEF-EF was 25 points (P < .001).,"[{'ForeName': 'Esaú', 'Initials': 'E', 'LastName': 'Fernández-Pascual', 'Affiliation': 'Department of Urology, Hospital Universitario La Paz, Madrid, Spain; LYX Institute of Urology, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Manfredi', 'Affiliation': 'Urology Unit, Department of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples ""Federico II"", Naples, Italy. Electronic address: manfredi.celeste@gmail.com.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cocci', 'Affiliation': 'Department of Urology, University of Florence, Careggi Hospital, Florence, Italy.'}, {'ForeName': 'Luis Miguel', 'Initials': 'LM', 'LastName': 'Quintana Franco', 'Affiliation': 'Department of Urology, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'María Alejandra', 'Initials': 'MA', 'LastName': 'Egui Rojo', 'Affiliation': 'Department of Urology, Hospital Universitario HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Carballido Rodríguez', 'Affiliation': 'Department of Urology, Hospital Universitario Puerta De Hierro-Majadahonda, Madrid, Spain.'}, {'ForeName': 'Juan Ignacio', 'Initials': 'JI', 'LastName': 'Martínez-Salamanca', 'Affiliation': 'LYX Institute of Urology, Universidad Francisco de Vitoria, Madrid, Spain; Department of Urology, Hospital Universitario Puerta De Hierro-Majadahonda, Madrid, Spain.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.05.009']
1131,32603714,Deterioration of Nighttime Respiratory Mechanics in COPD: Impact of Bronchodilator Therapy.,"BACKGROUND
COPD is associated with nighttime respiratory symptoms, poor sleep quality, and increased risk of nocturnal death. Overnight deterioration of inspiratory capacity (IC) and FEV 1 have been documented previously. However, the precise nature of this deterioration and mechanisms by which evening bronchodilation may mitigate this occurrence have not been studied.
RESEARCH QUESTION
What is the effect of evening dosing of dual, long-acting bronchodilation on detailed nocturnal respiratory mechanics and inspiratory neural drive (IND)?
STUDY DESIGN AND METHODS
A double-blind, randomized, placebo-controlled crossover study assessed the effects of evening long-acting bronchodilation (aclidinium bromide/formoterol fumarate dihydrate: 400/12 μg) or placebo on morning trough IC (12 h after the dose; primary outcome) and serial overnight measurements of spirometry, dynamic respiratory mechanics, and IND (secondary outcomes). Twenty participants with COPD (moderate/severe airway obstruction and lung hyperinflation) underwent serial measurements of IC, spirometry, breathing pattern, esophageal and transdiaphragmatic pressures, and diaphragm electromyography (maximum diaphragmatic electromyography percent; IND) at 6 time points from 0 to 12 h after the dose and compared with sleeping IND.
RESULTS
Compared with placebo, evening bronchodilation was not associated with increased morning trough IC 12 h after the dose (P = .48); however, nadir IC (lowest IC, independent of time), peak IC, area under the curve for 12 h after the dose, and IC for 10 h after the dose were improved (P < .05). During placebo, total airways resistance, lung hyperinflation, IND, and tidal esophageal and transdiaphragmatic pressure swings all increased significantly overnight compared with baseline evening values; however, each of these parameters improved with bronchodilation treatment (P < .05) with no change in ventilation or breathing pattern.
INTERPRETATION
Respiratory mechanics significantly deteriorated at night during placebo. Although the morning trough IC was unchanged, evening bronchodilator treatment was associated consistently with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02429765.",2020,"While morning trough IC was unchanged, evening bronchodilator treatment was consistently associated with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo.","['Chronic Obstructive Pulmonary Disease (COPD', '20 participants with COPD (moderate/severe airway obstruction and lung hyperinflation', 'Chronic Obstructive Pulmonary Disease']","['evening long-acting bronchodilators (BD; aclidinium bromide/formoterol fumarate dihydrate', 'placebo (PL', 'dual, long-acting bronchodilators', 'placebo']","['serial overnight measurements of spirometry, dynamic respiratory mechanics and IND (secondary outcomes', 'dynamic respiratory mechanics and inspiratory neural drive', 'morning trough IC', 'Overnight deterioration of inspiratory capacity (IC) and forced expiratory volume', 'nadir IC (lowest IC, independent of time), peak IC, area under the curve', 'IC, spirometry, breathing pattern, esophageal and transdiaphragmatic pressures and diaphragm electromyography (EMGdi %max ; IND', 'total airways resistance, lung hyperinflation, IND, and tidal esophageal and transdiaphragmatic pressure swings', 'detailed nocturnal respiratory mechanics and inspiratory neural drive (IND']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C2699758', 'cui_str': 'aclidinium bromide'}, {'cui': 'C1579393', 'cui_str': 'Formoterol fumarate dihydrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0232024', 'cui_str': 'Total airway resistance'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",20.0,0.596271,"While morning trough IC was unchanged, evening bronchodilator treatment was consistently associated with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo.","[{'ForeName': 'Nicolle J', 'Initials': 'NJ', 'LastName': 'Domnik', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Ayoo', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Taylor', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Di Luch', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Vincent', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Amany F', 'Initials': 'AF', 'LastName': 'Elbehairy', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Department of Chest Diseases, Faculty of Medicine, Alexandria University, Alexandria, Egypt.""}, {'ForeName': 'Sophie J', 'Initials': 'SJ', 'LastName': 'Crinion', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada; Sleep Disorders Laboratory, Kingston Health Sciences Centre, Kingston, Canada.""}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Driver', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada; Sleep Disorders Laboratory, Kingston Health Sciences Centre, Kingston, Canada.""}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'Neder', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada. Electronic address: odonnell@queensu.ca.""}]",Chest,['10.1016/j.chest.2020.06.033']
1132,32604235,"A Prospective, Split-Face, Randomized Study Comparing Picosecond to Q-Switched Nd: YAG Laser for Treatment of Epidermal and Dermal Pigmented Lesions in Asians.","BACKGROUND
Whether picosecond lasers outperform Q-switched lasers in treating pigmented lesions has not been clearly evaluated.
OBJECTIVE
To compare the efficacy and safety of picosecond and Q-switched lasers in treating epidermal and dermal pigmented lesions in Asians.
METHODS
Eight subjects with lentigines and 6 subjects with acquired bilateral nevus of Ota-like macules were enrolled. Subjects was randomly treated with a picosecond laser on one side of the face and a Q-switched laser on the other side. Subjective assessments on pigment clearance, and adverse effect were obtained at Weeks 0, 4, 12, and 24 after the final treatment.
RESULTS
Clinical improvement differed between the 2 laser systems at Week 4 (p = .034), Week 12 (p = .039), and Week 24 (p = .027), with 85.7% of picosecond and 57.2% of Q-switched laser sites showing >50% improvement at 6 months. There was no significant difference in the incidence of side effect and healing time, but picosecond laser was significantly associated with a lower treatment discomfort (p = .05).
CONCLUSION
The picosecond laser seems to be more effective and better tolerated than Q-switched laser for the treatment of pigmented lesions in Asians.",2020,"RESULTS
Clinical improvement differed between the 2 laser systems at Week 4 (p = .034), Week 12 (p = .039), and Week 24 (p = .027), with 85.7% of picosecond and 57.2% of Q-switched laser sites showing >50% improvement at 6 months.","['Eight subjects with lentigines and 6 subjects with acquired bilateral nevus of Ota-like macules were enrolled', 'Epidermal and Dermal Pigmented Lesions in Asians', 'treating epidermal and dermal pigmented lesions in Asians']","['picosecond laser on one side of the face and a Q-switched laser on the other side', 'picosecond and Q-switched lasers', 'Picosecond to Q-Switched Nd: YAG Laser']","['incidence of side effect and healing time', 'efficacy and safety', 'Subjective assessments on pigment clearance, and adverse effect']","[{'cui': 'C0023321', 'cui_str': 'Lentigo'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027961', 'cui_str': 'Oculocutaneous melanocytic nevus'}, {'cui': 'C0332573', 'cui_str': 'Macule'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1956123', 'cui_str': 'Q-Switched Lasers'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",8.0,0.017196,"RESULTS
Clinical improvement differed between the 2 laser systems at Week 4 (p = .034), Week 12 (p = .039), and Week 24 (p = .027), with 85.7% of picosecond and 57.2% of Q-switched laser sites showing >50% improvement at 6 months.","[{'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Ungaksornpairote', 'Affiliation': '*All authors are affiliated with the Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': ''}, {'ForeName': 'Natchaya', 'Initials': 'N', 'LastName': 'Junsuwan', 'Affiliation': ''}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'All authors are affiliated with the Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002486']
1133,32617881,Priming Before In Vitro Maturation Cycles in Cancer Patients Undergoing Urgent Fertility Preservation: a Randomized Controlled Study.,"In vitro maturation (IVM) of oocytes retrieved at germinal vesicle stage, followed by vitrification of mature oocytes, has emerged as a fertility preservation (FP) option. This technique was first developed for patients with polycystic ovarian syndrome. In this population, providing LH activity prior to oocyte collection has been associated with better IVM outcomes. However, the benefit of this treatment in normo-ovulatory breast cancer (BC) patients undergoing IVM for FP purpose has never been investigated. To assess if the absence of therapeutic intervention prior to oocyte retrieval for IVM modifies IVM outcomes in BC patients undergoing urgent FP, we performed a non-inferiority, randomized controlled trial. The main outcome was the total number of mature oocytes obtained and cryopreserved after IVM. A total of 172 normo-ovulatory women, suffering from BC, 18 to 39 years of age received no injection or a subcutaneous injection of hCG or GnRH agonist (GnRHa) 36 h before oocytes retrieval according to randomized allocation. The total number of cryopreserved oocytes were 5.1 ± 3.8, 5.4 ± 3.8, and 6.0 ± 4.2 oocytes, respectively in the without, hCG and GnRHa groups. Mean differences were not significant between the three groups (- 0.5; CI 97.5% [- 2.03:1.02] and - 0.22; CI 97.5% [- 1.75:1.32], respectively). Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups. Our results are not conclusive enough to modify our practices and to stop administering hCG or GnRHa before IVM cycles for FP. The study was retrospectively registered to clinical trial (ID NCT03954197) in May 2019.",2020,"Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups.","['Cancer Patients', 'Undergoing Urgent Fertility Preservation', 'BC patients undergoing urgent FP', '172 normo-ovulatory women, suffering from BC, 18 to 39\xa0years of age received no injection or a subcutaneous injection of hCG or GnRH agonist (GnRHa) 36\xa0h before oocytes retrieval according to randomized allocation', 'patients with polycystic ovarian syndrome']",[],"['total number of cryopreserved oocytes', 'total number of mature oocytes obtained and cryopreserved after IVM']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1171194', 'cui_str': 'Fertility care'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]",,0.232947,"Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sonigo', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Le Conte', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Boubaya', 'Affiliation': 'Clinical Research Unit and Clinical Research Center, Avicenne Hospital, APHP, Bobigny, France.'}, {'ForeName': 'Haykanush', 'Initials': 'H', 'LastName': 'Ohanyan', 'Affiliation': 'Clinical Research Unit and Clinical Research Center, Avicenne Hospital, APHP, Bobigny, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Pressé', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'El Hachem', 'Affiliation': 'Department of Reproductive Medicine, Ovo Clinic, Montreal, Quebec, Canada; Department of Obstetrics and Gynecology, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cedrin-Durnerin', 'Affiliation': 'Department of Reproductive Medicine & Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Benoit', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sifer', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sermondade', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Grynberg', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France. michael.grynberg@aphp.fr.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00244-0']
1134,32627205,"Blood donor recruitment in Guangzhou, China, during the 2019 novel coronavirus (COVID-19) epidemic.","BACKGROUND
The coronavirus disease 2019 (COVID-19) epidemic affected blood collection in Guangzhou, China.
STUDY DESIGN AND METHODS
This paper includes three studies. The observational study reported the trends of blood collection during the epidemic in Guangzhou, China. The cross-sectional survey investigated factors influencing blood donation during the COVID-19 epidemic, and a self-administered questionnaire was given to 1584 street whole blood donors (SWBDs) who donated during the epidemic. The randomized controlled trial involved 19 491 SWBDs who donated in 2019 but did not donate during the epidemic. Trial participants were randomly assigned to two intervention groups: Group 1 completed Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; Group 2 completed Questionnaire 2, which did not include this information. A control group did not receive any questionnaire.
RESULTS
As measures were implemented, the number of blood donors increased accordingly. Both first-time and repeat SWBDs perceived the same level of blood need and donated blood because it would save lives. SWBDs who completed Questionnaire 1 expressed a greater intention to donate during the epidemic. Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within 3 weeks. Intention-to-treat analyses and average-treatment-effect-on-the-treated estimations confirmed that Questionnaire 1 could motivate SWBDs to actually donate blood.
CONCLUSION
Various measures could ease blood shortage during the COVID-19 epidemic. Administration of Questionnaire 1 could increase blood donations during the epidemic.",2020,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"['19,491 SWBDs who donated in 2019 but did not donate during the epidemic']","['Questionnaire 1, which contained precautionary measures in response to COVID-19 and other messages about blood donation during the epidemic; and group 2 completed Questionnaire 2, which did not include this information']","['blood donations', 'number of blood donors', 'blood shortage']","[{'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0375876', 'cui_str': 'Whole blood donor'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0005794', 'cui_str': 'Blood Donation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005795', 'cui_str': 'Blood donor'}, {'cui': 'C0005767', 'cui_str': 'Blood'}]",19491.0,0.0277604,Enabling blood donors to perceive a higher level of blood need and a lower level of COVID-19 infection risk related to blood donation mobilized experienced SWBDs to donate within three weeks.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Ou-Yang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Shi-Jie', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chun-Hua', 'Initials': 'CH', 'LastName': 'Bei', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'He', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jin-Yan', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hua-Qin', 'Initials': 'HQ', 'LastName': 'Liang', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yong-Shui', 'Initials': 'YS', 'LastName': 'Fu', 'Affiliation': 'Guangzhou Blood Center, Guangzhou, Guangdong, China.'}]",Transfusion,['10.1111/trf.15971']
1135,32633801,Effect of Probiotic Use on Antibiotic Administration Among Care Home Residents: A Randomized Clinical Trial.,"Importance
Probiotics are frequently used by residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care), although the evidence on whether probiotics prevent infections and reduce antibiotic use in these settings is limited.
Objective
To determine whether a daily oral probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 compared with placebo reduces antibiotic administration in care home residents.
Design, Setting, and Participants
Placebo-controlled randomized clinical trial of 310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018.
Interventions
Study participants were randomized to receive a daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 (total cell count per capsule, 1.3 × 1010 to 1.6 × 1010) (n = 155), or daily matched placebo (n = 155), for up to 1 year.
Main Outcomes and Measures
The primary outcome was cumulative antibiotic administration days for all-cause infections measured from randomization for up to 1 year.
Results
Among 310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial. Participant diary data (daily data including study product use, antibiotic administration, and signs of infection) were available for 98.7% randomized to the probiotic group and 97.4% randomized to placebo. Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50). A total of 120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group). Hospitalizations accounted for 94 of the events in probiotic group and 78 events in the placebo group, and deaths accounted for 33 of the events in the probiotic group and 32 of the events in the placebo group.
Conclusions and Relevance
Among care home residents in the United Kingdom, a daily dose of a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12 did not significantly reduce antibiotic administration for all-cause infections. These findings do not support the use of probiotics in this setting.
Trial Registration
ISRCTN Identifier:16392920.",2020,"Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50).","['120 care home residents experienced 283 adverse events (150 adverse events in the probiotic group and 133 in the placebo group', '310 randomized care home residents (mean age, 85.3 years; 66.8% women), 195 (62.9%) remained alive and completed the trial', 'care home residents', 'Care Home Residents', 'residents in care homes (residential homes or nursing homes that provide residents with 24-hour support for personal care or nursing care', '310 care home residents, aged 65 years and older, recruited from 23 care homes in the United Kingdom between December 2016 and May 2018, with last follow-up on October 31, 2018']","['Lactobacillus rhamnosus GG', 'Probiotic', 'Placebo', 'daily capsule containing a probiotic combination of Lactobacillus rhamnosus GG and Bifidobacterium animalis subsp lactis BB-12', 'placebo']","['Antibiotic Administration', 'Participant diary data (daily data including study product use, antibiotic administration, and signs of infection', 'deaths', 'cumulative antibiotic administration days for all-cause infections', 'Hospitalizations']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0338046', 'cui_str': 'Residential home'}, {'cui': 'C0038931', 'cui_str': 'Nursing, Perioperative'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.418672,"Care home residents randomized to the probiotic group had a mean of 12.9 cumulative systemic antibiotic administration days (95% CI, 0 to 18.05), and residents randomized to placebo had a mean of 12.0 days (95% CI, 0 to 16.95) (absolute difference, 0.9 days [95% CI, -3.25 to 5.05]; adjusted incidence rate ratio, 1.13 [95% CI, 0.79 to 1.63]; P = .50).","[{'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Eleri', 'Initials': 'E', 'LastName': 'Owen-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Specialist Antimicrobial Chemotherapy Unit, Public Health Wales Microbiology, University Hospital of Wales, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Antony J', 'Initials': 'AJ', 'LastName': 'Bayer', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shepherd', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'F D Richard', 'Initials': 'FDR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davoudianfar', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Rutter', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Radcliffe Primary Care Bldg, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, Cardiff University, Heath Park, Cardiff, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fuller', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Primary Care and Population Sciences Unit, University of Southampton, Aldermoor Health Centre, Aldermoor Close, Southampton, United Kingdom.'}]",JAMA,['10.1001/jama.2020.8556']
1136,32612574,Are the Effects of Oral and Vaginal Contraceptives on Bone Formation in Young Women Mediated via the Growth Hormone-IGF-I Axis?,"Purpose: Combined hormonal contraceptive therapy has been associated with negative bone mineral density outcomes that may be route-dependent [i.e., combined oral contraception (COC) vs. contraceptive vaginal ring (CVR)] and involve the hepatic growth hormone (GH)/insulin-like growth factor-I (IGF-I) axis. The objective of the pilot study was to assess the impact of route of contraceptive administration on IGF-I and procollagen type I N-terminal propeptide (PINP) responses to an IGF-I Generation Test. We hypothesized that the peak rise in IGF-I and PINP concentration and area under the curve (AUC) would be attenuated following COC, but not CVR, use. Methods: Healthy, premenopausal women not taking hormonal contraception were recruited. Women were enrolled in the control group ( n = 8) or randomly assigned to COC ( n = 8) or CVR ( n = 8) for two contraceptive cycles. IGF-I Generation Tests were used as a probe to stimulate IGF-I release and were completed during the pre-intervention and intervention phases. Serum IGF-I and PINP were measured during both IGF-I Generation Tests. The study was registered at ClinicalTrials.gov (NCT02367833). Results: Compared to the pre-intervention phase, peak IGF-I concentration in response to the IGF-I Generation Test in the intervention phase was suppressed in the COC group ( p < 0.001), but not the CVR or Control groups ( p > 0.090). Additionally, compared to the pre-intervention phase, PINP AUC during the intervention phase was suppressed in both COC and CVR groups ( p < 0.001), while no difference was observed in the control group ( p = 0.980). Conclusion: These data suggest that changes in recombinant human GH-stimulated hepatic IGF-I synthesis in response to combined hormonal contraception (CHC) use are dependent on route of CHC administration, while the influence on PINP is route-independent. Future research is needed to expand these results with larger randomized control trials in all age ranges of women who utilize hormonal contraception. Clinical Trial Registration: www.ClinicalTrials.gov registration NCT02367833.",2020,"Compared to the pre-intervention phase, peak IGF-I concentration in response to the IGF-I Generation Test in the intervention phase was suppressed in the COC group ( p < 0.001), but not the CVR or Control groups ( p > 0.090).","['Healthy, premenopausal women not taking hormonal contraception were recruited', 'Young Women', 'women who utilize hormonal contraception']","['CVR', 'COC', 'combined oral contraception (COC) vs. contraceptive vaginal ring (CVR', 'hormonal contraceptive therapy', 'combined hormonal contraception (CHC', 'Oral and Vaginal Contraceptives']","['PINP AUC', 'peak IGF-I concentration', 'Serum IGF-I and PINP', 'recombinant human GH-stimulated hepatic IGF', 'IGF-I and procollagen type', 'peak rise in IGF-I and PINP concentration and area under the curve (AUC']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",,0.0683776,"Compared to the pre-intervention phase, peak IGF-I concentration in response to the IGF-I Generation Test in the intervention phase was suppressed in the COC group ( p < 0.001), but not the CVR or Control groups ( p > 0.090).","[{'ForeName': 'Heather C M', 'Initials': 'HCM', 'LastName': 'Allaway', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Division of Pediatric Endocrinology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Southmayd', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Stone', 'Affiliation': 'Department of Nutritional Science, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Connie M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Department of Nutritional Science, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Dylan L', 'Initials': 'DL', 'LastName': 'Petkus', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'De Souza', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00334']
1137,32620359,Randomized Controlled Trial of the Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS) for Caregiving Journey: A National Family Caregiver Support Program in a Long-Term Care Insurance System.,"OBJECTIVES
To investigate the effects of a national support program on family caregivers for long-term care (LTC) recipients.
DESIGN
A single-blinded randomized controlled trial compared the 8-week Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS) program consisting of 6 individual in-home, 3 group support, and 2 telephone sessions with a multicomponent intervention, and a control group.
SETTING AND PARTICIPANTS
In total, 969 caregivers who were living with LTC recipients assessed as having a high caregiving burden in 12 Korean cities.
MEASURES
The primary outcomes were depression, burden, and stress levels of caregivers, the secondary outcomes were caregiver self-efficacy, positive aspects of caregiving, social support, social activities, and health risk behaviors. These outcomes were measured at baseline and after the 8-week program, analyzed using modified intention-to-treat, per-protocol (PP), and non-PP analyses.
RESULTS
The modified intention-to-treat analysis revealed significant improvements in burden (effect size, = 0.010, P = .008), depression (η p 2 = 0.012, P = .003), and health risk behaviors (η p 2 = 0.010, P = .012) for the experimental group compared with the control group. However, there were no significant differences between the 2 groups in improving stress (P = .997), social support (P = .234), or social activities (P = .816). The PP analysis indicated that the COMPASS program was successful in increasing positive aspects of caregiving (η p 2 = 0.013, P = .004) and self-efficacy (η p 2 = 0.010, P = .032) compared with the control group.
CONCLUSIONS AND IMPLICATIONS
The COMPASS program was effective in family caregivers of LTC recipients in critical aspects of physical and psychological outcomes, especially in demonstrating the important role of participating in group support sessions. It is feasible for the program to become a formal national support program as part of the national insurance system in Republic of Korea.",2020,"However, there were no significant differences between the 2 groups in improving stress (P = .997), social support (P = .234), or social activities (P = .816).","['969 caregivers who were living with LTC recipients assessed as having a high caregiving burden in 12 Korean cities', 'Caregiving Journey', 'family caregivers for long-term care (LTC) recipients']","['Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS', '8-week Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS) program consisting of 6 individual in-home, 3 group support, and 2 telephone sessions with a multicomponent intervention, and a control group', 'national support program', 'COMPASS program']","['depression, burden, and stress levels of caregivers, the secondary outcomes were caregiver self-efficacy, positive aspects of caregiving, social support, social activities, and health risk behaviors', 'improving stress', 'positive aspects of caregiving', 'health risk behaviors', 'self-efficacy', 'social activities', 'depression', 'social support']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015737', 'cui_str': 'National Government'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4505097', 'cui_str': 'Health Risk Behaviors'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",969.0,0.0558047,"However, there were no significant differences between the 2 groups in improving stress (P = .997), social support (P = .234), or social activities (P = .816).","[{'ForeName': 'Eun-Jeong', 'Initials': 'EJ', 'LastName': 'Han', 'Affiliation': 'Health Insurance Policy Research Institute, National Health Insurance Service, Wonju, Republic of Korea.'}, {'ForeName': 'Myonghwa', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Republic of Korea. Electronic address: mhpark@cnu.ac.kr.'}, {'ForeName': 'Seyoung', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Health Insurance Policy Research Institute, National Health Insurance Service, Wonju, Republic of Korea.'}, {'ForeName': 'Thi-Thanh-Tinh', 'Initials': 'TT', 'LastName': 'Giap', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Duhee', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Korean Ministry of Health and Welfare, Sejong, Republic of Korea.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.05.011']
1138,32627589,"Effectiveness of social media (Facebook), targeted mailing, and in-person solicitation for the recruitment of young adult in a diabetes self-management clinical trial.","BACKGROUND/AIMS
Research is needed to identify promising recruitment strategies to reach and engage diverse young adults in diabetes clinical research. The aim of this study was to examine the relative strengths and weaknesses of three recruitment strategies used in a diabetes self-management clinical trial: social media advertising (Facebook), targeted mailing, and in-person solicitation of clinic patients.
METHODS
Strategies were compared in terms of (1) cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures. We further explored the appeal (overall and among age and gender subgroups) of social media advertisement features.
RESULTS
In-person recruitment of clinic patients was overall the most cost-effective strategy. However, differences in demographic, clinical, and psychosocial characteristics of participants recruited via different strategies suggest that the combination of these approaches yielded a more diverse sample than would any one strategy alone. Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
CONCLUSIONS
Ultimately, the utility of a recruitment strategy is defined by its ability to effectively attract people representative of the target population who are willing to enroll in and complete the study. Leveraging a variety of recruitment strategies appears to produce a more representative sample of young adults, including those who are less engaged in diabetes care.",2020,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
","['to yield participants who would not otherwise be reached by alternative strategies, and (3) likelihood of participants recruited through each strategy to adhere to study procedures']","['social media (Facebook), targeted mailing, and in-person solicitation']","['cost-effectiveness (i.e. cost of recruitment/number of enrolled participants), (2) ability']","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",3.0,0.147519,"Once successfully enrolled, there was no difference in study completion and intervention adherence between individuals recruited by the three recruitment strategies.
","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, West Hollywood, CA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Carandang', 'Affiliation': 'University of California at San Diego, San Diego, CA, USA.'}, {'ForeName': 'Cheryl Lp', 'Initials': 'CL', 'LastName': 'Vigen', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Concha-Chavez', 'Affiliation': 'Northern Arizona University, Phoenix, AZ, USA.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Sequeira', 'Affiliation': 'Los Angeles Department of Health Services, Los Angeles, CA, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Diaz', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Raymond', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Pyatak', 'Affiliation': 'Chan Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520933362']
1139,32629091,Early-onset pneumonia following bag-mask ventilation versus endotracheal intubation during cardiopulmonary resuscitation: A substudy of the CAAM trial.,"AIM
Early-onset pneumonia (EOP) is a common in-hospital complication in survivors of out-of-hospital cardiac arrest. In this substudy of the CAAM trial, we aimed to compare whether bag mask ventilation (BMV) compared to endotracheal intubation (ETI) performed during cardiopulmonary resuscitation increases the risk of developing EOP.
METHODS
Adult patients from the CAAM trial that survived beyond 12 h of hospitalization were included. Information about in-hospital management and outcome of study subjects was systematically collected. Our primary aim was to compare the incidence of EOP in the BMV and ETI group using a series of bivariate analysis adjusting for one variable at a time and a logistic regression controlled for survival beyond 96 h, age, gender, catecholamine administration, no flow time, and initial shockable rhythm.
RESULTS
Of 627 patients from the CAAM trial that survived to hospital admission, 409 patients were hospitalized beyond 12 h and thus included (202 randomized to BMV and 20 7 randomized to ETI). Patients in the BMV group had a significantly longer period of unsecured airway during prehospital cardiopulmonary resuscitation (BMV (median): 33 min; ETI (median): 17 min, p < 0.0001). No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7-1.5], p = 1.0). We found no difference in the development of EOP according to airway management in the series of bivariate analyses or in the multivariable regression analysis either.
CONCLUSION
In this substudy of the CAAM trial, development of early-onset pneumonia in out-of-hospital cardiac arrest survivors did not depend on airway management technique during CPR.",2020,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","['cardiopulmonary resuscitation', 'Adult patients from the CAAM trial that survived beyond 12\u2009hours of hospitalization were included', '627 patients from the CAAM trial that survived to hospital admission', '409 patients were hospitalized beyond 12\u2009hours and thus included (202 randomized to BMV and 20 7 randomized to ETI']","['endotracheal intubation (ETI', 'bag-mask ventilation versus endotracheal intubation', 'bag mask ventilation (BMV']","['development of EOP according to airway management', 'risk of developing EOP', 'incidence of EOP']","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",627.0,0.0603892,"No significant difference in the development of EOP according to airway management was identified on univariate analysis (BMV: 53%, ETI: 53%, Odds Ratio 1.0 [0.7 - 1.5], p = 1.0).","[{'ForeName': 'Josefine S', 'Initials': 'JS', 'LastName': 'Baekgaard', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark; Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France. Electronic address: josefine.stokholm.baekgaard.01@regionh.dk.'}, {'ForeName': 'Mohamed N', 'Initials': 'MN', 'LastName': 'Triba', 'Affiliation': ""Sorbonne Paris Cité, Equipe Nanomédecine Biomarqueurs Détection, Laboratoire de Chimie, Structures et Propriétés de Biomateriaux et d'Agents Therapeutiques, UMR CNRS 7244, University Paris 13 Bobigny, France.""}, {'ForeName': 'Morgane', 'Initials': 'M', 'LastName': 'Brandeis', 'Affiliation': 'Service des Urgences, Hopital Ballanger, 93600 Aulnays, France.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Cohen', 'Affiliation': 'Intensive Care Unit, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gorlicki', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Lars S', 'Initials': 'LS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anesthesia, Centre of Head and Orthopaedics, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Deltour', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Lapostolle', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Adnet', 'Affiliation': 'Urgences et Samu 93, AP-HP, Hôpital Avicenne, Inserm U942, 93000 Bobigny, France.'}]",Resuscitation,['10.1016/j.resuscitation.2020.06.011']
1140,32631130,Augmenting Evidence-Based Care With a Texting Mobile Interventionist: A Pilot Randomized Controlled Trial.,"OBJECTIVE
This study aimed to evaluate the feasibility and clinical utility of training intensive psychiatric community care team members to serve as ""mobile interventionists"" who engage patients in recovery-oriented texting exchanges.
METHODS
A 3-month pilot randomized controlled trial was conducted to compare the mobile interventionist approach as an add-on to assertive community treatment (ACT) versus ACT alone. Participants were 49 individuals with serious mental illness (62% with schizophrenia/schizoaffective disorder, 24% with bipolar disorder, and 14% with depression). Clinical outcomes were evaluated at baseline, posttreatment, and 6-month follow-up, and satisfaction was evaluated posttreatment.
RESULTS
The intervention appeared feasible (95% of participants assigned to the mobile interventionist arm initiated the intervention, texting on 69% of possible days and averaging four messages per day), acceptable (91% reported satisfaction), and safe (no adverse events reported). Exploratory posttreatment clinical effect estimations suggested greater reductions in the severity of paranoid thoughts (Cohen's d=-0.61) and depression (d=-0.59) and improved illness management (d=0.31) and recovery (d=0.23) in the mobile interventionist group.
CONCLUSIONS
Augmentation of care with a texting mobile interventionist proved to be feasible, acceptable, safe, and clinically promising. The findings are encouraging given the relative ease of training practitioners to serve as mobile interventionists, the low burden placed on patients and practitioners, and the simplicity of the technology. The technical resources are widely accessible to patients and practitioners, boding well for potential intervention scalability. When pandemics such as COVID-19 block the possibility of in-person patient-provider contact, evidence-based texting interventions can serve a crucial role in supporting continuity of care.",2020,"CONCLUSIONS
Augmentation of care with a texting mobile interventionist proved to be feasible, acceptable, safe, and clinically promising.","['Participants were 49 individuals with serious mental illness (62% with schizophrenia/schizoaffective disorder, 24% with bipolar disorder, and 14% with depression']","['Texting Mobile Interventionist', 'assertive community treatment (ACT) versus ACT alone']","['6-month follow-up, and satisfaction', 'depression (d=-0.59) and improved illness management', 'severity of paranoid thoughts']","[{'cui': 'C0647859', 'cui_str': 'AM 49'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4517465', 'cui_str': '0.59'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}]",49.0,0.186904,"CONCLUSIONS
Augmentation of care with a texting mobile interventionist proved to be feasible, acceptable, safe, and clinically promising.","[{'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Ben-Zeev', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Meller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Hudenko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, BRiTE Center, University of Washington, Seattle (Ben-Zeev, Buck, Meller, Hallgren); Department of Psychological and Brain Sciences, Dartmouth College, and Department of Psychiatry, Dartmouth Geisel School of Medicine, Hanover, New Hampshire (Hudenko).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.202000239']
1141,32631142,Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: An overview.,"The stepped wedge cluster randomized design has received increasing attention in pragmatic clinical trials and implementation science research. The key feature of the design is the unidirectional crossover of clusters from the control to intervention conditions on a staggered schedule, which induces confounding of the intervention effect by time. The stepped wedge design first appeared in the Gambia hepatitis study in the 1980s. However, the statistical model used for the design and analysis was not formally introduced until 2007 in an article by Hussey and Hughes. Since then, a variety of mixed-effects model extensions have been proposed for the design and analysis of these trials. In this article, we explore these extensions under a unified perspective. We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity. We review the key model ingredients and clarify their implications for the design and analysis. The article serves as an entry point to the evolving statistical literatures on stepped wedge designs.",2020,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.",[],[],[],[],[],[],,0.0502379,"We provide a general model representation and regard various model extensions as alternative ways to characterize the secular trend, intervention effect, as well as sources of heterogeneity.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Taljaard', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Melnick', 'Affiliation': 'Department of Emergency Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}]",Statistical methods in medical research,['10.1177/0962280220932962']
1142,32640027,Serum VEGF Predicts Clinical Improvement Induced by Cerebrolysin Plus Donepezil in Patients With Advanced Alzheimer's Disease.,"Serum vascular endothelial growth factor (VEGF) increases with Alzheimer's disease (AD) severity and may prevent cognitive decline. However, information on the influence of AD drug therapy on circulating VEGF is limited. This study assessed changes in serum VEGF levels and its association with clinical and functional responses in mild to moderate AD patients who were treated with Cerebrolysin, donepezil, or the combined therapy in a randomized, controlled trial. Treatment with Cerebrolysin plus donepezil reduced elevated serum VEGF levels and improved functioning and cognition significantly compared with donepezil alone in patients with advanced AD, and treatment differences were more pronounced in patients with higher VEGF levels. Our results indicate that the combined therapy reversed the increase of serum VEGF in advanced AD, which was associated with cognitive and functional responses, particularly in patients with high baseline VEGF.",2020,"Treatment with Cerebrolysin plus donepezil reduced elevated serum VEGF levels, and improved functioning and cognition significantly compared to donepezil alone in patients with advanced AD; and treatment differences were more pronounced in patients with higher VEGF levels.","[""patients with advanced Alzheimer's disease"", 'mild to moderate AD patients who were treated with', 'patients with advanced AD']","['Cerebrolysin plus donepezil', 'donepezil', 'Cerebrolysin, donepezil, or the combined therapy']","['serum VEGF in advanced AD', 'elevated serum VEGF levels', 'cognitive and functional responses', 'serum VEGF levels', 'functioning and cognition', 'Serum vascular endothelial growth factor (VEGF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0055108', 'cui_str': 'cerebrolysin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0398602,"Treatment with Cerebrolysin plus donepezil reduced elevated serum VEGF levels, and improved functioning and cognition significantly compared to donepezil alone in patients with advanced AD; and treatment differences were more pronounced in patients with higher VEGF levels.","[{'ForeName': 'X Anton', 'Initials': 'XA', 'LastName': 'Alvarez', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Alvarez', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Antia', 'Initials': 'A', 'LastName': 'Martinez', 'Affiliation': 'Complexo Hospitalario Universitario de Ourense, Ourense, Spain.'}, {'ForeName': 'Iria', 'Initials': 'I', 'LastName': 'Romero', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Concha', 'Initials': 'C', 'LastName': 'Benito', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Suarez', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Mourente', 'Affiliation': 'Hospital Quirónsalud, A Coruña, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fantini', 'Affiliation': 'Hospital HM Modelo, A Coruña, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Figueroa', 'Affiliation': 'Medinova Institute of Neurosciences, Clinica RehaSalud, A Coruña, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Aleixandre', 'Affiliation': 'School of Psychology, Granada University, Granada, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Linares', 'Affiliation': 'Complejo Asistencial HHSCJ, Málaga, Spain.'}, {'ForeName': 'Dafin', 'Initials': 'D', 'LastName': 'Muresanu', 'Affiliation': 'Department of Clinical Neurosciences, University of Medicine and Pharmacy ""Iuliu Hațieganu,"" Cluj-Napoca, Romania.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'Ever NeuroPharma, Unterach, Austria.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Moessler', 'Affiliation': 'Comamo OG, Mondsee, Austria.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa046']
1143,32619739,Transvenous phrenic nerve stimulation for central sleep apnea is safe and effective in patients with concomitant cardiac devices.,"BACKGROUND
Central sleep apnea is common in heart failure patients. Transvenous phrenic nerve stimulation (TPNS) requires placing a lead to stimulate the phrenic nerve and activate the diaphragm. Data are lacking concerning the safety and efficacy of TPNS in patients with concomitant cardiovascular implantable electronic devices (CIEDs).
OBJECTIVE
To report the safety and efficacy of TPNS in patients with concomitant CIEDs.
METHODS
In the remedē System Pivotal Trial, 151 patients underwent TPNS device implant. This analysis compared patients with concomitant CIEDs to those without with respect to safety, implant metrics, and efficacy of TPNS. Safety was assessed using incidence of adverse events and device-device interactions. A detailed interaction protocol was followed. Implant metrics included overall TPNS implantation success. Efficacy endpoints included changes in the apnea-hypopnea index (AHI) and quality of life.
RESULTS
Of 151 patients, 64 (42%) had a concomitant CIED. There were no significant differences between the groups with respect to safety. There were 4 CIED oversensing events in 3 patients leading to 1 inappropriate defibrillator shock and delivery of antitachycardia pacing. There was no difference in efficacy between the CIED and non-CIED subgroups receiving TPNS, with both having similar percentages of patients who achieved ≥50% reduction in AHI and quality-of-life improvement.
CONCLUSION
Concomitant CIED and TPNS therapy is safe. The presence of a concomitant CIED did not seem to impact implant metrics, implantation success, and TPNS efficacy. A detailed interaction protocol should be followed to minimize the incidence of device-device interaction.",2020,There were no significant differences between the groups with respect to safety.,"['patients with concomitant CIEDs', 'heart failure patients', 'patients with concomitant cardiovascular implantable electronic devices (CIEDs', '151 patients underwent TPNS device implant', 'Of 151 patients, 64 (42%) had a concomitant CIED', 'Patients with Concomitant Cardiac Devices']","['Transvenous Phrenic Nerve Stimulation', 'Transvenous phrenic nerve stimulation (TPNS', 'Concomitant CIED and TPNS therapy', 'TPNS']","['apnea-hypopnea index (AHI) and quality of life', 'overall TPNS implantation success', 'efficacy', 'AHI and quality of life improvement', 'adverse events and device-device interactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0853893', 'cui_str': 'Device interaction'}]",151.0,0.0557761,There were no significant differences between the groups with respect to safety.,"[{'ForeName': 'Hemal M', 'Initials': 'HM', 'LastName': 'Nayak', 'Affiliation': 'Center for Arrhythmia Care, Heart and Vascular Center, The University of Chicago Pritzker School of Medicine, Chicago, Illinois. Electronic address: hnayak@uchicago.edu.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Center for Arrhythmia Care, Heart and Vascular Center, The University of Chicago Pritzker School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McKane', 'Affiliation': 'Respicardia, Inc, Minnetonka, Minnesota.'}, {'ForeName': 'Kristofer J', 'Initials': 'KJ', 'LastName': 'James', 'Affiliation': 'Respicardia, Inc, Minnetonka, Minnesota.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Meyer', 'Affiliation': 'Respicardia, Inc, Minnetonka, Minnesota.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Germany', 'Affiliation': 'Respicardia, Inc, Minnetonka, Minnesota.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stellbrink', 'Affiliation': 'Bielefeld Medical Center, Bielefeld, Germany.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Advocate Heart Institute, Naperville, Illinois.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Augostini', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, Ohio.'}]",Heart rhythm,['10.1016/j.hrthm.2020.06.023']
1144,32622904,"Effects of acute inspiratory loading during treadmill running on cerebral, locomotor and respiratory muscle oxygenation in women soccer players.","Respiratory limitation can be a primary mechanism for exercise cessation in female athletes. This study aimed to assess the effects of inspiratory loading (IL) on intercostal muscles (IM), vastus lateralis (VL) and cerebral (Cox) muscles oxygenation in women soccer players during high-intensity dynamic exercise. Ten female soccer players were randomized to perform in order two constant-load tests on a treadmill until the exhaustion time (Tlim) (100 % of maximal oxygen uptake- V˙O 2 ). They breathed freely or against a fixed inspiratory loading (IL) of 41 cm H 2 O (∼30 % of maximal inspiratory pressure). Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb]), total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI) were obtained by NIRs. Also, blood lactate [La - ] was obtained. IL significantly reduced Tlim (224 ± 54 vs 78 ± 20; P < 0.05) and increased [La - ], V˙O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05). IL also resulted in decrease of Δ[OxyHb] of Cox and IM during exercise compared with rest condition. In addition, decrease of Δ[OxyHb] was observed on IM during exercise when contrasted with Sham (P < 0.05). Furthermore, significant higher Δ[DeoxyHb] of IM and significant lower Δ[DeoxyHb] of Cox were observed when IL was applied during exercise in contrast with Sham (P < 0.05). These results were accompanied with significant reduction of Δ[tHb] and ΔTSI of IM and VL when IL was applied (P < 0.05). High-intensity exercise with IL decreased respiratory and peripheral muscle oxygenation with negative impact on exercise performance. However, the increase in ventilatory work did not impact cerebral oxygenation in soccer players.",2020,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","['women soccer players', 'Ten female soccer players', 'female athletes', 'women soccer players during high-intensity dynamic exercise', 'soccer players']","['acute inspiratory loading during treadmill running', 'Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb', 'High-intensity exercise with IL']","['Δ[OxyHb', 'intercostal (IM), vastus lateralis (VL) and cerebral (Cox) oxygenation', 'total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI', 'Δ[DeoxyHb', 'Δ[tHb] and ΔTSI of IM and VL', 'increased [La-], V̇O 2 , respiratory cycles and dyspnea', 'blood lactate [La', 'cerebral, locomotor and respiratory muscle oxygenation', 'exercise performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0592251,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","[{'ForeName': 'Flavia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Archiza', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Trimer', 'Affiliation': 'Physical Therapy Department, University of Santa Cruz Do Sul - UNISC, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Bonjorno-Junior', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Claudio Ricardo', 'Initials': 'CR', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Cleiton A', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103488']
1145,32633196,Swallowing Patterns in the HNC Population: Timing of Penetration-Aspiration Events and Residue.,"OBJECTIVE
This study described swallowing patterns in a large head/neck cancer (HNC) cohort.
STUDY DESIGN
In a retrospective review of data from a randomized controlled trial, we studied timing of penetration events as they related to aspiration and oral/pharyngeal residue.
SETTING
Retrospective review of a multicenter randomized controlled trial.
SUBJECTS AND METHODS
In total, 168 patients who were >3 months postradiation received baseline modified barium swallow evaluations. Retrospective analyses of data from these exams were studied, including Penetration-Aspiration Scale (PAS) scores and timing of these events (before, during, or after the swallow), as well as percentage of oral and pharyngeal residue.
RESULTS
Aspiration occurred more frequently after than before or during the swallow ( P < .05). There were significantly more events of penetration that led to aspiration after the swallow (n = 260) when compared to events before (n = 6) or after (n = 81) the swallow. There was more pharyngeal (16%-25%) than oral residue (5%-20%). Weak correlations were found between thin liquid, nectar-thick liquid, pudding residue, and PAS scores, with varying significance (pharyngeal residue/PAS r s : .26*, .35*, .07*; oral residue/PAS r s : .21*, .16, .3; * P < .05).
CONCLUSION
The predominant pattern for this sample of postradiation patients with HNC with dysphagia was aspiration that occurred after the swallow, rather than before or during the swallow. The aspiration was directly caused by penetration events that occurred during the swallow, resulting in aspiration as the airway reopened. Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events. These results guide clinicians in targeting appropriate swallowing interventions.",2020,"Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events.","['swallowing patterns in a large head/neck cancer (HNC) cohort', 'Swallowing Patterns in the HNC Population', '168 patients who were >3 months postradiation received baseline modified barium swallow evaluations']",['oral residue/PAS'],"['pharyngeal residue', 'percentage of oral and pharyngeal residue', 'Penetration-Aspiration Scale (PAS) scores and timing of these events']","[{'cui': 'C0426602', 'cui_str': 'Swallowing pattern'}, {'cui': 'C2243051', 'cui_str': 'Large head'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0203065', 'cui_str': 'Barium swallow'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",168.0,0.0169387,"Patients demonstrated more pharyngeal residue than oral residue, but a weak relationship was found between residue and penetration/aspiration events.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Pisegna', 'Affiliation': 'Boston University School of Medicine, Department of Otolaryngology, Boston, Massachusetts, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Langmore', 'Affiliation': 'Boston University School of Medicine, Department of Otolaryngology, Boston, Massachusetts, USA.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Meyer', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pauloski', 'Affiliation': 'University of Wisconsin-Milwaukee, College of Health Sciences, Comm-unication Sciences and Disorders, Milwaukee, Wisconsin, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599820933883']
1146,32634275,Evaluation of 2-Hour Post-Dose Efficacy of Lasmiditan for the Acute Treatment of Difficult-to-Treat Migraine Attacks.,"OBJECTIVE
To identify factors predicting response (2-hour headache pain freedom or most bothersome symptom freedom) to lasmiditan based on individual patient characteristics, migraine disease characteristics, and migraine attack characteristics. Further, efficacy specifically in difficult-to-treat patient/migraine disease characteristics or attack characteristics (ie, historically considered less responsive to certain acute therapies) subgroups was analyzed.
BACKGROUND
Knowledge of factors associated with a positive or negative response to acute treatment would be useful to practitioners prescribing acute treatments for migraine. Additionally, practitioners and patients would benefit from understanding the efficacy of lasmiditan specifically in subgroups of patients with migraine disease characteristics and migraine attack characteristics historically associated with decreased pain threshold, reduced efficacy of acute treatment, or increased burden of migraine.
METHODS
Pooled analyses were completed from 2 Phase 3 double-blind clinical trials, SPARTAN and SAMURAI. Data from baseline to 2 hours after taking lasmiditan (50, 100, or 200 mg) or placebo were analyzed to assess efficacy based on patient characteristics, migraine disease characteristics, and migraine attack characteristics. A total of 3981 patients comprising the intent-to-treat population were treated with placebo (N = 1130), lasmiditan 50 mg (N = 598), lasmiditan 100 mg (N = 1133), or lasmiditan 200 mg (N = 1120). Data were analyzed for the following efficacy measures at 2 hours: headache pain freedom and most bothersome symptom freedom.
RESULTS
None of the analyzed subgroups based on individual patient characteristics, migraine disease characteristics, or migraine attack characteristics predicted headache pain freedom or most bothersome symptom freedom response at 2 hours following lasmiditan treatment (interaction P ≥ .1). For the difficult-to-treat patient/migraine disease characteristics subgroups (defined as those with ≥24 headache days in the past 3 months, duration of migraine history ≥20 years, severe disability [Migraine Disability Assessment score ≥21], obesity [≥30 kg/m 2 ], and history of psychiatric disorder), single doses of lasmiditan (100 or 200 mg) were significantly more effective than placebo (P ≤ .002) in achieving both endpoints. Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan. For the difficult-to-treat migraine attack subgroups, patients with severe headache, co-existent nausea at the time of treatment, or who delayed treatment for ≥2 hours from the time of headache onset, both endpoint response rates after lasmiditan 100 or 200 mg were significantly greater than after placebo. Among those who delayed treatment for ≥4 hours from the time of headache onset, headache pain freedom response rates for the 200 mg dose of lasmiditan met statistical significance vs placebo (32.4% vs 15.9%; odds ratio = 2.7 [1.17, 6.07]; P = .018). While the predictors of response interaction test showed similar efficacy of lasmiditan vs placebo across subgroups defined by baseline functional disability (mild, moderate, or needs complete bed rest) at the time of treatment, analyses of lasmiditan efficacy within the subgroup ""needs complete bed rest"" appeared to show less efficacy (eg, in the 200 mg vs placebo group, 25.9% vs 18.5%; odds ratio = 1.56 [0.96, 2.53]; P = .070).
CONCLUSIONS
Efficacy of lasmiditan 200 and 100 mg for headache pain freedom and most bothersome symptom freedom at 2 hours post-treatment was generally not influenced by the individual patient characteristics, migraine disease history, or migraine attack characteristics that were analyzed. In the analyses of difficult-to-treat subgroups, patients receiving lasmiditan achieved greater responses (2-hour headache pain freedom and most bothersome symptom freedom) vs placebo recipients.",2020,Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan.,['3981 patients comprising the intent-to-treat population'],"['Lasmiditan', 'lasmiditan 50\xa0mg (N\xa0=\xa0598), lasmiditan 100\xa0mg (N\xa0=\xa01133), or lasmiditan 200\xa0mg', 'placebo']","['headache pain freedom or most bothersome symptom freedom response', 'time of headache onset, headache pain freedom response rates', 'Headache pain freedom response rates', 'headache pain freedom and most bothersome symptom freedom', 'headache pain freedom', 'duration of migraine history ≥20\xa0years, severe disability [Migraine Disability Assessment score ≥21], obesity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",3981.0,0.177233,Headache pain freedom response rates for higher doses of lasmiditan were numerically greater than for lower doses of lasmiditan.,"[{'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Vasudeva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krege', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Suchitrita S', 'Initials': 'SS', 'LastName': 'Rathmann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Doty', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bert B', 'Initials': 'BB', 'LastName': 'Vargas', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Magis', 'Affiliation': 'Department of Neurology and Headache and Pain Multimodal Management Clinic, CHR East Belgium Hospital, Verviers, Belgium.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Eli Lilly and Company, Kobe, Japan.'}]",Headache,['10.1111/head.13897']
1147,32648203,Letter to the Editor Regarding Efficacy and Safety of Diclofenac and Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study.,,2020,,"['Neck Pain', 'Patients with Acute Back']",['Diclofenac and Capsaicin Gel'],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0469216,,"[{'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Schwartz', 'Affiliation': 'Department of Anesthesiology, Mount Sinai Medical Center of Florida, Miami, FL, USA. rubenschwartz@yahoo.com.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Urits', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Viswanath', 'Affiliation': 'Valley Anesthesiology and Pain Consultants, Envision Physician Services, Phoenix, AZ, USA.'}]",Pain and therapy,['10.1007/s40122-020-00181-5']
1148,32648204,Author's Response to: 'Letter to the Editor Regarding Efficacy and Safety of Diclofenac and Capsaicin Gel in Patients with Acute Back/Neck Pain: A Multicenter Randomized Controlled Study'.,,2020,,"['Neck Pain', 'Patients with Acute Back']",['Diclofenac and Capsaicin Gel'],[],"[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0419255,,"[{'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Weiser', 'Affiliation': 'Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lange', 'Affiliation': 'Consumer Health Care, Medical Affairs, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany. robert1.lange@sanofi.com.'}]",Pain and therapy,['10.1007/s40122-020-00182-4']
1149,32624365,Could self-locking stand-alone cage reduce adjacent-level ossification development after aneterior cervical discectomy and fusion?,"Numerous studies have shown that cervical arthrodesis is associated with the adjacent-segment pathology (ASP), such as adjacent-level ossification development (ALOD). However, it still remains largely unclear whether the self-locking stand-alone implant system can reduce the incidence of ALOD. In the present study, we prospectively recruited 120 patients with cervical degenerative disc disease (CDDD) who were treated by anterior cervical discectomy and fusion (ACDF). These patients were randomly and evenly divided into the ROI-C group and plate group. Clinical and radiologic follow-up was performed at 3, 6, 12, 24 and 36 months after surgery. Clinical evaluation included preoperative and postoperative assessments of Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) score. The presence and severity of ALOD, as well as the C2-7 Cobb angle, were assessed on the lateral cervical films during follow-up. There were no significant differences in JOA and NDI scores at each time point during the follow-up period between the two groups. ALOD occurred in 8.8% of 58 patients and 6.7% of 104 levels in the cage group. Moreover, ALOD occurred in 20.1% of 57 patients and 17.8% of 101 levels in the plate group. The ALOD was more serious in the plate group compared with the cage group. The C2-7 Cobb angle was significantly improved compared with that before the operation and could be maintained during the follow-up in both groups. The self-locking stand-alone cage was efficacious for ACDF, and it could reduce the incidence of ALOD compared with anterior plate and cage.",2020,There were no significant differences in JOA and NDI scores at each time point during the follow-up period between the two groups.,['120 patients with cervical degenerative disc disease (CDDD) who were treated by anterior cervical discectomy and fusion (ACDF'],[],"['JOA and NDI scores', 'Japanese Orthopaedic Association (JOA) score and Neck Disability Index (NDI) score', 'ALOD']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]",[],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",120.0,0.0182449,There were no significant differences in JOA and NDI scores at each time point during the follow-up period between the two groups.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Xilei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China. Electronic address: dong.jian@zs-hospital.sh.cn.'}, {'ForeName': 'Xiaogang', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopaedic Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China. Electronic address: zhou.xiaogang@zs-hospital.sh.cn.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.06.014']
1150,32633020,Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes.,"OBJECTIVE
To compare transurethral resection in saline (TURIS), Greenlight laser vapo-enucleation of the prostate (GL.PVEP), and holmium laser enucleation of the prostate (HoLEP), for controlling lower urinary tract symptoms secondary to large benign prostatic hyperplasia (BPH) and to assess non-inferiority of 3-year re-treatment rates.
PATIENTS AND METHODS
Eligible patients with BPH (prostate size 80-150 mL) were randomly assigned to one of the intervention groups. Non-inferiority of re-treatment rate was evaluated using a one-sided test at 5% level of significance.
RESULTS
At the time of analysis, 60 GL.PVEP, 60 HoLEP and 62 TURIS procedures were included. Perioperative parameters were comparable between groups; however, the operative time was longer in GL.PVEP vs HoLEP and TURIS, at a mean (SD) of 92 (32) vs 73 (30) and 83 (28) min (P = 0.005); and was less effective with a mean (SD) removal of 1.2 (0.4) vs 1.7 (0.7) and 1.4 (0.6) g/min (P < 0.001), respectively. Perioperative complications and need for auxiliary procedures were similar in the three groups; however, there was a significantly higher rate of capsular perforation in TURIS group (five, 8%) compared to one (1.6%) in the GL.PVEP group and none in the HoLEP group (P = 0.01). There was a significantly longer hospital stay, catheter-time and higher rate of blood transfusion in the TURIS group. There was significant but comparable improvements in the International Prostate Symptom Score in three groups at different follow-up points. At 3 years, re-treatment for recurrent bladder outlet obstruction was required more after GL.PVEP and TURIS. More re-do surgeries for recurrent obstructing prostate adenoma was reported after GL.PVEP (four, 6.7%) and TURIS (six, 9.7%) than for HoLEP (none) (P = 0.04).
CONCLUSION
The perioperative outcomes of GL.PVEP and HoLEP surpassed that of TURIS for the treatment of large prostates, but with a significantly prolonged operative time with GL.PVEP. The three techniques achieve good functional outcomes; however, 3-year re-treatment rates following TURIS and GL.PVEP were inferior to HoLEP.",2020,"Perioperative complications and need for auxiliary procedures were similar in the three groups however significantly higher rate of capsular violation 5, 8% was reported in TURis group compared to 1, 1.6% in GL.PVEP and none in HoLEP, p=0.01.",['Eligible patients with BPH (80-150ml'],"['transurethral resection in saline (TURis) and Greenlight laser Vapo-Enucleation of the prostate (GL.PVEP', 'Holmium laser enucleation of the prostate (HoLEP', 'TURIS and GL.PVEP', 'bipolar resection vs. Holmium laser enucleation vs. Greenlight laser vapo-enucleation', 'TURIS']","['Perioperative complications and need for auxiliary procedures', 'operative efficiency', 'Perioperative parameters', 'longer operative time', 'recurrent obstructing prostate adenoma', 'rate of capsular violation', 'hospital-stay, catheter-time and higher rate of blood transfusion', 'operative time', 'IPSS', 'recurrent BOO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}]","[{'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0520477', 'cui_str': 'Benign adenoma of prostate'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1504431', 'cui_str': 'Idiopathic pneumonia syndrome'}]",,0.0360491,"Perioperative complications and need for auxiliary procedures were similar in the three groups however significantly higher rate of capsular violation 5, 8% was reported in TURis group compared to 1, 1.6% in GL.PVEP and none in HoLEP, p=0.01.","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Elshal', 'Affiliation': 'Mansoura Urology and Nephrology Center, Mansoura, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Soltan', 'Affiliation': 'Mansoura Urology and Nephrology Center, Mansoura, Egypt.'}, {'ForeName': 'Nasr A', 'Initials': 'NA', 'LastName': 'El-Tabey', 'Affiliation': 'Mansoura Urology and Nephrology Center, Mansoura, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': 'Mansoura Urology and Nephrology Center, Mansoura, Egypt.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Nabeeh', 'Affiliation': 'Mansoura Urology and Nephrology Center, Mansoura, Egypt.'}]",BJU international,['10.1111/bju.15161']
1151,32633040,The effect of a 2-mm inter-implant distance on esthetic outcomes in immediately non-occlusally loaded platform shifted implants in healed ridges: 12-month results of a randomized clinical trial.,"BACKGROUND
Three millimeter is considered as the minimum distance to obtain soft and bone tissue stability in case of adjacent implants. The possibility to preserve peri-implant bone level using a platform switching connection has questioned this concept.
PURPOSE
The study evaluates soft tissue maintenance and marginal bone stability around implants, placed at 2 or 3 mm of distance.
MATERIALS AND METHODS
Thirty patients received two immediately loaded implants either at 2-mm (test) or at 3-mm (control) of distance in the premolar area. Soft tissue esthetics (papilla height and fill, keratinized tissue, recession) and radiographic peri-implant bone level changes were measured at 3, 6, and 12 months.
RESULTS
No significant differences between the two groups were detected neither for all soft tissue esthetic outcomes nor for bone level modifications up to 12 months.
CONCLUSION
The results suggested that up to 12 months post-loading, both 2- and 3-mm inter-distance platform-switched implants in healed site, supported adequate esthetic outcomes and peri-implant bone stability.",2020,"No significant differences between the two groups were detected neither for all soft tissue esthetic outcomes nor for bone level modifications up to 12 months.
","['immediately non-occlusally loaded platform shifted implants in healed ridges', 'Thirty patients received two immediately loaded implants either at 2-mm (test) or at 3-mm (control) of distance in the premolar area']",['2-mm inter-implant distance'],"['bone level modifications', 'Soft tissue esthetics (papilla height and fill, keratinized tissue, recession) and radiographic peri-implant bone level changes', 'soft tissue esthetic outcomes', 'adequate esthetic outcomes and peri-implant bone stability', 'esthetic outcomes']","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",30.0,0.0544968,"No significant differences between the two groups were detected neither for all soft tissue esthetic outcomes nor for bone level modifications up to 12 months.
","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Rivara', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Guido Maria', 'Initials': 'GM', 'LastName': 'Macaluso', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Toffoli', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Calciolari', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Goldoni', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lumetti', 'Affiliation': 'Center of Dental Medicine, University of Parma, Parma, Italy.'}]",Clinical implant dentistry and related research,['10.1111/cid.12926']
1152,32639383,Comparison of Pupillometry With Surgical Pleth Index Monitoring on Perioperative Opioid Consumption and Nociception During Propofol-Remifentanil Anesthesia: A Prospective Randomized Controlled Trial.,"BACKGROUND
Intraoperative monitoring with pupillometry has shown promising results for nociception/antinociception balance monitoring. However, its benefits in clinical practice remain unproven. The aim of this study was to evaluate the efficacy of intraoperative pupillometry monitoring on intraoperative opioid consumption and postoperative pain compared to surgical pleth index (SPI), another widely investigated monitoring.
METHODS
American Society of Anesthesiologists (ASA) I-II patients scheduled for elective laparoscopic cholecystectomy were included. This prospective, parallel-arm, single-center study was conducted in 2 steps. First, we evaluated the feasibility of using pupillometry and SPI monitoring compared with conventional hemodynamic monitoring. Next, a parallel-arm, double-blind randomized study compared the peak postoperative pain measured with numerical rating scale (NRS) from 0 (no pain) to 10 (extreme pain) as a primary outcome between pupillometry (pupillometry group, n = 43) and SPI monitoring (SPI group, n = 43) using Mann-Whitney U test. Secondary outcomes included intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications.
RESULTS
In the preliminary study (n = 50), remifentanil consumption was less under pupillometry monitoring compared to SPI monitoring, and peak postoperative pain was lower under pupillometry compared to conventional monitoring. In the main study (n = 86), peak postoperative pain and intraoperative remifentanil consumption were lower in the pupillometry group (median [first to third quartile], 5 [4-6]; mean ± standard deviation [SD], 0.078 ± 0.019 μg·kg·minute) compared to the SPI group (7 [5-8] and 0.0130 ± 0.051 μg·kg·minute; P < .001), with the median difference in peak postoperative pain of -1 and its 95% confidence interval between -2 and -0.5. The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
CONCLUSIONS
Intraoperative pupillometry monitoring reduced intraoperative remifentanil consumption and postoperative pain. It may be an alternative option for intraoperative opioid control under general anesthesia in adult patients.",2020,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","['adult patients', 'American Society of Anesthesiologists (ASA']","['elective laparoscopic cholecystectomy', 'Pupillometry With Surgical Pleth Index Monitoring', 'intraoperative pupillometry monitoring', 'conventional hemodynamic monitoring', 'surgical pleth index (SPI', 'pupillometry and SPI monitoring', 'Propofol-Remifentanil Anesthesia']","['number of analgesic administrations', 'better responsiveness to fentanyl', 'Perioperative Opioid Consumption and Nociception', 'peak postoperative pain measured with numerical rating scale (NRS', 'intraoperative remifentanil consumption and postoperative pain', 'peak postoperative pain', 'intraoperative opioid consumption and postoperative pain', 'peak postoperative pain and intraoperative remifentanil consumption', 'intraoperative remifentanil consumption, postoperative opioid responsiveness (a decrease in NRS by ≥1 after fentanyl administrations), number of analgesic administrations, and opioid-related complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4082936', 'cui_str': 'Hemodynamic monitoring'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.251762,"The pupillometry group had better responsiveness to fentanyl (84.6% vs 61.0%; P = .005) and lower number of analgesic administrations (2 [1-2] vs 2 [1-3]; P = .048) compared to the SPI group.
","[{'ForeName': 'Jong Hae', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Jwa', 'Affiliation': 'Division of Hepatobiliary Surgery, Department of Surgery, Daegu Catholic University Medical Center, School of Medicine, Daegu Catholic University, Daegu, Republic of Korea.'}, {'ForeName': 'Youjin', 'Initials': 'Y', 'LastName': 'Choung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Yeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Soo Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hanyang University Medical Center, College of Medicine, Hanyang University, Seoul, Republic of Korea.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004958']
1153,32636279,Effects of Zero PEEP and < 1.0 FIO2 on SpO2 and PETCO2 During Open Endotracheal Suctioning.,"BACKGROUND
Hyperoxygenation and hyperinflation, preferably with a mechanical ventilator, is the most commonly used technique to prevent the adverse effects of open endotracheal suctioning on arterial oxygenation and pulmonary volume. However, limited data are available on the effects of oxygen concentrations < 100% and PEEP with zero end-expiratory pressure (0 PEEP) to improve oxygenation and to maintain adequate ventilation during open endotracheal suctioning. The aim of this study was to analyze the behavior of [Formula: see text] and end-tidal CO 2 pressure ([Formula: see text]) in open endotracheal suctioning using the 0 PEEP technique with baseline [Formula: see text] (0 PEEP baseline [Formula: see text]) and 0 PEEP + hyperoxygenation of 20% above the baseline value (0 PEEP [Formula: see text] + 0.20) in critically ill subjects receiving mechanical ventilation.
METHODS
This was a prospective, randomized, single-blind crossover study, for which 48 subjects with various clinical and surgical conditions were selected; of these, 38 subjects completed the study. The subjects were randomized for 2 interventions: 0 PEEP baseline [Formula: see text] and 0 PEEP [Formula: see text] + 0.20 during the open endotracheal suctioning procedure. Oxygenation was assessed via oxygen saturation as measured with pulse oximetry ([Formula: see text]), and changes in lung were monitored via [Formula: see text] using volumetric capnography.
RESULTS
In the intragroup analysis with 0 PEEP baseline [Formula: see text], there was no significant increase after open endotracheal suctioning in either [Formula: see text] ( P = .63) or [Formula: see text] ( P = .11). With 0 PEEP [Formula: see text] + 0.20, there was a significant increase in [Formula: see text] ( P < .001), with no significant changes in [Formula: see text] ( P = .55). In the intergroup comparisons, there was a significant increase compared to the basal values only with the 0 PEEP + 0.20 method at 1 min after hyperoxygenation ( P < .001), post-immediately ( P < .001), at 1 min after ( P < .001), and at 2 min after open endotracheal suctioning ( P < .001).
CONCLUSIONS
The appropriate indication of the hyperinflation strategy via mechanical ventilation using 0 PEEP with or without hyperoxygenation proved to be efficient to maintain [Formula: see text] and [Formula: see text] levels. These results suggest that the technique can minimize the loss of lung volume due to open endotracheal suctioning. (ClinicalTrials.gov registration NCT02440919).",2020,", there was a significant increase in S pO 2 ( P < .001), with no significant changes in P ETCO 2 ( P = .55).","['48 subjects with various clinical and surgical conditions were selected; of these, 38 subjects completed the study', 'open endotracheal suctioning using the 0 PEEP technique with baseline F IO 2 ']",['PEEP F IO 2 + 0.20'],"['PEEP baseline F IO 2', 'S pO 2', 'basal values', 'loss of lung volume', 'via oxygen saturation as measured with pulse oximetry (S pO 2 ), and changes in lung']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",48.0,0.0440365,", there was a significant increase in S pO 2 ( P < .001), with no significant changes in P ETCO 2 ( P = .55).","[{'ForeName': 'Jacqueline Rodrigues', 'Initials': 'JR', 'LastName': 'de Freitas Vianna', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil. jacrfvianna@uol.com.br.'}, {'ForeName': 'Valéria Amorim', 'Initials': 'VA', 'LastName': 'Pires Di Lorenzo', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Miléa Mara', 'Initials': 'MM', 'LastName': 'Lourenço da S Simões', 'Affiliation': 'Intensive Care Physiotherapy, Santa Casa de Misericórdia Hospital, Batatais, São Paulo, Brazil.'}, {'ForeName': 'Jorge Luís', 'Initials': 'JL', 'LastName': 'Guerra', 'Affiliation': 'Intensive Care Physiotherapy, Santa Casa de Misericórdia Hospital, Batatais, São Paulo, Brazil.'}, {'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Jamami', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, São Carlos, São Paulo, Brazil.'}]",Respiratory care,['10.4187/respcare.07435']
1154,32632523,Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity.,"BACKGROUND
Due to the SARS-CoV2 pandemic, medical face masks are widely recommended for a large number of individuals and long durations. The effect of wearing a surgical and a FFP2/N95 face mask on cardiopulmonary exercise capacity has not been systematically reported.
METHODS
This prospective cross-over study quantitated the effects of wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask (ffpm) in 12 healthy males (age 38.1 ± 6.2 years, BMI 24.5 ± 2.0 kg/m 2 ). The 36 tests were performed in randomized order. The cardiopulmonary and metabolic responses were monitored by ergo-spirometry and impedance cardiography. Ten domains of comfort/discomfort of wearing a mask were assessed by questionnaire.
RESULTS
The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± 1.6 l/s; p < 0.001). The maximum power was 269 ± 45, 263 ± 42 and 277 ± 46 W with sm, ffpm and nm, respectively; p = 0.002; the ventilation was significantly reduced with both face masks (131 ± 28 vs 114 ± 23 vs 99 ± 19 l/m; p < 0.001). Peak blood lactate response was reduced with mask. Cardiac output was similar with and without mask. Participants reported consistent and marked discomfort wearing the masks, especially ffpm.
CONCLUSION
Ventilation, cardiopulmonary exercise capacity and comfort are reduced by surgical masks and highly impaired by FFP2/N95 face masks in healthy individuals. These data are important for recommendations on wearing face masks at work or during physical exercise.",2020,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","['12 healthy males (age 38.1\u2009±\u20096.2\xa0years, BMI 24.5\u2009±\u20092.0\xa0kg/m 2 ', 'healthy individuals']","['wearing a surgical and a FFP2/N95 face mask', 'wearing no mask (nm), a surgical mask (sm) and a FFP2/N95 mask', 'surgical and FFP2/N95 face masks']","['Cardiac output', 'Peak blood lactate response', 'ventilation', 'pulmonary function parameters', 'cardiopulmonary exercise capacity', 'cardiopulmonary and metabolic responses']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0181758', 'cui_str': 'Surgical face mask'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",12.0,0.0184074,"The pulmonary function parameters were significantly lower with mask (forced expiratory volume: 5.6 ± 1.0 vs 5.3 ± 0.8 vs 6.1 ± 1.0 l/s with sm, ffpm and nm, respectively; p = 0.001; peak expiratory flow: 8.7 ± 1.4 vs 7.5 ± 1.1 vs 9.7 ± ","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Fikenzer', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany. sven.fikenzer@medizin.uni-leipzig.de.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Uhe', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lavall', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Rudolph', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Falz', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Busse', 'Affiliation': 'Institut für Sportmedizin und Prävention, Universität Leipzig, Marschner Str. 29, 04109, Leipzig, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hepp', 'Affiliation': 'Klinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Klinik und Poliklinik für Kardiologie, Universitätsklinikum Leipzig, Liebigstr. 20, 04103, Leipzig, Germany.'}]",Clinical research in cardiology : official journal of the German Cardiac Society,['10.1007/s00392-020-01704-y']
1155,32628781,The systemic inflammatory response following hand instrumentation versus ultrasonic instrumentation-A randomized controlled trial.,"OBJECTIVE
This study sought to investigate whether the immediate systemic inflammatory response following full-mouth debridement differs following use of hand compared with ultrasonic instruments.
METHODS
Thirty-nine periodontitis patients were randomized to treatment with full-mouth debridement using either hand or ultrasonic instrumentation completed within 24 hr. Serum and periodontal clinical parameters were collected at baseline, day 1, day 7 and day 90 post-treatment. Differences in systemic inflammatory markers were assessed using general linear models at each timepoint, corrected for age, gender, smoking status, body mass index and baseline levels of each marker.
RESULTS
Across all patients, serum C-reactive protein increased at day 1, with no differences between hand and ultrasonic groups (p(adjusted) = .22). There was no difference between groups in interleukin-6 (p(adjusted) = .29) or tumour necrosis factor α (p(adjusted) = .53) at day 1. Inflammatory markers returned to baseline levels by day 7. Treatment resulted in equal and marked improvements in clinical parameters in both groups; however, total treatment time was on average shorter for ultrasonic instruments (p(adjusted) = .002).
CONCLUSIONS
Ultrasonic instrumentation resulted in shorter treatment time with comparable clinical outcomes. Levels of serum C-reactive protein at day 1 were similar following debridement with hand or ultrasonic instruments.",2020,There was no difference between groups in interleukin-6 (p(adjusted)=0.29) or tumour necrosis factor α,['Thirty-nine periodontitis patients'],['full-mouth debridement using either hand or ultrasonic instrumentation'],"['Serum and periodontal clinical parameters', 'Inflammatory markers', 'interleukin-6 (p(adjusted)=0.29) or tumour necrosis factor α', 'total treatment time', 'clinical parameters', 'serum C-reactive protein', 'Levels of serum C-reactive protein', 'Systemic Inflammatory Response', 'systemic inflammatory markers']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}]",39.0,0.23062,There was no difference between groups in interleukin-6 (p(adjusted)=0.29) or tumour necrosis factor α,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Johnston', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Paterson', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Krystyna', 'Initials': 'K', 'LastName': 'Piela', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Davison', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Goulding', 'Affiliation': 'Global Clinical Affairs, Dentsply Sirona, York, PA, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Ramage', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Sherriff', 'Affiliation': 'Community Oral Health, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Shauna', 'Initials': 'S', 'LastName': 'Culshaw', 'Affiliation': 'Oral Sciences, Glasgow Dental Hospital and School, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}]",Journal of clinical periodontology,['10.1111/jcpe.13342']
1156,32638504,"Efficacy and Safety of Upadacitinib Monotherapy in Methotrexate-Naive Patients With Moderately-to-Severely Active Rheumatoid Arthritis (SELECT-EARLY): A Multicenter, Multi-Country, Randomized, Double-Blind, Active Comparator-Controlled Trial.","OBJECTIVE
The SELECT-EARLY trial was undertaken to study the effect of upadacitinib, an oral, reversible Janus kinase 1-selective inhibitor, as monotherapy in patients with predominantly early rheumatoid arthritis who were naive for or had limited exposure to methotrexate (MTX).
METHODS
Patients (n = 947) were randomized 1:1:1 to receive once-daily doses of upadacitinib 15 mg or 30 mg or weekly MTX (7.5-20 mg/week) for 24 weeks. The primary end points were the proportion of patients who met the American College of Rheumatology 50% (ACR50) improvement criteria at week 12, and the proportion in whom a Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP) of <2.6 was achieved at week 24. Data are presented through week 24.
RESULTS
At baseline, the median disease duration was 0.5 years (range 0-44 years). A total of 840 patients (89%) completed 24 weeks of treatment. The study met both primary end points for upadacitinib 15 mg and 30 mg versus MTX (ACR50 was achieved at week 12 in 52% and 56% of patients, respectively, versus 28% [P < 0.001], and DAS28-CRP <2.6 was achieved at week 24 in 48% and 50% of patients, respectively, versus 19% [P < 0.001]). Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes (PROs) were recorded for both upadacitinib doses versus MTX. Overall, 88% of patients receiving upadacitinib 15 mg and 89% of patients receiving 30 mg, respectively, had no radiographic progression (modified total Sharp score ≤0) compared to 78% of those receiving MTX (P < 0.01). Through week 24, the frequency of treatment-emergent adverse events was similar between the MTX arm (65%) and upadacitinib 15 mg arm (64%), but was slightly higher in the upadacitinib 30 mg arm (71%). Six deaths were reported (2 in the upadacitinib 15 mg arm, 3 in the upadacitinib 30 mg arm, and 1 in the MTX arm).
CONCLUSION
Our findings indicate that patients receiving either dose of upadacitinib monotherapy experienced significant improvements in clinical, radiographic, and PROs compared to patients receiving MTX.",2020,Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate.,"['Patients were randomized (n=947, 1:1:1) to', 'naïve Patients with Moderately to Severely Active Rheumatoid Arthritis (SELECT-EARLY', 'patients with predominantly early rheumatoid arthritis who are naïve or have limited exposure to methotrexate']","['upadacitinib 15mg and 30mg versus methotrexate ', 'Methotrexate', 'upadacitinib monotherapy', 'Upadacitinib Monotherapy', 'methotrexate', 'once-daily upadacitinib', 'upadacitinib, an oral, reversible, JAK inhibitor']","['Efficacy and Safety', 'median disease duration', 'frequency of treatment-emergent adverse events', 'proportions of patients achieving ≥50% response in the American College of Rheumatology (ACR) criteria at Week 12, and proportions achieving a 28-joint Disease Activity Score including C-reactive protein (DAS28[CRP', 'radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0597721', 'cui_str': 'JAK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.286938,Statistically significant and clinically meaningful improvements in multiple patient-reported outcomes were recorded with both upadacitinib doses versus methotrexate.,"[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Vollenhoven', 'Affiliation': 'Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Friedman', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'AbbVie, Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Rischmueller', 'Affiliation': 'The Queen Elizabeth Hospital and University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Hospital Universitario Marques de Valdecilla and IDIVAL, Santander, Spain.'}, {'ForeName': 'Ricardo M', 'Initials': 'RM', 'LastName': 'Xavier', 'Affiliation': 'Universidade Federal do Rio Grande do Sul Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Stanford University, Palo Alto, California, USA.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41384']
1157,32651338,"A double-blind, randomized, controlled study of two dose strengths of dalfampridine extended release on walking deficits in ischemic stroke.","BACKGROUND
Stroke-induced ischemia affects both cortex and underlying white matter. Dalfampridine extended release tablets (D-ER) enhance action potential conduction in demyelinated axons, which may positively affect post-stroke recovery.
OBJECTIVE
Based on promising preliminary data, we compared efficacy of D-ER administered at 7.5 mg or 10 mg with placebo on post-stroke ambulation. Primary study outcome (response) was a ≥20% increase on the 2-minute walk test (2 MinWT) at 12 weeks after first drug administration.
METHODS
This was a multicenter, randomized, placebo-controlled, 3-arm, parallel-group, safety and efficacy trial. After obtaining baseline measures of 2 MinWT, Walk-12, and Timed Up and Go, subjects entered a 2-week, single-blind placebo run-in period and were randomized 1:1:1 to receive 7.5 mg D-ER, 10 mg D-ER, or placebo, dosed twice-daily for 12 weeks. Follow-up evaluations occurred at weeks 14 and 16 when subjects were off study drug.
RESULTS
The study was terminated early with 377 of planned 540 patients enrolled, due to no treatment effect. At week 12, mean increase in distances walked in 2 minutes were similar among the 3 study groups (14.9±40.0 feet; 19.4±39.6 feet; and 20.4±38.3 feet for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively). The proportion of subjects who showed ≥20% improvement on 2 MinWT at week 12 was 13.5%, 14.0%, and 19.0%, for placebo, 7.5 mg D-ER, and 10 mg D-ER, respectively; these were nonsignificant changes from baseline for all groups.
CONCLUSIONS
D-ER at either a 7.5-mg or 10-mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment. (Clinical Trial # NCT02271217).",2020,"CONCLUSIONS
D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","['stroke survivors with gait impairment', '377 of planned 540 patients enrolled, due to no treatment effect', 'ischemic stroke']","['Dalfampridine extended release tablets (D-ER', '7.5\u200amg D-ER, 10\u200amg D-ER, or placebo', 'D-ER', 'dalfampridine', 'placebo']","['distances walked', '2-minute walk test (2\u200aMinWT', 'walking deficits']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C5192767', 'cui_str': '540'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0991507', 'cui_str': 'Prolonged-release oral tablet'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",540.0,0.674871,"CONCLUSIONS
D-ER at either a 7.5 mg or 10 mg dose did not significantly increase performance on the 2 MinWT in stroke survivors with gait impairment, although this study was terminated early before full enrollment.","[{'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Page', 'Affiliation': 'RehabLab™, Neurorecovery Unlimited, LLC, Columbus, OH, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Kasner', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Bockbrader', 'Affiliation': 'Ohio State University Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'JEM Research Institute, Atlantis, FL, USA.'}, {'ForeName': 'Seth P', 'Initials': 'SP', 'LastName': 'Finklestein', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'MingMing', 'Initials': 'M', 'LastName': 'Ning', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Waleed H', 'Initials': 'WH', 'LastName': 'El-Feky', 'Affiliation': 'Texas Neurology, Dallas, TX, USA.'}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Wilson', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Roberts', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Restorative neurology and neuroscience,['10.3233/RNN-201009']
1158,32632173,"Immediate effects of lower limb loading exercise during stepping with and without augmented loading feedback on mobility of ambulatory individuals with spinal cord injury: a single-blinded, randomized, cross-over trial.","STUDY DESIGN
Single-blinded, randomized, cross-over design.
OBJECTIVES
To compare the immediate effects of bodyweight shifting and lower limb loading (LLL) exercise during stepping with and without augmented loading feedback, followed by overground walking, on the mobility of ambulatory individuals with spinal cord injury (SCI).
SETTING
Academic laboratory center.
METHODS
Thirty participants with SCI were trained using a single intervention session consisting of repetitive bodyweight shifting and LLL exercises during stepping with or without external feedback (10 min/leg) followed by overground walking (10 min) with a 2-week washout period, in a random sequence. The timed up-and-go test (TUG) (primary outcome), 10-m walk test (10MWT), five times sit-to-stand test (FTSST), and maximal LLL were measured 1 day before and immediately after each training session.
RESULTS
Significant improvement was found following both training sessions, excepting the TUG and LLL of the less-affected leg, where improvement was found only after training using augmented feedback. Moreover, the improvement following the training with feedback was significantly greater than that after training without feedback. The mean (95% CI) between-group differences for the TUG = 1.9 [0.6-3.3]s, 10MWT = 0.1 [0.0-0.1]m/s, FTSST = 1.0 [1.5-4.8]s, LLL = 3.1 [1.5-4.8]-2.8 [0.8-4.9]%bodyweight, p < 0.05.
CONCLUSIONS
The training programs immediately enhanced the mobility of ambulatory individuals with chronic SCI (post-injury time >6 years), particularly the training with augmented loading feedback. The findings offer another effective rehabilitation strategy that can be applied in various clinical and home-based settings.",2020,"RESULTS
Significant improvement was found following both training sessions, excepting the TUG and LLL of the less-affected leg, where improvement was found only after training using augmented feedback.","['Thirty participants with SCI', 'ambulatory individuals with spinal cord injury', 'ambulatory individuals with spinal cord injury (SCI', 'Academic laboratory center']","['lower limb loading exercise during stepping with and without augmented loading feedback', 'repetitive bodyweight shifting and LLL exercises during stepping with or without external feedback (10\u2009min/leg) followed by overground walking', 'bodyweight shifting and lower limb loading (LLL) exercise during stepping with and without augmented loading feedback, followed by overground walking']","['TUG and LLL of the less-affected leg', '10-m walk test (10MWT), five times sit-to-stand test (FTSST), and maximal LLL', 'mobility of ambulatory individuals with chronic SCI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]",30.0,0.0310246,"RESULTS
Significant improvement was found following both training sessions, excepting the TUG and LLL of the less-affected leg, where improvement was found only after training using augmented feedback.","[{'ForeName': 'Teerawat', 'Initials': 'T', 'LastName': 'Nithiatthawanon', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Pipatana', 'Initials': 'P', 'LastName': 'Amatachaya', 'Affiliation': 'Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand. pipatana.am@rmuti.ac.th.'}, {'ForeName': 'Thiwabhorn', 'Initials': 'T', 'LastName': 'Thaweewannakij', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Nuttaset', 'Initials': 'N', 'LastName': 'Manimmanakorn', 'Affiliation': 'Improvement of Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thanat', 'Initials': 'T', 'LastName': 'Sooknuan', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen, Thailand. samata@kku.ac.th.'}]",Spinal cord,['10.1038/s41393-020-0498-3']
1159,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1160,32649063,Efficacy of home-use light-emitting diode device at 637 and 854-nm for facial rejuvenation: A split-face pilot study.,"BACKGROUND
The use of light-emitting diode (LED) in combination wavelength for facial rejuvenation has been previously reported. Nowadays, there has been a growing market for home-use cosmetic devices because of its low cost and convenience.
AIMS
To evaluate the efficacy and safety of home-use LED device on facial rejuvenation.
METHODS
This was a prospective split-face clinical trial with a total of 24 subjects, who presented with photo aging skin. All subjects were treated with the home-use LED device on the left side of their face, twice a week for 8 weeks. Primary outcomes measured in the study were the changes in the biophysical properties of the skin assessed with the following parameters: skin elasticity, skin hydration, texture, and wrinkles. Evaluations were done at baseline, 2-, 4-, 6-, and 8-week follow-up. Subjects' self-improvement scores and adverse reactions were also recorded.
RESULTS
All 24 subjects completed the study and attended all follow-up. Skin elasticity was significantly higher in the LED group compared to the control during the 6- and 8-week follow-up (P < .05). In the LED group, an image of the treated skin captured using Visioscan ® showed improvement of the skin texture at 8-week follow-up. Majority of the subjects in the LED group scored good improvement on all follow-ups (37.5%, 41.7%, 58.3%, and 62.5%) when compared to the baseline. No adverse reactions or pain were recorded in the study.
CONCLUSION
The home-use LED device, with a combination wavelength of 637 and 854 nm, is safe and can be used as an adjunctive treatment for self-administered facial rejuvenation.",2020,"In the LED group, an image of the treated skin captured using Visioscan® showed improvement of the skin texture at 8-week follow-up.","['24 subjects, who presented with photo aging skin', 'All 24 subjects completed the study and attended all follow-up']","['home-use LED device', 'Home-Use Light-Emitting Diode Device', 'light-emitting diode (LED']","[""Subjects' self-improvement scores and adverse reactions"", 'Skin elasticity', 'biophysical properties of the skin assessed with the following parameters: skin elasticity, skin hydration, texture and wrinkles', 'efficacy and safety', 'adverse reactions or pain', 'skin texture']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037271', 'cui_str': 'Skin aging'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}, {'cui': 'C0005553', 'cui_str': 'Biophysics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0423752', 'cui_str': 'Finding of skin texture'}]",24.0,0.0396583,"In the LED group, an image of the treated skin captured using Visioscan® showed improvement of the skin texture at 8-week follow-up.","[{'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13613']
1161,32658385,Randomized trial of lung hyperinflation therapy in children with congenital muscular dystrophy.,"OBJECTIVE
Respiratory compromise in congenital muscular dystrophy (CMD) occurs, in part, from chest wall contractures. Passive stretch with hyperinsufflation therapy could reduce related costo-vertebral joint contractures. We sought to examine the impact of hyperinsufflation use on lung function and quality of life in children with CMD.
STUDY DESIGN
We conducted a randomized controlled trial on hyperinsufflation therapy in children with CMD at two centers. An individualized hyperinsufflation regimen of 15 minutes twice daily using a cough assist device over a 12 months period was prescribed. We measured lung function, quality of life, and adherence. To demonstrate reproducibility, pulmonary function was measured twice on the same day. A mixed-effects regression model adjusting for confounders was used to assess the effects of hyperinsufflation.
RESULTS
We enrolled 34 participants in the study; 31 completed the trial (n = 17 treatment group and n = 14 controls). Participants in the treatment group demonstrated a relative gain in lung volume measured at 4 and 8 months, but not at 12 months. The control group required increases in the maximum insufflation pressures to achieve maximum lung volumes while the treatment group did not. Adherence was best early in the study, peaking at the first visit and decreasing at subsequent visits. Caregiver-reported quality of life was higher in the treatment group.
CONCLUSION
Hyperinsufflation therapy is effective in increasing and sustaining lung volume over time. Adherence, however, was inconsistent and difficult to maintain. Further research should determine if improved adherence leads to sustained benefits of hyperinsufflation.",2020,"Participants in the treatment group demonstrated a relative gain in lung volume measured at 4 and 8 months, but not at 12 months.","['34 participants in the study; 31 completed the trial (n=17 treatment group and n=14 controls', 'children with congenital muscular dystrophy', 'Children with Congenital Muscular Dystrophy', 'children with congenital muscular dystrophy at two centers']","['hyperinsufflation', 'Hyperinsufflation therapy', 'hyperinsufflation therapy', 'Lung Hyperinflation Therapy']","['lung function, quality of life and adherence', 'costo-vertebral joint contractures', 'relative gain in lung volume', 'reproducibility, pulmonary function', 'Caregiver-reported quality of life', 'lung function and quality of life', 'maximum insufflation pressures', 'Adherence']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0009918', 'cui_str': 'Contracture of joint'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",34.0,0.0666038,"Participants in the treatment group demonstrated a relative gain in lung volume measured at 4 and 8 months, but not at 12 months.","[{'ForeName': 'Hemant', 'Initials': 'H', 'LastName': 'Sawnani', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Oscar H', 'Initials': 'OH', 'LastName': 'Mayer', 'Affiliation': ""Division of Pulmonary Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Avani C', 'Initials': 'AC', 'LastName': 'Modi', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pascoe', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'McConnell', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'McDonough', 'Affiliation': ""Division of Pulmonary Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Rutkowski', 'Affiliation': 'Cure CMD Foundation and Kaiser SCPMG, Los Angeles, California.'}, {'ForeName': 'Md Monir', 'Initials': 'MM', 'LastName': 'Hossain', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Szczesniak', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Dawit G', 'Initials': 'DG', 'LastName': 'Tadesse', 'Affiliation': ""Division of Epidemiology and Biostatistics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Schuler', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Raouf', 'Initials': 'R', 'LastName': 'Amin', 'Affiliation': ""Division of Pulmonary Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}]",Pediatric pulmonology,['10.1002/ppul.24954']
1162,32643966,Strengthening the interpretability of clinical trial results by assessing the effect of informative censoring on the primary estimand in PRECISION.,"BACKGROUND
The ICH E9(R1) addendum states that the strategy to account for intercurrent events should be included when defining an estimand, the treatment effect to be estimated based on the study objective. The estimator used to assess the treatment effect needs to be aligned with the estimand that accounted for intercurrent events. Regardless of the strategy, missing data resulting from patient premature withdrawal could undermine the robustness of the study results. Informative censoring due to dropouts in an events-based study is one such example. Sensitivity analyses using imputation methods are useful to examine the uncertainty due to informative censoring and address the robustness and strength of the study results.
METHODS
We assessed the effect of premature patient withdrawal in the PRECISION study, a randomized non-inferiority clinical trial of patients with chronic arthritic pain that compared the cardiovascular safety of three nonsteroidal anti-inflammatory drugs-based treatment policies or paradigms. The protocol-defined use of concomitant or rescue medications was permitted since changes in pain medications due to insufficient analgesia were expected in patients in this long-term study. Anticipating that premature study discontinuations could potentially lead to informative censoring, a supplementary analysis was pre-specified in which censored outcomes due to the premature study discontinuation were imputed based on adverse events that were clinically associated with the primary endpoint (cardiovascular outcome based on the Antiplatelet Trialists Collaboration composite endpoint). Furthermore, tipping point analyses were conducted to test the robustness of the primary analysis results by assuming data censored not at random. The level of increase at which the primary study conclusion would change was estimated.
RESULTS
For the analysis of time to first primary endpoint event through 30 months, 4065 out of the 24,081 enrolled patients were lost to follow-up, withdrew consent, or were no longer willing to participate in the study. These withdrawals occurred gradually and resulted in a cumulative total of 5893 censored patient-years of observation (10.2%). The rate of discontinuation and the baseline characteristics of the discontinued patients were similar across the three treatment groups. The non-inferiority conclusion from the primary analysis was confirmed in the supplementary analysis incorporating relevant adverse events. Furthermore, tipping point analyses demonstrated that in order to lose non-inferiority in the primary analysis, the risk of primary endpoint events during the censored observation time would have to increase by more than 2.7-fold in the celecoxib group while remaining constant in the other nonsteroidal anti-inflammatory drugs groups, demonstrating that the scenarios where the study results are invalid appear not plausible.
CONCLUSIONS
Supplementary and sensitivity analyses presented to address informative censoring in PRECISION helped to further interpret and strengthen the study results.",2020,The rate of discontinuation and the baseline characteristics of the discontinued patients were similar across the three treatment groups.,['patients with chronic arthritic pain'],['celecoxib'],['rate of discontinuation'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C1444662', 'cui_str': 'Discontinued'}]",24081.0,0.0492784,The rate of discontinuation and the baseline characteristics of the discontinued patients were similar across the three treatment groups.,"[{'ForeName': 'Weihang', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gaffney', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Milton L', 'Initials': 'ML', 'LastName': 'Pressler', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Fayyad', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Wisemandle', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Beckerman', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Wolski', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Nissen', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520934747']
1163,32651595,Radiation-induced DNA double-strand breaks in peripheral leukocytes and therapeutic response of heel spur patients treated by orthovoltage X-rays or a linear accelerator.,"PURPOSE
Biodosimetric assessment and comparison of radiation-induced deoxyribonucleic acid (DNA) double-strand breaks (DSBs) by γH2AX immunostaining in peripheral leukocytes of patients with painful heel spur after radiation therapy (RT) with orthovoltage X‑rays or a 6-MV linear accelerator (linac). The treatment response for each RT technique was monitored as a secondary endpoint.
PATIENTS AND METHODS
22 patients were treated either with 140-kV orthovoltage X‑rays (n = 11) or a 6-MV linac (n = 11) with two weekly fractions of 0.5 Gy for 3 weeks. In both scenarios, the dose was prescribed to the International Commission on Radiation Units and Measurements (ICRU) dose reference point. Blood samples were obtained before and 30 min after the first RT session. γH2AX foci were quantified by immunofluorescence microscopy to assess the yield of DSBs at the basal level and after radiation exposure ex vivo or in vivo. The treatment response was assessed before and 3 months after RT using a five-level functional calcaneodynia score.
RESULTS
RT for painful heel spurs induced a very mild but significant increase of γH2AX foci in patients' leukocytes. No difference between the RT techniques was observed. High and comparable therapeutic responses were documented for both treatment modalities. This trial was terminated preliminarily after an interim analysis (22 patients randomized).
CONCLUSION
Low-dose RT for painful heel spurs with orthovoltage X‑rays or a 6-MV linac is an effective treatment option associated with a very low and comparable radiation burden to the patient, as confirmed by biodosimetric measurements.",2020,"RESULTS
RT for painful heel spurs induced a very mild but significant increase of γH2AX foci in patients' leukocytes.","['22\xa0patients were treated either with', 'patients with painful heel spur after radiation therapy (RT) with orthovoltage X‑rays or a\xa06-MV linear accelerator (linac']","['140-kV orthovoltage X‑rays (n\u202f=\u200911) or a\xa06-MV linac', 'Radiation-induced DNA double-strand breaks', 'radiation-induced deoxyribonucleic acid (DNA) double-strand breaks (DSBs) by γH2AX immunostaining']","['Blood samples', 'γH2AX foci']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0158322', 'cui_str': 'Calcaneal spur'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0023730', 'cui_str': 'Linear accelerator'}]","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0023730', 'cui_str': 'Linear accelerator'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0311474', 'cui_str': 'Deoxyribonucleic acid, double stranded'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0301647', 'cui_str': 'Strand breaks'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",,0.0289989,"RESULTS
RT for painful heel spurs induced a very mild but significant increase of γH2AX foci in patients' leukocytes.","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zahnreich', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany. zahnreic@uni-mainz.de.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Rösler', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Schwanbeck', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Karle', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidberger', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, University Medical Center, Mainz, Germany.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01662-4']
1164,32651634,Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest.,"PURPOSE
To compare endocrine responses to intermittent vs continuous enteral nutrition provision during short-term bed rest.
METHODS
Twenty healthy men underwent 7 days of bed rest, during which they were randomized to receive enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre) in a continuous (CONTINUOUS; n = 10; 24 h day -1 at a constant rate) or intermittent (INTERMITTENT; n = 10; as 4 meals per day separated by 5 h) pattern. Daily plasma samples were taken every morning to assess metabolite/hormone concentrations.
RESULTS
During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 pmol L -1 in CONTINUOUS, compared to 94 ± 38 pmol L -1 in INTERMITTENT (P = 0.001). Changes in glucose infusion rate were positively correlated with changes in fasting plasma GLP-1 concentrations (r = 0.44, P = 0.049).
CONCLUSION
Intermittent enteral nutrition attenuates the progressive rise in plasma leptin and insulinemia seen with continuous feeding during bed rest, suggesting that continuous feeding increases insulin requirements to maintain euglycemia. This raises the possibility that hepatic insulin sensitivity is impaired to a greater extent with continuous versus intermittent feeding during bed rest. To attenuate endocrine and metabolic changes with enteral feeding, an intermittent feeding strategy may, therefore, be preferable to continuous provision of nutrition. This trial was registered on clinicaltrials.gov as NCT02521025.",2020,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","['Twenty healthy men underwent 7\xa0days of bed rest, during which they were randomized to receive']","['enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre', 'continuous enteral nutrition']","['Changes in glucose infusion rate', 'insulin concentrations (interaction effect', 'insulin and leptin', 'fasting plasma GLP-1 concentrations', 'plasma leptin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",20.0,0.0678729,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","[{'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UK. J.T.Gonzalez@bath.ac.uk.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Holwerda', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Imre W K', 'Initials': 'IWK', 'LastName': 'Kouw', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}]",European journal of applied physiology,['10.1007/s00421-020-04431-4']
1165,32648662,Effect of losartan on the recoverability of renal function in anuric and oliguric patients with a solitary obstructed kidney: a double-blind randomized placebo-controlled trial.,"OBJECTIVES
To assess the role of the angiotensin receptor blocker losartan on the recoverability of renal function after de-obstruction in patients with anuria and oliguria.
MATERIALS AND METHODS
This was a double-blind randomized placebo-controlled trial in anuric or oliguric patients with calcular obstruction of solitary kidney. Patients with an anomalous kidney or those with an American Society of Anesthesiology score of >3 were excluded. After relief of obstruction, patients were allocated to receive either losartan potassium 25 mg or placebo for 3 months. Serum creatinine (sCr) and renographic glomerular filtration rate (GFR) were measured at nadir and after 3 months. Changes in sCr and renographic GFR were calculated by subtracting the values at nadir from those at 3 months. Improvement, stabilization or deterioration of sCr and renographic GFR were defined as percentage increase or decrease from nadir ≥10%, while changes <10% were considered as stabilization.
RESULTS
A total of 76 patients completed 3 months of follow-up. Demographics and peri-operative data were comparable in the two groups. The median (range) sCr change was -1.05 (-1.8, 0.4) and -0.5 (-1.3, 0.1) mg/dL in the losartan and placebo, groups, respectively (P = 0.07). In the losartan group, renographic GFR had improved in 26 (59.1%) and deteriorated in six (13.6%) patients, while, in the placebo group, it had improved in eight (25%) and deteriorated in 10 patients (31.3%; P = 0.01). Losartan also enhanced renographic GFR improvement vs placebo by a median (range) of 6.9 (-9, 44) vs 1.4 (-10, 32) mL/min (P = 0.004).
CONCLUSIONS
In patients with anuria and oliguria, losartan treatment contributes to renal function recoverability after relief of calcular obstruction of the solitary kidney.",2020,"Losartan had also enhanced Re GFR (median, range) change by 6.9 (-9, 44) versus 1.4 (-10, 32)","['76 patients had completed 3 months follow-up', 'Patients with anomalous kidney or those with ASA score of >3 were excluded', 'anuric and oliguric patients with solitary obstructed kidney', 'anuric and oliguric patients', 'oliguric patients with calculuar obstruction of solitary kidney']","['Angiotensin receptor blockade (ARB), losartan', 'Losartan', 'losartan potassium 25 mg or placebo', 'losartan', 'placebo']","['renal function', 'enhanced Re GFR', 'Serum creatinine (S.creat), renographic glomerular filtration rate (Re GFR', 'deterioration of Re GFR', 'Changes of S.creat and Re GFR', 'Improvement, stabilization or deterioration of S.creat and Re GFR']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0266294', 'cui_str': 'Renal agenesis, unilateral'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C2912327', 'cui_str': 'Losartan Potassium 25 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]",76.0,0.454264,"Losartan had also enhanced Re GFR (median, range) change by 6.9 (-9, 44) versus 1.4 (-10, 32)","[{'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Elkappany', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Abdelwahab', 'Initials': 'A', 'LastName': 'Hashem', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elkarta', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Sheashaa', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Osman', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Shokeir', 'Affiliation': 'Urology Department, Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",BJU international,['10.1111/bju.15168']
1166,32645213,Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies.,"OBJECTIVE
This post hoc analysis evaluated long-term efficacy and safety in patients with focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who entered open-label extension (OLEx) studies to receive long-term adjunctive perampanel.
METHODS
Patients aged 12 years and older who completed phase II or III randomized, double-blind, placebo-controlled studies could enter an OLEx study, each comprising a blinded conversion period followed by an open-label maintenance period (32-424 weeks; maximum perampanel dose = 12 mg/d). Exposure, seizure outcomes, and treatment-emergent adverse events (TEAEs) were analyzed.
RESULTS
Baseline characteristics were generally balanced between patients with FBTCS (n = 720) and GTCS (n = 138). Mean (standard deviation) cumulative duration of perampanel exposure was 102.3 (70.3) weeks (FBTCS) and 83.9 (38.4) weeks (GTCS). Retention rates were 50.0% for up to 4 years (FBTCS) and 49.2% for up to 2 years (GTCS). Across OLEx treatment durations, median reductions in seizure frequency per 28 days were 66.7% (FBTCS) and 80.6% (GTCS). Fifty percent and 75% responder and seizure-freedom rates were 59.5%, 45.3%, and 18.4%, respectively (FBTCS), and 72.5%, 51.5%, and 16.7%, respectively (GTCS). Efficacy was sustained for up to 4 years (FBTCS) and up to 3 years (GTCS), even when accounting for early dropouts. TEAE incidence was highest during Year 1 (FBTCS, 85.3%; GTCS, 86.2%); most common were dizziness and somnolence. During Year 1, serious TEAEs were reported in 81 (11.3%; FBTCS) and 10 (7.2%; GTCS) patients. TEAEs were consistent with the known safety profile of perampanel; no new safety signals were identified with long-term treatment.
SIGNIFICANCE
This post hoc analysis suggests long-term (up to 4 years) adjunctive perampanel (up to 12 mg/d) is efficacious and well tolerated in patients (aged 12 years and older) with FBTCS or GTCS.",2020,"Efficacy was sustained for up to 4 years (FBTCS) and up to 3 years (GTCS), even when accounting for early dropouts.","['patients (aged 12\xa0years and older) with FBTCS or GTCS', 'patients with focal to bilateral tonic-clonic seizures (FBTCS) or generalized tonic-clonic seizures (GTCS) who entered open-label extension (OLEx) studies', 'tonic-clonic seizures', 'Patients aged 12\xa0years and older who completed phase II or III randomized']","['GTCS', 'perampanel', 'FBTCS', 'adjunctive perampanel', 'placebo']","['efficacious and well tolerated', 'Retention rates', 'seizure frequency', 'Exposure, seizure outcomes, and treatment-emergent adverse events (TEAEs', 'seizure-freedom rates', 'Efficacy', 'Mean (standard deviation) cumulative duration of perampanel exposure', 'TEAE incidence', 'dizziness and somnolence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",720.0,0.190572,"Efficacy was sustained for up to 4 years (FBTCS) and up to 3 years (GTCS), even when accounting for early dropouts.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Rektor', 'Affiliation': 'Brno Epilepsy Center and Central European Institute of Technology (CEITEC), Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'National Epilepsy Center, Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'North Tohoku Epilepsy Center, Minato Hospital, Hachinohe, Japan.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Formerly: Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Hatfield, UK.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Laurenza', 'Affiliation': 'Formerly: Eisai Inc., Woodcliff Lake, New Jersey, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, Boise, Idaho, USA.'}]",Epilepsia,['10.1111/epi.16573']
1167,32651132,Effects of Exergaming on Cognitive and Social Functioning of People with Dementia: A Randomized Controlled Trial.,"OBJECTIVES
Physical activity in people with dementia (PwD) may enhance physical and mental functioning. Exergaming, which combines physical exercise with cognitive stimulation in a gaming environment, was developed to overcome barriers in performing physical activities. We evaluated the effects of exergaming in day care centers (DCCs) for PwD and informal caregivers (ICs).
DESIGN
A randomized controlled trial among 23 DCCs across the Netherlands randomized to exergaming (interactive cycling during 6 months) or a care-as-usual control group.
SETTING AND PARTICIPANTS
A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week.
METHODS
All outcomes were assessed using structured questionnaires during interviews with PwD and ICs at baseline (T0), 3 months (T1), and 6 months (T2). Primary outcomes: physical activity and mobility of the PwD.
SECONDARY OUTCOMES
physical, cognitive, emotional and social functioning, and quality of life for PwD. For ICs: experienced burden, quality of life, and positive care experiences.
RESULTS
Mixed-model analyses showed no statistically significant effects on primary outcomes. There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE): r = 2.30, 95% confidence interval (CI): 0.65, 3.96, P = .007; and Trail Making Test part A (TMT-A): r = -28.98, 95% CI: -54.89, -3.08, P = .029], social functioning (Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP): r = -1.86, 95% CI: -3.56, -0.17, P = .031), and positive post-test effects in ICs on distress caused by the PwD's neuropsychiatric symptoms (NPI-Q total distress: r = -3.30, 95% CI: -6.57, -0.03, P = .048) and on sense of competence (SSCQ: r = 2.78, 95% CI: 0.85, 4.71, P = .005).
CONCLUSIONS AND IMPLICATIONS
Exergaming appeared not effective on the primary outcomes. Despite the study being underpowered, we found positive effects on secondary outcomes for PwD and ICs, and no negative effects. We therefore recommend further study, dissemination, and implementation.",2020,There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE):,"['day care centers (DCCs) for PwD and informal caregivers (ICs', 'people with dementia (PwD', 'A total of 112 (73 exergaming, 39 control) community-dwelling dyads (PwD, IC), with the PwD visiting a DCC at least twice per week', 'People with Dementia', '23 DCCs across the Netherlands randomized to']","['physical exercise with cognitive stimulation', 'exergaming (interactive cycling during 6\xa0months) or a care-as-usual control group']","['Behavior Observation Scale for Intramural Psychogeriatrics subscale 1 (GIP', 'cognition [Mini-Mental State Examination (MMSE', 'Cognitive and Social Functioning', 'burden, quality of life, and positive care experiences', 'physical, cognitive, emotional and social functioning, and quality of life for PwD', 'social functioning', 'physical activity and mobility of the PwD']","[{'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1259909', 'cui_str': 'DCC protein, human'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0017467', 'cui_str': 'Psychiatry, Geriatric'}, {'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",,0.210403,There were statistically significant positive effects on PwD's secondary outcomes at T2 on cognition [Mini-Mental State Examination (MMSE):,"[{'ForeName': 'Joeke', 'Initials': 'J', 'LastName': 'van Santen', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, VUmc, Amsterdam, the Netherlands; Amsterdam Public Health Research Institute, Amsterdam, the Netherlands. Electronic address: j.vandermolen@amsterdamumc.nl.'}, {'ForeName': 'Rose-Marie', 'Initials': 'RM', 'LastName': 'Dröes', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, VUmc, Amsterdam, the Netherlands; Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Amsterdam Public Health Research Institute, Amsterdam, the Netherlands; Department of Epidemiology and Biostatistics, Amsterdam UMC, VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Olivier A', 'Initials': 'OA', 'LastName': 'Blanson Henkemans', 'Affiliation': 'Child Health, TNO, Leiden, the Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical- Neuro- and Developmental Psychology, Faculty of Behaviour and Movement Sciences, Vrije Universiteit Amsterdam, the Netherlands.'}, {'ForeName': 'Franka J M', 'Initials': 'FJM', 'LastName': 'Meiland', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, VUmc, Amsterdam, the Netherlands; Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.04.018']
1168,32649760,"Micronutrient supplementation of lactating Guatemalan women acutely increases infants' intake of riboflavin, thiamin, pyridoxal, and cobalamin, but not niacin, in a randomized crossover trial.","BACKGROUND
Maternal supplementation during lactation could increase milk B-vitamin concentrations, but little is known about the kinetics of milk vitamin responses.
OBJECTIVES
We compared acute effects of maternal lipid-based nutrient supplement (LNS) consumption (n = 22 nutrients, 175%-212% of the RDA intake for the nutrients examined), as a single dose or at spaced intervals during 8 h, on milk concentrations and infant intake from milk of B-vitamins.
METHODS
This randomized crossover trial in Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum who were randomly assigned to receive 3 treatments in a random order: bolus 30-g dose of LNS (Bolus); 3 × 10-g doses of LNS (Divided); and no LNS (Control), with control meals. Mothers attended three 8-h visits during which infant milk consumption was measured and milk samples were collected at every feed. Infant intake was assessed as $\mathop \sum \nolimits_{i\ = \ 1}^n ( {{\rm{milk\ volum}}{{\rm{e}}_{{\rm{feed\ }}n}} \times \ {\rm{nutrient\ concentratio}}{{\rm{n}}_{{\rm{feed}}\ n}}} )$ over 8 h.
RESULTS
Maternal supplementation with the Bolus or Divided dose increased least-squares mean (95% CI) milk and infant intakes of riboflavin [milk: Bolus: 154.4 (138.2, 172.5) μg · min-1 · mL-1; Control: 84.5 (75.8, 94.3) μg · min-1 · mL-1; infant: Bolus: 64.5 (56.1, 74.3) μg; Control: 34.5 (30.0, 39.6) μg], thiamin [milk: Bolus: 10.9 (10.1, 11.7) μg · min-1 · mL-1; Control: 7.7 (7.2, 8.3) μg · min-1 · mL-1; infant: Bolus: 5.1 (4.4, 6.0) μg; Control: 3.4 (2.9, 4.0) μg], and pyridoxal [milk: Bolus: 90.5 (82.8, 98.9) μg · min-1 · mL-1; Control: 60.8 (55.8, 66.3) μg · min-1 · mL-1; infant: Bolus: 39.4 (33.5, 46.4) μg; Control: 25.0 (21.4, 29.2) μg] (all P < 0.001). Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018) μg, P = 0.001] compared with Control. Niacin was unaffected.
CONCLUSIONS
Maternal supplementation with LNS as a Bolus or Divided dose was similarly effective at increasing milk riboflavin, thiamin, and pyridoxal and infant intakes, whereas only the Bolus dose increased cobalamin. Niacin was unaffected in 8 h. This trial was registered at clinicaltrials.gov as NCT02464111.",2020,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","['lactating Guatemalan women acutely increases infants', 'Quetzaltenango, Guatemala included 26 mother-infant dyads 4-6 mo postpartum']","['Niacin', 'LNS (Divided); and no LNS (Control), with control meals', 'maternal lipid-based nutrient supplement (LNS) consumption', 'LNS (Bolus); 3\xa0×', 'Micronutrient supplementation']","[' intake of riboflavin, thiamin, pyridoxal, and cobalamin', 'Infant intake', 'milk B-vitamin concentrations', ' 1}^n ( {{\\rm{milk\\ volum}}{{\\rm{e}}_{{\\rm{feed\\ }}n}} \\times \\ {\\rm{nutrient\\ concentratio}}{{\\rm{n}}_{{\\rm{feed}}\\ n}}} ', 'milk riboflavin, thiamin, and pyridoxal and infant intakes', 'least-squares mean']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023374', 'cui_str': 'Lesch-Nyhan syndrome'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0034263', 'cui_str': 'Pyridoxal'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.372535,"Only the Bolus dose increased cobalamin in milk [Bolus: 0.054 (0.047, 0.061) μg · min-1 · mL-1; Control: 0.041 (0.035, 0.048) μg · min-1 · mL-1, P = 0.039] and infant cobalamin intake [Bolus: 0.023 (0.020, 0.027) μg; Control: 0.015 (0.013, 0.018)","[{'ForeName': 'Juliana A', 'Initials': 'JA', 'LastName': 'Donohue', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Solomons', 'Affiliation': 'Center for Studies of Sensory Impairment, Aging and Metabolism, Guatemala City, Guatemala.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hampel', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Shahab-Ferdows', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}, {'ForeName': 'Mónica N', 'Initials': 'MN', 'LastName': 'Orozco', 'Affiliation': 'Center for Atitlán Studies, Universidad del Valle de Guatemala, Sololá, Guatemala.'}, {'ForeName': 'Lindsay H', 'Initials': 'LH', 'LastName': 'Allen', 'Affiliation': 'Western Human Nutrition Research Center, Agricultural Research Service, USDA, Davis, CA, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa147']
1169,32652684,"Prospective randomized trial of endoscopic vs open radial artery harvest for CABG: Clinical outcome, patient satisfaction, and midterm RA graft patency.","BACKGROUND AND AIM
Endoscopic radial artery (RA) harvest (ERAH) is an alternative to open RA harvest (ORAH) technique. Our aim was to ascertain clinical outcomes, patent satisfaction, and 1-year angiographic patency rates after ERAH and ORAH.
PATIENTS AND METHODS
A total of 50 patients undergoing coronary artery bypass grafting were prospectively randomized to two groups. In the ERAH group (25 patients) the RA was harvested endoscopically and in the ORAH group (25 patients) openly.
RESULTS
There were not differences between the groups in preoperative characteristics. Length of skin incision was shorter in ERAH (P < .001) but there were not differences in the length of RA, harvest time, blood flow, and pulsatility index after ERAH and ORAH. Wound healing was uniformly smooth in ERAH and there were two hematomas and one infection in ORAH. Postoperatively, major neuralgias were present in five patients in ORAH and none in ERAH and minor neuralgias in 11 and 3 patients (P = .02) respectively. Twenty-four patients in ERAH and four in ORAH graded their experience as excellent (P < .001). One-year angiographic RA patency was 90% without intergroup difference. Target vessel stenosis less than 90% adversely affected RA patency (P < .0001).
CONCLUSIONS
In expert center, ERAH does not appear to have negative impact on the time harvest, the length, and quality of RA conduit, the wound healing, and the occurrence of hand and forearm complications. In addition, provides excellent cosmetic result and patient satisfaction. RA graft patency is gratifying when placed to a target coronary artery vessel with stenosis greater than 90%.",2020,Twenty-four patients in ERAH and four in ORAH graded their experience as excellent (P < .001).,['50 patients undergoing coronary artery bypass grafting'],"['Endoscopic radial artery (RA) harvest (ERAH', 'ERAH', 'endoscopic vs open radial artery harvest for CABG']","['Wound healing', 'RA graft patency', 'length of RA, harvest time, blood flow, and pulsatility index after ERAH and ORAH', 'ERAH and minor neuralgias', 'Length of skin incision', 'time harvest, the length, and quality of RA conduit, the wound healing, and the occurrence of hand and forearm complications', 'patent satisfaction, and 1-year angiographic patency rates', 'angiographic RA patency', 'RA patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0441247', 'cui_str': 'Conduit'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}]",50.0,0.0571187,Twenty-four patients in ERAH and four in ORAH graded their experience as excellent (P < .001).,"[{'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Tamim', 'Affiliation': 'Department of Cardiac Surgery, King Fahd Military Medical Complex, Dhahran, KSA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Alexiou', 'Affiliation': 'Department of Cardiac Surgery, King Fahd Military Medical Complex, Dhahran, KSA.'}, {'ForeName': 'Donya', 'Initials': 'D', 'LastName': 'Al-Hassan', 'Affiliation': 'Department of Radiology, King Fahd Military Medical Complex, Dhahran, KSA.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Al-Faraidy', 'Affiliation': 'Department of Cardiology, King Fahd Military Medical Complex, Dhahran, KSA.'}]",Journal of cardiac surgery,['10.1111/jocs.14706']
1170,32659856,Bayesian and heterogeneity of treatment effect analyses of the HOT-ICU trial-A secondary analysis protocol.,"BACKGROUND
The Handling Oxygenation Targets in the Intensive Care Unit (HOT-ICU) trial is an ongoing randomised clinical trial exploring the benefits and harms of targeting a lower (8 kPa) versus a higher (12 kPa) arterial oxygenation target in adult patients acutely admitted to the intensive care unit (ICU) with hypoxaemic respiratory failure.
METHODS
This protocol describes a secondary analysis of the primary trial outcome, 90-day all-cause mortality. We will analyse the primary outcome using Bayesian methods, which allows quantification of probabilities of all effect sizes. We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: (a) severity of illness (Sequential Organ Failure Assessment (SOFA) score), (b) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (PaO 2 )/fraction of inspired oxygen (FiO 2 ) ratio), (c) vasopressor requirement (highest noradrenaline dose in the 24 hours prior to randomisation), and (d) plasma lactate concentration (latest prior to randomisation). Additionally, we will perform separate assessments of the treatment effect interaction with each of the baseline parameters above on the continuous scale and present these using conditional effects plots.
CONCLUSIONS
This secondary analysis will aid the interpretation of the HOT-ICU trial by evaluating probabilities of all effect sizes. In addition, we will evaluate whether HTE is present, thus, further evaluating benefits and harms of a lower versus a higher oxygenation target in adult ICU patients with acute hypoxaemic respiratory failure.",2020,"We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: 1) severity of illness (Sequential Organ Failure Assessment (SOFA) score), 2) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (","['adult ICU patients with acute hypoxaemic respiratory failure', 'adult patients acutely admitted to the intensive care unit (ICU) with hypoxaemic respiratory failure']",[],"['plasma lactate concentration', 'PaO 2 )/fraction of inspired oxygen (FiO 2 ) ratio', 'severity of illness (Sequential Organ Failure Assessment (SOFA) score), 2) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen ']","[{'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",,0.288622,"We will explore the presence of heterogeneity of treatment effects (HTE) using Bayesian hierarchical models in subgroups based on baseline parameters: 1) severity of illness (Sequential Organ Failure Assessment (SOFA) score), 2) severity of hypoxaemic respiratory failure (partial pressure of arterial oxygen (","[{'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Klitgaard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Olav L', 'Initials': 'OL', 'LastName': 'Schjørring', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Bodil S', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care 4131, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13669']
1171,32662191,Prolonged Exposure and Sertraline Treatments for Posttraumatic Stress Disorder Also Improve Multiple Indicators of Social Functioning.,"Trauma survivors with posttraumatic stress disorder (PTSD) frequently also suffer from difficulties in social functioning that range across emotional, cognitive, and environmental domains. A detailed evaluation of the differential impacts of effective PTSD treatments on social functioning is needed. Men and women (N = 200) with chronic PTSD received 10 weeks of prolonged exposure (PE) or sertraline in a randomized clinical trial and were followed for 24 months. A secondary data analysis examined changes in social functioning with regard to fear of intimacy; receipt of social support; and distress, avoidance, and negative cognitions in social situations. Effects were examined between treatments over time, controlling for baseline functioning. There were large, durable improvements across all indices. Compared to sertraline, PE was more efficient at reducing fear of intimacy and distress from negative social cognitions by posttreatment, ds = 0.94-1.14. Patients who received sertraline continued to improve over the course of follow-up, ds = 0.54-1.17. The differential speed of therapeutic effects may argue for more direct mechanisms in cognitive behavioral interventions versus cascade effects in serotonin reuptake inhibitors. Notably, both treatments produced substantial social benefits for trauma survivors with social functioning difficulties, and effect sizes were comparable to typical reductions in PTSD, depression, and anxiety.",2020,"Compared to sertraline, PE was more efficient at reducing fear of intimacy and distress from negative social cognitions by posttreatment, ds = 0.94-1.14.","['Posttraumatic Stress Disorder', 'Men and women (N = 200) with chronic PTSD received 10 weeks of', 'Trauma survivors with posttraumatic stress disorder (PTSD']","['sertraline', 'prolonged exposure (PE) or sertraline', 'Prolonged Exposure and Sertraline', 'sertraline, PE']","['distress, avoidance, and negative cognitions in social situations', 'substantial social benefits', 'fear of intimacy and distress from negative social cognitions', 'PTSD, depression, and anxiety']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",200.0,0.0201058,"Compared to sertraline, PE was more efficient at reducing fear of intimacy and distress from negative social cognitions by posttreatment, ds = 0.94-1.14.","[{'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Graham', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Natalia M', 'Initials': 'NM', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Hannah E', 'Initials': 'HE', 'LastName': 'Bergman', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Norah C', 'Initials': 'NC', 'LastName': 'Feeny', 'Affiliation': 'Department of Psychological Sciences, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Lori A', 'Initials': 'LA', 'LastName': 'Zoellner', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington, USA.'}]",Journal of traumatic stress,['10.1002/jts.22570']
1172,32662220,Clinical and radiographic comparative study to evaluate the efficacy of restoring destroyed primary incisors using two different techniques-A pilot study.,"OBJECTIVE
The restoration of destroyed maxillary primary incisors is difficult because of the insufficient amount of coronal structure. This pilot study aimed to compare the efficacy of composite posts technique and glass fiber posts technique in restoring destroyed primary incisors.
MATERIALS AND METHODS
Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries were randomly assigned after endodontic treatment into two groups: glass fiber posts (n = 18) and composite resin posts (n = 18). Blinded clinical evaluation was made at 3, 6, 9, and 12 months and Blinded radiographic evaluation was made at 6 and 12 months. The evaluation was according to the FDI criteria. Data were analyzed with Fisher's exact test (α = .05).
RESULT
After 12 months post-treatment, the success rates were 88.2% in glass fiber posts group and 70.6% in composite resin posts group. There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
CONCLUSION
Glass fiber posts technique and Composite posts technique may be used in the restoration of destroyed primary incisors.",2020,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
",['Thirty-six destroyed maxillary primary incisors in 11 children with early childhood caries'],"['composite resin posts', 'composite posts technique and glass fiber posts technique', 'glass fiber posts']",['success rates'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3714731', 'cui_str': 'Early childhood caries'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0080038', 'cui_str': 'Post Technic'}, {'cui': 'C0060317', 'cui_str': 'Fiberglass'}]",[],11.0,0.0235983,"There was no statistically significant difference between the two groups according to the evaluation criteria (p-value >.05).
","[{'ForeName': 'Seba', 'Initials': 'S', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}, {'ForeName': 'Abdul Wahab', 'Initials': 'AW', 'LastName': 'Nourallah', 'Affiliation': 'Department of Paediatric Dentistry, Faculty of Dentistry, Tishreen University, Syria.'}]",Clinical and experimental dental research,['10.1002/cre2.307']
1173,32646823,Lack of Effect of a Multicomponent Palliative Care Program for Nursing Home Residents on Hospital Use in the Last Month of Life and on Place of Death: A Secondary Analysis of a Multicountry Cluster Randomized Control Trial.,"OBJECTIVES
PACE Steps to Success is a 1-year train-the-trainer program aiming to integrate nonspecialist palliative care into nursing homes via staff education and organizational support. In this study, we aimed to explore whether this program resulted in changes in residents' hospital use and place of death.
DESIGN
Secondary analysis of the PACE cluster randomized controlled trial (ISRCTN14741671). Data were collected on deaths over the previous 4 months via questionnaires at baseline and postintervention.
SETTING AND PARTICIPANTS
Questionnaires were completed by the nurse/care-assistant most involved from 78 nursing homes in 7 European Union countries.
MEASURES
We measured number of emergency department visits, hospital admissions, length of hospital stay, and place of death. Baseline and postintervention scores between intervention and control groups were compared, and we conducted exploratory mixed-model analyses. We collected 551 out of 610 questionnaires at baseline and 984 out of 1178 at postintervention in 37 intervention and 36 control homes.
RESULTS
We found no statistical significant effects of the program on emergency department visits [odds ratio (OR) = 1.38, P = .32], hospital admissions (OR = 0.98, P = .93), length of hospital stay (geometric mean difference = 0.85, P = .44), or place of death (OR = 1.08, P = .80).
CONCLUSIONS AND IMPLICATIONS
We found no effect of the PACE program on either hospital use in the last month of life or place of death. Although this may be related to implementation problems in some homes, the program might also require a more specific focus on managing acute end-of-life situations and a closer involvement of general practitioners or specialist palliative care services to influence hospital use or place of death.",2020,".93), length of hospital stay (geometric mean difference = 0.85, P = .44), or place of death (","['Nursing Home Residents on Hospital Use in the Last Month of Life and on Place of Death', 'We collected 551 out of 610 questionnaires at baseline and 984 out of 1178 at postintervention in 37 intervention and 36 control homes', '78 nursing homes in 7 European Union countries']","['Multicomponent Palliative Care Program', 'PACE program']","[""residents' hospital use and place of death"", 'length of hospital stay', 'emergency department visits [odds ratio (OR)\xa0', 'number of emergency department visits, hospital admissions, length of hospital stay, and place of death', 'place of death ', 'hospital admissions']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0421611', 'cui_str': 'Place of death'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0421611', 'cui_str': 'Place of death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.0528792,".93), length of hospital stay (geometric mean difference = 0.85, P = .44), or place of death (","[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Honinx', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium. Electronic address: elisabeth.honinx@vub.be.'}, {'ForeName': 'Tinne', 'Initials': 'T', 'LastName': 'Smets', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Piers', 'Affiliation': 'Department of Geriatric Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'H Roeline W', 'Initials': 'HRW', 'LastName': 'Pasman', 'Affiliation': 'EMGO Institute for Health and Care Research, Department of Public and Occupational Health, Expertise Center for Palliative Care, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Sheila A', 'Initials': 'SA', 'LastName': 'Payne', 'Affiliation': 'Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, United Kingdom.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Szczerbińska', 'Affiliation': 'Department of Sociology of Medicine, Chair of Epidemiology and Preventive Medicine, Medical Faculty, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Department of Internal Medicine, Istituto di Medicina Interna e Geriatria, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Kylänen', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pautex', 'Affiliation': 'Hôpitaux Universitaires de Genève, Genève, Switzerland.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium.'}, {'ForeName': 'Lieve', 'Initials': 'L', 'LastName': 'Van den Block', 'Affiliation': 'End-of-Life Care Research Group, Department of Family Medicine and Chronic Care, Vrije Universiteit Brussel (VUB) and Ghent University, Brussels, Belgium.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.05.003']
1174,32650604,Nine Months of a Structured Multisport Program Improve Physical Fitness in Preschool Children: A Quasi-Experimental Study.,"Research in preschool children that investigates the impact of different exercise interventions on physical fitness is limited. This pre-post study was aimed at determining if participation in a nine-month structured multisport program (MSG; n = 38) could enhance physical fitness components compared to a formal exercise program (control group (CG); n = 36) among preschool children. Physical fitness was assessed using standardized tests (the standing long jump, sit and reach, 20 m sprint, sit-ups for 30 s, bent-arm hang, medicine ball throw (MBT), grip strength, 4 × 10 m shuttle run, and 20 m shuttle run tests). The structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week. The control group was free of any programmed exercise except for the obligatory program in kindergartens. A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p < 0.05). There was no significant group-by-time interaction effect for the 20 m sprint test ( p = 0.794) or for the 20 m shuttle run test ( p = 0.549). Moreover, the MSG and CG performance in the MBT and 20 m shuttle run tests improved to a similar extent from pre- to post-test. Our results indicate that compared to the formal plan, the structured multisport program led to a sustained improvement in physical fitness in healthy 5-to-6-year old children.",2020,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p < 0.05).","['Preschool Children', 'n = 36) among preschool children', 'healthy 5-to-6-year old children', 'preschool children']","['structured multisport program involved fundamental/gross and fine motor skills and ball game-based exercises twice a week', 'exercise interventions', 'Structured Multisport Program', 'physical fitness components compared to a formal exercise program (control group (CG']","['Physical Fitness', 'time interaction effect', 'physical fitness', 'Physical fitness', 'MSG and CG performance']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",38.0,0.019258,"A mixed ANOVA demonstrated significant group-by-time interaction effects for the 4 × 10 m shuttle run, standing long jump, sit-ups, bent-arm hang, grip strength, and sit and reach tests ( p < 0.05).","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Popović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Cvetković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Draženka', 'Initials': 'D', 'LastName': 'Mačak', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Tijana', 'Initials': 'T', 'LastName': 'Šćepanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Čokorilo', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Belić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Andrašić', 'Affiliation': 'Faculty of Economics, University of Novi Sad, 24000 Subotica, Serbia.'}, {'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Faculty of Sport, University of Ljubljana, 1000 Ljubljana, Slovenia.'}]",International journal of environmental research and public health,['10.3390/ijerph17144935']
1175,32650673,Double-blinding of an acupuncture randomized controlled trial optimized with clinical translational science award resources.,"BACKGROUND
Clinical trial articles often lack detailed descriptions of the methods used to randomize participants, conceal allocation, and blind subjects and investigators to group assignment. We describe our systematic approach to implement and measure blinding success in a double-blind phase 2 randomized controlled trial testing the efficacy of acupuncture for the treatment of vulvodynia.
METHODS
Randomization stratified by vulvodynia subtype is managed by Research Electronic Data Capture software's randomization module adapted to achieve complete masking of group allocation. Subject and acupuncturist blinding assessments are conducted multiple times to identify possible correlates of unblinding.
RESULTS
At present, 48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments.
DISCUSSION
Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.",2020,Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.,['48 subjects have been randomized and completed the protocol resulting in 87 subject and 206 acupuncturist blinding assessments'],['acupuncture'],[],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C1556023', 'cui_str': 'Acupuncturist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],,0.36601,Our approach to blinding and blinding assessment has the potential to improve our understanding of unblinding over time in the presence of possible clinical improvement.,"[{'ForeName': 'Alana D', 'Initials': 'AD', 'LastName': 'Steffen', 'Affiliation': 'Department of Health Systems Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Larisa A', 'Initials': 'LA', 'LastName': 'Burke', 'Affiliation': 'Office of Research Facilitation, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Pauls', 'Affiliation': 'Office of Research Facilitation, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Marie L', 'Initials': 'ML', 'LastName': 'Suarez', 'Affiliation': 'Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Yingwei', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Kobak', 'Affiliation': 'Department of Obstetrics and Gynecology, College of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Miho', 'Initials': 'M', 'LastName': 'Takayama', 'Affiliation': 'Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yajima', 'Affiliation': 'Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nobuari', 'Initials': 'N', 'LastName': 'Takakura', 'Affiliation': 'Department of Acupuncture and Moxibustion, Faculty of Health Sciences, Tokyo Ariake University of Medical and Health Sciences, Tokyo, Japan.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Wilkie', 'Affiliation': 'Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Schlaeger', 'Affiliation': 'Department of Women, Children and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520934910']
1176,32660159,The Effectiveness of a Dyadic Pain Management Program for Community-Dwelling Older Adults with Chronic Pain: A Pilot Randomized Controlled Trial.,"BACKGROUND
Chronic pain is a major health problem among older adults and their informal caregivers, which has negative effects on their physical and psychological status. The dyadic pain management program (DPMP) is provided to community-dwelling older adults and informal caregivers to help the dyads reduce pain symptoms, improve the quality of life, develop good exercise habits, as well as cope and break the vicious circle of pain.
METHODS
A pilot randomized controlled trial was designed and all the dyads were randomly divided into two groups: the DPMP group and control group. Dyads in the DPMP group participated in an 8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information.
RESULTS
In total, 64 dyads participated in this study. For baseline comparisons, no significant differences were found between the two groups. After the interventions, the pain score was significantly reduced from 4.25 to 2.57 in the experimental group, respectively. In the repeated measures ANOVA, the differences in pain score (F = 107.787, p < 0.001, d = 0.777) was statistically significant for the group-by-time interaction. After the interventions, the experimental group participants demonstrated significantly higher pain self-efficacy compared with the control group (F = 80.535, p < 0.001, d = 0.722). Furthermore, the elderly increased exercise time significantly (F = 111.212, p < 0.001, d = 0.782) and reported developing good exercise habits.
CONCLUSIONS
These results provide preliminary support for the effectiveness of a DPMP for relieving the symptoms of chronic pain among the elderly.",2020,"Furthermore, the elderly increased exercise time significantly (F = 111.212, p < 0.001, d = 0.782) and reported developing good exercise habits.
","['Community-Dwelling Older Adults with Chronic Pain', 'older adults and their informal caregivers', '64 dyads participated in this study', 'community-dwelling older adults and informal caregivers']","['dyadic pain management program (DPMP', 'DPMP', 'Dyadic Pain Management Program', '8-week DPMP (4-week face-to-face program and 4-week home-based program), whereas dyads in the control group received one page of simple pain-related information', 'DPMP group and control group']","['exercise time', 'pain score', 'pain self-efficacy']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013862', 'cui_str': 'Polyacrylamide gel electrophoresis'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",64.0,0.025096,"Furthermore, the elderly increased exercise time significantly (F = 111.212, p < 0.001, d = 0.782) and reported developing good exercise habits.
","[{'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Tse', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong 999007, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17144966']
1177,32649925,"Antipsychotic medication versus psychological intervention versus a combination of both in adolescents with first-episode psychosis (MAPS): a multicentre, three-arm, randomised controlled pilot and feasibility study.","BACKGROUND
Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis.
METHODS
We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433.
FINDINGS
Of 101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68·6 (SD 17·3) for antipsychotic monotherapy (6·2 points lower than at randomisation), 59·8 (13·7) for psychological intervention (13·1 points lower than at randomisation), and 62·0 (15·9) for antipsychotics plus psychological intervention (13·9 points lower than at randomisation). A good clinical response at 6 months (defined as ≥50% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial.
INTERPRETATION
This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence.
FUNDING
National Institute for Health Research.",2020,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","['101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to', 'young people with first-episode psychosis', 'adolescents with first-episode psychosis (MAPS', 'participants from seven UK National Health Service Trust sites', 'adolescents with first-episode psychosis', 'Participants were aged 14-18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service', 'The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups', 'early-onset psychosis']","['CBT', 'antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention', 'antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT', 'antipsychotic monotherapy', 'Antipsychotic medication versus psychological intervention', 'antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention', 'antipsychotics plus psychological intervention']","['feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS', 'serious adverse events', 'PANSS total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0011251', 'cui_str': 'Delusional disorder'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",61.0,0.11201,"In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment.","[{'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Morrison', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK. Electronic address: anthony.p.morrison@manchester.ac.uk.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Pyle', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK; Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Maughan', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Broome', 'Affiliation': ""Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK; Institute for Mental Health and Centre for Human Brain Health, School of Psychology, University of Birmingham, Birmingham, UK; Birmingham Women's and Children's NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Division of Psychology and Mental Health, University of Manchester, Zochonis Building, Manchester, UK; Early Intervention in Psychosis Service, Lancashire and South Cumbria NHS Foundation Trust, Chorley, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fowler', 'Affiliation': 'Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Health Sciences Building, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, University of Edinburgh Medical School, Edinburgh, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shiers', 'Affiliation': 'Psychosis Research Unit, Greater Manchester Mental Health National Health Service (NHS) Foundation Trust, Prestwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Hollis', 'Affiliation': 'National Institute for Health Research (NIHR) MindTech MedTech Co-operative and NIHR Nottingham Biomedical Research Centre, Division of Psychiatry and Applied Psychology, Institute of Mental Health, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry, Medical Sciences Division, University of Oxford, Warneford Hospital, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30248-0']
1178,32656869,Randomised clinical trial: oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn.,"BACKGROUND
Oesophageal radiofrequency reduces use of proton pump inhibitors (PPIs) in patients with gastro-oesophageal reflux disease responding to PPIs.
AIM
To determine the efficacy of oesophageal radiofrequency in patients with PPI-refractory heartburn.
METHODS
A randomised, double-blind, sham-controlled multicentre study was designed to assess the efficacy of oesophageal radiofrequency in PPI non-responding patients with heartburn. Patients had moderate-to-severe heartburn defined by at least 3 occurrences a week, and not improved by continuous PPI treatment. The primary endpoint was clinical success at week 24, defined by intake of less than 7 PPI doses over the 2 preceding weeks and adequate symptom control determined by the patient.
RESULTS
Sixty two patients were randomised, 29 to the oesophageal radiofrequency group and 33 to the sham group. Intention-to-treat analysis showed that 1/29 (3.4%) and 5/33 (15.1%) achieved the primary endpoint in the oesophageal radiofrequency and sham groups, respectively (NS). There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs. No pH-impedance parameter was associated with clinical response. The occurrence of adverse events was similar in both groups.
CONCLUSION
This sham-controlled, randomised study did not demonstrate any efficacy of oesophageal radiofrequency for the treatment of PPI-refractory heartburn regarding symptom relief or consumption of PPIs. ClinicalTrials.gov NCT01682265.",2020,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","['patients with PPI-refractory heartburn', 'PPI non-responding patients with heartburn', 'patients with gastro-oesophageal reflux disease responding to PPIs']","['oesophageal radiofrequency energy delivery versus sham for PPI-refractory heartburn', 'oesophageal radiofrequency', 'proton pump inhibitors (PPIs']","['moderate-to-severe heartburn', 'occurrence of adverse events', 'number of days without heartburn, days with PPI consumption', 'clinical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",62.0,0.307362,"There was no significant difference between oesophageal radiofrequency and sham regarding the number of days without heartburn, days with PPI consumption in the last 2 weeks, and patients not taking PPIs.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Zerbib', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Sacher-Huvelin', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Coron', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Coffin', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Melchior', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ponchon', 'Affiliation': 'Gastroenterology Department, CHU de Lyon, Hôpital Edouard Herriot, Université de Lyon, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Cholet', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Chabrun', 'Affiliation': 'Gastroenterology Department, CHU de Bordeaux, Centre Medico-chirurgical Magellan, Hôpital Haut-Lévêque, Université de Bordeaux, INSERM CIC 1401, Bordeaux, France.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Vavasseur', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gorbatchef', 'Affiliation': 'Gastroenterology Department, AP-HP, Hôpital Louis Mourier, Colombes, Université de Paris, Paris, France.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zalar', 'Affiliation': 'Gastroenterology Department, Rouen University Hospital and INSERM CIC-CRB 1404 and INSERM U1073, Institute for Research and Innovation in Biomedicine, Normandy University, Rouen, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Mion', 'Affiliation': 'Digestive Physiology Department, Hospices Civils de Lyon, Université de Lyon, Inserm U1082 LabTau, Lyon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Robaszkiewicz', 'Affiliation': 'Gastroenterology Department, CHRU de Brest, Hôpital de la Cavale Blanche, Université de Brest, Brest, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Le Rhun', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Leroy', 'Affiliation': 'Methodology and Biostatistics Department, CHU de Nantes, Université de Nantes, Nantes, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paul Galmiche', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Bruley des Varannes', 'Affiliation': ""Gastroenterology Department, CHU de Nantes, Institut des Maladies de l'Appareil Digestif (IMAD), CIC1413, Université de Nantes, Nantes, France.""}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15936']
1179,32657029,"Raltitrexed versus 5-fluorouracil with cisplatin and concurrent radiotherapy for locally advanced nasopharyngeal carcinoma: An open labeled, randomized, controlled, and multicenter clinical trial.","BACKGROUND
This study aimed to compare the efficacy and toxicity of raltitrexed (Saiweijian ® ) plus cisplatin (SP regimen) and 5-fluorouracil plus cisplatin (FP regimen) as concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).
METHODS
Eligible patients (N = 135) were allocated randomly in a ratio of 1:1 to receive CCRT with either SP or FP. At least 2 cycles of chemotherapy was administrated during radiotherapy. Progression free survival (PFS) was primary endpoint. Secondary endpoints included overall survival (OS), loco-regional relapse free survival (LRRFS), distant metastasis free survival (DMFS) and toxicity.
RESULTS
In this study, 68 patients received SP as CCRT, and 67 received FP. Objective responses were noted in 97.1% of the patients in the SP group and in 97.0% of the patients in the FP group (P = 1.00). At the end of a median 36 months follow-up period, the estimated 3-year PFS rates were 70.1% for SP and 66.6% for FP, respectively. The 3-year LRRFS, DMFS and OS rates were 88.9%, 74.7% and 84.0%, respectively, for the SP group, and 92.3%, 71.0% and 73.7%, respectively, for the FP group. Overall, there was no difference between treatment groups with regard to response or survival. The most frequent acute toxicities monitored in both groups were bone marrow suppression, gastrointestinal side effects and oral mucositis (OM). The overall incidence of grade 3-4 OM in the FP group (47.8%) was higher than in the SP group (11.8%). However, the incidence of other adverse effects observed in both groups was similar (P > .05).
CONCLUSIONS
These data indicate that SP and FP therapies have similar efficacy in treating LA-NPC. The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality. In conclusion, SP was a well tolerated, effective, regimen for LA-NPC treatment.",2020,"The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality.","['locally advanced nasopharyngeal carcinoma', 'Eligible patients (N\xa0=\xa0135', 'patients with locally advanced nasopharyngeal carcinoma (LA-NPC', '68 patients received SP as CCRT, and 67 received']","['raltitrexed (Saiweijian ® ) plus cisplatin (SP regimen) and 5-fluorouracil plus cisplatin (FP regimen', 'CCRT with either SP or FP', 'FP', 'Raltitrexed versus 5-fluorouracil with cisplatin and concurrent radiotherapy', 'chemotherapy', 'chemoradiotherapy (CCRT']","['acute toxicities', 'incidence of other adverse effects', '3-year PFS rates', 'response or survival', '3-year LRRFS, DMFS and OS rates', 'efficacy and toxicity', 'overall survival (OS), loco-regional relapse free survival (LRRFS), distant metastasis free survival (DMFS) and toxicity', 'tolerable safety profile', 'bone marrow suppression, gastrointestinal side effects and oral mucositis (OM', 'life quality', 'overall incidence of grade 3-4 OM', 'Progression free survival (PFS', 'Objective responses']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",135.0,0.0930863,"The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality.","[{'ForeName': 'Pengwei', 'Initials': 'P', 'LastName': 'Yan', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Department of Radiotherapy, Xuzhou Center Hospital, Xuzhou, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Radiotherapy, Jinling Hospital, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Shengfu', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiuhua', 'Initials': 'X', 'LastName': 'Bian', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feijiang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Fuzheng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiation Oncology, Affiliated Hospital of Jiangnan University, Wuxi, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Cancer Institute of Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Hongping', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Director of Department of Radiotherapy Oncology, Nanjing Benq Medicalcenter, Nanjing, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Radiotherapy, Xuzhou Center Hospital, Xuzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Jiang', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Juying', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Song', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}]",Cancer medicine,['10.1002/cam4.3260']
1180,32666826,Protocol adherence rates in superiority and noninferiority randomized clinical trials published in high impact medical journals.,"BACKGROUND/AIMS
Noninferiority clinical trials are susceptible to false confirmation of noninferiority when the intention-to-treat principle is applied in the setting of incomplete trial protocol adherence. The risk increases as protocol adherence rates decrease. The objective of this study was to compare protocol adherence and hypothesis confirmation between superiority and noninferiority randomized clinical trials published in three high impact medical journals. We hypothesized that noninferiority trials have lower protocol adherence and greater hypothesis confirmation.
METHODS
We conducted an observational study using published clinical trial data. We searched PubMed for active control, two-arm parallel group randomized clinical trials published in JAMA: The Journal of the American Medical Association, The New England Journal of Medicine, and The Lancet between 2007 and 2017. The primary exposure was trial type, superiority versus noninferiority, as determined by the hypothesis testing framework of the primary trial outcome. The primary outcome was trial protocol adherence rate, defined as the number of randomized subjects receiving the allocated intervention as described by the trial protocol and followed to primary outcome ascertainment (numerator), over the total number of subjects randomized (denominator). Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
RESULTS
Among 120 superiority and 120 noninferiority trials, median and interquartile protocol adherence rates were 91.5 [81.4-96.7] and 89.8 [83.6-95.2], respectively; P = 0.47. Hypothesis confirmation was observed in 107/120 (89.2%) of noninferiority and 64/120 (53.3%) of superiority trials, risk difference (95% confidence interval): 35.8 (25.3-46.3), P < 0.001.
CONCLUSION
Protocol adherence rates are similar between superiority and noninferiority trials published in three high impact medical journals. Despite this, we observed greater hypothesis confirmation among noninferiority trials. We speculate that publication bias, lenient noninferiority margins and other sources of bias may contribute to this finding. Further study is needed to identify the reasons for this observed difference.",2020,"Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
",[],['JAMA'],"['trial protocol adherence rate', 'Protocol adherence rates', 'median and interquartile protocol adherence rates']",[],[],"[{'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3.0,0.501073,"Hypothesis confirmation was defined as affirmation of noninferiority or the alternative hypothesis for noninferiority and superiority trials, respectively.
","[{'ForeName': 'Nicolas A', 'Initials': 'NA', 'LastName': 'Bamat', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Osayame A', 'Initials': 'OA', 'LastName': 'Ekhaguere', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Lingqiao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Flannery', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Handley', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Herrick', 'Affiliation': ""Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]","Clinical trials (London, England)",['10.1177/1740774520941428']
1181,32666919,"Promoting Treatment Access Following Pediatric Primary Care Depression Screening: Randomized Trial of Web-Based, Single-Session Interventions for Parents and Youths.",,2020,,"['Pediatric Primary Care Depression Screening', 'Parents and Youths']",[],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0740218', 'cui_str': 'Depression screening'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",[],[],,0.0520618,,"[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Schleider', 'Affiliation': 'Stony Brook University, New York. Electronic address: jessica.schleider@stonybrook.edu.'}, {'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Dobias', 'Affiliation': 'Stony Brook University, New York.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Fassler', 'Affiliation': 'Stony Brook University, New York.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Shroff', 'Affiliation': 'Stony Brook University, New York.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Pati', 'Affiliation': 'Division of Pediatric Primary Care, Stony Brook University, New York.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2020.01.025']
1182,32663379,Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study.,"BACKGROUND
Pancreatic cancer patients are at risk for venous thromboembolism (VTE); the value of thromboprophylaxis has not been definitively established.
METHODS
This trial randomized cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to rivaroxaban 10 mg or placebo up to day 180. This analysis examined the subset of pancreatic cancer patients. The primary efficacy endpoint was the composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death. The primary safety endpoint was International Society on Thrombosis and Haemostasis-defined major bleeding.
RESULTS
In total, 49/1080 (4.5%) patients enrolled had baseline VTE on screening, with higher rates (24/362 [6.6%]) in pancreatic cancer and they were not randomized. Of 841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period. The primary endpoint occurred in 13/135 (9.6%) patients in the rivaroxaban group and in 18/138 (13.0%) in the placebo group (hazard ratio [HR] = 0.70; 95% CI, 0.34-1.43; P = .328) in up-to-day-180 period and 5/135 (3.7%) patients receiving rivaroxaban and 14/138 (10.1%) receiving placebo in the intervention period (HR = 0.35; 95% CI, 0.13-0.97; P = .034). Major bleeding was similar (2 [1.5%] receiving rivaroxaban and 3 [2.3%] receiving placebo). Correlative biomarker studies demonstrated significant decline in D-dimer (weeks 8 and 16) in patients randomized to rivaroxaban compared to placebo (P < .01).
CONCLUSIONS
In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period. During the intervention period, however, rivaroxaban substantially reduced VTE without increasing major bleeding, suggesting benefit of rivaroxaban prophylaxis in this setting.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT02555878.",2020,"In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period.","['ambulatory patients with pancreatic cancer', 'cancer patients initiating a new regimen and at high risk for VTE (Khorana score ≥2) to', 'Pancreatic cancer patients', 'pancreatic cancer patients', '841 randomized patients, 273 (32.5%) had pancreatic cancer; 155/273 (57% in each arm) completed the double-blind period', 'ambulatory pancreatic cancer patients']","['rivaroxaban 10 mg or placebo', 'placebo', 'Rivaroxaban thromboprophylaxis', 'rivaroxaban']","['composite of symptomatic deep-vein thrombosis (DVT), asymptomatic proximal DVT, any pulmonary embolism, and VTE-related death', 'Major bleeding', 'International Society on Thrombosis and Haemostasis-defined major bleeding', 'VTE or VTE-related death']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",841.0,0.591116,"In ambulatory pancreatic cancer patients, rivaroxaban did not result in significantly lower incidence of VTE or VTE-related death in the 180-day period.","[{'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Vadhan-Raj', 'Affiliation': 'The UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.'}, {'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust & Division of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Venerito', 'Affiliation': 'Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum, Magdeburg, Germany.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Overman', 'Affiliation': 'The UT MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'The UT MD Anderson Cancer Center, Department of Sarcoma Medical Oncology, Section of Cytokines and Supportive Oncology, Houston, TX, USA.'}, {'ForeName': 'Ujjwala', 'Initials': 'U', 'LastName': 'Vijapurkar', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Simrati', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, OH, USA.'}]",Cancer medicine,['10.1002/cam4.3269']
1183,32657806,Comparative effects of neurally adjusted ventilatory assist and variable pressure support on lung and diaphragmatic function in a model of acute respiratory distress syndrome: A randomised animal study.,"BACKGROUND
Variable assisted mechanical ventilation has been shown to improve lung function and reduce lung injury. However, differences between extrinsic and intrinsic variability are unknown.
OBJECTIVE
To investigate the effects of neurally adjusted ventilatory assist (NAVA, intrinsic variability), variable pressure support ventilation (Noisy PSV, extrinsic variability) and conventional pressure-controlled ventilation (PCV) on lung and diaphragmatic function and damage in experimental acute respiratory distress syndrome (ARDS).
DESIGN
Randomised controlled animal study.
SETTING
University Hospital Research Facility.
SUBJECTS
A total of 24 juvenile female pigs.
INTERVENTIONS
ARDS was induced by repetitive lung lavage and injurious ventilation. Animals were randomly assigned to 24 h of either: 1) NAVA, 2) Noisy PSV or 3) PCV (n=8 per group). Mechanical ventilation settings followed the ARDS Network recommendations.
MEASUREMENTS
The primary outcome was histological lung damage. Secondary outcomes were respiratory variables and patterns, subject-ventilator asynchrony (SVA), pulmonary and diaphragmatic biomarkers, as well as diaphragmatic muscle atrophy and myosin isotypes.
RESULTS
Global alveolar damage did not differ between groups, but NAVA resulted in less interstitial oedema in dorsal lung regions than Noisy PSV. Gas exchange and SVA incidence did not differ between groups. Compared with Noisy PSV, NAVA generated higher coefficients of variation of tidal volume and respiratory rate. During NAVA, only 40.4% of breaths were triggered by the electrical diaphragm signal. The IL-8 concentration in lung tissue was lower after NAVA compared with PCV and Noisy PSV, whereas Noisy PSV yielded lower type III procollagen mRNA expression than NAVA and PCV. Diaphragmatic muscle fibre diameters were smaller after PCV compared with assisted modes, whereas expression of myosin isotypes did not differ between groups.
CONCLUSION
Noisy PSV and NAVA did not reduce global lung injury compared with PCV but affected different biomarkers and attenuated diaphragmatic atrophy. NAVA increased the respiratory variability; however, NAVA yielded a similar SVA incidence as Noisy PSV.
TRIAL REGISTRATION
This trial was registered and approved by the Landesdirektion Dresden, Germany (AZ 24-9168.11-1/2012-2).",2021,"Diaphragmatic muscle fibre diameters were smaller after PCV compared with assisted modes, whereas expression of myosin isotypes did not differ between groups.
","['acute respiratory distress syndrome', 'A total of 24 juvenile female pigs', 'University Hospital Research Facility', 'experimental acute respiratory distress syndrome (ARDS']","['Noisy PSV, NAVA', 'NAVA, 2) Noisy PSV or 3) PCV', 'NAVA', 'neurally adjusted ventilatory assist and variable pressure support', 'neurally adjusted ventilatory assist (NAVA, intrinsic variability), variable pressure support ventilation (Noisy PSV, extrinsic variability) and conventional pressure-controlled ventilation (PCV']","['respiratory variables and patterns, subject-ventilator asynchrony (SVA), pulmonary and diaphragmatic biomarkers, as well as diaphragmatic muscle atrophy and myosin isotypes', 'variation of tidal volume and respiratory rate', 'IL-8 concentration in lung tissue', 'Diaphragmatic muscle fibre diameters', 'interstitial oedema', 'lung and diaphragmatic function', 'type III procollagen mRNA expression', 'global lung injury', 'Gas exchange and SVA incidence', 'histological lung damage', 'expression of myosin isotypes', 'Global alveolar damage']","[{'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0027096', 'cui_str': 'Myosin ATPase'}, {'cui': 'C0021017', 'cui_str': 'Immunoglobulin isotype'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0033240', 'cui_str': 'Procollagen Type III'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0010957', 'cui_str': 'Damage'}]",24.0,0.110738,"Diaphragmatic muscle fibre diameters were smaller after PCV compared with assisted modes, whereas expression of myosin isotypes did not differ between groups.
","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Scharffenberg', 'Affiliation': ''}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Moraes', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Güldner', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Huhle', 'Affiliation': ''}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Braune', 'Affiliation': ''}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Zeidler-Rentzsch', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kasper', 'Affiliation': ''}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Kunert-Keil', 'Affiliation': ''}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pelosi', 'Affiliation': ''}, {'ForeName': 'Patricia R M', 'Initials': 'PRM', 'LastName': 'Rocco', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Gama de Abreu', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kiss', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001261']
1184,32659365,Interlaminar stabilization for spinal stenosis in the Medicare population.,"BACKGROUND CONTEXT
The number of complex fusions performed on Medicare beneficiaries, defined as ≥age 65, with lumbar spinal stenosis with or without spondylolisthesis has been increasing. Typically, these procedures are longer, more invasive and pose a greater risk for complications. Interlaminar stabilization (ILS) serves as an intermediary between decompression alone and decompression with fusion.
PURPOSE
The purpose of this study was to prospectively examine the efficacy of ILS in patients ≥age 65 through comparison to fusion in the same age group and ILS in younger patients.
STUDY DESIGN/SETTING
A prospective, multicentered, randomized controlled trial comparing decompression with ILS to decompression with posterolateral fusion with bilateral pedicle screw instrumentation.
PATIENT SAMPLE
Patients from 21 sites in the United States underwent surgery for moderate stenosis with up to a grade 1 degenerative spondylolisthesis and failure of conservative treatment with low back pain at 1 or 2 contiguous levels from L1-L5. Preoperatively, patient-reported assessment had to meet the criteria of significant pain and disability (Visual Analog Scale [VAS back pain] ≥50 mm on a 100 mm scale; Oswestry Disability Index [ODI] of ≥20/50).
OUTCOME MEASURES
The primary outcome was overall Composite Clinical Success (CCS) as determined by ODI scores, incidence of postoperative epidural injections and/or reoperations, incidence of device-related complications, and persistent or progressive neurological deficit. Secondary outcomes included patient satisfaction as measured by VAS for back and worse leg pain and Zurich Claudication Questionnaire scores. Narcotic usage data and radiographic assessment of changes in postoperative posterior disc height and foraminal height were also evaluated.
METHODS
At 1- or 2-levels, 84 patients ≥age 65 underwent decompression with ILS, 57 patients ≥age 65 underwent decompression with fusion, and 131 patients 0.050). WB-EMS showed a favorable isolated effect on the development of power and velocity, but it induced negligible effects on the body composition of postmenopausal women.",2020,score improvements than the other group ( p Bonferroni < 0.05).,"['Postmenopausal Women', 'postmenopausal women', 'Thirty-four healthy sedentary women between 55 and 69 years followed an experimental design pre-post test']","['whole-body electromyostimulation (WB-EMS', 'Whole Body Electromyostimulation', 'training with superimposed WB-EMS during exercise', 'aerobic and strength training program']","['body composition', 'Velocity, Power and Body Composition', 'score improvements', 'physical activity time']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0032919', 'cui_str': 'Pre-Post Tests'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",34.0,0.0381312,score improvements than the other group ( p Bonferroni < 0.05).,"[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pano-Rodriguez', 'Affiliation': 'Research Group Human Movement, University of Lleida, E-25001 Lleida, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Beltran-Garrido', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, 43870 Tarragona, Spain.'}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Hernandez-Gonzalez', 'Affiliation': 'Nutritional Coaching SL, 08011 Barcelona, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Nasarre-Nacenta', 'Affiliation': 'Nutritional Coaching SL, 08011 Barcelona, Spain.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Reverter-Masia', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, 43870 Tarragona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17144982']
1201,32680812,The effect of manual lymphatic drainage on patient recovery after orthognathic surgery-A qualitative and 3-dimensional facial analysis.,"OBJECTIVE
The aim of this study was to investigate the effect of manual lymphatic drainage (MLD) on postoperative facial swelling and pain.
STUDY DESIGN
A randomized, single-center, prospective, 2-arm clinical trial with blinded endpoint assessment was set up. Patients were enrolled from the Maxillofacial Department of the Ghent University Hospital (Belgium) between January 2015 and March 2018. Both the intervention group (n = 13) and the control group (n = 13) received the same postoperative care; in addition, the intervention group underwent 6 sessions of MLD after orthognathic surgery. Three-dimensional facial scans were performed and questionnaires administered on postoperative days 3, 7, 14, 30, 90, and 180. A linear mixed model was performed, and statistical significance was assumed at the 5% level.
RESULTS
In total, 26 patients (mean age 29 years; range 16-57 years) were included for statistical analysis. A faster decrease in swelling in the intervention group was observed on 3-dimensional scans. Furthermore, patients receiving MLD reported reduction in swelling and pain within the first month after surgery. However, no statistically significant difference could be detected in these observations (P > .05).
CONCLUSIONS
Within the limitations of this study, no statistically significant difference could be found between patients treated with or without MLD after orthognathic surgery with regard to swelling and pain.",2020,A faster decrease in swelling in the intervention group was observed on 3-dimensional scans.,"['Patients were enrolled from the Maxillofacial Department of the Ghent University Hospital (Belgium) between January 2015 and March 2018', '26 patients (mean age 29 years; range 16-57 years']","['manual lymphatic drainage', 'manual lymphatic drainage (MLD', 'MLD']","['swelling', 'swelling and pain', 'postoperative facial swelling and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}]","[{'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}]",26.0,0.0811295,A faster decrease in swelling in the intervention group was observed on 3-dimensional scans.,"[{'ForeName': 'Fréderic E G', 'Initials': 'FEG', 'LastName': 'Van de Velde', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium. Electronic address: Frederic.vandevelde@ugent.be.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Ortega-Castrillon', 'Affiliation': 'Department of Electrical Engineering, ESAT/PSI, KU Leuven, Heverlee, Belgium; Medical Imaging Research Center, MIRC, UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'Laurent A M', 'Initials': 'LAM', 'LastName': 'Thierens', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Claes', 'Affiliation': ""Department of Electrical Engineering, ESAT/PSI, KU Leuven, Heverlee, Belgium; Medical Imaging Research Center, MIRC, UZ Leuven, Leuven, Belgium; Murdoch Children's Research Institute, Melbourne, Australia.""}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'De Pauw', 'Affiliation': 'Department of Orthodontics, Oral Health Sciences, Ghent University, Ghent University Hospital, Ghent, Belgium.'}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.05.017']
1202,32670196,A Comprehensive Intervention for Promoting Successful Aging Amongst Older People With Diabetes With Below-Normal Cognitive Function-A Feasibility Study.,"Background: Older people with diabetes have an increased risk for disability and cognitive dysfunction, which may impede self-care capacity. These are not evaluated routinely in current health systems. In the Center for Successful Aging with Diabetes, patients over the age of 60 undergo multi-disciplinary evaluation days and are provided with an integrated (cognitive, physical, nutritional, and medical) treatment plan. Among individuals with below-normal cognitive function, self-adherence to these recommendations poses a challenge. Thus, the aim of this study was to test the feasibility of a multidisciplinary intervention amongst older people with diabetes with below-normal cognitive function and sub-optimal glucose control. Methods: Patients with a MoCA score under 26 and A1C >= 7.5% participated in a two-arm intervention: (A) a medical intervention: monthly meetings with a diabetes nurse-educator, supervised by a diabetes specialist and study psychologist during which changes in their pharmacological regimen of glucose, blood pressure, and lipid control were made and (B) a cognitive/physical rehabilitation intervention. This arm consisted of (1) an intensive phase-group meetings which included computerized cognitive training, aerobic, balance, and strength exercise, and group discussions and (2) a monthly consolidation phase. Outcomes included change in A1C, change in strength, balance, and aerobic exercise capacity as well as change in quality of life. Results: After 12 months there was a 0.7% reduction in A1C. After 3 months there was a statistically significant improvement in physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go). There was no additional improvement in physical indices between the 3 and 12 month visits. For some of the physical measures, the improvement observed after 3 months persisted partially to the 12-month visit. Conclusions: This feasibility study provides preliminary data that support the efficacy of the complex interventions described. The findings suggest that this older population would require an ongoing ""intensive phase"" intervention. Larger prospective randomized trials are needed.",2020,"After 3 months there was a statistically significant improvement in physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go).","['Older people with diabetes', 'older people with diabetes with below-normal cognitive function and sub-optimal glucose control', 'Older People With Diabetes', 'Patients with a MoCA score under 26 and A1C >= 7.5% participated in a two-arm intervention: (A) a']","['medical intervention: monthly meetings with a diabetes nurse-educator, supervised by a diabetes specialist and study psychologist during which changes in their pharmacological regimen of glucose, blood pressure, and lipid control were made and (B) a cognitive/physical rehabilitation intervention', 'multidisciplinary intervention', 'Comprehensive Intervention', 'intensive phase-group meetings which included computerized cognitive training, aerobic, balance, and strength exercise, and group discussions and (2) a monthly consolidation phase']","['physical indices', 'change in A1C, change in strength, balance, and aerobic exercise capacity as well as change in quality of life', 'physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4047815', 'cui_str': 'Below normal'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015538', 'cui_str': 'Nurse teacher'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",,0.0189277,"After 3 months there was a statistically significant improvement in physical indices, including aerobic capacity (6-min walk), balance (FSST) and indices assessing the risk of fall (10-meter walk, time up and go).","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Natovich', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Gayus', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Azmon', 'Affiliation': 'The Physiotherapy Department, Faculty of Health Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Hila', 'Initials': 'H', 'LastName': 'Michal', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Omri', 'Initials': 'O', 'LastName': 'Gury Twito', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Tomer', 'Initials': 'T', 'LastName': 'Yair', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Raudoi', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Kapra', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Cukierman-Yaffe', 'Affiliation': 'Endocrinology Division, The Center for Successful Aging With Diabetes, Sheba Medical Center, Gertner Institute, Ramat Gan, Israel.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00348']
1203,32671864,Editorial Comment to Transient stent placement versus tubeless procedure after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study 2): A randomized prospective evaluation.,,2020,,['after ureteroscopy retrograde surgery stone extraction (Fast Track Stent study\xa02'],['Transient stent placement versus tubeless procedure'],[],"[{'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",[],,0.0348151,,"[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Department of Urology and Andrology, Kansai Medical University Hospital, Hirakata, Osaka, Japan.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14309']
1204,32668499,"Effect of botulinum toxin type A for treating hypertrophic scars: A split-scar, double-blind randomized controlled trial.","BACKGROUND
Hypertrophic scars (HS) are a challenging disorder that mostly develops during wound-healing process following skin injuries.
METHODS
A split-scar, double-blind randomized controlled trial was held to assess the safety and efficacy of botulinum toxin type A (BTA) injection in hypertrophic scars (HS). Thirty patients with old scars (range: 1-15 years) were treated, with sides randomized to receive treatment with either BTA or 0.9% normal saline once monthly for three consecutive months. Scars were assessed using the Vancouver scar scale (VSS) along with digital photograph standardization.
RESULTS
Twenty-one subjects completed the study. The mean VSS score for the BTA-treated half of the scars decreased from 7.29 ± 2.327 before injection to 5.33 ± 2.41 following injection which was highly significant (P = .01). For the control half, the mean VSS decreased insignificantly from 7.29 ± 2.327 before injection to 7.10 ± 2.234 following injection (P = .104).
CONCLUSION
Clinical and cosmetic improvement was demonstrated significantly among the BTA-treated group. BTA can be an additional and useful tool for improving scar outcomes.",2020,"For the control half, the mean VSS decreased insignificantly from 7.29±2.327 before injection to 7.10±2.234 following injection (p = 0.104).
","['hypertrophic scars (HS', 'Thirty patients with old scars (range 1-15years', ' Twenty one subjects completed the study', 'hypertrophic scars']","['botulinum toxin type A (BTA) injection', 'BTA', 'BTA or 0.9% normal saline', 'Botulium toxin type A']","['safety and efficacy', 'mean VSS score', 'Vancouver scar scale (VSS', 'mean VSS']","[{'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0445349', 'cui_str': 'Toxin typing'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.351475,"For the control half, the mean VSS decreased insignificantly from 7.29±2.327 before injection to 7.10±2.234 following injection (p = 0.104).
","[{'ForeName': 'Ahmad R', 'Initials': 'AR', 'LastName': 'Elshahed', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Elmanzalawy', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Shehata', 'Affiliation': 'Department of Dermatology and Venereology, National Research Centre, Giza, Egypt.'}, {'ForeName': 'Mohamed L', 'Initials': 'ML', 'LastName': 'ElSaie', 'Affiliation': 'Department of Dermatology and Venereology, National Research Centre, Giza, Egypt.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13627']
1205,32676976,Exploring an Integrative Therapy for Treating COVID-19: A Randomized Controlled Trial.,"OBJECTIVES
To develop a new Chinese medicine (CM)-based drug and to evaluate its safety and effect for suppressing acute respiratory distress syndrome (ARDS) in COVID-19 patients.
METHODS
A putative ARDS-suppressing drug Keguan-1 was first developed and then evaluated by a randomized, controlled two-arm trial. The two arms of the trial consist of a control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir, 400 and 100 mg twice daily, respectively) and a testing therapy (control therapy plus Keguan-1 19.4 g twice daily) by random number table at 1:1 ratio with 24 cases each group. After 2-week treatment, adverse events, time to fever resolution, ARDS development, and lung injury on newly diagnosed COVID-19 patients were assessed.
RESULTS
An analysis of the data from the first 30 participants showed that the control arm and the testing arm did not exhibit any significant differences in terms of adverse events. Based on this result, the study was expanded to include a total of 48 participants (24 cases each arm). The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
CONCLUSIONS
Keguan-1-based integrative therapy was safe and superior to the standard therapy in suppressing the development of ARDS in COVID-19 patients. (Trial registration No. NCT04251871 at www.clinicaltrials.gov ).",2020,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","['48 participants (24 cases each arm', 'COVID-19 patients']","['control therapy (alpha interferon inhalation, 50 µg twice daily; and lopinavir/ritonavir', 'Keguan-1-based integrative therapy']","['adverse events', 'development of ARDS', 'adverse events, time to fever resolution, ARDS development, and lung injury', 'time to fever resolution']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}]",48.0,0.271286,"The results show that compared with the control arm, the testing arm exhibited a significant improvement in time to fever resolution (P=0.035), and a significant reduction in the development of ARDS (P=0.048).
","[{'ForeName': 'Jia-Bo', 'Initials': 'JB', 'LastName': 'Wang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhong-Xia', 'Initials': 'ZX', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Hui', 'Initials': 'JH', 'LastName': 'Dong', 'Affiliation': 'Department of Radiology, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Feng', 'Initials': 'YF', 'LastName': 'Zhou', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Niu', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Tian-Jun', 'Initials': 'TJ', 'LastName': 'Jiang', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jing-Feng', 'Initials': 'JF', 'LastName': 'Bi', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zhao-Fang', 'Initials': 'ZF', 'LastName': 'Bai', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Guo', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Si-Miao', 'Initials': 'SM', 'LastName': 'Yu', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Yong-Qiang', 'Initials': 'YQ', 'LastName': 'Sun', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Zi-Teng', 'Initials': 'ZT', 'LastName': 'Zhang', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Zhan', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Yan', 'Initials': 'PY', 'LastName': 'Li', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jin-Biao', 'Initials': 'JB', 'LastName': 'Ding', 'Affiliation': 'Research Center for Clinical and Translational Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Peng-Fei', 'Initials': 'PF', 'LastName': 'Zhao', 'Affiliation': 'College of Life Science, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Xue-Ai', 'Initials': 'XA', 'LastName': 'Song', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China.'}, {'ForeName': 'Jian-Yuan', 'Initials': 'JY', 'LastName': 'Tang', 'Affiliation': 'Sichuan Evidence-Based Medicine Center of Traditional Chinese Medicine Affliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.'}, {'ForeName': 'Dong-Chu', 'Initials': 'DC', 'LastName': 'He', 'Affiliation': 'Department of Integrated Treatment, General Hospital of Central Theater Command, Wuhan, 430070, China.'}, {'ForeName': 'Zhu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'National Clinical Research Center for Infectious Diseases, Beijing, 100039, China.'}, {'ForeName': 'En-Qiang', 'Initials': 'EQ', 'LastName': 'Qin', 'Affiliation': 'Treatment and Research Center for Infectious Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. qeq2004@sina.com.'}, {'ForeName': 'Rui-Lin', 'Initials': 'RL', 'LastName': 'Wang', 'Affiliation': 'Integrative Medical Center, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. wrl7905@163.com.'}, {'ForeName': 'Xiao-He', 'Initials': 'XH', 'LastName': 'Xiao', 'Affiliation': 'China Military Institute of Chinese Medicine, The Fifth Medical Center of Chinese PLA General Hospital, Beijing, 100039, China. pharmacy302xxh@126.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3426-7']
1206,32673496,The Arousal Threshold as a Drug Target to Improve Continuous Positive Airway Pressure Adherence: Secondary Analysis of a Randomized Trial.,,2020,,[],[],['CPAP Adherence'],[],[],"[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.20808,,"[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Schmickl', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lettieri', 'Affiliation': 'Uniformed Services University of the Health Sciences, Bethesda, Maryland and.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeYoung', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'University of California San Diego, San Diego, California.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'University of California San Diego, San Diego, California.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202003-0502LE']
1207,32679370,Early application of caffeine improves white matter development in very preterm infants.,"The aim of this study was to evaluate the effect of early prophylactic caffeine treatment on white matter development in very preterm infants using cerebral magnetic resonance imaging. A total of 194 preterm infants (≤32 weeks gestational age) were randomly assigned to the caffeine (n = 96) or placebo (n = 93) treatment group and administered with either caffeine or placebo within 72 h after birth. Cerebral magnetic resonance imaging, including diffuse tensor imaging examination, was performed at 34-36 weeks of corrected gestational age, and the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were measured. In total, 160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group. There were fewer instances of apnea of prematurity and shorter assisted ventilation times for infants in the caffeine group compared to the placebo group (p < 0.05). Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group. ADC values in the above white matter areas were significantly reduced in the caffeine group. However, there were no significant differences regarding the FA and ADC in the gray matter between the two groups. These results demonstrate that early administration of caffeine improves white matter micro-structural development in preterm infants, but with no significant effect on short-term complications related to prematurity.",2020,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","['very preterm infants', 'very preterm infants using cerebral magnetic resonance imaging', 'preterm infants', '194 preterm infants (≤32 weeks gestational age', '160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group']","['placebo', 'caffeine', 'caffeine or placebo', 'prophylactic caffeine']","['white matter micro-structural development', 'apnea of prematurity and shorter assisted ventilation times', 'FA values', 'fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values', 'FA and ADC', 'ADC values']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",194.0,0.144528,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","[{'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Ruili', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Perinatal Medicine and Health, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden.'}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm 17177, Sweden. Electronic address: changlian.zhu@neuro.gu.se.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103495']
1208,32681547,Effect of a high protein/low glycaemic index diet on insulin resistance in adolescents with overweight/obesity-A PREVIEW randomized clinical trial.,"BACKGROUND
Pubertal insulin resistance (IR) is associated with increased risk of type 2 diabetes mellitus development in adolescents with overweight/obesity.
OBJECTIVES
The PREVIEW study was a randomized parallel trial assessing the change in IR, analyzed by Homeostatic Model Assessment of IR (HOMA-IR), at 2 years after randomization to a high protein vs a moderate protein diet in adolescents with overweight/obesity. It was hypothesized that a high protein/low glycaemic index diet would be superior in reducing IR compared to a medium protein/medium GI diet, in insulin resistant adolescents with overweight or obesity.
METHODS
Adolescents with overweight/obesity and IR from the Netherlands, United Kingdom and Spain were randomized into a moderate protein/moderate GI (15/55/30En% protein/carbohydrate/fat, GI ≥ 56) or high protein/low GI (25/45/30En% protein/carbohydrate/fat, GI < 50) diet. Anthropometric and cardiometabolic parameters, puberty, dietary intake and physical activity (PA) were measured and effects on HOMA-IR were analyzed.
RESULTS
126 adolescents were included in this study (13.6 ± 2.2 years, BMI z-score 3.04 ± 0.66, HOMA-IR 3.48 ± 2.28, HP n = 68, MP n = 58). At 2 years, changes in protein intake were not significantly different between timepoints or intervention groups and no effects of the intervention on IR were observed. The retention rate was 39%, while no compliance to the diets was observed.
CONCLUSIONS
The PREVIEW study observed no effect of a high protein/low GI diet on IR in adolescents with overweight/obesity and IR because of lack of feasibility, due to insufficient retention and dietary compliance after 2 years.",2021,"At 2 years, changes in protein intake were not significantly different between timepoints or intervention groups and no effects of the intervention on IR were observed.","['adolescents with overweight/obesity', '126 adolescents were included in this study (13.6\u2009±\u20092.2\u2009years, BMI z-score 3.04\u2009±\u20090.66, HOMA-IR 3.48\u2009±\u20092.28, HP n = 68, MP n = 58', 'Adolescents with overweight/obesity and IR from the Netherlands, United Kingdom and Spain']","['high protein/low GI diet', 'high protein vs a moderate protein diet', 'high protein/low glycaemic index diet', 'moderate protein/moderate GI (15/55/30En% protein/carbohydrate/fat, GI\u2009≥\u200956) or high protein/low GI (25/45/30En% protein/carbohydrate/fat, GI\u2009<\u200950) diet']","['HOMA-IR', 'insulin resistance', 'changes in protein intake', 'Anthropometric and cardiometabolic parameters, puberty, dietary intake and physical activity (PA', 'retention rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0452269', 'cui_str': 'Protein diet'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034011', 'cui_str': 'Puberty'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",126.0,0.0139449,"At 2 years, changes in protein intake were not significantly different between timepoints or intervention groups and no effects of the intervention on IR were observed.","[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Dorenbos', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Drummen', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Adam', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Rijks', 'Affiliation': ""Centre for Overweight Adolescent and Children's Healthcare (COACH), Maastricht University Medical Centre, Maastricht, The Netherlands.""}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'Department of Nutrition, Food Science and Physiology, Centre for Nutrition Research (CIN), Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Navas-Carretero', 'Affiliation': 'Department of Nutrition, Food Science and Physiology, Centre for Nutrition Research (CIN), Universidad de Navarra, Pamplona, Spain.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Stratton', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Swindell', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Stouthart', 'Affiliation': ""Centre for Overweight Adolescent and Children's Healthcare (COACH), Maastricht University Medical Centre, Maastricht, The Netherlands.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mackintosh', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Melitta', 'Initials': 'M', 'LastName': 'Mcnarry', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine (A-STEM), Swansea University, Swansea, UK.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Department of Kinesiology, Université Laval, Québec, Canada.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Fogelholm', 'Affiliation': 'Department of Food and Nutrition, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg, Denmark.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Westerterp-Plantenga', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Vreugdenhil', 'Affiliation': 'NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, Maastricht, The Netherlands.'}]",Pediatric obesity,['10.1111/ijpo.12702']
1209,33239067,Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis.,"BACKGROUND
The Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) double blind randomized trial demonstrated that weekly subcutaneous dulaglutide 1.5 mg, a glucagon like peptide-1 receptor agonist, versus matched placebo reduced the first outcome of major adverse cardiovascular event (MACE), cardiovascular death, nonfatal myocardial infarction or nonfatal stroke (594 versus 663 events) in 9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4 years. These findings were based on a time-to-first-event analysis and preclude relevant information on the burden of total major events occurring during the trial. This analysis reports on the total cardiovascular or fatal events in the REWIND participants METHODS: We compared the total incidence of MACE or non-cardiovascular deaths, and the total incidence of expanded MACE (MACE, unstable angina, heart failure or revascularization) or non-cardiovascular deaths between participants randomized to dulaglutide and those randomized to placebo. Incidences were expressed as number per 1000 person-years. Hazard ratios (HR) were calculated using the conditional time gap and proportional means models.
RESULTS
Participants had a mean age of 66.2 years, 46.3% were women and 31% had previous cardiovascular disease. During the trial there were 1972 MACE or non-cardiovascular deaths and 3673 expanded MACE or non-cardiovascular deaths. The incidence of total MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 35.8 and 40.3 per 1000 person-years, respectively [absolute reduction = 4.5 per 1000 person-years; conditional time gap HR 0.90 (95% CI, 0.82-0.98) p = 0.020, and proportional means HR 0.89 (95% CI, 0.80-0.98) p = 0.022]. The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87-0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82-0.99) p = 0.028].
CONCLUSIONS
These findings suggest that weekly subcutaneous dulaglutide reduced total cardiovascular or fatal event burden in people with type 2 diabetes at moderate cardiovascular risk.
CLINICAL TRIAL REGISTRATION
https://www.clinicaltrials.gouv . Unique Identifier NCT01394952).",2020,"The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87-0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82-0.99) p = 0.028].
","['people with type 2 diabetes at moderate cardiovascular risk', '9901 persons with type 2 diabetes and either chronic cardiovascular disease or risk factors, and followed during 5.4\xa0years', 'people with type 2 diabetes and cardiovascular risk factors treated with', 'Diabetes (REWIND', 'Participants had a mean age of 66.2\xa0years, 46.3% were women and 31% had previous cardiovascular disease']","['subcutaneous dulaglutide 1.5\xa0mg, a glucagon like peptide-1 receptor agonist, versus matched placebo', 'placebo', 'dulaglutide']","['major adverse cardiovascular event (MACE), cardiovascular death, nonfatal myocardial infarction or nonfatal stroke', 'incidence of total expanded MACE or non-cardiovascular deaths', 'total cardiovascular or fatal event burden', 'total incidence of MACE or non-cardiovascular deaths', 'incidence of total MACE or non-cardiovascular deaths', 'Total cardiovascular or fatal events', 'Hazard ratios (HR', 'total cardiovascular or fatal events', 'total incidence of expanded MACE (MACE, unstable angina, heart failure or revascularization']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C1562292', 'cui_str': 'Incretin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",9901.0,0.274516,"The incidence of total expanded MACE or non-cardiovascular deaths in the dulaglutide and placebo groups was 67.1 and 74.7 per 1000 person-years, respectively [absolute reduction = 7.6 per 1000 person-years; conditional time gap HR 0.93 (95% CI, 0.87-0.99) p = 0.023, and proportional means HR 0.90 (95% CI, 0.82-0.99) p = 0.028].
","[{'ForeName': 'Gilles R', 'Initials': 'GR', 'LastName': 'Dagenais', 'Affiliation': 'Clinical Research Center, Laval University, Quebec Heart and Lung Institute, 2725, chemin Ste-Foy, Quebec City, Qc, GIV 4G5, Canada. gilles.dagenais@criucpq.ulaval.ca.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine Solna, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, In, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, ON, Canada.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine (Cardiology), University of Washington Medical Centre, Seattle, WA, USA.'}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, In, USA.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clinic i Universitari, Barcelona, Spain.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Department of Medicine, University of Tennessee Health Science, Memphis, TN, USA.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander UDES, Bucaramanga, Colombia.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Universidad de la Frontera, Temuco, Chile.'}, {'ForeName': 'Ernesto German Cordona', 'Initials': 'EGC', 'LastName': 'Munoz', 'Affiliation': 'Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico.'}, {'ForeName': 'Valdis', 'Initials': 'V', 'LastName': 'Pirags', 'Affiliation': 'Latvijas Universitate, Riga, Latvia.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Centre of Cardiology, Moscow, Russia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Charleston and Ralph H Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Wayne H H', 'Initials': 'WHH', 'LastName': 'Sheu', 'Affiliation': 'Endocrinology and Metabolism, Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Centre, Sofia, Bulgaria.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, ON, Canada.'}, {'ForeName': 'Prem', 'Initials': 'P', 'LastName': 'Pais', 'Affiliation': ""St John's Research Institute, Bangalore, India.""}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'MRC Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon and Health Science University, Portland, OR, USA.'}, {'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Science, Hamilton, ON, Canada.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01179-1']
1210,33239079,"Feasibility and initial efficacy of a high-intensity interval training program using adaptive equipment in persons with multiple sclerosis who have walking disability: study protocol for a single-group, feasibility trial.","BACKGROUND
There is considerable evidence for the efficacy of moderate-intensity continuous exercise benefitting clinically relevant outcomes in persons with multiple sclerosis (MS). However, persons with MS who have walking disability (pwMS-wd) are severely deconditioned and may achieve superior benefits by engaging in high-intensity interval training (HIIT), especially while utilizing adaptive equipment, such as recumbent arm/leg stepping (RSTEP). The proposed study will assess the feasibility of a 12-week, RSTEP HIIT program in pwMS-wd. The secondary aim will examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depression as clinically relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention.
METHODS
The study will recruit 15 pwMS-wd. Feasibility will be measured via process, resource, management, and scientific outcomes throughout the entirety of the research study. The secondary, clinically relevant outcomes will consist of a neurological exam, aerobic capacity, physical activity, ambulation, cognition, upper arm function, fatigue, and depression. Outcomes will be assessed at baseline (T1), midpoint (T2, following 6 weeks), and post-intervention (T3, following 12 weeks). The intervention will involve 12 weeks of supervised, individualized HIIT sessions two to three times per week. The individual HIIT sessions will each involve 10 cycles of 60-s intervals at the wattage associated with 90% VO 2peak followed by 60 s of active recovery intervals at 15 W, totaling 20 min in length plus 5-min warm-up and cool-down periods.
DISCUSSION
The feasibility design of the proposed study will provide experience and preliminary data for advancing towards a proof-of-concept study comparing HIIT to moderate-intensity continuous RSTEP for improving clinically relevant outcomes in a randomized control trial design. The results will be disseminated via manuscripts for publication and a report for distribution among the National Multiple Sclerosis Society.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04416243 . Retrospectively registered on June 4, 2020.",2020,"The secondary aim will examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depression as clinically relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention.
","['persons with multiple sclerosis (MS', 'persons with multiple sclerosis who have walking disability', 'persons with MS who have walking disability (pwMS-wd']","['RSTEP HIIT program', 'high-intensity interval training program']","['neurological exam, aerobic capacity, physical activity, ambulation, cognition, upper arm function, fatigue, and depression', 'Feasibility and initial efficacy', 'aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depression as clinically relevant efficacy outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0311394', 'cui_str': 'Difficulty walking'}]","[{'cui': 'C0444334', 'cui_str': 'Recumbent body position'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.067575,"The secondary aim will examine changes in aerobic fitness, physical activity, ambulation, upper arm function, cognition, fatigue, and depression as clinically relevant efficacy outcomes following the 12-week, RSTEP HIIT intervention.
","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hubbard', 'Affiliation': 'Department of Kinesiology, Berry College, Mount Berry, GA, USA. lhubbard@berry.edu.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Elmer', 'Affiliation': 'Department of Kinesiology, Berry College, Mount Berry, GA, USA.'}]",Trials,['10.1186/s13063-020-04887-x']
1211,33074237,Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial.,"BACKGROUND
In preclinical models, benfotiamine efficiently ameliorates the clinical and biological pathologies that define Alzheimer's disease (AD) including impaired cognition, amyloid-β plaques, neurofibrillary tangles, diminished glucose metabolism, oxidative stress, increased advanced glycation end products (AGE), and inflammation.
OBJECTIVE
To collect preliminary data on feasibility, safety, and efficacy in individuals with amnestic mild cognitive impairment (aMCI) or mild dementia due to AD in a placebo-controlled trial of benfotiamine.
METHODS
A twelve-month treatment with benfotiamine tested whether clinical decline would be delayed in the benfotiamine group compared to the placebo group. The primary clinical outcome was the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). Secondary outcomes were the clinical dementia rating (CDR) score and fluorodeoxyglucose (FDG) uptake, measured with brain positron emission tomography (PET). Blood AGE were examined as an exploratory outcome.
RESULTS
Participants were treated with benfotiamine (34) or placebo (36). Benfotiamine treatment was safe. The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125). Worsening in CDR was 77% lower (p = 0.034) in the benfotiamine group compared to the placebo group, and this effect was stronger in the APOEɛ4 non-carriers. Benfotiamine significantly reduced increases in AGE (p = 0.044), and this effect was stronger in the APOEɛ4 non-carriers. Exploratory analysis derivation of an FDG PET pattern score showed a treatment effect at one year (p = 0.002).
CONCLUSION
Oral benfotiamine is safe and potentially efficacious in improving cognitive outcomes among persons with MCI and mild AD.",2020,"The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125).","[""Alzheimer's Disease"", 'persons with MCI and mild AD', 'individuals with amnestic mild cognitive impairment (aMCI) or mild dementia due to AD in a placebo-controlled trial of benfotiamine', 'Participants were treated with benfotiamine (34) or']","['Oral benfotiamine', 'benfotiamine', 'placebo', 'Benfotiamine', 'Placebo']","['Worsening in CDR', ""Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog"", 'AGE', 'FDG PET pattern score', 'cognitive outcomes', 'clinical dementia rating (CDR) score and fluorodeoxyglucose (FDG) uptake, measured with brain positron emission tomography (PET', 'Blood AGE', 'ADAS-Cog', 'feasibility, safety, and efficacy']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0053116', 'cui_str': 'benphothiamine'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0053116', 'cui_str': 'benphothiamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0451074', 'cui_str': 'Clinical dementia rating scale'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's Disease Assessment Scale""}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation End Products'}, {'cui': 'C3641247', 'cui_str': 'FDG PET scan'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.417553,"The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p = 0.125).","[{'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Gibson', 'Affiliation': 'Brain and Mind Research Institute, Weil Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Luchsinger', 'Affiliation': 'Departments of Medicine and Epidemiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Cirio', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Huanlian', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Franchino-Elder', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Hirsch', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Lucien', 'Initials': 'L', 'LastName': 'Bettendorff', 'Affiliation': 'Laboratory of Neurophysiology, GIGA-Neurosciences, University of Liege, Belgium.'}, {'ForeName': 'Zhengming', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Flowers', 'Affiliation': 'Department of Neuroscience, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Gerber', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Grandville', 'Affiliation': 'Burke Rehabilitation Hospital, White Plains, NY, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Schupf', 'Affiliation': ""Mailman School of Public Health, The Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Irving Medical Center, New York, NY, USA.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Burke Neurological Institute, White Plains, NY, USA.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Stern', 'Affiliation': ""Departments of Neurology, Psychiatry, GH Sergievsky Center, the Taub Institute for the Research on Alzheimer's Disease and the Aging Brain, Columbia University Irving Medical Center, New York, NY, USA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Habeck', 'Affiliation': ""Department of Neurology and the Taub Institute for Research on Alzheimer's Disease and the Aging Brain, Columbia University Irving Medical Center, New York, NY, USA.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Jordan', 'Affiliation': 'Rancho Los Amigos National Rehabilitation Center, Downey, CA, USA.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Fonzetti', 'Affiliation': 'Einstein College of Medicine, Bronx NY; Westmed Medical Group White Plains NY.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200896']
1212,33070009,A trial of buspirone for anxiety in Parkinson's disease: Safety and tolerability.,"INTRODUCTION
In Parkinson's disease (PD), anxiety is common, associated with lower health-related quality of life, and undertreated. The primary objective of this study was to determine the tolerability of buspirone for the treatment of anxiety in PD.
METHODS
Individuals with PD and clinically significant anxiety were randomized 4:1 to flexible dosage buspirone or placebo for 12 weeks. Treatment was initiated at 7.5 mg twice daily and titrated based on response and tolerability to an optimal dosage (maximum 30 mg twice daily). The primary outcome was the proportion of participants who failed to complete the study on study drug. Secondary outcomes included adverse events, dosage reductions, motor function, dyskinesias, and anxiety.
RESULTS
A total of 21 participants enrolled, 4 were randomized to placebo and 17 to buspirone (mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic). In the buspirone group, 7 (41%) failed to complete the study on drug, 5 due to intolerability. The median buspirone dosage was 7.5 mg twice daily. No serious adverse events occurred. A total of 9 (53%) buspirone participants experienced adverse events consistent with worsened motor function. In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
CONCLUSION
Tolerability concerns do not support moving immediately forward with a large-scale efficacy trial. However, concomitant anxiolytics may have affected tolerability and a signal of efficacy was seen suggesting that future studies of buspirone monotherapy be considered.",2020,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[""Parkinson's disease"", 'Individuals with PD and clinically significant anxiety', 'mean (SD) age 65.5 (9.8), 76.5% male, 88% on concomitant antidepressant or anxiolytic', 'A total of 21 participants enrolled, 4 were randomized to']","['flexible dosage buspirone or placebo', 'placebo', 'buspirone']","['Parkinson Anxiety Scale', 'adverse events', 'tolerability', 'Hamilton Anxiety Rating Scale', 'adverse events, dosage reductions, motor function, dyskinesias, and anxiety']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]",21.0,0.0671081,"In the buspirone group, mean (SD) improvement from baseline to week 12 in Hamilton Anxiety Rating Scale was -3.9 (3.8) and Parkinson Anxiety Scale -7.1 (6.4).
","[{'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: ruth_schneider@urmc.rochester.edu.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Auinger', 'Affiliation': 'Center for Health and Technology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box 694, Rochester, NY, USA. Electronic address: peggy.auinger@chet.rochester.edu.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Tarolli', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 265 Crittenden Blvd, Box MIND, Rochester, NY, 14642, USA. Electronic address: christopher_tarolli@urmc.rochester.edu.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Iourinets', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: jiourine@u.rochester.edu.'}, {'ForeName': 'María Cristina', 'Initials': 'MC', 'LastName': 'Gil-Díaz', 'Affiliation': 'Department of Neuroscience, University of Rochester, 500 Joseph C. Wilson Blvd, Rochester, NY, 14627, USA. Electronic address: mgildiaz@u.rochester.edu.'}, {'ForeName': 'Irene H', 'Initials': 'IH', 'LastName': 'Richard', 'Affiliation': 'Department of Neurology, University of Rochester School of Medicine and Dentistry, 919 Westfall Rd, Building C, Suite 100, Rochester, NY, 14618, USA. Electronic address: irene_richard@urmc.rochester.edu.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.020']
1213,33070045,Effects of a light therapy intervention on diurnal salivary cortisol in fatigued cancer survivors: A secondary analysis of a randomized controlled trial.,"OBJECTIVE
Altered diurnal cortisol rhythms are a potential mechanism through which symptoms of fatigue are maintained in post-treatment cancer survivors. Exposure to early morning bright light may target this underlying dysregulation, resulting in improved diurnal cortisol patterns, subsequently improving symptoms of fatigue. This research investigates the effects of a 4-week light therapy intervention on the diurnal cortisol slopes and output in fatigued cancer survivors.
METHODS
Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue were randomly assigned to receive either a bright white light (BWL) or dim red light (DRL) device, used daily for 30 min over four consecutive weeks. Assessments of fatigue and salivary cortisol were collected at baseline and post-intervention. Cortisol was sampled four times per day (waking, noon, 5 pm, bedtime) for three days at each timepoint. Diurnal cortisol slopes and total cortisol output were calculated at baseline and post-intervention. Linear mixed models were used to analyze the data.
RESULTS
Seventy-seven participants were included in this analysis (BWL n = 40; DRL n = 37). Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01, Cohen's d = 0.57) and increased total cortisol output (B = 9.58, p = .03, Cohen's d = 0.49) from baseline to post-intervention, indicating only a moderate effect of time. Neither diurnal cortisol slopes nor total cortisol output mediated the relationship between the light therapy intervention and fatigue levels.
CONCLUSION
Though the results of this trial are promising for light therapy as an effective intervention to reduce fatigue in cancer survivors, this does not appear to be achieved through alterations in neuroendocrine function. ClinicalTrials.gov registration #: NCT01780623.",2020,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","['Seventy-seven participants', 'cancer survivors', 'Post-treatment adult cancer survivors who met diagnostic criteria for cancer-related fatigue', 'fatigued cancer survivors']","['light therapy intervention', 'bright white light (BWL) or dim red light (DRL) device']","['diurnal cortisol slopes nor total cortisol output', 'Diurnal cortisol slopes and total cortisol output', 'total cortisol output', 'steepness in cortisol slope', 'fatigue and salivary cortisol', 'diurnal salivary cortisol', 'diurnal cortisol slopes']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0563228', 'cui_str': 'White light'}, {'cui': 'C0114346', 'cui_str': 'dimesna'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",77.0,0.241495,"Participants in both groups displayed increased steepness in cortisol slope (B = -0.02, p = .01,","[{'ForeName': 'Jillian A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, State College, PA, USA. Electronic address: jaj53@psu.edu.'}, {'ForeName': 'Utkarsh', 'Initials': 'U', 'LastName': 'Subnis', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: utkarsh.subnis@ucalgary.ca.'}, {'ForeName': 'Linda E', 'Initials': 'LE', 'LastName': 'Carlson', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: lcarlso@ucalgary.ca.'}, {'ForeName': 'Sheila N', 'Initials': 'SN', 'LastName': 'Garland', 'Affiliation': ""Departments of Psychology and Oncology, Memorial University, St. John's, Newfoundland, Canada. Electronic address: sheila.garland@mun.ca.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Santos-Iglesias', 'Affiliation': 'Department of Psychology, Cape Breton University, Sydney, NS, Canada. Electronic address: pablo_santos@cbu.ca.'}, {'ForeName': 'Katherine-Ann L', 'Initials': 'KL', 'LastName': 'Piedalue', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: klpiedal@ucalgary.ca.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Deleemans', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Division of Medical Science, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada. Electronic address: julie.deleemans@ucalgary.ca.'}, {'ForeName': 'Tavis S', 'Initials': 'TS', 'LastName': 'Campbell', 'Affiliation': 'Department of Oncology and Division of Psychosocial Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Psychology, University of Calgary, Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110266']
1214,33070053,"Combination of gefitinib and olaparib versus gefitinib alone in EGFR mutant non-small-cell lung cancer (NSCLC): A multicenter, randomized phase II study (GOAL).","OBJECTIVES
Progression-free survival (PFS) and response rate to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) varies in patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations, suggesting that other genetic alterations may influence oncogene addiction. Low BRCA1 mRNA levels correlate with longer PFS in erlotinib-treated EGFR-mutant NSCLC patients. Since the poly (ADP-ribose) polymerase (PARP) inhibitor, olaparib, may attenuate and/or prevent BRCA1 expression, the addition of olaparib to gefitinib could improve outcome in EGFR-mutant advanced NSCLC.
MATERIALS AND METHODS
GOAL was a multicenter, randomized phase IB/II study performed in two countries, Spain and Mexico. Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease. Patients were randomly allocated (1:1) to receive gefitinib 250 mg daily or gefitinib 250 mg daily plus olaparib 200 mg three times daily in 28-day cycles. The primary endpoint was PFS. Secondary endpoints included overall survival (OS), response rate, safety and tolerability.
RESULTS
Between September 2013, and July 2016, 182 patients underwent randomization, 91 received gefitinib and 91 received gefitinib plus olaparib. There were no differences in gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation. Median PFS was 10.9 months (95 % CI 9.3-13.3) in the gefitinib arm and 12.8 months (95 % CI 9.1-14.7) in the gefitinib plus olaparib arm (HR 1.38, 95 % CI 1.00-1.92; p = 0.124). The most common adverse events were anemia, 78 % in gefitinib plus olaparib group, 38 % in gefitinib arm, diarrhea, 65 % and 60 %, and fatigue, 40 % and 32 %, respectively.
CONCLUSIONS
The gefitinib plus olaparib combination did not provide significant benefit over gefitinib alone. The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.",2020,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","['182 patients underwent randomization, 91 received', 'Between September 2013, and July 2016', 'patients with non-small-cell lung cancer (NSCLC) driven byEGFR mutations', 'two countries, Spain and Mexico', 'EGFR mutant non-small-cell lung cancer (NSCLC', 'Eligible patients were 18 years or older, treatment-naïve, pathologically confirmed stage IV NSCLC, with centrally confirmed EGFR mutations and measurable disease']","['gefitinib 250\u202fmg daily or gefitinib 250\u202fmg daily plus olaparib 200\u202fmg three times daily in 28-day cycles', 'epidermal growth factor receptor', 'EGFR) tyrosine kinase inhibitors (TKIs', 'gefitinib', 'gefitinib plus olaparib', 'gefitinib and olaparib versus gefitinib alone']","['diarrhea', 'Median PFS', 'hematological and gastrointestinal toxicity', 'PFS', 'overall survival (OS), response rate, safety and tolerability', 'gender, age, smoking status, performance status, presence of bone and brain metastases or type ofEGFR mutation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1176914', 'cui_str': 'gefitinib 250 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]",182.0,0.184564,"The combination's safety profile showed an increase in hematological and gastrointestinal toxicity, compared to gefitinib alone, however, no relevant adverse events were noted.","[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Garcia-Campelo', 'Affiliation': 'University Hospital A Coruña (XXIAC-SERGAS), A Coruña, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Arrieta', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Bartomeu', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Alicante University Hospital, Alicante, Spain.'}, {'ForeName': 'Delvys', 'Initials': 'D', 'LastName': 'Rodriguez-Abreu', 'Affiliation': 'Hospital Universitario Insular De Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ana Laura Ortega', 'Initials': 'ALO', 'LastName': 'Granados', 'Affiliation': 'Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Majem', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Lianes', 'Affiliation': 'Hospital de Mataró, Mataró, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bosch-Barrera', 'Affiliation': 'Catalan Institute of Oncology (ICO) and Girona Biomedical Research Institute (IDIBGi), Girona, Spain.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Insa', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Dómine', 'Affiliation': 'Hospital Universitario Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Reguart', 'Affiliation': ""Hospital Clínic Barcelona, Barcelona, Spain; Translational Genomics and Targeted Therapeutics in Solid Tumors, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Guirado', 'Affiliation': 'Hospital General de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Sala', 'Affiliation': 'Hospital Universitario de Basurto, Bilbao, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Vázquez-Estevez', 'Affiliation': 'Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Reyes Bernabé', 'Initials': 'RB', 'LastName': 'Caro', 'Affiliation': 'Hospital Virgen Del Rocio, Sevilla, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Drozdowskyj', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Verdú', 'Affiliation': 'Spanish Lung Cancer Group Office, Barcelona, Spain.'}, {'ForeName': 'Niki', 'Initials': 'N', 'LastName': 'Karachaliou', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Molina-Vila', 'Affiliation': 'Laboratory of Oncology/Pangaea Oncology, Quiron Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Germans Trias i Pujol Research Institute and Hospital (IGTP), Badalona, Spain. Electronic address: rrosell@iconcologia.net.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.018']
1215,33070057,Salivary measurement and mindfulness-based modulation of prescription opioid cue-reactivity.,"BACKGROUND
Chronic pain patients on long-term opioid therapy (LTOT) may be at elevated risk for developing conditioned opioid cue-reactivity as their prescribed dosing schedules simultaneously function as fixed reinforcement schedules. Since opioids are typically consumed orally during LTOT, it stands to reason that opioid cue exposure might elicit conditioned salivary responses. However, no study has examined salivary cue-reactivity among opioid users during in-vivo exposure to their own prescription opioid medication.
METHODS
Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics. Study 1 aimed to determine whether chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid. Study 2 was a pilot study that aimed to assess the effects of behavioral treatment on chronic pain patients' salivary cue-reactivity.
RESULTS
In Study 1, exposure to the patient's own prescribed opioid resulted in significantly greater increases in salivation and cue-elicited craving than exposure to a neutral cue. In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
CONCLUSIONS
Study findings demonstrate salivation may serve as a useful, objective index of opioid cue-reactivity. With further refinement of this task, conditioned salivary response could be used to identify especially vulnerable patients, who then could be targeted with a personalized medicine approach for selective and intensive prevention/treatment interventions to preempt escalation of opioid use to opioid misuse and OUD.",2020,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","['chronic pain patients receiving LTOT exhibited salivary cue-reactivity to their prescribed opioid', 'Chronic pain patients on long-term', ""chronic pain patients' salivary cue-reactivity"", 'Two samples (N = 68, N = 39) of chronic pain patients on LTOT were recruited from primary care and specialty care clinics']","['8-week Mindfulness-Oriented Recovery Enhancement intervention', 'behavioral treatment', 'opioid therapy (LTOT']","['salivation and cue-elicited craving', 'opioid cue-reactivity', 'salivation and craving ratings']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0036104', 'cui_str': 'Salivary secretion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",2.0,0.0378235,"In Study 2 participants who were randomized to an 8-week Mindfulness-Oriented Recovery Enhancement intervention evidenced significantly greater decreases in opioid cue-reactivity than participants in an active control condition as evidenced by both reduced salivation and craving ratings.
","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Hanley', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Garland', 'Affiliation': 'Center on Mindfulness and Integrative Health Intervention Development, University of Utah, United States; College of Social Work, University of Utah, United States; Salt Lake City Veterans Administration Medical Center, United States. Electronic address: eric.garland@socwk.utah.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108351']
1216,33075332,A randomized controlled trial of methylergonovine prophylaxis after dilation and evacuation abortion.,"OBJECTIVE
To evaluate the efficacy of intramuscular methylergonovine maleate as prophylaxis against excessive bleeding when given after dilation and evacuation (D&E) at 20-24 weeks.
STUDY DESIGN
We performed a randomized, double-blinded, placebo-controlled trial in patients without excessive bleeding requiring intervention after D&E completion. We administered study treatment within one minute of the end of the procedure. We primarily compared outcomes using a composite of indicators of excessive post-procedure blood loss (post-procedure measured blood loss exceeding 125 mL, uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery). Secondary outcomes included individual indicator occurrences, satisfaction, and side effects.
RESULTS
From March 3, 2015 to March 31, 2017, we randomized 284 participants (n = 140 methylergonovine, n = 144 placebo), five before we registered the trial with clinicaltrials.gov. Baseline characteristics were similar between groups. The composite outcome occurred in 78 (56%) methylergonovine and 75 (52%) placebo participants (p = 0.5). Methylergonovine recipients required more intrauterine balloon use (n = 20 [14%]) versus placebo (n = 10 [7%]), p = 0.04. We also observed a non-significant trend towards more uterotonic administration (n = 56 [40%] versus n = 43 [30%], p = 0.07) and hospital admissions for bleeding (n = 4 [3%] versus n = 0, p = 0.06) in the methylergonovine group compared to placebo.
CONCLUSION
We observed no improvement in the composite outcome for excessive bleeding with prophylactic post-procedure methylergonovine. In addition, individual excessive bleeding outcomes occurred more frequently in the methylergonovine group, potentially indicating harm with its prophylactic use after D&E.
IMPLICATIONS
When administered prophylactically immediately after dilation and evacuation abortion at 20-24 weeks, methylergonovine increases uterine bleeding. Given the lack of data for effectiveness as a prophylactic agent and our findings indicating harm, we do not recommend its use for post-operative prophylaxis.",2020,"Methylergonovine recipients required more intrauterine balloon use (n=20 [14%]) versus placebo (n=10 [7%]), p=0.04.","['284 participants (n=140', 'patients without excessive bleeding requiring intervention after D&E completion']","['methylergonovine', 'uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery', 'methylergonovine maleate', 'methylergonovine prophylaxis', 'placebo', 'methylergonovine, n=144 placebo', 'Methylergonovine']","['individual indicator occurrences, satisfaction, and side effects', 'hospital admissions for bleeding', 'intrauterine balloon use', 'individual excessive bleeding outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0025760', 'cui_str': 'Methylergonovine'}, {'cui': 'C0404386', 'cui_str': 'Uterine massage'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3653843', 'cui_str': 'UTEROTONICS'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0289432', 'cui_str': 'Methylergonovine maleate'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",284.0,0.773533,"Methylergonovine recipients required more intrauterine balloon use (n=20 [14%]) versus placebo (n=10 [7%]), p=0.04.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kerns', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States. Electronic address: Jennifer.kerns@ucsf.edu.'}, {'ForeName': 'Geffan', 'Initials': 'G', 'LastName': 'Pearlson', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States.'}, {'ForeName': 'Biftu', 'Initials': 'B', 'LastName': 'Mengesha', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Harter', 'Affiliation': 'University of California, San Francisco, School of Pharmacy; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Jackson', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States.'}, {'ForeName': 'Eleanor A', 'Initials': 'EA', 'LastName': 'Drey', 'Affiliation': 'University of California, San Francisco, Department of Obstetrics, Gynecology and Reproductive Sciences; Zuckerberg San Francisco General, 1001 Potrero Avenue, Ward 6D, San Francisco, CA 94110, United States.'}]",Contraception,['10.1016/j.contraception.2020.10.009']
1217,33085033,"Pharmacokinetics and Pharmacodynamics of JNJ-55920839, an Antibody Targeting Interferon α/ω, in Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus.","BACKGROUND
The interferon (IFN) pathway has been correlated with clinical and serological markers of disease activity in patients with systemic lupus erythematosus (SLE).
OBJECTIVE
The pharmacokinetics and pharmacodynamics of JNJ-55920839, a fully human immunoglobulin G1κ antibody targeting IFNα/ω, were investigated.
METHODS
In a double-blind, first-in-human study, Part A enrolled 48 healthy adults who received a single dose of placebo/JNJ-55920839 between 0.3 and 15 mg/kg intravenous (IV) or at 1 mg/kg subcutaneous (SC). Part B enrolled 26 adults with SLE who received placebo or JNJ-55920839 10 mg/kg IV 6 times biweekly. Pharmacokinetic parameters were calculated by noncompartmental analysis (NCA) and estimated by nonlinear mixed-effects modeling.
RESULTS
JNJ-55920839 pharmacokinetics following a single IV infusion exhibited a biphasic disposition in healthy subjects. Maximum plasma concentration (C max ) and area under the concentration-time curve values increased dose-proportionally. Mean clearance (CL) after a single IV infusion ranged between 2.28 and 3.09 mL/kg/day. Absolute bioavailability after a single SC injection was ≥ 80.0%. Mean terminal elimination half-life (t 1/2 ) was similar after IV (20.7 to 24.6 days) and SC administration (22.6 days). Steady state of JNJ-55920839 was achieved 6 weeks after multiple 10 mg/kg IV doses in subjects with SLE. Mean steady-state CL and t 1/2 were 4.73 mL/kg/day and 14.8 days, respectively. A linear 2-compartment population pharmacokinetic model with 1st-order absorption and elimination adequately characterized the pharmacokinetics; parameters were consistent with NCA estimates. Higher CL was estimated in subjects with SLE compared with healthy subjects, after correcting for body weight. A trend of increased total IFNα/ω levels was observed after treatment with JNJ-55920839.
CONCLUSION
Pharmacokinetic and pharmacodynamic analyses of the data from this study demonstrated that there was biphasic disposition in both healthy subjects and subjects with SLE, CL was faster in subjects with SLE, and increases in total IFNα/ω levels were observed in both healthy subjects and subjects with SLE after treatment with JNJ-55920839, thus further development is supported. The study is registered at ClinicalTrials.gov NCT02609789.",2020,Maximum plasma concentration (C max ) and area under the concentration-time curve values increased dose-proportionally.,"['patients with systemic lupus erythematosus (SLE', 'Part\xa0B enrolled 26\xa0adults with SLE who received', 'healthy subjects', 'Healthy Subjects and Subjects with Mild-to-Moderate Systemic Lupus Erythematosus', '48 healthy adults who received a single dose of']","['placebo or JNJ-55920839', 'placebo/JNJ-55920839 between 0.3 and 15\xa0mg/kg intravenous (IV) or at 1\xa0mg/kg subcutaneous\xa0(SC']","['Maximum plasma concentration (C max ) and area under the concentration-time curve values', 'Mean steady-state CL', 'biphasic disposition', 'Pharmacokinetic parameters', 'Higher CL', 'total IFNα/ω levels', 'Mean terminal elimination half-life', 'Mean clearance (CL', 'Absolute bioavailability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205184', 'cui_str': 'Biphasic'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",48.0,0.142169,Maximum plasma concentration (C max ) and area under the concentration-time curve values increased dose-proportionally.,"[{'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Loggia', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Chevrier', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Marciniak', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Janssen Research and Development, LLC, Clin Pharm TA PA, SH32-10590, Welsh & McKean Road, Spring House, PA, 19477, USA. ZXu5@its.jnj.com.'}]",Clinical drug investigation,['10.1007/s40261-020-00978-4']
1218,33085056,"Role of GLP-1 Receptor Agonists in Pediatric Obesity: Benefits, Risks, and Approaches to Patient Selection.","PURPOSE OF REVIEW
Effective treatments for pediatric obesity are limited. Glucagon-like peptide-1 receptor (GLP-1R) agonists have emerged as therapeutic agents for obesity in adults and have shown benefits outside of weight loss. Here we explore the evidence for GLP-1R agonist use in pediatric obesity.
RECENT FINDINGS
Emerging evidence suggests that GLP-1R agonists have a role in pediatric obesity treatment. A recently published, randomized, placebo-controlled trial found a greater reduction in BMI z-score (- 0.22 SDs) in adolescents receiving liraglutide compared with placebo. As in adults, gastrointestinal adverse effects were commonly seen. GLP-1R agonists appear to perform favorably compared with other approved pharmacological agents for pediatric obesity. However, heterogeneity in weight loss response, cost, side effects, and need for injections may limit their use in many pediatric patients. Rather than broadly applying this therapy if it is approved, we suggest careful patient selection and monitoring by clinicians pending further studies.",2020,Glucagon-like peptide-1 receptor (GLP-1R) agonists have emerged as therapeutic agents for obesity in adults and have shown benefits outside of weight loss.,"['adolescents receiving', 'Pediatric Obesity']","['liraglutide', 'placebo', 'GLP-1 Receptor Agonists', 'Glucagon-like peptide-1 receptor (GLP-1R) agonists']","['BMI z-score', 'weight loss response, cost, side effects', 'gastrointestinal adverse effects']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.059442,Glucagon-like peptide-1 receptor (GLP-1R) agonists have emerged as therapeutic agents for obesity in adults and have shown benefits outside of weight loss.,"[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Page', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Duke University Medical Center, 3000 Erwin Road, Suite 200, Durham, NC, 27705, USA. laura.page@duke.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Freemark', 'Affiliation': 'Division of Pediatric Endocrinology and Diabetes, Duke University Medical Center, 3000 Erwin Road, Suite 200, Durham, NC, 27705, USA.'}]",Current obesity reports,['10.1007/s13679-020-00409-7']
1219,33080122,"Walking in multiple sclerosis improves with tDCS: a randomized, double-blind, sham-controlled study.","OBJECTIVE
To evaluate whether multiple sessions of transcranial direct current stimulation (tDCS) applied to the primary motor (M1) cortex paired with aerobic exercise can improve walking functions in multiple sclerosis (MS).
METHODS
MS participants were recruited for a double-blind, parallel-arm, randomized, sham-controlled trial and assigned to 10 sessions (5 d/wk for 2 weeks) of either active or sham tDCS paired with unloaded cycling for 20 minutes. Stimulation was administered over the left M1 cortex (2.5 mA; anode over C3/cathode over FP2). Gait spatiotemporal parameters were assessed using a wearable inertial sensor (10-meter and 2-minute walking tests). Measurements were collected at baseline, end of tDCS intervention, and 4-week postintervention to test for duration of any benefits.
RESULTS
A total of 15 participants completed the study, nine in the active and six in the sham condition. The active and sham groups were matched according to gender (50% vs. 40% female), neurologic disability (median EDSS 5.5 vs. 5), and age (mean 52.1 ± 12.9 vs. 53.7 ± 9.8 years). The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline. At 4-week follow-up, these improvements were maintained (baseline vs. follow-up: gait speed 0.87 vs. 1.18 m/s, p < 0.001; distance traveled 118.53 vs. 143.82 m, p < 0.001).
INTERPRETATION
Multiple sessions of tDCS paired with aerobic exercise lead to cumulative and persisting improvements in walking and endurance in patients with MS.",2020,"The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline.","['multiple sclerosis (MS', '15 participants completed the study, nine in the active and six in the sham condition', 'median EDSS 5.5 vs. 5), and age (mean 52.1\xa0±\xa012.9 vs. 53.7\xa0±\xa09.8\xa0years', 'patients with MS', 'MS participants']","['transcranial direct current stimulation (tDCS', 'tDCS', 'aerobic exercise', 'active or sham tDCS paired with unloaded cycling for 20\xa0minutes']","['walking functions', 'neurologic disability', 'Gait spatiotemporal parameters', 'duration of any benefits', 'gait speed']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",15.0,0.418567,"The active group had a significantly greater increase in gait speed (0.87 vs. 1.20 m/s, p < 0.001) and distance covered during the 2-minute walking test (118.53 vs. 133.06 m, p < 0.001) at intervention end compared to baseline.","[{'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Pilloni', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Department of Medicine, SUNY Downstate, New York, NY, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, Binghamton University, New York, NY, USA.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Coghe', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Krupp', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Moffat', 'Affiliation': 'Department of Physical Therapy, New York University, New York, NY, USA.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cocco', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pau', 'Affiliation': 'Department of Mechanical, Chemical and Materials Engineering, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Charvet', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51224']
1220,33086156,Model and approach for assessing implementation context and fidelity in the HEALing Communities Study.,"BACKGROUND
In response to the U.S. opioid epidemic, the HEALing (Helping to End Addiction Long-term SM ) Communities Study (HCS) is a multisite, wait-listed, community-level cluster-randomized trial that aims to test the novel Communities That HEAL (CTH) intervention, in 67 communities. CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths. We present the rationale for and adaptation of the RE-AIM/PRISM framework and methodological approach used to capture the CTH implementation context and to evaluate implementation fidelity.
METHODS
HCS measures key domains of the internal and external CTH implementation context with repeated annual surveys and qualitative interviews with community coalition members and key stakeholders. Core constructs of fidelity include dosage, adherence, quality, and program differentiation-the adaptation of the CTH intervention to fit each community's needs. Fidelity measures include a monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes. Training and technical assistance delivered by the research sites to the communities are tracked monthly.
DISCUSSION
To help attenuate the nation's opioid epidemic, the adoption of EBPs must be increased in communities. The HCS represents one of the largest and most complex implementation research experiments yet conducted. Our systematic examination of implementation context and fidelity will significantly advance understanding of how to best evaluate community-level implementation of EBPs and assess relations among implementation context, fidelity, and intervention impact.",2020,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.",[],"['CTH intervention', 'HEAL (CTH) intervention', 'CTH']","['monthly CTH checklist, collation of artifacts produced during CTH activities, coalition and workgroup attendance, and coalition meeting minutes']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0247065,"CTH will expand an integrated set of evidence-based practices (EBPs) across health care, behavioral health, justice, and other community-based settings to reduce opioid overdose deaths.","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'Knudsen', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky, 845 Angliana Avenue, Room 204, Lexington, KY, 40508, USA. Electronic address: hannah.knudsen@uky.edu.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Section of Infectious Diseases and Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2014, Boston, MA, 02118, USA. Electronic address: drainoni@bu.edu.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Gilbert', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: lg123@columbia.edu.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Huerta', 'Affiliation': 'College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: timothy.huerta@osumc.edu.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Oser', 'Affiliation': 'Department of Sociology and Center on Drug and Alcohol Research, University of Kentucky, 1531 Patterson Office Tower, Lexington, KY, 40506, USA. Electronic address: carrie.oser@uky.edu.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Aldrich', 'Affiliation': 'CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: alison.aldrich@osumc.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Drive, Box 120, New York, NY, 10032, USA. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Erika L', 'Initials': 'EL', 'LastName': 'Crable', 'Affiliation': 'Evans Center for Implementation and Improvement Sciences, Department of Medicine, Boston University School of Medicine, Department of Health Law, Policy and Management, Boston University School of Public Health, 801 Massachusetts Avenue, Room 2030, Boston, MA, 02118, USA. Electronic address: ecrable@bu.edu.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: bgarner@rti.org.'}, {'ForeName': 'LaShawn M', 'Initials': 'LM', 'LastName': 'Glasgow', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: lglasgow@rti.org.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Goddard-Eckrich', 'Affiliation': 'Social Intervention Group, Columbia University School of Social Work, 1255 Amsterdam Avenue, New York, NY, 10027, USA. Electronic address: dg2121@columbia.edu.'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Marks', 'Affiliation': 'Department of Behavioral Science, University of Kentucky, 1100 Veterans Drive, Medical Behavioral Science Building Room 108, Lexington, KY, 40536, USA. Electronic address: katie.marks@uky.edu.'}, {'ForeName': 'Ann Scheck', 'Initials': 'AS', 'LastName': 'McAlearney', 'Affiliation': 'Department of Family and Community Medicine and CATALYST, the Center for the Advancement of Team Science, Analytics, and Systems Thinking in Health Services and Implementation Science Research, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 530, Columbus, OH, 43210, USA. Electronic address: ann.mcalearney@osumc.edu.'}, {'ForeName': 'Emmanuel A', 'Initials': 'EA', 'LastName': 'Oga', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, Research Triangle Park, NC, 27709-2194, USA. Electronic address: eoga@rti.org.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Scalise', 'Affiliation': 'Department of Infectious Disease, Boston Medical Center, 801 Massachusetts Avenue, Boston, MA, 02118, USA. Electronic address: ariel.scalise@bmc.org.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Walker', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine, The Ohio State University, 460 Medical Center Drive, Suite 520, Columbus, OH, 43210, USA. Electronic address: daniel.walker@osumc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108330']
1221,32687741,Age- and Weight-Adapted Dose of Prasugrel Versus Standard Dose of Ticagrelor in Patients With Acute Coronary Syndromes : Results From a Randomized Trial.,"BACKGROUND
The efficacy and safety of a reduced dose of prasugrel versus a standard dose of ticagrelor in elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS) are unknown.
OBJECTIVE
To investigate the effect of an age- and weight-adapted dose of prasugrel versus a standard dose of ticagrelor in patients with ACS. (ClinicalTrials.gov: NCT01944800).
DESIGN
Prespecified analysis of the multicenter, randomized ISAR-REACT 5 trial.
SETTING
23 centers in Germany and Italy.
PATIENTS
3997 patients with ACS planned for invasive management.
INTERVENTION
Participants were randomly assigned to receive a standard dose of ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group).
MEASUREMENTS
The efficacy end point was a composite of death, myocardial infarction, or stroke, and the safety end point was bleeding, both at 12 months.
RESULTS
In the elderly or low-weight group, the efficacy end point occurred in 12.7% of patients assigned to receive prasugrel and 14.6% of those assigned to receive ticagrelor (hazard ratio [HR], 0.82 [95% CI, 0.60 to 1.14]); in the neither elderly nor low-weight group, the efficacy end point occurred in 4.8% of patients assigned to receive prasugrel and 7.3% of those assigned to receive ticagrelor (HR, 0.65 [CI, 0.48 to 0.88]; P for interaction > 0.2). In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; P for interaction > 0.2).
LIMITATION
The study is a subgroup analysis.
CONCLUSION
In elderly or low-weight patients with ACS, a reduced dose of prasugrel compared with the standard dose of ticagrelor is associated with maintained anti-ischemic efficacy while protecting these patients against the excess risk for bleeding.
PRIMARY FUNDING SOURCE
German Center for Cardiovascular Research and Deutsches Herzzentrum München.",2020,"In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; P for interaction > 0.2).
","['23 centers in Germany and Italy', 'Patients With Acute Coronary Syndromes', 'elderly patients or those with a low body weight presenting with an acute coronary syndrome (ACS', 'patients with ACS', '3997 patients with ACS planned for invasive management', 'In elderly or low-weight patients with ACS']","['Prasugrel Versus Standard Dose of Ticagrelor', 'prasugrel', 'ticagrelor or prasugrel (reduced dose in the elderly or low-weight group and standard dose in the neither elderly nor low-weight group', 'ticagrelor']","['efficacy end point', 'composite of death, myocardial infarction, or stroke, and the safety end point was bleeding']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",3997.0,0.113308,"In the elderly or low-weight group, Bleeding Academic Research Consortium type 3 to 5 bleeding occurred in 8.1% of patients assigned to receive prasugrel and 10.6% of those assigned to receive ticagrelor (HR, 0.72 [0.46 to 1.12]), and in 3.7% and 3.8%, respectively, of patients in the neither elderly nor low-weight group (HR, 0.98 [CI, 0.65 to 1.47]; P for interaction > 0.2).
","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Menichelli', 'Affiliation': 'Ospedale Fabrizio Spaziani, Cardiology, Frosinone, Italy (M.M.).'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany (F.N., D.T.).'}, {'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Wöhrle', 'Affiliation': 'Medical Campus Lake Constance, Friedrichshafen, Germany (J.W.).'}, {'ForeName': 'Isabell', 'Initials': 'I', 'LastName': 'Bernlochner', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I (Kardiologie, Angiologie, Pneumologie), Klinikum rechts der Isar, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (I.B.).'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Heart Center Bad Segeberg, Bad Segeberg, Germany (G.R.).'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Witzenbichler', 'Affiliation': 'Helios Amper-Klinikum Dachau, Dachau, Germany (B.W.).'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Sibbing', 'Affiliation': 'Klinik der Universität München, Ludwig-Maximilians-Universität, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (D.S.).'}, {'ForeName': 'Senta', 'Initials': 'S', 'LastName': 'Gewalt', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine, Jacksonville, Florida (D.J.A.).'}, {'ForeName': 'Shqipdona', 'Initials': 'S', 'LastName': 'Lahu', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany (G.N., K.M., S.G., S.L.).'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Heart Center, Campus Kerckhoff of Justus-Liebig-University, Giessen, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Rhine-Main, Germany (C.W.H.).'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hapfelmeier', 'Affiliation': 'Technical University of Munich, School of Medicine, Institute of Medical Informatics, Statistics and Epidemiology, Munich, Germany (A.H.).'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Trenk', 'Affiliation': 'University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany (F.N., D.T.).'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Laugwitz', 'Affiliation': 'Medizinische Klinik und Poliklinik Innere Medizin I, Klinikum rechts der Isar, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (K.L.).'}, {'ForeName': 'Heribert', 'Initials': 'H', 'LastName': 'Schunkert', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (H.S., S.S., A.K.).'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schüpke', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (H.S., S.S., A.K.).'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München and Technische Universität München, Munich, Germany, and German Center for Cardiovascular Research (DZHK), Partner Site Munich Heart Alliance, Germany (H.S., S.S., A.K.).'}]",Annals of internal medicine,['10.7326/M20-1806']
1222,32675432,Combining neurofeedback with source estimation: Evaluation of an sLORETA neurofeedback protocol for chronic tinnitus treatment.,"BACKGROUND
Alpha/delta neurofeedback has been shown to be a potential treatment option for chronic subjective tinnitus. Traditional neurofeedback approaches working with a handful of surface electrodes have been criticized, however, due to their low spatial specificity.
OBJECTIVE
The purpose of this study was to evaluate an innovative tomographic neurofeedback protocol that combines neural activity measured across the whole scalp with sLORETA source estimation.
METHODS
Forty-eight tinnitus patients participated in 15 neurofeedback training sessions as well as extensive pre, post, and follow-up testing. Patients were randomly assigned to either a tomographic (TONF) or a traditional electrode-based neurofeedback (NTNF) group. Main outcome measures of this study were defined as tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and resting-state EEG activity in trained frequency bands.
RESULTS
For both groups a significant reduction of tinnitus-related distress and tinnitus loudness was found. While distress changes remained persistent irrespective of group, loudness levels returned to baseline in the follow-up period. No significant between-group differences between the 2 neurofeedback applications (TONF vs. NTNF) were found, which suggests a similar contribution to symptom improvement. The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period. This effect was found irrespective of group on both surface and source levels with no meaningful differences between the 2 groups.
CONCLUSIONS
Our study shows that a tomographic alpha/delta protocol should be considered a promising addition to tinnitus treatment but that more individually specific neurofeedback protocols should be developed.",2020,The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period.,"['chronic tinnitus treatment', 'Forty-eight tinnitus patients participated in 15']","['neurofeedback training sessions', 'tomographic (TONF) or a traditional electrode-based neurofeedback (NTNF']","['tinnitus-related distress and tinnitus loudness', 'trained alpha/delta ratio', 'tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and resting-state EEG activity in trained frequency bands', 'loudness levels']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0178733', 'cui_str': 'Loudness'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",48.0,0.0426258,The trained alpha/delta ratio increased significantly over the course of the training and remained stable in the follow-up period.,"[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Güntensperger', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kleinjung', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neff', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thüring', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Meyer', 'Affiliation': 'Division of Neuropsychology, Department of Psychology, University of Zurich, Zurich, Switzerland.'}]",Restorative neurology and neuroscience,['10.3233/RNN-200992']
1223,32674103,Lost in Transition: Is Early Respiratory Support in Newborn Infants the Best Option?,"BACKGROUND
Late preterm and term newborns with respiratory distress are increasingly treated with non-invasive ventilation (NIV) including nasal high-flow or continuous positive airway pressure. For infants with mild distress, NIV may be unnecessary.
OBJECTIVES
We speculated that treatment with supplemental oxygen (SO) prior to NIV could help clinicians select infants for NIV treatment, and examined this hypothesis using data from a recently completed trial.
METHOD
Post hoc analysis of data from a subset of infants enrolled in the HUNTER trial. Infants born at ≥36 weeks' gestation were categorized by whether they were receiving SO prior to randomization. The 2 groups were compared for illness severity (indicated by treatment failure at 72 h, mechanical ventilation, need for up-transfer, SO requirement post-randomization, and length of time receiving respiratory support), use of selected medical interventions (antibiotics, intravenous fluids), and breastfeeding at discharge.
RESULTS
Analysis included 380 infants. Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%). Most infants in both groups received intravenous fluids (93 and 98%) and antibiotics (81 and 93%); the rate of full breastfeeding was low in both groups (51 and 45%).
CONCLUSIONS
Late preterm and term newborn infants without SO requirement at the time of commencing NIV for respiratory distress are at lower risk of requiring treatment escalation. Close observation of these infants (watch and wait strategy) may avoid unnecessary treatment.",2020,"Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%).","[""Infants born at ≥36 weeks' gestation"", 'Late preterm and term newborns with respiratory distress', 'Post hoc analysis of data from a subset of infants enrolled in the HUNTER trial', '380 infants', 'Newborn Infants']",['supplemental oxygen (SO'],"['severe illness; lower rates of treatment failure', 'rate of full breastfeeding', 'mechanical ventilation']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319693', 'cui_str': '380'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",380.0,0.196799,"Infants not receiving SO had less severe illness; lower rates of treatment failure (7.3 vs. 17.2%), mechanical ventilation (0.6 vs. 5.9%), need for transfer (6.8 vs. 13.8%), and more often did not receive any SO post-randomization (75.1 vs. 3.0%).","[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Buckmaster', 'Affiliation': 'Women, Children and Families, Central Coast Local Health District, Gosford, New South Wales, Australia, agbuck@ozemail.com.au.'}, {'ForeName': 'Gaston', 'Initials': 'G', 'LastName': 'Arnolda', 'Affiliation': 'Australian Institute for Healthcare Innovation, Macquarie University, North Ryde, New South Wales, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': ""Monash Newborn, Monash Children's Hospital, Clayton, Victoria, Australia.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Manley', 'Affiliation': ""Newborn Research Centre and Neonatal Services, The Royal Women's Hospital, Parkville, Victoria, Australia.""}]",Neonatology,['10.1159/000508554']
1224,33080208,Comparing the Effects of Tongue-In-Groove and Septocolumellar Suture With Short and Floating Columellar Strut of Open Rhinoplasty on Nasal Tip Rotation and Projection.,"PURPOSE
In rhinoplasty, it is important to maintain the desired tip projection and rotation. The aim of the present study was to compare the tongue-in-groove (TIG) method and the septocolumellar suture method with short and floating columellar strut methods over a six-month follow-up period.
METHODS
A total of 69 patients were evaluated. The TIG method was used on 39 patients (group 1, TIG group), and the remaining 30 patients received septocolumellar suture supported with short and floating columellar strut (group 2, suture + graft group). Standardized right profile images were taken preoperatively and 6 months after the operations. Goode's method and nasofacial angle were used to evaluate nasal tip projection, and the nasolabial angle was measured to evaluate tip rotation. The outcomes of the 2 surgical approaches were compared, and P values lower than 0.05 were considered significant.
RESULTS
Although nasal tip rotation in the postoperative sixth month was higher than that in the preoperative period in both groups (TIG: 96.8° vs 108.2° and suture + graft: 100.8° vs 104.2°, respectively), this change was significant only in the TIG group (P < .001). Goode's ratio increased significantly in both groups compared with the postoperative period (TIG: 0.62 vs 0.57 and suture + graft: 0.62 vs 0.58; P < .001 and .047, respectively). On the other hand, nasofacial angle decreased significantly in both groups compared with the postoperative period (TIG: 147.8° vs 144.0° and suture + graft: 149.1° vs 146.3°; P < .001).
CONCLUSIONS
As per the results of the present study, both studied methods can be safely used in nasal tip surgery. Compared with the septocolumellar suture + columellar strut method, the TIG method resulted in a higher rotation increase. Both methods led to significant increases in projection, and these increases did not differ between the groups.",2020,"Goode's ratio increased significantly in both groups compared with the postoperative period (TIG: 0.62 vs 0.57 and suture + graft: 0.62 vs 0.58; P < .001 and .047, respectively).",['A total of 69 patients were evaluated'],"['septocolumellar suture method with short and floating columellar strut methods', 'suture\xa0+\xa0graft', 'Tongue-In-Groove and Septocolumellar Suture With Short and Floating Columellar Strut of Open Rhinoplasty', 'septocolumellar suture supported with short and floating columellar strut (group 2, suture\xa0+\xa0graft group']","['nasofacial angle', ""Goode's ratio""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0396086', 'cui_str': 'Open rhinoplasty'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",69.0,0.021764,"Goode's ratio increased significantly in both groups compared with the postoperative period (TIG: 0.62 vs 0.57 and suture + graft: 0.62 vs 0.58; P < .001 and .047, respectively).","[{'ForeName': 'Ceyhun', 'Initials': 'C', 'LastName': 'Aksakal', 'Affiliation': 'Associate Professor, Department of Otorhinolaryngology, Gaziosmanpaşa University Medical School, Tokat, Turkey. Electronic address: aksakalceyhun@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.09.030']
1225,33080291,Effects of nicotine on pupil size and performance during multiple-object tracking in non-nicotine users.,"Nicotine has been commonly used in pyschopharmacological studies, showing its benefits as a pharmacological stimulant on cognitive performance. In the current study, we investigated the effects of 2 mg (Experiment 1) and 4 mg (Experiment 2) of nicotine on performance on a multiple-object-tracking task. Participants were young non-smoking adults with no pre-existing attentional deficits. Nicotine and placebo were administered through nicotine and nicotine-free taste-matched chewing gum, respectively. Additionally, we compared pupil size between nicotine and placebo conditions in both experiments. Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance. We speculate that nicotine might enhance performance only for certain cognitive functions, and only for specific populations, such as nicotine-deprived smokers.",2020,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","['Participants were young non-smoking adults with no pre-existing attentional deficits', 'non-nicotine users']","['nicotine', 'Nicotine', 'nicotine and nicotine-free taste-matched chewing gum', 'Nicotine and placebo']","['behavioural performance', 'pupil size and performance during multiple-object tracking', 'pupil size']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C4302494', 'cui_str': 'Nicotine user'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]",,0.0190549,"Although we found that pupil size was considerably smaller in the nicotine conditions, nicotine administration did not appear to facilitate behavioural performance.","[{'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Wardhani', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway; Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands; Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium. Electronic address: intankusuma.wardhani@ugent.be.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mathôt', 'Affiliation': 'Department of Experimental Psychology, University of Groningen, Grote Kruisstraat 2/1, 9712 TS Groningen, the Netherlands.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Boehler', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Henri Dunantlaan 2, 9000 Ghent, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Laeng', 'Affiliation': 'Department of Psychology, University of Oslo, Forskningsveien 3A, 0373 Oslo, Norway.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.09.005']
1226,33080294,The effects of an internet-based mindfulness meditation intervention on electrophysiological markers of attention.,"Evidence suggests that mindfulness meditation training has the potential to train aspects of attention. However, the neurophysiological mechanisms underpinning the attentional benefits from mindfulness remain unclear. This randomized controlled trial examined changes in electrophysiological markers of attention before and after completion of a 6-week internet-based mindfulness intervention. EEG and ERP data were collected from 64 generally healthy, mildly stressed older adults. Participants were randomized to an internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a waitlist control condition. Attentional N2 and P3 evoked potentials were derived from active and passive auditory oddball paradigms. Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls. There were no significant relationships between the intervention and N2 potentials. Our data demonstrate a measurable increase in attentional control when discriminating or directing attention away from auditory stimuli for older adult participants who received mindfulness training. These findings lend support to the use of the P3 as a neurophysiological measure of meditation engagement and intervention efficacy.",2020,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"['64 generally healthy, mildly stressed older adults']","['internet-based mindfulness meditation intervention', 'mindfulness meditation training', 'internet-based mindfulness-based stress reduction course (IMMI), an internet-based health and wellness education course, or a wait list control condition', '6-week internet-based mindfulness intervention']","['attentional control', 'P3 peak-trough amplitude', 'Attentional N2 and P3 evoked potentials']","[{'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]",64.0,0.0204774,Participants in the IMMI group showed significantly greater differences in P3 peak-trough amplitude between the active and passive oddball paradigms at endpoint relative to controls.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Klee', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America. Electronic address: klee@ohsu.edu.'}, {'ForeName': 'Dana Dharmakaya', 'Initials': 'DD', 'LastName': 'Colgan', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'National University of Natural Medicine, United States of America.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Oken', 'Affiliation': 'Oregon Health & Science University, Department of Neurology, United States of America; Oregon Health & Science University, Departments of Behavioral Neuroscience and Biomedical Engineering, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.002']
1227,33080376,Comparison of adverse events between cervical disc arthroplasty and anterior cervical discectomy and fusion: a 10-year follow-up.,"BACKGROUND CONTEXT
Cervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported.
PURPOSE
To investigate the 10-year follow-up adverse events rates between CDA and ACDF.
STUDY DESIGN/SETTING
The study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a postapproval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004.
PATIENT SAMPLE
n=463 patients.
OUTCOME MEASURES
Adverse events comparison of CDA and ACDF from self-reported and physiologic measures.
METHODS
At each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups.
RESULTS
A total of 242 patients received CDA and 221 patients received ACDF. At 10-year follow-up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p=0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p=.012) and more spinal events at the index level (p=.006). The ACDF group had significantly more nonunion events (p=.019), and nonunion outcome pending (p=.034), adjacent level spinal events (p=.033), and events that fell into the ""other"" category (p=.015).
CONCLUSIONS
The cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.",2020,"However, there were more adverse events in the CDA group resulting from trauma (p = 0.012) and more spinal events at the index level (p = 0.006).","['SAMPLE\n\n\nn=463 patients', 'Cervical Disc Arthroplasty and Anterior Cervical Discectomy and Fusion', '242 patients received CDA and 221 patients received']","['CDA', 'Cervical disc arthroplasty (CDA', 'ACDF']","['adjacent level spinal events', '10-year cumulative rates', 'spinal events', 'cumulative rate of all adverse events', 'Adverse events', 'adverse events', 'cumulative rates', 'non-union events', 'cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, urogenital and intraoperative vascular injury']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}]","[{'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C4552558', 'cui_str': 'Implant malposition'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0178324', 'cui_str': 'Injury of blood vessel'}]",242.0,0.0632128,"However, there were more adverse events in the CDA group resulting from trauma (p = 0.012) and more spinal events at the index level (p = 0.006).","[{'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Loidolt', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, 750 E. Adams St, Syracuse, NY 13210 USA.'}, {'ForeName': 'Swamy', 'Initials': 'S', 'LastName': 'Kurra', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, 750 E. Adams St, Syracuse, NY 13210 USA.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': 'Riew', 'Affiliation': 'Columbia University Medical Center, 51 W. 51st St, #370, New York, NY 10019 USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Levi', 'Affiliation': 'Department of Neurological Surgery, University of Miami, Miller School of Medicine, 1095 NW 14th Terrace, Miami, FL 33136 USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Florman', 'Affiliation': 'Neurological Surgery, Maine Medical Center, 49 Spring St Scarborough, ME 04074 USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Lavelle', 'Affiliation': 'Department of Orthopedic Surgery, SUNY Upstate Medical University, 750 E. Adams St, Syracuse, NY 13210 USA. Electronic address: lavellew@upstate.edu.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.10.013']
1228,32672062,An Ex Vivo Study to Evaluate the Effect of Tegaserod on Platelet Activation and Aggregation.,"INTRODUCTION
Tegaserod, an orally active, potent 5-hydroxytryptamine-4 serotonin receptor agonist, was previously indicated for irritable bowel syndrome but was voluntarily withdrawn due to potential cardiovascular side effects. In vitro studies suggested that tegaserod increased platelet aggregation, but these results were not reproduced or were inconclusive. We sought to assess ex vivo effects of tegaserod on platelet aggregation.
METHODS
In this double-blind, placebo-controlled, crossover study, we randomized a majority of healthy patients with no history of cardiovascular risk factors (n = 21) to receive tegaserod or matching placebo for 7 + 2 days followed by a 7- to 10-day washout period, and then patients were crossed over to the other study drug for the next 7 + 2 days. Unstimulated and agonist-stimulated platelet aggregation; P-selectin expression; serum thromboxane (Tx)B 2 and urinary 11-dehydro (11-dh) TxB 2 ; and tegaserod and M29.0 concentrations were serially assessed.
RESULTS
There was no significant difference in percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression in the presence of tegaserod at any time point when compared to placebo. Similarly, there was no significant difference in percentage change in serum TxB 2 or urinary 11-dhTxB 2 levels between placebo and tegaserod. No new or unexpected findings were observed in evaluations of safety or pharmacokinetic parameters.
CONCLUSION
This comprehensive pharmacodynamic study, by employing established markers used in prior investigations, which have been considered by the Food and Drug Administration to indicate drug-related platelet effects, does not demonstrate any influence of tegaserod treatment on platelet function.",2021,"There was no significant difference in percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression in the presence of tegaserod at any time point when compared to placebo.",['healthy patients with no history of cardiovascular risk factors (n = 21'],"['tegaserod', 'tegaserod or matching placebo', 'placebo', 'Tegaserod']","['platelet aggregation', 'percentage change in serum TxB 2 or urinary 11-dhTxB 2 levels', 'percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression', 'Platelet Activation and Aggregation', 'thromboxane (Tx)B 2 and urinary 11-dehydro (11-dh) TxB 2 ; and tegaserod and M29.0 concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0537147', 'cui_str': 'tegaserod'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0252816', 'cui_str': 'thrombin receptor peptide SFLLRNP'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032173', 'cui_str': 'Platelet activation'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0040061', 'cui_str': 'Thromboxane'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C0537147', 'cui_str': 'tegaserod'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0890886,"There was no significant difference in percentage change in unstimulated or adenosine diphosphate (ADP)- and ADP + serotonin-, collagen- and thrombin receptor activating peptide-induced maximum platelet aggregation and in platelet P-selectin expression in the presence of tegaserod at any time point when compared to placebo.","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Sinai Center for Thrombosis Research, 23303Sinai Hospital of Baltimore, LifeBridge Health, Baltimore, MD, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bliden', 'Affiliation': 'Sinai Center for Thrombosis Research, 23303Sinai Hospital of Baltimore, LifeBridge Health, Baltimore, MD, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Barnett', 'Affiliation': 'Inova Center for Thrombosis Research and Drug Development, 237248Inova Heart and Vascular Institute, Fairfax, VA, USA.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Witt', 'Affiliation': '483275US WorldMeds LLC, Louisville, KY, USA.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zou', 'Affiliation': '483275US WorldMeds LLC, Louisville, KY, USA.'}, {'ForeName': 'Udaya', 'Initials': 'U', 'LastName': 'Tantry', 'Affiliation': 'Sinai Center for Thrombosis Research, 23303Sinai Hospital of Baltimore, LifeBridge Health, Baltimore, MD, USA.'}]",Journal of cardiovascular pharmacology and therapeutics,['10.1177/1074248420942004']
1229,32674587,Effects of exercise modality on body composition and cardiovascular disease risk factors in adolescents with obesity: a randomized clinical trial.,"We compared the effects of aerobic exercise, resistance exercise, and combined aerobic and resistance exercise on total, regional subcutaneous adipose tissue (SAT) and visceral AT (VAT), skeletal muscle (SM), and biomarkers of cardiovascular disease in adolescents. Adolescents with overweight/obesity ( N = 118; body mass index ≥ 85th percentile; age, 12-17 years) were randomized to 1 of the following groups for 6 months (3 days/week, 180 min/week): aerobic exercise ( n = 38), resistance exercise ( n = 40), or combined aerobic and resistance exercise ( n = 40). After accounting for age, sex, and baseline value, there was a greater ( P < 0.05) reduction in body weight in the aerobic exercise group compared with the resistance exercise group and the combined groups. There were reductions ( P < 0.05) in total and regional SAT within the aerobic exercise group only, and the reductions in lower-body SAT were greater ( P = 0.02) than the combined group. All groups had reductions ( P < 0.01) in VAT, with no group differences. There were significant increases in total and regional SM mass in the resistance exercise and combined group, and not in the aerobic exercise group. Although all exercise modalities are effective in reducing VAT, aerobic exercise is superior at reducing total and regional SAT, but inferior for increasing SM in adolescents with obesity. Despite reductions in VAT, carotid-femoral pulse wave velocity and carotid intima-media thickness did not improve with either exercise. Clinicaltrials.gov identifier: NCT01938950. Novelty Regular exercise (180 min/week) is associated with reductions in visceral fat independent of exercise modality. Resistance exercise alone and combined resistance and aerobic exercise are similarly effective in increasing SM mass.",2020,"There were significant increases in total and regional SM mass in the RE and combined group, and not in the AE group.","['118 adolescents with overweight/obesity (BMI>85th percentile, 12-17 years', 'adolescents with obesity', 'adolescents']","['exercise modality', 'aerobic exercise (AE), resistance exercise (RE) and combined AE and RE', 'RE (n=40) or combined AE and RE', '∙Resistance exercise alone and combined resistance and aerobic exercise']","['lower-body SAT', 'VAT, carotid-femoral pulse wave velocity and carotid intima-media thickness', 'body weight', 'total and regional SM mass', 'body composition and cardiovascular disease risk factors', 'total, regional subcutaneous adipose tissue (SAT) and visceral AT (VAT), skeletal muscle (SM) and biomarkers of cardiovascular disease (CVD']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.061567,"There were significant increases in total and regional SM mass in the RE and combined group, and not in the AE group.","[{'ForeName': 'SoJung', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Sports Medicine, Graduate School of Physical Education, Kyung Hee University, Yongin 17104, Republic of Korea.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Libman', 'Affiliation': ""Division of Pediatric Endocrinology, Metabolism and Diabetes Mellitus, UPMC Children's Hospital of Pittsburgh, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15224, USA.""}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Hughan', 'Affiliation': ""Division of Pediatric Endocrinology, Metabolism and Diabetes Mellitus, UPMC Children's Hospital of Pittsburgh, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15224, USA.""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kuk', 'Affiliation': 'School of Kinesiology and Health Science, York University, Toronto, ON M3J 1P3, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Barinas-Mitchell', 'Affiliation': 'Department of Epidemiology Ultrasound Research Laboratory, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA 15224, USA.'}, {'ForeName': 'Hyeok', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Physical Education, Kyung Hee University, Yongin 17104, Republic of Korea.'}, {'ForeName': 'Silva', 'Initials': 'S', 'LastName': 'Arslanian', 'Affiliation': ""Division of Pediatric Endocrinology, Metabolism and Diabetes Mellitus, UPMC Children's Hospital of Pittsburgh, School of Medicine, University of Pittsburgh, Pittsburgh, PA 15224, USA.""}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0993']
1230,33066865,Tai Chi training for attention deficit hyperactivity disorder: A feasibility trial in college students.,"OBJECTIVE
Many young adults are affected by attention deficit hyperactivity disorder (ADHD) and often desire non-pharmacological treatment options. Mind-body techniques might serve as complementary therapies to first-line stimulant medications, but studies are limited. Tai Chi is an increasingly popular practice that integrates movement with cognitive skills relevant to ADHD. We performed a feasibility trial of Tai Chi training in undergraduates to inform the design of a fully powered randomized controlled trial (RCT).
METHOD
Undergraduates with ADHD were recruited, screened, enrolled, and assessed at baseline. They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments. Feasibility of a larger clinical trial was evaluated, especially with respect to enrollment and retention. Additionally, potential clinical outcome measures were examined for practicality and reliability.
RESULTS
21 participants were assessed at baseline and 19 at follow-up (90 % retention). The primary clinical outcome measure, self-reported inattention symptoms (Conners' CAARS-S:L DSM-IV Inattentive Symptoms subscale), exhibited good test-retest reliability in controls (r = 0.87, n = 10) and correlated with reduced mindfulness (FFMQ acting with awareness subscale) at baseline (r = -0.74, n = 20). Class attendance and self-reported daily practice time were variable. Randomization to group classes was hindered by the college students' restricted schedules.
CONCLUSION
The high retention rate and good data quality suggest that an RCT of Tai Chi for ADHD is feasible. Further measures are identified to improve enrollment rates, adherence, and randomization procedures. Future work might extend to other young adult populations and high school students.",2020,"They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments.","['college students', 'attention deficit hyperactivity disorder', 'young adults', 'young adult populations and high school students', 'Undergraduates with ADHD were recruited, screened, enrolled, and assessed at baseline']","['Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments', 'Tai Chi training']","[""self-reported inattention symptoms (Conners' CAARS-S:L DSM-IV Inattentive Symptoms subscale), exhibited good test-retest reliability"", 'Class attendance and self-reported daily practice time', 'practicality and reliability', 'reduced mindfulness (FFMQ acting with awareness subscale']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",21.0,0.0515994,"They were assigned to three parallel seven-week intervention arms, Tai Chi, Active Control (cardio-aerobic fitness), and Inactive Control (no contact), with follow-up assessments.","[{'ForeName': 'Alexander K', 'Initials': 'AK', 'LastName': 'Converse', 'Affiliation': 'Waisman Center, University of Wisconsin-Madison, United States. Electronic address: akconverse@wisc.edu.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Barrett', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States.'}, {'ForeName': 'Betty A', 'Initials': 'BA', 'LastName': 'Chewning', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, United States.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Harvard Medical School and Brigham and Women's Hospital, United States.""}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102538']
1231,33069121,Add-on memantine may improve cognitive functions and attenuate inflammation in middle- to old-aged bipolar II disorder patients.,"OBJECTIVES
Chronic inflammation and neuroprogression underlie bipolar disorder (BP) and associated cognitive deficits. Memantine (MM) exerts neuroprotective effects by reducing neuroinflammation. Therefore, we investigated whether add-on low-dose MM (5 mg/day) in BP-II patients may improve cognition and inflammation.
METHODS
We combined two 12-week randomized, double-blind, placebo-controlled studies (NCT01188148 and NCT03039842) for analysis. Each participant was allocated to the MM or placebo group. Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1 (TGF-β1), and brain-derived neurotrophic factor (BDNF)] were evaluated at baseline and endpoint. A subgroup analysis of middle- to old-aged BP-II patients was also performed.
RESULTS
We recruited 155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group. Add-on MM did not result in significant improvements in cognitive functions in all BP-II patients, but a group difference in TNF-α levels was found in the MM group (P=0.04). Specifically, in middle- to old-aged BP-II patients, there was a significant time and group interaction effect on omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs) in the MM group (P=0.007, 0.02, and 0.01, respectively), and a decrease in plasma TNF-α levels (P=0.04).
LIMITATIONS
The sample size of middle- to old-aged BP-II patients were limited.
CONCLUSION
Add-on MM may attenuate inflammation in BP-II and improve cognition in middle- to old-aged BP-II patients.",2020,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","['155 BP-II patients (23 of which were middle- to old-aged) for the MM group and 170 patients (20 of which were middle- to old-aged) for the placebo group', 'sample size of middle- to old-aged BP-II patients were limited', 'middle- to old-aged bipolar II disorder patients']","['MM or placebo', 'placebo', 'Memantine (MM', 'memantine']","['TGF-β1), and brain-derived neurotrophic factor (BDNF', 'omission T-scores, hit reaction time T-scores, and hit reaction time standard error T-scores on continuous performance tests (CPTs', 'TNF-α levels', 'cognition and inflammation', 'cognitive functions', 'plasma TNF-α levels', 'Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1']","[{'cui': 'C0236788', 'cui_str': 'Bipolar II disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}]",,0.407349,"Symptom severity, neuropsychological tests, and the cytokine plasma levels [tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), interleukin-8 (IL-8), transforming growth factor-β1","[{'ForeName': 'Ru-Band', 'Initials': 'RB', 'LastName': 'Lu', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Yanjiao Furen Hospital, Hebei, China.'}, {'ForeName': 'Tzu-Yun', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. Electronic address: wangty@mail.ncku.edu.tw.'}, {'ForeName': 'Sheng-Yu', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Yun-Hsuan', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychology, Asia University, Taichung, Taiwan; Department of Medical Research, China Medical University Hospital, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Shiou-Lan', 'Initials': 'SL', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan; Lipid Science and Aging Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yu', 'Initials': 'TY', 'LastName': 'Tsai', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Po See', 'Initials': 'PS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'San-Yuan', 'Initials': 'SY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Student Counseling Center, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'I Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kao Chin', 'Initials': 'KC', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yen Kuang', 'Initials': 'YK', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Institute of Behavioral Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Department of Psychiatry, Tainan Hospital, Ministry of Health and Welfare, Tainan, Taiwan.'}, {'ForeName': 'Jau-Shyong', 'Initials': 'JS', 'LastName': 'Hong', 'Affiliation': 'Neurobiology Laboratory, NIH/NIEHS, Research Triangle Park, NC, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.003']
1232,33074110,Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked-down due to COVID-19 online randomized study.,"AIM
to compare anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE). Methods- Participants were assessed for BHT and RPE, before training on any one intervention using online platforms, for one week during lockdown from COVID-19.15 participants in each group total N = 60 at- (α - 0.05), (1- β - 0.90) & (effect size - 0.55); were analysed. Results - AVP & DBE decreased RPE (p < 0.000). KBP & PLB did not decrease RPE as compared to AVP & DBE (p. > 0.05). DBE increased BHT more than KBP & PLB interventions (p < 0.05), but not more than AVP (p > 0.05). One-way ANOVA of four interventions revealed significant variation for RPE change (p < 0.05), for AVP. Conclusions - AVP reduces RPE maximally during breath-holding, whereas DPE increases BHT more.",2020,KBP & PLB did not decrease RPE as compared to AVP & DBE,['60\xa0at'],"['Breathing exercises and pranayamas to decrease perceived exertion during breath-holding while locked', 'AVP & DBE']","['RPE', 'anulom vilom pranayama (AVP), kapal bhati pranayama (KBP), diaphragmatic breathing exercises (DBE), and pursed-lip breathing (PLB) for breath holding time (BHT) and rating of perceived exertion (RPE', 'RPE change', 'DBE increased BHT']",[],"[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}, {'cui': 'C0425465', 'cui_str': 'Pursed-lip breathing'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0686435,KBP & PLB did not decrease RPE as compared to AVP & DBE,"[{'ForeName': 'Mayank', 'Initials': 'M', 'LastName': 'Shukla', 'Affiliation': 'AP-III, AIPT, 9711113097, India. Electronic address: mailmayankshukla@gmail.com.'}, {'ForeName': 'Diksha', 'Initials': 'D', 'LastName': 'Chauhan', 'Affiliation': 'BPT Interns, AIPT, India.'}, {'ForeName': 'Ritu', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'BPT Interns, AIPT, India.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101248']
1233,33074143,Ketamine Alters Electrophysiological Responses to Emotional Faces in Major Depressive Disorder.,"BACKGROUND
The glutamatergic modulator ketamine rapidly reduces depressive symptoms in individuals with treatment-resistant major depressive disorder (MDD). However, ketamine's effects on emotional processing biases remain largely unknown, and understanding these processes may help elucidate ketamine's mechanism of action.
METHODS
Magnetoencephalography (MEG) was used to investigate ketamine's effects on early visual responses to affective stimuli in individuals with MDD (n=31) and healthy volunteers (HVs; n=24). Participants were enrolled in a double-blind, placebo-controlled, crossover clinical trial and were assessed at baseline and after subanesthetic-dose ketamine and placebo-saline infusions. During MEG recording, participants completed an emotional evaluation task in which they indicated the sex or emotional valence (happy-neutral or sad-angry) of facial stimuli. Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies were extracted from regions of interest. Linear fixed effects models examined interactions between diagnosis, stimulus valence, and drug session for behavioral and MEG data.
RESULTS
In baseline behavioral analyses, MDD participants exhibited higher accuracy for sad-angry than happy-neutral faces, and HVs responded faster to happy-neutral than sad-angry faces. In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine. Finally, fusiform M170 amplitudes were associated with antidepressant response in MDD participants.
LIMITATIONS
The modest sample size and the need to collapse across responses to happy and neutral faces to increase statistical power limit the generalizability of the findings.
CONCLUSIONS
Ketamine rapidly altered emotional stimulus processing in MDD, laying the groundwork for future investigations of biomarkers of antidepressant treatment response.
CLINICAL TRIAL
Clinicaltrials.gov, NCT#00088699.",2020,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","['individuals with MDD (n=31) and healthy volunteers (HVs; n=24', 'Major Depressive Disorder', 'individuals with treatment-resistant major depressive disorder (MDD']","[""ketamine's"", 'Ketamine', 'glutamatergic modulator ketamine', 'ketamine', 'Magnetoencephalography (MEG', 'ketamine and placebo-saline infusions', 'placebo']","['Source-localized event-related field (ERF) M100 and M170 amplitudes and latencies', 'sex or emotional valence (happy-neutral or sad-angry) of facial stimuli', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.464333,"In the MEG post-infusion analyses, calcarine M100 amplitudes were larger in MDD than HV participants post-placebo but became more similar post-ketamine.","[{'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Lundin', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA.'}, {'ForeName': 'Linnea', 'Initials': 'L', 'LastName': 'Sepe-Forrest', 'Affiliation': 'Department of Psychological and Brain Sciences and Program in Neuroscience, Indiana University, Bloomington, IN, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Frederick W', 'Initials': 'FW', 'LastName': 'Carver', 'Affiliation': 'Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Furey', 'Affiliation': 'Janssen Pharmaceuticals of Johnson and Johnson Inc., San Diego, CA, United States.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA;; Magnetoencephalography Core Facility, National Institute of Mental Health, Bethesda, MD, USA;. Electronic address: nugenta@mail.nih.gov.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.007']
1234,33071206,Mitigating the effects of COVID-19 pandemic on controlling vascular risk factors among participants in a carotid stenosis trial.,"INTRODUCTION
The COVID-19 pandemic has presented challenges to managing vascular risk factors with in-person follow-up of patients with asymptomatic carotid stenosis enrolled in the CREST2 trial. CREST2 is comparing intensive medical management alone versus intensive medical management plus revascularization with endarterectomy or stenting. We performed a study to evaluate the feasibility of a home-based program for testing blood pressure (BP) and low-density lipoprotein (LDL) in CREST2.
METHODS
This study involved 45 patients at 10 sites in the CREST2 trial. The initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL > 90 mg/dl, or both. If a patient at the site declined participation, another was substituted. All patients who agreed to participate were sent a BP monitoring device and a commercially available at-home lipid test kit that uses a self-performed finger-stick blood sample that was resulted to the patient. Training on the use of the equipment and obtaining the risk factor results was done by the study coordinator by telephone.
RESULTS
Ten of the 130 currently active CREST2 sites participated, 8 in the LDL portion and 5 in the BP portion (3 sites did both). Twenty-six BP devices and 23 lipid tests were sent to patients. Of the 26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3. Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
CONCLUSION
This study established the feasibility of at-home monitoring of BP and LDL in a clinical trial and identified implementation challenges prior to widespread use in the trial. (ClinicalTrials.gov number NCT02089217).",2020,"Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
","['23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4', 'participants in a carotid stenosis trial', 'patients with asymptomatic carotid stenosis enrolled in the CREST2 trial', '45 patients at 10 sites in the CREST2 trial', 'initial patients were identified by the Medical Management Core (MMC) as high-risk patients defined by stage 2 hypertension, LDL ', '26 patients who obtained BP readings with the devices, 9 were out of the study target and adjustments in BP medications were made in 3']","['COVID-19 pandemic', 'CREST2']",['testing blood pressure (BP) and low-density lipoprotein (LDL'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0007282', 'cui_str': 'Carotid artery stenosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}]",45.0,0.0283477,"Of the 23 patients sent LDL tests, 13 were able to perform the test showing 7 were out of target, leading to adjustments in lipid medications in 4.
","[{'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Neurology, Medical University of South Carolina (MUSC), 96 Jonathan Lucas Street, MSC 606, Charleston 29425, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Meschia', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Roldan', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'LeMatty', 'Affiliation': 'Neurology, MUSC, Charleston, SC, United States.'}, {'ForeName': 'Sothear', 'Initials': 'S', 'LastName': 'Luke', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Breathitt', 'Affiliation': 'Neurology, Baptist Health Lexington, Lexington, KY, United States.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Eiland', 'Affiliation': 'Cardiovascular Associates, Brookwood Baptist Health, Birmingham, AL, United States.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Foley', 'Affiliation': 'Neurology, Oregon Health and Science University, Portland, OR, United States.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Brott', 'Affiliation': 'Neurology, Mayo Clinic, Jacksonville, FL, United States.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105362']
1235,33075592,Quantifying regional variations in components of acute stroke unit (ASU) care in the international HeadPoST study.,"OBJECTIVE
Access to acute stroke unit (ASU) care is known to vary worldwide. We aimed to quantify regional variations in the various components of ASU care.
METHOD
Secondary analysis of the Head Positioning in acute Stroke Trial (HeadPoST), an international, multicentre, cluster crossover trial of head-up versus head-down positioning in 11,093 acute stroke patients at 114 hospitals in 9 countries. Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America [Brazil/Chile/Colombia]). Variations in process of ASU care estimates were obtained in hierarchical mixed models, with adjustment for study design and potential patient- and hospital-level confounders.
RESULTS
Of 11,086 patients included in analyses, 59.7% (n = 6620) had an ASU admission. In China, India/Sri Lanka and South America, ASU patients were older, had greater neurological severity and more premorbid conditions than non-ASU patients. ASU patients were more likely to receive reperfusion therapy and multidisciplinary care within regions, but the components of care varied across regions. With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
CONCLUSION
There is significant variation in the components of stroke care across economically-defined regions of the world. Ongoing efforts are required to reduce disparities and optimise health outcomes, especially in resource poor areas.
CLINICAL TRIAL REGISTRATION
HeadPoST is registered at ClinicalTrials.gov (NCT02162017).",2020,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","['Patients characteristics and 11 standard components of processes of care were described according to ASU admission within and across four economically-defined regional groups (Australia/UK, China [includes Taiwan], India/Sri Lanka, and South America', 'Secondary analysis of the Head Positioning in acute Stroke Trial ', '11,093 acute stroke patients at 114 hospitals in 9 countries', 'Of 11,086 patients included in analyses, 59.7% (n\xa0=\xa06620) had an ASU admission']","['HeadPoST', 'head-up versus head-down positioning']",['probability of receiving reperfusion therapy'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0582540', 'cui_str': 'Head position finding'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]",,0.177773,"With Australia/UK as reference, patients in other regions had a lower probability of receiving reperfusion therapy, especially in India/Sri Lanka (adjusted odds ratio [aOR] 0.27, 95% confidence interval [CI] 0.12-0.63) and multidisciplinary care (mainly in formal dysphagia assessment, physiotherapy and occupational therapy).
","[{'ForeName': 'Menglu', 'Initials': 'M', 'LastName': 'Ouyang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, Shenyang First People's Hospital, Shenyang, China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Billot', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Pablo M', 'Initials': 'PM', 'LastName': 'Lavados', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Verónica V', 'Initials': 'VV', 'LastName': 'Olavarría', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Muñoz-Venturelli', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute, St Vincent's Health Network Sydney, St Vincent's Hospital, Melbourne and Australian Catholic University, Sydney, Australia.""}, {'ForeName': 'Caroline L', 'Initials': 'CL', 'LastName': 'Watkins', 'Affiliation': 'Faculty of Health and Wellbeing, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Octavio M', 'Initials': 'OM', 'LastName': 'Pontes-Neto', 'Affiliation': 'Stroke Service - Neurology Division, Department of Neuroscience and Behavioral Sciences, Ribeirão Preto Medical School, University of Sao Paulo, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Tsong-Hai', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Stroke Center and Department of Neurology, Linkou Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Alejandro M', 'Initials': 'AM', 'LastName': 'Brunser', 'Affiliation': 'Unidad de Neurología Vascular, Servicio de Neurología, Departmento de Neurologia y Psiquiatria, Clínica Alemana de Santiago, Facultad de Medicina, Clínica Alemana, Universidad del Desarrollo, Chile.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia; The George Institute China at Peking University Health Science Center, Beijing, China; Centro de Estudios Clínicos, Instituto de Ciencias e Innovación en Medicina, Facultad de Medicina Clínica Alemana Universidad del Desarrollo, Santiago, Chile; Neurology Department, Royal Prince Alfred Hospital, Sydney Health Partners, Sydney, Australia; Heart Health Research Center, Beijing, China. Electronic address: canderson@georgeinstitute.org.au.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117187']
1236,33082033,"Corrigendum to ""Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON)"" [Respir. Med. 170 (Aug-Sep 2020) 106021].",,2020,,"['170', 'patients with uncontrolled asthma']","['indacaterol/glycopyrronium/mometasone furoate', 'salmeterol/fluticasone twice-daily plus tiotropium']",[],"[{'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]",[],,0.307449,,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany. Electronic address: studien@pois-le.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kornmann', 'Affiliation': 'IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Salina', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pritam', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bostel', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Lorena Garcia', 'Initials': 'LG', 'LastName': 'Conde', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pfister', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106186']
1237,33090368,Neuromagnetic Amygdala Response to Pain-Related Fear as a Brain Signature of Fibromyalgia.,"INTRODUCTION
Fibromyalgia (FM) is a chronic pain condition characterized by impaired emotional regulation. This study explored the brain response to pain-related fear as a potential brain signature of FM.
METHODS
We used a conditioned fear task and magnetoencephalography to record pain-related fear responses in patients with FM. Two blocks of 30 fear responses were collected to compute the response strength in the first block and the strength difference between the first and second blocks (fear habituation). These measurements were investigated for their clinical relevance and compared with measurements obtained from healthy controls and patients with chronic migraine (CM), a different chronic pain condition often comorbid with FM.
RESULTS
Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups. However, fear habituation in the right amygdala decreased in the FM group (vs. CM and control groups, both p ≤ 0.001, no difference between CM and control groups). At the 3-month follow-up, the patients with FM reporting < 30% improvement in pain severity (n = 15) after pregabalin treatment exhibited lower fear habituation in the left amygdala at baseline (vs. ≥ 30% improvement, n = 22, p = 0.019). Receiver operating characteristic analysis confirmed that amygdala fear habituation is a suitable predictor of diagnosis and treatment outcomes of FM (area under the curve > 0.7).
CONCLUSIONS
Amygdala activation to pain-related fear is maladaptive and linked to treatment outcomes in patients with FM. Because the aberrant amygdala response was not observed in the CM group, this response is a potential brain signature of FM.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier, NCT02747940.",2020,"RESULTS
Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups.","['healthy controls and patients with chronic migraine (CM), a different chronic pain condition often comorbid with FM', 'patients with FM']",['conditioned fear task and magnetoencephalography'],"['fear habituation in the right amygdala', 'response strength', 'fear habituation', 'aberrant amygdala response', 'pain severity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0711474,"RESULTS
Pain-related fear clearly activated the bilateral amygdala and anterior insula in patients with FM (n = 52), patients with CM (n = 50), and the controls (n = 30); the response strength in the first block was consistent across groups.","[{'ForeName': 'Fu-Jung', 'Initials': 'FJ', 'LastName': 'Hsiao', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ta', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan. wtchen@vghtpe.gov.tw.'}, {'ForeName': 'Yu-Chieh', 'Initials': 'YC', 'LastName': 'Ko', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hung-Yu', 'Initials': 'HY', 'LastName': 'Liu', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Feng', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Pin', 'Initials': 'SP', 'LastName': 'Chen', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Kuan-Lin', 'Initials': 'KL', 'LastName': 'Lai', 'Affiliation': 'School of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Department of Allergy, Immunology and Rheumatology, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Coppola', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome Polo Pontino, Latina, Italy.'}, {'ForeName': 'Shuu-Jiun', 'Initials': 'SJ', 'LastName': 'Wang', 'Affiliation': 'Brain Research Center, National Yang-Ming University, Taipei, Taiwan. sjwang@vghtpe.gov.tw.'}]",Pain and therapy,['10.1007/s40122-020-00206-z']
1238,33091844,Operationalizing and selecting outcome measures for the HEALing Communities Study.,"BACKGROUND
The Helping to End Addiction Long-term SM (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes.
METHODS
Priority was given to using administrative data and established data collection infrastructure to ensure reliable, timely, and sustainable measures and to harmonize study outcomes across the HCS sites.
RESULTS
The research teams established multiple data use agreements and developed technical specifications for more than 80 study measures. The primary outcome, number of opioid overdose deaths, will be measured from death certificate data. Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths: (1) number of naloxone units distributed in HCS communities; (2) number of unique HCS residents receiving Food and Drug Administration-approved buprenorphine products for treatment of opioid use disorder; and (3) number of HCS residents with new incidents of high-risk opioid prescribing.
CONCLUSIONS
The HCS has already made an impact on existing data capacity in the four states. In addition to providing data needed to measure study outcomes, the HCS will provide methodology and tools to facilitate data-driven responses to the opioid epidemic, and establish a central repository for community-level longitudinal data to help researchers and public health practitioners study and understand different aspects of the Communities That HEAL framework.",2020,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,[],"['buprenorphine', 'HEAL intervention']","['support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths', 'number of opioid overdose deaths, will be measured from death certificate data']",[],"[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1510541', 'cui_str': 'Evidence-Based Practice'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0011066', 'cui_str': 'Death certificate'}]",,0.102551,Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths:,"[{'ForeName': 'Svetla', 'Initials': 'S', 'LastName': 'Slavova', 'Affiliation': 'Department of Biostatistics, University of Kentucky, Healthy Kentucky Research Building RB2, Suite 260, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: ssslav2@email.uky.edu.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'LaRochelle', 'Affiliation': 'Clinical Addiction Research and Education Unit, Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine and Boston Medical Center, 801 Massachusetts Avenue, 2nd Floor, Boston, MA, 02218, USA. Electronic address: marc.larochelle@bmc.org.'}, {'ForeName': 'Elisabeth D', 'Initials': 'ED', 'LastName': 'Root', 'Affiliation': 'Department of Geography and Division of Epidemiology, The Ohio State University, and Translational Data Analytics Institute Columbus, The Ohio State University, 1036 Derby Hall, 154 N. Oval Mall, Columbus, OH, 43210, USA. Electronic address: root.145@osu.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Room 1059, Miami, FL, 33136, USA. Electronic address: dfeaster@med.miami.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institutes of Health, National Institute on Drug Abuse, 3WFN, MSC 6025, 301 North Stonestreet Avenue, Bethesda, MD, 20892, USA. Electronic address: jennifer.villani@nih.gov.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Knott', 'Affiliation': 'Social, Statistical and Environment Sciences Survey Research Division, RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA. Electronic address: cknott@rti.org.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Talbert', 'Affiliation': 'Division of Biomedical Informatics, University of Kentucky College of Medicine, 267 Healthy Kentucky Research Building, 760 Press Avenue, Lexington, KY, 40536, USA. Electronic address: jeff.talbert@uky.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mack', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Aimee.mack@osumc.edu.'}, {'ForeName': 'Dushka', 'Initials': 'D', 'LastName': 'Crane', 'Affiliation': 'Ohio Colleges of Medicine Government Resource Center, The Ohio State University Wexner Medical Center, 150 Pressey Hall, 1070 Carmack Road, Columbus, OH, 43210, USA. Electronic address: Dushka.crane@osumc.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Bernson', 'Affiliation': 'Massachusetts Department of Public Health, 250 Washington Street, Boston, MA, 02108, USA. Electronic address: Dana.Bernson@mass.gov.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Booth', 'Affiliation': 'Biostatistics and Epidemiology Division, RTI International, 6110 Executive Blvd, Suite 900, Rockville, MD, 20852, USA. Electronic address: abooth@rti.org.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walsh', 'Affiliation': 'Department of Behavioral Science and Center on Drug and Alcohol Research, University of Kentucky College of Medicine, 845 Angliana Avenue, Lexington, KY, 40508, USA. Electronic address: sharon.walsh@uky.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108328']
1239,33096333,Effectiveness of guided internet-based interventions in the indicated prevention of depression in green professions (PROD-A): Results of a pragmatic randomized controlled trial.,"BACKGROUND
Major Depressive Disorder (MDD) has a major impact on public health. Reduction of depression burden in general population is of greatest importance and might be achieved by implementation of depression prevention measures into routine care. We evaluate an online prevention measure as part of a national project aiming to reduce depression in the occupational group of green professions.
METHODS
This two-armed pragmatic RCT (n = 360) evaluates the effectiveness of a tailored internet-based intervention (IMI) program compared to enhanced treatment as usual. The IMI program entailed access to one of six guided IMIs each focusing on different symptom areas (depressive mood with optional comorbid diabetes, perceived stress, insomnia, panic and agoraphobia and harmful alcohol consumption). Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5). Primary outcome was depressive symptom severity (QIDS-SR16) at 9-weeks post-treatment (T1). Various secondary outcomes were assessed at T1.
RESULTS
A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033). Categorical analysis indicated a reduced risk of potential MDD with NNTB=28.11. Adherence to the IMI program at T1 was exceptionally low.
LIMITATIONS
Results are limited to green professions and representativeness might be restricted by self-selection of participants.
CONCLUSION
Depression burden in green professions can be reduced by this online prevention measure. Yet, short-term effectiveness is restricted by low adherence rates.
TRIAL REGISTRATION
German Clinical Trial Registration: DRKS00014000. Registered: 09 April 2018.",2021,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","['green professions (PROD-A', 'Eligible were entrepreneurs, spouses, family members and pensioners in green professions with adequate insurance status and at least subthreshold depression (PHQ≥5', 'Major Depressive Disorder (MDD']","['guided internet-based interventions', 'tailored internet-based intervention (IMI) program']","['stress, insomnia, panic and agoraphobia and harmful alcohol consumption', 'risk of potential MDD', 'depressive symptom severity (QIDS-SR16', 'depression reduction']","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0070319', 'cui_str': 'Cytochrome p450 CYP2B1 enzyme'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.107642,"A small effect of depression reduction (d=-0.28, 95%-CI: -0.50 to -0.07) was found at T1 favouring the IMI program (β=-0.22, 95%-CI: -0.41 to -0.02, p=.033).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Braun', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany. Electronic address: lina.braun@uni-ulm.de.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany; Department of Research Methods, Institute of Psychology and Education, University of Ulm, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Freund', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Janika', 'Initials': 'J', 'LastName': 'Thielecke', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Friedrich-Alexander-University of Erlangen-Nürnberg, Erlangen, Germany; GET.ON Institute, Berlin, Germany; Department of Clinical, Neuro- & Developmental Psychology, VU University Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, University of Ulm, Ulm, Germany.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.066']
1240,33096362,Simulation strategies to increase nursing student clinical competence in safe medication administration practices: A quasi-experimental study.,"BACKGROUND
Nursing student medication errors often result from deficits in knowledge and application of fundamental safe administration practices. Factors such as high faculty-student ratios and legal restrictions have decreased clinical learning opportunities for nursing students to practice safe medication administration in the clinical setting. Evidence suggests that use of a structured medication safety enhancement (MSE) simulation program can significantly improve student knowledge and competency in safe medication administration.
PURPOSE
To examine the effects of an educational strategy using a MSE simulation program with integrated technology on the medication administration knowledge, competency, and confidence levels of undergraduate nursing students.
METHODS
This quasi-experimental replication study designed and implemented medication simulations enhanced by integrated information technologies in an undergraduate-nursing curriculum. Third-year BSN students (n = 83) were randomized into intervention or control groups. Control groups participated in standard training while the intervention group received additional clinical simulation experience and debriefing sessions focused on medication safety practices. Participant knowledge was measured using pre/post Medication Safety Knowledge Assessment (MSKA) and competency was evaluated using the Medication Safety Critical Element Checklist (MSCEC).
RESULTS
The MSKA and MSCEC were analyzed using two-sided independent t-tests. Post-test knowledge scores increased in both groups but results were not statistically significant (α = 0. 05). Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
CONCLUSION
Findings suggest that educators should consider high fidelity simulation as an evidence-based teaching strategy to engage students in understanding and implementing medication safety practices in the clinical setting.",2020,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","['undergraduate-nursing curriculum', 'Third-year BSN students (n\xa0=\xa083', 'undergraduate nursing students']",['standard training while the intervention group received additional clinical simulation experience and debriefing sessions'],"['Post-test knowledge scores', 'Medication Safety Critical Element Checklist (MSCEC']","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1098180', 'cui_str': 'bis((di-n-butyl 3,6-dioxaheptanoato)tin)'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",83.0,0.0131788,"Students who received the medication safetfy enhancement intervention performed significantly better in a subsequent simulation than students who did not have prior simulation experience (p < .001).
","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Craig', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: sjw5y@virginia.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kastello', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: jck9e@virginia.edu.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Cieslowski', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA. Electronic address: bjc6h@virginia.edu.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Rovnyak', 'Affiliation': 'University of Virginia, School of Nursing, Charlottesville, VA, USA.'}]",Nurse education today,['10.1016/j.nedt.2020.104605']
1241,33096392,Tocolysis compared with no tocolysis in women with threatened preterm birth and ruptured membranes: A propensity score analysis.,"INTRODUCTION
In women with preterm ruptured membranes and contractions, the administration of tocolysis is controversial. This study compares tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
OBJECTIVE
To compare tocolysis with no tocolysis in women with threatened preterm birth and ruptured membranes.
STUDY DESIGN
Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin. In the APOSTEL III trial, women with threatened preterm birth were randomized to atosiban or nifedipine. Patient data from Ireland were obtained from a cohort of women with threatened preterm birth with ruptured membranes. The Irish women received no tocolytic treatment. Only women with ruptured membranes and contractions were selected. We studied women with singleton or twin pregnancies and a gestational age between 25 +0 and 33 +6 weeks. Propensity score matching was performed to create comparable groups. Primary outcome was a composite adverse neonatal outcome. Secondary outcomes were individual components of the primary outcome, as well as neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery.
RESULTS
153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort. We could match 46 women who received tocolysis and 46 women who received no tocolysis. All women had ruptured membranes. Maternal age, BMI, parity and gestational age at study entry were comparable between the groups after matching. There were no statistically significant differences in neonatal composite outcome (9.6 % in the tocolysis group versus 18 % in the control group, OR 0.46, 95 % CI 0.13-1.63). We found a lower incidence of NICU admission in the tocolysis group (63 %) than in the control group (94 %; OR 0.11, 95 % CI 0.03-0.41), which could be explained by differences in national admission policies. There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
CONCLUSION
In this propensity score analysis of women with threatened preterm birth and ruptured membranes, tocolytic therapy did not alter composite adverse neonatal outcome or time to delivery.",2020,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","['women with threatened preterm birth with ruptured membranes', 'women with singleton or twin pregnancies and a gestational age between 25 +0 and 33 +6 weeks', 'women with threatened preterm birth and ruptured membranes', 'All women had ruptured membranes', '153 women from the Apostel III trial were compared with 51 eligible women of the Irish cohort', 'Data from the APOSTEL III RCT was combined with data from the National Maternity Hospital, Dublin', '46 women who received tocolysis and 46 women who received', 'women with threatened preterm birth']","['Tocolysis', 'tocolysis with no tocolysis', 'nifedipine', 'no tocolysis']","['sepsis, gestational age at delivery and time to delivery', 'neonatal intensive care unit (NICU) admission, gestational age at delivery, prolongation of pregnancy and mode of delivery', 'neonatal composite outcome', 'NICU admission', 'composite adverse neonatal outcome']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0233308', 'cui_str': 'Spontaneous rupture of fetal membranes'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020010', 'cui_str': 'Maternity Hospitals'}, {'cui': 'C0454777', 'cui_str': 'Dublin'}, {'cui': 'C0040348', 'cui_str': 'Tocolysis'}]","[{'cui': 'C0040348', 'cui_str': 'Tocolysis'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}]","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",153.0,0.295046,"There were no statistically significant differences between tocolysis and no tocolysis in any of the other outcomes including sepsis, gestational age at delivery and time to delivery.
","[{'ForeName': 'T M S', 'Initials': 'TMS', 'LastName': 'van Winden', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roos', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'T A J', 'Initials': 'TAJ', 'LastName': 'Nijman', 'Affiliation': 'Leiden University Medical Centre, Department of Obstetrics and Gynecology, Leiden, the Netherlands.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Kleinrouweler', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Olaru', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Ireland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pajkrt', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Oudijk', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Obstetrics, Amsterdam Reproduction and Development Research Institute, Amsterdam, the Netherlands. Electronic address: m.a.oudijk@amsterdamumc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.015']
1242,33098997,Overall survival with 3 or 6 months of adjuvant chemotherapy in Italian TOSCA phase 3 randomised trial.,"BACKGROUND
Oxaliplatin-based adjuvant chemotherapy is the standard treatment of high-risk colon cancer (CC). A shorter duration (3 months) can achieve a similar outcome [in terms of relapse-free survival (RFS)] to a longer duration. This study reports the overall survival (OS) analysis of the three or six colon adjuvant (TOSCA) phase III study. It assessed different adjuvant chemotherapy durations in patients with resected high-risk stage II and stage III CC.
MATERIAL AND METHODS
TOSCA was an open-label, phase III, multicentre, non-inferiority trial conducted in 130 Italian centres. Patients were randomly assigned, in a 1 : 1 ratio, to receive 3 months of standard doses of FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX. Patients with histologically confirmed high-risk stage II and III CC were included, with RFS being the primary end point. OS was a secondary end point.
RESULTS
From June 2007 to March 2013, 3759 patients were accrued. At a median follow-up of 7 years, the hazard ratio (HR) for RFS of the 3-month versus 6-month arms was 1.13; 95% confidence interval (CI) 0.99-1.29, P for non-inferiority = 0.380, P for superiority = 0.068, crossing the non-inferiority limit of 1.20. This result did not allow us to reject the null hypothesis of the inferiority of the 3-month arm. The HR for OS of the 3-month versus 6-month arms was 1.09 (95% CI 0.93-1.26, P for superiority = 0.288). At the last follow-up analysis, the absolute OS difference between arms was <1%.
CONCLUSIONS
The present analysis of the TOSCA trial does not indicate any significant difference in OS between the treatment groups. The extra benefit provided by the longer treatment should be balanced against the extra toxicity of more prolonged therapy. The trial is registered with ClinicalTrials.gov, registration number: NCT0064660.",2020,A shorter duration (3 months) can achieve a similar outcome (in terms of relapse-free survival [RFS]) to a longer duration.,"['Patients with histologically confirmed high-risk stage II and III CC', '130 Italian centres', 'patients with resected high-risk stage II and stage III CC', 'From June 2007 to March 2013, 3759 patients were accrued', 'high-risk colon cancer (CC']","['adjuvant chemotherapy', 'FOLFOX/CAPOX, or 6 months of FOLFOX/CAPOX', 'Oxaliplatin-based adjuvant chemotherapy']","['overall survival (OS', 'Overall survival', 'absolute OS difference', 'hazard ratio (HR) for RFS', 'OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}]",3759.0,0.310107,A shorter duration (3 months) can achieve a similar outcome (in terms of relapse-free survival [RFS]) to a longer duration.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Petrelli', 'Affiliation': 'Medical Oncology Unit, Treviglio, Caravaggio Hospital, Treviglio, Bergamo, Italy. Electronic address: faupe@libero.it.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rulli', 'Affiliation': 'Laboratory of Methodology for Clinical Research, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Cancer Center ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto - IRCCS, Padua, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dotti', 'Affiliation': 'Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ronzoni', 'Affiliation': 'Medical Oncology Unit, Ospedale San Raffaele - IRCCS, Milan, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Pella', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Pusceddu', 'Affiliation': 'Medical Oncology, University Hospital and University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Banzi', 'Affiliation': 'Medical Oncology Unit, AUSL-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Zampino', 'Affiliation': 'Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumours, IRCCS, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Yasmina', 'Affiliation': 'Medical Oncology Unit, Rovigo Hospital, Rovigo, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Marchetti', 'Affiliation': ""Medical Oncology Unit, Sant'Andrea Hospital, Sapienza University of Rome and IDI-IRCCS, Rome, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cantore', 'Affiliation': 'Medical Oncology Unit, ASST Mantova, Mantua, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rimassa', 'Affiliation': 'Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center-IRCCS, Rozzano (MI); Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (MI), Italy.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ciuffreda', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliero Universitaria San Giovanni Battista, Molinette, Turin, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology Unit, Azienda Ospedaliera San Paolo, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Zagonel', 'Affiliation': 'Medical Oncology Unit 1, Istituto Oncologico Veneto - IRCCS, Padua, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Maiello', 'Affiliation': 'Medical Oncology Unit, Hospital Casa Sollievo della Sofferenza-IRCCS, San Giovanni Rotondo, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology Unit, IRCCS San Martino-IST, Genoa, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.477']
1243,32680475,Impact of a smoking cessation program on smoking prevalence and food security among food pantry users - a study protocol for a pragmatic cluster randomised controlled trial.,"BACKGROUND
Among food pantry users there is a high prevalence of both smoking and food insecurity, which may be related to one another. This study aims to evaluate the impact of a smoking cessation program carried out in food pantries on the smoking status and the food security status of food pantry users.
METHODS / DESIGN
Before starting the cluster randomised controlled trial, stakeholders will be engaged to adapt a behavioural group counselling program for smoking cessation to the needs of the food pantry users in a pre study. Food pantry users and workers as well as other experts, such as smoking cessation trainers, social workers, and psychologists, will be involved, using the world café technique and telephone interviews and a qualitative thematic analysis for data analysis to design the concept of the intervention program will be applied. In the second phase, the impact of the intervention on the smoking status and on food insecurity will be investigated by a cluster randomised controlled trial. A total of 416 food pantry users across 32 clusters (food pantries) in Berlin, Germany, should be recruited and randomly assigned to either the intervention group or the waiting list control group. The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries. The primary outcomes 6 months after the treatment will be self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10 ppm of carbon monoxide), and increased food security level (the percentage of participants with an improved food security level).
DISCUSSION
This study will be the first long-term investigation into the effect of a smoking cessation program on smoking status and food insecurity. The results of this study will inform the implementation of smoking cessation programs in food pantries throughout Germany.
TRIAL REGISTRATION
Prospectively registered DRKS00020037 . Registered 29 April 2020.",2020,"The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries.","['416 food pantry users across 32 clusters (food pantries) in Berlin, Germany']","['behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy', 'smoking cessation program', 'behavioural group counselling program', 'waiting list control group']","['smoking prevalence and food security', 'self-reported continuous smoking abstinence, validated by exhaled carbon monoxide (< 10\u2009ppm of carbon monoxide), and increased food security level']","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0237547', 'cui_str': 'Group counseling'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0554824,"The intervention will consist of a behavioural group counselling program for smoking cessation, specially tailored for food pantry users, as well as optional nicotine replacement therapy and the implementation of environmental smoking reduction measures in the food pantries.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Simmet', 'Affiliation': 'Institute of Nutritional Medicine, Department of Nutritional Psychology, University of Hohenheim, Fruwirthstr. 12, 70593, Stuttgart, Germany. Anja.Simmet@uni-hohenheim.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Teut', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Luisenstraße 57, 10117, Berlin, Germany.'}, {'ForeName': 'Romy', 'Initials': 'R', 'LastName': 'Schleicher', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin, Luisenstraße 57, 10117, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bschaden', 'Affiliation': 'Institute of Nutritional Medicine, Department of Nutritional Psychology, University of Hohenheim, Fruwirthstr. 12, 70593, Stuttgart, Germany.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Stroebele-Benschop', 'Affiliation': 'Institute of Nutritional Medicine, Department of Nutritional Psychology, University of Hohenheim, Fruwirthstr. 12, 70593, Stuttgart, Germany.'}]",BMC public health,['10.1186/s12889-020-09232-0']
1244,32688143,"The effects of multidisciplinary rehabilitation on neuroimaging, biological, cognitive and motor outcomes in individuals with premanifest Huntington's disease.","BACKGROUND
Huntington's disease (HD) is a chronic, progressive neurodegenerative condition for which there are currently no proven disease-modifying therapies. Lifestyle factors have been shown to impact on the age of disease onset and progression of disease features. We therefore investigated the effects of a nine-month multidisciplinary rehabilitation intervention on neuroimaging, biological and clinical disease outcomes in individuals with premanifest HD.
METHODS
31 individuals with premanifest HD participated in the study. Eighteen participants underwent a nine-month multidisciplinary rehabilitation intervention comprising aerobic and resistance exercise, computerised cognitive training, dual-task training and sleep hygiene and nutritional guidance. The remaining 13 participants were allocated to a standard care control group. Neuroimaging, biological, cognitive, motor and cardiorespiratory fitness data was collected.
RESULTS
Participants displayed good adherence (87%) and compliance (85%) to the intervention. Maintenance of the shape of the right putamen was observed in the intervention group when compared to the control group. The intervention group displayed significant improvements in verbal learning and memory, attention, cognitive flexibility and processing speed following the intervention when compared to the control group. Performance on the mini-social cognition and emotional assessment (mini-SEA) was maintained in the intervention group, but decreased in the control group. No changes were observed in serum neurofilament light protein levels, postural stability outcomes or cardiorespiratory fitness.
CONCLUSION
This study adds to the accumulating body of literature to suggest that multidisciplinary rehabilitation is of clinical benefit for individuals with HD. Large randomised controlled trials are necessary to determine the extent to which benefits occur across the spectrum of the disease.",2020,"The intervention group displayed significant improvements in verbal learning and memory, attention, cognitive flexibility and processing speed following the intervention when compared to the control group.","['individuals with HD', 'individuals with premanifest HD', '31 individuals with premanifest HD participated in the study', ""individuals with premanifest Huntington's disease"", 'Eighteen participants underwent a nine-month']","['nine-month multidisciplinary rehabilitation intervention', 'multidisciplinary rehabilitation', 'multidisciplinary rehabilitation intervention comprising aerobic and resistance exercise, computerised cognitive training, dual-task training and sleep hygiene and nutritional guidance', 'standard care control group']","['serum neurofilament light protein levels, postural stability outcomes or cardiorespiratory fitness', 'mini-social cognition and emotional assessment (mini-SEA', 'good adherence', 'neuroimaging, biological, cognitive and motor outcomes', 'verbal learning and memory, attention, cognitive flexibility and processing speed']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0670902', 'cui_str': 'LIGHT Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}]",18.0,0.0225136,"The intervention group displayed significant improvements in verbal learning and memory, attention, cognitive flexibility and processing speed following the intervention when compared to the control group.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Bartlett', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Govus', 'Affiliation': 'School of Allied Health, Human Services & Sport, Department of Dietetics, Nutrition and Sport, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Rankin', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia; Centre for Sleep Science, School of Human Sciences, Faculty of Science, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lampit', 'Affiliation': 'Department of Psychiatry, University of Melbourne, Victoria, Australia; Department of Neurology, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Feindel', 'Affiliation': 'Centre for Microscopy, Characterisation and Analysis, University of Western Australia, Australia.'}, {'ForeName': 'Govinda', 'Initials': 'G', 'LastName': 'Poudel', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Wei-Peng', 'Initials': 'WP', 'LastName': 'Teo', 'Affiliation': 'National Institute of Education, Nanyang Technological University, Singapore.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Nellie', 'Initials': 'N', 'LastName': 'Georgiou-Karistianis', 'Affiliation': 'School of Psychological Sciences, The Turner Institute of Brain and Mental Health, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Mel R', 'Initials': 'MR', 'LastName': 'Ziman', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia; School of Biomedical Science, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Travis M', 'Initials': 'TM', 'LastName': 'Cruickshank', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Western Australia, Australia; Exercise Medicine Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia; Perron Institute for Neurological and Translational Science, Perth, Western Australia, Australia. Electronic address: t.cruickshank@ecu.edu.au.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117022']
1245,33066061,How does the Execution of the Pilates Method and Therapeutic Exercise Influence Back Pain and Postural Alignment in Children Who Play String Instruments? A Randomized Controlled Pilot Study.,"BACKGROUND
Inappropriate posture in children while playing some string instruments can cause back pain and alterations of the spine. To date, there is no research on the effect of exercise on children who play a musical instrument, although it is known that transversus abdominis muscle control through the Pilates method has shown pain reduction and posture improvement in this population.
OBJECTIVE
To assess the effectiveness of the Pilates method combined with therapeutic exercise with respect to therapeutic exercise exclusively in reducing pain and improving postural alignment in children playing string instruments applying a protocol of low dose to increase children's adherence to training.
METHODS
A randomized controlled pilot study was designed with two parallel intervention groups. Twenty-five children (10-14 years old) were randomized in two intervention groups: Pilates method with therapeutic exercise (experimental) and therapeutic exercise (control) for 4 weeks (50 min per day, one day per week). Two assessments were performed (before and after treatment) to assess back pain and shoulders and hips alignment using a visual analog scale and the Kinovea program.
RESULTS
Statistically significant differences were obtained for pain reduction before ( p = 0.04) and after ( p = 0.01) playing the instrument in the experimental group. There were no significant changes in alignment improvement in any of the two groups.
CONCLUSION
The application of a low dose of the Pilates method combined with therapeutic exercise could be a beneficial intervention for pain reduction before and after musical practice in children who play string instruments.",2020,Statistically significant differences were obtained for pain reduction before ( p = 0.04) and after ( p = 0.01) playing the instrument in the experimental group.,"['children playing string instruments', 'children who play string instruments', 'Children', 'Twenty-five children (10-14 years old']","['Pilates method with therapeutic exercise (experimental) and therapeutic exercise (control', 'Pilates method combined with therapeutic exercise']","['Back Pain and Postural Alignment', 'pain reduction', 'back pain and shoulders and hips alignment using a visual analog scale', 'pain and improving postural alignment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0443313', 'cui_str': 'Stringing'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",25.0,0.0647546,Statistically significant differences were obtained for pain reduction before ( p = 0.04) and after ( p = 0.01) playing the instrument in the experimental group.,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Poncela-Skupien', 'Affiliation': 'Integral Rehabilitation Center, CRI. 38001, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pinero-Pinto', 'Affiliation': 'Department of Physical Therapy, Faculty of Nursery, Physiotherapy and Podiatry, University of Seville, 41004 Seville, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Martínez-Cepa', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, 28003 Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Zuil-Escobar', 'Affiliation': 'Department of Physiotherapy, Faculty of Medicine, CEU-San Pablo University, 28003 Madrid, Spain.'}, {'ForeName': 'Rita Pilar', 'Initials': 'RP', 'LastName': 'Romero-Galisteo', 'Affiliation': 'Department of Physiotherapy, Faculty of Science Health, University of Málaga, 29016 Málaga, Spain.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Palomo-Carrión', 'Affiliation': 'Department of Nursery, Physiotherapy and Occupational Therapy, Faculty of Physiotherapy and Nursery, University of Castilla-La Mancha, 45071 Toledo, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17207436']
1246,33068631,"Recovery of reward function in problematic substance users using a combination of robotics, electrophysiology, and TMS.","BACKGROUND
Theoretical and empirical work suggest that addictive drugs potentiate dopaminergic reinforcement learning signals and disrupt the reward function of its neural targets, including the anterior midcingulate cortex (aMCC) and the basal ganglia. Here, we aim to use prefrontal 10-Hz TMS to enhance aMCC reward activity and reward learning by the basal ganglia in problematic substance users.
METHODS
22 problematic substance users were randomized into an Active and SHAM (coil flipped) TMS group. We recorded the reward positivity-an electrophysiological signal believed to index sensitivity of the aMCC to rewards-while participants engaged in 4 blocks (100 trials per block) of a reward-based choice task. A robotic arm positioned a TMS coil over a prefrontal cortex target, and 50 pulses were delivered at 10-Hz before every 10 trials of blocks 2-4 (1500 pulses, 400 trials). Participants then completed a decision-making task that is diagnostic of striatal dopamine dysfunction.
RESULTS
The present study revealed three main findings. First, both groups failed to elicit a reward positivity during the first two task blocks. Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks. Third, the Active group performed relatively better at reward-based learning than the SHAM group.
CONCLUSION
These results demonstrate that 10-Hz TMS is successful in modulating the reward function of the aMCC and basal ganglia in problematic substance users, which may have utility in the treatment of reward-related neural dysfunction commonly associated with substance use disorders.",2020,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","['22 problematic substance users', 'problematic substance users']","['10-Hz', 'TMS', 'robotics, electrophysiology, and TMS', 'Active and SHAM (coil flipped', 'robot-assisted TMS', 'prefrontal 10-Hz TMS']",['amplitude of the reward positivity'],"[{'cui': 'C0338666', 'cui_str': 'Misuses drugs'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0013865', 'cui_str': 'Electrophysiology'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}]",,0.128632,"Second, applying robot-assisted TMS enhanced the amplitude of the reward positivity in the Active group, but not the SHAM group, across the last two task blocks.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Biernacki', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Mei-Heng', 'Initials': 'MH', 'LastName': 'Lin', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America.'}, {'ForeName': 'Travis E', 'Initials': 'TE', 'LastName': 'Baker', 'Affiliation': 'Center for Molecular and Behavioral Neuroscience, Rutgers University-Newark, Newark, NJ 07102, United States of America. Electronic address: travis.e.baker@rutgers.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.08.008']
1247,33239108,Pharmacodynamic and pharmacokinetic behavior of landiolol during dobutamine challenge in healthy adults.,"BACKGROUND
To study the pharmacokinetic and -dynamic behavior of landiolol in the presence of dobutamine in healthy subjects of European ancestry.
METHODS
We conducted a single-center, prospective randomized study in 16 healthy subjects each receiving an infusion of dobutamine sufficient to increase heart rate by 30 bpm followed by a 60 min infusion of 10 μg/kg/min landiolol.
RESULTS
Dobutamine-induced increases in heart rate were stable for at least 20 min before a 60 min landiolol- infusion was started. The dobutamine effects were rapidly antagonized by landiolol within 16 min. A further slight decrease in heart rate during 20-60 min of the landiolol infusion occurred as well. Upon termination of landiolol infusion, heart rate and blood pressure recovered rapidly in response to the persisting dobutamine infusion but did not return to the maximum values before landiolol infusion. The pharmacokinetic parameters of landiolol in presence of dobutamine showed a short half-life (3.5 min) and a low distribution volume (0.3 l/kg). No serious adverse events were observed.
CONCLUSION
Landiolol can antagonize the dobutamine-induced increases in heart rate and blood pressure in a fast way. A rapid bradycardic effect until steady-state plasma levels is followed by a slow heart rate reduction. The latter can be attributed to an early desensitization to dobutamine. Consequently, after termination of landiolol, the heart rate did not achieve maximum pre-landiolol values. The pharmacokinetics of landiolol during dobutamine infusion are similar when compared to short- and long-term data in Caucasian subjects. Landiolol in the given dose can thus serve as an antagonist of dobutamine-induced cardiac effects.
TRIAL REGISTRATION
Registration number 2010-023311-34 at the EU Clinical Trials Register, registration date 2010-12-21.",2020,"No serious adverse events were observed.
","['healthy subjects of European ancestry', '16 healthy subjects each receiving an infusion of', 'healthy adults', 'Caucasian subjects', 'number 2010-023311-34 at the EU Clinical Trials Register, registration date 2010-12-21']","['dobutamine', '60\u2009min infusion of 10\u2009μg/kg/min landiolol']","['heart rate and blood pressure', 'heart rate', 'serious adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0012963', 'cui_str': 'Dobutamine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",16.0,0.0553056,"No serious adverse events were observed.
","[{'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Krumpl', 'Affiliation': 'MRN Medical Research Network GmbH, Postgasse 11/22, A-1010, Vienna, Austria. g.krumpl@medresnet.com.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Ulč', 'Affiliation': 'Center for Pharmacology and Analysis (CEPHA) s.r.o, Plzeň, Czech Republic.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Trebs', 'Affiliation': 'AOP Orphan Pharmaceuticals AG, Vienna, Austria.'}, {'ForeName': 'Pavla', 'Initials': 'P', 'LastName': 'Kadlecová', 'Affiliation': 'Aixial s.r.o., Brno, Czech Republic.'}, {'ForeName': 'Juri', 'Initials': 'J', 'LastName': 'Hodisch', 'Affiliation': 'AOP Orphan Pharmaceuticals AG, Vienna, Austria.'}]",BMC pharmacology & toxicology,['10.1186/s40360-020-00462-x']
1248,33069970,Labor neuraxial analgesia and breastfeeding: An updated systematic review.,"INTRODUCTION
There have been numerous reports studying the effect of neuraxial analgesia on breastfeeding success, but the results are inconsistent.
METHODS
We performed a literature search in various databases for studies comparing neuraxial analgesia to non-neuraxial or no analgesia. Outcomes were the percentage of women breastfeeding fully or mixed with formula. Where possible, nulliparous parturients were analyzed separately. We conducted an analysis excluding studies of serious and critical risk of bias. Odds ratios and 95% confidence intervals were calculated.
RESULTS
We included 15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants. Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results). In nulliparous only studies, 2 found no difference between study groups, 1 found a lower breastfeeding rate in the neuraxial group and 3 studies showed mixed results. Excluding studies with a serious and critical risk of bias, 1 study found no difference between study groups, 3 studies found a decrease of breastfeeding rates in the neuraxial group, and 1 study showed mixed results.
DISCUSSION
In our review we found a high disparity in results. One reason is probably the high potential of confounding (immediate skin to skin placement, maternity leave etc.). Education programs and breastfeeding support are likely more important in determining long term breastfeeding success.",2020,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","['nulliparous parturients', '15 studies (13 observational studies, 1 secondary analysis of a randomized controlled trial, 1 case-control study) with 16,112 participants']",['Labor neuraxial analgesia and breastfeeding'],"['breastfeeding rates', 'incidence of breastfeeding', 'breastfeeding rate']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007328', 'cui_str': 'Case Control Studies'}]","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",16112.0,0.0676764,"Overall, there were 6 studies that found no difference between groups, 6 studies that showed a significantly lower incidence of breastfeeding in the neuraxial group and 3 studies finding mixed results (at some time-points statistically significant and at some time-point statistically non-significant results).","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Heesen', 'Affiliation': 'Faculty of Medicine, University of Zurich, Winterthurerstrasse 190, 8057 Zurich, Switzerland. Electronic address: heesenphilip99@gmail.com.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Halpern', 'Affiliation': 'Department of Anesthesia, University of Toronto and Sunnybrook Health Sciences Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada. Electronic address: stephen.halpern@sunnybrook.ca.'}, {'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Beilin', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, and Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, 1468 Madison Avenue, New York, NY 10029, USA. Electronic address: yaakov.beilin@mountsinai.org.'}, {'ForeName': 'Paola A', 'Initials': 'PA', 'LastName': 'Mauri', 'Affiliation': ""School of Midwifery, Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Via della Commenda 19, 20122 Milano, Italy; Department of Mother Child and Newborn Health, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Italy. Electronic address: paola.mauri@unimi.it.""}, {'ForeName': 'Leonid A', 'Initials': 'LA', 'LastName': 'Eidelman', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: leidelman@clalit.org.il.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heesen', 'Affiliation': 'Department of Anesthesia, Kantonsspital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: michael.heesen@ksb.ch.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Orbach-Zinger', 'Affiliation': 'Department of Anesthesia, Rabin Medical Center, Beilinson Hospital, Zeev Jabutinskiy Rd 39, Petah Tikva 49100, Israel. Electronic address: sharonorbach@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110105']
1249,33069972,Efficacy of prothrombin complex concentrate for reversal of major bleeding due to rivaroxaban: A pilot randomized controlled trial.,,2020,,[],"['rivaroxaban', 'prothrombin complex concentrate']",[],[],"[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C4048712', 'cui_str': 'factor IX complex'}]",[],,0.158675,,"[{'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Shadvar', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Pariya', 'Initials': 'P', 'LastName': 'Sadaghi', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Hamishekar', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Mahmoodpoor', 'Affiliation': 'Department of Anesthesiology and intensive care medicine, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: amahmoodpoor@yahoo.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110093']
1250,33074695,Children's evaluations of individually and structurally based inequalities: The role of status.,"Social inequalities limit important opportunities and resources for members of marginalized and disadvantaged groups. Understanding the origins of how children construct their understanding of social inequalities in the context of their everyday peer interactions has the potential to yield novel insights into when-and how-individuals respond to different types of social inequalities. The present study examined whether children ( N = 176; 3- to 8-years-old; 52% female, 48% male; 70% European American, 16% African American, 10% Latinx, and 4% Asian American; middle-income backgrounds) differentiate between structurally based inequalities (e.g., based on gender) and individually based inequalities (e.g., based on merit). Children were randomly assigned to a group that received more (advantaged) or fewer (disadvantaged) resources than another group due to either their groups' meritorious performance on a task or the gender biases of the peer in charge of allocating resources. Overall, children evaluated structurally based inequalities to be more unfair and worthy of rectification than individually based inequalities, and disadvantaged children were more likely to view inequalities to be wrong and act to rectify them compared to advantaged children. With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair. Yet, the majority of children allocated equally in response to both types of inequality. The findings generated novel evidence regarding how children evaluate and respond to individually and structurally based inequalities, and how children's own status within the inequality informs these responses. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair.","['members of marginalized and disadvantaged groups', 'children ( N = 176; 3- to 8-years-old; 52% female, 48% male; 70% European American, 16% African American, 10% Latinx, and 4% Asian American; middle-income backgrounds) differentiate between structurally based inequalities (e.g., based on gender) and individually based inequalities (e.g., based on merit']","[""more (advantaged) or fewer (disadvantaged) resources than another group due to either their groups' meritorious performance on a task or the gender biases of the peer in charge of allocating resources""]",[],"[{'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0003988', 'cui_str': 'Asian Americans'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242503', 'cui_str': 'Unequal'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]","[{'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205906', 'cui_str': 'Gender Bias'}]",[],,0.0184298,"With age, advantaged children became more likely to rectify the inequalities and judge perpetuating allocations to be unfair.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Rizzo', 'Affiliation': 'New York University.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Killen', 'Affiliation': 'University of Maryland.'}]",Developmental psychology,['10.1037/dev0001118']
1251,33074709,Effect of endoplasmic reticulum stress on endothelial ischemia-reperfusion injury in humans.,"Endoplasmic reticulum stress contributes to ischemia-reperfusion (I/R) injury in rodent and cell models. However, the contribution of endoplasmic reticulum stress in the pathogenesis of endothelial I/R injury in humans is unknown. We tested the hypothesis that compared with placebo, inhibition of endoplasmic reticulum stress via ingestion of tauroursodeoxycholic acid would prevent the attenuation of endothelium-dependent vasodilation following I/R injury. Twelve young adults (6 women) were studied following ingestion of a placebo or 1,500 mg tauroursodeoxycholic acid (TUDCA). Endothelium-dependent vasodilation was assessed via brachial artery flow-mediated dilation (duplex ultrasonography) before and after I/R injury, which was induced by 20 min of arm ischemia followed by 20 min of reperfusion. Endothelium-independent vasodilation (glyceryl trinitrate-mediated vasodilation) was also assessed after I/R injury. Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng/ml and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid, by 560 ± 156 ng/ml (both P < 0.01). Ischemia-reperfusion injury attenuated endothelium-dependent vasodilation, an effect that did not differ between placebo (pre-I/R, 5.0 ± 2.1% vs. post-I/R, 3.5 ± 2.2%) and TUDCA (pre-I/R, 5.6 ± 2.1% vs. post-I/R, 3.9 ± 2.1%; P = 0.8) conditions. Similarly, endothelium-independent vasodilation did not differ between conditions (placebo, 19.6 ± 4.8% vs. TUDCA, 19.7 ± 6.1%; P = 0.9). Taken together, endoplasmic reticulum stress does not appear to contribute to endothelial I/R injury in healthy young adults.",2020,"Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1 and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1 (both P < 0.01).","['healthy young adults', 'Twelve young adults (six women', 'Humans']","['tauroursodeoxycholic acid', 'placebo or 1,500 mg tauroursodeoxycholic acid (TUDCA', 'placebo', 'ursodeoxycholic acid', 'Endoplasmic Reticulum Stress', 'placebo, TUDCA ingestion']","['circulating plasma concentrations', 'Endothelial Ischemia-Reperfusion Injury', 'endothelium-independent vasodilation', 'Endothelium-dependent vasodilation was assessed via brachial artery flow-mediated dilation (duplex ultrasonography', 'Endothelium-independent vasodilation (glyceryl trinitrate-mediated vasodilation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0075857', 'cui_str': 'tauroursodeoxycholic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}]",12.0,0.314787,"Compared with placebo, TUDCA ingestion increased circulating plasma concentrations by 145 ± 90 ng ml -1 and increased concentrations of the taurine unconjugated form, ursodeoxycholic acid by 560 ± 156 ng ml -1 (both P < 0.01).","[{'ForeName': 'Holden W', 'Initials': 'HW', 'LastName': 'Hemingway', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Moore', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Olivencia-Yurvati', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, Texas.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, Texas.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00257.2020']
1252,33079965,The effect of etidronate on choroidal neovascular activity in patients with pseudoxanthoma elasticum.,"AIM
To assess the effect of the bisphosphonate etidronate on choroidal neovascular (CNV) activity in patients with pseudoxanthoma elasticum (PXE).
METHODS
This is an ancillary study in a single center, randomized, double-blind placebo-controlled trial (RCT) in which 74 patients with PXE were assigned to either one-year etidronate or placebo treatment. Spectral domain optical coherence tomography (SD-OCT) imaging and color fundus photography were performed every three months for one year and were systematically assessed on signs of CNV activity.
RESULTS
In the etidronate group, 11 (30%) of the patients had CNV activity at baseline, compared to 25 (67%) of the patients in the placebo group (P = 0.005). The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168). Using a generalized mixed model for repeated measures, there was a protective effect of etidronate in crude analysis (RR 0.86, 95% CI 0.75-0.98) that disappeared when adjusting for baseline CNV activity (RR 0.97, 95% CI 0.84-1.13).
CONCLUSION
In this post-hoc RCT analysis we did not observe a protecting or deteriorating effect of etidronate on CNV activity in patients with PXE after adjustment for baseline CNV.",2020,The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168).,"['patients with pseudoxanthoma elasticum (PXE', 'patients with pseudoxanthoma elasticum', '74 patients with PXE']","['etidronate', 'placebo', 'bisphosphonate etidronate', 'etidronate or placebo']","['CNV activity', 'choroidal neovascular activity', 'improvement or worsening of CNV activity', 'choroidal neovascular (CNV) activity', 'proportion of eyes with CNV activity', 'baseline CNV activity ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033847', 'cui_str': 'Pseudoxanthoma elasticum'}]","[{'cui': 'C0086268', 'cui_str': 'Etidronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",74.0,0.315344,The proportion of eyes with CNV activity during the study ranged from 18-33% in the etidronate group and 42-56% in the placebo group and no significant difference in improvement or worsening of CNV activity was found (P = 0.168).,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Risseeuw', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Redmer', 'Initials': 'R', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Saskia M', 'Initials': 'SM', 'LastName': 'Imhof', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Pim A', 'Initials': 'PA', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Willem P Th M', 'Initials': 'WPTM', 'LastName': 'Mali', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Wilko', 'Initials': 'W', 'LastName': 'Spiering', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jeannette', 'Initials': 'J', 'LastName': 'Ossewaarde-van Norel', 'Affiliation': 'Department of Ophthalmology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0240970']
1253,33079968,Predicting overdose among individuals prescribed opioids using routinely collected healthcare utilization data.,"INTRODUCTION
With increasing rates of opioid overdoses in the US, a surveillance tool to identify high-risk patients may help facilitate early intervention.
OBJECTIVE
To develop an algorithm to predict overdose using routinely-collected healthcare databases.
METHODS
Within a US commercial claims database (2011-2015), patients with ≥1 opioid prescription were identified. Patients were randomly allocated into the training (50%), validation (25%), or test set (25%). For each month of follow-up, pooled logistic regression was used to predict the odds of incident overdose in the next month based on patient history from the preceding 3-6 months (time-updated), using elastic net for variable selection. As secondary analyses, we explored whether using simpler models (few predictors, baseline only) or different analytic methods (random forest, traditional regression) influenced performance.
RESULTS
We identified 5,293,880 individuals prescribed opioids; 2,682 patients (0.05%) had an overdose during follow-up (mean: 17.1 months). On average, patients who overdosed were younger and had more diagnoses and prescriptions. The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint). It outperformed simpler models based on few predictors (c-statistic 0.825, 95% CI 0.808-0.843) and baseline predictors only (c-statistic 0.806, 95% CI 0.787-0.26). Different analytic techniques did not substantially influence performance. In the final algorithm based on elastic net, the strongest predictors were age 18-25 years (OR: 2.21), prior suicide attempt (OR: 3.68), opioid dependence (OR: 3.14).
CONCLUSIONS
We demonstrate that sophisticated algorithms using healthcare databases can be predictive of overdose, creating opportunities for active monitoring and early intervention.",2020,"The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint).","['5,293,880 individuals prescribed opioids; 2,682 patients (0.05%) had an overdose during follow-up (mean: 17.1 months']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],[],2682.0,0.0579435,"The elastic net model achieved good performance (c-statistic 0.887, 95% CI 0.872-0.902; sensitivity 80.2, specificity 80.1, PPV 0.21, NPV 99.9 at optimal cutpoint).","[{'ForeName': 'Jenny W', 'Initials': 'JW', 'LastName': 'Sun', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Franklin', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rough', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Desai', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Hernández-Díaz', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Krista F', 'Initials': 'KF', 'LastName': 'Huybrechts', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Bateman', 'Affiliation': ""Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, United States of America.""}]",PloS one,['10.1371/journal.pone.0241083']
1254,33090739,Placebo 2.0: the impact of expectations on analgesic treatment outcome.,,2020,,[],['Placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.16047,,"[{'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': 'Klinik für Neurologie, Universitätsklinikum Essen, Universität Duisburg-Essen, Duisburg, Germany.'}]",Pain,['10.1097/j.pain.0000000000001981']
1255,33093338,Preliminary Evidence for the Fibromyalgia Integrative Training Program (FIT Teens) Improving Strength and Movement Biomechanics in Juvenile Fibromyalgia: Secondary Analysis and Results from a Pilot Randomized Clinical Trial.,"OBJECTIVES
Current therapies for juvenile fibromyalgia (JFM), such as cognitive-behavioral therapy (CBT), improve pain coping but are less effective for pain reduction or engagement in physical activity. The Fibromyalgia Integrative Training for Teens (FIT Teens) program combines CBT with specialized neuromuscular exercise training for adolescents with JFM. The current investigation examined the effects of FIT Teens versus CBT on secondary outcomes of strength and functional biomechanics, utilizing 3D Motion capture technology. This study aimed to explore improvements in strength and biomechanics in both a CBT-only group and the FIT Teens intervention.
MATERIALS AND METHODS
Forty adolescents with JFM (12 to 18 y) were randomized to an 8-week, group-based protocol of either FIT Teens or CBT only. Assessments occurred pretreatment and posttreatment. Hip and knee strength were assessed with dynamometry, dynamic postural stability was measured using the Star Excursion Balance Test, and movement biomechanics were assessed with 3D motion analyses during a drop vertical jump (DVJ) task.
RESULTS
The FIT Teens group exhibited improvements in hip abduction strength and greater external hip rotation during the DVJ task. Some differences between the FIT Teens and CBT groups were observed in peak hip internal moment in the transverse plane. Decreased hip adduction during the DVJ was also observed in the FIT Teens group.
DISCUSSION
Results suggest that the FIT Teens program shows promise in improving hip abduction strength and body biomechanics, indicating improvements in stability during functional movements. These improvements may facilitate ability to initiate and maintain regular physical activity in youth with widespread musculoskeletal pain.",2021,The FIT Teens group exhibited improvements in hip abduction strength and greater external hip rotation during the DVJ task.,"['Juvenile Fibromyalgia', 'adolescents with JFM', 'Fibromyalgia Integrative Training Program (FIT Teens', 'youth with widespread musculoskeletal pain', 'Forty adolescents with JFM (12-18▒', 'Juvenile Fibromyalgia (JFM']","['specialized neuromuscular exercise training', 'FIT Teens vs CBT']","['hip abduction strength and body biomechanics', 'strength and biomechanics', 'hip abduction strength and greater external hip rotation', 'peak hip internal moment', 'dynamometry, dynamic postural stability', 'Hip and knee strength', 'Star Excursion Balance Test, and movement biomechanics', 'Improving Strength and Movement Biomechanics', 'Decreased hip adduction']","[{'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}]",40.0,0.0300868,The FIT Teens group exhibited improvements in hip abduction strength and greater external hip rotation during the DVJ task.,"[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics, University of Kansas Medical Center.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'DiCesare', 'Affiliation': 'Sports Medicine.'}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Sports Medicine.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Pfeiffer', 'Affiliation': 'Divisions of Behavioral Medicine and Clinical Psychology.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Williams', 'Affiliation': 'Divisions of Behavioral Medicine and Clinical Psychology.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Kitchen', 'Affiliation': 'Sports Medicine.'}, {'ForeName': 'Tracy V', 'Initials': 'TV', 'LastName': 'Ting', 'Affiliation': ""Rheumatology, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Myer', 'Affiliation': 'Sports Medicine.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Kashikar-Zuck', 'Affiliation': 'Divisions of Behavioral Medicine and Clinical Psychology.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000888']
1256,33093340,Investigating the Effects of Cuing Medication Availability on Patient-controlled Analgesia Pump Usage in Pediatric Patients: Results of a Randomized Controlled Trial.,"OBJECTIVES
The study of patient-controlled analgesia (PCA) behaviors has led to a greater understanding of factors that affect the pain experience. Although PCA behaviors can be influenced by cues to medication availability, no studies have examined the effects of such cues in pediatric populations.
MATERIALS AND METHODS
This randomized controlled trial examined patient satisfaction with pain management, PCA behaviors, opioid consumption, and state anxiety in a sample of 125 postsurgical children and adolescents (7 to 17 y). Patients were randomized to a ""light"" group (lockout period status cued by light on the PCA button) or control group (no cues to medication availability).
RESULTS
Although cuing did not affect patient satisfaction with pain management (P=0.11), patients in the light group consumed significantly more opioid than those in the control group (adj. P=0.016). This effect was primarily because of children in the light group (median, 0.019; interquartile range, 0.012 to 0.036 mg/kg/h) consuming more opioid than children (12 y or younger) in control group (median, 0.015; interquartile range, 0.006 to 0.025 mg/kg/h) (P=0.007). In contrast to the control group, for patients in the light group, opioid consumption was unrelated to pain and the proportion of patients with a 1:1 injections:attempts ratio was higher (P<0.001) across the study period.
DISCUSSION
The overall pattern of results suggests that patients in the light group used their PCA in response to the light more than in response to their pain, which likely reflects operant influences on PCA behavior by pediatric patients.",2021,"Although cuing did not affect patient satisfaction with pain management (P=0.11), patients in the light group consumed significantly more opioid than those in the control group (adj.","['patient satisfaction with pain management, PCA behaviors, opioid consumption and state-anxiety in a sample of 125 post-surgical children and adolescents (7-17▒', 'Pediatric Patients']","['light"" group (lockout period status cued by light on PCA button) or control group (no cues to medication availability', 'Cuing Medication Availability']",['patient satisfaction with pain management'],"[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0453985', 'cui_str': 'Button'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0589623,"Although cuing did not affect patient satisfaction with pain management (P=0.11), patients in the light group consumed significantly more opioid than those in the control group (adj.","[{'ForeName': 'Keri R', 'Initials': 'KR', 'LastName': 'Hainsworth', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Czarnecki', 'Affiliation': ""Jane B. Pettit Pain and Headache Center, Children's Wisconsin.""}, {'ForeName': 'Pippa M', 'Initials': 'PM', 'LastName': 'Simpson', 'Affiliation': 'Quantitative Health Sciences, Medical College of Wisconsin.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Quantitative Health Sciences, Medical College of Wisconsin.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Davies', 'Affiliation': 'Department of Psychology, University of Wisconsin-Milwaukee, Milwaukee WI.'}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Mueller', 'Affiliation': 'Department of Biological Sciences, Kent State University, Kent, OH.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Weisman', 'Affiliation': 'Department of Anesthesiology.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000892']
1257,33094868,"Perfectionism, anorexia nervosa, and family treatment: How perfectionism changes throughout treatment and predicts outcomes.","OBJECTIVE
This study uses data from a multisite randomized clinical trial to study the role of perfectionism in family-based treatment (FBT) for adolescent anorexia nervosa (AN). The main aim is to examine the role of baseline perfectionism in treatment response.
METHOD
Adolescents (N = 158; ages 12-18; 89.2% female) and their families were randomized to receive either FBT or systemic family treatment for AN. Eating disorder (ED) pathology, obsessive-compulsive symptoms, and perfectionism were assessed at baseline, end of treatment, and 6- and 12-month follow-up. Linear regression analyses were used to test whether perfectionism and obsessive-compulsive symptoms at baseline predict ED pathology at all timepoints. An independent samples t test was used to test whether there was a significant difference in the change in perfectionism in either treatment group.
RESULTS
Baseline maladaptive perfectionism significantly predicted ED pathology but not ideal body weight at all timepoints. The model that included obsessive-compulsive symptoms also predicted ED pathology at all timepoints except 12-month follow-up. Perfectionism scores did not change during treatment regardless of treatment type.
DISCUSSION
Baseline perfectionism predicted treatment response in this study. Interventions might target perfectionism to improve treatment response in AN.",2020,The model that included obsessive-compulsive symptoms also predicted ED pathology at all timepoints except 12-month follow-up.,"['adolescent anorexia nervosa (AN', 'Adolescents (N = 158; ages 12-18; 89.2% female) and their families']","['FBT or systemic family treatment for AN', 'perfectionism in family-based treatment (FBT']","['perfectionism and obsessive-compulsive symptoms', 'Perfectionism scores', 'Eating disorder (ED) pathology, obsessive-compulsive symptoms, and perfectionism', 'Perfectionism, anorexia nervosa']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}]","[{'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}]",158.0,0.0432251,The model that included obsessive-compulsive symptoms also predicted ED pathology at all timepoints except 12-month follow-up.,"[{'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'W Stewart', 'Initials': 'WS', 'LastName': 'Agras', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lock', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Halmi', 'Affiliation': 'Department of Psychiatry, Weil Cornell Medical College, New York, New York, USA.'}]",The International journal of eating disorders,['10.1002/eat.23396']
1258,33096028,Diagnostic value of parameters from a spot urine sample for renal potassium loss in hypokalemia.,"BACKGROUND
We assessed the value of 1) a spot urine test for diagnosing hypokalemia caused by renal potassium loss, and 2) actual 24-hour urine potassium excretion (24 hUK-actual) for diagnosing hypokalemia caused by renal potassium loss in patients treated with potassium supplementation. The study population was from Southwest China.
METHODS
Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n = 67) and hypokalemia caused by extrarenal potassium loss (n = 63). Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated) were derived from spot urine samples collected on admission, before initiation of therapy. Patients received intravenous potassium chloride 0.4 or 0.6 g/h. 24 hUK-actual was detected in patients whose serum potassium did not return to normal after 24 h of therapy.
RESULTS
Patients with hypokalemia caused by renal potassium loss had significantly higher UK, UK/UCr, FEK, TTKG and 24 hUK-calculated compared to patients with hypokalemia caused by extrarenal potassium loss (P < 0.05). FEK predicted renal potassium loss in hypokalemia with high accuracy at a cut-off of 9.29% (sensitivity, 80.6%; specificity, 85.7%). The area under the curve for 24 hUK-actual in predicting renal potassium loss in patients with hypokalemia treated with low or high-dose potassium chloride infusion were 0.939 or 0.956, respectively. On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r = 0.831, p < 0.001 or r = 0.764, p < 0.001).
CONCLUSIONS
FEK from a spot urine sample represents a convenient and reliable parameter to predict renal potassium loss in patients with hypokalemia.",2020,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","['Patients with hypokalemia were divided into 2 groups: hypokalemia caused by renal potassium loss (n=67) and hypokalemia caused by extrarenal potassium loss (n=63', 'hypokalemia', 'The study population was from Southwest China', 'patients with hypokalemia', 'patients with hypokalemia treated with low or high-dose']","['potassium chloride infusion', 'intravenous potassium chloride', 'potassium supplementation']","['renal potassium loss', 'Urine potassium concentration (UK), urine creatinine concentration (UCr), urine potassium-creatinine ratio (UK/UCr), fractional excretion of potassium (FEK), transtubular potassium concentration gradient (TTKG), and 24-h urine potassium excretion (24 hUK-calculated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0360652', 'cui_str': 'Potassium-containing product in parenteral dose form'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0561938', 'cui_str': 'Potassium supplementation'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0202195', 'cui_str': 'Potassium measurement, urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1318439', 'cui_str': 'Creatinine measurement, urine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.0248461,"On the spot urine test, FEK showed the highest correlation with 24 hUK-actual during low or high dose potassium chloride infusion (r=0.831, p<0.001 or r=0.764, p<0.001).
","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China. Electronic address: lijia0876@126.com.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': 'Department of Endocriology, The Affiliated Hospital of Southwest Medical University, Luzhou, 646000 Sichuan, China.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.10.024']
1259,33096517,Bilateral ultrasound-guided erector spinae plane block in patients undergoing lumbar spinal fusion: A randomized controlled trial.,"STUDY OBJECTIVE
Spinal fusion surgery is associated with severe postoperative pain. We examined whether bilateral ultrasound-guided erector spinae plane block could alleviate postoperative pain in patients undergoing lumbar spinal fusion.
DESIGN
Blinded, randomized, controlled study.
SETTING
Tertiary university hospital, operating room, postoperative recovery room and ward.
PATIENTS
Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery were randomized into the erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio.
INTERVENTIONS
Pre-operative ultrasound-guided bilateral erector spinae plane block was performed in the ESPB group, while sham subcutaneous infiltration was performed in the control group.
MEASUREMENTS
The primary outcome was pain intensity at rest within 12 h postoperatively using the Numeric Rating Scale (NRS). Secondary outcomes included NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48 h after surgery.
MAIN RESULTS
The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023). The two groups showed similar pain scores at rest at 24 h after surgery (estimated mean difference - 0.2, 95% CI -0.8 to 0.5) and 48 h (-0.3, 95% CI -0.8 to 0.2). The ESPB group also showed significantly lower pain score on movement at 4 h after surgery (-1.5, 95% CI -2.5 to -0.6). The ESPB group showed a significantly smaller proportion of patients requiring sufentanil within 12 h after surgery (p = 0.020), and the group consumed significantly less sufentanil during that period (p = 0.042).
CONCLUSIONS
Bilateral ultrasound-guided erector spinae plane block improves postoperative analgesia in patients undergoing lumbar spinal fusion.",2020,"MAIN RESULTS
The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","['Sixty patients with American Society of Anesthesiologists grade I or II scheduled for lumbar spinal fusion surgery', 'patients undergoing lumbar spinal fusion', 'Tertiary university hospital, operating room, postoperative recovery room and ward']","['sufentanil', 'bilateral ultrasound-guided erector spinae plane block', 'Pre-operative ultrasound-guided bilateral erector spinae plane block', 'erector spinae plane block group (ESPB group) and the control group in a 1:1 ratio', 'ESPB', 'Bilateral ultrasound-guided erector spinae plane block']","['postoperative analgesia', 'pain intensity at rest within 12\xa0h postoperatively using the Numeric Rating Scale (NRS', 'smaller proportion of patients requiring sufentanil', 'pain score', 'pain scores', 'similar pain scores', 'NRS pain scores at rest and on movement, postoperative opioid consumption and proportions of patients requiring opioid during the first 48\xa0h after surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",60.0,0.356452,"MAIN RESULTS
The ESPB group (n = 30) showed significantly lower pain scores at rest at 4 h after surgery (estimated mean difference - 1.6, 95% confidence interval [CI] -2.4 to -0.8, p < 0.001), at 8 h (-1.3, 95% CI -1.9 to -0.6, p < 0.001), and at 12 h (-0.7, 95% CI -1.3 to -0.1, p = 0.023).","[{'ForeName': 'Qingfen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yaqing', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xizhe', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Anesthesiology, Peking University People's Hospital, Beijing, China. Electronic address: yifeng_65@163.com.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110090']
1260,33107132,Phase 1 trial for treatment of COVID-19 patients with pulmonary fibrosis using hESC-IMRCs.,,2020,,['COVID-19 patients with pulmonary fibrosis using hESC-IMRCs'],[],[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}]",[],[],,0.0164588,,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Tianda', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Institute for Stem Cell and Regeneration, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Zhongwen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Gao', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Baojie', 'Initials': 'B', 'LastName': 'Guo', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xianguang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, China.'}, {'ForeName': 'Baoyang', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of National Stem Cell Resource Center, Institute of Zoology, Chinese Academy of Sciences, Beijing, China.'}]",Cell proliferation,['10.1111/cpr.12944']
1261,33069172,Intensive versus guideline-recommended blood pressure reduction in acute lacunar stroke with intravenous thrombolysis therapy: The ENCHANTED trial.,"BACKGROUND AND PURPOSE
This was an investigation of the differential effects of early intensive versus guideline-recommended blood pressure (BP) lowering between lacunar and non-lacunar acute ischaemic stroke (AIS) in the BP arm of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS
In 1,632 participants classified as having definite or probable lacunar (n = 454 [27.8%]) or non-lacunar AIS according to pre-specified definitions based upon clinical and adjudicated imaging findings, mean BP changes over days 0-7 were plotted, and systolic BP differences by treatment between subgroups were estimated in generalized linear models. Logistic regression models were used to estimate the BP treatment effects on 90-day outcomes (primary, an ordinal shift of modified Rankin scale scores) across lacunar and non-lacunar AIS after adjustment for baseline covariables.
RESULTS
Most baseline characteristics, acute BP and other management differed between lacunar and non-lacunar AIS, but mean systolic BP differences by treatment were comparable at each time point (all p interaction > 0.12) and over 24 h post-randomization (-5.5, 95% CI -6.5, -4.4 mmHg in lacunar AIS vs. -5.6, 95% CI -6.3, -4.8 mmHg in non-lacunar AIS, p interaction = 0.93). The neutral effect of intensive BP lowering on functional outcome and the beneficial effect on intracranial haemorrhage were similar for the two subgroups (all p interaction > 0.19).
CONCLUSIONS
There were no differences in the treatment effect of early intensive versus guideline-recommended BP lowering across lacunar and non-lacunar AIS.",2020,There were no differences in the treatment effect of early intensive versus guideline-recommended BP lowering across lacunar and non-lacunar AIS.,"['1632 participants classified as having definite or probable lacunar (n=454 [27.8%]) or non-lacunar AIS', 'acute lacunar stroke with intravenous thrombolysis therapy']","['Intensive versus guideline-recommended blood pressure reduction', 'early intensive versus guideline-recommended blood pressure (BP) lowering between lacunar']","['ordinal shift of modified Rankin scale [mRS] scores) across lacunar and non-lacunar AIS', 'mean systolic BP difference', 'intracranial hemorrhage']","[{'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3178801', 'cui_str': 'Lacunar stroke'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}]",1632.0,0.0837521,There were no differences in the treatment effect of early intensive versus guideline-recommended BP lowering across lacunar and non-lacunar AIS.,"[{'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Mair', 'Affiliation': 'Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Woodward', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Departments of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'The George Institute for Global Health and University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Thompson G', 'Initials': 'TG', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences and NIHR Leicester Biomedical Research Center, University of Leicester, Leicester, UK.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'South Western Clinical School, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Wardlaw', 'Affiliation': 'Division of Neuroimaging Sciences, Edinburgh Imaging and Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}]",European journal of neurology,['10.1111/ene.14598']
1262,33239101,"The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study.","BACKGROUND
The indication for antibiotic prophylaxis in burn patients remains highly controversial, with no consensus having been reached. The objective of antibiotic prophylaxis is to reduce the risk of postoperative local and systemic infections. Burn surgery is associated with a high incidence of bacteremia, postoperative infections, and sepsis. However, antibiotic prophylaxis exposes patients to the risk of selecting drug-resistant pathogens as well as to the adverse effects of antibiotics (i.e., Clostridium difficile colitis). The lack of data precludes any strong international recommendations regarding perioperative prophylaxis using systemic antibiotics in this setting. The goal of this project is therefore to determine whether perioperative systemic antibiotic prophylaxis can reduce the incidence of postoperative infections in burn patients.
METHODS
The A2B trial is a multicenter (10 centers), prospective, randomized, double-blinded, placebo-controlled study. The trial will involve the recruitment of 506 adult burn patients with a total body surface area (TBSA) burn of between 5 and 40% and requiring at least one excision-graft surgery for deep burn injury. Participants will be randomized to receive antibiotic prophylaxis (antibiotic prophylaxis group) or a placebo (control group) 30 min before the incision of the first two surgeries. The primary outcome will be the occurrence of postoperative infections defined as postoperative sepsis and/or surgical site infection and/or graft lysis requiring a new graft within 7 days after surgery. Secondary outcomes will include mortality at day 90 postrandomization, skin graft lysis requiring a new graft procedure, postoperative bacteremia (within 48 h of surgery), postoperative sepsis, postoperative surgical site infection, number of hospitalizations until complete healing (> 95% TBSA), number of hospitalization days living without antibiotic therapy at day 28 and day 90, and multiresistant bacterial colonization or infection at day 28 and day 90.
DISCUSSION
The trial aims to provide evidence on the efficacy and safety of antibiotic prophylaxis for excision-graft surgery in burn patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04292054 . Registered on 2 March 2020.",2020,Participants will be randomized to receive antibiotic prophylaxis (antibiotic prophylaxis group) or a placebo (control group) 30 min before the incision of the first two surgeries.,"['506 adult burn patients with a total body surface area (TBSA) burn of between 5 and 40% and requiring at least one excision-graft surgery for deep burn injury', 'burn patients']","['antibiotic prophylaxis', 'placebo', 'antibiotic prophylaxis (antibiotic prophylaxis group) or a placebo (control group) 30\u2009min before the incision of the first two surgeries', 'excision-graft surgery']","['mortality at day 90 postrandomization, skin graft lysis requiring a new graft procedure, postoperative bacteremia (within 48\u2009h of surgery), postoperative sepsis, postoperative surgical site infection, number of hospitalizations until complete healing (>\u200995% TBSA), number of hospitalization days living without antibiotic therapy at day 28 and day 90, and multiresistant bacterial colonization or infection', 'occurrence of postoperative infections defined as postoperative sepsis and/or surgical site infection and/or graft lysis requiring a new graft within 7\u2009days after surgery', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0229978', 'cui_str': '90 percent of body surface or more'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]","[{'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037297', 'cui_str': 'Grafting to skin'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3698200', 'cui_str': 'Postoperative sepsis'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2747813', 'cui_str': 'Bacterial colonisation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",506.0,0.702161,Participants will be randomized to receive antibiotic prophylaxis (antibiotic prophylaxis group) or a placebo (control group) 30 min before the incision of the first two surgeries.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dépret', 'Affiliation': 'Department of Anaesthesiology, Critical Care Medicine and Burn unit, AP-HP, Saint Louis and Lariboisière University Hospitals, 1 Avenue Claude Vellefaux, 75010, Paris, France. depret.francois@gmail.com.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Farny', 'Affiliation': 'University of Paris, F-75475, Paris, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Jeanne', 'Affiliation': 'CHU Lille, Anaesthesia and Critical Care, Burn Centre, 59000, Lille, France.'}, {'ForeName': 'Kada', 'Initials': 'K', 'LastName': 'Klouche', 'Affiliation': 'Department of Intensive Care Unit, Hospital Lapeyronie, 55045, Montpellier, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leclerc', 'Affiliation': 'Percy Military Teaching Hospital, Clamart, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Nouette-Gaulain', 'Affiliation': ""CHU Bordeaux, Service d'Anesthésie Réanimation Pellegrin, Hôpital Pellegrin, Place Amélie Raba Léon, F-33000, Bordeaux, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Pantet', 'Affiliation': 'Medical Intensive Care, CHU Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Rémerand', 'Affiliation': ""Département d'Anesthésie-Réanimation Chirurgicale, Centre Hospitalier Universitaire de Tours, Tours, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Roquilly', 'Affiliation': 'Department of Anaesthesia and Critical Care, Hôtel-Dieu, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Rousseau', 'Affiliation': 'Department of Anesthesiology and Intensive Care, CHU Liège, Liège, Belgium.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Sztajnic', 'Affiliation': 'Intensive Care Unit, Department of Anesthesia and Critical Care, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Wiramus', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine and Burn Centre, University Hospital of Marseille, La Timone Hospital, Marseille, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'APHP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal Hospital, Paris, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Legrand', 'Affiliation': 'Department of Anaesthesiology, Critical Care Medicine and Burn unit, AP-HP, Saint Louis and Lariboisière University Hospitals, 1 Avenue Claude Vellefaux, 75010, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04894-y']
1263,33069667,The effectiveness of early parental coaching in the autism spectrum disorder.,"OBJECTIVE
Analysis of the effectiveness of early Parental Coaching in the Autism Spectrum Disorder.
METHOD
Randomized, controlled and blinded clinical trial to analyze parent-child interaction videos.
RESULTS
The sample consisted of 18 children being followed up at the Autism Outpatient Clinic of a Neuropediatric Center in southern Brazil diagnosed with Autism Spectrum Disorder, between 29 and 42 months of age, randomly allocated to two groups: the Study Group (SG; n=9), which received Parental Coaching performed by a professional certified by the ESDM (Early Start Denver Model); and the Control Group (CG; n=9), which was in a routine follow-up, without treatment and training of parents by a trained professional. The parents of the SG were willing to attend weekly meetings and to apply the instructional techniques at home with their children. It took 12 weeks and an average of 2h per meeting.
CONCLUSIONS
The learning rate for comprehensive development skills in the ESDM checklist, such as receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence was significantly higher in the SG, as well as the strategies and the quality of interaction between parents and children. Thus, Parental Coaching presents as a possibility of early intervention in children with Autism Spectrum Disorder.",2020,"The learning rate for comprehensive development skills in the ESDM checklist, such as receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence was significantly higher in the SG, as well as the strategies and the quality of interaction between parents and children.","['children with Autism Spectrum Disorder', '18 children being followed up at the Autism Outpatient Clinic of a Neuropediatric Center in southern Brazil diagnosed with Autism Spectrum Disorder, between 29 and 42 months of age', 'autism spectrum disorder']","['Parental Coaching performed by a professional certified by the ESDM (Early Start Denver Model); and the Control Group (CG; n\u202f=\u202f9), which was in a routine follow-up, without treatment and training of parents by a trained professional', 'early parental coaching', 'early Parental Coaching']","['receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",18.0,0.0346392,"The learning rate for comprehensive development skills in the ESDM checklist, such as receptive communication, expressive communication, social capacity, imitation, cognition, games, fine motor skills, gross motor skills, behavior, and personal independence was significantly higher in the SG, as well as the strategies and the quality of interaction between parents and children.","[{'ForeName': 'Edilici R S', 'Initials': 'ERS', 'LastName': 'Malucelli', 'Affiliation': 'Universidade Federal do Paraná, Hospital das Clínicas, Centro de Neurologia Pediátrica (CHC-UFPR), Curitiba, PR, Brazil. Electronic address: edilici@espacocomunicar.com.br.'}, {'ForeName': 'Sérgio Antônio', 'Initials': 'SA', 'LastName': 'Antoniuk', 'Affiliation': 'Universidade Federal do Paraná, Hospital das Clínicas, Centro de Neurologia Pediátrica (CHC-UFPR), Curitiba, PR, Brazil.'}, {'ForeName': 'Nicole Oliveira', 'Initials': 'NO', 'LastName': 'Carvalho', 'Affiliation': 'Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}]",Jornal de pediatria,['10.1016/j.jped.2020.09.004']
1264,33071098,Variation in opioid analgesia administration and discharge prescribing for emergency department patients with suspected urolithiasis.,"OBJECTIVE
Previous research has suggested caution about opioid analgesic usage in the emergency department (ED) setting and raised concerns about variations in prescription opioid analgesic usage, both across institutions and for whom they are prescribed. We examined opioid analgesic usage in ED patients with suspected urolithiasis across fifteen participating hospitals.
METHODS
This is a secondary analysis of a clinical trial including adult ED patients with suspected urolithiasis. In multilevel models accounting for clustering by hospital, we assessed demographic, clinical, state-level, and hospital-level factors associated with opioid analgesic administration during the ED visit and prescription at discharge.
RESULTS
Of 2352 participants, 67% received an opioid analgesic during the ED visit and 61% were prescribed one at discharge. Opioid analgesic usage varied greatly across hospitals, ranging from 46% to 88% (during visit) and 34% to 85% (at discharge). Hispanic patients were less likely than non-Hispanic white patients to receive opioid analgesics during the ED visit (OR 0.72, 95% CI 0.55-0.94). Patients with higher education (OR 1.29, 95% CI 1.05-1.59), health insurance coverage (OR 1.27, 95% CI 1.02-1.60), or receiving care in states with a prescription drug monitoring program (OR 1.64, 95% CI 1.06-2.53) were more likely to receive an opioid analgesic prescription at ED discharge.
CONCLUSION
We found marked hospital-level differences in opioid analgesic administration and prescribing, as well as associations with education, healthcare insurance, and race/ethnicity groups. These data might compel clinicians and hospitals to examine their opioid use practices to ensure it is congruent with accepted medical practice.",2020,"Patients with higher education (OR 1.29, 95% CI 1.05-1.59), health insurance coverage (OR 1.27, 95% CI 1.02-1.60), or receiving care in states with a prescription drug monitoring program (OR 1.64, 95% CI 1.06-2.53) were more likely to receive an opioid analgesic prescription at ED discharge.
","['emergency department patients with suspected urolithiasis', 'Of 2352 participants, 67% received an', 'Hispanic patients', 'adult ED patients with suspected urolithiasis', 'ED patients with suspected urolithiasis across fifteen participating hospitals']",['opioid analgesic'],"['health insurance coverage', 'Opioid analgesic usage']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0451641', 'cui_str': 'Urolithiasis'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}]",2352.0,0.101715,"Patients with higher education (OR 1.29, 95% CI 1.05-1.59), health insurance coverage (OR 1.27, 95% CI 1.02-1.60), or receiving care in states with a prescription drug monitoring program (OR 1.64, 95% CI 1.06-2.53) were more likely to receive an opioid analgesic prescription at ED discharge.
","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Wentz', 'Affiliation': 'Brown University School of Public Health, Department of Epidemiology, Box G-121-3, Providence, RI 02912, USA. Electronic address: a_wentz@brown.edu.'}, {'ForeName': 'Ralph R C', 'Initials': 'RRC', 'LastName': 'Wang', 'Affiliation': 'Emergency Medicine, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Ralph.Wang@ucsf.edu.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Brown University School of Public Health, Department of Epidemiology, Providence, RI, USA. Electronic address: brandon_marshall@brown.edu.'}, {'ForeName': 'Theresa I', 'Initials': 'TI', 'LastName': 'Shireman', 'Affiliation': 'Brown University School of Public Health, Health Services Policy & Practice, Providence, RI, USA. Electronic address: theresa_shireman@brown.edu.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Brown University School of Public Health, Data & Statistics Core of Brown Alcohol Research Center on HIV (ARCH), Providence, RI, USA. Electronic address: tliu@stat.brown.edu.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': ""Harvard Medical School, Brigham and Women's Hospital Department of Emergency Medicine, Boston, MA, USA. Electronic address: rmerchant@bwh.harvard.edu.""}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.07.016']
1265,33078673,Validation of Colorectal Cancer Models on Long-term Outcomes from a Randomized Controlled Trial.,"Microsimulation models are often used to predict long-term outcomes and guide policy decisions regarding cancer screening. The United Kingdom Flexible Sigmoidoscopy Screening (UKFSS) Trial examines a one-time intervention of flexible sigmoidoscopy that was implemented before a colorectal cancer (CRC) screening program was established. Long-term study outcomes, now a full 17 y following randomization, have been published. We use the outcomes from this trial to validate 3 microsimulation models for CRC to long-term study outcomes. We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening. We find that all 3 models yield predictions of the relative effect of screening on CRC incidence and mortality (i.e., the hazard ratios) that are reasonably close to the UKFSS results. Two of the 3 models accurately predict the relative reduction in CRC incidence 17 y after screening. One model accurately predicted the absolute incidence and mortality rates in the screened group. The models differ in their estimates related to adenoma detection at screening. Although high-quality screening results help to inform models, trials are expensive, last many years, and can be complicated by ethical issues and technological changes across the duration of the trial. Thus, well-calibrated and validated models are necessary to predict outcomes for which data are not available. The results from this validation demonstrate the utility of models in predicting long-term outcomes and in collaborative modeling to account for uncertainty.",2020,We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening.,[],"['flexible sigmoidoscopy', 'United Kingdom Flexible Sigmoidoscopy Screening (UKFSS']","['absolute incidence and mortality rates', 'CRC incidence and mortality']",[],"[{'cui': 'C0016234', 'cui_str': 'Flexible fiberoptic sigmoidoscopy'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",,0.0305501,We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'DeYoreo', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lansdorp-Vogelaar', 'Affiliation': 'Department of Public Health, Erasmus MC, Rotterdam, Zuid-Holland, the Netherlands.'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Knudsen', 'Affiliation': 'Institute for Technology Assessment and Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kuntz', 'Affiliation': 'Department of Health Policy and Management, University of Minnesota, School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, NY, USA.'}, {'ForeName': 'Carolyn M', 'Initials': 'CM', 'LastName': 'Rutter', 'Affiliation': 'RAND Corporation, Santa Monica, CA, USA.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20961095']
1266,33074943,"Comparison of adequacy of anaesthesia monitoring with standard clinical practice monitoring during routine general anaesthesia: An international, multicentre, single-blinded randomised controlled trial.","BACKGROUND
Previous studies have suggested that monitoring the levels of both hypnosis and antinociception could reduce periods of inadequate anaesthesia. However, the evidence regarding associated benefits of this monitoring is still limited.
OBJECTIVE
The primary objective of this study was to confirm that guidance of anaesthesia by depth of hypnosis and antinociception monitoring decreases the number of inadequate anaesthesia events in comparison with standard clinical practice.
DESIGN
A multicentre, single-blinded, randomised controlled trial.
SETTING
The study was conducted in four European University hospitals in four different countries between December 2013 and November 2016.
PATIENTS
The study population consisted of a total of 494 adult patients undergoing elective surgery requiring tracheal intubation.
INTERVENTIONS
The patients were allocated to one of two groups. The first group was treated using Entropy for depth of hypnosis and surgical pleth index to determine depth of antinociception (adequacy of anaesthesia group; AoA group). The second group was monitored using standard monitoring alone (control group). Anaesthesia was conducted with target-controlled infusions of propofol and remifentanil.
MAIN OUTCOME MEASURES
The primary outcome of the study was the number of total unwanted events for example signs of inadequately light or unintentionally deep anaesthesia.
RESULTS
Evidence of inadequate anaesthesia had an incidence of around 0.7 events per patient in both groups with no difference between groups (P = 0.519). In the AoA group, the overall consumption of propofol was significantly reduced (6.9 vs. 7.5 mg kg h, P = 0.008) in comparison with the control group. The consumption of remifentanil was equal in both groups. The times to emergence [8.0 vs. 9.6 min (P = 0.005)] and full recovery in the postanaesthesia care unit (P = 0.043) were significantly shorter in the AoA group. No differences were seen in postoperative pain scores or in the use of analgesics.
CONCLUSION
In the current study, the guidance of total intravenous anaesthesia by Entropy and surgical pleth index in comparison with standard monitoring alone was not able to validate reduction of unwanted anaesthesia events. However, there was a reduction in the use of propofol, and shorter times for emergence and time spent in the postanaesthesia care unit.
TRIAL REGISTRATION
at ClinicalTrials.gov NCT01928875.",2021,The times to emergence [8.0 vs. 9.6 min (P = 0.005)] and full recovery in the postanaesthesia care unit (P = 0.043) were significantly shorter in the AoA group.,"['routine general anaesthesia', '494 adult patients undergoing elective surgery requiring tracheal intubation', 'four European University hospitals in four different countries between December 2013 and November 2016']","['propofol', 'propofol and remifentanil', 'anaesthesia monitoring with standard clinical practice monitoring']","['number of total unwanted events for example signs of inadequately light or unintentionally deep anaesthesia', 'overall consumption of propofol', 'consumption of remifentanil', 'postoperative pain scores', 'number of inadequate anaesthesia events']","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0475747', 'cui_str': 'Deep anesthesia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",494.0,0.101793,The times to emergence [8.0 vs. 9.6 min (P = 0.005)] and full recovery in the postanaesthesia care unit (P = 0.043) were significantly shorter in the AoA group.,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gruenewald', 'Affiliation': ''}, {'ForeName': 'Jarkko', 'Initials': 'J', 'LastName': 'Harju', 'Affiliation': ''}, {'ForeName': 'Benedikt', 'Initials': 'B', 'LastName': 'Preckel', 'Affiliation': ''}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Molnár', 'Affiliation': ''}, {'ForeName': 'Arvi', 'Initials': 'A', 'LastName': 'Yli-Hankala', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rosskopf', 'Affiliation': ''}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Koers', 'Affiliation': ''}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Orban', 'Affiliation': ''}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Bein', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001357']
1267,33079754,An Evolutionary Medicine Perspective on Treatment of Pediatric Functional Abdominal Pain.,"In a recent issue, Kovacic et al. analyze data from a randomized sham-controlled trial and show that pretreatment vagal efficiency, an index related to respiratory sinus arrhythmia, is a predictor of pain improvement in adolescents with functional abdominal pain when treated with auricular percutaneous electrical nerve field stimulation. The underlying premise is the polyvagal hypothesis, an explanatory framework for the evolution of the mammalian autonomic nervous system, which proposes that functional gastrointestinal disorders can result from a chronic maladaptive state of autonomic neural control mechanisms after traumatic stress. This is an opportunity for us to stimulate physicians' interest in evolutionary medicine.",2020,"The underlying premise is the polyvagal hypothesis, an explanatory framework for the evolution of the mammalian autonomic nervous system, which proposes that functional gastrointestinal disorders can result from a chronic maladaptive state of autonomic neural control mechanisms after traumatic stress.","['adolescents with functional abdominal pain when treated with auricular percutaneous electrical nerve field stimulation', 'Pediatric Functional Abdominal Pain']",[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",[],[],,0.0257708,"The underlying premise is the polyvagal hypothesis, an explanatory framework for the evolution of the mammalian autonomic nervous system, which proposes that functional gastrointestinal disorders can result from a chronic maladaptive state of autonomic neural control mechanisms after traumatic stress.","[{'ForeName': 'Grigorios I', 'Initials': 'GI', 'LastName': 'Leontiadis', 'Affiliation': 'Division of Gastroenterology and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Longstreth', 'Affiliation': 'Department of Gastroenterology, Kaiser Permanente Southern California, San Diego, California, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000001024']
1268,33080411,The effect of dietary nitrate on exercise capacity in chronic kidney disease: a randomized controlled pilot study.,"BACKGROUND
Chronic Kidney Disease (CKD) patients exhibit a reduced exercise capacity that impacts quality of life. Dietary nitrate supplementation has been shown to have favorable effects on exercise capacity in disease populations by reducing the oxygen cost of exercise. This study investigated whether dietary nitrates would acutely improve exercise capacity in CKD patients.
METHODS AND RESULTS
In this randomized, double-blinded crossover study, 12 Stage 3-4 CKD patients (Mean ± SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6 ml/min/1.73 m 2 ) received an acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA). Skeletal muscle mitochondrial oxidative function was assessed using near-infrared spectroscopy. Cardiopulmonary exercise testing was performed on a cycle ergometer, with intensity increased by 25 W every 3 min until volitional fatigue. Plasma nitric oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound NO) were determined by gas-phase chemiluminescence. Plasma NOm values were significantly increased following BRJ (BRJ vs. PLA: 1074.4 ± 120.4 μM vs. 28.4 ± 6.6 μM, p < 0.001). Total work performed (44.4 ± 10.6 vs 39.6 ± 9.9 kJ, p = 0.03) and total exercise time (674 ± 85 vs 627 ± 86s, p = 0.04) were significantly greater following BRJ. Oxygen consumption at the ventilatory threshold was also improved by BRJ (0.90 ± 0.08 vs. 0.74 ± 0.06 L/min, p = 0.04). These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p = 0.52) and VO 2peak (p = 0.35).
CONCLUSIONS
Our findings demonstrate that inorganic nitrate can acutely improve exercise capacity in CKD patients. The effects of chronic nitrate supplementation on CKD related exercise intolerance should be investigated in future studies.",2020,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak (p=0.35).
","['12 Stage 3-4 CKD patients (Mean±SEM: Age, 60 ± 5yrs; eGFR, 50.3 ± 4.6ml/min/1.73m 2 ) received an', 'Chronic Kidney Disease (CKD) patients', 'CKD patients', 'chronic kidney disease']","['chronic nitrate supplementation', 'dietary nitrate', 'acute dose of 12.6 mmol of dietary nitrate in the form of concentrated beetroot juice (BRJ) and a nitrate depleted placebo (PLA', 'BRJ (BRJ vs. PLA', 'dietary nitrates', 'Dietary nitrate supplementation', 'inorganic nitrate']","['total exercise time', 'Oxygen consumption', 'skeletal muscle mitochondrial oxidative capacity', 'Plasma NOm values', 'Plasma Nitric Oxide (NO) metabolites (NOm; nitrate, nitrite, low molecular weight S-nitrosothiols, and metal bound', 'exercise capacity', 'Skeletal muscle mitochondrial oxidative function']","[{'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0429931', 'cui_str': 'Total exercise time'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0141313', 'cui_str': 'S-Nitrosothiol'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.142506,"These changes occurred in the absence of improved skeletal muscle mitochondrial oxidative capacity (p=0.52) and VO 2peak (p=0.35).
","[{'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology, West Chester University, West Chester, PA, USA.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Kirkman', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; Department of Kinesiology and Health Sciences, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Stock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Bryce J', 'Initials': 'BJ', 'LastName': 'Muth', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA; School of Health Sciences, Stockton University, Stockton, NJ, USA.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Division of Cardiovascular Medicine. Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Paschalis-Thomas', 'Initials': 'PT', 'LastName': 'Doulias', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Ischiropoulos', 'Affiliation': ""Laboratory of Biochemistry, Department of Chemistry, School of Sciences, University of Ioannina, Ioannina, 45110, Greece; Children's Hospital of Philadelphia Research Institute, Philadelphia, PA, USA.""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE, USA. Electronic address: dge@udel.edu.'}]",Nitric oxide : biology and chemistry,['10.1016/j.niox.2020.10.002']
1269,33080415,Prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. Α double-blinded randomized controlled trial.,"BACKGROUND
Spinal anesthesia for cesarean section can be complicated by hypotension, with untoward effects for both the mother and fetus. Frequently used phenylephrine can lead to baroreceptor-mediated reflex bradycardia. The aim of the present study was to compare a fixed-rate prophylactic norepinephrine infusion to a fixed-rate prophylactic phenylephrine infusion during elective cesarean section under combined spinal-epidural anesthesia.
MATERIALS AND METHODS
Eighty-two parturients were randomized to either norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution. The primary endpoint was the incidence of maternal bradycardia. Maternal hemodynamics at specific timepoints, the incidence of hypotension or hypertension, the requirement for ephedrine or atropine bolus administration as well as the acid-base status and Apgar score of the neonate were recorded.
RESULTS
The incidence of bradycardia as well as the requirement for atropine administration was lower in the norepinephrine group (4.8% vs. 31.7%, p = 0.004 and 2.4% vs. 24.3%, p = 0.01, respectively). Fetal pH, and fetal blood glucose concentration were higher in the norepinephrine group (p = 0.027 and 0.019, respectively). No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
CONCLUSIONS
A fixed-rate infusion of norepinephrine is as effective in the management of hypotension during regional anesthesia for cesarean section as a fixed-rate infusion of phenylephrine, with the avoidance of phenylephrine-induced bradycardia. The more favourable neonatal acid-base profile of noradrenaline might be due to better maintenance of placental blood flow in the noradrenaline group due to its beta action, while the higher fetal glucose concentration in the same group might result from a catecholamine-stimulated glucose metabolism increase and a β-receptor mediated insulin decrease.",2020,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","['Eighty-two parturients', 'hypotension during elective cesarean section with a']","['norepinephrine', 'fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine', 'norepinephrine 4 μg/min or phenylephrine 50 μg/min fixed-rate infusions, starting simultaneously with the administration of the subarachnoid solution', 'phenylephrine', 'phenylephrine infusion']","['Maternal hemodynamics', 'incidence of hypotension or hypertension', 'incidence of bradycardia', 'occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores', 'fetal glucose concentration', 'Fetal pH, and fetal blood glucose concentration', 'incidence of maternal bradycardia', 'placental blood flow']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0038527', 'cui_str': 'Subarachnoid space structure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",82.0,0.245385,"No difference in the occurrence of hypotension, hypertension, in the requirement for bolus vasoconstrictive medication or in Apgar scores was demonstrated.
","[{'ForeName': 'Kassiani', 'Initials': 'K', 'LastName': 'Theodoraki', 'Affiliation': '1st Department of Anesthesiology, Aretaieion University Hospital, National and Kapodistrian University of Athens, Greece. Electronic address: ktheodoraki@hotmail.com.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Hadzilia', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Valsamidis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Stamatakis', 'Affiliation': 'Department of Anesthesiology, Alexandra General Hospital of Athens, Greece.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.10.006']
1270,33085686,An experimental study of messages communicating potential harms of electronic cigarettes.,"There has been an upsurge of e-cigarette use in the United States in recent years. While e-cigarettes may contain lower levels of toxic chemicals than combusted cigarettes, they still pose serious health hazards, including increased risk for heart and respiratory disease. Despite these risks, public awareness of the health harms of e-cigarettes remains low. Thus, it is important to educate the public about the potential harms of e-cigarettes. This study took themes commonly found in antismoking messages and used them to develop messages about harms of e-cigarettes. A national sample of 2801 current smokers and nonsmokers (aged 18+ years) were randomized to view one of four e-cigarette messages (harmful effect of chemicals, uncertainty about ingredients, distrust of big tobacco, or cost of vaping) or a control message (bottled water ad). Participants' reactions to the messages and behavioral intentions were assessed immediately following the exposure. MANOVA examined effects of the messages on blocks of the outcome variables and univariate analyses estimated adjusted means for each experimental condition for each outcome. The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05). However, on measures of actual effectiveness, the other messages performed equally well. Specifically, messages with different themes (harmful chemicals, uncertainty about ingredients, anti-industry, or financial cost) increased perceived risk of e-cigarettes, support for e-cigarette control, and lowered self-exempting beliefs and intentions to use e-cigarettes (Ps<0.05). Themes commonly used in anti-smoking messages may be effective in educating the public about the potential harm of e-cigarettes. The observed differential effects of the messages suggest the need to use multiple themes in a public education campaign about e-cigarettes.",2020,The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05).,['2801 current smokers and nonsmokers (aged 18+ years'],"['cigarette messages (harmful effect of chemicals, uncertainty about ingredients, distrust of big tobacco, or cost of vaping) or a control message (bottled water ad']","['risk of e-cigarettes, support for e-cigarette control, and lowered self-exempting beliefs and intentions to use e-cigarettes', 'actual effectiveness']","[{'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1572482', 'cui_str': 'Bottled Water'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",2801.0,0.0207487,The message about harmful chemicals was perceived as the most informative and effective and elicited the highest levels of negative emotions (Ps<0.05).,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Owusu', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Massey', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Popova', 'Affiliation': 'School of Public Health, Georgia State University, Atlanta, Georgia, United States of America.'}]",PloS one,['10.1371/journal.pone.0240611']
1271,33089783,Sedentariness and Back Health in Western Cape Primary School Students: Protocol for a Pragmatic Stepped-Wedge Feasibility Randomized Controlled Trial.,"BACKGROUND
Despite growing evidence of deleterious health outcomes associated with sedentary behavior, prolonged static sitting in classrooms remains ubiquitous in primary schools. Sedentary behavior is associated with the development of cardio-metabolic conditions and poor back health. Preventative strategies to reduce sedentary behavior and its negative health effects may be required in a resource-constrained environment such as South Africa.
OBJECTIVE
The primary objective of this study is to assess the feasibility of conducting a full trial to evaluate the effects of a multifaceted intervention comprising novel multifunctional classroom furniture and a video-based curriculum versus usual care on sedentary behavior among students aged 10-11 years in primary schools. The secondary objective is to assess the preliminary effects of the intervention on sedentary behavior and postural dynamism.
METHODS
Eighty grade 5 or 6 students, aged 10 and 11 years, in mixed-gender schools within the Western Cape metropolitan urban area in Cape Town, South Africa are eligible to participate in this pilot cluster stepped-wedge trial design with classroom as the unit of randomization. Data will be collected at the schools. The intervention will comprise multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum on sedentary behavior. Usual practice is the absence of the intervention. The primary outcomes assessed will be (1) adherence to the intervention and (2) project pragmatics. The secondary outcomes will be (1) sedentariness measured using activPAL3 microsensors and (2) postural dynamism measured using Noraxon Myomotion inertial measurement units. We randomized the school to the first or second start of the intervention. This is an open-label trial and therefore blinding will not be possible for any group. Descriptive analysis of the feasibility and physiological outcomes will be presented. We will report the preliminary estimates of the effects of the intervention on sedentariness and postural dynamism using the mean difference and 95% CI.
RESULTS
At the time of submission, two classrooms have been recruited into the study. Baseline physical activity and postural dynamism data have been collected from 10 participants from each class.
CONCLUSIONS
The results of this feasibility stepped-wedge cluster randomized controlled trial will be useful in informing the design of the main trial to assess whether this multifaceted intervention of multifunctional classroom furniture that allows for sitting and standing as well as a video-based curriculum versus usual care has any effect on sedentary behavior in low-resource-setting primary schools.
TRIAL REGISTRATION
Pan African Trials Registry PACTR201811799476016; https://tinyurl.com/y4upoys8.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR1-10.2196/18522.",2020,To assess the feasibility of conducting a full trial to evaluate the effects of a multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care on sedentary behaviour among students aged between 10 and 11 years old in primary schools.,"['Western Cape school learners', 'Participants', 'Eighty grade 5 or 6 learners, aged 10 and 11 years old, in mixed-gender, schools within the Cape Metro urban area are eligible to participate', 'Setting: Western Cape Metropolitan Urban Area in South Africa', '10 participants from each class', 'students aged between 10 and 11 years old in primary schools']","['multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care', 'Intervention']","['Sedentariness and back health', 'activPAL3 micro sensors, and ii) postural dynamism measured using Noraxon Myomotion IMUs', 'Baseline physical activity and postural dynamism data', 'sedentary behaviour and postural dynamism']","[{'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016858', 'cui_str': 'Furniture'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",2.0,0.160256,To assess the feasibility of conducting a full trial to evaluate the effects of a multi-faceted intervention comprising novel multi-functional classroom furniture and a video-based curriculum versus usual care on sedentary behaviour among students aged between 10 and 11 years old in primary schools.,"[{'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Fisher', 'Affiliation': 'Division of Physiotherapy, Department of Health and Rehabilitation Sciences, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Quinette', 'Initials': 'Q', 'LastName': 'Louw', 'Affiliation': 'Department of Health and Rehabilitation Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact (formerly the Department of Clinical Epidemiology and Biostatistics), McMaster University, Hamilton, ON, Canada.'}]",JMIR research protocols,['10.2196/18522']
1272,33091192,INEXAS: A Phase 2 Randomized Trial of On-demand Inhaled Interferon Beta-1a in Severe Asthmatics.,"BACKGROUND
Upper respiratory tract infections (URTIs) are important triggers for asthma exacerbations. We hypothesized that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.
OBJECTIVE
To evaluate the efficacy of on-demand inhaled IFN-β1a (AZD9412) to prevent severe asthma exacerbations following symptomatic URTI.
METHODS
This was a randomized, double-blind, placebo-controlled trial in which patients with severe asthma (GINA 4-5; n = 121) reporting URTI symptoms were randomized to 14 days of once-daily nebulized AZD9412 or placebo. The primary endpoint was severe exacerbations during treatment. Secondary endpoints included 6-item asthma control questionnaire (ACQ-6) and lung function. Exploratory biomarkers included IFN-response markers in serum and sputum, blood leucocyte counts and serum inflammatory cytokines.
RESULTS
Following a pre-planned interim analysis, the trial was terminated early due to an unexpectedly low exacerbation rate. Asthma worsenings were generally mild and tended to peak at randomization, possibly contributing to the lack of benefit of AZD9412 on other asthma endpoints. Numerically, AZD9412 did not reduce severe exacerbation rate, ACQ-6, asthma symptom scores or reliever medication use. AZD9412 improved lung function (morning peak expiratory flow; mPEF) by 19.7 L/min. Exploratory post hoc analyses indicated a greater mPEF improvement by AZD9412 in patients with high blood eosinophils (>0.3 × 10 9 /L) at screening and low serum interleukin-18 relative change at pre-treatment baseline. Pharmacodynamic effect of AZD9412 was confirmed using IFN-response markers.
CONCLUSIONS & CLINICAL RELEVANCE
Colds did not have the impact on asthma patients that was expected and, due to the low exacerbation rate, the trial was stopped early. On-demand AZD9412 treatment did not numerically reduce the number of exacerbations, but did attenuate URTI-induced worsening of mPEF. Severe asthma patients with high blood eosinophils or low serum interleukin-18 response are potential subgroups for further investigation of inhaled IFN-β1a.",2020,"We hypothesised that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.",['Severe Asthmatics'],['INEXAS'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",[],[],,0.0925001,"We hypothesised that inhalation of the anti-viral cytokine, interferon (IFN)-β, during URTI, could prevent these exacerbations.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCrae', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Olsson', 'Affiliation': 'Early Biometrics and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Gustafson', 'Affiliation': 'BioPharmaceutical Medical, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Malmgren', 'Affiliation': 'Early Respiratory & Immunology Projects Department, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Aurell', 'Affiliation': 'Early Respiratory & Immunology Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Fagerås', 'Affiliation': 'BioPharmaceutical Medical, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Da Silva', 'Affiliation': 'Early Respiratory & Immunology Clinical Development, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Cavallin', 'Affiliation': 'Translational Science and Experimental Medicine, Early Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Paraskos', 'Affiliation': 'Point of Care Diagnostics, Precision Medicine, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Karlsson', 'Affiliation': 'Translational Science and Experimental Medicine, Early Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Wingren', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory & Immunology, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Monk', 'Affiliation': 'Synairgen Research Ltd, Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Marsden', 'Affiliation': 'Synairgen Research Ltd, Southampton University Hospital, Southampton, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham NIHR Biomedical Research Centre, University of Nottingham, Nottingham City Hospital, Nottingham, UK.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13765']
1273,33092805,"Impact of intraoperative goal-directed fluid therapy on major morbidity and mortality after transthoracic oesophagectomy: a multicentre, randomised controlled trial.","BACKGROUND
Transthoracic oesophagectomy is associated with major morbidity and mortality, which may be reduced by goal-directed therapy (GDT). The aim of this multicentre, RCT was to evaluate the impact of intraoperative GDT on major morbidity and mortality in patients undergoing transthoracic oesophagectomy.
METHODS
Adult patients undergoing transthoracic oesophagectomy were randomised to receive either minimally invasive intraoperative GDT (stroke volume variation <8%, plus systolic BP maintained >90 mm Hg by pressors as necessary) or haemodynamic management left to the discretion of attending senior anaesthetists (control group; systolic BP >90 mm Hg alone). The primary outcome was the incidence of death or major complications (reoperation for bleeding, anastomotic leakage, pneumonia, reintubation, >48 h ventilation). A Cox proportional hazard model was used to examine whether the effects of GDT on morbidity and mortality were independent of other potential confounders.
RESULTS
A total of 232 patients (80.6% male; age range: 36-83 yr) were randomised to either GDT (n=115) or to the control group (n=117). After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09 [95% CI: 0.01-0.67]). GDT was independently associated with morbidity and mortality (hazard ratio: 0.51 [95% CI: 0.30-0.87]; P=0.013).
CONCLUSIONS
Intraoperative GDT may reduce major morbidity and mortality, and shorten hospital stay, after transthoracic oesophagectomy.
CLINICAL TRIAL REGISTRATION
UMIN000018705.",2020,"After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09","['patients undergoing transthoracic oesophagectomy', 'Adult patients undergoing transthoracic oesophagectomy', '232 patients (80.6% male; age range: 36-83 yr']","['intraoperative goal-directed fluid therapy', 'Intraoperative GDT', 'Transthoracic oesophagectomy', 'GDT', 'intraoperative GDT', 'transthoracic oesophagectomy', 'minimally invasive intraoperative GDT (stroke volume variation <8%, plus systolic BP maintained >90 mm Hg by pressors as necessary) or haemodynamic management left to the discretion of attending senior anaesthetists (control group; systolic BP >90 mm Hg alone', 'RCT']","['major morbidity and mortality, and shorten hospital stay', 'episodes of atrial fibrillation', 'morbidity and mortality', 'major morbidity and mortality', 'respiratory failure', 'incidence of death or major complications (reoperation for bleeding, anastomotic leakage, pneumonia, reintubation, >48 h ventilation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C1271494', 'cui_str': 'Goal directed therapy'}, {'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C4518814', 'cui_str': 'Stroke volume variation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",232.0,0.492345,"After surgery, major morbidity and mortality were less frequent in 22/115 (19.1%) subjects randomised to GDT, compared with 41/117 (35.0%) subjects assigned to the control group {absolute risk reduction: 15.9% (95% confidence interval [CI]: 4.7-27.2%); P=0.006}. GDT was also associated with fewer episodes of atrial fibrillation (odds ratio [OR]: 0.18 [95% CI: 0.05-0.65]), respiratory failure (OR: 0.27 [95% CI: 0.09-0.83]), use of mini-tracheotomy (OR: 0.29 [95% CI: 0.10-0.81]), and readmission to ICU (OR: 0.09","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Mukai', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Suehiro', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan. Electronic address: suehirokoichi@yahoo.co.jp.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anaesthesiology, Osaka City General Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Juri', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Yasue', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Department of Anaesthesiology, Sumitomo Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Katsuaki', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiovascular Anaesthesiology, Osaka Rosai Hospital, Sakai City, Osaka, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Ohira', 'Affiliation': 'Department of Anaesthesiology, Sumitomo Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Anaesthesiology, Osaka City Juso Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Okutani', 'Affiliation': 'Department of Anaesthesiology, Osaka City General Hospital, Osaka City, Osaka, Japan.'}, {'ForeName': 'Kiyonobu', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Anaesthesiology, Osaka City University Graduate School of Medicine, Osaka City, Osaka, Japan.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.08.060']
1274,33094682,Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis.,"Aim: Evaluate safety/efficacy of intravenous meloxicam in a colorectal enhanced recovery after surgery protocol. Methods: Adults undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis received meloxicam IV 30 mg (n = 27) or placebo (n = 28) once daily beginning 30 min before surgery. Results: Adverse events: meloxicam IV, 85%; placebo, 93%. Adverse events commonly associated with opioids: 41 versus 61% - including nausea (33 vs 50%), vomiting (19 vs 18%) and ileus (4 vs 18%). Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups. No anastomotic leaks were reported. Opioid consumption, postoperative pain intensity, length of stay and times to first bowel sound, first flatus and first bowel movement were significantly lower with meloxicam IV versus placebo. Most subjects (>92%) were satisfied with postoperative pain medication. Conclusion: Meloxicam IV was generally well tolerated and associated with decreased opioid consumption, lower resource utilization and functional benefits. Clinical Trial Registration: NCT03323385 (ClinicalTrials.gov).",2021,"Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups.","['55 patients undergoing primary open or', 'Adults undergoing primary open or']","['meloxicam IV 30\xa0mg (n\xa0=\xa027) or placebo', 'meloxicam', 'laparoscopic colorectal surgery with bowel resection', 'opioids', 'laparoscopic colorectal surgery with bowel resection and/or anastomosis', 'placebo', 'Meloxicam IV', 'meloxicam IV versus placebo']","['Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs', 'anastomotic leaks', 'ileus', 'nausea', 'Opioid consumption, postoperative pain intensity, length of stay and times to first bowel sound, first flatus and first bowel movement', 'postoperative pain medication', 'tolerated and associated with decreased opioid consumption, lower resource utilization and functional benefits', 'vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0741614', 'cui_str': 'Bowel resection'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232693', 'cui_str': 'Bowel sounds'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",,0.285892,"Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups.","[{'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Silinsky', 'Affiliation': 'Department of Surgery, Tulane University, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'Department of Surgery, Tampa General Hospital, Tampa, FL, 33606, USA.'}, {'ForeName': 'Vamshi Ruthwik', 'Initials': 'VR', 'LastName': 'Anupindi', 'Affiliation': 'IQVIA, Falls Church, VA, 22042, USA.'}, {'ForeName': 'Swapna U', 'Initials': 'SU', 'LastName': 'Karkare', 'Affiliation': 'IQVIA, Falls Church, VA, 22042, USA.'}, {'ForeName': 'Drishti R', 'Initials': 'DR', 'LastName': 'Shah', 'Affiliation': 'IQVIA, Falls Church, VA, 22042, USA.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Mack', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'McCallum', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Clinical Statistics Consulting, Blue Bell, PA, 19422, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Freyer', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}, {'ForeName': 'Libby K', 'Initials': 'LK', 'LastName': 'Black', 'Affiliation': 'Baudax Bio\xa0Inc., Malvern, PA, 19355, USA.'}]",Pain management,['10.2217/pmt-2020-0061']
1275,33118638,"Predictors of treatment response durability in psychotherapy for binge-eating disorder: Examining the roles of self-discrepancy, self-directed style, and emotion dysregulation.","OBJECTIVE
To examine changes in hypothesized maintenance mechanisms during treatment as predictors of treatment response durability in binge-eating disorder (BED) treatment, using data from a randomized clinical trial comparing the efficacy of Integrative Cognitive-Affective Therapy for BED with cognitive-behavioral therapy delivered using guided self-help.
METHOD
Adults with BED (N = 112) received 17 weeks of treatment. Regression models were conducted to examine the extent to which changes in hypothesized maintenance mechanisms from baseline to end of treatment predicted treatment outcomes at 6-month follow-up, adjusting for demographics, study site, and baseline level of treatment outcome.
RESULTS
During-treatment reductions in negative self-directed style and emotion dysregulation predicted reductions in the primary treatment outcome (i.e., binge-eating episode frequency) at follow-up. During-treatment reductions in emotion dysregulation also predicted improvements at follow-up across all three secondary treatment outcomes examined (i.e., global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms), as did during-treatment reductions in actual-ideal self-discrepancy and actual-ought self-discrepancy. Increases in positive self-directed style (e.g., self-affirmation) and reductions in negative self-directed style (e.g., self-blame) during treatment each predicted improvements in anxiety symptoms at follow-up. When predictors were examined simultaneously, the most salient predictors of treatment response durability identified were negative self-directed style for binge-eating episode frequency, actual-ought self-discrepancy and emotion dysregulation for depressive symptoms, and emotion dysregulation for anxiety symptoms. No predictors emerged as most salient for global ED psychopathology.
DISCUSSION
Results indicate that negative self-directed style and emotion dysregulation are particularly important treatment targets in relation to behavioral treatment outcomes in BED.",2020,"During-treatment reductions in emotion dysregulation also predicted improvements at follow-up across all three secondary treatment outcomes examined (i.e., global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms), as did during-treatment reductions in actual-ideal self-discrepancy and actual-ought self-discrepancy.","['binge-eating disorder (BED', 'Adults with BED (N =\u2009112', 'binge-eating disorder']","['Integrative Cognitive-Affective Therapy for BED with cognitive-behavioral therapy delivered using guided self-help', 'psychotherapy']","['emotion dysregulation', 'global ED psychopathology', 'anxiety symptoms', 'global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms', 'negative self-directed style for binge-eating episode frequency, actual-ought self-discrepancy and emotion dysregulation for depressive symptoms, and emotion dysregulation for anxiety symptoms', 'positive self-directed style (e.g., self-affirmation) and reductions in negative self-directed style']","[{'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0199659,"During-treatment reductions in emotion dysregulation also predicted improvements at follow-up across all three secondary treatment outcomes examined (i.e., global eating disorder [ED] psychopathology, depressive symptoms, and anxiety symptoms), as did during-treatment reductions in actual-ideal self-discrepancy and actual-ought self-discrepancy.","[{'ForeName': 'Vivienne M', 'Initials': 'VM', 'LastName': 'Hazzard', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schaefer', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, California, Los Angeles, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota Medical School, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Sanford Center for Biobehavioral Research, Fargo, North Dakota, USA.'}]",The International journal of eating disorders,['10.1002/eat.23389']
1276,31777160,Left atrial structure and function and the risk of death or heart failure in atrial fibrillation.,"AIMS
The present study aimed to assess the association between left atrial (LA) structure and function and the risk for cardiovascular (CV) death or heart failure (HF) hospitalization in a population with atrial fibrillation (AF).
METHODS AND RESULTS
In a prospective echocardiographic substudy of the Effective Anticoagulation with Factor Xa Next Generation in AF-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) study, 971 patients underwent transthoracic echocardiography. The associations between LA structure (LA volume index [LAVi]) and function (LA emptying fraction [LAEF] and LA expansion index [LAEi]) and risk for the composite endpoint of CV death or HF hospitalization, and its components, were assessed. Over a median follow-up of 2.5 years, 142 patients (14.6%) experienced CV death or HF hospitalization. Higher LAVi and lower LAEF and LAEi were each associated with a higher unadjusted risk for the composite outcome and its components. After adjustment for clinical and echocardiographic confounders, only measures of impaired LA function were predictive of the composite outcome (hazard ratio [HR] per 1 standard deviation [SD] decrease in LAEF: 1.35; 95% confidence interval [CI] 1.09-1.67 [P = 0.005]; HR per 1 SD decrease in LAEi: 1.34; 95% CI 1.06-1.69 [P = 0.012]). These findings were similar regardless of left ventricular ejection fraction, history of HF or whether patients were in AF or sinus rhythm at the time of the echocardiographic examination.
CONCLUSIONS
In patients with AF, LA dysfunction was significantly associated with an increased risk for CV death or HF hospitalization and was more predictive of these outcomes than LA size. These parameters may help to identify AF patients at greatest risk for the development of HF.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT00781391.",2019,"These findings were similar regardless of left ventricular ejection fraction, history of HF or whether patients were in AF or sinus rhythm at the time of the echocardiographic examination.
","['971 patients underwent', 'population with atrial fibrillation (AF']","['transthoracic echocardiography', 'Factor Xa Next Generation']","['Left atrial structure and function and the risk of death or heart failure', 'impaired LA function', 'risk for CV death or HF hospitalization', 'CV death or HF hospitalization', 'LA structure (LA volume index [LAVi]) and function (LA emptying fraction [LAEF] and LA expansion index [LAEi]) and risk for the composite endpoint of CV death or HF hospitalization, and its components', 'left atrial (LA) structure and function and the risk for cardiovascular (CV) death or heart failure (HF) hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0015520', 'cui_str': 'Coagulation factor Xa'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0225860', 'cui_str': 'Left atrial structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0078994', 'cui_str': 'Atrial Function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",971.0,0.113759,"These findings were similar regardless of left ventricular ejection fraction, history of HF or whether patients were in AF or sinus rhythm at the time of the echocardiographic examination.
","[{'ForeName': 'Riccardo M', 'Initials': 'RM', 'LastName': 'Inciardi', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Gupta', 'Affiliation': 'Vanderbilt Translational and Clinical Cardiovascular Research Center, Division of Cardiovascular Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Michele F', 'Initials': 'MF', 'LastName': 'Mercuri', 'Affiliation': 'Cardiovascular, Metabolic and Renal Disease Therapeutic Area, Global Clinical Development, Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Cardiovascular, Metabolic and Renal Disease Therapeutic Area, Global Clinical Development, Daiichi Sankyo Pharma Development, Basking Ridge, NJ, USA.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1606']
1277,31807782,Effects of High-Intensity Laser Therapy on Pain Sensitivity and Motor Performance in Patients with Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial.,"OBJECTIVE
To examine the effects of high-intensity laser therapy (HILT) on pain sensitivity and motor performance in patients with thumb carpometacarpal (CMC) osteoarthritis (OA).
DESIGN
Prospective, triple-blinded, randomized, placebo-controlled trial.
SETTING
Private practice, Malaga, Spain.
SUBJECTS
Forty-three patients (mean ± SD age = 71 ± 12 years) with a diagnosis of thumb CMC OA grade 1-2 were randomized to the control group (N = 21) or experimental group (N = 22).
METHODS
The experimental group (ExpG) received high-intensity laser therapy (HILT), and the control group (ConG) received a placebo treatment. The outcome measures were pain intensity (visual analog scale) and key pinch strength measurements (dynamometer). All outcome measures were collected at baseline, immediately following the intervention, at four weeks, and at 12 weeks following the intervention.
RESULTS
Analysis of variance revealed a group × time interaction (F = 40.8, P < 0.001) for pain intensity, with those patients receiving LT experiencing a greater reduction in pain compared with those receiving placebo therapy at the end of the intervention (P < 0.001), as well as at 12 weeks after the intervention. Although mean values in the ExpG were higher than in the ConG for key pinch at assessment, these differences were not statistically significant.
CONCLUSIONS
HILT effectively diminishes pain intensity when used as an isolated treatment for patients with thumb CMC OA, but the effect of treatment decreases after 12 weeks.",2020,"RESULTS
Analysis of variance revealed a group × time interaction (F = 40.8, P < 0.001) for pain intensity, with those patients receiving LT experiencing a greater reduction in pain compared with those receiving placebo therapy at the end of the intervention (P < 0.001), as well as at 12 weeks after the intervention.","['Patients with Thumb Carpometacarpal Joint Osteoarthritis', 'patients with thumb carpometacarpal (CMC) osteoarthritis (OA', 'Private practice, Malaga, Spain', 'patients with thumb CMC OA', 'Forty-three patients (mean ± SD age = 71\u2009±\u200912\u2009years) with a diagnosis of thumb CMC OA grade 1-2']","['placebo treatment', 'high-intensity laser therapy (HILT', 'High-Intensity Laser Therapy', 'placebo', 'high-intensity laser therapy (HILT), and the control group (ConG']","['pain sensitivity and motor performance', 'pain intensity (visual analog scale) and key pinch strength measurements (dynamometer', 'Pain Sensitivity and Motor Performance', 'pain intensity', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0224620', 'cui_str': 'Carpometacarpal joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0429272', 'cui_str': 'Key pinch'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.225699,"RESULTS
Analysis of variance revealed a group × time interaction (F = 40.8, P < 0.001) for pain intensity, with those patients receiving LT experiencing a greater reduction in pain compared with those receiving placebo therapy at the end of the intervention (P < 0.001), as well as at 12 weeks after the intervention.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Cantero-Téllez', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Malaga, Malaga, Spain.'}, {'ForeName': 'Jorge Hugo', 'Initials': 'JH', 'LastName': 'Villafañe', 'Affiliation': 'Fondazione Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Valdes', 'Affiliation': 'Departament of Ocupational Therapy, Gannon University, Ruskin, FL, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'García-Orza', 'Affiliation': 'Hospital Comarcal de la Axarquia, Malaga, Spain.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Bishop', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Medina-Porqueres', 'Affiliation': 'Department of Physical Therapy, Faculty of Health Sciences, University of Malaga, Malaga, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz297']
1278,33125166,Comparative effectiveness of external vs blended facilitation on collaborative care model implementation in slow-implementer community practices.,"OBJECTIVE
To evaluate the comparative effectiveness of external facilitation (EF) vs external + internal facilitation (EF/IF), on uptake of a collaborative chronic care model (CCM) in community practices that were slower to implement under low-level implementation support.
STUDY SETTING
Primary data were collected from 43 community practices in Michigan and Colorado at baseline and for 12 months following randomization.
STUDY DESIGN
Sites that failed to meet a pre-established implementation benchmark after six months of low-level implementation support were randomized to add either EF or EF/IF support for up to 12 months. Key outcomes were change in number of patients receiving the CCM and number of patients receiving a clinically significant dose of the CCM. Moderators' analyses further examined whether comparative effectiveness was dependent on prerandomization adoption, number of providers trained or practice size. Facilitation log data were used for exploratory follow-up analyses.
DATA COLLECTION
Sites reported monthly on number of patients that had received the CCM. Facilitation logs were completed by study EF and site IFs and shared with the study team.
PRINCIPAL FINDINGS
N = 21 sites were randomized to EF and 22 to EF/IF. Overall, EF/IF practices saw more uptake than EF sites after 12 months (Δ EF/IF-EF = 4.4 patients, 95% CI = 1.87-6.87). Moderators' analyses, however, revealed that it was only sites with no prerandomization uptake of the CCM (nonadopter sites) that saw significantly more benefit from EF/IF (Δ EF/IF-EF = 9.2 patients, 95% CI: 5.72, 12.63). For sites with prerandomization uptake (adopter sites), EF/IF offered no additional benefit (Δ EF/IF-EF = -0.9; 95% CI: -4.40, 2.60). Number of providers trained and practice size were not significant moderators.
CONCLUSIONS
Although stepping up to the more intensive EF/IF did outperform EF overall, its benefit was limited to sites that failed to deliver any CCM under the low-level strategy. Once one or more providers were delivering the CCM, additional on-site personnel did not appear to add value to the implementation effort.",2020,"IF (Δ EF/IF-EF = 9.2 patients, 95% CI: 5.72, 12.63).","['slow-implementer community practices', 'Primary data were collected from 43 community practices in Michigan and Colorado at baseline and for 12\xa0months following randomization', 'N\xa0=\xa021 sites', 'Sites that failed to meet a pre-established implementation benchmark after six months of low-level implementation support']","['external facilitation (EF) vs external\xa0+\xa0internal facilitation (EF/IF', 'external vs blended facilitation']",[],"[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]",[],,0.0757305,"IF (Δ EF/IF-EF = 9.2 patients, 95% CI: 5.72, 12.63).","[{'ForeName': 'Shawna N', 'Initials': 'SN', 'LastName': 'Smith', 'Affiliation': 'Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Celeste M', 'Initials': 'CM', 'LastName': 'Liebrecht', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Bauer', 'Affiliation': 'Center for Healthcare Organization & Implementation Research, VA Boston Healthcare System, Boston, Massachusetts, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Kilbourne', 'Affiliation': 'Department of Learning Health Sciences, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",Health services research,['10.1111/1475-6773.13583']
1279,33239106,"Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial.","BACKGROUND
The management of acute febrile illnesses places a heavy burden on clinical services in many low- and middle-income countries (LMICs). Bacterial and viral aetiologies of acute fevers are often clinically indistinguishable and, in the absence of diagnostic tests, the 'just-in-case' use of antibiotics by many health workers has become common practice, which has an impact on drug-resistant infections. Our study aims to answer the following question: in patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs, can we demonstrate an improvement in clinical outcomes and reduce unnecessary antibiotic prescription over current practice by using a combination of simple, accurate diagnostic tests, clinical algorithms, and training and communication (intervention package)?
METHODS
We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses. Available, point-of-care, pathogen-specific and non-pathogen specific (host markers), rapid diagnostic tests (RDTs) included in the intervention package were selected based on pre-defined criteria. Nine clinical study sites in six countries (Burkina Faso, Ghana, India, Myanmar, Nepal and Uganda), which represent heterogeneous outpatient care settings, were selected. We considered the expected seasonal variations in the incidence of acute febrile illnesses across all the sites by ensuring a recruitment period of 12 months. A master protocol was developed and adapted for country-specific ethical submissions. Diagnostic algorithms and choice of RDTs acknowledged current data on aetiologies of acute febrile illnesses in each country. We included a qualitative evaluation of drivers and/or deterrents of uptake of new diagnostics and antibiotic use for acute febrile illnesses. Sample size estimations were based on historical site data of antibiotic prescription practices for malarial and non-malarial acute fevers. Overall, 9 semi-independent studies will enrol a minimum of 21,876 patients and an aggregate data meta-analysis will be conducted on completion.
DISCUSSION
This study is expected to generate vital evidence needed to inform policy decisions on the role of rapid diagnostic tests in the clinical management of acute febrile illnesses, with a view to controlling the rise of antimicrobial resistance in LMICs.
TRIAL REGISTRATION
Clinicaltrials.gov NCT04081051 . Registered on 6 September 2019. Protocol version 1.4 dated 20 December 2019.",2020,"We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses.","['outpatient acute fever case management in low- and middle-income countries', 'acute febrile illnesses', 'patients with undifferentiated febrile illness presenting to outpatient clinics/peripheral health centres in LMICs']","['intervention package', 'package of diagnostic tools, clinical algorithm, and training and communication']",['clinical outcomes and antibiotic prescription rates'],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0743842', 'cui_str': 'Acute febrile illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205618', 'cui_str': 'Undifferentiated'}, {'cui': 'C0743841', 'cui_str': 'Disorder characterized by fever'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0475309', 'cui_str': 'Health center'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",,0.186787,"We designed a randomized, controlled clinical trial to evaluate the impact of our intervention package on clinical outcomes and antibiotic prescription rates in acute febrile illnesses.","[{'ForeName': 'Olawale', 'Initials': 'O', 'LastName': 'Salami', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND) Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Horgan', 'Affiliation': 'Big Data Institute, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Catrin E', 'Initials': 'CE', 'LastName': 'Moore', 'Affiliation': 'Big Data Institute, University of Oxford, Old Road Campus, Oxford, OX3 7LF, UK.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Giri', 'Affiliation': 'Oxford University Clinical Research Unit (OUCRU-Nepal), Patan Hospital, Lalitpur, Nepal.'}, {'ForeName': 'Asadu', 'Initials': 'A', 'LastName': 'Sserwanga', 'Affiliation': 'Infectious Diseases Research Collaboration (IDRC), Nakasero Hill Rd, Kampala, Uganda.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Pathak', 'Affiliation': 'RD Gardi Medical College, Ujjain, Madhya Pradesh, 456001, India.'}, {'ForeName': 'Buddha', 'Initials': 'B', 'LastName': 'Basnyat', 'Affiliation': 'Oxford University Clinical Research Unit (OUCRU-Nepal), Patan Hospital, Lalitpur, Nepal.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Kiemde', 'Affiliation': 'Institut de Recherche en Sciences de la Santé Clinical Research Unit of Nanoro (IRSS-URCN), Nanoro, Burkina Faso.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Myanmar Oxford Clinical Research Unit (MOCRU), Yangon, Myanmar.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Kitutu', 'Affiliation': 'Department of Pharmacy, School of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Gajanan', 'Initials': 'G', 'LastName': 'Phutke', 'Affiliation': 'Jan Swasthya Sahyog, Ganiyari, India.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé Clinical Research Unit of Nanoro (IRSS-URCN), Nanoro, Burkina Faso.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Hopkins', 'Affiliation': 'London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kapisi', 'Affiliation': 'Infectious Diseases Research Collaboration (IDRC), Nakasero Hill Rd, Kampala, Uganda.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Myanmar Oxford Clinical Research Unit (MOCRU), Yangon, Myanmar.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Taneja', 'Affiliation': 'Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Baiden', 'Affiliation': 'Dodowa Health Research Centre, P.O. Box DD1, Dodowa, Ghana.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'National Institute of Cholera and Enteric Diseases (NICED), Kolkata, India.'}, {'ForeName': 'Adelaide', 'Initials': 'A', 'LastName': 'Compaore', 'Affiliation': 'London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, London, WC1E 7HT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaawa-Mafigiri', 'Affiliation': 'School of Social Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Rashida', 'Initials': 'R', 'LastName': 'Hussein', 'Affiliation': 'Myanmar Oxford Clinical Research Unit (MOCRU), Yangon, Myanmar.'}, {'ForeName': 'Summita Udas', 'Initials': 'SU', 'LastName': 'Shakya', 'Affiliation': 'Oxford University Clinical Research Unit (OUCRU-Nepal), Patan Hospital, Lalitpur, Nepal.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Kukula', 'Affiliation': 'Dodowa Health Research Centre, P.O.Box DD1, Dodowa, Ghana.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ongarello', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND) Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Tomar', 'Affiliation': 'FIND India, 9th Floor, Vijaya Building, 17, Barakhamba Road, New Delhi, 110001, India.'}, {'ForeName': 'Sarabjit S', 'Initials': 'SS', 'LastName': 'Chadha', 'Affiliation': 'FIND India, 9th Floor, Vijaya Building, 17, Barakhamba Road, New Delhi, 110001, India.'}, {'ForeName': 'Kamini', 'Initials': 'K', 'LastName': 'Walia', 'Affiliation': 'Indian Council of Medical Research, Division of Epidemiology and Communicable Diseases, Indian Council of Medical Research, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Kelly-Cirino', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND) Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Olliaro', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND) Campus Biotech, Chemin des Mines 9, 1202, Geneva, Switzerland. piero.olliaro@finddx.org.'}]",Trials,['10.1186/s13063-020-04897-9']
1280,33075100,Fitbit wear-time and patterns of activity in cancer survivors throughout a physical activity intervention and follow-up: Exploratory analysis from a randomised controlled trial.,"OBJECTIVE
There has been growing interest in the use of smart wearable technology to promote physical activity (PA) behaviour change. However, little is known concerning PA patterns throughout an intervention or engagement with trackers. The objective of the study was to explore patterns of Fitbit-measured PA and wear-time over 24-weeks and their relationship to changes in Actigraph-derived moderate-to-vigorous PA (MVPA).
METHODS
Twenty-nine intervention participants (88%) from the wearable activity technology and action-planning (WATAAP) trial in colorectal and endometrial cancer survivors accepted a Fitbit friend request from the research team to permit monitoring of Fitbit activity. Daily steps and active minutes were recorded for each participant over the 12-week intervention and throughout the follow-up period to 24-weeks. Accelerometer (GT9X) derived MVPA was assessed at end of intervention (12-weeks) and end of follow-up (24-weeks).
RESULTS
Fitbit wear-time over the 24-weeks of data was remarkably consistent, with median adherence score of 100% for all weeks. During the intervention, participants recorded a median 8006 steps/day. Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039). Actigraph and Fitbit derived measures were highly correlated but demonstrated poor agreement overall. Fitbit measured activity was closest to MVPA measured using Freedson cut-points as no bias was observed.
CONCLUSIONS
Step count was maintained throughout the trial displaying promise for the effectiveness of smart-wearable interventions to reduce sedentary behaviour beyond the intervention period. Further worthwhile work should compare more advanced smart-wearable technology with accelerometers in order to improve agreement and explore less resource-intensive methods to assess PA that could be scalable.",2020,Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039).,"['Twenty-nine intervention participants (88%) from the', 'cancer survivors', 'in colorectal and endometrial cancer survivors']","['physical activity intervention', 'wearable activity technology and action-planning (WATAAP) trial']","['median adherence score', 'Daily step count']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.051742,Daily step count was slightly increased through week-13 to week-24 with a median of 8191 steps/day (p = 0.039).,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Hardcastle', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Jiménez-Castuera', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, Cáceres, Spain.'}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Maxwell-Smith', 'Affiliation': 'School of Psychology, Curtin University, Bentley, Perth, Western Australia, Australia.'}, {'ForeName': 'Max K', 'Initials': 'MK', 'LastName': 'Bulsara', 'Affiliation': 'Institute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Hince', 'Affiliation': 'Institute for Health Research, University of Notre Dame, Fremantle, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0240967']
1281,33239406,Moving singing for lung health online in response to COVID-19: experience from a randomised controlled trial.,"INTRODUCTION
Singing for lung health (SLH) is a popular arts-in-health activity for people with long-term respiratory conditions. Participants report biopsychosocial benefits, however, research on impact is limited. The 'SLH: Improving Experiences of Lung Disease trial', a randomised controlled, single (assessor) blind, trial of 12 weeks SLH versus usual care for people with chronic obstructive pulmonary disease (COPD) (n=120) was setup to help to address this. The first group (n=18, nine singing and nine controls) started face-to-face (five sessions) before changing to online delivery (seven sessions) due to COVID-19-related physical distancing measures. As such, the experience of this group is here reported as a pilot study to inform further research in this area.
METHODS
We conducted semistructured interviews and thematic analysis regarding barriers, facilitators and key considerations for transitioning from face-to-face to online delivery. Pilot quantitative outcomes include attendance, premeasures and postmeasures of quality of life and disease impact (Short Form 36 Health Survey, COPD Assessment Test score), breathlessness (Medical Research Council breathlessness scale, Dyspnoea-12), depression (Patient Health Questionnaire-9, PHQ-9), anxiety (Generalised Anxiety Disorder-7), balance confidence (Activity specific Balance Confidence, ABC scale) and physical activity (clinical visit PROactive physical activity in COPD tool, combining subjective rating and actigraphy).
RESULTS
Attendance was 69% overall, (90% of the face-to-face sessions, 53% online sessions). Analysis of semistructured interviews identified three themes regarding participation in SLH delivered face to face and online, these where (1) perceived benefits; (2) digital barriers (online) and (3) digital facilitators (online). Findings were summarised into key considerations for optimising transitioning singing groups from face-to-face to online delivery. Pilot quantitative data suggested possible improvements in depression (treatment effect -4.78 PHQ-9 points, p<0.05, MCID 5) and balance confidence (treatment effect +17.21 ABC scale points, p=0.04, MCID 14.2).
DISCUSSION
This study identifies key considerations regarding the adaptation of SLH from face-to-face to online delivery. Pilot data suggest online group singing for people with COPD may deliver benefits related to reducing depression and improved balance confidence.",2020,"Pilot quantitative data suggested possible improvements in depression (treatment effect -4.78 PHQ-9 points, p<0.05, MCID 5) and balance confidence (treatment effect +17.21 ABC scale points, p=0.04, MCID 14.2).
","['people with COPD', 'people with chronic obstructive pulmonary disease (COPD) (n=120', 'people with long-term respiratory conditions']","['Singing for lung health (SLH', 'SLH versus usual care', 'Moving singing', 'SLH']","['depression', 'balance confidence', 'attendance, premeasures and postmeasures of quality of life and disease impact (Short Form 36 Health Survey, COPD Assessment Test score), breathlessness (Medical Research Council breathlessness scale, Dyspnoea-12), depression (Patient Health Questionnaire-9, PHQ-9), anxiety (Generalised Anxiety Disorder-7), balance confidence (Activity specific Balance Confidence, ABC scale) and physical activity (clinical visit PROactive physical activity in COPD tool, combining subjective rating and actigraphy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0578671', 'cui_str': 'Does move'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2960692', 'cui_str': 'Chronic obstructive pulmonary disease assessment test score'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",,0.0586631,"Pilot quantitative data suggested possible improvements in depression (treatment effect -4.78 PHQ-9 points, p<0.05, MCID 5) and balance confidence (treatment effect +17.21 ABC scale points, p=0.04, MCID 14.2).
","[{'ForeName': 'Keir Ej', 'Initials': 'KE', 'LastName': 'Philip', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK k.philip@imperial.ac.uk.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Brunel University London, London, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Jeffery', 'Affiliation': 'Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Buttery', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Phoene', 'Initials': 'P', 'LastName': 'Cave', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Cristiano', 'Affiliation': 'Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lound', 'Affiliation': 'Respiratory Medicine, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': 'Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'William D-C', 'Initials': 'WD', 'LastName': 'Man', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Fancourt', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Polkey', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000737']
1282,33086238,"A 3-way Cross-over Study of Pregabalin, Placebo, and the Histamine 3 Receptor Inverse Agonist AZD5213 in Combination With Pregabalin in Patients With Painful Diabetic Neuropathy and Good Pain-reporting Ability.","OBJECTIVES
In this study, patients with painful diabetic neuropathy were trained using an experimental pain paradigm in an attempt to enroll a subset of patients who are ""pain connoisseurs"" and therefore more able to discriminate between active and placebo treatments.
METHODS
AZD5213, a novel histamine H3 receptor inverse agonist+pregabalin, pregabalin, and placebo were then tested in a 3-period cross-over.
RESULTS
The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of painful diabetic neuropathy.
DISCUSSION
The training of study patients in pain reporting and subsequent enrichment with good pain reporters also did not enable the robust detection of the efficacy of pregabalin relative to placebo in a small sample size. Further work is required before recommending the use of ""connoisseur"" patients in future neuropathic pain studies.",2021,"The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of PDN.
","['Subjects with Painful Diabetic Neuropathy and Good Pain-Reporting Ability', 'patients with painful diabetic neuropathy (PDN']","['experimental pain paradigm', 'pregabalin, pregabalin and placebo', 'Pregabalin, Placebo', 'pregabalin', 'placebo', 'Pregabalin', 'AZD5213']",[],"[{'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0859344,"The study did not provide any evidence of clinical efficacy for AZD5213 when combined with pregabalin in the treatment of PDN.
","[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Alexander', 'Affiliation': 'Takeda Pharmaceuticals International Co., Cambridge.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Raudibaugh', 'Affiliation': 'Acadia Pharmaceuticals, Princeton, NJ.'}, {'ForeName': 'Egilius L H', 'Initials': 'ELH', 'LastName': 'Spierings', 'Affiliation': 'MedVadis Research Corporation, Waltham.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'WCG Analgesic Solutions, Wayland.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000886']
1283,33086239,Greater Conditioned Pain Modulation Is Associated With Enhanced Morphine Analgesia in Healthy Individuals and Patients With Chronic Low Back Pain.,"OBJECTIVES
Conditioned pain modulation (CPM) protocols index magnitude of descending pain inhibition. This study evaluated whether the degree of CPM, controlling for CPM expectancy confounds, was associated with analgesic and subjective responses to morphine and whether chronic pain status or sex moderated these effects.
MATERIALS AND METHODS
Participants included 92 individuals with chronic low back pain and 99 healthy controls, none using daily opioid analgesics. In a cross-over design, participants attended 2 identical laboratory sessions during which they received either intravenous morphine (0.08 mg/kg) or saline placebo before undergoing evoked pain assessment. In each session, participants engaged in ischemic forearm and heat pain tasks, and a CPM protocol combining ischemic pain (conditioning stimulus) and heat pain (test stimulus). Placebo-controlled morphine outcomes were derived as differences in pain and subjective effects across drug conditions.
RESULTS
In hierarchical regressions controlling for CPM expectancies, greater placebo-condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (Visual Analog Scale Pain Intensity and Unpleasantness) and heat pain task (Visual Analog Scale Pain Intensity, McGill Pain Questionnaire-Sensory, and Present Pain Intensity subscales). There was no moderation by sex or chronic low back pain status, except for the ischemic Present Pain Intensity outcome for which a significant 2-way interaction (P<0.05) was noted, with men showing a stronger positive relationship between CPM and morphine analgesia than women.
DISCUSSION
Results suggest that CPM might predict analgesic and subjective responses to opioid administration. Further evaluation of CPM as an element of precision pain medicine algorithms may be warranted.",2021,"In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales).","['Healthy Individuals and Patients with Chronic Low Back Pain', 'Participants included 92 individuals with chronic low back pain (CLBP) and 99 healthy controls, none using daily opioid analgesics']","['saline placebo', 'intravenous morphine', 'Placebo-controlled morphine', 'morphine', 'CPM protocol combining ischemic pain (conditioning stimulus) and heat pain (test stimulus', 'Morphine Analgesia']","['pain and subjective effects', 'subjective morphine unpleasantness', 'ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales', 'ischemic PPI outcome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445114', 'cui_str': 'None used'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",92.0,0.20887,"In hierarchical regressions controlling for CPM expectancies, greater placebo condition CPM was associated with less subjective morphine unpleasantness (P=0.001) and greater morphine analgesia (P's<0.05) on both the ischemic pain task (VAS Pain Intensity and Unpleasantness) and heat pain task (VAS Pain Intensity, McGill Pain Questionnaire-Sensory and Present Pain Intensity [PPI] subscales).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bruehl', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Stone', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Asokumar', 'Initials': 'A', 'LastName': 'Buvanendran', 'Affiliation': 'Departments of Anesthesiology.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chont', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Behavioral Science, Rush University, Chicago, IL.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000887']
1284,33091102,Screening for expired medications in automated dispensing cabinets.,"PURPOSE
Results of a study to quantify rates of identification of expired medications in automated dispensing cabinets (ADCs) are reported.
METHODS
A pre-post analysis was conducted to determine the effect of various types of ADC audits on rates of finding expired medications in ADCs. For the experimental phase of the study, 4 ADCs at the main campus of an academic medical center were randomly assigned to receive one of 4 interventions: (1) monthly audits of all ADC pockets, (2) monthly audits of matrix (open pocket) drawers only, (3) monthly audits of unassigned pockets only, and (4) no additional intervention.
RESULTS
At baseline, rates of finding expired medication doses in the 4 ADCs ranged from 0.4% to 0.7%. During the 3-month experimental period, rates of finding expired medication doses ranged from 0.1% to 0.3%. During a final audit 1 month later, the ADC targeted for monthly audits of all pockets was found to contain no expired doses, with an overall improvement in expired-dose rates for all audited ADCs observed over the course of the 4-month study. The average time to perform a full audit for an ADC with about 340 pockets was 1 hour, or 15 seconds per pocket. The average time to perform matrix drawer-only audits averaged around 45 minutes, or 11 seconds per pocket. The average time to perform audits of unassigned matrix drawers averaged 30 minutes, or 10 seconds per pocket.
CONCLUSION
Auditing of all ADC pockets on a monthly basis appears to be an effective method of reducing the rate of identification of expired medications in ADC pockets.",2020,"The average time to perform audits of unassigned matrix drawers averaged 30 minutes, or 10 seconds per pocket.
",['4 ADCs at the main campus of an academic medical center'],"['matrix (open pocket) drawers only, (3) monthly audits of unassigned pockets only, and (4) no additional intervention']",['rates of finding expired medication doses'],"[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0179481', 'cui_str': 'Cabinet'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0453897', 'cui_str': 'Drawers'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0354343,"The average time to perform audits of unassigned matrix drawers averaged 30 minutes, or 10 seconds per pocket.
","[{'ForeName': 'Alexis N', 'Initials': 'AN', 'LastName': 'Nanni', 'Affiliation': 'University of North Carolina Medical Center, Chapel Hill, NC.'}, {'ForeName': 'Trusha S', 'Initials': 'TS', 'LastName': 'Rana', 'Affiliation': 'University of North Carolina Medical Center, Chapel Hill, NC.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Schenkat', 'Affiliation': 'University of North Carolina Medical Center, Chapel Hill, NC.'}]",American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists,['10.1093/ajhp/zxaa318']
1285,33094860,The open versus blind weight conundrum: A multisite randomized controlled trial across multiple levels of patient care for anorexia nervosa.,"OBJECTIVE
Anorexia nervosa (AN) is a disorder characterized by a profound fear of weight gain, resulting in significant weight loss, as well as behavioral symptoms that interfere with weight normalization. In concert, weight gain remains a proximal goal of treatment, and patient weighing is a critical component of treatment. However, divergent approaches exist in how patient weighing is undertaken in clinical practice. The aim of this study is to investigate the impact of a brief course of open weighing (sharing weight data with patients) versus blind weighing (not sharing weight data with patients) on distress around being weighed and AN symptom severity.
METHOD
216 patients with AN and atypical AN will be randomized to receive 4 weeks of open or blind weighing practices across residential, intensive outpatient, and outpatient treatment settings, within the context of manualized empirically supported treatment. Following 4 weeks of open or blind weighing, all patients will be enrolled into open weighing practices. Primary outcomes of interest will be patient-reported distress around being weighed at week 5 and eating disorder symptom severity at week 5. Secondary outcomes will assess weight prediction error, intolerance of uncertainty, and the fear of food.
DISCUSSION
No best practice guidelines exist in determining optimal practices around weighing patients with AN. This multisite randomized controlled trial will provide the first known data on the impact of open versus blind weighing practices upon weight-related distress and AN symptom severity.",2020,Primary outcomes of interest will be patient-reported distress around being weighed at week 5 and eating disorder symptom severity at week 5.,"['patient care for anorexia nervosa', '216 patients with AN and atypical AN']",[],"['patient-reported distress around being weighed at week 5 and eating disorder symptom severity', 'weight prediction error, intolerance of uncertainty, and the fear of food']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0338959', 'cui_str': 'Atypical anorexia nervosa'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",216.0,0.119373,Primary outcomes of interest will be patient-reported distress around being weighed at week 5 and eating disorder symptom severity at week 5.,"[{'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Cheri A', 'Initials': 'CA', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychological and Brain Sciences, University of Louisville, Louisville, Kentucky, USA.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Farrell', 'Affiliation': 'Rogers Behavioral Health, Oconomowoc, Wisconsin, USA.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Nagata', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Emilio J', 'Initials': 'EJ', 'LastName': 'Compte', 'Affiliation': 'School of Psychology, Universidad Adolfo Ibáñez, Santiago, Chile.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}]",The International journal of eating disorders,['10.1002/eat.23397']
1286,33096332,"The role of expressive suppression and cognitive reappraisal in cognitive behavioral therapy for social anxiety disorder: A study of self-report, subjective, and electrocortical measures.","BACKGROUND
Contemporary models of cognitive behavioral therapy (CBT) for social anxiety disorder (SAD) emphasize emotion dysregulation as a core impairment whose reduction may play a causal role in psychotherapy. The current study examined changes in use of emotion regulation strategies as possible mechanisms of change in CBT for SAD. Specifically, we examined changes in expressive suppression and cognitive reappraisal during CBT and whether these changes predict treatment outcome.
METHODS
Patients (n = 34; 13 females; Mean age = 28.36 (6.97)) were allocated to 16-20 sessions of CBT. An electrocortical measure of emotion regulation and a clinician-rated measure of SAD were administered monthly. Self-report measures of emotion regulation and social anxiety were administered weekly. Multilevel models were used to examine changes in emotion regulation during treatment and cross-lagged associations between emotion regulation and anxiety.
RESULTS
CBT led to decreased suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures (ps < .05). At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli. Gains were maintained at 3-months follow-up. Decreases in suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety but not the other way around (ps < .05). Lower anxiety predicted greater subsequent increases in reappraisal self-efficacy.
LIMITATIONS
The lack of a control group precludes conclusions regarding mechanisms specificity.
CONCLUSIONS
Decreased frequency of suppression is a potential mechanism of change in CBT for SAD.",2020,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","['Patients (n\xa0', 'social anxiety disorder', '34; 13 females; Mean age\xa0=\xa028.36 (6.97']","['cognitive behavioral therapy (CBT', 'expressive suppression and cognitive reappraisal in cognitive behavioral therapy']","['emotion regulation', 'emotion regulation and social anxiety', 'suppression frequency and electrocortical reactivity to SAD-related pictures predicted lower subsequent anxiety', 'suppression frequency, increased reappraisal self-efficacy, and decreased unpleasantness for SAD-related pictures', 'expressive suppression and cognitive reappraisal', 'reappraisal self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0112977,"At post-treatment, patients were equivalent to healthy controls in terms of suppression frequency and subjective reactivity to SAD-related stimuli.","[{'ForeName': 'Yogev', 'Initials': 'Y', 'LastName': 'Kivity', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: yogev.kivity@biu.ac.il.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Elizur', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.021']
1287,33098856,"Oral once-daily berotralstat for the prevention of hereditary angioedema attacks: A randomized, double-blind, placebo-controlled phase 3 trial.","BACKGROUND
Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein in development for the prophylaxis of hereditary angioedema (HAE) attacks.
OBJECTIVE
Our aim was to determine the efficacy, safety, and tolerability of berotralstat in patients with HAE over a 24-week treatment period (the phase 3 APeX-2 trial).
METHODS
APeX-2 was a double-blind, parallel-group study that randomized patients at 40 sites in 11 countries 1:1:1 to receive once-daily berotralstat in a dose of 110 mg or 150 mg or placebo (Clinicaltrials.gov identifier NCT03485911). Patients aged 12 years or older with HAE due to C1 inhibitor deficiency and at least 2 investigator-confirmed HAE attacks in the first 56 days of a prospective run-in period were eligible. The primary efficacy end point was the rate of investigator-confirmed HAE attacks during the 24-week treatment period.
RESULTS
A total of 121 patients were randomized; 120 of them received at least 1 dose of the study drug (n = 41, 40, and 39 in the 110-mg dose of berotralstat, 150-mg of dose berotralstat, and placebo groups, respectively). Berotralstat demonstrated a significant reduction in attack rate at both 110 mg (1.65 attacks per month; P = .024) and 150 mg (1.31 attacks per month; P < .001) relative to placebo (2.35 attacks per month). The most frequent treatment-emergent adverse events that occurred more with berotralstat than with placebo were abdominal pain, vomiting, diarrhea, and back pain. No drug-related serious treatment-emergent adverse events occurred.
CONCLUSION
Both the 110-mg and 150-mg doses of berotralstat reduced HAE attack rates compared with placebo and were safe and generally well tolerated. The most favorable benefit-to-risk profile was observed at a dose of 150 mg per day.",2020,Both the 110-mg and 150-mg doses of berotralstat reduced HAE attack rates compared with placebo and were safe and generally well tolerated.,"['hereditary angioedema attacks', 'Patients aged ≥12 years with HAE due to C1 inhibitor deficiency and ≥2 investigator-confirmed HAE attacks in the first 56 days of a prospective run-in period were eligible', 'One-hundred twenty-one patients', 'patients with HAE over a 24-week treatment period (the phase 3 APeX-2 trial']","['Berotralstat (BCX7353', 'placebo']","['efficacy, safety, and tolerability of berotralstat', 'abdominal pain, vomiting, diarrhea, and back pain', 'HAE attack rates', 'rate of investigator-confirmed HAE attacks', 'attack rate', 'tolerated']","[{'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C3854637', 'cui_str': 'Hereditary angioedema attack'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]",121.0,0.513008,Both the 110-mg and 150-mg doses of berotralstat reduced HAE attack rates compared with placebo and were safe and generally well tolerated.,"[{'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Zuraw', 'Affiliation': 'University of California San Diego, San Diego, Calif.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy & Asthma Specialists of Dallas, Dallas, Tex.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Johnston', 'Affiliation': 'Asthma and Allergy Specialists, Charlotte, NC.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Aygören-Pürsün', 'Affiliation': 'University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Christiansen', 'Affiliation': 'University of California San Diego, San Diego, Calif.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Jacobs', 'Affiliation': 'Allergy and Asthma Clinical Research, Walnut Creek, Calif.'}, {'ForeName': 'Karl V', 'Initials': 'KV', 'LastName': 'Sitz', 'Affiliation': 'Little Rock Allergy and Asthma Clinical Research Center, Little Rock, Ark.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Gower', 'Affiliation': 'University of Washington School of Medicine, Marycliff Clinical Research, Spokane, Wash.'}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': 'Clinique Spécialisée en Allergie de la Capitale, Québec, Canada.'}, {'ForeName': 'H James', 'Initials': 'HJ', 'LastName': 'Wedner', 'Affiliation': 'Washington University School of Medicine, St Louis, Mo.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kinaciyan', 'Affiliation': 'Medical University of Vienna, Department of Dermatology, Vienna, Austria.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hakl', 'Affiliation': ""Department of Clinical Immunology and Allergology, St. Anne's University Hospital in Brno and Faculty of Medicine, Masaryk University, Brno, Czech Republic.""}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hanzlíková', 'Affiliation': 'Faculty Hospital, Department of Allergology and Immunology, Plzen, Czech Republic.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Anderson', 'Affiliation': 'Clinical Research Center of Alabama, Birmingham, Ala.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'McNeil', 'Affiliation': 'Optimed Research Ltd, Columbus, Ohio.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Fritz', 'Affiliation': 'Portland Clinical Research, Portland, Ore.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Tachdjian', 'Affiliation': 'Department of Pediatrics, University of California, Los Angeles, Calif.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Busse', 'Affiliation': 'Division of Clinical Immunology and Allergy, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Craig', 'Affiliation': 'Department of Medicine and Pediatrics, Penn State University, Hershey, Pa.'}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, Chevy Chase, Md.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Third Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Best', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Clemons', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Cornpropst', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'Dobo', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Iocca', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Kargl', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Eniko', 'Initials': 'E', 'LastName': 'Nagy', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Sharon C', 'Initials': 'SC', 'LastName': 'Murray', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Collis', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Sheridan', 'Affiliation': 'BioCryst Pharmaceuticals, Durham, NC. Electronic address: bsheridan@biocryst.com.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Department of Dermatology and Allergy, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California San Diego, San Diego, Calif.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.10.015']
1288,33098862,Management of Bladder Bowel Dysfunction in Children by Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises: A Randomized Clinical Trial.,,2020,,['Children by'],['Pelvic Floor Interferential Electrical Stimulation and Muscle Exercises'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",[],,0.0429551,,"[{'ForeName': 'Vesna D', 'Initials': 'VD', 'LastName': 'Zivkovic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia. Electronic address: petvesna67@gmail.com.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Stankovic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia.'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Dimitrijevic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia.'}, {'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Zlatanovic', 'Affiliation': 'Clinic of Physical Medicine and Rehabilitation, Clinical Centre Nis, University of Nis Faculty of Medicine, Nis, Serbia.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Savic', 'Affiliation': 'College of Health Studies Cuprija, Cuprija, Serbia.'}]",Urology,['10.1016/j.urology.2020.10.012']
1289,33098889,Postobturation Pain Associated with Tricalcium Silicate and Resin-based Sealer Techniques: A Randomized Clinical Trial.,"INTRODUCTION
The incidence of immediate postobturation pain associated with 2 sealer techniques was compared and potential prognostic factors identified.
METHODS
Patients referred for endodontic treatment were recruited with informed consent. Root canals were debrided and teeth rendered asymptomatic before random allocation to receive TotalFill BC (FKG Dentaire SA, La Chaux-de-Fonds, Switzerland) or AH Plus sealer (Dentsply Maillefer, Ballaigues, Switzerland). Patients blinded to the sealer reported their postobturation pain experience 1, 3, and 7 days after treatment. Blinded and calibrated assessors independently reviewed treatment quality, sealer extrusion, and radiographic data under standardized conditions.
RESULTS
One hundred sixty eligible patients (163 teeth, 95.3%) returned their pain diary. No postobturation pain difference was found between the 2 sealers (P > .05), although the AH Plus sealer technique was significantly associated with extrusion beyond the apex (P < .05; odds ratio [OR] = 3.02; 95% confidence interval [CI], 1.39-6.57). Thirty-three (20.6%) patients reported pain on day 1 (median 1 = very mild pain), 16 (10.0%) on day 3 (median 1 = very mild pain), and 9 (5.6%) on day 7 (median 2 = mild pain). The prognostic factors were as follows: (1) moderate/severe preoperative pain (OR = 4.41; 95% CI, 1.42-13.76 on day 3 and OR = 5.16; 95% CI, 1.17-22.78 on day 7), (2) provoked preoperative pain (OR = 4.24; 95% CI, 1.40-12.78 on day 3 and OR = 5.35; 95% CI, 1.27-22.51 on day 7), (3) pulpless tooth (OR = 0.11; 95% CI, 0.02-0.57 on day 3), and (4) sonic activation during treatment (OR = 3.02; 95% CI, 1.39-6.57 on day 1 and OR = 3.01; 95% CI, 1.05-8.59 on day 3).
CONCLUSIONS
There was no significant difference in pain experience between teeth filled using AH Plus or TotalFill BC Sealer 1, 3, and 7 days after obturation. Patient- and treatment-related factors could influence postobturation pain.",2020,"There was no significant difference in pain experience between teeth filled using AH Plus® or TotalFill® BC sealer 1, 3 and 7 days after obturation.","['Patients referred for endodontic treatment were recruited with informed consent', 'One hundred and sixty eligible patients (163 teeth, 95.3%) returned their pain diary']","['tricalcium silicate and resin-based sealer techniques', 'TotalFill® BC (FKG Dentaire SA) or AH plus® (Dentsply Maillefer) sealer']","['Prognostic factors: (i) moderate/severe preoperative pain', 'No post-obturation pain difference', 'preoperative pain', 'pain experience', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0451366', 'cui_str': 'Pain diary'}]","[{'cui': 'C1668343', 'cui_str': 'tricalcium silicate'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}]","[{'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",160.0,0.191884,"There was no significant difference in pain experience between teeth filled using AH Plus® or TotalFill® BC sealer 1, 3 and 7 days after obturation.","[{'ForeName': 'Heng Seh Gabriel', 'Initials': 'HSG', 'LastName': 'Tan', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore.'}, {'ForeName': 'Kian Chong', 'Initials': 'KC', 'LastName': 'Lim', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore.'}, {'ForeName': 'Jeen Nee', 'Initials': 'JN', 'LastName': 'Lui', 'Affiliation': 'Department of Restorative Dentistry, National Dental Centre of Singapore, Singapore.'}, {'ForeName': 'Wei Ming Clement', 'Initials': 'WMC', 'LastName': 'Lai', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore.'}, {'ForeName': 'Victoria Soo Hoon', 'Initials': 'VSH', 'LastName': 'Yu', 'Affiliation': 'Faculty of Dentistry, National University of Singapore, Singapore. Electronic address: denyshv@nus.edu.sg.'}]",Journal of endodontics,['10.1016/j.joen.2020.10.013']
1290,33115345,Predicting Post-Concussion Symptom Recovery in Adolescents Using a Novel Artificial Intelligence.,"This pilot study explores the possibility of predicting post-concussion symptom recovery at one week post-injury using only objective diffusion tensor imaging (DTI) data inputs to a novel artificial intelligence (AI) system composed of Genetic Fuzzy Trees (GFT). Forty-three adolescents age 11 to 16 years with either mild traumatic brain injury or traumatic orthopedic injury were enrolled on presentation to the emergency department. Participants received a DTI scan three days post-injury, and their symptoms were assessed by the Post-Concussion Symptom Scale (PCSS) at 6 h and one week post-injury. The GFT system was trained using one-week total PCSS scores, 48 volumetric magnetic resonance imaging inputs, and 192 DTI inputs per participant over 225 training runs. Each training run contained a randomly selected 80% of the total sample followed by a 20% validation run. Over a different randomly selected sample distribution, GFT was also compared with six common classification methods. The cascading GFT structure controlled an effectively infinite solution space that classified participants as recovered or not recovered significantly better than chance. It demonstrated 100% and 62% classification accuracy in training and validation, respectively, better than any of the six comparison methods. Recovery sensitivity and specificity were 59% and 65% in the GFT validation set, respectively. These results provide initial evidence for the effectiveness of a GFT system to make clinical predictions of trauma symptom recovery using objective brain measures. Although clinical and research applications will necessitate additional optimization of the system, these results highlight the future promise of AI in acute care.",2020,"It demonstrated 100% and 62% classification accuracy in training and validation, respectively, better than any of the six comparison methods.",['Forty-three adolescents age 11 to 16 years with either mild traumatic brain injury or traumatic orthopedic injury were enrolled upon presentation to the emergency department'],[],['Recovery sensitivity and specificity'],"[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",[],"[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",43.0,0.0472421,"It demonstrated 100% and 62% classification accuracy in training and validation, respectively, better than any of the six comparison methods.","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Fleck', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Ernest', 'Affiliation': 'Thales USA Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Asch', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Caleb M', 'Initials': 'CM', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cohen', 'Affiliation': 'Department of Aerospace Engineering and Engineering Mechanics, University of Cincinnati College of Engineering and Applied Science, Cincinnati, Ohio, USA.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': ""Imaging Research Center, Radiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Kunkel', 'Affiliation': 'Thales USA Inc., Cincinnati, Ohio, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Krikorian', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Wade', 'Affiliation': ""Divisions of Emergency Medicine, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Babcock', 'Affiliation': ""Divisions of Physical Medicine and Rehabilitation, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}]",Journal of neurotrauma,['10.1089/neu.2020.7018']
1291,33123819,The effects of caffeine on olfactory function and mood: an exploratory study.,"Caffeine has been demonstrated to enhance olfactory function in rodents, but to date, the sparse research in humans has not shown any equivalent effects. However, due to the methodological nature of those human studies, a number of questions remain unanswered, which the present study aimed to investigate. Using a double-blind experimental design, participants (n = 40) completed baseline mood measures, standardised threshold and identification tests and were then randomly allocated to receive a capsule containing either 100 mg of caffeine or placebo, followed by the same olfactory tests and mood measures. Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function. In contrast, for non-caffeine consumers, caffeine acted to enhance odour (threshold) sensitivity but reduce odour identification. Overall, these findings demonstrate a complex profile of effects of caffeine on odour function and, given the evidence from the wider caffeine literature, it is proposed that the effects of caffeine might be limited to older populations.",2020,"Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function.","['participants (n = 40) completed baseline mood measures, standardised threshold and identification tests']","['capsule containing either 100 mg of caffeine or placebo', 'caffeine', 'Caffeine']","['odour function', 'olfactory function and mood']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0748987,"Results revealed that despite a trend toward elevated arousal following caffeine for habitual caffeine consumers, there were no changes in odour function.","[{'ForeName': 'Lorenzo D', 'Initials': 'LD', 'LastName': 'Stafford', 'Affiliation': 'Department of Psychology, University of Portsmouth, King Henry Building, King Henry I Street, Portsmouth, PO1 2DY, UK. lorenzo.Stafford@port.ac.uk.'}, {'ForeName': 'Kaylee', 'Initials': 'K', 'LastName': 'Orgill', 'Affiliation': 'Department of Psychology, University of Portsmouth, King Henry Building, King Henry I Street, Portsmouth, PO1 2DY, UK.'}]",Psychopharmacology,['10.1007/s00213-020-05695-6']
1292,33125909,Biomarker-driven therapies for previously treated squamous non-small-cell lung cancer (Lung-MAP SWOG S1400): a biomarker-driven master protocol.,"BACKGROUND
The Lung Cancer Master Protocol (Lung-MAP; S1400) is a completed biomarker-driven master protocol designed to address an unmet need for better therapies for squamous non-small-cell lung cancer. Lung-MAP (S1400) was created to establish an infrastructure for biomarker screening and rapid regulatory intent evaluation of targeted therapies and was the first biomarker-driven master protocol initiated with the US National Cancer Institute (NCI).
METHODS
Lung-MAP (S1400) was done within the National Clinical Trials Network of the NCI using a public-private partnership. Eligible patients were aged 18 years or older, had stage IV or recurrent squamous non-small-cell lung cancer, had previously been treated with platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. The study included a screening component using the FoundationOne assay (Foundation Medicine, Cambridge, MA, USA) for next-generation sequencing, and a clinical trial component with biomarker-driven substudies and non-match substudies for patients who were ineligible for biomarker-driven substudies. Patients were pre-screened and received their substudy assignment upon progression, or they were screened at progression and received their substudy assignment upon completion of testing. Patients could enrol onto additional substudies after progression on a substudy. The study is registered with ClinicalTrials.gov, NCT02154490, and all research related to Lung-MAP (S1400) is completed.
FINDINGS
Between June 16, 2014, and Jan 28, 2019, 1864 patients enrolled and 1841 (98·9%) submitted tissue. 1674 (90·9%) of 1841 patients had biomarker results, and 1404 (83·9%) of 1674 patients received a substudy assignment. Of the assigned patients, 655 (46·7%) registered to a substudy. The biomarker-driven substudies evaluated taselisib (targeting PIK3CA alterations), palbociclib (cell cycle gene alterations), AZD4547 (FGFR alteration), rilotumumab plus erlotinib (MET), talazoparib (homologous recombination repair deficiency), and telisotuzumab vedotin (MET). The non-match substudies evaluated durvalumab, and nivolumab plus ipilimumab for anti-PD-1 or anti-PD-L1-naive disease, and durvalumab plus tremelimumab for anti-PD-1 or anti-PD-L1 relapsed disease. Combining data from the substudies, ten (7·0%) of 143 patients responded to targeted therapy, 53 (16·8%) of 315 patients responded to anti-PD-1 or anti-PD-L1 therapy for immunotherapy-naive disease, and three (5·4%) of 56 responded to docetaxel in the second line of therapy. Median overall survival was 5·9 months (95% CI 4·8-7·8) for the targeted therapy groups, 7·7 months (6·7-9·2) for the docetaxel groups, and 10·8 months (9·4-12·3) for the anti-PD-1 or anti-PD-L1-containing groups. Median progression-free survival was 2·5 months (95% CI 1·7-2·8) for the targeted therapy groups, 2·7 months (1·9-2·9) for the docetaxel groups, and 3·0 months (2·7-3·9) for the anti-PD-1 or anti-PD-L1-containing groups.
INTERPRETATION
Lung-MAP (S1400) met its goal to quickly address biomarker-driven therapy questions in squamous non-small-cell lung cancer. In early 2019, a new screening protocol was implemented expanding to all histological types of non-small-cell lung cancer and to add focus on immunotherapy combinations for anti-PD-1 and anti-PD-L1 therapy-relapsed disease. With these changes, Lung-MAP continues to meet its goal to focus on unmet needs in the treatment of advanced lung cancers.
FUNDING
US National Institutes of Health, and AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Genentech, and Pfizer through the Foundation for the National Institutes of Health.",2020,"Median overall survival was 5·9 months (95% CI 4·8-7·8) for the targeted therapy groups, 7·7 months (6·7-9·2) for the docetaxel groups, and 10·8 months (9·4-12·3) for the anti-PD-1 or anti-PD-L1-containing groups.","['Between June 16, 2014, and Jan 28, 2019', 'Lung-MAP', 'Patients were pre-screened and received their substudy assignment upon progression, or they were screened at progression and received their substudy assignment upon completion of testing', 'Eligible patients were aged 18 years or older, had stage IV or recurrent squamous non-small-cell lung cancer, had previously been treated with platinum-based chemotherapy, and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2', 'patients who were ineligible for biomarker-driven substudies', '143 patients responded to targeted therapy, 53 (16·8%) of 315 patients responded to', '1674 (90·9%) of 1841 patients had biomarker results, and 1404 (83·9%) of 1674 patients received a substudy assignment', '1864 patients enrolled and 1841 (98·9%) submitted tissue']","['docetaxel', 'anti-PD-1 or anti-PD-L1 therapy']","['Median progression-free survival', 'Lung-MAP', 'Median overall survival', 'palbociclib (cell cycle gene alterations), AZD4547 (FGFR alteration), rilotumumab plus erlotinib (MET), talazoparib (homologous recombination repair deficiency), and telisotuzumab vedotin (MET']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1720176', 'cui_str': 'Upon'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0243037', 'cui_str': 'cdc Genes'}, {'cui': 'C2981795', 'cui_str': 'AZD4547'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}, {'cui': 'C2743963', 'cui_str': 'rilotumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C4042960', 'cui_str': 'talazoparib'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}]",1864.0,0.0692009,"Median overall survival was 5·9 months (95% CI 4·8-7·8) for the targeted therapy groups, 7·7 months (6·7-9·2) for the docetaxel groups, and 10·8 months (9·4-12·3) for the anti-PD-1 or anti-PD-L1-containing groups.","[{'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: mredman@fredhutch.org.'}, {'ForeName': 'Vassiliki A', 'Initials': 'VA', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'Department of Thoracic Head and Neck Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Minichiello', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Hirsch', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Mack', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Schwartz', 'Affiliation': 'Department of Radiology, Division of Abdominal Imaging, Columbia University Medical College, New York, NY, USA.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Vokes', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Hematology and Oncology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Leighl', 'Affiliation': 'Princess Margaret Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Highleyman', 'Affiliation': 'SWOG Data Operations Center, Cancer Research and Biostatistics, Seattle, WA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Miwa', 'Affiliation': 'SWOG Operations Office, San Antonio, TX, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'LeBlanc', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA; Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Shakun', 'Initials': 'S', 'LastName': 'Malik', 'Affiliation': 'National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Vincent A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': 'Foundation Medicine, Cambridge, MA, USA.'}, {'ForeName': 'Ellen V', 'Initials': 'EV', 'LastName': 'Sigal', 'Affiliation': 'Friends of Cancer Research, Washington, DC, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Adam', 'Affiliation': 'Foundation for the National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wholley', 'Affiliation': 'Foundation for the National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Sigman', 'Affiliation': 'CCS Associates, San Jose, CA, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Smolich', 'Affiliation': 'CCS Associates, San Jose, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Group Chair's Office and Knight Cancer Institute, School of Medicine, Oregon Health and Science University, Portland, OR, USA.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Department of Internal Medicine, UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'Department of Internal Medicine, UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Department of Medicine, Yale Cancer Center, New Haven, CT, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30475-7']
1293,33125944,Avelumab-cetuximab-radiotherapy versus standards of care in locally advanced squamous-cell carcinoma of the head and neck: The safety phase of a randomised phase III trial GORTEC 2017-01 (REACH).,"BACKGROUND
Based on the hypothesis of synergistic effect of avelumab with cetuximab and radiotherapy, this new combination is tested in a randomised trial against two well-established standard of care (SOC) in locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN).
METHODS
This phase III trial comprises two cohorts of patients deemed fit to receive cisplatin (100 mg/m 2 Q3W) (cohort 1) or unfit to cisplatin (cohort 2). The SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin in cohort 1 (arm A) and with weekly cetuximab in cohort 2 (arm D). In both cohorts, experimental arms (arms B and C) were IMRT with cetuximab and avelumab (10 mg/kg day 7 and every 2 weeks) followed by avelumab every two weeks for 12 months. A safety phase was planned among the first 41 patients in experimental arms by monitoring grade ≥IV adverse events (AEs) with an unacceptable rate of 35%.
RESULTS
Between September 2017 and August 2018, 82 patients with LA-SCCHN were randomised including 41 patients in experimental arms. All patients of experimental arms except one (arm C) received entire radiotherapy as planned. Most common grade ≥III AEs were mucositis, radio-dermatitis, and dysphagia. Grade ≥IV AEs occurred in 5/41 (12%) patients, all in arm C (no grade V). This rate was acceptable according to the hypotheses of the safety phase. In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION
The avelumab-cetuximab-RT combination was tolerable for patients with LA-SCCHN, and the approval was given for continuing the trial without modification. CLINICALTRIAL.GOV: NCT02999087.",2020,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION
","['locally advanced squamous-cell carcinoma of the head and neck (LA-SCCHN', 'Between September 2017 and August 2018, 82 patients with LA-SCCHN', 'locally advanced squamous-cell carcinoma of the head and neck']","['avelumab with cetuximab and radiotherapy', 'cisplatin', 'avelumab-cetuximab-RT combination', 'Avelumab-cetuximab-radiotherapy', 'SOC was Intensity Modulated Radiation Therapy (IMRT) with cisplatin', 'unfit to cisplatin', 'IMRT with cetuximab and avelumab', 'entire radiotherapy']","['Grade ≥IV AEs', 'mucositis, radio-dermatitis, and dysphagia', 'grade ≥IV AEs', 'grade V haemorrhage']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439751', 'cui_str': 'Entire'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",82.0,0.0711299,"In the SOC arms, grade ≥IV AEs occurred in 3/21 patients (14%) in arm A and 2/20 (10%) in arm D. One grade V haemorrhage occurred in arm A.
CONCLUSION
","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Aupérin', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Xushan', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sire', 'Affiliation': 'Centre Hospitalier de Lorient, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Centre Guillaume le Conquérant, Le Havre, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Coutte', 'Affiliation': 'CHU, Amiens, France.'}, {'ForeName': 'Cedrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Miroir', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Liem', 'Affiliation': 'Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': 'ICO Rene-Gauducheau, Nantes, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Even', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Nguyen', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Maillard', 'Affiliation': 'Gustave-Roussy Institute, Villejuif, France.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Colin-Batailhou', 'Affiliation': 'GORTEC, Tours, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Francois Baclesse, Caen, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.09.008']
1294,33091706,Methylene blue reduces incidence of early postoperative cognitive disorders in elderly patients undergoing major non-cardiac surgery: An open-label randomized controlled clinical trial.,"STUDY OBJECTIVE
The purpose of the present study was to investigate whether methylene blue (MB) could reduce the incidences of postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD) in elderly patients undergoing major non-cardiac surgery.
DESIGN
Prospective, randomized, open-label clinical trial.
SETTING
University-affiliated hospital.
PATIENTS
Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery.
INTERVENTIONS
Elderly patients undergoing non-cardiac major surgery were randomly assigned to MB group (n = 124), who receiving intravenous infusion of 2 mg/kg MB within 60 min immediately after anesthetic induction, or control group (n = 124), who receiving equal volume saline in the same way.
MEASUREMENTS
All patients were evaluated with delirium and neuropsychological batteries before and after surgery, as well as perioperative adverse events. Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
MAIN RESULTS
There were total 39 cases(15.7%)experienced POD. The incidence of POD in MB group was significantly less than that in control group (7.3% vs. 24.2%, OR = 0.24, 95%CI: 0.11-0.53, p < 0.001). The incidence of early POCD at postoperative 7th day in MB group was also less than that in control group (16.1% vs. 40.2%, OR = 0.30, 95% CI: 0.16-0.57, p < 0.001). The adverse events were comparable in both groups. In addition, there was no significant correlation between POD/POCD and levels of SOD or HCY.
CONCLUSION
We conclude that intraoperative intravenous 2 mg/kg MB could significantly reduce the incidences of POD and early POCD in elderly surgical patients, while not remarkably increase incidence of perioperative adverse events, suggesting MB may be clinically effective and safe for prevention of early postoperative neurocognitive disorders.",2020,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","['Two hundred and forty-eight elderly patients scheduled for non-cardiac surgery', 'elderly patients undergoing major non-cardiac surgery', 'elderly surgical patients', 'University-affiliated hospital', 'Elderly patients undergoing non-cardiac major surgery']","['methylene blue (MB', 'Methylene blue', 'intravenous infusion of 2\xa0mg/kg\xa0MB within 60\xa0min immediately after anesthetic induction, or control group (n\xa0=\xa0124), who receiving equal volume saline', 'MB']","['POD/POCD and levels of SOD or HCY', 'incidences of POD and early POCD', 'incidence of early POCD', 'postoperative delirium (POD) and early postoperative cognitive dysfunction (POCD', 'incidence of POD', 'delirium and neuropsychological batteries', 'adverse events', 'perioperative adverse events', 'Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY', 'early postoperative cognitive disorders']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C4721773', 'cui_str': 'Postoperative cognitive dysfunction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0451331', 'cui_str': 'Neuropsychological battery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",248.0,0.0572685,"Two plasma biomarkers superoxide dismutase (SOD) and homocysteine (HCY) were measured pre- and post-operatively.
","[{'ForeName': 'Yixu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China.'}, {'ForeName': 'Ruijing', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Shitong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Fudan University, Shanghai 200040, PR China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Cancer Center, Fudan University, Shanghai 200032, PR China; Department of Oncology, Shanghai Medical College, Fudan University,Shanghai 200032, PR China. Electronic address: snapzhang@aliyun.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110108']
1295,33095777,Perceived facilitators and barriers among physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only in patients eligible for knee replacement: A qualitative interview study nested in the QUADX-1 trial.,"AIM
Clinical guidelines recommend non-surgical treatment before surgery is considered in patients eligible for knee replacement. Surgical treatment is provided by orthopedic surgeons and exercise therapy is provided by physical therapists. The aim of this study was to identify perceived facilitators and barriers-among orthopedic surgeons and physical therapists-towards coordinated non-surgical and surgical treatment of patients eligible for knee replacement using pre-operative home-based exercise therapy with one exercise.
METHODS
This qualitative study is embedded within the QUADX-1 randomized trial that investigates a model of coordinated non-surgical and surgical treatment for patients eligible for knee replacement. Physical therapists and orthopedic surgeons working with patients with knee osteoarthritis in their daily clinical work were interviewed (one focus group and four single interviews) to explore their perceived facilitators and barriers related to pre-operative home-based exercise therapy with one exercise-only in patients eligible for knee replacement. Interviews were analyzed using thematic analysis.
RESULTS
From the thematic analysis three main themes emerged: 1) Physical therapists' dilemma with one home-based exercise, 2) Orthopedic surgeons' dilemma with exercise, and 3) Coordinated non-surgical and surgical care.
CONCLUSION
We found that the pre-operative exercise intervention created ambivalence in the professional role of both the physical therapists and orthopedic surgeons. The physical therapists were skeptical towards over-simplified exercise therapy. The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement. The consequence of these barriers and ambivalence in the professional role is important to consider when planning implementation of the model of coordinated non-surgical and surgical treatment.
TRIAL REGISTRATION
ClinicalTrials.gov, ID: NCT02931058.",2020,The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement.,"['patients eligible for', 'patients eligible for knee replacement', 'patients with knee osteoarthritis in their daily clinical work']","['explore their perceived facilitators and barriers related to pre-operative home-based exercise therapy with one exercise-only', 'physical therapists and orthopedic surgeons to pre-operative home-based exercise with one exercise-only', 'orthopedic surgeons and physical therapists-towards coordinated non-surgical and surgical treatment', ""Physical therapists' dilemma with one home-based exercise, 2) Orthopedic surgeons' dilemma with exercise, and 3) Coordinated non-surgical and surgical care"", 'Physical therapists', 'knee replacement using pre-operative home-based exercise therapy with one exercise', 'exercise therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",[],,0.0574234,The orthopedic surgeons were skeptical towards the potential lack of (long-term) effect of exercise therapy in patients eligible for knee replacement.,"[{'ForeName': 'Rasmus Skov', 'Initials': 'RS', 'LastName': 'Husted', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Michael Skovdal', 'Initials': 'MS', 'LastName': 'Rathleff', 'Affiliation': 'Research Unit for General Practice in Aalborg, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopedic Surgery, Clinical Orthopedic Research Hvidovre (CORH), Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Kirk', 'Affiliation': 'Department of Clinical Research, Copenhagen University Hospital Amager-Hvidovre, Hvidovre, Denmark.'}]",PloS one,['10.1371/journal.pone.0241175']
1296,33095798,A cluster feasibility trial to explore the uptake and use of e-cigarettes versus usual care offered to smokers attending homeless centres in Great Britain.,"Smoking rates in the UK are at an all-time low but this masks considerable inequalities; prevalence amongst adults who are homeless remains four times higher than the national average. The objective of this trial was to assess the feasibility of supplying free e-cigarette starter kits to smokers accessing homeless centres and to estimate parameters to inform a possible future larger trial. In this feasibility cluster trial, four homeless centres in Great Britain were non-randomly allocated to either a Usual Care (UC) or E-Cigarette (EC) arm. Smokers attending the centres were recruited by staff. UC arm participants (N = 32) received advice to quit and signposting to the local Stop Smoking Service. EC arm participants (N = 48) received an EC starter kit and 4-weeks supply of e-liquid. Outcome measures were recruitment and retention rates, use of ECs, smoking cessation/reduction and completion of measures required for economic evaluation. Eighty (mean age 43 years; 65% male) of the 153 eligible participants who were invited to participate, were successfully recruited (52%) within a five-month period, and 47 (59%) of these were retained at 24 weeks. The EC intervention was well received with minimal negative effects and very few unintended consequences (e.g. lost, theft, adding illicit substances). In both study arm, depression and anxiety scores declined over the duration of the study. Substance dependence scores remained constant. Assuming those with missing follow up data were smoking, CO validated sustained abstinence at 24 weeks was 3/48 (6.25%) and 0/32 (0%) respectively for the EC and UC arms. Almost all participants present at follow-up visits completed data collection for healthcare service and health-related quality of life measures. Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.",2020,Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.,"['Smokers attending the centres were recruited by staff', 'smokers accessing homeless centres', 'smokers attending homeless centres in Great Britain', 'age 43 years; 65% male) of the 153 eligible participants who were invited to participate, were successfully recruited (52%) within a five-month period, and 47 (59%) of these were retained at 24 weeks', 'Eighty (mean', 'four homeless centres in Great Britain']","['advice to quit and signposting to the local Stop Smoking Service', 'Usual Care (UC) or E-Cigarette (EC', 'EC', 'supplying free e-cigarette starter kits', 'e-cigarettes versus usual care', 'EC starter kit and 4-weeks supply of e-liquid']","['recruitment and retention rates, use of ECs, smoking cessation/reduction and completion of measures required for economic evaluation', 'Smoking rates', 'depression and anxiety scores', 'Substance dependence scores']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0150099', 'cui_str': 'Economic Evaluation'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038580', 'cui_str': 'Substance dependence'}]",153.0,0.0773539,Providing an e-cigarette starter kit to smokers experiencing homelessness was associated with reasonable recruitment and retention rates and promising evidence of effectiveness and cost-effectiveness.,"[{'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Usher Institute and SPECTRUM Consortium, Old Medical School, University of Edinburgh, Edinburgh, Scotland.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ford', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Robson', 'Affiliation': ""National Addiction Centre and SPECTRUM Consortium, Addictions Department & ARC South London, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, England.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, England.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Best', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Sciences, University of York, York, England.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Uny', 'Affiliation': 'Institute for Social Marketing and Health, Faculty of Health Sciences and Sport, University of Stirling, Stirling, Scotland.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Cox', 'Affiliation': 'Centre for Addictive Behaviours Research, London South Bank University, London, England.'}]",PloS one,['10.1371/journal.pone.0240968']
1297,33095817,The effect of metacognitive training on confidence and strategic reminder setting.,"Individuals often choose between remembering information using their own memory ability versus using external resources to reduce cognitive demand (i.e. 'cognitive offloading'). For example, to remember a future appointment an individual could choose to set a smartphone reminder or depend on their unaided memory ability. Previous studies investigating strategic reminder setting found that participants set more reminders than would be optimal, and this bias towards reminder-setting was predicted by metacognitive underconfidence in unaided memory ability. Due to the link between underconfidence in memory ability and excessive reminder setting, the aim of the current study was to investigate whether metacognitive training is an effective intervention to a) improve metacognitive judgment accuracy, and b) reduce bias in strategic offloading behaviour. Participants either received metacognitive training which involved making performance predictions and receiving feedback on judgment accuracy, or were part of a control group. As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias. However, contrary to predictions, both experimental and control groups were significantly biased toward reminder-setting, and did not differ significantly. Therefore, reducing metacognitive bias was not sufficient to eliminate the bias towards reminders. We suggest that the reminder bias likely results in part from erroneous metacognitive evaluations, but that other factors such as a preference to avoid cognitive effort may also be relevant. Finding interventions to mitigate these factors could improve the adaptive use of external resources.",2020,"As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias.",[],['metacognitive training'],"['metacognitive training increased judgment accuracy', 'metacognitive bias']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",,0.0170334,"As predicted, metacognitive training increased judgment accuracy: participants in the control group were significantly underconfident in their memory ability, whereas the experimental group showed no significant metacognitive bias.","[{'ForeName': 'Nicole C', 'Initials': 'NC', 'LastName': 'Engeler', 'Affiliation': 'UCL Institute of Cognitive Neuroscience, London, United Kingdom.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Gilbert', 'Affiliation': 'UCL Institute of Cognitive Neuroscience, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0240858']
1298,33096946,Long-Term Outcomes of Two Ipsilateral vs Single Double-J Stent After Laser Endoureterotomy for Bilharzial Ureteral Strictures.,"Background: Laser endoureterotomy became a preferable choice for managing benign ureteral strictures. Ureteral stricture caused by bilharzias is characterized by focal destruction of ureteral musculature, ending by fibrosis, making it poor responder to endoureterotomy. There is no consensus about the ideal ureteral stent size after endoureterotomy. However, many researches recommend larger stents caliber (12-14F). We assess long-term efficacy of insertion of two ipsilateral Double-J stents vs single Double-J stent after laser endoureterotomy for bilharzial ureteral stricture. Materials and Methods: Within 4 years, 70 patients underwent retrograde laser endoureterotomy for bilharzial ureteral stricture (diagnosed by positive history of bilharziasis, positive serology test, and/or bilharzial cystoscopic finding). Patients with history of stone, urologic or pelvic surgery were excluded. Patients were randomized into two groups: the first group (35 patients) received ipsilateral two Double-J (7F each) postendoureterotomy, whereas the second group (35 patients) received one Double-J (7F). Double-Js were removed after 8 weeks. Follow-up was done regularly by clinical interpretation and imaging studies. Patients' characteristics, operative data, and postoperative outcomes (subjectively and objectively) were compared in both groups. Results: Sixty-three patients completed follow-up >18 months, mean follow-up 30 ± 4 months [19-41], and mean stricture length 1.4 ± 0.6 cm [0.5-3.0], with no statistical significance between both groups. Success proved by relief of symptoms and radiographic resolution of obstruction. The overall success rate was significantly better in 2-Double-J group than in 1-Double-J group (83.9% vs 53.1%) p = 0.009, and also for stricture >1.5 cm (85.7% vs 38.5%) p = 0.018, respectively. Conclusions: Insertion of two ipsilateral Double-J, after laser endoureterotomy for bilharzial ureteral stricture associated with long-term success rate better than insertion of 1-Double-J, especially for stricture segment >1.5 cm.",2020,"The overall success rate was significantly better in 2-DJ group than in 1-DJ group (83.9% Vs 53.1%) p =0.009, and also for stricture > 1.5 cm (85.7% Vs 38.5%) p=0.018 respectively.
","['Bilharzial ureteral strictures', 'Patients with history of stone, urologic or pelvic surgery were excluded', '70 patients underwent', 'for bilharzial ureteral stricture (diagnosed by positive history of bilhaziasis, positive serology test and/or bilhazial cystocopic finding']","['1-DJ', 'two ipsilateral versus single Double-J stent', 'ipsilateral two DJ (7-Fr each) post endouretrotomy, while the second group (32 patients) received one DJ (7-Fr', 'retrograde laser endouretrotomy', 'two ipsilateral Double-J stents versus single DJ stent', '2-DJ']","['mean stricture length 1.4', 'relief of symptoms and radiographic resolution of obstruction', 'overall success rate']","[{'cui': 'C3887590', 'cui_str': 'Stricture of ureter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0242089', 'cui_str': 'Serology positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.0771716,"The overall success rate was significantly better in 2-DJ group than in 1-DJ group (83.9% Vs 53.1%) p =0.009, and also for stricture > 1.5 cm (85.7% Vs 38.5%) p=0.018 respectively.
","[{'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mohyelden', 'Affiliation': 'Urology Department, Faculty of medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Hussein Aly', 'Initials': 'HA', 'LastName': 'Hussein', 'Affiliation': 'Urology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hisham A', 'Initials': 'HA', 'LastName': 'El Helaly', 'Affiliation': 'Urology Department, Faculty of medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Hamdy', 'Initials': 'H', 'LastName': 'Ibrahem', 'Affiliation': 'Urology Department, Faculty of medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Abdelwahab', 'Affiliation': 'Urology Department, Faculty of Medicine, Suez Canal University, Ismailia, Egypt.'}]",Journal of endourology,['10.1089/end.2020.0956']
1299,33239474,"Behavior Change, Egg Consumption, and Child Nutrition: A Cluster Randomized Controlled Trial.","BACKGROUND AND OBJECTIVES
Malnutrition is a significant contributor to child morbidity and mortality globally. Egg consumption has been associated with improved child nutrition yet is rare in rural, resource-poor settings. We test the effects of a culturally tailored behavior change intervention to increase child egg consumption.
METHODS
A 3-arm cluster randomized controlled trial was conducted in rural Burkina Faso with 260 mother-child dyads. Children aged 4 to 17 months from 18 villages were included; those with reported history of malnutrition or egg allergy were excluded. Each child in the full intervention arm received 4 chickens, and mothers received the 10-month behavior change package. Participants in the partial intervention arm received only the behavior change package.
RESULTS
In this analysis of 250 children, the full (β = 4.3; P = 6.6 × 10 -12 ) and the partial (β = 1.0; P = .02) interventions significantly increased egg consumption. The full intervention also significantly increased poultry production (β = 11.6; 95% confidence interval 8.3-15; P = 1.1 × 10 -5 ) and women's decision-making about eggs (β = .66; P = .02), and significantly decreased wasting (β = .58; P = .03) and underweight (β = .47; P = .02).
CONCLUSIONS
The culturally tailored behavior change package significantly increased child egg consumption. When coupled with the gift of chickens, the behavior change intervention yielded a greater increase in egg consumption and significantly reduced wasting and underweight. Behavior change strategies to increase egg consumption should be considered among nutrition and health programs in resource-poor settings where poultry is available.",2020,"The full intervention also significantly increased poultry production (β = 11.6; 95% confidence interval 8.3-15; P = 1.1 × 10 -5 ) and women's decision-making about eggs (β = .66; P = .02), and significantly decreased wasting (β = .58; P = .03) and underweight (β = .47; P = .02).
","['rural Burkina Faso with 260 mother-child dyads', 'Children aged 4 to 17 months from 18 villages were included; those with reported history of malnutrition or egg allergy were excluded']",['culturally tailored behavior change intervention'],"['child egg consumption', 'egg consumption', 'Behavior Change, Egg Consumption, and Child Nutrition', 'poultry production', 'wasting and underweight']","[{'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0559469', 'cui_str': 'Allergy to edible egg'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C1720755', 'cui_str': 'Child nutrition'}, {'cui': 'C0032850', 'cui_str': 'Fowls, Domestic'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]",250.0,0.089741,"The full intervention also significantly increased poultry production (β = 11.6; 95% confidence interval 8.3-15; P = 1.1 × 10 -5 ) and women's decision-making about eggs (β = .66; P = .02), and significantly decreased wasting (β = .58; P = .03) and underweight (β = .47; P = .02).
","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McKune', 'Affiliation': 'Departments of Environmental and Global Health, smckune@ufl.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Stark', 'Affiliation': 'Departments of Environmental and Global Health.'}, {'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Sapp', 'Affiliation': 'Departments of Environmental and Global Health.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Biostatics, and.'}, {'ForeName': 'Crystal M', 'Initials': 'CM', 'LastName': 'Slanzi', 'Affiliation': 'Psychology, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Emily V', 'Initials': 'EV', 'LastName': 'Moore', 'Affiliation': 'Departments of Environmental and Global Health.'}, {'ForeName': 'Anteneh', 'Initials': 'A', 'LastName': 'Omer', 'Affiliation': 'School of Nutrition, Food Science and Technology, Hawassa University, Hawassa, Ethiopia; and.'}, {'ForeName': 'Aissata', 'Initials': 'A', 'LastName': ""Wereme N'Diaye"", 'Affiliation': ""Institut de l'Environnement et de Recherches Agricoles, Ouagadougou, Burkina Faso.""}]",Pediatrics,['10.1542/peds.2020-007930']
1300,33239521,Does a Question Prompt List Improve Perceived Involvement in Care in Orthopaedic Surgery Compared with the AskShareKnow Questions? A Pragmatic Randomized Controlled Trial.,"BACKGROUND
Most conditions in orthopaedic surgery are preference-sensitive, where treatment choices are based on the patient's values and preferences. One set of tools increasingly used to help align treatment choices with patient preferences are question prompt lists (QPLs), which are comprehensive lists of potential questions that patients can ask their physicians during their encounters. Whether or not a comprehensive orthopaedic-specific question prompt list would increase patient-perceived involvement in care more effectively than might three generic questions (the AskShareKnow questions) remains unknown; learning the answer would be useful, since a three-question list is easier to use compared with the much lengthier QPLs.
QUESTION/PURPOSE
Does an orthopaedic-specific question prompt list increase patient-perceived involvement in care compared with the three generic AskShareKnow questions?
METHODS
We performed a pragmatic randomized controlled trial of all new patients visiting a multispecialty orthopaedic clinic. A pragmatic design was used to mimic normal clinical care that compared two clinically acceptable interventions. New patients with common orthopaedic conditions were enrolled between August 2019 and November 2019 and were randomized to receive either the intervention QPL handout (orthopaedic-specific QPL with 45 total questions, developed with similar content and length to prior QPLs used in hand surgery, oncology, and palliative care) or a control handout (the AskShareKnow model questions, which are: ""What are my options? What are the benefits and harms of those options? How likely are each of those benefits and harms to happen to me?"") before their visits. A total of 156 patients were enrolled, with 78 in each group. There were no demographic differences between the study and control groups in terms of key variables. After the visit, patients completed the Perceived Involvement in Care Scale (PICS), a validated instrument designed to evaluate patient-perceived involvement in their care, which served as the primary outcome measure. This instrument is scored from 0 to 13, with higher scores indicating higher perceived involvement.
RESULTS
There was no difference in mean PICS scores between the intervention and control groups (QPL 8.3 ± 2.3, control 8.5 ± 2.3, mean difference 0.2 [95% CI -0.53 to 0.93 ]; p = 0.71.
CONCLUSION
In patients undergoing orthopaedic surgery, a QPL does not increase patient-perceived involvement in care compared with providing patients the three AskShareKnow questions. Implementation of the three AskShareKnow questions can be a more efficient way to improve patient-perceived involvement in their care compared with a lengthy QPL.
LEVEL OF EVIDENCE
Level II, therapeutic study.",2020,"Does an orthopaedic-specific question prompt list increase patient-perceived involvement in care compared with the three generic AskShareKnow questions?
","['patients undergoing orthopaedic surgery', 'all new patients visiting a multispecialty orthopaedic clinic', 'A total of 156 patients were enrolled, with 78 in each group', 'New patients with common orthopaedic conditions were enrolled between August 2019 and November 2019']","['QPL', 'intervention QPL handout (orthopaedic-specific QPL with 45 total questions, developed with similar content and length to prior QPLs used in hand surgery, oncology, and palliative care) or a control handout (the AskShareKnow model questions']","['mean PICS scores', 'Perceived Involvement in Care Scale (PICS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3838700', 'cui_str': 'Orthopedic clinic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",156.0,0.0613203,"Does an orthopaedic-specific question prompt list increase patient-perceived involvement in care compared with the three generic AskShareKnow questions?
","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mariano', 'Affiliation': 'D. J. Mariano, A. Liu, S. L. Eppler, M. J. Gardner, S. Hu, M. Safran, L. Chou, D. F. Amanatullah, R. N. Kamal, VOICES Health Policy Research Center, Department of Orthopaedic Surgery, Stanford University, Redwood City, CA, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Eppler', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Gardner', 'Affiliation': ''}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Safran', 'Affiliation': ''}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Chou', 'Affiliation': ''}, {'ForeName': 'Derek F', 'Initials': 'DF', 'LastName': 'Amanatullah', 'Affiliation': ''}, {'ForeName': 'Robin N', 'Initials': 'RN', 'LastName': 'Kamal', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001582']
1301,33104028,Randomized Controlled Trial of Multi-Component Cognitive Stimulation Therapy (SADEM) in Community-Dwelling Demented Adults.,"BACKGROUND
Dementia is a persistent, progressive state of cognitive decline against which pharmacological intervention has a modest efficacy, reducing behavioral but not cognitive symptoms. Therefore, different non-pharmacological therapies have been developed; the most scientifically recognized are cognitive therapies that have improved cognitive function and daily life activities.
OBJECTIVE
To evaluate the effectiveness of a multicomponent cognitive stimulation therapy (SADEM) on cognitive and behavioral function and daily life activities in patients with mild stage dementia.
METHODS
Controlled clinical trial with pre- and post-intervention (12 months) and follow-up (24 months after) evaluations. Participants (67) diagnosed with mild dementia were randomly assigned to intervention group (n = 39) or control group (n = 28). The intervention took place throughout one year and consisted of two weekly 90-minute sessions and one more a year after a monthly follow-up. Instruments were used to evaluate outcomes in cognitive, behavioral, and affective domains.
RESULTS
The results showed statistically significant differences, with improvement in the cognitive outcomes and the Dementia Index post-intervention (p = 0.01). No progression of the disease was observed at the end of the study.
CONCLUSION
The multicomponent intervention tested had positive effects on cognitive and behavioral functions and daily life activities in people with mild stage dementia, delaying progression for at least two years.",2020,"The multicomponent intervention tested had positive effects on cognitive and behavioral functions and daily life activities in people with mild stage dementia, delaying progression for at least two years.","['Community-Dwelling Demented Adults', 'patients with mild stage dementia', 'Participants (67) diagnosed with mild dementia', 'people with mild stage dementia, delaying progression for at least two years']","['multicomponent cognitive stimulation therapy (SADEM', 'pre- and post-intervention', 'Multi-Component Cognitive Stimulation Therapy (SADEM']","['cognitive and behavioral functions and daily life activities', 'cognitive, behavioral, and affective domains', 'cognitive outcomes and the Dementia Index post-intervention', 'cognitive and behavioral function and daily life activities']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0860630', 'cui_str': 'Demented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3494623', 'cui_str': 'Mild dementia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",67.0,0.0736016,"The multicomponent intervention tested had positive effects on cognitive and behavioral functions and daily life activities in people with mild stage dementia, delaying progression for at least two years.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Juárez-Cedillo', 'Affiliation': 'Unidad de Investigación en Epidemiología y Servicios de Salud, Área Envejecimiento, Instituto Mexicano del Seguro Social, Centro Medico Nacional Siglo XXI, Mexico City, México.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Gutiérrez-Gutiérrez', 'Affiliation': 'Department of Neurology and Psychiatry, National Institute of Medical Sciences and Nutrition ""Salvador Zubirán"", National Institutes of Health, Mexico City, Mexico.'}, {'ForeName': 'Luis Alejandro', 'Initials': 'LA', 'LastName': 'Sánchez-Hurtado', 'Affiliation': 'Departamento de Medicina de Cuidados Críticos, Hospital Especialidades Centro Médico Nacional La Raza, Instituto Mexicano de Seguridad Social, Mexico City, Mexico.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Epidemiology, Endocrinology & Nutrition Research, Hospital Infantil de México Federico Gomez; (SSA), Mexico City, Mexico.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Juarez-Cedillo', 'Affiliation': 'Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200574']
1302,33108030,One-year aerobic interval training in outpatients with schizophrenia: A randomized controlled trial.,"Although aerobic interval training (AIT) is recognized to attenuate the risk of cardiovascular disease (CVD) and premature mortality, it appears that it rarely arrives at patients' doorsteps. Thus, this study investigated 1-year effects and feasibility of AIT delivered with adherence support in collaborative care of outpatients with schizophrenia. Forty-eight outpatients (28 men, 35 [31-38] (mean [95% confidence intervals]) years; 20 women, 36 [30-41] years) with schizophrenia spectrum disorders (ICD-10) were randomized to either a collaborative care group provided with municipal transportation service and training supervision (walking/running 4 × 4 minutes at ~90% of peak heart rate; HR peak ) 2 d wk -1 at the clinic (TG) or a control group (CG) given 2 introductory AIT sessions and advised to continue training. Directly assessed peak oxygen uptake ( V ˙ O 2 peak ) increased in the TG after 3 months (2.3 [0.6-4.4] mL kg -1 min -1 , Cohen's d = 0.33[-4.63 to 4.30], P = 0.04), 6 months (2.7 [0.5-4.8] mL kg -1 min -1 , Cohen's d = 0.42[-4.73 to 4.11], P = 0.02) and 1 year (4.6 [2.3-6.8] mL kg -1 min -1 , Cohen's d = 0.70[-4.31 to 4.10], P < 0.001) compared to the CG. One-year cardiac effects revealed higher HR peak (7 [2-11] b min -1 , Cohen's d = 0.34[-8.48 to 8.65], P = 0.01), while peak stroke volume tended to be higher (0.9 [-0.2 to 2.0] mL b -1 , Cohen's d = 0.35[-1.62 to 2.01], P = 0.11) in the TG compared to the CG. Conventional risk factors (body weight, waist circumference, blood pressure, and lipids/glucose) remained unaltered in both groups. One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG). AIT was successfully included in long-term collaborative care of outpatients with schizophrenia and yielded improved V ˙ O 2 peak , advocating this model for aerobic capacity improvement and CVD risk reduction in future treatment.",2020,One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG).,"['years; 20 women, 36 [30-41] years) with schizophrenia spectrum disorders (ICD-10', 'outpatients with schizophrenia and yielded improved V', 'outpatients with schizophrenia', 'Forty-eight outpatients (28 men, 35 [31-38] (mean [95% confidence intervals']","['collaborative care group provided with municipal transportation service and training supervision (walking/running 4\xa0×\xa04\xa0minutes at ~90% of peak heart rate; HR peak ) 2\xa0d\xa0wk -1 at the clinic (TG) or a control group (CG) given 2 introductory AIT sessions and advised to continue training', 'aerobic interval training', 'aerobic interval training (AIT']","['Conventional risk factors (body weight, waist circumference, blood pressure, and lipids/glucose', 'aerobic capacity improvement and CVD risk reduction', 'One-year AIT adherence rates', 'peak oxygen uptake ( V', 'peak stroke volume', 'HR peak']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",48.0,0.0540508,One-year AIT adherence rates were 15/25 (TG; different from CG: P < 0.001) and 0/23 (CG).,"[{'ForeName': 'Mathias Forsberg', 'Initials': 'MF', 'LastName': 'Brobakken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Nygård', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Ismail Cüneyt', 'Initials': 'IC', 'LastName': 'Güzey', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Morken', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Solveig Klaebo', 'Initials': 'SK', 'LastName': 'Reitan', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Jørn', 'Initials': 'J', 'LastName': 'Heggelund', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Vedul-Kjelsaas', 'Affiliation': 'Department of Mental Health, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13808']
1303,33115615,Gravity and Mastoid Effusion.,"BACKGROUND
Asymptomatic mastoid effusions have recently been observed in astronauts returning from long-term spaceflight. In hospitalized patients, mastoid effusion increases the risks for bacterial otitis and mastoiditis. We reasoned that cephalad fluid shifts during strict -6° head down tilt bed rest could reproduce space-flight associated mastoid effusion and that artificial gravity may reverse the response.
METHODS
The recent Artificial Gravity Bed Rest Study-European Space Agency study (AGBRESA) tested influences of artificial gravity during 60 days head down bed rest on a short-arm human centrifuge in healthy participants. The two intervention groups received daily artificial gravity with 30 minutes continuous artificial gravity or intermittent artificial gravity. A third group served as a control group and received no artificial gravity. We assessed cranial magnetic resonance images for mastoid effusions 1 day before bed rest, at days 14 and 52 of bed rest, and 3 days after bed rest.
RESULTS
None of the participants exhibited mastoid effusions before bed rest. Six participants showed mastoid effusions at bed rest day 14 (4 continuous, 2 intermittent, 0 control). Fifteen participants showed mastoid effusions at bed rest day 52 and 3 days after bed rest (7 continuous, 3 intermittent, 5 control).
CONCLUSIONS
Mastoid effusions commonly occur during strict head down tilt bed rest. The model can be applied to study the mechanisms and potential countermeasures for space flight-associated mastoid effusions. Formation of mastoid effusions during head down tilt bed rest is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.",2020,Formation of mastoid effusions during HDT is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.,['healthy subjects'],"['strict -6° head down tilt bed-rest (HDT', 'daily AG with 30 minutes continuous AG (cAG) or Intermittend AG', 'control group with no AG']","['Gravity and Mastoid effusion', 'Formation of mastoid effusions', 'mastoid effusions', 'cranial magnetic resonance images (MRI']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0242683', 'cui_str': 'Head-Down Tilt'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C2609130', 'cui_str': 'Mastoid effusion'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",,0.0531499,Formation of mastoid effusions during HDT is not prevented by daily 30 minutes short-arm intermittent or continuous centrifugation.,"[{'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Lecheler', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany. Electronic address: leopold.lecheler@dlr.de.'}, {'ForeName': 'Freia', 'Initials': 'F', 'LastName': 'Paulke', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Sonnow', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Hannover Medical School, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Limper', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany; Department of Anesthesiology and Intensive Care Medicine, Merheim Medical Center, Hospitals of Cologne, University of Witten/Herdecke, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schwarz', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Jansen', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Germany.'}, {'ForeName': 'Jens Peter', 'Initials': 'JP', 'LastName': 'Klussmann', 'Affiliation': 'University of Cologne, Medical Faculty, Department of Otorhinolaryngology, Head and Neck Surgery, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Tank', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'DLR-German Aerospace Center, Institute for Aerospace Medicine, Cologne, Germany.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.09.020']
1304,33120207,Longitudinal interrelationships of mental health discrimination and stigma with housing and well-being outcomes in adults with mental illness and recent experience of homelessness.,"RATIONALE
Stigma and discrimination are negatively associated with social and health status. People who are homeless often experience systemic stigma and discrimination.
OBJECTIVE
In this study, we analyze the longitudinal interrelationships between the trajectories of housing (housing stability) and well-being outcomes (i.e., recovery, quality of life, and community functioning) and the trajectories of discrimination and stigma in a sample of adults with mental illness and recent experiences of homelessness in Toronto, Canada. We also examined the effect of the Housing First (HF) intervention on these interrelationships.
METHOD
The Group-Based Trajectory Model was used to estimate the interrelationship (or intersections) between discrimination and stigma with housing stability, recovery, quality of life, and community functioning in 274 participants of the At Home/Chez Soi, phase 2, Toronto site randomized trial over a two-year follow-up period.
RESULTS
Three distinct trajectory groups were observed for discrimination (Low,Moderate decrease, and moderate increase), stigma (Low, Moderate, and High), recovery (Low, Moderate, and High), and the quality of life (Low, Moderate, and High). Two-trajectory groups (Low and High) were identified for housing stability and community functioning. The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability. The HF intervention had a mitigating effect on the changes across select trajectory groups, particularly for members of the Low and High discrimination and stigma trajectories group.
CONCLUSION
Persistent mental health-related discrimination and stigma trajectories are longitudinally and contemporaneously interrelated with housing and well-being outcomes in persons experiencing mental illness and recent homelessness. These findings indicate the need for interventions and actions to reduce stigma toward thispopulation. Such interventions may improve housing stability, quality of life, mental health recovery, and community functioning.",2020,"The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability.","['274 participants of the At Home/Chez Soi, phase 2, Toronto site randomized trial over a two-year follow-up period', 'adults with mental illness and recent experiences of homelessness in Toronto, Canada', 'adults with mental illness and recent experience of homelessness', 'persons experiencing mental illness and recent homelessness', 'People who are homeless often experience systemic stigma and discrimination']","['Housing First (HF) intervention', 'HF intervention']","['trajectories of housing (housing stability) and well-being outcomes (i.e., recovery, quality of life, and community functioning) and the trajectories of discrimination and stigma', 'housing stability, recovery, quality of life, and community functioning ability', 'discrimination (Low,Moderate decrease, and moderate increase), stigma (Low, Moderate, and High), recovery (Low, Moderate, and High), and the quality of life (Low, Moderate, and High', 'housing stability, quality of life, mental health recovery, and community functioning']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0676803', 'cui_str': 'Styrene-oxide isomerase'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4505046', 'cui_str': 'Mental Health Recovery'}]",274.0,0.0382565,"The analyses showed that the trajectory groups for discrimination and stigma are strongly and contemporaneously interrelated with thetrajectory groups for housing stability, recovery, quality of life, and community functioning ability.","[{'ForeName': 'Cilia', 'Initials': 'C', 'LastName': 'Mejia-Lancheros', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada. Electronic address: Cilia.Mejia-Lancheros@unityhealth.to.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lachaud', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Woodhall-Melnik', 'Affiliation': 'Department of Social Sciences, Faculty of Arts, University of New Brunswick, Saint John, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Division of General Internal Medicine, Department of Medicine, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.""}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113463']
1305,33120238,Classification of renal tumour using convolutional neural networks to detect oncocytoma.,"PURPOSE
To investigate the ability of convolutional neural networks (CNNs) to facilitate differentiation of oncocytoma from renal cell carcinoma (RCC) using non-invasive imaging technology.
METHODS
Data were collected from 369 patients between January 2015 and September 2018. True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy. The data included 20,000 2D CT images. Data were randomly divided into sets for training (70 %), validation (10 %) and independent testing (20 %, DataTest_1). A small dataset (DataTest_2) was used for additional validation of the training model. Data were divided into sets at the patient level, rather than by individual image. A modified version of the ResNet50V2 was used. Accuracy of detecting benign or malignant renal mass was evaluated by a 51 % majority vote of individual image classifications to determine the classification for each patient.
RESULTS
Test results from DataTest_1 indicate an area under the curve (AUC) of 0.973 with 93.3 % accuracy and 93.5 % specificity. Results from DataTest_2 indicate an AUC of 0.946 with 90.0 % accuracy and 98.0 % specificity when evaluation is performed image by image. There is no case in which multiple false negative images originate from the same patient. When evaluated with 51 % majority of scans for each patient, the accuracy rises to 100 % and the incidence of false negatives falls to zero.
CONCLUSION
CNNs and deep learning technology can classify renal tumour masses as oncocytoma with high accuracy. This diagnostic method could prevent overtreatment for patients with renal masses.",2020,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"['Data were collected from 369 patients between January 2015 and September 2018', 'patients with renal masses']","['convolutional neural networks (CNNs', 'CNNs and deep learning technology']","['Accuracy of detecting benign or malignant renal mass', 'accuracy rises', 'area under the curve (AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",369.0,0.020162,True labelling of scans as benign or malignant was determined by subsequent histological findings post-surgery or ultrasound-guided percutaneous biopsy.,"[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Pedersen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: mikkped@ruc.dk.'}, {'ForeName': 'Michael Brun', 'Initials': 'MB', 'LastName': 'Andersen', 'Affiliation': 'Department of Radiology, Herlev-Gentofte University Hospital, Herlev Ringvej 75, 2700, Herlev, Denmark. Electronic address: michael.brun.andersen@regionh.dk.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Christiansen', 'Affiliation': 'Department of People and Technology (DPT), Roskilde University Universitetsvej 1, 4000, Roskilde, Denmark. Electronic address: henning@ruc.dk.'}, {'ForeName': 'Nessn H', 'Initials': 'NH', 'LastName': 'Azawi', 'Affiliation': 'Department of Urology, Zealand University Hospital, Roskilde, Department of Clinical Medicine, Copenhagen University, Sygehusvej 10, 4000, Roskilde, Denmark. Electronic address: nesa@regionsjaelland.dk.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109343']
1306,33120301,"Analgesic efficacy of ketamine and magnesium after laparoscopic sleeve gastrectomy: A randomized, double-blind, placebo-controlled trial.","Background Ketamine and magnesium are antagonists of the N-methyl-d-aspartate receptor, and are valuable adjuvants for multimodal analgesia and opioid sparing. Data are limited regarding the opioid sparing efficacy of the combined intraoperative application of these agents in laparoscopic bariatric surgery. The objective of this study was to compare the postoperative opioid sparing properties of a single intraoperative dose of ketamine versus a combination of single doses of ketamine and magnesium after laparoscopic gastric sleeve resection in bariatric patients. Methods One hundred and twenty- six patients were randomly assigned to receive single boluses of ketamine alone 0.5 mg kg -1 IV (ketamine group); combined ketamine bolus of 0.5 mg kg -1 IV and magnesium 2 g IV (ketamine and magnesium group); or placebo. Opioid consumption at 24 h (in morphine equivalents); pain at rest; postoperative nausea and vomiting impact score; sedation scores; and trends of transcutaneous carbon-di-oxide values were analysed. Results The median (inter-quartile range [range]) morphine consumption at 24 h were 32 (24-47 [4.8-91]) mg in the ketamine group, 37 (18-53 [1-144]) mg in the ketamine and magnesium group, and 26 (21-36 [5-89]) mg in the control group and were not significantly different between the groups. There were no differences for all other outcomes examined. Conclusion Combined single intraoperative bolus doses of ketamine and magnesium did not result in postoperative opioid sparing after laparoscopic gastric sleeve resection.",2020,morphine consumption at 24 h were 32,"['after laparoscopic gastric sleeve resection', 'bariatric patients', 'Methods One hundred and twenty- six patients', 'after laparoscopic sleeve gastrectomy', 'consumption at 24\xa0h were 32']","[' Ketamine and magnesium', 'laparoscopic gastric sleeve resection', 'ketamine', 'ketamine alone 0.5\xa0mg\xa0kg -1 IV (ketamine group); combined ketamine bolus of 0.5\xa0mg\xa0kg -1 IV and magnesium 2\xa0g IV (ketamine and magnesium group); or placebo', 'placebo', 'ketamine and magnesium', 'morphine']","['Opioid consumption', 'nausea and vomiting impact score; sedation scores', 'transcutaneous carbon-di-oxide values', 'Analgesic efficacy', 'postoperative opioid sparing']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C4758637', 'cui_str': 'Gastric sleeve'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0007009', 'cui_str': 'Carbon'}, {'cui': 'C0030015', 'cui_str': 'Oxides'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}]",126.0,0.636448,morphine consumption at 24 h were 32,"[{'ForeName': 'Sanjib Das', 'Initials': 'SD', 'LastName': 'Adhikary', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America. Electronic address: sadhikary@pennstatehealth.psu.edu.'}, {'ForeName': 'Venkatesan', 'Initials': 'V', 'LastName': 'Thiruvenkatarajan', 'Affiliation': 'The Queen Elizabeth Hospital, Department of Anaesthesia, The University of Adelaide, Woodville South, SA 5011, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McFadden', 'Affiliation': 'St. Claire Hospital, Department of Anesthesiology, 1000 Bower Hill Rd, Pittsburgh, PA 15243, United States of America.'}, {'ForeName': 'Wai Man', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'Research School of Finance, Actuarial Studies and Statistics, Australian National University, Canberra ACT 0200, Australian Capital Territory, Australia.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Mets', 'Affiliation': 'Penn State Hershey Medical Center, Department of Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rogers', 'Affiliation': 'Penn State Hershey Medical Center, Surgical Weight Loss Program, Penn State College of Medicine, 500 University Drive, Hershey, PA 17033, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110097']
1307,33120302,Ketamine vs. haloperidol for prevention of cognitive dysfunction and postoperative delirium: A phase IV multicentre randomised placebo-controlled double-blind clinical trial.,"STUDY OBJECTIVE
Delirium is frequently observed in the postoperative and intensive care unit (ICU) population. Due to the multifactorial origin of delirium and according to international guidelines (e.g., American Geriatrics Society; Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption (PADIS) guideline), there are several but no incontestable options for prevention and symptomatic treatment. The purpose of the Baden PRIDe (Prevention and Reduction of Incidence of postoperative Delirium) trial was to determine whether postoperative cognitive dysfunction and delirium could be prevented by the combination of possible preventive agents such as haloperidol and ketamine. In addition, pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β were measured to investigate their dynamics in delirious and non-delirious patients after surgery.
DESIGN
The Baden PRIDe Trial was an investigator-initiated, phase IV, two-centre, randomised, placebo-controlled, double-blind clinical trial.
SETTING
Perioperative care.
PATIENTS
182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia.
INTERVENTIONS
Pre-anaesthetic, pharmacologic prevention of postoperative brain dysfunction with haloperidol, ketamine, and the combination of both vs. placebo.
MEASUREMENTS
Assessment of cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay.
MAIN RESULTS
None of the three study arms - haloperidol, ketamine, or both drugs combined - was significantly superior to placebo for prevention of postoperative brain dysfunction and delirium (P = 0.39). Measured levels of postoperative cortisol were significantly higher in delirious patients. S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
CONCLUSIONS
The study results offer no possibility for a novel recommendation for prevention of postoperative cognitive decline including delirium. Perioperative S-100β trajectories in patients with cognitive deterioration suggest affection of glial cells in particular.
TRIAL REGISTRATION
ClinicalTrials.govNCT02433041; registered on April 7, 2015.",2020,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","['patients with cognitive deterioration suggest affection of glial cells in particular', '182 adult patients that underwent elective or emergency surgery under general or combined (i.e., general and regional) anaesthesia']","['haloperidol, ketamine', 'Ketamine vs. haloperidol', 'haloperidol and ketamine', 'placebo', 'haloperidol, ketamine, and the combination of both vs. placebo']","['pre- and postoperative levels of the biomarkers cortisol, neuron specific enolase (NSE) and S100β', 'cognitive dysfunction and postoperative delirium', 'postoperative NSE levels', 'cognitive performance pre- and postoperatively with the MMSE, the DOS, the Nursing Delirium Screening Scale (Nu-DESC) or the Intensive Care Delirium Screening Checklist (ICDSC) during ICU stay', 'Measured levels of postoperative cortisol', 'S-100β levels', 'postoperative brain dysfunction and delirium']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854193', 'cui_str': 'Cognitive deterioration'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0202144', 'cui_str': 'Neuron-specific enolase measurement'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",182.0,0.394449,"S-100β levels were significantly higher in all postoperative outcome groups (cognitive impairment, delirium, no cognitive decline), whereas postoperative NSE levels declined in all groups.
","[{'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Hollinger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Alexa.Hollinger@usb.ch.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Rüst', 'Affiliation': 'Institute of Primary Care, University of Zurich, Pestalozzistrasse 24, 8091 Zurich, Switzerland. Electronic address: christoph.ruest@bluewin.ch.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Riegger', 'Affiliation': 'Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: HarrietYvonne.Riegger@usb.ch.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Gysi', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: bianca.gysi@stud.unibas.ch.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Tran', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: fabian.tran@stud.unibas.ch.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Brügger', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jonas.bruegger@stud.unibas.ch.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Huber', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: jan.huber@vtxmail.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Toft', 'Affiliation': 'Department for Anaesthesia, Intensive Care and Emergency Medicine, See-Spital, Horgen and Kilchberg Branches, Asylstrasse 19, 8810 Horgen, Switzerland. Electronic address: Katharina.Toft@gmail.com.'}, {'ForeName': 'Madlen', 'Initials': 'M', 'LastName': 'Surbeck', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: madlen.surbeck@stud.unibas.ch.'}, {'ForeName': 'Hans-Ruedi', 'Initials': 'HR', 'LastName': 'Schmid', 'Affiliation': 'Central Laboratory, Cantonal Hospital Baden, Im Ergel 1, 5404 Baden, Switzerland. Electronic address: Hans-Ruedi.Schmid@ksb.ch.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rentsch', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department of Clinical Chemistry and Laboratory Medicine, Petersgraben 4, 4031 Basel, Switzerland. Electronic address: Katharina.Rentsch@usb.ch.'}, {'ForeName': 'Luzius', 'Initials': 'L', 'LastName': 'Steiner', 'Affiliation': 'Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland; Department for Anesthesia, Prehospital Emergency Medicine and Pain Therapy, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland. Electronic address: Luzius.Steiner@usb.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siegemund', 'Affiliation': 'Intensive Care Unit, University Hospital Basel, Spitalstrasse 21, 4031 Basel, Switzerland; Department of Clinical Research, University of Basel, Schanzenstrasse 55, 4031 Basel, Switzerland. Electronic address: Martin.Siegemund@usb.ch.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110099']
1308,33129990,Rationale and design of the TAILOR-PCI digital study: Transitioning a randomized controlled trial to a digital registry.,"BACKGROUND
Tailored Antiplatelet Initiation to Lessen Outcomes Due to Decreased Clopidogrel Response after Percutaneous Coronary Intervention (TAILOR-PCI) is the largest cardiovascular genotype-based randomized pragmatic trial (NCT#01742117) to evaluate the role of genotype-guided selection of oral P2Y 12 inhibitor therapy in improving ischemic outcomes after PCI. The trial has been extended from the original 12- to 24-month follow-up, using study coordinator-initiated telephone visits. TAILOR-PCI Digital Study tests the feasibility of extending the trial follow-up in a subset of patients for up to 24 months using state-of-the-art digital solutions. The rationale, design, and approach of extended digital study of patients recruited into a large, international, multi-center clinical trial has not been previously described.
METHODS
A total of 930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls. Eureka, a direct-to-participant digital research platform, is used to consent and collect prospective data on patients for the digital study. Patients are asked to answer health-related surveys at fixed intervals using the Eureka mobile app and or desktop platform. The likelihood of patients enrolled in a randomized clinical trial transitioning to a registry using digital technology, the reasons for nonparticipation and engagement rates are evaluated. To capture hospitalizations, patients may optionally enable geofencing, a process that allows background location tracking and triggering of surveys if a hospital visit greater than 4 hours is detected. In addition, patients answer digital hospitalization surveys every month. Hospitalization data received from the Digital Study will be compared to data collected from study coordinator telephone visits during the same time frame.
CONCLUSIONS
The TAILOR-PCI Digital Study evaluates the feasibility of transitioning a large multicenter randomized clinical trial to a digital registry. The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials. Such a digital approach may be especially pertinent in the era of COVID-19.",2020,The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials.,"['percutaneous coronary intervention (PCI', 'subset of patients for up to 24 months using state-of-the-art digital solutions', 'patients recruited into a large, international, multi-center clinical trial', '930 patients from U.S. and Canadian sites previously enrolled in the 5,302 patient TAILOR-PCI trial within 23 months of randomization are invited by mail to the Digital Study website (http://tailorpci.eurekaplatform.org) and by up to 2 recruiting telephone calls']",['/Introduction'],['ischemic outcomes'],"[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",[],"[{'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",930.0,0.0692651,The study could provide evidence for the ability of digital technology to follow clinical trial patients and to ascertain trial-related events thus also building the foundation for conducting digital clinical trials.,"[{'ForeName': 'Naveen L', 'Initials': 'NL', 'LastName': 'Pereira', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN. Electronic address: pereira.naveen@mayo.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Avram', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Derek Y', 'Initials': 'DY', 'LastName': 'So', 'Affiliation': 'University of Ottawa Heart Institute, Ottawa, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Iturriaga', 'Affiliation': 'National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Lennon', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Vishakantha', 'Initials': 'V', 'LastName': 'Murthy', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Geller', 'Affiliation': 'National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Toronto, and Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.""}, {'ForeName': 'Charanjit', 'Initials': 'C', 'LastName': 'Rihal', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rosenberg', 'Affiliation': 'National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Bethesda, MD.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Bailey', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Pletcher', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Marcus', 'Affiliation': 'University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter\xa0Munk\xa0Cardiac Centre, Toronto, Canada.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Olgin', 'Affiliation': 'University of California San Francisco, San Francisco, CA. Electronic address: Jeffrey.olgin@ucsf.edu.'}]",American heart journal,['10.1016/j.ahj.2020.10.069']
1309,33130093,"Does intensity really matter regarding aerobic exercise reductions in wave reflection and central hemodynamics? Commentary on ""The effect of acute aerobic exercise on central arterial stiffness, wave reflection and hemodynamics in adults with diabetes: A randomized cross-over design"" by Way et al.",,2020,,['adults with diabetes'],['acute aerobic exercise'],"['central arterial stiffness, wave reflection and hemodynamics']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}]",,0.0689343,,"[{'ForeName': 'Wendell Arthur', 'Initials': 'WA', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Postgraduate in Physical Education Program, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa 87020-900, Brazil.'}, {'ForeName': 'João Carlos', 'Initials': 'JC', 'LastName': 'Locatelli', 'Affiliation': 'Postgraduate in Physical Education Program, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa 87020-900, Brazil. Electronic address: joao17_carlos@hotmail.com.'}, {'ForeName': 'Caroline Ferraz', 'Initials': 'CF', 'LastName': 'Simões', 'Affiliation': 'Department of Physical Education, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Postgraduate in Physical Education Program, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil; Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa 87020-900, Brazil.'}, {'ForeName': 'Rogério Toshiro Passos', 'Initials': 'RTP', 'LastName': 'Okawa', 'Affiliation': 'Research Group on Systemic Arterial Hypertension, Arterial Stiffness and Vascular Aging (GPHARV), Maringa 87020-900, Brazil; Department of Medicine, Center of Health Sciences, State University of Maringa, Maringa 87020-900, Brazil.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.10.008']
1310,33131460,Influence of countermovement depth on the countermovement jump-derived reactive strength index modified.,"This study aimed to investigate the effect of countermovement depth on the magnitude of the countermovement jump (CMJ) derived reactive strength index modified (RSI mod ), and to compare the RSI mod between the CMJ performed with a self-preferred knee flexion angle (CMJ pref ) and the CMJ performed from a pre-determined knee flexion angle (CMJ refer ) with the countermovement depth more similar to the CMJ pref . Sixteen subjects (11 males and 5 females; age 25.1 ± 6.3 years, body mass 69.7 ± 10.2 kg, body height 172.9 ± 8.1 m) randomly performed in a single session the CMJ pref and CMJs from five pre-determined knee flexion angles (60°, 75°, 90°, 105°, and 120°). Our results showed that lower knee flexion angles were generally associated with greater RSI mod values with the CMJ performed at 60° showing the greatest RSI mod ( P ≤ 0.049; effect size [ES] range = 0.19-0.63). The greatest RSI mod for the CMJ performed at 60° was caused by the proportionally lower values of the time to take-off (ES range = 0.65-1.91) compared to the decrease observed in jump height (ES range = 0.11-0.25). The RSI mod was higher for the CMJ pref compared to the CMJ refer ( P < 0.001; ES = 0.34) due to a higher jump height ( P = 0.021; ES = 0.14) and reduced time to take-off ( P < 0.001; ES = 0.85). These results indicate that practitioners should be careful when interpreting an individual's changes in RSI mod when the countermovement depth is not similar across the testing sessions. However, since the use of pre-determined knee flexion angles negatively impacts the RSI mod , we encourage practitioners to use the CMJ pref but only compare the RSI mod when CMJs are performed using consistent countermovement depths. Highlights The magnitude of the countermovement jump-reactive reactive strength index modified is influenced by the knee flexion angle instruction. The magnitude of the countermovement jump-reactive reactive strength index tended to progressively increase with lower amounts of knee flexion. The magnitude of the countermovement jump-reactive reactive strength index is lower when an external reference is used to control the depth of the countermovement.",2020,The RSI mod was higher for the CMJ pref compared to the CMJ refer ( P <0.001; ES=0.34) due to a higher jump height ( P =0.021; ES=0.14) and reduced time to take-off ( P <0.001; ES=0.85).,"['Sixteen subjects (11 males and 5 females; age 25.1±6.3 years, body mass 69.7±10.2 kg, body height 172.9±8.1 m']",[],"['RSI mod', 'knee flexion angles']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",[],"[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0179744,The RSI mod was higher for the CMJ pref compared to the CMJ refer ( P <0.001; ES=0.34) due to a higher jump height ( P =0.021; ES=0.14) and reduced time to take-off ( P <0.001; ES=0.85).,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez-Castilla', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Weakley', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Campus University, Brisbane, Australia.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García-Pinillos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'Rojas', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Amador', 'Initials': 'A', 'LastName': 'García-Ramos', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1845815']
1311,33096222,A randomized trial of an editorial intervention to reduce spin in the abstract's conclusion of manuscripts showed no significant effect.,"OBJECTIVE
To estimate the effect of an intervention compared to the usual peer-review process on reducing spin in the abstract's conclusion of biomedical study reports.
STUDY DESIGN AND SETTING
We conducted a two-arm, parallel-group RCT in a sample of primary research manuscripts submitted to BMJ Open. The authors received short instructions alongside the peer reviewers' comments in the intervention group. We assessed the presence of spin (primary outcome), types of spin, and wording change in the revised abstract's conclusion. Outcome assessors were blinded to the intervention assignment.
RESULTS
Of the 184 manuscripts randomized, 108 (54 intervention, 54 control) were selected for revision and could be evaluated for the presence of spin. The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54). The wording of the revised abstract's conclusion was changed in 34/54 (63%) manuscripts in the intervention group and 26/54 (48%) in the control group. The four prespecified types of spin involved (i) selective reporting (12 in the intervention group vs. 8 in the control group), (ii) including information not supported by evidence (9 vs. 9), and (iii) interpretation not consistent with the study results (14 vs. 18), and (iv) unjustified recommendations for practice (5 vs. 11).
CONCLUSION
These short instructions to authors did not have a statistically significant effect on reducing spin in revised abstract conclusions, and based on the confidence interval, the existence of a large effect can be excluded. Other interventions to reduce spin in reports of original research should be evaluated.
STUDY REGISTRATION
osf.io/xnuyt.",2020,"The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54).","['Of the 184 manuscripts randomised, 108 (54 intervention, 54 control']",['editorial intervention'],['proportion of manuscripts with spin'],"[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0600659', 'cui_str': 'Manuscripts'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282412', 'cui_str': 'Editorial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0600659', 'cui_str': 'Manuscripts'}]",,0.0946132,"The proportion of manuscripts with spin was 6% lower (95% CI: 24% lower to 13% higher) in the intervention group (57%, 31/54) than in the control group (63%, 34/54).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Ghannad', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands; Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France. Electronic address: m.ghannad@amsterdamumc.nl.'}, {'ForeName': 'Bada', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Leeflang', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aldcroft', 'Affiliation': 'BMJ, London, UK.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Schroter', 'Affiliation': 'BMJ, London, UK.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'Université de Paris, CRESS, INSERM, INRA, F-75004 Paris, France.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.10.014']
1312,33099054,"A randomised controlled trial of metacognitive training for psychosis, depression, and belief flexibility.","BACKGROUND
Metacognitive training (MCT) has been shown to be effective in reducing psychotic symptoms, including delusions. However, less is known on whether MCT, or its specific modules, are effective in ameliorating reasoning biases e.g. belief flexibility. As inflexibility in appraisal has been associated with psychosis and major depressive disorder (MDD), this study examined the efficacy of a 4-session MCT on delusions, depression, and belief flexibility, in two clinical groups (Psychosis and Depression).
METHODS
This study adopted a single-blind randomised controlled design, with patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition. The MCT intervention consisted of specific modules targeting belief flexibility. Participants were assessed before and after treatment, and at 1- and 6-month follow-ups.
RESULTS
Among the 113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT. There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group. Symptom improvements following MCT were of large effect sizes, were significantly greater than TAU, and persisted at 6-month. Belief flexibility also improved in both groups, although changes were smaller in size and were not significantly greater than TAU.
LIMITATIONS
An active control condition was not included.
CONCLUSIONS
This study demonstrated large and stable symptom reductions in delusions and depression, and smaller (yet stable) improvement in belief flexibility across groups, following a 4-session MCT, carrying implications for transdiagnostic process-based interventions and their mechanisms of change.",2020,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","['patients with schizophrenia spectrum disorders (and delusions) and patients with MDD being randomised, respectively, into the MCT condition or a treatment-as-usual (TAU) condition', '113 participants, 27 patients with psychosis and 29 patients with MDD attended MCT']","['MCT', 'Metacognitive training (MCT', 'metacognitive training']","['Belief flexibility', 'depressive symptoms', 'psychotic symptoms, especially delusions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0011253', 'cui_str': 'Delusions'}]",27.0,0.0534335,"There were significant improvements in psychotic symptoms, especially delusions, for the Psychosis group, and in depressive symptoms for the MDD group.","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ho-Wai So', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR. Electronic address: shwso@psy.cuhk.edu.hk.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Hoi-Kei Chan', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, 11 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Cheris', 'Initials': 'C', 'LastName': 'Kit-Wa Wong', 'Affiliation': 'Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Wing-Ka Ching', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Sze-Wai Lee', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Chi-Wing Wong', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Kin-Hei Chung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Alyse Yu', 'Initials': 'AY', 'LastName': 'Hung', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, 3/F Wong Foo Yuan Building, Shatin, N.T., Hong Kong SAR.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Oi-Yin Wong', 'Affiliation': 'Castle Peak Hospital, 15 Tsing Chung Koon Road, Tuen Mun, Hong Kong SAR.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sau-Man Chan', 'Affiliation': 'Department of Psychiatry, The Chinese University of Hong Kong, Tai Po Hospital, 9 Chuen On Road, Tai Po, N.T., Hong Kong SAR.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.126']
1313,33099083,Selfhood triumvirate: From phenomenology to brain activity and back again.,"Recently, a three-dimensional construct model for complex experiential Selfhood has been proposed (Fingelkurts, Fingelkurts, & Kallio-Tamminen, 2016b,c). According to this model, three specific subnets (or modules) of the brain self-referential network (SRN) are responsible for the manifestation of three aspects/features of the subjective sense of Selfhood. Follow up multiple studies established a tight relation between alterations in the functional integrity of the triad of SRN modules and related to them three aspects/features of the sense of self; however, the causality of this relation is yet to be shown. In this article we approached the question of causality by exploring functional integrity within the three SRN modules that are thought to underlie the three phenomenal components of Selfhood while these components were manipulated mentally by experienced meditators in a controlled and independent manner. Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG). This EEG-data was complemented by first-person phenomenological reports and standardised questionnaires which focused on subjective contents of three aspects of Selfhood. The results of the study strengthen the case for a direct causative relationship between three phenomenological aspects of Selfhood and related to them three modules of the brain SRN. Furthermore, the putative integrative model of the dynamic interrelations among three modules of the SRN has been proposed.",2020,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).",[],"['mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG']",[],[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",[],,0.0183146,"Participants were requested, in a block-randomised manner, to mentally induce states representing either increased (up-regulation) or decreased (down-regulation) sense of (a) witnessing agency (""Self""), or (b) body representational-emotional agency (""Me""), or (c) reflective/narrative agency (""I""), while their brain activity was recorded by an electroencephalogram (EEG).","[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland. Electronic address: andrew.fingelkurts@bm-science.com.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fingelkurts', 'Affiliation': 'BM-Science - Brain and Mind Technologies Research Centre, Espoo, Finland.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Kallio-Tamminen', 'Affiliation': 'Physics Foundations Society and Society for Natural Philosophy, Helsinki, Finland.'}]",Consciousness and cognition,['10.1016/j.concog.2020.103031']
1314,33099092,Back foot influence on dorsiflexion using three different positions of the weight bearing lunge test.,"OBJECTIVES
To determine whether back foot (BF) position influences dorsiflexion range of motion (DFROM) during three different positions of the weight bearing lunge test (WBLT).
DESIGN
Randomised, repeated measures design.
SETTING
Sports clubs.
PARTICIPANTS
52 athletes participating in cutting and pivoting sports.
MAIN OUTCOME MEASURES
DFROM was obtained using a WBLT in three different BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB). All measurements were obtained using three methods: inclinometer at the tibial tuberosity, toe to wall distance and goniometer angle from the lateral malleolus to the fibula head. Differences between testing positions were determined using a repeated measures one-way ANOVA and reliability analysis was performed using the Intraclass Correlation Coefficient (ICC).
RESULTS
DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001). These results were associated with large effect sizes for all BF positions and measurement techniques. Reliability ICC values were excellent for all measurements (ICC 0.94-0.99).
CONCLUSIONS
Results show that DFROM differs depending upon the position of the BF during the WBLT. Further research is needed to establish the reproducibility of these three BF positions due to the variability observed.",2020,"RESULTS
DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","['Sports clubs', '52 athletes participating in cutting and pivoting sports']",[],"['BF positions: BF heel in full contact with the floor, BF heel raised off the floor and BF was non weight bearing (NWB', 'DFROM', 'back foot (BF) position influences dorsiflexion range of motion (DFROM', 'Reliability ICC values']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}]",[],"[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",52.0,0.0302354,"RESULTS
DFROM was statistically significantly different for all three positions of the WBLT for each measurement technique (P < .001).","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Cady', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK; School of Life and Medical Sciences, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK. Electronic address: k.cady2@herts.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Ste Croix', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deighan', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Oxstalls Campus, Oxstalls Lane, Gloucester, GL2 9HW, UK.'}]",Physical therapy in sport : official journal of the Association of Chartered Physiotherapists in Sports Medicine,['10.1016/j.ptsp.2020.10.005']
1315,33099189,Do the metrics matter? An experimental investigation of Instagram influencer effects on mood and body dissatisfaction.,"Instagram is saturated with content from 'influencers', users who create high-quality idealised content, attain celebrity-level following, and often leverage their popularity to earn money through brand partnership/promotion. Although existing literature generally indicates the negative impact of idealised Instagram imagery on female psychological wellbeing, influencer imagery has yet to receive thorough attention. We investigated the impact of high versus low popularity influencer images on mood and body dissatisfaction. Adult women (N = 111, aged 17-40) were randomly allocated to one of three groups: either (1) the influencer-high group (idealised imagery alongside high 'like'/follow metrics); (2) the influencer-low group (the same idealised imagery adjusted for low popularity metrics); or (3) a nature control group with matched low-popularity metrics. Results revealed significantly higher negative mood and body dissatisfaction within the two influencer imagery groups compared with the control group. Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction. The findings suggest that users should be aware of the potentially negative impacts of viewing idealised influencer imagery, regardless of whether the content is high or low in popularity.",2020,"Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction.","['Adult women (N = 111, aged 17-40']","[""influencer-high group (idealised imagery alongside high 'like'/follow metrics); (2) the influencer-low group (the same idealised imagery adjusted for low popularity metrics); or (3) a nature control group with matched low-popularity metrics""]","['negative mood and body dissatisfaction', 'mood and body dissatisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}]",111.0,0.0293242,"Interestingly, comparisons revealed no significant differences between the influencer-high and influencer-low groups on mood and body dissatisfaction.","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Lowe-Calverley', 'Affiliation': 'University of Tasmania, Australia. Electronic address: Emily.Lowe@utas.edu.au.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'University of Tasmania, Australia. Electronic address: Rachel.Grieve@utas.edu.au.'}]",Body image,['10.1016/j.bodyim.2020.10.003']
1316,33117131,Effects of rTMS Treatment on Cognitive Impairment and Resting-State Brain Activity in Stroke Patients: A Randomized Clinical Trial.,"Background
Repetitive transcranial magnetic stimulation (rTMS) has been employed for motor function rehabilitation for stroke patients, but its effects on post-stroke cognitive impairment (PSCI) remains controversial.
Objective
To identify the effects of rTMS intervention on PSCI patients and its potential neural correlates to behavioral improvements.
Methods
We recruited 34 PSCI patients for 20 sessions of 10 Hz rTMS or no-stim control treatments over the left dorsal lateral prefrontal cortex (DLPFC). Cognitive function was evaluated with the Montreal Cognitive Assessment Scale, Victoria Stroop Test, Rivermead Behavior Memory Test, and Activities of Daily Living (ADL) assessed with the Modified Barthel Index. 14 patients received functional MRI scan, a useful non-invasive technique of determining how structurally segregated and functionally specialized brain areas were interconnected, which was reflected by blood oxygenation level-dependent signals. The amplitude of low-frequency fluctuation (ALFF) and functional connectivity (FC) were applied as the analytical approaches, which were used to measure the resting-state brain activity and functional connection.
Results
rTMS improved cognitive functions and ADLs for PSCI patients relative to patients who received no-stim control treatment. The cognitive improvements correlated to increased ALFF of the left medial prefrontal cortex, and increased FC of right medial prefrontal cortex and right ventral anterior cingulate cortex.
Conclusion
10 Hz rTMS at DLPFC could improve cognitive function and quality of life for PSCI patients, which is associated with an altered frontal cortical activity.
Clinical Registration
Chinese Clinical Trial Registry, ChiCTR-IPR-17011908, http://www.chictr.org.cn/index.aspx.",2020,"Results
rTMS improved cognitive functions and ADLs for PSCI patients relative to patients who received no-stim control treatment.","['stroke patients', '14 patients received', 'Stroke Patients', '34 PSCI patients for 20 sessions of 10 Hz rTMS or no-stim control treatments over the left dorsal lateral prefrontal cortex (DLPFC']","['rTMS intervention', 'functional MRI scan', 'rTMS', '\n\n\nRepetitive transcranial magnetic stimulation (rTMS']","['ALFF of the left medial prefrontal cortex, and increased FC of right medial prefrontal cortex and right ventral anterior cingulate cortex', 'cognitive functions and ADLs', 'Montreal Cognitive Assessment Scale, Victoria Stroop Test, Rivermead Behavior Memory Test, and Activities of Daily Living (ADL', 'cognitive function and quality of life', 'Cognitive function', 'amplitude of low-frequency fluctuation (ALFF) and functional connectivity (FC', 'Cognitive Impairment and Resting-State Brain Activity']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",34.0,0.0254229,"Results
rTMS improved cognitive functions and ADLs for PSCI patients relative to patients who received no-stim control treatment.","[{'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuanwen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lingrong', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Radiology, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yinan', 'Initials': 'Y', 'LastName': 'Ai', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiquan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Rehabilitation Medicine, The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}]",Frontiers in neural circuits,['10.3389/fncir.2020.563777']
1317,33120324,The effects of the Fordyce's 14 fundamentals for happiness program on happiness and caregiver burden among the family caregivers of patients with epilepsy: A randomized controlled trial.,"BACKGROUND
Caregiving to patients with epilepsy (PWE) is often very stressful for family caregivers and puts a heavy caregiver burden (CB) on them. The aim of this study was to evaluate the effects of Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE.
METHODS
This randomized controlled trial was conducted on seventy family caregivers of PWE. Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran, and randomly allocated to either an intervention or a control group. Participants in the control group received conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions. Happiness and CB in both groups were assessed at three time points, namely before, immediately after, and two months after the intervention. Data were analyzed using the SPSS program (v. 18.0).
FINDINGS
There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05). The mean scores of happiness and CB in the control group did not significantly change (P > 0.05), while the mean score of happiness significantly increased and the mean score of CB significantly decreased in the intervention group across the three measurement time points (P < 0.05). Consequently, the mean score of happiness in the intervention group was significantly greater than the control group and the mean score of CB in the intervention group was significantly less than the control group at both posttests (P < 0.01).
CONCLUSION
The Fordyce's fourteen Fundamentals for Happiness Program is effective in significantly increasing happiness and reducing CB among the family caregivers of PWE. Healthcare providers and policy makers can use this program to reduce problems among these family caregivers.",2020,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"['Participants were purposively recruited from the Comprehensive Health Center in Shahrekord, Iran', ""Fordyce's fourteen Fundamentals for Happiness Program on happiness and CB among the family caregivers of PWE"", 'patients with epilepsy (PWE', 'seventy family caregivers of PWE', 'family caregivers of patients with epilepsy']","['happiness program', ""conventional health-related educations in four one-hour group sessions, while participants in the intervention group received the Fordyce's fourteen Fundamentals for Happiness Program in eight one-hour group sessions""]","['mean scores of happiness and CB', 'happiness and caregiver burden', 'mean score of happiness', 'mean score of CB', 'Happiness and CB']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0221218', 'cui_str': ""Fordyce's disease""}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",70.0,0.0376502,There were no significant differences between the control and the intervention groups regarding participants' demographic characteristics and their pretest mean scores of happiness and CB (P > 0.05).,"[{'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Rabiei', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: Leila_rabiei@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Lotfizadeh', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoud_lotfizadeh@yahoo.com.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Karimi', 'Affiliation': 'Social Determinants of Health Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: zzkkarimmi@gmail.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Masoudi', 'Affiliation': 'Community-Oriented Nursing Midwifery Research Center, Shahrekord University of Medical Sciences, Shahrekord, Iran. Electronic address: masoodi1383@yahoo.com.'}]",Seizure,['10.1016/j.seizure.2020.10.013']
1318,33128325,Trial of Rivaroxaban in AntiPhospholipid Syndrome (TRAPS): Two-year outcomes after the study closure.,"BACKGROUND
Trial of Rivaroxaban in AntiPhospholipid Syndrome was a prospective randomized, open-label, noninferiority study conducted in 14 centers in Italy. Rivaroxaban was compared with warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk, triple-positive patients with antiphospholipid syndrome.
OBJECTIVE
The aim of this paper is to report the events during the 2-year follow-up after the study closure.
METHODS
On January 28, 2018, the trial was prematurely stopped by adjudication and safety committee for an excess of events in the rivaroxaban group. Randomized patients were advised on trial results and those randomized to rivaroxaban were solicited to switch to warfarin. All 14 participating centers were asked and accepted to follow their patients for clinical events. This report describes the rate of events that occurred between January 28, 2018, and January 28, 2020.
RESULTS
Of 120 randomized patients, 115 were available for follow-up. Outcome events were two in six (33.3%) patients who remained on direct oral anticoagulants (DOACs) and six in 109 (5.7%) patients on warfarin (hazard ratio [HR] 6.9; 95% confidence interval [CI] 1.4-34.5, P = .018). The two patients on DOACs (one taking dabigatran and one taking rivaroxaban) suffered from thromboembolic events, whereas of the six patients with composite outcomes on warfarin, three had thromboembolic events (HR for thrombosis 13.3; 95% CI 2.2-79.9, P = .005).
CONCLUSION
These data further support the use of warfarin in high-risk patients with antiphospholipid syndrome.",2020,"Rivaroxaban was compared to warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk triple-positive patients with antiphospholipid syndrome.
","['120 randomized patients', '14 centres in Italy', 'AntiPhospholipid Syndrome (TRAPS', 'high-risk patients with APS']","['rivaroxaban', 'Rivaroxaban', 'warfarin']","['thromboembolic events, major bleeding, and vascular death', 'thromboembolic events']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid syndrome'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",120.0,0.0654754,"Rivaroxaban was compared to warfarin for the prevention of thromboembolic events, major bleeding, and vascular death in high-risk triple-positive patients with antiphospholipid syndrome.
","[{'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Pengo', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac Thoracic and Vascular Sciences, and Public Health, University of Padova, Padova, Italy.'}, {'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Hoxha', 'Affiliation': 'Internal Medicine, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Andreoli', 'Affiliation': 'Rheumatology and Clinical Immunology ASST-Spedali Civili di Brescia, Department of Clinical and Experimental Science, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Tincani', 'Affiliation': 'Rheumatology and Clinical Immunology ASST-Spedali Civili di Brescia, Department of Clinical and Experimental Science, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Silvestri', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Prisco', 'Affiliation': 'Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Fierro', 'Affiliation': 'Section of Internal and Cardiovascular Medicine, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Gresele', 'Affiliation': 'Section of Internal and Cardiovascular Medicine, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Cafolla', 'Affiliation': 'Department of Translational and Precision Medicine and Hematology, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'De Micheli', 'Affiliation': 'UOS Haemostasis and Thrombosis - Internal Medicine, ASST, Lecco, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ghirarduzzi', 'Affiliation': 'Angiology Unit, Department of Internal Medicine, Santa Maria Nuova Hospital, Reggio Emilia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Tosetto', 'Affiliation': 'Hematology Department, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Falanga', 'Affiliation': 'Department of Immunohematology and Transfusion Medicine and Hemostasis and Thrombosis Center, Hospital Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Martinelli', 'Affiliation': ""A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Testa', 'Affiliation': 'Hemostasis and Thrombosis Center, Laboratory Medicine Department, Azienda Socio-Sanitaria Territoriale, Cremona, Italy.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Barcellona', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gerosa', 'Affiliation': 'Clincal Rheumatology Unit, Research Center for Adult and Pediatric Diseases, Department of Clinical Sciences and Community Health, ASST Pini-CTO, University of Milan, Milan, Italy.'}, {'ForeName': 'Gentian', 'Initials': 'G', 'LastName': 'Denas', 'Affiliation': 'Thrombosis Research Laboratory, Department of Cardiac Thoracic and Vascular Sciences, and Public Health, University of Padova, Padova, Italy.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.15158']
1319,33128473,Borage Oil Treated with Immobilized Lipase Inhibits Melanogenesis.,"In the present study, we demonstrated that borage (Borago officinalis L.) seed oil subjected to immobilized lipase pretreatment are enriched with linoleic acid (LNA, 18:2n-6), γ-linolenic acid (GLA, 18:3n-6), and oleic acid (OLA, 18:1n-9). We further showed that lipase-treated borage oil (LT-BOL) regulates the activity and degradation of tyrosinase, an important enzyme implicated in the synthesis of melanin in murine melanocytes, B16F10. LT-BOL and its free fatty acid components reduced the levels of melanin and tyrosinase in melanocytes with GLA exerting similar or stronger effects compared with LNA and OLA. The brightening efficacy of LT-BOL on melanin metabolism in humans was tested by an 8-week, double-blind, randomized clinical trial, which enrolled 21 Korean female adults (mean age 48.57 ± 3.28). Visual evaluation showed that cream containing 1% LT-BOL significantly decreased (p < 0.05) melasma on the treated skin area after 6 and 8 weeks. The analysis of the skin brightness using Chromameter CR-400 confirmed that the brightness of the treated area was significantly increased (p < 0.01) after 4, 6, and 8 weeks. Together, our results suggest that LT-BOL may be suitable as a natural skin whitening cosmeceutical product.",2020,Visual evaluation showed that cream containing 1% LT-BOL significantly decreased (p < 0.05) melasma on the treated skin area after 6 and 8 weeks.,['21 Korean female adults (mean age 48.57 ±\u20093.28'],"['LT-BOL', 'lipase-treated borage oil (LT-BOL']","['melanin metabolism', 'LT-BOL']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0212750', 'cui_str': 'borage oil'}]","[{'cui': 'C0025196', 'cui_str': 'Melanin'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0212750', 'cui_str': 'borage oil'}]",21.0,0.120856,Visual evaluation showed that cream containing 1% LT-BOL significantly decreased (p < 0.05) melasma on the treated skin area after 6 and 8 weeks.,"[{'ForeName': 'Jin A', 'Initials': 'JA', 'LastName': 'Shin', 'Affiliation': ""Biotechnology Research Center, Ben's Lab., Co., Ltd., 17 Wauan-gil, Bongdam-eup, Hwasung-si, Gyeonggi-do, Republic of Korea.""}, {'ForeName': 'Meixiang', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': ""Biotechnology Research Center, Ben's Lab., Co., Ltd., 17 Wauan-gil, Bongdam-eup, Hwasung-si, Gyeonggi-do, Republic of Korea.""}, {'ForeName': 'Jong-Moon', 'Initials': 'JM', 'LastName': 'Jeong', 'Affiliation': 'Department of Bioscience, College of Engineering, The University of Suwon, 17 Wauan-gil, Bongdam-eup, Hwasung-si, Gyeonggi-do, Republic of Korea.'}]",Lipids,['10.1002/lipd.12266']
1320,33129628,Efficacy of a dyadic intervention to improve communication between patients with cancer and their caregivers: A randomized pilot trial.,"OBJECTIVE
Cancer-related communication is critical for patients' and caregivers' adaptation to illness. This randomized pilot study was conducted to test the feasibility, acceptability, and efficacy of a specific dyadic intervention to improve communication.
METHODS
A four weekly-session intervention was developed to reinforce cancer-related patient-caregiver communication. Patients receiving treatment for any diagnosed cancer, and their caregivers, were recruited from two oncology clinics in Belgium. Sixty-four patient-caregiver dyads were assigned randomly to intervention and waitlist groups. Cancer-related dyadic communication, dyadic coping and emotional distress were assessed at baseline and post-intervention.
RESULTS
The intervention attrition rate was 6 %. Linear mixed models were performed on 60 dyads. Significant two-way group × time interaction indicated improvement in participants' cancer-related dyadic communication frequency (β = -1.30; SE = 0.31; p = .004), self-efficacy (β = -10.03; SE = 3.90; p = .011) and dyadic coping (β = -5.93; SE = 2.73; p = .046) after the intervention.
CONCLUSION
These results indicate that the brief dyadic communication intervention is feasible and acceptable, and show preliminary evidence of efficacy.
PRACTICE IMPLICATIONS
Encouraging patients and caregivers to discuss personal cancer-related concerns may improve their ability to cope with the illness together.",2020,"This randomized pilot study was conducted to test the feasibility, acceptability, and efficacy of a specific dyadic intervention to improve communication.
","['Patients receiving treatment for any diagnosed cancer, and their caregivers, were recruited from two oncology clinics in Belgium', 'Sixty-four patient-caregiver dyads', 'patients with cancer and their caregivers']","['specific dyadic intervention', 'dyadic intervention', 'dyadic communication intervention']","[""participants' cancer-related dyadic communication frequency"", 'intervention attrition rate', 'Cancer-related dyadic communication, dyadic coping and emotional distress', 'dyadic coping', 'feasibility, acceptability, and efficacy', 'self-efficacy', 'reinforce cancer-related patient-caregiver communication']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",60.0,0.0387665,"This randomized pilot study was conducted to test the feasibility, acceptability, and efficacy of a specific dyadic intervention to improve communication.
","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Tiete', 'Affiliation': ""Université Libre de Bruxelles, Faculté des Sciences Psychologiques et de l'Education, 50 Avenue Franklin Roosevelt, Brussels, Belgium; Hôpital Erasme, Service de Psychologie, 808 Route de Lennik, Brussels, Belgium. Electronic address: julien.tiete@erasme.ulb.ac.be.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Delvaux', 'Affiliation': ""Université Libre de Bruxelles, Faculté des Sciences Psychologiques et de l'Education, 50 Avenue Franklin Roosevelt, Brussels, Belgium; Hôpital Erasme, Service de Psychologie, 808 Route de Lennik, Brussels, Belgium.""}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Liénard', 'Affiliation': ""Université Libre de Bruxelles, Faculté des Sciences Psychologiques et de l'Education, 50 Avenue Franklin Roosevelt, Brussels, Belgium; Institut Jules Bordet, Clinique de Psycho-oncologie, 121 Boulevard de Waterloo, Brussels, Belgium.""}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Razavi', 'Affiliation': ""Université Libre de Bruxelles, Faculté des Sciences Psychologiques et de l'Education, 50 Avenue Franklin Roosevelt, Brussels, Belgium; Institut Jules Bordet, Clinique de Psycho-oncologie, 121 Boulevard de Waterloo, Brussels, Belgium.""}]",Patient education and counseling,['10.1016/j.pec.2020.08.024']
1321,33130217,"Comparing nanoparticle polymeric micellar paclitaxel and solvent-based paclitaxel as first-line treatment of advanced non-small-cell lung cancer: an open-label, randomized, multicenter, phase III trial.","BACKGROUND
Polymeric micellar paclitaxel (pm-Pac) is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel. We aimed to compare the efficacy and safety between pm-Pac plus cisplatin and solvent-based paclitaxel (sb-Pac) plus cisplatin in advanced non-small-cell lung cancer (NSCLC).
PATIENTS AND METHODS
A total of 448 stage IIIB to IV NSCLC patients were randomly assigned (2:1) to receive six 3-week cycles of either pm-Pac (230 mg/m 2 ) plus cisplatin (70 mg/m 2 ; n = 300), followed by dose escalation of pm-Pac to 300 mg/m 2 from the second 3-week cycle if prespecified toxic effects were not observed after the first cycle, or sb-Pac (175 mg/m 2 ) plus cisplatin (70 mg/m 2 ; n = 148). The primary end point was objective response rate (ORR) assessed by independent review committees (IRCs). The secondary end points included IRC-assessed progression-free survival (PFS), overall survival (OS), and safety.
RESULTS
Patients in the pm-Pac-plus-cisplatin group showed significant improvements in IRC-assessed ORR compared with those in the sb-Pac-plus-cisplatin group (50% versus 26%; rate ratio 1.91; P < 0.0001). Additionally, subgroup analysis showed that a higher ORR was consistently observed in both squamous and nonsquamous histological types. IRC-assessed median PFS was significantly higher in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group (6.4-month versus 5.3-month; hazard ratio 0.63; P = 0.0001). Median OS was not significantly different between the two groups. The incidence of treatment-related serious adverse events (9% versus 18%; P = 0.0090) was significantly lower in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group.
CONCLUSION
Pm-Pac plus cisplatin yielded superior ORR and PFS along with a favorable safety profile and should become an option for patients with advanced NSCLC.
CLINICAL TRIAL IDENTIFIER
ClinicalTrials.gov NCT02667743; https://clinicaltrials.gov/ct2/show/NCT02667743.",2020,"The incidence of treatment-related serious adverse events (9% vs. 18%; p=0.0090) was significantly lower in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group.
","['patients with advanced NSCLC', 'advanced non-small cell lung cancer (NSCLC', '448 stage IIIB to IV NSCLC patients', 'Advanced', 'Non-Small Cell Lung Cancer']","['Nanoparticle Polymeric Micellar Paclitaxel and Solvent-based Paclitaxel', 'cisplatin', 'paclitaxel', 'pm-Pac-plus-cisplatin', 'sb-Pac-plus-cisplatin', 'pm Pac plus cisplatin and sb-Pac (solvent-based paclitaxel) plus cisplatin', 'Polymeric micellar paclitaxel (pm-Pac', 'pm-Pac']","['IRC-assessed progression-free survival (PFS), overall survival (OS), and safety', 'objective response rate (ORR) assessed by independent review committees (IRC', 'efficacy and safety', 'ORR', 'incidence of treatment-related serious adverse events', 'IRC-assessed ORR', 'Median OS', 'IRC-assessed median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}]","[{'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0037638', 'cui_str': 'Solvent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",448.0,0.144124,"The incidence of treatment-related serious adverse events (9% vs. 18%; p=0.0090) was significantly lower in the pm-Pac-plus-cisplatin group than in the sb-Pac-plus-cisplatin group.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gu', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic Oncology, Fujian Cancer Hospital, The Affiliated Cancer Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Henan Cancer Hospital, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Chemotherapy, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Pneumology, Anhui Provincial Hospital, The First Affiliated Hospital of USTC, Hefei, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Oncology, Jiangsu Province Hospital, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Tianjin Union Medical Centre, Tianjin, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Tumor Chemotherapy, Yunnan Cancer Hospital, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Center, Kunming, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Hubei Cancer Hospital, Wuhan, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Medical Oncology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Pneumology, Shanghai East Hospital, The Affiliated East Hospital of Tongji University, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Shantou Central Hospital, Affiliated Shantou Hospital of Sun Yat-Sen University, Shantou, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Henan Provincial Chest Hospital, Zhengzhou, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Pneumology, The Affiliated Zhongshan Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, Puyang Oilfield General Hospital, Puyang, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Qinghai University, Xining, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Yizhong Biotechnical Co., Ltd., Shanghai, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China. Electronic address: hanxkyy@aliyun.com.'}, {'ForeName': 'Y L', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China. Electronic address: syylwu@live.cn.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.10.479']
1322,33130236,Oncology patients were found to understand and accept the Trials within Cohorts design.,"BACKGROUND AND OBJECTIVE
The Trials within Cohorts design aims to reduce recruitment difficulties and disappointment bias in pragmatic trials. On cohort enrollment, broad informed consent for randomization is asked, after which cohort participants can be randomized to interventions or serve as controls without further notification. We evaluated patients' recollection, understanding, and acceptance of broad consent in a clinical oncology setting.
METHODS
We surveyed 610 patients with cancer participating in ongoing TwiCs; 482 patients (79%) responded, of which 312 patients shortly after cohort enrollment, 108 patients after randomization to an intervention (12-18 months after cohort enrollment), and a random sample of 62 cohort participants who had not been selected for interventions (1-6 months after cohort enrollment).
RESULTS
Shortly after providing cohort consent, 76% of patients (238/312) adequately remembered whether they had given broad consent for randomization. Of patients randomly offered interventions, 76% (82/108) remembered giving broad consent for randomization; 41% (44/108) understood they were randomly selected, 44% (48/108) were not interested in selection procedures, and 10% (11/108) did not understand selection was random. Among patients not selected for interventions, 42% (26/62) understood selection was random; 89% felt neutral regarding the scenario of ""not being selected for an intervention while your data were being used in comparison with patients receiving interventions,"" 10% felt reassured (6/62) and 2% scared/insecure (2/62).
CONCLUSION
Patients adequately remember giving broad consent for randomization shortly after cohort enrollment and after being offered an intervention, but recollection is lower in those never selected for interventions. Patients are acceptant of serving as control without further notifications.",2020,"Of patients randomly offered interventions, 76% (n=82/108) remembered giving broad consent for randomization; 41% (n=44/108) understood they were randomly selected, 44% (n=48/108) were not interested in selection procedures and 10% (n=11/108) did not understand selection was random.","['610 patients with cancer participating in ongoing TwiCs cohorts; 482 patients responded (79%), of which 312 patients shortly after cohort enrollment, 108 patients after randomization to an intervention (12-18 months after cohort enrollment), and a random sample of 62 cohort-participants who had not been selected for interventions (1-6 months after cohort enrollment']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",[],[],610.0,0.130457,"Of patients randomly offered interventions, 76% (n=82/108) remembered giving broad consent for randomization; 41% (n=44/108) understood they were randomly selected, 44% (n=48/108) were not interested in selection procedures and 10% (n=11/108) did not understand selection was random.","[{'ForeName': 'Danny A', 'Initials': 'DA', 'LastName': 'Young-Afat', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, The Netherlands. Electronic address: d.a.youngafat@umcutrecht.nl.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Gerlich', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Johannes P M', 'Initials': 'JPM', 'LastName': 'Burbach', 'Affiliation': 'Department of Surgery, University Medical Center, Groningen, The Netherlands.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'van der Velden', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Desireé H J G', 'Initials': 'DHJG', 'LastName': 'van den Bongard', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Martijn P W', 'Initials': 'MPW', 'LastName': 'Intven', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Nicolien', 'Initials': 'N', 'LastName': 'Kasperts', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rieke', 'Initials': 'R', 'LastName': 'van der Graaf', 'Affiliation': 'Department of Medical Humanities, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Carla H', 'Initials': 'CH', 'LastName': 'van Gils', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands; Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, The Netherlands; Utrecht University, Utrecht, The Netherlands.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.10.015']
1323,33131199,"Favorable effect of sodium-glucose cotransporter 2 inhibitor, dapagliflozin, on non-alcoholic fatty liver disease compared with pioglitazone.","AIMS/INTRODUCTION
Sodium-glucose cotransporter 2 inhibitors, as well as thiazolidines, suppress nonalcoholic fatty liver disease (NAFLD); however, few comparative studies have been reported. Dapagliflozin has shown non-inferiority compared with pioglitazone for glycemic control, and superiority regarding weight reduction in patients with type 2 diabetes. We carried out a secondary analysis for the favorable effects of sodium-glucose cotransporter inhibitors for NAFLD.
MATERIALS AND METHODS
In this multicenter, open-label, prospective, randomized, parallel-group comparison trial, patients taking pioglitazone for ≥12 weeks were randomly switched to dapagliflozin or continued pioglitazone for a further 24 weeks. The fatty liver index (FLI), consisting of body mass index, triglycerides, waist circumference and γ-glutamyl transpeptidase, was used for the evaluation of NAFLD.
RESULTS
A total of 53 participants with NAFLD (27 dapagliflozin; 26 pioglitazone) were included in this analysis. FLI decreased significantly in the dapagliflozin group (48.7 ± 23.4 to 42.1 ± 23.9) compared with the pioglitazone group (49.0 ± 26.1 to 51.1 ± 25.8; P < 0.01). Multiple linear regression analysis showed that the changes in FLI had a significantly positive correlation with changes in glycated hemoglobin (P = 0.03) and insulin level (P < 0.01) in the dapagliflozin group.
CONCLUSION
Dapagliflozin might be more beneficial than pioglitazone in patients with NAFLD. Improvements in FLI would be closely related to glycemic control.",2020,Dapagliflozin has demonstrated non-inferiority compared with pioglitazone for glycemic control and superiority regarding weight reduction in patients with type 2 diabetes.,"['patients with NAFLD', 'patients with type 2 diabetes', 'Fifty-three participants with NAFLD (27 dapagliflozin; 26']","['sodium-glucose co-transporter-2 inhibitor dapagliflozin', 'SGLT2 inhibitors', 'dapagliflozin or continued pioglitazone', 'pioglitazone', 'Dapagliflozin', 'Sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'dapagliflozin']","['nonalcoholic fatty liver disease', 'Fatty liver index (FLI), consisting of body mass index, triglycerides, waist circumference, and γ-glutamyl transpeptidase', 'FLI', 'insulin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",53.0,0.043359,Dapagliflozin has demonstrated non-inferiority compared with pioglitazone for glycemic control and superiority regarding weight reduction in patients with type 2 diabetes.,"[{'ForeName': 'Kyu Yong', 'Initials': 'KY', 'LastName': 'Cho', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Akinobu', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kazuno', 'Initials': 'K', 'LastName': 'Omori', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Takase', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Aika', 'Initials': 'A', 'LastName': 'Miya', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nomoto', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hiraku', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Taneda', 'Affiliation': 'Diabetes Center, Manda Memorial Hospital, Sapporo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Kurihara', 'Affiliation': 'Kurihara Clinic, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Aoki', 'Affiliation': 'Aoki Clinic, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}]",Journal of diabetes investigation,['10.1111/jdi.13457']
1324,33139136,Repeated exposure to an MF-59 adjuvanted quadrivalent subunit influenza vaccine (aQIV) in children: Results of two revaccination studies.,"BACKGROUND
Pediatric adjuvanted seasonal influenza vaccines induce higher immune responses and have the potential to confer better protection against influenza among young vaccine-naïve children. Limited data describe benefits and risks of repeated administration of adjuvanted influenza vaccines in children. Two revaccination studies assess the safety and immunogenicity of repeated exposure to an MF59-adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®) compared to routine non-adjuvanted quadrivalent influenza vaccine (QIV).
METHODS
Children previously enrolled in the parent study, who received vaccination with aQIV or nonadjuvanted influenza vaccine (TIV or QIV), were recruited in Season 1 (n = 607) or Season 2 (n = 1601) of the extension trials. Season 1 participants remained in their original randomization groups (aQIV-aQIV or TIV-QIV); Season 2 subjects were re-randomized to either vaccine, resulting in four groups (aQIV-aQIV, aQIV-QIV, QIV-aQIV, or QIV-QIV). All subjects received a single-dose vaccination. Blood samples were taken for immunogenicity assessment prior to vaccination and 21 and 180 days after vaccination. Reactogenicity (Days 1-7) and safety were assessed in all subjects.
RESULTS
Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2. Higher HI titers against heterologous influenza strains were observed after aQIV vaccination during both seasons. Mild to moderate severity and short duration reactogenicity was more common in the aQIV than QIV groups, but the overall safety profiles were similar to the parent study.
CONCLUSION
The safety and immunogenicity results from this study demonstrate benefit of aQIV for both priming and revaccination of children aged 12 months to 7 years.",2020,"RESULTS
Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2.","['children', 'children aged 12\xa0months to 7\xa0years', 'Children previously enrolled in the parent study, who received vaccination with aQIV or nonadjuvanted influenza vaccine (TIV or QIV), were recruited in Season 1 (n\xa0=\xa0607) or Season 2 (n\xa0=\xa01601) of the extension trials', 'young vaccine-naïve children']","['MF-59 adjuvanted quadrivalent subunit influenza vaccine (aQIV', 'routine non-adjuvanted quadrivalent influenza vaccine (QIV', 'vaccine', 'adjuvanted influenza vaccines', 'MF59-adjuvanted quadrivalent influenza vaccine (aQIV; Fluad®']","['overall safety profiles', 'Reactogenicity', 'Mild to moderate severity and short duration reactogenicity', 'Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0574482', 'cui_str': 'Tiv language'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0289787', 'cui_str': 'MF59 oil emulsion'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0769254,"RESULTS
Hemagglutination inhibition (HI) geometric mean titer (GMT) ratios demonstrated superiority of aQIV revaccination over QIV revaccination for all strains in Season 1 and for A/H1N1, B/Yamagata, and B/Victoria in Season 2.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Nordic Research Network Oy, Tampere, Finland. Electronic address: timo.vesikari@gmail.com.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ramsey', 'Affiliation': 'Jordan Ridge Kids & Teens, West Jordan, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pitisuttithum', 'Affiliation': 'Mahidol University, Department of Clinical Tropical Medicine, Bangkok, Thailand.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Muntinlupa, Philippines.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Heijnen', 'Affiliation': 'Janssen Vaccines & Prevention B.V., Leiden, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Sawlwin', 'Affiliation': 'Seqirus Australia Pty Ltd, Parkville, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Oberyé', 'Affiliation': 'Seqirus Netherlands BV, Clinical Science and Strategy, Amsterdam, The Netherlands.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Seqirus Inc, Clinical Science and Strategy, Cambridge, USA.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Seqirus Inc, Clinical Science and Strategy, Cambridge, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.10.036']
1325,33141065,Airflow dynamics and exhaled-breath temperature following cold-water ingestion.,"INTRODUCTION
Drinking cold water evokes decreases in spirometric indices of lung function. We studied whether this could be explained by changes in exhaled-breath temperature (EBT), airflow dynamics, and spirometer measurement sensitivity.
METHODS
In a randomized/crossover design, 10 healthy adults consumed 1000 mL refrigerated water (2.1 ± 0.64 °C) or water at room temperature (19.4 ± 0.5 °C), with EBT assessed at baseline and at 5, 10, 15 and 30-min post-ingestion. The influence of EBT on pneumotachograph measurement characteristics was modelled using computational fluid dynamics (CFD).
RESULTS
At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion. At a flow of 8 L s -1 , a decrease in EBT of 2.1 °C (as observed following cold-water ingestion) was modelled to underpredict lung volume by 0.7%.
CONCLUSIONS
Cold water reduces EBT below baseline but effects pneumotachograph measurements only negligibly. Therefore, decreased lung function following cold-water ingestion likely has a physiological explanation which warrants further study.",2020,"At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion.","['10 healthy adults consumed 1000 mL refrigerated water (2.1 ± 0.64 °C) or water at room temperature (19.4 ± 0.5 °C), with EBT assessed at baseline and at 5, 10, 15 and 30-min post-ingestion']",['EBT'],"['exhaled-breath temperature (EBT), airflow dynamics, and spirometer measurement sensitivity', 'EBT', 'spirometric indices of lung function', 'lung function', 'Airflow dynamics and exhaled-breath temperature']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C4517470', 'cui_str': '0.64'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0225387', 'cui_str': 'Exhaled air'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0183441', 'cui_str': 'Spirometer'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",10.0,0.0478814,"At 5-min post-ingestion, EBT was lower (p < 0.001) following the ingestion of cold water versus water at room-temperature (31.7 ± 1.1 vs. 33.0 ± 0.9 °C), and remained lower until 30-min post-ingestion.","[{'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Tiller', 'Affiliation': 'Institute of Respiratory Medicine and Exercise Physiology, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States. Electronic address: nicholas.tiller@lundquist.org.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Turner', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hart', 'Affiliation': 'Centre for Sports Engineering Research, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Institute of Respiratory Medicine and Exercise Physiology, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA, United States.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103564']
1326,33141078,"Aquatic exercise improves functional capacity, perceptual aspects, and quality of life in older adults with musculoskeletal disorders and risk of falling: A randomized controlled trial.","BACKGROUND
This study aimed to determine the effects of an aquatic training program on functional capacity, perceptual aspects, and quality of life (QoL) performed by older adults with musculoskeletal disorders (MSDs) and moderate/high risk of falls.
METHODS
This randomized controlled trial included 120 older adults assigned to aquatic exercises (AG; n = 60; 70.62 ± 6.04 years) and a control group (CG; n = 60; 71.86 ± 6.95 years). The risk of falls, perceptual aspects (fall risk awareness and pain), functional capacity (lower and upper body strength, lower and upper body flexibility, functional mobility, and balance) and QoL were assessed at baseline and after the experimental protocol. The AG performed 16 weeks of aquatic exercises (twice per week, 45 min.session -1 ) with lower and upper body strength, stretching, and balance exercises. Exercise intensity was controlled using the rate of perceived exertion (12-16 on the Borg scale [6-20 points]) and heart rate (progressing from 40% to 60% of the heart-rate reserve).
RESULTS
The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
CONCLUSIONS
The water-based program may be used as a preventive approach for the older adults with MSDs and at risk of falling to improve physical and usual perceptual aspects (QoL and pain) and fall risk awareness.",2020,"The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
","['120 older adults assigned to', 'older adults with musculoskeletal disorders (MSDs) and moderate/high risk of falls', 'older adults with musculoskeletal disorders and risk of falling', 'older adults with MSDs']","['aquatic training program', 'aquatic exercises', 'Aquatic exercise']","['risk of falls, perceptual aspects (fall risk awareness and pain), functional capacity (lower and upper body strength, lower and upper body flexibility, functional mobility, and balance) and QoL', 'Exercise intensity', 'fall risk awareness', 'functional capacity, perceptual aspects, and quality of life (QoL', 'functional capacity, perceptual aspects, and quality of life', 'pain perception', 'heart rate', 'QoL perception', 'upper body flexibility', 'functional mobility', 'upper body strength', 'rate of perceived exertion']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0026857', 'cui_str': 'Disorder of musculoskeletal system'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",120.0,0.0368855,"The training program improved the lower (mean difference [95% CI]: 2.7 [2.0 to 3.3]) and upper body strength (3.5 [2.6 to 4.5]), lower (4.6 [3.4 to 5.8]) and upper body flexibility (6.5 [4.3 to 8.6]), functional mobility (-2.5 [-2.9 to -1.9]), and balance (11.2 [10.6 to 11.9]); reduced pain perception (-3.2 [-3.7 to -2.8]); increased the fall risk awareness (9.5 [8.8 to 10.1]) and QoL perception (5.6 to 22.6 [4.6 to 25.1]).
","[{'ForeName': 'Natália Boneti', 'Initials': 'NB', 'LastName': 'Moreira', 'Affiliation': 'Department of Physiotherapy, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: nataliamoreira@ufpr.br.'}, {'ForeName': 'Letícia Pophal', 'Initials': 'LP', 'LastName': 'da Silva', 'Affiliation': 'Department of Physical Education, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: leticiapophal@ufpr.br.'}, {'ForeName': 'André Luiz Felix', 'Initials': 'ALF', 'LastName': 'Rodacki', 'Affiliation': 'Department of Physical Education, Federal University of Paraná, Setor de Ciências Biológicas, Curitiba, Paraná, Brazil. Electronic address: rodacki@ufpr.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111135']
1327,33239746,Efficacy and safety of once-monthly Risperidone ISM ® in schizophrenic patients with an acute exacerbation.,"To evaluate the efficacy and safety of Risperidone ISM ® against placebo in patients with acute exacerbation of schizophrenia. A multicenter, randomized, double-blind, placebo-controlled study was conducted between June 2017 and December 2018 (NCT03160521). Eligible patients received once-monthly intramuscular injections of Risperidone ISM ® (75 or 100 mg) or placebo for 12 weeks. The primary efficacy outcome was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 12. The key secondary efficacy outcome was change from baseline in Clinical Global Impressions-Severity of Illness scale (CGI-S) score. Altogether, 438 patients were randomized (1:1:1) and 390 included in the modified ITT efficacy set. The PANSS total score (mean difference, 95% CI) improved significantly from baseline to day 85 with Risperidone ISM ® 75 and 100 mg, with placebo-adjusted differences of -13.0 (95% CI, -17.3 to -8.8); (p < 0.0001), and -13.3 (-17.6 to -8.9); (p < 0.0001), respectively. Significantly improved mean changes were also obtained for CGI-S score from baseline to day 85 for both doses of Risperidone ISM ® compared with placebo -0.7 (-1.0 to -0.5); p < 0.0001, for both doses. The statistically significant improvement for both efficacy outcomes were observed as early as 8 days after first injection. The most frequently reported treatment-emergent adverse events were increased blood prolactin (7.8%), headache (7.3%), hyperprolactinemia (5%), and weight increase (4.8%). Neither new nor unexpected relevant safety information was recorded. Risperidone ISM ® provided rapid and progressive reduction of symptoms in patients with acutely exacerbated schizophrenia without need of oral risperidone supplementation or loading doses. Both doses were safe and well tolerated.",2020,"Significantly improved mean changes were also obtained for CGI-S score from baseline to day 85 for both doses of Risperidone ISM ® compared with placebo -0.7 (-1.0 to -0.5); p < 0.0001, for both doses.","['438 patients were randomized (1:1:1) and 390 included in the modified ITT efficacy set', 'patients with acute exacerbation of schizophrenia', 'schizophrenic patients with an acute exacerbation', 'patients with acutely exacerbated schizophrenia']","['Risperidone ISM ®', 'Risperidone ISM ® against placebo', 'placebo']","['safe and well tolerated', 'change in Positive and Negative Syndrome Scale (PANSS) total score', 'hyperprolactinemia', 'Efficacy and safety', 'Clinical Global Impressions-Severity of Illness scale (CGI-S) score', 'efficacy and safety', 'blood prolactin', 'CGI-S score', 'efficacy outcomes', 'weight increase', 'PANSS total score', 'headache']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0272203', 'cui_str': 'Indolent systemic mastocytosis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020514', 'cui_str': 'Hyperprolactinemia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0853129', 'cui_str': 'Blood prolactin'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]",438.0,0.266665,"Significantly improved mean changes were also obtained for CGI-S score from baseline to day 85 for both doses of Risperidone ISM ® compared with placebo -0.7 (-1.0 to -0.5); p < 0.0001, for both doses.","[{'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, NY, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Litman', 'Affiliation': 'CBH Health LLC, Gaithersburg, MD, USA.'}, {'ForeName': 'Yuriy', 'Initials': 'Y', 'LastName': 'Filts', 'Affiliation': 'Communal Noncommercial Enterprise of Lviv Regional Council, Lviv Regional Clinical Psychiatric Hospital, Lviv, Ukraine.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Llaudó', 'Affiliation': 'Medical Department, Laboratorios Farmacéuticos ROVI, S.A, Madrid, Spain.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Naber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Hamburg-Eppendorf University, Hamburg, Germany.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics core facility, Clinical Pharmacology Department, IDIBAPS-Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martínez', 'Affiliation': 'Medical Department, Laboratorios Farmacéuticos ROVI, S.A, Madrid, Spain. jmartinez@rovi.es.'}]",NPJ schizophrenia,['10.1038/s41537-020-00127-y']
1328,33107490,Effect of zinc supplementation on relative expression of immune response genes in neonates with sepsis: A preliminary study.,"Background & objectives
Zinc alters gene expression mainly by binding to a site on the transcription factor. Genome-wide expression studies have shown early repression of genes related to zinc and immunity in adult patients with sepsis. The present study was conducted to evaluate the role of zinc supplementation on relative expression of immune response genes in neonatal sepsis.
Methods
In the present study, a sample of convenience of 22 neonates each was selected from the zinc supplemented and control groups using random numbers for expression of immune-related genes by zinc supplementation. These neonates with sepsis were earlier randomized into two groups: with and without zinc supplementation in addition to standard antibiotics and supportive care. Relative expression of immune response genes were analyzed for 22 neonates in each group using quantitative real-time PCR for calprotectin (S100A8/A9), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), toll-like receptor-4 (TLR-4), cluster of differentiation 14 (CD14) and lipopolysaccharide-binding protein (LBP) genes.
Results
An increase in serum zinc levels was observed in zinc-supplemented group compared to controls. S100A8 gene showed downregulation by three-fold (P <0.001) and S100A9 gene showed upregulation by two-fold (P <0.05) in zinc group compared to controls. CD14 gene showed upregulation by one-fold in zinc-supplemented group compared to controls (P <0.05). No significant fold changes were observed with respect to TNF-α, IL-6, LBP and TLR-4 genes between the two groups.
Interpretation & conclusions
The results of our preliminary study showed that the zinc supplementation might modulates the relative expression of immune-related genes involved in sepsis pathway among neonates. However, studies with larger sample size are needed to be done to provide a better picture on the outcome by gene expression in neonatal sepsis by zinc supplementation.",2020,"No significant fold changes were observed with respect to TNF-α, IL-6, LBP and TLR-4 genes between the two groups.
","['neonates with sepsis', 'adult patients with sepsis', 'neonatal sepsis', 'sample of convenience of 22 neonates each was selected from the zinc supplemented and control groups using random numbers for expression of immune-related genes by zinc supplementation']","['zinc supplementation in addition to standard antibiotics and supportive care', 'zinc supplementation']","['serum zinc levels', 'TNF-α, IL-6, LBP and TLR-4 genes', 'quantitative real-time PCR for calprotectin (S100A8/A9), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), toll-like receptor-4 (TLR-4), cluster of differentiation 14 (CD14) and lipopolysaccharide-binding protein (LBP) genes', 'relative expression of immune response genes']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C1318315', 'cui_str': 'Serum zinc measurement'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0086344', 'cui_str': 'Immune response gene'}]",22.0,0.138615,"No significant fold changes were observed with respect to TNF-α, IL-6, LBP and TLR-4 genes between the two groups.
","[{'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Banupriya', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Ballambattu Vishnu', 'Initials': 'BV', 'LastName': 'Bhat', 'Affiliation': 'Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Vinayagam', 'Initials': 'V', 'LastName': 'Vickneshwaran', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}, {'ForeName': 'Magadi Gopalakrishna', 'Initials': 'MG', 'LastName': 'Sridhar', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_557_18']
1329,33107494,Insights from pre-treatment attrition & dropouts in an effectiveness trial of methylphenidate in children.,,2020,,['children'],['methylphenidate'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}]",[],,0.034385,,"[{'ForeName': 'Ruchita', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}, {'ForeName': 'Susanta', 'Initials': 'S', 'LastName': 'Padhy', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}, {'ForeName': 'Adarsh', 'Initials': 'A', 'LastName': 'Kohli', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}, {'ForeName': 'Samita', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Psychiatry, Postgraduate Institute of Medical Education & Research, Chandigarh 160 012, India.'}]",The Indian journal of medical research,['10.4103/ijmr.IJMR_1498_18']
1330,33104729,Familiarity with teammate's attitudes improves team performance in virtual reality.,"Virtual reality (VR) is a potentially challenging social environment for effective communication and collaboration. Thus, we conducted a VR study to determine whether increased familiarity with a teammate would improve performance on a joint decision making task. Specifically, because attitude familiarity, or knowledge of another person's attitudes, has been correlated with better relationship functioning in the past, we anticipated that team performance would improve when teammates were first asked to discuss their task-relevant attitudes with one another. We also hypothesized that increased familiarity would be particularly useful in immersive VR, where typical social and other nonverbal cues were lacking. Twenty pairs recruited from a workplace environment were randomly assigned to either the Familiar or Control condition before completing a joint decision making task both in VR and on desktop monitors. The manipulation of attitude familiarity was successful: pairs in the Familiar condition were significantly more aware of their partners' unique task-relevant attitudes. Results found that in VR, Familiar pairs were more accurate at determining patterns to events. Additionally, for teams less experienced in VR, Familiar pairs were also more accurate at predicting future events. However, there was no meaningful statistical difference in pairs' ability to identify information. Familiar teams also took more time to answer questions, and we found no difference in self-reported communication quality. Overall, this was the first successful manipulation of attitude familiarity and results indicate that such an intervention may prove useful in a collaborative work environment, as Familiar teams demonstrated greater accuracy, especially in VR.",2020,The manipulation of attitude familiarity was successful: pairs in the Familiar condition were significantly more aware of their partners' unique task-relevant attitudes.,['Twenty pairs recruited from a workplace environment'],"['Virtual reality (VR', 'Familiar or Control condition before completing a joint decision making task both in VR and on desktop monitors']",[],"[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",[],20.0,0.0132779,The manipulation of attitude familiarity was successful: pairs in the Familiar condition were significantly more aware of their partners' unique task-relevant attitudes.,"[{'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Moore', 'Affiliation': 'U. S. Army Combat Capabilities and Development Command, U. S. Army Research Lab, Aberdeen Proving Ground, Maryland, United States of America.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Geuss', 'Affiliation': 'U. S. Army Combat Capabilities and Development Command, U. S. Army Research Lab, Aberdeen Proving Ground, Maryland, United States of America.'}]",PloS one,['10.1371/journal.pone.0241011']
1331,33104739,A randomised on-line survey exploring how health condition labels affect behavioural intentions.,"OBJECTIVES
We examined the effect of 'labels' versus 'descriptions' across four asymptomatic health conditions: pre-diabetes, pre-hypertension, mild hyperlipidaemia, and chronic kidney disease stage 3A, on participants' intentions to pursue further tests. There were four secondary objectives: 1) assessing confidence and satisfaction in their intention to test further; 2) revealing psychological drivers affecting intentions; 3) exploring whether intentions, confidence and satisfaction differ by label vs. description and health condition; and 4) producing a perceptual map of illnesses by label condition.
METHODS
Practitioner validated health-related scenarios were used. Two variants of each condition were developed. Participants were recruited through Qualtrics from Australia, Ireland and Canada and randomly assigned two 'labelled' or two 'descriptive' scenarios.
RESULTS
There was no significant difference in intentions to test between label and description conditions (95% CI -0.76 to 0.33 points, p = 0.4). Confidence and satisfaction were both positively associated with intentions: regression coefficient (β) for confidence β = 0.58 points (95% CI 0.49 to 0.68, p < .001) and for satisfaction 0.67 points (95% CI 0.57 to 0.77, p < .001). Predisposition to seek healthcare (β = 0.72; 95% CI 0.47 to 0.98), attributing illness to bad luck (β = -0.16 points; 95% CI -0.3 to -0.02), and concern about the health condition (β = 0.51; 95% CI 0.38 to 0.65) also significantly predicted intentions.
CONCLUSIONS
Unlike studies investigating symptomatic illnesses, the disease label effect on behavioural intentions was not supported suggesting that reducing demand for medical services for borderline cases cannot be achieved by labelling. The average intention to test score was higher in this sample than previous symptomatic health-related studies and there was a positive relationship between increased intentions and confidence/satisfaction in one's decision. Exploratory insights suggested perceptions of the four labelled asymptomatic illnesses all shifted toward greater levels of dread and concern compared to their respective description condition.
TRIAL REGISTRATION
ACTRN12618000392268.",2020,"Unlike studies investigating symptomatic illnesses, the disease label effect on behavioural intentions was not supported suggesting that reducing demand for medical services for borderline cases cannot be achieved by labelling.","[""Participants were recruited through Qualtrics from Australia, Ireland and Canada and randomly assigned two 'labelled' or two 'descriptive' scenarios"", 'Practitioner validated health-related scenarios were used']",[],"['Confidence and satisfaction', 'intentions to test between label and description conditions', 'confidence and satisfaction in their intention to test further; 2) revealing psychological drivers affecting intentions; 3) exploring whether intentions, confidence and satisfaction differ by label vs. description and health condition; and 4) producing a perceptual map of illnesses by label condition']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0024779', 'cui_str': 'Maps'}]",2.0,0.257868,"Unlike studies investigating symptomatic illnesses, the disease label effect on behavioural intentions was not supported suggesting that reducing demand for medical services for borderline cases cannot be achieved by labelling.","[{'ForeName': 'Rae', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Spence', 'Affiliation': 'Bond Business School, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Rajat', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Bond Business School, Bond University, Gold Coast, Australia.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Beller', 'Affiliation': 'Institute for Evidence-Based Healthcare, Bond University, Gold Coast, Australia.'}]",PloS one,['10.1371/journal.pone.0240985']
1332,33118896,The taste of biodiversity: science and sensory education with different varieties of a vegetable to promote acceptance among primary school children.,"OBJECTIVE
To determine the impact of an educational programme for primary schools that explored the biodiversity of tomato, by promoting science and sensory education with three distinct varieties of it, in the acceptance of vegetables.
DESIGN
A randomised controlled study in which children were exposed to the educational programme (intervention group) or remained in the class, as usual (control group). The educational programme consisted of three sessions where children explained the observed differences between the three varieties of tomato and individual perceptions of their flavours based on sensory-based food education and by planning and implementing experiments to explain those differences. We tested the effects on both children's willingness to try and their liking for tomato, and for lettuce and cabbage to study the carry-over effect, compared with the control group (Mann-Whitney U test; P < 0·05).
SETTING
The study took place in public primary schools in Porto, Portugal.
PARTICIPANTS
Children in the third grade (8-13-year-old children) (n 136) were randomly assigned to intervention or control group.
RESULTS
Children in the intervention group reported significant increases in their willingness to try and liking for tomato compared to the control group (P < 0·05), but not for lettuce and cabbage (P > 0·05).
CONCLUSIONS
These results highlight the potential for fostering children's acceptance of a vegetable by exploring biodiversity through science education. Further work may clarify the effects of exploring biodiversity on the consumption of vegetables and establish whether the results are stable over time and replicable across contexts and populations.",2020,"RESULTS
Children in the intervention group reported significant increases in their willingness to try and liking for tomato compared to the control group (p < 0.05), but not for lettuce and cabbage (p > 0.05).
","['public primary schools in Porto, Portugal', 'primary school children', 'Children in the third grade (8-13-year-old children) (n 136']","['intervention or control group', 'educational program (intervention group) or remained in the class, as usual (control group', 'educational program']",['willingness to try and liking for tomato'],"[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0032729', 'cui_str': 'Portugal'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517568', 'cui_str': '136'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0242772', 'cui_str': 'Tomato'}]",,0.0162802,"RESULTS
Children in the intervention group reported significant increases in their willingness to try and liking for tomato compared to the control group (p < 0.05), but not for lettuce and cabbage (p > 0.05).
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Afonso', 'Affiliation': 'Center for Psychology, Rua Alfredo Allen, 4200-135Porto, Portugal.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aboim', 'Affiliation': 'P. Porto: School of Education, Rua Dr. Roberto Frias, 602, Porto, Portugal.'}, {'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Pessoa', 'Affiliation': 'Portuguese Association of Science Education - APEduC, Rua Faria Vasconcelos, Castelo Branco, Portugal.'}, {'ForeName': 'Xana', 'Initials': 'X', 'LastName': 'Sá-Pinto', 'Affiliation': 'P. Porto: School of Education, Rua Dr. Roberto Frias, 602, Porto, Portugal.'}]",Public health nutrition,['10.1017/S1368980020004371']
1333,33113161,Effect of hyoscine-N-butylbromide on labor duration among nullipara in a southwestern Nigerian teaching hospital: A randomized controlled trial.,"OBJECTIVE
To assess the effectiveness of hyoscine-N-butylbromide on the duration of the first stage of labor among nulliparous women.
METHODS
A randomized double-blind placebo-controlled study among 126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018. Based on the inclusion criteria, women were recruited and randomized to the study or control group, and given intravenous hyoscine-N-butylbromide 20 mg (1 mL) or sterile water (1 mL), respectively, during the active phase. Labor progress and outcomes were compared between the groups.
RESULTS
The mean ± SD duration of active phase of first stage of labor was significantly shorter in the hyoscine-N-butylbromide group (324.9 ± 134.6 min) than in the control group (392.7 ± 119.6 min) (P = 0.004). The rate of cervical dilatation was 1.4 ± 0.8 cm/h in the hyoscine-N-butylbromide group and 1.0 ± 0.5 cm/h in the control group (P = 0.004). There were no significant differences in fetal heart rate, maternal vital signs, or Apgar scores between the two groups.
CONCLUSION
Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate. The trial was registered with the Pan African Clinical trials Registry (PACTR), protocol number: PACTR201808146688942 (https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3532).",2020,Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate.,"['nulliparous women', '126 nulliparous women admitted in the active phase of labor to a teaching hospital in Sagamu, Nigeria, from January to August 2018', 'labor duration among nullipara in a southwestern Nigerian teaching hospital']","['hyoscine-N-butylbromide 20\xa0mg (1\xa0mL) or sterile water', 'placebo', 'hyoscine-N-butylbromide', 'Hyoscine-N-butylbromide']","['fetal heart rate, maternal vital signs, or Apgar scores', 'mean\xa0±\xa0SD duration of active phase of first stage of labor', 'rate of cervical dilatation']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor'}, {'cui': 'C0028641', 'cui_str': 'Nulliparity'}, {'cui': 'C1556089', 'cui_str': 'Nigerians'}]","[{'cui': 'C0006519', 'cui_str': 'Scopolamine butylbromide'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}]",126.0,0.242392,Hyoscine-N-butylbromide was found to be effective in shortening the duration of the first stage of labor without adverse outcomes for mother or neonate.,"[{'ForeName': 'Adeniyi K', 'Initials': 'AK', 'LastName': 'Akiseku', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University, Ago Iwoye, Nigeria.'}, {'ForeName': 'Olusoji E', 'Initials': 'OE', 'LastName': 'Jagun', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}, {'ForeName': 'Adebayo A', 'Initials': 'AA', 'LastName': 'Akadri', 'Affiliation': 'Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital, Ilishan-Remo, Nigeria.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'Imaralu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Babcock University Teaching Hospital, Ilishan-Remo, Nigeria.'}, {'ForeName': 'Adetola O', 'Initials': 'AO', 'LastName': 'Olatunji', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}, {'ForeName': 'Adewale O', 'Initials': 'AO', 'LastName': 'Sule-Odu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Olabisi Onabanjo University Teaching Hospital, Sagamu, Nigeria.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13444']
1334,33113196,Efficacy of Multi-Layered Soft Silicone: A Randomized Clinical Trial.,,2020,,[],['Multi-Layered Soft Silicone'],[],[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}]",[],,0.169638,,"[{'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Mendonça Moraes', 'Affiliation': ''}, {'ForeName': 'Rhea S A', 'Initials': 'RSA', 'LastName': 'Soares', 'Affiliation': ''}, {'ForeName': 'Thais D', 'Initials': 'TD', 'LastName': 'Eberhardt', 'Affiliation': ''}, {'ForeName': 'Lidiana B T D', 'Initials': 'LBTD', 'LastName': 'Silveira', 'Affiliation': ''}, {'ForeName': 'Paulo J P', 'Initials': 'PJP', 'LastName': 'Alves', 'Affiliation': ''}, {'ForeName': 'Suzinara', 'Initials': 'S', 'LastName': 'Beatriz Soares de Lima', 'Affiliation': ''}]",AORN journal,['10.1002/aorn.13200']
1335,33113277,"Comparison of the safety and efficacy of the on-demand use of sertraline, dapoxetine, and daily use of sertraline in the treatment of patients with lifelong premature ejaculation: A prospective randomised study.","This study compared the safety and efficacy of the on-demand (OD) use of sertraline (50 mg), sertraline (100 mg) and dapoxetine (30 mg), and the daily use of sertraline (50 mg) in the treatment of patients with premature ejaculation (PE). This prospective randomised study involved 120 lifelong PE patients (intravaginal ejaculatory latency time [IELT]: <1 min; Arabic Index of Premature Ejaculation [AIPE] score: < 30) without secondary causes of PE, identified between March 2018 and May 2020. Patients were divided into 4 groups (30 patients per group) and treated for 8 weeks. Assessments were conducted using the AIPE form as a diagnostic tool. Sertraline (50 mg, daily; 196.7 ± 115.5 s) and sertraline (100 mg, OD; 173.3 ± 97.0 s) had similar IELT and AIPE scores. The latter groups had better results in comparison with sertraline (50 mg, OD; 100.5 ± 54.4 s) and dapoxetine (93.7 ± 53.5 s; p < 0.01). Sertraline (100 mg, OD) had a similar efficacy to that of sertraline (50 mg, daily) and was more effective than sertraline (50 mg, OD) and dapoxetine (30 mg, OD). Sertraline (100 mg, OD) can be considered in the treatment of lifelong PE treatment, having tolerable side effects.",2020,"The latter groups had better results in comparison with sertraline (50 mg, OD; 100.5 ± 54.4 s) and dapoxetine (93.7 ± 53.5 s; p < 0.01).","['patients with premature ejaculation (PE', 'patients with lifelong premature ejaculation', '120 lifelong PE patients (intravaginal ejaculatory latency time [IELT]: <1\xa0min; Arabic Index of Premature Ejaculation [AIPE] score: < 30) without secondary causes of PE, identified between March 2018 and May 2020']","['dapoxetine', 'sertraline', 'Sertraline', 'sertraline, dapoxetine']","['similar IELT and AIPE scores', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",120.0,0.0291584,"The latter groups had better results in comparison with sertraline (50 mg, OD; 100.5 ± 54.4 s) and dapoxetine (93.7 ± 53.5 s; p < 0.01).","[{'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Sahan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Alkan', 'Initials': 'A', 'LastName': 'Cubuk', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Orkunt', 'Initials': 'O', 'LastName': 'Ozkaptan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Toprak', 'Affiliation': 'Department of Urology, Health Science University, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Ozcan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kasım', 'Initials': 'K', 'LastName': 'Ertas', 'Affiliation': 'Department of Urology, School of Medicine, Van Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Onder', 'Initials': 'O', 'LastName': 'Canguven', 'Affiliation': 'Department of Urology, General Hamad Hospital, Doha, Qatar.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Tarhan', 'Affiliation': 'Department of Urology, Health Science University, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}]",Andrologia,['10.1111/and.13854']
1336,33115783,"Diet-Associated Inflammation Modulates Inflammation and WNT Signaling in the Rectal Mucosa, and the Response to Supplementation with Dietary Fiber.","Inflammation drives colorectal cancer development, and colorectal cancer risk is influenced by dietary factors, including dietary fiber. Hyperactive WNT signaling occurs in colorectal cancer and may regulate inflammation. This study investigated (i) relationships between the inflammatory potential of diet, assessed using the Energy-adjusted Dietary Inflammatory Index (E-DII), and markers of WNT signaling, and (ii) whether DII status modulated the response to supplementation with two types of dietary fiber. Seventy-five healthy participants were supplemented with resistant starch and/or polydextrose (PD) or placebo for 50 days. Rectal biopsies were collected before and after intervention and used to assess WNT pathway gene expression and crypt cell proliferation. E-DII scores were calculated from food frequency questionnaire data. High-sensitivity C-reactive protein (hsCRP) and fecal calprotectin concentrations were quantified. hsCRP concentration was significantly greater in participants with higher E-DII scores [least square means (LSM) 4.7 vs. 2.4 mg/L, P = 0.03]. Baseline E-DII score correlated with FOSL1 ( β = 0.503, P = 0.003) and WNT11 ( β = 0.472, P = 0.006) expression, after adjusting for age, gender, body mass index, endoscopy procedure, and smoking status. WNT11 expression was more than 2-fold greater in individuals with higher E-DII scores (LSM 0.131 vs. 0.059, P = 0.002). Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression ( P = 0.04). More proinflammatory diets were associated with altered WNT signaling and appeared to modulate the effects of PD supplementation on expression of FOSL1 . This is the first study to investigate relationships between the E-DII and molecular markers of WNT signaling in rectal tissue of healthy individuals. PREVENTION RELEVANCE: Our finding that more inflammatory dietary components may impact large bowel health through effects on a well-recognised pathway involved in cancer development will strengthen the evidence base for dietary advice to help prevent bowel cancer.",2020,Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression (P=0.04).,"['Seventy-five healthy participants', 'rectal tissue of healthy individuals']","['PD supplementation', 'resistant starch (RS) and/or polydextrose (PD) or placebo']","['WNT11 expression', 'hsCRP concentration', 'High-sensitivity C-reactive protein (hsCRP) and faecal calprotectin concentrations', 'E-DII scores', 'Baseline E-DII score', 'FOSL1 expression']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1442821', 'cui_str': 'FOSL1 protein, human'}]",75.0,0.0442883,Baseline E-DII modulated the effects of PD supplementation on FOSL1 expression (P=0.04).,"[{'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Malcomson', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Naomi D', 'Initials': 'ND', 'LastName': 'Willis', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'McCallum', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Shivappa', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hébert', 'Affiliation': 'Department of Epidemiology and Biostatistics and Cancer Prevention and Control Program, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Betul', 'Initials': 'B', 'LastName': 'Kocaadam-Bozkurt', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Aycil', 'Initials': 'A', 'LastName': 'Özturan-Sirin', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Seamus B', 'Initials': 'SB', 'LastName': 'Kelly', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom.'}, {'ForeName': 'D Michael', 'Initials': 'DM', 'LastName': 'Bradburn', 'Affiliation': 'Northumbria Healthcare NHS Foundation Trust, Ashington, United Kingdom.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Belshaw', 'Affiliation': 'University of East Anglia, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Johnson', 'Affiliation': 'Quadram Institute, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Framlington Place, Newcastle upon Tyne, United Kingdom. john.mathers@ncl.ac.uk.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0335']
1337,33124968,Effects of Multilayer Silicone Foam Dressings for the Prevention of Pressure Ulcers in High-Risk Patients: A Randomized Clinical Trial.,"Objective: To determine whether multilayer silicone foam dressings can prevent pressure ulcers arising in the sacrum and coccyx of patients with persistent severe diarrhea and/or fragile skin. Approach: This randomized, 14-day controlled trial included 600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers. All participants were enrolled from three Japanese institutions. Participants meeting all inclusion and exclusion criteria were randomized using the Excel program to receive standard care (control; n = 300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention; n = 300). Results: Significantly more participants in the control than the intervention group developed pressure ulcers (22 vs. 5, p = 0.001). Innovation: The incidence of pressure ulcers remains high in hospitalized patients at high risk of developing pressure ulcers. The present findings might contribute to novel preventive strategies for patients at high risk of developing pressure ulcers. Conclusion: Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.",2020,Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.,"['patients with persistent severe diarrhea and/or fragile skin', 'All participants were enrolled from three Japanese institutions', '600 hospitalized patients with persistent severe diarrhea and/or fragile skin who were at high risk of developing pressure ulcers', 'High-Risk Patients', 'patients at high risk of developing pressure ulcers', 'hospitalized patients at high risk of developing pressure ulcers', 'Participants meeting all inclusion and exclusion criteria']","['multilayer silicone foam dressings', 'Excel program to receive standard care (control; n \u2009=\u2009300) recommended by Japanese guidelines or multilayer silicone foam dressings applied to the sacrum and coccyx (intervention; n \u2009=\u2009300', 'Multilayer silicone foam dressings', 'Multilayer Silicone Foam Dressings']","['Pressure Ulcers', 'pressure ulcers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C0241181', 'cui_str': 'Fragile skin'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C3164124', 'cui_str': 'Foam dressing'}, {'cui': 'C2740529', 'cui_str': 'Excel'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0036037', 'cui_str': 'Bone structure of sacrum'}, {'cui': 'C0009194', 'cui_str': 'Bone structure of coccyx'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}]",600.0,0.049254,Multilayer silicone foam dressings can prevent pressure ulcers of the sacrum and coccyx in patients with persistent severe diarrhea and/or fragile skin.,"[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Oe', 'Affiliation': 'Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Sasaki', 'Affiliation': 'Department of Nursing, The University of Tokyo Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Shimura', 'Affiliation': 'Department of Nursing, Nippon Medical School Hospital, Tokyo, Japan.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Takaki', 'Affiliation': 'Department of Nursing, Fukuseikai Hospital, Fukuoka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Sanada', 'Affiliation': 'Global Nursing Research Center, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Advances in wound care,['10.1089/wound.2019.1002']
1338,33120195,"Effect of an educational intervention delivered by pharmacists on adherence to treatment, disease control and lung function in patients with asthma.","BACKGROUND
Lack of therapeutic adherence is a relevant problem in clinical practice and it can be assessed via validated tools such as the Test of Adherence to Inhalers (TAI). Education on the correct use of inhaler devices has been associated with improvement in adherence. Many studies highlighted the pivotal role of pharmacists in promoting therapeutic adherence in the management of respiratory diseases.
OBJECTIVE
To evaluate the effectiveness on adherence and clinical parameters of an educational intervention administered by clinical pharmacists (CPs) to patients with asthma on long-term inhalation therapy.
METHODS
A prospective comparative study involving 34 community pharmacies in Italy (23 intervention, 11 control). Enrolled subjects were evaluated for adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function at baseline and after 2 months. The educational intervention at baseline was based on TAI results and administered by specifically trained pharmacists.
RESULTS
A total of 242 consecutive subjects (167 intervention, 75 control) were enrolled. There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit. Patients with baseline ACT≥20 maintained disease control more frequently in the intervention group compared to the control arm (95% vs 79.5%, p = 0.004). Conclusions through administration of TAI-driven educational interventions addressing both technical and psychological issues, trained CPs can help improve adherence to treatment and asthma control.",2020,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","['242 consecutive subjects (167 intervention, 75 control) were enrolled', '34 community pharmacies in Italy (23 intervention, 11 control', 'patients with asthma on long-term inhalation therapy', 'patients with asthma']","['educational intervention administered by clinical pharmacists (CPs', 'educational intervention']","['disease control', 'TAI score, ACT and lung function parameters', 'adherence to inhalation therapy by TAI, asthma control by ""Asthma Control Test"" (ACT), and lung function']","[{'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1449564', 'cui_str': 'Clinical pharmacist'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}]",34.0,0.0251079,"There was a significant improvement in TAI score, ACT and lung function parameters (p-value<0.001) in the intervention group between baseline and the follow-up visit.","[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Paoletti', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Keber', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Heffler', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy. Electronic address: enrico.heffler@hunimed.eu.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Malipiero', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Baiardini', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Personalized Medicine, Asthma and Allergy, Humanitas Clinical and Research Center IRCCS, Rozzano, MI, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, MI, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Giua', 'Affiliation': 'Società Italiana Farmacia Clinica (SIFAC), Cagliari, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine,['10.1016/j.rmed.2020.106199']
1339,31026118,Additive value of diffusion-weighted MRI in the I-SPY 2 TRIAL.,"BACKGROUND
The change in apparent diffusion coefficient (ADC) measured from diffusion-weighted imaging (DWI) has been shown to be predictive of pathologic complete response (pCR) for patients with locally invasive breast cancer undergoing neoadjuvant chemotherapy.
PURPOSE
To investigate the additive value of tumor ADC in a multicenter clinical trial setting.
STUDY TYPE
Retrospective analysis of multicenter prospective data.
POPULATION
In all, 415 patients who enrolled in the I-SPY 2 TRIAL from 2010 to 2014 were included.
FIELD STRENGTH/SEQUENCE
1.5T or 3T MRI system using a fat-suppressed single-shot echo planar imaging sequence with b-values of 0 and 800 s/mm2 for DWI, followed by a T1-weighted sequence for dynamic contrast-enhanced MRI (DCE-MRI) performed at pre-NAC (T0), after 3 weeks of NAC (T1), mid-NAC (T2), and post-NAC (T3).
ASSESSMENT
Functional tumor volume and tumor ADC were measured at each MRI exam; pCR measured at surgery was assessed as the binary outcome. Breast cancer subtype was defined by hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status.
STATISTICAL TESTS
A logistic regression model was used to evaluate associations between MRI predictors with pCR. The cross-validated area under the curve (AUC) was calculated to assess the predictive performance of the model with and without ADC.
RESULTS
In all, 354 patients (128 HR+/HER2-, 60 HR+/HER2+, 34 HR-/HER2+, 132 HR-/HER2-) were included in the analysis. In the full cohort, adding ADC predictors increased the AUC from 0.76 to 0.78 at mid-NAC and from 0.76 to 0.81 at post-NAC. In HR/HER2 subtypes, the AUC increased from 0.52 to 0.65 at pre-NAC for HR+/HER2-, from 0.67 to 0.73 at mid-NAC and from 0.72 to 0.76 at post-NAC for HR+/HER2+, from 0.71 to 0.81 at post-NAC for triple negatives.
DATA CONCLUSION
The addition of ADC to standard functional tumor volume MRI showed improvement in the prediction of treatment response in HR+ and triple-negative breast cancer.
LEVEL OF EVIDENCE
2 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2019;50:1742-1753.",2019,"The addition of ADC to standard functional tumor volume MRI showed improvement in the prediction of treatment response in HR+ and triple-negative breast cancer.
","['patients with locally invasive breast cancer undergoing neoadjuvant chemotherapy', '415 patients who enrolled in the I-SPY 2 TRIAL from 2010 to 2014 were included', '354 patients (128 HR+/HER2-, 60 HR+/HER2+, 34 HR-/HER2+, 132 HR-/HER2-) were included in the analysis']",[],"['Functional tumor volume and tumor ADC', 'cross-validated area under the curve (AUC', 'AUC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",415.0,0.080188,"The addition of ADC to standard functional tumor volume MRI showed improvement in the prediction of treatment response in HR+ and triple-negative breast cancer.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Newitt', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Wilmes', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Ella F', 'Initials': 'EF', 'LastName': 'Jones', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Vignesh', 'Initials': 'V', 'LastName': 'Arasu', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gibbs', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'La Yun', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Li', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}, {'ForeName': 'Savannah C', 'Initials': 'SC', 'LastName': 'Partridge', 'Affiliation': 'Department of Radiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kornak', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Quantum Leap Healthcare Collaborative, San Francisco, California, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Esserman', 'Affiliation': 'Department of Surgery, University of California, San Francisco, California, USA.'}, {'ForeName': 'Nola M', 'Initials': 'NM', 'LastName': 'Hylton', 'Affiliation': 'Department of Radiology & Biomedical Imaging, University of California, San Francisco, California, USA.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.26770']
1340,33125674,"Safety, Pharmacokinetics, and Pharmacodynamics of Globalagliatin, a Glucokinase Activator, in Chinese Patients with Type 2 Diabetes Mellitus: A Randomized, Phase Ib, 28-day Ascending Dose Study.","BACKGROUND AND OBJECTIVES
Globalagliatin, a glucokinase activator, plays a vital role in glucose homeostasis. The aim of this study was to assess the safety, pharmacokinetics, and pharmacodynamics of globalagliatin in Chinese patients with type 2 diabetes.
METHODS
In this dose-titration study, 24 patients were randomized (3:1 ratio) to receive globalagliatin or placebo. The 28-day titration was divided into two stages, each comprising 12 subjects. In stage I (low-dose), globalagliatin or placebo was administered at ascending doses of 20, 40, 80, and 120 mg once daily, increased at weekly intervals. As the treatment was well tolerated, stage II (high-dose) was initiated, with ascending doses of 80, 160, 240, and 320 mg. Safety, pharmacokinetic and pharmacodynamic analysis were conducted.
RESULTS
Following once-daily titration with ascending doses of globalagliatin of 20-120 mg (stage I) and 80-320 mg (stage II) for 7 days, globalagliatin caused mildly high incidences of hypoglycemia and hypertriglyceridemia. The mean maximum plasma concentration (C max ) of globalagliatin increased from 7.76 to 138.13 ng/mL (stage I), and 29.36 to 471.50 ng/mL (stage II), which occurred at 3-5 h post-dose. A steady state was achieved after 7 days of once-daily dosing in stage I and stage II, respectively. Mean area under the plasma-concentration curve for steady-state 24-h interval (AUC 0-24 ) increased from 106.13 to 2461.95 ng·h/mL (stage I) and 369.71 to 9218.38 ng·h/mL (stage II). Fasting plasma glucose (FPG) decreased continuously during the titration period. Compared with the placebo, high-dose globalagliatin significantly increased the reductions in FPG, the area under the curve of 24-h glucose levels, and glycated albumin, with least-squares mean changes (relative to baseline) of - 4.08 mmol/L (95% CI - 5.05 to - 3.12) (P < 0.01), - 103.93 mmol/L (95% CI - 135.80 to - 72.06) (P < 0.01), and - 4.71% (95% CI - 6.91 to - 2.51) (P < 0.01)), respectively. High-dose globalagliatin significantly increased the Matsuda index, indicating improved insulin resistance.
CONCLUSIONS
Globalagliatin was well tolerated and showed favorable pharmacokinetic profiles in Chinese patients with type 2 diabetes. High-dose globalagliatin reduced plasma glucose, and improved insulin resistance.
TRIAL REGISTRATION
Clinicaltrials.gov indentifier, NCT03414892.",2020,The mean maximum plasma concentration (C max ) of globalagliatin increased from 7.76 to 138.13 ,"['Chinese Patients with Type 2 Diabetes Mellitus', '24 patients were randomized (3:1 ratio) to receive', 'Chinese patients with type 2 diabetes']","['globalagliatin or placebo', 'placebo']","['hypoglycemia and hypertriglyceridemia', 'plasma glucose, and improved insulin resistance', 'Mean area under the plasma-concentration curve', 'mean maximum plasma concentration (C max ) of globalagliatin', 'Fasting plasma glucose (FPG', 'Safety, Pharmacokinetics, and Pharmacodynamics of Globalagliatin', 'reductions in FPG, the area under the curve of 24-h glucose levels, and glycated albumin', 'insulin resistance', 'safety, pharmacokinetics, and pharmacodynamics of globalagliatin', 'Matsuda index']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",24.0,0.433775,The mean maximum plasma concentration (C max ) of globalagliatin increased from 7.76 to 138.13 ,"[{'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Fu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Sufeng', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongwen', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Trial Unit, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongwen', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Suzhou Yabao Pharmaceutical R&D Co., Ltd., Suzhou, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Suzhou Yabao Pharmaceutical R&D Co., Ltd., Suzhou, Jiangsu, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China. zhengxuqin@njmu.edu.cn.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China. yangt@njmu.edu.cn.'}]",Clinical drug investigation,['10.1007/s40261-020-00971-x']
1341,33125782,Dietary L-carnitine affects the expression of genes involved in apoptosis and fatty acid metabolism in rooster testes.,"Thirty-six 12-week-old breeder roosters (Ross 308) were randomly allocated into three groups to receive L-carnitine (LC): LC-0, LC-250 or LC-500 mg/kg of diet to evaluate the effects of dietary LC on the expression of apoptotic-related genes and desaturases and elongase mRNA transcript levels, in the cockerel testicles. Alteration of Bak (Bcl2 antagonist/killer), Bcl2, Cas3, Cas8, Cas9, Elovl2, Elovl4, Elovl5, Fads1, Fads2 and Scd expression at 24 and 34 weeks of age was compared by real-time quantitative PCR. The expression of Bcl2 and Elovl5 was significantly up-regulated (p < .05), while Cas8 expression (p < .05) and Bak/Bcl2 ratio were reduced (p < .02) in the cockerel testicles at 24 weeks of age. Although Bak mRNA abundance decreased by dietary LC, Bak/Bcl2 ratio was not affected by the treatments at 34 weeks of age. The expression of Cas3 was down-regulated, while Fads2 was up-regulated in the cockerel testicles by dietary LC at 34 weeks of age (p < .05). The results demonstrate the beneficial effects of LC supplementation in suppression of the Bak/Bcl2 ratio by altering Bak and Bcl2 mRNA abundance and, ultimately, prevention of apoptosis. Furthermore, LC increased the expression of Elovl5 and Fads2 genes which are involved in the metabolism of long chain fatty acids.",2020,"The expression of Bcl2 and Elovl5 was significantly up-regulated (p < .05), while Cas8 expression (p < .05) and Bak/Bcl2 ratio were reduced (p < .02) in the cockerel testicles at 24 weeks of age.",['Thirty-six 12-week-old breeder roosters (Ross 308'],"['L-carnitine (LC): LC-0, LC-250 or LC-500\xa0mg/kg of diet']","[' Fads1, Fads2 and Scd expression', 'Cas8 expression', 'expression of Bcl2 and Elovl5', 'Bak/Bcl2 ratio', 'Bcl2 antagonist/killer', 'Alteration of Bak', 'expression of Cas3', 'suppression of the Bak/Bcl2 ratio by altering Bak and Bcl2 mRNA abundance and, ultimately, prevention of apoptosis', 'dietary LC, Bak/Bcl2 ratio', ' Bcl2, Cas3, Cas8, Cas9, Elovl2, Elovl4, Elovl5']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376515', 'cui_str': 'bcl-2 Genes'}, {'cui': 'C0574198', 'cui_str': 'Bashkir language'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}]",308.0,0.0183504,"The expression of Bcl2 and Elovl5 was significantly up-regulated (p < .05), while Cas8 expression (p < .05) and Bak/Bcl2 ratio were reduced (p < .02) in the cockerel testicles at 24 weeks of age.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Animal and Poultry Science, College of Aburaihan, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Seyed Davood', 'Initials': 'SD', 'LastName': 'Sharifi', 'Affiliation': 'Department of Animal and Poultry Science, College of Aburaihan, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Sharafi', 'Affiliation': 'Department of Poultry Sciences, Faculty of Agriculture, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Mohammadi-Sangcheshmeh', 'Affiliation': 'Department of Animal and Poultry Science, College of Aburaihan, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Abedheydari', 'Affiliation': 'Department of Embryology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}, {'ForeName': 'AliReza', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Embryology, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.'}]",Andrologia,['10.1111/and.13876']
1342,33127365,Discontinuing Nasal Continuous Positive Airway Pressure in Infants ≤32 Weeks of Gestational Age: A Randomized Control Trial.,"OBJECTIVES
To compare immediate cessation of nasal continuous positive airway pressure (NCPAP) vs a stepwise decrease in pressure on the duration of NCPAP therapy in infants born prematurely.
STUDY DESIGN
A single center study in infants 23 0 -32 6 weeks of gestational age. NCPAP was stopped either at 5 cm H 2 O (control) or 3 cm H 2 O after a stepwise pressure wean (wean) using defined stability and failure criteria. Primary outcome is total NCPAP days.
RESULTS
We enrolled 226 infants; 116 were randomly assigned to control and 110 to the wean group. There was no difference in the total NCPAP days between groups (median [25th, 75th percentiles] 16 [5, 36] vs 14 [7, 33] respectively). There were no differences between groups in secondary outcomes, including duration of hospital stay, critical care days, and oxygen supplementation. A higher proportion of control infants failed the initial attempt to discontinue NCPAP (43% vs 27%, respectively; P < .01) and required ≥2 attempts (20% vs 5%, respectively; P < .01). In addition, infants 23-27 weeks of gestational age in the wean group were 2.4-times more likely to successfully stop NCPAP at the first attempt (P = .02) vs controls.
CONCLUSIONS
Discontinuation of NCPAP after a gradual pressure wean to 3 cm H 2 O did not decrease the duration of NCPAP therapy compared with stopping from 5 cm H 2 O in infants ≤32 weeks of gestational age. However, weaning decreased failed initial attempts to stop NCPAP, particularly among infants <28 weeks of gestational age.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT02064712.",2020,"There was no difference in the total NCPAP days between groups (median (25 th ,75 th centiles) 16 (5,36) vs 14 (7,33) respectively).","['We enrolled 226 infants; 116', 'infants 23 0 -32 6 weeks gestational age (GA', 'Weeks Gestational Age', 'infants born prematurely', 'Infants ≤32']","['NCPAP', 'nasal continuous positive airway pressure (NCPAP', 'Discontinuing Nasal Continuous Positive Airway Pressure']","['duration of hospital stay, critical care days and oxygen supplementation', 'duration of NCPAP therapy', 'total NCPAP days']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",226.0,0.0528342,"There was no difference in the total NCPAP days between groups (median (25 th ,75 th centiles) 16 (5,36) vs 14 (7,33) respectively).","[{'ForeName': 'Venkatakrishna', 'Initials': 'V', 'LastName': 'Kakkilaya', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: venkat.kakkilaya@utsouthwestern.edu.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Sheron', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Ridpath', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'L Steven', 'Initials': 'LS', 'LastName': 'Brown', 'Affiliation': 'Parkland Health and Hospital System, Dallas, TX.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Rosenfeld', 'Affiliation': 'Division of Neonatal-Perinatal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.10.045']
1343,33145979,Low socioeconomic level and enterobius vermicularis: A interventional study to children and their mothers in home.,"To determine the effects of care and monitoring provided at home to children in whom Enterobius vermicularis is detected and their mothers on the presence of observing the parasite and the knowledge and practices of the children and their mothers on the issue. This study used a pre-test-post-test quasi-experimental design. In the study, 20 students and their mothers were determined as the experimental group, while 18 students and their mothers were determined as the control group. Home visits were made to the families of the children in the experimental group for 6 months. At these home visits, health education on the parasite was provided to the mothers and the children. There were highly significant differences between the experiment and control groups in terms of E. vermicularis presence, knowledge and hygiene practice scores (p < .001).",2020,"There were highly significant differences between the experiment and control groups in terms of E. vermicularis presence, knowledge and hygiene practice scores (p < .001).","['Low socioeconomic level and enterobius vermicularis', 'children and their mothers in home', '20 students and their mothers were determined as the experimental group, while 18 students and their mothers were determined as the control group']",[],"['E.\xa0vermicularis presence, knowledge and hygiene practice scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600211', 'cui_str': 'Enterobius vermicularis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0146377,"There were highly significant differences between the experiment and control groups in terms of E. vermicularis presence, knowledge and hygiene practice scores (p < .001).","[{'ForeName': 'Kamuran', 'Initials': 'K', 'LastName': 'Özdil', 'Affiliation': 'Department of Aged Care Program, Health Services Vocational School, Nevşehir Hacı Bektaş Veli University, Nevşehir, Turkey.'}, {'ForeName': 'Nimet', 'Initials': 'N', 'LastName': 'Karataş', 'Affiliation': 'Department of Nursing, Semra and Vefa Küçük Faculty of Health Sciences, Nevşehir Hacı Bektaş Veli University, Nevşehir, Turkey.'}, {'ForeName': 'Handan', 'Initials': 'H', 'LastName': 'Zincir', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Erciyes University, Kayseri, Turkey.'}]",Zoonoses and public health,['10.1111/zph.12774']
1344,33148771,Group Sessions or Home Visits for Early Childhood Development in India: A Cluster RCT.,"OBJECTIVES
Poor early childhood development in low- and middle-income countries is a major public health problem. Efficacy trials have shown the potential of early childhood development interventions but scaling up is costly and challenging. Guidance on effective interventions' delivery is needed. In an open-label cluster-randomized control trial, we compared the effectiveness of weekly home visits and weekly mother-child group sessions. Both included nutritional education, whose effectiveness was tested separately.
METHODS
In Odisha, India, 192 villages were randomly assigned to control, nutritional education, nutritional education and home visiting, or nutritional education and group sessions. Mothers with children aged 7 to 16 months were enrolled ( n = 1449). Trained local women ran the two-year interventions, which comprised demonstrations and interactions and targeted improved play and nutrition. Primary outcomes, measured at baseline, midline (12 months), and endline (24 months), were child cognition, language, motor development, growth and morbidity.
RESULTS
Home visiting and group sessions had similar positive average (intention-to-treat) impacts on cognition (home visiting: 0.324 SD, 95% confidence interval [CI]: 0.152 to 0.496, P = .001; group sessions: 0.281 SD, 95% CI: 0.100 to 0.463, P = .007) and language (home visiting: 0.239 SD, 95% CI: 0.072 to 0.407, P = .009; group sessions: 0.302 SD, 95% CI: 0.136 to 0.468, P = .001). Most benefits occurred in the first year. Nutrition-education had no benefit. There were no consistent effects on any other primary outcomes.
CONCLUSIONS
Group sessions cost $38 per child per year and were as effective on average as home visiting, which cost $135, implying an increase by a factor of 3.5 in the returns to investment with group sessions, offering a more scalable model. Impacts materialize in the first year, having important design implications.",2020,"There were no consistent effects on any other primary outcomes.
","['In Odisha, India, 192 villages', 'India', 'Mothers with children aged 7 to 16 months were enrolled ( n = 1449']","['control, nutritional education, nutritional education and home visiting, or nutritional education and group sessions', 'weekly home visits and weekly mother-child group sessions']","['child cognition, language, motor development, growth and morbidity', 'similar positive average (intention-to-treat) impacts on cognition']","[{'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",192.0,0.0780143,"There were no consistent effects on any other primary outcomes.
","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'Institute for Global Health, University College London, London, England; sallymcgregor@yahoo.com.'}, {'ForeName': 'Akanksha', 'Initials': 'A', 'LastName': 'Adya', 'Affiliation': 'Department of Anthropology, Psychology and Sociology, University of West Georgia, Carrollton, Georgia.'}, {'ForeName': 'Orazio', 'Initials': 'O', 'LastName': 'Attanasio', 'Affiliation': 'Department of Economics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Augsburg', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Jere', 'Initials': 'J', 'LastName': 'Behrman', 'Affiliation': 'Department of Economics and Sociology, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Bet', 'Initials': 'B', 'LastName': 'Caeyers', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Monimalika', 'Initials': 'M', 'LastName': 'Day', 'Affiliation': 'Centre for Early Childhood Education and Development at Ambedkar University, Delhi, India.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Jervis', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Kochar', 'Affiliation': 'Centre for Early Childhood Education and Development at Ambedkar University, Delhi, India.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Makkar', 'Affiliation': 'Pratham Education Foundation, India; and.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Meghir', 'Affiliation': 'Department of Economics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Phimister', 'Affiliation': 'Institute for Fiscal Studies, London, United Kingdom.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rubio-Codina', 'Affiliation': 'Inter-American Development Bank, Washington, DC.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Vats', 'Affiliation': 'Pratham Education Foundation, India; and.'}]",Pediatrics,['10.1542/peds.2020-002725']
1345,33118602,"Ingestion of a THC-Rich Cannabis Oil in People with Fibromyalgia: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.","OBJECTIVE
To determine the benefit of a tetrahydrocannabinol (THC)-rich cannabis oil on symptoms and quality of life of fibromyalgia patients.
METHODS
A double-blind, randomized, placebo-controlled clinical trial was conducted for eight weeks to determine the benefit of a THC-rich cannabis oil (24.44 mg/mL of THC and 0.51 mg/mL of cannabidiol [CBD]) on symptoms and quality of life of 17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil. The initial dose was one drop (∼1.22 mg of THC and 0.02 mg of CBD) a day with subsequent increases according to symptoms. The Fibromyalgia Impact Questionnaire (FIQ) was applied at pre- and postintervention moments and in five visits over eight weeks.
RESULTS
There were no significant differences on baseline FIQ score between groups. However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score. (P < 0.001). Analyzing isolated items on the FIQ, the cannabis group presented significant improvement on the ""feel good,"" ""pain,"" ""do work,"" and ""fatigue"" scores. The placebo group presented significant improvement on the ""depression"" score after intervention. There were no intolerable adverse effects.
CONCLUSIONS
Phytocannabinoids can be a low-cost and well-tolerated therapy to reduce symptoms and increase the quality of life of patients with fibromyalgia. Future studies are still needed to assess long-term benefits, and studies with different varieties of cannabinoids associated with a washout period must be done to enhance our knowledge of cannabis action in this health condition.",2020,"However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score.","['People with Fibromyalgia', 'fibromyalgia patients', '17 women with fibromyalgia, residents of a neighborhood with a low socioeconomic profile and a high incidence of violence in the city of Florianopolis, Brazil', 'patients with fibromyalgia']","['tetrahydrocannabinol (THC)-rich cannabis oil', 'cannabidiol [CBD', 'placebo', 'THC-rich cannabis oil (24.44\u2009mg/mL of THC', 'Placebo', 'THC-Rich Cannabis Oil']","['feel good,"" ""pain,"" ""do work,"" and ""fatigue"" scores', 'Fibromyalgia Impact Questionnaire (FIQ', 'baseline FIQ score', 'FIQ score', 'depression"" score', 'intolerable adverse effects', 'symptoms and quality of life', 'quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0556617', 'cui_str': 'Cannabis oil'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439294', 'cui_str': 'g/L'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",17.0,0.529243,"However, after the intervention, the cannabis group presented a significant decrease in FIQ score in comparison with the placebo group (P = 0.005) and in comparison with cannabis group baseline score.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Chaves', 'Affiliation': 'Public Health School, Municipal Health Secretary, Florianopolis, Brazil.'}, {'ForeName': 'Paulo Cesar T', 'Initials': 'PCT', 'LastName': 'Bittencourt', 'Affiliation': 'Department of Internal Medicine, Federal University of Santa Catarina, Florianopolis, Brazil.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Pelegrini', 'Affiliation': 'Department of Physical Education, Santa Catarina State University, Florianopolis, Brazil.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa303']
1346,33118603,Establishing Central Sensitization-Related Symptom Severity Subgroups: A Multicountry Study Using the Central Sensitization Inventory.,"OBJECTIVES
The goal of this study was to identify central sensitization-related symptom severity subgroups in a large multicountry sample composed of patients with chronic pain and pain-free individuals using the Central Sensitization Inventory (CSI).
METHODS
A large, pooled international (N = 8 countries) sample of chronic pain patients plus healthy subjects (total N = 2,620) was randomly divided into two subsamples for cross-validation purposes. First, a hierarchical cluster analysis (HCA) was performed using CSI item-level data as clustering variables (test sample; N = 1,312). Second, a latent profile analysis (LPA) was conducted to confirm the optimal number of CSI clusters (validation sample; N = 1,308). Finally, to promote implementation in real-world clinical practice, we built a free online Central Sensitization Inventory Symptom Severity Calculator.
RESULTS
In both HCA (N = 1,219 valid cases) and LPA (N = 1,245 valid cases) analyses, a three-cluster and three-profile solution, respectively, emerged as the most statistically optimal and clinically meaningful. Clusters were labeled as follows: (i) Low Level of CS-Related Symptom Severity, (ii) Medium Level of CS-Related Symptom Severity, and (iii) High Level of CS-Related Symptom Severity.
CONCLUSIONS
Our results indicated that a three-cluster solution clearly captured the heterogeneity of the CSI data. The calculator might provide an efficient way of classifying subjects into the cluster groups. Future studies should analyze the extent to which the CSI cluster classification correlates with other patient-reported and objective signs and symptoms of CS in patients with chronic pain, their associations with clinical outcomes, health-related costs, biomarkers, (etc.), and responsiveness to treatment.",2020,"In both HCA (N = 1,219 valid cases) and LPA (N = 1,245 valid cases) analyses, a three-cluster and three-profile solution, respectively, emerged as the most statistically optimal and clinically meaningful.","['chronic pain patients plus healthy subjects (total N\u2009=\u20092,620', 'Establishing Central Sensitization-Related Symptom Severity Subgroups', 'patients with chronic pain and pain-free individuals using the Central Sensitization Inventory (CSI']",['HCA'],"['i) Low Level of CS-Related Symptom Severity, (ii) Medium Level of CS-Related Symptom Severity, and (iii) High Level of CS-Related Symptom Severity']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0309131,"In both HCA (N = 1,219 valid cases) and LPA (N = 1,245 valid cases) analyses, a three-cluster and three-profile solution, respectively, emerged as the most statistically optimal and clinically meaningful.","[{'ForeName': 'Antonio I', 'Initials': 'AI', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Department of Physiotherapy of the Faculty of Health Science at the, University of Malaga, (IBIMA), Malaga, Spain.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Neblett', 'Affiliation': 'PRIDE Research Foundation, Dallas, Texas, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Nijs', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Pain in Motion International Research Group, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Chiarotto', 'Affiliation': 'Department of Health Sciences, Amsterdam Movement Sciences Research Institute, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Kregel', 'Affiliation': 'Department of Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'C Paul', 'Initials': 'CP', 'LastName': 'van Wilgen', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & Physiotherapy, Pain in Motion International Research Group, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Pitance', 'Affiliation': 'Neuro Musculoskeletal Lab, Institute of Clinical Research (IREC), Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Knezevic', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gatchel', 'Affiliation': 'Pain in Motion International Research Group, Vrije Universiteit, Brussels, Belgium.'}, {'ForeName': 'Tom G', 'Initials': 'TG', 'LastName': 'Mayer', 'Affiliation': 'Department of Orthopedic Surgery, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Viti', 'Affiliation': 'FACEit, Italian Association of Integrated Therapy for Cervico-Cranio-Facial Pain and Dysfunction, Barlassina, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Roldan-Jiménez', 'Affiliation': 'Department of Physiotherapy of the Faculty of Health Science at the, University of Malaga, (IBIMA), Malaga, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Testa', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genova, Campus of Savona, Savona, Italy.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Jeremic-Knezevic', 'Affiliation': 'Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Nishigami', 'Affiliation': 'Department of Physical Therapy, Faculty of Health and Welfare, Prefectural University of Hiroshima, Hiroshima, Japan.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Feliu-Soler', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Pérez-Aranda', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}, {'ForeName': 'Juan V', 'Initials': 'JV', 'LastName': 'Luciano', 'Affiliation': 'Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa210']
1347,33113452,Using Machine Learning to Predict Suicide Attempts in Military Personnel.,"Identifying predictors of suicide attempts is critical in intervention and prevention efforts, yet finding predictors has proven difficult due to the low base rate and underpowered statistical approaches. The objective of the current study was to use machine learning to examine predictors of suicidal behaviors among high-risk suicidal Soldiers who received outpatient mental health services in a randomized controlled trial of Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) compared to treatment as usual (TAU). Self-report measures of clinical and demographic variables, administered prior to the start of outpatient treatment to 152 participants with recent suicidal thoughts and/or behaviors were analyzed using machine learning software to identify the best combination of variables for predicting suicide attempts during or after treatment. Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period. This combination has higher sensitivity than many models that have previously been used to predict suicidal behavior. Overall, this study provides a combination of variables that can be assessed clinical to help identify high-risk suicidal individuals.",2020,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","['high-risk suicidal Soldiers who received outpatient mental health services', '152 participants with recent suicidal thoughts and/or behaviors', 'Military Personnel']","['Machine Learning', 'machine learning', 'Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT']",['suicidal behaviors'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}]",152.0,0.0395007,"Worst-point suicidal ideation, history of multiple suicide attempts, treatment group (i.e., BCBT or TAU), suicidogenic cognitions, and male sex were found, in combination, correctly classified 30.8% of patients who attempted suicide during the two-year follow-up period.","[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Rozek', 'Affiliation': 'UCF RESTORES and Department of Psychology, University of Central Florida. Electronic address: david.rozek@ucf.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Andres', 'Affiliation': 'Boston College, Boston, MA.'}, {'ForeName': 'Noelle B', 'Initials': 'NB', 'LastName': 'Smith', 'Affiliation': 'VA Northeast Program Evaluation Center, West Haven, CT, USA; Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Feea R', 'Initials': 'FR', 'LastName': 'Leifker', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Arne', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Jennings', 'Affiliation': 'Varen Technologies.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Dartnell', 'Affiliation': 'MondoBrain.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'The Ohio State University Wexner Medical Center.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'University of Memphis, Memphis, TN, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113515']
1348,33124591,"A Randomized Controlled Trial to Compare the Efficacy, Safety and Tolerability of Asenapine versus Olanzapine in Management of Schizophrenia.","Objective
: Schizophrenia is a serious disease characterized by impairment in the perception or expression of reality, leading to occupational and social dysfunction. The use of antipsychotic medication is now universal in the first-line treatment of schizophrenia. This study was undertaken to compare the efficacy of asenapine with a standard atypical antipsychotic, olanzapine in treating this disease.
Methods
It was designed as a single blind, randomized, controlled, parallel group, single centre Phase IV trial of a newer atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine. Total 80 subjects were enrolled as per eligibility criteria.Each recruited subject received daily treatment with the trial medication (Olanzapine 10 mg or Asenapine 10 mg daily) for duration of 12 weeks. BPRS, CGI-S, CGI-I, Laboratory parameters and compliance was assessed and analyzed. Continuous variables were compared by t test and non-parametric data was analyzed by Mann-Whitney U test and Wilcoxon signed rank test. Likely categorical variables were analyzed by chi-square test or Fisher's exact test, as appropriate.
Results
The duration of schizophrenia at presentation was comparable in both the treatment groups. There was significant reduction of BPRS score between any two visits of each treatment groups. The decline in CGI-S and CGI-I scores was statistically significant ( p < 0.001) when compared between visits of any of the both treatment arms. Adherence to treatment was excellent for all patients.
Conclusion
Newer atypical antipsychotic asenapine is more effective than standard olanzapine in reducing the symptoms of schizophrenia in this study and further larger studies are to be done.",2020,The decline in CGI-S and CGI-I scores was statistically significant ( p < 0.001) when compared between visits of any of the both treatment arms.,['Total 80 subjects were enrolled as per eligibility criteria'],"['olanzapine', 'trial medication (Olanzapine 10 mg or Asenapine', 'Asenapine versus Olanzapine', 'atypical antipsychotic, asenapine versus existing standard atypical antipsychotic, olanzapine', 'asenapine', 'antipsychotic medication']","['BPRS score', 'Efficacy, Safety and Tolerability', 'decline in CGI-S and CGI-I scores', 'BPRS, CGI-S, CGI', 'duration of schizophrenia at presentation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0988260', 'cui_str': 'olanzapine 10 MG'}, {'cui': 'C2000088', 'cui_str': 'Asenapine'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]",80.0,0.0257721,The decline in CGI-S and CGI-I scores was statistically significant ( p < 0.001) when compared between visits of any of the both treatment arms.,"[{'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Maitra', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': 'Department of Pharmacology, RG Kar Medical College, India.'}, {'ForeName': 'Sabyasachi', 'Initials': 'S', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Neonatology, AMRI Hospital, Kolkata, India.'}, {'ForeName': 'Asim Kumar', 'Initials': 'AK', 'LastName': 'Mallick', 'Affiliation': 'Department of Psychiatry, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Supreeti', 'Initials': 'S', 'LastName': 'Biswas', 'Affiliation': 'Department of Pharmacology, Burdwan Medical College, Burdwan, India.'}, {'ForeName': 'Om Prakash', 'Initials': 'OP', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, Burdwan Medical College, Burdwan, India.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.4.587']
1349,33124599,"Corrigendum: A Pharmacogenomic-based Antidepressant Treatment for Patients with Major Depressive Disorder: Results from an 8-week, Randomized, Single-blinded Clinical Trial.",,2020,,['Patients with Major Depressive Disorder'],['Pharmacogenomic-based Antidepressant Treatment'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C1138555', 'cui_str': 'Pharmacogenomic specialist'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0941954,,"[{'ForeName': 'Changsu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sheng-Min', 'Initials': 'SM', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Won-Myong', 'Initials': 'WM', 'LastName': 'Bahk', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Soo-Jung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Ashwin A', 'Initials': 'AA', 'LastName': 'Patkar', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Prakash S', 'Initials': 'PS', 'LastName': 'Masand', 'Affiliation': 'Global Medical Education, New York, NY, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mandelli', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Chi-Un', 'Initials': 'CU', 'LastName': 'Pae', 'Affiliation': 'Department of Psychiatry, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Serretti', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Psychiatric Section, University of Bologna, Bologna, Italy.'}]",Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology,['10.9758/cpn.2020.18.4.641']
1350,33122529,"Low-Molecular-Weight Heparin Combined With Insulin Versus Insulin Alone in the Treatment of Hypertriglyceridemic Pancreatitis (LIHTGP Trial): Study Protocol for a Multicenter, Prospective, Single-Blind, Randomized Controlled Trial.","OBJECTIVE
Currently, insulin and/or heparin/low-molecular-weight heparin (LMWH) serve as an early lipid-lowering treatment for hypertriglyceridemic pancreatitis (HTGP). However, whether the clinical prognosis of combining LMWH with insulin is superior to using insulin alone remains unknown. This trial will compare the clinical outcomes of LMWH with insulin and an insulin regimen for emergency lipid-lowering treatment in HTGP patients.
METHODS
In total, 476 eligible participants will be recruited from 18 hospitals throughout China. Participants in the LMWH group will receive LMWH combined with insulin, whereas insulin alone will be administered to those in the insulin group. The patients will be followed up at 3 and 6 months after discharge. Adverse reactions will be evaluated by the safety monitoring committee. Safety outcomes and adverse events will also be recorded.
RESULTS
The study is registered in the Chinese Clinical Trial Registry (No: ChiCTR1900023640). Recruitment will begin in August 2019 and will be completed in December 2021 (http://www.chictr.org.cn/index.aspx). No data are available now.
CONCLUSIONS
The trial will investigate the efficacy of using LMWH combined with insulin as an emergency lipid-lowering treatment in reducing new organ failure, mortality, hospital stays, and expenses compared using with insulin alone for patients with HTGP.",2020,"This trial will compare the clinical outcomes of LMWH with insulin and an insulin regimen for emergency lipid-lowering treatment in HTGP patients.
","['476 eligible participants will be recruited from 18 hospitals throughout China', 'HTGP patients', 'Hypertriglyceridemic Pancreatitis (LIHTGP Trial', 'patients with HTGP', 'hypertriglyceridemic pancreatitis (HTGP']","['insulin and/or heparin/low-molecular-weight heparin (LMWH', 'LMWH combined with insulin, whereas insulin alone', 'insulin alone', 'LMWH combined with insulin', 'Low-Molecular-Weight Heparin Combined With Insulin Versus Insulin Alone', 'LMWH with insulin and an insulin regimen', 'LMWH']","['new organ failure, mortality, hospital stays, and expenses', 'Safety outcomes and adverse events', 'Adverse reactions']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",476.0,0.192249,"This trial will compare the clinical outcomes of LMWH with insulin and an insulin regimen for emergency lipid-lowering treatment in HTGP patients.
","[{'ForeName': 'Bingjun', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'From the Department of Gastroenterology, The First Affiliated Hospital of Nanchang University, Nanchang, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Nianshuang', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'JiaRong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Youxiang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Nonghua', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': ''}]",Pancreas,['10.1097/MPA.0000000000001697']
1351,33125405,Factors influencing the bias between blood gas analysis versus central laboratory hemoglobin testing. A secondary analysis of a randomized controlled trial.,"BACKGROUND
Anemia is the most important complication during major surgery and transfusion of red blood cells is the mainstay to compensate for life threating blood loss. Therefore, accurate measurement of hemoglobin (Hb) concentration should be provided in real-time. Blood Gas Analysis (BGA) provides rapid point-of-care assessment using smaller sampling tubes compared to central laboratory (CL) services.
OBJECTIVE
This study aimed to investigate the accuracy of BGA hemoglobin testing as compared to CL services.
METHODS
Data of the ongoing LIBERAL-Trial (Liberal transfusion strategy to prevent mortality and anemia-associated ischemic events in elderly non-cardiac surgical patients, LIBERAL) was used to assess the bias for Hb level measured by BGA devices (ABL800 Flex analyzer®, GEM series® and RapidPoint 500®) and CL as the reference method. For that, we analyzed pairs of Hb level measured by CL and BGA within two hours. Furthermore, the impact of various confounding factors including age, gender, BMI, smoker status, transfusion of RBC, intraoperative hemodilution, and co-medication was elucidated. In order to ensure adequate statistical analysis, only data of participating centers providing more than 200 Hb pairs were used.
RESULTS
In total, three centers including 963 patients with 1,814 pairs of Hb measurements were analyzed. Mean bias was comparable between ABL800 Flex analyzer® and GEM series®: - 0.38 ± 0.15 g/dl whereas RapidPoint 500® showed a smaller bias (-0.09 g/dl) but greater median absolute deviation (± 0.45 g/dl). In order to avoid interference with different standard deviations caused by the different analytic devices, we focused on two centers using the same BGA technique (309 patients and 1,570 Hb pairs). A Bland-Altman analysis and LOWESS curve showed that bias decreased with smaller Hb values in absolute numbers but increased relatively. The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias. Intraoperative substitution of volume and other co-medications did not influence the bias significantly.
CONCLUSION
Many interventions like substitution of fluids, coagulating factors or RBC units rely on the accuracy of laboratory measurement devices. Although BGA Hb testing showed a consistently stable difference to CL, our data confirm that BGA devices are associated with different bias. Therefore, we suggest that hospitals assess their individual bias before implementing BGA as valid and stable supplement to CL. However, based on the finding that bias decreased with smaller Hb values, which in turn are used for transfusion decision, we expect no unnecessary or delayed RBC transfusion, and no major impact on the LIBERAL trial performance.",2020,"The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias.","['963 patients with 1,814 pairs of Hb measurements', '309 patients and 1,570 Hb pairs', 'elderly non-cardiac surgical patients, LIBERAL']",['BGA technique'],"['mortality and anemia-associated ischemic events', 'Mean bias', 'BMI', 'RBC transfusion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",963.0,0.0950543,"The smoker status showed the greatest reduction in bias (0.1 g/dl, p<0.001) whereas BMI (0.07 g/dl, p = 0.0178), RBC transfusion (0.06 g/dl, p<0.001), statins (0.04 g/dl, p<0.05) and beta blocker (0.03 g/dl, p = 0.02) showed a slight effect on bias.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Tanner', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lindau', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Velten', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Rheinische Friedrich-Wilhelms-University Bonn, Bonn Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schlesinger', 'Affiliation': 'Department of Anesthesiology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wittmann', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Rheinische Friedrich-Wilhelms-University Bonn, Bonn Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kranke', 'Affiliation': 'Department of Anesthesiology, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'Kira', 'Initials': 'K', 'LastName': 'Berg', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Piekarski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Füllenbach', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Choorapoikayil', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hasenclever', 'Affiliation': 'Institute for Medical Informatics, Statistics and Epidemiology (IMISE), Medical Faculty of the University Leipzig, Leipzig, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zacharowski', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Meybohm', 'Affiliation': 'Department of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt, Goethe University Frankfurt, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0240721']
1352,33125420,A comparison of endoscopic and microscopic inlay butterfly cartilage tympanoplasties and their educational utility.,"OBJECTIVES
Inlay butterfly cartilage tympanoplasty (IBCT) is a simple grafting technique. Endoscopy facilitates visualization by eliminating blind spots. We analyzed the outcomes of IBCT using both endoscopic and microscopic approaches, and assessed how trainees perceived the educational opportunities afforded.
MATERIALS AND METHODS
Sixty patients who underwent IBCT were allocated to Group I (n = 30; microscopic IBCT) and Group II (n = 30; endoscopic IBCT) by the dates of their visits. Anatomical success was defined as an intact, repaired tympanic membrane; functional success was defined as a significant decrease in the air-bone gap. Postoperative discomfort was analyzed using a visual analog scale (VAS). Thirteen trainees completed structured questionnaires exploring anatomical identification and the surgical steps.
RESULTS
The surgical success rates were 96.7% in Group I and 100% in Group II. We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort. Significant postoperative hearing improvements were evident in both groups. The mean operative time was shorter when the microscopic approach was chosen (17.7±4.53 vs. 26.13±9.94 min). The two approaches significantly differed in terms of the identification of external and middle ear anatomical features by the trainees, and their understanding of the surgical steps.
CONCLUSION
Both endoscopic and microscopic IBCT were associated with good success rates. The endoscopic approach facilitates visualization, and a better understanding of the middle ear anatomy and the required surgical steps and thus is of greater educational utility.",2020,We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort.,['Sixty patients who underwent'],"['Inlay butterfly cartilage tympanoplasty (IBCT', 'IBCT', 'endoscopic IBCT', 'microscopic IBCT']","['Significant postoperative hearing improvements', 'mean operative time', 'Postoperative discomfort', 'surgical success rates', 'visual analog scale (VAS', 'Anatomical success', 'identification of external and middle ear anatomical features']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0006496', 'cui_str': 'Butterfly'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",60.0,0.0269257,We found no between-group differences in the mean decrease in the air-bone gap or the extent of postoperative discomfort.,"[{'ForeName': 'Noor Dina', 'Initials': 'ND', 'LastName': 'Hashim', 'Affiliation': 'Department of Otorhinolaryngology, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Se A', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology, Soonchunhyang University Bucheon Hospital, Soonchunhyang University School of Medicine, Bucheon, Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Jang', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Seok', 'Initials': 'IS', 'LastName': 'Moon', 'Affiliation': 'Department of Otorhinolaryngology, Yonsei University College of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0241152']
1353,33128903,Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study.,"BACKGROUND
Fostemsavir, a prodrug of the first-in-class attachment inhibitor, temsavir, is indicated for heavily treatment-experienced individuals with multidrug-resistant HIV-1. We previously reported superior efficacy of fostemsavir versus placebo in the randomised cohort of the BRIGHTE study after 8-day functional monotherapy (primary endpoint); here we report planned interim analyses through week 96.
METHODS
BRIGHTE (NCT02362503) is an ongoing multicentre, two-cohort, phase 3 trial, done at 108 centres in 22 countries. We enrolled heavily treatment-experienced adults (≥18 years) failing antiretroviral therapy (HIV-1 RNA ≥400 copies per mL) into two cohorts: the randomised cohort, in which patients with one or two fully active antiretrovirals remaining received oral fostemsavir (600 mg twice a day) or placebo in combination with their failing regimen for 8 days, followed by fostemsavir plus optimised background therapy; or the non-randomised cohort, in which patients with no remaining antiretroviral options received oral fostemsavir (600 mg twice a day) plus optimised background therapy from day 1. Endpoints for the week 96 interim analyses included the proportions of participants with plasma HIV-1 RNA of less than 40 copies per mL, changes from baseline in CD4 cell counts, and the frequency of adverse events, adverse events leading to discontinuation, and deaths. The intention-to-treat exposed population and the safety population both included all participants who received at least one dose of study treatment. The response rates (proportion of participants with HIV-1 RNA <40 copies per mL) in the intention-to-treat exposed population were calculated via snapshot analysis at weeks 24, 48, and 96.
FINDINGS
Between Feb 23, 2015, and Aug 11, 2016, 371 participants were enrolled and treated, of which 272 participants were in the randomised cohort and 99 in the non-randomised cohort. 320 (86%) of 371 reported a history of AIDS. In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96. Response rates in the non-randomised cohort were 37% (37 of 99) at week 24 and week 96. Mean increases in CD4 counts from baseline at week 96 were 205 cells per μL (SD 191) in the randomised cohort and 119 cells per μL (202) in the non-randomised cohort. Mean CD4/CD8 ratio increased from 0·20 at baseline to 0·44 at week 96 in the randomised cohort. Few adverse events led to discontinuation (26 [7%] of 371). 12 (4%) of 272 people in the randomised cohort and 17 (17%) of 99 in the non-randomised cohort died; the median baseline CD4 count for participants who died was 11 cells per μL.
INTERPRETATION
In heavily treatment-experienced individuals with advanced HIV-1 disease and limited treatment options, fostemsavir-based antiretroviral regimens were generally well tolerated and showed a distinctive trend of increasing virological and immunological response rates through 96 weeks; these findings support fostemsavir as a treatment option for this vulnerable population.
FUNDING
ViiV Healthcare.",2020,"In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96.","['heavily treatment-experienced individuals', 'heavily treatment-experienced individuals with multidrug-resistant HIV-1', '108 centres in 22 countries', 'enrolled heavily treatment-experienced adults (≥18 years) failing antiretroviral therapy (HIV-1 RNA ≥400 copies per mL) into two cohorts: the randomised cohort, in which patients with one or two fully active antiretrovirals remaining received', 'Between Feb 23, 2015, and Aug 11, 2016, 371 participants were enrolled and treated, of which 272 participants were in the randomised cohort and 99 in the non-randomised cohort', '320 (86%) of 371 reported a history of AIDS']","['HIV-1 attachment inhibitor prodrug fostemsavir', 'placebo in combination with their failing regimen for 8 days, followed by fostemsavir plus optimised background therapy', 'oral fostemsavir', 'oral fostemsavir (600 mg twice a day) plus optimised background therapy', 'fostemsavir versus placebo']","['CD4 counts', 'response rates', 'Safety and efficacy', 'Response rates', 'Mean CD4/CD8 ratio', 'median baseline CD4 count', 'proportions of participants with plasma HIV-1 RNA', 'rates of virological suppression', 'CD4 cell counts', 'frequency of adverse events, adverse events leading to discontinuation, and deaths']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0033262', 'cui_str': 'Drug Precursors'}, {'cui': 'C4519220', 'cui_str': 'fostemsavir'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",272.0,0.540505,"In the randomised cohort, rates of virological suppression (HIV-1 RNA <40 copies per mL) increased from 53% (144 of 272) at week 24 to 60% (163 of 272) at week 96.","[{'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Lataillade', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA. Electronic address: max.x.lataillade@viivhealthcare.com.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Lalezari', 'Affiliation': 'Quest Clinical Research, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kozal', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases Section, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Aberg', 'Affiliation': 'Division of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Pialoux', 'Affiliation': 'Department of Infectious and Tropical Diseases, Hôpital Tenon, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundación Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Department of Infectious Diseases, Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': 'Department of Infectious Diseases, Hospital Universitario Ramón y Cajal, Alcalá University, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'STD and AIDS Clinical Research Laboratory, Infectious Diseases, Instituto de Pesquisa Clínica Evandro Chagas FIOCRUZ, Rio De Janeiro, Brazil.'}, {'ForeName': 'Ricardo S', 'Initials': 'RS', 'LastName': 'Diaz', 'Affiliation': 'Infectious Diseases Division, Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'Clinic of Infectious Diseases, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Princy N', 'Initials': 'PN', 'LastName': 'Kumar', 'Affiliation': 'Department of Medicine and Microbiology, Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Gulam H', 'Initials': 'GH', 'LastName': 'Latiff', 'Affiliation': 'Maxwell Centre, Durban, South Africa.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'De Jesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'GlaxoSmithKline, Upper Providence Township, PA, USA.'}, {'ForeName': 'Shiven', 'Initials': 'S', 'LastName': 'Chabria', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Pierce', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ackerman', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Llamoso', 'Affiliation': 'ViiV Healthcare, Branford, CT, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30240-X']
1354,33128906,A Bayesian averted infection framework for PrEP trials with low numbers of HIV infections: application to the results of the DISCOVER trial.,"Trials of candidate agents for HIV pre-exposure prophylaxis (PrEP) might randomly assign participants to be given a new PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine. This design presents unique challenges in interpretation. First, with two active arms, HIV incidence might be low. Second, the effectiveness of tenofovir disoproxil fumarate plus emtricitabine varies across populations; thus, similar HIV incidence between groups could be consistent with a wide range of effectiveness for the new PrEP. We propose a two-part approach to trial results. First, we use Bayesian methods to incorporate assumptions about the background incidence of HIV in the trial in the absence of PrEP, possibly augmented by external data. On the basis of the estimated background incidence, we estimate and compare the number of averted (or prevented) HIV infections in each of the two trial groups, calculating the averted infections ratio. We apply these methods to a completed trial of tenofovir alafenamide plus emtricitabine for PrEP. Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.",2020,Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.,[],"['PrEP agent or oral coformulated tenofovir disoproxil fumarate plus emtricitabine', 'HIV pre-exposure prophylaxis (PrEP', 'tenofovir disoproxil fumarate plus emtricitabine', 'tenofovir alafenamide plus emtricitabine']",['number of averted (or prevented) HIV infections'],[],"[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C1096319', 'cui_str': 'Prophylaxis against HIV infection'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]",,0.217817,Our framework shows that leveraging external information to estimate averted infections and the averted infections ratio enhances the efficiency and interpretation of active-controlled PrEP trials.,"[{'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA. Electronic address: david.glidden@ucsf.edu.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Stirrup', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Dunn', 'Affiliation': 'MRC Clinical Trials Unit, University College London, London, UK.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30192-2']
1355,33129376,"Venetoclax or placebo in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (BELLINI): a randomised, double-blind, multicentre, phase 3 trial.","BACKGROUND
Venetoclax is a highly selective, potent, oral BCL-2 inhibitor, which induces apoptosis in multiple myeloma cells. Venetoclax plus bortezomib and dexamethasone has shown encouraging clinical efficacy with acceptable safety and tolerability in a phase 1 trial. The aim of this study was to evaluate venetoclax plus bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
METHODS
In this randomised, double-blind, multicentre, phase 3 trial, patients aged 18 years or older with relapsed or refractory multiple myeloma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received one to three previous therapies were enrolled from 90 hospitals in 16 countries. Eligible patients were randomly assigned (2:1) centrally using an interactive response technology system and a block size of three to receive venetoclax (800 mg per day orally) or placebo with bortezomib (1·3 mg/m 2 subcutaneously or intravenously and dexamethasone (20 mg orally). Treatment was given in 21-day cycles for the first eight cycles and 35-day cycles from the ninth cycle until disease progression, unacceptable toxicity, or patient withdrawal. Randomisation was stratified by previous exposure to a proteasome inhibitor and the number of previous therapies. Sponsors, investigators, study site personnel, and patients were masked to the treatment allocation throughout the study. The primary endpoint was independent review committee-assessed progression-free survival in the intention-to-treat population. Safety analyses were done in patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, NCT02755597.
FINDINGS
Between July 19, 2016, and Oct 31, 2017, 291 patients were randomly assigned to receive venetoclax (n=194) or placebo (n=97). With a median follow-up of 18·7 months (IQR 16·6-21·0), median progression-free survival according to independent review committee was 22·4 months (95% CI 15·3-not estimable) with venetoclax versus 11·5 months (9·6-15·0) with placebo (hazard ratio [HR] 0·63 [95% CI 0·44-0·90]; p=0·010). The most common grade 3 or worse treatment-emergent adverse events were neutropenia (35 [18%] of 193 patients in the venetoclax group vs seven [7%] of 96 patients in the placebo group), pneumonia (30 [16%] vs nine [9%]), thrombocytopenia (28 [15%] vs 29 [30%]), anaemia (28 [15%] vs 14 [15%]), and diarrhoea (28 [15%] vs 11 [11%]). Serious treatment-emergent adverse events occurred in 93 (48%) patients in the venetoclax group and 48 (50%) patients in the placebo group, with eight (4%) treatment-emergent fatal infections reported in the venetoclax group and none reported in the placebo group. Three deaths in the venetoclax group (two from pneumonia and one from septic shock) were considered treatment-related; no deaths in the placebo group were treatment-related.
INTERPRETATION
The primary endpoint was met with a significant improvement in independent review committee-assessed progression-free survival with venetoclax versus placebo plus bortezomib and dexamethasone. However, increased mortality was seen in the venetoclax group, mostly because of an increased rate of infections, highlighting the importance of appropriate selection of patients for this treatment option.
FUNDING
AbbVie and Genentech.",2020,"Serious treatment-emergent adverse events occurred in 93 (48%) patients in the venetoclax group and 48 (50%) patients in the placebo group, with eight (4%) treatment-emergent fatal infections reported in the venetoclax group and none reported in the placebo group.","['Between July 19, 2016, and Oct 31, 2017, 291 patients', 'patients aged 18 years or older with relapsed or refractory multiple myeloma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received one to three previous therapies were enrolled from 90 hospitals in 16 countries', 'Eligible patients', 'patients with relapsed or refractory multiple myeloma']","['placebo plus bortezomib and dexamethasone', 'venetoclax plus bortezomib and dexamethasone', 'interactive response technology system and a block size of three to receive venetoclax', 'bortezomib and dexamethasone', 'Venetoclax or placebo', 'placebo', 'Venetoclax plus bortezomib and dexamethasone', 'placebo with bortezomib (1·3 mg/m 2 subcutaneously or intravenously and dexamethasone', 'venetoclax']","['pneumonia', 'rate of infections', 'diarrhoea', 'thrombocytopenia', 'mortality', 'Serious treatment-emergent adverse events', 'neutropenia', 'median progression-free survival', 'review committee-assessed progression-free survival', 'anaemia', 'treatment-emergent fatal infections']","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",291.0,0.759973,"Serious treatment-emergent adverse events occurred in 93 (48%) patients in the venetoclax group and 48 (50%) patients in the placebo group, with eight (4%) treatment-emergent fatal infections reported in the venetoclax group and none reported in the placebo group.","[{'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA. Electronic address: kumar.shaji@mayo.edu.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Harrison', 'Affiliation': 'Clinical Hematology, Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Seragnoli Institute of Hematology, Bologna University School of Medicine, Bologna, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'de la Rubia', 'Affiliation': 'Hematology Service, Dr Peset University Hospital, Valencia, Spain; School of Medicine and Dentistry, Catholic University of Valencia, Valencia, Spain.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'Department of Haematology, University College London Hospitals, London, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Gasparetto', 'Affiliation': 'School of Medicine, Duke University, Durham, NC, USA.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Clinica São Germano, São Paulo, Brazil.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Salwender', 'Affiliation': 'Department of Hematology-Oncology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona and Asklepios Klinik St Georg, Hamburg, Germany.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.'}, {'ForeName': 'Inho', 'Initials': 'I', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Punnoose', 'Affiliation': 'Oncology Biomarker Development, Product Development, Hemtology, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Wan-Jen', 'Initials': 'WJ', 'LastName': 'Hong', 'Affiliation': 'Oncology Biomarker Development, Product Development, Hemtology, Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Freise', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Anjla', 'Initials': 'A', 'LastName': 'Sood', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Jalaluddin', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Ross', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Ward', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Paulo C', 'Initials': 'PC', 'LastName': 'Maciag', 'Affiliation': 'Research and Development, AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital, Nantes, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30525-8']
1356,33129442,"Long-term follow-up from the ORATORIO trial of ocrelizumab for primary progressive multiple sclerosis: a post-hoc analysis from the ongoing open-label extension of the randomised, placebo-controlled, phase 3 trial.","BACKGROUND
The safety and efficacy of ocrelizumab in primary progressive multiple sclerosis were shown in the phase 3 ORATORIO trial. In this study, we assessed the effects of maintaining or switching to ocrelizumab therapy on measures of disease progression and safety in the open-label extension phase of ORATORIO.
METHODS
ORATORIO was an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial done at 182 study locations including academic centres, hospitals, and community speciality centres within 29 countries across the Americas, Australia, Europe, Israel, New Zealand, and Russia. Patients with primary progressive multiple sclerosis aged 18-55 years who had an Expanded Disability Status Scale (EDSS) score of 3·0-6·5 were eligible for enrolment. Those who had previous treatment with B-cell-targeted therapies or other immunosuppressive medications were excluded. Eligible participants were randomly assigned (2:1) to receive either intravenous infusion of 600 mg of ocrelizumab (two 300 mg infusions 14 days apart) or placebo every 24 weeks for at least 120 weeks until a prespecified number (n=253) of disability events occurred. After the double-blind phase, patients entered an extended controlled period of variable duration, during which they and investigators became aware of treatment allocation. Following this period, patients could enter an optional open-label extension, during which they continued ocrelizumab or switched from placebo to ocrelizumab. Time to onset of disability progression was confirmed at 24 weeks with four measures (ie, increase in EDSS score, ≥20% increase in time to complete the 9-Hole Peg Test [9HPT], ≥20% increase in time to perform the Timed 25-Foot Walk [T25FW], and composite progression defined as the first confirmed occurrence of any of these three individual measures), as was time to requiring a wheelchair (EDSS ≥7). Conventional MRI measures were also analysed. The intention-to-treat population was used for the safety and efficacy analyses; all analyses, and their timings, were done post hoc. ORATORIO is registered with ClinicalTrials.gov, NCT01194570, and is ongoing.
FINDINGS
From March 3, 2011, to Dec 27, 2012, 488 patients were randomly assigned to the ocrelizumab group and 244 to the placebo group. The extended controlled period started on July 24, 2015, and ended on April 27, 2016, when the last patient entered the open-label extension. Overall, 544 (74%) of 732 participants completed the double-blind period to week 144; 527 (97%) of 544 entered the open-label extension phase, of whom 451 (86%) are ongoing in the open-label extension. After at least 6·5 study years (48 weeks per study year) of follow-up, the proportion of patients with progression on disability measures was lower in those who initiated ocrelizumab early than in those initially receiving placebo for most of the measures of 24-week confirmed disability progression: EDSS, 51·7% vs 64·8% (difference 13·1% [95% CI 4·9-21·3]; p=0·0018); 9HPT, 30·6% vs 43·1% (12·5% [4·1-20·9]); p=0·0035); T25FW, 63·2% vs 70·7% (7·5% [-0·3 to 15·2]; p=0·058); composite progression, 73·2% vs 83·3% (10·1% [3·6-16·6]; p=0·0023); and confirmed time to requiring a wheelchair, 11·5% vs 18·9% (7·4% [0·8-13·9]; p=0·0274). At study end, the percentage change from baseline was lower in those who initiated ocrelizumab early than in those initially receiving placebo for T2 lesion volume (0·45% vs 13·00%, p<0·0001) and T1 hypointense lesion volume (36·68% vs 60·93%, p<0·0001). Over the entire period, in the ORATORIO all ocrelizumab exposure population, the rate of adverse events was 238·09 (95% CI 232·71-243·57) per 100 patient-years and serious adverse events was 12·63 (95% CI 11·41-13·94) per 100 patient-years; the most common serious adverse events were infections at 4·13 (95% CI 3·45-4·91) per 100 patient-years. No new safety signals emerged compared with the double-blind phase of ORATORIO.
INTERPRETATION
Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up. Although this study shows the benefit of earlier intervention with ocrelizumab in primary progressive disease, progression remains an important unmet need in multiple sclerosis. Further research should focus on how the potential benefits described in this study might be improved upon, particularly over longer time periods.
FUNDING
F Hoffmann-La Roche.",2020,"Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up.","['732 participants completed the double-blind period to week 144; 527 (97%) of 544 entered the open-label extension phase, of whom 451 (86%) are ongoing in the open-label extension', '182 study locations including academic centres, hospitals, and community speciality centres within 29 countries across the Americas, Australia, Europe, Israel, New Zealand, and Russia', 'From March 3, 2011, to Dec 27, 2012, 488 patients', 'primary progressive multiple sclerosis', 'Eligible participants', 'Patients with primary progressive multiple sclerosis aged 18-55 years who had an Expanded Disability Status Scale (EDSS) score of 3·0-6·5 were eligible for enrolment', 'Those who had previous treatment with B-cell-targeted therapies or other immunosuppressive medications were excluded']","['intravenous infusion of 600 mg of ocrelizumab', 'ocrelizumab', 'maintaining or switching to ocrelizumab therapy', 'ocrelizumab or switched from placebo to ocrelizumab', 'placebo']","['proportion of patients with progression on disability measures', 'EDSS score', 'time to requiring a wheelchair (EDSS ≥7', 'disease progression', 'disease progression and safety', 'T1 hypointense lesion volume', 'time to perform the Timed 25-Foot Walk', 'rate of adverse events', 'Time to onset of disability progression', 'Conventional MRI measures', 'time to complete the 9-Hole Peg Test [9HPT', 'serious adverse events']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",488.0,0.35322,"Compared with patients switching from placebo, earlier and continuous ocrelizumab treatment provided sustained benefits on measures of disease progression over the 6·5 study years of follow-up.","[{'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: jerry.s.wolinsky@uth.tmc.edu.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Arnold', 'Affiliation': 'Department of Neurology and Neurosurgery, Faculty of Medicine, McGill University, Montreal, QC, Canada; NeuroRx Research, Montreal, QC, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Department of Neurology, University of Bordeaux, Bordeaux, France.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Universitätsklinikum Düsseldorf, Center of Neurology and Neuropsychiatry, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""Neurology-Neuroimmunology Department and Neurorehabilitation Unit, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Manfrini', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Overell', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Koendgen', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Sauter', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Bennett', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Hubeaux', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': 'Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30342-2']
1357,33137352,The relationship between exercise intensity and neurophysiological responses to food stimuli in women: A randomized crossover event-related potential (ERP) study.,"We tested the effect of different intensities of acute exercise on hunger, and post-exercise energy intake, and neurophysiological measures of attention towards food- and non-food stimuli in women. In a within-subjects crossover design, forty-two women completed no exercise, moderate-intensity exercise, and vigorous-intensity exercise sessions separated by one week, in a counterbalanced fashion. At each session, participants completed a passive viewing task of food (high- and low-calorie) and non-food pictures while electroencephalogram (EEG) data were recorded. The early posterior negativity (EPN), P3, and late positive potential (LPP) components of the event-related potential (ERP) measured neurophysiological responses. Subjective ratings of hunger were measured before and immediately after each condition using a visual analog scale (VAS) and food intake was measured using an ad libitum snack buffet offered at the end of each condition. Results indicated that hunger levels increased as time passed for all sessions. EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food stimuli. LPP amplitude did not differ by high-calorie, low-calorie, or non-food images. Notably, there were no significant main effects or interactions of any ERP component amplitude as a function of exercise intensity. Food intake also did not differ by rest or moderate or vigorous exercise, although subjective arousal ratings to the images were higher after moderate and vigorous exercise compared to rest. Food images also had higher arousal and valence ratings than non-food images overall. Findings indicate that, in this sample, acute moderate and vigorous exercise compared to rest did not disproportionately affect neurophysiological measures of attention to food or non-food stimuli, caloric intake, or hunger.",2020,EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food items.,['women'],['passive viewing task of food (high- and low-calorie) and non-food pictures while electroencephalogram (EEG'],"['neurophysiological measures of attention to food or non-food stimuli, caloric intake, or hunger', 'higher arousal and valence ratings', 'early posterior negativity (EPN), P3, and late positive potential (LPP) components of the event-related potential (ERP) measured neurophysiological responses', 'LPP amplitude', 'subjective arousal ratings', 'visual analog scale (VAS) and food intake', 'Subjective ratings of hunger', 'EPN amplitude', 'hunger levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0014614', 'cui_str': 'Ethyl nitrophenyl benzene thiophosphonate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",42.0,0.0752239,EPN amplitude was larger to non-food compared to food images; P3 amplitude was larger to food than non-food items.,"[{'ForeName': 'Kaylie A', 'Initials': 'KA', 'LastName': 'Carbine', 'Affiliation': 'Department of Psychology, California State University Dominguez Hills, United States of America.'}, {'ForeName': 'Jillesa', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, United States of America.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Larson', 'Affiliation': 'Department of Psychology, Brigham Young University, United States of America; Neuroscience Center, Brigham Young University, United States of America.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'LeCheminant', 'Affiliation': 'Department of Nutrition, Dietetics, and Food Science, Brigham Young University, United States of America.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bailey', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, United States of America. Electronic address: bruce_bailey@byu.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.011']
1358,33141102,"Effect of Pain Education and Exercise on Pain and Function in Chronic Achilles Tendinopathy: Protocol for a Double-Blind, Placebo-Controlled Randomized Trial.","BACKGROUND
Achilles tendinopathy (AT) rehabilitation traditionally includes progressive tendon loading exercises. Recent evidence suggests a biopsychosocial approach that incorporates patient education on psychosocial factors and mechanisms of pain can reduce pain and disability in individuals with chronic pain. This is yet to be examined in individuals with AT.
OBJECTIVE
This study aims to compare the effects on movement-evoked pain and self-reported function of pain education as part of a biopsychosocial approach with pathoanatomical education for people with AT when combined with a progressive tendon loading exercise program.
METHODS
A single-site, randomized, double-blind, placebo-controlled clinical trial will be conducted in a university-based hospital in a laboratory setting and/or by telehealth. A total of 66 participants with chronic (>3 months) midportion or insertional AT will be randomized for the Tendinopathy Education of the Achilles (TEAch) study. All participants will complete progressive Achilles tendon loading exercises over 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. All participants will complete 6-7 one-to-one sessions with a physical therapist to progress exercises in a standardized manner over 8 weeks. During the last 4 weeks of the intervention, participants will be encouraged to maintain their home exercise program. Participants will be randomized to 1 of 2 types of education (pain education or pathoanatomic), in addition to exercise. Pain education will focus on the biological and psychological mechanisms of pain within a biopsychosocial framing of AT. Pathoanatomic education will focus on biological processes within a more traditional biomedical framework of AT. Evaluation sessions will be completed at baseline and 8-week follow-up, and self-reported outcome measures will be completed at the 12-week follow-up. Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated. Primary outcomes are movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system-Physical Function). Secondary outcomes assess central nervous system nociceptive processing, psychological factors, motor function, and feasibility.
RESULTS
Institutional review board approval was obtained on April 15, 2019, and study funding began in July 2019. As of March 2020, we randomized 23 out of 66 participants. In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants. We anticipate completing the primary data analysis by March 2022.
CONCLUSIONS
The TEAch study will evaluate the utility of pain education for those with AT and the effects of improved patient knowledge on pain, physical function, and clinical outcomes.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/19111.",2020,Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated.,"['individuals with chronic pain', 'people with AT when combined with a progressive tendon loading exercise program', 'In September 2020, we screened 267 individuals, consented 68 participants, and randomized 51 participants', 'individuals with AT', '66 participants', '66 participants with chronic (>3 months) midportion or insertional AT', 'Chronic Achilles Tendinopathy', 'a university-based hospital in a laboratory setting and/or by telehealth']","['education (pain education or pathoanatomic), in addition to exercise', 'physical therapist to progress exercises', 'placebo', 'Placebo', 'Pain Education and Exercise']","['central nervous system nociceptive processing, psychological factors, motor function, and feasibility', 'pain and disability', 'pain, physical function, and clinical outcomes', 'Pain and Function', 'movement-evoked pain during heel raises and self-reported function (patient-reported outcome measure information system-Physical Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3838864', 'cui_str': 'Insertional Achilles tendinopathy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]",51.0,0.25608,Both groups will complete progressive Achilles loading exercises in 4 phases throughout the 12 weeks and will be encouraged to continue with self-selected exercises as tolerated.,"[{'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Post', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Ebonie K', 'Initials': 'EK', 'LastName': 'Rio', 'Affiliation': 'School of Allied Health, La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'G Lorimer', 'Initials': 'GL', 'LastName': 'Moseley', 'Affiliation': 'IMPACT in Health, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Emine O', 'Initials': 'EO', 'LastName': 'Bayman', 'Affiliation': 'Departments of Biostatistics and Anesthesia, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Mederic M', 'Initials': 'MM', 'LastName': 'Hall', 'Affiliation': 'University of Iowa Sports Medicine, Department of Orthopaedics & Rehabilitation, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'de Cesar Netto', 'Affiliation': 'Department of Orthopaedics & Rehabiliation, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Wilken', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Danielson', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chimenti', 'Affiliation': 'Department of Physical Therapy & Rehabilitation Science, University of Iowa, Iowa City, IA, United States.'}]",JMIR research protocols,['10.2196/19111']
1359,33142129,"Comparing stigmatizing attitudes toward anorexia nervosa, binge-eating disorder, avoidant-restrictive food intake disorder, and subthreshold eating behaviors in college students.","OBJECTIVE
The relative stigmatization of various eating disorders (ED) remains understudied, and there is no research examining stigma toward avoidant-restrictive food intake disorder (ARFID) or adult picky eating. The present study examined the relative stigmatization of various EDs and the subthreshold eating behaviors that are risk factors for their development, and the relation of gender differences to stigma.
METHOD
A sample of 1147 college students was recruited and completed the study online. Participants were randomized and presented with a vignette representing a clinical ED [anorexia nervosa (AN), binge-eating disorder (BED), ARFID] or a subthreshold eating presentation (restrained eating, emotional eating, picky eating). Participants completed measures of stigma and perceived psychopathology. A 6 (target eating behavior) × 2 (target gender) × 2 (participant gender) MANOVA and subsequent ANOVAs were employed.
RESULTS
Measures of stigma revealed significant main effects for eating presentation and participant gender. There were also significant interactions between eating presentation and participant gender. Men reported more stigmatizing views toward BED and AN compared to women. Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma. Participants rated BED and AN as more pathological than all other targets, emotional eating and ARFID as more pathological than picky eating and restrained eating, and restrained eating as less pathological than all other targets.
CONCLUSIONS
Future research should explore how the severity of eating behavior influences perceptions and at what level behaviors such as restriction are recognized as disordered.",2020,"Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma.","['college students', 'Participants were randomized and presented with a vignette representing a clinical ED [anorexia nervosa (AN), binge-eating disorder (BED), ARFID] or a subthreshold eating presentation (restrained eating, emotional eating, picky eating', '1147 college students']",[],['stigma and perceived psychopathology'],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",1147.0,0.0365584,"Overall, restraint was stigmatized less than the other targets, and AN received the greatest amount of stigma.","[{'ForeName': 'Jordan M', 'Initials': 'JM', 'LastName': 'Ellis', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America; Wilford Hall Ambulatory Medical Center, Joint Base San Antonio - Lackland, United States of America. Electronic address: jordanellisphd@gmail.com.'}, {'ForeName': 'Jamal H', 'Initials': 'JH', 'LastName': 'Essayli', 'Affiliation': 'Department of Pediatrics and Psychiatry & Behavioral Health, Penn State College of Medicine, United States of America.'}, {'ForeName': 'Hana F', 'Initials': 'HF', 'LastName': 'Zickgraf', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rossi', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Reid', 'Initials': 'R', 'LastName': 'Hlavka', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Carels', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}, {'ForeName': 'Matt C', 'Initials': 'MC', 'LastName': 'Whited', 'Affiliation': 'Department of Psychology, East Carolina University, United States of America.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101443']
1360,33142167,"Comparison of intravenous ibuprofen and paracetamol efficiency in soft tissue injuries: A randomized, double-blind study.",,2020,,['soft tissue injuries'],['ibuprofen'],[],"[{'cui': 'C0037578', 'cui_str': 'Soft tissue injury'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]",[],,0.347795,,"[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Yalçınlı', 'Affiliation': 'Department of Emergency Medicine, Ege University, 35100 Izmir, Turkey. Electronic address: sercan.yalcinli@ege.edu.tr.'}, {'ForeName': 'Güçlü Selahattin', 'Initials': 'GS', 'LastName': 'Kıyan', 'Affiliation': 'Department of Emergency Medicine, Ege University, 35100 Izmir, Turkey.'}, {'ForeName': 'Özge', 'Initials': 'Ö', 'LastName': 'Can', 'Affiliation': 'Department of Emergency Medicine, Ege University, 35100 Izmir, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.06.063']
1361,33142168,Measuring the physiological impact of extreme heat on lifeguards during cardiopulmonary resuscitation. Randomized simulation study.,"OBJECTIVE
Lifeguard teams carry out their work in extremely hot conditions in many parts of the world. The aim of this study was to analyze the impact of high temperatures on physiological parameters during cardiopulmonary resuscitation (CPR).
METHOD
A randomized quasi-experimental cross-over design was used to test physiological lifesaving demands (50 min acclimatization +10 min CPR) in two different thermal environments: Thermo-neutral environment (25 °C) vs Hyperthermic environment (37 °C).
RESULTS
The data obtained from 21 lifeguards were included, this covers a total of 420 min of resuscitation. The CPR performance was constantly maintained during the 10 min. The Oxygen uptake (VO 2) ranged from 17 to 18 ml/min/kg for chest compressions (CC) and between 13 and 14 ml/min/kg for ventilations (V) at both 25 °C and 37 °C, with no significant difference between environments (p > 0.05). The percentage of maximum heart rate (%HR max) increased between 7% and 8% at 37 °C (p < 0.001), ranging between 75% and 82% of HR max. The loss of body fluids (LBF) was higher in the hyperthermic environment; LBF: (37 °C: 400 ± 187 g vs 25 °C: 148 ± 81 g, p < 0.001). Body temperature was 1 °C higher at the end of the test (p < 0.001). The perceived fatigue (RPE) increased by 37° an average of 2 points on a scale of 10 (p = 0.001).
CONCLUSIONS
Extreme heat is not a limiting factor in CPR performance with two lifeguards. Metabolic consumption is sustained, with an increase in CC, so V can serve as active rest. Nevertheless, resuscitation at 37 °C results in a higher HR, is more exhausting and causes significant loss of fluids due to sweating.",2020,"The perceived fatigue (RPE) increased by 37° an average of 2 points on a scale of 10 (p = 0.001).
",['187\xa0g vs 25'],"['neutral environment (25\xa0°C) vs Hyperthermic environment', 'hyperthermic environment; LBF']","['CPR performance', 'Body temperature', 'percentage of maximum heart rate (%HR max', 'Oxygen uptake', 'perceived fatigue (RPE', 'loss of body fluids (LBF']","[{'cui': 'C4517618', 'cui_str': '187'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]","[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",,0.0691278,"The perceived fatigue (RPE) increased by 37° an average of 2 points on a scale of 10 (p = 0.001).
","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Barcala-Furelos', 'Affiliation': ""Faculty of Education and Sport Sciences, REMOSS Research Group, Universidade de Vigo, Pontevedra, Spain; CLINURSID Research Group, Nursing Department, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Santiago de Compostela's Health Research Institute (IDIS), Santiago de Compostela, Spain. Electronic address: roberto.barcala@uvigo.es.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Fernández-Méndez', 'Affiliation': ""CLINURSID Research Group, Nursing Department, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Santiago de Compostela's Health Research Institute (IDIS), Santiago de Compostela, Spain; School of Nursing, REMOSS Research Group, Universidade de Vigo, Pontevedra, Spain. Electronic address: mariajosefernandezmendez@gmail.com.""}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Cano-Noguera', 'Affiliation': 'Faculty of Sport, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Martín', 'Initials': 'M', 'LastName': 'Otero-Agra', 'Affiliation': 'Faculty of Education and Sport Sciences, REMOSS Research Group, Universidade de Vigo, Pontevedra, Spain. Electronic address: martinoteroagra@gmail.com.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morán-Navarro', 'Affiliation': 'Faculty of Sport, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Martínez-Isasi', 'Affiliation': ""CLINURSID Research Group, Nursing Department, Universidade de Santiago de Compostela, Santiago de Compostela, Spain; Santiago de Compostela's Health Research Institute (IDIS), Santiago de Compostela, Spain. Electronic address: smtzisasi@gmail.com.""}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.06.042']
1362,33142248,"Visualization of aggregate perioperative data improves anesthesia case planning: A randomized, cross-over trial.","STUDY OBJECTIVE
A challenge in reducing unwanted care variation is effectively managing the wide variety of performed surgical procedures. While an organization may perform thousands of types of cases, privacy and logistical constraints prevent review of previous cases to learn about prior practices. To bridge this gap, we developed a system for extracting key data from anesthesia records. Our objective was to determine whether usage of the system would improve case planning performance for anesthesia residents.
DESIGN
Randomized, cross-over trial.
SETTING
Vanderbilt University Medical Center.
MEASUREMENTS
We developed a web-based, data visualization tool for reviewing de-identified anesthesia records. First year anesthesia residents were recruited and performed simulated case planning tasks (e.g., selecting an anesthetic type) across six case scenarios using a randomized, cross-over design after a baseline assessment. An algorithm scored case planning performance based on care components selected by residents occurring frequently among prior anesthetics, which was scored on a 0-4 point scale. Linear mixed effects regression quantified the tool effect on the average performance score, adjusting for potential confounders.
MAIN RESULTS
We analyzed 516 survey questionnaires from 19 residents. The mean performance score was 2.55 ± SD 0.32. Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001). Additionally, a 0.055 point improvement due to the ""learning effect"" was observed from each assessment to the next (95% CI 0.034 to 0.077; p < 0.001). Assessment score was also significantly associated with specific case scenarios (p < 0.001).
CONCLUSIONS
This study demonstrated the feasibility of developing of a clinical data visualization system that aggregated key anesthetic information and found that the usage of tools modestly improved residents' performance in simulated case planning.",2020,Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001).,"['Vanderbilt University Medical Center', '516 survey questionnaires from 19 residents', 'First year anesthesia residents']",[],"['mean performance score', 'learning effect', 'Assessment score']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0730956,Utilization of the tool was associated with an average score improvement of 0.120 points (95% CI 0.060 to 0.179; p < 0.001).,"[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Wanderer', 'Affiliation': 'Department of Anesthesiology, Department of Biomedical Informatics, Vanderbilt University Medical Center, United States. Electronic address: jon.wanderer@vumc.org.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Lasko', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Coco', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Leslie C', 'Initials': 'LC', 'LastName': 'Fowler', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'McEvoy', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Shotwell', 'Affiliation': 'Department of Biostatistics, Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Gelfand', 'Affiliation': 'Department of Anesthesiology, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Novak', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University Medical Center, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Owens', 'Affiliation': 'Owen Graduate School of Management, Vanderbilt University, United States.'}, {'ForeName': 'Daniel V', 'Initials': 'DV', 'LastName': 'Fabbri', 'Affiliation': 'Department of Biomedical Informatics, Department of Computer Science, Vanderbilt University Medical Center, United States.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110114']
1363,33142249,Dose dependent reduction in median effective concentration (EC 50 ) of ropivacaine with adjuvant dexmedetomidine in labor epidural analgesia: An up-down sequential allocation study.,"STUDY OBJECTIVE
Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia. However, the potency of dexmedetomidine has not been fully studied. The purpose of this study was to determine the median effective concentration (EC 50 ) of ropivacaine with adjuvant dexmedetomidine.
DESIGN
Prospective, double-blind, up-down sequential allocation study.
SETTING
Academic medical center specializing in the care of women and children.
PATIENTS
One hundred and fifty healthy, term parturients requesting labor epidural analgesia were randomly assigned to 1 of 5 different concentrations of dexmedetomidine: 0 μg/ml, 0.3 μg/ml, 0.4 μg/ml, 0.5 μg/ml, or 0.6 μg/ml.
INTERVENTIONS
The study solution for the first patient in each group included the randomly assigned concentration of dexmedetomidine in 0.1% ropivacaine. Subsequent patients in each randomization group received the assigned concentration of dexmedetomidine in a new concentration of ropivacaine as determined by the up-down allocation methodology. Effective analgesia was defined as pain on the visual analogue scale of<3 at30 min after administration of local anesthetic. The up-down sequential allocation method and probit regression were used to calculate the EC 50 of epidural ropivacaine.
MEASUREMENTS
The primary outcome was pain 30 min after administration of local anesthetic via epidural catheter. Exploratory outcomes included side effects, neonatal outcomes, and obstetric outcomes.
MAIN RESULTS
The EC 50 values for ropivacaine in dexmedetomidine 0.4 μg/ml, 0.5 μg/ml, and 0.6 μg/ml (0.044% [95% CI 0.036% to 0.045%], 0.035% [95% CI 0.031% to 0.041%], and 0.039% [95% CI 0.034% to 0.045%], respectively) were lower compared to ropivacaine in dexmedetomidine 0 μg/ml and 0.3 μg/ml (0.086% [95% CI 0.081% to 0.092%], and, 0.069% [95% CI 0.056% to 0.076%], respectively). Differences between EC 50 values for ropivacaine in dexmedetomidine 0.4 μg/ml, 0.5 μg/ml, and 0.6 μg/ml were not statistically significant. Results of our exploratory analyses did not reveal differences in side effects, neonatal outcomes, or obstetric outcomes.
CONCLUSIONS
In this study, the lowest concentration of dexmedetomidine in ropivacaine with the greatest clinical effect was 0.4 μg/ml, which is important because there may be no additional analgesic benefit of dexmedetomidine greater than 0.4 μg/ml.",2020,Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia.,"['Academic medical center specializing in the care of women and children', 'One hundred and fifty healthy, term parturients requesting labor epidural analgesia', 'labor epidural analgesia']","['dexmedetomidine: 0\xa0μg/ml, 0.3\xa0μg/ml', 'ropivacaine', 'dexmedetomidine']","['side effects, neonatal outcomes, or obstetric outcomes', 'median effective concentration', 'pain 30\xa0min after administration of local anesthetic via epidural catheter', 'side effects, neonatal outcomes, and obstetric outcomes']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}]",150.0,0.494868,Adjuvant dexmedetomidine can be used to reduce the required concentration of ropivacaine for labor epidural analgesia.,"[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Drzymalski', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Wangping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Lizhong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing Maternity and Child Care Hospital, Jiaxing City, China. Electronic address: 13706597501@163.com.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110115']
1364,33156550,Exposure-Response Analyses for Upadacitinib Efficacy in Subjects With Atopic Dermatitis-Analyses of Phase 2b Study to Support Selection of Phase 3 Doses.,"Upadacitinib is a selective Janus kinase 1 inhibitor that was recently approved for treatment of rheumatoid arthritis and is currently being evaluated for treatment of several other autoimmune diseases, including atopic dermatitis (AD). The relationships between upadacitinib plasma exposure and efficacy (assessed as Eczema Area Severity Index [EASI]-75, EASI-90, and Investigator Global Assessment [IGA] 0/1) in subjects with moderate to severe atopic dermatitis were characterized using the data from 167 subjects who were enrolled in a phase 2b dose-ranging study. Subjects were randomized to receive once daily doses of monotherapy treatment with upadacitinib extended-release 7.5, 15, or 30 mg or placebo for 16 weeks. Logistic regression models were developed and utilized to simulate efficacy for upadacitinib with an approximate phase 3 sample size. Based on exposure-response models, 15 mg once daily is predicted to achieve EASI-75, EASI-90, and IGA 0/1 responses in 48%, 26%, and 29% of subjects, respectively, compared with placebo responses of 9%, 2%, and 2%, respectively, whereas 30 mg once daily is predicted to provide an additional approximately 20% greater efficacy for these end points relative to 15 mg once daily. These analyses supported the selection of upadacitinib doses that are being evaluated in ongoing global phase 3 studies in atopic dermatitis.",2020,"The relationships between upadacitinib plasma exposures and efficacy (assessed as Eczema Area Severity Index (EASI)-75, EASI-90, and Investigator Global Assessment (IGA)0/1) in subjects with moderate to severe AD were characterized using the data from 167 subjects who were enrolled in a Phase 2b dose-ranging study.","['Subjects with Atopic Dermatitis', 'subjects with moderate to severe AD were characterized using the data from 167 subjects who were enrolled in a Phase 2b dose-ranging study']","['monotherapy treatment with upadacitinib extended-release 7.5 mg, 15 mg, 30 mg, or placebo']","['Eczema Area Severity Index (EASI)-75, EASI-90, and Investigator Global Assessment (IGA)0/1', 'EASI-75, EASI-90, and IGA 0/1 responses']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4726929', 'cui_str': 'upadacitinib'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",167.0,0.0395796,"The relationships between upadacitinib plasma exposures and efficacy (assessed as Eczema Area Severity Index (EASI)-75, EASI-90, and Investigator Global Assessment (IGA)0/1) in subjects with moderate to severe AD were characterized using the data from 167 subjects who were enrolled in a Phase 2b dose-ranging study.","[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Sathej', 'Initials': 'S', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH and Co. KG, Germany.'}, {'ForeName': 'Henrique D', 'Initials': 'HD', 'LastName': 'Teixeira', 'Affiliation': 'Immunology Development, AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc, North Chicago, Illinois, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1782']
1365,33157912,Impact of rational emotive behavioral therapy on personal value system of students with visual impairment: A group randomized control study.,"BACKGROUND
Visually impaired students have been reported to struggle with value system and rash decision making process. This study examined the impact of rational emotive behavioral therapy (REBT) in reducing negative personal value system of visually impaired people.
METHOD
A group-randomized trial design was adopted using 56 students with visual impairment. The participants received a value-based rational emotive behavior progamme and were assessed at 3 points using PVS and ABS-2-AV.
RESULTS
The result of analysis of covariance showed that there was no significant difference between the treatment and control groups in initial personal value in Nigerian as measured by PVS. At the post-treatment the effect of V-REBP was significant in personal value and follow-up assessment respectively in favour of treatment group.
CONCLUSION
We concluded that there is significant impact of rational emotive behavioral therapy on reduction of negative personal value system of students with visual impairment.",2020,The result of analysis of covariance showed that there was no significant difference between the treatment and control groups in initial personal value in Nigerian as measured by PVS.,"['students with visual impairment', '56 students with visual impairment', 'visually impaired people']","['rational emotive behavioral therapy (REBT', 'rational emotive behavioral therapy']",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0042798', 'cui_str': 'Dim vision'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]",[],,0.0269281,The result of analysis of covariance showed that there was no significant difference between the treatment and control groups in initial personal value in Nigerian as measured by PVS.,"[{'ForeName': 'Godwin C', 'Initials': 'GC', 'LastName': 'Abiogu', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Moses Onyemaechi', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Fidelis E', 'Initials': 'FE', 'LastName': 'Amaeze', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Ogechi', 'Initials': 'O', 'LastName': 'Nnamani', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Agah', 'Affiliation': 'Department of Science Education University of Nigeria, Nsukka.'}, {'ForeName': 'Clifford E', 'Initials': 'CE', 'LastName': 'Ogheneakoke', 'Affiliation': 'Department of Social Sciences Education, Delta State University Abraka Delta State.'}, {'ForeName': 'Felix O', 'Initials': 'FO', 'LastName': 'Ugwuozor', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Ngozi', 'Initials': 'N', 'LastName': 'Obiyo', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Chukwuemeka', 'Initials': 'C', 'LastName': 'Ezurike', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Nneka', 'Initials': 'N', 'LastName': 'Nwosu', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Obageli C', 'Initials': 'OC', 'LastName': 'Onyeanusi', 'Affiliation': 'Department of Social Sciences Education, University of Nigeria, Nsukka.'}, {'ForeName': 'Maduaka L', 'Initials': 'ML', 'LastName': 'Nweke', 'Affiliation': 'Department of Philosophy, Faculty of Social Sciences, University of Nigeria, Nsukka.'}, {'ForeName': 'Chijioke V', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Asogwa', 'Affiliation': 'Department of Educational Foundations University of Nigeria.'}, {'ForeName': 'Emmanuel I', 'Initials': 'EI', 'LastName': 'Obeagu', 'Affiliation': 'Department of Medical Laboratory Science, Imo State University, Owerri, Imo State, Nigeria.'}, {'ForeName': 'Kelechi R', 'Initials': 'KR', 'LastName': 'Ede', 'Affiliation': 'Department of Agricultural Science Education, University of Nigeria, Nsukka, Nigeria.'}]",Medicine,['10.1097/MD.0000000000022333']
1366,33158633,"The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial.","INTRODUCTION
This single-centered, parallel-groups trial aimed to evaluate the efficacy of traditional corticotomy vs flapless corticotomy in accelerating en-masse retraction. In addition, to assess the skeletal, dental, and soft-tissue variables, as well as the external apical root resorption (EARR) of the maxillary anterior teeth.
METHODS
Forty patients with Class II Division 1 malocclusion aged >18 years at the beginning of treatment, requiring maxillary first premolar extractions, were randomly distributed into 2 groups (n = 20 each): 1 group was treated using traditional corticotomy, and the other group was treated with flapless corticotomy in en-masse retraction with anchorage based on miniscrews placed between maxillary second premolars and first molars bilaterally. Randomization was implemented with a computer-generated list of random numbers; allocation was concealed in sequentially numbered, opaque, sealed envelopes. The study was single-blinded (outcomes' assessor). The primary outcome was the en-masse retraction duration. Secondary outcomes were the skeletal, dental, and soft-tissue changes on lateral cephalometric and the EARR of maxillary anterior teeth on digital panoramic radiographs.
RESULTS
The en-masse retraction duration in the flapless corticotomy group was longer than the traditional corticotomy group. The average retraction duration was 4.04 ± 1.10 months for the flapless corticotomy group and 3.75 ± 2.14 months for the traditional corticotomy group, with no significant difference between the 2 groups (95% confidence interval [CI], -0.81 to 1.39; P = 0.59). No significant differences were observed between the 2 groups regarding changes in several lateral cephalometric variables (eg, SNA angle [95% CI, -2.55° to 1.66°; P = 0.67], SN-U1 angle [95% CI, -1.70° to 1.32°; P = 0.80], and UL-E [95% CI: -1.33 to 1.00 mm; P = 0.78]) or in the amount of EARR in the maxillary anterior teeth (P = 0.31). The proportion of the observed EARR ranged from 1% to 6% of root length in both corticotomy groups. No serious harms were observed in both groups.
CONCLUSIONS
No significant differences between the flapless and traditional corticotomies were found in terms of the skeletal, dental, and soft-tissue variables as well as in the amount of EARR. Corticotomy-assisted en-masse retraction led to improvements in skeletal structures and facial profile and resulted in sufficient retraction of maxillary anterior teeth, slight distal movement of maxillary first molars, and an intrusion movement for both anterior and posterior teeth. Both corticotomy techniques did not cause significant EARR.
REGISTRATION
ClinicalTrials.gov (Identifier: NCT03279042).
PROTOCOL
The protocol was not published before the trial commencement.",2020,"No significant differences were observed between the 2 groups regarding changes in several lateral cephalometric variables (eg, SNA angle [95% CI, -2.55° to 1.66°; P = 0.67], SN-U1 angle [95% CI, -1.70° to 1.32°; P = 0.80], and UL-E [95% CI: -1.33 to 1.00 mm; P = 0.78]) or in the amount of EARR in the maxillary anterior teeth (P = 0.31).","['18\xa0years at the beginning of treatment, requiring maxillary first premolar extractions', 'patients with Class II Division 1 malocclusion', 'Forty patients with Class II Division 1 malocclusion aged']","['traditional corticotomy vs flapless corticotomy', 'traditional corticotomy, and the other group was treated with flapless corticotomy in en-masse retraction with anchorage based on miniscrews placed between maxillary second premolars and first molars bilaterally', 'Corticotomy-assisted en-masse retraction']","['external apical root resorption (EARR) of the maxillary anterior teeth', 'average retraction duration', 'skeletal, dental, and soft-tissue variables', 'flapless and traditional corticotomies', 'skeletal structures and facial profile', 'en-masse retraction duration', 'skeletal, dental, and soft-tissue changes on lateral cephalometric and the EARR of maxillary anterior teeth on digital panoramic radiographs', 'several lateral cephalometric variables']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1290638', 'cui_str': 'Resorption of apex of tooth root'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0424476', 'cui_str': 'Facial profile'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0034579', 'cui_str': 'Orthopantogram'}]",40.0,0.0473728,"No significant differences were observed between the 2 groups regarding changes in several lateral cephalometric variables (eg, SNA angle [95% CI, -2.55° to 1.66°; P = 0.67], SN-U1 angle [95% CI, -1.70° to 1.32°; P = 0.80], and UL-E [95% CI: -1.33 to 1.00 mm; P = 0.78]) or in the amount of EARR in the maxillary anterior teeth (P = 0.31).","[{'ForeName': 'Hanin Nizar', 'Initials': 'HN', 'LastName': 'Khlef', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Mohammad Younis', 'Initials': 'MY', 'LastName': 'Hajeer', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria. Electronic address: myhajeer@gmail.com.'}, {'ForeName': 'Mowaffak A', 'Initials': 'MA', 'LastName': 'Ajaj', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Heshmeh', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Nisreen', 'Initials': 'N', 'LastName': 'Youssef', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus University, Damascus, Syria.'}, {'ForeName': 'Luai', 'Initials': 'L', 'LastName': 'Mahaini', 'Affiliation': 'Department of Orthodontics, University of Damascus Dental School, Damascus University, Damascus, Syria.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.08.008']
1367,33157008,A Prospective Study of Parental Perceptions of Rapid Whole-Genome and -Exome Sequencing among Seriously Ill Infants.,"Rapid diagnostic genomic sequencing recently became feasible for infants in intensive care units (ICUs). However, research regarding parents' perceived utility, adequacy of consent, and potential harms and benefits is lacking. Herein we report results of parental surveys of these domains from the second Newborn Sequencing in Genomic Medicine and Public Health (NSIGHT2) study, a randomized, controlled trial of rapid diagnostic genomic sequencing of infants in regional ICUs. More than 90% of parents reported feeling adequately informed to consent to diagnostic genomic sequencing. Despite only 23% (27) of 117 infants receiving genomic diagnoses, 97% (156) of 161 parents reported that testing was at least somewhat useful and 50.3% (88/161) reported no decisional regret (median 0, mean 10, range 0-100). Five of 117 families (4.3%) reported harm. Upon follow-up, one (1%) confirmed harm to child and parent related to negative results/no diagnosis, two (2%) reported stress or confusion, and two (2%) denied harm. In 81% (89) of 111 infants, families and clinicians agreed that genomic results were useful. Of the families for whom clinicians perceived harm from genomic testing, no parents reported harm. Positive tests/genomic diagnosis were more frequently perceived to be useful by parents, to benefit their infant, and to help manage potential symptoms (p < .05). In summary, the large majority of parents felt that first-tier, rapid, diagnostic genomic sequencing was beneficial for infants lacking etiologic diagnoses in ICUs. Most parents in this study perceived being adequately informed to consent, understood their child's results, and denied regret or harm from undergoing sequencing.",2020,Five of 117 families (4.3%) reported harm.,"['Seriously Ill Infants', 'infants in regional ICUs', 'infants in intensive care units (ICUs']",[],"['Positive tests/genomic diagnosis', 'stress or confusion', 'decisional regret']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0080101', 'cui_str': 'Regret'}]",,0.0554144,Five of 117 families (4.3%) reported harm.,"[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Cakici', 'Affiliation': ""Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA; San Diego State University, School of Public Health, San Diego, CA 92182, USA.""}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dimmock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Caylor', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Gaughran', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Clarke', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Triplett', 'Affiliation': 'The Qualcomm Institute, Calit2, UC San Diego, La Jolla, CA 92093, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Kingsmore', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cinnamon S', 'Initials': 'CS', 'LastName': 'Bloss', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Department of Psychiatry, University of California San Diego, San Diego, CA 92093, USA. Electronic address: cbloss@ucsd.edu.'}]",American journal of human genetics,['10.1016/j.ajhg.2020.10.004']
1368,33160147,Tamoxifen related side effects and their impact on breast cancer incidence: A retrospective analysis of the randomised IBIS-I trial.,"BACKGROUND
Studies in the adjuvant setting have shown that endocrine therapy related side effects predict breast cancer recurrence risk. Here, we assess the relationship between early reported side effects and incidence of breast cancer in women randomised to tamoxifen for cancer prevention in the International Breast Intervention Study (IBIS)-I trial.
METHODS
Women randomised to tamoxifen in the IBIS-I trial and for whom side effect status was known at the 6-month follow-up visit were included in this analysis. Side effects included in this analysis were hot flushes, vaginal discharge, and vaginal dryness. The primary endpoint was all breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer. Cox proportional hazard models were used to investigate breast cancer incidence in the tamoxifen group with and without side effects reported within 6 months of randomisation.
RESULTS
Women randomised to tamoxifen and reporting hot flushes at the 6-month follow-up visit had a non-statistically significant increase in breast cancer compared to those without hot flushes (HR = 1.26 (0.98-1.62), P = 0.08). A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01). A higher risk was observed for ER-positive breast cancer in postmenopausal women (HR = 1.81 (1.19-2.74), P = 0.01). No significant associations between gynaecological side effects and breast cancer occurrence was observed.
CONCLUSIONS
Overall, no association between side effects reported at 6 months and subsequent breast cancer occurrence was observed. Some side effects might be useful markers for breast cancer occurrence in postmenopausal women.",2020,"A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01).","['Women randomised to', 'postmenopausal women']","['tamoxifen', 'Tamoxifen']","['breast cancer incidence', 'breast cancer and secondary endpoint was oestrogen receptor (ER) positive breast cancer', 'gynaecological side effects and breast cancer occurrence', 'breast cancer occurrence', 'hot flushes, vaginal discharge, and vaginal dryness', 'breast cancer', 'breast cancer risk', 'hot flushes']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0825288,"A significant higher breast cancer risk was observed for postmenopausal women who reported hot flushes at the 6-month follow-up visit compared to those without hot flushes (HR = 1.59 (1.12-2.26), P = 0.01).","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hale', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Howell', 'Affiliation': 'Division of Cancer Sciences, University of Manchester, Wilmslow Road, Manchester, M20 4BX, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Ralph Lauren Centre for Breast Cancer Research, London, SW3 6JJ, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Cuzick', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Sestak', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Charterhouse Square, Queen Mary University London, London, EC1M 6BQ, UK. Electronic address: i.sestak@qmul.ac.uk.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.10.015']
1369,33160161,Nitrogen dioxide exposures from LPG stoves in a cleaner-cooking intervention trial.,"BACKGROUND
Liquefied petroleum gas (LPG) stoves have been promoted in low- and middle-income countries (LMICs) as a clean energy alternative to biomass burning cookstoves.
OBJECTIVE
We sought to characterize kitchen area concentrations and personal exposures to nitrogen dioxide (NO 2 ) within a randomized controlled trial in the Peruvian Andes. The intervention included the provision of an LPG stove and continuous fuel distribution with behavioral messaging to maximize compliance.
METHODS
We measured 48-hour kitchen area NO 2 concentrations at high temporal resolution in homes of 50 intervention participants and 50 control participants longitudinally within a biomass-to-LPG intervention trial. We also collected 48-hour mean personal exposures to NO 2 among a subsample of 16 intervention and 9 control participants. We monitored LPG and biomass stove use continuously throughout the trial.
RESULTS
In 367 post-intervention 24-hour kitchen area samples of 96 participants' homes, geometric mean (GM) highest hourly NO 2 concentration was 138 ppb (geometric standard deviation [GSD] 2.1) in the LPG intervention group and 450 ppb (GSD 3.1) in the biomass control group. Post-intervention 24-hour mean NO 2 concentrations were a GM of 43 ppb (GSD 1.7) in the intervention group and 77 ppb (GSD 2.0) in the control group. Kitchen area NO 2 concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants. GM 48-hour personal exposure to NO 2 was 5 ppb (GSD 2.4) among 35 48-hour samples of 16 participants in the intervention group and 16 ppb (GSD 2.3) among 21 samples of 9 participants in the control group.
DISCUSSION
In a biomass-to-LPG intervention trial in Peru, kitchen area NO 2 concentrations were substantially lower within the LPG intervention group compared to the biomass-using control group. However, within the LPG intervention group, 69% of 24-hour kitchen area samples exceeded WHO indoor annual guidelines and 47% of samples exceeded WHO indoor hourly guidelines. Forty-eight-hour NO 2 personal exposure was below WHO indoor annual guidelines for most participants in the LPG intervention group, and we did not measure personal exposure at high temporal resolution to assess exposure to cooking-related indoor concentration peaks. Further research is warranted to understand the potential health risks of LPG-related NO 2 emissions and inform current campaigns which promote LPG as a clean-cooking option.",2020,NO 2 concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants.,"[""96 participants' homes, geometric mean (GM) highest hourly""]","['LPG stove and continuous fuel distribution with behavioral messaging to maximize compliance', 'LPG intervention', 'Post-intervention', 'Liquefied petroleum gas (LPG) stoves', 'Nitrogen dioxide exposures from LPG stoves', 'nitrogen dioxide (NO 2 ']","['24-hour mean', 'NO 2 concentrations']","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0028160', 'cui_str': 'Nitrogen dioxide'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0467508,NO 2 concentrations exceeded the WHO indoor hourly guideline an average of 1.3 h per day among LPG intervention participants.,"[{'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Malpartida', 'Affiliation': 'Molecular Biology and Immunology Laboratory, Research Laboratory of Infectious Diseases, Department of Cell and Molecular Sciences, Faculty of Sciences and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru; Biomedical Research Unit, Asociación Benéfica PRISMA, Lima, Peru.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Howard University, Washington, DC, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Steenland', 'Affiliation': 'Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Luke P', 'Initials': 'LP', 'LastName': 'Naeher', 'Affiliation': 'Department of Environmental Health Science, College of Public Health, The University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Gonzales', 'Affiliation': 'Laboratories of Investigation and Development, Department of Biological and Physiological Sciences, Faculty of Sciences and Philosophy, Universidad Peruana Cayetano Heredia, Lima, Peru; High Altitude Research Institute, Universidad Peruana Cayetano Heredia, Lima, Peru.'}, {'ForeName': 'Marilu', 'Initials': 'M', 'LastName': 'Chiang', 'Affiliation': 'Biomedical Research Unit, Asociación Benéfica PRISMA, Lima, Peru.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Program in Global Disease Epidemiology and Control, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA. Electronic address: wcheckl1@jhmi.edu.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.106196']
1370,33160256,'Everybody's Different: The Appearance Game'. A randomised controlled trial evaluating an appearance-related board game intervention with children aged 9-11 years.,"This study evaluated the effectiveness of an educational board game aimed at increasing knowledge of appearance-related issues, positive body image, media literacy, and acceptance of appearance diversity with British school children. Two hundred and fifty-nine children, aged 9-11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial. Outcome measures were collected pre-, post- and at two-week follow-up. Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up. There were no significant differences between groups for body appreciation, media literacy or acceptance of visible difference. Of the intervention arm, 78 % (n=117) they would like to play again and 85.3 % (n=128) thought other children would like to play. Qualitative data suggests participants learned the key messages of the game. The findings suggest 'Everybody's Different: The Appearance Game' is an enjoyable way to increase knowledge of appearance-related issues. In future, researchers should consider how to increase body appreciation, media literacy and acceptance of appearance diversity, for example by increasing the dosage of the game or using it in conjunction with discussions and lessons surrounding appearance diversity and appearance-altering conditions.",2020,"Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up.","['children aged 9-11 years', 'Two hundred and fifty-nine children, aged 9-11 (Mage = 10.26), from three primary schools in South-West England participated in a two-arm matched cluster randomised controlled trial', 'British school children']","['appearance-related board game intervention', 'educational board game']","['body appreciation, media literacy or acceptance of visible difference']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205379', 'cui_str': 'Visible'}]",259.0,0.051015,"Knowledge of appearance-related issues significantly increased in the intervention group, compared to the control group post-intervention, but was not maintained at follow-up.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guest', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: ella.guest@uwe.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Jarman', 'Affiliation': 'La Trobe University, Melbourne, Victoria, Australia. Electronic address: H.Jarman@latrobe.edu.au.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sharratt', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Nick.Sharratt@uwe.ac.uk.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Williamson', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Heidi3.Williamson@uwe.ac.uk.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Paul.White@uwe.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Harcourt', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Diana2.Harcourt@uwe.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Slater', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK. Electronic address: Amy.Slater@uwe.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}]",Body image,['10.1016/j.bodyim.2020.09.010']
1371,33123862,"The effects of left DLPFC tDCS on emotion regulation, biased attention, and emotional reactivity to negative content.","The potentiation of neural activity in lateral prefrontal regions via transcranial direct current stimulation (tDCS) can reduce patterns of biased attention for threat and may facilitate intentional emotion regulation. The current study sought to determine whether left dorsolateral prefrontal cortex tDCS, in combination with intentional down-regulation of emotional responses would reduce negative appraisals of aversive content during emotional regulation (assessed during online tDCS), reduce patterns of biased attention and attention bias variability (assessed offline), and attenuate spontaneous (uninstructed) emotional reactivity to negative content (assessed offline) above tDCS or intentional down-regulation of emotions in isolation. Healthy participants (n = 116) were allocated to one of four experimental conditions involving either active or sham tDCS, combined with an either a down-regulate or maintain emotion regulation task. Attention bias/bias variability was assessed with an attentional probe task, and emotional reactivity was assessed in a negative video viewing task. tDCS did not affect the appraisals of negative stimuli during emotion regulation, and there were no effects on attention bias/bias variability. However, tDCS did attenuate emotional reactivity. Those receiving active stimulation showed smaller elevations in negative mood in response to viewing aversive video content compared with sham. The present findings are consistent with the potential of left frontal tDCS to attenuate negative emotional reactions to aversive content but provide no support for tDCS enhancement of emotion regulation, nor its impact on attention bias or attention bias variability.",2020,"tDCS did not affect the appraisals of negative stimuli during emotion regulation, and there were no effects on attention bias/bias variability.",['Healthy participants (n = 116'],"['tDCS', 'active or sham tDCS, combined with an either a down-regulate or maintain emotion regulation task', 'transcranial direct current stimulation (tDCS', 'left DLPFC tDCS']","['emotional reactivity', 'emotion regulation, biased attention, and emotional reactivity', 'patterns of biased attention and attention bias variability (assessed offline), and attenuate spontaneous (uninstructed) emotional reactivity to negative content (assessed offline) above tDCS or intentional down-regulation of emotions in isolation', 'attentional probe task, and emotional reactivity', 'appraisals of negative stimuli during emotion regulation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",116.0,0.0943785,"tDCS did not affect the appraisals of negative stimuli during emotion regulation, and there were no effects on attention bias/bias variability.","[{'ForeName': 'Patrick J F', 'Initials': 'PJF', 'LastName': 'Clarke', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia. Patrick.Clarke@curtin.edu.au.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Van Bockstaele', 'Affiliation': 'School of Psychology, University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Welber', 'Initials': 'W', 'LastName': 'Marinovic', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia.'}, {'ForeName': 'Joel A', 'Initials': 'JA', 'LastName': 'Howell', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Boyes', 'Affiliation': 'School of Psychology, Curtin University, Kent St, Bentley, WA, WA 6102, Australia.'}, {'ForeName': 'Lies', 'Initials': 'L', 'LastName': 'Notebaert', 'Affiliation': 'School of Psychology, University of Western Australia, Crawley, Australia.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00840-2']
1372,33126100,A qualitative exploration of mechanisms of intimate partner violence reduction for Zambian couples receiving the Common Elements Treatment Approach (CETA) intervention.,"RATIONALE
Despite well-established associations between alcohol use, poor mental health, and intimate partner violence (IPV), limited attention has been given to how psychological and behavioral interventions might prevent or treat IPV in low- and middle-income countries.
OBJECTIVE
In a recent randomized controlled trial in Lusaka, Zambia, transdiagnostic cognitive-behavioral psychotherapy (the Common Elements Treatment Approach; CETA) demonstrated significant treatment effects on men's alcohol use and women's IPV victimization in couples in which hazardous alcohol use by the male and intimate partner violence against the female was reported. In this study, we sought to gain a more in-depth understanding of mechanisms of behavior change among CETA participants.
METHODS
We conducted 50 semi-structured in-depth interviews and 4 focus groups with a purposeful sample of adult men and women who received CETA between April and October 2018. Transcripts were analyzed using an inductive constant comparison approach by a team of US- and Zambia-based coders.
RESULTS
Participants described interrelated mechanisms of change, including the use of safety strategies to not only avoid or prevent conflict but also to control anger; reductions in alcohol use that directly and indirectly reduced conflict; and, positive changes in trust and understanding of one's self and their partner. Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
CONCLUSIONS
Results suggest important avenues for future research including the potential for combining CETA with poverty reduction or gender norms focused interventions and for incorporating cognitivebehavioral skills into community level interventions.",2020,"Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
","['CETA participants', ""men's alcohol use and women's IPV victimization in couples in which hazardous alcohol use by the male and intimate partner violence against the female"", '50 semi-structured in-depth interviews and 4 focus groups with a purposeful sample of adult men and women who received CETA between April and October 2018', 'zambian couples receiving the Common Elements Treatment Approach (CETA) intervention']",[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],[],,0.0260064,"Several overarching themes also emerged from the data: how gender norms shaped participants' understanding of violence reduction strategies; the role of household economics in cycles of alcohol and violence; and, deleterious and virtuous intercouple dynamics that could perpetuate or diminish violence.
","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA. Electronic address: Sarah.murray@jhu.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Skavenski Van Wyk', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metz', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Saphira Munthali', 'Initials': 'SM', 'LastName': 'Mulemba', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), USA.'}, {'ForeName': 'Mwamba M', 'Initials': 'MM', 'LastName': 'Mwenge', 'Affiliation': 'Serenity Harm Reduction Programme Zambia (SHARPZ), USA.'}, {'ForeName': 'Jeremy C', 'Initials': 'JC', 'LastName': 'Kane', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Alto', 'Affiliation': 'University of Rochester, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Venturo-Conerly', 'Affiliation': 'Department of Psychology, Harvard University, USA.'}, {'ForeName': 'Akash R', 'Initials': 'AR', 'LastName': 'Wasil', 'Affiliation': 'Department of Psychology, Harvard University, USA.'}, {'ForeName': 'Shoshanna L', 'Initials': 'SL', 'LastName': 'Fine', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113458']
1373,33127493,The Risk of Subclinical Breast Cancer-Related Lymphedema by the Extent of Axillary Surgery and Regional Node Irradiation: A Randomized Controlled Trial.,"PURPOSE
To compare the risk of subclinical breast cancer-related lymphedema (sBCRL) using bioimpedance spectroscopy (BIS) or tape measure (TM) by the extent of axillary surgery and regional nodal irradiation (RNI).
METHODS AND MATERIALS
Patients were randomized to surveillance with TM or BIS. A BIS ≥6.5 L-Dex units or TM volume change ≥5 and <10% above presurgical baselines ""triggered"" sBCRL. The incidence of sBCRL by sentinel node biopsy or axillary lymph node dissection (ALND) with or without RNI was examined for 484 patients. Radiation was categorized as ""limited RNI"" (axilla level I/II only) or ""extensive RNI"" (axilla level III or supraclavicular fossa with or without level I/II).
RESULTS
At a median follow-up of 20.5 months, 109 of 498 patients (21.9%) triggered sBCRL (BIS 13.5% vs TM 25.6%; P <.001). In patients not receiving RNI, BIS triggered 12.9% of patients undergoing SNB and 25.0% undergoing ALND (P = .18). Extensive RNI significantly increased triggering with BIS versus no RNI after sentinel node biopsy (SNB; 33.3% vs 12.9%; P = .03) but not ALND (30.8% vs 25.0%; P = .69). Triggering by TM was greater than 25% for most subgroups and was inferior to BIS in discriminating the risk of sBCRL by utilization of RNI or axillary surgery.
CONCLUSIONS
The lower triggering rates with BIS and its better discrimination of the risk of sBCRL by receipt and type of RNI compared with TM support its use for posttreatment surveillance to detect sBCRL and to initiate early intervention. The risk of sBCRL increased with more extensive axillary treatment. Patients having ALND or extensive RNI require close surveillance for BCRL. Longer follow-up is required to determine rates of progression to clinical lymphedema.",2020,"Triggering by TM was over 25% for most subgroups and was inferior to BIS in discriminating the risk of sBCRL by utilization of RNI or axillary surgery.
","['Patients having ALND or extensive RNI require close surveillance for BCRL', '484 patients', 'Patients were randomized to surveillance with']","['TM or BIS', 'Bioimpedance Spectroscopy (BIS) or Tape-Measure (TM) by the extent of axillary surgery and regional nodal irradiation (RNI']","['incidence of sBCRL by sentinel node biopsy (SNB) or axillary lymph node dissection (ALND) ', 'risk of sBCRL', 'risk of subclinical breast cancer-related lymphedema (sBCRL']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0851211,"Triggering by TM was over 25% for most subgroups and was inferior to BIS in discriminating the risk of sBCRL by utilization of RNI or axillary surgery.
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boyages', 'Affiliation': 'Australian Lymphedema Education, Research and Treatment program, Macquarie University, Sydney, Australia; Icon Cancer Centre, Wahroonga, New South Wales, Australia. Electronic address: john.boyages@icon.team.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Vicini', 'Affiliation': 'Michigan Healthcare Professionals, 21St Century Oncology, Farmington Hills, Michigan.'}, {'ForeName': 'Chirag', 'Initials': 'C', 'LastName': 'Shah', 'Affiliation': 'Cleveland Clinic, Taussig Cancer Institute, Department of Radiation Oncology, Cleveland, Ohio.'}, {'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Koelmeyer', 'Affiliation': 'Australian Lymphedema Education, Research and Treatment program, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jerrod A', 'Initials': 'JA', 'LastName': 'Nelms', 'Affiliation': 'TTi Health Research and Economics, Westminster, Maryland.'}, {'ForeName': 'Sheila H', 'Initials': 'SH', 'LastName': 'Ridner', 'Affiliation': 'School of Nursing, Vanderbilt University, Nashville, Tennessee.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.10.024']
1374,33129962,"The efficacy of midline catheters-a prospective, randomized, active-controlled study.","OBJECTIVES
This study was performed to investigate whether an intravenous (IV) strategy based on new-generation midline catheters is an efficacious alternative to a conventional IV strategy consisting of peripheral venous catheters and central venous catheters, for patients needing IV therapy exceeding 5 days.
METHODS
This was a prospective, randomized, controlled study. Patients requiring more than 5 days of IV treatment were randomized to either a midline catheter-based IV strategy or a conventional strategy. The primary endpoint was the composite of the insertion of a central venous catheter (CVC) or the need for four or more peripheral venous catheter (PVC) insertions. The secondary outcomes included catheter dwell times and reasons for premature removal.
RESULTS
One hundred and twenty patients were included. The fraction of patients receiving four or more PVCs or having a CVC inserted was 12/58 (21%) in the midline group versus 38/58 (66%) in the conventional group (p < 0.001); the number needed to treat was 2.2. The median overall catheter dwell time was 7 days (range 0-60 days) in the midline group and 4 days (range 0-84 days) in the conventional group (p = 0.002).
CONCLUSION
In patients requiring more than 5 days of IV therapy, a midline catheter strategy reduced the need for insertion of a CVC or four or more PVCs.",2020,"Median overall catheter dwell times were 7 days (0-60 days) and 4 days (0-84 days) in the midline- and conventional groups, respectively (P = 0.002).
","['Patients requiring more than five days IV treatment', '120 patients were included', 'patients needing IV therapy exceeding five days']","['midline catheters', 'midline catheter based IV strategy or a conventional strategy']","['Median overall catheter dwell times', 'catheter dwell times and reasons for premature removal', 'composite of the insertion of a CVC or the need for\u2009≥\u2009four PVC insertions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0032624', 'cui_str': 'Polyvinyl chloride'}]",120.0,0.166851,"Median overall catheter dwell times were 7 days (0-60 days) and 4 days (0-84 days) in the midline- and conventional groups, respectively (P = 0.002).
","[{'ForeName': 'Emma Bundgaard', 'Initials': 'EB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Antonsen', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Mensel', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Nikolaj', 'Initials': 'N', 'LastName': 'Milandt', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Lars Skov', 'Initials': 'LS', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Medicine, The Regional Hospital West Jutland, Gl. Landevej 72, 7400 Herning, Denmark.'}, {'ForeName': 'Britta Skov', 'Initials': 'BS', 'LastName': 'Illum', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Arildsen', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Juhl-Olsen', 'Affiliation': 'Department of Anesthesiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark; Institute for Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 82, 8200 Aarhus N, Denmark. Electronic address: olsen@clin.au.dk.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.10.053']
1375,33130147,Variability in Blood Eosinophil Counts in Patients with Eosinophilic Asthma.,"BACKGROUND
Blood eosinophil (EOS) counts are critical to the accurate identification of asthma phenotypes. However, there are few long-term data on intraindividual EOS count variability among patients with eosinophilic asthma.
OBJECTIVE
This post hoc analysis of 2 phase III clinical trials from the reslizumab BREATH program explored the variability of blood EOS counts in patients with eosinophilic asthma receiving placebo.
METHODS
Pooled data from study participants receiving placebo (previously randomized 1:1 to receive reslizumab or placebo) were analyzed for blood EOS count variability over 52 weeks. EOS counts were measured up to twice during screening, every 4 weeks from randomization to the end of treatment and at the 90-day follow-up visit.
RESULTS
Of 476 included patients, 31 (6.5%), 38 (8.0%), 55 (11.6%), and 352 (73.9%) patients had baseline blood EOS counts of <150, ≥150 to <300, ≥300 to <400, and ≥400 cells/μL, respectively. Patients frequently shifted between EOS count categories during the 52-week treatment period, most often moving to the highest EOS category. Among patients in each of the lower 3 EOS categories, 27% to 56% of patients shifted to the ≥400 cells/μL category at some point during the treatment period.
CONCLUSION
Intraindividual variability in blood EOS count was high among patients with eosinophilic asthma receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed. Repeat determinations of blood EOS count may be important to ensure appropriate selection of therapy in patients with severe asthma.",2020,"CONCLUSION
Intra-individual variability in blood EOS count was high among eosinophilic asthma patients receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed.","['Pooled data from study participants receiving', 'patients with eosinophilic asthma receiving placebo', 'patients with eosinophilic asthma', 'patients with severe asthma', 'Patients with Eosinophilic Asthma', 'eosinophilic asthma patients receiving']","['reslizumab BREATH program', 'reslizumab or placebo', 'placebo']","['EOS counts', 'blood EOS counts', 'Blood Eosinophil Counts', 'blood EOS count', 'blood EOS count variability', 'baseline blood EOS counts']","[{'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034068', 'cui_str': 'Eosinophilic asthma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",476.0,0.133089,"CONCLUSION
Intra-individual variability in blood EOS count was high among eosinophilic asthma patients receiving placebo, with shifts to ≥400 cells/μL from lower categories frequently observed.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Corren', 'Affiliation': 'Division of Clinical Immunology and Allergy, David Geffen School of Medicine at University of California, Los Angeles, Calif. Electronic address: jcorren@ucla.edu.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Du', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, Pa.'}, {'ForeName': 'Ananda', 'Initials': 'A', 'LastName': 'Gubbi', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, Pa.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Vanlandingham', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D Inc., West Chester, Pa.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.033']
1376,33136966,Targeted Muscle Reinnervation as a Solution for Nerve Pain.,"LEARNING OBJECTIVES
After reading this article, the participants should be able to: 1. List current nonsurgical and surgical strategies for addressing postamputation neuroma pain and discuss their limitations. 2. Summarize the indications and rationale for targeted muscle reinnervation. 3. Develop an operative plan for targeted muscle reinnervation in an acute or delayed fashion for upper and lower extremity amputations. 4. Propose a management algorithm for treatment of symptomatic neuromas in an intact limb. 5. Discuss the risk of neuroma development after primary revision digital amputation or secondary surgery for a digital neuroma. 6. Compare and contrast targeted muscle reinnervation to the historical gold standard neuroma treatment of excision and burying the involved nerve in muscle, bone, or vein graft. 7. Interpret and discuss the evidence that targeted muscle reinnervation improves postamputation neuroma and phantom pain when performed either acutely or in a delayed fashion to treat existing pain.
SUMMARY
Symptomatic injured nerves resulting from amputations, extremity trauma, or prior surgery are common and can decrease patient quality of life, thus necessitating an effective strategy for management. Targeted muscle reinnervation is a modern surgical strategy for prevention and treatment of neuroma pain that promotes nerve regeneration and healing rather than neuroma formation. Targeted muscle reinnervation involves the transfer of cut peripheral nerves to small motor nerves of adjacent, newly denervated segments of muscle and can be easily performed without specialized equipment. Targeted muscle reinnervation strategies exist for both upper and lower extremity amputations and for symptomatic neuromas of intact limbs. Targeted muscle reinnervation has been shown in a prospective, randomized, controlled trial to result in lower neuroma and phantom pain when compared to the historical gold standard of burying cut nerves in muscle.",2020,Targeted muscle reinnervation strategies exist for both upper and lower extremity amputations and for symptomatic neuromas of intact limbs.,['primary revision digital amputation or secondary surgery for a digital neuroma'],[],['patient quality of life'],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027858', 'cui_str': 'Neuroma'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0280288,Targeted muscle reinnervation strategies exist for both upper and lower extremity amputations and for symptomatic neuromas of intact limbs.,"[{'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'Lanier', 'Affiliation': 'Chicago, Ill. From the Division of Plastic Surgery, Department of Surgery, Northwestern University Feinberg School of Medicine.'}, {'ForeName': 'Sumanas W', 'Initials': 'SW', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Jason H', 'Initials': 'JH', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Dumanian', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007235']
1377,33137579,"Supporting Play, Exploration, and Early Development Intervention (SPEEDI) for preterm infants: A feasibility randomised controlled trial in an Australian context.","BACKGROUND
An early intervention that enhances early development in infants born preterm, called 'Supporting Play, Exploration and Early Development Intervention' (SPEEDI) has been shown to be feasible in Virginia, United States, in a pilot study. Infants receive 10 therapy sessions until 3 months' corrected age (CA) (Phase 1[5 hospital sessions] and Phase 2[5 home-based sessions]) in addition to usual care.
AIMS
To determine the feasibility of SPEEDI for very preterm infants in an Australian context.
STUDY DESIGN
Prospective pilot feasibility randomised controlled trial.
SUBJECTS
Infants born <30 weeks' gestation (GA), recruited between 34 and 38 +6 weeks' postmenstrual age.
OUTCOME MEASURES
Primary outcome was feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity. Secondary outcome measures were developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4 months' CA.
RESULTS
Of 19 eligible infants, 17 consented, SPEEDI n = 8 and usual care n = 9 (mean GA = 26.7 weeks [SD 1.4], male n = 10). All participants completed the study, with 80% of SPEEDI therapy sessions completed (90% Phase 1; 72% Phase 2). On average, therapists and parents used 78% and 77% of SPEEDI strategies in each session respectively. Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
CONCLUSIONS
SPEEDI is a feasible intervention to deliver, and preliminary results suggest that SPEEDI may lead to improved motor and language outcomes at 4 months' CA, with results supporting future larger clinical trials.",2020,"Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
","['preterm infants', ""Infants born <30\xa0weeks' gestation (GA), recruited between 34 and 38 +6 weeks' postmenstrual age"", 'infants born preterm', 'very preterm infants in an Australian context', '19 eligible infants, 17 consented, SPEEDI n\xa0=\xa08 and usual care']",[],"['feasibility of SPEEDI, including recruitment rate, participant retention, sessions delivered, and therapy fidelity', ""developmental outcomes, including the Bayley Scales of Infant and Toddler Development - 3rd Edition (BSID-III) at 4\xa0months' CA"", 'BSID-III for gross motor, and expressive and receptive language subscales']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0023008', 'cui_str': 'Language'}]",19.0,0.112813,"Infants in the SPEEDI group had higher scores on the BSID-III for gross motor, and expressive and receptive language subscales at 4 months' CA.
","[{'ForeName': 'Francyne', 'Initials': 'F', 'LastName': 'Finlayson', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia. Electronic address: fsamara@student.unimelb.edu.au.""}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Olsen', 'Affiliation': ""Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Dusing', 'Affiliation': 'University of Southern California, 1540 Alcazar St #155, Los Angeles, California 90033, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Guzzetta', 'Affiliation': 'IRCCS Fondazione Stella Maris, Viale del Tirreno, 331, 56128 Calambrone, Pisa, Italy.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Eeles', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; Murdoch Children's Research Institute, 50 Flemington Rd, Parkville, Victoria 3052, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Spittle', 'Affiliation': ""The University of Melbourne, 161 Barry St, Carlton, Victoria 3053, Australia; The Royal Women's Hospital, 20 Flemington Rd, Parkville, Victoria 3052, Australia.""}]",Early human development,['10.1016/j.earlhumdev.2020.105172']
1378,33137580,A breastfeeding support program changed breastfeeding patterns but did not affect the mothers' self-efficacy in breastfeeding at two months.,"BACKGROUND
Even though the biological norm in humans is frequent on demand breastfeeding, sparse feeding intervals have become the cultural norm in most Western countries due to a history of on schedule breastfeeding. This discrepancy between the biological basis and the culturally driven practice continues to interfere with women's ability to breastfeed.
AIM
Our aim was to describe breastfeeding patterns in 2-month-old infants before and after the implementation of a breastfeeding support program. A secondary aim was to investigate the relationship between breastfeeding patterns and the mother's self-efficacy in breastfeeding.
METHODS
The study had a baseline/intervention design and was part of a larger project aiming to revive the Ten Steps to Successful Breastfeeding program. The larger project included breastfeeding training for health care professionals and provision of breastfeeding information to parents, including information about on demand breastfeeding. Data were gathered via breastfeeding diaries (n = 79 mothers from each group) and the Breastfeeding Self-efficacy Scale-Short Form (n = 83 in the baseline group and n = 79 in the intervention group).
RESULTS
On demand breastfeeding patterns were more common in the intervention group (97.5%) than in the baseline group (74.7%) (p < 0.001), and breastfeeding sessions were more frequent in the intervention group (a median of 14 times per 24 h versus 11 times in the baseline group; p = 0.026). Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
CONCLUSIONS
Knowledge about infants' breastfeeding behavior can strengthen on demand breastfeeding. Exclusive breastfeeding is associated with higher self-efficacy.",2020,"Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
",['mothers with exclusive breastfeeding'],['breastfeeding training'],"['Self-efficacy', 'breastfeeding sessions', 'Breastfeeding Self-efficacy Scale-Short Form']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",,0.0233632,"Self-efficacy in breastfeeding did not differ between the groups, but was higher in mothers with exclusive breastfeeding.
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Oras', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden. Electronic address: paola.oras@kbh.uu.se.""}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Ljungberg', 'Affiliation': 'Psychiatric Clinic, Nyköping Hospital, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hellström-Westas', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Eva-Lotta', 'Initials': 'EL', 'LastName': 'Funkquist', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}]",Early human development,['10.1016/j.earlhumdev.2020.105242']
1379,33137581,Does focus of attention alter craniocervical flexion test motor learning? A randomized controlled trial.,"OBJECTIVE
To evaluate the effects of three different foci of attention (internal, external and mixed) on motor learning using craniocervical flexion test in inexperienced participants.
METHODS
Ninety healthy young adults, with no experience in the task, practiced the craniocervical flexion test under three different focus of attention: a) Mixed Focus (internal plus external), b) Internal Focus, and c) External Focus. We assessed immediate, post-training, and retention (one week after the last training session) aspects of motor learning by quantifying (i) the activity of the superficial cervical flexors muscles, (ii) craniocervical range of motion, and (iii) the performance on the craniocervical flexion test.
RESULTS
None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression. At immediate assessment, mixed focus had greater craniocervical flexion performance than external (MD 0.9, 95%CI 0.2 to 1.5), and internal foci (MD 1.4, 95%CI 0.8 to 2.1). At post-training, mixed focus led to better craniocervical performance compared to external (MD 1.6, 95%CI 0.8 to 2.4) and internal foci (MD 2.7, 95%CI 1.9 to 3.5). External focus had better scores on the craniocervical flexion test performance than internal focus (MD 1.1, 95%CI 0.3 to 1.9). Results remained similar at retention, with mixed focus being superior to internal (MD 2.3, 95%CI 1.7 to 3) and external foci (MD 1.5, 95%CI 0.9 to 2.1) on craniocervical flexion test performance. Similarly, the performance on the craniocervical flexion test performance remained similar at retention between external and internal foci (MD 0.9, 95%CI 0.2 to 1.5).
CONCLUSION
In inexperienced asymptomatic participants, different foci of attention were not able to change cervical muscle activity and craniocervical range of motion during the craniocervical flexion test. Mixed focus was better than external and internal focus on the craniocervical flexion test. These findings were retained after one week.",2020,"None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression.","['Ninety healthy young adults, with no experience in the task, practiced the craniocervical flexion test under three different focus of attention: a', 'inexperienced participants']","['motor learning by quantifying (i) the activity of the superficial cervical flexors muscles, (ii) craniocervical range of motion, and (iii) the performance on the craniocervical flexion test', 'Mixed Focus (internal plus external), b) Internal Focus, and c', 'foci of attention (internal, external and mixed']","['craniocervical flexion performance', 'superficial neck flexors activity and craniocervical range of motion progression', 'craniocervical performance', 'craniocervical flexion test performance']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}]",90.0,0.05819,"None of the groups showed any significant immediate, post-training, or retention effects on superficial neck flexors activity and craniocervical range of motion progression.","[{'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Scholl Schell', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. Electronic address: mauriciosc@ufcpsa.edu.br.'}, {'ForeName': 'Francisco Xavier', 'Initials': 'FX', 'LastName': 'de Araujo', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Physical Therapy Department, Centro Universitário Ritter dos Reis - UniRitter, Porto Alegre, Brazil.'}, {'ForeName': 'Rosicler', 'Initials': 'R', 'LastName': 'da Rosa Almeida', 'Affiliation': 'Physical Therapy Department, Undergraduate Program, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Brazil.'}, {'ForeName': 'Ian Sulzbacher', 'Initials': 'IS', 'LastName': 'Peroni', 'Affiliation': 'Physical Therapy Department, Undergraduate Program, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Brazil.'}, {'ForeName': 'Carolina Gomes', 'Initials': 'CG', 'LastName': 'Rosa', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Marcelo Faria', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Physical Therapy Department, Post Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil; Physical Therapy Department, Post Graduate Program in Health Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. Electronic address: marcelofs@ufcspa.edu.br.'}]",Human movement science,['10.1016/j.humov.2020.102709']
1380,33139537,Antibody-mediated activation of the FGFR1/Klothoβ complex corrects metabolic dysfunction and alters food preference in obese humans.,"Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ (FGFR1/KLB) complexes expressed in adipocytes, pancreatic acinar cells, and the nervous system in mice. Chronic administration of recombinant FGF21 or engineered variants improves metabolic health in rodents, nonhuman primates, and humans; however, the rapid turnover of these molecules limits therapeutic utility. Here we show that the bispecific anti-FGFR1/KLB agonist antibody BFKB8488A induced marked weight loss in obese cynomolgus monkeys while elevating serum adiponectin and the adipose expression of FGFR1 target genes, demonstrating its action as an FGF21 mimetic. In a randomized, placebo-controlled, single ascending-dose study in overweight/obese human participants, subcutaneous BFKB8488A injection caused transient body weight reduction, sustained improvement in cardiometabolic parameters, and a trend toward reduction in preference for sweet taste and carbohydrate intake. These data suggest that specific activation of the FGFR1/KLB complex in humans can be used as therapy for obesity-related metabolic defects.",2020,Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ,"['obese humans', 'overweight/obese human participants']","['subcutaneous BFKB8488A injection', 'placebo', 'FGFR1/Klothoβ complex', 'recombinant FGF21', 'bispecific anti-FGFR1/KLB agonist antibody BFKB8488A']","['metabolic health', 'marked weight loss', 'Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0060369', 'cui_str': 'Fibroblast Growth Factor Receptors'}]",,0.0201048,Fibroblast growth factor 21 (FGF21) controls metabolic organ homeostasis and eating/drinking behavior via FGF receptor 1/Klothoβ,"[{'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Baruch', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Leslie W', 'Initials': 'LW', 'LastName': 'Chinn', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Vaze', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Junichiro', 'Initials': 'J', 'LastName': 'Sonoda', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gelzleichter', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lewin-Koh', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Morrow', 'Affiliation': 'ProSciento, Inc., Chula Vista, CA 91911.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Dheerendra', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Boismenu', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Gutierrez', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Wakshull', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Wilson', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080.'}, {'ForeName': 'Puneet S', 'Initials': 'PS', 'LastName': 'Arora', 'Affiliation': 'Genentech Research and Early Development, Genentech, Inc., South San Francisco, CA 94080; puneetarora.md@gmail.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2012073117']
1381,33141327,"Impact of a school-based water, sanitation and hygiene programme on children's independent handwashing and toothbrushing habits: a cluster-randomised trial.","OBJECTIVES
To explore whether a school-based water, sanitation and hygiene programme, which includes group hygiene activities, contributes to the formation of independent handwashing and toothbrushing habits among Filipino children.
METHODS
In this cluster-randomised trial, twenty primary schools were randomly allocated to the intervention or control arm. Intervention schools received group handwashing facilities and implemented daily group handwashing and toothbrushing activities. A soap use to toilet event ratio was calculated to measure children's independent handwashing behaviour after toilet use, and dental plaque accumulation on Monday morning was measured as a proxy indicator for children's independent toothbrushing behaviour at home.
RESULTS
Four months after implementation, handwashing and toothbrushing behaviours did not significantly differ between intervention and control schools. The mean soap use in intervention schools and control schools was 0.41 g and 0.30 g per toilet event, respectively (p = 0.637). Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857).
CONCLUSIONS
Although health benefits have been established, school-based group handwashing and toothbrushing may not be sufficient to increase children's uptake of independent hygiene behaviours.",2020,"Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857).
","['twenty primary schools', ""children's independent handwashing and toothbrushing habits""]","['school-based water, sanitation and hygiene programme', 'group handwashing facilities and implemented daily group handwashing and toothbrushing activities']","['handwashing and toothbrushing behaviours', 'mean plaque scores']","[{'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0493894,"Compared to baseline, mean plaque scores reduced by 4.2% and 3.5% in intervention and control schools, respectively (p = 0.857).
","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Duijster', 'Affiliation': 'Department of Social Dentistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU Universiteit Amsterdam, Amsterdam, The Netherlands. D.Duijster@acta.nl.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Buxton', 'Affiliation': 'Disease Control Department, School of Hygiene and Tropical Medicine London, London, UK.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Benzian', 'Affiliation': 'Department of Epidemiology and Health Promotion, WHO Collaborating Center for Quality Improvement and Evidence-based Dentistry, College of Dentistry, New York University, New York, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Dimaisip-Nabuab', 'Affiliation': 'Gesellschaft für Internationale Zusammenarbeit (GIZ), Metro Manila, Philippines.'}, {'ForeName': 'Bella', 'Initials': 'B', 'LastName': 'Monse', 'Affiliation': 'Gesellschaft für Internationale Zusammenarbeit (GIZ), Metro Manila, Philippines.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Volgenant', 'Affiliation': 'Department of Preventive Dentistry, Academic Centre for Dentistry Amsterdam, University of Amsterdam and VU Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreibelbis', 'Affiliation': 'Disease Control Department, School of Hygiene and Tropical Medicine London, London, UK.'}]",International journal of public health,['10.1007/s00038-020-01514-z']
1382,33143532,Neural effects of a single dose of fluoxetine on resting-state functional connectivity in adolescent depression.,"Fluoxetine is commonly prescribed in adolescent depression, but the neural mechanisms underlying its action remain poorly understood. Here, we used resting-state functional magnetic resonance imaging to investigate the effects of a single dose of fluoxetine vs. placebo in adolescents with major depressive disorder. In contrast with previous studies in adults that have demonstrated an acute effect of antidepressants on activity within the default mode network, a single dose of fluoxetine did not alter activity in this network in adolescent depression. There were unexpected group activity differences in the motor network, which should be clarified in future research.",2020,"There were unexpected group activity differences in the motor network, which should be clarified in future research.","['adolescents with major depressive disorder', 'adolescent depression']","['fluoxetine', 'Fluoxetine', 'fluoxetine vs. placebo']",['resting-state functional connectivity'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0367822,"There were unexpected group activity differences in the motor network, which should be clarified in future research.","[{'ForeName': 'Liliana P', 'Initials': 'LP', 'LastName': 'Capitão', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chapman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Filippini', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susannah E', 'Initials': 'SE', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'James', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Phil J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120959608']
1383,33143538,Does anxiety moderate the effectiveness of mirtazapine in patients with treatment-resistant depression? A secondary analysis of the MIR trial.,"BACKGROUND
There is a lack of evidence to guide treatment of comorbid depression and anxiety. Preliminary evidence suggests mirtazapine may be effective in treating patients with both depression and anxiety symptoms.
METHODS
We undertook a secondary analysis of mirtazapine (MIR): a placebo-controlled trial of the addition of mirtazapine to a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor in treatment-resistant depression (TRD) in primary care. We subdivided participants into three groups by baseline generalized anxiety disorder score (GAD-7): severe (GAD-7 ⩾ 16), moderate (GAD-7 = 11-15), no/mild (GAD-7 ⩽ 10). We used linear regression including likelihood-ratio testing of interaction terms to assess how baseline anxiety altered the response of participants to mirtazapine as measured by 12-week GAD-7 and Beck Depression Inventory II (BDI-II) scores.
RESULTS
Baseline generalized anxiety moderated mirtazapine's effect as measured by GAD-7 ( p = 0.041) and BDI-II ( p = 0.088) at 12 weeks. Participants with severe generalized anxiety receiving mirtazapine had lower 12-week GAD-7 score (adjusted difference between means (ADM) -2.82, 95% confidence interval (CI) -0.69 to -4.95) and larger decreases in BDI-II score (ADM -6.36, 95% CI -1.60 to -10.84) than placebo. Conversely, there was no anxiolytic benefit (ADM 0.28, 95% CI -1.05 to 1.60) or antidepressant benefit (ADM -0.17, 95% CI -3.02 to 2.68) compared with placebo in those with no/mild generalized anxiety.
CONCLUSIONS
These findings extend the evidence for the effectiveness of mirtazapine to reduce generalized anxiety in TRD in primary care. These results may inform targeted prescribing in depression based on concurrent anxiety symptoms, although these conclusions are constrained by the post-hoc nature of this analysis.",2020,"Conversely, there was no anxiolytic benefit (ADM 0.28, 95% CI -1.05 to 1.60) or antidepressant benefit (ADM -0.17, 95% CI -3.02 to 2.68) compared with placebo in those with no/mild generalized anxiety.
","['Participants with severe generalized anxiety receiving', 'GAD-7 ⩾ 16), moderate (GAD-7 = 11-15), no/mild (GAD-7 ⩽ 10', 'patients with both depression and anxiety symptoms', 'patients with treatment-resistant depression']","['mirtazapine (MIR', 'placebo', 'mirtazapine']","['generalized anxiety disorder score (GAD-7): severe', '12-week GAD-7 and Beck Depression Inventory II (BDI-II) scores', 'anxiolytic benefit', 'BDI-II score', 'GAD-7 score', 'generalized anxiety']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0049506', 'cui_str': 'Mirtazapine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C4273555', 'cui_str': 'Beck Depression Inventory II score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.2179,"Conversely, there was no anxiolytic benefit (ADM 0.28, 95% CI -1.05 to 1.60) or antidepressant benefit (ADM -0.17, 95% CI -3.02 to 2.68) compared with placebo in those with no/mild generalized anxiety.
","[{'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Rifkin-Zybutz', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'MacNeill', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Simon Jc', 'Initials': 'SJ', 'LastName': 'Davies', 'Affiliation': 'Centre for Addiction and Mental Health, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Dickens', 'Affiliation': 'Mental Health Research Group, University of Exeter, Exeter, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Academic Primary Care, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Anderson', 'Affiliation': 'Neuroscience and Psychiatry Unit, University of Manchester, Manchester, UK.'}, {'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Chew-Graham', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'Centre for Academic Mental Health, Bristol Medical School, University of Bristol, Bristol, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120965939']
1384,33150640,Mediators of change in cognitive behavior therapy and interpersonal psychotherapy for eating disorders: A secondary analysis of a transdiagnostic randomized controlled trial.,"OBJECTIVE
Understanding the mechanisms of action of psychological treatments is a key first step in refining and developing more effective treatments. The present study examined hypothesized mediators of change of enhanced cognitive behavior therapy (CBT-E) and interpersonal psychotherapy for eating disorders (IPT-ED).
METHOD
A series of mediation studies were embedded in a randomized controlled trial (RCT) comparing 20 weeks of CBT-E and IPT-ED in a transdiagnostic, non-underweight sample of patients with eating disorders (N = 130) consecutively referred to the service. Three hypothesized mediators of change in CBT-E (regular eating, weighing frequency, and shape checking) and the key hypothesized mediator of IPT-ED (interpersonal problem severity) were studied.
RESULTS
The data supported regular eating as being a mediator of the effect of CBT-E on binge-eating frequency. The findings were inconclusive regarding the role of the other putative mediators of the effects of CBT-E; and were similarly inconclusive for interpersonal problem severity as a mediator of the effect of IPT-ED.
DISCUSSION
This research highlights the potential benefits of embedding mediation studies within RCTs to better understand how treatments work. The findings supported the role of regular eating in reducing patients' binge-eating frequency. Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them. Key methodological issues to address in future work include the need to capture both behavioral and cognitive processes of change in CBT-E, and identifying key time points for change in IPT-ED.",2020,"Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them.","['patients with eating disorders (N =\u2009130) consecutively referred to the service', 'eating disorders']","['cognitive behavior therapy and interpersonal psychotherapy', 'CBT-E and IPT-ED', 'enhanced cognitive behavior therapy (CBT-E) and interpersonal psychotherapy']","['CBT-E (regular eating, weighing frequency, and shape checking']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}]",,0.0519678,"Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them.","[{'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Sivyer', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Zafra', 'Initials': 'Z', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bailey-Straebler', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Marianne E', 'Initials': 'ME', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychiatry, Oxford University, Oxford, UK.'}]",The International journal of eating disorders,['10.1002/eat.23390']
1385,33150711,"Electrophysiologically verified effects of acupuncture on diabetic peripheral neuropathy in type 2 diabetes: The randomized, partially double-blinded, controlled ACUDIN trial.","BACKGROUND
Acupuncture is commonly used in Traditional Chinese Medicine for treatment of diabetic peripheral neuropathy (DPN), but data from randomized controlled trials are rare.
METHODS
This randomized, placebo-controlled, partially double-blinded clinical trial randomly assigned adults with confirmed type 2 diabetes-induced DPN to receive 10 sessions of needle acupuncture, laser acupuncture, or placebo laser acupuncture for 10 consecutive weeks. Treatment was provided at bilateral acupoints Ex-LE-10 (Bafeng), Ex-LE-12 (Qiduan), and ST-34 (Lianqiu). Neurological assessments, including nerve conduction studies (NCS) of sural and tibial nerves, were performed at baseline and weeks 6 and 15. Primary outcome was delta of sural sensory nerve action potential (SNAP). Secondary outcomes included further NCS values, clinical scores, and patient-reported outcome measures (PROMs).
RESULTS
Of 180 participants, 172 completed the study. Sural SNAP and sural and tibial nerve conduction velocities improved significantly after 10 treatments when comparing needle acupuncture to placebo. Needle acupuncture showed earlier onset of action than laser acupuncture. PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture and for heat sensation following laser acupuncture.
CONCLUSIONS
Classical needle acupuncture had significant effects on DPN. Improvement in NCS values presumably indicates structural neuroregeneration following acupuncture.",2020,"PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture, and for heat sensation following laser acupuncture.
","['180 participants', 'diabetic peripheral neuropathy (DPN', 'Type 2 Diabetes', 'adults with confirmed type 2 diabetes-induced DPN to receive 10 sessions of']","['ACUpuncture', 'Acupuncture', 'Needle acupuncture', 'placebo', 'needle acupuncture, laser acupuncture, or placebo laser acupuncture', 'laser acupuncture']","['DPN', 'DIabetic Peripheral Neuropathy', 'Sural SNAP and sural and tibial nerve conduction velocities', 'NCS values, clinical scores, and patient-reported outcome measures (PROMs', 'Neurological assessments, including nerve conduction studies (NCS) of sural and tibial nerves', 'hyperesthesia and cramps', 'delta of sural sensory nerve action potential (SNAP']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181956', 'cui_str': 'Acupuncture needle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}]","[{'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0522219', 'cui_str': 'Sensory potential'}, {'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020453', 'cui_str': 'Hyperesthesia'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",180.0,0.745425,"PROMs showed larger improvements following needle and laser acupuncture than placebo, reaching significant differences for hyperesthesia and cramps following needle acupuncture, and for heat sensation following laser acupuncture.
","[{'ForeName': 'Gesa', 'Initials': 'G', 'LastName': 'Meyer-Hamme', 'Affiliation': 'HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Friedemann', 'Affiliation': 'HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Greten', 'Affiliation': 'Heidelberg School of Chinese Medicine, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gerloff', 'Affiliation': 'University Hospital Hamburg-Eppendorf, Department of Neurology, Martinistraße 52, Hamburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schroeder', 'Affiliation': 'HanseMerkur Center for Traditional Chinese Medicine at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of diabetes,['10.1111/1753-0407.13130']
1386,33160891,Predictive value of early cardiac magnetic resonance imaging functional and geometric indexes for adverse left ventricular remodelling in patients with anterior ST-segment elevation myocardial infarction: A report from the CIRCUS study.,"BACKGROUND
Postinfarction adverse left ventricular (LV) remodelling is strongly associated with heart failure events. Conicity index, sphericity index and LV global functional index (LVGFI) are new LV remodelling indexes assessed by cardiac magnetic resonance (CMR).
AIM
To assess the predictive value of the new indexes for 1-year adverse LV remodelling in patients with anterior ST-segment elevated myocardial infarction (STEMI).
METHODS
CMR studies were performed in 129 patients with anterior STEMI (58±12 years; 78% men) from the randomized CIRCUS trial (CMR substudy) treated with primary percutaneous coronary intervention and followed for the occurrence of major adverse cardiovascular events (MACE) (death or hospitalization for heart failure). Conicity index, sphericity index, LVGFI, infarct size and microvascular obstruction (MVO) were assessed by CMR performed 5±4 days after coronary reperfusion. Adverse LV remodelling was defined as an increase in LV end-diastolic volume of ≥15% by transthoracic echocardiography at 1 year.
RESULTS
Adverse LV remodelling occurred in 27% of patients at 1 year. Infarct size and MVO were significantly predictive of adverse LV remodelling: odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05 (P<0.001) and OR 1.12, 95% CI 1.05-1.22 (P<0.001), respectively. Among the newly tested indexes, only LVGFI was significantly predictive of adverse LV remodelling (OR 1.10, 95% CI 1.03-1.16; P=0.001). In multivariable analysis, infarct size remained an independent predictor of adverse LV remodelling at 1 year (OR 1.05, 95% CI 1.02-1.08; P<0.001). LVGFI and infarct size were associated with occurrence of MACE: OR 1.21, 95% CI 1.08-1.37 (P<0.001) and OR 1.02, 95% CI 1.00-1.04 (P=0.018), respectively. Conicity and sphericity indexes were not associated with MACE.
CONCLUSIONS
LVGFI was associated with adverse LV remodelling and MACE 1 year after anterior STEMI.",2020,"Infarct size and MVO were significantly predictive of adverse LV remodelling: odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05 (P<0.001) and OR 1.12, 95% CI 1.05-1.22 (P<0.001), respectively.","['129 patients with anterior STEMI (58±12 years; 78% men', 'patients with anterior ST-segment elevation myocardial infarction', 'patients with anterior ST-segment elevated myocardial infarction (STEMI']","['primary percutaneous coronary intervention', 'cardiac magnetic resonance imaging functional and geometric indexes']","['adverse cardiovascular events (MACE) (death or hospitalization for heart failure', 'Adverse LV remodelling', 'LVGFI and infarct size', 'LV end-diastolic volume', 'Infarct size and MVO', 'adverse LV remodelling', 'Conicity index, sphericity index, LVGFI, infarct size and microvascular obstruction (MVO', 'Conicity and sphericity indexes', 'Conicity index, sphericity index and LV global functional index (LVGFI']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3874460', 'cui_str': 'Anterior ST segment elevation'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0600519', 'cui_str': 'Ventricular remodelling'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]",129.0,0.369985,"Infarct size and MVO were significantly predictive of adverse LV remodelling: odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05 (P<0.001) and OR 1.12, 95% CI 1.05-1.22 (P<0.001), respectively.","[{'ForeName': 'Théo', 'Initials': 'T', 'LastName': 'Pezel', 'Affiliation': 'Inserm, UMRS 942, Department of Cardiology, Lariboisière Hospital, Paris University, AP-HP, 75010 Paris, France; Division of Cardiology, Johns-Hopkins University, 21287-0409 Baltimore, MD, USA.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Besseyre des Horts', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Schaaf', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Croisille', 'Affiliation': 'Radiology Department, University Hospital of Saint-Étienne, 42270 Saint-Priest-en-Jarez, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Bière', 'Affiliation': 'Cardiology Division, University Hospital of Angers, 49100 Angers, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Garcia-Dorado', 'Affiliation': ""CIBERCV, Hospital Universitari Vall d'Hebron & Research Institute, Universitat Autònoma de Barcelona, 08035 Barcelona, Spain.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jossan', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'UMR5203, UMR661, Cardiology Division, University Hospital of Montpellier, University of Montpellier 1 and 2, 34295 Montpellier, France.'}, {'ForeName': 'Thien-Tri', 'Initials': 'TT', 'LastName': 'Cung', 'Affiliation': 'UMR5203, UMR661, Cardiology Division, University Hospital of Montpellier, University of Montpellier 1 and 2, 34295 Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Prunier', 'Affiliation': 'Cardiology Division, University Hospital of Angers, 49100 Angers, France.'}, {'ForeName': 'Elbaz', 'Initials': 'E', 'LastName': 'Meyer', 'Affiliation': 'Rangeuil Hospital, University Hospital of Toulouse, Paul-Sabatier University, 31400 Toulouse, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Amaz', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Derumeaux', 'Affiliation': 'DHU-ATVB, Henri-Mondor Hospital, Paris-Est Créteil University, AP-HP, 94010 Créteil, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'de Poli', 'Affiliation': 'Cardiology Division, Haguenau Hospital, 67500 Haguenau, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hovasse', 'Affiliation': 'Cardiology Division, Jacques-Cartier Institute, 91300 Massy, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Gilard', 'Affiliation': 'Department of Cardiology, Brest University Hospital, 29200 Brest, France.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Bergerot', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Thibault', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ovize', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Mewton', 'Affiliation': 'Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France. Electronic address: nathan.mewton@chu-lyon.fr.'}]",Archives of cardiovascular diseases,['10.1016/j.acvd.2020.05.024']
1387,33166694,"Post-exposure prophylaxis with hydroxychloroquine for the prevention of COVID-19, a myth or a reality? The PEP-CQ Study.","Many drugs have been tried for the treatment/prevention of COVID-19 with limited success. Direct household contacts of COVID-19 patients are at highest risk for SARS-CoV-2 infection. Hydroxychloroquine (HCQ) has been tried against COVID-19 owing to its in vitro virucidal action against SARS-CoV-2, but the role of HCQ as post-exposure prophylaxis (PEP) remains inconclusive. In this open-label, controlled clinical trial, asymptomatic individuals who had direct contact with laboratory-confirmed COVID-19 cases or had undertaken international travel in the last 2 weeks were offered HCQ prophylaxis and assigned to PEP (n = 132) or control (n = 185) group. The PEP group received HCQ 800 mg on Day 1 followed by 400 mg once weekly for 3 weeks. Both groups undertook home quarantine for 2 weeks along with social distancing and personal hygiene. Over 4-week follow-up, 50/317 participants (15.8%) had new-onset COVID-19. The incidence of COVID-19 was significantly (P = 0.033) lower in the PEP (14/132; 10.6%) compared to the control (36/185; 19.5%) group (total absolute risk reduction, -8.9% points). The NNT to prevent the occurrence of 1 COVID-19 case was 12. Overall relative risk was 0.59 (95% CI 0.33-1.05). Compliance was good. The most common adverse event was epigastric discomfort with burning sensation (three participants), with no serious adverse events. PEP with HCQ has the potential for the prevention of COVID-19 in at-risk individuals. Until definitive therapy is available, continuing PEP with HCQ may be considered in suitable at-risk individuals. Further randomised clinical trials with larger samples are required for better evaluation of HCQ as PEP for COVID-19 prevention.",2020,"The incidence of COVID-19 was significantly (p=0.033) lower in PEP group [N=14 out of 132, (10.6%)] as compared to the control group [N=36 out of 185, (19.4%)].",['Total 50 out of 317 participants (15.8%) had new onset COVID-19'],"['Hydroxychloroquine (HCQ', 'tablet HCQ', 'PEP with HCQ']","['incidence of COVID-19', 'Total absolute risk reduction', 'overall relative risk', 'epigastric discomfort with burning sensation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191316', 'cui_str': '15.8'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0232570', 'cui_str': 'Epigastric fullness'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}]",317.0,0.0487297,"The incidence of COVID-19 was significantly (p=0.033) lower in PEP group [N=14 out of 132, (10.6%)] as compared to the control group [N=36 out of 185, (19.4%)].","[{'ForeName': 'Deba Prasad', 'Initials': 'DP', 'LastName': 'Dhibar', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India. Electronic address: drdeba_prasad@yahoo.co.in.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Arpit', 'Initials': 'A', 'LastName': 'Kakkar', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ritin', 'Initials': 'R', 'LastName': 'Mohindra', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Suri', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bhalla', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Navneet', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Internal Medicine, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mini P', 'Initials': 'MP', 'LastName': 'Singh', 'Affiliation': 'Department of Virology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Prakash', 'Affiliation': 'Department of Pharmacology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Pvm', 'Affiliation': 'Community Medicine and School of Public Health, PGIMER, Chandigarh, India.'}, {'ForeName': 'Bikash', 'Initials': 'B', 'LastName': 'Medhi', 'Affiliation': 'Department of Pharmacology, PGIMER, Chandigarh, India.'}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106224']
1388,33166718,Atezolizumab Versus Docetaxel in Pretreated Patients With NSCLC: Final Results From the Randomized Phase 2 POPLAR and Phase 3 OAK Clinical Trials.,"INTRODUCTION
The phase 2 POPLAR and phase 3 OAK studies of the anti-programmed death-ligand 1 (PD-L1) immunotherapy atezolizumab in patients with previously treated advanced NSCLC revealed significant improvements in survival versus docetaxel (p = 0.04 and 0.0003, respectively). Longer follow-up permits evaluation of continued benefit of atezolizumab. This study reports the final overall survival (OS) and safety findings from both trials.
METHODS
POPLAR randomized 287 patients (atezolizumab, 144; docetaxel, 143) and OAK randomized 1225 patients (atezolizumab, 613; docetaxel, 612). The patients received atezolizumab (1200 mg fixed dose) or docetaxel (75 mg/m 2 ) every 3 weeks. Efficacy and safety outcomes were evaluated.
RESULTS
A longer OS was observed in patients receiving atezolizumab versus docetaxel in POPLAR (median OS = 12.6 mo versus 9.7 mo; hazard ratio = 0.76, 95% confidence interval [CI]: 0.58-1.00) and OAK (median OS = 13.3 versus 9.8 mo; hazard ratio = 0.78, 95% CI: 0.68-0.89). The 4-year OS rates in POPLAR were 14.8% (8.7-20.8) and 8.1% (3.2-13.0) and those in OAK were 15.5% (12.4-18.7) and 8.7% (6.2-11.3) for atezolizumab and docetaxel, respectively. Atezolizumab had improved OS benefit compared with docetaxel across all PD-L1 expression and histology groups. Most 4-year survivors in the docetaxel arms received subsequent immunotherapy (POPLAR, 50%; OAK, 65%). Of the 4-year survivors, most had Eastern Cooperative Oncology Group performance status of 0 and nonsquamous histological classification and approximately half were responders (POPLAR: atezolizumab, seven of 15; docetaxel, three of four; OAK: atezolizumab, 24 of 43; docetaxel, 11 of 26). Treatment-related grade 3/4 adverse events occurred in 27% and 16% of atezolizumab 4-year survivors in POPLAR and OAK, respectively.
CONCLUSIONS
Long-term follow-up suggests a consistent survival benefit with atezolizumab versus docetaxel in patients with previously treated NSCLC regardless of PD-L1 expression, histology, or subsequent immunotherapy. Atezolizumab had no new safety signals, and the safety profile was similar to that in previous studies.",2020,A longer OS was observed in patients receiving atezolizumab vs docetaxel in POPLAR (median OS: 12.6 months vs 9.7 months; HR: 0.76,"['patients with previously treated NSCLC regardless of PD-L1 expression, histology, or subsequent immunotherapy', 'POPLAR randomized 287 (atezolizumab,144; docetaxel,143) and OAK randomized 1225 (atezolizumab, 613; docetaxel, 612) patients', 'patients with previously treated advanced non-small cell lung cancer', 'Pretreated Patients with Non-Small Cell Lung Cancer']","['Atezolizumab', 'Atezolizumab vs Docetaxel', 'atezolizumab vs docetaxel', 'atezolizumab', 'docetaxel', 'anti-PD-L1 immunotherapy atezolizumab']","['Grade 3/4 adverse events', 'survival vs docetaxel', 'Efficacy and safety outcomes', 'OS benefit', 'ECOG PS 0 and nonsquamous histology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0522458', 'cui_str': 'Populus'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0019638', 'cui_str': 'Histology'}]",1225.0,0.0742898,A longer OS was observed in patients receiving atezolizumab vs docetaxel in POPLAR (median OS: 12.6 months vs 9.7 months; HR: 0.76,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse, Toulouse University Hospital, Université Paul Sabatier, Toulouse, France. Electronic address: mazieres.j@chu-toulouse.fr.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Rittmeyer', 'Affiliation': 'Department of Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen, Germany.'}, {'ForeName': 'Shirish', 'Initials': 'S', 'LastName': 'Gadgeel', 'Affiliation': 'Henry Ford Cancer Institute, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Hida', 'Affiliation': 'Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'Department of Internal Medicine, UC Davis Comprehensive Cancer Center, Sacramento, California.'}, {'ForeName': 'Diego L', 'Initials': 'DL', 'LastName': 'Cortinovis', 'Affiliation': 'SC Oncologia Medica, SS Lung Unit Asst Ospedale San Gerardo, Monza, Italy.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'CNRS, INSERM, CRCM, APHM, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'US Medical Affairs, Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Matheny', 'Affiliation': 'Product Development, Oncology, Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ballinger', 'Affiliation': 'Product Development, Oncology, Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.09.022']
1389,33170378,Effect of L-Carnosine as adjunctive therapy in the management of children with autism spectrum disorder: a randomized controlled study.,"L-Carnosine is an amino acid that acts as an anti-oxidant, anti-toxic and neuroprotective agent. There is a paucity of data about the effectiveness of L-Carnosine in the management of autism spectrum disorder (ASD) in children. This study aimed at investigating the effectiveness of L-Carnosine as adjunctive therapy in the management of ASD. This was a randomized controlled trial. Children aged 3-6 years with a diagnosis of mild to moderate ASD were assigned to standard care arm (occupational and speech therapy) and intervention care arm (L-Carnosine, 10-15 mg/kg in 2 divided doses) plus standard care treatment. The children were assessed at the baseline and the end of 2 months for the scores of Childhood Autism Rating Scale, Second Edition-Standard Version (CARS2-ST), Autism Treatment Evaluation Checklist (ATEC), BEARS sleep screening tool and 6-item Gastrointestinal Severity Index (6-GSI). Of the sixty-seven children enrolled, sixty-three children had completed the study. No statistically significant difference (p > 0.05) was observed for any of the outcome measures assessed. Supplementation of L-Carnosine did not improve the total score of CARS2-ST, ATEC, BEARS sleep screening tool and 6-GSI scores of children with ASD. Further investigations are needed with more objective assessments to critically validate the effectiveness of L-Carnosine on ASD children for more decisive results.",2020,"Supplementation of L-Carnosine did not improve the total score of CARS2-ST, ATEC, BEARS sleep screening tool and 6-GSI scores of children with ASD.","['sixty-seven children enrolled, sixty-three children had completed the study', 'children with autism spectrum disorder', 'autism spectrum disorder (ASD) in children', 'children with ASD', 'Children aged 3-6\xa0years with a diagnosis of mild to moderate ASD']","['standard care arm (occupational and speech therapy) and intervention care arm (L-Carnosine, 10-15\xa0mg/kg in 2 divided doses) plus standard care treatment', 'L-Carnosine']","['total score of CARS2-ST, ATEC, BEARS sleep screening tool and 6-GSI scores', 'scores of Childhood Autism Rating Scale, Second Edition-Standard Version (CARS2-ST), Autism Treatment Evaluation Checklist (ATEC), BEARS sleep screening tool and 6-item Gastrointestinal Severity Index (6-GSI']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0557980', 'cui_str': 'Evaluating interventions'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",67.0,0.0559366,"Supplementation of L-Carnosine did not improve the total score of CARS2-ST, ATEC, BEARS sleep screening tool and 6-GSI scores of children with ASD.","[{'ForeName': 'Debi', 'Initials': 'D', 'LastName': 'Ann Abraham', 'Affiliation': 'Department of Pharmacy Practice, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, 600 116, India.'}, {'ForeName': 'Udayakumar', 'Initials': 'U', 'LastName': 'Narasimhan', 'Affiliation': 'Department of Paediatric Medicine, Sri Ramachandra Medical College and Research Institute, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Senta', 'Initials': 'S', 'LastName': 'Christy', 'Affiliation': 'Karthikeyan Child Development Unit, Sri Ramachandra Medical Centre, Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Rajanandh', 'Initials': 'R', 'LastName': 'Muhasaparur Ganesan', 'Affiliation': 'Department of Pharmacy Practice, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, Tamil Nadu, 600 116, India. rajanandh.mg@sriramachandra.edu.in.'}]",Amino acids,['10.1007/s00726-020-02909-1']
1390,33175291,Tiotropium/Olodaterol Delays Clinically Important Deterioration Compared with Tiotropium Monotherapy in Patients with Early COPD: a Post Hoc Analysis of the TONADO ® Trials.,"INTRODUCTION
Since chronic obstructive pulmonary disease (COPD) is a heterogeneous condition, a composite endpoint of clinically important deterioration (CID) may provide a more holistic assessment of treatment efficacy. We compared long-acting muscarinic antagonist/long-acting β 2 -agonist combination therapy with tiotropium/olodaterol versus tiotropium alone using a composite endpoint for CID. CID was evaluated overall and in patients with low exacerbation history (at most one moderate exacerbation in the past year [not leading to hospitalisation]), Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2 patients and maintenance-naïve patients with COPD. We assessed whether early treatment optimisation is more effective with tiotropium/olodaterol versus tiotropium in delaying and reducing the risk of CID.
METHODS
Data were analysed from 2055 patients treated with either tiotropium/olodaterol 5/5 μg or tiotropium 5 μg (delivered via Respimat ® ) in two replicate, 52-week, parallel-group, double-blind studies (TONADO ® 1/2). CID was defined as a decline of at least 0.1 L from baseline in trough forced expiratory volume in 1 s, increase from baseline of at least 4 units in St. George's Respiratory Questionnaire score, or moderate/severe exacerbation. Time to first occurrence of one of these events was recorded as time to first CID.
RESULTS
Overall, treatment with tiotropium/olodaterol significantly increased the time to, and reduced the risk of, CID versus tiotropium (median time to CID 226 versus 169 days; hazard ratio [HR] 0.76 [95% confidence interval 0.68, 0.85]; P < 0.0001). Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030).
CONCLUSION
In patients with COPD, including patients with low exacerbation history, GOLD 2 patients and maintenance-naïve patients, tiotropium/olodaterol reduced the risk of CID versus tiotropium. These results demonstrate the advantages of treatment optimisation with tiotropium/olodaterol over tiotropium monotherapy.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: TONADO ® 1 and 2 (NCT01431274 and NCT01431287, registered 8 September 2011).",2020,"Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030).
","['Data were analysed from 2055 patients treated with either', 'Patients with Early COPD']","['Tiotropium Monotherapy', 'tiotropium/olodaterol', 'tiotropium/olodaterol 5/5\xa0μg or tiotropium 5\xa0μg (delivered via Respimat ® ', 'tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium/Olodaterol']","['risk of, CID', 'CID', 'Respiratory Questionnaire score, or moderate/severe exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",2.0,0.379732,"Significant reductions were also observed in patients with low exacerbation history (241 versus 170; HR 0.73 [0.64, 0.83]; P < 0.0001), GOLD 2 patients (241 versus 169; 0.72 [0.61, 0.84]; P < 0.0001) and maintenance-naïve patients (233 versus 171; 0.75 [0.62, 0.91]; P = 0.0030).
","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany. k.f.rabe@lungenclinic.de.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Tayside Respiratory Research Group, University of Dundee, Dundee, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Miravitlles', 'Affiliation': ""Pneumology Department, Hospital Universitari Vall d'Hebron, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.""}, {'ForeName': 'Janwillem W H', 'Initials': 'JWH', 'LastName': 'Kocks', 'Affiliation': 'General Practitioners Research Institute, Groningen, The Netherlands.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Tsiligianni', 'Affiliation': 'Health Planning Unit, Department of Social Medicine, Faculty of Medicine, University of Crete, Crete, Greece.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit (MEU), University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.'}, {'ForeName': 'Jadwiga', 'Initials': 'J', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK.'}]",Advances in therapy,['10.1007/s12325-020-01528-2']
1391,33171589,"The Effect of Supplementation with Low Doses of a Cod Protein Hydrolysate on Satiety Hormones and Inflammatory Biomarkers in Adults with Metabolic Syndrome: A Randomized, Double-Blind Study.","Metabolic syndrome (MetS) is characterised by metabolic abnormalities that increase the risk of developing type 2 diabetes mellitus and cardiovascular disease. Altered levels of circulating ghrelin, several adipokines and inflammatory markers secreted from adipose tissue, such as leptin, adiponectin, tumor necrosis factor alpha, are observed in overweight and obese individuals. We assessed the effect of supplementation with low doses of a cod protein hydrolysate (CPH) on fasting and postprandial levels of acylated ghrelin, as well as fasting levels of adiponectin, leptin and inflammatory markers in subjects with MetS. A multicentre, double-blinded, randomized controlled trial with a parallel group design was conducted. Subjects received a daily supplement of CPH (4 g protein, n = 15) or placebo (0 g protein, n = 15). We observed no effect on fasting or postprandial levels of acylated ghrelin, fasting levels of adiponectin ( p = 0.089) or leptin ( p = 0.967) after supplementation with CPH, compared to placebo. Overall, our study showed that 8 weeks supplementation with a low dose of CPH in subjects with MetS had no effect on satiety hormones or most of the inflammatory markers, but the levels of high-sensitivity C-reactive protein were statistically significantly different in the CPH-group compared to placebo group. The robustness and clinical relevance of these findings should be explored in future studies with a larger sample size.",2020,"We observed no effect on fasting or postprandial levels of acylated ghrelin, fasting levels of adiponectin ( p = 0.089) or leptin ( p = 0.967) after supplementation with CPH, compared to placebo.","['Adults with Metabolic Syndrome', 'subjects with MetS. A multicentre']","['CPH', 'Cod Protein Hydrolysate', 'placebo', 'daily supplement of CPH', 'cod protein hydrolysate (CPH']","['fasting levels of adiponectin, leptin and inflammatory markers', 'levels of high-sensitivity C-reactive protein', 'fasting or postprandial levels of acylated ghrelin, fasting levels of adiponectin', 'Satiety Hormones and Inflammatory Biomarkers', 'satiety hormones']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0033631', 'cui_str': 'protein hydrolysates'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",,0.525344,"We observed no effect on fasting or postprandial levels of acylated ghrelin, fasting levels of adiponectin ( p = 0.089) or leptin ( p = 0.967) after supplementation with CPH, compared to placebo.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Hanna Fjeldheim', 'Initials': 'HF', 'LastName': 'Dale', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Hausken', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Jan Gunnar', 'Initials': 'JG', 'LastName': 'Hatlebakk', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Brønstad', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Haukeland University Hospital, 5021 Bergen, Norway.'}, {'ForeName': 'Gülen Arslan', 'Initials': 'GA', 'LastName': 'Lied', 'Affiliation': 'Centre for Nutrition, Department of Clinical Medicine, University of Bergen, 5021 Bergen, Norway.'}, {'ForeName': 'Dag Arne Lihaug', 'Initials': 'DAL', 'LastName': 'Hoff', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Ålesund Hospital, Møre and Romsdal Hospital Trust, 6026 Ålesund, Norway.'}]",Nutrients,['10.3390/nu12113421']
1392,33128912,"Tranexamic acid in patients with intracerebral haemorrhage (STOP-AUST): a multicentre, randomised, placebo-controlled, phase 2 trial.","BACKGROUND
Despite intracerebral haemorrhage causing 5% of deaths worldwide, few evidence-based therapeutic strategies other than stroke unit care exist. Tranexamic acid decreases haemorrhage in conditions such as acute trauma and menorrhoea. We aimed to assess whether tranexamic acid reduces intracerebral haemorrhage growth in patients with acute intracerebral haemorrhage.
METHODS
We did a prospective, double-blind, randomised, placebo-controlled, investigator-led, phase 2 trial at 13 stroke centres in Australia, Finland, and Taiwan. Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography. Patients were randomly assigned (1:1) to receive either 1 g of intravenous tranexamic acid over 10 min followed by 1 g over 8 h or matching placebo, started within 4·5 h of symptom onset. Randomisation was done using a centralised web-based procedure with randomly permuted blocks of varying size. All patients, investigators, and staff involved in patient management were masked to treatment. The primary outcome was intracerebral haemorrhage growth (>33% relative or >6 mL absolute) at 24 h. The primary and safety analyses were done in the intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT01702636).
FINDINGS
Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the tranexamic acid group (n=50) or the placebo group (n=50). Median age was 71 years (IQR 57-79) and median intracerebral haemorrhage volume was 14·6 mL (7·9-32·7) at baseline. The primary outcome was not different between the two groups: 26 (52%) patients in the placebo group and 22 (44%) in the tranexamic acid group had intracerebral haemorrhage growth (odds ratio [OR] 0·72 [95% CI 0·32-1·59], p=0·41). There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications. None of the deaths was considered related to study medication.
INTERPRETATION
Our study does not provide evidence that tranexamic acid prevents intracerebral haemorrhage growth, although the treatment was safe with no increase in thromboembolic complications. Larger trials of tranexamic acid, with simpler recruitment methods and an earlier treatment window, are justified.
FUNDING
National Health and Medical Research Council, Royal Melbourne Hospital Foundation.",2020,There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications.,"['Patients were eligible if they were aged 18 years or older, had an acute intracerebral haemorrhage fulfilling clinical criteria (eg, Glasgow Coma Scale score of >7, intracerebral haemorrhage volume <70 mL, no identified or suspected secondary cause of intracerebral haemorrhage, no thrombotic events within the previous 12 months, no planned surgery in the next 24 h, and no use of anticoagulation), had contrast extravasation on CT angiography (the so-called spot sign), and were treatable within 4·5 h of symptom onset and within 1 h of CT angiography', 'patients with acute intracerebral haemorrhage', 'Between March 1, 2013, and Aug 13, 2019, we enrolled and randomly assigned 100 participants to the', '13 stroke centres in Australia, Finland, and Taiwan', 'patients with intracerebral haemorrhage (STOP-AUST']","['intravenous tranexamic acid', 'placebo', 'tranexamic acid', 'Tranexamic acid']","['median intracerebral haemorrhage volume', 'thromboembolic complications', 'intracerebral haemorrhage growth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449867', 'cui_str': 'Use of anticoagulation'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0450446', 'cui_str': 'Stops'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",100.0,0.776123,There was no evidence of a difference in the proportions of patients who died or had thromboembolic complications between the groups: eight (16%) in the placebo group vs 13 (26%) in the tranexamic acid group died and two (4%) vs one (2%) had thromboembolic complications.,"[{'ForeName': 'Atte', 'Initials': 'A', 'LastName': 'Meretoja', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Neurology, Helsinki University Hospital, Helsinki, Finland. Electronic address: atte.meretoja@hus.fi.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Population Health and Immunity Division, The Walter and Eliza Hall Institute of Medical Research, Melbourne, VIC, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; New Zealand Brain Research Institute, Christchurch, New Zealand.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; Department of Mathematics and Statistics, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Gerli', 'Initials': 'G', 'LastName': 'Sibolt', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jiann-Shing', 'Initials': 'JS', 'LastName': 'Jeng', 'Affiliation': 'Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Spratt', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Department of Neurology, Austin Hospital, Heidelberg, VIC, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Department of Neurology, Western Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Der-Yang', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Department of Neurosurgery, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Woolloongabba, QLD, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Monash University, Melbourne, VIC, Australia; Department of Clinical Neuroscience, Central Clinical School, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Thanh', 'Initials': 'T', 'LastName': 'Phan', 'Affiliation': 'Department of Neurology, Monash Medical Centre, Monash University, Melbourne, VIC, Australia; School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Department of Neurosciences, Eastern Health Medical School, Monash University, Melbourne, VIC, Australia; Ambulance Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moey', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Aviv', 'Affiliation': 'Department of Radiology, Neuroradiology Section, The Ottawa Hospital and University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Christen D', 'Initials': 'CD', 'LastName': 'Barras', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia; South Australian Health and Medical Research Institute, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Chung Y', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Monash Medical Centre, Monash University, Melbourne, VIC, Australia; School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Marjaana', 'Initials': 'M', 'LastName': 'Tiainen', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Curtze', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Strbian', 'Affiliation': 'Department of Neurology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sung-Chun', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, NSW, Australia; Sydney Partnership for Health, Education, Research and Enterprise (SPHERE), Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia; Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Departments of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30369-0']
1393,33128939,Rare Functional Variants Associated with Antidepressant Remission in Mexican-Americans: Short title: Antidepressant remission and pharmacogenetics in Mexican-Americans.,"INTRODUCTION
Rare genetic functional variants can contribute to 30-40% of functional variability in genes relevant to drug action. Therefore, we investigated the role of rare functional variants in antidepressant response.
METHOD
Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD) participated in a prospective randomized, double-blind study with desipramine or fluoxetine. The rare variant analysis was performed using whole-exome genotyping data. Network and pathway analyses were carried out with the list of significant genes.
RESULTS
The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01). Pathway analysis of these genes supports the involvement of the following gene ontology processes: olfactory/sensory transduction, regulation of response to cytokine stimulus, and meiotic cell cycleprocess.
LIMITATIONS
Our study did not have a placebo arm. We were not able to use antidepressant blood level as a covariate. Our study is based on a small sample size of only 65 Mexican-American individuals. Further studies using larger cohorts are warranted.
CONCLUSION
Our data identified several rare functional variants in antidepressant drug response in MDD patients. These have the potential to serve as genetic markers for predicting drug response.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00265291.",2020,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","['Mexican-American individuals meeting the Diagnostic and Statistical Manual-IV criteria for major depressive disorder (MDD', '65 Mexican-American individuals', 'MDD patients', 'Mexican-Americans']",['desipramine or fluoxetine'],['Antidepressant remission and pharmacogenetics'],"[{'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}]",,0.0426557,"The Kernel-Based Adaptive Cluster method identified functional rare variants in 35 genes significantly associated with treatment remission (False discovery rate, FDR <0.01).","[{'ForeName': 'Ma-Li', 'Initials': 'ML', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: wongma@upstate.edu.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arcos-Burgos', 'Affiliation': 'Grupo de Investigación en Psiquiatría, Departamento de Psiquiatría, Instituto de Investigaciones Médicas, Facultad de Medicina, Universidad de Antioquia, Medellin, Antioquia, Colombia.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Alice W', 'Initials': 'AW', 'LastName': 'Licinio', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia.'}, {'ForeName': 'Eunice W M', 'Initials': 'EWM', 'LastName': 'Chin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Yao', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Xin-Yun', 'Initials': 'XY', 'LastName': 'Lu', 'Affiliation': 'Department of Neuroscience & Regenerative Medicine, Medical College of Georgia at Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Stefan R', 'Initials': 'SR', 'LastName': 'Bornstein', 'Affiliation': 'Medical Clinic III, Carl Gustav Carus University Hospital, Dresden University of Technology, Dresden, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Licinio', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, State University of New York, Upstate Medical University, Syracuse, NY, USA; Department of Neuroscience and Physiology, State University of New York, Upstate Medical University, Syracuse, NY, USA; Mind & Brain Theme, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia; Department of Psychiatry, Flinders University College of Medicine and Public Health, Bedford Park, South Australia, Australia. Electronic address: licinioJ@upstate.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.027']
1394,33129015,Hormonal treatment isolated versus hormonal treatment associated with electrotherapy for pelvic pain control in deep endometriosis: Randomized clinical trial.,"OBJECTIVE
The aim of the study was to evaluate the clinical effectiveness of complementary treatment using self-applied electrotherapy treatment for pain control over the standard hormonal treatment alone for deep infiltrative endometriosis (DIE).
STUDY DESIGN
Multicentre randomized clinical trial. We included a hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up. The primary measurement was chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia. The secondary outcomes were the quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI).
RESULTS
CPP relief was observed only in the electrotherapy group (pre:7.11 ± 2.40, post:4.55 ± 3.08, p < 0.001). In terms of deep dyspareunia, improvements were observed for both groups (electrotherapy pre:2.02 ± 0.54-1.36 ± 0.96, p < 0.001; control pre:1.95 ± 0.86-1.68 ± 0.82, p = 0.006). Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups. Regarding sexual function, there was a statistically significant improvement in the FSFI score for the electrotherapy group (p < 0.001), with an increase in the scores for lubrication and pain domains (p = 0.013 and p < 0.001).
CONCLUSIONS
Electrotherapy treatment using transcutaneous electrical nerve stimulation proved to be a good complementary option for pain control, showing benefits in the reduction of CPP and deep dyspareunia and improving patient's quality of life and sexual function.",2020,"Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups.","['deep endometriosis', 'deep infiltrative endometriosis (DIE', 'hundred-one participants with DIE in electrotherapy (n = 53) (hormonal treatment + electrotherapy) or control group (n = 48) (only hormonal treatment) by 8 weeks of follow-up']","['electrotherapy', 'self-applied electrotherapy treatment']","['CPP relief', 'higher total score post-treatment for the EHP-30', 'quality of life by endometriosis health profile (EHP-30) and sexual function by female sexual function index (FSFI', 'scores for lubrication and pain domains', 'deep dyspareunia', 'chronic pelvic pain (CPP) using a visual analogue scale (VAS) and deep dyspareunia', 'FSFI score']","[{'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0423747', 'cui_str': 'Deep pain on intercourse'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1.0,0.0619372,"Considering the secondary outcomes, a higher total score post-treatment for the EHP-30 was noted in both groups.","[{'ForeName': 'Ticiana A A', 'Initials': 'TAA', 'LastName': 'Mira', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: ticiana.mira@gmail.com.'}, {'ForeName': 'Daniela A', 'Initials': 'DA', 'LastName': 'Yela', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: yeladaniela12@gmail.com.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Podgaec', 'Affiliation': 'Medical School, Department of Obstetrics and Gynecology, University of São Paulo, Av. Dr. Enéas Carvalho de Aguiar, 255 - Cerqueira César, São Paulo, SP, 05403-000, Brazil. Electronic address: sergiopodgaec@me.com.'}, {'ForeName': 'Edmund C', 'Initials': 'EC', 'LastName': 'Baracat', 'Affiliation': 'Medical School, Department of Obstetrics and Gynecology, University of São Paulo, Av. Dr. Enéas Carvalho de Aguiar, 255 - Cerqueira César, São Paulo, SP, 05403-000, Brazil. Electronic address: ecbaracat@gmail.com.'}, {'ForeName': 'Cristina L', 'Initials': 'CL', 'LastName': 'Benetti-Pinto', 'Affiliation': 'School of Medical Sciences, Department of Obstetrics and Gynecology, University of Campinas, Alexander Fleming, 101, Cidade Universitária, Campinas, SP, 13083-881, Brazil. Electronic address: laguna.unicamp@gmail.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.018']
1395,33129099,"Nano-curcumin therapy, a promising method in modulating inflammatory cytokines in COVID-19 patients.","BACKGROUND
As an ongoing worldwide health issue, Coronavirus disease 2019 (COVID-19) has been causing serious complications, including pneumonia, acute respiratory distress syndrome (ARDS), and multi-organ failure. However, there is no decisive treatment approach available for this disorder, which is primarily attributed to the large amount of inflammatory cytokine production. We aimed to identify the effects of Nano-curcumin on the modulation of inflammatory cytokines in COVID-19 patients.
METHOD
Forty COVID-19 patients and 40 healthy controls were recruited and evaluated for inflammatory cytokine expression and secretion. Subsequently, COVID-19 patients were divided into two groups: 20 patients receiving Nano-curcumin and 20 patients as the placebo group. The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
RESULT
Our primary results indicated that the mRNA expression and cytokine secretion of IL-1β, IL-6, TNF-α, and IL-18 were increased significantly in COVID-19 patients compared with healthy control group. After treatment with Nano-curcumin, a significant decrease in IL-6 expression and secretion in serum and in supernatant (P = 0.0003, 0.0038, and 0.0001, respectively) and IL-1β gene expression and secretion level in serum and supernatant (P = 0.0017, 0.0082, and 0.0041, respectively) was observed. However, IL-18 mRNA expression and TNF-α concentration were not influenced by Nano-curcumin.
CONCLUSION
Nano-curcumin, as an anti-inflammatory herbal based agent, may be able to modulate the increased rate of inflammatory cytokines especially IL-1β and IL-6 mRNA expression and cytokine secretion in COVID-19 patients, which may cause an improvement in clinical manifestation and overall recovery.",2020,"The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
","['Forty COVID-19 patients and 40 healthy controls', 'COVID-19 patients']","['placebo', 'Nano-curcumin']","['IL-6 expression and secretion in serum and in supernatant', 'mRNA expression and cytokine secretion of IL-1β, IL-6, TNF-α, and IL-18', 'inflammatory cytokine expression and secretion', 'IL-18 mRNA expression and TNF-α concentration', 'mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18', 'IL-1β gene expression and secretion level in serum and supernatant']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}]",40.0,0.0296856,"The mRNA expression and cytokine secretion levels of IL-1β, IL-6, TNF-α and IL-18 were assessed by Real-time PCR and ELISA, respectively.
","[{'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Valizadeh', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran; Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Abdolmohammadi-Vahid', 'Affiliation': ""Student's Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran; Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Danshina', 'Affiliation': 'Department of propaedeutics of dental diseases, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Ziya Gencer', 'Affiliation': 'Department of Family Medicine, Yassawi International Kazakh-Turkish University Hospital, Turkistan, Kazakhstan.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ammari', 'Affiliation': 'Department of Surgery, Mousavi Hospital, School of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Tuberculosis and Lung Disease Research Center of Tabriz University of Medical Sciences, Tabriz, Iran; Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Roshangar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Aslani', 'Affiliation': 'Department of Immunology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Cancer Gene Therapy Research Center (CGRC), Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Ghaebi', 'Affiliation': 'Cancer Gene Therapy Research Center (CGRC), Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Valizadeh', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: ahmadi.m@tbzmed.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.107088']
1396,33129156,Worry impairs the problem-solving process: Results from an experimental study.,"INTRODUCTION
Many individuals believe that worry helps solve real-life problems. Some researchers also purport that nonpathological worry can aid problem solving. However, this is in contrast to evidence that worry impairs cognitive functioning.
OBJECTIVE
This was the first study to empirically test the effects of a laboratory-based worry induction on problem-solving abilities.
PROCEDURE
Both high (n = 96) and low (n = 89) trait worriers described a current problem in their lives. They were then randomly assigned to contemplate their problem in a worrisome (n = 60) or objective (n = 63) manner or to engage in a diaphragmatic breathing task (n = 62). All participants subsequently generated solutions and then selected their most effective solution. Next, they rated their confidence in the solution's effectiveness, their likelihood to implement the solution, and their current anxiety/worry. Experimenters uninformed of condition also rated solution effectiveness.
RESULTS
The worry induction led to lower reported confidence in solutions for high trait worry participants, and lower experimenter-rated effectiveness of solutions for all participants, relative to objective thinking. Further, state worry predicted less reported intention to implement solutions, while controlling for trait worry. Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
CONCLUSIONS
Overall, the worry induction impaired problem solving on multiple levels, and this was true for both high and low trait worriers.",2020,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
",[],"['worrisome (n\xa0=\xa060) or objective (n\xa0=\xa063) manner or to engage in a diaphragmatic breathing task', 'laboratory-based worry induction']",['elevated worry and anxiety'],[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0231898', 'cui_str': 'Diaphragmatic breathing'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",96.0,0.0612885,"Finally, worrying about the problem led to more elevated worry and anxiety after solving the problem compared to the other two conditions.
","[{'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Llera', 'Affiliation': 'Department of Psychology, Towson University, 8000 York Road, Towson, MD, 21252, USA. Electronic address: sllera@towson.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, The Pennsylvania State University, 140 Moore Building, University Park, PA, 16801, USA. Electronic address: mgn1@psu.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103759']
1397,33130414,Effects of the school environment on early sexual risk behavior: A longitudinal analysis of students in English secondary schools.,"INTRODUCTION
The theory of human functioning and school organization proposes that schools promote health by strengthening students' educational engagement. Previous studies have relied on proxy measures of engagement and not examined sexual health. This paper addresses these gaps.
METHODS
Longitudinal data came from the control arm of a randomized trial involving female and male students ages 12-14 in English secondary-schools (n = 3337 students). Exposures measured at baseline included a proxy measure of school-level engagement (value-added education, VAE: the difference between observed absence and attainment rates and those predicted based on student characteristics) and direct measures of school- and student-level engagement (commitment, belonging, relationships and participation). Sexual behavior was measured at 24- and 36-months, including sexual debut and contraception use at first sex.
RESULTS
Higher school-level VAE was associated with an increased risk of early sexual debut at 24-months. Students attending schools with higher overall levels of commitment and belonging were less likely to report sexual debut at 36 months. Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points. Associations involving participation and contraception use were largely nonsignificant.
CONCLUSIONS
Direct measures of the school environment are more strongly associated with reduced sexual risk behavior in early adolescence than the proxy measure, VAE. Results provide some support for the theory and suggest that personal disposition towards school as well as attending a school with high levels of student commitment and belonging are important for subsequent sexual decision making.",2020,Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points.,"['students in English secondary schools', 'Students attending schools with higher overall levels of commitment and belonging were less likely to report sexual debut at 36 months', 'Longitudinal data came from the control arm of a randomized trial involving female and male students ages 12-14 in English secondary-schools (n\xa0=\xa03337 students']",['school environment'],"['proxy measure of school-level engagement (value-added education, VAE: the difference between observed absence and attainment rates and those predicted based on student characteristics) and direct measures of school- and student-level engagement (commitment, belonging, relationships and participation', 'Sexual behavior', 'sexual risk behavior', 'early sexual risk behavior']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0557295', 'cui_str': 'School attendance - finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",3337.0,0.0245885,Students reporting stronger personal commitment to learning and teacher relationships at baseline were less likely to report sexual debut at both follow-up points.,"[{'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Peterson', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: amy.peterson@etr.org.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1H 9SH, UK. Electronic address: elizabeth.allen@lshtm.ac.uk.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Viner', 'Affiliation': 'UCL Great Ormand Street Institute of Child Health, 30 Guilford Street, London WC1N 1EH, UK. Electronic address: r.viner@ucl.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bonell', 'Affiliation': 'Department of Public Health, Environments and Society, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: chris.bonell@lshtm.ac.uk.'}]",Journal of adolescence,['10.1016/j.adolescence.2020.10.004']
1398,33130477,"A 12-month, dose-level blinded safety and efficacy study of levodopa inhalation powder (CVT-301, Inbrija) in patients with Parkinson's disease.","INTRODUCTION
CVT-301 (Inbrija®) is a levodopa inhalation powder for on-demand treatment of OFF episodes in Parkinson's disease patients treated with carbidopa/levodopa. Safety and efficacy results of a 12-month, dose-level blinded extension study of a phase 3 trial (SPAN℠-PD) of CVT-301 are presented.
METHODS
Patients were receiving oral carbidopa/levodopa and adjunctive CVT-301 treatment, blinded to dose (60 mg or 84 mg, N = 325). Study visits occurred every 3 months. Pulmonary function was assessed by spirometry. Other safety assessments included dyskinesia and adverse events (AEs). Secondary objectives of the study included maintenance of improvement assessments for occurrence of an ON state during the 60-min post-dose period, change in total daily OFF time, and Patient Global Impression of Change (PGIC).
RESULTS
Most frequent AEs (≥5%) were cough (15.4%), fall (13.1%), upper respiratory tract infection (7.1%), and dyskinesia (5.1%). Severe AEs (>1 event) were cough (1.9%) and dyskinesia (0.6%). Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO were -0.092 L, -0.097 L, and -0.922 mL/min/mmHg, respectively. At 12 months, 73.0% of patients on 84 mg achieved an ON state within 60 min. Total daily OFF time was reduced by 0.55 h (month 1) and 0.88 h (month 12) for the 84 mg dose. Percentage of patients self-reported as improved by PGIC was 65.5-91.9% over 12 months.
CONCLUSION
CVT-301 was generally well-tolerated. Twelve-month decline in pulmonary function was consistent with a prior PD control group. Exploratory efficacy results showed CVT-301 maintained improvement at achieving ON states in patients experiencing OFF episodes, decreasing daily OFF time, and maintaining improvement in PGIC.",2020,"Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO were -0.092 ","[""Parkinson's disease patients treated with"", 'Patients were receiving', ""patients with Parkinson's disease""]","['levodopa inhalation powder (CVT-301, Inbrija', 'carbidopa/levodopa', 'oral carbidopa/levodopa and adjunctive CVT-301 treatment', 'CVT-301 (Inbrija™']","['dyskinesia and adverse events (AEs', 'upper respiratory tract infection', 'daily OFF time, and maintaining improvement in PGIC', 'cough', 'PGIC', 'Safety and efficacy', 'pulmonary function', 'FEV 1 , FVC, and DL CO', 'Total daily OFF time', 'tolerated', 'total daily OFF time, and Patient Global Impression of Change (PGIC', 'Pulmonary function', 'dyskinesia']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4745728', 'cui_str': 'Levodopa Inhalation Powder'}, {'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C4745523', 'cui_str': 'Inbrija'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0315546,"Twelve-month mean changes from baseline for FEV 1 , FVC, and DL CO were -0.092 ","[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Farbman', 'Affiliation': 'Roseman University of Health Sciences, Las Vegas, NV, USA. Electronic address: efarbman@roseman.edu.'}, {'ForeName': 'Cheryl H', 'Initials': 'CH', 'LastName': 'Waters', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'LeWitt', 'Affiliation': 'Department of Neurology, Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, MI, USA.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Rudzińska', 'Affiliation': 'Department of Neurology, Faculty of Medicine and Health Sciences, Andrzej Frycz Modrzewski Krakow University, Krakow, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Klingler', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Acorda Therapeutics, Inc., Ardsley, NY, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, FL, USA.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.10.029']
1399,33137422,Therapeutic Ultrasound for Chemotherapy-Related Pain and Sensory Disturbance in the Hands and Feet in Patients With Colorectal Cancer: A Pilot Randomized Controlled Trial.,"CONTEXT
This proof-of-concept trial was undertaken as a first step in exploring the clinical benefit of therapeutic ultrasound for pain and sensory disturbance in patients with colorectal cancer.
OBJECTIVES
The aim of this study was to determine the feasibility and preliminary efficacy of adding therapeutic ultrasound to a home-based therapeutic exercise program (current standard of care) for patients presenting with oxaliplatin-related pain and sensory disturbance in the hands and feet.
METHODS
Thirty-one colorectal cancer patients with presenting symptoms of peripheral sensory neuropathy, based on a physician-rated grade 1, 2, or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy, were enrolled in the trial. Patients were randomized to either 10 sessions of ultrasound therapy intervention over two-week period (continuous ultrasound at an intensity of 0.7 to 0.8 w/cm 2 , and frequency of 3 MHz for 5 minutes) plus standard care (n = 16) or to standard care alone (n = 15). The feasibility of therapeutic ultrasound was determined by the recruitment rate, participants' adherence to the intervention, and the study completion rates. Assessments of pain, sensory disturbance, sensation, and balance were conducted at baseline, two and six weeks.
RESULTS
We achieved a recruitment rate of 84%, an adherence rate of 100% to the intervention, and a completion rate of 100%. Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (P = 0.003) at two weeks; however, no significance difference between the groups was found at the six-week follow-up.
CONCLUSIONS
The findings of this proof-of-concept study support the feasibility of the therapeutic ultrasound in addition to standard care as an intervention for colorectal cancer patients with oxaliplatin-related pain and sensory disturbance in the hands and feet. The findings warrant a large-scale placebo-controlled trial.",2020,"Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (p =0.003) at two weeks; however, no significance difference between the groups was found at the 6-week follow-up.
","['Patients with Colorectal Cancer', 'Thirty-one colorectal cancer patients with presenting symptoms of peripheral sensory neuropathy, based on a physician rated Grade 1, 2 or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy, were enrolled in the trial', 'patients presenting with oxaliplatin-related pain and sensory disturbance in the hands and feet', 'colorectal cancer patients with']","['therapeutic ultrasound to a home-based therapeutic exercise program (current standard of care', 'ultrasound therapy intervention over two-week period (continuous ultrasound at an intensity of 0.7 to 0.8 w/cm 2 , and frequency of 3 MHz for 5 minutes) plus standard care (N=16) or to standard care alone', 'oxaliplatin']","['symptoms of pain and sensory disturbance', 'adherence rate', 'pain and sensory disturbance', 'pain, sensory disturbance, sensation and balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0235025', 'cui_str': 'Peripheral motor neuropathy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152027', 'cui_str': 'Sensory disorder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0152027', 'cui_str': 'Sensory disorder'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",31.0,0.0553866,"Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (p =0.003) at two weeks; however, no significance difference between the groups was found at the 6-week follow-up.
","[{'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Al Onazi', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Yurick', 'Affiliation': 'Department of Rehabilitation Medicine, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kacy', 'Initials': 'K', 'LastName': 'Nishimura', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Suderman', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Pituskin', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada; Department of Oncology, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Chua', 'Affiliation': 'Department of Oncology, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'McNeely', 'Affiliation': 'Faculty of Rehabilitation Medicine, Department of Physical Therapy, University of Alberta, Edmonton, Alberta, Canada; Department of Rehabilitation Medicine, Cross Cancer Institute, Alberta Health Services, Edmonton, Alberta, Canada. Electronic address: mmcneely@ualberta.ca.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.10.028']
1400,33144141,Control of cardiovascular risk factors with tailored recommendations: A randomized controlled trial.,"This study analyzed the efficacy of tailored recommendations to control cardiovascular risk factors at 1-year follow-up in a population-based randomized controlled trial in individuals aged 35-74 years with no history of cardiovascular disease at baseline. Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP) were measured at baseline and at 1-year follow-up. The primary outcome was the quantitative change in total cholesterol. To estimate the differences within and between groups, McNemar and Student t-tests were applied according to an intention-to-treat strategy. We enrolled 955 individuals [52.3% women; mean age, 50 years (standard deviation 10)]. Finally, 1 participant in each group presented a cardiovascular event and 768 were reexamined at 1-year follow-up. Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively]. Men in the intervention group showed significant decreases in systolic and diastolic BP [117.2 (14.6) to 115.6 mmHg (14.1) and 77.9 (9.7) to 76.5 mmHg (9.7), respectively]; no changes were found in the rates of total cholesterol <5.2 mmol/L and LDL cholesterol <3.0 mmol/L. In the control group, both values were significantly decreased (43.5 to 36.4% and 26.4 to 20.8%, respectively) in men. In the stratified analysis, women showed no differences in any of the outcomes. In conclusion, an intervention with tailored recommendations increased mean total cholesterol values. The intervention effect was higher in men who maintained blood lipids at optimal levels and had decreased BP values.",2020,"Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively].","['We enrolled 955 individuals [52.3% women; mean age, 50\u202fyears (standard deviation 10', 'individuals aged 35-74\u202fyears with no history of cardiovascular disease at baseline']",[],"['systolic and diastolic BP', 'total cholesterol', 'rates of total cholesterol', 'Total, low-density lipoprotein (LDL), and high-density lipoprotein cholesterol and systolic and diastolic blood pressure (BP', 'cardiovascular event', 'BP values', 'quantitative change in total cholesterol', 'mean total cholesterol values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",[],"[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",955.0,0.122144,"Intervention and control groups showed significant increases in total cholesterol [5.49 (standard deviation 1.02) to 5.56 (1.06) mmol/L and 5.34 (0.94) to 5.43 (0.93) mmol/L, respectively].","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Barroso', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Department of Pediatrics, Obstetrics, Gynecology and Preventive Medicine, School of Medicine, Autonomous University of Barcelona, Spain; Eastfield Health, Ashburton, New Zealand.'}, {'ForeName': 'M Dolors', 'Initials': 'MD', 'LastName': 'Zomeño', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; School of Health Sciences, Blanquerna-Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Díaz', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Docent Unit Preventive Medicine and Public Health Parc de Salut Mar, Barcelona Public Health Agency, Pompeu-Fabra University, Barcelona, Spain.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pérez-Fernández', 'Affiliation': 'Regicor Research Group, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Cardiovascular Disease (CIBERCV), Barcelona, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Martí-Lluch', 'Affiliation': 'ISV Girona, IDIAP Jordi Gol, Girona, Catalunya, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cordón', 'Affiliation': 'Primary Care Services, Catalan Institute of Health, Girona, Catalunya, Spain; Department of Medical Sciences, School of Medicine, University of Girona, Spain.'}, {'ForeName': 'Rafel', 'Initials': 'R', 'LastName': 'Ramos', 'Affiliation': 'ISV Girona, IDIAP Jordi Gol, Girona, Catalunya, Spain; Department of Medical Sciences, School of Medicine, University of Girona, Spain; Girona Biomedical Research Institute, Girona, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Cabezas', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Salvador', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Conxa', 'Initials': 'C', 'LastName': 'Castell', 'Affiliation': 'Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schröder', 'Affiliation': 'Cardiovascular Risk and Nutrition, IMIM-Hospital del Mar Medical Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Grau', 'Affiliation': 'Cardiovascular Epidemiology and Genetics Research Group, IMIM-Hospital del Mar Research Institute, Barcelona, Spain; Consortium for Biomedical Research in Epidemiology and Public Health (CIBERESP), Barcelona, Spain; Serra Húnter Fellow, Department of Medicine, University of Barcelona, Barcelona, Spain. Electronic address: mgrau@imim.es.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106302']
1401,33152450,"Safety and efficacy of artemisinin-piperaquine for treatment of COVID-19: an open-label, non-randomised and controlled trial.","BACKGROUND
There are no effective therapies for patients with coronavirus disease-2019 (COVID-19).
METHODS
Forty-one patients with confirmed COVID-19 were enrolled in the study and divided into two groups: artemisinin-piperaquine (AP) (n = 23) and control (n = 18). The primary outcome were the time taken to reach undetectable levels of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) and the percentage of participants with undetectable SARS-CoV-2 on days 7, 10, 14, and 28. The computed tomography (CT) imaging changes within 10 days, corrected QT interval changes, adverse events, and abnormal laboratory parameters were the secondary outcomes.
RESULTS
The mean time to reach undetectable viral RNA (mean ± standard deviation) was 10.6 ± 1.1 days (95% confidence interval [CI] 8.4-12.8) for the AP group and 19.3 ± 2.1 days (95% CI 15.1-23.5) for the control group. The percentages of patients with undetectable viral RNA on days 7, 10, 14, 21, and 28 were 26.1%, 43.5%, 78.3%, 100%, and 100%, respectively, in the AP group and 5.6%, 16.7%, 44.4%, 55.6%, and 72.2%, respectively, in the control group. The CT imaging within 10 days post-treatment showed no significant between-group differences (P > 0.05). Both groups had mild adverse events.
CONCLUSIONS
In patients with mild-to-moderate COVID-19, the time to reach undetectable SARS-CoV-2 was significantly shorter in the AP group than that in the control group. However, physicians should consider QT interval changes before using AP.",2020,The CT imaging within ten days post-treatment showed no significant differences between the two groups (p>0.05).,"['patients with Coronavirus disease-2019 (COVID-19', 'Forty-one patients with confirmed COVID-19 were enrolled in the study and divided into two groups', 'group (n=23) and control group (n=18']","['artemisinin-piperaquine (AP', 'Artemisinin-Piperaquine']","['mild adverse events', 'time to reach undetectable SARS-CoV-2', 'Safety and efficacy', 'time taken to reach undetectable levels of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) and the percentage of participants with undetectable SARS-CoV-2', 'corrected QT interval changes, adverse events, and abnormal laboratory parameters', 'percentage of patients with undetectable viral RNA', 'mean time to reach undetectable viral RNA (mean± standard deviation', 'QT interval changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035736', 'cui_str': 'Viral RNA'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",41.0,0.0774791,The CT imaging within ten days post-treatment showed no significant differences between the two groups (p>0.05).,"[{'ForeName': 'Guoming', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Institute of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated to Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China.""}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated to Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China.""}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yexiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Institute of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Weisheng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Institute of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': ""Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yueming', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""Institute of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Institute of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Chunming', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated to Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China.""}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': ""Department of Surgical Intensive Care Unit, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, People's Republic of China. Electronic address: carlg@163.net.""}, {'ForeName': 'Fengjie', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': ""Department of Intensive Medicine, Hongqi Hospital affiliated to Mudanjiang Medical University, Mudanjiang, Heilongjiang, People's Republic of China. Electronic address: mdjxfj1971@126.com.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ""Institute of Science and Technology Park, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, People's Republic of China; Artemisinin Research Center, Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China. Electronic address: songjp@gzucm.edu.cn.""}]",International journal of antimicrobial agents,['10.1016/j.ijantimicag.2020.106216']
1402,33166726,Short-interval intracortical inhibition as a function of inter-stimulus interval: Three methods compared.,"BACKGROUND
Short-interval intracortical inhibition (SICI), as measured by threshold-tracking as a function of inter-stimulus interval (ISI), has been proposed as a useful biomarker for amyotrophic lateral sclerosis (ALS), but its relationship to conventional amplitude measurements has not been established.
METHODS
Serial tracking of SICI at increasing ISIs from 1 to 7 ms (T-SICIs) was compared in 50 healthy control subjects with the same ISIs tracked in parallel (T-SICIp), and with conventional amplitude measurements (A-SICI). For T-SICIp and A-SICI, pairs of conditioning and test stimuli with different ISIs were pseudo-randomised and interspersed with test-alone stimuli given at regular intervals. Thresholds were estimated by regression of log peak-to-peak amplitude on stimulus.
RESULTS
T-SICIp and A-SICI were closely related: a ten-fold reduction in amplitude corresponding to an approximately 18% increase in threshold. Threshold increases were greater for T-SICIs than for T-SICIp at 3.5-5 ms (P < 0.001). This divergence depended on the initial settings and whether ISIs were progressively increased or decreased, and was attributed to the limitations of the serial tracking protocol. SICI variability between subjects was greatest for T-SICIs estimates and least for A-SICI, and only A-SICI estimates revealed a significant decline in inhibition with age.
CONCLUSIONS
The serial tracking protocol did not accurately show the dependence of inhibition on ISI. Randomising ISIs gives corresponding SICI measures, whether tracking thresholds or measuring amplitude measurements. SICI variability suggested that A-SICI measurements may be the most sensitive to loss of inhibition.",2020,"SICI variability between subjects was greatest for T-SICIs estimates and least for A-SICI, and only A-SICI estimates revealed a significant decline in inhibition with age.
","['50 healthy control subjects with the same ISIs tracked in parallel (T-SICIp), and with conventional amplitude measurements (A-SICI']",[],['SICI variability'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",50.0,0.0606434,"SICI variability between subjects was greatest for T-SICIs estimates and least for A-SICI, and only A-SICI estimates revealed a significant decline in inhibition with age.
","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Tankisi', 'Affiliation': 'Department of Clinical Neurophysiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Bülent', 'Initials': 'B', 'LastName': 'Cengiz', 'Affiliation': 'Department of Neurology, Gazi University Faculty of Medicine, Beşevler, 06500, Ankara, Turkey.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Howells', 'Affiliation': 'Central Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gintaute', 'Initials': 'G', 'LastName': 'Samusyte', 'Affiliation': 'Department of Neurology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Koltzenburg', 'Affiliation': 'Department of Clinical and Movement Neuroscience, UCL Queen Square Institute of Neurology, Queen Square, WC1N 3BG, London, United Kingdom; Department of Clinical Neurophysiology, National Hospital for Neurology and Neurosurgery, Queen Square, WC1N 3BG, London, United Kingdom.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Bostock', 'Affiliation': 'Department of Neuromuscular Diseases, UCL Queen Square Institute of Neurology, Queen Square, WC1N 3BG, London, United Kingdom. Electronic address: H.Bostock@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.11.002']
1403,33166769,The Effect of Hyperglycemia on Infarct Growth after Reperfusion: An Analysis of the DEFUSE 3 trial.,"BACKGROUND AND PURPOSE
Brain infarct growth, despite successful reperfusion, decreases the likelihood of good functional outcome after ischemic stroke. In patients undergoing reperfusion, admission glucose is associated with poor outcome but the effect of glucose level on infarct growth is not well studied.
MATERIALS AND METHODS
This is a secondary analysis of the DEFUSE 3 trial. The primary predictor was baseline glucose level and the primary outcome is the change of the ischemic core volume from the baseline to 24-hour follow-up imaging (∆core), transformed as a cube root to reduce right skew. We included DEFUSE 3 patients who were randomized to endovascular therapy, had perfusion imaging data at baseline, an MRI at 24 hours, and who achieved TICI 2b or 3. Linear regression models, both unadjusted and adjusted, were fit to the primary outcome and all models included the baseline core volume as a covariate to normalize ∆core.
RESULTS
We identified 62 patients who met our inclusion criteria. The mean age was 68.1±13.1 (years), 48.4% (30/62) were men, and the median (IQR) cube root of ∆core was 2.8 (2.0-3.8) mL. There was an association between baseline glucose level and normalized ∆core in unadjusted analysis (beta coefficient 0.010, p = 0.01) and after adjusting for potential confounders (beta coefficient 0.008, p = 0.03).
CONCLUSION
In acute ischemic stroke patients with large vessel occlusion undergoing successful endovascular reperfusion, baseline hyperglycemia is associated with infarction growth. Further study is needed to establish potential neuroprotective benefits of aggressive glycemic control prior to and after reperfusion.",2020,"There was an association between baseline glucose level and normalized ∆core in unadjusted analysis (beta coefficient 0.010, p = 0.01) and after adjusting for potential confounders (beta coefficient 0.008, p = 0.03).
","['62 patients who met our inclusion criteria', 'Infarct Growth after Reperfusion', 'acute ischemic stroke patients with large vessel occlusion undergoing successful endovascular reperfusion, baseline hyperglycemia', 'The mean age was 68.1±13.1 (years), 48.4% (30/62) were men, and the median (IQR) cube root of ∆core was 2.8 (2.0-3.8) mL']","['Hyperglycemia', 'endovascular therapy']","['change of the ischemic core volume from the baseline to 24-hour follow-up imaging (∆core), transformed as a cube root to reduce right skew', 'baseline glucose level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0225990', 'cui_str': 'Large blood vessel structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",62.0,0.177349,"There was an association between baseline glucose level and normalized ∆core in unadjusted analysis (beta coefficient 0.010, p = 0.01) and after adjusting for potential confounders (beta coefficient 0.008, p = 0.03).
","[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'Department of Neurology, NYU Langone Health, 150 55th St Suite 3667, Brooklyn, NY 11220, USA. Electronic address: Shadi.yaghi@nyulangone.org.'}, {'ForeName': 'Seena', 'Initials': 'S', 'LastName': 'Dehkharghani', 'Affiliation': 'Department of Radiology, NYU Langone Health, New York, NY, United States. Electronic address: Seena.Dehkharghani@nyulangone.org.'}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Raz', 'Affiliation': 'Department of Radiology, NYU Langone Health, New York, NY, United States. Electronic address: Eytan.raz@nyulangone.org.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayaraman', 'Affiliation': 'Department of Neurology, Brown University, Providence, RI, United States; Department of Radiology, Brown University, Providence, RI, United States; Department of Neuorosurgery, Brown University, Providence, RI, United States. Electronic address: Mahesh.jayaraman@gmail.com.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Tanweer', 'Affiliation': 'Department of Neurosurgery, NYU Langone Health, New York, NY, United States. Electronic address: Omar.tanweer@nyulangone.org.'}, {'ForeName': 'Brian Mac', 'Initials': 'BM', 'LastName': 'Grory', 'Affiliation': 'Department of Neurology, Duke University, Durham, NC, United States. Electronic address: brian.macgrory@duke.edu.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Henninger', 'Affiliation': 'Department of Neurology, University of Massachusetts, Worcester, MA, United States; Department of Psychiatry, University of Massachusetts, Worcester, MA, United States. Electronic address: nils.henninger@umassmed.edu.'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Department of Neurology, Stanford University, San Francisco, CA, United States. Electronic address: Lansberg@stanford.edu.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Department of Neurology, Stanford University, San Francisco, CA, United States. Electronic address: albers@stanford.edu.'}, {'ForeName': 'Adam de', 'Initials': 'A', 'LastName': 'Havenon', 'Affiliation': 'Department of Neurology, University of Utah Medical Center, Salt Lake City, UT, United States. Electronic address: adam.dehavenon@hsc.utah.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105380']
1404,33177278,"The Impact of Ascidian (Halocynthia roretzi)-derived Plasmalogen on Cognitive Function in Healthy Humans: A Randomized, Double-blind, Placebo-controlled Trial.","OBJECTIVES
Plasmalogen, phospholipids with previously shown associations with dementia, has attracted attention as a substance found in some studies to improve cognitive function. The effects of ascidian-derived plasmalogens on cognitive performance improvement were assessed in a randomized, double-blind, placebo-controlled study including Japanese adult volunteers with mild forgetfulness.
METHODS
Participants consumed either the active food containing ascidian-derived plasmalogen (1 mg as plasmalogen) or the placebo food for 12 weeks, and their cognitive performance was assessed by Cognitrax. Participants were randomly allocated into the intervention (ascidian-derived plasmalogen; 8 males, and 17 females; 45.6 ± 11.1 years) or the placebo (9 males, and 15 females; mean age, 46.4 ± 10.8 years) group.
RESULTS
Compared to the placebo group, the intervention group showed a significant increase score in composite memory (eight weeks: 3.0 ± 16.3 points, 12 weeks: 6.7 ± 17.5 points), which was defined as the sum of verbal and visual memory scores.
CONCLUSIONS
These results indicate the consumption of ascidian-derived plasmalogen maintains and enhances memory function. This study was registered at the University Hospital Medical Information Network Clinical Trial Registry (UMIN-CTR, registry no. UMIN000026297). This study did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.",2020,"Compared to the placebo group, the intervention group showed a significant increase score in composite memory (eight weeks: 3.0 ± 16.3 points, 12 weeks: 6.7 ± 17.5 points), which was defined as the sum of verbal and visual memory scores.
","['Japanese adult volunteers with mild forgetfulness', 'Participants consumed either the', '9 male, and 15 female; mean age, 46.4 ± 10.8 years) group', '8 male, and 17 female; 45.6 ± 11.1 years) or the', 'Healthy Humans']","['active food containing ascidian-derived plasmalogen (1 mg as plasmalogen) or the placebo', 'ascidian-derived plasmalogens', 'placebo', 'Ascidian (Halocynthia roretzi)-derived Plasmalogen', 'Placebo', 'intervention (ascidian-derived plasmalogen']","['cognitive performance improvement', 'sum of verbal and visual memory scores', 'composite memory']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0542476', 'cui_str': 'Forgetful'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0998737', 'cui_str': 'Class Ascidiacea'}, {'cui': 'C0032133', 'cui_str': 'Plasmalogen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0542316', 'cui_str': 'Visual memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.588536,"Compared to the placebo group, the intervention group showed a significant increase score in composite memory (eight weeks: 3.0 ± 16.3 points, 12 weeks: 6.7 ± 17.5 points), which was defined as the sum of verbal and visual memory scores.
","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Sunsho Pharmaceutical Co., Ltd.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Okawara', 'Affiliation': 'Sunsho Pharmaceutical Co., Ltd.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Matahira', 'Affiliation': 'Sunsho Pharmaceutical Co., Ltd.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Mano', 'Affiliation': 'Nihon Pharmaceutical Co., Ltd.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Nihon Pharmaceutical Co., Ltd.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Suzuki', 'Affiliation': 'ORTHOMEDICO Inc.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takara', 'Affiliation': 'Medical Corporation Seishinkai, Takara Clinic.'}]",Journal of oleo science,['10.5650/jos.ess20167']
1405,33179263,Treatment Outcomes in Patients Treated With Galcanezumab vs Placebo: Post Hoc Analyses From a Phase 3 Randomized Study in Patients With Episodic Cluster Headache.,"BACKGROUND
Cluster headache (CH) is a highly disabling primary headache disorder. To date, characterization of outcomes in the preventive treatment of episodic CH, including precise definitions of clinically meaningful attack frequency reduction and impact on acute treatment management, is lacking.
METHODS
This was a Phase 3, randomized, double-blind, placebo-controlled study in patients (men or women aged 18-65 years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria. In this post hoc analysis, we evaluated the median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attack frequency, and impact on acute medication use. An anchor-based assessment of clinically relevant attack frequency reduction using the Patient Global Impression of Improvement (PGI-I) scores at Week 4 was also assessed.
RESULTS
The median time-to-first occurrence of ≥50, ≥75, or 100% reduction from baseline in CH attacks was consistently shorter (9-10 days sooner) with galcanezumab vs placebo (median [95% confidence interval, 95% CI]: ≥50%, 5 days [4.0 to 7.0] vs 14 days [6.0 to 19.0]; ≥75%, 11 days [7.0 to 16.0] vs 21 days [13.0 to 26.0]; 100%, 22 days [16.0 to 37.0] vs 32 days [23.0 to 34.0]). Mean reduction from baseline in the overall frequency of weekly pooled acute medication use across Weeks 1-3 was significantly greater with galcanezumab vs placebo (11.0 vs 5.5; odds ratio, OR [95% CI]: 5.52 [1.02, 10.01]; P value = .017). Patients reporting ""much better"" on the PGI-I experienced a median weekly CH attack reduction of approximately 43% from baseline across Weeks 1-3. The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]).
CONCLUSIONS
Faster median time-to-first occurrence of response rates, lower frequency of pooled acute medications use, and a greater proportion of patients achieving a response anchored by patient-reported improvement were observed for galcanezumab vs placebo.",2020,"The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]).
","['Patients With Episodic Cluster Headache', 'patients (men or women aged 18-65\xa0years) diagnosed with episodic CH as defined by the International Classification of Headache Disorders-3 beta criteria']","['placebo', 'galcanezumab vs placebo', 'Galcanezumab vs Placebo']","['median time-to-first occurrence', 'CH attacks', 'overall odds of achieving an attack reduction', 'median weekly CH attack reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393739', 'cui_str': 'Episodic cluster headache'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0393735', 'cui_str': 'Headache disorder'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]",,0.635537,"The overall odds of achieving an attack reduction threshold of 43% across Weeks 1-3 was significantly higher with galcanezumab vs placebo (Weeks 1-3: OR [95% CI], 2.60 [1.3 to 5.3]).
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'J Scott', 'Initials': 'JS', 'LastName': 'Andrews', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Rettiganti', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Oakes', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bardos', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Charly', 'Initials': 'C', 'LastName': 'Gaul', 'Affiliation': 'Migraine and Headache Clinic, Koenigstein, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riesenberg', 'Affiliation': 'Atlanta Center for Medical Research, Atlanta, GA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wenzel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Dulanji', 'Initials': 'D', 'LastName': 'Kuruppu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.14011']
1406,33181456,Smartwatches are more distracting than mobile phones while driving: Results from an experimental study.,"The use of smartwatches raises a number of questions about their potential for distraction in situations where sustained attention is paramount, like driving a motor vehicle. Our research examines distraction caused by smartwatch use in comparison to mobile phone use while driving. It also studies the difference in distractions caused by inbound text messages versus inbound voice messages, and outbound replies through text messages versus outbound voice replies. A within-subject experiment was conducted in a driving simulator where 31 participants received and answered text messages under four conditions: they received notifications (1) on a mobile phone, (2) on a smartwatch, and (3) on a speaker, and then responded orally to these messages. They also (4) received messages in a ""texting"" condition where they had to reply through text to the notifications. Eye tracking gaze distribution results show that participants were more distracted in the smartwatch condition than in the mobile phone condition, they were less distracted in the speaker condition than in the phone condition, and they were more distracted in the texting condition than in any of the others. The participants' driving performance remained the same in all conditions except in the texting condition, wherein it became worse. Eye tracking and pupillometry results suggest that participants' mental workload might be lower in the texting condition than in the other three conditions, although this result might be caused by a higher number of glances at the device in that condition. This study contributes to a better understanding of the distraction potential of smartwatches as well as identifying vocal assistants as the least distracting way of communicating while driving a vehicle. Industry leaders could become a key factor in informing the public of the smartwatch's potential for distraction.",2020,"Eye tracking gaze distribution results show that participants were more distracted in the smartwatch condition than in the mobile phone condition, they were less distracted in the speaker condition than in the phone condition, and they were more distracted in the texting condition than in any of the others.",[],[],[],[],[],[],31.0,0.0253588,"Eye tracking gaze distribution results show that participants were more distracted in the smartwatch condition than in the mobile phone condition, they were less distracted in the speaker condition than in the phone condition, and they were more distracted in the texting condition than in any of the others.","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Brodeur', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: mathieu.2.brodeur@hec.ca.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Ruer', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: perrine.ruer@hec.ca.'}, {'ForeName': 'Pierre-Majorique', 'Initials': 'PM', 'LastName': 'Léger', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: pierre-majorique.leger@hec.ca.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Sénécal', 'Affiliation': 'Tech3Lab, HEC Montréal 5540 Ave Louis Colin, Montréal, Quebec, H3T 2A7, Canada. Electronic address: sylvain.senecal@hec.ca.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105846']
1407,33132156,Characterization of retinal microvasculature and its relations to cognitive function in older people after circuit resistance training.,"PURPOSE
To characterize the changes of retinal microvascular density and their relations to cognitive function in the healthy older people without known cognitive impairment after an 8-week high-speed circuit resistance training program (HSCT).
METHODS
Twenty cognitively normal older people were recruited and randomly assigned to either the HSCT group or control group (CON). Twelve subjects (age 70.8 ± 5.8 yrs) in the HSCT group trained three times per week for 8 weeks. Eight subjects in the CON group (age 71.8 ± 4.8 yrs) did not perform formal training. Both eyes of each subject were imaged using optical coherence tomography angiography (OCTA) at baseline and at 8-week follow-up. The densities of the retinal vascular network (RVN), superficial vascular plexus (SVP), and deep vascular plexus (DVP) were measured. In addition, their cognitive functions were tested using the NIH toolbox.
RESULTS
There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group. Although the vessel densities did not differ between visits in either group, the variation (i.e., change) in retinal vessel density of SVP was negatively related to the changes of FCS (r = -0.54, P = 0.007) and the List Sorting Working Memory test (r = -0.43, P = 0.039) in the HSCT group.
CONCLUSIONS
This is the first study to reveal that the individual response of the SVD was related to the improvement in the cognition in cognitively normal older people after HSCT.",2020,"There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group.","['Eight subjects in the CON group (age 71.8\xa0±\xa04.8\xa0yrs) did not perform formal training', 'healthy older people without known cognitive impairment after an 8-week high', 'cognitively normal older people after HSCT', 'Twenty cognitively normal older people', 'Twelve subjects (age 70.8\xa0±\xa05.8\xa0yrs) in the', 'older people after circuit resistance training']","['optical coherence tomography angiography (OCTA', 'HSCT group or control group (CON', 'speed circuit resistance training program (HSCT', 'HSCT']","['List Sorting Working Memory test', 'vessel densities', 'pattern comparison processing speed (PAT, P\xa0=\xa00.02) and fluid composite score', 'retinal vessel density of SVP', 'densities of the retinal vascular network (RVN), superficial vascular plexus (SVP), and deep vascular plexus (DVP']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517796', 'cui_str': '5.8'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C4517398', 'cui_str': '0.02'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035330', 'cui_str': 'Structure of blood vessel of retina'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",20.0,0.0222647,"There were significant increases in pattern comparison processing speed (PAT, P = 0.02) and fluid composite score (FCS, P = 0.005) at the follow-up in the HSCT group.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Shenzhen Key Laboratory of Ophthalmology, Shenzhen Eye Hospital, Jinan University, Shenzhen, China; Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Keri', 'Initials': 'K', 'LastName': 'Strand', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Totillo', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; School of Ophthalmology and Optometry, Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Signorile', 'Affiliation': 'Department of Kinesiology and Sports Sciences, University of Miami, FL, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA; Department of Neurology, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: hjiang@med.miami.edu.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Experimental gerontology,['10.1016/j.exger.2020.111114']
1408,33141921,Differential Effects of Clopidogrel With or Without Aspirin on Platelet Reactivity and Coagulation Activation: A Randomized Trial in Healthy Volunteers.,"Dual antiplatelet therapy (DAPT) is standard in acute coronary syndrome but confers a bleeding risk. To compare effects of clopidogrel single antiplatelet therapy (SAPT) with clopidogrel-based DAPT on hemostatic system activation we conducted a randomized clinical trial in 44 volunteers (clopidogrel (d1: 600 mg, d2-6: 150 mg) ± aspirin (100 mg)). Multiple electrode aggregometry-adenosine diphosphate (MEA-ADP) and MEA-arachidonic acid (MEA-AA) triggered aggregometry, vasodilator-stimulated phosphoprotein (VASP), beta thromboglobulin, p-selectin, thromboxane B 2 , d-Dimer, prothrombin fragment 1.2 (f1.2), and a phospholipid-dependent clotting time were measured in venous blood. Changes are described by mean differences (Δmean (95% confidence interval (CI)) or geometric mean ratios (95% CI)). DAPT and SAPT comparably and significantly decreased MEA-ADP at 2 hours (-60% vs. -63%; P = 0.35, Δmean -4.9, 95% CI -15.4 to 5.5). At 24 hours (-59% vs. -47%, P = 0.04, Δmean -11.1, 95% CI -21.7 to -0.4]) and 8 days (-61% vs. -53%, P = 0.04, Δmean -11.3, 95% CI -22.0 to -0.6). Both treatments significantly reduced VASP and MEA-AA after 2 hours and 8 days. DAPT inhibited MEA-AA significantly stronger at 2 hours (-77% vs. -30%; P < 0.0001, Δmean -39.6, 95% CI -54.2 to -25.0), at 24 hours (-80% vs. -27%, P < 0.0001, Δmean -47.8, 95% CI -62.3 to -33.3), and 8 days (-79% vs. -27%, P < 0.0001, Δmean -48.9, 95% CI -62.5 to -35.4). Neither treatment significantly influenced beta thromboglobulin or p-selectin. DAPT abolished and SAPT reduced thromboxane B 2 after 24 hours and 8 days. The d-Dimer was reduced by DAPT (0.94, 95% CI 0.89-1.00, P = 0.04) at 2 hours but not after 24 hours and 8 days. SAPT did not decrease d-Dimer. Neither treatment affected f1.2. DAPT and SAPT comparably affect platelet and coagulation activation in venous blood.",2020,"DAPT inhibited MEA-AA significantly stronger at 2h (-77% vs -30%; p<0.0001, Δmean -39.6 [-54.2; -25.0]), at 24h (-80% vs -27%, p<0.0001, Δmean -47.8 [-62.3; -33.3]), and 8 days (-79% vs -27%, p<0.0001, Δmean -48.9 [-62.5; -35.4]).","['44 volunteers (clopidogrel [d1: 600mg, d2-6: 150 mg] ', 'healthy volunteers']","['clopidogrel single antiplatelet therapy (SAPT) with clopidogrel-based DAPT', 'Dual antiplatelet therapy (DAPT', 'Clopidogrel with or without Aspirin', 'Adenosine diphosphate (MEA-ADP) and arachidonic acid (MEA-AA', 'aspirin', 'SAPT', 'DAPT and SAPT']","['DAPT inhibited MEA-AA', 'VASP and MEA-AA', 'MEA-ADP', 'Platelet Reactivity and Coagulation Activation', 'platelet and coagulation activation']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0010648', 'cui_str': 'Cysteamine'}, {'cui': 'C0255567', 'cui_str': 'vasodilator-stimulated phosphoprotein'}, {'cui': 'C0001459', 'cui_str': 'Adenosine diphosphate'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}]",44.0,0.0619473,"DAPT inhibited MEA-AA significantly stronger at 2h (-77% vs -30%; p<0.0001, Δmean -39.6 [-54.2; -25.0]), at 24h (-80% vs -27%, p<0.0001, Δmean -47.8 [-62.3; -33.3]), and 8 days (-79% vs -27%, p<0.0001, Δmean -48.9 [-62.5; -35.4]).","[{'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Traby', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'Kollars', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kaider', 'Affiliation': 'Center for Medical Statistics Informatics and Intelligent Systems, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jolanta Maria', 'Initials': 'JM', 'LastName': 'Siller-Matula', 'Affiliation': 'Department of Medicine II, Division of Cardiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Steinbrecher', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wolzt', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Paul Alexander', 'Initials': 'PA', 'LastName': 'Kyrle', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Eichinger', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2106']
1409,33144086,Efficacy and safety of dapagliflozin in acute heart failure: Rationale and design of the DICTATE-AHF trial.,"BACKGROUND
Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor, reduces cardiovascular death and worsening heart failure in patients with chronic heart failure and reduced ejection fraction. Early initiation during an acute heart failure (AHF) hospitalization may facilitate decongestion, improve natriuresis, and facilitate safe transition to a beneficial outpatient therapy for both diabetes and heart failure.
OBJECTIVE
The objective is to assess the efficacy and safety of initiating dapagliflozin within the first 24 hours of hospitalization in patients with AHF compared to usual care.
METHODS
DICTATE-AHF is a prospective, multicenter, open-label, randomized trial enrolling a planned 240 patients in the United States. Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 mL/min/1.73m 2 are eligible for participation. Patients are randomly assigned 1:1 to dapagliflozin 10 mg once daily or structured usual care until day 5 or hospital discharge. Both treatment arms receive protocolized diuretic and insulin therapies. The primary endpoint is diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose in 40 mg intravenous furosemide equivalents. Secondary and exploratory endpoints include inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis. Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.
CONCLUSIONS
The DICTATE-AHF trial will establish the efficacy and safety of early initiation of dapagliflozin during AHF across both AHF and diabetic outcomes in patients with diabetes.",2020,"Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.
","['planned 240 patients in the United States', 'patients with chronic heart failure and reduced ejection fraction', 'Acute Heart Failure', 'Patients with type 2 diabetes hospitalized with hypervolemic AHF and an estimated glomerular filtration rate of at least 30 ml/min/1.73m 2 are eligible for participation', 'patients with diabetes', 'patients with AHF compared to usual care']","['dapagliflozin 10mg once daily or structured usual care until day 5 or hospital discharge', 'protocolized diuretic and insulin therapies', 'Dapagliflozin', 'dapagliflozin']","['diuretic response expressed as the cumulative change in weight per cumulative loop diuretic dose', 'incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality', 'efficacy and safety', 'inpatient worsening AHF, 30-day hospital readmission for AHF or diabetic reasons, change in NT-proBNP, and measures of natriuresis', 'Efficacy and Safety', 'cardiovascular death']","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]","[{'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0752266', 'cui_str': 'Hypovolemic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027477', 'cui_str': 'Natriuresis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0905358,"Safety endpoints include the incidence of hyper/hypoglycemia, ketoacidosis, worsening kidney function, hypovolemic hypotension, and inpatient mortality.
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, TN; Department of Pharmacy, Vanderbilt University Medical Center, Nashville, TN. Electronic address: Zachary.l.cox@vumc.org.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Aaron', 'Affiliation': 'Department of Cardiac Sciences, Saint Thomas West Hospital, Nashville, TN.'}, {'ForeName': 'Gabriel A', 'Initials': 'GA', 'LastName': 'Hernandez', 'Affiliation': 'Division of Cardiology, University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'A Thomas McRae', 'Initials': 'ATM', 'LastName': 'Iii', 'Affiliation': 'TriStar Centennial Medical Center, Nashville, TN.'}, {'ForeName': 'Beth T', 'Initials': 'BT', 'LastName': 'Davidson', 'Affiliation': 'TriStar Centennial Medical Center, Nashville, TN.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fowler', 'Affiliation': 'Division of Diabetes, Endocrinology, and Metabolism, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Frank E Harrell', 'Initials': 'FEH', 'LastName': 'Jr', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Jenkins', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kampe', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Karen F', 'Initials': 'KF', 'LastName': 'Miller', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Stubblefield', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Division of Cardiology, Vanderbilt University Medical Center, Nashville, TN.'}]",American heart journal,['10.1016/j.ahj.2020.10.071']
1410,33145862,"Acetaminophen, Nonsteroidal Anti-inflammatory Drugs, or Combination of Both Analgesics in Acute Posttrauma Pain: A Randomized Controlled Trial.","OBJECTIVES
Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (also called paracetamol) are the most frequent analgesics used to relieve posttrauma pain in the emergency department (ED). However, the utility of combining both treatments is still controversial. We sought to explore the benefits of combining an NSAID with acetaminophen compared to acetaminophen alone, or NSAID alone, in the treatment of posttraumatic pain of the extremity after discharge from the ED.
METHODS
This is a prospective, randomized controlled trial, carried out in a single ED from March 2017 to November 2018. The included patients were randomly assigned to receive paracetamol alone, high-dose NSAID (piroxicam) alone, or a combination of paracetamol and high-dose NSAID for 7 days after ED discharge. The primary outcome was need for additional oral analgesics. Secondary outcomes included the change of the visual numeric scale (VNS) between ED discharge (VNS D0) and 7 days later (VNS D7), ED revisits for residual pain, side effects, and patient satisfaction as assessed by a Likert satisfaction scale.
RESULTS
The need for additional oral analgesics was comparable between the paracetamol-NSAID combination group (9.8%) and the paracetamol group (11.4%; p = 0.43). ED readmission rate was also comparable between the two groups at 5.6 and 5.8%, respectively (p = 0.86). In contrast, need for new analgesics and ED revisit rates were both more frequent in the high-dose NSAID group. Mean VNS decreases on day 7 compared to day 0 were 66, 63, and 67%, respectively, in the paracetamol, NSAID, and paracetamol-NSAID combination groups (p = 0.32). Frequency of dissatisfaction was higher in the NSAID group. Side effects were more frequent in the NSAID and paracetamol-NSAID combination groups.
CONCLUSION
This study found that the combination of a high-dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high-dose NSAID alone for posttraumatic extremity pain.",2020,"Mean VNS decrease on D7 compared to D0 was 66%, 63% and 67%, respectively in paracetamol group,","['post-traumatic pain of the extremity after discharge from the emergency department (ED', 'acute post-trauma pain', 'single ED from March 2017 to November 2018']","['acetaminophen alone, or NSAID alone', 'paracetamol-NSAID combination', 'paracetamol alone, or high-dose NSAID (piroxicam) alone, or a combination of paracetamol and high-dose NSAID', 'Paracetamol or nonsteroidal anti-inflammatory drugs or combination of both analgesics', 'acetaminophen (also called paracetamol', 'NSAID and paracetamol-NSAID combination', 'NSAID with acetaminophen', 'paracetamol']","['Mean VNS decrease on D7', 'need for additional oral analgesics', 'Frequency of dissatisfaction', 'Side effects', 'analgesic effect', 'change of the visual numeric scale (VNS) between ED discharge (VNS D0) and 7 days later (VNS D7), ED revisits for residual pain, side effects and patient satisfaction as assessed by a Likert satisfaction scale', 'ED readmission rate', 'new analgesics and ED revisit rates']","[{'cui': 'C1611174', 'cui_str': 'Post-traumatic pain'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C3805255', 'cui_str': 'Residual pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205314', 'cui_str': 'New'}]",,0.110333,"Mean VNS decrease on D7 compared to D0 was 66%, 63% and 67%, respectively in paracetamol group,","[{'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Msolli', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Sekma', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Toumia', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Khaoula', 'Initials': 'K', 'LastName': 'Bel Haj Ali', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Mohamed Hassen', 'Initials': 'MH', 'LastName': 'Khalil', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Mohamed Habib', 'Initials': 'MH', 'LastName': 'Grissa', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Wahid', 'Initials': 'W', 'LastName': 'Bouida', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Kaouthar', 'Initials': 'K', 'LastName': 'Beltaief', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Zorgati', 'Affiliation': 'the, Emergency Department, Sahloul University Hospital, Sousse, Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Methamem', 'Affiliation': 'the, Emergency Department, Farhat Hached University Hospital, Sousse, Tunisia.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Belguith', 'Affiliation': 'and the, Department of Preventive Medicine, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Riadh', 'Initials': 'R', 'LastName': 'Boukef', 'Affiliation': 'the, Research Laboratory LR12SP18, University of Monastir, Monastir, Tunisia.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Boubaker', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Semir', 'Initials': 'S', 'LastName': 'Nouira', 'Affiliation': 'From the, Emergency Department, Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14169']
1411,33146763,"Safety and cost-effectiveness of individualised screening for diabetic retinopathy: the ISDR open-label, equivalence RCT.","AIMS/HYPOTHESIS
Using variable diabetic retinopathy screening intervals, informed by personal risk levels, offers improved engagement of people with diabetes and reallocation of resources to high-risk groups, while addressing the increasing prevalence of diabetes. However, safety data on extending screening intervals are minimal. The aim of this study was to evaluate the safety and cost-effectiveness of individualised, variable-interval, risk-based population screening compared with usual care, with wide-ranging input from individuals with diabetes.
METHODS
This was a two-arm, parallel-assignment, equivalence RCT (minimum 2 year follow-up) in individuals with diabetes aged 12 years or older registered with a single English screening programme. Participants were randomly allocated 1:1 at baseline to individualised screening at 6, 12 or 24 months for those at high, medium and low risk, respectively, as determined at each screening episode by a risk-calculation engine using local demographic, screening and clinical data, or to annual screening (control group). Screening staff and investigators were observer-masked to allocation and interval. Data were collected within the screening programme. The primary outcome was attendance (safety). A secondary safety outcome was the development of sight-threatening diabetic retinopathy. Cost-effectiveness was evaluated within a 2 year time horizon from National Health Service and societal perspectives.
RESULTS
A total of 4534 participants were randomised. After withdrawals, there were 2097 participants in the individualised screening arm and 2224 in the control arm. Attendance rates at first follow-up were equivalent between the two arms (individualised screening 83.6%; control arm 84.7%; difference -1.0 [95% CI -3.2, 1.2]), while sight-threatening diabetic retinopathy detection rates were non-inferior in the individualised screening arm (individualised screening 1.4%, control arm 1.7%; difference -0.3 [95% CI -1.1, 0.5]). Sensitivity analyses confirmed these findings. No important adverse events were observed. Mean differences in complete case quality-adjusted life-years (EuroQol Five-Dimension Questionnaire, Health Utilities Index Mark 3) did not significantly differ from zero; multiple imputation supported the dominance of individualised screening. Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs. Overall, 43.2% fewer screening appointments were required in the individualised arm.
CONCLUSIONS/INTERPRETATION
Stakeholders involved in diabetes care can be reassured by this study, which is the largest ophthalmic RCT in diabetic retinopathy screening to date, that extended and individualised, variable-interval, risk-based screening is feasible and can be safely and cost-effectively introduced in established systematic programmes. Because of the 2 year time horizon of the trial and the long time frame of the disease, robust monitoring of attendance and retinopathy rates should be included in any future implementation.
TRIAL REGISTRATION
ISRCTN 87561257 FUNDING: The study was funded by the UK National Institute for Health Research. Graphical abstract.",2021,"Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs.","['diabetic retinopathy', 'individuals with diabetes', 'individuals with diabetes aged 12\xa0years or older registered with a single English screening programme', '4534 participants were randomised', '2097 participants in the individualised screening arm and 2224 in the control arm']","['individualised screening', 'individualised, variable-interval, risk-based population screening compared with usual care']","['development of sight-threatening diabetic retinopathy', 'while sight-threatening diabetic retinopathy detection rates', 'safety and cost-effectiveness', 'Safety and cost-effectiveness', 'Attendance rates', 'Incremental cost savings per person with individualised screening', 'adverse events', 'complete case quality-adjusted life-years (EuroQol Five-Dimension Questionnaire, Health Utilities Index Mark 3', 'Cost-effectiveness', 'overall programme costs', 'attendance (safety']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2733251', 'cui_str': 'EuroQoL five dimension questionnaire'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",4534.0,0.329272,"Incremental cost savings per person with individualised screening were £17.34 (95% CI 17.02, 17.67) from the National Health Service perspective and £23.11 (95% CI 22.73, 23.53) from the societal perspective, representing a 21% reduction in overall programme costs.","[{'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Broadbent', 'Affiliation': 'Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK. deborah.broadbent@rlbuht.nhs.uk.'}, {'ForeName': 'Amu', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cheyne', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lathe', 'Affiliation': 'Division of Rehabilitation, Ageing and Wellbeing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Stratton', 'Affiliation': 'Gloucestershire Retinal Research Group, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Mersey Diabetes Support Group, Liverpool, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Moitt', 'Affiliation': 'Clinical Trials Research Centre, Liverpool, UK.'}, {'ForeName': 'Jiten P', 'Initials': 'JP', 'LastName': 'Vora', 'Affiliation': 'Department of Diabetes and Endocrinology, Royal Liverpool University Hospital, Liverpool, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Gabbay', 'Affiliation': 'Department of Health Services Research, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Member of Liverpool Health Partners, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetologia,['10.1007/s00125-020-05313-2']
1412,33152277,"Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial.","BACKGROUND
10-year results from several studies showed improved disease-free survival and distant metastasis-free survival, reduced breast cancer-related mortality, and variable effects on overall survival with the addition of partial or comprehensive regional lymph node irradiation after surgery in patients with breast cancer. We present the scheduled 15-year analysis of the European Organisation for Research and Treatment of Cancer (EORTC) 22922/10925 trial, which aims to investigate the impact on overall survival of elective internal mammary and medial supraclavicular (IM-MS) irradiation.
METHODS
EORTC 22922/10925, a randomised, phase 3 trial done across 46 radiation oncology departments from 13 countries, included women up to 75 years of age with unilateral, histologically confirmed, stage I-III breast adenocarcinoma with involved axillary nodes or a central or medially located primary tumour. Surgery consisted of mastectomy or breast-conserving surgery and axillary staging. Patients were randomly assigned (1:1) centrally using minimisation to receive IM-MS irradiation at 50 Gy in 25 fractions (IM-MS irradiation group) or no IM-MS irradiation (control group). Stratification was done for institution, menopausal status, site of the primary tumour within the breast, type of breast and axillary surgery, and pathological T and N stage. Patients and investigators were not masked to treatment allocation. The primary endpoint was overall survival analysed according to the intention-to-treat principle. Secondary endpoints were disease-free survival, distant metastasis-free survival, breast cancer mortality, any breast cancer recurrence, and cause of death. Follow-up is ongoing for 20 years after randomisation. This study is registered with ClinicalTrials.gov, NCT00002851.
FINDINGS
Between Aug 5, 1996, and Jan 13, 2004, we enrolled 4004 patients, of whom 2002 were randomly assigned to the IM-MS irradiation group and 2002 to the no IM-MS irradiation group. At a median follow-up of 15·7 years (IQR 14·0-17·6), 554 (27·7%) patients in the IM-MS irradiation group and 569 (28·4%) patients in the control group had died. Overall survival was 73·1% (95% CI 71·0-75·2) in the IM-MS irradiation group and 70·9% (68·6-72·9) in the control group (HR 0·95 [95% CI 0·84-1·06], p=0·36). Any breast cancer recurrence (24·5% [95% CI 22·5-26·6] vs 27·1% [25·1-29·2]; HR 0·87 [95% CI 0·77-0·98], p=0·024) and breast cancer mortality (16·0% [14·3-17·7] vs 19·8% [18·0-21·7]; 0·81 [0·70-0·94], p=0·0055) were lower in the IM-MS irradiation group than in the control group. No significant differences in the IM-MS irradiation group versus the control group were seen for disease-free survival (60·8% [95% CI 58·4-63·2] vs 59·9% [57·5-62·2]; HR 0·93 [95% CI 0·84-1·03], p=0·18), or distant metastasis-free survival (70·0% [67·7-72·2] vs 68·2% [65·9-70·3]; 0·93 [0·83-1·04], p=0·18). Causes of death between groups were similar.
INTERPRETATION
The 15-year results show a significant reduction of breast cancer mortality and any breast cancer recurrence by IM-MS irradiation in stage I-III breast cancer. However, this is not converted to improved overall survival.
FUNDING
US National Cancer Institute, Ligue Nationale contre le Cancer, and KWF Kankerbestrijding.",2020,"No significant differences in the IM-MS irradiation group versus the control group were seen for disease-free survival (60·8% [95% CI 58·4-63·2] vs 59·9% [57·5-62·2]; HR 0·93 [95% CI 0·84-1·03], p=0·18), or distant metastasis-free survival (70·0% [67·7-72·2] vs 68·2% [65·9-70·3]; 0·93 [0·83-1·04], p=0·18).","['I-III breast adenocarcinoma with involved axillary nodes or a central or medially located primary tumour', 'stage I-III breast cancer', 'Between Aug 5, 1996, and Jan 13, 2004, we enrolled 4004 patients', 'stage I-III breast cancer (EORTC 22922/10925', 'patients with breast cancer', '46 radiation oncology departments from 13 countries, included women up to 75 years of age with unilateral, histologically confirmed, stage']","['IM-MS irradiation group and 2002 to the no IM-MS irradiation group', 'IM-MS irradiation', 'elective internal mammary and medial supraclavicular (IM-MS) irradiation', 'Internal mammary and medial supraclavicular lymph node chain irradiation', 'IM-MS irradiation at 50 Gy in 25 fractions (IM-MS irradiation group) or no IM-MS irradiation (control group', 'Surgery consisted of mastectomy or breast-conserving surgery and axillary staging']","['overall survival', 'Overall survival', 'Cancer (EORTC', 'breast cancer mortality', 'breast cancer recurrence', 'breast cancer mortality and any breast cancer recurrence', 'disease-free survival', 'distant metastasis-free survival', 'died', 'disease-free survival and distant metastasis-free survival, reduced breast cancer-related mortality', 'disease-free survival, distant metastasis-free survival, breast cancer mortality, any breast cancer recurrence, and cause of death']","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0858252', 'cui_str': 'Breast adenocarcinoma'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0229730', 'cui_str': 'Structure of supraclavicular lymph node'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0332305', 'cui_str': 'With staging'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",4004.0,0.270225,"No significant differences in the IM-MS irradiation group versus the control group were seen for disease-free survival (60·8% [95% CI 58·4-63·2] vs 59·9% [57·5-62·2]; HR 0·93 [95% CI 0·84-1·03], p=0·18), or distant metastasis-free survival (70·0% [67·7-72·2] vs 68·2% [65·9-70·3]; 0·93 [0·83-1·04], p=0·18).","[{'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Poortmans', 'Affiliation': 'Department of Radiation Oncology, Iridium Kankernetwerk, Wilrijk-Antwerp, Belgium; Faculty of Medicine and Health Sciences, University of Antwerp, Wilrijk-Antwerp, Belgium. Electronic address: philip.poortmans@telenet.be.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Weltens', 'Affiliation': 'Department of Radiation Oncology, University Hospital Leuven, Leuven, Belgium; Department of Oncology, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fortpied', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Kirkove', 'Affiliation': 'Department of Radiation Oncology, University Hospital Saint Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Peignaux-Casasnovas', 'Affiliation': 'Department of Radiation Oncology, Centre Georges François Leclerc, Dijon, France.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Budach', 'Affiliation': 'Department of Radiation Oncology and Radiotherapy, Comprehensive Cancer Center, Charite University Medicine, Berlin, Germany.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van der Leij', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Vonk', 'Affiliation': 'Radiotherapiegroep, Deventer, Netherlands.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Weidner', 'Affiliation': 'Department of Radiation Oncology, University Hospital, Tübingen, Germany.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Rivera', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Centre, Villejuif, France.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'van Tienhoven', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Netherlands.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Fourquet', 'Affiliation': 'Department of Radiation Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Noel', 'Affiliation': 'Department of Radiation Oncology, Institut de Cancérologie Strasbourg-Europe, Strasbourg, France.'}, {'ForeName': 'Mariacarla', 'Initials': 'M', 'LastName': 'Valli', 'Affiliation': 'Department of Radiation Oncology, Sant Anna Hospital, Como, Italy.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Guckenberger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Koiter', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Racadot', 'Affiliation': 'Department of Radiation Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Roxolyana', 'Initials': 'R', 'LastName': 'Abdah-Bortnyak', 'Affiliation': 'Department of Radiation Oncology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Erik F', 'Initials': 'EF', 'LastName': 'Van Limbergen', 'Affiliation': 'Department of Radiation Oncology, University Hospital Leuven, Leuven, Belgium; Department of Oncology, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Engelen', 'Affiliation': 'Department of Radiation Oncology, Institute Verbeeten, Tilburg, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'De Brouwer', 'Affiliation': 'Department of Radiation Oncology, Institute Verbeeten, Tilburg, Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Struikmans', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Bartelink', 'Affiliation': 'Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30472-1']
1413,33152284,"Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial.","BACKGROUND
Preoperative and perioperative aromatase inhibitor (POAI) therapy has the potential to improve outcomes in women with operable oestrogen receptor-positive primary breast cancer. It has also been suggested that tumour Ki67 values after 2 weeks (Ki67 2W ) of POAI predicts individual patient outcome better than baseline Ki67 (Ki67 B ). The POETIC trial aimed to test these two hypotheses.
METHODS
POETIC was an open-label, multicentre, parallel-group, randomised, phase 3 trial (done in 130 UK hospitals) in which postmenopausal women aged at least 50 years with WHO performance status 0-1 and hormone receptor-positive, operable breast cancer were randomly assigned (2:1) to POAI (letrozole 2·5 mg per day orally or anastrozole 1 mg per day orally) for 14 days before and following surgery or no POAI (control). Adjuvant treatment was given as per UK standard local practice. Randomisation was done centrally by computer-generated permuted block method (variable block size of six or nine) and was stratified by hospital. Treatment allocation was not masked. The primary endpoint was time to recurrence. A key second objective explored association between Ki67 (dichotomised at 10%) and disease outcomes. The primary analysis for clinical endpoints was by modified intention to treat (excluding patients who withdrew consent). For Ki67 biomarker association and endpoint analysis, the evaluable population included all randomly assigned patients who had paired Ki67 values available. This study is registered with ClinicalTrials.gov, NCT02338310; the European Clinical Trials database, EudraCT2007-003877-21; and the ISRCTN registry, ISRCTN63882543. Recruitment is complete and long-term follow-up is ongoing.
FINDINGS
Between Oct 13, 2008, and April 16, 2014, 4480 women were recruited and randomly assigned to POAI (n=2976) or control (n=1504). On Feb 6, 2018, median follow-up was 62·9 months (IQR 58·1-74·1). 434 (10%) of 4480 women had a breast cancer recurrence (280 [9%] POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75-1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9-92·0) for patients in the POAI group and 90·4% (88·7-91·9) in the control group. Within the POAI-treated HER2-negative subpopulation, 5-year recurrence risk in women with low Ki67 B and Ki67 2W (low-low) was 4·3% (95% CI 2·9-6·3), 8·4% (6·8-10·5) with high Ki67 B and low Ki67 2W (high-low) and 21·5% (17·1-27·0) with high Ki67 B and Ki67 2W (high-high). Within the POAI-treated HER2-positive subpopulation, 5-year recurrence risk in the low-low group was 10·1% (95% CI 3·2-31·3), 7·7% (3·4-17·5) in the high-low group, and 15·7% (10·1-24·4) in the high-high group. The most commonly reported grade 3 adverse events were hot flushes (20 [1%] of 2801 patients in the POAI group vs six [<1%] of 1400 in the control group) and musculoskeletal pain (29 [1%] vs 13 [1%]). No treatment-related deaths were reported.
INTERPRETATION
POAI has not been shown to improve treatment outcome, but can be used without detriment to help select appropriate adjuvant therapy based on tumour Ki67. Most patients with low Ki67 B or low POAI-induced Ki67 2W do well with adjuvant standard endocrine therapy (giving consideration to clinical-pathological factors), whereas those whose POAI-induced Ki67 2W remains high might benefit from further adjuvant treatment or trials of new therapies.
FUNDING
Cancer Research UK.",2020,"POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75-1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9-92·0) for patients in the POAI group and 90·4% (88·7-91·9) in the control group.","['postmenopausal women with hormone-sensitive early breast cancer (POETIC', '130 UK hospitals) in which postmenopausal women aged at least 50 years with WHO performance status 0-1 and hormone receptor-positive, operable breast cancer', 'Between Oct 13, 2008, and April 16, 2014, 4480', '4480 women had a breast cancer recurrence (280 [9', 'women with operable oestrogen receptor-positive primary breast cancer']","['letrozole 2·5 mg per day orally or anastrozole', 'POAI ', 'POAI) therapy', 'POAI', 'perioperative aromatase inhibitor', 'perioperative endocrine therapy']","['musculoskeletal pain', '5-year recurrence risk', 'time to recurrence', 'breast cancer recurrence', 'grade 3 adverse events']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034804', 'cui_str': 'Estrogen receptor'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",4480.0,0.222093,"POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75-1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9-92·0) for patients in the POAI group and 90·4% (88·7-91·9) in the control group.","[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK; The Institute of Cancer Research, London, UK. Electronic address: poetic-icrctsu@icr.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, UK; University Hospitals of Derby and Burton, Derby, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Kilburn', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Wilcox', 'Affiliation': 'Independent Cancer Patients Voice, London, UK.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Holcombe', 'Affiliation': 'Liverpool University Hospitals Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Horgan', 'Affiliation': 'Bexley Cancer Centre, Leeds, UK.'}, {'ForeName': 'Cliona', 'Initials': 'C', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester and Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Mallon', 'Affiliation': 'Queen Elizabeth University Hospital Glasgow, Govan, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sibbering', 'Affiliation': 'University Hospitals of Derby and Burton, Derby, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Skene', 'Affiliation': 'Royal Bournemouth and Christchurch NHS Foundation Trust, Bournemouth, UK.'}, {'ForeName': 'Raghavan', 'Initials': 'R', 'LastName': 'Vidya', 'Affiliation': 'University of Birmingham and Royal Wolverhampton NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Cheang', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Banerji', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morden', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kally', 'Initials': 'K', 'LastName': 'Sidhu', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dodson', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK; The Institute of Cancer Research, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30458-7']
1414,33157357,Effects of modified version of the Hospital Elder Life Program on post-discharge cognitive function and activities of daily living among older adults undergoing total knee arthroplasty.,"OBJECTIVES
This study aimed to investigate the effects of a modified Hospital Elder Life Program (mHELP) on post-discharge cognition and physical function among older adults undergoing total knee arthroplasty (TKA), and to evaluate the incidence of postoperative delirium.
DESIGN
Non-randomized intervention trial.
SETTING AND PARTICIPANTS
A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included.
METHODS
Ward-level stratification was used with one surgical ward receiving mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group). All participants were assigned to two surgical wards. Outcome measures were collected using MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments at 1, 6, and 12 months after discharge. Multiple linear regression analysis was used to measure effects of mHELP intervention on mean differences in tMMSE, ADL and IADL scores from baseline to 1-, 6- and 12-months.
RESULTS
Effects of mHELP intervention significantly preserved cognitive function at 1 and 12 months, but not at 6 months, compared with controls, regardless of adjustments for confounders. However, no intervention effects were noted in ADL and IADL scores. Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
CONCLUSIONS
mHELP intervention preserves post-discharge cognitive function, but has no notable effect on ADL and IADL function in older adults undergoing elective TKA surgery.",2020,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","['older adults undergoing total knee arthroplasty', 'older adults undergoing elective TKA surgery', 'A total of 140 patients aged 60 years and older scheduled for elective orthopedic surgery at our institution between August 2017 and December 2018 were included', 'older adults undergoing total knee arthroplasty (TKA']","['modified version of the Hospital Elder Life Program', 'mHELP (intervention group), including orientation communication, early mobilization, vision/hearing impairment equipment, and dehydration prevention, and another ward providing usual care (control group', 'mHELP intervention', 'modified Hospital Elder Life Program (mHELP']","['MMSE telephone version (tMMSE), activities of daily living (ADL) and instrumental activities of daily living (IADL) instruments', 'tMMSE, ADL and IADL scores', 'ADL and IADL scores', 'cognitive function', 'Postoperative delirium']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013459', 'cui_str': 'Early Mobilization'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}]",140.0,0.0811517,"Postoperative delirium in the whole cohort was 3.6 % (2.5 % in intervention group, 5.1 % in control group, P = 0.41).
","[{'ForeName': 'Chih-Kuang', 'Initials': 'CK', 'LastName': 'Liang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Che-Sheng', 'Initials': 'CS', 'LastName': 'Chu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Ying-Hsin', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Ming-Yueh', 'Initials': 'MY', 'LastName': 'Chou', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Aging and Health Research Center, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Wang', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Chia Nan University of Pharmacy and Science, Tainan, Taiwan.'}, {'ForeName': 'Yu-Te', 'Initials': 'YT', 'LastName': 'Lin', 'Affiliation': 'Center for Geriatrics and Gerontology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Division of Neurology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Jenn-Huei', 'Initials': 'JH', 'LastName': 'Renn', 'Affiliation': 'Department of Orthopaedics, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Medical Affair Administration, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Tsung-Yun', 'Initials': 'TY', 'LastName': 'Liu', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Chang', 'Initials': 'CC', 'LastName': 'Yang', 'Affiliation': 'Institute of Environmental and Occupational Health Sciences, School of Medicine, National Yang Ming University, Taipei, Taiwan; Division of Clinical Toxicology & Occupational Medicine, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. Electronic address: ccyang@vghtpe.gov.tw.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104284']
1415,33157378,The effects of the Australian bushfires on physical activity in children.,"OBJECTIVES
To determine the impact of bushfires on children's physical activity.
DESIGN
Natural experiment comparing device-measured physical activity and air quality index data for schools exposed and not exposed to the Australian bushfires.
METHODS
Participants were drawn from 22 schools participating in a cluster randomised controlled trial of a school-based physical activity intervention that coincided with the 2019 Australian bushfires. Students in Years 3 and 4 (8-10 years old) provided data. We used propensity score matching to match 245 exposed and 344 control participants.
MAIN OUTCOME MEASURES
Minutes of moderate and vigorous physical activity.
RESULTS
The bushfires had minimal effect on children's average weekly physical activity. Analysis of acute effects showed children maintained their levels of physical activity up to an estimated turning point of air quality index of 737.08 (95% CI = 638.63, 835.53), beyond which daily physical activity levels dropped sharply. Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
CONCLUSIONS
Children's physical activity was not strongly influenced by the presence of smoke and targeted public health advice during the bushfires might not have had the intended effect of reducing children's outdoor physical activity. Only when air quality deteriorated to approximately 3.5 times the Air Quality index threshold (>200) deemed 'hazardous' by the Australian Department of Health did children's physical activity decline. Public health agencies should re-evaluate the effectiveness of health messages during bushfires and develop strategies to mitigate risks to children's health.",2020,"Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
","['344 control participants', 'schools exposed and not exposed to the Australian bushfires', 'Students in Years 3 and 4 (8-10\xa0years old) provided data', 'children', 'Participants were drawn from 22 schools participating in a cluster randomised controlled trial of a']",['school-based physical activity intervention'],"['Minutes of moderate and vigorous physical activity', 'daily physical activity levels', 'physical activity and air quality index data', 'physical activity']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0469317,"Similar results were found for girls and boys and for children from low-to-average and higher socio-economic backgrounds.
","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Del Pozo Cruz', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia. Electronic address: Borja.delPozoCruz@acu.edu.au.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hartwig', 'Affiliation': 'Faculty of Health Sciences, School of Behavioural and Health Sciences, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Taren', 'Initials': 'T', 'LastName': 'Sanders', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Noetel', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia; School of Behavioural and Health Sciences, Australian Catholic University, Queensland, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Parker', 'Affiliation': 'Positive Psychology Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Devan', 'Initials': 'D', 'LastName': 'Antczak', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, Faculty of Education and Arts, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Bauman', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Cerin', 'Affiliation': 'Behaviour, Environment and Cognition Research Program, Mary Mackillop Institute for Health Research, Faculty of Health Sciences, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lonsdale', 'Affiliation': 'Motivation and Behaviour Research Program, Institute for Positive Psychology and Education, Australian Catholic University, New South Wales, Australia.'}]",Environment international,['10.1016/j.envint.2020.106214']
1416,33159002,The Effectiveness of Working Memory Training for Children With Low Working Memory.,"OBJECTIVES
Subgroups of children may benefit more from working memory training than others. In this study, we aimed to examine whether response to the Cogmed Working Memory Training program differed for children with low IQ and elevated attention-deficit/hyperactivity disorder, emotional and behavioral symptoms, special health care needs, or by sex.
METHODS
We used data from the Memory Maestros trial, a population-based randomized controlled trial of the Cogmed program delivered at school ( n = 226) compared to usual teaching ( n = 226) in grade 1 children (mean age 6.9 years; SD 0.4) with low working memory. Cogmed comprises 20 to 25 sessions of 45-minute duration over 5 to 7 weeks. Children completed subtests from the Automated Working Memory Assessment to measure change in working memory from baseline to 6 months postrandomization.
RESULTS
After training, improved working memory standard scores (>1 SD) from baseline to 6 months were observed for approximately one-third of the children, with more than half maintaining stable scores (within 1 SD). However, similar outcomes were observed for children receiving usual teaching. Differential effect of Cogmed versus usual teaching was evident for children with elevated hyperactivity and/or inattention, who were less likely to show improved visuospatial working memory, but not for other subgroups studied.
CONCLUSIONS
Children with elevated hyperactivity and/or inattention were less likely to show clinically meaningful improvement after Cogmed; however, differential effects were not evident for children with low IQ and elevated emotional and behavioral symptoms, special health care needs, or by sex. More research is needed to determine if training can improve working memory and, if so, for whom.",2020,"Differential effect of Cogmed versus usual teaching was evident for children with elevated hyperactivity and/or inattention, who were less likely to show improved visuospatial working memory, but not for other subgroups studied.
","[' n = 226) in grade 1 children (mean age 6.9 years; SD 0.4) with low working memory', 'children with low IQ and elevated attention-deficit/hyperactivity disorder, emotional and behavioral symptoms, special health care needs, or by sex', 'children with elevated hyperactivity and/or inattention', 'Children With Low Working Memory']","['Cogmed Working Memory Training program', 'Working Memory Training', 'Cogmed program delivered at school ( n = 226) compared to usual teaching', 'Cogmed versus usual teaching']","['working memory standard scores', 'visuospatial working memory']","[{'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0424101', 'cui_str': 'Inattention'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.188132,"Differential effect of Cogmed versus usual teaching was evident for children with elevated hyperactivity and/or inattention, who were less likely to show improved visuospatial working memory, but not for other subgroups studied.
","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Spencer-Smith', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia; megan.spencer-smith@monash.edu.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Quach', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Mensah', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Gehan', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gathercole', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, University of Cambridge, Cambridge, United Kingdom; and.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wake', 'Affiliation': 'Population Health Theme, and.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Anderson', 'Affiliation': 'Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Clayton, Victoria, Australia.'}]",Pediatrics,['10.1542/peds.2019-4028']
1417,33156692,"Foot Core Training to Prevent Running-Related Injuries: A Survival Analysis of a Single-Blind, Randomized Controlled Trial.","BACKGROUND
Running-related injuries (RRIs) are a pervasive menace that can interrupt or end the participation of recreational runners in this healthy physical activity. To date, no satisfactory treatment has been developed to prevent RRIs.
PURPOSE
To investigate the efficacy of a novel foot core strengthening protocol based on a ground-up approach to reduce the incidence of RRIs in recreational long-distance runners over the course of a 1-year follow-up.
STUDY DESIGN
Randomized controlled trial; Level of evidence, 1.
METHODS
The participants, 118 runners, were assessed at baseline and randomly allocated to either an intervention group (n = 57) or a control group (n = 61). The intervention group received an 8-week training course focused on the foot-ankle muscles, followed by remotely supervised training thereafter. Assessments consisted of 3 separate biomechanical evaluations of foot strength and foot posture and a weekly report on each participant's running distance, pace, and injury incidence over 12 months.
RESULTS
The control group participants were 2.42 times (95% CI, 1.98-3.62) more likely to experience an RRI within the 12-month study period than participants in the intervention group ( P = .035). Time to injury was significantly correlated with Foot Posture Index ( P = .031; r = 0.41) and foot strength gain ( P = .044; r = 0.45) scores. This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training.
CONCLUSION
Recreational runners randomized to the new foot core strengthening protocol had a 2.42-fold lower rate of RRIs compared with the control group. Further studies are recommended to better understand the underlying biomechanical mechanisms of injury, types of injuries, and subgroups of runners who might benefit maximally.
REGISTRATION
NCT02306148 (ClinicalTrials.gov identifier).",2020,"This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training.
","['recreational runners', 'Running-Related Injuries', 'The participants, 118 runners']","['novel foot core strengthening protocol', 'Foot Core Training', '8-week training course focused on the foot-ankle muscles, followed by remotely supervised training thereafter']","['foot strength gain', 'effective RRI risk reduction', 'Foot Posture Index', 'rate of RRIs']","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",,0.161311,"This foot exercise program showed evidence of effective RRI risk reduction in recreational runners at 4 to 8 months of training.
","[{'ForeName': 'Ulisses T', 'Initials': 'UT', 'LastName': 'Taddei', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alessandra B', 'Initials': 'AB', 'LastName': 'Matias', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Duarte', 'Affiliation': 'Biomedical Engineering, Federal University of ABC, São Paulo, Brazil.'}, {'ForeName': 'Isabel C N', 'Initials': 'ICN', 'LastName': 'Sacco', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of São Paulo, São Paulo, Brazil.'}]",The American journal of sports medicine,['10.1177/0363546520969205']
1418,33160091,Feasibility and preliminary efficacy of a positive psychology-based intervention to promote health behaviors in heart failure: The REACH for Health study.,"OBJECTIVE
Most patients with heart failure (HF) struggle to adhere to health behaviors, and existing health behavior interventions have significant limitations. We developed a 12-week, phone-delivered, combined positive psychology (PP) and motivational interviewing (MI) intervention to promote well-being and adherence to physical activity, diet, and medications. In this three-arm, randomized trial, we assessed the feasibility, acceptability, and preliminary efficacy of the intervention compared to treatment as usual and MI-alone conditions in 45 patients with HF and suboptimal health behavior adherence.
METHODS
Participants in the PP-MI or MI-alone conditions completed weekly phone sessions for 12 weeks. Those in PP-MI completed weekly PP exercises and set health behavior goals, while those in the MI-alone condition learned about HF-specific health behaviors and identified potential behavior changes. Primary study outcomes were feasibility (sessions completed) and acceptability (0-10 ratings of PP exercise ease and utility). The intervention's impact on psychological and behavioral outcomes was assessed using mixed effects regression analyses.
RESULTS
Participants in the PP-MI condition completed 73% of sessions and rated PP exercises as easy to complete (mean = 7.5 [SD 1.7] out of 10) and subjectively useful (mean = 7.5 [SD 1.6] out of 10). Compared to the control conditions, PP-MI led to medium effect-size improvements in positive affect (Cohen's d = 0.32-0.77), moderate to vigorous physical activity (d = 0.41-0.74), and medication adherence (d = 0.48-0.78).
CONCLUSION
This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes. Larger trials are needed to examine this intervention's impact on health behavior adherence and other important outcomes (NCT03220204).",2020,"This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes.","['patients with heart failure (HF', 'Participants in the PP-MI or MI-alone conditions completed weekly phone sessions for 12\xa0weeks', '45 patients with HF and suboptimal health behavior adherence', 'heart failure']","['positive psychology-based intervention', 'combined positive psychology (PP) and motivational interviewing (MI) intervention to promote well-being and adherence to physical activity, diet, and medications']","['health behavior adherence', 'feasibility (sessions completed) and acceptability (0-10 ratings of PP exercise ease and utility', 'psychological and behavioral outcomes', 'moderate to vigorous physical activity', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",45.0,0.039932,"This PP-MI intervention was feasible, well-accepted, and associated with promising improvements in well-being and health behavior outcomes.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA. Electronic address: ccelano@mgh.harvard.edu.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Freedman', 'Affiliation': 'Department of Psychology, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Harnedy', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Baim Institute for Clinical Research, Boston, MA, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': ""Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA; Departments of Neurology and Biostatistics, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110285']
1419,33160115,Safety and efficacy of apixaban thromboprophylaxis in cancer patients with metastatic disease: A post-hoc analysis of the AVERT trial.,"BACKGROUND
The risk of venous thromboembolism (VTE) is increased in patients with active cancer and the risk is highest in those with metastatic disease. The risks and benefits of thromboprophylaxis among cancer patients with metastatic disease initiating chemotherapy treatment are unknown. To address this important knowledge gap, we evaluated the efficacy and safety of apixaban thromboprophylaxis in patients with and without metastatic disease.
METHODS
Post-hoc analysis of the AVERT trial, which was a randomized, placebo-controlled, double-blind trial comparing apixaban therapy to placebo for VTE prophylaxis among cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy. The hazards ratios (HRs) for VTE and major bleeding episodes in patients with and without metastatic disease were calculated using a Cox regression model controlling for age, gender, and center.
RESULTS
A total of 574 patients underwent randomization and 365 patients could be stratified according to the presence (n = 138) or absence (n = 227) of metastatic disease. In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo. In patients without metastatic disease, the use of apixaban was also associated with a significantly lower risk of VTE (HR 0.34 95% CI 0.19 to 0.60) without a significant increase in major bleeding complications (HR 1.14 95% CI 0.08 to 15.91).
CONCLUSIONS
In patients with and without metastatic disease, apixaban thromboprophylaxis was associated with a significantly lower rate of VTE compared to placebo.",2020,"In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo.","['patients with active cancer', 'cancer patients with metastatic disease initiating', 'patients with and without metastatic disease', 'cancer patients who were intermediate-to-high risk for VTE and who were initiating chemotherapy', '574 patients underwent randomization and 365 patients could be stratified according to the presence (n\xa0=\xa0138) or absence (n\xa0=\xa0227) of metastatic disease', 'cancer patients with metastatic disease']","['apixaban therapy to placebo', 'placebo', 'apixaban thromboprophylaxis', 'chemotherapy']","['hazards ratios (HRs) for VTE and major bleeding episodes', 'Safety and efficacy', 'efficacy and safety', 'rate of VTE', 'risk of VTE', 'major bleeding complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3160769', 'cui_str': 'Major bleed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",574.0,0.339079,"In patients with metastatic disease, those receiving apixaban had a significantly lower risk of VTE (HR 0.55; 95% CI 0.32 to 0.97) without a significant increase in major bleeding complications (HR 1.36 95% CI 0.27 to 6.93) compared to those on placebo.","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Knoll', 'Affiliation': ""Faculty of Medicine, Queen's University, Kingston, Canada; Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada.""}, {'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Mallick', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Wells', 'Affiliation': 'Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Department of Medicine University of Ottawa, the Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: mcarrier@toh.ca.'}]",Thrombosis research,['10.1016/j.thromres.2020.10.026']
1420,33186858,Quality of life with adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected stage II-IIIA (N1-N2) EGFR-mutant non-small-cell lung cancer: Results from the ADJUVANT (CTONG1104) study.,"OBJECTIVES
Health-related quality of life (HRQoL) data complement conventional clinical endpoints when comparing adjuvant gefitinib with chemotherapy in patients with early-stage non-small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations. This study aimed to assess changes in HRQoL with adjuvant gefitinib vs chemotherapy in this patient group.
MATERIALS AND METHODS
In the phase III ADJUVANT trial, patients with completely resected, stage II-IIIA (N1-N2), EGFR-mutant NSCLC were randomized (1:1) to receive either gefitinib for 24 months or vinorelbine plus cisplatin (VP) every 3 weeks for four cycles. HRQoL was assessed as a secondary endpoint using the Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Lung Cancer Symptom Scale (LCSS) questionnaires, and Trial Outcome Index (TOI) composite score. HRQoL dynamics, improvements, and time to deterioration were compared between groups.
RESULTS
At baseline, 104 of 106, and 80 of 87 patients receiving gefitinib and VP, respectively, completed two questionnaires (FACT-L and LCSS). Baseline scores were balanced between groups. Although HRQoL fluctuated and gradually improved in both groups, longitudinally higher scores were reported with gefitinib than VP (FACT-L, odds ratio 418.16, 95 % confidence interval [CI] 2.75-63509.05, p = 0.019; LCSS, 1.13, 1.04-1.22, p = 0.003; TOI, 88.39, 4.40-1775.05, p = 0.003). Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p = 0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p = 0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p = 0.001).
CONCLUSION
Adjuvant gefitinib is associated with improved HRQoL over VP, supporting its use in patients with stage II-IIIA (N1-N2), EGFR-mutant NSCLC.",2020,"Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p = 0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p = 0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p = 0.001).
","['patients with early-stage non-small-cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutations', 'patients with completely resected, stage II-IIIA (N1-N2), EGFR-mutant', 'patients with completely resected stage II-IIIA (N1-N2) EGFR-mutant non-small-cell lung cancer', 'patients with stage II-IIIA (N1-N2), EGFR-mutant NSCLC']","['gefitinib vs chemotherapy', 'adjuvant gefitinib versus vinorelbine plus cisplatin', 'gefitinib with chemotherapy', 'Adjuvant gefitinib', 'gefitinib', 'vinorelbine plus cisplatin (VP']","['HRQoL', 'Quality of life', 'Functional Assessment of Cancer Therapy-Lung Cancer (FACT-L), Lung Cancer Symptom Scale (LCSS) questionnaires, and Trial Outcome Index (TOI) composite score', 'HRQoL dynamics, improvements, and time to deterioration', 'Time to deterioration in HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",,0.335678,"Time to deterioration in HRQoL was delayed with gefitinib compared with VP (FACT-L, median 69 vs 6 weeks, hazard ratio 0.62, 95 % CI 0.42-0.90, p = 0.013; LCSS, median 45 vs 6 weeks, 0.63, 0.43-0.93, p = 0.020; TOI, median 164 vs 9 weeks, 0.51, 0.33-0.77, p = 0.001).
","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China. Electronic address: maowm@zjcc.org.cn.'}, {'ForeName': 'Qi-Xun', 'Initials': 'QX', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Tao-Bo', 'Initials': 'TB', 'LastName': 'Luo', 'Affiliation': 'Department of Thoracic Surgery, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Xue-Ning', 'Initials': 'XN', 'LastName': 'Yang', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Hong-Hong', 'Initials': 'HH', 'LastName': 'Yan', 'Affiliation': ""Department of Pulmonary Cancer, Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Wen-Zhao', 'Initials': 'WZ', 'LastName': 'Zhong', 'Affiliation': ""Department of Pulmonary Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Song-Tao', 'Initials': 'ST', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Affiliated Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary Medicine, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Yong-Yu', 'Initials': 'YY', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Liaoning Cancer Hospital, Shenyang, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, Jilin Provincial Tumor Hospital, Changchun, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, The People's Hospital of Peking University, Beijing, China.""}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, Tangdu Hospital, Xi'an, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Pulmonary Oncology, Fujian Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Zhi-Dong', 'Initials': 'ZD', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Beijing Chest Hospital, Beijing, China.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ke-Neng', 'Initials': 'KN', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Shi-Dong', 'Initials': 'SD', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lun-Xu', 'Initials': 'LX', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of Thoracic Oncology, Sichuan Cancer Hospital, Chengdu, China.'}, {'ForeName': 'Bu-Hai', 'Initials': 'BH', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, The Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Ma', 'Affiliation': 'Department of Thoracic Surgery, The First Affiliated Hospital of Suzhou University, Suzhou, China.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.09.027']
1421,33186890,Prediction of cancer-specific survival and overall survival in middle-aged and older patients with rectal adenocarcinoma using a nomogram model.,"OBJECTIVE
To develop a new nomogram tool for predicting survival in middle-aged and elderly patients with rectal adenocarcinoma.
METHODS
A total of 6,116 patients were randomly assigned in a 7:3 ratio to training and validation cohorts. Univariate and multivariate Cox proportional hazards regression analyses were used to identify independent prognostic factors associated with overall survival (OS) and cancer-specific survival (CSS) in the training set, and two nomogram prognostic models were constructed. The validity, accuracy, discrimination, predictive ability, and clinical utility of the models were assessed based on the concordance index (C-index), area under the receiver operating characteristics (ROC) curve, time-dependent area under the ROC curve (AUC), Kaplan-Meier survival curve, and decision curve analyses.
RESULTS
Predictors of OS and CSS were identified, and nomograms were successfully constructed. The calibration discrimination for both the OS and CSS nomogram prediction models was good (C-index: 0.763 and 0.787, respectively). The AUC showed excellent predictive performance, and the calibration curve exhibited significant predictive power for both nomograms. The time-dependent AUC showed that the predictive ability of the predictor-based nomogram was better than that of the TNM stage. The nomograms successfully discriminated high-, medium-, and low-risk patients for all-cause and cancer-specific mortality. The decision curve demonstrated that the nomograms are useful with respect to good decision power.
CONCLUSION
Our nomogram survival prediction models may aid in evaluating the prognosis of middle-aged and older patients with rectal adenocarcinoma and guiding the selection of the clinical treatment measures.",2020,"The calibration discrimination for both the OS and CSS nomogram prediction models was good (C-index: 0.763 and 0.787, respectively).","['6,116 patients', 'middle-aged and older patients with rectal adenocarcinoma', 'middle-aged and older patients with rectal adenocarcinoma using a nomogram model', 'middle-aged and elderly patients with rectal adenocarcinoma']",[],"['validity, accuracy, discrimination, predictive ability, and clinical utility', 'overall survival (OS) and cancer-specific survival (CSS', 'concordance index (C-index), area under the receiver operating characteristics (ROC) curve, time-dependent area under the ROC curve (AUC), Kaplan-Meier survival curve, and decision curve analyses', 'cancer-specific survival and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C1450294', 'cui_str': 'Nomogram chart'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0035787', 'cui_str': 'ROC Analysis'}]",6116.0,0.053162,"The calibration discrimination for both the OS and CSS nomogram prediction models was good (C-index: 0.763 and 0.787, respectively).","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Lv', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Yidan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': 'Rheumatology and Immunology Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Ziweng', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Junjiang', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.'}, {'ForeName': 'Dasen', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'General Surgery Department, Zaozhuang Municipal Hospital, Qingdao, Shandong, China.'}, {'ForeName': 'Hexiang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Radiology Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. Electronic address: 18661808669@126.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'General Surgery Department, Affiliated Hospital of Qingdao University, Qingdao, Shandong, China. Electronic address: drjianzhang@126.com.'}]",Translational oncology,['10.1016/j.tranon.2020.100938']
1422,33189179,Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.,"BACKGROUND
Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception.
METHODS
We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete).
FINDINGS
Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred.
INTERPRETATION
Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception.
FUNDING
National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).",2020,"No serious adverse events occurred.
","['29 UK pharmacies among women receiving levonorgestrel emergency contraception', 'Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate', 'women presenting to community pharmacies for emergency contraception (Bridge-It', 'Most women in the UK obtain emergency contraception from community pharmacies', 'Between Dec 19, 2017, and June 26, 2019', '636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1']","['progestogen-only pill with emergency contraception', '3-month supply of the progestogen-only pill (75 μg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic', 'progestogen-only pill']","['use of effective contraception (hormonal or intrauterine', 'proportion of women using effective contraception']","[{'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0420857', 'cui_str': 'Progestogen only oral contraceptive'}, {'cui': 'C0558252', 'cui_str': 'Emergency contraception'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",636.0,0.116296,"No serious adverse events occurred.
","[{'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Cameron', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK; Chalmers Sexual and Reproductive Health, NHS Lothian, Edinburgh, UK. Electronic address: sharon.cameron@ed.ac.uk.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McDaid', 'Affiliation': 'Institute for Social Science Research, The University of Queensland, Brisbane, QLD, Australia; MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'Directorate of Public Health, NHS Tayside, Dundee, UK; Division of Cardiovascular Medicines and Diabetes, Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Baraitser', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Stephenson', 'Affiliation': ""Elizabeth Garrett Anderson Institute for Women's Health, University College London, London, UK.""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Gilson', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Battison', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Cowle', 'Affiliation': 'Boots UK, Edinburgh, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forrest', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Johnstone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Morelli', 'Affiliation': ""Department of Sexual Health, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Patterson', 'Affiliation': 'MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Thenmalar', 'Initials': 'T', 'LastName': 'Vadiveloo', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31785-2']
1423,33189635,Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2.,"OBJECTIVES
This study sought to better understand the discrepant results of 2 trials of serelaxin on acute heart failure (AHF) and short-term mortality after AHF by analyzing causes of death of patients in the RELAX-AHF-2 (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF-2) trial.
BACKGROUND
Patients with AHF continue to suffer significant short-term mortality, but limited systematic analyses of causes of death in this patient population are available.
METHODS
Adjudicated cause of death of patients in RELAX-AHF-2, a randomized, double-blind, placebo-controlled trial of serelaxin in patients with AHF across the spectrum of ejection fraction (EF), was analyzed.
RESULTS
By 180 days of follow-up, 11.5% of patients in RELAX-AHF-2 died, primarily due to heart failure (HF) (38% of all deaths). Unlike RELAX-AHF, there was no apparent effect of treatment with serelaxin on any category of cause of death. Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and noncardiovascular (CV) death (27% vs. 19%) compared to younger patients. Patients with preserved EF (≥50%) had lower rates of HF-related mortality (30% vs. 40%) but higher non-CV mortality (36% vs. 20%) compared to patients with reduced EF.
CONCLUSIONS
Despite previous data suggesting benefit of serelaxin in AHF, treatment with serelaxin was not found to improve overall mortality or have an effect on any category of cause of death in RELAX-AHF-2. Careful adjudication of events in the serelaxin trials showed that older patients and those with preserved EF had fewer deaths from HF or sudden death and more deaths from other CV causes and from noncardiac causes. (Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF [RELAX-AHF-2]; NCT01870778).",2020,Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and non-cardiovascular (CV) death (27% vs. 19%) compared to younger patients.,"['patients with AHF across the spectrum of ejection fraction (EF), was analyzed', 'Patients With Acute Heart', 'Adjudicated cause of death of patients in RELAX-AHF-2', 'Patients with AHF', 'Older patients (≥75 years']","['serelaxin', 'placebo', 'Serelaxin']","['heart failure (HF', 'acute heart failure (AHF', 'Efficacy, Safety and Tolerability', 'non-cardiovascular (CV) death', 'CV mortality', 'Cause of Death', 'rates of HF-related mortality', 'rates of mortality', 'overall mortality', 'deaths from HF or sudden death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}]",,0.323088,Older patients (≥75 years) had higher rates of mortality (14.2% vs. 8.8%) and non-cardiovascular (CV) death (27% vs. 19%) compared to younger patients.,"[{'ForeName': 'Rahul S', 'Initials': 'RS', 'LastName': 'Loungani', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California, San Francisco, California, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Cardiology, ASST Civil Hospitals, and Department of Medical and Surgical Specialties, Radiological Sciences and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson, Mississippi, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Carson', 'Affiliation': 'Department of Cardiology, Washington VA Medical Center, Washington, DC, USA.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Durham, North Carolina, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Durham, North Carolina, USA.'}, {'ForeName': 'Zubin J', 'Initials': 'ZJ', 'LastName': 'Eapen', 'Affiliation': 'Anthem Incorporated, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gerasimos S', 'Initials': 'GS', 'LastName': 'Filippatos', 'Affiliation': 'School of Medicine, University of Cyprus, Nicosia, Cyprus, Greece; Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Gimpelewicz', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Greenberg', 'Affiliation': 'University of California San Diego Health, Cardiovascular Institute, La Jolla, California, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holbro', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Harvard Medical School, and Cardiometabolic Trials, Baim Institute for Clinical Research, Boston, Massachusetts, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, Michigan, USA.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Department of Emergency Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Division of Cardiology, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Cardiology, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Miller', 'Affiliation': 'Department of Cardiology, University of Florida, Jacksonville, Florida, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Division of Cardiology and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA. Electronic address: Michael.felker@duke.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.09.010']
1424,33189801,Rechargeable adhesive with calcium phosphate nanoparticles inhibited long-term dentin demineralization in a biofilm-challenged environment.,"OBJECTIVES
This study aims to investigate the long-term demineralization-inhibition capability of a rechargeable adhesive with nanoparticles of amorphous calcium phosphate (NACP) on dentin in a biofilm-challenged environment.
METHODS
The NACP adhesive was immersed in a pH 4 solution to exhaust calcium (Ca) and phosphate (P) ions and then recharged with Ca and P ions. Dentin samples were demineralized underStreptococcus mutans biofilms for 24 h and randomly divided into two groups: (1) dentin control, (2) dentin with recharged NACP adhesives. Each day, all the samples were immersed in brain heart infusion broth with 1% sucrose (BHIS) for 4 h, and then in artificial saliva (AS) for 20 h. This cycle was repeated for 10 days. The pH of BHIS, the Ca and P ions content of the BHIS and AS were measured daily. After 10 days, the lactic acid production and colony-forming units of the biofilms were tested. The changes of remineralization/demineralization were also analyzed.
RESULTS
Dentin in the control group showed further demineralization. The recharged NACP adhesive neutralized acids, increasing the pH to above 5, and released large amounts of Ca and P ions each day. The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
CONCLUSIONS
The NACP adhesive could continuously inhibit dentin demineralization in a biofilm-challenged environment by recharging with Ca and P ions.
SIGNIFICANCE
The rechargeable NACP adhesive could provide long-term dentin bond protection.",2020,"The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
",[],"['amorphous calcium phosphate (NACP', 'dentin control, (2) dentin with recharged NACP adhesives', 'pH 4 solution to exhaust calcium (Ca) and phosphate (P) ions and then recharged with Ca and P ions']","['lactic acid production and colony-forming units of the biofilms', 'changes of remineralization/demineralization', 'pH of BHIS, the Ca and P ions content of the BHIS and AS', 'demineralization', 'dentin hardness', 'production of lactic acid']",[],"[{'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0022023', 'cui_str': 'Ions'}]","[{'cui': 'C0064582', 'cui_str': 'lactic acid'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700185', 'cui_str': 'Decalcified structure'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0036088', 'cui_str': 'Artificial saliva'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",,0.0188217,"The recharged NACP adhesive decreased the production of lactic acid (P < 0.05), inhibited dentin demineralization and sustained the dentin hardness in the biofilm-challenged environment, showing an excellent long-term demineralization-inhibition capability.
","[{'ForeName': 'Zhaohan', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Siying', 'Initials': 'S', 'LastName': 'Tao', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hockin H K', 'Initials': 'HHK', 'LastName': 'Xu', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Weir', 'Affiliation': 'Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA.'}, {'ForeName': 'Menglin', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Yifang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Xuedong', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Kunneng', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China; Department of Advanced Oral Sciences and Therapeutics, University of Maryland School of Dentistry, Baltimore, MD 21201, USA. Electronic address: kunnengliang@163.com.'}, {'ForeName': 'Jiyao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Cariology and Endodontics, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China. Electronic address: jiyaoliscu@163.com.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103529']
1425,33189805,The effect of airway management on CPR quality in the PARAMEDIC2 randomised controlled trial.,"INTRODUCTION
Good quality basic life support (BLS) is associated with improved outcome from cardiac arrest. Chest compression fraction (CCF) is a BLS quality indicator, which may be influenced by the type of airway used. We aimed to assess CCF according to the airway strategy in the PARAMEDIC2 study: no advanced airway, supraglottic airway (SGA), tracheal intubation, or a combination of the two. Our hypothesis was that tracheal intubation was associated with a decrease in the CCF compared with alternative airway management strategies.
METHODS
PARAMEDIC2 was a multicentre double-blinded placebo-controlled trial of adrenaline vs placebo in out-of-hospital cardiac arrest. Data showing compression rate and ratio from patients recruited by London Ambulance Service (LAS) as part of this study was collated and analysed according to the advanced airway used during the resuscitation attempt.
RESULTS
CPR process data were available from 286/ 2058 (13.9%) of the total patients recruited by LAS. The mean compression rate for the first 5 min of data recording was the same in all groups (P = 0.272) and ranged from 104.2 (95% CI of mean: 100.5, 107.8) min -1 to 108.0 (95% CI of mean: 105.1, 108.3) min -1 . The mean compression fraction was also similar across all groups (P = 0.159) and ranged between 74.7% and 78.4%. There was no difference in the compression rates and fractions across the airway management groups, regardless of the duration of CPR.
CONCLUSION
There was no significant difference in the compression fraction associated with the airway management strategy.",2020,The mean compression fraction was also similar across all groups (P = 0.159) and ranged between 74.7% and 78.4%.,['out-of-hospital cardiac arrest'],"['Chest compression fraction (CCF', 'placebo', 'adrenaline vs placebo']","['mean compression rate', 'CPR Quality', 'compression fraction', 'mean compression fraction', 'compression rates and fractions']","[{'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",,0.0676586,The mean compression fraction was also similar across all groups (P = 0.159) and ranged between 74.7% and 78.4%.,"[{'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Deakin', 'Affiliation': 'South Central Ambulance Service NHS Foundation Trust, Otterbourne, SO21 2RU, UK; NIHR Southampton Respiratory Biomedical Research Unit, Southampton, SO16 6YD, UK. Electronic address: charlesdeakin@doctors.org.uk.'}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Nolan', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK; Royal United Hospital, Bath, BA1 3NG, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Rachael T', 'Initials': 'RT', 'LastName': 'Fothergill', 'Affiliation': ""Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK; London Ambulance Service NHS Trust, 8-20 Pocock Street, London, SE1 0BW, UK; Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Quinn', 'Affiliation': ""Kingston University and St George's, University of London, 6th Floor, Hunter Wing, Cranmer Terrace, London, SW17 0RE, UK.""}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Rosser', 'Affiliation': 'West Midlands Ambulance Service University NHS Foundation Trust, Brierley Hill, West Midlands, DY5 1LX, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, CV4 7AL, UK; Heartlands Hospital, University Hospitals Birmingham, Birmingham, B9 5SS, UK.'}]",Resuscitation,['10.1016/j.resuscitation.2020.11.005']
1426,33189807,Sex differences in patients with out-of-hospital cardiac arrest without ST-segment elevation: A COACT trial substudy.,"BACKGROUND
Whether sex is associated with outcomes of out-of-hospital cardiac arrest (OHCA) is unclear.
OBJECTIVES
This study examined sex differences in survival in patients with OHCA without ST-segment elevation myocardial infarction (STEMI).
METHODS
Using data from the randomized controlled Coronary Angiography after Cardiac Arrest (COACT) trial, the primary point of interest was sex differences in OHCA-related one-year survival. Secondary points of interest included the benefit of immediate coronary angiography compared to delayed angiography until after neurologic recovery, angiographic and clinical outcomes.
RESULTS
In total, 522 patients (79.1% men) were included. Overall one-year survival was 59.6% in women and 63.4% in men (HR 1.18; 95% CI: 0.76-1.81;p = 0.47). No cardiovascular risk factors were found that modified survival. Women less often had significant coronary artery disease (CAD) (37.0% vs. 71.3%;p < 0.001), but when present, they had a worse prognosis than women without CAD (HR 3.06; 95% CI 1.31-7.19;p = 0.01). This was not the case for men (HR 1.05; 95% CI 0.67-1.65;p = 0.83). In both sexes, immediate coronary angiography did not improve one-year survival compared to delayed angiography (women, odds ratio (OR) 0.87; 95% CI 0.58-1.30;p = 0.49; vs. men, OR 0.97; 95% CI 0.45-2.09;p = 0.93).
CONCLUSION
In OHCA patients without STEMI, we found no sex differences in overall one-year survival. Women less often had significant CAD, but when CAD was present they had worse survival than women without CAD. This was not the case for men. Both sexes did not benefit from a strategy of immediate coronary angiography as compared to delayed strategy with respect to one-year survival.
CLINICAL TRIAL REGISTRATION NUMBER
Netherlands trial register (NTR) 4973.",2020,"In both sexes, immediate coronary angiography did not improve one-year survival compared to delayed angiography (women, odds ratio (OR) 0.87; 95% CI 0.58-1.30;p = 0.49; vs. men, OR 0.97; 95% CI 0.45-2.09;p = 0.93).
","['patients with out-of-hospital cardiac arrest without ST-segment elevation', '522 patients (79.1% men) were included', 'patients with OHCA without ST-segment elevation myocardial infarction (STEMI']",[],"['cardiovascular risk factors', 'coronary artery disease (CAD', 'Overall one-year survival', 'delayed angiography until after neurologic recovery, angiographic and clinical outcomes', 'overall one-year survival', 'year survival', 'worse survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",[],"[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",522.0,0.547869,"In both sexes, immediate coronary angiography did not improve one-year survival compared to delayed angiography (women, odds ratio (OR) 0.87; 95% CI 0.58-1.30;p = 0.49; vs. men, OR 0.97; 95% CI 0.45-2.09;p = 0.93).
","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Spoormans', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Jorrit S', 'Initials': 'JS', 'LastName': 'Lemkes', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands. Electronic address: j.lemkes@amsterdamumc.nl.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Lucia S D', 'Initials': 'LSD', 'LastName': 'Jewbali', 'Affiliation': 'Thorax Centre, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Dubois', 'Affiliation': 'Thorax Centre, Erasmus Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Data Science, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Department of Cardiology, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Rijpstra', 'Affiliation': 'Department of Intensive care medicine, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Bosker', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Michiel J', 'Initials': 'MJ', 'LastName': 'Blans', 'Affiliation': 'Department of Intensive care medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Gabe B', 'Initials': 'GB', 'LastName': 'Bleeker', 'Affiliation': 'Department of Cardiology, HAGA Hospital, Den Haag, the Netherlands.'}, {'ForeName': 'Remon', 'Initials': 'R', 'LastName': 'Baak', 'Affiliation': 'Department of Intensive care medicine, HAGA Hospital, Den Haag, the Netherlands.'}, {'ForeName': 'Georgios J', 'Initials': 'GJ', 'LastName': 'Vlachojannis', 'Affiliation': 'Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands; Department of Cardiology, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Bob J W', 'Initials': 'BJW', 'LastName': 'Eikemans', 'Affiliation': 'Department of Intensive care medicine, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Pim van', 'Initials': 'PV', 'LastName': 'der Harst', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Cardiology, Groningen, the Netherlands; Department of Cardiology, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Iwan C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Department of Intensive care medicine, Groningen, the Netherlands; Department of Intensive care medicine, Maastricht University Medical Centre, University Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Joris J', 'Initials': 'JJ', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Intensive care medicine, University Medical Centre Utrecht, the Netherlands.'}, {'ForeName': 'Albertus', 'Initials': 'A', 'LastName': 'Beishuizen', 'Affiliation': 'Department of Intensive care medicine, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stoel', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, The Netherlands.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Camaro', 'Affiliation': 'Department of Cardiology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive care medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'José P', 'Initials': 'JP', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P J', 'Initials': 'APJ', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive care medicine, Amsterdam University Medical Centre, location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Vink', 'Affiliation': 'Department of Cardiology, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'van den Bogaard', 'Affiliation': 'Department of Intensive care medicine, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'Ton A C M', 'Initials': 'TACM', 'LastName': 'Heestermans', 'Affiliation': 'Department of Cardiology, Noord West Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'de Ruijter', 'Affiliation': 'Department of Intensive care medicine, Noord West Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'Thijs S R', 'Initials': 'TSR', 'LastName': 'Delnoij', 'Affiliation': 'Department of Intensive care medicine, Maastricht University Medical Centre, University Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Gillian A J', 'Initials': 'GAJ', 'LastName': 'Jessurun', 'Affiliation': 'Department of Cardiology, Scheper Hospital, Emmen, the Netherlands.'}, {'ForeName': 'Pranobe V', 'Initials': 'PV', 'LastName': 'Oemrawsingh', 'Affiliation': 'Department of Cardiology, Haaglanden Medical Centre, Den Haag, the Netherlands.'}, {'ForeName': 'Marcel T M', 'Initials': 'MTM', 'LastName': 'Gosselink', 'Affiliation': 'Department of Cardiology, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'Plomp', 'Affiliation': 'Department of Cardiology, Tergooi Hospital, Blaricum, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Magro', 'Affiliation': 'Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg, the Netherlands.'}, {'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive care medicine, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Appelman', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Centre, location VUmc, Amsterdam, the Netherlands; Department of Cardiology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}]",Resuscitation,['10.1016/j.resuscitation.2020.10.026']
1427,33189951,Memory improvement in aging as a function of exposure to mood-matching music.,"This study examined the effect of matching musical emotion and the mood of the listener on working memory and free recall in normal aging. Memory measures were taken at baseline in healthy young and older participants, and, following a happy or sad mood induction, again after exposure to both mood-matching and -mismatching music in a counterbalanced repeated measures design. Compared to baseline, [i] recall was greater following mood-matching than mood-mismatching music in both groups, and was reduced following mood-mismatching music in older adults, [ii] working memory was greater in the mood-matching condition, but did not differ from baseline in the mismatching condition. The results have significant implications for the increasingly popular forms of intervention involving music used with older populations experiencing cognitive decline.",2020,"Compared to baseline, [i] recall was greater following mood-matching than mood-mismatching music in both groups, and was reduced following mood-mismatching music in older adults, [ii] working memory was greater in the mood-matching condition, but did not differ from baseline in the mismatching condition.","['healthy young and older participants', 'normal aging']",['matching musical emotion'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",[],,0.0577816,"Compared to baseline, [i] recall was greater following mood-matching than mood-mismatching music in both groups, and was reduced following mood-mismatching music in older adults, [ii] working memory was greater in the mood-matching condition, but did not differ from baseline in the mismatching condition.","[{'ForeName': 'Emma V', 'Initials': 'EV', 'LastName': 'Ward', 'Affiliation': 'Middlesex University, London, UK. Electronic address: E.ward@mdx.ac.uk.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Isac', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Donnelly', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Van Puyvelde', 'Affiliation': 'Royal Military Academy, Brussels, Belgium; Vrije Universitei Brussel, Brussels, Belgium.'}, {'ForeName': 'Fabia', 'Initials': 'F', 'LastName': 'Franco', 'Affiliation': 'Middlesex University, London, UK.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103206']
1428,33190032,"Investigation of the effect of the dual orexin receptor antagonist almorexant on ophthalmological, spermatogenic, and hormonal variables in healthy male subjects.","BACKGROUND/AIMS
The aim of this single-center, double-blind study was to investigate the effect of a 4-week once daily administration of 200 mg almorexant on tear film break-up time, spermatogenesis, hormone levels, and pancreatic elastase in stool in healthy male subjects.
METHODS
Almorexant 200 mg or matching placebo was administered in the evening for 4 weeks once daily to 56 healthy male subjects. Changes in ophthalmological variables, sperm composition, hormone levels, and pancreatic elastase levels in stool were evaluated periodically up to 8 weeks after discontinuation of drug administration. Blood samples for pharmacokinetic measurements were taken after 4 weeks to confirm compliance to study drug intake.
RESULTS
The results of this study revealed no treatment effects of almorexant, neither on tear film break-up time nor on other ophthalmological variables investigated during this study. Furthermore, spermatogenesis, hormones of the hypothalamic-pituitary-adrenal and -gonadal axes, and endocrine pancreatic secretion were shown to be not affected by a 4-week once daily administration of almorexant.
CONCLUSION
Almorexant was well tolerated and had no effect on the spectrum of pharmacodynamic variables assessed. Ophthalmology and testicular findings detected in preclinical studies were not observed in this clinical study. Therefore, these preclinical findings appear not to be relevant for humans and do not prevent from conducting larger clinical trials with either healthy subjects or patients.",2020,"The results of this study revealed no treatment effects of almorexant, neither on tear film break-up time nor on other ophthalmological variables investigated during this study.","['56 healthy male subjects', 'healthy male subjects', 'healthy subjects or patients']","['dual orexin receptor antagonist almorexant', '200 mg almorexant', 'Almorexant 200 mg or matching placebo']","['ophthalmological variables, sperm composition, hormone levels, and pancreatic elastase levels', 'Furthermore, spermatogenesis, hormones of the hypothalamic-pituitary-adrenal and -gonadal axes, and endocrine pancreatic secretion', 'ophthalmological, spermatogenic, and hormonal variables', 'tear film break-up time, spermatogenesis, hormone levels, and pancreatic elastase']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4046055', 'cui_str': 'Dual Orexin Receptor Antagonists'}, {'cui': 'C1871407', 'cui_str': 'almorexant'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2013096', 'cui_str': 'OPHTHALMOLOGICALS'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037864', 'cui_str': 'Spermatogenesis'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0018067', 'cui_str': 'Gonadal structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0030296', 'cui_str': 'Pancreatic fluid'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}]",56.0,0.129217,"The results of this study revealed no treatment effects of almorexant, neither on tear film break-up time nor on other ophthalmological variables investigated during this study.","[{'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Clinical Pharmacology, Allschwil Switzerland. Electronic address: jasper.dingemanse@idorsia.com.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Charef', 'Affiliation': 'Idorsia Pharmaceuticals Ltd, Clinical Science, Allschwil, Switzerland.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Stanford Center for Sleep Science and Medicine, Palo Alto, California, United States; Neuropharma, Inc., Park City, Utah, United States.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gouws', 'Affiliation': 'Pasteur Medical Centre, Bloemfontein, South Africa.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110955']
1429,33190085,Patient experiences of as-needed budesonide-formoterol by Turbuhaler® for treatment of mild asthma; a qualitative study.,"BACKGROUND
Combination low-dose budesonide-formoterol, taken as-needed for symptom relief reduces exacerbation risk and is recommended for treatment of mild asthma. The NovelQ qualitative study explored patients' attitudes toward using this novel therapy.
METHODS
Adults with mild asthma using reliever-only treatment were randomised to as-needed budesonide-formoterol Turbuhaler® in a multinational, 52-week open-label randomised controlled trial (NovelSTART-ACTRN12615000999538). A subgroup were interviewed to explore their attitudes to use of as-needed budesonide-formoterol after receiving it for ≥10 months. Semi-structured interviews were conducted until saturation, audio-recorded, and thematically analysed.
RESULTS
Analysis of 35 participants (66% female; mean age 43.5 [range 18-74]; mean Asthma Control Questionnaire score 1.09 ± SD0.55) interviews identified 5 themes, each including both barriers and facilitators to therapy use. Themes were: 'Treatment effectiveness' i.e. how well symptoms were relieved and/or prevented; 'Lifestyle fit of the regimen' e.g. the extent to which the treatment regimen integrated into the patient's daily life; 'Attitudes toward medication use and safety' e.g. openness for new reliever treatments, beliefs about treatment necessity or side effects; 'Device attributes' e.g. perceived ease of use; and 'Doctor-patient relationship' e.g. impact of health professional support on new treatment acceptance.
CONCLUSIONS
A wide range of factors seem to drive the opinions of mild asthma patients on as-needed budesonide-formoterol therapy. Many patients perceived both positive and negative treatment attributes, and their individual evaluation of these attributes determined their likelihood of using it after the study. Supportive patient-physician interactions appear key to addressing patient barriers. Recommendations for patient-centred discussions, developed from this research, are provided.",2020,"Many patients perceived both positive and negative treatment attributes, and their individual evaluation of these attributes determined their likelihood of using it after the study.","['mild asthma', '35 participants (66% female; mean age 43.5 [range 18-74', 'Adults with mild asthma using reliever-only treatment']","['budesonide-formoterol', 'budesonide-formoterol Turbuhaler®', 'budesonide-formoterol by Turbuhaler®']",['mean Asthma Control Questionnaire score'],"[{'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4706265', 'cui_str': 'Asthma Control Questionnaire score'}]",,0.0311362,"Many patients perceived both positive and negative treatment attributes, and their individual evaluation of these attributes determined their likelihood of using it after the study.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Foster', 'Affiliation': 'Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia. Electronic address: j.m.foster@woolcock.org.au.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: richard.beasley@mrinz.ac.nz.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Braithwaite', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: Irene.Braithwaite@mrinz.ac.nz.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Harrison', 'Affiliation': 'Nottingham Respiratory Medicine Unit and NIHR Biomedical Research Centre, University of Nottingham, Nottingham, UK. Electronic address: tim.harrison@nottingham.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. Electronic address: Mark.Holliday@mrinz.ac.nz.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Pavord', 'Affiliation': 'Respiratory Medicine Unit, Oxford Respiratory NIHR Biomedical Research Centre, University of Oxford, Oxford, UK. Electronic address: ian.pavord@ndm.ox.ac.uk.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia. Electronic address: helen.reddel@sydney.edu.au.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106154']
1430,33148502,Respiratory sinus arrhythmia biofeedback alters heart rate variability and default mode network connectivity in major depressive disorder: A preliminary study.,"Traditional major depressive disorder (MDD) interventions do not improve heart rate variability (HRV), despite symptom reduction. We investigated whether respiratory sinus arrhythmia (RSA)-biofeedback (BFB) effectively changed HRV, psychological symptoms, and functional connectivity of the default mode network (DMN), which is known to increase in MDD. Thirty MDD patients were randomly assigned to two groups (RSA-BFB with treatment as usual [TAU] with medication [BFB + TAU; n = 16] and TAU [n = 14]). Six RSA-BFB sessions were performed over 4 weeks. We assessed psychological symptoms (including depression, anxiety, and hopelessness), high frequency (HF; an index of HRV during rest and stress), and DMN functional connectivity, as measured by source-level coherence of 19-channel electroencephalography using standardized weighted low-resolution brain electromagnetic tomography. Large-scale DMN was represented by small-worldness based on graph theory. The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group. Significant group by session interactions were found in resting HF-HRV, stress-reactive HF-HRV, and beta DMN small-worldness. During the post-intervention session, the BFB + TAU group showed higher resting HF-HRV and stress-reactive HF-HRV (d = 1.41 for the resting stage and d = 1.99 for the Stroop test, P < .005). Compared to baseline, the BFB + TAU group showed increased HF-HRV reactivity and decreased DMN small-worldness in the beta band, implying decreased global DMN functional connectivity. Conversely, the TAU group showed decreased HF-HRV during stress and no DMN alterations. This study was limited by small sample size and open-label design. These preliminary findings suggest that brief RSA-BFB may improve autonomic nervous system and DMN functions in MDD.",2020,The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group.,"['Thirty MDD patients', 'major depressive disorder']","['RSA-BFB', 'RSA-BFB with treatment as usual [TAU] with medication [BFB\xa0+\xa0TAU; n\xa0=\xa016] and TAU', 'TAU', 'respiratory sinus arrhythmia (RSA)-biofeedback (BFB']","['HF-HRV reactivity', 'resting HF-HRV, stress-reactive HF-HRV, and beta DMN small-worldness', 'heart rate variability (HRV', 'psychological symptoms (including depression, anxiety, and hopelessness), high frequency (HF; an index of HRV during rest and stress), and DMN functional connectivity, as measured by source-level coherence of 19-channel electroencephalography', 'global DMN functional connectivity', 'HF-HRV', 'resting HF-HRV and stress-reactive HF-HRV', 'depression (especially psychic anxiety and vegetative symptoms']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",30.0,0.0595873,The BFB + TAU group showed greater reductions in depression (especially psychic anxiety and vegetative symptoms) compared to the TAU group.,"[{'ForeName': 'Su Mi', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; Department of Clinical Medical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Yeon', 'Initials': 'HY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea; Department of Clinical Medical Sciences, Seoul National University College of Medicine, Seoul, Republic of Korea; Department of Psychiatry and Behavioral Science and Institute of Human Behavioral Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: hyjung@snu.ac.kr.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.10.008']
1431,33151802,Do knee injection portals affect clinical results of bone marrow aspirate concentrate injection in the treatment of osteoarthritis? A prospective randomized controlled study.,"Aim: To explore the effect that the location of needle placement has on efficacy and tolerability of bone marrow aspirate concentrate injections during treatment of knee osteoarthritis. Methods: Bone marrow aspirate concentrate injections were administered to 111 patients via superolateral, anteromedial or anterolateral portals. Pain was assessed by visual analog scale before and 3, 7, 14 and 21 days after intervention. Knee function was assessed by Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee scores before and 1, 3, 6, 9 and 12 months after intervention. Results: Significant differences in Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee scores were observed 12 months post intervention compared with baseline (p < 0.001 for all comparisons). No significant differences in outcome or pain scores were observed among groups. Conclusion: All portals demonstrated similar clinical benefits up to 12 months after intervention. Trial registration number: ClinicalTrials.gov (NCT03825133).",2020,No significant differences in outcome or pain scores were observed among groups. ,"['111 patients via superolateral, anteromedial or anterolateral portals']","['Bone marrow aspirate concentrate injections', 'needle placement', 'bone marrow aspirate concentrate injections']","['visual analog scale', 'scores', 'outcome or pain scores', 'Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee scores', 'Knee function', 'Pain', 'efficacy and tolerability', 'Western Ontario and McMaster Universities Osteoarthritis Index, Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0205054', 'cui_str': 'Portal'}]","[{'cui': 'C0857285', 'cui_str': 'Bone marrow aspirate'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",111.0,0.17973,No significant differences in outcome or pain scores were observed among groups. ,"[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Dulic', 'Affiliation': 'University of Novi Sad, Medical Faculty, Clinical Center of Vojvodina, Department for Orthopedic Surgery & Traumatology, Hajduk Veljkova 1-9, Novi Sad, Serbia.'}, {'ForeName': 'Ivica', 'Initials': 'I', 'LastName': 'Lalic', 'Affiliation': 'University of Novi Sad, Medical Faculty, Clinical Center of Vojvodina, Department for Orthopedic Surgery & Traumatology, Hajduk Veljkova 1-9, Novi Sad, Serbia.'}, {'ForeName': 'Vaso', 'Initials': 'V', 'LastName': 'Kecojevic', 'Affiliation': 'University of Novi Sad, Medical Faculty, Clinical Center of Vojvodina, Department for Orthopedic Surgery & Traumatology, Hajduk Veljkova 1-9, Novi Sad, Serbia.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Gavrilovic', 'Affiliation': 'Atlas Hospital,\xa0Osmana Djikica 5, Belgrade, Serbia.'}, {'ForeName': 'Dzihan', 'Initials': 'D', 'LastName': 'Abazovic', 'Affiliation': 'Renova Hospital,\xa0Osmana Djikica 5, Belgrade, Serbia.'}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Miskulin', 'Affiliation': 'Specijalna bolnica za Neurokirurgiju i ortopediju Aksis, Zagreb, Petrovaradinska\xa01, 10000 ZAGREB, Croatia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Maric', 'Affiliation': 'MD Orto Hospital, Futoski put 115, Novi Sad, Serbia.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Bumbasirevic', 'Affiliation': 'University of Belgrade, Medical Faculty, Clinical Center of Serbia, Clinic for Orthopedic Surgery & Traumatology, Dr. Subotica 20, Belgrade, Serbia.'}]",Regenerative medicine,['10.2217/rme-2020-0020']
1432,33152522,Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain.,"BACKGROUND
The patient acceptable symptom state (PASS) is a treatment-response criterion developed to determine the clinical relevance of a treatment effect. Its estimates for some patient-reported outcomes (PROs) in non-specific chronic low back pain (cLBP) are lacking and the stability of PRO estimates between independent cLBP populations is unknown. We hypothesized that these PRO estimates will be stable.
OBJECTIVES
To estimate and compare the PASS for PROs between 2 independent cLBP populations.
METHODS
We conducted a secondary analysis of a randomized controlled trial (PREDID) and a cohort of outpatients with non-specific cLBP. Using an anchoring question, participants who self-rated their health as ""excellent"", ""very good"" or ""good"" at 1 month were considered to have an acceptable symptom state. PASS estimates for 5 PROs were calculated by using the 75th percentile method. Estimates were compared between the 2 populations with bootstrap resampling.
RESULTS
A total of 256 participants with non-specific cLBP were included: 135 patients with cLBP and active discopathy from the PREDID trial and 121 outpatients with cLBP without active discopathy followed up in an independent cohort. Overall, 137/256 (54%) participants had an acceptable symptom state at 1 month. PASS estimates were 47.5 (95% confidence interval [CI] 40.0 to 50.0)/100 for lumbar pain (0, no pain and 100, maximal pain), 30.5 (30.0 to 40.0)/100 for radicular pain, 39.3 (33.6 to 45.3)/100 for Quebec Back Pain Disability score (0, no disability and 100, maximal disability), 10.0 (9.2 to 10.0)/21 for the Hospital Anxiety Depression anxiety subscale (0, no anxiety, and 21, maximal anxiety) and 6.7 (6.0 to 8.0)/21 for the depression subscale (0, no depression, and 21, maximal depression). PASS estimates did not differ between the 2 populations.
CONCLUSIONS
Our study provides PASS estimates for 5 PROs commonly used in cLBP. Our estimates were stable between 2 independent populations of people with cLBP. The stability of our PASS estimates suggests that they are relevant for interpreting PRO values in clinical trials and practice. ClinicalTrials.gov no. (PREDID trial) NCT00804531.",2020,"PASS estimates did not differ between the 2 populations.
","['people with non-specific chronic low back pain', 'outpatients with non-specific cLBP', '256 participants with non-specific cLBP were included: 135 patients with cLBP and active discopathy from the PREDID trial and 121 outpatients with cLBP without active discopathy followed up in an independent cohort']",[],"['acceptable symptom state', 'Hospital Anxiety Depression anxiety subscale (0, no anxiety, and 21, maximal anxiety', 'Quebec Back Pain Disability score', 'PASS estimates', 'lumbar pain (0, no pain and 100, maximal pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2747858', 'cui_str': 'Discopathy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",256.0,0.166062,"PASS estimates did not differ between the 2 populations.
","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Daste', 'Affiliation': ""Université de Paris, faculté de santé, UFR de médecine de Paris-Centre, 75006 Paris, France; Hôpital Cochin, service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, centre-université de Paris, AP-HP, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMR-S 1153, centre de recherche épidémiologie et statistique Paris (CRESS), ECaMO Team, 75004 Paris, France.""}, {'ForeName': 'Hendy', 'Initials': 'H', 'LastName': 'Abdoul', 'Affiliation': ""Unité de recherche clinique-centre d'investigation clinique Paris-Descartes-Necker/Cochin, hôpital Tarnier, 75006 Paris, France.""}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': ""Unité de recherche clinique-centre d'investigation clinique Paris-Descartes-Necker/Cochin, hôpital Tarnier, 75006 Paris, France; EA 7323, évaluation des thérapeutiques et pharmacologie périnatale et pédiatrique, 75006 Paris, France.""}, {'ForeName': 'Marie-Martine', 'Initials': 'MM', 'LastName': 'Lefèvre-Colau', 'Affiliation': ""Université de Paris, faculté de santé, UFR de médecine de Paris-Centre, 75006 Paris, France; Hôpital Cochin, service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, centre-université de Paris, AP-HP, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMR-S 1153, centre de recherche épidémiologie et statistique Paris (CRESS), ECaMO Team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': ""Université de Paris, faculté de santé, UFR de médecine de Paris-Centre, 75006 Paris, France; Hôpital Cochin, service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, centre-université de Paris, AP-HP, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMR-S 1153, centre de recherche épidémiologie et statistique Paris (CRESS), ECaMO Team, 75004 Paris, France; Institut fédératif de recherche sur le handicap, 75013 Paris, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Rannou', 'Affiliation': ""Université de Paris, faculté de santé, UFR de médecine de Paris-Centre, 75006 Paris, France; Hôpital Cochin, service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, centre-université de Paris, AP-HP, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMR-S 1124, toxicité environnementale, cibles thérapeutiques, signalisation cellulaire et biomarqueurs (T3S), campus Saint-Germain-des-Prés, 75006 Paris, France.""}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'Nguyen', 'Affiliation': ""Université de Paris, faculté de santé, UFR de médecine de Paris-Centre, 75006 Paris, France; Hôpital Cochin, service de rééducation et de réadaptation de l'appareil locomoteur et des pathologies du Rachis, centre-université de Paris, AP-HP, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France; INSERM UMR-S 1124, toxicité environnementale, cibles thérapeutiques, signalisation cellulaire et biomarqueurs (T3S), campus Saint-Germain-des-Prés, 75006 Paris, France. Electronic address: christelle.nguyen2@aphp.fr.""}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.10.005']
1433,33152609,Effects of a 10-week running-retraining programme on the foot strike pattern of adolescents: A longitudinal intervention study.,"BACKGROUND
The purpose of this study was to analyse the effects of ten weeks of different running-retraining programmes on rearfoot strike (RFS) prevalence in adolescents.
RESEARCH QUESTION
it is possible to change foot strike pattern in adolescents?
METHODS
A total of 180 children (45.3% girls), aged 13-16 years, participated in this intervention study. The children were randomly assigned to one of three experimental groups (EGs) that each carried out a different retraining programme, based on running technique (n = 39), a 15% increased step frequency (SF) (n = 37) and barefoot training (n = 30), performed for three days each week. A control group (CG) (n = 43) did not perform any retraining. A 2D video-based analysis (240 Hz) was used to determine the RFS.
RESULTS
At baseline, no significant differences in RFS prevalence were found between the EGs and the CG in either the left (χ 2 = 2.048; p = 0.559) or the right foot (χ 2 = 0.898; p = 0.825). In the post-test, no significant differences were found for the left foot (χ 2 = 7.102; p = 0.069), but there were significant differences for the right foot (χ 2 = 9.239; p = 0.025) were observed. In the re-test, no significant differences were found for either the left foot (χ 2 = 2.665; p = 0.273) or the right foot (χ 2 = 2.182; p = 0.325). In addition, no group displayed significant changes in RFS prevalence from the pre-test to the re-test. There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
MEANING
The main finding of this study was that certain running-retraining programmes performed three times per week for ten weeks are not enough to modify the adolescent foot strike pattern (FSP).",2020,"There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
","['adolescents', '180 children (45.3% girls), aged 13-16 years']","['running-retraining programmes', '10-week running-retraining programme', 'barefoot training']","['RFS prevalence', 'rearfoot strike (RFS) prevalence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0038452', 'cui_str': 'Employee Strikes'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",180.0,0.0205722,"There was a trend towards a reduction in the RFS prevalence in both the increased SF group and the barefoot group.
","[{'ForeName': 'Pedro José', 'Initials': 'PJ', 'LastName': 'Consuegra González', 'Affiliation': 'University of Jaen, Spain. C/Sacramento, 7 Úbeda (Jaén), Spain. Electronic address: consuegragonzalezpj@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'García-Pinillos', 'Affiliation': 'Department of Physical Education and Sport, University of Granada, Spain; Department of Physical Education, Sports and Recreation. Universidad de La Frontera, Temuco, Chile. Electronic address: fegarpi@gmail.com.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mora López', 'Affiliation': 'I.E.S. Cañada de las Fuentes, Spain.'}, {'ForeName': 'Antonio José', 'Initials': 'AJ', 'LastName': 'Cardona Linares', 'Affiliation': 'University Pablo De Olavide of Seville, Spain. Electronic address: ajcarlin@upo.es.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Párraga Montilla', 'Affiliation': 'University of Jaen, Spain. Electronic address: jparraga@ujaen.es.'}, {'ForeName': 'Pedro Ángel', 'Initials': 'PÁ', 'LastName': 'Latorre-Román', 'Affiliation': 'University of Jaen, Spain. Electronic address: platorre@ujaen.es.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.024']
1434,33152672,"Health economic design for cost, cost-effectiveness and simulation analyses in the HEALing Communities Study.","BACKGROUND
The HEALing Communities Study (HCS) is designed to implement and evaluate the Communities That HEAL (CTH) intervention, a conceptually driven framework to assist communities in selecting and adopting evidence-based practices to reduce opioid overdose deaths. The goal of the HCS is to produce generalizable information for policy makers and community stakeholders seeking to implement CTH or a similar community intervention. To support this objective, one aim of the HCS is a health economics study (HES), the results of which will inform decisions around fiscal feasibility and sustainability relevant to other community settings.
METHODS
The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio. The objectives of the HES are to estimate the economic costs to communities of implementing and sustaining CTH; estimate broader societal costs associated with CTH; estimate the cost-effectiveness of CTH for overdose deaths avoided; and use simulation modeling to evaluate the short- and long-term health and economic impact of CTH, including future overdose deaths avoided and quality-adjusted life years saved, and to develop a simulation policy tool for communities that seek to implement CTH or a similar community intervention.
DISCUSSION
The HCS offers an unprecedented opportunity to conduct health economics research on solutions to the opioid crisis and to increase understanding of the impact and value of complex, community-level interventions.",2020,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","['67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio']","['CTH intervention', 'HCS', 'HEAL (CTH) intervention', 'CTH']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],,0.0271047,"The HES is integrated into the HCS design: an unblinded, multisite, parallel arm, cluster randomized, wait list-controlled trial of the CTH intervention implemented in 67 communities in four U.S. states: Kentucky, Massachusetts, New York, and Ohio.","[{'ForeName': 'Arnie P', 'Initials': 'AP', 'LastName': 'Aldridge', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States. Electronic address: aaldridge@rti.org.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Barbosa', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Barocas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, College of Public Health, 111 Washington Ave., Lexington, KY, 40536, United States.'}, {'ForeName': 'Jagpreet', 'Initials': 'J', 'LastName': 'Chhatwal', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, Boston, MA, 02114, United States.'}, {'ForeName': 'Kristin J', 'Initials': 'KJ', 'LastName': 'Harlow', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Ayaz', 'Initials': 'A', 'LastName': 'Hyder', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Linas', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'University of Miami Miller School of Medicine, 1120 NW 14(th)Street, Suite 1019, Miami, FL, 33136, United States.'}, {'ForeName': 'Jake R', 'Initials': 'JR', 'LastName': 'Morgan', 'Affiliation': 'Boston University School of Public Health, 715 Albany St, Boston, MA, 02118, United States.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Savitzky', 'Affiliation': 'Boston Medical Center, One Boston Medical Center Pl, Boston, MA, 02118, United States.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Weill Cornell Medicine, 425 East 61(st)Street, Suite 301, New York, NY, 10065, United States.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Seiber', 'Affiliation': 'The Ohio State University College of Public Health, 250 Cunz Hall, 1841 Neil Ave., Columbus, OH, 43210, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'E Starbird', 'Affiliation': 'Columbia University, New York, NY, 10027, United States; University of Pennsylvania School of Nursing, 418 Curie Blvd, Philadelphia, PA, 19104, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Villani', 'Affiliation': 'National Institute on Drug Abuse, 3WFN RM08A45, MSC 6025, 301 North Stonestreet Ave, Rockville, MD, 20852, United States.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI International, 3040 East Cornwallis Road, RTP, NC, 27709, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108336']
1435,33157007,"An RCT of Rapid Genomic Sequencing among Seriously Ill Infants Results in High Clinical Utility, Changes in Management, and Low Perceived Harm.","The second Newborn Sequencing in Genomic Medicine and Public Health (NSIGHT2) study was a randomized, controlled trial of rapid whole-genome sequencing (rWGS) or rapid whole-exome sequencing (rWES) in infants with diseases of unknown etiology in intensive care units (ICUs). Gravely ill infants were not randomized and received ultra-rapid whole-genome sequencing (urWGS). Herein we report results of clinician surveys of the clinical utility of rapid genomic sequencing (RGS). The primary end-point-clinician perception that RGS was useful- was met for 154 (77%) of 201 infants. Both positive and negative tests were rated as having clinical utility (42 of 45 [93%] and 112 of 156 [72%], respectively). Physicians reported that RGS changed clinical management in 57 (28%) infants, particularly in those receiving urWGS (p = 0.0001) and positive tests (p < 0.00001). Outcomes of 32 (15%) infants were perceived to be changed by RGS. Positive tests changed outcomes more frequently than negative tests (p < 0.00001). In logistic regression models, the likelihood that RGS was perceived as useful increased 6.7-fold when associated with changes in management (95% CI 1.8-43.3). Changes in management were 10.1-fold more likely when results were positive (95% CI 4.7-22.4) and turnaround time was shorter (odds ratio 0.92, 95% CI 0.85-0.99). RGS seldom led to clinician-perceived confusion or distress among families (6 of 207 [3%]). In summary, clinicians perceived high clinical utility and low likelihood of harm with first-tier RGS of infants in ICUs with diseases of unknown etiology. RGS was perceived as beneficial irrespective of whether results were positive or negative.",2020,"Both positive and negative tests were rated as having clinical utility (42 of 45 [93%] and 112 of 156 [72%], respectively).","['Gravely ill infants', 'infants with diseases of unknown etiology in intensive care units (ICUs']","['rapid whole-genome sequencing (rWGS) or rapid whole-exome sequencing (rWES', 'rapid genomic sequencing (RGS', 'ultra-rapid whole-genome sequencing (urWGS']","['turnaround time', 'RGS changed clinical management']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C3640076', 'cui_str': 'Whole genome sequencing'}, {'cui': 'C3640077', 'cui_str': 'Complete Exome Sequencing'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",,0.111788,"Both positive and negative tests were rated as having clinical utility (42 of 45 [93%] and 112 of 156 [72%], respectively).","[{'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dimmock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA. Electronic address: ddimmock@rchsd.org.""}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Gaughran', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Cakici', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA; Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Caylor', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Clarke', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Feddock', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Shimul', 'Initials': 'S', 'LastName': 'Chowdhury', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Salz', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Cheung', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Department of Psychiatry, University of California San Diego, San Diego, CA 92093, USA.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Bird', 'Affiliation': ""Rady Children's Hospital, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hobbs', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Wigby', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA; Department of Pediatrics, University of California San Diego, San Diego, CA 92093, USA.""}, {'ForeName': 'Lauge', 'Initials': 'L', 'LastName': 'Farnaes', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': 'Cinnamon S', 'Initials': 'CS', 'LastName': 'Bloss', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA 92093, USA; Department of Psychiatry, University of California San Diego, San Diego, CA 92093, USA.'}, {'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Kingsmore', 'Affiliation': ""Rady Children's Institute for Genomic Medicine, San Diego, CA 92123, USA; Rady Children's Hospital, San Diego, CA 92123, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of human genetics,['10.1016/j.ajhg.2020.10.003']
1436,33157152,Intranasal oxytocin attenuates insula activity in response to dynamic angry faces.,"The effects of intranasal oxytocin on amygdala activity during emotional perception are often mixed. Given that the brain is organized into networks of interconnected areas, functional connectivity might provide an effective way to further understand the oxytocin effect. The aim of the present study was to investigate whether oxytocin administration affects amygdala activity and its functional connectivity during dynamic facial expression perception. Using a between-group, double-blind, placebo-controlled design, 55 participants were randomly assigned to groups receiving a single dose of 24 IU oxytocin or a placebo via intranasal administration. An implicit emotional task was employed to investigate the effect of oxytocin on neural responses to dynamic angry, neutral, and happy facial expressions with fMRI. Participants were instructed to respond only when the inverted dynamic faces were presented. The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces. However, functional connectivity between the regions involved in the perception of dynamic angry faces was not changed following oxytocin administration. The present findings may contribute to our understanding of the anxiolytic effects of oxytocin and eventually facilitate human clinical applications.",2020,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.",['55 participants'],"['placebo', 'intranasal oxytocin', 'oxytocin', 'Intranasal oxytocin']","['neural responses to dynamic angry, neutral, and happy facial expressions with fMRI', 'activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG', 'amygdala activity']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0175754', 'cui_str': 'Agenesis of corpus callosum'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",55.0,0.160768,"The results indicated that oxytocin attenuated activation of insula and emotional processing-related regions (e.g., ACC, thalamus, and MFG) during the viewing of dynamic angry faces.","[{'ForeName': 'Yuanxiao', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China; School of Psychology, Nanjing Normal University, Nanjing, 210024, China.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Ran', 'Affiliation': 'Institute of Education, China West Normal University, Nanchong, 637002, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Hu', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, 200062, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Wenshuang', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Cognition and Personality of Ministry of Education, Faculty of Psychology, Southwest University, Chongqing, 400715, China. Electronic address: chenxu@swu.edu.cn.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107976']
1437,33159336,Efficacy of a self-help parenting intervention for parents of children with attention deficit hyperactivity disorder in adjunct to usual treatment-Small-scale randomized controlled trial.,"BACKGROUND
Multimodal intervention incorporating psychosocial intervention and medication is recommended for school-aged children with attention deficit hyperactivity disorder (ADHD). This randomized controlled trial (RCT) investigates the adjunctive benefit of the self-help version of the New Forest Parenting Programme (NFPP-SH) when offered in addition to treatment as usual (TAU) compared with TAU alone.
METHOD
Fifty-two children, receiving medication for ADHD as part of their usual care, were randomized to receive NFPP-SH + TAU or TAU alone.
RESULTS
When used in adjunct to TAU, NFPP-SH may have beneficial effects for parenting efficacy (F = 6.28, p = 0.02), child social performance in school and negative comments made by parents during a recorded speech sample. However, the self-help intervention did not have any additional effect on child behaviour.
CONCLUSIONS
This study provides further support for self-help interventions as potentially low-intensity and cost-effective alternatives to therapist-led parenting interventions. The findings require replication in larger samples before any firm conclusions about adjunctive efficacy of NFPP-SH can be drawn but underline the potential for self-help within routine treatment (ClinicalTrials.gov Identifier: NCT02174952).",2020,"When used in adjunct to TAU, NFPP-SH may have beneficial effects for parenting efficacy (F=6.28, p=0.02), child social performance in school and negative comments made by parents during a recorded speech sample.","['parents of children with Attention Deficit Hyperactivity Disorder', 'school aged children with Attention-Deficit/Hyperactivity Disorder (ADHD', 'Fifty-two children, receiving medication for ADHD as part of their usual care']","['New Forest Parenting Programme (NFPP-SH', 'NFPP-SH+TAU or TAU alone', 'TAU, NFPP-SH', 'self-help parenting intervention', 'Multimodal intervention incorporating psychosocial intervention and medication', 'NFPP-SH']",['child social performance'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}]",52.0,0.0879108,"When used in adjunct to TAU, NFPP-SH may have beneficial effects for parenting efficacy (F=6.28, p=0.02), child social performance in school and negative comments made by parents during a recorded speech sample.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Daley', 'Affiliation': 'Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Tarver', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Kapil', 'Initials': 'K', 'LastName': 'Sayal', 'Affiliation': 'Division of Psychiatry and Applied Psychology, School of Medicine, University of Nottingham, Nottingham, UK.'}]","Child: care, health and development",['10.1111/cch.12825']
1438,33164281,Effects of running exercises on reaction time and working memory in individuals with intellectual disability.,"BACKGROUND
This study explored the effect of running exercises at low [30% heart rate reserve (HRR)] and moderate (60%HRR) intensities on cognitive performances in individuals with intellectual disability (ID).
METHODS
Participants performed randomly reaction time (RT) tests: visual RT [simple RT (SRT) and choice RT (CRT)], auditory SRT (ASRT) and working memory (WM) (Corsi test) before and after the exercises.
RESULTS
The results showed that after both exercises, SRT decreased significantly (P < 0.001) in both groups with higher extent (P < 0.05) at 60%HRR compared with 30%HRR. CRT decreased (P < 0.01), similarly, after the both exercises in both groups with higher (P < 0.001) extent in the intellectual disability group (IDG). ASRT decreased significantly, at 30%HRR, in IDG (P < 0.001) and in control group (CG) (P < 0.01) with greater extent in IDG (P < 0.001). At 60%HRR, ASRT decreased significantly in both groups (P < 0.001) with greater extent in IDG (P < 0.001). The ΔASRT% was significantly (P < 0.05) higher at 30%HRR compared with 60%HRR in IDG. In CG, no significant (P = 0.21) difference was reported between intensities. The Corsi forward and the Corsi backward scores increased significantly (P < 0.01) in both groups after both intensities with higher extent in IDG (P < 0.01).
CONCLUSIONS
Our results suggest that low and moderate running exercises improve similarly simple and choice visual RT as well as WM in individuals with ID. Furthermore, low-intensity exercise could be more appropriate to enhance ASRT compared the moderate one in these individuals. Therefore, low-intensity exercise seems to be an efficient strategy to improve cognitive performances in individuals with ID.",2021,"The results showed that after both exercises, SRT decreased significantly (P < 0.001) in both groups with higher extent (P < 0.05) at 60%HRR compared with 30%HRR.","['Participants performed', 'individuals with intellectual disability', 'individuals with ID', 'individuals with intellectual disability (ID']","['randomly reaction time (RT) tests: visual RT [simple RT (SRT) and choice RT (CRT', 'running exercises', 'low and moderate running exercises']","['CRT', 'cognitive performances', 'heart rate reserve (HRR)] and moderate (60%HRR) intensities on cognitive performances', 'SRT', 'ASRT', 'auditory SRT (ASRT) and working memory (WM) (Corsi test', 'reaction time and working memory', 'Corsi forward and the Corsi backward scores']","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0035953', 'cui_str': 'Running'}]","[{'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0333174,"The results showed that after both exercises, SRT decreased significantly (P < 0.001) in both groups with higher extent (P < 0.05) at 60%HRR compared with 30%HRR.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Affes', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borji', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zarrouk', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sahli', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'Research Laboratory: Education, Motricité, Sport et Santé, EM2S, LR19JS01, High Institute of Sport and Physical Education of Sfax, University of Sfax, Sfax, Tunisia.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12798']
1439,33165938,Eptinezumab Demonstrated Efficacy in Sustained Prevention of Episodic and Chronic Migraine Beginning on Day 1 After Dosing.,"OBJECTIVE
To determine the onset of preventive efficacy with eptinezumab in patients with migraine.
BACKGROUND
Eptinezumab is a monoclonal antibody inhibiting calcitonin gene-related peptide approved as an intravenously administered treatment for the prevention of migraine.
METHODS
Patients who received eptinezumab 100 mg, eptinezumab 300 mg, or placebo in PROMISE7-1 (episodic migraine; 100 mg, n = 221; 300 mg, n = 222; placebo, n = 222) or PROMISE7-2 (chronic migraine; 100 mg, n = 356; 300 mg, n = 350; placebo, n = 366) were included. Testing of the percentage of patients with a migraine on day 1 after dosing was prespecified and alpha-controlled. In further exploration of this prespecified endpoint, a post hoc closed testing procedure, which controlled the false-positive (type 1) error rate, provided a statistically rigorous evaluation of migraine prevention onset. The procedure involved up to 84 tests of significance, all of which were performed in sequence until the first nonsignificant result.
RESULTS
For both studies, all tests for significance for eptinezumab 100 and 300 mg, from days 1-84 through day 1 alone, achieved nominal significance (P < .05), indicating that eptinezumab was fully effective beginning on day 1. Over each interval, the treatment effect was comparable to the effect over weeks 1-12. Mean changes from baseline in monthly migraine days for the primary endpoint period ranged from -3.9 to -4.9, -4.1 to -4.9, and -2.2 to -3.2 for eptinezumab 100, 300 mg, and placebo, respectively, in PROMISE7-1 and from -7.2 to -8.0, -7.9 to -8.2, and -4.3 to -5.6, respectively, in PROMISE7-2. The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE7-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE7-2.
CONCLUSIONS
The migraine preventive effect of eptinezumab is rapid and sustained in patients with episodic or chronic migraine, with onset of optimal preventive efficacy observed on the day following the initial dose.",2020,"The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE-2.
","['Patients who received', 'patients with migraine', 'patients with episodic or chronic migraine']","['placebo', 'eptinezumab 100\xa0mg, eptinezumab 300\xa0mg, or placebo in PROMISE-1 (episodic migraine; 100\xa0mg, n\xa0=\xa0221; 300\xa0mg, n\xa0=\xa0222; placebo, n\xa0=\xa0222) or PROMISE-2 (chronic migraine; 100\xa0mg, n\xa0=\xa0356; 300\xa0mg, n\xa0=\xa0350; placebo', 'eptinezumab']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517735', 'cui_str': '350'}]",[],366.0,0.120811,"The difference from placebo (95% confidence interval) in day 1 treatment effect was -2.2 (-4.1, -0.3) and -2.5 (-4.4, -0.6) days/month for eptinezumab 100 and 300 mg, respectively, in PROMISE-1, and was -3.8 (-5.6, -2.0) and -4.0 (-5.8, -2.1) days/month for 100 and 300 mg, respectively, in PROMISE-2.
","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic Arizona, Mayo Clinic Arizona, Scottsdale, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gottschalk', 'Affiliation': 'Yale Neurology, New Haven, CT, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting, Inc., Woodinville, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Snapinn', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals, Inc., Bothell, WA, USA.'}]",Headache,['10.1111/head.14007']
1440,33172866,Saline-Lock Versus Continuous Infusion: Maintaining Peripheral Intravenous Catheter Access in Children.,"OBJECTIVES
In children, peripheral intravenous catheters (PIVs) are maintained by either a continuous infusion of fluid ""to keep vein open"" (TKO) or a saline lock (SL). There is a widespread perception that TKO prolongs PIV patency, but there is a lack of evidence for this. We hypothesized that there would be no significant difference in duration of PIV patency between TKO and SL.
PATIENTS AND METHODS
This prospective, time-allocated study included patients from newborn to 17 years of age admitted to our pediatric ward. Patients enrolled in the first 3 months were assigned to TKO, and patients in the latter 3 months were assigned to SL. Primary outcome was duration of functional patency of the first PIV during the time of TKO or SL. Secondary outcomes included PIV-related complications and patient and caregiver satisfaction.
RESULTS
Complete PIV data were available on 172 ( n = 85 TKO, n = 87 SL) of 194 enrolled patients. The mean (SD) duration of PIV patency was 41.68 (41.71) hours in the TKO group and 44.05 (41.46) hours in the SL group, which was not significantly different ( P = .71). There were no significant differences in complication rates or overall patient and caregiver satisfaction. One patient in the TKO group had their PIV removed because of risk of strangulation from tubing.
CONCLUSION
There were no significant differences between TKO and SL in the duration of PIV patency, complication rates, and overall patient and caregiver satisfaction in our pediatric population. Overall, SL is a safe and reasonable alternative to TKO in maintaining PIV patency in children.",2020,"There were no significant differences between TKO and SL in the duration of PIV patency, complication rates, and overall patient and caregiver satisfaction in our pediatric population.","['children', 'patients from newborn to 17 years of age admitted to our pediatric ward', '194 enrolled patients', 'Children']","['fluid ""to keep vein open"" (TKO) or a saline lock (SL', 'SL', 'TKO', 'Saline-Lock Versus Continuous Infusion']","['mean (SD) duration of PIV patency', 'duration of functional patency of the first PIV during the time of TKO or SL', 'duration of PIV patency, complication rates, and overall patient and caregiver satisfaction', 'PIV-related complications and patient and caregiver satisfaction', 'duration of PIV patency', 'complication rates or overall patient and caregiver satisfaction']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1608324', 'cui_str': 'Catheter injection port'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1608324', 'cui_str': 'Catheter injection port'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1319173', 'cui_str': 'Caregiver wellbeing status'}]",194.0,0.0699211,"There were no significant differences between TKO and SL in the duration of PIV patency, complication rates, and overall patient and caregiver satisfaction in our pediatric population.","[{'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Yeung', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Miller', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Ojha', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'McKelvie', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Dirk E', 'Initials': 'DE', 'LastName': 'Bock', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Saoirse', 'Initials': 'S', 'LastName': 'Cameron', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Taheri', 'Affiliation': ""Department of Pediatrics, Children's Hospital, London Health Sciences Centre, London, Ontario; sepideh.taheri@lhsc.on.ca.""}]",Hospital pediatrics,['10.1542/hpeds.2020-0137']
1441,33171431,Expressive writing to combat distress associated with the COVID-19 pandemic in people with inflammatory bowel disease (WriteForIBD): A trial protocol.,"OBJECTIVE
A large proportion of patients with inflammatory bowel disease (IBD) receive immunosuppressive medication, may be at higher risk of complications if they contract SARS-CoV-2 virus, and therefore report high levels of COVID-19-related distress. This trial will evaluate a brief, evidence-based, online, group-based expressive writing intervention to reduce COVID-19-related distress in people living with IBD at the time of pandemic.
METHODS
A parallel double-blind randomised controlled trial will be conducted. Overall, up to 154 adult participants with IBD and mild-moderate distress will be recruited via patient organisations. Participants will be allocated to the expressive writing intervention or an active control group. All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention. The expressive writing group will participate in the evidenced-based 4-day writing program adapted from Pennebaker and Beall, 1986. The active control group will write about untherapeutic topics provided by researchers. Statistical analysis will be carried out on an intention-to-treat basis and will involve linear mixed effects models.
CONCLUSIONS
If successful, this simple intervention may bring personal and societal benefits, particularly because it is low cost, can be easily implemented online, ensuring social distancing, and be made widely available, during future disasters and to help with trauma-related distress in IBD.
TRIAL REGISTRATION
The trial has been prospectively registered in the Australian New Zealand Trial Registry - ACTRN12620000448943p.",2020,"All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention.","['patients with inflammatory bowel disease (IBD', '154 adult participants with IBD and mild-moderate distress', 'people living with IBD at the time of pandemic', 'people with inflammatory bowel disease (WriteForIBD']","['expressive writing intervention', 'Expressive writing', 'expressive writing intervention or an active control group']","['distress, quality of life, resilience, self-efficacy, social support and disease activity', 'COVID-19-related distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",154.0,0.343985,"All participants will complete questionnaires including measures of distress, quality of life, resilience, self-efficacy, social support and disease activity before and after the intervention (1 week) and at 3 months post-intervention.","[{'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Mikocka-Walus', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia. Electronic address: mikocka@deakin.edu.au.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Olive', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia; IMPACT, School of Medicine, Deakin University, Geelong, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Skvarc', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Beswick', 'Affiliation': 'Department of Gastroenterology, Barwon Health, Geelong, Australia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Massuger', 'Affiliation': ""Crohn's & Colitis Australia, Melbourne, Australia.""}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Raven', 'Affiliation': ""Crohn's & Colitis Australia, Melbourne, Australia.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Emerson', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Subhadra', 'Initials': 'S', 'LastName': 'Evans', 'Affiliation': 'School of Psychology, Deakin University, Melbourne, Australia.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110286']
1442,33171645,Changes in Non-Nutritive Sweetener Consumption Patterns in Response to a Sugar-Sweetened Beverage Reduction Intervention.,"Data are lacking on whether non-nutritive sweeteners (NNS) can be used as a strategy to support decreases in sugar-sweetened beverage (SSB) consumption. The purpose of this secondary analysis of a 6-month SSB-reduction intervention was to explore changes in NNS consumption patterns in Talking Health participants within the SIPsmartER ( n = 101) intervention. Additionally, participant characteristics were compared for three SSB-NNS change groups (decrease SSB/increase NNS; decrease SSB/no increase in NNS; increase/no change in SSB/regardless of NNS). There was a significant increase in aspartame and total NNS intake for participants (mean daily mg increases of 37.2 ± 13.9 and 63.7 ± 18.5, respectively). With the exception of sex, no differences in participant characteristics were found between the three SSB-NNS change groups. Furthermore, no significant changes in weight or body mass index (BMI) were demonstrated between SSB-NNS change groups over time. Diet soda was the most commonly consumed source of NNS; however, other dietary sources of NNS also contributed to intake. At 6 months, intake of sucralose and saccharin were primarily from dietary sources other than diet sodas (94% and 100%, respectively). These findings suggest that NNS may be a feasible strategy to help reduce SSB consumption. This study supports the need to consistently quantify and identify NNS intake, beyond using diet soda intake as a proxy for NNS intake and grouping all NNS types into one variable, to more accurately address the potential health effects of NNS.",2020,"With the exception of sex, no differences in participant characteristics were found between the three SSB-NNS change groups.",['Talking Health participants within the SIPsmartER ( n = 101) intervention'],['SSB-reduction intervention'],"['SSB consumption', 'aspartame and total NNS intake', 'weight or body mass index (BMI']","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3658237', 'cui_str': 'Artificial Sweeteners, Nutritive'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0378432,"With the exception of sex, no differences in participant characteristics were found between the three SSB-NNS change groups.","[{'ForeName': 'Darlene', 'Initials': 'D', 'LastName': 'Acero', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, 295 West Campus Drive, Blacksburg, VA 24061, USA.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Zoellner', 'Affiliation': 'Department of Public Health Sciences, Cancer Center without Walls, University of Virginia, 16 East Main St., Christiansburg, VA 24073, USA.'}, {'ForeName': 'Brenda M', 'Initials': 'BM', 'LastName': 'Davy', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, 295 West Campus Drive, Blacksburg, VA 24061, USA.'}, {'ForeName': 'Valisa E', 'Initials': 'VE', 'LastName': 'Hedrick', 'Affiliation': 'Department of Human Nutrition, Foods, and Exercise, Virginia Tech, 295 West Campus Drive, Blacksburg, VA 24061, USA.'}]",Nutrients,['10.3390/nu12113428']
1443,33171677,"Fixed Dose versus Height-Adjusted Conventional Dose of Intrathecal Hyperbaric Bupivacaine for Caesarean Delivery: A Prospective, Double-Blinded Randomised Trial.","The optimal intrathecal dose of local anaesthetic for caesarean section (CS) anaesthesia is still being debated. We performed a study to compare the effectiveness and safety of spinal anaesthesia with 12.5 mg of hyperbaric bupivacaine and a dosing regimen of conventional doses adjusted to parturient height. One hundred and forty parturients scheduled for elective CS were enrolled. The fixed-dose group (FD) received a spinal block with 12.5 mg of hyperbaric bupivacaine with fentanyl, whereas the adjusted-dose group (AD) received a height-adjusted dose of bupivacaine (9-13 mg) with fentanyl. Sensory block ≥ T5 dermatome within 10 min and no need for supplementary analgesia were set as the composite primary outcome (success). Rates of successful blocks and complications were compared. Complete data were available for 134 cases. Spinal anaesthesia was successful in 58 out of 67 patients in the FD group and 57 out of 67 in the AD group ( p > 0.05). Eight spinals in each group failed to produce a block ≥ T5 in 10 min, and one patient in the FD group and two in the AD group required i.v. analgesics despite sensory block ≥ T5. No differences were noted in terms of hypotension, bradycardia and nausea between the FD and AD groups. Compared to the height-adjusted dose regimen based on conventional doses of hyperbaric bupivacaine, the fixed dose regimen of 12.5 mg was equally effective and did not increase the risk of spinal block-related complications.",2020,Spinal anaesthesia was successful in 58 out of 67 patients in the FD group and 57 out of 67 in the AD group ( p > 0.05).,"['Caesarean Delivery', 'One hundred and forty parturients scheduled for elective CS were enrolled']","['hyperbaric bupivacaine', 'fentanyl', 'spinal block with 12.5 mg of hyperbaric bupivacaine with fentanyl, whereas the adjusted-dose group (AD) received a height-adjusted dose of bupivacaine', 'spinal anaesthesia', 'local anaesthetic for caesarean section (CS) anaesthesia', 'Intrathecal Hyperbaric Bupivacaine']","['hypotension, bradycardia and nausea', 'effectiveness and safety', 'Rates of successful blocks and complications', 'risk of spinal block-related complications', 'Spinal anaesthesia']","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",140.0,0.135604,Spinal anaesthesia was successful in 58 out of 67 patients in the FD group and 57 out of 67 in the AD group ( p > 0.05).,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Białowolska', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical Centre of Postgraduate Education, Orlowski Hospital, Ul. Czerniakowska 231, 00-416 Warsaw, Poland.'}, {'ForeName': 'Bartosz', 'Initials': 'B', 'LastName': 'Horosz', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical Centre of Postgraduate Education, Orlowski Hospital, Ul. Czerniakowska 231, 00-416 Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Sękowska', 'Affiliation': '2nd Department of Obstetrics and Gynaecology, Medical Centre of Postgraduate Education, Bielanski Hospital, Ul. Cegłowska 80, 01-809 Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Malec-Milewska', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical Centre of Postgraduate Education, Orlowski Hospital, Ul. Czerniakowska 231, 00-416 Warsaw, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9113600']
1444,33171716,Clinical Significance of Low-Flow Time in Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation: Results from the RESCUE Registry.,"Limited data are available on the association between low-flow time and survival in patients with in-hospital cardiac arrest (IHCA) who undergo extracorporeal cardiopulmonary resuscitation (ECPR). We evaluated data from 183 IHCA patients who underwent ECPR as a rescue procedure. Patients were divided into two groups: patients undergoing extracorporeal membrane oxygenation as an adjunct to standard cardiopulmonary resuscitation for less than 38 min ( n = 110) or for longer than 38 min ( n = 73). The ECPR ≤ 38 min group had a significantly greater incidence of survival to discharge compared to the ECPR > 38 min group (40.0% versus 24.7%, p = 0.032). The incidence of good neurologic outcomes at discharge tended to be greater in the ECPR ≤ 38 min group than in the ECPR > 38 min group (35.5% versus 24.7%, p = 0.102). The incidences of limb ischemia ( p = 0.354) and stroke ( p = 0.805) were similar between the two groups, but major bleeding occurred less frequently in the ECPR ≤ 38 min group compared to the ECPR > 38 min group ( p = 0.002). Low-flow time ≤ 38 min may reduce the risk of mortality and fatal neurologic damage and could be a measure of optimal management in patients with IHCA.",2020,"The incidences of limb ischemia ( p = 0.354) and stroke ( p = 0.805) were similar between the two groups, but major bleeding occurred less frequently in the ECPR ≤ 38 min group compared to the ECPR > 38 min group ( p = 0.002).","['patients with in-hospital cardiac arrest (IHCA) who undergo extracorporeal cardiopulmonary resuscitation (ECPR', 'Patients Undergoing Extracorporeal Cardiopulmonary Resuscitation', 'patients with IHCA', '183 IHCA patients who underwent ECPR as a rescue procedure']",['extracorporeal membrane oxygenation'],"['incidence of good neurologic outcomes', 'risk of mortality and fatal neurologic damage', 'major bleeding', 'incidence of survival to discharge', 'stroke', 'incidences of limb ischemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C2945695', 'cui_str': 'Limb ischemia'}]",183.0,0.0189874,"The incidences of limb ischemia ( p = 0.354) and stroke ( p = 0.805) were similar between the two groups, but major bleeding occurred less frequently in the ECPR ≤ 38 min group compared to the ECPR > 38 min group ( p = 0.002).","[{'ForeName': 'Ik Hyun', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 51353, Korea.'}, {'ForeName': 'Jeong Hoon', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Jang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Seoul Hospital, Ewha Womans University College of Medicine, Seoul 07804, Korea.'}, {'ForeName': 'Woo Jung', 'Initials': 'WJ', 'LastName': 'Chun', 'Affiliation': 'Division of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 51353, Korea.'}, {'ForeName': 'Ju Hyeon', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 51353, Korea.'}, {'ForeName': 'Yong Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon 51353, Korea.'}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Seoul 02841, Korea.'}, {'ForeName': 'Hyun-Joong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Konkuk University Medical Center, Seoul 05030, Korea.'}, {'ForeName': 'Bum Sung', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Konkuk University Medical Center, Seoul 05030, Korea.'}, {'ForeName': 'Jin-Ok', 'Initials': 'JO', 'LastName': 'Jeong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Daejeon 35015, Korea.'}, {'ForeName': 'Hyun Jong', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Medicine, Sejong General Hospital, Bucheon 14754, Korea.'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Division of Cardiology, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 06351, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9113588']
1445,33199274,Efficacy and safety of fasinumab in patients with chronic low back pain: a phase II/III randomised clinical trial.,"OBJECTIVES
To study the efficacy and safety of fasinumab in moderate-to-severe, chronic low back pain (CLBP).
METHODS
In this phase II/III, double-blind, placebo-controlled study, patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids were randomised to fasinumab 6 or 9 mg subcutaneous every 4 weeks (Q4W), 9 mg intravenous every 8 weeks (Q8W) or placebo. Primary endpoint was change from baseline to week 16 in average daily low back pain intensity (LBPI) numeric rating score. Key secondary efficacy variables included Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA). The results are based on a modified intent-to-treat analysis of 563/800 planned patients when enrolment was stopped early given emerging signals of joint risk in other osteoarthritis (OA) studies at doses being tested here.
RESULTS
Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39). RMDQ and PGA improvements to week 16 were greatest for fasinumab 9 mg intravenous. Numerically greater efficacy occurred in patients with, versus those without, peripheral OA (pOA) over 16 weeks. Treatment-emergent adverse events (AEs) occurred in 274/418 (65.6%) patients in the combined fasinumab groups and 94/140 (67.1%) placebo patients. Joint AEs, mostly rapid progressive OA type 1, were more frequent in the combined fasinumab groups (19 events in 16 patients (3.8%) vs 1 event in 1 patient (0.7%) for placebo); all except one occurred in pOA patients.
CONCLUSIONS
Fasinumab highest doses, but not lower dose, improved both CLBP pain and function. Most joint AEs occurred in pOA patients, consistent with earlier findings in symptomatic OA. Further study is needed of patients with CLBP with and without pOA to determine optimal benefit-risk.",2020,"RESULTS
Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39).","['patients with CLBP with and without pOA', 'patients with CLBP aged ≥35 years with inadequate pain relief/intolerance to acetaminophen, non-steroidal anti-inflammatory drugs and opioids', 'patients with chronic low back pain', 'moderate-to-severe, chronic low back pain (CLBP']","['placebo', 'fasinumab']","['efficacy', 'CLBP pain and function', 'average daily low back pain intensity (LBPI) numeric rating score', 'RMDQ and PGA improvements', 'efficacy and safety', 'Roland-Morris Disability Questionnaire (RMDQ) and Patient Global Assessment (PGA', 'LBPI reductions', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1135862', 'cui_str': 'Genus Poa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708484', 'cui_str': 'Inadequate pain relief'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4519593', 'cui_str': 'fasinumab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.198965,"RESULTS
Significant placebo-adjusted LBPI reductions at week 16 were observed for fasinumab 9 mg Q4W and Q8W (least squares mean (standard error) -0.7 (0.3); both nominal p<0.05), but not 6 mg (-0.3 (0.3); p=0.39).","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Dakin', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Department of Rheumatology, Altoona Center for Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, Arizona, USA.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Skrepnik', 'Affiliation': 'Research Center, Tucson Orthopedic Institute, Tucson, Arizona, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'DiMartino', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Chetachi A', 'Initials': 'CA', 'LastName': 'Emeremni', 'Affiliation': 'R&D, Regeneron Pharmaceuticals Inc, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'R&D, Regeneron Pharmaceuticals Inc, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Stahl', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Geba', 'Affiliation': 'Global Clinical Development, Regeneron Pharmaceuticals Inc, Tarrytown, New York, USA gregory.geba@regeneron.com.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217259']
1446,33200394,Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study.,"INTRODUCTION
In the SPIRIT-H2H (ClinicalTrials.gov: NCT03151551) trial in biologic-naïve patients with active psoriatic arthritis (PsA), ixekizumab (IXE) was superior to adalimumab (ADA) at week 24 in terms of achieving a combined endpoint of ≥ 50% improved response in the American College of Rheumatology scale score (ACR50) and 100% improvement in the Psoriasis Areas and Severity Index (PASI100), and was non-inferior in terms of achieving ACR50. IXE resulted in similar improvements of PsA manifestations irrespective of the use of concomitant conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), while ADA response was higher with concomitant csDMARD use. The aim of this study was to determine the efficacy and safety of treatment with IXE and ADA with or without methotrexate (MTX), the most commonly use csDMARD, through week 52 in patients with PsA.
METHODS
In the open-label, rater-blinded, head-to-head SPIRIT-H2H trial, randomization of patients was stratified by concomitant use of csDMARD and moderate-to-severe plaque psoriasis involvement. In the post-hoc subgroup analysis presented here, subgroups were defined as with/without concomitant MTX use at baseline. Treatment group effects within subgroups were tested using Fisher's exact test. Missing data were imputed using non-responder imputation.
RESULTS
By week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use. When used without concomitant MTX, IXE resulted in significantly higher response versus ADA in terms of the combined ACR50 and PASI100 (p = 0.002) endpoint, minimal disease activity (p = 0.016), and very low disease activity (p = 0.037). The safety of both agents was consistent with their known safety profiles regardless of concomitant MTX use.
CONCLUSION
In PsA patients with inadequate control of the disease, IXE delivers consistent efficacy in several clinical domains of the disease regardless of concomitant MTX use. The efficacy of ADA is increased by the concomitant use of MTX. These findings can inform treatment decisions when considering the need for concomitant MTX use with IXE or ADA at initiation or for long-term maintenance.",2020,"By week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use.","['Biologic-Naïve Patients with Psoriatic Arthritis', 'biologic-naïve patients with active psoriatic arthritis (PsA', 'patients with PsA.\nMETHODS\n\n\nIn the open-label, rater-blinded, head-to-head SPIRIT-H2H trial, randomization of patients was stratified by concomitant use of csDMARD and moderate-to-severe plaque psoriasis involvement']","['IXE', 'MTX, IXE', 'IXE and ADA with or without methotrexate (MTX', 'Ixekizumab with or Without Methotrexate']","['ADA response', 'efficacy and safety', 'efficacy of ADA', 'Efficacy and Safety', 'low disease activity', 'ADA efficacy', 'Rheumatology scale score (ACR50', 'minimal disease activity']","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",,0.0507742,"By week 52, IXE provided similar improvements in the combined ACR50 and PASI100 endpoint, ACR50, and other PsA-related domains regardless of whether IXE was used with or without MTX, while ADA efficacy appeared to be improved with concomitant MTX use.","[{'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sebba', 'Affiliation': 'Arthritis Associates, Palm Harbor, FL, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Ruderman', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Schulze-Koops', 'Affiliation': 'Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, Ludwig-Maximilians University of Munich, Munich, Germany.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sapin', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Gellett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Aubrey Trevelin', 'Initials': 'AT', 'LastName': 'Sprabery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lingnan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'de la Torre', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Soyi', 'Initials': 'S', 'LastName': 'Liu-Leage', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sreekumar', 'Initials': 'S', 'LastName': 'Pillai', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Reis', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'School of Medicine, Griffith University, Brisbane, QLD, Australia. drpnash@tpg.com.au.'}]",Rheumatology and therapy,['10.1007/s40744-020-00250-3']
1447,33152354,Preclinical neurorehabilitation with environmental enrichment confers cognitive and histological benefits in a model of pediatric asphyxial cardiac arrest.,"Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities that affect overall quality of life, yet rehabilitation is neither routinely nor systematically provided. Environmental enrichment (EE) is considered a preclinical model of neurorehabilitation and thus we sought to investigate its efficacy in our established model of pediatric ACA. Male Sprague-Dawley rat pups (post-natal day 16-18) were randomly assigned to ACA (9.5 min) or Sham injury. After resuscitation, the rats were assigned to 21 days of EE or standard (STD) housing during which time motor, cognitive, and anxiety-like (i.e., affective) outcomes were assessed. Hippocampal CA 1 cells were quantified on post-operative day-22. Both ACA + STD and ACA + EE performed worse on beam-balance vs. Sham controls (p < 0.05) and did not differ from one another overall (p > 0.05); however, a single day analysis on the last day of testing revealed that the ACA + EE group performed better than the ACA + STD group (p < 0.05) and did not differ from the Sham controls (p > 0.05). Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test. Spatial learning and declarative memory were improved and CA 1 neuronal loss was attenuated in the ACA + EE vs. ACA + STD group (p < 0.05). Collectively, the data suggest that providing rehabilitation after pediatric ACA can reduce histopathology and improve motor and cognitive ability.",2020,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"['Male Sprague-Dawley rat pups (post-natal day 16-18', 'Pediatric asphyxial cardiac arrest (ACA) often leaves children with physical, cognitive, and emotional disabilities']","['Environmental enrichment (EE', 'ACA']","['motor and cognitive ability', 'CA 1 neuronal loss', 'Spatial learning and declarative memory']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034715', 'cui_str': 'Sprague-Dawley rat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0454729', 'cui_str': 'Natal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}, {'cui': 'C0582587', 'cui_str': 'Visual learning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0463264,Both Sham groups performed better than ACA + STD (p < 0.05) but did not differ from ACA + EE (p > 0.05) in the open field test.,"[{'ForeName': 'Mioara D', 'Initials': 'MD', 'LastName': 'Manole', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: manomd@upmc.edu.'}, {'ForeName': 'Marcus J A', 'Initials': 'MJA', 'LastName': 'Hook', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; University of Bath, Claverton Down, Bath BA2 7AY, UK.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Nicholas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Brittany P', 'Initials': 'BP', 'LastName': 'Nelson', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Adanna C', 'Initials': 'AC', 'LastName': 'Liu', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Quinn C', 'Initials': 'QC', 'LastName': 'Stezoski', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Rowley', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Cheng', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Alexander', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Eleni H', 'Initials': 'EH', 'LastName': 'Moschonas', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Corina O', 'Initials': 'CO', 'LastName': 'Bondi', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Neurobiology, University of Pittsburgh, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Kline', 'Affiliation': 'Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA, United States of America; Center for the Neural Basis of Cognition, University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Critical Care, Medicine University of Pittsburgh, Pittsburgh, PA, United States of America; Department of Psychology, University of Pittsburgh, Pittsburgh, PA, United States of America. Electronic address: klineae@upmc.edu.'}]",Experimental neurology,['10.1016/j.expneurol.2020.113522']
1448,33162202,A mixture model to assess the the immunogenicity of an oral rotavirus vaccine among healthy infants in Niger.,"Analysis of immunogenicity data is a critical component of vaccine development, providing a biological basis to support any observed protection from vaccination. Conventional methods for analyzing immunogenicity data use either post-vaccination titer or change in titer, often defined as a binary variable using a threshold. These methods are simple to implement but can be limited especially in populations experiencing natural exposure to the pathogen. A mixture model can overcome the limitations of the conventional approaches by jointly modeling the probability of an immune response and the level of the immune marker among those who respond. We apply a mixture model to analyze the immunogenicity of an oral, pentavalent rotavirus vaccine in a cohort of children enrolled into a placebo-controlled vaccine efficacy trial in Niger. Among children with undetectable immunoglobulin A (IgA) at baseline, vaccinated children had 5.2-fold (95% credible interval (CrI) 3.7, 8.3) higher odds of having an IgA response than placebo children, but the mean log IgA among vaccinated responders was 0.9-log lower (95% CrI 0.6, 1.3) than among placebo responders. This result implies that the IgA response generated by vaccination is weaker than that generated by natural infection. Multivariate logistic regression of seroconversion defined by ≥ 3-fold rise in IgA similarly found increased seroconversion among vaccinated children, but could not demonstrate lower IgA among those who seroresponded. In addition, we found that the vaccine was less immunogenic among children with detectable IgA pre-vaccination, and that pre-vaccination infant serum IgG and mother's breast milk IgA modified the vaccine immunogenicity. Increased maternal antibodies were associated with weaker IgA response in placebo and vaccinated children, with the association being stronger among vaccinated children. The mixture model is a powerful and flexible method for analyzing immunogenicity data and identifying modifiers of vaccine response and independent predictors of immune response.",2020,"Increased maternal antibodies were associated with weaker IgA response in placebo and vaccinated children, with the association being stronger among vaccinated children.","['a cohort of children enrolled into a placebo-controlled vaccine efficacy trial in Niger', 'healthy infants in Niger']","['placebo', 'oral rotavirus vaccine', 'pentavalent rotavirus vaccine']","['IgA response', 'Increased maternal antibodies']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0028074', 'cui_str': 'Niger'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C2713569', 'cui_str': 'pentavalent rotavirus vaccine (RV5)'}]","[{'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody'}]",,0.163971,"Increased maternal antibodies were associated with weaker IgA response in placebo and vaccinated children, with the association being stronger among vaccinated children.","[{'ForeName': 'Matt D T', 'Initials': 'MDT', 'LastName': 'Hitchings', 'Affiliation': 'Department of Biology, University of Florida, United States; Emerging Pathogens Institute, University of Florida, United States. Electronic address: mhitchings@ufl.edu.'}, {'ForeName': 'Derek A T', 'Initials': 'DAT', 'LastName': 'Cummings', 'Affiliation': 'Department of Biology, University of Florida, United States; Emerging Pathogens Institute, University of Florida, United States.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Grais', 'Affiliation': 'Department of Research, Epicentre, Paris, France.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Isanaka', 'Affiliation': 'Department of Research, Epicentre, Paris, France; Departments of Nutrition and Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.10.079']
1449,33164850,"Acute exercise, memory, and neural activation in young adults.","Acute exercise benefits memory, and the temporal placement of exercise relative to exposure can affect the magnitude of benefits observed. Although the temporal placement appears to be important, there is a limited understanding as to how cognitive benefits in response to acute exercise are achieved. Hence, we conducted a two-part study including a behavioral study and a follow-up functional magnetic resonance imaging (fMRI) study to advance our understanding of the potential role of the effects of exercise on memory and neural activation. For Study One, we assessed the effect of acute exercise on memory in young adults. Participants were randomized to exercise before exposure for 20 min (before only, BO), after exposure for 20 min (After Only, AO), before and after exposure for 10 min at each time (before and after, BA), or to receive no exercise (No-exercise Control, NC). Similar to previous findings, any exercise prior to exposure (BO, BA) benefited some aspects of memory performance. Interestingly, the more consistent and larger benefits were seen with a shorter duration of exercise both before and after exposure (BA). Study Two replicated the methods of Study One comparing the BA condition (which had the most robust benefits) to the NC condition while collecting fMRI data during the memory task. Analyses assessed condition differences of activation during encoding and recall. There were no condition differences during memory encoding, however there was a condition effect on activation in occipito-temporal regions during the memory recall trials. Consistent with previous research, exercise appears to benefit memory with some exercise prior to exposure being important for the benefits achieved. Further, exercise affects neural activation and the results appear complementary to the behavior findings. Future research should use a within-subjects design to control for heterogeneity in behavior and neural activation.",2020,"There were no condition differences during memory encoding, however there was a condition effect on activation in occipito-temporal regions during the memory recall trials.",['young adults'],"['no exercise (No-exercise Control, NC', 'acute exercise']","['Acute exercise, memory, and neural activation', 'memory and neural activation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.0370187,"There were no condition differences during memory encoding, however there was a condition effect on activation in occipito-temporal regions during the memory recall trials.","[{'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Slutsky-Ganesh', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC, United States of America. Electronic address: abslutsk@uncg.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Etnier', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC, United States of America.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Labban', 'Affiliation': 'University of North Carolina at Greensboro, Greensboro, NC, United States of America.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.09.018']
1450,33165621,Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial.,"Importance
Data on the efficacy of hydroxychloroquine for the treatment of coronavirus disease 2019 (COVID-19) are needed.
Objective
To determine whether hydroxychloroquine is an efficacious treatment for adults hospitalized with COVID-19.
Design, Setting, and Participants
This was a multicenter, blinded, placebo-controlled randomized trial conducted at 34 hospitals in the US. Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020. The planned sample size was 510 patients, with interim analyses planned after every 102 patients were enrolled. The trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients.
Interventions
Patients were randomly assigned to hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses) (n = 242) or placebo (n = 237).
Main Outcomes and Measures
The primary outcome was clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities). The primary outcome was analyzed with a multivariable proportional odds model, with an adjusted odds ratio (aOR) greater than 1.0 indicating more favorable outcomes with hydroxychloroquine than placebo. The trial included 12 secondary outcomes, including 28-day mortality.
Results
Among 479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed. The median duration of symptoms prior to randomization was 5 days (interquartile range [IQR], 3 to 7 days). Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]). None of the 12 secondary outcomes were significantly different between groups. At 28 days after randomization, 25 of 241 patients (10.4%) in the hydroxychloroquine group and 25 of 236 (10.6%) in the placebo group had died (absolute difference, -0.2% [95% CI, -5.7% to 5.3%]; aOR, 1.07 [95% CI, 0.54 to 2.09]).
Conclusions and Relevance
Among adults hospitalized with respiratory illness from COVID-19, treatment with hydroxychloroquine, compared with placebo, did not significantly improve clinical status at day 14. These findings do not support the use of hydroxychloroquine for treatment of COVID-19 among hospitalized adults.
Trial Registration
ClinicalTrials.gov: NCT04332991.",2020,"Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]).","['Adults hospitalized with respiratory symptoms from severe acute respiratory syndrome coronavirus 2 infection were enrolled between April 2 and June 19, 2020, with the last outcome assessment on July 17, 2020', 'Hospitalized Patients With COVID-19', 'adults hospitalized with COVID-19', '479 patients', '479 patients who were randomized (median age, 57 years; 44.3% female; 37.2% Hispanic/Latinx; 23.4% Black; 20.1% in the intensive care unit; 46.8% receiving supplemental oxygen without positive pressure; 11.5% receiving noninvasive ventilation or nasal high-flow oxygen; and 6.7% receiving invasive mechanical ventilation or extracorporeal membrane oxygenation), 433 (90.4%) completed the primary outcome assessment at 14 days and the remainder had clinical status imputed', '510 patients, with interim analyses planned after every 102 patients were enrolled', '34 hospitals in the US', 'adults hospitalized with respiratory illness']","['placebo', 'hydroxychloroquine', 'Hydroxychloroquine']","['died', '28-day mortality', 'clinical status 14 days after randomization as assessed with a 7-category ordinal scale ranging from 1 (death) to 7 (discharged from the hospital and able to perform normal activities', 'clinical status', 'median duration of symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}]",12.0,0.655421,"Clinical status on the ordinal outcome scale at 14 days did not significantly differ between the hydroxychloroquine and placebo groups (median [IQR] score, 6 [4-7] vs 6 [4-7]; aOR, 1.02 [95% CI, 0.73 to 1.42]).","[{'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Leither', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, Utah.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Roy G', 'Initials': 'RG', 'LastName': 'Brower', 'Affiliation': 'Pulmonary and Critical Care Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Chang', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, David Geffen School of Medicine at UCLA, Ronald Reagan-UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Collins', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Eppensteiner', 'Affiliation': 'Department of Surgery, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Filbin', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Gibbs', 'Affiliation': 'Section of Pulmonary, Critical Care, Allergy and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Adit A', 'Initials': 'AA', 'LastName': 'Ginde', 'Affiliation': 'Department of Emergency Medicine, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Gong', 'Affiliation': 'Division of Epidemiology and Population Health, Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Hayden', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Emergency Medicine and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health and Science University School of Medicine, Portland.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, Tennessee.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Matthay', 'Affiliation': 'Cardiovascular Research Institute, Departments of Medicine and Anesthesia, University of California, San Francisco.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora.'}, {'ForeName': 'Pauline K', 'Initials': 'PK', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Bryce R H', 'Initials': 'BRH', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Washington, Seattle.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Nathan I', 'Initials': 'NI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Emergency Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Steingrub', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School-Baystate, Springfield.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Ulysse', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weissman', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Yealy', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'B Taylor', 'Initials': 'BT', 'LastName': 'Thompson', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Brown', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, Utah.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.22240']
1451,33161276,A novel multi-study intervention investigating the short and long term effects of a posture bra on whole body and breast kinematics.,"BACKGROUND
Poor standing posture has been reported in women with larger breasts, increasing the risk of back pain. Whilst breast reduction surgery can improve posture, conservative measures such as special bras may offer short or long-term relief of symptoms without surgical intervention.
RESEARCH QUESTION
This study aimed to utilise a multi-study intervention to investigate the short and long-term kinematic effects of wearing a posture bra.
METHODS
Study one utilised biomechanics and physiotherapy expertise to modify the design of a prototype bra to improve posture and breast kinematics; resulting in a second-generation posture bra. To test this bra, 24 females were randomly assigned to control and intervention groups. The control group wore their everyday bra; the intervention group wore the generation 2 posture bra in place of their everyday bra for three months. Pre and post intervention, posture (spine curvature, scapula position, whole body alignment) and breast kinematics were assessed during sitting, standing and walking. Short-term effects of the posture bra were compared to an everyday bra and no bra (study two), whilst the long-term effects were compared using the no bra condition (study three).
RESULTS
Biomechanical intervention improved posture and breast kinematics in a prototype posture bra resulting in a second-generation prototype. Pre-intervention, the generation 2 posture bra significantly improved scapula retraction by 6° during both sitting and standing, but also increased deviation of whole body alignment compared to everyday bra and no bra conditions. During walking the posture bra reduced breast motion by 17 % compared to the everyday bra. Following the three-month wearer intervention, scapula depression significantly improved in the intervention group.
SIGNIFICANCE
A biomechanically informed posture bra was able to effectively support the breasts and improve scapula position without compromising spinal curvature, reducing the risk of musculoskeletal pain associated with poor posture.",2020,"Pre-intervention, the generation 2 posture bra significantly improved scapula retraction by 6° during both sitting and standing, but also increased deviation of whole body alignment compared to everyday bra and no bra conditions.","['24 females', 'women with larger breasts']","['wearing a posture bra', 'Biomechanical intervention', 'control group wore their everyday bra; the intervention group wore the generation 2 posture bra in place of their everyday bra for three months']","['Pre and post intervention, posture (spine curvature, scapula position, whole body alignment) and breast kinematics', 'breast motion', 'scapula depression', 'scapula retraction', 'posture and breast kinematics']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0235648', 'cui_str': 'Breast enlargement female'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C4082119', 'cui_str': 'Three months'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0037932', 'cui_str': 'Curvature of spine'}, {'cui': 'C0036277', 'cui_str': 'Bone structure of scapula'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}]",24.0,0.0262088,"Pre-intervention, the generation 2 posture bra significantly improved scapula retraction by 6° during both sitting and standing, but also increased deviation of whole body alignment compared to everyday bra and no bra conditions.","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Mills', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom. Electronic address: chris.mills@port.ac.uk.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Exell', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Wakefield-Scurr', 'Affiliation': 'School of Sport, Health and Exercise Science, Spinnaker Building, University of Portsmouth, PO1 2ER, United Kingdom.'}]",Gait & posture,['10.1016/j.gaitpost.2020.10.031']
1452,33161293,Effects of virtual reality training intervention on predictive motor control of children with DCD - A randomized controlled trial.,"It has been hypothesised that deficits in the functions of predictive motor control and internal modeling may contribute to motor control issues of children with Developmental Coordination Disorder (DCD). Virtual reality (VR) technologies have great potential to provide opportunity for Motor observation and motor imagery (MI) which could enhance learning and development of motor skills in children with DCD. Thus, the present study aimed to investigate the benefits of a VR training intervention to improve predictive motor control functions of children with DCD. Forty female children with DCD (aged 7-10) were randomly assigned to VR and control groups. In this study, an experimental pre-post and follow-up design was used, and Predictive motor control functions were measured before and after the VR intervention and two-months later. Predictive motor control was evaluated using MI (by hand rotation task), action planning (by sword placement task), and rapid and online control (by rotational tracking task) tests. VR intervention consisted of a selection of Xbox 360 Kinect games that were performed for sixteen 30-min sessions over 8 weeks. Compared to the control group, the VR group improved significantly on measures of MI, motor planning, and rapid and online control scores from pre- to post-test and retained their performance to follow-up. Overall, it seems that virtual reality training program may be used as an appropriate intervention approach for developing the ability of MI and predictive motor control functions in DCD children.",2020,"Compared to the control group, the VR group improved significantly on measures of MI, motor planning, and rapid and online control scores from pre- to post-test and retained their performance to follow-up.","['children with DCD', 'children with Developmental Coordination Disorder (DCD', 'Forty female children with DCD (aged 7-10', 'DCD children']","['VR training intervention', 'Virtual reality (VR) technologies', 'VR intervention', 'MI (by hand rotation task), action planning (by sword placement task), and rapid and online control (by rotational tracking task) tests', 'virtual reality training intervention']","['MI, motor planning, and rapid and online control scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011757', 'cui_str': 'Developmental coordination disorder'}, {'cui': 'C0870604', 'cui_str': 'Female child'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0522656', 'cui_str': 'Sword'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0122156,"Compared to the control group, the VR group improved significantly on measures of MI, motor planning, and rapid and online control scores from pre- to post-test and retained their performance to follow-up.","[{'ForeName': 'Soghra', 'Initials': 'S', 'LastName': 'EbrahimiSani', 'Affiliation': 'Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran. Electronic address: Soghra_Ebrahimisani@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Sohrabi', 'Affiliation': 'Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran. Electronic address: sohrabi@um.ac.ir.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran. Electronic address: hamidtaheri@um.ac.ir.'}, {'ForeName': 'Mohammad Tagi', 'Initials': 'MT', 'LastName': 'Agdasi', 'Affiliation': 'Department of Motor Behavior, Faculty of Sport Sciences, University of Tabriz, Tabriz, Iran. Electronic address: mt_aghdasi@tabrizu.ac.ir.'}, {'ForeName': 'Shahrokh', 'Initials': 'S', 'LastName': 'Amiri', 'Affiliation': 'Research Center of Psychiatry and Behavioral Sciences, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Sh_Amiri1348@yahoo.com.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103768']
1453,33169699,Immediate effects of a single session of physical exercise on cognition and cerebral blood flow: A randomized controlled study of older adults.,"BACKGROUND
Regular physical activity is beneficial for cognitive performance in older age. A single bout of aerobic physical exercise can transiently improve cognitive performance. Researchers have advanced improvements in cerebral circulation as a mediator of long-term effects of aerobic physical exercise on cognition, but the immediate effects of exercise on cognition and cerebral perfusion are not well characterized and the effects in older adults are largely unknown.
METHODS
Forty-nine older adults were randomized to a 30-min aerobic exercise at moderate intensity or relaxation. Groups were matched on age and cardiovascular fitness (VO2 max). Average Grey Matter Blood Flow (GMBF), measured by a pulsed arterial-spin labeling (pASL) magnetic resonance imaging (MRI) acquisition, and working memory performance, measured by figurative n-back tasks with increasing loads were assessed before and 7 min after exercising/resting.
RESULTS
Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity. GMBF decreased after exercise, relative to the control (resting) group. In the exercise group, higher n-back performance after exercise was associated with lower GMBF in the right hippocampus, left medial frontal cortex and right orbitofrontal cortex, and higher cardiovascular fitness was associated with lower GMBF.
CONCLUSION
The decrease of GMBF reported in younger adults shortly after exercise also occurs in older adults and relates to cardiovascular fitness, potentially supporting the link between cardiovascular fitness and cerebrovascular reactivity in older age.",2020,"RESULTS
Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity.","['older adults', 'Forty-nine older adults', 'older age']","['aerobic physical exercise', 'physical exercise', '30-min aerobic exercise at moderate intensity or relaxation']","['cognitive performance', 'GMBF', 'Average Grey Matter Blood Flow (GMBF), measured by a pulsed arterial-spin labeling (pASL) magnetic resonance imaging (MRI) acquisition, and working memory performance, measured by figurative n-back tasks with increasing loads', 'higher n-back performance', 'cardiovascular fitness', 'cognition and cerebral blood flow']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231337', 'cui_str': 'Senility'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}]",49.0,0.0349679,"RESULTS
Accuracy on the n-back task increased from before to after exercising/resting regardless of the type of activity.","[{'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Olivo', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden. Electronic address: gaia.olivo@ki.se.'}, {'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Garzón', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lebedev', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Wåhlin', 'Affiliation': 'Department of Radiation Sciences, Umeå University, Umeå, Sweden; Umeå Center for Functional Brain Imaging (UFBI), Umeå University, Umeå, Sweden.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'The Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekblom', 'Affiliation': 'The Swedish School of Sport and Health Sciences, Stockholm, Sweden; Department of Neuroscience, Karolinska Institute, Stockhom, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center (ARC), Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Tomtebodavägen 18A, 171 65 Stockholm, Sweden; Department of Psychology, University of Gothenburg, Gothenburg, Sweden.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117500']
1454,33174199,Head elevation and laryngeal mask airway Supreme insertion: A randomized controlled trial.,"BACKGROUND
A laryngeal mask airway (LMA) is usually inserted by conventional 7 cm head elevation. However, little is known about the association of head elevation degree and LMA insertion. We hypothesized that 14 cm head elevation would increase the first attempt success rate of LMA Supreme insertion compared with conventional 7 cm head elevation in patients undergoing transurethral resection of bladder tumour.
METHODS
Patients were randomly allocated to the high group (n = 55, 14 cm head elevation) or the control group (n = 55, conventional 7 cm head elevation). The primary outcome was the first attempt success rate of LMA Supreme insertion.
RESULTS
The first attempt success rate was significantly higher in the high group than in the control group (53 [96.4%] vs 40 [72.7%], P = .001, relative risk = 1.30, 95% confidence interval [CI] = 1.12-1.57, absolute risk reduction = 23.7%). Fibreoptic bronchoscope grade 4 (ie optimal position of the LMA) was significantly higher in the high group (35 [64.8%] vs 18 [36.7%], P = .004, relative risk = 1.76, 95% CI = 1.16-2.68, absolute risk reduction = 30.9%).
CONCLUSIONS
Head elevation of 14 cm height increased the first attempt success rate of LMA Supreme insertion and fibreoptic bronchoscopic grade in patients undergoing transurethral resection of bladder tumour. High head elevation can be an effective option for successful LMA Supreme insertion. Trial Registry Number: Clinicaltrials.gov (NCT04229862).",2020,"The first attempt success rate was significantly higher in the high than in the control group (53 [96.4%] vs. 40 [72.7%], P = 0.001, relative risk = 1.30, 95% confidence interval [CI] = 1.12-1.57, absolute risk reduction = 23.7%).","['patients undergoing transurethral resection of bladder tumour', 'Patients were randomly allocated to the high group (n = 55, 14 cm head elevation) or the control group (n = 55, conventional 7 cm head elevation']","['Head elevation and laryngeal mask airway Supreme insertion', 'laryngeal mask airway (LMA']","['success rate', 'success rate of LMA Supreme insertion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C3282376', 'cui_str': 'Supreme'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.152818,"The first attempt success rate was significantly higher in the high than in the control group (53 [96.4%] vs. 40 [72.7%], P = 0.001, relative risk = 1.30, 95% confidence interval [CI] = 1.12-1.57, absolute risk reduction = 23.7%).","[{'ForeName': 'Jun-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jihion', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Hyuk', 'Initials': 'JH', 'LastName': 'Hong', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jai-Hyun', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Kug', 'Initials': 'YK', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13742']
1455,33170576,Two-Thumb Encircling Technique With a Novel Compression Assist Device Provides Safe and Effective Chest Compressions in Infants.,"OBJECTIVE
Currently, 2-thumb encircling technique is recommended in 2-rescuer infant cardiopulmonary resuscitation (CPR). However, many complications can occur during CPR. Therefore, we developed a novel compression assist device (Reheart) that can reduce chest compression area and determined whether using our device provides better compression quality.
METHODS
A novel compression assist device consists of 2 parts. The upper part was designed to put 2 thumbs together in the thumb sleeves, and the lower part was designed based on a circular rubber plate with a 2.0-cm diameter to confine compression area. Infant manikin CPR simulations using the 2-thumb encircling technique with Reheart and without Reheart were sequentially performed by participants in randomized crossover fashion.
RESULTS
A total of 32 health care providers were included. The average age of the participants was 30.2 ± 3.5 years, and 21 participants (65.6%) were male. The accuracy in the Reheart group was better than that in the conventional group (proportion of compression on target area, 52.5% ± 13.2% vs 35.4% ± 17.6%; P < 0.001). The difference in the rates of chest compressions between the 2 groups was not significant (119.6 ± 14.4 vs 120.7 ± 14.0 compressions/min, P = 0.59). The depth of chest compressions was also not significantly different between the 2 groups (34.5 mm [33.6-34.9 mm] vs 34.2 mm [33.0-34.9 mm], P = 0.32).
CONCLUSIONS
Our new compression assist device can help provide safe and effective chest compressions during 2-rescuer infant CPR.",2020,"The accuracy in the Reheart group was better than that in the conventional group (proportion of compression on target area, 52.5% ± 13.2% vs 35.4% ± 17.6%; P < 0.001).","['32 health care providers', '2-rescuer infant cardiopulmonary resuscitation (CPR', 'The average age of the participants was 30.2 ± 3.5 years, and 21 participants (65.6%) were male', 'Infants']",[],"['depth of chest compressions', 'rates of chest compressions']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]",,0.0341644,"The accuracy in the Reheart group was better than that in the conventional group (proportion of compression on target area, 52.5% ± 13.2% vs 35.4% ± 17.6%; P < 0.001).","[{'ForeName': 'Se Uk', 'Initials': 'SU', 'LastName': 'Lee', 'Affiliation': 'From the Department of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine.'}, {'ForeName': 'Do Kyun', 'Initials': 'DK', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul.'}, {'ForeName': 'Ikwan', 'Initials': 'I', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul.'}, {'ForeName': 'Jae Yun', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul.'}, {'ForeName': 'So Hyun', 'Initials': 'SH', 'LastName': 'Paek', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul.'}, {'ForeName': 'Joong Wan', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Bundang Hospital, Seong-nam, Korea.'}, {'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Kwak', 'Affiliation': 'Department of Emergency Medicine, Seoul National University Hospital, Seoul.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001738']
1456,31430618,Trait self-control predicts drinking patterns during treatment for alcohol use disorder and recovery up to three years following treatment.,"To more fully understand recovery from alcohol use disorder, we must consider several ways in which reductions in drinking and improvements in psychosocial functioning may occur. Previous research has demonstrated various patterns of drinking and functioning during and after behavioral treatment for alcohol use disorder, including groups of individuals who consume alcohol at low-risk levels and those that report occasional heavy drinking yet good psychosocial functioning. This study aimed to identify whether trait self-control, which has previously been associated with alcohol treatment outcomes, was a predictor of drinking patterns during treatment as well as three years following treatment. Latent variable mixture modeling was used to identify seven classes of drinking patterns during treatment and four profiles of drinking and psychosocial function after treatment. We found that membership in the low-risk drinking class was predicted by greater trait self-control than several of the other classes, including the consistent abstinence class. Furthermore, we found that greater trait self-control predicted membership in two high-functioning recovery profiles at three years following treatment, including a high functioning occasional heavy drinking profile. These findings suggest that self-control is an important predictor of recovery, particularly for a non-abstinent recovery.",2019,Latent variable mixture modeling was used to identify seven classes of drinking patterns during treatment and four profiles of drinking and psychosocial function after treatment.,[],[],[],[],[],[],,0.0126241,Latent variable mixture modeling was used to identify seven classes of drinking patterns during treatment and four profiles of drinking and psychosocial function after treatment.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Stein', 'Affiliation': 'Department of Psychology and Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, United States of America. Electronic address: elenastein@unm.edu.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology and Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, United States of America.'}]",Addictive behaviors,['10.1016/j.addbeh.2019.106083']
1457,33180211,Exploring why we learn from productive failure: insights from the cognitive and learning sciences.,"Advances in Health Sciences Education (AHSE) has been at the forefront of the cognitive wave in health professions education for the past 25 years. One example is research on productive failure, a teaching strategy that asks learners to attempt to generate solutions to difficult problems before receiving instruction. This study compared the effectiveness of productive failure with indirect failure to further characterize the underpinning cognitive mechanisms of productive failure. Year one pharmacy students (N = 42) were randomly assigned to a productive failure or an indirect failure learning condition. The problem of estimating renal function based on serum creatinine was described to participants in the productive failure learning condition, who were then asked to generate a solution. Participants in the indirect failure condition learned about the same problem and were given incorrect solutions that other students had created, as well as the Cockcroft-Gault formula, and asked to compare and contrast the equations. Immediately thereafter all participants completed a series of tests designed to assess acquisition, application, and preparation for future learning (PFL). The tests were repeated after a 1-week delay. Participants in the productive failure condition outperformed those in the indirect failure condition, both on the immediate PFL assessment, and after a 1-week delay. These results emphasize the crucial role of generation in learning. When preparing novice students to learn new knowledge in the future, generating solutions to problems prior to instruction may be more effective than simply learning about someone else's mistakes. Struggle and failure are most productive when experienced personally by a learner because it requires the learner to engage in generation, which deepens conceptual understanding.",2020,"Participants in the productive failure condition outperformed those in the indirect failure condition, both on the immediate PFL assessment, and after a 1-week delay.",['Year one pharmacy students (N\u2009=\u200942'],['productive failure or an indirect failure learning condition'],[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],42.0,0.020739,"Participants in the productive failure condition outperformed those in the indirect failure condition, both on the immediate PFL assessment, and after a 1-week delay.","[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Steenhof', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, ON, M5S 3M2, Canada. naomi.steenhof@utoronto.ca.'}, {'ForeName': 'Nicole N', 'Initials': 'NN', 'LastName': 'Woods', 'Affiliation': 'The Wilson Centre, University of Toronto and University Health Network, Toronto, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mylopoulos', 'Affiliation': 'The Wilson Centre, University of Toronto and University Health Network, Toronto, Canada.'}]",Advances in health sciences education : theory and practice,['10.1007/s10459-020-10013-y']
1458,33176306,Comprehensive Geriatric Care to Improve Mobility after Hip Fracture: An RCT.,"BACKGROUND
Comprehensive geriatric care (CGC) for older adults during hospitalization for hip fracture can improve mobility, but it is unclear whether CGC delivered after a return to community living improves mobility compared with usual post-discharge care.
OBJECTIVE
To determine if an outpatient clinic-based CGC regime in the first year after hip fracture improved mobility performance at 12 months.
METHODS
A two-arm, 1:1 parallel group, pragmatic, single-blind, single-center, randomized controlled trial at 3 hospitals in Vancouver, BC, Canada. Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3-12 months, who had no dementia and walked ≥10 m before the fracture occurred. Target enrollment was 130 participants. Clinic-based CGC was delivered by a geriatrician, physiotherapist, and occupational therapist. Primary outcome was the Short Physical Performance Battery (SPPB; 0-12) at 12 months.
RESULTS
We randomized 53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (n = 26) and usual care (UC, n = 27), and 49/53 (92%) completed the study. Mean 12-month (SD) SPPB scores in the intervention and UC groups were 9.08 (3.03) and 8.24 (2.44). The between-group difference was 0.9 (95% CI -0.3 to 2.0, p = 0.13). Adverse events were similar in the 2 groups.
CONCLUSION
The small sample size of less than half our recruitment target precludes definitive conclusions about the effect of our intervention. However, our results are consistent with similar studies on this population and intervention.",2020,"Adverse events were similar in the 2 groups.
","['53/313 eligible participants with a mean (SD) age of 79.7 (7.9) years to intervention (n = 26) and usual care (UC, n = 27), and 49/53 (92%) completed the study', 'older adults during hospitalization for hip fracture', 'Participants were community-dwelling adults, aged ≥65 years, with a hip fracture in the previous 3-12 months, who had no dementia and walked ≥10 m before the fracture occurred']",['Comprehensive geriatric care (CGC'],"['mobility performance', 'Short Physical Performance Battery (SPPB; 0-12) at 12 months', 'Adverse events', 'Mean 12-month (SD) SPPB scores']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}]",,0.181649,"Adverse events were similar in the 2 groups.
","[{'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Cook', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Penelope M A', 'Initials': 'PMA', 'LastName': 'Brasher', 'Affiliation': 'Centre for Clinical Epidemiology and Evaluation, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Guy', 'Affiliation': 'School of Population & Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Stirling', 'Initials': 'S', 'LastName': 'Bryan', 'Affiliation': 'Centre for Clinical Epidemiology and Evaluation, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Donaldson', 'Affiliation': 'Centre for Clinical Epidemiology and Evaluation, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Joanie', 'Initials': 'J', 'LastName': 'Sims-Gould', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'McKay', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karim M', 'Initials': 'KM', 'LastName': 'Khan', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Maureen C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'Centre for Hip Health and Mobility, University of British Columbia, Vancouver, British Columbia, Canada, maureen.ashe@ubc.ca.'}]",Gerontology,['10.1159/000510903']
1459,32826406,Revisiting Risk-stratified Whiplash-exposed Patients 12 to 14 Years After Injury.,"OBJECTIVE
The objective of this study was to evaluate the long-term predictive value of the Danish Whiplash Group Risk Assessment Score (DWGRAS) with 7 risk strata.
DESIGN
E-questionnaire-based follow-up study (n=927) combining 2 cohorts of whiplash-injured patients, 1 observational (n=187) and 1 interventional randomized controlled trial (n=740).
METHODS
Nine hundred twenty-seven previously healthy persons exposed to acute whiplash injury during motor vehicle collision were sent letter by postal service asking the addressee if they would respond to an E-questionnaire. Outcome measures were: whiplash-related disability, pain, use of medication/nonmedical treatment, work capacity.
RESULTS
The response rate was 37%. Fifty-five percent reported whiplash-related disability. Fourteen percent reported daily symptoms. A strong relationship was found between risk strata and impact of event and between risk strata and disabling symptoms.
CONCLUSIONS
Internal and long-term validation of DWGRAS was performed, but a low response rate indicates that results should be interpreted with caution. Furthermore, external validation needs to be done in long-term studies. An receiver operating characteristics curve of 0.73 (95% confidence interval 0.67; 0.79) predicting daily or weekly whiplash-related disability after 12 to 14 years was found using the DWGRAS risk score.",2020,"Outcome measures were: whiplash-related disability, pain, use of medication/nonmedical treatment, work capacity.
","['E-questionnaire-based follow-up study (n=927) combining 2 cohorts of whiplash-injured patients, 1 observational (n=187) and 1 interventional randomized controlled trial (n=740', 'Revisiting Risk-stratified Whiplash-exposed Patients 12 to 14 Years', 'Nine hundred twenty-seven previously healthy persons exposed to acute whiplash injury during motor vehicle collision were sent letter by postal service asking the addressee if they would respond to an E-questionnaire']",[],"['daily or weekly whiplash-related disability', 'whiplash-related disability', 'whiplash-related disability, pain, use of medication/nonmedical treatment, work capacity', 'response rate', 'daily symptoms']","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0175845', 'cui_str': 'Motor vehicle'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0032756', 'cui_str': 'Service, Postal'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0043145', 'cui_str': 'Whiplash injury to neck'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",927.0,0.116215,"Outcome measures were: whiplash-related disability, pain, use of medication/nonmedical treatment, work capacity.
","[{'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Rasmussen', 'Affiliation': 'Danish Pain Research Centre Aarhus University Hospital.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kongsted', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Carstensen', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital.'}, {'ForeName': 'Troels S', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Danish Pain Research Centre Aarhus University Hospital.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Kasch', 'Affiliation': 'Department of Clinical Medicine, Health, Aarhus University, Aarhus.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000877']
1460,33181658,Comparison of locking plates and intramedullary nails in treatment of three-part or four-part proximal humeral neck fractures in elderly population: A randomized trial protocol.,"BACKGROUND
Locking plate and intramedullary nail are two commonly applied methods to fix proximal humeral fractures. There are limited randomized studies that specifically evaluate the results of proximal humeral neck fractures with three-part or four-part treated by locking plates or intramedullary nails. Our goal was to compare functional outcomes, complications, and imaging features between the two groups.
METHODS
This single-center, prospective, randomized controlled test will be conducted in Tengzhou Central People's Hospital. Patients with these conditions will be included: age between 55 and 80 years; are able to communicate normally and agree to participate in our study; with the radiological evidence of proximal humeral fractures with three-part or four-part; surgical treatment was performed within twenty-one days after the acute fracture. Consecutive patients with proximal humeral fractures will be stochastic to be dealt with a locking plate or a bone nail. The informed consent will be acquired in each patients. Two groups will use the same postoperative rehabilitation protocol. Clinical outcomes include Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications. The significance level was defaulted as P < .05.
RESULTS
This study will provide a solid theoretical basis for exploring which technique is better in treatment of 3-part or 4-part proximal humeral neck fractures in elderly population.
TRIAL REGISTRATION
This study protocol was registered in Research Registry (number: researchregistry6047).",2020,"Clinical outcomes include Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications.","['three-part or four-part proximal humeral neck fractures in elderly population', 'Consecutive patients with proximal humeral fractures', 'Patients with these conditions will be included: age between 55 and 80 years', ""Tengzhou Central People's Hospital"", '3-part or 4-part proximal humeral neck fractures in elderly population']","['locking plates or intramedullary nails', 'Locking plate and intramedullary nail', 'locking plate or a bone nail', 'locking plates and intramedullary nails']","['Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications', 'functional outcomes, complications, and imaging features', 'proximal humeral neck fractures']","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0262414', 'cui_str': 'Fracture of cervical spine'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0175718', 'cui_str': 'Bone pin'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0262414', 'cui_str': 'Fracture of cervical spine'}]",,0.0615174,"Clinical outcomes include Intraoperative blood loss, operation time, Constant-Murley score, Disability, Arm, Shoulder and Hand score, shoulder range of motion (such as external rotation), and postoperative complications.","[{'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'School of Medicine, Shandong University.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics, Tengzhou Central People's Hospital.""}, {'ForeName': 'Hongyang', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': ""Department of Orthopaedics, Tengzhou Central People's Hospital.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Department of Orthopaedics, Shandong Provincial Hospital Affiliated to Shandong University, Shandong, China.'}]",Medicine,['10.1097/MD.0000000000022914']
1461,33181659,"Efficacy and safety of Hominis placenta pharmacopuncture on mild cognitive impairment: Randomized, double blind, placebo-controlled, multi-center trial.","INTRODUCTION
Mild cognitive impairment (MCI) is cognitive decline which can be observed in a wide range of cognitive domains. It is considered as a prodromal stage of dementia; therefore, strategies for treatment are necessary, but current evidence is limited. Combining the memory enhancing effect of Hominis placenta (H placenta) and acupuncture elucidated separately in previous studies, efficacy of H placenta pharmacopuncture for treating MCI is anticipated.
METHODS
Thirty participants will be recruited. Male and female adults aged 50 to 80 who voluntarily participate in the trial, are diagnosed with MCI according to diagnostic and statistical manual of mental disorders-5 criteria, and have a Clinical Dementia Rating score 0.5 will be enrolled. Participants who meet the criteria will be randomly allocated to either pharmacopuncture group or control group. Participants will undergo H placenta pharmacopuncture or saline pharmacopuncture in GV20, ST36, and CV12 twice weekly for 8 weeks and will be evaluated a month after the last treatment. Primary outcome will be difference in mean change of Korean version of Montreal Cognitive Assessment scores between intervention group and control group. Cognition, mood, sleep quality and quality of life will be also assessed using other neuropsychological tests and questionnaires regarding depression, anxiety, sleep and quality of life.
DISCUSSION
Evaluating the efficacy and safety data obtained by assessing diverse aspects of patients with MCI will broaden the scope of MCI management and prevention of dementia progression.
TRIAL REGISTRATION
Clinical Research Information Service (KCT0005368), Registered 02 Sep 2020, https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16425.",2020,"Participants will undergo H placenta pharmacopuncture or saline pharmacopuncture in GV20, ST36, and CV12 twice weekly for 8 weeks and will be evaluated a month after the last treatment.","['Thirty participants will be recruited', 'Male and female adults aged 50 to 80 who voluntarily participate in the trial, are diagnosed with MCI according to diagnostic and statistical manual of mental disorders-5 criteria, and have a Clinical Dementia Rating score 0.5 will be enrolled', 'mild cognitive impairment', 'patients with MCI']","['pharmacopuncture group or control group', 'placebo', 'Hominis placenta (H placenta', 'Hominis placenta pharmacopuncture']","['mean change of Korean version of Montreal Cognitive Assessment scores', 'neuropsychological tests and questionnaires regarding depression, anxiety, sleep and quality of life', 'Efficacy and safety', 'Cognition, mood, sleep quality and quality of life']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4304227', 'cui_str': 'CDR (Clinical Dementia Rating) score'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4279921', 'cui_str': 'Pharmacopuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458975', 'cui_str': 'Hominy'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",30.0,0.230275,"Participants will undergo H placenta pharmacopuncture or saline pharmacopuncture in GV20, ST36, and CV12 twice weekly for 8 weeks and will be evaluated a month after the last treatment.","[{'ForeName': 'Yunna', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'College of Korean Medicine.'}, {'ForeName': 'Jae Hyok', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Neuropsychiatry, College of Korean Medicine, Semyung University.'}, {'ForeName': 'In Chul', 'Initials': 'IC', 'LastName': 'Jung', 'Affiliation': 'Department of Oriental Neuropsychiatry, College of Korean Medicine, Daejeon University.'}, {'ForeName': 'Yoon Ji', 'Initials': 'YJ', 'LastName': 'Eom', 'Affiliation': 'College of Korean Medicine.'}, {'ForeName': 'Seung-Hun', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'College of Korean Medicine.'}]",Medicine,['10.1097/MD.0000000000022956']
1462,33181664,Acupoint injection versus sacral canal injection in lumbar disc herniation: A protocol of randomized controlled trial.,"BACKGROUND
Both acupoint injection and sacral canal injection are widely adopted in the treatment of lumbar disc herniation (LDH), but there are still doubts about the effectiveness and safety of the 2 methods. Therefore, the objective of the randomized controlled trial is to evaluate the effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH.
METHOD
This is a prospective randomized controlled trial to study the effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH. With the approval by the clinical research ethics committee of our hospital, patients were randomly included into 1 of 2 treatment protocols:Patients, doctors, nurses, and research assistants responsible for collecting data were blinded to group allocation. Main outcome observation indicator: visual analogue scale; secondary outcome observation indicator: Oswestry disability index scores; paresthesia score; adverse reactions. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).
DISCUSSION
The effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH were evaluated in this study, and the results of this trial would establish clinical evidence for the adoption of acupoint injection or sacral canal injection to treat LDH.
TRIAL REGISTRATION NUMBER
DOI 10.17605 / OSF.IO / VTFUD.",2020,"The effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH were evaluated in this study, and the results of this trial would establish clinical evidence for the adoption of acupoint injection or sacral canal injection to treat LDH.
","['lumbar disc herniation (LDH', 'lumbar disc herniation']","['Acupoint injection versus sacral canal injection', 'acupoint injection and sacral canal injection']","['disability index scores; paresthesia score; adverse reactions', 'effectiveness and safety']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0223605', 'cui_str': 'Sacral canal'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.176183,"The effectiveness and safety of acupoint injection and sacral canal injection in the treatment of LDH were evaluated in this study, and the results of this trial would establish clinical evidence for the adoption of acupoint injection or sacral canal injection to treat LDH.
","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""The People's Hospital of Dazu District, Dazu, Chongqing, China.""}, {'ForeName': 'Huaying', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Yaokai', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000023000']
1463,33181672,Intelligent rehabilitation assistant system to promote the early functional recovery of the elderly patients with femoral neck fracture after hemiarthroplasty (HA): A protocol for a randomized controlled trial.,"BACKGROUND
Femoral neck fracture is a common type of hip fracture, which has a high morbidity and mortality. Surgical treatment is the first choice. However, the functional rehabilitation after operation has not been paid enough attention. In addition, the quality of exercise is difficult to quantify, and the rehabilitation is lack of standards. Therefore, the intelligent rehabilitation assistant system which could record exercise details, might be used to evaluate the quality and adherence to the prescribed exercise to this fragile group of patients has great relevance, so as to provide new ideas for postoperative rehabilitation of hip fracture.
METHODS
This is an opening, prospective, double-dummy RCT. Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA, will be invited to study. The sample will be divided into monitoring group and control group randomly at a 1:1 ratio. The prescribed exercises need to be done continuously for 2 weeks. The monitoring group needs additional use intelligent rehabilitation assistant system. Each subject will receive a total of 4 follow-up visits at the designated time (2 weeks, 4 weeks, 12 weeks, and 24 weeks). The following factors will be talked as dependent variables:Each subject will receive a total of 4 follow-up visits at the designated time, and the findings will be analyzed statistically considering a 5% significance level (P < .05).
DISCUSSION
Exercise under monitor may improve patients compliance and exercise quality, and accelerate the rehabilitation process. This protocol reported in accordance with the CONSORT 2010 checklist and SPIRIT 2013 Checklist.
TRIAL REGISTRATION
The trial is registered at Chinese Clinical Trials Registry (ChiCTR2000033213, May 24, 2020).",2020,"Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA, will be invited to study.","['elderly patients with femoral neck fracture after hemiarthroplasty (HA', 'Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA']",['Intelligent rehabilitation assistant system'],['patients compliance and exercise quality'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3874886', 'cui_str': 'Is about'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",50.0,0.070336,"Fifty femoral neck fractures patients, older than 65 years and are about to hospitalize for HA, will be invited to study.","[{'ForeName': 'Zige', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Haixiong', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine.'}, {'ForeName': 'Minling', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Junming', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'The First School of Clinical Medicine.'}, {'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, People's Republic of China.""}]",Medicine,['10.1097/MD.0000000000023078']
1464,33197659,The Buteyko breathing technique in children with asthma: a randomized controlled pilot study.,"BACKGROUND
Evidence supports the Buteyko breathing technique (BBT) as reducing medication and improving control and quality of life in adults with asthma, but having minimal impact on spirometry. For children with asthma, evidence addressing the utility of BBT is sparse. We evaluated the effectiveness of BBT in managing various aspects of asthma in children.
METHODS
Thirty-two children with partly controlled asthma (age 6-15 years, 66% male) were randomized to either Treatment as Usual (TAU) or TAU combined with Buteyko training (Buteyko group, BG). Children in the BG received an intensive five-day training followed by three months of home practice. Primary outcome was bronchodilator reduction. Secondary outcomes were changes in physiological parameters FEV1_AR (at rest), FEV1_ER (after ergometry), FEV1_BR (after bronchospasmolysis), corticosteroid use, FeNO, SpO2, breath-hold test and questionnaire data [Asthma Control Questionnaire and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)]. All measures were collected at Baseline and a three-month follow-up.
RESULTS
For the primary outcome, no significant between-group difference was found. Regarding the secondary outcomes, children receiving treatment augmented with BBT revealed significantly greater improvement at the follow-up than those receiving TAU for FEV1_AR (p = .04, d=-0.50), FEV1_ER (p = .02, d=-0.52), and the emotional function subscale of the PACQLQ (p < .01, d = 1.03). No between-group differences were found for the remaining secondary measures of outcome.
CONCLUSIONS
Our preliminary findings suggest that the addition of BBT to treatment as usual for children with asthma enhances outcomes with respect to spirometry and parental emotional function but does not lead to reductions in medication, at least over the short term.",2020,"No between-group differences were found for the remaining secondary measures of outcome.
","['asthma in children', 'children with asthma', 'Thirty-two children with partly controlled asthma (age 6-15 years, 66% male', 'adults with asthma']","['Buteyko breathing technique (BBT', 'Usual (TAU) or TAU combined with Buteyko training (Buteyko group, BG', 'Buteyko breathing technique', 'BBT']","['emotional function subscale of the PACQLQ', ""changes in physiological parameters FEV1_AR (at rest), FEV1_ER (after ergometry), FEV1_BR (after bronchospasmolysis), corticosteroid use, FeNO, SpO2, breath-hold test and questionnaire data [Asthma Control Questionnaire and Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ"", 'bronchodilator reduction']","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",32.0,0.0982378,"No between-group differences were found for the remaining secondary measures of outcome.
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vagedes', 'Affiliation': ""ARCIM Institute, Filderstadt, Germany; Department of Pediatrics, Filderklinik, Filderstadt, Germany; Department of Neonatology, Children's Hospital, University of Tübingen, Tübingen, Germany. Electronic address: j.vagedes@arcim-institute.de.""}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Helmert', 'Affiliation': 'ARCIM Institute, Filderstadt, Germany.'}, {'ForeName': 'Silja', 'Initials': 'S', 'LastName': 'Kuderer', 'Affiliation': 'ARCIM Institute, Filderstadt, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Vagedes', 'Affiliation': 'ARCIM Institute, Filderstadt, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Wildhaber', 'Affiliation': 'Department of Pediatrics, Fribourg Hospital HFR, Fribourg, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Andrasik', 'Affiliation': 'Department of Psychology, University of Memphis, Memphis, TN, USA.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102582']
1465,33197662,"The Effects of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy: An Open Label Quasi-Randomized Controlled Pilot Study.","OBJECTIVES
The current study evaluated the effects of peppermint oil on the frequency of nausea, vomiting, retching, and the severity of nausea in cancer patients undergoing chemotherapy.
DESIGN
A quasi-randomized controlled study.
SETTING
Patients were recruited from the ambulatory chemotherapy unit of a public hospital located (Batman, Turkey) between September 2017 and September 2018.
INTERVENTIONS
The participants in the intervention group applied one drop the aromatic mixture on the spot between their upper lip and their nose, three times a day for the five days following chemotherapy administration, in addition to the routine antiemetic treatment. Participants in the control group underwent only the routine antiemetic treatment. Main outcome measures VAS-the severity of nausea and the Index of Nausea, Vomiting, and Retching.
RESULTS
The VAS nausea score was significantly lower after peppermint oil applying in the patients receiving Folfirinox (treatment effect (mean dif.): 4.00±2.28; P<0.001), Paclitaxel-Trastuzumab (treatment effect (mean dif.): 1.70±0.90; P=0.014), Carboplatin-Paclitaxel (treatment effect (mean dif.): 3.71±1.41; P<0.001), and Cyclophosphamide-Adriamycin (treatment effect (mean dif.): 1.41±0.73; P=0.005) excluding cisplatin scedule (treatment effect (mean dif.): 0.56±2,18; P=0.642). We detected a statistical significant difference in the change in frequency of nausea, vomiting, retching in the other all schedules excluding cisplatin schedule (P<0.05).
CONCLUSIONS
The peppermint oil was significantly reduced the frequency of nausea, vomiting, retching and the severity of nausea in cancer patients undergoing chemotherapy. Therefore, usage of peppermint oil together with antiemetics after chemotherapy with moderate and low emetic risk may be recommended to cope with CINV.",2020,"The peppermint oil was significantly reduced the frequency of nausea, vomiting, retching and the severity of nausea in cancer patients undergoing chemotherapy.","['Cancer Patients', 'cancer patients undergoing chemotherapy', 'Patients were recruited from the ambulatory chemotherapy unit of a public hospital located (Batman, Turkey) between September 2017 and September 2018']","['Undergoing Chemotherapy', 'Carboplatin-Paclitaxel', 'Peppermint Oil', 'Cyclophosphamide-Adriamycin', 'Paclitaxel-Trastuzumab', 'peppermint oil']","['frequency of nausea, vomiting, retching, and the severity of nausea', 'Nausea, Vomiting and Retching', 'frequency of nausea, vomiting, retching', 'VAS-the severity of nausea and the Index of Nausea, Vomiting, and Retching', 'frequency of nausea, vomiting, retching and the severity of nausea', 'VAS nausea score']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1276154', 'cui_str': 'Ambulatory chemotherapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0402655', 'cui_str': 'Batman'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0070325', 'cui_str': 'Peppermint oil'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085752', 'cui_str': 'Adriamycin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0232602', 'cui_str': 'Retching'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0297702,"The peppermint oil was significantly reduced the frequency of nausea, vomiting, retching and the severity of nausea in cancer patients undergoing chemotherapy.","[{'ForeName': 'Nuriye', 'Initials': 'N', 'LastName': 'Efe Ertürk', 'Affiliation': 'Department of Nursing, Batman University Health College, Batman, Turkey. Electronic address: nuriye_efe@hotmail.com.'}, {'ForeName': 'Sultan', 'Initials': 'S', 'LastName': 'Taşcı', 'Affiliation': 'Department of Internal Medicine Nursing, Erciyes University Faculty of Health Science, Kayseri, Turkey.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102587']
1466,33197676,Wet-cupping induces anti-inflammatory action in response to vigorous exercise among martial arts athletes: A pilot study.,"PURPOSE
The aim of the present study was to investigate potential anti-inflammatory effects of wet-cupping prior to a moderate-to-vigorous exercise test among martial arts athletes.
METHODS
Twenty-one male karate athletes voluntarily participated in this study and were randomly divided into 3 groups: vigorous exercise (VE, n = 7), cupping (CT, n = 7) and cupping plus vigorous exercise (VECT, n = 7). Participants in exercise groups performed an exercise test while participants in CT received cupping therapy, and participants in VECT received cupping therapy plus exercise. Inflammatory markers (i.e., interlukin-6, IL-6, and tumor necrosis factor-α, TNF-α) were assessed prior to, immediately, 30 min, and 24 h after cupping therapy, vigorous exercise test, and their combination.
RESULTS
IL-6 values were significantly lower immediately after cupping intervention in CT as compared to baseline (P < 0.025). IL-6 significantly increased immediately and 30 min post-exercise in VE in comparison with baseline (P < 0.025). IL-6 was also significantly higher at 24 h post-exercise in CTVE as compared to baseline (P < 0.025). TNF-α values were significantly lower in CT as compared to VE and CTVE at immediately and 30 min post-exercise (P < 0.01). TNF-α significantly decreased immediately and 30 min after cupping intervention in CT as compared to baseline (P < 0.01). Conversely, TNF-α significantly increased immediately after exercise in VE as compared to baseline (P < 0.025). TNF-α also significantly increased at 30 min and 24 h post-exercise in CTVE in comparison with baseline (P < 0.025).
CONCLUSION
Our findings showed that exercise-induced augmentation in inflammatory markers were lower in athletes who received cupping therapy, suggesting such therapy may be an avenue to mitigate the inflammatory response to vigorous exercise among martial arts athletes. A large-scale clinical study is needed to confirm the findings of the present study.",2020,TNF-α values were significantly lower in CT as compared to VE and CTVE at immediately and 30 min post-exercise (P < 0.01).,"['Twenty-one male karate athletes voluntarily participated', 'martial arts athletes']","['cupping therapy', 'wet-cupping prior to a moderate-to-vigorous exercise test', 'vigorous exercise (VE, n = 7), cupping (CT, n = 7) and cupping plus vigorous exercise (VECT', 'Wet-cupping', 'TNF-α', 'exercise test while participants in CT received cupping therapy, and participants in VECT received cupping therapy plus exercise']","['Inflammatory markers (i.e., interlukin-6, IL-6, and tumor necrosis factor-α, TNF-α', 'IL-6 values', 'IL-6', 'TNF-α values', 'TNF-α']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0079654', 'cui_str': 'Karate'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0079801', 'cui_str': 'Martial arts'}]","[{'cui': 'C5197695', 'cui_str': 'Cupping Treatment'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",21.0,0.0327562,TNF-α values were significantly lower in CT as compared to VE and CTVE at immediately and 30 min post-exercise (P < 0.01).,"[{'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Ekrami', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, University of Shahid Beheshti, Tehran, Iran. Electronic address: narges.ekrami@gmail.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ahmadian', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nourshahi', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, University of Shahid Beheshti, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Shakouri G', 'Affiliation': 'School of Industrial and Systems Engineering, University of Tehran, Tehran, Iran.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102611']
1467,33197677,Effects of a mind-body program on symptoms of depression and perceived stress among adults with neurofibromatosis type 2 who are deaf: A live-video randomized controlled trial.,"INTRODUCTION
Neurofibromatosis type 2 (NF2) is a rare, progressive and incurable genetic disorder associated with progressive hearing loss and eventual deafness. As a group, patients with NF report high levels of stress and depressive symptoms. However, no studies have explored improvement in these symptoms after psychosocial interventions. We have previously shown that a mind-body program tailored to adults with NF2 who are deaf (the Relaxation Response and Resiliency Program for Deaf NF2, d3RP-NF2) improves quality of life and resiliency over and above a Health Enhancement program when both are delivered via live-video and assisted by Communication Access Realtime Translation (CART). Here we tested the effects of the programs on depression and perceived stress.
METHODS
Forty-five patients with NF2 and significant hearing loss were randomized to the d3RP-NF2 or Health-Enhancement program and completed measures of depression (PHQ-9) and perceived stress (PSS-10) at baseline, post-intervention, and six-month follow-up.
RESULTS
Patients randomized to the d3RP-NF2 program, but not to the control condition, experienced significant decreases on both measures from baseline to post-test, which were maintained at follow-up (within group tests). However, improvements following the d3RP-NF2 program was not significantly higher than those observed in the control group (between group tests).
CONCLUSION
Results provide the first evidence of improvement in symptoms of depression and perceived stress among deaf patients living with NF2 who participate in a virtual mind-body program.",2020,"However, improvements following the d3RP-NF2 program was not significantly higher than those observed in the control group (between group tests).
","['Forty-five patients with NF2 and significant hearing loss', 'adults with neurofibromatosis type 2 who are deaf']","['mind-body program', 'd3RP-NF2 or Health-Enhancement program and completed measures of depression (PHQ-9) and perceived stress (PSS-10) at baseline, post-intervention, and six-month follow-up']","['depression and perceived stress', 'stress and depressive symptoms', 'symptoms of depression and perceived stress']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",45.0,0.0320809,"However, improvements following the d3RP-NF2 program was not significantly higher than those observed in the control group (between group tests).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Carter', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, USA; Harvard Medical School, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, USA; Harvard Medical School, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Funes', 'Affiliation': 'Division of Neuropsychiatry, Department of Psychiatry & Athinoula A Martinos Center for Biomedical Imaging, Massachusetts General Hospital, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, USA; Biostatistics Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Department of Psychiatry, Massachusetts General Hospital, USA; Harvard Medical School, USA. Electronic address: avranceanu@mgh.harvard.edu.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102581']
1468,33198319,Non-Linear Pharmacokinetics of Oral Roscovitine (Seliciclib) in Cystic Fibrosis Patients Chronically Infected with Pseudomonas aeruginosa : A Study on Population Pharmacokinetics with Monte Carlo Simulations.,"Roscovitine (Seliciclib), a new protein kinase inhibitor, was administered orally to adult patients with cystic fibrosis for the first time in the ROSCO-CF trial, a dose-escalation, phase IIa, randomized, controlled trial. Extensive pharmacokinetic sampling was performed up to 12 h after the first oral dose. Roscovitine and its main metabolite M3 were quantified by liquid chromatography coupled with tandem mass spectrometry. The pharmacokinetics analyses were performed by non-linear mixed effects modelling. Monte Carlo simulations were performed to assess the impact of dose on the pharmacokinetics of oral roscovitine. Twenty-three patients received oral doses ranging from 200 to 800 mg of roscovitine and 138 data points were available for both roscovitine and M3 concentrations. The pharmacokinetics was best described by a two-compartment parent-metabolite model, with a complex saturable absorption process modelled as the sum of Gaussian inverse density functions. The Monte Carlo simulations showed a dose-dependent and saturable first-pass effect leading to pre-systemic formation of M3. The treatment with proton-pump inhibitors reduced the rate of absorption of oral roscovitine. The pharmacokinetics of oral roscovitine in adult patients with cystic fibrosis was non-linear and showed significant inter-individual variability. A repeat-dose study will be required to assess the inter-occasional variability of its pharmacokinetics.",2020,The pharmacokinetics of oral roscovitine in adult patients with cystic fibrosis was non-linear and showed significant inter-individual variability.,"['Cystic Fibrosis Patients', 'adult patients with cystic fibrosis', 'Chronically Infected with Pseudomonas aeruginosa ']","['Roscovitine (Seliciclib', 'roscovitine', 'proton-pump inhibitors', 'Oral Roscovitine (Seliciclib', 'oral roscovitine']",['rate of absorption of oral roscovitine'],"[{'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}]","[{'cui': 'C0536217', 'cui_str': '(2R)-2-((6-Benzylamino-9-(propan-2-yl)-9H-purin-2-yl)amino)butan-1-ol'}, {'cui': 'C1609861', 'cui_str': 'Seliciclib'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0536217', 'cui_str': '(2R)-2-((6-Benzylamino-9-(propan-2-yl)-9H-purin-2-yl)amino)butan-1-ol'}]",,0.0295561,The pharmacokinetics of oral roscovitine in adult patients with cystic fibrosis was non-linear and showed significant inter-individual variability.,"[{'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Leven', 'Affiliation': 'EA 3878, GETBO, Université de Bretagne Occidentale, F-29200 Brest, France.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Schutz', 'Affiliation': 'Univ Brest, INSERM, EFS, UMR 1078, GGB, F-29200 Brest, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Audrezet', 'Affiliation': 'Univ Brest, INSERM, EFS, UMR 1078, GGB, F-29200 Brest, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Nowak', 'Affiliation': ""Centre d'Investigation Clinique, INSERM CIC-1412, Hôpital de la Cavale Blanche, CHRU Brest, 29609 Brest CEDEX, France.""}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Meijer', 'Affiliation': ""ManRos Therapeutics, Presqu'île de Perharidy, 29680 Roscoff, France.""}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Montier', 'Affiliation': 'Univ Brest, INSERM, EFS, UMR 1078, GGB, F-29200 Brest, France.'}]",Pharmaceutics,['10.3390/pharmaceutics12111087']
1469,33198568,"Gait Disturbance Improvement and Cerebral Cortex Rearrangement by Acupuncture in Parkinson's Disease: A Pilot Assessor-Blinded, Randomized, Controlled, Parallel-Group Trial.","BACKGROUND
Parkinson's disease (PD) leads to impaired mobility and limited independence.
OBJECTIVE
We investigated the effects of acupuncture on gait disturbance and analyzed hemodynamic changes caused by acupuncture in the cerebral cortex of patients with PD.
METHODS
Participants (n = 26) with gait disturbance due to PD were randomly assigned to the intervention (acupuncture twice a week for 4 weeks + conventional therapy) or control (conventional therapy) groups. We analyzed gait parameters using the GAITRite system and hemodynamic responses in the cerebral cortices using functional near-infrared spectroscopy, Unified Parkinson's Disease Rating Scale (UPDRS) scores, neurotransmitter levels, as well as the immediate effects of acupuncture in patients with PD.
RESULTS
The participants tended to walk with hypometric gait (high cadence, short steps) overground. After acupuncture treatment, those in the intervention group showed a significant reduction in cadence and the UPDRS scores involving ""walking and balance"" compared with those in the control group ( P = .004 and P = .020, respectively); the stride, swing, and single support times were significantly increased ( P = .006, P = .001, and P = .001, respectively). Oxyhemoglobin levels in the intervention group while walking on a treadmill were significantly increased in the prefrontal and supplementary motor areas. The oxyhemoglobin levels in the prefrontal cortex and swing time revealed significant positive correlations.
CONCLUSIONS
Our findings indicated that acupuncture tended to improve hypometric gait and rearranged activation of the cerebral cortex. Thus, acupuncture may be a useful complementary treatment for gait disturbance, including hypometric gait, in patients with PD. Trial Registration Number . Clinical Research Information Service (KCT0002603), https://cris.nih.go.kr/cris/index.jsp.",2020,Oxyhemoglobin levels in the intervention group while walking on a treadmill were significantly increased in the prefrontal and supplementary motor areas.,"[""Parkinson's Disease"", 'patients with PD.\nMETHODS\n\n\nParticipants (n = 26) with gait disturbance due to PD', 'patients with PD']","['Acupuncture', 'intervention (acupuncture twice a week for 4 weeks + conventional therapy) or control (conventional therapy', 'acupuncture']","['gait disturbance and analyzed hemodynamic changes', 'stride, swing, and single support times', 'Gait Disturbance Improvement and Cerebral Cortex Rearrangement', ""Parkinson's Disease Rating Scale (UPDRS) scores, neurotransmitter levels"", 'oxyhemoglobin levels', 'cadence and the UPDRS scores involving ""walking and balance', 'hypometric gait and rearranged activation of the cerebral cortex', 'Oxyhemoglobin levels']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007776', 'cui_str': 'Structure of cerebral cortex'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",26.0,0.0498053,Oxyhemoglobin levels in the intervention group while walking on a treadmill were significantly increased in the prefrontal and supplementary motor areas.,"[{'ForeName': 'Jung-Hee', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Sangsoo', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Jinung', 'Initials': 'J', 'LastName': 'An', 'Affiliation': 'Convergence Research Center for Wellness, Digist R4-814, Dalseong-Gun, Daegu, Republic of Korea.'}, {'ForeName': 'Jong-Duk', 'Initials': 'JD', 'LastName': 'Choi', 'Affiliation': 'College of Health & Medical Science, Graduate School, Daejeon City, Republic of Korea.'}, {'ForeName': 'In Chan', 'Initials': 'IC', 'LastName': 'Seol', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Gunhyuk', 'Initials': 'G', 'LastName': 'Park', 'Affiliation': 'Korea Institute of Oriental Medicine, Naju-si, Jeollanam-do, Republic of Korea.'}, {'ForeName': 'Seung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Korea University, Seongbuk-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'College of Health & Medical Science, Graduate School, Daejeon City, Republic of Korea.'}, {'ForeName': 'Weechang', 'Initials': 'W', 'LastName': 'Kang', 'Affiliation': 'Daejeon University, Dong-gu, Daejeon City, Republic of Korea.'}, {'ForeName': 'Eun-Sun', 'Initials': 'ES', 'LastName': 'Jung', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Ji-Yun', 'Initials': 'JY', 'LastName': 'Cha', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Chan-Young', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Siyeon', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'In Chul', 'Initials': 'IC', 'LastName': 'Jung', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Horyong', 'Initials': 'H', 'LastName': 'Yoo', 'Affiliation': 'Dunsan Korean Medicine Hospital, Seo-gu, Daejeon, Republic of Korea.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320969942']
1470,33202093,"YH12852, a Potent and Selective Receptor Agonist of 5-hydroxytryptamine, Increased Gastrointestinal Motility in Healthy Volunteers and Patients With Functional Constipation.","Gastrointestinal (GI) motility disorders are common, decreases quality of life, and imposes a substantial economic burden. YH12852 is a novel agonist of 5-hydroxytryptamine for the treatment of GI motility disorders. This phase I/IIa study assessed the tolerability, pharmacodynamic (PD) and pharmacokinetic (PK) profiles of YH12852. In the multiple dose (MD) cohort, healthy subjects and patients with functional constipation were randomized and received orally YH12852 at 0.3, 0.5, 1, 2, or 3 mg or prucalopride 2 mg or their matching placebo, once daily for 14 days after breakfast. In the multiple low-dose cohort (MLD), healthy subjects randomly received once-daily oral doses of YH12852 at 0.05 or 0.1 mg for 14 days after breakfast. Questionnaires, gastric emptying breath test for PDs, and plasma samples for PKs were collected. In the MD cohort, a total of 56 subjects (29 healthy volunteers and 27 patients with functional constipation) were randomized, of whom 48 completed the study. In the MLD cohort, a total of 16 healthy subjects were randomized, and 15 subjects completed the study. YH12852 increased the average weekly frequency of spontaneous bowel movements and loosened the stool. In addition, YH12852 increased quality of life satisfaction, and decreased severity of constipation symptom and GI symptoms. YH12852 was safe and well-tolerated up to 3 mg and showed nearly dose proportional PKs. In conclusion, YH12852 was safe and enhanced GI motility. YH12852 can be developed as an effective treatment option for GI motility disorders, including functional constipation. Further studies are warranted to confirm this possibility.",2020,"In addition, YH12852 increased quality of life satisfaction, and decreased severity of constipation symptom and gastrointestinal symptoms.","['Healthy Volunteers and Patients with Functional Constipation', 'GI motility disorders', '16 healthy subjects were randomized, and 15 subjects completed the study', 'healthy subjects and patients with functional constipation', '56 subjects (29 healthy volunteers and 27 patients with functional constipation']","['5-hydroxytryptamine', 'prucalopride 2 mg or their matching placebo']","['quality of life satisfaction', 'severity of constipation symptom and gastrointestinal symptoms', 'Gastrointestinal Motility', 'tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) profiles of YH12852', 'average weekly frequency of spontaneous bowel movements and loosened the stool', 'safe and well-tolerated', 'Questionnaires, gastric emptying breath test (GEBT) for PD, and plasma samples for PK', 'safe and enhanced gastrointestinal motility']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0854121', 'cui_str': 'Gastrointestinal motility disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4745453', 'cui_str': 'prucalopride 2 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0017184', 'cui_str': 'Gastrointestinal Motility'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4706161', 'cui_str': 'YH12852'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}]",16.0,0.031208,"In addition, YH12852 increased quality of life satisfaction, and decreased severity of constipation symptom and gastrointestinal symptoms.","[{'ForeName': 'Hyun A', 'Initials': 'HA', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Seol Ju', 'Initials': 'SJ', 'LastName': 'Moon', 'Affiliation': 'Center for Clinical Pharmacology, Biomedical Research Institute, Chonbuk National University Hospital, Jeonju, Korea.'}, {'ForeName': 'Hyounggyoon', 'Initials': 'H', 'LastName': 'Yoo', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Department, Research & Development Division, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Seong Bok', 'Initials': 'SB', 'LastName': 'Jang', 'Affiliation': 'Clinical Development Department, Research & Development Division, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Seoungoh', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Clinical Development Department, Research & Development Division, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Sohee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Department, Research & Development Division, Yuhan Corporation, Seoul, Korea.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.'}]",Clinical and translational science,['10.1111/cts.12924']
1471,33202559,Evaluation of the Combination of Muscle Energy Technique and Trigger Point Therapy in Asymptomatic Individuals with a Latent Trigger Point.,"(1) Background: The aim of the study was to determine the effect of the combination therapy of Muscle Energy Technique (MET) and Trigger Point Therapy (TPT) on the angular values of the range of movements of the cervical spine and on the pressure pain threshold (PPT) of the trapezius muscle in asymptomatic individuals. METHODS: The study involved 60 right-handed, asymptomatic students with a latent trigger point in the upper trapezius muscle. All qualified volunteers practiced amateur symmetrical sports. The study used a tensometric electrogoniometer (cervical spine movement values) and an algometer (pressure pain threshold (PPT) of upper trapezius). Randomly (sampling frame), volunteers were assigned to three different research groups (MET + TPT, MET and TPT). All participants received only one therapeutic intervention. Measurements were taken in three time-intervals (pre, post and follow-up the next day after therapy). (2) Results: One-time combined therapy (MET + TPT) significantly increases the range of motion occurring in all planes of the cervical spine. One-time treatments of single MET and single TPT therapy selectively affect the mobility of the cervical spine. The value of the PPT significantly increased immediately after all therapies, but only on the right trapezius muscle, while on the left side only after the therapy combining MET with TPT. (3) Conclusion: The MET + TPT method proved to be the most effective, as it caused changes in all examined goniometric and subjective parameters.",2020,"The value of the PPT significantly increased immediately after all therapies, but only on the right trapezius muscle, while on the left side only after the therapy combining MET with TPT.","['asymptomatic individuals', 'Asymptomatic Individuals with a Latent Trigger Point', '60 right-handed, asymptomatic students with a latent trigger point in the upper trapezius muscle']","['Muscle Energy Technique and Trigger Point Therapy', 'One-time combined therapy (MET + TPT', 'Muscle Energy Technique (MET) and Trigger Point Therapy (TPT', 'TPT therapy', 'tensometric electrogoniometer (cervical spine movement values) and an algometer (pressure pain threshold (PPT) of upper trapezius']",['mobility of the cervical spine'],"[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}]","[{'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}]",60.0,0.0153653,"The value of the PPT significantly increased immediately after all therapies, but only on the right trapezius muscle, while on the left side only after the therapy combining MET with TPT.","[{'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Wendt', 'Affiliation': 'Department of Biology and Anatomy, Poznan University of Physical Education, 61-871 Poznań, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Waszak', 'Affiliation': 'Department of Biology and Anatomy, Poznan University of Physical Education, 61-871 Poznań, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17228430']
1472,33202607,Effect of a Mediterranean Diet-Based Nutritional Intervention on the Risk of Developing Gestational Diabetes Mellitus and Other Maternal-Fetal Adverse Events in Hispanic Women Residents in Spain.,"Gestational diabetes mellitus (GDM) is the most frequent morbidity found in pregnancy, and it increases the risk for several maternal-fetal complications. Hispanic women are considered at high risk. The St. Carlos GDM prevention study is a randomized controlled trial (RCT) conducted from 2016-2017. Normoglycemic women were randomized at 12-14 Gestation week (WG) to an intervention group (IG) receiving recommendations based on the MedDiet (supplemented with ExtraVirgin Olive Oil/pistachios), or to a control group (CG), recommended to limit fat intake. After RCT conclusion, IG recommendations were applied to a real-world group (RW) in routine clinical practice. The primary endpoint of the current study is an assessment of the GDM rate in Hispanic participants of the aforementioned studies: 132 RCT, 128 CT, 284 RW participants. The GDM rate was lower in IG: 19/128(14.8%), p = 0.021, and RW: 38/284(13.4%), p = 0.029) than in CG: 34/132(25.8%). Adjusted RR (95%CI) for GDM: 0.72 (0.50-0.97), p = 0.037 in IG and 0.77 (0.61-0.97), p = 0.008 in RW. Rates of urinary tract infections, emergency caesarean-sections and perineal trauma were also lower in IG and RW. Other adverse outcomes were lower in IG vs. CG. In conclusion, a MedDiet-based intervention reduces the rate of GDM and several adverse maternal-fetal outcomes in Hispanic women residing in Spain.",2020,"The GDM rate was lower in IG: 19/128(14.8%), p = 0.021, and RW: 38/284(13.4%), p = 0.029) than in CG: 34/132(25.8%).","['Normoglycemic women', 'Gestational diabetes mellitus (GDM', 'Hispanic Women Residents in Spain', 'Hispanic participants of the aforementioned studies: 132 RCT, 128 CT, 284 RW participants', 'Hispanic women residing in Spain', 'Hispanic women']","['Mediterranean Diet-Based Nutritional Intervention', 'intervention group (IG) receiving recommendations based on the MedDiet (supplemented with ExtraVirgin Olive Oil/pistachios), or to a control group (CG']","['Rates of urinary tract infections, emergency caesarean-sections and perineal trauma', 'Risk of Developing Gestational Diabetes Mellitus', 'GDM rate', 'rate of GDM and several adverse maternal-fetal outcomes']","[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0459819', 'cui_str': 'Pistachio nut'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0558380', 'cui_str': 'Emergency cesarean section'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0826849,"The GDM rate was lower in IG: 19/128(14.8%), p = 0.021, and RW: 38/284(13.4%), p = 0.029) than in CG: 34/132(25.8%).","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Melero', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'García de la Torre', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Assaf-Balut', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Jiménez', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Del Valle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Durán', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bordiú', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Johanna J', 'Initials': 'JJ', 'LastName': 'Valerio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Herraiz', 'Affiliation': 'Medicina 2 Department, Facultad de Medicina, Universidad Complutense de Madrid, E 28040 Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Izquierdo', 'Affiliation': 'Medicina 2 Department, Facultad de Medicina, Universidad Complutense de Madrid, E 28040 Madrid, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Torrejón', 'Affiliation': 'Clinical Laboratory Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Runkle', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barabash', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Rubio', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}, {'ForeName': 'Alfonso L', 'Initials': 'AL', 'LastName': 'Calle-Pascual', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínico Universitario San Carlos and Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), E 28040 Madrid, Spain.'}]",Nutrients,['10.3390/nu12113505']
1473,33202719,Influence of Probiotics on the Salivary Microflora Oral Streptococci and Their Integration into Oral Biofilm.,"Probiotics' ability to integrate into dental biofilms is not yet clarified. The aim of this trial was to detect probiotic bacteria from probiotic products in dental biofilm and saliva during and after intake. In this parallel, randomized clinical trial, 39 subjects wore customized appliances to build up intra-oral biofilms (72-h periods). The trial was divided into screening (S) to determine baseline biofilm flora, intervention (I), and wash out (WO). During I (28 days), subjects consumed a product containing (a) Enterococcus faecalis (b) Lactobacillus casei , or (c) Lactobacillus rhamnosus GG. Probiotic bacteria and Streptococci spp. were detected in the biofilms and saliva of the 35 subjects that were included in the analysis. During I and WO, the ratio of probiotics in the biofilm was very low compared to total bacterial load, while saliva had slightly but not significantly higher values. No significant changes of probiotic bacteria ( p > 0.05) were found at any visit during I or WO. The proportion of streptococci was significantly reduced ( p < 0.05) during I and even lower in WO, compared to S. Probiotic bacteria could neither integrate nor persist in dental biofilm and saliva but did influence the growth of streptococci in biofilm and saliva.",2020,"The proportion of streptococci was significantly reduced ( p < 0.05) during I and even lower in WO, compared to S. Probiotic bacteria could neither integrate nor persist in dental biofilm and saliva but did influence the growth of streptococci in biofilm and saliva.","['39 subjects wore customized appliances to build up intra-oral biofilms (72-h periods', '35 subjects that were included in the analysis']","['subjects consumed a product containing (a) Enterococcus faecalis (b) Lactobacillus casei , or (c) Lactobacillus rhamnosus GG']","['probiotic bacteria', 'proportion of streptococci']","[{'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",39.0,0.0542296,"The proportion of streptococci was significantly reduced ( p < 0.05) during I and even lower in WO, compared to S. Probiotic bacteria could neither integrate nor persist in dental biofilm and saliva but did influence the growth of streptococci in biofilm and saliva.","[{'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Arweiler', 'Affiliation': 'Department of Periodontology and Peri-Implant Diseases, Philipps-University, 35039 Marburg, Germany.'}, {'ForeName': 'Thorsten M', 'Initials': 'TM', 'LastName': 'Auschill', 'Affiliation': 'Department of Periodontology and Peri-Implant Diseases, Philipps-University, 35039 Marburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Heumann', 'Affiliation': 'Department of Statistics, Ludwig-Maximilians University, 80539 Munich, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Hellwig', 'Affiliation': 'Department of Operative Dentistry & Periodontology, Center for Dental Medicine, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': 'Department of Operative Dentistry & Periodontology, Center for Dental Medicine, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9110803']
1474,33202825,Efficacy and Toxicity of Different Chemotherapy Protocols for Concurrent Chemoradiation in Non-Small Cell Lung Cancer-A Secondary Analysis of the PET Plan Trial.,"(1) Background: The optimal chemotherapy (CHT) regimen for concurrent chemoradiation (cCRT) is not well defined. In this secondary analysis of the international randomized PET-Plan trial, we evaluate the efficacy of different CHT. (2) Methods: Patients with inoperable NSCLC were randomized at a 1:1 ratio regarding the target volume definition and received isotoxically dose-escalated cCRT using cisplatin 80 mg/m 2 (day 1, 22) and vinorelbin 15 mg/m 2 (day 1, 8, 22, 29) (P1) or cisplatin 20 mg/m 2 (day 1-5, 29-33) and vinorelbin 12.5 mg/m 2 (day 1, 8, 15, 29, 36, 43) (P2) or carboplatin AUC1 (day 1-5, 29-33) and vinorelbin 12.5 mg/m 2 (day 1, 8, 15, 29, 36, 43) (P3) or other CHT at the treating physician's discretion. (3) Results: Between 05/2009 and 11/2016, 205 patients were randomized and 172 included in the per-protocol analysis. Patients treated in P1 or P2 had a better overall survival (OS) compared to P3 ( p = 0.015, p = 0.01, respectively). Patients treated with carboplatin had a worse OS compared to cisplatin (HR 1.78, p = 0.03), but the difference did not remain significant after adjusting for age, ECOG, cardiac function creatinine and completeness of CHT. (4) Conclusions: Carboplatin doublets show no significant difference compared to cisplatin, after adjusting for possibly relevant factors, probably due to existing selection bias.",2020,"Patients treated with carboplatin had a worse OS compared to cisplatin (HR 1.78, p = 0.03), but the difference did not remain significant after adjusting for age, ECOG, cardiac function creatinine and completeness of CHT.","['205 patients were randomized and 172 included in the per-protocol analysis', 'Patients with inoperable NSCLC']","['cisplatin', 'vinorelbin', 'carboplatin', 'cCRT using cisplatin', 'carboplatin AUC1', 'chemotherapy (CHT) regimen for concurrent chemoradiation (cCRT']","['overall survival (OS', 'ECOG, cardiac function creatinine and completeness of CHT', 'Efficacy and Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",205.0,0.219451,"Patients treated with carboplatin had a worse OS compared to cisplatin (HR 1.78, p = 0.03), but the difference did not remain significant after adjusting for age, ECOG, cardiac function creatinine and completeness of CHT.","[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Gkika', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Lenz', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Schimek-Jasch', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Cornelius F', 'Initials': 'CF', 'LastName': 'Waller', 'Affiliation': 'Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kremp', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Schaefer-Schuler', 'Affiliation': 'Department of Nuclear Medicine, Saarland University Medical Center and Faculty of Medicine, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mix', 'Affiliation': 'Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Küsters', 'Affiliation': 'Department of Radiation Oncology, Kliniken Maria Hilf, 41063 Mönchengladbach, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tosch', 'Affiliation': 'Department of Nuclear Medicine, Helios University Hospital Wuppertal, 42283 Wuppertal, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hehr', 'Affiliation': 'Department of Radiation Oncology, Marienhospital, 70199 Stuttgart, Germany.'}, {'ForeName': 'Susanne Martina', 'Initials': 'SM', 'LastName': 'Eschmann', 'Affiliation': 'Department of Nuclear Medicine, Marienhospital, 70199 Stuttgart, Germany.'}, {'ForeName': 'Yves-Pierre', 'Initials': 'YP', 'LastName': 'Bultel', 'Affiliation': 'Department of Radiation Oncology, Klinikum Mutterhaus der Boromäerinnen, 54290 Trier, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hass', 'Affiliation': 'Department of Radiation Oncology, University Hospital Magdeburg, 39120 Magdeburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Fleckenstein', 'Affiliation': 'Department of Radiotherapy and Radiation Oncology, Saarland University Medical Center and Faculty of Medicine, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Alexander Henry', 'Initials': 'AH', 'LastName': 'Thieme', 'Affiliation': 'Department of Radiation Oncology, Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Stockinger', 'Affiliation': 'Department of Radiation Oncology, University Hospital Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Dieckmann', 'Affiliation': 'Department of Radiotherapy, Vienna General Hospital, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Miederer', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Holl', 'Affiliation': 'Department of Nuclear Medicine, Kliniken Schwerin, 19055 Schwerin, Germany.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Rischke', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Adebahr', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Institute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Hospital of Mainz, 55131 Mainz, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Binder', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Anca-Ligia', 'Initials': 'AL', 'LastName': 'Grosu', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Nestle', 'Affiliation': 'Department of Radiation Oncology, Medical Center-University of Freiburg, Robert-Koch-Str. 3, 79106 Freiburg, Germany.'}]",Cancers,['10.3390/cancers12113359']
1475,33202849,Boosting Psychological Well-Being through a Social Mindfulness-Based Intervention in the General Population.,"The benefits of mindfulness meditation among clinical and non-clinical populations have been largely reported in literature. Existing mindfulness-based programs are particularly useful in targeting specific populations while researchers have pointed out the possibility of developing programs adapted to the audience and the context. In this two-groups pre-post experimental design we developed a mindfulness-based social intervention program to target individuals from the general population. Here we present a two-groups pre-post experimental design to investigate its effectiveness on participants' psychological functioning assessed by eight self-reported questionnaires (CORE-OM, FFMQ, SWLS, PANAS, PSS, SCS, WEMWBS, SHS) which encompass different domains of well-being, mindfulness and emotional functioning. Participants, recruited on voluntary basis, were randomly allocated to treated or passive control groups and were aware of group allocation. The intervention comprises a 12-week meditation training in a big group that represents the social aspect of meditation. Data were analysed via a linear mixed effect model and intention to treat. Statistically significant results were obtained for global score of CORE-OM (β = -0.20 [-0.30; -0.10], p = 0.0002), FFMQ (β = 0.20 [0.12; -0.28], p < 0.0001), SWLS (β = 1.43 [0.42; 2.45], p = 0.006), positive PANAS (β = 1.99 [0.95; 3.04], p = 0.0002), negative PANAS (β = -1.67 [-2.92; -0.43], p = 0.009), PSS (β = -2.98 [-4.25; -1.71], p < 0.0001), WEMWBS (β = 4.38 [2.93; 5.83], p < 0.0001) and SHS (β = 1.43 [0.42; 2.45], p = 0.006). Our intervention is causally associated with an improvement of the psychological functioning and hence can be considered as a preventive measure that may potentially reduce the risk of developing psychological problems and improve the subject's general well-being. Given the voluntary recruitment, our inference only applies to those individuals who have decided to experience meditation as a way to well-being and not to a random person from the general population.",2020,"Statistically significant results were obtained for global score of CORE-OM (β = -0.20 [-0.30; -0.10], p = 0.0002), FFMQ (β = 0.20 [0.12; -0.28], p < 0.0001), SWLS (β = 1.43 [0.42; 2.45], ","['Participants, recruited on voluntary basis']","['mindfulness-based social intervention program', 'mindfulness meditation', 'meditation training']","['global score of CORE-OM', 'FFMQ', ""participants' psychological functioning assessed by eight self-reported questionnaires (CORE-OM, FFMQ, SWLS, PANAS, PSS, SCS, WEMWBS, SHS""]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0796135', 'cui_str': 'Renpenning syndrome'}]",,0.0334232,"Statistically significant results were obtained for global score of CORE-OM (β = -0.20 [-0.30; -0.10], p = 0.0002), FFMQ (β = 0.20 [0.12; -0.28], p < 0.0001), SWLS (β = 1.43 [0.42; 2.45], ","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Fazia', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bubbico', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Salvato', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Berzuini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Bruno', 'Affiliation': 'Istituto di Psicosintesi, 20124 Milano, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Bottini', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Bernardinelli', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, 27100 Pavia, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17228404']
1476,33203027,Fruit and Vegetable Lesson Plan Pilot Intervention for Grade 5 Students from Southwestern Ontario.,"The purpose was to create and assess the impact of food literacy curriculum alongside a centrally procured school snack program among grade five students in Southwestern Ontario, Canada. Grade five students ( N = 287) from five intervention and three controls schools participated in an 8-week food delivery program. In addition to the food delivery program, intervention schools received a resource kit and access to 42 multidisciplinary food literacy lesson plans using the produce delivered as part of the food delivery program. Participants completed matched pre- and post-test online surveys to assess fruit and vegetable intake, knowledge, preferences, and attitudes. Descriptive analyses and changes in scores between the intervention and control schools were assessed using one-way ANOVAs, paired samples t -tests, and McNemar's tests. In total, there were 220 participants that completed both the pre- and post-test surveys. There was a significant improvement in fruit and vegetable intake ( p = 0.038), yet no differences in knowledge of the recommended number of food group servings, knowledge of food groups, or fruit and vegetable preferences or attitudes were observed. Integrating nutrition lesson plans within core curricula classes (e.g., math, science, and literacy) can lead to modest increases in fruit and vegetable intake.",2020,"There was a significant improvement in fruit and vegetable intake ( p = 0.038), yet no differences in knowledge of the recommended number of food group servings, knowledge of food groups, or fruit and vegetable preferences or attitudes were observed.","['220 participants that completed both the pre- and post-test surveys', 'grade five students in Southwestern Ontario, Canada', 'Grade five students ( N = 287) from five intervention and three controls schools participated in an 8-week food delivery program', 'Grade 5 Students from Southwestern Ontario']","['food literacy curriculum alongside a centrally procured school snack program', 'Fruit and Vegetable Lesson Plan Pilot Intervention']","['fruit and vegetable intake', 'knowledge of food groups, or fruit and vegetable preferences or attitudes']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0163109,"There was a significant improvement in fruit and vegetable intake ( p = 0.038), yet no differences in knowledge of the recommended number of food group servings, knowledge of food groups, or fruit and vegetable preferences or attitudes were observed.","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Woodruff', 'Affiliation': 'Department of Kinesiology, University of Windsor, Windsor, ON N9B 3P4, Canada.'}, {'ForeName': 'Clinton', 'Initials': 'C', 'LastName': 'Beckford', 'Affiliation': 'Faculty of Education, University of Windsor, Windsor, ON N9B 3P4, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Segave', 'Affiliation': 'Ontario Student Nutrition Program-Southwestern, Windsor, ON N8W 5C2, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17228422']
1477,33203047,Information Recall in Pre-Operative Consultation for Glioma Surgery Using Actual Size Three-Dimensional Models.,"Three-dimensional (3D) technologies are being used for patient education. For glioma, a personalized 3D model can show the patient specific tumor and eloquent areas. We aim to compare the amount of information that is understood and can be recalled after a pre-operative consult using a 3D model (physically printed or in Augmented Reality (AR)) versus two-dimensional (2D) MR images. In this explorative study, healthy individuals were eligible to participate. Sixty-one participants were enrolled and assigned to either the 2D (MRI/fMRI), 3D (physical 3D model) or AR groups. After undergoing a mock pre-operative consultation for low-grade glioma surgery, participants completed two assessments (one week apart) testing information recall using a standardized questionnaire. The 3D group obtained the highest recall scores on both assessments (Cohen's d = 1.76 and Cohen's d = 0.94, respectively, compared to 2D), followed by AR and 2D, respectively. Thus, real-size 3D models appear to improve information recall as compared to MR images in a pre-operative consultation for glioma cases. Future clinical studies should measure the efficacy of using real-size 3D models in actual neurosurgery patients.",2020,"The 3D group obtained the highest recall scores on both assessments (Cohen's d = 1.76 and Cohen's d = 0.94, respectively, compared to 2D), followed by AR and 2D, respectively.","['Sixty-one participants were enrolled and assigned to either the 2D (MRI/fMRI), 3D (physical 3D model) or AR groups', 'healthy individuals were eligible to participate', 'Glioma Surgery', 'actual neurosurgery patients']",[],['highest recall scores'],"[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0269568,"The 3D group obtained the highest recall scores on both assessments (Cohen's d = 1.76 and Cohen's d = 0.94, respectively, compared to 2D), followed by AR and 2D, respectively.","[{'ForeName': 'Sümeyye', 'Initials': 'S', 'LastName': 'Sezer', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Vitoria', 'Initials': 'V', 'LastName': 'Piai', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Roy P C', 'Initials': 'RPC', 'LastName': 'Kessels', 'Affiliation': 'Department of Medical Psychology, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ter Laan', 'Affiliation': 'Department of Neurosurgery, Radboud University Medical Center, 6525 GA Nijmegen, The Netherlands.'}]",Journal of clinical medicine,['10.3390/jcm9113660']
1478,33203167,Full Versus Trophic Feeds in Critically Ill Adults with High and Low Nutritional Risk Scores: A Randomized Controlled Trial.,"Although energy intake might be associated with clinical outcomes in critically ill patients, it remains unclear whether full or trophic feeding is suitable for critically ill patients with high or low nutrition risk. We conducted a prospective study to determine which feeding energy intakes were associated with clinical outcomes in critically ill patients with high or low nutrition risk. This was an investigator-initiated, single center, single blind, randomized controlled trial. Critically ill patients were allocated to either high or low nutrition risk based on their Nutrition Risk in the Critically Ill score, and then randomized to receive either the full or the trophic feeding. The feeding procedure was administered for six days. No significant differences were observed in in-hospital, 14-day and 28-day mortalities, the length of ventilator dependency, or ICU and hospital stay among the four groups. There were no associations between energy and protein intakes and in-hospital, 14-day and 28-day mortalities in any of the four groups. However, protein intake was positively associated with the length of hospital stay and ventilator dependency in patients with low nutrition risk receiving trophic feeding. Full or trophic feeding in critically ill patients showed no associations with clinical outcomes, regardless of nutrition risk.",2020,"There were no associations between energy and protein intakes and in-hospital, 14-day and 28-day mortalities in any of the four groups.","['critically ill patients with high or low nutrition risk', 'Critically ill patients', 'Critically Ill Adults with High and Low Nutritional Risk Scores', 'patients with low nutrition risk receiving trophic feeding', 'critically ill patients']","['Full Versus Trophic Feeds', 'high or low nutrition risk based on their Nutrition Risk']","['hospital, 14-day and 28-day mortalities, the length of ventilator dependency, or ICU and hospital stay', 'energy and protein intakes and in-hospital, 14-day and 28-day mortalities', 'length of hospital stay and ventilator dependency']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0548431,"There were no associations between energy and protein intakes and in-hospital, 14-day and 28-day mortalities in any of the four groups.","[{'ForeName': 'Chen-Yu', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Critical Care Medicine, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Pin-Kuei', 'Initials': 'PK', 'LastName': 'Fu', 'Affiliation': 'Department of Critical Care Medicine, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Wen-Cheng', 'Initials': 'WC', 'LastName': 'Chao', 'Affiliation': 'Department of Critical Care Medicine, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Wei-Ning', 'Initials': 'WN', 'LastName': 'Wang', 'Affiliation': 'Department of Food and Nutrition, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Chao-Hsiu', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Food and Nutrition, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 40201, Taiwan.'}]",Nutrients,['10.3390/nu12113518']
1479,33203458,Approaches to cervical spine mobilization for neck pain: a pilot randomized controlled trial.,"STUDY DESIGN
Pilot randomized controlled trial.
BACKGROUND
Better understanding of the relative effectiveness of different approaches to cervical spine mobilization has been identified as a research priority in manual therapy practice. Two distinct approaches to the practice of mobilization have emerged in recent years, based on different reasoning models for selection of mobilization techniques. The objective of this pilot study was to assess feasibility aspects for a future randomized clinical trial by exploring short-term pain and disability outcomes after a single treatment with pragmatic versus prescriptive approaches to cervical mobilization for people with recent-onset neck pain at 48-h follow-up after randomization.
METHODS
Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups. The pragmatic group received a single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist. The prescriptive group received a single treatment of standardized mobilization with techniques similar to a previous mobilization clinical trial. Feasibility outcomes were recruitment rates, randomization audit and completion of treatment and follow-up per protocol. The primary clinical outcome of interest was disability level measured at 48-h follow-up after randomization.
RESULTS
Recruitment rates were approximately 2.5 participants per week and 100% of eligible participants were deemed suitable for treatment with cervical mobilization. There was sufficient variety in the range of pragmatic treatments selected and the data collection process imposed minimal burden on participants.
CONCLUSIONS
Our results provide supporting evidence for the feasibility of a future larger scale randomized clinical trial.
TRIAL REGISTRATION
Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12616000446460). Registered 6th April 2016. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true.",2020,"METHODS
Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups.","['people with recent-onset neck pain at 48-h follow-up after randomization', 'Twenty adults with a new episode of mechanical neck pain', 'neck pain']","['cervical spine mobilization', 'single treatment of cervical mobilization with the technique, target segment, and grade selected by their treating therapist', 'https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370448&isReview=true', 'pragmatic or prescriptive mobilization intervention']","['recruitment rates, randomization audit and completion of treatment and follow-up per protocol', 'disability level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0565959', 'cui_str': 'New episode'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}]","[{'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",20.0,0.317113,"METHODS
Twenty adults with a new episode of mechanical neck pain were randomly allocated to either pragmatic or prescriptive mobilization intervention groups.","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Lagoutaris', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Sullivan', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hancock', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Leaver', 'Affiliation': 'The University of Sydney, Faculty of Medicine and Health, Sydney, NSW, 2006, Australia. andrew.leaver@sydney.edu.au.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00348-z']
1480,33203627,Methotrexate and prednisolone study in erythema nodosum leprosum (MaPs in ENL) protocol: a double-blind randomised clinical trial.,"INTRODUCTION
Erythema nodosum leprosum (ENL) is an immunological complication of leprosy. ENL results in morbidity and disability and if it is not treated can lead to death. The current treatment consists of thalidomide or high doses of oral corticosteroids for prolonged periods. Thalidomide is not available in many leprosy endemic countries. The use of corticosteroids is associated with morbidity and mortality. Identifying treatment regimens that reduce the use of corticosteroids in ENL is essential. Methotrexate (MTX) is used to treat many inflammatory diseases and has been used successfully to treat patients with ENL not controlled by other drugs, including prednisolone and thalidomide. We present the protocol of the 'MTX and prednisolone study in ENL' (MaPs in ENL) a randomised controlled trial (RCT) designed to test the efficacy of MTX in the management of ENL.
METHODS AND ANALYSIS
MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal. Patients diagnosed with ENL who consent to participate will be randomly allocated to receive 48 weeks of weekly oral MTX plus 20 weeks of prednisolone or 48 weeks of placebo plus 20 weeks of prednisolone. Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL. The primary objective is to determine whether MTX reduces the requirement for additional prednisolone. Patients' reported outcome measures will be used to assess the efficacy of MTX. Participants will be closely monitored for adverse events.
ETHICS AND DISSEMINATION
Results will be submitted for publication in peer-reviewed journals. Ethical approval was obtained from the Observational/Interventions Research Ethics Committee of the London School of Hygiene & Tropical Medicine (15762); The Leprosy Mission International Bangladesh Institutional Research Board (in process); AHRI-ALERT Ethical Review Committee, Ethiopia; Ethics Committee of the Managing Committee of the Bombay Leprosy Project; and The Leprosy Mission Trust India Ethics Committee; the Nepal Health and Research Council and Health Research Ethics Committee Dr. Soetomo, Indonesia. This study is registered at www.clinicaltrials.gov. This is the first RCT of MTX for ENL and will contribute to the evidence for the management of ENL.Trial registration numberNCT 03775460.",2020,"METHODS AND ANALYSIS
MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal.","['Patients diagnosed with ENL who consent to participate', 'leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal', 'Participants will be stratified by type of ENL into those with acute ENL and those with chronic and recurrent ENL']","['Methotrexate and prednisolone', 'Methotrexate (MTX', 'Thalidomide', 'MTX', 'prednisolone and thalidomide', 'thalidomide', 'placebo', 'MTX and prednisolone', 'oral corticosteroids', 'prednisolone']","['efficacy of MTX', 'morbidity and mortality', 'morbidity and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0343466', 'cui_str': 'Type 2 lepra reaction'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0023343', 'cui_str': 'Leprosy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1265576', 'cui_str': 'Acute erythema'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.414145,"METHODS AND ANALYSIS
MaPs in ENL is an international multicentre RCT, which will be conducted in leprosy referral centres in Bangladesh, Brazil, Ethiopia, India, Indonesia and Nepal.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'de Barros', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK barbara.de-barros@lshtm.ac.uk.'}, {'ForeName': 'Saba M', 'Initials': 'SM', 'LastName': 'Lambert', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Shah', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Vivek V', 'Initials': 'VV', 'LastName': 'Pai', 'Affiliation': 'Bombay Leprosy Project, Mumbai, India.'}, {'ForeName': 'Joydeepa', 'Initials': 'J', 'LastName': 'Darlong', 'Affiliation': 'The Leprosy Mission Trust India, New Delhi, Indonesia.'}, {'ForeName': 'Benjamin Jewel', 'Initials': 'BJ', 'LastName': 'Rozario', 'Affiliation': 'DBLM Hospital, The Leprosy Mission International Bangladesh, Nilphamari, Bangladesh.'}, {'ForeName': 'Medhi Denisa', 'Initials': 'MD', 'LastName': 'Alinda', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Airlangga, Dr Soetomo General Hospital, Surabaya, Jawa Timur, Indonesia.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Sales', 'Affiliation': 'Leprosy Laboratory, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Shimelis', 'Initials': 'S', 'LastName': 'Doni', 'Affiliation': 'Clinical Research Department, ALERT Center, Addis Ababa, London, Ethiopia.'}, {'ForeName': 'Deanna A', 'Initials': 'DA', 'LastName': 'Hagge', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Shrestha', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'M Yulianto', 'Initials': 'MY', 'LastName': 'Listiawan', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Airlangga, Dr Soetomo General Hospital, Surabaya, Jawa Timur, Indonesia.'}, {'ForeName': 'Abeba M', 'Initials': 'AM', 'LastName': 'Yitaye', 'Affiliation': 'Clinical Research Department, ALERT Center, Addis Ababa, London, Ethiopia.'}, {'ForeName': 'Jose A C', 'Initials': 'JAC', 'LastName': 'Nery', 'Affiliation': 'Leprosy Laboratory, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Kapil D', 'Initials': 'KD', 'LastName': 'Neupane', 'Affiliation': 'Department of Dermatology and Mycobacterial Research Laboratories, The Leprosy Mission Nepal, Anandaban Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Vivianne L A', 'Initials': 'VLA', 'LastName': 'Dias', 'Affiliation': 'Leprosy Laboratory, Instituto Oswaldo Cruz, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'C Ruth', 'Initials': 'CR', 'LastName': 'Butlin', 'Affiliation': 'DBLM Hospital, The Leprosy Mission International Bangladesh, Nilphamari, Bangladesh.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Nicholls', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lockwood', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Walker', 'Affiliation': 'Clinical Research Department, London School of Hygiene & Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037700']
1481,33203685,Completion rate and impact on physician-patient relationship of video consultations in medical oncology: a randomised controlled open-label trial.,"BACKGROUND
Mobile phone video call applications generally did not undergo testing in randomised controlled clinical trials prior to their implementation in patient care regarding the rate of successful patient visits and impact on the physician-patient relationship.
METHODS
The National Center for Tumour Diseases (NCT) MOBILE trial was a monocentric open-label randomised controlled clinical trial of patients with solid tumours undergoing systemic cancer therapy with need of a follow-up visit with their consulting physician at outpatient clinics. 66 patients were 1:1 randomised to receive either a standard in-person follow-up visit at outpatient clinics or a video call via a mobile phone application. The primary outcome was feasibility defined as the proportion of patients successfully completing the first follow-up visit. Secondary outcomes included success rate of further video calls, time spent by patient and physician, patient satisfaction and quality of physician-patient relationship.
FINDINGS
Success rate of the first follow-up visit in the intention-to-treat cohort was 87.9% (29 of 33) for in-person visits and 78.8% (26 of 33) for video calls (relative risk: RR 0.90, 95% CI 0.70 to 1.13, p=0.51). The most common reasons for failure were software incompatibility in the video call and no-show in the in-person visit arm. The success rate for further video visits was 91.7% (11 of 12). Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86). Physician-patient relationship quality mean scores assessed by a validated standardised questionnaire were higher in the video call arm (1.13-fold, p=0.02).
INTERPRETATION
Follow-up visits with the tested mobile phone video call application were feasible but software compatibility should be critically evaluated.
TRIAL REGISTRATION NUMBER
DRKS00015788.",2020,"Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86).","['medical oncology', '66 patients', 'patients with solid tumours undergoing systemic cancer therapy with need of a follow-up visit with their consulting physician at outpatient clinics', 'The National Center for Tumour Diseases (NCT']",['standard in-person follow-up visit at outpatient clinics or a video call via a mobile phone application'],"['success rate of further video calls, time spent by patient and physician, patient satisfaction and quality of physician-patient relationship', 'feasibility defined as the proportion of patients successfully completing the first follow-up visit', 'success rate for further video visits', 'total time spent and less direct costs']","[{'cui': 'C0025098', 'cui_str': 'Medical oncology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",66.0,0.20894,"Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Walle', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany t.walle@dkfz-heidelberg.de.'}, {'ForeName': 'Erkin', 'Initials': 'E', 'LastName': 'Erdal', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Mühlsteffen', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Hans Martin', 'Initials': 'HM', 'LastName': 'Singh', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Editha', 'Initials': 'E', 'LastName': 'Gnutzmann', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Grün', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Hofmann', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Ivanova', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Bruno Christian', 'Initials': 'BC', 'LastName': 'Köhler', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Korell', 'Affiliation': 'Department of Hematology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Mavratzas', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Mock', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Constantin', 'Initials': 'C', 'LastName': 'Pixberg', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schult', 'Affiliation': 'Department of Hematology, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Starke', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Steinebrunner', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Woydack', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Dietrich', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Jäger', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Krisam', 'Affiliation': 'Institute of Medical Biometry and Informatics, University Hospital Heidelberg, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Jakob N', 'Initials': 'JN', 'LastName': 'Kather', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Eva C', 'Initials': 'EC', 'LastName': 'Winkler', 'Affiliation': 'Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg, Germany.'}]",ESMO open,['10.1136/esmoopen-2020-000912']
1482,33203708,Comparison of active versus passive surveillance adverse event reporting in a paediatric ambulatory chiropractic care setting: a cluster randomised controlled trial.,"OBJECTIVES
This pragmatic, cluster, stratified randomised controlled trial (RCT) compared the quantity and quality of adverse event (AE) reports after chiropractic manual therapy in children less than 14 years of age, using active versus passive surveillance reporting systems.
METHOD
Data were collected between November 2014 and July 2017 from 60 consecutive paediatric patient visits to participating chiropractors. Those allocated to active surveillance collected AE information with three paper-based questionnaires (two from patients, one from chiropractors) to identify any new or worsening symptoms after treatment. Passive surveillance involved AE information reported by chiropractors on a web-based system. To assess quality of reporting, AE reports greater than mild were reviewed by content experts. The primary outcome was the cumulative incidence of AE reports in active versus passive surveillance.
RESULTS
Ninety-six chiropractors agreed to participate and enrolled in the study: 34 chiropractors in active surveillance with 1894 patient visits from 1179 unique patients and 35 chiropractors in passive surveillance with 1992 patient visits from 1363 unique patients. In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001). The quality of AE reports was not evaluated because the five AE reports reviewed by the content experts were determined to be of mild severity.
CONCLUSION
We found that active surveillance resulted in significantly more AE reports than passive surveillance. Further prospective active surveillance research studies should be conducted with children receiving chiropractic manual therapy to understand mechanisms and risk factors for moderate and severe AEs, and to further explore how and when to solicit patient safety information.",2020,"In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001).","['Data were collected between November 2014 and July 2017 from 60 consecutive paediatric patient visits to participating chiropractors', 'paediatric ambulatory chiropractic care setting', 'children less than 14 years of age, using active versus passive surveillance reporting systems', 'Ninety-six chiropractors agreed to participate and enrolled in the study: 34 chiropractors in active surveillance with 1894 patient visits from 1179 unique patients and 35 chiropractors in passive surveillance with 1992 patient visits from 1363 unique patients', 'children receiving']",['chiropractic manual therapy'],"['cumulative incidence of AE reports in active versus passive surveillance', 'quantity and quality of adverse event (AE']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334952', 'cui_str': 'Chiropractor'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0456592', 'cui_str': '1992'}]","[{'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.15357,"In the active arm, AEs were reported in 8.8% (n=140, 95% CI 6.72% to 11.18%) of patients/caregivers, compared with 0.1% (n=2, 95% CI 0.02% to 0.53%) in the passive arm (p<0.001).","[{'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Pohlman', 'Affiliation': 'Research Center, Parker University, Dallas, Texas, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Carroll', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Ross T', 'Initials': 'RT', 'LastName': 'Tsuyuki', 'Affiliation': 'Department of Pharmacology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartling', 'Affiliation': 'Department of Paediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Vohra', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada svohra@ualberta.ca.'}]",BMJ open quality,['10.1136/bmjoq-2020-000972']
1483,33204834,Improving Resident Self-Efficacy in Tracheostomy Management Using a Novel Curriculum.,"Introduction
Patients receiving pediatric tracheostomy have significant risk for mortality due to compromised airway. Timely management of airway emergencies in children with tracheostomies is an important clinical skill for pediatricians. We developed this curriculum to improve residents' self-efficacy with tracheostomy management.
Methods
We collected baseline data on 67 residents from two hospitals while creating a blended curriculum with video-based instruction on routine tracheostomy change and team management of tracheostomy emergency. Forty residents enrolled in the curriculum. During an ICU rotation, they received face-to-face instruction on routine tracheostomy change in small groups, followed by assessment of managing a tracheostomy emergency during a simulation. A video completed prior to the simulation took 9 minutes, the routine tracheostomy change didactic session took 15 minutes, and the simulation instruction was completed in 10-15 minutes. We collected feedback on the effectiveness of the curriculum from the participants.
Results
All 107 residents from the baseline and intervention groups completed the self-efficacy survey. The intervention group had significantly higher changes in scores across all self-efficacy domains than the baseline group. On the curriculum feedback survey, residents rated the curriculum very highly, between 4.4 and 4.8 on a 5-point Likert scale.
Discussion
Our blended curriculum increased learners' self-efficacy and promoted learner competence in tracheostomy management. Residents scored more than 80% across all aspects of simulation assessment and reported higher self-efficacy scores following our curricular intervention.",2020,Residents scored more than 80% across all aspects of simulation assessment and reported higher self-efficacy scores following our curricular intervention.,"['67 residents from two hospitals while creating a', 'children with tracheostomies', 'Forty residents enrolled in the curriculum', 'All 107 residents from the baseline and intervention groups completed the self-efficacy survey']","['pediatric tracheostomy', 'blended curriculum with video-based instruction on routine tracheostomy change and team management of tracheostomy emergency']","['self-efficacy scores', 'learner competence', ""learners' self-efficacy""]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0184635', 'cui_str': 'Tracheostomy care'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",40.0,0.0414925,Residents scored more than 80% across all aspects of simulation assessment and reported higher self-efficacy scores following our curricular intervention.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Benjamin', 'Affiliation': ""Assistant Professor, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Roy', 'Affiliation': ""Medical Director-TICU, Baylor College of Medicine and Texas Children's Hospital; Assistant Professor of Pediatrics, Department of Pediatric ICU, Texas Children's Hospital and Baylor College of Medicine.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Paul', 'Affiliation': ""Assistant Professor, Department of Pulmonology, Nationwide Children's Hospital and the Ohio State University College of Medicine.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': ""Instructor, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Charles', 'Affiliation': ""Nurse Practitioner, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Nurse Practitioner, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Narsi-Prasla', 'Affiliation': ""Nurse Practitioner, Department of Otolaryngology, Baylor College of Medicine and Texas Children's Hospital.""}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Mahan', 'Affiliation': ""Associate Director, Center for Faculty Advancement, Mentoring and Engagement (FAME), the Ohio State University College of Medicine; Professor, Department of Pediatrics, Nationwide Children's Hospital and the Ohio State University College of Medicine; Program Director, Pediatric Nephrology Fellowship Programs, Nationwide Children's Hospital and the Ohio State University College of Medicine.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thammasitboon', 'Affiliation': ""Associate Professor and Director, Center for Research, Innovation and Scholarship (CRIS) in Medical Education, Baylor College of Medicine and Texas Children's Hospital.""}]",MedEdPORTAL : the journal of teaching and learning resources,['10.15766/mep_2374-8265.11010']
1484,33205810,SGLT2 inhibition versus sulfonylurea treatment effects on electrolyte and acid-base balance: secondary analysis of a clinical trial reaching glycemic equipoise: Tubular effects of SGLT2 inhibition in Type 2 diabetes.,"Sodium-glucose transporter (SGLT)2 inhibitors increase plasma magnesium and plasma phosphate and may cause ketoacidosis, but the contribution of improved glycemic control to these observations as well as effects on other electrolytes and acid-base parameters remain unknown. Therefore, our objective was to compare the effects of SGLT2 inhibitors dapagliflozin and sulfonylurea gliclazide on plasma electrolytes, urinary electrolyte excretion, and acid-base balance in people with Type 2 diabetes (T2D). We assessed the effects of dapagliflozin and gliclazide treatment on plasma electrolytes and bicarbonate, 24-hour urinary pH and excretions of electrolytes, ammonium, citrate, and sulfate in 44 metformin-treated people with T2D and preserved kidney function. Compared with gliclazide, dapagliflozin increased plasma chloride by 1.4 mmol/l (95% CI 0.4-2.4), plasma magnesium by 0.03 mmol/l (95% CI 0.01-0.06), and plasma sulfate by 0.02 mmol/l (95% CI 0.01-0.04). Compared with baseline, dapagliflozin also significantly increased plasma phosphate, but the same trend was observed with gliclazide. From baseline to week 12, dapagliflozin increased the urinary excretion of citrate by 0.93 ± 1.72 mmol/day, acetoacetate by 48 μmol/day (IQR 17-138), and β-hydroxybutyrate by 59 μmol/day (IQR 0-336), without disturbing acid-base balance. In conclusion, dapagliflozin increases plasma magnesium, chloride, and sulfate compared with gliclazide, while reaching similar glucose-lowering in people with T2D. Dapagliflozin also increases urinary ketone excretion without changing acid-base balance. Therefore, the increase in urinary citrate excretion by dapagliflozin may reflect an effect on cellular metabolism including the tricarboxylic acid cycle. This potentially contributes to kidney protection.",2020,"From baseline to week 12, dapagliflozin increased the urinary excretion of citrate by 0.93 ± 1.72 mmol/day, acetoacetate by 48 µmol/day (IQR -17 to 138), and β-hydroxybutyrate by 59 µmol/day (IQR 0 to 336), without disturbing acid-base balance.","['people with type 2 diabetes (T2D', '44 metformin-treated people with T2D and preserved kidney function']","['gliclazide', 'SGLT2 inhibitors', 'sulfonylurea', 'gliclazide, dapagliflozin', 'Dapagliflozin', 'SGLT2 inhibitors dapagliflozin and sulfonylurea gliclazide', 'dapagliflozin and gliclazide', 'dapagliflozin']","['plasma sulfate', 'urinary citrate excretion', 'plasma chloride', 'plasma electrolytes and bicarbonate, 24-hour urinary pH and excretions of electrolytes, ammonium, citrate, and sulfate', 'urinary excretion of citrate', 'plasma magnesium', 'plasma electrolytes, urinary electrolyte excretion, and acid-base balance', 'plasma phosphate', 'urinary ketone excretion']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]","[{'cui': 'C0017631', 'cui_str': 'Gliclazide'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0858097', 'cui_str': 'Plasma chloride'}, {'cui': 'C0858120', 'cui_str': 'Plasma electrolytes NOS'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0858137', 'cui_str': 'Plasma magnesium'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0858147', 'cui_str': 'Plasma phosphate'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}]",,0.14678,"From baseline to week 12, dapagliflozin increased the urinary excretion of citrate by 0.93 ± 1.72 mmol/day, acetoacetate by 48 µmol/day (IQR -17 to 138), and β-hydroxybutyrate by 59 µmol/day (IQR 0 to 336), without disturbing acid-base balance.","[{'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Geurts', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Marcel H A', 'Initials': 'MHA', 'LastName': 'Muskiet', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Post', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, The Netherlands.'}, {'ForeName': 'Stephan J L', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, University of Groningen, The Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Division of Pharmacology and Vascular Medicine, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Daan J', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'van Berkel', 'Affiliation': 'Department of Laboratory Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Mark H H', 'Initials': 'MHH', 'LastName': 'Kramer', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Location VUMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Ele', 'Initials': 'E', 'LastName': 'Ferrannini', 'Affiliation': 'CNR Institute of Clinical Physiology, Pisa, Italy.'}, {'ForeName': 'Jaap A', 'Initials': 'JA', 'LastName': 'Joles', 'Affiliation': 'Department of Nephrology and Hypertension, University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Ewout J', 'Initials': 'EJ', 'LastName': 'Hoorn', 'Affiliation': 'Division of Nephrology and Transplantation, Department of Internal Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, Location VUMC, Amsterdam, The Netherlands.'}]","Clinical science (London, England : 1979)",['10.1042/CS20201274']
1485,33160946,Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial.,"BACKGROUND
The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis.
METHODS/DESIGN
The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000,137-40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR.
SUMMARY
The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.",2020,"BACKGROUND
The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies.","['patients with severe symptomatic native aortic stenosis', '768 patients treated with TAVR via the transfemoral approach', 'patients with severe symptomatic aortic valve stenosis', 'patients with low operative risk']","['transcatheter aortic valve replacement (TAVR', 'balloon-expandable Myval transcatheter heart valve (THV', 'Myval transcatheter heart valve versus contemporary transcatheter heart valves', 'Myval THV series (n=384) or to contemporary THV']","['safety and efficacy', 'composite of all-cause mortality, all stroke (disabling and non-disabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0205549', 'cui_str': 'Series'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0336548', 'cui_str': 'Prosthetic valve'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.117538,"BACKGROUND
The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies.","[{'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Soliman', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Emeline', 'Initials': 'E', 'LastName': 'Zeller', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Ashokkumar', 'Initials': 'A', 'LastName': 'Thakkar', 'Affiliation': 'Meril Life Sciences Pvt. Ltd., India.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Tamburino', 'Affiliation': 'Ferrarotto Hospital, Policlinico Hospital and University of Catania, Catania, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bedogni', 'Affiliation': 'Department of Cardiology, IRCCS Pol. S. Donato, S. Donato Milanese, Milan, Italy.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': 'Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Department of Cardiology, Cardiovascular Institute Paris-Sud, Hopital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Webster', 'Affiliation': 'Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Rosseel', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mylotte', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baumbach', 'Affiliation': 'William Harvey Research Institute, Queen Mary University of London, and Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",American heart journal,['10.1016/j.ahj.2020.11.001']
1486,33166870,Testing a gamified Spider App to reduce spider fear and avoidance.,"Mobile applications are increasingly part of mental health programs and various apps have been developed for treating anxiety disorders. Typically, they aim to improve anxiety symptoms via established CBT techniques, such as exposure principles, which are considered extremely unpleasant for fearful individuals. We combined in a mobile application exposure principles with gamification elements (e.g. narrative background, level progression, points, and feedback). These elements should increase the motivation for confronting spider images and decrease the experienced distress. To evaluate the application, two groups of spider-fearful individuals played either the Spider App (experimental group) or a non-spider associated app (control group) twice a day for approximately 12 min for 7 days. After this week, participants of the experimental group showed less avoidance behavior of spiders (BAT), as well as lower anxiety of spiders (SPQ, FAS). Groups were not different in measures of depression or psychological distress. Interestingly, participants playing the Spider App reported higher anxiety, disgust and arousal ratings shortly after playing the app. However, anxiety, disgust, and arousal ratings decreased from day to day. We discuss our findings with respect to implications for the clinical practice.",2020,Groups were not different in measures of depression or psychological distress.,[],['Spider App (experimental group) or a non-spider associated app (control group) twice a day for approximately 12\u202fmin for 7 days'],"['spider fear and avoidance', 'anxiety, disgust, and arousal ratings', 'lower anxiety of spiders (SPQ, FAS', 'higher anxiety, disgust and arousal ratings', 'depression or psychological distress', 'avoidance behavior of spiders (BAT']",[],"[{'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0392331', 'cui_str': 'Arachnophobia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683283', 'cui_str': 'Disgust'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037913', 'cui_str': 'Order Araneae'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}]",,0.0157851,Groups were not different in measures of depression or psychological distress.,"[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Haberkamp', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: anke.haberkamp@staff.uni-maburg.de.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Walter', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: Walterha@students.uni-marburg.de.'}, {'ForeName': 'Phillipp', 'Initials': 'P', 'LastName': 'Althaus', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: Althausp@students.uni-marburg.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schmuck', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: Schmuckm@students.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Philipps-University, Marburg, Germany. Electronic address: rief@staff.uni-marburg.de.'}, {'ForeName': 'Filipp', 'Initials': 'F', 'LastName': 'Schmidt', 'Affiliation': 'Justus-Liebig-University, Giessen, Germany. Electronic address: Filipp.Schmidt@psychol.uni-giessen.de.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102331']
1487,31796805,Cortical neurodynamics changes mediate the efficacy of a personalized neuromodulation against multiple sclerosis fatigue.,"The people with multiple sclerosis (MS) often report that fatigue restricts their life. Nowadays, pharmacological treatments are poorly effective accompanied by relevant side effects. A 5-day transcranial direct current stimulation (tDCS) targeting the somatosensory representation of the whole body (S1) delivered through an electrode personalized based on the brain MRI was efficacious against MS fatigue (FaReMuS treatment). This proof of principle study tested whether possible changes of the functional organization of the primary sensorimotor network induced by FaReMuS partly explained the effected fatigue amelioration. We measured the brain activity at rest through electroencephalography equipped with a Functional Source Separation algorithm and we assessed the neurodynamics state of the primary somatosensory (S1) and motor (M1) cortices via the Fractal Dimension and their functional connectivity via the Mutual Information. The dynamics of the neuronal electric activity, more distorted in S1 than M1 before treatment, as well as the network connectivity, altered maximally between left and right M1 homologs, reverted to normal after FaReMuS. The intervention-related changes explained 48% of variance of fatigue reduction in the regression model. A personalized neuromodulation tuned in on specific anatomo-functional features of the impaired regions can be effective against fatigue.",2019,This proof of principle study tested whether possible changes of the functional organization of the primary sensorimotor network induced by FaReMuS partly explained the effected fatigue amelioration.,['people with multiple sclerosis (MS'],['5-day transcranial direct current stimulation (tDCS'],['brain activity'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity'}]",,0.0283027,This proof of principle study tested whether possible changes of the functional organization of the primary sensorimotor network induced by FaReMuS partly explained the effected fatigue amelioration.,"[{'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porcaro', 'Affiliation': ""LET'S - ISTC - CNR, Rome, Italy.""}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Cottone', 'Affiliation': ""LET'S - ISTC - CNR, Rome, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cancelli', 'Affiliation': ""LET'S - ISTC - CNR, Rome, Italy.""}, {'ForeName': 'Paolo M', 'Initials': 'PM', 'LastName': 'Rossini', 'Affiliation': 'Area di Neuroscienze, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Zito', 'Affiliation': ""LET'S - ISTC - CNR, Rome, Italy.""}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Tecchio', 'Affiliation': ""LET'S - ISTC - CNR, Rome, Italy. franca.tecchio@cnr.it.""}]",Scientific reports,['10.1038/s41598-019-54595-z']
1488,33171390,"Randomized controlled trial of community-based, post-rehabilitation exercise in COPD.","PURPOSE
Although pulmonary rehabilitation (PR) improves function in people with chronic obstructive pulmonary disease (COPD), a community-based exercise program may be necessary to maintain functional capacity. We aimed to determine the effectiveness of a post-rehabilitation, community-based maintenance program on exercise tolerance, functional capacity and quality of life.
METHODS
Patients with COPD who completed PR were randomized to receive a community-based maintenance program (intervention) or usual care (control). The primary outcome was 6-min walk distance (6MWD), measured immediately post-PR, 6 months and 12 months later. Secondary outcomes included self-reported functional capacity, health-related quality of life, self-efficacy, program cost, and lower extremity muscle strength.
RESULTS
Ninety-seven patients (69 ± 9 years) were enrolled. There was a non-significant trend of an intervention effect on 6MWD over time (β = 42, 95% CI: 0.06 to 83.93, p = 0.053). There was no significant impact of group on any of the secondary outcomes. Restricting the analysis to those who attended ≥50% of the exercise sessions showed a significant intervention effect for 6MWD (β = 69.19, 95% CI = 10.16 to 128.22, p = 0.03). The cost of participating in the community maintenance program for the intervention group was $374.77 (SD 142.12) and membership renewal was highest at community centres offering twice weekly, supervised exercise classes.
CONCLUSIONS
A post rehabilitation, community-based exercise program, will maintain exercise capacity in people with COPD who attend at least 50% of available sessions over one year. An increased focus on factors that determine adherence would help inform improvements in maintenance program design.",2020,"Restricting the analysis to those who attended ≥50% of the exercise sessions showed a significant intervention effect for 6MWD (β = 69.19, 95% CI = 10.16 to 128.22, p = 0.03).","['people with chronic obstructive pulmonary disease (COPD', 'Patients with COPD who completed PR', 'Ninety-seven patients (69\xa0±\xa09 years) were enrolled', 'people with COPD who attend at least 50% of available sessions over one year']","['community-based exercise program', 'post-rehabilitation, community-based maintenance program', 'community-based, post-rehabilitation exercise', 'pulmonary rehabilitation (PR', 'community-based maintenance program (intervention) or usual care (control']","['self-reported functional capacity, health-related quality of life, self-efficacy, program cost, and lower extremity muscle strength', '6-min walk distance (6MWD', 'exercise tolerance, functional capacity and quality of life', '6MWD over time (β\xa0']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.104461,"Restricting the analysis to those who attended ≥50% of the exercise sessions showed a significant intervention effect for 6MWD (β = 69.19, 95% CI = 10.16 to 128.22, p = 0.03).","[{'ForeName': 'Stacey J', 'Initials': 'SJ', 'LastName': 'Butler', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: stacey.butler@utoronto.ca.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Desveaux', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Annemarie L', 'Initials': 'AL', 'LastName': 'Lee', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Physiotherapy, Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Marla K', 'Initials': 'MK', 'LastName': 'Beauchamp', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Brusco', 'Affiliation': 'Rehabilitation, Ageing and Independent Living (RAIL) Research Centre, Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Cabrini Health, Malvern, Victoria, Australia; School of Public Health and Preventive Medicine, Monash University, Australia.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'Goldstein', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': 'Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada; Department of Physical Therapy, University of Toronto, Toronto, Ontario, Canada; School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106195']
1489,33171419,"A multi-centre, randomized, non-inferiority trial to compare ulipristal with standard surgical treatment in women with symptomatic uterine fibroids: Protocol of the MYOMEX-2 trial.","OBJECTIVES
Fibroids are the most common benign tumours found in the uterus and can cause various symptoms. In 20-50 % of the women, an intervention is required. When conservative options fail, invasive options such as hysterectomy, uterine artery embolization or myomectomy are eligible options. Ulipristal acetate (UPA) was launched as the sole available long term pharmaceutical treatment, with the potential to avoid surgery. It is suggested that UPA improves quality of life, reduces symptoms and fibroid volumes. However, UPA is an expensive medicine, is possibly associated with liver injury and has never been directly compared to surgical treatment. The aim of this trial is to compare UPA to surgical treatment on both effectiveness and cost-effectiveness. Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline. Secondary outcomes include quality of life, societal costs, societal participation, liver function variation, patient satisfaction and preference. Outcomes will be analysed according to intention-to-treat principle.
STUDY DESIGN
The MYOMEX-2 trial is an open-label, multicentre, non-inferiority randomized controlled trial. Patients are pre-menopausal women with symptomatic fibroids eligible for surgical treatment (hysterectomy, myomectomy or UAE). Fibroid symptoms may comprise (but are not limited to) heavy menstrual bleeding, bulk symptoms or pain. Patients are randomised 2:1 in a parallel group design between two treatment arms: 119 patients in the UPA group and 60 patients in the surgery group. Follow up comprises of online questionnaires, outpatient visits and phone appointments on several follow up moments, up to 24 months after surgery or start UPA.
REGISTRATION DETAILS
MYOMEX-2 trial; protocol version 4, date 22-02-2019; NTR6860; NL62638.029.18. All items from the World Health Organization Trial Registration Data Set are provided in the online supplementary file (Appendix-B).",2020,Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline.,"['Patients are pre-menopausal women with symptomatic fibroids eligible for surgical treatment (hysterectomy, myomectomy or UAE', 'women with symptomatic uterine fibroids', '119 patients in the UPA group and 60 patients in the surgery group']","['UPA', 'Ulipristal acetate (UPA', 'ulipristal with standard surgical treatment']","['quality of life, reduces symptoms and fibroid volumes', 'effectiveness and cost-effectiveness', 'reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire', 'quality of life, societal costs, societal participation, liver function variation, patient satisfaction and preference']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0300205', 'cui_str': 'ulipristal'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}]",,0.274217,Primary outcome is the reduction in symptom severity scores (part of the Uterine Fibroid Symptom and Quality of Life questionnaire) at 24 months of follow-up compared to baseline.,"[{'ForeName': 'Mei-An', 'Initials': 'MA', 'LastName': 'Middelkoop', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands; Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands. Electronic address: m.middelkoop@vumc.nl.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands; Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Marijke C Jansen', 'Initials': 'MCJ', 'LastName': 'van der Weide', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter J K', 'Initials': 'WJK', 'LastName': 'Hehenkamp', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands; Amsterdam University Medical Center, Department of Obstetrics and Gynaecology, Amsterdam Reproduction and Development, Meibergdreef 9, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.10.058']
1490,33171830,Acute Physiological Responses to High-Intensity Resistance Circuit Training vs. Traditional Strength Training in Soccer Players.,"The aim of this study was to evaluate and compare the cardiorespiratory and metabolic responses induced by high-intensity resistance circuit-based (HRC) and traditional strength (TS) training protocols. Ten amateur soccer players reported to the laboratory on four occasions: (1) protocol familiarization and load determination; (2) maximal oxygen consumption test; (3) and (4) resistance training protocols (HRC and TS), completed in a cross-over randomized order. In both protocols, the same structure was used (two blocks of 3 sets × 3 exercises, separated by a 5-min rest), with only the time between consecutive exercises differing: TS (3 min) and HRC (~35 s, allowing 3 min of local recovery). To test for between-protocol differences, paired t-tests were applied. Results showed that oxygen consumption and heart rate during HRC were 75% and 39% higher than TS, respectively ( p < 0.001). After the training sessions, blood lactate concentration at 1.5, 5 and 7 min and excess post-exercise oxygen consumption were higher in HRC. The respiratory exchange ratio was 6.7% greater during HRC, with no between-group differences found post-exercise. The energy cost of HRC was ~66% higher than TS. In conclusion, HRC training induces greater cardiorespiratory and metabolic responses in soccer players and thus may be a time-effective training strategy.",2020,"The respiratory exchange ratio was 6.7% greater during HRC, with no between-group differences found post-exercise.","['soccer players', 'Soccer Players', 'Ten amateur soccer players']","['high-intensity resistance circuit-based (HRC) and traditional strength (TS) training protocols', 'HRC training', 'HRC ', 'High-Intensity Resistance Circuit Training vs. Traditional Strength Training', 'protocol familiarization and load determination; (2) maximal oxygen consumption test; (3) and (4) resistance training protocols (HRC and TS']","['energy cost of HRC', 'oxygen consumption and heart rate during HRC', 'respiratory exchange ratio', 'blood lactate concentration', 'cardiorespiratory and metabolic responses']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2712423', 'cui_str': 'Circuit Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0216635,"The respiratory exchange ratio was 6.7% greater during HRC, with no between-group differences found post-exercise.","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Marín-Pagán', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, 30.107 Murcia, Spain.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Blazevich', 'Affiliation': 'Centre for Exercise and Sports Science Research, School of Medical and Health Sciences, Edith Cowan University, 6027 Joondalup, Australia.'}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Chung', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, 30.107 Murcia, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Romero-Arenas', 'Affiliation': 'Faculty of Sport Science, Catholic University of Murcia, 30.107 Murcia, Spain.'}, {'ForeName': 'Tomás T', 'Initials': 'TT', 'LastName': 'Freitas', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, 30.107 Murcia, Spain.'}, {'ForeName': 'Pedro E', 'Initials': 'PE', 'LastName': 'Alcaraz', 'Affiliation': 'Research Center for High Performance Sport, Catholic University of Murcia, 30.107 Murcia, Spain.'}]",Biology,['10.3390/biology9110383']
1491,33176071,Happiness During Low-Dose Ketamine Infusion Predicts Treatment Response: Reexploring the Adjunctive Ketamine Study of Taiwanese Patients With Treatment-Resistant Depression.,"BACKGROUND
Studies have reported that ketamine potentially increases subjective happiness in healthy volunteers. However, whether ketamine-induced happiness can predict the treatment response of ketamine infusion among patients with treatment-resistant depression (TRD) remains unknown.
METHODS
Between 2012 and 2015, 71 adult patients with TRD (based on DSM-IV-TR criteria) were enrolled and randomly assigned to receive a 40-minute ketamine (0.5 mg/kg or 0.2 mg/kg) or normal saline placebo infusion. Depressive symptoms were measured using the 17-item Hamilton Depression Rating Scale. Measurements were conducted prior to infusion, at 40 and 240 minutes postinfusion, and, sequentially, on days 2 to 7 and 14 postinfusion. The visual analog scale for happiness (VASH) was used to assess happiness during infusion. The positive symptoms subscale of the Brief Psychiatric Rating Scale (BPRS-P) was used to measure the potential psychotomimetic effects of ketamine.
RESULTS
For both the 2-factor (ketamine vs placebo) and 3-factor (ketamine 0.5 mg/kg vs 0.2 mg/kg vs placebo) models, a generalized estimating equation model indicated that infusion response type (happiness vs nonhappiness) significantly (P = .008 vs P = .002) predicted the trajectory of depressive symptoms after infusion. Changes in VASH and BPRS-P measures were not associated with each other.
CONCLUSIONS
Subjective happiness during ketamine infusion predicted the antidepressant effect of both 0.5 mg/kg and 0.2 mg/kg ketamine infusion over time. Happiness during ketamine infusion, which was not related to the psychotomimetic effect of ketamine, may be associated with the reduction of depressive symptoms during the follow-up.
TRIAL REGISTRATION
UMIN Clinical Trials Registry registration number: UMIN000016985.",2020,"Changes in VASH and BPRS-P measures were not associated with each other.
","['patients with treatment-resistant depression (TRD', 'healthy volunteers', 'Infusion Predicts Treatment Response', 'Taiwanese Patients With Treatment-Resistant Depression', 'Between 2012 and 2015, 71 adult patients with TRD (based on DSM-IV-TR criteria']","['2-factor (ketamine vs placebo) and 3-factor (ketamine', 'Ketamine', 'ketamine', 'normal saline placebo infusion', '40-minute ketamine']","['positive symptoms subscale of the Brief Psychiatric Rating Scale (BPRS-P', '17-item Hamilton Depression Rating Scale', 'VASH and BPRS-P measures', 'trajectory of depressive symptoms', 'depressive symptoms', 'subjective happiness', 'Depressive symptoms', 'visual analog scale for happiness (VASH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",71.0,0.129063,"Changes in VASH and BPRS-P measures were not associated with each other.
","[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, Taipei Veterans General Hospital, No. 201, Sec 2, Shih-Pai Rd, Beitou District, Taipei, 112, Taiwan. tomsu0402@gmail.com.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13232']
1492,33179323,Reversion From Chronic Migraine to Episodic Migraine in Patients Treated With Fremanezumab: Post Hoc Analysis From HALO CM Study.,"BACKGROUND
Migraine preventive medications are used to reduce headache frequency, severity, and duration. In patients with chronic migraine (CM), reversion to episodic migraine (EM) is an important treatment goal.
OBJECTIVE
To evaluate the effect of fremanezumab on the rate of reversion from CM to EM.
METHODS
This phase 3, randomized, double-blind, placebo-controlled, parallel-group trial included a 28-day pretreatment period and a 3-month treatment period. Patients with CM received subcutaneous fremanezumab quarterly (675 mg at baseline) or monthly (675 mg at baseline; 225 mg at Weeks 4 and 8), or placebo. Post hoc analyses evaluated the proportion of patients who reverted from CM to EM, defined as either a reduction to an average of <15 headache days per month during the 3-month treatment period or a reduction to <15 headache days per month in all 3 months of the treatment period.
RESULTS
This analysis included data from 1088 CM patients (quarterly, n = 366; monthly, n = 365; placebo, n = 357). More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]). Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM.
CONCLUSIONS
Fremanezumab may offer the benefit of reversion from CM to EM, based on a reduction in the number of headache days over 3 months of treatment.",2020,"More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]).","['patients with chronic migraine (CM), reversion to episodic migraine (EM', '1088 CM patients (quarterly, n\xa0=\xa0366; monthly, n\xa0=\xa0365; placebo, n\xa0=\xa0357', 'Patients with CM who reported previous topiramate or onabotulinumtoxinA use, concomitant preventive medication use, or medication overuse were less likely to revert to EM', 'Patients']","['Fremanezumab', 'placebo', 'fremanezumab', 'subcutaneous fremanezumab']",['monthly headache day count'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3266697', 'cui_str': 'Medication overuse'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",,0.19887,"More fremanezumab-treated patients with CM reverted to EM using either the monthly average number of headache days criteria for reversion (quarterly: 50.5% [185/366], P = .108; monthly: 53.7% [196/365], P = .012; vs placebo: 44.5% [159/357]) or the monthly headache day count at Months 1, 2, and 3 criteria for reversion (quarterly: 31.2% [114/366], P = .008; monthly: 33.7% [123/365], P = .001; vs placebo: 22.4% [80/357]).","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Bibeau', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Galic', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Amsterdam, The Netherlands.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Ramirez Campos', 'Affiliation': 'Teva Pharmaceutical Industries Ltd., Frazer, PA, USA.'}, {'ForeName': 'Rashmi B', 'Initials': 'RB', 'LastName': 'Halker Singh', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'MedStar Georgetown University Hospital, Washington, DC, USA.'}]",Headache,['10.1111/head.13997']
1493,33179388,Effects of different splinting times on surgically extruded teeth with a crown-root fracture: A randomized controlled trial.,"BACKGROUND/AIM
Clinical studies evaluating the splinting time for surgically extruded teeth with crown-root fractures are lacking. The aim of this study was to compare 2-week splinting versus functional splinting times after surgical extrusion.
MATERIAL AND METHODS
Children aged 8-13 years who presented with crown-root fractures were included. Surgical extrusion was performed, and teeth were splinted either for 2 weeks or until normal Periotest values were achieved (functional splinting time). The outcome measures were tooth mobility, tooth loss, root resorption, marginal bone resorption and ankylosis. Measurements were taken at baseline, weekly after splint removal, and after 1, 3, 6 and 12 months.
RESULTS
Nineteen patients were included in the analysis. Surgically extruded teeth splinted for 2 weeks showed significantly higher mobility directly after splint removal and at 1 month after splinting compared with the functional splinting time group. The mean differences for horizontal Periotest values were 14.96 (95% confidence interval: 8.52, 21.39) and 6.63 (95% confidence interval: 0.25, 13), respectively. The vertical Periotest values were 10.47 (95% confidence interval: 1.95, 18.99) and 4.81 (95% confidence interval: -1.57, 11.18), respectively. At the 3-, 6- and 12-month follow-up intervals, there were no statistically significant differences between the groups. One tooth in the 2-week splinting group was lost. None of the teeth had ankylosis, marginal bone resorption or root resorption.
CONCLUSIONS
Although both groups showed neither statistical nor clinically significant differences after 12 months, there was a significant difference immediately after splint removal, with greater tooth mobility in the 2-week splinting group. Thus, a functional splinting time (4-6 weeks) can be suggested for better healing and optimal stability to allow placement of the final restoration directly after splint removal.",2020,Surgically extruded teeth splinted for 2 weeks showed significantly higher mobility directly after splint removal and at 1 month after splinting compared with the functional splinting time group.,"['Nineteen patients were included in the analysis', 'surgically extruded teeth with a crown-root fracture', 'Children aged 8-13 years who presented with crown-root fractures were included']",[],"['ankylosis, marginal bone resorption, or root resorption', 'vertical Periotest values', 'tooth mobility, tooth loss, root resorption, marginal bone resorption, and ankylosis', 'tooth mobility', 'horizontal Periotest values']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0532245', 'cui_str': 'Extrude'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}]",[],"[{'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0035851', 'cui_str': 'Root Resorption'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040445', 'cui_str': 'Tooth mobility'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",19.0,0.0564202,Surgically extruded teeth splinted for 2 weeks showed significantly higher mobility directly after splint removal and at 1 month after splinting compared with the functional splinting time group.,"[{'ForeName': 'Maii', 'Initials': 'M', 'LastName': 'Mohamed', 'Affiliation': 'Pediatric Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Moheb', 'Affiliation': 'Pediatric Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nevine', 'Initials': 'N', 'LastName': 'Waly', 'Affiliation': 'Pediatric Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abdalsamad', 'Affiliation': 'Department of Oral Radiology, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elkhadem', 'Affiliation': 'Pediatric Dentistry Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.'}]",Dental traumatology : official publication of International Association for Dental Traumatology,['10.1111/edt.12624']
1494,33181655,"The effect of comprehensive assessment and multi-disciplinary management for the geriatric and frail patient: A multi-center, randomized, parallel controlled trial.","BACKGROUND
A comprehensive geriatric assessment (CGA) of elderly patients is useful for detecting the patients vulnerabilities. Exercise and early rehabilitation, nutritional intervention, traditional Chinese medicine (TCM), standardized medication guidance, and patient education can, separately, improve and even reverse the physical frailty status. However, the effect of combining a CGA and multi-disciplinary management on frailty in elderly patients remains unclear. The present study assessed the effects of a CGA and multi-disciplinary management on elderly patients with frailty in China.
METHODS
In this study, 320 in patients with frailty ≥70 years old will be randomly divided into an intervention group and a control group. The intervention group will be given routine management, a CGA and multi-disciplinary management involving rehabilitation exercise, diet adjustment, multi-drug evaluation, acupoint massage in TCM and patient education for 12 months, and the control group will be followed up with routine management for basic diseases. The primary outcomes are the Fried phenotype and short physical performance battery (SPPB). The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL), 5-level European quality of life 5 dimensions index (EQ-5D), nutrition risk screening-2002 (NRS-2002), medical insurance expenses, fall events, and all-cause mortality. In addition, a cost-effectiveness study will be carried out.
DISCUSSION
This paper outlines the protocol for a randomized, single-blind, parallel multi-center clinical study. This protocol, if beneficial, will demonstrate the interaction of various intervention strategies, will help improve elderly frailty patients, and will be useful for clinicians, nurses, policymakers, public health authorities, and the general population.
TRIAL REGISTRATION
Chinese Clinical Trials Register, ChiCTR1900022623. Registered on April 19, 2019, http://www.chictr.org.cn/showproj.aspx?proj=38141.",2020,"The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL),","['geriatric and frail patient', 'elderly patients', '320 in patients with frailty ≥70 years old', 'elderly patients with frailty in China', 'elderly frailty patients']","['routine management, a CGA and multi-disciplinary management involving rehabilitation exercise, diet adjustment, multi-drug evaluation, acupoint massage in TCM and patient education for 12 months, and the control group will be followed up with routine management for basic diseases', 'comprehensive assessment and multi-disciplinary management', 'CGA and multi-disciplinary management', 'Exercise and early rehabilitation, nutritional intervention, traditional Chinese medicine (TCM), standardized medication guidance, and patient education']","['Fried phenotype and short physical performance battery (SPPB', 'clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL', '5-level European quality of life 5 dimensions index (EQ-5D), nutrition risk screening-2002 (NRS-2002), medical insurance expenses, fall events, and all-cause mortality']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017463', 'cui_str': 'Geriatric screening'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C1510451', 'cui_str': 'French fries'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C1290927', 'cui_str': 'Basic activity of daily living'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",320.0,0.0516481,"The secondary outcomes are the clinical frailty scale (CFS), non-elective hospital readmission, basic activities of daily living (BADL),","[{'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Pharmacy.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nutriology.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of TCM, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, PR China.'}, {'ForeName': 'Yuhao', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Jiefu', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Hospital, National Center of Gerontology.'}]",Medicine,['10.1097/MD.0000000000022873']
1495,33185468,"A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder.","Objectives: In a previous pivotal study of children and adolescents (aged 6-17 years) with attention-deficit/hyperactivity disorder (ADHD), dose-optimized SHP465 mixed amphetamine salts (MAS) extended-release (12.5-25 mg once daily) was superior to placebo in reducing ADHD symptoms. This study evaluated the efficacy, tolerability, and safety of 6.25 mg SHP465 MAS once daily (one-half the lowest approved dose for adolescents and adults) versus placebo in children aged 6-12 years with ADHD. Methods: Children (aged 6-12 years) with Diagnostic and Statistical Manual of Mental Disorders, Fifth edition-defined ADHD; baseline ADHD-Rating Scale, Fifth Edition, Child, Home Version total scores (ADHD-RS-5-HV-TS) ≥28; and baseline Clinical Global Impressions-Severity scores ≥4 were eligible. Participants received 6.25 mg SHP465 MAS once daily or placebo for 4 weeks. The primary (ADHD-RS-5-HV-TS change from baseline at week 4) and key secondary (Clinical Global Impressions-Improvement [CGI-I] score at week 4) efficacy end points were assessed using linear mixed-effects models for repeated measures. Safety and tolerability assessments included treatment-emergent adverse events (TEAEs) and vital sign changes. Results: Of 89 randomized participants, 83 completed the study (placebo, n = 41; SHP465 MAS, n = 42). At week 4, the least squares mean (95% confidence interval) treatment differences (SHP465 MAS-placebo) were not statistically significant for ADHD-RS-5-HV-TS change (-1.9 [-6.8 to 3.1], p = 0.451; effect size [ES] = 0.17) or CGI-I score (-0.1 [-0.5 to 0.3], nominal p = 0.597; ES = 0.12). The percentage of participants reporting TEAEs was 16.3% with placebo and 24.4% with SHP465 MAS. The most frequently reported TEAEs (placebo; SHP465 MAS) were headache (7.0%; 4.4%) and decreased appetite (4.7%; 2.2%). Minimal increases in blood pressure were observed with SHP465 MAS at the final on-treatment assessment. Conclusions: SHP465 MAS 6.25 mg once daily (one-half the lowest dose approved for adolescents and adults) was well tolerated in children aged 6-12 years but was not superior to placebo in reducing ADHD symptoms, suggesting that this dose of SHP465 MAS was subtherapeutic in this age group. The Clinical Trial Registration number: NCT03325881.",2020,Minimal increases in blood pressure were observed with SHP465 MAS at the final on-treatment assessment. ,"['adolescents and adults', '89 randomized participants, 83 completed the study (placebo, n \u2009=\u200941; SHP465 MAS, n \u2009=\u200942', 'children aged 6-12 years with ADHD', 'Methods: Children (aged 6-12 years) with Diagnostic and Statistical Manual of Mental Disorders, Fifth edition-defined ADHD; baseline ADHD-Rating Scale, Fifth Edition, Child, Home Version total scores (ADHD-RS-5-HV-TS) ≥28; and baseline Clinical Global Impressions-Severity scores ≥4 were eligible', 'children and adolescents (aged 6-17 years) with attention-deficit/hyperactivity disorder (ADHD), dose-optimized', 'Children with Attention-Deficit/Hyperactivity Disorder']","['SHP465 MAS', 'SHP465 MAS once daily or placebo', 'SHP465 mixed amphetamine salts (MAS', 'placebo', 'Low-Dose SHP465 Mixed Amphetamine Salts']","['headache', 'blood pressure', 'ADHD-RS-5-HV-TS change', 'efficacy, tolerability, and safety', 'appetite', 'Safety and tolerability assessments included treatment-emergent adverse events (TEAEs) and vital sign changes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",89.0,0.43614,Minimal increases in blood pressure were observed with SHP465 MAS at the final on-treatment assessment. ,"[{'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Mattingly', 'Affiliation': 'Midwest Research Group, St. Charles, Missouri, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Arnold', 'Affiliation': 'CNS Healthcare, Memphis, Tennessee, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Biostatistics, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Global Clinical Development, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Robertson', 'Affiliation': 'Global Clinical Development, Shire, a Member of the Takeda Group of Companies, Lexington, Massachusetts, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0005']
1496,33185560,Once Daily Versus Overnight and Symptom Versus Physiological Monitoring to Detect Exacerbations of Chronic Obstructive Pulmonary Disease: Pilot Randomized Controlled Trial.,"BACKGROUND
Earlier detection of chronic obstructive pulmonary disease (COPD) exacerbations may facilitate more rapid treatment with reduced risk of hospitalization. Changes in pulse oximetry may permit early detection of exacerbations. We hypothesized that overnight pulse oximetry would be superior to once-daily monitoring for the early detection of exacerbations.
OBJECTIVE
This study aims to evaluate whether measuring changes in heart rate and oxygen saturation overnight is superior to once-daily monitoring of both parameters and to assess symptom changes in facilitating earlier detection of COPD exacerbations.
METHODS
A total of 83 patients with COPD were randomized to once-daily or overnight pulse oximetry. Both groups completed the COPD assessment test questionnaire daily. The baseline mean and SD for each pulse oximetry variable were calculated from 14 days of stable monitoring. Changes in exacerbation were expressed as Z scores from this baseline.
RESULTS
The mean age of the patients was 70.6 (SD 8.1) years, 52% (43/83) were female, and the mean FEV1 was 53.0% (SD 18.5%) predicted. Of the 83 patients, 27 experienced an exacerbation. Symptoms were significantly elevated above baseline from 5 days before to 12 days after treatment initiation. Day-to-day variation in pulse oximetry during the stable state was significantly less in the overnight group than in the once-daily group. There were greater relative changes at exacerbation in heart rate than oxygen saturation. An overnight composite score of change in heart rate and oxygen saturation changed significantly from 7 days before initiation of treatment for exacerbation and had a positive predictive value for exacerbation of 91.2%. However, this was not statistically better than examining changes in symptoms alone.
CONCLUSIONS
Overnight pulse oximetry permits earlier detection of COPD exacerbations compared with once-daily monitoring. Monitoring physiological variables was not superior to monitoring symptoms, and the latter would be a simpler approach, except where there is a need for objective verification of exacerbations.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03003702; https://clinicaltrials.gov/ct2/show/NCT03003702.",2020,An overnight composite score of change in heart rate and oxygen saturation changed significantly from 7 days before initiation of treatment for exacerbation and had a positive predictive value for exacerbation of 91.2%.,"['83 patients with COPD', 'Chronic Obstructive Pulmonary Disease', '83 patients, 27 experienced an exacerbation', 'chronic obstructive pulmonary disease (COPD) exacerbations']","['Once Daily Versus Overnight and Symptom Versus Physiological Monitoring', 'Overnight pulse oximetry', 'overnight pulse oximetry']","['mean FEV1', 'COPD exacerbations', 'heart rate and oxygen saturation', 'COPD assessment test questionnaire daily', 'pulse oximetry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026429', 'cui_str': 'Physiologic Monitoring'}, {'cui': 'C0430630', 'cui_str': 'Overnight pulse oximetry'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}]",83.0,0.690075,An overnight composite score of change in heart rate and oxygen saturation changed significantly from 7 days before initiation of treatment for exacerbation and had a positive predictive value for exacerbation of 91.2%.,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Al Rajeh', 'Affiliation': 'Department of respiratory care, King Faisal University, Al-Ahsa, Saudi Arabia.'}, {'ForeName': 'Yousef Saad', 'Initials': 'YS', 'LastName': 'Aldabayan', 'Affiliation': 'Department of respiratory care, King Faisal University, Al-Ahsa, Saudi Arabia.'}, {'ForeName': 'Abdulelah', 'Initials': 'A', 'LastName': 'Aldhahir', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Pickett', 'Affiliation': 'Department of respiratory medicine, Royal Free London NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Shumonta', 'Initials': 'S', 'LastName': 'Quaderi', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Jaber S', 'Initials': 'JS', 'LastName': 'Alqahtani', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Mandal', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Marc Ci', 'Initials': 'MC', 'LastName': 'Lipman', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hurst', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}]",JMIR mHealth and uHealth,['10.2196/17597']
1497,33181081,"Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial.","BACKGROUND
Febuxostat and allopurinol are urate-lowering therapies used to treat patients with gout. Following concerns about the cardiovascular safety of febuxostat, the European Medicines Agency recommended a post-licensing study assessing the cardiovascular safety of febuxostat compared with allopurinol.
METHODS
We did a prospective, randomised, open-label, blinded-endpoint, non-inferiority trial of febuxostat versus allopurinol in patients with gout in the UK, Denmark, and Sweden. Eligible patients were 60 years or older, already receiving allopurinol, and had at least one additional cardiovascular risk factor. Those who had myocardial infarction or stroke in the previous 6 months or who had severe congestive heart failure or severe renal impairment were excluded. After a lead-in phase in which allopurinol dose was optimised towards achieving a serum urate concentration of less than 0·357 mmol/L (<6 mg/dL), patients were randomly assigned (1:1, with stratification according to previous cardiovascular events) to continue allopurinol (at the optimised dose) or start febuxostat at 80 mg/day, increasing to 120 mg/day if necessary to achieve the target serum urate concentration. The primary outcome was a composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death. The hazard ratio (HR) for febuxostat versus allopurinol in a Cox proportional hazards model (adjusted for the stratification variable and country) was assessed for non-inferiority (HR limit 1·3) in an on-treatment analysis. This study is registered with the EU Clinical Trials Register (EudraCT 2011-001883-23) and ISRCTN (ISRCTN72443728) and is now closed.
FINDINGS
From Dec 20, 2011, to Jan 26, 2018, 6128 patients (mean age 71·0 years [SD 6·4], 5225 [85·3%] men, 903 [14·7%] women, 2046 [33·4%] with previous cardiovascular disease) were enrolled and randomly allocated to receive allopurinol (n=3065) or febuxostat (n=3063). By the study end date (Dec 31, 2019), 189 (6·2%) patients in the febuxostat group and 169 (5·5%) in the allopurinol group withdrew from all follow-up. Median follow-up time was 1467 days (IQR 1029-2052) and median on-treatment follow-up was 1324 days (IQR 870-1919). For incidence of the primary endpoint, on-treatment, febuxostat (172 patients [1·72 events per 100 patient-years]) was non-inferior to allopurinol (241 patients [2·05 events per 100 patient-years]; adjusted HR 0·85 [95% CI 0·70-1·03], p<0·0001). In the febuxostat group, 222 (7·2%) of 3063 patients died and 1720 (57·3%) of 3001 in the safety analysis set had at least one serious adverse event (with 23 events in 19 [0·6%] patients related to treatment). In the allopurinol group, 263 (8·6%) of 3065 patients died and 1812 (59·4%) of 3050 had one or more serious adverse events (with five events in five [0·2%] patients related to treatment). Randomised therapy was discontinued in 973 (32·4%) patients in the febuxostat group and 503 (16·5%) patients in the allopurinol group.
INTERPRETATION
Febuxostat is non-inferior to allopurinol therapy with respect to the primary cardiovascular endpoint, and its long-term use is not associated with an increased risk of death or serious adverse events compared with allopurinol.
FUNDING
Menarini, Ipsen, and Teijin Pharma Ltd.",2020,The primary outcome was a composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death.,"['973 (32·4%) patients in the febuxostat group and 503 (16·5%) patients in the allopurinol group', 'Eligible patients were 60 years or older, already receiving allopurinol, and had at least one additional cardiovascular risk factor', 'Those who had myocardial infarction or stroke in the previous 6 months or who had severe congestive heart failure or severe renal impairment were excluded', '241 patients [2·05 events per 100 patient-years]; adjusted HR 0·85', 'patients with gout', 'patients with gout (FAST', 'patients with gout in the UK, Denmark, and Sweden', 'From Dec 20, 2011, to Jan 26, 2018, 6128 patients (mean age 71·0 years [SD 6·4], 5225 [85·3%] men, 903 [14·7%] women, 2046 [33·4%] with previous cardiovascular disease']","['start febuxostat', 'allopurinol (n=3065) or febuxostat', 'febuxostat versus allopurinol', 'febuxostat', 'allopurinol', 'Febuxostat and allopurinol']","['cardiovascular safety', 'composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death', 'hazard ratio (HR', 'serious adverse event', 'serum urate concentration', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",6128.0,0.255384,The primary outcome was a composite of hospitalisation for non-fatal myocardial infarction or biomarker-positive acute coronary syndrome; non-fatal stroke; or cardiovascular death.,"[{'ForeName': 'Isla S', 'Initials': 'IS', 'LastName': 'Mackenzie', 'Affiliation': 'MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'The Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nuki', 'Affiliation': 'Centre for Genomic and Experimental Medicine, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Hallas', 'Affiliation': 'University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hawkey', 'Affiliation': 'Nottingham Digestive Diseases Centre, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': 'Clinical Pharmacology Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Stuart H', 'Initials': 'SH', 'LastName': 'Ralston', 'Affiliation': 'Molecular Medicine Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Walters', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Robertson', 'Affiliation': 'The Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': ""University of Pisa, Pisa University Hospital, and Fondazione VillaSerena per la Ricerca, CittàSant'Angelo, Pescara, Italy.""}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Findlay', 'Affiliation': 'MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Perez-Ruiz', 'Affiliation': 'Osakidetza, OSI EE-Cruces, Cruces University Hospital-Rheumatology Division, Biskay, Spain.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'MacDonald', 'Affiliation': 'MEMO Research, Division of Molecular and Clinical Medicine, University of Dundee, Dundee, UK. Electronic address: t.m.macdonald@dundee.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32234-0']
1498,33181169,Transcutaneous application of the gaseous CO 2 for improvement of the microvascular function in patients with diabetic foot ulcers.,"INTRODUCTION
Microvascular function is impaired in patients with diabetes mellitus (DM) and is involved in numerous DM complications. Several microvascular-supporting interventions have been proposed of which the transcutaneous application of gaseous CO 2 (hereinafter CO 2 therapy) is one of the most promising. The aim of present study was to determine the effect of repeated CO 2 therapies on the cutaneous microvascular function in DM patients with diabetic foot ulcers.
METHODOLOGY
A total of 42 subjects with at least one chronic diabetic foot ulcer were enrolled in the study. They were divided into the experimental group (21 subjects aged 64.6 ± 11.6 years) that underwent 4-week-long treatment with transcutaneous application of gaseous CO 2 (hereinafter CO 2 therapies), and the placebo group (21 subjects aged 65.0 ± 10.7 years) that underwent 4-week-long placebo treatment with transcutaneous application of air. Before the first and after the last treatment in both groups, laser Doppler (LD) flux in foot cutaneous microcirculation, heart rate, and arterial blood pressure measurements were carried out during rest and local thermal hyperaemia (LTH) provocation test.
RESULTS
In the experimental group the following statistically significant changes were observed after the completed treatment 1) increased mean relative powers of LD flux signals during rest in the frequency bands related to NO-independent endothelial (0.07 ± 0.055 vs. 0.048 ± 0.059, p = 0.0058), NO-mediated endothelial (0.154 ± 0.101 vs. 0.113 ± 0.108, p = 0.015), and neurogenic (0.17 ± 0.107 vs. 0.136 ± 0.098, p = 0.018) activity; 2) decreased resting LD flux (35 ± 29 PU vs. 52 ± 56 PU; p = 0.038); and 3) increased peak LD flux as a function of baseline during LTH (482 ± 474%BL vs. 287 ± 262%BL, p = 0.036); there were no statistically significant changes observed in the placebo group. No systemic effects were observed in none of the two groups by means of mean values of heart rate and arterial blood pressure.
CONCLUSIONS
Repeated CO 2 therapies improves the microvasular function in DM patients without any systemic side effects.",2021,"No systemic effects were observed in none of the two groups by means of mean values of heart rate and arterial blood pressure.
","['group (21 subjects aged 65.0±10.7\u202fyears) that underwent', 'patients with diabetes mellitus (DM', 'patients with diabetic foot ulcers', 'DM patients with diabetic foot ulcers', '42 subjects with at least one chronic diabetic foot ulcer', '21 subjects aged 64.6±11.6\u202fyears) that underwent']","['4-week-long treatment with transcutaneous application of gaseous CO 2 (hereinafter CO 2 therapies), and the placebo', 'placebo', 'CO 2 therapies', '4-week-long placebo treatment with transcutaneous application of air']","['laser Doppler (LD) flux in foot cutaneous microcirculation, heart rate, and arterial blood pressure measurements', 'systemic effects', 'neurogenic', 'mean relative powers of LD flux signals', 'NO-mediated endothelial', 'mean values of heart rate and arterial blood pressure', 'cutaneous microvascular function', 'resting LD flux', 'peak LD flux', 'microvasular function', 'microvascular function']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0430489', 'cui_str': 'Laser doppler'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",42.0,0.0947368,"No systemic effects were observed in none of the two groups by means of mean values of heart rate and arterial blood pressure.
","[{'ForeName': 'Miha', 'Initials': 'M', 'LastName': 'Finžgar', 'Affiliation': 'Faculty of Mechanical Engineering, University of Ljubljana, Aškerčeva c. 6, Ljubljana, Slovenia.'}, {'ForeName': 'Helena Ban', 'Initials': 'HB', 'LastName': 'Frangež', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Ljubljana, Šlajmerjeva ul. 3, 1000 Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Cankar', 'Affiliation': 'Institute of Physiology, Faculty of Medicine, University of Ljubljana, Zaloška c. 4, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Frangež', 'Affiliation': 'Faculty of Medicine, University of Ljubljana, Vrazov trg 2, 1000 Ljubljana, Slovenia; Department of Surgical Infections, University Medical Centre Ljubljana, Zaloška c. 2, 1000 Ljubljana, Slovenia. Electronic address: ifrangez@gmail.com.'}]",Microvascular research,['10.1016/j.mvr.2020.104100']
1499,33210302,COVIDOSE: A phase 2 clinical trial of low-dose tocilizumab in the treatment of non-critical COVID-19 pneumonia.,"Interleukin-6 (IL-6)-mediated hyperinflammation may contribute to the mortality of coronavirus disease 2019 (COVID-19). The IL-6 receptor blocking monoclonal antibody tocilizumab has been repurposed for COVID-19, but prospective trials and dose-finding studies in COVID-19 have not yet fully reported. We conducted a single-arm phase 2 trial of low-dose tocilizumab in non-intubated hospitalized adult patients with COVID-19, radiographic pulmonary infiltrate, fever, and C-reactive protein (CRP) ≥ 40 mg/L. We hypothesized that doses significantly lower than the emerging standards of 400 mg or 8 mg/kg would resolve clinical and laboratory indicators of hyperinflammation. A dose range from 40 to 200 mg was evaluated, with allowance for one repeat dose at 24 to 48 hours. The primary objective was to assess the relationship of dose to fever resolution and CRP response. Thirty-two patients received low-dose tocilizumab, with the majority experiencing fever resolution (75%) and CRP decline consistent with IL-6 pathway abrogation (86%) in the 24-48 hours following drug administration. There was no evidence of a relationship between dose and fever resolution or CRP decline over the dose range of 40-200 mg. Within the 28-day follow-up, 5 (16%) patients died. For patients who recovered, median time to clinical recovery was 3 days (IQR, 2-5). Clinically presumed and/or cultured bacterial superinfections were reported in 5 (16%) patients. Low-dose tocilizumab was associated with rapid improvement in clinical and laboratory measures of hyperinflammation in hospitalized patients with COVID-19. Results of this trial provide rationale for a randomized, controlled trial of low-dose tocilizumab in COVID-19.",2020,Low-dose tocilizumab was associated with rapid improvement in clinical and laboratory measures of hyperinflammation in hospitalized patients with COVID-19.,"['non-critical COVID-19 pneumonia', 'hospitalized patients with COVID-19', 'non-intubated hospitalized adult patients with COVID-19, radiographic pulmonary infiltrate, fever, and C-reactive protein (CRP) ≥ 40 mg/L']","['low-dose tocilizumab', 'tocilizumab']","['relationship of dose to fever resolution and CRP response', 'CRP decline consistent with IL-6 pathway abrogation', 'fever resolution or CRP decline', 'median time to clinical recovery']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.304254,Low-dose tocilizumab was associated with rapid improvement in clinical and laboratory measures of hyperinflammation in hospitalized patients with COVID-19.,"[{'ForeName': 'Garth W', 'Initials': 'GW', 'LastName': 'Strohbehn', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Heiss', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Sherin J', 'Initials': 'SJ', 'LastName': 'Rouhani', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Trujillo', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jovian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alec J', 'Initials': 'AJ', 'LastName': 'Kacew', 'Affiliation': 'Pritzker School of Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Higgs', 'Affiliation': 'Committee on Immunology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Bloodworth', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Cabanov', 'Affiliation': 'Committee on Immunology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Adriana K', 'Initials': 'AK', 'LastName': 'Koziol', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': 'Department of Medicine, Section of Pulmonary and Critical Care Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Danahey', 'Affiliation': 'Center for Personalized Therapeutics, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Karrison', 'Affiliation': 'Department of Public Health Policy, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Cuoghi C', 'Initials': 'CC', 'LastName': 'Edens', 'Affiliation': 'Department of Medicine, Section of Rheumatology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Iazsmin Bauer', 'Initials': 'IB', 'LastName': 'Ventura', 'Affiliation': 'Department of Medicine, Section of Rheumatology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Natasha N', 'Initials': 'NN', 'LastName': 'Pettit', 'Affiliation': 'Department of Pharmacy, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Bhakti K', 'Initials': 'BK', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Section of Pulmonary and Critical Care Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pisano', 'Affiliation': 'Department of Medicine, Section of Infectious Diseases and Global Health, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Strek', 'Affiliation': 'Department of Medicine, Section of Pulmonary and Critical Care Medicine, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': 'Department of Medicine, Section of Hematology/Oncology, The University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Pankti D', 'Initials': 'PD', 'LastName': 'Reid', 'Affiliation': 'Department of Medicine, Section of Rheumatology, The University of Chicago, Chicago, IL, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2117']
1500,33210806,Massage enhances recovery following exercise-induced muscle damage in older adults.,"To examine efficacy of cold water immersion (CWI) and massage as recovery techniques on joint position sense, balance, and fear of falling following exercise-induced muscle damage in older adults. Seventy-eight older men and women performed a single bout of strength training on the calf muscles (3 exercises with 4 sets of 10 reps with 75% of 1RM) to induce muscle damage. After the damaging exercise, participants received either a 15-minute massage on calf muscles, or a CWI of the lower limb in cold water (15 ± 1°C) for 15 minute, or passive rest. Interventions were applied immediately after the exercise protocol and at 24, 48, and 72 hours post-exercise. Muscle pain, calf muscle strength, joint position sense, dynamic balance, postural sway, and fear of falling were measured at each time point. Repeated application of massage after EIMD relieved muscle pain, attenuated the loss of muscle strength and joint position senses, reduce balance impairments, and fear of falling in older adults (P ≤ .05). However, repeated applications of CWI, despite relieving muscle pain (P ≤ .05), did not attenuate the loss of muscle strength, joint position senses, balance impairments, and fear of falling. CWI had only some modest effects on muscle pain, but massage attenuated EIMD symptoms and the related impairments in muscle strength, joint position sense, balance, and postural sway in untrained older individuals. Therefore, older exercisers who plan to participate in strength training can benefit from massage for recovery from muscle damage indices and balance to decrease falling risk during the days following strength training.",2020,"However, repeated applications of CWI, despite relieving muscle pain (p≤0.05), did not attenuate the loss of muscle strength, joint position senses, balance impairments, and fear of falling.","['older adults', 'Seventy-eight older men and women performed a', 'older exercisers who plan to participate in', 'untrained older individuals']","['15-min massage on calf muscles, or a CWI of the lower limb in cold water (15±1°C) for 15 min, or passive rest', 'Massage', 'cold-water immersion (CWI) and massage', 'strength training', 'single bout of strength training on the calf muscles (3 exercises with 4 sets of 10 reps with 75% of 1RM']","['loss of muscle strength and joint position senses', 'Muscle pain, calf muscle strength, joint position sense, dynamic balance, postural sway and fear of falling', 'joint position sense, balance, and fear of falling', 'loss of muscle strength, joint position senses, balance impairments, and fear of falling', 'muscle pain', 'muscle strength, joint position sense, balance, and postural sway', 'balance impairments and fear of falling']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0180776', 'cui_str': 'Exerciser'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C1867020', 'cui_str': 'Scalp, ear, nipple syndrome'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}, {'cui': 'C0241981', 'cui_str': 'Impairment of balance'}]",78.0,0.0135271,"However, repeated applications of CWI, despite relieving muscle pain (p≤0.05), did not attenuate the loss of muscle strength, joint position senses, balance impairments, and fear of falling.","[{'ForeName': 'Aynollah', 'Initials': 'A', 'LastName': 'Naderi', 'Affiliation': 'School of Sport Science, Shahrood University of Technology, Shahrood, Semnan, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Aminian-Far', 'Affiliation': 'Neuro-muscular Rehabilitation Research Center, Rehabilitation Faculty, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Gholami', 'Affiliation': 'School of Sport Science, Shahrood University of Technology, Shahrood, Semnan, Iran.'}, {'ForeName': 'Seyed Hamed', 'Initials': 'SH', 'LastName': 'Mousavi', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Health and Sport Medicine, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Moein', 'Initials': 'M', 'LastName': 'Saghari', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Department of Sport Medicine, University of Kharazmi, Tehran, Iran.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13883']
1501,33211204,Heat and fraud: evaluating how room temperature influences fraud likelihood.,"Despite the considerable amount of research devoted to understanding fraud, few studies have examined how the physical environment can influence the likelihood of committing fraud. One recent study found a link between room brightness and occurrence of human fraud behaviors. Therefore, the present study aims to investigate how temperature may affect fraud. Based on a power analysis using the effect size observed in a pilot study, we recruited 105 participants and randomly divided them into three temperature groups (warm, medium, and cool). We then counted fraud behaviors in each group and tested for potential significant differences with a Kruskal-Wallis test. Additionally, we used a correlation analysis to determine whether the perceived temperature affected fraud. As a result, regardless of participants' subjective sensory experience or their physical environment, we did not find that temperature-related factors influence the incidence of fraud. We discussed the potential reason for the results and suggested directions for future research.",2020,"As a result, regardless of participants' subjective sensory experience or their physical environment, we did not find that temperature-related factors influence the incidence of fraud.",['105 participants'],[],[],"[{'cui': 'C4319547', 'cui_str': '105'}]",[],[],105.0,0.0221084,"As a result, regardless of participants' subjective sensory experience or their physical environment, we did not find that temperature-related factors influence the incidence of fraud.","[{'ForeName': 'Huanxu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan. ryuukansyo@gmail.com.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Graduate School of Human-Environment Studies, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Faculty of Arts and Science, Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan. yamadayuk@gmail.com.'}]",Cognitive research: principles and implications,['10.1186/s41235-020-00261-2']
1502,33207233,"Validation of an enhanced recovery after surgery protocol in gynecologic surgery: an Italian randomized study, a response.",,2020,,['gynecological surgery'],[],[],"[{'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]",[],[],,0.0609988,,"[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ferrari', 'Affiliation': 'Department of Obstetrics and Gynecology, Spedali Civili di Brescia, Piazzale Spedali Civili, 1, Brescia 25126, Italy. Electronic address: f.ferrari.obgyn@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Forte', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Odicino', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.11.009']
1503,33207242,Spinal or cortical direct current stimulation: Which is the best? Evidence from apraxia of speech in post-stroke aphasia.,"To date, new advances in technology have already shown the effectiveness of non-invasive brain stimulation and, in particular, of transcranial direct current stimulation (tDCS), in enhancing language recovery in post-stroke aphasia. More recently, it has been suggested that the stimulation over the spinal cord improves the production of words associated to sensorimotor schemata, such as action verbs. Here, for the first time, we present evidence that transpinal direct current stimulation (tsDCS) combined with a language training is efficacious for the recovery from speech apraxia, a motor speech disorder which might co-occur with aphasia. In a randomized-double blind experiment, ten aphasics underwent five days of tsDCS with concomitant treatment for their articulatory deficits in two different conditions: anodal and sham. In all patients, language measures were collected before (T0), at the end (T5) and one week after the end of treatment (F/U). Results showed that only after anodal tsDCS patients exhibited a better accuracy in repeating the treated items. Moreover, these effects persisted at F/U and generalized to other oral language tasks (i.e. picture description, noun and verb naming, word repetition and reading). A further analysis, which compared the tsDCS results with those collected in a matched group of patients who underwent the same language treatment but combined with tDCS, revealed no differences between the two groups. Given the persistency and severity of articulatory deficits in aphasia and the ease of use of tsDCS, we believe that spinal stimulation might result a new innovative approach for language rehabilitation.",2020,Results showed that only after anodal tsDCS patients exhibited a better accuracy in repeating the treated items.,[],"['Spinal or Cortical direct current stimulation', 'anodal tsDCS', 'transcranial direct current stimulation (tDCS', 'transpinal direct current stimulation (tsDCS) combined with a language training']",[],[],"[{'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023018', 'cui_str': 'Language Training'}]",[],10.0,0.117572,Results showed that only after anodal tsDCS patients exhibited a better accuracy in repeating the treated items.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pisano', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Incoccia', 'Affiliation': 'IRCCS Santa Lucia Foundation, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Marangolo', 'Affiliation': 'Department of Humanities studies - University Federico II, Naples, Italy; IRCCS Santa Lucia Foundation, Rome, Italy. Electronic address: paola.marangolo@gmail.com.'}]",Behavioural brain research,['10.1016/j.bbr.2020.113019']
1504,33207285,Rumination in the Context of Anger and Sadness: Differential Effects on State Agitation.,"BACKGROUND
Agitation is an important transdiagnostic factor for several mental health disorders and a significant risk factor for dangerous or maladaptive coping behaviors. How an individual responds to experiences of agitation itself may also play a crucial role in conferring risk towards maladaptive behaviors. Specifically, ruminating on high arousal emotions, such as anger, will also be more likely to initiate and maintain agitation, thereby increasing risk for impulsive and maladaptive behaviors.
METHODS
Undergraduate students (N=117) were randomly assigned to an emotion induction condition (i.e., control, sadness only, anger only, sadness and anger) followed by either a control condition or a rumination induction. They completed measures on subjective emotional state and agitation at baseline, after emotion induction, after rumination induction, and at the end of session.
RESULTS
Agitation was influenced by negative affect broadly with each experimental condition leading to agitation. Anger influenced momentary change in agitation and sustained agitation when combined with rumination.
LIMITATIONS
The majority of participants in the current study were young, white females and the findings may not generalize to individuals of diverse genders and cultures who may have experience and cope with agitation differently.
CONCLUSIONS
Recognizing and mitigating rumination during moments of anger may help decrease a clients' use of problematic coping behaviors.",2020,"Anger influenced momentary change in agitation and sustained agitation when combined with rumination.
",['Undergraduate students (N=117'],"['emotion induction condition (i.e., control, sadness only, anger only, sadness and anger) followed by either a control condition or a rumination induction']",['subjective emotional state and agitation'],"[{'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}]",117.0,0.0661074,"Anger influenced momentary change in agitation and sustained agitation when combined with rumination.
","[{'ForeName': 'Keyne C', 'Initials': 'KC', 'LastName': 'Law', 'Affiliation': 'Seattle Pacific University. Electronic address: Lawk3@spu.edu.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Rogers', 'Affiliation': 'Florida State University; Alpert Medical School of Brown University.'}, {'ForeName': 'Raymond P', 'Initials': 'RP', 'LastName': 'Tucker', 'Affiliation': 'Louisiana State University.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Bauer', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Capron', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Anestis', 'Affiliation': 'University of Southern Mississippi.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Joiner', 'Affiliation': 'Florida State University.'}]",Journal of affective disorders,['10.1016/j.jad.2020.11.071']
1505,33207566,Influence of Health Related Fitness on the Morphofunctional Condition of Second Mature Aged Women.,"To analyze the influence of health-related fitness on the condition of second mature aged women. Participants: 65 women divided into two groups. Group 1-40 women, (43.33 ± 0.93) years old and group 2-25 women (44.40 ± 0.93) years old. The participants trained for 8 months, three times a week for 1 h. Group 1 trained dance aerobics (Monday), strength fitness (Wednesday) and stretching (Friday). Group 2 trained only stretching. The body length and mass, handgrip strength test, vital capacity, blood pressure, heart rate, Stange and Genchi tests, and motion amplitude in joints were evaluated before and after the program. The significance of the differences between the groups was evaluated by Student's criterion (t) and Rosenbaum (Q). The different intensity of the health-related effect was confirmed at the end of the program. Physiometric indicators significantly increased in group 1. The complex physical activity led to a decrease in heart rate. The results of the Stange and Genchi tests significantly increased. Goniometric indicators of group 2 increased. The comparative analysis of the participants indicators confirms the generalized and higher health-related effect of the complex fitness program. The effect of such a program showed an increase of the adaptive potential, a significant increase in the functional capabilities of women, and the optimization of the studied indicators. With the same time expenditure for health-related fitness, the complex program has a more multifaceted effect in comparison with stretching.",2020,Physiometric indicators significantly increased in group 1.,"['Participants', 'Second Mature Aged Women', 'second mature aged women', 'Group 1-40 women, (43.33 ± 0.93) years old and group 2-25 women (44.40 ± 0.93) years old', '65 women divided into two groups']","['trained dance aerobics (Monday), strength fitness (Wednesday) and stretching (Friday']","['Physiometric indicators', 'body length and mass, handgrip strength test, vital capacity, blood pressure, heart rate, Stange and Genchi tests, and motion amplitude in joints', 'heart rate']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4517486', 'cui_str': '0.93'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0585029', 'cui_str': 'Friday'}]","[{'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0221097', 'cui_str': 'Length of body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0444497', 'cui_str': 'In joint'}]",65.0,0.0204412,Physiometric indicators significantly increased in group 1.,"[{'ForeName': 'Olha', 'Initials': 'O', 'LastName': 'Podrihalo', 'Affiliation': 'Department of Biological Science, Kharkiv State Academy of Physical Culture, 61022 Kharkiv, Ukraine.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Savina', 'Affiliation': 'Department of Dance Sports, Fitness and Gymnastics, Kharkiv State Academy of Physical, 61022 Kharkiv, Ukraine.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Podrigalo', 'Affiliation': 'Department of Medical Science, Kharkiv State Academy of Physical Culture, 61022 Kharkiv, Ukraine.'}, {'ForeName': 'Sergii', 'Initials': 'S', 'LastName': 'Iermakov', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sports, 80-336 Gdansk, Poland.'}, {'ForeName': 'Władysław', 'Initials': 'W', 'LastName': 'Jagiełło', 'Affiliation': 'Department of Sport, Gdansk University of Physical Education and Sports, 80-336 Gdansk, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Rydzik', 'Affiliation': 'Institute of Sport Sciences, University of Physical Education in Krakow, 31-541 Kraków, Poland.'}, {'ForeName': 'Wiesław', 'Initials': 'W', 'LastName': 'Błach', 'Affiliation': 'Department of Sport, University School of Physical Education, 51-612 Wroclaw, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17228465']
1506,33207811,The Effect of Smartphone-Based Cognitive Training on the Functional/Cognitive Markers of Schizophrenia: A One-Year Randomized Study.,"BACKGROUND
Cognitive impairment is associated with long-term disability that results in the deterioration of both the social and professional status of individuals with schizophrenia. The impact of antipsychotic therapy on cognitive function is insufficient. Cognitive training is therefore proposed as a tool for cognitive rehabilitation in schizophrenia. In this study we investigated the effect of self-administered cognitive training using a smartphone-based application on the cognitive function of paranoid schizophrenia patients focusing on response time, correct answer rate, incorrect answer rate, and fatigability to check, if these functions can be functional markers of successful cognitive-smartphone rehabilitation.
METHODS
1-year multicenter, open-label randomized study was conducted on 290 patients in a state of symptomatic remission. 191 patients were equipped with the full version of the application and conducted cognitive training twice a week. Reference group ( n = 99) was provided with a version of the application having only limited functionality, testing the cognitive performance of patients every 6 months.
RESULTS
Statistically significant improvement was observed in both the rate of correct answers (by 4.8%, p = 0.0001), and cognitive fatigability (by 2.9%, p = 0.0001) in the study group, along with a slight improvement in the rate of incorrect answers (by 0.9%, p = 0.15). In contrast, the reference group, who performed cognitive training every 6 months, demonstrated no significant changes in any cognitive activities.
CONCLUSIONS
Cognitive trainings facilitated by a smartphone-based application, performed regularly for a longer period of time are feasible and may have the potential to improve the cognitive functioning of individuals with schizophrenia. Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.",2020,Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.,"['paranoid schizophrenia patients', 'schizophrenia patients', 'Schizophrenia', 'individuals with schizophrenia', '290 patients in a state of symptomatic remission', '191 patients']","['self-administered cognitive training', 'smartphone-based application', 'Cognitive training', 'antipsychotic therapy', 'Smartphone-Based Cognitive Training']","['rate of correct answers', 'rate of incorrect answers', 'cognitive activities', 'cognitive fatigability']","[{'cui': 'C0036349', 'cui_str': 'Paranoid schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}]",290.0,0.0268362,Correct answers and cognitive fatigability have potential to be functional markers of successful smartphone-based psychiatric rehabilitations in schizophrenia patients.,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Krzystanek', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Krysta', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Borkowski', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Skałacka', 'Affiliation': 'Institute of Psychology, University of Opole, Kopernika 11A Street, 45-040 Opole, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Przybyło', 'Affiliation': 'Multispecialistic Voivodship Medical Clinic in Katowice, Lompy 16, 40-038 Katowice, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Pałasz', 'Affiliation': 'Department of Histology, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Medyków 18, 40-752 Katowice, Poland.'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Mucic', 'Affiliation': 'The Little Prince Treatment Centre, Havneholmen 82, 5th, V 1561 Copenhagen, Denmark.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Martyniak', 'Affiliation': 'Clinic of Psychiatric Rehabilitation, Department of Psychiatry and Psychotherapy, Faculty of Medical Sciences, Medical University of Silesia in Katowice, Ziołowa 45/47, 40-635 Katowice, Poland.'}, {'ForeName': 'Napoleon', 'Initials': 'N', 'LastName': 'Waszkiewicz', 'Affiliation': 'Department of Psychiatry, Medical University of Białystok, Plac Brodowicza 1 Str., 16-070 Choroszcz, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9113681']
1507,33207828,"Safety and Tolerability of SRX246, a Vasopressin 1a Antagonist, in Irritable Huntington's Disease Patients-A Randomized Phase 2 Clinical Trial.","SRX246 is a vasopressin (AVP) 1a receptor antagonist that crosses the blood-brain barrier. It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials. The present study was a 3-arm, multicenter, randomized, placebo-controlled, double-blind, 12-week, dose escalation study of SRX246 in early symptomatic Huntington's disease (HD) patients with irritability. Our goal was to determine whether SRX246 was safe and well tolerated in these HD patients given its potential use for the treatment of problematic neuropsychiatric symptoms. Participants were randomized to receive placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246. Assessments included standard safety tests, the Unified Huntington's Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors. The groups had comparable demographics, features of HD and baseline irritability. Eighty-two out of 106 subjects randomized completed the trial on their assigned dose of drug. One-sided exact-method confidence interval tests were used to reject the null hypothesis of inferior tolerability or safety for each dose group vs. placebo. Apathy and suicidality were not affected by SRX246. Most adverse events in the active arms were considered unlikely to be related to SRX246. The compound was safe and well tolerated in HD patients and can be moved forward as a candidate to treat irritability and aggression.",2020,"It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials.","['Eighty-two out of 106 subjects', ""early symptomatic Huntington's disease (HD) patients with irritability"", ""Irritable Huntington's Disease Patients""]","['placebo or to escalate to 120 mg twice daily or 160 mg twice daily doses of SRX246', 'placebo', 'SRX246', 'SRX246, a Vasopressin 1a Antagonist']","[""standard safety tests, the Unified Huntington's Disease Rating Scale (UHDRS), and exploratory measures of problem behaviors"", 'Apathy and suicidality', 'Safety and Tolerability', 'safe and well tolerated', 'HD and baseline irritability', 'impulsive aggression, fear, depression and anxiety']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C3713502', 'cui_str': 'SRX246'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0858853', 'cui_str': 'Impulsive aggression'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",106.0,0.171041,"It reduced impulsive aggression, fear, depression and anxiety in animal models, blocked the actions of intranasal AVP on aggression/fear circuits in an experimental medicine fMRI study and demonstrated excellent safety in Phase 1 multiple-ascending dose clinical trials.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Brownstein', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Neal G', 'Initials': 'NG', 'LastName': 'Simon', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Long', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Yankey', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Hilda T', 'Initials': 'HT', 'LastName': 'Maibach', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Merit', 'Initials': 'M', 'LastName': 'Cudkowicz', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Coffey', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Conwit', 'Affiliation': 'National Institutes of Health, NINDS, Bethesda, MD 20852, USA.'}, {'ForeName': 'Codrin', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'National Institutes of Health, NINDS, Bethesda, MD 20852, USA.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurology, Medstar Georgetown University Hospital, Washington, DC 20007, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Hersch', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Dixie J', 'Initials': 'DJ', 'LastName': 'Ecklund', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Eve M', 'Initials': 'EM', 'LastName': 'Damiano', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Debra E', 'Initials': 'DE', 'LastName': 'Itzkowitz', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Shifang', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Azevan Pharmaceuticals, Inc., Bethlehem, PA 18015, USA.'}, {'ForeName': 'Marianne K', 'Initials': 'MK', 'LastName': 'Chase', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ 85013, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McGarry', 'Affiliation': 'Department of Neurology, Cooper University Hospital, Camden, NJ 08103, USA.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Thornell', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gladden', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Costigan', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': ""O'Suilleabhain"", 'Affiliation': 'Department of Neurology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Marshall', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Chesire', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Deritis', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Adams', 'Affiliation': 'Department of Neurology, University of Rochester Medical Center, Rochester, NY 14618, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Vanderbilt University, Nashville, TN 37212, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lowen', 'Affiliation': 'Department of Neurology, Vanderbilt University, Nashville, TN 37212, USA.'}, {'ForeName': 'H Diana', 'Initials': 'HD', 'LastName': 'Rosas', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Amie L', 'Initials': 'AL', 'LastName': 'Hiller', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Quinn', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Keith', 'Affiliation': 'Department of Neurology, Oregon Health and Science University, Portland, OR 97239, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Gruenwald', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Molloy', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Jacob', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, OH 45219, USA.'}, {'ForeName': 'Stewart', 'Initials': 'S', 'LastName': 'Factor', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Sperin', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Bega', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Zsazsa R', 'Initials': 'ZR', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Seeberger', 'Affiliation': 'Department of Neurology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Victor W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Department of Neurology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Benge', 'Affiliation': 'Department of Neurology, The University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Sandra K', 'Initials': 'SK', 'LastName': 'Kostyk', 'Affiliation': 'Department of Neurology, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Daley', 'Affiliation': 'Department of Neurology, Ohio State University, Columbus, OH 43210, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Perlman', 'Affiliation': 'Department of Neurology, University of California Los Angeles, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Suski', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Conlon', 'Affiliation': 'Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Barrett', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Lowenhaupt', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Quigg', 'Affiliation': 'Department of Neurology, Virginia Commonwealth University, Richmond, VA 23298, USA.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Perlmutter', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, MO 63110, USA.'}, {'ForeName': 'Brenton A', 'Initials': 'BA', 'LastName': 'Wright', 'Affiliation': 'Department of Neurosciences, University of California San Diego, La Jolla, CA 92121, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Most', 'Affiliation': 'Department of Neurology, Washington University, Saint Louis, MO 63110, USA.'}, {'ForeName': 'Guy J', 'Initials': 'GJ', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neurology, Stony Brook University Hospital, Stony Brook, NY 11794, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lamb', 'Affiliation': 'Department of Neurology, Stony Brook University Hospital, Stony Brook, NY 11794, USA.'}, {'ForeName': 'Rosalind S', 'Initials': 'RS', 'LastName': 'Chuang', 'Affiliation': 'Department of Neurology, Swedish Medical Center, Seattle, WA 98122, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Singer', 'Affiliation': 'Department of Neurology, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Marder', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Moran', 'Affiliation': 'Department of Neurology, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Singleton', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Zorn', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Paola V', 'Initials': 'PV', 'LastName': 'Wall', 'Affiliation': 'Clinical Neurosciences Center, University of Utah, Salt Lake City, UT 84132, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Dubinsky', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS 66160, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Gray', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS 66160, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Drazinic', 'Affiliation': 'Department of Clinical Sciences, Florida State University, Tallahassee, FL 32306, USA.'}]",Journal of clinical medicine,['10.3390/jcm9113682']
1508,33207841,Effect of Using an 8-Figure Shoulder Brace on Posture and Muscle Activities during the Performance of Dental Hygiene Procedures.,"The incidence of work-related musculoskeletal disorders (MSDs) among dental workers has been increasing. Many ergonomic devices and accessories have been introduced. The aim of this study was to investigate the effects of an 8-figure shoulder brace on posture-related muscle activities in dental hygiene practitioners during scaling procedures. In this study, 33 participants (age: 21.9 ± 2.1 years, height: 162.0 ± 6.0 cm, weight: 55.8 ± 9.0 kg, body mass index: 21.2 ± 2.4 kg/m 2 ) performed the scaling procedure with and without the 8-figure shoulder brace in a randomized order. The normalized electromyography activity in the amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints) were simultaneously recorded during scaling. A paired t test was used to compare the differences in muscle kinematics, with the alpha level set at 0.05. The dental hygienists who wore the 8-figure shoulder brace during scaling showed thoracic and lumbar extension, improved sitting postures, and reduced shoulder joint abduction. However, we also observed an unintended increase in internal rotation. Use of the 8-figure shoulder brace could prevent work-related MSDs in lumbar and thoracic regions by reducing the effort exerted by the upper trapezius and deltoid muscles, despite the increased muscular effort of the cervical erector spinae.",2020,"The normalized electromyography activity in the amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints) were simultaneously recorded during scaling.","['dental hygiene practitioners during scaling procedures', '33 participants (age: 21.9 ± 2.1 years, height: 162.0 ± 6.0 cm, weight: 55.8 ± 9.0 kg, body mass index: 21.2 ± 2.4 kg/m 2 ) performed the']","['8-Figure Shoulder Brace', 'scaling procedure with and without the 8-figure shoulder brace', '8-figure shoulder brace']","['Posture and Muscle Activities', 'thoracic and lumbar extension, improved sitting postures, and reduced shoulder joint abduction', 'internal rotation', 'amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints', 'normalized electromyography activity']","[{'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",33.0,0.0249432,"The normalized electromyography activity in the amplitude probability distribution function and joint angles (cervical, thoracic, lumbar, and shoulder joints) were simultaneously recorded during scaling.","[{'ForeName': 'Tae-Lim', 'Initials': 'TL', 'LastName': 'Yoon', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Sciences, Cheongju University, Cheongju 28503, Korea.'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Dental Hygiene, College of Health and Medical Sciences, Cheongju University, Cheongju 28503, Korea.'}, {'ForeName': 'Han-Na', 'Initials': 'HN', 'LastName': 'Kim', 'Affiliation': 'Department of Dental Hygiene, College of Health and Medical Sciences, Cheongju University, Cheongju 28503, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17228494']
1509,33208330,Predicting treatment outcomes for bilinguals with aphasia using computational modeling: Study protocol for the PROCoM randomised controlled trial.,"INTRODUCTION
Bilinguals with aphasia (BWA) present varying degrees of lexical access impairment and recovery across their two languages. Because both languages may benefit from therapy, identifying the optimal target language for treatment is a current challenge for research and clinical practice. Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia. Here, we aim to determine whether BiLex can predict treatment outcomes in BWA in the treated and the untreated language and compare these outcome predictions to determine the optimal language for rehabilitation.
METHODS AND ANALYSIS
The study involves a prospective parallel-group, double-blind, randomised controlled trial. Forty-eight Spanish-English BWA will receive 20 sessions of semantic treatment for lexical retrieval deficits in one of their languages and will complete assessments in both languages prior and after treatment. Participants will be randomly assigned to an experimental group receiving treatment in the optimal language determined by the model or a control group receiving treatment in the language opposite to the model's recommendation. Primary treatment outcomes include naming probes while secondary treatment outcomes include tests tapping additional language domains. Treatment outcomes will be compared across the two groups using 2×2 mixed effect models for repeated measures Analysis of variance (ANOVA) on metrics of treatment effects commonly employed in rehabilitation studies (ie, effect size and percentage change).
ETHICS AND DISSEMINATION
All procedures included in this protocol (protocol number 29, issue date: 19 March 2019) were approved by the Boston University Charles River Campus Institutional Review Board at Boston, Massachusetts (reference number: 4492E). The results of this study will be published in peer-reviewed scientific journals and will be presented at national and international conferences.
TRIAL REGISTRATION NUMBER
NCT02916524.",2020,"Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia.","['All procedures included in this protocol (protocol number 29, issue date: 19 March 2019) were approved by the Boston University Charles River Campus Institutional Review Board at Boston, Massachusetts (reference number: 4492E']","['BiLex', ""experimental group receiving treatment in the optimal language determined by the model or a control group receiving treatment in the language opposite to the model's recommendation""]","['rehabilitation studies (ie, effect size and percentage change', 'naming probes while secondary treatment outcomes include tests tapping additional language domains']","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0337050', 'cui_str': 'River'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1514830', 'cui_str': 'Rehabilitation Research'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",48.0,0.214576,"Prior research has demonstrated that the BiLex computational model can accurately simulate lexical access in healthy bilinguals, and language impairment and treatment response in bilingual aphasia.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Peñaloza', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA penaloza@bu.edu.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dekhtyar', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scimeca', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Carpenter', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Nishaat', 'Initials': 'N', 'LastName': 'Mukadam', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Kiran', 'Affiliation': 'Aphasia Research Laboratory, Department of Speech, Language and Hearing Sciences, Boston University, Boston, Massachusetts, USA.'}]",BMJ open,['10.1136/bmjopen-2020-040495']
1510,33171595,PROVIT: Supplementary Probiotic Treatment and Vitamin B7 in Depression-A Randomized Controlled Trial.,"Gut microbiota are suspected to affect brain functions and behavior as well as lowering inflammation status. Therefore, an effect on depression has already been suggested by recent research. The aim of this randomized double-blind controlled trial was to evaluate the effect of probiotic treatment in depressed individuals. Within inpatient care, 82 currently depressed individuals were randomly assigned to either receive a multistrain probiotic plus biotin treatment or biotin plus placebo for 28 days. Clinical symptoms as well as gut microbiome were analyzed at the begin of the study, after one and after four weeks. After 16S rRNA analysis, microbiome samples were bioinformatically explored using QIIME, SPSS, R and Piphillin. Both groups improved significantly regarding psychiatric symptoms. Ruminococcus gauvreauii and Coprococcus 3 were more abundant and β-diversity was higher in the probiotics group after 28 days. KEGG-analysis showed elevated inflammation-regulatory and metabolic pathways in the intervention group. The elevated abundance of potentially beneficial bacteria after probiotic treatment allows speculations on the functionality of probiotic treatment in depressed individuals. Furthermore, the finding of upregulated vitamin B6 and B7 synthesis underlines the connection between the quality of diet, gut microbiota and mental health through the regulation of metabolic functions, anti-inflammatory and anti-apoptotic properties. Concluding, four-week probiotic plus biotin supplementation, in inpatient individuals with a major depressive disorder diagnosis, showed an overall beneficial effect of clinical treatment. However, probiotic intervention compared to placebo only differed in microbial diversity profile, not in clinical outcome measures.",2020,Ruminococcus gauvreauii and Coprococcus 3 were more abundant and β-diversity was higher in the probiotics group after 28 days.,"['inpatient individuals with a major depressive disorder diagnosis', '82 currently depressed individuals', 'depressed individuals']","['Supplementary Probiotic Treatment and Vitamin B7', 'probiotic intervention', 'placebo', 'PROVIT', 'probiotic plus biotin supplementation', 'probiotic treatment', 'multistrain probiotic plus biotin treatment or biotin plus placebo']","['elevated inflammation-regulatory and metabolic pathways', 'microbial diversity profile', 'psychiatric symptoms']","[{'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4552467', 'cui_str': 'Biotin supplementation'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1291081', 'cui_str': 'Metabolic pathway'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}]",82.0,0.195707,Ruminococcus gauvreauii and Coprococcus 3 were more abundant and β-diversity was higher in the probiotics group after 28 days.,"[{'ForeName': 'Eva Z', 'Initials': 'EZ', 'LastName': 'Reininghaus', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Platzer', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kohlhammer-Dohr', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Mörkl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Susanne A', 'Initials': 'SA', 'LastName': 'Bengesser', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Frederike T', 'Initials': 'FT', 'LastName': 'Fellendorf', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Theressa', 'Initials': 'T', 'LastName': 'Lahousen-Luxenberger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Leitner-Afschar', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Schöggl', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Amberger-Otti', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Wurm', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Queissner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Birner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Valerie S', 'Initials': 'VS', 'LastName': 'Falzberger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Painold', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Fitz', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Jolana', 'Initials': 'J', 'LastName': 'Wagner-Skacel', 'Affiliation': 'Department of Medical Psychology and Psychosomatics, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brunnmayr', 'Affiliation': 'TZ-Justus Park, 4540 Bad Hall, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rieger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Maget', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Unterweger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schwalsberger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Reininghaus', 'Affiliation': 'TZ-Justus Park, 4540 Bad Hall, Austria.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Lenger', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Thomaz F S', 'Initials': 'TFS', 'LastName': 'Bastiaanssen', 'Affiliation': 'Department of Anatomy and Neuroscience, University College Cork, T12 YN60 Cork, Ireland.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Dalkner', 'Affiliation': 'Department of Psychiatry and Psychotherapeutic Medicine, Medical University of Graz, 8036 Graz, Austria.'}]",Nutrients,['10.3390/nu12113422']
1511,33171597,Effect of Korean Red Ginseng on Cholesterol Metabolites in Postmenopausal Women with Hypercholesterolemia: A Pilot Randomized Controlled Trial.,"Korean red ginseng (KRG) is known to exert beneficial effects on cardiovascular health. Meanwhile, reduced estrogen at menopause has been shown to have various adverse impacts on cardiovascular risk factors, including blood lipids. The aim of this pilot study was to investigate the effect of KRG on cholesterol metabolites, which are surrogate markers of cholesterol absorption and biosynthesis, in postmenopausal women with hypercholesterolemia. The present study is an exploratory study which used data from a 4-week, double-blinded, placebo-controlled clinical pilot study in 68 postmenopausal women with hypercholesterolemia. Patients received KRG (2 g) or placebo (2 g) once daily. The primary endpoints were changes in the levels of nine sterols. Serum sterols were analyzed using liquid chromatography-mass spectrometry (LC-MS)/MS analysis. Among the sterols, reduction in cholesterol level were significantly larger in the KRG group than in the placebo group (the changes: -148.3 ± 261.1 nmol/mL in the ginseng group vs. -23.0 ± 220.5 nmol/mL in the placebo group, p = 0.039). Additionally, changes in 7-hydroxycholesterol (7-OHC) were significantly larger in the KRG group than in the placebo group (the changes: -0.05 ± 0.09 nmol/mL in the ginseng group vs. -0.002 ± 0.1 nmol/mL in the placebo group, p = 0.047). Oxysterols, cholesterol derivates, have been known to play a role in chronic inflammation diseases such as cardiovascular diseases. KRG improves sterol metabolism by decreasing cholesterol and 7-OHC levels in postmenopausal women with hypercholesterolemia.",2020,"Additionally, changes in 7-hydroxycholesterol (7-OHC) were significantly larger in the KRG group than in the placebo group (the changes: -0.05 ± 0.09 nmol/mL in the ginseng group vs. -0.002 ± 0.1 nmol/mL in the placebo group, p = 0.047).","['postmenopausal women with hypercholesterolemia', '68 postmenopausal women with hypercholesterolemia', 'Postmenopausal Women with Hypercholesterolemia']","['KRG', 'Korean red ginseng (KRG', 'Korean Red Ginseng', 'placebo']","['levels of nine sterols', 'cholesterol and 7-OHC levels', 'sterol metabolism', 'changes in 7-hydroxycholesterol (7-OHC', 'Cholesterol Metabolites', 'reduction in cholesterol level']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020339', 'cui_str': 'Hydroxycholesterols'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",68.0,0.292853,"Additionally, changes in 7-hydroxycholesterol (7-OHC) were significantly larger in the KRG group than in the placebo group (the changes: -0.05 ± 0.09 nmol/mL in the ginseng group vs. -0.002 ± 0.1 nmol/mL in the placebo group, p = 0.047).","[{'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Family Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin 16995, Korea.'}, {'ForeName': 'Su-Nyeong', 'Initials': 'SN', 'LastName': 'Jang', 'Affiliation': 'BK21 Plus KNU Multi-Omics based Creative Drug Research Team, College of Pharmacy and Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu 41566, Korea.'}, {'ForeName': 'Kwang-Hyeon', 'Initials': 'KH', 'LastName': 'Liu', 'Affiliation': 'College of Pharmacy and Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu 41566, Korea.'}, {'ForeName': 'Dong-Hyuk', 'Initials': 'DH', 'LastName': 'Jung', 'Affiliation': 'Department of Family Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin 16995, Korea.'}]",Nutrients,['10.3390/nu12113423']
1512,33180026,REMOTION Blended Transdiagnostic Intervention for Symptom Reduction and Improvement of Emotion Regulation in an Outpatient Psychotherapeutic Setting: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND
Emotion regulation has been identified as an important transdiagnostic factor relevant to the treatment of mental health disorders. Many empirically validated psychotherapeutic treatments incorporate elements targeting emotion regulation. Most of these treatment approaches are conceptualized as standard face-to-face treatments not as blended treatments, which include an internet-based intervention.
OBJECTIVE
The aim of this study is to examine, for the first time, a new internet-based intervention-REMOTION-that will be provided transdiagnostically, as an add-on to psychotherapy, to provide a blended treatment format.
METHODS
A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone. To maximize external validity, a typical outpatient treatment sample of patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic. Patients with bipolar disorder, psychotic disorders, or acute suicidality will be excluded from the study. The feasibility and potential effectiveness of the intervention will be examined by assessing data at baseline, 6 weeks (post), and 12 weeks (follow-up). The primary outcome is general symptom severity, assessed with the Brief Symptom Inventory. Secondary outcomes are emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters. Quantitative data will be analyzed on an intention-to-treat basis.
RESULTS
Participant recruitment and data collection started in February 2020, and as of November 2020, are ongoing. Results for the study are expected in 2022.
CONCLUSIONS
This pilot randomized controlled trial will inform future studies using transdiagnostic blended treatment.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04262726; http://clinicaltrials.gov/ct2/show/NCT04262726.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/20936.",2020,A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone.,"['Patients with bipolar disorder, psychotic disorders, or acute suicidality will be excluded from the study', '70 participants', 'patients diagnosed with a range of disorders such as depression, anxiety disorders, and adjustment disorder will be recruited from a university outpatient clinic']","[' psychotherapy) or the treatment-as-usual group that receives psychotherapy alone', 'Blended Transdiagnostic Intervention']","['emotion regulation, depressive symptoms, anxiety symptoms, health related quality of life, well-being, and a variety of feasibility parameters', 'general symptom severity, assessed with the Brief Symptom Inventory', 'Emotion Regulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001546', 'cui_str': 'Adjustment disorder'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",70.0,0.154187,A total of 70 participants will be assigned (1:1 allocation ratio) to either the intervention group (REMOTION + psychotherapy) or the treatment-as-usual group that receives psychotherapy alone.,"[{'ForeName': 'Laura Luisa', 'Initials': 'LL', 'LastName': 'Bielinski', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Moggi', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Trimpop', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Willutzki', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nissen', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}]",JMIR research protocols,['10.2196/20936']
1513,33180028,A Mobile Health Mindfulness Intervention for Women With Moderate to Moderately Severe Postpartum Depressive Symptoms: Feasibility Study.,"BACKGROUND
Approximately 20% of women suffer from postpartum depression (PPD). Due to barriers such as limited access to care, half of the women with PPD do not receive treatment. Therefore, it is critical to identify effective and scalable interventions. Traditional mindfulness programs have been effective in reducing depressive symptoms, however access remains a barrier. A self-paced mobile health (mHealth) mindfulness program may fit the lifestyle of busy mothers who are unable to attend in-person classes. However, little is known regarding the feasibility or efficacy of mHealth mindfulness interventions in postpartum women with depressive symptoms.
OBJECTIVE
This study aims to assess the feasibility, acceptability, and preliminary efficacy of an mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms.
METHODS
We conducted a single-arm feasibility trial of an mHealth mindfulness intervention within Kaiser Permanente Northern California (KPNC), a large integrated health care system. Participants were identified through clinician referral and electronic health records via KPNC's universal perinatal depression screening program and recruited by the study team. Inclusion criteria included the following: English-speaking, up to 6 months postpartum with a Patient Health Questionnaire (PHQ-8) score of 10 to 19, and no regular mindfulness/meditation practice. Participants were asked to use a mindfulness app, Headspace, 10 to 20 min/day for 6 weeks. Baseline and postintervention surveys captured data on patient-reported outcomes (depression and stress symptoms, sleep quality, and mindfulness). Semistructured interviews captured acceptability. Retention and adherence were used to assess feasibility.
RESULTS
Of the 115 women who were contacted and met the eligibility criteria or declined participation before eligibility assessment, 27 (23%) were enrolled. In addition, 70% (19/27) completed the study. The mean age of participants was 31 years (SD 5.2), 30% (8/27) were non-Hispanic White, and, on average, participants were 12.3 weeks postpartum (SD 5.7). Of the women who completed the study, 100% (19/19) used the Headspace app at least once, and nearly half (9/19, 47%) used the app on ≥50% of the days during the 6-week intervention period. Of the 16 participants who completed the postintervention interview, 69% (11/16) reported that they were very or extremely satisfied with the app. Interviews indicated that women appreciated the variety of meditations and felt that the program led to reduced anxiety and improved sleep. Significant improvements in pre- and postintervention scores were observed for depressive symptoms (PHQ-8: -3.8, P=.004), perceived stress (10-item Perceived Stress Scale: -6.0, P=.005), and sleep quality (Pittsburgh Sleep Quality Index: -2.1, P=.02, indicating less sleep disturbance). Improvements in mindfulness were also significant (Five Facet Mindfulness Questionnaire-Short Form: 10.9, P=.01).
CONCLUSIONS
An mHealth mindfulness intervention for postpartum women with moderate to moderately severe depressive symptoms is feasible and acceptable. An efficacy trial is warranted.",2020,Significant improvements in pre- and postintervention scores were observed for depressive symptoms (PHQ-8:,"['Women With Moderate to Moderately Severe Postpartum Depressive Symptoms', 'postpartum women with depressive symptoms', 'Inclusion criteria included the following: English-speaking, up to 6 months postpartum with a Patient Health Questionnaire (PHQ-8) score of 10 to 19, and no regular mindfulness/meditation practice', 'busy mothers who are unable to attend in-person classes', '16 participants who completed the postintervention interview, 69% (11/16) reported that they were very or extremely satisfied with the app', 'The mean age of participants was 31 years (SD 5.2), 30% (8/27) were non-Hispanic White, and, on average, participants were 12.3 weeks postpartum (SD 5.7', 'women suffer from postpartum depression (PPD', ""Participants were identified through clinician referral and electronic health records via KPNC's universal perinatal depression screening program and recruited by the study team"", 'Kaiser Permanente Northern California (KPNC', '115 women who were contacted and met the eligibility criteria or declined participation before eligibility assessment, 27 (23%) were enrolled', 'postpartum women with moderate to moderately severe depressive symptoms']","['mHealth mindfulness interventions', 'self-paced mobile health (mHealth) mindfulness program', 'Mobile Health Mindfulness Intervention', 'mHealth mindfulness intervention']","['sleep quality (Pittsburgh Sleep Quality Index', 'reduced anxiety and improved sleep', 'outcomes (depression and stress symptoms, sleep quality, and mindfulness', 'perceived stress (10-item Perceived Stress Scale', 'feasibility, acceptability', 'depressive symptoms', 'pre- and postintervention scores', 'sleep disturbance', 'depressive symptoms (PHQ-8']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0559477', 'cui_str': 'Perinatal asphyxia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}]",115.0,0.102491,Significant improvements in pre- and postintervention scores were observed for depressive symptoms (PHQ-8:,"[{'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Avalos', 'Affiliation': 'Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aghaee', 'Affiliation': 'Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Kurtovich', 'Affiliation': 'Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Quesenberry', 'Affiliation': 'Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nkemere', 'Affiliation': 'Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States.'}, {'ForeName': 'MegAnn K', 'Initials': 'MK', 'LastName': 'McGinnis', 'Affiliation': 'Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States.'}, {'ForeName': 'Ai', 'Initials': 'A', 'LastName': 'Kubo', 'Affiliation': 'Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States.'}]",JMIR mental health,['10.2196/17405']
1514,31804571,Associations between echocardiographic findings and prospective changes in residual renal function in patients new to peritoneal dialysis.,"Although echocardiograms are often performed when peritoneal dialysis is started, associations between commonly reported findings and prospective changes in renal function remain understudied. Ninety-nine of 101 patients in the Trio Trial had transthoracic echocardiograms within 6 months of dialysis initiation, and measurements of residual renal function every six weeks for up to two years. Generalized mixed modelling linear regression in STATA was used to examine associations between left atrial size, left ventricular hypertrophy, left ventricular ejection fraction, right ventricular systolic pressure, and left valvular calcification with subsequent slopes in renal function. After echocardiography (performed a median of 16 days following peritoneal dialysis initiation) right ventricular systolic pressure was associated with faster, while declining left ventricular ejection fraction and valvular calcification were associated with slower declines in residual renal function. Future studies could be conducted to confirm these findings, and identify pathophysiological mechanisms.",2019,"Ninety-nine of 101 patients in the Trio Trial had transthoracic echocardiograms within 6 months of dialysis initiation, and measurements of residual renal function every six weeks for up to two years.","['patients new to peritoneal dialysis', 'Ninety-nine of 101 patients in the Trio Trial had transthoracic echocardiograms within 6 months of dialysis initiation, and measurements of residual renal function every six weeks for up to two years']",[],"['residual renal function', 'ventricular systolic pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}, {'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C1448979', 'cui_str': 'TRIO protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0585336', 'cui_str': 'Every six weeks'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0229006,"Ninety-nine of 101 patients in the Trio Trial had transthoracic echocardiograms within 6 months of dialysis initiation, and measurements of residual renal function every six weeks for up to two years.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mahdavi', 'Affiliation': 'Department of Nephrology, The Scarborough Hospital, Toronto, Canada.'}, {'ForeName': 'Kibar', 'Initials': 'K', 'LastName': 'Yared', 'Affiliation': 'Department of Nephrology, The Scarborough Hospital, Toronto, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Omar', 'Affiliation': 'Department of Nephrology, The Scarborough Hospital, Toronto, Canada.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Savundra', 'Affiliation': 'Department of Nephrology, The Scarborough Hospital, Toronto, Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Nagai', 'Affiliation': 'Department of Nephrology, The Scarborough Hospital, Toronto, Canada.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Hockmann', 'Affiliation': 'Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Svendrovski', 'Affiliation': 'Private Biostatistics Consultant, Toronto, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bellasi', 'Affiliation': 'Aziende Socio Sanitarie Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tam', 'Affiliation': 'Department of Nephrology, The Scarborough Hospital, Toronto, Canada.'}, {'ForeName': 'Tabo', 'Initials': 'T', 'LastName': 'Sikaneta', 'Affiliation': 'Department of Nephrology, The Scarborough Hospital, Toronto, Canada. tabosikaneta@yahoo.ca.'}]",Scientific reports,['10.1038/s41598-019-54851-2']
1515,33181631,Refractive growth variability in the Infant Aphakia Treatment Study.,"PURPOSE
Prediction of refraction after cataract surgery in children is limited by the variance in rate of refractive growth (RRG3). This study compared RRG3 in aphakic and pseudophakic eyes to their fellow, normal eyes in the Infant Aphakia Treatment Study (IATS).
SETTING
12 clinical sites in the United States.
DESIGN
Randomized clinical trial.
METHODS
Infants randomized to unilateral cataract extraction had RRG3 calculated based on biometric data (axial length and keratometry) at cataract surgery and at 10 years of age, for both the normal and cataract eyes. Subjects were included if complete biometric data from both eyes was available both at surgery and at 10 years. Variance in RRG3 was compared between the groups with Pitman's test for equality of variance between correlated samples.
RESULTS
Longitudinal biometric data was available for 103 of the 114 patients enrolled. RRG3 for normal eyes was -15.0 (3.0) D (reported as mean (standard deviation)), for aphakic eyes -17.7 (6.2) D, and for pseudophakic eyes -16.7 (6.2) D (P < 0.0001 for comparison of variances in RRG3 between normal and all operated eyes). Further analysis found differences in the variance in axial length growth (P < 0.0001) between operated and normal eyes; the variance in keratometry measurement change did not reach significance.
CONCLUSIONS
The standard deviation in the rate of refractive growth of normal eyes in our study is half of that found in eyes that underwent cataract surgery.",2020,"Further analysis found differences in the variance in axial length growth (P < 0.0001) between operated and normal eyes; the variance in keratometry measurement change did not reach significance.
","['103 of the 114 patients enrolled', 'Infants randomized to unilateral cataract extraction had RRG3 calculated based on biometric data (axial length and keratometry) at cataract surgery and at 10 years of age, for both the normal and cataract eyes', 'aphakic and pseudophakic eyes to their fellow, normal eyes in the Infant Aphakia Treatment Study (IATS', '12 clinical sites in the United States']",['RRG3'],"['FRefractive growth variability', 'axial length growth']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521706', 'cui_str': 'Unilateral cataract'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0003534', 'cui_str': 'Aphakia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0424639', 'cui_str': 'Height / growth measure'}]",114.0,0.0800196,"Further analysis found differences in the variance in axial length growth (P < 0.0001) between operated and normal eyes; the variance in keratometry measurement change did not reach significance.
","[{'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'McClatchey', 'Affiliation': 'Department of Ophthalmology, Naval Medical Center, San Diego, CA.'}, {'ForeName': 'Thaddeus S', 'Initials': 'TS', 'LastName': 'McClatchey', 'Affiliation': 'Department of Ophthalmology, Naval Medical Center, San Diego, CA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Lambert', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Stanford University, Palo Alto, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000482']
1516,33185896,"Indomethacin markedly blunts cerebral perfusion and reactivity, with little cognitive consequence in healthy young and older adults.","KEY POINTS
Cognitive function depends on adequate cerebrovascular perfusion and control. However, it is unknown whether acutely-reduced cerebral blood flow (CBF) impairs cognition in healthy adults. In the present study, we used a placebo-controlled, single-blinded, randomized cross-over design to test the hypothesis that acutely-reduced CBF (using a pharmacological aid; indomethacin) would impair cognition in young and older healthy adults. At baseline, older adults had lower cognitive performance and CBF, but similar cerebrovascular reactivity to CO 2 and dynamic cerebral autoregulation compared to young adults. In both young and older adults, cognitive performance on a mental switching task was slightly (7%) reduced after indomethacin, but not significantly associated with reductions in CBF (∼31%). These results indicate that cognitive performance is broadly resilient against a ∼31% reduction in CBF per se in healthy young and older adults.
ABSTRACT
Cognitive function depends on adequate cerebrovascular perfusion and control. However, it is unknown whether acutely-reduced cerebral blood flow (CBF) impairs cognition in healthy adults. Using a placebo-controlled, single-blinded, randomized cross-over design, we tested the hypothesis that acutely-reduced CBF (using indomethacin [1.2 mg kg -1 oral dose]) would impair cognition in young (n = 13; 25 ± 4 years) and older (n = 12; 58 ± 6 years) healthy adults. CBF and cerebrovascular control were measured using middle cerebral artery blood velocity (MCAv mean ) and its reactivity to hypercapnia (CVR HYPER ) and hypocapnia (CVR HYPO ), respectively. Cognitive function was assessed using a computerized battery including response time tasks. Baseline comparisons revealed that older adults had 14% lower MCAv mean and 15% lower cognitive performance (all P ≤ 0.048), but not lower CVR HYPER/HYPO (P ≥ 0.26). Linear and rank-based mixed models revealed that indomethacin decreased MCAv mean by 31% (95% confidence interval = -35 to -26), CVR HYPER by 68% [interquartile range (IQR) = -94 to -44] and CVR HYPO by 50% (IQR = -83 to -33) (treatment-effect; all P < 0.01), regardless of age. Baseline CVR HYPER/HYPO values were strongly associated with their indomethacin-induced reductions (r = 0.70 to 0.89, P < 0.01). Mental switching performance was impaired 7% (IQR = 0-19) after indomethacin (P = 0.04), but not significantly associated with reductions in MCAv mean (Young: rho = -0.31, P = 0.30; Older: rho = 0.06, P = 0.86). In conclusion, indomethacin reduced MCAv mean and impaired cognition slightly; however, no clear association was evident in younger or older adults. Older adults had poorer cognition and lower MCAv mean , but similar CVR HYPER/HYPO .",2020,"In both young and older adults, cognitive performance on a mental switching task was slightly (7%) reduced after indomethacin, but not significantly associated with reductions in CBF (∼31%).","['Older adults', 'young (n = 13; 25±4 y) and older (n = 12; 58±6 y) healthy adults', 'healthy young and older adults', 'healthy adults', 'young and older healthy adults']","['Indomethacin', 'CVR HYPO by 50% [IQR:-83,-33', 'acutely-reduced CBF (using a pharmacological aid; indomethacin', 'placebo', 'indomethacin']","['middle cerebral artery blood velocity (MCAv mean ) and its reactivity to hypercapnia (CVR HYPER ) and hypocapnia (CVR HYPO ', 'CVR HYPER', 'cognitive performance', 'cerebrovascular reactivity to CO 2 and dynamic cerebral autoregulation', 'MCAv mean and impaired cognition', 'MCAv mean', 'cerebral blood flow (CBF) impairs cognition', 'CBF', 'Cognitive function', 'Mental switching performance', 'CBF and cerebrovascular control', 'Baseline CVR HYPER/HYPO', 'cerebral perfusion and reactivity', 'cognitive performance on a mental switching task']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0335947,"In both young and older adults, cognitive performance on a mental switching task was slightly (7%) reduced after indomethacin, but not significantly associated with reductions in CBF (∼31%).","[{'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Shoemaker', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Otago Medical School - Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'S J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'Department of Physiology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Machado', 'Affiliation': 'Department of Psychology, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': 'Department of Medicine, Otago Medical School - Dunedin Campus, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Cotter', 'Affiliation': 'School of Physical Education, Sport and Exercise Sciences, University of Otago, Dunedin, New Zealand.'}]",The Journal of physiology,['10.1113/JP280118']
1517,33185897,Combination of resistance and aerobic exercise for six months improves bone mass and physical function in HIV infected individuals: A randomized controlled trial.,"To evaluate the effect of combined resistance and aerobic training (RT+AT) on regional bone mineral density (BMD) and physical performance in people living with HIV (PLWH). Forty PLWH (20 men and 20 women) were randomized into RT+AT group (n = 20; age = 38.3 ± 4.9) or non-exercise control group (n = 20; age = 37.9 ± 5.1). The RT+AT group was required to perform a nonlinear periodized resistance training program targeting large muscle groups followed by 20 min aerobic exercise at 65-80% of maximal heart rate. Participants in RT+AT performed three supervised sessions per week for 6-months, whereas participants in the control group were instructed to continue with their current lifestyle habits. The primary outcome was bone mineral density (lumbar spine (L2-L4), femoral neck, and distal 1/3 radius). Secondary outcomes included physical function, anthropometry, inflammatory markers, and growth factors. The RT+AT group demonstrated a significant increase in BMD at follow-up for the Lumbar spine (L2-L4), femoral neck, and 1/3 radius (all, P < .05), and There were no gender differences in the training response between men and women for any of the BMD regions. Similar findings were also observed for lean body mass, IGF1and Adiponectin (P < .001). We observed a decrease in percent body fat, fat mass, IL-6, TNF-α, and myostatin in the RT+AT group (P < .001). Finally, there was a significant increase in handgrip strength and gait speed for both women and men in the RT+AT group (P < .001). A combination of resistance and aerobic training appears to be a feasible and effective means for counteracting bone loss and improving various inflammatory markers, physical function, and growth hormones in PLWH.",2020,"We observed a decrease in percent body fat, fat mass, IL-6, TNF-α, and myostatin in the RT+AT group (P <0.001).","['people living with HIV (PLWH', 'Forty PLWH (20 men and 20 women', 'group (n=20; age = 38.3 ± 4.9) or', 'HIV infected individuals']","['nonlinear periodized resistance training program targeting large muscle groups followed by 20 min aerobic exercise', 'non-exercise control group', 'RT+AT', 'resistance and aerobic training', 'combined resistance and aerobic training (RT+AT', 'resistance and aerobic exercise']","['physical function, anthropometry, inflammatory markers, and growth factors', 'handgrip strength and gait speed', 'Lumbar spine (L2-L4), femoral neck', 'percent body fat, fat mass, IL-6, TNF-α, and myostatin', 'bone mass and physical function', 'bone mineral density (lumbar spine (L2-L4), femoral neck, and distal 1/3 radius', 'lean body mass, IGF1and Adiponectin', 'BMD', 'regional bone mineral density (BMD) and physical performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0205147', 'cui_str': 'Regional'}]",,0.0591328,"We observed a decrease in percent body fat, fat mass, IL-6, TNF-α, and myostatin in the RT+AT group (P <0.001).","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Ghayomzadeh', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Health and Kinesiology, Texas A&M University College Station, College Station, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hackett', 'Affiliation': 'Physical Activity, Lifestyle, Ageing and Wellbeing Faculty Research Group, School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'SeyedAhmad', 'Initials': 'S', 'LastName': 'SeyedAlinaghi', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'James Wilfred', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Gholami', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Negin', 'Initials': 'N', 'LastName': 'Hosseini Rouzbahani', 'Affiliation': 'Department of Medical Immunology, Faculty of Medicine, Aja University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Mohraz', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fabrício Azevedo', 'Initials': 'FA', 'LastName': 'Voltarelli', 'Affiliation': ""Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Mato Grosso, Cuiab'a, Brazil.""}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13871']
1518,33185928,Tumor mutation burden as a biomarker for lung cancer patients treated with pemetrexed and cisplatin (the JIPANG-TR).,"The JIPANG study is a randomized phase III study of pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis) for completely resected stage II-IIIA non-squamous non-small cell lung cancer (Ns-NSCLC). This study did not meet the primary endpoint (recurrence-free survival, RFS) but Pem/Cis had a similar efficacy to Vnr/Cis with a better tolerability. Tumor mutation burden (TMB) is thought to have a predictive value of immune checkpoint inhibitors. However, the relevance of TMB to cytotoxic chemotherapy remains unknown. This exploratory study investigates the relationship between tumor mutation profiles and clinical outcome of Pem/Cis. Formalin-fixed, paraffin-embedded tumor tissues (n = 389) were obtained from the patients. Mutation status of tissue DNA was analyzed by targeted deep sequencing. Epidermal growth factor receptor (EGFR) mutations were detected frequently in Ns-NSCLC (139/374). Patients without any EGFR mutations experienced longer RFS in the Pem/Cis arm versus Vnr/Cis arms. Pem/Cis in patients with high TMB (≥12-16 mut/Mb) tended to have improved survival. In patients with wild-type EGFR, TMB ≥ 12 mut/Mb was significantly associated with improved RFS with Pem/Cis versus Vnr/Cis (not reached vs 52.5 months; hazard ratio (HR) 0.477). It could be proposed that TMB was predictive of RFS benefit with Pem/Cis versus Vnr/Cis in Ns-NSCLC. Further investigation is required to determine whether TMB combined with EGFR mutation status could be used as a predictive biomarker.",2020,Mb was significantly associated with improved RFS with Pem/Cis vs Vnr/Cis (not reached vs 52.5 months; hazard ratio (HR) 0.477).,"['lung cancer patients treated with', 'completely resected stage II-IIIA non-squamous non-small cell lung cancer (Ns-NSCLC']","['pemetrexed/cisplatin (Pem/Cis) versus vinorelbine/cisplatin (Vnr/Cis', 'pemetrexed and cisplatin', 'Pem/Cis', 'Formalin-fixed, paraffin-embedded tumor tissues']","['Mutation status of tissue DNA', 'tolerability', 'EGFR mutations', 'survival']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C4324656', 'cui_str': 'Non-squamous non-small cell lung cancer'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}]","[{'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",389.0,0.196023,Mb was significantly associated with improved RFS with Pem/Cis vs Vnr/Cis (not reached vs 52.5 months; hazard ratio (HR) 0.477).,"[{'ForeName': 'Kazuko', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Ohira', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Thoracic Surgery, National Hospital Organization, Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Aoki', 'Affiliation': 'Department of Chest Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Thoracic Surgery, Kyushu Medical Center, Clinical Research Institute, National Hospital Organization, Fukuoka, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Okumura', 'Affiliation': 'Department of Thoracic Surgery, Kurashiki Central Hospital, Kurashiki, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Akimasa', 'Initials': 'A', 'LastName': 'Sekine', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Haruki', 'Affiliation': 'Division of General Thoracic Surgery, Department of Surgery, Faculty of Medicine, Tottori University, Tottori, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of General Thoracic Surgery, Breast and Endocrinological Surgery, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Akamatsu', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Respiratory Medicine, Kumamoto University Hospital, Kumamoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Okabe', 'Affiliation': 'Department of Thoracic Surgery, National Hospital Organization Yamaguchi Ube Medical Center, Yamaguchi, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kazuto', 'Initials': 'K', 'LastName': 'Nishio', 'Affiliation': 'Department of Genome Biology, Kindai University Faculty of Medicine, Osaka-sayama, Japan.'}]",Cancer science,['10.1111/cas.14730']
1519,33188584,D-chiro-inositol as a treatment in plaque psoriasis: A randomized placebo-controlled clinical trial.,"Cyclitols are widely available natural sugars which do not exert toxic effects. Their anti-inflammatory and antioxidant properties may be used in the treatment of psoriasis. The aim of this placebo-controlled, double-blind study was to evaluate the clinical effects of D-chiro-inositol (DCI) in mild plaque psoriasis (46 psoriatic patients and 10 healthy volunteers). Three stable psoriatic plaques were selected for evaluation in every patient. Different samples were applied on each lesion twice a day: vehiculum without an active agent, containing 1% DCI and 0.25% DCI. The lesions were assessed using the PSI, VAS scale, and the objective measurement of hydration, transepidermal water loss (TEWL), elasticity, and thickness (DermaLab Combo) at 0, 3, and 6 weeks. PSI and VAS were improved in all groups without significant statistical differences. 1% DCI sample presented the highest statistically significant increase in the hydration of 50%, but it was still significantly lower than in healthy controls. TEWL increased for 1% DCI, which was a statistically significant difference compared to 0.25% DCI and still higher than in controls. An improvement in elasticity was observed in all lesions-it was statistically significant for 1% DCI. The thickness of the lesion decreased for 1% DCI, but the change was not statistically significant. Subepidermal low-echogenic band showed a decreasing tendency in all groups, but it was not statistically significant. Favorable 1% DCI sample results indicate that it may be used as an adjuvant to the local treatment of psoriasis.",2020,"Subepidermal low-echogenic band showed a decreasing tendency in all groups, but it was not statistically significant.","['mild plaque psoriasis (46 psoriatic patients and 10 healthy volunteers', 'plaque psoriasis']","['placebo', 'D-chiro-inositol (DCI', 'D-chiro-inositol']","['TEWL', 'PSI, VAS scale, and the objective measurement of hydration, TEWL, elasticity and thickness (DermaLab Combo', 'elasticity', 'thickness of the lesion', 'PSI and VAS']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}]","[{'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",46.0,0.0385023,"Subepidermal low-echogenic band showed a decreasing tendency in all groups, but it was not statistically significant.","[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Owczarczyk-Saczonek', 'Affiliation': 'Department of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, The University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Czerwińska', 'Affiliation': 'Department of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, The University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wygonowska', 'Affiliation': 'Department of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, The University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kasprowicz-Furmańczyk', 'Affiliation': 'Department of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, The University of Warmia and Mazury, Olsztyn, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Placek', 'Affiliation': 'Department of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, The University of Warmia and Mazury, Olsztyn, Poland.'}]",Dermatologic therapy,['10.1111/dth.14538']
1520,33186729,Intranasal Fentanyl Versus Placebo for Treatment of Episodic Breathlessness in Hospice Patients With Advanced Nonmalignant Diseases.,"CONTEXT
Episodic breathlessness is a distressing and difficult to treat symptom because of its short duration. Fast actioned intranasal fentanyl (INF) is potentially more suitable than oral opioids.
OBJECTIVES
To examine the feasibility, preliminary efficacy, and safety of INF for the treatment of episodic breathlessness from advanced nonmalignant conditions in hospice patients.
METHODS
Phase IIB, double-blind, randomized controlled, multisite, INF citrate solution vs. placebo crossover feasibility study. Opioid-tolerant patients were to treat six episodes of breathlessness using INF spray. The primary outcome was change in the Visual Analogue Scale for dyspnea (VAS-D) score from baseline to 15 minutes after study drug's administration (VAS-D 15 ). Other outcomes were to collect demographic data and determine the use of rescue medications, safety, and feasibility of the study design.
RESULTS
Twenty-one of 49 eligible patients were enrolled, and 19 (90%) patients completed the study. The mean difference in VAS-D 15 between fentanyl and placebo was -3.37 mm (95% CI = -10.35 to 3.61 mm; P = 0.337). There was no statistically significant or clinically meaningful difference between INF and placebo in relieving the sensation of discomfort in episodic breathlessness. No significant drug-related adverse event or detrimental effect on vital signs was observed.
CONCLUSION
We found no difference between INF and placebo in relieving episodic breathlessness in nonmalignant conditions. INF was well tolerated, and the study design proved to be feasible in hospice patients with advanced diseases. Future study using higher concentration of fentanyl solution may be warranted.",2020,There was no statistically significant or clinically meaningful difference between INF and placebo in relieving the sensation of discomfort in episodic breathlessness.,"['episodic breathlessness from advanced non-malignant conditions in hospice patients', 'hospice patients with advanced diseases', 'Hospice Patients with Advanced Non-malignant Diseases', '21 out of 49 eligible patients were enrolled and 19 (90%) patients completed the study']","['intranasal fentanyl citrate solution versus placebo', 'Intranasal Fentanyl', 'placebo', 'intranasal fentanyl spray', 'Placebo', 'intranasal fentanyl (INF']","['episodic breathlessness', 'sensation of discomfort in episodic breathlessness', 'Episodic Breathlessness', 'Visual Analogue Scale for dyspnoea (VAS-D) score', 'vital signs', 'Episodic breathlessness', 'VAS-D15']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0546864', 'cui_str': 'Fentanyl citrate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",49.0,0.360782,There was no statistically significant or clinically meaningful difference between INF and placebo in relieving the sensation of discomfort in episodic breathlessness.,"[{'ForeName': 'Salina', 'Initials': 'S', 'LastName': 'Iupati', 'Affiliation': 'Te Omanga Hospice, Hutt City, New Zealand. Electronic address: salina.iupati@teomanga.org.nz.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bridge', 'Affiliation': 'Te Omanga Hospice, Hutt City, New Zealand.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Allan', 'Affiliation': 'Arohanui Hospice, Palmerston North, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Hewitt', 'Affiliation': 'Arohanui Hospice, Palmerston North, New Zealand.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.11.003']
1521,33187076,Effectiveness of a Group-Based Progressive Strength Training in Primary Care to Improve the Recurrence of Low Back Pain Exacerbations and Function: A Randomised Trial.,"Low back pain (LBP) is the leading cause of disability and one of the most common reasons for physician visits in primary care, with a 33% rate of recurrence during the first year. However, the most optimal exercise program in this context remains unknown. The objective was to evaluate the effectiveness of a group-based progressive strength training program in non-specific chronic LBP (CLBP) patients in primary care on pain recurrence and physical function. Eighty-five patients with non-specific CLBP were separated into two groups (Intervention group: completed a progressive strength training program 3 days per week for 8 weeks; Control group: received the usual care). The intervention group showed a recurrence rate of 8.3%, while the control group had a recurrence rate of 33.3% and a shorter time until the first recurrent episode. The intervention group showed increased lumbar extensor strength, left-hand handgrip strength, and reduced the number of pain sites compared with the control group. Results also showed greater odds for reducing LBP intensity and disability in the intervention group. In conclusion, a group-based progressive strength training program is a more effective and efficient alternative than Back-School programs and can easily be carried out in the primary health care context.",2020,"The intervention group showed a recurrence rate of 8.3%, while the control group had a recurrence rate of 33.3% and a shorter time until the first recurrent episode.","['Eighty-five patients with non-specific CLBP', 'non-specific chronic LBP (CLBP) patients in primary care on pain recurrence and physical function']","['Group-Based Progressive Strength Training', 'progressive strength training program', 'group-based progressive strength training program']","['LBP intensity and disability', 'Recurrence of Low Back Pain Exacerbations and Function', 'lumbar extensor strength, left-hand handgrip strength', 'recurrence rate', 'number of pain sites']","[{'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",85.0,0.0246677,"The intervention group showed a recurrence rate of 8.3%, while the control group had a recurrence rate of 33.3% and a shorter time until the first recurrent episode.","[{'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Calatayud', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Benjamín', 'Initials': 'B', 'LastName': 'Guzmán-González', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago 8380419, Chile.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Cruz-Montecinos', 'Affiliation': 'Laboratory of Clinical Biomechanics, Department of Physical Therapy, Faculty of Medicine, University of Chile, Santiago 8380419, Chile.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Morell', 'Affiliation': 'Primary Care Health Department Valencia Arnau-Llíria, 46015 Valencia, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Roldán', 'Affiliation': 'Primary Care Health Department Valencia Arnau-Llíria, 46015 Valencia, Spain.'}, {'ForeName': 'Yasmín', 'Initials': 'Y', 'LastName': 'Ezzatvar', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Casaña', 'Affiliation': 'Exercise Intervention for Health Research Group (EXINH-RG), Department of Physiotherapy, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228326']
1522,33187084,Effects of a Community-Based Pilot Intervention on Home Food Availability among U.S. Households.,"The purpose of this study was to assess the effects of a pilot community-based behavioral intervention on the home food environment in U.S. households. Parents (21 females, 2 males; age = 36 ± 5.5 years; 78% Hispanic) of elementary school-aged children attended a 10-week dietary improvement behavioral intervention targeting an increase in fruit and vegetable consumption and a reduction in sugar intake. Home food availability of fruit, vegetables, and sugar-laden foods and beverages were assessed before and after the intervention using a modified version of the Home Food Inventory. Relative to baseline, the intervention resulted in significant increases in fruit availability (7.7 ± 3.2 items vs. 9.4 ± 3.1 items; p = 0.004) and low sugar cereal (2.3 ± 1.4 types vs. 2.7 ± 1.4 types; p = 0.033). There was a significant reduction in sugar-sweetened beverage availability (3.2 ± 1.9 types vs. 1.7 ± 1.3 types; p = 0.004). There was a significant increase in the number of households with accessible ready-to-eat vegetables and fruit, and a significant reduction in available prepared desserts, and candy ( p < 0.01). There were no significant changes in the availability of vegetables and sugar-laden cereals. The current intervention resulted in positive changes in the home food environment. Further research to confirm these results in a randomized controlled trial is warranted.",2020,"There was a significant increase in the number of households with accessible ready-to-eat vegetables and fruit, and a significant reduction in available prepared desserts, and candy ( p < 0.01).","['Parents (21 females, 2 males; age = 36 ± 5.5 years; 78% Hispanic) of elementary school-aged children attended a', 'Home Food Availability among U.S. Households', 'U.S. households']","['Community-Based Pilot Intervention', '10-week dietary improvement behavioral intervention targeting an increase in fruit and vegetable consumption and a reduction in sugar intake', 'pilot community-based behavioral intervention']","['availability of vegetables and sugar-laden cereals', 'sugar-sweetened beverage availability', 'Home food availability of fruit, vegetables, and sugar-laden foods and beverages', 'fruit availability', 'number of households with accessible ready-to-eat vegetables and fruit']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}]","[{'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]",,0.0324245,"There was a significant increase in the number of households with accessible ready-to-eat vegetables and fruit, and a significant reduction in available prepared desserts, and candy ( p < 0.01).","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Cassinat', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Bruening', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Noe C', 'Initials': 'NC', 'LastName': 'Crespo', 'Affiliation': 'School of Public Health, San Diego State University, 9245 Sky Park Ct. Suite 224, San Diego, CA 92123, USA.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Gutiérrez', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Chavez', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Ray', 'Affiliation': 'City of Phoenix, Parks and Recreation Department, 212 E. Alta Vista Rd., Phoenix, AZ 85402, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Vega-López', 'Affiliation': 'College of Health Solutions, Arizona State University, 550 North 3rd Street, Phoenix, AZ 85004, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17228327']
1523,33187089,Resveratrol Improves Heart Function by Moderating Inflammatory Processes in Patients with Systolic Heart Failure.,"The effects of resveratrol (RES) in heart failure have already been evaluated in animal models; however, in human clinical trials, they have not been confirmed yet. The aim of this study was to assess the effects of resveratrol treatment in systolic heart failure patients (heart failure with reduced ejection fraction or HFrEF). In this human clinical trial, 60 outpatients with NYHA (New York Heart Association) class II-III HFrEF were enrolled and randomized into two groups: receiving either 100-mg resveratrol daily or placebo for three months. At the beginning and at the end of the study echocardiography, a six-minute walk test, spirometry, quality of life questionnaire, lab test and RNA profile analysis were performed. The systolic and diastolic left ventricular function, as well as the global longitudinal strain, were improved significantly in the resveratrol-treated group (RES). Exercise capacity, ventilation parameters and quality of life also improved significantly in the RES group. In parallel, the cardiac biomarker levels (N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and galectin-3) decreased in the treated group. The level of inflammatory cytokines decreased significantly after RES supplementation, as a consequence of the decreased expression level of leucocyte electron transport chain proteins. The main findings of our trial are that RES treatment added to the standard heart failure therapy improved heart function and the clinical condition by moderating the inflammatory processes in patients with HFrEF.",2020,"The systolic and diastolic left ventricular function, as well as the global longitudinal strain, were improved significantly in the resveratrol-treated group (RES).","['Patients with Systolic Heart Failure', 'systolic heart failure patients (heart failure with reduced ejection fraction or HFrEF', 'patients with HFrEF', '60 outpatients with NYHA (New York Heart Association', 'class II-III HFrEF']","['resveratrol treatment', '100-mg resveratrol daily or placebo', 'resveratrol (RES']","['heart function', 'Exercise capacity, ventilation parameters and quality of life', 'cardiac biomarker levels (N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and galectin-3', 'systolic and diastolic left ventricular function', 'spirometry, quality of life questionnaire, lab test and RNA profile analysis', 'level of inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0301817', 'cui_str': 'Prohormone'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0245382', 'cui_str': 'Galectin-3'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",60.0,0.0463392,"The systolic and diastolic left ventricular function, as well as the global longitudinal strain, were improved significantly in the resveratrol-treated group (RES).","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Deres', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Orsolya', 'Initials': 'O', 'LastName': 'Horvath', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Krisztian', 'Initials': 'K', 'LastName': 'Eros', 'Affiliation': 'Szentágothai Research Centre, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Sandor', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Szentágothai Research Centre, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Szilvia', 'Initials': 'S', 'LastName': 'Soos', 'Affiliation': 'Division of Pulmonology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Marton', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Sumegi', 'Affiliation': 'Szentágothai Research Centre, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Kalman', 'Initials': 'K', 'LastName': 'Toth', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Habon', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Halmosi', 'Affiliation': 'Division of Cardiology, 1st Department of Medicine, Medical School, University of Pecs, 7602 Pecs, Hungary.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9111108']
1524,33212138,Thirst perception exacerbates objective mental fatigue.,"Thirst is represented within the anterior cingulate and insular cortices, and may share some common neuroanatomical structures that are implicated with the regulation of mental fatigue. This novel study investigated whether thirst might modulate the subjective, behavioural, or neurophysiological representations of mental fatigue. In a crossover design, thirst was monitored in 15 males during 60 min of cycling in normothermic conditions. Participants either consumed water to the dictates of their thirst (sated), or fluid was withheld and replaced with periodic salt water mouth rinses (thirst). Following either satiety or thirst, a 60 min modified Stroop task was completed to evoke mental fatigue. Prefrontal cortex (PFC) haemodynamics were monitored throughout the prolonged task, and subjective perceptions of fatigue were reported through a visual analogue scale. Behavioural performance was quantified as the total number of Stroop task iterations completed in the mentally fatiguing task, and by collating response time and accuracy into the inverse efficiency score (IES) for each 5 min interval throughout the task. During thirst, fewer iterations were completed and poorer IES performance was evident toward the latter portion of the mentally fatiguing task. Compensatory elevations in PFC oxyhaemoglobin were produced in each condition, however, differed temporally, and were premature during thirst. A diminished capacity to sustain cognitive performance is likely the product of an inability to preserve the distribution of resources within the prefrontal cortex, due to heightened activation about thirst regulatory centres. These data provide novel insight into the relationship between thirst and mental fatigue, and suggest that drinking to the dictates of thirst may be a pertinent strategy to sustain prolonged cognitive performance.",2020,"Compensatory elevations in PFC oxyhaemoglobin were produced in each condition, however, differed temporally, and were premature during thirst.",['15 males during 60 mins of cycling in normothermic conditions'],[],"['total number of Stroop task iterations', 'Behavioural performance', 'IES performance', 'Thirst perception exacerbates objective mental fatigue', 'subjective, behavioural, or neurophysiological representations of mental fatigue', 'Prefrontal cortex (PFC) haemodynamics']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0015676', 'cui_str': 'Mental fatigue'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",,0.0288152,"Compensatory elevations in PFC oxyhaemoglobin were produced in each condition, however, differed temporally, and were premature during thirst.","[{'ForeName': 'Stephen P J', 'Initials': 'SPJ', 'LastName': 'Goodman', 'Affiliation': 'School of Exercise Science, Sport & Health, Charles Sturt University, Bathurst, Australia; School of Science and Technology, University of New England, Armidale, Australia. Electronic address: stephen.goodman@une.edu.au.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Marino', 'Affiliation': 'School of Exercise Science, Sport & Health, Charles Sturt University, Bathurst, Australia. Electronic address: fmarino@csu.edu.au.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107686']
1525,33212239,The Impact of Patient Self-Monitoring Via Electronic Medication Monitor and Mobile App Plus Remote Clinician Feedback on Adherence to Inhaled Corticosteroids: A Randomized Controlled Trial.,"BACKGROUND
Poor adherence to inhaled corticosteroids (ICSs) and overuse of short-acting beta 2 -agonists (SABAs) are associated with increased asthma morbidity.
OBJECTIVE
To assess whether patient self-monitoring via electronic medication monitoring and smartphone application plus remote clinician feedback influences ICS and SABA use.
METHODS
Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study. Inhalers were fitted with electronic medication monitoring to track real-time usage. After a 14-day baseline, participants were randomly assigned to the treatment group where they received reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback. Linear mixed models compared the baseline percentage of SABA-free days and ICS adherence to the last 14 study days.
RESULTS
Participants (n = 100) had a mean age of 48.5 years, 80% were female, 68% white, and 80% privately insured. The percentage of SABA-free days increased significantly in the treatment group (19%; 95% CI, 12 to 26; P < .01) and nonsignificantly in the control group (6%, 95% CI, -3 to 16; P = .18), representing a 13% (95% CI, 1-26; P = .04) difference. ICS adherence changed minimally in the treatment group (-2%; 95% CI, -7 to 3; P = .40), but decreased significantly (-17%; 95% CI, -26 to -8; P < .01) in the control group, representing a 15% (95% CI, 4 to 25; P < .01) difference.
CONCLUSIONS
Patient self-monitoring via a digital platform plus remote clinician feedback maintained high baseline ICS adherence and decreased SABA use.",2020,"ICS adherence changed minimally in the treatment group (-2%, 95% CI: -7, 3; P = 0.40), but decreased significantly (-17%, 95% CI: -26, -8; P < 0.01) in the control group, representing a 15% (95% CI: 4, 25; P < 0.01) difference.
","['Adults with uncontrolled asthma and prescribed ICS and SABA were enrolled in this 14-week study', 'Participants (n=100) had a mean age of 48.5 years, 80% were female, 68% Caucasian and 80% privately insured']","['corticosteroids', 'patient self-monitoring via electronic medication monitor and mobile app plus remote clinician feedback', 'reminders and feedback on ICS and SABA use via a smartphone application and clinician phone calls, or control group without feedback', 'patient self-monitoring via electronic medication monitoring (EMM) and smartphone application plus remote clinician feedback', 'inhaled corticosteroids (ICS']","['percent of SABA-free days', 'ICS adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.251684,"ICS adherence changed minimally in the treatment group (-2%, 95% CI: -7, 3; P = 0.40), but decreased significantly (-17%, 95% CI: -26, -8; P < 0.01) in the control group, representing a 15% (95% CI: 4, 25; P < 0.01) difference.
","[{'ForeName': 'Giselle S', 'Initials': 'GS', 'LastName': 'Mosnaim', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University HealthSystem, Evanston, Ill. Electronic address: Gmosnaim@northshore.org.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stempel', 'Affiliation': 'Propeller Health, an Affiliate of ResMed, San Francisco, Calif.'}, {'ForeName': 'Candy', 'Initials': 'C', 'LastName': 'Gonzalez', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Adams', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'BenIsrael-Olive', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care, Department of Medicine, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Gondalia', 'Affiliation': 'ResMed, San Francisco, Calif.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Kaye', 'Affiliation': 'ResMed, San Francisco, Calif.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Shalowitz', 'Affiliation': 'Research Institute, NorthShore University HealthSystem, Evanston, Ill.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, Section of Allergy and Immunology and Pulmonary and Sleep Medicine, University of Colorado School of Medicine and the Breathing Institute, Children's Hospital Colorado, Aurora, Colo.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.064']
1526,33212337,Does body appreciation or satisfaction buffer against idealised functionality-focused images of models?,"Research suggests that greater levels of body appreciation and body satisfaction may protect women from negative outcomes when viewing media images of the thin-ideal. In this study, we compared the effectiveness of body appreciation and body satisfaction in ameliorating negative effects from viewing images of the traditional thin-ideal and the newer functional-ideal (i.e., models presented in active stances with a focus on the function of their body). A sample of 122 women (M age = 24.43 years) from a regional university and the general community was recruited to complete an online study. Participants were randomly allocated to view images of models presented in either an active or posed stance, or images of scenery. Participants completed pre- and post-test measures of appearance and functionality satisfaction, as well as trait measures of body appreciation and satisfaction. Results showed that women had poorer outcomes after viewing the active but not the posed or scenery images. Neither body appreciation nor body satisfaction moderated effects. Active, functional images may be particularly insidious and further research is needed to identify effective protective strategies.",2020,Neither body appreciation nor body satisfaction moderated effects.,['122 women (M age = 24.43 years) from a regional university and the general community was recruited to complete an online study'],[],"['appearance and functionality satisfaction, as well as trait measures of body appreciation and satisfaction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",122.0,0.0320112,Neither body appreciation nor body satisfaction moderated effects.,"[{'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Mulgrew', 'Affiliation': 'University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, Queensland 4558, Australia. Electronic address: kmulgrew@usc.edu.au.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Findlay', 'Affiliation': 'University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, Queensland 4558, Australia.'}, {'ForeName': 'Ben R', 'Initials': 'BR', 'LastName': 'Lane', 'Affiliation': 'University of the Sunshine Coast, Locked Bag 4, Maroochydore DC, Queensland 4558, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Halliwell', 'Affiliation': 'Centre for Appearance Research, University of the West of England, UK.'}]",Body image,['10.1016/j.bodyim.2020.09.007']
1527,33212355,Effectiveness of the fall prevention intervention in older adults with arterial hypertension: randomized clinical trial.,"OBJECTIVE
To evaluate the effectiveness of the nursing intervention Fall Prevention in reducing falls in older adults with arterial hypertension.
METHODS
Pilot clinical trial, with 118 participants with arterial hypertension from a city in the Northeast of Brazil. Participants were allocated by simple randomization into two groups: intervention (n = 58) and control (n = 60). The intervention was carried out at the participants' homes and consisted of guidelines for modifying environmental and behavioral risk factors for falls. A protocol with nursing activities associated with the Fall Prevention intervention proposed in the Nursing Interventions Classification (NIC) taxonomy was used. The outcome was the self-reported occurrence of falls.
RESULTS
There was a significant difference between the groups in the frequency of self-reported falls (p=0.38) with fewer falls occurring in the intervention group. Sixteen participants fell, of which 5.1% attributed the fall to difficulty walking, 6.8% fell in the living room, 3.4% had a sprain, and 6.8% reported to be afraid to fall again.
CONCLUSION
The nursing intervention Fall Prevention was effective in reducing the occurrence of falls in older adults with arterial hypertension. These findings contribute to the advancement of clinical protocols for the prevention of falls in older adults, as the educational intervention investigated is applicable to different sociodemographic and cultural scenarios.",2020,There was a significant difference between the groups in the frequency of self-reported falls (p=0.38) with fewer falls occurring in the intervention group.,"['older adults with arterial hypertension', 'older adults', '118 participants with arterial hypertension from a city in the Northeast of Brazil']","['fall prevention intervention', 'nursing intervention Fall Prevention', 'nursing intervention']","['self-reported occurrence of falls', 'frequency of self-reported falls']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",118.0,0.0225239,There was a significant difference between the groups in the frequency of self-reported falls (p=0.38) with fewer falls occurring in the intervention group.,"[{'ForeName': 'Francisca Valuzia Guedes', 'Initials': 'FVG', 'LastName': 'Guerra', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: valuziaguedesguerra@gmail.com.'}, {'ForeName': 'Rafaella Pessoa', 'Initials': 'RP', 'LastName': 'Moreira', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: rafaellapessoa@unilab.edu.br.'}, {'ForeName': 'Glauciano', 'Initials': 'G', 'LastName': 'de Oliveira Ferreira', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: glaucianobr86@gmail.com.'}, {'ForeName': 'Janiel Ferreira', 'Initials': 'JF', 'LastName': 'Felício', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: janielferreirafelicio@gmail.com.'}, {'ForeName': 'Tahissa Frota', 'Initials': 'TF', 'LastName': 'Cavalcante', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: tahissa@unilab.edu.br.'}, {'ForeName': 'Thelma Leite', 'Initials': 'TL', 'LastName': 'de Araujo', 'Affiliation': 'Nursing Departament, Federal University of Ceará, 1115 Alexandre Baraúna St., 60430-160, Fortaleza, CE, Brazil. Electronic address: thelmaaraujo2012@gmail.com.'}, {'ForeName': 'Marcio Flavio Moura', 'Initials': 'MFM', 'LastName': 'de Araujo', 'Affiliation': 'Health Sciences Institute, University for International Integration of the Afro-Brazilian Lusophony, s/n José Franco de Oliveira St., 62.790-970, Redenção, CE, Brazil. Electronic address: oicam29@gmail.com.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.11.002']
1528,33212360,Efficacy of a decision support intervention for reducing decisional conflict in patients with elevated serum prostate-specific antigen: A randomized controlled trial.,"PURPOSE
The study purpose is to test the efficacy of a decision support intervention for reducing decisional conflict, increasing prostate biopsy knowledge, and enhancing decision self-efficacy in patients with elevated serum prostate-specific antigen.
METHOD
The study is based on a randomized pre-post test design. A convenience sample of men with elevated prostate-specific antigen was recruited and 1:1 randomized to the intervention and control groups. The intervention group received the decision support intervention and the control group received health education. Data were collected at the baseline and post-test by using self-reported questionnaires, including the Prostate Biopsy Knowledge Scale, the Decision Self-Efficacy Scale, the Decisional Conflict Scale, and questions regarding the prostate biopsy decision (post-test only). Data on prostate-specific antigen levels were collected from the patients' medical records.
RESULTS
A total of 110 patients participated in the study. At baseline, the intervention group had significantly higher knowledge scores than the control group. The analysis of the covariance model with the baseline score as a covariate was used to analyze the intervention effect. After controlling for the baseline scores, the mean differences (95% CI) between the two groups were 11.75 (11.17-12.32), 76.45 (72.52-80.37), and -23.53 (-26.31-20.20) for knowledge, decision self-efficacy, and decisional conflict, respectively. The between-group difference in willingness to accept prostate biopsy at the post-test was not statistically significant (χ 2 = 1.704).
CONCLUSIONS
The decision support intervention significantly reduced patients' decisional conflict while improving their knowledge and self-efficacy. However, the intervention did not affect patients' biopsy decision.",2020,"At baseline, the intervention group had significantly higher knowledge scores than the control group.","['men with elevated prostate-specific antigen', ""patients' medical records"", 'patients with elevated serum prostate-specific antigen', '110 patients participated in the study']","['decision support intervention', 'decision support intervention and the control group received health education']","[""patients' decisional conflict"", 'Prostate Biopsy Knowledge Scale, the Decision Self-Efficacy Scale, the Decisional Conflict Scale, and questions regarding the prostate biopsy decision', 'willingness to accept prostate biopsy', 'knowledge and self-efficacy', 'knowledge, decision self-efficacy, and decisional conflict', 'knowledge scores', 'decisional conflict']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0194804', 'cui_str': 'Biopsy of prostate'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",110.0,0.0369011,"At baseline, the intervention group had significantly higher knowledge scores than the control group.","[{'ForeName': 'Tsae-Jyy', 'Initials': 'TJ', 'LastName': 'Wang', 'Affiliation': ', School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan. Electronic address: tsaejyy@ntunhs.edu.tw.'}, {'ForeName': 'Pei-Pei', 'Initials': 'PP', 'LastName': 'Chiu', 'Affiliation': 'Department of Nursing, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: kyoto.sakura0106@gmail.com.'}, {'ForeName': 'Kuang-Kuo', 'Initials': 'KK', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Cheng Hsin General Hospital, Taipei, Taiwan. Electronic address: kkchen@vghtpe.gov.tw.'}, {'ForeName': 'Lun-Ping', 'Initials': 'LP', 'LastName': 'Hung', 'Affiliation': 'Department of Information Management, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan. Electronic address: lunping@ntunhs.edu.tw.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101865']
1529,33213015,The Impact of Overnight Orthokeratology on Accommodative Response in Myopic Subjects.,"This study aimed to evaluate the effects of two months of orthokeratology (OK) treatment in the accommodative response of young adult myopes. Twenty eyes (21.8 ± 1.8 years) were fitted with the Paragon CRT ® 100 LENS to treat myopia between -1.00 and -2.00 D. Low- and high-contrast visual acuity (LCDVA and HCDVA), central objective refraction, light disturbance (LD), and objective accommodative response (using the Grand Seiko WAM-5500 open-field autorefractometer coupled with a Badal system) were measured at baseline (BL) before lens wear and after 1, 15, 30, and 60 nights of OK. Refractive error correction was achieved during the first fifty days of OK lens wear, with minimal changes afterwards. LD analysis showed a transient increase followed by a reduction to baseline levels over the first 30 nights of treatment. The accommodative response was lower than expected for all target vergences in all visits (BL: 0.61 D at 1.00 D to 0.96 D at 5.00 D; 60 N: 0.36 D at 1.00 D to 0.79 D at 5.00 D). On average, the accommodative lag decreases over time with OK lens wear. However, these differences were not statistically significant ( p > 0.050, repeated-measures ANOVA and Friedman test). This shows that overnight OK treatment does not affect objectively measured the accommodative response of young, low myopic eyes after two months of treatment stabilization.",2020,"However, these differences were not statistically significant ( p > 0.050, repeated-measures ANOVA and Friedman test).","['Twenty eyes (21.8 ± 1.8 years', 'Myopic Subjects', 'young adult myopes']","['orthokeratology (OK', 'Overnight Orthokeratology']","['Refractive error correction', 'accommodative response', 'visual acuity (LCDVA and HCDVA), central objective refraction, light disturbance (LD), and objective accommodative response']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1827224', 'cui_str': 'Accommodative response'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301317', 'cui_str': 'Objective refraction'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0237147,"However, these differences were not statistically significant ( p > 0.050, repeated-measures ANOVA and Friedman test).","[{'ForeName': 'Ana F', 'Initials': 'AF', 'LastName': 'Pereira-da-Mota', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Costa', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Amorim-de-Sousa', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'González-Méijome', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Queirós', 'Affiliation': 'Clinical and Experimental Optometry Research Lab (CEORLab), Center of Physics, School of Science, University of Minho, Gualtar, 4710-057 Braga, Portugal.'}]",Journal of clinical medicine,['10.3390/jcm9113687']
1530,33213070,Usefulness of Antioxidants as Adjuvant Therapy for Septic Shock: A Randomized Clinical Trial.,"Background and objectives: Oxidative stress (OS) participates in the pathophysiology of septic shock, which leads to multiple organ failure (MOF), ischemia-reperfusion injury, and acute respiratory distress syndrome. Therefore, antioxidants have been proposed as therapy. Here, we evaluated the effect of antioxidant treatments in patients with septic shock with MOF and determined levels OS before and after treatment. This study was a randomized, controlled, triple-masked, and with parallel assignment clinical trial with a control group without treatment. Materials and Methods: It included 97 patients of either sex with septic shock. 5 treatments were used each in an independent group of 18 patients. Group 1 received vitamin C (Vit C), group 2 vitamin E (Vit E), group 3 n-acetylcysteine (NAC), group 4 melatonin (MT), and group 5 served as control. All antioxidants were administered orally or through a nasogastric tube for five days as an adjuvant to the standard therapy. Results: The results showed that all patients presented MOF due to sepsis upon admission and that the treatment decreased it ( p = 0.007). The antioxidant treatment with NAC increased the total antioxidant capacity ( p < 0.05). The patients that received Vit C had decreased levels of the nitrate and nitrite ratio ( p < 0.01) and C-reactive protein levels ( p = 0.04). Procalcitonin levels were reduced by Vit E ( p = 0.04), NAC ( p = 0.001), and MT ( p = 0.04). Lipid-peroxidation was reduced in patients that received MT ( p = 0.04). Conclusions: In conclusion, antioxidant therapy associated with standard therapy reduces MOF, OS, and inflammation in patients with septic shock.",2020,"Procalcitonin levels were reduced by Vit E ( p = 0.04), NAC ( p = 0.001), and MT ( p = 0.04).","['97 patients of either sex with septic shock', 'patients with septic shock with MOF and determined levels OS before and after treatment', 'patients with septic shock', 'Septic Shock']","['antioxidant therapy', 'antioxidant', 'Vit C', 'vitamin C (Vit C), group 2 vitamin E (Vit E), group 3 n-acetylcysteine (NAC), group 4 melatonin (MT), and group 5 served as control', 'Antioxidants']","['Lipid-peroxidation', 'total antioxidant capacity', 'nitrate and nitrite ratio', 'C-reactive protein levels', 'MOF, OS, and inflammation', 'Procalcitonin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C1879713', 'cui_str': 'Antioxidant therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}]",97.0,0.462944,"Procalcitonin levels were reduced by Vit E ( p = 0.04), NAC ( p = 0.001), and MT ( p = 0.04).","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Aisa-Alvarez', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Soto', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Guarner-Lans', 'Affiliation': 'Physiology Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Camarena-Alejo', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Juvenal', 'Initials': 'J', 'LastName': 'Franco-Granillo', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Enrique A', 'Initials': 'EA', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Critical Care Department, American British Cowdray (ABC) Medical Center, I.A.P. ABC Sur 136 No. 116 Col. las Américas, Mexico City 01120, Mexico.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gamboa Ávila', 'Affiliation': 'Physiology Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}, {'ForeName': 'Linaloe', 'Initials': 'L', 'LastName': 'Manzano Pech', 'Affiliation': 'Cardiovascular Biomedicine Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Pérez-Torres', 'Affiliation': 'Cardiovascular Biomedicine Department Instituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Sección XVI, Tlalpan, Mexico City 14080, Mexico.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110619']
1531,33214190,"Efficacy, safety and cost-effectiveness comparison between U-100 human regular insulin and rapid acting insulin when delivered by V-Go wearable insulin delivery device in type 2 diabetes.","INTRODUCTION
We compared the efficacy and safety of human regular insulin (HRI) versus rapid-acting insulin (RAI) in a type 2 diabetes population already using the V-Go insulin delivery device.
RESEARCH DESIGN AND METHODS
This was a 14-week, multicenter, randomized, open-label, parallel-group, phase IV, non-inferiority study. Patients ≥21years of age, with inadequately controlled type 2 diabetes who were currently using the V-Go insulin delivery system with RAI, with glycated hemoglobin (HbA1c) ≥6.5% (≥48 mmol/L) to ≤12.5% (≤108 mmol/L) were randomized 1:1 to RAI continuation or switch to HRI. The primary outcome was estimated treatment difference (ETD) in HbA1c least-squares mean change from baseline at 14 weeks (prespecified non-inferiority hypothesis with 95% CI upper limit <0.4%). Primary analysis was by per protocol (PP); safety analysis was by intention to treat.
RESULTS
We randomized 136 patients to continued RAI treatment (n=67) or HRI (n=69); 113 patients were included in the PP analysis (RAI, n=54; HRI, n=59). Mean change in HbA1c from baseline to study end was -0.60±1.1% (95% CI -0.90 to -0.29); -6.6±12.0 mmol/mol (95% CI -9.8 to -3.2) with HRI treatment and -0.38±1.3% (95% CI -0.70 to -0.05); -4.2±14.2 mmol/mol (95% CI -7.7 to -0.5) with RAI treatment, with ETD of -0.22% (95% CI -0.67 to 0.22); -2.4 mmol/mol (95% CI -7.3 to 2.4), p=0.007, confirming non-inferiority of HRI to RAI. No between-group differences in changes in total daily insulin doses, number of hypoglycemic values (≤70 mg/dL (≤39 mmol/L) or body weight were observed. No severe hypoglycemic events were reported. Direct pharmacy cost savings (-US$265.85; 95% CI -US$288.60 to -US$243.11; p<0.0001) were observed with HRI treatment.
CONCLUSIONS
Individuals with type 2 diabetes requiring insulin can be treated with V-Go wearable insulin delivery device using HRI, safely and effectively, and potentially at a much lower cost compared with RAI, which can lead to improved access to insulin therapy for these individuals.
TRIAL REGISTRATION NUMBER
NCT03495908.",2020,No severe hypoglycemic events were reported.,"['Individuals with type 2 diabetes requiring', 'type 2 diabetes', 'Patients ≥21years of age, with inadequately controlled type 2 diabetes who were currently using the V-Go insulin delivery system with RAI, with glycated hemoglobin (HbA1c) ≥6.5% (≥48\u2009mmol/L) to ≤12.5% (≤108\u2009mmol/L', '136 patients to continued RAI treatment (n=67) or HRI (n=69); 113 patients were included in the PP analysis (RAI, n=54; HRI, n=59']","['insulin', 'human regular insulin (HRI) versus rapid-acting insulin (RAI', 'U-100 human regular insulin and rapid acting insulin', 'RAI continuation or switch to HRI']","['Direct pharmacy cost savings', 'body weight', 'Mean change in HbA1c', 'Efficacy, safety and cost-effectiveness', 'total daily insulin doses, number of hypoglycemic values', 'severe hypoglycemic events', 'estimated treatment difference (ETD) in HbA1c least-squares mean change']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C0356365', 'cui_str': 'Short-acting insulin'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",136.0,0.274103,No severe hypoglycemic events were reported.,"[{'ForeName': 'Pablo F', 'Initials': 'PF', 'LastName': 'Mora', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, The University of Texas Southwestern Medical Center, Dallas, Texas, USA pf_mora@yahoo.com.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Sutton', 'Affiliation': 'Northeast Florida Endocrine and Diabetes Associates, Jacksonville, Florida, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Gore', 'Affiliation': 'Jones Center for Diabetes and Endocrine Wellness, Macon, Georgia, USA.'}, {'ForeName': 'Bantwal', 'Initials': 'B', 'LastName': 'Baliga', 'Affiliation': 'East Alabama Endocrinology PC, Columbus, Ohio, USA.'}, {'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Goldfaden', 'Affiliation': 'East Coast Institute for Research, LLC, Jacksonville, Florida, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Nikkel', 'Affiliation': 'Zealand Pharma US Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sink Ii', 'Affiliation': 'Zealand Pharma US Inc, Boston, Massachusetts, USA.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Adams-Huet', 'Affiliation': 'Independent Statistician, Coppell, Texas, USA.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2020-001832']
1532,33214331,Randomized Controlled Trial of High-Flow Nasal Cannula in Preterm Infants After Extubation.,"OBJECTIVES
Our aim is to compare the efficacy and safety of high-flow nasal cannula (HFNC) against those of nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive-pressure ventilation (NIPPV) after extubation in preterm infants.
METHODS
This prospective, randomized, noninferiority trial was conducted in 6 tertiary NICUs. Infants born at <34 weeks who needed noninvasive ventilation after extubation were enrolled. We randomly assigned infants to an HFNC group when HFNC was used or to an NCPAP/NIPPV group when NCPAP or NIPPV was used. The primary outcome was treatment failure within 7 days after extubation. We then examined clinical aspects of treatment failure with HFNC use.
RESULTS
In total, 176 and 196 infants were assigned to the HFNC and NCPAP/NIPPV groups, respectively. The HFNC group showed a significantly higher rate of treatment failure than that of the NCPAP/NIPPV group, with treatment failure occurring in 54 infants (31%) compared with 31 infants (16%) in the NCPAP/NIPPV group (risk difference, 14.9 percentage points; 95% confidence interval, 6.2-23.2). Histologic chorioamnionitis ( P = .02), treated patent ductus arteriosus ( P = .001), and corrected gestational age at the start of treatment ( P = .007) were factors independently related to treatment failure with HFNC use.
CONCLUSIONS
We found HFNC revealed a significantly higher rate of treatment failure than NCPAP or NIPPV after extubation in preterm infants. The independent factors associated with treatment failure with HFNC use were histologic chorioamnionitis, treated patent ductus arteriosus, and a younger corrected gestational age at the start of treatment.",2020,"The HFNC group showed a significantly higher rate of treatment failure than that of the NCPAP/NIPPV group, with treatment failure occurring in 54 infants (31%) compared with 31 infants (16%) in the NCPAP/NIPPV group (risk difference, 14.9 percentage points; 95% confidence interval, 6.2-23.2).","['Preterm Infants', 'In total, 176 and 196 infants', 'Infants born at <34 weeks who needed noninvasive ventilation after extubation were enrolled', 'preterm infants']","['HFNC group when HFNC', 'HFNC', 'NCPAP/NIPPV group when NCPAP or NIPPV', 'NCPAP or NIPPV', 'NCPAP/NIPPV', 'High-Flow Nasal Cannula', 'high-flow nasal cannula (HFNC', 'HFNC and NCPAP/NIPPV', 'nasal continuous positive airway pressure (NCPAP) or nasal intermittent positive-pressure ventilation (NIPPV']","['rate of treatment failure', 'efficacy and safety', 'treated patent ductus arteriosus ', 'treatment failure within 7 days after extubation', 'Histologic chorioamnionitis']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}]",196.0,0.233709,"The HFNC group showed a significantly higher rate of treatment failure than that of the NCPAP/NIPPV group, with treatment failure occurring in 54 infants (31%) compared with 31 infants (16%) in the NCPAP/NIPPV group (risk difference, 14.9 percentage points; 95% confidence interval, 6.2-23.2).","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Pediatrics and uchiyama.atsushi@tsc.u-tokai.ac.jp.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Okazaki', 'Affiliation': ""Department of Neonatology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': ""Department of Neonatology, Tokyo Metropolitan Children's Medical Center, Tokyo, Japan.""}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Oka', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center and Saitama Medical University, Saitama, Japan; uchiyama.atsushi@tsc.u-tokai.ac.jp.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Motojima', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center and Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Namba', 'Affiliation': 'Department of Pediatrics, Saitama Medical Center and Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Nagano', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, Nihon University, Tokyo, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, Nihon University, Tokyo, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Kayama', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, Nihon University, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Neonatology, Nagaoka Red Cross Hospital, Niigata, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Soeno', 'Affiliation': 'Department of Neonatology, Nagaoka Red Cross Hospital, Niigata, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Numata', 'Affiliation': 'Department of Neonatology, Nagaoka Red Cross Hospital, Niigata, Japan.'}, {'ForeName': 'Hideyo', 'Initials': 'H', 'LastName': 'Suenaga', 'Affiliation': ""Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Imai', 'Affiliation': ""Department of Neonatal Medicine, Maternal and Perinatal Center, Tokyo Women's Medical University, Tokyo, Japan.""}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Division of Neonatology, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Hideshi', 'Initials': 'H', 'LastName': 'Fujinaga', 'Affiliation': 'Division of Neonatology, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Furuya', 'Affiliation': 'Basic Clinical Science and Public Health, School of Medicine, Tokai University, Kanagawa, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Division of Neonatology, Center for Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatrics,['10.1542/peds.2020-1101']
1533,33215456,Azathioprine for prevention of clinical recurrence in Crohn's disease patients with severe endoscopic recurrence: an IG-IBD randomized double-blind trial.,"OBJECTIVE
The recurrence of Crohn's Disease after ileo-colonic resection is a crucial issue. Severe endoscopic lesions increase the risk of developing early symptoms. Prevention and treatment of post-operative Endoscopic Recurrence (ER) have been studied with conflicting results. We compare effi cacy of azathioprine (AZA) vs. high-dose 5-aminosalicylic acid (5-ASA) in preventing clinical recurrence and treating severe post-operative ER.
PATIENTS AND METHODS
We performed a 1-year multicenter randomized double-blind double-dummy trial. Primary end-points were endoscopic improvement and therapeutic failure (clinical recurrence or drug discontinuation due to lack of efficacy or adverse events) 12 months after randomization. We also performed a post-trial analysis on symptomatic and endoscopic outcomes 10 years after the beginning of the trial, with a median follow-up of 60 months.
RESULTS
Therapeutic failure occurred in 8 patients (17.4%) within 12 months from randomization, with no significant difference between patients treated with 5-ASA (20.8%, 5 patients) and those with AZA (13.6%, 3 patients). Therapeutic failure was due to clinical recurrence in the 5-ASA group and to adverse events in the AZA group. Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group. No serious adverse event was recorded. At the post-trial analysis (median follow-up 60 months), 47.8% (22/46) of patients experienced clinical recurrence: 54.2% (13/24) in the 5-ASA group and 40.9% (9/22) in the AZA group, p=0.546. Patients treated with AZA had lower risk of drug escalation. Clinical recurrence was associated with smoking (p=0.031) and previous surgery (p=0.003).
CONCLUSIONS
Our trial indicates that there was no difference in terms of treatment failure between 5-ASA and AZA in patients with severe ER. The main limit of AZA is its less favorable safety profile.",2020,"Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group.","['patients with severe ER', ""Crohn's disease patients with severe endoscopic recurrence""]","['azathioprine (AZA) vs. high-dose 5-aminosalicylic acid (5-ASA', 'post-operative Endoscopic Recurrence (ER', '5-ASA', 'Azathioprine', 'AZA', '5-ASA and AZA']","['Clinical recurrence', 'lower risk of drug escalation', 'endoscopic improvement and therapeutic failure (clinical recurrence or drug discontinuation due to lack of efficacy or adverse events', 'clinical recurrence', 'Endoscopic improvement', 'Therapeutic failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.725759,"Endoscopic improvement at 12 months was observed in 8 patients, 2 (11.8%) in the 5-ASA group and 6 (30%) in the AZA group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Orlando', 'Affiliation': 'IBD Unit, Villa Sofia-Cervello Hospital, Palermo, Italy. fmocciaro@gmail.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Mocciaro', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ventimiglia', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Renna', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': ''}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Scribano', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Testa', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Aratari', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bossa', 'Affiliation': ''}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Angelucci', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Onali', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cappello', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Giunta', 'Affiliation': ''}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Scimeca', 'Affiliation': ''}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Macaluso', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': ''}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Papi', 'Affiliation': ''}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Annese', 'Affiliation': ''}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Biancone', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kohn', 'Affiliation': ''}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Di Mitri', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cottone', 'Affiliation': ''}]",European review for medical and pharmacological sciences,['10.26355/eurrev_202011_23627']
1534,33215715,Heightened sensitivity to the caregiving environment during adolescence: implications for recovery following early-life adversity.,"BACKGROUND
Adolescence has been proposed to be a period of heightened sensitivity to environmental influence. If true, adolescence may present a window of opportunity for recovery for children exposed to early-life adversity. Recent evidence supports adolescent recalibration of stress response systems following early-life adversity. However, it is unknown whether similar recovery occurs in other domains of functioning in adolescence.
METHODS
We use data from the Bucharest Early Intervention Project - a randomized controlled trial of foster care for children raised in psychosocially depriving institutions - to examine the associations of the caregiving environment with reward processing, executive functioning, and internalizing and externalizing psychopathology at ages 8, 12, and 16 years, and evaluate whether these associations change across development.
RESULTS
Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment. The associations of caregiving with executive function and internalizing and externalizing symptoms varied by age and were strongest at age 16 relative to ages 8 and 12 years. This heightened sensitivity to caregiving in adolescence was observed in both children with and without exposure to early psychosocial neglect.
CONCLUSIONS
Adolescence may be a period of heightened sensitivity to the caregiving environment, at least for some domains of functioning. For children who experience early psychosocial deprivation, this developmental period may be a window of opportunity for recovery of some functions. Albeit correlational, these findings suggest that it may be possible to reverse or remediate some of the lasting effects of early-life adversity with interventions that target caregiving during adolescence.",2020,"Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment.",['varied by age and were strongest at age 16 relative to ages 8 and 12\xa0years'],[],"['reward responsivity and lower levels of internalizing and externalizing symptoms', 'caregiving with executive function and internalizing and externalizing symptoms']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.128357,"Higher quality caregiving in adolescence was associated with greater reward responsivity and lower levels of internalizing and externalizing symptoms, after covarying for the early-life caregiving environment.","[{'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Colich', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Sheridan', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Humphreys', 'Affiliation': 'Department of Psychology and Human Development, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'Department of Applied Psychology and Human Development, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Tibu', 'Affiliation': 'Department of Health and Human Development, Stefan cel Mare University of Suceava, Romania.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Department of Psychiatry, Tulane University School of Medicine, New Orleans, LA, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'Department of Human Development and Quantitative Methodology, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'McLaughlin', 'Affiliation': 'Department of Psychology, Harvard University, Boston, MA, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13347']
1535,33215986,"Risk-based, 6-monthly and 24-monthly dental check-ups for adults: the INTERVAL three-arm RCT.","BACKGROUND
Traditionally, patients are encouraged to attend dental recall appointments at regular 6-month intervals, irrespective of their risk of developing dental disease. Stakeholders lack evidence of the relative effectiveness and cost-effectiveness of different recall strategies and the optimal recall interval for maintenance of oral health.
OBJECTIVES
To test effectiveness and assess the cost-benefit of different dental recall intervals over a 4-year period.
DESIGN
Multicentre, parallel-group, randomised controlled trial with blinded clinical outcome assessment at 4 years and a within-trial cost-benefit analysis. NHS and participant perspective costs were combined with benefits estimated from a general population discrete choice experiment. A two-stratum trial design was used, with participants randomised to the 24-month interval if the recruiting dentist considered them clinically suitable. Participants ineligible for 24-month recall were randomised to a risk-based or 6-month recall interval.
SETTING
UK primary care dental practices.
PARTICIPANTS
Adult, dentate, NHS patients who had visited their dentist in the previous 2 years.
INTERVENTIONS
Participants were randomised to attend for a dental check-up at one of three dental recall intervals: 6-month, risk-based or 24-month recall.
MAIN OUTCOMES
Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit.
RESULTS
A total of 2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible. There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison. For the eligible for 24-month recall stratum: the 24-month ( n = 138) versus 6-month group ( n = 135) had an adjusted mean difference of -0.91 (95% confidence interval -5.02 to 3.20); the risk-based ( n = 143) versus 6-month group had an adjusted mean difference of -0.98 (95% confidence interval -5.05 to 3.09); the 24-month versus risk-based group had an adjusted mean difference of 0.07 (95% confidence interval -3.99 to 4.12). For the overall sample, the risk-based ( n = 749) versus 6-month ( n = 737) adjusted mean difference was 0.78 (95% confidence interval -1.17 to 2.72). There was no evidence of a difference in oral health-related quality of life between intervention arms in any comparison. For the economic evaluation, under framework 1 (cost per quality-adjusted life-year) the results were highly uncertain, and it was not possible to identify the optimal recall strategy. Under framework 2 (net societal benefit), 6-month recalls were the most efficient strategy with a probability of positive net benefit ranging from 78% to 100% across the eligible and combined strata, with findings driven by the high value placed on more frequent recall services in the discrete choice experiment. Under framework 3 (net dental health benefit), 24-month recalls were the most likely strategy to deliver positive net (dental health) benefit among those eligible for 24-month recall, with a probability of positive net benefit ranging from 65% to 99%. For the combined group, the optimal strategy was less clear. Risk-based recalls were more likely to be the most efficient recall strategy in scenarios where the costing perspective was widened to include participant-incurred costs, and in the Scottish subgroup.
LIMITATIONS
Information regarding factors considered by dentists to inform the risk-based interval and the interaction with patients to determine risk and agree the interval were not collected.
CONCLUSIONS
Over a 4-year period, we found no evidence of a difference in oral health for participants allocated to a 6-month or a risk-based recall interval, nor between a 24-month, 6-month or risk-based recall interval for participants eligible for a 24-month recall. However, people greatly value and are willing to pay for frequent dental check-ups; therefore, the most efficient recall strategy depends on the scope of the cost and benefit valuation that decision-makers wish to consider.
FUTURE WORK
Assessment of the impact of risk assessment tools in informing risk-based interval decision-making and techniques for communicating a variable recall interval to patients.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN95933794.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme [project numbers 06/35/05 (Phase I) and 06/35/99 (Phase II)] and will be published in full in Health Technology Assessment ; Vol. 24, No. 60. See the NIHR Journals Library website for further project information.",2020,There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison.,"['Participants ineligible for 24-month recall', 'Adult, dentate, NHS patients who had visited their dentist in the previous 2 years', '2372 participants were recruited from 51 dental practices; 648 participants were eligible for the 24-month recall stratum and 1724 participants were ineligible', 'UK primary care dental practices']",[],"['oral health', 'oral health-related quality of life', 'Clinical - gingival bleeding on probing; patient - oral health-related quality of life; economic - three analysis frameworks: (1) incremental cost per quality-adjusted life-year gained, (2) incremental net (societal) benefit and (3) incremental net (dental health) benefit', 'mean percentage of sites with gingival bleeding']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0376349', 'cui_str': 'Bleeding on probing of gingivae'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}]",2372.0,0.212193,There was no evidence of a significant difference in the mean percentage of sites with gingival bleeding between intervention arms in any comparison.,"[{'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Nigel B', 'Initials': 'NB', 'LastName': 'Pitts', 'Affiliation': ""Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Goulao', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Dwayne', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Ramsay', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Floate', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Hazel J', 'Initials': 'HJ', 'LastName': 'Braid', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Fee', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Fiona S', 'Initials': 'FS', 'LastName': 'Ord', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Helen V', 'Initials': 'HV', 'LastName': 'Worthington', 'Affiliation': 'School of Dentistry, University of Manchester, Manchester, UK.'}, {'ForeName': 'Marjon', 'Initials': 'M', 'LastName': 'van der Pol', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'Dental Directorate, NHS Education for Scotland, Edinburgh, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Gouick', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Gerald M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': 'School of Medicine, University of St Andrews, St Andrews, UK.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Mitchell', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John Dt', 'Initials': 'JD', 'LastName': 'Norrie', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Sim', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Douglas', 'Affiliation': 'School of Dentistry, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ricketts', 'Affiliation': 'Dental Health Services Research Unit, University of Dundee, Dundee, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24600']
1536,33219629,Does insufficient sleep affect how you learn from reward or punishment? Reinforcement learning after 2 nights of sleep restriction.,"To learn from feedback (trial and error) is essential for all species. Insufficient sleep has been found to reduce the sensitivity to feedback as well as increase reward sensitivity. To determine whether insufficient sleep alters learning from positive and negative feedback, healthy participants (n = 32, mean age 29.0 years, 18 women) were tested once after normal sleep (8 hr time in bed for 2 nights) and once after 2 nights of sleep restriction (4 hr/night) on a probabilistic selection task where learning behaviour was evaluated in three ways: as generalised learning, short-term win-stay/lose-shift learning strategies, and trial-by-trial learning rate. Sleep restriction did not alter the sensitivity to either positive or negative feedback on generalised learning. Also, short-term win-stay/lose-shift strategies were not affected by sleep restriction. Similarly, results from computational models that assess the trial-by-trial update of stimuli value demonstrated no difference between sleep conditions after the first block. However, a slower learning rate from negative feedback when evaluating all learning blocks was found after sleep restriction. Despite a marked increase in sleepiness and slowed learning rate for negative feedback, sleep restriction did not appear to alter strategies and generalisation of learning from positive or negative feedback.",2020,"Despite a marked increase in sleepiness and slowed learning rate for negative feedback, sleep restriction did not appear to alter strategies and generalisation of learning from positive or negative feedback.","['positive and negative feedback, healthy participants (n\xa0=\xa032, mean age 29.0\xa0years, 18 women']","['normal sleep (8\xa0hr time in bed for 2\xa0nights) and once after 2\xa0nights of sleep restriction (4\xa0hr/night) on a probabilistic selection task where learning behaviour was evaluated in three ways: as generalised learning, short-term win-stay/lose-shift learning strategies, and trial-by-trial learning rate', 'Reinforcement learning']","['sleepiness and slowed learning rate for negative feedback, sleep restriction']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]",,0.0191031,"Despite a marked increase in sleepiness and slowed learning rate for negative feedback, sleep restriction did not appear to alter strategies and generalisation of learning from positive or negative feedback.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gerhardsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Danja K', 'Initials': 'DK', 'LastName': 'Porada', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Johan N', 'Initials': 'JN', 'LastName': 'Lundström', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schwarz', 'Affiliation': 'Department of Psychology, Stress Research Institute, Stockholm University, Stockholm, Sweden.'}]",Journal of sleep research,['10.1111/jsr.13236']
1537,33218112,Oxidative Stress in Endurance Cycling Is Reduced Dose-Dependently after One Month of Re-Esterified DHA Supplementation.,"Docosahexaenoic acid (DHA) supplementation can reduce exercise-induced oxidative stress generated during long aerobic exercise, with the minimum dose yet to be elucidated for physically active subjects. In this study, we performed a dose finding with re-esterified DHA in triglyceride form in a randomized double-blind parallel trial at different doses (350, 1050, 1750, and 2450 mg a day) for 4 weeks in males engaged in regular cycling ( n = 100, 7.6 ± 3.7 h/week). The endogenous antioxidant capacity of DHA was quantified as a reduction in the levels of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine (8-OHdG) recollected in 24-h urine samples after 90 min of constant load cycling before and after intervention. To ascertain incorporation of DHA, erythrocyte polyunsaturated fatty acid (PUFA) composition was compared along groups. We found a dose-dependent antioxidant capacity of DHA from 1050 mg with a trend to neutralization for the highest dose of 2450 mg (placebo: n = 13, F = 0.041; 350 mg: n = 10, F = 0.268; 1050 mg: n = 11, F = 7.112; 1750 mg: n = 12, F = 9.681; 2450 mg: n = 10, F = 15.230). In the erythrocyte membrane, the re-esterified DHA increased DHA and omega-3 percentage and decreased omega 6 and the omega-6 to omega-3 ratio, while Eicosapentaenoic acid (EPA) and PUFA remained unchanged. Supplementation of re-esterified DHA exerts a dose-dependent endogenous antioxidant property against moderate-intensity long-duration aerobic exercise in physically active subjects when provided at least 1050 mg a day for 4 weeks.",2020,The endogenous antioxidant capacity of DHA was quantified as a reduction in the levels of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine (8-OHdG) recollected in 24-h urine samples after 90 min of constant load cycling before and after intervention.,"['physically active subjects', 'males engaged in regular cycling ( n = 100, 7.6 ± 3.7 h/week']","['Docosahexaenoic acid (DHA) supplementation', 'placebo']","['DHA, erythrocyte polyunsaturated fatty acid (PUFA) composition', 'DHA and omega-3 percentage and decreased omega 6 and the omega-6 to omega-3 ratio, while Eicosapentaenoic acid (EPA) and PUFA', 'Oxidative Stress']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.235482,The endogenous antioxidant capacity of DHA was quantified as a reduction in the levels of the oxidative stress marker 8-hydroxy-2'-deoxyguanosine (8-OHdG) recollected in 24-h urine samples after 90 min of constant load cycling before and after intervention.,"[{'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'de Salazar', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Torregrosa-García', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Luque-Rubia', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Ávila-Gandía', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}, {'ForeName': 'Joan Carles', 'Initials': 'JC', 'LastName': 'Domingo', 'Affiliation': 'Department of Biochemistry and Molecular Biomedicine, University of Barcelona, 08007 Barcelona, Spain.'}, {'ForeName': 'F Javier', 'Initials': 'FJ', 'LastName': 'López-Román', 'Affiliation': 'Sports Physiology Department, Faculty of Health Sciences, UCAM Universidad Católica San Antonio de Murcia, 30107 Guadalupe (Murcia), Spain.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9111145']
1538,33185618,Escitalopram improves neural functional prognosis and endothelial dysfunction in patients with acute cerebral infarction.,"BACKGROUND
Escitalopram is one of the most commonly used SSRIs at present, which has the characteristics of quick onset, less interactions with other drugs, and relative safety.
OBJECTIVE
This study aims to investigate the effects of escitalopram on neural functional prognoses and endothelial dysfunction after acute ischemic stroke.
METHODS
One hundred eligible patients afflicted with acute ischemic stroke were randomized into two groups: control and treatment groups. Patients in the treatment group received escitalopram in addition to the basic therapies in the control group over a period of 90 days. Neurological deficits were quantified using the National Institutes of Health Stroke Scale (NIHSS) score and Barthel index (BI) score, cognitive impairment was determined using the Mini-Mental State Examination (MMSE) score, depressive symptoms were measured using the 17-item Hamilton Depression Rating Scale (HAMD). Furthermore, post-stroke depression (PSD) was defined based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition), with a HAMD score ≥17. Flow-mediated vascular dilatation (FMD) of the brachial artery was use as a surrogate indicator for endothelial dysfunction assessment with ultrasound.
RESULTS
The mean NIHSS and HAMD scores on day 90 after treatment were significantly lower in the treatment group than in the control group (2.17±0.36 vs. 4.24±0.85; 5.81±1.35 vs. 10.43±4.91; P < 0.01), while the mean BI score and FMD were significantly higher in the treatment group (93.08±6.23 vs. 79.64±7.56, P < 0.01; 8.71±2.35 vs. 5.83±1.21, P < 0.05) than in the control group. The improvement in MMSE score was not significantly different between the two groups.
CONCLUSIONS
Treatment with escitalopram early after ischemic stroke can improve neural functional prognoses and endothelial dysfunction. Escitalopram had less side effects, which is worthy of clinical prophylactic application.",2020,"The mean NIHSS and HAMD scores on day 90 after treatment were significantly lower in the treatment group than in the control group (2.17±0.36 vs. 4.24±0.85; 5.81±1.35 vs. 10.43±4.91; P < 0.01), while the mean BI score and FMD were significantly higher in the treatment group (","['patients with acute cerebral infarction', 'One hundred eligible patients afflicted with acute ischemic stroke']","['escitalopram', 'Escitalopram']","['mean BI score and FMD', 'Mini-Mental State Examination (MMSE) score, depressive symptoms', '17-item Hamilton Depression Rating Scale (HAMD', 'National Institutes of Health Stroke Scale (NIHSS) score and Barthel index (BI) score, cognitive impairment', 'neural functional prognoses and endothelial dysfunction', 'MMSE score', 'side effects', 'neural functional prognosis and endothelial dysfunction', 'mean NIHSS and HAMD scores', 'Flow-mediated vascular dilatation (FMD', 'Neurological deficits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}]",100.0,0.0458939,"The mean NIHSS and HAMD scores on day 90 after treatment were significantly lower in the treatment group than in the control group (2.17±0.36 vs. 4.24±0.85; 5.81±1.35 vs. 10.43±4.91; P < 0.01), while the mean BI score and FMD were significantly higher in the treatment group (","[{'ForeName': 'Jin-Xia', 'Initials': 'JX', 'LastName': 'Cao', 'Affiliation': ""Department of Neuropsychiatry, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Neuropsychiatry, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Yun-Tao', 'Initials': 'YT', 'LastName': 'Sun', 'Affiliation': ""Department of Neuropsychiatry, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Qing-Hong', 'Initials': 'QH', 'LastName': 'Zeng', 'Affiliation': ""Department of Neurology, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Zhen-Dong', 'Initials': 'ZD', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasonography, The Lianyungang Second People's Hospital, Jiangsu, China.""}, {'ForeName': 'Jie-Chun', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, The Lianyungang Second People's Hospital, Jiangsu, China.""}]",Restorative neurology and neuroscience,['10.3233/RNN-201041']
1539,33182392,Impact of the Use of a Larger Forearm Artery on the Efficacy and Safety of Transradial and Transulnar Access: A Randomized Trial with Preprocedural Ultrasonography.,"(1) Background: We aimed to assess the impact of the selection of a larger radial or ulnar artery on the efficacy of access and vascular complications, based on preprocedural ultrasonographic examination. (2) Methods: This prospective, randomized trial included patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI). Patients were randomized into either a larger ulnar artery (UA) or radial artery (RA) group or smaller UA/RA group. The primary endpoint was successful CAG/PCI without crossover to another artery. The secondary endpoints were incidences of radial or ulnar artery occlusion (RAO/UAO) at the 24 h and 30 day follow-up. (3) Results: Between 2017 and 2018, 200 patients (107 men, mean age 68 ± 8 years) were enrolled. The success of CAG/PCI via the access site was 98% and 83% ( p < 0.001) in the larger UA/RA group and smaller UA/RA group, respectively. The independent factor for CAG/PCI success was the larger artery (OR 9.8, 95%CI 2.11-45.5; p < 0.005). The larger UA/RA was superior, with RAO/UAO at 24 h: OR 0.07, 95%CI 0.09-0.61; p < 0.016; and RAO/UAO at 30 days: OR 0.25, 95%CI 0.05-0.12; p < 0.001. (4) Conclusions: Larger artery access was shown to be more efficient and safer than recessive forearm artery access.",2020,"The success of CAG/PCI via the access site was 98% and 83% ( p < 0.001) in the larger UA/RA group and smaller UA/RA group, respectively.","['patients undergoing coronary angiography (CAG) or percutaneous coronary intervention (PCI', 'Between 2017 and 2018, 200 patients (107 men, mean age 68 ± 8 years) were enrolled']","['Transradial and Transulnar Access', 'larger ulnar artery (UA) or radial artery (RA) group or smaller UA/RA group', 'Preprocedural Ultrasonography']","['successful CAG/PCI', 'incidences of radial or ulnar artery occlusion (RAO/UAO', 'success of CAG/PCI via the access site', 'CAG/PCI success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}]",,0.141313,"The success of CAG/PCI via the access site was 98% and 83% ( p < 0.001) in the larger UA/RA group and smaller UA/RA group, respectively.","[{'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Lewandowski', 'Affiliation': 'Cardiology Department, Centre of Postgraduate Medical Education, Grochowski Hospital, 04-073 Warsaw, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Zuk', 'Affiliation': 'Cardiology Department, Centre of Postgraduate Medical Education, Grochowski Hospital, 04-073 Warsaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Slomski', 'Affiliation': 'Cardiology Department, Centre of Postgraduate Medical Education, Grochowski Hospital, 04-073 Warsaw, Poland.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Maciejewski', 'Affiliation': 'Cardiology Department, Centre of Postgraduate Medical Education, Grochowski Hospital, 04-073 Warsaw, Poland.'}, {'ForeName': 'Bogumil', 'Initials': 'B', 'LastName': 'Ramotowski', 'Affiliation': 'Cardiology Department, Centre of Postgraduate Medical Education, Grochowski Hospital, 04-073 Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Budaj', 'Affiliation': 'Cardiology Department, Centre of Postgraduate Medical Education, Grochowski Hospital, 04-073 Warsaw, Poland.'}]",Journal of clinical medicine,['10.3390/jcm9113607']
1540,33182408,Clinical and Molecular-Genetic Insights into the Role of Oxidative Stress in Diabetic Retinopathy: Antioxidant Strategies and Future Avenues.,"Reactive oxygen species (ROS) overproduction and ROS-signaling pathways activation attack the eyes. We evaluated the oxidative stress (OS) and the effects of a daily, core nutritional supplement regimen containing antioxidants and omega 3 fatty acids (A/ω3) in type 2 diabetics (T2DM). A case-control study was carried out in 480 participants [287 T2DM patients with (+)/without (-) diabetic retinopathy (DR) and 193 healthy controls (CG)], randomly assigned to a daily pill of A/ω3. Periodic evaluation through 38 months allowed to outline patient characteristics, DR features, and classic/OS blood parameters. Statistics were performed by the SPSS 24.0 program. Diabetics displayed significantly higher circulating pro-oxidants ( p = 0.001) and lower antioxidants ( p = 0.0001) than the controls. Significantly higher plasma malondialdehyde/thiobarbituric acid reactive substances (MDA/TBARS; p = 0.006) and lower plasma total antioxidant capacity (TAC; p = 0.042) and vitamin C (0.020) was found in T2DM + DR versus T2DM-DR. The differential expression profile of solute carrier family 23 member 2 (SLC23A2) gene was seen in diabetics versus the CG ( p = 0.001), and in T2DM + DR versus T2DM - DR ( p < 0.05). The A/ω3 regime significantly reduced the pro-oxidants ( p < 0.05) and augmented the antioxidants ( p < 0.05). This follow-up study supports that a regular A/ω3 supplementation reduces the oxidative load and may serve as a dietary prophylaxis/adjunctive intervention for patients at risk of diabetic blindness.",2020,Diabetics displayed significantly higher circulating pro-oxidants ( p = 0.001) and lower antioxidants ( p = 0.0001) than the controls.,"['Diabetic Retinopathy', 'type 2 diabetics (T2DM', ' diabetic retinopathy (DR) and 193 healthy controls (CG', '480 participants [287 T2DM patients with (+)/without', 'patients at risk of diabetic blindness']",[],"['lower plasma total antioxidant capacity (TAC', 'oxidative stress (OS', 'plasma malondialdehyde/thiobarbituric acid reactive substances (MDA/TBARS', 'circulating pro-oxidants', 'pro-oxidants']","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0854067', 'cui_str': 'Diabetic blindness'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}]",480.0,0.0155257,Diabetics displayed significantly higher circulating pro-oxidants ( p = 0.001) and lower antioxidants ( p = 0.0001) than the controls.,"[{'ForeName': 'Silvia M', 'Initials': 'SM', 'LastName': 'Sanz-González', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"", Fundación Investigación Sanitaria y Biomédica (FISABIO), Ave. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'José J', 'Initials': 'JJ', 'LastName': 'García-Medina', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"", Fundación Investigación Sanitaria y Biomédica (FISABIO), Ave. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Zanón-Moreno', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"", Fundación Investigación Sanitaria y Biomédica (FISABIO), Ave. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'María I', 'Initials': 'MI', 'LastName': 'López-Gálvez', 'Affiliation': 'Spanish Net of Ophthalmic Research ""OFTARED"" RD16/0008/0022, of the Institute of Health Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Galarreta-Mira', 'Affiliation': 'Spanish Net of Ophthalmic Research ""OFTARED"" RD16/0008/0022, of the Institute of Health Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Duarte', 'Affiliation': 'Department of Ophthalmology, Complexo Hospitalar ""Entre Douro e Vouga"", 4520-211 Santa Maria da Feira, Portugal.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Valero-Velló', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"", Fundación Investigación Sanitaria y Biomédica (FISABIO), Ave. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': 'Ana I', 'Initials': 'AI', 'LastName': 'Ramírez', 'Affiliation': 'Spanish Net of Ophthalmic Research ""OFTARED"" RD16/0008/0022, of the Institute of Health Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'J Fernando', 'Initials': 'JF', 'LastName': 'Arévalo', 'Affiliation': 'Wilmer s Eye Institute at the Johns Hopkins Hospital, Baltimore, MD 21287, USA.'}, {'ForeName': 'María D', 'Initials': 'MD', 'LastName': 'Pinazo-Durán', 'Affiliation': 'Ophthalmic Research Unit ""Santiago Grisolía"", Fundación Investigación Sanitaria y Biomédica (FISABIO), Ave. Gaspar Aguilar 90, 46017 Valencia, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Valencia Study Group On Diabetic Retinopathy Vsdr Report Number', 'Affiliation': ''}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9111101']
1541,33182513,Influence of Internal Thoracic Artery Harvesting on Sternal Osteoblastic Activity and Perfusion.,"The purpose of this study was to assess the sternal osteoblastic activity and perfusion in the early period after a coronary artery bypass graft (CABG) using single-photon emission computed tomography (SPECT) and three-phasic dynamic scintigraphy (3PDS) with 99mTc methylene diphosphonate (MDP).
METHODS
The study group consisted of 57 male patients that were 57.3 ± 6.6 years of age. Thirty-six of them were randomized into two groups: in group I ( n = 18), the internal thoracic artery (ITA) was skeletonized, and in group II ( n = 18), the ITA was pedicled. All the patients in groups I and II underwent an off-pump CABG using 1.7 ± 0.3 grafts, including one anastomosis of the ITA to the left anterior descending coronary artery. The control group III ( n = 21) consisted of patients that underwent mitral valve repair surgery, in whom the sternotomy without the ITA harvesting was performed. The 3PDS and SPECT of the thorax with 99mTc MDP were performed 2 weeks after surgery.
RESULTS
The sternal phosphates uptake in group I was approximately twice as high as in group II and approximately 1.5 times higher than in group III ( p < 0.05). The MDP uptake asymmetry after the ITA skeletonization was the same as in the group with both intact ITAs. In contrast, after the pedicled ITA harvesting, the osteoblastic activity of the ipsilateral side of the sternum was lower than in the contralateral one. There was no statistically significant difference in scintillation count in the xiphoid process between groups I and II ( p > 0.05); however, we observed a significant difference in the manubrium and body ( p < 0.05).
CONCLUSION
The main factor that improved the sternal perfusion after a CABG was the preservation of branches supplying the sternum using the skeletonization technique of ITA harvesting.",2020,"There was no statistically significant difference in scintillation count in the xiphoid process between groups I and II ( p > 0.05); however, we observed a significant difference in the manubrium and body ( p < 0.05).
",['57 male patients that were 57.3 ± 6.6 years of age'],"['mitral valve repair surgery', 'internal thoracic artery (ITA', 'coronary artery bypass graft (CABG) using single-photon emission computed tomography (SPECT) and three-phasic dynamic scintigraphy (3PDS) with 99mTc methylene diphosphonate (MDP', 'Internal Thoracic Artery Harvesting']","['sternal osteoblastic activity and perfusion', 'sternal perfusion', 'sternal phosphates uptake', 'scintillation count', 'osteoblastic activity', 'MDP uptake asymmetry', 'Sternal Osteoblastic Activity and Perfusion']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0396849', 'cui_str': 'Mitral valvuloplasty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0226276', 'cui_str': 'Structure of internal thoracic artery'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0039416', 'cui_str': 'Technetium Tc 99m Medronate'}, {'cui': 'C0066351', 'cui_str': 'methylene diphosphonate'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0066351', 'cui_str': 'methylene diphosphonate'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}]",57.0,0.0154513,"There was no statistically significant difference in scintillation count in the xiphoid process between groups I and II ( p > 0.05); however, we observed a significant difference in the manubrium and body ( p < 0.05).
","[{'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Mamchur', 'Affiliation': 'Department of Cardiovascular Surgery, Research Institute for Complex Issues of Cardiovascular Diseases, 650002 Kemerovo, Russia.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vecherskii', 'Affiliation': 'Department of Cardiovascular Surgery, Research Institute of Cardiology, 634012 Tomsk, Russia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Chichkova', 'Affiliation': 'Department of Cardiovascular Surgery, Research Institute for Complex Issues of Cardiovascular Diseases, 650002 Kemerovo, Russia.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10110921']
1542,33182537,Physical Fitness Levels among Colon Cancer Survivors with a Stoma: A Preliminary Study.,"Background and Objectives: Stoma surgery is linked to reduced physical activity in colon cancer survivors and leads to decreased physical fitness, activity of daily living dysfunction, and poorer quality of life. However, few studies have investigated the physical fitness levels of colon cancer survivors living with stomas. This study aimed to compare the physical fitness levels of colon cancer survivors with stomas and healthy adults, assessing them in a variety of dimensions (e.g., strength and flexibility) and in terms of physical fitness age (PFA), an integrated index of overall fitness. Materials and Methods: The study population consisted of 17 colon cancer survivors with (stoma group) and 20 healthy adults without (control group) a stoma. Physical fitness was assessed using a battery of five tests: repeated back-and-forth steps, 30-s chair stand, chair sit-and-reach, grip strength, and single-leg balance with eyes closed. Respective performance values were converted into PFA, which was compared between the stoma and control groups. Fitness indicators were compared between groups by analysis of covariance, and PFA and chronological age (CA) by paired t -tests. Results: The mean ages (±standard deviation) of the stoma and control groups were 74.1 ± 7.9 and 73.5 ± 7.1 years, respectively. Colon cancer survivors with stomas had poorer lower limb muscular strength, endurance, and flexibility than controls. In the stoma group, the marginal mean (±standard error) PFA was calculated to be 82.5 ± 3.7 years, significantly higher than the CA and PFA of the control group (69.6 ± 3.9 years). Conclusions: Colon cancer survivors with stomas have lower physical fitness levels than healthy adults, with apparent deficits in lower limb flexibility, muscular strength, and endurance. Our findings demonstrated the need for exercise interventions in this population, focusing on these dimensions of fitness. However, our results should be corroborated by means of a larger-scale comparison in future studies.",2020,"Colon cancer survivors with stomas have lower physical fitness levels than healthy adults, with apparent deficits in lower limb flexibility, muscular strength, and endurance.","['colon cancer survivors', 'colon cancer survivors with stomas and healthy adults', '17 colon cancer survivors with (stoma group) and 20 healthy adults without (control group) a stoma', 'colon cancer survivors living with stomas', 'Colon cancer survivors', 'healthy adults', 'Colon Cancer Survivors with a Stoma']",['Stoma surgery'],"['Physical fitness', 'PFA', 'limb muscular strength, endurance, and flexibility', 'Physical Fitness Levels', 'limb flexibility, muscular strength, and endurance', 'physical fitness, activity of daily living dysfunction, and poorer quality of life', 'marginal mean (±standard error']","[{'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",17.0,0.0327347,"Colon cancer survivors with stomas have lower physical fitness levels than healthy adults, with apparent deficits in lower limb flexibility, muscular strength, and endurance.","[{'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Nakagawa', 'Affiliation': 'School of Nursing, Takarazuka University, 1-13-16 Shibata, Kita-ku, Osaka City, Osaka 530-0012, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Sasai', 'Affiliation': 'Research Team for Promoting Independence and Mental Health, Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan.'}, {'ForeName': 'Kiyoji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Institute of Health and Sport Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110601']
1543,33186193,Effect of Gum Chewing on Recovery After Surgery for Colorectal Surgery Patients: A Randomized Controlled Trial.,"The aim of this study was to determine the role of chewing gum in bowel functions after left colon and/or rectal surgery. In this randomized controlled study, the sample consisted of adult patients who had undergone elective open left colon and/or rectal surgical interventions under general anesthesia. The sample comprised 17 patients in the experimental group and control group. The patients in the experimental group chewed a sugar-free gum after removal of their nasogastric tubes, 3 times a day for 45 minutes, from the first postoperative morning until they had first flatus. Routine care was maintained for the patients in the control group until their first flatus. The effects of chewing gum on the length of time until first flatus, the first defecation in the postoperative period, and the discharge of patients were investigated. The patients in the experimental group had flatus and defecation earlier, and the duration of their hospital stay was shorter than those of patients in the control group. It was found that gum chewing as a physiological method promotes the early initiation of bowel functions and, consequently, shortens the hospital stay after elective left colon and/or rectal surgery.",2020,"The patients in the experimental group had flatus and defecation earlier, and the duration of their hospital stay was shorter than those of patients in the control group.","['bowel functions after left colon and/or rectal surgery', 'Colorectal Surgery Patients', 'adult patients who had undergone elective open left colon and/or rectal surgical interventions under general anesthesia']","['sugar-free gum', 'chewing gum', 'Gum Chewing']","['flatus and defecation earlier, and the duration of their hospital stay', 'length of time until first flatus, the first defecation', 'Recovery', 'hospital stay']","[{'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0227388', 'cui_str': 'Left colon structure'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}]","[{'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0250731,"The patients in the experimental group had flatus and defecation earlier, and the duration of their hospital stay was shorter than those of patients in the control group.","[{'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Duluklu', 'Affiliation': 'Burcu Duluklu, PhD, MSc, RN, Surgical Nursing Department, Faculty of Nursing, Hacettepe University, Ankara, Turkey. Sevilay Senol Celik, PhD, RN, is Professor, Faculty of Nursing, Koc University, Istanbul, Turkey.'}, {'ForeName': 'Sevilay', 'Initials': 'S', 'LastName': 'Senol Celik', 'Affiliation': ''}]",Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates,['10.1097/SGA.0000000000000481']
1544,33186765,Clinical Outcomes in People with Difficult-to-Control Asthma Using Electronic Monitoring to Support Medication Adherence.,"BACKGROUND
Nonadherence in difficult-to-control asthma can be identified using 7-day FeNO suppression testing where patients take additional fluticasone via Diskus with an Inhaler Compliance Assessment (INCA) acoustic monitoring device attached, and self-measure FeNO at home. However, this is inconvenient for patients attending a tertiary center and limited by FeNO meter availability. It is not known if this approach alters clinical outcomes.
OBJECTIVES
To examine patient acceptability and the effectiveness of replacing usual combination inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA) therapy with a fluticasone/salmeterol Diskus 500+INCA for 28 days as the initial intervention, compared with the 7-day FeNO suppression test, and to explore clinical outcomes after INCA monitoring.
METHODS
A service evaluation of FeNO suppression testing was undertaken in clinical practice.
RESULTS
Twenty-one of 23 subjects offered replacement of their usual ICS/LABA with fluticasone/salmeterol+INCA as the initial intervention accepted and completed 28 days of monitoring. Fourteen (66.6%) patients reduced their FeNO by >42% (FeNO suppressors), accompanied by improvements in forced expiratory volume in 1 second, Asthma Control Questionnaire, and blood eosinophils, similar to the 7-day test (n = 74). Twenty-two of 62 (35.5%) FeNO suppressors progressed to biological therapy, compared with 24 of 33 (72.7%) nonsuppressors (P = .0006). FeNO suppressors taking maintenance prednisolone (n = 13) who did not receive biological therapy reduced the median baseline dose from 10 to 3 mg, with further reductions limited by adrenal suppression.
CONCLUSION
Replacing existing inhaled therapy with fluticasone/salmeterol+INCA for 28 days is acceptable to the majority of people with difficult-to-control asthma and identifies prior medication nonadherence. INCA monitoring coupled with clinical support potentially improves patient adherence and asthma control, preventing unnecessary progression to biological therapy.",2020,"FeNO suppressors progressed to biologic therapy, compared to 24/33 (72.7%) non suppressors (p=0.0006).","['patients attending a tertiary centre and limited by FeNO meter availability', 'people with difficult-to-control asthma using electronic monitoring to support medication adherence']","['fluticasone/salmeterol+INCA', 'FeNO suppressors taking maintenance prednisolone', 'biological therapy', 'replacing usual combination inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy with a fluticasone/salmeterol Diskus 500+INCA', 'INCA']","['FEV1, ACQ and blood eosinophils', 'patient adherence and asthma control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]","[{'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0939232', 'cui_str': 'salmeterol and fluticasone'}, {'cui': 'C0337871', 'cui_str': 'Inca'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0418105,"FeNO suppressors progressed to biologic therapy, compared to 24/33 (72.7%) non suppressors (p=0.0006).","[{'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Boddy', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Shamsa', 'Initials': 'S', 'LastName': 'Naveed', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Craner', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Murphy', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradding', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals of Leicester NHS Trust, Glenfield Hospital, Leicester, United Kingdom; Department of Respiratory Sciences, Institute for Lung Health, University of Leicester, Glenfield Hospital, Leicester, United Kingdom. Electronic address: pb46@le.ac.uk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.10.059']
1545,33187116,Long-Term Effects of a Cognitive Behavioral Conference Call Intervention on Depression in Non-Professional Caregivers.,"Recent evidence supports the efficacy of conference call cognitive-behavioral interventions in preventing depression in caregivers at post-intervention, but we do not know whether the results are sustained long term. The main objective of this study was to evaluate the long-term efficacy of a cognitive-behavioral intervention administered by telephone conference call in preventing depression in caregivers with elevated depressive symptoms, comparing all components of the intervention versus only the behavioral ones. A randomized controlled trial was conducted using a dismantling strategy. At total of 219 caregivers were randomly assigned to a cognitive-behavioral conference call intervention (CBCC; n = 69), a behavioral-activation conference call intervention (BACC; n = 70), or a usual care control group (CG, n = 80). Information was collected on depressive symptoms and depression at pre-intervention and at 1, 3, 6, 12, and 36 months post-intervention. At 36 months, there was a reduction in depressive symptoms ( p < 0.001) and a lower incidence of major depressive episodes in both the CBCC and BACC groups compared to CG (8.7%, 8.6%, and 33.7%, respectively). The results show that a conference call intervention was effective in the long term to prevent depression in caregivers and that the behavioral-activation component was comparable to the complete cognitive-behavioral protocol.",2020,"At 36 months, there was a reduction in depressive symptoms ( p < 0.001) and a lower incidence of major depressive episodes in both the CBCC and BACC groups compared to CG (8.7%, 8.6%, and 33.7%, respectively).","['Non-Professional Caregivers', 'caregivers with elevated depressive symptoms', 'At total of 219 caregivers']","['cognitive-behavioral conference call intervention (CBCC; n = 69), a behavioral-activation conference call intervention (BACC; n = 70), or a usual care control', 'cognitive-behavioral intervention administered by telephone conference call', 'conference call cognitive-behavioral interventions', 'Cognitive Behavioral Conference Call Intervention']","['major depressive episodes', 'depressive symptoms']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517648', 'cui_str': '219'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",219.0,0.0452861,"At 36 months, there was a reduction in depressive symptoms ( p < 0.001) and a lower incidence of major depressive episodes in both the CBCC and BACC groups compared to CG (8.7%, 8.6%, and 33.7%, respectively).","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Lopez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Vázquez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Ángela J', 'Initials': 'ÁJ', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Department of Psychology, University of A Coruña, 15008 A Coruña, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blanco', 'Affiliation': 'Department of Evolutionary and Educational Psychology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Díaz', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Páramo', 'Affiliation': 'Department of Psychiatry, Radiology and Public Health, University of Santiago de Compostela, 15782 Santiago de Compostela, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228329']
1546,33187167,Does Upper Cervical Manual Therapy Provide Additional Benefit in Disability and Mobility over a Physiotherapy Primary Care Program for Chronic Cervicalgia? A Randomized Controlled Trial.,"Introduction : Neck pain is a condition with a high incidence in primary care. Patients with chronic neck pain often experience reduction in neck mobility. However, no study to date has investigated the effects of manual mobilization of the upper cervical spine in patients with chronic mechanical neck pain and restricted upper cervical rotation. Objective : To evaluate the effect of adding an upper cervical translatoric mobilization or an inhibitory suboccipital technique to a conventional physical therapy protocol in patients with chronic neck pain test on disability and cervical range of motion. Design : Randomized controlled trial. Methods : Seventy-eight patients with chronic neck pain and restricted upper cervical rotation were randomized in three groups: Upper cervical translatoric mobilization group, inhibitory suboccipital technique group, or control group. The neck disability index, active cervical mobility, and the flexion-rotation test were assessed at baseline (T0), after the treatment (T1), and at three-month follow-up (T2). Results : There were no statistically significant differences between groups in neck disability index. The upper cervical translatoric mobilization group showed a significant increase in the flexion-rotation test to the more restricted side at T1 (F = 5.992; p < 0.004) and T2 (F = 5.212; p < 0.007) compared to the control group. The inhibitory suboccipital technique group showed a significant increase in the flexion-rotation test to the less restricted side at T1 (F = 3.590; p < 0.027). All groups presented high percentages of negative flexion-rotation tests. (T1: 69.2% upper neck translator mobilization group; 38.5% suboccipital inhibition technique group, 19.2% control group; at T2: 80.8%; 46.2% and 26.9% respectively). No significant differences in the active cervical mobility were found between groups. Conclusion: Adding manual therapy to a conventional physical therapy protocol for the upper cervical spine increased the flexion-rotation test in the short- and mid-term in patients with chronic neck pain. No changes were found in the neck disability index and the global active cervical range of motion.",2020,The upper cervical translatoric mobilization group showed a significant increase in the flexion-rotation test to the more restricted side at T1 (F = 5.992; p < 0.004) and T2 (F = 5.212; ,"['Methods : Seventy-eight patients with chronic neck pain and restricted upper cervical rotation', 'patients with chronic mechanical neck pain and restricted upper cervical rotation', 'patients with chronic neck pain test on disability and cervical range of motion', 'Patients with chronic neck pain often experience reduction in neck mobility', 'patients with chronic neck pain']","['conventional physical therapy protocol', 'Upper cervical translatoric mobilization group, inhibitory suboccipital technique group, or control group', 'upper cervical translatoric mobilization or an inhibitory suboccipital technique to a conventional physical therapy protocol']","['Neck pain', 'neck disability index and the global active cervical range of motion', 'neck disability index, active cervical mobility, and the flexion-rotation test', 'active cervical mobility', 'negative flexion-rotation tests', 'neck disability index', 'flexion-rotation test']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442187', 'cui_str': 'Suboccipital approach'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0178091', 'cui_str': 'Rotational test'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",78.0,0.0387853,The upper cervical translatoric mobilization group showed a significant increase in the flexion-rotation test to the more restricted side at T1 (F = 5.992; p < 0.004) and T2 (F = 5.212; ,"[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'González-Rueda', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hidalgo-García', 'Affiliation': 'Facultad de Ciencias de la Salud, Unidad de Investigación en Fisioterapia, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Jacobo', 'Initials': 'J', 'LastName': 'Rodríguez-Sanz', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Bueno-Gracia', 'Affiliation': 'Facultad de Ciencias de la Salud, Unidad de Investigación en Fisioterapia, Universidad de Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Pérez-Bellmunt', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'Pere Ramón', 'Initials': 'PR', 'LastName': 'Rodríguez-Rubio', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-de-Celis', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universitat Internacional de Catalunya, 08195 Barcelona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228334']
1547,33187261,Efficacy and Safety of Combined Extracts of Cornus officinalis and Ribes fasciculatum for Body Fat Reduction in Overweight Women.,"Obesity is a medical condition that presents excessive fat accumulation with high risk of serious chronic diseases. The aim of this clinical trial is to investigate the anti-obesity effects of Cornus officinalis (CO) and Ribes fasciculatum (RF) on body fat reduction in Korean overweight women. A total of 147 overweight female participants enrolled in double-blinded clinical trial for 12 weeks and 76 participants completed the clinical study. Participants were treated with four CO and RF mixture (COEC; 400 mg per tablet) or four placebo tablets once a day. Obesity associated parameters (body weight, body mass index (BMI), waist circumference, waist-to-hip ratio, body fat percentage and body fat mass) and safety assessment were analyzed. After 12 weeks of COEC treatment, primary outcomes such as body fat percentage (0.76% vs. 0.01%; p = 0.022) and mass (1.1 kg vs. 0.5 kg; p = 0.049) were significantly decreased. In addition, the results were statistically significant between the COEC and placebo groups, strongly indicated that COEC had anti-obesity effects on overweight women. Secondary outcomes-including body weight, waist and hip circumference, waist-to-hip ratio, body mass index and computed tomography measurement of visceral fat area, subcutaneous fat area, total abdominal fat area and visceral-to-subcutaneous fat ratio-were reduced in COEC-treated group, but no statistical differences were found between the COEC and placebo groups. The safety assessment did not differ between the two groups. These results suggest that treatment of COEC extract reduces body fat percentage and mass in Korean overweight women, indicating it as a protective functional agent for obesity.",2020,The safety assessment did not differ between the two groups.,"['Korean overweight women', 'Overweight Women', '147 overweight female participants enrolled in double-blinded clinical trial for 12 weeks and 76 participants completed the clinical study']","['COEC', 'COEC extract', 'placebo tablets', 'CO and RF mixture (COEC', 'Combined Extracts of Cornus officinalis and Ribes fasciculatum', 'Cornus officinalis (CO) and Ribes fasciculatum (RF']","['body fat percentage', 'Obesity associated parameters (body weight, body mass index (BMI), waist circumference, waist-to-hip ratio, body fat percentage and body fat mass) and safety assessment', 'body weight, waist and hip circumference, waist-to-hip ratio, body mass index and computed tomography measurement of visceral fat area, subcutaneous fat area, total abdominal fat area and visceral-to-subcutaneous fat ratio']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0950010', 'cui_str': 'Cornus'}, {'cui': 'C1080864', 'cui_str': 'Currants'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",147.0,0.0458033,The safety assessment did not differ between the two groups.,"[{'ForeName': 'Eunkuk', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Chang Gun', 'Initials': 'CG', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jeonghyun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}, {'ForeName': 'Jae-Heon', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul 03181, Korea.'}, {'ForeName': 'Young Gyu', 'Initials': 'YG', 'LastName': 'Cho', 'Affiliation': 'Department of Family Medicine, Seoul Paik Hospital, Inje University College of Medicine, Seoul 04551, Korea.'}, {'ForeName': 'Seon-Yong', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Department of Medical Genetics, Ajou University School of Medicine, Suwon 16499, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9113629']
1548,33187361,"Effect of an Olive Vegetation Water Phenolic Extract on the Physico-Chemical, Microbiological and Sensory Traits of Shrimp ( Parapenaeus longirostris ) during the Shelf-Life.","The aim of this study was to evaluate the effects of phenolic extract derived from olive vegetation water (PEOVW) in deep-water rose shrimps ( Parapenaeus longirostris ) at the day of packaging (D0) and after three (D3), six (D6) and eight (D8) days of refrigerated storage. Freshly caught shrimps were randomly divided into four groups: the phenolic extract (PE) group (2 g/L of phenols); the sulfites (S) group (0.5% sodium metabisulfite solution); the phenolic extract + sulfites (PE + S) group (0.25% sodium metabisulfite solution with 1 g/L of phenols), and the control (CTRL) group (tap water). Concerning color coordinates, there were no variations either between groups or over time, while it is important to highlight that phenolic extract (PE group) led to a significant reduction in total volatile basic nitrogen (TVB-N; p < 0.001) and thiobarbituric reactive substances (TBARS; p < 0.001) values. Furthermore, PE also had a relevant effect in reducing bacterial counts and decreasing the microbial development. Finally, as concerns melanosis, the effect of phenolic extract alone was marginal, but when combined with half a dose of sodium metabisulfite, it was as effective as the shrimps treated with only sodium metabisulfite in delaying black spots ( p < 0.05). These results are very promising with a view to commercializing additive-free shrimps.",2020,"Concerning color coordinates, there were no variations either between groups or over time, while it is important to highlight that phenolic extract (PE group) led to a significant reduction in total volatile basic nitrogen (TVB-N; p < 0.001) and thiobarbituric reactive substances (TBARS; p < 0.001) values.",['Freshly caught shrimps'],"['Olive Vegetation Water Phenolic Extract', 'phenolic extract (PE) group (2 g/L of phenols); the sulfites (S) group (0.5% sodium metabisulfite solution); the phenolic extract + sulfites (PE + S) group (0.25% sodium metabisulfite solution with 1 g/L of phenols), and the control (CTRL', 'phenolic extract derived from olive vegetation water (PEOVW', 'phenolic extract']","['Physico-Chemical, Microbiological and Sensory Traits of Shrimp ( Parapenaeus longirostris ', 'thiobarbituric reactive substances', 'total volatile basic nitrogen', 'bacterial counts']","[{'cui': 'C0231617', 'cui_str': 'Catch'}, {'cui': 'C0457931', 'cui_str': 'Shrimp'}]","[{'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C1285498', 'cui_str': 'Vegetation'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0359916', 'cui_str': 'Substance with phenol structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0038750', 'cui_str': 'Sulfite salt'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0074744', 'cui_str': 'sodium metabisulfite'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0457931', 'cui_str': 'Shrimp'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",,0.0223254,"Concerning color coordinates, there were no variations either between groups or over time, while it is important to highlight that phenolic extract (PE group) led to a significant reduction in total volatile basic nitrogen (TVB-N; p < 0.001) and thiobarbituric reactive substances (TBARS; p < 0.001) values.","[{'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Miraglia', 'Affiliation': 'Department of Veterinary Medicine, University of Perugia, Via San Costanzo 4, 06126 Perugia, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Castrica', 'Affiliation': 'Department of Health, Animal Science and Food Safety ""Carlo Cantoni"", Università degli Studi di Milano, Via Celoria 10, 20133 Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Menchetti', 'Affiliation': 'Department of Agricultural and Agri-Food Sciences and Technologies, University of Bologna, Viale Fanin 46, 40138 Bologna, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Esposto', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Branciari', 'Affiliation': 'Department of Veterinary Medicine, University of Perugia, Via San Costanzo 4, 06126 Perugia, Italy.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ranucci', 'Affiliation': 'Department of Veterinary Medicine, University of Perugia, Via San Costanzo 4, 06126 Perugia, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Urbani', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Sordini', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Veneziani', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Servili', 'Affiliation': 'Department of Agricultural, Food and Environmental Sciences, University of Perugia, Via San Costanzo s.n.c., 06126 Perugia, Italy.'}]","Foods (Basel, Switzerland)",['10.3390/foods9111647']
1549,33189049,Dose distribution correction for the influence of magnetic field using a deep convolutional neural network for online MR-guided adaptive radiotherapy.,"PURPOSE
This study aimed to develop a deep convolutional neural network (CNN)-based dose distribution conversion approach for the correction of the influence of a magnetic field for online MR-guided adaptive radiotherapy.
METHODS
Our model is based on DenseNet and consists of two 2D input channels and one 2D output channel. These three types of data comprise dose distributions without a magnetic field (uncorrected), electron density (ED) maps, and dose distributions with a magnetic field. These data were generated as follows: both types of dose distributions were created using 15-field IMRT in the same conditions except for the presence or absence of a magnetic field with the GPU Monte Carlo dose in Monaco version 5.4; ED maps were acquired with planning CT images using a clinical CT-to-ED table at our institution. Data for 50 prostate cancer patients were used; 30 patients were allocated for training, 10 for validation, and 10 for testing using 4-fold cross-validation based on rectum gas volume. The accuracy of the model was evaluated by comparing 2D gamma-indexes against the dose distributions in each irradiation field with a magnetic field (true).
RESULTS
The gamma indexes in the body for CNN-corrected uncorrected dose against the true dose were 94.95% ± 4.69% and 63.19% ± 3.63%, respectively. The gamma indexes with 2%/2-mm criteria were improved by 10% in most test cases (99.36%).
CONCLUSIONS
Our results suggest that the CNN-based approach can be used to correct the dose-distribution influences with a magnetic field in prostate cancer treatment.",2020,Our results suggest that the CNN-based approach can be used to correct the dose-distribution influences with a magnetic field in prostate cancer treatment.,['50 prostate cancer patients were used; 30 patients'],[],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],50.0,0.0301308,Our results suggest that the CNN-based approach can be used to correct the dose-distribution influences with a magnetic field in prostate cancer treatment.,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Kajikawa', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan; Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Kadoya', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan. Electronic address: kadoya.n@rad.med.tohoku.ac.jp.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hikaru', 'Initials': 'H', 'LastName': 'Nemoto', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan; Department of Radiotherapy, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriyoshi', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takahito', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Department of Medical Physics, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Katsuta', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Dobashi', 'Affiliation': 'Department of Radiological Technology, School of Health Sciences, Faculty of Medicine, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Takeda', 'Affiliation': 'Department of Radiological Technology, School of Health Sciences, Faculty of Medicine, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Radiology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Jingu', 'Affiliation': 'Department of Radiation Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB),['10.1016/j.ejmp.2020.11.002']
1550,33196154,"N-of-1 Trial of a Statin, Placebo, or No Treatment to Assess Side Effects.",,2020,,[],"['Statin, Placebo']",[],[],"[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.187591,,"[{'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Wood', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Howard', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Finegold', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Nowbar', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Ahran D', 'Initials': 'AD', 'LastName': 'Arnold', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Rajkumar', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Imperial College London, London, United Kingdom research@cardiologists.london.'}, {'ForeName': 'Jaimini', 'Initials': 'J', 'LastName': 'Cegla', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Stride', 'Affiliation': 'Sheffield University Management School, Sheffield, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sever', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Norton', 'Affiliation': ""King's College London, London, United Kingdom.""}, {'ForeName': 'Simon A M', 'Initials': 'SAM', 'LastName': 'Thom', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Shun-Shin', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Darrel P', 'Initials': 'DP', 'LastName': 'Francis', 'Affiliation': 'Imperial College London, London, United Kingdom.'}]",The New England journal of medicine,['10.1056/NEJMc2031173']
1551,33196155,Rivaroxaban in Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve.,"BACKGROUND
The effects of rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain.
METHODS
In this randomized trial, we compared rivaroxaban (20 mg once daily) with dose-adjusted warfarin (target international normalized ratio, 2.0 to 3.0) in patients with atrial fibrillation and a bioprosthetic mitral valve. The primary outcome was a composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months.
RESULTS
A total of 1005 patients were enrolled at 49 sites in Brazil. A primary-outcome event occurred at a mean of 347.5 days in the rivaroxaban group and 340.1 days in the warfarin group (difference calculated as restricted mean survival time, 7.4 days; 95% confidence interval [CI], -1.4 to 16.3; P<0.001 for noninferiority). Death from cardiovascular causes or thromboembolic events occurred in 17 patients (3.4%) in the rivaroxaban group and in 26 (5.1%) in the warfarin group (hazard ratio, 0.65; 95% CI, 0.35 to 1.20). The incidence of stroke was 0.6% in the rivaroxaban group and 2.4% in the warfarin group (hazard ratio, 0.25; 95% CI, 0.07 to 0.88). Major bleeding occurred in 7 patients (1.4%) in the rivaroxaban group and in 13 (2.6%) in the warfarin group (hazard ratio, 0.54; 95% CI, 0.21 to 1.35). The frequency of other serious adverse events was similar in the two groups.
CONCLUSIONS
In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months. (Funded by PROADI-SUS and Bayer; RIVER ClinicalTrials.gov number, NCT02303795.).",2020,"In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months.","['patients with atrial fibrillation and a bioprosthetic mitral valve remain uncertain', 'Patients with Atrial Fibrillation and a Bioprosthetic Mitral Valve', 'patients with atrial fibrillation and a bioprosthetic mitral valve', '1005 patients were enrolled at 49 sites in Brazil']","['dose-adjusted warfarin', 'rivaroxaban', 'Rivaroxaban', 'warfarin']","['Death from cardiovascular causes or thromboembolic events', 'frequency of other serious adverse events', 'mean survival time', 'Major bleeding', 'death, major cardiovascular events, or major bleeding', 'incidence of stroke', 'composite of death, major cardiovascular events (stroke, transient ischemic attack, systemic embolism, valve thrombosis, or hospitalization for heart failure), or major bleeding at 12 months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",1005.0,0.25033,"In patients with atrial fibrillation and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin with respect to the mean time until the primary outcome of death, major cardiovascular events, or major bleeding at 12 months.","[{'ForeName': 'Helio P', 'Initials': 'HP', 'LastName': 'Guimarães', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Idelzuita L', 'Initials': 'IL', 'LastName': 'Liporace', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Roney O', 'Initials': 'RO', 'LastName': 'Sampaio', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Tarasoutchi', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann-Filho', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'de Lemos Soares Patriota', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Tiago L L', 'Initials': 'TLL', 'LastName': 'Leiria', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lamprea', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Dalton B', 'Initials': 'DB', 'LastName': 'Precoma', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Atik', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fabio S', 'Initials': 'FS', 'LastName': 'Silveira', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fabio R', 'Initials': 'FR', 'LastName': 'Farias', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Diogo O', 'Initials': 'DO', 'LastName': 'Barreto', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Adail P', 'Initials': 'AP', 'LastName': 'Almeida', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Zilli', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'de Souza Neto', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Cavalcante', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Fernando A M S', 'Initials': 'FAMS', 'LastName': 'Figueira', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Flávia C S', 'Initials': 'FCS', 'LastName': 'Kojima', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Damiani', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Renato H N', 'Initials': 'RHN', 'LastName': 'Santos', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Nanci', 'Initials': 'N', 'LastName': 'Valeis', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Viviane B', 'Initials': 'VB', 'LastName': 'Campos', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Jose F K', 'Initials': 'JFK', 'LastName': 'Saraiva', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Francisco H', 'Initials': 'FH', 'LastName': 'Fonseca', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Ibraim M', 'Initials': 'IM', 'LastName': 'Pinto', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Carlos C', 'Initials': 'CC', 'LastName': 'Magalhães', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Joao F M', 'Initials': 'JFM', 'LastName': 'Ferreira', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pavanello', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'From the HCor Research Institute (H.P.G., P.G.M.B.S., F.C.S.K., L.D., R.H.N.S., N.V., V.B.C., R.P., A.B.C., O.B.), Instituto Dante Pazzanese de Cardiologia (I.L.L.), Instituto do Coração do Hospital das Clínicas\xa0da Faculdade de Medicina da Universidade de São Paulo (R.O.S., F.T.), Sociedade de Cardiologia do Estado de São Paulo (J.F.K.S., F.H.F., I.M.P., C.C.M., J.F.M.F., R.P., O.B.), and Hospital Israelita Albert Einstein (O.B.), São Paulo, Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.-F.), Hospital Metropolitano Sul Dom Helder Câmara, Cabo de Santo Agostinho (R.L.S.P.), Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre (T.L.L.L.), Pronto Socorro Cardiológico Prof. Luiz Tavares, Procape (D.L.), Instituto de Medicina Integral Prof. Fernando Figueira (F.A.M.S.F.), Recife, Sociedade Hospitalar Angelina Caron, Campina Grande do Sul (D.B.P.), Instituto de Cardiologia do Distrito Federal, Brasília (F.A.A.), Centro de Pesquisa Clínica do Coração, Aracajú (F.S.S.), Quanta Diagnóstico e Terapia, Curitiba (F.R.F.), Hospital Evangélico de Vila Velha, Vila Velha (D.O.B.), Unidade Médico Cirúrgica-Unimec, Vitória da Conquista (A.P.A.), Hospital de Caridade São Vicente de Paulo, Jundiaí (A.C.Z.), Hospital de Messejana Dr. Carlos Alberto Studart Gomes, Fortaleza (J.D.S.N.), Hospital Regional de Presidente Prudente-Universidade do Oeste Paulista, Presidente Prudente (M.A.C.), and Instituto de Pesquisa Clínica de Campinas, Campinas (J.F.K.S.) - all in Brazil; and Duke Clinical Research Institute, Duke Health, Durham, NC (R.D.L., J.H.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2029603']
1552,33217600,Application of thrombin gel matrix for the prevention of lymphocele in patients with endometrial cancer: A prospective randomized trial.,"OBJECTIVE
To evaluate a thrombin gel matrix (TGM), Floseal, for the prevention of lymphocele in patients with endometrial cancer who underwent pelvic lymphadenectomy.
METHODS
A total of 79 consecutive patients with endometrial cancer were randomly allocated to one of two groups: the TGM group and control group. After completion of the lymphadenectomy, 5 mL of Floseal was applied to the bilateral pelvic sidewalls, especially the femoral canal, obturator, and common iliac vessels areas. Computed tomography scans were obtained for lymphocele evaluation 2 months after the surgery.
RESULTS
Three patients from the TGM group, and four patients from the control group were lost during follow-up, and data from 36 participants from each group were analyzed. As the primary outcome, lymphocele developed in 12 patients in both groups (33 %). There was no significant difference between the groups in terms of lymphocele and symptomatic lymphocele development. Lymphocele localization was also not different between the two groups, but the diameter of the lymphoceles detected in the TGM group was significantly greater (p = 0.021). The mean drainage days was significantly shorter in the TGM group (p = 0.015). The amount of drainage was also less in the TGM group, but the difference was not statistically significant.
CONCLUSION
Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer. However, it can reduce the amount of drainage and the number of drainage days so it can help to shorten hospitalization.",2020,"CONCLUSION
Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer.","['patients with endometrial cancer who underwent pelvic lymphadenectomy', '79 consecutive patients with endometrial cancer', 'patients with endometrial cancer']","['TGM group and control group', 'thrombin gel matrix', 'Thrombin gel matrix', 'TGM', 'thrombin gel matrix (TGM), Floseal', 'lymphadenectomy, 5\u2009mL of Floseal']","['mean drainage days', 'Lymphocele localization', 'incidence of symptomatic or asymptomatic lymphoceles', 'amount of drainage', 'lymphocele and symptomatic lymphocele development', 'lymphocele']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}]","[{'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",79.0,0.0301364,"CONCLUSION
Thrombin gel matrix applied to the pelvic sidewalls does not reduce the incidence of symptomatic or asymptomatic lymphoceles after pelvic lymphadenectomy in endometrial cancer.","[{'ForeName': 'Şener', 'Initials': 'Ş', 'LastName': 'Gezer', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey. Electronic address: dr.senergezer@gmail.com.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Pulur', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey.'}, {'ForeName': 'İzzet', 'Initials': 'İ', 'LastName': 'Yücesoy', 'Affiliation': 'Kocaeli University School of Medicine, Department of Gynecologic Oncology, Turkey.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101994']
1553,33217697,Joint fatigue-failure: A demonstration of viscoelastic responses to rate and frequency loading parameters using the porcine cervical spine.,"Fatigue-failure in low back tissues is influenced by parameters of cyclic loading. Therefore, this study quantified the effect of loading rate and frequency on the number of tolerated compression cycles. Energy storage and vertical deformation were secondarily examined. Thirty-two porcine spinal units were randomly assigned to experimental groups that differed by loading rate (4.2 kN/s, 8.3 kN/s) and loading frequency (0.5 Hz, 1 Hz). Following preload and range-of-motion tests, specimens were cyclically loaded in a neutral posture until fatigue-failure occurred or 10800 cycles were tolerated. Macroscopic dissection was performed to identify the fracture morphology, and measurements of energy storage and vertical displacement were calculated throughout the specimen lifespan (1%, 10%, 50%, 90%, 99%). Given the differences in compression dose-force-time integral-between experimental conditions, the number of sustained cycles were assessed following linear and nonlinear dose-normalization via correction factors calculated from existing risk-exposure approximations. Without dose-normalization, an 8.3 kN/s loading rate and 0.5 Hz loading frequency reduced the fatigue lifetime by 3541 and 5977 cycles, respectively (p < 0.001). Linear and nonlinear dose-normalization resulted in a significant rate × frequency interaction (p < 0.001). For a 1 Hz loading frequency, the number of sustained loading cycles did not differ between loading rates (p adj ≥ 0.988), but at 0.5 Hz, spinal units compressed at 8.3 kN/s sustained 99% (linear) and 97% (nonlinear) fewer cycles (p adj < 0.001). These findings demonstrate that the interacting effects of loading frequency and loading rate on spinal fatigue-failure depend on the normalization of dose discrepancies between experimental groups.",2020,"For a 1 Hz loading frequency, the number of sustained loading cycles did not differ between loading rates (p adj ≥ 0.988), but at 0.5 Hz, spinal units compressed at 8.3 kN/s sustained 99% (linear) and 97% (nonlinear) fewer cycles (p adj < 0.001).","['Joint fatigue-failure', 'Thirty-two porcine spinal units', 'porcine cervical spine']",[],"['number of sustained loading cycles', 'Energy storage and vertical deformation', 'fatigue lifetime', 'loading frequency', 'Fatigue-failure', 'loading rate']","[{'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",,0.0317484,"For a 1 Hz loading frequency, the number of sustained loading cycles did not differ between loading rates (p adj ≥ 0.988), but at 0.5 Hz, spinal units compressed at 8.3 kN/s sustained 99% (linear) and 97% (nonlinear) fewer cycles (p adj < 0.001).","[{'ForeName': 'Jackie D', 'Initials': 'JD', 'LastName': 'Zehr', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Jessa M', 'Initials': 'JM', 'LastName': 'Buchman-Pearle', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Jack P', 'Initials': 'JP', 'LastName': 'Callaghan', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada. Electronic address: jack.callaghan@uwaterloo.ca.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2020.110081']
1554,33190679,Levetiracetam as an alternative to phenytoin for second-line emergency treatment of children with convulsive status epilepticus: the EcLiPSE RCT.,"BACKGROUND
Convulsive status epilepticus is the most common neurological emergency in children. Its management is important to avoid or minimise neurological morbidity and death. The current first-choice second-line drug is phenytoin (Epanutin, Pfizer Inc., New York, NY, USA), for which there is no robust scientific evidence.
OBJECTIVE
To determine whether phenytoin or levetiracetam (Keppra, UCB Pharma, Brussels, Belgium) is the more clinically effective intravenous second-line treatment of paediatric convulsive status epilepticus and to help better inform its management.
DESIGN
A multicentre parallel-group randomised open-label superiority trial with a nested mixed-method study to assess recruitment and research without prior consent.
SETTING
Participants were recruited from 30 paediatric emergency departments in the UK.
PARTICIPANTS
Participants aged 6 months to 17 years 11 months, who were presenting with convulsive status epilepticus and were failing to respond to first-line treatment.
INTERVENTIONS
Intravenous levetiracetam (40 mg/kg) or intravenous phenytoin (20 mg/kg).
MAIN OUTCOME MEASURES
Primary outcome - time from randomisation to cessation of all visible signs of convulsive status epilepticus. Secondary outcomes - further anticonvulsants to manage the convulsive status epilepticus after the initial agent, the need for rapid sequence induction owing to ongoing convulsive status epilepticus, admission to critical care and serious adverse reactions.
RESULTS
Between 17 July 2015 and 7 April 2018, 286 participants were randomised, treated and consented. A total of 152 participants were allocated to receive levetiracetam and 134 participants to receive phenytoin. Convulsive status epilepticus was terminated in 106 (70%) participants who were allocated to levetiracetam and 86 (64%) participants who were allocated to phenytoin. Median time from randomisation to convulsive status epilepticus cessation was 35 (interquartile range 20-not assessable) minutes in the levetiracetam group and 45 (interquartile range 24-not assessable) minutes in the phenytoin group (hazard ratio 1.20, 95% confidence interval 0.91 to 1.60; p = 0.2). Results were robust to prespecified sensitivity analyses, including time from treatment commencement to convulsive status epilepticus termination and competing risks. One phenytoin-treated participant experienced serious adverse reactions.
LIMITATIONS
First, this was an open-label trial. A blinded design was considered too complex, in part because of the markedly different infusion rates of the two drugs. Second, there was subjectivity in the assessment of 'cessation of all signs of continuous, rhythmic clonic activity' as the primary outcome, rather than fixed time points to assess convulsive status epilepticus termination. However, site training included simulated demonstration of seizure cessation. Third, the time point of randomisation resulted in convulsive status epilepticus termination prior to administration of trial treatment in some cases. This affected both treatment arms equally and had been prespecified at the design stage. Last, safety measures were a secondary outcome, but the trial was not powered to demonstrate difference in serious adverse reactions between treatment groups.
CONCLUSIONS
Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions. The results suggest that it may be an alternative to phenytoin in the second-line management of paediatric convulsive status epilepticus. Simple trial design, bespoke site training and effective leadership were found to facilitate practitioner commitment to the trial and its success. We provide a framework to optimise recruitment discussions in paediatric emergency medicine trials.
FUTURE WORK
Future work should include a meta-analysis of published studies and the possible sequential use of levetiracetam and phenytoin or sodium valproate in the second-line treatment of paediatric convulsive status epilepticus.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN22567894 and European Clinical Trials Database EudraCT number 2014-002188-13.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 58. See the NIHR Journals Library website for further project information.",2020,"CONCLUSIONS
Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions.","['Participants were recruited from 30 paediatric emergency departments in the UK', 'and 134 participants to receive', 'Between 17 July 2015 and 7 April 2018, 286 participants were randomised, treated and consented', 'Convulsive status epilepticus was terminated in 106 (70%) participants who were allocated to levetiracetam and 86 (64%) participants who were allocated to', 'Participants aged 6 months to 17 years 11 months, who were presenting with convulsive status epilepticus and were failing to respond to first-line treatment', 'A total of 152 participants', 'children', 'children with convulsive status epilepticus']","['intravenous phenytoin', 'Levetiracetam', 'Intravenous levetiracetam', 'levetiracetam and phenytoin or sodium valproate', 'levetiracetam', 'phenytoin or levetiracetam (Keppra, UCB Pharma, Brussels, Belgium', 'phenytoin']","[' time from randomisation to cessation of all visible signs of convulsive status epilepticus', 'convulsive status epilepticus, admission to critical care and serious adverse reactions', 'convulsive status epilepticus termination', 'convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions', 'serious adverse reactions', 'Median time from randomisation to convulsive status epilepticus cessation']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0031507', 'cui_str': 'Phenytoin'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}, {'cui': 'C0876060', 'cui_str': 'Keppra'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0311335', 'cui_str': 'Grand mal status'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",152.0,0.189183,"CONCLUSIONS
Levetiracetam was not statistically superior to phenytoin in convulsive status epilepticus termination rate, time taken to terminate convulsive status epilepticus or frequency of serious adverse reactions.","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Appleton', 'Affiliation': ""The Roald Dahl Neurophysiology Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Naomi Ea', 'Initials': 'NE', 'LastName': 'Rainford', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shrouk', 'Initials': 'S', 'LastName': 'Messahel', 'Affiliation': ""Emergency Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Humphreys', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hickey', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Woolfall', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Roper', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Noblet', 'Affiliation': ""Emergency Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lee', 'Affiliation': ""Emergency Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Potter', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Tate', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Al Najjar', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Iyer', 'Affiliation': ""The Roald Dahl Neurophysiology Department, Alder Hey Children's Hospital, Liverpool, UK.""}, {'ForeName': 'Vicki', 'Initials': 'V', 'LastName': 'Evans', 'Affiliation': 'Patient and public involvement representative, Wrexham, UK.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Lyttle', 'Affiliation': 'Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24580']
1555,33191846,Cardiotoxicity and Cardiovascular Biomarkers in Patients With Breast Cancer: Data From the GeparOcto-GBG 84 Trial.,"Background Patients with breast cancer can be affected by cardiotoxic reactions through cancer therapies. Cardiac biomarkers, like NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity cardiac troponin T, might have predictive value. Methods and Results Echocardiography, ECG, hemodynamic parameters, NT-proBNP and high-sensitivity cardiac troponin T were assessed in 853 patients with early-stage breast cancer randomized in the German Breast Group GeparOcto-GBG 84 phase III trial. Patients received neo-adjuvant dose-dense, dose-intensified epirubicin, paclitaxel, and cyclophosphamide (iddEPC group, n=424) or paclitaxel, non-pegylated doxorubicin, and in triple negative breast cancer, (paclitaxel, non-pegylated doxorubicin, carboplatin group, n=429) treatment for 18 weeks. Patients positive for human epidermal growth receptor 2 (n=354, 41.5%) received monoclonal antibodies on top of allocated therapy; 119 (12.9%) of all patients showed a cardiotoxic reaction during therapy (15 [1.8%] using a more strict definition). Presence of cardiotoxic reactions was irrespective of treatment allocation ( P =0.31). Small but significant increases in NT-proBNP developed early in patients with a cardiotoxic reaction as compared with those without in whom NT-proBNP rose only towards the end of therapy ( P =0.04). High-sensitivity cardiac troponin T rose early in both groups. Logistic regression showed that NT-proBNP (odds ratio [OR], 1.03; 95% CI, 1.008-1.055; P =0.01) and hemoglobin (OR, 1.31; 95% CI, 1.05-1.63; P =0.02) measured at 6 weeks after treatment initiation were significantly associated with cardiotoxic reactions. Conclusions NT-proBNP and hemoglobin are significantly associated with cardiotoxic reactions in patients with early-stage breast cancer undergoing dose-dense and dose-intensified chemotherapy, but high-sensitivity cardiac troponin T is not. Registration URL: http://www.clinicaltrials.gov; Unique identifier: NCT02125344.",2020,Small but significant increases in NT-proBNP developed early in patients with a cardiotoxic reaction as compared with those without in whom NT-proBNP rose only towards the end of therapy ( P =0.04).,"['patients with early-stage breast cancer', ' Patients with breast cancer', 'Patients With Breast Cancer', '853 patients with early-stage breast cancer randomized in the German Breast Group GeparOcto-GBG 84 phase III trial']","['neo-adjuvant dose-dense, dose-intensified epirubicin, paclitaxel, and cyclophosphamide (iddEPC group, n=424) or paclitaxel, non-pegylated doxorubicin, and in triple negative breast cancer, (paclitaxel, non-pegylated doxorubicin, carboplatin']","['Echocardiography, ECG, hemodynamic parameters, NT-proBNP and high-sensitivity cardiac troponin T', 'cardiotoxic reaction', 'monoclonal antibodies', 'NT-proBNP', 'cardiotoxic reactions', 'hemoglobin ', 'Cardiotoxicity and Cardiovascular Biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0523953', 'cui_str': 'Troponin T cardiac measurement'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",853.0,0.136134,Small but significant increases in NT-proBNP developed early in patients with a cardiotoxic reaction as compared with those without in whom NT-proBNP rose only towards the end of therapy ( P =0.04).,"[{'ForeName': 'Alexandra Maria', 'Initials': 'AM', 'LastName': 'Rüger', 'Affiliation': 'Department of Cardiology Charité - Universitätsmedizin BerlinBerlin, Campus Virchow-Klinikum Berlin Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases University Hospital and German Cancer Research Center Heidelberg Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Seiler', 'Affiliation': 'German Breast GroupNeu-Isenburg and Center for Hematology and Oncology Bethanien Frankfurt Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Praxis Bethanien Frankfurt Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'University Hospital Schleswig-Holstein Kiel Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Department of Gynecologic Oncology Medical Faculty Mannheim Heidelberg UniversityUniversity Hospital Mannheim Mannheim Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lübbe', 'Affiliation': 'Diakovere Henriettenstift Hannover Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Sinn', 'Affiliation': 'Charité Universitätsmedizin Berlin Berlin Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University Hospital Frankfurt Frankfurt Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'University Hospital RWTH Aachen Aachen Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology University Medical Center Hamburg Eppendorf Hamburg Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum Hamburg Hamburg Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital Marburg Marburg Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen Nuremberg Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast GroupNeu-Isenburg and Center for Hematology and Oncology Bethanien Frankfurt Germany.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Garfias-Macedo', 'Affiliation': 'Department of Cardiology and Pneumology University of Göttingen Medical Center Göttingen Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Hasenfuß', 'Affiliation': 'Department of Cardiology and Pneumology University of Göttingen Medical Center Göttingen Germany.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Cardiology Charité - Universitätsmedizin BerlinBerlin, Campus Virchow-Klinikum Berlin Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast GroupNeu-Isenburg and Center for Hematology and Oncology Bethanien Frankfurt Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'Department of Cardiology and Pneumology University of Göttingen Medical Center Göttingen Germany.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.018143']
1556,33199596,Thymus-derived B cell clones persist in the circulation after thymectomy in myasthenia gravis.,"Myasthenia gravis (MG) is a neuromuscular, autoimmune disease caused by autoantibodies that target postsynaptic proteins, primarily the acetylcholine receptor (AChR) and inhibit signaling at the neuromuscular junction. The majority of patients under 50 y with AChR autoantibody MG have thymic lymphofollicular hyperplasia. The MG thymus is a reservoir of plasma cells that secrete disease-causing AChR autoantibodies and although thymectomy improves clinical scores, many patients fail to achieve complete stable remission without additional immunosuppressive treatments. We speculate that thymus-associated B cells and plasma cells persist in the circulation after thymectomy and that their persistence could explain incomplete responses to resection. We studied patients enrolled in a randomized clinical trial and used complementary modalities of B cell repertoire sequencing to characterize the thymus B cell repertoire and identify B cell clones that resided in the thymus and circulation before and 12 mo after thymectomy. Thymus-associated B cell clones were detected in the circulation by both mRNA-based and genomic DNA-based sequencing. These antigen-experienced B cells persisted in the circulation after thymectomy. Many circulating thymus-associated B cell clones were inferred to have originated and initially matured in the thymus before emigration from the thymus to the circulation. The persistence of thymus-associated B cells correlated with less favorable changes in clinical symptom measures, steroid dose required to manage symptoms, and marginal changes in AChR autoantibody titer. This investigation indicates that the diminished clinical response to thymectomy is related to persistent circulating thymus-associated B cell clones.",2020,"The persistence of thymus-associated B cells correlated with less favorable changes in clinical symptom measures, steroid dose required to manage symptoms, and marginal changes in AChR autoantibody titer.",['myasthenia gravis'],[],['Thymus-associated B cell clones'],"[{'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}]",[],"[{'cui': 'C0040112', 'cui_str': 'Thymus Extracts'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0009013', 'cui_str': 'Clone'}]",,0.0236695,"The persistence of thymus-associated B cells correlated with less favorable changes in clinical symptom measures, steroid dose required to manage symptoms, and marginal changes in AChR autoantibody titer.","[{'ForeName': 'Ruoyi', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Hoehn', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Casey S', 'Initials': 'CS', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Minh C', 'Initials': 'MC', 'LastName': 'Pham', 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Homer', 'Affiliation': 'Department of Pathology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Detterbeck', 'Affiliation': 'Department of Surgery, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Aban', 'Affiliation': 'Department of Biostatistics, University of Alabama, Birmingham, AL 35294.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Jacobson', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, OX1 2JD Oxford, United Kingdom.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, University of Oxford, OX1 2JD Oxford, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Nowak', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, New Haven, CT 06511.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'Department of Neurology, The George Washington University, Washington, DC 20052.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Kleinstein', 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511; steven.kleinstein@yale.edu kevin.oconnor@yale.edu.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Immunobiology, Yale University School of Medicine, New Haven, CT 06511; steven.kleinstein@yale.edu kevin.oconnor@yale.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2007206117']
1557,33200413,Smartphone-Delivered Progressive Muscle Relaxation for the Treatment of Migraine in Primary Care: A Randomized Controlled Trial.,"OBJECTIVE
Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting.
METHODS
This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days.
RESULTS
Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2-4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
CONCLUSION
Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.",2020,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
","['Eligible participants spoke English and owned a smartphone', 'adults with migraine and 4+ headache days/month', '139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7\xa0±\xa012.8 years', 'Migraine in Primary Care']","['RELAXaHEAD', 'Smartphone-Delivered Progressive Muscle Relaxation', 'PMR and the other without PMR', 'progressive muscle relaxation (PMR) delivered by a smartphone application (app']","['disability scores', 'moderate-severe disability', 'feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels', 'mean MIDAS scores', 'Migraine Disability Assessment Scale (MIDAS) scores']","[{'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517547', 'cui_str': '12.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}]",139.0,0.0933415,"Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38).
","[{'ForeName': 'Mia T', 'Initials': 'MT', 'LastName': 'Minen', 'Affiliation': 'Department of Neurology, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Samrachana', 'Initials': 'S', 'LastName': 'Adhikari', 'Affiliation': 'Department of Population Health, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Padikkala', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Sumaiya', 'Initials': 'S', 'LastName': 'Tasneem', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Bagheri', 'Affiliation': 'Center for Healthcare Innovation and Delivery Science, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine Faculty Group Practices, NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Powers', 'Affiliation': ""Behavioral Medicine, Headache Medicine, Clinical Psychology, Cincinnati Children's Hospital, Cincinnati, OH, USA.""}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Montefiore Headache Center, Department of Neurology, Albert Einstein College of Medicine, New York, NY, USA.'}]",Headache,['10.1111/head.14010']
1558,33200990,Web-Based Relaxation Intervention for Stress During Social Isolation: Randomized Controlled Trial.,"BACKGROUND
Relaxation practices might be helpful exercises for coping with anxiety and stressful sensations. They may be of particular utility when used in web-based interventions during periods of social isolation.
OBJECTIVE
This randomized study aimed to test whether web-based relaxation practices like natural sounds, deep respiration, and body scans can promote relaxation and a positive emotional state, and reduce psychomotor activation and preoccupation related to the COVID-19 pandemic.
METHODS
Participants were randomly assigned to one of three experimental conditions. Each condition was characterized by a single online session of a guided square breathing exercise, a guided body scan exercise, or natural sounds. The participants listened to one of the fully automated audio clips for 7 minutes and pre-post completed self-assessed scales on perceived relaxation, psychomotor activation, level of preoccupation associated with COVID-19, and emotional state. At the end of the session, qualitative reports on subjective experience were also collected.
RESULTS
Overall, 294 participants completed 75% of the survey and 240 completed the entire survey as well as one of three randomly assigned interventions. Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19 showed a positive improvement after participants listened to the audio clips. The same pattern was observed for the valence and perceived dominance of the emotional state. The square breathing and body scan exercises yielded superior results compared to natural sounds in lowering perceived stress.
CONCLUSIONS
This study provides a novel insight that can guide the development of future low-cost web-based interventions to reduce preoccupation and stress in the general population.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/19236.",2020,"Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19 showed a positive improvement after the audio clips.","['Participants', '294 participants completed 75% of the survey and 240 completed the entire survey as well as one of three randomly assigned interventions']","['A web-based relaxation interventions', 'guided Square Breathing exercise, guided Body Scan exercise, or Natural Sounds', 'web-based relaxation practices like natural sounds, deep respiration, and body scan']","['Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19', 'relaxation, psychomotor activation, level of preoccupation associated with COVID-19, and emotional state']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}]",294.0,0.055817,"Perceived relaxation, psychomotor activation/stress, and preoccupation related to COVID-19 showed a positive improvement after the audio clips.","[{'ForeName': 'Silvia Francesca Maria', 'Initials': 'SFM', 'LastName': 'Pizzoli', 'Affiliation': 'University of Milan, Department of Oncology and Hematology-Oncology, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Marzorati', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology IEO, IRCCS, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Mazzoni', 'Affiliation': 'University of Milan, Department of Oncology and Hematology-Oncology, Milan, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'University of Milan, Department of Oncology and Hematology-Oncology, Milan, Italy.'}]",JMIR mental health,['10.2196/22757']
1559,33201535,"A Pilot Randomized, Controlled, Double-Blind Trial of Bumetanide to Treat Neonatal Seizures.","OBJECTIVE
In the absence of controlled trials, treatment of neonatal seizures has changed minimally despite poor drug efficacy. We tested bumetanide added to phenobarbital to treat neonatal seizures in the first trial to include a standard-therapy control group.
METHODS
A randomized, double-blind, dose-escalation design was employed. Neonates with postmenstrual age 33 to 44 weeks at risk of or with seizures were eligible. Subjects with electroencephalography (EEG)-confirmed seizures after ≥20 and <40mg/kg phenobarbital were randomized to receive additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide (treatment). Continuous EEG monitoring data from ≥2 hours before to ≥48 hours after study drug administration (SDA) were analyzed for seizures.
RESULTS
Subjects were randomized to treatment (n = 27) and control (n = 16) groups. Pharmacokinetics were highly variable among subjects and altered by hypothermia. The only statistically significant adverse event was diuresis in treated subjects (48% vs 13%, p = 0.02). One treated (4%) and 3 control subjects died (19%, p = 0.14). Among survivors, 2 of 26 treated subjects (8%) and 0 of 13 control subjects had hearing impairment, as did 1 nonrandomized subject. Total seizure burden varied widely, with much higher seizure burden in treatment versus control groups (median = 3.1 vs 1.2 min/h, p = 0.006). There was significantly greater reduction in seizure burden 0 to 4 hours and 2 to 4 hours post-SDA (both p < 0.01) compared with 2-hour baseline in treatment versus control groups with adjustment for seizure burden.
INTERPRETATION
Although definitive proof of efficacy awaits an appropriately powered phase 3 trial, this randomized, controlled, multicenter trial demonstrated an additional reduction in seizure burden attributable to bumetanide over phenobarbital without increased serious adverse effects. Future trials of bumetanide and other drugs should include a control group and balance seizure severity. ANN NEUROL 2020.",2020,"There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden.
","['Subjects with EEG-confirmed seizures after ≥20 and <40mg/kg phenobarbital', 'neonatal seizures', 'Subjects were randomized to treatment (n=27) and control (n=16) groups', 'Neonates with postmenstrual age 33-44weeks at risk of or with seizures were eligible']","['phenobarbital', 'additional phenobarbital with either placebo (control) or 0.1, 0.2, or 0.3mg/kg bumetanide', 'bumetanide']","['Total seizure burden', 'adverse event was diuresis', 'seizure burden', 'hearing impairment']","[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0159020', 'cui_str': 'Convulsions in the newborn'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0031412', 'cui_str': 'Phenobarbital'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0006376', 'cui_str': 'Bumetanide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.392446,"There was significantly greater reduction in seizure burden 0-4 hours and 2-4 hours post-SDA (both P<0.01) compared with 2-hour baseline in treatment vs. control groups with adjustment for seizure burden.
","[{'ForeName': 'Janet S', 'Initials': 'JS', 'LastName': 'Soul', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Bergin', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stopp', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Breda', 'Initials': 'B', 'LastName': 'Hayes', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Avantika', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Carmen R', 'Initials': 'CR', 'LastName': 'Fortuno', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': ""O'Reilly"", 'Affiliation': ""Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kalpathy', 'Initials': 'K', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Frances E', 'Initials': 'FE', 'LastName': 'Jensen', 'Affiliation': ""Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Rofeberg', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vinks', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Staley', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25959']
1560,33196464,Kisspeptin receptor agonist has therapeutic potential for female reproductive disorders.,"BACKGROUNDKisspeptin is a key regulator of hypothalamic gonadotropin-releasing hormone (GnRH) neurons and is essential for reproductive health. A specific kisspeptin receptor (KISS1R) agonist could significantly expand the potential clinical utility of therapeutics targeting the kisspeptin pathway. Herein, we investigate the effects of a KISS1R agonist, MVT-602, in healthy women and in women with reproductive disorders.METHODSWe conducted in vivo and in vitro studies to characterize the action of MVT-602 in comparison with native kisspeptin-54 (KP54). We determined the pharmacokinetic and pharmacodynamic properties of MVT-602 (doses 0.01 and 0.03 nmol/kg) versus KP54 (9.6 nmol/kg) in the follicular phase of healthy women (n = 9), and in women with polycystic ovary syndrome (PCOS; n = 6) or hypothalamic amenorrhea (HA; n = 6). Further, we investigated their effects on KISS1R-mediated inositol monophosphate (IP1) and Ca2+ signaling in cell lines and on action potential firing of GnRH neurons in brain slices.RESULTSIn healthy women, the amplitude of luteinizing hormone (LH) rise was similar to that after KP54, but peaked later (21.4 vs. 4.7 hours; P = 0.0002), with correspondingly increased AUC of LH exposure (169.0 vs. 38.5 IU∙h/L; P = 0.0058). LH increases following MVT-602 were similar in PCOS and healthy women, but advanced in HA (P = 0.004). In keeping with the clinical data, MVT-602 induced more potent signaling of KISS1R-mediated IP1 accumulation and a longer duration of GnRH neuron firing than KP54 (115 vs. 55 minutes; P = 0.0012).CONCLUSIONTaken together, these clinical and mechanistic data identify MVT-602 as having considerable therapeutic potential for the treatment of female reproductive disorders.TRIAL REGISTRATIONInternational Standard Randomised Controlled Trial Number (ISRCTN) Registry, ISRCTN21681316.FUNDINGNational Institute for Health Research and NIH.",2020,"LH increases following MVT-602 were similar in PCOS and healthy women, but advanced in HA (P = 0.004).","['healthy women and in women with reproductive disorders', 'healthy women (n = 9), and in women with polycystic ovary syndrome (PCOS; n = 6) or hypothalamic amenorrhea (HA; n = 6', 'healthy women', 'female reproductive disorders']","['MVT-602', 'Kisspeptin receptor agonist', 'native kisspeptin-54 (KP54', 'KISS1R agonist, MVT-602', 'KP54']","['LH increases following MVT-602', 'AUC of LH exposure', 'amplitude of luteinizing hormone (LH) rise']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0341862', 'cui_str': 'Hypothalamic amenorrhea'}, {'cui': 'C0236100', 'cui_str': 'Disorder of female reproductive system'}]","[{'cui': 'C0540309', 'cui_str': 'KISS1 protein, human'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C3146273', 'cui_str': 'Metastins'}, {'cui': 'C4318433', 'cui_str': 'Kisspeptin-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0520970', 'cui_str': 'Hormone increase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",,0.0570407,"LH increases following MVT-602 were similar in PCOS and healthy women, but advanced in HA (P = 0.004).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Pei Chia', 'Initials': 'PC', 'LastName': 'Eng', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Sophie A', 'Initials': 'SA', 'LastName': 'Clarke', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Richardson', 'Affiliation': 'Institute of Reproductive and Developmental Biology, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Charlene M', 'Initials': 'CM', 'LastName': 'Sykes', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Chayarndorn', 'Initials': 'C', 'LastName': 'Phumsatitpong', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Izzi-Engbeaya', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Purugganan', 'Affiliation': 'Hammersmith IVF unit, and.'}, {'ForeName': 'Channa N', 'Initials': 'CN', 'LastName': 'Jayasena', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': ""St Mary's Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom.""}, {'ForeName': 'Rehan', 'Initials': 'R', 'LastName': 'Salim', 'Affiliation': 'Hammersmith IVF unit, and.'}, {'ForeName': 'Bryn', 'Initials': 'B', 'LastName': 'Owen', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'McArdle', 'Affiliation': 'Department of Translational Medicine, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Margaritis', 'Initials': 'M', 'LastName': 'Voliotis', 'Affiliation': 'Department of Mathematics and Living Systems Institute, and.'}, {'ForeName': 'Krasimira', 'Initials': 'K', 'LastName': 'Tsaneva-Atanasova', 'Affiliation': 'Department of Mathematics and Living Systems Institute, and.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Moenter', 'Affiliation': 'Department of Molecular & Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Hanyaloglu', 'Affiliation': 'Institute of Reproductive and Developmental Biology, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, Hammersmith Hospital, London, United Kingdom.'}]",The Journal of clinical investigation,['10.1172/JCI139681']
1561,33196511,A pilot randomized trial of atorvastatin as adjunct therapy in patients with acute venous thromboembolism.,": Venous thromboembolism (VTE) is the third most common cardiovascular disease and optimizing treatment is essential. In this single-center pilot study, we sought to investigate the effects of statins in addition to anticoagulation in patients with acute VTE. We enrolled patients over 18 with an acute proximal lower extremity deep vein thrombosis with or without pulmonary embolism. Patients were randomized to anticoagulation alone (with either warfarin or rivaroxaban) or anticoagulation and atorvastatin 40 mg daily and followed for 9 months. The primary objective was to determine if adjunct atorvastatin reduced thrombin generation, measured by endogenous thrombin potential and/or peak thrombin concentration. Secondary endpoints included recurrent VTE, arterial thrombosis, bleeding events, lipidomic profiles, and symptoms of post thrombotic syndrome. A total of 21 patients were enrolled (11 anticoagulation only and 10 anticoagulation and atorvastatin) over 3.5 years. Endogenous thrombin potential or peak thrombin was not significantly recued with the addition of atorvastatin. Atorvastatin did significantly reduce the mean LDLs at 3 months, without reduction of either D-dimer or high-sensitivity-C reactive protein. Given the low recruitment rate, continuation of the study was deemed futile and the study was terminated early. Barriers to enrollment and completion of study included the many ineligible patients by exclusion criteria (e.g., preexisting statin use, active malignancy, etc.) and high rate of lost follow-up. The pilot study was terminated early but could inform obstacles for future studies investigating the effects of statins in the management of patients with VTE.",2020,"Atorvastatin did significantly reduce the mean LDLs at 3 months, without reduction of either D-dimer or high-sensitivity-C reactive protein.","['patients with acute venous thromboembolism', 'enrolled patients over 18 with an acute proximal lower extremity deep vein thrombosis with or without pulmonary embolism', 'many ineligible patients by exclusion criteria (e.g., preexisting statin use, active malignancy, etc.) and high rate of lost follow-up', 'patients with acute VTE', 'patients with VTE', '21 patients were enrolled (11 anticoagulation only and 10 anticoagulation and atorvastatin) over 3.5 years']","['statins', 'anticoagulation alone (with either warfarin or rivaroxaban) or anticoagulation and atorvastatin', 'Atorvastatin', 'atorvastatin']","['endogenous thrombin potential and/or peak thrombin concentration', 'mean LDLs', 'Endogenous thrombin potential or peak thrombin', 'recurrent VTE, arterial thrombosis, bleeding events, lipidomic profiles, and symptoms of post thrombotic syndrome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0277919', 'cui_str': 'Venous stasis syndrome'}]",21.0,0.046449,"Atorvastatin did significantly reduce the mean LDLs at 3 months, without reduction of either D-dimer or high-sensitivity-C reactive protein.","[{'ForeName': 'Tzu-Fei', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Amanda P', 'Initials': 'AP', 'LastName': 'Waller', 'Affiliation': ""Center for Clinical & Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital.""}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Lin', 'Affiliation': 'College of Food, Agriculture, and Environmental Sciences.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Center for Biostatistics, The Ohio State University.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Bartosic', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, The Ohio State University Wexner Medical Center.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Riedl', 'Affiliation': 'College of Food, Agriculture, and Environmental Sciences.'}, {'ForeName': 'Bryce A', 'Initials': 'BA', 'LastName': 'Kerlin', 'Affiliation': ""Center for Clinical & Translational Research, The Abigail Wexner Research Institute at Nationwide Children's Hospital.""}]",Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis,['10.1097/MBC.0000000000000968']
1562,33197570,Effect of Mind Sound Resonance Technique (MSRT - A yoga-based relaxation technique) on psychological variables and cognition in school children: A randomized controlled trial.,"OBJECTIVE
School children undergo stress, which could impact their psychological functions and cognitive abilities. Yoga practices have been found useful in enhancing psychological functions and performance. The current study was planned to evaluate a yoga-based relaxation technique's efficacy as an extracurricular activity on psychological state and cognitive function.
DESIGN AND SETTING
This study was a parallel-group randomized controlled trial conducted at a government school in south India.
PARTICIPANTS
Sixty students with age ranging between 14-16 years (mean age ± SD; 15.3 ± 0.71 years) satisfying the inclusion and exclusion criteria were randomized to experimental and control groups with an allocation ratio of 1:1.
INTERVENTION
Experimental group received Mind Sound Resonance Technique (MSRT), whereas the control group performed supine rest (SR) for two-weeks.
OUTCOME MEASURES
Participants were assessed with State trait anxiety inventory - short form, Mind Wandering Questionnaire, State Mindfulness Attention Awareness Scale, and Trail making task at baseline and post-intervention.
RESULTS
Experimental group showed a reduction in state anxiety and mind wandering with improvement in state mindfulness and performance in the Trail-making task compared to the control group.
CONCLUSION
Results of the current trial indicate the beneficial role of MSRT in enhancing psychological and cognitive functions in children. Further, large-scale trials are warranted to ascertain the usefulness of the technique.",2020,"RESULTS
Experimental group showed a reduction in state anxiety and mind wandering with improvement in state mindfulness and performance in the Trail-making task compared to the control group.
","['School children undergo stress', 'government school in south India', 'School Children', 'children', 'Sixty students with age ranging between 14-16 years (mean age\u2009±\u2009SD; 15.3\u2009±\u20090.71 years) satisfying the inclusion and exclusion criteria']","['MSRT', 'Experimental group received Mind Sound Resonance Technique (MSRT', 'control group performed supine rest (SR', 'Mind Sound Resonance Technique (MSRT - a Yoga-Based Relaxation Technique']","['state anxiety', 'state mindfulness and performance', 'Psychological Variables and Cognition', 'State trait anxiety inventory - short form, Mind Wandering Questionnaire, State Mindfulness Attention Awareness Scale, and Trail making task']","[{'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0035029', 'cui_str': 'Relaxation technique'}]","[{'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0233569', 'cui_str': 'Wandering'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}]",60.0,0.037303,"RESULTS
Experimental group showed a reduction in state anxiety and mind wandering with improvement in state mindfulness and performance in the Trail-making task compared to the control group.
","[{'ForeName': 'U S', 'Initials': 'US', 'LastName': 'Anusuya', 'Affiliation': 'Annai College of Naturopathy and Yoga Sciences, Anaikudi Road, Kovilachery, Kumbakonam, Tamil Nadu, India.'}, {'ForeName': 'Sriloy', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Center for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Apar Avinash', 'Initials': 'AA', 'LastName': 'Saoji', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India. Electronic address: aparsaoji@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102606']
1563,33197609,Evaluation of intervention components to maximize outcomes of behavioral obesity treatment delivered online: A factorial experiment following the multiphase optimization strategy framework.,"BACKGROUND
Behavioral lifestyle intervention (BLI) is recommended as a first-line treatment for obesity. While BLI has been adapted for online delivery to improve potential for dissemination while reducing costs and barriers to access, weight losses are typically inferior to gold standard treatment delivered in-person. It is therefore important to refine and optimize online BLI in order to improve the proportion of individuals who achieve a minimum clinically significant weight loss and mean weight loss.
STUDY DESIGN
Five experimental intervention components will be tested as adjuncts to an established 12-month online BLI: virtual reality for BLI skills training, interactive video feedback, tailored intervention to promote physical activity, skills for dysregulated eating, and social support combined with friendly competition. Following the Multiphase Optimization Strategy (MOST) framework, the components will first be refined and finalized during Preparation Phase pilot testing and then evaluated in a factorial experiment with 384 adults with overweight or obesity. A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components. Mediation analysis will be conducted to test hypothesized mechanisms of action and a moderator analysis will be conducted to understand for whom and under what circumstances the interventions are effective.
CONCLUSION
This study will provide important information about intervention strategies that are useful for improving outcomes of online BLI. The finalized treatment package will be suitable for testing in a future randomized trial in the MOST Evaluation Phase.",2020,A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components.,['384 adults with overweight or obesity'],"['BLI skills training, interactive video feedback, tailored intervention to promote physical activity, skills for dysregulated eating, and social support combined with friendly competition', 'behavioral obesity treatment delivered online', 'Behavioral lifestyle intervention (BLI']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]",[],384.0,0.0288169,A priori optimization criteria that balance efficacy and efficiency will be used to create a finalized treatment package that produces the best weight loss outcomes with the fewest intervention components.,"[{'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA. Electronic address: john_g_thomas@brown.edu.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Lillis', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Eric B', 'Initials': 'EB', 'LastName': 'Hekler', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego (UCSD), Center for Wireless and Population Health Systems, Qualcomm Institute at UCSD, 9500 Gilman Ave., San Diego, CA 92093, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Emerson', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Hallie M', 'Initials': 'HM', 'LastName': 'Espel-Huynh', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, 121 S Main St., Providence, RI 02903, USA.'}, {'ForeName': 'E Whitney', 'Initials': 'EW', 'LastName': 'Evans', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Meghan L', 'Initials': 'ML', 'LastName': 'Butryn', 'Affiliation': 'Department of Psychology, Drexel University, 3141 Chestnut St, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Computer Science, Brown University, 115 Waterman St., Providence, RI 02906, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106217']
1564,33197610,Development of a mindfulness-based treatment for smoking cessation and the modification of alcohol use: A protocol for a randomized controlled trial and pilot study findings.,"The combined use of cigarettes and alcohol is associated with an increased risk of morbidity and mortality. Yet, efficacious interventions that address both behaviors concurrently are lacking. Smoking cessation and alcohol modification not only garner health benefits, but there is also value in addressing alcohol use in the context of smoking cessation to reduce the risk for smoking relapse. In this paper we describe the development of mindfulness-based relapse prevention for smoking cessation and alcohol modification (MBRP-SA) and pilot study findings (Phase 1). Next, details regarding the methods and design of an ongoing, randomized controlled trial, Project RISE (Phase 2), are described. MBRP-SA is a group-based intervention that consists of eight weekly treatment sessions. Results from the Phase 1 pilot study (N = 21 enrolled) indicated that participants planned to use the skills learned in their everyday activities and to address their smoking and alcohol goals. Based on the progression of Phase 1 cohorts, modifications were made to the inclusion/exclusion criteria and recruitment methods that will be implemented in Phase 2. Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.",2020,"Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.",[],['MBRP-SA'],['risk of morbidity and mortality'],[],[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",21.0,0.019142,"Phase 2 will assess the feasibility and acceptability of MBRP-SA, delivered via live online groups, as a primary treatment option for smoking cessation and alcohol use modification.","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Hemenway', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'University of New Mexico, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Unrod', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center, USA.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wetter', 'Affiliation': 'University of Utah, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': 'Moffitt Cancer Center, USA; University of South Florida, USA. Electronic address: christine.vinci@moffitt.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106218']
1565,33197648,Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom).,"BACKGROUND
The gains in walking capacity achieved during rehabilitation often plateau, or are lost, when the patient returns home. Moreover, maintaining or increasing the patient's daily physical activity level after a stroke remains challenging. We aimed to evaluate the effectiveness of a six-month individualized coaching program at home on walking capacity, as evaluated by the six-minute walk test in subacute stroke patients.
METHODS
Stroke patients in the physical medicine and rehabilitation service participated in a monocentric observer blinded randomized controlled trial with two groups, intervention versus usual care control. The inclusion criteria were: age≥18 years, first ischemic or hemorrhagic stroke, and stroke within<6 months. Participants were randomly assigned (blocks of variable size) to an intervention group (EG) receiving individualized coaching on physical activity, or to a control group (CG) receiving standard care. The six-month program was composed of monitored physical activity, home visits and a weekly phone call. Participants were evaluated after hospital discharge (T0), at the end of the six-month program (T1) and six months later(follow-up; T2). The primary outcome was the walking distance performance, as evaluated with the six-minute walk test at T1.
RESULTS
Eighty-three participants (age: 61y [IQR=22]; time post-stroke: 2.4 month [IQR=1.7]; Barthel index: 100[IQR=5]) were included in the study: (EG, n=41; CG, n=42). The difference between the two groups was not significant at T1(418m [IQR=165] for the EG and 389m [IQR=188] for the CG; P=0.168) and at T2(425m [IQR=121] for the EG vs. 382m [IQR=219] for the CG; P=0.208).
CONCLUSION
Our study shows no difference in the six-minute walk test between the two groups of subacute stroke patients after 6 months of the individualized coaching program, combining home visits, feedback on daily performance and weekly telephone calls. http://ClinicalTrials.gov (NCT01822938).",2020,The difference between the two groups was not significant at T1(418m [IQR=165] for the EG and 389m [IQR=188] for the CG; p=0.168) and at T2(425m,"['subacute stroke patients', 'Stroke patients in the physical medicine and rehabilitation service participated', 'The inclusion criteria were: age ≥18 years, first ischemic or hemorrhagic stroke, and stroke within <6 months', 'Eighty-three participants (age: 61y [IQR=22]; time post-stroke: 2.4 month [IQR=1.7]; Barthel index: 100[IQR=5]) were included in the study: (EG, n=41; CG, n=42']","['individualized coaching', 'individualized coaching on physical activity, or to a control group(CG) receiving standard care', 'intervention versus usual care control', 'six-month individualized coaching program']","['walking capacity', ""patient's daily physical activity level"", 'walking distance performance, as evaluated with the six-minute walk test at T1']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4302556', 'cui_str': 'Physical medicine and rehabilitation service'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",,0.0863257,The difference between the two groups was not significant at T1(418m [IQR=165] for the EG and 389m [IQR=188] for the CG; p=0.168) and at T2(425m,"[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Mandigout', 'Affiliation': 'Limoges university, HAVAE laboratory, EA 6310, 123, avenue Albert-Thomas, 87060 Limoges, France. Electronic address: stephane.mandigout@unilim.fr.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chaparro', 'Affiliation': 'Limoges university, HAVAE laboratory, EA 6310, 123, avenue Albert-Thomas, 87060 Limoges, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Borel', 'Affiliation': 'Limoges university, HAVAE laboratory, EA 6310, 123, avenue Albert-Thomas, 87060 Limoges, France.'}, {'ForeName': 'Kamoun', 'Initials': 'K', 'LastName': 'Benjamin', 'Affiliation': 'Limoges university, HAVAE laboratory, EA 6310, 123, avenue Albert-Thomas, 87060 Limoges, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Salle', 'Affiliation': 'Limoges university, HAVAE laboratory, EA 6310, 123, avenue Albert-Thomas, 87060 Limoges, France; Department of Medicine and physical rehabilitation service, Limoges university hospital, 87000 Limoges, France.'}, {'ForeName': 'Maxence', 'Initials': 'M', 'LastName': 'Compagnat', 'Affiliation': 'Limoges university, HAVAE laboratory, EA 6310, 123, avenue Albert-Thomas, 87060 Limoges, France; Department of Medicine and physical rehabilitation service, Limoges university hospital, 87000 Limoges, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Daviet', 'Affiliation': 'Limoges university, HAVAE laboratory, EA 6310, 123, avenue Albert-Thomas, 87060 Limoges, France; Department of Medicine and physical rehabilitation service, Limoges university hospital, 87000 Limoges, France.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.11.001']
1566,33197654,No effect of anodal tDCS on motor cortical excitability and no evidence for responders in a large double-blind placebo-controlled trial.,"BACKGROUND
Transcranial direct current stimulation (tDCS) has emerged as a non-invasive brain stimulation technique. Most studies show that anodal tDCS increases cortical excitability. However, this effect has been found to be highly variable.
OBJECTIVE
To test the effect of anodal tDCS on cortical excitability and the interaction effect of two participant-specific factors that may explain individual differences in sensitivity to anodal tDCS: the Brain Derived Neurotrophic Factor Val66Met polymorphism (BDNF genotype) and the latency difference between anterior-posterior and lateromedial TMS pulses (APLM latency).
METHODS
In 62 healthy participants, cortical excitability over the left motor cortex was measured before and after anodal tDCS at 2 mA for 20 min in a pre-registered, double-blind, randomized, placebo-controlled trial with repeated measures.
RESULTS
We did not find a main effect of anodal tDCS, nor an interaction effect of the participant-specific predictors. Moreover, further analyses did not provide evidence for the existence of responders and non-responders.
CONCLUSION
This study indicates that anodal tDCS at 2 mA for 20 min may not reliably affect cortical excitability.",2020,"We did not find a main effect of anodal tDCS, nor an interaction effect of the participant-specific predictors.",['62 healthy participants'],"['Transcranial direct current stimulation (tDCS', 'placebo', 'anodal tDCS']","['motor cortical excitability', 'cortical excitability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}]",62.0,0.431948,"We did not find a main effect of anodal tDCS, nor an interaction effect of the participant-specific predictors.","[{'ForeName': 'Zeb D', 'Initials': 'ZD', 'LastName': 'Jonker', 'Affiliation': 'Department of Neuroscience, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Rehabilitation Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Rijndam Rehabilitation Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Gaiser', 'Affiliation': 'Department of Neuroscience, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Joke H M', 'Initials': 'JHM', 'LastName': 'Tulen', 'Affiliation': 'Department of Psychiatry, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Gerard M', 'Initials': 'GM', 'LastName': 'Ribbers', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Rijndam Rehabilitation Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Maarten A', 'Initials': 'MA', 'LastName': 'Frens', 'Affiliation': 'Department of Neuroscience, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Ruud W', 'Initials': 'RW', 'LastName': 'Selles', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Plastic and Reconstructive Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands. Electronic address: r.selles@erasmusmc.nl.'}]",Brain stimulation,['10.1016/j.brs.2020.11.005']
1567,33197657,The effect of selenium and vitamin E supplementation on anti-Mullerian hormone and antral follicle count in infertile women with occult premature ovarian insufficiency: A randomized controlled clinical trial.,"OBJECTIVE
Increased accumulation of reactive oxygen species (ROS) in the process of oogenesis is one of the most well known causes of ovarian insufficiency and decreased ovarian reserve. Selenium and vitamin E as cofactors of glutathione peroxidase plays an important role in the removal of ROS in the ovary. We evaluated the effects of selenium and vitamin E supplementation on anti-Mullerian hormone (AMH) index and antral follicle count (AFC) (primary outcomes) and mean ovarian volume (MOV) and side effects of these supplements (secondary outcome) in infertile women with occult premature ovarian insufficiency (OPOI).
METHODS
70 patients were allocated into the control and treatment groups through block randomization method. 35 women in the treatment group received 200 ng selenium and 400IU vitamin E and 35 women in the control group received placebo for a total of 90 days. AMH index, AFC and mean ovarian volume (MOV) were investigated in both groups after 12 months of study.
RESULT
There was no significant difference between groups before intervention in AMH (Mean difference: -0.08; 95% CI: -0.20 to.08; p=0.33), AFC (-0.71; 95%CI: -1.44 to -0.01; p=0.05) and MOV (-0.55; 95% CI: -0.85 to -0.24; p=0.001). There was a significant increase in AMH (mean difference: 0.59; 95% CI: 0.48 to 0.71; p<0.001), AFC (5.08; 95% CI: 4.36 to 5.08; p<0.001) and MOV (2.17; 95% CI: 1.87 to 2.47; p<0.001) in selenium + vitamin E group compared to placebo group 12 months after intervention. These supplements had no side effects.
CONCLUSION
Supplementation with selenium and vitamin E can increase AMH, AFC and MOV in women with OPOI.",2020,"There was a significant increase in AMH (mean difference: 0.59; 95% CI: 0.48 to 0.71; p<0.001), AFC (5.08; 95% CI: 4.36 to 5.08; p<0.001) and MOV (2.17; 95% CI: 1.87 to 2.47; p<0.001) in selenium + vitamin E group compared to placebo group 12 months after intervention.","['women with OPOI', 'infertile women with occult premature ovarian insufficiency (OPOI', '70 patients', 'infertile women with occult premature ovarian insufficiency', '35 women']","['200\u202fng selenium and 400IU vitamin E', 'selenium and vitamin E supplementation', 'placebo', 'Selenium and vitamin E', 'selenium and vitamin E']","['AMH, AFC and MOV', 'AFC', 'anti-Mullerian hormone and antral follicle count', 'MOV', 'AMH', 'anti-Mullerian hormone (AMH) index and antral follicle count (AFC) (primary outcomes) and mean ovarian volume (MOV) and side effects', 'AMH index, AFC and mean ovarian volume (MOV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028794', 'cui_str': 'Occultism'}, {'cui': 'C0025322', 'cui_str': 'Premature menopause'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0066928', 'cui_str': 'Mullerian regression factor'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",70.0,0.542002,"There was a significant increase in AMH (mean difference: 0.59; 95% CI: 0.48 to 0.71; p<0.001), AFC (5.08; 95% CI: 4.36 to 5.08; p<0.001) and MOV (2.17; 95% CI: 1.87 to 2.47; p<0.001) in selenium + vitamin E group compared to placebo group 12 months after intervention.","[{'ForeName': 'Farhadi Dizaji', 'Initials': 'FD', 'LastName': 'Safiyeh', 'Affiliation': 'Department of midwifery, nursing and midwifery Faculty, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Mirghafourvand', 'Initials': 'M', 'LastName': 'Mojgan', 'Affiliation': 'Social Determinants of Health Research Center, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahabi', 'Initials': 'S', 'LastName': 'Parviz', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Alizadeh', 'Initials': 'MA', 'LastName': 'Sakineh', 'Affiliation': 'Department of midwifery, nursing and midwifery Faculty, Tabriz University of Medical sciences, Tabriz, Iran.'}, {'ForeName': 'Sadeghzadeh Oskouei', 'Initials': 'SO', 'LastName': 'Behnaz', 'Affiliation': 'Department of midwifery, nursing and midwifery Faculty, Tabriz University of Medical sciences, Tabriz, Iran. Electronic address: repbio.sbmu@gmail.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102533']
1568,33226425,Effect of Ezogabine on Cortical and Spinal Motor Neuron Excitability in Amyotrophic Lateral Sclerosis: A Randomized Clinical Trial.,"Importance
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease of the motor nervous system. Clinical studies have demonstrated cortical and spinal motor neuron hyperexcitability using transcranial magnetic stimulation and threshold tracking nerve conduction studies, respectively, although metrics of excitability have not been used as pharmacodynamic biomarkers in multi-site clinical trials.
Objective
To ascertain whether ezogabine decreases cortical and spinal motor neuron excitability in ALS.
Design, Setting, and Participants
This double-blind, placebo-controlled phase 2 randomized clinical trial sought consent from eligible participants from November 3, 2015, to November 9, 2017, and was conducted at 12 US sites within the Northeast ALS Consortium. Participants were randomized in equal numbers to a higher or lower dose of ezogabine or to an identical matched placebo, and they completed in-person visits at screening, baseline, week 6, and week 8 for clinical assessment and neurophysiological measurements.
Interventions
Participants were randomized to receive 600 mg/d or 900 mg/d of ezogabine or a matched placebo for 10 weeks.
Main Outcomes and Measures
The primary outcome was change in short-interval intracortical inhibition (SICI; SICI-1 was used in analysis to reflect stronger inhibition from an increase in amplitude) from pretreatment mean at screening and baseline to the full-dose treatment mean at weeks 6 and 8. The secondary outcomes included levels of cortical motor neuron excitability (including resting motor threshold) measured by transcranial magnetic stimulation and spinal motor neuron excitability (including strength-duration time constant) measured by threshold tracking nerve conduction studies.
Results
A total of 65 participants were randomized to placebo (23), 600 mg/d of ezogabine (23), and 900 mg/d of ezogabine (19 participants); 45 were men (69.2%) and the mean (SD) age was 58.3 (8.8) years. The SICI-1 increased by 53% (mean ratio, 1.53; 95% CI, 1.12-2.09; P = .009) in the 900-mg/d ezogabine group vs placebo group. The SICI-1 did not change in the 600-mg/d ezogabine group vs placebo group (mean ratio, 1.15; 95% CI, 0.87-1.52; P = .31). The resting motor threshold increased in the 600-mg/d ezogabine group vs placebo group (mean ratio, 4.61; 95% CI, 0.21-9.01; P = .04) but not in the 900-mg/d ezogabine group vs placebo group (mean ratio, 1.95; 95% CI, -2.64 to 6.54; P = .40). Ezogabine caused a dose-dependent decrease in excitability by several other metrics, including strength-duration time constant in the 900-mg/d ezogabine group vs placebo group (mean ratio, 0.73; 95% CI, 0.60 to 0.87; P < .001).
Conclusions and Relevance
Ezogabine decreased cortical and spinal motor neuron excitability in participants with ALS, suggesting that such neurophysiological metrics may be used as pharmacodynamic biomarkers in multisite clinical trials.
Trial Registration
ClinicalTrials.gov Identifier: NCT02450552.",2020,"The SICI-1 did not change in the 600-mg/d ezogabine group vs placebo group (mean ratio, 1.15; 95% CI, 0.87-1.52; P = .31).","['Amyotrophic Lateral Sclerosis', 'eligible participants from November 3, 2015, to November 9, 2017, and was conducted at 12 US sites within the Northeast ALS Consortium', 'participants with ALS', '19 participants); 45 were men (69.2%) and the mean (SD) age was 58.3 (8.8) years', '65 participants']","['ezogabine or to an identical matched placebo', 'placebo', 'transcranial magnetic stimulation', 'ezogabine or a matched placebo', 'Ezogabine', 'ezogabine']","['resting motor threshold', 'strength-duration time constant', 'change in short-interval intracortical inhibition (SICI; SICI-1', 'amplitude', 'levels of cortical motor neuron excitability (including resting motor threshold) measured by transcranial magnetic stimulation and spinal motor neuron excitability (including strength-duration time constant', 'SICI-1', 'excitability']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517882', 'cui_str': '8.8'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0530684', 'cui_str': 'ezogabine'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0026609', 'cui_str': 'Motor neuron'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",65.0,0.665985,"The SICI-1 did not change in the 600-mg/d ezogabine group vs placebo group (mean ratio, 1.15; 95% CI, 0.87-1.52; P = .31).","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Wainger', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston MA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Vucic', 'Affiliation': 'Department of Neurology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'McIlduff', 'Affiliation': 'Harvard Medical School, Boston MA.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Maragakis', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bedlack', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': 'Department of Neurology, University of California Irvine, Irvine.'}, {'ForeName': 'Seward B', 'Initials': 'SB', 'LastName': 'Rutkove', 'Affiliation': 'Harvard Medical School, Boston MA.'}, {'ForeName': 'Dale J', 'Initials': 'DJ', 'LastName': 'Lange', 'Affiliation': 'Department of Neurology, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'Department of Neurology, Augusta University Medical Center, Augusta, Georgia.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': 'Department of Neurology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Shafeeq S', 'Initials': 'SS', 'LastName': 'Ladha', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mauricio', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Baloh', 'Affiliation': 'Department of Neurology, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Simmons', 'Affiliation': 'Department of Neurology, Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Sylvia Baedorf', 'Initials': 'SB', 'LastName': 'Kassis', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Thuong', 'Initials': 'T', 'LastName': 'La', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Armineuza', 'Initials': 'A', 'LastName': 'Evora', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Klements', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Aura', 'Initials': 'A', 'LastName': 'Hurtado', 'Affiliation': 'Harvard Medical School, Boston MA.'}, {'ForeName': 'Joao D', 'Initials': 'JD', 'LastName': 'Pereira', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Koh', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Pablo A', 'Initials': 'PA', 'LastName': 'Celnik', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Neurology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Karissa', 'Initials': 'K', 'LastName': 'Gable', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Vern C', 'Initials': 'VC', 'LastName': 'Juel', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Phielipp', 'Affiliation': 'Department of Neurology, University of California Irvine, Irvine.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Marei', 'Affiliation': 'Department of Neurology, Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry, Augusta University Medical Center, Augusta, Georgia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Meehan', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Oskarsson', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Department of Neurology, Cedars Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Divpreet', 'Initials': 'D', 'LastName': 'Kaur', 'Affiliation': 'Department of Neurology, Penn State Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Kiskinis', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Clifford J', 'Initials': 'CJ', 'LastName': 'Woolf', 'Affiliation': 'Harvard Medical School, Boston MA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Eggan', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Weiss', 'Affiliation': 'Department of Neurology, University of Washington, Seattle.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'David', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Davila-Perez', 'Affiliation': 'Harvard Medical School, Boston MA.'}, {'ForeName': 'Joan A', 'Initials': 'JA', 'LastName': 'Camprodon', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pascual-Leone', 'Affiliation': 'Harvard Medical School, Boston MA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Kiernan', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, Arizona.'}, {'ForeName': 'Nazem', 'Initials': 'N', 'LastName': 'Atassi', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': 'The Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Boston.'}]",JAMA neurology,['10.1001/jamaneurol.2020.4300']
1569,33221392,The effect of antecedent exercise on the acute stress response and subsequent food consumption: a preliminary investigation.,"Physical activity has been shown to be protective against many of the deleterious consequences of stress; however, the effects of exercise on stress-induced food consumption are unclear. This study examined the effect of an acute bout of exercise prior to exposure to an acute stressor on subsequent eating behavior, together with the physiological (e.g., heart rate, blood pressure, salivary cortisol) and psychological (e.g., mood, perceived stress) responses to stress. Twenty-three men and women completed four experimental conditions (control, exercise only, stress only, and exercise prior to stress) conducted in a counterbalanced order using a within-subjects repeated measures design. Ad libitum energy intake from a laboratory test meal was assessed at each trial, together with monitoring of physiological and psychological responses. No difference in total energy intake (p = 0.146) or energy intake from 'unhealthy' foods was noted between conditions (p = 0.783), despite lower circulating ghrelin when antecedent exercise was performed compared with stress alone (p < 0.05). Exposure to an acute stressor is not necessarily associated with alterations in subsequent food intake, nor does antecedent exercise prior to stress exposure affect food choices, despite transient alterations in the hunger hormone ghrelin.",2020,"No difference in total energy intake (p = 0.146) or energy intake from 'unhealthy' foods was noted between conditions (p = 0.783), despite lower circulating ghrelin when antecedent exercise was performed compared with stress alone (p < 0.05).",['Twenty-three men and women completed four'],"['experimental conditions (control, exercise only, stress only, and exercise prior to stress', 'antecedent exercise']","[""energy intake from 'unhealthy' foods"", 'total energy intake', 'acute stress response and subsequent food consumption', 'subsequent eating behavior, together with the physiological (e.g., heart rate, blood pressure, salivary cortisol) and psychological (e.g., mood, perceived stress) responses to stress']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",23.0,0.0265626,"No difference in total energy intake (p = 0.146) or energy intake from 'unhealthy' foods was noted between conditions (p = 0.783), despite lower circulating ghrelin when antecedent exercise was performed compared with stress alone (p < 0.05).","[{'ForeName': 'Shina', 'Initials': 'S', 'LastName': 'Leow', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, 35 Stirling Highway, Crawley, Perth, WA 6009, Australia. Electronic address: shina_lee@nysi.org.sg.'}, {'ForeName': 'Natalya J', 'Initials': 'NJ', 'LastName': 'Beer', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, 35 Stirling Highway, Crawley, Perth, WA 6009, Australia.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Dimmock', 'Affiliation': 'Department of Psychology, College of Healthcare Sciences, James Cook University, Townsville, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, 35 Stirling Highway, Crawley, Perth, WA 6009, Australia.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Alderson', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, 35 Stirling Highway, Crawley, Perth, WA 6009, Australia; Minderoo Tech & Policy Lab, University of Western Australia, 35 Stirling Highway, Crawley, Perth, WA 6009, Australia; SPRINZ, Faculty of Health and Environmental Sciences, Auckland University of Technology, Auckland 1142, New Zealand.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Clarke', 'Affiliation': 'Metabolomics Australia, Centre for Microscopy, Characterisation and Analysis, The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Kym J', 'Initials': 'KJ', 'LastName': 'Guelfi', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, 35 Stirling Highway, Crawley, Perth, WA 6009, Australia.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113256']
1570,33221631,A 16-week randomized placebo-controlled trial investigating the effects of omega-3 polyunsaturated fatty acid treatment on white matter microstructure in recent-onset psychosis patients concurrently treated with risperidone.,"We examined the impact of treatment with fish oil (FO), a rich source of omega-3 polyunsaturated fatty acids (n-3 PUFA), on white matter in 37 recent-onset psychosis patients receiving risperidone in a double-blind placebo-controlled randomized clinical trial. Patients were scanned at baseline and randomly assigned to receive 16-weeks of treatment with risperidone + FO or risperidone + placebo. Eighteen patients received follow-up MRIs (FO, n = 10/Placebo, n = 8). Erythrocyte levels of n-3 PUFAs eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA) were obtained at both time points. We employed Free Water Imaging metrics representing the extracellular free water fraction (FW) and fractional anisotropy of the tissue (FA-t). Analyses were conducted using Tract-Based-Spatial-Statistics and nonparametric permutation-based tests with family-wise error correction. There were significant positive correlations of FA-t with DHA and DPA among all patients at baseline. Patients treated with risperidone + placebo demonstrated reductions in FA-t and increases in FW, whereas patients treated with risperidone + FO exhibited no significant changes in FW and FA-t reductions were largely attenuated. The correlations of DPA and DHA with baseline FA-t support the hypothesis that n-3 PUFA intake or biosynthesis are associated with white matter abnormalities in psychosis. Adjuvant FO treatment may partially mitigate against white matter alterations observed in recent-onset psychosis patients following risperidone treatment.",2020,"Patients treated with risperidone + placebo demonstrated reductions in FA-t and increases in FW, whereas patients treated with risperidone + FO exhibited no significant changes in FW and FA-t reductions were largely attenuated.","['37 recent-onset psychosis patients receiving', 'white matter microstructure in recent-onset psychosis patients concurrently treated with']","['placebo', 'risperidone + FO or risperidone + placebo', 'omega-3 polyunsaturated fatty acid treatment', 'risperidone + placebo', 'risperidone + FO', 'fish oil (FO), a rich source of omega-3 polyunsaturated fatty acids (n-3 PUFA', 'risperidone']","['Erythrocyte levels of n-3 PUFAs eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), and docosapentaenoic acid (DPA', 'FW and FA-t reductions', 'FA-t and increases in FW']","[{'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.260786,"Patients treated with risperidone + placebo demonstrated reductions in FA-t and increases in FW, whereas patients treated with risperidone + FO exhibited no significant changes in FW and FA-t reductions were largely attenuated.","[{'ForeName': 'Amanda E', 'Initials': 'AE', 'LastName': 'Lyall', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States. Electronic address: alyall@bwh.harvard.edu.""}, {'ForeName': 'Felix L', 'Initials': 'FL', 'LastName': 'Nägele', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Psychiatry Neuroimaging Branch, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, University of Hamburg, Hamburg, Germany.""}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Pasternak', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Gallego', 'Affiliation': 'Departments of Psychiatry and of Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States; Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Malhotra', 'Affiliation': 'Departments of Psychiatry and of Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States; Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Lipidomics Research Program, University of Cincinnati, United States.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Kubicki', 'Affiliation': ""Psychiatry Neuroimaging Laboratory, Department of Psychiatry, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, United States.""}, {'ForeName': 'Bart D', 'Initials': 'BD', 'LastName': 'Peters', 'Affiliation': 'Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': 'Departments of Psychiatry and of Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States; Feinstein Institutes for Medical Research, Manhasset, NY, United States.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Szeszko', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States; Mental Illness Research, Education and Clinical Center, James J. Peters VA Medical Center, Bronx, NY, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111219']
1571,33221689,"Ten year outcomes for the prospective randomised trial comparing unlinked, modular bicompartmental knee arthroplasty and total knee arthroplasty.","BACKGROUND
A sizeable proportion of knee osteoarthritis is limited to the medial and patellofemoral compartments. Whilst short- and medium-term studies comparing bicompartmental knee arthroplasty (BCA) and total knee arthroplasty (TKA) have shown similar outcome scores, there are no studies comparing long-term outcomes. This study aims to determine which procedure resulted in superior long-term outcome scores.
METHODS
Forty-eight patients with medial and patellofemoral compartment knee osteoarthritis were randomised to receive treatment in two groups: unlinked, modular BCA and TKA. The main outcome measures compared were the range of motion, Knee Society Function Score, Knee Society Knee Score, Oxford Knee Score, Physical Component Score and Mental Component Score of SF-36 pre-operatively and post-operatively up to 10 years. Radiographs of the operated knees were taken pre-operatively, post-operatively and at 10-year follow-up.
RESULTS
Twenty-six underwent BCA and 22 underwent TKA. Overall improvement was seen in both groups compared to pre-operatively, however there were no significant differences detected between the groups at 10 years. The median Hip-Knee-Ankle (HKA) angle was 183.38 (175.17-187.94) in the BCA group and 180.73 (174.96-185.65) in the TKA group. One patient from the BCA group had a peri-prosthetic fracture necessitating revision surgery to a TKA.
CONCLUSIONS
Outcome scores for BCA results were comparable to TKA at long-term follow-up. BCA is an alternative arthroplasty option in selected patients.",2020,"Overall improvement was seen in both groups compared to pre-operatively, however there were no significant differences detected between the groups at 10 years.","['selected patients', 'Forty-eight patients with medial and patellofemoral compartment knee osteoarthritis']","['modular bicompartmental knee arthroplasty and total knee arthroplasty', 'bicompartmental knee arthroplasty (BCA) and total knee arthroplasty (TKA', 'TKA', 'unlinked, modular BCA and TKA', 'BCA']","['range of motion, Knee Society Function Score, Knee Society Knee Score, Oxford Knee Score, Physical Component Score and Mental Component Score of', 'Overall improvement', 'peri-prosthetic fracture necessitating revision surgery', 'median Hip-Knee-Ankle (HKA) angle']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0447798', 'cui_str': 'Compartment of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",48.0,0.0678608,"Overall improvement was seen in both groups compared to pre-operatively, however there were no significant differences detected between the groups at 10 years.","[{'ForeName': 'Jeremy Keng Meng', 'Initials': 'JKM', 'LastName': 'Goh', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road Academia Building Level 4, Singapore 119228, Singapore. Electronic address: jeremy.goh2@mohh.com.sg.'}, {'ForeName': 'Jerry Yongqiang', 'Initials': 'JY', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road Academia Building Level 4, Singapore 119228, Singapore.'}, {'ForeName': 'Nicholas Eng Meng', 'Initials': 'NEM', 'LastName': 'Yeo', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road Academia Building Level 4, Singapore 119228, Singapore.'}, {'ForeName': 'Ming Han Lincoln', 'Initials': 'MHL', 'LastName': 'Liow', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road Academia Building Level 4, Singapore 119228, Singapore.'}, {'ForeName': 'Shi-Lu', 'Initials': 'SL', 'LastName': 'Chia', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road Academia Building Level 4, Singapore 119228, Singapore.'}, {'ForeName': 'Seng Jin', 'Initials': 'SJ', 'LastName': 'Yeo', 'Affiliation': 'Department of Orthopaedic Surgery, Singapore General Hospital, Outram Road Academia Building Level 4, Singapore 119228, Singapore.'}]",The Knee,['10.1016/j.knee.2020.08.013']
1572,33221700,Dietary supplementation with docosahexaenoic acid rich fish oil increases circulating levels of testosterone in overweight and obese men.,"Pre-clinical evidence suggests that omega-3 (n-3) polyunsaturated fatty acids (PUFAs), in particular, docosahexaenoic acid (DHA) have been shown to affect testosterone synthesis in males. This study is a secondary analysis of a randomized controlled trial which determined the effect of a DHA-enriched fish oil supplement on insulin resistance. The aim of the current study was to determine whether testosterone levels change in response to a DHA-enriched fish oil intervention. Overweight and obese men and women without diabetes were recruited to the study. Participants were stratified by sex and randomly allocated to intervention (860 mg DHA + 120 g EPA/day; FO) or an isocaloric control (corn oil; CO) for 12 weeks. A fasted blood sample was collected pre- and post-intervention. Fatty acid composition of erythrocyte membranes was measured using gas chromatography. Total testosterone and metabolic parameters were measured by an accredited commercial pathology laboratory. Sixty-one participants (CO/FO: n = 29/32) were included in the current analysis (male: n = 22, 36.07%). DHA-enriched fish oil supplementation increased total testosterone levels in males after adjusting for baseline levels, age and BMI. There was no treatment effect in females. Changes in testosterone levels in males were positively associated with changes to omega-3 PUFAs EPA and DHA and inversely correlated with omega-6 PUFA, arachidonic acid and dihomo-gamma-linolenic acid content in erythrocyte membranes, and was associated with beneficial changes to fasting insulin and HOMA-IR across the course of the study. DHA-enriched fish oil supplementation increases testosterone levels in overweight and obese men. Further research is warranted to substantiate these findings with a larger sample size and a longer follow-up period.",2020,"Changes in testosterone levels in males were positively associated with changes to omega-3 PUFAs EPA and DHA and inversely correlated with omega-6 PUFA, arachidonic acid and dihomo-gamma-linolenic acid content in erythrocyte membranes, and was associated with beneficial changes to fasting insulin and HOMA-IR across the course of the study.","['Sixty-one participants (CO/FO: n\xa0=\xa029/32) were included in the current analysis (male: n\xa0=\xa022, 36.07', 'males', 'Overweight and obese men and women without diabetes', 'overweight and obese men']","['intervention (860\xa0mg DHA\xa0+\xa0120\xa0g EPA/day; FO) or an isocaloric control (corn oil; CO', 'DHA-enriched fish oil supplement', 'omega-3 (n-3) polyunsaturated fatty acids (PUFAs', 'docosahexaenoic acid rich fish oil', 'DHA-enriched fish oil intervention', 'DHA-enriched fish oil supplementation', 'docosahexaenoic acid (DHA']","['insulin resistance', 'testosterone levels', 'Fatty acid composition of erythrocyte membranes', 'total testosterone levels', 'Total testosterone and metabolic parameters', 'circulating levels of testosterone']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]",61.0,0.296363,"Changes in testosterone levels in males were positively associated with changes to omega-3 PUFAs EPA and DHA and inversely correlated with omega-6 PUFA, arachidonic acid and dihomo-gamma-linolenic acid content in erythrocyte membranes, and was associated with beneficial changes to fasting insulin and HOMA-IR across the course of the study.","[{'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, Newcastle, New South Wales, Australia; Priority Research Centre for Physical Activity and Nutrition, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, Newcastle, New South Wales, Australia; School of Health Sciences, University of Newcastle, New South Wales, Australia.'}, {'ForeName': 'Shamasunder', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'School of Public Health and Medicine, University of Newcastle, Australia; Department of Endocrinology and Diabetes, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'Rohith N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, Newcastle, New South Wales, Australia; Priority Research Centre for Physical Activity and Nutrition, Newcastle, New South Wales, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Manohar L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, Newcastle, New South Wales, Australia; Priority Research Centre for Physical Activity and Nutrition, Newcastle, New South Wales, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand; Corresponding author: 305C Medical Sciences Building, University of Newcastle, Callaghan, NSW - 2308, AUSTRALIA, Tel.: +61 2 4921 5647.. Electronic address: manohar.garg@newcastle.edu.au.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102204']
1573,33222405,Do network centrality measures predict dental outcomes of Indigenous children over time?,"BACKGROUND
Centrality measures identify items that are central to a network, which may inform potential targets for oral interventions.
AIM
We tested whether centrality measures in a cross-sectional network of mothers' baseline factors are able to predict the association with children's dental outcomes at age 5 years.
DESIGN
A network approach was applied to longitudinal data from a randomised controlled trial of dental caries prevention delivered to 448 women pregnant with an Indigenous child in South Australia. Central items were identified at baseline using three centrality measures (strength, betweenness, and closeness). Centrality values of mothers' outcomes were regressed with their predictive values to dental caries experience and dental service utilisation at child age 5 years.
RESULTS
Items of oral health self-efficacy and oral health literacy were central to mothers' baseline network. Strength at baseline explained 51% and 45% of items' predictive values to dental caries experience and dental service utilisation at child age 5 years, respectively. Adjusted and unadjusted values of node strength for the children's oral health network were highly correlated.
CONCLUSION
Strength at baseline successfully identified mothers' items with greater importance to dental caries experience and dental service utilisation at child age 5 years.",2020,Strength at baseline successfully identified mothers' items with greater importance to dental caries experience and dental service utilisation at child age 5 years.,['448 women pregnant with an Indigenous child in South Australia'],[],"['oral health self-efficacy and oral health literacy', 'dental caries experience and dental service utilisation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}]",[],"[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}]",448.0,0.114919,Strength at baseline successfully identified mothers' items with greater importance to dental caries experience and dental service utilisation at child age 5 years.,"[{'ForeName': 'Gustavo Hermes', 'Initials': 'GH', 'LastName': 'Soares', 'Affiliation': 'University of São Paulo Dental School, Butantã, Brazil.'}, {'ForeName': 'Pedro Henrique Ribeiro', 'Initials': 'PHR', 'LastName': 'Santiago', 'Affiliation': 'Australian Research Centre for Population Oral Health, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Maria Gabriela Haye', 'Initials': 'MGH', 'LastName': 'Biazevic', 'Affiliation': 'University of São Paulo Dental School, Butantã, Brazil.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Michel-Crosato', 'Affiliation': 'University of São Paulo Dental School, Butantã, Brazil.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jamieson', 'Affiliation': 'Australian Research Centre for Population Oral Health, The University of Adelaide, Adelaide, SA, Australia.'}]",International journal of paediatric dentistry,['10.1111/ipd.12749']
1574,33222767,"Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND
There is an unmet need to develop therapeutic interventions directed at the neurodegeneration that underlies progression in multiple sclerosis. High-dose, pharmaceutical-grade biotin (MD1003) might enhance neuronal and oligodendrocyte energetics, resulting in improved cell function, repair, or survival. The MS-SPI randomised, double-blind, placebo-controlled study found that MD1003 improved disability outcomes over 12 months in patients with progressive multiple sclerosis. The SPI2 study was designed to assess the safety and efficacy of MD1003 in progressive forms of multiple sclerosis in a larger, more representative patient cohort.
METHODS
SPI2 was a randomised, double-blind, parallel-group, placebo-controlled trial done at 90 academic and community multiple sclerosis clinics across 13 countries. Patients were aged 18-65 years, had a diagnosis of primary or secondary progressive multiple sclerosis fulfilling the revised International Panel criteria and Lublin criteria, a Kurtzke pyramidal functional subscore of at least 2 (defined as minimal disability), an expanded disability status scale (EDSS) score of 3·5-6·5, a timed 25-foot walk (TW25) of less than 40 s, evidence of clinical disability progression, and no relapses in the 2 years before enrolment. Concomitant disease-modifying therapies were allowed. Patients were randomly assigned (1:1) by an independent statistician using an interactive web response system, with stratification by study site and disease history, to receive MD1003 (oral biotin 100 mg three times daily) or placebo. Participants, investigators, and assessors were masked to treatment assignment. The primary endpoint was a composite of the proportion of participants with confirmed improvement in EDSS or TW25 at month 12, confirmed at month 15, versus baseline. The primary endpoint was assessed in the intention-to-treat analysis set, after all participants completed the month 15 visit. Safety analyses included all participants who received at least one dose of MD1003. This trial is registered with ClinicalTrials.gov (NCT02936037) and the EudraCT database (2016-000700-29).
FINDINGS
From Feb 22, 2017, to June 8, 2018, 642 participants were randomly assigned MD1003 (n=326) or placebo (n=316). The double-blind, placebo-controlled phase of the study ended when the primary endpoint for the last-entered participant was assessed on Nov 15, 2019. The mean time in the placebo-controlled phase was 20·1 months (SD 5·3; range 15-27). For the primary outcome, 39 (12%) of 326 patients in the MD1003 group compared with 29 (9%) of 316 in the placebo group improved at month 12, with confirmation at month 15 (odds ratio 1·35 [95% CI 0·81-2·26]). Treatment-emergent adverse events occurred in 277 (84%) of 331 participants in the MD1003 group and in 264 (85%) of 311 in the placebo group. 87 (26%) of 331 participants in the MD1003 group and 82 (26%) of 311 participants in the placebo group had at least one serious treatment-emergent adverse event. One (<1%) person died in the MD1003 group and there were no deaths in the placebo group. Despite use of mitigation strategies, MD1003 led to inaccurate laboratory results for tests using biotinylated antibodies.
INTERPRETATION
This study showed that MD1003 did not significantly improve disability or walking speed in patients with progressive multiple sclerosis and thus, in addition to the potential of MD1003 for deleterious health consequences from interference of laboratory tests, MD1003 cannot be recommended for treatment of progressive multiple sclerosis.
FUNDING
MedDay Pharmaceuticals.",2020,"This study showed that MD1003 did not significantly improve disability or walking speed in patients with progressive multiple sclerosis and thus, in addition to the potential of MD1003 for deleterious health consequences from interference of laboratory tests, MD1003 cannot be recommended for treatment of progressive multiple sclerosis.
","['patients with progressive multiple sclerosis (SPI2', '90 academic and community multiple sclerosis clinics across 13 countries', 'participants who received at least one dose of MD1003', '2016-000700-29).\nFINDINGS\n\n\nFrom Feb 22, 2017, to June 8, 2018, 642 participants were randomly assigned MD1003 (n=326) or', 'Patients were aged 18-65 years, had a diagnosis of primary or secondary progressive multiple sclerosis fulfilling the revised International Panel criteria and Lublin criteria, a Kurtzke pyramidal functional subscore of at least 2 (defined as minimal disability), an expanded disability status scale (EDSS) score of 3·5-6·5, a timed 25-foot walk (TW25) of less than 40 s, evidence of clinical disability progression, and no relapses in the 2 years before enrolment', 'patients with progressive multiple sclerosis', '87 (26%) of 331 participants in the MD1003 group and']","['placebo', 'MD1003', 'MD1003 (high-dose biotin', 'MD1003 (oral biotin 100 mg three times daily) or placebo', 'EudraCT database']","['disability or walking speed', 'intention-to-treat analysis set', 'serious treatment-emergent adverse event', 'Treatment-emergent adverse events', 'safety and efficacy', 'composite of the proportion of participants with confirmed improvement in EDSS or TW25', 'cell function, repair, or survival', 'mean time', 'Safety and efficacy', 'disability outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839267', 'cui_str': 'Multiple sclerosis clinic'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751965', 'cui_str': 'Secondary progressive multiple sclerosis'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0005575', 'cui_str': 'Biotin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",642.0,0.697256,"This study showed that MD1003 did not significantly improve disability or walking speed in patients with progressive multiple sclerosis and thus, in addition to the potential of MD1003 for deleterious health consequences from interference of laboratory tests, MD1003 cannot be recommended for treatment of progressive multiple sclerosis.
","[{'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA. Electronic address: bruce.cree@ucsf.edu.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'University of Alabama, School of Public Health, Birmingham, AL, USA.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'The University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Institute of Experimental Neurology, IRCCS San Raffaele Hospital, Milan, Italy.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, London, UK.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'Department of Neurology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Arnold', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kuhle', 'Affiliation': 'Neurologic Clinic and Policlinic, Departments of Medicine, Biomedicine, and Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Block', 'Affiliation': 'Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Frederick E', 'Initials': 'FE', 'LastName': 'Munschauer', 'Affiliation': 'MedDay Pharmaceuticals, Boston, MA, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Sedel', 'Affiliation': 'MedDay Pharmaceuticals, Paris, France.'}, {'ForeName': 'Fred D', 'Initials': 'FD', 'LastName': 'Lublin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30347-1']
1575,33196410,An intervention to improve the quality of life in children of parents with serious mental illness: the Young SMILES feasibility RCT.,"BACKGROUND
Quality of life for children and adolescents living with serious parental mental illness can be impaired, but evidence-based interventions to improve it are scarce.
OBJECTIVE
Co-production of a child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES)] to improve the health-related quality of life of children and adolescents living with serious parental mental illness, and evaluating its acceptability and feasibility for delivery in NHS and community settings.
DESIGN
Qualitative and co-production methods informed the development of the intervention (Phase I). A feasibility randomised controlled trial was designed to compare Young SMILES with treatment as usual (Phase II). Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents. A mixture of semistructured qualitative interviews and focus group research was used to examine feasibility among Young SMILES facilitators and referrers/non-referrers.
SETTING
Randomisation was conducted after baseline measures were collected by the study co-ordinator, ensuring that the blinding of the statistician and research team was maintained to reduce detection bias.
PARTICIPANTS
Phase I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors. Phase II: 40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators.
INTERVENTION
Young SMILES was delivered at two sites: (1) Warrington, supported by the National Society for the Prevention of Cruelty to Children (NSPCC), and (2) Newcastle, supported by the NHS and Barnardo's. An eight-session weekly group programme was delivered, with four to six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years). At week 4, a five-session parallel weekly programme was offered to the parents/carers. Sessions lasted 2 hours each and focused on improving mental health literacy, child-parent communication and children's problem-solving skills.
MAIN OUTCOME MEASURES
Phase ll children and parents completed questionnaires at randomisation and then again at 4 and 6 months post randomisation. Quality of life was self-reported by children and proxy-reported by parents using the Paediatric Quality of Life questionnaire and KIDSCREEN. Semistructured interviews with parents ( n = 14) and children ( n = 17) who participated in the Young SMILES groups gathered information about their motivation to sign up to the study, their experiences of participating in the group sessions, and their perceived changes in themselves and their family members following intervention. Further interviews with individual referrers ( n = 5) gathered information about challenges to recruitment and randomisation. Two focus groups ( n = 16) with practitioners who facilitated the intervention explored their views of the format and content of the Young SMILES manual and their suggestions for changes.
RESULTS
A total of 35 families were recruited: 20 were randomly allocated to Young SMILES group and 15 to treatment as usual. Of those, 28 families [15/20 (75%) in the intervention group and 13/15 (87%) in the control group] gave follow-up data at the primary end point (4 months post baseline). Participating children had high adherence to the intervention and high completion rates of the questionnaires. Children and adolescents living with their parents, who had serious mental illness, and their parents were mainly very positive and enthusiastic about Young SMILES, both of whom invoked the benefits of peer support and insight into parental difficulties. Although facilitators regarded Young SMILES as a meaningful and distinctive intervention having great potential, referrers identified several barriers to referring families to the study. One harm was reported by a parent, which was dealt with by the research team and the NSPCC in accordance with the standard operating procedures.
LIMITATIONS
The findings from our feasibility study are not sufficient to recommend a fully powered trial of Young SMILES in the near future. Although it was feasible to randomise children and adolescents living with serious parental mental illness of different ages to standardised, time-limited groups in both NHS and non-NHS settings, an intervention like Young SMILES is unlikely to address underlying core components of the vulnerability that children and adolescents living with serious parental mental illness express as a population over time.
CONCLUSIONS
Young SMILES was widely valued as unique in filling a recognised gap in need. Outcome measures in future studies of interventions for children and adolescents living with serious parental mental illness are more likely to capture change in individual risk factors for reduced quality of life by considering their unmet need, rather than on an aggregate construct of health-related quality of life overall, which may not reflect these young people's needs.
FUTURE WORK
A public health approach to intervention might be best. Most children and adolescents living with serious parental mental illness remain well most of the time, so, although their absolute risks are low across outcomes (and most will remain resilient most of the time), consistent population estimates find their relative risk to be high compared with unexposed children. A public health approach to intervention needs to be both tailored to the particular needs of children and adolescents living with serious parental mental illness and agile to these needs so that it can respond to fluctuations over time.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN36865046.
FUNDING
This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 59. See the NIHR Journals Library website for further project information.",2020,"Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents.","['Children and adolescents living with their parents, who had serious mental illness', 'six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years', 'children and adolescents living with their parents, who had serious mental illness, and their parents', 'children and adolescents living with serious parental mental illness', 'children of parents with serious mental illness', 'A total of 35 families were recruited: 20', 'I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors', '40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators', 'Semistructured interviews with parents ( n \u2009=\u200914) and children ( n \u2009=\u200917) who participated']",['child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES'],"['quality of life', 'Quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557133', 'cui_str': 'Lives with parents'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",35.0,0.0615208,"Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents.","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Abel', 'Affiliation': ""Centre for Women's Mental Health, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Bee', 'Affiliation': 'Division of Nursing, School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Gega', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gellatly', 'Affiliation': ""Centre for Women's Mental Health, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Adekeye', 'Initials': 'A', 'LastName': 'Kolade', 'Affiliation': ""Centre for Women's Mental Health, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hunter', 'Affiliation': 'National Society for the Prevention of Cruelty to Children, London, UK.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Callender', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lesley-Anne', 'Initials': 'LA', 'LastName': 'Carter', 'Affiliation': 'Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Meacock', 'Affiliation': 'Manchester Centre for Health Economics, University of Manchester, Manchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bower', 'Affiliation': 'National Primary Care Research and Development Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Stanley', 'Affiliation': 'School of Social Work, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Calam', 'Affiliation': 'Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Wolpert', 'Affiliation': 'Evidence Based Practice Unit, University College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stewart', 'Affiliation': 'National Society for the Prevention of Cruelty to Children, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department for Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'Department of Social Work, Education and Community Wellbeing, University of Northumbria, Newcastle upon Tyne, UK.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Linklater', 'Affiliation': 'Department of Education and Inclusive Pedagogy, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Douglas', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Stokes-Crossley', 'Affiliation': 'Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24590']
1576,33196931,Wielding a gun increases judgments of others as holding guns: a randomized controlled trial.,"The gun embodiment effect is the consequence caused by wielding a gun on judgments of whether others are also holding a gun. This effect could be responsible for real-world instances when police officers shoot an unarmed person because of the misperception that the person had a gun. The gun embodiment effect is an instance of embodied cognition for which a person's tool-augmented body affects their judgments. The replication crisis in psychology has raised concern about embodied cognition effects in particular, and the issue of low statistical power applies to the original research on the gun embodiment effect. Thus, the first step was to conduct a high-powered replication. We found a significant gun embodiment effect in participants' reaction times and in their proportion of correct responses, but not in signal detection measures of bias, as had been originally reported. To help prevent the gun embodiment effect from leading to fatal encounters, it would be useful to know whether individuals with certain traits are less prone to the effect and whether certain kinds of experiences help alleviate the effect. With the new and reliable measure of the gun embodiment effect, we tested for moderation by individual differences related to prior gun experience, attitudes, personality, and factors related to emotion regulation and impulsivity. Despite the variety of these measures, there was little evidence for moderation. The results were more consistent with the idea of the gun embodiment effect being a universal, fixed effect, than being a flexible, malleable effect.",2020,"We found a significant gun embodiment effect in participants' reaction times and in their proportion of correct responses, but not in signal detection measures of bias, as had been originally reported.",[],[],[],[],[],[],,0.0260932,"We found a significant gun embodiment effect in participants' reaction times and in their proportion of correct responses, but not in signal detection measures of bias, as had been originally reported.","[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Witt', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, 80523, USA. Jessica.Witt@colostate.edu.'}, {'ForeName': 'Jamie E', 'Initials': 'JE', 'LastName': 'Parnes', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, 80523, USA.'}, {'ForeName': 'Nathan L', 'Initials': 'NL', 'LastName': 'Tenhundfeld', 'Affiliation': 'University of Alabama in Huntsville, Huntsville, AL, USA.'}]",Cognitive research: principles and implications,['10.1186/s41235-020-00260-3']
1577,33197681,Effects of situational simulation and online first-aid training programs for nurses in general medical wards: A prospective study.,"BACKGROUND
To maintain patient safety, effective first-aid skills are necessary during emergencies. It is important to develop in-service education programs to equip clinical nurses with first-aid skills.
OBJECTIVES
This study explored the effects of first-aid skills and knowledge between situational simulation training and online teaching. It also examined the different effects of two training programs associated with nurses' baseline first-aid ability.
DESIGN
This was a randomized, single-blind controlled study.
SETTING
The study was conducted from December 15, 2016 to May 28, 2018, in the nursing department of a medical center in Taiwan.
PARTICIPANTS
Participants were 92 general ward nurses.
METHODS
Participants were randomly assigned to either a situational simulation training or an online teaching group. We used a first-aid knowledge test (FAKT) and a first-aid skills test (FAST) to measure the participants' learning outcomes after intervention and we did cost comparisons between groups.
RESULTS
There were no significant differences in the changes in FAKT and FAST scores after intervention between situational simulation training and online teaching groups (p = 0.76, p = 0.45). All the participants in both training programs showed improvements via increased scores on FAST (M ± SD = 35.27 ± 12.08 for online teaching, M ± SD = 36.08 ± 10.78 for situational simulation training) and FAKT (M ± SD = 21.09 ± 18.59 for online teaching, M ± SD = 23.39 ± 15.36 for situational simulation training). However, for the subgroup of participants who scored <75% on the FAST pretest, better improvements only occurred in the situational simulation training, but the situational simulation training program had higher costs than the online teaching program.
CONCLUSIONS
The improvement was greater in the situational simulation training group among nurses who could not exceed scores of 75% for first-aid skills. First-aid skill scores below 75% are likely a sign of nurses who need more assistance, discussion, and debriefing from situational simulation training.",2020,"There were no significant differences in the changes in FAKT and FAST scores after intervention between situational simulation training and online teaching groups (p = 0.76, p = 0.45).","['December 15, 2016 to May 28, 2018, in the nursing department of a medical center in Taiwan', 'Participants were 92 general ward nurses', 'Participants', 'nurses in general medical wards']","['situational simulation training or an online teaching group', 'situational simulation training', 'situational simulation and online first-aid training programs', 'situational simulation training and online teaching']",['changes in FAKT and FAST scores'],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0043030', 'cui_str': 'Wards, General'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1276379', 'cui_str': 'First aid education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",92.0,0.0213921,"There were no significant differences in the changes in FAKT and FAST scores after intervention between situational simulation training and online teaching groups (p = 0.76, p = 0.45).","[{'ForeName': 'Pei-Yin', 'Initials': 'PY', 'LastName': 'Hsieh', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Hsin-Yi', 'Initials': 'HY', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Chin-Hao', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Research, National Taiwan University Hospital and National Taiwan University College of Medicine, Taiwan.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Hui-Ping', 'Initials': 'HP', 'LastName': 'Cheng', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Chun-Yeuh', 'Initials': 'CY', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Min-Ling', 'Initials': 'ML', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Huey-Jiuan', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Hui-Ting', 'Initials': 'HT', 'LastName': 'Liu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan.'}, {'ForeName': 'Jin-Shing', 'Initials': 'JS', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, National Taiwan University Hospital and National Taiwan University College of Medicine, Taiwan.'}, {'ForeName': 'Fei-Hsiu', 'Initials': 'FH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital and School of Nursing, College of Medicine, National Taiwan University, Taiwan. Electronic address: hsiaofei@ntu.edu.tw.'}]",Nurse education today,['10.1016/j.nedt.2020.104621']
1578,33197808,A randomized controlled trial comparing the efficacies of ketorolac and parecoxib for early pain management after total knee arthroplasty.,"BACKGROUND
Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used to reduce pain after orthopedic surgery. Currently, selective COX-2 inhibitors can provide effective pain reduction with less platelet inhibition compared with conventional NSAIDs. We aimed to compare the analgesic effect and perioperative blood loss (PBL) after total knee arthroplasty (TKA) between ketorolac and parecoxib administration.
METHODS
We conducted a prospective randomized controlled study of 100 unilateral TKAs. The ketorolac group of 50 patients received an intraoperative periarticular injection (PAI) with 100 mg of bupivacaine and 30 mg of ketorolac. Afterwards, 30 mg of ketorolac was intravenously injected every 12 h until 48 h. In the parecoxib group of 50 patients, 20 mg of parecoxib was added to PAI, and the first intravenous dose was 20 mg followed by 40 mg every 12 h. The primary outcomes were visual analog scales (VASs) of postoperative pain, amount of morphine consumption, PBL, and blood transfusion rate.
RESULTS
The ketorolac group had a significantly lower VAS pain score than the parecoxib group at 6 h after TKA (2.38 ± 2.52 vs. 4.12 ± 2.86, P < 0.01). Thereafter, the VAS of both groups and total morphine consumption at 24 and 48 h were comparable. The PBLs of the ketorolac and parecoxib groups were 529.72 ± 263.02 and 402.40 ± 191.47 ml, respectively (P = 0.01). However, the blood transfusion rates between groups were not different.
CONCLUSION
Parecoxib provides comparable analgesic effects to ketorolac. Additionally, perioperative use of parecoxib is safe and is associated with significantly less blood loss after TKA.",2020,The ketorolac group had a significantly lower VAS pain score than the parecoxib group at 6 h after TKA (2.38 ± ,"['early pain management after total knee arthroplasty', 'total knee arthroplasty (TKA', '100 unilateral TKAs']","['ketorolac', 'Parecoxib', 'ketorolac and parecoxib', 'parecoxib', 'intraoperative periarticular injection (PAI) with 100\xa0mg of bupivacaine and 30\xa0mg of ketorolac']","['total morphine consumption', 'visual analog scales (VASs) of postoperative pain, amount of morphine consumption, PBL, and blood transfusion rate', 'blood transfusion rates', 'VAS pain score', 'analgesic effects', 'analgesic effect and perioperative blood loss (PBL', 'blood loss']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",100.0,0.140792,The ketorolac group had a significantly lower VAS pain score than the parecoxib group at 6 h after TKA (2.38 ± ,"[{'ForeName': 'Artit', 'Initials': 'A', 'LastName': 'Laoruengthana', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Piti', 'Initials': 'P', 'LastName': 'Rattanaprichavej', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand. Electronic address: pitir@nu.ac.th.'}, {'ForeName': 'Kongpob', 'Initials': 'K', 'LastName': 'Reosanguanwong', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Bhuwad', 'Initials': 'B', 'LastName': 'Chinwatanawongwan', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Pariphat', 'Initials': 'P', 'LastName': 'Chompoonutprapa', 'Affiliation': 'Department of Orthopaedics, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Krit', 'Initials': 'K', 'LastName': 'Pongpirul', 'Affiliation': 'Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The Knee,['10.1016/j.knee.2020.10.005']
1579,33198147,Brief Relaxation Practice Induces Significantly More Prefrontal Cortex Activation during Arithmetic Tasks Comparing to Viewing Greenery Images as Revealed by Functional Near-Infrared Spectroscopy (fNIRS).,"BACKGROUND
There is little understanding on how brief relaxation practice and viewing greenery images would affect brain responses during cognitive tasks. In the present study, we examined the variation in brain activation of the prefrontal cortex during arithmetic tasks before and after viewing greenery images, brief relaxation practice, and control task using functional near-infrared spectroscopy (fNIRS).
METHOD
This randomized controlled study examined the activation patterns of the prefrontal cortex (PFC) in three groups of research participants who were exposed to viewing greenery images ( n = 10), brief relaxation practice ( n = 10), and control task ( n = 11). The activation pattern of the PFC was measured pre- and post-intervention using a portable fNIRS device and reported as mean total oxygenated hemoglobin (HbO μm). Primary outcome of the study is the difference in HbO μm between post- and pre-intervention readings during a cognitive task that required the research participants to perform arithmetic calculation.
RESULTS
In terms of intervention-related differences, there was significant difference in average HbO μm when performing arithmetic tasks before and after brief relaxation practice ( p < 0.05). There were significant increases in average HbO μm in the right frontopolar cortex ( p = 0.029), the left frontopolar cortex ( p = 0.01), and the left orbitofrontal cortex ( p = 0.033) during arithmetic tasks after brief relaxation practice. In contrast, there were no significant differences in average HbO μm when performing arithmetic tasks before and after viewing greenery images ( p > 0.05) and the control task ( p > 0.05).
CONCLUSION
Our preliminary findings show that brief relaxation practice but not viewing greenery images led to significant frontal lobe activation during arithmetic tasks. The present study demonstrated, for the first time, that there was an increase in activation in neuroanatomical areas including the combined effort of allocation of attentional resources, exploration, and memory performance after the brief relaxation practice. Our findings suggest the possibility that the right frontopolar cortex, the left frontopolar cortex, and the left orbitofrontal cortex may be specifically associated with the benefits of brief relaxation on the brain.",2020,"There were significant increases in average HbO μm in the right frontopolar cortex ( p = 0.029), the left frontopolar cortex ( p = 0.01), and the left orbitofrontal cortex ( p = 0.033) during arithmetic tasks after brief relaxation practice.","['three groups of research participants who were exposed to viewing greenery images ( n = 10), brief relaxation practice ( n = 10), and control task ( n = 11']",['prefrontal cortex (PFC'],"['left frontopolar cortex', 'left orbitofrontal cortex', 'Prefrontal Cortex Activation during Arithmetic Tasks', 'mean total oxygenated hemoglobin (HbO μm', 'HbO μm between post- and pre-intervention readings during a cognitive task that required the research participants to perform arithmetic calculation', 'frontal lobe activation', 'average HbO μm']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}]",,0.0150558,"There were significant increases in average HbO μm in the right frontopolar cortex ( p = 0.029), the left frontopolar cortex ( p = 0.01), and the left orbitofrontal cortex ( p = 0.033) during arithmetic tasks after brief relaxation practice.","[{'ForeName': 'Zhisong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Olszewska-Guizzo', 'Affiliation': 'Institute for Health Innovation and Technology (iHealthtech), National University of Singapore, Singapore 117599, Singapore.'}, {'ForeName': 'Syeda Fabeha', 'Initials': 'SF', 'LastName': 'Husain', 'Affiliation': 'Institute for Health Innovation and Technology (iHealthtech), National University of Singapore, Singapore 117599, Singapore.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bose', 'Affiliation': 'Department of Psychological Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore 119228, Singapore.'}, {'ForeName': 'Jongkwan', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'OBELAB, Inc., Seoul 06212, Korea.'}, {'ForeName': 'Wanqiu', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National University of Singapore (Chongqing) Research Institute, Chongqing 401123, China.'}, {'ForeName': 'Jiayun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Bach', 'Initials': 'B', 'LastName': 'Xuan Tran', 'Affiliation': 'Institute for Preventive Medicine and Public Health, Hanoi Medical University, Hanoi 100000, Vietnam.'}, {'ForeName': 'Bokun', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Science and Technology Promotion Bureau, Chongqing Liangjiang New Area Administration Committee, Chongqing 201205, China.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xuan', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Pinjia', 'Initials': 'P', 'LastName': 'Yan', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Maomao', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}, {'ForeName': 'Cyrus S H', 'Initials': 'CSH', 'LastName': 'Ho', 'Affiliation': 'Department of Psychological Medicine, National University Hospital, Singapore 119074, Singapore.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ho', 'Affiliation': 'Faculty of Education, Huaibei Normal University, Huaibei 117599, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17228366']
1580,33198148,Prospective Trial of CPAP in Community-Dwelling Adults with Down Syndrome and Obstructive Sleep Apnea Syndrome.,"Adults with Down syndrome (DS) are predisposed to obstructive sleep apnoea (OSA), but the effectiveness and acceptability of continuous positive airway pressure treatment (CPAP) in this group has rarely been formally assessed. This study was designed as a pilot randomised, parallel controlled trial for one month, continuing as an uncontrolled cohort study whereby the control group also received the intervention. Symptomatic, community-dwelling DS individuals exhibiting ≥10 apnoeas/hypopneas per hour in bed on a Type 3 home sleep study were invited to participate in this study, with follow-up at 1, 3, 6, and 12 months from baseline. Measurements of sleepiness, behaviour, cognitive function and general health were undertaken; the primary outcome was a change in the pictorial Epworth Sleepiness Scale (pESS) score. Twenty-eight participants (19 male) were enrolled: age 28 ± 9 year; body mass index 31.5 ± 7.9 kg/m 2 ; 39.6 ± 32.2 apnoeas/hypopneas per hour in bed; pESS 11 ± 6/24. The pilot randomised controlled trial at one month demonstrated no change between the groups. At 12 months, participant ( p = 0.001) pESS and Disruptive ( p < 0.0001), Anxiety/Antisocial ( p = 0.024), and Depressive ( p = 0.008) behaviour scores were reduced compared to baseline. Improvement was noted in verbal ( p = 0.001) and nonverbal intelligence scores ( p = 0.011). General health scores also improved ( p = 0.02). At the end of the trial, 19 participants continued on treatment. Use of CPAP in adults with DS and OSA led to a number of significant, sustained improvements in sleepiness and behavioural/emotional outcomes at 12 months.",2020,Improvement was noted in verbal ( p = 0.001) and nonverbal intelligence scores ( p = 0.011).,"['adults with DS and OSA', 'Community-Dwelling Adults with Down Syndrome and Obstructive Sleep Apnea Syndrome', 'Adults with Down syndrome (DS', 'Twenty-eight participants (19 male) were enrolled: age 28 ± 9 year; body mass index 31.5 ± 7.9 kg/m 2 ; 39.6 ± 32.2 apnoeas/hypopneas per hour in bed; pESS 11 ± 6/24', 'Symptomatic, community-dwelling DS individuals exhibiting ≥10 apnoeas/hypopneas per hour in bed on a Type 3 home sleep study']","['CPAP', 'continuous positive airway pressure treatment (CPAP']","['Measurements of sleepiness, behaviour, cognitive function and general health', 'pictorial Epworth Sleepiness Scale (pESS) score', 'General health scores', 'Anxiety/Antisocial', 'verbal', 'nonverbal intelligence scores', 'behaviour scores', 'sleepiness and behavioural/emotional outcomes', 'Depressive']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0442754', 'cui_str': 'Distance vision 6/24'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",19.0,0.111053,Improvement was noted in verbal ( p = 0.001) and nonverbal intelligence scores ( p = 0.011).,"[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hill', 'Affiliation': 'Sleep Research Unit, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Fairley', 'Affiliation': 'Sleep Research Unit, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Williams', 'Affiliation': 'Centre for Population Health Sciences, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}, {'ForeName': 'Goffredina', 'Initials': 'G', 'LastName': 'Spanò', 'Affiliation': 'Down Syndrome Research Group, Department of Psychology, University of Arizona, Tucson, AZ 85721, USA.'}, {'ForeName': 'Sally-Ann', 'Initials': 'SA', 'LastName': 'Cooper', 'Affiliation': 'Mental Health and Wellbeing Research Group, Institute of Health and Wellbeing, University of Glasgow, Glasgow G12 0XH, UK.'}, {'ForeName': 'Renata L', 'Initials': 'RL', 'LastName': 'Riha', 'Affiliation': 'Sleep Research Unit, Usher Institute, Old Medical School, University of Edinburgh, Teviot Place, Edinburgh EH8 9AG, UK.'}]",Brain sciences,['10.3390/brainsci10110844']
1581,33202219,"Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial.","BACKGROUND
Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.
METHODS
The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.
FINDINGS
Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).
INTERPRETATION
Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.
FUNDING
ACTION Study Group and AstraZeneca.",2020,"INTERPRETATION
Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days.","['1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group', 'stable coronary patients undergoing high-risk elective PCI', 'Eligible patients', '49 hospitals in France and Czech Republic', 'Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic', 'Between Jan 9, 2017, and May 28, 2020', '15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group', 'elective percutaneous coronary intervention (ALPHEUS']","['clopidogrel', 'Ticagrelor versus clopidogrel', 'ticagrelor']","['rate of minor bleeding', 'minor bleeding events', 'periprocedural myocardial necrosis', 'major bleeding', 'periprocedural ischaemic complications', 'composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",1910.0,0.14731,"INTERPRETATION
Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days.","[{'ForeName': 'Johanne', 'Initials': 'J', 'LastName': 'Silvain', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Beygui', 'Affiliation': 'ACTION Study Group, Département de Cardiologie, CHU de Caen, Caen, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Rangé', 'Affiliation': 'Département de Cardiologie, CH de Chartres, Chartres, France.'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Motovska', 'Affiliation': 'Third Faculty of Medicine, Charles University and Cardiocentre Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Jean-Guillaume', 'Initials': 'JG', 'LastName': 'Dillinger', 'Affiliation': 'Université de Paris, Department of Cardiology, Lariboisière Hospital, Assistance Publique-Hôpitaux de Paris, INSERM U942, Paris, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'ACTION Study Group, Département de Cardiologie, CH de Bastia, Bastia, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Hôpital Privé Dijon Bourgogne-Cardiologie Interventionelle GCIDB VALMY, Dijon, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Lhermusier', 'Affiliation': 'Département de Cardiologie, CHU de Toulouse, Toulouse, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Pouillot', 'Affiliation': 'Département de Cardiologie, Clinique Sainte Clotilde, La Réunion, France.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Larrieu-Ardilouze', 'Affiliation': 'Service de Cardiologie, CHU de Poitiers, Poitiers, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Boccara', 'Affiliation': ""AP-HP, Hôpitaux de l'Est Parisien, Hôpital Saint-Antoine, Department of Cardiology, Sorbonne Université-INSERM UMR S_938, Centre de Recherche Saint-Antoine, Paris, France.""}, {'ForeName': 'Jean-Noël', 'Initials': 'JN', 'LastName': 'Labeque', 'Affiliation': 'GCS de Cardiologie de la Côte Basque, CH Bayonne, Bayonne, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'El Kasty', 'Affiliation': ""Département de Cardiologie, Grand Hôpital de l'Est Francilien site Marne-La-Vallée, Marne-la-Vallée, France.""}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Laredo', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Raphaëlle', 'Initials': 'R', 'LastName': 'Dumaine', 'Affiliation': 'Les Grands Prés Cardiac Rehabilitation Centre, Villeneuve St Denis, France.'}, {'ForeName': 'Grégory', 'Initials': 'G', 'LastName': 'Ducrocq', 'Affiliation': 'Université de Paris, Hôpital Bichat, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Collet', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Blanchart', 'Affiliation': 'ACTION Study Group, Département de Cardiologie, CHU de Caen, Caen, France.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kala', 'Affiliation': 'University Hospital Brno, Medical Faculty of Masaryk University Brno, Brno, Czech Republic.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'ACTION Study Group, Unité de Recherche Clinique, Hôpital Fernand Widal (AP-HP), Paris, France; Statistique, Analyse et Modélisation Multidisciplinaire EA 4543, Université Paris 1 Panthéon Sorbonne, Paris, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)32236-4']
1582,33202263,"Attention bias modification in depression: A randomized trial using a novel, reward-based, eye-tracking approach.","BACKGROUND AND OBJECTIVES
Biased attention to negative information is a mechanism for risk and relapse in depression. Attentional bias modification (ABM) paradigms manipulate attention away from negative information to reduce this bias. ABM results have been mixed due to inconsistent methodologies and stimuli design. This randomized controlled trial used a novel approach to modifying attentional bias.
METHODS
An eye tracker manipulated stimuli in response to participants' fixations to preferentially reward attention to positive stimuli by obscuring or enhancing image quality of negative and positive stimuli, respectively. Participants with major depressive disorder completed three 35-min sessions of active (n = 20) or sham (n = 20) ABM training. Attentional bias, memory for emotional words, and mood were assessed pre- and post-training.
RESULTS
Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2 = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2 = 0.096). Active training participants remembered more happy than sad words in an emotional word learning task, indicating a distal transfer of training to emotional memory (p = .036, η p 2 = 0.11). Training did not significantly affect mood in the one-week trial.
LIMITATIONS
Future studies should build on this proof-of-principle study with larger sample sizes and more intensive treatment to explore which mechanisms of training may lead to improvements in mood.
CONCLUSIONS
Attention biases in depression are modifiable through reward-based, eye-tracking training. These data suggest generalizability of training to other cognitive faculties - recall for affective information.",2020,"RESULTS
Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2 = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2 = 0.096).",['Participants with major depressive disorder'],"['active (n\xa0=\xa020) or sham (n\xa0=\xa020) ABM training', 'Attentional bias modification (ABM']","['Attentional bias, memory for emotional words, and mood', 'negative attentional bias']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.153622,"RESULTS
Training reduced negative attentional bias; relative to sham, active training participants focused significantly more on positive compared to negative stimuli in a free-viewing eye-tracker task (p = .038, η p 2 = 0.109) and, at trend, disengaged from sad information more quickly in a computerized task (p = .052, η p 2 = 0.096).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Woolridge', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada.""}, {'ForeName': 'Geoffrey W', 'Initials': 'GW', 'LastName': 'Harrison', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada.""}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Best', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada; Department of Psychological Clinical Science, University of Toronto Scarborough Science Wing, Room SW427D 1265 Military Trail Toronto, Ontaro, M1C 1A4, Canada.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Department of Psychology, Queen's University Humphrey Hall, Room 232 62 Arch Street, Kingston, Ontario, K7L 3L3, Canada. Electronic address: bowiec@queensu.ca.""}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101621']
1583,33202893,Modification of Pronated Foot Posture after a Program of Therapeutic Exercises.,"Working on the intrinsic musculature of the foot has been shown to be effective in controlling pronation. However, the potential coadjuvant effect that involving other muscle groups might have on foot posture remains unknown. The aim was, therefore, to assess whether a 9-week intrinsic and extrinsic foot and core muscle strength program influenced foot posture in pronated subjects. The participants were 36 healthy adults with pronated feet that were randomly assigned to two groups. The experimental group ( n = 18) performed a strengthening exercise protocol for 9 weeks (two sessions of 40 min per week), while the control group ( n = 18) did not do these exercises. After 9 weeks, the foot posture index (FPI) scores of the two groups were analyzed to detect possible changes. The FPI at the baseline was 8.0 ± 1.5. After the 9 weeks, the experimental group showed significantly reduced FPI from 8.1 ± 1.7 to 6.4 ± 2.1 ( p = 0.001), while the control group had the same score as pre-intervention (FPI 8 ± 1.2, p = 1.0). The FPI scores showed no significant differences by sex. Strengthening of the intrinsic and extrinsic foot and core muscles contributed to improving foot posture in adults, reducing their FPI by 1.66 points.",2020,"Strengthening of the intrinsic and extrinsic foot and core muscles contributed to improving foot posture in adults, reducing their FPI by 1.66 points.","['pronated subjects', '36 healthy adults with pronated feet']","['strengthening exercise protocol', '9-week intrinsic and extrinsic foot and core muscle strength program']","['foot posture index (FPI) scores', 'FPI scores']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",36.0,0.0179313,"Strengthening of the intrinsic and extrinsic foot and core muscles contributed to improving foot posture in adults, reducing their FPI by 1.66 points.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Valle-Estévez', 'Affiliation': 'Podiatric Clinic Las Lomas, Avda Salinera 6L-6K, 19005 Guadalajara, Spain.'}, {'ForeName': 'Peñas Albas', 'Initials': 'PA', 'LastName': 'Fraile-García', 'Affiliation': 'Physiotherapy Clinic PAFG, Tenerías 4, 10610 Cabezuela del Valle, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Martínez-Nova', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Gómez-Martín', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Escamilla-Martínez', 'Affiliation': 'Nursing Department, Podiatric Clinic of University of Extremadura CPUEX, 10600 Plasencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228406']
1584,33202916,Point-of-Decision Prompts Increase Dietary Fiber Content of Consumers' Food Choices in an Online Grocery Shopping Simulation.,"Only 5% of Americans consume the recommended amount of dietary fiber. In an online simulated shopping experiment, we examined whether a fiber-focused point-of-decision prompt (PDP) would influence consumers to choose food products that were higher in this important nutrient. We hypothesized that participants exposed to the dietary fiber PDP would choose products with more dietary fiber/serving than those who were not exposed to the PDP. The experiment was completed by 753 participants. Participants were randomly assigned to a condition in which they were not exposed to a PDP (the no-PDP condition), a personalized PDP, or PDP without personalization. Choices in the two PDP conditions were not significantly different. Therefore, the PDP conditions were pooled together into one condition and compared with control participants that did not receive the fiber-focused PDP. Across the three product categories, participants in the PDP condition chose products that had a greater amount of dietary fiber/serving (cereal: 22% increase; bread: 22% increase; crackers: 26% increase; p < 0.01) and products that had a greater healthiness rating (cereals (odds ratio (OR): 1.45, 95% confidence interval (95% CI): (1.10, 1.92)), bread (OR: 1.44, 95% CI: (1.09, 1.91)), and crackers (OR: 1.66, 95% CI: (1.25, 2.21)). Overall, the fiber PDP influenced participants to choose healthier products that contained greater amounts of dietary fiber.",2020,Choices in the two PDP conditions were not significantly different.,['753 participants'],"['personalized PDP, or PDP without personalization', 'fiber-focused point-of-decision prompt (PDP']",[],[],"[{'cui': 'C0761024', 'cui_str': '5,10,15,20-tetrakis(2-N-methylpyridyl)porphyrinatopalladium(II)'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]",[],,0.0325048,Choices in the two PDP conditions were not significantly different.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Arslain', 'Affiliation': 'Department of Food Science and Technology, Institute of Agriculture and Natural Resources, University of Nebraska-Lincoln, Lincoln, NE 68588, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Gustafson', 'Affiliation': 'Department of Agricultural Economics, Institute of Agriculture and Natural Resources, University of Nebraska-Lincoln, Lincoln, NE 68583, USA.'}, {'ForeName': 'Devin J', 'Initials': 'DJ', 'LastName': 'Rose', 'Affiliation': 'Department of Food Science and Technology, Institute of Agriculture and Natural Resources, University of Nebraska-Lincoln, Lincoln, NE 68588, USA.'}]",Nutrients,['10.3390/nu12113487']
1585,33202928,"A Randomized Controlled Trial Investigating the Effects of Equine Simulator Riding on Low Back Pain, Morphological Changes, and Trunk Musculature in Elderly Women.","Background and objectives: Studies on the effects of an equine riding simulator (ERS) program on back pain, spinal alignment, and isokinetic moments in subjects with chronic low back pain (CLBP) remain limited. The purpose of this study was to analyze changes in elderly women with CLBP who participate in an ERS program. Materials and Methods: The 80 participants were all women aged 61-84 years who were randomly assigned to either the control group (CON) or ERS group (ERSG). ERS exercise was performed for a duration of 12 weeks (three times each week). The degree of pain was measured using the Oswestry Disability Index and the visual analog scale. Body composition and spinal alignment were measured using bioelectrical impedance and raster stereography. The isokinetic moments of trunk extensor and flexor were measured before and after the training period. Results: The ERSG showed a significant decrease in back pain compared to the CON. There was a significant decrease in levels of fat in the ERSG, although no differences were shown in terms of muscle mass. However, there was an increased basal metabolic rate (BMR) in the ERSG. Spinal alignment in the ERSG significantly improved. The peak torques of the trunk extensor in the ERSG were also significantly increased. Conclusion: It can be inferred that the ERS exercise can decrease fat and improve the trunk extensor strength through increased BMR, leading to better spinal alignment and reducing back pain in elderly women with CLBP.",2020,"There was a significant decrease in levels of fat in the ERSG, although no differences were shown in terms of muscle mass.","['subjects with chronic low back pain (CLBP', 'Elderly Women', 'elderly women with CLBP who participate in an ERS program', '80 participants were all women aged 61-84 years', 'elderly women with CLBP']","['Equine Simulator Riding', 'control group (CON) or ERS group (ERSG', 'ERS exercise', 'equine riding simulator (ERS) program']","['isokinetic moments of trunk extensor and flexor', 'Low Back Pain, Morphological Changes, and Trunk Musculature', 'levels of fat in the ERSG', 'Body composition and spinal alignment', 'Oswestry Disability Index and the visual analog scale', 'degree of pain', 'back pain', 'basal metabolic rate (BMR', 'peak torques of the trunk extensor in the ERSG', 'back pain, spinal alignment, and isokinetic moments']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0678121', 'cui_str': 'Basal metabolic rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",80.0,0.0316717,"There was a significant decrease in levels of fat in the ERSG, although no differences were shown in terms of muscle mass.","[{'ForeName': 'Sihwa', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Sunhee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Min', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}, {'ForeName': 'Chang-Ju', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'Department of Physiology, College of Medicine, Kyung Hee University, Seoul 02447, Korea.'}, {'ForeName': 'Yong-Seok', 'Initials': 'YS', 'LastName': 'Jee', 'Affiliation': 'Research Institute of Sports and Industry Science, Hanseo University, Seosan 31962, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110610']
1586,33203003,Isoflavone Supplementation Does Not Potentiate the Effect of Combined Exercise Training on Resting and Ambulatory Blood Pressure in Non-Obese Postmenopausal Women: A Randomized Double-Blind Controlled Trial-A Pilot Study.,"Physical exercise and isoflavone supplementation are potential strategies to prevent and treat cardiovascular diseases in postmenopausal women. The aim of this study was to investigate whether there are additive effects of isoflavone supplementation when associated with combined aerobic and resistance exercise on resting and ambulatory blood pressure monitoring (ABPM) and in blood pressure variability (BPV). Thirty-one non-obese postmenopausal women were randomly allocated into two groups: placebo and exercise (Placebo n = 19); and isoflavone supplementation (100 mg/day) and exercise (isoflavone n = 19). ABPM and BPV were evaluated before and after 10 weeks of moderate combined (aerobic and resistance) exercise training. Generalized Estimating Equation (GEE) with Bonferroni correction and intention-to-treat analysis was used to compare the effects of interventions on resting BP, ABPM and BPV. Combined exercise training decreased resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time, with no additional effects of isoflavone supplementation. No changes were observed in sleep period, or in BPV indexes (Standard Deviation of 24 h (SD), daytime and nighttime interval (SDdn) and average real variability (ARV) in both groups. We conclude that isoflavone supplementation does not potentiate the effects of combined training on resting and ambulatorial systolic and diastolic blood pressure in non-obese postmenopausal women.",2020,"Combined exercise training decreased resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time, with no additional effects of isoflavone supplementation.","['non-obese postmenopausal women', 'Non-Obese Postmenopausal Women', 'Thirty-one non-obese postmenopausal women', 'postmenopausal women']","['isoflavone supplementation', 'Physical exercise and isoflavone supplementation', 'moderate combined (aerobic and resistance) exercise training', 'combined aerobic and resistance exercise', 'placebo and exercise (Placebo n = 19); and isoflavone supplementation (100 mg/day) and exercise (isoflavone n = 19', 'Combined exercise training', 'Isoflavone Supplementation', 'Combined Exercise Training']","['resting and ambulatory blood pressure monitoring (ABPM', 'sleep period, or in BPV indexes (Standard Deviation of 24 h (SD), daytime and nighttime interval (SDdn) and average real variability (ARV', 'blood pressure variability (BPV', 'resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time', 'resting and ambulatorial systolic and diastolic blood pressure', 'ABPM and BPV', 'Resting and Ambulatory Blood Pressure', 'resting BP, ABPM and BPV']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450355', 'cui_str': '31'}]","[{'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0006072', 'cui_str': 'Bovine papillomavirus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}]",,0.123019,"Combined exercise training decreased resting systolic (SBP) and diastolic blood pressure (DBP) and reduced 24 h and awake ambulatory SBP, DBP and mean blood pressure over time, with no additional effects of isoflavone supplementation.","[{'ForeName': 'Juliene G C', 'Initials': 'JGC', 'LastName': 'Dechichi', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Igor M', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Jéssica S', 'Initials': 'JS', 'LastName': 'Giolo', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Jaqueline P', 'Initials': 'JP', 'LastName': 'Batista', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}, {'ForeName': 'Paula A B', 'Initials': 'PAB', 'LastName': 'Ribeiro', 'Affiliation': 'Research Center of University of Montreal Hospital Centre, Montreal, QC H2X 0A9, Canada.'}, {'ForeName': 'Erick P', 'Initials': 'EP', 'LastName': 'de Oliveira', 'Affiliation': 'Laboratory of Nutrition, Exercise and Health (LaNES), School of Medicine, Federal University of Uberlandia (UFU), 38402-022 Uberlândia, MG, Brazil.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': 'Laboratory of Cardiorespiratory and Metabolic Physiology, Physical Education and Physical Therapy Department, Federal University of Uberlândia, 38400-678 Uberlândia, MG, Brazil.'}]",Nutrients,['10.3390/nu12113495']
1587,33203008,"Potato Fibers Have Positive Effects on Subjective Appetite Sensations in Healthy Men, but Not on Fecal Fat Excretion: A Randomized Controlled Single-Blind Crossover Trial.","Dietary fibers can affect appetite and gut metabolism, but the effect of the novel potato fibers FiberBind and rhamnogalacturonan I (RG-I) is unknown. We, therefore, aimed to investigate the effect of daily intake of FiberBind and RG-I on appetite sensations and fecal fat excretion. In a single-blinded, randomized, three-way crossover trial, wheat buns with FiberBind, RG-I, or low fiber (control) were consumed by 18 healthy men during a 21-day period. Appetite sensation and blood samples during a 3 h meal test, fecal fat content, and ad libitum energy intake were assessed after each period. Compared to RG-I and control, FiberBind caused a higher composite satiety score (6% ± 2% and 5% ± 2%), lower prospective food consumption (5% ± 2% and 6% ± 2%), and lower desire to eat (7% ± 3% and 6% ± 3%) (all p < 0.05). FiberBind also caused higher satiety (6% ± 2%) and fullness (9% ± 3%) compared to RG-I (all p < 0.01). No effects on fecal fat excretion or energy intake were found. The RG-I fiber caused higher postprandial glucose concentration compared to FiberBind ( p < 0.05) and higher insulin concentration at 180 min compared to control ( p < 0.05). Compared to the control, RG-I and FiberBind lowered peak insulin concentration (both p < 0.05) and delayed time to peak for glucose (both p < 0.05). In conclusion, FiberBind intake could be beneficial for appetite regulation, but neither FiberBind nor RG-I affected fecal fat excretion or energy intake.",2020,"Compared to the control, RG-I and FiberBind lowered peak insulin concentration (both p < 0.05) and delayed time to peak for glucose (both p < 0.05).","['Healthy Men', '18 healthy men during a 21-day period']","['FiberBind and RG-I', 'wheat buns with FiberBind, RG-I, or low fiber (control']","['lower prospective food consumption', 'higher satiety', 'Subjective Appetite Sensations', 'Fecal Fat Excretion', 'appetite sensations and fecal fat excretion', 'postprandial glucose concentration', 'delayed time to peak for glucose', 'Appetite sensation and blood samples', 'lower desire to eat', 'fullness', 'composite satiety score', 'higher insulin concentration', 'peak insulin concentration', 'fecal fat content, and ad libitum energy intake', 'fecal fat excretion or energy intake']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0073164', 'cui_str': 'rhamnogalacturonan I'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",18.0,0.0506501,"Compared to the control, RG-I and FiberBind lowered peak insulin concentration (both p < 0.05) and delayed time to peak for glucose (both p < 0.05).","[{'ForeName': 'Tanja Kongerslev', 'Initials': 'TK', 'LastName': 'Thorning', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Christel Johanneson', 'Initials': 'CJ', 'LastName': 'Bertolt', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Mette S', 'Initials': 'MS', 'LastName': 'Nielsen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Raben', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 1958 Frederiksberg C, Denmark.'}]",Nutrients,['10.3390/nu12113496']
1588,33203625,"Efficacy of quadruple regimen with polaprezinc for gastric Helicobacter pylori infection eradication: protocol for a single-centre, single-blind, non-inferiority, randomised clinical trial.","INTRODUCTION
Helicobacter pylori (H. pylori) is the most well-known risk factor for gastric cancer. At present, H. pylori shows varying levels of resistance to different treatments, leading to a lower rate of H. pylori eradication. The aim of this study is to evaluate the efficacy of polaprezinc-containing quadruple therapy (PQT) for the eradication of H. pylori infection and, thus, to provide more evidence to inform the clinical treatment of H. pylori infection in China.
METHODS AND ANALYSIS
This is a single-centre, single-blind, non-inferiority, randomised controlled trial, enrolling 158 patients with H. pylori infection. Patients are randomised (1:1) to the two groups for a 14-day therapy. Treatment group: PQT (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, polaprezinc 75 mg) two times per day; control group: bismuth-containing quadruple therapy (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bismuth potassium citrate 220 mg) two times per day. The primary outcome is the rate of H. pylori eradication. Secondary outcomes are the incidence of adverse events and the gastrointestinal microbiota distribution. The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota.
ETHICS AND DISSEMINATION
This study was approved by the Ethics Committee of Sichuan Cancer Center & Hospital (No. SCCHEC-02-2019-015). Any amendment to the research protocol will be submitted for ethical approval. All participants must provide informed consent. On completion, the results of the study will be published in the appropriate peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ChiCTR1900025800; preresults.",2020,"The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota.
","['Sichuan Cancer Center & Hospital', '158 patients with H. pylori infection']","['PQT (esomeprazole 20\u2009mg, amoxicillin 1\u2009g, clarithromycin 500\u2009mg, polaprezinc 75\u2009mg) two times per day; control group: bismuth-containing quadruple therapy (esomeprazole 20\u2009mg, amoxicillin 1\u2009g, clarithromycin 500\u2009mg, bismuth potassium citrate', 'polaprezinc-containing quadruple therapy (PQT', 'polaprezinc']","['incidence of adverse events and the gastrointestinal microbiota distribution', 'rate of H. pylori eradication']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C1146111', 'cui_str': 'Esomeprazole 20 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0286382', 'cui_str': 'polaprezinc'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbiota'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",158.0,0.0947054,"The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota.
","[{'ForeName': 'Dingkun', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology, Jilin People's Hospital, Jilin, China.""}, {'ForeName': 'Tingyuan', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Qinwen', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'West China School of Public Health/West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Cancer Prevention and Treatment Office, Yanting Cancer Hospital, Mianyang, China.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Cancer Prevention and Treatment Office, Yanting Cancer Hospital, Mianyang, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Cancer Prevention and Treatment Office, Yanting Cancer Hospital, Mianyang, China.'}, {'ForeName': 'Yuqian', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China gw_zhaoyuqian@126.com chenwen@cicams.ac.cn.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China gw_zhaoyuqian@126.com chenwen@cicams.ac.cn.'}]",BMJ open,['10.1136/bmjopen-2020-037182']
1589,33203626,"Effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in patients with COPD, asthma, diabetes mellitus type 2 and heart failure: protocol for a pragmatic clustered quasi-experimental study.","INTRODUCTION
The number of people that have one or multiple condition(s) with a chronic course is rising, which consequently challenges healthcare systems. Healthcare geared to long-term care should focus on patient-centredness, shared decision making and self-management. The Assessment of Burden of Chronic Conditions (ABCC) tool was developed to integrate these elements in daily healthcare practice. The ABCC tool assesses and visualises burden of disease(s), helps to make shared decisions and stimulates self-management. The present paper documents a protocol for a quasi-experimental study investigating the effectiveness and cost-effectiveness of the ABCC tool for people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure.
METHODS AND ANALYSIS
The study has a pragmatic clustered quasi-experimental design and will be conducted in the Netherlands. The intervention will be allocated at the level of general practice. The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care. Outcomes include change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients' activation (Patient Activation Measure) and costs. Follow-up time will be 18 months. Outcomes will be analysed using linear mixed models.
ETHICS AND DISSEMINATION
Ethical approval was obtained from the Medical Ethics Committee Zuyderland-Zuyd Heerlen, the Netherlands (METCZ20180131). Results will be published in peer-reviewed journals and will be presented at national and international conferences.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov Registry (NCT04127383).",2020,"The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care.","['patients with COPD, asthma, diabetes mellitus type 2 and heart failure', 'people with chronic obstructive pulmonary disease, asthma, type 2 diabetes mellitus and/or heart failure']","['ABCC tool', 'ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care']","[""change in quality of care (Patient Assessment of Chronic Illness Care), quality of life (EuroQol-5D-5L), capability well-being (ICEpop CAPability measure for Adults), patients' activation (Patient Activation Measure) and costs"", 'Effectiveness and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0779535,"The intervention group (18 general practices, 180 patients) will use the ABCC tool during regular consultations; the control group (18 general practices, 180 patients) will maintain usual care.","[{'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Boudewijns', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands esther.boudewijns@maastrichtuniversity.nl.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Claessens', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Joore', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment (KEMTA), Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Lotte C E M', 'Initials': 'LCEM', 'LastName': 'Keijsers', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Onno C P', 'Initials': 'OCP', 'LastName': 'van Schayck', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'Annerika H M', 'Initials': 'AHM', 'LastName': 'Gidding-Slok', 'Affiliation': 'Department of Family Medicine, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2020-037693']
1590,33227548,Duration of dual antiplatelet therapy after myocardial infarction: Insights from a pooled database of the SMART-DATE and DAPT-STEMI trials.,"BACKGROUND AND AIMS
The optimal duration of dual antiplatelet therapy (DAPT) after myocardial infarction (MI) in patients treated with second-generation drug-eluting stent (DES) is unclear, therefore, we aim to evaluate the ischemic and bleeding risk according to DAPT duration using a pooled-analysis of two randomized trials.
METHODS
MI patients treated with durable-polymer second-generation DES from two randomized trials, SMART-DATE and DAPT-STEMI, were pooled. The primary endpoint was a composite of net adverse clinical events (NACEs) defined by all-cause mortality, any MI, stroke and BARC 3-5 bleeding, between 6 and 18 months after index percutaneous coronary intervention.
RESULTS
A total of 2016 patients were analyzed, 1014 were treated with 6-month DAPT versus 1002 patients with ≥12-month DAPT duration. The primary endpoint occurred in 2.7% vs 2.5% (HR 1.07; 95%CI 0.62-1.85, p = 0.80) of cases, in 6 vs ≥ 12-month DAPT, respectively. The composite of cardiac death, MI and stroke was similar (2% vs 1.6%, HR 1.24, 95%CI 0.65-2.4, p = 0.52). BARC 3-5 bleeding occurred more frequently in the ≥12-month DAPT (0.2% vs 0.9%, HR 0.22, 95%CI 0.05-1.02 p = 0.05, log rank p = 0.03). MI occurred more frequently in the 6-month DAPT (1.6% vs 0.6%, HR 2.66, 95%CI 1.04-6.79, p = 0.04). Stent thrombosis was similar in both arms (0.7% vs 0.5%, p = 0.26).
CONCLUSIONS
Six vs ≥ 12-month DAPT, followed by aspirin alone, resulted in comparable NACEs in patients with event-free MI at six months after durable-polymer DES implantation. However, single therapy with aspirin beyond the 6 months reduced bleeding rates but was associated with a higher rate of MI compared to ≥12-month DAPT.",2020,"Stent thrombosis was similar in both arms (0.7% vs 0.5%, p = 0.26).
","['A total of 2016 patients were analyzed, 1014 were treated with 6-month DAPT versus 1002 patients with ≥12-month DAPT duration', 'myocardial infarction', 'MI patients treated with durable-polymer second-generation DES from two randomized trials, SMART-DATE and DAPT-STEMI, were pooled', 'patients treated with second-generation drug-eluting stent (DES']","['aspirin', 'dual antiplatelet therapy (DAPT']","['composite of net adverse clinical events (NACEs) defined by all-cause mortality, any MI, stroke and BARC 3-5 bleeding', 'MI', 'BARC 3-5 bleeding', 'bleeding rates', 'Stent thrombosis', 'composite of cardiac death, MI and stroke']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}]",2016.0,0.102911,"Stent thrombosis was similar in both arms (0.7% vs 0.5%, p = 0.26).
","[{'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Kedhi', 'Affiliation': 'Hospital Erasme, Université Libre de Bruxelles, Bruxelles, Belgium. Electronic address: ekedhi@me.com.'}, {'ForeName': 'Ronak', 'Initials': 'R', 'LastName': 'Delewi', 'Affiliation': 'Heart Centre, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fabris', 'Affiliation': 'Cardiovascular Department, University of Trieste, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'Division of Cardiology, Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Renicus S', 'Initials': 'RS', 'LastName': 'Hermanides', 'Affiliation': 'Isala Hartcentrum, Zwolle, the Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van den Ent', 'Affiliation': 'Maasstad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'American Heart of Poland, Ustroń and Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Zijlstra', 'Affiliation': 'Thoraxcenter, Erasmus Medisch Centrum, Rotterdam, the Netherlands.'}, {'ForeName': 'Young Bin', 'Initials': 'YB', 'LastName': 'Song', 'Affiliation': 'Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeon-Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Joo-Yong', 'Initials': 'JY', 'LastName': 'Hahn', 'Affiliation': 'Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.11.003']
1591,33227624,"Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine.","OBJECTIVES
Increasing evidence demonstrates effectiveness of Mindfulness-Based Stress Reduction (MBSR) for pain-related and functional disorders. In order to conduct successful and efficient trials of MBSR, evidence regarding the relative performance of strategies to improve recruitment, retention, and adherence is required, but few studies have examined these issues specifically.
DESIGN
In preparation for a fully powered trial, we conducted a 2-arm, parallel comparison randomized controlled feasibility trial of MBSR vs. usual-care for 60 patients with migraine headache.
SETTING
Two large U.S. health systems in Northern California.
INTERVENTION
MBSR is an 8-week classroom-based intervention that combines mindfulness meditation and yoga, with didactic presentations about stress psychology and group process/experiential education. Participants received the intervention at their choice of one of several existing, vetted community-based classes.
MAIN OUTCOME MEASURES
Successful recruitment was defined a priori as 18 participants within any 9-week period or 60 participants enrolled within a 36-week period. We considered participants adherent to the intervention if they attended at least 5 of the 8 weekly classes and the day-long retreat.
RESULTS
We successfully enrolled 18 participants within a 7-week period, however, we did not attain our second goal of recruiting 60 participants within a 36-week period. Sixty-eight percent of our participants were adherent to the intervention.
CONCLUSIONS
We found that close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the delivery system were crucial factors for successful participant recruitment, retention, and adherence in mindfulness research.",2020,"OBJECTIVES
Increasing evidence demonstrates effectiveness of Mindfulness-Based Stress Reduction (MBSR) for pain-related and functional disorders.","['60 patients with migraine headache', 'patients with migraine', 'pain-related and functional disorders', '18 participants within a 7-week period, however, we did not attain our second goal of recruiting 60 participants within a 36-week period', 'Two large U.S. health systems in Northern California']","['Mindfulness-Based Stress Reduction (MBSR', 'MBSR', 'mindfulness meditation and yoga, with didactic presentations about stress psychology and group process/experiential education', 'MBSR vs. usual-care', 'mindfulness-based stress reduction']","['Recruitment, retention, and adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0277785', 'cui_str': 'Functional disorder'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0018265', 'cui_str': 'Group Process'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",18.0,0.0877653,"OBJECTIVES
Increasing evidence demonstrates effectiveness of Mindfulness-Based Stress Reduction (MBSR) for pain-related and functional disorders.","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Law', 'Affiliation': 'Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Avins', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, 2000 Broadway, Oakland, CA 94612, United States; University of California San Francisco, Department of Epidemiology and Biostatistics, San Francisco, CA, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stahl', 'Affiliation': 'Insight Santa Cruz a Buddhist Meditation Community, 119 Marnell Avenue, Santa Cruz, CA 95062, United States.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Goodreau', 'Affiliation': 'Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Jacobson', 'Affiliation': 'Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Sudat', 'Affiliation': 'Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Pressman', 'Affiliation': 'Sutter Health Research Development and Dissemination, 2121 North California Boulevard, Suite 310, Walnut Creek, CA 94596, United States; University of California San Francisco, Department of Epidemiology and Biostatistics, San Francisco, CA, United States. Electronic address: pressmar@sutterhealth.org.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102610']
1592,33227646,The influence of DHA supplementation during pregnancy on language development across childhood: Follow-up of a randomised controlled trial.,"Numerous randomised controlled trials have explored the effect of docosahexaenoic acid (DHA) supplementation in early life on neurodevelopment, with some suggested positive effects on language. Australian women with a singleton pregnancy <21 weeks' gestation were randomised to receive 800 mg DHA/day or a placebo until birth. A sample of 726 children (all n=96 born preterm, random sample of n=630 born at term) were invited to undergo assessments of language, academic, and language-based cognitive abilities at 1.5, four and seven years of age. No group differences were detected for any group comparison. Exploratory analyses for sex by treatment interactions revealed a possible adverse effect of DHA supplementation on the language of females at 1.5 years but no effects on outcomes at four or seven years. Taken as a whole, evidence of an effect of prenatal DHA supplementation on language abilities across childhood is negligible and could be a chance finding.",2020,Australian women with a singleton pregnancy <21 weeks' gestation were randomised to receive 800 mg DHA/day or a placebo until birth.,"[""Australian women with a singleton pregnancy <21 weeks' gestation"", '726 children (all n=96 born preterm, random sample of n=630 born at term) were invited to undergo assessments of language, academic, and language-based cognitive abilities at 1.5, four and seven years of age']","['placebo', 'prenatal DHA supplementation', 'DHA supplementation', 'docosahexaenoic acid (DHA) supplementation']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],726.0,0.374212,Australian women with a singleton pregnancy <21 weeks' gestation were randomised to receive 800 mg DHA/day or a placebo until birth.,"[{'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Gawlik', 'Affiliation': 'Discipline of Paediatrics, Faculty of Health and Medical Sciences, The University of Adelaide, North Terrace Adelaide, South Australia, 5000. Electronic address: nr.gawlik@rasa.org.au.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'Discipline of Paediatrics, Faculty of Health and Medical Sciences, The University of Adelaide, North Terrace Adelaide, South Australia, 5000; Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, South Australia, 5006. Electronic address: maria.makrides@sahmri.com.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Kettler', 'Affiliation': 'Trinity College Gawler Inc, Alexander Avenue, Evanston South SA 5116; School of Psychology, The University of Adelaide, North Terrace Adelaide, South Australia, 5000. Electronic address: kettleli@trinity.sa.edu.au.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, South Australia, 5006; School of Public Health, Faculty of Health and Medical Sciences, The University of Adelaide, North Terrace Adelaide, South Australia, 5000. Electronic address: lisa.yelland@adelaide.edu.au.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, South Australia, 5006. Electronic address: shalem.leemaqz@sahmri.com.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Gould', 'Affiliation': 'Women and Kids, South Australian Health and Medical Research Institute, 72 King William Road, North Adelaide, South Australia, 5006; School of Psychology & Discipline of Paediatrics, Faculty of Health and Medical Sciences, The University of Adelaide, North Terrace Adelaide, South Australia, 5000. Electronic address: jacqueline.gould@sahmri.com.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102207']
1593,33228236,Effects of Multiple Sessions of Cathodal Priming and Anodal HD-tDCS on Visuo Motor Task Plateau Learning and Retention.,"A single session of priming cathodal transcranial direct current stimulation (tDCS) prior to anodal tDCS (c-a-tDCS) allows cumulative effects on motor learning and retention. However, the impact of multiple sessions of c-a-tDCS priming on learning and retention remains unclear. Here, we tested whether multiple sessions of c-a-tDCS (over 3 consecutive days) applied over the left sensorimotor cortex can further enhance motor learning and retention of an already learned visuo-motor task as compared to anodal tDCS (a-tDCS) or sham. In a between group and randomized double-blind sham-controlled study design, 25 participants separated in 3 independent groups underwent 2 days of baseline training without tDCS followed by 3-days of training with both online and offline tDCS, and two retention tests (1 and 14 days later). Each training block consisted of five trials of a 60 s circular-tracing task intersected by 60 s rest, and performance was assessed in terms of speed-accuracy trade-off represented notably by an index of performance (IP). The main findings of this exploratory study were that multiple sessions of c-a-tDCS significantly further enhanced IP above baseline training levels over the 3 training days that were maintained over the 2 retention days, but these learning and retention performance changes were not significantly different from the sham group. Subtle differences in the changes in speed-accuracy trade-off (components of IP) between c-a-tDCS (maintenance of accuracy over increasing speed) and a-tDCS (increasing speed over maintenance of accuracy) provide preliminary insights to a mechanistic modulation of motor performance with priming and polarity of tDCS.",2020,Subtle differences in the changes in speed-accuracy trade-off (components of IP) between c-a-tDCS (maintenance of accuracy over increasing speed) and a-tDCS (increasing speed over maintenance of accuracy) provide preliminary insights to a mechanistic modulation of motor performance with priming and polarity of tDCS.,['25 participants separated in 3 independent groups underwent 2 days of'],"['anodal tDCS (a-tDCS) or sham', 'Cathodal Priming and Anodal HD-tDCS', 'cathodal transcranial direct current stimulation (tDCS) prior to anodal tDCS (c-a-tDCS', 'baseline training without tDCS followed by 3-days of training with both online and offline tDCS']","['learning and retention performance changes', 'Visuo Motor Task Plateau Learning and Retention']","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",25.0,0.0936788,Subtle differences in the changes in speed-accuracy trade-off (components of IP) between c-a-tDCS (maintenance of accuracy over increasing speed) and a-tDCS (increasing speed over maintenance of accuracy) provide preliminary insights to a mechanistic modulation of motor performance with priming and polarity of tDCS.,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Besson', 'Affiliation': 'EuroMov Digital Health in Motion, Univ Montpellier, IMT Mines Ales, 34090 Montpellier, France.'}, {'ForeName': 'Makii', 'Initials': 'M', 'LastName': 'Muthalib', 'Affiliation': 'EuroMov Digital Health in Motion, Univ Montpellier, IMT Mines Ales, 34090 Montpellier, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'De Vassoigne', 'Affiliation': 'EuroMov Digital Health in Motion, Univ Montpellier, IMT Mines Ales, 34090 Montpellier, France.'}, {'ForeName': 'Jonh', 'Initials': 'J', 'LastName': 'Rothwell', 'Affiliation': 'Institute of Neurology, University College London, London WC1N 3BG, UK.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Perrey', 'Affiliation': 'EuroMov Digital Health in Motion, Univ Montpellier, IMT Mines Ales, 34090 Montpellier, France.'}]",Brain sciences,['10.3390/brainsci10110875']
1594,33228572,MINISTOP 2.0: a smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours and prevent obesity in preschool-aged children: protocol for a hybrid design effectiveness-implementation study.,"BACKGROUND
Childhood obesity is still a major health problem in many countries, including Sweden. Childhood obesity and obesity-related behaviours in childhood, such as low physical activity and unhealthy eating habits, tend to track into adulthood, which highlights the need for early prevention. Our aims are to evaluate whether a parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours and reduce the prevalence of overweight and obesity in preschool-aged children as well as to evaluate the implementation among child health care nurses and parents.
METHODS
This trial uses a hybrid type 1 effectiveness-implementation design. Families (n = 500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5 years, are offered participation in a randomised controlled trial (effectiveness evaluation). After acceptance, families will be randomised (1:1) to control or intervention groups. The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care. Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes) are measured at baseline and at 6 months post randomisation. Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility) of the intervention will be assessed among primary child health care nurses and parents in the trial through questionnaires and qualitative interviews.
DISCUSSION
This trial will evaluate whether the MINISTOP 2.0 app can be used in primary child health care to improve diet and physical activity behaviours, and prevent overweight and obesity, in preschool-aged children. If effectiveness is proven, and the MINISTOP 2.0 app is considered acceptable, appropriate and feasible, it can be implemented nationally as part of the preventive strategies to combat childhood obesity provided by routine child health care.
TRIAL REGISTRATION
The trial was registered at the Clinicaltrials.gov register platform (ID NCT04147039 ) on 31 October 2019.",2020,The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care.,"['child health care nurses and parents', 'Families (n\u2009=\u2009500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5\u2009years', 'preschool-aged children']","['smartphone app integrated in primary child health care to promote healthy diet and physical activity behaviours', 'parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours', '6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care']","['Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility', 'Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes']","[{'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0635147,The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care.,"[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Henriksson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden. hanna.henriksson@liu.se.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Alexandrou', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Henriksson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Henström', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, 141 83 Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Müssener', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, 581 83, Linköping, Sweden.'}]",BMC public health,['10.1186/s12889-020-09808-w']
1595,32691272,Student Knowledge Gain Following the Second Step Child Protection Unit: the Influence of Treatment Integrity.,"Treatment integrity is an important yet understudied component of school-based prevention programming, particularly for sensitive topics such as child sexual abuse prevention (CSA). This study examined student- and teacher-level characteristics, including components of treatment integrity, that contributed to greater knowledge gain among students participating in the Second Step Child Protection Unit (CPU). The study was conducted with 1132 students and 57 teachers from four elementary schools enrolled in a randomized controlled trial of the CPU. Students were administered assessments at pre-test, post-test, 6-month follow-up, and 12-month follow-up. Teachers were observed and rated on Content Integrity (CI; adherence to content), Process Integrity (PI; teacher enthusiasm, encouragement, behavior management), and Dose Received (DR; student behavior and interest) when delivering the lessons. Hierarchical linear growth modeling indicated that students who received the CPU made gains in the knowledge of CSA concepts and skills over a 12-month follow-up period. Girls had significantly greater CSA knowledge than boys immediately after the intervention, with gender remaining significant even when accounting for level-3 variables. Older children had better knowledge scores at post-test, but growth over time results revealed that younger students made greater gains. For students in 2nd through 4th grade, CI was more important for post-test outcomes, while for all students, CI and grade taught were important to post-test scores. Teachers of lower grades had students with a faster growth rate on correct responses to vignettes. Implications for CSA prevention programming and future research are discussed.",2020,"Older children had better knowledge scores at post-test, but growth over time results revealed that younger students made greater gains.","['Older children', '1132 students and 57 teachers from four elementary schools enrolled', 'students participating in the Second Step Child Protection Unit (CPU']",['CPU'],"['Student Knowledge Gain', 'knowledge scores', 'CSA knowledge', 'Content Integrity (CI; adherence to content), Process Integrity (PI; teacher enthusiasm, encouragement, behavior management), and Dose Received (DR; student behavior and interest']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0337542', 'cui_str': 'Stepchild'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0424090', 'cui_str': 'Level of interest'}, {'cui': 'C0150143', 'cui_str': 'Behavior management'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0543488', 'cui_str': 'Interested'}]",1132.0,0.0133982,"Older children had better knowledge scores at post-test, but growth over time results revealed that younger students made greater gains.","[{'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Manges', 'Affiliation': 'Alberti Center for Bullying Abuse Prevention, The University at Buffalo, State University of New York, 428 Baldy Hall, Buffalo, NY, 14260-1000, USA. memanges@buffalo.edu.'}, {'ForeName': 'Amanda B', 'Initials': 'AB', 'LastName': 'Nickerson', 'Affiliation': 'Alberti Center for Bullying Abuse Prevention, The University at Buffalo, State University of New York, 428 Baldy Hall, Buffalo, NY, 14260-1000, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01146-y']
1596,32692299,Two-year Review on Mortality and Morbidity after Femoropopliteal Drug-coated Balloon Angioplasty in the Randomized EffPac Trial.,,2020,,[],['Femoropopliteal Drug-coated Balloon Angioplasty'],['Mortality and Morbidity'],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0892218,,"[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Aschenbach', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Thieme', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beschorner', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Dierk', 'Initials': 'D', 'LastName': 'Scheinert', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}]",Radiology,['10.1148/radiol.2020201370']
1597,33210382,A Phase Ib Study of NUC-1031 in Combination with Cisplatin for the First-Line Treatment of Patients with Advanced Biliary Tract Cancer (ABC-08).,"BACKGROUND
Cisplatin/gemcitabine is standard first-line treatment for patients with advanced biliary tract cancer (ABC). NUC-1031 (phosphoramidate transformation of gemcitabine) is designed to enhance efficacy by maximizing intratumoral active metabolites.
METHODS
Patients with untreated ABC, Eastern Cooperative Oncology Group performance status 0-1 received NUC-1031 (625 or 725 mg/m 2 ) and cisplatin (25 mg/m 2 ) on days 1 and 8, every 21 days. Primary objectives were safety and maximum tolerated dose; secondary objectives were objective response rate (ORR), pharmacokinetics, progression-free survival (PFS), and overall survival (OS).
RESULTS
Twenty-one patients (median age 61 years, n = 13 male; 17 cholangiocarcinoma, 2 ampullary, and 2 gallbladder cancer) received NUC-1031 625 mg/m 2 (n = 8 and expansion n = 7; median six cycles) or 725 mg/m 2 (n = 6; median 7.5 cycles). Treatment was well tolerated; most common treatment-emergent grade 3-4 adverse events occurring in more than one patient with 625 mg/m 2 NUC-1031 were increased gamma-glutamyl transferase (GGT), 40%; alanine aminotransferase, 20%; bilirubin, 13%; neutropenia, 27%; decreased white cell count, 20%; thrombocytopenia, 13%; nausea, 13%; diarrhea, 13%; fatigue, 13%; and thrombus, 20% and with 725 mg/m 2 , increased GGT, 67%, and fatigue, 33%. NUC-1031 725 mg/m 2 was selected as the recommended dose with cisplatin in ABC. ORR was 33% (one complete response, six partial responses), DCR was 76%, median PFS was 7.2 months (95% confidence interval [CI], 4.3-10.1), and median OS was 9.6 months (95% CI, 6.7-13.1). The median estimates of area under the plasma concentration-time curve from time 0 to last measurable time and maximum concentration were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for di-fluoro-deoxycytidine (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively).
CONCLUSION
This is the first study reporting on the combination of NUC-1031 with cisplatin in ABC and demonstrated a favorable safety profile; 725 mg/m 2 NUC-1031 in combination with cisplatin is undergoing phase III trial evaluation in ABC. (ClinicalTrials.gov ID: NCT02351765; EudraCT ID: 2015-000100-26).
IMPLICATIONS FOR PRACTICE
The prognosis for patients with advanced biliary tract cancer (ABC) is approximately 1 year, and new treatment options are required. The cisplatin/gemcitabine combination is standard first-line treatment for patients with ABC. NUC-1031 is a phosphoramidate transformation of gemcitabine and is designed to enhance efficacy by maximizing intratumoral active metabolites. This phase Ib study (ABC-08) demonstrated a favorable safety profile of NUC-1031 in combination with cisplatin for the first-line treatment of patients with ABC, and 725 mg/m 2 NUC-1031 was recommended in combination with cisplatin for phase III trial evaluation; the NuTide:121 global randomized study is currently enrolling.",2020,"The median plasma AUC 0-24 and C max estimates were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for dFdC (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively).
","['Twenty-one patients (median age 61\u2009years, n=13 male; 17 cholangiocarcinoma, 2 ampullary and 2 gallbladder cancer', 'patients with ABC', 'patients with ABC, and 725mg', 'patients with advanced biliary tract cancer (ABC', 'patients with advanced biliary tract cancer (ABC-08', 'Patients with untreated ABC, ECOG-PS 0-1 received']","['NUC-1031 with cisplatin', 'Cisplatin/gemcitabine', 'NUC-1031 (phosphoramidate transformation of gemcitabine', 'cisplatin/gemcitabine', 'cisplatin', 'ORR', 'NUC-1031', 'gemcitabine', 'NUC-1031 ', 'EudraCT']","['diarrhea', 'ORR, pharmacokinetics, PFS and OS (secondary', 'nausea', 'median plasma AUC 0-24 and C max estimates', 'tolerated', 'neutropenia']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0153452', 'cui_str': 'Malignant tumor of gallbladder'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}]","[{'cui': 'C3640933', 'cui_str': 'NUC-1031'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0896246', 'cui_str': 'phosphoramidate'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",,0.0445132,"The median plasma AUC 0-24 and C max estimates were highest for NUC-1031 (218-324 μg•h/mL and 309-889 μg/mL, respectively) and lowest for dFdC (0.47-1.56 μg•h/mL and 0.284-0.522 μg/mL, respectively).
","[{'ForeName': 'Mairéad G', 'Initials': 'MG', 'LastName': 'McNamara', 'Affiliation': 'Division\u2009of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'University College London, London, United Kingdom.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'Clatterbridge Cancer Centre and Liverpool Experimental Cancer Medicine Centre, Liverpool, United Kingdom.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'Clatterbridge Cancer Centre and Liverpool Experimental Cancer Medicine Centre, Liverpool, United Kingdom.'}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Alkesh', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Department of Pharmacy, The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Ryder', 'Affiliation': 'Manchester Clinical Trials Unit, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Safia', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Manchester Clinical Trials Unit, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Chathunissa', 'Initials': 'C', 'LastName': 'Gnanaranjan', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Essam', 'Initials': 'E', 'LastName': 'Ghazaly', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'T R Jeff', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, United Kingdom.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'Division\u2009of Cancer Sciences, University of Manchester, Manchester, United Kingdom.'}]",The oncologist,['10.1002/onco.13598']
1598,33210434,Identification of novel step-up regimen of intralesional triamcinolone acetonide in scalp alopecia areata based on a double-blind randomized controlled trial.,"Although intralesional triamcinolone acetonide (TA) is the most commonly prescribed treatment for localized alopecia areata (AA), the literature regarding the optimal concentration for attaining better efficacy with the most acceptable side effects is scarce. To compare hair regrowth and local side effects of various concentrations of intralesional TA in scalp AA using clinical and dermoscopic parameters. A double-blind randomized control trial with four treatment groups (10, 5, 2.5 mg/ml TA and normal saline [NS]) was conducted between March 2018 and August 2019. After recruitment, each AA patch was divided into quadrants and randomized before first injection. Injections were given and outcome parameters were analyzed every 4-weekly till 12-weeks. Statistical analysis was done by the R software employing generalized estimation equation. P-value <.05 was considered significant. Out of 105-patients (168-AA patches), 75-patients (121-patches) completed the study. Hair regrowth scale of all TA concentrations was better than NS group (P < .001). Other parameters such as quadrants with poor clinical response and dermoscopic disease activity signs were also favorable in TA groups in comparison to NS. However the evidence of atrophy and telangiectasia was maximum in 10 mg/mL group. 10 mg/mL TA showed a comparatively better response at the cost of increased adverse effects. Based on the clinical benefit and adverse risk assessment from our study, it may be better to start with 2.5 mg/mL intralesional TA in limited scalp AA patients. It can be implied that the concentration of TA can be increased as a step-up regimen based on the serial clinical and dermoscopic response.",2020,Hair regrowth scale (RGS) of all TA concentrations were better than NS group (p<0.001).,['scalp alopecia areata'],"['intralesional triamcinolone acetonide', 'intralesional triamcinolone acetonide(TA', '10-mg/ml, 5-mg/ml, 2.5-mg/ml TA and normal saline (NS', 'intralesional TA']","['atrophy and telangiectasia', 'clinical response and dermoscopic disease activity signs', 'Hair regrowth scale (RGS) of all TA concentrations', 'adverse effects']","[{'cui': 'C0574769', 'cui_str': 'Loss of scalp hair'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0039446', 'cui_str': 'Telangiectasis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.332477,Hair regrowth scale (RGS) of all TA concentrations were better than NS group (p<0.001).,"[{'ForeName': 'Bandhala', 'Initials': 'B', 'LastName': 'Rajan M', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Budania', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Bains', 'Affiliation': 'Department of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Thirunavukkarasu', 'Affiliation': 'Department of Community Medicine and Family Medicine, All India Institute of Medical Sciences, Jodhpur, India.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Kumar-M', 'Affiliation': 'Department of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Dermatologic therapy,['10.1111/dth.14555']
1599,33210751,Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus.,"BACKGROUND
The term prediabetes is used to describe a population with an elevated risk of developing type 2 diabetes mellitus (T2DM). With projections of an increase in the incidence of T2DM, prevention or delay of the disease and its complications is paramount. It is currently unknown whether pioglitazone is beneficial in the treatment of people with increased risk of developing T2DM.
OBJECTIVES
To assess the effects of pioglitazone for prevention or delay of T2DM and its associated complications in people at risk of developing T2DM.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Chinese databases, ICTRP Search Portal and ClinicalTrials.gov. We did not apply any language restrictions. Further, we investigated the reference lists of all included studies and reviews. We tried to contact all study authors. The date of the last search of databases was November 2019 (March 2020 for Chinese databases).
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with a minimum duration of 24 weeks, and participants diagnosed with intermediate hyperglycaemia with no concomitant diseases, comparing pioglitazone as monotherapy or part of dual therapy with other glucose-lowering drugs, behaviour-changing interventions, placebo or no intervention.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened abstracts, read full-text articles and records, assessed risk of bias and extracted data. We performed meta-analyses with a random-effects model and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, with 95% confidence intervals (CIs) for effect estimates. We evaluated the certainty of the evidence with the GRADE.
MAIN RESULTS
We included 27 studies with a total of 4186 randomised participants. The size of individual studies ranged between 43 and 605 participants and the duration varied between 6 and 36 months. We judged none of the included studies as having low risk of bias across all 'Risk of bias' domains. Most studies identified people at increased risk of T2DM by impaired fasting glucose or impaired glucose tolerance (IGT), or both. Our main outcome measures were all-cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, nonfatal myocardial infarction or stroke (NMI/S), health-related quality of life (QoL) and socioeconomic effects. The following comparisons mostly reported only a fraction of our main outcome set. Three studies compared pioglitazone with metformin. They did not report all-cause and cardiovascular mortality, NMI/S, QoL or socioeconomic effects. Incidence of T2DM was 9/168 participants in the pioglitazone groups versus 9/163 participants in the metformin groups (RR 0.98, 95% CI 0.40 to 2.38; P = 0.96; 3 studies, 331 participants; low-certainty evidence). No SAEs were reported in two studies (201 participants; low-certainty evidence). One study compared pioglitazone with acarbose. Incidence of T2DM was 1/50 participants in the pioglitazone group versus 2/46 participants in the acarbose group (very low-certainty evidence). No participant experienced a SAE (very low-certainty evidence).One study compared pioglitazone with repaglinide. Incidence of T2DM was 2/48 participants in the pioglitazone group versus 1/48 participants in the repaglinide group (low-certainty evidence). No participant experienced a SAE (low-certainty evidence). One study compared pioglitazone with a personalised diet and exercise consultation. All-cause and cardiovascular mortality, NMI/S, QoL or socioeconomic effects were not reported. Incidence of T2DM was 2/48 participants in the pioglitazone group versus 5/48 participants in the diet and exercise consultation group (low-certainty evidence). No participant experienced a SAE (low-certainty evidence). Six studies compared pioglitazone with placebo. No study reported on QoL or socioeconomic effects. All-cause mortality was 5/577 participants the in the pioglitazone groups versus 2/579 participants in the placebo groups (Peto odds ratio 2.38, 95% CI 0.54 to 10.50; P = 0.25; 4 studies, 1156 participants; very low-certainty evidence). Incidence of T2DM was 80/700 participants in the pioglitazone groups versus 131/695 participants in the placebo groups (RR 0.40, 95% CI 0.17 to 0.95; P = 0.04; 6 studies, 1395 participants; low-certainty evidence). There were 3/93 participants with SAEs in the pioglitazone groups versus 1/94 participants in the placebo groups (RR 3.00, 95% CI 0.32 to 28.22; P = 0.34; 2 studies, 187 participants; very low-certainty evidence). However, the largest study for this comparison did not distinguish between serious and non-serious adverse events. This study reported that 121/303 (39.9%) participants in the pioglitazone group versus 151/299 (50.5%) participants in the placebo group experienced an adverse event (P = 0.03). One study observed cardiovascular mortality in 2/181 participants in the pioglitazone group versus 0/186 participants in the placebo group (RR 5.14, 95% CI 0.25 to 106.28; P = 0.29; very low-certainty evidence). One study observed NMI in 2/303 participants in the pioglitazone group versus 1/299 participants in the placebo group (RR 1.97: 95% CI 0.18 to 21.65; P = 0.58; very low-certainty evidence). Twenty-one studies compared pioglitazone with no intervention. No study reported on cardiovascular mortality, NMI/S, QoL or socioeconomic effects. All-cause mortality was 11/441 participants in the pioglitazone groups versus 12/425 participants in the no-intervention groups (RR 0.85, 95% CI 0.38 to 1.91; P = 0.70; 3 studies, 866 participants; very low-certainty evidence). Incidence of T2DM was 60/1034 participants in the pioglitazone groups versus 197/1019 participants in the no-intervention groups (RR 0.31, 95% CI 0.23 to 0.40; P < 0.001; 16 studies, 2053 participants; moderate-certainty evidence). Studies reported SAEs in 16/610 participants in the pioglitazone groups versus 21/601 participants in the no-intervention groups (RR 0.71, 95% CI 0.38 to 1.32; P = 0.28; 7 studies, 1211 participants; low-certainty evidence). We identified two ongoing studies, comparing pioglitazone with placebo and with other glucose-lowering drugs. These studies, with 2694 participants. may contribute evidence to future updates of this review.
AUTHORS' CONCLUSIONS
Pioglitazone reduced or delayed the development of T2DM in people at increased risk of T2DM compared with placebo (low-certainty evidence) and compared with no intervention (moderate-certainty evidence). It is unclear whether the effect of pioglitazone is sustained once discontinued. Pioglitazone compared with metformin neither showed advantage nor disadvantage regarding the development of T2DM in people at increased risk (low-certainty evidence). The data and reporting of all-cause mortality, SAEs, micro- and macrovascular complications were generally sparse. None of the included studies reported on QoL or socioeconomic effects.",2020,Pioglitazone compared with metformin neither showed advantage nor disadvantage regarding the development of T2DM in people at increased risk (low-certainty evidence).,"['participants diagnosed with intermediate hyperglycaemia with no concomitant diseases, comparing', '27 studies with a total of 4186 randomised participants', 'people at risk of developing T2DM']","['pioglitazone as monotherapy or part of dual therapy with other glucose-lowering drugs, behaviour-changing interventions, placebo or no intervention', 'pioglitazone with acarbose', 'pioglitazone with repaglinide', 'metformin', 'repaglinide', 'pioglitazone with placebo and with other glucose-lowering drugs', 'pioglitazone with placebo', 'placebo', 'pioglitazone', 'pioglitazone with metformin', 'acarbose', 'Pioglitazone']","['Incidence of T2DM', 'risk of T2DM by impaired fasting glucose or impaired glucose tolerance (IGT', 'cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, nonfatal myocardial infarction or stroke (NMI/S), health-related quality of life (QoL) and socioeconomic effects', 'cardiovascular mortality', 'QoL or socioeconomic effects', 'cardiovascular mortality, NMI/S, QoL or socioeconomic effects', 'advantage nor disadvantage regarding the development of T2DM', 'All-cause mortality', 'adverse event']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0243087', 'cui_str': 'concomitant disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",4186.0,0.370911,Pioglitazone compared with metformin neither showed advantage nor disadvantage regarding the development of T2DM in people at increased risk (low-certainty evidence).,"[{'ForeName': 'Emil Ørskov', 'Initials': 'EØ', 'LastName': 'Ipsen', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper S', 'Initials': 'KS', 'LastName': 'Madsen', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chi', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Pedersen-Bjergaard', 'Affiliation': 'Department of Cardiology, Nephrology and Endocrinology, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Richter', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Maria-Inti', 'Initials': 'MI', 'LastName': 'Metzendorf', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Hemmingsen', 'Affiliation': 'Cochrane Metabolic and Endocrine Disorders Group, Institute of General Practice, Medical Faculty of the Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013516.pub2']
1600,33207014,Efficacy of vitamin D supplementation in asthmatic children with vitamin D deficiency: A randomized controlled trial (ESDAC trial).,"BACKGROUND
Vitamin D supplementations for asthma control had shown inconsistent results. We aimed to study efficacy and safety of vitamin D supplementation in asthmatic children who were vitamin D deficient.
METHODS
This double-blind, randomized controlled trial enrolled asthmatic children of 4-12 years of age who had 25-hydroxyvitamin D [25(OH)D] levels <20 ng/mL. The participants were randomized to receive either vitamin D orally 1000 IU/d for 9 months or similar-looking placebo. The primary outcomes were the proportion of children having the Childhood Asthma Control Test (CACT) score of ≥20 at the end of the treatment and adverse effects.
RESULTS
The trial included 250 children (125 in each group) with a mean age of 8.1 ± 2.3 years and 180 boys. The baseline parameters were similar between the groups, including CACT score (21.7 ± 4.2 vs 21.9 ± 3.6, vitamin D vs placebo). At the end of the study, the proportion of asthmatic children who had CACT score ≥ 20 was similar between vitamin D and placebo group (93.6% vs 92.0%, P = .625). The number of exacerbations of asthma and side effect profile was also identical between the groups. 25(OH)D levels increased significantly in the vitamin D group (18.06 ± 7.11 vs 12.03 ± 5.98 ng/mL, P < .001). The results did not change when we did subgroup analysis for children with baseline CACT score < 20 and 25(OH)D levels at the end of the study ≥20 ng/mL.
CONCLUSION
Vitamin D supplementation in asthmatic children with vitamin D deficiency did not improve control of asthma.",2020,"25(OH)D levels increased significantly in the vitamin D group (18.06±7.11 vs 12.03±5.98 ng/ml, p<0.001).","['enrolled asthmatic children of 4-12 years of age who had 25-hydroxyvitamin D [25(OH)D] levels < 20 ng/ml', 'asthmatic children with vitamin D deficiency', 'asthmatic children who were vitamin D deficient', '250 children (125 in each group) with a mean age of 8.1±2.3 years and 180 boys']","['vitamin D supplementation', 'vitamin D', 'vitamin D and placebo', 'Vitamin D supplementation', 'vitamin D orally 1000 IU/day for nine months or similar-looking placebo']","['CACT score', 'proportion of children having the Childhood Asthma Control Test (CACT) score of ≥ 20 at the end of the treatment and adverse effects', '25(OH)D levels', 'control of asthma', 'number of exacerbations of asthma and side effect profile']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0870221', 'cui_str': 'Male child'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C1272570', 'cui_str': 'Test control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}]",250.0,0.719372,"25(OH)D levels increased significantly in the vitamin D group (18.06±7.11 vs 12.03±5.98 ng/ml, p<0.001).","[{'ForeName': 'Kana Ram', 'Initials': 'KR', 'LastName': 'Jat', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Department of Endocrinology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Chandra Prakash', 'Initials': 'CP', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sudip', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Department of Laboratory Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Lodha', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sushil K', 'Initials': 'SK', 'LastName': 'Kabra', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13415']
1601,33207580,Feasibility of a Tai Chi with Thera-Band Training Program: A Pilot Study.,"Tai Chi, combined with Thera-band (TCTB) exercise may be associated with an improvement in health where it increases physical fitness, improves psychological well-being, and decreases pain. This paper aimed to determine the feasibility of TCTB exercise in older sedentary office workers. Forty office workers aged over 55 years participated in a pilot randomized controlled trial (i.e., 12-week TCTB exercise or Tai Chi exercise only). Feasibility of the TCTB exercise approach was ascertained through the recruitment and enrolment rate, acceptability of the study intervention by participants including retention and adherence rates, participants' learning process, the appropriateness of data collection as well as the participants' evaluation of the intervention. Recruitment took longer than planned, with a low recruitment rate of 2.0% (42/2020), but a high enrolment rate of 95.2% (40/42). Thirty-one participants (i.e., 77.5%) completed the intervention. Of those who completed the trial, the overall average attendance was reported as 85.2%; 84.7% in the TCTB group and 85.7% in the Tai Chi only group. A total of 58.3% of participants ( n = 21) could independently practice the TCTB or Tai Chi exercise motions at the end of the learning stage. There were no missing data except for the nine participants who withdrew during the intervention. No adverse events or effects were reported, and all participants were satisfied with the 12-week exercise intervention. Results support the feasibility of a large-scale randomized controlled trial to explore the efficacy of a TCTB program for improving health in older sedentary office workers.",2020,A total of 58.3% of participants ( n = 21) could independently practice the TCTB or Tai Chi exercise motions at the end of the learning stage.,"['older sedentary office workers', 'Forty office workers aged over 55 years']","['TCTB exercise or Tai Chi exercise only', 'Tai Chi with Thera-Band Training Program', 'TCTB program', 'TCTB exercise approach', 'TCTB exercise', 'Tai Chi, combined with Thera-band (TCTB) exercise', 'TCTB']","['TCTB or Tai Chi exercise motions', 'overall average attendance']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0874433,A total of 58.3% of participants ( n = 21) could independently practice the TCTB or Tai Chi exercise motions at the end of the learning stage.,"[{'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'School of Nursing, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Moyle', 'Affiliation': 'Nathan Campus, Menzies Health Institute Queensland, Griffith University, Brisbane, QLD 4111, Australia.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Nathan Campus, Menzies Health Institute Queensland, Griffith University, Brisbane, QLD 4111, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Weeks', 'Affiliation': 'Nathan Campus, Menzies Health Institute Queensland, Griffith University, Brisbane, QLD 4111, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17228462']
1602,33207606,Effects of Beetroot Powder with or without L-Arginine on Postprandial Vascular Endothelial Function: Results of a Randomized Controlled Trial with Abdominally Obese Men.,"BACKGROUND
Through effects on nitric oxide bioavailability, vascular endothelial function is improved after the intake of a high amount of nitrate or L-arginine, but decreased after the intake of a high-fat meal. Therefore, we compared the effects of beetroot powder with or without L-arginine on postprandial brachial artery flow-mediated vasodilation (FMD) after consumption of a high-fat mixed-meal.
METHODS
Eighteen abdominally obese men completed this randomized, double-blinded, cross-over trial. The study consisted of five test days, each separated by a wash-out period of at least one week. Participants received in random order, a blended meal with a control or nutritional supplement consisting of beetroot powder providing 200 mg nitrate, beetroot with 0.8 g of L-arginine, beetroot with 1.5 g of L-arginine, or 3.0 g of L-arginine. Participants then fasted and 2 h postprandial FMD measurements were performed.
RESULTS
No significant differences between meals were observed for postprandial FMD ( p = 0.45) levels. However, there was a non-significant trend towards a more beneficial postprandial FMD response with the beetroot-containing meals as compared with meals without beetroot.
CONCLUSION
This trial could not provide evidence for beneficial additive effects of a single dose of beetroot powder combined with L-arginine on postprandial endothelial function in abdominally obese men.",2020,No significant differences between meals were observed for postprandial FMD ( p = 0.45) levels.,"['Eighteen abdominally obese men', 'abdominally obese men', 'Abdominally Obese Men']","['Beetroot Powder with or without L-Arginine', 'beetroot powder combined with L-arginine', 'blended meal with a control or nutritional supplement consisting of beetroot powder providing 200 mg nitrate, beetroot with 0.8 g of L-arginine, beetroot with 1.5 g of L-arginine, or 3.0 g of L-arginine', 'beetroot powder with or without L-arginine']","['Postprandial Vascular Endothelial Function', 'beneficial postprandial FMD response', 'postprandial endothelial function', 'postprandial FMD', 'postprandial brachial artery flow-mediated vasodilation (FMD', 'nitric oxide bioavailability, vascular endothelial function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.307233,No significant differences between meals were observed for postprandial FMD ( p = 0.45) levels.,"[{'ForeName': 'Ellen T H C', 'Initials': 'ETHC', 'LastName': 'Smeets', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Hoeks', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'de Vogel-Van den Bosch', 'Affiliation': 'Danone Nutricia Research, 3584 Utrecht, The Netherlands.'}, {'ForeName': 'Robert J J', 'Initials': 'RJJ', 'LastName': 'Hageman', 'Affiliation': 'Danone Nutricia Research, 3584 Utrecht, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Center, P.O. Box 616, 6200 Maastricht, The Netherlands.'}]",Nutrients,['10.3390/nu12113520']
1603,33207656,Comparative Analysis of Root Canal Filling Debris and Smear Layer Removal Efficacy Using Various Root Canal Activation Systems during Endodontic Retreatment.,"The complete removal of obturation material can be a challenge in nonsurgical root canal retreatment. The insufficient removal of obturation material is a reason for root canal retreatment failure. The purpose of this study was to assess the efficacy of different final root canal irrigation activation methods in removing debris and smear layers in the apical and middle portions of root canals during retreatment. Sixty-six distal roots of freshly extracted molars were randomly divided into six groups: (1) primary root canal treatment with no obturation (negative control); (2) retreatment with only conventional instrumentation and irrigation (positive control); (3) retreatment with additional ultrasonic irrigation using the Piezon Master 700; (4) ultrasonic irrigation with the ENDOSONIC Blue; (5) sonic irrigation with the EDDY; and (6) multisonic irrigation with the GentleWave system. Roots were split and prepared for scanning electron microscopic (SEM) evaluation. Acquired images were assessed to quantify the amount of debris and smear remaining. Among the treatment groups, Group 6 had a significantly lower debris score than Group 2 (positive control) in both the middle and apical regions ( p = 0.004, p = 0.012). All treatment groups showed significantly lower smear scores than Group 2 in the middle and apical regions ( p < 0.05). The GentleWave multisonic System showed a more optimal cleaning efficacy of the root canal debris but did not differ significantly with the tested passive ultrasonic or sonic irrigation method.",2020,The GentleWave multisonic System showed a more optimal cleaning efficacy of the root canal debris but did not differ significantly with the tested passive ultrasonic or sonic irrigation method.,['Sixty-six distal roots of freshly extracted molars'],"['primary root canal treatment with no obturation (negative control); (2) retreatment with only conventional instrumentation and irrigation (positive control); (3) retreatment with additional ultrasonic irrigation using the Piezon Master 700; (4) ultrasonic irrigation with the ENDOSONIC Blue; (5) sonic irrigation with the EDDY; and (6) multisonic irrigation with the GentleWave system', 'Root Canal Filling Debris and Smear Layer Removal Efficacy Using Various Root Canal Activation Systems']","['debris score', 'smear scores']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0447373', 'cui_str': 'Distal tooth root'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]","[{'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}]",,0.0198792,The GentleWave multisonic System showed a more optimal cleaning efficacy of the root canal debris but did not differ significantly with the tested passive ultrasonic or sonic irrigation method.,"[{'ForeName': 'Seong Yeon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, College of Dentistry, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Mo Kwan', 'Initials': 'MK', 'LastName': 'Kang', 'Affiliation': 'Department of Endodontics, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Hae Won', 'Initials': 'HW', 'LastName': 'Choi', 'Affiliation': 'Department of Dental Biomaterials Science, School of Dentistry, Seoul National University, Seoul 08826, Korea.'}, {'ForeName': 'Won-Jun', 'Initials': 'WJ', 'LastName': 'Shon', 'Affiliation': 'Department of Conservative Dentistry, College of Dentistry, Seoul National University, Seoul 08826, Korea.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56110615']
1604,33207670,Effects of Virtual Reality on Cardiac Rehabilitation Programs for Ischemic Heart Disease: A Randomized Pilot Clinical Trial.,"(1) Background: The aim of the present study was to determine the effects of a virtual reality (VR) program, as a complementary tool to a conventional cardiac rehabilitation (CR) program in phase II of patients with ischemic heart disease compared to a conventional treatment group. (2) Methods: A single blinded randomized clinical trial was conducted. The patients were randomized to a control group (CG) or an experimental group (EG). The EG carried out a training based on VR of aerobic exercise using the XBOX ONE console and Kinect sensor. Ergometry, metabolic equivalents (METS), Functional Independence Measure, 6-min walk test (6MWT), the Short Form Health Survey-36 Questionnaire (SF-36), the Beck Depression Inventory-II, and the degree of satisfaction and adherence to treatment were used as outcome measures. (3) Results: Our results showed no statistically significant differences between the two groups. Statistical analysis within group for the EG showed statistically significant changes in the variables HR final ergometry, ergometry minutes, % ergometry, METS, final HR 6MWT, 6MWT distance, 6MWT number of laps, and for the SF-36 and Beck Depression Inventory-II. (4) Conclusion: A VR-based video game program, as an adjunct tool to a CR program, showed improvements in ergometry, METS, resistance to fatigue and health-related quality of life with excellent adherence and satisfaction perceived by patients with ischemic heart disease in phase II.",2020,Our results showed no statistically significant differences between the two groups.,"['patients with ischemic heart disease in phase II', 'Ischemic Heart Disease', 'patients with ischemic heart disease compared to a conventional treatment group']","['VR-based video game program', 'Virtual Reality', 'control group (CG', 'conventional cardiac rehabilitation (CR) program', 'virtual reality (VR) program']","['variables HR final ergometry, ergometry minutes, % ergometry, METS, final HR 6MWT, 6MWT distance, 6MWT number of laps, and for the SF-36 and Beck Depression Inventory-II', 'ergometry, METS, resistance to fatigue and health-related quality of life with excellent adherence and satisfaction', 'Ergometry, metabolic equivalents (METS), Functional Independence Measure, 6-min walk test (6MWT), the Short Form Health Survey-36 Questionnaire (SF-36), the Beck Depression Inventory-II, and the degree of satisfaction and adherence to treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0376413,Our results showed no statistically significant differences between the two groups.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'García-Bravo', 'Affiliation': 'International Doctorate School, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Cano-de-la-Cuerda', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Domínguez-Paniagua', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Campuzano-Ruiz', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Barreñada-Copete', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'María Jesús', 'Initials': 'MJ', 'LastName': 'López-Navas', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Araujo-Narváez', 'Affiliation': 'Cardiac Rehabilitation Unit, Hospital Universitario Fundación Alcorcón, Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'García-Bravo', 'Affiliation': 'International Doctorate School, Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Florez-Garcia', 'Affiliation': 'Rehabilitation Service, Hospital Universitario Fundación Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Botas-Rodríguez', 'Affiliation': 'Cardiology Service, Hospital Universitario Fundación Alcorcón, 28922 Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Cuesta-Gómez', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Faculty of Health Sciences, Rey Juan Carlos University, 28922 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228472']
1605,33207693,"How Volatile Compounds, Oxidative Profile and Sensory Evaluation Can Change with Vacuum Aging in Donkey Meat.","This study aims to improve knowledge on donkey meat and the vacuum aging effect on the Volatile Organic Compounds (VOCs), oxidative profile and status and the sensory characteristics. Ten 18-month old Martina Franca donkeys' male foals were involved in the trial. Longissimus thoracis (LT) muscle was extracted from each left half carcass, between the fourth and the ninth rib. Each muscle was divided into five sections, vacuum packaged, stored at 2 °C, and randomly assigned to one of the different aging time (1, 3, 6, 9, and 14 days of aging). Volatile compounds, oxidation parameters, and antioxidant enzymes were analysed, and a sensory test was performed. A nested one-way analysis of variance (ANOVA) was performed for aging time as an independent variable. Significance was set at p < 0.05. Aldehydes are the most produced VOCs, but no changes were observed during vacuum aging ( p > 0.05). Nitrogen compounds increased during aging ( p < 0.01). TBARs and hydroperoxides did not change during the storage, whereas the protein carbonyls increased ( p < 0.05). Vacuum aging slowed down lipid oxidation and put in evidence the presence of protein oxidation and degradation, influencing the VOCs productions and sensory evaluation.",2020,"Aldehydes are the most produced VOCs, but no changes were observed during vacuum aging ( p > 0.05).","[""Ten 18-month old Martina Franca donkeys' male foals were involved in the trial""]",[],"['Volatile compounds, oxidation parameters, and antioxidant enzymes', 'protein carbonyls', 'Volatile Organic Compounds (VOCs), oxidative profile and status and the sensory characteristics', 'TBARs and hydroperoxides']","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0324145', 'cui_str': 'Equus asinus'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}]",,0.0287915,"Aldehydes are the most produced VOCs, but no changes were observed during vacuum aging ( p > 0.05).","[{'ForeName': 'Aristide', 'Initials': 'A', 'LastName': 'Maggiolino', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Lorenzo', 'Affiliation': 'Centro Tecnológico de la Carne de Galicia, Parque Tecnológico de Galicia, 32900 Ourense, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Centoducati', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Domínguez', 'Affiliation': 'Centro Tecnológico de la Carne de Galicia, Parque Tecnológico de Galicia, 32900 Ourense, Spain.'}, {'ForeName': 'Francesca Rita', 'Initials': 'FR', 'LastName': 'Dinardo', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Marino', 'Affiliation': 'Department of Agricultural Food and Environmental Sciences, University of Foggia, 71121 Foggia, Italy.'}, {'ForeName': 'Antonella Della', 'Initials': 'AD', 'LastName': 'Malva', 'Affiliation': 'Department of Agricultural Food and Environmental Sciences, University of Foggia, 71121 Foggia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bragaglio', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'De Palo', 'Affiliation': 'Department of Veterinary Medicine, University of Bari A. Moro, 70010 Valenzano, Bari, Italy.'}]",Animals : an open access journal from MDPI,['10.3390/ani10112126']
1606,33207743,"Administration of an Intravenous Fat Emulsion Enriched with Medium-Chain Triglyceride/ω-3 Fatty Acids is Beneficial Towards Anti-Inflammatory Related Fatty Acid Profile in Preterm Neonates: A Randomized, Double-Blind Clinical Trial.","Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. We aimed to investigate the effects of a medium-chain triglyceride (MCT)/ω-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile and serum interleukin-6 (IL-6) in preterm neonates. In this double-blind randomized study, 92 preterm neonates (gestational age < 32 weeks, birth weight < 1500 g) were assigned to receive either MCT/ω-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry. Serum IL-6 was measured with sandwich ELISA in 59 neonates. Plasma FAs changed significantly over time; the MCT/ω-3 PUFA-IVFE group showed higher ω-3 PUFAs ( p = 0.031), eicosapentaenoic acid ( p = 0.000), and oleic acid ( p = 0.003), and lower ω-6/ω-3 PUFAs ratio ( p = 0.001) and ω-6 PUFAs ( p = 0.023) compared to control group. Linoleic acid was higher in the soybean oil (SO)-based IVFE arm compared to the MCT/ω-3 PUFAs-IVFE arm ( p = 0.006). Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups. Administration of MCT/ω-3 PUFA-enriched IVFE in preterm neonates is beneficial in changing the FA profile consistent with attenuated inflammatory response.",2020,"Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups.","['preterm neonates', 'Preterm Neonates', '92 preterm neonates (gestational age < 32 weeks, birth weight < 1500 g', '59 neonates']","['pure soybean oil emulsions', 'MCT/ω-3 PUFA-enriched IVFE', 'MCT/ω-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group', 'soybean oil (SO)-based IVFE', 'medium-chain triglyceride (MCT)/ω-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE', 'MCT/ω-3 PUFA-IVFE', 'Intravenous Fat Emulsion Enriched with Medium-Chain Triglyceride/ω-3 Fatty Acids']","['Linoleic acid', 'ω-3 PUFAs', 'Levels of FAs', 'eicosapentaenoic acid', 'IL-6', 'Plasma FAs', 'lower ω-6/ω-3 PUFAs ratio', 'plasma fatty acid (FA) profile and serum interleukin-6 (IL-6', 'Serum IL-6', 'oleic acid', 'ω-6 PUFAs']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0015667', 'cui_str': 'Lipid Emulsions, Intravenous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}]","[{'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}]",92.0,0.664658,"Both fat emulsion types decreased IL-6 compared to baseline, but changes were insignificant between groups.","[{'ForeName': 'Panos', 'Initials': 'P', 'LastName': 'Papandreou', 'Affiliation': 'First Department of Pediatrics, Medical School, National & Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Goudi, 11527 Athens, Greece.'}, {'ForeName': 'Aristea', 'Initials': 'A', 'LastName': 'Gioxari', 'Affiliation': 'Department of Nutritional Science and Dietetics, Harokopio University, Kallithea, 17671 Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Ntountaniotis', 'Affiliation': 'Department of Chemistry, National and Kapodistrian University of Athens, Zografou, 15771 Athens, Greece.'}, {'ForeName': 'Olga-Natalia', 'Initials': 'ON', 'LastName': 'Korda', 'Affiliation': 'Department of Nutritional Science and Dietetics, Harokopio University, Kallithea, 17671 Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Skouroliakou', 'Affiliation': 'Department of Nutritional Science and Dietetics, Harokopio University, Kallithea, 17671 Athens, Greece.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Siahanidou', 'Affiliation': 'First Department of Pediatrics, Medical School, National & Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Goudi, 11527 Athens, Greece.'}]",Nutrients,['10.3390/nu12113526']
1607,33208019,Twenty-Four-Hour Cardiovascular Effects of Electronic Cigarettes Compared With Cigarette Smoking in Dual Users.,"Background Cardiovascular safety is an important consideration regarding the benefits versus risks of electronic cigarette use (EC) for public health. The single-use cardiovascular effects of EC have been well studied but may not reflect effects of ad libitum use throughout the day. We aimed to compare the circadian hemodynamic effects as well as 24-hour biomarkers of oxidative stress, and platelet aggregation and inflammation, with ad libitum cigarette smoking (CS) versus EC versus no tobacco product use. Methods and Results Thirty-six healthy dual CS and EC users participated in a crossover study in a confined research setting. Circadian heart rate, blood pressure and plasma nicotine levels, 24-hour urinary catecholamines, 8-isoprostane and 11-dehydro-thromboxane B2, and plasma interleukin-6 and interleukin-8 were compared in CS, EC, and no nicotine conditions. Over 24 hours, and during daytime, heart rate and blood pressure were higher in CS and EC compared with no tobacco product conditions ( P <0.01). Heart rate on average was higher with CS versus EC. Urinary catecholamines, 8-isoprostane, and 11-dehydro-thromboxane B2 were not significantly different, but plasma IL-6 and IL-8 were higher with both CS and EC compared with no tobacco product ( P <0.01). Conclusions CS and EC had similar 24-hour patterns of hemodynamic effects compared with no tobacco product, with a higher average heart rate with CS versus EC, and similar effects on biomarkers of inflammation. EC may pose some cardiovascular risk, particularly to smokers with underlying cardiovascular disease, but may also provide a harm reduction opportunity for smokers willing to switch entirely to EC. Registration URL: https://www.clinicaltrials.gov; Unique Identifier: NCT02470754.",2020,"Over 24 hours, and during daytime, heart rate and blood pressure were higher in CS and EC compared with no tobacco product conditions ( P <0.01).","['smokers with underlying cardiovascular disease', 'Thirty-six healthy dual CS and EC users participated in a crossover study in a confined research setting']","['Electronic Cigarettes', 'ad libitum cigarette smoking (CS) versus EC', 'EC']","['circadian hemodynamic effects', 'plasma IL-6 and IL-8', 'daytime, heart rate and blood pressure', 'hemodynamic effects', 'Circadian heart rate, blood pressure and plasma nicotine levels, 24-hour urinary catecholamines, 8-isoprostane and 11-dehydro-thromboxane B2, and plasma interleukin-6 and interleukin-8', 'Heart rate', 'Urinary catecholamines, 8-isoprostane, and 11-dehydro-thromboxane B2']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C4280017', 'cui_str': 'Electronic Cigarette Use'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C4280017', 'cui_str': 'Electronic Cigarette Use'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0044728', 'cui_str': '11-dehydro-thromboxane B2'}]",36.0,0.0831907,"Over 24 hours, and during daytime, heart rate and blood pressure were higher in CS and EC compared with no tobacco product conditions ( P <0.01).","[{'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'St Helen', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Newton', 'Initials': 'N', 'LastName': 'Addo', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Junfeng Jim', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'Global Health Institute & Nicholas School of the Environment Duke University Durham NC.'}, {'ForeName': 'Arit M', 'Initials': 'AM', 'LastName': 'Harvanko', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Calfee', 'Affiliation': 'Division of Pulmonary Critical Care Allergy and Sleep Medicine Department of Medicine University of California San Francisco CA.'}, {'ForeName': 'Peyton', 'Initials': 'P', 'LastName': 'Jacob', 'Affiliation': 'Clinical Pharmacology Research Program Division of Cardiology Department of Medicine University of California San Francisco CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017317']
1608,33208303,Development in PaCO 2 over 12 months in patients with COPD with persistent hypercapnic respiratory failure treated with high-flow nasal cannula-post-hoc analysis from a randomised controlled trial.,"INTRODUCTION
Persistent hypercapnic failure in chronic obstructive pulmonary disease (COPD) is associated with poor prognosis. Long-term home non-invasive ventilation is recommended for patients with PaCO 2 >7.0 kPa. Domiciliary high-flow nasal cannula (HFNC) reduces PaCO 2 in short-term studies. This post-hoc analysis examines the effect of HFNC on PaCO 2 levels, exacerbations and admissions in patients with COPD with persistent hypercapnic and hypoxic failures.
METHODS
The original trial included 74 long-term oxygen-treated patients (31 HFNC treated/43 controls) with persistent hypercapnic failure (PaCO 2 >6 kPa) who completed the 12-month study period. Baseline data included age, sex, blood gases, exacerbations and hospital admissions in the previous year. Data on blood gases were also recorded at 6 and 12 months for all patients. In addition, acute changes in blood gases after 30 min of HFNC use at site visits were examined, as were exacerbations and hospital admissions during study.
RESULTS
Patients were comparable at baseline. After 12 months there was a 1.3% decrease in PaCO 2 in patients using HFNC and a 7% increase in controls before HFNC use on site (p=0.003). After 30 min of HFNC at visits PaCO 2 changed significantly, with comparable reductions, at 0, 6 and 12 months, including for controls who tried HFNC at study end (p<0.001). The exacerbation rate increased, compared with 12 months prestudy, by 2.2/year for controls (p<0.001) and 0.15/year for HFNC-treated patients (p=0.661). Hospital admission rates increased in the control group,+0.3/year from prestudy (p=0.180), And decreased by 0.67/year (p=0.013)for HFNC-treated patients.
CONCLUSION
This post-hoc analysis indicates that HFNC stabilises patients with COPD with persistent hypoxic and hypercapnic failures, in terms of PaCO 2 , exacerbations and number of hospitalisations, whereas those not receiving HFNC worsened. This suggests that HFNC is a possible treatment for patients with persistent hypercapnic COPD.",2020,"Hospital admission rates increased in the control group,+0.3/year from prestudy (p=0.180), And decreased by 0.67/year (p=0.013)for HFNC-treated patients.
","['74 long-term oxygen-treated patients (31 HFNC treated/43 controls) with persistent hypercapnic failure (PaCO 2 >6\u2009kPa) who completed the 12-month study period', 'patients with persistent hypercapnic COPD', 'patients with PaCO 2 >7.0\u2009kPa', 'chronic obstructive pulmonary disease (COPD', 'patients with COPD with persistent hypercapnic respiratory failure', 'patients with COPD with persistent hypercapnic and hypoxic failures']","['HFNC', 'Domiciliary high-flow nasal cannula (HFNC']","['Hospital admission rates', 'blood gases', 'exacerbation rate', 'PaCO']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0338047', 'cui_str': 'Domiciliary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}]",74.0,0.183511,"Hospital admission rates increased in the control group,+0.3/year from prestudy (p=0.180), And decreased by 0.67/year (p=0.013)for HFNC-treated patients.
","[{'ForeName': 'Line Hust', 'Initials': 'LH', 'LastName': 'Storgaard', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, North Denmark Region, Denmark.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Hockey', 'Affiliation': 'Biometric Matters Limited, Hamilton, New Zealand.'}, {'ForeName': 'Ulla Møller', 'Initials': 'UM', 'LastName': 'Weinreich', 'Affiliation': 'Department of Respiratory Diseases, Aalborg University Hospital, Aalborg, North Denmark Region, Denmark ulw@rn.dk.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000712']
1609,33208325,"Biofortification of wheat with zinc for eliminating deficiency in Pakistan: study protocol for a cluster-randomised, double-blind, controlled effectiveness study (BIZIFED2).","INTRODUCTION
Micronutrient deficiencies, commonly referred to as 'hidden hunger', affect more than two billion people worldwide, with zinc and iron-deficiency frequently reported. The aim of this study is to examine the impact of consuming zinc biofortified flour (Zincol-2016) on biochemical and functional measures of status in adolescent girls and children living in a low-resource setting in Pakistan.
METHODS AND ANALYSIS
We are conducting a pragmatic, cluster-randomised, double-blind, controlled trial. A total of 482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar. Household inclusion criteria are the presence of both an adolescent girl, aged 10-16 years, and a child aged 1-5 years. The study duration is 12 months, divided into two 6-month phases. During phase 1, all households will be provided with locally procured flour from standard varieties of wheat. During phase 2, clusters will be paired, and randomised to either the control or intervention arm of the study. The intervention arm will be provided with zinc biofortified wheat flour, with a target zinc concentration of 40 mg/kg. The control arm will be provided with locally procured wheat flour from standard varieties with an expected zinc concentration of 20 mg/kg. The primary outcome measure is plasma zinc concentration. Secondary outcomes include anthropometric measurements, biomarkers of iron and zinc status, and the presence and duration of respiratory tract infections and diarrhoea.
ETHICS AND DISSEMINATION
Ethical approval was granted from the University of Central Lancashire STEMH Ethics Committee (reference number: STEMH 1014) and Khyber Medical University Ethics Committee (DIR/KMU-EB/BZ/000683). The final study methods will be published in peer-reviewed journals, alongside the study outcomes. In addition, findings will be disseminated to the scientific community via conference presentations and abstracts and communicated to the study participants through the village elders at an appropriate community forum.
TRIAL REGISTRATION NUMBER
ISRCTN17107812; Pre-results.",2020,A total of 482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar.,"['adolescent girls and children living in a low-resource setting in Pakistan', '482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar', 'participants through the village elders at an appropriate community forum', 'Household inclusion criteria are the presence of both an adolescent girl, aged 10-16 years, and a child aged 1-5 years']","['wheat with zinc', 'consuming zinc biofortified flour (Zincol-2016']","['anthropometric measurements, biomarkers of iron and zinc status, and the presence and duration of respiratory tract infections and diarrhoea', 'plasma zinc concentration']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016260', 'cui_str': 'Flour'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",482.0,0.535024,A total of 482 households have been recruited from two catchment areas approximately 30-40 km distance from Peshawar.,"[{'ForeName': 'Nicola M', 'Initials': 'NM', 'LastName': 'Lowe', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK NMLowe@uclan.ac.uk.'}, {'ForeName': 'Mukhtiar', 'Initials': 'M', 'LastName': 'Zaman', 'Affiliation': 'Department of Pulmonology, Rehman Medical Institute, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Victoria Hall', 'Initials': 'VH', 'LastName': 'Moran', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ohly', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sinclair', 'Affiliation': 'UCLan Research Centre for Global Development, University of Central Lancashire, Preston, UK.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Fatima', 'Affiliation': 'Institute of Basic Medical sciences, Khyber Medical University, Peshawar, Pakistan.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Broadley', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Edward J M', 'Initials': 'EJM', 'LastName': 'Joy', 'Affiliation': 'Department of Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Mahboob', 'Affiliation': 'Institute of Health Professions Education and Research, Khyber Medical University, Peshawar, Pakistan.'}, {'ForeName': 'R Murray', 'Initials': 'RM', 'LastName': 'Lark', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Munir H', 'Initials': 'MH', 'LastName': 'Zia', 'Affiliation': 'Research and Development, Fauji Fertilizer Co Ltd, Rawalpindi, Punjab, Pakistan.'}, {'ForeName': 'E Louise', 'Initials': 'EL', 'LastName': 'Ander', 'Affiliation': 'Inorganic Chemistry, Centre for Environmental Geochemistry, British Geological Survey, Nottingham, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Sharp', 'Affiliation': 'Nutritional Sciences, Kings College London, London, UK.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Bailey', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Young', 'Affiliation': 'School of Biosciences, University of Nottingham, Sutton Bonington Campus, Nottingham, UK.'}, {'ForeName': 'Muhammad Jaffar', 'Initials': 'MJ', 'LastName': 'Khan', 'Affiliation': 'Institute of Basic Medical sciences, Khyber Medical University, Peshawar, Pakistan.'}]",BMJ open,['10.1136/bmjopen-2020-039231']
1610,33211921,[The effect of administration of dietary supplement with calcium and vitamins D 3 and B 6 on calcium homeostasis and falls incidence in patients with high fracture risk undergoing medical rehabilitation].,"Elimination of vitamin D and calcium deficiencies is of particular importance in older patients undergoing medical rehabilitation after a serious illness, surgery or injury and having a high risk of fractures. Preventing falls and fractures, including during the course of rehabilitation, is an important challenge that can be addressed in these patients, in particular through improved nutrition and vitamin D and calcium supplementation. The aim of the study was to evaluate the effect of long-term intake of a complex dietary supplement with calcium and vitamins D 3 and B 6 on calcium homeostasis and the frequency of falls in patients with high fracture risk undergoing medical rehabilitation. Material and methods . The study enrolled 109 women and 10 men (mean age 65.5±7.9 years) with high fracture risk who were undergoing medical rehabilitation. After baseline examination, 41 patients have been receiving antiresorptive therapy already comprised group 1, and patients who didn't receive osteoporotic therapy were randomized into groups 2 (n=39) and 3 (control, n=39). Patients in groups 1 and 2 for 12 months were prescribed a dietary supplement containing calcium in a daily dose of 200 mg (in the form of citrate 1000 mg), 600 IU of vitamin D 3 and 2 mg of vitamin B 6 . All patients underwent assessment of bone mineral density (BMD), calculation of absolute 10-year fracture risk according to FRAX, assessment of food calcium intake, etermination of biochemical parameters of calcium-phosphorus metabolism and bone remodeling (total calcium, inorganic phosphorus, alkaline phosphatase activity - by colorimetric method in blood serum; immunoreactive parathyroid hormone (PTH) and osteocalcin - by electrochemiluminescence immunoassay in blood serum; β-isomer of C-terminal telopeptide of type I collagen (CTx) and 25(OH)D in blood plasma - by immunochemiluminescence analysis), cases of falls and fractures were fixed. Results . Average daily intake of calcium in the studied sample (n=119) was 782.9±243.4 mg, and 67.2% of patients consumed less than 800 mg of calcium daily. Vitamin D deficit was detected in 38.4% of the examined, its insufficiency - in 32.8%. An increase in 25(OH)D concentration was noted in groups 1 and 2 after 6 and 12 months (p<0.01), while in group 3 there was no dynamics of 25(OH)D (p>0.05). Patients in group 1 showed an increase in the level of osteocalcin and total calcium after 6 and 12 months, as well as alkaline phosphatase activity after 6 months (p<0.05). In group 3, there was an increase of PTH levels after 6 (p<0.05) and 12 months (p<0.01), CTx and alkaline phosphatase activity after 12 months (p<0.05). In group 1, there was an increase in BMD in the spine (+4.2%, p=0.024), femoral neck (+3.0%, p=0.041), and total femur (+2.7%, p=0.045), in patients of group 2 - an increase in BMD in the spine (+1.8%, p=0.048). In group 1, there was also a decrease in proportion of patients who fell after 6 months (χ 2 =4.97, p=0.026) and a decrease in the total number of falls after 12 months (χ 2 =4.89, p=0.027). Group 2 showed a decrease in the number of patients who fell after 6 and 12 months (χ 2 =48.58, p=0.0034 at both stages of the study) and the number of falls in general after 6 months (χ 2 =6.02, p=0.0142). Conclusion . The obtained data allow us to recommend prescription of dietary supplements containing calcium and vitamin D 3 as a part of complex rehabilitation of patients with high fracture risk.",2020,"In group 3, there was an increase of PTH levels after 6 (p<0.05) and 12 months (p<0.01), CTx and alkaline phosphatase activity after 12 months (p<0.05).","['patients with high fracture risk undergoing medical rehabilitation', ""41 patients have been receiving antiresorptive therapy already comprised group 1, and patients who didn't receive osteoporotic therapy"", 'patients with high fracture risk', 'older patients undergoing medical rehabilitation after a serious illness, surgery or injury and having a high risk of fractures', '109 women and 10 men (mean age 65.5±7.9 years) with high fracture risk who were undergoing medical rehabilitation']","['vitamin D and calcium deficiencies', 'complex dietary supplement with calcium and vitamins D 3 and B 6', 'dietary supplement containing calcium', 'vitamin D 3 and 2 mg of vitamin B 6 ', 'dietary supplement with calcium and vitamins D 3 and B 6']","['bone mineral density (BMD), calculation of absolute 10-year fracture risk according to FRAX, assessment of food calcium intake, etermination of biochemical parameters of calcium-phosphorus metabolism and bone remodeling (total calcium, inorganic phosphorus, alkaline phosphatase activity - by colorimetric method in blood serum; immunoreactive parathyroid hormone (PTH) and osteocalcin - by electrochemiluminescence immunoassay in blood serum; β-isomer of C-terminal telopeptide of type I collagen (CTx) and 25(OH)D in blood plasma - by immunochemiluminescence analysis), cases of falls and fractures', '25(OH)D concentration', 'Average daily intake of calcium', 'alkaline phosphatase activity', 'BMD', 'total femur', 'CTx and alkaline phosphatase activity', 'femoral neck', 'calcium homeostasis and falls incidence', 'level of osteocalcin and total calcium', 'total number of falls', 'Vitamin D deficit', 'number of falls', 'PTH levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0392519', 'cui_str': 'Calcium deficiency'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0020980', 'cui_str': 'Immunoassay method'}, {'cui': 'C0022203', 'cui_str': 'Isomerism'}, {'cui': 'C1101784', 'cui_str': 'ICTP peptide'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3653518', 'cui_str': 'CALCIUM HOMEOSTASIS'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",109.0,0.0433026,"In group 3, there was an increase of PTH levels after 6 (p<0.05) and 12 months (p<0.01), CTx and alkaline phosphatase activity after 12 months (p<0.05).","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Marchenkova', 'Affiliation': 'National Medical Research Center of Rehabilitation and Balneology of Ministry of Health of Russian Federation, 121099, Moscow, Russian Federation.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Fesyun', 'Affiliation': 'National Medical Research Center of Rehabilitation and Balneology of Ministry of Health of Russian Federation, 121099, Moscow, Russian Federation.'}, {'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Gerasimenko', 'Affiliation': 'Russian Medical Academy of Continuing Professional Education, 125993, Moscow, Russian Federation.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Makarova', 'Affiliation': 'National Medical Research Center of Rehabilitation and Balneology of Ministry of Health of Russian Federation, 121099, Moscow, Russian Federation.'}]",Voprosy pitaniia,['10.24411/0042-8833-2020-10069']
1611,33212907,PROFAST: A Randomized Trial Assessing the Effects of Intermittent Fasting and Lacticaseibacillus rhamnosus Probiotic among People with Prediabetes.,"Both intermittent fasting and specific probiotics have shown promise in improving glucose tolerance with a potential for synergistic effects through alterations to gut microbiota. In this randomized, double-blinded, two-arm feasibility study, we investigated whether intermittent fasting, supplemented with Lacticaseibacillus rhamnosus HN001 probiotic, reduces HbA1c in individuals with prediabetes. All participants with HbA1c 40-50 mmol/mol commenced intermittent fasting (2 days per week of calorie restriction to 600-650 kcal/day) and were randomized 1:1 to either daily probiotic ( Lacticaseibacillus rhamnosus HN001) or placebo for 12 weeks. The primary outcome was a change in HbA1c. Secondary outcomes included changes in anthropometry, body composition, glucoregulatory markers, lipids, hunger hormones, liver enzymes, inflammatory markers, gut hormones, calorie and macronutrient intake, quality of life, hunger, mood and eating behavior. Of 33 participants who commenced the trial, 26 participants (mean age 52 years, body mass index (BMI) 34.7 kg/m 2 ) completed the intervention ( n = 11 placebo, n = 15 probiotic). HbA1c decreased from 43 ± 2.7 mmol/mol to 41 ± 2.3 mmol/mol, p < 0.001, with average of 5% weight loss. No significant between-group differences were seen in primary or secondary outcomes except for social functioning ( p = 0.050) and mental health ( p = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group. This study shows additional psychological benefits of probiotic supplementation during intermittent fasting to achieve weight loss and glycemic improvement in prediabetes.",2020,"No significant between-group differences were seen in primary or secondary outcomes except for social functioning ( p = 0.050) and mental health ( p = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group.","['All participants with HbA1c 40-50 mmol/mol commenced intermittent fasting (2 days per week of calorie restriction to 600-650 kcal/day', 'prediabetes', 'individuals with prediabetes', '33 participants who commenced the trial, 26 participants (mean age 52 years, body mass index (BMI) 34.7 kg/m 2 ) completed the intervention ( n = 11 placebo, n = 15 probiotic', 'People with Prediabetes']","['PROFAST', 'placebo', 'probiotic supplementation', 'Intermittent Fasting and Lacticaseibacillus rhamnosus Probiotic', 'daily probiotic ( Lacticaseibacillus rhamnosus HN001) or placebo', 'intermittent fasting, supplemented with Lacticaseibacillus rhamnosus']","['changes in anthropometry, body composition, glucoregulatory markers, lipids, hunger hormones, liver enzymes, inflammatory markers, gut hormones, calorie and macronutrient intake, quality of life, hunger, mood and eating behavior', 'mental health', 'change in HbA1c', 'social functioning', 'weight loss and glycemic improvement']","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0456649', 'cui_str': 'kcal/day'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0381011', 'cui_str': 'ProFast'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",26.0,0.551726,"No significant between-group differences were seen in primary or secondary outcomes except for social functioning ( p = 0.050) and mental health ( p = 0.007) scores as improvements were seen in the probiotic group, but not in the placebo group.","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tay', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pringle', 'Affiliation': 'Discipline of Nutrition & Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Penning', 'Affiliation': 'Discipline of Nutrition & Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Plank', 'Affiliation': 'Department of Surgery, University of Auckland, Auckland 1142, New Zealand.'}, {'ForeName': 'Rinki', 'Initials': 'R', 'LastName': 'Murphy', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland 1142, New Zealand.'}]",Nutrients,['10.3390/nu12113530']
1612,33212981,Clinical and Microbiological Efficacy of Pyrophosphate Containing Toothpaste: A Double-Blinded Placebo-Controlled Randomized Clinical Trial.,"(1) Background: Dental calculus works as a niche wherein pathogenic bacteria proliferate in the oral cavity. Previous studies revealed the anticalculus activity of pyrophosphates, however there was no clinical study that evaluated microbiome changes associated with calculus inhibition. Therefore, the aim of this randomized clinical trial was to evaluate the calculus inhibition of pyrophosphate-containing toothpaste and its effect on oral microbiome changes. (2) Methods: Eighty subjects with a calculus index ≥2 on the lingual of the mandibular anterior tooth were randomly allocated to the test group that pyrophosphate-containing toothpaste was given to or the placebo control group. Full mouth debridement and standardized tooth brushing instruction were given before the allocation. Plaque index, gingival index, calculus index, probing depth, and bleeding on probing were measured at the baseline, and at 4, 8 and 12 weeks. Genomic DNA was extracted from the plaque samples collected at the baseline and at 12 weeks, and 16S ribosomal RNA gene amplicon sequencing was applied for microbiome analysis. (3) Results: None of the clinical parameters showed significant differences by visits or groups, except the plaque index of the test group, which reduced significantly between 4 and 12 weeks. A significant difference of microbiome between the baseline and 12 weeks was observed in the test group. Between baseline and 12 weeks, the proportion of Spirochetes decreased in the control group, and the proportions of Proteobacteria , Fusobacteria and Spirochetes in the phylum level and the proportions of Haemophilus , Fusobacterium and Capnocytophaga in the genus level decreased in the test group. In the test group, as plaque index decreased, Streptococcus increased, and Fusobacterium and Haemophilus parainfluenza decreased. (4) Conclusion: The use of pyrophosphate-containing toothpaste effectively inhibited the dysbiosis of the oral microbiome and the proliferation of pathogenic species in periodontal disease. Clinically, plaque formation in the pyrophosphate-containing toothpaste group was effectively decreased, however there was no significant change in calculus deposition.",2020,"In the test group, as plaque index decreased, Streptococcus increased, and Fusobacterium and Haemophilus parainfluenza decreased.",['Eighty subjects with a calculus index ≥2 on the lingual of the mandibular anterior tooth'],"['pyrophosphate-containing toothpaste', 'Pyrophosphate Containing Toothpaste', 'Placebo', 'placebo control group']","['calculus deposition', 'proportion of Spirochetes', 'plaque index', 'microbiome', 'plaque formation', 'proportions of Proteobacteria , Fusobacteria and Spirochetes', 'Plaque index, gingival index, calculus index, probing depth, and bleeding on probing', 'plaque index decreased, Streptococcus increased, and Fusobacterium and Haemophilus parainfluenza']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0034320', 'cui_str': 'Pyrophosphate'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0037973', 'cui_str': 'Order Spirochaetales'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0751985', 'cui_str': 'Proteobacteria'}, {'cui': 'C1003893', 'cui_str': 'Fusobacteria'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016878', 'cui_str': 'Fusobacterium'}, {'cui': 'C0018479', 'cui_str': 'Haemophilus'}, {'cui': 'C0030389', 'cui_str': 'Parainfluenza'}]",80.0,0.120283,"In the test group, as plaque index decreased, Streptococcus increased, and Fusobacterium and Haemophilus parainfluenza decreased.","[{'ForeName': 'Inpyo', 'Initials': 'I', 'LastName': 'Hong', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}, {'ForeName': 'Hyun Gee', 'Initials': 'HG', 'LastName': 'Lee', 'Affiliation': 'Safety and Microbiology Lab, Amorepacific R&D Safety and Microbiology Lab, Amorepacific Corporation R&D Center, Yongin 17074, Korea.'}, {'ForeName': 'Hye Lim', 'Initials': 'HL', 'LastName': 'Keum', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Myong Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}, {'ForeName': 'Ui-Won', 'Initials': 'UW', 'LastName': 'Jung', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}, {'ForeName': 'KiJung', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Su Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Taehun', 'Initials': 'T', 'LastName': 'Park', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Jin Ju', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Woo Jun', 'Initials': 'WJ', 'LastName': 'Sul', 'Affiliation': 'Department of Systems Biotechnology, Chung-Ang University, Anseong 17546, Korea.'}, {'ForeName': 'Susun', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Safety and Microbiology Lab, Amorepacific R&D Safety and Microbiology Lab, Amorepacific Corporation R&D Center, Yongin 17074, Korea.'}, {'ForeName': 'Jae-Kook', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, 50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea.'}]",Microorganisms,['10.3390/microorganisms8111806']
1613,33213012,Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial.,"This study aimed to evaluate the efficacy of pitavastatin pretreatment on contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) after a coronary procedure. This was a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical trial. All consecutive 70 patients with CKD (eGFR < 60 mL/min/1.73 m 2 ) were enrolled and randomized into two groups. Group I consisted of patients who were treated with statins (pitavastatin 4 mg/day) for seven days before and three days after the procedure ( n = 37, 52.9%), and group II consisted of patients who were treated with a placebo ( n = 33, 47.1%). The primary endpoint was the incidence of CIN, and the secondary endpoints were the change in serum creatinine (∆sCr) level and estimated glomerular filtration rate (∆eGFR) after the procedure. The mean age of the patients (males, 74%) was 70.4 ± 9.0 years. After the coronary procedure, the incidence of CIN was lower in group I than in group II, but the difference was not significant (5.4% vs. 9.1%, p = 0.661). The maximal ∆sCr was lower and the maximal ∆eGFR was higher in group I than in group II, but the difference was not significant (-0.11 ± 0.53 mg/dL and -0.04 ± 0.33 mg/dL, p = 0.678; 4.3 ± 11.2 mL/min/1.73 m 2 and -2.9 ± 20.4 mL/min/1.73 m 2 , p = 0.161, respectively). This study showed the possibility of a clinical benefit of pretreatment with a high dose of pitavastatin for the prevention of CIN in patients with CKD after coronary procedure (ClinicalTrials.gov Identifier: NCT01871792).",2020,The maximal ∆sCr was lower and the maximal ∆eGFR was higher in group,"['Patients with Renal Dysfunction Undergoing Coronary Procedure', 'patients with CKD after coronary procedure (ClinicalTrials.gov Identifier', 'The mean age of the patients (males, 74%) was 70.4 ± 9.0 years', 'All consecutive 70 patients with CKD (eGFR < 60 mL/min/1.73 m 2 ', 'patients with chronic kidney disease (CKD) after a coronary procedure']","['pitavastatin', 'Pitavastatin', 'placebo', 'statins (pitavastatin']","['incidence of CIN', 'maximal ∆eGFR', 'change in serum creatinine (∆sCr) level and estimated glomerular filtration rate (∆eGFR', 'maximal ∆sCr']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",70.0,0.15508,The maximal ∆sCr was lower and the maximal ∆eGFR was higher in group,"[{'ForeName': 'Woong Chol', 'Initials': 'WC', 'LastName': 'Kang', 'Affiliation': 'Department of Cardiology, Gil Medical Center, Gachon University College of Medicine, Incheon 21565, Korea.'}, {'ForeName': 'Minsu', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon 24253, Korea.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Nowon Eulji Medical Center, Eulji University College of Medicine, Seoul 01830, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Byoung-Kwon', 'Initials': 'BK', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Hyuck Moon', 'Initials': 'HM', 'LastName': 'Kwon', 'Affiliation': 'Department of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}]",Journal of clinical medicine,['10.3390/jcm9113689']
1614,32694184,Restarting CPAP Therapy for Sleep Apnea After a Previous Failure.,"BACKGROUND
About one third of patients fail their first CPAP trial due to several factors. Despite its clinical importance, data on the success of CPAP re-initiation are scarce.
METHODS
Of the 6,231 patients referred to our sleep unit for sleep apnea, we included 224 subjects referred for re-initiation of CPAP therapy (re-CPAP). The control group consisted of 228 CPAP-naïve subjects referred for CPAP initiation. Data on subject characteristics, sleep study, and CPAP outcome were collected.
RESULTS
The re-CPAP group had more severe apnea than the control group. After at least 1 y of CPAP therapy, 52% of the re-CPAP group stayed on therapy; this was significantly lower than the 67% adherence for the control group ( P = .001). No gender difference was observed in the control group ( P = .12), whereas women in the re-CPAP group remained on therapy significantly less than men ( P = .002).
CONCLUSIONS
The percentage of subjects who stayed on CPAP therapy after 1 y was significantly reduced when CPAP was re-initiated compared to the control group. CPAP acceptance after re-initiation was higher among men than women. Further studies are necessary to explain this gender difference.",2020,"No gender difference was observed in the control group ( P = .12), whereas women in the re-CPAP group remained on therapy significantly less than men ( P = .002).
","['224 subjects referred for re-initiation of CPAP therapy (re-CPAP', '6,231 patients referred to our sleep unit for sleep apnea', 'men than women']","['228 CPAP-naïve subjects referred for CPAP initiation', 'Restarting CPAP Therapy']","['CPAP acceptance', 'severe apnea', 'Sleep Apnea']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}]",224.0,0.0300057,"No gender difference was observed in the control group ( P = .12), whereas women in the re-CPAP group remained on therapy significantly less than men ( P = .002).
","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Avellan-Hietanen', 'Affiliation': 'Sleep Unit, Heart and Lung Centre, Helsinki University Hospital, University of Helsinki, Helsinki, Finland. heidi.avellan-hietanen@hus.fi.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Maasilta', 'Affiliation': 'Sleep Unit, Heart and Lung Centre, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Bachour', 'Affiliation': 'Sleep Unit, Heart and Lung Centre, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}]",Respiratory care,['10.4187/respcare.07766']
1615,32701144,Comparison of 3 Devices for 24-Hour Ambulatory Blood Pressure Monitoring in a Nonclinical Environment Through a Randomized Trial.,"BACKGROUND
The U.S. Preventive Services Task Force recommends the use of 24-hour ambulatory blood pressure monitoring (ABPM) as part of screening and diagnosis of hypertension. The optimal ABPM device for population-based surveys is unknown.
METHODS
We compared the proportion of valid blood pressure (BP) readings, mean awake and asleep BP readings, differences between awake ABPM readings and initial standardized BP readings, and sleep experience among three ABPM devices. We randomized a convenience sample of 365 adults to 1 of 3 ABPM devices: Welch Allyn Mobil-O-Graph (WA), Sun Tech Classic Oscar2 (STO) and Spacelabs 90227 (SL). Participants completed sleep quality questionnaires on the nights before and during ABPM testing.
RESULTS
The proportions of valid BP readings were not different among the 3 devices (P > 0.45). Mean awake and asleep systolic BP were significantly higher for STO device (WA vs. STO vs. SL: 126.65, 138.09, 127.44 mm Hg; 114.34, 120.34, 113.13 mm Hg; P < 0.0001 for both). The difference between the initial average standardized mercury systolic BP readings and the ABPM mean awake systolic BP was larger for STO device (WA vs. STO. vs. SL: -5.26, -16.24, -5.36 mm Hg; P < 0.0001); diastolic BP mean differences were ~ -6 mm Hg for all 3 devices (P = 0.6). Approximately 55% of participants reported that the devices interfered with sleep; however, there were no sleep differences across the devices (P > 0.4 for all).
CONCLUSION
Most of the participants met the threshold of 70% valid readings over 24 hours. Sleep disturbance was common but did not interfere with completion of measurement in most of the participants.",2020,The proportions of valid blood pressure readings were not different among the three devices ( p > 0.45).,[],"['24-hour ambulatory blood pressure monitoring (ABPM', 'SL']","['proportions of valid blood pressure readings', 'proportion of valid BP readings, mean awake and asleep BP readings, differences between awake ABPM readings and initial standardized BP readings, and sleep experience', 'Mean awake and asleep systolic BP', 'initial average standardized mercury systolic BP readings and the ABPM mean awake systolic BP', 'Sleep disturbance', 'diastolic BP mean differences']",[],"[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0025424', 'cui_str': 'Mercury'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.0996408,The proportions of valid blood pressure readings were not different among the three devices ( p > 0.45).,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Nwankwo', 'Affiliation': 'Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, CDC, Hyattsville, Maryland, USA.'}, {'ForeName': 'Sallyann M', 'Initials': 'SM', 'LastName': 'Coleman King', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Yechiam', 'Initials': 'Y', 'LastName': 'Ostchega', 'Affiliation': 'Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, CDC, Hyattsville, Maryland, USA.'}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Division of Research and Methodology, National Center for Health Statistics, CDC, Hyattsville, Maryland, USA.'}, {'ForeName': 'Fleetwood', 'Initials': 'F', 'LastName': 'Loustalot', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Gillespie', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Chang', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Elin B', 'Initials': 'EB', 'LastName': 'Begley', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'George', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shimbo', 'Affiliation': 'Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University, Medical Center, New York, New York, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Schwartz', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Applied Behavioral Medicine Research Institute, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Muntner', 'Affiliation': 'Department of Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Kronish', 'Affiliation': 'Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University, Medical Center, New York, New York, USA.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Merritt', 'Affiliation': 'Division for Heart Disease and Stroke Prevention, National Center for Chronic Disease Prevention and Health Promotion, CDC, Atlanta, Georgia, USA.'}]",American journal of hypertension,['10.1093/ajh/hpaa117']
1616,33212111,Exercise training improves microvascular function in patients with Chagas heart disease: Data from the PEACH study.,"BACKGROUND
Chagas heart disease (CHD) impairs the systemic microvascular function. We investigated the effects of exercise training on cutaneous microvascular function among patients with CHD.
METHODS
Patients from the PEACH study were randomly assigned to a supervised exercise training 3 times/week for 6 months (Trained; n = 10) or a control group (Untrained; n = 8). Both groups underwent evaluation of microvascular function before, and at 3- and 6-months of follow-up. Cutaneous vascular conductance (CVC) was assessed in the skin of the forearm using laser speckle contrast imaging coupled with iontophoresis of acetylcholine (ACh), sodium nitroprusside (SNP) and during post-occlusive reactive hyperemia (PORH).
RESULTS
At 3-months of follow-up, no difference was detected between groups in CVC responses to ACh (p = 0.50), SNP (p = 0.26) and HRPO (p = 0.65). However, at 6-months of follow-up, trained vs. untrained patients improved CVC induced by SNP-iontophoresis (0.19 ± 0.10 vs. 0.14 ± 0.15 APU.mmHg -1 ; p = 0.05) and PORH (0.63 ± 0.15 vs. 0.48 ± 0.18 APU.mmHg -1 ; p = 0.05). CVC response to ACh-iontophoresis was similar between groups (0.19 ± 0.11 vs. 0.22 ± 0.17 APU.mmHg -1 ; p = 0.38).
CONCLUSION
Exercise training performed during 6 months improved the cutaneous microvascular function of CHD patients. Further studies evaluating the mechanism involved in this response are warranted.",2020,"At 3-months of follow-up, no difference was detected between groups in CVC responses to ACh (p = 0.50), SNP (p = 0.26) and HRPO (p = 0.65).","['patients with Chagas heart disease', 'Patients from the PEACH study', 'patients with CHD']","['exercise training', 'acetylcholine (ACh), sodium nitroprusside (SNP', 'supervised exercise training 3 times/week for 6\u202fmonths (Trained; n\u202f=\u202f10) or a control group (Untrained; n\u202f=\u202f8', 'Exercise training']","['cutaneous microvascular function', 'CVC responses to ACh', 'PORH', 'CVC response to ACh-iontophoresis', 'HRPO', 'Cutaneous vascular conductance (CVC', 'CVC', 'microvascular function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041234', 'cui_str': 'Infection by Trypanosoma cruzi'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0330659', 'cui_str': 'Prunus persica'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0037533', 'cui_str': 'Sodium nitroprusside'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0456698', 'cui_str': 'times/week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",,0.0358511,"At 3-months of follow-up, no difference was detected between groups in CVC responses to ACh (p = 0.50), SNP (p = 0.26) and HRPO (p = 0.65).","[{'ForeName': 'Juliana Pereira', 'Initials': 'JP', 'LastName': 'Borges', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, RJ, Brazil. Electronic address: julipborges@gmail.com.'}, {'ForeName': 'Fernanda de Souza Nogueira Sardinha', 'Initials': 'FSNS', 'LastName': 'Mendes', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Marcus Vinícius Dos Santos', 'Initials': 'MVDS', 'LastName': 'Rangel', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gabriella de Oliveira', 'Initials': 'GO', 'LastName': 'Lopes', 'Affiliation': 'Laboratory of Physical Activity and Health Promotion, University of Rio de Janeiro State, Rio de Janeiro, RJ, Brazil; Department of Research and Education, National Institute of Cardiology, Ministry of Health, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gilberto Marcelo Sperandio', 'Initials': 'GMS', 'LastName': 'da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Paula Simplício', 'Initials': 'PS', 'LastName': 'da Silva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Mazzoli-Rocha', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Roberto Magalhães', 'Initials': 'RM', 'LastName': 'Saraiva', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Sousa', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Tibirica', 'Affiliation': 'Department of Research and Education, National Institute of Cardiology, Ministry of Health, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Mauro Felippe Felix', 'Initials': 'MFF', 'LastName': 'Mediano', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, RJ, Brazil; Department of Research and Education, National Institute of Cardiology, Ministry of Health, Rio de Janeiro, RJ, Brazil.'}]",Microvascular research,['10.1016/j.mvr.2020.104106']
1617,33212313,Limb and component alignment after total knee arthroplasty comparing 28 consecutive iAssist and 28 conventional TKAs: A prospective study.,"BACKGROUND
The objective of this study was to assess limb and component alignment after total knee arthroplasty (TKA) on long leg X-rays and to compare the use of iAssist, an accelerometric based computer-assisted device (CAD), with conventional jigs.
METHODS
We prospectively recruited 56 consecutive patients undergoing primary unilateral TKA by a single surgeon into this study. In the first 28 patients iAssist navigation system was utilized and in the following 28 conventional jigs were used. The groups were comparable with regard to age, sex distribution, body mass index and preoperative hip-knee-ankle (HKA) angle. Our aim was to restore neutral coronal alignment and a five degree tibial slope.
RESULTS
The mean postoperative mechanical axis was 179.4° in the CAD group and 180.1° in the conventional group (P = 0.187). There were five TKAs deviating more than three degrees from neutral (18.5%) in the conventional group and none in the CAD group (P = 0.051). The mean femoral mechanical-condyles-angle was significantly closer (P < 0.001) to our target of 90° in the conventional group but contained more outliers (P = 0.67). The sagittal tibial slope was closer (P = 0.047) to our target of 85° in CAD-navigated TKAs with fewer outliers (P < 0.0001). The Oxford Knee Score showed comparable (P = 0.271) and good clinical outcome in both groups. The mean operation time was significantly longer in the CAD group (P < 0.001).
CONCLUSIONS
This study shows that the use of iAssist accelerometric CAD facilitates comparable good leg alignment after TKA in the frontal plane and more accurate tibial slope with fewer outliers in the sagittal plane compared with a conventional technique. Our operation time was longer with CAD.",2020,The mean femoral mechanical-condyles-angle was significantly closer (P < 0.001) to our target of 90° in the conventional group but contained more outliers (P = 0.67).,"['total knee arthroplasty comparing 28 consecutive iAssist and 28', '56 consecutive patients undergoing primary unilateral TKA by a single surgeon into this study']","['accelerometric based computer-assisted device (CAD), with conventional jigs', 'conventional TKAs', 'iAssist accelerometric CAD', 'total knee arthroplasty (TKA']","['Oxford Knee Score', 'mean postoperative mechanical axis', 'mean femoral mechanical-condyles-angle', 'sagittal tibial slope', 'mean operation time']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0524414', 'cui_str': 'Structure of condyle'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",56.0,0.0275162,The mean femoral mechanical-condyles-angle was significantly closer (P < 0.001) to our target of 90° in the conventional group but contained more outliers (P = 0.67).,"[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ehrendorfer', 'Affiliation': 'Department of Orthopaedic Surgery, Spital Buelach, Switzerland. Electronic address: stefan.ehrendorfer@spitalbuelach.ch.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Erdmenger', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Leidy Martinez', 'Initials': 'LM', 'LastName': 'Bocanegra', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Boyd', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Canal', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Canal', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Uri (KSU), Altdorf, Switzerland.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Hoch', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Baden (KSB), Baden, Switzerland.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'University Department Orthopaedics and Trauma Surgery, AKH, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Niehaus', 'Affiliation': 'Department of Orthopaedic Surgery, Kantonsspital Baden (KSB), Baden, Switzerland.'}]",The Knee,['10.1016/j.knee.2020.07.101']
1618,33212796,Linkage of Maternal Caregiver Smoking Behaviors on Environmental and Clinical Outcomes of Children with Asthma: A Post-Hoc Analysis of a Financial Incentive Trial Targeting Reduction in Pediatric Tobacco Smoke Exposures.,"(1) Background : Monthly variability in smoking behaviors in caregivers of pediatric asthmatics yields questions of how much and when does smoking reduction result in improved environmental and clinical outcomes. (2) Methods : Post hoc analysis of data from a 6 month pilot randomized-control trial occurring from May 2017 to May 2018 in Baltimore City (MD, USA). The initial trial's primary intervention explored the utility of financial incentives in modifying caregiver smoking behaviors. Post hoc analyses examined all dyads independent of the initial trial's randomization status. All caregivers received pediatric tobacco smoke harm reduction education, in addition to monthly encouragement to access the state tobacco quitline for individual phone-based counseling and nicotine replacement therapy. Maternal caregivers who were active cigarette smokers and their linked asthmatic child (aged 2-12 years) were grouped into two classifications (""high"" versus ""low"") based on the child and caregiver's cotinine levels. A ""low"" cotinine level was designated by at least a 25% reduction in cotinine levels during 3 months of the trial period; achieving ≤2 months of low cotinine levels defaulted to the ""high"" category. Twenty-seven dyads (caregivers and children) (total n = 54) were assigned to the ""high"" category, and eighteen dyads (caregivers and children) (total n = 36) were allocated to the ""low"" category. The primary outcome measure was the correlation of caregiver cotinine levels with pediatric cotinine values. Secondary outcomes included asthma control, in addition to caregiver anxiety and depression. (3) Results : Caregivers with 3 months of ≥25% decrease in cotinine levels had a significantly greater mean change in child cotinine levels ( p = 0.018). ""Low"" caregiver cotinine levels did not significantly improve pediatric asthma control (OR 2.12 (95% CI: 0.62-7.25)). Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization ( p = 0.079); (4) Conclusion : Reduced pediatric cotinine levels were seen in caregivers who reduced their smoking for at least 3 months, but clinical outcome measures remained unchanged.",2020,"Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization ( p = 0.079);","['Maternal caregivers who were active cigarette smokers and their linked asthmatic child (aged 2-12 years', 'Twenty-seven dyads (caregivers and children) ', 'Pediatric Tobacco Smoke Exposures', 'from May 2017 to May 2018 in Baltimore City (MD, USA', 'Children with Asthma', 'total n = 54) were assigned to the ""high"" category, and eighteen dyads (caregivers and children) (total n = 36']","['pediatric tobacco smoke harm reduction education, in addition to monthly encouragement to access the state tobacco quitline for individual phone-based counseling and nicotine replacement therapy']","['child cotinine levels', 'Caregiver anxiety and depression outcomes', 'cotinine levels', 'correlation of caregiver cotinine levels with pediatric cotinine values', 'pediatric cotinine levels', 'pediatric asthma control', 'asthma control, in addition to caregiver anxiety and depression', 'Low"" caregiver cotinine levels', 'Patient Health Questionnaire (PHQ)-4 scores']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3715206', 'cui_str': '18'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",54.0,0.0563195,"Caregiver anxiety and depression outcomes, measured by Patient Health Questionnaire (PHQ)-4 scores, was not significantly different based on cotinine categorization ( p = 0.079);","[{'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Jassal', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Cassia', 'Initials': 'C', 'LastName': 'Lewis-Land', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Butz', 'Affiliation': 'Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17228502']
1619,33212849,Nutritional Bar with Potato-Based Resistant Starch Attenuated Post-Prandial Glucose and Insulin Response in Healthy Adults.,"Resistant starch is a non-digestible starch fraction and is classified as fiber. Beyond naturally occurring fiber sources, starches can be modified to resist digestion, increase their fiber content and provide physiological benefits. The current study examined acute postprandial glycemic responses of VERSAFIBE™ 1490 resistant starch type-4, containing 90% total dietary fiber (TDF, AOAC (Association of Official Analytical Collaboration International) 991.43 method). In a double-blind, randomized, placebo-controlled, cross-over study, healthy adults ( n = 38) consumed a nutritional bar containing either control (2 g), medium (21 g) or high (30 g) fiber. The test bars were matched with control for available carbohydrates, fat and protein. Venous glucose, insulin, and capillary glucose were measured. Mean ± SEM capillary glucose incremental area-under-curve (iAUC0)-120 min in min*mmol/L was lower ( p < 0.005) for both fiber bars (136.2 ± 9.2 and 137.0 ± 10.4 for the medium and high fiber bars, respectively) compared to the control bar (174.9 ± 13.5). Mean venous insulin iAUC0-120 min in min*pmol/L was also lower for medium (8096.3 ± 894.5) and high fiber (7533.8 ± 932.9) bars, respectively, compared to the control bar (11871.6 ± 1123.9, p < 0.001). Peak capillary glucose and venous insulin concentrations were also significantly reduced ( p < 0.001) after consumption of both fiber bars compared to the control bar. The results of this study suggest that nutritional bars containing potato based RS4 fiber reduced post-consumption glycemic and insulinemic responses when consumed by generally healthy adults.",2020,Peak capillary glucose and venous insulin concentrations were also significantly reduced ( p < 0.001) after consumption of both fiber bars compared to the control bar.,"['healthy adults ( n = 38', 'generally healthy adults', 'Healthy Adults']","['consumed a nutritional bar containing either control (2 g), medium (21 g) or high (30 g) fiber', 'placebo', 'Resistant starch', 'nutritional bars containing potato based RS4 fiber', 'Nutritional Bar with Potato-Based Resistant Starch Attenuated Post-Prandial Glucose']","['Mean venous insulin iAUC0', 'Peak capillary glucose and venous insulin concentrations', 'Venous glucose, insulin, and capillary glucose', 'Mean ± SEM capillary glucose incremental area-under-curve (iAUC0)-120 min in min*mmol']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1959943', 'cui_str': '21G'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.0201879,Peak capillary glucose and venous insulin concentrations were also significantly reduced ( p < 0.001) after consumption of both fiber bars compared to the control bar.,"[{'ForeName': 'Vishnupriya', 'Initials': 'V', 'LastName': 'Gourineni', 'Affiliation': 'Global R&D, Ingredion Incorporated, 10 Finderne Ave, Bridgewater, NJ 08807, USA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Stewart', 'Affiliation': 'Global R&D, Ingredion Incorporated, 10 Finderne Ave, Bridgewater, NJ 08807, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'Midwest Biomedical Research, Addison, IL 60101, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL 60101, USA.'}]","Foods (Basel, Switzerland)",['10.3390/foods9111679']
1620,33213492,"Short-term effect of kinesiology taping on pain, functional disability and lumbar proprioception in individuals with nonspecific chronic low back pain: a double-blinded, randomized trial.","BACKGROUND
This study aimed to evaluate the effect of kinesiology taping (KT) on lumbar proprioception, pain, and functional disability in individuals with nonspecific chronic low back pain (CLBP).
METHODS
Thirty individuals with nonspecific CLBP participated in this double-blinded, randomized clinical trial from July 2017 to September 2018. The participants were randomized into two groups: KT (n = 15) and placebo group (n = 15). KT was applied with 15-25% tension for 72 h, and placebo taping was used without tension. Lumbar repositioning error was measured by a bubble inclinometer at three different angles (45° and 60° flexion, and 15° extension) in upright standing. Pain and disability were assessed by the Short-Form McGill Pain Questionnaire and Oswestry Disability Index, respectively. All measurements were recorded at baseline and 3 days after taping.
RESULTS
Pain and disability scores reduced 3 days after taping in the KT group with large effect sizes (p < 0.05). Only the total score of pain was significantly different between the groups 3 days after taping and improved more in the KT group with a large effect size (p < 0.05). However, lumbar repositioning errors were similar between the groups after 3 days (p > 0.05). Also, only constant error of 15° extension showed a moderate correlation with disability (r = 0.39, p = 0.02).
CONCLUSION
KT can decrease pain and disability scores after 3 days of application. Although placebo taping can reduce pain, the effect of KT is higher than placebo taping. The findings do not support the therapeutic effect of KT and placebo taping as a tool to enhance lumbar proprioception in patients with nonspecific CLBP.
TRIAL REGISTRATION
The study prospectively registered on 21.05.2018 at the Iranian Registry of Clinical Trials: IRCT20090301001722N20 .",2020,"RESULTS
Pain and disability scores reduced 3 days after taping in the KT group with large effect sizes (p < 0.05).","['individuals with nonspecific chronic low back pain', 'individuals with nonspecific chronic low back pain (CLBP', 'Thirty individuals with nonspecific CLBP participated in this double-blinded, randomized clinical trial from July 2017 to September 2018', 'patients with nonspecific CLBP']","['kinesiology taping', 'placebo', 'placebo taping', 'KT and placebo', 'kinesiology taping (KT', 'KT']","['lumbar repositioning errors', 'lumbar proprioception', 'total score of pain', 'Lumbar repositioning error', 'Pain and disability scores', 'pain and disability scores', 'lumbar proprioception, pain, and functional disability', 'Pain and disability', 'pain', 'pain, functional disability and lumbar proprioception', 'Short-Form McGill Pain Questionnaire and Oswestry Disability Index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",30.0,0.519787,"RESULTS
Pain and disability scores reduced 3 days after taping in the KT group with large effect sizes (p < 0.05).","[{'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, (TUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Hadian Rasanani', 'Affiliation': 'Postgraduate Department, School of Rehabilitation, Tehran University of Medical Sciences, International, Brain and Spinal Injury Research Center (BASIR), Institute of Neuroscirnce, P.O. Box: 111551683, Tehran, Iran. hadianrs@sina.tums.ac.ir.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Ghotbi', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, (TUMS), Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Olyaei', 'Affiliation': 'Department of Physiotherapy, School of Rehabilitation, Tehran University of Medical Sciences, (TUMS), Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bozorgmehr', 'Affiliation': 'Rehabilitation Research Center, Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rasouli', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00349-y']
1621,33214579,A new fat-dissociation method to detect lymph nodes in colorectal cancer: a prospective randomized study.,"Histological examination of the lymph nodes (LNs) is crucial to determine the colorectal cancer (CRC) stage. We previously reported a new fat-dissociation method (FM) to detect LNs from surgically resected mesentery. This study aimed to examine the effectiveness of FM compared with that of conventional palpation method (PM) in CRC. This single-center, open-label, randomized controlled study was performed at Osaka International Cancer Institute in Japan in 2014. Randomization was performed using a computer-generated permuted-block sequence. Patients were stratified by surgical procedures and the LN dissection area. The primary endpoint was the time required for LN identification. The secondary endpoint was the number of LNs and 5-year cancer-specific survival. The 130 enrolled patients were randomly assigned in a 1:1 ratio to the FM and the PM groups. LN identification times were 45 (range 15-80) and 15 (range 7-30) minutes in the PM and the FM groups, respectively (P < 0.001). In the PM group, body mass index and identification time were correlated (P = 0.047). The number of LN which could be examined pathologically was 16 (range 2-48) and 18 (range 4-95) in the PM and FM groups, respectively (P = 0.546). In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031). Relapse-free survival rates and cancer-specific survival rates did not differ between the groups. In conclusion, FM reduced the time required for LN detection without reducing the number of detected LNs, making it is a useful method to detect LNs in surgical specimens.",2020,"In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031).","['colorectal cancer', 'Osaka International Cancer Institute in Japan in 2014', '130 enrolled patients']","['FM', 'conventional palpation method (PM']","['number of LNs and 5-year cancer-specific survival', 'LN identification times', 'Relapse-free survival rates and cancer-specific survival rates', 'number of LNs', 'body mass index and identification time', 'time required for LN identification']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",130.0,0.0656358,"In right-sided CRC, the number of LNs was higher in the FM group than in the PM group (P = 0.031).","[{'ForeName': 'Shiki', 'Initials': 'S', 'LastName': 'Fujino', 'Affiliation': 'Innovative Oncology Research and Translational Medicine, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Norikatsu', 'Initials': 'N', 'LastName': 'Miyoshi', 'Affiliation': 'Innovative Oncology Research and Translational Medicine, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan. nmiyoshi@gesurg.med.osaka-u.ac.jp.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Ito', 'Affiliation': 'Innovative Oncology Research and Translational Medicine, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Yasui', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Uemura', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Matsuda', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Mizushima', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Eguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.'}, {'ForeName': 'Nariaki', 'Initials': 'N', 'LastName': 'Matsuura', 'Affiliation': 'Department of Surgery, Osaka International Cancer Institute, 3-1-69, Otemae, Chuo-ku, Osaka, 541-8567, Japan.'}]",Scientific reports,['10.1038/s41598-020-77195-8']
1622,33214593,Efficacy of P 11 -4 for the treatment of initial buccal caries: a randomized clinical trial.,"To investigate the safety and efficacy of Self-Assembling Peptide P 11 -4 (SAP P 11 -4) compared to placebo or fluoride varnish (FV), a randomized, controlled, blinded, split-mouth study with sequential design was conducted. Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth were randomly assigned to test or control. Control received placebo at baseline (D0) and test SAP P 11 -4, all received FV at Day 90 (D90). Standardized photographs were taken at each visit, and WSL size changes were morphometrically assessed. Hierarchical Linear Modelling, considering paired and sequential design, was used to test four hypotheses. SAP P 11 -4 lesions (test, D90-D0) showed significant WSL size reduction compared to placebo (control, D90-D0; p = 0.008) or FV (control, D180-D90; p = 0.001). Combination of SAP P 11 -4 and delayed FV after 90 days (test, D180-D0), showed a significant difference compared to FV alone (control D270-D90; p = 0.003). No significant difference on FV efficacy was found when SAP P 11 -4 was applied 3 months before FV (test D270-D90; control D270-D90, p = 0.70). SAP P 11 -4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P 11 -4. SAP P 11 -4 was found to be a safe and effective WSL treatment.",2020,"SAP P 11 -4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P 11 -4.","['initial buccal caries', 'Subjects presenting two teeth with White-Spot-Lesions (WSLs) were included and teeth']","['Self-Assembling Peptide P 11 -4 (SAP P 11 -4', 'placebo or fluoride varnish (FV', 'placebo']","['FV efficacy', 'WSL size reduction', 'SAP P 11 -4 and delayed FV']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0043154', 'cui_str': 'Dental White Spots'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0647980', 'cui_str': 'peptide P (properdin)'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0069877', 'cui_str': 'P 11'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1740186', 'cui_str': 'SKAP2 protein, human'}, {'cui': 'C0069877', 'cui_str': 'P 11'}]",2.0,0.0849517,"SAP P 11 -4 treatment resulted in superior caries regression compared to either placebo or FV, and FV efficacy seems not to be affected by SAP P 11 -4.","[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Sedlakova Kondelova', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Mannaa', 'Affiliation': 'Division of Operative Dentistry, Department of Restorative Dentistry, Faculty of Dentistry, King Abdulaziz University, P.O. Box 80209, Jeddah, 21589, Kingdom of Saudi Arabia.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Bommer', 'Affiliation': 'Credentis AG, Dorfstrasse 69, 5210, Windisch, Switzerland.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Abdelaziz', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Daeniker', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'di Bella', 'Affiliation': 'Department of Political Sciences, University of Genova, P.le E. Brignole 3a, 16126, Genova, Italy.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Krejci', 'Affiliation': 'University of Geneva, University Dental Clinics CUMD, rue Michel-Servet 1, 1211, Geneva 4, Switzerland. Ivo.Krejci@unige.ch.'}]",Scientific reports,['10.1038/s41598-020-77057-3']
1623,33215493,Oral Colonisation after the Administration of Drops Containing Lactobacillus reuteri.,"PURPOSE
To investigate the oral colonisation potential after four weeks' administration of Lactobacillus reuteri and to examine the short-term effect of probiotics on salivary Streptococcus mutans and lactobacilli.
MATERIALS AND METHODS
The study group comprised 13 young adults who volunteered after receiving verbal and written information. The short-term prospective clinical trial lasted 9 weeks, consisting of a 4-week intervention period with administration twice daily and a 5-week post-administration follow-up period with no probiotic consumption. Saliva and dental biofilm samples were obtained immediately before probiotic administration, after 2 weeks and after 4 weeks of L. reuteri administration. Follow-up samples were collected once every week on a regular basis after administration was terminated. The numbers of salivary S. mutans and lactobacilli were assessed by regular plating, while the presence of the two L. reuteri strains in saliva and dental biofilm was evaluated using quantitative polymerase chain reaction (qPCR).
RESULTS
The occurrence of L. reuteri in the oral cavity increased gradually during the intervention period and reached the maximum level after four weeks of probiotic administration (p < 0.0001). The 4-week samples of stimulated whole saliva showed a statistically significant decrease in the number of S. mutans and a statistically significant increase in the salivary lactobacilli level in comparison to baseline. qPCR showed that the DSM 17938 strain has better colonisation for both saliva and dental biofilm than the ATCC PTA 5289 strain at the nine-week follow-up.
CONCLUSION
Probiotics have the ability to colonise the oral cavity during usage, but it gradually disappears after the completion of intake. It also has ability to decrease the number of salivary S. mutans.",2020,"qPCR showed that the DSM 17938 strain has better colonisation for both saliva and dental biofilm than the ATCC PTA 5289 strain at the nine-week follow-up.
",['13 young adults who volunteered after receiving verbal and written information'],['probiotics'],"['Oral Colonisation', 'salivary lactobacilli level', 'occurrence of L. reuteri in the oral cavity', 'number of S. mutans', 'maximum level', 'numbers of salivary S. mutans and lactobacilli', 'Saliva and dental biofilm samples']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",,0.0319071,"qPCR showed that the DSM 17938 strain has better colonisation for both saliva and dental biofilm than the ATCC PTA 5289 strain at the nine-week follow-up.
","[{'ForeName': 'Sahal', 'Initials': 'S', 'LastName': 'Alforaidi', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bresin', 'Affiliation': ''}, {'ForeName': 'Naif', 'Initials': 'N', 'LastName': 'Almosa', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lehrkinder', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a45523']
1624,33215889,Treating Posttraumatic Stress Disorder Symptoms With Low Amplitude Seizure Therapy (LAP-ST) Compared With Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial.,"OBJECTIVES
An important barrier to further studying electroconvulsive therapy (ECT) in posttraumatic stress disorder (PTSD) is the cognitive adverse effects. However, recent data suggest that low amplitude seizure therapy (LAP-ST) has no or minimal cognitive adverse effects. The aims of this report were to examine the efficacy of LAP-ST in PTSD and to compare LAP-ST with standard right unilateral (RUL) ECT using a pilot randomized clinical trial.
METHODS
Patients were randomized to LAP-ST or RUL ECT. Posttraumatic stress disorder was assessed using clinical interview based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and symptom severity with PTSD Checklist (PCL). The scores pertaining to PCL were analyzed using descriptive analysis for this pilot study.
RESULTS
Eleven patients consented to be enrolled. Seven were randomly allocated to LAP-ST or RUL ECT. Five completed the study and had completed PCL before and after the course. In both groups, PTSD symptoms showed fast improvement. The effect size of improvement seems promising. The mean baseline PCL score for patients in the LAP-ST group was 42.5 (SD = 16.26) and the mean end point PCL score after treatment was 31 (SD = 15.56). The mean baseline PCL score for patients in the standard RUL ECT group was 64.7 (SD = 1.15) and the mean end point was 41 (SD = 15.62).
CONCLUSIONS
Both LAP-ST and standard RUL ECT showed reduction in PTSD symptoms with fast improvement. This first PTSD LAP-ST study adds support to the prior LAP-ST proof-of-concept clinical trial that LAP-ST can produce effective therapeutic outcomes. Replication of this trial is warranted in larger clinical trials (ClinicalTrials.gov ID: NCT02583490).",2020,"The mean baseline PCL score for patients in the standard RUL ECT group was 64.7 (SD = 1.15) and the mean end point was 41 (SD = 15.62).
","['posttraumatic stress disorder (PTSD', 'Patients', 'Eleven patients consented to be enrolled']","['Standard Right Unilateral Electroconvulsive Therapy', 'LAP-ST with standard right unilateral (RUL) ECT', 'LAP-ST and standard RUL ECT', 'electroconvulsive therapy (ECT', 'standard RUL ECT', 'low amplitude seizure therapy (LAP-ST', 'Low Amplitude Seizure Therapy (LAP-ST', 'LAP-ST or RUL ECT', 'LAP-ST']","['mean baseline PCL score', 'PTSD symptoms', 'mean end point PCL score', 'Posttraumatic stress disorder', 'Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, and symptom severity with PTSD Checklist (PCL']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0562344', 'cui_str': 'Unilateral electroconvulsive therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",11.0,0.0705082,"The mean baseline PCL score for patients in the standard RUL ECT group was 64.7 (SD = 1.15) and the mean end point was 41 (SD = 15.62).
","[{'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'From the Department of *Psychiatry and Health Behavior †Office of Academic Affairs, Medical College of Georgia at Augusta University ‡Charlie Norwood VA Medical Center, Augusta, GA.'}, {'ForeName': 'Sadiya', 'Initials': 'S', 'LastName': 'Dhanani', 'Affiliation': ''}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': ''}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': ''}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': ''}]",The journal of ECT,['10.1097/YCT.0000000000000701']
1625,33216398,Evaluating an Intervention to Reduce Risky Driving Behaviors: Taking the Fear Out of Virtual Reality.,"Educational programs are the most common type of intervention to reduce risky driving behavior. Their success, however, depends on the content of the material used and the mode of delivery. In the present study, we examined the impact of fear versus positively framed road safety films and traditional technologies (2D) versus emerging technologies (VR) on young drivers' self-reported risky driving behaviors. One hundred and forty-six university students completed a similar set of questionnaires pre-intervention and post-intervention, two weeks later. In addition, they were randomly assigned to one of the four experimental conditions (VR vs. 2D; positive vs. negative). In the VR conditions, the film was presented using an HTC VIVE Virtual Reality headset. In the 2D conditions, the film was presented on a computer screen. Measures evaluating attitudes toward risky driving behavior were completed at both time frames, questions regarding the participants' emotional arousal were asked at pre-intervention as a manipulation check, and questions regarding willingness to take risks in potentially dangerous driving situations were asked at follow-up. The findings indicate that the positively framed films significantly decreased self-reported risky driving behaviors in both modalities, but especially when viewed in VR format. In contrast, the fear appeal film, when shown in VR, failed to reduce risky driving behaviors, and in fact, increased young drivers' self-reported risky driving behaviors. Theoretical frameworks regarding the strengths and weaknesses of fear appeals and positively framed appeals are discussed to aid future research to reduce risky driving. Practical implications on the future usage of VR are also considered.",2020,"The findings indicate that the positively framed films significantly decreased self-reported risky driving behaviors in both modalities, but especially when viewed in VR format.","[""young drivers' self-reported risky driving behaviors"", 'One hundred and forty-six university students']",['fear versus positively framed road safety films and traditional technologies (2D) versus emerging technologies (VR'],"['self-reported risky driving behaviors', 'risky driving behaviors', 'Risky Driving Behaviors', 'attitudes toward risky driving behavior']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.013722,"The findings indicate that the positively framed films significantly decreased self-reported risky driving behaviors in both modalities, but especially when viewed in VR format.","[{'ForeName': 'Clara Alida', 'Initials': 'CA', 'LastName': 'Cutello', 'Affiliation': 'School of Psychology, University of Plymouth, Plymouth, PL4 8AA, UK.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Gummerum', 'Affiliation': 'School of Psychology, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'Yaniv', 'Initials': 'Y', 'LastName': 'Hanoch', 'Affiliation': 'Business School, University of Southampton, Southampton, SO17 1BJ, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hellier', 'Affiliation': 'School of Psychology, University of Plymouth, Plymouth, PL4 8AA, UK.'}]",Risk analysis : an official publication of the Society for Risk Analysis,['10.1111/risa.13643']
1626,33219169,The effectiveness of theory-based intervention to improve haemoglobin levels among women with anaemia in pregnancy.,"BACKGROUND
Anaemia in pregnancy is considered a public health problem throughout the world. The effects of the existing intervention in ensuring compliance to the subscribed regimen and the impact of nutrition education in enhancing dietary modification during pregnancy in Malaysia have been minimal. This study aims to develop, implement and evaluate the effects of the Health Belief Model educational intervention on haemoglobin level among anaemic pregnant women.
METHODS
This is a quasi-experimental research with prepost test design with control group involving 81 participants per group from two health clinics in Sepang. The primary outcome was a change in the haemoglobin levels following educational intervention. Secondary outcomes include knowledge on anaemia, Health Belief Model (HBM) constructs, dietary iron intake and compliance towards iron supplementation. The intervention group received a HBMbased education intervention programme.
RESULTS
The response rate in the intervention and control group were 83.9% and 82.7% respectively. Generalised estimating equations analysis showed that the intervention was effective in improving the mean haemoglobin level (β=0.75, 95%CI=0.52, 0.99, p<0.001), the knowledge score (β=1.42, 95%CI=0.36, 2.49, p=0.009), perceived severity score (β=2.2, 95%CI= 1.02, 3.39, p<0.001) and increased proportion of high compliance level (AOR=4.59, 95%CI=1.58, 13.35, p=0.005).
CONCLUSION
HBM-based health education programme has proven to be effective in improving the haemoglobin levels, knowledge scores, perceived severity scores and compliance level of participants. The study results emphasized on the effectiveness of such an approach, therefore it is recommended that future educational interventions which aim at increasing preventive healthy behaviours in pregnant women may benefit from the application of this model in primary health care settings.",2020,"Generalised estimating equations analysis showed that the intervention was effective in improving the mean haemoglobin level (β=0.75, 95%CI=0.52, 0.99, p<0.001), the knowledge score (β=1.42, 95%CI=0.36, 2.49, p=0.009), perceived severity score (β=2.2, 95%CI= 1.02, 3.39, p<0.001) and increased proportion of high compliance level (AOR=4.59, 95%CI=1.58, 13.35, p=0.005).
","['81 participants per group from two health clinics in Sepang', 'anaemic pregnant women', 'pregnant women', 'women with anaemia in pregnancy']","['Health Belief Model educational intervention', 'HBMbased education intervention programme', 'existing intervention', 'theory-based intervention']","['response rate', 'knowledge on anaemia, Health Belief Model (HBM) constructs, dietary iron intake and compliance towards iron supplementation', 'mean haemoglobin level', 'haemoglobin levels', 'knowledge score', 'perceived severity score', 'proportion of high compliance level', 'haemoglobin level']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0857322', 'cui_str': 'Anemic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271930', 'cui_str': 'Anemia of pregnancy'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3714363', 'cui_str': 'Health belief model'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}, {'cui': 'C0376520', 'cui_str': 'Dietary Iron'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205250', 'cui_str': 'High'}]",81.0,0.0911541,"Generalised estimating equations analysis showed that the intervention was effective in improving the mean haemoglobin level (β=0.75, 95%CI=0.52, 0.99, p<0.001), the knowledge score (β=1.42, 95%CI=0.36, 2.49, p=0.009), perceived severity score (β=2.2, 95%CI= 1.02, 3.39, p<0.001) and increased proportion of high compliance level (AOR=4.59, 95%CI=1.58, 13.35, p=0.005).
","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hasneezah', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Rosliza', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, 43400 Serdang, Selangor, Malaysia. rosliza_abmanaf@upm.edu.my.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Salmiah', 'Affiliation': 'IUniversiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Community Health, 43400 Serdang, Selangor, Malaysia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Appanah', 'Affiliation': 'Universiti Putra Malaysia, Faculty of Medicine and Health Sciences, Department of Nutrition and Dietetics, 43400 Serdang, Selangor, Malaysia.'}]",The Medical journal of Malaysia,[]
1627,33217070,A pilot study of mobilized intervention to help caregivers of oncology patients manage distress.,"OBJECTIVE
Caregivers of patients with advanced cancer experience significant anxiety, depression, and distress. Caregivers have barriers to accessing in-person treatment to manage stress. Technology allows for the dissemination of evidence-based interventions in a convenient way. This study examined usage rates of Pep-Pal (an evidence-based mobilized intervention to help caregivers of patients with advanced cancer manage distress) and estimates of efficacy on anxiety, depression, stress, and sexual dysfunction.
METHODS
Fifty-six primary caregivers of patients with advanced cancer were recruited through oncology clinics and randomized to either Pep-Pal (a mobilized psychoeducation and skills-based intervention for caregivers, n = 26) or treatment as usual (TAU; n = 30). All were screened for moderate anxiety on the Hospital Anxiety and Depression Scale-Anxiety screening assessment (A ≥ 8) at baseline.
RESULTS
Participants randomized to Pep-Pal experienced greater reductions in perceived stress (PSS; F = 3.91, p = .05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU. Of Pep-Pal participants, only 10 (38.5%) watched at least 7/9 full-length sessions. The a priori hypothesis and criterion that participants would watch at least 75% full-length sessions were not met.
CONCLUSIONS
A brief, easily disseminated mobile intervention showed poor adherence, but had limited estimates of efficacy for secondary outcomes; perceived stress, learning stress management skills, and sexual functioning (women only). Future directions are discussed.",2020,"RESULTS
Participants randomized to Pep-Pal experienced greater reductions in perceived stress (PSS F = 3.91, p=.05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU.","['Help Caregivers of Oncology Patients Manage Distress', 'patients with advanced cancer manage distress', 'patients with advanced cancer experience significant anxiety, depression, and distress', 'Fifty-six primary caregivers of patients with advanced cancer were recruited through oncology clinics and randomized to either']","['Mobilized Intervention', 'Pep-Pal (a mobilized psychoeducation and skills-based intervention for caregivers, n= 26) or treatment as usual (TAU, n= 30', 'Pep-Pal (an evidence-based mobilized intervention']","['ability to learn and use stress management skills', 'sexual function', 'perceived stress', 'anxiety, depression, stress, and sexual dysfunction', 'stress, learning stress management skills, and sexual functioning']","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C0030360', 'cui_str': 'Papillon-Lefèvre syndrome'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",56.0,0.0626445,"RESULTS
Participants randomized to Pep-Pal experienced greater reductions in perceived stress (PSS F = 3.91, p=.05), greater increases in ability to learn and use stress management skills (F = 6.16, p = 0.01), and greater increases in sexual function (women only; F = 5.07, p = 0.03) compared to participants in TAU.","[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Pensak', 'Affiliation': 'Atlantic Coast Mind & Body, Red Bank, New Jersey, USA.'}, {'ForeName': 'Alaina L', 'Initials': 'AL', 'LastName': 'Carr', 'Affiliation': 'University of Colorado-Denver, Denver, Colorado, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'College of Nursing, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Mikulich-Gilbertson', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kilbourn', 'Affiliation': 'University of Colorado-Denver, Denver, Colorado, USA.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Sannes', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Benjamin B', 'Initials': 'BB', 'LastName': 'Brewer', 'Affiliation': 'Division of Hematology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Elissa', 'Initials': 'E', 'LastName': 'Kolva', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Tanisha', 'Initials': 'T', 'LastName': 'Joshi', 'Affiliation': 'Division of Hematology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Laudenslager', 'Affiliation': 'Department of Psychiatry, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}]",Psycho-oncology,['10.1002/pon.5597']
1628,33217532,Effect of consumer's decisions on acrylamide exposure during the preparation of French fries. part 1: Frying conditions.,"Variability in home-cooking practices affects dietary exposure to acrylamide, limiting risk evaluation. Two observational tests (controlled and randomized) involving 127 volunteers was designed to investigate the influence of consumer decisions on acrylamide formation during the preparation of French fries. Consumer practices were recorded during pre-frying, frying and post-frying stages. Reducing sugar content, asparagine, moisture, acrylamide, moisture, weight loss and color were evaluated. In the controlled assay, mean acrylamide content was 508 μg/kg and volunteers took a mean frying time of 91.9 s (87.5-96.4, C.I. 95%). The narrow confidence interval of 8.9 s represented an increase of 120 μg/kg in the acrylamide content of the fried potato. Average acrylamide content in the randomized assay (215 μg/kg, 150-280 μg/kg, C.I. 95%) was significantly lower than in the controlled assay. Amongst the culinary practices applied for the potato variety evaluated, washing of the potato strips significantly reduced acrylamide content in French fries. The percentage of samples with acrylamide lower than the benchmark value (500 μg/kg) was 54% and 93% for the controlled and randomized assays, respectively. Estimated average dietary exposure to acrylamide from French fries in adults was 5.65 μg/day, which corresponds to a margin of exposure of 2105 for carcinogenicity.",2020,"Amongst the culinary practices applied for the potato variety evaluated, washing of the potato strips significantly reduced acrylamide content in French fries.","['127 volunteers', 'French fries']",[],"['Reducing sugar content, asparagine, moisture, acrylamide, moisture, weight loss and color', 'Average acrylamide content', 'mean acrylamide content']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1510451', 'cui_str': 'French fries'}]",[],"[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0003995', 'cui_str': 'Asparagine'}, {'cui': 'C0001218', 'cui_str': 'Acrylamides'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",127.0,0.0417331,"Amongst the culinary practices applied for the potato variety evaluated, washing of the potato strips significantly reduced acrylamide content in French fries.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mesias', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Delgado-Andrade', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Holgado', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'González-Mulero', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Morales', 'Affiliation': 'Institute of Food Science, Technology and Nutrition (ICTAN-CSIC), Madrid, Spain. Electronic address: fjmorales@ictan.csic.es.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111857']
1629,33217700,Piloting the 'Youth Early-intervention Study' ('YES'): Preliminary functional outcomes of a randomized controlled trial targeting social participation and physical well-being in young people with emerging mental disorders.,"INTRODUCTION
Young people with mental disorders present with diverse social, vocational, physical, and developmental needs. However, multifaceted interventions are rare. We examine the effectiveness of a clinical trial targeting social participation and physical well-being in young people accessing clinical services.
METHODS
The 'Youth Early-intervention Study' ('YES') was an unblinded, two-phase, pilot randomized controlled trial offered as an adjunct to standard clinical care, consisting of group activities. Mixed effects models were used to examine functional outcomes over time measured by the 'Social and Occupational Functioning Assessment Scale', 'Functioning Assessment Short Test', and 'Brief Disability Questionnaire' (items 7 and 8).
RESULTS
133 participants aged 14-25 were recruited. 87 participants completed both arms and 83 participants completed a 12-month post-trial assessment. Functioning improved across all outcomes. While diagnoses differed in functioning at baseline (lower functioning in psychotic and bipolar disorders compared to depression), they did not differ in the rate of improvement across any measure. Randomization groups did not differ in baseline functioning or the rate of improvement, suggesting a non-specific impact of the intervention. Engagement with education increased from 11% at baseline to 51% at 12-months post-trial and full-time employment increased from 8% at baseline to 20% at 12-months post-trial.
LIMITATIONS
Small sample, no control group, and unmeasured potential moderators (e.g. neurocognitive impairment).
CONCLUSIONS
'YES' was effective and preliminary positive outcomes were observed across all functional outcomes. Future studies should compare the 'YES' intervention to a treatment-as-usual control condition and conduct a multi-centre trial across early intervention service sites.",2020,"Randomization groups did not differ in baseline functioning or the rate of improvement, suggesting a non-specific impact of the intervention.","['young people with emerging mental disorders', 'young people accessing clinical services', '87 participants completed both arms and 83 participants completed a 12-month post-trial assessment', '133 participants aged 14-25 were recruited', 'Young people with mental disorders']",[],"['full-time employment', ""Social and Occupational Functioning Assessment Scale', 'Functioning Assessment Short Test', and 'Brief Disability Questionnaire' (items 7 and 8"", 'Engagement with education']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",133.0,0.163707,"Randomization groups did not differ in baseline functioning or the rate of improvement, suggesting a non-specific impact of the intervention.","[{'ForeName': 'Lillian J', 'Initials': 'LJ', 'LastName': 'Gehue', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Crouse', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia. Electronic address: jacob.crouse@sydney.edu.au.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Battisti', 'Affiliation': ""Cancer Centre for Children, The Children's Hospital at Westmead, NSW, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Yim', 'Affiliation': ""St Vincent's Private Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Carpenter', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': ""Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia; St Vincent's and Mater Clinical School, The University of Notre Dame, NSW, Australia.""}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Hickie', 'Affiliation': 'Youth Mental Health and Technology Team, Brain and Mind Centre, University of Sydney, NSW, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2020.10.070']
1630,33217717,"Weight stigma and media: An examination of the effect of advertising campaigns on weight bias, internalized weight bias, self-esteem, body image, and affect.","While some media perpetuate weight stigma and an ideal of thinness, certain advertising campaigns, such as Aerie Real and Dove Real Beauty, have attempted to promote body acceptance. The current study evaluated the influence of exposure to these campaigns on weight bias, internalized weight bias (IWB), self-esteem, body image, and affect relative to exposure to a campaign perpetuating the thin ideal and a documentary on weight stigma. 475 female participants were randomized to one of five conditions: Aerie, Dove, Victoria's Secret, an HBO documentary, or control (i.e., neutral video clip). Participants completed measures of weight bias, IWB, self-esteem, body image, and affect one week prior to and immediately after watching the assigned video clip. Results showed positive effects of the Aerie and Dove campaigns on women. While global measures of weight bias and IWB were unchanged, women who viewed the Dove and Aerie campaigns reported significantly improved self-esteem and positive affect. Further, women found the campaigns to have positive, uplifting, and empowering messages. Aerie's and Dove's acceptance-promoting advertising campaigns positively influenced self-esteem and mood, and they are potential tools for weight bias reduction. Advertisements and media have the potential to impact weight-based attitudes in society.",2020,"While global measures of weight bias and IWB were unchanged, women who viewed the Dove and Aerie campaigns reported significantly improved self-esteem and positive affect.",['475 female participants'],"[""Dove, Victoria's Secret, an HBO documentary, or control (i.e., neutral video clip""]","['Weight stigma and media', 'self-esteem', 'weight bias, internalized weight bias (IWB), self-esteem, body image', 'weight bias, internalized weight bias, self-esteem, body image, and affect', 'weight bias and IWB', 'weight bias, IWB, self-esteem, body image']","[{'cui': 'C4517786', 'cui_str': '475'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0325912', 'cui_str': 'Family Columbidae'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",475.0,0.0279557,"While global measures of weight bias and IWB were unchanged, women who viewed the Dove and Aerie campaigns reported significantly improved self-esteem and positive affect.","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Selensky', 'Affiliation': 'East Carolina University, East Fifth Street, 104 Rawl Building, Greenville, NC 27858, United States. Electronic address: selenskyj15@ecualumni.ecu.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Carels', 'Affiliation': 'East Carolina University, East Fifth Street, 104 Rawl Building, Greenville, NC 27858, United States.'}]",Body image,['10.1016/j.bodyim.2020.10.008']
1631,33217826,Effects of progressive muscle relaxation training on negative emotions and sleep quality in COVID-19 patients: A clinical observational study.,"This study investigates the effect of progressive muscle relaxation training on negative mood and sleep quality in Coronavirus Pneumonia (COVID-19) patients.COVID-19 is an emerging infectious disease, and there is still uncertainty about when the outbreak will be contained and the effectiveness of treatments. Considering that this disease is highly contagious, patients need to be treated in isolation. This may lead to psychological symptoms such as anxiety and depression, and even sleep problems.This study is a clinical observation study.Participants included 79 COVID-19 patients admitted to a designated hospital for COVID-19 patients in Wuhan from February to March, 2020. Patients were selected and assigned to the control group and the observation group according to their wishes, with 40 and 39 cases in each group, respectively. The control group received routine treatment and nursing, and the observation group received progressive muscle relaxation training, in addition to the routine treatment and nursing. We compared scores of the Pittsburgh Sleep Quality Index Scale (PSQI), the Generalized Anxiety Disorder (GAD-7), and the Patient Health Questionnaire (PHQ-9) before and after the intervention.There was no significant difference in PSQI, GAD-7, and PHQ-9 scores between the control group and the observation group before the intervention (P > .05). After the intervention, the difference in scores of PSQI, GAD-7, and PHQ-9 in the 2 groups were statistically significant (P < .05).Progressive muscle relaxation training can significantly reduce anxiety and depression and improve sleep quality in COVID-19 patients during isolation treatment.Progressive muscle relaxation training was shown to improve the treatment effect of patients and is worthy of clinical promotion.",2020,"There was no significant difference in PSQI, GAD-7, and PHQ-9 scores between the control group and the observation group before the intervention (P > .05).","['COVID-19 patients', 'Participants included 79 COVID-19 patients admitted to a designated hospital for COVID-19 patients in Wuhan from February to March, 2020', 'Coronavirus Pneumonia (COVID-19) patients']","['progressive muscle relaxation training', 'Progressive muscle relaxation training', 'routine treatment and nursing, and the observation group received progressive muscle relaxation training']","['negative mood and sleep quality', 'Pittsburgh Sleep Quality Index Scale (PSQI), the Generalized Anxiety Disorder (GAD-7), and the Patient Health Questionnaire (PHQ-9', 'scores of PSQI, GAD-7, and PHQ-9', 'negative emotions and sleep quality', 'anxiety and depression and improve sleep quality', 'PSQI, GAD-7, and PHQ-9 scores']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",79.0,0.0155146,"There was no significant difference in PSQI, GAD-7, and PHQ-9 scores between the control group and the observation group before the intervention (P > .05).","[{'ForeName': 'Chun-Xiu', 'Initials': 'CX', 'LastName': 'Xiao', 'Affiliation': 'Nursing Department.'}, {'ForeName': 'Yan-Juan', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Nursing Department.'}, {'ForeName': 'Ren-Qin', 'Initials': 'RQ', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'An-Na', 'Initials': 'AN', 'LastName': 'Liu', 'Affiliation': 'Department of Burns.'}, {'ForeName': 'Gui-Qin', 'Initials': 'GQ', 'LastName': 'Zhong', 'Affiliation': 'Department of Neurosurgery.'}, {'ForeName': 'Cai-Feng', 'Initials': 'CF', 'LastName': 'Lan', 'Affiliation': 'Department of Obstetrics and Gynecology of Fujian Medical University Union Hospital, Fuzhou City, Fujian Province, China.'}]",Medicine,['10.1097/MD.0000000000023185']
1632,33220216,"Cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine versus single screening and treatment for the control of malaria in pregnancy in Papua, Indonesia: a provider perspective analysis from a cluster-randomised trial.","BACKGROUND
Malaria infection during pregnancy is associated with serious adverse maternal and birth outcomes. A randomised controlled trial in Papua, Indonesia, comparing the efficacy of intermittent preventive treatment with dihydroartemisinin-piperaquine with the current strategy of single screening and treatment showed that intermittent preventive treatment is a promising alternative treatment for the reduction of malaria in pregnancy. We aimed to estimate the incremental cost-effectiveness of intermittent preventive treatment with dihydroartemisinin-piperaquine compared with single screening and treatment with dihydroartemisinin-piperaquine.
METHODS
We did a provider perspective analysis. A decision tree model was analysed from a health provider perspective over a lifetime horizon. Model parameters were used in deterministic and probabilistic sensitivity analyses. Simulations were run in hypothetical cohorts of 1000 women who received intermittent preventive treatment or single screening and treatment. Disability-adjusted life-years (DALYs) for fetal loss or neonatal death, low birthweight, moderate or severe maternal anaemia, and clinical malaria were calculated from trial data and cost estimates in 2016 US dollars from observational studies, health facility costings and public procurement databases. The main outcome measure was the incremental cost per DALY averted.
FINDINGS
Relative to single screening and treatment, intermittent preventive treatment resulted in an incremental cost of US$5657 (95% CI 1827 to 9448) and 107·4 incremental DALYs averted (-719·7 to 904·1) per 1000 women; the average incremental cost-effectiveness ratio was $53 per DALY averted.
INTERPRETATION
Intermittent preventive treatment with dihydroartemisinin-piperaquine offers a cost-effective alternative to single screening and treatment for the prevention of the adverse effects of malaria infection in pregnancy in the context of the moderate malaria transmission setting of Papua. The higher cost of intermittent preventive treatment was driven by monthly administration, as compared with single-administration single screening and treatment. However, acceptability and feasibility considerations will also be needed to inform decision making.
FUNDING
Medical Research Council, Department for International Development, and Wellcome Trust.",2020,"The higher cost of intermittent preventive treatment was driven by monthly administration, as compared with single-administration single screening and treatment.","['1000 women who received', 'malaria in pregnancy in Papua, Indonesia']","['single screening and treatment with dihydroartemisinin-piperaquine', 'intermittent preventive treatment or single screening and treatment', 'dihydroartemisinin-piperaquine versus single screening and treatment', 'dihydroartemisinin-piperaquine']","['Cost-effectiveness', 'incremental cost per DALY averted', 'Disability-adjusted life-years (DALYs) for fetal loss or neonatal death, low birthweight, moderate or severe maternal anaemia, and clinical malaria', 'average incremental cost-effectiveness ratio']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0747820', 'cui_str': 'Malaria, antepartum'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4543807', 'cui_str': 'Clinical malaria'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.161322,"The higher cost of intermittent preventive treatment was driven by monthly administration, as compared with single-administration single screening and treatment.","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Paintain', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: lucy.paintain@lshtm.ac.uk.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Rukhsana', 'Initials': 'R', 'LastName': 'Ahmed', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK; Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Chandra', 'Initials': 'C', 'LastName': 'Umbu Reku Landuwulang', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Ansariadi', 'Initials': 'A', 'LastName': 'Ansariadi', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia; Department of Epidemiology, School of Public Health, Hasanuddin University, Makassar, Indonesia.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Rini Poespoprodjo', 'Affiliation': 'Mimika District Health Authority, Timika, Papua, Indonesia; Timika Malaria Research Program, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia; Pediatric Research Office, Department of Child Health, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Din', 'Initials': 'D', 'LastName': 'Syafruddin', 'Affiliation': 'Eijkman Institute for Molecular Biology, Jakarta, Indonesia.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Khairallah', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Faustina Helena', 'Initials': 'FH', 'LastName': 'Burdam', 'Affiliation': 'Mimika District Health Authority, Timika, Papua, Indonesia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bonsapia', 'Affiliation': 'Timika Malaria Research Program, Papuan Health and Community Development Foundation, Timika, Papua, Indonesia.'}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': 'Disease Control Department, London School of Hygiene and Tropical Medicine, London, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30386-7']
1633,33220217,Effect of a mobile phone intervention for female sex workers on unintended pregnancy in Kenya (WHISPER or SHOUT): a cluster-randomised controlled trial.,"BACKGROUND
Female sex workers in low-income and middle-income countries face high risks of unintended pregnancy. We developed a 12-month, multifaceted short messaging service intervention (WHISPER) for female sex workers in Kenya who had the potential to become pregnant, to improve their contraceptive knowledge and behaviours. The aim of this study was to assess the effectiveness of the intervention to reduce the incidence of unintended pregnancy among sex workers in Kenya compared with an equal-attention control group receiving nutrition-focused messages (SHOUT).
METHODS
Our two-arm, cluster-randomised controlled trial was done in sex-work venues in two subcounties of Mombasa, Kenya (Kisauni and Changamwe). Participants, aged 16-34 years, not pregnant or planning pregnancy, able to read text messages in English, residing in the study area, and who had a personal mobile phone with one of two phone networks, were recruited from 93 randomly selected sex-work venues (clusters). Random cluster allocation (1:1) to the intervention or control group was concealed from participants and researchers until the intervention started. Both groups received text messages in English delivered two to three times per week for 12 months (137 messages in total), as well as additional on-demand messages. Message content in the intervention group focused on promotion of contraception, particularly long-acting reversible contraception and dual method contraceptive use; message content in the control group focused on promotion of nutritional knowledge and practices, including food safety, preparation, and purchasing. The primary endpoint, analysed in all participants who were randomly assigned and attended at least one follow-up visit, compared unintended pregnancy incidence between groups using discrete-time survival analysis at 6 and 12 months. This trial is registered with Australian New Zealand Clinical Trials Registry, ACTRN12616000852459, and is closed to new participants.
FINDINGS
Between Sept 14, 2016, and May 16, 2017, 1728 individuals were approached to take part in the study. Of these, 1155 were eligible for full screening, 1035 were screened, and 882 were eligible, enrolled, and randomly assigned (451 participants from 47 venues in the intervention group; 431 participants from 46 venues in the control group). 401 participants from the intervention group and 385 participants from the control group were included in the primary analysis. Incidence of unintended pregnancy was 15·5 per 100 person-years in the intervention group and 14·7 per 100 person-years in the control group (hazard ratio 0·98, 95% CI 0·69-1·39).
INTERPRETATION
The intervention had no measurable effect on unintended pregnancy incidence. Mobile health interventions, even when acceptable and rigorously designed, are unlikely to have a sufficient effect on behaviour among female sex workers to change pregnancy incidence when used in isolation.
FUNDING
National Health and Medical Research Council of Australia.",2020,"Mobile health interventions, even when acceptable and rigorously designed, are unlikely to have a sufficient effect on behaviour among female sex workers to change pregnancy incidence when used in isolation.
","['1155 were eligible for full screening, 1035 were screened, and 882 were eligible, enrolled, and randomly assigned (451 participants from 47 venues in the intervention group; 431 participants from 46 venues in the control group', 'Our two-arm, cluster-randomised controlled trial was done in sex-work venues in two subcounties of Mombasa, Kenya (Kisauni and Changamwe', 'Female sex workers in low-income and middle-income countries', 'Participants, aged 16-34 years, not pregnant or planning pregnancy, able to read text messages in English, residing in the study area, and who had a personal mobile phone with one of two phone networks, were recruited from 93 randomly selected sex-work venues (clusters', 'female sex workers in Kenya who had the potential to become pregnant, to improve their contraceptive knowledge and behaviours', 'female sex workers', '1728 individuals were approached to take part in the study', '401 participants from the intervention group and 385 participants from the control group were included in the primary analysis', 'sex workers in Kenya compared with an', 'female sex workers on unintended pregnancy in Kenya (WHISPER or SHOUT']","['equal-attention control group receiving nutrition-focused messages (SHOUT', 'multifaceted short messaging service intervention (WHISPER', 'mobile phone intervention']","['Incidence of unintended pregnancy', 'unintended pregnancy incidence']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0032992', 'cui_str': 'Pregnant - planned'}, {'cui': 'C0586740', 'cui_str': 'Able to read'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4517751', 'cui_str': '385'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0240816', 'cui_str': 'Sex worker'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}, {'cui': 'C0234766', 'cui_str': 'Whispering'}, {'cui': 'C0562551', 'cui_str': 'Shouting'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0562551', 'cui_str': 'Shouting'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0234766', 'cui_str': 'Whispering'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041747', 'cui_str': 'Unplanned pregnancy'}]",1728.0,0.17885,"Mobile health interventions, even when acceptable and rigorously designed, are unlikely to have a sufficient effect on behaviour among female sex workers to change pregnancy incidence when used in isolation.
","[{'ForeName': 'Frances H', 'Initials': 'FH', 'LastName': 'Ampt', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Megan S C', 'Initials': 'MSC', 'LastName': 'Lim', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Agius', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': ""L'Engle"", 'Affiliation': 'Department of Health Professions, University of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Griffins', 'Initials': 'G', 'LastName': 'Manguro', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Gichuki', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gichangi', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya; Technical University of Mombasa, Mombasa, Kenya; Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Chersich', 'Affiliation': 'Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Jaoko', 'Affiliation': 'Department of Medical Microbiology, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Temmerman', 'Affiliation': 'International Centre for Reproductive Health, Mombasa, Kenya; Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium; Department of Obstetrics and Gynecology, Aga Khan University, Nairobi, Kenya.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stoové', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia; School of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Hellard', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Infectious Diseases, The Alfred Hospital, Melbourne, VIC, Australia.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Luchters', 'Affiliation': 'Burnet Institute, Melbourne, VIC, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Public Health and Primary Care, International Centre for Reproductive Health, Ghent University, Ghent, Belgium; Department of Population Health, Aga Khan University, Nairobi, Kenya. Electronic address: stanley.luchters@aku.edu.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30389-2']
1634,33220252,The Colombian chemoprevention trial. Twenty-year follow-up of a cohort of patients with gastric precancerous lesions.,"BACKGROUND AND AIMS
Helicobacter pylori eradication and endoscopic surveillance of gastric precancerous lesions are strategies to reduce gastric cancer (GC) risk. This study is the longest prospective cohort of an H. pylori eradication trial in a Hispanic population.
METHODS
800 adults with precancerous lesions were randomized to anti-H. pylori treatment or placebo. Gastric biopsies at baseline, 3, 6, 12, 16, and 20 years were assessed by our Correa histopathology score. A generalized linear mixed model with a subject level random intercept was used to estimate the effect of H. pylori status on the score over time. Logistic regression models were used to estimate progression by baseline diagnosis, and GC risk by intestinal metaplasia (IM) subtype and anatomic location.
RESULTS
356 individuals completed 20 years of follow-up. Anti-H. pylori therapy (intention-to-treat) reduced progression of the Correa score (odds ratio OR, 0.59, 95% confidence interval, CI, 0.38-0.93). H. pylori-negative status had a beneficial effect on the score over time (P=0.036). Among individuals with IM (including indefinite for dysplasia) at baseline, incidence rates per 100 person-years were 1.09 (95% CI, 0.85-1.33) for low-grade/high-grade dysplasia and 0.14 (95% CI, 0.06-0.22) for GC. Incomplete-type (vs. complete-type) IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8). Individuals with corpus (vs. antrum-restricted) IM showed an OR of 2.1 (95% CI, 0.7-6.6) for GC.
CONCLUSIONS
In a high GC risk Hispanic population, anti-H. pylori therapy had a long-term beneficial effect against histological progression. Incomplete IM is a strong predictor of GC risk.",2020,"IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8).","['800 adults with precancerous lesions', 'Hispanic population', 'Individuals with corpus (vs. antrum-restricted', 'patients with gastric precancerous lesions', '356 individuals completed 20 years of follow-up']",['anti-H. pylori treatment or placebo'],"['GC risk by intestinal metaplasia (IM) subtype and anatomic location', 'progression of the Correa score (odds ratio', 'GC risk']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034193', 'cui_str': 'Pyloric antrum structure'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0334037', 'cui_str': 'Intestinal metaplasia'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",800.0,0.177121,"IM at baseline presented higher GC risk (OR, 13.4; 95% CI, 1.8-103.8).","[{'ForeName': 'M Blanca', 'Initials': 'MB', 'LastName': 'Piazuelo', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: maria.b.piazuelo@vumc.org.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Bravo', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Robertino M', 'Initials': 'RM', 'LastName': 'Mera', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'M Constanza', 'Initials': 'MC', 'LastName': 'Camargo', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD, USA.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Bravo', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Alberto G', 'Initials': 'AG', 'LastName': 'Delgado', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'M Kay', 'Initials': 'MK', 'LastName': 'Washington', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Rosero', 'Affiliation': 'Universidad de Nariño, Pasto, Nariño, Colombia.'}, {'ForeName': 'Luz S', 'Initials': 'LS', 'LastName': 'Garcia', 'Affiliation': 'Department of Pathology, Universidad del Valle School of Medicine, Cali, Valle del Cauca, Colombia.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Realpe', 'Affiliation': 'Fundación Hospital San Pedro, Pasto, Nariño, Colombia.'}, {'ForeName': 'Sandra P', 'Initials': 'SP', 'LastName': 'Cifuentes', 'Affiliation': 'Fundación Hospital San Pedro, Pasto, Nariño, Colombia.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Morgan', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Division of Gastroenterology, Department of Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Peek', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Pelayo', 'Initials': 'P', 'LastName': 'Correa', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Keith T', 'Initials': 'KT', 'LastName': 'Wilson', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA; Center for Mucosal Inflammation and Cancer, Vanderbilt University Medical Center, Nashville, TN, USA; Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, TN, USA; Veterans Affairs Tennessee Valley Healthcare System, Nashville, TN, USA.'}]",Gastroenterology,['10.1053/j.gastro.2020.11.017']
1635,33220568,Comparison of health service use trajectories of residential aged care residents reviewed by a hospital avoidance program versus usual care.,"OBJECTIVE
To compare health service use trajectories of residential aged care facility (RACF) residents reviewed by the Aged Care Rapid Response Team (ARRT) to RACF residents who received usual care.
METHODS
A retrospective group-based trajectory analysis of RACF residents aged ≥65 years who were reviewed by ARRT during 1 July 2015 to 30 June 2016 was conducted. Health service use trajectories were followed for two years to 30 June 2018 and compared to RACF residents aged ≥65 years who lived in the same Local Health District and received usual care.
RESULTS
There were 2,245 ARRT-reviewed resident hospitalisations and 11,892 usual care resident hospital admissions during 2015-16. Trajectory analysis categorised ARRT-reviewed residents into four groups and usual care residents into three groups. Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents. Additionally, gender predicted group membership in ARRT-reviewed RACF residents and fall-related injuries predicted group membership in usual care RACF residents.
CONCLUSION
The identification of health service use trajectories assists in understanding hospital use by older RACF residents and may offer guidance in the design of prevention measures, including hospital avoidance programs.",2020,"Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents.","['residential aged care facility (RACF) residents reviewed by the Aged Care Rapid Response Team (ARRT) to RACF residents who received usual care', 'Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents', 'residential aged care residents', 'RACF residents aged ≥65 years who were reviewed by ARRT during 1 July 2015 to 30 June 2016 was conducted', 'residents aged ≥65 years who lived in the same Local Health District and received usual care', 'Trajectory analysis categorised ARRT-reviewed residents into four groups and usual care residents into three groups', 'There were 2,245 ARRT-reviewed resident hospitalisations and 11,892 usual care resident hospital admissions during 2015-16', 'older RACF residents']","['RACF', 'hospital avoidance program versus usual care']",[],"[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C2718033', 'cui_str': 'Hospital Medical Emergency Team'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0135492,"Age, comorbid health conditions and dementia were predictors of group membership in both ARRT-reviewed RACF residents and usual care RACF residents.","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Testa', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia. Electronic address: luke.testa@mq.edu.au.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Hardy', 'Affiliation': 'Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia; The University of Sydney, Sydney, NSW, 2006, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Jepson', 'Affiliation': 'Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Braithwaite', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Mitchell', 'Affiliation': 'Australian Institute of Health Innovation, Macquarie University, Sydney, NSW, 2109, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104293']
1636,33220574,A spiritual education course to enhance nursing students' spiritual competencies.,"The study aimed to determine the impact of an elective spiritual education course for nursing students on spiritual competencies. A convenience sample of nursing students (N = 92) was recruited from a baccalaureate school of nursing between February and July 2016. The intervention group (n = 45) was comprised of students enrolled in the elective spiritual education course which integrated non-Christian Eastern cultural beliefs; the control group was comprised of students not enrolled in the elective (n = 47). A quasi-experimental design examined pretest, posttest, and follow-up data from students' self-administered questionnaires. The intervention effect of the course was analyzed using generalized estimation equation. The results indicated posttest scores among nursing students in the intervention group were significantly better than the comparison group for spiritual health. Practicum stress and professional commitment were significantly better at follow-up. Spiritual care attitudes, caring behavior, and religious belief were significantly improved from pretest to posttest, and at follow-up for the intervention group compared with the control group. In conclusion, a spiritual education course should be considered as a regular course in the nursing curriculum, which could improve students' spiritual competencies, individual spiritual growth, and the ability to care for patients.",2020,The results indicated posttest scores among nursing students in the intervention group were significantly better than the comparison group for spiritual health.,"['A convenience sample of nursing students (N\xa0=\xa092) was recruited from a baccalaureate school of nursing between February and July 2016', 'nursing students on spiritual competencies']","['elective spiritual education course which integrated non-Christian Eastern cultural beliefs; the control group', 'elective spiritual education']","['Spiritual care attitudes, caring behavior, and religious belief', 'Practicum stress and professional commitment', 'spiritual health']","[{'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0150355', 'cui_str': 'Spiritual support'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035045', 'cui_str': 'Religious Beliefs'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0686997', 'cui_str': 'Spiritual health of patient'}]",,0.0118876,The results indicated posttest scores among nursing students in the intervention group were significantly better than the comparison group for spiritual health.,"[{'ForeName': 'Yi-Chien', 'Initials': 'YC', 'LastName': 'Chiang', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Chang Gung Memorial Hospital at Linkou, Taiwan, ROC; Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC. Electronic address: ycchiang@gw.cgust.edu.tw.'}, {'ForeName': 'Hsiang-Chun', 'Initials': 'HC', 'LastName': 'Lee', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC. Electronic address: cathylee@gw.cgust.edu.tw.'}, {'ForeName': 'Tsung-Lan', 'Initials': 'TL', 'LastName': 'Chu', 'Affiliation': 'Administration Center of Quality Management Department, Chang Gung Medical Foundation, Taiwan, ROC. Electronic address: jec75@cgmh.org.tw.'}, {'ForeName': 'Chin-Yen', 'Initials': 'CY', 'LastName': 'Han', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC. Electronic address: cyhan@gw.cgust.edu.tw.'}, {'ForeName': 'Ya-Chu', 'Initials': 'YC', 'LastName': 'Hsiao', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taiwan, ROC; Department of Nursing, Chang Gung Memorial Hospital at Linkou. Electronic address: yjshiao@gw.cgust.edu.tw.'}]",Nurse education in practice,['10.1016/j.nepr.2020.102907']
1637,33225971,Nasal high flow higher than 60 L/min in patients with acute hypoxemic respiratory failure: a physiological study.,"BACKGROUND
Nasal high flow delivered at flow rates higher than 60 L/min in patients with acute hypoxemic respiratory failure might be associated with improved physiological effects. However, poor comfort might limit feasibility of its clinical use.
METHODS
We performed a prospective randomized cross-over physiological study on 12 ICU patients with acute hypoxemic respiratory failure. Patients underwent three steps at the following gas flow: 0.5 L/kg PBW/min, 1 L/kg PBW/min, and 1.5 L/kg PBW/min in random order for 20 min. Temperature and FiO 2 remained unchanged. Toward the end of each phase, we collected arterial blood gases, lung volumes, and regional distribution of ventilation assessed by electrical impedance tomography (EIT), and comfort.
RESULTS
In five patients, the etiology was pulmonary; infective disease characterized seven patients; median PaO 2 /FiO 2 at enrollment was 213 [IQR 136-232]. The range of flow rate during NHF 1.5 was 75-120 L/min. PaO 2 /FiO 2 increased with flow, albeit non significantly (p = 0.064), PaCO 2 and arterial pH remained stable (p = 0.108 and p = 0.105). Respiratory rate decreased at higher flow rates (p = 0.014). Inhomogeneity of ventilation decreased significantly at higher flows (p = 0.004) and lung volume at end-expiration significantly increased (p = 0.007), but mostly in the non-dependent regions. Comfort was significantly poorer during the step performed at the highest flow (p < 0.001).
CONCLUSIONS
NHF delivered at rates higher than 60 L/min in critically ill patients with acute hypoxemic respiratory failure is associated with reduced respiratory rate, increased lung homogeneity, and additional positive pressure effect, but also with worse comfort.",2020,"Inhomogeneity of ventilation decreased significantly at higher flows (p = 0.004) and lung volume at end-expiration significantly increased (p = 0.007), but mostly in the non-dependent regions.","['12 ICU patients with acute hypoxemic respiratory failure', 'patients with acute hypoxemic respiratory failure']",[],"['Respiratory rate', 'range of flow rate', 'Inhomogeneity of ventilation', 'PaCO 2 and arterial pH', 'collected arterial blood gases, lung volumes, and regional distribution of ventilation assessed by electrical impedance tomography (EIT), and comfort', 'lung volume at end-expiration']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4039867', 'cui_str': 'Acute hypoxemic respiratory failure'}]",[],"[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0428199', 'cui_str': 'pH measurement, arterial'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0231933', 'cui_str': 'Distribution of ventilation'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}]",12.0,0.0636054,"Inhomogeneity of ventilation decreased significantly at higher flows (p = 0.004) and lung volume at end-expiration significantly increased (p = 0.007), but mostly in the non-dependent regions.","[{'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Basile', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Mauri', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy. tommaso.mauri@unimi.it.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Spinelli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Dalla Corte', 'Affiliation': ""Intensive Care Unit, Department of Morphology, Surgery and Experimental Medicine, Sant'Anna University Hospital, Ferrara, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Montanari', 'Affiliation': ""Intensive Care Unit, Department of Morphology, Surgery and Experimental Medicine, Sant'Anna University Hospital, Ferrara, Italy.""}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Marongiu', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Via F. Sforza 35, 20122, Milan, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': ""Intensive Care Unit, Department of Morphology, Surgery and Experimental Medicine, Sant'Anna University Hospital, Ferrara, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Galazzi', 'Affiliation': ""Direction of Healthcare Professions, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Grasselli', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pesenti', 'Affiliation': ""Department of Anesthesia, Critical Care and Emergency, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}]","Critical care (London, England)",['10.1186/s13054-020-03344-0']
1638,33225972,One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma {1}.,"BACKGROUND
Severe perineal trauma sustained during childbirth is a serious complication since it can lead to both short- and long-term consequences for women. Some of the methods used to prevent perineal injuries have been evaluated in clinical trials, but there are still gaps in the evidence. A new clinical practice has been introduced, adopted by more than half of the maternity wards in Sweden with the aim of reducing severe perineal trauma. This procedure involves two midwives assisting the woman during the second stage of labour.
METHODS/DESIGN
In this multicentre randomised controlled trial, 2946 women will be randomised to be assisted by one or two midwives during the second stage of labour. Women age 18-47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward. Five maternity wards comprising 19,500 births/year in different parts of Sweden will participate in this study. The sample size is powered to demonstrate a 50% reduction (from 4.1-2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree). Secondary outcomes will include maternal and neonatal outcomes, women's experiences, midwives' experiences of the intervention, incontinence, and pelvic floor symptoms. The primary analysis is intention to treat. Questionnaires will be sent to the women at 1 month and 1 year after the birth to assess women's experiences, pain, incontinence, pelvic floor symptoms, sexual function, and mental health.
DISCUSSION
It is important for care during labour and birth to be evidence based. There is a strong desire among midwives to reduce the risk of severe perineal trauma. This may lead to new strategies and practices being implemented into practice without scientific evidence. The intervention might have negative side effects or unintended consequences. On the other hand, there is a possibility of the intervention improving care for women. TRIAL REGISTRATION {2A}: ClinicalTrials.gov NCT03770962 . Registered on 10 December 2018.",2020,"The sample size is powered to demonstrate a 50% reduction (from 4.1-2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree).","['midwives assisting the woman during the second stage of labour', '2946 women', 'Women age 18-47, who plan for their first vaginal birth, with a singleton pregnancy in cephalic presentation, will be asked to participate when admitted to the maternity ward']",[],"['severe perineal trauma', 'severe perineal trauma {1', 'pain, incontinence, pelvic floor symptoms, sexual function, and mental health', ""maternal and neonatal outcomes, women's experiences, midwives' experiences of the intervention, incontinence, and pelvic floor symptoms""]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022872', 'cui_str': 'Second stage of labor'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C1720477', 'cui_str': 'When'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2946.0,0.278057,"The sample size is powered to demonstrate a 50% reduction (from 4.1-2.0%) in primary outcome, which is the prevalence of severe perineal trauma (3rd and 4th degree).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Edqvist', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden. malin.edqvist@med.lu.se.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Dahlen', 'Affiliation': 'School of Nursing and Midwifery, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Häggsgård', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tern', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ängeby', 'Affiliation': 'Centre for Clinical Research and Education, Region Värmland, Karlstad, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tegerstedt', 'Affiliation': 'Department of Obstetrics and Gynaecology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Teleman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ajne', 'Affiliation': 'Department of Obstetrics and Gynaecology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rubertsson', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}]",Trials,['10.1186/s13063-020-04837-7']
1639,33221096,Dentoskeletal changes in open bite treatment using spurs and posterior build-ups: A randomized clinical trial.,"INTRODUCTION
This single-center 2-arm parallel randomized clinical trial aimed to compare the dentoskeletal effects of bonded spurs combined with posterior build-ups vs conventional bonded spurs in the treatment of anterior open bite malocclusion in the mixed dentition.
METHODS
Patients aged from 7 to 11 years with anterior open bite, recruited at a university orthodontic clinic, were randomly allocated into 2 groups. The experimental group consisted of patients treated with bonded spurs combined with posterior build-ups. The comparison group comprised patients treated with conventional bonded spurs. Lateral headfilms were obtained at pretreatment and after 12 months of treatment. The primary outcome was the change in the overbite. Randomization was performed using the Web site www.randomization.com. Sequentially numbered opaque and sealed envelopes were used for allocation concealment. Blinding was applicable for outcome assessment only. Intergroup comparisons were performed using t or Mann-Whitney U tests (P <0.05). Mean difference (MD) and 95% confidence interval (CI) were obtained.
RESULTS
The experimental group included 24 patients (17 female, 7 male; mean age, 8.22 ± 1.06 years) and the comparison group comprised 25 patients (14 female, 11 male; mean age, 8.30 ± 0.99 years). Baseline demographic and cephalometric characteristics were similar between groups. After 12 months, all patients showed improvements. Both groups showed similar improvements of the overbite (MD, 0.00 mm; 95% CI, -0.92 to 0.91), similar slight decreases of the gonial (MD, 0.02°; 95% CI, -1.11 to 1.15) and mandibular plane (MD, 0.15°; 95% CI, -0.64 to 0.93) angles, and similar mandibular molar extrusion (MD, 0.14 mm; 95% CI, -0.27 to 0.56). The experimental group showed significantly smaller extrusion of the maxillary first molar than the comparison group (MD, -0.70 mm; 95% CI, -0.92 to -0.49). The other dentoskeletal variables showed similar changes without statistically significant intergroup differences. No serious harm was observed other than plaque accumulation around the spurs.
CONCLUSIONS
Similar overbite increases and dentoskeletal changes were observed in both groups after 12 months of treatment. Although the experimental group showed significantly smaller extrusion of the maxillary molars, no greater counterclockwise rotation of the mandible than the comparison group was observed.
REGISTRATION
This trial was registered at Clinicaltrials.gov (Identifier NCT03702881).
PROTOCOL
The protocol was not published.
FUNDING
This trial was financed in part by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES), Finance Code 001; and by grants: no. 2017/06440-3, no. 2018/05238-9 and no. 2018/24003-2, São Paulo Research Foundation (FAPESP).",2020,"The experimental group showed significantly smaller extrusion of the maxillary first molar than the comparison group (MD, -0.70 mm; 95% CI, -0.92 to -0.49).","['24 patients (17 female, 7 male; mean age, 8.22\xa0±\xa01.06\xa0years) and the comparison group comprised 25 patients (14 female, 11 male; mean age, 8.30\xa0±\xa00.99\xa0years', 'Patients aged from 7 to 11\xa0years with anterior open bite, recruited at a university orthodontic clinic', 'anterior open bite malocclusion in the mixed dentition']","['bonded spurs combined with posterior build-ups', 'bonded spurs combined with posterior build-ups vs conventional bonded spurs', 'conventional bonded spurs']","['Baseline demographic and cephalometric characteristics', 'change in the overbite', 'counterclockwise rotation', 'smaller extrusion of the maxillary molars', 'Dentoskeletal changes', 'Mean difference (MD) and 95% confidence interval (CI', 'dentoskeletal changes', 'Lateral headfilms', 'smaller extrusion of the maxillary first molar']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708781', 'cui_str': '1.06'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517488', 'cui_str': '0.99'}, {'cui': 'C0266060', 'cui_str': 'Anterior open bite'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011444', 'cui_str': 'Mixed dentition'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1305740', 'cui_str': 'Overbite'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}]",,0.208553,"The experimental group showed significantly smaller extrusion of the maxillary first molar than the comparison group (MD, -0.70 mm; 95% CI, -0.92 to -0.49).","[{'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Aliaga-Del Castillo', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, Brazil. Electronic address: a_aliaga@hotmail.com.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Vilanova', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Miranda', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Luis Ernesto', 'Initials': 'LE', 'LastName': 'Arriola-Guillén', 'Affiliation': 'Division of Orthodontics and Division of Oral and Maxillofacial Radiology, School of Dentistry, Universidad Científica del Sur, Lima, Perú.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Garib', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, and Hospital for Rehabilitation of Craniofacial Anomalies, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Janson', 'Affiliation': 'Department of Orthodontics, Bauru Dental School, University of São Paulo, Bauru, Brazil.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2020.06.031']
1640,33221358,Optimal paediatric defibrillation dosage for children. We need a randomized clinical trial!,,2020,,['children'],[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],,0.0980308,,"[{'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Lopez-Herce', 'Affiliation': 'Gregorio Marañón University General Hospital, Pediatric Department, School of Medicine, Complutense University of Madrid, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón de Madrid, Red de Salud Maternoinfantil y del Desarrollo, Madrid, Spain. Electronic address: jesuslopezherce@med.ucm.es.'}, {'ForeName': 'Jimena Del', 'Initials': 'JD', 'LastName': 'Castillo', 'Affiliation': 'Gregorio Marañón University General Hospital, Pediatric Department, School of Medicine, Complutense University of Madrid, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón de Madrid, Red de Salud Maternoinfantil y del Desarrollo, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rodriguez-Nunez', 'Affiliation': 'Gregorio Marañón University General Hospital, Pediatric Department, School of Medicine, Complutense University of Madrid, Instituto de Investigación Sanitaria del Hospital Gregorio Marañón de Madrid, Red de Salud Maternoinfantil y del Desarrollo, Madrid, Spain.'}]",Resuscitation,['10.1016/j.resuscitation.2020.10.044']
1641,33221561,Conventional IVF revisited: Is ICSI better for non-male factor infertility? Randomized controlled double blind study.,"STUDY QUESTION
Is ICSI better than conventional IVF for non-male factor infertility?
SUMMARY ANSWER
IVF should be the choice of assisted reproductive technique in non-male factor infertility cases.
WHAT IS ALREADY KNOWN
Although total fertilization failure is a major concern for patients and professionals, the overall risk/benefit analysis favors conventional IVF in non-male factor infertility cases. However, according to the ESHRE EIM database pertaining to 1997-2012, the use of IVF has been continuously decreasing in favor of ICSI.
STUDY DESIGN, SIZE, DURATION
Randomized controlled double-blind study involving 138 women undergoing ART in a private Center.
PARTICIPANTS/MATERIALS, SETTING, METHODS
All couples with a female partner ≤42 years of age and without severe male factor (total progressive motile sperm with normal morphology >10.000) were included in the study. Exclusion criteria were: history of total fertilization failure, less than 6 cumulus oocyte complexes (COC) available for fertilization, prenatal genetic testing (PGT) cycles, unwillingness to participate and couples undergoing total cryopreservation for any indication. On the day of oocyte pick up, sibling COCs were randomly allocated to fertilization with IVF or denudation followed by ICSI to MII oocytes. The decision to transfer IVF or ICSI embryo(s) depended on embryo quality. Women receiving two embryos were given only IVF or ICSI embryos. Neither the clinician performing the transfer nor the patients were aware of the fertilization method used to generate the embryos transferred. Main outcome parameters were fertilization, clinical pregnancy, implantation and miscarriage rates.
MAIN RESULTS AND THE ROLE OF CHANCE
Demographic variables, ovarian reserve and infertility etiology, duration of stimulation, total gonadotropin consumption, peak estradiol levels were similar for IVF-ET and ICSI-ET groups. Mean number of COCs (18.95 vs 19.24), number of embryos transferred (1,81 vs 1,81), the ratio of good quality embryos/total embryos (56.89 % and 55.97 %), clinical pregnancy rates (63 % vs 49 %), implantation rates (31 % vs 28 %), and abortion rates (12,5 % vs 8,1 %) were also similar. A total of 1306 COCs were allocated for IVF while 1331 COCs were denuded for ICSI. Fertilization rate per inseminated oocyte was significantly higher in ICSI group (56,20 % vs 63,78 %). There were ten cases of total fertilization failure, all in the IVF group. Although overall fertilization rate was higher for ICSI, it was similar in both groups when cases with total fertilization failure were excluded.
LIMITATIONS, REASONS FOR CAUTION
The non-availability of live birth rates is a limitation. Randomization of sibling oocytes, not patients requires careful interpretation of pregnancy and implantation rates.
WIDER IMPLICATIONS OF THE FINDINGS
Lower cost, ease of application and similar clinical outcome makes IVF the choice of fertilization method in non-male factor infertility cases.",2020,"Although overall fertilization rate was higher for ICSI, it was similar in both groups when cases with total fertilization failure were excluded.
","['Exclusion criteria were: history of total fertilization failure, less than 6 cumulus oocyte complexes (COC) available for fertilization, prenatal genetic testing (PGT) cycles, unwillingness to participate and couples undergoing total cryopreservation for any indication', 'A total of 1306 COCs', '138 women undergoing ART in a private Center', 'All couples with a female partner ≤42 years of age and without severe male factor (total progressive motile sperm with normal morphology >10.000) were included in the study']","['conventional IVF', 'ICSI', 'Conventional IVF revisited']","['Fertilization rate per inseminated oocyte', 'embryo quality', 'clinical pregnancy rates', 'Mean number of COCs', 'Demographic variables, ovarian reserve and infertility etiology, duration of stimulation, total gonadotropin consumption, peak estradiol levels', 'abortion rates', 'ratio of good quality embryos/total embryos', 'total fertilization failure', 'number of embryos transferred', 'fertilization, clinical pregnancy, implantation and miscarriage rates', 'overall fertilization rate', 'implantation rates']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0000794', 'cui_str': 'Abortion Rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",138.0,0.437391,"Although overall fertilization rate was higher for ICSI, it was similar in both groups when cases with total fertilization failure were excluded.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Isikoglu', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey. Electronic address: misikoglu@hotmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avci', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kendirci Ceviren', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Aydınuraz', 'Affiliation': 'GELECEK IVF Center, Antalya, Turkey.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ata', 'Affiliation': 'Koç University School of Medicine, Department of Obstetrics and Gynecology, Istanbul, Turkey.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101990']
1642,33221594,Short-term differences in cardiac function following controlled exposure to cookstove air pollution: The subclinical tests on volunteers exposed to smoke (STOVES) study.,"BACKGROUND
Exposure to household air pollution from solid fuel combustion for cooking and heating is an important risk factor for premature death and disability worldwide. Current evidence supports an association of ambient air pollution with cardiovascular disease but is limited for household air pollution and for cardiac function. Controlled exposure studies can complement evidence provided by field studies.
OBJECTIVES
To investigate effects of short-term, controlled exposures to emissions from five cookstoves on measures of cardiac function.
METHODS
Forty-eight healthy adults (46% female; 20-36 years) participated in six, 2-h exposures ('treatments'), including emissions from five cookstoves and a filtered-air control. Target fine particulate matter (PM 2.5 ) exposure-concentrations per treatment were: control, 0 µg/m 3 ; liquefied petroleum gas, 10 µg/m 3 ; gasifier, 35 µg/m 3 ; fan rocket, 100 µg/m 3 ; rocket elbow, 250 µg/m 3 ; and three stone fire, 500 µg/m 3 . Participants were treated in a set (pre-randomized) sequence as groups of 4 to minimize order bias and time-varying confounders. Heart rate variability (HRV) and cardiac repolarization metrics were calculated as 5-min means immediately and at 3 h following treatment, for analysis in linear mixed-effects models comparing cookstove to control.
RESULTS
Short-term differences in SDNN (standard deviation of duration of all NN intervals) and VLF (very-low frequency power) existed for several cookstoves compared to control. While all cookstoves compared to control followed a similar trend for SDNN, the greatest effect was seen immediately following three stone fire (β = -0.13 ms {%}; 95% confidence interval = -0.22, -0.03%), which reversed in direction at 3 h (0.03%; -0.06, 0.13%). VLF results were similar in direction and timing to SDNN; however, other HRV or cardiac repolarization results were not similar to those for SDNN.
DISCUSSION
We observed some evidence of short-term, effects on HRV immediately following cookstove treatments compared to control. Our results suggest that cookstoves with lower PM 2.5 emissions are potentially capable of affecting cardiac function, similar to stoves emitting higher PM 2.5 emissions.",2020,"While all cookstoves compared to control followed a similar trend for SDNN, the greatest effect was seen immediately following three stone fire (β = ","[""Forty-eight healthy adults (46% female; 20-36\xa0years) participated in six, 2-h exposures ('treatments'), including emissions from five cookstoves and a filtered-air control"", 'volunteers exposed to smoke (STOVES) study']",['controlled exposure to cookstove air pollution'],"['cardiac function', 'Heart rate variability (HRV) and cardiac repolarization metrics', 'SDNN (standard deviation of duration of all NN intervals) and VLF', 'HRV or cardiac repolarization results']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",48.0,0.0248694,"While all cookstoves compared to control followed a similar trend for SDNN, the greatest effect was seen immediately following three stone fire (β = ","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cole-Hunter', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA; Centre for Air Pollution, Energy, and Health Research, University of New South Wales, Sydney, NSW, Australia; International Laboratory for Air Quality and Health, Institute of Health and Biomedical Innovation, Queensland University of Technology (QUT), Brisbane, QLD, Australia; Section of Environmental Health, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Radhika', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'Department of Environmental Sciences and Engineering, University of North Carolina, NC, USA; Environmental Public Health Division, United States Environmental Protection Agency, Chapel Hill, NC, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Fedak', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Good', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': ""L'Orange"", 'Affiliation': 'Department of Mechanical Engineering, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Luckasen', 'Affiliation': 'Heart Center of the Rockies, Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehaffy', 'Affiliation': 'Department of Mechanical Engineering, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Walker', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Statistics, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Environmental Public Health Division, United States Environmental Protection Agency, Chapel Hill, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Volckens', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA; Department of Mechanical Engineering, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, CO, USA.'}]",Environment international,['10.1016/j.envint.2020.106254']
1643,33221606,Effectiveness of an Interpersonal Psychotherapy (IPT) Group Depression Treatment for Head Start Mothers: A Cluster-Randomized Controlled Trial.,"BACKGROUND
Maternal depression is known to be a serious problem with higher rates among poor and racial/ethnic minority mothers that can have numerous negative impacts on their children. These mothers have less access to effective care and may be wary of traditional mental health care because of the stigma. The purpose of this study was to test whether an adaptation of an Interpersonal Psychotherapy group for perinatal depression could be effective in reducing depressive symptoms of mothers whose children were enrolled in Head Start.
METHODS
Forty-nine mothers, randomized by site, were recruited into the intervention group, 70 into the control group. They were measured on depressive symptoms, parenting stress, parenting behavior, and parent child interaction at intake, at end of the group, and 6 months following.
RESULTS
The intervention group was lower in depressive symptoms at the end of treatment with a further decrease 6 months post intervention. There was no change in the control group. The intervention group also improved in parenting stress.
LIMITATIONS
The sample size for the intervention group was smaller than desired.
CONCLUSIONS
This study supports the effectiveness of this 12 session IPT group which was highly effective for a population of Head Start mothers. It is a strategy that can be adapted to other settings that serve low income mothers.",2020,The intervention group was lower in depressive symptoms at the end of treatment with a further decrease 6 months post intervention.,"['Head Start Mothers', 'population of Head Start mothers', 'Forty-nine mothers', 'mothers whose children were enrolled in Head Start']","['Interpersonal Psychotherapy (IPT', 'Interpersonal Psychotherapy']","['depressive symptoms', 'parenting stress', 'depressive symptoms, parenting stress, parenting behavior, and parent child interaction at intake']","[{'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.126337,The intervention group was lower in depressive symptoms at the end of treatment with a further decrease 6 months post intervention.,"[{'ForeName': 'Ferol E', 'Initials': 'FE', 'LastName': 'Mennen', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W 34th St, Los Angeles, CA 90089. Electronic address: mennen@usc.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Palmer Molina', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Monro', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Duan', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Stuart', 'Affiliation': 'IPT Institute, Coralville, Iowa.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Sosna', 'Affiliation': ""Children's Institute Inc., Los Angeles, CA.""}]",Journal of affective disorders,['10.1016/j.jad.2020.11.074']
1644,33221618,Radiation dose reduction capabilities of a new C-arm system with optimized hard- and software.,"PURPOSE
To assess the radiation dose reduction capabilities and the image quality of a new C-arm system in comparison to a standard C-arm system.
METHOD
Prospective, randomized, IRB approved two-arm trial design. 49 consecutive patients with primary or secondary liver cancer were treated with transarterial chemoembolization (TACE) on two different angiography units. 28 patients were treated on a conventional angiography unit B, 21 patients on unit A which provides improved hardware and optimized image processing algorithms. Dose area product (DAP) and fluoroscopy time were recorded. DSA image quality of all procedures was assessed on a four-rank-scale by two independent and blinded readers.
RESULTS
Both cohorts showed no significant differences with regard to patient characteristics, tumor burden and fluoroscopy time. The new system resulted in a statistically significant reduction of cumulative DAP of 72% compared to the old platform (median 76 vs. 269 Gy*cm2). Individually, Fluoro-DAP and DSA-DAP decreased by 48% and 77% (p = 0.012 and p < 0.01), respectively. No statistically significant differences in DSA image quality were found between the two imaging platforms.
CONCLUSIONS
The new C-arm system significantly reduced radiation exposure for TACE procedures without increased radiation time or negative impact on DSA image quality. The combination of optimized hardware and software yields the highest radiation dose reduction and is of utmost importance for patients and interventionalists.",2020,The new C-arm system significantly reduced radiation exposure for TACE procedures without increased radiation time or negative impact on DSA image quality.,"['49 consecutive patients with primary or secondary liver cancer', '28 patients']","['conventional angiography unit B, 21 patients on unit A which provides improved hardware and optimized image processing algorithms', 'transarterial chemoembolization (TACE']","['DSA image quality', 'patient characteristics, tumor burden and fluoroscopy time', 'cumulative DAP', 'Dose area product (DAP) and fluoroscopy time', 'Fluoro-DAP and DSA-DAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0442842', 'cui_str': 'Conventional angiography'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0522522', 'cui_str': 'Transarterial approach'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",49.0,0.041164,The new C-arm system significantly reduced radiation exposure for TACE procedures without increased radiation time or negative impact on DSA image quality.,"[{'ForeName': 'Domagoj', 'Initials': 'D', 'LastName': 'Javor', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. Electronic address: domagoj.javor@meduniwien.ac.at.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Moyses', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loewe', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Ruediger E', 'Initials': 'RE', 'LastName': 'Schernthaner', 'Affiliation': 'Division of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109367']
1645,32712805,Correction to: Influence of Postoperative Posture on Macular Slippage after Macula-Off Retinal Detachment: A Randomized Controlled Trial.,The original article can be found online.,2020,The original article can be found online.,['Macular Slippage after Macula-Off Retinal Detachment'],['Postoperative Posture'],[],"[{'cui': 'C0227662', 'cui_str': 'Structure of macula densa'}, {'cui': 'C0035305', 'cui_str': 'Retinal detachment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}]",[],,0.0996259,The original article can be found online.,"[{'ForeName': 'Megir', 'Initials': 'M', 'LastName': 'Schawkat', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Valmaggia', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Hendrik P N', 'Initials': 'HPN', 'LastName': 'Scholl', 'Affiliation': 'Institute of Molecular and Clinical Ophthalmology Basel (IOB), Basel, Switzerland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Harsum', 'Affiliation': 'Epsom and St Helier University Hospitals, NHS Trust, London, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Guber', 'Affiliation': 'Department of Ophthalmology, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Guber', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland. josef.guber@kssg.ch.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00284-4']
1646,32712806,"Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.","INTRODUCTION
Patients with relapsed or refractory multiple myeloma (RRMM) represent an unmet clinical need. Belantamab mafodotin (belamaf; GSK2857916) is a first-in-class antibody-drug conjugate (ADC; or immunoconjugate) that delivers a cytotoxic payload, monomethyl auristatin F (MMAF), to myeloma cells. In the phase II DREAMM-2 study (NCT03525678), single-agent belamaf (2.5 mg/kg) demonstrated clinically meaningful anti-myeloma activity (overall response rate 32%) in patients with heavily pretreated disease. Microcyst-like epithelial changes (MECs) were common, consistent with reports from other MMAF-containing ADCs.
METHODS
Corneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected. A literature review on corneal events reported with other ADCs was performed.
RESULTS
In most patients receiving single-agent belamaf (72%; 68/95), MECs were observed by slit lamp microscopy early in treatment (69% had their first event by dose 4). However, IVCM revealed hyperreflective material. Blurred vision (25%) and dry eye (15%) were commonly reported symptoms. Management of MECs included dose delays (47%)/reductions (25%), with few patients discontinuing due to MECs (1%). The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date. A literature review confirmed that similar MECs were reported with other ADCs; however, event management strategies varied. The pathophysiology of MECs is unclear, though the ADC cytotoxic payload may contribute to on- or off-target effects on corneal epithelial cells.
CONCLUSION
Single-agent belamaf represents a new treatment option for patients with RRMM. As with other ADCs, MECs were observed and additional research is warranted to determine their pathophysiology. A multidisciplinary approach, involving close collaboration between eye care professionals and hematologist/oncologists, is needed to determine appropriate diagnosis and management of these patients.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier, NCT03525678.",2020,"The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date.","['patients with heavily pretreated disease', 'patients with RRMM', 'Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin', 'Corneal examination findings from patients in DREAMM-2 were reviewed, and the clinical descriptions and accompanying images (slit lamp microscopy and in vivo confocal microscopy [IVCM]) of representative events were selected', 'Patients with relapsed or refractory multiple myeloma (RRMM']",[],"['visual acuity', 'Blurred vision', 'clinically meaningful anti-myeloma activity', 'blurred vision', 'Microcyst-like epithelial changes (MECs', 'MECs', 'permanent vision loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4704928', 'cui_str': 'Antibody-Drug Conjugates'}, {'cui': 'C0438105', 'cui_str': 'Examination finding'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0419360', 'cui_str': 'Ocular slit lamp examination'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",[],"[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}]",,0.0423515,"The first event resolved in most patients (grade ≥2 MECs and visual acuity [each 77%], blurred vision [67%], and dry eye [86%]), with no reports of permanent vision loss to date.","[{'ForeName': 'Asim V', 'Initials': 'AV', 'LastName': 'Farooq', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA. afarooq@bsd.uchicago.edu.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Degli Esposti', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Praneetha', 'Initials': 'P', 'LastName': 'Thulasi', 'Affiliation': 'Emory Eye Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Zaugg', 'Affiliation': 'Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ashraf Z', 'Initials': 'AZ', 'LastName': 'Badros', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bennie H', 'Initials': 'BH', 'LastName': 'Jeng', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Opalinska', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'January', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Colby', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00280-8']
1647,32719055,What matters most to patients when choosing treatment for mild-moderate asthma? Results from a discrete choice experiment.,"BACKGROUND
An as-needed combination preventer and reliever regimen was recently introduced as an alternative to conventional daily preventer treatment for mild asthma. In a subgroup analysis of the PRACTICAL study, a pragmatic randomised controlled trial of budesonide-formoterol reliever therapy versus maintenance budesonide plus terbutaline reliever therapy in adults with mild asthma, we recently reported that about two-thirds preferred as-needed combination preventer and reliever therapy. The aim of this study was to determine the relative importance of attributes associated with these two asthma therapies in this subgroup of participants who indicated their preferred treatment in the PRACTICAL study.
METHODS
At their final study visit, a subgroup of participants indicated their preferred treatment and completed a discrete choice experiment using the Potentially All Pairwise RanKings of all possible Alternatives method and 1000minds software. Treatment attributes and their levels were selected from measurable study outcomes, and included: treatment regimen, shortness of breath, steroid dose and likelihood of asthma flare-up.
RESULTS
The final analysis dataset included 288 participants, 64% of whom preferred as-needed combination preventer and reliever. Of the attributes, no shortness of breath and lowest risk of asthma flare-up were ranked highest and second highest, respectively. However, the relative importance of the other two attributes varied by preferred therapy: treatment regimen was ranked higher by participants who preferred as-needed treatment than by participants who preferred maintenance treatment.
CONCLUSIONS
Knowledge of patient preferences for treatment attributes together with regimen characteristics can be used in shared decision-making regarding choice of treatment for patients with mild-moderate asthma.
TRIAL REGISTRATION NUMBER
ACTRN12616000377437.",2020,"However, the relative importance of the other two attributes varied by preferred therapy: treatment regimen was ranked higher by participants who preferred as-needed treatment than by participants who preferred maintenance treatment.
","['288 participants, 64% of whom preferred as-needed combination preventer and reliever', 'adults with mild asthma', 'mild asthma', 'patients with mild-moderate asthma']","['budesonide-formoterol reliever therapy', 'budesonide plus terbutaline reliever therapy']","['shortness of breath, steroid dose and likelihood of asthma flare-up']","[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",288.0,0.0755572,"However, the relative importance of the other two attributes varied by preferred therapy: treatment regimen was ranked higher by participants who preferred as-needed treatment than by participants who preferred maintenance treatment.
","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Baggott', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand christina.baggott@mrinz.ac.nz.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hansen', 'Affiliation': 'Economics, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hancox', 'Affiliation': 'Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Jo Katherine', 'Initials': 'JK', 'LastName': 'Hardy', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Sparks', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Holliday', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weatherall', 'Affiliation': 'Medicine, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Helen K', 'Initials': 'HK', 'LastName': 'Reddel', 'Affiliation': 'Woolcock Institute of Medical Research, University of Sydney, Glebe, New South Wales, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Fingleton', 'Affiliation': 'Asthma Programme, Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-214343']
1648,31821466,Efficacy of Adjunctive Zinc in Improving the Treatment Outcomes in Hospitalized Children with Pneumonia: A Randomized Controlled Trial.,"BACKGROUND
The mortality rate of pneumonia is high, placing a huge burden on developing countries. Healthcare professionals use zinc as an adjunctive treatment for children with pneumonia; however, this contradicts with some published reports. Thus, this study aimed to assess the efficacy of zinc supplementation on the treatment outcomes of pneumonia.
METHODS
A randomized, double-blind, placebo-controlled trial was conducted on hospitalized children with pneumonia. The children randomly received either zinc bis-glycinate (15 mg elemental zinc) or placebo, twice per day. The primary outcome was the resolution time of pneumonia, and the secondary outcomes were the duration of hospitalization and the recovery times of each clinical symptom.
RESULTS
Out of the 91 children, 65 (71.4%) were males. The resolution period of clinical pneumonia was significantly shorter in the zinc group than the placebo group (48 and 72 h, respectively; hazard ratio = 0.585, 95% confidence interval 0.377-0.908). Similarly, the hospitalization period and the resolution period of fever were shorter in the zinc group [96 and 144 h (p = 0.008), and 24 and 42 h (p = 0.002), respectively]. Children receiving zinc needed a median of 28 h to reach the normal level of oxygen saturation compared to 48 h required by children under placebo (p = 0.014).
CONCLUSION
Zinc supplementation enhanced the treatment outcomes of pneumonia, by reducing the resolution period of pneumonia and normalizing oxygen levels and body temperature. The length of hospital stay for children receiving zinc was shorter than those receiving placebo.",2020,"The resolution period of clinical pneumonia was significantly shorter in the zinc group than the placebo group (48 and 72 h, respectively; hazard ratio = 0.585, 95% confidence interval 0.377-0.908).","['children with pneumonia', 'Hospitalized Children with Pneumonia', '91 children, 65 (71.4%) were males', 'hospitalized children with pneumonia']","['Zinc supplementation', 'Adjunctive Zinc', 'zinc supplementation', 'zinc bis-glycinate (15\u2009mg elemental zinc) or placebo', 'placebo']","['resolution period of clinical pneumonia', 'hospitalization period and the resolution period of fever', 'resolution period of pneumonia and normalizing oxygen levels and body temperature', 'duration of hospitalization and the recovery times of each clinical symptom', 'length of hospital stay', 'normal level of oxygen saturation', 'resolution time of pneumonia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0078777', 'cui_str': 'Bis (dibutyldithiocarbamato) zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",91.0,0.583354,"The resolution period of clinical pneumonia was significantly shorter in the zinc group than the placebo group (48 and 72 h, respectively; hazard ratio = 0.585, 95% confidence interval 0.377-0.908).","[{'ForeName': 'Lakkana', 'Initials': 'L', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Preventive Medicine, Srinakharinwirot University, Nakorn Nayok 26120, Thailand.'}, {'ForeName': 'Sanguansak', 'Initials': 'S', 'LastName': 'Rerksuppaphol', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Srinakharinwirot University, Nakorn Nayok 26120, Thailand.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz082']
1649,32720870,Noninvasive Characterization of Tumor Angiogenesis and Oxygenation in Bevacizumab-treated Recurrent Glioblastoma by Using Dynamic Susceptibility MRI: Secondary Analysis of the European Organization for Research and Treatment of Cancer 26101 Trial.,"Background Relevance of antiangiogenic treatment with bevacizumab in patients with glioblastoma is controversial because progression-free survival benefit did not translate into an overall survival (OS) benefit in randomized phase III trials. Purpose To perform longitudinal characterization of intratumoral angiogenesis and oxygenation by using dynamic susceptibility contrast agent-enhanced (DSC) MRI and evaluate its potential for predicting outcome from administration of bevacizumab. Materials and Methods In this secondary analysis of the prospective randomized phase II/III European Organization for Research and Treatment of Cancer 26101 trial conducted between October 2011 and December 2015 in 596 patients with first recurrence of glioblastoma, the subset of patients with availability of anatomic MRI and DSC MRI at baseline and first follow-up was analyzed. Patients were allocated into those administered bevacizumab (hereafter, the BEV group; either bevacizumab monotherapy or bevacizumab with lomustine) and those not administered bevacizumab (hereafter, the non-BEV group with lomustine monotherapy). Contrast-enhanced tumor volume, noncontrast-enhanced T2 fluid-attenuated inversion recovery (FLAIR) signal abnormality volume, Gaussian-normalized relative cerebral blood volume (nrCBV), Gaussian-normalized relative blood flow (nrCBF), and tumor metabolic rate of oxygen (nTMRO 2 ) was quantified. The predictive ability of these imaging parameters was assessed with multivariable Cox regression and formal interaction testing. Results A total of 254 of 596 patients were evaluated (mean age, 57 years ± 11; 155 men; 161 in the BEV group and 93 in non-BEV group). Progression-free survival was longer in the BEV group (3.7 months; 95% confidence interval [CI]: 3.0, 4.2) compared with the non-BEV group (2.5 months; 95% CI: 1.5, 2.9; P = .01), whereas OS was not different ( P = .15). The nrCBV decreased for the BEV group (-16.3%; interquartile range [IQR], -39.5% to 12.0%; P = .01), but not for the non-BEV group (1.2%; IQR, -17.9% to 23.3%; P = .19) between baseline and first follow-up. An identical pattern was observed for both nrCBF and nTMRO 2 values. Contrast-enhanced tumor and noncontrast-enhanced T2 FLAIR signal abnormality volumes decreased for the BEV group (-66% [IQR, -83% to -35%] and -33% [IQR, -71% to -5%], respectively; P < .001 for both), whereas they increased for the non-BEV group (30% [IQR, -17% to 98%], P = .001; and 10% [IQR, -13% to 82%], P = .02, respectively) between baseline and first follow-up. None of the assessed MRI parameters were predictive for OS in the BEV group. Conclusion Bevacizumab treatment decreased tumor volumes, angiogenesis, and oxygenation, thereby reflecting its effectiveness for extending progression-free survival; however, these parameters were not predictive of overall survival (OS), which highlighted the challenges of identifying patients that derive an OS benefit from bevacizumab. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Dillon in this issue.",2020,"Progression-free survival was longer in the BEV group (3.7 months; 95% confidence interval [CI]: 3.0, 4.2) compared with the non-BEV group (2.5 months; 95% CI: 1.5, 2.9; P = .01), whereas OS was not different ( P = .15).","['A total of 254 of 596 patients were evaluated (mean age, 57 years ± 11; 155 men; 161 in the BEV group and 93 in non-BEV group', 'Cancer 26101 trial conducted between October 2011 and December 2015 in 596 patients with first recurrence of glioblastoma, the subset of patients with availability of anatomic MRI and DSC MRI at baseline and first follow-up was analyzed', 'patients with glioblastoma']","['bevacizumab monotherapy or bevacizumab with lomustine', 'bevacizumab (hereafter, the non-BEV group with lomustine monotherapy', 'bevacizumab', 'Bevacizumab']","['Contrast-enhanced tumor volume, noncontrast-enhanced T2 fluid-attenuated inversion recovery (FLAIR) signal abnormality volume, Gaussian-normalized relative cerebral blood volume (nrCBV), Gaussian-normalized relative blood flow (nrCBF), and tumor metabolic rate of oxygen (nTMRO 2 ', 'tumor volumes, angiogenesis, and oxygenation, thereby reflecting its effectiveness for extending progression-free survival', 'Contrast-enhanced tumor and noncontrast-enhanced T2 FLAIR signal abnormality volumes', 'overall survival (OS', 'Progression-free survival', 'nrCBV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0475276', 'cui_str': 'Tumor volume'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0028377', 'cui_str': 'Gaussian Distribution'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C4277714', 'cui_str': 'Cerebral Blood Volume'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",596.0,0.0767009,"Progression-free survival was longer in the BEV group (3.7 months; 95% confidence interval [CI]: 3.0, 4.2) compared with the non-BEV group (2.5 months; 95% CI: 1.5, 2.9; P = .01), whereas OS was not different ( P = .15).","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kickingereder', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Brugnara', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Mikkel Bo', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nowosielski', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Irada', 'Initials': 'I', 'LastName': 'Pflüger', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Schell', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Isensee', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Foltyn', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Neuberger', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kessler', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sahm', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Wick', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Heiland', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Platten', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'von Deimling', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Klaus H', 'Initials': 'KH', 'LastName': 'Maier-Hein', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'From the Department of Neuroradiology, Heidelberg University Hospital, Im Neuenheimer Feld 400, 69120 Heidelberg, Germany (P.K., G.B., I.P., M.S., M.F., U.N., S.H., M.B.); Center of Functionally Integrative Neuroscience and MINDLab, Aarhus University Hospital, Aarhus, Denmark (M.B.H., L.Ø.); Neurology Clinic, Heidelberg University Hospital, Heidelberg, Germany (M.N., T.K., A.W., W.W.); Department of Neurology, Medical University Innsbruck, Innsbruck, Austria (M.N.); Medical Image Computing, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.I., K.H.M.H.); Clinical Cooperation Unit Neurooncology, German Cancer Research Center (DKFZ), Heidelberg, Germany (T.K., W.W.); Department of Neuropathology, Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany (F.S., A.v.D.); Clinical Cooperation Unit Neuropathology, German Cancer Research Center (DKFZ), Heidelberg, Germany (F.S., A.v.D.); Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland (M.W.); Department of Neurology, Medical Faculty Mannheim, MCTN, University of Heidelberg, Mannheim, Germany (M.P.); Pattern Analysis and Learning Group, Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany (K.H.M.H.); Department of Neuroradiology, Aarhus University Hospital, Aarhus, Denmark (L.Ø.); Brain Tumor Center at Erasmus MC Cancer Institute, Rotterdam, the Netherlands (M.J.v.d.B.); and European Organization for Research and Treatment of Cancer (EORTC), Brussels, Belgium (T.G.).'}]",Radiology,['10.1148/radiol.2020200978']
1650,33220397,Optimizing treatment sequencing of chemotherapy for patients with rectal cancer: The KIR randomized phase II trial.,"BACKGROUND
Randomized studies have shown low compliance to adjuvant chemotherapy in rectal cancer patients receiving preoperative chemotherapy and external beam radiation (CT/EBRT) with total mesorectal excision. We hypothesize that giving neoadjuvant CT before local treatment would improve CT compliance.
METHODS
Between 2010-2017, 180 patients were randomized (2:1) to either Arm A (AA) with FOLFOX x6 cycles prior to high dose rate brachytherapy (HDRBT) and surgery plus adjuvant FOLFOX x6 cycles, or Arm B (AB), with neoadjuvant HDRBT with surgery and adjuvant FOLFOX x12 cycles. The primary endpoint was CT compliance to ≥85% of full-dose CT for the first six cycles. Secondary endpoints were ypT0N0, five-year disease free survival (DFS), local control and overall survival (OS).
RESULTS
Patients were randomized to either AA (n = 120, median age (MA) 62 years) or AB (n = 60, MA 63 years). 175/180 patients completed HDRBT as planned (97.2%). In AA, two patients expired during CT; three patients post-randomization received short course EBRT because of progression under CT (n = 2, AA) or personal preference (n = 1, AB). ypT0N0 was 31% in AA and 28% in AB (p = 0.7). CT Compliance was 80% in AA and 53% in AB (p = 0.0002). Acute G3/G4 toxicity was 35.8% in AA and 27.6% in AB (p = 0.23). With a median follow-up of 48.5 months (IQR 33-72), the five-year DFS was 72.3% with AA and 68.3% with AB (p = 0.74), the five-year OS 83.8% for AA and 82.2% for AB (p = 0.53), and the five-year local recurrence was 6.3% for AA and 5.8% for AB (p = 0.71).
CONCLUSION
We confirmed improved compliance to neoadjuvant CT in this study. Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.",2020,"Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.
","['Patients were randomized to either AA (n\u2009=\u2009120, median age (MA) 62 years) or AB (n\u2009=\u200960, MA 63 years', '180 patients', 'Between 2010-2017', 'Patients with Rectal Cancer', 'Study design and participants', 'rectal cancer patients receiving', 'patients with rectal cancer at high risk of systemic recurrence in a randomized multicenter phase II study', 'patients with locally advanced rectal cancer', 'metastatic colorectal']","['preoperative chemotherapy and external beam radiation (CT/EBRT) with total mesorectal excision', 'Chemotherapy', 'oxaliplatin to fluoropyrimidine', 'induction CT', 'adjuvant CT', 'adjuvant chemotherapy', 'FOLFOX x6 cycles prior to high dose rate brachytherapy (HDRBT) and surgery plus adjuvant FOLFOX x6 cycles, or Arm B', 'preoperative pelvic external beam radiotherapy (EBRT) followed by total mesorectal excision (TME); EBRT either consists of long course chemoradiotherapy (LCRT) with 5-FU/ Capecitabine or short course hypofractionated radiotherapy (SCRT)(1-6', '5-FU-based CT', 'fluoropyrimidine-based chemotherapy (CT', 'Oxaliplatin']","['overall survival', 'ypT0N0, five-year disease free survival (DFS), local control and overall survival (OS', 'CT Compliance', 'survival benefit', 'rates of grade 3 and 4 toxicity', 'CT compliance', 'LR rate', 'ypT0N0 rate, local recurrence, and DFS', 'Acute G3/G4 toxicity', 'five-year local recurrence', 'response rates, progression-free survival (PFS), and overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0454270', 'cui_str': 'High dose rate brachytherapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",180.0,0.164095,"Although there is no statistical difference in ypT0N0 rate, local recurrence, and DFS between the two arms, a trend towards favourable oncological outcomes is observed.
","[{'ForeName': 'Aurelie', 'Initials': 'A', 'LastName': 'Garant', 'Affiliation': 'Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Kavan', 'Affiliation': 'Department of Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'André-Guy', 'Initials': 'AG', 'LastName': 'Martin', 'Affiliation': 'Department of Radiation Oncology, Centre hospitalier universitaire de Québec, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Azoulay', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, and Gerald Bronfman Department of Oncology, McGill University, Montreal, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Vendrely', 'Affiliation': 'Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lavoie', 'Affiliation': 'Department of Radiation Oncology, Centre hospitalier universitaire de Québec, Université Laval, Quebec City, Canada.'}, {'ForeName': 'Carol-Ann', 'Initials': 'CA', 'LastName': 'Vasilevsky', 'Affiliation': 'Department of Surgery, Division of Colon and Rectal Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Marylise', 'Initials': 'M', 'LastName': 'Boutros', 'Affiliation': 'Department of Surgery, Division of Colon and Rectal Surgery, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Faria', 'Affiliation': 'Department of Surgery, Division of General Surgery and Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Trung Nghia', 'Initials': 'TN', 'LastName': 'Nguyen', 'Affiliation': 'Department of Hematology, Medical Oncology, Hôpital Charles-LeMoyne, Greenfield Park, Canada.'}, {'ForeName': 'Emery', 'Initials': 'E', 'LastName': 'Ferland', 'Affiliation': 'Department of Hematology, Medical Oncology, Hôpital Pierre-Boucher, Longueuil, Canada.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Des Groseilliers', 'Affiliation': 'Department of Surgery, Hôpital Pierre-Boucher, Longueuil, Canada.'}, {'ForeName': 'Alexis-Simon', 'Initials': 'AS', 'LastName': 'Cloutier', 'Affiliation': 'Department of Surgery, Hôpital Pierre-Boucher, Longueuil, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Diec', 'Affiliation': 'Department of Surgery, Hôpital Pierre-Boucher, Longueuil, Canada.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Drolet', 'Affiliation': ""Department Surgery, Division of Colorectal Surgery, Hôpital Saint-François D'Assise, Quebec City, Canada.""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Richard', 'Affiliation': ""Department of Surgery, Division of Colon and Rectal Surgery, Centre hospitalier de l'Université de Montréal, Montreal, Canada.""}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Batist', 'Affiliation': 'Department of Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Té', 'Initials': 'T', 'LastName': 'Vuong', 'Affiliation': 'Department of Oncology, Division of Radiation Oncology, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Canada. Electronic address: tvuong@jgh.mcgill.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.11.008']
1651,33220488,Zero suicide implementation-effectiveness trial study protocol in outpatient behavioral health using the A-I-M suicide prevention model.,"BACKGROUND
The treatment of suicidal patients often suffers owing to a lack of integrated care and standardized approaches for identifying and reducing risk. The National Strategy for Suicide Prevention endorsed the Zero Suicide (ZS) model, a multi-component, system-wide approach to identify, engage, and treat suicidal patients. The ZS model is a framework for suicide prevention in healthcare systems with the aspirational goal of eliminating suicide in healthcare. While the approach is widely endorsed, it has yet to be evaluated in a systematic manner. This trial evaluates two ZS implementation strategies statewide in specialty mental health clinics.
METHODS/STUDY DESIGN
This trial is the first large-scale implementation of the ZS model in mental health clinics using the Assess, Intervene, and Monitor for Suicide Prevention (A-I-M) clinical model. Using a hybrid effectiveness-implementation type 1 design, we are testing the effectiveness of ZS implementation in 186 mental health clinics in 95 agencies in New York State. Agencies are randomly assigned to either: ""Basic Implementation"" (BI; a large group didactic learning collaboratives) or ""Enhanced Implementation"" (EI; participatory small group learning collaboratives; enhanced consultation for site champions). Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
DISCUSSION
This project has the potential to have a significant public health impact by determining the effectiveness of the ZS model in mental health clinics, a setting where suicide attempts and suicides occur at a higher rate than any other healthcare setting. It will also provide guidance on the implementation level required to achieve uptake and sustainability of ZS.
TRIAL REGISTRATION
N/A.",2020,"Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
","['186 mental health clinics in 95 agencies in New York State', 'suicidal patients', 'specialty mental health clinics']","['Basic Implementation"" (BI; a large group didactic learning collaboratives) or ""Enhanced Implementation"" (EI; participatory small group learning collaboratives', 'ZS implementation']","['suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation']","[{'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",186.0,0.0632626,"Primary outcomes include suicidal behaviors, hospitalizations and Emergency Department visits; implementation outcomes include protocol adoption, protocol fidelity and barriers/facilitators to implementation.
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Stanley', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA. Electronic address: bhs2@cumc.columbia.edu.'}, {'ForeName': 'Christa D', 'Initials': 'CD', 'LastName': 'Labouliere', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Gregory K', 'Initials': 'GK', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, USA.'}, {'ForeName': 'Hanga C', 'Initials': 'HC', 'LastName': 'Galfalvy', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Molly T', 'Initials': 'MT', 'LastName': 'Finnerty', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Prabu', 'Initials': 'P', 'LastName': 'Vasan', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Anni Kramer', 'Initials': 'AK', 'LastName': 'Cummings', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Wainberg', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}, {'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'Carruthers', 'Affiliation': 'New York State Office of Mental Health, USA.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Dixon', 'Affiliation': 'Department of Psychiatry, Columbia University and New York State Psychiatric Institute, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106224']
1652,33221262,Frequency and Impact of Hyponatremia on All-Cause Mortality in Patients With Aortic Stenosis.,"Asymptomatic aortic stenosis (AS) is a frequent condition that may cause hyponatremia due to neurohumoral activation. We examined if hyponatremia heralds poor prognosis in patients with asymptomatic AS, and whether AS in itself is associated with increased risk of hyponatremia. The study question was investigated in 1,677 individuals that had and annual plasma sodium measurements in the SEAS (Simvastatin and Ezetimibe in AS) trial; 1,873 asymptomatic patients with mild-moderate AS (maximal transaortic velocity 2.5 to 4.0 m/s) randomized to simvastatin/ezetimibe combination versus placebo. All-cause mortality was the primary endpoint and incident hyponatremia (P-Na + <137 mmol/L) a secondary outcome. At baseline, 4% (n = 67) had hyponatremia. After a median follow-up of 4.3 (interquartile range 4.1 to 4.6) years, 140 (9%) of those with initial normonatremia had developed hyponatremia, and 174 (10%) had died. In multiple regression Cox models, both baseline hyponatremia (hazard ratio [HR] 2.1, [95% confidence interval 1.1 to 3.8]) and incident hyponatremia (HR 1.9, [95% confidence interval 1.0 to 3.4], both p ≤ .03) was associated with higher all-cause mortality as compared with normonatremia. This association persisted after adjustment for diuretics as a time-varying covariate. Higher N-terminal pro b-type natriuretic peptide levels and lower sodium levels at baseline was associated with higher risk of incident hyponatremia. Conversely, assignment to simvastatin/ezetimibe protected against incident hyponatremia. In conclusion, both prevalent and incident hyponatremia associate with increased mortality in patients with AS. The prevalence of hyponatremia is around 4% and the incidence about 2% per year, which is comparable to that of older adults without AS.",2020,"In multiple regression Cox models, both baseline hyponatremia (HR 2.1, [95% confidence interval 1.1-3.8]) and incident hyponatremia (HR 1.9, [95% confidence interval 1.0-3.4], both p≤.03) was associated with higher all-cause mortality as compared to normonatremia.","['in Aortic Stenosis) trial; 1,873 asymptomatic patients with mild-moderate AS (maximal transaortic velocity 2.5-4.0 m/s) randomized to', '1,677 individuals that had and annual plasma sodium measurements in the', 'Asymptomatic aortic stenosis (AS', 'Patients with Aortic Stenosis', 'patients with asymptomatic AS', 'patients with AS']","['SEAS (Simvastatin and Ezetimibe', 'simvastatin/ezetimibe combination vs. placebo', 'simvastatin/ezetimibe']","['died', 'baseline hyponatremia', 'incident hyponatremia', 'prevalence of hyponatremia', 'hyponatremia']","[{'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0442339', 'cui_str': 'Transaortic approach'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1272109', 'cui_str': 'Plasma sodium measurement'}]","[{'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C1532737', 'cui_str': 'simvastatin and ezetimibe'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",1873.0,0.238044,"In multiple regression Cox models, both baseline hyponatremia (HR 2.1, [95% confidence interval 1.1-3.8]) and incident hyponatremia (HR 1.9, [95% confidence interval 1.0-3.4], both p≤.03) was associated with higher all-cause mortality as compared to normonatremia.","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Ramberg', 'Affiliation': 'Department of Medicine, Nykoebing Falster Hospital, Nykoebing Falster, Denmark. Electronic address: eram12@live.dk.'}, {'ForeName': 'Anders M', 'Initials': 'AM', 'LastName': 'Greve', 'Affiliation': 'Department of Biochemistry, Herlev and Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ronan M G', 'Initials': 'RMG', 'LastName': 'Berg', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Physiology, Nuclear Medicine & PET and Centre for Physical Activity Research, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Steen Bendix', 'Initials': 'SB', 'LastName': 'Haugaard', 'Affiliation': 'Department Endocrinology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Willenheimer', 'Affiliation': 'Heart Health Group, Malmö, Sweden.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Olsen', 'Affiliation': 'Department of Medicine, Holbæk Hospital, Holbæk, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Wachtell', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Olav W', 'Initials': 'OW', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Institute of Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.11.015']
1653,33221559,Prophylactic use of tranexamic acid for decreasing the blood loss in elective cesarean section: A placebo-controlled randomized clinical trial.,"INTRODUCTION
Tranexamic acid is used as a known treatment of post-partum hemorrhage both in natural vaginal deliveries and cesarean sections, but its use in elective cesarean as a prophylactic measure to decrease the blood loss is not so common.
OBJECTIVE
This clinical trial evaluates the efficacy and safety of tranexamic acid in decreasing the bleeding in women undergoing elective cesarean section.
METHOD
200 term singleton pregnant women who were scheduled for elective cesarean section were randomized to 2 groups and received a bolus of 1 gm tranexamic acid if body weight was <90 kg and 1.5 g if body weight was >90 kg diluted in 15 ml of 5% dextrose intravenously, or 5 ml of distilled water in 15 ml of 5% dextrose as placebo (before skin incision). Intra-operative and post-operative blood loss and hemoglobin levels were compared.
RESULTS
Tranexamic acid decreased the mean blood loss by 25.3 % in our studied women. Mean volume of intra-operative blood loss was 391.1 (±67.4) ml in tranexamic acid group and 523.8 (±153.4) ml in control group which was statistically significant lesser with a 132.7 ml difference. Rate of >1000 ml and >500 ml bleeding and need to blood transfusion were also statistically significant lower in tranexamic acid group., mean hemoglobin level was statistically significant lower in placebo group than tranexamic acid group (11.77 ± 0.50 versus 11.31 ± 0.56) 6 h after cesarean section. No adverse reaction was documented.
CONCLUSION
Prophylactic use of intravenous tranexamic acid decreases the blood loss safely in women undergoing elective cesarean section.",2020,", mean hemoglobin level was statistically significant lower in placebo group than tranexamic acid group (11.77 ± 0.50 versus 11.31 ± 0.56) 6 h after cesarean section.","['200 term singleton pregnant women who were scheduled for elective cesarean section', 'women undergoing elective cesarean section', 'elective cesarean section']","['tranexamic acid if body weight was <90\u2009kg and 1.5\u2009g if body weight was >90\u2009kg diluted in 15\u2009ml of 5% dextrose intravenously, or 5\u2009ml of distilled water in 15\u2009ml of 5% dextrose as placebo', 'tranexamic acid', 'placebo', 'Tranexamic acid']","['ml bleeding and need to blood transfusion', 'blood loss safely', 'Intra-operative and post-operative blood loss and hemoglobin levels', 'mean hemoglobin level', 'Mean volume of intra-operative blood loss', 'adverse reaction', 'mean blood loss', 'blood loss']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0985452', 'cui_str': 'Glucose 50 MG/ML'}, {'cui': 'C0790233', 'cui_str': 'Distilled water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",200.0,0.335122,", mean hemoglobin level was statistically significant lower in placebo group than tranexamic acid group (11.77 ± 0.50 versus 11.31 ± 0.56) 6 h after cesarean section.","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Naeiji', 'Affiliation': 'Preventive Gynecology Research Center (PGRC); Department of Gynecology and Obstetrics, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran. Electronic address: Zahranaeiji98@yahoo.com.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Delshadiyan', 'Affiliation': 'Gynecology and Obstetrics Resident, Shahid Beheshti University of Medical Science (SBUMS), Iran.'}, {'ForeName': 'Sorayya', 'Initials': 'S', 'LastName': 'Saleh', 'Affiliation': 'Department of Gynecology and Obstetrics, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran. Electronic address: soraya_saleh2000@yahoo.co.uk.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Moridi', 'Affiliation': 'Department of Gynecology and Obstetrics, Shahid Beheshti University of Medical Science (SBUMS), Tehran, Iran. Electronic address: Moridi59@gmail.com.'}, {'ForeName': 'Nayereh', 'Initials': 'N', 'LastName': 'Rahmati', 'Affiliation': 'Gynecology and Obstetrics Fellow, Shahid Beheshti University of Medical Science (SBUMS), Iran. Electronic address: N136054@yahoo.com.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Fathi', 'Affiliation': 'Iran University of Medical Sciences (IUMS), Iran. Electronic address: marziehfathi@yahoo.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101973']
1654,33221705,Placental growth factor measurements in the assessment of women with suspected Preeclampsia: A stratified analysis of the PARROT trial.,"OBJECTIVE
Placental growth factor testing decreases time to recognition of preeclampsia and may reduce severe maternal adverse outcomes. This analysis aims to describe the clinical phenotype of women by PlGF concentration, and to determine the mechanism(s) underpinning the reduction in severe maternal adverse outcomes in the PARROT trial, in order to inform how PlGF testing may be optimally used within clinical management algorithms.
STUDY DESIGN
This was a planned secondary analysis from the PARROT trial that compared revealed PlGF testing and management guidance with usual care in the assessment of women with suspected preterm preeclampsia.
MAIN OUTCOME MEASURES
Maternal and perinatal outcomes following stratification of women by trial group, and measured PlGF concentration.
RESULTS
1006 women were included. PlGF < 100 pg/ml identified women with more marked hypertension, increased adverse maternal outcomes and preterm delivery rates, and higher rates of small for gestational age infants. There was a reduction in adverse maternal outcomes in women whose results were revealed when PlGF levels were 12-100 pg/ml compared to usual care (3.8% vs 6.9%; aOR 0.15(95% CI 0.03-0.92). There was no significant difference in gestation at delivery between concealed or revealed groups in any PlGF categories.
CONCLUSION
Low PlGF concentrations are associated with severe preeclampsia. The reduction in severe adverse maternal outcomes may be mediated through quicker diagnosis and intensive surveillance, as recommended by the management algorithm for those at increased risk. PlGF is particularly beneficial in those who test 12-100 pg/ml, as these may be women with silent multi-organ disease who otherwise may go undetected.",2020,There was a reduction in adverse maternal outcomes in women whose results were revealed when PlGF levels were 12-100 pg/ml compared to usual care (3.8% vs 6.9%; aOR 0.15(95% CI 0.03-0.92).,"['women with suspected preterm preeclampsia', 'women with suspected Preeclampsia', '1006 women were included', '\xa0100']",['PlGF'],"['adverse maternal outcomes', 'gestation at delivery', 'PlGF levels', 'Placental growth factor measurements', 'adverse maternal outcomes and preterm delivery rates', 'severe adverse maternal outcomes', 'PlGF concentration']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C1504871', 'cui_str': 'PGF protein, human'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1504871', 'cui_str': 'PGF protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0138514', 'cui_str': 'Placenta Growth Factor'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",1006.0,0.314511,There was a reduction in adverse maternal outcomes in women whose results were revealed when PlGF levels were 12-100 pg/ml compared to usual care (3.8% vs 6.9%; aOR 0.15(95% CI 0.03-0.92).,"[{'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Duhig', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London (KED, PTS, AHS, LCC), United Kingdom. Electronic address: Kate.duhig@kcl.ac.uk.""}, {'ForeName': 'Jenny E', 'Initials': 'JE', 'LastName': 'Myers', 'Affiliation': 'The Division of Developmental Biology and Medicine, University of Manchester, United Kingdom. Electronic address: Jenny.myers@manchester.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Neonatal Medicine, School of Public Health, Faculty of Medicine, Chelsea and Westminster Campus, Imperial College London, United Kingdom. Electronic address: Christopher.gale@imperial.ac.uk.'}, {'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Girling', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, United Kingdom. Electronic address: Joanna.girling@chelwest.nhs.uk.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Harding', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, United Kingdom. Electronic address: Kate.harding@gstt.nhs.uk.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sharp', 'Affiliation': ""University of Liverpool and Liverpool Women's Hospital, members of Liverpool Health Partners, United Kingdom. Electronic address: A.sharp@liverpool.ac.uk.""}, {'ForeName': 'Nigel A B', 'Initials': 'NAB', 'LastName': 'Simpson', 'Affiliation': ""Department of Women's and Children's Health, Faculty of Medicine and Health, University of Leeds, United Kingdom. Electronic address: n.a.b.simpson@leeds.ac.uk.""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Tuffnell', 'Affiliation': 'Bradford Institute for Health Research, United Kingdom. Electronic address: Derek.Tuffnell@bthft.nhs.uk.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London (KED, PTS, AHS, LCC), United Kingdom; The Division of Developmental Biology and Medicine, University of Manchester, United Kingdom; Neonatal Medicine, School of Public Health, Faculty of Medicine, Chelsea and Westminster Campus, Imperial College London, United Kingdom. Electronic address: paul.seed@kcl.ac.uk.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London (KED, PTS, AHS, LCC), United Kingdom; The Division of Developmental Biology and Medicine, University of Manchester, United Kingdom; Neonatal Medicine, School of Public Health, Faculty of Medicine, Chelsea and Westminster Campus, Imperial College London, United Kingdom. Electronic address: Andrew.shennan@kcl.ac.uk.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London (KED, PTS, AHS, LCC), United Kingdom; The Division of Developmental Biology and Medicine, University of Manchester, United Kingdom; Neonatal Medicine, School of Public Health, Faculty of Medicine, Chelsea and Westminster Campus, Imperial College London, United Kingdom. Electronic address: lucy.chappell@kcl.ac.uk.""}]",Pregnancy hypertension,['10.1016/j.preghy.2020.10.005']
1655,33221715,Efficacy and neurophysiological predictors of treatment response of adjunct bifrontal transcranial direct current stimulation (tDCS) in treating unipolar and bipolar depression.,"BACKGROUND
Although add-on transcranial direct current stimulation (tDCS) is a promising intervention for treating unipolar (UD) and bipolar depression (BD), its moderate antidepressant efficacy urges research into biomarkers for predicting therapeutic response and achieving highly targeted applications.
METHODS
This open-label trial enrolled UD (N=58) and BD (N=22) patients who had failed 1 or more trials of adequate pharmacologic interventions (ClinicalTrials.gov ID: NCT03287037). Bifrontal tDCS (anode/cathode: F3/F4) was applied using a 2 mA current for 20 min, twice daily, for 5 consecutive weekdays. Depression was measured with Hamilton Depression Rating Scale-17 (HAMD) at baseline, after 10-session stimulation, 1- and 4-week follow-ups. Heart rate (HR) and heart rate variability (HRV) was measured at baseline, during the initial 5 min of the 1 st session, after 10-session stimulation, 1- and 4-week follow-ups. Cognitive performance and other outcomes were also assessed.
RESULTS
Bifrontal tDCS rapidly and equally improved depression in both groups. The effects persisted until the end of the trial. Both groups had similar improvements in cognitive performance, anxiety, and psychosocial functioning. Compared with baseline, increased vagally-mediated HRV was observed one month after tDCS for both groups. A positive correlation was found between HR deceleration within the 1 st session and treatment response after 10-session tDCS only among UD patients, explaining 20% of the variance.
CONCLUSION
tDCS as an adjunct therapy is effective for both UD and BD. Data suggest that the greater the increase in parasympathetic signaling during the 1 st session, the better the clinical response after 10-session tDCS for UD patients.",2020,"A positive correlation was found between HR deceleration within the 1 st session and treatment response after 10-session tDCS only among UD patients, explaining 20% of the variance.
",['N=22) patients who had failed 1 or more trials of adequate pharmacologic interventions (ClinicalTrials.gov ID: NCT03287037'],"['adjunct bifrontal transcranial direct current stimulation (tDCS', 'transcranial direct current stimulation (tDCS', 'tDCS', 'BD']","['cognitive performance, anxiety, and psychosocial functioning', 'HR deceleration', 'Hamilton Depression Rating Scale-17 (HAMD', 'Heart rate (HR) and heart rate variability (HRV', 'Cognitive performance', 'Depression', 'parasympathetic signaling', 'depression', 'vagally-mediated HRV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",,0.0337527,"A positive correlation was found between HR deceleration within the 1 st session and treatment response after 10-session tDCS only among UD patients, explaining 20% of the variance.
","[{'ForeName': 'Yen-Yue', 'Initials': 'YY', 'LastName': 'Lin', 'Affiliation': 'Department of Emergency Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Emergency Medicine, Taoyuan Armed Forces General Hospital, Taoyuan, Taiwan; Department of Life Sciences, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Chuan-Chia', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Cathy Chia-Yu', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Life Sciences, National Central University, Taoyuan, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Kao', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan; Department of Psychiatry, Tri-Service General Hospital Songshan Branch, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hsin-An', 'Initials': 'HA', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. Electronic address: chang.ha@mail.ndmctsgh.edu.tw.'}]",Journal of affective disorders,['10.1016/j.jad.2020.11.030']
1656,33221776,Analgesia for postoperative myomectomy pain: A comparison of ultrasound-guided transversus abdominis plane block and wound infiltration.,"Background
Acute postoperative pain after myomectomy can impair patient function. Like all other postoperative pain, it is a challenge requiring solution, particularly in developing countries. Ultrasound-guided transversus abdominis plane (TAP) block and wound infiltration (WI) are both known to be effective in managing postoperative pain. It is not certain if transversus abdominis plain block would be superior to wound infiltration. Aims: It was hypothesized that the TAP block has similar analgesic effectiveness to wound infiltration.
Subjects and Methods
This study was a randomized controlled trial involving, seventy-four (74) patients scheduled for myomectomy at the University of Benin Teaching Hospital Benin City, Nigeria under the subarachnoid block, which were randomized into TAP and WI group preoperatively. The ultrasound-guided bilateral TAP block group and wound infiltration group (subfascial and subcutaneous infiltration) each used 40 mL of 0.25% of plain bupivacaine to achieve postoperative analgesia. The time to first analgesic request, numerical pain rating scale (NRS) score at rest, and movement were assessed. Data were analyzed using SPSS version 16 (Chicago Il, USA).
Results
The time to first analgesic request was significantly delayed in the TAP block group compared to the wound infiltration group [240 (131, 375) min vs 170 (128, 187) minutes. P = 0.006]. The proportions of patients with NRS score ≤3 at the time of first analgesic requests were significantly more in the TAP block group (P < 0.001). The analgesic consumed by the TAP block group was significantly low compared to the WI group. There were no incidences of complications due to TAP block or wound infiltration.
Conclusion
TAP block provided a longer duration of analgesia and a clinically superior quality of analgesia to wound infiltration.",2020,"There were no incidences of complications due to TAP block or wound infiltration.
","['postoperative myomectomy pain', 'seventy-four (74) patients scheduled for myomectomy at the University of Benin Teaching Hospital Benin City, Nigeria under the subarachnoid block', 'Subjects and Methods']","['TAP', 'TAP block', 'Ultrasound-guided transversus abdominis plane', 'ultrasound-guided bilateral TAP block group and wound infiltration group (subfascial and subcutaneous infiltration) each used 40 mL of 0.25% of plain bupivacaine', 'ultrasound-guided transversus abdominis plane block and wound infiltration', 'Analgesia']","['duration of analgesia', 'TAP) block and wound infiltration (WI', 'complications due to TAP block or wound infiltration', 'time to first analgesic request', 'time to first analgesic request, numerical pain rating scale (NRS) score at rest, and movement', 'time of first analgesic requests']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0580529', 'cui_str': 'Subfascial'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",,0.0544088,"There were no incidences of complications due to TAP block or wound infiltration.
","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Osaheni', 'Affiliation': 'Department of Anaesthesiology, University of Benin Teaching Hospital Benin City, Edo State, Nigeria.'}, {'ForeName': 'H O', 'Initials': 'HO', 'LastName': 'Idehen', 'Affiliation': 'Department of Anaesthesiology, University of Benin Teaching Hospital Benin City, Edo State, Nigeria.'}, {'ForeName': 'C O', 'Initials': 'CO', 'LastName': 'Imarengiaye', 'Affiliation': 'Department of Anaesthesiology, University of Benin Teaching Hospital Benin City, Edo State, Nigeria.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_162_19']
1657,33222584,Spironolactone Use and Improved Outcomes in Patients With Heart Failure With Preserved Ejection Fraction With Resistant Hypertension.,"Background Resistant hypertension is a salt-retaining condition possibly attributable to inappropriate aldosterone secretion. Methods and Results This study was a secondary analysis of the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial. Patients with heart failure with preserved ejection fraction (HFpEF) with (n=1004) and without (n=2437) resistant hypertension were included. Resistant hypertension was defined as systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥80 mm Hg in a patient with hypertension, despite the concurrent use of a renin-angiotensin system blocker (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker), a calcium channel blocker, and a diuretic; or as those patients using ≥4 classes of antihypertensive medication. The primary outcome was a composite of cardiovascular death, aborted cardiac arrest, or heart failure hospitalization. We analyzed hazard ratios (HRs) for outcomes with 95% CIs in the spironolactone group and compared them with the placebo group using Cox proportional hazard models. The risk of primary outcome events in patients with HFpEF with resistant hypertension was significantly lower in the spironolactone group than in the placebo group (HR, 0.70; 95% CI, 0.53-0.91; P =0.009), whereas the risk of primary outcome events in patients with HFpEF without resistant hypertension was not significantly different between the 2 groups (HR, 1.00; 95% CI, 0.83-1.20; P =0.97). There was a significant interaction between spironolactone use and resistant hypertension ( P =0.03). Similar associations were also observed in patients with HFpEF from the Americas (United States, Canada, Brazil, and Argentina) only. Conclusions Spironolactone may be an effective add-on medication for patients with HFpEF with resistant hypertension taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, calcium channel blockers, and diuretics.",2020,"The risk of primary outcome events in patients with HFpEF with resistant hypertension was significantly lower in the spironolactone group than in the placebo group (HR, 0.70; 95% CI, 0.53-0.91; P =0.009), whereas the risk of primary outcome events in patients with HFpEF without resistant hypertension was not significantly different between the 2 groups (HR, 1.00; 95% CI, 0.83-1.20; P =0.97).","['Patients With Heart Failure With Preserved Ejection Fraction With Resistant Hypertension', 'Patients with heart failure with preserved ejection fraction (HFpEF) with (n=1004) and without (n=2437) resistant hypertension were included', 'patients with HFpEF with resistant hypertension taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, calcium channel blockers, and diuretics']","['placebo', 'spironolactone', 'renin-angiotensin system blocker (angiotensin-converting enzyme inhibitor/angiotensin receptor blocker', 'Spironolactone', 'TOPCAT']","['systolic blood pressure ≥130\xa0mm', 'patients with HFpEF with resistant hypertension', 'composite of cardiovascular death, aborted cardiac arrest, or heart failure hospitalization', 'Hg and/or diastolic blood pressure ≥80\xa0mm', 'HFpEF without resistant hypertension', 'hazard ratios (HRs', 'Resistant hypertension', 'resistant hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C4318470', 'cui_str': 'Aborted'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0999539,"The risk of primary outcome events in patients with HFpEF with resistant hypertension was significantly lower in the spironolactone group than in the placebo group (HR, 0.70; 95% CI, 0.53-0.91; P =0.009), whereas the risk of primary outcome events in patients with HFpEF without resistant hypertension was not significantly different between the 2 groups (HR, 1.00; 95% CI, 0.83-1.20; P =0.97).","[{'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Tsujimoto', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism Center Hospital National Center for Global Health and Medicine Tokyo Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kajio', 'Affiliation': 'Department of Diabetes, Endocrinology, and Metabolism Center Hospital National Center for Global Health and Medicine Tokyo Japan.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.018827']
1658,33223425,Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases.,"BACKGROUND
A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie's disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial.
AIM
To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854).
METHODS
A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD.
OUTCOMES
The primary outcomes are safety, penile length, penile curvature, Peyronie's Disease Questionnaire, International Index of Erectile Function, and satisfaction.
RESULTS
6-month (n = 64) and 9-month (n = 63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7-2.0 cm) and curvature improvements (18-20%). PTT-to-PTT men also achieved additional length (0.6-0.8 cm) without further curvature improvements. An as-treated analysis of PTT use ≥15 minute/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18-21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie's Disease Questionnaire were significantly improved (except orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0-2.2 cm), and 61% had curve improvements (16.8-21.4° [32.8-35.8%]). RestoreX was preferred 3-4:1 over all other PD treatments, and 100% preferred it over other PTT devices.
CLINICAL IMPLICATIONS
Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs.
STRENGTHS & LIMITATIONS
Strengths include largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3-9 hours) treatment arm.
CONCLUSION
PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD. Joseph J, Ziegelmann M, Alom M, et al. Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. J Sex Med 2020;17:2462-2471.",2020,All sexual function domains of the International Index of Erectile Function and Peyronie's Disease Questionnaire were significantly improved (except orgasmic domain).,"[""Men With Peyronie's Disease"", ""men with Peyronie's disease (PD"", 'managing men with PD', '2017 to 2019 in 110 all-comer men with PD']","['RestoreX Penile Traction Therapy', 'RestoreX traction therapy', 'RestoreX PTT', 'RestoreX', 'RestoreX (PTT) or no therapy (control']","['adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD', 'curvature improvements', 'length, curve, and subjective and objective measures of sexual function', 'temporary erythema and discomfort', 'length gains', ""safety, penile length, penile curvature, Peyronie's Disease Questionnaire, International Index of Erectile Function, and satisfaction"", ""International Index of Erectile Function and Peyronie's Disease Questionnaire""]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030848', 'cui_str': 'Induratio penis plastica'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2938970', 'cui_str': 'Penile curvature'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030848', 'cui_str': 'Induratio penis plastica'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.075799,All sexual function domains of the International Index of Erectile Function and Peyronie's Disease Questionnaire were significantly improved (except orgasmic domain).,"[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ziegelmann', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Manaf', 'Initials': 'M', 'LastName': 'Alom', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Savage', 'Affiliation': ""Mayo Clinic, Rochester, MN, USA; Male Fertility and Peyronie's Clinic, Orem, UT, USA.""}, {'ForeName': 'Tobias S', 'Initials': 'TS', 'LastName': 'Köhler', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Trost', 'Affiliation': ""Mayo Clinic, Rochester, MN, USA; Male Fertility and Peyronie's Clinic, Orem, UT, USA. Electronic address: email@mfp.clinic.""}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.10.003']
1659,33231925,Assessment of COVID-19 Treatment containing both Hydroxychloroquine and Azithromycin: A natural clinical trial.,"The goal of this study was to assess the clinical effectiveness and safety profile of the COVID-19 treatment protocol (containing both hydroxychloroquine (HCQ) and azithromycin) in an Iraqi specialised hospital.
METHODS
This prospective study used a pre- and post-intervention design without a comparison group. The intervention was routine Ministry of Health (MOH) approved the management of COVID-19 for all patients. The study was conducted in a public healthcare setting in Baghdad, Iraq from March 1st to May 25, 2020. The study outcome measures included the changes in clinical and biochemical parameters during the hospitalisation period. Paired t-test and Chi-square test were used to compare the measures of vital signs, lab tests and symptoms before and after treatment.
RESULTS
The study included 161 patients who were admitted with positive RT-PCR and clinical symptoms of COVID-19. In terms of severity, 53 (32.9%) patients had amild condition, 47 (29.2%) had moderate condition, 35 (21.7%) had severe condition and 26 (16.1%) had critical condition. Most patients (84.5%) recovered and were discharged without symptoms after testing negative with RT-PCR, while 11 (6.8%) patients died during the study period. The signs and symptoms of COVID-19 were reduced significantly in response to a therapy regimen containing HCQ and azithromycin. The most common reported side effects were stomach pain, hypoglycemia, dizziness, itching, skin rash, QT prolongation, arrhythmia, and conjunctivitis.
CONCLUSIONS
This natural trial showed that the COVID-19 regimen containing both HCQ and azithromycin can be helpful to promote the recovery of most patients and reduced their signs and symptoms significantly. It also shows some manageable side effects mostly those related to heart rhythm. In the absence of FDA-approved medications to treat COVID-19, the repurposing of HCQ and azithromycin to control the disease signs and symptoms can be useful.",2020,The signs and symptoms of COVID-19 were reduced significantly in response to therapy regimen containing HCQ and azithromycin.,"['161 patients who were admitted with positive RT-PCR and clinical symptoms of COVID-19', 'public healthcare setting in Baghdad, Iraq from March 1st to May 25, 2020']","['COVID-19 treatment protocol (containing both hydroxychloroquine (HCQ) and azithromycin', 'azithromycin', 'Hydroxychloroquine and Azithromycin', 'HCQ and azithromycin']","['stomach pain, hypoglycemia, dizziness, itching, skin rash, QT prolongation, arrhythmia, and conjunctivitis', 'clinical effectiveness and safety profile', 'severe condition', 'signs and symptoms of COVID-19']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205435', 'cui_str': 'First'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",161.0,0.0382432,The signs and symptoms of COVID-19 were reduced significantly in response to therapy regimen containing HCQ and azithromycin.,"[{'ForeName': 'Hassan M', 'Initials': 'HM', 'LastName': 'Abbas', 'Affiliation': 'Headquarter, Ministry of Health, Baghdad, Iraq.'}, {'ForeName': 'Ali Azeez', 'Initials': 'AA', 'LastName': 'Al-Jumaili', 'Affiliation': 'College of Pharmacy, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Kawthar F', 'Initials': 'KF', 'LastName': 'Nassir', 'Affiliation': 'Therapeutic Drug Monitoring Center, Baghdad Teaching Hospital, Medical City Complex, Baghdad, Iraq.'}, {'ForeName': 'Muhammed Waheeb', 'Initials': 'MW', 'LastName': 'Al-Obaidy', 'Affiliation': 'University of Baghdad College of Medicine, Baghdad, Iraq.'}, {'ForeName': 'Adnan Mohammed', 'Initials': 'AM', 'LastName': 'Al Jubouri', 'Affiliation': 'University of Baghdad College of Medicine, Baghdad, Iraq.'}, {'ForeName': 'Basim Dhawi', 'Initials': 'BD', 'LastName': 'Dakhil', 'Affiliation': 'Critical Care Unit, Bagdad Teaching Hospital, Medical City Complex, Internal Medicine Department in Al-Shifa center for the treatment of COVID-19, Baghdad, Iraq.'}, {'ForeName': 'Mohammed Mahir', 'Initials': 'MM', 'LastName': 'Abdulelah', 'Affiliation': 'Intensive Care Unit, Bagdad Teaching Hospital, Medical City Complex, Baghdad, Iraq.'}, {'ForeName': 'Qutaiba Ahmed', 'Initials': 'QA', 'LastName': 'Al Khames', 'Affiliation': 'Faculty of Pharmacy, Philadelphia University, Amman, Jordan.'}]",International journal of clinical practice,['10.1111/ijcp.13856']
1660,33227335,Short- and long-term functional results following drug-coated balloons versus drug- eluting stents in small coronary vessels: The RESTORE quantitative flow ratio study.,"Background Immediate and long-term functional outcomes after percutaneous treatment of small vessel disease (SVD) with drug-coated balloon (DCB) versus drug-eluting stent (DES) remain unknown. The study sought to investigate whether treatment of de novo SVD with DCB yields similar functional results compared with DES, as judged with angiography-based quantitative flow ratio (QFR). Methods and results QFR was measured at pre-procedural, post-procedural and 9-month angiography in all available subjects from the non-inferiority RESTORE SVD China trial, in which patients were randomized to Restore DCB (n = 116) or Resolute DES (n = 114) study arms. Primary outcome of this analysis was 9-month QFR. Pre-procedural, post-procedural and 9-month QFR was performed in 84.8% (195/230), 83.0% (191/230) and 93.8% (181/193) cases, respectively. At 9 months, the QFR of DCB showed no significant difference to DES (0.88 ± 0.23 vs. 0.92 ± 0.12, p = 0.12). Both 9-month QFR and the QFR difference between post-procedure and 9-month follow-up were correlated with angiographic percentage of diameter stenosis and late loss, and predictive of 2-year clinical outcome. Conclusions Treatment of coronary SVD with DCB resulted in similar 9-month functional results compared with DES. This study provides evidences to the value of QFR as a mean of evaluating device performance after coronary revascularization. Clinical trial registration URL: https://www.clinicaltrials.gov; ClinicalTrial.gov: Identifier: NCT02946307.",2020,"At 9 months, the QFR of DCB showed no significant difference to DES (0.88 ± 0.23 vs. 0.92 ± 0.12, p = 0.12).",['small coronary vessels'],"['DCB', 'DES', 'drug-coated balloons versus drug- eluting stents', 'Restore DCB', 'drug-coated balloon (DCB) versus drug-eluting stent (DES', 'Resolute DES']","[' Pre-procedural, post-procedural and 9-month QFR', 'QFR of DCB', 'angiography-based quantitative flow ratio (QFR', '9-month QFR']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",,0.132006,"At 9 months, the QFR of DCB showed no significant difference to DES (0.88 ± 0.23 vs. 0.92 ± 0.12, p = 0.12).","[{'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Meng', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yinxiao', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Zhihao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'JetMed, Beijing, China.'}, {'ForeName': 'Kaiyuan', 'Initials': 'K', 'LastName': 'Zou', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ruan', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ruofei', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Zening', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China. Electronic address: jin_zening@163.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Catheterization Laboratories, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; National Clinical Research Centre for Cardiovascular Diseases, Beijing, China. Electronic address: bxu@citmd.com.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.11.035']
1661,33227385,Individual differences and moderating participant characteristics in the effect of reducing portion size on meal energy intake: Pooled analysis of three randomized controlled trials.,"Portion size impacts on the amount of energy consumed during a meal. However, research findings on participant characteristics that moderate the effect of portion size on energy intake are mixed. Using data pooled across three randomized control trials, we examined the impact of reducing meal portion size on meal energy intake in 111 adult participants varying in sex (55 M, 56 F), body weight (BMI range = 19-42) and a broad range of participant characteristics, including usual portion size, restrained, emotional and external eating, satiety responsiveness, plate clearing tendencies, concerns about wasting food and self-control. In each trial, a repeated-measures design was used and participants consumed three ad-libitum lunchtime meals differing in portion size; large-normal portion size condition (100%) vs. small-normal portion size condition (~ 75%) vs. smaller than normal portion size condition (~ 50%). In mixed ANOVAs, we did not find convincing evidence that any participant characteristic reliably moderated the impact that reducing portion size had on energy intake. For the majority of participants energy intake decreased when portion size was reduced and it was more common for participants to consistently reduce their energy intake than consume a similar amount when portion size was reduced. We also found little evidence that a sub-group of participants existed whose energy intake was consistently resistant to portion size reductions. Portion size may be a universal driver of energy intake, as reducing meal portion size appears to decrease meal energy intake among most people. Food portion downsizing may therefore be an equitable intervention approach to reducing population level energy intake.",2020,For the majority of participants energy intake decreased when portion size was reduced and it was more common for participants to consistently reduce their energy intake than consume a similar amount when portion size was reduced.,"['111 adult participants varying in sex (55M, 56F), body weight (BMI range = 19-42) and a broad range of participant characteristics, including usual portion size, restrained, emotional and external eating, satiety responsiveness, plate clearing tendencies, concerns about wasting food and self-control']",[],[],"[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",[],[],111.0,0.0988911,For the majority of participants energy intake decreased when portion size was reduced and it was more common for participants to consistently reduce their energy intake than consume a similar amount when portion size was reduced.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, L69 7ZA, UK. Electronic address: eric.robinson@liverpool.ac.uk.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'Haynes', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, L69 7ZA, UK; Centre for Behavioural Research in Cancer, Cancer Council Victoria, Melbourne, Australia. Electronic address: ashleigh.haynes@cancervic.org.au.'}]",Appetite,['10.1016/j.appet.2020.105047']
1662,33227913,Effect of 4 Weeks of Anti-Gravity Treadmill Training on Isokinetic Muscle Strength and Muscle Activity in Adults Patients with a Femoral Fracture: A Randomized Controlled Trial.,"This study aimed to identify the effect of anti-gravity treadmill training on isokinetic lower-limb muscle strength and muscle activities in patients surgically treated for a hip fracture. A total of 34 participants were randomly assigned into two groups: anti-gravity treadmill training group ( n = 17) and control group ( n = 17). The isokinetic muscle strength and endurance of hip flexor and extensor and the activities of the vastus lateralis (VL), vastus medialis (VM), gluteus maximus (GM), and gluteus medialis (Gm) muscles were measured before and after 4 weeks of the interventions. Significant improvements were observed in isokinetic muscle strength and endurance of hip flexors and extensors in both groups ( p < 0.05); however, no significant differences were observed between the groups ( p > 0.05) except for muscle strength of the hip extensor ( d = 0.78, p = 0029). Statistically significant increases in the muscle activity of VL, VM, GM, and Gm were found before and after the intervention ( p < 0.05), and significant differences in muscle activities of GM ( d = 2.64, p < 0.001) and Gm ( d = 2.59, p < 0.001) were observed between the groups. Our results indicate that both groups showed improvement in muscle strength, endurance, and activities after the intervention. Additionally, anti-gravity treadmill training improved significantly more muscle strength at 60°/s of the hip extensor and gluteus muscle activities than conventional therapy, which may be appropriate for patients with hip fracture surgery.",2020,"Significant improvements were observed in isokinetic muscle strength and endurance of hip flexors and extensors in both groups ( p < 0.05); however, no significant differences were observed between the groups ( p > 0.05) except for muscle strength of the hip extensor ( d = 0.78, p = 0029).","['Adults Patients with a Femoral Fracture', '34 participants', 'patients with hip fracture surgery', 'patients surgically treated for a hip fracture']","['Anti-Gravity Treadmill Training', 'anti-gravity treadmill training']","['isokinetic muscle strength and endurance of hip flexors and extensors', 'muscle strength', 'isokinetic muscle strength and endurance of hip flexor and extensor and the activities of the vastus lateralis (VL), vastus medialis (VM), gluteus maximus (GM), and gluteus medialis ', 'isokinetic lower-limb muscle strength and muscle activities', 'Isokinetic Muscle Strength and Muscle Activity', 'muscle strength of the hip extensor', 'muscle activities of GM', 'muscle strength, endurance, and activities', 'muscle activity of VL, VM, GM, and Gm']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}]","[{'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0224424', 'cui_str': 'Structure of gluteus maximus muscle'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",34.0,0.0174252,"Significant improvements were observed in isokinetic muscle strength and endurance of hip flexors and extensors in both groups ( p < 0.05); however, no significant differences were observed between the groups ( p > 0.05) except for muscle strength of the hip extensor ( d = 0.78, p = 0029).","[{'ForeName': 'Pyeongon', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Ansan Hospital, Ansan 15324, Korea.'}, {'ForeName': 'Haneul', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon 21936, Korea.'}, {'ForeName': 'Wonho', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Department of Physical Therapy, Gachon University, Incheon 21936, Korea.'}, {'ForeName': 'Sangmi', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Occupational Therapy, SangGi Youngseo College, Wonju 26339, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17228572']
1663,33227990,Nursing Students' Relational Skills with Elders Improve through Humanitude Care Methodology.,"Nursing students have difficulties interacting with cognitively impaired elders. This study aimed to identify students' difficulties in interacting with elders, the causes of the difficulties in interacting with elders, the strategies used to reduce these difficulties, and the importance attributed to the Structured Sequence of Humanitude Care Procedures (SSHCP). It also aimed to assess the contribution of the Humanitude Care Methodology (HCM) to the development of interaction skills in nursing students. An exploratory descriptive study with a quasi-experimental design was conducted with a sample of 64 nursing students during their hospital clinical training. A control group (usual training) and an experimental group (HCM training) were used. Data were collected through a questionnaire applied at baseline and follow-up. Content analysis, chi-square tests, and Student's t-tests were performed. The main difficulty identified was caring for agitated and confused elders. Difficulties were associated with a lack of theoretical-practical teaching, the clinical training context, lack of experience, and personality traits. HCM impacted positively on the development of students' interaction skills. This study shows that HCM is an innovative methodology in nursing education that will allow for moving from an instrumental and technicist education into a more humanized training capable of transforming care.",2020,"Difficulties were associated with a lack of theoretical-practical teaching, the clinical training context, lack of experience, and personality traits.","['nursing students', 'Nursing students have difficulties interacting with cognitively impaired elders', '64 nursing students during their hospital clinical training', ""students' difficulties in interacting with elders""]","['Humanitude Care Methodology (HCM', 'control group (usual training) and an experimental group (HCM training', 'HCM']",[],"[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],64.0,0.0156958,"Difficulties were associated with a lack of theoretical-practical teaching, the clinical training context, lack of experience, and personality traits.","[{'ForeName': 'Rosa Cândida Carvalho Pereira', 'Initials': 'RCCP', 'LastName': 'Melo', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra (ESEnfC), 3046-851 Coimbra, Portugal.'}, {'ForeName': 'Paulo Joaquim Pina', 'Initials': 'PJP', 'LastName': 'Queirós', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra (ESEnfC), 3046-851 Coimbra, Portugal.'}, {'ForeName': 'Luiza Hiromi', 'Initials': 'LH', 'LastName': 'Tanaka', 'Affiliation': 'Department of Collective Health, Paulista School of Nursing, Federal University of São Paulo, São Paulo 04024-002, Brazil.'}, {'ForeName': 'Liliana Vanessa Lúcio', 'Initials': 'LVL', 'LastName': 'Henriques', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra (ESEnfC), 3046-851 Coimbra, Portugal.'}, {'ForeName': 'Hugo Leiria', 'Initials': 'HL', 'LastName': 'Neves', 'Affiliation': 'Health Sciences Research Unit: Nursing (UICISA: E), Nursing School of Coimbra (ESEnfC), 3046-851 Coimbra, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17228588']
1664,33228006,Time Course and Determinants of Individual Motivation among Women Enrolled in a Diet and Physical Activity Primary Prevention Trial.,"We studied the determinants of motivation among post-menopausal women enrolled in a two-year diet and physical activity primary prevention randomized trial. Participants were requested to grade the importance attached to changing their lifestyle, their confidence about being able to implement the change, and their willingness to be involved in studies focusing on lifestyle. We used multi-adjusted regression to investigate the association between individual characteristics, study arm, and individual motivation at study entry and end. Participants ( n = 234) were highly motivated both at entry and throughout the study. Women with pre-existing healthier eating habits and lifestyles (e.g., high consumption of fruit and vegetables, low red meat consumption, and physically active) were more motivated at entry and over the course of the study. Women assigned to any intervention arm were more motivated than those in the control arm. These findings may help enhance adherence to recommendations and improve effectiveness of community-based health promotion campaigns.",2020,Women assigned to any intervention arm were more motivated than those in the control arm.,"['Women Enrolled in a Diet and Physical Activity Primary Prevention Trial', 'post-menopausal women enrolled in a two-year diet and physical activity primary prevention randomized trial', 'Participants ( n = 234) were highly motivated both at entry and throughout the study']",[],['Time Course and Determinants of Individual Motivation'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",234.0,0.0214777,Women assigned to any intervention arm were more motivated than those in the control arm.,"[{'ForeName': 'Saverio', 'Initials': 'S', 'LastName': 'Caini', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Melania', 'Initials': 'M', 'LastName': 'Assedi', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Grechi', 'Affiliation': 'The Italian League Against Tumors (LILT), Oncological Rehabilitation Centre (CeRiOn), 50139 Florence, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Ermini', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Zagni', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Occhini', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Castaldo', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Bendinelli', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Palli', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Masala', 'Affiliation': 'Cancer Risk Factors and Life-Style Epidemiology Unit, Institute for Cancer Research, Prevention and Clinical Network (ISPRO), 50139 Florence, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17228589']
1665,33228174,Cost-Effectiveness Analysis from a Randomized Controlled Trial of Tailored Exercise Prescription for Women with Breast Cancer with 8-Year Follow-Up.,"Studies show conflicting results on whether exercise interventions to improve outcomes for women with breast cancer are cost-effective. We modelled the long-term cost-effectiveness of the Exercise for Health intervention compared with usual care. A lifetime Markov cohort model for women with early breast cancer was constructed taking a societal perspective. Data were obtained from trial, epidemiological, quality of life, and healthcare cost reports. Outcomes were calculated from 5000 Monte Carlo simulations, and one-way and probabilistic sensitivity analyses. Over the cohort's remaining life, the incremental cost for the exercise versus usual care groups were $7409 and quality-adjusted life years (QALYs) gained were 0.35 resulting in an incremental cost per QALY ratio of AU$21,247 (95% Uncertainty Interval (UI): Dominant, AU$31,398). The likelihood that the exercise intervention was cost-effective at acceptable levels was 93.0%. The incremental cost per life year gained was AU$8894 (95% UI Dominant, AU$11,769) with a 99.4% probability of being cost effective. Findings were most sensitive to the probability of recurrence in the exercise and usual care groups, followed by the costs of out-of-pocket expenses and the model starting age. This exercise intervention for women after early-stage breast cancer is cost-effective and would be a sound investment of healthcare resources.",2020,The incremental cost per life year gained was AU$8894,"['Women with Breast Cancer with 8-Year Follow-Up', 'women with early breast cancer', 'women with breast cancer', 'women after early-stage breast cancer']","['exercise intervention', 'Tailored Exercise Prescription', 'Exercise for Health intervention', 'exercise interventions']",['cost-effective at acceptable levels'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0406727,The incremental cost per life year gained was AU$8894,"[{'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Gordon', 'Affiliation': 'Population Health Department, QIMR Berghofer Medical Research Institute, Locked Bag 2000, Royal Brisbane Hospital, Brisbane, Qld 4029, Australia.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Eakin', 'Affiliation': 'Faculty of Medicine, School of Public Health, The University of Queensland, Herston, Brisbane, Qld 4006, Australia.'}, {'ForeName': 'Rosalind R', 'Initials': 'RR', 'LastName': 'Spence', 'Affiliation': 'Menzies Health Institute Qld, Griffith University, Nathan, Brisbane, Qld 4111, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pyke', 'Affiliation': 'Mater Public and Private Hospital, South Brisbane, Qld 4101, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bashford', 'Affiliation': 'The Wesley Hospital, Auchenflower, Brisbane, Qld 4066, Australia.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'Faculty of Health and Medical Sciences, University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Hayes', 'Affiliation': 'Menzies Health Institute Qld, Griffith University, Nathan, Brisbane, Qld 4111, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17228608']
1666,32736891,The effect of linagliptin on renal progression in type-2 diabetes mellitus patients with chronic kidney disease: A prospective randomized controlled study.,"BACKGROUND
Linagliptin does not require dose adjustment in diabetes mellitus patients with chronic kidney disease (CKD). But, renal effects of linagliptin are not clear. Our aim was to examine the effect of linagliptin on renal disease progression in only insulin dependent type 2 diabetes mellitus (DM) patients with CKD.
METHODS
Stage 3-4 CKD patients were randomized into 2 groups in this prospective randomized controlled study. In the first group, linagliptin 5mg was added in addition to the background insulin therapy. In the second group, patients continued their insulin therapy. Patients were followed up at 3-month intervals for one year.
RESULTS
The study population consisted of 164 patients (90 patients in linagliptin group, 74 patients in other group) with a mean age of 67.5±8.8 years. eGFR significantly increased in linagliptin group (p=0.033), but decreased in other group (p=0.003). No significant change was observed in total insulin dose in linagliptin group (p=0.111), but in other group, total insulin dose significantly increased (p<0.001). Proteinuria levels decreased in both groups, but there was no significant change. In the multiple logistic regression analysis, male gender and proteinuria emerged as variables that showed significant association with increased risk and the use of linagliptin emerged as variable that showed significant association with decreased risk for CKD progression.
CONCLUSION
Linagliptin in DM patients with CKD was able to improve renal progression without significant effect on proteinuria and glucose control. With regard to treating diabetic nephropathy, linagliptin may offer a new therapeutic approach.",2020,Linagliptin in DM patients with CKD was able to improve renal progression without significant effect on proteinuria and glucose control.,"['diabetes mellitus patients with chronic kidney disease (CKD', 'only insulin dependent type 2 diabetes mellitus (DM) patients with CKD.\nMETHODS\n\n\nStage 3-4 CKD patients', 'group, 74 patients in other group) with a mean age of 67.5±8.8 years', 'DM patients with CKD', '164 patients (90 patients in', 'type-2 diabetes mellitus patients with chronic kidney disease']","['Linagliptin', 'linagliptin']","['Proteinuria levels', 'renal progression', 'renal disease progression', 'eGFR', 'proteinuria and glucose control', 'total insulin dose']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}]","[{'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",164.0,0.0171951,Linagliptin in DM patients with CKD was able to improve renal progression without significant effect on proteinuria and glucose control.,"[{'ForeName': 'Ali Ihsan', 'Initials': 'AI', 'LastName': 'Yagoglu', 'Affiliation': 'Department of Internal Medicine, Kayseri City Training and Research Hospital, Kayseri, Turkey. Electronic address: ali.ihsan.yagoglu@gmail.com.'}, {'ForeName': 'Oguzhan Sıtkı', 'Initials': 'OS', 'LastName': 'Dizdar', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Kayseri City Training and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Erdem', 'Affiliation': 'Department of Internal Medicine, Kayseri City Training and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Berkan', 'Initials': 'B', 'LastName': 'Akcakaya', 'Affiliation': 'Department of Internal Medicine, Kayseri City Training and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Ali Ihsan', 'Initials': 'AI', 'LastName': 'Gunal', 'Affiliation': 'Department of Internal Medicine Division of Nephrology, Kayseri City Training and Research Hospital, Kayseri, Turkey.'}]",Nefrologia : publicacion oficial de la Sociedad Espanola Nefrologia,['10.1016/j.nefro.2020.04.023']
1667,32736928,"The DaBlaCa-13 Study: Short-term, Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations in Non-muscle-invasive Bladder Cancer-A Randomised Controlled Trial.","BACKGROUND
Instillation therapy for non-muscle-invasive bladder cancer (NMIBC) reduces recurrences but is associated with side effects. Preoperative instillation of chemotherapy could potentially be associated with fewer side effects compared with adjuvant instillations and in some patients make tumour resection (transurethral resection of the bladder tumour [TURBT]) superfluous.
OBJECTIVE
To investigate tumour response and adverse events related to short-term, intensive chemoresection with mitomycin C compared with adjuvant instillations in patients with recurrent NMIBC.
DESIGN, SETTING, AND PARTICIPANTS
A randomised, controlled trial was conducted in two urological departments in Denmark from January 2018 to June 2019. In total, 120 participants with a history of Ta bladder tumours, low grade or high grade, were included upon recurrence.
INTERVENTION
Intravesical mitomycin C (40 mg/40 ml) three times a week for 2 wk in the intervention group (59 patients) was compared with TURBT and six weekly adjuvant instillations in the control group (61 patients).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Tumour response was evaluated in the intervention group by flexible cystoscopy after 4 wk. Side effects were prospectively registered in both groups using the National Cancer Institute's Common Terminology Criteria for Adverse Events. Groups were compared using χ 2 or Fisher's exact test.
RESULTS AND LIMITATIONS
Complete tumour response was seen in 33 participants (57%) in the intervention group. Fewer adverse events were reported in the intervention group than in the control group. Two patients in each group ceased instillation treatment due to adverse events. The main limitation is the current lack of long-term follow-up.
CONCLUSIONS
Short-term, intensive chemoresection yields a tumour response of 57%. Hence, only half of those treated with chemoresection needed TURBT. The treatment was furthermore associated with fewer clinically significant side effects. Owing to small numbers, further investigations on Ta high-grade tumours are needed.
PATIENT SUMMARY
We compared a nonsurgical treatment with standard treatment in patients with superficial bladder tumours. We found it to be safe and able to avoid surgery in more than half of the patients.",2020,Fewer adverse events were reported in the intervention group than in the control group.,"['two urological departments in Denmark from January 2018 to June 2019', '120 participants with a history of Ta bladder tumours, low grade or high grade, were included upon recurrence', 'Non-muscle-invasive Bladder Cancer', 'patients with superficial bladder tumours', 'patients with recurrent NMIBC']","['Intensive Chemoresection Versus Standard Adjuvant Intravesical Instillations', 'TURBT', 'mitomycin C', 'Intravesical mitomycin C', 'chemotherapy']","['Side effects', 'adverse events', 'Tumour response', 'side effects']","[{'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",120.0,0.0896226,Fewer adverse events were reported in the intervention group than in the control group.,"[{'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Lindgren', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark; Department of Urology, Regional Hospital West Jutland, Holstebro, Denmark; Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark. Electronic address: maalin@rm.dk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bue', 'Affiliation': 'Department of Urology, Regional Hospital West Jutland, Holstebro, Denmark.'}, {'ForeName': 'Nessn', 'Initials': 'N', 'LastName': 'Azawi', 'Affiliation': 'Department of Urology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Linea', 'Initials': 'L', 'LastName': 'Blichert-Refsgaard', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Maria O', 'Initials': 'MO', 'LastName': 'Sundelin', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark; Department of Urology, Regional Hospital West Jutland, Holstebro, Denmark; Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Dyrskjøt', 'Affiliation': 'Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark; Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jørgen B', 'Initials': 'JB', 'LastName': 'Jensen', 'Affiliation': 'Department of Urology, Aarhus University Hospital, Aarhus, Denmark; Department of Urology, Regional Hospital West Jutland, Holstebro, Denmark; Department of Clinical Medicine, Health, Aarhus University, Aarhus, Denmark.'}]",European urology,['10.1016/j.eururo.2020.07.009']
1668,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES
IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS
A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2 were used to characterize immune responders (IR).
RESULTS
Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS
The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS
Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS
Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
1669,32743900,Does intensity of stimulus and culture matter in death anxiety?,"Two experiments were designed to study the effect of mortality salience (MS) and terror attack news on socioreligious attribution of Muslims in Pakistan. The first sample of students (n = 238) was taken from public and private universities of Pakistan. The age range of the sample was 18-37 years. Participants were randomly assigned to one of eight conditions: 2 (MS vs. pain salience) × 4 (non-Muslims attacking Muslims vs. Muslims attacking non-Muslims vs. Muslims attacking Muslims vs. weather news). Results indicated a non-significant main effect of MS (p = .83) on socioreligious attribution. Similarly, a non-significant interaction effect (p = .76.) on socioreligious attribution was found. However, the main effect of terror news was significant (p = .01). Post hoc analyses revealed that individuals exposed to the news video showing Muslims attacking non-Muslims scored significantly higher than the rest. Study II was conducted to compare the results of Study I by observing the effect of MS and four news videos after introducing MS through death simulation. The sample of students (n = 120) was taken from public and private universities of Rawalpindi and Islamabad. The age range of the sample was 18-37 years. Participants were randomly assigned to one of eight conditions: 2 (MS vs. pain salience) × 4 (non-Muslims attacking Muslims vs. Muslims attacking non-Muslims vs. Muslims attacking Muslims vs. weather news). Results indicated a significant main effect of MS (p = .001) on socioreligious attribution. Similarly, findings indicated a significant interaction effect (ρ = .001) on socioreligious attribution. These studies were conducted within the culture and religion in question. Further studies on terror management theory are needed in Pakistan to benefit from the work being done on post-traumatic stress disorder with reference to Pakistan.",2020,Post hoc analyses revealed that individuals exposed to the news video showing Muslims attacking non-Muslims scored significantly higher than the rest.,"['students (n = 238) was taken from public and private universities of Pakistan', 'sample of students (n = 120) was taken from public and private universities of Rawalpindi and Islamabad', 'Muslims in Pakistan', 'The age range of the sample was 18-37\u2009years']",['eight conditions: 2 (MS vs. pain salience'],"['mortality salience (MS', 'socioreligious attribution']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",238.0,0.0231727,Post hoc analyses revealed that individuals exposed to the news video showing Muslims attacking non-Muslims scored significantly higher than the rest.,"[{'ForeName': 'Saiyida', 'Initials': 'S', 'LastName': 'Tasmeera', 'Affiliation': 'Department of Psychology, Foundation University Islamabad, Rawalpindi, Pakistan.'}, {'ForeName': 'Tanvir', 'Initials': 'T', 'LastName': 'Akhtar', 'Affiliation': 'Department of Psychology, Foundation University Islamabad, Rawalpindi, Pakistan.'}, {'ForeName': 'M Yasir Masood', 'Initials': 'MYM', 'LastName': 'Afaq', 'Affiliation': 'Department of Psychology, National University of Modern Languages, Islamabad, Pakistan.'}]",PsyCh journal,['10.1002/pchj.380']
1670,33231638,"Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability: An Ancillary Study of the Look AHEAD Study.","Importance
Intensive lifestyle interventions focused on diet and exercise can reduce weight and improve diabetes management. However, the long-term effects on health care use and spending are unclear, especially for public payers.
Objective
To estimate the association of effective intensive lifestyle intervention for weight loss with long-term health care use and Medicare spending.
Design, Setting, and Participants
This ancillary study used data from the Look AHEAD randomized clinical trial, which randomized participants with type 2 diabetes to an intensive lifestyle intervention or control group (ie, diabetes support and education), provided ongoing intervention from 2001 to 2012, and demonstrated improved diabetes management and reduced health care costs during the intervention. This study compared Medicare data between study arms from 2012 to 2015 to determine whether the intervention was associated with persistent reductions in health care spending.
Exposure
Starting in 2001, Look AHEAD's intervention group participated in sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists with the goal of reducing weight 7% in the first year. Sessions occurred weekly in the first 6 months of the intervention and decreased over the intervention period. The controls participated in periodic group education sessions that occurred 3 times per year in the first year and decreased to 1 time per year later in the trial.
Main Outcomes and Measures
Outcomes included total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility.
Results
This study matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages). Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women). There was no statistically significant difference in total Medicare spending between groups (difference, -$133 [95% CI, -$1946 to $1681]; P = .89). In the intervention group, compared with the control group, there was statistically significantly higher Part B spending (difference, $513 [95% CI, $70 to $955]; P = .02) but lower prescription drug costs (difference, -$803 [95% CI, -$1522 to -$83]; P = .03).
Conclusions and Relevance
This ancillary study of a randomized clinical trial found that reductions in health care use and spending associated with an intensive lifestyle intervention for type 2 diabetes diminished as participants aged. Intensive lifestyle interventions may need to be sustained to reduce long-term health care spending.
Trial Registration
ClinicalTrials.gov Identifier: NCT03952728.",2020,"There was no statistically significant difference in total Medicare spending between groups (difference, -$133","['matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages', 'participants with type 2 diabetes to an', 'Type 2 Diabetes With Health Care Use, Spending, and Disability', 'type 2 diabetes diminished as participants aged', 'Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women']","['sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists', 'intensive lifestyle intervention', 'Intensive lifestyle interventions', 'Intensive Lifestyle Intervention', 'intensive lifestyle intervention or control group (ie, diabetes support and education']","['prescription drug costs', 'total Medicare spending', 'total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility', 'weight and improve diabetes management', 'diabetes management and reduced health care costs', 'higher Part B spending']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C3536818', 'cui_str': 'Dietitian'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0205250', 'cui_str': 'High'}]",5145.0,0.0859843,"There was no statistically significant difference in total Medicare spending between groups (difference, -$133","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Huckfeldt', 'Affiliation': 'Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frenier', 'Affiliation': 'Division of Health Policy and Management, University of Minnesota School of Public Health, Minneapolis.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Pajewski', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Casanova', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University, New York, New York.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Cheskin', 'Affiliation': 'George Mason University, Fairfax, Virginia.'}, {'ForeName': 'Dana P', 'Initials': 'DP', 'LastName': 'Goldman', 'Affiliation': 'Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.25488']
1671,33231663,Effect of Nebulized Magnesium vs Placebo Added to Albuterol on Hospitalization Among Children With Refractory Acute Asthma Treated in the Emergency Department: A Randomized Clinical Trial.,"Importance
While intravenous magnesium decreases hospitalizations in refractory pediatric acute asthma, it is variably used because of invasiveness and safety concerns. The benefit of nebulized magnesium to prevent hospitalization is unknown.
Objective
To evaluate the effectiveness of nebulized magnesium in children with acute asthma remaining in moderate or severe respiratory distress after initial therapy.
Design, Setting, and Participants
A randomized double-blind parallel-group clinical trial from September 26, 2011, to November 19, 2019, in 7 tertiary-care pediatric emergency departments in Canada. The participants were otherwise healthy children aged 2 to 17 years with moderate to severe asthma defined by a Pediatric Respiratory Assessment Measure (PRAM) score of 5 or greater (on a 12-point scale) after a 1-hour treatment with an oral corticosteroid and 3 inhaled albuterol and ipratropium treatments. Of 5846 screened patients, 4332 were excluded for criteria, 273 declined participation, 423 otherwise excluded, 818 randomized, and 816 analyzed.
Interventions
Participants were randomized to 3 nebulized albuterol treatments with either magnesium sulfate (n = 410) or 5.5% saline placebo (n = 408).
Main Outcomes and Measures
The primary outcome was hospitalization for asthma within 24 hours. Secondary outcomes included PRAM score; respiratory rate; oxygen saturation at 60, 120, 180, and 240 minutes; blood pressure at 20, 40, 60, 120, 180, and 240 minutes; and albuterol treatments within 240 minutes.
Results
Among 818 randomized patients (median age, 5 years; 63% males), 816 completed the trial (409 received magnesium; 407, placebo). A total of 178 of the 409 children who received magnesium (43.5%) were hospitalized vs 194 of the 407 who received placebo (47.7%) (difference, -4.2%; absolute risk difference 95% [exact] CI, -11% to 2.8%]; P = .26). There were no significant between-group differences in changes from baseline to 240 minutes in PRAM score (difference of changes, 0.14 points [95% CI, -0.23 to 0.50]; P = .46); respiratory rate (0.17 breaths/min [95% CI, -1.32 to 1.67]; P = .82); oxygen saturation (-0.04% [95% CI, -0.53% to 0.46%]; P = .88); systolic blood pressure (0.78 mm Hg [95% CI, -1.48 to 3.03]; P = .50); or mean number of additional albuterol treatments (magnesium: 1.49, placebo: 1.59; risk ratio, 0.94 [95% CI, 0.79 to 1.11]; P = .47). Nausea/vomiting or sore throat/nose occurred in 17 of the 409 children who received magnesium (4%) and 5 of the 407 who received placebo (1%).
Conclusions and Relevance
Among children with refractory acute asthma in the emergency department, nebulized magnesium with albuterol, compared with placebo with albuterol, did not significantly decrease the hospitalization rate for asthma within 24 hours. The findings do not support use of nebulized magnesium with albuterol among children with refractory acute asthma.
Trial Registration
ClinicalTrials.gov Identifier: NCT01429415.",2020,"There were no significant between-group differences in changes from baseline to 240 minutes in PRAM score (difference of changes, 0.14 points [95% CI, -0.23 to 0.50]; P = .46); respiratory rate (0.17 breaths/min [95% CI, -1.32 to 1.67]; P = .82); oxygen saturation (-0.04% [95% CI, -0.53% to 0.46%]; P = .88); systolic blood pressure (0.78 mm Hg [95% CI, -1.48 to 3.03]; P = .50); or mean number of additional albuterol treatments (magnesium: 1.49, placebo: 1.59; risk ratio, 0.94 [95% CI, 0.79 to 1.11]; P = .47).","['refractory pediatric acute asthma', 'children with refractory acute asthma in the emergency department', 'A total of 178 of the 409 children who received magnesium (43.5%) were hospitalized vs 194 of the 407 who received', 'participants were otherwise healthy children aged 2 to 17 years with moderate to severe asthma defined by a Pediatric Respiratory Assessment Measure (PRAM) score of 5 or greater (on a 12-point scale) after a 1-hour treatment with an', 'Children', '818 randomized patients (median age, 5 years; 63% males', 'children with acute asthma remaining in moderate or severe respiratory distress after initial therapy', 'children with refractory acute asthma', 'September 26, 2011, to November 19, 2019, in 7 tertiary-care pediatric emergency departments in Canada', '5846 screened patients, 4332 were excluded for criteria, 273 declined participation, 423 otherwise excluded, 818 randomized, and 816 analyzed']","['magnesium; 407, placebo', 'placebo with albuterol', 'Nebulized Magnesium vs Placebo', 'nebulized magnesium', 'placebo', 'nebulized albuterol treatments with either magnesium sulfate (n\u2009=\u2009410) or 5.5% saline placebo', 'Albuterol', 'magnesium', 'nebulized magnesium with albuterol', 'oral corticosteroid and 3 inhaled albuterol and ipratropium treatments']","['systolic blood pressure', 'PRAM score; respiratory rate; oxygen saturation at 60, 120, 180, and 240 minutes; blood pressure', 'respiratory rate', 'hospitalization rate', 'Nausea/vomiting or sore throat/nose', 'PRAM score', 'hospitalization for asthma within 24 hours', 'oxygen saturation']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0582415', 'cui_str': 'Acute asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0549075', 'cui_str': 'Respiratory assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0549075', 'cui_str': 'Respiratory assessment'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]",818.0,0.812441,"There were no significant between-group differences in changes from baseline to 240 minutes in PRAM score (difference of changes, 0.14 points [95% CI, -0.23 to 0.50]; P = .46); respiratory rate (0.17 breaths/min [95% CI, -1.32 to 1.67]; P = .82); oxygen saturation (-0.04% [95% CI, -0.53% to 0.46%]; P = .88); systolic blood pressure (0.78 mm Hg [95% CI, -1.48 to 3.03]; P = .50); or mean number of additional albuterol treatments (magnesium: 1.49, placebo: 1.59; risk ratio, 0.94 [95% CI, 0.79 to 1.11]; P = .47).","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schuh', 'Affiliation': 'Division of Pediatric Emergency Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Sweeney', 'Affiliation': 'Division of Pediatric Emergency Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Rumantir', 'Affiliation': 'Division of Pediatric Emergency Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Allan L', 'Initials': 'AL', 'LastName': 'Coates', 'Affiliation': 'Division of Respiratory Medicine, Research Institute, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Willan', 'Affiliation': 'Ontario Child Health Support Unit, SickKids Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Stephens', 'Affiliation': 'Research Institute, Clinical Research Services, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Eshetu G', 'Initials': 'EG', 'LastName': 'Atenafu', 'Affiliation': 'Department of Biostatistics, Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'Research Institute, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thompson', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Zemek', 'Affiliation': ""Department of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Plint', 'Affiliation': ""Department of Pediatrics and Emergency Medicine, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Ontario, Canada.""}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Gravel', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, Montréal, Quebec, Canada.'}, {'ForeName': 'Francine M', 'Initials': 'FM', 'LastName': 'Ducharme', 'Affiliation': 'Department of Pediatric Emergency Medicine, CHU Sainte-Justine, Montréal, Quebec, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': ""Departments of Pediatrics, Emergency Medicine, and Physiology & Pharmacology, Alberta Children's Hospital, Calgary, Alberta, Canada.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Black', 'Affiliation': ""Division of Pediatric Emergency Medicine, British Columbia Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Curtis', 'Affiliation': ""Departments of Pediatrics and Emergency Medicine, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Beer', 'Affiliation': 'Pediatrics/Pediatric Emergency Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Klassen', 'Affiliation': 'Department of Pediatrics and Child Health, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Nicksy', 'Affiliation': 'Pharmacy Department, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Departments of Pediatrics and Emergency Medicine, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.19839']
1672,33227549,Longitudinal effects of smoking cessation on carotid artery atherosclerosis in contemporary smokers: The Wisconsin Smokers Health Study.,"BACKGROUND AND AIMS
We quantified the effects of smoking and smoking cessation on carotid artery atherosclerosis and wall thickness in two unique cohorts of smokers making a quit attempt.
METHODS
Our primary analysis included 726 smokers making a quit attempt in a randomized clinical trial with long-term follow-up. Our secondary analysis included 889 smokers making a quit attempt in a subsequent trial. Participants underwent carotid artery ultrasonography at baseline and up to 3 subsequent visits. Primary outcomes were changes in carotid plaque score and intima media-thickness (IMT). We calculated a smoking burden score (SBS) that reflected the number of visits in which participants reported smoking after the quit attempt. Multivariable regression examined relations between SBS and carotid artery outcomes with adjustments for cardiovascular disease risk factors.
RESULTS
In the primary analysis, participants were mean (standard deviation) 46.1 (10.3) years old (57.9% female) and smoked 21.1 (8.9) cigarettes per day (CPD). After a median of 7 years, lower SBS predicted less increase in carotid plaque score (Chi-squared = 13.0, p = 0.012). SBS independently predicted change in carotid plaque score (p = 0.007; SBS 0 vs 4) as did baseline CPD (p = 0.024) and age (p<0.0001). SBS did not affect carotid IMT change. In the secondary analysis, increasing SBS was associated with increased likelihood of new plaques over 3 years among participants that smoked ≥15 CPD, (Chi-squared = 6.51, p = 0.011).
CONCLUSIONS
Smoking cessation is associated with less progression of carotid plaque, but not IMT. Salutary associations of smoking cessation with carotid plaque progression are related to degree of abstinence.",2020,SBS independently predicted change in carotid plaque score (p = 0.007; SBS 0 vs 4) as did baseline CPD (p = 0.024) and age (p<0.0001).,"['726 smokers making a quit attempt in a randomized clinical trial with long-term follow-up', 'contemporary smokers', '889 smokers making a quit attempt in a subsequent trial', 'participants were mean (standard deviation) 46.1 (10.3) years old (57.9% female) and smoked 21.1 (8.9) cigarettes per day (CPD']","['smoking and smoking cessation', 'smoking cessation', 'carotid artery ultrasonography']","['carotid IMT change', 'carotid plaque score and intima media-thickness (IMT', 'carotid artery atherosclerosis and wall thickness', 'likelihood of new plaques', 'carotid plaque score', 'carotid artery atherosclerosis', 'smoking burden score (SBS', 'SBS']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",889.0,0.0856124,SBS independently predicted change in carotid plaque score (p = 0.007; SBS 0 vs 4) as did baseline CPD (p = 0.024) and age (p<0.0001).,"[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Stein', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, CSC-H4/520, Madison, WI, 53792, USA. Electronic address: jhs@medicine.wisc.edu.'}, {'ForeName': 'Stevens S', 'Initials': 'SS', 'LastName': 'Smith', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, CSC-H4/520, Madison, WI, 53792, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Hansen', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, CSC-H4/520, Madison, WI, 53792, USA.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Korcarz', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, CSC-H4/520, Madison, WI, 53792, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, CSC-H4/520, Madison, WI, 53792, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, CSC-H4/520, Madison, WI, 53792, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'University of Wisconsin School of Medicine and Public Health, 600 Highland Avenue, CSC-H4/520, Madison, WI, 53792, USA.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.11.010']
1673,33227553,A comparison of open-label and deceptive placebo analgesia in a healthy sample.,"OBJECTIVES
A small number of studies have supported the efficacy of open-label placebos (OLPs) in reducing pain. However, research comparing the effectiveness of OLPs with deceptive placebos (DPs) is limited, and the relative impact on pain tolerance versus intensity are not yet understood. This study therefore, examined the effectiveness of a nasal placebo administered openly and deceptively on pain intensity and tolerance during a cold pressor test (CPT).
METHOD
75 healthy participants were allocated to one of three groups; OLP (n = 25), DP (n = 26) and no-treatment (NT; n = 24). A pre-test post-test design was used, with all participants completing a baseline and post-treatment CPT, following placebo administration in the treatment groups.
RESULTS
A one-way ANCOVA revealed significant differences between groups for pain intensity, with planned contrasts revealing that this effect was driven by an increase in pain intensity scores for the NT group within the post treatment CPT, which was not evident in the OLP and DP groups. There were no significant differences between groups for changes in pain tolerance.
CONCLUSION
The increase in pain intensity reported within the post-treatment CPT in the NT group was not apparent in either the OLP or DP groups, with no significant differences between OLP and DP effectiveness. These findings suggest that deception may not be necessary for effective placebo treatment and have implications for the management of pain.",2020,"The increase in pain intensity reported within the post-treatment CPT in the NT group was not apparent in either the OLP or DP groups, with no significant differences between OLP and DP effectiveness.","['healthy sample', '75 healthy participants']","['placebo', 'OLP', 'cold pressor test (CPT', 'OLPs with deceptive placebos (DPs', 'open-label and deceptive placebo analgesia', 'nasal placebo', 'open-label placebos (OLPs']","['pain tolerance', 'pain intensity scores', 'pain intensity', 'pain intensity and tolerance', 'OLP and DP effectiveness']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",75.0,0.146723,"The increase in pain intensity reported within the post-treatment CPT in the NT group was not apparent in either the OLP or DP groups, with no significant differences between OLP and DP effectiveness.","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Disley', 'Affiliation': 'Department of Psychology, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Kola-Palmer', 'Affiliation': 'Department of Psychology, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Retzler', 'Affiliation': 'Department of Psychology, University of Huddersfield, Huddersfield, UK. Electronic address: c.retzler@hud.ac.uk.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110298']
1674,33227558,Breaking the vicious circle of fear and avoidance in children with abdominal pain: A mediation analysis.,"OBJECTIVES
Exposure-based cognitive behavioral therapy via internet (Internet-CBT) has been shown to reduce symptoms and increase quality of life for children with functional abdominal pain disorders (FAPDs), but the mechanisms of change are unknown. The objective was to examine whether a change in symptom-specific fear and avoidance, i.e., gastrointestinal-specific anxiety (GI-anxiety) and gastrointestinal-specific avoidance (GI-avoidance), mediated changes in parent-reported abdominal symptoms for children receiving Internet-CBT compared with children receiving treatment as usual. A further aim was to assess if baseline levels of the proposed mediators moderated the mediation.
METHODS
Weekly assessments of child-reported mediators and parent-reported outcome from 90 children aged 8-12 who were included in a randomized controlled trial were used in univariate and multivariate growth models to test the direct effect of treatment on outcome and the indirect effects via mediators and moderated mediation.
RESULTS
Treatment condition significantly predicted the slope of the mediators (a-path), in favor of Internet-CBT, and mediators were correlated with the outcome (b-path). The indirect effects of the mediators on the outcome (cross-product of the a and b-paths) were significantly different from zero for both GI-avoidance, ab = 1.43, 95%CI [0.42, 3.23]; and GI-anxiety ab = 1.58, 95%CI [0.43, 3.62]. Baseline levels of the proposed mediators moderated the size of the mediation.
CONCLUSIONS
GI-anxiety and GI-avoidance were mediators of change in Internet-CBT and high levels of the mediators at baseline were associated with larger mediated effects. Healthcare professionals should be aware of, and inform families about, the potential benefits of reducing symptom-specific fear and avoidance.",2020,"RESULTS
Treatment condition significantly predicted the slope of the mediators (a-path), in favor of Internet-CBT, and mediators were correlated with the outcome (b-path).","['children with abdominal pain', 'Weekly assessments of child-reported mediators and parent-reported outcome from 90 children aged 8-12 who', 'children with functional abdominal pain disorders (FAPDs', 'children receiving Internet-CBT compared with children receiving treatment as usual']",['Exposure-based cognitive behavioral therapy via internet (Internet-CBT'],"['symptom-specific fear and avoidance, i.e., gastrointestinal-specific anxiety (GI-anxiety) and gastrointestinal-specific avoidance (GI-avoidance', 'slope of the mediators (a-path), in favor of Internet-CBT, and mediators']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0455738', 'cui_str': 'Specific fear'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",90.0,0.0975347,"RESULTS
Treatment condition significantly predicted the slope of the mediators (a-path), in favor of Internet-CBT, and mediators were correlated with the outcome (b-path).","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lalouni', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Solna, Sweden; Stockholm Health Care Services, Stockholm County Council, Sweden; Department of Clinical Neuroscience, Neuro, Karolinska Institutet, Stockholm, Sweden. Electronic address: maria.lalouni@ki.se.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Hesser', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Sweden; Center for Health and Medical Psychology, Örebro University, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Bonnert', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Sweden; Department of Clinical Neuroscience, Osher Center for Integrative Medicine, Karolinska Institutet, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Serlachius', 'Affiliation': 'Stockholm Health Care Services, Stockholm County Council, Sweden; Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Olén', 'Affiliation': ""Department of Medicine, Karolinska Institutet, Solna, Sweden; Department of Paediatric Gastroenterology and Nutrition, Sachs' Children's Hospital, Stockholm, Sweden.""}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatry Research, Karolinska Institutet, Stockholm, Sweden; Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Sweden.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110287']
1675,33227569,"A pilot randomized double-blind, placebo-controlled study on the effects of the topical application of pyridoxine on palmar-plantar erythrodysesthesia (PPE) induced by capecitabine or pegylated liposomal doxorubicin (PLD).","PURPOSE
Palmar-Plantar Erythrodysesthesia (PPE) is a dose-limiting adverse event that commonly occurs with capecitabine and Pegylated Liposomal Doxorubicin-PLD treatment. The study aimed to test the effectiveness of a Pyridoxine (B6) treatment protocol in the management of PPE in patients receiving treatment with capecitabine or pegylated liposomal doxorubicin.
METHODS
This was a pilot randomized double-blind, placebo-controlled study. Patients receiving capecitabine or pegylated liposomal doxorubicin with PPE grade 1 or above were randomly allocated to receive pyridoxine or placebo. The PPE grade, Quality of Life-QoL, Pain and patients' activities of daily living were assessed.
RESULTS
Thirty patients were assigned in the Control and 24 in the Intervention group. No statistically significant difference was found in the PPE grade between baseline and week 6 in the 2 groups (p = 0.263). The control group exhibited worst PPE-associated QoL and higher PAIN levels between baseline and week 6. Respectively, the intervention group showed improved PPE-associated QoL and lower PAIN levels. At week 6, the ECOG status in the Intervention group was improved compared to the control (p = 0.018). Patients in the Intervention group experienced better Global Health Status (p = 0.012), Physical (p = 0.003), Emotional (p = 0.008), and Social function (p < 0.001), lower Fatigue (p = 0.001) and Pain (p = 0.006) compared to Control.
CONCLUSION
Topical pyridoxine was not shown to have an effect on the treatment of PPE. However, results demonstrated its effectiveness on health related QoL, QoL-associated with PPE and pain levels. Due to the high attrition rate further validation of these results in a larger population is warranted. CLINICALTRIALS.
GOV IDENTIFIER
NCT02625415.",2020,"Patients in the Intervention group experienced better Global Health Status (p = 0.012), Physical (p = 0.003), Emotional (p = 0.008), and Social function (p < 0.001), lower Fatigue (p = 0.001) and Pain (p = 0.006) compared to Control.
","['patients receiving treatment with', 'Thirty patients', 'with PPE grade 1 or above']","['pyridoxine', 'placebo', 'capecitabine and Pegylated Liposomal Doxorubicin-PLD', 'Topical pyridoxine', 'capecitabine or pegylated liposomal doxorubicin (PLD', 'capecitabine or pegylated liposomal doxorubicin', 'Pyridoxine (B6', 'pyridoxine or placebo']","['ECOG status', 'PPE grade', 'Global Health Status', 'lower Fatigue', 'Pain', ""PPE grade, Quality of Life-QoL, Pain and patients' activities of daily living"", 'palmar-plantar erythrodysesthesia (PPE', 'worst PPE-associated QoL and higher PAIN levels', 'health related QoL, QoL-associated with PPE and pain levels', 'Social function', 'PPE-associated QoL and lower PAIN levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': '1-dodecylpyridoxal'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",30.0,0.22609,"Patients in the Intervention group experienced better Global Health Status (p = 0.012), Physical (p = 0.003), Emotional (p = 0.008), and Social function (p < 0.001), lower Fatigue (p = 0.001) and Pain (p = 0.006) compared to Control.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Charalambous', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus; University of Turku, Department of Nursing, Finland. Electronic address: andreas.charalambous@cut.ac.cy.'}, {'ForeName': 'Theologia', 'Initials': 'T', 'LastName': 'Tsitsi', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Astras', 'Affiliation': 'American Medical Center, 215, 2047, B22, Nicosia, Cyprus.'}, {'ForeName': 'Lefkios', 'Initials': 'L', 'LastName': 'Paikousis', 'Affiliation': 'Improvast, Arkadias 7, Fairdeal House, Flat 206, 1048, Nicosia, Cyprus.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Filippou', 'Affiliation': 'Cyprus University of Technology, Department of Nursing, 15 Vragadinou Street, 3041, Limassol, Cyprus.'}]",European journal of oncology nursing : the official journal of European Oncology Nursing Society,['10.1016/j.ejon.2020.101866']
1676,33228511,[Influence of Omega-3 PUFA on Non-invasive factors determining the risk of arrhYthmias eXcess and sudden cardiac death in patients with HFpEF with ischemic etiology (ONYX)].,"Aim Patients with heart failure with reduced left ventricular (LV) ejection fraction (HFrEF) who have had acute myocardial infarction have an unfavorable prognosis, largely due to ventricular arrhythmias (VA) and risk of sudden cardiac death (SCD). The optimal treatment (triple neurohormonal blockade plus implantable cardioverter defibrillator and cardiac resynchronization therapy) reduced the risk of SCD primarily due to reverse cardiac remodeling, but has not solved this problem completely. Efficacy of purified ω-3 polyunsaturated fatty acid esters (PUFA) in low doses (1 g/day) in reducing VA and risk of SCD in HFrEF patients was demonstrated in two large randomized clinical trials. The PUFA effects was suggested to be related also with increased heart rhythm variability (HRV) and chronotropic action, which might depend on the drug dose. The present open, prospective, randomized, comparative study in parallel groups evaluated the effect of Omacor in different doses on noninvasive markers of SCD risk in patients with ischemic HFrEF receiving the optimal drug therapy.Methods Patients (n=40) were randomized at a 1:1:2 ratio to the control group (n=10), the Omacor 1 g/day treatment group (n=10), and the Omacor 2 g/day treatment group (n=20) and were followed up for 12 months. Clinical evaluation included changes in the CHF functional class (FC) and Clinical Condition Scale (CCS) score; concentration of N-terminal pro-hormone brain natriuretic peptide (NT-proBNP); and peak oxygen consumption during exercise (peak VO2). The LV function was evaluated by LVEF. Holter ECG monitoring was used for evaluation of HRV (SDNN), average 24-h heart rate (HR), number of ventricular extrasystoles (VE) per hour and severity of VA, and presence of paired VE and VT runs.Results Improvement of CHF FC became significant only with the high-dose Omacor treatment (2 g/day). The CCS score showed a tendency towards decrease also with a lower dose (1 g/day) whereas the level of NT-proBNP significantly decreased with both Omacor doses. The increase in LV EF was significant only with the use of Omacor 2 g/day (+3 %, р=0.002). A negative chronotropic effect of ω-3 PUFA was observed. Average 24-h HR decreased by 8 bpm (р=0.05) and 11 bpm (р<0.001) with Omacor 1 g/day and 2 g/day, respectively. Either dose of ω-3 PUFA significantly improved VO2, which directly correlated with LV EF and inversely correlated with HR. The decrease in number of VE was associated not only with improved HRV (SDNN) but also with the decrease in 24-h HR, and thus Omacor 2 g/day significantly decreased the number of VE (by 16 per hour) and dangerous VA (paired VE and VT runs ceased to be detected in 40 % of patients).Conclusion Since HR, HRV, and VA are closely interrelated, the effect of ω-3 PUFA specifically on these noninvasive markers apparently determines its ability to decrease the risk of SCD in patients with ischemic HFrEF. The antiarrhythmic effect of Omacor was greater with higher doses of this drug.",2020,"Average 24-h HR decreased by 8 bpm (р=0.05) and 11 bpm (р<0.001) with Omacor 1 g/day and 2 g/day, respectively.","['Patients with heart failure with reduced left ventricular (LV) ejection fraction (HFrEF) who have had acute myocardial infarction', 'Methods Patients (n=40', 'HFrEF patients', 'patients with ischemic HFrEF', 'patients with HFpEF with ischemic etiology (ONYX', 'patients with ischemic HFrEF receiving the optimal drug therapy']","['Omega-3 PUFA', 'ω-3 PUFA', 'neurohormonal blockade plus implantable cardioverter defibrillator and cardiac resynchronization therapy', 'purified ω-3 polyunsaturated fatty acid esters (PUFA']","['CHF FC', 'Average 24-h HR', 'evaluation of HRV (SDNN), average 24-h heart rate (HR), number of ventricular extrasystoles (VE) per hour and severity of VA, and presence of paired VE and VT runs', 'LV EF', 'number of VE', 'LV function', 'VO2', 'VA and risk of SCD', 'heart rhythm variability (HRV) and chronotropic action', 'CHF functional class (FC) and Clinical Condition Scale (CCS) score; concentration of N-terminal pro-hormone brain natriuretic peptide (NT-proBNP); and peak oxygen consumption during exercise (peak VO2', 'level of NT-proBNP', 'improved HRV (SDNN']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",40.0,0.0468085,"Average 24-h HR decreased by 8 bpm (р=0.05) and 11 bpm (р<0.001) with Omacor 1 g/day and 2 g/day, respectively.","[{'ForeName': 'V Yu', 'Initials': 'VY', 'LastName': 'Mareev', 'Affiliation': 'Medical Research and Educational Center of the M. V. Lomonosov Moscow State University, Moscow, Russia Faculty of Fundamental Medicine, Lomonosov Moscow State University, Russia.'}, {'ForeName': 'Yu V', 'Initials': 'YV', 'LastName': 'Mareev', 'Affiliation': 'National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia Robertson Centre for Biostatistics, Glasgow, Great Britain.'}]",Kardiologiia,['10.18087/cardio.2020.10.n1327']
1677,32692071,Assessing the Quality of Rectal Cancer Pathology Reports in National Surgical Adjuvant Breast and Bowel Project Protocol R-04/NRG Oncology.,"BACKGROUND
Accurate and comprehensive surgical pathology reports are integral to the quality of cancer care. Despite guidelines from the College of American Pathologists, variations in reporting quality continue to exist.
OBJECTIVE
The aim of this study was to evaluate the quality of rectal cancer pathology reports and to identify areas of deficiency and potential sources of reporting variations.
DESIGN
This is a retrospective analysis of prospectively obtained pathology reports.
SETTING
This study is based at the hospitals participating in the National Surgical Adjuvant Breast and Bowel Project Protocol R-04 study.
PATIENTS
Patients with rectal cancer undergoing surgical resection between July 2004 and August 2010 were included.
MAIN OUTCOME MEASURES
The primary outcomes measured were the adherence to the College of American Pathologists guidelines and the impact of synoptic reporting, academic status, rural/urban setting, and hospital bed size on reporting quality.
RESULTS
We identified 1004 surgical pathology reports for rectal cancer surgery from 383 hospitals and 755 pathologists. The overall adherence rate to the College of American Pathologists guidelines was 73.3%. Notable reporting deficiencies were found in several key pathology characteristics, including tumor histologic grade (reporting rate 77.8%), radial margin (84.6%), distance from the closest margin (47.9%), treatment effect (47.1%), and lymphovascular (73.1%)/perineural invasions (35.4%). Synoptic reporting use and urban hospital settings were associated with better adherence rates, whereas academic status and hospital bed size had no impact. Reporting variations existed not only between institutions, but also within individual hospitals and pathologists. There was a trend for improved adherence over time (2005 = 65.7% vs 2010 = 82.3%, p < 0.001), which coincided with the increased adoption of synoptic reporting by pathologists (2005 vs 2010, 9.4% vs 25.3%, p < 0.001).
LIMITATIONS
Data were obtained from a restricted setting (ie, hospitals participating in a randomized clinical trial).
CONCLUSIONS
Wide variations in the quality of pathology reporting are observed for rectal cancer. The National Accreditation Program for Rectal Cancer mandates that programs meet strict quality standards for surgical pathology reporting. Further improvement is needed in this key aspect of oncology care for patients with rectal cancer. See Video Abstract at http://links.lww.com/DCR/B238.ClinicalTrials.gov registration: NCT00058 EVALUACIÓN DE LA CALIDAD DE LOS INFORMES DE PATOLOGÍA QUIRÚRGICA EN CASOS DE CÁNCER DE RECTO DEL NSABP R-04/ ONCOLOGÍA DEL NRG: Un informe de patología quirúrgica preciso y completo es fundamental en la calidad de atención de pacientes con cáncer. A pesar de las normas establecidas por el Colegio Americano de Patología, la variabilidad en la calidad de los informes es evidente.Evaluar la calidad de los informes de patología en casos de cáncer de recto para así identificar las áreas con deficiencias y las posibles fuentes variables en los mencionados informes.Análisis retrospectivo de informes de patología quirúrgica obtenidos prospectivamente.Hospitales que participan del Protocolo del Estudio Nacional R-04 como Adyuvantes Quirúrgicos de Mama e Intestino.Todos aquellos pacientes con cáncer de recto sometidos a resección quirúrgica entre Julio 2004 y Agosto 2010.Cumplimiento de las normas del Colegio Americano de Patología, del impacto de los informes sinópticos, del estado académico, del entorno rural / urbano y el número de camas hospitalarias en en la calidad de los informes.Identificamos 1,004 informes de patología quirúrgica en casos de cirugía en cáncer de recto en 383 hospitales y 755 patólogos. La tasa general de adherencia a las directivas del Colegio Americano de Patología fue del 73.3%. Se encontraron deficiencias notables en los informes en varias características patológicas clave incluidos, el grado histológico del tumor (tasa de informe 77.8%), margenes radiales (84.6%), distancia del margen más cercano (47.9%), efecto del tratamiento (47.1%) invasión linfovascular (73.1 %) / invasion perineural (35.4%). El uso de informes sinópticos y los entornos hospitalarios urbanos se asociaron con mejores tasas de adherencia, mientras que el estado académico y el número de camas hospitalarias no tuvieron ningún impacto. Hubo variaciones en los informes no solo entre instituciones, sino también dentro de hospitales y patólogos individuales. Hubo una tendencia a una mejor adherencia a lo largo del tiempo (2005 = 65.7% v 2010 = 82.3%, p < 0.001), que coincidió con la mayor adopción de informes sinópticos por parte de los patólogos (2005 v 2010, 9.4% v 25.3%, p < 0.001)Datos obtenidos de un entorno restringido (es decir, hospitales que participan en un ensayo clínico aleatorizado).Se observaron grandes variaciones en la calidad de los informes de patología quirúrgica en casos de cáncer de recto. El Programa Nacional de Acreditación para Cáncer de Recto exige que los programas cumplan con estrictos estándares de calidad para los informes de patología quirúrgica. Se necesita una mejoría adicional en este aspecto clave de la atención oncológica para pacientes con cáncer de recto. Video Resumen en http://links.lww.com/DCR/B238.Registro de Clinical Trials.gov: NCT00058.",2020,"There was a trend for improved adherence over time (2005 = 65.7% vs 2010 = 82.3%, p < 0.001), which coincided with the increased adoption of synoptic reporting by pathologists (2005 vs 2010, 9.4% vs 25.3%, p < 0.001).
","['Hubo una tendencia a una mejor adherencia', 'Patients with rectal cancer undergoing surgical resection between July 2004 and August 2010 were included', 'patients with rectal cancer', 'QUIRÚRGICA EN', '1004 surgical pathology reports for rectal cancer surgery from 383 hospitals and 755 pathologists', 'hospitals participating in the National Surgical Adjuvant Breast and Bowel Project Protocol R-04 study', 'hospitales que participan en un ensayo clínico aleatorizado).Se observaron grandes variaciones en']","['See Video Abstract at http://links.lww.com/DCR/B238.ClinicalTrials.gov registration', 'Evaluar la calidad', 'CASOS DE CÁNCER']","['tumor histologic grade', 'adherence rates', 'el estado académico', 'patología quirúrgica en casos de cirugía', 'adherence over time', 'adoption of synoptic reporting by pathologists', 'radial margin', 'adherence to the College of American Pathologists guidelines and the impact of synoptic reporting, academic status, rural/urban setting, and hospital bed size on reporting quality', 'que coincidió con la mayor adopción', 'overall adherence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030669', 'cui_str': 'Surgical Pathology'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0919553', 'cui_str': 'Histologic grade'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0019954', 'cui_str': 'Bed Capacities, Hospital'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0272938,"There was a trend for improved adherence over time (2005 = 65.7% vs 2010 = 82.3%, p < 0.001), which coincided with the increased adoption of synoptic reporting by pathologists (2005 vs 2010, 9.4% vs 25.3%, p < 0.001).
","[{'ForeName': 'Shonan', 'Initials': 'S', 'LastName': 'Sho', 'Affiliation': '1 Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California 2 NRG Oncology, Pittsburgh, Pennsylvania 3 The University of Pittsburgh, Pittsburgh, Pennsylvania 4 Department of Health Policy & Management, Fielding School of Public Health and the Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 5 Glendale Memorial Hospital and Health Center, Glendale, California 6 Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Yothers', 'Affiliation': ''}, {'ForeName': 'Linda H', 'Initials': 'LH', 'LastName': 'Colangelo', 'Affiliation': ''}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Ganz', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': ""O'Connell"", 'Affiliation': ''}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Beart', 'Affiliation': ''}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Hemmelgarn', 'Affiliation': ''}, {'ForeName': 'Formosa C', 'Initials': 'FC', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Clifford Y', 'Initials': 'CY', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Russell', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001578']
1678,32692124,Cognitive Remediation for Outpatients With Recurrent Mood Disorders: A Feasibility Study.,"Current first-line treatments for mood disorders often improve mood symptoms but do little to reduce cognitive and functional impairment. This 10-week, uncontrolled, feasibility study evaluated a cognitive remediation (CR) intervention for individuals with recurrent mood disorders. Adults with recurrent major depressive disorder or bipolar disorder, who had recently been treated and discharged from specialized mental health services, were eligible for inclusion. Twenty patients completed the CR intervention, which involved weekly individual sessions with a therapist, as well as the practice of computerized CR exercises between sessions. The study assessed the acceptability of the assessment and treatment as well as outcomes in terms of mood symptoms, general functioning, and cognitive functioning. Patients reported that they were generally satisfied with the CR intervention and were close to reaching the recommended amount of practice between therapist-led sessions. The retention rate from baseline to posttreatment was 87%. When within-group effects were examined, large effect sizes over time (>0.9) were seen for 2 cognitive variables that measured executive function: Category Switching-Total Words and Total Switching Score. Findings from the current feasibility study will inform the development of a large randomized controlled trial of an adapted version of the CR intervention for mood disorders assessed in this preliminary study, with the goal of translating the intervention into clinical practice.",2020,"When within-group effects were examined, large effect sizes over time (>0.9) were seen for 2 cognitive variables that measured executive function: Category Switching-Total Words and Total Switching Score.","['individuals with recurrent mood disorders', 'Twenty patients completed the', 'Outpatients', 'Adults with recurrent major depressive disorder or bipolar disorder, who had recently been treated and discharged from specialized mental health services, were eligible for inclusion', 'With Recurrent Mood Disorders']","['cognitive remediation (CR) intervention', 'CR intervention']","['executive function: Category Switching-Total Words and Total Switching Score', 'retention rate', 'Cognitive Remediation', 'mood symptoms, general functioning, and cognitive functioning']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0344902,"When within-group effects were examined, large effect sizes over time (>0.9) were seen for 2 cognitive variables that measured executive function: Category Switching-Total Words and Total Switching Score.","[{'ForeName': 'Katie M', 'Initials': 'KM', 'LastName': 'Douglas', 'Affiliation': ""DOUGLAS, JORDAN, INDER, CROWE: Department of Psychological Medicine, University of Otago, Christchurch, New Zealand MULDER, BEAGLEHOLE, PORTER: Department of Psychological Medicine, University of Otago, and Specialist Mental Health Services, Canterbury District Health Board, Christchurch, New Zealand LACEY: Department of Psychological Medicine, University of Otago, Christchurch, New Zealand, and West Coast District Health Board, Greymouth, New Zealand BOWIE: Department of Psychology, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': ''}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Inder', 'Affiliation': ''}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Crowe', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Mulder', 'Affiliation': ''}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Lacey', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Beaglehole', 'Affiliation': ''}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ''}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Porter', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000487']
1679,32693185,"Efficacy and Safety of Tradipitant in Patients With Diabetic and Idiopathic Gastroparesis in a Randomized, Placebo-Controlled Trial.","BACKGROUND & AIMS
Treatments are needed for gastroparesis; antagonists of tachykinin receptor 1 (TACR1, also called NK1R) can reduce symptoms of nausea and vomiting. We investigated the safety and efficacy of tradipitant, an antagonist of NK1R, in patients with idiopathic or diabetic gastroparesis.
METHODS
We performed a double-blind trial of 152 adults with gastroparesis at 47 sites in the United States from November 2016 through December 2018. Participants were randomly assigned to groups given oral tradipitant 85 mg (n = 77) or placebo (n = 75) twice daily for 4 weeks. Symptoms were assessed by a daily symptom dairy, Gastroparesis Cardinal Symptom Index scores, and other patient-reported questionnaires. The primary outcome from the intent-to-treat analysis was change from baseline to week 4 in average nausea severity, measured by the Gastroparesis Core Symptom Daily Diary.
RESULTS
Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P = .0099) and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; P = .0160). Patients with nausea and vomiting at baseline (n = 101) had an even greater decrease in nausea in when given tradipitant (reduction of 1.4) compared with those given placebo (reduction of 0.4) (P < .0001), as well as an increase in nausea-free days at week 4 (32.3% improvement on tradipitant vs 7.6% on placebo; P = .0003). The average nausea score was 1 or less at week 4 in 32.9% of patients given tradipitant compared with 11.8% of patients given placebo (P = .0013). A greater than 1-point improvement in Gastroparesis Cardinal Symptom Index score was observed in 46.6% of patients given tradipitant compared with 23.5% of patients given placebo (P = .0053).
CONCLUSIONS
Tradipitant resulted in statistically and clinically meaningful improvements in nausea and reduced vomiting, compared with placebo, in patients with idiopathic or diabetic gastroparesis. ClinicalTrials.gov, Number: NCT02970968.",2020,"RESULTS
Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P=.0099), and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; P=.0160).","['patients with idiopathic or diabetic gastroparesis', 'Patients with Diabetic and Idiopathic Gastroparesis', '152 adults with gastroparesis at 47 sites in the United States from November 2016 through December 2018']","['oral tradipitant', 'Tradipitant', 'Placebo', 'placebo']","['Efficacy and Safety', 'nausea-free days', 'gastroparesis cardinal symptom index score', 'daily symptom dairy, gastroparesis cardinal symptom index scores', 'Average nausea score', 'nausea and vomiting', 'nausea and reduced vomiting', 'average nausea severity, measured by the gastroparesis core symptom daily diary', 'safety and efficacy', 'nausea', 'nausea score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis with diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0859972', 'cui_str': 'Idiopathic gastroparesis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",152.0,0.491972,"RESULTS
Patients receiving tradipitant had a significant decrease in nausea score (reduction of 1.2) at week 4 compared with placebo (reduction of 0.7) (P=.0099), and a significant increase in of nausea-free days at week 4 (28.8% increase on tradipitant vs 15.0% on placebo; P=.0160).","[{'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Carlin', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC. Electronic address: Jesse.Carlin@vandapharma.com.'}, {'ForeName': 'V Rose', 'Initials': 'VR', 'LastName': 'Lieberman', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Arya', 'Initials': 'A', 'LastName': 'Dahal', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Madison S', 'Initials': 'MS', 'LastName': 'Keefe', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Xiao', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Gunther', 'Initials': 'G', 'LastName': 'Birznieks', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Abell', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Henry P', 'Initials': 'HP', 'LastName': 'Parkman', 'Affiliation': 'Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Mihael H', 'Initials': 'MH', 'LastName': 'Polymeropoulos', 'Affiliation': 'Vanda Pharmaceuticals, Inc, Washington, DC.'}]",Gastroenterology,['10.1053/j.gastro.2020.07.029']
1680,32702699,Brain Imaging Signs and Health-Related Quality of Life after Acute Ischemic Stroke: Analysis of ENCHANTED Alteplase Dose Arm.,"BACKGROUND AND PURPOSE
The influence of specific brain lesions on health-related quality of life (HRQoL) after acute ischemic stroke (AIS) is uncertain. We aimed to identify imaging predictors of poor HRQoL in alteplase-treated participants of the alteplase dose arm of the Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).
METHODS
ENCHANTED was an international trial of low- versus standard-dose intravenous alteplase in AIS patients, with functional outcome (modified Rankin scale [mRS]) and HRQoL on the 5-dimension European Quality of Life Scale (EQ-5D) assessed at 90 days post-randomization. Brain images were analyzed centrally by trained assessors. Multivariable logistic regression was undertaken in the study population randomly divided (2:1) into training (development) and validation (performance) groups, with age (per 10-year increase), ethnicity, baseline National Institutes of Health Stroke Scale (NIHSS) score, diabetes mellitus, premorbid function (mRS score 0 or 1), and proxy respondent, forced into all models. Data are presented with odds ratios (ORs) and 95% confidence intervals (CIs).
RESULTS
Eight prediction models were developed and validated in 2,526 AIS patients (median age 67.5 years; 38.4% female; 61.7% Asian) with complete brain imaging and 90-day EQ-5D utility score data. The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions. Several background features of brain frailty - atrophy, white matter change, and old infarcts - were significantly associated with adverse physical but not emotional HRQoL domains.
CONCLUSIONS
In thrombolysed AIS patients, right-sided and deep ischemia within the MCA territory predict poor overall HRQoL, whilst features of old cerebral ischemia are associated with reduced physical HRQoL.",2020,"The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions.","['2,526 AIS patients (median age 67.5 years; 38.4% female; 61.7% Asian) with', 'after Acute Ischemic Stroke']",['low- versus standard-dose intravenous alteplase'],"['health-related quality of life (HRQoL', 'right-sided and deep ischemia', 'Health Stroke Scale (NIHSS', 'score, diabetes mellitus', 'functional outcome (modified Rankin scale [mRS]) and HRQoL on the 5-dimension European Quality of Life Scale (EQ-5D', 'physical HRQoL', 'complete brain imaging and 90-day EQ-5D utility score data', 'acute ischemic changes', 'Brain Imaging Signs and Health-Related Quality of Life', 'premorbid function (mRS score 0 or 1), and proxy respondent']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]",2526.0,0.097416,"The best performance model included acute ischemic changes in the right (OR 1.69, 95% CI: 1.24-2.29) and deep (OR 1.50, 95% CI: 1.03-2.19) middle cerebral artery (MCA) regions.","[{'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Delcourt', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Lingli', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'The George Institute China at Peking University Health Science Centre, Beijing, China.'}, {'ForeName': 'Zien', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sohei', 'Initials': 'S', 'LastName': 'Yoshimura', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Shoujiang', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Malavera', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Takako', 'Initials': 'T', 'LastName': 'Torii-Yoshimura', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Carcel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Hisatomi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': 'Department of Preventive Medicine and Public Health, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'Maree L', 'Initials': 'ML', 'LastName': 'Hackett', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Thompson', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chalmers', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Camperdown, New South Wales, Australia, canderson@george.org.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000509226']
1681,32706933,Effects of a Community-Based Multicomponent Positive Psychology Intervention on Mental Health of Rural Adults in Ghana.,"BACKGROUND
There is growing evidence that positive psychology interventions (PPIs) enhance positive mental health and lead to a decrease in symptoms of psychopathology. This study examines the effectiveness of a 10-week multicomponent PPI (the Inspired Life Program; ILP) in promoting positive mental health and reducing symptoms of depression and negative affect in a sample of rural poor adults in Ghana.
METHODS
Using a quasi-randomized controlled trial design, participants from four rural poor communities were randomly allocated to intervention (n = 40) or control (n = 42) conditions. The intervention group participated in the 10-week ILP. Both groups completed a battery of mental health measures, including the Mental Health Continuum-Short Form, at pre-intervention, immediately after the intervention, and at 3 months follow-up. Hierarchical linear modeling was applied to evaluate whether the intervention was effective.
RESULTS
There was a greater improvement in positive mental health, with a marked reduction in symptoms of depression in the intervention group compared to the control group, immediately and 3 months after the intervention. There were also larger increases in the proportion of flourishers in the intervention group compared to the control group, immediately and three months after the intervention.
CONCLUSIONS
The observed effects of the ILP intervention program suggest that group-based PPIs can promote positive mental health and buffer against psychopathology among people living in rural poor communities in sub-Saharan Africa.",2020,"Both groups completed a battery of mental health measures, including the Mental Health Continuum-Short Form, at pre-intervention, immediately after the intervention, and at 3 months follow-up.","['rural poor adults in Ghana', 'participants from four rural poor communities', 'people living in rural poor communities in sub-Saharan Africa', 'Mental Health of Rural Adults in Ghana']","['multicomponent PPI (the Inspired Life Program; ILP', 'positive psychology interventions (PPIs', 'Community-Based Multicomponent Positive Psychology Intervention']","['symptoms of depression', 'proportion of flourishers', 'positive mental health']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0017516', 'cui_str': 'Ghana'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",4.0,0.0677002,"Both groups completed a battery of mental health measures, including the Mental Health Continuum-Short Form, at pre-intervention, immediately after the intervention, and at 3 months follow-up.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Appiah', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Wilson-Fadiji', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Lusilda', 'Initials': 'L', 'LastName': 'Schutte', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Marié P', 'Initials': 'MP', 'LastName': 'Wissing', 'Affiliation': 'Africa Unit for Transdisciplinary Health Research, North-West University, Potchefstroom, South Africa.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12212']
1682,32706953,Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.,"BACKGROUND
Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.
METHODS
We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.
RESULTS
A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P = 1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P = 1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
CONCLUSIONS
Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).",2020,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","['hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen', 'Mild-to-Moderate Covid-19', 'patients with coronavirus disease 2019 (Covid-19', 'patients hospitalized with mild-to-moderate Covid-19', '667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis']","['Hydroxychloroquine and azithromycin', 'hydroxychloroquine', 'hydroxychloroquine plus azithromycin', 'Hydroxychloroquine with or without Azithromycin', 'azithromycin', 'standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine']","['safety and efficacy', 'Safety', 'Prolongation of the corrected QT interval and elevation of liver-enzyme levels', 'clinical status at 15 days as assessed with the use of a seven-level ordinal scale']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C4517851', 'cui_str': '667'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",667.0,0.251782,"Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.
","[{'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Regis G', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Luciano C P', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Marcadenti', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Letícia', 'Initials': 'L', 'LastName': 'Kawano-Dourado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Lisboa', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Debora L M', 'Initials': 'DLM', 'LastName': 'Junqueira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Pedro G M', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Tramujas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Erlon O', 'Initials': 'EO', 'LastName': 'Abreu-Silva', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ligia N', 'Initials': 'LN', 'LastName': 'Laranjeira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Aline T', 'Initials': 'AT', 'LastName': 'Soares', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Leandro S', 'Initials': 'LS', 'LastName': 'Echenique', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adriano J', 'Initials': 'AJ', 'LastName': 'Pereira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávio G R', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otávio C E', 'Initials': 'OCE', 'LastName': 'Gebara', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Vicente C S', 'Initials': 'VCS', 'LastName': 'Dantas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Remo H M', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Eveline P', 'Initials': 'EP', 'LastName': 'Milan', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Golin', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Fábio F', 'Initials': 'FF', 'LastName': 'Cardoso', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Israel S', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Conrado R', 'Initials': 'CR', 'LastName': 'Hoffmann Filho', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Adrian P M', 'Initials': 'APM', 'LastName': 'Kormann', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Roberto B', 'Initials': 'RB', 'LastName': 'Amazonas', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Monalisa F', 'Initials': 'MF', 'LastName': 'Bocchi de Oliveira', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa-Neto', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Maicon', 'Initials': 'M', 'LastName': 'Falavigna', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Flávia R', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'From HCor Research Institute (A.B.C., F.G.Z., L.P.D., A.M., L.K.-D., T.L., D.L.M.J., P.G.M.B.S., L.T., E.O.A.-S., L.N.L., I.S.M.), Brazilian Research in Intensive Care Network (A.B.C., F.G.Z., R.G.R., L.C.P.A., V.C.V., T.L., F.G.R.F., A.S.-N., F.R.M.), Hospital Sírio Libanês Research and Education Institute (L.C.P.A.), BP-A Beneficência Portuguesa de São Paulo (V.C.V.), International Research Center, Hospital Alemão Oswaldo Cruz (A.A.), Brazilian Clinical Research Institute (P.G.M.B.S., R.D.L.), Hospital São Camilo (A.T.S.), Hospital Moriah (L.S.E.), Academic Research Organization of Hospital Israelita Albert Einstein (R.H.M.F., O.B.), Hospital Israelita Albert Einstein (L.S.E., A.J.P., A.S.-N.), Hospital Sepaco (F.G.R.F.), and Hospital Santa Paula (O.C.E.G.), São Paulo, Hospital Moinhos de Vento, Porto Alegre (R.G.R., M.F.), Hospital Naval Marcílio Dias, Rio de Janeiro (V.C.S.D.), Hospital Giselda Trigueiro, Natal (E.P.M.), Instituto Tacchini de Pesquisa em Saúde, Hospital Tacchini, Bento Gonçalves (N.A.G.), Hospital Bruno Born, Lajeado (F.F.C.), Hospital Baia Sul, Florianópolis (I.S.M.), Hospital Regional Hans Dieter Schmidt, Joinville (C.R.H.F.); Angiocor Blumenau, Blumenau (A.P.M.K.), and EMS Pharma, Hortolândia (R.B.A., M.F.B.O.) - all in Brazil; and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (R.D.L.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2019014']
1683,32696120,Effectiveness of an Educational Video in Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age: A Cluster Randomized Controlled Trial.,"This study aimed to investigate whether watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduces self-reported shaking and smothering, at a 1-month health checkup. A cluster randomized controlled trial, stratified by area and hospital function, was employed in 45 obstetrics hospitals/clinics in Osaka Prefecture, Japan. In the intervention group, mothers watched an educational video on infant crying and the dangers of shaking and smothering an infant, within 1 week of age, during hospitalization at maternity wards, without blinding on group allocation. Control group received usual care. A total of 4722 (N = 2350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age < 22 weeks were excluded) between October 1, 2014, and January 31 were recruited. Outcomes were self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup. In all, 2718 (N = 1078 and 1640) responded to the questionnaire (response rate: 58.3%), and analytic sample size was 2655 (N = 1058 and 1597 for intervention and control group, respectively). Multilevel analysis was used to adjust for correlation within the cluster. Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%). Intention-to-treat analysis showed an 89% reduction in the reported prevalence of self-reported shaking (OR: 0.11, 95% CI: 0.02-0.53) due to watching the educational video. However, self-reported smothering behavior showed no significant reduction (OR: 0.66, 95% CI: 0.27-1.60). No side effects were reported. Watching an educational video on infant crying and the dangers of shaking and smothering within 1 week after delivery at maternity wards reduced self-reported shaking at 1 month of age. UMIN Clinical Trial Registry UMIN000015558.",2020,Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%).,"['45 obstetrics hospitals/clinics in Osaka Prefecture, Japan', 'Maternity Wards to Prevent Self-Reported Shaking and Smothering during the First Week of Age', 'A total of 4722 (N\u2009=\u20092350 and 2372 for intervention and control group, respectively) mothers who delivered their babies (still birth and gestational age\u2009<\u200922\xa0weeks were excluded) between October 1, 2014, and January 31 were recruited']","['mothers watched an educational video', 'usual care', 'Educational Video', 'watching an educational video', 'Watching an educational video']","['Prevalence of shaking', 'self-reported shaking and smothering behaviors, knowledge on infant crying and shaking, and behaviors to cope with infant crying, assessed via a questionnaire at a 1-month health checkup']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C0277619', 'cui_str': 'Traumatic asphyxiation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0040822', 'cui_str': 'Tremor'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0277619', 'cui_str': 'Traumatic asphyxiation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}]",4722.0,0.0869133,Prevalence of shaking was significantly lower in the intervention group (0.19%) than in the control group (1.69%).,"[{'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. fujiwara.hlth@tmd.ac.jp.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Isumi', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Sampei', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Systems and Control Engineering, Tokyo Institute of Technology, Tokyo, Japan.'}, {'ForeName': 'Fujiko', 'Initials': 'F', 'LastName': 'Yamada', 'Affiliation': 'Department of Global Health Promotion, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Noma', 'Affiliation': 'Department of Data Science, The Institute of Statistical Mathematics, Tokyo, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Ogita', 'Affiliation': 'Department of Obstetrics and Gynecology, Rinku General Medical Center, Osaka, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Mitsuda', 'Affiliation': 'Department of Obstetrics, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01145-z']
1684,32696603,Differential Effects of High- and Low-Arousal Positive Emotions on Help-Seeking for Depression.,"BACKGROUND
The current set of pre-registered studies tested the effect of savoring a high-arousal (exciting) or low-arousal (calm) positive experience on help-seeking intentions among people with heightened depressive symptomatology.
METHODS
Across all three studies, participants with heightened depressive symptomatology who had not yet sought help were randomly assigned to complete a 6-minute writing task where they reflected on an exciting memory, a calm memory, or what they did today and yesterday.
RESULTS
Savoring an exciting memory was associated with significantly greater arousal than savoring a calm memory and the control condition (Study 1; N = 218). Both savoring conditions were associated with greater positive emotion than the control condition (Study 2; N = 193). In Study 3 (N = 1,238), savoring an exciting memory, when compared to the control condition, increased help-seeking intentions, whereas savoring a calm memory did not.
CONCLUSIONS
The current studies support the use of high-arousal, rather than low-arousal, positive emotions to increase help-seeking intentions among people with depression.",2020,"In Study 3 (N = 1,238), savoring an exciting memory, when compared to the control condition, increased help-seeking intentions, whereas savoring a calm memory did not.
","['participants with heightened depressive symptomatology who had not yet sought help', 'people with heightened depressive symptomatology', 'people with depression']","['High- and Low-Arousal Positive Emotions', 'savoring a high-arousal (exciting) or low-arousal (calm) positive experience']","['positive emotion', 'help-seeking intentions']","[{'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.14009,"In Study 3 (N = 1,238), savoring an exciting memory, when compared to the control condition, increased help-seeking intentions, whereas savoring a calm memory did not.
","[{'ForeName': 'Tasha', 'Initials': 'T', 'LastName': 'Straszewski', 'Affiliation': 'Claremont Graduate University, Claremont, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Siegel', 'Affiliation': 'Claremont Graduate University, Claremont, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12214']
1685,32697335,A quality-adjusted survival time without symptoms or toxicities analysis of glasdegib plus low-dose cytarabine versus low-dose cytarabine as initial therapy for acute myeloid leukemia in patients who are not considered candidates for intensive chemotherapy.,"BACKGROUND
In a randomized study, glasdegib (a hedgehog inhibitor) plus low-dose cytarabine (LDAC) significantly prolonged survival in comparison with LDAC in patients with acute myeloid leukemia (AML). A quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST) approach was used to evaluate comparative quality-adjusted survival.
METHODS
Overall survival was partitioned into the following: time with any treatment-emergent grade 3 or higher adverse events (TOX); time without symptoms of disease progression or toxicity (TWiST); and time after treatment discontinuation due to insufficient clinical response, relapse, or death time after progression (REL). Q-TWiST was calculated by multiplying the restricted mean time in each state by respective utilities and then summing up the utility-adjusted time.
RESULTS
At 20 months of follow-up, the survival probabilities for the glasdegib-LDAC arm and the LDAC arm were 28.2% and 7.9%, respectively. Glasdegib-LDAC patients (n = 78), in comparison with LDAC patients (n = 38), had significantly longer mean TWiST (+3.4 months; 95% confidence interval [CI], 1.8-5.2 months) and TOX (+0.8 months; 95% CI, 0.1-1.6 months) and longer but nonsignificant REL (+0.3 months; 95% CI, -1.9 to 2.3 months). Q-TWiST was 4.0 months (95% CI, 2.1-5.8 months) longer with glasdegib plus LDAC, and this translated into a 75% relative improvement in quality-adjusted survival with respect to LDAC. Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included.
CONCLUSIONS
These results suggest that most of the survival benefit from glasdegib plus LDAC versus LDAC alone is TWiST, and this represents added time in relatively ""good"" health. These results support the clinical value of glasdegib plus LDAC as initial therapy for AML in patients for whom intensive chemotherapy is not an option.",2020,"Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included.
","['acute myeloid leukemia in patients who are not considered candidates for intensive chemotherapy', 'patients with acute myeloid leukemia (AML']","['cytarabine', 'glasdegib (a hedgehog inhibitor) plus low-dose cytarabine (LDAC', 'LDAC', 'glasdegib plus low-dose cytarabine']","['comparative quality-adjusted survival', 'survival probabilities', 'adverse events (TOX); time without symptoms of disease progression or toxicity (TWiST); and time after treatment discontinuation due to insufficient clinical response, relapse, or death time after progression (REL', 'TOX', 'quality-adjusted survival', 'longer mean TWiST']","[{'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0018866', 'cui_str': 'Erinaceidae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1301931', 'cui_str': 'Time of death'}, {'cui': 'C0040541', 'cui_str': 'Toxicology'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.107607,"Results were robust to the length of follow-up (6-24 months) and remained significant when all adverse events, regardless of grade, were included.
","[{'ForeName': 'Caitlyn T', 'Initials': 'CT', 'LastName': 'Solem', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Bell', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Youngmin', 'Initials': 'Y', 'LastName': 'Kwon', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cappelleri', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bhattacharyya', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Hoang', 'Affiliation': 'Pfizer, Inc, New York, New York.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Pharmerit - an OPEN Health Company, Bethesda.'}]",Cancer,['10.1002/cncr.33072']
1686,32703182,Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection for rectal cancer: study protocol of a randomised controlled multicentre trial (BIOPEX-2 study).,"BACKGROUND
Abdominoperineal resection (APR) for rectal cancer is associated with high morbidity of the perineal wound, and controversy exists about the optimal closure technique. Primary perineal wound closure is still the standard of care in the Netherlands. Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study). It is suggested, based on meta-analysis of cohort studies, that filling of the perineal defect with well-vascularised tissue improves perineal wound healing. A gluteal turnover flap seems to be a promising method for this purpose, and with the advantage of not having a donor site scar. The aim of this study is to investigate whether a gluteal turnover flap improves the uncomplicated perineal wound healing after APR for rectal cancer.
METHODS
Patients with primary or recurrent rectal cancer who are planned for APR will be considered eligible in this multicentre randomised controlled trial. Exclusion criteria are total exenteration, sacral resection above S4/S5, intersphincteric APR, biological mesh closure of the pelvic floor, collagen disorders, and severe systemic diseases. A total of 160 patients will be randomised between gluteal turnover flap (experimental arm) and primary closure (control arm). The total follow-up duration is 12 months, and outcome assessors and patients will be blinded for type of perineal wound closure. The primary outcome is the percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less than two. Secondary outcomes include time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function.
DISCUSSION
The uncomplicated perineal wound healing rate is expected to increase from 65 to 85% by using the gluteal turnover flap. With proven effectiveness, a quick implementation of this relatively simple surgical technique is expected to take place.
TRIAL REGISTRATION
The trial was retrospectively registered at Clinicaltrials.gov NCT04004650 on July 2, 2019.",2020,Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study).,"['Patients with primary or recurrent rectal cancer who are planned for', 'rectal cancer', '160 patients']","['Perineal wound closure using gluteal turnover flap or primary closure after abdominoperineal resection', 'Abdominoperineal resection (APR', 'Biological mesh closure', 'gluteal turnover flap (experimental arm) and primary closure (control arm', 'gluteal turnover flap', 'APR']","['uncomplicated perineal wound healing rate', 'time to perineal wound closure, incidence of perineal hernia, the number, duration and nature of the complications, re-interventions, quality of life and urogenital function', 'wound healing', 'percentage of uncomplicated perineal wound healing on day 30, defined as a Southampton wound score of less']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0278554', 'cui_str': 'Rectal cancer recurrent'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019305', 'cui_str': 'Perineal hernia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0579062', 'cui_str': 'Urogenital function'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",160.0,0.151325,Biological mesh closure did not improve wound healing in our previous randomised controlled trial (BIOPEX-study).,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sharabiany', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands. s.sharabiany@amsterdamumc.nl.'}, {'ForeName': 'Robin D', 'Initials': 'RD', 'LastName': 'Blok', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Oren', 'Initials': 'O', 'LastName': 'Lapid', 'Affiliation': 'Department of Plastic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Hompes', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wilhelmus A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Victor P', 'Initials': 'VP', 'LastName': 'Alberts', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Lamme', 'Affiliation': 'Department of Surgery, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Wijsman', 'Affiliation': 'Department of Surgery, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Jurriaan B', 'Initials': 'JB', 'LastName': 'Tuynman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, Free University, Amsterdam, The Netherlands.'}, {'ForeName': 'Arend G J', 'Initials': 'AGJ', 'LastName': 'Aalbers', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Geerard L', 'Initials': 'GL', 'LastName': 'Beets', 'Affiliation': 'Department of Surgery, Antoni van Leeuwenhoek Hospital-Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Hans F J', 'Initials': 'HFJ', 'LastName': 'Fabry', 'Affiliation': 'Department of Surgery, Bravis Hospital, Roosendaal, The Netherlands.'}, {'ForeName': 'Ivan M', 'Initials': 'IM', 'LastName': 'Cherepanin', 'Affiliation': 'Department of Surgery, Bravis Hospital, Roosendaal, The Netherlands.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Polat', 'Affiliation': 'Department of Surgery, Canisius Wilhelmina Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'Jacobus W A', 'Initials': 'JWA', 'LastName': 'Burger', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Harm J T', 'Initials': 'HJT', 'LastName': 'Rutten', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Robert J I', 'Initials': 'RJI', 'LastName': 'Bosker', 'Affiliation': 'Department of Surgery, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Talsma', 'Affiliation': 'Department of Surgery, Deventer Hospital, Deventer, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Rothbarth', 'Affiliation': 'Department of Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Cees', 'Initials': 'C', 'LastName': 'Verhoef', 'Affiliation': 'Department of Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anthony W H', 'Initials': 'AWH', 'LastName': 'van de Ven', 'Affiliation': 'Department of Surgery, Flevo Hospital, Almere, The Netherlands.'}, {'ForeName': 'Jarmila D W', 'Initials': 'JDW', 'LastName': 'van der Bilt', 'Affiliation': 'Department of Surgery, Flevo Hospital, Almere, The Netherlands.'}, {'ForeName': 'Eelco J R', 'Initials': 'EJR', 'LastName': 'de Graaf', 'Affiliation': 'Department of Surgery, IJsselland Hospital, Capelle aan den Ijssel, The Netherlands.'}, {'ForeName': 'Pascal G', 'Initials': 'PG', 'LastName': 'Doornebosch', 'Affiliation': 'Department of Surgery, IJsselland Hospital, Capelle aan den Ijssel, The Netherlands.'}, {'ForeName': 'Jeroen W A', 'Initials': 'JWA', 'LastName': 'Leijtens', 'Affiliation': 'Department of Surgery, Laurentius Hospital, Roermond, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Heemskerk', 'Affiliation': 'Department of Surgery, Laurentius Hospital, Roermond, The Netherlands.'}, {'ForeName': 'Baljit', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Leicester Hospital, Leicester, UK.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Chaudhri', 'Affiliation': 'Department of Surgery, Leicester Hospital, Leicester, UK.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Gerhards', 'Affiliation': 'Department of Surgery, OLVG Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Karsten', 'Affiliation': 'Department of Surgery, OLVG Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes H W', 'Initials': 'JHW', 'LastName': 'de Wilt', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Andre J A', 'Initials': 'AJA', 'LastName': 'Bremers', 'Affiliation': 'Department of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Ronald J C L M', 'Initials': 'RJCLM', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Gijsbert', 'Initials': 'G', 'LastName': 'Heuff', 'Affiliation': 'Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands.'}, {'ForeName': 'Anna A W', 'Initials': 'AAW', 'LastName': 'van Geloven', 'Affiliation': 'Department of Surgery, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Tanis', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Gijsbert D', 'Initials': 'GD', 'LastName': 'Musters', 'Affiliation': 'Department of Surgery, Amsterdam UMC, Cancer Centre Amsterdam, University of Amsterdam, Amsterdam, The Netherlands.'}]",BMC surgery,['10.1186/s12893-020-00823-7']
1687,32708741,Locally Applied Slow-Release of Minocycline Microspheres in the Treatment of Peri-Implant Mucositis: An Experimental In Vivo Study.,"BACKGROUND
The objective of this is preclinical investigation was to evaluate the differential drug sustainability and pharmacodynamic properties of two local minocycline microsphere carriers: chitosan-coated alginate (CA) and poly(meth)acrylate-glycerin (PG).
METHODS
Four dental implants were placed unilaterally in the edentulous mandible of six beagle dogs. Each implant was randomly assigned to receive one of the following four treatments: (i) CA (CA-based minocycline), (ii) placebo (CA substrate without minocycline), (iii) PG (PG-based minocycline) and (iv) control (mechanical debridement only). After inducing peri-implant mucositis, the randomly assigned treatments were administered into the gingival sulcus twice at a 4-week interval using a plastic-tipped syringe. Drug sustainability and pharmacodynamic (clinical, radiographical and cell marker intensity) evaluations were performed after each administration.
RESULTS
The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days). The efficacy of the applied therapies based on clinical, radiographical and histological analyses were comparable across all treatment groups.
CONCLUSIONS
CA microspheres showed longer carrier and bacteriostatic effect sustainability when compared to PG microspheres, however, longer drug sustainability did not lead to improved treatment outcomes.",2020,The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days).,"['Peri-Implant Mucositis', 'Four dental implants were placed unilaterally in the edentulous mandible of six beagle dogs']","['Minocycline Microspheres', 'CA microspheres', 'CA (CA-based minocycline), (ii) placebo (CA substrate without minocycline), (iii) PG (PG-based minocycline) and (iv) control (mechanical debridement only', 'minocycline microsphere carriers: chitosan-coated alginate (CA) and poly(meth)acrylate-glycerin (PG']","['longer carrier and bacteriostatic effect sustainability', 'bacteriostatic effect', 'Drug sustainability and pharmacodynamic (clinical, radiographical and cell marker intensity) evaluations', 'CA microspheres']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0324306', 'cui_str': 'Beagle'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}]","[{'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0597265', 'cui_str': 'polyacrylate'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0162969', 'cui_str': 'Chitosan'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1611701', 'cui_str': 'Cell marker'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0026032', 'cui_str': 'Microbeads'}]",,0.0567987,The CA microspheres remained longer around the healing abutment compared to the PG microspheres at both administrations and a longer bacteriostatic effect was observed from CA (7.0 ± 5.7 days) compared to PG (1.2 ± 2.6 days).,"[{'ForeName': 'Sung-Wook', 'Initials': 'SW', 'LastName': 'Yoon', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Myong-Ji', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Kyeong-Won', 'Initials': 'KW', 'LastName': 'Paeng', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Kyeong Ae', 'Initials': 'KA', 'LastName': 'Yu', 'Affiliation': 'College of Pharmacy, Chungbuk National University, Cheongju 28165, Korea.'}, {'ForeName': 'Chong-Kil', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'College of Pharmacy, Chungbuk National University, Cheongju 28165, Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Jae-Kook', 'Initials': 'JK', 'LastName': 'Cha', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'Section of Graduate Periodontology, Faculty of Odontology, Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Ui-Won', 'Initials': 'UW', 'LastName': 'Jung', 'Affiliation': 'Department of Periodontology, Research Institute for Periodontal Regeneration, Yonsei University College of Dentistry, Seoul 03772, Korea.'}]",Pharmaceutics,['10.3390/pharmaceutics12070668']
1688,32710493,"Long-Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials.","OBJECTIVE
Psoriatic arthritis (PsA) requires long-term treatment, yet safety concerns and monitoring requirements make maintenance a challenge. This analysis of pooled Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) 1, 2, and 3 data describes 3-year apremilast safety and tolerability in PsA.
METHODS
Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily. Placebo patients were re-randomized to apremilast 30 mg twice daily or 20 mg twice daily at week 16 (early escape) or 24. Double-blind treatment continued to week 52; patients could continue apremilast during an open-label, long-term treatment phase.
RESULTS
In total, 1493 patients received at least one dose of study medication and were included in the safety population (placebo: n = 495; apremilast 30 mg: n = 497; apremilast 20 mg: n = 501). Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment. Greater rates of adverse events (AEs) were reported with apremilast (61.1%; exposure-adjusted incidence rate [EAIR]/100 patient-years, 265.1) versus placebo (47.5%; EAIR/100 patient-years, 200.7) in the placebo-controlled period. During weeks 0 to ≤52, the most common AEs occurring in apremilast-exposed patients were diarrhea (13.9%; EAIR/100 patient-years, 18.6), nausea (12.3%; EAIR/100 patient-years, 16.0), headache (9.4%; EAIR/100 patient-years, 12.1), upper respiratory tract infection (9.1%; EAIR/100 patient-years, 11.5), and nasopharyngitis (6.2%; EAIR/100 patient-years, 7.7). Most AEs were mild/moderate with apremilast exposure ≤156 weeks. Rates of depression remained low (EAIR/100 patient-years, 1.8). Major adverse cardiac events (EAIR/100 patient-years, 0.5), malignancies (EAIR/100 patient-years, 0.9), and serious opportunistic infections (EAIR/100 patient-years, 0.0) were infrequent over the 3-year exposure period. Discontinuation rates due to AEs were low (<7.5%) across all apremilast-exposure periods. Incidences of clinically meaningful abnormalities in postbaseline laboratory values was low; most values returned to baseline levels with continued treatment and without intervention.
CONCLUSION
Apremilast demonstrated a favorable safety profile and was well tolerated up to 156 weeks.",2020,"Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment.","['Patients with active PsA', '1493 patients received at least one dose of study medication and were included in the safety population ', 'Psoriatic Arthritis', 'patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment']","['Apremilast Versus Placebo', 'Placebo', 'placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily', 'placebo']","['headache', 'diarrhea', 'Rates of depression', 'serious opportunistic infections', 'upper respiratory tract infection', 'nasopharyngitis', 'Greater rates of adverse events (AEs', 'nausea', 'Major adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3819585', 'cui_str': 'apremilast 30 MG [Otezla]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3819586', 'cui_str': 'apremilast 20 MG [Otezla]'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1493.0,0.225162,"Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington and University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Gomez-Reino', 'Affiliation': 'Fundación Dominguez, Hospital Clínico Universitario, Santiago, Spain.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Monash University, Cabrini Health, Melbourne, Australia.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego School of Medicine, La Jolla.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'Regional Hospital, University of Orléans, Orléans, France.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schett', 'Affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany und Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Delev', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Teng', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wollenhaupt', 'Affiliation': 'Jürgen Wollenhaupt: Schön Klinik Hamburg Eilbek, Hamburg, Germany.'}]",ACR open rheumatology,['10.1002/acr2.11156']
1689,32715995,Clinical outcomes of TAVI or SAVR in men and women with aortic stenosis at intermediate operative risk: a post hoc analysis of the randomised SURTAVI trial.,"AIMS
In patients with aortic stenosis randomised to transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), sex-specific differences in complication rates are unclear in intermediate-risk patients. The purpose of this analysis was to identify sex-specific differences in outcome for patients at intermediate surgical risk randomised to TAVI or SAVR in the international Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial.
METHODS AND RESULTS
A total of 1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR. The population was stratified by sex and treatment modality (female TAVI=366, male TAVI=498, female SAVR=358, male SAVR=438). The primary endpoint was a composite of all-cause mortality or disabling stroke at two years. Compared to males, females had a smaller body surface area, a higher Society of Thoracic Surgeons score (4.7±1.6% vs 4.3±1.6%, p<0.01) and were more frail. Men required more concomitant revascularisation (23% vs 16%). All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs 10.5%, p=0.90) and males (14.5% vs 14.4%, p=0.99); the difference between females and males was 10.2% vs 14.5%, for TAVI (p=0.08) and 10.5% vs 14.4%, SAVR (p=0.13). Functional status improvement was more pronounced after TAVI in females than in males.
CONCLUSIONS
Aortic valve replacement, either by surgical or transcatheter approach, appears similarly effective and safe for males and females at intermediate surgical risk. Functional status appears to improve most in females after TAVI.
CLINICAL TRIAL REGISTRATION
http://clinicaltrials.gov NCT01586910.",2020,"All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs. 10.5%, p=0.90) and males (14.5% vs. 14.4%, p=0.99); the difference between females and males was 10.2% vs. 14.5%, for TAVI (p=0.08) and 10.5% vs. 14.4%, SAVR (p=0.13).","['Men and Women with Aortic Stenosis at Intermediate Operative Risk', 'males and females at intermediate surgical risk', 'patients with aortic stenosis', '1,660 intermediate-risk patients underwent TAVI with a supra-annular, self-expanding bioprosthesis or SAVR']","['transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR', 'TAVI or SAVR']","['Thoracic Surgeons score', 'composite of all-cause mortality or disabling stroke', 'mortality or disabling stroke', 'Functional status improvement', 'concomitant revascularization']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0005557', 'cui_str': 'Bioprosthesis'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}]","[{'cui': 'C0278626', 'cui_str': 'Thoracic surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",1660.0,0.0296006,"All-cause mortality or disabling stroke at two years was similar between TAVI and SAVR for females (10.2% vs. 10.5%, p=0.90) and males (14.5% vs. 14.4%, p=0.99); the difference between females and males was 10.2% vs. 14.5%, for TAVI (p=0.08) and 10.5% vs. 14.4%, SAVR (p=0.13).","[{'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Department of Interventional Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': ''}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Heiser', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Merhi', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': ''}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': ''}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Robbins', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fail', 'Affiliation': ''}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': ''}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Stoler', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hebeler', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00303']
1690,32719973,Computerized clinical decision system and mobile application with expert support to optimize management of vertigo in primary care: study protocol for a pragmatic cluster-randomized controlled trial.,"Vertigo and dizziness are amongst the most common symptoms in medicine and often have a major impact on activities of daily life. Although many causes of vertigo and dizziness can easily be recognized, patients often receive inappropriate and ineffective treatment. The reasons for this are various. Because vertigo/dizziness is an interdisciplinary symptom and there is a lack of standardised diagnostic tools, it is easy to lose the overview of the possible differential diagnoses. There is evidence though, that the management of patients with vertigo/dizziness can be optimized using standardized care pathways with digital support. The present study (within the framework of ""PoiSe-prevention, online feedback, and interdisciplinary therapy of acute vestibular syndromes by e-health"") aims to evaluate the implementation of a program with several interlocking components. The three main components are a computerized clinical decision system, a mobile application, a counselling and interdisciplinary educational program developed by the German Center for Vertigo and Balance Disorders (DSGZ). The study is a cluster-randomized controlled trial with a parallel-group design, as well as a detailed process evaluation. Clusters comprise of primary care physician practices in Bavaria, Germany. In the scope of the study the effectiveness, acceptability and efficiency of the intervention will be evaluated. It is anticipated that the intervention will improve the quality and efficiency of the management of dizzy patients. A higher diagnostic accuracy, optimized treatment, and disease progression monitoring is expected to improve patient-relevant outcomes and reduce health-care costs.",2020,"There is evidence though, that the management of patients with vertigo/dizziness can be optimized using standardized care pathways with digital support.",['patients with vertigo/dizziness'],[],"['vertigo and dizziness', 'effectiveness, acceptability and efficiency', 'Vertigo and dizziness', 'quality and efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",[],"[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0723732,"There is evidence though, that the management of patients with vertigo/dizziness can be optimized using standardized care pathways with digital support.","[{'ForeName': 'Filipp M', 'Initials': 'FM', 'LastName': 'Filippopulos', 'Affiliation': 'German Center for Vertigo and Balance Disorders, LMU Klinikum, Ludwig Maximilians Universität, Marchioninistraße 15, 81377, Munich, Germany. Filipp.Filippopulos@med.uni-muenchen.de.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Huppert', 'Affiliation': 'German Center for Vertigo and Balance Disorders, LMU Klinikum, Ludwig Maximilians Universität, Marchioninistraße 15, 81377, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brandt', 'Affiliation': 'German Center for Vertigo and Balance Disorders, LMU Klinikum, Ludwig Maximilians Universität, Marchioninistraße 15, 81377, Munich, Germany.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Hermann', 'Affiliation': 'AOK Bayern, Die Gesundheitskasse, Carl-Wery-Straße 28, 81739, Munich, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Franz', 'Affiliation': 'Kassenärztliche Vereinigung Bayerns, Referat Versorgungsinnovationen, Elsenheimerstraße 39, 80687, Munich, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Fleischer', 'Affiliation': 'Institute for Health and Nursing Sciences, Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Straße 8, 06112, Halle (Saale), Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Grill', 'Affiliation': 'Institute of Medical Informatics, Biometry and Epidemiology, Ludwig Maximilians Universität, Marchioninistraße 15, 81377, Munich, Germany.'}]",Journal of neurology,['10.1007/s00415-020-10078-0']
1691,32720085,Losing my loss aversion: The effects of current and past environment on the relative sensitivity to losses and gains.,"It is often assumed that most people are loss averse, placing more weight on losses than commensurate gains; however, some research identifies variability in loss sensitivity that reflects features of the environment. We examined this plasticity in loss sensitivity by manipulating the size and distribution of possible outcomes in a set of mixed gambles, and assessing individual stability in loss sensitivity. In each of two sessions, participants made accept-reject decisions for 64 mixed-outcome gambles. Participants were randomly assigned to conditions defined by the relative range of losses and gains (wider range of losses vs. wider range of gains), and the currency-units at stake ('pennies' vs. 'pounds'). Participants showed modest but non-trivial consistency in their sensitivity to losses; though loss sensitivity also varied substantially with our manipulations. When possible gains had greater range than possible losses, most participants were loss averse; however, when possible losses had the greater range, reverse loss aversion was the norm (i.e., more weight on gains than losses). This is consistent with decision-by-sampling theory, whereby an outcome's rank within a consideration-set determines its value, but can also be explained by the gamble's expected-value rank within the decision-set, or by adapting aspirations to the decision-environment. Loss aversion was also reduced in the second session of decisions when the stakes had been higher in the previous session. This illustrates the influence of prior context on current sensitivity to losses, and suggests a role for idiosyncratic experiences in the development of individual differences in loss sensitivity.",2020,Participants showed modest but non-trivial consistency in their sensitivity to losses; though loss sensitivity also varied substantially with our manipulations.,['Losing my loss aversion'],[],['Loss aversion'],"[{'cui': 'C0233496', 'cui_str': 'Aversion'}]",[],"[{'cui': 'C0233496', 'cui_str': 'Aversion'}]",,0.0406523,Participants showed modest but non-trivial consistency in their sensitivity to losses; though loss sensitivity also varied substantially with our manipulations.,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Rakow', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience - Department of Psychology, King's College London, London, UK. tim.rakow@kcl.ac.uk.""}, {'ForeName': 'Nga Yiu', 'Initials': 'NY', 'LastName': 'Cheung', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience - Department of Psychology, King's College London, London, UK.""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Restelli', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience - Department of Psychology, King's College London, London, UK.""}]",Psychonomic bulletin & review,['10.3758/s13423-020-01775-y']
1692,32725861,Randomized controlled trial comparing Parent Led Therapist Supervised Articulation Therapy (PLAT) with routine intervention for children with speech disorders associated with cleft palate.,"BACKGROUND
A total of 68% of pre-school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non-cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy.
AIMS
To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent-child dyads.
METHODS & PROCEDURES
A total of 44 children, aged 2.9-7.5 years, were included in a two-centre, two-phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent-trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face-to-face session. In the control arm (n = 21), parent-child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre- and post-intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire.
OUTCOMES & RESULTS
There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38-16.27; d = 0.57; sentences: p < 0.002; CI = 16.04-25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45-3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63-25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent-led group) and significant (control group) change in participation.
CONCLUSIONS & IMPLICATIONS
PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper adds What is already known on this subject Over 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent-led therapy with the supervision of a specialist cleft therapist using FaceTime is effective. What this paper adds to existing knowledge This randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care. What are the potential or actual clinical implications of this work? This study indicates that both parent-led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent-led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders.",2020,There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38-16.27; d = 0.57; sentences: p < 0.002; CI = 16.04-25.97; d = 0.23).,"['children with speech disorders associated with cleft palate', 'children with cleft palate speech disorders, under the supervision of an SLT', 'cleft palate and non-cleft speech disorders', 'Participants and speech and language therapists (SLTs', 'children with cleft palate require speech therapy', 'children with cleft palate speech disorders', 'Children', 'A total of 68% of pre-school children with cleft palate have speech problems requiring speech therapy', 'children with cleft palate', '44 children, aged 2.9-7.5 years', 'parent-child dyads']","['Parent Led, Therapist Supervised, Articulation Therapy (PLAT', 'detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face-to-face session', 'routine speech therapy intervention', 'Parent Led Therapist Supervised Articulation Therapy (PLAT) with routine intervention']","['intelligibility', 'Percent consonant correct (PCC', 'Intelligibility in Context Scale (ICS', 'Activity and participation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037822', 'cui_str': 'Speech disorder'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0008925', 'cui_str': 'Cleft palate'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0402015', 'cui_str': 'Speech and language therapist'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0395016', 'cui_str': 'Speech problem'}, {'cui': 'C4517641', 'cui_str': '2.9'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205242', 'cui_str': 'Cleaved'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0589416', 'cui_str': 'Intelligibility'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C4273753', 'cui_str': 'Intelligibility in Context Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",44.0,0.0894954,There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38-16.27; d = 0.57; sentences: p < 0.002; CI = 16.04-25.97; d = 0.23).,"[{'ForeName': 'Triona', 'Initials': 'T', 'LastName': 'Sweeney', 'Affiliation': 'Speech at Home, Dublin, Ireland.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Hegarty', 'Affiliation': ""Children's Health Ireland.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Powell', 'Affiliation': 'South Thames Cleft Service, London, UK.'}, {'ForeName': 'Liane', 'Initials': 'L', 'LastName': 'Deasy', 'Affiliation': 'formerly Loughlinstown Health Centre, Dublin, Ireland (RIP).'}, {'ForeName': ""Myra O'"", 'Initials': 'MO', 'LastName': 'Regan', 'Affiliation': 'Trinity College, Dublin, Ireland.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Sell', 'Affiliation': 'Centre for Outcomes and Experience Research in Health, Impairment and Disability (ORCHID), Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}]",International journal of language & communication disorders,['10.1111/1460-6984.12542']
1693,32722955,"Ranibizumab versus aflibercept for diabetic macular edema: 18-month results of a comparative, prospective, randomized study and multivariate analysis of visual outcome predictors.","PURPOSE
The purpose of this study was to compare the anatomical and functional outcomes of ranibizumab versus aflibercept for the treatment of diabetic macular edema (DME) in a long-term follow-up.
METHODS
Participants in this prospective study were 112 treatment naïve patients with DME, who received treatment with either intravitreal ranibizumab (n = 54) or aflibercept (n = 58). The demographic data, the best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) characteristics were evaluated at baseline and at month 1, 2, 3, 6, 12, and 18 post treatment, while factors affecting visual outcome were determined using multivariate analysis.
RESULTS
At month 18, the mean BCVA of ranibizumab-treated eyes increased 7.9 letters compared to 6.9 letters for eyes receiving aflibercept, with greater number of injections in ranibizumab group (9.2 ± 2.3 vs. 7.6 ± 2.1 injections in the ranibizumab and aflibercept group respectively, p = 0.0002). The difference in letters between the two groups was not statistically significant, nor the difference in central subfield thickness at month 18. Factors associated with poorer BCVA were found to be increasing age, HbA1c ≥7.5%, increasing central retinal thickness and disrupted ellipsoid zone.
CONCLUSIONS
Ranibizumab and aflibercept presented similar anatomical and functional outcomes in 18-month follow-up in patients with DME. It is important to determine factors, affecting VA, so as to provide individualized treatment.",2020,"The difference in letters between the two groups was not statistically significant, nor the difference in central subfield thickness at month 18.","['were 112 treatment naïve patients with DME', 'diabetic macular edema (DME', 'patients with DME', 'diabetic macular edema']","['aflibercept', 'ranibizumab and aflibercept', 'Ranibizumab', 'ranibizumab versus aflibercept', 'intravitreal ranibizumab', 'Ranibizumab and aflibercept', 'ranibizumab']","['mean BCVA', 'spectral-domain optical coherence tomography (SD-OCT) characteristics', 'central subfield thickness', 'central retinal thickness']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}]",112.0,0.0525292,"The difference in letters between the two groups was not statistically significant, nor the difference in central subfield thickness at month 18.","[{'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Chatzirallis', 'Affiliation': '2nd Department of Ophthalmology, Ophthalmiatrion Athinon, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Theodossiadis', 'Affiliation': '2nd Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Droutsas', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Chryssanthi', 'Initials': 'C', 'LastName': 'Koutsandrea', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Ladas', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Marilita M', 'Initials': 'MM', 'LastName': 'Moschos', 'Affiliation': '1st Department of Ophthalmology, National and Kapodistrian University of Athens, Athens, Greece.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2020.1802741']
1694,32723033,Increases in speed do not change gait symmetry or variability in world-class race walkers.,"The aim of this study was to analyse changes in gait variability and symmetry with increasing speed in race walkers. Eighteen international athletes race walked on an instrumented treadmill at speeds of 11, 12, 13 and 14 km·h -1 in a randomised order for 3 min each. Spatiotemporal and ground reaction force data were recorded for 30 s at each speed. Gait variability was measured using median absolute deviation and inter-leg symmetry was measured using the symmetry angle. There was an overall effect of speed on all absolute values except push-off force, but symmetry and variability (except flight time) did not change with increased speed, step length and step frequency. Most athletes were asymmetrical for at least one variable, but none was asymmetrical for more than half of the variables measured. Therefore, being asymmetrical or having higher variability (<5%) in a few variables is normal. Taking all findings together, practitioners should exercise caution when deciding on the need for corrective interventions and should not be concerned that increasing gait speed could increase injury risk through changes to athletes' asymmetry. Race walking coaches should test at competition speeds to ensure that flight times, and any variability or asymmetry, are measured appropriately.",2020,"There was an overall effect of speed on all absolute values except push-off force, but symmetry and variability (except flight time) did not change with increased speed, step length and step frequency.","['Eighteen international athletes race walked on an instrumented treadmill at speeds of 11, 12, 13 and 14 km·h -1']",[],"['speed, step length and step frequency', 'gait variability and symmetry', 'Gait variability']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",[],"[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}]",18.0,0.0396385,"There was an overall effect of speed on all absolute values except push-off force, but symmetry and variability (except flight time) did not change with increased speed, step length and step frequency.","[{'ForeName': 'Catherine B', 'Initials': 'CB', 'LastName': 'Tucker', 'Affiliation': 'Carnegie School of Sport, Headingley Campus, Leeds Beckett University , Leeds, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hanley', 'Affiliation': 'Carnegie School of Sport, Headingley Campus, Leeds Beckett University , Leeds, UK.'}]",Journal of sports sciences,['10.1080/02640414.2020.1798730']
1695,32730052,Implementation intentions and prospective memory function in late adulthood.,"Prospective memory (PM) is a critically important component of memory that often declines in late adulthood. Implementation intentions, an encoding strategy, consisting of an explicit if-then ""I will . . ."" statement, has been effectively used to enhance older adults' prospective memory function. However, it remains to be established whether forming a mental representation of carrying out the task when forming the intention enhances these age effects, as well as whether the type of cue (event or time based) moderates age-related benefits. To test these questions, we randomly allocated 125 younger and 125 older adults to 1 of 5 conditions, in which they were directed to use different strategies when forming their PM intentions (Statement Only, Imagine in Game, Statement and Imagine Combined, Imagine in Daily Life, Control). The results indicated that use of the implementation intentions statement alone and in combination with forming a mental representation of carrying out the task substantially enhanced older adults' event- but not time-based PM. In addition, while the Statement Only condition reduced age-related difficulties for event-based tasks, the condition that combined this statement with visualization led to the greatest reduction in age effects. These data suggest that both rehearsing the implementations intention in the specific statement format combined with visualizing may be optimally effective for enhancing PM function in late adulthood but that the type of PM cue is an important moderator of these age effects. In addition to theoretical implications, these results may inform the refinement of interventions focused on enhancing PM function in late adulthood. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,The results indicated that use of the implementation intentions statement alone and in combination with forming a mental representation of carrying out the task substantially enhanced older adults' event- but not time-based PM.,"['125 younger and 125 older adults to 1 of 5 conditions', 'late adulthood']","['PM intentions (Statement Only, Imagine in Game, Statement and Imagine Combined, Imagine in Daily Life, Control']","[""older adults' event- but not time-based PM""]","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0700597', 'cui_str': 'Adulthood'}]","[{'cui': 'C0589154', 'cui_str': 'Prospective memory'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0589154', 'cui_str': 'Prospective memory'}]",,0.0229072,The results indicated that use of the implementation intentions statement alone and in combination with forming a mental representation of carrying out the task substantially enhanced older adults' event- but not time-based PM.,"[{'ForeName': 'Julie D', 'Initials': 'JD', 'LastName': 'Henry', 'Affiliation': 'School of Psychology, The University of Queensland.'}, {'ForeName': 'Gill', 'Initials': 'G', 'LastName': 'Terrett', 'Affiliation': 'Department of Psychology, Australian Catholic University.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Grainger', 'Affiliation': 'School of Psychology, The University of Queensland.'}, {'ForeName': 'Nathan S', 'Initials': 'NS', 'LastName': 'Rose', 'Affiliation': 'Department of Psychology, University of Notre Dame.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kliegel', 'Affiliation': 'School of Psychology, University of Geneva.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bugge', 'Affiliation': ''}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Ryrie', 'Affiliation': 'Department of Psychology, Australian Catholic University.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Rendell', 'Affiliation': 'Department of Psychology, Australian Catholic University.'}]",Psychology and aging,['10.1037/pag0000563']
1696,32743594,COVIDOSE: Low-dose tocilizumab in the treatment of Covid-19.,"Background Interleukin-6 (IL-6)-mediated hyperinflammation may contribute to the high mortality of coronavirus disease 2019 (Covid-19). Tocilizumab, an IL-6 receptor blocking monoclonal antibody, has been repurposed for Covid-19, but prospective trials and dose-finding studies in Covid-19 are lacking. Methods We conducted a phase 2 trial of low-dose tocilizumab in hospitalized adult patients with Covid-19, radiographic pulmonary infiltrate, fever, and C-reactive protein (CRP) >= 40 mg/L who did not require mechanical ventilation. Dose cohorts were determined by a trial Operations Committee, stratified by CRP and epidemiologic risk factors. A range of doses from 40 to 200 mg (low-dose tocilizumab) was evaluated, with allowance for one repeat dose at 24-48 hours. The primary objective was to assess the relationship of dose to fever resolution and CRP response. Outcomes were compared with retrospective controls with Covid-19. Correlative studies evaluating host antibody response were performed in parallel. Findings A total of 32 patients received low-dose tocilizumab. This cohort had improved fever resolution (75.0% vs. 34.2%, p = 0.001) and CRP decline (86.2% vs. 14.3%, p < 0.001) in the 24-48 hours following drug administration, as compared to the retrospective controls (N=41). The probabilities of fever resolution or CRP decline did not appear to be dose-related in this small study (p=0.80 and p=0.10, respectively). Within the 28-day follow-up, 5 (15.6%) patients died. For patients who recovered, median time to clinical recovery was 3 days (IQR, 2-5). Clinically presumed and/or cultured bacterial superinfections were reported in 5 (15.6%) patients. Correlative biological studies demonstrated that tocilizumab-treated patients produced anti-SARS-CoV-2 antibodies comparable to controls. Interpretation Low-dose tocilizumab was associated with rapid improvement in clinical and laboratory measures of hyperinflammation in hospitalized patients with Covid-19. Results of this trial and its correlative biological studies provide rationale for a randomized, controlled trial of low-dose tocilizumab in Covid-19.",2020,"This cohort had improved fever resolution (75.0% vs. 34.2%, p = 0.001) and CRP decline (86.2% vs. 14.3%, p < 0.001) in the 24-48 hours following drug administration, as compared to the retrospective controls (N=41).","['32 patients received', 'hospitalized adult patients with Covid-19, radiographic pulmonary infiltrate, fever, and C-reactive protein (CRP) >= 40 mg/L who did not require mechanical ventilation', 'hospitalized patients with Covid-19']","['low-dose tocilizumab', 'Tocilizumab', 'tocilizumab']","['fever resolution', 'median time to clinical recovery', 'relationship of dose to fever resolution and CRP response', 'CRP decline', 'probabilities of fever resolution or CRP decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",32.0,0.285825,"This cohort had improved fever resolution (75.0% vs. 34.2%, p = 0.001) and CRP decline (86.2% vs. 14.3%, p < 0.001) in the 24-48 hours following drug administration, as compared to the retrospective controls (N=41).","[{'ForeName': 'Garth W', 'Initials': 'GW', 'LastName': 'Strohbehn', 'Affiliation': ''}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Heiss', 'Affiliation': ''}, {'ForeName': 'Sherin J', 'Initials': 'SJ', 'LastName': 'Rouhani', 'Affiliation': ''}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Trujillo', 'Affiliation': ''}, {'ForeName': 'Jovian', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Alec J', 'Initials': 'AJ', 'LastName': 'Kacew', 'Affiliation': ''}, {'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Higgs', 'Affiliation': ''}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Bloodworth', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Cabanov', 'Affiliation': ''}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Wright', 'Affiliation': ''}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Koziol', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Weiss', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Danahey', 'Affiliation': ''}, {'ForeName': 'Theodore G', 'Initials': 'TG', 'LastName': 'Karrison', 'Affiliation': ''}, {'ForeName': 'Cuoghi C', 'Initials': 'CC', 'LastName': 'Edens', 'Affiliation': ''}, {'ForeName': 'Iazsmin Bauer', 'Initials': 'IB', 'LastName': 'Ventura', 'Affiliation': ''}, {'ForeName': 'Natasha N', 'Initials': 'NN', 'LastName': 'Pettit', 'Affiliation': ''}, {'ForeName': 'Bhakti', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pisano', 'Affiliation': ''}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Strek', 'Affiliation': ''}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': ''}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Ratain', 'Affiliation': ''}, {'ForeName': 'Pankti D', 'Initials': 'PD', 'LastName': 'Reid', 'Affiliation': ''}]",medRxiv : the preprint server for health sciences,['10.1101/2020.07.20.20157503']
1697,32745306,A phase 2B randomised trial of hyperbaric oxygen therapy for ulcerative colitis patients hospitalised for moderate to severe flares.,"BACKGROUND
Hyperbaric oxygen has been reported to improve disease activity in hospitalised ulcerative colitis (UC) patients.
AIM
To evaluate dosing strategies with hyperbaric oxygen for hospitalised UC patients.
METHODS
We enrolled UC patients hospitalised for acute flares (Mayo score 6-12). Initially, all patients received 3 days of hyperbaric oxygen at 2.4 atmospheres (90 minutes with two air breaks) in addition to intravenous steroids. Day 3 responders (reduction of partial Mayo score ≥ 2 points and rectal bleeding score ≥ 1 point) were randomised to receive a total of 5 days vs 3 days of hyperbaric oxygen.
RESULTS
We treated 20 patients with hyperbaric oxygen (75% prior biologic failure). Day 3 response was achieved in 55% (n = 11/20), with significant reductions in stool frequency, rectal bleeding and CRP (P < 0.01). A more significant reduction in disease activity was observed with 5 days vs 3 days of hyperbaric oxygen (P = 0.03). Infliximab or colectomy was required in only three patients (15%) despite a predicted probability of 80% for second-line therapy. Day 3 hyperbaric oxygen responders were less likely to require re-hospitalisation or colectomy by 3 months vs non-responders (0% vs 66%, P = 0.002). No treatment-related adverse events were observed.
CONCLUSION
Hyperbaric oxygen appears to be effective for optimising response to intravenous steroids in UC patients hospitalised for acute flares, with low rates of re-hospitalisation or colectomy at 3 months. An optimal clinical response is achieved with 5 days of hyperbaric oxygen. Larger phase 3 trials are needed to confirm efficacy and obtain labelled approval.",2020,"Day 3 hyperbaric oxygen responders were less likely to require re-hospitalisation or colectomy by 3 months vs non-responders (0% vs 66%, P = 0.002).","['hospitalised ulcerative colitis (UC) patients', 'hospitalised UC patients', 'enrolled UC patients hospitalised for acute flares (Mayo score 6-12', '20 patients with hyperbaric oxygen (75% prior biologic failure', 'ulcerative colitis patients hospitalised for moderate to severe flares', 'UC patients hospitalised for acute flares']","['hyperbaric oxygen at 2.4 atmospheres (90\xa0minutes with two air breaks) in addition to intravenous steroids', 'Hyperbaric oxygen', 'Infliximab or colectomy', 'hyperbaric oxygen therapy', 'hyperbaric oxygen']","['require re-hospitalisation or colectomy', 'disease activity', 'stool frequency, rectal bleeding and CRP', 'adverse events']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0563322', 'cui_str': 'Intravenous steroid injection'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0009274', 'cui_str': 'Excision of colon'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0009274', 'cui_str': 'Excision of colon'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.0836522,"Day 3 hyperbaric oxygen responders were less likely to require re-hospitalisation or colectomy by 3 months vs non-responders (0% vs 66%, P = 0.002).","[{'ForeName': 'Parambir S', 'Initials': 'PS', 'LastName': 'Dulai', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Raffals', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hudesman', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chiorean', 'Affiliation': 'Virginia Mason, Seattle, WA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Cross', 'Affiliation': 'University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Tasneem', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Winter', 'Affiliation': 'Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fudman', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sadler', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Ernest L', 'Initials': 'EL', 'LastName': 'Chiu', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Ross', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Toups', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Murad', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kinjal', 'Initials': 'K', 'LastName': 'Sethuraman', 'Affiliation': 'University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Holm', 'Affiliation': 'Virginia Mason, Seattle, WA, USA.'}, {'ForeName': 'Renie', 'Initials': 'R', 'LastName': 'Guilliod', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Levine', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Buckey', 'Affiliation': 'Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Siegel', 'Affiliation': 'Dartmouth Hitchcock Medical Center, Lebanon, NH, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15984']
1698,32755035,Phase II Randomized Trial of Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis.,"OBJECTIVE
To assess the safety, mechanism of action, and preliminary efficacy of rituximab followed by belimumab in the treatment of refractory lupus nephritis (LN).
METHODS
In a multicenter, randomized, open-label clinical trial, 43 patients with recurrent or refractory LN were treated with rituximab, cyclophosphamide (CYC), and glucocorticoids followed by weekly belimumab infusions until week 48 (RCB group) or with rituximab and CYC but no belimumab infusions (RC group). Patients were followed up until week 96. Percentages of total and autoreactive B cell subsets in the patients' peripheral blood were analyzed by flow cytometry.
RESULTS
Treatment with belimumab did not increase the incidence of adverse events in patients with refractory LN. At week 48, a complete or partial renal response occurred in 11 (52%) of 21 patients receiving belimumab, compared to 9 (41%) of 22 patients in the RC group who did not receive belimumab (P = 0.452). Lack of improvement in or worsening of LN was the major reason for treatment failure. B cell depletion occurred in both groups, but the percentage of B cells remained lower in those receiving belimumab (geometric mean number of B cells at week 60, 53 cells/μl in the RCB group versus 11 cells/μl in the RC group; P = 0.0012). Percentages of total and autoreactive transitional B cells increased from baseline to week 48 in both groups. However, percentages of total and autoreactive naive B cells decreased from baseline to week 48 in the belimumab group compared to the no belimumab RC group (P = 0.0349), a finding that is consistent with impaired maturation of naive B cells and enhanced censoring of autoreactive B cells.
CONCLUSION
The addition of belimumab to a treatment regimen with rituximab and CYC was safe in patients with refractory LN. This regimen diminished maturation of transitional to naive B cells during B cell reconstitution, and enhanced the negative selection of autoreactive B cells. Clinical efficacy was not improved with rituximab and CYC in combination with belimumab when compared to a therapeutic strategy of B cell depletion alone in patients with LN.",2020,"The percentage of total and autoreactive transitional B cells increased from baseline to Week 48 in both groups, however the percentage of total and autoreactive naïve B cells (p=0.0349) decreased in the belimumab group, consistent with impaired maturation of naïve B cells and enhanced censoring of autoreactive B cells.
","['Forty three participants with recurrent or refractory lupus nephritis were treated with', 'Lupus Nephritis']","['Rituximab Plus Cyclophosphamide', 'rituximabfollowed', 'rituximab and cyclophosphamide', 'CALIBRATE', 'rituximab, cyclophosphamide, and glucocorticoids, followed by randomization to belimumab infusions (RCB) until Week 48, or no infusion (RC']","['maturation of naïve B cells and enhanced censoring of autoreactive B cells', 'clinical efficacy', 'percentage of total and autoreactive transitional B cells', 'B cell depletion', 'complete or partial renal response', 'Total and autoreactive B cell subsets', 'incidence of adverse events', 'percentage of total and autoreactive naïve B cells']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0024143', 'cui_str': 'SLE glomerulonephritis syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1723401', 'cui_str': 'belimumab'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1512631', 'cui_str': 'Immature B-Lymphocytes'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0079004', 'cui_str': 'B-Cell Subsets'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",43.0,0.0654134,"The percentage of total and autoreactive transitional B cells increased from baseline to Week 48 in both groups, however the percentage of total and autoreactive naïve B cells (p=0.0349) decreased in the belimumab group, consistent with impaired maturation of naïve B cells and enhanced censoring of autoreactive B cells.
","[{'ForeName': 'Yemil', 'Initials': 'Y', 'LastName': 'Atisha-Fregoso', 'Affiliation': 'Feinstein Institutes for Medical Research, and Elmezzi Graduate School of Molecular Medicine at Northwell Health, Manhasset, New York.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Malkiel', 'Affiliation': 'Feinstein Institute for Medical Research, Manhasset, New York.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Harris', 'Affiliation': 'Immune Tolerance Network, San Francisco, California.'}, {'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Byron', 'Affiliation': 'Rho, Durham, North Carolina.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Kanaparthi', 'Affiliation': 'Immune Tolerance Network, San Francisco, California.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': 'Rho, Durham, North Carolina.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Ryker', 'Affiliation': 'Immune Tolerance Network, San Francisco, California.'}, {'ForeName': 'Patti', 'Initials': 'P', 'LastName': 'Tosta', 'Affiliation': 'Immune Tolerance Network, San Francisco, California.'}, {'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Boackle', 'Affiliation': 'University of Colorado, Denver.'}, {'ForeName': 'W Winn', 'Initials': 'WW', 'LastName': 'Chatham', 'Affiliation': 'University of Alabama at Birmingham, San Francisco.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Kamen', 'Affiliation': 'Medical University of South Carolina, Charleston.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Karp', 'Affiliation': 'UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Kyriakos A', 'Initials': 'KA', 'LastName': 'Kirou', 'Affiliation': 'Hospital for Special Surgery, New York, New York.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sam Lim', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Marder', 'Affiliation': 'Medical Center of Aurora, Aurora, Colorado.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'McMahon', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Samir V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'Ohio State University Wexner Medical Center, Columbus.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Pendergraft', 'Affiliation': 'University of North Carolina Kidney Center, Chapel Hill.'}, {'ForeName': 'Amber S', 'Initials': 'AS', 'LastName': 'Podoll', 'Affiliation': 'University of Colorado, Denver.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Saxena', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wofsy', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'Feinstein Institute for Medical Research, Manhasset, New York.'}, {'ForeName': 'Dawn E', 'Initials': 'DE', 'LastName': 'Smilek', 'Affiliation': 'Immune Tolerance Network, San Francisco, California.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'Feinstein Institute for Medical Research, Manhasset, New York.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""Dall'Era"", 'Affiliation': 'University of California, San Francisco.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41466']
1699,32751430,Relief Alternatives during Resuscitation: Instructions to Teach Bystanders. A Randomized Control Trial.,"To analyze the quality of resuscitation (CPR) performed by individuals without training after receiving a set of instructions (structured and unstructured/intuitive) from an expert in a simulated context, the specific objective was to design a simple and structured CPR learning method on-site. An experimental study was designed, consisting of two random groups with a post-intervention measurement in which the experimental group (EG) received standardized instructions, and the control group (CG) received intuitive or non-standardized instructions, in a public area simulated scenario. Statistically significant differences were found ( p < 0.0001) between the EG and the CG for variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil. The average depth of the EG was 51.1 mm (SD 7.94) and 42.2 mm (SD 12.04) for the CG. The chest recoil median was 86.32% (IQR 62.36, 98.87) for the EG, and 58.3% (IQR 27.46, 84.33) in the CG. The use of a sequence of simple, short and specific orders, together with observation-based learning makes possible the execution of chest compression maneuvers that are very similar to those performed by rescuers, and allows the teaching of the basic notions of ventilation. The structured order method was shown to be an on-site learning opportunity when faced with the need to maintain high-quality CPR in the presence of an expert resuscitator until the arrival of emergency services.",2020,"Statistically significant differences were found ( p < 0.0001) between the EG and the CG for variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil.",[],"['standardized instructions, and the control group (CG) received intuitive or non-standardized instructions, in a public area simulated scenario']","['chest recoil median', 'average depth of the EG', 'quality of resuscitation (CPR', 'variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil']",[],"[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0205142,"Statistically significant differences were found ( p < 0.0001) between the EG and the CG for variables: time needed to give orders, pauses between chest compressions and ventilations, depth, overall score, chest compression score, and chest recoil.","[{'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Pujalte-Jesús', 'Affiliation': 'Faculty of Nursing, Universidad Católica de Murcia UCAM, 30107 Murcia, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Leal-Costa', 'Affiliation': 'Faculty of Nursing, University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ruzafa-Martínez', 'Affiliation': 'Faculty of Nursing, University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'Antonio Jesús', 'Initials': 'AJ', 'LastName': 'Ramos-Morcillo', 'Affiliation': 'Faculty of Nursing, University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Díaz Agea', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia, 30107 Murcia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17155495']
1700,32710658,Hospital Elder Life Program in Long-Term Care (HELP-LTC): A Cluster Randomized Controlled Trial.,"BACKGROUND/OBJECTIVES
The Hospital Elder Life Program (HELP) has been shown to prevent delirium in hospitalized older adults. The objective of this study was to test the efficacy of HELP adapted to long-term care (HELP-LTC).
DESIGN
Cluster randomized controlled trial.
SETTING
A 514-bed academic urban nursing home.
PARTICIPANTS
A total of 219 long-term nursing home residents who developed an acute illness or change in condition were randomly assigned to HELP-LTC (n = 105) or usual care (n = 114) by unit.
INTERVENTION
HELP-LTC is a multicomponent intervention targeting delirium risk factors of cognitive impairment, immobility, dehydration, and malnutrition. Two certified nursing assistants (CNAs) delivered HELP-LTC components twice daily 7 days per week. In addition, recommendations were given to primary providers to reduce medications associated with delirium.
MEASUREMENTS
Delirium (primary outcome) and delirium severity were ascertained each weekday by a research assistant blinded to group assignment, using the Confusion Assessment Method (CAM) and CAM severity score (CAM-S), respectively. Cognitive function was determined using the Cognitive Performance Scale (CPS). Hospitalization was ascertained by chart review.
RESULTS
Participants were 81.7 years of age on average and 65.3% female. At baseline, usual care group participants had better cognitive function than intervention group participants (CPS = 1.33 vs 2.25; P = .004). Delirium symptoms declined over the course of the episode (mean CAM-S = 3.63 at start vs 3.27 at end). Overall, 33.8% of the total sample experienced incident delirium. After adjusting for baseline cognitive function, no significant differences were found in delirium or delirium severity between intervention and usual care groups. Hospitalization was not significantly different between groups.
CONCLUSION
An intervention targeting delirium risk in long-term nursing home residents did not prevent delirium or reduce delirium symptoms. Baseline differences in cognitive function between groups, greater than expected improvements in both groups, quality-enhancing practices such as consistent assignments delivered to both groups, and adaptations of the intervention may have biased results toward null. J Am Geriatr Soc 68:2329-2335, 2020.",2020,"After adjusting for baseline cognitive function, no significant differences were found in delirium or delirium severity between intervention and usual care groups.","['A total of 219 long-term nursing home residents who developed an acute illness or change in condition', 'Participants were 81.7\u2009years of age on average and 65.3% female', 'hospitalized older adults', 'n = 105) or usual care (n = 114) by unit', 'A 514-bed academic urban nursing home']","['LTC', 'Hospital Elder Life Program in Long-Term Care (HELP-LTC', 'HELP-LTC']","['Confusion Assessment Method (CAM) and CAM severity score (CAM-S', 'Hospitalization', 'Delirium symptoms', 'Delirium (primary outcome) and delirium severity', 'cognitive function', 'Cognitive function', 'Cognitive Performance Scale (CPS', 'delirium or delirium severity', 'incident delirium']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C4521843', 'cui_str': 'US Military Commissioned Officer O5'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",219.0,0.256808,"After adjusting for baseline cognitive function, no significant differences were found in delirium or delirium severity between intervention and usual care groups.","[{'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Boockvar', 'Affiliation': 'The New Jewish Home, New York, New York, USA.'}, {'ForeName': 'Kimberly M', 'Initials': 'KM', 'LastName': 'Judon', 'Affiliation': 'James J. Peters VA Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Eimicke', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, New York, USA.'}, {'ForeName': 'Jeanne A', 'Initials': 'JA', 'LastName': 'Teresi', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, New York, USA.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Aging Brain Center, Marcus Institute for Aging Research, Hebrew SeniorLife, Boston, Massachusetts, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16695']
1701,32710677,"Rationale, design, and baseline characteristics of the Salt Substitute in India Study (SSiIS): The protocol for a double-blinded, randomized-controlled trial.","Reduced-sodium, added-potassium salt substitutes have favorable effects on blood pressure, but have not been tested in India. The Salt Substitute in India Study (SSiIS) is a double-blinded, randomized-controlled trial designed to investigate the effects of reduced-sodium, added-potassium salt substitution to replace usual cooking salt use and blood pressure (BP) among hypertensive patients in rural India. The primary objective is to assess effects on systolic blood pressure at 3 months. The secondary objectives are to determine effects on diastolic blood pressure, urinary sodium, and potassium levels, and to determine acceptability of the intervention. Eligible individuals received usual salt (100% sodium chloride) or salt substitute (70% sodium chloride and 30% potassium chloride) to replace all salt required for cooking and seasoning in the household. A total of 502 participants aged ≥18 years with a history of hypertension were successfully recruited and randomized in a 1:1 ratio to intervention or control, between November 2019 and January 2020. Mean blood pressure at baseline was 133.5/83.6 mm Hg and 96% were using one or more blood pressure-lowering medications. The overall mean average 24-hour urinary sodium excretion was 2825 (SD, 1166) mg/L, which corresponds to a urinary salt excretion of 10.4 g/d. Baseline findings suggest sodium intake in this population significantly exceeds World Health Organization recommendations. The SSiIS trial has successfully recruited participants and is well placed to determine whether salt substitution is an effective means of lowering blood pressure for rural Indian patients with hypertension.",2020,Mean blood pressure at baseline was 133.5/83.6 mm ,"['rural Indian patients with hypertension', '502 participants aged ≥18\xa0years with a history of hypertension were successfully recruited and randomized in a 1:1 ratio to intervention or control, between November 2019 and January 2020', 'hypertensive patients in rural India']","['reduced-sodium, added-potassium salt substitution', 'usual salt (100% sodium chloride) or salt substitute (70% sodium chloride and 30% potassium chloride) to replace all salt required for cooking and seasoning in the household']","['blood pressure', 'blood pressure-lowering medications', 'diastolic blood pressure, urinary sodium, and potassium levels', 'blood pressure (BP', 'systolic blood pressure', 'Mean blood pressure', 'overall mean average 24-hour urinary sodium excretion']","[{'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",502.0,0.448347,Mean blood pressure at baseline was 133.5/83.6 mm ,"[{'ForeName': 'Sudhir Raj', 'Initials': 'SR', 'LastName': 'Thout', 'Affiliation': 'The George Institute for Global Health India, Punjagutta, Hyderabad, India.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Maoyi', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Huffman', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Devarsetty', 'Affiliation': 'The George Institute for Global Health India, Punjagutta, Hyderabad, India.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Pettigrew', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Jason H Y', 'Initials': 'JHY', 'LastName': 'Wu', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13947']
1702,32716706,Delayed Denosumab Injections and Fracture Risk Among Patients With Osteoporosis : A Population-Based Cohort Study.,"BACKGROUND
Denosumab is effective for osteoporosis, but discontinuation leads to rapid reversal of its therapeutic effect.
OBJECTIVE
To estimate the risk for fracture among users of denosumab who delayed subsequent doses compared with users who received doses on time.
DESIGN
Population-based cohort study.
SETTING
The Health Improvement Network U.K. primary care database, 2010 to 2019.
PATIENTS
Persons aged 45 years or older who initiated denosumab therapy for osteoporosis.
MEASUREMENTS
Observational data were used to emulate an analysis of a hypothetical trial with 3 dosing intervals: subsequent denosumab injection given within 4 weeks after the recommended date (""on time""), delay by 4 to 16 weeks (""short delay""), and delay by more than 16 weeks (""long delay""). The primary outcome was a composite of all fracture types at 6 months after the recommended date. Secondary outcomes were major osteoporotic fracture, vertebral fracture, hip fracture, and nonvertebral fracture.
RESULTS
Investigators identified 2594 patients initiating denosumab therapy. The risk for composite fracture over 6 months was 27.3 in 1000 for on-time dosing, 32.2 in 1000 for short delay, and 42.4 in 1000 for long delay. Compared with on-time injections, short delay had a hazard ratio (HR) for composite fracture of 1.03 (95% CI, 0.63 to 1.69) and long delay an HR of 1.44 (CI, 0.96 to 2.17) ( P for trend = 0.093). For vertebral fractures, short delay had an HR of 1.48 (CI, 0.58 to 3.79) and long delay an HR of 3.91 (CI, 1.62 to 9.45).
LIMITATION
Dosing schedules were not randomly assigned.
CONCLUSION
Although delayed administration of subsequent denosumab doses by more than 16 weeks is associated with increased risk for vertebral fracture compared with on-time dosing, evidence is insufficient to conclude that fracture risk is increased at other anatomical sites with long delay.
PRIMARY FUNDING SOURCE
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation.",2020,"Compared with on-time injections, short delay had a hazard ratio (HR) for composite fracture of 1.03 (95% CI, 0.63 to 1.69) and long delay an HR of 1.44 (CI, 0.96 to 2.17) ( P for trend = 0.093).","['Population-based cohort study', '2594 patients initiating denosumab therapy', 'The Health Improvement Network U.K. primary care database, 2010 to 2019', 'Patients With Osteoporosis', 'Persons aged 45 years or older who initiated denosumab therapy for osteoporosis']",[],"['major osteoporotic fracture, vertebral fracture, hip fracture, and nonvertebral fracture', 'composite of all fracture types', 'hazard ratio (HR) for composite fracture', 'risk for vertebral fracture', 'Fracture Risk']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0457357', 'cui_str': 'Type of fracture'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2594.0,0.10165,"Compared with on-time injections, short delay had a hazard ratio (HR) for composite fracture of 1.03 (95% CI, 0.63 to 1.69) and long delay an HR of 1.44 (CI, 0.96 to 2.17) ( P for trend = 0.093).","[{'ForeName': 'Houchen', 'Initials': 'H', 'LastName': 'Lyu', 'Affiliation': ""National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation, General Hospital of Chinese PLA, Beijing, China, Xiangya Hospital of Central South University, Changsha, China, and Brigham and Women's Hospital, Boston, Massachusetts (H.L.).""}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.Y., S.K.T.).""}, {'ForeName': 'Sizheng S', 'Initials': 'SS', 'LastName': 'Zhao', 'Affiliation': 'Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, United Kingdom (S.S.Z.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Health Management Center, Xiangya Hospital of Central South University, Changsha, China (J.W.).'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'Xiangya Hospital of Central South University, Changsha, China (C.Z.).'}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.Y., S.K.T.).""}, {'ForeName': 'Benjamin Z', 'Initials': 'BZ', 'LastName': 'Leder', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (B.Z.L.).'}, {'ForeName': 'Guanghua', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'National Clinical Research Center for Geriatric Disorders, Xiangya Hospital of Central South University, and Hunan Key Laboratory of Joint Degeneration and Injury, Changsha, China (G.L.).'}, {'ForeName': 'Peifu', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': 'National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation, General Hospital of Chinese PLA, Beijing, China (P.T.).'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.H.S.).""}]",Annals of internal medicine,['10.7326/M20-0882']
1703,32718147,Evaluating the effects of probiotics in pediatrics with recurrent abdominal pain.,"BACKGROUND
Recurrent abdominal pain (RAP) is one of the frequent complaints in general practice, particularly in pediatrics and is among the common cause of referral to gastroenterology clinics.
PURPOSE
This study is designed to investigate the effects of probiotics for the treatment of RAP and desired therapeutic outcomes.
METHODS
One hundred twenty-five children with the diagnosis of RAP according to Rome III criteria for irritable bowel syndrome (IBS), functional abdominal pain (FAP), functional dyspepsia (FD), and abdominal migraine (AM), were enrolled in this double-blind randomized controlled trial.
RESULTS
Sixty-five subjects received probiotics, and others received placebo treatment for 4 weeks. Lactobacillus reuteri was therapeutically effective in 32 patients compared to 8 patients, responding to the placebo treatment. Compared to baseline, all pain-related variables showed a significant reduction for the IBS and FD at the end of the 4th week. However, it did not respond well in FAP and AM groups. Pain-related outcomes such as, frequency of the pain, severity, and duration of the pain were decreased following the probiotic treatment. No therapeutic response was seen in AM group after the administration of probiotics. L. reuteri significantly led to pain relief in the overall population, and also in FAP, FD, and IBS subgroups.
CONCLUSION
L. reuteri probiotics are likely to lead to RAP relief and can be recommended for the treatment of functional gastrointestinal disorders.",2020,"Lactobacillus Reuteri significantly led to pain relief in the overall population, and also in FAP, FD and IBS subgroups.
","['Pediatrics with Recurrent Abdominal Pain', '125 children with the diagnosis of RAP according to Rome III criteria for IBS, Functional Abdominal Pain (FAP), Functional Dyspepsia (FD) and Abdominal Migraine (AM', '65 subjects received']","['Probiotics', 'probiotics, and others received placebo']","['pain relief', 'therapeutic response', 'frequency of the pain, severity and duration of the pain', 'IBS and FD']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2585575', 'cui_str': 'Recurrent abdominal pain'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1609533', 'cui_str': 'Functional abdominal pain'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0270858', 'cui_str': 'Abdominal migraine'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}]",125.0,0.0462978,"Lactobacillus Reuteri significantly led to pain relief in the overall population, and also in FAP, FD and IBS subgroups.
","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rahmani', 'Affiliation': 'Pediatric Gastroenterology and Hepatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Ghouran-Orimi', 'Affiliation': 'Iran university of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Motamed', 'Affiliation': 'Pediatric Gastroenterology and Hepatology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Moradzadeh', 'Affiliation': ""Department of Pediatric Gastroenterology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.""}]",Clinical and experimental pediatrics,['10.3345/cep.2019.01613']
1704,32718787,A Prospective Randomized Trial Comparing the Functional Results of Buddy Taping Versus Closed Reduction and Cast Immobilization in Patients With Fifth Metacarpal Neck Fractures.,"PURPOSE
Although fifth metacarpal neck fractures are typically treated nonsurgically, most often with closed reduction and orthosis immobilization, cast immobilization may not improve outcomes compared with buddy taping without reduction. The aim of this study was to compare functional outcomes of buddy taping versus reduction and cast immobilization in patients with fifth metacarpal neck fractures.
METHODS
Adult patients with acute fifth metacarpal neck fractures with less than 70º volar angulation and without rotational deformity were randomly assigned to be treated either with buddy taping or a cast after closed reduction. The primary outcome was the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score at 9 weeks. Secondary outcomes included the DASH score at 3 weeks and 1 year, range of motion of the metacarpophalangeal joint, pain, grip strength, return to work, radiographic angulation, and complication rate.
RESULTS
We recruited 72 patients between August 2016 and January 2018. After 3 weeks, the DASH score was significantly lower for patients treated with buddy taping (19.7 ± 19.7) compared with cast immobilization (44.6 ± 15.0). At 9 weeks, clinical outcomes in the buddy taping group were better in terms of range of motion and DASH score, with a mean difference of 6.3 points, which did not exceed the minimally clinically important difference. There were more complications in the cast immobilization group. Fracture angulation after reduction was followed by a loss of reduction at 3 weeks' follow-up and equivalent residual radiographic volar angulation was observed at 3 and 9 weeks after injury in both groups. Duration of time off from work was 28 days shorter with buddy taping compared with cast treatment.
CONCLUSIONS
There is no benefit to reduction and orthosis immobilization of fifth metacarpal neck fractures with an initial angulation less than 70°. Use of buddy taping and early mobilization had good clinical results as well as significant improvement in time lost from work.
TYPE OF STUDY/LEVEL OF EVIDENCE
Therapeutic I.",2020,"At 9 weeks, clinical outcomes in the buddy taping group were better in terms of range of motion and DASH score, with a mean difference of 6.3 points, which did not exceed the minimally clinically important difference.","['Patients With Fifth Metacarpal Neck Fractures', 'Adult patients with acute fifth metacarpal neck fractures with less than 70º volar angulation and without rotational deformity', 'patients with fifth metacarpal neck fractures', '72 patients between August 2016 and January 2018']","['buddy taping or a cast after closed reduction', 'buddy taping', 'buddy\xa0taping versus reduction and cast immobilization', 'Buddy Taping Versus Closed Reduction and Cast Immobilization']","['Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score', 'range of motion and DASH score', 'DASH score at 3 weeks and 1 year, range of motion of the metacarpophalangeal joint, pain, grip strength, return to work, radiographic angulation, and complication rate', 'Fracture angulation', 'residual radiographic volar angulation', 'DASH score', 'Duration of time off from work']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0730166', 'cui_str': 'Fifth metacarpal bone structure'}, {'cui': 'C0262414', 'cui_str': 'Fracture of cervical spine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal joint structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0333179', 'cui_str': 'Angulated'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}]",72.0,0.0843819,"At 9 weeks, clinical outcomes in the buddy taping group were better in terms of range of motion and DASH score, with a mean difference of 6.3 points, which did not exceed the minimally clinically important difference.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Martínez-Catalán', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Hospital Universitario Fundación Jiménez Diaz, FJD Health Research Institute, Madrid, Spain. Electronic address: natalia.martinezcat@gmail.com.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Pajares', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Hospital Universitario Fundación Jiménez Diaz, FJD Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Llanos', 'Affiliation': 'Clinical Research Unit, Hospital Universitario Fundación Jiménez Diaz, FJD Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Mahillo', 'Affiliation': 'Department of Statistics, Hospital Universitario Fundación Jiménez Diaz, FJD Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': 'Department of Orthopaedic Surgery and Traumatology, Hospital Universitario Fundación Jiménez Diaz, FJD Health Research Institute, Madrid, Spain.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2020.05.013']
1705,32720188,Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage Among Adolescent Girls: Results from an Exploratory Study Nested Within a Cluster-Randomised Controlled Trial in India.,"We evaluated the impact of Samata, a 3-year multilayered intervention among scheduled caste/scheduled tribe (SC/ST) adolescent girls in rural northern Karnataka, on family-level (parents or guardian) attitudes and direct and indirect norms related to child marriage and girl's education. Endline data from 1840 family members were used to assess the effect of Samata on attitudes and norms related to schooling and child marriage, while data from 4097 family members (including 2257 family members at baseline) were used to understand the shifts in attitudes and norms over the period 2014-2017. Overall, we found that the programme had little impact on family-level attitudes and norms. However, there were shifts in some attitudes, norms and perceived sanctions between baseline (when girls were aged 13-14 years) and endline (when girls were aged 15-16 years), with some becoming more progressive (e.g. direct norms related to child marriage) and others more restrictive (e.g. norms around girls completing secondary education and norms related to child marriage and educational drop-out, blaming girls for eve teasing and limiting girls' mobility so as to protect family honour). Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting. Norms hypothesised to be important for marriage and schooling outcomes were indeed associated with these outcomes, but the intervention was not able to significantly shift these norms. In part, this may have been due to the intervention focusing much of its initial efforts on working with girls alone rather than family members, the relevant reference group. Future interventions that seek to affect norms should conduct formative research to clarify the specific norms affecting the outcome(s) of interest; likewise, programme planners should ensure that all activities engage those most influential in enforcing the norm(s) from the beginning. ClinicalTrials.gov registration number: NCT01996241.",2020,"Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting.","['Adolescent Girls', ""girls were aged 13-14\xa0years) and endline (when girls were aged 15-16\xa0years), with some becoming more progressive (e.g. direct norms related to child marriage) and others more restrictive (e.g. norms around girls completing secondary education and norms related to child marriage and educational drop-out, blaming girls for eve teasing and limiting girls' mobility so as to protect family honour"", '4097 family members (including 2257 family members at baseline', '1840 family members', ""scheduled caste/scheduled tribe (SC/ST) adolescent girls in rural northern Karnataka, on family-level (parents or guardian) attitudes and direct and indirect norms related to child marriage and girl's education""]",[],['Changes in Family-Level Attitudes and Norms and Association with Secondary School Completion and Child Marriage'],"[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007337', 'cui_str': 'Caste'}, {'cui': 'C0040881', 'cui_str': 'Tribes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}]",,0.028237,"Moreover, non-progressive norms related to marriage and education were strongly associated with child marriage and secondary school non-completion among adolescent girls in this rural setting.","[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Prakash', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada. ravi.prakash@ihat.in.'}, {'ForeName': 'Tara S', 'Initials': 'TS', 'LastName': 'Beattie', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Beniamino', 'Initials': 'B', 'LastName': 'Cislaghi', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Parinita', 'Initials': 'P', 'LastName': 'Bhattacharjee', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Javalkar', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), Bangalore, India.'}, {'ForeName': 'Satyanarayana', 'Initials': 'S', 'LastName': 'Ramanaik', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), Bangalore, India.'}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Thalinja', 'Affiliation': 'Karnataka Health Promotion Trust (KHPT), Bangalore, India.'}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Davey', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Mitzy', 'Initials': 'M', 'LastName': 'Gafos', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Watts', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Collumbien', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Moses', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada.'}, {'ForeName': 'Shajy', 'Initials': 'S', 'LastName': 'Isac', 'Affiliation': 'Department of Community Health Sciences, Institute for Global Public Health, University of Manitoba, R070 Med Rehab Bldg, 771 McDermot Avenue, Winnipeg, Manitoba, R3E 0T6, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Heise', 'Affiliation': 'Departments of Global Health and Development and Public Health, Environments and Society, London School of Hygiene & Tropical Medicine (LSHTM), 15-17 Tavistock Place, London, UK.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01143-1']
1706,32720190,Effects of Therapeutic Intervention on Parentally Bereaved Children's Emotion Reactivity and Regulation 15 Years Later.,"The Family Bereavement Program (FBP) is a family-based intervention for parentally bereaved children and surviving caregivers. Results are reported of a randomized controlled trial, examining intervention effects on emotional reactivity and regulation of young adults who participated in the program 15 years earlier. Participants (N = 152) completed four emotion challenge tasks: reactivity to negative images, detached reappraisal while viewing negative images, positive reappraisal while viewing negative images, and reengagement with positive images. Outcomes included cardiac interbeat interval (IBI), pre-ejection period (PEP), and respiratory sinus arrhythmia (RSA) as well as self-reported emotional experience and regulation effectiveness. Direct intervention effects and effects mediated through improved parenting were estimated. Several significant effects were observed in primary analyses; however, none remained significant after correction for familywise Type I error. Parenting mediated FBP effects on IBI during negative reactivity (b = 15.04), and on RSA during positive reengagement (b = 0.35); the latter effect was accounted for by changes in breathing. Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00). Intervention and gender interacted in predicting self-reported negative emotion during the negative reactivity (b = 1.04) and positive reappraisal tasks (b = 1.31) such that intervention-condition men reported more negative emotions during those tasks. Although these findings should be considered preliminary given the limited power of the corrected statistical tests, they suggest long-term effects of family intervention following the death of a parent on offspring's emotional reactivity and regulation ability that should be pursued further in future research.",2020,Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00).,"['young adults who participated in the program 15\xa0years earlier', 'Participants (N\u2009=\u2009152) completed four', ""Parentally Bereaved Children's Emotion Reactivity and Regulation 15\xa0Years Later""]","['emotion challenge tasks: reactivity to negative images, detached reappraisal while viewing negative images, positive reappraisal while viewing negative images, and reengagement with positive images', 'Family Bereavement Program (FBP', 'Therapeutic Intervention']","['emotional reactivity and regulation', 'cardiac interbeat interval (IBI), pre-ejection period (PEP), and respiratory sinus arrhythmia (RSA) as well as self-reported emotional experience and regulation effectiveness', 'negative emotions', 'positive reappraisal tasks']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860659', 'cui_str': 'Aloof'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0425043', 'cui_str': 'Death of relative'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0336969', 'cui_str': 'Ejection'}, {'cui': 'C0003813', 'cui_str': 'Sinus arrhythmia'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0281621,Intervention condition was a direct predictor of self-reported detached reappraisal effectiveness (b = 1.00).,"[{'ForeName': 'Alexander F', 'Initials': 'AF', 'LastName': 'Danvers', 'Affiliation': 'Department of Psychology, University of Arizona, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Brandon G', 'Initials': 'BG', 'LastName': 'Scott', 'Affiliation': 'Department of Psychology, Montana State University, Culbertson Hall, 100, Bozeman, MT, 59717, USA.'}, {'ForeName': 'Michelle N', 'Initials': 'MN', 'LastName': 'Shiota', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA. lani.shiota@asu.edu.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}, {'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Wolchik', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}, {'ForeName': 'Irwin I', 'Initials': 'II', 'LastName': 'Sandler', 'Affiliation': 'Department of Psychology, Arizona State University, P.O. Box 871104, Tempe, AZ, 85287-1104, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01142-2']
1707,32721237,Prospective Clinical Trial Comparing Curettage and Cryosurgery to Curettage and Electrodesiccation in the Management of Minimally Invasive Basal and Squamous Cell Carcinomas [Formula: see text].,"BACKGROUND
Basal and squamous cell carcinomas represent the most common cancers in North America. Their management is an important issue.
OBJECTIVES
The evaluation of cure rates of minimally invasive cutaneous carcinomas with curettage-cryosurgery compared to curettage-electrodesiccation, as well as the assessment of the aesthetic appearance of scars.
METHODS
This prospective trial randomized 117 patients 1:1 to treatments of curettage-cryosurgery or curettage-electrodesiccation. They were then followed at 6, 12, 18, and 24 months.
RESULTS
At 12-month follow-up, only one (1/49) patient had a recurrence of cutaneous carcinoma in the curettage-cryosurgery group and none (0/43) in the curettage-electrodesiccation group. Farrington-Manning analysis with a 5% margin of error showed the non-inferiority of the first method ( P = .04). For the aesthetic appearance of scars after 12 months, better results with curettage-cryosurgery procedure has been observed, but this was not statistically significant ( P = .80 and P = .27 for evaluations of patients and clinicians respectively).
LIMITATIONS
This study was mainly limited by its small sample size.
CONCLUSION
We have demonstrated that curettage-cryosurgery compared to curettage-electrodesiccation for the treatment of minimally invasive carcinomas is noninferior (comparable) with regards to cure rates at 12-month follow-up. No significant difference has been demonstrated for the appearance of scars.",2020,Farrington-Manning analysis with a 5% margin of error showed the non-inferiority of the first method ( P = .04).,"['117 patients 1:1 to treatments of', 'Minimally Invasive Basal and Squamous Cell Carcinomas']","['curettage-cryosurgery or curettage-electrodesiccation', 'Curettage and Cryosurgery to Curettage and Electrodesiccation', 'curettage-electrodesiccation']","['cure rates', 'recurrence of cutaneous carcinoma', 'appearance of scars']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0010408', 'cui_str': 'Cryosurgery'}, {'cui': 'C0185056', 'cui_str': 'Electrodesiccation'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]",117.0,0.0283465,Farrington-Manning analysis with a 5% margin of error showed the non-inferiority of the first method ( P = .04).,"[{'ForeName': 'Suzel', 'Initials': 'S', 'LastName': 'Fournier', 'Affiliation': 'CHU de Quebec - Centre de Recherche Clinique et Évaluative en Oncologie, Quebec, QC, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Laroche', 'Affiliation': 'CHU de Quebec - Centre de Recherche Clinique et Évaluative en Oncologie, Quebec, QC, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Leblanc', 'Affiliation': '10012 Dr Georges-L.-Dumont University Hospital Centre, Moncton, NB, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Bourgeault', 'Affiliation': 'Clinique GTB, Gatineau, QC, Canada.'}, {'ForeName': 'Mahukpe Narcisse', 'Initials': 'MN', 'LastName': 'Ulrich Singbo', 'Affiliation': ""91452 CHU de Quebec - Centre Hospitalier de l'Universite Laval, Quebec, QC, Canada.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Turcotte', 'Affiliation': '266173689626611 Hôtel-Dieu de Levis, Levis, QC, Canada.'}, {'ForeName': 'Marie-Michèle', 'Initials': 'MM', 'LastName': 'Blouin', 'Affiliation': 'CHU de Quebec - Centre de Recherche Clinique et Évaluative en Oncologie, Quebec, QC, Canada.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Alain', 'Affiliation': 'CHU de Quebec - Centre de Recherche Clinique et Évaluative en Oncologie, Quebec, QC, Canada.'}]",Journal of cutaneous medicine and surgery,['10.1177/1203475420943258']
1708,32729820,"Pharmacokinetics, pharmacodynamics, and tolerability of JY09 in healthy Chinese subjects: A titrating, dose-escalating study.","OBJECTIVES
To evaluate the pharmacokinetics, pharmacodynamics, and tolerability of JY09, a long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, in healthy subjects.
MATERIALS AND METHODS
Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received subcutaneous JY09 or placebo according to a randomized, double-blind, placebo-controlled, single-center, dose-escalating phase I trial design. Blood samples were collected over a 42-day period, and JY09 in plasma was determined by an electrochemical luminescence method. For the pharmacodynamic evaluation, oral glucose tolerance tests (OGTTs) were conducted predose and on day 5 after the target dose, during which plasma glucose, insulin, C-peptide, and glucagon concentrations were analyzed. Tolerability was assessed using physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity.
RESULTS
In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC 0-inf and C max from 0.7 to 6.0 mg JY09. The half-life of JY09 was ~ 9.3 days, and the peak concentration was reached at ~ 60 - 72 hours. Following the OGTT, an increase in C-peptide concentration was observed after exposure to JY09 at the dose of 6.0 mg compared to the placebo group. JY09 was well tolerated in healthy Chinese subjects following a single dose of up to 6.0 mg. No symptomatic hypoglycemia was reported, and the most commonly observed adverse event was suppressed appetite, and its incidence was dose-dependent. Four subjects (13%) developed anti-JY09 antibodies.
CONCLUSION
JY09 has a long half-life of ~ 9.3 days, with an acceptable safety profile.",2020,"In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC 0-inf and C max from 0.7 to 6.0 mg JY09.","['Healthy subjects were enrolled into 5 cohorts (0.3, 0.7, 1.5, 3.0, and 6.0 mg JY09) and received', 'healthy Chinese subjects', 'healthy subjects']","['subcutaneous JY09 or placebo', 'placebo']","['symptomatic hypoglycemia', 'tolerated', 'plasma glucose, insulin, C-peptide, and glucagon concentrations', 'Blood samples', 'AUC 0-inf and C max', 'peak concentration', 'C-peptide concentration', 'pharmacokinetics, pharmacodynamics, and tolerability', 'physical examination and queries, vital sign measurements, laboratory analysis, and detection of immunogenicity', 'Tolerability', 'Pharmacokinetics, pharmacodynamics, and\xa0tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.236705,"In healthy Chinese subjects, JY09 exhibited a dose-dependent increase in AUC 0-inf and C max from 0.7 to 6.0 mg JY09.","[{'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Yuanxun', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Junyi', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Zuyi', 'Initials': 'Z', 'LastName': 'Weng', 'Affiliation': ''}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': ''}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203730']
1709,32726475,Effectiveness of Advance Care Planning Group Visits Among Older Adults in Primary Care.,"BACKGROUND
Group visits can support health behavior change and self-efficacy. In primary care, an advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement.
OBJECTIVE
To determine whether the ENgaging in Advance Care Planning Talks (ENACT) group visits intervention improves ACP documentation and readiness in older adults.
METHODS
This randomized clinical trial was conducted among geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019. Participants randomized to ENACT group visits (n = 55) participated in two 2-hour sessions with discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos). Participants randomized to the control arm (n = 55) received the Conversation Starter Kit and a Medical Durable Power of Attorney form by mail. The primary outcomes included presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR) at 6 months, and a secondary outcome was ACP readiness (validated four-item ACP Engagement Survey) at 6 months.
RESULTS
Participants were a mean of 77 years old, 60% female, and 79% white. At 6 months, 71% of ENACT participants had an advance directive in the EHR (26% higher) compared with 45% of control arm participants (P < .001). Similarly, 93% of ENACT participants had decision-maker documentation in the EHR (29% higher) compared with 73% in the control arm (P < .001). ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
CONCLUSION
An ACP group visit increased ACP documentation and readiness to engage in ACP behavior change. Primary care teams can explore implementation and adaptation of ACP group visits into routine care, as well as longer-term impact on patient health outcomes. J Am Geriatr Soc 68:2382-2389, 2020.",2020,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
","['geriatric primary care patients from the University of Colorado Hospital Seniors Clinic, Aurora, CO, from August 2017 to November 2019', 'Participants were a mean of 77\u2009years old, 60% female, and 79% white', 'older adults', 'Older Adults in Primary Care']","['discussions of ACP topics and use of ACP tools (i.e., Conversation Starter Kit, Medical Durable Power of Attorney form, and PREPARE videos', 'Conversation Starter Kit and a Medical Durable Power of Attorney form by mail', 'ENgaging in Advance Care Planning Talks (ENACT) group visits intervention', 'ACP', 'Advance Care Planning Group Visits', 'advance care planning (ACP) group visit may leverage group dynamics and peer mentorship to facilitate education and personal goal setting that result in ACP engagement', 'ENACT']","['readiness to engage in ACP', 'presence of ACP documents or medical decision-maker documentation in the electronic health record (EHR', 'decision-maker documentation', 'ACP documentation and readiness', 'ACP documentation and readiness to engage in ACP behavior change', 'advance directive in the EHR']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0586806', 'cui_str': 'Power of attorney observable'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0554244', 'cui_str': 'Maker'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}]",,0.0679267,"ENACT participants trended toward higher readiness to engage in ACP compared with control (4.56 vs 4.13; P = .16) at 6 months.
","[{'ForeName': 'Hillary D', 'Initials': 'HD', 'LastName': 'Lum', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Dukes', 'Affiliation': 'University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Daddato', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Juarez-Colunga', 'Affiliation': 'Division of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.'}, {'ForeName': 'Prajakta', 'Initials': 'P', 'LastName': 'Shanbhag', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Jean S', 'Initials': 'JS', 'LastName': 'Kutner', 'Affiliation': 'Division of General Internal Medicine , Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Cari R', 'Initials': 'CR', 'LastName': 'Levy', 'Affiliation': 'Denver-Seattle Center of Innovation for Veteran-Centered and Value Driven Care, Eastern Colorado Health Care System, Aurora, Colorado, USA.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatric Medicine, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16694']
1710,33230185,Periocular skin warming promotes body heat loss and sleep onset: a randomized placebo-controlled study.,"Periocular skin warming was reported to have favorable effects on subjective and objective sleep quality. We hypothesized that enhancing body heat loss by periocular skin warming would reduce sleep onset and improve sleep quality. Eighteen healthy volunteers were asked to maintain wakefulness with their eyes closed for 60 min after applying either a warming or sham eye mask, followed by a 60-min sleep period. Compared to the sham, periocular warming increased the distal skin temperature and distal-proximal skin temperature gradient only during the 30-min thermal manipulation period. In the subsequent sleep period, periocular warming facilitated sleep onset, increased stage 2 sleep and electroencephalographic delta activity during the first half of the sleep period relative to the sham. These results suggest that periocular skin warming may accelerate and deepen sleep by enhancing physiological heat loss via the distal skin, mimicking physiological conditions preceding habitual sleep.",2020,"Compared to the sham, periocular warming increased the distal skin temperature and distal-proximal skin temperature gradient only during the 30-min thermal manipulation period.",['Eighteen healthy volunteers'],"['Periocular skin warming', 'placebo']","['stage 2 sleep and electroencephalographic delta activity', 'distal skin temperature and distal-proximal skin temperature gradient', 'sleep onset and improve sleep quality', 'subjective and objective sleep quality']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",18.0,0.0171001,"Compared to the sham, periocular warming increased the distal skin temperature and distal-proximal skin temperature gradient only during the 30-min thermal manipulation period.","[{'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Ichiba', 'Affiliation': 'Personal Health Care Laboratory, Kao Corporation, 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan. ichiba.tomohisa@kao.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Department of Psychiatry, Nihon University School of Medicine, 30-1 Oyaguchi Kamicho, Itabashi-ku, Tokyo, 173-8610, Japan.'}, {'ForeName': 'Sayaka', 'Initials': 'S', 'LastName': 'Aritake-Okada', 'Affiliation': 'Faculty of Health and Social Services, Saitama Prefectural University, 820, Sannomiya, Koshigaya, Saitama, 343-8540, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Psychiatry, Nihon University School of Medicine, 30-1 Oyaguchi Kamicho, Itabashi-ku, Tokyo, 173-8610, Japan. uchiyama.makoto@nihon-u.ac.jp.'}]",Scientific reports,['10.1038/s41598-020-77192-x']
1711,32737973,Multimodal Balance Training Supported by Rhythmic Auditory Stimuli in Parkinson Disease: Effects in Freezers and Nonfreezers.,"OBJECTIVE
To fulfill the potential of nonpharmacological interventions for people with Parkinson disease (PD), individually tailored treatment is needed. Multimodal balance training supported by rhythmic auditory stimuli (RAS) can improve balance and gait in people with PD. The purpose of this study was to determine whether both freezers and nonfreezers benefit.
METHODS
A secondary analysis was conducted on a large randomized controlled trial that included 154 patients with PD (Hoehn & Yahr Stages 1-3 while ON-medication) who were assigned randomly to 3 groups: (1) multimodal balance training with RAS delivered by a metronome (RAS-supported multimodal balance training); (2) regular multimodal balance training without rhythmic auditory cues; and (3) a control intervention (involving an educational program). Training was performed for 5 weeks, twice per week. The primary outcome was the Mini-BESTest score directly after the training period. Assessments were performed by a single, masked assessor at baseline, directly postintervention, and after 1-month and 6-month follow-up. Outcomes were analyzed in 1 analysis, and the results were presented separately for freezers and nonfreezers with a linear mixed model, adjusted for baseline Mini-BESTest scores, Unified Parkinson's Disease Rating Scale scores, and levodopa equivalent dose.
RESULTS
In both freezers and nonfreezers, both RAS-supported multimodal training and regular training significantly improved the Mini-BESTest scores compared with baseline scores and with the control group scores. The improvement was larger for RAS-supported training compared with regular training, for both freezers and nonfreezers. Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
CONCLUSIONS
RAS-supported multimodal training is effective in improving balance performance in both freezers and nonfreezers.
IMPACT
Until this study, it was unknown whether both freezers and nonfreezers could benefit from multimodal balance training. With this information, clinicians who work with people with PD will be better able to apply personalized gait rehabilitation.
LAY SUMMARY
Adding rhythmic auditory stimuli (RAS) to balance training is beneficial for both freezers and nonfreezers, at least in persons with mild to moderate disease stages. This RAS-supported multimodal training has good potential for a wider clinical implementation with good long-term effects.",2020,"Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
","['154 patients with PD (Hoehn & Yahr Stages 1-3 while ON-medication', 'Parkinson Disease', 'Parkinson disease (PD']","['multimodal balance training with rhythmic auditory stimuli delivered by a metronome (RAS-supported multimodal balance training), (2) regular multimodal balance training without rhythmic auditory cues, and (3) a control intervention (involving an educational program', 'Multimodal balance training', 'Multimodal Balance Training', 'RAS-supported multimodal training']","['Mini-BESTest scores', 'balance performance', 'Mini-BESTest score directly', ""baseline Mini-BESTest scores, Unified Parkinson's Disease Rating Scale scores, and levodopa equivalent dose"", 'balance and gait in PD']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]",154.0,0.0633119,"Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers.
","[{'ForeName': 'Tamine T C', 'Initials': 'TTC', 'LastName': 'Capato', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center; Nijmegen, the Netherlands; and Movement Disorders Clinic, Department of Neurology, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nienke M', 'Initials': 'NM', 'LastName': 'de Vries', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center.'}, {'ForeName': 'Jordache', 'Initials': 'J', 'LastName': 'Ramjith', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Clinic, Department of Neurology, University of São Paulo.'}, {'ForeName': 'Jorik', 'Initials': 'J', 'LastName': 'Nonnekes', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center; and Department of Rehabilitation, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'Bastiaan R', 'Initials': 'BR', 'LastName': 'Bloem', 'Affiliation': 'Donders Institute for Brain, Cognition and Behaviour, Department of Neurology, and Center of Expertise for Parkinson & Movement Disorders, Radboud University Medical Center.'}]",Physical therapy,['10.1093/ptj/pzaa146']
1712,32738130,"Influence of concurrent capecitabine based chemoradiotherapy with bevacizumab on the survival rate, late toxicity and health-related quality of life in locally advanced rectal cancer: a prospective phase II CRAB trial.","Background Few studies reported early results on efficacy, toxicity of combined modality treatment for locally advanced rectal cancer (LARC) by adding bevacizumab to preoperative chemoradiotherapy, but long-term data on survival, and late complications are lacking. Further, none of the studies reported on the assessment of quality of life (QOL). Patients and methods After more than 5 years of follow-up, we updated the results of our previous phase II trial in 61 patients with LARC treated with neoadjuvant capecitabine, radiotherapy and bevacizumab (CRAB study) before surgery and adjuvant chemotherapy. Secondary endpoints of updated analysis were local control (LC), disease free (DFS) and overall survival (OS), late toxicity and longitudinal health related QOL (before starting the treatment and one year after the treatment) with questionnaire EORTC QLQ-C30 and EORTC QLQ-CR38. Results Median follow-up was 67 months. During the follow-up period, 16 patients (26.7%) died. The 5-year OS, DFS and LC rate were 72.2%, 70% and 92.4%. Patients with pathological positive nodes or pathological T3-4 tumors had significantly worse survival than patients with pathological negative nodes or T0-2 tumors. Nine patients (14.8%) developed grade 33 late complications of combined modality treatment, first event 12 months and last 87 months after operation (median time 48 months). Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased. Based on QLQ-CR38 scores body image scores significantly increase, problems with weight loss significantly decrease, but sexual dysfunction in men and chemotherapy side effects significantly increase. Conclusions Patients with LARC and high risk factors, such as positive pathological lymph nodes and high pathological T stage, deserve more aggressive treatment in the light of improving long-term survival results. Patients after multimodality treatment should be given greater attention to the regulation of individual aspects of quality of life and the occurrence of late side effects.",2020,"Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased.","['61 patients with LARC treated with', 'locally advanced rectal cancer (LARC', 'locally advanced rectal cancer', 'Patients with pathological positive nodes or pathological T3-4 tumors']","['neoadjuvant capecitabine, radiotherapy and bevacizumab (CRAB study) before surgery and adjuvant chemotherapy', 'capecitabine based chemoradiotherapy with bevacizumab', 'bevacizumab']","['5-year OS, DFS and LC rate', 'grade 33 late complications', 'local control (LC), disease free (DFS) and overall survival (OS), late toxicity and longitudinal health related QOL', 'questionnaire EORTC QLQ-C30 and EORTC QLQ-CR38', 'survival', 'physical and social functioning', 'quality of life (QOL', 'efficacy, toxicity', 'QLQ-CR38 scores body image scores', 'sexual dysfunction', 'global QOL and three symptoms (pain, insomnia and diarrhea', 'survival rate, late toxicity and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0010260', 'cui_str': 'Infraorder Brachyura'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",61.0,0.0636662,"Based on EORTC QLQ-C30 scores one year after treatment there were no significant changes in global QOL and three symptoms (pain, insomnia and diarrhea), but physical and social functioning significantly decreased.","[{'ForeName': 'Vaneja', 'Initials': 'V', 'LastName': 'Velenik', 'Affiliation': 'Division of Radiotherapy, Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Zadnik', 'Affiliation': 'Division of Epidemiology, Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Omejc', 'Affiliation': 'Division of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Grosek', 'Affiliation': 'Division of Surgery, University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Mojca', 'Initials': 'M', 'LastName': 'Tuta', 'Affiliation': 'Division of Radiology, Institute of Oncology, Ljubljana, Slovenia.'}]",Radiology and oncology,['10.2478/raon-2020-0043']
1713,32743813,Local prolonged release of antibiotic for prevention of sternal wound infections postcardiac surgery-A novel technology.,"INTRODUCTION
Sternal wound infection (SWI) is a devastating postcardiac surgical complication. D-PLEX 100 (D-PLEX) is a localized prolonged release compound applied as a prophylactic at the completion of surgery to prevent SWI. The D-PLEX technology platform is built as a matrix of alternating layers of polymers and lipids, entrapping an antibiotic (doxycycline). The objective of this study was to assess the safety profile and pharmacokinetics of D-PLEX in reducing SWI rates postcardiac surgery.
METHOD
Eighty-one patients were enrolled in a prospective single-blind randomized controlled multicenter study. Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone. Both groups were followed 6 months for safety endpoints. SWI was assessed at 90 days.
RESULTS
No SWI-related serious adverse events (SAEs) occurred in either group. The mean plasma C max in patients treated with D-PLEX was about 10 times lower than the value detected following the oral administration of doxycycline hyclate with an equivalent overall dose, and followed by a very low plasma concentration over the next 30 days. There were no sternal infections in the D-PLEX group (0/60) while there was one patient with a sternal infection in the control group (1/21, 4.8%).
CONCLUSION
D-PLEX was found to be safe for use in cardiac surgery patients. By providing localized prophylactic prolonged release of broad-spectrum antibiotics, D-PLEX has the potential to prevent SWI postcardiac surgery and long-term postoperative hospitalization, reducing high-treatment costs, morbidity, and mortality.",2020,"RESULTS
No SWI-related serious adverse events (SAEs) occurred in either group.","['cardiac surgery patients', 'Eighty-one patients', 'Sixty patients were treated with both D-PLEX and standard of care (SOC) and 21 with SOC alone']","['doxycycline', 'D-PLEX', 'antibiotic (doxycycline']","['sternal infection', 'sternal infections', 'mean plasma C max', 'SWI', 'serious adverse events (SAEs']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",60.0,0.0487843,"RESULTS
No SWI-related serious adverse events (SAEs) occurred in either group.","[{'ForeName': 'Erez', 'Initials': 'E', 'LastName': 'Kachel', 'Affiliation': 'Department of Cardiac Surgery, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Moshkovitz', 'Affiliation': 'Department of Cardiothoracic Surgery, Assuta Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Sternik', 'Affiliation': 'Department of Cardiac Surgery, Sheba Medical Centre, Tel Hashomer, Israel.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Sahar', 'Affiliation': 'Department of Cardiothoracic Surgery, Soroka Medical Center, Beer Sheva, Israel.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'Grosman-Rimon', 'Affiliation': 'Department of Cardiac Surgery, Poriya Medical Center, Tiberias, Israel.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Belotserkovsky', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Malka', 'Initials': 'M', 'LastName': 'Reichart', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Yafit', 'Initials': 'Y', 'LastName': 'Stark', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Emanuel', 'Affiliation': 'PolyPid Ltd, Petach-Tikva, Israel.'}]",Journal of cardiac surgery,['10.1111/jocs.14890']
1714,32757413,Non-Motor Symptoms in Parkinson's Disease are Reduced by Nabilone.,"OBJECTIVE
The objective of this study was to assess the efficacy and safety of nabilone, a synthetic tetrahydrocannabinol analogue, as a treatment for non-motor symptoms (NMS) in Parkinson's disease (PD).
METHODS
This was a phase II placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal trial conducted at the Medical University Innsbruck. A random sample of 47 patients with PD with stable motor disease and disturbing NMS defined by a score of ≥4 points on the Movement Disorder Society - Unified PD Rating Scale-I (MDS-UPDRS-I) underwent open-label nabilone titration (0.25 mg once daily to 1 mg twice daily, phase I). Responders were randomized 1:1 to continue with nabilone or switch to placebo for 4 weeks (phase II). The primary efficacy criterion was the change of the MDS-UPDRS-I between randomization and week 4. Safety was analyzed in all patients who received at least one nabilone dose.
RESULTS
Between October 2017 and July 2019, 19 patients received either nabilone (median dose = 0.75 mg) or placebo. At week 4, mean change of the MDS-UPDRS-I was 2.63 (95% confidence interval [CI] 1.53 to 3.74, p = 0.002, effect size = 1.15) in the placebo versus 1.00 (95% CI -0.16 to 2.16, p = 0.280, effect size = 0.42) in the nabilone-group (difference: 1.63, 95% CI 0.09 to 3.18, p = 0.030, effect size = 0.66). Seventy-seven percent of patients had adverse events (AEs) during open-label titration, most of them were transient. In the double-blind phase, similar proportions of patients in each group had AEs (42% in the placebo group and 32% in the nabilone group). There were no serious AEs.
INTERPRETATION
Our results highlight the potential efficacy of nabilone for patients with PD with disturbing NMS, which appears to be driven by positive effects on anxious mood and night-time sleep problems.
TRIAL REGISTRY
ClinicalTrials.gov (NCT03769896) and EudraCT (2017-000192-86). ANN NEUROL 2020;88:712-722.",2020,"I was 2.63 (95%CI 1.53-3.74, p=0.002, effect","['Between October 2017 and July 2019', '47 PD patients with stable motor disease and disturbing NMS defined by a score of ≥4 points on the Movement Disorder Society-Unified PD Rating Scale-I (MDS-UPDRS-I) underwent', '2017-000192-86', 'non-motor symptoms (NMS) in Parkinson´s Disease (PD']","['nabilone or switch to placebo', 'open-label nabilone titration', 'EudraCT', 'placebo']","['Safety', 'effect', 'mean change of the MDS-UPDRS', 'adverse events (AEs', 'change of the MDS-UPDRS']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]","[{'cui': 'C0068333', 'cui_str': 'nabilone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.706771,"I was 2.63 (95%CI 1.53-3.74, p=0.002, effect","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Peball', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krismer', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Hans-Günther', 'Initials': 'HG', 'LastName': 'Knaus', 'Affiliation': 'Department for Medical Genetics, Molecular, and Clinical Pharmacology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Atbin', 'Initials': 'A', 'LastName': 'Djamshidian', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Werkmann', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Carbone', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ellmerer', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Heim', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Marini', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Valent', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Goebel', 'Affiliation': 'Department of Medical Statistics, Informatics, and Health Economics, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Ulmer', 'Affiliation': 'Department of Medical Statistics, Informatics, and Health Economics, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Stockner', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Gregor K', 'Initials': 'GK', 'LastName': 'Wenning', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Raphaela', 'Initials': 'R', 'LastName': 'Stolz', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Krejcy', 'Affiliation': 'AOP Orphan Pharmaceuticals AG, Vienna, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Seppi', 'Affiliation': 'Department of Neurology, Innsbruck Medical University, Innsbruck, Austria.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of neurology,['10.1002/ana.25864']
1715,32762271,Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.,"We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p ( n = 578) were randomized 1:1 to 420 mg daily ibrutinib or placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone. Median follow-up was 63.7 months. Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229 [95% confidence interval (CI) 0.183-0.286]; p < .0001). Despite crossover of 63.3% of patients from the placebo plus BR arm to ibrutinib treatment upon disease progression, ibrutinib plus BR versus placebo plus BR demonstrated an overall survival benefit (HR 0.611 [95% CI 0.455-0.822]; p = .0010; median not reached in either arm). Long-term follow-up data confirm the survival benefit of ibrutinib plus BR over BR alone. Safety profiles were consistent with those known for ibrutinib and BR.",2020,Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229,"['patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma', 'Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p ( n \u2009=\u2009578']","['placebo plus ≤6 cycles of bendamustine plus rituximab (BR), followed by ibrutinib or placebo alone', 'bendamustine and rituximab', 'placebo']","['survival benefit', 'Median investigator-assessed progression-free survival', 'overall survival benefit']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0278791', 'cui_str': 'Chronic lymphocytic leukaemia refractory'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",578.0,0.538994,Median investigator-assessed progression-free survival was longer with ibrutinib plus BR (65.1 months) than placebo plus BR (14.3 months; hazard ratio [HR] 0.229,"[{'ForeName': 'Graeme A M', 'Initials': 'GAM', 'LastName': 'Fraser', 'Affiliation': 'Juravinski Cancer Centre, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Asher', 'Initials': 'A', 'LastName': 'Chanan-Khan', 'Affiliation': 'Division of Hematology, Mayo Clinic Cancer Center, Jacksonville, FL, USA.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Demirkan', 'Affiliation': 'Division of Hematology, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Santucci Silva', 'Affiliation': 'IEP São Lucas/Hemomed Oncologia e Hematologia, São Paulo, Brazil.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Grosicki', 'Affiliation': 'Department of Hematology and Cancer Prevention, School of Public Health, Silesian Medical University, Katowice, Poland.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Universitaire Ziekenhuizen Leuven, Leuven, Belgium.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Jihlavska, Brno, Czech Republic.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Siteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Marie-Sarah', 'Initials': 'MS', 'LastName': 'Dilhuydy', 'Affiliation': 'Hopital Haut Leveque, Bordeaux, France.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Loscertales', 'Affiliation': 'Hematology Department, Hospital Universitario La Princesa, IIS-IP, Madrid, Spain.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Avigdor', 'Affiliation': 'Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer and Sackler School of Medicine, University of Tel-Aviv, Tel-Aviv, Israel.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rule', 'Affiliation': 'Department of Haematology, University of Plymouth Medical School, Plymouth, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Samoilova', 'Affiliation': 'Nizhny Novogorod Regional Clinical Hospital, Nizhny Novogorod, Russia.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Pavlovsky', 'Affiliation': 'Department of Hematology, Fundaleu, Buenos Aires, Argentina.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Goy', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Mato', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine and German CLL Study Group, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Salman', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Monelle', 'Initials': 'M', 'LastName': 'Tamegnon', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Connor', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Nottage', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Schuier', 'Affiliation': 'Janssen-Cilag, Neuss, Germany.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Balasubramanian', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Howes', 'Affiliation': 'Janssen Research & Development, High Wycombe, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': 'Department I of Internal Medicine and German CLL Study Group, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}]",Leukemia & lymphoma,['10.1080/10428194.2020.1795159']
1716,32763112,Examining the effect of a mindfulness based program for the improvement of cognitive function in an early stage of schizophrenia. A random controlled trial.,,2020,,['early stage of schizophrenia'],['mindfulness based program'],['cognitive function'],"[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0225595,,"[{'ForeName': 'Álvaro I', 'Initials': 'ÁI', 'LastName': 'Langer', 'Affiliation': 'Mind-Body Lab, Instituto de Estudios Psicológicos, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile; Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile; Millennium Institute for Research in Depression and Personality (MIDAP), Santiago, Chile; Center for Interdisciplinary Studies on the Nervous System (CISNe), Universidad Austral de Chile, Valdivia, Chile. Electronic address: alvaro.langer@uach.cl.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'Millennium Institute for Research in Depression and Personality (MIDAP), Santiago, Chile; Brain, Cognition and Behavior PhD Program, University of Barcelona, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Vergara', 'Affiliation': 'Departamento de Kinesiología, Facultad de Artes y Educación Física, Universidad Metropolitana de Ciencias de la Educación, Chile.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Mayol-Troncoso', 'Affiliation': 'Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile; Clínica Psiquiátrica Universitaria, Hospital Clínico y Facultad de Medicina, Universidad de Chile, Chile.'}, {'ForeName': 'Javiera', 'Initials': 'J', 'LastName': 'Lecaros', 'Affiliation': 'Escuela de Psicología, Universidad Adolfo Ibáñez, Chile.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Krogh', 'Affiliation': 'Mind-Body Lab, Instituto de Neurociencias Clínicas, Facultad de Medicina, Universidad Austral de Chile, Chile.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vergara', 'Affiliation': 'Servicio de Psiquiatría y Salud Mental Hospital El Pino, San Bernardo, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Díaz', 'Affiliation': 'Clínica Psiquiátrica Universitaria, Hospital Clínico y Facultad de Medicina, Universidad de Chile, Chile.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Rivera', 'Affiliation': 'Mind-Body Lab, Instituto de Estudios Psicológicos, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile; Mind-Body Lab, Instituto de Neurociencias Clínicas, Facultad de Medicina, Universidad Austral de Chile, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Aguirre-Baez', 'Affiliation': 'Mind-Body Lab, Instituto de Estudios Psicológicos, Facultad de Medicina, Universidad Austral de Chile, Valdivia, Chile.'}, {'ForeName': 'Pablo A', 'Initials': 'PA', 'LastName': 'Gaspar', 'Affiliation': 'Millennium Nucleus to Improve the Mental Health of Adolescents and Youths (Imhay), Santiago, Chile; Clínica Psiquiátrica Universitaria, Hospital Clínico y Facultad de Medicina, Universidad de Chile, Chile; Clínica Alemana de Santiago, RM, Chile; Instituto Milenio de Neurociencias, BNI, RM, Chile.'}]",Schizophrenia research,['10.1016/j.schres.2020.07.012']
1717,32717846,"The Sustainability and Scalability of Private Sector Sanitation Delivery in Urban Informal Settlement Schools: A Mixed Methods Follow Up of a Randomized Trial in Nairobi, Kenya.","There are considerable challenges to achieving the Sustainable Development Goals' target of universal access to basic sanitation in schools. Schools require safe, clean, and sex-segregated facilities for a large number of students. Robust and affordable solutions are needed to address the economic, spatial, social, institutional, and political factors which contribute to poor sanitary conditions in informal settlements. In 2015, we undertook a randomized controlled trial to assess the feasibility of private sector sanitation delivery (PSSD) in 20 primary schools, in informal settlements of Nairobi, Kenya. Our preliminary evaluation after one year of service delivery suggested that PSSD of urine-diverting dry latrines with routine waste collection and maintenance provided a feasible, lower-cost alternative to the government standard delivery (GSD) of cistern-flush toilets or ventilated improved pit latrines. We conducted a mixed-methods follow-up study to assess sanitation delivery over 3-4 years and investigate prevailing drivers and barriers that may influence the scalability of PSSD. The conditions of newly constructed and rehabilitated GSD facilities diminished quickly, reverting to the conditions of existing facilities, indicating lower sustainability compared to sanitation delivered from the private sector. Barriers in financial aspects related to the ongoing implementation of PSSD emerged, particularly among public schools, and few were able to pay for continued service. Our study demonstrates that the engagement of the private sector may lead to improvements in affordable, safely managed sanitation for schools and their students. Yet, to reach a sustained scale, additional guidance is needed on how to develop these partnerships, streamline procurement and contracting processes, and incorporate appropriate financing mechanisms.",2020,"Our study demonstrates that the engagement of the private sector may lead to improvements in affordable, safely managed sanitation for schools and their students.","['Urban Informal Settlement Schools', '20 primary schools, in informal settlements of Nairobi, Kenya']",['private sector sanitation delivery (PSSD'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0027345', 'cui_str': 'Nairobi sheep virus disease'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C0033176', 'cui_str': 'Private Sector'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],,0.0218354,"Our study demonstrates that the engagement of the private sector may lead to improvements in affordable, safely managed sanitation for schools and their students.","[{'ForeName': 'Jedidiah S', 'Initials': 'JS', 'LastName': 'Snyder', 'Affiliation': 'Gangarosa Department of Environmental Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Prentice-Mott', 'Affiliation': 'Gangarosa Department of Environmental Health, Emory University, Atlanta, GA 30322, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Boera', 'Affiliation': 'Consultant, Nairobi 00100, Kenya.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mwaki', 'Affiliation': 'Safe Water & AIDS Project, Kisumu 40100, Kenya.'}, {'ForeName': 'Kelly T', 'Initials': 'KT', 'LastName': 'Alexander', 'Affiliation': 'CARE, Atlanta, GA 30307, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Freeman', 'Affiliation': 'Gangarosa Department of Environmental Health, Emory University, Atlanta, GA 30322, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17155298']
1718,32717868,Assessment of Attitudes Toward Physical Education by the Implementation of an Extracurricular Program for Obese Children.,"The World Health Organization (WHO) identifies the importance of implementing physical activity programs such as physical education (PE) classes in schools. This study identifies the attitudes of obese children toward PE, before and after participation in a vigorous-intensity physical exercise program without the participation of normal-weight peers using a questionnaire on Attitudes toward Physical Education (CAEF). 98 children between 8-11 years of age were randomized in an Experimental Group (GE) ( n = 48) and a Control Group (CG) ( n = 47). They were assessed using a questionnaire on Attitudes toward Physical Education (CAEF). All the study participants exhibited a BMI Z-score ≥ 2. Before the intervention, the only difference between boys and girls was ""empathy to teacher and physical education subject"" ( p = 0.001, d de Cohen = 0.72, r = 0.34). The interaction between gender and training was only present in empathy for the teacher, with a medium effect size ( η 2 = 0.055). The implementation of PE with two hours per week elicits only a few effects over the attitude of obese children, even though with a certain engagement of gender through training in the adjustment of empathy for teachers and the PE class.",2020,"Before the intervention, the only difference between boys and girls was ""empathy to teacher and physical education subject"" ( p = 0.001, d de Cohen =","['Obese Children', '98 children between 8-11 years of age']","['vigorous-intensity physical exercise program', 'Control Group (CG']","['Attitudes toward Physical Education (CAEF', 'empathy to teacher and physical education subject']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}]",98.0,0.017797,"Before the intervention, the only difference between boys and girls was ""empathy to teacher and physical education subject"" ( p = 0.001, d de Cohen =","[{'ForeName': 'Ena Monserrat', 'Initials': 'EM', 'LastName': 'Romero-Pérez', 'Affiliation': 'Division of Biological Sciences and Health, University of Sonora, 83000 Hermosillo, Sonora, Mexico.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Núñez Enríquez', 'Affiliation': 'Faculty of Physical Culture Sciences, Autonomous University of Chihuahua, 31000 Chihuahua, Chih, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gastélum-Cuadras', 'Affiliation': 'Faculty of Physical Culture Sciences, Autonomous University of Chihuahua, 31000 Chihuahua, Chih, Mexico.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Horta-Gim', 'Affiliation': 'Division of Biological Sciences and Health, University of Sonora, 83000 Hermosillo, Sonora, Mexico.'}, {'ForeName': 'Jerónimo J', 'Initials': 'JJ', 'LastName': 'González-Bernal', 'Affiliation': 'Department of Health Sciences, University of Burgos, 09001 Burgos, Spain.'}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'de Paz', 'Affiliation': 'Division of Biological Sciences and Health, University of Sonora, 83000 Hermosillo, Sonora, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17155300']
1719,32717926,The Effects of Alcohol Consumption on Cardiometabolic Health Outcomes Following Weight Loss in Premenopausal Women with Obesity: A Pilot Randomized Controlled Trial.,"Alcohol (i.e., ethanol) is consumed regularly by much of the adult population; yet, the health effects associated with its use are not well-characterized. Clinical interventions to investigate the effects of moderate alcohol consumption on metabolic outcomes, including adiposity and cardiovascular risk factors, are limited and have yielded conflicting data. In addition, no study has reported the effects of routine alcohol intake during weight loss in a controlled feeding trial. We present the first randomized controlled pilot trial to investigate the effects of moderate alcohol consumption on metabolic outcomes during weight loss in women with obesity. Both groups consumed 30% energy restricted diets and were randomized to either an ethanol-free control (CTL) group or a group (EtOH) that consumed 35 g ethanol daily for eight weeks. Our findings demonstrate that, despite similar weight loss, the decrease in mean arterial pressure was attenuated in the EtOH group, relative to the CTL group ( p = 0.02). In addition, decreases in other outcomes, including visceral adipose tissue ( p = 0.23), circulating lipids (triglycerides ( p = 0.11) and cholesterol ( p = 0.11)), and uric acid ( p = 0.07) tended to be attenuated with alcohol consumption. These pilot data provide potential evidence that moderate alcohol consumption may mitigate the beneficial effects of weight loss and support the need for larger Randomized Controlled Trials (RCTs) to better investigate the metabolic effects of moderate alcohol intake in humans.",2020,"In addition, decreases in other outcomes, including visceral adipose tissue ( p = 0.23), circulating lipids (triglycerides ( p = 0.11) and cholesterol ( p = 0.11)), and uric acid ( p = 0.07) tended to be attenuated with alcohol consumption.","['Premenopausal Women with Obesity', 'women with obesity']","['ethanol-free control (CTL', 'moderate alcohol consumption', 'Alcohol Consumption', 'Alcohol (i.e., ethanol']","['visceral adipose tissue', 'circulating lipids (triglycerides', 'Cardiometabolic Health Outcomes', 'uric acid', 'mean arterial pressure', 'weight loss', 'adiposity and cardiovascular risk factors']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.0546005,"In addition, decreases in other outcomes, including visceral adipose tissue ( p = 0.23), circulating lipids (triglycerides ( p = 0.11) and cholesterol ( p = 0.11)), and uric acid ( p = 0.07) tended to be attenuated with alcohol consumption.","[{'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'White', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA 70808, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17155302']
1720,32720362,Outcomes of left ventricular assist device implantation in hypercoagulable patients.,"BACKGROUND
The aim of this study was to evaluate outcomes of left ventricular assist devices (LVADs) in patients who tested positive for hypercoagulable hematologic disorders.
METHODS
Adults undergoing continuous-flow LVAD implantation with preoperative hypercoagulability testing between 2004 and 2018 at a single center were reviewed. Hypercoagulability was defined as testing positive for antiphospholipid antibody, anticardiolipin antibody, lupus anticoagulant, protein C, protein S, factor V Leiden, and/or heparin-induced thrombocytopenia. The primary outcome was survival on the original LVAD. Secondary outcomes included rates of thromboembolic complications and readmission for intravenous heparin treatment.
RESULTS
A total of 270 LVAD patients with pre-implant hypercoagulability testing were included, and 157 (58%) tested positive for a hypercoagulable disorder. Of those testing positive, 10 (6.4%) had a clinical pre-LVAD history of thromboembolic events. Survival was comparable between hypercoagulable and non-hypercoagulable patients (1 year: 73.3% vs 78.9%, P = .2195, 2-year: 60.7% vs 62.8%, P = .3627). Rates of pump thrombosis (14.0% vs 13.3%, P = .8618), hemolysis (4.5% vs 3.5%, P = .3536), stroke (18.5% vs 14.2%, P = .3483) and readmission for IV heparin therapy (87.3% (n = 137) vs 77.9% (n = 88), P = .7560) were similar. Outcomes were comparable in patients with positive hypercoagulable tests when stratified by pre-implant clinical history of hypercoagulability as well as stratified by recent preoperative exposure to heparin or warfarin.
CONCLUSIONS
In this series, positive laboratory tests for hypercoagulability were common amongst patients undergoing LVAD implantation although few had positive clinical histories. Survival and freedom from thromboembolic complications were comparable to non-hypercoagulable patients. Hypercoagulability alone should therefore not serve as a contraindication to LVAD implantation.",2020,"Rates of pump thrombosis (14.0% vs 13.3%, P = .8618), hemolysis (4.5% vs 3.5%, P = .3536), stroke (18.5% vs 14.2%, P = .3483) and readmission for IV heparin therapy (87.3% (n = 137) vs 77.9% (n = 88), P = .7560) were similar.","['270 LVAD patients with pre-implant hypercoagulability testing were included, and 157 (58%) tested positive for a hypercoagulable disorder', 'patients who tested positive for hypercoagulable hematologic disorders', 'Adults undergoing continuous-flow LVAD implantation with preoperative hypercoagulability testing between 2004 and 2018 at a single center were reviewed', 'hypercoagulable patients']","['left ventricular assist device implantation', 'heparin or warfarin', 'left ventricular assist devices (LVADs']","['clinical pre-LVAD history of thromboembolic events', 'survival on the original LVAD', 'Survival and freedom from thromboembolic complications', 'Survival', 'stroke', 'rates of thromboembolic complications and readmission for intravenous heparin treatment', 'hemolysis', 'Hypercoagulability', 'Rates of pump thrombosis']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0398623', 'cui_str': 'Thrombophilia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",270.0,0.227396,"Rates of pump thrombosis (14.0% vs 13.3%, P = .8618), hemolysis (4.5% vs 3.5%, P = .3536), stroke (18.5% vs 14.2%, P = .3483) and readmission for IV heparin therapy (87.3% (n = 137) vs 77.9% (n = 88), P = .7560) were similar.","[{'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Dufendach', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Seese', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Stearns', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mathier', 'Affiliation': 'Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Keebler', 'Affiliation': 'Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Shangzhen', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Sciortino', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Floyd W', 'Initials': 'FW', 'LastName': 'Thoma', 'Affiliation': 'Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Kilic', 'Affiliation': 'Division of Cardiac Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}]",Journal of cardiac surgery,['10.1111/jocs.14710']
1721,32720367,Comparison of pleural effusion between fenestrated and nonfenestrated extracardiac Fontan: A prospective randomized study.,"BACKGROUND
Fenestration of the baffle/conduit is believed to reduce pleural effusion following the Fontan operation. However, equivocal results have been observed with or without fenestration. This study aims to evaluate the efficacy of fenestration on the amount and duration of pleural effusion following the Fontan operation.
METHODS
About 40 patients undergoing extracardiac Fontan (ECF) were randomized into two groups: one with fenestration (ECF-F; n = 20) or without fenestration (ECF-NF; n = 20). Primary outcome was the amount and duration of pleural effusions. Secondary outcomes were time to removal of the chest tubes, hospital stay, and readmission to the hospital because of recurrent pleural within 30 days of the operation.
RESULTS
Mean age was 11.5 ± 5.07 (range, 8.7-13.5) years in the ECF-F group and 13.6 ± 0.4 years (range, 10.5-15.5) in the (ECF-NF) group. The total drain output was 7.89 mL/kg/d in ECF-NF compared with 6.9 mL/kg/d in the ECF-group (P = .14). Time for removal of pleural tubes was 14.6 ± 0.95 days in the ECF-NF group compared with 11.6 ± days in the ECF-F group. Total duration of hospital stay was higher but not significant in the ECF-NF group compared with the ECF-F group. Two patients in ECF-NF required readmission to the hospital within 30 days following discharge, while there were no readmissions in the ECF-F group.
CONCLUSION
Contrary to the literature, the creation of a fenestration in the ECF circuit was not clearly associated with a reduction in the amount and duration of pleural effusion compared with a non-fenestrated Fontan. These findings may be debatable in high risks versus low risk candidates. However in the present study, in a low risk canditates undergoing the Fontan operation, the daily amount of pleural drainage was no different. Larger studies are needed to confirm these findings.",2020,Total duration of hospital stay was higher but not significant in the ECF-NF group compared with the ECF-F group.,"['Mean age was 11.5\u2009±\u20095.07 (range, 8.7-13.5) years in the ECF-F group and 13.6\u2009±\u20090.4 years (range, 10.5-15.5) in the (ECF-NF) group', 'pleural effusion between fenestrated and nonfenestrated extracardiac Fontan', '40 patients undergoing extracardiac Fontan (ECF']",['fenestration (ECF-F; n\u2009=\u200920) or without fenestration (ECF-NF'],"['Time for removal of pleural tubes', 'amount and duration of pleural effusions', 'total drain output', 'time to removal of the chest tubes, hospital stay, and readmission to the hospital because of recurrent pleural within 30 days of the operation', 'Total duration of hospital stay']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4517880', 'cui_str': '8.7'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441840', 'cui_str': 'Group F'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015825', 'cui_str': 'Inner ear fenestration'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008034', 'cui_str': 'Chest drain'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",40.0,0.0456897,Total duration of hospital stay was higher but not significant in the ECF-NF group compared with the ECF-F group.,"[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Adarsh', 'Initials': 'A', 'LastName': 'Paidi', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Vishnubhatla', 'Initials': 'V', 'LastName': 'Sreeniwas', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Dutt Upadhyay', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sambhunath', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Shiv K', 'Initials': 'SK', 'LastName': 'Choudhary', 'Affiliation': 'Department of Biostatistics, Cardiothoracic Center, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of cardiac surgery,['10.1111/jocs.14886']
1722,32720457,Examining the interdependence of parent-child dyads: Effects on weight loss and maintenance.,"BACKGROUND
This study aimed to further elucidate correlated weight changes in parent-child dyads enrolled in family-based treatment (FBT) by modeling the interdependence of weight changes during treatment.
METHODS
Parent-child dyads (n = 172) with overweight/obesity (child mean zBMI = 2.16 ± 0.39; parent mean BMI = 37.9 ± 9.4 kg/m 2 ) completed 4 months of FBT and were randomized to one of three 8-month maintenance interventions (Social Facilitation Maintenance [SFM]-high dose, SFM-low dose or control). Weight/height was measured at 0, 4 and 12 months. Structural equation models simultaneously estimated the effect that an individual had on their own (actor effect) and on one another's (partner effect) weight-status across time using the actor-partner interdependence model.
RESULTS
Actor paths were significant over time for parent and child. Partner paths were significant for child zBMI predicting parent BMI at 4 and 12 months. Maintenance condition moderated actor/partner paths in the model.
CONCLUSIONS
Child weight change may motivate parents to make environmental and behavioural changes that impact their own weight.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00759746.",2021,Partner paths were significant for child zBMI predicting parent BMI at 4 and 12 months.,"['Parent-child dyads (n = 172) with overweight/obesity (child mean zBMI = 2.16\u2009±\u20090.39', 'parent-child dyads enrolled in family-based treatment (FBT']","['maintenance interventions (Social Facilitation Maintenance [SFM]-high dose, SFM-low dose or control']","['weight loss and maintenance', 'Weight/height', 'weight changes', 'child zBMI predicting parent BMI']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4552097', 'cui_str': 'Epidermal nevus syndrome'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",172.0,0.0215294,Partner paths were significant for child zBMI predicting parent BMI at 4 and 12 months.,"[{'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Fowler', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Anne Claire', 'Initials': 'AC', 'LastName': 'Grammer', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Mary Katherine', 'Initials': 'MK', 'LastName': 'Ray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Balantekin', 'Affiliation': 'Department of Exercise and Nutrition Sciences, University of Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Stein', 'Affiliation': 'Department of Internal Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Rachel P', 'Initials': 'RP', 'LastName': 'Kolko Conlon', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R Robinson', 'Initials': 'RR', 'LastName': 'Welch', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical & Health Psychology, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Pediatric obesity,['10.1111/ijpo.12697']
1723,32723696,"A 5-year multicentre randomized controlled trial comparing personalized, frozen and fresh blastocyst transfer in IVF.","RESEARCH QUESTION
Does clinical performance of personalized embryo transfer (PET) guided by endometrial receptivity analysis (ERA) differ from frozen embryo transfer (FET) or fresh embryo transfer in infertile patients undergoing IVF?
DESIGN
Multicentre, open-label randomized controlled trial; 458 patients aged 37 years or younger undergoing IVF with blastocyst transfer at first appointment were randomized to PET guided by ERA, FET or fresh embryo transfer in 16 reproductive clinics.
RESULTS
Clinical outcomes by intention-to-treat analysis were comparable, but cumulative pregnancy rate was significantly higher in the PET (93.6%) compared with FET (79.7%) (P = 0.0005) and fresh embryo transfer groups (80.7%) (P = 0.0013). Analysis per protocol demonstrates that live birth rates at first embryo transfer were 56.2% in PET versus 42.4% in FET (P = 0.09), and 45.7% in fresh embryo transfer groups (P = 0.17). Cumulative live birth rates after 12 months were 71.2% in PET versus 55.4% in FET (P = 0.04), and 48.9% in fresh embryo transfer (P = 0.003). Pregnancy rates at the first embryo transfer in PET, FET and fresh embryo transfer arms were 72.5% versus 54.3% (P = 0.01) and 58.5% (P = 0.05), respectively. Implantation rates at first embryo transfer were 57.3% versus 43.2% (P = 0.03), and 38.6% (P = 0.004), respectively. Obstetrical outcomes, type of delivery and neonatal outcomes were similar in all groups.
CONCLUSIONS
Despite 50% of patients dropping out compared with 30% initially planned, per protocol analysis demonstrates statistically significant improvement in pregnancy, implantation and cumulative live birth rates in PET compared with FET and fresh embryo transfer arms, indicating the potential utility of PET guided by the ERA test at the first appointment.",2020,"Implantation rates at first embryo transfer were 57.3% versus 43.2% (P = 0.03), and 38.6% (P = 0.004), respectively.","['458 patients aged 37 years or younger undergoing IVF with blastocyst transfer at first appointment', 'in 16 reproductive clinics', 'infertile patients undergoing IVF']","['FET', 'PET guided by ERA, FET or fresh embryo transfer', 'personalized embryo transfer (PET) guided by endometrial receptivity analysis (ERA) differ from frozen embryo transfer (FET) or fresh embryo transfer', 'personalized, frozen and fresh blastocyst transfer']","['pregnancy, implantation and cumulative live birth rates', 'Implantation rates', 'live birth rates at first embryo transfer', 'Obstetrical outcomes, type of delivery and neonatal outcomes', 'Pregnancy rates', 'cumulative pregnancy rate', 'Cumulative live birth rates']","[{'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}]","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",458.0,0.196615,"Implantation rates at first embryo transfer were 57.3% versus 43.2% (P = 0.03), and 38.6% (P = 0.004), respectively.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Simón', 'Affiliation': 'Department of Pediatrics, Obstetrics and Gynecology, University of Valencia, Valencia 46010, Spain; Igenomix Foundation-INCLIVA, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain; IVI-RMA Valencia, Plaza de la Policía Local 3, Valencia 46015, Spain. Electronic address: carlos.simon@uv.es.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Igenomix SL, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Cabanillas', 'Affiliation': 'IVI-RMA Valencia, Plaza de la Policía Local 3, Valencia 46015, Spain.'}, {'ForeName': 'Iavor', 'Initials': 'I', 'LastName': 'Vladimirov', 'Affiliation': 'SBALAGRM-Sofia, 5 Baku St, Sofia 1756, Bulgaria.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Castillón', 'Affiliation': 'IVI-RMA Barcelona, Ronda General Mitre 14 Barcelona 08017, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Giles', 'Affiliation': 'IVI-RMA Valencia, Plaza de la Policía Local 3, Valencia 46015, Spain.'}, {'ForeName': 'Kubra', 'Initials': 'K', 'LastName': 'Boynukalin', 'Affiliation': 'Bahçeci Health Group-Fulya IVF Centre, Hakki Yeten Cad, 11 Kat 3, Terrace Fulya Istanbul 34365, Turkey.'}, {'ForeName': 'Necati', 'Initials': 'N', 'LastName': 'Findikli', 'Affiliation': 'Bahçeci Health Group-Fulya IVF Centre, Hakki Yeten Cad, 11 Kat 3, Terrace Fulya Istanbul 34365, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Bahçeci', 'Affiliation': 'Bahçeci Health Group-Fulya IVF Centre, Hakki Yeten Cad, 11 Kat 3, Terrace Fulya Istanbul 34365, Turkey.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Ortega', 'Affiliation': 'IVI-RMA Madrid, Av Del Talgo 68, Aravaca Madrid 28023, Spain.'}, {'ForeName': 'Carmina', 'Initials': 'C', 'LastName': 'Vidal', 'Affiliation': 'IVI-RMA Valencia, Plaza de la Policía Local 3, Valencia 46015, Spain.'}, {'ForeName': 'Miyako', 'Initials': 'M', 'LastName': 'Funabiki', 'Affiliation': 'Oak Clinic Japan, 2-7-9 Tamade-Nishi, Nishinari-ku Osaka 557-0045, Japan.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Izquierdo', 'Affiliation': 'ProcreaTec, Calle Manuel de Falla 6-8, Madrid 28036, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'ProcreaTec, Calle Manuel de Falla 6-8, Madrid 28036, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Portela', 'Affiliation': 'IVI-RMA Vigo, Plaza Francisco Fernández del Riego 7, Vigo 36203, Spain.'}, {'ForeName': 'Nilo', 'Initials': 'N', 'LastName': 'Frantz', 'Affiliation': 'Nilo Frantz Reproductive Medicine, Av Dr Nilo Peçanha 1221 - 10° andar, Boa Vista Porto Alegre, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Kulmann', 'Affiliation': 'Nilo Frantz Reproductive Medicine, Av Dr Nilo Peçanha 1221 - 10° andar, Boa Vista Porto Alegre, Brazil.'}, {'ForeName': 'Sagiri', 'Initials': 'S', 'LastName': 'Taguchi', 'Affiliation': 'Oak Clinic Japan, 2-7-9 Tamade-Nishi, Nishinari-ku Osaka 557-0045, Japan.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Labarta', 'Affiliation': 'IVI-RMA Valencia, Plaza de la Policía Local 3, Valencia 46015, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Colucci', 'Affiliation': 'Centro de Infertilidade e Medicina Fetal do Norte Fluminense, R Barão da Lagoa Dourada 409 - Centro, Campos dos Goytacazes Rio de Janeiro 28035-210, Brazil.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Mackens', 'Affiliation': 'Department of Reproductive Medicine, Universitair Ziekenhuis Brussel, 101 Laarbeeklaan, Jette Brussels 1090, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Santamaría', 'Affiliation': 'IVI-RMA Barcelona, Ronda General Mitre 14 Barcelona 08017, Spain.'}, {'ForeName': 'Elkin', 'Initials': 'E', 'LastName': 'Muñoz', 'Affiliation': 'IVI-RMA Vigo, Plaza Francisco Fernández del Riego 7, Vigo 36203, Spain.'}, {'ForeName': 'Saúl', 'Initials': 'S', 'LastName': 'Barrera', 'Affiliation': 'IVI-RMA Panama, Calle 50 & Calle 57 Este, Panama City Panamá 07185.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'García-Velasco', 'Affiliation': 'IVI-RMA Madrid, Av Del Talgo 68, Aravaca Madrid 28023, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández', 'Affiliation': 'IVI-RMA Sevilla, Av República Argentina 58 Sevilla 41011, Spain; Departamento de Cirugía, Universidad de Sevilla, Avda. Sánchez Pizjuan S/N Sevilla 41009, Spain; Departamento de Biología Molecular e Ingeniería Bioquímica, Universidad Pablo de Olavide Sevilla 41013, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ferrando', 'Affiliation': 'IVI-RMA Bilbao, Leioa Paseo Landabarri 1Vizcaya 48940, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ruiz', 'Affiliation': 'Igenomix SL, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Monash Medical Centre, 246 Clayton Road, Clayton Victoria 3168, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Valbuena', 'Affiliation': 'Igenomix Foundation-INCLIVA, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain; Igenomix SL, Parque Tecnológico de Paterna, Ronda Narciso Monturiol Estarriol 11B, Paterna Valencia 46980, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.06.002']
1724,32726530,Uterine-Artery Embolization or Myomectomy for Uterine Fibroids.,"BACKGROUND
Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.
METHODS
We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.
RESULTS
A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.
CONCLUSIONS
Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).",2020,"Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization.","['women who had symptomatic uterine fibroids and did not want to undergo hysterectomy', 'women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization', 'Uterine Fibroids', 'women with symptomatic uterine fibroids', '254 women, recruited at 29 hospitals in the United Kingdom']","['myomectomy', 'Uterine-Artery Embolization or Myomectomy', 'uterine-artery embolization', 'open abdominal, laparoscopic, or hysteroscopic myomectomy', 'myomectomy group (of whom 105 underwent myomectomy', 'uterine-artery embolization group (of whom 98 underwent embolization']","['mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire', 'Perioperative and postoperative complications', 'fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range', 'fibroid-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",254.0,0.316936,"Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization.","[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Manyonda', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Belli', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Mary-Ann', 'Initials': 'MA', 'LastName': 'Lumsden', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McKinnon', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wu', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Sirkeci', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Klim', 'Initials': 'K', 'LastName': 'McPherson', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1914735']
1725,32730985,"Randomized clinical trial: expanded autologous bone marrow mesenchymal cells combined with allogeneic bone tissue, compared with autologous iliac crest graft in lumbar fusion surgery.","BACKGROUND CONTEXT
Although autogenous iliac crest bone graft (AICBG) is considered the gold-standard graft material for spinal fusion, new bone substitutes are being developed to avoid associated complications and disadvantages. By combining autologous bone marrow mesenchymal stromal cells (MSCs) expanded ex vivo and allogenic cancellous bone graft, we obtain a tissue-engineered product that is osteoconductive and potentially more osteogenic and osteoinductive than AICBG, owing to the higher concentration of MSCs.
PURPOSE
This study aimed to evaluate the feasibility and safety of implanting a tissue-engineered product consisting of expanded bone marrow MSCs loaded onto allograft bone (MSC+allograft) for spinal fusion in degenerative spine disease, as well as to assess its clinical and radiological efficacy.
STUDY DESIGN/SETTING
A prospective, multicenter, open-label, blinded-reader, randomized, parallel, single-dose phase I-II clinical trial.
PATIENT SAMPLE
A total of 73 adult patients from 5 hospitals, with Meyerding grade I-II L4-L5 degenerative spondylolisthesis and/or with L4-L5 degenerative disc disease who underwent spinal fusion through transforaminal lumbar interbody fusion (TLIF).
OUTCOME MEASURES
Spinal fusion was assessed by plain X-ray at 3, 6, and 12 months and by computed tomography (CT) at 6 and 12 months post-treatment. An independent radiologist performed blinded assessments of all images. Clinical outcomes were measured as change from baseline value: visual analog scale for lumbar and sciatic pain at 12 days, 3, 6, and 12 months posttreatment, and Oswestry Disability Index and Short Form-36 at 3, 6, and 12 months posttreatment.
METHODS
Patients who underwent L4-L5 TLIF were randomized for posterior graft type only, and received either MSC+allograft (the tissue-engineered product, group A) or AICBG (standard graft material, group B). Standard graft material was used for anterior fusion in all patients. Feasibility was measured primarily as the percentage of randomized patients who underwent surgery in each treatment group. Safety was assessed by analyzing treatment-emergent adverse events (AEs) for the full experimental phase and appraising their relationship to the experimental treatment. Outcome measures, both radiological and clinical, were compared between the groups.
RESULTS
Seventy-three patients were randomized in this study, 36 from the MSC+allograft group and 37 from the AICBG group, and 65 were surgically treated (31 group A, 34 group B). Demographic and comorbidity data showed no difference between groups. Most patients were diagnosed with grade I or II degenerative spondylolisthesis. MSC+allograft was successfully implanted in 86.1% of randomized group A patients. Most patients suffered treatment-emergent AEs during the study (88.2% in group A and 97.1% in group B), none related to the experimental treatment. X-ray-based rates of posterior spinal fusion were significantly higher for the experimental group at 6 months (p=.012) and 12 months (p=.0003). CT-based posterior fusion rates were significantly higher for MSC+allograft at 6 months (92.3% vs 45.7%; p=.0001) and higher, but not significantly, at 12 months (76.5% vs 65.7%; p=.073). CT-based complete response (defined as the presence of both posterior intertransverse fusion and anterior interbody fusion) was significantly higher at 6 months for MSC+allograft than for AICBG (70.6% vs 40%; p=.0038), and remained so at 12 months (70.6% vs 51.4%; p=.023). Clinical results including patient-reported outcomes improved postsurgery, although there were no differences between groups.
CONCLUSIONS
Compared with the current gold standard, our experimental treatment achieved a higher rate of posterior spinal fusion and radiographic complete response to treatment at 6 and 12 months after surgery. The treatment clearly improved patient quality of life and decreased pain and disability at rates similar to those for the control arm. The safety profile of the tissue-engineered product was also similar to that for the standard material, and no AEs were linked to the product. Procedural AEs did not increase as a result of BM aspiration. The use of expanded bone marrow MSCs combined with cancellous allograft is a feasible and effective technique for spinal fusion, with no product-related AEs found in our study.",2020,"CT-based posterior fusion rates were significantly higher for MSC+allograft at 6 months (92.3% vs 45.7%; p=.0001) and higher, but not significantly, at 12 months (76.5% vs 65.7%; p=.073).","['73 adult patients from 5 hospitals, with Meyerding grade I-II L4-L5 degenerative spondylolisthesis and/or with L4-L5 degenerative disc disease who underwent spinal fusion through transforaminal lumbar interbody fusion (TLIF', 'Patients who underwent', 'Most patients were diagnosed with grade I or II degenerative spondylolisthesis', 'Seventy-three patients were randomized in this study, 36 from the MSC+allograft group and 37 from the AICBG group, and 65 were surgically treated (31 group A, 34 group B', 'lumbar fusion surgery']","['autologous bone marrow mesenchymal cells combined with allogeneic bone tissue', 'autogenous iliac crest bone graft (AICBG', 'autologous iliac crest graft', 'implanting a tissue-engineered product consisting of expanded bone marrow MSCs loaded onto allograft bone (MSC+allograft', 'autologous bone marrow mesenchymal stromal cells (MSCs', 'MSC+allograft', 'L4-L5', 'expanded bone marrow MSCs combined with cancellous allograft', 'MSC+allograft (the tissue-engineered product, group A) or AICBG']","['Safety', 'CT-based complete response', 'rate of posterior spinal fusion and radiographic complete response', 'patient quality of life and decreased pain and disability', 'Oswestry Disability Index (ODI) and Short Form-36 (SF-36', 'X-ray-based rates of posterior spinal fusion', 'CT-based posterior fusion rates', 'change from baseline value: visual analog scale (VAS) for lumbar and sciatic pain', 'feasibility and safety', 'BM aspiration', 'Feasibility']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0264184', 'cui_str': 'Degenerative spondylolisthesis'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0391978', 'cui_str': 'Bone (tissue) structure'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0596171', 'cui_str': 'Tissue Engineering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]",73.0,0.125911,"CT-based posterior fusion rates were significantly higher for MSC+allograft at 6 months (92.3% vs 45.7%; p=.0001) and higher, but not significantly, at 12 months (76.5% vs 65.7%; p=.073).","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García de Frutos', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain; Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Univ Autonoma de Barcelona, Spain. Electronic address: agf.agfrutos@gmail.com.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'González-Tartière', 'Affiliation': ""Spine research unit, Vall d'Hebron Research Institute, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Coll Bonet', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Ubierna Garcés', 'Affiliation': 'Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Department of Orthopedic Surgery, Hospital Germas Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Del Arco Churruca', 'Affiliation': 'Department of Orthopedic Surgery, Hospital de Sant Pau, Barcelona, Spain; Unitat Funcional de Cirurgia de la Columna Vertebral, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rivas García', 'Affiliation': ""Department of Radiodiagnosis, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Matamalas Adrover', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Saló Bru', 'Affiliation': 'Univ Autonoma de Barcelona, Spain; Unitat Funcional de Cirurgia de la Columna Vertebral, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Orthopedic Surgery, Hospital de Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Vila-Canet', 'Affiliation': 'Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Department of Orthopedic Surgery, Hospital de Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'García-Lopez', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Vives', 'Affiliation': ""Univ Autonoma de Barcelona, Spain; Banc de Sang i Teixits de Catalunya, Barcelona, Spain; Musculoskeletal Tissue Engineering Group, Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Codinach', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bagó Granell', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Càceres Palou', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain; Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Univ Autonoma de Barcelona, Spain.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.07.014']
1726,32742642,A period of 10 weeks of increased protein consumption does not alter faecal microbiota or volatile metabolites in healthy older men: a randomised controlled trial.,"Diet has a major influence on the composition and metabolic output of the gut microbiome. Higher-protein diets are often recommended for older consumers; however, the effect of high-protein diets on the gut microbiota and faecal volatile organic compounds (VOC) of elderly participants is unknown. The purpose of the study was to establish if the faecal microbiota composition and VOC in older men are different after a diet containing the recommended dietary intake (RDA) of protein compared with a diet containing twice the RDA (2RDA). Healthy males (74⋅2 (sd 3⋅6) years; n 28) were randomised to consume the RDA of protein (0⋅8 g protein/kg body weight per d) or 2RDA, for 10 weeks. Dietary protein was provided via whole foods rather than supplementation or fortification. The diets were matched for dietary fibre from fruit and vegetables. Faecal samples were collected pre- and post-intervention for microbiota profiling by 16S ribosomal RNA amplicon sequencing and VOC analysis by head space/solid-phase microextraction/GC-MS. After correcting for multiple comparisons, no significant differences in the abundance of faecal microbiota or VOC associated with protein fermentation were evident between the RDA and 2RDA diets. Therefore, in the present study, a twofold difference in dietary protein intake did not alter gut microbiota or VOC indicative of altered protein fermentation.",2020,"After correcting for multiple comparisons, no significant differences in the abundance of faecal microbiota or VOC associated with protein fermentation were evident between the RDA and 2RDA diets.","['Healthy males (74⋅2 (sd 3⋅6) years; n 28', 'older men', 'healthy older men']",[],"['faecal microbiota composition and VOC', 'faecal microbiota or volatile metabolites', 'gut microbiota or VOC indicative of altered protein fermentation', 'abundance of faecal microbiota or VOC associated with protein fermentation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2350439', 'cui_str': 'Volatile Organic Compounds'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",28.0,0.0232378,"After correcting for multiple comparisons, no significant differences in the abundance of faecal microbiota or VOC associated with protein fermentation were evident between the RDA and 2RDA diets.","[{'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Mitchell', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'McKenzie', 'Affiliation': 'Department of Physiology, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Mitchell', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Zeng', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'R F', 'Initials': 'RF', 'LastName': ""D'Souza"", 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ramzan', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rettedal', 'Affiliation': 'Food Nutrition & Health Team, AgResearch, Palmerston North, New Zealand.'}, {'ForeName': 'S O', 'Initials': 'SO', 'LastName': 'Knowles', 'Affiliation': 'Food Nutrition & Health Team, AgResearch, Palmerston North, New Zealand.'}, {'ForeName': 'N C', 'Initials': 'NC', 'LastName': 'Roy', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sjödin', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'K-H', 'Initials': 'KH', 'LastName': 'Wagner', 'Affiliation': 'Department of Nutritional Sciences and Research Platform Active Ageing, University of Vienna, Vienna, Austria.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}]",Journal of nutritional science,['10.1017/jns.2020.15']
1727,32742646,Attenuation of glycaemic and insulin responses following tapioca resistant maltodextrin consumption in healthy subjects: a randomised cross-over controlled trial.,"Resistant maltodextrin (RMD) from various sources of starch has been extensively studied. However, studies which reported the effects of tapioca RMD (TRM) on glucose and insulin response are lacking. This study investigated the effect of TRM on postprandial plasma glucose and serum insulin in healthy subjects. Additionally, satiety and gastrointestinal tolerability were also evaluated. Sixteen healthy participants received five different treatments on five separate days. Participants received 50 g of either: glucose (GL), tapioca maltodextrin (TM), TRM, MIX15% (7⋅5 g TRM + 42⋅5 g TM) or MIX50% (25 g TRM + 25 g TM). Plasma glucose, serum insulin and subjective appetite responses were measured postprandially over 180 min. Gastrointestinal symptoms were evaluated by questionnaire before and after each test day. Results showed that at 30 min after treatment drinks, plasma glucose after TRM was significantly lowest (104⋅60 (sem 2⋅63 mg/dl) than after GL (135⋅87 (sem 4⋅88) mg/dl; P <0⋅001), TM (127⋅93 (sem 4⋅05) mg/dl; P = 0⋅001), MIX15% (124⋅67 (sem 5⋅73) mg/dl; P = 0⋅039) and MIX50% (129⋅33 (sem 5⋅23) mg/dl; P = 0⋅003) (1 mg/dl = 0⋅0555 mmol/l). In addition, TRM also significantly reduced serum insulin (13⋅01 (sem 2⋅12) μIU/ml) compared with GL (47⋅90 (sem 11⋅93) μIU/ml; P = 0⋅013), TM (52⋅96 (sem 17⋅68) μIU/ml; P = 0⋅002) and MIX50% (33⋅16 (sem 4⋅99) μIU/ml; P = 0⋅008). However, there were no significant differences in subjective appetite between treatments ( P > 0⋅05). A single high dose of TRM (50 g) caused flatulence ( P < 0⋅05). Tapioca resistant maltodextrin has low digestibility in the small intestine and, therefore, reduced incremental plasma glucose and serum insulin, without affecting satiety in healthy subjects over 180 min. Gastrointestinal tolerability of TRM should be considered when consumed in high doses.",2020,A single high dose of TRM (50 g) caused flatulence ( P < 0⋅05).,"['healthy subjects over 180 min', 'Sixteen healthy participants', 'healthy subjects']","['μIU', 'Tapioca resistant maltodextrin', 'tapioca RMD (TRM', 'tapioca resistant maltodextrin consumption', 'TRM', 'glucose (GL), tapioca maltodextrin (TM), TRM, MIX15% (7⋅5 g TRM + 42⋅5 g TM) or MIX50', 'Resistant maltodextrin (RMD']","['Plasma glucose, serum insulin and subjective appetite responses', 'serum insulin', 'postprandial plasma glucose and serum insulin', 'satiety and gastrointestinal tolerability', 'plasma glucose after TRM', 'Gastrointestinal tolerability', 'subjective appetite', 'flatulence', 'Gastrointestinal symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0007335', 'cui_str': 'Manihot esculenta'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C1853698', 'cui_str': 'Rippling muscle disease'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]",16.0,0.0769949,A single high dose of TRM (50 g) caused flatulence ( P < 0⋅05).,"[{'ForeName': 'Junaida', 'Initials': 'J', 'LastName': 'Astina', 'Affiliation': 'Food and Nutrition Program, Department of Nutrition and Dietetics, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Suwimol', 'Initials': 'S', 'LastName': 'Sapwarobol', 'Affiliation': 'Department of Nutrition and Dietetics, Chulalongkorn University, Bangkok, Thailand.'}]",Journal of nutritional science,['10.1017/jns.2020.22']
1728,32739460,The effect of moderate-intensity aerobic training on pulmonary function and estrogen receptor-alpha gene in postmenopausal women with vitamin D deficiency: A randomized control trial.,"BACKGROUND
The impact of aerobic training on pulmonary function by modulating gene expression of estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D) in postmenopausal women (PMW) with Vit D deficiency is uncertain.
OBJECTIVE
The purpose of this study was to examine the effect of 12 weeks of moderate-intensity aerobic training on pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D in PMW with Vit D deficiency.
METHODS
Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs) were randomized to exercise (EX, n = 15) and control (C, n = 14) groups. The EX group performed moderate-intensity aerobic training for 12 weeks (50-60 min/day, 3 days/week at 65-70% of maximal heart rate reserve), but the C group participated in no intervention and maintain their normal lifestyle during 12 weeks. The pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D were measured at baseline and week-12.
RESULTS
After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
CONCLUSIONS
The results suggested that 12 weeks of moderate-intensity aerobic training increased lymphocyte ERα gene expression as well as serum Vit D in sedentary PMW with Vit D deficiency although pulmonary function was not improved.",2020,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","['postmenopausal women with vitamin D deficiency', 'postmenopausal women (PMW) with Vit D deficiency', 'Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs']","['aerobic exercise intervention', 'aerobic training', 'C group participated in no intervention and maintain their normal lifestyle', 'exercise (EX', 'moderate-intensity aerobic training']","['pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D', 'estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D', 'pulmonary function parameters and sex hormones (17β-estradiol and progesterone', 'lymphocyte ERα gene expression', 'serum Vit D', 'pulmonary function and estrogen receptor-alpha gene', 'pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptors alpha'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",29.0,0.0296952,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran. Electronic address: ba.tartibian@gmail.com.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: rahmati_bio@yahoo.com.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: r.afsargarebag@gmail.com.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: Z.sheikhlou@gmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103510']
1729,32739862,Benefits of social cognitive skills training within routine community mental health services: Evidence from a non-randomized parallel controlled study.,"Although social cognitive impairments are evident in patients with schizophrenia across many cultures, psychosocial interventions are less used in Eastern countries. Despite a growing emphasis on community care in mental health services in Eastern countries, the synergistic effects of social cognitive intervention strategies on routine community mental health services are not well documented. This study aimed to adapt a group-based social cognitive skills training (SCST) program for use in a Korean context and evaluate its feasibility and preliminary effects among community-dwelling individuals with schizophrenia. Forty-seven patients were assigned to either the SCST + treatment as usual (TAU) group (n = 21) or the TAU only group (n = 24). Participants completed tasks to assess social cognition, social functioning, neurocognition, and psychiatric symptoms before and after treatment. Over a period of approximately 12 weeks, drop-out rates were comparably low in both groups, and the attendance rates for the SCST program were high (85.7 %, mean sessions attended = 20.56/24 sessions). The SCST + TAU group demonstrated significant improvements in facial affect recognition, social functioning, and psychiatric symptoms compared to the TAU only group. A non-significant trend in theory of mind was observed, along with no improvements in social perception and neurocognition. The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.",2020,The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.,"['mental health services in Eastern countries', 'community-dwelling individuals with schizophrenia', 'Korean outpatients with schizophrenia', 'Forty-seven patients', 'routine community mental health services', 'patients with schizophrenia']","['TAU', 'social cognitive skills training', 'social cognitive skills training (SCST) program', 'SCST + TAU', 'SCST program', 'SCST + treatment as usual (TAU']","['social cognition, social functioning, neurocognition, and psychiatric symptoms', 'facial affect recognition, social functioning, and psychiatric symptoms', 'attendance rates', 'social perception and neurocognition']","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0579088', 'cui_str': 'Cognitive skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0037427', 'cui_str': 'Perception, Social'}]",47.0,0.0204504,The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.,"[{'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Ye-Jin', 'Initials': 'YJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Yun', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Kiho', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea; Korea University Mind Health Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Wonhye', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Psychology, National Center for Mental Health, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Inje University Ilsan-Paik Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'P Horan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Kee-Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea; Korea University Mind Health Institute, Seoul, Republic of Korea; Department of Psychology, Wesleyan University, Middletown, USA. Electronic address: kchoi1@korea.ac.kr.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102314']
1730,32770186,"How to Teach Medical Students About Pain and Dementia: E-Learning, Experiential Learning, or Both?","OBJECTIVE
Pain management in persons with mild to moderate dementia poses unique challenges because of altered pain modulation and the tendency of some individuals to perseverate. We aimed to test the impact of an e-learning module about pain in communicative people with dementia on third-year medical students who had or had not completed an experiential geriatrics course.
DESIGN
Analysis of pre- to postlearning changes and comparison of the same across the student group.
SETTING
University of Pittsburgh School of Medicine and Saint Louis University School of Medicine.
SUBJECTS
One hundred four University of Pittsburgh and 57 Saint Louis University medical students.
METHODS
University of Pittsburgh students were randomized to view either the pain and dementia module or a control module on pain during a five-day geriatrics course. Saint Louis University students were asked to complete either of the two modules without the context of a geriatrics course. A 10-item multiple choice knowledge test and three-item attitudes and confidence questionnaires were administered before viewing the module and up to seven days later.
RESULTS
Knowledge increase was significantly greater among students who viewed the dementia module while participating in the geriatrics course than among students who viewed the module without engaging in the course (P < 0.001). The modules did not improve attitudes in any group, while student confidence improved in all groups.
CONCLUSIONS
Medical students exposed to e-learning or experiential learning demonstrated improved confidence in evaluating and managing pain in patients with dementia. Those exposed to both educational methods also significantly improved their knowledge.",2020,"The modules did not improve attitudes in any group, while student confidence improved in all groups.
","['University of Pittsburgh students', 'Saint Louis University students', 'patients with dementia', 'communicative people with dementia on third-year medical students who had or had not completed an experiential geriatrics course', 'One hundred four University of Pittsburgh and 57 Saint Louis University medical students', 'Teach Medical Students About Pain and Dementia', 'University of Pittsburgh School of Medicine and Saint Louis University School of Medicine', 'persons with mild to moderate dementia']","['e-learning module about pain', 'pain and dementia module or a control module']","['student confidence', 'confidence in evaluating and managing pain']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0014048', 'cui_str': 'St. Louis encephalitis virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C1444661', 'cui_str': 'Stopped before completion'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.0317668,"The modules did not improve attitudes in any group, while student confidence improved in all groups.
","[{'ForeName': 'Keelin', 'Initials': 'K', 'LastName': 'Moehl', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rollin M', 'Initials': 'RM', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine (Geriatric Medicine), University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shega', 'Affiliation': 'VITAS Healthcare and University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Malec', 'Affiliation': 'Department of Medicine (Geriatric and Palliative Medicine), University of Chicago, Chicago, Illinois.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kelley Fitzgerald', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Science, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Robbins-Welty', 'Affiliation': 'Duke University Hospital, Durham, North Carolina.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Zoberi', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tait', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'VITAS Healthcare and University of Central Florida, Orlando, Florida.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Deverts', 'Affiliation': 'Office of Research, University of Pittsburgh School of Dental Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Zsuzsa', 'Initials': 'Z', 'LastName': 'Horvath', 'Affiliation': 'Department of Dental Public Health, University of Pittsburgh School of Dental Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Department of Medicine (Geriatric Medicine), University of Pittsburgh, Pittsburgh, Pennsylvania.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa187']
1731,32771996,Influence of Valve Type and Antiplatelet Regimen on Platelet Reactivity After TAVI: Subanalysis of the REAC-TAVI Trial.,"OBJECTIVES
Ticagrelor has proven more effective than clopidogrel at attaining a maintained suppression of high platelet reactivity (HPR) in aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI). This study aims to assess the influence of implanted valve type on the degree of platelet reactivity (PR) after TAVI.
METHODS
This study is a prespecified analysis of REAC-TAVI, a prospective, multicenter study that included patients on dual-antiplatelet therapy with aspirin and clopidogrel before TAVI. Patients with HPR (n = 48) were randomized to aspirin and clopidogrel or aspirin and ticagrelor for 3 months, while those without HPR (n = 20) were continued on aspirin and clopidogrel. PR was measured 6 hours, 24 hours, 5 days, 30 days, and 90 days after TAVI with VerifyNow assay. Bioprosthetic valves were classified as balloon-expandable valve (BEV), self-expandable valve (SEV), or other.
RESULTS
Sixty-eight patients comprising 32 BEVs, 28 SEVs, and 8 other valves were included. Devices were larger and postdilation was more frequent in the SEV group. Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001). PR after TAVI was similar in the three groups. Major cardiovascular adverse events, stroke, and hemorrhagic complications were comparable across the different bioprosthesis groups at 4-month follow-up.
CONCLUSIONS
The effect of valve type on PR after TAVI is similar across the spectrum of most transcatheter valves. In our sample, ticagrelor achieved a faster and more effective reduction in PR than clopidogrel in patients with HPR undergoing TAVI, irrespective of valve type.",2020,"Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001).","['included patients on dual-antiplatelet therapy with aspirin and clopidogrel before TAVI', 'patients with HPR undergoing TAVI, irrespective of valve type', 'Sixty-eight patients comprising 32 BEVs, 28 SEVs, and 8 other valves were included', 'Patients with HPR (n = 48', 'aortic stenosis patients undergoing transcatheter aortic valve implantation (TAVI']","['Ticagrelor', 'aspirin and clopidogrel or aspirin and ticagrelor', 'aspirin and clopidogrel', 'TAVI', 'clopidogrel', 'ticagrelor']","['platelet reactivity (PR', 'Platelet Reactivity', 'Major cardiovascular adverse events, stroke, and hemorrhagic complications']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",48.0,0.0342596,"Follow-up PR was lower in patients treated with ticagrelor vs those treated with clopidogrel at all time points after TAVI, including patients without baseline HPR (P<.001).","[{'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Trejo-Velasco', 'Affiliation': ''}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-González', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Tello-Montoliu', 'Affiliation': ''}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Baz-Alonso', 'Affiliation': ''}, {'ForeName': 'Pablo Juan', 'Initials': 'PJ', 'LastName': 'Salvadores', 'Affiliation': ''}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Molina-Navarro', 'Affiliation': ''}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Paredes-Galán', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'De-Miguel-Castro', 'Affiliation': ''}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bastos-Fernandez', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz-Saez', 'Affiliation': ''}, {'ForeName': 'Saleta', 'Initials': 'S', 'LastName': 'Fernández-Barbeira', 'Affiliation': ''}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Iñiguez-Romo', 'Affiliation': ''}, {'ForeName': 'Victor Alfonso', 'Initials': 'VA', 'LastName': 'Jimenez-Diaz', 'Affiliation': 'Cardiovascular Research Unit & Cardiology Department, Hospital Álvaro Cunqueiro, University Hospital of Vigo, Estrada de Clara Campoamor, 341, 36312, Vigo, Spain. sooner_79@hotmail.com or victor.alfonso.jimenez.diaz@sergas.es.'}]",The Journal of invasive cardiology,[]
1732,32779728,Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan.,"INTRODUCTION
Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists.
METHODS
The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving ≥10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals.
DISCUSSION
The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.",2020,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","['patients with COVID-19 and severe hypoxia', '1000 adult patients with COVID-19 receiving ≥10\xa0L/min of oxygen or on']","['Low-dose hydrocortisone', 'mechanical ventilation to intravenous hydrocortisone 200\xa0mg daily vs placebo (0.9% saline', 'Corticosteroids']","['longer time to viral clearance', 'Kryger Jensen and Lange test in the intention to treat population', 'health-related quality of life', 'days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy', 'time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality', 'serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C3665438', 'cui_str': 'Juxtapapillary focal retinitis AND retinochoroiditis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0521300', 'cui_str': 'Life support procedure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",1000.0,0.37202,"Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations.","[{'ForeName': 'Marie Warrer', 'Initials': 'MW', 'LastName': 'Petersen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Tine Sylvest', 'Initials': 'TS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Helleberg', 'Affiliation': 'Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Maj-Brit Nørregaard', 'Initials': 'MN', 'LastName': 'Kjaer', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Granholm', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Carl Johan Steensen', 'Initials': 'CJS', 'LastName': 'Hjortsø', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Thomas Steen', 'Initials': 'TS', 'LastName': 'Jensen', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Morten Hylander', 'Initials': 'MH', 'LastName': 'Møller', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Peter Buhl', 'Initials': 'PB', 'LastName': 'Hjortrup', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mik', 'Initials': 'M', 'LastName': 'Wetterslev', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gitte Kingo', 'Initials': 'GK', 'LastName': 'Vesterlund', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Russell', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Vibeke Lind', 'Initials': 'VL', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Thoracic Anaesthesiology, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Tjelle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Andreasen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mohr', 'Affiliation': 'Department of Intensive Care, Gentofte Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Morten H', 'Initials': 'MH', 'LastName': 'Bestle', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Nordsjaellands Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lone Musaeus', 'Initials': 'LM', 'LastName': 'Poulsen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Mette Friberg', 'Initials': 'MF', 'LastName': 'Hitz', 'Affiliation': 'Internal Medicine Department, Endocrinology, Zealand University Hospital, Køge, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Lene Surland', 'Initials': 'LS', 'LastName': 'Knudsen', 'Affiliation': 'Department of Infectious Diseases, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Møller', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Naestved-Slagelse-Ringsted Hospital, Slagelse, Denmark.'}, {'ForeName': 'Christoffer Grant', 'Initials': 'CG', 'LastName': 'Sølling', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Viborg Hospital, Viborg, Denmark.'}, {'ForeName': 'Anne Craveiro', 'Initials': 'AC', 'LastName': 'Brøchner', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Kolding Hospital, Kolding, Denmark.'}, {'ForeName': 'Bodil Steen', 'Initials': 'BS', 'LastName': 'Rasmussen', 'Affiliation': 'Collaboration for Research in Intensive Care (CRIC), Copenhagen, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Nielsen', 'Affiliation': 'Department of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cronhjort', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rebecka Rubenson', 'Initials': 'RR', 'LastName': 'Wahlin', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Jakob', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cioccari', 'Affiliation': 'Department of Intensive Care Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Balasubramanian', 'Initials': 'B', 'LastName': 'Venkatesh', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Hammond', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Vivekanand', 'Initials': 'V', 'LastName': 'Jha', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, New Delhi, India.'}, {'ForeName': 'Sheila Nainan', 'Initials': 'SN', 'LastName': 'Myatra', 'Affiliation': 'Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Perner', 'Affiliation': 'Department of Intensive Care, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13673']
1733,32776237,Type 2 diabetes remission: 2 year within-trial and lifetime-horizon cost-effectiveness of the Diabetes Remission Clinical Trial (DiRECT)/Counterweight-Plus weight management programme.,"AIMS/HYPOTHESIS
Approximately 10% of total healthcare budgets worldwide are spent on treating diabetes and its complications, and budgets are increasing globally because of ageing populations and more expensive second-line medications. The aims of the study were to estimate the within-trial and lifetime cost-effectiveness of the weight management programme, which achieved 46% remissions of type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT).
METHODS
Within-trial analysis assessed costs of the Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet), along with glucose-lowering and antihypertensive medications, and all routine healthcare contacts. Lifetime cost per quality-adjusted life-year (QALY) was estimated according to projected durations of remissions, assuming continued relapse rates as seen in year 2 of DiRECT and consequent life expectancy, quality of life and healthcare costs.
RESULTS
Mean total 2 year healthcare costs for the intervention and control groups were £3036 and £2420, respectively: an incremental cost of £616 (95% CI -£45, £1269). Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314). Net remission at 2 years was 32.3% (95% CI 23.5%, 40.3%), and cost per remission achieved was £1907 (lower 95% CI: intervention dominates; upper 95% CI: £4212). Over a lifetime horizon, the intervention was modelled to achieve a mean 0.06 (95% CI 0.04, 0.09) QALY gain for the DiRECT population and mean total lifetime cost savings per participant of £1337 (95% CI £674, £2081), with the intervention becoming cost-saving within 6 years.
CONCLUSIONS/INTERPRETATION
Incorporating the lifetime healthcare cost savings due to periods of remission from diabetes and its complications, the DiRECT intervention is predicted to be both more effective (QALY gain) and cost-saving in adults with type 2 diabetes compared with standard care. This conclusion appears robust to various less favourable model scenarios, providing strong evidence that resources could be shifted cost-effectively to support achieving remissions with the DiRECT intervention.
TRIAL REGISTRATION
ISRCTN03267836 Graphical abstract.",2020,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","['type 2 diabetes at year 1 and 36% at year 2 in the Diabetes Remission Clinical Trial (DiRECT', 'adults with type 2 diabetes']","['DiRECT)/Counterweight-Plus weight management programme', 'Counterweight-Plus intervention in DiRECT (including training, programme materials, practitioner appointments and low-energy diet', 'weight management programme']","['life expectancy, quality of life and healthcare costs', 'healthcare costs', 'mean total lifetime cost savings', 'Mean total 2\xa0year healthcare costs', 'Net remission', 'cost per remission', 'Lifetime cost per quality-adjusted life-year (QALY', 'reduced oral glucose-lowering medications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}]","[{'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0931155,"Intervention costs (£1411; 95% CI £1308, £1511) were partially offset by lower other healthcare costs (£796; 95% CI £150, £1465), including reduced oral glucose-lowering medications by £231 (95% CI £148, £314).","[{'ForeName': 'Yiqiao', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Davies', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCombie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'C Martina', 'Initials': 'CM', 'LastName': 'Messow', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Grieve', 'Affiliation': 'Health Economics and Health Technology Assessment, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Wilma S', 'Initials': 'WS', 'LastName': 'Leslie', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Newcastle Magnetic Resonance Centre, Translational and Clinical Research Institute, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Michael E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, Dentistry and Nursing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Level 2, New Lister Building, Glasgow Royal Infirmary, 8-16 Alexandra Parade, Glasgow, G31 2ER, UK. mike.lean@glasgow.ac.uk.'}]",Diabetologia,['10.1007/s00125-020-05224-2']
1734,31518627,The mediating role of perceived crime in gender and built environment associations with park use and park-based physical activity among park users in high poverty neighborhoods.,"Women use parks less for physical activity than men, and explanations include gendered concerns regarding personal safety and access to walking paths. This study conducted mediation analyses to examine the effects of gender and presence of park walking path on park use, participation in park programs, and park-based physical activity through the hypothesized mediator (perception of crime). The sample included 3213 park users from 48 parks in high poverty neighborhoods in Los Angeles surveyed between 2013 and 2015; park-level factors were assessed through systematic observations of study parks. Women reported fewer park visits than men in the last 7 days (β = -0.17, p = 0.02) and had significantly higher perceived crime (β = 0.12, p < 0.0001) and perceived crime partially mediated the gender association with park visits (β gender, direct = -0.09, p = 0.19; β gender, indirect = -0.07, p < 0.0001). Similarly, the existence of a walking path in the park was significantly related to increased park use (β = 0.27, p = 0.006) and a lower level of perceived crime (β = -0.25, p = 0.0034) and perceived crime partially mediated the association of walking path with park visits (β walking path, direct = 0.18, p = 0.10; β walking path, indirect = 0.15, p = 0.005). The associations between gender, walking path, and park-based exercise and program participation were not meaningfully mediated by perceived crime. Among park users in majority Latino, high poverty neighborhoods, addressing crime concerns are likely necessary to increase park use among women and adults whose parks do not have a walking path. For park-based exercise and participation in park programs, gendered preferences regarding park-based physical activity should be explored.",2019,"Women reported fewer park visits than men in the last 7 days (β = -0.17, p = 0.02) and had significantly higher perceived crime (β = 0.12, p < 0.0001) and perceived crime partially mediated the gender association with park visits (β gender, direct = -0.09, p = 0.19; β gender, indirect = -0.07, p < 0.0001).","['3213 park users from 48 parks in high poverty neighborhoods in Los Angeles surveyed between 2013 and 2015; park-level factors were assessed through systematic observations of study parks', 'park users in majority Latino, high poverty neighborhoods', 'park users in high poverty neighborhoods']",['park walking path'],"['park visits', 'walking path with park visits (β walking path']","[{'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}]","[{'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",3213.0,0.0261094,"Women reported fewer park visits than men in the last 7 days (β = -0.17, p = 0.02) and had significantly higher perceived crime (β = 0.12, p < 0.0001) and perceived crime partially mediated the gender association with park visits (β gender, direct = -0.09, p = 0.19; β gender, indirect = -0.07, p < 0.0001).","[{'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Derose', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90401, United States of America. Electronic address: derose@rand.org.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90401, United States of America. Electronic address: bhan@rand.org.'}, {'ForeName': 'Sujeong', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90401, United States of America. Electronic address: sujeongp@rand.org.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Williamson', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90401, United States of America. Electronic address: swilliam@rand.org.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Cohen', 'Affiliation': 'RAND Corporation, 1776 Main Street, Santa Monica, CA 90401, United States of America. Electronic address: dcohen@rand.org.'}]",Preventive medicine,['10.1016/j.ypmed.2019.105846']
1735,33230503,COVID-19 pneumonia accurately detected on chest radiographs with artificial intelligence.,"Purpose
To investigate the diagnostic performance of an Artificial Intelligence (AI) system for detection of COVID-19 in chest radiographs (CXR), and compare results to those of physicians working alone, or with AI support.
Materials and methods
An AI system was fine-tuned to discriminate confirmed COVID-19 pneumonia, from other viral and bacterial pneumonia and non-pneumonia patients and used to review 302 CXR images from adult patients retrospectively sourced from nine different databases. Fifty-four physicians blind to diagnosis, were invited to interpret images under identical conditions in a test set, and randomly assigned either to receive or not receive support from the AI system. Comparisons were then made between diagnostic performance of physicians working with and without AI support. AI system performance was evaluated using the area under the receiver operating characteristic (AUROC), and sensitivity and specificity of physician performance compared to that of the AI system.
Results
Discrimination by the AI system of COVID-19 pneumonia showed an AUROC curve of 0.96 in the validation and 0.83 in the external test set, respectively. The AI system outperformed physicians in the AUROC overall (70% increase in sensitivity and 1% increase in specificity, p < 0.0001). When working with AI support, physicians increased their diagnostic sensitivity from 47% to 61% (p < 0.001), although specificity decreased from 79% to 75% (p = 0.007).
Conclusions
Our results suggest interpreting chest radiographs (CXR) supported by AI, increases physician diagnostic sensitivity for COVID-19 detection. This approach involving a human-machine partnership may help expedite triaging efforts and improve resource allocation in the current crisis.",2020,"When working with AI support, physicians increased their diagnostic sensitivity from 47% to 61% (p<0.001), although specificity decreased from 79% to 75% (p=0.007).
",[],['Artificial Intelligence (AI) system'],"['area under the receiver operating characteristic (AUROC), and sensitivity and specificity of physician performance', 'diagnostic sensitivity', 'specificity', 'physician diagnostic sensitivity']",[],"[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0371854,"When working with AI support, physicians increased their diagnostic sensitivity from 47% to 61% (p<0.001), although specificity decreased from 79% to 75% (p=0.007).
","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Dorr', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Chaves', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': 'María Mercedes', 'Initials': 'MM', 'LastName': 'Serra', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': 'Martín Elías', 'Initials': 'ME', 'LastName': 'Costa', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Seia', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cejas', 'Affiliation': 'Department of Diagnostic Imaging, Fleni, Buenos Aires, Argentina.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Department of Diagnostic Imaging, Clínica Indisa, Santiago, Chile.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Eyheremendy', 'Affiliation': 'Department of Diagnostic Imaging, Hospital Alemán, Buenos Aires, Argentina.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández Slezak', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': 'Mauricio F', 'Initials': 'MF', 'LastName': 'Farez', 'Affiliation': 'Entelai, Buenos Aires, Argentina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intelligence-based medicine,['10.1016/j.ibmed.2020.100014']
1736,32740079,The Bowel CLEANsing National Initiative: A Low-Volume Same-Day Polyethylene Glycol (PEG) Preparation vs Low-Volume Split-Dose PEG With Bisacodyl or High-Volume Split-Dose PEG Preparations-A Randomized Controlled Trial.,"INTRODUCTION
Bowel cleanliness has been shown to be superior with split-dose vs nonsplit preparations; we aimed to directly assess the poorly characterized comparative efficacies of split-dose vs same-day polyethylene glycol (PEG) regimens.
METHODS
In this study, one of a series of randomized trials performed across 10 Canadian endoscopy units, patients undergoing colonoscopies between 10:30 and 16:30 were allocated to PEG low-volume same-day (15 mg bisacodyl the day before, 2 L the morning of the procedure), low-volume split-dose (15 mg bisacodyl the day before, 1 L + 1 L), or high-volume split-dose (2 L + 2 L). Coprimary endpoints were adequate bowel cleansing based on the Boston Bowel Preparation Scale using in turn different threshold cutoffs.
RESULTS
Overall, 1,750 subjects were randomized equally across the 3 groups, with no differences in adequate bowel cleanliness rates (low-volume same-day, 90.5%; high-volume split-dose, 92.2%; P = 0.34; and low-volume split-dose, 87.9%; P = 0.17) for the Boston Bowel Preparation Scale ≥6 and 2 for each segment. Willingness to repeat the preparation was not significantly different between low-volume same-day (91.0%) and low-volume split-dose (92.5%; P = 0.40) but was greater than the high-volume split-dose (68.9%; P < 0.01). No significant differences were noted for withdrawal time, cecal intubation, or polyp detection rates.
DISCUSSION
In this large randomized trial of PEG regimens, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose.",2020,"Overall, 1,750 subjects were randomized equally across the 3 groups, with no differences in adequate bowel cleanliness rates (low-volume same-day, 90.5%; high-volume split-dose, 92.2%; P = 0.34; and low-volume split-dose, 87.9%; P = 0.17) for the Boston Bowel Preparation Scale ≥6 and 2 for each segment.","['10 Canadian endoscopy units, patients undergoing colonoscopies between 10:30 and 16:30 were allocated to', '1,750 subjects']","['Low-Volume Same-Day Polyethylene Glycol (PEG) Preparation vs Low-Volume Split-Dose PEG With Bisacodyl or High-Volume Split-Dose PEG Preparations', 'PEG low-volume same-day']","['adequate bowel cleansing based on the Boston Bowel Preparation Scale using in turn different threshold cutoffs', 'withdrawal time, cecal intubation, or polyp detection rates', 'adequate bowel cleanliness rates']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005632', 'cui_str': 'Bisacodyl'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0522513', 'cui_str': 'With cleanliness'}]",1750.0,0.0386822,"Overall, 1,750 subjects were randomized equally across the 3 groups, with no differences in adequate bowel cleanliness rates (low-volume same-day, 90.5%; high-volume split-dose, 92.2%; P = 0.34; and low-volume split-dose, 87.9%; P = 0.17) for the Boston Bowel Preparation Scale ≥6 and 2 for each segment.","[{'ForeName': 'Alan N', 'Initials': 'AN', 'LastName': 'Barkun', 'Affiliation': 'McGill University Health Center, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Martel', 'Affiliation': 'McGill University Health Center, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Ian L', 'Initials': 'IL', 'LastName': 'Epstein', 'Affiliation': 'Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Hallé', 'Affiliation': 'Hôpital du Saint-Sacrement, Québec, Québec, Canada.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hilsden', 'Affiliation': 'University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'James', 'Affiliation': 'University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Rostom', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sey', 'Affiliation': 'Western University, London, Ontario, Canada.'}, {'ForeName': 'Harminder', 'Initials': 'H', 'LastName': 'Singh', 'Affiliation': 'University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sultanian', 'Affiliation': 'Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Telford', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'von Renteln', 'Affiliation': 'Université de Montréal, Montreal, Quebec, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000760']
1737,32740086,Peripheral Corticotropin-Releasing Factor Triggers Jejunal Mast Cell Activation and Abdominal Pain in Patients With Diarrhea-Predominant Irritable Bowel Syndrome.,"INTRODUCTION
To determine the effect of peripheral CRF on intestinal barrier function in diarrhea-predominant IBS (IBS-D). Irritable bowel syndrome (IBS) pathophysiology has been linked to life stress, epithelial barrier dysfunction, and mast cell activation. Corticotropin-releasing factor (CRF) is a major mediator of stress responses in the gastrointestinal tract, yet its role on IBS mucosal function remains largely unknown.
METHODS
Intestinal response to sequential i.v. 5-mL saline solution (placebo) and CRF (100 μg) was evaluated in 21 IBS-D and 17 healthy subjects (HSs). A 20-cm jejunal segment was perfused with an isosmotic solution and effluents collected at baseline, 30 minutes after placebo, and 60 minutes after CRF. We measured water flux, albumin output, tryptase release, stress hormones, cardiovascular and psychological responses, and abdominal pain. A jejunal biopsy was obtained for CRF receptor expression assessment.
RESULTS
Water flux did not change after placebo in IBS-D and HS but significantly increased after CRF in IBS-D (P = 0.007). Basal luminal output of albumin was higher in IBS-D and increased further after CRF in IBS-D (P = 0.042). Basal jejunal tryptase release was higher in IBS-D, and CRF significantly increased it in both groups (P = 0.004), the response being higher in IBS-D than in HS (P = 0.0023). Abdominal pain worsened only in IBS-D after CRF and correlated with jejunal tryptase release, water flux, and albumin output. IBS-D displayed jejunal up-regulation of CRF2 and down-regulation of CRF1 compared with HS.
DISCUSSION
Stress via CRF-driven mast cell activation seems to be relevant in the pathophysiology of IBS-D.",2020,"RESULTS
Water flux did not change after placebo in IBS-D and HS but significantly increased after CRF in IBS-D (P = 0.007).","['Patients', '21 IBS-D and 17 healthy subjects (HSs', 'diarrhea-predominant IBS (IBS-D']","['placebo', 'Corticotropin-releasing factor (CRF', 'peripheral CRF', '5-mL saline solution (placebo) and CRF']","['Irritable bowel syndrome', 'IBS-D and HS', 'IBS-D, and CRF', 'Basal jejunal tryptase release', 'Abdominal pain', 'water flux, albumin output, tryptase release, stress hormones, cardiovascular and psychological responses, and abdominal pain', 'jejunal tryptase release, water flux, and albumin output', 'Basal luminal output of albumin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0010132', 'cui_str': 'Corticotropin-Releasing Hormone'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0022378', 'cui_str': 'Jejunal'}, {'cui': 'C0147080', 'cui_str': 'Tryptase'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}]",21.0,0.0765273,"RESULTS
Water flux did not change after placebo in IBS-D and HS but significantly increased after CRF in IBS-D (P = 0.007).","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Guilarte', 'Affiliation': ""Allergy Section, Department of Internal Medicine, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Vicario', 'Affiliation': ""Translational Mucosal Immunology Group, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'de Torres', 'Affiliation': ""Department of Pathology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Lobo', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Pigrau', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'González-Castro', 'Affiliation': ""Translational Mucosal Immunology Group, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Bruno K', 'Initials': 'BK', 'LastName': 'Rodiño-Janeiro', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Eloísa', 'Initials': 'E', 'LastName': 'Salvo-Romero', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Fortea', 'Affiliation': ""Translational Mucosal Immunology Group, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pardo-Camacho', 'Affiliation': ""Translational Mucosal Immunology Group, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Antolín', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Saperas', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Azpiroz', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Santos', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alonso-Cotoner', 'Affiliation': ""Laboratory of Neuro-Immuno-Gastroenterology, Digestive System Research Unit, Vall d'Hebron Institut de Recerca, Department of Gastroenterology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000789']
1738,32740409,Effect of direct renin inhibition on vascular function after long-term treatment with aliskiren in hypertensive and diabetic patients.,"OBJECTIVE
We tested the hypothesis that chronic treatment with the direct renin inhibitor aliskiren improves vascular function in resistance and conduit arteries of type two diabetic and hypertensive patients.
METHOD
Sixteen patients with mild essential hypertension and with a previous diagnosis of noninsulin-dependent diabetes mellitus were included in the study. Patients were then randomized to aliskiren (150 mg once daily, n = 9), or ramipril (5 mg once daily, n = 7). Each patient underwent a biopsy of the subcutaneous tissue and small arteries were dissected and mounted on a pressurized micromyograph to evaluate endothelium dependent vasorelaxation in response to acetylcholine ± N omega-nitro-L-arginine methyl ester hydrochloride in vessels precontracted with norepinephrine. Endothelial function has been quantified also in large conduit arteries by flow-mediated dilation.
RESULTS
A similar office blood pressure-lowering effect was observed with the two drugs, although changes in DBP were not statistically significant in the ramipril group. Aliskiren significantly improved endothelium-dependent relaxation in subcutaneous resistance arteries, as well as increased flow-mediated dilation in conduit arteries, whereas the effects induced by ramipril did not reach statistical significance. Only aliskiren significantly increased the expression of p1177-endothelial nitric oxide synthase in the endothelium. Both aliskiren and ramipril had a negligible effect on markers of oxidative stress.
CONCLUSION
Aliskiren restored endothelial function and induced a more prompt peripheral vasodilation in hypertensive and diabetic patients possibly through the increased production of nitric oxide via the enhanced expression and function of the active phosphorylated form of endothelial nitric oxide synthase.",2021,"A similar office blood pressure-lowering effect was observed with the two drugs, although changes in DBP were not statistically significant in the ramipril group.","['Sixteen patients with mild essential hypertension and with a previous diagnosis of noninsulin-dependent diabetes mellitus were included in the study', 'hypertensive and diabetic patients', 'type two diabetic and hypertensive patients']","['aliskiren', 'direct renin inhibition', 'Aliskiren', 'direct renin inhibitor aliskiren', 'ramipril', 'aliskiren and ramipril', 'N omega-nitro-L-arginine methyl ester hydrochloride', 'norepinephrine']","['markers of oxidative stress', 'endothelial function', 'expression of p1177-endothelial nitric oxide synthase', 'office blood pressure-lowering effect', 'changes in DBP', 'vascular function', 'endothelium-dependent relaxation']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1120110', 'cui_str': 'aliskiren'}, {'cui': 'C0373719', 'cui_str': 'Renin measurement'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0083536', 'cui_str': 'N(G)-Nitroarginine Methyl Ester'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0669365', 'cui_str': 'NOS3 protein, human'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",16.0,0.048178,"A similar office blood pressure-lowering effect was observed with the two drugs, although changes in DBP were not statistically significant in the ramipril group.","[{'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Savoia', 'Affiliation': ""Division of Cardiology, Clinical and Molecular Medicine Department, Sant'Andrea Hospital, Sapienza University of Rome, Rome.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'De Ciuceis', 'Affiliation': 'Clinica Medica, Department of Clinical and Experimental Sciences, University of Brescia, Brescia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Paini', 'Affiliation': 'Clinica Medica, Department of Clinical and Experimental Sciences, University of Brescia, Brescia.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Carletti', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Arrabito', 'Affiliation': ""Division of Cardiology, Clinical and Molecular Medicine Department, Sant'Andrea Hospital, Sapienza University of Rome, Rome.""}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Nicoletti', 'Affiliation': 'Section of Histology and Medical Embryology, Department of Anatomy, Histology, Forensic Medicine and Orthopaedics.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Mercantini', 'Affiliation': ""Surgical Department of Clinical Sciences Biomedical Technologies and Translational Medicine, Sant'Andrea Hospital, Sapienza University of Rome, Rome.""}, {'ForeName': 'Cira', 'Initials': 'C', 'LastName': 'Di Gioia', 'Affiliation': 'Department of Radiological, Oncological and Pathological Sciences.'}, {'ForeName': 'Allegra', 'Initials': 'A', 'LastName': 'Battistoni', 'Affiliation': ""Division of Cardiology, Clinical and Molecular Medicine Department, Sant'Andrea Hospital, Sapienza University of Rome, Rome.""}, {'ForeName': 'Sarassunta', 'Initials': 'S', 'LastName': 'Ucci', 'Affiliation': ""Division of Cardiology, Clinical and Molecular Medicine Department, Sant'Andrea Hospital, Sapienza University of Rome, Rome.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Filippini', 'Affiliation': 'Section of Histology and Medical Embryology, Department of Anatomy, Histology, Forensic Medicine and Orthopaedics.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Agabiti Rosei', 'Affiliation': 'Clinica Medica, Department of Clinical and Experimental Sciences, University of Brescia, Brescia.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Volpe', 'Affiliation': ""Division of Cardiology, Clinical and Molecular Medicine Department, Sant'Andrea Hospital, Sapienza University of Rome, Rome.""}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Muiesan', 'Affiliation': 'Clinica Medica, Department of Clinical and Experimental Sciences, University of Brescia, Brescia.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Rizzoni', 'Affiliation': 'Clinica Medica, Department of Clinical and Experimental Sciences, University of Brescia, Brescia.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Salvetti', 'Affiliation': 'Clinica Medica, Department of Clinical and Experimental Sciences, University of Brescia, Brescia.'}]",Journal of hypertension,['10.1097/HJH.0000000000002595']
1739,32740976,Alertness Training Improves Spatial Bias and Functional Ability in Spatial Neglect.,"OBJECTIVE
We conducted a multisite, randomized, double-blinded, controlled trial to examine the effectiveness of a digital health intervention targeting the intrinsic regulation of goal-directed alertness in patients with chronic hemispatial neglect.
METHODS
Forty-nine participants with hemispatial neglect, who demonstrated significant spatially biased attention after acquired brain injury, were randomly assigned to the experimental attention remediation treatment or the active control group. The participants engaged with the remotely administered interventions for 12 weeks. The primary outcome was spatial bias on the Posner cueing task (response time difference: left minus right target trials). Secondary outcomes included functional abilities (measured via the Catherine Bergego scale and Barthel index), spatial cognition, executive function, quality of life, and sleep. Assessments were conducted before and immediately after participation in the experimental intervention or control condition, and again after a 3-month no-contact period.
RESULTS
Compared with the active control group, the intervention group exhibited a significant improvement in the primary outcome, a reduction in spatially biased attention on the Posner cueing task (p = 0.010, Cohen's d = 0.96), in addition to significant improvements in functional abilities as measured on the Catherine Bergego and Barthel indices (p = 0.027, Cohen's d = 0.24).
INTERPRETATION
Our results demonstrate that our attention training program was effective in improving the debilitating attention deficits common to hemispatial neglect. This benefit generalized to improvements in real-world functional abilities. This safe, highly scalable, and self-administered treatment for hemispatial neglect might serve as a useful addition to the existing standard of care. ANN NEUROL 2020;88:747-758.",2020,"Compared with the active control group, the intervention group exhibited a significant improvement in the primary outcome-a reduction in spatially biased attention on the Posner cueing task (p=0.010, Cohen's d=0.96)-as well as significant improvements in functional abilities as measured on the Catherine Bergego and Barthel indices (p=0.027, Cohen's d=0.24).
","['patients with chronic hemispatial neglect', 'Forty-nine participants with hemispatial neglect that demonstrated significant spatially biased attention following acquired brain injury']","['experimental attention remediation treatment or active control group', 'digital health intervention', 'Alertness Training']","['spatial bias on the Posner cueing task (response time difference: left - right target trials', 'spatially biased attention on the Posner cueing task', 'Spatial Bias and Functional Ability in Spatial Neglect', 'functional abilities', 'Catherine Bergego and Barthel indices', 'debilitating attention deficits', 'functional abilities (measured via the Catherine Bergego scale and Barthel index), spatial cognition, executive function, quality of life and sleep']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0751421', 'cui_str': 'Hemispatial Neglect'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",49.0,0.274797,"Compared with the active control group, the intervention group exhibited a significant improvement in the primary outcome-a reduction in spatially biased attention on the Posner cueing task (p=0.010, Cohen's d=0.96)-as well as significant improvements in functional abilities as measured on the Catherine Bergego and Barthel indices (p=0.027, Cohen's d=0.24).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Van Vleet', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bonato', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital, Boston, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Fabara', 'Affiliation': 'Wyss Institute for Biologically Inspired Engineering, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Dabit', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Department of Psychology, University of Massachusetts, Boston, MA, USA.'}, {'ForeName': 'Antonio Luigi', 'Initials': 'AL', 'LastName': 'Bisogno', 'Affiliation': 'Clinica Neurologica, Department of Neuroscience, and Padova Neuroscience Center (PNC), University of Padova, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Merzenich', 'Affiliation': 'Department of Research and Development, Posit Science Inc, San Francisco, CA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Corbetta', 'Affiliation': 'Clinica Neurologica, Department of Neuroscience, and Padova Neuroscience Center (PNC), University of Padova, Italy.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'DeGutis', 'Affiliation': 'Boston Attention and Learning Laboratory, VA Boston Healthcare System, Boston, MA, USA.'}]",Annals of neurology,['10.1002/ana.25862']
1740,32741497,Pretreatment social network characteristics relate to increased risk of dropout and unfavorable outcomes among women in a residential treatment setting for substance use.,"Increased retention in residential treatment for substance use disorder (SUD) has been associated with more favorable clinical outcomes for residents. Yet SUD treatment dropout remains high. It is essential to uncover factors contributing to these high rates. Little is known about whether features of an individual's social network prior to treatment entry are related to number of days in treatment or to clinical status at treatment termination. To examine these relationships, we analyzed data from 241 women (58.5% Hispanic) entering an SUD residential treatment facility, who agreed to participate in a parent randomized control trial. We assessed characteristics of these women's social networks prior to treatment entry at baseline. We extracted clinician-determined progress at treatment termination and days in treatment two months after treatment entry from clinical records. Data-driven analyses using purposeful selection of predictors showed that the overall size of the social network was associated with increased likelihood of being classified as having achieved good clinical progress in treatment at termination and that number of drug users in the pretreatment social network was related to staying fewer days in treatment. Contrary to our hypothesis, we found no significant associations between other pretreatment social support network characteristics (i.e., social support) and treatment retention or clinical discharge status. Future research should examine how features of social networks change through treatment and how these changes relate to treatment outcomes.",2020,Data-driven analyses using purposeful selection of predictors showed that the overall size of the social network was associated with increased likelihood of being classified as having achieved good clinical progress in treatment at termination and that number of drug users in the pretreatment social network was related to staying fewer days in treatment.,"['women in a residential treatment setting for substance use', '241 women (58.5% Hispanic) entering an SUD residential treatment facility, who agreed to participate in a parent randomized control trial']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035189', 'cui_str': 'Residential Treatment'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],241.0,0.0245503,Data-driven analyses using purposeful selection of predictors showed that the overall size of the social network was associated with increased likelihood of being classified as having achieved good clinical progress in treatment at termination and that number of drug users in the pretreatment social network was related to staying fewer days in treatment.,"[{'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Arnaudova', 'Affiliation': 'Department of Psychiatry, University of California -, Los Angeles, United States of America.'}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Suzanne Dworak-Peck School of Social Work, University of Southern California, United States of America.'}, {'ForeName': 'Hortensia', 'Initials': 'H', 'LastName': 'Amaro', 'Affiliation': 'Herbert Wertheim College of Medicine and Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL, United States of America. Electronic address: hamaro@fiu.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108044']
1741,32741499,Acute and extended exposure to episodic future thinking in a treatment seeking addiction sample: A pilot study.,"Individuals with addictive disorders commonly exhibit a shortened temporal window (shortened period of time an individual can imagine into their own future), which interferes with treatment focusing on long-term sobriety or reductions in use. Episodic future thinking (EFT) involves generating personalized cues related to anticipated, positive future events. EFT has been shown to reduce impulsive decision-making and the reinforcing value of addictive substances; however, this has only been shown in nontreatment samples. The current study examined the feasibility and impact of a 1-week EFT protocol on decision-making and alcohol motivation in a sample of individuals receiving treatment for alcohol use disorder. We randomly assigned twenty-eight individuals currently enrolled in community-based alcohol use disorder treatment to either an EFT protocol or a control episodic recent thinking (ERT) protocol. Participants completed assessments of delay discounting, alcohol demand, craving, self-efficacy, consideration of consequences, and mindfulness at baseline, after 1 week of EFT practice, and at 1-week follow-up. We observed patterns of reductions in alcohol demand indices, delay discounting rates, and an increase in mindfulness after both acute (1 session) and extended (4 sessions) exposure to EFT. These proof-of-concept findings lay the foundation for a randomized controlled trial of EFT as a supplement to addictions treatment.",2020,"We observed patterns of reductions in alcohol demand indices, delay discounting rates, and an increase in mindfulness after both acute (1 session) and extended (4 sessions) exposure to EFT.","['individuals receiving treatment for alcohol use disorder', 'Individuals with addictive disorders']","['EFT protocol', 'Episodic future thinking (EFT', 'community-based alcohol use disorder treatment to either an EFT protocol or a control episodic recent thinking (ERT) protocol', 'EFT']","['delay discounting, alcohol demand, craving, self-efficacy, consideration of consequences, and mindfulness', 'alcohol demand indices, delay discounting rates', 'decision-making and alcohol motivation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",28.0,0.0202314,"We observed patterns of reductions in alcohol demand indices, delay discounting rates, and an increase in mindfulness after both acute (1 session) and extended (4 sessions) exposure to EFT.","[{'ForeName': 'Herry', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': ""Peter Boris Centre for Addictions Research, McMaster University/St. Joseph's Healthcare Hamilton. Electronic address: patelhn@mcmaster.ca.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Amlung', 'Affiliation': ""Peter Boris Centre for Addictions Research, McMaster University/St. Joseph's Healthcare Hamilton; Michael G. DeGroote Centre for Medicinal Cannabis Research, McMaster University; Department of Psychiatry & Behavioural Neurosciences, McMaster University.""}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108046']
1742,32741502,Oxytocin-enhanced group therapy for methamphetamine use disorder: Randomized controlled trial.,"BACKGROUND
Methamphetamine (METH) use is a public health crisis that disproportionately affects men who have sex with men (MSM). There are currently no FDA-approved pharmacological interventions to treat methamphetamine use disorder (MUD). MUD is associated with social impairments and extremely high treatment attrition rates. Administration of oxytocin, a neuropeptide involved in social attachment, may be a novel approach to addressing these issues. Moreover, oxytocin administration has shown promise for reducing METH-related addictive behavior in animal models, but has not yet been investigated in clinical trials for MUD. Last, oxytocin is known to modulate stress responsivity via regulation of the autonomic nervous system, which is dysregulated in METH users. We hypothesize that oxytocin, in combination with group psychotherapy, will increase treatment engagement, reduce addiction behavior, and mitigate stress hyperreactivity.
METHODS
This is a randomized, double blind trial of oxytocin 40-IU (n = 24) or placebo (n = 24) administered intranasally prior to each of six weekly motivational interviewing group therapy (MIGT) sessions for MUD in MSM.
PRIMARY OUTCOME
(a) session attendance.
SECONDARY OUTCOMES
(b) group cohesion, (c) anxiety, (d) METH craving, (e) METH use, and (f) in-session cardiac physiology.
RESULTS
Participants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014. There was a small effect of oxytocin on group cohension, but not anxiety or craving. METH use did not change over the six-week MIGT course in either treatment arm. Participants receiving oxytocin had lower average heart rates during MIGT sessions and higher heart rate variability. There were positive main effects of MIGT over Time regardless of study drug.
CONCLUSIONS
This evidence, and the lack of any serious adverse events, suggests that oxytocin may safely increase treatment attendance. One possible mechanism by which it may do so is its modulation of the autonomic nervous system. Further investigation is warranted.",2020,"RESULTS
Participants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014.","['methamphetamine use disorder', 'men who have sex with men (MSM']","['motivational interviewing group therapy (MIGT) sessions for MUD in MSM', 'oxytocin', 'oxytocin 40-IU (n\xa0=\xa024) or placebo', 'MIGT', 'Methamphetamine (METH', 'Oxytocin-enhanced group therapy', 'placebo']","['addiction behavior', 'b) group cohesion, (c) anxiety, (d) METH craving', 'therapy attendance', 'average heart rates', 'heart rate variability', 'anxiety or craving', 'a) session attendance']","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.674374,"RESULTS
Participants receiving oxytocin had significantly higher group therapy attendance than those receiving placebo, OR 3.26, 95% CI [1.27-8.41], p = .014.","[{'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Stauffer', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America; Portland Veterans Affairs Medical Center & Oregon Health and Science University, United States of America. Electronic address: christopher.stauffer@va.gov.'}, {'ForeName': 'Jenna M', 'Initials': 'JM', 'LastName': 'Moschetto', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McKernan', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Meinzer', 'Affiliation': 'Slalom Consulting, LLC, United States of America.'}, {'ForeName': 'Chavy', 'Initials': 'C', 'LastName': 'Chiang', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Rapier', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hsiang', 'Affiliation': 'University of California, San Francisco, United States of America.'}, {'ForeName': 'Jerika', 'Initials': 'J', 'LastName': 'Norona', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borsari', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'San Francisco Veterans Affairs Medical Center, United States of America; University of California, San Francisco, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108059']
1743,32741505,A randomized trial of an integrated cognitive behavioral treatment protocol for adolescents receiving home-based services for co-occurring disorders.,"The current study conducted a preliminary test of whether community mental health clinic staff could implement a multicomponent cognitive behavioral treatment, developed for adolescents with substance misuse (alcohol and/or marijuana) and comorbid psychiatric symptoms. We randomized a total of 111 families, with an adolescent 12-18 years old, referred to a home-based services program for youth with co-occurring substance use and mental health problems, to receive treatment from either masters-level therapists who received intensive cognitive behavioral therapy (I-CBT) training or from masters-level therapists who took part in a typical brief continuing education-style CBT workshop (treatment as usual, or TAU). Each family's therapist and insurance company determined the frequency and intensity of treatment. We administered follow-up assessments at 3, 6, and 12 months. There was a small, but not statistically significant, reduction in the percent days of heavy drinking and marijuana use over time for both conditions, with the overall effect across the three follow-up points favoring the I-CBT condition. There were no differences on alcohol use days or other drug use. There was also a small, but nonsignificant, positive effect over time on externalizing symptoms, depressed mood, and anxiety, favoring the I-CBT condition. Youth in the I-CBT condition relative to TAU had significantly fewer juvenile justice contacts, while the pattern of costly service use varied, with higher rates at 6-month and lower rates at 12-month follow-ups. If therapists pay greater attention to parent training and provide more parent-adolescent communication sessions, outcomes may improve above standard community care. Training enhancements, to better meet the needs of community therapists and their clinic settings, may also produce better overall results for parents and adolescents.",2020,"There was a small, but not statistically significant, reduction in the percent days of heavy drinking and marijuana use over time for both conditions, with the overall effect across the three follow-up points favoring the I-CBT condition.","['adolescents with substance misuse (alcohol and/or marijuana) and comorbid psychiatric symptoms', 'adolescents receiving home-based services for co-occurring disorders', 'community mental health clinic staff', '111 families, with an adolescent 12-18\xa0years old, referred to a home-based services program for youth with co-occurring substance use and mental health problems, to receive treatment from either masters-level therapists who received']","['integrated cognitive behavioral treatment protocol', 'multicomponent cognitive behavioral treatment', 'intensive cognitive behavioral therapy (I-CBT) training or from masters-level therapists who took part in a typical brief continuing education-style CBT workshop (treatment as usual, or TAU']","['externalizing symptoms, depressed mood, and anxiety', 'juvenile justice contacts']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013626', 'cui_str': 'Continuing Education'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3146221', 'cui_str': 'Juvenile'}, {'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",111.0,0.0500393,"There was a small, but not statistically significant, reduction in the percent days of heavy drinking and marijuana use over time for both conditions, with the overall effect across the three follow-up points favoring the I-CBT condition.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wolff', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America; Rhode Island Hospital, Providence, RI, United States of America. Electronic address: Jennifer_Wolff@Brown.edu.'}, {'ForeName': 'Christianne', 'Initials': 'C', 'LastName': 'Esposito-Smythers', 'Affiliation': 'George Mason University, United States of America.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Frazier', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America; Emma Pendleton Bradley Hospital, Riverside, RI, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stout', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America; Decision Sciences Institute, United States of America.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Gomez', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Massing-Schaffer', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Nestor', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America.'}, {'ForeName': 'Shayna', 'Initials': 'S', 'LastName': 'Cheek', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Graves', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Yen', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Hunt', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America; Emma Pendleton Bradley Hospital, Riverside, RI, United States of America.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Brown University, Department of Psychiatry and Human Behavior, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108055']
1744,32747302,Maintenance treatment with fluoropyrimidine plus bevacizumab versus fluoropyrimidine alone after induction chemotherapy for metastatic colorectal cancer: The BEVAMAINT - PRODIGE 71 - (FFCD 1710) phase III study.,"BACKGROUND
Maintenance treatments with fluoropyrimidine alone or combined with bevacizumab after induction chemotherapy are two standard options in first-line metastatic colorectal cancer (mCRC). However, no trial has compared these two maintenance regimens.
METHODS
BEVAMAINT is a multicenter, open-label, randomized phase III trial comparing fluoropyrimidine alone or plus bevacizumab as maintenance treatment after induction polychemotherapy in mCRC. The primary endpoint is the time-to-treatment failure (TTF), calculated from date of randomization to first radiological progression, death, start of a new chemotherapy regimen (different from induction or maintenance chemotherapy) or end of maintenance treatment without introduction of further chemotherapy. We expect a 2-month TTF improvement from 6 months in the monotherapy arm to 8 months in the combination arm (hazard ratio [HR], 0.75). Based on a two-sided α risk of 5% and a power of 80%, using Schoenfeld method, 379 events are required (planned enrolment, 400 patients). Patients with mCRC, whose disease is measurable according to RECIST 1.1 criteria and controlled (objective response or stable disease) - but remains unresectable - after 4 to 6 months of induction polychemotherapy (doublet or triplet chemotherapy with or without anti-EGFR or bevacizumab), and who have recovered from limiting adverse events of induction polychemotherapy are eligible for randomization. Randomization is stratified according to center, response to induction chemotherapy (objective response vs stable disease), ECOG performance status (0-1 vs 2), maintenance fluoropyrimidine (5-fluorouracil vs capecitabine) and primary tumor status (resected vs not). Capecitabine or bolus and infusional 5-fluorouracil plus folinic acid (simplified LV5FU2 regimen) are both accepted for maintenance chemotherapy, at investigator's discretion. Clinical evaluation, tumor imaging, carcinoembryonic antigen and circulating tumor DNA dosages are planned at enrolment and every 9 weeks. The maintenance treatment will be discontinued in the event of unbearable toxicity, progression or patient refusal. After maintenance discontinuation, reintroduction of induction polychemotherapy is recommended; otherwise a second-line treatment is started. The enrolment has begun in January 2020.",2020,"Randomization is stratified according to center, response to induction chemotherapy (objective response vs stable disease), ECOG performance status (0-1 vs 2), maintenance fluoropyrimidine (5-fluorouracil vs capecitabine) and primary tumor status (resected vs not).","['first-line metastatic colorectal cancer (mCRC', 'metastatic colorectal cancer']","['fluoropyrimidine (5-fluorouracil vs capecitabine', 'fluoropyrimidine plus bevacizumab', 'Capecitabine or bolus and infusional 5-fluorouracil plus folinic acid (simplified LV5FU2 regimen', 'fluoropyrimidine alone or plus bevacizumab', 'fluoropyrimidine alone', 'induction polychemotherapy (doublet or triplet chemotherapy with or without anti-EGFR or bevacizumab', 'fluoropyrimidine alone or combined with bevacizumab']","['time-to-treatment failure (TTF), calculated from date of randomization to first radiological progression, death, start of a new chemotherapy regimen (different from induction or maintenance chemotherapy) or end of maintenance treatment without introduction of further chemotherapy']","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0041095', 'cui_str': 'Triplets'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",,0.0301699,"Randomization is stratified according to center, response to induction chemotherapy (objective response vs stable disease), ECOG performance status (0-1 vs 2), maintenance fluoropyrimidine (5-fluorouracil vs capecitabine) and primary tumor status (resected vs not).","[{'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Manfredi', 'Affiliation': 'University of Bourgogne Franche-Comté, INSERM U123-1, university hospital Dijon, Gastroenterology unit, 14 rue Paul Gaffarel, 21000 Dijon, France. Electronic address: Sylvain.manfredi@chu-dijon.fr.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turpin', 'Affiliation': 'University hospital Claude Hurriez, CHR Lille, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Malka', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Barbier', 'Affiliation': 'CRGA FFCD, university of Bourgogne Franche-Comté, INSERM U123-1, Dijon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'Hôpital Européen Georges-Pompidou HEGP, AP-HP, University Paris Descartes, Paris, France.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Zaanan', 'Affiliation': 'Hôpital Européen Georges-Pompidou HEGP, AP-HP, University Paris Descartes, Paris, France.'}, {'ForeName': 'Laeticia', 'Initials': 'L', 'LastName': 'Dahan', 'Affiliation': 'University hospital la Timone, APHM, Marseille, France.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Lièvre', 'Affiliation': 'University hospital Rennes, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Phelip', 'Affiliation': 'University hospital Saint Etienne, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Michel', 'Affiliation': 'University hospital Rouen, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Hautefeuille', 'Affiliation': 'University hospital Amiens, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Legoux', 'Affiliation': 'General hospital Orléans, France.'}, {'ForeName': 'Côme', 'Initials': 'C', 'LastName': 'Lepage', 'Affiliation': 'University of Bourgogne Franche-Comté, INSERM U123-1, university hospital Dijon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'University hospital Poitiers, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Aparicio', 'Affiliation': 'University hospital Saint Louis, APHP, Paris, France.'}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.06.034']
1745,32748184,Comparison Between Intravenous Nalbuphine and Lidocaine in Reducing Propofol-Induced Injection Pain During Gastroscopy: A Randomized Controlled Trial.,"INTRODUCTION
Intravenous propofol anesthesia is widely used in painless endoscopy. However, propofol injection pain is a common adverse effect. This study investigated the effects of nalbuphine and lidocaine in reducing propofol-induced injection pain.
METHODS
In this double-blind, randomized study, 330 patients were randomly divided into three groups by using a random number table: the nalbuphine group (N), lidocaine group (L), and control group (C). The N, L, and C groups received either 0.1 mg/kg nalbuphine, 0.5 mg/kg lidocaine, or an equivalent volume of normal saline, respectively, as pretreatment drug. Then propofol was manually injected. The primary outcome of this study was the incidence of propofol-induced injection pain, and secondary outcomes included the severity of propofol-induced injection pain, vital signs, and adverse events, including hypotension, bradycardia (< 50 beats/min), hypoxemia (SpO 2 < 90%), drowsiness, physical movement, and cough.
RESULTS
The percentages of patients with propofol injection pain were higher in group C than in group N and group L (64, 34, and 27%, respectively, p < 0.05). The percentage of patients with severe pain after propofol injection was significantly higher in group C than in group N and group L (12, 1, and 0%, respectively, p < 0.05). The doses of propofol in group C and group L were significantly higher than that in group N. More patients suffered hypoxemia in group N than in group C and group L. Then, less patients got physical movement and cough in group N.
CONCLUSIONS
Pretreatment with nalbuphine 0.1 mg/kg was effective in reducing propofol-induced injection pain and propofol consumption. Propofol combined with nalbuphine can be safely and effectively used during gastroscopy.
TRIAL REGISTRATION
Chinese Clinical Trial Registry; ChiCTR1900025438.",2020,"The percentage of patients with severe pain after propofol injection was significantly higher in group C than in group N and group L (12, 1, and 0%, respectively, p < 0.05).","['painless endoscopy', '330 patients']","['Propofol combined with nalbuphine', 'nalbuphine', 'Propofol-Induced Injection Pain', 'lidocaine', 'nalbuphine and lidocaine', 'Intravenous propofol anesthesia', '0.1\xa0mg/kg nalbuphine, 0.5\xa0mg/kg lidocaine', 'propofol', 'Nalbuphine and Lidocaine']","['incidence of propofol-induced injection pain', 'suffered hypoxemia', 'severity of propofol-induced injection pain, vital signs, and adverse events, including hypotension, bradycardia (<\u200950 beats/min), hypoxemia (SpO 2 \u2009<\u200990%), drowsiness, physical movement, and cough', 'propofol injection pain', 'percentage of patients with severe pain']","[{'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C4282968', 'cui_str': 'Propofol Injection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",330.0,0.0736753,"The percentage of patients with severe pain after propofol injection was significantly higher in group C than in group N and group L (12, 1, and 0%, respectively, p < 0.05).","[{'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Jinjuan', 'Initials': 'J', 'LastName': 'Duan', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Cuiyu', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui Province, People's Republic of China. luyao-mz@163.com.""}]",Pain and therapy,['10.1007/s40122-020-00188-y']
1746,32754804,Efficacy of GAD-alum immunotherapy associated with HLA-DR3-DQ2 in recently diagnosed type 1 diabetes.,"AIMS/HYPOTHESIS
The aim of this study was to determine if retention of C-peptide following immunotherapy using recombinant GAD65 conjugated to aluminium hydroxide (GAD-alum) is influenced by HLA risk haplotypes DR3-DQ2 and DR4-DQ8.
METHODS
HLA-dependent treatment effect of GAD-alum therapy on C-peptide retention in individuals with recent-onset type 1 diabetes was evaluated using individual-level patient data from three placebo-controlled, randomised clinical trials using a mixed repeated measures model.
RESULTS
A significant and dose-dependent effect was observed in individuals positive for the genotypes that include HLA-DR3-DQ2 but not HLA-DR4-DQ8 and in the broader subgroup of individuals positive for all genotypes that include HLA-DR3-DQ2 (i.e. including those also positive for HLA-DR4-DQ8). Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
CONCLUSIONS/INTERPRETATION
GAD65-specific immunotherapy has a significant effect on C-peptide retention in individuals with recent-onset type 1 diabetes who have the DR3-DQ2 haplotype. Graphical abstract.",2020,"Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
","['individuals with recent-onset type 1 diabetes who have the DR3-DQ2 haplotype', 'individuals with recent-onset type 1 diabetes']","['placebo', 'recombinant GAD65 conjugated to aluminium hydroxide (GAD-alum', 'GAD-alum therapy', 'GAD-alum immunotherapy']",['HLA-DR3-DQ2'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0018591', 'cui_str': 'Haplotypes'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0019772', 'cui_str': 'HLA-DR3 antigen'}]",,0.276531,"Higher doses (three or four injections) showed a treatment effect ratio of 1.596 (95% CI 1.132, 2.249; adjusted p = 0.0035) and 1.441 (95% CI 1.188, 1.749; adjusted p = 0.0007) vs placebo for the two respective HLA subgroups.
","[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Hannelius', 'Affiliation': 'Diamyd Medical AB, Kungsgatan 29, 111 56, Stockholm, Sweden. ulf.hannelius@diamyd.com.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Beam', 'Affiliation': 'Department of Biomedical Sciences, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Ludvigsson', 'Affiliation': ""Crown Princess Victoria Children's Hospital, Linköping, Sweden. Johnny.Ludvigsson@liu.se.""}]",Diabetologia,['10.1007/s00125-020-05227-z']
1747,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND
With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS
A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS
After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6 %), five cases in the Lianhua group (8.6 %), and seven cases in the western medicine group (11.1 %). There was no statistical differences in this rate among the three groups (P > 0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION
The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tina_yai@126.com.""}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1748,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
1749,32781397,Parental sensitivity mediates the sustained effect of Attachment and Biobehavioral Catch-up on cortisol in middle childhood: A randomized clinical trial.,"IMPORTANCE
Parenting interventions have been found to normalize cortisol regulation among high-risk children early in development; it is important to investigate the sustainability of these effects and their mechanisms, given the maladaptive outcomes associated with cortisol dysregulation.
OBJECTIVE
To determine whether the Attachment and Biobehavioral Catch-up (ABC) intervention, implemented in infancy, predicts cortisol regulation in middle childhood via changes in early parental sensitivity.
DESIGN
Double blind randomized clinical trial design; started January 2006, the follow-up for this project concluded March 2016.
SETTING
Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city.
PARTICIPANTS
103 parent-child dyads (45.6% female children) with histories of child protective services involvement, randomly assigned to receive ABC (n = 45) or a control intervention (n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years).
INTERVENTIONS
Both conditions included 10-week, in-home, manualized interventions. The experimental condition, ABC, has 3 primary targets for parents: increasing nurturance to child distress, increasing following the child's lead, and decreasing frightening behavior. The control intervention, Developmental Education for Families (DEF), is an adaptation of a program focused on enhancing cognitive and language development.
MAIN OUTCOMES AND MEASURES
Parental sensitivity was coded from a semi-structured interaction task between the parent and child in early childhood. Middle childhood diurnal cortisol slopes were modeled by collecting salivary cortisol samples from children at wake-up and bedtime over the course of 3 consecutive days.
RESULTS
ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002. The indirect effect of ABC on cortisol regulation via sensitivity was significant, β = -0.15, p = .038.
CONCLUSIONS AND RELEVANCE
ABC has an indirect effect on middle childhood diurnal cortisol regulation via parental sensitivity; future research should seek to determine how this enhanced neurobiological regulation relates to children's behavioral, socioemotional, and psychological outcomes.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT02093052.",2020,"RESULTS
ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","['Parents of children under age 2 referred from child protective services agencies in a large, mid-Atlantic city', ""n = 58); in infancy, the children's ages ranged from 1.60 to 25.30 months (M = 9.87 months); at the middle childhood follow-up, they ranged from 8.0 to 11.0 years old (M = 8.52 years"", 'middle childhood', '103 parent-child dyads (45.6% female children) with histories of child protective services involvement']","['control intervention, Developmental Education for Families (DEF', 'Attachment and Biobehavioral Catch-up (ABC) intervention', 'ABC', 'control intervention']","['Middle childhood diurnal cortisol slopes', 'cortisol regulation via sensitivity']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0681158', 'cui_str': 'Child Welfare Agencies'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0870604', 'cui_str': 'Female child'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0231617', 'cui_str': 'Catch'}]","[{'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0395333,"RESULTS
ABC participation in infancy was associated with increased parental sensitivity post-intervention, β = 0.28, p = .004, and this increased sensitivity predicted steeper decline across the day in children's cortisol concentration in middle childhood, β = -.53, p = .002.","[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Garnett', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States. Electronic address: mgarnett@udel.edu.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Bernard', 'Affiliation': 'Stony Brook University, Psychology B Building, Stony Brook, NY, 11794, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hoye', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Zajac', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Dozier', 'Affiliation': 'University of Delaware, Department of Psychological and Brain Sciences, 108 Wolf Hall, Newark, DE, 19718, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104809']
1750,32383806,Linking data from a large clinical trial with the Australian Cerebral Palsy Register.,"AIM
To link data from a large maternal perinatal trial with the Australian Cerebral Palsy Register (ACPR) to identify children with cerebral palsy (CP).
METHOD
Deidentified data from the Australasian Collaborative Trial of Magnesium Sulphate (ACTOMgSO 4 ) and the ACPR were linked. Children born from 1996 to 2000 at Australian hospitals who survived and had 2-year paediatric assessments were included. Children identified with CP in: (1) both the ACTOMgSO 4 (2y) and the ACPR (5y), (2) the ACTOMgSO 4 only, and (3) the ACPR only were compared.
RESULTS
We included 913 children (492 males, 421 females; mean gestational age at birth 27.8wks [standard deviation 2.1wks]; range 23.0-40.0wks). Eighty-four children received a CP diagnosis: 35 by the ACTOMgSO 4 and the ACPR, 29 by the ACTOMgSO 4 only, and 20 by the ACPR only. The ACTOMgSO 4 diagnosed 76.2% (95% confidence interval [CI] 65.9-84.1) and the ACPR identified 65.5% (95% CI 54.7-74.9). Children born in states/territories with long-standing versus more recently established registers were more likely to be included on the ACPR (p<0.05).
INTERPRETATION
Linking deidentified perinatal trial data with the ACPR was achieved. Limitations of both strategies for identifying children with CP in this era (late 1990s and early 2000s) probably explain many of the differences observed, and inform future linkage studies and evaluations of CP-preventive interventions.
WHAT THIS PAPER ADDS
Randomized trial data were linked with the Australian Cerebral Palsy Register. Trial (2y) and register (up to 5y) diagnoses of cerebral palsy (CP) differed. States with long-standing registers were more likely to include children with CP.",2020,The ACTOMgSO 4 diagnosed 76.2% (95% confidence interval [CI] 65.9-84.1) and the ACPR identified 65.5% (95% CI 54.7-74.9).,"['children with cerebral palsy (CP', '913 children (492 males, 421 females; mean gestational age at birth 27.8wks', 'Children born from 1996 to 2000 at Australian hospitals who survived and had 2-year paediatric assessments were included']","['CP diagnosis', 'Magnesium Sulphate']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]",[],913.0,0.0522781,The ACTOMgSO 4 diagnosed 76.2% (95% confidence interval [CI] 65.9-84.1) and the ACPR identified 65.5% (95% CI 54.7-74.9).,"[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Shepherd', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mcintyre', 'Affiliation': 'Cerebral Palsy Alliance, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Smithers-Sheedy', 'Affiliation': 'Cerebral Palsy Alliance, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Ashwood', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Te Velde', 'Affiliation': 'Cerebral Palsy Alliance, Discipline of Child and Adolescent Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lex W', 'Initials': 'LW', 'LastName': 'Doyle', 'Affiliation': ""Victorian Infant Brain Studies, The Murdoch Children's Research Institute, Melbourne, Vic, Australia.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Middleton', 'Affiliation': 'SA Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Crowther', 'Affiliation': 'Discipline of Obstetrics and Gynaecology, Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia.'}]",Developmental medicine and child neurology,['10.1111/dmcn.14556']
1751,32791894,Effects of Olanzapine Combined With Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3 Study.,"OBJECTIVE
A combination of olanzapine and the opioid receptor antagonist samidorphan is under development for the treatment of schizophrenia and bipolar I disorder. The single-tablet combination treatment is intended to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain. In this phase 3 double-blind trial, the authors evaluated the weight profile of combined olanzapine/samidorphan compared with olanzapine in patients with schizophrenia.
METHODS
Adults (ages 18‒55 years) with schizophrenia were randomly assigned to receive either combination treatment with olanzapine and samidorphan or olanzapine treatment for 24 weeks. Primary endpoints were percent change from baseline in body weight and proportion of patients with ≥10% weight gain at week 24. The key secondary endpoint was the proportion of patients with ≥7% weight gain. Waist circumference and fasting metabolic laboratory parameters were also measured.
RESULTS
Of 561 patients who underwent randomization (olanzapine/samidorphan combination, N=280; olanzapine, N=281), 538 had at least one postbaseline weight assessment. At week 24, the least squares mean percent weight change from baseline was 4.21% (SE=0.68) in the olanzapine/samidorphan group and 6.59% (SE=0.67) in the olanzapine group (the difference of -2.38% [SE=0.76] was significant). Significantly fewer patients in the olanzapine/samidorphan combination group compared with the olanzapine group had weight gain ≥10% (17.8% and 29.8%, respectively; number needed to treat [NNT]=7.29; odds ratio=0.50) and weight gain ≥7% (27.5% and 42.7%, respectively; NNT=6.29; odds ratio=0.50). Increases in waist circumference were smaller in the olanzapine/samidorphan combination group compared with the olanzapine group. Schizophrenia symptom improvement was similar between treatment groups. Adverse events (in ≥10% of the groups) in the olanzapine/samidorphan and olanzapine groups included weight gain (24.8% and 36.2%), somnolence (21.2% and 18.1%), dry mouth (12.8% and 8.0%), and increased appetite (10.9% and 12.3%). Metabolic changes were small and similar between treatments.
CONCLUSIONS
Olanzapine/samidorphan combination treatment was associated with significantly less weight gain and smaller increases in waist circumference than olanzapine and was well tolerated. The antipsychotic efficacy of the combination treatment was similar to that of olanzapine monotherapy.",2020,Increases in waist circumference were smaller in the olanzapine/samidorphan combination group compared with the olanzapine group.,"['561 patients who underwent randomization (olanzapine/samidorphan combination, N=280', 'Schizophrenia', ' N=281), 538 had at least one postbaseline weight assessment', 'patients with schizophrenia', 'Adults (ages 18‒55 years) with schizophrenia']","['olanzapine', 'olanzapine/samidorphan combination', 'olanzapine/samidorphan', 'Olanzapine Combined With Samidorphan', 'Olanzapine/samidorphan combination', 'olanzapine and samidorphan or olanzapine', 'olanzapine/samidorphan and olanzapine', ' olanzapine', 'olanzapine monotherapy']","['proportion of patients with ≥7% weight gain', 'waist circumference', 'Adverse events', 'body weight and proportion of patients with ≥10% weight gain', 'Metabolic changes', 'Waist circumference and fasting metabolic laboratory parameters', 'weight gain', 'tolerated', 'Schizophrenia symptom improvement', 'appetite', 'Weight Gain', 'weight profile', 'somnolence', 'antipsychotic efficacy', 'dry mouth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",561.0,0.0487214,Increases in waist circumference were smaller in the olanzapine/samidorphan combination group compared with the olanzapine group.,"[{'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Silverman', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'DiPetrillo', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Hopkinson', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDonnell', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}, {'ForeName': 'René S', 'Initials': 'RS', 'LastName': 'Kahn', 'Affiliation': 'Department of Psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y. (Correll); Department of Psychiatry and Molecular Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y. (Correll); Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin (Correll); Thriving Mind South Florida, Miami (Newcomer); Department of Psychiatry, Washington University School of Medicine, St. Louis (Newcomer); Alkermes, Inc., Waltham, Mass. (Silverman, DiPetrillo, Graham, Jiang, Du, Simmons, Hopkinson); Alkermes Pharma Ireland, Dublin (McDonnell); and Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Kahn).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2020.19121279']
1752,32797232,A Randomized Comparative Trial of Targeted Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection for the Treatment of Unilateral Cervical Radicular Pain: Six-Month Results.,"OBJECTIVES
Compare the effectiveness of catheter-directed cervical interlaminar epidural steroid injection (C-CIESI) with triamcinolone to cervical transforaminal steroid injection (CTFESI) with dexamethasone for the treatment of refractory unilateral radicular pain.
DESIGN
Prospective, randomized, comparative trial.
METHODS
Primary outcome: proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain"" (the greater of arm vs neck) at one month postinjection. Secondary outcomes: ≥30% Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved.""
RESULTS
One hundred twenty participants (55.6% females, 52.3 ± 12.5 years of age, BMI 28.2 ± 6.5 kg/m2), were enrolled. The proportions of participants who experienced ≥50% pain reduction at one, three, and six months were 68.5% (95% CI = 54.9-79.5%), 59.3% (95% CI = 45.7-71.6%), and 60.8% (95% CI = 46.7-73.2%), respectively, in the C-CIESI group compared with 49.1% (95% CI = 36.4-62.0%), 46.4% (95% CI = 33.8-59.6%), and 51.9% (95% CI = 38.4-65.2%), respectively, in the CTFESI group. The between-group difference at one month was significant (P = 0.038). The proportions of participants who experienced a ≥30% NDI-5 score improvement were 64.0% (95% CI = 49.8-76.1%) and 54.9% (95% CI = 41.1-68.0%) in the C-CIESI and CTFESI groups (P = 0.352). Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
CONCLUSIONS
Both C-CIESI with triamcinolone and CTFESI with dexamethasone are effective in reducing pain and disability associated with refractory unilateral cervical radiculopathy in a substantial proportion of participants for at least six months.",2020,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","['One hundred twenty participants (55.6% females, 52.3\u2009±\u200912.5\u2009years of age, BMI 28.2\u2009±\u20096.5\u2009kg/m2), were enrolled', 'Unilateral Cervical Radicular Pain']","['triamcinolone', 'catheter-directed cervical interlaminar epidural steroid injection (C-CIESI', 'dexamethasone', 'triamcinolone and CTFESI with dexamethasone', 'Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection']","['NDI-5 score improvement', 'pain reduction', 'pain and disability', 'PGIC improvement', 'Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved', 'proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}]","[{'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",120.0,0.176804,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'McCormick', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Conger', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Beau P', 'Initials': 'BP', 'LastName': 'Sperry', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Petersen', 'Affiliation': 'Alabama College of Osteopathic Medicine, Dothan, Alabama.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Salazar', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Shellie', 'Initials': 'S', 'LastName': 'Cunningham', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Michael Henrie', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Bisson', 'Affiliation': 'Department of Neurosurgery, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kendall', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa242']
1753,32739569,Randomized Controlled Trial of Advance Notification Phone Calls vs Text Messages Prior to Mailed Fecal Test Outreach.,"BACKGROUND & AIMS
Mailing fecal immunochemical test (FITs) to individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening. Little is known about how phone-based advance notifications (primers) affect the effectiveness of these programs.
METHODS
We performed a prospective study of patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT. Participants were randomly assigned to groups that received a live phone call primer (n = 1203) or a text message primer (n = 1622), from June through December 2018. The participants were then mailed a FIT kit, followed by 2 automated calls, and live reminder calls delivered by the care team. The main outcome was completion of FIT within 3 months of assignment to the live phone call or text message group.
RESULTS
Participants had FIT completion rate of 16.8%, a mean age of 58 years, and 80% were Latino. In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%). Between-group differences increased to 7.3% points (95% CI, 3.6%-11.0%) in the per-protocol analysis of 2144 participants reached by the text message (1320/1622, 81%), live call (438/1203, 36%), or voice message (386/1203, 32%). This rate increased to 14.9% points (95% CI; 9.6%-20.1%) in the per-protocol analysis of 1758 participants reached by the text message or reached by the live call.
CONCLUSIONS
In a randomized trial, advance notification live phone calls outperformed text messages in reminding health center patients who had not previously completed a FIT to complete a mailed FIT. Clinicaltrials.gov no: NCT03167125.",2020,"In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%).","['individuals who are due for screening (mailed FIT outreach) increases colorectal cancer (CRC) screening', 'patients at a large urban health center, 50-75 years old and due for screening, with no record of a prior FIT', 'reminding health center patients who had not previously completed a FIT to complete a mailed FIT']",['live phone call primer (n = 1203) or a text message primer'],"['FIT completion rate', 'FIT completion rates', 'voice message']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041933', 'cui_str': 'Urban Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332127', 'cui_str': 'No record of'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0206415', 'cui_str': 'Oligonucleotide Primers'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]",2825.0,0.236928,"In adjusted intention to treat analyses (n = 2825), FIT completion rates were higher in the patients assigned to receive a live phone call vs text message primer (percentage point difference, 3.3%; 95% CI, 0.4%-6.2%).","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon. Electronic address: gloria.d.coronado@kpchr.org.'}, {'ForeName': 'Denis B', 'Initials': 'DB', 'LastName': 'Nyongesa', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Escaron', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Younger', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Harbison', 'Affiliation': 'AltaMed Health Services, Los Angeles, California.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.053']
1754,32739611,Changes in technology acceptance among older people with dementia: the role of social robot engagement.,"OBJECTIVE
Emerging technologies such as social robots have shown to be effective in reducing loneliness and agitation for older people with dementia. However, the acceptance of technology (specifically social robots) was found to be low for older people with dementia. The current understanding of changes in technology acceptance following direct exposure is limited and lacks rigorous study design. This study examined the change in technology acceptance after a direct interaction with a humanoid social robot (Kabochan) that was deployed for long-term care facilities' residents with dementia.
METHODS
The technology acceptance was assessed using randomised control trials for a time frame of 32 weeks. A total of 103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong and were randomly allocated to either Kabochan-engagement group or control group. Participants in the engagement group interacted with Kabochan in an individual, non-facilitated approach. The behavioural engagement with Kabochan was observed by care workers and recorded into constructive engagement and non-engagement. Questionnaire surveys were taken placed at pre- and post-exposure with Kabochan to measure attitudes and beliefs towards technology. The questionnaire was based on previous studies on technology acceptance and included attitudes towards technology, perceived usefulness, perceived ease of use, technology self-efficacy, technology anxiety, and facilitating conditions.
RESULTS
Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2 = 0.043) in comparison to usual care group. Results further demonstrated that the magnitude of belief changes was related to the intensity of constructive behavioural engagement. Specifically, resident-robot behavioural engagement moderately improved attitudes towards technology (F = 11.62, p < 0.001, η p 2 = 0.11) and perceived usefulness (F = 5.75, p = 0.02, η p 2 = 0.06).
CONCLUSIONS
The study tentatively supports that exposure to Kabochan has potential for changing perceived ease of use but not for other beliefs and attitudes towards technology among long-term care residents with dementia. Direct engagement with a humanoid social robot might be promising in improving the perceived ease of use towards technology.",2020,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2 = 0.043) in comparison to usual care group.","['103 residents clinically diagnosed with dementia, with a mean age of 87.2 years (SD = 7.4), were recruited from seven long-term care facilities in Hong Kong', ""long-term care facilities' residents with dementia"", 'older people with dementia']","['humanoid social robot (Kabochan', 'humanoid social robot', 'Kabochan-engagement group or control group', 'Kabochan']","['Perceived ease of use', 'attitudes towards technology']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]",103.0,0.0256322,"Perceived ease of use was improved at week 32 for participants who interacted with Kabochan (F = 4.239, p = 0.042) with a small effect (η p 2 = 0.043) in comparison to usual care group.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ke', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong. Electronic address: kechen@hku.hk.'}, {'ForeName': 'Vivian Wei-Qun', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'Sau Po Centre on Ageing, the University of Hong Kong, Hong Kong; Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: wlou@hku.hk.'}, {'ForeName': 'Kelvin Cheng-Kian', 'Initials': 'KC', 'LastName': 'Tan', 'Affiliation': 'Social Work and Social Administration, the University of Hong Kong, Pok Fu Lam, Hong Kong. Electronic address: u3004055@connect.hku.hk.'}, {'ForeName': 'Man Yi', 'Initials': 'MY', 'LastName': 'Wai', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: gwai@skhwc.org.hk.'}, {'ForeName': 'Lai Lok', 'Initials': 'LL', 'LastName': 'Chan', 'Affiliation': 'Hong Kong Sheng Kung Hui Welfare Council Ltd, Hong Kong. Electronic address: llchan@skhwc.org.hk.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104241']
1755,32740188,Nurse-Implemented Goal-Directed Strategy to Improve Pain and Sedation Management in a Pediatric Cardiac ICU.,"OBJECTIVES
To assess the impact of a nurse-implemented goal-directed sedation strategy on patient care and nursing practice in a pediatric cardiac ICU.
DESIGN
Quality improvement project with a pre-post interval measurement plan.
SETTING
Thirty-one bed pediatric cardiac ICU in a freestanding tertiary care children's hospital.
PATIENTS
Postoperative pediatric cardiac surgery patients.
INTERVENTIONS
The implementation of cardiac-Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE), a nurse-implemented goal directed strategy to improve pain and sedation management in a pediatric cardiac ICU which included daily team discussion of the patient's trajectory of illness (acute, titration, or weaning phase), prescription of a sedation target score based on the patient's trajectory of illness, arousal assessments, and opioid and/or sedative titration. Withdrawal Assessment Scores were used to assess and manage iatrogenic withdrawal symptoms.
MEASUREMENTS AND MAIN RESULTS
Data related to opioid and sedation use, pain and sedation scores, and the occurrence and management of iatrogenic withdrawal symptoms were reviewed on 1,243 patients during four separate time periods: one pre-implementation and three discontinuous post-implementation time intervals. Patient age and complexity were consistent across the data collection periods. Post-implementation opioids and benzodiazepines use was reduced about 50% without a concomitant increase in the use of other sedative classes. Few post-intervention patients were discharged from the pediatric cardiac ICU or to home on methadone (pediatric cardiac ICU: pre 19% to post 3%; hospital: pre 12% to post 1.3%). Documentation of pain, sedation, and withdrawal scores became more consistent and nurses reported satisfaction with their patient's comfort management.
CONCLUSIONS
The implementation of a nurse-driven goal-directed plan such as cardiac-RESTORE to manage pediatric cardiac ICU patient pain and sedation is possible, sustainable, and associated with reduced sedative and methadone use.",2020,Post-implementation opioids and benzodiazepines use was reduced about 50% without a concomitant increase in the use of other sedative classes.,"['Postoperative pediatric cardiac surgery patients', ""Thirty-one bed pediatric cardiac ICU in a freestanding tertiary care children's hospital""]","['benzodiazepines', 'Sedation Titration', 'nurse-implemented goal-directed sedation strategy']","['Withdrawal Assessment Scores', 'opioid and sedation use, pain and sedation scores, and the occurrence and management of iatrogenic withdrawal symptoms', 'Documentation of pain, sedation, and withdrawal scores']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0179281', 'cui_str': 'Pediatric bed'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}]",1243.0,0.0880508,Post-implementation opioids and benzodiazepines use was reduced about 50% without a concomitant increase in the use of other sedative classes.,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Lincoln', 'Affiliation': ""Department of Cardiovascular and Critical Care Nursing Services, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Cardiovascular and Critical Care Nursing Services, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Lauren P', 'Initials': 'LP', 'LastName': 'Hartwell', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Kimberlee', 'Initials': 'K', 'LastName': 'Gauvreau', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Brenda L', 'Initials': 'BL', 'LastName': 'Dodsen', 'Affiliation': ""Information Services Department, Clinical Integration Architect, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'LaRovere', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Ravi R', 'Initials': 'RR', 'LastName': 'Thiagarajan', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Hickey', 'Affiliation': ""Department of Cardiovascular and Critical Care Nursing Services, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002505']
1756,32740192,Dexmedetomidine Sedation in Mechanically Ventilated Critically Ill Children: A Pilot Randomized Controlled Trial.,"OBJECTIVES
To assess the feasibility, safety, and efficacy of a sedation protocol using dexmedetomidine as the primary sedative in mechanically ventilated critically ill children.
DESIGN
Open-label, pilot, prospective, multicenter, randomized, controlled trial. The primary outcome was the proportion of sedation scores in the target sedation range in the first 48 hours. Safety outcomes included device removal, adverse events, and vasopressor use. Feasibility outcomes included time to randomization and protocol fidelity.
SETTING
Six tertiary PICUs in Australia and New Zealand.
PATIENTS
Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours.
INTERVENTIONS
Children randomized to dexmedetomidine received a dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1). Children randomized to usual care received sedation as determined by the treating clinician (but not dexmedetomidine), also targeted to light sedation.
MEASUREMENTS AND MAIN RESULTS
Sedation with dexmedetomidine as the primary sedative resulted in a greater proportion of sedation measurements in the light sedation range (State Behavioral Scale -1 to +1) over the first 48 hours (229/325 [71%] vs 181/331 [58%]; p = 0.04) and the first 24 hours (66/103 [64%] vs 48/116 [41%]; p < 0.001) compared with usual care. Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements. Median time to randomization after intubation was 6.0 hours (interquartile range, 2.0-9.0 hr) in the dexmedetomidine arm compared with 3.0 hours (interquartile range, 1.0-7.0 hr) in the usual care arm (p = 0.24).
CONCLUSIONS
A sedation protocol using dexmedetomidine as the primary sedative was feasible, appeared safe, achieved early, light sedation, and reduced midazolam requirements. The findings of this pilot study justify further studies of sedative agents in critically ill children.",2020,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"['Critically ill children, younger than 16 years old, requiring intubation and mechanical ventilation and expected to be mechanically ventilated for at least 24 hours', 'Mechanically Ventilated Critically Ill Children', 'critically ill children', 'Six tertiary PICUs in Australia and New Zealand', 'mechanically ventilated critically ill children']","['dexmedetomidine-based algorithm targeted to light sedation (State Behavioral Scale -1 to +1', 'Dexmedetomidine Sedation', 'dexmedetomidine', 'usual care received sedation as determined by the treating clinician (but not dexmedetomidine']","['hypotension and bradycardia', 'proportion of sedation scores', 'feasibility, safety, and efficacy', 'proportion of sedation measurements', 'light sedation range (State Behavioral Scale -1 to +1', 'time to randomization and protocol fidelity', 'device removal, adverse events, and vasopressor use', 'Cumulative midazolam dosage', 'Median time to randomization after intubation']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0752250', 'cui_str': 'Removal of device'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]",,0.154635,Cumulative midazolam dosage was significantly reduced in the dexmedetomidine arm compared with usual care (p = 0.002).There were more episodes of hypotension and bradycardia with dexmedetomidine (including one serious adverse event) but no difference in vasopressor requirements.,"[{'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Erickson', 'Affiliation': ""Paediatric Critical Care, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Millar', 'Affiliation': ""Paediatric Intensive Care Unit, Royal Children's Hospital, Melbourne, VIC, Australia.""}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Anderson', 'Affiliation': ""Paediatric Intensive Care Unit, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Marino S', 'Initials': 'MS', 'LastName': 'Festa', 'Affiliation': ""Kids Critical Care Research, The Children's Hospital at Westmead, Westmead, NSW, Australia.""}, {'ForeName': 'Lahn', 'Initials': 'L', 'LastName': 'Straney', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Yahya', 'Initials': 'Y', 'LastName': 'Shehabi', 'Affiliation': 'School of Clinical Sciences, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Debbie A', 'Initials': 'DA', 'LastName': 'Long', 'Affiliation': ""Paediatric Intensive Care Unit, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002483']
1757,32740476,Efficacy of Intragastric Balloon Placement and Botulinum Toxin Injection in Bariatric Endoscopy.,"BACKGROUND
To evaluate the results obtained from the combination of intragastric botulinum toxin A (IGBTA), intragastric balloon (IGB), and IGBTA(+)IGB in the treatment of obesity.
MATERIALS AND METHODS
Three separate treatment groups were set up. IGBTA, IGB, and IGBTA(+)IGB were administered to Group 1, 2, and 3, respectively. The body mass indexes (BMI) of patients were measured before and 6 months after the treatment. The intragroup and intergroup treatment results have been evaluated. P<0.05 was considered significant.
RESULTS
The mean BMI decreased by 1.6 kg/m in 40 patients who received IGBTA in group 1 (P<0.001), 3.95 kg/m in 42 patients who received IGB in group 2 (P<0.001), and 4.9 kg/m in 39 patients who received IGBTA and IGB in group 3 (P<0.001) after 6 months of treatment. The intolerance because of the application was the highest in group 3, followed by group 2.
CONCLUSION
The treatment was most successful in group 3 followed by group 2 and group 1, respectively. The authors recommend the group 3 treatment, provided that nausea, vomiting, and flatulence have a high index of probability in such a treatment. However, when deciding between group 1 and group 2 treatments, the authors recommend opting for group 2 treatment that shows to be more efficient.",2020,"The treatment was most successful in group 3 followed by group 2 and group 1, respectively.",['Bariatric Endoscopy'],"['intragastric botulinum toxin A (IGBTA), intragastric balloon (IGB), and IGBTA(+)IGB', 'IGBTA and IGB', 'IGB', 'Intragastric Balloon Placement and Botulinum Toxin Injection']","['mean BMI', 'nausea, vomiting, and flatulence']","[{'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",42.0,0.0453207,"The treatment was most successful in group 3 followed by group 2 and group 1, respectively.","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kanlioz', 'Affiliation': 'Private Beylikduzu Kolan Hospital, Clinic of General Surgery.'}, {'ForeName': 'Uğur', 'Initials': 'U', 'LastName': 'Ekici', 'Affiliation': 'Istanbul Gelişim University, Health Science Colleges, Istanbul.'}, {'ForeName': 'Faik', 'Initials': 'F', 'LastName': 'Tatli', 'Affiliation': 'Department of General Surgery, Faculty of Medicine, Harran University, Şanliurfa.'}, {'ForeName': 'Turgay', 'Initials': 'T', 'LastName': 'Karatas', 'Affiliation': 'Department of Anatomy, Faculty of Medicine, İnonu University, Malatya, Turkey.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000829']
1758,32740481,"17β-estradiol/progesterone in a single, oral, softgel capsule (TX-001HR) significantly increased the number of vasomotor symptom-free days in the REPLENISH trial.","OBJECTIVE
To examine responder rates and vasomotor symptom-free days with oral 17β-estradiol/progesterone (E2/P4; TX-001HR) versus placebo in the REPLENISH trial.
METHODS
REPLENISH (NCT01942668) was a phase 3, randomized, double-blind, placebo-controlled, multicenter trial, evaluating single, oral, softgel E2/P4 capsules in postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS). Women with moderate to severe hot flushes (≥7/d or ≥50/wk) were randomized (VMS substudy) to daily E2/P4 (mg/mg) of 1/100, 0.5/100, 0.5/50, 0.25/50, or placebo. Proportions of women with ≥50% or ≥75% reductions in moderate to severe VMS (responders), and those with no severe VMS as well as the weekly number of days without moderate to severe VMS with TX-001HR versus placebo were determined. Mixed model repeated measures was used to analyze data and Fisher exact test was employed to compare E2/P4 versus placebo.
RESULTS
Seven hundred twenty-six women were eligible for the VMS efficacy analysis (E2/P4 1/100 [n = 141], 0.5/100 [n = 149], 0.5/50 [n = 147], 0.25/50 [n = 154], or placebo [n = 135]). Significantly more women treated with all E2/P4 doses versus placebo were ≥50% responders and ≥75% responders at weeks 4 and 12 (P < 0.05) and also had significantly more days per week without moderate to severe VMS at week 12 (1.9-3.0 d for E2/P4 versus 1.3 d for placebo; P < 0.05). The proportion of women without severe hot flushes at week 12 was 43% to 56% for all E2/P4 doses versus 26% for placebo (P ≤ 0.01).
CONCLUSIONS
Women treated with E2/P4 had a greater response to treatment with more VMS-free days than with placebo. The E2/P4 1/100 dose (Bijuva [E2 and P4] capsules) represents an oral treatment option for postmenopausal women with moderate to severe VMS and a uterus.",2020,(P < 0.05) and also had significantly more days per week without moderate to severe VMS at week 12 (1.9-3.0 d for E2/P4 versus 1.3 d for placebo; P < 0.05).,"['n\u200a=\u200a135', 'postmenopausal women (40-65 y) with a uterus and vasomotor symptoms (VMS', 'postmenopausal women with moderate to severe VMS and a uterus', 'Women with moderate to severe hot flushes (≥7/d or ≥50/wk', 'Seven hundred twenty-six women were eligible for the VMS efficacy analysis (E2/P4\u200a1/100 [n\u200a=\u200a141], 0.5/100']","['oral 17β-estradiol/progesterone (E2/P4; TX-001HR', 'TX-001HR versus placebo', '17β-estradiol/progesterone', 'placebo']","['severe VMS', 'moderate to severe VMS', 'proportion of women without severe hot flushes']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}]",726.0,0.691782,(P < 0.05) and also had significantly more days per week without moderate to severe VMS at week 12 (1.9-3.0 d for E2/P4 versus 1.3 d for placebo; P < 0.05).,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bitner', 'Affiliation': 'Spectrum Health, Grand Rapids, MI.'}, {'ForeName': 'Ginger D', 'Initials': 'GD', 'LastName': 'Constantine', 'Affiliation': 'EndoRheum Consultants, LLC, Malvern, PA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001615']
1759,32741496,Dosage of booster phone calls following an SBIRT intervention in the emergency department for reducing substance use.,"Brief Interventions (BIs) for problematic drug use in general medical settings, including in Emergency Departments (EDs), have shown disappointing results compared to those that target problematic alcohol use. Telephone booster calls may augment the impact of a BI delivered in the ED. The current study uses data from the National Drug Abuse Treatment Clinical Trials Network (CTN) Protocol 0047, ""Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments (SMART-ED)"", a multisite randomized clinical trial conducted in six EDs in the U.S. We examine dose effects of telephone boosters (0, 1, or 2 calls completed) with non-treatment seeking patients who we randomized to the BI-Booster condition and who endorsed problematic drug use during their ED visit (N = 427). We assessed primary outcomes at 3-, 6-, and 12-month follow-ups, which included past month use of the primary drug of choice, use of any drug, and heavy drinking. There were no significant differences among those completing 0, 1, or 2 booster calls on any of the three main outcomes at 3-, 6-, and 12-months post-BI in the ED. Patients who were older were significantly more likely to complete booster calls. Taken together, these findings raise questions about the clinical utility of booster phone calls following screening and BIs targeting heterogeneous drug use in the ED.",2020,"There were no significant differences among those completing 0, 1, or 2 booster calls on any of the three main outcomes at 3-, 6-, and 12-months post-BI in the ED.",['patients who we randomized to the BI-Booster condition and who endorsed problematic drug use during their ED visit (N\xa0=\xa0427'],"['telephone boosters (0, 1, or 2 calls completed) with non-treatment seeking', 'SBIRT intervention', 'Brief Interventions (BIs']","['past month use of the primary drug of choice, use of any drug, and heavy drinking']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}]","[{'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",,0.0390799,"There were no significant differences among those completing 0, 1, or 2 booster calls on any of the three main outcomes at 3-, 6-, and 12-months post-BI in the ED.","[{'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Hatch-Maillette', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA 98105, United States of America; Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA 98195, United States of America. Electronic address: hatchm@uw.edu.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA 98105, United States of America; Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA 98195, United States of America.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Laschober', 'Affiliation': 'Alcohol and Drug Abuse Institute, University of Washington, Seattle, WA 98105, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108043']
1760,30698114,Effect of antidepressant switching between nortriptyline and escitalopram after a failed first antidepressant treatment among patients with major depressive disorder.,"BACKGROUND
For patients with major depressive disorder (MDD) experiencing side-effects or non-response to their first antidepressant, little is known regarding the effect of switching between a tricyclic antidepressant (TCA) and a selective serotonin reuptake inhibitor (SSRI).AimsTo compare the switch between the TCA nortriptyline and the SSRI escitalopram.
METHOD
Among 811 adults with MDD treated with nortriptyline or escitalopram for up to 12 weeks, 108 individuals switched from nortriptyline to escitalopram or vice versa because of side-effects or non-response (trial registration: EudraCT No.2004-001723-38 (https://eudract.ema.europa.eu/) and ISRCTN No.03693000 (http://www.controlled-trials.com)). Patients were followed for up to 26 weeks after switching and response was measured with the Montgomery-Åsberg Depression Rating scale (MADRS). We performed adjusted mixed-effects linear regression models with full information maximum likelihood estimation reporting β-coefficients with 95% CIs.
RESULTS
Switching antidepressants resulted in a significant decrease in MADRS scores. This was present for switchers from escitalopram to nortriptyline (n = 36, β = -0.38, 95% CI -0.51 to -0.25, P<0.001) and from nortriptyline to escitalopram (n = 72, β = -0.34, 95% CI -0.41 to -0.26, P<0.001). Both switching options resulted in significant improvement among individuals who switched because of non-response or side-effects. The results were supported by analyses on other rating scales and symptom dimensions.
CONCLUSIONS
These results suggest that switching from a TCA to an SSRI or vice versa after non-response or side-effects to the first antidepressant may be a viable approach to achieve response among patients with MDD.Declarations of interestK.J.A. holds an Alberta Centennial Addiction and Mental Health Research Chair, funded by the Government of Alberta. K.J.A. has been a member of various advisory boards, received consultancy fees and honoraria, and has received research grants from various companies including Johnson and Johnson Pharmaceuticals Research and Development and Bristol-Myers Squibb Pharmaceuticals Limited. D.S. has served on advisory boards for, and received unrestricted grants from, Lundbeck and AstraZeneca. A.F. and P.M. have received honoraria for participating in expert panels for Lundbeck and GlaxoSmithKline.",2019,"β = -0.34, 95% CI -0.41 to -0.26, P<0.001).","['811 adults with MDD treated with', 'patients with major depressive disorder (MDD', 'patients with major depressive disorder']","['nortriptyline or escitalopram', 'nortriptyline and escitalopram', 'nortriptyline']","['MADRS scores', 'rating scales and symptom dimensions', 'Montgomery-Åsberg Depression Rating scale (MADRS']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",811.0,0.0681229,"β = -0.34, 95% CI -0.41 to -0.26, P<0.001).","[{'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Köhler-Forsberg', 'Affiliation': 'Psychosis Research Unit,Aarhus University Hospital - Psychiatry;Department of Clinical Medicine,Aarhus University;and iPSYCH, The Lundbeck Foundation Initiative for Integrative Psychiatric Research,Denmark.'}, {'ForeName': 'Erik Roj', 'Initials': 'ER', 'LastName': 'Larsen', 'Affiliation': 'Chief Physician,Department of Psychiatry,Psychiatry in the Region of Southern Denmark,Institute of Clinical Research,Research Unit of Psychiatry,University of Southern Denmark,Denmark.'}, {'ForeName': 'Henriette N', 'Initials': 'HN', 'LastName': 'Buttenschøn', 'Affiliation': 'Associate Professor,iPSYCH, The Lundbeck Foundation Initiative for Integrative Psychiatric Research;and Translational Neuropsychiatry Unit,Department of Clinical Medicine,Aarhus University,Denmark.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Rietschel', 'Affiliation': 'Professor,Central Institute of Mental Health,Department of Genetic Epidemiology in Psychiatry,Medical Faculty Mannheim/Heidelberg University,Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hauser', 'Affiliation': 'Professor,Laboratory of Psychiatric Genetics,Department of Psychiatry,Poznan University of Medical Sciences,Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Souery', 'Affiliation': 'Professor,Laboratoire de Psychologie Médicale,Université Libre de Bruxelles;Psy Pluriel - Centre Européen de Psychologie Médicale,Belgium.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Maier', 'Affiliation': 'Professor,Department of Psychiatry,University of Bonn,Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Farmer', 'Affiliation': ""Professor,Social, Genetic and Developmental Psychiatry Centre,Institute of Psychiatry, Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McGuffin', 'Affiliation': ""Professor,Social, Genetic and Developmental Psychiatry Centre,Institute of Psychiatry, Psychology and Neuroscience,King's College London,UK.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Aitchison', 'Affiliation': 'Professor,University of Alberta,Canada.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Uher', 'Affiliation': ""Professor,Social, Genetic and Developmental Psychiatry Centre,Institute of Psychiatry,Psychology and Neuroscience,King's College London,UK;and Department of Psychiatry,Dalhousie University,Canada.""}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Mors', 'Affiliation': 'Professor,Psychosis Research Unit,Aarhus University Hospital - Psychiatry;Department of Clinical Medicine,Aarhus University;and iPSYCH, The Lundbeck Foundation Initiative for Integrative Psychiatric Research,Denmark.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2018.302']
1761,32746728,Trunk muscle activity during different types of low weighted squat exercises in normal and forefoot standing conditions.,"Squats are considered a useful basic exercise for trunk muscle activation. To gain knowledge about trunk muscle activity patterns depending on the barbell position in beginners, we examined squats with low weights in the back, front, and overhead position.
METHODS
Twelve healthy adults (6 women/6 men, age: 29.1 (SD 8.0) y, height: 173.4 (6.9) cm, body mass: 70.1 (9.1) kg) randomly performed the three barbell squats in normal and in forefoot standing. Surface electromyography from external (EO) and internal oblique, rectus abdominis, and erector spinae (ES) was recorded. The centre of pressure path length (CoP) and the motion of the lumbar spine were captured.
RESULTS
The overhead squat revealed the highest percent muscle activity, where EO (p = 0.009) and ES (p = 0.03) showed the greatest activity. Forefoot standing did not change overall trunk muscle activities (.05< Hedges' g <.29, 0.17 < p < 0.95) although longer CoP path length (.45 < g < 1.3, p < 0.05) was measured.
CONCLUSIONS
Squat exercises with low weight are useful to activate trunk muscles. Activity increases with the difficulty of the squat by frontal or overhead loading, but not by standing on the forefoot. The low weighted squat can target well core muscle activity in training with beginners or in rehabilitation.",2020,Forefoot standing did not change overall trunk muscle activities (.05,"['Twelve healthy adults (6 women/6 men, age: 29.1 (SD 8.0']","['Squat exercises', 'low weighted squat exercises']","['longer CoP path length', 'Surface electromyography from external (EO) and internal oblique, rectus abdominis, and erector spinae (ES', 'Trunk muscle activity', 'pressure path length (CoP) and the motion of the lumbar spine', 'overall trunk muscle activities']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0224376', 'cui_str': 'Internal Oblique Muscle'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",12.0,0.0204557,Forefoot standing did not change overall trunk muscle activities (.05,"[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Roth', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel , Basel, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Department of Interventions Research in Exercise Training, German Sport University Cologne , Cologne, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Faude', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel , Basel, Switzerland.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Cresswell', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland , Brisbane, Australia.'}]",Journal of sports sciences,['10.1080/02640414.2020.1800358']
1762,32751720,"Effect of a Six-Week Core Conditioning as a Warm-Up Exercise in Physical Education Classes on Physical Fitness, Movement Capability, and Balance in School-Aged Children.","Whether the implementation of feasible, equipment-free, and simple core exercises in warm-up routines in physical education classes for school-aged children is beneficial remains unclear. Therefore, this study investigated the effects of a core conditioning in the warm-up routine of physical education classes on trunk muscular endurance, movement capability, and flexibility in this population. In these pre- and post-test control group experiments, 52 healthy, school-aged children (aged 10-11 years) were cluster randomized allocated to either the dynamic core exercise (DCE) group or general physical education (GPE) group. The DCE group performed a 10-min core exercise routine twice per week for six consecutive weeks; the GPE group performed traditional physical education warm-up exercises regularly. The children were assessed by conducting the trunk muscular endurance test (i.e., dynamic curl-up, static curl-up, plank, and lateral plank), functional movement screen (FMS), and single-leg balance test before and after the intervention. At the end of the intervention, the DCE group demonstrated a significant effect on trunk muscular endurance, movement capability (i.e., FMS scores), flexibility, and balance (each p < 0.001, effect size: 0.38-1.3). Furthermore, the DCE group showed significant improvements in all outcome measurements compared with the GPE group ( p < 0.05, effect size: 0.29-1.68). These data may provide a reference for incorporating additional core stability exercises in the warm-up routine of physical education classes in school-aged children in the future.",2020,"Furthermore, the DCE group showed significant improvements in all outcome measurements compared with the GPE group ( p < 0.05, effect size: 0.29-1.68).","['School-Aged Children', 'school-aged children', '52 healthy, school-aged children (aged 10-11 years']","['dynamic core exercise (DCE) group or general physical education (GPE', 'GPE group performed traditional physical education warm-up exercises regularly', 'DCE', 'GPE']","['trunk muscular endurance, movement capability, and flexibility', 'Physical Fitness, Movement Capability, and Balance', 'trunk muscular endurance, movement capability (i.e., FMS scores), flexibility, and balance']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",52.0,0.036687,"Furthermore, the DCE group showed significant improvements in all outcome measurements compared with the GPE group ( p < 0.05, effect size: 0.29-1.68).","[{'ForeName': 'Nai-Jen', 'Initials': 'NJ', 'LastName': 'Chang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'I-Hsien', 'Initials': 'IH', 'LastName': 'Tsai', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Chia-Lun', 'Initials': 'CL', 'LastName': 'Lee', 'Affiliation': 'Center for Physical and Health Education, National Sun Yat-sen University, Kaohsiung 804, Taiwan.'}, {'ForeName': 'Chun-Hao', 'Initials': 'CH', 'LastName': 'Liang', 'Affiliation': 'Department of Sports Medicine, Kaohsiung Medical University, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17155517']
1763,32762701,"High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial.","BACKGROUND
High-flow nasal cannula (HFNC) oxygen therapy is being increasingly used to prevent post-extubation hypoxemic respiratory failure and reintubation. However, evidence to support the use of HFNC in chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation is limited. This study was conducted to test if HFNC is non-inferior to non-invasive ventilation (NIV) in preventing post-extubation treatment failure in COPD patients previously intubated for hypercapnic respiratory failure.
METHODS
COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals. The primary endpoint was treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV for patients in the NFNC group or vice versa).
RESULTS
Ninety-six patients were randomly assigned to the HFNC group or NIV group. After secondary exclusion, 44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis. The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%. Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group, with a risk difference of - 50.0% (95% CI, - 74.6 to - 12.9%, p = 0.015). One hour after extubation, the mean respiratory rates of both groups were faster than their baseline levels before extubation (p < 0.050). Twenty-four hours after extubation, the respiratory rate of the HFNC group had returned to baseline, but the NIV group was still higher than the baseline. Forty-eight hours after extubation, the respiratory rates of both groups were not significantly different from the baseline. The average number of daily airway care interventions in the NIV group was 7 (5-9.3), which was significantly higher than 6 (4-7) times in the HFNC group (p = 0.006). The comfort score and incidence of nasal and facial skin breakdown of the HFNC group was also significantly better than that of the NIV group [7 (6-8) vs 5 (4-7), P < 0.001] and [0 vs 9.6%, p = 0.027], respectively.
CONCLUSION
Among COPD patients with severe hypercapnic respiratory failure who received invasive ventilation, the use of HFNC after extubation did not result in increased rates of treatment failure compared with NIV. HFNC also had better tolerance and comfort than NIV.
TRIAL REGISTRATION
chictr.org ( ChiCTR1800018530 ). Registered on 22 September 2018, http://www.chictr.org.cn/usercenter.aspx.",2020,"The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%.","['COPD patients previously intubated for hypercapnic respiratory failure', 'COPD patients with severe hypercapnic respiratory failure who received', 'Ninety-six patients', '44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis', 'chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation', 'COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals', 'chronic obstructive pulmonary disease patients after extubation']","['High-flow nasal cannula ', 'invasive ventilation', 'HFNC) oxygen therapy', 'HFNC', 'High-flow nasal cannula oxygen therapy versus non-invasive ventilation']","['rates of treatment failure', 'treatment failure rate', 'respiratory rates', 'treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV', 'mean respiratory rates', 'comfort score and incidence of nasal and facial skin breakdown', 'respiratory rate', 'average number of daily airway care interventions']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",96.0,0.196719,"The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%.","[{'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Joseph Harold', 'Initials': 'JH', 'LastName': 'Walline', 'Affiliation': 'Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Bingyu', 'Initials': 'B', 'LastName': 'Ling', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Jiayan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Pharmacy Department, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China. 32494845@qq.com.""}, {'ForeName': 'Bingxia', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Shan', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Qingcheng', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Geng', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Emergency Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. xujunfree@126.com.'}]","Critical care (London, England)",['10.1186/s13054-020-03214-9']
1764,32769526,The Effect of Conditioned Media From Human Adipocyte-Derived Mesenchymal Stem Cells on Androgenetic Alopecia After Nonablative Fractional Laser Treatment.,"BACKGROUND
The conditioned media from adipocyte-derived mesenchymal stem cells-conditioned media (ADSC-CM) contains cytokines and growth factors that stimulate hair regeneration.
OBJECTIVE
We evaluated the efficacy and safety of human ADSC-CM treatment on patients who underwent nonablative fractional laser for the treatment of androgenetic alopecia (AGA).
MATERIALS AND METHODS
Thirty patients who underwent nonablative fractional laser treatment were topically administered either ADSC-CM or placebo solution. As a primary outcome, phototrichograms were taken to measure changes in hair density at each visit. In addition, global improvement scores (GISs) were compared by clinical digital photographs, which were taken at the initial and final visits, and assessed by 2 independent dermatologists. Finally, the investigator's improvement score was measured by questionnaire response during the final visit.
RESULTS
Hair density comparisons during the treatment period revealed that the ADSC-CM group had significantly higher final densities compared with the placebo group. The GIS of the ADSC-CM group was also significantly higher than the placebo group. Finally, no adverse effects associated with the application of ADSC-CM were noted during the study.
CONCLUSION
The application of ADSC-CM after nonablative fractional laser treatment accelerated increases in hair density and volume in AGA patients.",2020,The application of ADSC-CM after nonablative fractional laser treatment accelerated increases in hair density and volume in AGA patients.,"['AGA patients', 'Thirty patients who underwent', 'patients who underwent nonablative fractional laser for the treatment of androgenetic alopecia (AGA']","['ADSC-CM or placebo solution', 'Conditioned Media From Human Adipocyte-Derived Mesenchymal Stem Cells', 'human ADSC-CM treatment', 'nonablative fractional laser treatment', 'Nonablative Fractional Laser Treatment', 'placebo']","['Androgenetic Alopecia', 'hair density and volume', 'efficacy and safety', 'Hair density comparisons', 'questionnaire response', 'hair density', 'global improvement scores (GISs']","[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0162518', 'cui_str': 'Conditioned Culture Medium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0523452,The application of ADSC-CM after nonablative fractional laser treatment accelerated increases in hair density and volume in AGA patients.,"[{'ForeName': 'Young In', 'Initials': 'YI', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jihee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jemin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Ju Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002518']
1765,32773651,Effect of vitamin D supplementation during pregnancy on mid-to-late gestational blood pressure in a randomized controlled trial in Bangladesh.,"OBJECTIVE
To examine the dose-dependent effect of maternal vitamin D during pregnancy on blood pressure from mid-to-late gestation within the context of a randomized, placebo-controlled trial of vitamin D supplementation in Bangladesh (n = 1298).
METHODS
Healthy women without hypertension were enrolled at 17-24 weeks gestation and randomized to one of four vitamin D doses during pregnancy: placebo, 4200, 16 800 or 28 000 IU/week. This substudy examined 1257 women with blood pressure measured at enrollment with at least one other timepoint (measurements included at 24 weeks, 30 weeks, and weekly from 36 weeks until delivery). Effects of vitamin D on SBP or DBP were analyzed using mixed-effects models.
RESULTS
Vitamin D did not have an effect on SBP or DBP at 24 or 30 weeks; blood pressure was higher at 36 weeks for the highest dose versus placebo [mean difference (95% CI) mmHg: SBP = 2.3 (0.9-3.7); DBP = 1.9 (0.7-3.0)]. The differences in changes in SBP and DBP between vitamin D groups and placebo across intervals were small (P > 0.10), but the difference for 28 000 IU/week versus placebo was the highest from 30 to 36 weeks [SBP 0.2 (-0.1 to 0.5) and DBP 0.2 (-0.0 to 0.4) mmHg].
CONCLUSION
Vitamin D supplementation starting mid-pregnancy did not affect SBP or DBP until late gestation, and then only at the highest dose. These results do not support the clinical use of vitamin D in pregnancy to lower maternal blood pressure.",2021,"RESULTS
Vitamin D did not have an effect on SBP or DBP at 24 or 30 weeks; blood pressure was higher at 36 weeks for the highest dose versus placebo [mean difference (95% CI)","['Bangladesh (n\u200a=\u200a1298', 'mmHg', 'Healthy women without hypertension were enrolled at 17-24 weeks gestation', '1257 women with blood pressure measured at enrollment with at least one other timepoint (measurements included at 24, 30 weeks, and weekly from 36 weeks until delivery', 'pregnancy on mid-to-late gestational blood pressure in a randomized controlled trial in Bangladesh']","['maternal vitamin D', 'Vitamin D supplementation', 'vitamin D doses during pregnancy: placebo', 'vitamin D', 'vitamin D supplementation', 'placebo']","['blood pressure', 'SBP and DBP', 'maternal blood pressure', 'SBP or DBP']","[{'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",1257.0,0.522405,"RESULTS
Vitamin D did not have an effect on SBP or DBP at 24 or 30 weeks; blood pressure was higher at 36 weeks for the highest dose versus placebo [mean difference (95% CI)","[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Subramanian', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Korsiak', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children.'}, {'ForeName': 'Kellie E', 'Initials': 'KE', 'LastName': 'Murphy', 'Affiliation': 'Department of Obstetrics and Gynecology, Mt. Sinai Hospital, Toronto, Canada.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Al Mahmud', 'Affiliation': 'Nutrition and Clinical Services Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Roth', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children.'}, {'ForeName': 'Alison D', 'Initials': 'AD', 'LastName': 'Gernand', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, Pennsylvania, USA.'}]",Journal of hypertension,['10.1097/HJH.0000000000002609']
1766,32783051,Left atrial structure and function among different subtypes of atrial fibrillation: an echocardiographic substudy of the AMIO-CAT trial.,"AIMS
Little is known about cardiac structure and function among atrial fibrillation (AF) subtypes; paroxysmal AF vs. persistent AF (PxAF), and across AF burden. We sought to assess differences in left atrial (LA) measures by AF subtype and burden.
METHODS AND RESULTS
This was a cross-sectional echocardiographic substudy of a randomized trial of AF patients scheduled for catheter ablation. Patients had an echocardiogram performed 0-90 days prior to study inclusion. We performed conventional echocardiographic measures, left ventricular (LV) and LA speckle tracking. Measures were compared between AF subtype and burden (0%, 0-99%, and 99-100%) determined by 72-h Holter monitoring. Of 212 patients, 107 had paroxysmal AF and 105 had PxAF. Those with PxAF had significantly reduced systolic function (LV ejection fraction: 48% vs. 53%; P < 0.001), larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction (LAEF: 29% vs. 36%, P < 0.001), and reduced LA strain (LAs) (LAs: 20% vs. 26%, P < 0.001). LA measures remained significantly lower in PxAF after multivariable adjustments. All LA measures and measures of systolic function were significantly impaired in patients with 99-100% AF burden, whereas all measures were similar between the other groups (LAVi: 40mL/m2 vs. 33mL/m2 vs. 34mL/m2; LAEDVi: 31mL/m2 vs. 21mL/m2 vs. 22mL/m2, LA emptying fraction: 23% vs. 35% vs. 36%, LAs: 16% vs. 25% vs. 25%, for 99-100%, 0-99%, and 0% AF, respectively, P < 0.001 for all). These differences were consistent after multivariable adjustments.
CONCLUSION
LA mechanics differ between AF subtype and burden and these characteristics influence the clinical interpretation of these measures.",2020,"Those with PxAF had significantly reduced systolic function (LV ejection fraction: 48% vs. 53%; P < 0.001), larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction (LAEF: 29% vs. 36%, P < 0.001), and reduced LA strain (LAs) (LAs: 20% vs. 26%, P < 0.001).","['Of 212 patients, 107 had paroxysmal AF and 105 had PxAF']","['conventional echocardiographic measures, left ventricular (LV) and LA speckle tracking', 'AF patients scheduled for catheter ablation']","['reduced LA strain (LAs', 'LA measures', 'larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction', 'All LA measures and measures of systolic function', 'left atrial (LA) measures by AF subtype and burden', 'systolic function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}]",212.0,0.101298,"Those with PxAF had significantly reduced systolic function (LV ejection fraction: 48% vs. 53%; P < 0.001), larger end-systolic and end-diastolic LA volumes (LAVi and LAEDVi), reduced LA emptying fraction (LAEF: 29% vs. 36%, P < 0.001), and reduced LA strain (LAs) (LAs: 20% vs. 26%, P < 0.001).","[{'ForeName': 'Flemming Javier', 'Initials': 'FJ', 'LastName': 'Olsen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Darkner', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Johannessen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Gislason', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Biering-Sørensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Gentofte Hospitalsvej 1, 2900 Hellerup, Denmark.'}]",European heart journal cardiovascular Imaging,['10.1093/ehjci/jeaa222']
1767,32789987,"The impact of in-person and video-recorded animal experiences on zoo visitors' cognition, affect, empathic concern, and conservation intent.","Currently there are mixed results regarding the ability for media or more specifically video to increase a person's interest in conservation. However, there is a growing amount of evidence that in-person experiences at a zoo or aquarium can increase a person's interest in conservation. The goal of the current study was to examine the difference between an in-person experience viewing a polar bear training session and watching a video of the same experience on cognition, emotion, empathic concern, and conservation intent. A total of 124 Brookfield Zoo members were randomly assigned to one of three conditions. Condition 1 was an in-person 10 min (Live Animal) experience viewing a training session with a polar bear. Condition 2 participants (Video Animal) watched a video of the same experience from Condition 1 and Condition 3 (Control) listened to the audio from Condition 1 but only viewed an image of one of our animal care specialists. Results suggest that the live condition is associated with higher probability of answering questions correctly, having a positive emotional experience, having greater empathic concern for wild bears, and wanting to get involved in conservation when compared to the control. These impacts were not observed for the video condition suggesting that for this study, watching a video of a training session was not an effective tool for getting people involved in conservation. Future research is needed to better understand this important topic, but we now have further evidence of the importance of in-person zoo experiences.",2020,"Results suggest that the live condition is associated with higher probability of answering questions correctly, having a positive emotional experience, having greater empathic concern for wild bears, and wanting to get involved in conservation when compared to the control.",['A total of 124 Brookfield Zoo members'],['Condition 2 participants (Video Animal) watched a video of the same experience from Condition 1 and Condition 3 (Control) listened to the audio from Condition 1 but only viewed an image of one of our animal care specialists'],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",[],124.0,0.0589736,"Results suggest that the live condition is associated with higher probability of answering questions correctly, having a positive emotional experience, having greater empathic concern for wild bears, and wanting to get involved in conservation when compared to the control.","[{'ForeName': 'Lance J', 'Initials': 'LJ', 'LastName': 'Miller', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Jerry F', 'Initials': 'JF', 'LastName': 'Luebke', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Matiasek', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Granger', 'Affiliation': 'University of California, Irvine, California.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Razal', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Heather J B', 'Initials': 'HJB', 'LastName': 'Brooks', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maas', 'Affiliation': 'Chicago Zoological Society-Brookfield Zoo, Brookfield, Illinois.'}]",Zoo biology,['10.1002/zoo.21565']
1768,32800712,Radiation Dose Reduction in Early-Stage Hodgkin Lymphoma.,"INTRODUCTION
Treatment for early-stage Hodgkin lymphoma (HL) involves radiotherapy (RT), chemotherapy, or combined modality therapy (CMT). We analyzed reduction of RT dose in CMT, particularly in the context of German Hodgkin Study Group (GHSG) HD10 randomized trial results of 2010.
PATIENTS AND METHODS
The National Cancer Data Base was queried for patients with stage I-II HL receiving CMT. RT dose and associated characteristics were analyzed. Stage I and absence of B symptoms were used as a surrogate for early-stage favorable disease.
RESULTS
Of 31,301 patients with stage I-II HL, 11,457 received CMT between 2004 and 2015. Using the surrogate defined above, 1955 patients (17.1%) were classified as having favorable disease. The majority (61.6%) received 30-36 Gy, while 7.0% received 20 Gy. The provision of 20 Gy was more common in stage I patients (12.3% vs. 5.4% in stage II) and at academic facilities (10.8% vs. 6.3%-8.9% at other facilities). Use of 20 Gy (vs. 30-36 Gy) was less likely with thorax site (odds ratio [OR] 0.43 vs. head and neck), stage II disease (OR 0.41), and B symptoms (OR 0.33). Notably, the use of 20 Gy increased dramatically after 2010 (the year of publication of GHSG HD10 trial results), with rates of 12.3% in 2010-2015 versus 0.1% in 2004-2009 (OR 6.3, P < .001). This was even more pronounced in cases of favorable early-stage disease, with 25.5% after 2010 versus 2.8% before 2010 (OR 13.2, P < .001). The use of doses > 36 Gy decreased over a corresponding time period (OR 0.44, P < .001).
CONCLUSION
Analysis of CMT for patients with early-stage HL demonstrates variability in RT dose, including increasing use of 20 Gy and decreasing use of high doses > 36 Gy.",2020,"The use of doses > 36 Gy decreased over a corresponding time period (OR 0.44, P < .001).
","['31,301 patients with stage I-II HL', 'Early-Stage Hodgkin Lymphoma']","['radiotherapy (RT), chemotherapy, or combined modality therapy (CMT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]",[],31301.0,0.0726155,"The use of doses > 36 Gy decreased over a corresponding time period (OR 0.44, P < .001).
","[{'ForeName': 'Bhartesh A', 'Initials': 'BA', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Cheongeun', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Department of Population Health: Biostatistics, NYU Langone Health, New York, NY.'}, {'ForeName': 'S Peter', 'Initials': 'SP', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Jerome M', 'Initials': 'JM', 'LastName': 'Karp', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grossbard', 'Affiliation': 'Department of Medical Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Naamit K', 'Initials': 'NK', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY. Electronic address: Naamit.Gerber@nyulangone.org.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.07.010']
1769,32744862,"Effects of Interleukin-1β Inhibition on Incident Hip and Knee Replacement : Exploratory Analyses From a Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND
Osteoarthritis is a common inflammatory disorder with no disease-modifying therapies. Whether inhibition of interleukin-1β (IL-1β) can reduce the consequences of large joint osteoarthritis is unclear.
OBJECTIVE
To determine whether IL-1β inhibition with canakinumab reduces incident total hip or knee replacement (THR/TKR).
DESIGN
Exploratory analysis of a randomized trial. (ClinicalTrials.gov: NCT01327846).
SETTING
1091 clinical sites in 39 countries.
PARTICIPANTS
10 061 CANTOS (Canakinumab Anti-inflammatory Thrombosis Outcomes Study) participants.
INTERVENTION
Random allocation to placebo or canakinumab (50, 150, or 300 mg) subcutaneously once every 3 months.
MEASUREMENTS
The primary and secondary outcomes were time to first incident THR/TKR and time to first occurrence of an osteoarthritis-related adverse event (AE). Data were obtained through blinded ascertainment of trial clinical and safety databases.
RESULTS
Median follow-up was 3.7 years. For the individual canakinumab dose groups, compared with placebo, hazard ratios (HRs) for incident THR/TKR during follow-up were 0.60 (95% CI, 0.38 to 0.95) for the 50-mg group, 0.53 (CI, 0.33 to 0.84) for the 150-mg group, and 0.60 (CI, 0.38 to 0.93) for the 300-mg group. Thus, in the pooled canakinumab groups, compared with the placebo group, incidence rates for THR/TKR were 0.31 and 0.54 events per 100 person-years (HR, 0.58 [CI, 0.42 to 0.80]; P = 0.001), respectively. The HR for the secondary end point of osteoarthritis-related AEs was 0.73 (CI, 0.61 to 0.87). Similar findings were observed in analyses restricted to participants with a history of osteoarthritis.
LIMITATION
Because the parent trial was not designed to examine the efficacy of IL-1β inhibitors in osteoarthritis, information on structural joint outcomes was not collected.
CONCLUSION
Findings from this exploratory analysis of a randomized controlled trial support further investigation of IL-1β inhibition for treatment of large joint osteoarthritis.
PRIMARY FUNDING SOURCE
Novartis Pharmaceuticals.",2020,"Whether inhibition of interleukin-1β (IL-1β) can reduce the consequences of large joint osteoarthritis is unclear.
","['10\xa0061', '1091 clinical sites in 39 countries', 'Incident Hip and Knee Replacement']","['interleukin-1β (IL-1β', 'canakinumab', 'Placebo', 'placebo or canakinumab', 'placebo', 'Interleukin-1β Inhibition']","['hazard ratios (HRs) for incident THR/TKR', 'incidence rates for THR/TKR', 'structural joint outcomes', 'time to first incident THR/TKR and time to first occurrence of an osteoarthritis-related adverse event (AE']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040005', 'cui_str': 'Threonine'}, {'cui': 'C0206364', 'cui_str': 'Receptor Protein-Tyrosine Kinase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.513316,"Whether inhibition of interleukin-1β (IL-1β) can reduce the consequences of large joint osteoarthritis is unclear.
","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schieker', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland, and Ludwig Maximilian University of Munich, Munich, Germany (M.S.).'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and National Institute for Health Research Leeds BiomedicalResearch Centre, Leeds, United Kingdom (P.G.C.).'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mindeholm', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Praestgaard', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., P.M.R.).""}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Scotti', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Gram', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Thuren', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland (T.T.).'}, {'ForeName': 'Ronenn', 'Initials': 'R', 'LastName': 'Roubenoff', 'Affiliation': 'Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, and Basel, Switzerland (L.M., J.P., C.S., H.G., R.R.).'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., P.M.R.).""}]",Annals of internal medicine,['10.7326/M20-0527']
1770,32745768,Oxylipin regulation by phenolic compounds from coffee beverage: Positive outcomes from a randomized controlled trial in healthy adults and macrophage derived foam cells.,"Oxylipins are considered biomarkers related to cardiovascular diseases (CVDs). They are generated in vivo via the oxygenation of polyunsaturated fatty acids as a result of oxidative stress and inflammation. Oxylipins are involved in vascular functions and are produced during foam cell formation in atherogenesis. Additionally, the consumption coffee is associated with the regulation on a particular oxylipin group, the F 2t -isoprostanes (F 2t -IsoPs). This function has been attributed to the chlorogenic acids (CGAs) from the coffee beverage. Considering the anti-inflammatory and antioxidant properties of CGAs, we evaluated the effects of two types of coffee that provided 787 mg CGAs/day (Coffee A) and 407 mg CGAs/day (Coffee B) by reducing 35 selected oxylipins in healthy subjects. Furthermore, we assessed the effect of CGAs on the cellular proatherogenic response in foam cells by using an oxidized LDL (oxLDL)-macrophage interaction model. After eight weeks of coffee consumption, the contents of 12 urine oxylipins were reduced. However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs. Neither of the two coffees reduced the levels of oxLDL. Moreover, the in vitro oxylipin induction by oxLDL on foam cells was ameliorated by phenolic acids and CGAs, including the inhibition of IsoPs and PGs by caffeoylquinic and dicaffeoylquinic acids, respectively, while the phenolic acids maintained both antioxidant and anti-inflammatory activities. These findings suggest that coffee antioxidants are strong regulators of oxylipins related to CVDs. The clinical trial was registered on the International Clinical Trials Registry Platform, WHO primary registry (RPCEC00000168).",2020,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","['healthy adults and macrophage derived foam cells', 'healthy subjects']",['CGAs'],"['levels of oxLDL', 'IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0016390', 'cui_str': 'Foam cell'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0055633', 'cui_str': 'Chromogranin A'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0997851', 'cui_str': 'Geodia'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0588372,"However, the effect of Coffee A showed a stronger decrease in IsoPs, dihomo-IsoPs, prostaglandins (PGs) and PG metabolites, probably due to its higher content of CGAs.","[{'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Lara-Guzmán', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Medina', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Álvarez', 'Affiliation': 'Grupo de Investigación en Sustancias Bioactivas, Facultad de Ciencias Farmacéuticas y Alimentarias, Universidad de Antioquia, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Oger', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Durand', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Galano', 'Affiliation': 'Institut des Biomolécules Max Mousseron (IBMM), UMR 5247, CNRS, University of Montpellier, ENSCM, Faculty of Pharmacy, Montpellier, France.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Zuluaga', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil-Izquierdo', 'Affiliation': 'Research Group on Quality, Safety and Bioactivity of Plant Foods, Department of Food Science and Technology, CEBAS (CSIC), P.O. Box 164, 30100 Campus University Espinardo, Murcia, Spain. Electronic address: angelgil@cebas.csic.es.'}, {'ForeName': 'Katalina', 'Initials': 'K', 'LastName': 'Muñoz-Durango', 'Affiliation': 'Vidarium - Nutrition, Health and Wellness Research Center, Nutresa Business Group, Calle 8 Sur No. 50-67, Medellín, Colombia. Electronic address: kmunoz@serviciosnutresa.com.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.07.020']
1771,32758677,Inspiratory neural drive and dyspnea in interstitial lung disease: Effect of inhaled fentanyl.,"BACKGROUND
Exertional dyspnea in interstitial lung disease (ILD) remains difficult to manage despite advances in disease-targeted therapies. Pulmonary opioid receptors present a potential therapeutic target for nebulized fentanyl to provide dyspnea relief.
METHODS
ILD patients were characterized with reference to healthy volunteers. A randomized, double-blind, placebo-controlled crossover comparison of 100 mcg nebulized fentanyl vs placebo on dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise was performed in 21 ILD patients.
RESULTS
Dyspnea intensity in ILD increased in association with an increase in IND (diaphragm activation) from a high resting value of 16.66 ± 6.52 %-60.04 ± 12.52 % of maximum (r = 0.798, p < 0.001). At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
CONCLUSION
IND rose sharply during constant work rate exercise in association with dyspnea intensity in mild to moderate ILD but was not different after nebulized fentanyl compared with placebo.",2020,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","['ILD patients were characterized with reference to healthy volunteers', 'interstitial lung disease', '21 ILD patients']","['inhaled fentanyl', '100 mcg nebulized fentanyl vs placebo', 'nebulized fentanyl', 'fentanyl vs placebo', 'placebo']","['IND responses', 'IND (diaphragm activation', 'dyspnea intensity and inspiratory neural drive (IND) during constant work rate (CWR) cycle exercise', 'dyspnea intensity ratings', 'Inspiratory neural drive and dyspnea']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",21.0,0.334941,"At isotime during CWR exercise, Borg dyspnea intensity ratings with fentanyl vs placebo were 4.1 ± 1.2 vs 3.8 ± 1.2, respectively (p = 0.174), and IND responses were also similar.
","[{'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada; Clinician Investigator Program, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Ibrahim-Masthan', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Moran-Mendoza', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Neder', 'Initials': 'N', 'LastName': 'Ja', 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston Health Sciences Centre, Kingston, Ontario, Canada. Electronic address: odonnell@queensu.ca.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103511']
1772,32767824,"Transcutaneous vagus nerve stimulation prevents the development of, and reverses, established oesophageal pain hypersensitivity.","BACKGROUND
The vagus nerve exerts an anti-nociceptive effect on the viscera.
AIM
To investigate whether transcutaneous vagal nerve stimulation (t-VNS) prevents the development of and/or reverses established visceral hypersensitivity in a validated model of acid-induced oesophageal pain.
METHODS
Before and after a 30-minute infusion of 0.15M hydrochloric acid into the distal oesophagus, pain thresholds to electrical stimulation were determined in the proximal non-acid exposed oesophagus. Validated sympathetic (cardiac sympathetic index) and parasympathetic (cardiac vagal tone [CVT]) nervous system measures were recorded. In study 1, 15 healthy participants were randomised in a blinded crossover design to receive either t-VNS or sham for 30 minutes during acid infusion. In study 2, 18 different healthy participants were randomised in a blinded crossover design to receive either t-VNS or sham, for 30 minutes after acid infusion.
RESULTS
Study 1: t-VNS increased CVT (31.6% ± 58.7 vs -9.6 ± 20.6, P = 0.02) in comparison to sham with no effect on cardiac sympathetic index. The development of acid-induced oesophageal hypersensitivity was prevented with t-VNS in comparison to sham (15.5 mA per unit time (95% CI 4.9 - 26.2), P = 0.004). Study 2: t-VNS increased CVT (26.3% ± 32.7 vs 3 ± 27.1, P = 0.03) in comparison to sham with no effect on cardiac sympathetic index. t-VNS reversed established acid-induced oesophageal hypersensitivity in comparison to sham (17.3mA/unit time (95% CI 9.8-24.7), P = 0.0001).
CONCLUSIONS
t-VNS prevents the development of, and reverses established, acid-induced oesophageal hypersensitivity. These results have therapeutic implications for the management of visceral pain hypersensitivity.",2020,"The development of acid-induced oesophageal hypersensitivity was prevented with t-VNS in comparison to sham (15.5 mA per unit time (95% CI 4.9 - 26.2), P = 0.004).","['15 healthy participants', '18 different healthy participants']","['transcutaneous vagal nerve stimulation (t-VNS', '0.15M hydrochloric acid into the distal oesophagus', 'Transcutaneous vagus nerve stimulation', 't-VNS or sham for 30\xa0minutes during acid infusion', 't-VNS']","['CVT', 'cardiac sympathetic index', 'oesophageal hypersensitivity', 'development of acid-induced oesophageal hypersensitivity', 'Validated sympathetic (cardiac sympathetic index) and parasympathetic (cardiac vagal tone [CVT]) nervous system measures', 'pain thresholds to electrical stimulation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0240912', 'cui_str': 'Congenital vertical talus'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0027763', 'cui_str': 'Structure of nervous system'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]",15.0,0.214132,"The development of acid-induced oesophageal hypersensitivity was prevented with t-VNS in comparison to sham (15.5 mA per unit time (95% CI 4.9 - 26.2), P = 0.004).","[{'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Farmer', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Albusoda', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}, {'ForeName': 'Gehanjali', 'Initials': 'G', 'LastName': 'Amarasinghe', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Ruffle', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}, {'ForeName': 'Heather E', 'Initials': 'HE', 'LastName': 'Fitzke', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}, {'ForeName': 'Ruqaya', 'Initials': 'R', 'LastName': 'Idrees', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Brock', 'Affiliation': 'Mech-Sense, Department of Gastroenterology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Qasim', 'Initials': 'Q', 'LastName': 'Aziz', 'Affiliation': 'Centre for Neuroscience, Surgery and Trauma, Blizard Institute, Wingate Institute of Neurogastroenterology, Barts and the London School of Medicine & Dentistry, Mary University of London, London, UK.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15869']
1773,32763026,"Asthma control affects school absence, achievement and quality of school life: a multicenter study.","INTRODUCTION AND OBJECTIVES
Asthma may have a detrimental effect on school attendance and achievement. Friend relations, attendance to school activities, quality of life (QOL) of asthmatic children may be negatively affected. The aim of this study was to evaluate factors influencing school functioning for asthmatic school-age children.
MATERIALS AND METHODS
From January to May 2019, parents and school-age children who were followed by a diagnosis of asthma for more than one year, from seven pediatric allergy centers, were given a standard questionnaire including questions about child's disease, school performance, absenteeism, home-family-school conditions. A pediatric QOL questionnaire was filled out by children. For evaluating control in the previous year, children who had more than two exacerbations and/or had any exacerbations needing systemic corticosteroids in the previous year were defined as inadequate control. School absence over nine days was taken into account as this has been shown to bring a risk for successful school life.
RESULTS
507 patients were included. Asthma control status was found to be effective on school absence (p < 0.001), on school success (especially math scores) (p < 0.001), on friend relations (p = 0.033), QOL (p < 0.001), attendance to school activities (p < 0.001). Regular follow-up (p < 0.001), regular use of asthma medication (p = 0.014), tobacco smoke exposure (p < 0.001), heating with stove at home (p = 0.01) affected asthma control. School conditions such as crowdedness (p = 0.044), humidity of the class (p = 0.025), knowledge of teacher about child's asthma (p = 0.012) were effective on asthma control independent of home conditions and asthma treatment parameters.
CONCLUSION
School interventions are important to improve asthma management.",2020,"Asthma control status was found to be effective on school absence (p < 0.001), on school success (especially math scores) (p < 0.001), on friend relations (p = 0.033), QOL (p < 0.001), attendance to school activities (p < 0.001).","['asthmatic school-age children', '507 patients were included', 'children who had more than two exacerbations and/or had any exacerbations needing systemic corticosteroids in the previous year', ""From January to May 2019, parents and school-age children who were followed by a diagnosis of asthma for more than one year, from seven pediatric allergy centers, were given a standard questionnaire including questions about child's disease, school performance, absenteeism, home-family-school conditions""]",[],"['attendance to school activities', 'school absence, achievement and quality of school life', 'QOL', 'school success', ""knowledge of teacher about child's asthma"", 'humidity of the class', 'regular use of asthma medication', 'tobacco smoke exposure', 'school absence', 'school functioning', 'Friend relations, attendance to school activities, quality of life (QOL']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0020167', 'cui_str': 'Humidity'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",507.0,0.0250252,"Asthma control status was found to be effective on school absence (p < 0.001), on school success (especially math scores) (p < 0.001), on friend relations (p = 0.033), QOL (p < 0.001), attendance to school activities (p < 0.001).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Toyran', 'Affiliation': 'Ankara City Hospital, Division of Pediatric Allergy and Immunology, Ankara, Turkey. Electronic address: mugetoyran@yahoo.com.'}, {'ForeName': 'I T', 'Initials': 'IT', 'LastName': 'Yagmur', 'Affiliation': 'Ankara City Hospital, Division of Pediatric Allergy and Immunology, Ankara, Turkey. Electronic address: iremtrgy@gmail.com.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Guvenir', 'Affiliation': 'Malatya Training and Research Hospital, Pediatric Allergy and Immunology Clinic, Malatya, Turkey. Electronic address: dr.hguvenir@gmail.com.'}, {'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Haci', 'Affiliation': 'Health Sciences University, Dr.Behçet Uz Children Training and Research Hospital, Division of Pediatric Allergy and Immunology, İzmir, Turkey. Electronic address: dridilakayhaci@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bahceci', 'Affiliation': 'Cigli Training and Research Hospital, Division of Pediatric Allergy and Immunology, İzmir, Turkey. Electronic address: semihabahceci@hotmail.com.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Batmaz', 'Affiliation': 'Tokat State Hospital, Pediatric Allergy and Clinical Immunology Clinic, Tokat, Turkey. Electronic address: drsehra@yahoo.com.'}, {'ForeName': 'O Y', 'Initials': 'OY', 'LastName': 'Topal', 'Affiliation': 'Ankara City Hospital, Division of Pediatric Allergy and Immunology, Ankara, Turkey. Electronic address: ozgeyilmaztopal@gmail.com.'}, {'ForeName': 'I K', 'Initials': 'IK', 'LastName': 'Celik', 'Affiliation': 'Ankara City Hospital, Division of Pediatric Allergy and Immunology, Ankara, Turkey. Electronic address: dr.ilknur-46@windowslive.com.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Karaatmaca', 'Affiliation': 'Ankara City Hospital, Division of Pediatric Allergy and Immunology, Ankara, Turkey. Electronic address: drbkatmaca@gmail.com.'}, {'ForeName': 'E D', 'Initials': 'ED', 'LastName': 'Misirlioglu', 'Affiliation': 'Ankara City Hospital, Division of Pediatric Allergy and Immunology, Ankara, Turkey. Electronic address: edibekm@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Civelek', 'Affiliation': 'Ankara City Hospital, Division of Pediatric Allergy and Immunology, Ankara, Turkey. Electronic address: ersoycivelek@gmail.com.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Can', 'Affiliation': 'Balıkesir University School of Medicine, Department of Pediatrics, Balıkesir, Turkey. Electronic address: ddcan15@hotmail.com.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Kocabas', 'Affiliation': 'Muğla Sitki Kocman University School of Medicine, Department of Pediatrics, Mugla, Turkey. Electronic address: cankocabas@yahoo.com.'}]",Allergologia et immunopathologia,['10.1016/j.aller.2020.05.005']
1774,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND
Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS
We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS
A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS
Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS
Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS
Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
1775,32770640,Secukinumab improves signs and symptoms of non-radiographic axial spondyloarthritis: primary results of a randomized controlled phase III study.,"OBJECTIVE
To report the primary (1-year) results from PREVENT, the first phase III study evaluating secukinumab in patients with active non-radiographic axial spondyloarthritis (nr-axSpA).
METHODS
A total of 555 patients were randomized (1:1:1) to subcutaneous secukinumab 150 mg with loading (LD), without loading (NL), or placebo weekly and then every 4 weeks starting at Week 4. NL group received placebo at Weeks 1, 2, and 3 to maintain blinding. Switch to open-label secukinumab (OL) or standard of care (SoC) was permitted after Week 20. The study had 2 independent analysis plans per EU and non-US (Plan A: Week 16) and US (Plan B: Week 52) regulatory requirements. Primary endpoint was ASAS40 at Week 16 (LD) and at Week 52 (NL) in tumor necrosis factor inhibitor (TNFi)-naïve patients. Safety analyses included all patients who received ≥1 dose of study treatment.
RESULTS
Overall, 481 patients completed 52 weeks treatment: 84.3% (156/185) LD, 89.7% (165/184) NL, and 86.0% (160/186) placebo. Proportion of patients who switched to OL or SoC between Weeks 20 and 48 was 50.8% LD, 47.3% NL, and 64.0% placebo. Both primary and all secondary endpoints were met at Week 16. ASAS40 in TNFi-naïve patients was significantly higher for LD (41.5%) at Week 16 and NL (39.8%) at Week 52 versus placebo (29.2% at Week 16 and 19.9% at Week 52; both P <0.05). No new safety findings were reported.
CONCLUSIONS
Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr-axSpA through 52 weeks. Safety was consistent with previous reports.",2020,"CONCLUSIONS
Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr-axSpA through 52 weeks.","['patients who received ≥1 dose of study treatment', 'A total of 555 patients', 'patients with active non-radiographic axial spondyloarthritis (nr-axSpA']","['subcutaneous secukinumab 150 mg with loading (LD), without loading (NL), or placebo', 'open-label secukinumab (OL) or standard of care (SoC', 'Secukinumab', 'ASAS40', 'placebo']",['signs and symptoms of non-radiographic axial spondyloarthritis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517810', 'cui_str': '555'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}]",555.0,0.186013,"CONCLUSIONS
Secukinumab 150 mg provided significant and sustained improvement in signs and symptoms of patients with nr-axSpA through 52 weeks.","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Hospital University Marqués de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilová', 'Affiliation': 'MEDICAL PLUS s.r.o., Uherske Hradiste, University of Veterinary and Pharmaceutical sciences, Brno, Czech Republic.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Monash University, Melbourne, Australia.'}, {'ForeName': 'Hideto', 'Initials': 'H', 'LastName': 'Kameda', 'Affiliation': 'Toho University, Tokyo, Japan.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'van de Sande', 'Affiliation': 'Amsterdam UMC, AMC/University of Amsterdam, Department of Rheumatology and Clinical Immunology, Amsterdam Infection & Immunity Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Wiksten', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Brian O', 'Initials': 'BO', 'LastName': 'Porter', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'Hanno B', 'Initials': 'HB', 'LastName': 'Richards', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Haemmerle', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Braun', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, and Ruhr-University Bochum, Bochum, Germany.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41477']
1776,32776202,Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO ® /DYNAGITO ® Trials.,"INTRODUCTION
Previous studies demonstrated that tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population.
METHODS
This post hoc analysis pooled data from TONADO ® 1 + 2 and DYNAGITO ® , three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received tiotropium/olodaterol 5/5 µg or tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use.
RESULTS
In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium. Lower rates of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with tiotropium/olodaterol versus tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium in patients receiving ICS.
CONCLUSIONS
Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice.
TRIAL REGISTRATION
TONADO ® 1 (ClinicalTrials.gov: NCT01431274); TONADO ® 2 (ClinicalTrials.gov: NCT01431287); DYNAGITO ® (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO ® 1 + 2 and DYNAGITO ® ) that looked at people who were taking tiotropium and olodaterol together and people who were taking tiotropium alone. We showed that, across a wide range of people, treatment with tiotropium/olodaterol was generally better at reducing exacerbations than tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with tiotropium. Overall, our results support the use of combined tiotropium/olodaterol in people at different stages of COPD.",2020,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","['patients with moderate-to-very severe COPD, with and without previous exacerbations, who received', 'patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD', 'People with chronic obstructive pulmonary disease (COPD']","['tiotropium/olodaterol versus tiotropium; GOLD', 'tiotropium/olodaterol 5/5\xa0µg or tiotropium 5\xa0µg', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'Tiotropium/olodaterol', 'inhaled medicine-tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['number of exacerbations', 'severe exacerbation rates', 'rate of moderate/severe exacerbations', 'Lower rates of moderate/severe exacerbations', 'Exacerbation Rates', 'exacerbations requiring hospitalisation', 'rates of moderate/severe exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",9942.0,0.709479,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","[{'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK. j.wedzicha@imperial.ac.uk.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anzueto', 'Affiliation': 'Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",Advances in therapy,['10.1007/s12325-020-01438-3']
1777,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION
Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS
EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION
The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER
NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
1778,32780999,"Prospective, randomized, double-blind, placebo-controlled evaluation of the Pharmacokinetics, Safety and Efficacy of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia.","BACKGROUND
Despite expectant management, preeclampsia remote from term usually results in preterm delivery. Antithrombin, which displays antiinflammatory and anticoagulant properties, may have a therapeutic role in treating preterm preeclampsia, a disorder characterized by endothelial dysfunction, inflammation, and activation of the coagulation system.
OBJECTIVE
This randomized, placebo-controlled clinical trial aimed to evaluate whether intravenous recombinant human antithrombin could prolong gestation and therefore improve maternal and fetal outcomes.
STUDY DESIGN
We performed a double-blind, placebo-controlled trial at 23 hospitals. Women were eligible if they had a singleton pregnancy, early-onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks' gestation, and planned expectant management. In addition to standard therapy, patients were randomized to receive either recombinant human antithrombin 250 mg loading dose followed by a continuous infusion of 2000 mg per 24 hours or an identical saline infusion until delivery. The primary outcome was days gained from randomization until delivery. The secondary outcome was composite neonatal morbidity score. A total of 120 women were randomized.
RESULTS
There was no difference in median gestational age at enrollment (27.3 weeks' gestation for the recombinant human antithrombin group [range, 23.1-30.0] and 27.6 weeks' gestation for the placebo group [range, 23.0-30.0]; P=.67). There were no differences in median increase in days gained (5.0 in the recombinant human antithrombin group [range, 0-75] and 6.0 for the placebo group [range, 0-85]; P=.95). There were no differences between groups in composite neonatal morbidity scores or in maternal complications. No safety issues related to recombinant human antithrombin were noted in this study, despite the achievement of supraphysiological antithrombin concentrations.
CONCLUSION
The administration of recombinant human antithrombin in preterm preeclampsia neither prolonged pregnancy nor improved neonatal or maternal outcomes.",2020,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"['120 women were randomized', 'Preterm Preeclampsia (PRESERVE-1', '23 hospitals', 'Women were eligible if they had a singleton pregnancy, early onset or superimposed preeclampsia at 23 0/7 to 30 0/7 weeks, and expectant management was planned']","['Placebo', 'Antithrombin', 'recombinant antithrombin', 'Recombinant Antithrombin Versus Placebo', 'placebo']","['composite neonatal morbidity score', 'median gestational age', 'composite neonatal morbidity scores', 'neonatal or maternal outcomes', 'days gained from randomization until delivery', 'median increase in days gained']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",120.0,0.711927,There were no differences between groups in composite neonatal morbidity scores or in maternal complications.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Paidas', 'Affiliation': 'Yale University School of Medicine, New Haven, CT. Electronic address: mxp1440@med.miami.edu.'}, {'ForeName': 'Allan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': 'University of Alabama at Birmingham School of Medicine, Birmingham, AL.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Saade', 'Affiliation': 'University of Texas Medical Branch, Galveston, TX.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Ehrenkranz', 'Affiliation': 'Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Triche', 'Affiliation': 'Brown University School of Medicine, Providence, RI.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Streisand', 'Affiliation': 'rEVO Biologics and LFB USA, Inc, Framingham, MA.'}, {'ForeName': 'Garrett K', 'Initials': 'GK', 'LastName': 'Lam', 'Affiliation': 'University of Tennessee College of Medicine, Memphis, TN.'}, {'ForeName': 'Everett F', 'Initials': 'EF', 'LastName': 'Magann', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Lewis', 'Affiliation': ""University of South Alabama Children's and Women's Hospital, Mobile, AL.""}, {'ForeName': 'Mitchell P', 'Initials': 'MP', 'LastName': 'Dombrowski', 'Affiliation': 'St. John Hospital and Medical Center, Detroit, MI.'}, {'ForeName': 'Erika F', 'Initials': 'EF', 'LastName': 'Werner', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': 'University of Utah Health, Salt Lake City, UT.'}, {'ForeName': 'Mounira A', 'Initials': 'MA', 'LastName': 'Habli', 'Affiliation': ""Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Grotegut', 'Affiliation': 'Duke University Health System, NC.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'The University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sherri A', 'Initials': 'SA', 'LastName': 'Longo', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, LA.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Amon', 'Affiliation': 'St. Louis University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Cleary', 'Affiliation': 'Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'How', 'Affiliation': 'Norton Healthcare, Louisville, KY.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Novotny', 'Affiliation': 'University of Mississippi Medical Center, Jackson, MS.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': 'Northwestern University School of Medicine, Chicago, IL.'}, {'ForeName': 'Valerie E', 'Initials': 'VE', 'LastName': 'Whiteman', 'Affiliation': 'University of South Florida, Tampa, FL.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Wing', 'Affiliation': 'University of California Irvine, Irvine, CA.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Scifres', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Baha M', 'Initials': 'BM', 'LastName': 'Sibai', 'Affiliation': 'University of Texas Health Sciences Center at Houston, Houston, TX.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.004']
1779,32798022,Resection following concurrent chemotherapy and high-dose radiation for stage IIIA non-small cell lung cancer.,"OBJECTIVE
Concern exists regarding surgery after thoracic radiation. We aimed to assess early results of anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation for resectable N2+ stage IIIA non-small cell lung cancer.
METHODS
Two prospective trials were recently conducted by NRG Oncology in patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839). All surgeons demonstrated postinduction resection expertise. Induction consisted of weekly carboplatin (area under the curve, 2.0) and paclitaxel (50 mg/m 2 ) and concurrent thoracic radiation 60 Gy (0839)/61.2 Gy (0229) in 30 fractions. Patients in study 0839 were randomized 2:1 to weekly panitumumab + chemoradiotherapy or chemoradiotherapy alone during induction. Primary results were similar in all treatment arms and reported previously. Short-term surgical outcomes are reported here.
RESULTS
One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection. Microscopically margin-negative resections occurred in 85 (91%). Fourteen (15%) resections were attempted minimally invasively, including 2 converted without event. Grade 3 or 4 surgical adverse events were reported in 26 (28%), 30-day mortality in 4 (4%) and 90-day mortality in 5 (5%). Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
CONCLUSIONS
Lobectomy was performed safely following full-dose concurrent chemoradiotherapy in these multi-institutional prospective trials; however, increased mortality was noted with extended resections.",2020,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","['patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839', 'One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection', 'stage IIIA non-small cell lung cancer']","['anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation', 'paclitaxel', 'carboplatin', 'concurrent chemotherapy and high-dose radiation', 'panitumumab\xa0+\xa0chemoradiotherapy or chemoradiotherapy']","['90-day mortality', 'Microscopically margin-negative resections', 'rates of grade 3 or 4 adverse events', 'mortality', '30-day mortality', 'Grade 3 or 4 surgical adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278983', 'cui_str': 'Non-small cell lung cancer stage IIIA'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",839.0,0.482473,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Donington', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill. Electronic address: jdonington@uchicago.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Krasna', 'Affiliation': 'Department of Surgery, Jersey Shore University Medical Center, Neptune City, NJ.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Suntharalingam', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Billy W', 'Initials': 'BW', 'LastName': 'Loo', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pa; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Ga.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.171']
1780,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE
This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS
Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS
The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS
The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
1781,32798570,Perceptual responses: Clinical versus practical blood flow restriction resistance exercise.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2 and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2 and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma, USA.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
1782,32816318,The effect of plasma melatonin levels in the treatment of lifelong premature ejaculation with selective serotonin reuptake inhibitors.,"The aim of our study was to compare melatonin levels of patients with lifelong premature ejaculation (LPE) (n:60) with healthy controls (n:30) and to investigate the changes of melatonin levels in the treatment with dapoxetine and sertraline. Age, body mass index, duration of marriage, weekly intercourse number, International Index of Erectile Function scores, Intravaginal Ejaculation Latency Time (IELT) and melatonin levels were recorded. LPE patients were divided into two treatment groups. The first group was included 30 patients, who received 60 mg dapoxetine for six weeks, twice a week, an hour before intercourse. The second group received 50 mg of sertraline daily, for six weeks. IELT and melatonin measures were repeated after the treatment. IELT (dapoxetine group: 41.22 ± 21.3 s, sertraline group: 48 ± 23.11 s, control group: 195.54 ± 84.14 s; p < .001) and melatonin levels (dapoxetine group: 5.75 ± 2.04 pg/mL, sertraline group: 5.49 ± 2.88 pg/mL, control group: 13.4 ± 12.09 pg/mL; p < .001) of both LPE groups were significantly lower than control group. Following the six-week sertraline (before: 48 ± 23.11 s, after: 101.01 ± 59.55 s; p < .001) and dapoxetine (before: 41.22 ± 21.3 s, after: 97.39 ± 44.1 s; p < .001) treatments, IELT increased. The melatonin levels increased in the sertraline group (before: 5.49 ± 2.88 pg/mL, after: 10.6 ± 7.37 pg/mL; p < .001). Our results indicate that melatonin levels of LPE patients are lower than levels of healthy volunteers. Furthermore, we found a significant increase in melatonin levels following sertraline treatment.",2020,"The melatonin levels increased in the sertraline group (before: 5.49 ± 2.88 pg/mL, after: 10.6 ± 7.37 pg/mL; p < .001).","['patients with lifelong premature ejaculation (LPE) (n:60) with healthy controls (n:30', 'lifelong premature ejaculation with selective serotonin reuptake inhibitors', 'healthy volunteers', 'LPE patients']","['60\xa0mg dapoxetine', 'melatonin levels (dapoxetine group: 5.75\xa0±\xa02.04\xa0pg/mL, sertraline', 'sertraline', 'dapoxetine and sertraline', '50\xa0mg of sertraline', 'plasma melatonin levels', 'LPE', 'IELT (dapoxetine']","['dapoxetine', 'melatonin levels', 'IELT and melatonin measures', 'Age, body mass index, duration of marriage, weekly intercourse number, International Index of Erectile Function scores, Intravaginal Ejaculation Latency Time (IELT) and melatonin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score'}]",,0.0703747,"The melatonin levels increased in the sertraline group (before: 5.49 ± 2.88 pg/mL, after: 10.6 ± 7.37 pg/mL; p < .001).","[{'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Kalkanli', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Cem Tugrul', 'Initials': 'CT', 'LastName': 'Gezmis', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Fikri', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nusret Can', 'Initials': 'NC', 'LastName': 'Cilesiz', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Ozkan', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eroglu', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Memduh', 'Initials': 'M', 'LastName': 'Aydin', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}]",Andrologia,['10.1111/and.13785']
1783,32757437,"Collaborative care for the wearable cardioverter defibrillator patient: Getting the patient and medical team ""vested and active"".","Patients with a reduced ejection fraction of 35% or less and a history of myocardial infarction (MI) are at increased risk of sudden cardiac death (SCD). These patients have a class I indication for an implantable cardioverter-defibrillator after allowing time for medical therapy optimization and potential cardiac recovery. The rates of SCD are highest in this ""gap"" period early after a cardiac event, and the wearable cardioverter-defibrillator (WCD) is an intervention that can be used to protect against SCD during this time period. There has been a clinical trial that randomized patients with a reduced ejection fraction at the time of MI to a WCD versus control. Results of the trial showed no statistically significant difference in the primary endpoint of SCD. There are many intricacies to the interpretation of the trial, including the importance of patient adherence to WCD therapy, which is affected by the patient experience and psychological factors. Patients with a new cardiomyopathy are affected by a mix of psychological factors, including the feeling of safety and protection from a WCD contrasted by the WCD providing a reminder of awareness and fear of ventricular arrhythmias and SCD. Beyond the capabilities of a WCD to defibrillate a life-threatening ventricular arrhythmia, the device can also provide activity and heart failure diagnostics monitoring. Patients need to be engaged in shared decision-making conversations about a WCD, so that patients can make a decision based on their own values construct, ultimately increasing adherence among the patients that want a WCD.",2020,Results of the trial showed no statistically significant difference in the primary endpoint of SCD.,"['Wearable Cardioverter Defibrillator Patient', 'Patients with a reduced ejection fraction of 35% or less and a history of myocardial infarction']",['implantable cardioverter-defibrillator'],"['rates of SCD', 'SCD', 'risk of sudden cardiac death (SCD']","[{'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1275835', 'cui_str': 'History of myocardial infarction'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0436581,Results of the trial showed no statistically significant difference in the primary endpoint of SCD.,"[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Sears', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Tripp', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Nichelle L', 'Initials': 'NL', 'LastName': 'Huber', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Saleen', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Cardiovascular Sciences, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Rajasekhar', 'Initials': 'R', 'LastName': 'Nekkanti', 'Affiliation': 'Department of Cardiovascular Sciences, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Burch', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, North Carolina, USA.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Pokorney', 'Affiliation': 'Division of Cardiology, Duke University, Durham, North Carolina, USA.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14708']
1784,32767636,A Randomised Controlled Trial Study of the Effects of a Digital Divorce Platform on Mental and Physical Health.,"BACKGROUND
Two decades of divorce research has consistently documented adverse mental and physical health effects of divorce. Responding to calls for evidence-based online divorce interventions, this study tests effects of the ""Cooperation after Divorce"" (CAD) digital intervention platform on divorcees' mental and physical health.
METHODS
Randomised control trial 12-month longitudinal study using a sample of 1,856 newly divorced Danes. Mental and physical health were measured using the SF-36 at baseline and 3, 6, and 12 months from baseline. Intervention effects were investigated using linear mixed effect models and Cohen's (d) for effect sizes.
RESULTS
The study found significant treatment effects of the CAD intervention on mental and physical health. These effects were evident across all eight health domains constituting the mental and physical health components. The study also found that the intervention group had significantly better mental health than the control group at subsequent 6- and 12-month assessments from baseline while for physical health, the intervention group had significantly better physical health at the 6-month assessment from baseline only.
CONCLUSION
The results indicate that digital solutions allowing for individually tailored user experiences may hold great potential in reducing well-known adverse health effects of divorce.
PRACTITIONER'S POINTS
The study finds highly significant treatment effects of the ""CAD"" digital divorce intervention on mental and physical health indicating that online interventions may be successfully integrated into help offered to divorcees post-divorce.",2020,"The results indicate that digital solutions allowing for individually tailored user experiences may hold great potential in reducing well-known adverse health effects of divorce.
","['1,856 newly divorced Danes']","['CAD intervention', 'Cooperation after Divorce"" (CAD) digital intervention platform', 'CAD"" digital divorce intervention', 'Digital Divorce Platform']","['mental and physical health', 'Mental and Physical Health', 'mental health', 'physical health', 'Mental and physical health']","[{'cui': 'C0012828', 'cui_str': 'Divorce'}, {'cui': 'C0337800', 'cui_str': 'Danes'}]","[{'cui': 'C0012828', 'cui_str': 'Divorce'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",1856.0,0.0429243,"The results indicate that digital solutions allowing for individually tailored user experiences may hold great potential in reducing well-known adverse health effects of divorce.
","[{'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Sander', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Gert Martin', 'Initials': 'GM', 'LastName': 'Hald', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cipric', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Camilla S', 'Initials': 'CS', 'LastName': 'Øverup', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Jenna Marie', 'Initials': 'JM', 'LastName': 'Strizzi', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Gad Kjeld', 'Affiliation': 'University of Copenhagen, Denmark.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, Denmark.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12213']
1785,32766705,Effectiveness of clinical decision support systems and telemedicine on outcomes of depression: a cluster randomized trial in general practice.,"BACKGROUND
Computerized Clinical Decision Support Systems (CCDSS) are information technology tools, designed to improve clinical decision-making. Telemedicine is a health care service delivery using videoconferencing, telephone or messaging technologies.
OBJECTIVES
Our project aimed at testing the effectiveness of a composite CCDSS and telemedicine approach designed to treat depression in primary care.
METHODS
This cluster randomized trial involved four GP clinics located in Northern Italy. Two clinics were assigned to the experimental protocol, and two served as controls. The study compared the telemedicine group (TG), in which GPs had access to a CCDSS platform, with the control group (CG) in which GPs provided treatment as usual (TAU). Patients scoring ≥11 on Patient Heath Questionnaire and ≥26 on the Inventory of Depressive Symptomatology-Self-Report were eligible for participation. Patients were also administered the World Health Organization Quality of Life-BREF to assess quality of life and Medical Interview Satisfaction Scale 21 to assess satisfaction with the medical interview.
RESULTS
Overall, 2810 patients were screened and 66 in the experimental group and 32 in the CG passed the screening stages and met inclusion criteria. The percentage of remitters at 6 months was significantly higher in the TG than in the CG group (24.1% versus 3.1%, χ 2 = 6.6, P = 0.01). This difference remained significant after adjusting for baseline confounders. Physical and psychological quality of life improved significantly from baseline in both groups. Patients reported, on average, good satisfaction with the medical interview.
CONCLUSIONS
Our study showed that a combined CCDSS and telemedicine approach may be more effective than the TAU offered by GPs to patients with depression.
TRIAL REGISTRATION
The trial was registered on https://clinicaltrials.gov/ on 5 October 2012 with identifier: NCT01701791. The first participant was enrolled on 5 May 2014 and the study was completed on May 2016.",2020,"The percentage of remitters at 6 months was significantly higher in the TG than in the CG group (24.1% versus 3.1%, χ 2 = 6.6, P = 0.01).","['four GP clinics located in Northern Italy', 'patients with depression', 'Patients scoring ≥11 on Patient Heath Questionnaire and ≥26 on the Inventory of Depressive Symptomatology-Self-Report were eligible for participation', 'The first participant was enrolled on 5 May 2014 and the study was completed on May 2016', '2810 patients were screened and 66 in the experimental group and 32 in the CG passed the screening stages and met inclusion criteria']","['telemedicine group (TG', 'composite CCDSS and telemedicine approach', 'clinical decision support systems and telemedicine', 'Telemedicine']","['outcomes of depression', 'World Health Organization Quality of Life-BREF to assess quality of life and Medical Interview Satisfaction Scale', 'percentage of remitters', 'Physical and psychological quality of life']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0582644', 'cui_str': 'Medical interview satisfaction scale'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",4.0,0.0825773,"The percentage of remitters at 6 months was significantly higher in the TG than in the CG group (24.1% versus 3.1%, χ 2 = 6.6, P = 0.01).","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Balestrieri', 'Affiliation': 'Unit of Psychiatry, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Sisti', 'Affiliation': ""Department of Biomolecular Sciences-Unit of Medical Statistic and Biometry, University of Urbino 'Carlo Bo', Urbino, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Rocchi', 'Affiliation': ""Department of Biomolecular Sciences-Unit of Medical Statistic and Biometry, University of Urbino 'Carlo Bo', Urbino, Italy.""}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Rucci', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Simon', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King's College London.""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Girolamo', 'Affiliation': 'Unit of Psychiatric Epidemiology and Evaluation, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}]",Family practice,['10.1093/fampra/cmaa077']
1786,32768597,Reply to letter to the editor: 'effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands - a randomized controlled trial'.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.0830795,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pelle', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: T.Pelle@maartenskliniek.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bevers', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Research Methodology, Measurement, and Data-Analysis, Behavioural, Management and Social Sciences, University of Twente, Enschede, the Netherlands; Medical School Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'F H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'C H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': 'Department of Rheumatology, Sint Maartenskliniek, Nijmegen, the Netherlands; Department of Rheumatic Diseases, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.07.007']
1787,32768599,Commentary on: effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands; a randomized controlled trial.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.10498,,"[{'ForeName': 'S F J', 'Initials': 'SFJ', 'LastName': 'Chudy', 'Affiliation': 'Erasmus MC, Netherlands. Electronic address: stanchudy@gmail.com.'}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Volwater', 'Affiliation': 'Leiden University, Netherlands. Electronic address: mike_volwater@hotmail.com.'}, {'ForeName': 'Ö F', 'Initials': 'ÖF', 'LastName': 'Ozbulut', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: o.ozbulut@erasmusmc.nl.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: b.koes@erasmusmc.nl.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.06.011']
1788,32770667,Pharmacokinetics and Bioequivalence Estimation of Two Formulations of Alfuzosin Extended-Release Tablets.,"Alfuzosin is a medication approved by the US Food and Drug Administration to treat benign prostatic hyperplasia symptoms. Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication. The aim of this study is to assess the bioavailability of the generic (test) and branded (reference) formulations of 10-mg alfuzosin extended-release tablets after oral administration to healthy adults under fed conditions. The study used a comparative randomized, single-dose, 2-way crossover open-label study design. Thirty-three participants were recruited and completed the clinical assessment. The pharmacokinetic parameters maximum plasma concentration (C max ), area under the plasma concentration-time curve (AUC 0-t ), AUC extrapolated to infinity (AUC 0-∞ ), time to maximum concentration, and elimination half-life were estimated to prove bioequivalence. The confidence intervals for the log-transformed test/reference ratios for alfuzosin 110.7% (98.0-124.9) and 112.0% (101.9-123.1) for C max and AUC 0-t respectively, which are within the allowed limits specified by the regulatory authorities (80-125% for C max and AUC 0-t ). The test formulation can therefore be prescribed as an alternative to the reference for symptomatic treatment of benign prostatic hyperplasia.",2020,Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication.,"['Thirty-three participants were recruited and completed the clinical assessment', 'healthy adults under fed conditions']","['Alfuzosin Extended-Release Tablets', '10-mg alfuzosin', 'Alfuzosin', 'alfuzosin']","['pharmacokinetic parameters maximum plasma concentration (C max ), area under the plasma concentration-time curve (AUC 0-t ), AUC extrapolated to infinity (AUC 0-∞ ), time to maximum concentration, and elimination half-life']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0051150', 'cui_str': 'alfuzosin'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",33.0,0.0447721,Bioequivalence studies are demanded by regulatory authorities to evaluate the expected in vivo biological similarity of 2 formulations of a medication.,"[{'ForeName': 'Abdel Qader', 'Initials': 'AQ', 'LastName': 'Al Bawab', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.'}, {'ForeName': 'Bashar A', 'Initials': 'BA', 'LastName': 'Alkhalidi', 'Affiliation': 'School of Pharmacy, The University of Jordan, Amman, Jordan.'}, {'ForeName': ""Esra'a"", 'Initials': 'E', 'LastName': 'Albarahmieh', 'Affiliation': 'School of Applied Medical Sciences, German Jordanian University, Amman, Jordan.'}, {'ForeName': 'Sami M A', 'Initials': 'SMA', 'LastName': 'Qassim', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammad A D', 'Initials': 'MAD', 'LastName': 'Al-Saifi', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Al-Saifi', 'Affiliation': 'Tabuk Pharmaceuticals, Tabuk, Kingdom of Saudi Arabia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': 'University of Sunderland, Sunderland, UK.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Al-Qerem', 'Affiliation': 'Faculty of Pharmacy, Al-Zaytoonah University of Jordan, Amman, Jordan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.860']
1789,32779096,"IncobotulinumtoxinA for the Treatment of Blepharospasm in Toxin-Naïve Subjects: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial.","This study aimed to assess the efficacy/safety of incobotulinumtoxinA (Xeomin ® , Merz Pharmaceuticals GmbH) in botulinum neurotoxin-naïve subjects with blepharospasm. Botulinum neurotoxin-naïve subjects (≥ 12 months without botulinum neurotoxin treatment for blepharospasm) received single-dose incobotulinumtoxinA 50 U, 25 U, or placebo. Subjects were followed for 6-20 weeks (main period). Qualified subjects entered an open-label extension period and received another incobotulinumtoxinA injection (≤ 70 U). The primary efficacy variable was change from baseline in the Jankovic Rating Scale (JRS) severity subscore at the main period of week 6. Other efficacy variables included changes in the Blepharospasm Disability Index score and JRS frequency subscore and sumscore. Adverse events were monitored. Sixty-one subjects were randomized (main period: incobotulinumtoxinA 50 U, n = 19; incobotulinumtoxinA 25 U, n = 22; placebo, n = 20); 39 entered the open-label extension period (9, 14, and 16 subjects from the incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo groups [main period], respectively, changed to open-label extension period dosing). A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004). Subjects receiving incobotulinumtoxinA experienced improvements in other efficacy variables versus baseline and/or placebo. Sustained clinical improvements and low adverse event rates (22.2-42.1%) were observed. This is the second placebo-controlled, double-blind study that demonstrates favorable efficacy/safety of incobotulinumtoxinA in subjects with blepharospasm. IncobotulinumtoxinA is the first botulinum neurotoxin that could fulfill the American Academy of Neurology criteria for a Level A recommendation for blepharospasm.Trial registration ClinicalTrials.gov identifier, NCT01896895.",2020,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","['botulinum neurotoxin-naïve subjects with blepharospasm', 'Sixty-one subjects were randomized (main period', 'subjects with blepharospasm']","['IncobotulinumtoxinA', 'Placebo', 'incobotulinumtoxinA 50 U, n\u2009=\u200919; incobotulinumtoxinA 25 U, n\u2009=\u200922; placebo, n\u2009=\u200920', 'Botulinum neurotoxin-naïve subjects (≥\u200912\xa0months without botulinum neurotoxin', 'incobotulinumtoxinA', 'incobotulinumtoxinA injection', 'single-dose incobotulinumtoxinA 50 U, 25\xa0U, or placebo', 'incobotulinumtoxinA 50 U, incobotulinumtoxinA 25 U, and placebo', 'placebo']","['low adverse event rates', 'Adverse events', 'Blepharospasm Disability Index score and JRS frequency subscore and sumscore', 'Jankovic Rating Scale (JRS) severity subscore', 'JRS severity subscore']","[{'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005747', 'cui_str': 'Blepharospasm'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",61.0,0.42825,"A statistically significantly greater reduction in JRS severity subscore was reported for subjects receiving incobotulinumtoxinA 50 U versus placebo (ANCOVA, least square mean difference: - 1.2, p = 0.0004).","[{'ForeName': 'Dimos D', 'Initials': 'DD', 'LastName': 'Mitsikostas', 'Affiliation': '1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece. dimosmitsikostas@icloud.com.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Sternberg', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Althaus', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pagan', 'Affiliation': 'Department of Neurology, Georgetown University Hospital Pasquerilla Healthcare Center, Washington, DC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01427-6']
1790,32776861,Affective responses to high-intensity interval training with continuous and respite music.,"Music has been shown to enhance affective responses to continuous exercise, but the most effective application of music during interval exercise is poorly understood. This study examined two contrasting applications of music designed to assuage the decline in pleasure often experienced during high-intensity interval training (HIIT). In a repeated measures crossover design, 18 recreationally active participants (10 men and 8 women; M age = 25.1 ± 5.1 years; M BMI = 23.08 ± 2.01 kg/m 2; M VO 2max = 38.82 ± 10.73 ml/kg/min) completed three HIIT sessions (10 x 60 s efforts at 100% Wmax, separated by 75 s recovery) on a cycle ergometer. Participants completed two experimental conditions: respite music (applied only during the recovery periods), continuous music (applied throughout the entire HIIT session); and a no-music control condition. Results indicated that music did not influence affective valence during the work bouts or recovery periods of the HIIT sessions ( p s >.05), but that listening to music continuously elicited greater post-task enjoyment ( p =.032, d = 0.66) and remembered pleasure ( p =.044, d = 0.5). This study is the first to investigate the application of music during a practical HIIT protocol and to compare the effects of respite versus continuous music during interval exercise.",2020,"Results indicated that music did not influence affective valence during the work bouts or recovery periods of the HIIT sessions ( p s >.05), but that listening to music continuously elicited greater post-task enjoyment ( p =.032, d = 0.66) and remembered pleasure ( p =.044, d = 0.5).",['18 recreationally active participants (10 men and 8 women; M age \xa0=\xa025.1\xa0±\xa05.1\xa0years; M BMI \xa0=\xa023.08\xa0±\xa02.01 kg/m 2; M VO 2max \xa0=\xa038.82\xa0±\xa010.73'],"['respite music (applied only during the recovery periods), continuous music (applied throughout the entire HIIT session); and a no-music control condition', 'respite versus continuous music during interval exercise', 'HIIT sessions ', 'high-intensity interval training with continuous and respite music']","['remembered pleasure', 'affective valence', 'listening to music continuously elicited greater post-task enjoyment', 'Affective responses']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",,0.0607468,"Results indicated that music did not influence affective valence during the work bouts or recovery periods of the HIIT sessions ( p s >.05), but that listening to music continuously elicited greater post-task enjoyment ( p =.032, d = 0.66) and remembered pleasure ( p =.044, d = 0.5).","[{'ForeName': 'Leighton', 'Initials': 'L', 'LastName': 'Jones', 'Affiliation': 'Department of Sport and Physical Activity, Sheffield Hallam University , Sheffield, UK.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Stork', 'Affiliation': 'School of Health and Exercise Sciences, The University of British Columbia , Kelowna, Canada.'}, {'ForeName': 'Liam S', 'Initials': 'LS', 'LastName': 'Oliver', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology , Brisbane, Australia.'}]",Journal of sports sciences,['10.1080/02640414.2020.1801324']
1791,32782170,Effect of GnRH agonist before IVF on outcomes in infertile endometriosis patients: a randomized controlled trial.,"RESEARCH QUESTION
Does 3-months of gonadotrophin releasing hormone agonist (GnRHa) treatment before IVF improve clinical pregnancy rate in infertile patients with endometriosis?
DESIGN
Single-blind, placebo-controlled clinical trial of 200 infertile women with endometriosis assigned to use GnRHa (study group) or placebo (control group) for 3 months before IVF. Clinical, embryological outcomes and stimulation parameters were analysed. Clinical pregnancy rate was the primary endpoint. In a subgroup of 40 patients, follicular fluid levels of oestradiol, testosterone and androstendione were measured. Gene expression profile of CYP19A1 was analysed in cumulus and mural granulosa cells.
RESULTS
Implantation or clinical pregnancy rate were not significantly different between the two groups. Clinical pregnancy rates were 25.3% and 33.7% in the study and control groups, respectively (P = 0.212). Cumulative live birth rate was not significantly different: 22.0% (95% CI 13.0 to 31.0) in the study group and 33.7% (95% CI 24.0 to 44.0) in the control group (P = 0.077). Ovarian stimulation was significantly longer and total dose of gonadotrophins significantly higher in the study group (both P < 0.001). Serum oestradiol levels on the day of HCG were significantly lower in the study group (P = 0.001). Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023). No significant differences in the expression of CYP19A1 gene in mural or cumulus granulosa cells or steroid levels in follicular fluid between the two groups were observed, but testosterone was significantly lower in the study group (P < 0.001).
CONCLUSION
Three-months of GnRHa treatment before IVF does not improve clinical pregnancy rate in women with endometriosis.",2020,"Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023).","['infertile endometriosis patients', '200 infertile women with endometriosis assigned to use GnRHa (study group) or', 'infertile patients with endometriosis', 'women with endometriosis']","['GnRH agonist before IVF', 'gonadotrophin releasing hormone agonist (GnRHa) treatment before IVF', 'placebo']","['clinical pregnancy rate', 'Clinical pregnancy rate', 'Ovarian stimulation', 'total dose of gonadotrophins', 'cleavage embryos', 'Cancellation rate', 'Cumulative live birth rate', 'Implantation or clinical pregnancy rate', 'Serum oestradiol levels', 'expression of CYP19A1 gene in mural or cumulus granulosa cells or steroid levels in follicular fluid', 'Clinical pregnancy rates', 'follicular fluid levels of oestradiol, testosterone and androstendione', 'Gene expression profile of CYP19A1']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0059735', 'cui_str': 'Cytochrome p450 CYP1A1 enzyme'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0441995', 'cui_str': 'Mural'}, {'cui': 'C1956101', 'cui_str': 'Granulosa Cells, Cumulus'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016431', 'cui_str': 'Liquor Folliculi'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}]",200.0,0.487422,"Cancellation rate was significantly higher in the study group (P = 0.042), whereas cleavage embryos were significantly more numerous in the control group (P = 0.023).","[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Rodríguez-Tárrega', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain. Electronic address: e.rodriguez.tarrega@gmail.com.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Monzo', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Ramiro', 'Initials': 'R', 'LastName': 'Quiroga', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Patrocinio', 'Initials': 'P', 'LastName': 'Polo-Sánchez', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Fernández-Colom', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Monterde-Estrada', 'Affiliation': 'Human Reproduction Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Edurne', 'Initials': 'E', 'LastName': 'Novella-Maestre', 'Affiliation': 'Genetic Unit, University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pellicer', 'Affiliation': 'Reproductive Medicine Research Group. Instituto de Investigación Sanitaria La Fe. University Hospital La Fe, Avenida de Fernando Abril Martorell, 106, Valencia 46026, Spain; IVI Rome. Largo Ildebrando Pizzeti, Rome 00197, Italy.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.06.020']
1792,32782181,Text-only and picture conversation aids both supported shared decision making for breast cancer surgery: Analysis from a cluster randomized trial.,"OBJECTIVES
To determine if two encounter conversation aids for early-stage breast cancer surgery increased observed and patient-reported shared decision making (SDM) compared with usual care and if observed and patient-reported SDM were associated.
METHODS
Surgeons in a cluster randomized trial at four cancer centers were randomized to use an Option Grid, Picture Option Grid, or usual care. We used bivariate statistics, linear regression, and multilevel models to evaluate the influence of trial arm, patient socioeconomic status and health literacy on observed SDM (via OPTION-5) and patient-reported SDM (via collaboRATE).
RESULTS
From 311 recordings, OPTION-5 scores were 73/100 for Option Grid (n = 40), 56.3/100 for Picture Option Grid (n = 144), and 41.0/100 for usual care (n = 127; p < 0.0001). Top collaboRATE scores were 81.6 % for Option Grid, 80.0 % for Picture Option Grid, and 56.4 % for usual care (p < 0.001). Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis. Patients of lower socioeconomic status had lower OPTION-5 scores before accounting for clustering.
CONCLUSIONS
Both conversation aids led to meaningfully higher observed and patient-reported SDM. Observed and patient-reported SDM were not strongly correlated.
PRACTICE IMPLICATIONS
Healthcare providers could implement these conversation aids in real-world settings.",2020,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","['Surgeons in a cluster randomized trial at four cancer centers', 'breast cancer surgery']","['Option Grid, Picture Option Grid, or usual care', 'Text-only and picture conversation aids both supported shared decision making']",[],"[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}]",[],,0.13711,"Top collaboRATE scores correlated with an 8.60 point (95 %CI 0.66, 13.7) higher OPTION-5 score (p = 0.008) with no correlation in the multilevel analysis.","[{'ForeName': 'Renata W', 'Initials': 'RW', 'LastName': 'Yen', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Durand', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Université Toulouse III Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Ward', 'Affiliation': 'Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': ""O'Malley"", 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schubbe', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Saunders', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA; Centers for Health and Aging, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Elwyn', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Dartmouth College, Lebanon, NH, USA. Electronic address: glynelwyn@gmail.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.015']
1793,32789809,Pharmacokinetic and Pharmacodynamic Equivalence of Pegfilgrastim-cbqv and Pegfilgrastim in Healthy Subjects.,"INTRODUCTION
Pegfilgrastim-cbqv was developed as a biosimilar of pegfilgrastim, a pegylated form of recombinant human granulocyte colony-stimulating factor approved for decreasing febrile neutropenia-associated infection in patients receiving myelosuppressive drugs. This multicenter, randomized, single-blind, partial-reference-replicated, three-sequence crossover study assessed pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv and pegfilgrastim in healthy subjects.
METHODS
One hundred twenty-two subjects were randomized to one of three treatment sequences; each included one dose of pegfilgrastim-cbqv and two doses of pegfilgrastim separated by ≥ 28 days. The primary pharmacokinetic end points were area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ). The primary pharmacodynamic end points were maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ). Pharmacokinetic and pharmacodynamic bioequivalences were demonstrated if the 90% CI for the geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim was within 80-125% for the primary end points.
RESULTS
Pharmacokinetic bioequivalence criteria were met for C max (GMR 105.0; 90% CI 95.5-115.4) and AUC 0-∞ (GMR 97.5; 90% CI 88.6-107.2). Pharmacodynamic bioequivalence criteria were met for ANC max (GMR 99.6; 90% CI 96.2-103.2) and ANC AUC 0-last (GMR 96.7; 90% CI 92.2-101.4). Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively. Investigators found no drug-related serious adverse events.
CONCLUSION
This study established pharmacokinetic and pharmacodynamic bioequivalence of pegfilgrastim-cbqv to pegfilgrastim. The treatments displayed similar safety profiles, including immunogenicity, with no unexpected safety findings.
CLINICAL TRIALS REGISTRATION
ClinicalTrials.gov, NCT02650973, February 2016.",2020,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","['One hundred twenty-two subjects', 'patients receiving myelosuppressive drugs', 'healthy subjects', 'Healthy Subjects']","['pegfilgrastim-cbqv and pegfilgrastim', 'pegfilgrastim-cbqv and two doses of pegfilgrastim separated by\u2009≥', 'recombinant human granulocyte colony-stimulating factor', 'Pegfilgrastim-cbqv and Pegfilgrastim', 'pegfilgrastim-cbqv to pegfilgrastim']","['geometric mean ratio (GMR) of pegfilgrastim-cbqv to pegfilgrastim', 'area under the curve (AUC) from 0 to infinity (AUC 0-∞ ) and maximum concentration (C max ', 'Adverse events', 'pharmacokinetic and pharmacodynamic bioequivalence', 'Pharmacokinetic and pharmacodynamic bioequivalences', 'Pharmacokinetic and Pharmacodynamic Equivalence', 'maximum absolute neutrophil count (ANC max ) and ANC AUC from time 0 to the last measurable observation (ANC AUC 0-last ']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1271481', 'cui_str': 'Recombinant human granulocyte colony stimulating factor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4735048', 'cui_str': 'pegfilgrastim-cbqv'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",122.0,0.0612766,"Adverse events occurred in 76.0%, 76.6%, and 73.1% of subjects for pegfilgrastim-cbqv, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Finck', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA. bfinck@coherus.com.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Civoli', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hodge', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': ""O'Kelly"", 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vexler', 'Affiliation': 'Coherus BioSciences, Redwood City, CA, USA.'}]",Advances in therapy,['10.1007/s12325-020-01459-y']
1794,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND
Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD
We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS
Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS
In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
1795,32795623,Effects of flexibility and strength training on peak hamstring musculotendinous strains during sprinting.,"BACKGROUND
Hamstring injury is one of the most common injuries in sports involving sprinting. Hamstring flexibility and strength are often considered to be modifiable risk factors in hamstring injury. Understanding the effects of hamstring flexibility or strength training on the biomechanics of the hamstring muscles during sprinting could assist in improving prevention strategies and rehabilitation related to these injuries. The purpose of this study was to determine the effects of altering hamstring flexibility or strength on peak hamstring musculotendinous strain during sprinting.
METHODS
A total of 20 male college students (aged 18-24 years) participated and were randomly assigned to either a flexibility-intervention group or a strength-intervention group. Each participant executed exercise training 3 times a week for 8 weeks. Flexibility, sprinting, and isokinetic strength testing were performed before and after the 2 interventions. Paired t tests were performed to determine hamstring flexibility or strength intervention effects on optimal hamstring musculotendinous lengths and peak hamstring musculotendinous strains during sprinting.
RESULTS
Participants in the flexibility intervention group significantly increased the optimal musculotendinous lengths of the semimembranosus and biceps long head (p ≤ 0.026) and decreased peak musculotendinous strains in all 3 bi-articulate hamstring muscles (p ≤ 0.004). Participants in the strength-intervention group significantly increased the optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
CONCLUSION
Increasing hamstring flexibility or strength through exercise training may assist in reducing the risk of hamstring injury during sprinting for recreational male athletes.",2020,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","['peak hamstring musculotendinous strains during sprinting', '20 male college students (aged 18-24 years', 'recreational male athletes']","['exercise training', 'flexibility intervention group or a strength intervention group', 'flexibility and strength training', 'hamstring flexibility or strength', 'hamstring flexibility or strength training']","['peak musculotendinous strains', 'peak musculotendinous strain', 'Hamstring flexibility and strength', 'optimal musculotendinous lengths of the semimembranosus and biceps long head', 'optimal musculotendinous lengths of all 3 hamstring muscles', 'Flexibility, sprinting and isokinetic strength testing']","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0224452', 'cui_str': 'Semimembranosus muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",20.0,0.0138512,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","[{'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Shangxiao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Best', 'Affiliation': 'UHealth Sports Medicine Institute, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China. Electronic address: lihanjun@bsu.edu.cn.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Center for Human Movement Science, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7135, USA. Electronic address: byu@med.unc.edu.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.08.001']
1796,32811623,A randomized comparison of extended-release naltrexone with or without patient navigation vs enhanced treatment-as-usual for incarcerated adults with opioid use disorder.,"The high prevalence of opioid use among justice-involved adults make jails an exceptional setting to initiate opioid use disorder (OUD) treatment, but optimal strategies for delivering these interventions are still not well understood. The objective of this study was to conduct a randomized controlled trial to assess the effectiveness of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc) alone or in conjunction with patient navigation (XR-NTX + PN) for jail inmates with OUD. We randomized a sample of 135 sentenced jail inmates with moderate to severe OUD to (1) XR-NTX only; (2) XR-NTX + PN; or (3) enhanced treatment-as-usual (ETAU) with drug education, each initiated prior to release from jail. We scheduled follow-up data assessments at 1, 3, 6, and 12 months post-release. Primary outcomes were opioid use (based on Timeline Followback Interview and Addiction Severity Index) and meeting CIDI DSM-5 criteria for OUD 6 months postrelease. We also measured treatment adherence, HIV risk, and recidivism. XR-NTX participants received a mean of 2.26 of 7 possible injections compared to XR-NTX + PN participants, who received a mean of 2.93 injections (Cohen's d = 0.33, 95% CI: -0.09 to 0.74). Thirty-six percent of patients in XR-NTX + PN attended at least one postrelease PN session. We found no significant differences by study condition six months after release from jail for the primary outcomes of any opioid use (ETAU: 17%, XR-NTX: 16%, XR-NTX + PN: 29%) and past 30-day OUD (ETAU: 8%, XR-NTX: 11%, XR-NTX + PN: 10%). Secondary outcomes of rearrest and HIV risk also were similar across groups, with the exception of lower sex-related HIV risk among those in the XR-NTX condition at 12 months. This study did not show superior outcomes of XR-NTX or XR-NTX + PN with regard to opioid use or recidivism outcomes, relative to ETAU. It did, however, highlight the difficulties with adherence to XR-NTX and PN interventions in OUD patients initiating treatment in jail.",2020,"We found no significant differences by study condition six months after release from jail for the primary outcomes of any opioid use (ETAU: 17%, XR-NTX: 16%, XR-NTX + PN: 29%) and past 30-day OUD (ETAU: 8%, XR-NTX: 11%, XR-NTX + PN: 10%).","['incarcerated adults with opioid use disorder', '135 sentenced jail inmates with moderate to severe OUD to (1) XR-NTX only; (2) XR-NTX\xa0+\xa0PN; or (3) enhanced treatment-as-usual (ETAU) with drug education, each initiated prior to release from jail', 'OUD patients initiating treatment in jail', 'jail inmates with OUD']","['extended-release naltrexone with or without patient navigation vs enhanced treatment-as-usual for', 'extended-release naltrexone (XR-NTX, Vivitrol®', 'patient navigation (XR-NTX\xa0+\xa0PN']","['treatment adherence, HIV risk, and recidivism', 'rearrest and HIV risk', 'opioid use (based on Timeline Followback Interview and Addiction Severity Index) and meeting CIDI DSM-5 criteria for OUD 6\xa0months postrelease']","[{'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0542304', 'cui_str': 'Medication education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C1712071', 'cui_str': 'Vivitrol'}]","[{'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",135.0,0.0582878,"We found no significant differences by study condition six months after release from jail for the primary outcomes of any opioid use (ETAU: 17%, XR-NTX: 16%, XR-NTX + PN: 29%) and past 30-day OUD (ETAU: 8%, XR-NTX: 11%, XR-NTX + PN: 10%).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farabee', 'Affiliation': 'Department of Population Health, New York University; 180 Madison Ave, 17(th) Floor, New York, NY 10016, United States of America. Electronic address: David.Farabee@nyulangone.org.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Condon', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, UW Medical Center, Box 356560, 1959 NE Pacific St., Seattle, WA 98195, United States of America.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McCrady', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108076']
1797,32811625,Temporal dynamics of the relationship between change in depressive symptoms and cannabis use in adolescents receiving psychosocial treatment for cannabis use disorder.,"AIMS
Cannabis use disorder (CUD) and depression frequently co-occur in youth. How depressive symptoms change over the course of CUD treatment and how they impact substance use treatment outcomes is unknown. In the current study, we examine the temporal relationships between cannabis use and depression in adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial.
DESIGN
Six hundred adolescents (age 12-18) with a CUD were randomly assigned to substance use treatment from one of five evidence-based psychosocial interventions. We assessed self-reported cannabis use frequency and depressive symptoms at baseline (BL) and again at 3-, 6-, 9, and 12-months. A bivariate latent change model assessed bidirectional effects of baseline levels and time-lagged changes in depressive symptoms and cannabis use on depression and cannabis use outcomes.
FINDINGS
Depressive symptoms (72%) and major depressive disorder (MDD) (18%) were common at BL. Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003). Time-lag analyses showed that within-subject change in depression (from one time point to the next) was predicted by previous depression (b = -0.71, p < .001) but not cannabis use (p = .068), and change (decrease) in cannabis use was predicted by previous (greater) depressive symptoms (b = -1.47, p < .001) but not cannabis use (p = .158), respectively.
CONCLUSION
These findings indicate an enduring relationship between decreasing cannabis use and decreasing depression among adolescents lasting for 9-months after receiving psychosocial interventions for CUD. The presence of depressive symptoms did not appear to interfere with substance use treatment or attenuate improvements in cannabis use frequency. A decrease in cannabis use was not contingent upon a reduction in depressive symptoms. These findings are limited by the possibility of regression to the mean for both cannabis use and depressive symptoms, and the lack of a nonintervention control group.",2020,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","['adolescents receiving psychosocial treatment for cannabis use disorder', 'adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial', 'Six hundred adolescents (age 12-18) with a CUD']",[],"['major depressive disorder (MDD', 'depression', 'depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",600.0,0.127233,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","[{'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Virginia Commonwealth University, United States of America. Electronic address: albert.arias@vcuhealth.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hammond', 'Affiliation': 'Johns Hopkins University School of Medicine, United States of America. Electronic address: chammo20@jhmi.edu.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Burleson', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: burleson@uchc.edu.'}, {'ForeName': 'Yifrah', 'Initials': 'Y', 'LastName': 'Kaminer', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: kaminer@uchc.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feinn', 'Affiliation': 'Quinnipiac University School of Medicine, United States of America. Electronic address: richard.feinn@quinnipiac.edu.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Curry', 'Affiliation': 'Duke University School of Medicine, United States of America. Electronic address: john.curry@duke.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Dennis', 'Affiliation': 'Chestnut Health Systems, United States of America. Electronic address: mdennis@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108087']
1798,32811628,A randomized clinical trial of smartphone self-managed recovery support services.,"This study examines the effectiveness of smartphone-based ecological momentary interventions (EMI) and assessments (EMA), delivered separately and combined, to provide recovery support following substance use disorder (SUD) treatment engagement. We recruited adults (N = 401) from SUD treatment programs in Chicago and, after engagement for at least two sessions, nights, or medication dosages, we randomly assigned them to one of four conditions that lasted 6 months: (1) EMI only, (2) EMA only, (3) both EMI and EMA, and (4) control condition of neither EMI nor EMA. EMIs provided support for recovery through applications on the phone or links to other resources; EMAs were delivered randomly 5 times per day asking participants to indicate recent substance use and situational risk and protective factors. The primary dependent variable was days of abstinence in the 6 months following study intake. Rates of EMI and EMA utilization indicated high compliance, although EMI use decreased over time. There was a small direct effect of time across conditions (F (2,734) = 4.33, p = .014, Cohen's f = 0.11) and a small direct effect of time-by-EMI use (F (2,734) = 4.85, p = .009, f = 0.11) on days of abstinence. There was no significant direct effect of time-by-EMAs nor interaction effect of time-by-EMI-by-EMA. However, secondary path model analyses showed a small but significant indirect effect of EMA on abstinence via EMI use. Stepwise modeling identified a simplified model based on the proportion of weeks using ≥1 EMI and the EMI to listen to music, which predicted 7.2% of the variance in days of abstinence (F (2,195,) = 7.56, p < .001). Combined delivery of EMI and EMA shows potential for increasing abstinence above and beyond the effect of SUD treatment engagement and for addressing the limited national capacity for recovery support.",2020,There was no significant direct effect of time-by-EMAs nor interaction effect of time-by-EMI-by-EMA.,"['recruited adults (N\xa0=\xa0401) from SUD treatment programs in Chicago and, after engagement for at least two sessions, nights, or medication dosages']","['EMI and EMA', 'smartphone self-managed recovery support services', 'smartphone-based ecological momentary interventions (EMI) and assessments (EMA', 'EMA']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0268596', 'cui_str': 'Glutaric aciduria, type 2'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],,0.0453708,There was no significant direct effect of time-by-EMAs nor interaction effect of time-by-EMI-by-EMA.,"[{'ForeName': 'Christy K', 'Initials': 'CK', 'LastName': 'Scott', 'Affiliation': 'Chestnut Health Systems, 221 W. Walton St., Chicago, IL 60610, United States of America. Electronic address: cscott@chestnut.org.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Dennis', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Dr., Normal, IL 61761, United States of America. Electronic address: mdennis@chestnut.org.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Johnson', 'Affiliation': 'University of South Florida, 4202 E. Fowler Ave., Tampa, FL 33620, United States of America. Electronic address: kjohnson33@usf.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Grella', 'Affiliation': 'Chestnut Health Systems, 221 W. Walton St., Chicago, IL 60610, United States of America. Electronic address: cegrella@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108089']
1799,32811629,Factors associated with withdrawal symptoms and anger among people resuscitated from an opioid overdose by take-home naloxone: Exploratory mixed methods analysis.,"INTRODUCTION
Take-home naloxone (THN) is a clinically effective and cost-effective means of reducing opioid overdose fatality. Nonetheless, naloxone administration that successfully saves a person's life can still produce undesirable and harmful effects.
AIM
To better understand factors associated with two widely reported adverse outcomes following naloxone administration; namely the person resuscitated displays: i. withdrawal symptoms and ii. anger.
METHODS
A mixed methods study combining a randomized controlled trial of overdose education and naloxone prescribing to people with opioid use disorder and semi-structured qualitative interviews with trial participants who had responded to an overdose whilst in the trial. All data were collected in New York City (2014-2019). A dataset (comprising demographic, pharmacological, situational, interpersonal, and overdose training related variables) was generated by transforming qualitative interview data from 47 overdose events into dichotomous variables and then combining these with quantitative demographic and overdose training related data from the main trial. Associations between variables within the dataset and reports of: i. withdrawal symptoms and ii. anger were explored using chi-squared tests, t-tests, and logistic regressions.
RESULTS
A multivariate logistic regression found that people who had overdosed were significantly more likely to display anger if the person resuscitating them criticized, berated or chastised them during resuscitation (adjusted OR = 27 [95% CI = 4.0-295]). In contrast, they were significantly less likely to display anger if the person resuscitating them communicated positively with them (OR = 0.10 [95% CI = 0.01-0.78]). Both positive and negative communication styles were independently associated with anger, and communication was associated with 59% of the variance in anger. There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
CONCLUSIONS
Contrary to common assumptions, withdrawal symptoms and anger following naloxone administration may be unrelated phenomena. Findings are consistent with previous research that has suggested that a lay responder's positive or reassuring communication style may lessen anger post overdose. Implications for improving THN programmes and naloxone administration are discussed.",2020,"There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
","['people with opioid use disorder and semi-structured qualitative interviews with trial participants who had responded to an overdose whilst in the trial', 'person resuscitated displays']","['overdose education and naloxone', 'naloxone (THN', 'naloxone']",['withdrawal symptoms'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}]",,0.126341,"There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: joanne.neale@kcl.ac.uk.""}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Kalk', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: nicola.kalk@kcl.ac.uk.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom. Electronic address: caral.brown@kcl.ac.uk.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: lb3227@cumc.columbia.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: felipe.castillo@nyspi.columbia.edu.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: jermaine.jones@nyspi.columbia.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: john.strang@kcl.ac.uk.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: sdc10@cumc.columbia.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108099']
1800,32820647,"Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network's Marfan Trial experience.","BACKGROUND/AIMS
The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies.
METHODS
Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence.
RESULTS
Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
CONCLUSION
Overall adherence was excellent for this trial conducted within a National Institutes of Health-funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.",2020,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","['young adults and African Americans', 'Young adult and African American participants', 'eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise', '608 children and young adults with Marfan syndrome']","['losartan', 'atenolol']","['Medication adherence', 'Recruitment, retention, and adherence questionnaires', 'Retention', 'mean percentage of medication taken', 'Completion rates for visits, Holter monitors, and quarterly calls', 'completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls', 'Recruitment, retention, and adherence', 'Protocol adherence', 'Overall adherence', 'lower levels of adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013799', 'cui_str': 'Ambulatory ECG'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",608.0,0.169075,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cnota', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cappella', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'De Nobele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Grima', 'Affiliation': 'The Marfan Foundation, Port Washington, NY, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Korsin', 'Affiliation': ""Children's Hospital of New York, New York, NY, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': ""Primary Children's Hospital, University of Utah, Salt Lake City, UT, USA.""}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'MacNeal', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': ""The Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, USA.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'MacCarrick', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Sylvester', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520945988']
1801,32826122,Evidence-Based Medicine Improves the Emergent Management of Peritonsillar Abscesses Using Point-of-Care Ultrasound.,"BACKGROUND
Physical examination for peritonsillar abscess (PTA) has limited sensitivity. Traditional management involves blind needle aspiration, which has a false negative rate of 10-24%. A randomized controlled trial by Costantino et al. demonstrated that point-of-care ultrasound (POCUS) improves PTA management.
OBJECTIVES
Compare the use and impact of POCUS between patient cohorts prior to and after the trial by Costantino et al.
METHODS
Retrospective cohort study of adult patients diagnosed with PTA. Cohort 1 presented to the emergency department (ED) January 2007-December 2008. Cohort 2 presented between January 2013 and December 2014. Data were separated into those with POCUS vs. without ultrasound (NUS). Primary endpoint was POCUS utilization. Secondary endpoints were successful aspiration, otolaryngology (ear, nose, and throat [ENT]) consultation, computed tomography (CT) imaging, unscheduled return visits, and length of stay (LOS). The Fisher's exact and t-tests analyzed data.
RESULTS
Cohort 1 enrolled 48 patients, vs. 114 patients for cohort 2. Twelve patients in cohort 1 had a POCUS (25%) vs 89 in cohort 2 (78%) (p < 0.0001; odds ratio [OR] 0.09 (95% confidence interval [CI] 0.04-0.20). Emergency physician (EP) successful aspiration: 89.1% POCUS vs. 24.5% NUS (p < 0.0001; OR 25 [95% CI 10-59]). Combined EP/ENT successful aspiration: 99.0% POCUS vs. 80.3% NUS (p < 0.0001; OR 24 [95% CI 3-193]). ENT consultation:12.9% POCUS vs. 65.6% NUS (p < 0.0001; OR 0.07 [95% CI 0.03-0.17]). CT usage: 23.8% POCUS vs. 37.7% NUS (p = 0.07; OR 0.51 [95% CI 0.25-1.02]). Return visits: 3.96% POCUS vs. 18.0% NUS (p = 0.004; OR 0.18 [95% CI 0.05-0.61]).
CONCLUSION
POCUS use has increased for PTA treatment, improves aspiration, and decreases consultations, CTs, return visits, and LOS.",2020,"Return visits: 3.96% POCUS vs. 18.0% NUS (p = 0.004; OR 0.18 [95% CI 0.05-0.61]).
","['Cohort 1 presented to the emergency department (ED) January 2007-December 2008', 'peritonsillar abscess (PTA', 'Cohort 2 presented between January 2013 and December 2014', 'Cohort 1 enrolled 48 patients, vs. 114 patients for cohort 2', 'adult patients diagnosed with PTA']","['POCUS vs. without ultrasound (NUS', 'care ultrasound (POCUS']","['consultations, CTs, return visits, and LOS', 'successful aspiration, otolaryngology (ear, nose, and throat [ENT]) consultation, computed tomography (CT) imaging, unscheduled return visits, and length of stay (LOS', 'POCUS utilization']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0031157', 'cui_str': 'Peritonsillar abscess'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.221001,"Return visits: 3.96% POCUS vs. 18.0% NUS (p = 0.004; OR 0.18 [95% CI 0.05-0.61]).
","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Gibbons', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Costantino', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.06.030']
1802,32827348,"Double-blind, placebo-controlled study of lurasidone monotherapy for the treatment of bipolar I depression.","AIM
Previous studies conducted primarily in the USA and Europe have demonstrated the efficacy and safety of lurasidone 20-120 mg/day for the treatment of bipolar I depression. The aim of the current study was to evaluate the efficacy and safety of lurasidone monotherapy for the treatment of bipolar I depression among patients from diverse ethnic backgrounds, including those from Japan.
METHODS
Patients were randomly assigned to double-blind treatment for 6 weeks with lurasidone, 20-60 mg/day (n = 184) or 80-120 mg/day (n = 169), or placebo (n = 172). The primary end-point was change from baseline to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS).
RESULTS
Lurasidone treatment significantly reduced mean MADRS total scores from baseline to Week 6 for the 20-60-mg/day group (-13.6; adjusted P = 0.007; effect size = 0.33), but not for the 80-120-mg/day group (-12.6; adjusted P = 0.057; effect size = 0.22) compared with placebo (-10.6). Treatment with lurasidone 20-60 mg/day also improved MADRS response rates, functional impairment, and anxiety symptoms. The most common adverse events associated with lurasidone were akathisia and nausea. Lurasidone treatments were associated with minimal changes in weight, lipids, and measures of glycemic control.
CONCLUSION
Monotherapy with once daily doses of lurasidone 20-60 mg, but not 80-120 mg, significantly reduced depressive symptoms and improved functioning in patients with bipolar I depression. Results overall were consistent with previous studies, suggesting that lurasidone 20-60 mg/day is effective and safe in diverse ethnic populations, including Japanese.",2020,"RESULTS
Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","['patients with bipolar I depression', 'bipolar I depression among patients from diverse ethnic backgrounds including those from Japan', 'Patients']","['lurasidone', 'Placebo', 'Monotherapy', 'lurasidone monotherapy', 'Lurasidone Monotherapy', 'placebo']","['Montgomery Åsberg Depression Rating Scale (MADRS', 'depressive symptoms', 'weight or metabolic parameters', 'efficacy and safety', 'akathisia and nausea', 'mean MADRS total scores', 'MADRS response rates, functional impairment, and anxiety symptoms', 'body weight, lipids, and measures of glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.15438,"RESULTS
Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","[{'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Psychiatry, Juntendo University, Tokyo, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': 'Institute of CNS Pharmacology, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Miyajima', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Watabe', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Fujimori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Masuda', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Japan Depression Center, Tokyo, Japan.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Bipolar and Depressive Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Spain.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13137']
1803,32824040,Interactive Low Back Pain Intervention Module Based on the Back School Program: A Cluster-Randomized Experimental Study Evaluating Its Effectiveness among Nurses in Public Hospitals.,"The prevalence of low back pain (LBP) among nurses is high. The main aim of this study was to evaluate the effectiveness of an interactive LBP module based on the Back School Program in improving Oswestry Disability Scores (ODSs) among nurses in government hospitals in Penang, Malaysia. A cluster-randomized experimental study was conducted within four public hospitals. These hospitals were randomized to intervention and control groups. A total of 284 nurses from the selected hospitals were randomly selected (142 in each group). An interactive LBP intervention module based on the Back School Program was designed and prescribed. Both the intervention and control groups were assessed using the Oswestry Disability Questionnaire at baseline and at the end of the third and sixth weeks. Out of 284 participants, 281 completed this study. A between-group comparison revealed that ODSs were significantly lower in the intervention group than in the control group at the ends of the third ( p = 0.006) and sixth weeks ( p < 0.001). Within-group changes revealed a significant reduction in ODSs within the intervention group from baseline to the third ( p < 0.001) and sixth weeks ( p < 0.001) of the intervention. This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.",2020,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","['Back School Program', 'nurses in government hospitals in Penang, Malaysia', 'four public hospitals', '284 nurses from the selected hospitals were randomly selected (142 in each group', '284 participants, 281 completed this study', 'Nurses in Public Hospitals']","['Interactive Low Back Pain Intervention Module', 'interactive LBP module based on the Back School Program']","['Oswestry Disability Scores (ODSs', 'Oswestry Disability Questionnaire', 'ODSs', 'low back pain (LBP']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",284.0,0.0391314,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","[{'ForeName': 'Mohd Ismail', 'Initials': 'MI', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Izani Uzair', 'Initials': 'IU', 'LastName': 'Zubair', 'Affiliation': 'Penang Health State Department, 33 Pengkalan Weld, George Town, Penang 10300, Malaysia.'}, {'ForeName': 'Mohd Nazri', 'Initials': 'MN', 'LastName': 'Shafei', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Mohd Izmi', 'Initials': 'MI', 'LastName': 'Ahmad', 'Affiliation': 'Hospital Pulau Pinang, Jalan Residensi, George Town, Penang 10990, Malaysia.'}, {'ForeName': 'Najib Majdi', 'Initials': 'NM', 'LastName': 'Yaacob', 'Affiliation': 'Units of Biostatistics and Research Methodology, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165916']
1804,32827709,Acute effect of inspiratory resistive loading on sprint interval exercise performance in team-sport athletes.,"This study examined acute effects of inspiratory resistive loading (IRL) during rest intervals on sprint interval exercise (SIE) performance. In a randomized crossover design, nine collegiate basketball players performed IRL (15 cmH 2 O) or passive recovery (CON) at 5-min rest intervals during and immediately after 6 sets of a 30-s SIE test. Performance, muscular oxygenation of vastus lateralis, blood lactate and pH were measured at each condition. Blood lactate at 5-min (-20.5 %) and 20-min (-21.3 %) after SIE were significantly lower in IRL than in CON. The pH at 5-min after SIE was significantly higher in IRL than in CON (+0.8 %, p < 0.05). However, the total work in IRL was significantly lower than in CON (-2.7 %, p < 0.05). Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5 %, p < 0.05). The IRL could attenuate exercise-induced metabolic acidosis; however, the decreased blood flow at rest intervals might increase the physical challenge in SIE.",2020,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p < 0.05).",['team-sport athletes'],"['inspiratory resistive loading (IRL', 'CON', 'inspiratory resistive loading', 'IRL (15\u2009cmH 2 O) or passive recovery (CON']","['sprint interval exercise performance', 'Blood lactate', 'IRL', 'sprint interval exercise (SIE) performance', 'total hemoglobin at rest intervals in IRL', 'blood flow', 'Performance, muscular oxygenation of vastus lateralis, blood lactate and pH', 'total work in IRL']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",,0.0174742,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p < 0.05).","[{'ForeName': 'Ching-Feng', 'Initials': 'CF', 'LastName': 'Cheng', 'Affiliation': 'Department of Athletic Performance, National Taiwan Normal University, Taipei, Taiwan; Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan. Electronic address: andescheng@ntnu.edu.tw.'}, {'ForeName': 'Wei-Chieh', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Graduate Institute of Sports Training, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Sports Performance Lab, National Taiwan Normal University, Taipei, Taiwan; Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Wei', 'Initials': 'TW', 'LastName': 'Chen', 'Affiliation': 'Physical Education Office, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103531']
1805,32766779,Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial.,"OBJECTIVE
No study to our knowledge has investigated the effects longer than 1 year of manual therapy in carpal tunnel syndrome (CTS). The purpose of this study was to investigate the effects of manual therapy versus surgery at 4-year follow-up and to compare the post-study surgery rate in CTS.
METHODS
This randomized controlled trial was conducted in a tertiary public hospital and included 120 women with CTS who were randomly allocated to manual therapy or surgery. The participants received 3 sessions of physical therapy, including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home. Primary outcome was pain intensity (mean and the worst pain). Secondary outcomes included functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale. Outcomes for this analysis were assessed at baseline, 1 year, and 4 years. The rate of surgical intervention received by each group was assessed throughout the study.
RESULTS
At 4 years, 97 (81%) women completed the study. Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1) and 4 years (mean pain: MD = 0.1, 95% CI = -0.2 to 0.4; worst pain: MD = 0.2, 95% CI = -0.8 to 1.2; function: MD = 0.1, 95% CI = -0.1 to 0.3; symptom severity: MD = 0.2, 95% CI = -0.2 to 0.6). Self-perceived improvement was also similar in both groups. No between-group differences (15% physical therapy vs 13% surgery) in surgery rate were observed during the 4 years.
CONCLUSIONS
In the long term, manual therapy, including desensitization maneuvers of the central nervous system, resulted in similar outcomes and similar surgery rates compared with surgery in women with CTS. Both interventions were combined with a tendon/nerve gliding exercise program at home.
IMPACT
This is the first study to our knowledge to report clinical outcomes and surgical rates during a 4-year follow-up and will inform decisions regarding surgical versus conservative management of CTS.
LAY SUMMARY
Women with CTS may receive similar benefit from a more conservative treatment-manual therapy-as they would from surgery.",2020,"Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1), and 4 years (mean pain: MD = 0.1, 95% CI = ","['carpal tunnel syndrome CTS', 'carpal tunnel syndrome (CTS', 'At 4\xa0years, 97 (81%) women completed the study', 'Carpal Tunnel Syndrome', 'tertiary public hospital and included 120 women with CTS']","['tendon/nerve gliding exercise program at home', 'manual therapy', 'physical therapy including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home', 'manual therapy or surgery', 'Manual Therapy Versus Surgery']","['surgery rate', 'pain intensity (mean and the worst pain', 'rate of surgical intervention', 'functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale', 'surgery rates']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0178702', 'cui_str': 'Desensitization therapy'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0196576', 'cui_str': 'Decompression of median nerve'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",120.0,0.131334,"Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1), and 4 years (mean pain: MD = 0.1, 95% CI = ","[{'ForeName': 'César', 'Initials': 'C', 'LastName': 'Fernández-de-Las-Peñas', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Avenida de Atenas s/n, Alcorcón, Madrid, Spain 28922, and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Arias-Buría', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Cleland', 'Affiliation': 'Doctor of Physical Therapy Program, Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Pareja', 'Affiliation': 'Department of Neurology and Neurophysiology, Hospital Universitario Fundación, Alcorcón, Madrid, Spain.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Plaza-Manzano', 'Affiliation': 'Department of Radiology, Rehabilitation and Physiotherapy, Universidad Complutense de Madrid, Madrid, Spain; and Instituto de Investigación Sanitaria del Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Ortega-Santiago', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos and Cátedra Institucional en Docencia, Clínica e Investigación en Fisioterapia Terapia Manual, Punción Seca y Ejercicio Terapéutico, Universidad Rey Juan Carlos.'}]",Physical therapy,['10.1093/ptj/pzaa150']
1806,32769754,Remote corneal suturing wet lab: microsurgical education during the COVID-19 pandemic.,"PURPOSE
To study the feasibility and efficacy of a new remote wet lab for microsurgical education using a corneal suturing task.
SETTING
Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.
DESIGN
Prospective randomized controlled study.
METHODS
Ten ophthalmology residents were stratified by postgraduate year and randomized to perform a corneal suturing task consisting of placing the 4 cardinal sutures for a penetrating keratoplasty in porcine eyes with or without remote ophthalmology attending feedback. Subsequently, both groups repeated the same task without remote feedback to test whether initial remote feedback affected subsequent performance. Finally, the group without feedback was crossed over to repeat the same corneal suturing task with remote feedback. The effectiveness of the remote wet lab was assessed subjectively by survey and objectively by grading each suture pass.
RESULTS
Resident-reported comfort with corneal suturing improved significantly after the remote wet lab for all residents. Residents and attendings rated the remote wet lab as equally or more effective compared with previous in-person wet labs and overall effective in corneal suturing. Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale. Objective corneal suturing performance was similar for both groups.
CONCLUSIONS
The remote wet lab was feasible and effective for training ophthalmology residents in corneal suturing. This represents a new social distancing compliant platform for microsurgical education during the COVID-19 pandemic.",2020,Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale.,"['Ten ophthalmology residents', 'Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA']","['Remote corneal suturing wet lab', 'corneal suturing task consisting of placing the 4 cardinal sutures for a penetrating keratoplasty in porcine eyes with or without remote ophthalmology attending feedback', 'novel remote wet lab for microsurgical education']","['comfort with corneal suturing', 'Objective corneal suturing performance']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0326926', 'cui_str': 'Cardinalis cardinalis'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0022592', 'cui_str': 'Penetrating keratoplasty'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0200271,Attendings rated the remote wet lab as effective in multiple domains of microsurgical education using a modified microsurgical global rating scale.,"[{'ForeName': 'Neel D', 'Initials': 'ND', 'LastName': 'Pasricha', 'Affiliation': 'From the Department of Ophthalmology (Pasricha, Haq, Chan, Redd, Seitzman, Parikh, Kim, Schallhorn, Ramanathan), School of Medicine (Ahmad), and Francis I. Proctor Foundation (Redd, Seitzman, Schallhorn), University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Haq', 'Affiliation': ''}, {'ForeName': 'Tessnim R', 'Initials': 'TR', 'LastName': 'Ahmad', 'Affiliation': ''}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Travis K', 'Initials': 'TK', 'LastName': 'Redd', 'Affiliation': ''}, {'ForeName': 'Gerami D', 'Initials': 'GD', 'LastName': 'Seitzman', 'Affiliation': ''}, {'ForeName': 'Neeti', 'Initials': 'N', 'LastName': 'Parikh', 'Affiliation': ''}, {'ForeName': 'Tyson N', 'Initials': 'TN', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Schallhorn', 'Affiliation': ''}, {'ForeName': 'Saras', 'Initials': 'S', 'LastName': 'Ramanathan', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000374']
1807,32769757,"Effect of the neurokinin 3 receptor antagonist fezolinetant on patient-reported outcomes in postmenopausal women with vasomotor symptoms: results of a randomized, placebo-controlled, double-blind, dose-ranging study (VESTA).","OBJECTIVE
In the primary analysis of the phase 2b VESTA study, oral fezolinetant reduced frequency and severity of menopausal vasomotor symptoms (VMS) compared with placebo. This secondary analysis evaluates effects of fezolinetant on responder rates and patient-reported outcomes (PROs).
METHODS
In this 12-week, double-blind study, postmenopausal women with moderate/severe VMS were randomized to fezolinetant 15, 30, 60, or 90 mg BID or 30, 60, or 120 mg QD or placebo. Proportion of responders was based on reductions in VMS from daily diary records. P values for comparisons between active treatment and placebo were calculated using logistic regression. Changes from baseline in PROs (Menopause-Specific Quality of Life questionnaire, Hot Flash-Related Daily Interference Scale, Greene Climacteric Scale) were conducted using a mixed model for repeated measurements and compared post hoc with published minimally important differences (MIDs).
RESULTS
Of 356 women randomized, 352 were treated and analyzed. A greater proportion of women receiving fezolinetant versus placebo met definitions of response at week 12. For all doses, mean changes from baseline in Menopause-Specific Quality of Life questionnaire VMS scores exceeded the MID (1.2) at weeks 4 (placebo: -1.8; fezolinetant: range, -1.9 to -3.6) and 12 (placebo: -2.3; fezolinetant: range, -2.9 to -4.4). Mean changes in Hot Flash-Related Daily Interference Scale at weeks 4 (placebo: -2.2; fezolinetant: range, -2.5 to -3.8) and 12 (placebo: -2.9; fezolinetant: range, -3.3 to -4.3) exceeded the MID (1.76). Greene Climacteric Scale-VMS domain scores improved for most fezolinetant doses versus placebo (week 4, placebo: -1.7; fezolinetant: range, -2.1 to -3.3; week 12, placebo: -2.1; fezolinetant: range, -2.7 to -3.6).
CONCLUSIONS
Oral fezolinetant was associated with higher responder rates than placebo and larger improvements in QoL and other PRO measures, including a reduction in VMS-related interference with daily life.",2020,"Greene Climacteric Scale-VMS domain scores improved for most fezolinetant doses versus placebo (week 4, placebo: -1.7; fezolinetant: range, -2.1 to -3.3; week 12, placebo: -2.1; fezolinetant: range, -2.7 to -3.6).
","['postmenopausal women with moderate/severe VMS', '356 women randomized, 352 were treated and analyzed', 'postmenopausal women with vasomotor symptoms']","['fezolinetant', 'neurokinin 3 receptor antagonist fezolinetant', 'placebo']","['responder rates and patient-reported outcomes (PROs', 'Menopause-Specific Quality of Life questionnaire VMS scores', 'responder rates', 'Mean changes in Hot Flash-Related Daily Interference Scale', 'frequency and severity of menopausal vasomotor symptoms (VMS', 'Greene Climacteric Scale-VMS domain scores', 'PROs (Menopause-Specific Quality of Life questionnaire, Hot Flash-Related Daily Interference Scale, Greene Climacteric Scale']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C4547455', 'cui_str': 'fezolinetant'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0600142', 'cui_str': 'Menopausal flushing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",356.0,0.517058,"Greene Climacteric Scale-VMS domain scores improved for most fezolinetant doses versus placebo (week 4, placebo: -1.7; fezolinetant: range, -2.1 to -3.3; week 12, placebo: -2.1; fezolinetant: range, -2.7 to -3.6).
","[{'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Waldbaum', 'Affiliation': ""Downtown Women's Healthcare, Denver, CO.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Lederman', 'Affiliation': 'Altus Research, Lake Worth, FL.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kroll', 'Affiliation': ""Seattle Women's: Health, Research, Gynecology, Seattle, WA.""}, {'ForeName': 'Graeme L', 'Initials': 'GL', 'LastName': 'Fraser', 'Affiliation': 'OGEDA SA, subsidiary of Astellas Pharma, Inc., Gosselies, Belgium.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lademacher', 'Affiliation': 'Astellas Pharma US, Inc., Northbrook, IL.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Skillern', 'Affiliation': 'Astellas Pharma Europe Ltd, Chertsey, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Astellas Pharma US, Inc., Northbrook, IL.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Ramael', 'Affiliation': 'OGEDA SA, subsidiary of Astellas Pharma, Inc., Gosselies, Belgium.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001621']
1808,32770859,Randomised clinical study: oral aspirin 325 mg daily vs placebo alters gut microbial composition and bacterial taxa associated with colorectal cancer risk.,"BACKGROUND
Aspirin is associated with decreased risk of colorectal cancer (CRC), potentially by modulating the gut microbiome.
AIMS
To evaluate the effect of aspirin on the gut microbiome in a double-blinded, randomised placebo-controlled pilot trial.
METHODS
Healthy volunteers aged 50-75 received a standard dose of aspirin (325 mg, N = 30) or placebo (N = 20) once daily for 6 weeks and provided stool samples every 3 weeks for 12 weeks. Serial measurements of gut microbial community composition and bacterial abundance were derived from 16S rRNA sequences. Linear discriminant analysis of effect size (LEfSe) was tested for between-arm differences in bacterial abundance. Mixed-effect regression with binomial distribution estimated the effect of aspirin use on changes in the relative abundance of individual bacterial taxa via an interaction term (treatment × time).
RESULTS
Over the study period, there were differences in microbial composition in the aspirin vs placebo arm. After treatment, four taxa were differentially abundant across arms: Prevotella, Veillonella, Clostridium XlVa and Clostridium XVIII clusters. Of pre-specified bacteria associated with CRC (n = 8) or aspirin intake (n = 4) in published studies, interactions were significant for four taxa, suggesting relative increases in Akkermansia, Prevotella and Ruminococcaceae and relative decreases in Parabacteroides, Bacteroides and Dorea in the aspirin vs placebo arm.
CONCLUSION
Compared to placebo, aspirin intake influenced several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea) in a direction consistent with a priori hypothesis based on their association with CRC. This suggests that aspirin may influence CRC development through an effect on the gut microbiome. The findings need replication in a larger trial.",2020,"Compared to placebo, aspirin intake influenced several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea) in a direction consistent with a priori hypothesis based on their association with CRC.",['Healthy volunteers aged 50-75 received a'],"['placebo, aspirin', 'aspirin intake ', 'aspirin 325\xa0mg daily vs placebo', 'Aspirin', 'aspirin', 'standard dose of aspirin', 'placebo']","['Akkermansia, Prevotella and Ruminococcaceae and relative decreases in Parabacteroides, Bacteroides and Dorea', 'microbial composition and bacterial taxa associated with colorectal cancer risk', 'several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea', 'microbial composition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0992015', 'cui_str': 'Aspirin 325 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1927848', 'cui_str': 'Parabacteroides'}, {'cui': 'C1212549', 'cui_str': 'Dorea'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}]",,0.618793,"Compared to placebo, aspirin intake influenced several microbial taxa (Ruminococcaceae, Clostridium XlVa, Parabacteroides and Dorea) in a direction consistent with a priori hypothesis based on their association with CRC.","[{'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Prizment', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Staley', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Guillaume C', 'Initials': 'GC', 'LastName': 'Onyeaghala', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Sithara', 'Initials': 'S', 'LastName': 'Vivek', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Thyagarajan', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Straka', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Demmer', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Meyer', 'Affiliation': 'Chapel Hill, NC, USA.'}, {'ForeName': 'Aasma', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Sadowsky', 'Affiliation': 'Minneapolis, MN, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Church', 'Affiliation': 'Minneapolis, MN, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16013']
1809,32771321,Time to Loss of Preoxygenation in Emergency Department Patients.,"BACKGROUND
In patients requiring emergency rapid sequence intubation (RSI), 100% oxygen is often delivered for preoxygenation to replace alveolar nitrogen with oxygen. Sometimes, however, preoxygenation devices are prematurely removed from the patient prior to the onset of apnea, which can lead to rapid loss of preoxygenation.
OBJECTIVE
We sought to determine the elapsed time, on average, between removing the oxygen source and the loss of preoxygenation among non-critically ill patients in the emergency department (ED).
METHODS
We conducted a prospective, crossover study of non-critically ill patients in the ED. Each patient received two identical preoxygenation trials for 4 min using a non-rebreather mask with oxygen flow at flush rate and a nasal cannula with oxygen flow at 10 L/min. After each preoxygenation trial, patients underwent two trials in random order while continuing spontaneous breathing: 1) removal of both oxygen sources and 2) removal of non-rebreather mask with nasal cannula left in place. We defined loss of preoxygenation as an end-tidal oxygen (exhaled oxygen percentage; EtO 2 ) value < 70%. We measured EtO 2 breath by breath until loss of preoxygenation occurred.
RESULTS
We enrolled 42 patients, median age was 43 years (interquartile range [IQR] 30 to 54 years) and 72% were male. Median time to loss of preoxygenation was 20 s (IQR 17-25 s, 4.5 breaths) when all oxygen devices were removed, and 39 s (IQR 21-56 s, 8 breaths) when the nasal cannula was left in place.
CONCLUSIONS
In this population of non-critically ill ED patients, most had loss of preoxygenation after 5 breaths if all oxygen devices were removed, and after 8 breaths if a nasal cannula was left in place. These data suggest that during ED RSI, preoxygenation devices should be left in place until the patient is completely apneic.",2020,"Median time to loss of preoxygenation was 20 s (IQR 17-25 s, 4.5 breaths) when all oxygen devices were removed, and 39 s (IQR 21-56 s, 8 breaths) when the nasal cannula was left in place.
","['We enrolled 42 patients, median age was 43\xa0years (interquartile range [IQR] 30 to 54\xa0years) and 72% were male', 'non-critically ill patients in the ED', 'non-critically ill patients in the emergency department (ED', 'patients requiring emergency rapid sequence intubation (RSI', 'Emergency Department Patients']","['oxygen sources and 2) removal of non-rebreather mask with nasal cannula left in place', 'non-rebreather mask with oxygen flow at flush rate and a nasal cannula with oxygen flow']","['Median time to loss of preoxygenation', 'EtO 2 breath by breath until loss of preoxygenation occurred']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C5200706', 'cui_str': 'Rapid Sequence Intubation'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1960093', 'cui_str': 'Nonrebreather oxygen mask'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0005874', 'cui_str': 'Blushing'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation'}, {'cui': 'C0218234', 'cui_str': 'CBFA2T1 protein, human'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",42.0,0.313091,"Median time to loss of preoxygenation was 20 s (IQR 17-25 s, 4.5 breaths) when all oxygen devices were removed, and 39 s (IQR 21-56 s, 8 breaths) when the nasal cannula was left in place.
","[{'ForeName': 'Jarrod', 'Initials': 'J', 'LastName': 'Mosier', 'Affiliation': 'Department of Emergency Medicine and Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep, University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Reardon', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Paige A', 'Initials': 'PA', 'LastName': 'DeVries', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Stang', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Nelsen', 'Affiliation': 'Albany Medical College, Albany, New York.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Prekker', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota; Division of Pulmonary/Critical Care, Department of Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Driver', 'Affiliation': 'Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, Minnesota.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.06.064']
1810,32775959,The Impact of a Sustained Cognitive Engagement Intervention on Cognitive Variability: The Synapse Project.,"Background
Interest in maintaining one's cognitive ability and quality of life through older adulthood has greatly increased in recent years. However, research examining the effectiveness of cognitive engagement interventions on older adults is mixed and the mechanisms behind improving cognition in older age are unknown. It is possible that traditional measures of cognitive outcomes, such as average reaction time, may overlook potential benefits due to a lack of sensitivity in these measures. One alternative metric is intraindividual variability (IIV) in response speed (short-term variations in performance on reaction time tasks), which reflects fluctuations in attention and is a sensitive behavioral measure of neurological integrity that is predictive of future cognitive decline and impairment.
Objective
The current study aimed to investigate whether IIV was improved in older adults through productive cognitive engagement (i.e., acquisition of new skills) in comparison to receptive engagement (activities that rely upon existing knowledge).
Methods
Participants were 173 typically aging adults aged 60-90 years who were recruited to the Synapse Project and randomly allocated to a productive engagement activity (learning to quilt and/or conduct digital photography) or receptive engagement activity (socializing, or placebo cognitive tasks such as completing crosswords). Participants completed three flanker tasks at baseline and after completing the 14-week intervention program. IIV was calculated as the trial-to-trial variability in responding to congruent and incongruent trials in each task.
Results
Neither traditional intent-to-treat nor complier average causal effect modeling analyses showed any significant improvements in IIV for either intervention group. Further, Bayesian analyses showed that there was moderate evidence in favor of the null hypothesis.
Conclusion
An intensive cognitive activity intervention did not result in a reduction in IIV. We suggest that intervention programs may need to specifically engage cognitive domains associated with IIV (i.e., attention, executive control) for improvements to be observed. Additionally, other design factors such as using a longer duration and/or applying the intervention to atypically aging groups, such as those with mild cognitive impairment, may increase the likelihood of significantly reducing IIV via an intervention.",2019,Neither traditional intent-to-treat nor complier average causal effect modeling analyses showed any significant improvements in IIV for either intervention group.,"['older adults', 'Methods\n\n\nParticipants were 173 typically aging adults aged 60-90 years who were recruited to the Synapse Project']","['Sustained Cognitive Engagement Intervention', 'intensive cognitive activity intervention', 'productive engagement activity (learning to quilt and/or conduct digital photography) or receptive engagement activity (socializing, or placebo cognitive tasks such as completing crosswords', 'cognitive engagement interventions']",['Cognitive Variability'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039062', 'cui_str': 'Synapse structure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C4044304', 'cui_str': 'Quilt'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",[],173.0,0.0423925,Neither traditional intent-to-treat nor complier average causal effect modeling analyses showed any significant improvements in IIV for either intervention group.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Brydges', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, USA.'}, {'ForeName': 'Allison A M', 'Initials': 'AAM', 'LastName': 'Bielak', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, USA.'}]",Journal of cognitive enhancement : towards the integration of theory and practice,['10.1007/s41465-019-00140-9']
1811,32777247,Does Repositioning of Temporomandibular Joint Disc With Bone Anchors Provide Better Clinical Outcomes Than Conventional Disc Plication Procedures for Anterior Disc Displacements Without Reduction in Patients Refractory to Nonsurgical Treatments?,"PURPOSE
Although open temporomandibular joint arthroplasty with discopexy is a common treatment for patients with anterior disc displacements without reduction (ADDWo) unresponsive to medical management, there are no studies comparing disc repositioning with bone anchors and conventional discopexy procedure. The purpose of the study was to compare the efficacy between disc repositioning with bone anchors and the conventional discopexy procedure for ADDWo of temporomandibular joint refractory to medical management.
PATIENTS AND METHODS
A randomized controlled trial was conducted in patients with ADDWo. The primary objective was to compare the improvement in mouth opening (primary outcome variable) between the 2 treatment (primary predictor variable) groups-disc repositioning with bone anchors versus conventional disc plication. Secondary outcome variables were pain measured by visual analog scale, lateral excursions, and position of the disc evaluated by magnetic resonance imaging (MRI). Other variables of interest were age, gender, and duration of symptoms. The parameters were evaluated at preoperative, postoperative day 1, and 1-, 6-, and 12-month postoperative period. Categorical variables were compared with χ 2 test and continuous variables with analysis of variance and adjusted for multiple comparisons with Bonferroni test.
RESULTS
The study sample comprised 14 patients (7 in each group) with MRI-proven ADDWo. Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05). The reduction in visual analog scale also showed statistically significant difference with better pain reduction achieved with bone anchor (4.57 ± 1.61 vs 3.28 ± 0.75; P < .05). There was no statistically significant difference in lateral excursions and postoperative position of the disc evaluated by MRI between the groups at the 12-month follow-up period.
CONCLUSIONS
Disc repositioning with bone anchors provides better clinical outcomes in terms of maximal mouth opening and pain scores compared with conventional disc plication.",2020,"Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05).","['14 patients (7 in each group) with MRI-proven ADDWo', 'patients with anterior disc displacements without reduction (ADDWo) unresponsive to medical management', 'patients with ADDWo']","['discopexy', 'Conventional Disc Plication Procedures', 'disc repositioning with bone anchors and the conventional discopexy procedure', 'Disc repositioning with bone anchors']","['pain scores', 'Anterior Disc Displacements', 'improvement of mouth opening', 'pain reduction', 'Temporomandibular Joint Disc', 'pain measured by visual analog scale, lateral excursions, and position of the disc evaluated by magnetic resonance imaging (MRI', 'improvement in mouth opening', 'lateral excursions and postoperative position of the disc evaluated by MRI', 'visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376491', 'cui_str': 'Structure of articular disc of temporomandibular joint'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",14.0,0.0853924,"Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05).","[{'ForeName': 'Jithin Sasikumar', 'Initials': 'JS', 'LastName': 'Puthukkudiyil', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India. Electronic address: dr_ongkila@rediffmail.com.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Krushna', 'Initials': 'K', 'LastName': 'Bhatt', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Ashu Seith', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Professor, Department of Radio Diagnosis, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.07.013']
1812,32772733,"Serum Perfluoroalkyl Substances, Vaccine Responses, and Morbidity in a Cohort of Guinea-Bissau Children.","BACKGROUND
Perfluoroalkyl substances (PFAS) are a group of widely used persistent chemicals with suspected immunotoxic effects.
OBJECTIVES
The present study aimed to examine the association between infant PFAS exposure and antibody responses to measles vaccination as well as morbidity in a low-income country.
METHODS
In a randomized controlled trial, children from Guinea-Bissau, West Africa, were followed from inclusion (4-7 months of age) through 2 years of age. Half the children received two measles vaccinations (at inclusion and at 9 months of age), and the other half received only one (at 9 months of age). In a subset of 237 children, six PFAS were quantified in serum at inclusion, and measles antibody concentrations were assessed at inclusion and at approximately 9 months and 2 years of age. At inclusion and at the 9-month visit, mothers were interviewed about infant morbidity.
RESULTS
All but one child had detectable serum concentrations of all six PFAS, although levels were lower than seen elsewhere. A doubling in perfluorooctane sulfonic acid (PFOS) and perfluorodecanoic acid (PFDA) were associated with 21% (95% CI: 2, 37%) and 25% (95% CI: 1, 43%), respectively, lower measles antibody concentrations at the 9-month visit among the children who had received a measles vaccine at inclusion. Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
DISCUSSION
The present study documents that PFAS exposure has reached West Africa and that infants show PFAS-associated increases in morbidity and decreases in measles-specific antibody concentrations before and after vaccination. These findings support the evidence on PFAS immunotoxicity at comparatively low serum concentrations. https://doi.org/10.1289/EHP6517.",2020,"Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
","['children from Guinea-Bissau, West Africa, were followed from inclusion (4-7 months of age) through 2 years of age']","['Perfluoroalkyl substances (PFAS', 'https://doi.org/10.1289/EHP6517']","['Elevated serum PFAS concentrations', 'PFAS immunotoxicity', 'morbidity', 'Serum Perfluoroalkyl Substances, Vaccine Responses, and Morbidity', 'perfluorooctane sulfonic acid (PFOS) and perfluorodecanoic acid (PFDA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018387', 'cui_str': 'Guinea-Bissau'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0457929', 'cui_str': 'Substance concentration'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctane sulfonic acid'}, {'cui': 'C0070396', 'cui_str': 'perfluorodecanoic acid'}]",237.0,0.111341,"Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
","[{'ForeName': 'Clara Amalie Gade', 'Initials': 'CAG', 'LastName': 'Timmermann', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kristoffer Jarlov', 'Initials': 'KJ', 'LastName': 'Jensen', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Nielsen', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Budtz-Jørgensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'van der Klis', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grandjean', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ane Bærent', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}]",Environmental health perspectives,['10.1289/EHP6517']
1813,32574418,Role of Terlipressin and Albumin for Hepatorenal Syndrome in Liver Transplantation.,"Hepatorenal syndrome (HRS) is one of the most ominous complications of portal hypertension in patients with decompensated cirrhosis and ascites. It is associated with very high mortality on the wait list. Liver transplantation (LT) is the most successful therapeutic option for patients with HRS. However, not all the LT candidates with HRS are able to receive a deceased donor allograft in a timely manner because it is a scarce resource and patients may need alternative best supportive treatment with systemic splanchnic vasoconstrictors and albumin as a bridge to transplant. The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide. More recently, the multicenter, randomized, placebo-controlled double-blind study to confirm efficacy and safety of terlipressin in subjects with hepatorenal syndrome type 1 (the CONFIRM study) trial demonstrated the efficacy of terlipressin and albumin in the reversal of HRS in a North American cohort. The aim of this article is to review the role of terlipressin and albumin in LT candidates with HRS in the United States.",2020,The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide.,"['Hepatorenal Syndrome in Liver Transplantation', 'subjects with hepatorenal syndrome type 1', 'patients with decompensated cirrhosis and ascites', 'patients with HRS']","['Liver transplantation (LT', 'terlipressin and albumin', 'terlipressin', 'Terlipressin and Albumin', 'placebo']",['Hepatorenal syndrome (HRS'],"[{'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}]","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0145185', 'cui_str': 'terlipressin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}]",,0.0877855,The combination of terlipressin and albumin is efficacious in the reversal of HRS and is used worldwide.,"[{'ForeName': 'Pratima', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Division of Gastroenterology and Hepatology, Michigan Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'University College London Institute for Liver and Digestive Health, London, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ganger', 'Affiliation': 'Division of Gastroenterology and Hepatology, Northwestern Medicine, Chicago, IL.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Grewal', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mount Sinai Health System, New York, NY.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Brown', 'Affiliation': 'Division of Gastroenterology and Hepatology, Weill Cornell Medical College, New York, NY.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25834']
1814,32783267,Effect of dentin and fiber post surface treatments with fumaric acid on the bonding ability of fiber posts.,"This study investigated the effects of fumaric acid on push-out bond strength when applied to dentin surfaces and fiber posts. The root canals of 60 mandibular premolar teeth were instrumented and obturated. After removing two thirds of filling material, teeth were prepared according to six randomized groups (n = 10/group) defined by two fiber post surface treatments (0.7% fumaric acid or 9% hydrofluoric acid) and three dentin conditioning treatments [control (no conditioning); 17% ethylenediamine tetraacetic acid (EDTA); or 0.7% fumaric acid]. After fiber post-cementation, three 1-mm thick discs were obtained from each tooth by transverse sectioning, and each disc underwent push-out bond strength testing. Data were analyzed with a one-way analyses of variance (anova) and t tests; p < .05 was considered statistically significant. Failure modes were determined by stereomicroscopy, and the surface characteristics of dentin and fiber posts were observed by scanning electron microscopy. Push-out bond strength was greater for the group in which the post surface treated with hydrofluoric acid and the dentin surface treated with fumaric acid than the nontreated dentin and hydrofluoric acid-treated post group (p < .05). There were no significant differences between other comparison pairs (p > .05). A combination of fumaric acid dentin conditioning and hydrofluoric acid fiber post treatment strengthened the bonding ability of fiber posts.",2020,A combination of fumaric acid dentin conditioning and hydrofluoric acid fiber post treatment strengthened the bonding ability of fiber posts.,"['60 mandibular premolar teeth', 'fiber posts']","['fumaric acid', 'fumaric acid or 9% hydrofluoric acid', 'hydrofluoric acid', 'dentin conditioning treatments [control (no conditioning); 17% ethylenediamine tetraacetic acid (EDTA); or 0.7% fumaric acid']",['Push-out bond strength'],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0060825', 'cui_str': 'fumaric acid'}, {'cui': 'C0020274', 'cui_str': 'Hydrofluoric Acid'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015091', 'cui_str': 'Ethylenediamine'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C4517474', 'cui_str': '0.7'}]","[{'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}]",,0.0162423,A combination of fumaric acid dentin conditioning and hydrofluoric acid fiber post treatment strengthened the bonding ability of fiber posts.,"[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saricam', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Arslan', 'Affiliation': 'Vocational School of Health Services, Kirikkale University, Kirikkale, Turkey.'}]",Microscopy research and technique,['10.1002/jemt.23562']
1815,32788052,Thiol/Disulfide Homeostasis in Patients With Erectile Dysfunction.,"BACKGROUND
Although there are no sufficient data on association between oxidative stress and erectile dysfunction (ED), numerous studies have reported that imbalance between the formation of reactive oxygen species and body's antioxidant defenses may play a role in the pathogenesis of ED.
AIM
The aim of this study was to determine and compare the oxidant and antioxidant status in patients with ED and healthy controls with a novel automated assay for thiol/disulphide homeostasis test.
METHODS
Our study included 123 patients with ED and 90 healthy individuals. ED was evaluated by asking questions 1-5 and 15 of the International Index of Erectile Function form. In this study, we used Erel and Neselioglu's thiol/disulfide homeostasis test, which is one of the novel methods that can measure both variables of the oxidative/antioxidative balance individually and collectively.
OUTCOMES
This method measured serum antioxidant (total thiol [toSH], native thiol [SH]) and oxidant (disulfide [SS]) levels. The statistical comparisons were performed between patients with ED (ED+ group) and without ED (ED- group) first and then within the ED+ group. After toSH, SH, and SS levels were determined; SS/toSH%, SS/SH%, and SH/toSH% levels were analyzed separately and compared statistically.
RESULTS
We found a significant difference between ED- and ED+ groups in terms of toSH, SH, SS/toSH%, and SS/SH% ratios. SS parameters were increased in patients with ED, but there was no significant difference in terms of SS and SH/toSH% values.
CLINICAL IMPLICATIONS
Clarification of the factors involved in the etiology of ED such as oxidative/antioxidative balance may open new grounds in the early diagnosis and treatment of the disease.
STRENGTHS & LIMITATIONS
It is a prospective, randomized clinical study with the use of a novel, reliable, and fully automated technique. The limitations of the study are use of a subjective tool such as the International Index of Erectile Function, obtaining blood samples from the peripheral vein instead of penile cavernosal tissue, and relatively small sample size.
CONCLUSION
The results of this study showed that thiol/disulfide homeostasis is altered in ED, and this imbalance may be a factor in its pathophysiology. We determined that as ED gets more severe, toSH and SH parameters decrease, whereas SS parameter increases. Micoogullari U, Karatas OF, Kisa E, et al. Thiol/Disulfide Homeostasis in Patients With Erectile Dysfunction. J Sex Med 2020;17:1934-1941.",2020,"SS parameters were increased in patients with ED, but there was no significant difference in terms of SS and SH/toSH% values.
","['123 patients with ED and 90 healthy individuals', 'patients with ED and healthy controls with a novel automated assay for thiol/disulphide homeostasis test', 'Patients With Erectile Dysfunction']",[],"['SS parameters', 'oxidant and antioxidant status', 'SS/toSH%, SS/SH%, and SH/toSH% levels', 'SH, and SS levels', 'Micoogullari U, Karatas OF, Kisa E, et', 'toSH, SH, SS/toSH%, and SS/SH% ratios', 'SS and SH/toSH% values', 'serum antioxidant (total thiol [toSH], native thiol [SH]) and oxidant (disulfide [SS]) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",[],"[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0012771', 'cui_str': 'Disulfides'}]",123.0,0.0161754,"SS parameters were increased in patients with ED, but there was no significant difference in terms of SS and SH/toSH% values.
","[{'ForeName': 'Uygar', 'Initials': 'U', 'LastName': 'Micoogullari', 'Affiliation': 'Department of Urology, Tepecik Education and Research Hospital, University of Health Sciences, İzmir, Turkey. Electronic address: uygarmico@hotmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Karatas', 'Affiliation': 'Deparment of Urology, Gulhane Medical School, Health Sciences University, Ankara, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Kisa', 'Affiliation': 'Department of Urology, Tepecik Education and Research Hospital, University of Health Sciences, İzmir, Turkey.'}, {'ForeName': 'Mehmet Zeynel', 'Initials': 'MZ', 'LastName': 'Keskin', 'Affiliation': 'Department of Urology, Tepecik Education and Research Hospital, University of Health Sciences, İzmir, Turkey.'}, {'ForeName': 'Ali Fuat', 'Initials': 'AF', 'LastName': 'Atmaca', 'Affiliation': 'Deparment of Urology, Memorial Hospital Ankara, Ankara, Turkey.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Neselioglu', 'Affiliation': 'Department of Biochemistry, School of Medicine, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Ozcan', 'Initials': 'O', 'LastName': 'Erel', 'Affiliation': 'Department of Biochemistry, School of Medicine, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Arslan', 'Initials': 'A', 'LastName': 'Ardicoglu', 'Affiliation': 'Department of Urology, School of Medicine Affiliated with Ministry of Health Ankara City Hospital, Ankara Yildirim Beyazit University, Ankara, Turkey.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.07.011']
1816,32788120,Impact of implementation of an individualised thromboprophylaxis protocol in critically ill ICU patients with COVID-19: A longitudinal controlled before-after study.,"INTRODUCTION
An individualised thromboprophylaxis was implemented in critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia to reduce mortality and improve clinical outcome. The aim of this study was to evaluate the effect of this intervention on clinical outcome.
METHODS
In this mono-centric, controlled, before-after study, all consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included. A thromboprophylaxis protocol, including augmented LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT, was implemented on March 31th 2020. Primary endpoint is one-month mortality. Secondary outcomes include two-week and three-week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT). Multiple regression modelling was used to correct for differences between the two groups.
RESULTS
46 patients were included in the before group, 26 patients in the after group. One month mortality decreased from 39.13% to 3.85% (p < 0.001). After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)). The cumulative incidence of VTE and CRRT was respectively 41% and 30.4% in the before group and dropped to 15% (p = 0.03) and 3.8% (p = 0.01), respectively. After correction for confounding variables, risk of VTE (p = 0.03, 6.01 (1.13, 32.12)) and CRRT (p = 0.02, OR 19.21 (1.44, 255.86)) remained significantly higher in the before group.
CONCLUSION
Mortality, cumulative risk of VTE and need for CRRT may be significantly reduced in COVID-19 patients by implementation of a more aggressive thromboprophylaxis protocol. Future research should focus on confirmation of these results in a randomized design and on uncovering the mechanisms underlying these observations.
REGISTRATION NUMBER
NCT04394000.",2020,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","['critically ill ICU patients with COVID-19', 'critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia', '46 patients were included in the before group, 26 patients in the after group', 'consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included']","['LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT', 'individualised thromboprophylaxis protocol']","['week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT', 'mortality', 'month mortality', 'cumulative incidence of VTE and CRRT', 'Mortality, cumulative risk of VTE and need for CRRT', 'CRRT']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",46.0,0.053393,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","[{'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Stessel', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium. Electronic address: bjorn.stessel@jessazh.be.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Vanvuchelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Bruckers', 'Affiliation': 'I-BioStat, Data Science Institute, Hasselt University, Martelarenlaan 42, 3500 Hasselt, Belgium.'}, {'ForeName': 'Laurien', 'Initials': 'L', 'LastName': 'Geebelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Callebaut', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Vandenbrande', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Pellens', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Van Tornout', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Ory', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Karlijn', 'Initials': 'K', 'LastName': 'van Halem', 'Affiliation': 'Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Messiaen', 'Affiliation': 'UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium; Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Herbots', 'Affiliation': 'Department of Cardiology and Coronary Care Unit, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ramaekers', 'Affiliation': 'Chief Medical Officer, Jessa Hospital, Hasselt, Belgium; Leuven Institute for Healthcare Policy (LIHP), University of Leuven, Belgium.'}, {'ForeName': 'Jasperina', 'Initials': 'J', 'LastName': 'Dubois', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.038']
1817,32783799,Baseline Characteristics of Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial.,"Recurrent enteric infections and micronutrient deficiencies, including deficiencies in the tryptophan-kynurenine-niacin pathway, have been associated with environmental enteric dysfunction, potentially contributing to poor child growth and development. We are conducting a randomized, placebo-controlled, 2 × 2 factorial interventional trial in a rural population in Haydom, Tanzania, to determine the effect of 1) antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer, on attained length at 18 months. Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020. Here, we describe the baseline characteristics of the study cohort, risk factors for low enrollment weight, and neonatal adverse events (AEs). Risk factors for a low enrollment weight included being a firstborn child (-0.54 difference in weight-for-age z -score [WAZ] versus other children, 95% CI: -0.71, -0.37), lower socioeconomic status (-0.28, 95% CI: -0.43, -0.12 difference in WAZ), and birth during the preharvest season (November to March) (-0.22, 95% CI: -0.33, -0.11 difference in WAZ). The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively). The study cohort represents a high-risk population for whom interventions to improve child growth and development are urgently needed. Further analyses are needed to understand the persistent impacts of seasonal malnutrition and the interactions between seasonality, socioeconomic status, and the study interventions.",2020,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[""Mother/infant dyads were enrolled within 14 days of the infant's birth from September 2017 to September 2018, with the follow-up to be completed in February 2020"", 'rural population in Haydom, Tanzania', 'Study Participants in the Early Life Interventions for Childhood Growth and Development in Tanzania (ELICIT) Trial']","['antimicrobials (azithromycin and nitazoxanide) and/or 2) nicotinamide, a niacin vitamer', 'placebo']","['lower socioeconomic status', 'respiratory tract infections and neonatal sepsis']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0456103', 'cui_str': 'Sepsis of the newborn'}]",,0.15935,"The most common neonatal serious AEs were respiratory tract infections and neonatal sepsis (2.2 and 1.4 events per 100 child-months, respectively).","[{'ForeName': 'Tarina C', 'Initials': 'TC', 'LastName': 'Parpia', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Elwood', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Scharf', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Joann M', 'Initials': 'JM', 'LastName': 'McDermid', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Anne W', 'Initials': 'AW', 'LastName': 'Wanjuhi', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gratz', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Erling', 'Initials': 'E', 'LastName': 'Svensen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Swann', 'Affiliation': 'School of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, United Kingdom.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Donowitz', 'Affiliation': ""Division of Infectious Disease, Children's Hospital of Richmond at Virginia Commonwealth University, Richmond, Virginia.""}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Jatosh', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Siphael', 'Initials': 'S', 'LastName': 'Katengu', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Paschal', 'Initials': 'P', 'LastName': 'Mdoe', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'Sokoine', 'Initials': 'S', 'LastName': 'Kivuyo', 'Affiliation': 'National Institute for Medical Research, Muhimbili Medical Research Centre, Dar es Salaam, Tanzania.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Houpt', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Estomih', 'Initials': 'E', 'LastName': 'Mduma', 'Affiliation': 'Haydom Global Health Research Centre, Haydom Lutheran Hospital, Haydom, Tanzania.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Platts-Mills', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0918']
1818,32785666,Venetoclax-rituximab with or without bendamustine vs bendamustine-rituximab in relapsed/refractory follicular lymphoma.,"This open-label phase 2 study (CONTRALTO) assessed the safety and efficacy of BCL-2 inhibitor venetoclax (VEN) plus rituximab (R), and VEN plus bendamustine (B) and R, vs B + R (BR) alone in relapsed/refractory (R/R) follicular lymphoma. Patients in the chemotherapy-free arm (arm A: VEN + R) received VEN 800 mg/d plus R 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 4, 6, 8, 10, and 12. After a safety run-in with VEN 600 mg, patients in the chemotherapy-containing cohort were randomized to either VEN + BR (arm B; VEN 800 mg/d for 1 year + 6 cycles of BR [B 90 mg/m2 on days 1 and 2 and R 375 mg/m2 on day 1]) or 6 cycles of BR (arm C). Overall, 163 patients were analyzed (9 in the safety run-in and 52, 51, and 51 in arms A, B, and C, respectively). Complete metabolic/complete response rates were 17% (arm A), 75% (arm B), and 69% (arm C). Of patients in arm B, only 61% received ≥90% of the planned B dose vs 96% of patients in arm C. More frequent hematologic toxicity resulted in more reduced dosing/treatment discontinuation in arm B vs arm C. Rates of grade 3/4 adverse events were 51.9%, 93.9%, and 60.0% in arms A, B, and C, respectively. VEN + BR led to increased toxicity and lower dose intensity of BR than in arm C, but efficacy was similar. Optimizing dose and schedule to maintain BR dose intensity may improve efficacy and tolerability of VEN + BR, while VEN + R data warrant further study. This study was registered at www.clinicaltrials.gov as #NCT02187861.",2020,"More frequent hematologic toxicity resulted in more reduced dosing/treatment discontinuation in Arm B versus C. Rates of grade 3/4 adverse events were 51.9%, 93.9% and 60.0% in Arms A, B and C, respectively.","['163 patients were analyzed: 9 in safety run-in; 52, 51, and 51 in Arms A, B, and C, respectively', 'relapsed/refractory follicular lymphoma']","['planned bendamustine', 'BCL-2 inhibitor venetoclax (VEN) plus rituximab (R), and VEN plus bendamustine (B) and R, versus BR alone', 'VEN+BR', 'VEN', 'Venetoclax-rituximab ± bendamustine vs bendamustine-rituximab']","['efficacy and tolerability', 'toxicity', 'hematologic toxicity', 'Complete metabolic/complete response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]","[{'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C4319834', 'cui_str': 'B-cell lymphoma 2 inhibitor'}, {'cui': 'C4079830', 'cui_str': 'venetoclax'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",163.0,0.0620375,"More frequent hematologic toxicity resulted in more reduced dosing/treatment discontinuation in Arm B versus C. Rates of grade 3/4 adverse events were 51.9%, 93.9% and 60.0% in Arms A, B and C, respectively.","[{'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Hematology ""L. e A. Seràgnoli,"" University of Bologna, Bologna, Italy.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Sam L S', 'Initials': 'SLS', 'LastName': 'Yuen', 'Affiliation': 'Department of Haematology, Calvary Mater Newcastle, Waratah, NSW, Australia.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Rusconi', 'Affiliation': 'Division of Hematology, Niguarda Hospital, Milan, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fleury', 'Affiliation': 'Department of Hematology, Maisonneuve-Rosemont Hospital and University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Katell', 'Initials': 'K', 'LastName': 'Le Dû', 'Affiliation': 'Hematology Department, Clinique Victor Hugo, Le Mans, France.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Arthur', 'Affiliation': 'Department of Haematology, Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pro', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Chicago, IL.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gritti', 'Affiliation': 'Hematology and BMT Unit, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Crump', 'Affiliation': 'Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Petrich', 'Affiliation': 'AbbVie, North Chicago, IL.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Samineni', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sinha', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Punnoose', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Szafer-Glusman', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Spielewoy', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland; and.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Mobasher', 'Affiliation': 'Genentech, Inc., South San Francisco, CA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Humphrey', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kornacker', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland; and.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Department of Medicine III, University of Munich, Munich, Germany.'}]",Blood,['10.1182/blood.2020005588']
1819,32840767,Better Treatment Values in Local Application of Tranexamic Acid (TXA) than Intravenous Application with the Same Dose in Total Hip Arthroplasty.,"INTRODUCTION
The aim of our study was to investigate the hemostatic effect of local and intravenously administered tranexamic acid (TXA) at the same dose in total hip arthroplasty.
METHODS
The prospective study included 72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019. The patients enrolled in the study were randomly divided into two groups: the observation group (36 patients were injected with 2.0 g TXA in 10 mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule) and the control group (36 patients were given an intravenous infusion of 2 g TXA in 200 mL 0.9% NaCl 30 min before the operation). In each patient, apparent blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion were compared between the two groups after treatment. Hematocrit (Hct) and hemoglobin (Hb) levels were recorded at postoperative day (POD) 1, 2, 3, 7, and 10. We also recorded the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) before the operation and 12 h postoperative and POD 1, 3, 7, and 10. The incidence of deep venous thrombosis and pulmonary embolism was also taken into account.
RESULTS
In the observation group, apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion were lower compared than the control group (P < 0.001). The levels of Hct and Hb were compared between the two groups at POD 1, 2, 3, 7, and 10, and the observation group reported higher levels of Hct and Hb (P < 0.001). The levels of CRP and IL-6 were compared between the two groups at POD 1, 3, 7, and 10, and the observation group reported lower levels of CRP and IL-6 than the control group (P < 0.001). On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
CONCLUSIONS
Local and intravenous applications of TXA at the same dose are effective approaches in terms of reducing bleeding and inflammatory reaction with a good safety profile; however, the effect of local application had superior therapeutic values.",2020,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
","['72 patients who underwent total hip arthroplasty in our hospital between March 2018 and March 2019', 'Total Hip Arthroplasty', 'total hip arthroplasty']","['intravenous infusion of 2\xa0g TXA', 'TXA in 10\xa0mL 0.9% NaCl using the joint cavity drainage tube after suturing the joint capsule', 'tranexamic acid (TXA', 'Tranexamic Acid (TXA', 'TXA']","['Hematocrit (Hct) and hemoglobin (Hb) levels', 'blood loss, hidden blood loss, average blood transfusion, and the number of cases receiving blood transfusion', 'pulmonary embolism', 'hemostatic effect', 'levels of Hct and Hb', 'incidence of deep venous thrombosis', 'apparent blood loss, hidden blood loss, average blood transfusion volume, and the number of patients receiving blood transfusion', 'incidence of deep venous thrombosis and pulmonary embolism', 'levels of CRP and IL-6', 'levels of C-reactive protein (CRP) and interleukin-6 (IL-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0502723', 'cui_str': 'Structure of joint cavity'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0206207', 'cui_str': 'Structure of articular capsule'}]","[{'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",72.0,0.0284129,"On POD 7, there was no pulmonary embolism in both groups, and no significant difference was observed in the incidence of deep venous thrombosis between the two groups (P > 0.05).
","[{'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Desi', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wen', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Department of Orthopaedics, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. panjiang@ccmu.edu.cn.'}]",Advances in therapy,['10.1007/s12325-020-01454-3']
1820,31820334,Effect of Smartphone-Based Telemonitored Exercise Rehabilitation among Patients with Coronary Heart Disease.,"The aim of this study was to investigate the effects of telemonitored exercise rehabilitation on patients with coronary heart disease (CHD) in China. Ninety-six patients with stable CHD were included and analyzed (48 in telemonitored group and 48 in control group). All patients received routine follow-up, and patients in telemonitored group participated in smartphone-based telemonitored cardiac rehabilitation. Patients' demographic information, medical history, diagnosis and treatment of CHD, and laboratory results were collected. The difference of cardiopulmonary exercise testing (CPET), blood test, and echocardiographic parameters; exercise habits; control rate of blood lipid and blood glucose; and incidence of adverse events between the two groups during 6 months of follow-up was analyzed. After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group. Telemonitored exercise rehabilitation is an effective rehabilitation mode for CHD patients in China.",2020,"After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group.","['CHD patients in China', 'patients with coronary heart disease (CHD) in China', 'Ninety-six patients with stable CHD', 'Patients with Coronary Heart Disease']","['Smartphone-Based Telemonitored Exercise Rehabilitation', 'smartphone-based telemonitored cardiac rehabilitation', 'Telemonitored exercise rehabilitation', 'telemonitored exercise rehabilitation']","['cardiopulmonary exercise testing (CPET), blood test, and echocardiographic parameters; exercise habits; control rate of blood lipid and blood glucose; and incidence of adverse events', 'VO 2peak , exercise compliance']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",96.0,0.0186907,"After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group.","[{'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, 100191, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China. beate_vv@bjmu.edu.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}]",Journal of cardiovascular translational research,['10.1007/s12265-019-09938-6']
1821,32795835,Is there a role for insulin-like growth factor inhibition in the treatment of COVID-19-related adult respiratory distress syndrome?,"Adult respiratory distress syndrome (ARDS) is the leading cause of death associated with SARS-CoV-2 infection and COVID-19. IGF-1 has been implicated in ARDS, yet its role in relation to COVID-19-related lung injury has not been investigated. We hypothesize that blockage of the IGF-1 receptor (IGF-1R) mitigates lung injury and decreases the risk of death in patients COVID-19-related ARDS. Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens. Rising levels of IGF-1 in bronchioalveolar fluid (BAL) and increased IGF-1 mRNA expression in lung tissues (but declining serum IGF-1 levels) have been found in late stage ARDS compared with early lung injury. Blockage of IGF-1R decreases lung tissue damage and increases survival in bleomycin-induced as well as H1N1 influenza-related lung injury in animal models. Teprotumumab is a monoclonal antibody directed against the IGF-1R that was FDA-approved in 2020 for the treatment of Graves' orbitopathy. In order to determine if teprotumumab may reduce lung injury and death related to ARDS in the setting of COVID-19, preliminary clinical data is needed. IGF-1 levels in serum and BAL fluid must be measured in patients with COVID-19-related ARDS. Histopathology from lung samples from patients with COVID-19-related ARDS must be examined for increased expression of the IGF-1R. Once these are ascertained, and if the data support IGF-1 involvement, a randomized, placebo-controlled phase 2A trial of teprotumumab therapy in the setting of COVID-19-related ARDS and non-COVID-19-related ARDS designed to generate initial data on short-term efficacy, safety, dosing and administration should be performed.",2020,Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens.,"['COVID-19-related adult respiratory distress syndrome', 'Patients with fibroproliferative ARDS', 'Adult respiratory distress syndrome (ARDS', 'patients with COVID-19-related ARDS']","['placebo', 'IGF-1']","['IGF-1 levels', 'IGF-1 and IGF-1R staining', 'risk of death', 'expression of the IGF-1R']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0140080', 'cui_str': 'Insulin-Like-Growth Factor I Receptor'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.132459,Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens.,"[{'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Winn', 'Affiliation': 'Department of Ophthalmology, University of California San Francisco, San Francisco, CA, United States; Ophthalmology Section, Surgical Service, San Francisco Veterans Affairs Medical Center, San Francisco, CA, United States. Electronic address: bryan.winn@ucsf.edu.'}]",Medical hypotheses,['10.1016/j.mehy.2020.110167']
1822,32795903,Ventilatory support during whole-body row training improves oxygen uptake efficiency in patients with high-level spinal cord injury: A pilot study.,"High-level spinal cord injury (SCI) is characterized by profound respiratory compromise. One consequence is a limitation of whole-body exercise-based rehabilitation, reducing its cardioprotective effect. We investigated the use of ventilatory support during training on cardiorespiratory response to exercise. Nine subjects with high-level SCI (T3-C4) were included in this double-blind sham-controlled study. All had training adaptations plateauing for more than 6 months before enrolling in the study. After performing baseline assessment, participants were randomly assigned to continue training with non-invasive ventilation (NIV: n = 6: IPAP = 20 ± 2, EPAP: 3 cmH 2 O) or sham (n = 3: IPAP = 5, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests. We compared the oxygen uptake efficiency slope (OUES, the rate of increases in VO 2 in relation to increasing VE) before and after training. Training with NIV increased OUES both compared to baseline (4.1 ± 1.1 vs. 3.4 ± 1.0, i.e. +20 ± 12%, p < 0.05) and Sham (p = 0.01), representing an increase in ability to uptake oxygen for a given ventilation. This result was sustained without NIV during the test, suggesting improved cardiopulmonary reserve. Best responders were the youngest whose characteristics were very similar to sham participants. In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham). Our results are very suggestive of a positive effect of ventilatory support during whole-body exercise in high-level SCI. Training adaptations found are of great importance since this sub-population of patients have the greatest need for exercise-based cardio-protection.",2020,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","['Nine subjects with high-level SCI (T3-C4', 'patients with high-level spinal cord injury']","['continue training with non-invasive ventilation (NIV: n\xa0=\xa06: IPAP\xa0=\xa020\xa0±\xa02, EPAP: 3 cmH 2 O) or sham (n\xa0=\xa03: IPAP\xa0=\xa05, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests', 'Ventilatory support during whole-body row training']","['oxygen uptake efficiency', 'weekly rowing distance', 'ability to uptake oxygen', 'oxygen uptake efficiency slope (OUES']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",9.0,0.0857854,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, 75013, Paris, France. Electronic address: isabelle.vivodtzev@sorbonne.universite.fr.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Napolitano', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106104']
1823,32800493,Impact of Granulocyte Colony-Stimulating Factor (G-CSF) and Epoetin (EPO) on Hematologic Toxicities and Quality of Life in Patients During Adjuvant Chemotherapy in Early Breast Cancer: Results From the Multi-Center Randomized ADEBAR Trial.,"BACKGROUND
Hematologic toxicities are one of the greatest challenges in adjuvant chemotherapy for breast cancer. This analysis of the ADEBAR trial aims to evaluate application and effect of granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO) on hematologic parameters and fatigue in patients with breast cancer during chemotherapy.
PATIENTS AND METHODS
In the ADEBAR trial, 1493 patients with node-positive primary breast cancer were randomized to either 6 × 5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or 4 × epirubicin and cyclophosphamide followed by 4 × docetaxel (EC-DOC). Co-medication with G-CSF or EPO was applied to treat chemotherapy-induced leukopenia or anemia. Fatigue was assessed at baseline and after one-half of the chemotherapy.
RESULTS
In total, 899 patients could be included in the analysis. There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively. Hemoglobin levels (B = -0.41; P < .001) were affected by treatment regimen. Fatigue during chemotherapy was mostly affected by the level of fatigue before the start of chemotherapy (B = 0.41; P < .001). Patients with G-CSF application in the preceding cycle showed an increased fatigue score (B = 5.43; P = .02).
CONCLUSION
We showed that fatigue during adjuvant chemotherapy was mostly affected by the level of fatigue present before the start of chemotherapy. This result suggests that the level of fatigue before the start of treatment should be included as an important factor when deciding on type and toxicity of chemotherapy in early breast cancer.",2020,"There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively.","['Early Breast Cancer', 'breast cancer', '1493 patients with node-positive primary breast cancer', 'Patients', '899 patients could be included in the analysis', 'patients with breast cancer during chemotherapy']","['epirubicin and cyclophosphamide', 'Adjuvant Chemotherapy', 'granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO', 'Granulocyte Colony-Stimulating Factor (G-CSF) and Epoetin (EPO', '5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or', 'Co-medication with G-CSF or EPO']","['Hemoglobin levels', 'leukopenia or anemia', 'Hematologic Toxicities and Quality of Life', 'fatigue score', 'leucocyte or hemoglobin levels and application of G-CSF and EPO', 'Fatigue', 'hematologic parameters and fatigue']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",1493.0,0.0476588,"There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively.","[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany. Electronic address: inga.bekes@uniklinik-ulm.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eichler', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Singer', 'Affiliation': 'Insitute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Centre Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas W P', 'Initials': 'TWP', 'LastName': 'Friedl', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Cancer Center, Department of Obstetrics and Gynecology, University of Munich, Munich, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Forstbauer', 'Affiliation': 'Hemato-Oncological Practice Dres Forstbauer and Ziske, Troisdorf, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dannecker', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Kiechle', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Krisztian', 'Initials': 'K', 'LastName': 'Lato', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Visnja', 'Initials': 'V', 'LastName': 'Fink', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.03.008']
1824,32800494,Phase 1 Dose-Escalation Study of Triweekly Nab-Paclitaxel Combined With S-1 for HER2-Negative Metastatic Breast Cancer.,"PURPOSE
To evaluate the efficacy, toxicity, maximum tolerated dose, and recommended dose of triweekly nab-paclitaxel (nab-PTX) and S-1 combination chemotherapy for patients with metastatic breast cancer.
PATIENTS AND METHODS
This phase 1 study was conducted with a standard 3 + 3 dose escalation design. Every 3 weeks, the patients received nab-PTX at 180-260 mg/m 2 on day 1 and S-1 at 65-80 mg/m 2 daily on days 1 to 14.
RESULTS
Ten HER2-negative metastatic breast cancer patients were enrolled; their median number of prior chemotherapy regimens was 3. Dose-limiting toxicity was observed in the first patient assigned to level 4; grade 4 febrile neutropenia and grade 3 neurotoxicity such as needing a wheelchair occurred. Therefore, an additional patient was not assigned to level 4. The maximum tolerated dose was considered level 4 (260 mg/m 2 nab-PTX with 80 mg/m 2 S-1). The recommended dose determined was level 3 (220 mg/m 2 nab-PTX with 80 mg/m 2 S-1). The response rate was 60.0%. The disease control rate was 70.0%.
CONCLUSION
This combination chemotherapy therapy was feasible and safe for patients with HER2-negative metastatic breast cancer.",2020,Dose-limiting toxicity was observed in the first patient assigned to level 4; grade 4 febrile neutropenia and grade 3 neurotoxicity such as needing a wheelchair occurred.,"['patients with metastatic breast cancer', 'patients with HER2-negative metastatic breast cancer', 'Ten HER2-negative metastatic breast cancer patients', 'HER2-Negative Metastatic Breast Cancer']","['triweekly nab-paclitaxel (nab-PTX) and S-1 combination chemotherapy', 'chemotherapy therapy', 'Triweekly Nab-Paclitaxel Combined With S-1', 'nab-PTX']","['disease control rate', 'Dose-limiting toxicity', 'response rate', 'efficacy, toxicity, maximum tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0378932,Dose-limiting toxicity was observed in the first patient assigned to level 4; grade 4 febrile neutropenia and grade 3 neurotoxicity such as needing a wheelchair occurred.,"[{'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Toba', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan. Electronic address: ht1109@tokushima-u.ac.jp.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Aoyama', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Surgery, Takamatsu Municipal Hospital, Busshozan-cho, Takamatsu, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takechi', 'Affiliation': 'Department of Surgery, Shikoku Central Hospital of the Mutual Aid Association of Public School Teachers, Kawanoe-cho, Shikokuchuo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tangoku', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.07.012']
1825,31813763,A pharmacist-led medicines review intervention in community-dwelling Māori older adults- a feasibility study protocol.,"BACKGROUND
Pharmacists have a role to play in supporting the optimal use of medicines to ensure older adults receive therapeutic benefit whilst minimising medicines-related harm. In Aotearoa New Zealand (NZ), Māori (Indigenous people of NZ) experience inequities in the determinants of health, including access to medicines, resulting in increased morbidity, earlier onset of chronic conditions and reduced life expectancy. This study aims to test the feasibility of a pharmacist-led medicines review intervention in community-dwelling Māori older adults.
METHOD
This is a non-randomised, non-controlled feasibility study undertaken within a kaupapa Māori methodological framework which supports the right of Māori to be included throughout the research process and seeks to potentiate transformational, positive change for Māori. The research pharmacist will recruit 30 participants (Māori; 55 years or older; community-dwelling). Participants will undergo a medicines education session with the pharmacist (medicines reconciliation, medicines information, well-being goal setting), with the option to proceed to a medicines optimisation session that includes the participant, pharmacist and primary prescriber (review of potentially inappropriate prescribing (PIP); medicines management plan development). Primary outcomes: participant and prescriber acceptability of intervention. Secondary outcomes include baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen.
ETHICS AND DISSEMINATION
Ethical approval was granted by the Northern B Health and Disability Committee (9/NTB/106). Study results will be disseminated to various stakeholders including Māori communities, health practitioners and providers, and researchers through meetings and conference presentations, lay summaries and peer-reviewed journals. This study is an example of health service design, delivery and evaluation, informed by Indigenous knowledge and methodology, developed explicitly to address inequities in health outcomes for, and with, Māori and will inform the decision to proceed to a randomised controlled trial to test the effect of this intervention.
TRIAL REGISTRATION NUMBER
ACTRN12619001070123.",2020,"Secondary outcomes include baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen.
","['30 participants (Māori; 55 years or older; community-dwelling', 'community-dwelling Māori older adults']","['pharmacist-led medicines review intervention', 'medicines optimisation session that includes the participant, pharmacist and primary prescriber (review of potentially inappropriate prescribing (PIP); medicines management plan development']","['baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen', 'prescriber acceptability of intervention']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3839881', 'cui_str': 'Change made'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0784306,"Secondary outcomes include baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hikaka', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand; Waitematā District Health Board, Auckland, New Zealand. Electronic address: j.hikaka@auckland.ac.nz.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': ""School of Pharmacy, Queen's University, Belfast, UK.""}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Te Kupenga Hauora Māori, University of Auckland, New Zealand.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Connolly', 'Affiliation': 'Waitematā District Health Board, Auckland, New Zealand; Freemasons Department of Geriatric Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Martini', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.12.004']
1826,32809136,Conservative oxygen therapy for mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy.,"PURPOSE
Liberal use of oxygen may contribute to secondary brain injury in patients with hypoxic-ischaemic encephalopathy (HIE). However, there are limited data on the effect of different oxygen regimens on survival and neurological disability in HIE patients.
METHODS
We undertook a post-hoc analysis of the 166 patients with suspected HIE enrolled in a trial comparing conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary endpoint for the current analysis was death or unfavourable neurological outcome at day 180. Key secondary outcomes were day 180 mortality, and cause-specific mortality.
RESULTS
Patients with HIE allocated to conservative oxygen spent less time in the ICU with an SpO 2 ≥ 97% (26 h [interquartile range (IQR) 13-45 vs. 35 h [IQR 19-70], absolute difference, 9 h; 95% CI - 21.4 to 3.4). A total of 43 of 78 patients (55.1%) assigned to conservative oxygen and 49 of 72 patients (68.1%) assigned to usual oxygen died or had an unfavourable neurological outcome at day 180; odds ratio 0.58; 95% CI 0.3-1.12; P = 0.1 adjusted odds ratio 0.54; 95% CI 0.23-1.26; P = 0.15. A total of 37 of 86 patients (43%) assigned to conservative oxygen and 46 of 78 (59%) assigned to usual oxygen had died by day 180; odds ratio 0.53; 95% CI 0.28-0.98; P = 0.04; adjusted odds ratio 0.56; 95% CI 0.25-1.23; P = 0.15. Cause-specific mortality was similar by treatment group.
CONCLUSIONS
Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180. The potential for important benefit or harm from conservative oxygen therapy in HIE patients is not excluded by these data.",2020,"CONCLUSIONS
Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","['mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy', '1000 mechanically ventilated ICU patients', '166 patients with suspected HIE enrolled in a trial comparing', 'Patients with HIE', 'HIE patients', 'patients with hypoxic-ischaemic encephalopathy (HIE']","['conservative oxygen therapy with usual oxygen therapy', 'Conservative oxygen therapy']","['day 180 mortality, and cause-specific mortality', 'survival and neurological disability', 'death or unfavourable neurological outcomes', 'Cause-specific mortality', 'death or unfavourable neurological outcome']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1000.0,0.358589,"CONCLUSIONS
Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Division of Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06196-y']
1827,32810739,"The mitochondria-targeted antioxidant MitoQ, attenuates exercise-induced mitochondrial DNA damage.","High-intensity exercise damages mitochondrial DNA (mtDNA) in skeletal muscle. Whether MitoQ - a redox active mitochondrial targeted quinone - can reduce exercise-induced mtDNA damage is unknown. In a double-blind, randomized, placebo-controlled design, twenty-four healthy male participants consisting of two groups (placebo; n = 12, MitoQ; n = 12) performed an exercise trial of 4 x 4-min bouts at 90-95% of heart rate max. Participants completed an acute (20 mg MitoQ or placebo 1-h pre-exercise) and chronic (21 days of supplementation) phase. Blood and skeletal muscle were sampled immediately pre- and post-exercise and analysed for nuclear and mtDNA damage, lipid hydroperoxides, lipid soluble antioxidants, and the ascorbyl free radical. Exercise significantly increased nuclear and mtDNA damage across lymphocytes and muscle (P < 0.05), which was accompanied with changes in lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P < 0.05). Acute MitoQ treatment failed to impact any biomarker likely due to insufficient initial bioavailability. However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05). Our work is the first to show a protective effect of chronic MitoQ supplementation on the mitochondrial and nuclear genomes in lymphocytes and human muscle tissue following exercise, which is important for genome stability.",2020,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","['twenty-four healthy male participants consisting of two groups (placebo; n\xa0=\xa012, MitoQ; n\xa0=\xa012']","['High-intensity exercise damages mitochondrial DNA (mtDNA', 'MitoQ or placebo', 'placebo']","['Blood and skeletal muscle', 'lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P', 'nuclear and mtDNA damage across lymphocytes and muscle (P', 'mtDNA damage in lymphocytes and muscle tissue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",24.0,0.192572,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'Ciara M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': 'Ulster University, Nursing and Health Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Cobley', 'Affiliation': 'Free Radical Research Group, University of the Highlands and Islands, Centre for Health Sciences, Inverness, IV2 3JH, UK.'}, {'ForeName': 'Gareth W', 'Initials': 'GW', 'LastName': 'Davison', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK. Electronic address: gw.davison@ulster.ac.uk.'}]",Redox biology,['10.1016/j.redox.2020.101673']
1828,32811637,Treating cannabis use disorder: Exploring a treatment as needed model with 34-month follow-up.,"Research has demonstrated that motivational enhancement (MET) and cognitive behavioral therapy (CBT) are some of the most effective interventions for adults with cannabis use disorder (CUD). As few as two sessions of combined MET and CBT has produced abstinence and reductions in cannabis use greater than delayed treatment controls. Despite their efficacy, outcomes in previous studies yielded abstinence rates from cannabis in the range of 20-30% at follow-ups of 6 to 12 months, and CUD remained a chronic condition for many. Additional models of providing treatment ""as needed"" (PRN), rather than as a single fixed-dose, are necessary to meet the different needs of adults with CUD and reengage those who do not respond to treatment initially or who relapse later. In the current study, 87 adults who met DSM-IV criteria for cannabis dependence were randomly assigned to receive either a fixed-dose of nine sessions of MET/CBT or to a PRN condition that provided a smaller initial dose of treatment, but allowed repeated access to treatment for 28 months. Cannabis use and associated problems were assessed every six months throughout a 34-month period. More than one-third of participants in the PRN condition accessed additional treatment episodes, but the total number of treatment sessions that participants utilized was comparable across conditions. Both treatments yielded significant reductions in cannabis use and associated problems at each follow-up. Contrary to hypotheses, the PRN condition did not yield better outcomes at the longer-term follow-ups. The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes. Future studies should test active approaches to reengaging participants with treatment when initial outcomes are less than optimal.",2020,"The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes.","['87 adults who met DSM-IV criteria for cannabis dependence', 'adults with CUD and reengage those who do not respond to treatment initially or who relapse later', 'adults with cannabis use disorder (CUD', 'Treating cannabis use disorder']","['CBT', 'cognitive behavioral therapy (CBT']","['rates of abstinence', 'abstinence rates', 'cannabis use and associated problems', 'total number of treatment sessions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",87.0,0.061929,"The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes.","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Stephens', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: stephens@vt.edu.'}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: robrina.walker@utsouthwestern.edu.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'DeMarce', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: jdemarce@vt.edu.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Lozano', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: brian.lozano@va.gov.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Rowland', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: jared.rowland@va.gov.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, 909 NE 43rd St. Suite 304, Seattle, WA 98105, United States of America. Electronic address: ddwalker@u.washington.edu.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Roffman', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, 909 NE 43rd St. Suite 304, Seattle, WA 98105, United States of America. Electronic address: roffman@uw.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108088']
1829,32819740,The Impact of a 20-Minute Animal-Assisted Activity Session on the Physiological and Emotional States in Patients With Fibromyalgia.,"OBJECTIVE
To study the direct physiological and emotional impact of an animal-assisted activity (AAA) session (a form of complementary and integrative medicine) in patients with fibromyalgia (FM).
PATIENTS AND METHODS
The study population consisted of 221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018. This was a randomized controlled trial. Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only). To gain a better understanding of the direct physiological and emotional effects of AAA in patients with FM, we used multiple noninvasive physiologic-emotional biomarkers, including salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters, in addition to standardized pain and mood-based questionnaires.
RESULTS
Results show a decrease in heart rate, an increase in heart rate variability, an increase in well-being survey scores, an increase in salivary oxytocin, and subsequent tympanic membrane temperature changes, suggesting that participants in the treatment group were in a more positive emotional-physiologic state as a result of the AAA session compared with the control group.
CONCLUSION
Our results suggest that a 20-minute therapy dog visit in an outpatient setting can significantly and positively impact the physical and mental health of patients with FM.",2020,Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only).,"[""221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018"", 'patients with fibromyalgia (FM', 'Patients With Fibromyalgia', 'patients with FM']","['certified therapy dog and handler) or the control group (a\xa020-minute session with a handler only', '20-Minute Animal-Assisted Activity Session', 'animal-assisted activity (AAA) session (a form of complementary and integrative medicine']","['heart rate', 'salivary oxytocin, and subsequent tympanic membrane temperature changes', 'well-being survey scores', 'positive emotional-physiologic state', 'heart rate variability', 'salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",221.0,0.0903234,Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only).,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Ragen T S', 'Initials': 'RTS', 'LastName': 'McGowan', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Smidt', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Turpin', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Langenfeld-McCoy', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Bauer', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Arya B', 'Initials': 'AB', 'LastName': 'Mohabbat', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN. Electronic address: mohabbat.arya@mayo.edu.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.04.037']
1830,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
1831,33234112,Feasibility and safety of exercise training and nutritional support prior to haematopoietic stem cell transplantation in patients with haematologic malignancies.,"BACKGROUND
Prehabilitation with regular exercise and nutritional care for patients undergoing surgeries for malignant disease was recently introduced to increase physiologic reserve prior to the procedure, accelerate recovery and improve outcomes. This study aimed to investigate the feasibility and safety of combined exercise training and nutritional support in patients with haematologic malignancies prior to haematopoietic stem cell transplantation (HSCT).
METHODS
In this single-arm pilot study, 34 HSCT candidates were enrolled at least two weeks before admission for the procedure. Patients performed aerobic exercises at least 4 days per week for 20-30 min and strength exercises 3 days per week for 10-20 min. They received daily supplements of whey protein (0.3-0.4 g/kg body weight) and oral nutritional supplements if needed. The primary endpoints were feasibility (acceptability > 75%, attrition < 20%, adherence > 66%) and safety. The secondary endpoints were fat-free mass (FFM), muscle strength, physical performance and health-related quality of life (HRQoL) at HSCT.
RESULTS
The rate of acceptability, attrition and adherence to aerobic exercise, strength exercise and protein supplement consumption was 82.4, 17.8, 71, 78 and 80%, respectively. No severe adverse events were reported. Twenty-eight patients participated in the study for a median of 6.0 weeks (range, 2-14). They performed aerobic exercises 4.5 days per week for 132 min per week and strength exercises 3.0 times per week. Patients consumed 20.7 g of extra protein daily. At the end of the programme, we recorded increases of 1.1 kg in FFM (p = 0.011), 50 m in walking distance in the 6-min walking test (6MWT) (p < 0.001), 3.3 repetitions in the 30-s chair-stand test (30sCST) score (p < 0.001) and 2.6 kg in handgrip strength (p = 0.006). The EORTC QLQ-C30 scores improved by 8.6 (p < 0.006) for global health status, 8.3 (p = 0.009) for emotional functioning, and 12.1 (p = 0.014) for social functioning. There was less fatigue, nausea and insomnia (p < 0.05).
CONCLUSIONS
Our study shows that a multimodal intervention programme with partially supervised exercise training combined with nutritional support prior to HSCT is feasible and safe. Patients showed improvements in FFM, physical performance and HRQoL. Additional research is needed to assess the possible positive effects of such interventions.",2020,"The EORTC QLQ-C30 scores improved by 8.6 (p < 0.006) for global health status, 8.3 (p = 0.009) for emotional functioning, and 12.1 (p = 0.014) for social functioning.","['34 HSCT candidates were enrolled at least two weeks before admission for the procedure', 'patients undergoing surgeries for malignant disease', 'patients with haematologic malignancies prior to haematopoietic stem cell transplantation (HSCT', 'patients with haematologic malignancies', 'Twenty-eight patients participated in the study for a median of 6.0\u2009weeks (range, 2-14']","['exercise training and nutritional support prior to haematopoietic stem cell transplantation', 'aerobic exercises', 'regular exercise and nutritional care', 'combined exercise training and nutritional support']","['rate of acceptability, attrition and adherence to aerobic exercise, strength exercise and protein supplement consumption', '30-s chair-stand test (30sCST) score', 'fat-free mass (FFM), muscle strength, physical performance and health-related quality of life (HRQoL) at HSCT', 'severe adverse events', 'feasibility (acceptability >\u200975%, attrition <\u200920%, adherence >\u200966%) and safety', 'emotional functioning', 'feasibility and safety', '6-min walking test (6MWT', 'handgrip strength', 'fatigue, nausea and insomnia', 'EORTC QLQ-C30 scores', 'FFM, physical performance']","[{'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}]",28.0,0.0603808,"The EORTC QLQ-C30 scores improved by 8.6 (p < 0.006) for global health status, 8.3 (p = 0.009) for emotional functioning, and 12.1 (p = 0.014) for social functioning.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rupnik', 'Affiliation': 'Department of Hematology, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia. erik.rupnik@kclj.si.'}, {'ForeName': 'Matevz', 'Initials': 'M', 'LastName': 'Skerget', 'Affiliation': 'Department of Hematology, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Matjaz', 'Initials': 'M', 'LastName': 'Sever', 'Affiliation': 'Department of Hematology, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Irena Preloznik', 'Initials': 'IP', 'LastName': 'Zupan', 'Affiliation': 'Department of Hematology, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Ogrinec', 'Affiliation': 'Institute for Medical Rehabilitation, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ursic', 'Affiliation': 'Institute for Medical Rehabilitation, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Natasa', 'Initials': 'N', 'LastName': 'Kos', 'Affiliation': 'Institute for Medical Rehabilitation, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cernelc', 'Affiliation': 'Department of Hematology, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Samo', 'Initials': 'S', 'LastName': 'Zver', 'Affiliation': 'Department of Hematology, University Medical Centre Ljubljana, Zaloska cesta 7, 1000, Ljubljana, Slovenia.'}]",BMC cancer,['10.1186/s12885-020-07637-z']
1832,32827835,Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants.,"AIM
The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.
METHODS
This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.
RESULTS
Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.
CONCLUSIONS
Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.
TRIAL REGISTRATION
Clinicaltrials. gov: NCT00378560 and NCT00411749.",2020,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"['female Japanese 4vHPV clinical trial participants', 'Japanese female clinical trial participants', 'Japanese young women aged 18-26 years (N\u202f=\u202f1021; NCT00378560) and girls aged 9-17 years (N\u202f=\u202f107; NCT00411749']","['vaccination with quadrivalent human papillomavirus vaccine', 'injection-site reactions', '4vHPV vaccine', 'quadrivalent human papillomavirus (4vHPV) vaccine', 'placebo']","['severe injection-site AEs', 'erythema, pain, pruritus, and swelling ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.597729,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: shinya.murata@merck.com.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Shirakawa', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: masayoshi.shirakawa@merck.com.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshie.sugawara@merck.com.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Shuto', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: michiko.shutou@merck.com.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sawata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: miyuki.sawata@merck.com.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshiyuki.tanaka@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100205']
1833,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND
Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS
A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS
The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS
The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
1834,33234777,Supraglottic jet oxygenation and ventilation reduces desaturation during bronchoscopy under moderate to deep sedation with propofol and remifentanil: A randomised controlled clinical trial.,"BACKGROUND
Hypoxaemia is frequently seen during flexible bronchoscopies that are done with a nasal approach under the traditional sedation with propofol. This study investigated the potential benefits of supraglottic jet oxygenation and ventilation (SJOV) using the Wei nasal jet tube (WNJ) in reducing hypoxaemia in patients undergoing bronchoscopy under moderate to deep intravenous sedation using a propofol, lidocaine and remifentanil cocktail.
OBJECTIVES
Our primary objective was to evaluate the efficacy and complications of SJOV via the WNJ during flexible bronchoscopy under moderate to heavy sedation with propofol and remifentanil.
DESIGN
A randomised controlled clinical trial.
SETTING
The 180th Hospital of People's Liberation Army, Quanzhou, China, from 1 June to 1 November 2019.
PATIENTS
A total of 280 patients aged ≥18 years with American Society of Anesthesiologists' physical status 1 to 3 undergoing flexible bronchoscopy were studied.
INTERVENTIONS
Patients were assigned randomly into one of two groups, a nasal cannula oxygenation (NCO) group (n = 140) using a nasal cannula to deliver oxygen (4 l min) or the SJOV group (n = 140) using a WNJ connected to a manual jet ventilator to provide SJOV at a driving pressure of 103 kPa, respiratory rate 20 min, FIO2 1.0 and inspiratory:expiratory (I:E) ratio 1:2.
MAIN OUTCOME MEASURES
The primary outcome was an incidence of desaturation (defined as SpO2 < 90%) during the procedure. Other adverse events related to the sedation or SJOV were also recorded.
RESULTS
Compared with the NCO group, the incidence of desaturation in the SJOV group was lower (NCO 37.0% vs. SJOV 13.1%) (P < 0.001). Patients in the SJOV group had a higher incidence of a dry mouth at 1 min (13.1% vs. 1.5%, P < 0.001) than at 30 min (1.5% vs. 0%, P = 0.159) or at 24 h (0% vs. 0%). There was no significant difference between the groups in respect of sore throat, subcutaneous emphysema or nasal bleeding.
CONCLUSIONS
SJOV via a WNJ during flexible bronchoscopy under moderate to deep sedation with propofol and remifentanil significantly reduces the incidence of desaturation when compared with regular oxygen supplementation via a nasal cannula. Patients in the SJOV group had an increased incidence of transient dry mouth.
TRIAL REGISTRATION
Registered at www.chictr.org.cn (ChiCTR1900023514).",2020,"There was no significant difference between the groups in respect of sore throat, subcutaneous emphysema or nasal bleeding.
","['patients undergoing bronchoscopy under moderate to deep intravenous sedation using a', ""280 patients aged ≥18 years with American Society of Anesthesiologists' physical status 1 to 3 undergoing flexible bronchoscopy were studied"", ""The 180th Hospital of People's Liberation Army, Quanzhou, China, from 1 June to 1 November 2019""]","['propofol and remifentanil', 'nasal cannula oxygenation (NCO) group (n\u200a=\u200a140) using a nasal cannula to deliver oxygen (4 l min) or the SJOV group (n\u200a=\u200a140) using a WNJ connected to a manual jet ventilator to provide SJOV at a driving pressure of 103 kPa, respiratory rate 20 min, FIO2 1.0 and inspiratory:expiratory (I:E) ratio 1:2', 'NCO', 'supraglottic jet oxygenation and ventilation (SJOV', 'propofol', 'Wei nasal jet tube (WNJ', 'Supraglottic jet oxygenation and ventilation', 'propofol, lidocaine and remifentanil cocktail']","['higher incidence of a dry mouth', 'incidence of desaturation', 'sore throat, subcutaneous emphysema or nasal bleeding', 'incidence of transient dry mouth']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006290', 'cui_str': 'Bronchoscopy'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0442192', 'cui_str': 'Supraglottic'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0038536', 'cui_str': 'Subcutaneous emphysema'}, {'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0040704', 'cui_str': 'Transients'}]",280.0,0.0671076,"There was no significant difference between the groups in respect of sore throat, subcutaneous emphysema or nasal bleeding.
","[{'ForeName': 'Benjun', 'Initials': 'B', 'LastName': 'Zha', 'Affiliation': 'From the Department of Anesthesiology, 180th Hospital of PLA, Quanzhou, China (BZ, ZW, PX, HX, LX) and Department of Anesthesiology and Critical Care, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA (HW).'}, {'ForeName': 'Zhiyun', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Huafeng', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001401']
1835,32843171,Asthma rehabilitation at high vs. low altitude and its impact on exhaled nitric oxide and sensitization patterns: Randomized parallel-group trial.,"BACKGROUND
Allergens and pollution are reduced at high altitude. We investigated the effect of asthma rehabilitation at high altitude (HA, 3100 m) compared to low altitude (LA, 760 m) on exhaled nitric oxide (FeNO) and on specific IgE levels for house dust mites (HDM,d1) and common pollen (sx1).
METHODS
For this randomized controlled trial adult asthmatics living <1000 m were randomly assigned to a 3-week in-hospital-rehabilitation (education, physical- and breathing-exercises) at either LA or HA. Changes in FeNO, d1 and sx1 from baseline to end-rehabilitation were measured.
RESULTS
50 asthmatics (34 females) were randomized [mean ± standard deviation LA: n = 25, 44 ± 11 years, total IgE 267 ± 365kU/l; HA: n = 25, 43 ± 13 years, total IgE 350 ± 445kU/l]. FeNO significantly improved at HA from 69 ± 56 ppb at baseline to the first day at altitude 23 ± 19 ppb and remained decreased until end-rehabilitation with 37 ± 23 ppb, mean difference 95%CI -31(-50 to -13, p = 0.001) whereas at LA FeNO did not change. A significant decrease in d1 and sx1 at end-rehabilitation was observed in the LA-group [mean difference 95%CI -10.2 kUA/l (-18.9 to -1.4) for d1 and -4.95 kUA/l(-9.69 to -0.21) for sx1] but not in the HA-group. No significant difference between groups [d1 5.9 kUA/l(-4.2 to 16.2) and sx1 4.4 kUA/l(-3.5 to 12.4)] was found.
CONCLUSION
Rehabilitation at HA led to significant FeNO reduction starting from the first day until end-rehabilitation despite unchanged levels of specific IgE. The significant decrease in d1 and sx1 at end-rehabilitation in the LA group might be explained by less HDM in the hospital and/or reduced seasonal pollen, as this decrease was not observed at HA.",2020,A significant decrease in d1 and sx1 at end-rehabilitation was observed in the LA-group [mean difference 95%CI -10.2 kUA/l (-18.9 to -1.4) for d1 and -4.95 kUA/l(-9.69 to -0.21) for sx1] but not in the HA-group.,"['standard deviation LA: n\xa0=\xa025, 44\xa0±\xa011 years, total IgE 267\xa0±\xa0365kU/l', 'adult asthmatics living <1000\xa0m', '50 asthmatics (34 females) were randomized [mean\xa0±', 'HA: n\xa0=\xa025, 43\xa0±\xa013 years, total IgE 350\xa0±\xa0445kU/l']","['asthma rehabilitation at high altitude (HA, 3100\xa0m) compared to low altitude (LA, 760\xa0m', 'hospital-rehabilitation (education, physical- and breathing-exercises) at either LA or HA']","['exhaled nitric oxide (FeNO) and on specific IgE levels for house dust mites (HDM,d1) and common pollen (sx1', 'FeNO', 'exhaled nitric oxide and sensitization patterns', 'specific IgE', 'd1 and sx1 at end-rehabilitation']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517735', 'cui_str': '350'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C4517705', 'cui_str': '3100'}, {'cui': 'C0238618', 'cui_str': 'Low altitude'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0998367', 'cui_str': 'House dust mite'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0032385', 'cui_str': 'Pollen'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]",,0.0858904,A significant decrease in d1 and sx1 at end-rehabilitation was observed in the LA-group [mean difference 95%CI -10.2 kUA/l (-18.9 to -1.4) for d1 and -4.95 kUA/l(-9.69 to -0.21) for sx1] but not in the HA-group.,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Basler', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Saxer', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Schneider', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Bader', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Appenzeller', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bermet', 'Initials': 'B', 'LastName': 'Estebesova', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Berik', 'Initials': 'B', 'LastName': 'Emilov', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Talant M', 'Initials': 'TM', 'LastName': 'Sooronbaev', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Guillet', 'Affiliation': 'Allergy Unit, Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid-Grendelmeier', 'Affiliation': 'Allergy Unit, Department of Dermatology, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland. Electronic address: silvia.ulrich@usz.ch.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106040']
1836,32801008,Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS
Histologic features of inflammation (histologic inflammation) are associated with clinical relapse in patients with ulcerative colitis (UC). Concentration of fecal calprotectin (FC) can be used to identify patients with mucosal inflammation. We aimed to assess the accuracy of FC measurements in identifying patients with histologic inflammation and to develop a model to predict outcomes of therapy.
METHODS
We performed a post hoc analysis of data from a phase 4 trial of the efficacy of multimatrix mesalamine in patients with mild to moderate UC (the MOMENTUM trial). We obtained clinical, endoscopic, and histologic data from week 8 (n = 639) and week 52 (n = 373) of the trial. We used area under the receiver operating characteristic curves to determine the accuracy and optimal cut-off values of FC in identifying patients with different therapeutic outcomes (clinical remission, endoscopic healing, deep remission, or histologic remission) at week 8 and week 52. We performed multivariable logistic regression analyses to identify factors associated with these outcomes.
RESULTS
Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not. FC concentrations identified patients with endoscopic healing and histologic remission with area under the receiver operating characteristic curve values of 0.77 and 0.76 at week 8, and 0.79 and 0.80 at week 52, respectively. The optimal FC cut-off concentrations for identification of patients with histologic remission were 75 μg/g at week 8 and 99 μg/g at week 52. In the subpopulation with an endoscopy score of 0, median FC concentrations were lower in patients with histologic remission than in patients with microscopic inflammation at week 8 (30 vs 140 μg/g; area under the receiver operating characteristic, 0.72) and week 52 (21.5 vs 134.5 μg/g; area under the receiver operating characteristic, 0.71). At both time points, the optimal FC cut-off concentration was approximately 75 μg/g. Our final prediction model for week 52 histologic remission comprised endoscopic score at week 8, FC concentration at week 8, and histologic activity at baseline and week 8.
CONCLUSIONS
A post hoc analysis of data from a phase 4 trial found that, even in patients with complete endoscopic healing of UC, FC concentration can be used to discriminate patients with ongoing microscopic inflammation from patients with histologic remission. The optimal cut-off concentration of FC is between 75 and 100 μg/g. ClinicalTrials.gov no: NCT01124149.",2020,"RESULTS
Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not.","['patients with mucosal inflammation', 'patients with mild to moderate UC', 'Patients With Ulcerative Colitis', 'patients with histologic inflammation', 'patients with ulcerative colitis (UC']",['multi-matrix mesalamine'],"['median FC concentrations', 'histologic activity', 'FC concentration', 'therapeutic outcomes (clinical remission, endoscopic healing, deep remission, or histologic remission', 'clinical remission, endoscopic healing, deep remission, or histologic remission', 'Median FC concentrations', 'Concentration of fecal calprotectin (FC', 'optimal FC cutoff concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",,0.0659612,"RESULTS
Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not.","[{'ForeName': 'Toer W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Gecse', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Jerrold R', 'Initials': 'JR', 'LastName': 'Turner', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'de Hertogh', 'Affiliation': 'Department of Pathology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Rubin', 'Affiliation': 'Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, Illinois.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: g.dhaens@amc.uva.nl.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.019']
1837,32805758,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,,2020,disease.,['low-risk non-muscle-invasive bladder cancer'],"['endovescical mitomycin-C versus surgical management', 'mitomycin-C vs surgical management']",[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.0445187,disease.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'Department of Urology, San Raffaele Hospital and Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Department of Urology, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",BJU international,['10.1111/bju.15214']
1838,32808888,Quantitative Muscle MRI Depicts Increased Muscle Mass after a Behavioral Change in Myotonic Dystrophy Type 1.,"Background Patients with myotonic dystrophy type 1 (DM1) increased their physical activity and exercise capacity following a behavioral intervention. However, it is unknown what is altered in muscles of patients with DM1 as a result of this intervention. The increased exercise capacity suggests that decelerated fat infiltration or increased muscle cross-sectional area (CSA) could be involved. Purpose To assess the effect of this activity-stimulating behavioral intervention on the lower extremity muscles of patients with DM1 with longitudinal quantitative muscle MRI. Materials and Methods In this prospective trial, participants with DM1 were randomized to a behavioral intervention ( n = 14) or continued regular care (standard care; n = 13); no age-matched pairing was performed. Participants underwent MRI of the lower extremities at baseline and 10-month follow-up (January 2015 to March 2016). Fat fraction (FF), muscle CSA, and muscle water T2 (T2 water ) as markers for fat infiltration, muscle mass, and alteration in tissue water distribution (edema), respectively, were assessed with a chemical shift-encoded Dixon sequence and multiecho spin-echo sequence. Longitudinal within-group and between-group changes were assessed with paired-samples t tests and multivariable regression models. Results A total of 27 patients with DM1 (15 men) were evaluated. Patient age was comparable between groups (intervention, 45 years ± 13 [standard deviation]; standard care, 5 years ± 12; P = .96). Muscle CSA increased 5.9 cm 2 ± 7.8 in the intervention group during the 10-month follow-up ( P = .03) and decreased 3.6 cm 2 ± 7.2 in the standard care group ( P = .13). After 10 months, the mean difference between the groups was 9.5 cm 2 ( P = .01). This effect was stronger in muscles with baseline FF below the mean ± standard deviation of unaffected volunteers (-0.4 cm 2 ± 0.15; P < .001). FF increased 0.9% ± 1.0 in the intervention group ( P = .02) and 1.2% ± 1.2 for standard care ( P = .02), with no between-group difference ( P = .56). T2 water did not change significantly in either group (intervention, P = .08; standard care, P = .88). Conclusion A behavioral intervention targeting physical activity increased lower extremity muscle cross-sectional area in patients with myotonic dystrophy, preferentially in healthy-appearing muscle. © RSNA, 2020 Online supplemental material is available for this article.",2020,"T2 water did not change significantly in either group (intervention, P = .08; standard care, P = .88).","[' Patients with myotonic dystrophy type 1 (DM1', 'participants with DM1', 'patients with DM1 with longitudinal quantitative muscle MRI', 'patients with myotonic dystrophy, preferentially in healthy-appearing muscle', '27 patients with DM1 (15 men']","['activity-stimulating behavioral intervention', 'behavioral intervention ( n = 14) or continued regular care (standard care; n = 13); no age-matched pairing', 'behavioral intervention targeting physical activity']","['physical activity and exercise capacity', 'Fat fraction (FF), muscle CSA, and muscle water T2 (T2 water ) as markers for fat infiltration, muscle mass, and alteration in tissue water distribution (edema', 'Muscle CSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",27.0,0.0445056,"T2 water did not change significantly in either group (intervention, P = .08; standard care, P = .88).","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Heskamp', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Okkersen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'van Nimwegen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'Ploegmakers', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bassez', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Deux', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Baziel G', 'Initials': 'BG', 'LastName': 'van Engelen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Arend', 'Initials': 'A', 'LastName': 'Heerschap', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}]",Radiology,['10.1148/radiol.2020192518']
1839,31369680,Temporal muscle thickness is an independent prognostic marker in patients with progressive glioblastoma: translational imaging analysis of the EORTC 26101 trial.,"BACKGROUND
Temporal muscle thickness (TMT) was described as a surrogate marker of skeletal muscle mass. This study aimed to evaluate the prognostic relevance of TMT in patients with progressive glioblastoma.
METHODS
TMT was analyzed on cranial MR images of 596 patients with progression of glioblastoma after radiochemotherapy enrolled in the European Organisation for Research and Treatment of Cancer 26101 trial. An optimal TMT cutoff for overall survival (OS) and progression-free survival (PFS) was defined in the training cohort (n = 260, phase II). Patients were grouped as ""below"" or ""above"" the TMT cutoff and associations with OS and PFS were tested using the Cox model adjusted for important risk factors. Findings were validated in a test cohort (n = 308, phase III).
RESULTS
An optimal baseline TMT cutoff of 7.2 mm was obtained in the training cohort for both OS and PFS (area under the curve = 0.64). Univariate analyses estimated a hazard ratio (HR) of 0.54 (95% CI: 0.42, 0.70; P < 0.0001) for OS and an HR of 0.49 (95% CI: 0.38, 0.64; P < 0.0001) for PFS for the comparison of training cohort patients above versus below the TMT cutoff. Similar results were obtained in Cox models adjusted for important risk factors with relevance in the trial for OS (HR, 0.54; 95% CI: 0.41, 0.70; P < 0.0001) and PFS (HR, 0.47; 95% CI: 0.36, 0.61; P < 0.0001). Results were confirmed in the validation cohort.
CONCLUSION
Reduced TMT is an independent negative prognostic parameter in patients with progressive glioblastoma and may help to facilitate patient management by supporting patient stratification for therapeutic interventions or clinical trials.",2019,"Univariate analyses estimated a hazard ratio (HR) of 0.54 (95% CI: 0.42, 0.70; P < 0.0001) for OS and an HR of 0.49 (95% CI: 0.38, 0.64; P < 0.0001) for PFS for the comparison of training cohort patients above versus below the TMT cutoff.","['596 patients with progression of glioblastoma after radiochemotherapy enrolled in the European Organisation for Research and Treatment of Cancer 26101 trial', 'patients with progressive glioblastoma']",['TMT'],['overall survival (OS) and progression-free survival (PFS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",596.0,0.144774,"Univariate analyses estimated a hazard ratio (HR) of 0.54 (95% CI: 0.42, 0.70; P < 0.0001) for OS and an HR of 0.49 (95% CI: 0.38, 0.64; P < 0.0001) for PFS for the comparison of training cohort patients above versus below the TMT cutoff.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Furtner', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Genbrugge', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'University Medical Center, Department of Neuroradiology, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nowosielski', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Clinical Cooperation Unit, Neuro-Oncology, German Cancer Consortium, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neurology/Neuro-Oncology, Erasmus MC-Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Preusser', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}]",Neuro-oncology,['10.1093/neuonc/noz131']
1840,32812837,Inspiratory muscle training at sea level improves the strength of inspiratory muscles during load carriage in cold-hypoxia.,"Inspiratory muscle training (IMT) and functional IMT (IMT F : exercise-specific IMT activities) has been unsuccessful in reducing respiratory muscle fatigue following load carriage. IMT F did not include load carriage specific exercises. Fifteen participants split into two groups (training and control) walked 6 km loaded (18.2 kg) at speeds representing ∼50%V̇O 2max in cold-hypoxia. The walk was completed at baseline; post 4 weeks IMT and 4 weeks IMT F (five exercises engaging core muscles, three involved load). The training group completed IMT and IMT F at a higher maximal inspiratory pressure (P imax ) than controls. Improvements in P imax were greater in the training group post-IMT (20.4%, p = .025) and post-IMT F (29.1%, p = .050) compared to controls. Respiratory muscle fatigue was unchanged ( p = .643). No other physiological or subjective measures were improved by IMT or IMT F . Both IMT and IMT F increased the strength of respiratory muscles pre-and-post a 6 km loaded walk in cold-hypoxia. Practitioner Summary: To explore the interaction between inspiratory muscle training (IMT), load carriage and environment, this study investigated 4 weeks IMT and 4 weeks functional IMT on respiratory muscle strength and fatigue. Functional IMT improved inspiratory muscle strength pre-and-post a loaded walk in cold-hypoxia but had no more effect than IMT alone. Abbreviations: ANOVA: analysis of variance; BF: breathing frequency; CON: control group; EELV: end-expiratory lung volume; EXP: experimental group; FEV 1 : forced expiratory volume in one second; FiO 2 : fraction of inspired oxygen; FVC: forced vital capacity; HR: heart rate; IMT: inspiratory muscle training; IMT F : functional inspiratory muscle training; P emax : maximal expiratory pressure; P imax : maximal inspiratory pressure; RMF: respiratory muscle fatigue; RPE: rate of perceived exertion; RWU: respiratory muscle warm-up; SaO 2 : arterial oxygen saturation; SpO 2 : peripheral oxygen saturation; V̇E: minute ventilation; V̇O 2 : rate of oxygen uptake.",2020,Both IMT and IMT F increased the strength of respiratory muscles pre-and-post a 6 km loaded walk in cold-hypoxia. ,[],"['Inspiratory muscle training (IMT) and functional IMT (IMT F : exercise-specific IMT activities', 'IMT and 4 \u2009 weeks functional IMT', 'inspiratory muscle training (IMT', 'IMT and IMT F at a higher maximal inspiratory pressure', 'Inspiratory muscle training at sea level', 'IMT']","['Respiratory muscle fatigue', 'physiological or subjective measures', 'P imax', 'respiratory muscle strength and fatigue']",[],"[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",15.0,0.0219574,Both IMT and IMT F increased the strength of respiratory muscles pre-and-post a 6 km loaded walk in cold-hypoxia. ,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hinde', 'Affiliation': 'Defence Science and Technology Laboratory, Salisbury, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Low', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lloyd', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, UK.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Cooke', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, UK.'}]",Ergonomics,['10.1080/00140139.2020.1807613']
1841,32814997,Impact of Ixekizumab on Work Productivity in Patients with Ankylosing Spondylitis: Results from the COAST-V and COAST-W Trials at 52 Weeks.,"INTRODUCTION
Patients with ankylosing spondylitis (AS) are burdened with symptoms impacting work productivity measured by presenteeism, absenteeism, overall work impairment, and activity impairment. Ixekizumab, a high-affinity monoclonal antibody selectively targeting interleukin-17A, has been demonstrated to improve disease signs and symptoms in two phase 3 trials of AS. This study investigated for 52 weeks the effect of ixekizumab treatment on work productivity in patients with active AS.
METHODS
COAST-V (NCT02696785) and COAST-W (NCT02696798) were phase 3, multicenter, randomized, controlled trials investigating the efficacy of ixekizumab 80 mg every 4 weeks (Q4W) and every 2 weeks (Q2W) in patients with AS naïve to biologic disease-modifying antirheumatic drugs (bDMARDs; COAST-V) or who were inadequate responders or intolerant to tumor necrosis factor inhibitors (TNFi; COAST-W). Work productivity was measured with the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis at weeks 16 and 52. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work. Activity impairment was assessed regardless of work status.
RESULTS
At baseline, 66.2% (434/656) of patients reported paid work. At week 16, bDMARD-naïve patients treated with both ixekizumab dose regimens and TNFi-experienced patients treated with ixekizumab Q2W reported significant improvements in activity impairment (p < 0.01 and p < 0.05, respectively). TNFi-experienced patients treated with ixekizumab showed significant improvements versus placebo in presenteeism and overall work impairment (p < 0.05); bDMARD-naïve patients had numeric improvements. After week 16, patients initially on placebo switched to ixekizumab and patients already treated with ixekizumab continued treatment. Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients.
CONCLUSION
Both bDMARD-naïve and TNFi-experienced patients with AS had greater improvements in work productivity and activity impairment when receiving ixekizumab compared to placebo at week 16. Improvements in work productivity and activity impairment achieved at week 16 were sustained through week 52 with ixekizumab treatment.",2020,"Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients.
","['Patients with ankylosing spondylitis (AS', 'Patients with Ankylosing Spondylitis', 'patients with AS naïve to biologic disease-modifying antirheumatic drugs (bDMARDs; COAST-V) or who were inadequate responders or', 'patients with active AS']","['ixekizumab treatment', 'placebo', 'intolerant to tumor necrosis factor inhibitors (TNFi; COAST-W', 'ixekizumab 80\xa0mg every 4\xa0weeks (Q4W) and every 2\xa0weeks (Q2W', 'Ixekizumab', 'ixekizumab Q2W', 'ixekizumab']","['Activity impairment', 'work productivity and daily activity', 'Work Productivity and Activity Impairment Questionnaire', 'Work Productivity', 'Work productivity', 'Absenteeism, presenteeism, and overall work impairment', 'presenteeism and overall work impairment', 'work productivity and activity impairment', 'activity impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0640566,"Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients.
","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Marzo-Ortega', 'Affiliation': 'National Institute for Health Research-Leeds Biomedical Research Centre (NIHR-LBRC), Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, West Yorkshire, UK. h.marzo-ortega@leeds.ac.uk.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center-Providence St. Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': ""Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Navarro-Compán', 'Affiliation': 'Hospital Universitario La Paz IdiPaz, Madrid, Spain.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Cochin Hospital, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Department of Rheumatology, CHU Montpellier and Montpellier University, Montpellier, France.'}, {'ForeName': 'James Cheng-Chung', 'Initials': 'JC', 'LastName': 'Wei', 'Affiliation': 'Graduate Institute of Integrated Medicine, Chung Shan Medical University, China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'St. Elisabeth Group GmbH, Herne, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hunter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sandoval', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Centre hospitalier universitaire de Québec-Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00225-4']
1842,32822131,Editorial Comment: Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,,2020,,[],"['Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia', 'Editorial Comment']",[],[],"[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.018115,,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Denstedt', 'Affiliation': 'Division of Urology, Western University, Ontario, Canada.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770.1']
1843,32822130,Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,"PURPOSE
To compare the effect of general anesthesia (GA) and regional anesthesia (RA) on f-URS outcomes and surgeon comfort.
MATERIAL AND METHODS
The study was conducted between June 2017 to January 2018 and data collection was applied in a prospective, randomized fashion. 120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64). Demographic, operative and post-operative parameters of patients were analysed. The end point of this study was the effect of two anesthesia regimens on the comfort of the surgeon, and the comparability of feasibility and safety against perioperative complications.
RESULTS
The study including 120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group). No difference was detected between the two groups in terms of preoperative data. During the monitorization of operative vital signs, 3 patients in RA group experienced bradycardia, and this finding was significant when compared with GA group (p=0.041). Additionally, 2 patients in RA group experienced mucosal tears and 1 patient experienced hemorrhage during the operation, but no complications were observed in the GA group (p=0.041). Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
CONCLUSIONS
Both GA and RA are equally effective and safe anesthesia methods for f-URS procedures. However, RA group showed significantly increased likelihood of bradycardia and mucosal injury during surgery, and significantly decreased surgeon comfort during surgery.",2020,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","['June 2017 to January 2018 and data collection', '120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group', '120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64']","['general anesthesia (GA) and regional anesthesia (RA', 'Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia']","['bradycardia', 'likelihood of bradycardia and mucosal injury', 'surgeon comfort', 'mucosal tears and 1 patient experienced hemorrhage']","[{'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",120.0,0.0376006,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sahan', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Sarilar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Fatih', 'Initials': 'MF', 'LastName': 'Akbulut', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Demir', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Savun', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Oznur', 'Initials': 'O', 'LastName': 'Sen', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Ozgor', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770']
1844,32822141,"Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial.",,2020,,['prostate cancer'],['Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.109669,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.06.09']
1845,32824722,The Impact of a Multi-Pronged Intervention on Students' Perceptions of School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption.,"School lunch programs provide an opportunity to improve students' diets. We sought to determine the impact of a multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education) on secondary students' perceptions of school-lunch quality and convenience and fruit and vegetable intake. Surveys ( n = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed. We investigated change in school-lunch perceptions and lunchtime and daily fruit and vegetable consumption from 2016 to 2018. Among 8th graders, perceptions that school lunch tastes good and that school lunch was enough to make students feel full increased 0.2 points (on a 5-point scale; p < 0.01) in intervention schools relative to control schools. Among 10th graders, lunchtime fruit and vegetable consumption increased 6% in intervention relative to control schools ( p < 0.05 and p < 0.01 respectively). Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p < 0.01). This study provides important evidence on the limited effect of design approaches in the absence of meal changes. We observed only modest changes in school lunch perceptions and fruit and vegetable consumption that were not consistent across grades, suggesting that additional efforts are needed to improve school-lunch uptake.",2020,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p < 0.01).,"['Surveys ( n = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed', ""students' diets""]","['Multi-Pronged Intervention', 'multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education']","['lunchtime fruit and vegetable consumption', 'school-lunch uptake', 'Daily fruit intake', 'school-lunch perceptions and lunchtime and daily fruit and vegetable consumption', 'school lunch perceptions and fruit and vegetable consumption', 'school-lunch quality and convenience and fruit and vegetable intake', 'School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0871930', 'cui_str': 'Teacher Education'}]","[{'cui': 'C0585039', 'cui_str': 'Lunch time'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0183678,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p < 0.01).,"[{'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Machado', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Lorrene D', 'Initials': 'LD', 'LastName': 'Ritchie', 'Affiliation': 'Nutrition Policy Institute, University of California Agriculture and Natural Resources, Berkeley, CA 94704, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Thompson', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Madsen', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17165987']
1846,32824771,High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation in Hypercapnic Respiratory Failure: A Randomized Clinical Trial.,"High-flow oxygen through nasal cannula (HFNC) provides adequate oxygenation and can be an alternative to noninvasive ventilation (NIV) for patients with hypoxemic respiratory failure. The aim of the present study was to assess the efficacy of HFNC versus NIV in hypercapnic respiratory failure. Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2 ≥ 45 mmHg) were randomized assigned into two groups, i.e., an intervention group (use of HFNC, n = 20) and a control group (use of NIV, n = 20). During their hospitalization in the Intensive Care Unit, vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG) were closely monitored on admission, after 24 h and at discharge. No difference between the two groups regarding the duration of hospitalization and the use of HFNC or NIV was observed ( p > 0.05). On admission, the two groups did not differ in terms of gender, age, body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases ( p > 0.05). Respiratory rate in the HFNC group was lower than in the NIV group ( p = 0.023). At discharge, partial carbon dioxide arterial pressure (PaCO 2 ) in the HFNC group was lower than in the NIV group (50.8 ± 9.4 mmHg versus 59.6 ± 13.9 mmHg, p = 0.024). The lowerPaCO 2 in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.",2020,The lowerPaCO 2 in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"['patients with hypoxemic respiratory failure', '45 mmHg', 'Hypercapnic Respiratory Failure', 'hypercapnic respiratory failure', 'Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2 ≥']","['High-flow oxygen through nasal cannula (HFNC', 'High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation', 'HFNC']","['partial carbon dioxide arterial pressure (PaCO 2 ', 'duration of hospitalization and the use of HFNC or NIV', 'vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG', 'body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases', 'Respiratory rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0542864,The lowerPaCO 2 in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"[{'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Papachatzakis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Occupational Therapy, School of Health and Caring Sciences, University of West Attica, 12243 Athens, Greece.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Kontogiannis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Trakada', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}]",International journal of environmental research and public health,['10.3390/ijerph17165994']
1847,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and design of a cluster-randomized trial.,"BACKGROUND
The Systolic Blood Pressure Intervention Trial (SPRINT) reported that intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS
Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center clinics in Louisiana and Mississippi. Federally Qualified Health Center clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0-mm Hg difference in systolic BP at a .05 significance level and 80% follow-up rate.
CONCLUSIONS
IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the United States.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, New Orleans, LA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, LA; Department of Medicine, Tulane University School of Medicine, New Orleans, LA; Tulane University Translational Sciences Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
1848,32828135,Hydroxychloroquine in the Treatment of COVID-19: A Multicenter Randomized Controlled Study.,"The COVID-19 pandemic is showing an exponential growth, mandating an urgent need to develop an effective treatment. Indeed, to date, a well-established therapy is still lacking. We aimed to evaluate the safety and efficacy of hydroxychloroquine (HCQ) added to standard care in patients with COVID-19. This was a multicenter, randomized controlled trial conducted at three major university hospitals in Egypt. One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent. They were equally randomized into two arms: 97 patients administrated HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group). The primary endpoints were recovery within 28 days, need for mechanical ventilation, or death. The two groups were matched for age and gender. There was no significant difference between them regarding any of the baseline characteristics or laboratory parameters. Four patients (4.1%) in the HCQ group and 5 (5.2%) patients in the control group needed mechanical ventilation ( P = 0.75). The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P = 0.77). Univariate logistic regression analysis showed that HCQ treatment was not significantly associated with decreased mortality in COVID-19 patients. So, adding HCQ to standard care did not add significant benefit, did not decrease the need for ventilation, and did not reduce mortality rates in COVID-19 patients.",2020,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P = 0.77).","['patients with COVID-19', 'COVID-19', 'three major university hospitals in Egypt', 'One hundred ninety-four patients with confirmed diagnosis of COVID-19 were included in the study after signing informed consent']","['HCQ plus standard care (HCQ group) and 97 patients administered only standard care as a control arm (control group', 'Hydroxychloroquine', 'hydroxychloroquine (HCQ', 'HCQ']","['mechanical ventilation', 'mortality rates', 'safety and efficacy', 'recovery within 28 days, need for mechanical ventilation, or death', 'overall mortality', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",194.0,0.126559,"The overall mortality did not differ between the two groups, as six patients (6.2%) died in the HCQ group and 5 (5.2%) died in the control group ( P = 0.77).","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Eslam Saber', 'Initials': 'ES', 'LastName': 'Esmail', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Khalaf', 'Affiliation': 'Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ehab Fawzy', 'Initials': 'EF', 'LastName': 'Abdo', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Medhat', 'Affiliation': 'Department of Gastroenterology and Tropical Medicine, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed Samir', 'Initials': 'MS', 'LastName': 'Abd El Ghafar', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ossama Ashraf', 'Initials': 'OA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Internal Medicine, Ain-Shams University, Cairo, Egypt.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public Health and Community Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Ghada N', 'Initials': 'GN', 'LastName': 'Serangawy', 'Affiliation': 'Department of Forensic Medicine and Toxicology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alboraie', 'Affiliation': 'Department of Internal Medicine, Al-Azhar University, Cairo, Egypt.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0873']
1849,32828880,"SCORE2 Report 13: Intraretinal Hemorrhage Changes in Eyes With Central or Hemiretinal Vein Occlusion Managed With Aflibercept, Bevacizumab or Observation. Secondary Analysis of the SCORE and SCORE2 Clinical Trials.","PURPOSE
To investigate the relationship between intraretinal macular hemorrhage and visual acuity outcomes in eyes with central retinal vein occlusion or hemiretinal vein occlusion managed with aflibercept, bevacizumab, or observation.
DESIGN
Retrospective analysis of data from 2 randomized clinical trials.
METHODS
A total of 362 participants were randomized in the Study of Comparative Treatments for Retinal Vein Occlusion 2, and 88 participants randomized to observation in the Standard Care vs Corticosteroid in Retinal Vein Occlusion Study. Participants received monthly intravitreal aflibercept or bevacizumab through month 6 or observation through month 8. The main outcome was visual acuity letter score (VALS).
RESULTS
Reduced area of hemorrhage by month 6 was observed in 70.7% (116 of 164) of aflibercept-treated eyes, 63.8% (104 of 163) of bevacizumab-treated eyes, and 42.2% (27 of 64) of observation eyes by month 8 (P < .01). Relative to eyes with hemorrhage during follow-up, aflibercept-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 8.0 (99% confidence interval [CI]: 1.9, 14.2); bevacizumab-treated eyes without hemorrhage at month 6 had a mean VALS improvement of 3.2 (99% CI: -4.6, 11.0); and observation eyes without hemorrhage at month 8 had a mean VALS improvement of 13.5 (99% CI: 0.4, 26.5). At month 6, the presence of hemorrhage and the change in central subfield thickness (CST) were significantly associated with the change in VALS; however, CST was a more important predictor.
CONCLUSION
Improvement in hemorrhage during follow-up was associated with visual acuity improvements and predicted visual acuity changes beyond what was explained by CST. These findings suggest that intraretinal macular hemorrhage is an important indicator of disease severity in retinal vein occlusion.",2020,"RESULTS
Reduced area of hemorrhage by Month 6 was observed in 70.7% (116/164) of aflibercept-treated eyes, 63.8% (104/163) of bevacizumab-treated eyes, and 42.2% (27/64) of observation eyes by Month 8 (P<0.01).","['362 participants', 'eyes with CRVO or HRVO managed with', 'Eyes with Central or Hemiretinal Vein Occlusion']","['Standard Care versus COrticosteroid', 'Aflibercept, Bevacizumab or Observation', 'bevacizumab', 'CST', 'REtinal Vein Occlusion', 'intravitreal aflibercept or bevacizumab', 'aflibercept, bevacizumab, or observation']","['visual acuity letter score (VALS', 'visual acuity improvements and predicted visual acuity changes', 'intraretinal macular hemorrhage and visual acuity outcomes', 'presence of hemorrhage and change in central subfield thickness (CST', 'area of hemorrhage', 'mean VALS improvement']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1735356', 'cui_str': 'Hemiretinal vein occlusion'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0035328', 'cui_str': 'Retinal vein occlusion'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",362.0,0.313113,"RESULTS
Reduced area of hemorrhage by Month 6 was observed in 70.7% (116/164) of aflibercept-treated eyes, 63.8% (104/163) of bevacizumab-treated eyes, and 42.2% (27/64) of observation eyes by Month 8 (P<0.01).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hendrick', 'Affiliation': 'Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'VanVeldhuisen', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland, USA. Electronic address: score2@emmes.com.'}, {'ForeName': 'Ingrid U', 'Initials': 'IU', 'LastName': 'Scott', 'Affiliation': 'Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Blodi', 'Affiliation': 'University of Wisconsin Fundus Photograph Reading Center, Madison, Wisconsin, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Ip', 'Affiliation': 'Doheny Eye Institute, University of California, Los Angeles, California, USA.'}, {'ForeName': 'Rahul N', 'Initials': 'RN', 'LastName': 'Khurana', 'Affiliation': 'Northern California Retina Vitreous Associates, Mountain View, California, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Oden', 'Affiliation': 'The Emmes Company, LLC, Rockville, Maryland, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.030']
1850,32829739,Advancement of a standardised enteral feeding protocol in functional single ventricle patients following stage I palliation using cerebro-somatic near-infrared spectroscopy.,"INTRODUCTION
Infants with single ventricle following stage I palliation are at risk for poor nutrition and growth failure. We hypothesise a standardised enteral feeding protocol for these infants that will result in a more rapid attainment of nutritional goals without an increased incidence of gastrointestinal co-morbidities.
MATERIALS AND METHODS
Single-centre cardiac ICU, prospective case series with historical comparisons. Feeding cohort consisted of consecutive patients with a single ventricle admitted to cardiac ICU over 18 months following stage I palliation (n = 33). Data were compared with a control cohort and admitted to the cardiac ICU over 18 months before feeding protocol implementation (n = 30). Feeding protocol patients were randomised: (1) protocol with cerebro-somatic near-infrared spectroscopy feeding advancement criteria (n = 17) or (2) protocol without cerebro-somatic near-infrared spectroscopy feeding advancement criteria (n = 16).
RESULTS
Median time to achieve goal enteral volume was significantly higher in the control compared to feeding cohort. There were no significant differences in enteral feeds being held for feeding intolerance or necrotising enterocolitis between cohorts. Feeding cohort had significant improvements in discharge nutritional status (weight, difference admit to discharge weight, weight-for-age z score, volume, and caloric enteral nutrition) and late mortality compared to the control cohort. No infants in the feeding group with cerebro-somatic near-infrared spectroscopy developed necrotising enterocolitis versus 4/16 (25%) in the feeding cohort without cerebro-somatic near-infrared spectroscopy (p = 0.04).
CONCLUSIONS
A feeding protocol is a safe and effective means of initiating and advancing enteral nutrition in infants following stage I palliation and resulted in improved nutrition delivery, weight gain, and nourishment status at discharge without increased incidence of gastrointestinal co-morbidities.",2020,There were no significant differences in enteral feeds being held for feeding intolerance or necrotising enterocolitis between cohorts.,"['functional single ventricle patients following stage I palliation using cerebro-somatic near-infrared spectroscopy', 'Infants with single ventricle following stage', 'consecutive patients with a single ventricle admitted to cardiac ICU over 18 months following stage I palliation (n = 33']","['standardised enteral feeding protocol', 'protocol with cerebro-somatic near-infrared spectroscopy feeding advancement criteria (n = 17) or (2) protocol without cerebro-somatic near-infrared spectroscopy feeding advancement criteria']","['discharge nutritional status (weight, difference admit to discharge weight, weight-for-age z score, volume, and caloric enteral nutrition) and late mortality', 'Median time to achieve goal enteral volume', 'necrotising enterocolitis']","[{'cui': 'C2732741', 'cui_str': 'Functional single ventricle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152424', 'cui_str': 'Common ventricle'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0441478', 'cui_str': 'Surgical advancement - action'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272277', 'cui_str': 'Goal achieved'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}]",33.0,0.0458667,There were no significant differences in enteral feeds being held for feeding intolerance or necrotising enterocolitis between cohorts.,"[{'ForeName': 'Tia T', 'Initials': 'TT', 'LastName': 'Raymond', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Selena', 'Initials': 'S', 'LastName': 'Valle', 'Affiliation': ""HCA Research Institute at Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Garza', 'Affiliation': ""Children's Health, Division of Cardiology, Dallas, TX, USA.""}, {'ForeName': 'Samrat', 'Initials': 'S', 'LastName': 'Yeramaneni', 'Affiliation': ""HCA Research Institute at Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Wurtz', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Sample', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kozak', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stigall', 'Affiliation': ""Pediatric Critical Care, Cook Children's Hospital, Fort Worth, TX, USA.""}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gatlin', 'Affiliation': ""Department of Pediatrics, Division of Cardiology, Arkansas Children's Hospital, Little Rock, AR, USA.""}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Burton', 'Affiliation': ""Department of Pediatrics, Cardiac Intensive Care, Medical City Children's Hospital, Dallas, TX, USA.""}]",Cardiology in the young,['10.1017/S104795112000253X']
1851,32857992,"Immunogenicity of a single-dose compared with a two-dose primary series followed by a booster dose of ten-valent or 13-valent pneumococcal conjugate vaccine in South African children: an open-label, randomised, non-inferiority trial.","BACKGROUND
Routine childhood immunisation with pneumococcal conjugate vaccine (PCV) has changed the epidemiology of pneumococcal disease across age groups, providing an opportunity to reconsider PCV dosing schedules. We aimed to evaluate the post-booster dose immunogenicity of ten-valent (PCV10) and 13-valent (PCV13) PCVs between infants randomly assigned to receive a single-dose compared with a two-dose primary series.
METHODS
We did an open-label, non-inferiority, randomised study in HIV-unexposed infants at a single centre in Soweto, South Africa. Infants were randomly assigned to receive one priming dose of PCV10 or PCV13 at ages 6 weeks (6w + 1 PCV10 and 6w + 1 PCV13 groups) or 14 weeks (14w + 1 PCV10 and 14w + 1 PCV13 groups) or two priming doses of PCV10 or PCV13, one each at ages 6 weeks and 14 weeks (2 + 1 PCV10 and 2 + 1 PCV13 groups); all participants then received a booster dose of PCV10 or PCV13 at 40 weeks of age. The primary endpoint was geometric mean concentrations (GMCs) of serotype-specific IgG 1 month after the booster dose, which was assessed in all participants who received PCV10 or PCV13 as per the assigned randomisation group and for whom laboratory results were available at that timepoint. The 1 + 1 vaccine schedule was considered non-inferior to the 2 + 1 vaccine schedule if the lower bound of the 96% CI for the GMC ratio was greater than 0·5 for at least ten PCV13 serotypes and eight PCV10 serotypes. Safety was a secondary endpoint. This trial is registered with ClinicalTrials.gov (NCT02943902) and is ongoing.
FINDINGS
Of 1695 children assessed, 600 were enrolled and randomly assigned to one of the six groups between Jan 9 and Sept 20, 2017; 542 were included in the final analysis of the primary endpoint (86-93 per group). For both PCV13 and PCV10, a 1+1 dosing schedule (either beginning at 6 or 14 weeks) was non-inferior to a 2 + 1 schedule. For PCV13, the lower limit of the 96% CI for the ratio of GMCs between the 1 + 1 and 2 + 1 groups was higher than 0·5 for ten serotypes in the 6w+1 group (excluding 6B, 14, and 23F) and 11 serotypes in the 14w + 1 group (excluding 6B and 23F). For PCV10, the lower limit of the 96% CI for the ratio of GMCs was higher than 0·5 for all ten serotypes in the 6w+1 and 14w + 1 groups. 84 serious adverse events were reported in 72 (12%) of 600 participants. 15 occurred within 28 days of vaccination, but none were considered to be related to PCV injection. There were no cases of culture-confirmed invasive pneumococcal disease.
INTERPRETATION
The non-inferiority in post-booster immune responses following a single-dose compared with a two-dose primary series of PCV13 or PCV10 indicates the potential for reducing PCV dosing schedules from a 2 + 1 to 1 + 1 series in low-income and middle-income settings with well established PCV immunisation programmes.
FUNDING
The Bill & Melinda Gates Foundation (OPP1 + 152352).",2020,84 serious adverse events were reported in 72 (12%) of 600 participants.,"['HIV-unexposed infants at a single centre in Soweto, South Africa', 'South African children', 'Of 1695 children assessed, 600 were enrolled and randomly assigned to one of the six groups between Jan 9 and Sept 20, 2017; 542 were included in the final analysis of the primary endpoint (86-93 per group']","['valent or 13-valent pneumococcal conjugate vaccine', 'pneumococcal conjugate vaccine (PCV', 'PCV10 or PCV13', 'ten-valent (PCV10) and 13-valent (PCV13) PCVs']","['84 serious adverse events', 'geometric mean concentrations (GMCs) of serotype-specific IgG 1 month', 'GMC ratio', 'Immunogenicity', 'ratio of GMCs']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C3152625', 'cui_str': 'Pneumococcal 13-valent conjugate vaccine'}, {'cui': 'C1579319', 'cui_str': 'Pneumococcal conjugate vaccine'}, {'cui': 'C3849486', 'cui_str': '10-valent pneumococcal conjugate vaccine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036759', 'cui_str': 'Serotyping'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",600.0,0.279769,84 serious adverse events were reported in 72 (12%) of 600 participants.,"[{'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa. Electronic address: madhis@rmpru.co.za.'}, {'ForeName': 'Eleonora Aml', 'Initials': 'EA', 'LastName': 'Mutsaerts', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Welekazi', 'Initials': 'W', 'LastName': 'Boyce', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Sutika', 'Initials': 'S', 'LastName': 'Bhikha', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Benit T', 'Initials': 'BT', 'LastName': 'Ikulinda', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Nana', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moultrie', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Roalfe', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Immunobiology Section, University College London, Great Ormond Street Institute of Child Health Biomedical Research Centre, London, UK.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Dorfman', 'Affiliation': 'South African Medical Research Council Vaccines and Infectious Diseases Analytical Research Unit, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa; Department of Science, National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30289-9']
1852,32862662,Initial Invasive Versus Conservative Management of Stable Ischemic Heart Disease in Patients With a History of Heart Failure or Left Ventricular Dysfunction: Insights From the ISCHEMIA Trial.,"BACKGROUND
Whether an initial invasive strategy in patients with stable ischemic heart disease and at least moderate ischemia improves outcomes in the setting of a history of heart failure (HF) or left ventricular dysfunction (LVD) when ejection fraction is ≥35% but <45% is unknown.
METHODS
Among 5179 participants randomized into ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), all of whom had left ventricular ejection fraction (LVEF) ≥35%, we compared cardiovascular outcomes by treatment strategy in participants with a history of HF/LVD at baseline versus those without HF/LVD. Median follow-up was 3.2 years.
RESULTS
There were 398 (7.7%) participants with HF/LVD at baseline, of whom 177 had HF/LVEF >45%, 28 HF/LVEF 35% to 45%, and 193 LVEF 35% to 45% but no history of HF. HF/LVD was associated with more comorbidities at baseline, particularly previous myocardial infarction, stroke, and hypertension. Compared with patients without HF/LVD, participants with HF/LVD were more likely to experience a primary outcome composite of cardiovascular death, nonfatal myocardial infarction, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest (4-year cumulative incidence rate, 22.7% versus 13.8%; cardiovascular death or myocardial infarction, 19.7% versus 12.3%; and all-cause death or HF, 15.0% versus 6.9%). Participants with HF/LVD randomized to the invasive versus conservative strategy had a lower rate of the primary outcome (17.2% versus 29.3%; difference in 4-year event rate, -12.1% [95% CI, -22.6 to -1.6%]), whereas those without HF/LVD did not (13.0% versus 14.6%; difference in 4-year event rate, -1.6% [95% CI, -3.8% to 0.7%]; P interaction = 0.055). A similar differential effect was seen for the primary outcome, all-cause mortality, and cardiovascular mortality when invasive versus conservative strategy-associated outcomes were analyzed with LVEF as a continuous variable for patients with and without previous HF.
CONCLUSIONS
ISCHEMIA participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD were at increased risk for the primary outcome. In the small, high-risk subgroup with HF and LVEF 35% to 45%, an initial invasive approach was associated with better event-free survival. This result should be considered hypothesis-generating. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.",2020,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","['5179 participants', 'Stable Ischemic Heart Disease Patients with a History of Heart Failure or Left Ventricular Dysfunction', 'participants with stable ischemic heart disease and at least moderate ischemia with a history of HF or LVD', 'patients with stable ischemic heart disease', 'patients with a history of heart failure (HF) or left ventricular dysfunction (LVD']",['Initial Invasive versus Conservative Management'],"['better event-free survival', 'cardiovascular death or MI', 'cause mortality, and CV mortality', 'cardiovascular death, nonfatal MI, or hospitalization for unstable angina, HF, or resuscitated cardiac arrest; four-year cumulative incidence rate', 'myocardial infarction (MI), stroke and hypertension']","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0242698', 'cui_str': 'Impaired left ventricular function'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",5179.0,0.202193,"HF/LVD was associated with more comorbidities at baseline, particularly prior myocardial infarction (MI), stroke and hypertension.","[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke University Medical Center, Durham, NC (R.D.L., M.K.).'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., S.R.S., F.W.R.).'}, {'ForeName': 'Susanna R', 'Initials': 'SR', 'LastName': 'Stevens', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., S.R.S., F.W.R.).'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'NYU Grossman School of Medicine, New York (H.R.R., J.S.H.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Cardiovascular Research Foundation, New York (G.W.S.).'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Wayne State University/Central Michigan University, Detroit (I.L.P.).'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (K.P.A., S.R.S., F.W.R.).'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elghamaz', 'Affiliation': 'Northwick Park Hospital-Royal Brompton Hospital, London, UK (A.E.).'}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Lopez-Sendon', 'Affiliation': 'Hospital Universitario La Paz, IdiPaz, CIBER-CV, Madrid, Spain (J.L.L.-S.).'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Farsky', 'Affiliation': 'Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil (P.S.F.).'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Chernyavskiy', 'Affiliation': 'E. Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation, Moscow, Russia (A.M.C.).'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Diaz', 'Affiliation': 'CIUSSS-MCQ, University of Montreal, Campus Mauricie, Trois-Rivieres, Canada (A.D.).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Phaneuf', 'Affiliation': 'Hôpital Pierre-Le Gardeur, Quebec, Canada (D.P.).'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'De Belder', 'Affiliation': 'Barts Health NHS Trust, London, UK (M.A.D.).'}, {'ForeName': 'Yi-Tong', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'First Affiliated Hospital of Xinjiang Medical University, Urumqi, China (Y.-t.M.).'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Guzman', 'Affiliation': 'DAMIC Medical Institute, Cordoba, Argentina (L.A.G.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Khouri', 'Affiliation': 'Duke University Medical Center, Durham, NC (R.D.L., M.K.).'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sionis', 'Affiliation': 'Intensive Cardiac Care Unit, Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-Sant Pau, CIBER-CV, Universitat Autònoma de Barcelona, Spain (A.S.).'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Hausenloy', 'Affiliation': 'The Hatter Cardiovascular Institute, Institute of Cardiovascular Sciences, University College London, UK (D.J.H.).'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Doerr', 'Affiliation': 'Praxisklinik Herz und Gefaesse, Dresden, Germany (R.D.).'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Selvanayagam', 'Affiliation': 'Flinders Medical Centre, Adelaide, Australia (J.B.S.).'}, {'ForeName': 'Aldo Pietro', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy (A.P.M.).'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'NYU Grossman School of Medicine, New York (H.R.R., J.S.H.).'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Maron', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, CA (D.J.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.120.050304']
1853,32811715,Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors.,"BACKGROUND
The phase 3 trial CA184-043 evaluated radiotherapy to bone metastases followed by Ipilimumab or placebo in men with metastatic castrate-resistant prostate cancer (mCRPC) who had received docetaxel previously. In a prior analysis, the trial's primary endpoint (overall survival [OS]) was not improved significantly.
OBJECTIVE
To report the final analysis of OS.
DESIGN, SETTING, AND PARTICIPANTS
A total of 799 patients were randomized to receive a single dose of radiotherapy to one or more bone metastases followed by either Ipilimumab (n = 399) or placebo (n = 400).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
OS was analyzed in the intention-to-treat population. Prespecified and exploratory subset analyses based on Kaplan-Meier/Cox methodology were performed.
RESULTS AND LIMITATIONS
During an additional follow-up of approximately 2.4 yr since the primary analysis, 721/799 patients have died. Survival analysis showed crossing of the curves at 7-8 mo, followed by persistent separation of the curves beyond that point, favoring the ipilimumab arm. Given the lack of proportional hazards, a piecewise hazard model showed that the hazard ratio (HR) changed over time: the HR was 1.49 (95% confidence interval 1.12, 1.99) for 0-5 mo, 0.66 (0.51, 0.86) for 5-12 mo, and 0.66 (0.52, 0.84) beyond 12 mo. OS rates were higher in the ipilimumab versus placebo arms at 2 yr (25.2% vs 16.6%), 3 yr (15.3% vs 7.9%), 4 yr (10.1% vs 3.3%), and 5 yr (7.9% vs. 2.7%). Disease progression was the most frequent cause of death in both arms. In seven patients (1.8%) in the ipilimumab arm and one (0.3%) in the placebo arm, the primary cause of death was reported as study drug toxicity. No long-term safety signals were identified.
CONCLUSIONS
In this preplanned long-term analysis, OS favored ipilimumab plus radiotherapy versus placebo plus radiotherapy for patients with postdocetaxel mCRPC. OS rates at 3, 4, and 5 yr were approximately two to three times higher in the ipilimumab arm.
PATIENT SUMMARY
After longer follow-up, survival favored the group of men who received ipilimumab, with overall survival rates being two to three times higher at 3 yr and beyond.",2020,"After longer follow-up, survival favored the group of men who received ipilimumab, with overall survival rates being two to three times higher at 3 yr and beyond.","['patients with postdocetaxel mCRPC', 'A total of 799 patients', 'men with metastatic castrate-resistant prostate cancer (mCRPC) who had received docetaxel previously']","['radiotherapy to one or more bone metastases followed by either Ipilimumab', 'Ipilimumab Versus Placebo', 'ipilimumab plus radiotherapy', 'placebo plus radiotherapy', 'Ipilimumab or placebo', 'ipilimumab', 'placebo']","['OS rates', 'death', 'survival', 'hazard ratio (HR', 'study drug toxicity', 'overall survival rates', 'overall survival [OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",799.0,0.666508,"After longer follow-up, survival favored the group of men who received ipilimumab, with overall survival rates being two to three times higher at 3 yr and beyond.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA.'}, {'ForeName': 'Eugene D', 'Initials': 'ED', 'LastName': 'Kwon', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, USA; Weill-Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Winald R', 'Initials': 'WR', 'LastName': 'Gerritsen', 'Affiliation': 'Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bossi', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Alfons J M van', 'Initials': 'AJMV', 'LastName': 'den Eertwegh', 'Affiliation': 'VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krainer', 'Affiliation': 'Vienna General Hospital (AKH Wien), Wien, Austria.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Houede', 'Affiliation': 'CHU of Nimes, Nimes, France; Montpellier University, Montpellier, France.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Santos', 'Affiliation': 'Centro Médico Austral, Buenos Aires, Argentina.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Mahammedi', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'St John Of God Hospital, Subiaco, Australia.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Danielli', 'Affiliation': 'University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Franke', 'Affiliation': 'Hospital de Caridade de Ijuí, Ijuí, Brazil.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'André M', 'Initials': 'AM', 'LastName': 'Bergman', 'Affiliation': 'The Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Tudor E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Institute of Oncology Ion Chiricuta, Cluj-Napoca, Romania.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Korbenfeld', 'Affiliation': 'Hospital Britanico de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sengeløv', 'Affiliation': 'Herlev Hospital, Region Hovedstadens Apotek, Herlev, Denmark.'}, {'ForeName': 'Steinbjorn', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb Company, Wallingford, CT, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Bristol-Myers Squibb Company, Wallingford, CT, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.07.032']
1854,32814339,Effects of Vibration Training in Interstitial Lung Diseases: A Randomized Controlled Trial.,"BACKGROUND
Numerous studies have reported positive effects of exercise training in patients with interstitial lung disease (ILD) on physical capacity and quality of life. However, evidence is rare on the effects of specific forms of training and further pathophysiological mechanisms in these patients.
OBJECTIVES
In this multicenter study we aimed to explore the clinical effects of whole-body vibration training (WBVT) in patients with ILD on various outcome measures, including proinflammatory cytokines and myostatin.
METHODS
We randomly assigned 26 patients with different forms of multidisciplinary confirmed fibrotic ILDs either to the WBVT group (n = 11; 55% male, 61 ± 14 years old, forced vital capacity 83.2 ± 29.3% predicted, 6-min walking distance [6MWD] 478 ± 79 m) performing 3 months of a standardized training (3 times per week), or to a control training group (CTG, n = 15; 60% male, 63 ± 9 years old, FVC 74.6 ± 20.5% predicted, 6MWD 455 ± 85 m) performing sham WBV training. Training in the two groups was performed on a GalileoTM vibration plate (6-20 vs. 5 Hz). The functional assessments before and after the intervention period included pulmonary function, 6MWD test, chair rise test, ultrasonographic measurement of quadriceps muscle thickness (cross-sectional area), quality of life questionnaires, and serum samples.
RESULTS
We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL [-713 to -166], p = 0.008) in the WBVT group. In contrast, no significant differences were observed in the CTG.
CONCLUSIONS
The present study demonstrates that WBVT is able to significantly increase 6MWD and decrease myostatin in patients with fibrotic ILDs. Therefore, WBVT seems to be a beneficial and feasible training modality in ILD patients. Clinical Trial Registry: German Clinical Trials Registry (DRKS00012930).",2020,"We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL","['Interstitial Lung Diseases', 'ILD patients', '26 patients with different forms of multidisciplinary confirmed fibrotic ILDs either to the WBVT group (n = 11; 55% male, 61 ± 14 years old, forced vital capacity 83.2 ± 29.3% predicted, 6-min walking distance', 'patients with interstitial lung disease (ILD', 'patients with fibrotic ILDs', 'patients with ILD']","['WBVT', 'exercise training', 'control training', 'GalileoTM vibration plate', 'whole-body vibration training (WBVT', 'sham WBV training', 'Vibration Training']","['pulmonary function, 6MWD test, chair rise test, ultrasonographic measurement of quadriceps muscle thickness (cross-sectional area), quality of life questionnaires, and serum samples', 'proinflammatory cytokines and myostatin', '6MWD']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}]",26.0,0.0300793,"We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL","[{'ForeName': 'Andreas Rembert', 'Initials': 'AR', 'LastName': 'Koczulla', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Boeselt', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Koelpin', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Kaufhold', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Veith', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nell', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany, ijarosch@schoen-klinik.de.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Spielmanns', 'Affiliation': 'Pulmonology, Zuercher Reha Zentrum Wald, Wald, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alter', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kähler', 'Affiliation': 'Pneumology SKB, Private Clinic Kettenbruecke, Innsbruck, Austria.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Greulich', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Glöckl', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kenn', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Nicolas Carlos', 'Initials': 'NC', 'LastName': 'Kahn', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix J F', 'Initials': 'FJF', 'LastName': 'Herth', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}]",Respiration; international review of thoracic diseases,['10.1159/000508977']
1855,32819842,Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa.,"RESEARCH QUESTION
The objective of this investigation was to determine the daily follitropin delta dose (µg) providing a similar ovarian response to 150 IU/day follitropin alfa.
DESIGN
The study was a post-hoc analysis of ovarian response in 1591 IVF/intracytoplasmic sperm injection (ICSI) patients undergoing ovarian stimulation in a gonadotrophin-releasing hormone antagonist protocol in two recent randomized, assessor-blind, controlled trials in the development programme for follitropin delta: a phase II dose-response trial with a reference arm of a fixed daily dose of 150 IU follitropin alfa throughout stimulation, and a phase III efficacy trial with a comparator arm of 150 IU/day follitropin alfa as a starting dose.
RESULTS
Daily follitropin delta doses of 10.0 µg (95% confidence interval [CI] 7.9-12.8) and 10.3 µg (95% CI 9.7-10.8) yielded the same number of oocytes as 150 IU/day follitropin alfa for all patients participating in the phase II and III trials, respectively. When analysing patients with either normal or high ovarian reserve (based on serum anti-Mullerian hormone ≥15 pmol/l) and no dose changes, the same number of oocytes was obtained with 150 IU/day follitropin alfa and daily doses of follitropin delta of 9.7 µg (95% CI 7.5-12.4) and 9.3 µg (95% CI 8.6-10.1) in the two trials. Daily follitropin delta doses in the range 9.5-10.4 µg were consistently estimated to correspond to 150 IU/day follitropin alfa for serum oestradiol concentration and number of follicles ≥12 mm at the end of stimulation across analysis populations in the phase III trial.
CONCLUSIONS
A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.",2020,A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.,"['1591 IVF/intracytoplasmic sperm injection (ICSI) patients undergoing ovarian stimulation in a', 'IVF/ICSI patients']","['gonadotrophin-releasing hormone antagonist protocol', 'daily follitropin delta dose (µg) providing a similar ovarian response to 150\xa0IU/day follitropin alfa']",['ovarian response'],"[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C1268876', 'cui_str': 'Follitropin Alfa'}]",[],,0.407696,A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.,"[{'ForeName': 'Joan-Carles', 'Initials': 'JC', 'LastName': 'Arce', 'Affiliation': 'Ferring Pharmaceuticals, Reproductive Medicine & Maternal Health, Copenhagen, Denmark. Electronic address: jca@ferring.com.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Larsson', 'Affiliation': 'Ferring Pharmaceuticals, Global Biometrics, Copenhagen, Denmark.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'García-Velasco', 'Affiliation': 'IVI-RMA Madrid, Madrid, Spain.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.07.006']
1856,32819881,"Phase 1 Trial Evaluating Vorinostat Plus Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma.","INTRODUCTION
Bortezomib plus lenalidomide and dexamethasone (VRD) is a standard induction therapy for newly diagnosed multiple myeloma (NDMM) patients. Given preclinical and clinical data suggesting the synergistic activity of the histone deacetylase inhibitor vorinostat with both bortezomib and lenalidomide for the treatment of multiple myeloma, we hypothesized that adding vorinostat to VRD (R2V2) would increase the rate and the quality of responses to induction treatment. Here we report the results of a phase 1 trial (NCT01038388) evaluating R2V2 as up-front treatment for NDMM patients.
PATIENTS AND METHODS
R2V2 was tested as induction therapy in a dose-escalation phase 1 study in 30 NDMM patients deemed eligible for autologous stem-cell transplantation. Treatment consisted of 4 induction cycles with R2V2, followed by either autologous stem-cell transplantation or 4 additional R2V2 cycles and lenalidomide maintenance therapy.
RESULTS
The maximum tolerated dose of vorinostat was 200 mg daily. The most common adverse events were gastrointestinal (87%), fatigue and peripheral neuropathy (60%), and thrombocytopenia (33%). R2V2 induced an objective response in 96% of patients, with 48% obtaining at least a complete remission. Median progression-free survival was 52 months, with 77% of patients alive at 5 years.
CONCLUSION
R2V2 as induction treatment for NDMM patients resulted in remarkable response rates at the cost of increased toxicity.",2020,"R2V2 induced an objective response in 96% of patients, with 48% obtaining at least a complete remission.","['NDMM patients', '30 NDMM patients deemed eligible for autologous stem-cell transplantation', 'newly diagnosed multiple myeloma (NDMM) patients', 'Patients With Newly Diagnosed Multiple Myeloma']","['Vorinostat Plus Bortezomib, Lenalidomide, and Dexamethasone', 'Bortezomib plus lenalidomide and dexamethasone (VRD', '4 induction cycles with R2V2, followed by either autologous stem-cell transplantation or 4 additional R2V2 cycles and lenalidomide maintenance therapy']","['Median progression-free survival', 'fatigue and peripheral neuropathy', 'toxicity', 'thrombocytopenia', 'objective response']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0821328,"R2V2 induced an objective response in 96% of patients, with 48% obtaining at least a complete remission.","[{'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mina', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA. Electronic address: roberto.mina.rm@gmail.com.'}, {'ForeName': 'Jatin J', 'Initials': 'JJ', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Laubach', 'Affiliation': 'LeBow Institute for Myeloma Therapeutics and Jerome Lipper Center for Multiple Myeloma Research, Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Charise', 'Initials': 'C', 'LastName': 'Gleason', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sharp', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'R Donald', 'Initials': 'RD', 'LastName': 'Harvey', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Leonard T', 'Initials': 'LT', 'LastName': 'Heffner', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'LeBow Institute for Myeloma Therapeutics and Jerome Lipper Center for Multiple Myeloma Research, Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma/Myeloma, The University of Texas, MD Anderson Cancer Center, Houston, TX.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.07.013']
1857,32816639,Buspirone decreases susceptibility to hypocapnic central sleep apnea in chronic SCI patients.,"Spinal cord injury (SCI) is a risk factor for central sleep apnea (CSA). Previous studies in animal models with SCI have demonstrated a promising recovery in respiratory and phrenic nerve activity post-injury induced by the systemic and local administration of serotonin receptor agonists such as Buspirone and Trazodone. Human trials must be performed to determine whether individuals with SCI respond similarly. We hypothesized that Buspirone and Trazodone would decrease the propensity to hypocapnic CSA during sleep. We studied eight males with chronic SCI and sleep-disordered breathing (SDB) [age: 48.8 ± 14.2 yr; apnea-hypopnea index (AHI): 44.9 ± 23.1] in a single-blind crossover design. For 13 days, participants were randomly assigned either Buspirone (7.5-15 mg twice daily), Trazodone (100 mg), or a placebo followed by a 14-day washout period before crossing over to the other interventions. Study nights included polysomnography and induction of CSA using a noninvasive ventilation protocol. We assessed indexes of SDB, CO 2 reserve, apneic threshold (AT), controller gain (CG), plant gain (PG), and ventilatory parameters. CO 2 reserve was significantly widened on Buspirone (-3.6 ± 0.9 mmHg) compared with both Trazodone (-2.5 ± 1.0 mmHg, P = 0.009) and placebo (-1.8 ± 1.5 mmHg, P < 0.001) but not on Trazodone vs. placebo ( P = 0.061). CG was significantly decreased on Buspirone compared with placebo (1.8 ± 0.4 vs. 4.0 ± 2.0 L/(mmHg·min), P = 0.025) but not on Trazodone compared with placebo (2.5 ± 1.1 vs. 4.0 ± 2.0 L/(mmHg·min); P = 0.065). There were no significant differences for PG, AT, or any SDB indexes (AHI, obstructive apnea index, central apnea index, oxygen desaturation index). The administration of Buspirone decreased the susceptibility to induced hypocapnic central apnea by reducing chemosensitivity and increasing CO 2 reserve in chronic SCI patients. NEW & NOTEWORTHY This research study is novel as it is the first study in a humans that we are aware of that demonstrates the ability of Buspirone to increase CO 2 reserve and hence decrease susceptibility to hypocapnic central apnea in patients with spinal cord injury.",2020,"There were no significant differences for PG, AT or any SDB indices (AHI, OAI, CAI, ODI).","['individuals with SCI respond similarly', '8 males with chronic SCI and sleep-disordered breathing (SDB)(Age', 'Chronic SCI Patients', 'chronic SCI patients']","['Trazodone', 'Buspirone and Trazodone', 'Buspirone', 'Trazodone vs. placebo', 'placebo']","['PG, AT or any SDB indices (AHI, OAI, CAI, ODI', 'CO 2 reserve', 'SDB, CO 2 reserve, apneic threshold (AT), controller gain (CG), plant gain (PG) and ventilatory parameters', 'CG']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",8.0,0.0422913,"There were no significant differences for PG, AT or any SDB indices (AHI, OAI, CAI, ODI).","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Maresh', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Prowting', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vaughan', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kruppe', 'Affiliation': ''}, {'ForeName': 'Bander', 'Initials': 'B', 'LastName': 'Alsabri', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Yarandi', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Abdulghani', 'Initials': 'A', 'LastName': 'Sankari', 'Affiliation': 'Sleep Research Laboratory, John D. Dingell Veterans Affairs Medical Center, Wayne State University, Detroit, Michigan.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00435.2020']
1858,32827221,Transcranial Magnetic Stimulation Promotes Gait Training in Parkinson Disease.,"OBJECTIVE
To determine whether priming with 1 or 25Hz repetitive transcranial magnetic stimulation (rTMS) will enhance the benefits from treadmill training up to 3 months postintervention in people with Parkinson disease (PD), and to evaluate the underlying changes in cortical excitability.
METHODS
This randomized double-blind, placebo-controlled trial was conducted between October 2016 and December 2018. Fifty-one participants with PD were randomized to receive 12 sessions of rTMS (25Hz, 1Hz, or sham) followed by treadmill training. All participants were assessed at baseline and 1 day, 1 month, and 3 months postintervention. Primary outcome was fastest walking speed, and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS.
RESULTS
The 1 and 25Hz rTMS groups produced a greater improvement in fastest walking speed at 1 day and 3 months postintervention than the sham group. Only the 1 and 25Hz rTMS groups sustained the improvements in TUG, and had a significant improvement in DT-TUG and MDS-UPDRS-III for up to 3 months. Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.
INTERPRETATION
Priming with 1 and 25Hz rTMS can augment the benefits of treadmill training and lead to long-term motor improvement up to 3 months postintervention. The motor improvement at follow-up was associated with a normalization of cortical excitability, which in turn suggests an alteration of the homeostatic plasticity range. Rebalancing cortical excitability by rTMS appears critical for plasticity induction. ANN NEUROL 2020;88:933-945.",2020,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"['Oct 2016 and Dec 2018', ""Parkinson's disease"", 'Fifty-one participants with PD', ""people with Parkinson's disease (PD""]","['Transcranial magnetic stimulation promotes gait training', '1 Hz or 25 Hz repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'rTMS (25 Hz, 1 Hz or sham) followed by treadmill training', 'placebo']","['fastest walking speed', 'cortical silent period and short-interval intracortical inhibition', 'DT-TUG and MDS-UPDRS-III', ""fastest walking speed and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS""]","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",51.0,0.305734,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"[{'ForeName': 'Chloe Lau-Ha', 'Initials': 'CL', 'LastName': 'Chung', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Margaret Kit-Yi', 'Initials': 'MK', 'LastName': 'Mak', 'Affiliation': 'Department of Rehabilitation Sciences, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA.'}]",Annals of neurology,['10.1002/ana.25881']
1859,33234638,Theory-based digital intervention to promote weight loss and weight loss maintenance (Choosing Health): protocol for a randomised controlled trial.,"INTRODUCTION
Digital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.
METHODS AND ANALYSIS
The proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.
ETHICS AND DISSEMINATION
Ethics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.
TRIAL REGISTRATION DETAILS
This trial was registered with www.clinicaltrials.gov; registration number NCT04291482.",2020,"Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss.","['Participants (n=285', 'overweight/obese adults']","['Choosing Health digital intervention or a control group', 'Control group participants will receive non-tailored weight loss advice via e-book and generic emails', 'Theory-based digital intervention']","['mean difference in weight loss', 'weight loss and weight loss maintenance', 'blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss', 'daily weight loss plan adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",285.0,0.159675,"Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss.","[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kwasnicka', 'Affiliation': 'Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland dkwasnicka@swps.edu.pl.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Luszczynska', 'Affiliation': 'Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'Psychological Sciences, University of California, Merced, Merced, California, United States.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Quested', 'Affiliation': 'Physical Activity and Well-being Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Sherry L', 'Initials': 'SL', 'LastName': 'Pagoto', 'Affiliation': 'Department of Allied Health Sciences, The UConn Center for mHealth and Social Media, University of Connecticut, Connecticut, New England, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verboon', 'Affiliation': 'Department of Psychology and Educational Sciences, Open Universiteit Nederland Faculteit Managementwetenschappen, Heerlen, Limburg, The Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Januszewicz', 'Affiliation': 'Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Idziak', 'Affiliation': 'Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland.'}, {'ForeName': 'Iga', 'Initials': 'I', 'LastName': 'Palacz', 'Affiliation': 'Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Naughton', 'Affiliation': 'School of Health Sciences, University of East Anglia Faculty of Medicine and Health Sciences, Norwich, Norfolk, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040183']
1860,33234641,Community psychosocial music intervention (CHIME) to reduce antenatal common mental disorder symptoms in The Gambia: a feasibility trial.,"OBJECTIVES
Examine the feasibility of a Community Health Intervention through Musical Engagement (CHIME) in The Gambia to reduce common mental disorder (CMD) symptoms in pregnant women.
DESIGN
Feasibility trial testing a randomised stepped-wedge cluster design.
SETTING
Four local antenatal clinics.
PARTICIPANTS
Women who were 14-24 weeks pregnant and spoke Mandinka or Wolof were recruited into the intervention (n=50) or control group (n=74).
INTERVENTION
Music-based psychosocial support sessions designed and delivered by all-female fertility societies. Sessions lasted 1 hour and were held weekly for 6 weeks. Delivered to groups of women with no preselection. Sessions were designed to lift mood, build social connection and provide health messaging through participatory music making. The control group received standard antenatal care.
OUTCOMES
Demographic, feasibility, acceptability outcomes and the appropriateness of the study design were assessed. Translated measurement tools (Self-Reporting Questionnaire (SRQ-20); Edinburgh Postnatal Depression Scale (EPDS)) were used to assess CMD symptoms at baseline, post-intervention and 4-week follow-up.
RESULTS
All clinics and 82% of women approached consented to take part. A 33% attrition rate across all time points was observed. 72% in the intervention group attended at least three sessions. Audio and video analysis confirmed fidelity of the intervention and a thematic analysis of participant interviews demonstrated acceptability and positive evaluation. Results showed a potential beneficial effect with a reduction of 2.13 points (95% CI (0.89 to 3.38), p<0.01, n=99) on the SRQ-20 and 1.98 points (95% CI (1.06 to 2.90), p<0.01, n=99) on the EPDS at the post-intervention time point for the intervention group compared with standard care.
CONCLUSION
Results demonstrate that CHIME is acceptable and feasible in The Gambia. To our knowledge, CHIME is the first example of a music-based psychosocial intervention to be applied to perinatal mental health in a low- and middle-income country context.
TRIAL REGISTRATION NUMBER
Pan African Clinical Trials Registry (PACTR201901917619299).",2020,"OBJECTIVES
Examine the feasibility of a Community Health Intervention through Musical Engagement (CHIME) in The Gambia to reduce common mental disorder (CMD) symptoms in pregnant women.
","['Women who were 14-24 weeks pregnant and spoke Mandinka or Wolof were recruited into the intervention (n=50) or control group (n=74', 'Four local antenatal clinics', 'pregnant women']","['Music-based psychosocial support sessions designed and delivered by all-female fertility societies', 'CHIME', 'Community psychosocial music intervention (CHIME', 'standard antenatal care', 'Community Health Intervention through Musical Engagement (CHIME']","['CMD symptoms', 'Translated measurement tools (Self-Reporting Questionnaire (SRQ-20); Edinburgh Postnatal Depression Scale (EPDS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0574528', 'cui_str': 'Wolof language'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}]",,0.119969,"OBJECTIVES
Examine the feasibility of a Community Health Intervention through Musical Engagement (CHIME) in The Gambia to reduce common mental disorder (CMD) symptoms in pregnant women.
","[{'ForeName': 'Katie Rose M', 'Initials': 'KRM', 'LastName': 'Sanfilippo', 'Affiliation': 'Psychology Department, Goldsmiths, University of London, London, UK ksanf001@gold.ac.uk.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'McConnell', 'Affiliation': 'School of Music, The Australian National University, Canberra, New South Wales, Australia.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Imperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Buba', 'Initials': 'B', 'LastName': 'Darboe', 'Affiliation': 'The Ministry of Health and Social Welfare, Banjul, The Gambia.'}, {'ForeName': 'Hajara B', 'Initials': 'HB', 'LastName': 'Huma', 'Affiliation': 'The Ministry of Health and Social Welfare, Banjul, The Gambia.'}, {'ForeName': 'Malick', 'Initials': 'M', 'LastName': 'Gaye', 'Affiliation': 'The Ministry of Health and Social Welfare, Banjul, The Gambia.'}, {'ForeName': 'Hassoum', 'Initials': 'H', 'LastName': 'Ceesay', 'Affiliation': 'The National Centre for Arts and Culture, Banjul, The Gambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ramchandani', 'Affiliation': 'Faculty of Education, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cross', 'Affiliation': 'Centre for Music & Science, Faculty of Music, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Vivette', 'Initials': 'V', 'LastName': 'Glover', 'Affiliation': 'Institute of Reproductive and Developmental Biology, Imperial College London, London, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Stewart', 'Affiliation': 'Psychology Department, Goldsmiths, University of London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040287']
1861,31964219,Protective role of black seed oil in doxorubicin-induced cardiac toxicity in children with acute lymphoblastic leukemia.,"BACKGROUND
Leukemia is the most common pediatric malignancy. It affects bone marrow cells especially lymphoid cell precursor. Leukemia is treated mainly by chemotherapy. Doxorubicin is a well-established chemotherapeutic agent included in treatment protocols of acute lymphoblastic leukemia. Its efficacy is often limited by its cardiotoxic side effects. Many studies are directed to overcome this problem. Black seed oil was found to have a potent cardioprotective effect. Aim of the study: To assess the protective role of black seed oil against doxorubicin-induced cardiotoxicity in children with acute lymphoblastic leukemia.
SUBJECTS AND METHODS
This study was carried out on 40 children with acute lymphoblastic leukemia including 20 patients under doxorubicin therapy and black seed oil 80 mg/kg/dose divided into 3 doses starting at the same moment of beginning of doxorubicin infusion therapy and continued for 1 week after each doxorubicin dose [group I] and 20 patients under doxorubicin and placebo for 1 week after each doxorubicin dose [group II]. They underwent conventional echo-Doppler measures of left ventricular systolic and diastolic functions and pulsed wave tissue Doppler of lateral mitral annulus.
RESULTS
No significant differences were found in parameters of electrocardiograph including S-T segment and Q-T interval either before or after doxorubicin therapy. No significant differences in echocardiographic parameters were found between group I and group II before therapy. Non-significant changes in parameters of diastolic function [E/A ratio or e/a ratio] were found after doxorubicin therapy in group I and II, but there were significant reduction in parameters of systolic function [EF, FS and s wave] after doxorubicin therapy more in group II than group I. Conclusion and recommendation: From this study, we concluded that: Black seed oil improves some cardiac side effects of doxorubicin as shown by better systolic functions in children with acute lymphoblastic leukemia who were treated with Doxorubicin and black seed (group I) than in children with acute lymphoblastic leukemia who were treated with doxorubicin alone with no black seeds (group II), and therefore multi center studies is recommended to be done before we can recommend the use of black seed oil as an adjuvant therapy in patients with acute lymphoblastic leukemia under doxorubicin-based treatment protocol.",2020,"Non-significant changes in parameters of diastolic function [E/A ratio or e/a ratio] were found after doxorubicin therapy in group I and II, but there were significant reduction in parameters of systolic function [EF, FS and s wave] after doxorubicin therapy more in group II than group I. Conclusion and recommendation: From this study","['40 children with acute lymphoblastic leukemia including 20 patients under', 'patients with acute lymphoblastic leukemia under', 'group I) than in children with acute lymphoblastic leukemia', '20 patients under', 'children with acute lymphoblastic leukemia', 'acute lymphoblastic leukemia', 'children with acute lymphoblastic leukemia who were treated with']","['black seed oil in doxorubicin', 'doxorubicin dose [group', 'doxorubicin and placebo', 'Black seed oil', 'doxorubicin alone with no black seeds', 'doxorubicin-based treatment protocol', 'Doxorubicin and black seed', 'doxorubicin', 'conventional echo-Doppler measures of left ventricular systolic and diastolic functions and pulsed wave tissue Doppler of lateral mitral annulus', 'doxorubicin infusion therapy', 'black seed oil against doxorubicin-induced cardiotoxicity', 'doxorubicin therapy and black seed oil 80', 'Doxorubicin']","['echocardiographic parameters', 'systolic function [EF, FS and s wave', 'parameters of electrocardiograph including S-T segment and Q-T interval', 'systolic functions', 'cardiac toxicity', 'diastolic function [E/A ratio or e/a ratio']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0225947', 'cui_str': 'Structure of anulus fibrosus of mitral orifice'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0429094', 'cui_str': 'S wave feature'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0876994', 'cui_str': 'Cardiotoxicity'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0122988,"Non-significant changes in parameters of diastolic function [E/A ratio or e/a ratio] were found after doxorubicin therapy in group I and II, but there were significant reduction in parameters of systolic function [EF, FS and s wave] after doxorubicin therapy more in group II than group I. Conclusion and recommendation: From this study","[{'ForeName': 'Adel A', 'Initials': 'AA', 'LastName': 'Hagag', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ibrahim M', 'Initials': 'IM', 'LastName': 'Badraia', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Walid A', 'Initials': 'WA', 'LastName': 'El-Shehaby', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Maaly M', 'Initials': 'MM', 'LastName': 'Mabrouk', 'Affiliation': 'Pediatric Department, Tanta University, Tanta, Egypt.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155219897294']
1862,32830462,Effect of vitamin D supplementation on N-glycan branching and cellular immunophenotypes in MS.,"OBJECTIVE
To investigate the effect of cholecalciferol (vitamin D3) supplementation on peripheral immune cell frequency and N-glycan branching in patients with relapsing-remitting multiple sclerosis (RRMS).
METHODS
Exploratory analysis of high-dose (20 400 IU) and low-dose (400 IU) vitamin D3 supplementation taken every other day of an 18-month randomized controlled clinical trial including 38 RRMS patients on stable immunomodulatory therapy (NCT01440062). We investigated cholecalciferol treatment effects on N-glycan branching using L-PHA stain (phaseolus vulgaris leukoagglutinin) at 6 months and frequencies of T-, B-, and NK-cell subpopulations at 12 months with flow cytometry.
RESULTS
High-dose supplementation did not change CD3+ T cell subsets, CD19+ B cells subsets, and NK cells frequencies, except for CD8+ T regulatory cells, which were reduced in the low-dose arm compared to the high-dose arm at 12 months. High-dose supplementation decreased N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI). A reduction of N-glycan branching in B cells was not significant. In contrast, low-dose supplementation did not affect N-glycan branching. Changes in N-glycan branching did not correlate with cell frequencies.
INTERPRETATION
Immunomodulatory effect of vitamin D may involve regulation of N-glycan branching in vivo. Vitamin D3 supplementation did at large not affect the frequencies of peripheral immune cells.",2020,"High-dose supplementation decreased N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI).","['38 RRMS patients on stable immunomodulatory therapy (NCT01440062', 'patients with relapsing-remitting multiple sclerosis (RRMS']","['vitamin D supplementation', 'vitamin D', 'cholecalciferol (vitamin D3) supplementation', 'cholecalciferol', 'low-dose (400\xa0IU) vitamin D3 supplementation', 'Vitamin D3 supplementation']","['frequencies of peripheral immune cells', 'peripheral immune cell frequency and N-glycan branching', 'N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI', 'change CD3+\xa0T cell subsets, CD19+ B cells subsets, and NK cells frequencies, except for CD8+\xa0T regulatory cells']","[{'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1963758', 'cui_str': 'Immunomodulatory therapy'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030779', 'cui_str': 'Pelger-Huët anomaly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0079004', 'cui_str': 'B-Cell Subsets'}, {'cui': 'C0332300', 'cui_str': 'Except for'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}]",38.0,0.136472,"High-dose supplementation decreased N-glycan branching on T and NK cells, measured as L-PHA mean fluorescence intensity (MFI).","[{'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Bäcker-Koduah', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Infante-Duarte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Institute for Medical Immunology, Berlin, Germany.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ivaldi', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, CEBR University of Genoa, Genoa, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Uccelli', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, CEBR University of Genoa, Genoa, Italy.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bellmann-Strobl', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Klaus-Dieter', 'Initials': 'KD', 'LastName': 'Wernecke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sy', 'Affiliation': 'Department of Neurology, University of California, Irvine, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Demetriou', 'Affiliation': 'Department of Neurology, University of California, Irvine, CA, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dörr', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Ulrich Brandt', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin, Humboldt - Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51148']
1863,32840201,"Impact of Low-Cost Point-of-Use Water Treatment Technologies on Enteric Infections and Growth among Children in Limpopo, South Africa.","Enteric infections early in life have been associated with poor linear growth among children in low-resource settings. Point-of-use water treatment technologies provide effective and low-cost solutions to reduce exposure to enteropathogens from drinking water, but it is unknown whether the use of these technologies translates to improvements in child growth. We conducted a community-based randomized controlled trial of two water treatment technologies to estimate their effects on child growth in Limpopo, South Africa. We randomized 404 households with a child younger than 3 years to receive a silver-impregnated ceramic water filter, a silver-impregnated ceramic tablet, a safe-storage water container alone, or no intervention, and these households were followed up quarterly for 2 years. We estimated the effects of the interventions on linear and ponderal growth, enteric infections assessed by quantitative molecular diagnostics, and diarrhea prevalence. The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples. However, the filters and tablets were not associated with differences in height (height-for-age z -score differences compared with no intervention: 0.06, 95% CI: -0.29, 0.40, and 0.00, 95% CI: -0.35, 0.35, respectively). There were also no effects of the interventions on weight, diarrhea prevalence, or enteric infections. Despite their effectiveness in treating drinking water, the use of the silver-impregnated ceramic water filters and tablets did not reduce enteric infections or improve child growth. More transformative water, sanitation, and hygiene interventions that better prevent enteric infections are likely needed to improve long-term child growth outcomes.",2020,"The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples.","['Children in Limpopo, South Africa', '404 households with a child younger than 3 years to receive a', 'child growth in Limpopo, South Africa']","['silver-impregnated ceramic water filter, a silver-impregnated ceramic tablet, a safe-storage water container alone, or no intervention', 'Low-Cost Point-of-Use Water Treatment Technologies']","['enteric infections', 'weight, diarrhea prevalence, or enteric infections', 'linear and ponderal growth, enteric infections assessed by quantitative molecular diagnostics, and diarrhea prevalence', 'total coliform bacteria']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]","[{'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0180098', 'cui_str': 'Container'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0597684', 'cui_str': 'Water Treatment'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C2121080', 'cui_str': 'Molecular Diagnostics'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0314760', 'cui_str': 'Coliform bacteria'}]",404.0,0.0517983,"The silver-impregnated ceramic water filters and tablets consistently achieved approximately 1.2 and 3 log reductions, respectively, in total coliform bacteria in drinking water samples.","[{'ForeName': 'Courtney L', 'Initials': 'CL', 'LastName': 'Hill', 'Affiliation': 'Department of Engineering Systems and Environment, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'McCain', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Mzwakhe E', 'Initials': 'ME', 'LastName': 'Nyathi', 'Affiliation': 'Department of Animal Science, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Edokpayi', 'Affiliation': 'Department of Hydrology and Water Resources Mining and Environmental Geology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kahler', 'Affiliation': 'Center for Environmental Research and Education, Duquesne University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Darwin J', 'Initials': 'DJ', 'LastName': 'Operario', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'David D J', 'Initials': 'DDJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Civil and Mineral Engineering, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Wright', 'Affiliation': 'Department of Mechanical Engineering, University of Minnesota Twin Cities, Minneapolis, Minnesota.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Engineering Systems and Environment, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Amidou', 'Initials': 'A', 'LastName': 'Samie', 'Affiliation': 'Department of Microbiology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Dillingham', 'Affiliation': 'Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Pascal O', 'Initials': 'PO', 'LastName': 'Bessong', 'Affiliation': 'Department of Microbiology, University of Venda, Thohoyandou, South Africa.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Rogawski McQuade', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0228']
1864,32840230,"Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells in Chronic Ischemic Cardiomyopathy: A Controlled, Randomized Clinical Trial (HUC-HEART Trial).","Background and Objectives
The HUC-HEART Trial (ClinicalTrials.gov Identifier: NCT02323477) was a controlled, prospective, phase I/II, multicenter, single-blind, three-arm randomized study of intramyocardial delivery of human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG) in patients with chronic ischemic cardiomyopathy (CIC). The trial aimed to assess (i) the safety and the efficacy of cell transplantation during one-year follow-up, (ii) to compare the efficacy of HUC-MSCs with autologous bone-marrow- derived mononuclear cells (BM-MNCs) in the same clinical settings.
Methods and Results
Fifty-four patients who were randomized to receive HUC-MSCs (23×10 6 ) (n=26) or BM-MNCs (70×10 7 ) (n=12) in combination with CABG surgery. The control patients (n=16) received no cells/vehicles but CABG intervention. All patients were screened at baseline and 1, 3, 6, 12 months after transplantation. Forty-six (85%) patients completed 12 months follow-up. No short/mid-term adverse events were encountered. Decline in NT-proBNP (baseline∼ 6 months) in both cell-treated groups; an increase in left ventricular ejection fraction (LVEF) (5.4%) and stroke volume (19.7%) were noted (baseline∼6 or 12 months) only in the HUC-MSC group. Decreases were also detected in necrotic myocardium as 2.3% in the control, 4.5% in BM-MNC, and 7.7% in the HUC-MSC groups. The 6-min walking test revealed an increase in the control (14.4%) and HUC-MSC (23.1%) groups.
Conclusions
Significant findings directly related to the intramyocardial delivery of HUC-MSCs justified their efficacy in CIC. Stricter patient selection criteria with precisely aligned cell dose and delivery intervals, rigorous follow-up by detailed diagnostic approaches would further help to clarify the responsiveness to the therapy.",2020,"The 6-min walking test revealed an increase in the control (14.4%) and HUC-MSC (23.1%) groups.
","['23×10 6 ) (n=26) or BM-MNCs (70×10 7 ', 'Chronic Ischemic Cardiomyopathy', 'patients with chronic ischemic cardiomyopathy (CIC']","['HUC-MSCs with autologous bone-marrow- derived mononuclear cells (BM-MNCs', 'no cells/vehicles but CABG intervention', 'Intramyocardial Transplantation of Umbilical Cord Mesenchymal Stromal Cells', 'intramyocardial delivery of human umbilical cord-derived mesenchymal stromal cells (HUC-MSCs) combined with coronary artery bypass-grafting (CABG', 'CABG surgery', 'HUC-MSCs']","['left ventricular ejection fraction (LVEF', 'HUC-MSC', 'Decline in NT-proBNP', 'necrotic myocardium', '6-min walking test', 'stroke volume']","[{'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1294062', 'cui_str': 'Mononuclear cell count'}, {'cui': 'C0574187', 'cui_str': 'Manchu language'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0027061', 'cui_str': 'Cardiac muscle (tissue)'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}]",54.0,0.0887874,"The 6-min walking test revealed an increase in the control (14.4%) and HUC-MSC (23.1%) groups.
","[{'ForeName': 'A Tulga', 'Initials': 'AT', 'LastName': 'Ulus', 'Affiliation': 'Department of Cardiovascular Surgery, Hacettepe University Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Mungan', 'Affiliation': 'Ankara University Biotechnology Institute and Sisbiyotek, Ankara, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kurtoglu', 'Affiliation': 'Cardiovascular Surgery Division, Ankara Guven Hospital, Ankara, Turkey.'}, {'ForeName': 'Ferda Topal', 'Initials': 'FT', 'LastName': 'Celikkan', 'Affiliation': 'Department of Histology and Embryology, Laboratory for Stem Cells and Reproductive Cell Biology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Akyol', 'Affiliation': 'Department of Biostatistics, Ankara Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Sucu', 'Affiliation': 'Ankara University Biotechnology Institute and Sisbiyotek, Ankara, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Toru', 'Affiliation': 'Radiology Division, Ankara Liv Hospital, Ankara, Turkey.'}, {'ForeName': 'Serdar Savas', 'Initials': 'SS', 'LastName': 'Gul', 'Affiliation': 'Visart Medical Imaging Center, Ankara, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Cinar', 'Affiliation': 'Department of Histology and Embryology, Laboratory for Stem Cells and Reproductive Cell Biology, Ankara University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Alp', 'Initials': 'A', 'LastName': 'Can', 'Affiliation': 'Department of Histology and Embryology, Laboratory for Stem Cells and Reproductive Cell Biology, Ankara University School of Medicine, Ankara, Turkey.'}]",International journal of stem cells,['10.15283/ijsc20075']
1865,32873473,Which Nursing Home Residents With Pneumonia Are Managed On-Site and Which Are Hospitalized? Results from 2 Years' Surveillance in 14 US Homes.,"OBJECTIVES
Pneumonia is a frequent cause of hospitalization among nursing home (NH) residents, but little information is available as to how clinical presentation and other characteristics relate to hospitalization, and the differential use of antimicrobials based on hospitalization status. This study examined how hospitalized and nonhospitalized NH residents with pneumonia differ.
DESIGN
Data from a 2-year prospective study of residents who participated in a randomized controlled trial.
SETTING AND PARTICIPANTS
All residents from 14 NHs in North Carolina followed for pneumonia over a 2-year period.
METHODS
Clinical features, antimicrobial treatment, hospitalization, and demographic data on residents with a pneumonia diagnosis were abstracted from charts; NH information was obtained from NH administrators.
RESULTS
A total of 509 pneumonia episodes were reported for 395 unique residents; the incidence was not higher in the winter months, and 28% were hospitalized. The likelihood of hospitalization did not differ by clinical characteristics except that residents with a respiratory rate >25 breaths per minute were more likely to be hospitalized. Being on hospice [odds ratio (OR) 3.3, 95% confidence interval (CI) 1.5-7.4] and not having dementia (OR 1.9, 95% CI 1.1-3.2) also related to increased likelihood of hospitalization. Fluoroquinolone (usually levofloxacin) monotherapy was the most common treatment (54%) in both settings, and ceftriaxone monotherapy varied by hospitalization status (7% of hospitalized vs 16% treated on-site). Approximately 36% of nonhospitalized residents received antimicrobials for more than 7 days.
CONCLUSIONS/IMPLICATIONS
Respiratory rate is associated with hospitalization but was not documented for more than a quarter of residents, suggesting the clinical benefit of more consistently conducting this assessment. Differential hospitalization rates for persons with dementia and on hospice suggest that care is being tailored to individuals' wishes, but this assumption merits study, as does use of fluoroquinolones (due to side effects) and treatment duration (due to potential contribution to antibiotic resistance).",2020,The likelihood of hospitalization did not differ by clinical characteristics except that residents with a respiratory rate >25 breaths per minute were more likely to be hospitalized.,"['residents with a pneumonia diagnosis were abstracted from charts; NH information was obtained from NH administrators', 'All residents from 14 NHs in North Carolina followed for pneumonia over a 2-year period', 'residents who participated in a randomized controlled trial', 'hospitalized and nonhospitalized NH residents with pneumonia differ', 'persons with dementia']","['ceftriaxone monotherapy', 'Fluoroquinolone (usually levofloxacin) monotherapy', 'fluoroquinolones']","['Differential hospitalization rates', 'hospitalization status', 'likelihood of hospitalization']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]","[{'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0897331,The likelihood of hospitalization did not differ by clinical characteristics except that residents with a respiratory rate >25 breaths per minute were more likely to be hospitalized.,"[{'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Tandan', 'Affiliation': 'The Cecil G. Sheps Center for Health Service Research, University of North Carolina, Chapel Hill, NC, USA. Electronic address: meerat@email.unc.edu.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'The Cecil G. Sheps Center for Health Service Research, University of North Carolina, Chapel Hill, NC, USA; Schools of Social Work and Public Health, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Service Research, University of North Carolina, Chapel Hill, NC, USA; Department of Family Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The Cecil G. Sheps Center for Health Service Research, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Daniels', 'Affiliation': 'Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Service Research, University of North Carolina, Chapel Hill, NC, USA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.07.028']
1866,32876010,"Primary Prophylaxis to Prevent Tuberculosis Infection in Prison Inmates: A Randomized, Double-Blind, Placebo-Controlled Trial.","In many low- and middle-income countries, tuberculosis (TB) incidence in prisons is high, exposing incarcerated populations to an elevated risk of TB infection. We conducted a randomized, double-blind, placebo-controlled trial among HIV-negative male inmates of a high TB burden prison to determine whether isoniazid given twice weekly (900 mg) for 12 months prevents TB infection. The primary outcome was QuantiFERON-TB Gold in Plus (QFT) conversion to ≥ 0.35 international units per milliliter (IU/mL) at 6 months; secondary outcomes included alternative QFT thresholds (≥ 0.7, ≥ 2.0, and ≥ 4.0 IU/mL). In total, 467 participants were randomly assigned to intervention ( N = 258) or control ( N = 209). In an interim analysis of participants who had completed 6 months of follow-up ( N = 170), QFT conversion occurred in 20.8% (19/91) and 21.5% (17/79) of participants in intervention and control arms (efficacy: 2.9%, P = 0.91), respectively. The trial was then stopped according to the trial protocol, and the remaining participants prematurely discontinued. In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%, P < 0.01). In conclusion, 900 mg of isoniazid, administered twice a week, did not effectively prevent QFT conversion at a cutoff point ≥ 0.35 IU/mL in a trial of QFT-negative inmates. Higher QFT cutoffs are associated with sustained conversion and greater protection. Future clinical trials that evaluate protection for latent infection should use the highest cutoff than that recommended by the manufacturer.",2020,"In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%, P < 0.01).","['Prison Inmates', '467 participants were randomly assigned to intervention ( N = 258) or control ( N = 209', 'HIV-negative male inmates of a high TB burden prison']","['placebo', 'Placebo', 'isoniazid']","['QFT conversion', 'QuantiFERON-TB Gold in Plus (QFT) conversion to ≥ 0.35 international units per milliliter (IU/mL', 'alternative QFT thresholds', 'TB infection', 'rates of conversion']","[{'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C4517784', 'cui_str': '467'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4517451', 'cui_str': '0.35'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",467.0,0.713576,"In an analysis of secondary outcomes, the intervention arm had significantly lower rates of conversion at a cutoff of ≥ 2.0 IU/mL (efficacy: 82.6%, P < 0.01).","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Dias de Oliveira', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'da Silva Santos', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Cassia Barbosa', 'Initials': 'CB', 'LastName': 'Reis', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'de Cássia Leite', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}, {'ForeName': 'Flávia Patussi', 'Initials': 'FP', 'LastName': 'Correia Sacchi', 'Affiliation': 'Municipal Health Office, Dourados, Brazil.'}, {'ForeName': 'Rafaele Carla Pivetta', 'Initials': 'RCP', 'LastName': 'de Araujo', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Paulo César Pereira', 'Initials': 'PCP', 'LastName': 'Dos Santos', 'Affiliation': 'Federal University of Grande Dourados, Dourados, Brazil.'}, {'ForeName': 'Valeria Cavalcanti', 'Initials': 'VC', 'LastName': 'Rolla', 'Affiliation': 'Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Martinez', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Croda', 'Affiliation': 'Federal University of Mato Grosso do Sul, Campo Grande, Brazil.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0110']
1867,32877884,Reduced morbidity by using LigaSure compared to conventional inguinofemoral lymphadenectomy in vulvar cancer patients: A randomized controlled trial.,"BACKGROUND
Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.
METHODS
In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of ≥1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.
RESULTS
We included 40 groins of 20 patients. The estimated incidence of ≥1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p < 0.001). Patients' reported restriction of daily living activities and maximum pain score were equal for both treatment methods. There were no differences in the surgeon reported workload scores.
CONCLUSIONS
This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.",2020,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"['40 groins of 20 patients', 'vulvar cancer patients', 'women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included']","['conventional IFL (sharp/diathermia', 'Inguinofemoral lymphadenectomy (IFL', 'IFL', 'conventional inguinofemoral lymphadenectomy', 'LigaSure']","['restriction of daily living activities and maximum pain score', 'morbidity', 'estimated incidence of ≥1 complication(s']","[{'cui': 'C0018246', 'cui_str': 'Inguinal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0375071', 'cui_str': 'Malignant tumor of vulva'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0280856', 'cui_str': 'Squamous cell carcinoma of vulva'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy'}, {'cui': 'C1444775', 'cui_str': 'Sharp sensation quality'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.247773,This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL.,"[{'ForeName': 'Anne-Floor W', 'Initials': 'AW', 'LastName': 'Pouwer', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands. Electronic address: Anne-Floor.W.Pouwer@radboudumc.nl.'}, {'ForeName': 'Henriette J', 'Initials': 'HJ', 'LastName': 'Arts', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, Department of Obstetrics and Gynaecology, the Netherlands.'}, {'ForeName': 'Corine M', 'Initials': 'CM', 'LastName': 'Koopmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Department for Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Johanna M A', 'Initials': 'JMA', 'LastName': 'Pijnenborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'de Hullu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Radboud Institute for Health Sciences, Radboud university Medical Center, Nijmegen, the Netherlands.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.011']
1868,32819962,Steroids in COVID-19: An overview.,"Most antiviral or immunomodulatory therapies investigated for use in patients with COVID-19 have failed to show any mortality benefit. Similar to the previous pandemics caused by respiratory viruses, the role and benefit of corticosteroids has been under debate in COVID-19-related pulmonary disease. In this consult, we discuss the evidence regarding the efficacy of corticosteroid use in hospitalized patients with COVID-19, including data from the first randomized controlled trial on this subject.",2020,Most antiviral or immunomodulatory therapies investigated for use in patients with COVID-19 have failed to show any mortality benefit.,"['hospitalized patients with COVID-19', 'Steroids in COVID-19']",['corticosteroid'],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.0965311,Most antiviral or immunomodulatory therapies investigated for use in patients with COVID-19 have failed to show any mortality benefit.,"[{'ForeName': 'Kshitij', 'Initials': 'K', 'LastName': 'Chatterjee', 'Affiliation': 'Fellow, Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic chattek@ccf.org.'}, {'ForeName': 'Chao-Ping', 'Initials': 'CP', 'LastName': 'Wu', 'Affiliation': 'Fellow, Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Fellow, Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Siuba', 'Affiliation': 'Department of Critical Care Medicine, Respiratory Institute, Cleveland Clinic.'}]",Cleveland Clinic journal of medicine,['10.3949/ccjm.87a.ccc059']
1869,32820320,Effect of alirocumab on major adverse cardiovascular events according to renal function in patients with a recent acute coronary syndrome: prespecified analysis from the ODYSSEY OUTCOMES randomized clinical trial.,"AIMS
Statins reduce cardiovascular risk in patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function. It is not known whether proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors provide similar benefit across a range of renal function. We determined whether effects of the PCSK9 inhibitor alirocumab to reduce cardiovascular events and death after ACS are influenced by renal function.
METHODS AND RESULTS
ODYSSEY OUTCOMES compared alirocumab with placebo in patients with recent ACS and dyslipidaemia despite intensive statin treatment. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 was exclusionary. In 18 918 patients, baseline eGFR was 82.8 ± 17.6 mL/min/1.73 m2, and low-density lipoprotein cholesterol (LDL-C) was 92 ± 31 mg/dL. At 36 months, alirocumab decreased LDL-C by 48.5% vs. placebo but did not affect eGFR (P = 0.65). Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization) with fewer deaths. There was no interaction between continuous eGFR and treatment on the primary outcome or death (P = 0.14 and 0.59, respectively). Alirocumab reduced primary outcomes in patients with eGFR ≥90 mL/min/1.73 m2 (n = 7470; hazard ratio 0.784, 95% confidence interval 0.670-0.919; P = 0.003) and 60 to <90 (n = 9326; 0.833, 0.731-0.949; P = 0.006), but not in those with eGFR < 60 (n = 2122; 0.974, 0.805-1.178; P = 0.784). Adverse events other than local injection-site reactions were similar in both groups across all categories of eGFR.
CONCLUSIONS
In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m2.",2020,"In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m2.","['patients with recent ACS and dyslipidaemia despite intensive statin treatment', 'In 18 918 patients, baseline eGFR was 82.8\u2009±\u200917.6\u2009mL', 'patients with eGFR ≥90', 'patients with a recent acute coronary syndrome', 'patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function']","['alirocumab', 'Alirocumab', 'alirocumab with placebo', 'PCSK9 inhibitor alirocumab', 'placebo']","['cardiovascular risk', 'death', 'cardiovascular events and deaths', 'Estimated glomerular filtration rate (eGFR', 'LDL-C', 'low-density lipoprotein cholesterol (LDL-C', 'Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization) with fewer deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertase'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205388', 'cui_str': 'Few'}]",18918.0,0.519613,"In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m2.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Tuñón', 'Affiliation': 'Division of Cardiology, Fundación Jiménez Díaz, Autónoma University, and CIBER CV, Avenida Reyes Católicos 2, 28040 Madrid, Spain.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Department of Cardiology, Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Díaz', 'Affiliation': 'Cardiology Department, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina; Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'R & D clinical Development, Sanofi, Paris, France.'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Clinical Sciences-Cardiovascular & Metabolism Therapeutics, Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'Institute of Cardiology, Kyiv, Ukraine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Clinical Sciences-Cardiovascular & Metabolism Therapeutics, Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Piyamitr', 'Initials': 'P', 'LastName': 'Sritara', 'Affiliation': 'Department of Medicine, Ramathibodi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, NY, USA.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa498']
1870,32826836,Impact of Infant Positioning on Cardiopulmonary Resuscitation Performance During Simulated Pediatric Cardiac Arrest: A Randomized Crossover Study.,"OBJECTIVES
The primary objective was to determine the impact of infant positioning on cardiopulmonary resuscitation performance during simulated pediatric cardiac arrest.
DESIGN
A single-center, prospective, randomized, unblinded manikin study.
SETTING
Medical university-affiliated simulation facility.
SUBJECTS
Fifty-two first-line professional rescuers (n = 52).
INTERVENTIONS
Performance of cardiopulmonary resuscitation was determined using an infant manikin model in three different positions (on a table [T], on the provider's forearm with the manikin's head close to the provider's elbow [P], and on the provider's forearm with the manikin's head close to the provider's palm [D]). For the measurement of important cardiopulmonary resuscitation performance variables, a commercially available infant simulator was modified. In a randomized sequence, healthcare professionals performed single-rescuer cardiopulmonary resuscitation for 3 minutes in each position. Performances of chest compression (primary outcome), ventilation, and hands-off time were analyzed using a multilevel regression model.
MEASUREMENTS AND MAIN RESULTS
Mean (± SD) compression depth significantly differed between table and the other two manikin positions (31 ± 2 [T], 29 ± 3 [P], and 29 ± 3 mm [D]; overall p < 0.001; repeated measures design adjusted difference: T vs P, -2 mm [95% CI, -2 to -1 mm]; T vs D, -1 mm [95% CI, -2 to -1 mm]). Secondary outcome variables showed no significant differences.
CONCLUSIONS
Compressions were significantly deeper in the table group compared to positions on the forearm during cardiopulmonary resuscitation, yet the differences were small and perhaps not clinically important.",2020,"Secondary outcome variables showed no significant differences.
","['Medical university-affiliated simulation facility', 'Fifty-two first-line professional rescuers (n = 52']",[],"['Cardiopulmonary Resuscitation Performance', 'Mean (± SD) compression depth', 'Performances of chest compression (primary outcome), ventilation, and hands-off time', 'cardiopulmonary resuscitation performance']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",[],"[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.058054,"Secondary outcome variables showed no significant differences.
","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mühlbacher', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Pröbstl', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Granegger', 'Affiliation': 'Pediatric Heart Center, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Schiefer', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Duma', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hüpfl', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Herkner', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Röhrich', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schebesta', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002521']
1871,33234645,Azathioprine immunosuppression and disease modification in Parkinson's disease (AZA-PD): a randomised double-blind placebo-controlled phase II trial protocol.,"INTRODUCTION
The immune system is implicated in the aetiology and progression of Parkinson's disease (PD). Inflammation and immune activation occur both in the brain and in the periphery, and a proinflammatory cytokine profile is associated with more rapid clinical progression. Furthermore, the risk of developing PD is related to genetic variation in immune-related genes and reduced by the use of immunosuppressant medication. We are therefore conducting a 'proof of concept' trial of azathioprine, an immunosuppressant medication, to investigate whether suppressing the peripheral immune system has a disease-modifying effect in PD.
METHODS AND ANALYSIS
AZA-PD is a phase II randomised placebo-controlled double-blind trial in early PD. Sixty participants, with clinical markers indicating an elevated risk of disease progression and no inflammatory or immune comorbidity, will be treated (azathioprine:placebo, 1:1) for 12 months, with a further 6-month follow-up. The primary outcome is the change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale gait/axial score in the OFF state over the 12-month treatment period. Exploratory outcomes include additional measures of motor and cognitive function, non-motor symptoms and quality of life. In addition, peripheral and central immune markers will be investigated through analysis of blood, cerebrospinal fluid and PK-11195 positron emission tomography imaging.
ETHICS AND DISSEMINATION
The study was approved by the London-Westminster research ethics committee (reference 19/LO/1705) and has been accepted by the Medicines and Healthcare products Regulatory Agency (MHRA) for a clinical trials authorisation (reference CTA 12854/0248/001-0001). In addition, approval has been granted from the Administration of Radioactive Substances Advisory Committee. The results of this trial will be disseminated through publication in scientific journals and presentation at national and international conferences, and a lay summary will be available on our website.
TRIAL REGISTRATION NUMBERS
ISRCTN14616801 and EudraCT- 2018-003089-14.",2020,The primary outcome is the change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale gait/axial score in the OFF state over the 12-month treatment period.,"['Sixty participants, with clinical markers indicating an elevated risk of disease progression and no inflammatory or immune comorbidity, will be treated ', ""Parkinson's disease (AZA-PD""]","['placebo', 'azathioprine', 'Azathioprine immunosuppression', 'azathioprine:placebo']","['additional measures of motor and cognitive function, non-motor symptoms and quality of life', ""change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale gait/axial score in the OFF state""]","[{'cui': 'C0008963', 'cui_str': 'Clinical Marker'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.552135,The primary outcome is the change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale gait/axial score in the OFF state over the 12-month treatment period.,"[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Greenland', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, Cambridgeshire, UK jcg69@cam.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Cutting', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Sonakshi', 'Initials': 'S', 'LastName': 'Kadyan', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': 'Department of Pharmacy, Cambridge University Hospitals NHS Foundation Trust, Cambridge, Cambridgeshire, UK.'}, {'ForeName': 'Caroline H', 'Initials': 'CH', 'LastName': 'Williams-Gray', 'Affiliation': 'Department of Clinical Neurosciences, University of Cambridge, Cambridge, Cambridgeshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040527']
1872,33234646,"MyCare study: protocol for a controlled trial evaluating the effect of a community-based intervention on psychosocial, clinical outcomes and hospital admission rates for adults with severe mental illness.","INTRODUCTION
People with serious mental illness (SMI) often fail to receive adequate treatment. To provide a higher level of support, mental health systems have been reformed substantially to integrate mental healthcare into the community. MyCare is one such community-based mental health model of care. This paper describes the study protocol of a controlled trial examining the effect of MyCare on psychosocial and clinical outcomes and hospital admission and duration rates for adults with SMI.
METHODS AND ANALYSIS
This is a multisite non-randomised controlled trial with a 3, 6 and 12-month follow-up period. The study participants will be adults (18-64 years of age) with SMI recruited from Hobart, Launceston and the North-West of Tasmania. The treatment group will include adults who receive both the MyCare intervention and standard mental health support; the control group will include adults who receive only standard mental health support. The primary outcome includes psychosocial and clinical functioning and the secondary outcome will examine hospital admission rates and duration of stay. Mixed-effects models will be used to examine outcome improvements between intake and follow-up. This trial will generate the evidence needed to evaluate the effect of a community mental health support programme delivered in Tasmania, Australia. If MyCare results in sustained positive outcomes for adults with SMI, it could potentially be scaled up more broadly across Australia, addressing the inequity and lack of comprehensive treatment that many individuals with SMI experience.
ETHICS AND DISSEMINATION
This study has been approved by the Tasmanian Health and Medical Human Research Ethics Committee. The findings will be disseminated to participants and staff who delivered the intervention, submitted for publication in a peer-reviewed journal and shared at academic conferences.
TRIAL REGISTRATION NUMBER
ACTRN12620000673943.",2020,"To provide a higher level of support, mental health systems have been reformed substantially to integrate mental healthcare into the community.","['adults with SMI', 'participants will be adults (18-64 years of age) with SMI recruited from Hobart, Launceston and the North-West of Tasmania', 'adults with severe mental illness', 'People with serious mental illness (SMI']","['MyCare intervention and standard mental health support; the control group will include adults who receive only standard mental health support', 'community-based intervention', 'MyCare']","['psychosocial and clinical outcomes and hospital admission and duration rates', 'psychosocial and clinical functioning and the secondary outcome will examine hospital admission rates and duration of stay', 'psychosocial, clinical outcomes and hospital admission rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]",,0.160957,"To provide a higher level of support, mental health systems have been reformed substantially to integrate mental healthcare into the community.","[{'ForeName': 'Renée', 'Initials': 'R', 'LastName': ""O'Donnell"", 'Affiliation': 'Monash Centre for Health Research and Implementation, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Savaglio', 'Affiliation': 'Monash Centre for Health Research and Implementation, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Fast', 'Affiliation': 'Baptcare, Tasmania, Victoria, Australia.'}, {'ForeName': 'Ash', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Baptcare, Tasmania, Victoria, Australia.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Vicary', 'Affiliation': 'Baptcare, Footscray, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Skouteris', 'Affiliation': 'Monash Centre for Health Research and Implementation, Monash University, Clayton, Victoria, Australia helen.skouteris@monash.edu.'}]",BMJ open,['10.1136/bmjopen-2020-040610']
1873,33234648,Dexmedetomidine for the prevention of postoperative delirium in patients after intracranial operation for brain tumours (DEPOD study): a study protocol and statistical plan for a multicentre randomised controlled trial.,"INTRODUCTION
Postoperative delirium (POD) is prevalent in patients after major surgery and is associated with adverse outcomes. Several studies have reported that dexmedetomidine, a highly selective α2-adrenergic receptor agonist, can decrease the incidence of POD. However, neurosurgical patients are usually excluded from previous studies. The present study was designed to investigate the impact of prophylactic use of low-dose dexmedetomidine on the incidence of POD in patients after intracranial operation.
METHODS AND ANALYSIS
This is a multicentre, randomised, double-blinded and placebo-controlled trial. Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio. For patients in the dexmedetomidine group, a continuous infusion of dexmedetomidine will be started at a rate of 0.1 μg/kg/hour immediately after enrolment on the day of operation and continued until 08:00 on postoperative day 1. For patients in the placebo group, normal saline will be administered at the same rate as in the dexmedetomidine group. The patients will be followed up for 28 days after enrolment. The primary endpoint is the incidence of POD, which is assessed two times per day using the Confusion Assessment Method for the intensive care unit (ICU), during the first 5 postoperative days. The secondary endpoints include the incidence of dexmedetomidine-related adverse events and non-delirium complications, the length of stay in the ICU and hospital and all-cause 28-day mortality after the operation.
ETHICS AND DISSEMINATION
The study protocol was approved by the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (No KY2019-091-02) and registered at ClinicalTrials.gov. The results of the trial will be presented at national and international conferences relevant to subject fields and submitted to international peer-reviewed journals.
TRIAL REGISTRATION NUMBER
Trial registration number: NCT04399343; Pre-results.",2020,Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio.,"['patients after intracranial operation for brain tumours (DEPOD study', 'patients after intracranial operation', 'Beijing Tiantan Hospital Affiliated to Capital Medical University', 'Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia']","['dexmedetomidine', 'Dexmedetomidine', 'placebo']","['incidence of dexmedetomidine-related adverse events and non-delirium complications, the length of stay in the ICU and hospital and all-cause 28-day mortality', 'incidence of POD', 'incidence of POD, which is assessed two times per day using the Confusion Assessment Method for the intensive care unit (ICU']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",700.0,0.442633,Seven hundred intensive care unit admitted patients after elective intracranial operation for brain tumours under general anaesthesia are randomly assigned to the dexmedetomidine group or the placebo group with a 1:1 ratio.,"[{'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Kun-Ming', 'Initials': 'KM', 'LastName': 'Cheng', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Qu', 'Affiliation': 'Department of Neurosurgical Critical Care, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Critical Care Medicine, Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital, Beijing, China.'}, {'ForeName': 'Penglin', 'Initials': 'P', 'LastName': 'Ma', 'Affiliation': 'Department of Critical Care Medicine, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jian-Xin', 'Initials': 'JX', 'LastName': 'Zhou', 'Affiliation': 'Department of Critical Care Medicine, Beijing Tiantan Hospital, Capital Medical University, Beijing, China zhoujx.cn@icloud.com.'}]",BMJ open,['10.1136/bmjopen-2020-040939']
1874,32830617,"The Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke.","In motor skill learning, larger doses of practice lead to greater efficacy of practice, lower efficiency of practice, and better long-term retention. Whether such learning principles apply to motor practice after stroke is unclear. Here, we developed novel mixed-effects models of the change in the perceived quality of arm movements during and following task practice. The models were fitted to data from a recent randomized controlled trial of the effect of dose of task practice in chronic stroke. Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice. Two additional effects modulated retention: a positive ""self-practice"" effect, and a negative effect of dose. Our results further suggest that for patients with sufficient arm use post-practice, self-practice will further improve use.",2020,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.",['chronic stroke'],[],"['Efficiency, Efficacy, and Retention of Task Practice in Chronic Stroke']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",[],"[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]",,0.0577901,"Analysis of the models' learning and retention rates demonstrated an increase in efficacy of practice with greater doses, a decrease in efficiency of practice with both additional dosages and additional bouts of training, and fast initial decay following practice.","[{'ForeName': 'Chunji', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Neuroscience Graduate Program, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Carolee', 'Initials': 'C', 'LastName': 'Winstein', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': ""D'Argenio"", 'Affiliation': 'Biomedical Engineering, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Schweighofer', 'Affiliation': 'Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948609']
1875,32843164,"Fixed-dose combination of indacaterol/glycopyrronium/mometasone furoate once-daily versus salmeterol/fluticasone twice-daily plus tiotropium once-daily in patients with uncontrolled asthma: A randomised, Phase IIIb, non-inferiority study (ARGON).","BACKGROUND
The efficacy and safety of once-daily (o.d.) fixed-dose combination of indacaterol (IND), glycopyrronium (GLY) and mometasone furoate (MF) via Breezhaler® versus concurrent administration of salmeterol/fluticasone (SAL/FLU) twice-daily (b.i.d.) via Accuhaler®+Tiotropium (TIO) o.d. via Respimat® was evaluated in patients with uncontrolled asthma.
METHODS
Patients (aged ≥18 years), symptomatic (Asthma Control Questionnaire [ACQ]-7 ≥1.5) despite treatment with long-acting β 2 -agonist/inhaled corticosteroid medium- or high-dose, received IND/GLY/MF high- (150/50/160 μg) or medium-dose (150/50/80 μg) o.d. or SAL/FLU high-dose (50/500 μg) b.i.d.+Tio 5 μg o.d. for 24 weeks. The primary objective was to confirm the non-inferiority of either dose of IND/GLY/MF to SAL/FLU high dose + TIO in terms of Asthma Quality of Life Questionnaire (AQLQ). Additional endpoints: ACQ-7, lung function, health status (St George's Respiratory Questionnaire [SGRQ]), exacerbations, and safety after 24 weeks.
RESULTS
IND/GLY/MF high- and medium-dose met the primary endpoint, confirming non-inferiority to SAL/FLU high dose + TIO for AQLQ (least square mean treatment difference [Δ]: 0.073 and -0.038, respectively; both p < 0.001). IND/GLY/MF high-dose improved ACQ-7 (Δ: -0.124; p = 0.004), trough FEV 1 (Δ: 96 mL; p < 0.001), peak expiratory flow (morning [Δ: 9.56 L/min; p = 0.005], evening [Δ: 9.15 L/min; p = 0.006]) and SGRQ (Δ: -2.00; p = 0.04) versus SAL/FLU high dose + TIO. Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO. Adverse events were generally comparable across treatments.
CONCLUSIONS
IND/GLY/MF high- and medium-dose o.d. via a single inhaler were non-inferior to SAL/FLU high-dose b.i.d. + TIO o.d. via two inhalers for AQLQ. IND/GLY/MF high-dose o.d. improved lung function, asthma control and health status versus SAL/FLU high dose + TIO, while IND/GLY/MF medium-dose had comparable efficacy but at a corresponding lower steroid dose.",2020,Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO.,"['Patients (aged ≥18 years), symptomatic (Asthma Control Questionnaire [ACQ]-7 ≥1.5) despite treatment with long-acting β 2 -agonist/inhaled corticosteroid medium- or high-dose, received IND/GLY/MF high', 'patients with uncontrolled asthma']","['indacaterol/glycopyrronium/mometasone furoate', 'salmeterol/fluticasone twice-daily plus tiotropium', 'indacaterol (IND), glycopyrronium (GLY) and mometasone furoate (MF) via Breezhaler®', 'salmeterol/fluticasone (SAL/FLU) twice-daily (b.i.d.) via Accuhaler®+Tiotropium (TIO', 'b.i.d.+Tio 5\xa0μg']","['Asthma Quality of Life Questionnaire (AQLQ', 'Adverse events', 'GLY/MF high-dose improved ACQ-7', ""ACQ-7, lung function, health status (St George's Respiratory Questionnaire [SGRQ]), exacerbations, and safety after 24 weeks"", 'peak expiratory flow', 'improved lung function, asthma control and health status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0066700', 'cui_str': 'Mometasone furoate'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.202799,Improvements in these endpoints were comparable for IND/GLY/MF medium-dose and SAL/FLU high dose + TIO.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gessner', 'Affiliation': 'Universitätsklinikum Leipzig, Germany POIS Leipzig GbR, Leipzig, Germany. Electronic address: studien@pois-le.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kornmann', 'Affiliation': 'IKF Pneumologie Frankfurt, Clinical Research Centre Respiratory Diseases, Frankfurt, Germany.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Zyl-Smit', 'Affiliation': 'Division of Pulmonology and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Krüll', 'Affiliation': 'Institut für Allergie- und Asthmaforschung Berlin, IAAB, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Salina', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pritam', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Novartis Healthcare Pvt. Ltd, Hyderabad, India.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bostel', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Fucile', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.'}, {'ForeName': 'Lorena Garcia', 'Initials': 'LG', 'LastName': 'Conde', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Pfister', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106021']
1876,32843512,Avoidance of Routine Endotracheal Suction in Subjects Ventilated for ≤ 12 Hours Following Elective Cardiac Surgery.,"BACKGROUND
Mechanical ventilation requires an endotracheal tube. Airway management includes endotracheal suctioning, a frequent procedure for patients in the ICU. Associated risks of endotracheal suctioning include hypoxia, atelectasis, and infection. There is currently no evidence about the safety of avoiding endotracheal suction. We aimed to assess the safety of avoiding endotracheal suction, including at extubation, in cardiac surgical patients who were mechanically ventilated for ≤ 12 h.
METHODS
We conducted a single-center, noninferiority, randomized controlled trial in a cardiac ICU in a metropolitan tertiary teaching hospital. Subjects were assigned to either avoidance of endotracheal suction or to usual care including endotracheal suctioning during mechanical ventilation. In total, we screened 468 patients and randomized 249 subjects (usual care, n = 125; intervention, n = 124). Subjects were elective cardiac surgical patients anticipated to receive ≤ 12 h of mechanical ventilation. The primary outcome was the [Formula: see text]/[Formula: see text] on room air 6 h after extubation, with a noninferiority margin of 10% (lower bound of one-sided 95% CI to be < 30).
RESULTS
There were no differences in group characteristics at baseline. The primary analysis was a per-protocol analysis performed on 154 subjects. The median [Formula: see text]/[Formula: see text] was 323 for the intervention group and 311 for the standard care group (median difference = 12, one-sided 95% CI -14.3). The results were consistent when using an intention-to-treat analysis and a 97.5% CI. There were no differences between groups in complications or safety measures, including the escalation of oxygen therapy.
CONCLUSIONS
Endotracheal suctioning can be safely minimized or avoided in low-risk patients who have had cardiac surgery and are expected to be ventilated for < 12 h after surgery.",2020,"The median P aO 2 /F IO 2 was 323 for the intervention group and 311 for the standard care group (median difference = 12, one-sided 95% CI -14.3).","['Subjects were elective cardiac surgical patients', 'patients in the ICU', 'cardiac surgical patients who were mechanically ventilated for ≤ 12 h', 'low-risk patients who have had cardiac surgery', 'Subjects Ventilated for ≤ 12 h Following Elective Cardiac Surgery', '468 patients and randomized 249 subjects (usual care, n = 125; intervention, n = 124', 'in a metropolitan tertiary teaching hospital']","['Routine Endotracheal Suction', 'mechanical ventilation', 'cardiac ICU', 'Endotracheal suctioning', 'avoidance of endotracheal suction or to usual care including endotracheal suctioning during mechanical ventilation', 'avoiding endotracheal suction']","['P aO 2 /F', 'Associated risks of endotracheal suctioning include hypoxia, atelectasis, and infection', 'median P aO 2 /F IO 2', 'escalation of oxygen therapy']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1522653', 'cui_str': 'Intratracheal route'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",249.0,0.205083,"The median P aO 2 /F IO 2 was 323 for the intervention group and 311 for the standard care group (median difference = 12, one-sided 95% CI -14.3).","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Gilder', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Grafton, Auckland, New Zealand. egilder@adhb.govt.nz.'}, {'ForeName': 'Shay P', 'Initials': 'SP', 'LastName': 'McGuinness', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Cavadino', 'Affiliation': 'School of Population Health, University of Auckland, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jull', 'Affiliation': 'School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit, Auckland City Hospital, Grafton, Auckland, New Zealand.'}]",Respiratory care,['10.4187/respcare.07821']
1877,32852421,"Influence of Topical Anesthesia on Superficial Sensitivity: A Double-Blind, Randomized, Placebo-Controlled Study on 48 Healthy Subjects.","BACKGROUND
Topical anesthetics are used in noninvasive transdermal anesthesia to decrease the superficial pain sensation threshold during dermatologic surgery. Combined pain relief and sensitivity loss can avoid discomfort during the surgery.
OBJECTIVE
The aim of this placebo-controlled study was to compare the efficacy of 3 commonly used topical agents by collating loss of sensitivity over time.
MATERIALS AND METHODS
Three topical anesthetic creams, a topical anti-inflammatory cream, and a moisturizing cream were applied on the left volar forearm of each of the 48 healthy Caucasian participants. Sensitivity was assessed with the dynamic 2-point discrimination and the Semmes-Weinstein test at 0, 60, 90, 120, 150, and 180 minutes after cream application.
RESULTS
After 180 minutes, benzocaine showed a significantly lower 2-point discrimination reduction than lidocaine alone and a lidocaine and prilocaine mixture. Sensory threshold measurements by the Semmes-Weinstein test after 60 minutes revealed a significantly higher effect with lidocaine alone and with the lidocaine and prilocaine mixture than with benzocaine.
CONCLUSION
The authors found a stronger skin sensitivity reduction by the eutectic lidocaine and prilocaine mixture and lidocaine alone compared with benzocaine. We suggest increased discomfort reduction in topical anesthetic supported dermatologic surgery by the eutectic mixture and lidocaine alone.",2020,"Sensory threshold measurements by the Semmes-Weinstein test after 60 minutes revealed a significantly higher effect with lidocaine alone and with the lidocaine and prilocaine mixture than with benzocaine.
","['48 healthy Caucasian participants', '48 Healthy Subjects']","['topical anti-inflammatory cream, and a moisturizing cream', 'lidocaine', 'prilocaine mixture and lidocaine', 'placebo', 'benzocaine', 'Placebo', 'prilocaine', 'Topical Anesthesia']","['superficial pain sensation', 'Sensitivity', 'skin sensitivity reduction', 'Superficial Sensitivity', 'discomfort reduction']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005059', 'cui_str': 'Benzocaine'}, {'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}]","[{'cui': 'C0234228', 'cui_str': 'Superficial pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0520898', 'cui_str': 'Skin sensitivity'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",48.0,0.201592,"Sensory threshold measurements by the Semmes-Weinstein test after 60 minutes revealed a significantly higher effect with lidocaine alone and with the lidocaine and prilocaine mixture than with benzocaine.
","[{'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Illg', 'Affiliation': '*All authors are affiliated with the Department of Hand, Plastic and Reconstructive Surgery, BG Unfallklinik Tuebingen, Eberhard Karls University Tuebingen, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Krauss', 'Affiliation': ''}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Kersten', 'Affiliation': ''}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Daigeler', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wenger', 'Affiliation': 'All authors are affiliated with the Department of Hand, Plastic and Reconstructive Surgery, BG Unfallklinik Tuebingen, Eberhard Karls University Tuebingen, Germany.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002608']
1878,32852426,"A Randomized, Split-Body, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Poly-L-lactic Acid for the Treatment of Upper Knee Skin Laxity.","BACKGROUND
Skin laxity of the upper knee and lower thigh is a common complaint among patients.
OBJECTIVE
This is a randomized, double-blinded, split-body, placebo-controlled study to evaluate the safety and efficacy of poly-L-lactic acid (PLLA) for treatment of upper knee skin laxity.
MATERIALS AND METHODS
Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled. The patients were randomized to receive 3 treatments of PLLA in 1 knee, whereas the other knee received 3 treatments of bacteriostatic water.
RESULTS
Statistically significant improvement as rated on the physician global aesthetic improvement scale was seen at Day 56 after final treatment in the active knee when compared with the placebo knee. This improvement was sustained at Day 84 and Day 168 after final treatment visits. No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale.
CONCLUSION
Based on our study, PLLA may be a safe and effective modality in addressing upper knee skin laxity. Larger studies with longer follow-up times and a validated knee laxity scale are needed to further determine if and how much improvement can be achieved.",2020,"No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale.
","['patients', 'Twenty female subjects between the ages of 30 and 65 years with upper knee laxity were enrolled', 'Upper Knee Skin Laxity', 'upper knee skin laxity']","['Poly-L-lactic Acid', 'PLLA', 'placebo', 'poly-L-lactic acid (PLLA', 'bacteriostatic water', 'Placebo']","['physician global aesthetic improvement scale', 'subject global aesthetic score or the subject satisfaction scale', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0222275', 'cui_str': 'Skin structure of knee'}]","[{'cui': 'C0525166', 'cui_str': 'Poly-L-lactic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",20.0,0.0421039,"No statistically significant difference was seen between the active and placebo knees on the subject global aesthetic score or the subject satisfaction scale.
","[{'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Kollipara', 'Affiliation': 'Westlake Dermatology & Cosmetic Surgery, Dallas, Texas.'}, {'ForeName': 'Elika', 'Initials': 'E', 'LastName': 'Hoss', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Boen', 'Affiliation': 'Cosmetic Laser Dermatology, San Diego, California.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Alhaddad', 'Affiliation': 'Slocum-Dickinson Medical Group, New Hartford, New York.'}, {'ForeName': 'Sabrina G', 'Initials': 'SG', 'LastName': 'Fabi', 'Affiliation': 'Cosmetic Laser Dermatology, San Diego, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002685']
1879,32852475,Reply: Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.,,2020,,[],['DIEP Flap and Fluorescent Angiography'],[],[],"[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0086305', 'cui_str': 'Angiography, Fluorescence'}]",[],,0.215261,,"[{'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Varela', 'Affiliation': 'Department of Plastic Surgery, Hospital Quiron Madrid-Pozuelo Fundación FIBHULP-IdiPaz, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Landin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007298']
1880,32852479,Outcomes of DIEP Flap and Fluorescent Angiography: A Randomized Controlled Clinical Trial.,,2020,,[],['DIEP Flap and Fluorescent Angiography'],[],[],"[{'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0086305', 'cui_str': 'Angiography, Fluorescence'}]",[],,0.188824,,"[{'ForeName': 'Ziying', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Aesthetic and Reconstructive Breast Surgery, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Chenglong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Minqiang', 'Initials': 'M', 'LastName': 'Xin', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000007297']
1881,32857301,Comparing outcomes of hospitalized patients with moderate and severe COVID-19 following treatment with hydroxychloroquine plus atazanavir/ritonavir.,"BACKGROUND
The role of the antiviral therapy in treatment of COVID-19 is still a matter to be investigated. Also efficacy and safety of antiviral regimens were not compared according severity of the disease. In this study the efficacy and safety of hydroxychloroquine plus atazanavir/ritonavir was compared in patients with moderate and severe COVID-19.
METHODS
We prospectively evaluated the clinical outcomes of 213 patients with COVID-19 during the hospitalization course and up to 56 days after the hospital discharge. The disease was categorized to moderate and severe based on the severity of pneumonia and peripheral oxygen saturation (SpO2). The patients received the national treatment protocol containing hydroxychloroquine (400 mg BD in first day and then 200 mg BD) plus atazanavir/ritonavir (300/100 mg daily) for 7 days. Main outcomes included discharge rates at day 7, 14 and 28, 28-day mortality, rate of intensive care unit (ICU) admission and intubation, length of hospital and ICU stay and incidence of adverse events.
RESULTS
The mean (SD) age of patients was 60(14) years and 53% were male. According to WHO definition, 51.64% and 48.36% of the patients had moderate (SpO2 ≥ 90%) and severe disease (SpO2 < 90%) at baseline, respectively. The discharge rate of the moderate group was significantly higher than the severe group at day 7, 14 and 28 (HR = 0.49; 95% CI: 0.35-0.69, p = < 0.001 at day 7, HR = 0.48; 95% CI: 0.35-0.66, p = < 0.001 at day 14 and HR = 0.49; 95% CI: 0.36-0.67, p = < 0.001at day 28). The 28-day mortality of the severe group was six times higher than the moderate group (HR = 6.00; 95% CI: 2.50-14.44), p = < 0.001). The need of admission in ICU for the severe group and the moderate group was 37.86% and 18.18% of the patients. Length of hospital stay was significantly shorter in the moderate group in comparison with the severe group (5 ± 4 vs. 8 ± 6 days, p < 0.001). Patients in the moderate group experienced the serious adverse events and complications less than the severe group. The discharged patients were followed up to 56 days after discharge. Some of the patients complained of symptoms such as exertional dyspnea, weakness and new-onset hair loss.
CONCLUSION
Our study did not support the use of hydroxychloroquine plus atazanavir/ritonavir in patients who had SpO 2 < 90% at the time of hospital admission. SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.",2020,"SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.","['hospitalized patients with moderate and severe COVID-19 following treatment with', 'The mean (SD) age of patients was 60(14) years and 53% were male', 'patients who had SpO 2 \u2009<\u200990% at the time of hospital admission', 'patients with moderate and severe COVID-19', '213 patients with COVID-19 during the hospitalization course and up to 56\xa0days after the hospital discharge']","['hydroxychloroquine', 'atazanavir/ritonavir', 'hydroxychloroquine plus atazanavir/ritonavir']","['serious adverse events and complications', 'discharge rate', 'efficacy and safety', 'Length of hospital stay', '28-day mortality', 'exertional dyspnea, weakness and new-onset hair loss', 'clinical outcomes (duration of hospital stay, discharge from the hospital and mortality', 'discharge rates at day 7, 14 and 28, 28-day mortality, rate of intensive care unit (ICU) admission and intubation, length of hospital and ICU stay and incidence of adverse events', 'severity of pneumonia and peripheral oxygen saturation (SpO2', 'severe disease']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",213.0,0.133007,"SpO2 was the only predictor of clinical outcomes (duration of hospital stay, discharge from the hospital and mortality) in patients treated with hydroxychloroquine plus atazanavir/ritonavir.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahid', 'Initials': 'A', 'LastName': 'Nourian', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Nabiee', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Setayesh', 'Initials': 'S', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. khalilih@tums.ac.ir.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Abbasian', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Ghiasvand', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Seifi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Hasannezhad', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ghaderkhani', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Intensive Care Unit, Imam Khomeini Hospital Complex, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public health, Tehran University of Medical Sciences, Tehran, Iran.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00369-2']
1882,32857315,"Single-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites Alone and in Combination with Gemfibrozil, Itraconazole, or Rifampin in Healthy Subjects: A Randomized, Parallel-Group, Open-Label Study.","INTRODUCTION
The aims of this study were to characterize the single-dose pharmacokinetics (PK) of the major active metabolites of ozanimod, CC112273 and CC1084037, and to evaluate the effect of gemfibrozil (a strong inhibitor of cytochrome P450 [CYP] 2C8), itraconazole (a strong inhibitor of CYP3A and P-glycoprotein [P-gp]), and rifampin (a strong inducer of CYP3A/P-gp and moderate inducer of CYP2C8) on the single-dose PK of ozanimod and its major active metabolites in healthy subjects.
METHODS
This was a phase 1, randomized, parallel-group, open-label study with two parts. In part 1, 40 subjects were randomized to receive a single oral dose of ozanimod 0.46 mg (group A, n = 20) or oral doses of gemfibrozil 600 mg twice daily for 17 days with a single oral dose of ozanimod 0.46 mg on day 4 (group B, n = 20). In part 2, 60 subjects were randomized to receive a single oral dose of ozanimod 0.92 mg (group C, n = 20), oral doses of itraconazole 200 mg once daily for 17 days with a single oral dose of ozanimod 0.92 mg on day 4 (group D, n = 20), or oral doses of rifampin 600 mg once daily for 21 days with a single oral dose of ozanimod 0.92 mg on day 8 (group E, n = 20). Plasma PK parameters for ozanimod, CC112273, and CC1084037 were estimated using noncompartmental methods.
RESULTS
Dose-proportional increases in maximum observed concentration (C max ) and area under the concentration-time curve (AUC) were observed for ozanimod, CC112273, and CC1084037. The mean terminal elimination half-life (t 1/2 ) for ozanimod was approximately 20-22 h while the mean t 1/2 for CC112273 and CC1084037 were approximately 10 days. CC112273 and CC1084037 exposures were highly correlated with or without interacting drugs. Itraconazole increased ozanimod AUC by approximately 13% while rifampin reduced ozanimod AUC by approximately 24%, suggesting a minor role of CYP3A and P-gp in the overall disposition of ozanimod. Gemfibrozil increased the AUC for CC112273 and CC1084037 by approximately 47% and 69%, respectively. Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
CONCLUSIONS
Ozanimod's major active metabolites, CC112273 and CC1084037, exhibited similar single-dose PK properties and their exposures were highly correlated. CYP2C8 is one of the important enzymes in the overall disposition of CC112273 and subsequently its direct metabolite CC1084037.
TRIAL REGISTRATION
Clinical trial: NCT03624959.",2020,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
","['In part\xa02, 60 subjects', '40 subjects', 'healthy subjects', 'Healthy Subjects']","['itraconazole', 'ozanimod 0.46\xa0mg (group\xa0A, n\u2009=\u200920) or oral doses of gemfibrozil 600\xa0mg twice daily for 17\xa0days with a single oral dose of ozanimod 0.46\xa0mg on day\xa04', 'Ozanimod', 'Itraconazole', 'ozanimod', 'gemfibrozil', 'rifampin 600\xa0mg once daily for 21\xa0days with a single oral dose of ozanimod 0.92', 'Gemfibrozil', 'Gemfibrozil, Itraconazole, or Rifampin', 'ozanimod 0.92']","['Plasma PK parameters', 'ozanimod AUC', 'maximum observed concentration (C max ) and area under the concentration-time curve (AUC', 'mean terminal elimination half-life', 'AUC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C4517460', 'cui_str': '0.46'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0993358', 'cui_str': 'Gemfibrozil 600 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017245', 'cui_str': 'Gemfibrozil'}, {'cui': 'C1104996', 'cui_str': 'Rifampin 600 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517485', 'cui_str': '0.92'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}]",40.0,0.103499,"Rifampin reduced the AUC for CC112273 and CC1084037, primarily via CYP2C8 induction, by approximately 60% and 55%, respectively.
","[{'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA. dr.jtran@gmail.com.'}, {'ForeName': 'Peijin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Liangang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Biometrics and Data Science, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Syto', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Nonclinical Research and Development, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01473-0']
1883,32860109,Antibiotic prophylaxis in acute cholecystectomy revisited: results of a double-blind randomised controlled trial.,"PURPOSE
Evidence supporting the value of preoperative antibiotic prophylaxis (PAP) in surgery for acute cholecystitis is lacking. This study aimed to shed light on whether PAP in acute cholecystectomy for cholecystitis reduces the postoperative infectious complication (PIC) rate. Secondary outcomes were the prevalence of bacteriobilia, CRP values and leucocyte counts.
METHODS
The study was performed as a single-centre, double-blinded, placebo-controlled, randomised study. Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy were randomly assigned to either PAP (piperacillin/ tazobactam) or placebo, and the subsequent clinical course was followed.
RESULTS
A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation. PIC developed in 22 of the 90 patients included with no significant difference between the PAP and placebo groups (8 patients in the PAP group and 14 in the placebo arm, p = 0.193). The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups.
CONCLUSION
PAP does not affect the risk for PIC in patients with acute cholecystitis. The major risk factors determining PIC in these patients need defining, in particular, the impact of bacteriobilia.
TRIAL REGISTRATION
The study was registered at clinicaltrials.gov (NCT02619149) December 2, 2015.",2020,"The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups.
","['Patients with acute cholecystitis amenable for acute laparoscopic cholecystectomy', 'A total of 106 patients were enrolled, 16 of whom were excluded due to protocol violation', 'patients with acute cholecystitis', 'acute cholecystectomy revisited']","['placebo', 'preoperative antibiotic prophylaxis (PAP', 'PAP (piperacillin/ tazobactam) or placebo', 'Antibiotic prophylaxis']","['risk for PIC', 'PIC', 'postoperative infectious complication (PIC) rate', 'PIC rate', 'prevalence of bacteriobilia, CRP values and leucocyte counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0075870', 'cui_str': 'tazobactam'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]",106.0,0.562603,"The PIC rate was significantly higher in patients with a raised CRP at randomisation and on the day of surgery and in cases of conversion to an open procedure (p = 0.008, 0.004 and 0.017, respectively) but with no differences between the study groups.
","[{'ForeName': 'Gona', 'Initials': 'G', 'LastName': 'Jaafar', 'Affiliation': 'Subject Trauma Reparative Medicine, CLINTEC, Karolinska University Hospital, 14186, Stockholm, Sweden.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sandblom', 'Affiliation': 'Department of Clinical Science and Education, Department of Surgery, Södersjukhuset, Karolinska Institute, Stockholm, Sweden. gabriel.sandblom@ki.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lundell', 'Affiliation': 'Department of Surgery, CLINTEC, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Folke', 'Initials': 'F', 'LastName': 'Hammarqvist', 'Affiliation': 'Subject Trauma Reparative Medicine, CLINTEC, Karolinska University Hospital, 14186, Stockholm, Sweden.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01977-x']
1884,32833919,Placental lipid metabolism in preeclampsia.,"OBJECTIVES
The current study examines the placental and maternal lipid profile and expression of genes involved in placental lipid metabolism in women with preeclampsia.
METHODS
The current study includes normotensive control women (n = 40) and women with preeclampsia (n = 39). Preeclampsia women were further classified into women delivering at term preeclampsia (T-PE; n = 15) and preterm preeclampsia (PT-PE; n = 24).
RESULTS
There were no significant differences in maternal lipid profile between the T-PE and normotensive control groups. Maternal plasma VLDL (P < 0.05) and ratios of total cholesterol : HDL (P < 0.05), atherogenic index [log (triglycerides/HDL)] (P < 0.01) and apolipoprotein B : apolipoprotein A (P < 0.05) were higher in the PT-PE group as compared with the normotensive control group. Placental total cholesterol and HDL levels were higher (P < 0.05) in the T-PE as compared with the normotensive control group. Higher placental triglycerides (P < 0.05) were observed in PT-PE group compared with T-PE group. Placental mRNA levels of peroxisome proliferator activated receptor α, carnitine palmitoyl transferase-1, cluster of differentiation 36 and lipoprotein lipases were lower (P < 0.05) in the PT-PE than normotensive control group. A negative association of mRNA levels of peroxisome proliferator activated receptor α (r = -0.246, P = 0.032; r = -0.308, P = 0.007, respectively), carnitine palmitoyl transferase-1 (r = -0.292, P = 0.011; r = -0.366, P = 0.001), lipoprotein lipases (r = -0.296, P = 0.010; r = -0.254, P = 0.028) with SBP and DBP was observed. There was a positive association of placental triglycerides (r = 0.244, P = 0.031) with DBP.
CONCLUSION
Women with preeclampsia exhibit higher lipid : lipoprotein ratios suggesting an atherogenic state particularly in women delivering preterm. Lower expression of genes involved in placental fatty acid oxidation and transport was also observed in preeclampsia.",2021,Higher placental triglycerides (P < 0.05) were observed in PT-PE group compared with T-PE group.,"['Women with preeclampsia exhibit higher lipid\u200a', 'women with preeclampsia', 'normotensive control women (n\u200a=\u200a40) and women with preeclampsia (n\u200a=\u200a39', 'Preeclampsia women were further classified into women delivering at term preeclampsia (T-PE; n\u200a=\u200a15) and preterm preeclampsia (PT-PE; n\u200a=\u200a24', 'preeclampsia']",[],"['placental fatty acid oxidation and transport', 'Higher placental triglycerides', 'SBP and DBP', 'placental triglycerides', 'atherogenic index [log (triglycerides/HDL', 'Placental lipid metabolism', 'placental lipid metabolism', 'Placental mRNA levels of peroxisome proliferator activated receptor α, carnitine palmitoyl transferase-1, cluster of differentiation 36 and lipoprotein lipases', 'ratios of total cholesterol\u200a:\u200aHDL', 'maternal lipid profile', 'Maternal plasma VLDL', 'Placental total cholesterol and HDL levels', 'lipoprotein lipases', 'carnitine palmitoyl transferase-1 ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0851043', 'cui_str': 'Increased lipid'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",[],"[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0007258', 'cui_str': 'Carnitine'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0023816', 'cui_str': 'Lipoprotein lipase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}]",,0.0384321,Higher placental triglycerides (P < 0.05) were observed in PT-PE group compared with T-PE group.,"[{'ForeName': 'Amrita A', 'Initials': 'AA', 'LastName': 'Khaire', 'Affiliation': 'Mother and Child Health, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University).'}, {'ForeName': 'Shivani R', 'Initials': 'SR', 'LastName': 'Thakar', 'Affiliation': 'Mother and Child Health, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University).'}, {'ForeName': 'Girija N', 'Initials': 'GN', 'LastName': 'Wagh', 'Affiliation': 'Department of Obstetrics and Gynecology, Bharati Medical College and Hospital, Bharati Vidyapeeth University, Pune, India.'}, {'ForeName': 'Sadhana R', 'Initials': 'SR', 'LastName': 'Joshi', 'Affiliation': 'Mother and Child Health, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be University).'}]",Journal of hypertension,['10.1097/HJH.0000000000002596']
1885,32841937,Elimination of Benign Ventricular Premature Beats or Ventricular Tachycardia with Catheter Ablation versus Two Different Optimal Antiarrhythmic Drug Treatment Regimens (Sotalol or Verapamil/Flecainide).,"BACKGROUND
Symptomatic idiopathic ventricular arrhythmias (VA), including premature beats (VPB) and nonsustained ventricular tachycardia (VT) are commonly encountered arrhythmias. Although these VA are usually benign, their treatment can be a challenge to primary and secondary health care providers. Mainstay treatment is comprised of antiarrhythmic drugs (AAD) and, in case of drug intolerance or failure, patients are referred for catheter ablation to tertiary health care centers. These patients require extensive medical attention and drug regimens usually have disappointing results. A direct comparison between the efficacy of the most potent AAD and primary catheter ablation in these patients is lacking. The ECTOPIA trial will evaluate the efficacy of 2 pharmacological strategies and 1 interventional approach to: suppress the VA burden, improve the quality of life (QoL), and safety.
HYPOTHESIS
We hypothesize that flecainide/verapamil combination and catheter ablation are both superior to sotalol in suppressing VA in patients with symptomatic idiopathic VA.
STUDY DESIGN
The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil. One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden ≥5% on 24-h ambulatory rhythm monitoring will be included. Patients will be randomized in a 1:1:1 fashion. The primary endpoint is defined as >80% reduction of the VA burden on 24-h ambulatory Holter monitoring. After reaching the primary endpoint, patients randomized to one of the 2 AAD arms will undergo a cross-over to the other AAD treatment arm to explore differences in drug efficacy and QoL in individual patients. Due to the use of different AAD (with and without β-blocking characteristics) we will be able to explore the influence of alterations in sympathetic tone on VA burden reduction in different subgroups. Finally, this study will assess the safety of treatment with 2 different AAD and ablation of VA.",2020,"The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil.","['patients with symptomatic idiopathic VA', 'One hundred eighty patients with frequent symptomatic VA in the absence of structural heart disease or underlying cardiac ischemia who are eligible for catheter ablation with an identifiable monomorphic VA origin with a burden']","['flecainide/verapamil combination and catheter ablation', 'primary catheter ablation', 'catheter ablation', 'Ventricular Tachycardia with Catheter Ablation versus Two Different Optimal Antiarrhythmic Drug Treatment Regimens (Sotalol or Verapamil/Flecainide', 'sotalol', 'sotalol or flecainide/verapamil', 'AAD (with and without β-blocking characteristics']","['quality of life (QoL), and safety', 'drug efficacy and QoL', 'VA burden on 24-h ambulatory Holter monitoring', '24-h ambulatory rhythm monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0016229', 'cui_str': 'Flecainide'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0037707', 'cui_str': 'Sotalol'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]",180.0,0.056817,"The Elimination of Ventricular Premature Beats with Catheter Ablation versus Optimal Antiarrhythmic Drug Treatment (ECTOPIA) trial is a randomized, multicenter, prospective clinical trial to compare the efficacy of catheter ablation versus optimal AAD treatment with sotalol or flecainide/verapamil.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Haanschoten', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Vernooy', 'Affiliation': 'Maastricht UMC+, Maastricht, The Netherlands.'}, {'ForeName': 'Rypko J', 'Initials': 'RJ', 'LastName': 'Beukema', 'Affiliation': 'Radboud UMC, Nijmegen, The Netherlands.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Szili-Torok', 'Affiliation': 'Erasmus UMC, Rotterdam, The Netherlands.'}, {'ForeName': 'Rachel M A', 'Initials': 'RMA', 'LastName': 'Ter Bekke', 'Affiliation': 'Maastricht UMC+, Maastricht, The Netherlands.'}, {'ForeName': 'Muchtiar', 'Initials': 'M', 'LastName': 'Khan', 'Affiliation': 'OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Jonas S S G', 'Initials': 'JSSG', 'LastName': 'de Jong', 'Affiliation': 'OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Otten', 'Affiliation': 'Gelre Ziekenhuizen, Apeldoorn, The Netherlands.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Adiyaman', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Jaap Jan J', 'Initials': 'JJJ', 'LastName': 'Smit', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Peter Paul H M', 'Initials': 'PPHM', 'LastName': 'Delnoy', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Anand R', 'Initials': 'AR', 'LastName': 'Ramdat Misier', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Isala Heart Center, Zwolle, The Netherlands, a.elvan@isala.nl.'}]",Cardiology,['10.1159/000509661']
1886,32843021,"Efficacy of a smartphone-based intervention - ""Holidaily"" - promoting recovery behaviour in workers after a vacation: study protocol for a randomised controlled trial.","BACKGROUND
While work-related rumination increases the risk of acute stressors developing into chronic load reactions and adverse health, mental detachment has been suggested as a way to interrupt this chain. Despite the importance of mentally detaching from work during leisure time, workers seem to struggle to disengage and, instead, experience the constant mental representation of work-related stressors, regardless of their absence. Those who struggle with work-related rumination could benefit from an easy-access intervention that fosters mental detachment by promoting recreational activities. Especially during vacations, workers appear to naturally engage in sufficient recovery activities; however, this beneficial behaviour is not sustained. The smartphone app-based intervention ""Holidaily"" promotes recovery behaviour and, thus, mental detachment from work with the intension of extending the beneficial effects of workers' vacations into their daily working life.
METHODS
This randomised-controlled trial (RCT) evaluates the efficacy of ""Holidaily"". The Holidaily app is a German stand-alone program for mobile devices with either Android/iOS operating systems. The sample includes workers, who are awaiting to go on vacation and are randomly assigned to either the intervention (IG) or a waitlist-control group (CG). The IG receives two weeks pre-vacation access to Holidaily, while the CG receives access two weeks post-vacation. On a daily basis participants in the IG are provided with three options promoting recreational activities and beneficial recovery experiences. Online questionnaires are distributed to all participants at several timepoints. The primary outcome measure assesses participants' work-related rumination (Irritation Scale). A significant difference two weeks post-vacation is expected, favouring the IG. Secondary outcomes include symptoms of depression, insomnia severity, emotional exhaustion, thinking about work, recovery experiences, vacation specifics, work and personal characteristics. To help explain the intervention's effect, explorative analyses will investigate the mediation properties of the frequency of engaging in recreational activities and the moderation properties of Holidaily users' experiences.
DISCUSSION
If successful, workers will maintain their recovery behaviour beyond their vacation into daily working life. Findings could, therefore, provide evidence for low-intensity interventions that could be very valuable from a public-health perspective. App-based interventions have greater reach; hence, more workers might access preventative tools to protect themselves from developing adverse health effects linked to work-related rumination. Further studies will still be needed to investigate whether the vacation phenomenon of ""lots of fun quickly gone"" can be defied and long-term benefits attained.
TRIAL REGISTRATION
German Clinical Trials Registration DRKS00013650 . Registered retrospectively 15.01.2018.",2020,The Holidaily app is a German stand-alone program for mobile devices with either Android/iOS operating systems.,"['workers after a vacation', 'sample includes workers, who are awaiting to go on vacation']","['Holidaily', 'smartphone-based intervention - ""Holidaily"" ', 'waitlist-control group (CG']","[""participants' work-related rumination (Irritation Scale"", 'symptoms of depression, insomnia severity, emotional exhaustion, thinking about work, recovery experiences, vacation specifics, work and personal characteristics']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",3.0,0.16874,The Holidaily app is a German stand-alone program for mobile devices with either Android/iOS operating systems.,"[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Smyth', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany. alexandra.smyth@stud.leuphana.de.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'de Bloom', 'Affiliation': 'Department of Human Resource Management and Organizational Behavior, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Syrek', 'Affiliation': 'Department of Occupational Psychology, University of Applied Sciences Bonn-Rhein Sieg, Rheinbach, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Domin', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Janneck', 'Affiliation': 'Department of Electrical Engineering and Computer Science, Technische Hochschule Luebeck, Luebeck, Germany.'}, {'ForeName': 'Jo Annika', 'Initials': 'JA', 'LastName': 'Reins', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Lehr', 'Affiliation': 'Department of Health Psychology and Applied Biological Psychology, Institute of Psychology, Leuphana University of Lueneburg, Universitaetsallee 1, 21335, Lueneburg, Germany.'}]",BMC public health,['10.1186/s12889-020-09354-5']
1887,32846334,Effectiveness of pulmonary rehabilitation at high-altitude compared to sea-level in adults with severe refractory asthma.,"BACKGROUND
Beneficial effects of pulmonary rehabilitation at high-altitude (HAPR) in patients with severe refractory asthma have been reported earlier, but evidence for the effectiveness is limited.
AIM
To investigate the effectiveness of high-altitude pulmonary rehabilitation to comparable treatment at sea-level (LAPR) on patient outcome parameters.
METHODS
Adults with severe refractory asthma living in The Netherlands were included. Treatment consisted of a 12-week personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n = 93) or in a tertiary lung center at sea-level in The Netherlands (n = 45). At baseline, after treatment, and during 12 months follow-up asthma related quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose were assessed. Patients could not be randomized resulting in different asthma populations. Groups were compared using linear regression analysis (ANCOVA) adjusted for baseline values, in addition to age, atopy, smoking history, BMI and gender.
RESULTS
After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear regression analysis-5.29 mg, p = 0.003 and Crude Odds Ratio-1.67, p = 0.003, respectively) were observed in the HAPR-group compared to the LAPR group. Patients receiving HAPR also had less asthma exacerbations (≥1 exacerbation: 20% vs 60%,p < 0.001) and showed improvement in lung function (%predFEV 1 3.4%,p = 0.014) compared to the LAPR group, but at 12 months no differences between groups were observed.
CONCLUSION
HAPR resulted in a larger improvement in patient outcome parameters compared to LAPR, on the long run the improvement in patient reported symptoms and lower maintenance OCS-dose persists. Underlying factors that explain this observed effect need to be investigated.",2020,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","['patients with severe refractory asthma', 'adults with severe refractory asthma', 'Adults with severe refractory asthma living in The Netherlands were included']","['personalized multidisciplinary rehabilitation program either at high-altitude (Davos Switzerland) (n\xa0=\xa093) or in a tertiary lung center at sea-level in The Netherlands', 'pulmonary rehabilitation at high-altitude (HAPR', 'HAPR', 'high-altitude pulmonary rehabilitation', 'pulmonary rehabilitation']","['asthma exacerbations', 'lung function', 'quality of life (AQLQ), asthma control (ACQ), pulmonary function and OCS-dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",,0.06858,"After treatment, and at 12 months follow-up, improved AQLQ(0.92,p < 0.001 and 0.82,p = 0.001, respectively), ACQ(-0.87,p < 0.001 and -0.69,p = 0.008, respectively) and lower maintenance OCS dose (Unadjusted linear","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'de Nijs', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands; Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Krop', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Portengen', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Rijssenbeek-Nouwens', 'Affiliation': 'Dutch Asthma Center Davos, Davos, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'de Vries', 'Affiliation': 'Merem Asthma Center Heideheuvel, Hilversum, the Netherlands.'}, {'ForeName': 'E J M', 'Initials': 'EJM', 'LastName': 'Weersink', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam University Medical Center, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'H G M', 'Initials': 'HGM', 'LastName': 'Heijerman', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands. Electronic address: H.G.M.Heijerman@umcutrecht.nl.'}, {'ForeName': 'D J J', 'Initials': 'DJJ', 'LastName': 'Heederik', 'Affiliation': 'Institute for Risk Assessment Sciences, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'J W J', 'Initials': 'JWJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Respiratory Medicine, University Medical Center Utrecht, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106123']
1888,32857471,"Efficacy and tolerability of low-dose spironolactone and topical benzoyl peroxide in adult female acne: A randomized, double-blind, placebo-controlled trial.","Effective therapies for adult female acne (AFA) are limited. Oral spironolactone (SPL), 100-200 mg/day, is currently used off-label to treat AFA. However, high-dose SPL results in clinically significant side-effects which prevent widespread use in clinical practice. The efficacy of low-dose spironolactone in AFA is unknown. We examined the efficacy and tolerability of low-dose (25-50 mg/day) oral SPL in Thai women with moderate AFA. A randomized, double-blind, placebo-controlled trial was conducted for 12 weeks. Moderate AFA patients aged between 25 and 45 years received a combination of daily topical benzoyl peroxide (BP) 2.5% plus either SPL 25 mg (SPL25 group), SPL 50 mg (SPL50 group) or placebo. We performed total acne counts and Adult Female Acne Scoring Tool (AFAST) grading at 4-week intervals. The success rate, defined as the proportion of participants achieving a ""clear/almost clear"" AFAST grade by the end of week 12, was considered as the main outcome. Treatment-related adverse events (TRAE) were recorded. We enrolled 63 participants in the study. The total acne counts decreased significantly in all three groups (P < 0.05) as compared with baseline. Participants in the SPL50 group had a significantly higher success rate than those in the placebo group (P < 0.05). Serum potassium and creatinine levels showed no significant changes with treatment or between groups. A small number of participants in SPL25 and SPL50 reported mild and temporary TRAE, such as menstrual irregularities, breast tenderness and dizziness. The combination of SPL 50 mg/day and topical BP proved effective in improving moderate AFA in Thai women, with an acceptable side-effect profile. We propose this regimen as an option for treating moderate AFA.",2020,Participants in the SPL50 group had a significantly higher success rate than those in the placebo group (P < 0.05).,"['adult female acne (AFA', '63 participants in the study', 'Thai women with moderate AFA', 'adult female acne', 'Moderate AFA patients aged between 25 and 45\xa0years']","['Oral spironolactone (SPL', 'combination of daily topical benzoyl peroxide (BP) 2.5% plus either SPL 25\xa0mg (SPL25 group), SPL 50\xa0mg (SPL50 group) or placebo', 'spironolactone', 'placebo', 'low-dose spironolactone and topical benzoyl peroxide', 'low-dose (25-50\xa0mg/day) oral SPL', 'SPL']","['Efficacy and tolerability', 'Serum potassium and creatinine levels', 'success rate', 'Treatment-related adverse events (TRAE', 'success rate, defined as the proportion of participants achieving a ""clear/almost clear"" AFAST grade', 'total acne counts', 'moderate AFA', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0005088', 'cui_str': 'Benzoyl Peroxide'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0990353', 'cui_str': 'Spironolactone 25 MG'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0992989', 'cui_str': 'Spironolactone 50 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",63.0,0.389296,Participants in the SPL50 group had a significantly higher success rate than those in the placebo group (P < 0.05).,"[{'ForeName': 'Mattana', 'Initials': 'M', 'LastName': 'Patiyasikunt', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Bussabong', 'Initials': 'B', 'LastName': 'Chancheewa', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nopadon', 'Initials': 'N', 'LastName': 'Noppakun', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Chanat', 'Initials': 'C', 'LastName': 'Kumtornrut', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}]",The Journal of dermatology,['10.1111/1346-8138.15559']
1889,32860034,Time-to-treatment initiation of colchicine and cardiovascular outcomes after myocardial infarction in the Colchicine Cardiovascular Outcomes Trial (COLCOT).,"AIMS
The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated the benefits of targeting inflammation after myocardial infarction (MI). We aimed to determine whether time-to-treatment initiation (TTI) influences the beneficial impact of colchicine.
METHODS AND RESULTS
In COLCOT, patients were randomly assigned to receive colchicine or placebo within 30 days post-MI. Time-to-treatment initiation was defined as the length of time between the index MI and the initiation of study medication. The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The relationship between endpoints and various TTI (<3, 4-7 and >8 days) was examined using multivariable Cox regression models. Amongst the 4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata. After a median follow-up of 22.7 months, there was a significant reduction in the incidence of the primary endpoint for patients in whom colchicine was initiated < Day 3 compared with placebo [hazard ratios (HR) = 0.52, 95% confidence intervals (CI) 0.32-0.84], in contrast to patients in whom colchicine was initiated between Days 4 and 7 (HR = 0.96, 95% CI 0.53-1.75) or > Day 8 (HR = 0.82, 95% CI 0.61-1.11). The beneficial effects of early initiation of colchicine were also demonstrated for urgent hospitalization for angina requiring revascularization (HR = 0.35), all coronary revascularization (HR = 0.63), and the composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke (HR = 0.55, all P < 0.05).
CONCLUSION
Patients benefit from early, in-hospital initiation of colchicine after MI.
TRIAL REGISTRATION
COLCOT ClinicalTrials.gov number, NCT02551094.",2020,"The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization.","['4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata']","['colchicine or placebo', 'colchicine', 'placebo']","['composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization', 'urgent hospitalization for angina requiring revascularization', 'composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",4661.0,0.451585,"The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization.","[{'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bouabdallaoui', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Waters', 'Affiliation': 'San Francisco General Hospital, California.'}, {'ForeName': 'Fausto J', 'Initials': 'FJ', 'LastName': 'Pinto', 'Affiliation': 'Santa Maria University Hospital (CHULN), CAML, CCUL, Faculdade de Medicina da Universidade de Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Firenze, Italy.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clinicos Latinoamerica, Rosario, Argentina.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'University of Glasgow and NHS Glasgow Clinical Research Facility, Glasgow, UK.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Koenig', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Sendon', 'Affiliation': 'H La Paz, IdiPaz, UAM, Ciber-CV Madrid, Spain.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Gamra', 'Affiliation': 'Fattouma Bourguiba University Hospital, Monastir, Tunisia.'}, {'ForeName': 'Ghassan S', 'Initials': 'GS', 'LastName': 'Kiwan', 'Affiliation': 'Bellevue Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Blondeau', 'Affiliation': 'The Montreal Health Innovations Coordinating Center (MHICC), Montreal, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Orfanos', 'Affiliation': 'The Montreal Health Innovations Coordinating Center (MHICC), Montreal, Canada.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Grégoire', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Dubé', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Samuel', 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Morel', 'Affiliation': 'Division of Cardiovascular Medicine, Nouvel Hôpital Civil, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Lim', 'Affiliation': 'Department of Cardiology, AP-HP, Hôpital Universitaire Henri-Mondor and INSERM U955, Université Paris-Est Créteil, Créteil, France.'}, {'ForeName': 'Olivier F', 'Initials': 'OF', 'LastName': 'Bertrand', 'Affiliation': 'Institut de Cardiologie et Pneumologie de Québec, Quebec City, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kouz', 'Affiliation': 'Centre Hospitalier Régional de Lanaudière, Joliette, Canada.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Guertin', 'Affiliation': 'The Montreal Health Innovations Coordinating Center (MHICC), Montreal, Canada.'}, {'ForeName': 'Philippe L', 'Initials': 'PL', 'LastName': ""L'Allier"", 'Affiliation': 'Montreal Heart Institute, 5000 Belanger Street, Montreal, Quebec H1T 1C8, Canada and Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Université de Montpellier, INSERM, CNRS, CHU de Montpellier, France.'}]",European heart journal,['10.1093/eurheartj/ehaa659']
1890,32871505,Social support modifies the association between hazardous drinking and depression symptoms among ART clients in Vietnam.,"INTRODUCTION
Hazardous drinking is widespread among people with HIV (PWH). PWH are also vulnerable to depression due to HIV-related social stigma, and social support can play an important role in improving mental health for this population. No studies have explored whether social support modifies the association of hazardous drinking and depressive symptoms among PWH.
METHODS
We used baseline data from a randomized controlled trial of two evidence-based alcohol reduction interventions among antiretroviral therapy clients in Vietnam. Hazardous alcohol use was defined as having a score ≥8 for men and ≥ 7 for women on the Alcohol Use Disorders Identification Test. The presence of depression symptoms was defined as a score ≥ 5 on the Patient Health Questionnaire-9. Social support was measured with a 5-question modified version of the Medical Outcomes Study Social Support Instrument. Crude (CPRs) and adjusted prevalence ratios (aPRs) of the association were presented.
RESULTS
Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52). Hazardous drinking and depression symptoms were not associated among those with high social support (aPR = 1.01;95%CI 0.76-1.35), but were associated among those with medium (aPR = 1.24;95%CI 0.92-1.69) and low social support (aPR = 1.71;95%CI 1.25-2.34).
CONCLUSIONS
Social support significantly modified the association between hazardous drinking and depression symptoms among ART clients in Vietnam. Interventions to decrease hazardous alcohol use are broadly indicated for PWH in Vietnam and other low-resource settings, but special attention or modifications may be needed to support mental health among those with lower levels of social support.",2020,"RESULTS
Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52).","['ART clients in Vietnam', 'people with HIV (PWH', 'antiretroviral therapy clients in Vietnam']",['evidence-based alcohol reduction interventions'],"['Hazardous drinking and depression symptoms', 'depression symptoms', 'hazardous drinking and depression symptoms', 'Crude (CPRs) and adjusted prevalence ratios (aPRs', 'likelihood of having depressive symptoms']","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",,0.0256045,"RESULTS
Hazardous drinking was significantly associated with increased likelihood of having depressive symptoms (aPR = 1.26;95%CI 1.04-1.52).","[{'ForeName': 'M X', 'Initials': 'MX', 'LastName': 'Nguyen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Epidemiology, Institute of Preventive Medicine and Public Health, Hanoi Medical University, Hanoi, Vietnam. Electronic address: binhminh@live.unc.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'Department of Epidemiology, College of Public Health, Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Q X', 'Initials': 'QX', 'LastName': 'Bui', 'Affiliation': 'UNC Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Tran', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; UNC Project Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'V F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108249']
1891,32842052,"Breast effects of oral, combined 17β-estradiol, and progesterone capsules in menopausal women: a randomized controlled trial.","OBJECTIVE
To evaluate the effect of a single-capsule, bioidentical 17β-estradiol (E2) and progesterone (P4) hormone therapy on mammograms and breasts in postmenopausal women after 1 year of use.
METHODS
In the 12-month, phase 3, randomized, double-blind, placebo-controlled, multicenter REPLENISH trial, postmenopausal women (40-65 y) with moderate to severe vasomotor symptoms and a uterus were randomized to four active daily dose groups of E2/P4 (TX-001HR) or a placebo group. Mammograms were performed and read locally at screening (or ≤6 months before first dose) and at study end using BI-RADS classification. Incidence of abnormal mammograms and breast adverse events was evaluated.
RESULTS
All but 8 (0.4%) mammograms at screening were normal (BI-RADS 1 or 2). At 1 year, 39 (2.9%) of the 1,340 study-end mammograms were abnormal (BI-RADS 3 or 4); incidence was 1.7% to3.7% with active doses and 3.1% with placebo. Breast cancer incidence was 0.36% with active doses and 0% with placebo. Breast tenderness was reported at frequencies of 2.4% to 10.8% with active doses versus 0.7% with placebo, and led to eight study discontinuations (1.6% of discontinuations in active groups).
CONCLUSIONS
In this phase 3 trial of a combined E2/P4, results of secondary outcomes suggest that E2/P4 may not be associated with increased risk of abnormal mammograms versus placebo, and the incidence of breast tenderness was low relative to most of the rates reported in other studies using hormone therapy.",2020,"At 1 year, 39 (2.9%) of the 1,340 study-end mammograms were abnormal (BI-RADS 3 or 4); incidence was 1.7% to3.7% with active doses and 3.1% with placebo.","['mammograms and breasts in postmenopausal women after 1 year of use', 'menopausal women', 'postmenopausal women (40-65 y) with moderate to severe vasomotor symptoms and a uterus']","['placebo', 'oral, combined 17β-estradiol, and progesterone capsules', 'single-capsule, bioidentical 17β-estradiol (E2) and progesterone (P4) hormone therapy', 'E2/P4 (TX-001HR']","['Incidence of abnormal mammograms and breast adverse events', 'Breast tenderness', 'Breast cancer incidence', 'risk of abnormal mammograms']","[{'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C4279222', 'cui_str': 'TX-001HR'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0262365', 'cui_str': 'Mammography abnormal'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0262397', 'cui_str': 'Breast tenderness'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.637879,"At 1 year, 39 (2.9%) of the 1,340 study-end mammograms were abnormal (BI-RADS 3 or 4); incidence was 1.7% to3.7% with active doses and 3.1% with placebo.","[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'University Hospitals Cleveland Medical Center, Cleveland, OH.'}, {'ForeName': 'Denise R', 'Initials': 'DR', 'LastName': 'Black', 'Affiliation': 'University of Manitoba, Winnipeg MB, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Larkin', 'Affiliation': 'Ms.Medicine, Cincinnati, OH.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001631']
1892,32844366,Feasibility of Imported Self-Management Program for Elderly People with Chronic Pain: A Single-Arm Confirmatory Trial.,"INTRODUCTION
Multidisciplinary pain management programs incorporating a cognitive-behavioral therapy (CBT) approach have been reported to be helpful for elderly people with chronic pain. However, it is unclear whether the same program for elderly people with chronic pain would translate to different cultures. This study investigated whether a multidisciplinary program based on that of Nicholas et al. (Pain 154(6):824-835, 2013) in Australia would be effective for elderly people with chronic pain in Japan.
METHODS
Twenty-seven community-dwelling elderly people with chronic pain were enrolled to confirm changes (effect size d = 0.5) in pain disability, which were previously reported by Nicholas et al. The multidisciplinary program consisted of eight sessions (2 sessions a week for 4 weeks). Pain disability was assessed using the Pain Disability Assessment Scale (PDAS) as the primary outcome at the baseline, the beginning and the end of the program, and the 1- and 3-month (final) follow-up. We also assessed the pain severity, catastrophizing, pain self-efficacy, and physical function with the Timed Up and Go test (TUG) and the two-step test as secondary outcomes.
RESULTS
PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up. The effect size (d) for the PDAS score was a medium size (0.54) from baseline to 3-month follow-up. Those who showed improvements in TUG immediately after the program tended to report improved psychometric measures at 3-month follow-up.
CONCLUSION
These results suggest that the Japanese multidisciplinary program has a similar effect on pain disability as that reported by Nicholas et al. This finding has important implications for the development of pain services in community-dwelling elderly Japanese.",2020,"RESULTS
PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up.","['Twenty-seven community-dwelling elderly people with chronic pain', 'elderly people with chronic pain in Japan', 'elderly people with chronic pain', 'community-dwelling elderly Japanese', 'Elderly People with Chronic Pain']","['cognitive-behavioral therapy (CBT) approach', 'Imported Self-Management Program']","['psychometric measures', 'Pain disability', 'pain severity, catastrophizing, pain self-efficacy, and physical function with the Timed Up and Go test (TUG', 'PDAS, pain catastrophizing, and pain self-efficacy', 'pain disability', 'Pain Disability Assessment Scale (PDAS']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}]",,0.0331891,"RESULTS
PDAS, pain catastrophizing, and pain self-efficacy were significantly improved immediately after the program compared with baseline, and these effects were maintained at 3-month follow-up.","[{'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Ikemoto', 'Affiliation': 'Department of Orthopaedics, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Shiro', 'Affiliation': 'Nagoya Gakuin University, Nagoya, Japan. shiro823@ngu.ac.jp.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Ikemoto', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Hayashi', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Young-Chang', 'Initials': 'YC', 'LastName': 'Arai', 'Affiliation': 'Research of Pain Science, Non-Profit Organization, Nagoya, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Deie', 'Affiliation': 'Department of Orthopaedics, Aichi Medical University, Aichi, Japan.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Beeston', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nicholas', 'Affiliation': 'Pain Management Research Institute, Faculty of Medicine and Health, University of Sydney and Royal North Shore Hospital, Sydney, NSW, Australia.'}]",Pain and therapy,['10.1007/s40122-020-00192-2']
1893,32844378,"A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Giant Cell Arteritis.","INTRODUCTION
To evaluate the efficacy and safety of sirukumab in giant cell arteritis (GCA).
METHODS
In this multicentre, randomised, double-blind, placebo-controlled, two-part phase 3 trial (NCT02531633; Part A [52-week double-blind treatment]; Part B [104-week follow-up]), patients with GCA were randomised (3:3:2:2:2) to sirukumab 100 mg every 2 weeks plus 6-month or 3-month prednisone taper, sirukumab 50 mg every 4 weeks plus 6-month prednisone taper, or placebo every 2 weeks plus 6-month or 12-month prednisone taper. The primary endpoint was the proportion of patients in sustained remission at week 52. Secondary endpoints included disease flare and safety. The study was terminated early (October 2017; sponsor decision).
RESULTS
Of 161 patients randomised (sirukumab: n = 107; placebo: n = 54), 28 (17.4%) completed week 52 (median treatment duration: 24-30 weeks). In a revised intent-to-treat (ITT) subgroup (completed week 52 or discontinued before study termination [n = 55]); six patients (all receiving sirukumab) achieved the primary endpoint. In the ITT population (n = 161), the proportion of patients with flares (week 2-52) was lower with sirukumab (18.4-30.8%) than placebo (37.0-40.0%). The proportion of patients with flares (week 2-12) was highest with sirukumab 100 mg every 2 weeks plus 3-month prednisone taper (23.1%). In Part A, 94.4% of patients reported ≥ 1 treatment-emergent adverse event (TEAE); 19.3% reported serious TEAEs. The proportions of patients with TEAEs were generally similar across treatment arms. No deaths occurred.
CONCLUSIONS
Although data were limited due to early termination and shortened treatment duration, sirukumab treatment resulted in numerically lower proportions of patients with flare by week 52 versus placebo, with no unexpected safety findings.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT02531633.",2020,"No deaths occurred.
","['patients with GCA', 'Giant Cell Arteritis', '161 patients randomised (sirukumab: n\u2009=\u2009107']","[' placebo', 'prednisone taper, or placebo', 'prednisone taper', 'placebo', 'Sirukumab', 'Placebo', 'sirukumab 100\xa0mg every 2\xa0weeks plus 6-month or 3-month prednisone taper, sirukumab 50\xa0mg']","['efficacy and safety', 'Efficacy and Safety', 'proportion of patients with flares', 'proportion of patients in sustained remission', 'disease flare and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039483', 'cui_str': 'Giant cell arteritis'}, {'cui': 'C3254570', 'cui_str': 'sirukumab'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C3254570', 'cui_str': 'sirukumab'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.382909,"No deaths occurred.
","[{'ForeName': 'Wolfgang A', 'Initials': 'WA', 'LastName': 'Schmidt', 'Affiliation': 'Medical Center for Rheumatology, Immanuel Krankenhaus Berlin (Buch), Berlin, Germany.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Dasgupta', 'Affiliation': 'Rheumatology, Southend University Hospital NHS Foundation Trust, Essex, UK.'}, {'ForeName': 'Raashid', 'Initials': 'R', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Unizony', 'Affiliation': 'Rheumatology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Blockmans', 'Affiliation': 'Department of General Internal Medicine, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Lai', 'Affiliation': 'Immunoinflammation, GlaxoSmithKline, Collegeville, PA, USA. zhihong.v.lai@gsk.com.'}, {'ForeName': 'Regina H', 'Initials': 'RH', 'LastName': 'Kurrasch', 'Affiliation': 'Immunoinflammation, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Lazic', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Brown', 'Affiliation': 'Immunoinflammation, GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': 'Immunology and Specialty Medicine, GlaxoSmithKline, Stevenage, Hertfordshire, UK.'}]",Rheumatology and therapy,['10.1007/s40744-020-00227-2']
1894,32843306,Embryo Ranking Intelligent Classification Algorithm (ERICA): artificial intelligence clinical assistant predicting embryo ploidy and implantation.,"RESEARCH QUESTION
Can a deep machine learning artificial intelligence algorithm predict ploidy and implantation in a known data set of static blastocyst images, and how does its performance compare against chance and experienced embryologists?
DESIGN
A database of blastocyst images with known outcome was applied with an algorithm dubbed ERICA (Embryo Ranking Intelligent Classification Algorithm). It was evaluated against its ability to predict euploidy, compare ploidy prediction against randomly assigned prognosis labels and against senior embryologists, and if it could rank an euploid embryo highly.
RESULTS
A total of 1231 embryo images were classed as good prognosis if euploid and implanted or poor prognosis if aneuploid and failed to implant. An accuracy of 0.70 was obtained with ERICA, with positive predictive value of 0.79 for predicting euploidy. ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively). ERICA ranked an euploid blastocyst first in 78.9% and at least one euploid embryo within the top two blastocysts in 94.7% of cases, better than random classification and the two senior embryologists. Average embryo ranking time for four blastocysts was under 25 s.
CONCLUSION
Artificial intelligence lends itself well to image pattern recognition. We have trained ERICA to rank embryos based on ploidy and implantation potential using single static embryo image. This tool represents a potentially significant advantage to assist embryologists to choose the best embryo, saving time spent annotating and does not require time lapse or invasive biopsy. Future work should be directed to evaluate reproducibility in different data sets.",2020,"ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively).",[],[],['Average embryo ranking time'],[],[],"[{'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",1231.0,0.0681082,"ERICA had greater normalized discontinued cumulative gain (ranking metric) than random selection (P = 0.0007), and both embryologists (P = 0.0014 and 0.0242, respectively).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Chavez-Badiola', 'Affiliation': 'New Hope Fertility Center Mexico. Av. Prado Norte 135, Lomas de Chapultepec, Miguel Hidalgo, Mexico City, Mexico CP 11000; IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK. Electronic address: acb@EmbryoRanking.com.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Flores-Saiffe-Farías', 'Affiliation': 'New Hope Fertility Center Mexico. Av. Prado Norte 135, Lomas de Chapultepec, Miguel Hidalgo, Mexico City, Mexico CP 11000; IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Mendizabal-Ruiz', 'Affiliation': 'Department of Computational Sciences, Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Drakeley', 'Affiliation': ""IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK; Hewitt Fertility Centre, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'IVF 2.0 LTD, 1 Liverpool Road, Maghull, Merseyside, UK; ART Institute of Washington, Bethesda Maryland, USA; IVFqc, 1185 Sixth Avenue, New York New York, USA.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.07.003']
1895,32854975,"Corrigendum to ""Metabolic linkages between indoor negative air ions, particulate matter and cardiorespiratory function: A randomized, double-blind crossover study among children"" [Environ. Int. 138 (2020) 105663].",,2020,,"['children"" [Environ']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],,0.203812,,"[{'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Qingyu', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Institute of Child and Adolescent Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Mengtian', 'Initials': 'M', 'LastName': 'Chu', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Building Science, School of Architecture, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Heqing', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Key Laboratory of Urban Environment and Health, Institute of Urban Environment, Chinese Academy of Sciences, Xiamen 361021, China; State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Public Health, Xiamen University, Xiamen 361102, China.'}, {'ForeName': 'Xinbiao', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Furong', 'Initials': 'F', 'LastName': 'Deng', 'Affiliation': 'Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.'}]",Environment international,['10.1016/j.envint.2020.106073']
1896,32858228,DO-HEALTH: Vitamin D3 - Omega-3 - Home exercise - Healthy aging and longevity trial - Design of a multinational clinical trial on healthy aging among European seniors.,"DO-HEALTH is a multi-center clinical trial among 2157 community-dwelling European men and women age 70 and older. The 2x2x2 randomized-control factorial design trial tested the individual and additive benefit, as well as the cost-effectiveness, of 3 interventions: vitamin D 2000 IU/day, omega-3 fatty acids 1000 mg/day (EPA + DHA, ratio 1:2), and a 30-minute 3 times/week home exercise (strength versus flexibility). Each treatment tested has shown considerable prior promise from mechanistic studies, small clinical trials, or large cohort studies, in the prevention of common age-related chronic diseases, but definitive data are missing. DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty). As the 3 interventions have distinct mechanisms of action for each of the 6 primary endpoints, a maximum benefit is expected for their additive benefit as a ""multi-modal"" intervention. The trial duration is 3 years with in-person contacts with all participants at 4 clinical visits and by quarterly phone calls. Baseline and follow-up blood samples were collected in all participants to measure changes in 25-hydroxyvitamin D and poly-unsaturated fatty acid concentrations. Our objective was to test interventions that are expected to promote healthy aging and longer life expectancy and that can be easily and safely implemented by older community-dwelling adults.",2020,"DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty).","['healthy aging among European seniors', 'older community-dwelling adults', '3\u202fyears with in-person contacts with all participants at 4 clinical visits and by quarterly phone calls', '2157 community-dwelling European men and women age 70 and older']","['3 interventions: vitamin D 2000\u202fIU/day, omega-3 fatty acids 1000']","['falls and injurious falls, joint pain, oral health, quality of life, and incident frailty', 'systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections', '25-hydroxyvitamin D and poly-unsaturated fatty acid concentrations']","[{'cui': 'C2963171', 'cui_str': 'Healthy Ageing'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",2157.0,0.100229,"DO-HEALTH will test these interventions in relation to 6 primary endpoints (systolic and diastolic blood pressure, non-vertebral fractures, Short Physical Performance Battery score, the Montreal Cognitive Assessment, and risk of infections), plus several secondary endpoints explored in ancillary studies (i.e. rate of any falls and injurious falls, joint pain, oral health, quality of life, and incident frailty).","[{'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland; Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland; University Clinic for Acute Geriatric Care, City Hospital Waid&Triemli, Zurich, Switzerland. Electronic address: Heike.Bischoff@usz.ch.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'de Godoi Rezende Costa Molino', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Rival', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Center Hospitalo-Universitaire de Toulouse, Toulouse, France; UMR INSERM 1027, University of Toulouse III, Toulouse, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Rizzoli', 'Affiliation': 'Division of Bone Diseases, Geneva University Hospitals, Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Reto W', 'Initials': 'RW', 'LastName': 'Kressig', 'Affiliation': 'University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Centre for Metabolic Bone Diseases, University of Sheffield Medical School, United Kingdom; Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, Victoria, Australia.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA, USA.'}, {'ForeName': 'Endel J', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'José A P', 'Initials': 'JAP', 'LastName': 'da Silva', 'Affiliation': 'Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blauth', 'Affiliation': 'Department for Trauma Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Felsenberg', 'Affiliation': 'Center for Muscle and Bone Research, Department of Radiology, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ferrari', 'Affiliation': 'Ferrari Data Solutions, Feldmeilen, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland; Department of Geriatric Medicine and Aging Research, University Hospital Zurich and University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Center on Aging and Mobility, University Hospital Zurich, City HospitalWaid & Triemli and University of Zurich, Zurich, Switzerland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106124']
1897,32858239,Polyvalent Mechanical Bacterial Lysate Administration Improves the Clinical Course of Grass Pollen-Induced Allergic Rhinitis in Children: A Randomized Controlled Trial.,"BACKGROUND
Recent studies highlight the immunoregulatory potential of bacterial lysates, indicating their potential use in the prevention and treatment of allergic diseases.
OBJECTIVE
To investigate the clinical efficacy of polyvalent mechanical bacterial lysates (PMBLs) in children with grass pollen-induced allergic rhinitis.
METHODS
Seventy children with seasonal allergic rhinitis were enrolled to this study and were randomly assigned to the PMBL and placebo groups. Severity of seasonal allergic rhinitis symptoms was assessed by the total nasal symptom score, total ocular symptom score, and visual analogue scale. During 3 visits, peak nasal inspiratory flow was measured, and nasal smears for the presence of eosinophils and nasal lavage fluids for the presence of allergen-specific IgE against timothy grass pollen allergens were sampled.
RESULTS
A statistically significant decrease in total nasal symptom score (P = .001), total ocular symptom score (P = .04), and visual analogue scale score for nasal and eye symptoms (P < .001 and P < .001, respectively) and an increase in peak nasal inspiratory flow (P = .04) were observed in the PMBL group versus the placebo group. During the grass pollen season, an increase and then a decrease in the number of eosinophils in nasal smears was observed in both groups; however, the number of eosinophils was significantly lower in the PMBL group versus the placebo group. No significant changes in allergen-specific IgE concentrations were observed in the PMBL group, whereas in the placebo group a statistically significant increase in allergen-specific IgE concentration was observed.
CONCLUSIONS
Sublingual administration of PMBLs during the grass pollen season offers significant efficacy in alleviating seasonal allergic rhinitis symptoms in children sensitized to grass pollen allergens. PMBLs probably affect mucosal immunity, weakening the response of T H 2 cells.",2020,"RESULTS
A statistically significant decrease of TNSS (p=0.001), TOSS (p=0.04), VAS for nasal and eye symptoms (p<0.001, p<0.001, respectively) and increase of PNIF (p=0.04) were observed in the PMBL group vs. placebo group.","['children sensitized to grass pollen allergens', 'grass pollen-induced allergic rhinitis in children', 'children with grass pollen-induced allergic rhinitis', 'Seventy children with seasonal allergic rhinitis (SAR']","['PMBL', 'Polyvalent mechanical bacterial lysate administration', 'polyvalent mechanical bacterial lysates (PMBL', 'placebo', 'PMBL and placebo']","['number of eosinophils in nasal smears', 'peak nasal inspiratory flow (PNIF', 'Severity of SAR symptoms', 'asIgE concentration', 'number of eosinophils', 'TOSS', 'TNSS', 'SAR symptoms', 'asIgE concentrations', 'total nasal symptom score (TNSS), total ocular symptom score (TOSS) and visual analogue scale (VAS', 'PNIF', 'VAS for nasal and eye symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444971', 'cui_str': 'Grass pollen allergen'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}]","[{'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018621', 'cui_str': 'Seasonal allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}]",70.0,0.280302,"RESULTS
A statistically significant decrease of TNSS (p=0.001), TOSS (p=0.04), VAS for nasal and eye symptoms (p<0.001, p<0.001, respectively) and increase of PNIF (p=0.04) were observed in the PMBL group vs. placebo group.","[{'ForeName': 'Kamil', 'Initials': 'K', 'LastName': 'Janeczek', 'Affiliation': 'Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland. Electronic address: kamil.janeczek@umlub.pl.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Emeryk', 'Affiliation': 'Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rachel', 'Affiliation': 'Chair and Department of Human Physiology and Pathophysiology, University of Rzeszów, Rzeszów, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Duma', 'Affiliation': 'Department of Laboratory Diagnostics, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Zimmer', 'Affiliation': 'Department of Applied and Social Pharmacy, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Poleszak', 'Affiliation': 'Department of Applied and Social Pharmacy, Medical University of Lublin, Lublin, Poland.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.08.025']
1898,32859615,Effect of Exercise or Metformin on Biomarkers of Inflammation in Breast and Colorectal Cancer: A Randomized Trial.,"Observational studies report that physical activity and metformin are associated with improved clinical outcome in patients with cancer. Inflammation is one biological mechanism hypothesized to mediate these associations. In this phase II, multicenter, 2 × 2 factorial trial, 139 patients with breast and colorectal cancer who completed standard therapy were randomized to one of four treatment groups for 12 weeks: exercise alone, metformin alone, exercise and metformin, or control. Inflammation outcomes included high-sensitivity C-reactive protein (hs-CRP), soluble tumor necrosis factor alpha receptor two (sTNFαR2), and IL6. The primary modeling strategy evaluated the trial product estimand that was quantified using a generalized linear mixed model. Compared with control, exercise alone reduced hs-CRP [-30.2%; 95% confidence interval (CI), -50.3, -1.0] and IL6 (-30.9%; 95% CI, -47.3, -9.5) but did not change sTNFαR2 (1.0%; 95% CI, -10.4, 13.9). Compared with control, metformin alone did not change hs-CRP (-13.9%; 95% CI, -40.0, 23.4), sTNFαR2 (-10.4%; 95% CI, -21.3, 2.0), or IL6 (-22.9%; 95% CI, -42.3, 2.0). Compared with control, exercise and metformin reduced sTNFαR2 (-13.1%; 95% CI, -22.9, -1.0) and IL6 (-38.7%; 95% CI, -52.3, -18.9) but did not change hs-CRP (-20.5%; 95% CI, -44.0, 12.7). The combination of exercise and metformin was not synergistic for hs-CRP, sTNFαR2, or IL6. In survivors of breast and colorectal cancer with low baseline physical activity and without type 2 diabetes, exercise and metformin reduced measures of inflammation that are associated with cancer recurrence and mortality.",2020,"Compared with control, exercise alone reduced hs-CRP: -30.2% (95% CI: -50.3, -1.0) and IL-6: -30.9% (95% CI: -47.3, -9.5); but did not change sTNF-αR2: 1.0% (95% CI: -10.4, 13.9).","['Breast and Colorectal Cancer', '139 patients with breast and colorectal cancer who completed standard therapy', 'patients with cancer']","['Exercise or Metformin', 'exercise alone, metformin alone, exercise and metformin, or control', 'metformin', 'exercise and metformin']","['high sensitivity C-reactive protein (hs-CRP), soluble tumor necrosis factor alpha receptor two (sTNF-αR2), and interleukin 6 (IL-6', 'change hs-CRP', 'cancer recurrence and mortality', 'sTNF-αR2']","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1453722', 'cui_str': 'TNFRSF1A protein, human'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",139.0,0.146342,"Compared with control, exercise alone reduced hs-CRP: -30.2% (95% CI: -50.3, -1.0) and IL-6: -30.9% (95% CI: -47.3, -9.5); but did not change sTNF-αR2: 1.0% (95% CI: -10.4, 13.9).","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana. justin.brown@pbrc.edu.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Melinda L', 'Initials': 'ML', 'LastName': 'Irwin', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Lee W', 'Initials': 'LW', 'LastName': 'Jones', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Campbell', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Pollak', 'Affiliation': 'McGill University, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Sorrentino', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Cartmel', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Harrigan', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Abrams', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sanft', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Harvard School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0188']
1899,32861841,Longitudinal trajectories of mood symptoms and global functioning in youth at high risk for bipolar disorder.,"BACKGROUND
Little is known about the longitudinal course of mood symptoms and functioning in youth who are at high risk for bipolar disorder (BD). Identifying distinct course trajectories and predictors of those trajectories may help refine treatment approaches.
METHODS
This study examined the longitudinal course of mood symptoms and functioning ratings in 126 youth at high risk for BD based on family history and early mood symptoms. Participants were enrolled in a randomized trial of family-focused therapy and followed longitudinally (mean 2.0 years, SD = 53.6 weeks).
RESULTS
Using latent class growth analyses (LCGA), we observed three mood trajectories. All youth started the study with active mood symptoms. Following the index mood episode, participants were classified as having a ""significantly improving course"" (n = 41, 32.5% of sample), a ""moderately symptomatic course"" (n = 21, 16.7%), or a ""predominantly symptomatic course"" (n = 64, 50.8%) at follow-up. More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness. LCGA also revealed three trajectories of global functioning that closely corresponded to symptom trajectories; however, fewer youth exhibited functional recovery than exhibited symptomatic recovery.
LIMITATIONS
Mood trajectories were assessed within the context of a treatment trial. Ratings of mood and functioning were based on retrospective recall.
CONCLUSIONS
This study suggests considerable heterogeneity in the course trajectories of youth at high risk for BD, with a significant proportion (32.5%) showing long-term remission of symptoms. Treatments that enhance psychosocial functioning may be just as important as those that ameliorate symptoms in youth at risk for BD.",2020,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","['126 youth at high risk for BD based on family history and early mood symptoms', 'youth at high risk for bipolar disorder', 'youth who are at high risk for bipolar disorder (BD']",['LCGA'],"['severe depression, anxiety, and suicidality']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0524716,"More severe depression, anxiety, and suicidality at the study's baseline were associated with a poorer course of illness.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Weintraub', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA. Electronic address: mjweintraub@mednet.ucla.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Schneck', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Patricia D', 'Initials': 'PD', 'LastName': 'Walshaw', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}, {'ForeName': 'Kiki D', 'Initials': 'KD', 'LastName': 'Chang', 'Affiliation': 'Private Practice, Menlo Park, CA, USA.'}, {'ForeName': 'Aimee E', 'Initials': 'AE', 'LastName': 'Sullivan', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Manpreet K', 'Initials': 'MK', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Miklowitz', 'Affiliation': 'Semel Institute of Neuroscience and Human Behavior, University of California, 760 Westwood Plaza, A7-370, Los Angeles 90095, CA, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.08.018']
1900,32864755,Online imagery rescripting among young women at risk of developing an eating disorder: A randomized controlled trial.,"OBJECTIVE
This study compared the effectiveness of two approaches to imagery rescripting (body versus general) among young women with an elevated risk of developing an eating disorder.
METHOD
University students (N = 130 females) were randomly assigned to one of the four conditions: body or general imagery rescripting, psychoeducation, control. After initial brief laboratory training delivered online, participants in the imagery rescripting conditions were asked to practice imagery rescripting for 5 min each day for a week. Primary (global eating psychopathology, eating disorder behaviors, and body image acceptance) and secondary outcomes (self-compassion, fear of self-compassion, and dysfunctional attitudes) were measured at baseline and one-week follow up.
RESULTS
Completer analyses showed both imagery rescripting conditions and psychoeducation had significant impact on global eating psychopathology and body acceptance (d = 0.60-0.78). Psychoeducation did not impact secondary variables, whereas body imagery rescripting improved self-compassion and fear of self-compassion (d = 0.61-0.80) and general imagery rescripting improved dysfunctional attitudes (d = 0.82) compared to control. Intent to treat analyses had similar but slightly less robust results.
DISCUSSION
While three active groups had significant impact on the primary variables, imagery rescripting approaches had impact on other variables that maintain disordered eating. Future research should investigate the impact of combining psychoeducation and imagery rescripting in terms of impact on disordered eating.",2020,Completer analyses showed both imagery rescripting conditions and psychoeducation had significant impact on global eating psychopathology and body acceptance (d = 0.60-0.78).,"['University students (N = 130 females', 'young women with an elevated risk of developing an eating disorder', 'young women at risk of developing an eating disorder']","['imagery rescripting (body versus general', 'body or general imagery rescripting, psychoeducation, control']","['global eating psychopathology and body acceptance', 'dysfunctional attitudes', 'self-compassion and fear of self-compassion', 'Primary (global eating psychopathology, eating disorder behaviors, and body image acceptance) and secondary outcomes (self-compassion, fear of self-compassion, and dysfunctional attitudes']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",130.0,0.0837767,Completer analyses showed both imagery rescripting conditions and psychoeducation had significant impact on global eating psychopathology and body acceptance (d = 0.60-0.78).,"[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'College of Education Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jamie-Lee', 'Initials': 'JL', 'LastName': 'Pennesi', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Tracey D', 'Initials': 'TD', 'LastName': 'Wade', 'Affiliation': 'College of Education Psychology & Social Work, Flinders University, Adelaide, South Australia, Australia.'}]",The International journal of eating disorders,['10.1002/eat.23370']
1901,32876903,Efficacy and Safety of Baricitinib in Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses: Results from Study RA-BALANCE.,"INTRODUCTION
Baricitinib is an oral selective inhibitor of Janus kinase (JAK) 1 and JAK 2, which has demonstrated significant efficacy in patients with moderately to severely active rheumatoid arthritis (RA). This analysis aims to describe the efficacy and safety of baricitinib in Chinese RA patients with an inadequate response to methotrexate (MTX-IR), and to analyze the effects of baseline characteristics on the efficacy of baricitinib treatment.
METHODS
In this 52-week, randomized, double-blind, placebo-controlled study, 231 Chinese patients with moderately to severely active RA who had MTX-IR were randomly assigned to placebo (n = 115) or baricitinib 4 mg once daily (n = 116). The primary endpoint was American College of Rheumatology 20% (ACR20) response at week 12. Other efficacy measures included ACR50, ACR70, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, patient's assessment of pain, Disease Activity Score in 28 joints using high-sensitivity C-reactive protein, remission and low disease activity rates according to Simplified Disease Activity Index or Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, and mean duration and severity of morning joint stiffness, worst tiredness and worst joint pain were analyzed. Additionally, subgroup analyses were performed across baseline characteristics.
RESULTS
Statistically significant improvement in ACR20 response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo. Most of the secondary objectives were met with statistically significant improvements. Efficacy of baricitinib was irrespective of patient demographics and baseline characteristics. Safety events were similar between the baricitinib and placebo groups.
CONCLUSIONS
The efficacy of baricitinib 4 mg in Chinese patients with moderately to severely active RA and prior MTX-IR was clinically significant compared to placebo regardless of baseline characteristics. Baricitinib was well tolerated with an acceptable safety profile during the full study period.
TRIAL REGISTRATION
NCT02265705.",2020,"Statistically significant improvement in ACR20 response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo.","['Chinese patients with moderately to severely active RA and prior MTX-IR', 'patients with moderately to severely active rheumatoid arthritis (RA', '231 Chinese patients with moderately to severely active RA who had MTX-IR', 'Chinese Rheumatoid Arthritis Patients and the Subgroup Analyses', 'Chinese RA patients with an inadequate response to']","['baricitinib 4\xa0mg once daily', 'methotrexate (MTX-IR', 'placebo', 'Baricitinib']","['Efficacy and Safety', 'American College of Rheumatology 20% (ACR20) response', 'ACR20 response', ""ACR50, ACR70, Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, patient's assessment of pain, Disease Activity Score in 28 joints using high-sensitivity C-reactive protein, remission and low disease activity rates according to Simplified Disease Activity Index or Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, and mean duration and severity of morning joint stiffness, worst tiredness and worst joint pain"", 'efficacy and safety of baricitinib', 'Safety events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0162298', 'cui_str': 'Joint stiffness'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",231.0,0.422454,"Statistically significant improvement in ACR20 response was achieved with baricitinib at week 12 (53.4 vs. 22.6%, p = 0.001) in Chinese patients, compared to placebo.","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Xing-Fu', 'Initials': 'XF', 'LastName': 'Li', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Chun-De', 'Initials': 'CD', 'LastName': 'Bao', 'Affiliation': 'Renji Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jian-Kang', 'Initials': 'JK', 'LastName': 'Hu', 'Affiliation': ""Jiangxi Pingxiang People's Hospital, Pingxiang, China.""}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Xiang-Pei', 'Initials': 'XP', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Dong-Yi', 'Initials': 'DY', 'LastName': 'He', 'Affiliation': 'GuangHua Hospital, Shanghai, China.'}, {'ForeName': 'Zhi-Jun', 'Initials': 'ZJ', 'LastName': 'Li', 'Affiliation': 'First Affiliated Hospital of Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Guo-Chun', 'Initials': 'GC', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Han-Jun', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Lu-Jing', 'Initials': 'LJ', 'LastName': 'Zhan', 'Affiliation': 'Eli Lilly and Company, Shanghai, China.'}, {'ForeName': 'Cristiano A F', 'Initials': 'CAF', 'LastName': 'Zerbini', 'Affiliation': 'CEPIC-Centro Paulista de Investigação Clinica E Serviços Medicos, Ipiranga, São Paulo, Brazil.'}, {'ForeName': 'Zhan-Guo', 'Initials': 'ZG', 'LastName': 'Li', 'Affiliation': ""Peking University People's Hospital, Beijing, China. zhanguo_li@hotmail.com.""}]",Rheumatology and therapy,['10.1007/s40744-020-00231-6']
1902,32871454,Difficulties in developmental follow-up of preterm neonates in a randomised-controlled trial of Bifidobacterium breve M16-V - Experience from Western Australia.,"BACKGROUND
Probiotics may be neuroprotective for preterm neonates due to their anti-inflammatory effects and ability to facilitate nutrition.
AIM
To assess long-term effects of early probiotic supplementation on neuropsychological development in preterm infants.
STUDY DESIGN
Follow up study.
SUBJECTS
Children at age 3 to 5 years who had participated as preterm infants (<33 week) in the randomised controlled trial.
OUTCOMES
Primary: Continuous early learning composite measure derived from the Mullen's Scale of Early Learning (MSEL). Other outcomes were assessed by the Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition.
MEASURES
Continuous scores derived from all the measures.
RESULTS
67 children of the 159 participants (42%) (Probiotic: 36/79, Placebo: 31/80) were followed-up for at least one neuropsychological assessment. All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children. Multivariable analysis of MSEL composite score showed no evidence of probiotic effect univariately, or after adjustment for gestation, intrauterine growth restriction, Apgar <7 at 5 min and age at assessment (adjusted mean effect in probiotic group: -2.7, 95% CI -8.5-3.0, p = 0.349).
CONCLUSION
There was no significant effect on neurodevelopment of children assessed at the age of 3 to 5 years who participated as preterm neonates in the RCT of B. breve M-16V. The validity of these results is limited by the reduced sample size due to high rate of loss to follow up.",2020,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"['preterm infants', 'Children at age 3 to 5\xa0years who had participated as preterm infants (<33\xa0week', 'preterm neonates', '67 children of the 159 participants (42', 'from Western Australia']","['early probiotic supplementation', 'Placebo', 'Bifidobacterium breve M16-V - Experience', 'M-16V']","[""Developmental, Dimensional and Diagnostic Interview, Developmental NEuroPSYchological assessment-2nd Edition, Parental questionnaires using children's communication checklist-2nd edition, social responsiveness scale, and Vineland Adaptive Behavioural Scales-2nd edition"", ""Mullen's Scale of Early Learning (MSEL""]","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0314975', 'cui_str': 'Bifidobacterium breve'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C3875061', 'cui_str': 'Developmental, dimensional and diagnostic interview'}, {'cui': 'C2987126', 'cui_str': 'NEPSY'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",159.0,0.215666,All six assessments were completed in 18/31 (58.1%) of the control vs. 11/36 (30.6%) probiotic group children.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia. Electronic address: sachin.agrawal@health.wa.gov.au.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Pestell', 'Affiliation': 'School of Psychological Science, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Granich', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Neonatal Pediatrics, Perth Children Hospital, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nathan', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Women and Infants Research Foundation, King Edward Memorial Hospital for Women, 374, Bagot Road, Subiaco, Perth, WA, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wray', 'Affiliation': 'School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia; Child Development Centre, 4/16 Rheola St, West Perth, WA 6005, Australia.'}, {'ForeName': 'A J O', 'Initials': 'AJO', 'LastName': 'Whitehouse', 'Affiliation': 'Telethon Kids Institute, 15 Hospital Avenue, Nedlands, WA, 6009 Perth, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Patole', 'Affiliation': 'Neonatal Directorate, KEM Hospital for Women, 374 Bagot Road, Subiaco, WA, Australia; School of Medicine, University of WA, 35 Stirling Highway, Crawley, WA, 6009 Perth, Australia.'}]",Early human development,['10.1016/j.earlhumdev.2020.105165']
1903,32871029,"High-dose dexamethasone plus recombinant human thrombopoietin vs high-dose dexamethasone alone as frontline treatment for newly diagnosed adult primary immune thrombocytopenia: A prospective, multicenter, randomized trial.","We conducted a prospective, multicenter, randomized, controlled clinical trial to compare the efficacy and safety of high-dose dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO), vs HD-DXM alone in newly diagnosed adult immune thrombocytopenia (ITP) patients. Enrolled patients were randomly assigned to receive DXM plus rhTPO or DXM monotherapy. Another 4-day course of DXM was repeated if response was not achieved by day 10 in both arms. One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set. So, HD-DXM plus rhTPO resulted in a higher incidence of initial response (89.0% vs 66.7%, P < .001) and complete response (CR, 75.0% vs 42.7%, P < .001) compared with HD-DXM monotherapy. Response rate at 6 months was also higher in the HD-DXM plus rhTPO arm than that in the HD-DXM monotherapy arm (51.0% vs 36.5%, P = .02; sustained CR: 46.0% vs 32.3%, P = .043). Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = .04), as estimated by the Kaplan-Meier analysis. The study drugs were generally well tolerated. In conclusion, the combination of HD-DXM with rhTPO significantly improved the initial response and yielded favorable SR in newly diagnosed ITP patients, thus could be further validated as a frontline treatment for ITP. This study is registered as clinicaltrials.gov identifier: NCT01734044.",2020,"Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis.","['newly diagnosed adult immune thrombocytopenia (ITP) patients', 'One hundred patients in the HD-DXM plus rhTPO arm and 96 patients in the HD-DXM monotherapy arm were included in the full analysis set', 'newly diagnosed adult primary immune thrombocytopenia', 'newly diagnosed ITP patients']","['dexamethasone (HD-DXM) plus recombinant human thrombopoietin (rhTPO) versus HD-DXM alone', 'DXM', 'DXM plus rhTPO or DXM monotherapy', 'dexamethasone', 'dexamethasone plus recombinant human thrombopoietin']","['initial response and yielded favorable SR', 'Response rate', 'efficacy and safety', 'initial response', 'overall duration of response', 'tolerated', 'complete response']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",,0.108466,"Throughout the follow-up period, the overall duration of response was greater in the HD-DXM plus rhTPO arm compared to the HD-DXM monotherapy arm (P = 0.04), as estimated by the Kaplan-Meier analysis.","[{'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, The Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Qin', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Qingshu', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Wenzheng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Hematology, Binzhou Medical University Hospital, Binzhou, China.'}, {'ForeName': 'Xinhong', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Hematology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Jingxia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Hematology, Xinjiang Uiger Municipal People's Hospital, Urumqi, China.""}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Shengli Oilfield Central Hospital, Dongying, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chu', 'Affiliation': 'Department of Hematology, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of Hematology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Hematology, The Second Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Military General Hospital, Jinan, China.'}, {'ForeName': 'Zhaogang', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Hematology, Taian City Central Hospital, Taian, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, China.'}, {'ForeName': 'Zhencheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Zibo Central Hospital, Zibo, China.'}, {'ForeName': 'Xuehong', 'Initials': 'X', 'LastName': 'Ran', 'Affiliation': ""Department of Hematology, Weifang People's Hospital, Weifang, China.""}, {'ForeName': 'Hongguo', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Hematology, Linyi People's Hospital, Linyi, China.""}, {'ForeName': 'Kehong', 'Initials': 'K', 'LastName': 'Bi', 'Affiliation': 'Department of Hematology, Shandong Provincial Qianfoshan Hospital, Jinan, China.'}, {'ForeName': 'Daqi', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Hematology, Jinan Central Hospital, Jinan, China.'}, {'ForeName': 'Chenglu', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Hematology, Qilu Hospital (Qingdao), Shandong University, Qingdao, China.'}, {'ForeName': 'Ruirong', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Hematology, Shandong Provincial Hospital of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Yili', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Weihai Municipal Hospital, Weihai, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Zhejiang Provincial Hospital of TCM, Hangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xin-Guang', 'Initials': 'XG', 'LastName': 'Liu', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}]",American journal of hematology,['10.1002/ajh.25989']
1904,32898517,Cardiac autonomic and blood pressure responses to an acute session of battling ropes exercise.,"BACKGROUND
Battling rope (BTR) exercise has become incredibly popular among not only fitness enthusiasts and athletes but in the general exercising population. Despite its popularity, research regarding the acute cardiovascular responses to BTR exercise is limited. This investigation evaluated the effects of acute BTR exercise on heart rate variability (HRV) and blood pressure (BP) responses in young men with elevated BP.
MATERIALS AND METHODS
Eleven young men with elevated BP completed either a BTR or a non-exercise control trial in randomized order. The BTR trial consisted of 10 rounds of BTR exercise. Each round included 30 s of exercise followed by 30 s of rest. HRV and BP were evaluated at baseline and 3, 10, and 30 min following each trial.
RESULTS
There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 min following the BTR trial, whereas no changes from baseline were detected after control. Additionally, there were significant reductions (p ˂0.01) in markers of vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations) for 30 min; as well as (p ˂0.01) systolic BP and diastolic BP at 10 and 30 min after the BTR, but not the control trial.
CONCLUSION
Current findings revealed that BTR exercise elevates sympathovagal balance for 30 min post-intervention, which is concurrent with an impressive hypotensive effect. Further investigations are warranted to assess the potential clinical application of BTR exercise not only in cohorts needing BP control but also in populations with limited locomotion that might benefit from post-exercise hypotension.",2020,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","['young men with elevated BP', 'Eleven young men with elevated BP completed either a']","['Battling rope (BTR) exercise', 'BTR or a non-exercise control', 'acute BTR exercise', 'BTR exercise']","['systolic BP and diastolic BP', 'sympathovagal balance', 'heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF', 'Cardiac Autonomic and Blood Pressure Responses', 'HRV and BP', 'heart rate variability (HRV) and blood pressure (BP) responses', 'vagal tone (RMSSD, LnHF and nHF) and LnLF (both sympathetic and vagal modulations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",11.0,0.10577,"There were significant elevations (p ˂0.01) in heart rate, markers of sympathetic activity (nLF), and sympathovagal balance (LnLF/LnHF, nLF/nHF) for 30 minutes following the BTR trial, whereas no changes from baseline were detected after control.","[{'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States. Electronic address: awong@marymount.edu.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Bergen', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nordvall', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Allnutt', 'Affiliation': 'Department of Health and Human Performance, Marymount University, 2807 North Glebe Road, Arlington, VA 22207, United States.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113167']
1905,32898578,Family Integrated Care for Preterm Infants in China: A Cluster Randomized Controlled Trial.,"OBJECTIVE
To explore whether family integrated care (FICare) is feasible and improves the outcomes of preterm infants in China.
STUDY DESIGN
This was a multicenter prospective cluster-randomized controlled trial comparing FICare and standard care. The primary outcome was length of stay (LOS). Secondary outcomes were nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight gain. Outcomes were compared using univariate and multivariable analyses adjusted for potential confounders and clustering.
RESULTS
We enrolled 601 preterm infants from 11 neonatal intensive care units (FICare, n = 298; control, n = 303). The unadjusted LOS was 30.81 vs 30.26 days (mean ratio, 1.02; 95% CI, 0.85-1.22; P = .85). After adjustment, outcomes in the FICare group were improved compared with the control group, including LOS (28.26 vs 35.04 days; mean ratio, 0.81; 95% CI, 0.72-0.91), total medical expenditures (mean ratio, 0.69; 95% CI, 0.53-0.90), weight gain velocity (15.73 vs 10.30 g/day; mean difference, 5.43; 95% CI, 3.65-7.21), duration of supplemental oxygen (13.11 vs 21.42 days; mean difference, 0.71; 95% CI, 0.50-1.00), nosocomial infection rates (4.13 vs 5.84/1000 hospital days; mean ratio, 0.67; 95% CI, 0.47-0.96), antibiotic exposure (38.63 vs 57.32/100 hospital days; mean ratio, 0.67; 95% CI, 0.47-0.96), breastfeeding rates (87.25% vs 55.78%; OR, 5.42; 95% CI, 3.25-9.05), and rehospitalization rates (3.65% vs 7.48%; OR, 0.47; 95% CI, 0.28-0.77). At follow-up to 18 months, breastfeeding rates and weight were significantly (P < .05) higher over time in the FICare group.
CONCLUSIONS
FICare was feasible in Chinese neonatal intensive care units and was associated with reduced hospital LOS, medical expenditures, and rates of adverse outcomes.",2020,"At follow-up to 18 months, breastfeeding rates and weight were significantly (p<0.05) higher over time in the FICare group.
","['preterm infants in China', '601 preterm infants from 11 neonatal intensive care units (FICare, n=298; control, n=303', 'Preterm Infants in China']","['Family Integrated Care (FICare', 'FICare and standard care']","['nosocomial infections, duration of supplemental oxygen, breastfeeding, and weight gain', 'length of stay (LOS', 'antibiotic exposure', 'Unadjusted LOS', 'breastfeeding rates and weight', 're-hospitalization rates', 'duration of hospitalization, medical expenditures and rates of adverse outcomes', 'total medical expenditures', 'nosocomial infection rates', 'weight gain velocity', 'LOS', 'duration of supplemental oxygen', 'breastfeeding rates']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0010356', 'cui_str': 'Cross infection'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",601.0,0.312111,"At follow-up to 18 months, breastfeeding rates and weight were significantly (p<0.05) higher over time in the FICare group.
","[{'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Hei', 'Affiliation': ""Neonatal Center, Beijing Children's Hospital, Capital Medical University, Beijing, China; National Center of Children's Health, Beijing, China. Electronic address: heimingyan@bch.com.cn.""}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Pediatrics, Southeast University Affiliated Xuzhou Hospital, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Third Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xirong', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': ""Department of Neonatology, Hunan Children's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Zhankui', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Northwest Women and Children's Hospital, Xi'an, Shaanxi, China.""}, {'ForeName': 'Shiwen', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Department of Neonatology, Hubei Province Women and Children Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Qianshen', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Shenzhen Maternal and Childcare Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Neonatology, Nanjing Maternity and Child Health Care Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology, Gansu Provincial Maternity and Childcare Hospital, Lanzhou, Gansu, China.'}, {'ForeName': 'Shaohan', 'Initials': 'S', 'LastName': 'Nong', 'Affiliation': ""Department of Pediatrics, Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China.""}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neonatology, Kunming Maternal and Child Healthcare Hospital, Kunming, Yunnan, China.'}, {'ForeName': 'Yanchen', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Chinese Neonatal Network, Fudan Children's Hospital, Shanghai, China.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Shoo K', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, Toronto, Ontario, Canada; Department of Pediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada; Department of Pediatrics, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.09.006']
1906,32900552,"Reply to Sachin Malde, Arun Sahai, and Eskinder Solomon's Letter to the Editor re: Marcus J. Drake, Amanda L. Lewis, Grace J. Young, et al. Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals. Eur Urol 2020;78:701-10.",,2020,,"['26 Hospitals', 'Men Considering Prostate Surgery']",[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}]",[],[],,0.0841017,,"[{'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK. Electronic address: marcus.drake@bui.ac.uk.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Athene', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration, Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",European urology,['10.1016/j.eururo.2020.08.037']
1907,32900553,"Re: Marcus J. Drake, Amanda L. Lewis, Grace J. Young, et al. Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals. Eur Urol 2020;78:701-10.",,2020,,"['26 Hospitals', 'Men Considering Prostate Surgery']",[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}]",[],[],,0.152037,,"[{'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Malde', 'Affiliation': ""Department of Urology, Guy's Hospital, London, UK. Electronic address: sachin.malde@gstt.nhs.uk.""}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sahai', 'Affiliation': ""Department of Urology, Guy's Hospital, London, UK.""}, {'ForeName': 'Eskinder', 'Initials': 'E', 'LastName': 'Solomon', 'Affiliation': ""Department of Urology, Guy's Hospital, London, UK.""}]",European urology,['10.1016/j.eururo.2020.08.026']
1908,32901330,Safety Profile and Adverse Events of Special Interest for Fruquintinib in Chinese Patients with Previously Treated Metastatic Colorectal Cancer: Analysis of the Phase 3 FRESCO Trial.,"INTRODUCTION
In FRESCO (Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer Patients) trial, fruquintinib demonstrated a statistically significant and clinically meaningful overall survival benefit in Chinese patients with metastatic colorectal cancer (mCRC). However, its safety profile, including adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI), is not well known. The present analysis evaluated the safety profile and AESIs for fruquintinib in the FRESCO trial.
METHODS
In FRESCO, eligible Chinese patients were randomized (2:1) to receive fruquintinib (5 mg once daily for 3 weeks, followed by 1 week off in 28-day cycles) or placebo plus best supportive care. Treatment-related AESIs and time to first occurrence of AESIs were summarized. Treatment-related TEAEs by age, sex, and BMI were also summarized.
RESULTS
A total of 266 patients (95.7%) in the fruquintinib group and 97 (70.8%) in the placebo group had at least one treatment-related TEAE; the mean relative dose intensity was 92% and 98%, respectively. In the fruquintinib group, the most common (in > 40% of patients) treatment-related AESIs were hypertension (55.4%), palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR)] (49.3%), and proteinuria (42.1%). The most common treatment-related grade ≥ 3 AESIs (≥ 3% of patients) were hypertension (21.2%), HFSR (10.8%), and proteinuria (3.2%); the median time to onset of these events was 10, 21, and 20 days, respectively. Subgroup analysis by age, sex, and BMI revealed that the frequencies of treatment-related TEAEs were similar across all subgroups, and were consistent with the overall safety profile of fruquintinib.
CONCLUSIONS
The most common treatment-related grade ≥ 3 AEs were hypertension, HFSR, and proteinuria. The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
TRIAL REGISTRATION
Clinical Trials identifier NCT02314819.",2020,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
","['eligible Chinese patients', 'Chinese Patients with Previously Treated Metastatic Colorectal Cancer', 'Chinese patients with metastatic colorectal cancer (mCRC']","['placebo', 'placebo plus best supportive care']","['adverse events of special interest (AESIs) and treatment-emergent adverse events (TEAEs) by age, sex, and body mass index (BMI', 'palmar-plantar erythrodysesthesia syndrome [known as hand-foot skin reaction (HFSR', 'HFSR', 'safety profile and AESIs', 'hypertension']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222289', 'cui_str': 'Skin structure of foot'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",266.0,0.204187,"The treatment-related TEAE profile of fruquintinib in Chinese patents with mCRC was comparable among different subgroups and consistent with that reported in the overall population.
","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Tongji University East Hospital, Shanghai, China.'}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Department of Medical Oncology, Shanghai Medical College, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Medical Oncology, The Sixth Hospital Affiliated to Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Nantong Cancer Hospital, Nantong, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology, The Second Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Haijun', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ruihua', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Department of Medical Oncology, Sir Run Run Shaw Hospital, Hangzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'Department of Medical Oncology, Jiangsu Provincial Hospital, Nanjing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Oncology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The First Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.'}, {'ForeName': 'Tianshu', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Oncology, Fudan University Zhongshan Hospital, Shanghai, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': ""Department of Medical Oncology, Guangdong Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Changping', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Oncology, The First People's Hospital of Changzhou, Changzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Jilin Province Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, The Fifth Medical Center of Chinese, PLA General Hospital, Beijing, China.'}, {'ForeName': 'Donghui', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Shanghai Jiao Tong University Affiliated First People's Hospital, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Oncology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Medical College Qingdao University, Qingdao, China.'}, {'ForeName': 'Peiguo', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': 'Department of Medical Oncology, Xiangya Hospital of Central South University, The Third Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Haihui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Oncology, Liuzhou Worker's Hospital, Liuzhou, China.""}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, Beijing University ShenZhen Hospital, Beijing University, Shenzhen, China.'}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Xuzhou Medical College, Xuzhou Medical College, Xuzhou, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Hutchison MediPharma Limited, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Rubing', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Lilly China, Drug Development and Medical Affairs Center, Shanghai, China.'}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Cancer Center of Jinling Hospital, Nanjing, China. shukui_qin123@hotmail.com.'}]",Advances in therapy,['10.1007/s12325-020-01477-w']
1909,32915426,Is There An Advantage of Using Dingkun Pill () alone or in Combination with Diane-35 for Management of Polycystic Ovary Syndrome? A Randomized Controlled Trial.,"OBJECTIVE
To evaluate the effects of Chinese medicine Dingkun Pill () alone or in combination with Diane-35 on patients with polycystic ovary syndrome (PCOS).
METHODS
This is a prospective randomized controlled trial conducted at Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017. Totally 117 PCOS patients were randomly assigned to the Dingkun Pill group (38 cases), Diane-35 group (40 cases), or combined group (39 cases). Patients in the Dingkun Pill group or Diane-35 group took daily 7 g of oral Dingkun Pill or 1 tablet of oral Diane-35, respectively, for 21 consecutive days followed by 7 drug-free days. And the combined group received a combination of Dingkun Pill and Diane-35. The treatment course was 3 months. Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores were recorded at baseline and after 3-month treatment.
RESULTS
Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01). After treatment, TC and FFA in the Dingkun Pill group were significantly lower than the Diane-35 group (P<0.05 or P<0.01); TT was lower and regular menstruation rate was higher in the Diane-35 and combined groups than the Dingkun Pill group (P<0.01), and no differences were observed between Diane-35 group and combined group (P>0.05).
CONCLUSIONS
Dingkun Pill showed better effects than Diane-35 in improving insulin sensitivity, lowering TC and FFA. Diane-35 was more efficient in regulating menstruation and lowering androgen than Dingkun Pill. Combination of Dingkun Pill and Diane-35 may be a better choice to regulate menstruation, lower androgens while improve glucose metabolism in PCOS patients. (Registered on ClinicalTrials.gov, registration No. NCT03264638).",2020,"Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01).","['Totally 117 PCOS patients', 'PCOS patients', 'Peking Union Medical College Hospital Beijing, China, from December 2016 to September 2017', 'patients with polycystic ovary syndrome (PCOS']","['Diane-35 group took daily 7 g of oral Dingkun Pill', 'Dingkun Pill', 'Dingkun Pill () alone or in Combination with Diane-35', 'combination of Dingkun Pill and Diane-35', 'Chinese medicine Dingkun Pill () alone or in combination with Diane-35']","['insulin sensitivity, lowering TC and FFA', 'TC and FFA', 'QUICKI', 'TC, LDL-C and FFA', 'acne scores', 'glucose metabolism', 'Fasting plasma glucose and insulin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), free fatty acids (FFA) and sex hormones were analyzed, quantitative insulin sensitivity check index (QUICKI) was calculated, and menstruation and acne scores', 'LDL-C', 'TG', 'regular menstruation rate', 'total testosterone (TT) and menstruation regularity', 'TC']","[{'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0113572', 'cui_str': 'Diane-35'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}]",117.0,0.0661986,"Compared with before treatment, QUICKI decreased significantly in the Dingkun Pill and combined groups after 3-month treatment (P<0.05); TC, LDL-C and FFA decreased significantly in the Dingkun Pill group (P<0.01), LDL-C also decreased obviously in the Diane-35 group (P<0.01), while TC increased significantly in the combined group (P<0.01), TG increased significantly in all groups (P<0.01); total testosterone (TT) and menstruation regularity was improved significantly in the Diane-35 and combined groups (P<0.01); acne scores were improved in all groups (P<0.01).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Yan-Fang', 'Initials': 'YF', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Shi-Yang', 'Initials': 'SY', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Rui-Lin', 'Initials': 'RL', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China.'}, {'ForeName': 'Ai-Jun', 'Initials': 'AJ', 'LastName': 'Sun', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, 100730, China. saj_pumch@sina.com.'}]",Chinese journal of integrative medicine,['10.1007/s11655-020-3097-4']
1910,32856272,Single versus dual blockade of the renin-angiotensin system in patients with IgA nephropathy.,"BACKGROUND
Inhibitors of the renin-angiotensin system (RAS) are cornerstones of supportive therapy in patients with IgA nephropathy (IgAN). We analyzed the effects of single versus dual RAS blockaQueryde during our randomized STOP-IgAN trial.
METHODS
STOP-IgAN participants with available successive information on their RAS treatment regimen and renal outcomes during the randomized 3-year trial phase were stratified post hoc into two groups, i.e. patients under continuous single or dual RAS blocker therapy over the entire 3 years of the trial phase. Primary and secondary STOP-IgAN trial endpoints, i.e. frequencies of full clinical remission, eGFR-loss ≥ 15 and ≥ 30 ml/min/1.73 m 2 and ESRD onset, were analyzed by logistic regression and linear mixed effects models.
RESULTS
Among the 112 patients included in the present analysis, 82 (73%) were maintained on single and 30 (27%) on dual RAS inhibitor therapy throughout the trial. Neither RAS blocker strategy significantly affected full clinical remission, eGFR-loss rates, onset of ESRD. Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase. This was particularly evident in patients without additional immunosuppression during the randomized trial phase, where proteinuria increased by 0.2 g/g creatinine in the dual RAS blockade group. In contrast, proteinuria decreased in patients under single RAS blocker therapy by 0.3 g/g creatinine. The course of eGFR remained stable and did not differ between the RAS treatment strategies.
CONCLUSION
In the STOP-IgAN cohort, neither RAS blocker regimen altered renal outcomes. Patients on dual RAS blockade even exhibited higher proteinuria over the 3-year trial phase.",2020,Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase.,"['patients with IgA nephropathy (IgAN', 'STOP-IgAN participants with available successive information on their RAS treatment regimen and renal outcomes during the randomized 3-year trial phase were stratified post hoc into two groups, i.e. patients under', '112 patients included in the present analysis, 82 (73%) were maintained on single and 30 (27%) on dual RAS inhibitor therapy throughout the trial', 'patients with IgA nephropathy']","['renin-angiotensin system', 'renin-angiotensin system (RAS', 'dual RAS blockade', 'continuous single or dual RAS blocker therapy', 'RAS blocker']","['frequencies of full clinical remission, eGFR-loss\u2009≥\u200915 and\u2009≥', 'renal outcomes', 'full clinical remission, eGFR-loss rates, onset of ESRD', 'Proteinuria']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",112.0,0.114681,Proteinuria moderately increased in patients under dual RAS blockade by 0.1 g/g creatinine during the 3-year trial phase.,"[{'ForeName': 'David Paul', 'Initials': 'DP', 'LastName': 'Lennartz', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Seikrit', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wied', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fitzner', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Eitner', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Ralf-Dieter', 'Initials': 'RD', 'LastName': 'Hilgers', 'Affiliation': 'Department of Medical Statistics, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rauen', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Floege', 'Affiliation': 'Division of Nephrology and Clinical Immunology, RWTH Aachen University, Pauwelsstr. 30, 52057, Aachen, Germany. jfloege@ukaachen.de.'}]",Journal of nephrology,['10.1007/s40620-020-00836-8']
1911,32865660,Qualitative Process Evaluation of Rural Schools: Uptake of Change Processes and Contextual Factors Influencing Implementation Within a Primary Prevention Program for Youth.,"Sexual violence (SV), homophobic name-calling, and bullying commonly occur in school settings. As such, comprehensive school-based violence prevention strategies are needed. Recent calls in prevention science argue that investigations of preventive interventions must move beyond simply testing if programs work; rather, they must also examine how interventions work. The purpose of this study was to explore the differential uptake of salient change mechanisms of a school-based primary prevention program, Sources of Strength (Sources) in rural schools, and examine contextual factors that may influence implementation outcomes in rural contexts. As a supplement to a randomized controlled trial of Sources in 20 high schools in Colorado, the present project utilized a rigorous qualitative design to conduct staff focus groups and student interviews within four schools (two intervention and two waitlist schools) that participated in the RCT. Results suggest variability in uptake of Sources key processes (expansion of networks to build connections, school-wide activities, and staff support) in intervention schools. While these were indicated as non-formalized processes in waitlist schools, there was also variability in these reports. Furthermore, results revealed specific contextual factors including cultural norms, degree of rurality, and school-level buy-in/investment that impacted implementation outcomes for intervention and waitlist schools (e.g., pre-implementation readiness). Implications are discussed around alignment of a school's policies, procedures, and values with the preventative intervention in effort to support strong implementation.",2020,"The purpose of this study was to explore the differential uptake of salient change mechanisms of a school-based primary prevention program, Sources of Strength (Sources) in rural schools, and examine contextual factors that may influence implementation outcomes in rural contexts.","['20 high schools in Colorado, the present project utilized a rigorous qualitative design to conduct staff focus groups and student interviews within four schools (two intervention and two waitlist schools) that participated in the RCT', 'rural schools', 'Rural Schools', 'rural contexts', 'Youth']","['school-based primary prevention program, Sources of Strength (Sources']","['specific contextual factors including cultural norms, degree of rurality, and school-level']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036375', 'cui_str': 'School'}]",20.0,0.0175581,"The purpose of this study was to explore the differential uptake of salient change mechanisms of a school-based primary prevention program, Sources of Strength (Sources) in rural schools, and examine contextual factors that may influence implementation outcomes in rural contexts.","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Yoder', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Williford', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA. anne.williford@colostate.edu.'}, {'ForeName': 'Lilyana', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Dorothy L', 'Initials': 'DL', 'LastName': 'Espelage', 'Affiliation': 'School of Education, University of North Carolina-Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'LoMurray', 'Affiliation': 'Sources of Strength, Lakewood, CO, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ruiz', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Kennedy', 'Affiliation': 'School of Social Work, Colorado State University, Fort Collins, CO, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01163-x']
1912,32866619,Aerobic exercise training partially reverses the impairment of Nrf2 activation in older humans.,"Nuclear factor erythroid-2-related factor 2 (Nrf2), is an inducible transcription factor that improves redox balance through stimulating antioxidant gene expression. In older humans the Nrf2 response to a single bout of acute exercise is blunted compared to young indicating impaired redox signaling. The purpose of this randomized controlled trial was to investigate if the signaling impairment could be reversed with exercise training in older men and women, while also comparing to young. Young (18-28y, n = 21) and older (≥60y, n = 19) men and women were randomized to 8-week aerobic exercise training (ET; 3 d/wk, 45 min/d) or a non-exercise control group (CON). Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein were measured in PBMCs in response to acute exercise trial (AET; 30-min cycling at 70% VO 2 peak pre- and post-intervention at 7 timepoints (Pre, +10 m, +30 m, +1 h, +4 h, +8 h, +24 h). Young had greater Nrf2 signaling response compared to older at pre-intervention (p = 0.05), whereas the older had significantly higher basal Nrf2 levels (p = 0.004). ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05). The degree of restoration in Nrf2 signaling response was related to the degree of change in basal Nrf2 (p = 0.039), which was driven by older adults (p = 0.014). Lower basal nuclear Nrf2 levels were associated with changes seen in AET responses for Nrf2 and GCLC protein, as well as NQO1 and GCLC mRNA. Together these data demonstrate that exercise training improves Nrf2 signaling and downstream gene expression and that lower basal Nrf2 levels are associated with a more dynamic acute response. Our results provide evidence that the impaired Nrf2 signaling in sedentary older adults can be restored to a degree with moderate exercise training, albeit not to the level seen in young. CLINICALTRIALS.GOV ID: NCT03419988.",2020,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"['sedentary older adults', 'older humans', 'older men and women, while also comparing to young', 'Young (18-28y, n\u202f=\u202f21) and older (≥60y, n\u202f=\u202f19) men and women']","['Aerobic exercise training', 'aerobic exercise training (ET; 3\u202fd/wk, 45\u202fmin/d) or a non-exercise control group (CON', 'exercise training', 'CON']","['Nrf2 nuclear localization, gene expression for NQO1, HO1, and GCLC, and GCLC protein', 'Nrf2 signaling response', 'basal Nrf2 levels', 'basal Nrf2 expression', 'impairment of Nrf2 activation', 'Nrf2 signaling and downstream gene expression']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1136197', 'cui_str': 'NAD(P)H dehydrogenase (quinone) 1, human'}, {'cui': 'C0018969', 'cui_str': 'Heme oxygenase (decyclizing)'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0522506', 'cui_str': 'Downstream'}]",,0.0441431,ET decreased basal Nrf2 expression compared to CON (p = 0.032) and improved the Nrf2 signaling response in both young and older (p < 0.05).,"[{'ForeName': 'Ethan L', 'Initials': 'EL', 'LastName': 'Ostrom', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA.'}, {'ForeName': 'Tinna', 'Initials': 'T', 'LastName': 'Traustadóttir', 'Affiliation': 'Department of Biological Sciences, Northern Arizona University, Flagstaff, AZ, USA. Electronic address: tinna.traustadottir@nau.edu.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.08.016']
1913,32873496,The Protective Impact of Telemedicine on Persons With Dementia and Their Caregivers During the COVID-19 Pandemic.,"OBJECTIVES
Social distancing under the COVID-19 pandemic has restricted access to community services for older adults with neurocognitive disorder (NCD) and their caregivers. Telehealth is a viable alternative to face-to-face service delivery. Telephone calls alone, however, may be insufficient. Here, we evaluated whether supplementary telehealth via video-conferencing platforms could bring additional benefits to care-recipient with NCD and their spousal caregivers at home.
PARTICIPANTS
Sixty older adults NCD-and-caregiver dyads were recruited through an activity center.
DESIGN, INTERVENTION
The impact of additional services delivered to both care-recipient and caregiver through video conference (n = 30) was compared with telehealth targeted at caregivers by telephone only (n = 30), over 4 weeks in a pretest-post-test design. Interviews and questionnaires were conducted at baseline and study's end.
MEASUREMENTS, RESULTS
Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2 = 0.50). It also reversed the falling trend in quality of life observed in the telephone only group (QoL-AD, η p 2 = 0.23). Varying degrees of improvements in physical and mental health (Short-Form 36 v2), perceived burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale) were observed among caregivers in the video-conferencing group, which were absent in the telephone-only group (η p 2 = 0.23-0.51).
CONCLUSION
Telemedicine by video conference was associated with improved resilience and wellbeing to both people with NCD and their caregivers at home. The benefits were visible already after 4 weeks and unmatched by telephone alone. Video conference as the modus operandi of telehmedicine beyond the context of pandemic-related social distancing should be considered.",2020,"MEASUREMENTS, RESULTS
Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2 = 0.50).","['Persons With Dementia and Their Caregivers During the COVID-19 Pandemic', 'Sixty older adults NCD-and-caregiver dyads were recruited through an activity center', 'older adults with neurocognitive disorder (NCD) and their caregivers']","['additional services delivered to both care-recipient and caregiver through video conference (n\u202f=\u202f30) was compared with telehealth targeted at caregivers by telephone', 'Telemedicine']","['physical and mental health', 'quality of life', 'burden (Zarit Burden Interview Scale) and self-efficacy (Revised Caregiving Self-Efficacy Scale', 'Montreal Cognitive Assessment']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4041080', 'cui_str': 'Neurocognitive disorder'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",60.0,0.061643,"MEASUREMENTS, RESULTS
Supplementary telemedicine had averted the deterioration in the Montreal Cognitive Assessment evident in the telephone-only group (η p 2 = 0.50).","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department (EWHY), Kowloon Hospital, Hong Kong, China.'}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Salvation Army Hong Kong & Macau Command, Tai Po Multi-service Centre for Senior Citizen.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Women's Welfare Club Western District, Hong Kong Chung Hok Elderly Centre, Hong Kong, China.""}, {'ForeName': 'Daniel Ting-Hoi', 'Initials': 'DT', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Benjamin K', 'Initials': 'BK', 'LastName': 'Yee', 'Affiliation': 'Department of Rehabilitation Sciences (FHYL, DTHC), The Hong Kong Polytechnic University, Hong Kong, China.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.07.019']
1914,32871336,Single dose testosterone administration modulates the temporal dynamics of distractor processing.,"Some evidence suggests that testosterone can increase attentional orientation toward biologically relevant stimuli and increase sustained attention during goal-oriented behaviors. While rare irregular distractors often capture attention involuntarily and distract us away from the task at hand, we hypothesized that testosterone might (1) facilitate attentional orientation to novel distractors that are of potential behavioral relevance and (2) inhibit information processing of distractors that are irrelevant to the task. To test this hypothesis, we investigated the effects of testosterone on distractor processing in a novelty oddball task, during which infrequent target and distractor sounds were interspersed within a series of frequent non-target sounds. Using a double-blind, placebo-controlled within-participant design, we administered a single dose of either testosterone or placebo to 34 healthy male volunteers and compared their electroencephalographic responses to distractors. Increased amplitude of the early (260-310 ms) P3 component-which has been associated with phasic arousal and alertness triggered by novel stimuli-was observed in the testosterone session than in the placebo session. This early-P3 response mediated the effect of testosterone administration on target hit rate during the task. In addition, less α-oscillation suppression-which has been associated with the inhibition of task-irrelevant information processing-was observed in response to distractors later (538-757 ms) in the testosterone session than in the placebo session. These results suggest that testosterone facilitated phasic arousal to novel distractors during the early-latency stage, which might have influenced behavioral performance during the task. Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task. Our findings highlight the role of testosterone in distractor processing, and provide a theoretical basis for treating attention-related behavioral disorders with hormone therapies.",2020,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.",['34 healthy male volunteers'],"['placebo', 'testosterone', 'testosterone or placebo']",['temporal dynamics of distractor processing'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",34.0,0.311301,"Furthermore, testosterone inhibited task-irrelevant information processing during the late-latency stage, which allowed better reorientation of attention back to the primary task.","[{'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China; Department of Psychology, University of Mannheim, Mannheim, Germany.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'School of Psychology, Shenzhen University, Shenzhen, Guangdong, China; Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, Guangdong, China. Electronic address: ww.peng0923@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104838']
1915,32880842,Cost analysis of a randomized trial of Getting to Outcomes implementation support for a teen pregnancy prevention program offered in Boys and Girls Clubs in Alabama and Georgia.,"Implementation support can improve outcomes of evidence-based programs (EBP) for adolescents, but with a cost. To assist in determining whether this cost is worthwhile, this study estimated the cost of adding Getting To Outcomes© (GTO) implementation support to a teen pregnancy and sexually transmitted infection prevention EBP called Making Proud Choices (MPC) in 32 Boys and Girls Clubs (BGCs) in Alabama and Georgia. Enhancing Quality Interventions Promoting Healthy Sexuality (EQUIPS) was a 2-year, cluster-randomized controlled trial comparing MPC with MPC + GTO. We used micro-costing to estimate costs and captured MPC and GTO time from activity logs completed by GTO staff. Key resource use and cost components were compared between the randomized groups, years, and states (to capture different community site circumstances) using 2-sample t tests. There were no significant differences between randomized groups in attendees per site, resource use, or costs for either year. However, there were significant differences between states. Adding GTO to MPC increased the societal costs per attendee from $67 to $144 (2015 US dollars) in Georgia and from $106 to $314 in Alabama. The higher Alabama cost was due to longer travel distances and to more BGC staff time spent on GTO in that state. GTO also improved adherence, classroom delivery, and condom-use intentions more in Alabama youth. Thus, Alabama's GTO-related BGC staff time costs may be better estimates of effective GTO. If teen childbearing costs taxpayers approximately $20,000 per teen birth, adding GTO to MPC would be worthwhile to society if it prevented one more teen birth per 140 attendees than MPC alone.Trial registration. ClinicalTrials.gov , NCT01818791. Registered March 26, 2013, https://clinicaltrials.gov/ct2/show/NCT01818791?term=NCT01818791&draw=2&rank=1.",2020,Adding GTO to MPC increased the societal costs per attendee from $67 to $144 (2015 US dollars) in Georgia and from $106 to $314 in Alabama.,"['32 Boys and Girls Clubs (BGCs) in Alabama and Georgia', 'Healthy Sexuality (EQUIPS', 'Boys and Girls Clubs in Alabama and Georgia']",[],"['societal costs per attendee', 'adherence, classroom delivery, and condom-use intentions more in Alabama youth', 'attendees per site, resource use, or costs for either year']","[{'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0017452', 'cui_str': 'Georgia state'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",[],"[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.124449,Adding GTO to MPC increased the societal costs per attendee from $67 to $144 (2015 US dollars) in Georgia and from $106 to $314 in Alabama.,"[{'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Herman', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA, 90407-2138, USA. pherman@rand.org.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chinman', 'Affiliation': 'RAND Corporation, 4570 Fifth Ave #600, Pittsburgh, PA, 15213, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ebener', 'Affiliation': 'RAND Corporation, 1776 Main Street, PO Box 2138, Santa Monica, CA, 90403, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Malone', 'Affiliation': 'Malone Quantitative, Durham, NC, 27705, USA.'}, {'ForeName': 'Joie', 'Initials': 'J', 'LastName': 'Acosta', 'Affiliation': 'RAND Corporation, 1200 S Hayes St, Arlington, VA, 22202, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01162-y']
1916,32877886,Effects of peripheral and different inspiratory muscle training methods in coronary artery disease patients with metabolic syndrome: A randomized-controlled trial.,"Background OBJECTIVE: To investigate the effects of peripheral muscle training (PMT) and different inspiratory muscle training (IMT) methods on respiratory functions, exercise capacity, and biochemistry parameters in coronary artery disease patients with metabolic syndrome.
METHODS
This prospective, single-blind, randomized-controlled study included 60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA] Class I-II, left ventricular ejection fraction >40%). Patients were randomly divided into three groups: neuromuscular electrical stimulation (NMES) plus PMT group (NMES + PMT group, n = 20), IMT plus PMT group (IMT + PMT group, n = 20) and PMT group (PMT group, n = 20). Treatment continued for six weeks for all groups. The NMES was applied to rectus abdominis, IMT was applied with 30% of maximal inspiratory pressures, and PMT was applied at home. Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters were measured before and after training.
RESULTS
There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05). Significant improvements in C-reactive protein and erythrocyte sedimentation rate were observed in NMES + PMT and IMT + PMT groups (p < 0.05). Among the groups, there was a significant difference in maximal inspiratory pressure (p = 0.02) and erythrocyte sedimentation rate (p = 0.037) in favor of NMES + PMT group (p < 0.05).
CONCLUSION
Our study results showed significant improvements in respiratory functions, exercise capacity, and biochemistry markers in all groups. Different IMT methods can be used in cardiopulmonary rehabilitation to improve exercise intolerance in coronary artery disease patients with metabolic syndrome.
CLINICAL TRIAL REGISTRATION NUMBER
NCT03523026.",2020,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","['coronary artery disease patients with metabolic syndrome', '60 patients of stable coronary artery disease with metabolic syndrome (New York Heart Association [NYHA']","['peripheral muscle training (PMT) and different inspiratory muscle training (IMT', 'peripheral and different inspiratory muscle training methods', 'neuromuscular electrical stimulation (NMES) plus PMT group (NMES\xa0+\xa0PMT group, n\xa0=\xa020), IMT plus PMT group (IMT\xa0+\xa0PMT group, n\xa0=\xa020) and PMT group (PMT', 'NMES']","['Spirometry, maximal inspiratory and expiratory pressure, dyspnea scores, exercise stress test, and biochemistry parameters', 'exercise intolerance', 'maximal inspiratory pressure', 'respiratory functions, exercise capacity, and biochemistry markers', 'erythrocyte sedimentation rate', 'C-reactive protein and erythrocyte sedimentation rate', 'spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O', 'respiratory functions, exercise capacity, and biochemistry parameters']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424551', 'cui_str': 'Impaired exercise tolerance'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003436', 'cui_str': 'Antistreptolysin O'}]",60.0,0.028139,"There were significant improvements in spirometric tests, respiratory muscle strength, dyspnea scores, exercise capacity, fasting blood glucose, and antistreptolysin O after treatment in all groups (p < 0.05).","[{'ForeName': 'Kıymet', 'Initials': 'K', 'LastName': 'Muammer', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Mutluay', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Medipol University, Istanbul, Turkey. Electronic address: fmutluay@medipol.edu.tr.'}, {'ForeName': 'Rengin', 'Initials': 'R', 'LastName': 'Demir', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Alev Arat', 'Initials': 'AA', 'LastName': 'Özkan', 'Affiliation': 'Department of Cardiology, Cardiology Institute, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106119']
1917,32885874,Dermoscopy image-based self-learning on computer improves diagnostic performance of medical students compared with classroom-style lecture in ultra-short period.,"The educational effectiveness of dermoscopy image-based self-learning on a computer for medical students has not been well examined. To assess the effect of an image-based self-learning session on the dermoscopic diagnostic performance for malignant melanoma (MM), basal cell carcinoma, melanocytic nevus and seborrheic keratosis (SK) on non-acral regions in comparison with a conventional classroom-style lecture, 114 fourth-year medical students (mean age, 23.7 years; male : female, 73:41) were enrolled. The subjects were randomly assigned to either a self-learning to lecture (SL) or lecture to self-learning (LS) group to receive a 15-min image-based self-learning computer session and a 15-min video lecture session in different orders. The user interface of the digital content was the same as that on a website (https://dz-image.casio.jp). Diagnostic performance was determined using the total number of correct answers for the four diseases and by malignancy prediction in examination A (before training), B (after receiving one session) and C (after receiving both sessions). The examinations were all unique and contained five dermoscopic images each of the four diseases. The total number of correct answers and malignancy prediction results for examination B were significantly higher in the SL group than in LS (11.6 and 15.2 vs 10.1 and 13.4, respectively; both P < 0.01), with no remarkable differences for examination C (13.5 and 16.8 vs 13.3 and 16.4, respectively; P = 0.62 and P = 0.21). In subanalyses, the number of correct answers for SK in examination B was significantly higher in the SL group (3.6 vs. 1.8, P < 0.01), while that for MM was significantly lower (2.2 vs 3.0, P < 0.01). Diagnostic performance was comparable between sexes for examination B. In conclusion, computer-assisted dermoscopy image-based self-learning may be a suitable and non-inferior alternative to classroom-style instruction for medical students within an ultra-short training period.",2020,"The total number of correct answers and malignancy prediction results for examination B were significantly higher in the SL group than in LS (11.6 and 15.2 vs 10.1 and 13.4, respectively; both P < 0.01), with no remarkable differences for examination C (13.5 and 16.8 vs 13.3 and 16.4, respectively; P = 0.62 and P = 0.21).","['malignant melanoma (MM), basal cell carcinoma, melanocytic nevus and seborrheic keratosis (SK) on non-acral regions in comparison with a conventional classroom-style lecture, 114 fourth-year medical students (mean age, 23.7\xa0years; male\xa0:\xa0female, 73:41) were enrolled', 'medical students']","['classroom-style lecture', 'dermoscopy image-based self-learning', 'self-learning to lecture (SL) or lecture to self-learning (LS) group to receive a 15-min image-based self-learning computer session and a 15-min video lecture session', 'image-based self-learning session', 'Dermoscopy image-based self-learning']","['Diagnostic performance', 'dermoscopic diagnostic performance', 'total number of correct answers and malignancy prediction results for examination B', 'number of correct answers for SK in examination B', 'examination C', 'diagnostic performance']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0027962', 'cui_str': 'Melanocytic nevus'}, {'cui': 'C0022603', 'cui_str': 'Seborrheic keratosis'}, {'cui': 'C0439746', 'cui_str': 'Acral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C1449565', 'cui_str': 'Dermatoscopy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0022603', 'cui_str': 'Seborrheic keratosis'}]",,0.0200044,"The total number of correct answers and malignancy prediction results for examination B were significantly higher in the SL group than in LS (11.6 and 15.2 vs 10.1 and 13.4, respectively; both P < 0.01), with no remarkable differences for examination C (13.5 and 16.8 vs 13.3 and 16.4, respectively; P = 0.62 and P = 0.21).","[{'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Minagawa', 'Affiliation': 'Department of Dermatology, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Yasutomo', 'Initials': 'Y', 'LastName': 'Mikoshiba', 'Affiliation': 'Department of Dermatology, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Koga', 'Affiliation': 'Department of Dermatology, Shinshu University School of Medicine, Matsumoto, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'Okuyama', 'Affiliation': 'Department of Dermatology, Shinshu University School of Medicine, Matsumoto, Japan.'}]",The Journal of dermatology,['10.1111/1346-8138.15592']
1918,32891234,Financial incentives to promote retention in care and viral suppression in adults with HIV initiating antiretroviral therapy in Tanzania: a three-arm randomised controlled trial.,"BACKGROUND
Financial incentives promote use of HIV services and might support adherence to the sustained antiretroviral therapy (ART) necessary for viral suppression, but few studies have assessed a biomarker of adherence or evaluated optimal implementation. We sought to determine whether varying sized financial incentives for clinic attendance effected viral suppression in patients starting ART in Tanzania.
METHODS
In a three-arm, parallel-group, randomised controlled trial at four health facilities in Shinyanga region, Tanzania, adults aged 18 years or older with HIV who had started ART within the past 30 days were randomly assigned (1:1:1) using a tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10 000 Tanzanian Shillings (TZS; about US$4·50) or 22 500 TZS (about $10·00). There were no formal exclusion criteria. Participants were masked to the existence of two incentive sizes. Incentives were provided for up to 6 months via mobile health technology (mHealth) that linked biometric attendance monitoring to automated mobile payments. We evaluated the primary outcome of retention in care with viral suppression (<1000 copies per mL) at 6 months using logistic regression. This trial is registered with ClinicalTrials.gov, NCT03351556.
FINDINGS
Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group). All participants were included in the primary intention-to-treat analysis. At 6 months, approximately 134 (73%) participants in the control group remained in care and had viral suppression, compared with 143 (83%) in the smaller incentive group (risk difference [RD] 9·8, 95% CI 1·2 to 18·5) and 150 (86%) in the larger incentive group (RD 13·0, 4·5 to 21·5); we identified a positive trend between incentive size and viral suppression (p trend=0·0032), although the incentive groups did not significantly differ (RD 3·2, -4·6 to 11·0). Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
INTERPRETATION
Small financial incentives delivered using mHealth can improve retention in care and viral suppression in adults starting HIV treatment. Although further research should investigate the durability of effects from short-term incentives, these findings strengthen the evidence for implementing financial incentives within standard HIV care.
FUNDING
National Institute of Mental Health at the US National Institutes of Health.",2020,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","['adults with HIV initiating antiretroviral therapy in Tanzania', 'All participants were included in the primary intention-to-treat analysis', 'adults starting HIV treatment', 'adults aged 18 years or older with HIV who had started ART within the past 30 days', 'Between April 24 and Dec 14, 2018, 530 participants were randomly assigned to an incentive strategy (184 in the control group, 172 in the smaller incentive group, and 174 in the larger incentive group', 'patients starting ART in Tanzania']",['tablet-based application (stratified by site) to receive usual care (control group) or to receive a cash incentive for monthly clinic attendance in one of two amounts: 10\u2008000 Tanzanian Shillings (TZS; about US$4·50) or 22\u2008500 TZS'],"['viral suppression', 'retention in care with viral suppression', 'incentive size and viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",530.0,0.294879,"Adverse events included seven (4%) deaths in the control group and 11 (3%) deaths in the intervention groups, none related to study participation.
","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'Fahey', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA. Electronic address: cfahey@berkeley.edu.'}, {'ForeName': 'Prosper F', 'Initials': 'PF', 'LastName': 'Njau', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania; Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Katabaro', 'Affiliation': 'Health for a Prosperous Nation, Dar es Salaam, Tanzania.'}, {'ForeName': 'Rashid S', 'Initials': 'RS', 'LastName': 'Mfaume', 'Affiliation': 'Ministry of Health, Community Development, Gender, Elderly and Children, Dodoma, Tanzania.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Natalino', 'Initials': 'N', 'LastName': 'Mwenda', 'Affiliation': 'Rasello, Dar es Salaam, Tanzania.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'Bradshaw', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Dow', 'Affiliation': 'Department of Health Policy and Management, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Padian', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Jewell', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sandra I', 'Initials': 'SI', 'LastName': 'McCoy', 'Affiliation': 'Division of Epidemiology, School of Public Health, University of California, Berkeley, CA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30230-7']
1919,32894239,The effect of aerobic exercise training on postmenopausal patients with knee osteoarthritis.,"BACKGROUND
Knee osteoarthritis (OA) is a common musculoskeletal problem encountered in the postmenopausal period.
OBJECTIVE
This study aimed to determine the impact of aerobic exercise on functional limitation, exercise tolerance, and performance tests in postmenopausal women with knee OA.
METHODS
A total of 50 women (aged between 48-78) with grade 2-3 knee OA according to the Kellgren-Lawrence radiographic scale were enrolled. OA-specific physical performance tests (40 m Fast-Paced Walk Test (40mFPWT), 30 s Chair Stand Test (30sCST), Stair Climb Test (9-step SCT)), six-minute walk test (6MWT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Visual Analogue Scale (VAS) were performed. Fifty patients were randomized to either the treatment or control groups. The treatment group received an additional aerobic exercise training along with a combined physiotherapy program for six weeks. The aerobic exercise program was carried out by the same physiotherapist every weekday (five days) for six weeks. The control group only received a combined physiotherapy program for six weeks.
RESULTS
The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
CONCLUSIONS
Consequently, this study provides an insight into the efficacy of the aerobic exercise program applied along with a combined physiotherapy program in postmenopausal women with knee OA.",2020,"The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
","['postmenopausal patients with knee osteoarthritis', 'Fifty patients', '50 women (aged between 48-78) with grade 2-3 knee OA according to the Kellgren-Lawrence radiographic scale were enrolled', 'postmenopausal women with knee OA']","['combined physiotherapy program', 'additional aerobic exercise training', 'OA-specific physical performance tests (40\xa0m Fast-Paced Walk Test (40mFPWT', 'aerobic exercise', 'aerobic exercise program', 'aerobic exercise training']","['30\xa0s Chair Stand Test (30sCST), Stair Climb Test (9-step SCT)), six-minute walk test (6MWT), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Visual Analogue Scale (VAS', 'performance tests, WOMAC scores, and the distance covered in 6MWT', 'functional limitation, exercise tolerance, and performance tests', 'VAS scores']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]","[{'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0796149', 'cui_str': 'Scott syndrome'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",50.0,0.040622,"The post-treatment comparisons of the two groups yielded similar SCT results (p> 0.05), while VAS scores, the results of all performance tests, WOMAC scores, and the distance covered in 6MWT were significantly higher in the treatment group (p< 0.05).
","[{'ForeName': 'Filiz', 'Initials': 'F', 'LastName': 'Kılıç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Demirgüç', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Sanko University, Gaziantep, Turkey.'}, {'ForeName': 'Saniye Aydoğan', 'Initials': 'SA', 'LastName': 'Arslan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Esra Dilek', 'Initials': 'ED', 'LastName': 'Keskin', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medical Sciences, Kirikkale University, Kirikkale, Turkey.'}, {'ForeName': 'Müyesser', 'Initials': 'M', 'LastName': 'Aras', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Yildirim Beyazit University, Ankara, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-191712']
1920,32891607,Partial sleep deprivation affects endurance performance and psychophysiological responses during 12-minute self-paced running exercise.,"PURPOSE
This study aimed to investigate the effects of partial sleep deprivation (PSD) on physical performance and psychophysiological responses during 12-minute self-paced running exercise.
METHODS
Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm) performed, in a randomized order, two running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD (bedtime from 00:30 h to 04:30 h). Core temperature and motivation were recorded before exercise. Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 )) were assessed during exercise. Blood lactate concentration [La] was assessed 2 min after exercise. Simple reaction time (SRT), mood and barrage test (BT) were assessed before and after exercise.
RESULTS
Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=-6% for covered distance), following PSD, were obtained compared to CONT. Similarly, PSD attenuated core temperature (p=0.01, d=0.84), HR (p=0.006, ɳp 2 =0.45), VE (p=0.001, ɳp 2 =0.73), VO 2 (p=0.001, ɳp 2 =0.96), BT (p<0.0005, ɳp 2 =0.86), SRT (p=0.0009, ɳp 2 =0.44) and mood (p<0.0005). However, VCO 2 , [La] and motivation score were not affected by sleep conditions.
CONCLUSION
The decrease of running performance and the increase of physical discomfort after PSD could be the origin of the lower cardio-respiratory responses to the 12-minute self-paced exercise. Effective strategies should be introduced to overcome the deterioration of physical performance and physiological responses after PSD.",2020,"RESULTS
Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","['Twenty runners (20.8±1.1 years, 70.6±4.9 kg, 175.1±3.9 cm']","['12-minute self-paced running exercise', 'Partial sleep deprivation', 'running self-paced field exercises after a normal sleep night (CONT, bedtime from 22:30 h to 06:30 h) and one night of PSD', 'partial sleep deprivation (PSD']","['PSD attenuated core temperature', 'running performance', 'SRT', 'VCO 2 , [La] and motivation score', 'physical performance and psychophysiological responses', 'endurance performance and psychophysiological responses', 'Blood lactate concentration [La', 'Simple reaction times (SRT), mood and barrage test (BT', 'Core temperature and motivation', 'Speed, covered distance, heart rate (HR), rating of perceived exertion (RPE) and respiratory parameters (i.e., minute ventilation (VE), oxygen uptake (VO 2 ) and carbon dioxide production (VCO 2 ', 'lower physical performance', 'physical discomfort']","[{'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.0445421,"RESULTS
Higher RPE (p=0.01, d=0.90) and lower physical performance (i.e., p=0.001, d=0.59 for running speed and p=0.01, d=0.7 and Δ (%)=","[{'ForeName': 'Wajdi', 'Initials': 'W', 'LastName': 'Souissi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Hammouda', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France; Research Laboratory, Molecular Bases of Human Pathology, LR19ES13, Faculty of Medicine, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayachi', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Achraf', 'Initials': 'A', 'LastName': 'Ammar', 'Affiliation': 'Institute of Sport Science, Otto-von-Guericke University, Magdeburg, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khcharem', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia; Laboratory of Pharmacology, Faculty of Medicine, University of Sfax, Tunisia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Marco', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Souissi', 'Affiliation': 'Research Laboratory, Education, Motricity, Sport and Health, UR15JS01, High Institute of Sport and Physical Education, University of Sfax, Tunisia.'}, {'ForeName': 'Tarak', 'Initials': 'T', 'LastName': 'Driss', 'Affiliation': 'Interdisciplinary Laboratory in Neurosciences, Physiology and Psychology: Physical activity, Health and learning (LINP2-2APS), UFR STAPS, UPL, Paris Nanterre University, Nanterre, France. Electronic address: tarak.driss@parisnanterre.fr.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113165']
1921,32891678,The impact of shared decision making with patient decision aids on the rotavirus vaccination rate in children: A randomized controlled trial.,"Rotavirus vaccination reduces the incidence and severity of acute gastroenteritis due to rotavirus infection. However, because of a lack of understanding and private payment for the rotavirus vaccine, the rotavirus vaccination rate is still low in some countries. We intended to assess the impact of shared decision-making (SDM) with the assistance of patient decision aids (PDAs) on the rotavirus vaccination rate, and the knowledge, confidence, and congruence of value among baby's parents when decision-making. The study was a two-group, outcome assessor-blind, randomized, controlled trial. The families of 1-month-old infants for routine vaccination were enrolled; they were divided randomly into non-SDM and SDM groups. The influence of SDM on the acceptance of rotavirus vaccination was assessed when their infants were 2 months old. Outcome measures were decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate. The study enrolled 180 participants. SDM, parents' education level, and rotavirus vaccination of a previous child were variables that influenced acceptance of rotavirus vaccination. The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus. The rotavirus vaccination rate was 16.7% higher in the SDM group than the non-SDM group. SDM assisted with PDAs gives more information and helps infants' families understand what they need, reduces their decision conflict, and increases their baby's vaccination against rotavirus, which promotes public health. The clinical trial is registered at ClinicalTrials.gov (NCT03804489).",2020,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","['children', '180 participants', 'families of 1-month-old infants for routine vaccination were enrolled']","['shared decision-making (SDM) with the assistance of patient decision aids (PDAs', 'Rotavirus vaccination', 'SDM', 'patient decision aids', 'SDM assisted with PDAs']","['acceptance of rotavirus vaccination', 'rotavirus vaccination rate', 'decisional conflict, decision-making difficulties, and rotavirus vaccine knowledge, and the overall rotavirus vaccination rate', 'rotavirus vaccination rate, and the knowledge, confidence, and congruence of value']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",180.0,0.124641,"The SDM group scored significantly higher for understanding the information on the oral rotavirus vaccine than the non-SDM group, which helped them to decide whether to vaccinate the baby against rotavirus.","[{'ForeName': 'Sheng-Chieh', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: jacklinmails@yahoo.com.tw.'}, {'ForeName': 'Ka-Wai', 'Initials': 'KW', 'LastName': 'Tam', 'Affiliation': 'Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: kelvintam@h.tmu.edu.tw.'}, {'ForeName': 'Jean Yu-Chun', 'Initials': 'JY', 'LastName': 'Yen', 'Affiliation': 'Research Center of Biostatistics, College of Management, Taipei Medical University, Taipei, Taiwan. Electronic address: jeanycy@tmu.edu.tw.'}, {'ForeName': 'Meng-Che', 'Initials': 'MC', 'LastName': 'Lu', 'Affiliation': 'Division of Allergy, Asthma, and Immunology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Elaine Ying-Fang', 'Initials': 'EY', 'LastName': 'Chen', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Ting', 'Initials': 'YT', 'LastName': 'Kuo', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Neurology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: pedkuoyt@tmu.edu.tw.'}, {'ForeName': 'Wen-Chuan', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Pediatric Infectious Diseases, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 09009@s.tmu.edu.tw.'}, {'ForeName': 'Shu-Huey', 'Initials': 'SH', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Hematology and Oncology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: shu117@tmu.edu.tw.'}, {'ForeName': 'El-Wui', 'Initials': 'EW', 'LastName': 'Loh', 'Affiliation': 'Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan; Shared Decision Making Resource Center, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Clinical Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Center for Evidence-Based Health Care, Department of Medical Research, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: lohelwui@tmu.edu.tw.'}, {'ForeName': 'Shih-Yen', 'Initials': 'SY', 'LastName': 'Chen', 'Affiliation': 'Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan; Division of Pediatric Gastroenterology, Department of Pediatrics, Shuang Ho Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: 18159@s.tmu.edu.tw.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106244']
1922,32890472,Do Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy Minimize Postoperative Pain and Edema After Molar Extraction?,"PURPOSE
This study was designed to examine the efficacy of antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT) in reducing postoperative pain and edema after molar extractions.
METHODS
The investigators designed a single-blind randomized controlled study and enrolled subjects requiring extraction of at least one of the first or second molars. They were randomized to one of the following four groups: control group, aPDT group, LLLT group, and aPDT and LLLT group. Patients were blinded to the group assigned. The outcome variables were postoperative pain and edema. Pain intensity was measured on a visual analog scale (recorded every day for 7 days after tooth extraction). Facial edema was assessed by measuring the perimeter between the tragus, base of the jaw, and labial commissure, which was recorded once before surgery and then on the third and seventh days after surgery. Other variables were age, sex, ethnicity, decayed/missing/filled teeth, and tooth types. Appropriate univariate and bivariate statistics were computed and statistical significance was set at a value of P < .05.
RESULTS
The sample was composed of 40 patients with a mean age of 41.25 ± 13.97 years and 25 (62.5%) of them were women. There were 10 subjects in each treatment group. The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05). Postoperative pain was lowest in the aPDT + LLLT group in the 1st, 2nd, 3rd, 5th, 6th, and 7th day after tooth extraction (P < .05). There were no significant differences in edema among the groups (P > .05).
CONCLUSION
The combined use of aPDT and LLLT was effective in reducing postoperative pain. These procedures can be applied in everyday surgical practice.",2020,The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05).,"['40 patients with a mean age of 41.25\xa0±\xa013.97 years and 25 (62.5%) of them were women', 'enrolled subjects requiring extraction of at least one of the first or second\xa0molars']","['antimicrobial photodynamic therapy (aPDT) and low-level laser therapy (LLLT', 'aPDT\xa0+\xa0LLLT', 'aPDT and LLLT', 'control group, aPDT group, LLLT', 'Antimicrobial Photodynamic Therapy and Low-Level Laser Therapy']","['visual analog scale', 'edema', 'mean of postoperative pain', 'postoperative pain and edema', 'postoperative pain', 'Pain intensity', 'Postoperative pain', 'Facial edema', 'Postoperative Pain and Edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0542571', 'cui_str': 'Edema of face'}]",40.0,0.0341872,The mean of postoperative pain within the groups was associated with a significant continuous decrease over time (P < .05).,"[{'ForeName': 'Renato Silva', 'Initials': 'RS', 'LastName': 'Fraga', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil, Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil.'}, {'ForeName': 'Lívia Azeredo Alves', 'Initials': 'LAA', 'LastName': 'Antunes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil; Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil.'}, {'ForeName': 'Walter Luis Soares', 'Initials': 'WLS', 'LastName': 'Fialho', 'Affiliation': 'Professor, School of Medicine, Petropolis University, Petrópolis, RJ, Brazil.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Valente', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Cinthya Cristina', 'Initials': 'CC', 'LastName': 'Gomes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Karla Bianca Fernandes Costa', 'Initials': 'KBFC', 'LastName': 'Fontes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil.'}, {'ForeName': 'Leonardo Santos', 'Initials': 'LS', 'LastName': 'Antunes', 'Affiliation': 'Professor, Department of Specific Formation, School of Dentistry, Fluminense Federal University, Nova Friburgo, RJ, Brazil; Post-graduate Program in Dentistry School of Dentistry, Fluminense Federal University, Niterói, RJ, Brazil. Electronic address: leonardoantunes@id.uff.br.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.002']
1923,32897034,Phase 2 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis.,"BACKGROUND
Patients with bronchiectasis have frequent exacerbations that are thought to be related to neutrophilic inflammation. The activity and quantity of neutrophil serine proteases, including neutrophil elastase, are increased in the sputum of patients with bronchiectasis at baseline and increase further during exacerbations. Brensocatib (INS1007) is an oral reversible inhibitor of dipeptidyl peptidase 1 (DPP-1), an enzyme responsible for the activation of neutrophil serine proteases.
METHODS
In a phase 2, randomized, double-blind, placebo-controlled trial, we randomly assigned, in a 1:1:1 ratio, patients with bronchiectasis who had had at least two exacerbations in the previous year to receive placebo, 10 mg of brensocatib, or 25 mg of brensocatib once daily for 24 weeks. The time to the first exacerbation (primary end point), the rate of exacerbations (secondary end point), sputum neutrophil elastase activity, and safety were assessed.
RESULTS
Of 256 patients, 87 were assigned to receive placebo, 82 to receive 10 mg of brensocatib, and 87 to receive 25 mg of brensocatib. The 25th percentile of the time to the first exacerbation was 67 days in the placebo group, 134 days in the 10-mg brensocatib group, and 96 days in the 25-mg brensocatib group. Brensocatib treatment prolonged the time to the first exacerbation as compared with placebo (P = 0.03 for 10-mg brensocatib vs. placebo; P = 0.04 for 25-mg brensocatib vs. placebo). The adjusted hazard ratio for exacerbation in the comparison of brensocatib with placebo was 0.58 (95% confidence interval [CI], 0.35 to 0.95) in the 10-mg group (P = 0.03) and 0.62 (95% CI, 0.38 to 0.99) in the 25-mg group (P = 0.046). The incidence-rate ratio was 0.64 (95% CI, 0.42 to 0.98) in the 10-mg group, as compared with placebo (P = 0.04), and 0.75 (95% CI, 0.50 to 1.13) in the 25-mg group, as compared with placebo (P = 0.17). With both brensocatib doses, sputum neutrophil elastase activity was reduced from baseline over the 24-week treatment period. The incidence of dental and skin adverse events of special interest was higher with the 10-mg and 25-mg brensocatib doses, respectively, than with placebo.
CONCLUSIONS
In this 24-week trial, reduction of neutrophil serine protease activity with brensocatib in patients with bronchiectasis was associated with improvements in bronchiectasis clinical outcomes. (Funded by Insmed; WILLOW ClinicalTrials.gov number, NCT03218917.).",2020,Brensocatib treatment prolonged the time to the first exacerbation as compared with placebo (P = 0.03 for 10-mg brensocatib vs. placebo; P = 0.04 for 25-mg brensocatib vs. placebo).,"['256 patients', 'patients with bronchiectasis', 'once daily for 24 weeks', 'patients with bronchiectasis who had had at least two exacerbations in the previous year to receive', 'Bronchiectasis']","['Brensocatib (INS1007', 'placebo', 'placebo, 10 mg of brensocatib, or 25 mg of brensocatib', 'placebo, 82 to receive 10 mg of brensocatib, and 87 to receive 25 mg of brensocatib']","['adjusted hazard ratio for exacerbation', 'incidence of dental and skin adverse events of special interest', 'activity and quantity of neutrophil serine proteases, including neutrophil elastase', 'incidence-rate ratio', 'rate of exacerbations (secondary end point), sputum neutrophil elastase activity, and safety', 'sputum neutrophil elastase activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0036734', 'cui_str': 'Serine Endopeptidases'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0064833', 'cui_str': 'Leukocyte elastase'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",256.0,0.548532,Brensocatib treatment prolonged the time to the first exacerbation as compared with placebo (P = 0.03 for 10-mg brensocatib vs. placebo; P = 0.04 for 25-mg brensocatib vs. placebo).,"[{'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Haworth', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Metersky', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Loebinger', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Sibila', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': ""O'Donnell"", 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Eugene J', 'Initials': 'EJ', 'LastName': 'Sullivan', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Mange', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fernandez', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Daley', 'Affiliation': ""From the Division of Molecular and Clinical Medicine, Ninewells Hospital and Medical School, Dundee (J.D.C.), Royal Papworth Hospital NHS Foundation Trust and Department of Medicine, University of Cambridge, Cambridge (C.S.H.), and Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London (M.R.L.) - all in the United Kingdom; the University of Connecticut School of Medicine, Farmington (M.L.M.); the Internal Medicine Department, Respiratory Unit and Adult Cystic Fibrosis Center, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (F.B.); the Department of Pulmonary Medicine, Respiratory Institute, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, and University of Barcelona, Barcelona (O.S.); the Division of Pulmonary, Critical Care, and Sleep Medicine, Georgetown University Medical Center, Washington, DC (A.E.O.); Insmed, Bridgewater, NJ (E.J.S., K.C.M., C.F., J.Z.); and the Department of Medicine, National Jewish Health and the University of Colorado, Denver (C.L.D.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2021713']
1924,32918519,Shared spiritual beliefs between adolescents with cancer and their families.,"BACKGROUND
FAmily CEntered (FACE) Advance Care Planning helps family decision makers to understand and honor patients' preferences for future health care, if patients cannot communicate. Spiritual well-being is a key domain of pediatric oncology care and an integral dimension of pediatric advance care planning.
PROCEDURE
As part of four-site randomized controlled trial of FACE for teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads. The prevalence-adjusted and bias-adjusted kappa (PABAK) measured congruence on FACIT-Sp-EX-4.
RESULTS
Adolescents (126) had mean age of 16.9 years, were 57% female and 79% White. Religious/spiritual classifications were: Catholic (n = 18), Protestant (n = 76), Mormon (n = 3), none/atheist (n = 22), other (n = 5), and unknown (n = 2). Agreement at item level between spiritual well-being of adolescents and families was assessed. Three items had ≥90% agreement and Excellent PABAK: ""I have a reason for living,"" ""I feel loved,"" ""I feel compassion for others in the difficulties they are facing."" Three items had <61% agreement and Poor PABAK: ""I feel a sense of harmony within myself,"" ""My illness has strengthened my faith or spiritual beliefs,"" ""I feel connected to a higher power (or God)."" Dyadic congruence was compared by social-demographics using median one-way analysis. Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
CONCLUSIONS
Family members may not share spiritual beliefs with adolescents and may be unaware of the importance of spiritual well-being for adolescents.",2020,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","['teens with cancer, the functional assessment of chronic illness therapy-spiritual well-being- version 4 (FACIT-Sp-EX-4) was completed independently by 126 adolescents with cancer/family dyads', 'adolescents with cancer and their families', 'Adolescents (126) had mean age of 16.9\xa0years, were 57% female and 79% White']","['FAmily CEntered (FACE', 'FACE']","['Dyadic congruence', 'prevalence-adjusted and bias-adjusted kappa (PABAK']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}]",126.0,0.0242359,"Male family members (median = 72%) were less likely to share spiritual beliefs with their adolescent than female family members (median = 83%), P = .0194.
","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Livingston', 'Affiliation': 'Grant Thornton LLP, Arlington, Virginia.'}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': 'Strategic Innovative Solutions LLC, Petersburg, Florida.'}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Research at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tweddle', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friebert', 'Affiliation': ""Haslinger Family Pediatric Palliative Care Center, Akron Children's Hospital, Akron, Ohio.""}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Baker', 'Affiliation': ""Department of Oncology and Division of Quality of Life and Palliative Care, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Thompkins', 'Affiliation': ""Center for Translational Research/Children's National Research Institute at Children's National Hospital, Washington, District of Columbia.""}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, District of Columbia.'}]",Pediatric blood & cancer,['10.1002/pbc.28696']
1925,32917645,Inflammation Modulation by Vitamin D and Calcium in the Morphologically Normal Colorectal Mucosa of Patients with Colorectal Adenoma in a Clinical Trial.,"Increased COX-2 and decreased 15-hydroxyprostaglandin dehydrogenase (15-HPGD) expression promote prostaglandin-mediated inflammation and colorectal carcinogenesis. Experimental studies suggest that vitamin D and calcium may inhibit these pathways, but their effects on colorectal tissue COX-2 and 15-HPGD expression in humans are unknown. We tested the effects of supplemental vitamin D (1,000 IU/day) and/or calcium (1,200 mg/day) on COX-2 and 15-HPGD expression in the morphologically normal rectal mucosa from 62 paients with colorectal adenoma in a placebo-controlled chemoprevention trial. We measured biomarker expression using automated IHC and quantitative image analysis at baseline and 1-year follow-up, and assessed treatment effects using mixed linear models. The primary outcome was the COX-2/15-HPGD expression ratio, because these enzymes function as physiologic antagonists. After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group ( P = 0.001), 46% in the calcium group ( P = 0.002), and 34% in the calcium + vitamin D group ( P = 0.03), relative to the placebo group. Among individuals with the functional vitamin D-binding protein isoform DBP2 ( GC rs4588*A), the COX-2/15-HPDG ratio decreased 70% ( P = 0.0006), 75% ( P = 0.0002), and 60% ( P = 0.006) in the vitamin D, calcium, and combined supplementation groups, respectively, relative to placebo. These results show that vitamin D and calcium favorably modulate the balance of expression of COX-2 and 15-HPGD-biomarkers of inflammation that are strongly linked to colorectal carcinogenesis-in the normal-appearing colorectal mucosa of patients with colorectal adenoma (perhaps especially those with the DBP2 isoform). PREVENTION RELEVANCE: Supplemental calcium and vitamin D reduce indicators of cancer-promoting inflammation in normal colorectal tissue in humans, thus furthering our understanding of how they may help prevent colorectal cancer.",2020,"After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group (P = 0.001), 46% in the calcium group (P = 0.002), and 34% in the calcium + vitamin D group (P = 0.03), relative to the placebo group.",['62 colorectal adenoma patients in a placebo-controlled chemoprevention trial'],"['vitamin D', 'Vitamin D and Calcium', 'calcium + vitamin D', 'vitamin D and calcium', 'supplemental vitamin D (1,000 I.U./day) and/or calcium']","['Increased cyclooxygenase-2 (COX-2) and decreased 15-hydroxyprostaglandin dehydrogenase (15-HPGD) expression promote prostaglandin-mediated inflammation and colorectal carcinogenesis', 'COX-2 and 15-HPGD expression', 'COX-2/15-HPGD expression ratio, since these enzymes function as physiologic antagonists', 'COX-2/15-HPDG ratio', 'balance of expression of COX-2 and 15-HPGD-biomarkers of inflammation', 'mean COX-2/15-HPGD expression ratio in full-length crypts']","[{'cui': 'C1302401', 'cui_str': 'Adenoma of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0387583', 'cui_str': 'Cyclooxygenase 2'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0044894', 'cui_str': '15-hydroxyprostaglandin dehydrogenase (NAD^+^)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0596263', 'cui_str': 'Oncogenesis'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0020390', 'cui_str': 'Hydroxyprostaglandin Dehydrogenase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",,0.138362,"After 1 year of treatment, the mean COX-2/15-HPGD expression ratio in full-length crypts proportionately decreased 47% in the vitamin D group (P = 0.001), 46% in the calcium group (P = 0.002), and 34% in the calcium + vitamin D group (P = 0.03), relative to the placebo group.","[{'ForeName': 'David Corley', 'Initials': 'DC', 'LastName': 'Gibbs', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Fedirko', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'W Dana', 'Initials': 'WD', 'LastName': 'Flanders', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Marjorie L', 'Initials': 'ML', 'LastName': 'McCullough', 'Affiliation': 'American Cancer Society, Atlanta, Georgia.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Yacoub', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Tapasya', 'Initials': 'T', 'LastName': 'Raavi', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Rutherford', 'Affiliation': 'Division of Digestive Diseases, Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'March E', 'Initials': 'ME', 'LastName': 'Seabrook', 'Affiliation': 'Consultants in Gastroenterology, West Columbia, South Carolina.'}, {'ForeName': 'Roberd M', 'Initials': 'RM', 'LastName': 'Bostick', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia. rmbosti@emory.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0140']
1926,32920777,"Correction to: Corneal Epithelial Findings in Patients with Multiple Myeloma Treated with Antibody-Drug Conjugate Belantamab Mafodotin in the Pivotal, Randomized, DREAMM-2 Study.","The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.",2020,"The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.",['Patients with Multiple Myeloma'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}]",[],[],,0.0225663,"The authors of the above mentioned article would like to highlight the following corrections, based upon recent changes to the FDA label and guidance on the use of belamaf.","[{'ForeName': 'Asim V', 'Initials': 'AV', 'LastName': 'Farooq', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA. afarooq@bsd.uchicago.edu.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Degli Esposti', 'Affiliation': 'NIHR Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust, UCL Institute of Ophthalmology, London, UK.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Popat', 'Affiliation': 'University College London Hospitals, NHS Foundation Trust, London, UK.'}, {'ForeName': 'Praneetha', 'Initials': 'P', 'LastName': 'Thulasi', 'Affiliation': 'Emory Eye Center, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Emory University, Winship Cancer Institute, Atlanta, GA, USA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Zaugg', 'Affiliation': 'Moran Eye Center, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Ashraf Z', 'Initials': 'AZ', 'LastName': 'Badros', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bennie H', 'Initials': 'BH', 'LastName': 'Jeng', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Callander', 'Affiliation': 'University of Wisconsin, Carbone Cancer Center, Madison, WI, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Opalinska', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'January', 'Initials': 'J', 'LastName': 'Baron', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Piontek', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gupta', 'Affiliation': 'GlaxoSmithKline, Upper Providence, PA, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Colby', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00289-z']
1927,32921505,Using a patient prompt list to raise concerns in oncology clinics does not necessarily lead to longer consultations.,"Head and neck oncology post-treatment consultations form a critical component of care in terms of support and surveillance. They occur frequently in the first few years and can place substantial demands on healthcare resources. However, they provide useful opportunities for patients to raise issues and receive tailored information and support. The aim of this paper was to assess whether completion of a 56-item patient prompt list (PCI - the Patient Concerns Inventory) immediately prior to the consultation significantly increased its duration. This was a pragmatic cluster preference randomised controlled trial of 288 patients with 15 consultant clusters from two sites ""using"" (n=8) or ""not using"" (n=7) the PCI. Consultation times were known for 283 patients (136 PCI, 147 non-PCI) who attended their first post-treatment trial consultation a median (IQR) of 103 (70-160) days after the end of treatment. Consultations lasted a median (IQR) of 10 (7-13) minutes (mean 11) in non-PCI patients and a median (IQR) of 11 (8-15) minutes (mean 12) in PCI patients (p=0.07). After adjustment for patient clustering and significant case mix, the 95% confidence interval for the mean difference was between 1.45minutes shorter with the PCI and 2.98minutes longer (p=0.50). There was significant variation in duration by consultant, tumour stage, treatment mode, overall quality of life (QoL), and distress (all p<0.001). In those who completed the PCI, duration increased with the total number of items selected (p<0.001). In conclusion, the inclusion of a prompt list to help facilitate conversation with patients did not make a substantial difference to consultation times.",2020,"In those who completed the PCI, duration increased with the total number of items selected (p<0.001).","['288 patients with 15 consultant clusters from two sites ""using"" (n=8) or ""not using"" (n=7) the PCI']",[],"['duration by consultant, tumour stage, treatment mode, overall quality of life (QoL), and distress']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",288.0,0.148831,"In those who completed the PCI, duration increased with the total number of items selected (p<0.001).","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Faculty of Health and Social Care, Edge Hill University, Ormskirk, L39 4QP; Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK. Electronic address: SIMONN.ROGERS@liverpoolft.nhs.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Semple', 'Affiliation': 'Institute of Nursing and Health Research, Ulster University, Shore Road, Newtownabbey, Co. Antrim, BT37 0QB; South Eastern Health & Social Care, Upper Newtownards Road, Belfast, BT16 1RH. Electronic address: cherith.semple@setrust.hscni.net.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': 'School of Medicine, Medical & Biological Sciences, North Haugh, St Andrews, UK. Electronic address: gmh4@st-andrews.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Astraglobe Ltd., Congleton, Cheshire. Electronic address: astraglobeltd@btconnect.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanatas', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK. Electronic address: anastasios.kanatas@nhs.net.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.08.035']
1928,32924312,Composite restorations placed in non-carious cervical lesions-Which cavity preparation is clinically reliable?,"The purpose of this in-vivo study was to evaluate the clinical performance of restorations placed in non-carious cervical lesions (NCCLs), using different cavity preparation designs, after 7.7 years. A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin were randomly assigned to the following treatment protocols: dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite. After enamel beveling and selective enamel etching, the defects were restored with composite. The restorations were assessed by two independent, calibrated and blinded investigators, using modified USPHS criteria. At 7 years (7.7 (± 0.35)), a total of 64 restorations (75.3%) were available for follow-up examination. The total retention rate, irrespective of the test groups, was 82.8%. Restorations placed without any preparation showed the highest loss rate (27.8%). Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups. Composites are long-term stable materials for restoring NCCLs. Restorations placed without any dentin preparation (cavity cleaning only) showed the highest loss rate.",2020,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.",['A total of 85 NCCLs with coronal margins in enamel and cervical margins in dentin'],"['dentin surface cleaning, dentin surface roughening with round bur plus flowable composite, dentin surface roughening/cervical groove preparation with round bur, dentin surface roughening/cervical groove preparation with round bur plus flowable composite']","['total retention rate', 'Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration', 'highest loss rate']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4274086', 'cui_str': 'Non carious lesion at cervical margin of tooth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0700351', 'cui_str': 'Bur'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0673997', 'cui_str': 'flowable hybrid composite'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0205250', 'cui_str': 'High'}]",85.0,0.0489112,"Esthetic appearance, marginal adaptation, anatomic form and marginal discoloration did not differ significantly between the groups.","[{'ForeName': 'Anne-Katrin', 'Initials': 'AK', 'LastName': 'Lührs', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Jacker-Guhr', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hüsamettin', 'Initials': 'H', 'LastName': 'Günay', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Herrmann', 'Affiliation': 'Department of Conservative Dentistry, Periodontology and Preventive Dentistry, Hannover Medical School, Hannover, Germany.'}]",Clinical and experimental dental research,['10.1002/cre2.310']
1929,32928616,Hostility and aggressive behaviour in first episode psychosis: Results from the OPTiMiSE trial.,"AIM
The aim of this paper is to determine clinical factors related to hostility and disturbing and aggressive behaviour and to examine the effect of medication on these behaviours in FEP.
METHODS
Data from phase I and II of the OPTiMiSE trial are used. Outcome measures are the hostility item of the Positive and Negative Syndrome Scale (PANSS P7) and the disturbing and aggressive behaviour domain of the Personal and Social Performance scale (PSP-D).
RESULTS
Moderate, severe or extreme hostility (PANSS P7 > 3) was present in 42 patients (9.4%). The PANSS P7 and PSP-D were low to moderate but significantly associated with the selected PANSS items: delusions, hallucinatory behaviour, excitement, tension, uncooperativeness, unusual thought content, impulsivity, and lack of judgement and insight. In a subsample of 185 patients (41.5%) with baseline PANSS P7 > 1, the PANSS P7 and PSP-D scores improved in the first 4 weeks of amisulpride treatment. This effect remained significant after controlling for baseline positive symptoms (PANSS P1-P6). No significant differences were found between olanzapine and amisulpride in the second phase of the trial.
CONCLUSION
Clinical risk factors such as poor impulse control, uncooperativeness and excitement could help clinicians in detecting and treating hostile and aggressive behaviour in FEP. Amisulpride could be an effective antipsychotic choice in the treatment of FEP patients who express hostile or aggressive behaviour. Future research is needed to compare the effects of amisulpride and olanzapine on hostility in FEP during the first weeks of treatment.",2020,"No significant differences were found between olanzapine and amisulpride in the second phase of the trial.
","['first episode psychosis', 'FEP patients who express hostile or aggressive behaviour']","['amisulpride', 'olanzapine', 'Amisulpride', 'amisulpride and olanzapine']","['PANSS P7 and PSP-D', 'PANSS P7 and PSP-D scores', 'Hostility and aggressive behaviour', 'severe or extreme hostility', 'hostility item of the Positive and Negative Syndrome Scale (PANSS P7) and the disturbing and aggressive behaviour domain of the Personal and Social Performance scale (PSP-D']","[{'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}]","[{'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",185.0,0.0216339,"No significant differences were found between olanzapine and amisulpride in the second phase of the trial.
","[{'ForeName': 'Margo D M', 'Initials': 'MDM', 'LastName': 'Faay', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: m.d.m.faay@umcutrecht.nl.'}, {'ForeName': 'G Caroline M', 'Initials': 'GCM', 'LastName': 'van Baal', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Arango', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Covadonga M', 'Initials': 'CM', 'LastName': 'Díaz-Caneja', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERSAM, School of Medicine, Universidad Complutense, Madrid, Spain.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Berger', 'Affiliation': 'University Hospital of Psychiatry Zurich, Department of Child and Adolescent Psychiatry and Psychotherapy, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Leucht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Bobes', 'Affiliation': 'Department of Medicine-Psychiatry, University of Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), INEUROPA, CIBERSAM, Oviedo, Spain.'}, {'ForeName': 'Pilar A', 'Initials': 'PA', 'LastName': 'Sáiz', 'Affiliation': 'Department of Medicine-Psychiatry, University of Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), INEUROPA, CIBERSAM, Oviedo, Spain.'}, {'ForeName': 'María Paz', 'Initials': 'MP', 'LastName': 'García-Portilla', 'Affiliation': 'Department of Medicine-Psychiatry, University of Oviedo, Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), INEUROPA, CIBERSAM, Oviedo, Spain.'}, {'ForeName': 'Resy', 'Initials': 'R', 'LastName': 'van de Brug', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Petter', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Winter-van Rossum', 'Affiliation': 'Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Iris E', 'Initials': 'IE', 'LastName': 'Sommer', 'Affiliation': 'Department of Neuroscience, University Medical Center Groningen, Deusinglaan 2, Groningen, the Netherlands; Department of Medical and Biological Psychology, University of Bergen, Norway.'}]",Schizophrenia research,['10.1016/j.schres.2020.08.021']
1930,32925119,Sensor-based technology for upper limb rehabilitation in patients with multiple sclerosis: A randomized controlled trial.,"BACKGROUND
Sensor-based technological therapy devices may be good candidates for neuromotor rehabilitation of people with Multiple Sclerosis (MS), especially for treating upper extremities function limitations. The sensor-based device rehabilitation is characterized by interactive therapy games with audio-visual feedback that allows training the movement of shoulders, elbows, and wrist, measuring the strength and the active range of motion of upper limb, registering data in an electronic database to quantitatively monitoring measures and therapy progress.
OBJECTIVE
This study aimed to investigate the effects of sensor-based motor rehabilitation in add-on to the conventional neurorehabilitation, on increasing the upper limb functions of patients with MS.
METHODS
Thirty patients were enrolled in the study and randomly assigned to the experimental group and the control group. The training consisting of twelve sessions of upper limb training was compared with twelve sessions of upper limb sensory-motor training, without robotic support. Both rehabilitation programs were performed for 40 minutes three times a week, for 4 weeks, in addition to conventional therapy. All patients were evaluated at the baseline (T0) and after 4 weeks of training (T1).
RESULTS
The within-subject analysis showed a statistically significant improvement in both groups, in the Modified Barthel Index and in the Rivermead Mobility Index scores and a significant improvement in Multiple Sclerosis Quality of Life-54 in the experimental. The analysis of effectiveness revealed that, compared with baseline (T0), the improvement percentage in all clinical scale scores was greater in the experimental group than the control group.
CONCLUSIONS
Proposed training provides an intensive and functional-oriented rehabilitation that objectively evaluates achieved progress through exercises. Therefore, it can represent a good complementary strategy for hand rehabilitation in MS patients.",2020,"The within-subject analysis showed a statistically significant improvement in both groups, in the Modified Barthel Index and in the Rivermead Mobility Index scores and a significant improvement in Multiple Sclerosis Quality of Life-54 in the experimental.","['MS patients', 'patients with MS.\nMETHODS\n\n\nThirty patients', 'people with Multiple Sclerosis (MS', 'subjects with multiple sclerosis']","['Sensor-based technology', 'upper limb training was compared with twelve sessions of upper limb sensory-motor training, without robotic support', 'sensor-based motor rehabilitation']","['Multiple Sclerosis Quality of Life-54', 'clinical scale scores', 'Rivermead Mobility Index scores']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0556501', 'cui_str': 'Upper limb training'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",30.0,0.0183361,"The within-subject analysis showed a statistically significant improvement in both groups, in the Modified Barthel Index and in the Rivermead Mobility Index scores and a significant improvement in Multiple Sclerosis Quality of Life-54 in the experimental.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Morone', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'De Angelis', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Casagrande Conti', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Galeoto', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, Piazzale Aldo Moro 5, Rome 00185, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Grasso', 'Affiliation': 'Santa Lucia Foundation, IRCCS, Rome, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201033']
1931,32925256,Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus: comparison of ipsilateral diaphragmatic function: A randomised clinical trial.,"BACKGROUND
The ultrasound-guided retroclavicular block (RCB) is a recently described alternative approach to brachial plexus blockade at the level of the cords. Although more distal blockade of the brachial plexus is thought to be associated with a lower incidence of phrenic nerve block, the impact of RCB on ipsilateral diaphragmatic function has not been formally investigated.
OBJECTIVE
To compare the effects of supraclavicular and retroclavicular brachial plexus block on diaphragmatic function.
SETTING
A single tertiary hospital, study period from December 2017 to May 2019.
DESIGN
Double-blinded, randomised study.
PATIENTS
A total of 40 patients undergoing upper extremity surgery below the axilla. Exclusion criteria included significant pulmonary disease, BMI more than 40 and contra-indication to peripheral nerve block.
INTERVENTIONS
Patients were randomised to supraclavicular or retroclavicular brachial plexus block with ropivacaine 0.5%.
OUTCOME MEASURES
Phrenic block was assessed by measuring changes in diaphragmatic excursion using M-mode ultrasound, and maximum inspiratory volume on incentive spirometry from baseline, at 15 and 30 min postblock, and postoperatively. Comparative assessment of block characteristics included timing and distribution of sensory and motor block onset in the upper extremity, and scanning and block performance times.
RESULTS
The incidence of phrenic block in the supraclavicular group was higher by ultrasound imaging (70 vs. 15%) and also by pulmonary function testing (55 vs. 5%), with both diaphragmatic excursion and maximum inspiratory volume decreasing to a greater extent after supraclavicular block (SCB) compared with RCB at 15, 30 min and postoperative time points (repeated measures analysis of variance, P < 0.001). There was no difference in timing and extent of distal arm block, but suprascapular and axillary nerves were more consistently blocked after SCB than after RCB.
CONCLUSION
The current study confirms the hypothesis that a RCB is significantly less likely to affect ipsilateral diaphragmatic function than a SCB.
TRIAL REGISTRATION
Clinicaltrials.gov identifier: NCT02631122.",2021,"The incidence of phrenic block in the supraclavicular group was higher by ultrasound imaging (70 vs. 15%) and also by pulmonary function testing (55 vs. 5%), with both diaphragmatic excursion and maximum inspiratory volume decreasing to a greater extent after supraclavicular block (SCB) compared with RCB at 15, 30 min and postoperative time points (repeated measures analysis of variance, P < 0.001).","['A total of 40 patients undergoing upper extremity surgery below the axilla', 'A single tertiary hospital, study period from December 2017 to May 2019']","['supraclavicular or retroclavicular brachial plexus block with ropivacaine 0.5', 'ultrasound-guided retroclavicular block (RCB', 'ipsilateral diaphragmatic function', 'Ultrasound-guided supraclavicular vs. retroclavicular block of the brachial plexus', 'supraclavicular and retroclavicular brachial plexus block']","['ipsilateral diaphragmatic function', 'timing and extent of distal arm block, but suprascapular and axillary nerves', 'incidence of phrenic block', 'Phrenic block', 'diaphragmatic excursion and maximum inspiratory volume']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0589496', 'cui_str': 'Supraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006090', 'cui_str': 'Brachial plexus structure'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0228885', 'cui_str': 'Structure of axillary nerve'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0232086', 'cui_str': 'Diaphragmatic excursion'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",40.0,0.221411,"The incidence of phrenic block in the supraclavicular group was higher by ultrasound imaging (70 vs. 15%) and also by pulmonary function testing (55 vs. 5%), with both diaphragmatic excursion and maximum inspiratory volume decreasing to a greater extent after supraclavicular block (SCB) compared with RCB at 15, 30 min and postoperative time points (repeated measures analysis of variance, P < 0.001).","[{'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Georgiadis', 'Affiliation': ''}, {'ForeName': 'Kamen V', 'Initials': 'KV', 'LastName': 'Vlassakov', 'Affiliation': ''}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patton', 'Affiliation': ''}, {'ForeName': 'Philipp B', 'Initials': 'PB', 'LastName': 'Lirk', 'Affiliation': ''}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janfaza', 'Affiliation': ''}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Zeballos', 'Affiliation': ''}, {'ForeName': 'Aurora N', 'Initials': 'AN', 'LastName': 'Quaye', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Schreiber', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001305']
1932,32925621,Mifepristone Combination Therapy Compared With Misoprostol Monotherapy for the Management of Miscarriage: A Cost-Effectiveness Analysis.,"OBJECTIVE
To assess whether mifepristone pretreatment adversely affects the cost of medical management of miscarriage.
METHODS
Decision tree analyses were constructed, and Monte Carlo simulations were run comparing costs of combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone) for medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management. Rates of completed medical evacuation for each were obtained from a recent randomized controlled trial.
RESULTS
In every scenario, combination therapy offered a significant cost advantage over monotherapy. Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage. The cost savings associated with combination therapy were greatest in scenarios using a staged approach to misoprostol administration and in scenarios using in-operating room dilation and curettage as the only modality for uterine evacuation, a savings of $190.20 (99% CI 189.35-191.07) and $217.85 (99% CI 217.19-218.50) per patient in a low-income wage group, respectively. A smaller difference was seen in scenarios using in-office manual vacuum aspiration to complete medical management failures. As patients' wages increased, the difference in cost between combination therapy and monotherapy increased.
CONCLUSION
Mifepristone combined with misoprostol is, overall, more cost effective than monotherapy, and therefore cost should not be a deterrent to its adoption in the management of miscarriage.",2020,"Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage.","['medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management', 'Miscarriage']","['Mifepristone Combination Therapy', 'Mifepristone', 'mifepristone', 'misoprostol', 'Misoprostol Monotherapy', 'combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone']","['cost savings', 'cost of medical management of miscarriage']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",,0.0798285,"Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage.","[{'ForeName': 'Holly H', 'Initials': 'HH', 'LastName': 'Berkley', 'Affiliation': 'Department of Obstetrics & Gynecology at Naval Medical Center San Diego, San Diego, California; and the Uniformed Services University, Bethesda, Maryland.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'Greene', 'Affiliation': ''}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wittenberger', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004063']
1933,32925623,Factors Associated With Serum Estradiol Levels Among Postmenopausal Women Using Hormone Therapy.,"OBJECTIVE
To identify factors associated with serum estradiol (E2) levels among healthy postmenopausal women using hormone therapy (HT).
METHODS
This is an unplanned post hoc analysis of data from ELITE (Early versus Late Intervention Trial with Estradiol), a randomized controlled trial of 1 mg oral E2 with or without vaginal progesterone in healthy early compared with late (<6 years compared with 10 or more years since menopause) postmenopausal women. We included results from visits when women reported at least 80% compliance with HT. Mixed-effects linear models identified factors associated with serum E2 levels while participants were taking HT, assessed every 6 months over a median follow-up of 4.8 years and adjusted for baseline E2 level, visit, and reduced E2 dose. Possible correlates evaluated included demographics, clinical characteristics, medication use, and biomarkers of liver and kidney metabolic function.
RESULTS
The analysis included 2,160 E2 measurements in 275 postmenopausal women. Mean±SD age was 55.4±3.9 vs 64.4±5.5 years, and mean±SD time since menopause was 3.6±1.8 vs 16.0±5.6 years for early vs late postmenopausal women. Adjusted for pretreatment E2 level, visit, and reduced dose indicator, higher serum E2 levels were associated with higher body mass index (BMI), higher weight, surgical menopause, alcohol use, and antihypertensive medication use. Current and past smoking and antifungal medication use were associated with lower serum E2 levels. In the multivariable model, higher BMI and alcohol use were associated with higher serum E2 levels, whereas current and past smoking were associated with lower serum E2 levels. These factors were similar between early and late postmenopausal women.
CONCLUSION
Factors associated with serum E2 levels among postmenopausal women taking HT include BMI, alcohol use, and smoking. As serum E2 levels relate to HT effect, achievement of desirable E2 levels may be maximized through personalized intervention.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT00114517.",2020,Current and past smoking and antifungal medication use were associated with lower serum E2 levels.,"['Postmenopausal Women', 'healthy postmenopausal women using hormone therapy (HT', 'healthy early compared with late (<6 years compared with 10 or more years since menopause) postmenopausal women', '275 postmenopausal women', 'Mean±SD age was 55.4±3.9 vs 64.4±5.5 years, and mean±SD time since menopause was 3.6±1.8 vs 16.0±5.6 years for early vs late postmenopausal women']","['oral E2 with or without vaginal progesterone', 'Estradiol']","['body mass index (BMI), higher weight, surgical menopause, alcohol use, and antihypertensive medication use', 'Serum Estradiol Levels', 'serum E2 levels', 'demographics, clinical characteristics, medication use, and biomarkers of liver and kidney metabolic function', 'serum estradiol (E2) levels']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0948775', 'cui_str': 'High weight'}, {'cui': 'C0740421', 'cui_str': 'Postsurgical menopause'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",275.0,0.0428492,Current and past smoking and antifungal medication use were associated with lower serum E2 levels.,"[{'ForeName': 'Intira', 'Initials': 'I', 'LastName': 'Sriprasert', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Thailand; and the Department of Preventive Medicine, the Department of Medicine, the Atherosclerosis Research Unit, and the Department of Obstetrics and Gynecology, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kono', 'Affiliation': ''}, {'ForeName': 'Roksana', 'Initials': 'R', 'LastName': 'Karim', 'Affiliation': ''}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': ''}, {'ForeName': 'Frank Z', 'Initials': 'FZ', 'LastName': 'Stanczyk', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Shoupe', 'Affiliation': ''}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004006']
1934,32926823,"In AF with recent ACS or PCI, apixaban improved 30-day outcomes vs. VKAs; aspirin effects varied vs. placebo.","SOURCE CITATION
Alexander JH, Wojdyla D, Vora AN, et al. Risk/benefit tradeoff of antithrombotic therapy in patients with atrial fibrillation early and late after an acute coronary syndrome or percutaneous coronary intervention: insights from AUGUSTUS. Circulation. 2020;141:1618-27. 32223444.",2020,"SOURCE CITATION
Alexander JH, Wojdyla D, Vora AN, et al. ",['patients with atrial fibrillation early and late after an acute coronary syndrome or percutaneous coronary intervention'],"['placebo', 'antithrombotic therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0327559,"SOURCE CITATION
Alexander JH, Wojdyla D, Vora AN, et al. ","[{'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Hoffer', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA (E.P.H.).'}]",Annals of internal medicine,['10.7326/ACPJ202009150-029']
1935,32926825,"In older patients with NSTE-ACS, clopidogrel safely reduced bleeding compared with ticagrelor at 1 year.","SOURCE CITATION
Gimbel M, Qaderdan K, Willemsen L, et al. Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. Lancet. 2020;395:1374-81. 32334703.",2020,"Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. ","['patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE', 'older patients with NSTE-ACS']","['clopidogrel', 'Clopidogrel versus ticagrelor or prasugrel']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]",[],,0.0497171,"Clopidogrel versus ticagrelor or prasugrel in patients aged 70 years or older with non-ST-elevation acute coronary syndrome (POPular AGE): the randomised, open-label, non-inferiority trial. ","[{'ForeName': 'Michelle D', 'Initials': 'MD', 'LastName': 'Kelsey', 'Affiliation': 'Division of Cardiology, Duke University, Durham, North Carolina, USA (M.K., L.K.N.).'}, {'ForeName': 'L Kristin', 'Initials': 'LK', 'LastName': 'Newby', 'Affiliation': 'Division of Cardiology, Duke University, Durham, North Carolina, USA (M.K., L.K.N.).'}]",Annals of internal medicine,['10.7326/ACPJ202009150-028']
1936,32927269,The effect of remote patient monitoring on the primary care clinic visit frequency among adults with type 2 diabetes.,"AIMS
Healthcare organizations are increasingly using technology to assist in diabetes management based on telemedicine's proven ability to improve glycemic regulation, decrease cost, and overcome barriers to effective healthcare. Nevertheless, it remains unclear how telemedicine intersects with primary care. We aim to measure the impact of a remote monitoring program for diabetes on primary care delivery through analysis of primary care office visit frequency.
METHODS
Patients eligible to participate in our institution's remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care""). The number of scheduled and completed primary care office visits in the 12 months prior to and after the index date were measured for both groups. The index date was the enrollment date or, for the patients who received usual care, the next available enrollment session after eligibility screen. Two-sample t-tests were used to examine the change in frequency of office visits prior to and after enrollment for participants, as well as the difference in visit frequency between enrolled patients versus patients receiving usual care.
RESULTS
There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth. Furthermore, there was no difference in the number of scheduled or completed primary care visits between patients enrolled in telehealth versus those receiving usual care.
CONCLUSION
Participation in telehealth has been shown to be associated with significant HbA1c reductions in prior work, yet our data suggest that remote monitoring is not associated with a change in primary care office visit frequency. This suggests that telehealth may improve diabetes management independently of primary care visits.",2020,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"['adults with type 2 diabetes', 'Patients eligible to participate in our institution\'s remote diabetes monitoring program were identified and classified as enrolled or not enrolled (i.e. ""usual care']","['remote monitoring program', 'remote patient monitoring']",['number of scheduled or completed primary care clinic visits'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0422587', 'cui_str': 'Diabetes monitoring check done'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}]",,0.0160126,There was no statistical difference in the number of scheduled or completed primary care clinic visits before or after enrollment in telehealth.,"[{'ForeName': 'Morgan Hampton', 'Initials': 'MH', 'LastName': 'Randall', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Zachary Merle', 'Initials': 'ZM', 'LastName': 'Haulsee', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA; Section of Health Systems Research and Policy, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'William Patrick', 'Initials': 'WP', 'LastName': 'Moran', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth Barnhardt', 'Initials': 'EB', 'LastName': 'Kirkland', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kirklane@musc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104267']
1937,32868525,Optimal Criteria for G3 (Poorly Differentiated) Stage II Colon Cancer: Prospective Validation in a Randomized Controlled Study (SACURA Trial).,"Grade 3 (G3, poorly differentiated) is an important treatment-decision factor in stage II colon cancer, but no unified diagnostic criteria are established. According to previous studies, an intratumoural poorly differentiated area with no glandular formation (POR) that fills the microscopic field of a ×40 objective lens was an essential factor that defined G3. We aimed to prospectively validate this in a randomized controlled study of adjuvant chemotherapy (SACURA trial). We enrolled 991 patients with stage II colon cancer. POR was graded according to the ×40 objective lens rule and the intensity of poorly differentiated clusters (Grade), and its prognostic power was compared with that of the conventional tumor grade on the basis of predominant histology rule (Grade). According to Grade, 313, 526, and 152 tumors were classified as G1, G2, and G3, respectively, and the 5-year relapse-free survival (RFS) rates were 91.1%, 82.9%, and 74.7%, respectively (P<0.0001). When G3 and G3 were alternatively added to the prognostic model consisting of 8 conventional factors, only G3 was a significant factor for RFS (P=0.040, Wald test). The adverse impact of G3 on RFS was greater in the microsatellite stable/microsatellite instability-low subset than that in the full analysis set. In the microsatellite stable/microsatellite instability-low subset, the 5-year RFS rate of patients with G3 tumors in the chemotherapy group achieved greater improvement (9.1%) than the surgery-alone group. The least differentiation policy with the ×40 objective lens rule may be highlighted as the diagnostic criterion for G3 because of its validated prognostic value.",2020,The adverse impact of G3 on RFS was greater in the microsatellite stable/microsatellite instability-low subset than that in the full analysis set.,"['Optimal Criteria for G3 (Poorly Differentiated) Stage II Colon Cancer', '991 patients with stage II colon cancer']",['adjuvant chemotherapy'],"['5-year RFS rate', 'POR', '5-year relapse-free survival (RFS) rates', 'adverse impact of G3 on RFS']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0376250', 'cui_str': 'Portuguese language'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",991.0,0.106548,The adverse impact of G3 on RFS was greater in the microsatellite stable/microsatellite instability-low subset than that in the full analysis set.,"[{'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ueno', 'Affiliation': 'Departments of Surgery.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Ishiguro', 'Affiliation': 'Departments of Translational Oncology.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Nakatani', 'Affiliation': 'Division of Statistical Analysis of Research Support Center, Shizuoka General Hospital, Shizuoka.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Specialized Surgeries, Tokyo Medical and Dental University.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Specialized Surgeries, Tokyo Medical and Dental University.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, Nagoya University, Aichi.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Teramukai', 'Affiliation': 'Department of Biostatistics, Kyoto Prefectural University of Medicine, Kyoto.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Murotani', 'Affiliation': 'Biostatistics Center, Kurume University, Graduate School of Medicine.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Ajioka', 'Affiliation': 'Division of Molecular and Diagnostic Pathology, Graduate School of Medical and Dental Sciences, Niigata University, Niigata.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Shimazaki', 'Affiliation': 'Pathology, National Defense Medical College, Saitama.'}, {'ForeName': 'Atsuyuki', 'Initials': 'A', 'LastName': 'Maeda', 'Affiliation': 'Department of Surgery, Ogaki Municipal Hospital, Gifu.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Takuma', 'Affiliation': 'Department of Surgery, Tokyo Metropolitan Tama Medical Center.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgery, Social Insurance Tagawa Hospital, Fukuoka.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kambara', 'Affiliation': 'Department of Surgery, Chugoku Central Hospital, Hiroshima.'}, {'ForeName': 'Keiji', 'Initials': 'K', 'LastName': 'Matsuda', 'Affiliation': 'Department of Surgery, Teikyo University School of Medicine, Tokyo.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Takagane', 'Affiliation': 'Department of Surgery, Hakodate Goryokaku Hospital, Hokkaido, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Department of Surgery, Division of Lower GI Surgery, Hyogo College of Medicine, Hyogo.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Tokyo Medical and Dental University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of surgical pathology,['10.1097/PAS.0000000000001570']
1938,32870153,Bioequivalence of perampanel fine granules and tablets in healthy Japanese subjects.,"OBJECTIVE
Perampanel is an approved anti-seizure drug. A new formulation of perampanel fine granules (FG; 1% perampanel) has been developed for patients who are unable to take tablets. Bioequivalence between the 4-mg FG and tablet perampanel formulations, as well as their safety and tolerability, were assessed.
MATERIALS AND METHODS
In this phase I, single-center, open-label, 2-period, 2-sequence, crossover, bioequivalence study (NCT03399734), healthy Japanese subjects were randomized to receive single doses of the 4-mg FG perampanel and 4-mg perampanel tablet (separated by a ≥ 6-week washout period). Plasma samples for perampanel concentration analysis were collected pre-dose and at intervals up to 168 hours post-dose. The maximum observed concentration (C max ) and area under the concentration-time curve from time zero to 168 hours (AUC (0-168h) ) were used to assess the bioequivalence of the two formulations.
RESULTS
The 90% confidence intervals (CIs) for the geometric mean ratio of test/reference for C max and AUC (0-168h) were within the bioequivalence criteria of 80 - 125% (C max 90% CI 90.8%, 110%; AUC (0-168h) 90% CI 98.2%, 112%; N = 21). 10/24 (41.7%) subjects with FG experienced ≥ 1 treatment-emergent adverse event (TEAE). The events were mild in severity and resolved within 4 hours of onset. There were no deaths, severe TEAEs, serious AEs, or TEAEs leading to study-drug withdrawal.
CONCLUSION
Bioequivalence of 4-mg FG and 4-mg tablet of perampanel was demonstrated. Both perampanel formulations were generally safe and well tolerated. These data suggest that perampanel FG may be a suitable alternative formulation for patients with epilepsy who have difficulties taking perampanel tablets.",2020,"There were no deaths, severe TEAEs, serious AEs, or TEAEs leading to study-drug withdrawal.
","['patients who are unable to take tablets', 'patients with epilepsy who have difficulties taking perampanel tablets', 'healthy Japanese subjects']","['perampanel FG', '4-mg FG perampanel and 4-mg perampanel tablet', 'Perampanel', 'perampanel fine granules and tablets', 'perampanel fine granules (FG; 1%\xa0perampanel', 'perampanel']","['safety and tolerability', 'geometric mean ratio of test/reference for C max and AUC', 'maximum observed concentration (C max ) and area under the concentration-time curve', 'safe and well tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3504760', 'cui_str': 'perampanel Oral Tablet'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C3504760', 'cui_str': 'perampanel Oral Tablet'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0246992,"There were no deaths, severe TEAEs, serious AEs, or TEAEs leading to study-drug withdrawal.
","[{'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Shiba', 'Affiliation': ''}, {'ForeName': 'Hisakuni', 'Initials': 'H', 'LastName': 'Sekino', 'Affiliation': ''}, {'ForeName': 'Kaeko', 'Initials': 'K', 'LastName': 'Ishiba', 'Affiliation': ''}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': ''}, {'ForeName': 'Syuhei', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kotaka', 'Affiliation': ''}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Reyderman', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uchida', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203781']
1939,32870155,A simplified and sensitive LC-APCI-MS/MS method for the quantification of propofol: Application to a bioequivalence study in healthy Chinese subjects.,"OBJECTIVES
Propofol has become the preferred anesthetic in recent years due to its desirable pharmacologic properties. However, propofol possesses a very narrow therapeutic window between the favorable clinical effect and potentially lethal toxicity, therefore, a rapid, simplified, and sensitive liquid chromatography-atmospheric pressure chemical ionization tandem mass spectrometry (LC-APCI-MS/MS) method is presented in this study for the quantification of propofol in human plasma using the isotope-labeled internal standard (IS) of propofol-d17, and then applied in a bioequivalence study.
MATERIALS AND METHODS
Sample preparation was accomplished through simple one-step precipitation of plasma protein with acetonitrile. Chromatographic separation was acquired on an ACE Excel 3 Super C 18 column (2.1 × 50 mm, 3 µm) using gradient elution at a flow rate of 0.5 mL/min. The MS detection was achieved in the negative ion APCI by multiple reaction monitoring (MRM) mode using the transitions of m/z 177.2 → 161.0 for propofol and m/z 194.2 → 174.2 for IS, respectively. 30 healthy Chinese subjects were enrolled in the open-label, randomized, two-period, two-sequence, cross-over bioequivalence study after single-dose intravenous administration of propofol medium-chain triglyceride and long-chain triglyceride (MCT/LCT).
RESULTS
The current method was precise and accurate at a linearity range of 4.00 - 1,000 ng/mL without severe interference from the plasma matrix. The inter- and intra-batch precision (2.3 to 15.8%) and accuracy (-4.4 to 3.0%), IS-normalized matrix effect (coefficient of variation ≤ 4.6%), extraction recovery (107.1 - 117.1%), stability (coefficient of variation ≤ 8.0%), and dilution integrity were all within the acceptable range. The 90% confidence intervals (CIs) of the ratios of the geometric means (test/reference) were 86.44 - 104.88% for C max , 96.30 - 104.52% for AUC 0-t , and 96.56 - 105.05% for AUC 0-∞ , which were all within the predefined bioequivalence range of 80 - 125%. Besides, both propofol MCT/LCT preparations were well tolerated in healthy Chinese subjects, and there were no serious adverse events during the study.
CONCLUSION
The method is more simplified and sensitive than the previously reported modes of propofol detection. The two propofol MCT/LCT preparations were considered to be bioequivalent.",2020,"The inter- and intra-batch precision (2.3 to 15.8%) and accuracy (-4.4 to 3.0%), IS-normalized matrix effect (coefficient of variation ≤ 4.6%), extraction recovery (107.1 - 117.1%), stability (coefficient of variation ≤ 8.0%), and dilution integrity were all within the acceptable range.","['1,000', '30 healthy Chinese subjects', 'healthy Chinese subjects']","['propofol', 'propofol MCT/LCT', 'Propofol', 'propofol medium-chain triglyceride and long-chain triglyceride']","['extraction recovery', 'inter- and intra-batch precision', 'dilution integrity', 'accuracy', 'MS detection']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1564283', 'cui_str': 'Propofol MCT'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0556091', 'cui_str': 'Long chain triglyceride supplementation'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.0205945,"The inter- and intra-batch precision (2.3 to 15.8%) and accuracy (-4.4 to 3.0%), IS-normalized matrix effect (coefficient of variation ≤ 4.6%), extraction recovery (107.1 - 117.1%), stability (coefficient of variation ≤ 8.0%), and dilution integrity were all within the acceptable range.","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'KeLi', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': ''}, {'ForeName': 'XuanWei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203821']
1940,32882517,"Improving abnormal gait patterns by using a gait exercise assist robot (GEAR) in chronic stroke subjects: A randomized, controlled, pilot trial.","BACKGROUND
Although the Gait Exercise Assist Robot (GEAR) has been reported to effectively improve gait of hemiplegic patients, no study has investigated its use in chronic stroke patients. It is possible to facilitate gait reorganization by gait training with less compensation using the GEAR even in chronic stroke patients.
RESEARCH QUESTION
What are the effects of GEAR training on the abnormal gait patterns of chronic stroke subjects?
METHODS
Subjects were randomly assigned to either the GEAR group (n = 8) or the treadmill group (n = 11). Each group underwent 20 sessions (40 min/day, 5 days/week). The changes in the 10 types of abnormal gait patterns were evaluated using a three-dimensional motion analysis system and the Global Rating of Change (GRC) scale before and after the intervention, and at 1-month and 3-month follow-up assessment.
RESULTS
In the GEAR group, hip hiking at a 1-month follow-up assessment was markedly lesser than that before the intervention, and the excessive hip external rotation at 3-month follow-up assessment was notably lesser than that after the intervention, but the change in excessive hip external rotation was in the normal range. In the treadmill group, knee extensor thrust at a 1-month follow-up assessment was strikingly lesser than that before the intervention, but the difference was in the normal range. In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention. But, in the treadmill group, only the GRC scale score at a 1-month follow-up assessment was visibly higher than that before the intervention.
SIGNIFICANCE
Gait training using the GEAR may be more effective than treadmill-training in improving the swing phase in chronic stroke subjects.",2020,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","['chronic stroke patients', 'chronic stroke subjects', 'Subjects']","['GEAR', 'Gait Exercise Assist Robot (GEAR', 'GEAR training', 'gait exercise assist robot (GEAR', 'Gait training']","['excessive hip external rotation', 'hip hiking', 'Global Rating of Change (GRC) scale', 'GRC scale score', 'GRC scale scores']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C4255280', 'cui_str': 'Hiking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0196297,"In the GEAR group, the GRC scale scores were considerably higher after the intervention, at a 1-month, and 3-month follow-up assessment than those before the intervention.","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan. Electronic address: ogino0327@gmail.com.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanata', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Uegaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Tatuya', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Katuhisa', 'Initials': 'K', 'LastName': 'Morisaki', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Shuhei', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Uchiyama', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Japan.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.017']
1941,32888185,Effect of a novel herbal vaginal suppository containing myrtle and oak gall in the treatment of vaginitis: a randomized clinical trial.,"BACKGROUND
Uncomplicated infections such as candidiasis, bacterial vaginosis (BV), or trichomoniasis are easy to diagnose and treat. However, about 8% of patients will have a more complicated course with failure to respond to treatment or rapid recurrence of symptoms. There are many suggestions in Traditional Persian Medicine like myrtle (Myrtus communis L.) and oak gall (Quercus infectoria G.Olivier) for treatment of vaginitis.
OBJECTIVES
A clinical trial was designed to assess the efficacy of a novel herbal suppository, containing myrtle and oak gall (MOGS) in treatment of vaginitis.
METHODS
In a parallel randomized clinical trial, 120 women with vaginitis were randomly assigned to MOGS, metronidazole, or placebo. Formulation was simulated from traditional Persian manuscripts and MGOS was prepared after pharmaceutical optimization processing as well as quantification of gallic acid by HPLC. The study was double-blind for MOGS and placebo and single-blind for metronidazole group.
RESULTS
MOGS effectively improved vaginal discharge (p = 0.024 for BV and 0.018 for trichomoniasis) and pH (compared to placebo (p = 0.013) and metronidazole (p = 0.001)). Both MOGS and metronidazole could reverse whiff test. Metronidazole was the best medication for making Nugent score negative (p = 0.005) as well as the best therapy according to laboratory findings to treat BV in comparison with placebo (p = 0.021). While for trichomoniasis, MOGS could improve the disease more successfully (p = 0.001). Both MOGS and metronidazole treated mixed vaginitis (p = 0.002).
CONCLUSION
MOGS would be a chance for developing new treatment for trichomoniasis.",2020,Metronidazole was the best medication for making Nugent score negative (p = 0.005) as well as the best therapy according to laboratory findings to treat BV in comparison with placebo (p = 0.021).,"['120 women with vaginitis', 'vaginitis']","['Metronidazole', 'metronidazole', 'MOGS, metronidazole, or placebo', 'placebo', 'novel herbal vaginal suppository containing myrtle and oak gall', 'novel herbal suppository, containing myrtle and oak gall (MOGS', 'MOGS and placebo']",['vaginal discharge'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042267', 'cui_str': 'Vaginitis'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C1136199', 'cui_str': 'Vaginal pessary'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1057625', 'cui_str': 'Myrtle'}, {'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}]","[{'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}]",120.0,0.42174,Metronidazole was the best medication for making Nugent score negative (p = 0.005) as well as the best therapy according to laboratory findings to treat BV in comparison with placebo (p = 0.021).,"[{'ForeName': 'Sayyede Fatemeh', 'Initials': 'SF', 'LastName': 'Askari', 'Affiliation': 'Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Bahia Namavar', 'Initials': 'BN', 'LastName': 'Jahromi', 'Affiliation': 'Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amirreza', 'Initials': 'A', 'LastName': 'Dehghanian', 'Affiliation': 'Department of Pathology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Afsoon', 'Initials': 'A', 'LastName': 'Zarei', 'Affiliation': 'Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Tansaz', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parmis', 'Initials': 'P', 'LastName': 'Badr', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Azadi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Abdolali', 'Initials': 'A', 'LastName': 'Mohagheghzadeh', 'Affiliation': 'Department of Phytopharmaceuticals (Traditional Pharmacy), School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran. mohaghegh@sums.ac.ir.'}]","Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences",['10.1007/s40199-020-00365-6']
1942,32894238,Effects of ELDOA and post-facilitation stretching technique on pain and functional performance in patients with piriformis syndrome: A randomized controlled trial.,"BACKGROUND
Piriformis syndrome (PS) is a neuro-muscular condition, which is often underdiagnosed in clinical settings. This study will determine the effects of myofascial stretching Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) and post-facilitation stretching of the piriformis muscle in patients with PS.
OBJECTIVE
We aimed to compare the effects of ELDOA and post-facilitation stretching of the piriformis muscle on pain, muscle length and functional performance in patients with PS.
METHODS
A randomized clinical trial was conducted with 40 PS patients including both males and females, between the ages of 30-70. Patients were randomly assigned to the ELDOA or post-facilitation group after assessments with the Numeric Pain Rating Scale (NPRS), Lower Extremity Functional Scale (LEFS), Piriformis Length Test and Straight Leg Raise (SLR). The assessments were done at baseline and at the end of the sixth week of treatment.
RESULTS
The patients treated with ELDOA demonstrated significant improvement in pain (pre = 7.00 ± 2.75, post = 3.00 ± 1.75), piriformis length (pre = 27.6 ± 5.54, post = 36.8 ± 3.13), SLR (pre = 36.40 ± 7.24, post = 67.5 ± 8.36) and LEFS (pre = 26.90 ± 12.24, post = 58.10 ± 8.62), as compared with the group treated with post-facilitation stretching: pain: pre = 6.00 ± 1.00, post = 2.00 ± 1.50; piriformis length: pre = 28.55 ± 4.03, post = 38.8 ± 2.70; SLR: pre = 40.60 ± 7.48, post = 74.25 ± 5.19, and LEFS: pre = 25.20 ± 7.66, post = 66.30 ± 7.27).
CONCLUSION
It can be concluded that the post-facilitation stretching technique shows more improvement in pain, muscle length, SLR, and LEFS in patients with PS as compared to ELDOA.",2020,"It can be concluded that the post-facilitation stretching technique shows more improvement in pain, muscle length, SLR, and LEFS in patients with PS as compared to ELDOA.","['patients with PS', '40 PS patients including both males and females, between the ages of 30-70', 'patients with piriformis syndrome']","['ELDOA and post-facilitation stretching technique', 'ELDOA', 'myofascial stretching Elongation Longitudinaux Avec Decoaption Osteo Articulaire (ELDOA) and post-facilitation stretching', 'ELDOA and post-facilitation stretching of the piriformis muscle', 'ELDOA or post-facilitation']","['piriformis length', 'pain, muscle length and functional performance', 'pain, muscle length, SLR, and LEFS', 'pain and functional performance', 'Numeric Pain Rating Scale (NPRS), Lower Extremity Functional Scale (LEFS), Piriformis Length Test and Straight Leg Raise (SLR', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458224', 'cui_str': 'Piriformis syndrome'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}]","[{'cui': 'C0224429', 'cui_str': 'Structure of piriformis muscle'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0422926', 'cui_str': 'Straight leg raise test response'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",40.0,0.135265,"It can be concluded that the post-facilitation stretching technique shows more improvement in pain, muscle length, SLR, and LEFS in patients with PS as compared to ELDOA.","[{'ForeName': 'Momena', 'Initials': 'M', 'LastName': 'Shahzad', 'Affiliation': ''}, {'ForeName': 'Nazish', 'Initials': 'N', 'LastName': 'Rafique', 'Affiliation': ''}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Shakil-Ur-Rehman', 'Affiliation': ''}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Ali Hussain', 'Affiliation': ''}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181290']
1943,32892320,Spirulina supplementation improves oxygen uptake in arm cycling exercise.,"PURPOSE
Spirulina has previously been reported to improve high-intensity exercise performance and hemoglobin. However, spirulina's effect on arm cycling exercise has yet to be investigated. The purpose of this study was to investigate the responses of spirulina supplementation on hemoglobin and on oxygen uptake, RER and HR during seated arm cycling exercise.
METHODS
In a double-blinded randomized crossover design, eleven males untrained in arm cycling ingested 6 g/day of spirulina or placebo for seven days. Seated on the Arm Crank Ergometer, each participant performed a baseline V̇O 2max test, and then after supplementation, 2 × 30-min submaximal exercise bouts corresponding to 55% of their V̇O 2max , followed by an incremental test to fatigue. A seven-day wash-out period was required between conditions. Oxygen uptake, RER and HR were measured continuously during exercise and hemoglobin measured prior to exercise after both conditions.
RESULTS
Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9). After spirulina supplementation, during the 30-min exercise bouts, oxygen uptake and HR were significantly lower (2170 ml/min ± 173 Vs 2311 ml/min ± 189 and 154 bpm ± 14 Vs 149 bpm ± 17), RER was not significantly different. In comparison to placebo, Spirulina significantly increased oxygen uptake at time of fatigue (34.10 ml/min/kg ± 6.03 Vs 37.37 ml/min/kg ± 5.98). Time taken to fatigue was not different.
CONCLUSION
Spirulina supplementation significantly reduces oxygen uptake and HR during arm cycling submaximal exercise, allowing for an increased oxygen uptake during an incremental test to fatigue.",2020,"RESULTS
Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9).",['eleven males untrained in arm'],"['placebo', 'Placebo', 'cycling ingested 6\xa0g/day of spirulina or placebo', 'Spirulina supplementation']","['oxygen uptake and HR', 'Oxygen uptake, RER and HR', 'oxygen uptake', 'oxygen uptake at time of fatigue', 'Time taken to fatigue', 'RER', 'hemoglobin and on oxygen uptake, RER and HR']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0075026', 'cui_str': 'Spirulina'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",11.0,0.401488,"RESULTS
Spirulina significantly (p < 0.05) increased Hb in comparison to Placebo (144.1 g/l ± 10.5 Vs 154.5 g/l ± 6.9).","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Gurney', 'Affiliation': 'School of Life Sciences, Kingston University, London, KT1 2EE, UK. T.Gurney@kingston.ac.uk.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Spendiff', 'Affiliation': 'School of Life Sciences, Kingston University, London, KT1 2EE, UK.'}]",European journal of applied physiology,['10.1007/s00421-020-04487-2']
1944,32890782,"Letter to the editor regarding: ""a prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study)"".",,2020,,[],['implantable titanium vertebral augmentation device versus balloon kyphoplasty'],[],[],"[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]",[],,0.0122503,,"[{'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'Levy', 'Affiliation': 'Interventional Radiology, Northside Hospital Atlanta, 1000 Johnson Ferry Rd, Atlanta GA 30342. Electronic address: sjlevy@bellsouth.net.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.08.016']
1945,32896776,The long-term influence of hospital and surgeon volume on local control and survival in the randomized German Rectal Cancer Trial CAO/ARO/AIO-94.,"BACKGROUND
The association of treatment volume and oncological outcome of rectal cancer patients undergoing multidisciplinary treatment is subject of an ongoing debate. Prospective data on long-term local control and overall survival (OS) are not available so far. This study investigated the long-term influence of hospital and surgeon volume on local recurrence (LR) and OS in patients with locally advanced rectal cancers.
METHODS
In a post-hoc analysis of the randomized phase III CAO/ARO/AIO-94 trial after a follow-up of more than 10 years, 799 patients with stage II/III rectal cancers were evaluated. LR-rates and OS were stratified by hospital recruitment volume (≤20 vs. 21-90 vs. >90 patients) and by surgeon volume (≤10 vs. 11-50 vs. >50 procedures).
RESULTS
Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03). The surgeon volume was adversely associated with LR (p = 0.01) but had no influence on overall survival. The positive effect of neoadjuvant chemoradiation (CRT) on local control was the strongest in patients being operated by medium-volume surgeons, less in patients being operated by high-volume surgeons and missing in those being operated by low-volume surgeons.
CONCLUSIONS
Patients with locally advanced rectal cancers might benefit from treatment in specialized high-volume hospitals. In particular, the surgeon volume had significant influence on long-term local tumour control. The effect of neoadjuvant CRT on local tumour control may likewise depend on the surgeon volume.",2020,"RESULTS
Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","['799 patients with stage II/III rectal cancers', 'Patients with locally advanced rectal cancers', 'patients with locally advanced rectal cancers', 'rectal cancer patients undergoing']","['neoadjuvant CRT', 'multidisciplinary treatment', 'neoadjuvant chemoradiation (CRT']","['overall survival (OS', 'LR-rates and OS', 'longer OS', 'long-term local tumour control', 'local control and survival', 'overall survival', 'local recurrence (LR) and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",799.0,0.0971685,"RESULTS
Patients treated in high-volume hospitals had a longer OS than those treated in hospitals with medium or low treatment volume (p = 0.03).","[{'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Sprenger', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany. Electronic address: thilo.sprenger@chiru.med.uni-giessen.de.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Beißbarth', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sauer', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Tschmelitsch', 'Affiliation': 'Department of Surgery, Krankenhaus der Barmherzigen Brüder, St. Veit an der Glan, Austria.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hohenberger', 'Affiliation': 'Department of Surgery, University Medical Center Erlangen, Erlangen, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Staib', 'Affiliation': 'Department of General and Visceral Surgery, Klinikum Esslingen, Esslingen, Germany.'}, {'ForeName': 'Hans-Rudolf', 'Initials': 'HR', 'LastName': 'Raab', 'Affiliation': 'University Department of General and Visceral Surgery, Klinikum Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'Department of Radiotherapy and Oncology, University Medical Center Frankfurt, Frankfurt/Main, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ghadimi', 'Affiliation': 'Department of General, Visceral and Pediatric Surgery, University Medical Center Göttingen, Göttingen, Germany.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.021']
1946,32907801,Two-year cost effectiveness between two gradual tapering strategies in rheumatoid arthritis: cost-utility analysis of the TARA trial.,"OBJECTIVE
The aim of the current study was to evaluate the 2-year cost-utility ratio between tapering conventional synthetic disease-modifying antirheumatic drugs (csDMARD) first followed by the tumour necrosis factor (TNF)-inhibitor, or vice versa, in patients with rheumatoid arthritis (RA).
METHODS
Two-year data of the Tapering strategies in Rheumatoid Arthritis trial were used. Patients with RA, who used both a csDMARD and a TNF-inhibitor and had a well-controlled disease (disease activity score ≤2.4 and swollen joint count≤1) for at least 3 months, were randomised into gradual tapering the csDMARD first followed by the TNF-inhibitor, or vice versa. Quality-adjusted life years (QALYs) were derived from the European Quality of life questionnaire with 5 dimensions. Healthcare and productivity costs were calculated with data from patient records and questionnaires. The incremental cost-effectiveness ratio and the incremental net monetary benefit were used to assess cost effectiveness between both tapering strategies.
RESULTS
94 patients started tapering their TNF-inhibitor first, while the other 95 tapered their csDMARD first. QALYs (SD) were, respectively, 1.64 (0.22) and 1.65 (0.22). Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10). Therefore, total costs (SD) were €38 833 (€39 616) for tapering csDMARDs first, and €39 442 (€47 271) for tapering the TNF-inhibitor (p=0.88). For willingness-to-pay (WTP) levels <€83 800 tapering, the csDMARD first has the highest probability of being cost effective, while for WTP levels >€83 800 tapering the TNF-inhibitor first has the highest probability.
CONCLUSION
Our economic evaluation shows that costs are similar for both tapering strategies. Regardless of the WTP, tapering either the TNF-inhibitor or the csDMARD first is equally cost effective.
TRIAL REGISTRATION NUMBER
NTR2754.",2020,"Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10).","['rheumatoid arthritis', '94 patients started tapering their TNF-inhibitor first, while the other 95 tapered their csDMARD first', 'patients with rheumatoid arthritis (RA', 'Patients with RA, who used both a csDMARD and a TNF-inhibitor and had a well-controlled disease (disease activity score ≤2.4 and swollen joint count≤1) for at least 3 months']",['conventional synthetic disease-modifying antirheumatic drugs (csDMARD'],"['2-year cost-utility ratio', 'productivity loss', 'WTP levels', 'Quality-adjusted life years (QALYs', 'cost effectiveness', 'Medication costs', 'European Quality of life', 'incremental cost-effectiveness ratio', 'total costs (SD', 'Healthcare and productivity costs']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",,0.0243286,"Medication costs were significantly lower in the patients who tapered the TNF-inhibitor first, while indirect cost were higher due to more productivity loss (p=0.10).","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Tjallingius Martijn', 'Initials': 'TM', 'LastName': 'Kuijper', 'Affiliation': 'Rheumatology, Maasstad Hospital, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'N H A M', 'Initials': 'NHAM', 'LastName': 'Denissen', 'Affiliation': 'Rheumatology, Amphia Hospital, Breda, North Brabant, The Netherlands.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Gerards', 'Affiliation': 'Rheumatology, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Mike H', 'Initials': 'MH', 'LastName': 'de Jager', 'Affiliation': 'Rheumatology, Albert Schweitzer Hospital, Dordrecht, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Wai-Kwan', 'Initials': 'WK', 'LastName': 'Lam-Tse', 'Affiliation': 'Rheumatology, Franciscus Gasthuis en Vlietland, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jolanda J', 'Initials': 'JJ', 'LastName': 'Luime', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217528']
1947,32913645,The impact of intuitive eating v . pinned eating on behavioural markers: a preliminary investigation.,"Two promising strategies to manage eating behaviour are intuitive eating (IE; following hunger) and pinned eating (PE; ignoring hunger/eating at specific times of the day). This study compared IE and PE on behavioural markers. Participants ( n 56) were randomly assigned to IE ( n 28) or PE ( n 28) and given instructions to follow for 1 week. Drive to eat, behaviour, behavioural intentions and self-efficacy were measured at baseline and follow-up. Participants also evaluated their specific intervention. Comparable changes over time were found for both conditions for many measures. Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss: those following IE showed an increase in each of these outcomes compared to those following PE who showed no change. The IE group found their intervention more useful than those following PE. Further research is needed to build on these preliminary findings.",2020,"Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss:",['Participants ( n 56'],"['PE', 'intuitive eating v . pinned eating']","['behavioural markers', 'healthy snacking, total self-efficacy and self-efficacy for weight loss', 'Drive to eat, behaviour, behavioural intentions and self-efficacy']",[],"[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",56.0,0.0331015,"Significant conditions by time interactions were found for healthy snacking, total self-efficacy and self-efficacy for weight loss:","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Ogden', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Pavlova', 'Affiliation': 'School of Nutrition, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Hollie', 'Initials': 'H', 'LastName': 'Fouracre', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Lammyman', 'Affiliation': 'School of Psychology, University of Surrey, Guildford GU2 7XH, UK.'}]",Journal of nutritional science,['10.1017/jns.2020.25']
1948,32920032,Is Meatal Analgesia Necessary for Pain Reduction During Cystoscopy in Females? A Prospective Randomized Study.,"OBJECTIVE
To evaluate whether anesthesia of the meatal orifice reduces pain during cystoscopy in women, known to cause significant pain, discomfort and anxiety in women. Secondary end-point was to compare pain between rigid and flexible cystoscopy.
METHODS
A total of 120 women, median age 66 (interquartile range 57-69), referred for office cystoscopy were prospectively randomized into 2 groups according to meatal orifice exposure: (1) 5-minute meatus exposure with 2% lidocaine gel; (2) 5-minute meatal exposure with water soluble gel. In each group a pad soaked by the gel was externally placed on the meatal orifice. Each group was further divided to flexible or rigid cystoscopy. Exclusion criteria included urethral stricture, urinary tract infection, chronic pain disease (e.g., IC/PBS), neurogenic disorder, allergy to lubricant, and concurrent pain medication. In all patients, a water-based lubricant applied on the cystoscope, was used for lubrication. A 0-10 visual analogue scale was performed at 4 checkpoints: before examination, immediately following urethral penetration, immediately at end of procedure and 15 minutes after completion RESULTS: Study groups did not significantly differ in clinical or demographic parameters. Pain level prior to procedure was 0 in all patients. Mean visual analogue scale immediately after urethral penetration was 4.2 ± 2.3 in both groups 1 and 2 (P= 1). No significant differences in other checkpoints was reported. Further subanalysis by cystoscope type did not demonstrate significance.
CONCLUSION
Meatal analgesia does not increase tolerance to cystoscopy in females. Pain level is not reduced by the use of flexible cystoscope in the female population.",2020,Mean VAS immediately after urethral penetration was 4.2±2.3 in both groups 1 and 2 (p=1).,"['women', 'Exclusion criteria included: urethral stricture, urinary tract infection, chronic pain disease (e.g. IC/PBS), neurogenic disorder, allergy to lubricant and concurrent pain medication', 'females', '120 women, median age 66 (IQR 57-69), referred for office cystoscopy']","['flexible or rigid cystoscopy', 'meatal orifice exposure: (1) 5 minute meatus exposure with 2% lidocaine gel; (2) 5 minute meatal exposure with water soluble gel', 'flexible cystoscope']","['Mean VAS', 'pain between rigid and flexible cystoscopy', 'Pain level', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0041974', 'cui_str': 'Urethral stenosis'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0577993', 'cui_str': 'Rigid cystoscopy'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0180275', 'cui_str': 'Flexible cystoscope'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0577992', 'cui_str': 'Flexible cystoscopy'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",120.0,0.0496774,Mean VAS immediately after urethral penetration was 4.2±2.3 in both groups 1 and 2 (p=1).,"[{'ForeName': 'Yishai H', 'Initials': 'YH', 'LastName': 'Rappaport', 'Affiliation': 'Departments of Urology, Shamir Medical Center, Zerifin, Israel. Electronic address: rappaport.urology@gmail.com.'}, {'ForeName': 'Ilia', 'Initials': 'I', 'LastName': 'Beberashvili', 'Affiliation': 'Departments of Nephrology, Sackler School of medicine, Tel Aviv University, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Zisman', 'Affiliation': 'Departments of Urology, Shamir Medical Center, Zerifin, Israel.'}, {'ForeName': 'Kobi', 'Initials': 'K', 'LastName': 'Stav', 'Affiliation': 'Departments of Urology, Shamir Medical Center, Zerifin, Israel.'}]",Urology,['10.1016/j.urology.2020.08.052']
1949,32930855,[Surgical techniques in the treatment of basal cell carcinoma-a prospective investigation].,"BACKGROUND
Basal cell carcinomas are the most frequent epithelial skin tumors and a frequent indication for dermatological interventions. Despite the establishment of drug treatment options, surgery is still the treatment of choice. Various options are available ranging from curettage to complex dermatosurgical procedures. In addition to the main aspect of low local recurrence rates, esthetic factors and the number of procedures are also important for the choice of treatment.
METHODS
In this study 347 patients with 398 basal cell carcinomas (nodular type, diameter up to 10 mm) were prospectively examined. The patients were randomized into two treatment arms: in one group the tumor was treated by ring curettage and in the other group the tumor was excised. Patients who underwent 3D histologically controlled surgery due to basal cell carcinoma during the same investigation period served as controls.
RESULTS
The highest local recurrence rate was observed after curettage (14.0%), whereas the group with 3D histology had the lowest recurrence rate (0.9%, p < 0.001). In the 3D group, more re-excisions were required to achieve complete tumor clearance compared to the group who underwent excisions with serial section histology. Patients rated the esthetic outcome best after curettage. The median follow-up was 3.9 years.
CONCLUSION
The choice of surgical treatment for small nodular basal cell carcinomas depends on individual circumstances. Excisions controlled by 3D histology with wound closure after complete tumor clearance showed the lowest recurrence rate in our study; however, curettage is also a possible surgical treatment option with minimal effort and an acceptable recurrence rate, which can lead to good esthetic results.",2020,"The highest local recurrence rate was observed after curettage (14.0%), whereas the group with 3D histology had the lowest recurrence rate (0.9%, p < 0.001).","['347 patients with 398 basal cell carcinomas (nodular type, diameter up to 10\xa0mm', 'Patients who underwent 3D histologically controlled surgery due to basal cell carcinoma during the same investigation period served as controls', 'small nodular basal cell carcinomas']",[],"['lowest recurrence rate', 'highest local recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007117', 'cui_str': 'Basal cell carcinoma'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1304300', 'cui_str': 'Nodular basal cell carcinoma of skin'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205276', 'cui_str': 'Local'}]",347.0,0.0156459,"The highest local recurrence rate was observed after curettage (14.0%), whereas the group with 3D histology had the lowest recurrence rate (0.9%, p < 0.001).","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Kofler', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Hans-Martin', 'Initials': 'HM', 'LastName': 'Häfner', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland. hans-martin.haefner@med.uni-tuebingen.de.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eichner', 'Affiliation': 'Institut für Klinische Epidemiologie und angewandte Biometrie, Eberhard Karls Universität Tübingen, Silcherstr.\xa05, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kofler', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}, {'ForeName': 'Saskia Maria', 'Initials': 'SM', 'LastName': 'Schnabl', 'Affiliation': ''}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Breuninger', 'Affiliation': 'Universitätshautklinik, Eberhard-Karls Universität Tübingen, Liebermeisterstr.\xa025, 72076, Tübingen, Deutschland.'}]","Der Hautarzt; Zeitschrift fur Dermatologie, Venerologie, und verwandte Gebiete",['10.1007/s00105-020-04685-1']
1950,32925628,Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women.,"OBJECTIVE
To evaluate characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.
METHODS
We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded. A composite of adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage were evaluated. Log binomial regression models estimated relative risks and 95% CIs for associations of outcomes with patient characteristics including randomly assigned treatment group. Interactions between patient characteristics and treatment group were tested.
RESULTS
Of 6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis. Frequency of the perinatal composite was 252 (5.0%), 166 (3.3%) for third- or fourth-degree perineal laceration, and 237 (4.7%) for postpartum hemorrhage. In multivariable analysis, intended labor induction at 39 weeks of gestation was associated with a reduced perinatal composite outcome (4.1% vs 6.0%; adjusted relative risk [aRR] 0.71; 95% CI 0.55-0.90), whereas increasing body mass index (BMI) was associated with an increased perinatal composite outcome (aRR 1.04/unit increase; 95% CI 1.02-1.05). Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60). Increased risk of postpartum hemorrhage was observed in Hispanic women compared with White women (6.3% vs 4.0%; aRR 1.64; 95% CI 1.18-2.29). Patient characteristics associated with adverse outcomes were similar between treatment groups (P for interaction >.05).
CONCLUSION
Compared with expectant management, intended induction at 39 weeks of gestation was associated with reduced risk of adverse perinatal outcome. Patient characteristics associated with adverse outcomes were few and similar between groups.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT01990612.",2020,Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60).,"['low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management', '6,096 women with outcome data, 5,007 (82.1%) met criteria for inclusion in this analysis', 'Low-Risk Nulliparous Women']","['Elective Labor Induction at 39 Weeks of Gestation', 'Expectant Management']","['Decreased risk of third- or fourth-degree perineal laceration', 'BMI', 'Frequency of the perinatal composite', 'body mass index (BMI', 'Increased risk of postpartum hemorrhage', 'perinatal composite outcome', 'adverse outcomes', 'reduced risk of adverse perinatal outcome', 'adverse outcomes (perinatal death or severe neonatal complications), third- or fourth-degree lacerations, and postpartum hemorrhage', 'postpartum hemorrhage']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1275806', 'cui_str': 'Fourth degree perineal laceration'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043246', 'cui_str': 'Laceration'}]",6096.0,0.346142,Decreased risk of third- or fourth-degree perineal laceration was observed with increasing BMI (aRR 0.96/unit increase; 95% CI 0.93-0.98) and in Black women compared with White women (1.2% vs 3.9%; aRR 0.34; 95% CI 0.19-0.60).,"[{'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ""Departments of Obstetrics and Gynecology, Stanford University, Stanford, California, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004055']
1951,32925629,Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.,"OBJECTIVE
To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
METHODS
This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.
RESULTS
From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial. Consent was more likely for Black women (41%, adjusted odds ratio [aOR] 1.47, 95% CI 1.24-1.74), and less likely for Asian women (15%, aOR 0.64, 95% CI 0.48-0.84), compared with White women (24%). Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%). Younger women were also more likely to consent. Among eligible women who declined participation and provided a reason (68%), preference to be expectantly managed (85%) was most common, a response more common in Asian women (aOR 1.75, 95% CI 1.31-2.33) and less common in women without private insurance (aOR 0.60, 95% CI 0.51-0.70). Not wanting to participate in research was more common in Asian women (aOR 2.41, 95% CI 1.44-4.03). Declining consent because family or friends objected was more common in Asian women (aOR 2.51, 95% CI 1.27-4.95) and women without private insurance (aOR 1.68, 95% CI 1.10-2.59).
CONCLUSION
Frequency of consent and reasons for declining consent were associated with age, type of insurance, and race and ethnicity. These findings should be considered when developing recruitment strategies that promote diverse participant representation.
CLINICAL TRIAL REGISTRATION
ClinialTrials.gov, NCT01990612.",2020,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","['low-risk nulliparous women', 'From August 2016 (start of additional data collection) to August 2017, 1,965 (28%) of the 7,112 eligible women consented to the trial', 'Younger women']",[],[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],[],7112.0,0.369739,"Women without private insurance were more likely to consent (38%, aOR 1.55, 95% CI 1.34-1.79), compared with those with private insurance (22%).","[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ""Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.""}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'de Voest', 'Affiliation': ''}, {'ForeName': 'Sabine Z', 'Initials': 'SZ', 'LastName': 'Bousleiman', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Allard', 'Affiliation': ''}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Felecia', 'Initials': 'F', 'LastName': 'Ortiz', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bartholomew', 'Affiliation': ''}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bickus', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003998']
1952,32925634,Customized Probability of Vaginal Delivery With Induction of Labor and Expectant Management in Nulliparous Women at 39 Weeks of Gestation.,"OBJECTIVE
To develop models to predict vaginal delivery in low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation.
METHODS
We conducted a secondary analysis of a randomized controlled trial of planned elective induction of labor at 39 weeks of gestation compared with expectant management for low-risk nulliparous women. Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm). Multivariable logistic regression models were developed for each group using patient characteristics that would be available at the time of counseling. Model selection was based on k-fold cross-validation using backward elimination and variables that remained significant at P<.05 were retained. To compare estimated with observed rates, the elective induction of labor model was then applied to each woman in both groups to estimate individualized predicted probabilities of vaginal delivery with elective induction of labor.
RESULTS
Of 6,106 women enrolled in the trial, 4,661 met criteria for this analysis. Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005). The final elective induction of labor model included age, height, weight, and modified Bishop score (area under the receiver operating characteristic curve [AUROC] 0.72, 95% CI 0.70-0.75). The same variables were included in the final expectant management model (AUROC 0.70, 95% CI 0.67-0.72). Across the range of predicted probability deciles derived from the elective induction of labor model, almost all women who underwent elective induction of labor at 39 weeks of gestation had a higher observed chance of vaginal delivery than expectant management.
CONCLUSION
Irrespective of the individual predicted chance of vaginal delivery from elective induction of labor at 39 weeks of gestation, vaginal delivery is generally more frequent if elective induction of labor is undertaken rather than expectant management. These data can be used to counsel nulliparous women regarding their ""customized"" chances of vaginal delivery as they choose between elective induction of labor or expectant management at 39 weeks of gestation.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT01990612.",2020,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","['Nulliparous Women at 39 Weeks of Gestation', 'counsel nulliparous women', 'low-risk, nulliparous women contemplating elective induction of labor or expectant management at 39 weeks of gestation', 'low-risk nulliparous women', '6,106 women enrolled in the trial', 'Two groups were included for this analysis: 1) women who were randomized to the induction of labor group and underwent elective induction at 39 0/7-39 4/7 weeks of gestation and 2) women who were randomized to the']","['Vaginal Delivery With Induction of Labor and Expectant Management', 'expectant management group who experienced spontaneous labor or medically indicated delivery (including postterm', 'expectant management', 'planned elective induction of labor']","['Vaginal delivery', 'chance of vaginal delivery']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0474461', 'cui_str': 'Spontaneous onset of labor'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]",6106.0,0.0517142,"Vaginal delivery occurred in 80.6% of the 2,153 women in the elective induction of labor group and 77.2% of the 2,508 women in the expectant management group (P=.005).","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ""Departments of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, Utah, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, Stanford University, Stanford, California, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, and Washington University in St. Louis, St. Louis, Missouri; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Madeline Murguia', 'Initials': 'MM', 'LastName': 'Rice', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mallett', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Gibbs', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004046']
1953,32932346,"Effects of Positive End-Expiratory Pressure in ""High Compliance"" Severe Acute Respiratory Syndrome Coronavirus 2 Acute Respiratory Distress Syndrome.","OBJECTIVES
Clinical observation suggests that early acute respiratory distress syndrome induced by the severe acute respiratory syndrome coronavirus 2 may be ""atypical"" due to a discrepancy between a relatively unaffected static respiratory system compliance and a significant hypoxemia. This would imply an ""atypical"" response to the positive end-expiratory pressure.
DESIGN
Single-center, unblinded, crossover study.
SETTING
ICU of Bari Policlinico Academic Hospital (Italy), dedicated to care patients with confirmed diagnosis of novel coronavirus disease 2019.
PATIENTS
Eight patients with early severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome and static respiratory compliance higher than or equal to 50 mL/cm H2O.
INTERVENTIONS
We compared a ""lower"" and a ""higher"" positive end-expiratory pressure approach, respectively, according to the intervention arms of the acute respiratory distress syndrome network and the positive end-expiratory pressure setting in adults with acute respiratory distress syndrome studies.
MEASUREMENTS AND MAIN RESULTS
Patients were ventilated with the acute respiratory distress syndrome network and, subsequently, with the ExPress protocol. After 1 hour of ventilation, for each protocol, we recorded arterial blood gas, respiratory mechanics, alveolar recruitment, and hemodynamic variables. Comparisons were performed with analysis of variance for repeated measures or Friedman test as appropriate. Positive end-expiratory pressure was increased from 9 ± 3.5 to 17.7 ± 1.7 cm H2O (p < 0.01). Alveolar recruitment was 450 ± 111 mL. Static respiratory system compliance decreased from 58.3 ± 7.6 mL/cm H2O to 47.4 ± 14.5 mL/cm H2O (p = 0.018) and the ""stress index"" increased from 0.97 ± 0.03 to 1.22 ± 0.07 (p < 0.001). The PaO2/FIO2 ratio increased from 131 ± 22 to 207 ± 41 (p < 0.001), and the PaCO2 increased from 45.9 ± 12.7 to 49.8 ± 13.2 mm Hg (p < 0.001). The cardiac index went from 3.6 ± 0.4 to 2.9 ± 0.6 L/min/m (p = 0.01).
CONCLUSIONS
Our data suggest that the ""higher"" positive end-expiratory pressure approach in patients with severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome and high compliance improves oxygenation and lung aeration but may result in alveolar hyperinflation and hemodynamic alterations.",2020,"The PaO2/FIO2 ratio increased from 131 ± 22 to 207 ± 41 (p < 0.001), and the PaCO2 increased from 45.9 ± 12.7 to 49.8 ± 13.2 mm Hg (p < 0.001).","['patients with severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome', 'adults with acute respiratory distress syndrome studies', 'High Compliance"" Severe Acute Respiratory Syndrome Coronavirus 2 Acute Respiratory Distress Syndrome', 'ICU of Bari Policlinico Academic Hospital (Italy), dedicated to care patients with confirmed diagnosis of novel coronavirus disease 2019', 'Eight patients with early severe acute respiratory syndrome coronavirus 2 acute respiratory distress syndrome and static respiratory compliance higher than or equal to 50 mL/cm H2O']","['higher"" positive end-expiratory pressure approach', 'Positive End-Expiratory Pressure']","['arterial blood gas, respiratory mechanics, alveolar recruitment, and hemodynamic variables', 'Positive end-expiratory pressure', 'PaCO2', 'PaO2/FIO2 ratio', 'Static respiratory system compliance', 'stress index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1532578', 'cui_str': 'mL/cm H2O'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",8.0,0.145428,"The PaO2/FIO2 ratio increased from 131 ± 22 to 207 ± 41 (p < 0.001), and the PaCO2 increased from 45.9 ± 12.7 to 49.8 ± 13.2 mm Hg (p < 0.001).","[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Grasso', 'Affiliation': '1Dipartimento dell\'Emergenza e Trapianti d\'Organo (DETO), Sezione di Anestesiologia e Rianimazione, Università degli Studi di Bari ""Aldo Moro,"" Bari, Italy. 2Dipartimento di Dipartimento Scienze mediche e chirurgiche, Sezione anestesia e rianimazione, Università degli Studi di Foggia, Foggia, Italy. 3Dipartimento di Morfologia, Chirurgia e Medicina Sperimentale, Sezione di Anestesiologia e Terapia Intensiva Universitaria, Università degli studi di Ferrara, Ferrara, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirabella', 'Affiliation': ''}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Murgolo', 'Affiliation': ''}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Di Mussi', 'Affiliation': ''}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Pisani', 'Affiliation': ''}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Dalfino', 'Affiliation': ''}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': ''}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Rauseo', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lamanna', 'Affiliation': ''}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Cinnella', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004640']
1954,32936680,Effects of sex and menstrual cycle on volume-regulatory responses to 24-h fluid restriction.,"Reproductive hormones have significant nonreproductive physiological effects, including altering fluid regulation. Our purpose was to explore the impact of sex and menstrual cycle (MC) phase on volume-regulatory responses to 24-h fluid restriction (24-h FR). Participants (men: n = 12, 20 ± 2 yr; women: n = 10, 20 ± 1 yr) were assigned two randomized and counterbalanced fluid prescriptions [Euhy: euhydrated, urine specific gravity (USG) < 1.020; Dehy: 24-h FR, USG > 1.020]. Men completed both (MEuhy, MDehy), while women completed both in the late-follicular ( days 10-13 ; FDehy, FEuhy) and midluteal ( days 18-22 ; LDehy, LEuhy) phases. We measured body mass, plasma and urine osmolality (P osm , U osm ), urine specific gravity (USG), urine color (U col ), and serum copeptin; 24-h FR yielded mild dehydration without influence of sex or MC ( P > 0.05). Copeptin increased in men following Dehy (pre: 8.2 ± 5.2, post: 15.8 ± 12.6, P = 0.04) but not in women (FDehy pre: 4.3 ± 1.6, post: 10.5 ± 6.9, P = 0.06; LDehy pre: 5.6 ± 3.5, post: 10.4 ± 6.2, P = 0.16). In FDehy, P osm increased following FR (pre: 288 ± 2, post: 292 ± 1, P = 0.03) but not in men (pre: 292 ± 3, post: 293 ± 2, P = 0.46). No MC differences were observed between body mass loss, P osm , U osm , USG, and copeptin ( P > 0.05). These results suggest that volume-regulatory responses to 24-h FR were present in men but not in women, without apparent effects of the menstrual cycle.",2020,"Men exhibited higher copeptin following Dehy (pre: 8.2±5.2, post: 15.8±12.6, P=0.04) but women did not (FDehy - pre: 4.3±1.6, post: 10.5±6.9, P=0.06; LDehy - pre: 5.6±3.5, post: 10.4±6.2, P=0.16).","['young healthy adults', 'Participants (men: n=12, 20±2y; women: n=10, 20±1y']",['24-hour fluid restriction (24-h FR'],"['body mass, plasma and urine osmolality (P osm , U osm ), USG, urine color (U col ) and serum copeptin', 'BML, P osm , U osm , USG, U col , and serum copeptin']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0204700', 'cui_str': 'Fluid restriction'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0439186', 'cui_str': 'osmol'}, {'cui': 'C0278030', 'cui_str': 'Color of urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",,0.0971306,"Men exhibited higher copeptin following Dehy (pre: 8.2±5.2, post: 15.8±12.6, P=0.04) but women did not (FDehy - pre: 4.3±1.6, post: 10.5±6.9, P=0.06; LDehy - pre: 5.6±3.5, post: 10.4±6.2, P=0.16).","[{'ForeName': 'Gabrielle E W', 'Initials': 'GEW', 'LastName': 'Giersch', 'Affiliation': 'United States Army Research Institute for Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Abigail T', 'Initials': 'AT', 'LastName': 'Colburn', 'Affiliation': 'Arizona State University, Hydration Science Laboratory, Phoenix, Arizona.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Morrissey', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Cody R', 'Initials': 'CR', 'LastName': 'Butler', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Michaela L', 'Initials': 'ML', 'LastName': 'Pruchnicki', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Stavros A', 'Initials': 'SA', 'LastName': 'Kavouras', 'Affiliation': 'Arizona State University, Hydration Science Laboratory, Phoenix, Arizona.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'United States Army Research Institute for Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Casa', 'Affiliation': 'Korey Stringer Institute, Department of Kinesiology, University of Connecticut, Storrs, Connecticut.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00173.2020']
1955,32938569,Final Overall Survival Results from a Phase 3 Study to Compare Tivozanib to Sorafenib as Third- or Fourth-line Therapy in Subjects with Metastatic Renal Cell Carcinoma.,"Tivozanib is a potent and selective inhibitor of the VEGF receptor. In an open-label, randomized phase 3 trial, we compared tivozanib to sorafenib in patients with metastatic renal cell carcinoma (mRCC) who had received two or three prior therapies. We have previously reported that the study met its primary endpoint, demonstrating an improvement in progression-free survival with tivozanib versus sorafenib (5.6 mo vs 3.9 mo; hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.56-0.94; p=0.016). The current report reflects the final assessment of overall survival, showing no difference between treatment with tivozanib and sorafenib (HR 0.97, 95% CI 0.75-1.24). Given its activity and distinct tolerability profile, tivozanib represents a treatment option for patients with previously treated mRCC. PATIENT SUMMARY: We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments. No difference in survival was observed.",2020,"We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments.","['Subjects with Metastatic Renal Cell Carcinoma', 'patients with kidney cancer who have received two or three prior treatments', 'patients with previously treated mRCC', 'patients with metastatic renal cell carcinoma (mRCC) who had received two or three prior therapies']","['Tivozanib to Sorafenib', 'tivozanib versus sorafenib', 'tivozanib', 'tivozanib and sorafenib', 'Tivozanib', 'tivozanib to sorafenib', 'targeted therapy (sorafenib']","['progression-free survival', 'survival', 'overall survival']","[{'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2827667', 'cui_str': 'tivozanib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.141364,"We show that tivozanib, a targeted therapy, can delay tumor growth relative to an already approved targeted therapy (sorafenib) in patients with kidney cancer who have received two or three prior treatments.","[{'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Escudier', 'Affiliation': 'Department of Oncology Medicine, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Department of Medical Oncology, Georgetown Lombardi University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Urologic Oncology, Baylor Sammons Cancer Center-Texas Oncology, Dallas, TX, USA.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Internal Medicine, University of Pavia Chief, Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Verzoni', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Needle', 'Affiliation': 'AVEO Oncology, Boston, MA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Powers', 'Affiliation': 'AVEO Oncology, Boston, MA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Department of Hematology/Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN, USA. Electronic address: brian.rini@vumc.org.'}]",European urology,['10.1016/j.eururo.2020.08.007']
1956,32883279,Cost-effectiveness of a lifestyle intervention in high-risk individuals for diabetes in a low- and middle-income setting: Trial-based analysis of the Kerala Diabetes Prevention Program.,"BACKGROUND
Data on the cost-effectiveness of lifestyle-based diabetes prevention programs are mostly from high-income countries, which cannot be extrapolated to low- and middle-income countries. We performed a trial-based cost-effectiveness analysis of a lifestyle intervention targeted at preventing diabetes in India.
METHODS
The Kerala Diabetes Prevention Program was a cluster-randomized controlled trial of 1007 individuals conducted in 60 polling areas (electoral divisions) in Kerala state. Participants (30-60 years) were those with a high diabetes risk score and without diabetes on an oral glucose tolerance test. The intervention group received a 12-month peer-support lifestyle intervention involving 15 group sessions delivered in community settings by trained lay peer leaders. There were also linked community activities to sustain behavior change. The control group received a booklet on lifestyle change. Costs were estimated from the health system and societal perspectives, with 2018 as the reference year. Effectiveness was measured in terms of the number of diabetes cases prevented and quality-adjusted life years (QALYs). Three times India's gross domestic product per capita (US$6108) was used as the cost-effectiveness threshold. The analyses were conducted with a 2-year time horizon. Costs and effects were discounted at 3% per annum. One-way and multi-way sensitivity analyses were performed.
RESULTS
Baseline characteristics were similar in the two study groups. Over 2 years, the intervention resulted in an incremental health system cost of US$2.0 (intervention group: US$303.6; control group: US$301.6), incremental societal cost of US$6.2 (intervention group: US$367.8; control group: US$361.5), absolute risk reduction of 2.1%, and incremental QALYs of 0.04 per person. From a health system perspective, the cost per diabetes case prevented was US$95.2, and the cost per QALY gained was US$50.0. From a societal perspective, the corresponding figures were US$295.1 and US$155.0. For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively. The corresponding figures for QALY gained were 99.1% and 97.8%. The results were robust to discounting and sensitivity analyses.
CONCLUSIONS
A community-based peer-support lifestyle intervention was cost-effective in individuals at high risk of developing diabetes in India over 2 years.
TRIAL REGISTRATION
The trial was registered with Australia and New Zealand Clinical Trials Registry ( ACTRN12611000262909 ). Registered 10 March 2011.",2020,"For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively.","['1007 individuals conducted in 60 polling areas (electoral divisions) in Kerala state', 'Participants (30-60\u2009years) were those with a high diabetes risk score and without diabetes on an oral glucose tolerance test', 'high-risk individuals for diabetes in a low- and middle-income setting']","['community-based peer-support lifestyle intervention', '12-month peer-support lifestyle intervention involving 15 group sessions delivered in community settings by trained lay peer leaders', 'lifestyle intervention', 'booklet on lifestyle change']","['Effectiveness', 'Costs and effects', 'Cost-effectiveness', 'incremental health system cost']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",1007.0,0.029418,"For the number of diabetes cases prevented, the probability for the intervention to be cost-effective was 84.0% and 83.1% from the health system and societal perspectives, respectively.","[{'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Sathish', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. speaktosat@gmail.com.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kavumpurathu R', 'Initials': 'KR', 'LastName': 'Thankappan', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Pilvikki', 'Initials': 'P', 'LastName': 'Absetz', 'Affiliation': 'Department of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Robyn J', 'Initials': 'RJ', 'LastName': 'Tapp', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Paul Z', 'Initials': 'PZ', 'LastName': 'Zimmet', 'Affiliation': 'Central Clinical School, Monash University, Melbourne, UK.'}, {'ForeName': 'Sajitha', 'Initials': 'S', 'LastName': 'Balachandran', 'Affiliation': 'Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India.'}, {'ForeName': 'Suman S', 'Initials': 'SS', 'LastName': 'Shetty', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Aziz', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Mahal', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia.'}]",BMC medicine,['10.1186/s12916-020-01704-9']
1957,32893063,"Corrigendum re ""Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer-Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial"" [Eur Urol 2019;76:823-30].",,2020,,[],"['Corrigendum re ""Docetaxel Versus Surveillance', 'Radical Radiotherapy']",[],[],"[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0129467,,"[{'ForeName': 'Pirkko-Liisa', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Tampere University Hospital, Tampere, Finland. Electronic address: pirkko-liisa.kellokumpu-lehtinen@tuni.fi.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hjälm-Eriksson', 'Affiliation': 'Department of Surgery, Capio S.T. Görans Hospital, Stockholm, Sweden; Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Thellenberg-Karlsson', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Lennat', 'Initials': 'L', 'LastName': 'Åström', 'Affiliation': 'Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Franzen', 'Affiliation': 'Sundsvall University Hospital, Sundsvall, Sweden.'}, {'ForeName': 'Ann-Fofie', 'Initials': 'AF', 'LastName': 'Fransson', 'Affiliation': 'Gävle Central Hospital, Gävle, Sweden.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Leskinen', 'Affiliation': 'Seinäjoki Central Hospital, Seinäjoki, Finland.'}, {'ForeName': 'Mihalj', 'Initials': 'M', 'LastName': 'Zeke', 'Affiliation': 'Växjö Central Hospital, Växjö, Sweden.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Huttunen', 'Affiliation': '4Pharma, Turku, Finland.'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Ginman', 'Affiliation': 'Karlstad Central Hospital, Karlstad, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.08.035']
1958,32896089,Effect of behavioral intervention on medication adherence among elderly with select non-communicable diseases (ENDORSE): Pilot randomized controlled trial.,"AIM
Adherence to medication is important in older patients with non-communicable diseases, and there is a need to investigate various interventions to enhance adherence in our Indian setting. This pilot randomized controlled trial aimed at testing the effectiveness of systematic education and behavioral intervention in enhancing medication adherence among older adults.
METHODS
It was a single center, open label, parallel arm, randomized controlled trial carried out among older (age >60 years) inpatients of general medicine wards diagnosed with select non-communicable diseases, such as diabetes, hypertension, dyslipidemia and coronary artery disease. Participants were randomized either to receive the usual standard of care or the intervention that comprises of systematic education, patient diary to mark daily medicine intake and periodic telephone reminders. Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period. The primary end-points were change in the reported pill count (RPC) within groups and between groups at the third and sixth month.
RESULTS
The RPC in control and intervention arms at the thrid month were 78.20% and 91.88% (P = 0.007), whereas at 6 months they were 68.64% and 83.08% (P = 0.003), respectively. Similarly, change in RPC in intervention arm between baseline and the third month (mean difference 24.08%, P = 0.001), and between baseline and the sixth month (mean difference 15.280%, P = 0.006) were statistically significant. However, the RPC between the third and sixth month showed a significant decline (mean difference 8.8%, P = 0.016).
CONCLUSION
In this pilot study, we prove that behavioral interventions have improved medication adherence among older adults, and it is feasible to carry out such studies among older adults in India. Geriatr Gerontol Int 2020; 20: 1079-1084.",2020,Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period.,"['older adults', 'elderly with select non-communicable diseases (ENDORSE', 'older patients with non-communicable diseases', 'older adults in India', 'older (age >60\u2009years) inpatients of general medicine wards diagnosed with select non-communicable diseases, such as diabetes, hypertension, dyslipidemia and coronary artery disease']","['behavioral interventions', 'usual standard of care or the intervention that comprises of systematic education, patient diary to mark daily medicine intake and periodic telephone reminders', 'systematic education and behavioral intervention', 'behavioral intervention']","['change in RPC', 'pill count (RPC', 'medication adherence']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",,0.0561124,Barriers to medication adherence were identified and interventions were tailored according to the identified barriers over a 6-month follow-up period.,"[{'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Raj', 'Affiliation': ""Department of Pharmacology, St. John's Medical College, Bengaluru, India.""}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Mathews', 'Affiliation': ""Division of Geriatrics, Department of Medicine, St. John's Medical College, Bengaluru, India.""}]",Geriatrics & gerontology international,['10.1111/ggi.14032']
1959,32898787,"Calorie restriction and synbiotics effect on quality of life and edema reduction in breast cancer-related lymphedema, a clinical trial.","BACKGROUND
Little evidence exists regarding the clinical value of synbiotics in the management of post-treatment complications of breast cancer especially breast cancer-related lymphedema (BCRL). This study aimed to investigate the effects of synbiotic supplementation along with calorie restriction on quality of life and edema volume in patients with BCRL.
METHODS
This randomized, placebo-controlled, clinical trial was conducted on 135 overweight and obese women with BCRL aged 18-65 years old. Participants were randomly allocated to receive a calorie-restricted diet plus 10 9 CFU synbiotic supplement (CRS group; n = 45) or placebo (CRP group; n = 45), daily for 10 weeks. Also, a control group (n = 45) with no intervention was included in the trial. All of the participants received Complete Decongestive Therapy for lymphedema treatment. The quality of life score, edema volume and body mass index (BMI) were measured at baseline and end of the trial.
RESULTS
A total of 121 subjects completed the trial. CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control. However, there were no significant differences in changes in trial outcomes between the CRS and CRP groups.
CONCLUSION
Synbiotic supplementation along with a low-calorie diet was effective in quality of life, edema volume, and BMI improvement; mostly due to low-calorie diet. It seems that adding a dietitian consultation on the lymphedema management strategy may provide a better result in lymphedema control.",2020,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","['patients with BCRL', 'breast cancer-related lymphedema', '135 overweight and obese women with BCRL aged 18-65 years old', 'breast cancer especially breast cancer-related lymphedema (BCRL', '121 subjects completed the trial']","['synbiotic supplementation', 'CRS', 'Synbiotic supplementation', 'placebo', 'calorie-restricted diet plus 10 9 \xa0CFU synbiotic supplement (CRS group; n\xa0=\xa045) or placebo (CRP', 'calorie restriction', 'Complete Decongestive Therapy']","['BMI', 'quality of life, edema volume, and BMI improvement', 'quality of life and edema volume', 'edema volume', 'quality of life score, edema volume and body mass index (BMI', 'total quality of life score', 'quality of life and edema reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0474212', 'cui_str': 'Reduction of edema'}]",135.0,0.165473,"CRS group showed a significant decrease in the total quality of life score (P = 0.004), and it's psychosocial (P = 0.022) and functional (P = 0.002) domain scores, as well as edema volume (P = 0.002) and BMI (P < 0.001) in comparison to the control.","[{'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. Electronic address: zarrati_ms@yahoo.com.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Malakootinejad', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali Saneei', 'Initials': 'AS', 'LastName': 'Totmaj', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Zayeri', 'Affiliation': 'Proteomics Research Center and Department of Biostatistics, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Sanati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahpar', 'Initials': 'S', 'LastName': 'Haghighat', 'Affiliation': 'Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran. Electronic address: sha_haghighat@yahoo.com.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.08.008']
1960,32899902,Effect of Passive Stretching of Respiratory Muscles on Chest Expansion and 6-Minute Walk Distance in COPD Patients.,"BACKGROUND
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Hyperinflation of the lungs leads to a remodeling of the inspiratory muscles that causes postural deformities and more labored breathing. Postural changes include elevated, protracted, or abducted scapulae with medially rotated humerus, and kyphosis that leads to further tightening of respiratory muscles. As the severity of the disease progresses, use of the upper limbs for functional tasks becomes difficult due to muscle stiffness. There are various studies that suggest different rehabilitation programs for COPD patients; however, to the best of our knowledge none recommends passive stretching techniques. The aim of this study was to assess the effect of respiratory muscle passive stretching on chest expansion and 6-min walk distance (6MWD) in patients with moderate to severe COPD.
METHODS
Thirty patients were divided into two groups, experimental ( n = 15) and control ( n = 15). The experimental group received a hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints. The control group received a hot pack followed by relaxed passive movements of the shoulder joints.
RESULTS
In the control group, there was no difference in chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD between baseline and post treatment ( p > 0.05). In the experimental group, chest expansion at the level of the axilla ( p < 0.05) and 6MWD ( p < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p > 0.05). A comparison between control and experimental groups showed that chest expansion at the level of the axilla ( p < 0.05) and 6MWD ( p < 0.01) were significantly higher in the experimental group, while there was no difference in chest expansion at the level of the xiphisternum ( p > 0.05).
CONCLUSIONS
Although COPD is an irreversible disease, results of this study indicate that passive stretching of respiratory muscles can clinically improve the condition of such patients, especially in terms of chest expansion and 6MWD. Given the good effects of muscle stretching and the fact that such an exercise is harmless, clinicians and physiotherapists should consider including passive stretching of respiratory muscles in the rehabilitation plan of COPD patients.",2020,"In the experimental group, chest expansion at the level of the axilla ( p < 0.05) and 6MWD ( p < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p > 0.05).","['COPD patients', 'Chronic obstructive pulmonary disease (COPD', 'patients with moderate to severe COPD', 'COPD Patients', 'Thirty patients']","['Passive Stretching of Respiratory Muscles', 'hot pack followed by stretching of the respiratory muscles and relaxed passive movements of the shoulder joints', 'respiratory muscle passive stretching', 'hot pack followed by relaxed passive movements of the shoulder joints']","['chest expansion', 'chest expansion at the levels of both the axilla and the xiphisternum or in 6MWD', 'chest expansion and 6-min walk distance (6MWD', 'Chest Expansion and 6-Minute Walk Distance', '6MWD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}]","[{'cui': 'C0231902', 'cui_str': 'Chest expansion'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004454', 'cui_str': 'Axillary'}, {'cui': 'C0043356', 'cui_str': 'Structure of xiphoid process of sternum'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",30.0,0.0204537,"In the experimental group, chest expansion at the level of the axilla ( p < 0.05) and 6MWD ( p < 0.001) were significantly higher post treatment, while there was no difference in chest expansion at the level of the xiphisternum ( p > 0.05).","[{'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Rehman', 'Affiliation': 'Al Hosn One Day Surgery Center LLC, Al Sahel Tower Building, Post Box 37384, Abu Dhabi, UAE.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Ganai', 'Affiliation': 'Department of Rehabilitation Sciences, Jamia Hamdard, New Delhi 110062, India.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Aggarwal', 'Affiliation': 'Neuro-Physiotherapy Unit, NSC, All India Institute of Medical Sciences, New Delhi 110029, India.'}, {'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}, {'ForeName': 'Zaheen A', 'Initials': 'ZA', 'LastName': 'Iqbal', 'Affiliation': 'Rehabilitation Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh 11433, Saudi Arabia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186480']
1961,32902561,"Perioperative Open-lung Approach, Regional Ventilation, and Lung Injury in Cardiac Surgery.","BACKGROUND
In the Protective Ventilation in Cardiac Surgery (PROVECS) randomized, controlled trial, an open-lung ventilation strategy did not improve postoperative respiratory outcomes after on-pump cardiac surgery. In this prespecified subanalysis, the authors aimed to assess the regional distribution of ventilation and plasma biomarkers of lung epithelial and endothelial injury produced by that strategy.
METHODS
Perioperative open-lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass. Control ventilation strategy was a low-PEEP (2 cm H2O) low-tidal volume approach. Electrical impedance tomography was used serially throughout the perioperative period (n = 56) to compute the dorsal fraction of ventilation (defined as the ratio of dorsal tidal impedance variation to global tidal impedance variation). Lung injury was assessed serially using biomarkers of epithelial (soluble form of the receptor for advanced glycation end-products, sRAGE) and endothelial (angiopoietin-2) lung injury (n = 30).
RESULTS
Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery were studied. Induction of general anesthesia was associated with ventral redistribution of tidal volumes and higher dorsal fraction of ventilation in the open-lung than the control strategy (0.38 ± 0.07 vs. 0.30 ± 0.10; P = 0.004). No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999). Open-lung ventilation was associated with increased intraoperative plasma sRAGE (7,677 ± 3,097 pg/ml vs. 6,125 ± 1,400 pg/ml; P = 0.037) and had no effect on angiopoietin-2 (P > 0.999).
CONCLUSIONS
In cardiac surgery patients, open-lung ventilation provided larger dorsal lung ventilation early during surgery without a maintained benefit as compared with controls at the end of surgery and postoperative day 2 and was associated with higher intraoperative plasma concentration of sRAGE suggesting lung overdistension.
EDITOR’S PERSPECTIVE
",2020,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"['cardiac surgery patients', 'Eighty-six patients (age = 64 ± 12 yr; EuroSCORE II = 1.65 ± 1.57%) undergoing elective on-pump cardiac surgery']","['open-lung ventilation', 'lung ventilation consisted of recruitment maneuvers, positive end-expiratory pressure (PEEP) = 8 cm H2O, and low-tidal volume ventilation including during cardiopulmonary bypass']","['postoperative respiratory outcomes', 'dorsal lung ventilation', 'dorsal fraction of ventilation', 'intraoperative plasma sRAGE', 'ventral redistribution of tidal volumes and higher dorsal fraction of ventilation']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0182537', 'cui_str': 'Pump'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0332620', 'cui_str': 'Redistribution'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0821825,No effect of the open-lung strategy on the dorsal fraction of ventilation was noted at the end of surgery after median sternotomy closure (open-lung = 0.37 ± 0.09 vs. control = 0.34 ± 0.11; P = 0.743) or in extubated patients at postoperative day 2 (open-lung = 0.63 ± 0.18 vs. control = 0.59 ± 0.11; P > 0.999).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lagier', 'Affiliation': ''}, {'ForeName': 'Lionel J', 'Initials': 'LJ', 'LastName': 'Velly', 'Affiliation': ''}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Guinard', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': ''}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Guidon', 'Affiliation': ''}, {'ForeName': 'Marcos F', 'Initials': 'MF', 'LastName': 'Vidal Melo', 'Affiliation': ''}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Alessi', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000003539']
1962,32910735,Validation of a Novel Wearable Electromyography Patch for Monitoring Submental Muscle Activity During Swallowing: A Randomized Crossover Trial.,"Purpose Surface electromyography (sEMG) is often used for biofeedback during swallowing rehabilitation. However, commercially available sEMG electrodes are not optimized for the head and neck area, have rigid form, and are mostly available in large medical centers. We developed an ultrathin, soft, and flexible sEMG patch, specifically designed to conform to the submental anatomy and which will be ultimately incorporated into a telehealth system. To validate this first-generation sEMG patch, we compared its safety, efficiency, and signal quality in monitoring submental muscle activity with that of widely used conventional sEMG electrodes. Method A randomized crossover design was used to compare the experimental sEMG patch with conventional (snap-on) sEMG electrodes. Participants completed the same experimental protocol with both electrodes in counterbalanced order. Swallow trials included five trials of 5- and 10-ml water. Comparisons were made on (a) signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort. Noninferiority and equivalence tests were used to examine signal-related factors. Paired t tests and descriptive statistics were used to examine safety/preclinical factors. Results Forty healthy adults participated (24 women, M age = 67.5 years). Signal-related factors: SNR of the experimental patch was not inferior to the SNR of the conventional electrodes ( p < .0056). Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p < .0001). Finally, normalized amplitude values were equivalent across swallows (5 ml: p < .025; 10 ml: p < .0012), and sEMG burst duration was also equivalent (5 ml: p < .0001; 10 ml: p < .0001). Safety/preclinical factors: The experimental patch resulted in fewer mild adverse effects. Participant satisfaction was higher with the experimental patch ( p = .0476, d = 0.226). Conclusions Our new wearable sEMG patch is equivalent with widely used conventional sEMG electrodes in terms of technical performance. In addition, our patch is safe, and healthy older adults are satisfied with it. With lessons learned from the current COVID-19 pandemic, efforts to develop optimal swallowing telerehabilitation devices are more urgent than ever. Upon further validation, this new technology has the potential to improve rehabilitation and telerehabilitation efforts for patients with dysphagia. Supplemental Material https://doi.org/10.23641/asha.12915509.",2020,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p < .0001).","['During Swallowing', 'Forty healthy adults participated (24 women, M age = 67.5 years', 'patients with dysphagia', 'healthy older adults']","['Surface electromyography (sEMG', 'sEMG patch with conventional (snap-on) sEMG electrodes', 'Novel Wearable Electromyography Patch']","['sEMG burst duration', 'normalized amplitude values', 'Safety/preclinical factors', 'mild adverse effects', 'signal-related factors: signal-to-noise ratio (SNR), baseline amplitude, normalized mean amplitude, and sEMG burst duration and (b) safety/preclinical factors: safety/adverse effects, efficiency of electrode placement, and satisfaction/comfort', 'Participant satisfaction', 'Monitoring Submental Muscle Activity', 'safety, efficiency, and signal quality']","[{'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1177045', 'cui_str': 'Snap'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]","[{'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",40.0,0.0897228,"Similarly, baseline amplitude obtained with the experimental patch was not inferior to that obtained with conventional electrodes ( p < .0001).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Kantarcigil', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Min Ku', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Taehoo', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'School of Materials Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Craig', 'Affiliation': 'Department of Statistics, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Chi Hwan', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'School of Biomedical Engineering, Purdue University, West Lafayette, IN.'}, {'ForeName': 'Georgia A', 'Initials': 'GA', 'LastName': 'Malandraki', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, Purdue University, West Lafayette, IN.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00171']
1963,32905889,Role of inhaled corticosteroids in reducing exacerbations in bronchiectasis patients with blood eosinophilia pooled post-hoc analysis of 2 randomized clinical trials.,,2020,,['bronchiectasis patients with blood eosinophilia'],['inhaled corticosteroids'],[],"[{'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0014457', 'cui_str': 'Eosinophilia'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.174446,,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Martinez-Garcia', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain. Electronic address: mianmartinezgarcia@gmail.com.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Posadas', 'Affiliation': 'Pneumology Department, Hospital Universitario i Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sotgiu', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Blasi', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Saderi', 'Affiliation': 'Clinical Epidemiology and Medical Statistics Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy. Electronic address: lsaderi@uniss.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': ""University of Milan, Department of Pathophysiology and Transplantation, Milan, Italy; Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Respiratory Unit and Cystic Fibrosis Adult Center, Milan, Italy.""}]",Respiratory medicine,['10.1016/j.rmed.2020.106127']
1964,32905893,12-months follow-up of pulmonary tele-rehabilitation versus standard pulmonary rehabilitation: A multicentre randomised clinical trial in patients with severe COPD.,"Between March 2016 and October 2017, we randomised 134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group). We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme. The current study presents results from the 12-month follow-up with assessment of the 6MWD and analyses of hospitalisation and mortality. There were no significant differences between or within the groups in the 6MWD one year after completion of the programme.",2020,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"['134 patients with severe COPD from 8 hospitals in the Capital Region of Denmark to participate in either standardised, outpatient', 'patients with severe COPD']","['pulmonary rehabilitation (control group) or on-line, supervised and home-based tele-rehabilitation (intervention group', 'pulmonary tele-rehabilitation versus standard pulmonary rehabilitation']",['minutes walking distance (6MWD'],"[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}]",134.0,0.0811644,We found no difference between the groups in the primary outcome: six minutes walking distance (6MWD) after completion of the programme.,"[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark; Institute for Clinical Medicine, University of Copenhagen, Denmark. Electronic address: Nina.Skavlan.Godtfredsen@regionh.dk.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'The Research Unit for General Practice, Department of Public Health, University of Copenhagen, And Innovation and Research Centre for Multimorbidity and Chronic Conditions, Region Zealand, Denmark.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical & Occupational Therapy, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Department of Respiratory Medicine, Gentofte and Herlev University Hospital, Gentofte, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle Frost', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød University Hospital, Hillerød, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106129']
1965,32912192,Antibiotic prescribing and non-prescribing in nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA): study protocol for a cluster randomized controlled trial.,"BACKGROUND
Antibiotic overprescribing for suspected urinary tract infection (UTI) in nursing homes (NHs) is common. Typical clinical scenarios in which antibiotics are inappropriately prescribed include response to nonspecific signs and symptoms and/or a positive urine test in the absence of symptoms referable to the urinary tract. These and other scenarios for inappropriate antibiotic prescribing were addressed in a recent international Delphi study which resulted in the development of a decision tool for the empiric treatment of UTI in frail older adults. The aim of the current study is to implement this decision tool, by integrating it into the electronic health record (EHR) and providing education on its content and use, and to evaluate its effect on appropriate antibiotic prescribing. An additional aim is to evaluate the quality of the intervention and the implementation process.
METHODS
A cluster Randomized Controlled Trial (cRCT) is conducted in sixteen NHs and aims to include 897 residents diagnosed with suspected UTI. NHs in the intervention group use the EHR-integrated decision tool, and receive education for physicians and nursing staff; in the control group care as usual is provided. Data is collected through case report forms within the EHR at the day of diagnosis and at 3, 7, and 21 days thereafter. The primary outcome is appropriate antibiotic prescribing for suspected UTI at the day of diagnosis. Secondary outcomes include the course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality. Data on total antibiotic prescribing are additionally collected in the participating NHs 12 months before and during the study. Finally, the process evaluation combines cRCT data with questionnaires and qualitative interviews with NH professionals.
DISCUSSION
This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents. Study findings will elucidate the effect of the intervention on appropriate antibiotic prescribing for suspected UTI, and provide insight into the applicability of the decision tool in NHs in general and in specific subgroups of NH residents. With this study we aim to contribute to antibiotic stewardship efforts in long-term care.
TRIAL REGISTRATION
The ANNA study was registered at the Netherlands Trial Register on 26 February 2019, with identification number NTR NL7555 .",2020,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","['897 residents diagnosed with suspected UTI', '26 February 2019, with identification number NTR NL7555 ', 'frail older adults', 'nursing home residents with signs and symptoms ascribed to urinary tract infection (ANNA']",['Antibiotic prescribing and non-prescribing'],"['total antibiotic prescribing', 'appropriate antibiotic prescribing for suspected UTI at the day of diagnosis', 'course of symptoms, alternative diagnoses, treatment changes, complications, hospitalization, and mortality']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1277624', 'cui_str': 'Suspected UTI (urinary tract infection)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2919691', 'cui_str': 'Treatment changed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0993058,"This is the first cRCT to evaluate the recently developed, international decision tool for empiric treatment of suspected UTI in NH residents.","[{'ForeName': 'Jeanine J S', 'Initials': 'JJS', 'LastName': 'Rutten', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Laura W', 'Initials': 'LW', 'LastName': 'van Buul', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands. L.vanbuul@amsterdamumc.nl.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Smalbrugge', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases division, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Debby L', 'Initials': 'DL', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Primary and Community care, Radboud Institute for Health Sciences, Radboudumc Alzheimer Center, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Natsch', 'Affiliation': 'Department of Pharmacy, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'Department of Family Medicine, School of Medicine, and the Cecil G. Sheps Center for Health Services Research, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Veenhuizen', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}, {'ForeName': 'Cees M P M', 'Initials': 'CMPM', 'LastName': 'Hertogh', 'Affiliation': 'Department of Medicine for Older People, Amsterdam University Medical Center, Vrije Universiteit, Van der Boechorststraat 7, 1081, BT, Amsterdam, the Netherlands.'}]",BMC geriatrics,['10.1186/s12877-020-01662-0']
1966,32913021,Effect of escitalopram dose and treatment duration on CSF Aβ levels in healthy older adults: A controlled clinical trial.,"OBJECTIVE
To determine whether treatment with escitalopram compared with placebo would lower CSF β-amyloid 42 (Aβ 42 ) levels.
RATIONALE
Serotonin signaling suppresses Aβ 42 in animal models of Alzheimer disease (AD) and young healthy humans. In a prospective study in older adults, we examined dose and treatment duration effects of escitalopram.
METHODS
Using lumbar punctures to sample CSF levels before and after a course of escitalopram treatment, cognitively normal older adults (n = 114) were assigned to placebo, 20 mg escitalopram × 2 weeks, 20 mg escitalopram × 8 weeks, or 30 mg escitalopram × 8 weeks; CSF sampled pretreatment and posttreatment and within-subject percent change in Aβ 42 was used as the primary outcome in subsequent analyses.
RESULTS
An overall 9.4% greater reduction in CSF Aβ 42 was found in escitalopram-treated compared with placebo-treated groups ( p < 0.001, 95% confidence interval [CI] 4.9%-14.2%, d = 0.81). Positive baseline Aβ status (CSF Aβ 42 levels <250 pg/mL) was associated with smaller Aβ 42 reduction ( p = 0.006, 95% CI -16.7% to 0.5%, d = -0.52) compared with negative baseline amyloid status (CSF Aβ 42 levels >250 pg/mL).
CONCLUSIONS
Short-term longitudinal doses of escitalopram decreased CSF Aβ 42 in cognitively normal older adults, the target group for AD prevention.
CLINICALTRIALSGOV IDENTIFIER
NCT02161458.
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence that for cognitively normal older adults, escitalopram decreases CSF Aβ 42 .",2020,An overall 9.4% percentage point greater reduction in CSF Aβ 42 was found in ESC treated compared with placebo treated groups ( p < 0.001; 95% CI [4.9%-14.2%]; d = 0.81).,"['older adults', 'healthy older adults', 'cognitively normal older adults (n = 114', ""42 in animal models of Alzheimer's disease (AD) and young healthy humans"", 'cognitively normal older adults, ESC decreases CSF Aβ 42 ', 'cognitively normal older adults']","['ESC treatment', 'ESC', 'placebo, treatment with escitalopram (ESC', 'placebo; 20 mg ESC', 'escitalopram', 'placebo']","['Positive baseline amyloid-beta status ', 'CSF (CSF) amyloid beta 42 (Aβ 42 ) levels', 'CSF Aβ levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0012644', 'cui_str': 'Animal Disease Models'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",114.0,0.0976057,An overall 9.4% percentage point greater reduction in CSF Aβ 42 was found in ESC treated compared with placebo treated groups ( p < 0.001; 95% CI [4.9%-14.2%]; d = 0.81).,"[{'ForeName': 'Yvette I', 'Initials': 'YI', 'LastName': 'Sheline', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York. sheline@pennmedicine.upenn.edu.'}, {'ForeName': 'B Joy', 'Initials': 'BJ', 'LastName': 'Snider', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Joanne C', 'Initials': 'JC', 'LastName': 'Beer', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Darsol', 'Initials': 'D', 'LastName': 'Seok', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fagan', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Suckow', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Jin-Moo', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Waligorska', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Korecka', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Irem', 'Initials': 'I', 'LastName': 'Aselcioglu', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Morris', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Shaw', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Cirrito', 'Affiliation': 'From the Center for Neuromodulation in Depression and Stress, Department of Psychiatry (Y.I.S., D.S., I.A.), and Departments of Radiology (Y.I.S.), Neurology (Y.I.S.), Biostatistics, Epidemiology and Bioinformatics (J.C.B.), and Pathology (T.W., M.K., L.M.S.), University of Pennsylvania, Philadelphia; Department of Neurology, The Knight Alzheimer Disease Research Center, Hope Center for Neurological Disorders (B.J.S., A.M.F., J.-M.L., J.C.M., J.R.C.), Washington University School of Medicine, St Louis MO; and New York State Psychiatric Institute and Department of Psychiatry (R.F.S.), Columbia University, New York.'}]",Neurology,['10.1212/WNL.0000000000010725']
1967,32916181,The effects of an exercise training on steroid hormones in preadolescent children - a moderator for enhanced cognition?,"OBJECTIVE
Research demonstrates a variety of cognitive benefits induced by different chronic physiological stressors (e.g. motor vs. cardiovascular exercise training) and acute exercise to affect steroid hormone secretion, the present study aims to investigate 1.) motor vs. cardiovascular exercise training and their impact on salivary Testosterone, Estradiol and Progesterone and 2.) whether alterations in steroid hormones might moderate exercise-induced cognitive benefits.
METHODS
In a randomized control trial, 71 preadolescent children (39 girls) at the age of 9-10 years were randomly assigned to a cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON) in which students were attending assisted homework. The participants attended their program three times per week, for a total of 10 weeks. Steroid hormones in the saliva, working memory performance and state-trait anxiety levels were determined before and after the intervention.
RESULTS
Statistical analysis showed no chronic changes in hormones through the interventions. Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014). Within the ME, increases of Testosterone from t 1 to t 2 were predicting higher working memory performance post-intervention (β = 0.45, R 2 = 0.16, p = 0.038).
CONCLUSION
Our findings suggest 1.) that motor-exercise-induced cognitive benefits are moderated by changes in Testosterone and 2.) that a 10-week exercise training of moderate intensity and with a motor demanding vs a cardiovascular character does not affect the chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels in preadolescent children.",2020,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","['preadolescent children', '71 preadolescent children (39 girls) at the age of 9-10 years']","['cardiovascular exercise group (CE), a motor exercise group (ME) as well as a control group (CON', 'exercise training', 'motor vs. cardiovascular exercise training']","['salivary Testosterone, Estradiol and Progesterone and 2', 'saliva, working memory performance and state-trait anxiety levels', 'Testosterone', 'steroid hormones', 'chronic concentration of salivary Testosterone, Estradiol and Progesterone nor anxiety levels']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",71.0,0.0658097,"Stepwise hierarchical regression revealed the Testosterone*ME-interaction to be a significant moderator for working memory performance post-intervention (β = 0.48, p = 0.014).","[{'ForeName': 'Davin P', 'Initials': 'DP', 'LastName': 'Akko', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany; Faculty of Humanities and Social Sciences, University of Hagen, Hagen, Germany. Electronic address: davin-patrick.akko@fernuni-hagen.de.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Koutsandréou', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Murillo-Rodríguez', 'Affiliation': 'Escuela de Medicina, División Ciencias de la Salud, Universidad Anáhuac Mayab Mérida, Mérida, Yucatán, Mexico.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Wegner', 'Affiliation': 'Department of Sport Psychology, Institute of Sports Science, Humboldt University Berlin, Berlin, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Budde', 'Affiliation': 'Faculty of Human Sciences, Medical School Hamburg, Hamburg, Germany.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113168']
1968,32917359,"Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium) versus nebulized short-acting dual bronchodilator (salbutamol/ipratropium) in chronic obstructive pulmonary disease: A double-blind, randomized, placebo-controlled trial.","INTRODUCTION
Most guidelines recommend long-acting bronchodilators over short-acting bronchodilators for patients with chronic obstructive pulmonary disease (COPD). The available evidence for the guidelines was based on dry powder or pressurized metered dose inhalers, but not nebulizations. Nevertheless, there is considerable, poorly evidenced based, use of short acting nebulized bronchodilators.
METHODS
This was an investigator initiated, randomized, active controlled, cross-over, double-blind and double-dummy single centre study in patients with stable COPD. The active comparators were indacaterol/glycopyrronium 110/50 μg as Ultibro® via Breezhaler® (IND/GLY) and salbutamol/ipratropium 2,5/0,5 mg via air driven nebulization (SAL/IPR), both given as a single dose on separate days. The primary end point was the area under the FEV 1 curve from baseline till 6 h. Secondary end points included change in Borg dyspnoea score, adverse events and change in hyperinflation measured by the inspiratory capacity.
RESULTS
A total of 33 COPD patients completed the trial and were evaluable, most of them were ex-smokers. The difference between the tested regimens for the primary endpoint, FEV 1 AUC 0-6 h, 2965 ± 1544 mL (mean ± SD) for IND/GLY versus 3513 ± 1762 mL for SAL/IPR, was not significant (P = 0.08). The peak in FEV1 was higher and was reached faster with SAL/IPR compared to IND/GLY. No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
CONCLUSION
Among patients with stable COPD, dry powder long-acting single inhalation of a LABA and a LAMA (IND/GLY) was not superior compared to nebulized short-acting salbutamol plus ipratropium (SAL/IPR) in its bronchodilating effects over 6 h.The effects of the nebulization kicked in faster and peaked higher. The observed differences may be caused by the difference in dosing between the two regimens. The improvement in Borg dyspnoea score did not favour the nebulization. Long-term outcomes were not assessed in this study.",2020,"No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
","['chronic obstructive pulmonary disease', '33 COPD patients', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with stable COPD']","['IND', 'Long-acting dual bronchodilator therapy (indacaterol/glycopyrronium', 'salbutamol plus ipratropium (SAL/IPR', 'indacaterol/glycopyrronium 110/50\xa0μg as Ultibro® via Breezhaler® (IND/GLY) and salbutamol/ipratropium 2,5/0,5\xa0mg via air driven nebulization (SAL/IPR', 'placebo', 'nebulized short-acting dual bronchodilator (salbutamol/ipratropium']","['area under the FEV 1 curve', 'Borg score, or adverse events', 'peak in FEV1', 'Borg dyspnoea score', 'change in Borg dyspnoea score, adverse events and change in hyperinflation measured by the inspiratory capacity', 'FEV 1 AUC 0-6\xa0h, 2965\xa0±']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0578554', 'cui_str': 'Inhaled bronchodilator therapy'}, {'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C3814772', 'cui_str': 'glycopyrronium'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027235', 'cui_str': 'Ipratropium'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}]","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0020449', 'cui_str': 'Hyperdistention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",33.0,0.528759,"No other significant differences were detected for the secondary endpoints including the Borg score, or adverse events.
","[{'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Medical Centre Leeuwarden, Department of Respiratory Medicine, Leeuwarden, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands. Electronic address: wouter.van.geffen@znb.nl.'}, {'ForeName': 'Orestes A', 'Initials': 'OA', 'LastName': 'Carpaij', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Lotte F', 'Initials': 'LF', 'LastName': 'Westbroek', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Seigers', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Niemeijer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Vonk', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Department of Epidemiology, Groningen, the Netherlands.'}, {'ForeName': 'Huib A M', 'Initials': 'HAM', 'LastName': 'Kerstjens', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases, Groningen, the Netherlands; University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106064']
1969,32893313,Neurally adjusted ventilatory assist in acute respiratory failure: a randomized controlled trial.,"PURPOSE
We hypothesized that neurally adjusted ventilatory assist (NAVA) compared to conventional lung-protective mechanical ventilation (MV) decreases duration of MV and mortality in patients with acute respiratory failure (ARF).
METHODS
We carried out a multicenter, randomized, controlled trial in patients with ARF from several etiologies. Intubated patients ventilated for ≤ 5 days expected to require MV for ≥ 72 h and able to breathe spontaneously were eligible for enrollment. Eligible patients were randomly assigned based on balanced treatment assignments with a computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group). Allocation concealment was maintained at all sites during the trial. Primary outcome was the number of ventilator-free days (VFDs) at 28 days. Secondary outcome was all-cause hospital mortality. All analyses were done according to the intention-to-treat principle.
RESULTS
Between March 2014 and October 2019, we enrolled 306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group. Median VFDs were higher in the NAVA than in the control group (22 vs. 18 days; between-group difference 4 days; 95% confidence interval [CI] 0 to 8 days; p = 0.016). At hospital discharge, 39 (25.5%) patients in the NAVA group and 47 (30.7%) patients in the control group had died (between-group difference - 5.2%, 95% CI - 15.2 to 4.8, p = 0.31). Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
CONCLUSION
NAVA decreased duration of MV although it did not improve survival in ventilated patients with ARF.",2020,"Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
","['patients with ARF from several etiologies', 'Eligible patients', '306 patients and randomly assigned 153 patients to the NAVA group and 153 to the control group', 'acute respiratory failure', 'patients with acute respiratory failure (ARF', 'ventilated patients with ARF', 'Intubated patients ventilated for\u2009≤\u20095\xa0days expected to require MV for\u2009≥\u200972\xa0h and able to breathe spontaneously were eligible for enrollment', 'Between March 2014 and October 2019']","['conventional lung-protective mechanical ventilation (MV', 'neurally adjusted ventilatory assist (NAVA', 'NAVA', 'Neurally adjusted ventilatory assist', 'computerized randomization allocation sequence to two ventilatory strategies: (1) lung-protective MV (control group), and (2) lung-protective MV with NAVA (NAVA group']","['MV and mortality', 'number of ventilator-free days (VFDs', 'duration of MV', 'cause hospital mortality', 'died', 'Median VFDs', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0566270', 'cui_str': 'Able to breathe'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C3178854', 'cui_str': 'Neurally Adjusted Ventilatory Assist'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",306.0,0.274373,"Other clinical, physiological or safety outcomes did not differ significantly between the trial groups.
","[{'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Kacmarek', 'Affiliation': 'Department of Respiratory Care, Massachusetts General Hospital, 55 Fruit St, Warren 1225, Boston, MA, 01460, USA. rkacmarek@partners.org.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. jesus.villar54@gmail.com.'}, {'ForeName': 'Dácil', 'Initials': 'D', 'LastName': 'Parrilla', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alba', 'Affiliation': 'Intensive Care Unit, Hospital N.S. del Prado, Talavera de La Reina, Toledo, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Solano', 'Affiliation': 'Intensive Care Unit, Hospital Virgen de La Luz, Cuenca, Spain.'}, {'ForeName': 'Songqiao', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Intensive Care Unit, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Montiel', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rico-Feijoo', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Anxela', 'Initials': 'A', 'LastName': 'Vidal', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrando', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Murcia', 'Affiliation': 'Intensive Care Unit, Complejo Universitario de Albacete, Albacete, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Corpas', 'Affiliation': 'Intensive Care Unit, Hospital N.S. del Prado, Talavera de La Reina, Toledo, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'González-Higueras', 'Affiliation': 'Intensive Care Unit, Hospital Virgen de La Luz, Cuenca, Spain.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Intensive Care Unit, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'César E', 'Initials': 'CE', 'LastName': 'Pinedo', 'Affiliation': 'Intensive Care Unit, Hospital Universitario N.S. de Candelaria, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pestaña', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Ramón Y Cajal, IRYCIS, Madrid, Spain.'}, {'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Martínez', 'Affiliation': 'Intensive Care Unit, Hospital Universitario Virgen de Arrixaca, Murcia, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Aldecoa', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Añón', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Soro', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Jesús M', 'Initials': 'JM', 'LastName': 'González-Martín', 'Affiliation': 'Biostatistics Division, Research Unit, Universitario Dr. Negrín, Las Palmas, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fernández', 'Affiliation': 'Research Unit, Hospital Universitario Dr. Negrín, Barranco de la Ballena s/n, 4th Floor South Wing, 35019, Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Rosa L', 'Initials': 'RL', 'LastName': 'Fernández', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06181-5']
1970,32896498,Aqueous Cytokine Expression and Higher Order OCT Biomarkers: Assessment of the Anatomic-Biologic Bridge in the IMAGINE DME Study.,"PURPOSE
To identify biomarkers for predicting response to anti-vascular endothelial growth factor (VEGF) therapy in diabetic macular edema (DME) and evaluate any links between cytokine expression and optical coherence tomography (OCT) phenotype.
DESIGN
The IMAGINE is a post hoc image analysis and cytokine expression assessment of the Efficacy & Safety Trial of Intravitreal Injections Combined With PRP for CSME Secondary to Diabetes Mellitus (DAVE) randomized clinical trial.
METHODS
Subjects were categorized as anatomical responders or nonresponders, and within the responder group as rebounders and non-rebounders based on quantitative, longitudinal OCT criteria. Retinal layer and fluid features were extracted using an OCT machine-learning augmented segmentation platform. Responders were further sub-classified by rapidity of response. Aqueous concentrations of 54 cytokines were measured at multiple timepoints. Expression was compared between responder groups and correlated with OCT imaging biomarkers.
RESULTS
Of the 24 eyes studied, 79% were anatomical responders with 38% super responders, 17% early responders, and 25% slow responders. Twenty-one percent were nonresponders. Super responders had increased baseline vascular endothelial growth factor (VEGF) (880.0 pg/mL vs 245.4 pg/mL; P = .012) and decreased monocyte chemotactic protein-1 (MCP-1) (513.3 pg/mL vs 809.5 pg/mL; P = .0.042) concentrations compared with nonresponders. Interleukin-6 (-24.9 pg/mL vs 442.8 pg/mL; P = .032) concentrations increased among nonresponders during therapy. VEGF concentrations correlated with central subfield thickness (r = 0.49; P = .01). Panmacular retinal volume correlated with increased interleuckin-6 (r = 0.47; P = .02) and decreased MCP-1 (r = -0.45; P = .03). Matrix metallopeptidase-1 correlated with subretinal fluid volume (r = 0.50; P = .01).
CONCLUSIONS
OCT imaging biomarkers correlated with both intraocular cytokines and responsiveness to anti-VEGF therapy, which indicated a possible link to underlying pathways and their relevance to DME prognosis. Baseline concentrations of VEGF and MCP-1 are associated with anatomic response to anti-VEGF therapy.",2020,"Super Responders had increased baseline VEGF (880.0 vs 245.4 pg/mL, p=0.012) and decreased MCP-1 (513.3 vs 809.5 pg/mL, 0.042) concentrations compared to Nonresponders. IL-6","['24 eyes studied', 'Subjects were categorized as anatomical Responders or Nonresponders,and within the Responder group as Rebounders and Nonrebounders based on quantitative, longitudinal optical coherence tomography (OCT) criteria', 'diabetic macular edema (DME']","['IL-6', 'anti-VEGF therapy']","['MCP-1', 'baseline VEGF', 'SRF volume', 'Panmacular retinal volume correlated with increased IL-6', 'VEGF concentrations', 'Expression']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}]","[{'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",79.0,0.043668,"Super Responders had increased baseline VEGF (880.0 vs 245.4 pg/mL, p=0.012) and decreased MCP-1 (513.3 vs 809.5 pg/mL, 0.042) concentrations compared to Nonresponders. IL-6","[{'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Abraham', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Houston, Texas, USA; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas, USA.'}, {'ForeName': 'Sruthi', 'Initials': 'S', 'LastName': 'Arepalli', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Leina', 'Initials': 'L', 'LastName': 'Lunasco', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Yu', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Houston, Texas, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Reese', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Retina Consultants of America, Houston, Texas, USA; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas, USA.'}, {'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Vitreoretinal Service, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA. Electronic address: ehlersj@ccf.org.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.08.047']
1971,32897319,"Feasibility and Acceptability of an Abbreviated, Four-Week Mindfulness Program for Chronic Pain Management.","OBJECTIVE
The Mindfulness-Based Stress Reduction program is effective at improving chronic pain outcomes, but the time demand hinders participation. This preliminary study evaluated the feasibility, acceptability, and potential effects of providing an abbreviated mindfulness program for patients with chronic pain.
DESIGN
A single-arm, mixed-methods, pre-post intervention study.
SETTING
An outpatient rehabilitation clinic at an academic medical center.
SUBJECTS
Participants were N = 23 adults with chronic pain who were new to mindfulness practice.
METHODS
Mindfulness-based Stress Reduction was adapted to shorten the program to four weekly 90-minute sessions and to focus content on pain management. Three cohorts of six to nine participants completed baseline and post-treatment measures of 1) patient-reported outcomes, including pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences.
RESULTS
Acceptable rates of retention and attendance and high ratings of satisfaction indicated that the intervention was feasible and acceptable. In interviews, participants found the program acceptable and beneficial and provided suggestions to improve it. From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
CONCLUSIONS
In adults with chronic pain, a four-week mindfulness program is feasible and acceptable, addresses the barrier of a lengthy program, and may improve quality of life and psychological functioning. An appropriately powered randomized controlled trial with a comparison group is needed to assess the intervention's effectiveness.",2020,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","['Participants were N = 23 adults with chronic pain who were new to mindfulness practice', 'Chronic Pain Management', 'adults with chronic pain', 'An outpatient rehabilitation clinic at an academic medical center', 'patients with chronic pain']","['abbreviated mindfulness program', 'Abbreviated, Four-Week Mindfulness Program', 'Mindfulness-Based Stress Reduction program']","['Feasibility and Acceptability', 'physical functioning and anxiety', 'quality of life and psychological functioning', 'pain intensity, pain interference, physical functioning, depressive/anxiety symptoms, positive affect and well-being, and sleep disturbance; 2) pain medication dosages; 3) psychosocial variables including pain acceptance, pain catastrophizing, and perceived stress; 4) dispositional mindfulness, as well as postintervention structured interviews about their experiences', 'retention and attendance and high ratings of satisfaction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839785', 'cui_str': 'Rehabilitation clinic'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",23.0,0.0312875,"From pre- to post-treatment, significant improvements were reported in all measures except physical functioning and anxiety.
","[{'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'Brintz', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Roth', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Keturah', 'Initials': 'K', 'LastName': 'Faurot', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Gaylord', 'Affiliation': 'Program on Integrative Medicine, Department of Physical Medicine and Rehabilitation, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa208']
1972,32894857,Use of Azithromycin for the Prevention of Lung Injury in Mechanically Ventilated Preterm Neonates: A Randomized Controlled Trial.,"INTRODUCTION
Macrolides have anti-inflammatory and immunomodulatory properties that give this class of antibiotics a role that differs from its classical use as an antibiotic, which opens new therapeutic possibilities.
OBJECTIVE
The aim of this study was to evaluate the anti-inflammatory effect of azithromycin in preventing mechanical ventilation (MV)-induced lung injury in very-low-birth-weight preterm neonates.
METHODS
This is a randomized, double-blind, placebo-controlled trial of preterm neonates who received invasive MV within 72 h of birth. Patients were randomized to receive intravenous azithromycin (at a dose of 10/mg/kg/day for 5 days) or placebo (0.9% saline) within 12 h of the start of MV. Two blood samples were collected (before and after intervention) for measurement of interleukins (ILs) and PCR for Ureaplasma. Patients were followed up throughout the hospital stay for the outcomes of death and broncho-pulmonary dysplasia defined as need for oxygen for a period of ≥28 days of life (registered at ClinicalTrials.gov, No. NCT03485703).
RESULTS
Forty patients were analyzed in the azithromycin group and 40 in the placebo group. Five days after the last dose, serum IL-2 and IL-8 levels dropped significantly in the azithromycin group. There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood.
CONCLUSIONS
Azithromycin has anti-inflammatory effects, with a decrease in cytokines after 5 days of use and a reduction in death and O2 dependency at 28 days/death in mechanically ventilated preterm neonates.",2020,"There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood.
","['Mechanically Ventilated Preterm Neonates', 'mechanically ventilated preterm neonates', 'preterm neonates who received invasive MV within 72 h of birth', 'very-low-birth-weight preterm neonates']","['Azithromycin', 'placebo', 'intravenous azithromycin', 'azithromycin']","['incidence of death and O2 dependency', 'serum IL-2 and IL-8 levels', 'mechanical ventilation (MV)-induced lung injury', 'death and O2 dependency', 'death and broncho-pulmonary dysplasia defined as need for oxygen']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0345170', 'cui_str': 'Dysplasia of lung'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",40.0,0.683944,"There was a significant reduction in the incidence of death and O2 dependency at 28 days/death in azithromycin-treated patients regardless of the detection of Ureaplasma in blood.
","[{'ForeName': 'Cristiane R', 'Initials': 'CR', 'LastName': 'Nunes', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Renato S', 'Initials': 'RS', 'LastName': 'Procianoy', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Andréa L', 'Initials': 'AL', 'LastName': 'Corso', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Rita C', 'Initials': 'RC', 'LastName': 'Silveira', 'Affiliation': 'Graduate Program in Child and Adolescent Health, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil, drarita.c.s@gmail.com.'}]",Neonatology,['10.1159/000509462']
1973,32900671,"Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study.","BACKGROUND
Hypersexual disorder (HD) is a condition in which the individual experiences loss of control over engagement in sexual behaviors, leading to negative effects on various areas of life. Paraphilias often present concomitantly with HD, and although cognitive behavioral therapy (CBT) has been proven to reduce engagement in hypersexual behavior, no studies have investigated the effects of Internet-administered CBT (ICBT) on HD, with or without paraphilia(s) or paraphilic disorder(s).
AIM
To investigate the effects of Internet-administered CBT on HD, with or without paraphilia(s) or paraphilic disorder(s).
METHODS
Male participants (n = 36) evaluated positive according to the proposed diagnostic HD criteria, with or without paraphilia(s) or paraphilic disorder(s), received 12 weeks of ICBT. Measures were administered weekly over the treatment period, with an additional follow-up measurement 3 months after completion of treatment. An assessment interview was performed 2 weeks after treatment.
OUTCOMES
The primary outcome was the Hypersexual Behavior Inventory (HBI-19), and secondary outcomes were the Hypersexual Disorder: Current Assessment Scale (HD:CAS), the Sexual Compulsivity Scale (SCS), as well as a tentative composite of 6 Severity Self-rating Measures, for Paraphilic Disorders and depression (Montgomery-Åsberg Depression Rating Scale [MADRS-S]), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure [CORE-OM]), and treatment satisfaction (CSQ-8).
RESULTS
Large, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms. These effects remained stable 3 months after treatment.
CLINICAL IMPLICATIONS
ICBT can ameliorate HD symptoms, psychiatric distress, and paraphilic symptoms, which suggests that the ICBT for HD, with or without paraphilia(s) or paraphilic disorder(s), may constitute a valuable addition of treatment options in clinical settings.
STRENGTHS AND LIMITATIONS
This is the first study evaluating the efficacy of ICBT on a sample of men suffering from HD. In addition, a proportion of the sample reported concomitant paraphilic interests and disorders, thus mirroring an everyday clinical practice in the field of sexual medicine. No control group was assigned, and some of the outcome measures are still to be validated. The long-term effects of ICBT and its efficacy in hypersexual women are unknown.
CONCLUSIONS
This study gives support for ICBT as an effective treatment option for HD. Future evaluations of the treatment program should include women and larger samples in randomized controlled procedures and investigate the long-term effects. Hallberg J, Kaldo V, Arver S, et al. Internet-Administered Cognitive Behavioral Therapy for Hypersexual Disorder, With or Without Paraphilia(s) or Paraphilic Disorder(s) in Men: A Pilot Study. J Sex Med 2020;17:2039-2054.",2020,"Large, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms.","['men suffering from HD', 'hypersexual women', 'Men', 'Male participants (n\xa0=\xa036) evaluated positive according to the proposed diagnostic HD criteria, with or without paraphilia(s) or paraphilic disorder(s), received 12\xa0weeks of']","['cognitive behavioral therapy (CBT', 'Internet-administered CBT', 'Internet-Administered Cognitive Behavioral Therapy', 'ICBT', 'Paraphilic']","['HD symptoms, psychiatric distress, and paraphilic symptoms', 'Hypersexual Behavior Inventory (HBI-19), and secondary outcomes were the Hypersexual Disorder', 'Current Assessment Scale (HD:CAS), the Sexual Compulsivity Scale (SCS), as well as a tentative composite of 6 Severity Self-rating Measures, for Paraphilic Disorders and depression (Montgomery-Åsberg Depression Rating Scale [MADRS-S]), psychological distress (Clinical Outcomes in Routine Evaluation Outcome Measure [CORE-OM]), and treatment satisfaction (CSQ-8', 'HD symptoms and sexual compulsivity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030482', 'cui_str': 'Paraphilia'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030482', 'cui_str': 'Paraphilia'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0407582,"Large, significant decreases in HD symptoms and sexual compulsivity were found, as well as moderate improvements in psychiatric well-being and paraphilic symptoms.","[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hallberg', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm Sweden & Stockholm Healthcare Services, Stockholm County Council, Stockholm, Sweden; Department of Psychology, Faculty of Health and Life Sciences, Linnaeus University, Växjö, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Arver', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Dhejne', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Piwowar', 'Affiliation': 'Anova, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Jokinen', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm Sweden & Stockholm Healthcare Services, Stockholm County Council, Stockholm, Sweden; Department of Clinical Sciences/Psychiatry, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Katarina Görts', 'Initials': 'KG', 'LastName': 'Öberg', 'Affiliation': 'Department of Medicine, Karolinska Institutet, Stockholm, Sweden; Anova, Karolinska University Hospital, Stockholm, Sweden. Electronic address: katarina.gorts-oberg@sll.se.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.07.018']
1974,32909076,"A phase 2a randomised, double-blind, placebo-controlled, parallel-group, add-on clinical trial of ebselen (SPI-1005) as a novel treatment for mania or hypomania.","RATIONALE
Lithium is an effective prophylactic and anti-manic treatment in bipolar disorder; however, its use is declining through perceived poor tolerance and toxicity. Lithium inhibits inositol monophosphatase (IMPase), a probable key therapeutic mechanism. The anti-inflammatory drug, ebselen, also inhibits IMPase and appears well-tolerated and safe.
OBJECTIVES
To assess the efficacy of adjunctive ebselen in mania using the Young Mania Rating Scale (YMRS) (primary outcome) and the Altman Self-Rating Mania (ASRM) Scale and Clinical Global Impression-Severity Scale (CGI-S) among the secondary outcomes.
METHODS
Randomised, double-blind, placebo-controlled, parallel-group trial conducted between October 2017 and June 2019, at Oxford Health NHS Foundation Trust. Pharmacy-controlled randomisation was computer-generated, with full allocation concealment. In/outpatients (n = 68) aged 18-70, experiencing mania or hypomania, were assigned to 3 weeks ebselen (600 mg bd) (n = 33) or placebo (n = 35). Participants received usual clinical care and psychotropic medication.
RESULTS
Ebselen was numerically, but not statistically, superior to placebo in lowering scores on the YMRS (adjusted mean difference and 95% confidence interval, - 1.71 (- 5.34 to 1.91), p = 0.35) and ASRM (- 1.36 (- 3.75 to 1.17), p = 0.29). However, scores on the CGI-S were significantly lower at week 3 in ebselen-treated participants (adjusted mean difference, - 0.58 (- 1.14 to - 0.03), p = 0.04). A post hoc analysis excluding patients taking concomitant valproate treatment magnified the difference between ebselen and placebo on the YMRS. Adverse events were comparable between groups, and mild.
CONCLUSIONS
Ebselen merits further investigation where concomitant psychotropic medication is better controlled and participants taking valproate are excluded. If effective, ebselen's superior tolerance and safety could make it a useful alternative to lithium.
TRIAL REGISTRATION
Trial Registry: www.clinicaltrials.gov , Identifier: NCT03013400.",2020,"RESULTS
Ebselen was numerically, but not statistically, superior to placebo in lowering scores on the YMRS (adjusted mean difference and 95% confidence interval, - 1.71 (- 5.34 to 1.91), p = 0.35) and ASRM (- 1.36 (- 3.75 to 1.17), p = 0.29).","['October 2017 and June 2019, at Oxford Health NHS Foundation Trust', 'In/outpatients (n\u2009=\u200968) aged 18-70, experiencing mania or hypomania', 'bipolar disorder']","['Lithium inhibits inositol monophosphatase (IMPase', 'placebo', 'usual clinical care and psychotropic medication']","['YMRS', 'ASRM', 'Adverse events', 'Altman Self-Rating Mania (ASRM) Scale and Clinical Global Impression-Severity Scale (CGI-S', 'CGI-S', 'Young Mania Rating Scale (YMRS']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0241934', 'cui_str': 'Hypomania'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0163342', 'cui_str': '1L-myo-Inositol-1-phosphatase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.324514,"RESULTS
Ebselen was numerically, but not statistically, superior to placebo in lowering scores on the YMRS (adjusted mean difference and 95% confidence interval, - 1.71 (- 5.34 to 1.91), p = 0.35) and ASRM (- 1.36 (- 3.75 to 1.17), p = 0.29).","[{'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Sharpley', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Adele A', 'Initials': 'AA', 'LastName': 'Holder', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Beata R', 'Initials': 'BR', 'LastName': 'Godlewska', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK.'}, {'ForeName': 'Milensu', 'Initials': 'M', 'LastName': 'Shanyinde', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Orla', 'Initials': 'O', 'LastName': 'MacDonald', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Cowen', 'Affiliation': 'Neurosciences Building, Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, OX3 7JX, UK. phil.cowen@psych.ox.ac.uk.'}]",Psychopharmacology,['10.1007/s00213-020-05654-1']
1975,32911138,"Short-term oral corticosteroids for initial treatment of moderate-to-severe persistent asthma: A double-blind, randomized, placebo-controlled trial.","BACKGROUND AND PURPOSE
The purpose of this study was to investigate that on the basis of ICS-LABA treatment, whether or not adding on short course of oral corticosteroid could increase the rate of asthma control.
METHODOLOGY
This was a double blind, randomized controlled study. Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic. All patients included in the study received ICS-LABA as initial treatment. Two weeks oral corticosteroid or placebo were added on at the beginning of treatment. All the subjects were followed-up by daily measurement of PEF and asthma diary for 12 week and spirometry at 4 weeks and 12 weeks.
RESULTS
13 cases were randomized to Corticosteroid group (M/F: 9/4, age: 45.0 ± 5.0 yrs), 11 to Placebo group (M/F: 4/7, age: 35.7 ± 9.6yrs). After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05). However, there were no significant difference between two groups in the improvement of ACT、ACQ、AQLQ、FEV1、FEV1% (all P > 0.05). After 4 weeks of treatment, total control was achieved in 3 (30.8%) in corticosteroid group and 2 (18.2%) in placebo group; Partial control was achieved in 7 (61.5%)in corticosteroid group and in 7 (63.6%) in placebo group. There was no significant difference in control rates between two groups (X 2 = 0.919, P = 0.632). Similar findings were observed after 12 weeks of treatment.
CONCLUSION
In maintenance treatment naïve moderate to severe persistent asthma, ICS-LABA therapy was adequate initial treatment for achieving asthma control in majority of the patients. Add on short course of oral corticosteroid provided no significant clinical benefit.",2020,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","['moderate-to-severe persistent asthma', '13 cases', 'Patients with moderate to severe persistent asthma who are maintenance treatment naïve were recruited from the out-patients clinic']","['Short-term oral corticosteroids', 'corticosteroid or placebo', 'placebo', 'ICS-LABA', 'Corticosteroid', 'Placebo']","['total control', 'control rates', 'rate of asthma control']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",13.0,0.251154,"After treatment, significant improvement in ACT、ACQ、AQLQ、FEV1、FEV1% were observed in both groups as compared with baseline data (all P < 0.05).","[{'ForeName': 'Yihua', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Guangzhou Red Cross Hospital, Medical College, Jinan University, Guangzhou, China.'}, {'ForeName': 'Dongming', 'Initials': 'D', 'LastName': 'Hua', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Liao', 'Affiliation': 'Guangzhou Overseas Chinese Hospital, China.'}, {'ForeName': 'Rongchang', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University (National Clinical Research Center for Respiratory Diseases), Guangzhou, China. Electronic address: chenrc@vip.163.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106126']
1976,32911474,Fluoride Varnish in Nursery Schools: A Randomised Controlled Trial - Protecting Teeth @3.,"Studies suggest that fluoride varnish (FV) application can reduce dental caries in child populations. The multiple-component national child oral health improvement programme in Scotland (Childsmile) includes nursery-based universal supervised toothbrushing and deprivation-targeted FV applications, together with community and dental practice prevention interventions. This trial, a double-blind, two-arm randomised control trial, aimed to assess the effectiveness and cost-effectiveness of the nursery-based FV applications plus treatment-as-usual (TAU) Childsmile programme interventions, compared to TAU Childsmile interventions alone, in children not targeted to receive nursery FV as part of the programme. Participating children in the first year of nursery (aged three), with or without existing caries, were randomised to either FV or TAU and followed up for 24 months until the first year of primary school. Treatments were administered at six-monthly intervals. The primary endpoint was ""worsening of d3mft"" from baseline to 24 months. Secondary endpoints were worsening of d3mfs, d3t, mt, and ft. Individual record-linkage captured wider programme activities and tertiary endpoints. A total of 1,284 children were randomised, leading to 1,150 evaluable children (n = 577 FV, n = 573 TAU, 10% dropouts). Mean age was 3.5 years, 50% were female (n = 576), 17% had caries at baseline (n = 195), all balanced between the groups. Most children received three/four treatments. Overall, 26.9% (n = 155) had worsened d3mft in the FV group, and 31.6% (n = 181) in the TAU group, with an odds ratio (OR) of 0.80 (0.62-1.03), p = 0.078. The results for worsening of the secondary endpoints were: d3mfs 0.79 (0.61-1.01) p = 0.063, d3t 0.75 (0.57-0.99) p = 0.043, mt 1.34 (0.75-2.39) p = 0.319, and ft 0.77 (0.53-1.14) p = 0.191. We calculated a number needed to treat of 21 and a cost of GBP 686 to prevent a single worsening of d3mft. There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.",2020,"There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.","['1,284 children were randomised, leading to 1,150 evaluable children (n = 577 FV, n = 573', 'children not targeted to receive nursery FV as part of the programme', 'Nursery Schools', 'child populations', 'Mean age was 3.5 years, 50% were female (n = 576), 17% had caries at baseline (n = 195), all balanced between the groups', 'Participating children in the first year of nursery (aged three), with or without existing caries']","['FV or TAU', 'fluoride varnish (FV) application', 'Fluoride Varnish', 'nursery-based FV applications plus treatment-as-usual (TAU) Childsmile programme interventions']","['effectiveness and cost-effectiveness', 'worsening of d3mft', 'worsening of d3mfs, d3t, mt, and ft']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0036379', 'cui_str': 'Nursery school'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0028659', 'cui_str': 'Nurseries'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]",1284.0,0.209769,"There was a modest non-significant reduction in the worsening of d3mft in the nursery FV group compared to TAU, suggesting that this intervention is unlikely to represent an effective or cost-effective addition to the population oral health improvement programme.","[{'ForeName': 'Alex D', 'Initials': 'AD', 'LastName': 'McMahon', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom, alex.mcmahon@glasgow.ac.uk.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wright', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Anopa', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'McIntosh', 'Affiliation': 'Health Economic and Health Technology Assessment, Institute of Health and Wellbeing (MVLS), University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Turner', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Conway', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}, {'ForeName': 'Lorna M D', 'Initials': 'LMD', 'LastName': 'Macpherson', 'Affiliation': 'Community Oral Health, University of Glasgow Dental School (MVLS), Glasgow, United Kingdom.'}]",Caries research,['10.1159/000509680']
1977,32918588,Intra-individual physiological response of recreational runners to different training mesocycles: a randomized cross-over study.,"PURPOSE
Pronounced differences in individual physiological adaptation may occur following various training mesocycles in runners. Here we aimed to assess the individual changes in performance and physiological adaptation of recreational runners performing mesocycles with different intensity, duration and frequency.
METHODS
Employing a randomized cross-over design, the intra-individual physiological responses [i.e., peak ([Formula: see text]) and submaximal ([Formula: see text]) oxygen uptake, velocity at lactate thresholds (V 2 , V 4 )] and performance (time-to-exhaustion (TTE)) of 13 recreational runners who performed three 3-week sessions of high-intensity interval training (HIIT), high-volume low-intensity training (HVLIT) or more but shorter sessions of HVLIT (high-frequency training; HFT) were assessed.
RESULTS
[Formula: see text], V 2, V 4 and TTE were not altered by HIIT, HVLIT or HFT (p > 0.05). [Formula: see text] improved to the same extent following HVLIT (p = 0.045) and HFT (p = 0.02). The number of moderately negative responders was higher following HIIT (15.4%); and HFT (15.4%) than HVLIT (7.6%). The number of very positive responders was higher following HVLIT (38.5%) than HFT (23%) or HIIT (7.7%). 46% of the runners responded positively to two mesocycles, while 23% did not respond to any.
CONCLUSION
On a group level, none of the interventions altered [Formula: see text], V 2 , V 4 or TTE, while HVLIT and HFT improved [Formula: see text]. The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT. 46% responded positively to two mesocycles, while 23% did not respond to any. These findings indicate that the magnitude of responses to HIIT, HVLIT and HFT is highly individual and no pattern was apparent.",2020,"The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT.","['recreational runners to different training mesocycles', '13 recreational runners', 'runners']","['high-intensity interval training (HIIT), high-volume low-intensity training (HVLIT) or more but shorter sessions of HVLIT (high-frequency training; HFT', 'submaximal ([Formula: see text]) oxygen uptake, velocity at lactate thresholds (V 2 , V 4 )] and performance (time-to-exhaustion (TTE']","['mean adaptation index', 'number of moderately negative responders', 'number of very positive responders']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0445362', 'cui_str': 'V 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0430462', 'cui_str': 'Transthoracic echocardiography'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0365246,"The mean adaptation index indicated similar numbers of positive, negative and non-responders to HIIT, HVLIT and HFT, but more very positive responders to HVLIT than HFT or HIIT.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Düking', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany. Peter.dueking@uni-wuerzburg.de.'}, {'ForeName': 'Hans-Christer', 'Initials': 'HC', 'LastName': 'Holmberg', 'Affiliation': 'Swedish Winter Sports Research Centre, Department of Health Sciences, Mid Sweden University, Östersund, Sweden.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Kunz', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leppich', 'Affiliation': 'Chair of Software Engineering, Department of Computer Science, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Billy', 'Initials': 'B', 'LastName': 'Sperlich', 'Affiliation': 'Integrative and Experimental Exercise Science and Training, Department of Sport Science, University of Würzburg, Würzburg, Germany.'}]",European journal of applied physiology,['10.1007/s00421-020-04477-4']
1978,32920297,Postprandial factor VII activation does not increase plasma concentrations of prothrombin fragment 1 + 2 in patients with morbid obesity.,"INTRODUCTION
Increased postprandial factor VII activation is observed after high-fat meals, but is not accompanied by thrombin formation in normal weight individuals. Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals. We therefore compared postprandial effects of high-fat meals and low-fat meals on biomarkers of coagulation activation in patients with morbid obesity and investigated whether the response was associated with the gut bacteria composition.
MATERIALS AND METHODS
A controlled cross-over study was conducted in obese patients (15 women, 5 men, mean BMI = 44.1 kg/m 2 ), where high-fat meals (67 E% fat) and low-fat meals (16 E% fat) were served at 8:15 and 10:00 in a random order on two study days within one week. Blood samples were collected at 08:00 (fasting), 12:00, and 14:00 and analysed for triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1 + 2 (F1+2), and TF pathway inhibitor (TFPI). The gut bacteria composition, measured as gram-negative bacteria and diversity, was analysed in faecal samples.
RESULTS
Triglycerides, FVIIa, and FVIIa-AT increased significantly after high-fat meals, whereas F1 + 2 decreased equally and significantly over time after both meals. There were no significant changes in TF and TFPI over time. The postprandial changes in F1 + 2 and TFPI after high-fat meals were negatively correlated with diversity.
CONCLUSIONS
Increased postprandial FVIIa is not accompanied by thrombin formation four hours after high-fat meals in patients with morbid obesity, possibly due to FVIIa-inhibition by AT.",2020,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","['patients with morbid obesity', 'obese patients (15 women, 5 men, mean BMI\xa0', 'normal weight individuals']",['high-fat meals and low-fat meals'],"['Triglycerides, FVIIa, and FVIIa-AT', 'triglycerides, activated FVII (FVIIa), TF, FVIIa-antithrombin (FVIIa-AT), prothrombin fragment 1\xa0+\xa02 (F1+2), and TF pathway inhibitor (TFPI', 'Blood samples', 'postprandial changes', 'gut bacteria composition', 'TF and TFPI', 'thrombin formation', 'circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0040048', 'cui_str': 'Thromboplastin'}, {'cui': 'C0072436', 'cui_str': 'Prothrombin fragment 1.2'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023810', 'cui_str': 'Lipopolysaccharide'}]",,0.0190304,"Obesity is associated with a higher circulating concentration of tissue factor (TF) and postprandial uptake of lipopolysaccharide (LPS), and this may increase thrombin formation after high-fat meals.","[{'ForeName': 'Line Espenhain', 'Initials': 'LE', 'LastName': 'Landgrebe', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark; OPEN, Odense Patient data Explorative Network, Odense University Hospital, Odense, Denmark. Electronic address: Line.Espenhain.Landgrebe@rsyd.dk.'}, {'ForeName': 'Claus Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Department of Medicine, Section of Endocrinology, University Hospital of Southern Denmark, Esbjerg, Denmark; Steno Diabetes Center Odense, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Department of Regional Health Research, University of Southern Denmark, Denmark; Focused Research Unit for Molecular Diagnostic and Clinical Research, University Hospital of Southern Denmark, Aabenraa, Denmark; Institute of Molecular Medicine, University of Southern Denmark, Denmark.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Moitinho-Silva', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany; Department of Dermatology, Venereology and Allergy, University Hospital Schleswig-Holstein, Campus Kiel, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bang', 'Affiliation': 'Institute of Clinical Molecular Biology, Christian-Albrechts-University of Kiel, Kiel, Germany.'}, {'ForeName': 'Else Marie', 'Initials': 'EM', 'LastName': 'Bladbjerg', 'Affiliation': 'Unit for Thrombosis Research, Department of Clinical Biochemistry, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.08.044']
1979,32920321,Effects of cerebellar transcranial magnetic stimulation on ataxias: A randomized trial.,"INTRODUCTION
Cerebellar ataxia remains a neurological symptom orphan of treatment interventions, despite being prevalent and incapacitating. We aimed to study, in a double-blind design, whether cerebellar modulation could improve ataxia.
METHODS
We included patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia. Patients received five sessions each of sham and active cerebellar 1 Hz deep repetitive transcranial magnetic stimulation in randomized order. Our primary outcome was the decrease in the Scale for the Assessment and Rating of Ataxia when comparing phases (active x sham). Secondary outcomes measures included the International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales. This study was registered at clinicaltrials.gov (protocol NCT03213106).
RESULTS
Twenty-four patients aged 29-74 years were included in our trial. After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002]. The International Cooperative Ataxia Rating Scale score also improved after active stimulation versus sham [median (interquartile range) of 29.0 (21.0, 43.5) versus 32.8 (22.0, 47.0); p = 0.005]. Other secondary outcomes were not significantly modified by stimulation. No patient presented severe side effects, and nine presented mild and self-limited symptoms.
CONCLUSIONS
Our protocol was safe and well-tolerated. These findings suggest that cerebellar modulation may improve ataxic symptom and provide reassurance about safety for clinical practice.",2020,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","['ataxias', 'Twenty-four patients aged 29-74 years', 'patients with diagnosis of spinocerebellar ataxia type 3, multiple systems atrophy cerebellar type, or post-lesion ataxia']","['Hz deep repetitive transcranial magnetic stimulation', 'cerebellar transcranial magnetic stimulation']","['International Cooperative Ataxia Rating Scale score', 'ataxia', 'ataxic symptom', 'severe side effects', 'International Cooperative Ataxia Rating Scale, and other motor, cognitive, and quality of life scales', 'safe and well-tolerated', 'Scale for the Assessment and Rating of Ataxia', 'Scale for the Assessment and Rating of Ataxia score']","[{'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0024408', 'cui_str': 'Azorean disease'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C4760996', 'cui_str': 'International cooperative ataxia rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004134', 'cui_str': 'Ataxia'}, {'cui': 'C0234366', 'cui_str': 'Ataxic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C4760258', 'cui_str': 'Ataxia assessment scale'}]",24.0,0.653213,"After active stimulation, the Scale for the Assessment and Rating of Ataxia score was significantly lower than the score after sham stimulation [median (interquartile range) of 10.2 (6.2, 16.2) versus 12.8 (9.6, 17.8); p = 0.002].","[{'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'França', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'de Andrade', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Valquíria', 'Initials': 'V', 'LastName': 'Silva', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Galhardoni', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Egberto R', 'Initials': 'ER', 'LastName': 'Barbosa', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Manoel J', 'Initials': 'MJ', 'LastName': 'Teixeira', 'Affiliation': 'Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil; Functional Neurosurgery Division, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rubens G', 'Initials': 'RG', 'LastName': 'Cury', 'Affiliation': 'Movement Disorders Center, LIM 62, Department of Neurology, School of Medicine, University of São Paulo, São Paulo, Brazil; Service of Interdisciplinary Neuromodulation (SIN), Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of São Paulo, São Paulo, Brazil. Electronic address: rubens_cury@usp.br.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.001']
1980,32920492,A randomized-controlled trial of blonanserin and olanzapine as adjunct to antipsychotics in the treatment of patients with schizophrenia and dopamine supersensitivity psychosis: The ROADS study.,"Dopamine supersensitivity psychosis (DSP) is a key factor contributing to the development of antipsychotic treatment-resistant schizophrenia. We examined the efficacy and safety of blonanserin (BNS) and olanzapine (OLZ) as adjuncts to prior antipsychotic treatment in patients with schizophrenia and DSP in a 24-week, multicenter (17 sites), randomized, rater-blinded study with two parallel groups (BNS and OLZ add-on treatments) in patients with schizophrenia and DSP: the ROADS Study. The primary outcome was the change in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 24. Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses. The 61 assessed patients were allocated into a BNS group (n = 26) and an OLZ group (n = 29). The PANSS total scores were reduced in both groups (mean ± SD: -14.8 ± 24.0, p = 0.0042; -10.5 ± 12.9, p = 0.0003; respectively) with no significant between-group difference (mean, -4.3, 95 %CI 15.1-6.4, p = 0.42). The BNS group showed significant reductions from week 4; the OLZ group showed significant reductions from week 8. The ESRS scores were reduced in the BNS group and the others were reduced in both groups. The antipsychotic monotherapy rates at the endpoint were 26.3 % (n = 6) for BNS and 23.8 % (n = 5) for OLZ. The concomitant antipsychotic doses were reduced in both groups with good tolerability. Our results suggest that augmentations with BNS and OLZ are antipsychotic treatment options for DSP patients, and BNS may be favorable for DSP based on the relatively quick responses to BNS observed herein.",2020,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","['patients with schizophrenia and dopamine supersensitivity psychosis', 'Dopamine supersensitivity psychosis (DSP', 'patients with schizophrenia and DSP in a 24-week, multicenter (17 sites', 'patients with schizophrenia and DSP']","['BNS', 'OLZ', 'antipsychotics', 'blonanserin (BNS) and olanzapine (OLZ', 'blonanserin and olanzapine']","['PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses', 'antipsychotic monotherapy rates', 'change in the Positive and Negative Syndrome Scale (PANSS) total score', 'ESRS scores', 'PANSS total scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0187611,"Secondary outcomes were changes in the PANSS subscale scores, Clinical Global Impressions, and Extrapyramidal Symptom Rating Scale (ESRS), and changes in antipsychotic doses.","[{'ForeName': 'Tomihisa', 'Initials': 'T', 'LastName': 'Niitsu', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan. Electronic address: niitsu@chiba-u.jp.'}, {'ForeName': 'Tatsuki', 'Initials': 'T', 'LastName': 'Hata', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Fujita Hospital, Sosa, Chiba, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Nishimoto', 'Affiliation': 'Soshu Hospital, Atsugi, Kanagawa, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Hosoda', 'Affiliation': 'Fujita Hospital, Sosa, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Oda', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Suzuki', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'Mobara Mental Hospital, Mobara, Chiba, Japan.'}, {'ForeName': 'Ryota', 'Initials': 'R', 'LastName': 'Seki', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Chiba Hospital, Funabashi, Chiba, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Okehazama Hospital Fujita Kokoro Care Center, Toyoake, Aichi, Japan.'}, {'ForeName': 'Mitsugu', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Asai Hospital, Togane, Chiba, Japan.'}, {'ForeName': 'Taisuke', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Kisatazu Hospital, Kisarazu, Chiba, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Inoue', 'Affiliation': 'Katsushikabashi Hospital, Tokyo, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Hattori', 'Affiliation': 'Johmoh Hospital, Maebashi, Gunma, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Sanmaibashi Hospital, Ota, Gunma, Japan.'}, {'ForeName': 'Yukitsugu', 'Initials': 'Y', 'LastName': 'Imamura', 'Affiliation': 'Department of Neuropsychiatry, Asahi General Hospital, Asahi, Chiba, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Yowa Hospital, Tokyo, Japan; Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Goro', 'Initials': 'G', 'LastName': 'Fukami', 'Affiliation': 'Chiba Psychiatric Medical Center, Chiba, Japan.'}, {'ForeName': 'Takatoshi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Project Leader Office, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Biostatistics Section, Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Sodegaura-Satsukidai Hospital, Sodegaura, Chiba, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiina', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Kanahara', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': 'Masaomi', 'Initials': 'M', 'LastName': 'Iyo', 'Affiliation': 'Department of Psychiatry, Chiba University Graduate School of Medicine, Chiba, Japan; Child Psychiatry, Chiba University Hospital, Chiba, Japan; Division of Medical Treatment and Rehabilitation, Center for Forensic Mental Health, Chiba University, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102369']
1981,32929822,Effectiveness of patient-oriented education and medication management intervention in people with decompensated cirrhosis.,"People with chronic disease often have poor comprehension of their disease and medications, which can negatively affect health outcomes. In a randomised-controlled trial, we found that patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n = 57) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n = 59). Intervention patients also experienced improved quality of life. Dedicated resources are needed to support implementation of evidence-based measures at local centres to improve outcomes.",2020,Intervention patients also experienced improved quality of life.,"['people with decompensated cirrhosis', 'patients with decompensated cirrhosis who received a pharmacist-led, patient-oriented education and medication management intervention (n =\u200957) had greater knowledge of cirrhosis and key self-care tasks compared with usual care (n =\u200959', 'People with chronic disease']",['patient-oriented education and medication management intervention'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.102154,Intervention patients also experienced improved quality of life.,"[{'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Hayward', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'Valery', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Preya J', 'Initials': 'PJ', 'LastName': 'Patel', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Leigh U', 'Initials': 'LU', 'LastName': 'Horsfall', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Penny L', 'Initials': 'PL', 'LastName': 'Wright', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Tallis', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Stuart', 'Affiliation': 'Department of Gastroenterology and Hepatology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'David', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Irvine', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'W Neil', 'Initials': 'WN', 'LastName': 'Cottrell', 'Affiliation': 'Macrophage Biology Research Group, Mater Research, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Jennifer H', 'Initials': 'JH', 'LastName': 'Martin', 'Affiliation': 'Centre for Human Drug Research, School of Medicine and Public Health, Hunter Medical Research Institute, The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Powell', 'Affiliation': 'Centre for Liver Disease Research, Faculty of Medicine, Translational Research Institute, The University of Queensland, Brisbane, Queensland, Australia.'}]",Internal medicine journal,['10.1111/imj.14986']
1982,32949786,Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1-6 in Brazil.,"INTRODUCTION AND OBJECTIVES
Glecaprevir/pibrentasvir is a highly effective and well tolerated treatment for hepatitis C infection. Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir. This study aimed to assess safety and efficacy of glecaprevir/pibrentasvir in treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis.
PATIENTS AND METHODS
EXPEDITION-3 was a Phase 3, open-label, multicenter study in treatment-naïve Brazilian adults with hepatitis C infection genotype 1-6. Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4) received 8 or 12 weeks of glecaprevir/pibrentasvir, respectively. The primary efficacy endpoint was the rate of sustained virologic response at post-treatment Week 12. Secondary endpoints were on-treatment virologic failure and relapse rates. Baseline polymorphisms were assessed in NS3 and NS5A. Adverse events and laboratory abnormalities were monitored.
RESULTS
100 patients were enrolled, 75 received 8 weeks of treatment and 25 received 12 weeks; all patients completed treatment. Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100; 95% confidence interval: 93.0-99.4) and remained high regardless of baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities. 55% of patients reported ≥1 adverse event, the most common being headache (18.0%). Four patients reported serious adverse events; none were considered drug related or led to study drug discontinuation. No hepatic decompensations were observed.
CONCLUSIONS
Glecaprevir/pibrentasvir was effective and well tolerated in treatment-naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03219216.",2020,Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100;,"['naïve Brazilian patients with hepatitis C infection without cirrhosis and with compensated cirrhosis', 'Treatment-Naïve Adults with Chronic Hepatitis C Virus Genotypes 1-6 in Brazil', 'treatment-naïve Brazilian adults without cirrhosis or with compensated cirrhosis', 'naïve Brazilian adults with hepatitis C infection genotype 1-6', '100 patients', 'Patients without cirrhosis (F2 or F3) or with compensated cirrhosis (F4', 'Brazilian patients were not included in the original development studies for glecaprevir/pibrentasvir']","['glecaprevir/pibrentasvir', 'Glecaprevir/Pibrentasvir', 'Glecaprevir/pibrentasvir']","['effective and well tolerated', 'treatment virologic failure and relapse rates', 'safety and efficacy', 'Efficacy and Safety', 'baseline viral or host factors, including demographics, hepatitis C virus RNA levels, polymorphisms in NS3 and/or NS5A, genotype, and relevant comorbidities', 'rate of sustained virologic response', 'hepatic decompensations', 'NS3 and NS5A. Adverse events and laboratory abnormalities', 'Overall sustained virologic response', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}]","[{'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1699206', 'cui_str': 'Virologic failure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C1394798', 'cui_str': 'Hepatic decompensation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",100.0,0.0808733,Overall sustained virologic response at post-treatment Week 12 rate was high (98.0%; 98/100;,"[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Peribañez-Gonzalez', 'Affiliation': 'Hospital Dia, Av Dr Arnaldo, 165, Segundo andar, São Paulo, Brazil. Electronic address: mpgonzalez@terra.com.br.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cheinquer', 'Affiliation': 'Ramiro Barcelos 2350, CPC Sala, 21216, Porto Alegre, Brazil. Electronic address: drhugo@terra.com.br.'}, {'ForeName': 'Lino', 'Initials': 'L', 'LastName': 'Rodrigues', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: lino.rodrigues@abbvie.com.'}, {'ForeName': 'Maria Patelli', 'Initials': 'MP', 'LastName': 'Lima', 'Affiliation': 'Instituto de Infectologia Campinas, Rua Dr. Quirino, 524, Sala 72, Centro, Campinas, Brazil. Electronic address: mariapatelli@uol.com.br.'}, {'ForeName': 'Mário Reis', 'Initials': 'MR', 'LastName': 'Álvares-da-Silva', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, GI/Liver Division, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: marioreis@live.com.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Madruga', 'Affiliation': 'Rua Santa Cruz, 81, Vila Mariana, São Paulo, Brazil. Electronic address: valdezmr@uol.com.br.'}, {'ForeName': 'Edison Roberto', 'Initials': 'ER', 'LastName': 'Parise', 'Affiliation': 'Rua Diogo de Faria, 816 - Vila Clementino, São Paulo, Brazil. Electronic address: parise@sbhepatologia.org.br.'}, {'ForeName': 'Mário Guimarães', 'Initials': 'MG', 'LastName': 'Pessoa', 'Affiliation': 'Division of Gastroenterology and Hepatology University of São Paulo School of Medicine, Avenida Enéas de Carvalho Aguiar, 255 - Bloco B - 4º andar, São Paulo, Brazil. Electronic address: mgpessoa@uol.com.br.'}, {'ForeName': 'Juvencio', 'Initials': 'J', 'LastName': 'Furtado', 'Affiliation': 'Rua Cônego Xavier, 276 - Amb de Infectologia, São Paulo, Brazil. Electronic address: juvencio.furtado@terra.com.br.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Villanova', 'Affiliation': 'Hospital das ClÍnicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Campus Universitário s/n, Monte Alegre, Bloco G Subsolo 2, Unidade de Pesquisa Clinica, Ribeirão Preto, Brazil. Electronic address: marciagvillanova@gmail.com.'}, {'ForeName': 'Adalgisa', 'Initials': 'A', 'LastName': 'Ferreira', 'Affiliation': 'Centro de Pesquisa Clínica Hospital Universitario da Universidade Federal do Maranhão, Rua Almirante Tamandaré, 01. Centro, São Luís, Brazil. Electronic address: adalgisaf@terra.com.br.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Mazzoleni', 'Affiliation': 'Hospital Ernesto Dornelles, Av. Ipiranga 1801, 7ºAndar, Cpda-Pesquisa, Porto Alegre, Brazil. Electronic address: fimazzoleni@hotmail.com.'}, {'ForeName': 'Ecio', 'Initials': 'E', 'LastName': 'Nascimento', 'Affiliation': 'Av. Mandacaru, 1590, Maringá, Brazil. Electronic address: eanascimento@uem.br.'}, {'ForeName': 'Giovanni Faria', 'Initials': 'GF', 'LastName': 'Silva', 'Affiliation': 'Unesp Campus de Botucatu, Rua Prof Dr Armanda Alves, s/n(0) Bairro: Botucatu, Brazil. Electronic address: Giovanni.f.silva@unesp.br.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Fredrick', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: linda.m.fredrick@abbvie.com.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: Preethi.krishnan@abbvie.com.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Burroughs', 'Affiliation': 'AbbVie Inc., North Chicago, IL, USA. Electronic address: Margaret.burroughs@abbvie.com.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Reuter', 'Affiliation': 'Marechal Campos Av. 1355, Outclinic number 5, Vitoria, Brazil. Electronic address: tania.reuter@gmail.com.'}]",Annals of hepatology,['10.1016/j.aohep.2020.09.002']
1983,32950505,Social media use while listening to new material negatively affects short-term memory in college students.,"Increased access to electronic devices and the ubiquity of social media has resulted in a rapid rise in the prevalence of students ""multitasking"" while in a classroom setting. While some data indicate the use of electronic devices in class can improve the classroom environment, other studies demonstrate the opposite finding. Moreover, it remains unclear if using social networking sites such as Instagram impacts performance on cognitive tasks when students are presented new material and, if so, what features of Instagram modulate this response. Therefore, in the current study we examined if social media use during or after being presented new information affected short-term memory in college students. Additionally, we assessed if the type or quantity of topics displayed had a modulatory impact on memory. Forty-five college-aged (18-24 years of age) students completed the Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory. Subjects were randomly divided into a group that completed the LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM I after scrolling through their Instagram feed. Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01). Recall ability in the group that used Instagram after hearing the story was not statistically different from the controls. Differences were not observed in the number of topics appearing in subjects' Instagram feeds and no correlation was found between the number of topics on a subject's Instagram feed and memory recall ability. Collectively, these results suggest that individuals who use their phones to browse Instagram during class or in social settings might have a reduced ability to retain the information given to them when compared to those that are not using their phones scrolling on social media.",2020,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"['Forty-five college-aged (18-24 years of age', 'college students', 'College Students']","['LM I without distraction (controls), a group that completed the LM I while scrolling through their Instagram feed, or a group that completed the LM']","['Logical Memory Immediate Recall (LM I) component of the Wechsler Memory Scale IV, a measure of auditory recognition memory', 'Recall ability', 'short-term memory recall ability']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.024727,Subjects that used Instagram while being presented new information demonstrated worse short-term memory recall ability compared to subjects that did not use Instagram during the presentation (71.56% correct answers vs. 80.89%; p = 0.01).,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Spence', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Kierian', 'Initials': 'K', 'LastName': 'Beasley', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gravenkemper', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hoefler', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ngo', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ortiz', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Campisi', 'Affiliation': 'Department of Biology, D-8, Regis University, Denver, CO 80221, USA. Electronic address: jcampisi@regis.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113172']
1984,31264493,Myosteatosis in adolescents and young adults treated for acute lymphoblastic leukemia.,"Myosteatosis refers to fat deposition within muscle and is linked to risk of cardiovascular disease and metabolic disorders. Though these comorbidities are common during and after therapy for acute lymphoblastic leukemia (ALL), little is known about tissue distribution, including myosteatosis, in this population. Using quantitative computed tomography, we assessed the impact of ALL therapy on bone, muscle, subcutaneous, and muscle-associated (MA) fat in 12 adolescents and young adults (AYA) treated for ALL as compared to a healthy control group without ALL ( n = 116). AYA had a marked loss of muscle with a gain in MA fat between ALL diagnosis and end of induction. These changes persisted throughout intensive therapy. Lower bone and muscle and higher MA fat were also observed during and after treatment in comparison to controls. Altered lower extremity tissue distribution, specifically myosteatosis and sarcopenia, may contribute to functional declines and increased risk of metabolic disorders and cardiovascular diseases.",2019,Lower bone and muscle and higher MA fat were also observed during and after treatment in comparison to controls.,"['adolescents and young adults treated for acute lymphoblastic leukemia', 'acute lymphoblastic leukemia (ALL', '12 adolescents and young adults (AYA) treated for ALL as compared to a healthy control group without ALL ( n \u2009=\u2009116']",[],"['bone, muscle, subcutaneous, and muscle-associated (MA) fat', 'Lower bone and muscle and higher MA fat']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}]",[],"[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0181417,Lower bone and muscle and higher MA fat were also observed during and after treatment in comparison to controls.,"[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Mueske', 'Affiliation': ""Children's Orthopaedic Center, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Mittelman', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Tishya A L', 'Initials': 'TAL', 'LastName': 'Wren', 'Affiliation': ""Children's Orthopaedic Center, Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Gilsanz', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Etan', 'Initials': 'E', 'LastName': 'Orgel', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1623889']
1985,32916132,The Impact of Prior Use of Corticosteroid to Dental Extraction on Oral Health-Related Quality-of-Life and Clinical Outcomes: A Randomized Clinical Trial.,"PURPOSE
To evaluate the impact of prior use of corticosteroids before dental extractions on oral health-related quality-of-life (OHRQoL).
METHODS
A randomized and triple-blind (patient, surgeon, and examiner) clinical trial was designed. The individuals were randomly allocated to 2 groups: test and placebo. In the test group, 2 capsules of 4 mg dexamethasone were administered orally. In the placebo group, subjects received 2 capsules with the same characteristics. In both groups, the administration took place 1 hour before the procedure. OHRQoL was assessed by the Brazilian version of Oral Health Impact Profile 14 (OHIP-14). The OHIP-14 questionnaire and the assessment methods for clinical parameters were collected preoperatively and postoperatively. Multilevel linear regression models fitted the associations between preoperative use of corticosteroids and overall and domain-specific OHIP-14 scores over time.
RESULTS
One hundred fourteen patients were selected for the study; however, 21 were excluded for not returning to postoperative control on the seventh day, resulting in 93 patients assessed (test = 44 and placebo = 49). The pain had a negative impact on OHRQoL (P < .01); however, the use of the drug had no statistically significant influence on OHRQoL (P = .62) and the clinical outcomes of pain (P = .63), mouth aperture (P = .05), and edema (P = .69).
CONCLUSIONS
The use of the 8 mg dexamethasone administered orally before the procedure was not effective on the improvement of the quality-of-life of patients undergoing dental extraction. However, using the medication seems to result in an improvement in the postoperative period of patients who had impacted teeth. Further research involving the analysis of OHRQoL must be performed, and other dosages and means of administration must be tested.",2020,The pain had a negative impact on OHRQoL,"['One hundred fourteen patients were selected for study; however, 21 were excluded for not returning to postoperative control on the seventh day, resulting in 93 patients assessed (test\xa0=\xa044 and placebo\xa0=\xa049', 'patients undergoing dental extraction']","['dexamethasone', 'placebo', 'OHRQoL', 'Corticosteroid to Dental Extraction']","['oral health-related quality of life (OHRQoL', 'OHRQoL', 'clinical outcomes of pain', 'Oral Health-Related Quality of Life and Clinical Outcomes', 'Brazilian version of Oral Health Impact Profile (OHIP-14', 'OHIP-14 questionnaire', 'quality of life', 'edema', 'mouth aperture']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",114.0,0.1098,The pain had a negative impact on OHRQoL,"[{'ForeName': 'Heitor B', 'Initials': 'HB', 'LastName': 'Pansard', 'Affiliation': ""MD Student, Health and Life Sciences Master's Student by the Franciscan University (UFN), Santa Maria, RS, Brazil.""}, {'ForeName': 'Mayara C', 'Initials': 'MC', 'LastName': 'Prado', 'Affiliation': ""MD Student, Health and Life Sciences Master's Student by the Franciscan University (UFN), Santa Maria, RS, Brazil.""}, {'ForeName': 'Gabriel F', 'Initials': 'GF', 'LastName': 'Marchi', 'Affiliation': 'Private Practitioner, Specialist in Bucco Maxillofacial Surgery and Traumatology, Santa Maria, RS, Brazil.'}, {'ForeName': 'Camila S', 'Initials': 'CS', 'LastName': 'Sfreddo', 'Affiliation': 'Professor, Dental School Professor of the Franciscan University (UFN), Santa Maria, RS, Brazil.'}, {'ForeName': 'Jovito A', 'Initials': 'JA', 'LastName': 'Skupien', 'Affiliation': ""Department Head, Health and Life Sciences Master's and Dental School of the Franciscan University (UFN), Santa Maria, RS, Brazil. Electronic address: skupien.ja@gmail.com.""}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.08.013']
1986,32919912,Associations Between Depressive Symptoms and HFpEF-Related Outcomes.,"OBJECTIVES
This study analyzed changes in depressive symptoms in patients with heart failure and preserved ejection fraction (HFpEF) who were enrolled in the TOPCAT (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function) trial.
BACKGROUND
There are limited longitudinal data for depressive symptoms in patients with HFpEF.
METHODS
In patients enrolled in the United States and Canada (n = 1,431), depressive symptoms were measured using Patient Health Questionnaire-9 (PHQ-9). Clinically meaningful changes in PHQ-9 scores were defined as worse (≥3-point increase) or better (≥3-point decrease). Multivariate models were used to identify predictors of change in depressive symptoms. Cox proportional hazard models were used to determine the impact of symptom changes from baseline on subsequent incident cardiovascular events.
RESULTS
At 12 months, 19% of patients experienced clinically worsening depressive symptoms, 31% better, and 49% unchanged. Independent predictors of clinically meaningful improvement in depressive symptoms included higher baseline PHQ-9 scores, male sex, lack of chronic obstructive pulmonary disease, and randomization to spironolactone. After data were adjusted for cardiovascular comorbidities, higher baseline PHQ-9 was associated with all-cause mortality (hazard ratio [HR]: 1.09; 95% confidence interval [CI]: 1.02 to 1.16; p = 0.011), whereas worsening depressive symptoms at 12 months were associated with cardiovascular death (HR: 2.47; 95% CI: 1.32 to 4.63; p = 0.005) and all-cause mortality (HR: 1.82; 95% CI: 1.13 to 2.93; p = 0.014). Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
CONCLUSIONS
Higher baseline depressive symptoms and worsening depressive symptoms were associated with all-cause mortality. Randomization to spironolactone was associated with modest reduction in depressive symptoms. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302).",2020,"Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
","['patients with HFpEF', 'patients with heart failure and preserved ejection fraction (HFpEF) who were enrolled in the', 'for Adults With Heart\xa0Failure and Preserved Systolic Function) trial']","['Aldosterone Antagonist Therapy', 'TOPCAT (Aldosterone Antagonist Therapy', 'spironolactone']","['baseline PHQ-9 scores, male sex, lack of chronic obstructive pulmonary disease', 'baseline depressive symptoms and worsening depressive symptoms', 'clinically worsening depressive symptoms', 'depressive symptoms', 'PHQ-9 scores', 'cardiovascular death', 'worsening depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.485354,"Randomization to spironolactone was associated with modest but statistically significant reduction in depressive symptoms over the course of the trial (p = 0.014).
","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Chandra', 'Affiliation': 'Cardiology Division, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Michael A D', 'Initials': 'MAD', 'LastName': 'Alcala', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Fang', 'Affiliation': 'University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Heitner', 'Affiliation': 'New York Presbyterian-Brooklyn Methodist Hospital, New York, New York, USA.'}, {'ForeName': 'Jiankang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Eldrin F', 'Initials': 'EF', 'LastName': 'Lewis', 'Affiliation': 'Division of Cardiovascular Medicine, Stanford University School of Medicine, Palo Alto, California, USA. Electronic address: eflewis@stanford.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.010']
1987,32928659,Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix.,"BACKGROUND
Dyspareunia experienced by women diagnosed with endometriosis is associated with a decreased health-related quality of life (HRQoL).
AIM
We evaluated the relationship of clinically meaningful improvements in dyspareunia with HRQoL changes among women with endometriosis.
METHODS
This was a post hoc analysis of pooled data from the phase III ELARIS-I and ELARIS-II clinical trials. Women aged 18-49 years with moderate to severe endometriosis-associated pain were randomized to placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. HRQoL was measured using the validated Endometriosis Health Profile-30 questionnaire (EHP-30), consisting of 5 core domains and a sexual intercourse modular domain. Dyspareunia was ranked 0-3 (none, mild, moderate, or severe) or not applicable using a daily eDiary and averaged monthly. A woman with a clinically meaningful dyspareunia response (dyspareunia responder) was defined as a woman with a reduction from the baseline in dyspareunia score greater than or equal to a predetermined cutoff while maintaining stable/decreased analgesic use.
OUTCOMES
Dyspareunia response impact on EHP-30 scores was determined at 3 and 6 months using multivariate linear regression controlling for age, baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity.
RESULTS
Analysis included 1,368 women with a mean age of 32.2 years. Dyspareunia responders had significant improvements vs non-responders in all adjusted mean EHP-30 domain scores at months 3 and 6 (control and powerlessness: -17.8 and -18.5; emotional well-being: -10.0 and -10.4; pain: -15.3 and -15.7; self-image: -11.4 and -12.8; social support: -14.3 and -14.0; and sexual intercourse: -18.1 and -19.7; all P < .0001).
CLINICAL IMPLICATIONS
Dyspareunia improvements are associated with both personal and psychological benefits.
STRENGTHS & LIMITATIONS
This study involved a large sample of women from a well-defined patient population to provide statistical power in evaluating the results. As such, the findings may not be generalizable in a real-world setting. Although the perception of dyspareunia and its severity and the associated effect on HRQoL was subjective, the use of a large patient sample was used to minimize potential issues with this limitation.
CONCLUSION
Clinically meaningful responses in dyspareunia are associated with improvements across multiple HRQoL domains among women with endometriosis. Agarwal SK, Soliman AM, Pokrzywinski RM, et al. Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain Associated with Endometriosis: A Pooled Analysis of Two Phase III Trials of Elagolix. J Sex Med 2020;17:2427-2433.",2020,Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain,"['large sample of women from a well-defined patient population', '1,368 women with a mean age of 32.2\xa0years', 'Associated with Endometriosis', 'Women aged 18-49 years with moderate to severe endometriosis-associated pain', 'A woman with a clinically meaningful dyspareunia response (dyspareunia responder', 'Endometriosis', 'Women with Moderate to Severe Pain', 'women diagnosed with endometriosis', 'Women', 'women with endometriosis']","['placebo, elagolix 150\xa0mg once daily, or elagolix 200\xa0mg twice daily']","['dyspareunia with HRQoL changes', 'dyspareunia score', 'Dyspareunia', 'HRQoL', 'Health-Related Quality of Life', 'Severe Pain', 'Dyspareunia response impact on EHP-30 scores', 'baseline EHP-30 scores, and dysmenorrhea and non-menstrual pelvic pain symptom severity', 'Dyspareunia responders', 'mean EHP-30 domain scores']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442825', 'cui_str': 'Well defined'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704593', 'cui_str': 'elagolix 150 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",1368.0,0.13689,Clinically Meaningful Reduction in Dyspareunia Is Associated with Significant Improvements in Health-Related Quality of Life Among Women with Moderate to Severe Pain,"[{'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Agarwal', 'Affiliation': 'Center for Endometriosis Research and Treatment, University of California, San Diego, La Jolla, CA, USA. Electronic address: skagarwal@health.ucsd.edu.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'Health Economics and Outcomes Research, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'Global Pharmaceutical Research and Development, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.08.002']
1988,32930649,Comparing Screening Outcomes for Digital Breast Tomosynthesis and Digital Mammography by Automated Breast Density in a Randomized Controlled Trial: Results from the To-Be Trial.,"Background Digital breast tomosynthesis (DBT) is considered superior to digital mammography (DM) for women with dense breasts. Purpose To identify differences in screening outcomes, including rates of recall, false-positive (FP) findings, biopsy, cancer detection rate, positive predictive value of recalls and biopsies, and histopathologic tumor characteristics by density using DBT combined with two-dimensional synthetic mammography (SM) (hereafter, DBT+SM) versus DM. Materials and Methods This randomized controlled trial comparing DBT+SM and DM was performed in Bergen as part of BreastScreen Norway, 2016-2017. Automated software measured density (Volpara Density Grade [VDG], 1-4). The outcomes were compared for DBT+SM versus DM by VDG in descriptive analyses. A stratified log-binomial regression model was used to estimate relative risk of outcomes in subgroups by screening technique. Results Data included 28 749 women, 14 380 of whom were screened with DBT+SM and 14 369 of whom were screened with DM (both groups: median age, 59 years; interquartile range [IQR], 54-64 years). The recall rate was lower for women screened with DBT+SM versus those screened with DM for VDG 1 (2.1% [81 of 3929] vs 3.3% [106 of 3212]; P = .001) and VDG 2 (3.2% [200 of 6216] vs 4.3% [267 of 6280]; P = .002). For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8; P < .001; VDG 3: 2.4; P < .001; VDG 4: 1.8; P = .02) and screen-detected breast cancer (VDG 2: 2.4; P = .004; VDG 3: 2.8; P = .01; VDG 4: 2.8; P = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3; P = .06; VDG 3: 1.1; P = .41; VDG 4: 1.1; P = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7; P = .13; VDG 3: 2.1; P = .06; VDG 4: 2.2; P = .15). Conclusion Screening with digital breast tomosynthesis combined with synthetic two-dimensional mammograms (DBT+SM) versus digital mammography (DM) yielded lower recall rates for women with Volpara Density Grade (VDG) 1 and VDG 2. Adjusted relative risk of recall and screen-detected breast cancer increased with denser breasts for DBT+SM but not for DM. © RSNA, 2020 Online supplemental material is available for this article. See also the editorial by Sechopoulos and Athanasiou in this issue.",2020,"For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8; P < .001; VDG 3: 2.4; P < .001; VDG 4: 1.8; P = .02) and screen-detected breast cancer (VDG 2: 2.4; P = .004; VDG 3: 2.8; P = .01; VDG 4: 2.8; P = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3; P = .06; VDG 3: 1.1; P = .41; VDG 4: 1.1; P = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7; P = .13; VDG 3: 2.1; P = .06; VDG 4: 2.2; P = .15).","['Bergen as part of BreastScreen Norway, 2016-2017', 'women with dense breasts', 'women with Volpara Density Grade (VDG) 1 and VDG 2', '28\u2009749 women, 14\u2009380 of whom were screened with DBT+SM and 14\u2009369 of whom were screened with DM (both groups: median age, 59 years; interquartile range [IQR], 54-64 years']","['DBT+SM and DM', 'Digital Breast Tomosynthesis and Digital Mammography', 'DBT+SM', 'digital breast tomosynthesis combined with synthetic two-dimensional mammograms (DBT+SM) versus digital mammography (DM', ' Digital breast tomosynthesis (DBT', 'digital mammography (DM']","['Adjusted relative risk of recall and screen-detected breast cancer', 'recall rates', 'relative risk of screen-detected breast cancer', 'rates of recall, false-positive (FP) findings, biopsy, cancer detection rate, positive predictive value of recalls and biopsies, and histopathologic tumor characteristics by density using DBT combined with two-dimensional synthetic mammography (SM) (hereafter, DBT+SM) versus DM', 'recall rate']","[{'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C3472347', 'cui_str': 'Digital breast tomosynthesis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0860950', 'cui_str': 'Digital Mammography'}]",28749.0,0.19577,"For DBT+SM, adjusted relative risk of recall (VDG 2: 1.8; P < .001; VDG 3: 2.4; P < .001; VDG 4: 1.8; P = .02) and screen-detected breast cancer (VDG 2: 2.4; P = .004; VDG 3: 2.8; P = .01; VDG 4: 2.8; P = .05) increased with VDG, whereas no differences were observed for DM (relative risk of recall for VDG 2: 1.3; P = .06; VDG 3: 1.1; P = .41; VDG 4: 1.1; P = .71; and relative risk of screen-detected breast cancer for VDG 2: 1.7; P = .13; VDG 3: 2.1; P = .06; VDG 4: 2.2; P = .15).","[{'ForeName': 'Nataliia', 'Initials': 'N', 'LastName': 'Moshina', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Hildegunn S', 'Initials': 'HS', 'LastName': 'Aase', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Anders S', 'Initials': 'AS', 'LastName': 'Danielsen', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Ingfrid S', 'Initials': 'IS', 'LastName': 'Haldorsen', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Christoph I', 'Initials': 'CI', 'LastName': 'Lee', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zackrisson', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}, {'ForeName': 'Solveig', 'Initials': 'S', 'LastName': 'Hofvind', 'Affiliation': 'From the Cancer Registry of Norway, PO Box 5313, Majorstuen, 0304 Oslo, Norway (N.M., A.S.D., S.H.); Department of Radiology, Haukeland University Hospital, Bergen, Norway (H.S.A., I.S.H.); Department of Clinical Medicine, University of Bergen, Bergen, Norway (H.S.A., I.S.H.); Department of Radiology, Seattle Cancer Care Alliance, University of Washington, Seattle, Wash (C.I.L.); Department of Translational Medicine, Diagnostic Radiology, Lund University Cancer Center, Malmö, Sweden (S.Z.); and Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway (S.H.).'}]",Radiology,['10.1148/radiol.2020201150']
1989,32925060,"Neuromodulation for Apathy in Alzheimer's Disease: A Double-Blind, Randomized, Sham-Controlled Pilot Study.","BACKGROUND
Apathy, a profound loss of motivation, initiation, and goal directed cognition, is a common comorbidity of Alzheimer's disease (AD). The presence of apathy is associated with rapid progression of AD, long-term impairment, disability, and higher mortality. Pharmacological treatments of apathy are limited.
OBJECTIVE
The primary objective was to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy in AD.
METHODS
A randomized, double-blind, parallel-arm, sham-controlled pilot study was conducted in subjects with AD and apathy (N = 20). Subjects were randomized to rTMS or sham treatment (5 days/week) for four weeks. Primary outcome, apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI), were assessed at baseline and four weeks. Follow-up visits were conducted at 8 and 12 weeks to test the durability of effects of intervention.
RESULTS
Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16) = -3.69; p = 0.002) at 4 weeks. There was also significantly greater improvement in 3MS (6.9 (1.7 to 12.0); t (15) = 2.85; p = 0.012), IADL (3.4 (1.0 to 5.9); χ21 = 7.72; p = 0.006), CGI-S (1.4 (0.5 to 2.3), t (16) = 3.29; p = 0.005), and CGI-I (-2.56 (-3.5 to -1.6), t (17) = -5.72; p < 0.001) for rTMS compared to the sham at 4 weeks. The effects of rTMS were durable at 12 weeks.
CONCLUSION
rTMS may be safely used in subjects with AD and may improve apathy, function, and some aspects of cognition.",2020,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16) = -3.69; p = 0.002) at 4 weeks.","[""Alzheimer's Disease"", 'subjects with AD and apathy (N\u200a=\u200a20', 'Mean age was 77.3 (±7.2) years, 80% were Caucasians and 10% were females', 'subjects with AD']","['rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['3MS', 'IADL', 'apathy evaluation scale-clinician version (AES-C), and secondary outcome measures, modified-Mini Mental State Examination (3MS), instrumental activities of daily living (IADL), and clinical global impression (CGI', 'CGI-S']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.540663,"After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment (-10.1 (-15.9 to -4.3); t (16) = -3.69; p = 0.002) at 4 weeks.","[{'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Eugenia M', 'Initials': 'EM', 'LastName': 'Boozer', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parkes', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Cassandra R', 'Initials': 'CR', 'LastName': 'Hunter', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Caceda', 'Affiliation': 'Department of Psychiatry, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Kalpana P', 'Initials': 'KP', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System (CAVHS), Little Rock, AR, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200640']
1990,32925516,"Impact of Video Education on Patient Knowledge, Anxiety, and Satisfaction in Selective Laser Trabeculoplasty: A Pilot Study.","PRéCIS:: In patients undergoing selective laser trabeculoplasty, preoperative video education did not improve patient knowledge regarding the procedure, decrease anxiety, or increase satisfaction, as these metrics were already favorable across all patients in this study.
PURPOSE
To assess the effect of an educational video on patient knowledge, anxiety, and satisfaction at a selective laser trabeculoplasty (SLT) procedure visit.
MATERIALS AND METHODS
This is a prospective, randomized trial. Patients at a single academic medical center completed a survey at their procedure visit for SLT; patients were randomized to view an educational video or no video before survey administration. Knowledge was assessed with a 10-item questionnaire. The 6-item State-Trait Anxiety Inventory scale (STAI-6) assessed anxiety (score >40 defined significant anxiety). Perceptions of visit quality were assessed using a Likert scale.
RESULTS
Twenty-two patients were randomized into video (n=11) and control (n=11) groups. No difference in knowledge was observed between groups (83.6% control vs. 82.7% video group, P=0.635). No patient had significant anxiety (STAI-6 range, 20 to 40, average 29) and scores were similar between groups (P=0.385). Overall, patients had positive perceptions of visit quality, and there was no significant difference between groups (P=0.999).
CONCLUSION
Patients undergoing SLT had high levels of knowledge, low levels of anxiety, and high levels of satisfaction. In this clinical setting, an educational video seemed to have no additional benefit on these metrics and thus, may be omitted. Further research may be directed toward optimizing patient education regarding SLT, particularly in settings with poor health literacy, limited resources, or limited access to glaucoma specialists.",2020,"No difference in knowledge was observed between groups (83.6% control vs. 82.7% video group, P=0.635).","['Patients at a single academic medical center completed a survey at their procedure visit for SLT; patients', 'patients undergoing', 'Twenty-two patients were randomized into video (n=11) and control (n=11) groups']","['selective laser trabeculoplasty (SLT) procedure visit', 'educational video', 'Selective Laser Trabeculoplasty', 'Video Education', 'educational video or no video prior to survey administration', 'selective laser trabeculoplasty, preoperative video education']","['knowledge', 'high levels of knowledge, low levels of anxiety, and high levels of satisfaction', '6-item State-Trait Anxiety Inventory scale (STAI-6) assessed anxiety', 'patient knowledge, anxiety, and satisfaction', 'Patient Knowledge, Anxiety, and Satisfaction', 'Perceptions of visit quality', 'positive perceptions of visit quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1271447', 'cui_str': 'Selective laser trabeculoplasty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",22.0,0.0668629,"No difference in knowledge was observed between groups (83.6% control vs. 82.7% video group, P=0.635).","[{'ForeName': 'Cason B', 'Initials': 'CB', 'LastName': 'Robbins', 'Affiliation': 'Duke University School of Medicine.'}, {'ForeName': 'C Ellis', 'Initials': 'CE', 'LastName': 'Wisely', 'Affiliation': 'Duke Eye Center, Duke University.'}, {'ForeName': 'Jullia A', 'Initials': 'JA', 'LastName': 'Rosdahl', 'Affiliation': 'Duke Eye Center, Duke University.'}, {'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Muir', 'Affiliation': 'Duke Eye Center, Duke University.'}, {'ForeName': 'Divakar', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Duke Eye Center, Duke University.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001657']
1991,32926799,Effectiveness of Curcuma longa Extract for the Treatment of Symptoms and Effusion-Synovitis of Knee Osteoarthritis : A Randomized Trial.,"BACKGROUND
Current pharmacologic therapies for patients with osteoarthritis are suboptimal.
OBJECTIVE
To determine the efficacy of Curcuma longa extract (CL) for reducing knee symptoms and effusion-synovitis in patients with symptomatic knee osteoarthritis and knee effusion-synovitis.
DESIGN
Randomized, double-blind, placebo-controlled trial. (Australian New Zealand Clinical Trials Registry: ACTRN12618000080224).
SETTING
Single-center study with patients from southern Tasmania, Australia.
PARTICIPANTS
70 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis.
INTERVENTION
2 capsules of CL ( n = 36) or matched placebo ( n = 34) per day for 12 weeks.
MEASUREMENTS
The 2 primary outcomes were changes in knee pain on a visual analogue scale (VAS) and effusion-synovitis volume on magnetic resonance imaging (MRI). The key secondary outcomes were change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and cartilage composition values. Outcomes were assessed over 12 weeks.
RESULTS
CL improved VAS pain compared with placebo by -9.1 mm (95% CI, -17.8 to -0.4 mm [ P = 0.039]) but did not change effusion-synovitis volume (3.2 mL [CI, -0.3 to 6.8 mL]). CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm]; P = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]). The incidence of adverse events was similar in the CL ( n = 14 [39%]) and placebo ( n = 18 [53%]) groups ( P = 0.16); 2 events in the CL group and 5 in the placebo group may have been treatment related.
LIMITATION
Modest sample size and short duration.
CONCLUSION
CL was more effective than placebo for knee pain but did not affect knee effusion-synovitis or cartilage composition. Multicenter trials with larger sample sizes are needed to assess the clinical significance of these findings.
PRIMARY FUNDING SOURCE
University of Tasmania and Natural Remedies Private Limited.",2020,"CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm]; P = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]).","['70 participants with symptomatic knee osteoarthritis and ultrasonography-defined effusion-synovitis', 'Single-center study with patients from southern Tasmania, Australia', 'patients with osteoarthritis are suboptimal', 'Symptoms and Effusion-Synovitis of Knee Osteoarthritis ', 'patients with symptomatic knee osteoarthritis and knee effusion-synovitis']","['2 capsules of CL', 'Curcuma longa extract (CL', 'placebo', 'Curcuma longa Extract']","['VAS pain', 'change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and cartilage composition values', 'WOMAC knee pain', 'incidence of adverse events', 'knee pain on a visual analogue scale (VAS) and effusion-synovitis volume on magnetic resonance imaging (MRI', 'lateral femoral cartilage T2 relaxation time']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039335', 'cui_str': 'Tasmania'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0409700', 'cui_str': 'Synovitis of knee'}, {'cui': 'C0343166', 'cui_str': 'Knee joint effusion'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0077524', 'cui_str': 'Turmeric extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",70.0,0.595397,"CL also improved WOMAC knee pain (-47.2 mm [CI, -81.2 to -13.2 mm]; P = 0.006) but not lateral femoral cartilage T2 relaxation time (-0.4 ms [CI, -1.1 to 0.3 ms]).","[{'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Jones', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Winzenberg', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Guoqi', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Laslett', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Hopper', 'Affiliation': 'Monash University, Melbourne, Victoria, Australia (I.H.).'}, {'ForeName': 'Ambrish', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Royal Hobart Hospital, Hobart, Tasmania, Australia (R.J.).'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Fripp', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia (J.F.).'}, {'ForeName': 'Changhai', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia, and Southern Medical University, Guangzhou, China (C.D.).'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Antony', 'Affiliation': 'University of Tasmania, Hobart, Tasmania, Australia (Z.W., G.J., T.W., G.C., L.L.L., D.A., A.S., B.A.).'}]",Annals of internal medicine,['10.7326/M20-0990']
1992,32926814,Rifabutin triple therapy increased H pylori eradication vs. amoxicillin + omeprazole in treatment-naive patients.,"SOURCE CITATION
Graham DY, Canaan Y, Maher J, et al. Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. Ann Intern Med. 2020;172:795-802. 32365359.",2020,"Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. ",['treatment-naive patients'],"['Rifabutin triple therapy', 'amoxicillin + omeprazole', 'Rifabutin-based triple therapy (RHB-105']",['H pylori eradication'],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",,0.120731,"Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. ","[{'ForeName': 'Jacob Mathew', 'Initials': 'JM', 'LastName': 'Jr', 'Affiliation': 'Parkview Medical Center, Pueblo, Colorado, USA (J.M.J.).'}]",Annals of internal medicine,['10.7326/ACPJ202009150-033']
1993,32926818,Correction: Long-Term Weight Loss With Metformin or Lifestyle Intervention in the Diabetes Prevention Program Outcomes Study.,,2020,,[],['Metformin or Lifestyle Intervention'],[],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.011246,,[],Annals of internal medicine,['10.7326/L20-0029']
1994,32927099,"A prospective, international, randomized, noninferiority study comparing an titanium implantable vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study).",,2020,,[],['titanium implantable vertebral augmentation device versus balloon kyphoplasty'],[],[],"[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]",[],,0.014045,,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Noriega', 'Affiliation': 'Hospital Clinico-Universitario de Valladolid, Calle Ramon y Cajal S/n, 47008 Valladolid, Spain. Electronic address: noriega1970@icloud.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Marcia', 'Affiliation': 'Direttore U.O.C. Radiologia, Ospedale SS. Trinità ASL8, via Is Mirrionis 92, 09121 Cagliari, Sardinia, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Theumann', 'Affiliation': ""Department of Radiology, Bois-Cerf Clinic, Avenue d'Ouchy 31, 1006 Lausanne, Switzerland.""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Blondel', 'Affiliation': 'Department of Orthopedic, Trauma and Spine surgery, CHU de La Timone, 264 rue Saint Pierre, 13385 Marseille, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': 'Department of Neurosurgery, Locomotor Centre, CHU Brest Cavale Blanche, Bd Tanguy Prigent, 29609 Brest, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hassel', 'Affiliation': 'Chefarzt Wirbelsäulenchirurgie, Loretto-Krankenhaus Freiburg, Mercystr. 6-14, 79100 Freiburg, Germany.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Maestretti', 'Affiliation': 'Department of Orthopedic Surgery, HFR Fribourg, Cantonal Hospital, 1er étage, Case postale 1708, Fribourg, Switzerland.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Petit', 'Affiliation': 'Neurosurgery Unit, Hôpital Jean Minjoz, 3 Boulevard Alexandre Fleming, 25030 Besançon, France.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Weidle', 'Affiliation': 'Krankenhaus NEUWERK, Sankt Augustinus Kliniken, Dünner Strasse 214-216, 41066 Mönchengladbach, Germany.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Gonzalez', 'Affiliation': 'Interventional Neuroradiology, Hospital Universitario Marqués de Valdecilla, Av. Valdecilla, s/n, 39008 Santander, Spain.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Kaya', 'Affiliation': 'APHM, Hopital Nord, Pavillon Mistral, 1er étage, Chemin des Bourrely, 13915 Marseille, France.'}, {'ForeName': 'Adamou', 'Initials': 'A', 'LastName': 'Touta', 'Affiliation': 'APHM, Hopital Nord, Pavillon Mistral, 1er étage, Chemin des Bourrely, 13915 Marseille, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Fuentes', 'Affiliation': 'Neurosurgery Unit, CHU La Timone-Hôpital Adultes-5eme étage, 264 rue Saint Pierre, 13385 Marseille, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pflugmacher', 'Affiliation': 'Klinik und Poliklinik für Orthopädie und Unfallchirurgie, UniversitätsklinikumBonn, Sigmund-Freud-Str. 25, 53127 Bonn, Germany.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.08.021']
1995,32933119,Effects of a Person-Centered Nursing Intervention for Frailty among Prefrail Community-Dwelling Older Adults.,"This study examined the effects of a person-centered nursing intervention program for frailty (PNIF) targeting community-dwelling prefrail older people in South Korea. The study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index. The intervention group ( n = 20) received group intervention sessions two days/week for twelve weeks and the control group ( n = 20) attended lectures about frailty prevention one day/week for four weeks. The evaluation instruments included the CHS Frailty Index, a JAMAR ® hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS). Significant differences were found in the CHS Frailty Index ( p < 0.001), left-hand grip strength ( p = 0.022), right-hand grip strength ( p = 0.009), SPPB ( p = 0.007), K-CHAMPS ( p = 0.009), MNA ( p = 0.018), and GDSSF-K ( p = 0.001) between the two groups after 12 weeks. No significant between-group differences in ESSI scores were observed. The PNIF effectively improved grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty among community-dwelling older adults.",2020,"Significant differences were found in the CHS Frailty Index ( p < 0.001), left-hand grip strength ( p = 0.022), right-hand grip strength ( p = 0.009), SPPB ( p = 0.007), K-CHAMPS ( p = 0.009), MNA ( p = 0.018), and GDSSF-K ( p = 0.001) between the two groups after 12 weeks.","['study participants were 40 community-dwelling older adults (≥65 years) who were classified as prefrail on the Cardiovascular Health Study (CHS) frailty index', 'Prefrail Community-Dwelling Older Adults', 'frailty (PNIF) targeting community-dwelling prefrail older people in South Korea']","['Person-Centered Nursing Intervention', 'control group ( n = 20) attended lectures about frailty prevention', 'person-centered nursing intervention program']","['grip strength, physical function, physical activity, and nutritional status, reduced depression, and prevented frailty', 'SPPB', 'ESSI scores', 'right-hand grip strength', 'K-CHAMPS', 'CHS Frailty Index, a JAMAR ® hydraulic hand dynamometer, the Short Physical Performance Battery (SPPB), the Korean version of the Community Healthy Activities Model Program for Seniors Questionnaire (K-CHAMPS), the Mini Nutritional Assessment (MNA), the Geriatric Depression Scale Short Form-Korea Version (GDSSF-K), the ENRICHD Social Support Instrument (ESSI), and the Goal Attainment Scale (GAS', 'CHS Frailty Index', 'left-hand grip strength']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3850124', 'cui_str': 'Mini Nutrition Assessment'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",40.0,0.0117517,"Significant differences were found in the CHS Frailty Index ( p < 0.001), left-hand grip strength ( p = 0.022), right-hand grip strength ( p = 0.009), SPPB ( p = 0.007), K-CHAMPS ( p = 0.009), MNA ( p = 0.018), and GDSSF-K ( p = 0.001) between the two groups after 12 weeks.","[{'ForeName': 'Jiyeon', 'Initials': 'J', 'LastName': 'Ha', 'Affiliation': 'College of Nursing, Konyang University, Daejeon 35365, Korea.'}, {'ForeName': 'Yeon-Hwan', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Seoul National University, Seoul 03080, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17186660']
1996,32935287,Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers.,"INTRODUCTION
Balovaptan, an investigational vasopressin 1a receptor antagonist that has been evaluated for improvement of social communication and interaction, is primarily metabolized by cytochrome P450 3A4 (CYP3A4).
METHODS
Two single-center, non-randomized, two-period, phase 1 studies assessed the effect of the strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan in healthy volunteers. Participants received balovaptan (5 or 10 mg/day) alone for 10 days, or in combination with itraconazole (200 mg/day) for 15 days, or rifampicin (600 mg/day) for 10 days, following balovaptan washout and itraconazole/rifampicin pre-dosing. Geometric mean ratios (GMRs) and 90% confidence intervals (90% CIs) for the area under the concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ) of balovaptan dosed with vs. without itraconazole/rifampicin were estimated from a mixed effects model.
RESULTS
Both studies comprised 15-16 healthy male and female volunteers. Itraconazole 200 mg/day elevated steady-state exposure to 5 mg/day balovaptan approximately 4.5-5.5-fold (Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ 5 days to ~ 13-14 days. Rifampicin 600 mg/day resulted in ~ 90% reductions in both the C max (Day 10 GMR [90% CI], 0.14 [0.12-0.15]) and AUC (0.07 [0.06-0.07]) of balovaptan 10 mg/day. Time to balovaptan steady state could not be determined with rifampicin. There were no clinically significant safety findings in either study.
CONCLUSIONS
Strong modulators of CYP3A4 activity will significantly alter the PK of balovaptan, with the effect of CYP3A4 induction greater than that of inhibition. Caution should be taken when concomitantly dosing balovaptan with moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors.
TRIAL REGISTRATION NUMBER
NCT03579719; NCT03586726.",2020,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","['Healthy Volunteers', 'healthy volunteers', '15-16 healthy male and female volunteers']","['Rifampicin', 'Itraconazole 200\xa0mg/day elevated steady-state exposure to 5', 'itraconazole/rifampicin', 'balovaptan washout and itraconazole/rifampicin pre-dosing', 'strong CYP3A4 inhibitor itraconazole (study NCT03579719) or the strong CYP3A4 inducer rifampicin (study NCT03586726) at steady state on the pharmacokinetics (PK) of steady-state balovaptan', 'balovaptan (5 or 10\xa0mg/day) alone for 10\xa0days, or in combination with itraconazole', 'rifampicin', 'Itraconazole and Rifampicin']","['Balovaptan Pharmacokinetics', 'Geometric mean ratios (GMRs', 'time to steady state from\u2009', 'concentration-time curve over the dosing interval (AUC) and maximum plasma concentration (C max ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C2917463', 'cui_str': 'Itraconazole 200 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0439565', 'cui_str': 'Pre-dose'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C1142644', 'cui_str': 'cytochrome P450 3A4 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.036334,"(Day 15 GMR [90% CI], 4.46 [4.06-4.90] for C max and 5.57 [5.00-6.21] for AUC) and extended the time to steady state from ~ ","[{'ForeName': 'Michael G M', 'Initials': 'MGM', 'LastName': 'Derks', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK. michael.derks@roche.com.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wandel', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Young', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Stuart K', 'Initials': 'SK', 'LastName': 'Bolt', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Meyenberg', 'Affiliation': 'F. Hoffmann-La Roche AG, Basel, Switzerland.'}]",Advances in therapy,['10.1007/s12325-020-01491-y']
1997,32939747,"Short-Term Steady-State Pattern Electroretinography Changes Using a Multi-Pressure Dial in Ocular Hypertensive, Glaucoma Suspect, and Mild Open-Angle Glaucoma Patients: A Randomized, Controlled, Prospective, Pilot Study.","INTRODUCTION
This study evaluates the effects of the multi-pressure dial (MPD) on steady-state pattern electroretinography (ss-pERG) parameters. The study is a randomized, controlled, prospective, pilot trial in a private practice setting with ocular hypertensive (OHT), glaucoma suspect, and open-angle glaucoma (OAG) subjects.
METHODS
This study included nine patients (64 ± 9.0 years, nine female) with OHT, glaucoma suspect, or mild OAG. One eye of each subject was randomized to receive negative periocular pressure, while the contralateral eye served as the intrasubject control through the goggle without negative pressure. The Diopsys High Contrast Sensitivity ss-pERG protocol was conducted on both eyes of each subject while wearing the MPD device. Application of negative periocular pressure was set at 50% of baseline intraocular pressure for each study eye.
RESULTS
Following 2 h of negative periocular pressure application, the difference in MagnitudeD (MagD) from baseline for eyes randomized to receive negative periocular pressure (+ 0.17 versus - 0.26) was statistically significant (p = 0.023). Over the same period, the change in MagD/Magnitude (MagD/Mag ratio) from baseline for eyes randomized to receive negative periocular pressure was also higher (+ 0.14 versus - 0.16), compared to the control eyes, approached significance (p = 0.059).
CONCLUSIONS
Following 2 h of MPD wear, the measured MagD and MagD/Mag ratio improved compared to control, suggesting that negative periocular pressure application to the anterior globe can lead to short-term improvement in one measure of retinal ganglion cell function.",2020,"Mag ratio) from baseline for eyes randomized to receive negative periocular pressure was also higher (+ 0.14 versus - 0.16), compared to the control eyes, approached significance (p = 0.059).
","['private practice setting with ocular hypertensive (OHT), glaucoma suspect, and open-angle glaucoma (OAG) subjects', 'Ocular Hypertensive, Glaucoma Suspect, and Mild Open-Angle Glaucoma Patients', 'nine patients (64\u2009±\u20099.0\xa0years, nine female) with OHT, glaucoma suspect, or mild OAG']","['multi-pressure dial (MPD', 'Short-Term Steady-State Pattern Electroretinography Changes Using a Multi-Pressure Dial']","['MagD and MagD', 'MagnitudeD (MagD', 'change in MagD/Magnitude (MagD', 'retinal ganglion cell function', 'Mag ratio', 'steady-state pattern electroretinography (ss-pERG) parameters']","[{'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0017614', 'cui_str': 'Glaucoma suspect'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0430848', 'cui_str': 'Steady state pattern electroretinography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0129439', 'cui_str': 'Myelin associate glycoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0430848', 'cui_str': 'Steady state pattern electroretinography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",9.0,0.0310285,"Mag ratio) from baseline for eyes randomized to receive negative periocular pressure was also higher (+ 0.14 versus - 0.16), compared to the control eyes, approached significance (p = 0.059).
","[{'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Kudrna', 'Affiliation': 'Department of Ophthalmology, Penn State College of Medicine, Hershey, PA, USA. jkudrna@pennstatehealth.psu.edu.'}, {'ForeName': 'Tanner J', 'Initials': 'TJ', 'LastName': 'Ferguson', 'Affiliation': 'Cole Eye Institute, Cleveland, OH, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Swan', 'Affiliation': 'Vance Thompson Vision, Bozeman, MT, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Ferguson', 'Affiliation': 'Dunes Eye Consultants, Dakota Dunes, SD, USA.'}, {'ForeName': 'Brandon J', 'Initials': 'BJ', 'LastName': 'Baartman', 'Affiliation': 'Vance Thompson Vision, Omaha, NE, USA.'}, {'ForeName': 'Adam R', 'Initials': 'AR', 'LastName': 'Bleeker', 'Affiliation': 'University of South Dakota Sanford School of Medicine, Sioux Falls, SD, USA.'}, {'ForeName': 'Ramu G', 'Initials': 'RG', 'LastName': 'Sudhagoni', 'Affiliation': 'HemoSonics, LLC, Charlottesville, VA, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Berdahl', 'Affiliation': 'Vance Thompson Vision, Sioux Falls, SD, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Greenwood', 'Affiliation': 'Vance Thompson Vision, West Fargo, ND, USA.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00302-5']
1998,33235902,Cough peak flow to predict the extubation outcome: Comparison between three cough stimulation methods.,"Objectives
The purpose of this study was to compare the predictive value of three cough peak flow (CPF) maneuvers in predicting the extubation outcome in a cohort of mechanically ventilated subjects.
Methods
Eighty-one mechanically ventilated subjects who succeeded in the spontaneous breathing trial were included. In a randomized order, CPF was stimulated and measured using three methods: voluntary command (V_CPF), tracheal saline instillation (S_CPF), and mechanical stimulation with a catheter (C_CPF). Additionally, CPF was measured 20 min after the extubation (PE_CPF). The diagnostic accuracy of the CPF methods in relation to the extubation outcome was measured using the receiver operating characteristic (ROC) curve. ROC curve results were compared using the Hanley and McNeil method.
Results
The three methods presented high accuracy in predicting the extubation outcome (V_CPF = 0.89, S_CPF = 0.93, and C_CPF = 0.90), without statistically significant differences between them (V_CPF vs. S_CPF, p = 0.14; V_CPF vs. C_CPF, p = 0.84; S_CPF vs. C_CPF, p = 0.13). The optimum cutoff values were V_CPF = 45 L/min, S_CPF = 60 L/min, and C_CPF = 55 L/min. PE_CPF also showed high accuracy in predicting the extubation outcome (AUC = 0.95; cutoff = 75 L/min).
Conclusions
In mechanically ventilated and cooperative subjects, there is no difference in the accuracy of CPF measured voluntarily, with stimulation using saline or by catheter stimulation in predicting the reintubation. CPF recording after endotracheal tube removal has high accuracy to predict the extubation outcome.",2020,"The three methods presented high accuracy in predicting the extubation outcome (V_CPF = 0.89, S_CPF = 0.93, and C_CPF = 0.90), without statistically significant differences between them (V_CPF vs. S_CPF, p = 0.14; V_CPF vs. C_CPF, p = 0.84; S_CPF vs. C_CPF, p = 0.13).","['Methods\n\n\nEighty-one mechanically ventilated subjects who succeeded in the spontaneous breathing trial were included', 'a cohort of mechanically ventilated subjects']","['PE_CPF', 'voluntary command (V_CPF), tracheal saline instillation (S_CPF), and mechanical stimulation with a catheter (C_CPF', 'cough peak flow (CPF) maneuvers']",['Cough peak flow'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C2945595', 'cui_str': 'Tracheal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C1285354', 'cui_str': 'Mechanical stimulation'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0857465', 'cui_str': 'Peak flow'}]",81.0,0.056512,"The three methods presented high accuracy in predicting the extubation outcome (V_CPF = 0.89, S_CPF = 0.93, and C_CPF = 0.90), without statistically significant differences between them (V_CPF vs. S_CPF, p = 0.14; V_CPF vs. C_CPF, p = 0.84; S_CPF vs. C_CPF, p = 0.13).","[{'ForeName': 'Christiane Melo', 'Initials': 'CM', 'LastName': 'Almeida', 'Affiliation': 'Rehabilitation Sciences Post-Graduation Program, Augusto Motta University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Agnaldo José', 'Initials': 'AJ', 'LastName': 'Lopes', 'Affiliation': 'Rehabilitation Sciences Post-Graduation Program, Augusto Motta University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Fernando Silva', 'Initials': 'FS', 'LastName': 'Guimarães', 'Affiliation': 'Physical Therapy Department, Medical School, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",Canadian journal of respiratory therapy : CJRT = Revue canadienne de la therapie respiratoire : RCTR,['10.29390/cjrt-2020-037']
1999,32946551,Do home modifications reduce care home admissions for older people? A matched control evaluation of the Care & Repair Cymru service in Wales.,"BACKGROUND
home advice and modification interventions aim to promote independent living for those living in the community, but quantitative evidence of their effectiveness is limited.
AIM
assess the risk of care home admissions for people with different frailty levels receiving home advice and modification interventions against a control group who do not.
STUDY DESIGN AND SETTING
matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice. The intervention group received the Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales.
METHODS
frailty, age and gender were used in propensity score matching to assess the Hazard Ratio (HR) of care home admissions within a 1-, 3- and 5-year period for the intervention group (N = 93,863) compared to a matched control group (N = 93,863). Kaplan-Meier curves were used to investigate time to a care home admission.
RESULTS
the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years [HR (95%CI)] for those classified as fit [1-year: 2.02 (1.73, 2.36), 3-years: 1.87 (1.72, 2.04), 5-years: 1.99 (1.86, 2.13)] and mildly frail [1-year: 1.25 (1.09, 1.42), 3-years: 1.25 (1.17, 1.34), 5-years: 1.30 (1.23, 1.38)], but a reduced risk of care home admission for moderately [1-year: 0.66 (0.58, 0.75), 3-years: 0.75 (0.70, 0.80), 5-years: 0.83 (0.78, 0.88)] and severely frail individuals [1-year: 0.44 (0.37, 0.54), 3-years: 0.54 (0.49, 0.60), 5-years: 0.60(0.55, 0.66)].
CONCLUSIONS
HRs indicated that the C & RC service helped to prevent care home admissions for moderately and severely frail individuals. The HRs generally increased with follow-up duration.",2020,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","['people with different frailty levels receiving home advice and modification interventions against a control group who do not', '5-years', 'matched control evaluation using linked longitudinal data from the Secure Anonymised Information Linkage (SAIL) Databank, comprising people aged 60-95, registered with a SAIL contributing general practice']","['C & RC service', 'Care & Repair Cymru (C & RC) service, a home advice and modification service available to residents in Wales']","['reduced risk of care home admission', 'risk of a care home admission', 'Hazard Ratio (HR) of care home admissions', 'mildly frail', 'HR (95%CI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}]",,0.0910446,"the intervention group had an increased risk of a care home admission at 1-, 3- and 5-years","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hollinghurst', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fry', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Akbari', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Watkins', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Care & Repair Cymru, Cardiff, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hillcoat-Nallétamby', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Ronan A', 'Initials': 'RA', 'LastName': 'Lyons', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clegg', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Rodgers', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}]",Age and ageing,['10.1093/ageing/afaa158']
2000,32958371,Long-term BAROS scores and independent obesity-related co-morbidity predictors of failure after laparoscopic Roux-en-Y gastric bypass.,"BACKGROUND
Long-term (>5 yr) studies assessing outcomes after laparoscopic Roux-en-Y gastric bypass (LRYGB) using the Bariatric Analysis and Reporting Outcome System (BAROS) are limited. Evidence of predictors of failure long-term after LRYGB is also lacking.
OBJECTIVES
To compare BAROS scores at 5 and 10 years post LRYGB and to establish whether individual obesity-related co-morbidities are associated with suboptimal outcomes at these time points.
SETTING
Single bariatric unit.
METHODS
BAROS scores were analyzed in patients who were 5 years (group A) and 10 years (group B) post LRYGB. Obesity-related co-morbidities as predictors of failure of surgery (defined by % excess weight loss [%EWL] <50% or BAROS total score ≤1) were examined. Intergroup comparative analysis of outcomes and logistic regression modeling to determine predictors of weight loss failure were conducted.
RESULTS
A total of 88 patients were 5 years post LRYGB (group A), and 91 patients were 10 years post LRYGB (group B). A total of 52.3% (46/88) in group A and 54.9% (50/91) in group B had failure of weight loss defined by %EWL <50%. There were no significant differences in percentage of total weight loss, %EWL, or BAROS scores between the 2 groups (21.8% versus 22.0%, P = .897; 48.5% versus 47.1%, P = .993; and 3.7 versus 3.3, P = .332, respectively). No individual obesity-related co-morbidity at time of surgery was associated with suboptimal outcomes (%EWL <50% or BAROS total score ≤1) at 5 years or 10 years after LRYGB.
CONCLUSIONS
Long-term outcomes assessed by the BAROS score appear sustainable between 5 and 10 years after LRYGB surgery, and weight loss achieved at 5 years is maintained at 10 years. Preoperative presence of specific obesity-related co-morbidities was not associated with failure of surgery long-term.",2020,"There were no significant differences in percentage of total weight loss, %EWL, or BAROS scores between the 2 groups (21.8% versus 22.0%, P = .897; 48.5% versus 47.1%, P = .993; and 3.7 versus 3.3, P = .332, respectively).","['88 patients were 5 years post LRYGB (group A), and 91 patients were 10 years post LRYGB (group B', 'patients who were 5 years (group A) and 10 years (group B) post LRYGB', 'Single bariatric unit']","['laparoscopic Roux-en-Y gastric bypass (LRYGB', 'laparoscopic Roux-en-Y gastric bypass']","['failure of weight loss', 'weight loss', 'BAROS scores', 'individual obesity-related co-morbidity', 'percentage of total weight loss, %EWL, or BAROS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",88.0,0.0327004,"There were no significant differences in percentage of total weight loss, %EWL, or BAROS scores between the 2 groups (21.8% versus 22.0%, P = .897; 48.5% versus 47.1%, P = .993; and 3.7 versus 3.3, P = .332, respectively).","[{'ForeName': 'Krashna', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom. Electronic address: krashna@doctors.org.uk.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Askari', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}, {'ForeName': 'Ravikrishna', 'Initials': 'R', 'LastName': 'Mamidanna', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}, {'ForeName': 'Vigyan', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}, {'ForeName': 'Tanveer', 'Initials': 'T', 'LastName': 'Adil', 'Affiliation': 'Department of Upper GI and Bariatric Surgery, Luton and Dunstable University Hospital, Luton, United Kingdom.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.07.037']
2001,32958408,High-intensity interval training in patients with left ventricular assist devices: A pilot randomized controlled trial.,"BACKGROUND
Left ventricular assist device (LVAD) implantation is an established treatment for patients with advanced heart failure. To date, studies evaluating the impact of aerobic training in patients with LVADs have focused on moderate-intensity exercise.
METHODS
This pilot randomized controlled trial compared the effects of high-intensity interval training (HIIT) with those of moderate-intensity continuous training (MICT) on peak oxygen consumption (V̇O 2 peak) in patients with LVADs. Secondary outcomes included 6-minute walk test distance, flow-mediated dilation, and anthropometry. Assessments were conducted at baseline and after 12 weeks of supervised training performed 3 times weekly. Participants were randomized to HIIT (4 sets of 4 minutes at 80%-90% V̇O 2 reserve, alternating with 3 minutes at 50%-60% V̇O 2 reserve) or MICT groups (28 minutes continuously at 50%-60% V̇O 2 reserve). Within and between-group differences were analyzed using linear mixed models. Data are expressed as marginal means with 95% confidence intervals or as mean ± SD.
RESULTS
A total of 21 participants were randomized (HIIT: age 57.7 ± 13.1 years; n = 11 and MICT: age 55.6 ± 14.2 years; n = 10) (mean ± SD). No major adverse events occurred in response to training in either group. HIIT significantly improved V̇O 2 peak (15.6 [13.2-17.8] to 18.4 [16.0-20.8] ml/kg/min) (marginal mean [95% CI]) compared with MICT (16.2 [13.8-18.7] to 17.2 [14.6-19.7] ml/kg/min; p < 0.05 between groups). No significant group differences were detected in secondary outcomes.
CONCLUSION
In patients with LVADs, HIIT was well tolerated and increased aerobic capacity more than MICT. These preliminary findings support the prescription of high-intensity exercise in clinically stable patients with LVADs but warrant validation in a larger sample and across a broader range of physiologic and clinical outcomes.
CLINICAL TRIAL REGISTRATION
URL: https://www.anzctr.org.au, unique identifier: ACTRN12616001596493.",2020,HIIT significantly improved V̇O 2 peak (15.6 [13.2-17.8] to 18.4 [16.0-20.8] ml/kg/min) (marginal mean [95% CI]) compared with MICT (16.2 [13.8-18.7] to 17.2 [14.6-19.7] ml/kg/min; p < 0.05 between groups).,"['patients with advanced heart failure', 'A total of 21 participants were randomized (HIIT: age 57.7 ± 13.1 years; n\u202f=\u202f11 and MICT: age 55.6 ± 14.2 years; n\u202f=\u202f10) (mean ± SD', 'patients with left ventricular assist devices', 'patients with LVADs']","['MICT', 'Left ventricular assist device (LVAD) implantation', 'High-intensity interval training', 'aerobic training', 'high-intensity interval training (HIIT) with those of moderate-intensity continuous training (MICT']","['peak oxygen consumption (V̇O 2 peak', '6-minute walk test distance, flow-mediated dilation, and anthropometry', 'adverse events', 'tolerated and increased aerobic capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0085842', 'cui_str': 'Ventricular assist device'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",21.0,0.283557,HIIT significantly improved V̇O 2 peak (15.6 [13.2-17.8] to 18.4 [16.0-20.8] ml/kg/min) (marginal mean [95% CI]) compared with MICT (16.2 [13.8-18.7] to 17.2 [14.6-19.7] ml/kg/min; p < 0.05 between groups).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Lam', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Spence', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hayward', 'Affiliation': ""Heart Failure and Transplant Unit, Victor Chang Cardiac Research Institute, St Vincent's Hospital, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kaye', 'Affiliation': 'Heart Failure Research Group, Baker Heart and Diabetes Institute, Melbourne, Australia; Department of Cardiology, The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Leet', 'Affiliation': 'Department of Cardiology, The Alfred Hospital, Melbourne, Australia.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Fuller', 'Affiliation': 'Department of Cardiology, The Alfred Hospital, Melbourne, Australia; School of Health Sciences, Swinburne University, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Jacques', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia; Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Australia; Allied Health Department, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia; Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Perth, Australia; Allied Health Department, Fiona Stanley Hospital, Perth, Australia. Electronic address: Andrew.Maiorana@health.wa.gov.au.'}]",The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation,['10.1016/j.healun.2020.08.005']
2002,32961360,COVID-19 hits a trial: Arguments against hastily deviating from the plan.,"The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participants it is now important to consider, how the impact of the pandemic on trial outcome can be assessed, which measures are needed to decide, how to proceed with the trial and what is needed to compensate to irregularity introduced by the pandemic situation. Obviously not all trials will suffer to the same degree: some trials may be close to finalizing recruitment, others may not yet have started. Similarly not all clinical trials investigate vulnerable patient populations, but some will and may in addition have recruited to an extent that beneficial effects achieved in the initial phase of the trial may be outweighed by an increase e.g. in mortality that impacts both treatment groups. The situation is further complicated by the fact that the pandemic reached different countries in the world and even cities in one country at different points in time with different severity. Our example is a randomized and double-blind clinical trial comparing digitoxin and placebo in patients with advanced chronic heart failure. This trial has recruited roughly 1/3 of the overall 2200 patients when the disease outbreak reached Germany. We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post- COVID-19 periods of trial conduct regarding the question, whether the treatment effect can be considered consistent and with this generalizable. This is dependent on the size of the treatment effect and the impact of the pandemic. We argue, that in case of doubt, it may be wise to proceed with the original study plan.",2020,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","['patients with advanced chronic heart failure', '2400 patients when the disease outbreak reached Germany']",['digitoxin and placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0012258', 'cui_str': 'Digitoxin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],2400.0,0.116561,"We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post-","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Großhennig', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: grosshennig.anika@mh-hannover.de.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Institut für Biometrie, Medizinische Hochschule Hannover, Germany. Electronic address: koch.armin@mh-hannover.de.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106155']
2003,32961410,Intranasal oxytocin and the stress-buffering effects of social support during experimentally induced pain: The role of attachment security.,"BACKGROUND
This study examined whether intranasal oxytocin enhances the stress-buffering effects of social support during experimentally induced pain, taking into account the role of individual differences in attachment security.
METHODS
Female participants (N = 193) were randomly assigned to oxytocin (24 IU intranasal) or placebo and to receive support or no support from a friend (2 × 2 factorial design with repeated measures)). Participants underwent the Cold Pressor Task (CPT) and were monitored for heart rate variability (HRV: RMSSD) and heart rate and reported pain levels. The Experiences in Close Relationships Questionnaire was used to measure attachment.
RESULTS
Oxytocin reduced RMSSD (p = 0.003, partial ɳ 2 = 0.03) and increased heart rate (p = 0.039, partial ɳ 2 = 0.03) in individuals who received support, possibly reflecting an enhanced attentional state. Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2 = 0.06).
LIMITATIONS
Only female participants were examined. Future studies are needed to determine sex differences in how oxytocin shapes stress-buffering effects of support.
CONCLUSIONS
Oxytocin may enhance the salience of social proximity and may be a mechanism underlying previously reported social influences on cardiovascular and mental health. However, oxytocin effects depend on interpersonal insecurities and may trigger discomfort in avoidantly attached individuals. Caution about oxytocin's therapeutic promise is warranted.",2021,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2 = 0.06).
","['Only female participants', 'Female participants (N\xa0=\xa0193']","['intranasal oxytocin', 'oxytocin', 'placebo and to receive support or no support from a friend', 'Oxytocin', 'Cold Pressor Task (CPT', 'Intranasal oxytocin']","['heart rate variability (HRV: RMSSD) and heart rate and reported pain levels', 'pain intensity', 'RMSSD', 'heart rate', 'pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0006938', 'cui_str': 'Captopril'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",193.0,0.159338,"Oxytocin did not enhance beneficial effects of social support on perceived pain, but increased pain intensity in avoidantly attached individuals who were supported by a friend (p = 0.009, partial ɳ 2 = 0.06).
","[{'ForeName': 'M M E', 'Initials': 'MME', 'LastName': 'Riem', 'Affiliation': 'Behavioural Science Institute, Radboud University, The Netherlands; Department of Clinical Child and Family Studies, VU University, Amsterdam, The Netherlands. Electronic address: m.riem@psych.ru.nl.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Kunst', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands; Mentaal Beter, Breda, The Netherlands. Electronic address: L.E.Kunst@tilburguniversity.edu.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Kop', 'Affiliation': 'Center of Research on Psychological and Somatic disorders, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands. Electronic address: W.J.Kop@tilburguniversity.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.057']
2004,32933124,Are Respiratory Responses to Cold Air Exercise Different in Females Compared to Males? Implications for Exercise in Cold Air Environments.,"Research has shown that cold air exercise causes significant respiratory dysfunction, especially in female athletes. However, how female and male athletes respond to cold air exercise is not known. Thus, we aimed to compare acute respiratory responses (function, recovery and symptoms) in males and females after high-intensity cold air exercise. Eighteen (nine female) athletes completed two environmental chamber running trials at 0 °C and -20 °C (humidity 34 ± 5%) on different days in a randomized starting order. Spirometry was performed pre, 3, 6, 10, 15 and 20 min post. Respiratory symptoms were measured posttrial and heart rate and rating of perceived exertion were assessed during each trial. No significant differences in delta change (pre to post) were found at either temperature between sexes for FEV 1 , FVC, FEF50% and FEF25-75%. At -20 °C, FEV 1 decreased similarly in both sexes (males: 7.5%, females: 6.3%) but not at 0 °C, p = 0.003. Postexertion respiratory function recovery and reported symptoms were not different between sexes at either temperature. These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise. However, intense exercise at -20 °C is challenging to the respiratory system in both sexes and may lead to altered respiratory responses compared to mild winter conditions like 0 °C.",2020,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","['Eighteen (nine female) athletes completed two environmental chamber running trials at 0', 'males and females after high-intensity cold air exercise', 'female and male athletes', 'female athletes']",['cold air exercise'],"['acute respiratory responses (function, recovery and symptoms) to cold air exercise', 'delta change', 'acute respiratory responses (function, recovery and symptoms', 'posttrial and heart rate and rating of perceived exertion']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004179', 'cui_str': 'Atmosphere Exposure Chambers'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0450029', 'cui_str': 'Cold air'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.0448314,"These results indicate no sex-based differences in acute respiratory responses (function, recovery and symptoms) to cold air exercise.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kennedy', 'Affiliation': 'Faculty of Kinesiology, Sport and Recreation, University of Alberta, Edmonton, AB T6G 2H9, Canada.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lenz', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Faulhaber', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}]",International journal of environmental research and public health,['10.3390/ijerph17186662']
2005,32943015,Can cardiovascular risk management be improved by shared care with general practice to prevent cognitive decline following stroke/TIA? A feasibility randomised controlled trial (SERVED memory).,"BACKGROUND
Cognitive impairment and dementia following cerebrovascular disease are increasingly common in the UK. One potential strategy to prevent post-stroke cognitive decline is multimodal vascular risk factor management. However, its efficacy remains uncertain and its application in vulnerable patients with incident cerebrovascular disease and early cognitive impairment has not been assessed. The primary aim of this study was to assess the feasibility of recruitment and retention of patients with early cognitive impairment post-stroke or transient ischaemic attack (TIA) to a trial of enhanced vascular risk factor management combining primary and secondary care.
METHODS
In this single centre, open label trial adults with a recent stroke or TIA and mild cognitive impairment (MCI) were randomised 1:1 to a three-monthly multimodal vascular risk factor intervention jointly delivered by the trial team and General Practitioner (GP), or control (defined as usual care from the GP). Chosen risk factors were blood pressure (BP), total cholesterol, blood glucose (HbA1C) in those with diabetes, and heart rate and adequacy of anticoagulation in those with atrial fibrillation (AF). Similar patients with normal cognition were enrolled in an embedded observational cohort and also received usual care from the GP. Repeat cognitive screening was undertaken in all participants after 12 months.
RESULTS
Seventy three participants were recruited to the randomised trial and 94 to the observational cohort (21.8% of those screened). From the randomised trial 35/73 (47.9%) dropped out before final follow-up. In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up. The observational cohort demonstrated greater decline in cognitive test scores at 12 months, with no difference between the randomised groups.
CONCLUSIONS
Recruitment to such a study was feasible, but retention of participants was difficult and generally poor rates of risk factor control suggested insufficient application of the intervention. Consequently, successful scaling up of the trial would require protocol changes with less reliance on primary care services. Any future trial should include participants with normal cognition post-stroke as they may be at greatest risk of cognitive decline.
TRIAL REGISTRATION
ISRCTN, ISRCTN42688361 . Registered 16 April 2015.",2020,In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up.,"['Seventy', 'vulnerable patients with incident cerebrovascular disease and early cognitive impairment', 'three participants were recruited to the randomised trial and 94 to the observational cohort (21.8% of those screened', 'patients with early cognitive impairment post-stroke or transient ischaemic attack (TIA', 'Similar patients with normal cognition', 'open label trial adults with a recent stroke or TIA and mild cognitive impairment (MCI', 'participants with normal cognition post-stroke']","['multimodal vascular risk factor intervention jointly delivered by the trial team and General Practitioner (GP), or control (defined as usual care from the GP', 'usual care from the GP']","['heart rate and adequacy of anticoagulation', 'cognitive test scores', 'rates of risk factor control', 'Repeat cognitive screening', 'blood pressure (BP), total cholesterol, blood glucose (HbA1C']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C2712133', 'cui_str': 'Normal cognition'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",73.0,0.232762,In all groups guideline based rates of risk factor control were mostly poor at baseline and did not significantly improve during follow-up.,"[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Bob Champion Research Building, James Watson Road, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Ageing Clinical & Experimental Research Team (ACER), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Yoon K', 'Initials': 'YK', 'LastName': 'Loke', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Garth', 'Initials': 'G', 'LastName': 'Ravenhill', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Fox', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Bob Champion Research Building, James Watson Road, Norwich, UK. john.potter@uea.ac.uk.'}]",BMC geriatrics,['10.1186/s12877-020-01760-z']
2006,32948472,Improvements in Antibiotic Appropriateness for Cystitis in Older Nursing Home Residents: A Quality Improvement Study With Randomized Assignment.,"OBJECTIVE
To determine the impact of an educational quality improvement initiative on the appropriateness of antibiotic prescribing restricted to uncomplicated cystitis in older noncatheterized nursing home residents.
DESIGN
Quality improvement study with randomized assignment.
SETTINGS AND PARTICIPANTS
Twenty-five nursing homes in United States were randomized to the intervention or usual care group by strata that included state, urban/rural status, bed size, and geographic separation.
METHODS
A 12-month trial of a low-intensity multifaceted antimicrobial stewardship intervention focused on uncomplicated cystitis in nursing home residents vs usual care. The outcome was the modified Medication Appropriateness Index as assessed by a blinded geriatric clinical pharmacist and consisted of an assessment of antibiotic effectiveness, dosage, drug-drug interactions, and duration.
RESULTS
There were 75 cases (0.15/1000 resident days) in intervention and 92 (0.22/1000 resident days) in control groups with a probable cystitis per consensus guidelines. Compared with controls, there was a statistically nonsignificant 21% reduction in the risk of inappropriate antibiotic prescribing (nonzero Medication Appropriateness Index score rate 0.13 vs 0.21/1000 person days; adjusted incident rate ratio 0.79; 95% confidence interval 0.45‒1.38). There was a favorable comparison in inappropriateness of duration (77% vs 89% for intervention vs control groups, respectively; P = .0394). However, the intervention group had more problems with drug-drug interactions than the control group (8% vs 1%, respectively; P = .0463). Similarly, the intervention group had a nonsignificant trend toward more problems with dosage (primarily because of the lack of adjustment for decreased renal function) than the control group (32% vs 25%, respectively; P = .3170). Both groups had similar rates of problems with choice/effectiveness (44% vs 45%; P = .9417). The most common class of antibiotics prescribed inappropriately was quinolones (25% vs 23% for intervention versus control groups, respectively; P = .7057).
CONCLUSIONS AND IMPLICATIONS
A low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis. Efforts to improve antibiotic prescribing in addition to the low-intensity intervention might include a consultant pharmacist in a nursing home to identify inappropriate prescribing practices.",2020,A low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis.,"['Older Nursing Home Residents', 'nursing home residents vs usual care', 'older noncatheterized nursing home residents', 'Twenty-five nursing homes in United States', 'nursing home residents with likely uncomplicated cystitis']","['intervention or usual care group by strata that included state, urban/rural status, bed size, and geographic separation', 'low-intensity multifaceted antimicrobial stewardship intervention']","['risk of inappropriate antibiotic prescribing (nonzero Medication Appropriateness Index score rate', 'renal function', 'rates of problems with choice/effectiveness', 'antibiotic effectiveness, dosage, drug-drug interactions, and duration', 'modified Medication Appropriateness Index', 'problems with drug-drug interactions', 'appropriate antibiotic prescribing', 'inappropriateness of duration']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600244', 'cui_str': 'Bed Sizes'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0778407,A low-intensity intervention showed a trend toward improved appropriate antibiotic prescribing in nursing home residents with likely uncomplicated cystitis.,"[{'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Hanlon', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, PA; Geriatic Research Education and Clinical Center/Center for Health Equity Research and Promotion, VA Pittsburgh Health System, Pittsburgh, PA. Electronic address: jth14@pitt.edu.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, PA; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Schweon', 'Affiliation': 'Infection Prevention Consultant, Saylorsburg, PA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drinka', 'Affiliation': 'Division of Internal Medicine and Geriatrics, University of Wisconsin, Madison, WI.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Crnich', 'Affiliation': 'Division of Infectious Diseases, University of Wisconsin School of Medicine and Public Health, Madison, WI; William S. Middleton VA Hospital, Madison, WI.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nace', 'Affiliation': 'Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, PA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.07.040']
2007,32947299,Comparison of the Safety and Efficacy of Foam Sclerotherapy With 1: 2 Polidocanol to Air Ratio Versus 1: 4 Ratio for the Treatment of Reticular Veins of the Lower Extremities.,"BACKGROUND
Foam sclerotherapy is a common treatment of lower extremity reticular veins. The effect of different liquid-gas ratios on foam stability and efficacy has been controversial.
OBJECTIVE
To evaluate the use of 2 different polidocanol (POL) to air ratios for the treatment of reticular veins of the lower extremities.
METHODS AND MATERIALS
Patients with lower extremity reticular veins were randomized to foam sclerotherapy with POL mixed with 4 mL of room air for one lower extremity or 2 mL for the other lower extremity. All telangiectasias were treated with glycerin immediately after treatment of the reticular veins. Adverse events (AEs) and efficacy were evaluated by both subject and blinded investigator.
RESULTS
Thirty subjects completed the study. No statistically significant difference was seen in AEs between the 2 different POL to air ratios by subject questionnaire and blinded investigator scores at all time points. Subjects and blinded investigator reported a mean improvement between 0% and 50% at Day 21 and 26% to 75% at Day 90, which was not significantly different between groups.
CONCLUSION
Two different POL to air ratios, 1:2 versus 1:4, were similarly safe and efficacious for the treatment reticular veins of the lower extremities.",2020,No statistically significant difference was seen in AEs between the 2 different POL to air ratios by subject questionnaire and blinded investigator scores at all time points.,"['Thirty subjects completed the study', 'reticular veins of the lower extremities', 'Reticular Veins of the Lower Extremities', 'Patients with lower extremity reticular veins']","['foam sclerotherapy with POL mixed with 4 mL of room air for one lower extremity or 2 mL for the other lower extremity', 'polidocanol (POL', 'Polidocanol', 'glycerin', 'Foam Sclerotherapy']","['Safety and Efficacy', 'POL to air ratios by subject questionnaire and blinded investigator scores', 'Adverse events (AEs) and efficacy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439739', 'cui_str': 'Reticular'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0036435', 'cui_str': 'Injection of sclerosing agent'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0071330', 'cui_str': 'polidocanol'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0556732,No statistically significant difference was seen in AEs between the 2 different POL to air ratios by subject questionnaire and blinded investigator scores at all time points.,"[{'ForeName': 'Elika', 'Initials': 'E', 'LastName': 'Hoss', 'Affiliation': 'Department of Dermatology, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Ramya', 'Initials': 'R', 'LastName': 'Kollipara', 'Affiliation': 'Westlake Dermatology & Cosmetic Surgery, Dallas, Texas.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Boen', 'Affiliation': 'Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, California.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Alhaddad', 'Affiliation': 'Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, California.'}, {'ForeName': 'Mitchel P', 'Initials': 'MP', 'LastName': 'Goldman', 'Affiliation': 'Cosmetic Laser Dermatology, A West Dermatology Company, San Diego, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002709']
2008,32947595,Cost-Effectiveness of Volar Locking Plate Compared with Augmented External Fixation for Displaced Intra-Articular Wrist Fractures.,"BACKGROUND
The purpose of the present study was to estimate the cost-effectiveness of treating displaced, intra-articular distal radial fractures with volar locking plate fixation compared with augmented external fixation.
METHODS
A cost-utility analysis was conducted alongside a randomized, clinical trial comparing 2 surgical interventions for intra-articular distal radial fractures. One hundred and sixty-six patients were allocated to either volar locking plate fixation (84 patients) or external fixation (82 patients) and were followed for 2 years. Health-related quality of life was assessed with the EuroQol-5 Dimensions and was used to calculate patients' quality-adjusted life-years (QALYs). Resource use was identified prospectively at the patient level at all follow-up intervals. Costs were estimated with use of both a health-care perspective and a societal perspective. Results were expressed in incremental cost-effectiveness ratios, and uncertainty was assessed with use of bootstrapping methods.
RESULTS
The average QALY value was equivalent between the groups (1.70463 for the volar locking plate group and 1.70726 for the external fixation group, yielding a nonsignificant difference of -0.00263 QALY). Health-care costs were equal between the groups, with a nonsignificant difference of &OV0556;52 (p = 0.8) in favor of external fixation. However, the external fixation group had a higher loss of productivity due to absence from work (5.5 weeks in the volar locking plate group compared with 9.2 weeks for the external fixation group; p = 0.02). Consequently, the societal costs were higher for the external fixation group compared with the volar locking plate group (&OV0556;18,037 compared with &OV0556;12,567, representing a difference of &OV0556;5,470; p = 0.04) in favor of the volar locking plate group. Uncertainty analyses showed that there is indifference regarding which method to recommend from a health-care perspective, with volar locking plate treatment and external fixation having a 47% and 53% likelihood of being cost-effective, respectively. From the societal perspective, volar locking plate treatment had a 90% likelihood of being cost-effective.
CONCLUSIONS
External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work.
LEVEL OF EVIDENCE
Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"CONCLUSIONS
External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work.
","['Displaced Intra-Articular Wrist Fractures', 'intra-articular distal radial fractures', 'One hundred and sixty-six patients']","['External fixation', 'volar locking plate fixation (84 patients) or external fixation', 'volar locking plate', 'volar locking plate fixation compared with augmented external fixation', 'Volar Locking Plate Compared with Augmented External Fixation', 'volar locking plate treatment']","['cost-effectiveness', 'Cost-Effectiveness', 'Health-care costs', 'societal costs', 'Health-related quality of life', 'cost-effective', 'incremental cost-effectiveness ratios, and uncertainty', 'average QALY value']","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0435630', 'cui_str': 'Fracture of distal end of radius and ulna'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}, {'cui': 'C0443349', 'cui_str': 'Volar'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",166.0,0.0457825,"CONCLUSIONS
External fixation was less cost-effective than volar locking plate treatment for distal radial fractures from a societal perspective, primarily because patients managed with external fixation had a longer absence from work.
","[{'ForeName': 'Ola-Lars', 'Initials': 'OL', 'LastName': 'Hammer', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Rune Bruhn', 'Initials': 'RB', 'LastName': 'Jakobsen', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Stale', 'Initials': 'S', 'LastName': 'Clementsen', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Fuglesang', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}, {'ForeName': 'Gudrun Waaler', 'Initials': 'GW', 'LastName': 'Bjornelv', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Per-Henrik', 'Initials': 'PH', 'LastName': 'Randsborg', 'Affiliation': 'Akershus University Hospital, Akershus, Norway.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01288']
2009,32949505,Effect of permanent right internal mammary artery occlusion on right coronary artery supply: A randomized placebo-controlled clinical trial.,"Natural, nonsurgical internal mammary artery (IMA) bypasses to the coronary circulation have been shown to function as extracardiac sources of myocardial blood supply. The goal of this randomized, placebo-controlled, double-blind trial was to test the efficacy of permanent right IMA (RIMA) device occlusion on right coronary artery (RCA) occlusive blood supply and on clinical and electrocardiographic (ECG) signs of myocardial ischemia.
METHODS
This was a prospective superiority trial in 100 patients with chronic coronary artery disease randomly allocated (1:1) to RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo group). The primary study end point was RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion at baseline before and at follow-up examination 6 weeks after the trial intervention. CFI is the ratio between simultaneous mean coronary occlusive divided by mean aortic pressure both subtracted by central venous pressure. Simultaneously obtained secondary study end points were the registration of angina pectoris and quantitative intracoronary ECG ST-segment shift.
RESULTS
CFI change during the follow-up period was +0.036 ± 0.068 in the verum group and -0.021 ± 0.097 in the placebo group (P = .0011). Angina pectoris during the same RCA balloon occlusions had disappeared at follow-up in 14/49 patients of the verum group and in 4/49 patients of the placebo group (P = .0091). Simultaneous intracoronary ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group and more severe ischemia in the placebo group.
CONCLUSIONS
Permanent RIMA device occlusion augments RCA supply to the effect of diminishing clinical and electrocardiographic signs of myocardial ischemia during a brief controlled coronary occlusion.",2020,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
",['100 patients with chronic coronary artery disease (CAD) randomly allocated (1:1) to'],"['permanent right internal mammary artery occlusion', 'permanent right IMA (RIMA) device occlusion', 'placebo', 'RIMA vascular device occlusion (verum group) or to RIMA sham procedure (placebo', 'CFI']","['right coronary artery supply', 'registration of angina pectoris and quantitative intracoronary (i.c', 'myocardial ischemia', 'Angina pectoris', 'RCA collateral flow index (CFI) as obtained during a 1-minute ostial RCA balloon occlusion', 'CFI change', 'severe ischemia']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0500531', 'cui_str': 'Right internal mammary artery'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1608397', 'cui_str': 'Device occlusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4552248', 'cui_str': 'Vascular device occlusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1275670', 'cui_str': 'Collateral branch of vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",100.0,0.210404,"ECG ST-segment shift change revealed diminished myocardial ischemia at follow-up in the verum group, and more severe ischemia in the placebo group.
","[{'ForeName': 'Marius R', 'Initials': 'MR', 'LastName': 'Bigler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stoller', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tschannen', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Grossenbacher', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seiler', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, 3010 Bern, Switzerland. Electronic address: christian.seiler@insel.ch.'}]",American heart journal,['10.1016/j.ahj.2020.09.006']
2010,32954487,Responder Profile to Pharmaceutical-Grade Chondroitin Sulfate: An Analysis of the CONCEPT Trial.,"INTRODUCTION
The recent CONCEPT study showed that 800 mg/day of pharmaceutical-grade chondroitin sulfate (CS) was superior to placebo and similar to celecoxib in reducing pain and improving function over 6 months in patients with symptomatic knee osteoarthritis (OA). We investigate, in the present study, whether a responder profile to CS could be defined (i.e., to determine a patient's profile with the best response to treatment).
METHODS
Subjects from the CS group of the CONCEPT study were included in the present analysis. Within the CS group, various subgroups were created on the basis of different categories of age, sex, body mass index, Kellgren and Lawrence grade, age since the beginning of OA, and baseline level of pain (i.e., VAS) or function (i.e., Lequesne index). The nonparametric Kruskal-Wallis (KW) test was applied to compare the VAS pain/Lequesne index evolutions between the subgroups, and the Dwass, Steel, Critchlow, Fligner (DSCF) procedure was used to compute multiple comparisons. The impact of various covariates on the VAS pain/Lequesne index evolution was assessed by means of multiple regression.
RESULTS
Across all analyses, the probability of response to CS treatment was significantly associated with the duration between the date of diagnosis and the initiation of treatment. In other words, the shorter the interval between the diagnosis and the beginning of the treatment, the higher the response for both pain and function, particularly for patients with a duration of less than 5 years compared to patients with a duration of 10 years or more. No other criteria were found to be consistently associated with the response to CS treatment.
CONCLUSION
The treatment of OA with CS has the highest chance of success if administered in the early stage of the disease. Further research with other clinical outcomes should be carried out prior to widespread application of these findings.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03200288.",2020,"No other criteria were found to be consistently associated with the response to CS treatment.
","['Subjects from the CS group of the CONCEPT study were included in the present analysis', 'patients with symptomatic knee osteoarthritis (OA']","['OA with CS', 'pharmaceutical-grade chondroitin sulfate (CS', 'placebo', 'celecoxib']","['probability of response to CS treatment', 'Lequesne index evolution', 'pain and improving function', 'VAS pain']","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0274737,"No other criteria were found to be consistently associated with the response to CS treatment.
","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium. olivier.bruyere@uliege.be.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Dardenne', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Donneau', 'Affiliation': 'Department of Biostatistics, University of Liège, Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'Division of Public Health, Epidemiology and Health Economics, WHO Collaborating Centre for Public Health Aspects of Musculoskeletal Health and Ageing, University of Liège, Liège, Belgium.'}]",Advances in therapy,['10.1007/s12325-020-01484-x']
2011,32940131,The Effect of One Session Split-Belt Treadmill Training on Gait Adaptation in People With Parkinson's Disease and Freezing of Gait.,"BACKGROUND
Freezing of gait (FOG) in Parkinson's disease (PD) is associated with gait asymmetry and switching difficulty. A split-belt treadmill may potentially address those deficits.
OBJECTIVE
To investigate the immediate and retention effects of one-session split-belt treadmill training (SBT) in contrast to regular tied-belt treadmill training (TBT) on gait asymmetry and adaptation in people with PD and FOG (PD + FOG) and healthy controls (HC). Additionally, to investigate differential effects of 3 SBT protocols and compare different gait adaptation outcomes.
METHODS
PD + FOG (n = 45) and HC (n = 36) were randomized to 1 of 3 SBT groups (belt speeds' ratio 0.75:1; 0.5:1 or changing ratios) or TBT group. Participants were tested at Pre, Post, and Retention after one treadmill training session. Gait asymmetry was measured during a standardized adaptation test on the split-belt treadmill.
RESULTS
SBT proved beneficial for gait adaptation in PD + FOG and HC ( P < .0001); however, HC improved more. SBT with changing ratios demonstrated significant effects on gait adaptation from Pre to Post in PD + FOG, supported by strong effect sizes ( d = 1.14) and improvements being retained for 24 hours. Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P = .035) and differentiated best between the groups.
CONCLUSIONS
PD + FOG improved gait adaptation after a single SBT session although effects were smaller than in HC. SBT with changing ratios was the most effective to ameliorate gait adaptation in PD + FOG. These promising results warrant future study on whether long-term SBT strengthens adaptation in PD + FOG and has potential to induce a better resilience to FOG. Clinical trial ID: NCT03725215.",2020,"Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P = .035) and differentiated best between the groups.
","[""Parkinson's disease (PD"", 'people with PD and FOG (PD + FOG) and healthy controls (HC', ""People With Parkinson's Disease and Freezing of Gait"", 'PD + FOG (n = 45) and HC (n = 36']","['PD + FOG', 'regular tied-belt treadmill training (TBT', 'TBT', 'session split-belt treadmill training (SBT', 'One Session Split-Belt Treadmill Training']","['Gait Adaptation', 'Mean step length asymmetry during initial exposure', 'Gait asymmetry', 'gait adaptation', 'gait adaptation in PD + FOG and HC']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",36.0,0.0330414,"Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( P = .035) and differentiated best between the groups.
","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Seuthe', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': ""D'Cruz"", 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Ginis', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Jos Steffen', 'Initials': 'JS', 'LastName': 'Becktepe', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Burkhard', 'Initials': 'B', 'LastName': 'Weisser', 'Affiliation': 'Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schlenstedt', 'Affiliation': 'University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320953144']
2012,32949954,A randomized control trial of meditation compared to music listening to improve cognitive function for breast cancer survivors: Feasibility and acceptability.,"BACKGROUND
and Purpose: Many breast cancer survivors (BCS) experience persistent cognitive and psychological changes associated with their cancer and/or treatment and that have limited treatment options. Therefore, the purpose of this study was to explore the feasibility and effects of a Kirtan Kriya meditation (KK) intervention on cognitive and psychological symptoms compared to an attention control condition, classical music listening (ML), in BCS.
MATERIALS AND METHODS
A randomized control trial design was used. Participants completed eight-week interventions. Cognitive function and psychological symptoms were measured at baseline and post-intervention. Mixed analysis of variance models were examined for all cognitive and psychological outcomes.
RESULTS
27 BCS completed the study. Intervention adherence was 88%. Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's < 0.01). There were no significant group by time effects for cognitive and psychological outcomes, except stress. The ML group reported lower stress at time 2 (p < 0.05).
CONCLUSION
KK and ML are feasible, acceptable, and cost-effective interventions that may be beneficial for survivors' cognition and psychological symptoms. Both interventions were easy to learn, low cost, and required just 12 min/day. Meditation or music listening could offer providers evidence-based suggestions to BCS experiencing cognitive symptoms.
CLINICAL TRIALS REGISTRATION NUMBER
NCT03696056.",2020,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ",['breast cancer survivors'],"['Meditation or music listening', 'music listening', 'classical music listening (ML', 'Kirtan Kriya meditation (KK) intervention', 'meditation']","['cognitive and psychological symptoms', 'time effects for cognitive and psychological outcomes, except stress', ""perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's"", 'cognitive function', 'Cognitive function and psychological symptoms', 'Intervention adherence']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0681251', 'cui_str': 'Classical Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.062006,"Both groups improved in perceived cognitive impairments, cognition related quality of life, verbal memory, and verbal fluency (p's ","[{'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Henneghan', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Oncology, 1601 Trinity St, Austin, TX, 78712, USA. Electronic address: ahenneghan@utexas.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Harrison', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Inselmann', 'Affiliation': 'Cancer Rehab and Integrative Medicine, 4130 Spicewood Springs Rd. Ste. 100, Austin, TX, 78759, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Fico', 'Affiliation': 'The University of Texas at Austin, Kinesiology and Health Education, 2109 San Jacinto Blvd, Austin, TX, 78712, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Schafer', 'Affiliation': 'The University of Texas at Austin, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Division of Clinical Cancer Genomics City of Hope, 1500 E. Duarte Road, Duarte, CA, 91010, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Patt', 'Affiliation': 'Texas Oncology, The University of Texas at Austin, Department of Oncology, Dell Medical School, 1501 Red River Street St, Austin, TX, 78712, USA.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Kesler', 'Affiliation': 'The University of Texas at Austin, School of Nursing, 1710 Red River St, Austin, TX, 78712, USA; The University of Texas at Austin, Department of Diagnostic Medicine, 1601 Trinity St, Austin, TX, 78712, USA.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101228']
2013,32949957,The long-term outcomes of tobacco control strategies based on the cognitive intervention for smoking cessation in COPD patients.,"OBJECTIVE
To evaluate the long-term efficacy of tobacco control strategies based on cognitive intervention for smoking cessation in chronic obstructive pulmonary disease (COPD) patients, and to provide basis for clinical practice.
MATERIALS AND METHODS
102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study. These smokers were randomly divided into intervention group and control group. The intervention group received a cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc. The prevalence of quitting smoking, acute exacerbation (AE), lung function and survival were compared in the groups in 10 years.
RESULTS
There were significant differences between the intervention group and the control group in the rate of persistent quitting smoking in half a year (17.6% vs 3.9%) (P < 0.05), the rate of quitting smoking at the 6th month (58.8% vs 33.3%) (P < 0.05). After 3 months (P < 0.01) and 6 months (P < 0.01), the difference in body weight between the intervention group and the control group was statistically significant. Intervention-group patients had fewer AE per year (P < 0.01) and higher FEV1/FVC ratio (P < 0.01) after 5-year and 10-year follow-up. Besides, the FEV1% predicted in the intervention patients was higher than that in control group after 10-year follow-up. The ages of patients in the death group were greater than those in the survival group. Death-group patients had longer smoking times, higher smoking index, and later onset of COPD symptoms. Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P < 0.01). During 10-year follow-up, 30 patient deaths were recorded (the control group: n = 48; 19 deaths, and intervention group: n = 46; 11 deaths), and patients in the control group had lower survival than those in the intervention group. (P < 0.05).
CONCLUSION
The method of quitting smoking based on cognitive intervention is an effective way for COPD patients to quit smoking successfully. Quitting smoking can slower deterioration in lung function and improve the survival of COPD patients.
CLINICAL TRIAL REGISTRATION NUMBER
ChiCTR2000031239 (Chinese clinical trial registry).",2020,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"['102 COPD patients with a long-term history of smoking from the outpatient clinic were recruited in the study', 'COPD patients', 'chronic obstructive pulmonary disease (COPD) patients']","['tobacco control strategies', 'cognitive intervention containing individual consultation, telephone follow-ups and self-help materials, etc', 'quitting smoking based on cognitive intervention', 'cognitive intervention']","['prevalence of quitting smoking, acute exacerbation (AE), lung function and survival', 'longer smoking times, higher smoking index, and later onset of COPD symptoms', 'higher FEV1/FVC ratio', 'body weight', 'rate of quitting smoking', 'rate of persistent quitting smoking', 'lower survival', 'FEV1/FVC ratio']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",102.0,0.0291403,Death-group patients had lower FEV1% predicted (P < 0.05) and FEV1/FVC ratio (P ,"[{'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Lei', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: leisi0831@csu.edu.cn.'}, {'ForeName': 'Meilei', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 593194666@qq.com.'}, {'ForeName': 'Wenbing', 'Initials': 'W', 'LastName': 'Duan', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 837216794@qq.com.'}, {'ForeName': 'Caiqin', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: 1974546139@qq.com.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: pingchen0731@csu.edu.cn.'}, {'ForeName': 'Shangjie', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Second Xiangya Hospital of Central South University, Research Unit of Respiratory Disease, Central South University, Diagnosis and Treatment Center of Respiratory Disease, Central South University, Changsha, 410011, Hunan, China. Electronic address: wushangjie@csu.edu.cn.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106155']
2014,32958203,Comparison of vasodilatory properties between desflurane and sevoflurane using perfusion index: a randomised controlled trial.,"BACKGROUND
The perfusion index (PI), calculated from the photoplethysmographic waveform, reflects peripheral vasomotor tone. As such, the PI serves as a surrogate for quantitative measures of drug-induced vasoconstriction or vasodilation. This study aimed to compare the effect on the PI of desflurane and sevoflurane at equi-anaesthetic concentrations in patients undergoing single-agent inhalation anaesthesia, where equi-anaesthetic dose was based on the known minimum alveolar concentration of these agents.
METHODS
We randomly allocated patients scheduled for arthroscopic knee surgery to receive either desflurane or sevoflurane general anaesthesia after target-controlled induction of anaesthesia with propofol. Anaesthesia was maintained at age-corrected minimum alveolar concentration 1.0, under neuromuscular block (rocuronium). The PI and haemodynamic data were recorded every minute for 35 min after induction of anaesthesia and after standardised nociceptive stimulation. The primary outcome was PI, compared between the groups over time (repeated-measures analysis of variance). Secondary outcomes included MAP and HR.
RESULTS
Sixty-nine participants (mean [range] age: 42 yr [19-65 yr]; 49% females) were assigned to either desflurane (n=34) or sevoflurane (n=35). The PI remained higher under desflurane compared with sevoflurane, both before (mean difference [MD]: 3.3; 95% confidence intervals [CIs]: 2.0-4.7; P<0.001) and after tetanic stimulation (MD: 2.8; 95% CI: 2.0-3.7; P<0.001). Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22). HR was similar throughout.
CONCLUSIONS
These findings suggest that at equipotent doses, desflurane exerts more potent vasodilatory properties and lowers blood pressure by a magnitude potentially associated with harm.
CLINICAL TRIAL REGISTRATION
NCT03570164.",2020,"Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22).","['patients undergoing single-agent inhalation anaesthesia', 'Sixty-nine participants (mean [range] age: 42 yr [19-65 yr]; 49% females']","['arthroscopic knee surgery', 'desflurane and sevoflurane', 'propofol', 'desflurane or sevoflurane general anaesthesia', 'desflurane anaesthesia', 'desflurane', 'sevoflurane']","['PI and haemodynamic data', 'MAP and HR', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4082765', 'cui_str': 'Arthroscopic knee operation'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C2964282', 'cui_str': 'Perfusion Index'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.368602,"Higher PI paralleled lower MAP in participants assigned to desflurane anaesthesia (P<0.001), both before (MD: 8 mm Hg; 95% CI: 4-12) and after nociceptive stimulation (MD: 14 mm Hg; 95% CI: 7-22).","[{'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Ha', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: hoho4321.lee@daum.net.'}, {'ForeName': 'Jae-Hoon', 'Initials': 'JH', 'LastName': 'Byun', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.07.050']
2015,32960514,Once-Weekly Insulin for Type 2 Diabetes without Previous Insulin Treatment.,"BACKGROUND
It is thought that a reduction in the frequency of basal insulin injections might facilitate treatment acceptance and adherence among patients with type 2 diabetes. Insulin icodec is a basal insulin analogue designed for once-weekly administration that is in development for the treatment of diabetes.
METHODS
We conducted a 26-week, randomized, double-blind, double-dummy, phase 2 trial to investigate the efficacy and safety of once-weekly insulin icodec as compared with once-daily insulin glargine U100 in patients who had not previously received long-term insulin treatment and whose type 2 diabetes was inadequately controlled (glycated hemoglobin level, 7.0 to 9.5%) while taking metformin with or without a dipeptidyl peptidase 4 inhibitor. The primary end point was the change in glycated hemoglobin level from baseline to week 26. Safety end points, including episodes of hypoglycemia and insulin-related adverse events, were also evaluated.
RESULTS
A total of 247 participants were randomly assigned (1:1) to receive icodec or glargine. Baseline characteristics were similar in the two groups; the mean baseline glycated hemoglobin level was 8.09% in the icodec group and 7.96% in the glargine group. The estimated mean change from baseline in the glycated hemoglobin level was -1.33 percentage points in the icodec group and -1.15 percentage points in the glargine group, to estimated means of 6.69% and 6.87%, respectively, at week 26; the estimated between-group difference in the change from baseline was -0.18 percentage points (95% CI, -0.38 to 0.02, P = 0.08). The observed rates of hypoglycemia with severity of level 2 (blood glucose level, <54 mg per deciliter) or level 3 (severe cognitive impairment) were low (icodec group, 0.53 events per patient-year; glargine group, 0.46 events per patient-year; estimated rate ratio, 1.09; 95% CI, 0.45 to 2.65). There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low. Most adverse events were mild, and no serious events were deemed to be related to the trial medications.
CONCLUSIONS
Once-weekly treatment with insulin icodec had glucose-lowering efficacy and a safety profile similar to those of once-daily insulin glargine U100 in patients with type 2 diabetes. (Funded by Novo Nordisk; NN1436-4383 ClinicalTrials.gov number, NCT03751657.).",2020,"There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low.","['patients with type 2 diabetes', 'patients who had not previously received long-term insulin treatment and whose type 2 diabetes was inadequately controlled (glycated hemoglobin level, 7.0 to 9.5%) while taking metformin with or without a dipeptidyl peptidase 4 inhibitor', 'A total of 247 participants']","['icodec or glargine', 'glargine']","['glycated hemoglobin level', 'efficacy and safety', 'episodes of hypoglycemia and insulin-related adverse events', 'level 3 (severe cognitive impairment', 'mean baseline glycated hemoglobin level', 'rates of hypoglycemia with severity of level 2 (blood glucose level', 'insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",247.0,0.321802,"There was no between-group difference in insulin-related key adverse events, and rates of hypersensitivity and injection-site reactions were low.","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Janež', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silver', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'Begtrup', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Hansen', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Jia', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Goldenberg', 'Affiliation': 'From the Dallas Diabetes Research Center at Medical City, Dallas (J.R.); LMC Diabetes and Endocrinology, Brampton (H.S.B.), Leadership Sinai Centre for Diabetes, Mount Sinai Hospital, Toronto (H.S.B.), and LMC Diabetes and Endocrinology, Vaughan (R.G.) - all in Ontario, Canada; the Department of Endocrinology, Diabetes, and Metabolic Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia (A.J.); Southern New Hampshire Diabetes and Endocrinology, Nashua (R.S.); and Novo Nordisk, Søborg, Denmark (K.B., M.V.H., T.J.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2022474']
2016,32965537,"Author's Reply to Letters to the Editor: ""A comparison of endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty for repairing medium- to large-sized tympanic membrane perforation: a randomized clinical trial"".",,2020,,[],['endoscopic transtympanic myringoplasty and endoscopic type I tympanoplasty'],[],[],"[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0442388', 'cui_str': 'Transtympanic approach'}, {'cui': 'C0027136', 'cui_str': 'Myringoplasty'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]",[],,0.0406288,,"[{'ForeName': 'Viraporn', 'Initials': 'V', 'LastName': 'Atchariyasathian', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand. viraporn.a@psu.ac.th.'}, {'ForeName': 'Rata', 'Initials': 'R', 'LastName': 'Suwannajak', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Yuvatiya', 'Initials': 'Y', 'LastName': 'Plodpai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Pittayapon', 'Initials': 'P', 'LastName': 'Pitathawatchai', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, 90110, Thailand.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06376-y']
2017,32963047,"A randomised, double-blind, placebo-controlled, 24-week, phase II, proof-of-concept study of romilkimab (SAR156597) in early diffuse cutaneous systemic sclerosis.","OBJECTIVES
Recent advances in systemic sclerosis (SSc) show that it involves a T-helper type-2-oriented immune response with interleukin (IL)-4 and IL-13. Romilkimab is an engineered, humanised, bispecific immunoglobulin-G4 antibody that binds and neutralises IL-4/IL-13 making it ideal for exploration in fibrosis.
METHODS
Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy, were randomised (1:1) to subcutaneous romilkimab 200 mg or placebo one time per week for 24 weeks in this double-blind, proof-of-concept, phase II study. The primary endpoint was change in modified Rodnan skin score (mRSS) from baseline to week 24.
RESULTS
Ninety-seven patients were randomised to romilkimab (n=48) or placebo (n=49) for 24 weeks. Least-squares mean (SE) change in mRSS was -4.76 (0.86) for romilkimab versus -2.45 (0.85) for placebo yielding a mean (SE) (90% CI) difference of -2.31 (1.21) (-4.32 to -0.31; p=0.0291, one-sided). Treatment-emergent AEs were balanced between placebo (n=41; 84%) and romilkimab (n=40; 80%). Most were mild-to-moderate and discontinuations were low (three overall). There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related. Two patients in the placebo group had a cardiovascular treatment-emergent SAE (one cardiac failure, one cardiomyopathy), but there were no cardiac safety signals with romilkimab.
CONCLUSION
This study demonstrated significant effects on skin changes with romilkimab in early dcSSc that require confirmation with a longer and more comprehensive phase III study to determine clinical relevance.
TRIAL REGISTRATION NUMBER
NCT02921971.",2020,"There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related.","['early diffuse cutaneous systemic sclerosis', 'Patients aged ≥18 years diagnosed with diffuse cutaneous SSc (dcSSc), and with or without immunosuppressive background therapy', 'Ninety-seven patients']","['romilkimab (SAR156597', 'placebo', 'subcutaneous romilkimab 200\u2009mg or placebo', 'romilkimab']","['cardiovascular treatment-emergent SAE (one cardiac failure, one cardiomyopathy', 'deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo', 'modified Rodnan skin score (mRSS', 'Least-squares mean (SE) change in mRSS']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439073', 'cui_str': '97'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1262147', 'cui_str': 'Scleroderma renal crisis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",97.0,0.626656,"There were two deaths (one scleroderma renal crisis (romilkimab) and one cardiomyopathy (placebo)), neither were considered treatment related.","[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Allanore', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Paris Descartes University, Paris, France yannick.allanore@cch.aphp.fr.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wung', 'Affiliation': 'Sanofi R&D, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Soubrane', 'Affiliation': 'Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Esperet', 'Affiliation': 'Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Marrache', 'Affiliation': 'Immunology and Inflammation, Sanofi R&D, Chilly-Mazarin, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Bejuit', 'Affiliation': 'Statistics and Programming, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Lahmar', 'Affiliation': 'Global Safety, Sanofi R&D, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Rheumatology Clinic, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Centre for Rheumatology and and Connective Tissue Diseases, University College London Division of Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218447']
2018,32947067,Perspectives of patients and health professionals on important factors influencing rehabilitation following acute pulmonary embolism: A multi-method study.,"BACKGROUND
International guidelines on pulmonary embolism (PE) management and rehabilitation have recently been published. However, the contained recommendation about an efficient follow-up strategy after PE is difficult for health care professionals to implement because limited research exists about what strategies are efficient.
OBJECTIVES
The study aimed to 1) describe and explore perspectives and experiences of health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions.
PATIENTS/METHODS
The study was a multi-method study, nested in a larger randomized controlled trial, combining data from two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention.
RESULTS
Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations. In terms of rehabilitation, repeatedly testing physical performance, resuming exercise under the guidance and support of specialized personnel, and access to peer support, were considered important for increasing motivation and self-efficacy for engaging in physical activity again.
CONCLUSIONS
This study offers suggestions for key elements to include in post-PE management and rehabilitation interventions, as well as the structuring of care. However, research still needs to be undertaken before solid recommendations for the content and structure of successful post-PE management and rehabilitation can be given.",2020,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","['two focus group interviews with 10 HCPs, 16 individual interviews with patients, data from exercise diaries and logbooks from HCPs participating in a rehabilitation intervention', 'acute pulmonary embolism']","['health care professionals (HCPs) and patients participating in a post-PE rehabilitation intervention, and 2) provide suggestions for future post-PE management and rehabilitation interventions']",[],"[{'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2882221', 'cui_str': 'Acute pulmonary embolism'}]","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.070874,"Key factors for successful post-PE management, considered important for reducing anxiety and confusion by both patients and HCPs, were the presence of a multidisciplinary specialized team, initiation of management shortly after discharge, and having regular follow-ups, e.g. telephone consultations.","[{'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Rolving', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark; DEFACTUM, Corporate Quality, Central Denmark Region, Aarhus, Denmark. Electronic address: Nanna.Rolving@rm.dk.'}, {'ForeName': 'Jannie Rhod', 'Initials': 'JR', 'LastName': 'Bloch-Nielsen', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Barbara Christina', 'Initials': 'BC', 'LastName': 'Brocki', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Andreasen', 'Affiliation': 'Department of Physical and Occupational Therapy, Aalborg University Hospital, Aalborg, Denmark; Public Health and Epidemiology Group, Department of Health, Science and Technology, Aalborg University, Denmark.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.016']
2019,32947455,Adjuvant Guided Exercise Therapy Versus Self-Organized Activity in Patients With Major Depression.,"Exercise seems to be effective in reducing depression itself, as well as the risk of relapse. This study evaluated whether standardized guided exercise therapy (GET) in comparison with self-organized activity (SOA) is an effective augmentation therapy in depressive adults. A total of 111 inpatients (66.7% women; mean age, 45.05 ± 12.19 years) with major depression were randomly assigned to either GET or SOA. Interventions were performed three times a week, with each session lasting 50 minutes. Both GET and SOA exerted effects even after a short-term application of 6 weeks. GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027). The findings support the beneficial role of adjuvant GET in patients with major depression as a feasible treatment in a psychiatric short-term inpatient setting.",2020,"GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027).","['patients with major depression', 'depressive adults', 'Patients With Major Depression', '111 inpatients (66.7% women; mean age, 45.05 ± 12.19 years) with major depression']","['Adjuvant Guided Exercise Therapy Versus Self-Organized Activity', 'GET or SOA', 'self-organized activity (SOA', 'standardized guided exercise therapy (GET']","['depression symptom severity', 'improving suicidality', 'Hamilton Depression Scale', 'severity of diurnal variation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}]",111.0,0.0157758,"GET was superior to SOA in reducing depression symptom severity, as measured by the Hamilton Depression Scale (p = 0.017), specifically improving suicidality (p = 0.028) as well as time (p = 0.003) and severity of diurnal variation (p = 0.027).","[{'ForeName': 'Ida S', 'Initials': 'IS', 'LastName': 'Haussleiter', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Bolsinger', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Hans-Jörg', 'Initials': 'HJ', 'LastName': 'Assion', 'Affiliation': 'LWL Hospital Dortmund, Dortmund, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Juckel', 'Affiliation': 'Department of Psychiatry.'}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001240']
2020,32947480,"The 11th Trial of a Cardiovascular Clinical Trialist - Coronavirus-2, Part 3.",,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000349']
2021,32947994,A Pilot Evaluation of a Smartphone Application for Workplace Depression.,"Interventions delivered via mobile apps show particular promise in tackling the burden of common mental disorders. Appropriately targeting these interventions to at-risk populations is critical to their success. This pilot study aimed to assess the usability, feasibility, acceptability, and preliminary effects of an app-based intervention designed to target depressive symptoms in a stressed working population. Anchored, a smartphone app including a 30-day program of mindfulness and cognitive and behavioural therapeutic components, was tested in a pre-post pilot study with participants recruited via social media advertisements. Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure. Follow-up assessment occurred 5 weeks after baseline. The primary outcome measure was change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance. User feedback and in-app data were analysed to assess engagement and intervention adherence. At follow-up, there were significant reductions in depressive symptoms (t 61 = 6.35; p < 0.001) and anxiety symptoms (t 60 = 7.35; p < 0.001), along with significantly reduced cases of likely new onset depression compared to baseline (24% vs. 6%, p = 0.012). Significant improvements were also seen in wellbeing (t 60 = -5.64; p < 0.001), resilience (t 60 = -3.89; p < 0.001), stress (t 61 = 11.18; p < 0.001), and alcohol use (t 60 = 3.40; p = 0.001). Participants reported no significant changes in work performance, absenteeism or exercise. There were satisfactory levels of app usability, feasibility, and acceptability. Most participants found the app easy to use (93.2%), understood the app content well (83.0%), and rated the app highly or very highly overall (72.9%). User feedback suggestions were predominantly focused on improving app navigation and user interface. This pilot study provides encouraging evidence that Anchored has potentially beneficial effects, and is usable, feasible, and acceptable as an app-based intervention for the working population experiencing elevated stress. Further testing of Anchored in a randomised controlled trial is required to investigate its efficacy as an intervention for workplace mental ill-health.",2020,"Significant improvements were also seen in wellbeing (t 60 = -5.64; p < 0.001), resilience (t 60 = -3.89; p < 0.001), stress (t 61 = 11.18; p < 0.001), and alcohol use (t 60 = 3.40; p = 0.001).","['Eligible participants (N = 81) were Australian adults who were employed and reported elevated stress levels on a single-item screening measure', 'stressed working population', 'participants recruited via social media advertisements', 'Workplace Depression', 'workplace mental ill-health']",['Smartphone Application'],"['wellbeing', 'usability, feasibility, acceptability', 'anxiety symptoms', 'change in depressive symptoms, with secondary outcomes measuring change in anxiety, wellbeing, stress, resilience, exercise, alcohol use, absenteeism, and work performance', 'satisfactory levels of app usability, feasibility, and acceptability', 'work performance, absenteeism or exercise', 'depressive symptoms', 'new onset depression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",81.0,0.281056,"Significant improvements were also seen in wellbeing (t 60 = -5.64; p < 0.001), resilience (t 60 = -3.89; p < 0.001), stress (t 61 = 11.18; p < 0.001), and alcohol use (t 60 = 3.40; p = 0.001).","[{'ForeName': 'Daniel A J', 'Initials': 'DAJ', 'LastName': 'Collins', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Samuel B', 'Initials': 'SB', 'LastName': 'Harvey', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Isobel', 'Initials': 'I', 'LastName': 'Lavender', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Glozier', 'Affiliation': 'Brain and Mind Centre, Central Clinical School, Faculty of Medicine and Health, University of Sydney,Sydney, NSW 2050, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Deady', 'Affiliation': 'Black Dog Institute, Faculty of Medicine, University of New South Wales, Randwick, NSW 2031, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17186753']
2022,32950920,The effect of marker size on three-dimensional motion analysis of the foot.,"BACKGROUND
In the field of three-dimensional motion analysis of the foot, there is little agreement on the preferred size of markers to record kinematic parameters. Although currently applied marker sizes show a considerable range, there has been no detailed investigation of the effect of marker size on the calculation of foot kinematics in the current literature.
RESEARCH QUESTION
The objective of this research was to determine whether marker size impacts essential parameters that describe foot biomechanics.
METHODS
Seventeen subjects participated in this randomized repeatability study. All participants had to walk on a treadmill twice to test two sets of markers (set A: small marker, 9.5 mm, 1 g; set B: large marker, 14 mm, 2 g). Three-dimensional motion capturing was used to record the trajectories of the markers. The spatial relation of the markers, as well as vertical motion of the navicular bone and the angle of the medial longitudinal arch were calculated based on the marker trajectories. In addition to motion capturing, skin rigidity was quantified by applying an oscillatory shear force to the skin. Analysis of variance, root-mean-square error calculations and linear fit methods were applied to evaluate effects of marker size on the calculation of foot kinematics and the impact of skin rigidity.
RESULTS
The estimated foot kinematics appeared to be unaffected by the size of the markers. Further, there was no evidence that skin rigidity influenced the error of the marker trajectories. Interestingly, the large markers fell off more frequently.
SIGNIFICANCE
The findings will be of interest to those who use marker-based three-dimensional motion capturing, especially to analyze foot biomechanics. Although the calculation of kinematic parameters appears to be unaffected by marker size, practical aspects, like accidental marker loss, favor the application of small markers.",2020,The estimated foot kinematics appeared to be unaffected by the size of the markers.,['Seventeen subjects participated'],[],"['estimated foot kinematics', 'skin rigidity']","[{'cui': 'C0450331', 'cui_str': '17'}]",[],"[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}]",17.0,0.0404244,The estimated foot kinematics appeared to be unaffected by the size of the markers.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Ebrecht', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany. Electronic address: florian.ebrecht@hsw.tu-chemnitz.de.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Sichting', 'Affiliation': 'Department of Human Locomotion, Chemnitz University of Technology, Straße der Nationen 62, 09111 Chemnitz, Germany.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.007']
2023,32956960,Mental health promotion and prevention interventions in families with parental depression: A randomized controlled trial.,"BACKGROUND
The transgenerational transmission of affective disorders calls for integrating promotion of child development in the services offered to families with parental depression. The main objective of the present research was to examine the effectiveness and differences in the impact of two relevant interventions in Greece.
METHODS
Thirty families of depressed patients were randomly assigned to the six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session Let's Talk about the Children group. Depressed parents and the eldest of their children were assessed prior to the interventions and 4, 10, and 18 months following baseline assessment.
RESULTS
In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems. Child's prosocial behavior, perceived social support, and health-related quality of life were significantly improved in both groups. All positive effects were evident four months following baseline assessment and could be still documented at 1.5-year follow-up. Mixed linear models showed that family functioning and parenting to a lesser extent were associated with the greatest changes in children's psychosocial outcomes in both interventions..
LIMITATIONS
The lack of data regarding parents that refused to receive the interventions may limit generalizability of results. A further limitation is the lack of a no-intervention control group.
CONCLUSIONS
The study offers a preliminary evidence base for integrating preventive interventions for child mental health in routine clinical practice with adult depressed patients.",2021,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","['families with parental depression', 'Thirty families of depressed patients', 'child mental health in routine clinical practice with adult depressed patients']","['Mental health promotion and prevention interventions', 'six-to-eight session Family Talk Intervention group and 32 families were included in the lower intensity parent-only two-to-three session']","[""parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems"", ""Child's prosocial behavior, perceived social support, and health-related quality of life""]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0184645', 'cui_str': 'Mental health promotion'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0680051', 'cui_str': 'Family functioning capacity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",32.0,0.0624,"In both groups there were significant improvements in parent's depression, anxiety, perceived social support, parenting and family functioning, as well as improvements in child's depression, anxiety, and child emotional/behavioral problems.","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Giannakopoulos', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece. Electronic address: ggiannak@med.uoa.gr.'}, {'ForeName': 'Tytti', 'Initials': 'T', 'LastName': 'Solantaus', 'Affiliation': 'MIELI Mental Health Finland, Helsinki, Finland; Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Chara', 'Initials': 'C', 'LastName': 'Tzavara', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Kolaitis', 'Affiliation': 'Department of Child Psychiatry, School of Medicine, National and Kapodistrian University of Athens, ""Aghia Sophia"" Children\'s Hospital, Athens, Greece.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.070']
2024,32958702,Early Intervention with Lenalidomide in Patients with High-risk Chronic Lymphocytic Leukemia.,"PURPOSE
Infectious complications constitute a leading cause of morbidity and mortality in chronic lymphocytic leukemia (CLL). Patients respond poorly to vaccines, particularly pneumococcal polysaccharide and influenza vaccines. In addition, patients with genetically high-risk disease are at increased risk for early disease progression and death. Lenalidomide, an oral immunomodulatory agent with demonstrated clinical activity in CLL, can potentially restore immune system dysfunction associated with CLL while improving disease outcomes.
PATIENTS AND METHODS
Phase II study randomized 49 patients with genetically high-risk CLL or small lymphocytic lymphoma [SLL; defined as unmutated Ig heavy chain variable region, deletion(17p) or (11q), and/or complex abnormal karyotype], to receive lenalidomide either concurrent (arm A) or sequential to (arm B) two doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13) administered 2 months apart, in patients not meeting International Workshop on Chronic Lymphocytic Leukemia treatment criteria.
RESULTS
Four serotypes (3, 4, 5, 6B) achieved the additional seroprotection definition of a fourfold increase in arm A, and six serotypes (3, 4, 5, 6B, 19A, 19F) in arm B. All patients achieved the defined concentration of 0.35 μg/mL for at least one serotype tested. No significant difference was observed with the addition of lenalidomide. At median time on treatment of 3.6 years, median progression-free survival (PFS) was 5.8 years [95% confidence interval (CI), 3.1-not reached]. PFS at 1, 2, and 3 years was 85% (95% CI, 72-93), 79% (95% CI, 64-88), and 72% (95% CI, 57-83), respectively.
CONCLUSIONS
Lenalidomide is efficacious with manageable toxicities as an early intervention strategy in patients with high-risk CLL, but did not enhance humoral response to PCV13 vaccine.",2020,"PFS at 1, 2 and 3 year was 85% (95% CI 72-93), 79% (64-88), and 72% (95% CI 57-83) respectively.
","['chronic lymphocytic leukemia (CLL', '49 patients with genetically high-risk CLL or SLL (defined as unmutated IGHV, deletion(17p) or (11q), and/or complex abnormal karyotype', 'patients with high-risk chronic lymphocytic leukemia', 'patients with high-risk CLL', 'patients with genetically high risk disease']","['lenalidomide', 'lenalidomide either concurrent (Arm A) or sequential to (Arm B) 2 doses of 13-valent protein-conjugated pneumococcal vaccine (PCV13', 'Lenalidomide']","['risk for early disease progression and death', 'additional seroprotection definition', 'PFS', 'median PFS']","[{'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0855095', 'cui_str': 'Malignant lymphoma, small lymphocytic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0476431', 'cui_str': 'Karyotype evaluation abnormal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",49.0,0.160773,"PFS at 1, 2 and 3 year was 85% (95% CI 72-93), 79% (64-88), and 72% (95% CI 57-83) respectively.
","[{'ForeName': 'Shanmugapriya', 'Initials': 'S', 'LastName': 'Thangavadivel', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Qiuhong', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Narendranath', 'Initials': 'N', 'LastName': 'Epperla', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Rike', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Xiaokui', 'Initials': 'X', 'LastName': 'Mo', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Badawi', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Darlene M', 'Initials': 'DM', 'LastName': 'Bystry', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Mitch A', 'Initials': 'MA', 'LastName': 'Phelps', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Andritsos', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Kerry A', 'Initials': 'KA', 'LastName': 'Rogers', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Division of Hematology, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio. farrukh.awan@utsouthwestern.edu john.byrd@osumc.edu.'}, {'ForeName': 'Farrukh T', 'Initials': 'FT', 'LastName': 'Awan', 'Affiliation': 'Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas. farrukh.awan@utsouthwestern.edu john.byrd@osumc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1280']
2025,32959203,Effectiveness of an intensive care unit family education intervention on delirium knowledge: a pre-test post-test quasi-experimental study.,"PURPOSE
To create, validate, and refine an intensive care unit (ICU) delirium education intervention to prepare family members to partner with the ICU care team to detect delirium symptoms and prevent and manage delirium using nonpharmacological strategies.
METHODS
In this pre-test post-test quasi-experimental study, consecutive eligible family members of critically ill patients admitted to an ICU completed an ICU Family Education Delirium intervention in two parts: 1) six-minute video on ICU delirium (risk factors, prevention/management, symptoms, communication with the ICU care team), and 2) two case vignettes to practice detecting delirium using family-administered delirium detection questionnaires (Family Confusion Assessment Method [FAM-CAM] and Sour Seven). Family members' delirium knowledge was measured before, immediately after, and two weeks following the intervention using the Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ).
RESULTS
Of 99 family members recruited over eight months, 81 (82%) completed the intervention and 63 (63/81, 78%) completed all follow-up questionnaires. Family members' delirium knowledge improved significantly following the intervention (pre-CIDKQ, 14; 95% confidence interval [CI], 13 to 15; post-CIDKQ, 17; 95% CI, 16 to 17; P < 0.001) and was retained two weeks after the intervention (CIDKQ 16; 95% CI, 16 to 17; P < 0.001). This included increased knowledge regarding delirium risk factors (e.g., medication, mechanical ventilation), prevention/management (e.g., orientation, day/night routine), and symptoms of delirium. More family members correctly detected delirium symptoms in case vignettes using the Sour Seven (92%) compared with the FAM-CAM (78%).
CONCLUSIONS
A video-based ICU delirium education intervention is effective in educating family members about prevention, detection, and management of delirium.",2020,"More family members correctly detected delirium symptoms in case vignettes using the Sour Seven (92%) compared with the FAM-CAM (78%).
","['Of 99 family members recruited over eight months, 81 (82%) completed the intervention and 63 (63/81, 78%) completed all follow-up questionnaires', 'consecutive eligible family members of critically ill patients admitted to an ICU completed an ICU Family Education Delirium intervention in two parts: 1']","['intensive care unit (ICU) delirium education intervention', 'video-based ICU delirium education intervention', 'six-minute video on ICU delirium (risk factors, prevention/management, symptoms, communication with the ICU care team), and 2) two case vignettes to practice detecting delirium using family-administered delirium detection questionnaires (Family Confusion Assessment Method [FAM-CAM] and Sour Seven', 'intensive care unit family education intervention']","['delirium knowledge', 'Caregiver ICU Delirium Knowledge Questionnaire (CIDKQ', 'delirium symptoms', 'knowledge regarding delirium risk factors (e.g., medication, mechanical ventilation), prevention/management (e.g., orientation, day/night routine), and symptoms of delirium']","[{'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0150577', 'cui_str': 'Education of family'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449719', 'cui_str': 'Part'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4524095', 'cui_str': 'Intensive care unit delirium'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0060056', 'cui_str': 'FAM protocol'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0150577', 'cui_str': 'Education of family'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C4524095', 'cui_str': 'Intensive care unit delirium'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]",,0.0437768,"More family members correctly detected delirium symptoms in case vignettes using the Sour Seven (92%) compared with the FAM-CAM (78%).
","[{'ForeName': 'Karla D', 'Initials': 'KD', 'LastName': 'Krewulak', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services& University of Calgary, Ground Floor, McCaig Tower, 3134 Hospital Drive NW, Calgary, AB, T2N 5A1, Canada.'}, {'ForeName': 'Margaret J', 'Initials': 'MJ', 'LastName': 'Bull', 'Affiliation': 'College of Nursing, Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Wesley Ely', 'Affiliation': ""Tennessee Valley Veteran's Affairs Geriatric Research Education Clinical Center (VA GRECC), Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center, Vanderbilt University Medical Center, Nashville, TN, USA.""}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Davidson', 'Affiliation': 'Department of Education, Development and Research, University of California, San Diego Health, San Diego, CA, USA.'}, {'ForeName': 'Henry T', 'Initials': 'HT', 'LastName': 'Stelfox', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services& University of Calgary, Ground Floor, McCaig Tower, 3134 Hospital Drive NW, Calgary, AB, T2N 5A1, Canada.'}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Fiest', 'Affiliation': 'Department of Critical Care Medicine, Alberta Health Services& University of Calgary, Ground Floor, McCaig Tower, 3134 Hospital Drive NW, Calgary, AB, T2N 5A1, Canada. kmfiest@ucalgary.ca.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01810-5']
2026,32959291,Psychedelische Trips - auf Placebo! : Schlaganfallrisiko.,,2020,,[],[],[],[],[],[],,0.181712,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hüll', 'Affiliation': 'Klinik für Geronto- und Neuropsychiatrie, Neubronnstraße 25, 79312, Emmendingen, Deutschland. m.huell@zfp-emmendingen.de.'}]",MMW Fortschritte der Medizin,['10.1007/s15006-020-4377-9']
2027,32959996,"Two-year outcomes of Whānau Pakari, a multi-disciplinary assessment and intervention for children and adolescents with weight issues: A randomized clinical trial.","OBJECTIVE
To determine whether 12-month BMI SDS reductions persisted at 24 months in a multi-disciplinary assessment and intervention program for children and adolescents with obesity, and whether secondary outcomes improved.
METHODS
This was a community-based 12-month RCT in Aotearoa/New Zealand. Eligible participants were aged 5 to 16 years with BMI ≥98th centile or BMI >91st centile with weight-related comorbidities. The low-intensity control received comprehensive home-based baseline assessments and advice, and 6-monthly follow-up. The high-intensity intervention received the same assessments and advice, but also weekly multidisciplinary sessions. Primary outcome was BMI SDS at 12 months. Secondary outcomes included cardiovascular and metabolic markers.
RESULTS
121 participants (60% of participants at baseline) were assessed at 24 months. BMI SDS reduction at 12 months was lost at 24 months in the modified intention-to-treat analysis [Control -0.03 (95%CI -0.14, 0.09) and Intervention -0.02 (-0.12, 0.08); P = .93]. However, sweet drink intake was reduced, water intake increased, and there were improvements in cardiovascular fitness in the high-intensity intervention. ≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06).
CONCLUSIONS
This trial was negative in terms of primary outcome at 24 months. However, high engagement led to sustained treatment effect, and there were multiple improvements in health measures.",2021,"≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06).
","['Eligible participants were aged 5 to 16\u2009years with BMI ≥98th centile or BMI\u2009>91st centile with weight-related comorbidities', '121 participants (60% of participants at baseline) were assessed at 24\u2009months', 'children and adolescents with weight issues', 'children and adolescents with obesity']","['Whānau Pakari, a multi-disciplinary assessment and intervention']","['health measures', 'persistent BMI SDS reduction', 'cardiovascular and metabolic markers', 'BMI SDS', 'water intake', 'cardiovascular fitness', 'BMI SDS reductions', 'BMI SDS reduction']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}]",121.0,0.220363,"≥70% attendance in the high-intensity intervention resulted in a persistent BMI SDS reduction of -0.22 after 24 months (95%CI -0.38, -0.06).
","[{'ForeName': 'Yvonne C', 'Initials': 'YC', 'LastName': 'Anderson', 'Affiliation': 'Department of Paediatrics, Taranaki District Health Board, New Plymouth, New Zealand.'}, {'ForeName': 'Lisa E', 'Initials': 'LE', 'LastName': 'Wynter', 'Affiliation': 'Department of Paediatrics, Taranaki District Health Board, New Plymouth, New Zealand.'}, {'ForeName': 'Niamh A', 'Initials': 'NA', 'LastName': ""O'Sullivan"", 'Affiliation': 'Department of Paediatrics, Taranaki District Health Board, New Plymouth, New Zealand.'}, {'ForeName': 'Cervantée E K', 'Initials': 'CEK', 'LastName': 'Wild', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Cameron C', 'Initials': 'CC', 'LastName': 'Grant', 'Affiliation': 'Department of Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tami L', 'Initials': 'TL', 'LastName': 'Cave', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'José G B', 'Initials': 'JGB', 'LastName': 'Derraik', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}]",Pediatric obesity,['10.1111/ijpo.12693']
2028,31813028,Ejaculatory disorders after prostatic artery embolization: a reassessment of two prospective clinical trials.,"PURPOSE
This study aims to specify and explain the previous findings of unexpectedly high rates of ejaculatory disorders, i.e. 56%, found after prostatic artery embolization (PAE) in a randomized controlled trial comparing safety and efficacy of PAE and transurethral resection of the prostate (TURP).
PATIENTS AND METHODS
Case report forms of the randomized controlled trial were analyzed to specify the grade of postoperative ejaculatory dysfunction 3 months postoperatively. In addition, study participants with assessable ejaculation were asked to complete the four-item Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD) referring to their ejaculatory function at present, as well as before treatment and 3 months after. Potential explanations for ejaculatory disorders after PAE were derived from histological examination of five radical prostatectomy specimens of patients that underwent PAE 6 weeks before radical prostatectomy within a proof-of-concept trial at the study site, St. Gallen Cantonal Hospital. An experienced uropathologist systematically examined the whole-gland embedded tissue with focus on structures that are involved into ejaculation.
RESULTS
While patients after TURP predominantly suffered from anejaculation (52%), diminished ejaculation was found more often after PAE (40%). Significantly higher MSHQ-EjD scores were found 3 months after PAE and at a median follow-up of 31 months. Histological examination showed marked changes of structures involved into ejaculation (e.g., prostatic glands, seminal vesicles, ejaculatory ducts) after PAE.
CONCLUSION
Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.",2020,"Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.","['participants with assessable ejaculation', 'Ejaculatory disorders after prostatic artery embolization']","['prostatic artery embolization (PAE', 'PAE and transurethral resection of the prostate (TURP', 'TURP']","['MSHQ-EjD scores', 'ejaculation', 'Male Sexual Health Questionnaire-Ejaculation Dysfunction Short Form (MSHQ-EjD) referring to their ejaculatory function', 'structures involved into ejaculation (e.g., prostatic glands, seminal vesicles, ejaculatory ducts']","[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0397760', 'cui_str': 'Embolization of artery'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0235969', 'cui_str': 'Disorder of ejaculation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C0013747', 'cui_str': 'Ejaculatory duct structure'}]",,0.0316888,"Although anejaculation occurs less frequently after PAE (16%) compared to TURP (52%), patients have to be informed about the relevant risk of ejaculatory disorders, especially diminished ejaculation.","[{'ForeName': 'Gautier', 'Initials': 'G', 'LastName': 'Müllhaupt', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland. gautier.muellhaupt@kssg.ch.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hechelhammer', 'Affiliation': 'Department of Radiology and Nuclear Medicine, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Pierre-André', 'Initials': 'PA', 'LastName': 'Diener', 'Affiliation': 'Department of Pathology, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Engeler', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Güsewell', 'Affiliation': 'Clinical Trials Unit, St. Gallen Cantonal Hospital, St. Gallen, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Schmid', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Mordasini', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Abt', 'Affiliation': 'Department of Urology, St. Gallen Cantonal Hospital, Rorschacherstrasse 95, 9007, St. Gallen, Switzerland.'}]",World journal of urology,['10.1007/s00345-019-03036-7']
2029,32961507,The effects of acute work stress and appraisal on psychobiological stress responses in a group office environment.,"BACKGROUND
The high prevalence of office stress and its detrimental health consequences are of concern to individuals, employers and society at large. Laboratory studies investigating office stress have mostly relied on data from participants that were tested individually on abstract tasks. In this study, we examined the effect of psychosocial office stress and work interruptions on the psychobiological stress response in a realistic but controlled group office environment. We also explored the role of cognitive stress appraisal as an underlying mechanism mediating the relationship between work stressors and the stress response.
METHODS AND MATERIALS
Ninety participants (44 female; mean age 23.11 ± 3.80) were randomly assigned to either a control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting. To induce psychosocial stress, we adapted the Trier Social Stress Test for Groups to an office environment. Throughout the experiment, we continuously monitored heart rate and heart rate variability. Participants repeatedly reported on their current mood, calmness, wakefulness and perceived stress and gave saliva samples to assess changes in salivary cortisol and salivary alpha-amylase. Additionally, cognitive appraisal of the psychosocial stress test was evaluated.
RESULTS
Our analyses revealed significant group differences for most outcomes during or immediately after the stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate). Interestingly, the condition that experienced work interruptions showed a higher increase of cortisol levels but appraised the stress test as less threatening than individuals that experienced only psychosocial stress. Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
DISCUSSION
The results showed that experimentally induced work stress led to significant responses of subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system. However, there appears to be a discrepancy between the psychological and biological responses to preceding work interruptions. Appraising psychosocial stress as less threatening but still as challenging could be an adaptive way of coping and reflect a state of engagement and eustress.",2020,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
",['Ninety participants (44 female; mean age 23.11 ± 3.80'],['control condition or one of two experimental conditions in which they were exposed to psychosocial stress with or without prior work interruptions in a realistic multi-participant laboratory setting'],"['heart rate and heart rate variability', 'stress test (i.e., mood, calmness, perceived stress, salivary cortisol, heart rate, heart rate variability) and during recovery (i.e., salivary cortisol and heart rate', 'psychobiological stress responses', 'psychobiological stress response', 'subjective measures of stress, the hypothalamic-pituitary-adrenal axis and the autonomic nervous system', 'cortisol levels', 'current mood, calmness, wakefulness and perceived stress and gave saliva samples', 'salivary cortisol and salivary alpha-amylase']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}]",90.0,0.0154888,"Exploratory mediation analyses revealed a blunted response in subjective measures of stress, which was partially explained by the differences in threat appraisal.
","[{'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Kerr', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland. Electronic address: jkerr@ethz.ch.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Naegelin', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Raphael P', 'Initials': 'RP', 'LastName': 'Weibel', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ferrario', 'Affiliation': 'Mobiliar Lab for Analytics, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland; Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'La Marca', 'Affiliation': 'Chair of Clinical Psychology and Psychotherapy, Department of Psychology, University of Zurich, Binzmuehlestrasse 14, 8050 Zurich, Switzerland; Clinica Holistica Engiadina, Plaz 40, 7542 Susch, Switzerland.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Wangenheim', 'Affiliation': 'Chair of Technology Marketing, Department of Management, Technology, and Economics, ETH Zurich, Weinbergstrasse 56/58, 8092 Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoelscher', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland.'}, {'ForeName': 'Victor R', 'Initials': 'VR', 'LastName': 'Schinazi', 'Affiliation': 'Chair of Cognitive Science, Department of Humanities, Social and Political Sciences, ETH Zurich, Clausiusstrasse 59, 8092 Zurich, Switzerland; Department of Psychology, Bond University, 14 University Drive, Robina Queensland 4226, Australia.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104837']
2030,32961528,A Randomized Controlled Trial of Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis.,"OBJECTIVES
To test whether administration of prasugrel after coronary artery bypass grafting (CABG) reduces saphenous vein graft (SVG) thrombosis. Use of aspirin after CABG improves graft patency, but administration of other antiplatelet agents has yielded equivocal results.
METHODS
We performed a double-blind trial randomizing patients to prasugrel or placebo after CABG at four United States centers. Almost all patients were receiving aspirin. Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS) were performed at 12 months. The primary efficacy endpoint was prevalence of OCT-detected SVG thrombus. The primary safety endpoint was incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding.
RESULTS
The study was stopped early due to slow enrollment after randomizing 84 patients. Mean age was 64 ± 6 years; 98% of the patients were men. Follow-up angiography was performed in 59 patients. IVUS was performed in 52 patients, OCT in 53 patients, and NIRS in 33 patients. Thrombus was identified by OCT in 56% vs 50% of patients in the prasugrel vs placebo groups, respectively (P=.78). Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19). The 1-year incidence of major adverse cardiovascular events was 14.3% vs 2.4% in the prasugrel and placebo groups, respectively (P=.20), without significant differences in GUSTO severe bleeding (P=.32).
CONCLUSION
Early SVG failure occurred in approximately one-third of patients. Prasugrel did not decrease prevalence of SVG thrombus 12 months after CABG.",2020,Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19).,"['after CABG at four United States centers', '59 patients', 'Mean age was 64 ± 6 years; 98% of the patients were men', 'Early Saphenous Vein Graft Thrombosis']","['prasugrel after coronary artery bypass grafting (CABG', 'IVUS', 'prasugrel or placebo', 'Follow-up angiography, optical coherence tomography (OCT), intravascular ultrasound (IVUS), and near-infrared spectroscopy (NIRS', 'placebo', 'Prasugrel', 'aspirin']","['Angiographic SVG failure', 'saphenous vein graft (SVG) thrombosis', '1-year incidence of major adverse cardiovascular events', 'GUSTO severe bleeding', 'graft patency', 'prevalence of OCT-detected SVG thrombus', 'Early SVG failure', 'incidence of Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) severe bleeding']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0729538', 'cui_str': 'Saphenous vein graft'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038418', 'cui_str': 'Streptokinase'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",59.0,0.37887,Angiographic SVG failure occurred in 24% of patients in the prasugrel arm vs 40% in the placebo arm (P=.19).,"[{'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Danek', 'Affiliation': ''}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Karatasakis', 'Affiliation': ''}, {'ForeName': 'Kazeen', 'Initials': 'K', 'LastName': 'Abdullah', 'Affiliation': ''}, {'ForeName': 'Rahel', 'Initials': 'R', 'LastName': 'Iwnetu', 'Affiliation': ''}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Kalsaria', 'Affiliation': ''}, {'ForeName': 'Kendrick', 'Initials': 'K', 'LastName': 'Shunk', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zimmet', 'Affiliation': ''}, {'ForeName': 'Mladen', 'Initials': 'M', 'LastName': 'Vidovich', 'Affiliation': ''}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Bavry', 'Affiliation': ''}, {'ForeName': 'Bavana V', 'Initials': 'BV', 'LastName': 'Rangan', 'Affiliation': ''}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Roesle', 'Affiliation': ''}, {'ForeName': 'Decebal', 'Initials': 'D', 'LastName': 'Griza', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Stanley', 'Affiliation': ''}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': ''}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': ''}, {'ForeName': 'Emmanouil S', 'Initials': 'ES', 'LastName': 'Brilakis', 'Affiliation': ''}, {'ForeName': 'Shuaib M', 'Initials': 'SM', 'LastName': 'Abdullah', 'Affiliation': 'Shuaib Abdullah, MD, Veterans Affairs North Texas Health Care System, 4500 South Lancaster, 111A, Dallas, TX 75216 USA. shuaib.abdullah@utsouthwestern.edu.'}]",The Journal of invasive cardiology,[]
2031,32961529,Randomized COmparison of Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression in Achieving Radial Artery Patency: The OPEN-Radial Trial.,"BACKGROUND
Radial artery occlusion (RAO) occurs after transradial access (TRA), limiting future ipsilateral access. Pragmatic RAO-lowering strategies need to be developed.
METHODS
Patients undergoing transradial cardiac catheterization were randomized to receive postprocedural hemostasis with either a single-bladder radial compression band (group 1) or a double-balloon band capable of simultaneous ipsilateral ulnar artery compression (group 2). Hemostatic compression was performed for 120 minutes. Patients in group 2 received ipsilateral ulnar artery compression for the first 60 minutes of radial hemostasis. The primary endpoint of the study was achievement of patent hemostasis, defined as radial artery patency at 15 minutes after onset of hemostatic compression. Radial artery patency was measured at 15 minutes, 60 minutes, 90 minutes, and 120 minutes after onset of compression and 1 hour after removal of the compression bands.
RESULTS
A total of 253 patients were randomized (127 in group 1 and 126 in group 2). Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001). RAO at 1 hour post band removal was significantly lower in group 2 vs group 1 (1.6% vs 10.2%, respectively; P<.001). Rebound bleeding occurred less frequently in group 2 vs group 1 (1.6% vs 7.9%, respectively; P=.03).
CONCLUSION
Ipsilateral ulnar compression performed for the initial 1 hour during the radial hemostatic process after TRA using a dedicated double-balloon device is associated with higher rates of patent hemostasis and lower incidence of RAO compared with a single-balloon band.",2020,"Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001).","['Patients undergoing transradial cardiac catheterization', '253 patients']","['ipsilateral ulnar artery compression', 'postprocedural hemostasis with either a single-bladder radial compression band (group 1) or a double-balloon band capable of simultaneous ipsilateral ulnar artery compression', 'Isolated Radial Artery ComPrEssioN Versus Radial and Ipsilateral Ulnar Artery Compression']","['Radial artery patency', 'Patent hemostasis', 'Rebound bleeding', 'achievement of patent hemostasis, defined as radial artery patency', 'Hemostatic compression', 'RAO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0162858', 'cui_str': 'Structure of ulnar artery'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",253.0,0.215156,"Patent hemostasis was achieved significantly more frequently in group 2 vs group 1 (96.8% vs 74.8%, respectively; P<.001).","[{'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Bhavin A', 'Initials': 'BA', 'LastName': 'Patel', 'Affiliation': ''}, {'ForeName': 'Tejas M', 'Initials': 'TM', 'LastName': 'Patel', 'Affiliation': 'Apex Heart Institute, Ahmedabad, India. tejaspatel@apexheart.in.'}]",The Journal of invasive cardiology,[]
2032,32963103,Neural effects of oxytocin and mimicry in frontotemporal dementia: A randomized crossover study.,"OBJECTIVE
To determine whether intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions, would augment neural activity in patients with frontotemporal dementia (FTD) in brain regions associated with empathy, emotion processing, and the simulation network, as indexed by blood oxygen-level dependent (BOLD) signal during fMRI.
METHODS
In a placebo-controlled, randomized crossover design, 28 patients with FTD received 72 IU intranasal oxytocin or placebo and then completed an fMRI facial expression mimicry task.
RESULTS
Oxytocin alone and in combination with instructed mimicry increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
CONCLUSIONS
The findings demonstrate latent capacity to augment neural activity in affected limbic and other frontal and temporal regions during social cognition in patients with FTD, and support the promise and need for further investigation of these interventions as therapeutics in FTD.
CLINICALTRIALSGOV IDENTIFIER
NCT01937013.
CLASSIFICATION OF EVIDENCE
This study provides Class III evidence that a single dose of 72 IU intranasal oxytocin augments BOLD signal in patients with FTD during viewing of emotional facial expressions.",2020,"RESULTS
Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","['patients with FTD', 'frontotemporal dementia', 'patients with FTD in brain regions associated with empathy, emotion processing and the simulation network, as indexed by blood-oxygen-level dependent (BOLD) signal during functional magnetic resonance imaging (fMRI', 'patients with FTD during viewing of emotional facial expressions', '28 patients with FTD received 72 IU of']","['intranasal oxytocin, alone or in combination with instructed mimicry of facial expressions', 'oxytocin', 'placebo', 'Oxytocin', 'intranasal oxytocin or placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0236642', 'cui_str': ""Pick's disease""}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0233577', 'cui_str': 'Mimicry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],28.0,0.3629,"RESULTS
Oxytocin alone, and in combination with instructed mimicry, increased activity in regions of the simulation network and in limbic regions associated with emotional expression processing.
","[{'ForeName': 'Lindsay D', 'Initials': 'LD', 'LastName': 'Oliver', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Stewart', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Kryklywy', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bartha', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Derek G V', 'Initials': 'DGV', 'LastName': 'Mitchell', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Finger', 'Affiliation': 'From the Graduate Program in Neuroscience (L.D.O., C.S., J.H.K.) and Department of Clinical Neurological Sciences (E.C.F.), Schulich School of Medicine and Dentistry, Robarts Research Institute (R.B., E.C.F.), and Brain and Mind Institute (D.G.V.M.), Department of Psychiatry and Department of Anatomy and Cell Biology, Western University, London; Campbell Family Mental Health Research Institute (L.D.O.), Centre for Addiction and Mental Health, Toronto; Parkwood Institute Research (K.C., E.C.F.), London, Ontario; and Department of Psychology (J.H.K.), University of British Columbia, Vancouver, Canada. Elizabeth.Finger@lhsc.on.ca.'}]",Neurology,['10.1212/WNL.0000000000010933']
2033,32970315,"Bioequivalence Study Comparing Fixed-Dose Combination of Clopidogrel and Aspirin with Coadministration of Individual Formulations in Chinese Subjects Under Fed Conditions: A Phase I, Open-Label, Randomized, Crossover Study.","INTRODUCTION
Simultaneous administration of acetylsalicylic acid (ASA) and clopidogrel has demonstrated efficacy in the treatment of acute coronary syndrome. Clopidogrel + ASA in a fixed-dose combination (FDC) provides a pharmaceutical option to enhance adherence to the coadministration of dual antiplatelet therapy (DAPT). Herein, we evaluate the bioequivalence of enteric ASA and clopidogrel in an FDC compared with simultaneous administration of the individual formulations.
METHODS
This study is a randomized, single-center, open-label, three-sequence, three-period, two-treatment, crossover study conducted in healthy Chinese male and female subjects under fed conditions. Subjects were randomized to receive, in each period, a single dose of (1) a combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions. Plasma samples were analyzed for ASA, salicylic acid, clopidogrel, and the clopidogrel metabolite SR26334. For ASA, the reference-scaled average bioequivalence (RSABE) analysis was conducted for C max of ASA because within-subject standard deviation (SD W ) was ≥ 0.294 for log-transformed C max .
RESULTS
The point estimate (test/reference geometric mean ratio) was between 0.80 and 1.25, and the upper one-sided 95% confidence interval (CI) for the scaled average bioequivalence metric was ≤ 0 (-0.08). AUC of ASA as SD W was < 0.294 for log-transformed AUC last and AUC. Estimates of 90% CIs for log-transformed AUC last and AUC ratios were within the bioequivalence range of 0.80 to 1.25 (0.98-1.08 and 1.00-1.10, respectively). For clopidogrel, the 90% CIs for the ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel following administration of test versus reference formulation were calculated using the ABE method and were well within the acceptable range of 0.80 to 1.25 (1.02-1.12, 0.92-0.99, and 0.92-0.98, respectively).
CONCLUSION
FDC of ASA and clopidogrel was bioequivalent to the simultaneous administration of the individual formulations in healthy Chinese subjects under fed conditions.
TRIAL REGISTRATION
CTR20190376.",2020,AUC of ASA as SD W was < 0.294 for log-transformed AUC,"['healthy Chinese subjects under fed conditions', 'acute coronary syndrome', 'healthy Chinese male and female subjects under fed conditions', 'Chinese Subjects Under Fed Conditions']","['Clopidogrel and Aspirin with Coadministration of Individual Formulations', 'combination tablet containing 75-mg clopidogrel and 100-mg enteric ASA (test formulation) or (2) coadministration of one 75-mg clopidogrel tablet and one 100-mg enteric-coated ASA tablet (reference formulations) under fed conditions', 'clopidogrel', 'Clopidogrel\u2009+\u2009ASA', 'AUC', 'acetylsalicylic acid (ASA) and clopidogrel']","['AUC ratios', 'ratios comparing log-transformed C max , AUC last , and AUC ratios of clopidogrel']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1248670', 'cui_str': 'clopidogrel Oral Tablet'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]",,0.234126,AUC of ASA as SD W was < 0.294 for log-transformed AUC,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Jeffrey E', 'Initials': 'JE', 'LastName': 'Ming', 'Affiliation': 'Research and Development, Sanofi, New York, USA.'}, {'ForeName': 'Fangyuan', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Huiqiu', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Medical, Sanofi, Beijing, China.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Medical, Sanofi, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ping', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Research and Development, Sanofi, Beijing, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Ju', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China.'}, {'ForeName': 'Xinghe', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China. wangxh@bjsjth.cn.'}]",Advances in therapy,['10.1007/s12325-020-01486-9']
2034,32971005,"Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial.","BACKGROUND
Survival outcomes are poor for patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy. We assessed the overall survival of patients who received durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor), as a first-line treatment for metastatic urothelial carcinoma.
METHODS
DANUBE is an open-label, randomised, controlled, phase 3 trial in patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1. We randomly assigned patients (1:1:1) to receive durvalumab monotherapy (1500 mg) administered intravenously every 4 weeks; durvalumab (1500 mg) plus tremelimumab (75 mg) administered intravenously every 4 weeks for up to four doses, followed by durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility) administered intravenously for up to six cycles. Randomisation was done through an interactive voice-web response system, with stratification by cisplatin eligibility, PD-L1 status, and presence or absence of liver metastases, lung metastases, or both. The coprimary endpoints were overall survival compared between the durvalumab monotherapy versus chemotherapy groups in the population of patients with high PD-L1 expression (the high PD-L1 population) and between the durvalumab plus tremelimumab versus chemotherapy groups in the intention-to-treat population (all randomly assigned patients). The study has completed enrolment and the final analysis of overall survival is reported. The trial is registered with ClinicalTrials.gov, NCT02516241, and the EU Clinical Trials Register, EudraCT number 2015-001633-24.
FINDINGS
Between Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive durvalumab (n=346), durvalumab plus tremelimumab (n=342), or chemotherapy (n=344). At data cutoff (Jan 27, 2020), median follow-up for survival was 41·2 months (IQR 37·9-43·2) for all patients. In the high PD-L1 population, median overall survival was 14·4 months (95% CI 10·4-17·3) in the durvalumab monotherapy group (n=209) versus 12·1 months (10·4-15·0) in the chemotherapy group (n=207; hazard ratio 0·89, 95% CI 0·71-1·11; p=0·30). In the intention-to-treat population, median overall survival was 15·1 months (13·1-18·0) in the durvalumab plus tremelimumab group versus 12·1 months (10·9-14·0) in the chemotherapy group (0·85, 95% CI 0·72-1·02; p=0·075). In the safety population, grade 3 or 4 treatment-related adverse events occurred in 47 (14%) of 345 patients in the durvalumab group, 93 (27%) of 340 patients in the durvalumab plus tremelimumab group, and in 188 (60%) of 313 patients in the chemotherapy group. The most common grade 3 or 4 treatment-related adverse event was increased lipase in the durvalumab group (seven [2%] of 345 patients) and in the durvalumab plus tremelimumab group (16 [5%] of 340 patients), and neutropenia in the chemotherapy group (66 [21%] of 313 patients). Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group. Deaths due to study drug toxicity were reported in two (1%) patients in the durvalumab group (acute hepatic failure and hepatitis), two (1%) patients in the durvalumab plus tremelimumab group (septic shock and pneumonitis), and one (<1%) patient in the chemotherapy group (acute kidney injury).
INTERPRETATION
This study did not meet either of its coprimary endpoints. Further research to identify the patients with previously untreated metastatic urothelial carcinoma who benefit from treatment with immune checkpoint inhibitors, either alone or in combination regimens, is warranted.
FUNDING
AstraZeneca.",2020,"Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group.","['EudraCT number 2015-001633-24.\nFINDINGS\n\n\nBetween Nov 24, 2015, and March 21, 2017, we randomly assigned 1032 patients to receive', 'previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE', 'patients with metastatic urothelial carcinoma who receive standard, first-line, platinum-based chemotherapy', 'patients with previously untreated metastatic urothelial carcinoma', 'Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status of 0 or 1', 'patients with untreated, unresectable, locally advanced or metastatic urothelial carcinoma, conducted at 224 academic research centres, hospitals, and oncology clinics in 23 countries']","['durvalumab (1500 mg) plus tremelimumab', 'durvalumab', 'durvalumab maintenance (1500 mg) every 4 weeks; or standard-of-care chemotherapy (gemcitabine plus cisplatin or gemcitabine plus carboplatin, depending on cisplatin eligibility', 'durvalumab monotherapy', 'durvalumab (a PD-L1 inhibitor), with or without tremelimumab (a CTLA-4 inhibitor', 'Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy', 'durvalumab plus tremelimumab (n=342), or chemotherapy']","['adverse events', 'median overall survival', 'neutropenia', 'median follow-up for survival', 'overall survival', 'adverse event']","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1032.0,0.25074,"Serious treatment-related adverse events occurred in 30 (9%) of 345 patients in the durvalumab group, 78 (23%) of 340 patients in the durvalumab plus tremelimumab group, and 50 (16%) of 313 patients in the chemotherapy group.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, UK. Electronic address: thomas.powles1@nhs.net.'}, {'ForeName': 'Michiel S', 'Initials': 'MS', 'LastName': 'van der Heijden', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Galsky', 'Affiliation': 'The Tisch Cancer Institute, Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Institut Gustave Roussy, INSERM U981, University of Paris Saclay, Villejuif, France.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': 'Smilow Cancer Center, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ogawa', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University Samsung Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jae-Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'De Giorgi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, IRCCS, Meldola, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bögemann', 'Affiliation': 'Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': 'Alexandra Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Eigl', 'Affiliation': 'BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Clinical Medicine, Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Som D', 'Initials': 'SD', 'LastName': 'Mukherjee', 'Affiliation': 'Juravinski Cancer Centre, Hamilton Health Sciences and McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Fradet', 'Affiliation': 'Centre Hospitalier Universitaire de Québec-Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Skoneczna', 'Affiliation': ""Saint Elizabeth's Hospital, Mokotów Medical Center, Warsaw, Poland.""}, {'ForeName': 'Marinos', 'Initials': 'M', 'LastName': 'Tsiatas', 'Affiliation': 'Department of Medical Oncology, Athens Medical Center, Marousi, Greece.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Novikov', 'Affiliation': 'North-Western State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suárez', 'Affiliation': ""Medical Oncology, Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.""}, {'ForeName': 'André P', 'Initials': 'AP', 'LastName': 'Fay', 'Affiliation': 'Hospital Sao Lucas da PUCRS/Grupo Oncoclinicas, Porto Alegre, Brazil.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Duran', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wildsmith', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'He', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Angra', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Ashok K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Levin', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Beth Israel Deaconess Medical Center and PSMAR-IMIM Research Lab, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30541-6']
2035,32985080,"Predictors of receiving a diagnosis, referral and treatment of depression in people on antiretroviral therapy in South African primary care: a secondary analysis of data from a randomised trial.","OBJECTIVE
To describe the receipt of a diagnosis, referral and treatment for depression in people receiving antiretroviral therapy (ART), with depressive symptoms and attending primary care clinics in South Africa, and investigate factors associated with receiving these components of care.
METHODS
This is a secondary analysis of data from a randomised controlled trial of an intervention intended to improve detection and treatment of depression in primary care patients receiving ART. In this analysis, we combined cross-sectional and longitudinal data from the intervention and control arms. Using regression models and adjusting for intra-cluster correlation of outcomes, we investigated associations between socioeconomic characteristics, depressive symptoms, stress, disability and stigma, and receipt of a diagnosis, referral and treatment for depression.
RESULTS
Of 2002 participants enrolled, 18% reported a previous diagnosis of depression by a healthcare worker and 10% reported having received counselling from a specialist mental health worker. Diagnosis, referral and counselling during the follow-up period were appropriately targeted, being independently more frequent in participants with higher enrolment scores for depressive symptoms, stress or disability. Participants with higher stigma scores at enrolment were independently less likely to receive counselling. Severe socio-economic deprivation was common but was not associated with treatment.
CONCLUSION
While the receipt of a diagnosis, referral and treatment for depression were uncommon, they seemed to be appropriately targeted. Socio-economic deprivation was not associated with treatment.",2020,Participants with higher stigma scores at enrolment were independently less likely to receive counselling.,"['people on antiretroviral therapy in South African primary care', '2002 participants enrolled, 18% reported a previous diagnosis of depression by a healthcare worker and 10% reported having received counselling from a specialist mental health worker', 'people receiving antiretroviral therapy (ART), with depressive symptoms and attending primary care clinics in South Africa', 'primary care patients receiving ART']",[],"['sociodemographic characteristics, depressive symptoms, stress, disability, and stigma, and receipt of a diagnosis, referral and treatment for depression', 'Socioeconomic deprivation', 'depressive symptoms, stress or disability', 'Severe socioeconomic deprivation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332132', 'cui_str': 'Prior diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",2002.0,0.292692,Participants with higher stigma scores at enrolment were independently less likely to receive counselling.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zani', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Fairall', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Folb', 'Affiliation': 'Knowledge Translation Unit, University of Cape Town Lung Institute, Cape Town, South Africa.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Centre for Rural Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""Centre for Global Mental Health, King's College London, London, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hanass-Hancock', 'Affiliation': 'HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, King's College London, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bachmann', 'Affiliation': 'Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Tropical medicine & international health : TM & IH,['10.1111/tmi.13495']
2036,32980772,High-frequency repetitive transcranial magnetic stimulation over the primary motor cortex relieves musculoskeletal pain in patients with Parkinson's disease: A randomized controlled trial.,"BACKGROUND
Pain is common in Parkinson's disease, and there is no effective treatment. We conducted a clinical trial to determine whether high-frequency repetitive transcranial magnetic stimulation over the primary motor cortex alleviates musculoskeletal pain in patients with Parkinson's disease.
METHODS
In this single-center and double-blind trial, 52 patients with Parkinson's disease and musculoskeletal pain were randomly allocated to 26-member groups receiving 5 sessions of either 20-Hz repetitive transcranial magnetic stimulation or sham stimulation over the primary motor cortex. The participants underwent assessments in the ""ON"" medication state at baseline, after the fifth session, and at 2- and 4-week follow-up timepoints. The primary outcomes were pain scores on a numeric rating scale. The secondary outcomes were scores on clinical scales assessing motor symptoms, depression, anxiety, autonomic symptoms, sleep quality, and the overall severity of Parkinson's disease.
RESULTS
Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001). Post hoc analyses confirmed that the repetitive transcranial magnetic stimulation group, but not the sham stimulation group, exhibited significant improvements in numeric rating scale pain scores, motor symptom scores, depression scores, anxiety scores, and overall disease severity scores.
CONCLUSION
High-frequency repetitive transcranial magnetic stimulation over the primary motor cortex may be an effective adjunct therapy for alleviating musculoskeletal pain in patients with Parkinson's disease.",2020,"RESULTS
Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001).","[""patients with Parkinson's disease"", ""52 patients with Parkinson's disease and musculoskeletal pain""]","['repetitive transcranial magnetic stimulation', 'high-frequency repetitive transcranial magnetic stimulation', '20-Hz repetitive transcranial magnetic stimulation or sham stimulation over the primary motor cortex', 'High-frequency repetitive transcranial magnetic stimulation']","[""scores on clinical scales assessing motor symptoms, depression, anxiety, autonomic symptoms, sleep quality, and the overall severity of Parkinson's disease"", 'musculoskeletal pain', 'numeric rating scale pain scores, motor symptom scores, depression scores, anxiety scores, and overall disease severity scores', 'numeric rating scale pain scores', 'anxiety scores', 'pain scores on a numeric rating scale', 'depression scores', 'overall disease severity scores', 'motor symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",52.0,0.451476,"RESULTS
Analyses revealed significant group × time interactions for numeric rating scale pain scores (p < 0.001), motor symptom scores (p < 0.001), depression scores (p = 0.009), anxiety scores (p = 0.013), and overall disease severity scores (p < 0.001).","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Department of Neurology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, China.'}, {'ForeName': 'Tao-Mian', 'Initials': 'TM', 'LastName': 'Mi', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Ben-Fan', 'Initials': 'BF', 'LastName': 'Zhu', 'Affiliation': 'Department of Pain, The First Affiliated Hospital of Anhui Medical University, Hefei, China.'}, {'ForeName': 'Jing-Hong', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China.""}, {'ForeName': 'Wen-Ming', 'Initials': 'WM', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, China. Electronic address: yangwm8810@126.com.'}, {'ForeName': 'Piu', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': ""Department of Neurobiology, Neurology and Geriatrics, Xuanwu Hospital of Capital Medical University, Beijing Institute of Geriatrics, Beijing, China; Clinical and Research Center for Parkinson's Disease; Key Laboratory for Neurodegenerative Disease of the Ministry of Education, Beijing Key Laboratory for Parkinson's Disease, Parkinson Disease Center of Beijing Institute for Brain Disorders, Beijing, China; National Clinical Research Center for Geriatric Disorders, Beijing, China; Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China. Electronic address: pbchan@hotmail.com.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.07.006']
2037,32956682,"A feasibility study of application and potential effects of a single session transcranial direct current stimulation (tDCS) on competitive anxiety, mood state, salivary levels of cortisol and alpha amylase in elite athletes under a real-world competition.","OBJECTIVE
To examine feasibility and potential effects of a single session tDCS over the dorsolateral prefrontal cortex (DLPFC) on competitive anxiety, mood state, and autonomic and endocrine stress responses in elite archer athletes under a real world competition.
METHODS
Twelve male elite archers volunteered to participate in this pilot trial. Participants were randomized in order to take left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System) in a within-subject study design. This study included three official competitions. About 45 min before the competition, the tDCS stimulation process was started and the participants were stimulated for 20 min with 2 mA current. Psychophysiological responses, including Brunel Mood Scale and Competitive state anxiety inventory-2-revied, were collected 15 min before each competition. Additionally, salivary cortisol (sCort) and salivary alpha-amylase (sAA) were collected 1 hour and 10 min before competition as well as 10 min and 1 hour after competition.
RESULTS
Findings demonstrated that anodal tDCS was feasible and could lead to enhance mood state (vigor, tension and fatigue) and a decrease in competitive anxiety, as compared to cathodal and sham stimulation (all p < 0.05). However, self-confidence remained unaffected by the tDCS (p > 0.05). Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05). Correlations between competitive anxiety and mood states with physiological stress markers (sCort and sAA) were not significant (all p > 0.05).
CONCLUSIONS
The present study provides the first preliminary evidence that anodal tDCS over the DLPFC is feasible and could modulate competitive anxiety and physiological stress responses to the acute stress of competition (potentially by a top-down regulation of HPA and SAM systems as well as the vagal system). Findings support the notion that non-invasive brain stimulation might be advantageous to enhance sport performance under competitive situations. However, additional studies in a larger sample size and different sport activities are encouraged to substantiate the findings.",2020,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"['elite athletes under a real-world competition', 'elite archer athletes under a real world competition', 'Twelve male elite archers volunteered to participate in this pilot trial']","['anodal tDCS', 'single session transcranial Direct Current Stimulation (tDCS', 'left anodal DLPFC, left cathodal DLPFC, or sham stimulation (the F3 or F4 areas according to the 10/20 EEG International System', 'single session tDCS']","['lower salivary cortisol and alpha-amylase response', 'competitive anxiety and mood states with physiological stress markers (sCort and sAA', 'competitive anxiety, mood state, salivary levels of cortisol and alpha amylase', 'competitive anxiety', 'competitive anxiety, mood state, and autonomic and endocrine stress responses', 'Psychophysiological responses, including Brunel Mood Scale and Competitive State Anxiety inventory-2-Revied', 'salivary cortisol (sCort) and salivary alpha-amylase (sAA', 'enhance mood state (vigor, tension and fatigue']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350322', 'cui_str': 'Salivary alpha-Amylases'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",12.0,0.0310646,Anodal stimulation resulted in a lower salivary cortisol and alpha-amylase response (all p < 0.05).,"[{'ForeName': 'Amir Hossien', 'Initials': 'AH', 'LastName': 'Mehrsafar', 'Affiliation': 'Department of Sport Psychology, Faculty of Sport Sciences, University of Tehran, Tehran, Iran. Electronic address: a.mehrsafar@ut.ac.ir.'}, {'ForeName': 'Miguel Angel Serrano', 'Initials': 'MAS', 'LastName': 'Rosa', 'Affiliation': 'Department of Psychobiology, Faculty of Psychology, University of Valencia, Valencia, Spain; Laboratory of Cognitive and Affective Neuroscience, Faculty of psychology, University of Valencia, Valencia, Spain. Electronic address: m.angel.serrano@uv.es.'}, {'ForeName': 'Ali Moghadam', 'Initials': 'AM', 'LastName': 'Zadeh', 'Affiliation': 'Department of Psychology, Faculty of Psychology and Education, University of Tehran, Tehran, Iran. Electronic address: amoghadamzadeh@ut.ac.ir.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg E, Denmark. Electronic address: gazerani@hst.aau.dk.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113173']
2038,32958583,Proof of Concept of a Personalized Genetic Risk Tool to Promote Smoking Cessation: High Acceptability and Reduced Cigarette Smoking.,"Relatively little is known about the possible effects of personalized genetic risk information on smoking, the leading preventable cause of morbidity and mortality. We examined the acceptability and potential behavior change associated with a personalized genetically informed risk tool ( RiskProfile ) among current smokers. Current smokers ( n = 108) were enrolled in a pre-post study with three visits. At visit 1, participants completed a baseline assessment and genetic testing via 23andMe. Participants' raw genetic data ( CHRNA5 variants) and smoking heaviness were used to create a tailored RiskProfile tool that communicated personalized risks of smoking-related diseases and evidence-based recommendations to promote cessation. Participants received their personalized RiskProfile intervention at visit 2, approximately 6 weeks later. Visit 3 involved a telephone-based follow-up assessment 30 days after intervention. Of enrolled participants, 83% were retained across the three visits. Immediately following intervention, acceptability of RiskProfile was high (M = 4.4; SD = 0.6 on scale of 1 to 5); at 30-day follow-up, 89% of participants demonstrated accurate recall of key intervention messages. In the full analysis set of this single-arm trial, cigarettes smoked per day decreased from intervention to 30-day follow-up [11.3 vs. 9.8; difference = 1.5; 95% confidence interval (0.6-2.4); P = 0.001]. A personalized genetically informed risk tool was found to be highly acceptable and associated with a reduction in smoking, although the absence of a control group must be addressed in future research. This study demonstrates proof of concept for translating key basic science findings into a genetically informed risk tool that was used to promote progress toward smoking cessation. PREVENTION RELEVANCE: This study demonstrates that personal genetic information can be incorporated into a risk feedback tool that was highly acceptable to current smokers and associated with reductions in smoking. These findings may pave the way for effectiveness and implementation research on genetically-informed behavior change interventions to enhance cancer prevention efforts.",2020,"Immediately following intervention, acceptability of RiskProfile was high (M=4.4; SD=0.6 on scale of 1 to 5); at 30-day follow-up, 89% of participants demonstrated accurate recall of key intervention messages.","[""Participants' raw genetic data (CHRNA5 variants) and smoking heaviness"", 'Current smokers (n=108) were enrolled in a pre-post study with three visits', 'current smokers']","['personalized genetically-informed risk tool (RiskProfile', 'personalized RiskProfile intervention']","['acceptability and potential behavior change', 'acceptability of RiskProfile']","[{'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}]",108.0,0.0315177,"Immediately following intervention, acceptability of RiskProfile was high (M=4.4; SD=0.6 on scale of 1 to 5); at 30-day follow-up, 89% of participants demonstrated accurate recall of key intervention messages.","[{'ForeName': 'Alex T', 'Initials': 'AT', 'LastName': 'Ramsey', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri. aramsey@wustl.edu.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Bourdon', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Dorsey', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Zalik', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Pietka', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Salyer', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'School of Psychological Science, University of Bristol, Bristol, England, United Kingdom.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, Missouri.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0328']
2039,32959458,Hypersensitivity to Calcitonin Gene-Related Peptide in Post-Traumatic Headache.,"OBJECTIVE
To demonstrate that calcitonin gene-related peptide (CGRP) induces headache exacerbation with migraine-like features in patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI).
METHODS
A randomized, double-blind, placebo-controlled, two-way crossover study was conducted. Analyses were intention-to-treat. Eligible patients were aged 18 to 65 years and had a history of persistent PTH after mild TBI for at least 12 months. Patients were randomized to receive an intravenous infusion of 1.5μg/min of CGRP or placebo (isotonic saline) over 20 minutes on two separate experimental days. A 12-hour observational period was used to evaluate the following outcomes: (1) difference in incidence of headache exacerbation with migraine-like features and (2) difference in area under the curve for headache intensity scores.
RESULTS
Thirty patients (mean age = 37 years, 25 women [83%]) were randomized and completed the study. During the 12-hour observational period, 21 of 30 patients (70%) developed headache exacerbation with migraine-like features after CGRP, compared with 6 patients (20%) after placebo (p < 0.001). The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (p < 0.001).
INTERPRETATION
Patients with persistent PTH are hypersensitive to CGRP, which underscores its pathophysiological importance. Furthermore, CGRP-targeted therapies might provide a novel mechanism-based treatment option for patients with persistent PTH. ANN NEUROL 2020;88:1220-1228.",2020,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","['Thirty patients (mean age, 37\u2009years; 25 women [83', 'Eligible patients were aged 18 to 65\u2009years and had a history of persistent PTH after mild TBI for at least 12\u2009months', 'patients with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (TBI', 'patients with persistent PTH']","['placebo', 'Calcitonin Gene-Related Peptide', 'calcitonin gene-related peptide (CGRP', 'intravenous infusion 1.5\u2009μg/min of CGRP or placebo (isotonic saline']","['headache intensity scores', 'headache exacerbation with migraine-like features, 2) difference in area under the curve for headache intensity scores', 'headache exacerbation with migraine-like features']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0032816', 'cui_str': 'Posttraumatic headache'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.678888,"The baseline-corrected area under the curve for headache intensity scores was significantly larger after CGRP, compared with placebo (P < 0.001).
","[{'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Afrim', 'Initials': 'A', 'LastName': 'Iljazi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Haidar M', 'Initials': 'HM', 'LastName': 'Al-Khazali', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Casper E', 'Initials': 'CE', 'LastName': 'Christensen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Faisal M', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik W', 'Initials': 'HW', 'LastName': 'Schytz', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Annals of neurology,['10.1002/ana.25915']
2040,32959761,Waterless Hand Cleansing with Chlorhexidine during the Neonatal Period by Mothers and Other Household Members: Findings from a Randomized Controlled Trial.,"Observational data suggest maternal handwashing with soap prevents neonatal mortality. We tested the impact of a chlorhexidine-based waterless hand cleansing promotion on the behavior of mothers and other household members. In rural Bangladesh in 2014, we randomized consenting pregnant women to chlorhexidine provision and hand cleansing promotion or standard practices. We compared hand cleansing with chlorhexidine or handwashing with soap before baby care, among mothers and household members in the two groups, and measured chlorhexidine use in the intervention arm. Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes. Hand cleansing before baby care was observed 5.6 times more frequently among mothers in the intervention arm than in the controls (95% CI = 4.0-7.7). Hand cleansing was significantly more frequently observed in the intervention arm among women other than the mother (RR = 10.9) and girls (RR = 37.0). Men and boys in the intervention arm cleansed hands before 29% and 44% of baby care events, respectively, compared with 0% in the control arm. The median number of grams consumed during the neonatal period was 176 (IQR = 95-305 g), about 7.8 g/day (IQR = 4.2-13.8 g). Promotion of waterless chlorhexidine increased hand cleansing behavior among mothers and other household members. Discrepancy between observed use and measured chlorhexidine consumption suggested courtesy bias in structured observations. A waterless hand cleanser may represent one component of the multimodal strategies to prevent neonatal infections in low-resource settings.",2020,"Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes.","['Mothers and Other Household Members', 'mothers and other household members', ""baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes""]","['chlorhexidine', 'Chlorhexidine', 'chlorhexidine provision and hand cleansing promotion or standard practices', 'chlorhexidine-based waterless hand cleansing promotion']","['hand cleansing behavior', 'median number of grams consumed during the neonatal period', 'Hand cleansing', 'neonatal mortality']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",,0.0768261,"Chlorhexidine was observed in the baby's sleep space in 97% of 130 intervention homes, versus soap in 59% of 128 control homes.","[{'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Farzana', 'Initials': 'F', 'LastName': 'Begum', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Crabtree-Ide', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Mohammad Rofi', 'Initials': 'MR', 'LastName': 'Uddin', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Weaver', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Md Golam', 'Initials': 'MG', 'LastName': 'Dostogir Harun', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Jelena V', 'Initials': 'JV', 'LastName': 'Allen', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Swapna', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Sharifa', 'Initials': 'S', 'LastName': 'Nasreen', 'Affiliation': 'State University of New York at Buffalo, Buffalo, New York.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Shams', 'Initials': 'S', 'LastName': 'El Arifeen', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0773']
2041,32965037,Melatonin for Acute Treatment of Migraine in Children and Adolescents: A Pilot Randomized Trial.,"OBJECTIVE
To determine what dose of melatonin is most effective for treating migraine acutely in children and adolescents.
BACKGROUND
Acute migraine medications may not work for all patients and may cause side effects. Melatonin is effective for migraine prevention in adults and has been used acutely for procedural pain in children. Our goal was to determine whether a ""high"" or ""low"" dose of melatonin is more effective for treating migraine acutely in youth.
METHODS
In this pilot, randomized, open-label, single-center, dose-finding trial, children and adolescents aged 4-17 years with episodic migraine were randomized to ""high-dose"" or ""low-dose"" dose melatonin (<40 kg: 4 mg vs. 1 mg; ≥40 kg: 8 mg vs. 2 mg). The primary outcome measure was change in mean pain score between time 0 and 2 hours. Secondary outcomes included 2-hour pain-relief and pain-freedom rates.
RESULTS
Eighty-four participants (n = 42 per group) were enrolled in this study. Mean (SD) participant age was 11.8 (3.5) years and 55% (46/84) were female. Mean (SD) headache days/month was 5.6 (3.8). Sixty-six (79%) participants provided outcome data and were included in the analyses, n = 24 in the high-dose group and n = 22 in the low-dose group. The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group. Mean (SD) change in pain intensity at 2 hours was -2.7 (2.1) cm in the high-dose group vs. -2.3 (2.1) cm in the low-dose group (p = .581), a difference of 0.4 cm (95% CI: -1.17 to 1.92). Two-hour pain-freedom rate was 41% (7/17) vs. 27% (4/15) in the high-dose vs. low-dose groups (p = .415), and 2-hour pain-relief rate was 94% (16/17) vs. 80% (12/15), (p = .482). There were no serious adverse events. Napping occurred in the majority (67% (14/21) high dose vs. 47% (9/19) low dose). Higher mg/kg dose of melatonin and napping were each independently associated with greater headache benefit.
CONCLUSIONS
As an acute treatment for pediatric migraine, both low and high doses of melatonin were associated with pain reduction; however, study drop-out was high. Higher dose and napping after treatment predicted greater benefit.",2020,The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group.,"['n\xa0=\xa042 per group) were enrolled in this study', 'Eighty-four participants ', 'children and adolescents', 'Sixty-six (79%) participants provided outcome data and were included in the analyses, n\xa0', 'Children and Adolescents', 'children and adolescents aged 4-17\xa0years with episodic migraine', 'Mean (SD) participant age was 11.8 (3.5) years and 55% (46/84) were female']","['melatonin', 'high-dose"" or ""low-dose"" dose melatonin', 'Melatonin']","['mean pain score', 'Mean (SD) change in pain intensity', 'headache benefit', 'Mean (SD) headache days/month', '2-hour pain-relief and pain-freedom rates', '2-hour pain-relief rate', 'pain-freedom rate', 'serious adverse events']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319623', 'cui_str': '84'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.322068,The drop-out rate was 43% (18/42) in the high-dose group vs. 48% (20/42) in the low-dose group.,"[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gelfand', 'Affiliation': 'Department of Neurology, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Ross', 'Affiliation': 'Department of Pediatrics, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Irwin', 'Affiliation': 'Department of Neurology, UCSF Child & Adolescent Headache Program, San Francisco, CA, USA.'}, {'ForeName': 'Kaitlin A', 'Initials': 'KA', 'LastName': 'Greene', 'Affiliation': 'Division of Pediatric Neurology, Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Qubty', 'Affiliation': 'Pediatric Headache Program, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'I Elaine', 'Initials': 'IE', 'LastName': 'Allen', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California San Francisco, San Francisco, CA, USA.'}]",Headache,['10.1111/head.13934']
2042,32965655,"PSO-LONG: Design of a Novel, 12-Month Clinical Trial of Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam in Psoriasis.","BACKGROUND
Psoriasis vulgaris is commonly treated with topical corticosteroids and vitamin D analogues. Although potent and super-potent topical corticosteroids are very effective at clearing psoriasis, with short-term reactive treatment durations, symptoms usually recur after treatment discontinuation, necessitating long-term disease management strategies. A foam formulation of calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50 μg/g and betamethasone dipropionate 0.5 mg/g, is approved for the daily treatment of psoriasis for up to 4 weeks. Here, we describe a clinical trial protocol for evaluating the long-term safety and efficacy of twice-weekly Cal/BD foam as a proactive topical maintenance therapy for plaque psoriasis for up to 52 weeks.
OBJECTIVE
The aim of this trial was to evaluate the safety and efficacy of Cal/BD foam when applied twice weekly for up to 52 weeks as proactive maintenance therapy, with the goal of preventing or delaying disease relapse as long as possible while minimizing adverse effects.
METHODS
Once-daily Cal/BD foam treatment responders from an initial 4-week open-label period were randomized to receive Cal/BD foam or foam vehicle applied to previously cleared plaques twice weekly for up to 52 weeks. In case of relapse, affected subjects in either group received rescue therapy with once-daily Cal/BD foam for 4 weeks on active areas. Thus, the trial (NCT02899962) compared the long-term use of Cal/BD foam in a proactive approach with a conventional, reactive approach.
PLANNED OUTCOMES
Efficacy endpoints included the time to first relapse, the number of relapse-free days, and the number of relapses during the maintenance phase. Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT02899962.",2020,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","['plaque psoriasis for up to 52\xa0weeks', 'in Psoriasis']","['Topical, Proactive Maintenance with Twice-Weekly Cal/BD Foam', 'calcipotriol and betamethasone dipropionate (Cal/BD foam), consisting of calcipotriol 50\xa0μg', 'betamethasone dipropionate']","['adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function', 'safety and efficacy', 'time to first relapse, the number of relapse-free days, and the number of relapses']","[{'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0714231,"Safety assessments included adverse events, incidence of rebound, local safety and tolerability scores, and effects on calcium metabolism and hypothalamic-pituitary-adrenal axis function.
","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Department of Dermatology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alonso-Llamazares', 'Affiliation': 'Department of Dermatology, VA Medical Center, Miami, FL, USA.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': 'Department of Dermatology, University Hospital of Nice, Nice, France.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Dermatology Centre, Salford Royal NHS Foundation Trust, NIHR Manchester BRC University of Manchester, Manchester, UK.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Kircik', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA. lebwohl@aol.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Advances in therapy,['10.1007/s12325-020-01497-6']
2043,32961347,Low-dose rituximab lowers serum Exosomal miR-150-5p in AChR-positive refractory myasthenia gravis patients.,"Two potentially related microRNAs (miRNAs; miR-150-5p and miR-146a-5p) were examined after low-dose rituximab (RTX) treatment in patients with acetylcholine receptor antibody (AChR)-positive refractory myasthenia gravis (MG). In this prospective, open-label, and self-controlled pilot trial, 12 AChR-positive refractory MG patients were administrated a single, low dose of RTX and followed up at six months. Results showed that RTX decreased the serum exosomal miR-150-5p, scores on three clinical indices (MGFA, MMT, ADL), and patients' prednisolone requirement. Additionally, CD19+ and CD27+ B cells decreased, showing a strong correlation with miR-150-5p. In conclusion, low-dose RTX is effective for AChR-positive refractory MG treatment. Furthermore, our data support the role of miR-150-5p as a potential biomarker for MG.",2020,"Additionally, CD19+ and CD27+ B cells decreased, showing a strong correlation with miR-150-5p.","['AChR-positive refractory myasthenia gravis patients', '12 AChR-positive refractory MG patients']","['Low-dose rituximab', 'RTX', 'acetylcholine receptor antibody ', 'rituximab (RTX']","['serum exosomal miR-150-5p, scores on three clinical indices (MGFA, MMT, ADL', 'CD19+ and CD27+ B cells']","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C0054949', 'cui_str': 'Lymphocyte antigen CD27'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}]",12.0,0.0396666,"Additionally, CD19+ and CD27+ B cells decreased, showing a strong correlation with miR-150-5p.","[{'ForeName': 'Huahua', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Jing', 'Affiliation': ""Department of Neurology, Jing'an District Centre Hospital of Shanghai, Fudan University, China.""}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China.'}, {'ForeName': 'Sushan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China. Electronic address: luosushan@fudan.edu.cn.'}, {'ForeName': 'Chongbo', 'Initials': 'C', 'LastName': 'Zhao', 'Affiliation': ""Department of Neurology, Huashan Hospital, Shanghai Medical College, Fudan University, China; Department of Neurology, Jing'an District Centre Hospital of Shanghai, Fudan University, China. Electronic address: zhao_chongbo@fudan.edu.cn.""}]",Journal of neuroimmunology,['10.1016/j.jneuroim.2020.577383']
2044,32970234,The impact of Hayward green kiwifruit on dietary protein digestion and protein metabolism.,"PURPOSE
The purpose of the study was to determine if an actinidin protease aids gastric digestion and the protein anabolic response to dietary protein.
METHODS
Hayward green kiwifruit (containing an actinidin protease) and Hort 16A gold kiwifruit (devoid of actinidin protease) were given in conjunction with a beef meal to healthy older subjects. Twelve healthy older males (N = 6) and females (N = 6) were studied with a randomized, double-blinded, crossover design to assess muscle and whole-body protein metabolism before and after ingestion of kiwifruit and 100 g of ground beef. Subjects consumed 2 of each variety of kiwifruit daily for 14 d prior to each metabolic study, and again during each study with beef intake.
RESULTS
Hayward green kiwifruit consumption with beef resulted in a more rapid increase in peripheral plasma essential amino acid concentrations. There were significant time by kiwifruit intake interactions for plasma concentrations of EAAs, branched chain amino acids (BCAAs), and leucine (P < 0.01). However, there was no difference in the total amount of EAAs absorbed. As a result, there were no differences between kiwifruit in any of the measured parameters of protein kinetics.
CONCLUSION
Consumption of Hayward green kiwifruit, with a beef meal facilitates protein digestion and absorption of the constituent amino acids as compared to Hort 16A gold kiwifruit.
CLINICAL TRIAL
NCT04356573, April 21, 2020 ""retrospectively registered"".",2020,"RESULTS
Hayward green kiwifruit consumption with beef resulted in a more rapid increase in peripheral plasma essential amino acid concentrations.","['healthy older subjects', 'Twelve healthy older males (N\u2009=\u20096) and females (N\u2009=\u20096']","['Hayward green kiwifruit (containing an actinidin protease) and Hort 16A gold kiwifruit (devoid of actinidin protease', 'Hayward green kiwifruit']","['peripheral plasma essential amino acid concentrations', 'plasma concentrations of EAAs, branched chain amino acids (BCAAs), and leucine']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0971874', 'cui_str': 'Actinidia deliciosa'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0050639', 'cui_str': 'Actinidin'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}]",12.0,0.0721214,"RESULTS
Hayward green kiwifruit consumption with beef resulted in a more rapid increase in peripheral plasma essential amino acid concentrations.","[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Church', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Carlene', 'Initials': 'C', 'LastName': 'Starck', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Schutzler', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Azhar', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Il-Young', 'Initials': 'IY', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular Medicine, Lee Gil Ya Cancer and Diabetes Institute, College of Medicine, Gachon University, Incheon, Republic of Korea.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Moughan', 'Affiliation': 'Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA. rwolfe2@uams.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02363-5']
2045,32966585,"Nighttime Agitation and Restless Legs Syndrome in Persons With Alzheimer's Disease: Study Protocol for a Double-Blind, Placebo-Controlled, Randomized Trial (NightRest).","Nighttime agitation is a prevalent symptom in persons with Alzheimer's disease (AD). Effective treatments are absent due to our limited knowledge of its etiology. We hypothesized that restless legs syndrome (RLS), a common neurological sensorimotor disorder of uncomfortable leg sensations that appear at night and interfere with sleep, might be a cause for nighttime agitation in persons with AD. RLS is infrequently identified in persons with AD because traditional diagnosis is dependent on patients answering complex questions about their symptoms. With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects. We hypothesize that frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation. This study is an 8-week, double-blind, placebo-controlled, randomized pilot clinical trial, followed by an 8-week open-label trial, that is being conducted in long-term care settings and private homes. The results of this study may shift, personalize, and improve standards of care for treatment of nighttime agitation; reduce aggression and other nighttime agitation behaviors; and improve sleep.
TARGETS
Persons with AD with nighttime agitation potentially caused by RLS.
INTERVENTION DESCRIPTION
Diagnose RLS and determine the effect of GEn.
MECHANISMS OF ACTION
The frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation.
OUTCOMES
Determine the effect of GEn on nighttime agitation, sleep, and antipsychotic medications.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03082755 (Date of registration March 6, 2017). [Research in Gerontological Nursing, 13(6), 280-288.].",2020,"With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects.","[""Persons With Alzheimer's Disease"", 'Persons with AD with nighttime agitation potentially caused by RLS', 'persons with AD', ""persons with Alzheimer's disease (AD""]","['placebo', 'GEn', 'Placebo', 'gabapentin enacarbil (GEn']","['Nighttime Agitation and Restless Legs Syndrome', 'nighttime agitation, sleep, and antipsychotic medications', 'Nighttime agitation', 'nighttime agitation, sleep, antipsychotic medications']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2700226', 'cui_str': 'Gabapentin enacarbil'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.449575,"With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects.","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Richards', 'Affiliation': ''}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': ''}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Rangel', 'Affiliation': ''}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Loera', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Hanlon', 'Affiliation': ''}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Lozano', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kovach', 'Affiliation': ''}, {'ForeName': 'Nalaka', 'Initials': 'N', 'LastName': 'Gooneratne', 'Affiliation': ''}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Fry', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allen', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20200918-01']
2046,32967646,Protocol of a randomized controlled trial to test the effects of client-centered Representative Payee Services on antiretroviral therapy adherence among marginalized people living with HIV.,"BACKGROUND
Client-Centered Representative Payee (CCRP) is an intervention modifying implementation of a current policy of the US Social Security Administration, which appoints organizations to serve as financial payees on behalf of vulnerable individuals receiving Social Security benefits. By ensuring beneficiaries' bills are paid while supporting their self-determination, this structural intervention may mitigate the effects of economic disadvantage to improve housing and financial stability, enabling self-efficacy for health outcomes and improved antiretroviral therapy adherence. This randomized controlled trial will test the impact of CCRP on marginalized people living with HIV (PLWH). We hypothesize that helping participants to pay their rent and other bills on time will improve housing stability and decrease financial stress.
METHODS
PLWH (n = 160) receiving services at community-based organizations will be randomly assigned to the CCRP intervention or the standard of care for 12 months. Fifty additional participants will be enrolled into a non-randomized (""choice"") study allowing participant selection of the CCRP intervention or control. The primary outcome is HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts. Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months. Viral load, CD4, and appointment adherence data will be collected at baseline, 6, 12, 18, and 24 months from medical records. Outcomes will be compared by treatment group in the randomized trial, in the non-randomized cohort, and in the combined cohort. Qualitative data will be collected from study participants, eligible non-participants, and providers to explore underlying mechanisms of adherence, subjective responses to the intervention, and implementation barriers and facilitators.
DISCUSSION
The aim of this study is to determine if CCRP improves health outcomes for vulnerable PLWH. Study outcomes may provide information about supports needed to help economically fragile PLWH improve health outcomes and ultimately improve HIV health disparities. In addition, findings may help to refine service delivery including the provision of representative payee to this often-marginalized population. This protocol was prospectively registered on May 22, 2018 with ClinicalTrials.gov (NCT03561103) .",2020,"Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months.","['Fifty additional participants', 'PLWH (n\u2009', 'marginalized people living with HIV (PLWH', '160) receiving services at community-based organizations', 'marginalized people living with HIV']","['CCRP intervention or control', 'Client-Centered Representative Payee (CCRP', 'CCRP', 'client-centered Representative Payee Services', 'CCRP intervention']","['antiretroviral therapy adherence', 'HIV health disparities', 'ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care', 'Viral load, CD4, and appointment adherence data', 'HIV medication adherence, assessed via the CASE adherence index, viral load, and CD4 counts']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}]","[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",,0.254784,"Self-assessment data for ART adherence, housing instability, self-efficacy for health behaviors, financial stress, and retention in care will be collected at baseline, 3, 6, and 12 months.","[{'ForeName': 'Abisola', 'Initials': 'A', 'LastName': 'Olaniyan', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Creasy', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'Department of Social Work, College of Arts and Sciences, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Maria Mori', 'Initials': 'MM', 'LastName': 'Brooks', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Maulsby', 'Affiliation': 'Department of Health, Behavior and Society, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Musgrove', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hagan', 'Affiliation': 'Action Wellness, Philadelphia, PA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Courtenay', 'Initials': 'C', 'LastName': 'Sashin', 'Affiliation': 'Epidemiology Data Center, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Farmartino', 'Affiliation': 'The Open Door, Inc., Pittsburgh, PA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hawk', 'Affiliation': 'Department of Behavioral and Community Health Sciences, University of Pittsburgh Graduate School of Public Health, 130 De Soto Street, 6120 Public Health, Pittsburgh, PA, 15261, USA. meh96@pitt.edu.'}]",BMC public health,['10.1186/s12889-020-09500-z']
2047,32968936,Effectiveness of Atorvastatin in the Treatment of Asymptomatic Heart Failure After Myocardial Infarction: A Clinical Study.,"INTRODUCTION
Silent heart failure after myocardial infarction has not been effectively treated. Atorvastatin has certain efficacy in the treatment of heart failure. Our clinical study aimed to investigate the effectiveness of atorvastatin in patients with asymptomatic heart failure after myocardial infarction.
METHODS
A total of 162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019 were randomly divided into the observation group (81 cases were treated with atorvastatin on the basis of routine therapy) and the control group (81 cases were treated with routine symptomatic treatment). The clinical curative effect, the level of related inflammatory cytokines, cardiac function index, and vascular endothelial function were compared between the two groups.
RESULTS
Before intervention, there was no significant difference in tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD) between the two groups. After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups. The clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD in the observation group showed significantly greater results than those in the control group (P < 0.05).
CONCLUSION
Atorvastatin exerted a great effect in treating asymptomatic heart failure after myocardial infarction, which can evidently reduce the level of related inflammatory cytokines, improve cardiac function, and regulate vascular endothelial function. Hence, atorvastatin is considered a valid and alternative approach in clinical practice.",2020,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","['Asymptomatic Heart Failure', 'heart failure', 'After Myocardial Infarction', 'patients with asymptomatic heart failure after myocardial infarction', '162 patients with asymptomatic heart failure after myocardial infarction in our hospital from August 2018 to August 2019']","['Atorvastatin', 'atorvastatin']","['clinical curative effect, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'level of related inflammatory cytokines, cardiac function index, and vascular endothelial function', 'TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD', 'tumor necrosis factor (TNFα), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6), plasma N-terminal B-type natriuretic peptide (NT-ProBNP), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVESD), left ventricular posterior wall thickness (LVPWT), asymmetric dimethyarginine (ADMA), activity of nitric oxide synthase (NOS), nitric oxide (NO) and flow-mediated dilation (FMD']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0067385', 'cui_str': 'N,N-dimethylarginine'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",162.0,0.0159963,"After intervention, TNFα, hs-CRP, IL-6, NT-ProBNP, LVEF, LVEDD, LVESD, LVPWT, ADMA, NOS, NO, and FMD were improved in both groups.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Bai', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Cui', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Yang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. 13933058601@163.com.'}, {'ForeName': 'Ji-Dong', 'Initials': 'JD', 'LastName': 'Zhang', 'Affiliation': 'The Sixth Department of Cardiovascular Medicine, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}]",Advances in therapy,['10.1007/s12325-020-01441-8']
2048,32975829,Portable gluten sensors: qualitative assessments by adults and adolescents with coeliac disease.,"BACKGROUND
Portable gluten sensors are now commercially available to the public, although there is genuine uncertainty within the medical community over whether they should be used for coeliac disease management. The present study described qualitatively the experience of using a portable gluten sensor for 15 adults and 15 adolescents with coeliac disease participating in a 3-month pilot clinical trial.
METHODS
Participants were 30 individuals, aged 13-70 years, with biopsy-confirmed coeliac disease on a gluten-free diet. All received a portable gluten sensor and were randomised to low, medium, and high numbers of single-use capsules. Open-ended questions addressed likes and dislikes using the portable gluten sensor after 3 months. Major themes were identified and described.
RESULTS
Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind. Participants disliked having attention drawn to them when using the sensor and feeling as if they were deterring others from eating. Participants also disliked the physical difficulty associated with using the capsules, questionable accuracy and the inability to test fermented foods. Adults were more enthusiastic about the sensor than adolescents.
CONCLUSIONS
Positive and negative experiences may be expected when using commercially available portable gluten sensors to help manage coeliac disease. As future versions of this and other gluten sensors become available, it will be important to investigate the relationship between users' experience with the sensors and long-term outcomes such as mucosal healing and quality of life.",2020,"RESULTS
Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind.","['15 adults and 15 adolescents with coeliac disease participating in a 3-month pilot clinical trial', 'adults and adolescents with coeliac disease', 'Participants were 30 individuals, aged 13-70\xa0years, with biopsy-confirmed coeliac disease on a gluten-free diet']",['portable gluten sensor'],['mucosal healing and quality of life'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007570', 'cui_str': 'Celiac disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0344351', 'cui_str': 'Gluten free diet'}]","[{'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",15.0,0.0266346,"RESULTS
Participants liked that the portable gluten sensor provided extra assurance to check foods presented as gluten-free, the convenient size and portability, the added sense of control, and overall peace-of-mind.","[{'ForeName': 'R L', 'Initials': 'RL', 'LastName': 'Wolf', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vipperman-Cohen', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'P H R', 'Initials': 'PHR', 'LastName': 'Green', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Reilly', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zybert', 'Affiliation': 'Department of Health & Behavior Studies, Program in Nutrition, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Medicine, Celiac Disease Center, Columbia University Irving Medical Center, Harkness Pavilion, New York, NY, USA.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12810']
2049,32979620,"Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial.","BACKGROUND
Although massive bleeding following transbronchial lung biopsies (TBLB) is rare, even minor hemorrhage may prolong the procedure and result in inadequate sampling. Tranexamic acid (TXA) is an antifibrinolytic agent, which reduces bleeding in numerous scenarios, however, its prophylactic use in mitigating post-TBLB bleeding has not been investigated. We conducted a prospective, randomized, double-blind, placebo-controlled trial to determine whether topical infusion of TXA prior to TBLB would reduce bleeding, shorten procedure duration and increase the number of biopsies obtained.
METHODS
We blindly randomized patients undergoing TBLB to receive topical TXA or placebo in the lobar bronchus prior to biopsies. Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained were measured. Data was analyzed using the two-tailed Student's T-Test, Chi-square or Mann-Whitney tests as appropriate.
RESULTS
Fifty patients were randomized, 26 to the TXA arm. The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90). There were no clinically significant adverse events in any of the groups up to one month of follow up.
CONCLUSION
Endobronchial installation of TXA prior to obtaining TBLB results in less bleeding and allows more biopsies to be obtained with no additional adverse events. The prophylactic use of TXA during TBLB may be considered as standard.",2020,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","['We blindly randomized patients undergoing TBLB to receive', 'Fifty patients were randomized, 26 to the TXA arm']","['Tranexamic acid (TXA', 'topical TXA or placebo', 'tranexamic acid', 'placebo', 'TXA']","['number of biopsies obtained', 'adverse events', 'procedure length', ""Vital signs, procedure length, fluid balance (as a measure of the amount of bleeding), operator's assessment of bleeding, and number of biopsies obtained"", 'bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0863477', 'cui_str': 'Transbronchial lung biopsy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449807', 'cui_str': 'Number of biopsies'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.616386,"The bleeding in the TXA group was significantly lower (P = 0.0037), with more specimens being obtained (placebo 7 (6, 9) (median and interquartile range) vs. TXA 9 (8, 10), P = 0.023) and no difference in procedure length (placebo 30 min (29.3, 34.3) vs. TXA 30 (24.8, 36), P = 0.90).","[{'ForeName': 'Rottem', 'Initials': 'R', 'LastName': 'Kuint', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel. Electronic address: kuint@hadassah.org.il.'}, {'ForeName': 'Liran', 'Initials': 'L', 'LastName': 'Levy', 'Affiliation': 'Institute of Pulmonary Medicine, Chaim Sheba Medical Center, The Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Polina', 'Initials': 'P', 'LastName': 'Cohen Goichman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Huszti', 'Affiliation': 'Biostatistics Research Unit, University Health Network, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Abu Rmeileh', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Shriki', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Abutbul', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Zvi G', 'Initials': 'ZG', 'LastName': 'Fridlender', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Neville', 'Initials': 'N', 'LastName': 'Berkman', 'Affiliation': 'Institute of Pulmonary Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106162']
2050,32985946,Caffeine Boosts Preparatory Attention for Reward-related Stimulus Information.,"The intake of caffeine and the prospect of reward have both been associated with increased arousal, enhanced attention, and improved behavioral performance on cognitive tasks, but how they interact to exert these effects is not well understood. To investigate this question, we had participants engage in a two-session cued-reward cognitive task while we recorded their electrical brain activity using scalp electroencephalography. The cue indicated whether monetary reward could be received for fast and accurate responses to a color-word Stroop stimulus that followed. Before each session, participants ingested decaffeinated coffee with either caffeine (3-mg/kg bodyweight) or placebo (3-mg/kg bodyweight lactose). The behavioral results showed that both caffeine and reward-prospect improved response accuracy and speed. In the brain, reward-prospect resulted in an enlarged frontocentral slow wave (contingent negative variation, or CNV) and reduced posterior alpha power (indicating increased cortical activity) before stimulus presentation, both neural markers for preparatory attention. Moreover, the CNV enhancement for reward-prospect trials was considerably more pronounced in the caffeine condition as compared to the placebo condition. These interactive neural enhancements due to caffeine and reward-prospect were mainly visible in preparatory attention activity triggered by the cue (CNV). In addition, some interactive neural enhancements in the processing of the Stroop target stimulus that followed were also observed. The results suggest that caffeine facilitates the neural processes underlying attentional preparation and stimulus processing, especially for task-relevant information.",2021,"Moreover, the CNV enhancement for reward-prospect trials was considerably more pronounced in the caffeine condition as compared to the placebo condition.",[],"['decaffeinated coffee with either caffeine', '2-session cued-reward cognitive task while recording their electrical brain activity using scalp electroencephalography', 'caffeine', 'Caffeine', 'placebo']","['response accuracy and speed', 'enlarged contingent negative variation (CNV) and reduced posterior alpha power', 'CNV enhancement for reward-prospect trials']",[],"[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0009850', 'cui_str': 'Contingent negative variation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",,0.0764083,"Moreover, the CNV enhancement for reward-prospect trials was considerably more pronounced in the caffeine condition as compared to the placebo condition.","[{'ForeName': 'Berry', 'Initials': 'B', 'LastName': 'van den Berg', 'Affiliation': 'University of Groningen, The Netherlands.'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'de Jong', 'Affiliation': 'University of Groningen, The Netherlands.'}, {'ForeName': 'Marty G', 'Initials': 'MG', 'LastName': 'Woldorff', 'Affiliation': 'Duke University.'}, {'ForeName': 'Monicque M', 'Initials': 'MM', 'LastName': 'Lorist', 'Affiliation': 'University of Groningen, The Netherlands.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01630']
2051,32980656,Effectiveness of the Super Skills for Life programme in enhancing the emotional wellbeing of children and adolescents in residential care institutions in a low- and middle-income country: A randomised waitlist-controlled trial.,"BACKGROUND
The present study examined the effectiveness of a transdiagnostic prevention programme, Super Skills for Life (SSL), among children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius using a randomised waitlist-controlled trial (RCT). SSL is based on the principles of cognitive behavioural therapy, behavioural activation, social skills training, and uses video-feedback and cognitive preparation as part of the treatment.
METHODS
The RCT involved 100 children and adolescents aged 9 to 14 years, from six RCIs, randomly allocated to either an SSL intervention group (IG) or a waitlist-control (WLC) group. A set of questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control, were completed at baseline, post-intervention and 3-month follow-up. Participants also completed a 2-min video speech task during the first and final sessions of the SSL intervention.
RESULTS
Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up. These findings were not replicated among children in the WLC.
LIMITATIONS
The small sample size and lack of an active control group were the major limitations of this study.
CONCLUSIONS
This study provides evidence for the effectiveness of a transdiagnostic prevention programme for emotional problems in RCIs in a low- and middle-income country.",2021,"RESULTS
Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","['children and adolescents with emotional problems in residential care institutions (RCIs) in the low- and middle-income country of Mauritius', 'children and adolescents in residential care institutions in a low- and middle-income country', 'emotional problems in RCIs in a low- and middle-income country', '100 children and adolescents aged 9 to 14 years, from six RCIs']","['transdiagnostic prevention programme', 'SSL intervention group (IG) or a waitlist-control (WLC', 'Super Skills for Life programme', 'transdiagnostic prevention programme, Super Skills for Life (SSL', 'SSL']","['emotional wellbeing', 'maladaptive emotion regulation strategies', 'internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control', 'questionnaires measuring internalising and externalising problems, emotion regulation and self-esteem, and experimental tasks measuring attentional bias and inhibitory control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0024944', 'cui_str': 'Mauritius'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C4277667', 'cui_str': 'Attentional Biases'}]",100.0,0.0681738,"RESULTS
Children and adolescents in the IG showed significant improvements in internalising symptoms (e.g. anxiety and depression), externalising symptoms (e.g. conduct problems and hyperactivity), and inhibitory control, and an increase in adaptive (except putting into perspective strategy) and decrease in maladaptive emotion regulation strategies, at both post-intervention and follow-up.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Ramdhonee-Dowlot', 'Affiliation': 'Department of Psychology, University of Roehampton, UK. Electronic address: ramdhonk@roehampton.ac.uk.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Balloo', 'Affiliation': 'University of Surrey, UK.'}, {'ForeName': 'Cecilia A', 'Initials': 'CA', 'LastName': 'Essau', 'Affiliation': 'Department of Psychology, University of Roehampton, UK.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.053']
2052,32987227,Family Integrated Care (FICare): Positive impact on behavioural outcomes at 18 months.,"BACKGROUND
Children born very preterm demonstrate behavioural challenges due to clinical factors, exposure to the high stress environment of intensive care, and separation from parents during neonatal hospitalization at a critical stage in development. Family Integrated Care (FICare) significantly reduced parent stress and anxiety, and improved neonatal outcomes.
AIMS
To examine the impact of FICare on behavioural outcomes at 18-21 months corrected age (CA), and assess possible mediation through parenting or infant growth.
STUDY DESIGN AND METHODS
A prospective cohort study enrolling infants under 33 weeks gestation and parents from the FICare cluster randomized controlled trial. Primary outcome was behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA). Parent child variables were measured with the Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth.
RESULTS
Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21 months CA. FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01). At 12 months CA, the NCAST Child subtotal score was higher and the PSI-Child Domain score was lower in FICare infants than non-FICare infants. The PSI-Child domain was identified as a possible mediator of FICare on child behaviour (mediation effect 1.28, -2.96-0.02, p = 0.044).
CONCLUSION
FICare in the NICU has a sustained effect on child behaviour, improving self-regulation at 18-21 months CA.",2020,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","['A prospective cohort study enrolling infants under 33\xa0weeks gestation and parents from the FICare cluster randomized controlled trial', 'Children born very preterm', 'Subjects included 123 FICare infants and 62 standard care controls evaluated at 18-21\xa0months CA']","['FICare', 'Family Integrated Care (FICare']","['parent stress and anxiety, and improved neonatal outcomes', 'Nursing Child Assessment Satellite Training (NCAST), Parenting Stress Index (PSI) and infant growth', 'behavioural outcomes', 'PSI-Child Domain score', 'lower ITSEA Dysregulation', 'NCAST Child subtotal score', 'behaviour assessed by the Infant Toddler Social Emotional Assessment (ITSEA', 'self-regulation skills', 'child behaviour, improving self-regulation']","[{'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021272', 'cui_str': 'Infant care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",123.0,0.0623273,"FICare infants demonstrated lower ITSEA Dysregulation, indicating better self-regulation skills, compared with the control group (T-score 41.7 vs 46.6, p < 0.01).","[{'ForeName': 'Paige Terrien', 'Initials': 'PT', 'LastName': 'Church', 'Affiliation': ""Sunnybrook Health Sciences Centre, Department of Newborn and Developmental Paediatrics, 2075 Bayview Avenue, M4-234, Toronto, ON M4N 3M5, Canada; University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada.""}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Grunau', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Mirea', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Petrie', 'Affiliation': ""BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': ""Alberta Children's Hospital Research Institute, Foothills Medical Centre, University of Calgary, 1403, 29th Street NW, Calgary, AB T2N 2T9, Canada.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Synnes', 'Affiliation': ""University of British Columbia, Department of Pediatrics and BC Children's Research Institute, 4500 Oak Street, Vancouver, BC V6H 3N1, Canada; BC Women's Hospital, 4500 Oak St, Vancouver, BC V6H 3N4, Canada.""}, {'ForeName': 'Xiang Y', 'Initials': 'XY', 'LastName': 'Ye', 'Affiliation': 'Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': ""University of Toronto, Department of Paediatrics, 27 King's College Cir, Toronto, ON M5S 3H7, Canada; Maternal-Infant Care Research Centre, Mount Sinai Hospital, 700 University Avenue, Suite 8-500, Toronto, ON M5G 1X6, Canada; Mount Sinai Hospital, Department of Paediatrics, 600 University Avenue, Toronto, ON M5G 1X5, Canada. Electronic address: karel.obrien@sinaihealth.ca.""}]",Early human development,['10.1016/j.earlhumdev.2020.105196']
2053,32877582,Trial of Sodium Phenylbutyrate-Taurursodiol for Amyotrophic Lateral Sclerosis.,"BACKGROUND
Sodium phenylbutyrate and taurursodiol have been found to reduce neuronal death in experimental models. The efficacy and safety of a combination of the two compounds in persons with amyotrophic lateral sclerosis (ALS) are not known.
METHODS
In this multicenter, randomized, double-blind trial, we enrolled participants with definite ALS who had had an onset of symptoms within the previous 18 months. Participants were randomly assigned in a 2:1 ratio to receive sodium phenylbutyrate-taurursodiol (3 g of sodium phenylbutyrate and 1 g of taurursodiol, administered once a day for 3 weeks and then twice a day) or placebo. The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks. Secondary outcomes were the rates of decline in isometric muscle strength, plasma phosphorylated axonal neurofilament H subunit levels, and the slow vital capacity; the time to death, tracheostomy, or permanent ventilation; and the time to death, tracheostomy, permanent ventilation, or hospitalization.
RESULTS
A total of 177 persons with ALS were screened for eligibility, and 137 were randomly assigned to receive sodium phenylbutyrate-taurursodiol (89 participants) or placebo (48 participants). In a modified intention-to-treat analysis, the mean rate of change in the ALSFRS-R score was -1.24 points per month with the active drug and -1.66 points per month with placebo (difference, 0.42 points per month; 95% confidence interval, 0.03 to 0.81; P = 0.03). Secondary outcomes did not differ significantly between the two groups. Adverse events with the active drug were mainly gastrointestinal.
CONCLUSIONS
Sodium phenylbutyrate-taurursodiol resulted in slower functional decline than placebo as measured by the ALSFRS-R score over a period of 24 weeks. Secondary outcomes were not significantly different between the two groups. Longer and larger trials are necessary to evaluate the efficacy and safety of sodium phenylbutyrate-taurursodiol in persons with ALS. (Funded by Amylyx Pharmaceuticals and others; CENTAUR ClinicalTrials.gov number, NCT03127514.).",2020,"The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks.","['Amyotrophic Lateral Sclerosis', 'persons with ALS', '177 persons with ALS were screened for eligibility, and 137', 'persons with amyotrophic lateral sclerosis (ALS', 'enrolled participants with definite ALS who had had an onset of symptoms within the previous 18 months']","['sodium phenylbutyrate-taurursodiol (3 g of sodium phenylbutyrate and 1 g of taurursodiol', 'sodium phenylbutyrate-taurursodiol', 'placebo', 'Sodium Phenylbutyrate-Taurursodiol']","['rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range', 'mean rate of change in the ALSFRS-R score', 'slower functional decline', 'efficacy and safety', 'Adverse events', 'rates of decline in isometric muscle strength, plasma phosphorylated axonal neurofilament H subunit levels, and the slow vital capacity; the time to death, tracheostomy, or permanent ventilation; and the time to death, tracheostomy, permanent ventilation, or hospitalization', 'ALSFRS-R score', 'neuronal death']","[{'cui': 'C0002736', 'cui_str': 'Amyotrophic lateral sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0718066', 'cui_str': 'sodium phenylbutyrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4296567', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4305309', 'cui_str': 'Amyotrophic Lateral Sclerosis Functional Rating Scale Revised score'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1505576', 'cui_str': 'NEFH protein, human'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0907533', 'cui_str': 'NOS1 protein, human'}]",177.0,0.608843,"The primary outcome was the rate of decline in the total score on the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R; range, 0 to 48, with higher scores indicating better function) through 24 weeks.","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Paganoni', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hendrix', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Elliott', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Maiser', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Caress', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Owegi', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Quick', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Goutman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Daragh', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Heiman-Patterson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Rothstein', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Kasarskis', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Liberty', 'Initials': 'L', 'LastName': 'Jenkins', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Miller', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Stephen N', 'Initials': 'SN', 'LastName': 'Scelsa', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Tuan H', 'Initials': 'TH', 'LastName': 'Vu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Christina N', 'Initials': 'CN', 'LastName': 'Fournier', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Glass', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Johnson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Namita A', 'Initials': 'NA', 'LastName': 'Goyal', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Pattee', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Andres', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Suma', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Dagostino', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Samuel P', 'Initials': 'SP', 'LastName': 'Dickson', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Ellison', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Hendrix', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Gale', 'Initials': 'G', 'LastName': 'Kittle', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ostrow', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Pothier', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Randall', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Shefner', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Sherman', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Tustison', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Prasha', 'Initials': 'P', 'LastName': 'Vigneswaran', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Klee', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Leslie', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Rudolph E', 'Initials': 'RE', 'LastName': 'Tanzi', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gilbert', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Yeramian', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schoenfeld', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}, {'ForeName': 'Merit E', 'Initials': 'ME', 'LastName': 'Cudkowicz', 'Affiliation': ""From the Sean M. Healey and AMG Center for ALS and the Neurological Clinical Research Institute, Massachusetts General Hospital, Harvard Medical School (S.P., J.D.B., S.B., M.C., D.D., M.M., J.O., L.P., A.V.S., E.T., P.V., J. Walker, H.Y., R.E.T., M.E.C.), the Biostatistics Center, Massachusetts General Hospital, Harvard Medical School (E.A.M., J. Chan, D.S.), and Spaulding Rehabilitation Hospital, Harvard Medical School (S.P.), Boston, the University of Massachusetts Memorial Medical Center, Worcester (M.A.O.), and Amylyx Pharmaceuticals (J. Cohen, J. Klee, K.L., P.D.Y.) and Harvard University (W.G.), Cambridge - all in Massachusetts; Pentara, Millcreek, UT (S.H., S.P.D., N.E., K.H.); Swedish Neuroscience Institute, Seattle (M.A.E.); Hennepin Healthcare, Minneapolis (S.M.); the Department of Neurology, Oregon Health and Science University, Portland (C.K.); the Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC (J.B.C.); the Department of Neurology, Ohio State University College of Medicine, Columbus (A.Q.); the Department of Neurology, University of Florida College of Medicine, Gainesville (J. Wymer); the Department of Neurology, University of Michigan, Ann Arbor (S.A.G.); Texas Neurology, Dallas (D.H.); the Department of Neurology, Lewis Katz School of Medicine, Temple University (T.H.-P.), and the Department of Neurology, University of Pennsylvania Perelman School of Medicine (C.Q.) - both in Philadelphia; Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disease, University of Texas Health Science Center at San Antonio, San Antonio (C.E.J.); the Brain Science Institute and Department of Neurology, Johns Hopkins University, Baltimore (J.D.R.); the Department of Neurology, University of Kentucky College of Medicine, Lexington (E.J.K.); California Pacific Medical Center and Forbes Norris MDA-ALS Research and Treatment Center, San Francisco (J. Katz, L.J.); Barrow Neurological Institute, Phoenix, AZ (S.L., M.H., G.K., R.R., J.M.S.); the Department of Neurology, Washington University School of Medicine in St. Louis, St. Louis (T.M.M.); the Department of Neurology, Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai, New York (S.N.S.); the Department of Neurology, University of South Florida Morsani College of Medicine, Tampa (T.H.V.); the Departments of Neurology and Pathology, Emory University School of Medicine, Atlanta (C.N.F., J.D.G.); Ochsner Health System, New Orleans (K.M.J.); the Department of Neurology, University of Iowa Carver College of Medicine, Iowa City (A.S.); the Department of Neurology, University of California, Irvine, School of Medicine, Irvine (N.A.G.); Neurology Associates, Lincoln, NB (G.L.P.); independent consultant, Nobleboro, ME (P.L.A.); and Statistics Collaborative, Washington, DC (J. Wittes).""}]",The New England journal of medicine,['10.1056/NEJMoa1916945']
2054,32956964,Efficacy of learning through play plus intervention to reduce maternal depression in women with malnourished children: A randomized controlled trial from Pakistan ✰ .,"BACKGROUND
The risk factors and adverse outcomes related to maternal depression and child malnutrition are a leading cause of morbidity and mortality in low and middle-income countries (LMIC) including Pakistan. Above 25% of women suffer from maternal depression. Up to 50% children are under-nourished which contributes to 35% of all under-5 deaths in the country.
AIM
To determine the efficacy of Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention to reduce maternal depression in mothers with undernourished children.
METHODS
In this randomised controlled trial, all eligible mothers presenting to the paediatric departments were invited to participate in the study. Out of the total 256 mothers screened, 107 were included, 54 of those were randomly allocated to LTP Plus group and 53 to treatment as usual (TAU). Edinburgh Postnatal Depression Scale (EPDS) was used to screen for depression. Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D) were used to measure the severity of depression, mother-child attachment, level of support and health related quality of life dimensions. Assessments were completed at baseline, end of intervention (3 months from baseline) and at 6 months from baseline.
RESULTS
Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
CONCLUSION
The outcomes of LTP Plus intervention for mothers of malnourished children show promising results in reducing maternal depression and improving child outcomes. A full trial with longer-term outcomes and cost-effectiveness needs to be conducted.",2021,"RESULTS
Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","['Out of the total 256 mothers screened, 107 were included, 54 of those', 'mothers with undernourished children', 'eligible mothers presenting to the paediatric departments were invited to participate in the study', 'mothers of malnourished children', 'women with malnourished children']","['Learning through Play Plus Thinking Healthy Program (LTP Plus) intervention', 'learning through play plus intervention', 'LTP Plus group and 53 to treatment as usual (TAU', 'LTP Plus intervention']","['Edinburgh Postnatal Depression Scale (EPDS', 'depression (p<0.001), social support', 'maternal depression', 'severity of depression, mother-child attachment, level of support and health related quality of life dimensions', 'maternal depression and improving child outcomes', 'quality of life', 'Hamilton Depression Rating Scale (HDRS), Maternal Attachment Inventory (MAI), Social Support Scale (OSLO-3) and the Euro-QoL (EQ-5D']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587482', 'cui_str': 'Pediatric department'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206249', 'cui_str': 'Long-Term Potentiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1533125', 'cui_str': 'Euro'}]",,0.148806,"RESULTS
Mothers in the LTP Plus group significantly showed improvements in depression (p<0.001), social support (p = 0.02) and quality of life (p<0.001) at the end of the intervention (LTP Plus), as compared to the TAU group, which were sustained up to 6 months after baseline.
","[{'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'University of Manchester United Kingdom; Lancashire Care NHS Foundation Trust. Electronic address: Nusrat.husain@manchester.ac.uk.'}, {'ForeName': 'Tayyeba', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Lancashire Care NHS Foundation Trust; Pakistan Institute of Living and Learning.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'University of Liverpool United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Raza-Ur-Rehman', 'Affiliation': 'Dow University of Health Sciences.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Saeed', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Naeem', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Sami Ul', 'Initials': 'SU', 'LastName': 'Haq', 'Affiliation': 'Pakistan Institute of Living and Learning.'}, {'ForeName': 'Farhat', 'Initials': 'F', 'LastName': 'Jaffery', 'Affiliation': 'Karachi Medical and Dental College Pakistan.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'University of Toronto.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Naeem', 'Affiliation': 'Centre for Addiction & Mental Health, Toronto, Canada.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chaudhry', 'Affiliation': 'Pakistan Institute of Living and Learning.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.001']
2055,32957009,Meal skipping and cognition along a spectrum of restrictive eating.,"OBJECTIVE
Inadequate nutrition adversely impacts brain development and cognitive functioning (Pollitt et al., 1983). Studies examining the acute impact of eating regular meals on cognition have reported inconsistent findings, necessitating the exploration of individual differences in samples contributing to equivocal results. The present study examines the impact of skipping lunch on cognitive ability in college-aged students by including eating restraint as a moderator.
METHODS
Participants were 99 college-aged students (M = 19.7 years, SD = 1.5) randomized to a blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting, and eating disorder symptomology.
RESULTS
Regressing long and short-term memory on the lunch manipulation, eating restraint scores, and their interaction revealed significant interactions: those who had lunch had superior memory performance, but only for those reporting lower levels of eating restraint. Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
CONCLUSIONS
Results suggest that skipping lunch may have immediate consequences on cognition, however, cognitive enhancing effects may be diminished in the presence of even low levels of eating restraint. Findings highlight the significance of purported subclinical levels of eating restraint and may inform health education strategies.",2020,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","['college-aged students by including eating restraint as a moderator', 'Participants were 99 college-aged students (M\xa0=\xa019.7\xa0years, SD\xa0=\xa01.5) randomized to a']","['skipping lunch', ""blinded 'lunch' or 'lunch-omission' condition, and assessed on memory, attention, processing speed, set shifting""]","['cognitive ability', 'superior memory performance', 'lunch manipulation, eating restraint scores']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0492838,"Regressing set shifting speed on the manipulation, those who had lunch had slower set shifting speed than those who skipped, but only for those reporting lower levels of eating restraint.
","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA. Electronic address: nandinid@stanford.edu.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Bidopia', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Datta', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gaurie', 'Initials': 'G', 'LastName': 'Mittal', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Franca', 'Initials': 'F', 'LastName': 'Alphin', 'Affiliation': 'Duke University Department of Family Medicine and Community Health, Durham, NC, USA.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Marsh', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Gavan J', 'Initials': 'GJ', 'LastName': 'Fitzsimons', 'Affiliation': 'Duke University Fuqua School of Business, Durham, NC, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Strauman', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Zucker', 'Affiliation': 'Duke University Department of Psychology and Neuroscience, Durham, NC, USA; Duke University School of Medicine Department of Psychiatry & Behavioral Sciences, Durham, NC, USA.'}]",Eating behaviors,['10.1016/j.eatbeh.2020.101431']
2056,33232739,The influence of a moderate temperature drift on thermal physiology and perception.,"Humans spend approximately 80-90% of their time indoors. In current practice, indoor temperatures in many buildings are controlled very tightly. However, allowing more variation in indoor temperature results in more energy-efficient buildings and could potentially improve human metabolic and cardiovascular health. Therefore, this study aimed to evaluate the effect of a drifting ambient temperature versus a fixed ambient temperature on thermal physiological parameters and subjective perception. A cross-over intervention design was conducted in 16 healthy men (age 26 ± 4 y; BMI 23.0 ± 1.7 kg/m 2 ) between July 2018 and May 2019. All participants underwent two whole-day (8:30-17:00) experimental sessions, during which they were exposed to a drifting (17-25°C with a morning ramp of 2.58°C/h and afternoon ramp of -2.58°C/h) or constant ambient temperature (21°C) in randomized order. The experiments took place in respiratory chambers, which simulated a typical office environment and in which temperature conditions can be controlled accurately. Throughout the experimental sessions core and skin temperature, heart rate, blood pressure, energy expenditure as well as activity levels were measured. Subjective thermal perception, such as thermal comfort and sensation, was assessed by questionnaires every 30 min. Results reveal that energy expenditure was higher in the morning during the drifting session, which was accompanied by an increase in activity levels. Both drifting and fixed sessions were judged as comfortable although during the drift thermal comfort was lower in the morning and afternoon and higher during midday. The results indicate that a drifting ambient temperature can be applied in practice, and as such, can contribute to a healthier and more sustainable built environment. More research is needed to understand the role of a drifting temperature on the long term.",2020,Both drifting and fixed sessions were judged as comfortable although during the drift thermal comfort was lower in the morning and afternoon and higher during midday.,['16 healthy men (age 26 ± 4 y; BMI 23.0 ± 1.7 kg/m 2 ) between July 2018 and May 2019'],"['drifting (17-25˚C with a morning ramp of 2.58˚C/h and afternoon ramp of -2.58˚C/h) or constant ambient temperature (21˚C', 'drifting ambient temperature versus a fixed ambient temperature']","['energy expenditure', 'activity levels', 'skin temperature, heart rate, blood pressure, energy expenditure as well as activity levels', 'human metabolic and cardiovascular health', 'thermal physiological parameters and subjective perception', 'Subjective thermal perception, such as thermal comfort and sensation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0542496', 'cui_str': 'Ambient temperature'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",16.0,0.0158419,Both drifting and fixed sessions were judged as comfortable although during the drift thermal comfort was lower in the morning and afternoon and higher during midday.,"[{'ForeName': 'Yoanna M', 'Initials': 'YM', 'LastName': 'Ivanova', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pallubinsky', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Kramer', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, Maastricht University, Maastricht, the Netherlands; Department of the Built Environment, Eindhoven University of Technology, Eindhoven, the Netherlands.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'van Marken Lichtenbelt', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM, Maastricht University, Maastricht, the Netherlands. Electronic address: markenlichtenbelt@maastrichtuniversity.nl.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113257']
2057,33232794,Distinct effects of low-intensity physical activity in the evening on sleep quality in older women: A comparison of exercise and housework.,"BACKGROUND
The effects of intensity, type, and time of day of physical activity on sleep are not well understood. An appropriate increase in core body temperature, due to physical activity during daytime, aids sleep in older adults. Our previous study showed that evening exercise has more positive effects on sleep quality in older adults when compared with morning exercise. However, older adults who do not exercise form a large part of the population. This study aimed to examine the distinct effects of low-intensity exercise and housework during the evening on sleep quality in older women.
METHODS
This randomized crossover study included 10 healthy older women aged 65-79 years. The participants engaged in low-intensity physical activity for 30 min, either aerobic exercise (70 steps per minute), housework (at the same intensity), or remained sedentary (control) 3 h before bedtime. Sleep was recorded polysomnographically, and self-reported sleep quality was assessed the next morning using the Oguri-Shirakawa-Azumi sleep inventory, Middle-Aged and Aged version (OSA-MA) questionnaire.
RESULTS
Compared with the control trial, core body temperature was significantly elevated in participants after each activity trial (0.5 ± 0.4 and 0.4 ± 0.4 °C for housework and aerobic exercise, respectively). There was a significant difference in sleep latency (14.2 ± 19.1, 9.9 ± 15.6, and 4.2 ± 3.5 min for control, housework, and aerobic exercise, respectively; ANOVA P = 0.011) among the trials. The delta power density after aerobic exercise was significantly higher than that after the control trial. We observed an increase of 53% and 15% in delta power during the 1st hour of sleep as a result of aerobic exercise and housework, respectively. The total score on OSA-MA was significantly higher after aerobic exercise (91.0 ± 5.4, 88.1 ± 6.9, and 108.6 ± 5.9 points for control, housework, and exercise, respectively).
CONCLUSIONS
Engaging in low-intensity aerobic exercise in the evening improved polysomnographic and self-reported sleep quality. Although housework increased core body temperature to the same level as that observed after aerobic exercise, self-reported sleep quality after housework was lower than that after aerobic exercise.",2020,"The total score on OSA-MA was significantly higher after aerobic exercise (91.0 ± 5.4, 88.1 ± 6.9, and 108.6 ± 5.9 points for control, housework, and exercise, respectively).
","['older adults', 'older women', '10 healthy older women aged 65-79\u202fyears', 'older adults who do not exercise form a large part of the population']","['low-intensity exercise and housework', 'low-intensity physical activity', 'aerobic exercise', 'Engaging in low-intensity aerobic exercise', 'evening exercise']","['sleep quality', 'delta power density after aerobic exercise', 'Sleep was recorded polysomnographically, and self-reported sleep quality', 'polysomnographic and self-reported sleep quality', 'sleep latency', 'Oguri-Shirakawa-Azumi sleep inventory, Middle-Aged and Aged version (OSA-MA) questionnaire', 'total score on OSA-MA']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020053', 'cui_str': 'Housework'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0587117', 'cui_str': 'Evening'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",10.0,0.0959412,"The total score on OSA-MA was significantly higher after aerobic exercise (91.0 ± 5.4, 88.1 ± 6.9, and 108.6 ± 5.9 points for control, housework, and exercise, respectively).
","[{'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, 1-2 Kasuga, Tsukuba, Ibaraki 305-8550, Japan. Electronic address: seol.jaehoon.ge@u.tsukuba.ac.jp.'}, {'ForeName': 'Insung', 'Initials': 'I', 'LastName': 'Park', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kokudo', 'Affiliation': 'Doctoral Program in Sports Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8574, Japan.'}, {'ForeName': 'Simeng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Suzuki', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Yajima', 'Affiliation': 'Department of Nutritional Physiology, Faculty of Pharmaceutical Sciences, Josai University, 1-1 Keyakidai, Sakado, Saitama 350-0295, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Satoh', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Kumpei', 'Initials': 'K', 'LastName': 'Tokuyama', 'Affiliation': 'International Institute for Integrative Sleep Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Okura', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, 1-2 Kasuga, Tsukuba, Ibaraki 305-8550, Japan; Faculty of Health and Sport Sciences, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8574, Japan.'}]",Experimental gerontology,['10.1016/j.exger.2020.111165']
2058,33001232,Adipose depot-specific effects of 16 weeks of pioglitazone on in vivo adipogenesis in women with obesity: a randomised controlled trial.,"AIMS/HYPOTHESIS
In vitro and rodent studies suggest that pioglitazone, a thiazolidinedione, can promote adipogenesis in adipose tissue (AT); however, there is a lack of in vivo studies in humans to support these findings. The objectives of this randomised, placebo-controlled, parallel-arm trial were to test if pioglitazone stimulates in vivo adipogenesis in the subcutaneous adipose tissue depots and if these measures were related to metabolic health outcomes in women with obesity.
METHODS
Forty-one healthy women with obesity (20 black; 21 white; 29 ± 6 years; BMI 32.0 ± 1.7 kg/m 2 ; 44.0 ± 3.6% body fat) were randomised to consume 30 mg/day of pioglitazone (n = 21) or placebo (n = 20) for 16 weeks. SAS v9.4 was used to generate the block randomisation code sequence (stored in password-protected files) with a 1:1 allocation ratio. The participants and study staff involved in assessing and analysing data outcomes were blinded to the group assignments. The trial was conducted at Pennington Biomedical Research Center and ended in 2016. At baseline and post-intervention, subcutaneous abdominal (scABD) and femoral (scFEM) AT biopsies were collected, and in vivo cellular kinetics (primary endpoint of the trial) were assessed by an 8 week labelling protocol of deuterium ( 2 H) into the DNA of adipose cells. Body composition was measured by dual-energy x-ray absorptiometry (DXA), scABD and visceral AT (VAT) by MRI, ectopic fat by 1 H-MRS, and insulin sensitivity by an OGTT.
RESULTS
After the 16 week intervention, there was a significant decrease in visceral fat (VAT:total abdominal AT [as a %]; p = 0.002) and an increase in the Matsuda index (i.e. improved insulin sensitivity; p = 0.04) in the pioglitazone group relative to the placebo group. A significant increase in the formation of new adipocytes was observed in the scFEM (Δ = 3.3 ± 1.6%; p = 0.04) but not the scABD depot (Δ = 2.0 ± 2.1%; p = 0.32) in the pioglitazone group relative to the placebo group. No serious adverse events were reported.
CONCLUSIONS/INTERPRETATION
Pioglitazone may elicit distinct differences in in vivo adipogenesis in subcutaneous adipose depots in women with obesity, with increased rates in the protective scFEM. Trial registration ClinicalTrials.gov NCT01748994 Funding This study was funded by R01DK090607, P30DK072476, and R03DK112006 from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health. The Robert C. and Veronica Atkins Foundation. Graphical abstract.",2021,"No serious adverse events were reported.
","['U54 GM104940 from the National Institute of General Medical Sciences of the National Institutes of Health', 'Forty-one healthy women with obesity (20 black; 21 white; 29\u2009±\u20096\xa0years; BMI 32.0\u2009±\u20091.7\xa0kg/m 2 ; 44.0\u2009±\u20093.6% body fat', 'women with obesity']","['thiazolidinedione', 'placebo', 'pioglitazone', 'consume 30\xa0mg/day of pioglitazone', 'Pioglitazone']","['formation of new adipocytes', 'metabolic health outcomes', 'dual-energy x-ray absorptiometry (DXA), scABD and visceral AT (VAT) by MRI, ectopic fat by 1 H-MRS, and insulin sensitivity', 'visceral fat (VAT:total abdominal AT', 'subcutaneous abdominal (scABD) and femoral (scFEM', 'Body composition', 'Matsuda index', 'serious adverse events']","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]","[{'cui': 'C0289779', 'cui_str': '2,4-thiazolidinedione'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",41.0,0.311233,"No serious adverse events were reported.
","[{'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'White', 'Affiliation': 'Physiology of Human Adipose Tissue, Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, USA. ursula.white@pbrc.edu.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Fitch', 'Affiliation': 'Nutritional Sciences and Toxicology, University of California at Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Biostatistics, Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, USA.'}, {'ForeName': 'Marc K', 'Initials': 'MK', 'LastName': 'Hellerstein', 'Affiliation': 'Nutritional Sciences and Toxicology, University of California at Berkeley, Berkeley, CA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Human Translational Physiology, Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, LA, USA.'}]",Diabetologia,['10.1007/s00125-020-05281-7']
2059,33000366,Influence of theta-burst transcranial magnetic stimulation over the dorsolateral prefrontal cortex on emotion processing in healthy volunteers.,"Repetitive transcranial magnetic stimulation is a potential treatment option for depression, with the newer intermittent theta-burst stimulation (iTBS) protocols providing brief intervention. However, their mechanism of action remains unclear. We investigated the hypothesis that iTBS influences brain circuits involved in emotion processing that are also affected by antidepressants. We predicted that iTBS would lead to changes in performance on emotion-processing tasks. We investigated the effects of intermittent TBS (iTBS) over the left dorsolateral prefrontal cortex (DLPFC) on the processing of emotional information (word recall and categorization, facial emotion recognition, and decision-making) in 28 healthy volunteers by contrasting these effects with those of sham stimulation. Each volunteer received iTBS and sham stimulation in a blinded crossover design and completed the emotion-processing tasks before and after stimulation. Compared to sham stimulation, iTBS increased positive affective processing for word recall, yet had an unexpected effect on facial emotion recognition for happy and sad faces. There was no evidence of an effect on decision-making or word categorization. We found support for our hypothesis that iTBS influences emotion processing, though some changes were not in the expected direction. These findings suggest a possible common mechanism of action between iTBS and antidepressants, and a complex neural circuitry involved in emotion processing that could potentially be tapped into via brain stimulation. Future research should investigate the neural correlates of emotion processing more closely to inform future iTBS protocols.",2020,"Compared to sham stimulation, iTBS increased positive affective processing for word recall, yet had an unexpected effect on facial emotion recognition for happy and sad faces.","['28 healthy volunteers', 'healthy volunteers']","['iTBS and sham stimulation', 'Repetitive transcranial magnetic stimulation', 'iTBS', 'theta-burst transcranial magnetic stimulation', 'intermittent TBS (iTBS']","['emotional information (word recall and categorization, facial emotion recognition, and decision-making', 'emotion processing', 'decision-making or word categorization', 'facial emotion recognition for happy and sad faces']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}]",28.0,0.0588071,"Compared to sham stimulation, iTBS increased positive affective processing for word recall, yet had an unexpected effect on facial emotion recognition for happy and sad faces.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Dumitru', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th Floor, 149 Tottenham Court Rd, Fitzrovia, London, W1T 7BN, UK. ana.dumitru@ucl.ac.uk.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rocchi', 'Affiliation': 'Institute of Neurology, Department of Clinical and Movement Neurosciences, University College London, London, UK.'}, {'ForeName': 'Fedal', 'Initials': 'F', 'LastName': 'Saini', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Institute of Neurology, Department of Clinical and Movement Neurosciences, University College London, London, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Roiser', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th Floor, 149 Tottenham Court Rd, Fitzrovia, London, W1T 7BN, UK.'}, {'ForeName': 'Raphaelle M', 'Initials': 'RM', 'LastName': 'Richieri', 'Affiliation': 'Department of Psychiatry, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th Floor, 149 Tottenham Court Rd, Fitzrovia, London, W1T 7BN, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, Maple House, 6th Floor, 149 Tottenham Court Rd, Fitzrovia, London, W1T 7BN, UK.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00834-0']
2060,32998018,Glycemic qualification rate and frequency of self-monitoring blood glucose glycemic qualification rate and frequency of self-monitoring blood glucose (SMBG) in women with gestational diabetes mellitus (GDM).,"AIMS
To explore the relationship between blood glucose (BG) control rate and self-monitoring blood glucose (SMBG) compliance of women with gestational diabetes mellitus (GDM).
METHODS
Women with GDM (n = 309) were randomized to receive routine clinical prenatal care or additional online management. Follow-up visits were conducted every two weeks (noted here as T) from enrollment to delivery. SMBG records were used for the analysis.
RESULTS
Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period. Detailed data analysis on separate follow-up periods showed that the SMBG frequency was negatively correlated with the BG control rate in most Ts and that the BG control rate of T n-1 was negatively correlated with the SMBG frequency of T n in the adjacent T. Only in the intervention group was T 2 SMBG compliance not under the influence of the T 1 BG control rate.
CONCLUSIONS
Our data suggested that regardless of management approach, the BG control rate increased, and the SMBG frequency decreased as gestational weeks increased in women with GDM. Even in separate follow-up periods, the SMBG frequency was negatively correlated with the BG control rate both within one follow-up period and between two adjacent follow-up periods.",2020,Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period.,"['Women with GDM (n=309', 'women with GDM', 'women with gestational diabetes mellitus (GDM']",['routine clinical prenatal care or additional online management'],"['BG control rate and decreasing SMBG compliance', 'Glycemic qualification rate and frequency of self-monitoring blood glucose Glycemic qualification rate and frequency of self-monitoring blood glucose (SMBG', 'blood glucose (BG) control rate and self-monitoring blood glucose (SMBG) compliance', 'BG control rate', 'SMBG frequency of Tn', 'SMBG frequency']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",309.0,0.0292636,Both the intervention group and the control group had an increasing BG control rate and decreasing SMBG compliance during the whole follow-up period.,"[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Suhan', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Feiling', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China.'}, {'ForeName': 'Fenglian', 'Initials': 'F', 'LastName': 'Shi', 'Affiliation': 'Zhengzhou Central Hospital Affiliated to Zhengzhou University, No. 16 Tongbai North Road, Zhongyuan District, Zhengzhou, Henan Province 450007, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shenyang Maternity and Child Health Hospital, No. 41 Shenzhou Road, Shenhe District, Shenyang, Liaoning Province 110000, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""QuanZhou Women's and Children's Hospital, No. 700 Fengze Street, Quanzhou, Fujian Province 362000, China.""}, {'ForeName': 'Chuci', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Shenyang Women's and Children's Hospital, No. 87 Danan Street, Shenhe District, Shenyang, Liaoning Province 110011, China.""}, {'ForeName': 'Hongxiu', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Xiamen Maternal and Child Health Hospital, No. 10 Zhenhai Road, Xiamen, Fujian Province 361003, China.'}, {'ForeName': 'Weibo', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': ""Shunyi Women's & Children's Hospital of Beijing Children's Hospital, No. 1 Shunkang Road, Shunyi District, Beijing 101300, China.""}, {'ForeName': 'Cuiying', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Jinan Maternity and Child Care Hospital Affiliated to Shandong First Medical University, No. 2 Jianguoxiaojingsan Street, Shizhong District, Jinan, Shandong Province 250001, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Niu', 'Affiliation': ""Fuyang People's Hospital, No. 63 Luci Street, Yinzhou District, Fuyang, Anhui Province 236004, China.""}, {'ForeName': 'Xiaowen', 'Initials': 'X', 'LastName': 'Xue', 'Affiliation': 'Beijing Pinggu Hospital, No. 59 Xinping North Road, Pinggu District, Beijing 101200, China.'}, {'ForeName': 'Liangkun', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Beijing, 100730, China. Electronic address: MaLiangKun@pumch.cn.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108482']
2061,33002553,Comparative clinical study evaluating the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin therapy on diabetic patients with symptomatic coronary artery disease.,"BACKGROUND AND OBJECTIVE
Cardiovascular diseases (CVDs) remain the most identified cause of death in patients with diabetes mellitus (DM). This study aimed to evaluate the effect of adding Vildagliptin versus Glimepiride to ongoing Metformin on the biomarkers of inflammation, thrombosis, and atherosclerosis in T2DM patients with symptomatic coronary artery disease (CAD).
METHODS
This study included 80 patients with uncontrolled T2DM and symptomatic CAD who were randomized to add either Vildagliptin 50 mg/day ""group I"" or Glimepiride 4 mg/day ""group II"" to ongoing Metformin therapy (1000 mg/day). Blood samples were collected at baseline and 3 months after intervention for biochemical analysis of HbA1c %, IL-1β, adiponectin, hsCRP and lipid profile. Additionally atherogenic index (AI) and coronary risk index (CRI) were determined.
RESULTS
Three months after intervention and as compared to group II (Glimepiride/Metformin), group 1 (Vildagliptin/Metformin) showed significantly lower BMI (28.73 ± 3.48 versus 30.55 ± 3.15; p = 0.02), HbA1c (6.05 ± 0.72 versus 7.06 ± 0.89; p < 0.0001), hsCRP (0.96 ± 0.20 versus 1.72 ± 0.38; p < 0.0001), IL-1β (34.95 ± 10.01 versus 45.13 ± 10.26; p < 0.0001), TC (136 ± 23.45 versus 169 ± 35.72; p < 0.0001), TG (116 ± 29.10 versus 146 ± 56.58; p = 0.005), and CRI (2.47 ± 0.90 versus 3.65 ± 1.19; p < 0.0001) which was associated with significantly higher adiponectin and HDL-C (4.42 ± 1.29 versus 2.52 ± 1.86; p < 0.0001 and 61 ± 23.04 versus 48 ± 12.92; p = 0.003 respectively).
CONCLUSION
In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.",2020,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","['T2DM patients with symptomatic coronary artery disease (CAD', 'patients with diabetes mellitus (DM', '80 patients with uncontrolled T2DM and symptomatic CAD', 'Diabetic Patients with Symptomatic Coronary Artery Disease']","['Vildagliptin', 'Glimepiride', 'Glimepiride/metformin', 'Vildagliptin 50 mg/day ""group', 'Metformin therapy', 'Glimepiride/Metformin', 'Vildagliptin/Metformin', 'Metformin Therapy', 'Metformin']","['BMI', 'CRI', 'Additionally atherogenic index (AI) and coronary risk index (CRI', 'glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile', 'Blood samples', 'adiponectin and HDL-C', 'biomarkers of inflammation, thrombosis, and atherosclerosis', 'hsCRP', 'IL-1β']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2240780', 'cui_str': 'vildagliptin 50 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",80.0,0.0534605,"In patients with T2DM and symptomatic CAD, the addition of Vildagliptin to ongoing metformin showed better glycemic control, lower inflammatory markers (IL-1β and hsCRP), higher protective markers (adiponectin and HDL-C) and improved lipid profile compared to Glimepiride/metformin therapy.","[{'ForeName': 'Rehab', 'Initials': 'R', 'LastName': 'Werida', 'Affiliation': 'Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Damanhour University, Egypt. Electronic address: rehabwrieda@pharm.dmu.edu.eg.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Kabel', 'Affiliation': 'Clinical Pharmacy Unit, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Gamal', 'Initials': 'G', 'LastName': 'Omran', 'Affiliation': 'Biochemistry Department, Faculty of Pharmacy, Damanhour University, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shokry', 'Affiliation': 'Cardiology Department, Alexandria Armed Forces Hospital, Egypt.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Mostafa', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Egypt.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108473']
2062,33003044,Electrolyte Beverage Intake to Promote Hydration and Maintain Kidney Function in Guatemalan Sugarcane Workers Laboring in Hot Conditions.,"OBJECTIVES
To evaluate impact of electrolyte supplementation on hydration status and health outcomes in Guatemalan agricultural workers performing heavy work under hot climatic conditions.
METHODS
A 3-week pragmatic trial was conducted with a group of 50 workers during the 2017 to 2018 sugarcane harvest. Workers received an electrolyte hydration intervention during 2 of the 3 weeks. Blood and urine samples were collected each week.
RESULTS
Increased electrolyte intake resulted in less muscle injury. Kidney function was maintained across the intervention period. Workers were adequately hydrated and average electrolyte levels remained in normal ranges. Mild indications of hyponatremia occurred at higher levels of fluid intake.
CONCLUSIONS
This trial demonstrates the feasibility of maintaining workers' electrolyte levels under extremely hot and humid conditions while mitigating muscle injury. Electrolyte supplementation should be added to standard workplace water, rest, and shade interventions to protect workers.",2020,Kidney function was maintained across the intervention period.,"['Guatemalan Sugarcane Workers', 'group of 50 workers during the 2017-18 sugarcane harvest', 'Guatemalan agricultural workers performing heavy work under hot climatic conditions']","['Electrolyte supplementation', 'electrolyte supplementation', 'electrolyte hydration intervention']","['electrolyte intake', 'Blood and urine samples', 'hyponatremia', 'hydration status and health outcomes', 'Kidney function']","[{'cui': 'C0997177', 'cui_str': 'Sugarcane'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}]",,0.141553,Kidney function was maintained across the intervention period.,"[{'ForeName': 'Lyndsay', 'Initials': 'L', 'LastName': 'Krisher', 'Affiliation': 'Center for Health, Work, & Environment (Ms Krisher, Dr Butler-Dawson, Ms Dally, Ms Jaramillo, Dr Newman); Colorado Consortium on Climate Change and Human Health (Ms Krisher, Dr Butler-Dawson, Ms Dally, Ms Jaramillo, Dr Newman); Department of Environmental and Occupational Health (Ms Krisher, Dr Butler-Dawson, Ms Dally, Dr Newman), Colorado School of Public Health, University of Colorado Denver, Anschutz Medical Campus; Division of Kinesiology & Health, University of Wyoming, Laramie, Wyoming (Ms Yoder, Dr Johnson); Pantaleon, Guatemala (Dr Pilloni, Dr Cruz, Dr Asensio); Department of Epidemiology, Colorado School of Public Health (Dr Newman); Division of Pulmonary Sciences and Critical Care Medicine, Department of Medicine, School of Medicine (Dr Newman), University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Butler-Dawson', 'Affiliation': ''}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Yoder', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Pilloni', 'Affiliation': ''}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Dally', 'Affiliation': ''}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jaramillo', 'Affiliation': ''}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Cruz', 'Affiliation': ''}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Asensio', 'Affiliation': ''}, {'ForeName': 'Lee S', 'Initials': 'LS', 'LastName': 'Newman', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000002033']
2063,33006997,Couples data from north-western Tanzania: Insights from a survey of male partners of women enrolled in the MAISHA cluster randomized trial of an intimate partner violence prevention intervention.,"INTRODUCTION
Globally, around 30% of ever-partnered women have experienced physical and/or sexual intimate partner violence (IPV) during their lifetime. To date, most research into causes and prevention of IPV involves surveys of women, with little research into risk-factors for male perpetration. This paper describes a survey of male partners of women participating in the MAISHA cluster randomised trial (CRT) of an IPV prevention intervention, in Mwanza City, Tanzania. Using linked couples' data, we explore man-, woman-, and relationship-/household-level factors associated with physical and sexual IPV.
METHODS
Women were interviewed at baseline and 29-months follow-up. At follow-up, women were asked for consent to invite their partner to participate in the male survey. We describe response rates for the women's follow-up and male partners' surveys, and identify factors associated with women's consent to approach partners. Multivariate logistic regression was used to explore factors associated with women's past-year experiences of physical and sexual IPV.
RESULTS
512 (65%) partnered women consented for the partner to be approached, higher among intervention than control women. 425 (83%) male partners were interviewed. Women consenting were disproportionately likely to be in longer-term relationships. Past-year IPV was associated with lower consent among control women, but greater consent in the intervention arm. Factors associated with increased odds of physical IPV were women's childhood experiences of abuse, young age, women's lower income and women's attitudes justifying IPV. Sexual IPV was associated with women's childhood experiences of abuse, young age, educational disparity within couple, men's alcohol use and women's poor mental health.
CONCLUSIONS
We successfully conducted a survey of male partners with the full consent of women trial participants. The breadth of factors associated with IPV demonstrates the need for IPV prevention interventions to work with women and men, and specifically couples. Interventions should address risk-factors for both physical and sexual IPV.",2020,"Past-year IPV was associated with lower consent among control women, but greater consent in the intervention arm.","['425 (83%) male partners were interviewed', 'Women were interviewed at baseline and 29-months follow-up', 'male partners of women participating in the MAISHA cluster randomised trial (CRT) of an', 'male partners with the full consent of women trial participants', 'Couples data from north-western Tanzania', 'male partners of women enrolled in the MAISHA cluster randomized trial of an intimate partner violence prevention intervention']","['IPV prevention intervention, in Mwanza City, Tanzania', 'Sexual IPV']","['physical IPV', 'physical and/or sexual intimate partner violence (IPV']","[{'cui': 'C3844105', 'cui_str': '425'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",512.0,0.0520799,"Past-year IPV was associated with lower consent among control women, but greater consent in the intervention arm.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Abramsky', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Imma', 'Initials': 'I', 'LastName': 'Kapinga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Mshana', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Lees', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Christian Holm', 'Initials': 'CH', 'LastName': 'Hansen', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Ramadhan', 'Initials': 'R', 'LastName': 'Hashim', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Stöckl', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Saidi', 'Initials': 'S', 'LastName': 'Kapiga', 'Affiliation': 'Mwanza Intervention Trials Unit, Mwanza, Tanzania.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Harvey', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0240112']
2064,33009060,Dilation Modifies Association Between Symptoms and Esophageal Eosinophilia in Adult Patients With Eosinophilic Esophagitis.,"INTRODUCTION
We investigated whether dilation modifies the association between symptoms and esophageal eosinophilia (peak esophageal eosinophils/high-power field [eos/hpf]) in patients with eosinophilic esophagitis enrolled into a randomized trial comparing the efficacy of budesonide and fluticasone.
METHODS
Baseline Dysphagia Symptom Questionnaire and Eosinophilic Esophagitis Activity Index were available in 102 and 73 patients, respectively, of whom 56 and 39 underwent dilation at screening endoscopy before symptom assessment. The pair-wise relationship between Dysphagia Symptom Questionnaire, Eosinophilic Esophagitis Activity Index, and eos/hpf was analyzed with nonparametric correlations.
RESULTS
In nondilated patients, the association between baseline eos/hpf and symptoms was moderate and significant, although it was abolished in dilated patients.
DISCUSSION
Dilation modifies association between symptoms and eos/hpf (clinicaltrials.gov NCT02019758).",2020,"The pair-wise relationship between Dysphagia Symptom Questionnaire, Eosinophilic Esophagitis Activity Index, and eos/hpf was analyzed with nonparametric correlations.
","['102 and 73 patients, respectively, of whom 56 and 39 underwent dilation at screening endoscopy before symptom assessment', 'Adult Patients', 'patients with eosinophilic esophagitis']",['budesonide and fluticasone'],"['Dysphagia Symptom Questionnaire, Eosinophilic Esophagitis Activity Index, and eos/hpf', 'Baseline Dysphagia Symptom Questionnaire and Eosinophilic Esophagitis Activity Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.0515286,"The pair-wise relationship between Dysphagia Symptom Questionnaire, Eosinophilic Esophagitis Activity Index, and eos/hpf was analyzed with nonparametric correlations.
","[{'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Safroneeva', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Switzerland.'}, {'ForeName': 'Cary C', 'Initials': 'CC', 'LastName': 'Cotton', 'Affiliation': 'Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Alain M', 'Initials': 'AM', 'LastName': 'Schoepfer', 'Affiliation': 'Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Zwahlen', 'Affiliation': 'Institute of Social and Preventive Medicine, University of Bern, Switzerland.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Woosley', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000957']
2065,33009665,"No ""Wearing-Off Effect"" Seen in Quarterly or Monthly Dosing of Fremanezumab: Subanalysis of a Randomized Long-Term Study.","OBJECTIVE
To evaluate whether quarterly or monthly administration of fremanezumab for migraine prevention exhibits a pattern of decreased efficacy toward the end of the dosing interval (wearing-off effect).
BACKGROUND
The main goals of migraine preventive treatment are to reduce the frequency, severity, and duration of migraine attacks, and migraine-associated disability. Wearing-off refers to the phenomenon whereby clinical symptoms return or worsen before the next dose of a drug is due and has been reported previously with migraine preventive medications.
DESIGN AND METHODS
This was a long-term, 12-month, multicenter, randomized, double-blind, parallel-group phase 3 study (NCT02638103) that included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients. Patients with CM or EM received fremanezumab either monthly or quarterly. In this post hoc analysis, for selected months, the difference in the average number of migraine days between weeks 1-2 and weeks 3-4, between weeks 1-3 and week 4, and between weeks 1-2 and weeks 11-12 were calculated.
RESULTS
A total of 1890 patients (CM, 1110; EM, 780) were enrolled. At months 3, 6, 9, and 15, there were no substantial differences in mean weekly migraine days between weeks 1-2 and weeks 3-4 or between weeks 1-3 and week 4 with quarterly or monthly fremanezumab in the CM or EM subgroups. There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups. Across both dosing subgroups in CM and EM patients, the mean weekly number of migraine days decreased substantially (30%-42%) during the first 2 weeks; decreases in weekly migraine days remained steady during the last 2 weeks of the first quarter, with a similar maintenance of response during the second quarter.
CONCLUSIONS
This analysis of data from a long-term, phase 3 study showed that patients receiving quarterly fremanezumab or monthly fremanezumab did not experience a wearing-off effect toward the end of the dosing interval.",2020,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"['1890 patients (CM, 1110; EM, 780 ) were enrolled', 'included chronic (CM) and episodic migraine (EM) patients who rolled over from the 12-week Phase 3 HALO CM (NCT02621931) and EM trials (NCT02629861), as well as an additional subset of 312 new patients']","['Fremanezumab', 'fremanezumab']","['mean weekly number of migraine days', 'average number of migraine days', 'mean weekly migraine days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0543436', 'cui_str': 'Does roll over'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",1890.0,0.0446177,There were no substantial increases in mean weekly migraine days between weeks 1-2 and weeks 11-12 during the first quarter of treatment (months 1-3) or the second quarter of treatment (months 4-6) with quarterly or monthly fremanezumab in the CM or EM subgroups.,"[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Blumenfeld', 'Affiliation': 'The Headache Center of Southern California, The Neurology Center, Carlsbad, CA, USA.'}, {'ForeName': 'Darko M', 'Initials': 'DM', 'LastName': 'Stevanovic', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ortega', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Seminerio', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Department of Neurology, Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}]",Headache,['10.1111/head.13994']
2066,33010491,The incidence of persistent postoperative opioid use among U.S. veterans: A national study to identify risk factors.,"OBJECTIVE
To calculate the incidence and identify the predictors of persistent postoperative opioid use at different postoperative days.
BACKGROUND DATA
A subset of surgical patients continues to use long-term opioids. The importance of the risk factors at different postoperative days is not known.
DESIGN
A historical cohort.
SETTING
Postoperative period.
PATIENTS
Opioid-naive U.S. veterans.
INTERVENTIONS
The surgical group had any one of 19 common invasive procedures. The control group is a 10% random sample. Each control was randomly assigned a surgery date.
MEASUREMENTS
The outcomes were the presence of persistent opioid use as determined by continued filling of prescriptions for opioids on postoperative days 90, 180, 270, and 365.
MAIN RESULTS
A total of 183,430 distinct surgical cases and 1,318,894 controls were identified. 1.0% of the surgical patients were using opioids at 90 days, 0.6% at 180 days, 0.4% at 270 days, and 0.1% at 365 days after the surgery. Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls. In risk factor analysis, being male and single were associated with persistent opioid use at earlier time points (90 and 180 days), while hepatitis C and preoperative benzodiazepine use were associated with persistent opioid use at later time points (270 and 365 days).
CONCLUSIONS
Many surgeries or invasive procedures are associated with an increased risk of persistent postoperative opioid use. The postoperative period is dynamic and the risk factors change with time.",2020,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","['Opioid-naive U.S. veterans', 'U.S. veterans', '183,430 distinct surgical cases and 1,318,894 controls were identified']",[],['postoperative persistent opioid use'],"[{'cui': 'C1739422', 'cui_str': 'Opioid naive'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]",[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",183430.0,0.0682083,"Surgery was strongly associated with postoperative persistent opioid use at day 90 (OR 3.67, 95% CI, 3.43-3.94, p < 0.001), at day 180 (OR 2.85, 2.67-3.12, p < 0.001), at day 270 (OR 2.63, 2.38-2.91, p < 0.001) and at day 365 (OR 2.11, 1.77-2.51, p < 0.001) compared to non-surgical controls.","[{'ForeName': 'Khodadad', 'Initials': 'K', 'LastName': 'Namiranian', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Department of Anesthesiology, University of Maryland, Baltimore, MD, United States of America; VA Central California Health Care System, Fresno, CA, United States of America. Electronic address: khodadad.x.namiranian@kp.org.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Siglin', 'Affiliation': 'School of Medicine, University of Maryland, Baltimore, MD, United States of America.'}, {'ForeName': 'John David', 'Initials': 'JD', 'LastName': 'Sorkin', 'Affiliation': 'VA Maryland Health Care System, Baltimore, MD, United States of America; Baltimore VA Medical Center Geriatric Research, Education and Clinical Center, VA Maryland Health Care System, Baltimore, MD, United States of America; Division of Gerontology and Geriatric Medicine, University of Maryland, Baltimore, MD, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110079']
2067,33011188,The influence of linguistic information on cortical tracking of words.,"Speech is a complex sound sequence that has rich acoustic and linguistic structures. Recent studies have suggested that low-frequency cortical activity can track linguistic units in speech, such as words and phrases, on top of low-level acoustic features. Here, with an artificial word learning paradigm, we investigate how different aspects of linguistic information, e.g., phonological, semantic, and orthographic information, modulate cortical tracking of words. Participants are randomly assigned to the experimental group or the control group. Both groups listen to speech streams composed of trisyllabic artificial words or trisyllabic real words. Participants in the experimental group explicitly learn different types of linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words. Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words. However, when comparing the experimental and control groups, we find that explicit learning significantly improves neural tracking of artificial words. After explicit learning, cortical tracking of artificial words is comparable to real words, regardless of the training conditions. These results suggest training facilitates neural tracking of words and emphasize the basic role phonological information played in sequential grouping.",2020,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,[],"['linguistic information of artificial words (phonological, phonological + semantic, or phonological + orthographic information), while participants in the control group do not explicitly learn the words', 'explicit learning']",['neural tracking of artificial words'],[],"[{'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",,0.0216826,Electroencephalographic (EEG) data from the control group reveal weaker cortical tracking of artificial words than real words.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China.'}, {'ForeName': 'Nai', 'Initials': 'N', 'LastName': 'Ding', 'Affiliation': 'Key Laboratory for Biomedical Engineering of Ministry of Education, College of Biomedical Engineering and Instrument Sciences, Zhejiang University, Hangzhou, 310027, China; Research Center for Advanced Artificial Intelligence Theory, Zhejiang Lab, Hangzhou, 311121, China. Electronic address: ding_nai@zju.edu.cn.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107640']
2068,33011864,24-Hour Serial Spirometric Assessment of Once-Daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-Daily Budesonide/Formoterol in Patients with COPD: Analysis of the FULFIL Study.,"INTRODUCTION
Few studies have utilized 24-h serial spirometry to compare the effects of inhaled chronic obstructive pulmonary disease (COPD) therapies on lung function. The FULFIL study previously reported significant lung function improvements with once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus twice-daily single-inhaler budesonide/formoterol (BUD/FOR) in patients with symptomatic COPD at risk of exacerbations.
METHODS
This prespecified analysis evaluated 24-h serial spirometry data from a subgroup of 406 patients in FULFIL. BUD/FOR twice-daily dosing was maintained during 24-h spirometry. A post hoc analysis evaluated serial forced expiratory volume in 1 s (FEV 1 ) at day 1 and week 24 by disease severity at screening (FEV 1 < 50% predicted and no moderate or severe exacerbation in prior year, FEV 1 < 50% predicted and ≥ 1 moderate or severe exacerbation in prior year, and FEV 1 ≥ 50% and < 80% predicted and ≥ 2 moderate or ≥ 1 severe exacerbations in prior year).
RESULTS
Odds of achieving a ≥ 100-mL increase from baseline in FEV 1 within the first 6 h post dose on day 1 were significantly greater with FF/UMEC/VI than BUD/FOR [odds ratio 2.79 (95% confidence interval 1.56-4.98); p < 0.001]. FF/UMEC/VI led to greater improvements in weighted mean FEV 1 over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL; all p < 0.001). Significant between-treatment differences in FEV 1 and forced vital capacity (FVC) in favor of FF/UMEC/VI versus BUD/FOR were seen at all time points at week 24 (FEV 1 range 156-231 mL, all p < 0.001; FVC range 139-309 mL, all p ≤ 0.002). Serial FEV 1 results were consistent irrespective of disease severity at screening.
CONCLUSION
These findings further demonstrate sustained lung function benefits with once-daily FF/UMEC/VI single-inhaler triple therapy in patients with symptomatic COPD at risk of exacerbations across a range of disease severities.",2020,"FF/UMEC/VI led to greater improvements in weighted mean FEV 1 over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL;","['Patients with COPD', '406 patients in FULFIL', 'patients with symptomatic COPD at risk of exacerbations across a range of disease severities', 'patients with symptomatic COPD at risk of exacerbations']","['fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus twice-daily single-inhaler budesonide/formoterol (BUD/FOR', 'Fluticasone Furoate/Umeclidinium/Vilanterol', 'Budesonide/Formoterol']","['serial forced expiratory volume', 'FEV 1 and forced vital capacity (FVC) in favor of FF/UMEC/VI versus BUD/FOR', '24-Hour Serial Spirometric Assessment', 'severe exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",406.0,0.336625,"FF/UMEC/VI led to greater improvements in weighted mean FEV 1 over 0-6, 0-12, 0-24, and 12-24 h on day 1 and at week 24, with the greatest between-group differences at week 24 (range 196-210 mL;","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, 1250 S Collegeville Rd, Collegeville, PA, 19426, USA. david.a.lipson@gsk.com.'}, {'ForeName': 'Ruby', 'Initials': 'R', 'LastName': 'Birk', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}, {'ForeName': 'Noushin', 'Initials': 'N', 'LastName': 'Brealey', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Zhu', 'Affiliation': 'GSK, Stockley Park West, Iron Bridge Rd N, West Drayton, Uxbridge, UB11 1BT, UK.'}]",Advances in therapy,['10.1007/s12325-020-01496-7']
2069,32962980,A Prognostic Model Based on PAM50 and Clinical Variables (PAM50MET) for Metastatic Hormone Receptor-positive HER2-negative Breast Cancer.,"PURPOSE
Predicting prognosis in HR + /HER2 - metastatic breast cancer (MBC) might be clinically useful; however, no validated prognostic biomarkers exist in this setting to date.
PATIENTS AND METHODS
In phase III, EGF30008 trial, 484 patients with HER2 - MBC who received letrozole and placebo or lapatinib were selected. PAM50 data, ECOG performance status, visceral disease, number of metastasis, biopsy type, and age were evaluated. A progression-free survival (PFS) Cox model was evaluated. The final model (PAM50MET) with a prespecified cutoff was validated in patients ( n = 261) with HR + /HER2 - advanced breast cancer (aBC) from BOLERO-2 (phase III trial that evaluated exemestane and placebo or everolimus).
RESULTS
In EGF30008, prognostic models with PAM50 plus clinical variables yielded higher C-index values versus models with only PAM50 or clinical variables. The PAM50MET model combined 21 variables: 2 PAM50 subtypes, basal signature, 14 genes, and 4 clinical variables. In EGF30008, the optimized cutoff was associated with PFS [HR = 0.37; 95% confidence interval (CI), 0.29-0.47; P < 0.0001] and overall survival (OS; HR = 0.37; 95% CI, 0.27-0.51; P < 0.0001). The median (months; 95% CI) PFS and OS were 22.24 (19.0-24.9) and not reached in PAM50MET-low versus 9.13 (8.15-11.0) and 33.0 (28.0-40.0) in PAM50MET-high groups, respectively. In BOLERO-2, the PAM50MET-low was associated with better PFS (HR = 0.72; 95% CI, 0.53-0.96; P = 0.028) and OS (HR = 0.51; 95% CI, 0.35-0.69; P < 0.0001). The median (months) (95% CI) PFS and OS were 6.93 (5.57-11.0) and 36.9 (33.4-NA) in PAM50MET-low versus 5.23 (4.2-6.8) and 23.5 (20.2-28.3) in PAM50MET-high groups, respectively.
CONCLUSIONS
PAM50MET is prognostic in HR + /HER2 - MBC, and further evaluation might help identify candidates for endocrine therapy only or novel therapies.",2020,"In BOLERO-2, the PAM50MET-low was associated with better PFS (HR=0.72; 95% CI 0.53-0.96; P =0.028) and OS (HR=0.51; 95% CI 0.35-0.69; P <0.0001).","['patients (n=261) with HR+/HER2-negative aBC from BOLERO-2', '484 patients with HER2-negative MBC who received']","['exemestane and placebo or everolimus', 'letrozole and placebo or lapatinib']","['A progression-free survival (PFS', 'PAM50 data, ECOG PS, visceral disease, number of metastasis, biopsy type, and age', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0152244', 'cui_str': 'Aneurysmal bone cyst'}, {'cui': 'C0244436', 'cui_str': 'Bolero'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0065839', 'cui_str': 'Carbendazim'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449798', 'cui_str': 'Number of metastases'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",484.0,0.0728994,"In BOLERO-2, the PAM50MET-low was associated with better PFS (HR=0.72; 95% CI 0.53-0.96; P =0.028) and OS (HR=0.51; 95% CI 0.35-0.69; P <0.0001).","[{'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain. alprat@clinic.cat parkerjs@email.unc.edu.'}, {'ForeName': 'Yi-Hsuan', 'Initials': 'YH', 'LastName': 'Tsai', 'Affiliation': 'Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Paré', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Adamo', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Fara', 'Initials': 'F', 'LastName': 'Brasó-Maristany', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Galván', 'Affiliation': 'Department of Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jan Christoph', 'Initials': 'JC', 'LastName': 'Brase', 'Affiliation': 'Novartis Oncology, Basel, Switzerland.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rodrik-Outmezguine', 'Affiliation': 'Novartis Pharmaceutical Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Johnston', 'Affiliation': 'Department of Medical Oncology, Royal Marsden Hospital, London, England.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Cooperative Group, Barcelona, Spain.'}, {'ForeName': 'Joel S', 'Initials': 'JS', 'LastName': 'Parker', 'Affiliation': 'Department of Genetics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. alprat@clinic.cat parkerjs@email.unc.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2793']
2070,32966120,Aging reduces the maximal level of peripheral fatigue tolerable and impairs exercise capacity.,"The aim of the present study was to determine the magnitude of the maximal level of peripheral fatigue attainable (fatigue threshold) during an all-out intermittent isometric knee-extensor protocol in both younger (24 ± 1 yr, n = 12) and older (60 ± 2 yr, n = 12) participants to provide new insights into the effects of aging on neuromuscular function. Participants performed two experimental sessions, in which they performed 60 maximal voluntary contractions (MVCs; 3 s of contraction, 2 s of relaxation). One trial was performed in the unfatigued state (CTRL) and one other following fatiguing neuromuscular electrical stimulation of the quadriceps (F NMES ). Peripheral fatigue was quantified via pre/postexercise decrease in quadriceps twitch force (∆P tw ). Critical force (CF) was determined as the mean force output of the last 12 contractions, whereas W ' was calculated as the area above CF. Although F NMES led to a significant decrease in P tw before performing the 60-MVCs protocol ( P = 0.024), ∆P tw was not different between CTRL and F NMES for both the young group ( P = 0.491) and the old group ( P = 0.523). However, this peripheral fatigue threshold was significantly greater in young versus old participants (∆P tw = -48 ± 10% vs. -29 ± 13%, respectively, P = 0.028). In CTRL, W' was 55 ± 13% lower in the old group than in the young group ( P < 0.001), but CF was similar (326 ± 10 N vs. 322 ± 12 N, respectively, P = 0.941). ∆P tw was correlated with W' , independently of age ( r 2 = 0.84, P < 0.001). Exercise performance decreases with aging consequent to a lower tolerance to peripheral fatigue. However, the peripheral fatigue threshold mechanism persists with healthy aging and continues to play a protective role in preserving locomotor muscle function during exercise.",2020,"While F NMES led to significant decrease in P tw prior to performing the 60 MVCs protocol (P<0.05), ∆P tw was not different between CTRL and F NMES for both the young (P=0.49) and the old (P=0.52) group.","['both young (24±1years, N=12) and older participants (60±2years, N=12']",['peripheral fatigue attainable (fatigue threshold) during all-out intermittent isometric knee-extensor protocol'],"['Critical force (CF', 'Peripheral fatigue', 'maximal level of peripheral fatigue tolerable and impairs exercise capacity', 'peripheral fatigue threshold', 'quadriceps twitch-force (∆P tw ']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}]",60.0,0.0251441,"While F NMES led to significant decrease in P tw prior to performing the 60 MVCs protocol (P<0.05), ∆P tw was not different between CTRL and F NMES for both the young (P=0.49) and the old (P=0.52) group.","[{'ForeName': 'Slim', 'Initials': 'S', 'LastName': 'Zarzissi', 'Affiliation': 'Education, Motor Skills, Sport and Health Laboratory, High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'Education, Motor Skills, Sport and Health Laboratory, High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Zghal', 'Affiliation': 'Education, Motor Skills, Sport and Health Laboratory, High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'Education, Motor Skills, Sport and Health Laboratory, High Institute of Sport and Physical Education, University of Sfax, Sfax, Tunisia.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hureau', 'Affiliation': 'Mitochondria, Oxidative Stress and Muscular Protection Laboratory (UR 3072), Faculty of Medicine, University of Strasbourg, Strasbourg, France.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00151.2020']
2071,32966123,Effects of L-type voltage-gated Ca 2+ channel blockade on cholinergic and thermal sweating in habitually trained and untrained men.,"We evaluated the hypothesis that the activation of L-type voltage-gated Ca 2+ channels contributes to exercise training-induced augmentation in cholinergic sweating. On separate days, 10 habitually trained and 10 untrained men participated in two experimental protocols. Prior to each protocol, we administered 1% verapamil (Verapamil, L-type voltage-gated Ca 2+ channel blocker) and saline (Control) at forearm skin sites on both arms via transdermal iontophoresis. In protocol 1 , we administered low (0.001%) and high (1%) doses of pilocarpine at both the verapamil-treated and verapamil-untreated forearm sites. In protocol 2 , participants were passively heated by immersing their limbs in hot water (43°C) until rectal temperature increased by 1.0°C above baseline resting levels. Sweat rate at all forearm sites was continuously measured throughout both protocols. Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both the concentrations of pilocarpine (both P ≤ 0.001). Pilocarpine-induced sweating at the low-dose site was attenuated at the Verapamil versus the Control site in both the groups (both P ≤ 0.004), albeit the reduction was greater in trained as compared with in untrained men ( P = 0.005). The verapamil-mediated reduction in sweating remained intact at the high-dose pilocarpine site in the untrained men ( P = 0.004) but not the trained men ( P = 0.180). Sweating did not differ between Control and Verapamil sites with increases in rectal temperature in both groups (interaction, P = 0.571). We show that activation of L-type voltage-gated Ca 2+ channels modulates sweat production in habitually trained men induced by a low dose of pilocarpine. However, no effect on sweating was observed during passive heating in either group.",2020,Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both concentrations of pilocarpine (both P≤0.001).,"['habitually trained men', '10 habitually trained and 10 untrained men participated in two experimental protocols', 'habitually trained and untrained men']","['verapamil-treated and untreated forearm sites', 'Pilocarpine', 'verapamil (Verapamil, L-type voltage-gated Ca 2+ channel blocker) and saline (Control', 'L-type voltage-gated Ca 2+ channel blockade', 'Verapamil', 'pilocarpine', 'verapamil']","['sweating in Control', 'sweating', 'rectal temperature', 'Sweating', 'cholinergic and thermal sweating', 'Sweat rate']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0596235', 'cui_str': 'Calcium ion'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0242893', 'cui_str': 'Acetylcholine Agents'}]",,0.0322647,Pilocarpine-induced sweating in Control was higher in trained than in untrained men for both concentrations of pilocarpine (both P≤0.001).,"[{'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Amano', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba City, Japan.'}, {'ForeName': 'Glen P', 'Initials': 'GP', 'LastName': 'Kenny', 'Affiliation': 'Human and Environmental Physiology Research Unit, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Okamoto', 'Affiliation': 'Laboratory for Exercise and Environmental Physiology, Faculty of Education, Niigata University, Niigata, Japan.'}, {'ForeName': 'Yoshimitsu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Laboratory for Human Performance Research, Osaka International University, Osaka, Japan.'}, {'ForeName': 'Narihiko', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Laboratory for Applied Human Physiology, Graduate School of Human Development and Environment, Kobe University, Kobe, Japan.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00167.2020']
2072,32977137,Therapeutic versus prophylactic anticoagulation for severe COVID-19: A randomized phase II clinical trial (HESACOVID).,"INTRODUCTION
Coronavirus disease 2019 (COVID-19) causes a hypercoagulable state. Several autopsy studies have found microthrombi in pulmonary circulation.
METHODS
In this randomized, open-label, phase II study, we randomized COVID-19 patients requiring mechanical ventilation to receive either therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis. We evaluated the gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, 7, and 14 days after randomization, the time until successful liberation from mechanical ventilation, and the ventilator-free days.
RESULTS
Ten patients were assigned to the therapeutic enoxaparin and ten patients to prophylactic anticoagulation. There was a statistically significant increase in the PaO2/FiO2 ratio over time in the therapeutic group (163 [95% confidence interval - CI 133-193] at baseline, 209 [95% CI 171-247] after 7 days, and 261 [95% CI 230-293] after 14 days), p = 0.0004. In contrast, we did not observe this improvement over time in the prophylactic group (184 [95% CI 146-222] at baseline, 168 [95% CI 142-195] after 7 days, and 195 [95% CI 128-262] after 14 days), p = 0.487. Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = 0.031 and more ventilator-free days (15 days [interquartile range IQR 6-16] versus 0 days [IQR 0-11]), p = 0.028 when compared to the prophylactic group.
CONCLUSION
Therapeutic enoxaparin improves gas exchange and decreases the need for mechanical ventilation in severe COVID-19.
TRIAL REGISTRATION
REBEC RBR-949z6v.",2020,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","['COVID-19 patients requiring mechanical ventilation to receive either', 'severe COVID-19']","['Therapeutic versus prophylactic anticoagulation', 'enoxaparin', 'prophylactic anticoagulation', 'therapeutic enoxaparin', 'therapeutic enoxaparin or the standard anticoagulant thromboprophylaxis']","['PaO2/FiO2 ratio', 'higher ratio of successful liberation from mechanical ventilation', 'gas exchange over time through the ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",10.0,0.230806,"Patients of the therapeutic group had a higher ratio of successful liberation from mechanical ventilation (hazard ratio: 4.0 [95% CI 1.035-15.053]), p = ","[{'ForeName': 'Anna Cristina Bertoldi', 'Initials': 'ACB', 'LastName': 'Lemos', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Douglas Alexandre', 'Initials': 'DA', 'LastName': 'do Espírito Santo', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Maísa Cabetti', 'Initials': 'MC', 'LastName': 'Salvetti', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Renato Noffs', 'Initials': 'RN', 'LastName': 'Gilio', 'Affiliation': 'Hospital Estadual de Américo Brasiliense, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Lucas Barbosa', 'Initials': 'LB', 'LastName': 'Agra', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pazin-Filho', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Carlos Henrique', 'Initials': 'CH', 'LastName': 'Miranda', 'Affiliation': 'Division of Emergency Medicine, Department of Internal Medicine, Ribeirão Preto School of Medicine, São Paulo University, Ribeirão Preto, SP, Brazil. Electronic address: chmiranda@fmrp.usp.br.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.026']
2073,32978722,A Phase I Placebo-Controlled Trial Comparing the Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride Administration on Respiratory Drive.,"INTRODUCTION
Buprenorphine is a partial μ-opioid receptor agonist that, unlike full μ-opioid receptor agonists, has been shown to have a ceiling effect on respiratory depression. Buprenorphine buccal film (BBF) is approved by the US Food and Drug Administration for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for whom alternative treatment options are inadequate. This study was conducted to compare the effects of BBF and immediate-release oral oxycodone hydrochloride administration on respiratory drive, as measured by the ventilatory response to hypercapnia (VRH) after drug administration.
METHODS
Subjects (N = 19) were men and women, ages 27-41 years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test. Respiratory drive was evaluated by measuring VRH through the assessment of the maximum decrease in minute ventilation (E max ) after administration of each treatment. The treatments utilized in this study included 300, 600, and 900 μg BBF; 30 and 60 mg orally administered oxycodone; and placebo (each separated by a 7-day washout period). Effects on respiratory drive were assessed using a double-blind, double-dummy, six-treatment, six-period, placebo-controlled, randomized crossover design. Statistical analyses were performed using a linear mixed-effects model.
RESULTS
The least squares mean differences in minute volume E max (L/min, versus placebo) were as follows: 300 μg BBF (+ 1.24, P = 0.529), 600 μg BBF (+ 0.23, P = 0.908), 900 μg BBF (+ 0.93, P = 0.637), 30 mg oxycodone (- 0.79, P = 0.687), and 60 mg oxycodone (- 5.23, P = 0.010).
CONCLUSIONS
BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg. Administration of oxycodone resulted in a significant dose-dependent decrease in respiratory drive. These data suggest that BBF may be a safer treatment option than full μ-opioid receptor agonists for patients with chronic pain.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT03996694.",2020,"CONCLUSIONS
BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","['300, 600, and 900\xa0μg BBF; 30 and 60\xa0mg orally administered', 'patients with chronic pain severe', 'Subjects (N\u2009=\u200919) were men and women, ages 27-41\xa0years, self-identifying as recreational opioid users who were not physically dependent on opioids as determined via a Naloxone Challenge Test', 'patients with chronic pain']","['Buprenorphine buccal film (BBF', 'oxycodone; and placebo', 'Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride', 'Buprenorphine', 'BBF', 'oxycodone hydrochloride', 'placebo', 'oxycodone', 'Placebo']","['minute ventilation (E max ', 'ventilatory response to hypercapnia (VRH', 'respiratory drive']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C4056633', 'cui_str': 'Buprenorphine Buccal Film [Belbuca]'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",,0.319049,"CONCLUSIONS
BBF did not significantly reduce respiratory drive at any dose compared with placebo, including at the maximum available prescription dose of 900 μg.","[{'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Webster', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA. WebsterLynn@prahs.com.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hansen', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Cater', 'Affiliation': 'PRA Health Sciences, Salt Lake City, UT, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'BioDelivery Sciences International, Inc., Raleigh, NC, USA.'}]",Advances in therapy,['10.1007/s12325-020-01481-0']
2074,33002839,A body-weight-supported visual feedback system for gait recovering in stroke patients: A randomized controlled study.,"OBJECTIVE
The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet.
DESIGN
A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments.
SETTING
Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy).
PARTICIPANTS
63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups.
TREATMENTS
All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group (""control"") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group).
MAIN OUTCOME MEASURES
Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up.
RESULTS
Significant interaction Group*Time effects scales (F 2,126 = 5.1, p-level = 0.005, η² p = 0.25; F 2,126 = 4.7, p-level = 0.007, η² p = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment.
CONCLUSION
The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.",2020,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"['hemiplegic patients', 'Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy', 'gait recovering in stroke patients', '63 first-ever stroke patients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups']","['conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group', 'novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy', 'body-weight-supported visual feedback system']","['Group*Time effects scales', 'gait recovery', 'static balance', 'Functional Independence Measure and Tinetti-Balance scales', 'conventional clinical scales and kinematic measurement of static gait balance', 'recovery of motor functioning']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.0295403,The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.,"[{'ForeName': 'Loris', 'Initials': 'L', 'LastName': 'Pignolo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Basta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Carozzo', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'MariaConcetta', 'Initials': 'M', 'LastName': 'Bilotta', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Todaro', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Serra', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Ciancarelli', 'Affiliation': ""Department of Life, Health and Environmental Sciences, University of L'Aquila, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tonin', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cerasa', 'Affiliation': 'S. Anna Institute, 88900, Crotone, Italy; Institute for Biomedical Research and Innovation, National Research Council, (IRIB-CNR), 87050, Mangone, CS, Italy. Electronic address: antonio.cerasa76@gmail.com.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.020']
2075,33003179,Randomized Clinical Trial of 20% Mannitol Versus 3% Hypertonic Saline in Children With Raised Intracranial Pressure Due to Acute CNS Infections.,"OBJECTIVES
Mannitol is a commonly used osmotherapy agent in raised intracranial pressure. However, the side effects of mannitol are significant. In traumatic brain injury (adult and pediatric), hypertonic saline (3%) shows varied results in comparison with 20% mannitol. We compared the effect of 3% hypertonic saline versus 20% mannitol (using common dosing strategies) on raised intracranial pressure in pediatric acute CNS infections.
DESIGN
Open-label randomized controlled trial.
SETTING
PICU of a quaternary care academic institute.
PATIENTS
Children 1-12 years old, with raised intracranial pressure and modified-Glasgow Coma Scale scores less than or equal to 8, were enrolled.
INTERVENTIONS
Patients were randomly assigned to 20%-mannitol (n = 28), 0.5 gram/kg/dose versus 3%-hypertonic saline (n = 29), 10 mL/kg loading followed by 0.5-1 mL/kg/hr infusion. An intraparenchymal catheter was used to monitor the intracranial pressure. The primary outcome was the proportion of patients achieved target average intracranial pressure less than 20 mm Hg during 72 hours. Secondary outcomes were interventions, morbidity, and mortality.
MEASUREMENTS AND MAIN RESULTS
The proportion of patients with target average intracranial pressure (< 20 mm Hg) was higher in hypertonic saline-group as compared to mannitol-group (79.3% vs 53.6%; adjusted hazard ratio 2.63; 95% CI: 1.23-5.61). Mean (± SE) reduction of intracranial pressure (-14.3 ± 1.7 vs -5.4 ± 1.7 mm Hg; p ≤ 0.001) and elevation of cerebral perfusion pressure (15.4 ± 2.4 vs 6 ± 2.4 mm Hg; p = 0.007) from baseline were significant in hypertonic saline-group. Mean (± SE) intracranial pressure over 72 hours was lower (14 ± 2 vs 22 ± 2 mm Hg; p = 0.009), and cerebral perfusion pressure was higher (65 ± 2.2 vs 58 ± 2.2; p = 0.032) in hypertonic saline-group. Hypertonic saline-group had higher modified-Glasgow Coma Scale score at 72 hours (median, interquartile range 10; 7-11 vs 7; 3-9; p = 0.003), lower mortality (20.7% vs 35.7%; p = 0.21), shorter duration of mechanical ventilation (5 vs 15 d; p = 0.002), and PICU stay (11 vs 19 d; p = 0.016) and less severe neurodisability at discharge (31% vs 61%; p = 0.049).
CONCLUSIONS
In pediatric acute CNS infections, 3%-hypertonic saline was associated with a greater reduction of intracranial pressure as compared to 20% mannitol.",2020,The proportion of patients with target average intracranial pressure (< 20 mm Hg) was higher in hypertonic saline-group as compared to mannitol-group (79.3% vs 53.6%; adjusted hazard ratio 2.63; 95% CI: 1.23-5.61).,"['Children With Raised Intracranial Pressure', 'pediatric acute CNS infections', 'Children 1-12 years old, with raised intracranial pressure and modified-Glasgow Coma Scale scores less than or equal to 8, were enrolled', 'PICU of a quaternary care academic institute']","['3%-hypertonic saline', 'Mannitol Versus 3% Hypertonic Saline', 'hypertonic saline versus 20% mannitol', 'Hypertonic saline', 'hypertonic saline']","['Mean (± SE) intracranial pressure', 'severe neurodisability at discharge', 'lower mortality', 'interventions, morbidity, and mortality', 'shorter duration of mechanical ventilation', 'proportion of patients achieved target average intracranial pressure less', 'modified-Glasgow Coma Scale score', 'Mean (± SE) reduction of intracranial pressure', 'elevation of cerebral perfusion pressure', 'proportion of patients with target average intracranial pressure', 'cerebral perfusion pressure', 'PICU stay', 'intracranial pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0151740', 'cui_str': 'Raised intracranial pressure'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007684', 'cui_str': 'Infectious disease of central nervous system'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4302653', 'cui_str': 'Neurodisability'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0428713', 'cui_str': 'Cerebral perfusion pressure'}, {'cui': 'C1046445', 'cui_str': 'Picus'}]",,0.324327,The proportion of patients with target average intracranial pressure (< 20 mm Hg) was higher in hypertonic saline-group as compared to mannitol-group (79.3% vs 53.6%; adjusted hazard ratio 2.63; 95% CI: 1.23-5.61).,"[{'ForeName': 'Ramachandran', 'Initials': 'R', 'LastName': 'Rameshkumar', 'Affiliation': 'All authors: Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': ''}, {'ForeName': 'Sunit', 'Initials': 'S', 'LastName': 'Singhi', 'Affiliation': ''}, {'ForeName': 'Pratibha', 'Initials': 'P', 'LastName': 'Singhi', 'Affiliation': ''}, {'ForeName': 'Muralidharan', 'Initials': 'M', 'LastName': 'Jayashree', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002557']
2076,33006120,Accelerated and Standard Corneal Cross-Linking Protocols in Patients with Down Syndrome: A Non-inferiority Contralateral Randomized Trial.,"INTRODUCTION
To compare the results of an accelerated corneal cross-linking (CXL) protocol (9 mW/cm 2 , 10 min) with the standard CXL protocol (3 mW/cm 2 , 30 min) in patients with Down syndrome (DS) who have keratoconus (KC).
METHODS
Twenty-seven 10- to 20-year-old patients with DS who had bilateral progressive KC were enrolled in a contralateral randomized trial and completed 2 years of follow-up examinations. Fellow eyes were randomly allocated to the accelerated CXL group or the standard CXL group. The main outcome measure was change in maximum keratometry (K max ) centered on the steepest point (zonal K max - 3 mm) with a non-inferiority margin of 1.0 diopter (D). Vision and refraction tests, ophthalmic examinations, and corneal tomography were performed at baseline and at 6, 12, and 24 months after CXL. Failure was defined as an increase of ≥ 1.0 D in zonal K max - 3 mm within a 12-month period.
RESULTS
The mean age (± standard deviation) of the patients was 15.71 ± 2.40 years. The within-group change in zonal K max - 3 mm was not significant after 2 years in either group, and within-group zonal K max - 3 mm remained stable. At 2 years after CXL, the mean change in the zonal K max - 3 mm was - 0.02 ± 0.81 D and - 0.31 ± 0.86 D in the accelerated CXL and standard CXL groups, respectively (P = 0.088). At 1 year of follow-up, three patients in the accelerated CXL group showed treatment failure (mean change in zonal K max - 3 mm + 2.12 ± 0.11 D); no patients in the standard CXL group showed treatment failure. At 2 years of follow-up, these three patients showed a decrease of - 0.43 ± 0.18 D in zonal K max - 3 mm from a baseline value of 55.11 ± 0.32 D. The 2-year trends of the inferior-superior asymmetry and vertical coma were statistically significantly different between the two groups, with the accelerated CXL protocol showing superiority in patients with higher baseline values.
CONCLUSION
In young patients with Down syndrome, the accelerated CXL protocol was able to halt disease progression and may be an alternative for the standard CXL protocol. In advanced KC, the efficacy of the accelerated approach was delayed and appeared later in the follow-up. In asymmetric cornea, the accelerated CXL resulted in centralization of the corneal cone.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials, IRCT20100706004333N3.",2020,"The within-group change in zonal K max - 3 mm was not significant after 2 years in either group, and within-group zonal K max - ","['Fellow eyes', 'patients with Down syndrome (DS) who have keratoconus (KC', 'young patients with Down syndrome', 'The mean age (± standard deviation) of the patients was 15.71\u2009±\u20092.40\xa0years', 'Patients with Down Syndrome', 'Twenty-seven 10- to 20-year-old patients with DS who had bilateral progressive KC']","['accelerated corneal cross-linking (CXL) protocol (9 mW/cm 2 , 10\xa0min) with the standard CXL protocol', 'Accelerated and Standard Corneal Cross-Linking Protocols', 'accelerated CXL group or the standard CXL']","['treatment failure', 'change in maximum keratometry (K max ) centered on the steepest point (zonal K max -\xa03\xa0mm) with a non-inferiority margin of 1.0 diopter (D', 'Vision and refraction tests, ophthalmic examinations, and corneal tomography', 'zonal K max', '2-year trends of the inferior-superior asymmetry and vertical coma']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1564799', 'cui_str': 'Zonal'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0009421', 'cui_str': 'Coma'}]",,0.0809079,"The within-group change in zonal K max - 3 mm was not significant after 2 years in either group, and within-group zonal K max - ","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hashemi', 'Affiliation': 'Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran.'}, {'ForeName': 'Kazem', 'Initials': 'K', 'LastName': 'Amanzadeh', 'Affiliation': 'Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Seyedian', 'Affiliation': 'Noor Research Center for Ophthalmic Epidemiology, Noor Eye Hospital, Tehran, Iran.'}, {'ForeName': 'Hojjat', 'Initials': 'H', 'LastName': 'Zeraati', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Roberts', 'Affiliation': 'Department of Ophthalmology and Visual Science, The Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Mehravaran', 'Affiliation': 'ASCEND Center for Biomedical Research, Morgan State University, Baltimore, MD, USA.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Ambrósio', 'Affiliation': 'Rio de Janeiro Corneal Tomography and Biomechanics Study Group, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vinciguerra', 'Affiliation': 'Humanitas Sant Pio X Hospital, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Vinciguerra', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran. soheilaasgari@gmail.com.'}]",Ophthalmology and therapy,['10.1007/s40123-020-00303-4']
2077,33007709,Non-invasive ventilation improves exercise tolerance and peripheral vascular function after high-intensity exercise in COPD-HF patients.,"AIM
Evaluate the acute effects of non-invasive positive pressure ventilation (NiPPV) during high-intensity exercise on endothelial function in patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF).
METHODS
This is a randomized, double blinded, sham-controlled study involving 14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography. On two different days, patients performed incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV (bilevel mode - Astral 150) in a random order until the limit of tolerance (Tlim). Endothelial function was evaluated by flow mediated vasodilation (FMD) at three time points: 1) Baseline; 2) immediately post-exercise with NiPPV; and 3) immediately post-exercise with Sham.
RESULTS
Our patients had a mean age of 70 ± 7 years, FEV 1 1.9 ± 0.7 L and LVEF 41 ± 9%. NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s p = 0.015) and SpO 2 (NiPPV: 94.7 ± 3.5% vs Sham: 92.7 ± 5.2% p = 0.03). Also, NiPPV was able to produce a significant increase in FMD (%) (NiPPV: 9.2 ± 3.1 vs Sham: 3.6 ± 0.7, p < 0.05), FMD (mm) (NiPPV: 0.41 ± 0.18 vs Sham: 0.20 ± 0.11, p < 0.05), Blood flow velocity (NiPPV: 33 ± 18 vs Baseline: 20 ± 14, p < 0.05) and Shear Stress (SS) (NiPPV: 72 ± 38 vs Baseline: 43 ± 25, p < 0.05). We found correlation between Tlim vs. ΔSS (p = 0.03; r = 0.57). Univariate-regression analysis revealed that increased SS influenced 32% of Tlim during exercise with NiPPV.
CONCLUSION
NiPPV applied during high-intensity exercise can acutely modulate endothelial function and improve exercise tolerance in COPD-HF patients. In addition, the increase of SS positively influences exercise tolerance.",2020,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"['patients with coexisting chronic obstructive pulmonary disease (COPD) and heart failure (HF', 'Our patients had a mean age of 70\xa0±\xa07 years, FEV 1', '14 COPD-HF patients, who underwent a lung function test and Doppler echocardiography', 'COPD-HF patients']","['non-invasive positive pressure ventilation (NiPPV', 'NIPPV', 'high-intensity exercise', 'incremental cardiopulmonary exercise testing (CPET) and two constant-work rate tests (80% of CPET peak) receiving Sham or NiPPV', 'NiPPV']","['Shear Stress (SS) ', 'SS positively influences exercise tolerance', 'Blood flow velocity', 'FMD', 'Endothelial function', 'exercise tolerance and peripheral vascular function', 'exercise tolerance', 'endothelial function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0055954', 'cui_str': 'Clostridium perfringens epsilon toxin'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0005798', 'cui_str': 'Blood Flow Velocity'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",14.0,0.444389,NIPPV resulted in an increased Tlim (NiPPV: 130 ± 29s vs Sham: 98 ± 29s,"[{'ForeName': 'Cássia', 'Initials': 'C', 'LastName': 'da Luz Goulart', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: Luz.cassia@hotmail.com.'}, {'ForeName': 'Flávia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: fla.rossi@hotmail.com.'}, {'ForeName': 'Adriana S', 'Initials': 'AS', 'LastName': 'Garcia de Araújo', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: garciadrica@hotmail.com.'}, {'ForeName': 'Guilherme Peixoto', 'Initials': 'GP', 'LastName': 'Tinoco Arêas', 'Affiliation': 'Human Physiology Laboratory, Physiology Department, Federal University of Amazonas, UFAM, Manaus, AM, Brazil. Electronic address: Guilhermepta@hotmail.com.'}, {'ForeName': 'Sílvia Cristina', 'Initials': 'SC', 'LastName': 'Garcia de Moura', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: silvinhacgmoura@gmail.com.'}, {'ForeName': 'Aparecida Maria', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physiotherapy Department, Federal University of São Carlos, Rod Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: amcatai50@gmail.com.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: mendesrg@hotmail.com.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: shanep@uic.edu.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Department of Physical Therapy, Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago (UIC), Chicago, IL, USA. Electronic address: rarena70@gmail.com.'}, {'ForeName': 'Andréa Lúcia', 'Initials': 'AL', 'LastName': 'Gonçalves da Silva', 'Affiliation': 'Department of Physical Education and Health, University of Santa Cruz do Sul, Rio Grande do Sul, Brazil. Electronic address: andreag@unisc.br.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Physiotherapy Department, Federal University of Sao Carlos, UFSCar, Rodovia Washington Luis, KM 235, Monjolinho, CEP: 13565-905, Sao Carlos, SP, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106173']
2078,33008770,"No effect of a low dose of metformin on the lipid profile, body mass index and weight gain in pregnant women with obesity: A randomized trial.","OBJECTIVE
Evaluate the lipid profile, Body Mass Index (BMI) and weight gain of pregnant women with obesity and the effect of a low dose (1000 mg/day) of metformin hydrochloride on these parameters.
METHODS
A randomized clinical trial was performed from October 31th, 2014 to January 25th, 2018 with pregnant women diagnosed with obesity by arrival BMI ≥ 30.0 kg/m 2 . The participants were randomized into two groups: metformin and control. All pregnant women received standard prenatal follow-up and the same instructions of diet and physical exercise. Laboratory tests were performed at three different times: first moment with gestational age (GA) < 20 weeks, second (GA 24-28 weeks) and third (GA 32-34 weeks) measuring maternal serum levels of total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides (TG) as well as weight gain and BMI were monitored.
RESULTS
A total of 424 pregnant women with obesity were evaluated. Of these, 218 (51.41%) composed the control group and 206 (48.59%) the metformin group. There was no difference of lipid profile, BMI and weight gain values between groups during the 1st, 2nd and 3rd evaluation moments. A significant difference was observed, only in the BMI, HDL and TG values from 1st to 3rd evaluation moments.
CONCLUSION
Low dose (1000 mg/day) of the drug showed no effect on the lipid profile, BMI and weight gain in pregnant women with obesity in metformin group during the evaluation moments.",2020,"There was no difference of lipid profile, BMI and weight gain values between groups during the 1st, 2nd and 3rd evaluation moments.","['pregnant women with obesity', 'pregnant women with obesity in', '424 pregnant women with obesity', 'October 31th, 2014 to January 25th, 2018 with pregnant women diagnosed with obesity by arrival BMI\u202f≥\u202f30.0\u202fkg/m 2 ', 'All pregnant women received']","['standard prenatal follow-up and the same instructions of diet and physical exercise', 'metformin and control', 'metformin', 'metformin hydrochloride']","['BMI, HDL and TG values', 'lipid profile, BMI and weight gain values', 'maternal serum levels of total cholesterol (TC), low density lipoprotein (LDL), high density lipoprotein (HDL) and triglycerides (TG) as well as weight gain and BMI', 'lipid profile, body mass index and weight gain', 'lipid profile, Body Mass Index (BMI) and weight gain', 'lipid profile, BMI and weight gain']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",424.0,0.0612263,"There was no difference of lipid profile, BMI and weight gain values between groups during the 1st, 2nd and 3rd evaluation moments.","[{'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Dienstmann', 'Affiliation': 'University of the Region of Joinville - UNIVILLE, Joinville, SC, Brazil. Electronic address: guidbio@gmail.com.'}, {'ForeName': 'Iramar Baptistella do', 'Initials': 'IBD', 'LastName': 'Nascimento', 'Affiliation': 'University of the Region of Joinville - UNIVILLE, Joinville, SC, Brazil. Electronic address: iramar.nascimento@udesc.br.'}, {'ForeName': 'Willian Barbosa', 'Initials': 'WB', 'LastName': 'Sales', 'Affiliation': 'University of the Region of Joinville - UNIVILLE, Joinville, SC, Brazil. Electronic address: willianbarbosasales@gmail.com.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Leite Ramos de Souza', 'Affiliation': 'University of the Region of Joinville - UNIVILLE, Joinville, SC, Brazil. Electronic address: matheus.leite.souza@gmail.com.'}, {'ForeName': 'Grazielle Dutra da', 'Initials': 'GDD', 'LastName': 'Silva', 'Affiliation': 'University of the Region of Joinville - UNIVILLE, Joinville, SC, Brazil. Electronic address: gra_dutra@hotmail.com.'}, {'ForeName': 'Larissa Cano', 'Initials': 'LC', 'LastName': 'de Oliveira', 'Affiliation': 'University of the Region of Joinville - UNIVILLE, Joinville, SC, Brazil. Electronic address: laricdo@gmail.com.'}, {'ForeName': 'Jean Carl', 'Initials': 'JC', 'LastName': 'Silva', 'Affiliation': 'University of the Region of Joinville - UNIVILLE, Joinville, SC, Brazil. Electronic address: jeancarlsilva@gmail.com.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.09.005']
2079,33009066,Intrarectal Electromotive Botulinum Toxin Type A Administration in Children With Intractable Constipation: A Randomized Clinical Trial.,"INTRODUCTION
Children with refractory constipation might not respond to conventional medical treatments. In this study, we assessed the effectiveness of intrarectal botulinum toxin type A/electromotive drug administration (BoNTA/EMDA) on constipation in these children and compared its efficacy with routine intrasphincteric BoNTA injection.
METHODS
From 2017 to 2019, 60 children aged 5-13 years who fulfilled Rome III criteria for intractable constipation were enrolled and randomly assigned into 2 treatment groups. EMDA group (n = 30) underwent BoNTA/EMDA, whereas the control group (n = 30) received injection of BoNTA into the internal anal sphincter. A complete bowel habit diary (with data on the frequency of defecation per week, stool form, and the number of fecal soiling episodes), a constipation score questionnaire, and a visual pain score were recorded before treatment and at 1 month and 6 months after treatment. In addition, children in both groups were assessed with a constipation-related quality of life questionnaire.
RESULTS
After 1-month follow-up, treatment reduced the number of patients fulfilling the diagnostic criteria in both EMDA (24/30, 80%) and injection (25/30, 83.3%) groups (P < 0.001). The stool form was normalized in 73.3% (22/30) in EMDA group and 80% (24/30) in injection group after treatment. The median of constipation score and pain score decreased significantly in both groups after treatment (P < 0.001 and P < 0.001, respectively).
DISCUSSION
BoNTA/EMDA seems to be as effective as intrasphincteric BoNTA injection for treatment of intractable constipation. In addition, this technique is associated with less comorbidity, is less costly, and can be performed in an office-based setting without general anesthesia.",2020,"After 1-month follow-up, treatment reduced the number of patients fulfilling the diagnostic criteria in both EMDA (24/30, 80%) and injection (25/30, 83.3%) groups (P < 0.001).","['Children With Intractable Constipation', 'From 2017 to 2019, 60 children aged 5-13 years who fulfilled Rome III criteria for intractable constipation']","['EMDA', 'intrarectal botulinum toxin type A/electromotive drug administration (BoNTA/EMDA', 'Intrarectal Electromotive Botulinum Toxin Type A Administration']","['number of fecal soiling episodes), a constipation score questionnaire, and a visual pain score', 'constipation-related quality of life questionnaire', 'median of constipation score and pain score', 'number of patients fulfilling the diagnostic criteria in both EMDA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0221152', 'cui_str': 'Obstipation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0037592', 'cui_str': 'Soil'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",60.0,0.0505487,"After 1-month follow-up, treatment reduced the number of patients fulfilling the diagnostic criteria in both EMDA (24/30, 80%) and injection (25/30, 83.3%) groups (P < 0.001).","[{'ForeName': 'Abdol-Mohammad', 'Initials': 'AM', 'LastName': 'Kajbafzadeh', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Lida', 'Initials': 'L', 'LastName': 'Sharifi-Rad', 'Affiliation': ""Department of Physical Therapy, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Nabavizadeh', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Seyedeh-Sanam', 'Initials': 'SS', 'LastName': 'Ladi-Seyedian', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Alijani', 'Affiliation': ""Pediatric Urology and Regenerative Medicine Research Center, Children's Medical Center, Pediatric Center of Excellence, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Farahmand', 'Affiliation': ""Pediatric Gastroenterology and Hepatology Research Center, Department of Pediatrics, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Motamed', 'Affiliation': ""Pediatric Gastroenterology and Hepatology Research Center, Department of Pediatrics, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Alimadadi', 'Affiliation': ""Pediatric Gastroenterology and Hepatology Research Center, Department of Pediatrics, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Fallahi', 'Affiliation': ""Pediatric Gastroenterology and Hepatology Research Center, Department of Pediatrics, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}, {'ForeName': 'Gholam-Hossein', 'Initials': 'GH', 'LastName': 'Fallahi', 'Affiliation': ""Pediatric Gastroenterology and Hepatology Research Center, Department of Pediatrics, Pediatric Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran (IRI).""}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000940']
2080,33009160,"""Babywearing"" in the NICU: An Intervention for Infants With Neonatal Abstinence Syndrome.","BACKGROUND
The US opioid epidemic has resulted in an increase of infants at risk for developing neonatal abstinence syndrome (NAS). Traditionally, treatment has consisted of pharmacological interventions to reduce symptoms of withdrawal. However, nonpharmacological interventions (eg, skin-to-skin contact, holding) can also be effective in managing the distress associated with NAS.
PURPOSE
The purpose of this study was to examine whether infant carrying or ""babywearing"" (ie, holding an infant on one's body using cloth) can reduce distress associated with NAS among infants and caregivers.
METHODS
Heart rate was measured in infants and adults (parents vs other adults) in a neonatal intensive care unit (NICU) pre- (no touching), mid- (20 minutes into being worn in a carrier), and post-babywearing (5 minutes later).
RESULTS
Using a 3-level hierarchical linear model at 3 time points (pre, mid, and post), we found that babywearing decreased infant and caregiver heart rates. Across a 30-minute period, heart rates of infants worn by parents decreased by 15 beats per minute (bpm) compared with 5.5 bpm for infants worn by an unfamiliar adult, and those of adults decreased by 7 bpm (parents) and nearly 3 bpm (unfamiliar adult).
IMPLICATIONS FOR PRACTICE
Results from this study suggest that babywearing is a noninvasive and accessible intervention that can provide comfort for infants diagnosed with NAS. Babywearing can be inexpensive, support parenting, and be done by nonparent caregivers (eg, nurses, volunteers).
IMPLICATIONS FOR RESEARCH
Close physical contact, by way of babywearing, may improve outcomes in infants with NAS in NICUs and possibly reduce the need for pharmacological treatment.See the video abstract for a digital summary of the study. VIDEO ABSTRACT AVAILABLE AT:.",2020,"Across a 30-minute period, heart rates of infants worn by parents decreased by 15 beats per minute (bpm) compared with 5.5 bpm for infants worn by an unfamiliar adult, and those of adults decreased by 7 bpm (parents) and nearly 3 bpm (unfamiliar adult).
","['infants at risk for developing neonatal abstinence syndrome (NAS', 'infants and adults (parents vs other adults) in a neonatal intensive care unit (NICU) pre- ', 'infants with NAS in NICUs', 'Infants With Neonatal Abstinence Syndrome', 'infants diagnosed with NAS']","['Babywearing"" in the NICU']",['heart rates of infants worn by parents'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.0543725,"Across a 30-minute period, heart rates of infants worn by parents decreased by 15 beats per minute (bpm) compared with 5.5 bpm for infants worn by an unfamiliar adult, and those of adults decreased by 7 bpm (parents) and nearly 3 bpm (unfamiliar adult).
","[{'ForeName': 'Lela Rankin', 'Initials': 'LR', 'LastName': 'Williams', 'Affiliation': 'School of Social Work Tucson, Arizona State University, Tucson (Dr Williams and Ms Gebler-Wolfe); Division of Neonatology, Department of Pediatrics, Banner University Medical Center Tucson, Tucson, Arizona (Ms Grisham and Dr Bader); and Division of Neonatology, Department of Pediatrics, University of Arizona, Tucson (Dr Bader).'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Gebler-Wolfe', 'Affiliation': ''}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Grisham', 'Affiliation': ''}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bader', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000788']
2081,33016896,Improving motion detection via anodal transcranial direct current stimulation.,"BACKGROUND
To study motion perception, a stimulus consisting of a field of small, moving dots is often used. Generally, some of the dots coherently move in the same direction (signal) while the rest move randomly (noise). A percept of global coherent motion (CM) results when many different local motion signals are combined. CM computation is a complex process that requires the integrity of the middle-temporal area (MT/V5) and there is evidence that increasing the number of dots presented in the stimulus makes such computation more efficient.
OBJECTIVE
In this study, we explored whether anodal direct current stimulation (tDCS) over MT/V5 would increase individual performance in a CM task at a low signal-to-noise ratio (SNR, i.e. low percentage of coherent dots) and with a target consisting of a large number of moving dots (high dot numerosity, e.g. >250 dots) with respect to low dot numerosity (<60 dots), indicating that tDCS favour the integration of local motion signal into a single global percept (global motion).
METHOD
Participants were asked to perform a CM detection task (two-interval forced-choice, 2IFC) while they received anodal, cathodal, or sham stimulation on three different days.
RESULTS
Our findings showed no effect of cathodal tDCS with respect to the sham condition. Instead, anodal tDCS improves performance, but mostly when dot numerosity is high (>400 dots) to promote efficient global motion processing.
CONCLUSIONS
The present study suggests that tDCS may be used under appropriate stimulus conditions (low SNR and high dot numerosity) to boost the global motion processing efficiency, and may be useful to empower clinical protocols to treat visual deficits.",2020,Our findings showed no effect of cathodal tDCS with respect to the sham condition.,"['Participants were asked to perform a CM detection task (two-interval forced-choice, 2IFC) while they received']","['anodal direct current stimulation (tDCS) over MT/V5', 'anodal tDCS', 'tDCS', 'anodal, cathodal, or sham stimulation']",[],"[{'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],,0.0409238,Our findings showed no effect of cathodal tDCS with respect to the sham condition.,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Battaglini', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Mena', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Casco', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201050']
2082,33010985,Prostate-specific Antigen Progression in Enzalutamide-treated Men with Nonmetastatic Castration-resistant Prostate Cancer: Any Rise in Prostate-specific Antigen May Require Closer Monitoring.,"BACKGROUND
There is no universally accepted definition for prostate-specific antigen (PSA) progression. However, changes in PSA in patients with castration-resistant prostate cancer (CRPC) are used to inform treatment decisions.
OBJECTIVE
To determine whether the Prostate Cancer Working Group 2 (PCWG2) definition of PSA progression is adequate to predict radiographic or clinical progression in enzalutamide-treated men with nonmetastatic CRPC (nmCRPC).
DESIGN, SETTING, AND PARTICIPANTS
A post hoc, retrospective analysis of men with nmCRPC from PROSPER (NCT02003924) was performed.
INTERVENTION
Continued androgen deprivation therapy; patients randomized 2:1 to enzalutamide 160 mg/d or placebo.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Metastasis-free survival (MFS) in men with and without PSA progression, defined by PCWG2, and PSA at the time of radiographic progression were assessed.
RESULTS AND LIMITATIONS
As of June 28, 2017, in enzalutamide-treated patients, the risk of metastasis or death was increased significantly in those with PSA progression versus those without (hazard ratio [HR] 3.99; 95% confidence interval [CI], 2.95-5.41; p < 0.0001). Median MFS was not reached (NR; 95% CI, NR-NR) in patients without PSA progression and was 22.6 mo (95% CI, 21.9-29.0) in those with PSA progression. In placebo-treated patients, PSA progression was not significantly associated with MFS (HR 1.72; 95% CI, 0.86-3.45; p = 0.1). Median MFS was NR (95% CI, 25.6-NR) in patients without PSA progression and 18.3 mo (95% CI, 14.9-19.4) in those with PSA progression. The median PSA increase from nadir at the time of radiographic progression was 1.4 ng/mL in enzalutamide-treated men and 25.6 ng/mL for the placebo arm.
CONCLUSIONS
In men with nmCRPC and rapidly rising PSA, radiographic progression often occurred without PCWG2-defined PSA progression, suggesting that any increase in PSA may warrant closer monitoring. While PCWG2-defined PSA progression was associated with radiographic progression in enzalutamide-treated men, our findings argue for prospective re-evaluation of this threshold.
PATIENT SUMMARY
In this report, we looked at changes in prostate-specific antigen (PSA) in enzalutamide-treated men with nonmetastatic castration-resistant prostate cancer who no longer respond to testosterone-lowering treatment. We found that even very small changes in PSA while on treatment could be an early indication of disease progression and should trigger closer monitoring.",2020,"Median MFS was not reached (NR; 95% CI, NR-NR) in patients without PSA progression and was 22.6 mo (95% CI, 21.9-29.0) in those with PSA progression.","['men with nmCRPC from PROSPER (NCT02003924) was performed', 'Enzalutamide-treated Men with Nonmetastatic Castration-resistant Prostate Cancer', 'enzalutamide-treated men with nonmetastatic CRPC (nmCRPC', 'patients with castration-resistant prostate cancer (CRPC', 'treated men with nonmetastatic castration-resistant prostate cancer who no longer respond to testosterone-lowering treatment']","['enzalutamide 160\u2009mg/d or placebo', 'enzalutamide', 'placebo']","['prostate-specific antigen (PSA', 'PCWG2, and PSA at the time of radiographic progression', 'risk of metastasis or death', 'PSA progression', 'Metastasis-free survival (MFS', 'Median MFS', 'median PSA increase from nadir at the time of radiographic progression', 'radiographic progression']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.203154,"Median MFS was not reached (NR; 95% CI, NR-NR) in patients without PSA progression and was 22.6 mo (95% CI, 21.9-29.0) in those with PSA progression.","[{'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'University of Montreal Hospital Center (CHUM), Montreal, QC, Canada. Electronic address: fred.saad@umontreal.ca.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Efstathiou', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'University of Paris Saclay, Villejuif, France.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Modelska', 'Affiliation': 'Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Pfizer Inc., La Jolla, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sugg', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, IL, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Noerby', 'Affiliation': 'Sygehus, Lillebælt, Vejle, Denmark.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL, USA.'}]",European urology,['10.1016/j.eururo.2020.08.025']
2083,32979978,"Gabapentin for chronic pelvic pain in women (GaPP2): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND
Chronic pelvic pain affects 2-24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology.
METHODS
We performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762.
FINDINGS
Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13-16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was -1·4 (SD 2·3) in the gabapentin group and -1·2 (SD 2·1) in the placebo group (adjusted mean difference -0·20 [97·5% CI -0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was -1·1 (SD 2·0) in the gabapentin group and -0·9 (SD 1·8) in the placebo group (adjusted mean difference -0·18 [97·5% CI -0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group.
INTERPRETATION
This study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology.
FUNDING
National Institute for Health Research.",2020,The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5,"['women with chronic pelvic pain', '39 UK hospital centres', 'Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration', 'women with chronic pelvic pain and no obvious pelvic pathology', 'Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously', 'chronic pelvic pain in women (GaPP2', 'Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to']","['Gabapentin', 'gabapentin', 'placebo', 'gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo', 'gabapentin and 153 to placebo']","['mean worst NRS pain score', 'mean average NRS pain score', 'efficacy and safety', 'average numerical rating scale (NRS) pain scores', 'serious adverse event', 'average pain scores assessed separately on a numerical rating scale', 'Self-reported adverse events', 'Dizziness, drowsiness, and visual disturbances', 'pain scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4546343', 'cui_str': 'Uses contraception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4517675', 'cui_str': '2700'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0547030', 'cui_str': 'Visual disturbance'}]",39.0,0.778431,The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5,"[{'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK. Electronic address: andrew.horne@ed.ac.uk.""}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Vincent', 'Affiliation': ""Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK.""}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Hewitt', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': 'Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Magda', 'Initials': 'M', 'LastName': 'Koscielniak', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szubert', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Doust', 'Affiliation': ""MRC Centre for Reproductive Health, Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': 'Nottingham Clinical Trials Unit, University of Nottingham, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31693-7']
2084,32980788,Acceptability of real-time video counselling compared to other behavioural interventions for smoking cessation in rural and remote areas.,"BACKGROUND
This study evaluated the acceptability of real-time video counselling compared to a) telephone counselling and b) written materials in assisting rural and remote residents to quit smoking.
METHODS
Participants were recruited into a three-arm, parallel group randomised trial and randomly allocated to either: a) real-time video counselling; b) telephone counselling; or c) written materials. At 4-months post-baseline participants completed an online survey that examined self-reported acceptability and helpfulness of the support.
RESULTS
Overall, 93.5 % of video counselling participants and 96.2 % of telephone counselling participants who received support thought it was acceptable for a smoking cessation advisor to contact them via video software or telephone respectively. There were significant differences between video counselling and telephone counselling groups on three of 10 acceptability or helpfulness measures. Video counselling participants had significantly lower odds of reporting the number of calls were about right (OR 0.50, 95 % CI 0.27-0.93), recommending the support to family and friends (OR 0.18, 95 % CI 0.04-0.85) and reporting the support helped with motivation to try quitting (OR 0.24, 95 % CI 0.07-0.76) compared to telephone counselling participants. Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
CONCLUSIONS
Real-time video counselling for smoking cessation is acceptable and well-received by those living in rural and remote locations. Further research is required to enhance the three attributes that were less acceptable for video counselling than telephone counselling.",2020,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","['Participants', 'smoking cessation in rural and remote areas', 'assisting rural and remote residents to quit smoking']","['behavioural interventions', 'real-time video counselling compared to a) telephone counselling and b) written materials', 'real-time video counselling; b) telephone counselling; or c) written materials', 'Video counselling', 'real-time video counselling', 'video counselling']",['number of calls'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",,0.115344,"Video counselling participants had significantly greater odds than written materials participants of rating the support favourably on all seven acceptability and helpfulness items compared.
","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia. Electronic address: Judith.byaruhanga@uon.edu.au.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308 Australia; Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287 Australia; Hunter Medical Research Institute, Locked bag 1000, New Lambton, New South Wales 2305 Australia.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108296']
2085,32981799,Effect of one-anastomosis gastric bypass on cardiovascular risk factors in patients with vitamin D deficiency and morbid obesity: A secondary analysis.,"BACKGROUND AND AIMS
Bariatric patients often suffer from vitamin D (VD) deficiency, and both, morbid obesity and VD deficiency, are related to an adverse effect on cardiovascular disease (CVD) risk. Therefore, we assessed the change of known CVD risk factors and its associations during the first 12 months following one-anastomosis gastric bypass (OAGB).
METHODS AND RESULTS
In this secondary analysis, CVD risk factors, medical history and anthropometric data were assessed in fifty VD deficient (25-hydroxy-vitamin D (25(OH)D) <75 nmol/l) patients, recruited for a randomized controlled trial of VD supplementation. Based on previous results regarding bone-mass loss and the association between VD and CVD risk, the study population was divided into patients with 25(OH)D ≥50 nmol/l (adequate VD group; AVD) and into those <50 nmol/l (inadequate VD group; IVD) at 6 and 12 months (T6/12) postoperatively. In the whole cohort, substantial remission rates for hypertension (38%), diabetes (30%), and dyslipidaemia (41%) and a significant reduction in CVD risk factors were observed at T12. Changes of insulin resistance markers were associated with changes of total body fat mass (TBF%), 25(OH)D, and ferritin. Moreover, significant differences in insulin resistance markers between AVD and IVD became evident at T12.
CONCLUSION
These findings show that OAGB leads to a significant reduction in CVD risk factors and amelioration of insulin resistance markers, which might be connected to reduced TBF%, change in 25(OH)D and ferritin levels, as an indicator for subclinical inflammation, and an adequate VD status. REGISTERED AT CLINICALTRIALS.GOV: (Identifier: NCT02092376) and EudraCT (Identifier: 2013-003546-16).",2020,"Changes of insulin resistance markers were associated with changes of total body fat mass (TBF%), 25(OH)D, and ferritin.","['Bariatric patients often suffer from vitamin D (VD) deficiency, and both, morbid obesity and VD deficiency', 'patients with vitamin D deficiency and morbid obesity']","['EudraCT ', 'anastomosis gastric bypass']","['cardiovascular risk factors', 'dyslipidaemia', 'substantial remission rates for hypertension', 'CVD risk factors and amelioration of insulin resistance markers', 'CVD risk factors', 'insulin resistance markers', 'total body fat mass (TBF%), 25(OH)D, and ferritin', 'CVD risk factors, medical history and anthropometric data']","[{'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0262926', 'cui_str': 'History of'}]",,0.0332122,"Changes of insulin resistance markers were associated with changes of total body fat mass (TBF%), 25(OH)D, and ferritin.","[{'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Kruschitz', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Austria; Division of Internal Medicine, General Public Hospital of the Order of Saint Elisabeth, Klagenfurt, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Wakolbinger', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Austria; Department of Social and Preventive Medicine, Centre for Public Health, Medical University of Vienna, Austria. Electronic address: maria.wakolbinger@meduniwien.ac.at.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schindler', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Prager', 'Affiliation': 'Division of General Surgery, Department of Surgery, Medical University of Vienna, Austria.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Hoppichler', 'Affiliation': 'Special Institute for Preventive Cardiology and Nutrition - SIPCAN, Salzburg, Austria; Division of Internal Medicine, General Public Hospital of the Brothers of Saint John of God Salzburg, Austria.'}, {'ForeName': 'Rodrig', 'Initials': 'R', 'LastName': 'Marculescu', 'Affiliation': 'Clinical Institute for Medical and Chemical Laboratory Diagnostics, Department of Laboratory Medicine, Medical University of Vienna, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ludvik', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Austria; Department of Medicine 1, Karl Landsteiner Institute for Obesity and Metabolic Disorders, Rudolfstiftung Hospital, Vienna, Austria.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.08.011']
2086,32987346,The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome.,"BACKGROUND
Taping is frequently used as part of the multi-modal management for patellofemoral pain syndrome (PFPS). McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT) are proposed to be useful adjuncts to the management of PFPS. However, it is unclear if TIRLT offers similar benefits to PFJT, and its effect on pain and lower limb kinematics have not been investigated previously.
RESEARCH QUESTION
What are the effects of TIRLT, PFJT and no taping on perceived pain and lower limb kinematics during a lunge and single leg squat (SLS) in people with PFPS?
METHODS
This cross-sectional study compared the effects of TIRLT, PFJT and no taping, on knee pain and lower limb kinematics during two pain-provoking movements in people with PFPS. Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions: TIRLT, PFJT and no taping. The Codamotion system captured and analysed lower limb kinematic data in the sagittal, transverse and coronal planes. Peak knee pain intensity during the movement was assessed using the Numerical Rating Scale (NRS).
RESULTS
Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively). There was no evidence of altered lower limb kinematics accompanying pain reductions with either taping technique.
SIGNIFICANCE
Both forms of taping may be useful adjuncts as the short-term benefit of pain relief may enable participation in more active forms of rehabilitation.",2020,"RESULTS
Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","['people with PFPS', 'Participants with PFPS (n = 23) performed a lunge and SLS under three randomised conditions', 'people with Patellofemoral pain syndrome', 'patellofemoral pain syndrome (PFPS']","['McConnell Patellofemoral Joint Taping (PFJT) and Tibial Internal Rotation Limitation Taping (TIRLT', 'TIRLT, PFJT and no taping', 'McConnell patellofemoral joint and tibial internal rotation limitation taping techniques']","['Numerical Rating Scale (NRS', 'pain', 'Peak knee pain intensity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0447801', 'cui_str': 'Structure of patellofemoral joint'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",23.0,0.053827,"RESULTS
Participants reported significantly less pain with the TIRLT and PFJT techniques compared with no tape during the lunge (p = 0.005 and p = 0.011, respectively) and SLS (p= 0.002 and p = 0.001, respectively).","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Clifford', 'Affiliation': 'School of Allied Health and Health Research Institute, University of Limerick, Limerick, Ireland. Electronic address: Amanda.clifford@ul.ie.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dillon', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin 9, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hartigan', 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': ""O'Leary"", 'Affiliation': 'Physiotherapy Department, University Hospital Kerry, Kerry, Ireland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Constantinou', 'Affiliation': 'School of Allied Health, Faculty of Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.09.010']
2087,32987359,Cognitive impairment in Parkinson's disease: Associations between subjective and objective cognitive decline in a large longitudinal study.,"BACKGROUND
Cognitive decline creates substantial morbidity and cost in Parkinson's disease (PD) and clinicians have limited tools for counseling patients on prognosis. We aimed to use data from a randomized, controlled trial of isradipine in Parkinson's disease (STEADY-PD III) to determine which objective cognitive domain deficits drive patient complaints of cognitive symptoms.
METHODS
Neuro-Quality of Life (Neuro-QoL) Cognition: General Concerns (GC), and Cognition: Executive Function (EF) (subjective measures), were administered at baseline, 1, 2, and 3 years in 324 people with PD. Baseline Montreal Cognitive Assessment (MoCA) was divided into 4 domains: visuospatial/executive, memory, attention, and language (objective measures). Spearman rank correlations and multiple regression models adjusted for other clinical variables evaluated associations between baseline Neuro-QoL domains and individual MoCA domains. Multiple regression models evaluated the association between baseline MoCA domain performance and Neuro-QoL change over three years. Cox proportional hazards predicted development of PD-MCI based on baseline and time-varying Neuro-QoL reporting.
RESULTS
Higher MoCA memory performance was associated with better Neuro-QoL-GC (β = 0.75, SE = 0.391, p = 0.05) and Neuro-QoL-EF (β = 0.81, SE = 0.36, p = 0.02) at baseline. There was a trend for baseline MoCA memory to predict the degree of subjective cognitive decline on the Neuro-QoL-EF (β = 0.70, SE = 0.42, p = 0.09). Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC. Increasing subjective cognitive complaints in Neuro-QoL-EF were associated with development of PD-MCI over 3 years of follow-up (HR = 0.95, CI = 0.90-1.0, p = 0.039).
CONCLUSIONS
Objective memory impairment may be a stronger predictor than executive or visuospatial dysfunction for the presence of subjective cognitive complaints in early PD.",2020,Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC.,"['324 people with PD', ""Parkinson's disease""]",['isradipine'],"['General Concerns (GC), and Cognition: Executive Function (EF) (subjective measures', 'visuospatial/executive, memory, attention, and language (objective measures', 'Neuro-Quality of Life (Neuro-QoL) Cognition', 'subjective cognitive complaints', 'Cognitive impairment', 'Baseline Montreal Cognitive Assessment (MoCA', 'baseline MoCA domain performance and Neuro-QoL change']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",324.0,0.0435964,Baseline depression and anticholinergic use were associated with worsened Neuro-QoL-EF and Neuro-QoL-GC.,"[{'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mills', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kmills16@jhmi.edu.'}, {'ForeName': 'Ruth B', 'Initials': 'RB', 'LastName': 'Schneider', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Saint-Hilaire', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'G Webster', 'Initials': 'GW', 'LastName': 'Ross', 'Affiliation': 'VA Pacific Islands Health Care System, Honolulu, HI, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'University of South Florida Morsani College of Medicine, Tampa, FL, USA.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Lang', 'Affiliation': ""Edmond J Safra Program in Parkinson's Disease, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Halverson', 'Affiliation': 'The University of Utah School of Medicine, East Salt Lake City, UT, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Oakes', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Eberly', 'Affiliation': 'University of Rochester School of Medicine and Density, Rochester, NY, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Litvan', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Blindauer', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Aquino', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Simuni', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Marras', 'Affiliation': ""Edmond J Safra Program in Parkinson's Disease, Toronto Western Hospital, UHN, Division of Neurology, University of Toronto, Toronto, ON, Canada.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.028']
2088,32987360,Action observation improves sit-to-walk in patients with Parkinson's disease and freezing of gait. Biomechanical analysis of performance.,"INTRODUCTION
Freezing of gait (FoG) is one of the most disabling gait disorders in Parkinson's disease (PD), reflecting motor and cognitive impairments, mainly related to dopamine deficiency. Recent studies investigating kinematic and kinetic factors affecting gait in these patients showed a postural instability characterized by disturbed weight-shifting, inappropriate anticipatory postural adjustment, worse reactive postural control, and a difficulty executing complex motor tasks (i.e. sit-to-walk). These symptoms are difficult to alleviate and not very responsive to Levodopa. For this reason, additional therapeutic actions based on specific therapeutic protocols may help patients with their daily lives. We conducted a randomized control trial aimed to test if two clinical protocols for PD patients with FoG were effective to improve postural control.
METHODS
Rehabilitation protocols, conceived to improve gait, were based on learning motor exercises with the Action Observation plus Sonification (AOS) technique, or by the use of external sensory cues. We collected biomechanical data (Center of Mass COM, Center of Pressure COP, and moving timings), using the sit-to-walk task as a measure of motor and gait performance.
RESULTS
Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
CONCLUSION
We demonstrated for the first time that PD patients with FoG treated with an AOS protocol aimed at relearning appropriate gait patterns increased balance control and re-acquired more efficient postural control.",2020,"RESULTS
Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
","[""patients with Parkinson's disease and freezing of gait"", 'PD patients with FoG']","['learning motor exercises with the Action Observation plus Sonification (AOS) technique, or by the use of external sensory cues', 'Freezing of gait (FoG']","['total moving time and the area of the COP positions', 'balance control and re-acquired more efficient postural control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}]",,0.0179806,"RESULTS
Kinetic and kinematic data showed that when treatment effects consolidate, patients treated with AOS protocol are more efficient in merging subsequent motor tasks (sit-to-stand and gait initiation), and diminished the total moving time and the area of the COP positions.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Mezzarobba', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy; Azienda Sanitaria Universitaria Giuliano Isontina, Italy; Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Grassi', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Pellegrini', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Catalan', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Krüger', 'Affiliation': 'Gokhale Method Institute, CA, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Stragapede', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manganotti', 'Affiliation': 'Azienda Sanitaria Universitaria Giuliano Isontina, Italy; Department of Medical, Surgical and Health Sciences, University of Trieste, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bernardis', 'Affiliation': 'Department of Life Sciences, University of Trieste, Italy. Electronic address: pbernardis@units.it.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.09.029']
2089,33237229,Effect of Endodontic Sealer in Young Molars Treated by Undergraduate Students - A Randomized Clinical Trial.,"The progression of caries in permanent molar teeth of young patients, frequently result in endodontic treatment. This randomized blinded clinical trial assessed the effect of two endodontic sealers (Sealer 26 and AH Plus) on the incidence of pain and apical repair after endodontic treatment of young molar teeth, and secondly identify factors associated with the outcomes. Endodontic treatment was performed by undergraduate students in molar teeth (n=69) of young patients (n=54) at the Endodontic and Restorative Public Extension Clinic Service. Protaper Next was used and the endodontic sealers were allocated which were restored with direct composite resin. Two primary clinical outcomes - apical repair and postoperative pain, were assessed after 12 and 24 months for blinded operators. Description of incidence rates and mixed-model regression using Generalized Estimation Equations (GEE). After 2 years 69 molar teeth of 54 patients were evaluated. No effect of the endodontic sealer was observed irrespective of period of evaluation. Apical repair incidences and asymptomatic teeth were, respectively, 90.5 and 89.3, 96.8 and 90.0% during 1 and 2 years of follow-up. Failed apical repair was associated with unsatisfactory pulpectomy (p=0.003) and periapical conditions (p=0.007) as well as their interaction (p=0.016). None of these independent variables was able to predict the occurrence of pain in both periods. Prognosis of apical repair is dependent on the initial conditions. Endodontic treatment of young molars associated with composite resin restorations performed by undergraduate students have satisfactory results after 2 years and was effective to prevent the risk of permanent teeth loss.",2020,Failed apical repair was associated with unsatisfactory pulpectomy (p=0.003) and periapical conditions (p=0.007) as well as their interaction (p=0.016).,"['Young Molars Treated by Undergraduate Students', 'undergraduate students in molar teeth (n=69) of young patients (n=54) at the Endodontic and Restorative Public Extension Clinic Service', 'young molars associated with composite resin restorations performed by undergraduate students', 'After 2 years 69 molar teeth of 54 patients']","['endodontic sealers (Sealer 26 and AH Plus', 'Endodontic Sealer', 'endodontic sealer']","['periapical conditions', 'occurrence of pain', 'Failed apical repair', 'apical repair and postoperative pain', 'risk of permanent teeth loss', 'progression of caries', 'incidence of pain and apical repair', 'Apical repair incidences and asymptomatic teeth']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0215126', 'cui_str': 'Sealer 26'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}]","[{'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0348070', 'cui_str': 'Structure of permanent tooth'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]",54.0,0.0936708,Failed apical repair was associated with unsatisfactory pulpectomy (p=0.003) and periapical conditions (p=0.007) as well as their interaction (p=0.016).,"[{'ForeName': 'Suely Aparecida', 'Initials': 'SA', 'LastName': 'Cunha', 'Affiliation': 'Biomechanics Research Group, Department of Operative Dentistryand Dental Materials, School of Dentistry, UFU - Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Carlos José', 'Initials': 'CJ', 'LastName': 'Soares', 'Affiliation': 'Biomechanics Research Group, Department of Operative Dentistryand Dental Materials, School of Dentistry, UFU - Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Camila Maria Peres', 'Initials': 'CMP', 'LastName': 'Rosatto', 'Affiliation': 'Department of Endodontics, School of Dentistry, UFU - Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'João Victor Soares Mendonça', 'Initials': 'JVSM', 'LastName': 'Vieira', 'Affiliation': 'Department of Endodontics, School of Dentistry, UFU - Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Renata Afonso da Silva', 'Initials': 'RADS', 'LastName': 'Pereira', 'Affiliation': 'Biomechanics Research Group, Department of Operative Dentistryand Dental Materials, School of Dentistry, UFU - Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Priscilla Barbosa Ferreira', 'Initials': 'PBF', 'LastName': 'Soares', 'Affiliation': 'Department of Periodontology and Implantology, School of Dentistry, UFU - Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'Department of Prevention and Oral Rehabilitation, School of Dentistry, UFG - Universidade Federal de Goiás, Goiânia, GO, Brazil.'}, {'ForeName': 'Camilla Christian Gomes', 'Initials': 'CCG', 'LastName': 'Moura', 'Affiliation': 'Department of Endodontics, School of Dentistry, UFU - Universidade Federal de Uberlândia, Uberlândia, MG, Brazil.'}]",Brazilian dental journal,['10.1590/0103-6440202003258']
2090,32996096,"Repository Corticotropin Injection for Persistently Active Systemic Lupus Erythematosus: Results from a Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION
We assessed the efficacy and safety of repository corticotropin injection (RCI; Acthar ® Gel) for persistently active systemic lupus erythematosus (SLE) despite use of moderate-dose glucocorticoids.
METHODS
This multicenter, double-blind, randomized, placebo-controlled study enrolled patients ≥ 18 years with active SLE and moderate to severe rash and/or arthritis despite stable glucocorticoid doses (7.5-30 mg/day prednisone equivalent) and antimalarials for ≥ 4 weeks and/or immunosuppressants for ≥ 8 weeks before screening. Stable glucocorticoid doses were required through week 16 with optional taper from weeks 16 to 24. Patients were randomized (1:1) to 80 U RCI subcutaneously or placebo every other day to week 4, then twice weekly to week 24. Endpoints included the proportion of SLE Responder Index (SRI)-4 responders at week 16; changes from baseline to week 16 in 28 Swollen Joint Count/Tender Joint Count (28 SJC/TJC) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-Activity score; and changes from baseline to week 24 in inflammatory cytokines. Safety was assessed by adverse events.
RESULTS
In the modified intention-to-treat population (RCI, n = 84; placebo, n = 85), the proportion of SRI-4 responders at week 16 was not significantly different between groups (RCI, 47.6%; placebo, 43.5%; OR [95% CI] 1.2 [0.6 to 2.2]; p = 0.5762). RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine. Post hoc analyses demonstrated a greater proportion of BILAG-based Combined Lupus Assessment responders for RCI than placebo at weeks 4, 12, and 20 and greater SRI-4 response in RCI-treated patients with baseline SLE Disease Activity Index-2000 ≥ 10 and CLASI-Activity ≥ 11. No new safety signals were identified.
CONCLUSIONS
Despite failure to achieve the primary endpoint, these results support the utility of RCI for treating persistently active SLE.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT02953821.",2020,RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine.,"['Active Systemic Lupus Erythematosus', 'persistently active systemic lupus erythematosus (SLE', 'enrolled patients\u2009≥', '18\xa0years with active SLE and moderate\xa0to\xa0severe rash and/or arthritis despite stable']","['RCI subcutaneously or placebo', 'Repository Corticotropin Injection', 'repository corticotropin injection (RCI; Acthar ® Gel', 'placebo', 'glucocorticoid', 'Placebo']","['Safety', 'proportion of SLE Responder Index (SRI)-4 responders', 'Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)-Activity score', 'TJC and CLASI-Activity score', 'efficacy and safety', 'proportion of SRI-4 responders', 'SRI-4 response']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0718234', 'cui_str': 'Acthar'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0024137', 'cui_str': 'Cutaneous lupus erythematosus'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.499077,RCI treatment resulted in a reduction from baseline to week 16 in 28 SJC/TJC and CLASI-Activity score and from baseline to week 8 in a proliferation-inducing ligand cytokine.,"[{'ForeName': 'Anca D', 'Initials': 'AD', 'LastName': 'Askanase', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA. ada20@cumc.columbia.edu.'}, {'ForeName': 'Enxu', 'Initials': 'E', 'LastName': 'Zhao', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Bilyk', 'Affiliation': 'Mallinckrodt Pharmaceuticals, Bedminster, NJ, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Furie', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00236-1']
2091,33232804,"Colchicine is not effective for reducing osteoarthritic hand pain compared to placebo: a randomised, placebo-controlled trial (COLAH).","BACKGROUND
Colchicine may offer relief in osteoarthritis. This has never been investigated for hand osteoarthritis.
OBJECTIVES
To investigate the effect of 1 mg daily colchicine vs placebo on hand pain and function over 12 weeks in older adults with hand osteoarthritis.
METHODS
Community-dwelling adults with diagnosed osteoarthritis of the hand aged 40-80 years were randomised to receive colchicine (0.5 mg twice daily) or matching placebo. Primary outcome measure was VAS hand pain score (0-100 mm). Secondary outcome measures included tender and swollen joint count, grip strength, C-reactive protein, and Michigan Hand Questionnaire total, function and pain scores. In an exploratory assessment, we compared synovial grade and power Doppler. All outcome measures were obtained at baseline and week 12. Stata v16 was used to perform constrained longitudinal data analysis models.
RESULTS
64 adults (54 females, 10 males) aged 48-79 years of age were enrolled. 59 participants completed the study (N = 28 colchicine, N = 31 placebo) (withdrawal rate 8%). Adverse reactions to the study medication occurred in nine patients. VAS score was not significantly different at baseline (61 ± 17 mm in the colchicine, 64 ± 17 mm in the placebo group). Between-group difference for VAS score at week 12 was 7.6 mm (95% CI -3.5-18.7, p-value 0.18). There were no significant differences between groups for any secondary outcomes at baseline or week 12.
CONCLUSIONS
1 mg colchicine daily for 12 weeks was not effective for reducing pain, tender and swollen joint count or increasing grip strength in symptomatic hand osteoarthritis. Our results do not support the use of colchicine in hand osteoarthritis.",2020,"CONCLUSIONS
1 mg colchicine daily for 12 weeks was not effective for reducing pain, tender and swollen joint count or increasing grip strength in symptomatic hand osteoarthritis.","['64 adults (54 females, 10 males) aged 48-79 years of age were enrolled', 'older adults with hand osteoarthritis', '59 participants completed the study (N=28', 'osteoarthritis', 'Community-dwelling adults with diagnosed osteoarthritis of the hand aged 40-80 years']","['colchicine (0.5mg twice daily) or matching placebo', 'placebo', 'Colchicine', 'colchicine vs placebo', 'colchicine, N=31 placebo', 'colchicine']","['osteoarthritic hand pain', 'tender and swollen joint count, grip strength, C-reactive protein, and Michigan Hand Questionnaire total, function and pain scores', 'hand pain and function', 'pain, tender and swollen joint count or increasing grip strength', 'Adverse reactions', 'VAS hand pain score', 'VAS score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0239833', 'cui_str': 'Hand pain'}, {'cui': 'C0234234', 'cui_str': 'Tender'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",64.0,0.7197,"CONCLUSIONS
1 mg colchicine daily for 12 weeks was not effective for reducing pain, tender and swollen joint count or increasing grip strength in symptomatic hand osteoarthritis.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Davis', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, South Australia 5000, Australia; Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia. Electronic address: courtney.davis@sa.gov.au.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Ruediger', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, South Australia 5000, Australia; Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Dyer', 'Affiliation': 'Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lester', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, South Australia 5000, Australia; Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Graf', 'Affiliation': 'Wakefield Rheumatology, Adelaide, South Australia 5000, Australia.'}, {'ForeName': 'F P B', 'Initials': 'FPB', 'LastName': 'Kroon', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center (LUMC), Leiden, the Netherlands.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Whittle', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, South Australia 5000, Australia; Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Hill', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, South Australia 5000, Australia; Rheumatology Department, Queen Elizabeth Hospital, Woodville South, South Australia 5000, Australia.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.11.002']
2092,33232855,Restricting ankle dorsiflexion does not mitigate the benefits of external focus of attention on landing biomechanics in healthy females.,"PURPOSE
Restricted ankle dorsiflexion can promote aberrant biomechanics associated with risk for knee injury during dynamic activities. Attentionally focused instructions have been used to improve high-risk knee biomechanics during landing tasks. Yet, it is unknown whether attentionally focused instruction can effectively improve landing patterns in the presence of a mechanical restriction on the ankle. Therefore, our purpose was to determine whether restricting ankle dorsiflexion by use of bracing mitigated the effects of attentional foci on landing biomechanics in healthy females.
METHODS
We used a crossover design to investigate lower extremity biomechanics in 19 healthy females between the ages of 18-35 during a series of jump-landing tasks. Participants completed 6 blocks of 3 jump-landings on separate force platforms in a randomized order based on brace condition (brace, no brace) and mode of attentional foci (neutral, internal focus [IF], external focus [EF]). Attentionally focused instructions were provided immediately prior to 3 practice jump-landings, followed by 5 test jump-landings with self-controlled feedback only.
RESULTS
Ankle bracing decreased peak dorsiflexion and sagittal range of motion (ROM) (mean difference: 5.7-5.8°), and peak inversion and frontal ROM (mean difference: 2.4-3.0°). However, hip flexion ROM (mean difference: 1.8°) increased compared to the no brace condition. Regardless of ankle bracing, EF instruction increased peak hip flexion (mean difference: 4.9°) and hip flexion range of motion (mean difference: 3.8-4.6°), while decreasing peak knee valgus (mean difference: 0.8-1.0°) and knee valgus moment (mean difference: 0.04 Nm/kg). Additionally, EF instruction increased peak hip abduction to a similar degree when braced (mean difference: 3.6-4.0°) and not braced (mean difference: 2.1-2.5°). Lastly, EF instruction increased hip abduction ROM only when braced (mean difference: 2.3-2.4°), but decreased peak knee valgus power only when not braced (mean difference: 0.18 W/kg).
CONCLUSIONS
Our findings indicate that mechanically restricting ankle dorsiflexion does not mitigate the ability of EF instruction to enhance jump-landing performance by means of improving hip and knee biomechanics in healthy females. However, our findings suggest an improved ability to control the rate of knee valgus loading when not braced. Therefore, we conclude that EF instruction remains a viable clinical strategy to improve landing patterns in the presence of restricted ankle dorsiflexion, yet this approach may be ineffective to reduce the rate of knee joint loading.",2020,"Lastly, EF instruction increased hip abduction ROM only when braced (mean difference: 2.3-2.4°), but decreased peak knee valgus power only when not braced (mean difference: 0.18 W/kg).
","['healthy females', '19 healthy females between the ages of 18-35 during a series of jump-landing tasks']","['brace condition (brace, no brace) and mode of attentional foci (neutral, internal focus [IF], external focus [EF', 'EF instruction']","['peak inversion and frontal ROM', 'peak knee valgus', 'knee valgus moment', 'hip flexion range of motion', 'hip abduction ROM', 'peak dorsiflexion and sagittal range of motion (ROM', 'peak knee valgus power', 'hip flexion ROM', 'peak hip abduction', 'peak hip flexion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0557668', 'cui_str': 'Landing'}]","[{'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0042282', 'cui_str': 'Valgus deformity'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}]",19.0,0.0752875,"Lastly, EF instruction increased hip abduction ROM only when braced (mean difference: 2.3-2.4°), but decreased peak knee valgus power only when not braced (mean difference: 0.18 W/kg).
","[{'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Haines', 'Affiliation': 'Athletic Training Program, School of Exercise and Rehabilitation Sciences, University of Toledo, Toledo, OH, USA. Electronic address: Mackenzie.Haines@utoledo.edu.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Physical Therapy Program, School of Exercise and Rehabilitation Sciences, University of Toledo, Toledo, OH, USA. Electronic address: Amanda.Murray2@utoledo.edu.'}, {'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Glaviano', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs, CT, USA. Electronic address: Neal.Glaviano@uconn.edu.'}, {'ForeName': 'Alli', 'Initials': 'A', 'LastName': 'Gokeler', 'Affiliation': 'Exercise Science and Neuroscience Unit, Department of Exercise and Health, Paderborn University, Paderborn, Germany; Amsterdam Collaboration on Health and Safety in Sports, Department of Public and Occupational Health, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: alli.gokeler@uni-paderborn.de.'}, {'ForeName': 'Grant E', 'Initials': 'GE', 'LastName': 'Norte', 'Affiliation': 'Athletic Training Program, School of Exercise and Rehabilitation Sciences, University of Toledo, Toledo, OH, USA. Electronic address: grant.norte@utoledo.edu.'}]",Human movement science,['10.1016/j.humov.2020.102719']
2093,33232856,Musical pleasure beneficially alters stride and arm swing amplitude during rhythmically-cued walking in people with Parkinson's disease.,"Entrainment of walking to rhythmic auditory cues (e.g., metronome and/or music) improves gait in people with Parkinson's disease (PD). Studies on healthy individuals indicate that entrainment to pleasant musical rhythm can be more beneficial for gait facilitation than entrainment to isochronous rhythm, potentially as a function of emotional/motivational responses to music and their associated influence on motor function. Here, we sought to investigate how emotional attributes of music and isochronous cues influence stride and arm swing amplitude in people with PD. A within-subjects experimental trial was completed with persons with PD serving as their own controls. Twenty-three individuals with PD walked to the cue of self-chosen pleasant music cue, pitch-distorted unpleasant music, and an emotionally neutral isochronous drumbeat. All music cues were tempo-matched to individual walking pace at baseline. Greater gait velocity, stride length, arm swing peak velocity and arm swing range of motion (RoM) were found when patients walked to pleasant music cues compared to baseline, walking to unpleasant music, and walking to isochronous cues. Cued walking in general marginally increased variability of stride-to-stride time and length compared with uncued walking. Enhanced stride and arm swing amplitude were most strongly associated with increases in perceived enjoyment and pleasant musical emotions such as power, tenderness, and joyful activation. Musical pleasure contributes to improvement of stride and arm swing amplitude in people with PD, independent of perceived familiarity with music, cognitive demands of music listening, and beat salience. Our findings aid in understanding the role of musical pleasure in invigorating gait in PD, and inform novel approaches for restoring or compensating impaired motor circuits.",2020,"Musical pleasure contributes to improvement of stride and arm swing amplitude in people with PD, independent of perceived familiarity with music, cognitive demands of music listening, and beat salience.","['healthy individuals', 'Twenty-three individuals with PD walked to the cue of self-chosen pleasant music cue, pitch-distorted unpleasant music, and an emotionally neutral isochronous drumbeat', ""people with Parkinson's disease (PD"", 'people with PD', ""people with Parkinson's disease""]","['Musical pleasure beneficially alters stride and arm swing amplitude during rhythmically-cued walking', 'Cued walking', 'Entrainment of walking to rhythmic auditory cues (e.g., metronome and/or music']","['perceived enjoyment and pleasant musical emotions such as power, tenderness, and joyful activation', 'Enhanced stride and arm swing amplitude', 'Greater gait velocity, stride length, arm swing peak velocity and arm swing range of motion (RoM', 'variability of stride-to-stride time and length']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",23.0,0.0565815,"Musical pleasure contributes to improvement of stride and arm swing amplitude in people with PD, independent of perceived familiarity with music, cognitive demands of music listening, and beat salience.","[{'ForeName': 'Kyoung Shin', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Kinesiology, University of North Carolina at Greensboro, United States of America. Electronic address: k_park4@uncg.edu.'}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Hass', 'Affiliation': 'Department of Applied Physiology and Kinesiology, University of Florida, United States of America.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'Fixel Center for Neurological Disease, University of Florida, United States of America.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Janelle', 'Affiliation': 'Department of Applied Physiology and Kinesiology, University of Florida, United States of America.'}]",Human movement science,['10.1016/j.humov.2020.102718']
2094,33233510,Effects of Continuous Intake of Rosemary Extracts on Mental Health in Working Generation Healthy Japanese Men: Post-Hoc Testing of a Randomized Controlled Trial.,"We previously performed a 4 week interventional trial that suggested that continuous intake of rosemary extract improves the mood states, fatigue, and cognitive function of working generation healthy adult Japanese men. However, the severity of depression in participants in our previous study was relatively mild. Therefore, in the present study, a post-hoc analysis of our previous study was conducted, limited to participants whose total mood disturbance (TMD) scores, which indicate greater mood disturbance, were above the median at baseline, to evaluate whether rosemary extract was effective for individuals with poor mental health. Following the intervention, the scores of TMD and ""Confusion-Bewilderment"" were significantly decreased (both p < 0.05), and scores of ""Vigor-Activity"" were significantly increased in the rosemary group ( n = 8) compared with those in the control group ( n = 13; p < 0.01). When comparing the scores from pre- and post-intervention, significant improvements in ""Tension-Anxiety"", ""Vigor-Activity"", ""Fatigue on awakening"", ""Daytime sleepiness"", and ""Psychomotor speed"" were observed in the rosemary group only (all p < 0.05). Based on these results, it was expected that rosemary extracts were effective for improving the mental energy and sleep quality of work-age men with poor mental health.",2020,"Following the intervention, the scores of TMD and ""Confusion-Bewilderment"" were significantly decreased (both p < 0.05), and scores of ""Vigor-Activity"" were significantly increased in the rosemary group ( n = 8) compared with those in the control group ( n = 13; p < 0.01).","['working generation healthy adult Japanese men', 'work-age men with poor mental health', 'Working Generation Healthy Japanese Men', 'individuals with poor mental health']","['Rosemary Extracts', 'rosemary extracts', 'rosemary extract']","['total mood disturbance (TMD) scores', 'mental energy and sleep quality', 'scores of ""Vigor-Activity', 'severity of depression', 'Tension-Anxiety"", ""Vigor-Activity"", ""Fatigue on awakening"", ""Daytime sleepiness"", and ""Psychomotor speed', 'Mental Health', 'scores of TMD and ""Confusion-Bewilderment', 'mood states, fatigue, and cognitive function']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0939869', 'cui_str': 'rosemary extract'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2939186', 'cui_str': 'Disturbance in mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.0274254,"Following the intervention, the scores of TMD and ""Confusion-Bewilderment"" were significantly decreased (both p < 0.05), and scores of ""Vigor-Activity"" were significantly increased in the rosemary group ( n = 8) compared with those in the control group ( n = 13; p < 0.01).","[{'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Araki', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8575, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Open Innovation Laboratory for Food and Medicinal Resource Engineering (Food-Med OIL), AIST-University of Tsukuba, 1-1-1 Higashi, Tsukuba 305-8565, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Onda', 'Affiliation': 'S&B FOODS INC., 38-8 Miyamoto-cho, Itabashi-ku, Tokyo 174-8651, Japan.'}, {'ForeName': 'Syunsuke', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'S&B FOODS INC., 38-8 Miyamoto-cho, Itabashi-ku, Tokyo 174-8651, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kassai', 'Affiliation': 'S&B FOODS INC., 38-8 Miyamoto-cho, Itabashi-ku, Tokyo 174-8651, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Kaneko', 'Affiliation': 'Tokyo Skytree Station Medical Clinic, 3-33-13 Sumida-ku, Tokyo 131-0033, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Isoda', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, 1-2 Kasuga, Tsukuba 305-8550, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Clinical and Translational Research Methodology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba 305-8575, Japan.'}]",Nutrients,['10.3390/nu12113551']
2095,33233658,"A Partly Fermented Infant Formula with Postbiotics Including 3'-GL, Specific Oligosaccharides, 2'-FL, and Milk Fat Supports Adequate Growth, Is Safe and Well-Tolerated in Healthy Term Infants: A Double-Blind, Randomised, Controlled, Multi-Country Trial.","This study investigated growth, safety, and tolerance in healthy infants consuming a partly fermented infant formula (IF) with postbiotics, 2'-linked fucosyllactose (2'-FL), a specific prebiotic mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS), and milk fat. This double-blind, controlled trial randomised 215 fully IF-fed infants ≤ 14 days of age to either: Test Group (IF) containing 26% fermented formula with postbiotics derived from Lactofidus fermentation process (including 3'-Galactosyllactose; 3'-GL), 0.8 g/100 mL scGOS/lcFOS (9:1), 0.1 g/100 mL 2'-FL, and milk fat), or Control group (IF with 0.8 g/100 mL scGOS/lcFOS (9:1)) until 17 weeks of age. Fully breastfed infants were included as a reference. Anthropometric measures, gastrointestinal symptoms, and safety were assessed monthly. Equivalence in weight gain (primary outcome) between the Test and Control groups was confirmed (difference in means -0.08 g/day; 90% CI (-1.47;1.31)) with estimated mean weight gain (SE) of 31.00 (0.59) g/day and 31.08 (0.60) g/day, respectively, (PP population, n = 196). Equivalence in length and head circumference gain between the randomised groups was also confirmed. No statistically significant differences were observed in adverse events or gastrointestinal tolerance between randomised IF groups. A partly fermented IF with postbiotics, specific oligosaccharides, 2'-FL, and milk fat supports adequate infant growth and is safe and well-tolerated in healthy term infants.",2020,No statistically significant differences were observed in adverse events or gastrointestinal tolerance between randomised IF groups.,"['healthy term infants', 'Healthy Term Infants', '215 fully IF-fed infants ≤ 14 days of age to either', ""healthy infants consuming a partly fermented infant formula (IF) with postbiotics, 2'-linked fucosyllactose (2'-FL), a specific prebiotic mixture of short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS), and milk fat""]","[""Test Group (IF) containing 26% fermented formula with postbiotics derived from Lactofidus fermentation process (including 3'-Galactosyllactose; 3'-GL), 0.8 g/100 mL scGOS/lcFOS (9:1), 0.1 g/100 mL 2'-FL, and milk fat), or Control group (IF with 0.8 g/100 mL scGOS/lcFOS""]","['mean weight gain (SE', 'adverse events or gastrointestinal tolerance', 'weight gain', 'Anthropometric measures, gastrointestinal symptoms, and safety', 'Equivalence in length and head circumference gain']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0015852', 'cui_str': 'Fermentation'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0046819', 'cui_str': ""3'-galactosyllactose""}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",215.0,0.420043,No statistically significant differences were observed in adverse events or gastrointestinal tolerance between randomised IF groups.,"[{'ForeName': 'Yvan', 'Initials': 'Y', 'LastName': 'Vandenplas', 'Affiliation': 'KidZ Health Castle, UZ Brussel, Vrije Universiteit Brussel, 1090 Jette, Belgium.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'de Halleux', 'Affiliation': 'Centre Hospitalier Universitaire of Liège (CHU), Centre Hospitalier Régional of Liège (CHR), 4000 Liège, Belgium.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Arciszewska', 'Affiliation': 'Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k., 15-435 Bialystok, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Lach', 'Affiliation': 'Centrum Medyczne Promed, 31-411 Kraków, Poland.'}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Pokhylko', 'Affiliation': 'Ukrainian Medical Stomatological Academy, Poltava Regional Children Clinical Hospital, 36011 Poltava, Ukraine.'}, {'ForeName': 'Viktoriia', 'Initials': 'V', 'LastName': 'Klymenko', 'Affiliation': ""Kharkiv National Medical University, City Children's Clinical Hospital No. 19, 61051 Kharkiv, Ukraine.""}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Schoen', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Abrahamse-Berkeveld', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Mulder', 'Affiliation': 'Danone Nutricia Research, 3584 CT Utrecht, The Netherlands.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Porcel Rubio', 'Affiliation': 'Hospital Quironsalud, 08023 Barcelona, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The Voyage Study Group', 'Affiliation': ''}]",Nutrients,['10.3390/nu12113560']
2096,33233717,A Blended Cognitive-Behavioral Intervention for the Treatment of Postpartum Depression: Study Protocol for a Randomized Controlled Trial.,"Despite the existence of effective treatment for postpartum depression, few women seek professional help, indicating the need for a new and innovative format of treatment that can overcome help-seeking barriers. This article presents the study protocol for a blended cognitive-behavioral intervention for the treatment of postpartum depression, by integrating face-to-face sessions with a web-based program (Be a Mom) into one treatment protocol. This study will be a two-arm, noninferiority randomized controlled trial comparing blended intervention to usual treatment for postpartum depression provided in healthcare centers. Portuguese postpartum adult women diagnosed with postpartum depression (according to the DSM-5 diagnostic criteria for major depressive disorder) will be recruited during routine care appointments in local healthcare centers and will be eligible to participate. Measures will be completed at baseline, postintervention, and at three- and six-month follow-ups. The primary outcome will be depressive symptoms. Secondary outcomes will include anxiety symptoms, fatigue, quality of life, marital satisfaction, maternal self-efficacy, and mother-child bonding. Cost-effectiveness analysis and mediator and moderator analysis will be conducted. This study will provide insight into the efficacy and cost-effectiveness of a blended psychological intervention in the Portuguese context and increase the empirically validated treatment options for postpartum depression.",2020,"Secondary outcomes will include anxiety symptoms, fatigue, quality of life, marital satisfaction, maternal self-efficacy, and mother-child bonding.","['Portuguese postpartum adult women diagnosed with postpartum depression (according to the DSM-5 diagnostic criteria for major depressive disorder', 'Postpartum Depression', 'postpartum depression provided in healthcare centers']","['blended psychological intervention', 'Blended Cognitive-Behavioral Intervention', 'blended cognitive-behavioral intervention', 'blended intervention']","['depressive symptoms', 'efficacy and cost-effectiveness', 'anxiety symptoms, fatigue, quality of life, marital satisfaction, maternal self-efficacy, and mother-child bonding']","[{'cui': 'C0032730', 'cui_str': 'Portuguese'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.110981,"Secondary outcomes will include anxiety symptoms, fatigue, quality of life, marital satisfaction, maternal self-efficacy, and mother-child bonding.","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Branquinho', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3000-115 Coimbra, Portugal.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Canavarro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3000-115 Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Rua do Colégio Novo, 3000-115 Coimbra, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17228631']
2097,33233750,Teacher Training Can Make a Difference: Tools to Overcome the Impact of COVID-19 on Primary Schools. An Experimental Study.,"Overcoming the impact of the coronavirus pandemic (COVID-19) on primary schools is an emerging need and priority in the current social welfare system. Accordingly, this study presents an empirical learning package to support teachers, who perform frontline work in schools, in coping with stress, preventing burnout, improving their information and communications technology (ICT) competency, and introducing the principles of emotional intelligence (EI) in the classroom. The participants included 141 primary school teachers (M = 38.4 years, SD = 6.84; 54.6% women). They were randomly assigned to an experimental or control group. The experimental group participated in the 14-week teacher training program, whereas the control group did not participate in the program or receive any other training during the intervention. Repeated-measures analysis of variance (time x group) was performed to identify the effects of the teacher training program. Teachers who participated in the training program evaluated it positively and showed significant differences compared to the control group in their abilities to cope with stress and avoid burnout, their ICT competency, and their introduction of EI in the classroom. Implications for supporting teachers are discussed.",2020,"Teachers who participated in the training program evaluated it positively and showed significant differences compared to the control group in their abilities to cope with stress and avoid burnout, their ICT competency, and their introduction of EI in the classroom.","['participants included 141 primary school teachers (M = 38.4 years, SD = 6.84; 54.6% women']","['14-week teacher training program', 'control group did not participate in the program or receive any other training during the intervention']",[],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],141.0,0.0122871,"Teachers who participated in the training program evaluated it positively and showed significant differences compared to the control group in their abilities to cope with stress and avoid burnout, their ICT competency, and their introduction of EI in the classroom.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pozo-Rico', 'Affiliation': 'Department of Developmental Psychology and Didactics, University of Alicante, 03080 Alicante, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gilar-Corbí', 'Affiliation': 'Department of Developmental Psychology and Didactics, University of Alicante, 03080 Alicante, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Developmental Psychology and Didactics, University of Alicante, 03080 Alicante, Spain.'}, {'ForeName': 'Juan-Luis', 'Initials': 'JL', 'LastName': 'Castejón', 'Affiliation': 'Department of Developmental Psychology and Didactics, University of Alicante, 03080 Alicante, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228633']
2098,33022148,Vocal music enhances memory and language recovery after stroke: pooled results from two RCTs.,"OBJECTIVE
Previous studies suggest that daily music listening can aid stroke recovery, but little is known about the stimulus-dependent and neural mechanisms driving this effect. Building on neuroimaging evidence that vocal music engages extensive and bilateral networks in the brain, we sought to determine if it would be more effective for enhancing cognitive and language recovery and neuroplasticity than instrumental music or speech after stroke.
METHODS
Using data pooled from two single-blind randomized controlled trials in stroke patients (N = 83), we compared the effects of daily listening to self-selected vocal music, instrumental music, and audiobooks during the first 3 poststroke months. Outcome measures comprised neuropsychological tests of verbal memory (primary outcome), language, and attention and a mood questionnaire performed at acute, 3-month, and 6-month stages and structural and functional MRI at acute and 6-month stages.
RESULTS
Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients. Voxel-based morphometry and resting-state and task-based fMRI results showed that vocal music listening selectively increased gray matter volume in left temporal areas and functional connectivity in the default mode network.
INTERPRETATION
Vocal music listening is an effective and easily applicable tool to support cognitive recovery after stroke as well as to enhance early language recovery in aphasia. The rehabilitative effects of vocal music are driven by both structural and functional plasticity changes in temporoparietal networks crucial for emotional processing, language, and memory.",2020,"RESULTS
Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients.","['after stroke', 'stroke patients (N\xa0=\xa083']","['Voxel-based morphometry and resting-state and task-based fMRI', 'vocal music listening', 'daily music listening', 'daily listening to self-selected vocal music, instrumental music, and audiobooks']","['gray matter volume in left temporal areas and functional connectivity', 'neuropsychological tests of verbal memory (primary outcome), language, and attention and a mood questionnaire performed at acute, 3-month, and 6-month stages and structural and functional MRI at acute and 6-month stages', 'Vocal music enhances memory and language recovery', 'verbal memory recovery']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.359863,"RESULTS
Listening to vocal music enhanced verbal memory recovery more than instrumental music or audiobooks and language recovery more than audiobooks, especially in aphasic patients.","[{'ForeName': 'Aleksi J', 'Initials': 'AJ', 'LastName': 'Sihvonen', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Leo', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ripollés', 'Affiliation': 'Department of Psychology, New York University, New York, New York.'}, {'ForeName': 'Terhi', 'Initials': 'T', 'LastName': 'Lehtovaara', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Ylönen', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Rajanaro', 'Affiliation': 'Private Music Therapy Practitioner, Turku, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Laitinen', 'Affiliation': 'Private Music Therapy Practitioner, Helsinki, Finland.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Forsblom', 'Affiliation': 'Private Music Therapy Practitioner, Helsinki, Finland.'}, {'ForeName': 'Jani', 'Initials': 'J', 'LastName': 'Saunavaara', 'Affiliation': 'Department of Medical Physics, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Taina', 'Initials': 'T', 'LastName': 'Autti', 'Affiliation': 'Department of Radiology, HUS Medical Imaging Center, Helsinki University Central Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Turku, Finland.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rodríguez-Fornells', 'Affiliation': ""Cognition and Brain Plasticity Group, Bellvitge Biomedical Research Institute, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Tervaniemi', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Seppo', 'Initials': 'S', 'LastName': 'Soinila', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurology, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Särkämö', 'Affiliation': 'Cognitive Brain Research Unit, Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51217']
2099,33022678,"Effect of Progressive Resistance Training on Circulating Adipogenesis-, Myogenesis-, and Inflammation-Related microRNAs in Healthy Older Adults: An Exploratory Study.","BACKGROUND
Functional and physiological adaptations induced by resistance training have been extensively studied in older adults. However, microRNA (miRNA) as the novel regulator in protective effects remains poorly understood.
OBJECTIVE
The purpose of an exploratory study was to analyze the response of a panel of circulating miRNAs to adaptations mediated by resistance training.
METHODS
Ten healthy older adults (age: 67.6 ± 2.2 years, 7 women and 3 men) without previous experience in resistance training were recruited. Blood samples were collected at baseline and after a 12-week resistance training. Next-generation sequencing was used to determine circulating miRNA responses to chronic resistance training.
RESULTS
After the 12-week training, physical functions including grip strength, lower body strength and endurance, and walking capacity were improved in the older adults, while the serum levels of leptin (from 18.1 ± 20.0 to 14.9 ± 17.6 ng/mL, p = 0.029) and tumor necrosis factor alpha (TNFα; from 4.4 ± 0.6 to 4.0 ± 0.6 pg/mL, p < 0.001) were significantly decreased. In addition, adipogenesis-related miRNAs (miR-103a-3p, -103b, -143-5p, -146b-3p, -146b-5p, -17-5p, -181a-2-3p, -181b-5p, -199a-5p, -204-3p, and -378c), anti-adipogenesis-related miRNAs (miR-155-3p, -448, and -363-3p), myogenesis-related miRNAs (miR-125b-1-3p, -128-3p, -133a-3p, 155-3p, -181a-2-3p, -181b-5p, -199a-5p, -223-3p, and -499a-5p), and inflammation-related miRNAs (miR-146b-3p, -146b-5p, -155-3p, -181a-2-3p, and -181b-5p) were changed significantly in the older adults after training (fold change >2, p < 0.05). The log2 fold change of miRNA-125-1-3p was inversely correlated with delta walking time (R = -0.685, p = 0.029) and change in insulin-like growth factor 1 (R = -0.644, p = 0.044).
CONCLUSIONS
Our results can help explain the link between specific circulating miRNAs and beneficial effects of resistance training on functional and physiological adaptations in older adults.",2020,"The log2 fold change of miRNA-125-1-3p was inversely correlated with delta walking time (R = -0.685, p = 0.029) and change in insulin-like growth factor 1","['older adults', 'Healthy Older Adults', 'Ten healthy older adults (age: 67.6 ± 2.2 years, 7 women and 3 men) without previous experience in resistance training were recruited']","['Progressive Resistance Training', 'resistance training']","['change in insulin-like growth factor 1', 'Blood samples', 'delta walking time', 'Circulating Adipogenesis-, Myogenesis-, and Inflammation-Related microRNAs', 'serum levels of leptin', 'physical functions including grip strength, lower body strength and endurance, and walking capacity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0596843', 'cui_str': 'Adipogenesis'}, {'cui': 'C0596997', 'cui_str': 'Myogenesis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",10.0,0.0248945,"The log2 fold change of miRNA-125-1-3p was inversely correlated with delta walking time (R = -0.685, p = 0.029) and change in insulin-like growth factor 1","[{'ForeName': 'Hung-Wen', 'Initials': 'HW', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan, hwliu@ntnu.edu.tw.'}, {'ForeName': 'Hao-Chien', 'Initials': 'HC', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Shun-Hsi', 'Initials': 'SH', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Hsien', 'Initials': 'WH', 'LastName': 'Sun', 'Affiliation': 'Department of Physical Education, National Taiwan Normal University, Taipei, Taiwan.'}]",Gerontology,['10.1159/000510148']
2100,33023771,"Re: Hiten D. Patel, Farzana A. Faisal, Bruce J. Trock, et al. Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial. Eur Urol 2020;78:360-8.",,2020,,[],"['Radical Prostatectomy', 'Pharmacologic Prophylaxis']",['Venous Thromboembolism'],[],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.0320834,,"[{'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Fankhauser', 'Affiliation': 'Department of Urology, University Hospital Zurich, University of Zurich, Zurich, Switzerland; Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Department of Urology, The Christie NHS Foundation Trusts, Manchester, UK. Electronic address: christian.fankhauser@usz.ch.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Parry', 'Affiliation': 'Clinical Effectiveness Unit, Royal College of Surgeons of England, London, UK; Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Noel W', 'Initials': 'NW', 'LastName': 'Clarke', 'Affiliation': 'Department of Urology, The Christie NHS Foundation Trusts, Manchester, UK; Department of Urology, Salford Royal NHS Foundation Trusts, Manchester, UK.'}]",European urology,['10.1016/j.eururo.2020.09.038']
2101,32967775,Effect of Icosapent Ethyl on Gynoid Fat and Bone Mineral Health in the Metabolic Syndrome: A Preliminary Report.,"PURPOSE
The metabolic syndrome (MetS) is a systemic disorder associated with reduced atheroprotective gynoid fat and bone mineral content (BMC). The goal of this pilot study was to assess whether administration of icosapent ethyl (IPE), a purified formulation of eicosapentaenoic acid, would maintain gynoid fat and BMC over a 9-month treatment period.
METHODS
Patients with MetS aged ≥40 years were randomly assigned to receive 4 g daily of IPE (2 g BID with food) or placebo (paraffin oil 2 g BID with food) for 9 months. Data were collected at baseline and 9 months later. The data included anthropometric measures, biochemical analysis, and whole body fat mass, including gynoid fat. Bone mineral density and BMC were measured by using dual-energy X-ray absorptiometry. A two-tailed P value ≤ 0.05 was considered statistically significant.
FINDINGS
The study sample consisted of 13 patients with MetS (mean age, 61.6 years; age range, 44-77 years; 77% female and 23% male). Compared with the IPE group, the placebo group experienced statistically significant mean reductions in percent gynoid fat (pre/post, 46.8%-43.5%; P = 0.02), BMC (pre/post, 2461 g-2423 g; P = 0.02), and bone mineral density (pre/post, 1.24 g/cm 2 to 1.22 g/cm 2 ; P = 0.05) over the 9-month study period.
IMPLICATIONS
The results of this pilot study raise the possibility that IPE supplementation may preserve gynoid fat distribution and bone mineral health in patients with MetS. Larger, randomized longitudinal studies are necessary to determine the potential long-term metabolic benefits of IPE treatment.",2020,"Compared with the IPE group, the placebo group experienced statistically significant mean reductions in percent gynoid fat (pre/post, 46.8%-43.5%; P = 0.02), BMC (pre/post, 2461 ","['g-2423', 'Metabolic Syndrome', '13 patients with MetS (mean age, 61.6 years; age range, 44-77 years; 77% female and 23% male', 'patients with MetS', 'Patients with MetS aged ≥40 years']","['icosapent ethyl (IPE', 'Icosapent Ethyl', 'placebo (paraffin oil 2', 'IPE supplementation', 'IPE', 'eicosapentaenoic acid', 'placebo']","['bone mineral density', 'BMC', 'Gynoid Fat and Bone Mineral Health', 'Bone mineral density and BMC', 'gynoid fat distribution and bone mineral health', 'percent gynoid fat']","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026156', 'cui_str': 'Mineral Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0424629', 'cui_str': 'Peripheral obesity'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",13.0,0.0814381,"Compared with the IPE group, the placebo group experienced statistically significant mean reductions in percent gynoid fat (pre/post, 46.8%-43.5%; P = 0.02), BMC (pre/post, 2461 ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mmiller@som.umaryland.edu.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA; Baltimore VA Geriatric Research, Education and Clinical Center, Baltimore, MD, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Reed', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Goggins', 'Affiliation': 'Department of Medicine, Georgetown University School of Medicine, Washington, DC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sorkin', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA; Baltimore VA Geriatric Research, Education and Clinical Center, Baltimore, MD, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA; Baltimore VA Geriatric Research, Education and Clinical Center, Baltimore, MD, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.09.005']
2102,32975679,"Effect of Empagliflozin on Liver Steatosis and Fibrosis in Patients With Non-Alcoholic Fatty Liver Disease Without Diabetes: A Randomized, Double-Blind, Placebo-Controlled Trial.","INTRODUCTION
Despite the high prevalence of non-alcoholic fatty liver disease (NAFLD) and its associated co-morbidities, no efficient treatment in a high percentage of individuals is available. Beneficial effects of sodium-glucose co-transporter 2 inhibitors on fatty liver have been investigated in people with type 2 diabetes (T2DM). The aim of this study was to explore the effect of empagliflozin on liver steatosis and fibrosis in patients with NAFLD without T2DM.
METHODS
In this prospective randomized, double-blind, placebo-controlled clinical trial, participants with NAFLD were randomized to empagliflozin (10 mg/day) (n = 43) or placebo (n = 47) for 24 weeks. Hepatic steatosis and fibrosis were assessed using transient elastography to measure the controlled attenuation parameter (CAP) and liver stiffness measurement (LSM). The primary outcome was the change in CAP score at 24 weeks.
RESULTS
There was significant decrease in CAP score in both groups but no significant difference was observed between the two groups (P = 0.396). LSM was significantly decreased in the empagliflozin-treated group (6.03 ± 1.40 to 5.33 ± 1.08 kPa; P = 0.001), while no change was found in the placebo group. In subgroups analysis of patients with significant steatosis at baseline (CAP ≥ 302 dB/m), steatosis significantly improved in the empagliflozin group (37.2% vs. 17%; P = 0.035). There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
CONCLUSIONS
Empagliflozin improves liver steatosis and, more importantly, measures of liver fibrosis in patients with NAFLD without T2DM.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, IRCT20190122042450N1.",2020,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","['people with type\xa02 diabetes (T2DM', 'Without Diabetes', 'participants with NAFLD', '302\xa0dB/m', 'Patients With Non-Alcoholic Fatty Liver Disease', 'patients with NAFLD without T2DM', 'patients with significant steatosis at baseline (CAP\u2009≥']","['empagliflozin', 'placebo', 'sodium-glucose co-transporter\xa02 inhibitors', 'Empagliflozin', 'Placebo']","['change in CAP score', 'controlled attenuation parameter (CAP) and liver stiffness measurement (LSM', 'Hepatic steatosis and fibrosis', 'grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels', 'Liver Steatosis and Fibrosis', 'LSM', 'liver fibrosis', 'liver steatosis and fibrosis', 'liver steatosis', 'CAP score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}]",,0.63044,"There was a significant decrease in the grade of liver fat on visual analysis of ultrasound images, AST, ALT, and fasting insulin levels in the empagliflozin group, while no changes were observed in the placebo group.
","[{'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Malek', 'Affiliation': 'Research Center for Prevention of Cardiovascular Disease, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran. malek.m@iums.ac.ir.'}, {'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Ismail-Beigi', 'Affiliation': 'Department of Medicine, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, 44106, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Zamani', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Masoudreza', 'Initials': 'M', 'LastName': 'Sohrabi', 'Affiliation': 'Gastrointestinal and Liver Disease Research Center, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Reza Babaei', 'Affiliation': 'Department of Interventional Radiology, Firouzgar Hospital, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Mohammad E', 'Initials': 'ME', 'LastName': 'Khamseh', 'Affiliation': 'Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Advances in therapy,['10.1007/s12325-020-01498-5']
2103,32971314,Quality of life after response to acute-phase cognitive therapy for recurrent depression.,"BACKGROUND
Adults with major depressive disorder (MDD) often experience reduced quality of life (QOL). Efficacious acute-phase treatments, including cognitive therapy (CT) or medication, decrease depressive symptoms and, to a lesser degree, increase QOL. We tested longer-term changes in QOL after response to acute-phase CT, including the potential effects of continuation treatment for depression and time-lagged relations between QOL and depressive symptoms.
METHODS
Responders to acute-phase CT (N = 290) completed QOL and depressive symptom assessments repeatedly for 32 post-acute months. Higher-risk responders were randomized to 8 months of continuation treatment (CT, fluoxetine, or pill placebo) and then entered a 24-month follow-up. Lower-risk responders were only assessed for 32 months.
RESULTS
On average, large gains in QOL made during acute-phase CT response were maintained for 32 months. Continuation CT or fluoxetine did not improve QOL relative to pill placebo. Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence. Higher QOL predicted subsequent reductions in depressive symptom severity, but depressive symptom severity did not predict subsequent changes in QOL.
LIMITATIONS
Generalization of results to other patient populations, treatments, and measures is uncertain. The clinical trial was not designed to test relations between QOL and depression. Replication is needed before clinical application of these results.
CONCLUSIONS
Gains in QOL made during response to acute-phase CT are relatively stable and may help protect against relapse/recurrence. Continuation CT or fluoxetine may not further improve QOL among acute-phase CT responders.",2021,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","['Responders to acute-phase CT', 'Adults with major depressive disorder (MDD', 'recurrent depression', 'Higher-risk responders']","['cognitive therapy (CT', 'continuation treatment (CT, fluoxetine, or pill placebo', 'fluoxetine']","['QOL relative', 'depressive symptom severity', 'quality of life (QOL', 'QOL and depressive symptom assessments', 'QOL', 'Quality of life']","[{'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",290.0,0.0234422,"Controlling for residual depressive symptoms, higher QOL after acute-phase CT response was a protective factor against MDD relapse and recurrence.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Department of Psychology, Truman State University, 100 East Normal Street, Kirksville, MO 63501-4221, USA. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Population and Data Sciences, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9149, USA. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.059']
2104,32971388,Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults.,"BACKGROUND
Cannabis warning labels can communicate risks, but there is little research on warning perceptions and differences by product type.
METHODS
In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco) were randomly assigned to view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis. The warnings described cannabis risks related to psychosis, addiction, lack of FDA oversight, and impaired driving. We used linear regression to examine perceptions of warnings and product harm as a function of product type (dried or edible) and warning. We examined which warning participants selected as most effective for discouraging youth use and impaired driving.
RESULTS
Participants found the addiction warning (cannabis users: B = -1.04, p < 0.001; cannabis non-users: B = 1.17, p < 0.001) and psychosis warning (users: B = -0.65, p < 0.05; non-users: B = -0.71, p < 0.05) less believable than the driving warning but indicated that they learned more from the psychosis warning than the driving warning (users: B = 0.88, p < 0.01; non-users (B = 1.60, p < 0.001). Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05). The psychosis warning was most frequently selected as the best warning for discouraging youth use.
CONCLUSIONS
Warnings have the potential to educate consumers and impact cannabis harm perceptions. Warnings have similar effects across product types, potentially eliminating the need for product type-specific warnings. The association of cannabis use with risk for psychosis, a topic addressed in Canadian warnings, could be a useful topic of focus in U.S. warnings.",2020,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"['In a 2019 online survey, 1,000 U.S. adults (500 cannabis users and 500 cannabis non-users who used tobacco', 'Perceptions of U.S. and Canadian Cannabis Package Warnings Among U.S. Adults']",['view no warning or one of four U.S. or Canadian warnings displayed on images of packaging for dried flower or edible cannabis'],"['addiction warning', 'psychosis warning']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0556574', 'cui_str': 'Dried flowers'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]",,0.0480856,Participants viewing any warning considered smoking cannabis to be more harmful than those viewing no warning (all p < 0.05).,"[{'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA. Electronic address: jpepper@rti.org.'}, {'ForeName': 'Youn Ok', 'Initials': 'YO', 'LastName': 'Lee', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Eggers', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Allen', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Nonnemaker', 'Affiliation': 'Center for Health Policy Science & Tobacco Research, RTI International, 3040 E. Cornwallis Rd., Research Triangle Park, NC, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108275']
2105,32979417,Serum lipids and their association with birth weight in metformin and insulin treated patients with gestational diabetes.,"AIMS
To compare the effects of metformin and insulin treatment on maternal serum lipids in patients with gestational diabetes (GDM), and to analyse the associations between individual lipids and birth weight (BW).
METHODS
This is a secondary analysis of a randomized trial comparing metformin (n = 110) and insulin (n = 107) treatment of GDM. Fasting serum lipidome was measured at baseline (the time of diagnosis, mean 30 gestational weeks, gw) and at 36 gw using nuclear magnetic resonance spectroscopy.
RESULTS
Total and VLDL triglycerides, and VLDL cholesterol increased from baseline to 36 gw in both treatment groups. The rise in triglycerides was greater in the metformin treated patients (p < 0.01). Baseline total and VLDL triglycerides, VLDL cholesterol, and apolipoprotein B to A-1 ratio (apoB/apoA-1) associated positively with BW, more strongly in the metformin group. Among patients in the highest baseline VLDL cholesterol or apoB/apoA-1 quartile, those treated with insulin had lower BWs than those treated with metformin (p < 0.03).
CONCLUSION
Compared to insulin, metformin treatment of GDM led to higher maternal serum concentrations of triglyceride-rich lipoproteins. Especially triglycerides and cholesterol in VLDL were positively associated with BW. Women with high VLDL cholesterol or high apoB/apoA-1 may benefit from insulin treatment over metformin with respect to offspring BW.",2020,The rise in triglycerides was greater in the metformin treated patients (p<0.01).,"['treated patients with gestational diabetes', 'patients with gestational diabetes (GDM', 'Women with high VLDL cholesterol or high apoB/apoA-1']","['metformin and insulin treatment', 'metformin', 'insulin, metformin', 'metformin and insulin', 'GDM']","['maternal serum concentrations of triglyceride-rich lipoproteins', 'Fasting serum lipidome', 'rise in triglycerides', 'Total and VLDL triglycerides and VLDL cholesterol', 'Especially triglycerides and cholesterol in VLDL', 'Serum lipids and their association with birth weight', 'individual lipids and birth weight (BW', 'Baseline total and VLDL triglycerides and VLDL cholesterol, and apolipoprotein B to A-1 ratio (apoB/apoA-1', 'maternal serum lipids']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C4727084', 'cui_str': 'Lipidome'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078207', 'cui_str': 'Very low density lipoprotein triglyceride'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}]",,0.0260123,The rise in triglycerides was greater in the metformin treated patients (p<0.01).,"[{'ForeName': 'Mikael S', 'Initials': 'MS', 'LastName': 'Huhtala', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014 Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland. Electronic address: misahu@utu.fi.'}, {'ForeName': 'Kristiina', 'Initials': 'K', 'LastName': 'Tertti', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Turku, 20014 Turku, Finland; Department of Obstetrics and Gynecology, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland.'}, {'ForeName': 'Tapani', 'Initials': 'T', 'LastName': 'Rönnemaa', 'Affiliation': 'Department of Medicine, University of Turku, 20014 Turku, Finland; Department of Medicine, Turku University Hospital, Kiinamyllynkatu 4-8, 20521 Turku, Finland.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108456']
2106,32985775,Withdrawal of medications leads to worsening of OGTT parameters in youth with impaired glucose tolerance or recently-diagnosed type 2 diabetes.,"BACKGROUND
The RISE Pediatric Medication Study compared strategies for preserving β-cell function, including a 9-month follow-up after treatment withdrawal to test treatment effect durability.
OBJECTIVE
Evaluate OGTT measures of glucose and β-cell response through 12 months of intervention and 9 months of medication washout.
PARTICIPANTS
Youth (n = 91) aged 10 to 19 years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D).
METHODS
A multicenter randomized clinical trial comparing insulin glargine for 3 months followed by metformin for 9 months (G→Met) or metformin alone (Met) for 12 months. We report within-group changes from baseline to end of medication intervention (M12), baseline to 9 months post-medication withdrawal (M21), and end of medication (M12) to M21. OGTT C-peptide index [CPI] paired with 1/fasting insulin evaluated β-cell response.
RESULTS
At M12, both treatments were associated with stable fasting glucose (G→Met baseline 6.0 ± 0.1 vs M12 5.9 ± 0.2 mmol/L, P = .62; Met baseline 6.1 ± 0.2 vs M12 6.0 ± 0.2 mmol/L, P = .73) and 2-hour glucose (G→Met baseline 10.2 ± 0.4 vs M12 9.3 ± 0.5 mmol/L, P = .03; Met baseline 10.2 ± 0.4 vs M12 10.6 ± 0.6 mmol/L, P = .88). Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6 ± 1.8, P = .004; Met M21 7.8 ± 0.7 mmol/L, P = .003), as did 2-hour glucose (G→Met M21 13.2 ± 1.4, P = .002; Met M21 13.1 ± 1.2 mmol/L, P = .006), associated with declines in β-cell response.
CONCLUSIONS
G→Met and Met were associated with stable glucose measures during 12 months of treatment in youth with IGT or recently diagnosed T2D. Glucose and β-cell response worsened post-medication withdrawal, suggesting treatment must be long-term or alternative treatments pursued.",2020,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","['Youth (n=91) aged 10-19\u2009years with BMI ≥85th percentile and impaired glucose tolerance (IGT) or recently diagnosed type 2 diabetes (T2D', 'Youth with Impaired Glucose Tolerance or Recently-Diagnosed Type 2 Diabetes']","['insulin glargine', 'metformin']","['stable fasting glucose', 'fasting glucose', 'glucose and β-cell response', 'stable glucose measures', 'β-cell response']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",91.0,0.022497,"Following medication withdrawal, fasting glucose worsened (G→Met M21 8.6±1.8, p=0.004; Met M21 7.8±0.7 mmol/L, p=0.003), as did 2-hour glucose (G→Met M21 13.2±1.4, p=0.002; Met M21 13.1±1.2 mmol/L, p=0.006), associated with declines in β-cell response.
","[{'ForeName': 'Tamara S', 'Initials': 'TS', 'LastName': 'Hannon', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Edelstein', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, Maryland, USA.'}, {'ForeName': 'Silva A', 'Initials': 'SA', 'LastName': 'Arslanian', 'Affiliation': ""University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Caprio', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Philip S', 'Initials': 'PS', 'LastName': 'Zeitler', 'Affiliation': ""University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Buchanan', 'Affiliation': 'University of Southern California, Keck School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ehrmann', 'Affiliation': 'University of Chicago, Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tripputi', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, Maryland, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'VA Puget Sound Health Care System and University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'Nadeau', 'Affiliation': ""University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13129']
2107,32980364,PROVIDE-HF primary results: Patient-Reported Outcomes inVestigation following Initiation of Drug therapy with Entresto (sacubitril/valsartan) in heart failure.,"BACKGROUND
In PARADIGM-HF, sacubitril/valsartan improved quality of life (QOL) versus enalapril in heart failure with reduced ejection fraction (HFrEF), yet limited data are available regarding QOL changes after sacubitril/valsartan initiation in routine practice.
METHODS
PROVIDE-HF was a prospective study within a national research network (Patient-Centered Outcomes Research Network) of HFrEF outpatients recently initiated on sacubitril/valsartan versus controls with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change. The primary end point was mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12 weeks. Other end points included responder analyses: ≥5-point and ≥20-point KCCQ increase. Adjusted QOL change was estimated after propensity score weighting.
RESULTS
Overall, 270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control). The groups had similar demographics and HF details: median EF 28% and N-terminal pro-brain natriuretic peptide 1083 pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference +4.76; P = .027) and were more likely to have a ≥5-point and ≥20-point response (all P < .05). Adjusted comparisons demonstrated similar numerical improvements in the change in KCCQ (+4.55; 95% CI -0.89 to 9.99; P = .101) and likelihood of ≥5-point increase (odds ratio 1.55; 95% CI: 0.84-2.86; P = .16); ≥20-point increase remained statistically significant (odds ratio 3.79; 95% CI 1.47-9.73; P = .006).
CONCLUSIONS
In this prospective HFrEF study of sacubitril/valsartan initiation compared with recent angiotensin-converting enzyme inhibitor/angiotensin receptor blocker initiation/dose change, the between-group difference in the primary end point, mean KCCQ change at 12 weeks was not statistically significant following adjustment, but sacubitril/valsartan initiation was associated with early improvements in QOL and a higher likelihood of ≥20-point improvement in KCCQ at 12 weeks. These data add additional real-world evidence related to patient-reported outcomes following the initiation of sacubitril/valsartan in routine clinical practice.",2020,The groups had similar demographics and HF details: median EF 28% and NT-proBNP 1083pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference+4.76; P=.027) and were more likely to have a≥5-point and≥20-point response (all P<.05).,"['PROVIDE-HF was a prospective study within a national research network (PCORnet) of HFrEF outpatients', '270 patients had both baseline and 12-week KCCQ data (151 sacubitril/valsartan; 119 control', 'heart failure']","['sacubitril/valsartan', 'Entresto (Sacubitril/valsartan', 'sacubitril/valsartan vs. controls with recent ACE-I/ARB initiation/dose change', 'enalapril']","['quality of life (QOL', 'mean KCCQ change', 'KCCQ', 'Adjusted QOL change', 'mean Kansas City Cardiomyopathy Questionnaire (KCCQ) change through 12weeks']","[{'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}]",270.0,0.117334,The groups had similar demographics and HF details: median EF 28% and NT-proBNP 1083pg/mL. Sacubitril/valsartan patients had larger improvements in KCCQ (mean difference+4.76; P=.027) and were more likely to have a≥5-point and≥20-point response (all P<.05).,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Duke University School of Medicine, Durham, NC. Electronic address: robert.mentz@duke.edu.'}, {'ForeName': 'Haolin', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Laine', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Alexy', 'Affiliation': 'University of Minnesota Health, Minneapolis, MN.'}, {'ForeName': 'Bhanu', 'Initials': 'B', 'LastName': 'Gupta', 'Affiliation': 'University of Kansas Medical Center, Kansas City, KS.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Vilaro', 'Affiliation': 'University of Florida, Gainesville, FL.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Dhingra', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Briasoulis', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Simon', 'Affiliation': 'Pittsburgh Heart, Lung, Blood and Vascular Medicine Institute, McGowan Institute for Regenerative Medicine, Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Stehlik', 'Affiliation': 'University of Utah School of Medicine, Salt Lake City, UT.'}, {'ForeName': 'Jo E', 'Initials': 'JE', 'LastName': 'Rodgers', 'Affiliation': 'UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Dunlay', 'Affiliation': 'Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Abshire', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, MD.'}, {'ForeName': 'Quinn S', 'Initials': 'QS', 'LastName': 'Wells', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Kurt G', 'Initials': 'KG', 'LastName': 'Barringhaus', 'Affiliation': 'University of South Carolina School of Medicine and WJB Dorn Veteran Affairs Medical Center, Columbia, SC.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Eckman', 'Affiliation': 'Minneapolis Heart Institute; Minneapolis, MN.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Lowes', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Johana', 'Initials': 'J', 'LastName': 'Espinoza', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Blanco', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC; Duke University School of Medicine, Durham, NC.'}]",American heart journal,['10.1016/j.ahj.2020.09.012']
2108,32981043,"A Randomized, Double-Dummy, Emergency Department-Based Study of Greater Occipital Nerve Block With Bupivacaine vs Intravenous Metoclopramide for Treatment of Migraine.","BACKGROUND
Greater occipital nerve blocks (GONB) are used increasingly to treat acute migraine.
OBJECTIVE
We conducted a randomized controlled trial to determine whether GONB was as effective as intravenous metoclopramide for migraine.
METHODS
This was a double-dummy, double-blind, parallel-arm, non-inferiority study conducted in 2 emergency departments (EDs). Patients with migraine of moderate or severe intensity were randomized to receive bilateral GONB with each side administered 3 mL of bupivacaine 0.5% or metoclopramide 10 mg IV, the putative standard of care. The primary outcome was improvement in pain on a 0-10 scale between time 0 and 1 hour later. To reject the null hypothesis that metoclopramide would be more efficacious in relieving pain, we required that the lower limit of the 95% CI for the difference in pain improvement between those randomized to GONB vs those randomized to metoclopramide be >-1.3, a validated minimum clinically important difference. Secondary outcomes included sustained headache relief, defined as achieving and maintaining for 48 hours a headache level of mild or none without the use of additional analgesic medication, and the use of rescue medication in the ED.
RESULTS
Over a 2.5-year study period, 1358 patients were screened for participation and 99 were randomized, 51 to GONB and 48 to metoclopramide. All of these patients were included in the primary analysis. Patients who received the GONB reported mean improvement of 5.0 (95% CI: 4.1, 5.8) while those who received metoclopramide reported a larger mean improvement of 6.1 (95% CI: 5.2, 6.9). The 95% CI for the between group difference of -1.1 was -2.3, 0.1. Sustained headache relief was reported by 11/51 (22%) GONB and 18/47 (38%) metoclopramide patients (95% CI for rounded difference of 17%: -1, 35%). Of the 51 GONB patients, 17 (33%) required rescue medication in the ED vs 8/48 (17%) metoclopramide patients (95% CI for rounded difference of 17%: 0, 33%). An adverse event was reported by 16/51 (31%) GONB patients and 18/48 (38%) metoclopramide patients (95% CI for (rounded) difference of 6%: -13, 25%).
CONCLUSION
GONB with bupivacaine was not as efficacious as IV metoclopramide for the first-line treatment of migraine in the ED.",2020,"The 95% CI for the between group difference of -1.1 was -2.3, 0.1.","['Patients with migraine of moderate or severe intensity', '1358 patients were screened for participation and 99 were randomized, 51 to GONB and 48 to', '2 emergency departments (EDs']","['bupivacaine', 'GONB', 'Bupivacaine vs Intravenous Metoclopramide', 'metoclopramide', 'bilateral GONB with each side administered 3\xa0mL of bupivacaine 0.5% or metoclopramide']","['rescue medication', 'pain on a 0-10 scale between time 0 and 1\xa0hour later', 'sustained headache relief, defined as achieving and maintaining for 48\xa0hours a headache level of mild or none without the use of additional analgesic medication, and the use of rescue medication in the ED', 'adverse event', 'relieving pain', 'Sustained headache relief', 'pain improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0394692', 'cui_str': 'Injection of anesthetic agent into greater occipital nerve'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0394692', 'cui_str': 'Injection of anesthetic agent into greater occipital nerve'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",1358.0,0.637252,"The 95% CI for the between group difference of -1.1 was -2.3, 0.1.","[{'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Eddie', 'Initials': 'E', 'LastName': 'Irizarry', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Williams', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Clemencia', 'Initials': 'C', 'LastName': 'Solorzano', 'Affiliation': 'Pharmacy Department, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Zias', 'Affiliation': 'Pharmacy Department, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Robbins', 'Affiliation': 'Department of Neurology, Weill Cornell Medicine, New York-Presbyterian, New York, NY, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Harrilal', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Del Valle', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'Polly E', 'Initials': 'PE', 'LastName': 'Bijur', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Gallagher', 'Affiliation': 'Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore, Bronx, NY, USA.'}]",Headache,['10.1111/head.13961']
2109,32992190,Dual Antiplatelet Therapy Beyond 90 days in Symptomatic Intracranial Stenosis in the SAMMPRIS Trial.,"BACKGROUND
The safety and efficacy of dual antiplatelet use for symptomatic intracranial atherosclerosis beyond 90 days is unknown. Data from SAMMPRIS was used to determine if dual antiplatelet therapy (DAPT) beyond 90 days impacted the risk of ischemic stroke and hemorrhage.
METHODS
This post hoc exploratory analysis from SAMMPRIS included patients who did not have a primary endpoint within 90 days after enrollment (n = 397). Patients in both the aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS) arms were included. Baseline features and outcomes during follow-up were compared between patients who remained on DAPT beyond 90 days (on clopidogrel) and patients who discontinued clopidogrel and remained on aspirin alone at 90 days (off clopidogrel) using Fisher's exact tests.
RESULTS
The stroke rate was numerically lower in the group on clopidogrel vs off clopidogrel among both the AMM alone arm (6.0% versus 10.8%, p = 0.31) and the PTAS arm (8.7% versus 9.8%; p = 0.82), but the difference was not significant. The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
CONCLUSION
This exploratory analysis suggests that prolonged DAPT use may lower the risk of stroke in medically treated patients with intracranial stenosis but may increase the risk of major hemorrhage.",2020,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
",['patients who did not have a primary endpoint within 90 days after enrollment (n\xa0=\xa0397'],"['aggressive medical management (AMM) and percutaneous transluminal angioplasty and stenting (PTAS', 'Dual Antiplatelet Therapy', 'clopidogrel', 'aspirin']","['stroke rate', 'major hemorrhage rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",397.0,0.0576875,"The major hemorrhage rates were numerically higher in the group on clopidogrel vs. off clopidogrel group among both the AMM alone arm (4.0% versus 2.5%; p = 0.67) and the PTAS arm (10.9% versus 3.5%; p = 0.08), but were not significant.
","[{'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Abdul Rahman', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: abdulara@musc.edu.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: turan@musc.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Department of Biostatistics and Bioinformatics, 1518 Clifton Rd, Emory University Rollins School of Public Health, Atlanta 30322, GA, United States. Electronic address: gcotson@emory.edu.'}, {'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Holmstedt', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: holmsted@musc.edu.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, 96 Jonathan Lucas Street, Clinical Science Building 301, MSC 606, Medical University of South Carolina, Charleston 29425-8050, SC, United States. Electronic address: mchimow@musc.edu.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105254']
2110,32998111,"Short-Term, Combined Fasting and Exercise Improves Body Composition in Healthy Males.","Fasting enhances the beneficial metabolic outcomes of exercise; however, it is unknown whether body composition is favorably modified on the short term. A baseline-follow-up study was carried out to assess the effect of an established protocol involving short-term combined exercise with fasting on body composition. One hundred seven recreationally exercising males underwent a 10-day intervention across 15 fitness centers in the Netherlands involving a 3-day gradual decrease of food intake, a 3-day period with extremely low caloric intake, and a gradual 4-day increase to initial caloric intake, with daily 30-min submaximal cycling. Using dual-energy X-ray absorptiometry analysis, all subjects substantially lost total body mass (-3.9 ± 1.9 kg; p < .001) and fat mass (-3.3 ± 1.3 kg; p < .001). Average lean mass was lost (-0.6 ± 1.5 kg; p < .001), but lean mass as a percentage of total body mass was not reduced. The authors observed a loss of -3.9 ± 1.9% android fat over total fat mass (p < .001), a loss of -2.2 ± 1.9% gynoid over total fat mass (p < .001), and reduced android/gynoid ratios (-0.05 ± 0.1; p < .001). Analyzing 15 preselected single-nucleotide polymorphisms in 13 metabolism-related genes revealed trending associations for thyroid state-related single-nucleotide polymorphisms rs225014 (deiodinase 2) and rs35767 (insulin-like growth factor1), and rs1053049 (PPARD). In conclusion, a short period of combined fasting and exercise leads to a substantial loss of body and fat mass without a loss of lean mass as a percentage of total mass.",2020,"Average lean mass was lost (-0.6 ± 1.5 kg; p < .001), but lean mass as a percentage of total body mass was not reduced.","['Healthy Males', 'One hundred seven recreationally exercising males']","['10-day intervention across 15 fitness centers in the Netherlands involving a 3-day gradual decrease of food intake, a 3-day period with extremely low caloric intake, and a gradual 4-day increase to initial caloric intake, with daily 30-min submaximal cycling', 'Combined Fasting and Exercise']","['total fat mass', 'total body mass', 'Average lean mass']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]",,0.0640488,"Average lean mass was lost (-0.6 ± 1.5 kg; p < .001), but lean mass as a percentage of total body mass was not reduced.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Delli Paoli', 'Affiliation': 'Università degli Studi della Campania ""Luigi Vanvitelli"".'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'van de Laarschot', 'Affiliation': 'European Consortium for Lifestyle, Exercise, Adaptation, and Nutrition (EULEAN).'}, {'ForeName': 'Edith C H', 'Initials': 'ECH', 'LastName': 'Friesema', 'Affiliation': 'European Consortium for Lifestyle, Exercise, Adaptation, and Nutrition (EULEAN).'}, {'ForeName': 'Remco', 'Initials': 'R', 'LastName': 'Verkaik', 'Affiliation': 'European Consortium for Lifestyle, Exercise, Adaptation, and Nutrition (EULEAN).'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Giacco', 'Affiliation': 'European Consortium for Lifestyle, Exercise, Adaptation, and Nutrition (EULEAN).'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Senese', 'Affiliation': 'Università degli Studi della Campania ""Luigi Vanvitelli"".'}, {'ForeName': 'Pascal P', 'Initials': 'PP', 'LastName': 'Arp', 'Affiliation': 'Erasmus University Medical Center.'}, {'ForeName': 'P Mila', 'Initials': 'PM', 'LastName': 'Jhamai', 'Affiliation': 'Erasmus University Medical Center.'}, {'ForeName': 'Stefano M', 'Initials': 'SM', 'LastName': 'Pagnotta', 'Affiliation': 'Università degli Studi del Sannio.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Broer', 'Affiliation': 'Erasmus University Medical Center.'}, {'ForeName': 'André G', 'Initials': 'AG', 'LastName': 'Uitterlinden', 'Affiliation': 'European Consortium for Lifestyle, Exercise, Adaptation, and Nutrition (EULEAN).'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Lanni', 'Affiliation': 'Università degli Studi della Campania ""Luigi Vanvitelli"".'}, {'ForeName': 'M Carola', 'Initials': 'MC', 'LastName': 'Zillikens', 'Affiliation': 'European Consortium for Lifestyle, Exercise, Adaptation, and Nutrition (EULEAN).'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'de Lange', 'Affiliation': 'Università degli Studi della Campania ""Luigi Vanvitelli"".'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0058']
2111,33233566,Effect of High-Dose vs Standard-Dose Vitamin D 3 Supplementation on Body Composition among Patients with Advanced or Metastatic Colorectal Cancer: A Randomized Trial.,"Skeletal muscle and adipose tissue express the vitamin D receptor and may be a mechanism through which vitamin D supplementation slows cancer progression and reduces cancer death. In this exploratory analysis of a double-blind, multicenter, randomized phase II clinical trial, 105 patients with advanced or metastatic colorectal cancer who were receiving chemotherapy were randomized to either high-dose vitamin D 3 (4000 IU) or standard-dose (400 IU) vitamin D 3 . Body composition was measured with abdominal computed tomography at enrollment (baseline) and after cycle 8 of chemotherapy (16 weeks). As compared with standard-dose vitamin D 3 , high-dose vitamin D 3 did not significantly change body weight [-0.7 kg; (95% CI: -3.5, 2.0)], body mass index [-0.2 kg/m 2 ; (95% CI: -1.2, 0.7)], muscle area [-1.7 cm 2 ; (95% CI: -9.6, 6.3)], muscle attenuation [-0.4 HU; (95% CI: -4.2, 3.2)], visceral adipose tissue area [-7.5 cm 2 ; (95% CI: -24.5, 9.6)], or subcutaneous adipose tissue area [-8.3 cm 2 ; (95% CI: -35.5, 18.9)] over the first 8 cycles of chemotherapy. Among patients with advanced or metastatic colorectal cancer, the addition of high-dose vitamin D 3 , vs standard-dose vitamin D 3 , to standard chemotherapy did not result in any changes in body composition.",2020,"As compared with standard-dose vitamin D 3 , high-dose vitamin D 3 did not significantly change body weight [-0.7 kg; (95% CI: -3.5, 2.0)], body mass index [-0.2 kg/m 2 ; (95% CI: -1.2, 0.7)], muscle area [-1.7 cm 2 ; (95% CI: -9.6, 6.3)], muscle attenuation [-0.4 HU; (95% CI: -4.2, 3.2)], visceral adipose tissue area [-7.5 cm 2 ; (95% CI: -24.5, 9.6)], or subcutaneous adipose tissue area [-8.3 cm 2 ; (95% CI: -35.5, 18.9)] over the first 8 cycles of chemotherapy.","['Patients with Advanced or Metastatic Colorectal Cancer', 'patients with advanced or metastatic colorectal cancer', '105 patients with advanced or metastatic colorectal cancer who were receiving chemotherapy']","['vitamin D supplementation', 'high-dose vitamin D 3 (4000 IU) or standard-dose (400 IU) vitamin D 3 ', 'High-Dose vs Standard-Dose Vitamin D 3 Supplementation']","['subcutaneous adipose tissue area', 'body composition', 'visceral adipose tissue area', 'change body weight', 'body mass index', 'Body composition', 'Body Composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",105.0,0.696289,"As compared with standard-dose vitamin D 3 , high-dose vitamin D 3 did not significantly change body weight [-0.7 kg; (95% CI: -3.5, 2.0)], body mass index [-0.2 kg/m 2 ; (95% CI: -1.2, 0.7)], muscle area [-1.7 cm 2 ; (95% CI: -9.6, 6.3)], muscle attenuation [-0.4 HU; (95% CI: -4.2, 3.2)], visceral adipose tissue area [-7.5 cm 2 ; (95% CI: -24.5, 9.6)], or subcutaneous adipose tissue area [-8.3 cm 2 ; (95% CI: -35.5, 18.9)] over the first 8 cycles of chemotherapy.","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rosenthal', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Halla S', 'Initials': 'HS', 'LastName': 'Nimeiri', 'Affiliation': 'Division of Hematology Oncology, Department of Medicine, Northwestern University, Chicago, IL 60611, USA.'}, {'ForeName': 'Nadine J', 'Initials': 'NJ', 'LastName': 'McCleary', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Abrams', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Yurgelun', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cleary', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Rubinson', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schrag', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Bullock', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zuckerman', 'Affiliation': ""St Luke's Mountain States Tumor Institute, Boise, ID 83712, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN 37232, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Chan', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wolpin', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Constantine', 'Affiliation': 'Dana-Farber at Milford Regional Medical Center, Milford, MA 01757, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Weckstein', 'Affiliation': 'New Hampshire Oncology Hematology, Hookset, NH 03106, USA.'}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Faggen', 'Affiliation': 'Dana-Farber at South Shore Hospital, South Weymouth, MA 02190, USA.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Thomas', 'Affiliation': 'New England Cancer Specialists, Scarborough, ME 04074, USA.'}, {'ForeName': 'Chryssanthi', 'Initials': 'C', 'LastName': 'Kournioti', 'Affiliation': 'Newton-Wellesley Hospital, Newton, MA 02462, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Massachusetts General Hospital, Boston, MA 02114, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Department of Medicine, Medical University of South Carolina, Charleston, SC 29425, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center, New Haven, CT 06510, USA.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA 02115, USA.'}]",Cancers,['10.3390/cancers12113451']
2112,33233656,The Impact of a Household Food Garden Intervention on Food Security in Lesotho.,"Food insecurity is a challenge in the developing world, where many are finding healthy food inaccessible due to poverty. A pre-test, post-test design was applied to determine the impact of a vegetable gardening intervention in 25 experimental and 25 control households in Lesotho. Information about sociodemographic conditions and indicators of food security was collected by trained fieldworkers. As evidenced by the Living Poverty Index of 2.5, the sample was characterized by high levels of poverty. Although almost no households were scored very low or low using the Months of Adequate Household Food Provisioning (MAHFP) tool, less than half of households were categorized as food-secure. Household Dietary Diversity (HDD) showed infrequent intake of vegetables and fruits and regular intake of fats and sugar. After intervention, the percentage of households with a low HDD score improved significantly in the intervention group (12%) compared to the control group (40%) (95% CI (2.5%; 50.7%)). Despite this, the percentage of households that consumed vegetables during the previous day was still below 30%. Food gardens have the potential to improve availability of food and frequency of vegetable consumption, but harsh environmental conditions need to be considered.",2020,"After intervention, the percentage of households with a low HDD score improved significantly in the intervention group (12%) compared to the control group (40%) (95% CI (2.5%; 50.7%)).","['25 experimental and 25 control households in Lesotho', 'Food Security in Lesotho']","['vegetable gardening intervention', 'Household Food Garden Intervention']",['percentage of households with a low HDD score'],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C3178753', 'cui_str': 'Food Security'}]","[{'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0252333,"After intervention, the percentage of households with a low HDD score improved significantly in the intervention group (12%) compared to the control group (40%) (95% CI (2.5%; 50.7%)).","[{'ForeName': 'Corinna May', 'Initials': 'CM', 'LastName': 'Walsh', 'Affiliation': 'Department of Nutrition and Dietetics, University of the Free State, Bloemfontein 9301, South Africa.'}, {'ForeName': 'Michelle Shannon', 'Initials': 'MS', 'LastName': 'Fouché', 'Affiliation': 'Department of Nutrition and Dietetics, University of the Free State, Bloemfontein 9301, South Africa.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Nel', 'Affiliation': 'Department of Biostatistics, University of the Free State, Bloemfontein 9301, South Africa.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Booysen', 'Affiliation': 'School of Economics and Finance, University of the Witwatersrand, Johannesburg 2000, South Africa.'}]",International journal of environmental research and public health,['10.3390/ijerph17228625']
2113,33003972,Long-Term Outcome of the Randomized DAPA Trial.,"BACKGROUND
The randomized DAPA trial (Defibrillator After Primary Angioplasty) aimed to evaluate the survival benefit of prophylactic implantable cardioverter defibrillator (ICD) implantation in early selected high-risk patients after primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction.
METHODS
A randomized, multicenter, controlled trial compared ICD versus conventional medical therapy in high-risk patients with primary percutaneous coronary intervention, based on one of the following factors: left ventricular ejection fraction <30% within 4 days after ST-segment-elevation myocardial infarction, primary ventricular fibrillation, Killip class ≥2 or TIMI (Thrombolysis in Myocardial Infarction) flow <3 after percutaneous coronary intervention. ICD was implanted 30 to 60 days after MI. Primary end point was all-cause mortality at 3 years follow-up. The trial prematurely ended after inclusion of 266 patients (38% of the calculated sample size). Additional survival assessment was performed in February 2019 for the primary end point.
RESULTS
A total of 266 patients, 78.2% males, with a mean age of 60.8±11.3 years, were enrolled. One hundred thirty-one patients were randomized to the ICD arm and 135 patients to the control arm. All-cause mortality was significant lower in the ICD group (5% versus 13%, hazard ratio, 0.37 [95% CI, 0.15-0.95]) after 3 years follow-up. Appropriate ICD therapy occurred in 9 patients at 3 years follow-up (5 within the first 8 months after implantation). After a median long-term follow-up of 9 years (interquartile range, 3-11), total mortality (18% versus 38%; hazard ratio, 0.58 [95% CI, 0.37-0.91]), and cardiac mortality (hazard ratio, 0.52 [95% CI, 0.28-0.99]) was significant lower in the ICD group. Noncardiac death was not significantly different between groups. Left ventricular ejection fraction increased ≥10% in 46.5% of the patients during follow-up, and the extent of improvement was similar in both study groups.
CONCLUSIONS
In this prematurely terminated and thus underpowered randomized trial, early prophylactic ICD implantation demonstrated lower total and cardiac mortality in patients with high-risk ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention. Registration: URL: https://www.trialregister.nl; Unique identifier: Trial NL74 (NTR105).",2020,"All-cause mortality was significant lower in the ICD group (5% vs 13%, HR 0.37; 95% CI 0.15-0.95) after 3 years follow-up.","['high risk primary PCI patients, based on one of the following factors: left ventricular ejection fraction (LVEF) < 30% within 4 days after STEMI, primary ventricular fibrillation, Killip class ≥2 and/or TIMI flow < 3 after PCI', '266 patients (38% of the calculated sample size', 'early selected high-risk patients after primary percutaneous coronary intervention (PCI) for ST elevation myocardial infarction (STEMI', ' A total of 266 patients, 78.2% males, with a mean age of 60.8 ± 11.3 years, were enrolled', '131 patients were randomized to the ICD arm and 135 patients to the control arm']","['Randomized Defibrillator', 'ICD', 'prophylactic ICD implantation', 'conventional medical therapy', 'prophylactic implantable cardioverter defibrillator (ICD) implantation', 'Defibrillator']","['cardiac mortality', 'survival benefit', 'ICD', 'cause mortality', 'LVEF', 'cardiac death', 'total mortality', 'All-cause mortality', 'total and cardiac mortality', 'Additional survival assessment']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",131.0,0.182527,"All-cause mortality was significant lower in the ICD group (5% vs 13%, HR 0.37; 95% CI 0.15-0.95) after 3 years follow-up.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Haanschoten', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Anand R', 'Initials': 'AR', 'LastName': 'Ramdat Misier', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Peter Paul H M', 'Initials': 'PPHM', 'LastName': 'Delnoy', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Jaap Jan J', 'Initials': 'JJJ', 'LastName': 'Smit', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Adiyaman', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Demirel', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': 'Hein J J', 'Initials': 'HJJ', 'LastName': 'Wellens', 'Affiliation': 'Cardiovascular Research Centre Maastricht, the Netherlands (H.J.J.W.).'}, {'ForeName': 'Freek W A', 'Initials': 'FWA', 'LastName': 'Verheugt', 'Affiliation': 'Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands (F.W.A.V.).'}, {'ForeName': 'Jan Paul', 'Initials': 'JP', 'LastName': 'Ottervanger', 'Affiliation': 'Department of Cardiology, Isala Heart Center, Zwolle, the Netherlands (D.M.H., A.E., A.R.R.M., P.P.H.M.D., J.J.J.S., A.A., F.D., J.P.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.120.008484']
2114,32990938,Extended-Release Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl for Postoperative Moderate-to-Severe Pain: A Randomized Controlled Trial.,"INTRODUCTION
Post-operative pain control remains unsatisfactory in patients after laparotomy. This study aimed to evaluate the efficacy, safety, and quality of life with a single dose of extended-release dinalbuphine sebacate (ERDS) pre-operatively to intravenous patient-controlled analgesia (PCA) with fentanyl in patients undergoing laparotomy.
METHODS
This was a prospective, open-label, randomized controlled study. Of 110 randomized patients, 107 completed all assessments. The area under the curve (AUC) of visual analogue scale (VAS) from baseline to 48 h after surgery, VAS throughout 7 days after surgery, post-operative analgesics use, quality of life, satisfaction, and safety were evaluated.
RESULTS
The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6-141.6] in ERDS group and 176.13 (97.5% CI 150.8-201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001). ERDS group reported a significant reduction in VAS pain intensity at 4, 24, 32, 72, 120, and 144 h after surgery, and better quality of life (P < 0.05). The safety profile was comparable between ERDS and PCA groups.
CONCLUSIONS
In patients undergoing laparotomy, a single dose of dinalbuphine sebacate was superior to intravenous PCA with fentanyl on lower pain intensity and better quality of life.
TRIAL REGISTRATION
NCT03296488.",2020,"RESULTS
The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6-141.6] in ERDS group and 176.13 (97.5% CI 150.8-201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001).","['Postoperative Moderate-to-Severe Pain', 'patients after laparotomy', 'Of 110 randomized patients, 107 completed all assessments', 'patients undergoing laparotomy']","['ERDS', 'extended-release dinalbuphine sebacate (ERDS) pre-operatively to intravenous patient-controlled analgesia (PCA) with fentanyl', 'Dinalbuphine Sebacate Versus Intravenous Patient-Controlled Analgesia with Fentanyl', 'PCA with fentanyl', 'dinalbuphine sebacate']","['safety profile', 'area under the curve (AUC) of visual analogue scale (VAS', 'efficacy, safety, and quality of life', 'AUC of VAS', 'pain intensity and better quality of life', 'quality of life', 'quality of life, satisfaction, and safety', 'VAS pain intensity']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0946377', 'cui_str': 'sebacate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",110.0,0.166089,"RESULTS
The AUC of VAS from baseline to 48 h after surgery were 118.6 [97.5% confidence interval (CI) 95.6-141.6] in ERDS group and 176.13 (97.5% CI 150.8-201.4) in PCA group, which showed the non-inferiority because the upper limit of the 97.5% CIs of ERDS group was lower than the lower limit of PCA group (P < 0.001), but also had superiority in favor of ERDS group (P < 0.001).","[{'ForeName': 'Tsung-Kun', 'Initials': 'TK', 'LastName': 'Chang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-Jen', 'Initials': 'CJ', 'LastName': 'Ma', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yung-Sung', 'Initials': 'YS', 'LastName': 'Yeh', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Yen-Cheng', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Ching-Chun', 'Initials': 'CC', 'LastName': 'Li', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Kuang-I', 'Initials': 'KI', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Miao-Pei', 'Initials': 'MP', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. cy614112@ms14.hinet.net.'}]",Pain and therapy,['10.1007/s40122-020-00197-x']
2115,32990963,Using a Complementary Intervention to Decrease Postoperative Nausea and Vomiting.,,2020,,[],[],['Postoperative Nausea and Vomiting'],[],[],"[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",,0.0458791,,"[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Spruce', 'Affiliation': ''}]",AORN journal,['10.1002/aorn.13193']
2116,32988969,A Randomized Placebo Controlled Phase II Trial Evaluating Exemestane with or without Enzalutamide in Patients with Hormone Receptor-Positive Breast Cancer.,"PURPOSE
To determine whether the androgen receptor (AR) inhibitor, enzalutamide, improves effectiveness of endocrine therapy (ET) in hormone receptor-positive (HR + ) breast cancer.
PATIENTS AND METHODS
In this phase II trial, patients with HR + /HER2 normal advanced/metastatic breast cancer were randomized 1:1 to exemestane 25 mg with placebo or exemestane 50 mg with enzalutamide 160 mg daily (NCT02007512). Two parallel cohorts enrolled patients with 0 (cohort 1) or 1 (cohort 2) prior ET for advanced disease. Progression-free survival (PFS) was the primary endpoint in the intent-to-treat (ITT) population of each cohort. Biomarkers were evaluated in an exploratory analysis.
RESULTS
Overall, 247 patients were randomized (cohort 1, n = 127 and cohort 2, n = 120). PFS was not improved in either cohort of the ITT population [HR, 0.82 (95% confidence interval (CI), 0.54-1.26); P = 0.3631 for cohort 1 and HR, 1.02 (95% CI, 0.66-1.59); P = 0.9212 for cohort 2]. In cohort 1, high levels of AR mRNA were associated with greater benefit of enzalutamide ( P interaction = 0.0048). This effect was particularly apparent in patients with both high levels of AR mRNA and low levels of ESR1 mRNA [HR, 0.24 (95% CI, 0.10-0.60); P = 0.0011]. The most common any grade adverse events in the enzalutamide arms were nausea (39%) in cohort 1 and fatigue (37%) in cohort 2.
CONCLUSIONS
Enzalutamide with exemestane was well tolerated. While PFS was not improved by the addition of enzalutamide to exemestane in an unselected population, ET-naïve patients with high AR mRNA levels, particularly in combination with low ESR1 mRNA levels, may benefit from enzalutamide with exemestane.",2020,PFS was not improved in either cohort of the ITT population (hazard ratio [HR] 0.82 [95% CI 0.54-1.26]; P =0.3631 for cohort 1; HR 1.02,"['247 patients were randomized (cohort 1, n=127; cohort 2, n=120', 'patients with HR+/HER2-normal advanced/metastatic breast cancer', 'Patients With Hormone Receptor-positive Breast Cancer', 'Two parallel cohorts enrolled patients with 0 (cohor 1) or 1 (cohort 2) prior ET for advanced disease', 'patients with both high AR mRNA and low levels of ESR1 mRNA (HR 0.24']","['exemestane 25 mg with placebo or exemestane 50 mg with enzalutamide', 'Exemestane With or Without Enzalutamide', 'enzalutamide', 'androgen receptor (AR) inhibitor enzalutamide', 'exemestane', 'Enzalutamide with exemestane', 'Placebo', 'endrocrine therapy (ET']","['grade adverse events', 'Progression-free survival (PFS', 'nausea', 'tolerated', 'PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C4517441', 'cui_str': '0.24'}]","[{'cui': 'C1125968', 'cui_str': 'exemestane 25 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0034786', 'cui_str': 'Androgen receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",247.0,0.247884,PFS was not improved in either cohort of the ITT population (hazard ratio [HR] 0.82 [95% CI 0.54-1.26]; P =0.3631 for cohort 1; HR 1.02,"[{'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts. ikrop@partners.org.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO, European Institute of Oncology, IRCCS, Milan, Italy.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Traina', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Frankie', 'Initials': 'F', 'LastName': 'Holmes', 'Affiliation': 'Texas Oncology-Houston Memorial City, US Oncology Network, The Woodlands, Texas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Garcia-Estevez', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Lowell', 'Initials': 'L', 'LastName': 'Hart', 'Affiliation': 'Florida Cancer Specialists, Fort Myers, Florida.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Awada', 'Affiliation': 'Department of Oncology Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Zamagni', 'Affiliation': 'Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Bologna, Italy.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': 'Morris', 'Affiliation': 'Beaumont Hospital and Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'University of Tennessee, West Cancer Center, Memphis, Tennessee.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Nottingham University Hospital, City Campus, Nottingham, England, United Kingdom.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Gucalp', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Biganzoli', 'Affiliation': 'Nuovo Ospedale di Prato, Tuscany, Italy.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Steinberg', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, Illinois.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Sica', 'Affiliation': 'Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Trudeau', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Denka', 'Initials': 'D', 'LastName': 'Markova', 'Affiliation': 'Formerly of Pfizer Inc., San Francisco, California.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Tarazi', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Pfizer Inc., La Jolla, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'Pfizer Inc., San Francisco, California.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Kelly', 'Affiliation': 'Mater Misericordiae University Hospital, Dublin and Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': 'Sarah Cannon Research Institute, Tennessee Oncology, PLLC, Nashville, Tennessee.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1693']
2117,32992075,Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo in critically-ill patients with COVID-19: Rationale and design of the INSPIRATION/INSPIRATION-S studies.,"BACKGROUND
Microvascular and macrovascular thrombotic events are among the hallmarks of coronavirus disease 2019 (COVID-19). Furthermore, the exuberant immune response is considered an important driver of pulmonary and extrapulmonary manifestations of COVID-19. The optimal management strategy to prevent thrombosis in critically-ill patients with COVID-19 remains unknown.
METHODS
The Intermediate versus Standard-dose Prophylactic anticoagulation In cRitically-ill pATIents with COVID-19: An opeN label randomized controlled trial (INSPIRATION) and INSPIRATION-statin (INSPIRATION-S) studies test two independent hypotheses within a randomized controlled trial with 2 × 2 factorial design. Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation. The 600 patients undergoing this randomization will be screened and if meeting the eligibility criteria, will undergo an additional double-blind stratified randomization to atorvastatin 20 mg daily versus matching placebo. The primary endpoint, for both hypotheses will be tested for superiority and includes a composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death within 30 days from enrollment. Key secondary endpoints include all-cause mortality, adjudicated VTE, and ventilator-free days. Key safety endpoints include major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL) for the anticoagulation hypothesis. In a prespecified secondary analysis for non-inferiority, the study will test for the non-inferiority of intermediate intensity versus standard dose anticoagulation for major bleeding, considering a non-inferiority margin of 1.8 based on odds ratio. Key safety endpoints for the statin hypothesis include rise in liver enzymes >3 times upper normal limit and clinically-diagnosed myopathy. The primary analyses will be performed in the modified intention-to-treat population. Results will be tested in exploratory analyses across key subgroups and in the intention-to-treat and per-protocol cohorts.
CONCLUSIONS
INSPIRATION and INSPIRATON-S studies will help address clinically-relevant questions for antithrombotic therapy and thromboinflammatory therapy in critically-ill patients with COVID-19.",2020,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"['critically-ill patients with COVID-19 remains unknown', '600 patients undergoing this randomization will be screened and if meeting the eligibility criteria', 'cRitically-ill pATIents with COVID-19', 'critically-ill patients with COVID-19', 'Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19']","['Intermediate versus standard-dose prophylactic anticoagulation and statin therapy versus placebo', 'Prophylactic anticoagulation', 'atorvastatin 20\xa0mg daily versus matching placebo']","['major bleeding according to the Bleeding Academic Research Consortium definition and severe thrombocytopenia (platelet count <20,000/fL', 'composite of adjudicated acute arterial thrombosis, venous thromboembolism (VTE), use of extracorporeal membrane oxygenation, or all-cause death', 'cause mortality, adjudicated VTE, and ventilator-free days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1379773', 'cui_str': 'atorvastatin 20 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",600.0,0.474016,Hospitalized critically-ill patients with reverse transcription polymerase chain reaction confirmed COVID-19 will be randomized to intermediate-dose versus standard dose prophylactic anticoagulation.,"[{'ForeName': 'Behnood', 'Initials': 'B', 'LastName': 'Bikdeli', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA; Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Cardiovascular Research Foundation (CRF), New York, NY, USA. Electronic address: bbikdeli@bwh.harvard.edu.""}, {'ForeName': 'Azita H', 'Initials': 'AH', 'LastName': 'Talasaz', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Rashidi', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif-Kashani', 'Affiliation': 'Tobacoo Prevention and control Research center, National Research lnstitute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran; Lung Transplantion Research Center, Department of Cardiology, National Research Institute of Tuberculosls and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Farrokhpour', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Bakhshandeh', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Hashem', 'Initials': 'H', 'LastName': 'Sezavar', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Dabbagh', 'Affiliation': 'Department of Anesthesiology, School of Medicine Anesthesiology Research Center Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Beigmohammadi', 'Affiliation': 'Anesthesiology and Intensive Care, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Payandemehr', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yadollahzadeh', 'Affiliation': 'Firouzgar Hospital, Department of Internal Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Taghi', 'Initials': 'T', 'LastName': 'Riahi', 'Affiliation': 'Rasoul-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Jamalkhani', 'Affiliation': 'Student Research Committee, Iran University of Medical Sciences, Tehran, Iran; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rezaeifar', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Lookzadeh', 'Affiliation': 'Chronic Respiratory Disease Research Center, Masih Daneshvari Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Shahmirzaei', 'Affiliation': 'Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ouria', 'Initials': 'O', 'LastName': 'Tahamtan', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Matin', 'Affiliation': 'Tuberclosis and Lung Diseases Research Center, Tabriz, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Ehsan', 'Initials': 'SE', 'LastName': 'Parhizgar', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jimenez', 'Affiliation': 'Respiratory Department, Hospital Ramón y Cajal (IRYCIS), Madrid, Spain; Medicine Department, Universidad de Alcalá (IRYCIS), Madrid, Spain; CIBER Enfermedades Respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Aakriti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Sahil A', 'Initials': 'SA', 'LastName': 'Parikh', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Monreal', 'Affiliation': 'Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Universidad Católica de Murcia, Murcia, Spain.'}, {'ForeName': 'Naser', 'Initials': 'N', 'LastName': 'Hadavand', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Hajighasemi', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Maleki', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Sadeghian', 'Affiliation': 'Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Rajaie Cardiovascular Medical and Research Center, Iran university of Medical sciences, Tehran, Iran.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Piazza', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'Cardiovascular Research Foundation (CRF), New York, NY, USA; Division of Cardiology, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Harlan M', 'Initials': 'HM', 'LastName': 'Krumholz', 'Affiliation': 'Yale/YNHH Center for Outcomes Research & Evaluation, New Haven, CT, USA; Section of Cardiovascular Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; Department of Health Policy and Adminitration, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Samuel Z', 'Initials': 'SZ', 'LastName': 'Goldhaber', 'Affiliation': ""Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran; Clinical Trial Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Iran. Electronic address: psadeghipour@hotmail.com.'}]",Thrombosis research,['10.1016/j.thromres.2020.09.027']
2118,32992151,Cost and cost-effectiveness of interim methadone treatment and patient navigation initiated in jail.,"BACKGROUND
Individuals with opioid use disorder (OUD) who are released from pre-trial detention in jail have a high risk of opioid relapse. While several interventions for OUD initiated during incarceration have been studied, few have had an economic evaluation. As part of a three-group randomized trial, we estimated the cost and cost-effectiveness of a negative urine opioid test. Detainees were assigned to interim methadone (IM) in jail with continued methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group.
METHODS
We implemented a micro-costing approach from the provider's perspective to estimate the cost per participant in jail and over the 12 months post-release from jail. Economic data included jail-based and community-based service utilization, self-reported healthcare utilization and justice system involvement, and administrative arrest records. Our outcome measure is the number of participants with a negative opioid urine test at their 12-month follow-up. We calculated incremental cost-effectiveness ratios (ICERs) for intervention costs only and costs from a societal perspective.
RESULTS
The average cost of providing patient navigation services per individual beginning in jail and continuing in the community was $283. We find that IM is dominated by ETAU and IM + PN. Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
CONCLUSIONS
IM + PN is almost certainly the cost-effective choice from both an intervention provider and societal perspective.",2020,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","['patient navigation initiated in jail', 'Individuals with opioid use disorder (OUD']","['interim methadone', 'methadone treatment post-release with and without 3 months of post-release patient navigation (PN) compared to an enhanced treatment-as-usual group', 'negative urine opioid test']","['incremental cost-effectiveness ratios (ICERs', 'average cost of providing patient navigation services', 'cost and cost-effectiveness', 'Cost and cost-effectiveness']","[{'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",,0.0840355,"Per additional participant with a negative opioid urine test, the ICER for IM + PN including intervention costs only is $91 and $305 including societal costs.
","[{'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Zarkin', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Orme', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States. Electronic address: sorme@rti.org.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Dunlap', 'Affiliation': 'RTI, International, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, United States.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Kelly', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Shannon G', 'Initials': 'SG', 'LastName': 'Mitchell', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': ""O'Grady"", 'Affiliation': 'Department of Psychology, University of Maryland, College Park, 4094 Campus Drive, College Park, MD 20742, United States.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Schwartz', 'Affiliation': 'Friends Research Institute, 1040 Park Avenue Suite 103. Baltimore, MD 21201, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108292']
2119,32996010,"Consequences of Supraphysiological Dialysate Magnesium on Arterial Stiffness, Hemodynamic Profile, and Endothelial Function in Hemodialysis: A Randomized Crossover Study Followed by a Non-Controlled Follow-Up Phase.","INTRODUCTION
Increasing dialysate magnesium (D-Mg 2+ ) appears to be an intriguing strategy to obtain cardiovascular benefits in subjects with end-stage kidney disease (ESKD) on hemodialysis. To date, however, hemodialysis guidelines do not suggest to increase D-Mg 2+ routinely set at 0.50 mmol/L.
METHODS
A randomized 4-week crossover study aimed at investigating the consequences of increasing D-Mg 2+ from 0.50 to 0.75 mmol/L on arterial stiffness, hemodynamic profile, and endothelial function in subjects undergoing hemodialysis. The long-term effect of higher D-Mg 2+ on mineral metabolism markers was investigated in a 6-month follow-up. Data were analyzed by linear mixed models for repeated measures.
RESULTS
Data of 39 patients were analyzed. Pulse wave velocity and pulse pressure significantly decreased on the higher D-Mg 2+ compared with the standard one by - 0.91 m/s (95% confidence interval - 1.52 to - 0.29; p = 0.01) and - 9.61 mmHg (- 18.89 to - 0.33, p = 0.04), respectively. A significant reduction in systolic blood pressure of - 12.96 mmHg (- 24.71 to - 1.22, p = 0.03) was also observed. No period or carryover effects were observed. During the long-term follow-up phase the higher D-Mg 2+ significantly increased ionized and total serum Mg (respectively from 0.54 to 0.64 and from 0.84 to 1.07 mmol/L; mean percentage change from baseline to follow-up + 21% and + 27%; p ≤ 0.001), while parathormone (PTH) decreased significantly (from 36.6 to 34.4 pmol/L; % change - 11%, p = 0.03).
CONCLUSIONS
Increasing dialysate magnesium improves vascular stiffness in subjects undergoing maintenance hemodialysis. The present findings merit a larger trial to evaluate the effects of 0.75 mmol/L D-Mg 2+ on major clinical outcomes.
TRIAL REGISTRATION
The study was retrospectively registered on the ISRCTN registry (ISRCTN 74139255) on 18 June 2020.",2020,"A significant reduction in systolic blood pressure of - 12.96 mmHg (- 24.71 to - 1.22, p = 0.03) was also observed.","['Hemodialysis', 'subjects with end-stage kidney disease (ESKD) on hemodialysis', '39 patients were analyzed', 'subjects undergoing hemodialysis', 'subjects undergoing maintenance hemodialysis']","['dialysate magnesium', 'Supraphysiological Dialysate Magnesium', 'increasing D-Mg 2+ from 0.50 to 0.75\xa0mmol/L']","['carryover effects', 'mineral metabolism markers', 'parathormone (PTH', 'arterial stiffness, hemodynamic profile, and endothelial function', 'ionized and total serum Mg', 'Pulse wave velocity and pulse pressure', 'systolic blood pressure', 'vascular stiffness', 'Arterial Stiffness, Hemodynamic Profile, and Endothelial Function']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]","[{'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}]",39.0,0.0276237,"A significant reduction in systolic blood pressure of - 12.96 mmHg (- 24.71 to - 1.22, p = 0.03) was also observed.","[{'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'Del Giorno', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland. rosaria.delgiorno@eoc.ch.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Lavorato Hadjeres', 'Affiliation': 'Nephrology and Dialysis Service, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Kevyn', 'Initials': 'K', 'LastName': 'Stefanelli', 'Affiliation': 'Department of Social Sciences and Economics, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Allegra', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Zapparoli', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Lazarevic', 'Initials': 'L', 'LastName': 'Predrag', 'Affiliation': 'Nephrology and Dialysis Service, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Berwert', 'Affiliation': 'Nephrology and Dialysis Service, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Gabutti', 'Affiliation': 'Department of Internal Medicine, Clinical Research Unit, Regional Hospital of Bellinzona and Valli, Ente Ospedaliero Cantonale, Bellinzona, Switzerland. luca.gabutti@eoc.ch.'}]",Advances in therapy,['10.1007/s12325-020-01505-9']
2120,32996444,Gut Bacterial Diversity and Growth among Preschool Children in Burkina Faso.,"There is a lack of empirical, prospective human data on the gut microbiome and its relationship with growth, especially in low- and middle-income countries. We prospectively assessed the association between gut microbial diversity and short-term growth in a cohort of preschool children in Burkina Faso to better characterize whether there is any evidence that changes in gut microbial diversity may affect growth. Data were obtained from a randomized controlled trial evaluating the effect of antibiotic administration on gut microbial diversity in preschool children. We followed up the enrolled children for 35 days, with anthropometric measurements at baseline and day 35 and microbial diversity measured at baseline and day 9 (analytic sample, N = 155). We estimated linear mixed-effects regression models with household random intercepts to assess the association of Simpson's and Shannon's alpha diversity with measures of change in anthropometry (e.g., ponderal growth since baseline) and absolute anthropometric measurements (e.g., day 35 weight). We did not find evidence that alpha gut microbial diversity was associated with growth or absolute anthropometric measurements after adjusting for confounding variables. Effect estimates were close to the null ( P ≥ 0.15 for all fully adjusted comparisons), with the association between Simpson's alpha diversity and day 35 height (cm) farthest from the null (coefficient = -0.03, 95% CI: -0.07, 0.01). The change in gut microbial diversity also was not associated with the change in anthropometry in crude or adjusted models. Future research is needed to explore whether gut diversity has an impact on growth over a longer time period, in both healthy and malnourished children.",2020,We did not find evidence that alpha gut microbial diversity was associated with growth or absolute anthropometric measurements after adjusting for confounding variables.,"['healthy and malnourished children', 'preschool children', 'Preschool Children in Burkina Faso']",['antibiotic administration'],['gut microbial diversity'],"[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]","[{'cui': 'C0199779', 'cui_str': 'Administration of antibiotic'}]","[{'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}]",,0.0609947,We did not find evidence that alpha gut microbial diversity was associated with growth or absolute anthropometric measurements after adjusting for confounding variables.,"[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Digitale', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sié', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Boubacar', 'Initials': 'B', 'LastName': 'Coulibaly', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Lucienne', 'Initials': 'L', 'LastName': 'Ouermi', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Dah', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Charlemagne', 'Initials': 'C', 'LastName': 'Tapsoba', 'Affiliation': 'Centre de Recherche en Santé de Nouna, Nouna, Burkina Faso.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Medellena Maria', 'Initials': 'MM', 'LastName': 'Glymour', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Department of Ophthalmology, Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Department of Ophthalmology, Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, Francis I Proctor Foundation, University of California, San Francisco, San Francisco, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0059']
2121,33232866,Barefoot walking changed relative timing during the support phase but not ground reaction forces in children when compared to different footwear conditions.,"BACKGROUND
There is a paucity of available biomechanical kinetic data comparing shod and barefoot conditions in children.
RESEARCH QUESTION
Do children wearing footwear have comparable gait velocity, ground reaction forces (GRF), spatiotemporal parameters, propulsive and braking impulses when compared to children walking barefoot?
METHODS
Seventy-five children were divided into four groups: Group 1 females aged 4-9 years old (n = 29). Group 2 females aged 3-5 years old (n = 16). Group 3 males aged 6-9 years old (n = 13). Group 4 males aged 4-8 years old (n = 17). Children walked at a self-selected pace over a walkway of force platforms. Each footwear and barefoot represented a separate condition. The order of conditions was randomized. A repeated-measures ANOVA was performed to investigate the effects of the footwear type on gait parameters in each group. Multiple comparisons with Bonferroni corrections were conducted when appropriate.
RESULTS
There were no statistical differences in velocity or in vertical and anteroposterior GRF across conditions for all groups. There was a significant effect of the footwear worn on time to loading response peak (p = 0.008), time to midstance force (p = 0.006), and time to propulsive peak (p < 0.001). For Group 3, there was a significant effect of the footwear worn on time to braking peak (p < 0.001) and time to propulsive peak (p < 0.001). Regarding impulses for Group 1, there was a significant effect of the footwear worn on the loading response impulse (p = 0.016) and terminal stance and pre-swing impulse (p = 0.001). For Group 4, there was a significant effect of the footwear worn on the loading response impulse (p = 0.028).
SIGNIFICANCE
There is no influence of the evaluated children's footwear on gait velocity or GRF.",2020,"Regarding impulses for Group 1, there was a significant effect of the footwear worn on the loading response impulse (p = 0.016) and terminal stance and pre-swing impulse (p = 0.001).","['Group 4 males aged 4-8 years old (n = 17', 'children', 'Group 3 males aged 6-9 years old (n = 13', 'Seventy-five children were divided into four groups: Group 1 females aged 4-9 years old (n = 29', 'Group 2 females aged 3-5 years old (n = 16']",['Barefoot walking'],"['time to propulsive peak', 'loading response impulse', 'gait velocity or GRF', 'gait velocity, ground reaction forces (GRF), spatiotemporal parameters, propulsive and braking impulses', 'time to braking peak', 'time to midstance force', 'terminal stance and pre-swing impulse', 'time to loading response peak']","[{'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0442758', 'cui_str': '3/5'}]","[{'cui': 'C0277844', 'cui_str': 'Barefoot walking'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3653283', 'cui_str': 'PROPULSIVES'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",75.0,0.0282726,"Regarding impulses for Group 1, there was a significant effect of the footwear worn on the loading response impulse (p = 0.016) and terminal stance and pre-swing impulse (p = 0.001).","[{'ForeName': 'Gustavo Sandri', 'Initials': 'GS', 'LastName': 'Heidner', 'Affiliation': 'East Carolina University, Greenville, NC 27858, USA.'}, {'ForeName': 'Rodrigo Berneiras', 'Initials': 'RB', 'LastName': 'Nascimento', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, RS 90619-900, Brazil. Electronic address: sandriheidnerg17@students.ecu.edu.'}, {'ForeName': 'Andreia Gomes', 'Initials': 'AG', 'LastName': 'Aires', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, RS 90619-900, Brazil. Electronic address: rodrigobernasc@gmail.com.'}, {'ForeName': 'Rafael Reimann', 'Initials': 'RR', 'LastName': 'Baptista', 'Affiliation': 'Pontifical Catholic University of Rio Grande do Sul, Porto Alegre, RS 90619-900, Brazil. Electronic address: rafael.baptista@pucrs.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.10.034']
2122,33232912,Effect of one year krill oil supplementation on depressive symptoms and self-esteem of Dutch adolescents: A randomized controlled trial.,"INTRODUCTION
Observational studies have shown a relationship between omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) and depression in adolescents. However, n-3 LCPUFA supplementation studies investigating the potential improvement in depressive feelings in adolescents from the general population are missing.
METHODS
A one-year double-blind, randomized, placebo controlled krill oil supplementation trial was conducted in two cohorts. Cohort I started with 400 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or placebo, after three months this increased to 800 mg EPA and DHA per day, whilst cohort II started with this higher dose. Omega-3 Index (O3I) was monitored via finger-prick blood measurements. At baseline, six and 12 months participants completed the Centre for Epidemiologic Studies Depression Scale (CES-D) and the Rosenberg Self Esteem questionnaire (RSE). Adjusted mixed models were run with treatment allocation/O3I as predictor of CES-D and RSE scores.
RESULTS
Both intention-to-treat and assessing the change in O3I analyses did not show significant effects on CES-D or RSE scores.
CONCLUSION
There is no evidence for less depressive feelings, or higher self-esteem after one year of krill oil supplementation. However, due to a lack of adherence and drop-out issues, these results should be interpreted with caution.",2020,"There is no evidence for less depressive feelings, or higher self-esteem after one year of krill oil supplementation.","['Dutch adolescents', 'adolescents']","['krill oil supplementation', 'omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA', 'n-3 LCPUFA supplementation', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or placebo', 'placebo controlled krill oil supplementation']","['depressive symptoms and self-esteem', 'Centre for Epidemiologic Studies Depression Scale (CES-D) and the Rosenberg Self Esteem questionnaire (RSE', 'depressive feelings', 'CES-D or RSE scores', 'Omega-3 Index (O3I']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C2725341', 'cui_str': 'krill oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582666', 'cui_str': 'Rosenberg self-esteem scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.608229,"There is no evidence for less depressive feelings, or higher self-esteem after one year of krill oil supplementation.","[{'ForeName': 'I S M', 'Initials': 'ISM', 'LastName': 'van der Wurff', 'Affiliation': 'Faculty of Educational Sciences, Open University of the Netherlands, the Netherlands, Heerlen 6419 AT, the Netherlands. Electronic address: inge.vanderwurff@ou.nl.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'von Schacky', 'Affiliation': 'Omegametrix, Martinsried 82 152, Germany; Preventive Cardiology, Medical Clinic and Poli-Clinic I, Ludwig Maximilians-University Munich, 80336 Munich, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bergeland', 'Affiliation': 'Aker BioMarine Antarctic AS, Lysaker NO-1327, Norway (former).'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Leontjevas', 'Affiliation': 'Faculty of Psychology, Open University of the Netherlands, 6419 AT Heerlen, The Netherlands.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Zeegers', 'Affiliation': 'Nutrition and Translational Research in Metabolism (School NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands; Care and Public Health Research Institute (School CAPHRI), Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Kirschner', 'Affiliation': 'Faculty of Educational Sciences, Open University of the Netherlands, the Netherlands, Heerlen 6419 AT, the Netherlands; Expertise Centre for Effective Learning, Thomas More University of Applied Sciences, Mechelen, Belgium; University of Oulu, Oulu, Finland.'}, {'ForeName': 'R H M', 'Initials': 'RHM', 'LastName': 'de Groot', 'Affiliation': 'Faculty of Educational Sciences, Open University of the Netherlands, the Netherlands, Heerlen 6419 AT, the Netherlands; Nutrition and Translational Research in Metabolism (School NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102208']
2123,33001439,A prospective comparison of four methods for preventing pacemaker pocket infections.,"This study aims to evaluate four pacemaker pocket cleaning methods for preventing implantation-related infections. This single-center trial prospectively randomized 910 patients undergoing first-time pacemaker implantation or replacement into four pocket cleaning methods: hemocoagulase (group A, n = 228), gentamicin (group B, n = 228), hemocoagulase plus gentamicin (group C, n = 227), and normal saline (group D, n = 227). Before implanting the pacemaker battery, the pockets were cleaned with gauze presoaked in the respective cleaning solutions. Then, these patients were followed up to monitor the occurrence of infections for 1 month after implantation. Twelve implantation-related infections occurred in 910 patients (1.32%): four patients from group A (1.75%), three patients from group B (1.32%), two patients from group C (0.88%), and three patients from group D (1.32%) (P > .05). Furthermore, two patients developed bloodstream infections (0.22%), and both of these patients were associated with pocket infection (one patient was from group A, while the other patient was from group C, respectively). No cases of infective endocarditis occurred. The differences in the number of infections in these study groups were not statistically significant. The application of hemocoagulase, gentamicin, hemocoagulase plus gentamicin, or normal saline on the presoaked gauze before implantation was equally effective in preventing pocket-associated infections.",2020,"RESULTS
Twelve implantation-related infections occurred in 910 patients (1.32%): four patients from group A (1.75%), three patients from group B (1.32%), two patients from group C (0.88%), and three patients from group D (1.32%) (P>0.05).","['910 patients undergoing first-time pacemaker implantation or replacement into four pocket cleaning methods: hemocoagulase (group A, n=228']","['gentamicin, hemocoagulase plus gentamicin, or normal saline', 'hemocoagulase plus gentamicin', 'gentamicin', 'normal saline']","['bloodstream infections', 'infections', 'infective endocarditis', 'pocket infection', 'number of infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0917789', 'cui_str': 'Hemocoagulase'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0917789', 'cui_str': 'Hemocoagulase'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0014121', 'cui_str': 'Bacterial endocarditis'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",910.0,0.0533211,"RESULTS
Twelve implantation-related infections occurred in 910 patients (1.32%): four patients from group A (1.75%), three patients from group B (1.32%), two patients from group C (0.88%), and three patients from group D (1.32%) (P>0.05).","[{'ForeName': 'Yao-Dong', 'Initials': 'YD', 'LastName': 'Li', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'MaiMaiTiMin', 'Initials': 'M', 'LastName': 'MaiMaiTiABuDuLa', 'Affiliation': 'Cardiology Department, the 5th Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Gui-Qiu', 'Initials': 'GQ', 'LastName': 'Cao', 'Affiliation': 'Cardiology Department, the 5th Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'MaiMaiTiMin', 'Initials': 'M', 'LastName': 'MaiMaiTiAiLi', 'Affiliation': ""Emergency Department, West Branch Hospital of Hetian District People's Hospital, HeTian, China.""}, {'ForeName': 'Xian-Hui', 'Initials': 'XH', 'LastName': 'Zhou', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Yan-Mei', 'Initials': 'YM', 'LastName': 'Lu', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Jiang-Hua', 'Initials': 'JH', 'LastName': 'Zhang', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Xing', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Chuang-Ju', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Ge-Ge', 'Initials': 'GG', 'LastName': 'Zhang', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}, {'ForeName': 'Bao-Peng', 'Initials': 'BP', 'LastName': 'Tang', 'Affiliation': 'Pacing and Electrophysiology Department, First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.'}]",Artificial organs,['10.1111/aor.13832']
2124,33233328,Slackline Training in Children with Spastic Cerebral Palsy: A Randomized Clinical Trial.,"OBJECTIVE
To assess whether a slackline intervention program improves postural control in children/adolescents with spastic cerebral palsy (CP).
DESIGN
Randomized controlled trial.
SETTING
Patients' association.
PARTICIPANTS
Twenty-seven children/adolescents with spastic CP (9-16 years) were randomly assigned to a slackline intervention ( n = 14, 13 ± 3 years) or control group ( n = 13, 12 ± 2 years).
INTERVENTION
Three slackline sessions per week (30 min/session) for 6 weeks.
MAIN OUTCOME MEASURES
The primary outcome was static posturography (center of pressure-CoP-parameters). The secondary outcomes were surface myoelectrical activity of the lower-limb muscles during the posturography test and jump performance (countermovement jump test and Abalakov test). Overall (RPE, >6-20 scale) rating of perceived exertion was recorded at the end of each intervention session.
RESULTS
The intervention was perceived as ""very light"" (RPE = 7.6 ± 0.6). The intervention yielded significant benefits on static posturography (a significant group by time interaction on Xspeed, p = 0.006) and jump performance (a significant group by time interaction on Abalakov test, p = 0.015).
CONCLUSIONS
Slackline training improved static postural control and motor skills and was perceived as non-fatiguing in children/adolescents with spastic CP.",2020,"The intervention yielded significant benefits on static posturography (a significant group by time interaction on Xspeed, p = 0.006) and jump performance (a significant group by time interaction on Abalakov test, p = 0.015).
","['Children with Spastic Cerebral Palsy', 'children/adolescents with spastic CP', ""Patients' association"", 'Twenty-seven children/adolescents with spastic CP (9-16 years', 'children/adolescents with spastic cerebral palsy (CP']","['Slackline Training', 'Slackline training', 'slackline intervention', 'slackline intervention program']","['jump performance', 'Overall (RPE, >6-20 scale) rating of perceived exertion', 'static postural control and motor skills', 'static posturography', 'surface myoelectrical activity of the lower-limb muscles during the posturography test and jump performance (countermovement jump test and Abalakov test', 'static posturography (center of pressure-CoP-parameters', 'postural control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",27.0,0.0486424,"The intervention yielded significant benefits on static posturography (a significant group by time interaction on Xspeed, p = 0.006) and jump performance (a significant group by time interaction on Abalakov test, p = 0.015).
","[{'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'González', 'Affiliation': 'Spanish Confederation of People with Physical and Organic Disability (COCEMFE), 33204 Asturias, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Argüelles', 'Affiliation': 'Department of Functional Biology, University of Oviedo, 33006 Oviedo, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'González', 'Affiliation': 'Medical Service of the Community of Cabo Peñas, 33440 Asturias, Spain.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Winge', 'Affiliation': 'Novo Nordisk Foundation, 2900 Hellerup, Denmark.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Iscar', 'Affiliation': 'University Central Hospital of Asturias (HUCA), 33011 Asturias, Spain.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Olmedillas', 'Affiliation': 'Department of Functional Biology, University of Oviedo, 33006 Oviedo, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Blanco', 'Affiliation': 'Catholic University of Valencia, 46001 Valencia, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Department of Systems Biology, University of Alcalá, 28805 Alcalá de Henares, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': ""European University of Madrid (Faculty of Sport Sciences) and Research Institute Hospital 12 de Octubre ('i+12'), 28041 Madrid, Spain.""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Federolf', 'Affiliation': 'Department of Sport Science, University of Innsbruck, 6020 Innsbruck, Austria.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Education and Sport, University of León, 24007 León, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17228649']
2125,33233400,"Low Intensity, Transcranial, Alternating Current Stimulation Reduces Migraine Attack Burden in a Home Application Set-Up: A Double-Blinded, Randomized Feasibility Study.","Background: Low intensity, high-frequency transcranial alternating current stimulation (tACS) applied over the motor cortex decreases the amplitude of motor evoked potentials. This double-blind, placebo-controlled parallel group study aimed to test the efficacy of this method for acute management of migraines. Methods: The patients received either active (0.4 mA, 140 Hz) or sham stimulation for 15 min over the visual cortex with the number of terminated attacks two hours post-stimulation as the primary endpoint, as a home therapy option. They were advised to treat a maximum of five migraine attacks over the course of six weeks. Results: From forty patients, twenty-five completed the study, sixteen in the active and nine in the sham group with a total of 102 treated migraine attacks. The percentage of terminated migraine attacks not requiring acute rescue medication was significantly higher in the active (21.5%) than in the sham group (0%), and the perceived pain after active stimulation was significantly less for 2-4 h post-stimulation than after sham stimulation. Conclusion: tACS over the visual cortex has the potential to terminate migraine attacks. Nevertheless, the high drop-out rate due to compliance problems suggests that this method is impeded by its complexity and time-consuming setup.",2020,"The percentage of terminated migraine attacks not requiring acute rescue medication was significantly higher in the active (21.5%) than in the sham group (0%), and the perceived pain after active stimulation was significantly less for 2-4 h post-stimulation than after sham stimulation. ","['Results: From forty patients, twenty-five completed the study, sixteen in the active and nine in the sham group with a total of 102 treated migraine attacks']","[': Low intensity, high-frequency transcranial alternating current stimulation (tACS', 'placebo']","['perceived pain after active stimulation', 'percentage of terminated migraine attacks not requiring acute rescue medication']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.33528,"The percentage of terminated migraine attacks not requiring acute rescue medication was significantly higher in the active (21.5%) than in the sham group (0%), and the perceived pain after active stimulation was significantly less for 2-4 h post-stimulation than after sham stimulation. ","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Antal', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bischoff', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}, {'ForeName': 'Caspar', 'Initials': 'C', 'LastName': 'Stephani', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Czesnik', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Klinker', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Timäus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Chaieb', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Paulus', 'Affiliation': 'Department of Clinical Neurophysiology, University Medical Center, Georg-August University, 37075 Göttingen, Germany.'}]",Brain sciences,['10.3390/brainsci10110888']
2126,32987332,Lamotrigine for reducing ketamine-induced psychologic disturbances: A pilot randomized and blinded trial.,,2020,,['induced psychologic disturbances'],"['ketamine', 'Lamotrigine']",[],"[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0064636', 'cui_str': 'lamotrigine'}]",[],,0.14572,,"[{'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America. Electronic address: MAHESHK@ccf.org.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Bakal', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Xuan', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America; Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Wael Ali Sakr', 'Initials': 'WAS', 'LastName': 'Esa', 'Affiliation': 'Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'Department of Psychiatry, Cleveland Clinic, Cleveland, OH, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110074']
2127,33009190,Prevention of atelectasis by continuous positive airway pressure in anaesthetised children: A randomised controlled study.,"BACKGROUND
Continuous positive airway pressure (CPAP) prevents peri-operative atelectasis in adults, but its effect in children has not been quantified.
OBJECTIVE
The aim of this study was to evaluate the role of CPAP in preventing postinduction and postoperative atelectasis in children under general anaesthesia.
DESIGN
A randomised controlled study.
SETTING
Single-institution study, community hospital, Mar del Plata. Argentina.
PATIENTS
We studied 42 children, aged 6 months to 7 years, American Society of Anesthesiologists physical status class I, under standardised general anaesthesia.
INTERVENTIONS
Patients were randomised into two groups: Control group (n = 21): induction and emergence of anaesthesia without CPAP; and CPAP group (n = 21): 5 cmH2O of CPAP during induction and emergence of anaesthesia. Lung ultrasound (LUS) imaging was performed before and 5 min after anaesthesia induction. Children without atelectasis were ventilated in the same manner as the Control group with standard ventilatory settings including 5 cmH2O of PEEP. Children with atelectasis received a recruitment manoeuvre followed by standard ventilation with 8 cmH2O of PEEP. Then, at the end of surgery, LUS images were repeated before tracheal extubation and 60 min after awakening.
MAIN OUTCOME MEASURES
Lung aeration score and atelectasis assessed by LUS.
RESULTS
Before anaesthesia, all children were free of atelectasis. After induction, 95% in the Control group developed atelectasis compared with 52% of patients in the CPAP group (P < 0.0001). LUS aeration scores were higher (impaired aeration) in the Control group than the CPAP group (8.8 ± 3.8 vs. 3.5 ± 3.3 points; P < 0.0001). At the end of surgery, before tracheal extubation, atelectasis was observed in 100% of children in the Control and 29% of the CPAP group (P < 0.0001) with a corresponding aeration score of 9.6 ± 3.2 and 1.8 ± 2.3, respectively (P < 0.0001). After surgery, 30% of children in the Control group and 10% in the CPAP group presented with residual atelectasis (P < 0.0001) also corresponding to a higher aeration score in the Control group (2.5 ± 3.1) when compared with the CPAP group (0.5 ± 1.5; P < 0.01).
CONCLUSION
The use of 5 cmH2O of CPAP in healthy children of the studied age span during induction and emergence of anaesthesia effectively prevents atelectasis, with benefits maintained during the first postoperative hour.
TRIAL REGISTRY
Clinicaltrials.gov NCT03461770.",2021,LUS aeration scores were higher (impaired aeration) in the Control group than the CPAP group (8.8 ± 3.8 vs. 3.5 ± 3.3 points; P < 0.0001).,"['children under general anaesthesia', 'healthy children', 'Children with atelectasis received a', '42 children, aged 6 months to 7 years, American Society of Anesthesiologists physical status class', 'Single-institution study, community hospital, Mar del Plata', 'anaesthetised children']","['CPAP', 'Continuous positive airway pressure (CPAP', 'Control group (n\u200a=\u200a21): induction and emergence of anaesthesia without CPAP; and CPAP group (n\u200a=\u200a21): 5\u200acmH2O of CPAP', 'recruitment manoeuvre followed by standard ventilation with 8\u200acmH2O of PEEP', 'atelectasis by continuous positive airway pressure', 'Lung ultrasound (LUS) imaging']","['Lung aeration score and atelectasis assessed by LUS', 'residual atelectasis', 'atelectasis', 'aeration score', 'LUS aeration scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0578808', 'cui_str': 'American Society of Anesthesiologists physical status class'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0024782', 'cui_str': 'Marathi language'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}]",42.0,0.0938521,LUS aeration scores were higher (impaired aeration) in the Control group than the CPAP group (8.8 ± 3.8 vs. 3.5 ± 3.3 points; P < 0.0001).,"[{'ForeName': 'Cecilia M', 'Initials': 'CM', 'LastName': 'Acosta', 'Affiliation': 'From the Department of Anaesthesiology Hospital Privado de Comunidad (CMA, FO, GT, LV, MPLV), Department of Mathematics, Facultad de Ciencias Exactas, Universidad Nacional de Mar del Plata, Mar del Plata, Argentina (LR, MN), Hedenstierna Laboratory, Department of surgical Sciences, Uppsala University, Uppsala, Sweden (FSS), CIBERES, Instituto Carlos III (FSS) and Department of Critical Care, Hospital Universitario de La Princesa, Universidad Autonoma de Madrid, Madrid, Spain (FSS).'}, {'ForeName': 'María Paz', 'Initials': 'MP', 'LastName': 'Lopez Vargas', 'Affiliation': ''}, {'ForeName': 'Facundo', 'Initials': 'F', 'LastName': 'Oropel', 'Affiliation': ''}, {'ForeName': 'Lisandro', 'Initials': 'L', 'LastName': 'Valente', 'Affiliation': ''}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Ricci', 'Affiliation': ''}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Natal', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Suarez Sipmann', 'Affiliation': ''}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Tusman', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001351']
2128,33010323,"Tacrolimus 0.1% versus ciclopiroxolamine 1% for maintenance therapy in patients with severe facial seborrheic dermatitis: A multicenter, double-blind, randomized controlled study.","BACKGROUND
No long-term maintenance therapy has been tested in patients with seborrheic dermatitis (SD).
OBJECTIVE
We sought to compare the efficacy and tolerance of tacrolimus 0.1% ointment versus ciclopiroxolamine 1% cream as maintenance therapy for severe SD.
METHODS
This double-blind randomized controlled study was conducted from 2014 to 2017 in 5 Dermatology Departments and 15 dermatology practices in France. Consecutive patients with severe and chronic facial SD were included. Patients were initially treated with desonide 0.05% cream twice daily for 7 days. Patients cleared after this open phase were randomized to receive tacrolimus 0.1% or ciclopiroxolamine 1% cream 2 times a week 24 weeks. The primary endpoint was disease-free-duration, defined as the time from randomization to first relapse.
RESULTS
One hundred fourteen patients were randomized (tacrolimus, n = 57; ciclopiroxolamine, n = 57). Twelve patients relapsed in the tacrolimus group after a median delay of 91.5 days (range 15-195 days) versus 23 patients in the ciclopiroxolamine group (median delay, 27 days [range 13-201 days]). Comparison of disease-free duration curves showed that patients in the tacrolimus group had a longer duration of complete remission than those in the ciclopiroxolamine group (P = .018), corresponding to a hazard ratio of relapse of 0.44 (95% confidence interval 0.22-0.89; P = .022).
LIMITATIONS
The theoretical sample size was not reached.
CONCLUSION
Tacrolimus 0.1% is more effective than ciclopiroxolamine 1% as maintenance therapy for patients with facial SD.",2020,Tacrolimus 0.1% ointment applied twice a week after 7 days of topical corticosteroids is more effective than ciclopiroxolamine 1% as maintenance therapy in patients with severe facial seborrheic dermatitis.,['patients with severe facial seborrheic dermatitis'],"['Tacrolimus', 'ciclopiroxolamine']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1275433', 'cui_str': 'Facial seborrheic dermatitis'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0126169', 'cui_str': 'Ciclopirox olamine'}]",[],,0.214147,Tacrolimus 0.1% ointment applied twice a week after 7 days of topical corticosteroids is more effective than ciclopiroxolamine 1% as maintenance therapy in patients with severe facial seborrheic dermatitis.,"[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U1234, Centre de référence des maladies bulleuses autoimmunes, Normandie University, Rouen, France. Electronic address: Pascal.Joly@chu-rouen.fr.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Tejedor', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U1234, Centre de référence des maladies bulleuses autoimmunes, Normandie University, Rouen, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Tetart', 'Affiliation': 'Department of Allergology, Erik Satie Center, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Hélène Collas', 'Initials': 'HC', 'LastName': 'Cailleux', 'Affiliation': 'private practice in Le Mesnil-Esnard, France.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Barrel', 'Affiliation': 'private practice in the St-Antoine Private Clinic, Rouen, France.'}, {'ForeName': 'Paul Arnaud', 'Initials': 'PA', 'LastName': 'De Preville', 'Affiliation': 'private practice in Rouen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Mion-Mouton', 'Affiliation': 'private practice in Mont-Saint-Aignan, France.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Gabison', 'Affiliation': 'private practice in Saint-Maurice, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Baricault', 'Affiliation': 'private practice in the St-Antoine Private Clinic, Rouen, France.'}, {'ForeName': 'Catherine Girardin', 'Initials': 'CG', 'LastName': 'Tordeur', 'Affiliation': 'private practice in Bois-Guillaume, France.'}, {'ForeName': 'Martin Xavier', 'Initials': 'MX', 'LastName': 'Dore', 'Affiliation': 'private practice in Le Havre, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Rossi', 'Affiliation': 'private practice in Rouen, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bourseau-Quetier', 'Affiliation': 'private practice in Blanquefort, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Chamaillard', 'Affiliation': 'private practice in Pessac, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ly', 'Affiliation': 'private practice in Gradignan, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chosidow', 'Affiliation': 'Department of Dermatology, Henri-Mondor University Hospital, Paris, France.'}, {'ForeName': 'Marie-Aleth', 'Initials': 'MA', 'LastName': 'Richard-Lallemand', 'Affiliation': 'CEReSS-EA 3279, Research Center in Health Services and Quality of Life Aix Marseille University, Dermatology Department, University Hospital Timone, Assistance Publique Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Rzeznik', 'Affiliation': 'private practice in Fécamp, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Amici', 'Affiliation': 'private practice in Cenon, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lair', 'Affiliation': 'private practice in Le Petit-Quevilly, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bechu', 'Affiliation': 'private practice in the Mathilde Private Clinic, Rouen, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Benichou', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1219, Normandie University, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Thill', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1219, Normandie University, Rouen, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Beylot-Barry', 'Affiliation': 'Department of Dermatology, INSERM U1053, Bordeaux University Hospital, Bordeaux, France.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.09.055']
2129,33016193,Time to First Culture Positivity for Gram-Negative Rods Resistant to Ceftriaxone in Critically Ill Adults.,"BACKGROUND
The optimal timing for the de-escalation of broad-spectrum antibiotics with activity against Pseudomonas aeruginosa and resistant Gram-negative rods (GNRs) in critically ill adults remains unknown.
RESEARCH QUESTION
We tested the hypothesis that cultures will identify GNRs that ultimately demonstrate resistance to ceftriaxone within 48 hours, potentially allowing safe de-escalation at this time point.
STUDY DESIGN AND METHODS
We conducted a secondary analysis of data from the Isotonic Solutions and Major Adverse Renal Events Trial: a pragmatic, cluster-randomized, multiple-crossover trial comparing balanced crystalloids versus saline for intravenous fluid administration in 15,802 critically ill adults at 5 intensive care units (ICUs) at Vanderbilt University Medical Center in Nashville, TN, USA. The primary endpoint was the time-to-positivity of respiratory and blood cultures that ultimately demonstrated growth of GNRs resistant to ceftriaxone. Multivariable logistic regression modeling was used to examine risk factors for the growth of cultures after 48 hours.
RESULTS
A total of 524 respiratory cultures had growth of GNRs, of which 284 (54.2%) had resistance to ceftriaxone. A total of 376 blood cultures grew GNRs, of which 70 (18.6%) had resistance to ceftriaxone. At 48 hours, 87% of respiratory cultures and 85% of blood cultures that ultimately grew GNRs resistant to ceftriaxone had demonstrated growth. Age, gender, predicted risk of inpatient mortality and prior use of antibiotics did not predict the growth of cultures after 48 hours.
INTERPRETATION
Among a cohort of critically ill adults, 13% of respiratory cultures and 15% of blood cultures that ultimately grew GNRs resistant to ceftriaxone did not demonstrate growth until at least 48 hours after collection. Further work is needed to determine the ideal time for critically ill adults to de-escalate from broad-spectrum antibiotics targeting Pseudomonas aeruginosa and extended-spectrum β-lactamase-producing gram-negative pathogens.",2021,"Age, gender, predicted risk of inpatient mortality and prior use of antibiotics did not predict the growth of cultures after 48 hours.
","['15,802 critically ill adults at 5 intensive care units (ICUs) at Vanderbilt University Medical Center in Nashville, TN, USA', 'Critically Ill Adults', 'critically ill adults']","['balanced crystalloids versus saline', 'ceftriaxone', 'Ceftriaxone']","['growth of GNRs', 'resistance to ceftriaxone', 'time-to-positivity of respiratory and blood cultures']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0200949', 'cui_str': 'Blood culture'}]",15802.0,0.146295,"Age, gender, predicted risk of inpatient mortality and prior use of antibiotics did not predict the growth of cultures after 48 hours.
","[{'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Buell', 'Affiliation': 'Department of Internal Medicine, 12328Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, 12328Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Noto', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, 12328Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, 12328Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, 12328Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Stollings', 'Affiliation': 'Department of Pharmaceutical Services, 12328Vanderbilt University Medical Center, Nashville, TN, USA.'}]",Journal of intensive care medicine,['10.1177/0885066620963903']
2130,33011429,Training older adults with virtual reality use to improve collision-avoidance behavior when walking through an aperture.,"Many older adults perform collision-avoidance behavior either insufficiently (i.e., frequent collision) or inefficiently (i.e., exaggerated behavior to ensure collision-avoidance). The present study examined whether a training system using virtual reality (VR) simulation enhanced older adults' collision-avoidance behavior in response to a VR image of an aperture during real walking. Twenty-five (n = 13 intervention group and n = 12 control group) older individuals participated. During training, a VR image of walking through an aperture was projected onto a large screen. Participants in the intervention group tried to avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures. Participants in the control group remained without body rotation while walking on the spot through a wide aperture. A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group. This suggests that the training led participants to modify their behavior to try to move efficiently during real walking. However, although not significant, collision rates also tended to be greater, suggesting that, at least for some participants, the modification required to avoid collision was too difficult. Transfer of the learned behavior using the VR environment to real walking is discussed.",2021,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","['Training older adults with virtual reality', 'n\u202f=\u202f12 control group) older individuals participated']","['avoid virtual collision with the minimum body rotation required to walk on the spot through a variety of narrow apertures', 'training system using virtual reality (VR) simulation']","['body rotation', 'collision rates', 'smaller body rotation angles']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",,0.0141464,"A comparison between pre-test and post-test performances in the real environment indicated that after the training, significantly smaller body rotation angles were observed in the intervention group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kondo', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan; Department of Physical Rehabilitation, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Suda', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Health Promotion Science, Tokyo Metropolitan University, Tokyo, Japan. Electronic address: higuchit@tmu.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104265']
2131,33012658,How long does the fertility-enhancing effect of hysterosalpingography with oil-based contrast last?,"RESEARCH QUESTION
Does the fertility-enhancing effect of tubal flushing during hysterosalpingography (HSG) with oil-based contrast change over time?
DESIGN
This was a secondary analysis of the H2Oil (long-term follow-up) study, a multicentre randomized controlled trial evaluating the effectiveness of oil-based and water-based contrast during HSG. The main outcome was ongoing pregnancy. Cox proportional hazards models for time to ongoing pregnancy were fitted over 3 years of follow-up.
RESULTS
Data on 1107 couples were available; 550 couples had oil-based contrast and 557 water-based contrast at HSG. Ongoing pregnancy rates after 3 years were 77% and 71%, respectively. Median follow-up was 9-10 months (5th-95th percentile: <1 to 36). The hazard ratio for ongoing pregnancy for oil versus water over 3 years of follow-up was 1.26 (95% confidence interval [CI] 1.10-1.45). The scaled Schoenfeld residual plots showed a decrease in hazard ratio that was linear with log-transformed time. After including an interaction with log-transformed time, the hazard ratio immediately after HSG was 1.71 (95% CI 1.27-2.31) and reduced to no effect (hazard ratio of 1) at approximately 2 years. There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
CONCLUSIONS
The hazard ratio for ongoing pregnancy of oil-based versus water-based contrast was 1.71 immediately after HSG, gradually decreasing and plateauing towards a hazard ratio of 1 (indicating no effect) after approximately 2 years. This supports the hypothesis that oil-based contrast might dislodge debris or mucus plugs from the Fallopian tubes, but this has yet to be definitively proved.",2020,"There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
",['1107 couples were available; 550 couples had oil-based contrast and 557 water-based contrast at HSG'],['oil-based and water-based contrast during HSG'],"['hazard ratio for ongoing pregnancy', 'Ongoing pregnancy rates', 'hazard ratio']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0020709', 'cui_str': 'Hysterosalpingography'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",1107.0,0.148688,"There was no evidence for a change in hazard ratio over time in a subgroup of women who experienced pain during HSG.
","[{'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Welie', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands. Electronic address: n.vanwelie@amsterdamumc.nl.'}, {'ForeName': 'Kimmy', 'Initials': 'K', 'LastName': 'Rosielle', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dreyer', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Joukje', 'Initials': 'J', 'LastName': 'van Rijswijk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelis B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'van Geloven', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Velja', 'Initials': 'V', 'LastName': 'Mijatovic', 'Affiliation': 'Department of Reproductive Medicine, Amsterdam UMC, Amsterdam Reproduction and Development Research Institute, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'van Eekelen', 'Affiliation': 'Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.038']
2132,33017784,Nitrous oxide analgesia for external cephalic version: A randomized controlled trial.,"STUDY OBJECTIVE
Our study sought to determine whether or not nitrous oxide analgesia decreases pain compared to oxygen placebo during external cephalic version for breech presentation. Procedural success may be limited by pain and anxiety. Although neuraxial anesthesia has been studied extensively for these procedures, many centers lack resources for routine use. Nitrous oxide is noninvasive, has minimal side effects and requires limited facilities. We hypothesized that its analgesic properties would decrease pain compared to oxygen placebo during external cephalic version.
DESIGN
Double-blinded randomized placebo-controlled trial.
SETTING
Labor and delivery triage room.
PATIENTS
Forty-eight patients, ≥18 years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version.
INTERVENTIONS
Patients undergoing external cephalic version were randomized to receive self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo.
MEASUREMENTS
The primary outcome measured was intra-procedural pain. Secondary outcomes were intra-procedural anxiety, patient satisfaction, and procedure difficulty.
MAIN RESULTS
Forty-eight patients were enrolled; 23 received nitrous oxide and 25 received oxygen. No difference was noted in mean pain scores (nitrous oxide 5.5 ± 2.3, placebo 5.4 ± 2.7, [CI 95% = -1.40, 1.51]; P = 0.943) or anxiety scores (nitrous oxide 1.6 ± 2.0, placebo 1.2 ± 1.8, [CI 95% = -0.74, 1.45]; P = 0.515). Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95% = -1.54, 1.66]; P = 0.944). There was a significant increase in the number of version attempts in the nitrous oxide group (nitrous oxide 3.9 ± 1.9, placebo 2.8 ± 1.4, [CI 95% = 0.05, 2]; P = 0.046). Patient satisfaction was significantly lower in the nitrous oxide group (nitrous oxide 4.3 ± 4.0, placebo 6.9 ± 3.6, [CI 95% = -4.93, -0.34]; P = 0.025).
CONCLUSION
Despite the desirable properties of nitrous oxide, there was no analgesic benefit over oxygen for external cephalic version. Its routine use for these procedures was not supported.",2020,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95% = -1.54, 1.66];","['external cephalic version', 'Forty-eight patients were enrolled; 23 received', 'Patients undergoing external cephalic version', ""Forty-eight patients, ≥18\xa0years of age, 37-weeks' gestation or beyond, singleton pregnancy, breech presentation, and American Society of Anesthesiology physical status I-III, having an external cephalic version"", 'Labor and delivery triage room']","['placebo', 'Nitrous oxide', 'nitrous oxide and 25 received oxygen', 'oxygen placebo', 'Nitrous oxide analgesia', 'self-administered 50% nitrous oxide/50% oxygen versus 100% oxygen placebo', 'nitrous oxide analgesia', 'nitrous oxide']","['mean pain scores', 'Patient satisfaction', 'anxiety scores', 'Procedural difficulty', 'intra-procedural anxiety, patient satisfaction, and procedure difficulty', 'number of version attempts', 'intra-procedural pain', 'pain']","[{'cui': 'C0410877', 'cui_str': 'External cephalic version'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006157', 'cui_str': 'Breech presentation'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0040861', 'cui_str': 'Triage'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3854439', 'cui_str': 'Procedural anxiety'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",48.0,0.62946,"Procedural difficulty (1-10 scale, 1 = very easy, 10 = extremely difficult) was not different between groups (nitrous oxide 6.1 ± 2.2, placebo 6.1 ± 3.2, [CI 95% = -1.54, 1.66];","[{'ForeName': 'Lacey E', 'Initials': 'LE', 'LastName': 'Straube', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Lacey_straube@med.unc.edu.'}, {'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Fardelmann', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kristen.fardelmann@yale.edu.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Penwarden', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: APenwarden@napaanesthesia.com.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: fei_chen@med.unc.edu.'}, {'ForeName': 'Elsje', 'Initials': 'E', 'LastName': 'Harker', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: elsje.harker@duke.unc.edu.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Redmon', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Benjamin.redmon@duke.edu.'}, {'ForeName': 'Quefeng', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'University of North Carolina School of Public Health, Department of Biostatistics, 135 Dauer Drive, Chapel Hill, NC 27599, USA. Electronic address: quefeng@email.unc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Strauss', 'Affiliation': 'University of North Carolina School of Medicine, Department of Obstetrics & Gynecology, 3009 Old Clinic Building, CB 7050, Chapel Hill, NC 27599, USA. Electronic address: Robert_strauss@med.unc.edu.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Smith', 'Affiliation': 'University of North Carolina School of Medicine, Department of Anesthesiology, N2198 UNC Hospitals CB#7010, Chapel Hill, NC 27599-7010, USA. Electronic address: Kathleen_a_smith@med.unc.edu.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110073']
2133,33022318,Treating tobacco dependence to aid re-employment among job-seekers: A randomized controlled trial.,"INTRODUCTION
U.S. reductions in smoking have not been experienced equally. Smoking prevalence is greater among persons of lower education, lower income, and unemployed. We evaluated whether a cessation intervention for job-seekers would result in significantly fewer cigarettes smoked per day and a greater likelihood of tobacco abstinence and re-employment, compared to the control condition at 6-months follow-up.
METHODS
Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018. Intention to quit smoking was not required. Participants were randomized to a brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline. Midstudy, 8-weeks of combination nicotine replacement was added to the intervention. Expired carbon monoxide and cotinine testing verified abstinence. Data were analyzed fall 2019.
RESULTS
Participants (N = 360; 70% men; 43% African American, 27% non-Hispanic Caucasian; 19% unhoused) averaged 12 cigarettes/day (SD = 6), 67% smoked within 30 min of wakening; 27% were in preparation stage to quit. During the 6-month study period, intervention participants were more likely to make a quit attempt (71% vs. 58%, p = .021) and reported significantly greater reduction in cigarettes/day than control participants (median reduction: 6.9 vs. 5.0, p = .038); however, bioconfirmed abstinence (3%) and re-employment (36%) did not differ by treatment group.
CONCLUSIONS
In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition. A priority group, further research is needed on smoking and re-employment.",2020,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","['Participants (N\u202f=\u202f360; 70% men; 43% African American, 27% non-Hispanic Caucasian', 'job-seekers', 'Unemployed, job-seekers who smoked daily were recruited from five employment development departments in the San Francisco Bay Area, October 2015 to February 2018']","['nicotine replacement', 'brief motivationally-tailored, computer-assisted counseling intervention or referred to a toll-free quitline']","['bioconfirmed abstinence', 'quit attempt', 'quit attempts and smoking reduction']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C3203003', 'cui_str': 'Bays'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}]",,0.0440133,"In a diverse sample with economic hardships, quit attempts and smoking reduction were greater in the intervention group; however, few achieved abstinence, and neither abstinence nor re-employment differed by condition.","[{'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America. Electronic address: jpro@stanford.edu.'}, {'ForeName': 'Cati', 'Initials': 'C', 'LastName': 'Brown-Johnson', 'Affiliation': 'Evaluation Sciences Unit, Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Adrienne S', 'Initials': 'AS', 'LastName': 'Lazaro', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chieng', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Stinson', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Anzai', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106259']
2134,33022321,Use of a GP-endorsed non-participant reminder letter to promote uptake of bowel scope screening: A randomised controlled trial in a hard-to-reach population.,"Previous research suggests that sending non-participants a reminder letter, 1 year after their initial invitation, can improve coverage for bowel scope screening (BSS), also known as flexible sigmoidoscopy screening. We hypothesised that adding a general practitioner's (GPs) endorsement to the reminder letter could improve coverage even further. We conducted a randomised controlled trial in North West London, UK. Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12 months prior to the trial period. Eligible adults were randomised in a 1:1 ratio to receive either a GP-endorsed reminder letter, or a standard reminder letter from June to August 2019. Logistic regression models were used to test the effect of the GP endorsement on attendance at BSS, adjusting for sex, clinical commissioning group, and local area socioeconomic deprivation. In total, 1200 participants were enrolled into the study and randomised to either the control (n = 600) or the intervention (n = 600) group. Those who received the GP-endorsed reminder letter were only slightly more likely to attend BSS than those who received the standard reminder letter (4% vs. 3%); this difference was not statistically significant (Adjusted OR = 1.30; 95% CI: 0.69, 2.43). Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS. One possible explanation for this is that the endorsement used was not personalised enough. Future research should examine stronger GP-endorsements or other methods to promote uptake.",2020,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"['Participants were screening-eligible men and women who had not responded to their initial BSS invitation at least 12\u202fmonths prior to the trial period', 'North West London, UK', 'Eligible adults', '1200 participants were enrolled into the study and randomised to either the control (n\u202f=\u202f600) or the intervention (n\u202f=\u202f600) group']","['GP-endorsed reminder letter, or a standard reminder letter from June to August 2019', 'GP-endorsed non-participant reminder letter']",[],"[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",[],1200.0,0.121819,Adding a GP-endorsement to the annual reminder letter did not have an effect on attendance at BSS.,"[{'ForeName': 'Aradhna', 'Initials': 'A', 'LastName': 'Kaushal', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK. Electronic address: aradhna.kaushal.14@ucl.ac.uk.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Hirst', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tookey', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marshall', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Prentice', 'Affiliation': ""St Mark's Bowel Cancer Screening Centre, London North West University Healthcare NHS Trust, Harrow, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Policy Research Unit in Cancer Awareness, Screening and Early Diagnosis, Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Wagner', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106268']
2135,33022324,Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.,"This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m 2 , p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.",2020,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","['356 (86%) participants completed the 18-month visit', 'African American older adults in the F&S', '413 overweight/obese participants with OA, ≥60\u202fyears old and primarily African American', 'overweight/obese older adults with osteoarthritis']","['Plus (F&S', 'Fit & Strong', 'physical activity program to Fit & Strong', 'standard Fit & Strong', 'standard F&S!, F&S', 'F&S']","['BMI', 'weight, waist circumference, and lower extremity strength', 'weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression', 'waist circumference', 'lower extremity strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",413.0,0.0535567,"Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.","[{'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Fitzgibbon', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Pediatrics, University of Illinois at Chicago, 840 South Wood Street, Chicago, IL 60612, United States of America. Electronic address: mlf@uic.edu.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tussing-Humphreys', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; University of Illinois Cancer Center, 818 South Wolcott Avenue, Chicago, IL 60612, United States of America; Department of Medicine, University of Illinois at Chicago, 808 South Wood Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Schiffer', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Smith-Ray', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Health Analytics, Research and Reporting, Walgreen Co., 102 Wilmot Road, Deerfield, IL 60015, United States of America.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Department of Kinesiology and Nutrition, University of Illinois at Chicago, 1919 West Taylor Street, Chicago, IL 60612, United States of America.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DeMott', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Berbaum', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Hughes', 'Affiliation': 'Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Center for Research on Health and Aging, University of Illinois at Chicago, 1747 West Roosevelt Road, Chicago, IL 60608, United States of America; Division of Community Health Sciences, University of Illinois at Chicago, 1603 West Taylor Street, IL 60612, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106267']
2136,33022345,Effects of tDCS on neuroplasticity and inflammatory biomarkers in bipolar depression: Results from a sham-controlled study.,"OBJECTIVES
We investigated the role of peripheral biomarkers associated with neuroplasticity and immune-inflammatory processes on the effects of transcranial direct current stimulation (tDCS), a safe, affordable, and portable non-invasive neuromodulatory treatment, in bipolar depression.
METHODS
This is an exploratory analysis using a dataset from the sham-controlled study the Bipolar Depression Electrical Treatment Trial (BETTER)(clinicaltrials.govNCT02152878). Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode, randomized to 12 bifrontal active or sham tDCS sessions over a 6-week treatment course. Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint. We performed analyses unadjusted for multiple testing to evaluate whether baseline biomarkers were predictive for depression improvement and changed during treatment using linear regression models.
RESULTS
A time x group interaction (Cohen's d: -1.16, 95% CI = -1.96 to -0.3, p = .005) was found for IL-8, with greater reductions after active tDCS. Higher baseline IL-6 plasma levels was associated with symptomatic improvement after tDCS (F (1,43) = 5.43; p = .025). Other associations were not significant.
CONCLUSIONS
Our exploratory findings suggested that IL-6 is a potential predictor of tDCS response and IL-8 might decrease after tDCS; although confirmatory studies are warranted due to the multiplicity of comparisons.",2020,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","['bipolar depression', 'Participants were 52 adults with type I or II bipolar disorder in a moderate-to-severe depressive episode']","['12 bifrontal active or sham tDCS sessions', 'transcranial direct current stimulation (tDCS', 'tDCS']","['Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2', 'neuroplasticity and inflammatory biomarkers', 'Higher baseline IL-6 plasma levels']","[{'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0445448', 'cui_str': 'Bifrontal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450499', 'cui_str': 'ST2'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",52.0,0.250759,"Plasma levels of brain derived neurotrophic factor (BDNF), glial cell derived neurotrophic factor (GDNF), interleukins (IL) 2, 4, 6, 8, 10, 18, 33, 1β, 12p70, 17a, interferon gamma (IFN), tumor necrosis factor alpha (TNF) and its soluble receptors 1 and 2, ST2, and KLOTHO were investigated at baseline and endpoint.","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Goerigk', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany; Hochschule Fresenius, University of Applied Sciences, Munich, Germany.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cretaz', 'Affiliation': 'ECT Service, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Sampaio-Junior', 'Affiliation': 'Private practice, São Paulo, Brazil.'}, {'ForeName': 'Érica Leandro Marciano', 'Initials': 'ÉLM', 'LastName': 'Vieira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Wagner', 'Initials': 'W', 'LastName': 'Gattaz', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Izio', 'Initials': 'I', 'LastName': 'Klein', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Beny', 'Initials': 'B', 'LastName': 'Lafer', 'Affiliation': 'Bipolar Disorder Research Program, Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antônio Lúcio', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Interdisciplinary Laboratory of Medical Investigation, Faculdade de Medicina, Universidade Federal de Minas Gerais, Minas Gerais, Brazil; Neuropsychiatry Program, Department of Psychiatry and Behavioral Science, UT Health, Houston, United States of America.'}, {'ForeName': 'André F', 'Initials': 'AF', 'LastName': 'Carvalho', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Healthy (CAMH), Toronto, ON, Canada.'}, {'ForeName': 'Paulo A', 'Initials': 'PA', 'LastName': 'Lotufo', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Isabela M', 'Initials': 'IM', 'LastName': 'Benseñor', 'Affiliation': 'Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bühner', 'Affiliation': 'Department of Psychological Methodology and Assessment, Ludwig-Maximilians-University, Munich, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'André R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Laboratory of Neurosciences (LIM-27), Instituto Nacional de Biomarcadores em Neuropsiquiatria (INBioN), Department and Institute of Psychiatry, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Internal Medicine, Faculdade de Medicina da Universidade de São Paulo & Hospital Universitário, Universidade de São Paulo, Av. Prof Lineu Prestes 2565, 05508-000 São Paulo, Brazil. Electronic address: brunoni@usp.br.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110119']
2137,33031809,Cross-Linking Assisted Infection Reduction: One-year Follow-up of a Randomized Clinical Trial Evaluating Cross-Linking for Fungal Keratitis.,,2020,,['Fungal Keratitis'],['Cross-Linking Assisted Infection Reduction (CLAIR'],[],"[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",[],,0.0700031,,"[{'ForeName': 'N Venkatesh', 'Initials': 'NV', 'LastName': 'Prajna', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Radhakrishnan', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Prajna', 'Initials': 'P', 'LastName': 'Lalitha', 'Affiliation': 'Aravind Eye Hospital, Madurai, India.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Zijun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Tom M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California; UCSF Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Proctor Foundation, University of California San Francisco, San Francisco, California; UCSF Department of Ophthalmology, University of California San Francisco, San Francisco, California; Division of Research, Kaiser Permanente Northern California, Redwood City, California. Electronic address: jennifer.rose.nussbaumer@gmail.com.'}]",Ophthalmology,['10.1016/j.ophtha.2020.09.042']
2138,33034651,"Evaluation of a Novel Decision Guide ""Go to the Hospital or Stay Here?"" for Nursing Home Residents and Families: A Randomized Trial.","Initiatives to reduce potentially preventable hospitalizations of nursing home residents have focused on staff response to changes in condition and advance care planning. Yet, resident and family insistence on transfer has been one of the most intractable sources of these hospitalizations, although not the target of active intervention until now. Consented residents and family members in the intervention group received a newly developed decision aid entitled, ""Go to the Hospital or Stay Here?,"" providing information on the risks and benefits of transfer versus remaining in the nursing home. This person-centered decision aid was developed from the results of 271 interviews of residents, families, and providers to identify what they wanted to know and any misunderstandings surrounding the transfer process. Engaging residents in the decision respects their right to participate and provides the information they need to make a deliberative decision. The intervention group showed a gain in knowledge and reduction in decisional conflict but reported decreased decisional preparation. There was no decrease in transfers compared to the control group. Evaluation of the decision guide by residents and families was positive.
TARGETS
Nursing home residents and their family members.
INTERVENTION
To provide information regarding the decision to stay in the nursing home or transfer to acute care due to a change in condition.
MECHANISMS OF ACTION
Decision aid ""Go the ""Hospital or Stay Here?"" to impart knowledge regarding the decision to remain in the nursing home or transfer to acute care.
OUTCOMES
Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation. No reduction in transfers was found. Residents and families rated the Guide as very helpful. [Research in Gerontological Nursing, 13(6), 309-319.].",2020,"OUTCOMES
Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation.","['Nursing Home Residents and Families', 'Nursing home residents and their family members']","['newly developed decision aid entitled, ""Go to the Hospital or Stay Here?,"" providing information on the risks and benefits of transfer versus remaining in the nursing home']","['decisional preparation', 'transfers', 'gain in knowledge and reduction in decisional conflict', ""residents' and family members' knowledge and decrease decisional conflict""]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0154065,"OUTCOMES
Use of the Guide was found to increase residents' and family members' knowledge and decrease decisional conflict, but it did not increase decisional preparation.","[{'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Tappen', 'Affiliation': ''}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Worch', 'Affiliation': ''}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hain', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20201002-01']
2139,33020447,"Effectiveness of ""Hand Hygiene Fun Month"" for Kindergarten Children: A Pilot Quasi-Experimental Study.","Early childhood is a formative period during which healthy habits are developed, including proper hand hygiene practices. The aim of this quasi-experimental study was to determine the effectiveness of a 4-week series of educational sessions that consider the cognitive developmental stage of children on increasing their knowledge and promoting hand hygiene practices. The intervention group ( n = 33) observed the hand hygiene program, whereas another group served as the waitlist control ( n = 20). Creative activities were planned for the illustration of hand hygiene concepts in terms of ""right moments"", ""right steps"", and ""right duration"". Hand sanitizer coverage was evaluated using a hand scanner. After the intervention, the experimental group had higher knowledge level toward hand hygiene than the control group ( p < 0.001). Significant improvements in hand hygiene performance at the left palm and dorsum ( p < 0.05), right palm ( p < 0.05), and overall hand coverage ( p < 0.05) were observed in the experimental group. The study demonstrated that the knowledge and proper hand hygiene (HH) practice of children can be positively influenced by the use of an age-appropriate education program. The results of this study have implications for school health educators and parents for promoting HH practices among children at home and at the school level.",2020,"Significant improvements in hand hygiene performance at the left palm and dorsum ( p < 0.05), right palm ( p < 0.05), and overall hand coverage ( p < 0.05) were observed in the experimental group.","['Kindergarten Children', 'school health educators and parents for promoting HH practices among children at home and at the school level']","['educational sessions', 'Hand Hygiene Fun Month', 'hand hygiene program, whereas another group served as the waitlist control']","['hand hygiene performance', 'overall hand coverage', 'knowledge level toward hand hygiene']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4708552', 'cui_str': 'School health educator'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}]",,0.0163116,"Significant improvements in hand hygiene performance at the left palm and dorsum ( p < 0.05), right palm ( p < 0.05), and overall hand coverage ( p < 0.05) were observed in the experimental group.","[{'ForeName': 'Lorna Kwai Ping', 'Initials': 'LKP', 'LastName': 'Suen', 'Affiliation': 'Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Janet Pui Lee', 'Initials': 'JPL', 'LastName': 'Cheung', 'Affiliation': 'Squina International Centre for Infection Control, School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}]",International journal of environmental research and public health,['10.3390/ijerph17197264']
2140,33026630,The Impact of OnabotulinumtoxinA vs. Placebo on Efficacy Outcomes in Headache Day Responder and Nonresponder Patients with Chronic Migraine.,"INTRODUCTION
The phase 3 PREEMPT trials demonstrated efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. OnabotulinumtoxinA significantly reduced headache frequency from baseline vs. placebo at 24 weeks; however, this measure may not fully capture the benefits of treatment. We evaluated the impact of onabotulinumtoxinA on patient-reported outcomes according to headache responder status.
METHODS
A post hoc analysis pooled 24-week data from the placebo-controlled, randomized, double-blind treatment phases of the PREEMPT trials. Patients were stratified by randomized treatment (onabotulinumtoxinA vs. placebo) and headache day responder status (responder vs. nonresponder). Headache day responders had a ≥ 50% headache day reduction from baseline measured at weeks 21-24. Outcomes evaluated were patient-reported reductions in moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire. Missing values were estimated using a modified last-observation-carried-forward approach.
RESULTS
In the pooled analysis population (N = 1384; onabotulinumtoxinA, n = 688; placebo, n = 696), headache day responder rates were 308/688 (45%) for onabotulinumtoxinA- and 238/696 (34%) for placebo-treated patients. At 24 weeks compared with baseline, onabotulinumtoxinA nonresponders showed significantly (all P < 0.01) greater mean (standard error) reductions vs. placebo nonresponders in moderate-to-severe headache days (- 3.5 [0.2] vs. - 2.4 [0.2]) and Headache Impact Test scores (- 2.3 [0.3] vs. - 0.8 [0.2]), and greater mean improvements in Migraine-Specific Quality of Life Questionnaire domains (Restrictive, 8.8 [1.0] vs. 2.9 [0.8]; Preventive, 6.0 [1.0] vs. 1.8 [0.8]; Emotional, 8.5 [1.3] vs. 2.8 [1.1]). Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
CONCLUSIONS
Relative to placebo nonresponders, onabotulinumtoxinA nonresponders experienced significant reductions in moderate-to-severe headache days and disability and improvement in quality of life, implying that the full benefits of onabotulinumtoxinA are not captured by headache day reduction.
TRIAL REGISTRATION
ClinicalTrials.gov identifiers, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).",2020,"Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
","['Headache Day Responder and Nonresponder Patients with Chronic Migraine', 'adults with chronic migraine']","['randomized treatment (onabotulinumtoxinA vs. placebo', 'onabotulinumtoxinA', 'placebo', 'OnabotulinumtoxinA vs. Placebo', 'OnabotulinumtoxinA']","['Moderate-to-severe headache day and headache impact differences', 'Headache Impact Test scores', 'Migraine-Specific Quality of Life Questionnaire domains', 'headache day responder rates', 'moderate-to-severe headache days and disability', 'headache frequency', 'moderate-to-severe headache days, Headache Impact Test, and Migraine-Specific Quality of Life Questionnaire', 'quality of life', 'efficacy and tolerability']","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.433509,"Moderate-to-severe headache day and headache impact differences between nonresponder groups were evident at week 4 and sustained through week 24.
","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA. stephen.silberstein@jefferson.edu.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Manack Adams', 'Affiliation': 'Allergan, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Pain and therapy,['10.1007/s40122-020-00199-9']
2141,33026631,Benefits Beyond Headache Days With OnabotulinumtoxinA Treatment: A Pooled PREEMPT Analysis.,"INTRODUCTION
The double-blind, phase 3 PREEMPT trials demonstrated the efficacy and tolerability of onabotulinumtoxinA for headache prevention in adults with chronic migraine. This post hoc analysis evaluated the effect of onabotulinumtoxinA on clinically meaningful changes in headache severity, headache-related impact, and quality of life.
METHODS
Pooled, 24-week data were used to determine percentages of patients meeting responder criteria for the change in headache days (≥ 50% reduction in headache-day frequency), Headache Impact Test (HIT-6; ≥ 5-point improvement), MSQ Role Function-Restrictive (MSQ-RFR; ≥ 10.9-point improvement), and Average Daily Headache Severity (ADHS; ≥ 1-point improvement on a 4-point ordinal scale [0 = no pain, 3 = severe pain]).
RESULTS
In the pooled analysis population (N = 1384; onabotulinumtoxinA, n = 688; placebo, n = 696), significantly more patients treated with onabotulinumtoxinA compared with placebo were responders on HIT-6 (40.8 vs. 25.3%), MSQ-RFR (59.0 vs. 40.2%), and ADHS (35.5 vs. 22.4%) measures, and achieved traditional ≥ 50% reduction in headache days (44.8 vs. 34.2%; all P < 0.001). At least one responder criterion was met by 72.1% and 56.6% of onabotulinumtoxinA- and placebo-treated patients, respectively; all four were met by 20.4% and 8.6%, respectively (P < 0.001). Linear regression analysis showed that approximately 20% of the variance in HIT-6 and MSQ-RFR improvement was explained by improvement in headache days.
CONCLUSIONS
Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life. While 45% of patients met responder criteria for monthly headache days, over 70% had clinically meaningful improvements on at least one outcome measure.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT00156910 (PREEMPT 1) and NCT00168428 (PREEMPT 2).",2020,"CONCLUSIONS
Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life.",['adults with chronic migraine'],"['onabotulinumtoxinA- and placebo', 'placebo', 'onabotulinumtoxinA']","['headache severity and headache-related impact, and improved quality of life', 'headache days', 'headache-day frequency), Headache Impact Test (HIT-6;\u2009≥\u20095-point improvement), MSQ Role Function-Restrictive (MSQ-RFR', 'ADHS', 'HIT-6 and MSQ-RFR improvement', '4-point ordinal scale [0\u2009=\u2009no pain, 3\u2009=\u2009severe pain', 'Average Daily Headache Severity (ADHS;\u2009≥', 'MSQ-RFR', 'efficacy and tolerability', 'headache severity, headache-related impact, and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3661947', 'cui_str': 'Daily headache'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.254152,"CONCLUSIONS
Treatment with onabotulinumtoxinA for 24 weeks was associated with clinically meaningful benefits beyond reduction in headache days; including reductions in headache severity and headache-related impact, and improved quality of life.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, University of Duisburg-Essen, Essen, Germany. h.diener@uni-essen.de.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Manack Adams', 'Affiliation': 'Allergan, an AbbVie Company, Irvine, CA, USA.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'DeGryse', 'Affiliation': 'AbbVie, Irvine, CA, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]",Pain and therapy,['10.1007/s40122-020-00198-w']
2142,33031148,Powering Bias and Clinically Important Treatment Effects in Randomized Trials of Critical Illness.,"OBJECTIVES
Recurring issues in clinical trial design may bias results toward the null, yielding findings inconclusive for treatment effects. This study evaluated for powering bias among high-impact critical care trials and the associated risk of masking clinically important treatment effects.
DESIGN, SETTING, AND PATIENTS
Secondary analysis of multicenter randomized trials of critically ill adults in which mortality was the main endpoint. Trials were eligible for inclusion if published between 2008 and 2018 in leading journals. Analyses evaluated for accuracy of estimated control group mortality, adaptive sample size strategy, plausibility of predicted treatment effect, and results relative to the minimal clinically important difference. The main outcome was the mortality risk difference at the study-specific follow-up interval.
INTERVENTIONS
None.
MEASUREMENTS AND MAIN RESULTS
Of 101 included trials, 12 met statistical significance for their main endpoint, five for increased intervention-associated mortality. Most trials (77.3%) overestimated control group mortality in power calculations (observed minus predicted difference, -6.7% ± 9.8%; p < 0.01). Due to this misestimation of control group mortality, in 14 trials, the intervention would have had to prevent at least half of all deaths to achieve the hypothesized treatment effect. Seven trials prespecified adaptive sample size strategies that might have mitigated this issue. The observed risk difference for mortality fell within 5% of predicted in 20 trials, of which 16 did not reach statistical significance. Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit. Most trials (67.3%) could not exclude clinically important treatment benefit or harm.
CONCLUSIONS
The design of most high-impact critical care trials biased results toward the null by overestimating control group mortality and powering for unrealistic treatment effects. Clinically important treatment effects often cannot be excluded.",2020,"Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit.","['Trials were eligible for inclusion if published between 2008 and 2018 in leading journals', 'critically ill adults']",[],"['mortality risk difference at the study-specific follow-up interval', 'mortality', 'mortality fell']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",,0.394729,"Half of trials (47.0%) were powered for an absolute risk reduction greater than or equal to 10%, but this effect size was observed in only three trials with a statistically significant treatment benefit.","[{'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Abrams', 'Affiliation': '1Center for Acute Respiratory Failure and Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY. 2Division of Pulmonary and Critical Care Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA. 3Department of Medicine, Columbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Sydney B', 'Initials': 'SB', 'LastName': 'Montesi', 'Affiliation': ''}, {'ForeName': 'Sarah K L', 'Initials': 'SKL', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Daniel K', 'Initials': 'DK', 'LastName': 'Manson', 'Affiliation': ''}, {'ForeName': 'Kaitlin M', 'Initials': 'KM', 'LastName': 'Klipper', 'Affiliation': ''}, {'ForeName': 'Meredith A', 'Initials': 'MA', 'LastName': 'Case', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brodie', 'Affiliation': ''}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Beitler', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004568']
2143,33032180,A prospective randomized controlled trial on the value of prophylactic oral nutritional supplementation in locally advanced nasopharyngeal carcinoma patients receiving chemo-radiotherapy.,"OBJECTIVES
We investigated the effect of prophylactic oral nutrition supplements (ONS) in locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT).
METHODS
Eligible patients were randomly assigned to an intervention or control group. Patients in the intervention group were supported with prophylactic ONS from the beginning of CCRT. The control group received nutritional support only when necessary. Bodyweight, hematological indexes, nutritional status, and quality of life were measured at baseline and before, during, and after RT.
RESULTS
We evaluated 114 patients from October 2016 to May 2018. More than half of patients experienced significant weight loss during CCRT, which continued for three months after radiotherapy (RT). Compared to baseline, the rate of weight loss ≥ 5% before, during, at the end of RT, and one and three months after RT were 3.5%, 28.9%, 51.8%, 61.4%, and 61.4%, respectively. Nutritional status and global health status scores progressively decreased during treatment. The rate of RT interruption was higher in the control group than in the intervention group (7.14% vs. 0%, χ 2 = 4.29, P = 0.04). More patients experienced concurrent chemotherapy interruption in the control group than in the intervention group (28.57% vs 10.34%, χ 2 = 6.08, P = 0.01). There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
CONCLUSIONS
Malnutrition and weight loss progressively increased during treatment. Prophylactic ONS can improve tolerance to CCRT, but it offers no advantage on short-term weight loss or nutritional assessment scores.",2020,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","['locally advanced nasopharyngeal carcinoma patients receiving', 'Eligible patients', 'locally advanced nasopharyngeal carcinoma patients receiving neoadjuvant chemotherapy and concurrent chemoradiotherapy (CCRT', '114 patients from October 2016 to May 2018']","['Prophylactic ONS', 'prophylactic oral nutrition supplements (ONS', 'chemo-radiotherapy', 'prophylactic ONS', 'nutritional support', 'prophylactic oral nutritional supplementation']","['weight loss', 'Nutritional status and global health status scores', 'concurrent chemotherapy interruption', 'rate of weight loss', 'rate of RT interruption', 'Bodyweight, hematological indexes, nutritional status, and quality of life', 'weight loss, nutritional status, quality of life, and global health status']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C4708785', 'cui_str': '114'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",114.0,0.0467853,"There were no significant differences in weight loss, nutritional status, quality of life, and global health status between two groups.
","[{'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: huangshuang@zjcc.org.cn.'}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Piao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Caineng', 'Initials': 'C', 'LastName': 'Cao', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': 'Hangzhou YITU Healthcare Technology Co., Ltd, Xihu District, Hangzhou 310012, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Shu', 'Affiliation': 'The 2nd Clinical Medical College of Zhejiang, Chinese Medical University, No. 534, Binwen Road, Hangzhou 310053, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Hua', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Qiaoying', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Head and Neck Radiotherapy, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Institute of Cancer and Basic Medicine (ICBM) Chinese Academy of Sciences, Zhejiang Province Key Laboratory of Radiation Oncology, 1st Banshan Road, Gongshu District, Hangzhou 310000, China. Electronic address: chenyy@zjcc.org.cn.'}]",Oral oncology,['10.1016/j.oraloncology.2020.105025']
2144,33035274,"Programmatic evaluation of feasibility and efficiency of at birth and 6-week, point of care HIV testing in Kenyan infant.","BACKGROUND
Testing infants at birth and with more efficient point of care (POC) HIV diagnostic can streamline EID and expedite infant ART initiation. We evaluated the implementation of at birth and 6-week POC testing to assess the effectiveness and feasibility when implemented by existing hospital staff in Kenya.
METHODS
Four government hospitals were randomly assigned to receive a GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing. All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age. The primary outcome was repeat POC testing, defined as testing both at birth and 6-weeks of age. Secondary outcomes included predictors of repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities).
RESULTS
Of 626 enrolled infants, 309 (49.4%) received repeat POC testing, 115 (18.4%) were lost to follow up after an at-birth test, 120 (19.2%) received POC testing at 6-weeks only, 80 (12.8%) received no POC testing, and 2 (0.3%) received delayed POC testing (>12 weeks of age). Three (0.4%) were identified as HIV-positive. Of the total 853 POC tests run at birth (n = 424) or 6-weeks (n = 429), 806 (94.5%) had a valid result documented and 792 (98.3%) results had documented maternal notification. Mean time from sample collection to notification was 1.08 days, with 751 (94.8%) notifications on the same day as sample collection. Machine error rates at birth and 6-weeks were 8.5% and 2.5%, respectively. A total of 198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing.
DISCUSSION
At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff. However, maternal disengagement and missed opportunities for testing must be addressed to realize the full benefits of at birth POC testing.",2020,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","['Four government hospitals', 'Kenyan infant', 'All HIV-exposed infants enrolled were eligible to receive POC testing at birth and 6-weeks of age', '626 enrolled infants, 309 (49.4%) received', '198 infants presented for care (48 at birth; 150 at 6-weeks) without receiving a POC test, representing missed opportunities for testing']","['GeneXpert HIV-1 Qual (n = 2) or Alere m-PIMA (n = 2) machine for POC testing', 'delayed POC testing']","['Machine error rates', 'maternal notification', 'repeat POC testing', 'repeat POC testing, defined as testing both at birth and 6-weeks of age', 'Mean time', 'POC testing', 'repeat POC testing, POC efficiency (turnaround times of key services), and operations (failed POC results, missed opportunities']","[{'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C2924612', 'cui_str': 'Cephalometric point A'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0722638', 'cui_str': 'Pima brand of potassium iodide'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",626.0,0.0931997,"At birth POC testing can streamline infant HIV diagnosis, expedite ART initiation and can be implemented by existing hospital staff.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wexler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Niaman', 'Initials': 'N', 'LastName': 'Nazir', 'Affiliation': 'Department of Preventive Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Maloba', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Children's Mercy Kansas City, Health Services and Outcomes Research, Kansas City, MO, United States of America.""}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Gautney', 'Affiliation': 'Global Health Innovations, Dallas, TX, United States of America.'}, {'ForeName': 'Nicodemus', 'Initials': 'N', 'LastName': 'Maosa', 'Affiliation': 'Global Health Innovations-Kenya, Nairobi, Kenya.'}, {'ForeName': 'Shadrack', 'Initials': 'S', 'LastName': 'Babu', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Muchoki', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Natabhona', 'Initials': 'N', 'LastName': 'Mabachi', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Lwembe', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Finocchario-Kessler', 'Affiliation': 'Department of Family Medicine, University of Kansas Medical Center, Kansas City, KS, United States of America.'}]",PloS one,['10.1371/journal.pone.0240621']
2145,33025342,"Multiple-Dose Pharmacokinetics of Ozanimod and its Major Active Metabolites and the Pharmacodynamic and Pharmacokinetic Interactions with Pseudoephedrine, a Sympathomimetic Agent, in Healthy Subjects.","INTRODUCTION
The aims of this study were to characterize the multiple-dose pharmacokinetics (PK) of ozanimod's major active metabolites (CC112273 and CC1084037) and to evaluate the pharmacodynamic and PK interactions with pseudoephedrine (PSE).
METHODS
In this phase 1, single-center, randomized, double-blind, placebo-controlled study, 56 healthy adult subjects were randomized to receive either placebo or ozanimod once daily for 30 days (0.23 mg on days 1-4, 0.46 mg on days 5-7, 0.92 mg on days 8-10, and 1.84 mg on days 11-30). On day 30, a single oral dose of PSE 60 mg was co-administered with placebo or ozanimod. Maximum time-matched change in systolic blood pressure (SBP) from baseline (day 29) following PSE administration on day 30 was calculated. Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE were estimated using noncompartmental methods.
RESULTS
Fifty-two subjects (92.9%) completed the study. Following multiple dosing, approximately 94% of circulating total active drug exposure was represented by ozanimod (6%), CC112273 (73%), and CC1084037 (15%). Exposures of CC112273 and CC1084037 were highly correlated. Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE. Ozanimod also had no effect on the PK of PSE. Co-administration of ozanimod with a single dose of PSE in healthy subjects was generally well tolerated. While CC112273 and CC1084037 selectively inhibited monoamine oxidase (MAO)-B in vitro, both active metabolites do not inhibit platelet MAO-B activity in vivo.
CONCLUSION
Concomitant administration of ozanimod with PSE, a sympathomimetic agent, did not potentiate the effects on blood pressure.
TRIAL REGISTRATION
NCT03644576.",2020,Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE.,"['56 healthy adult subjects', 'Fifty-two subjects (92.9%) completed the study', 'healthy subjects', 'Healthy Subjects']","['PSE', 'Pseudoephedrine', 'placebo or ozanimod', 'PSE 60\xa0mg was co-administered with placebo or ozanimod', 'placebo', 'ozanimod', 'pseudoephedrine (PSE', 'ozanimod with PSE']","['blood pressure', 'circulating total active drug exposure', 'PK of PSE', 'Maximum time-matched change in systolic blood pressure (SBP', 'Plasma PK parameters for ozanimod, CC112273, CC1084037, and PSE', 'tolerated', 'Mean maximum time-matched change from baseline for SBP']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0989419', 'cui_str': 'Pseudoephedrine 60 MG'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",56.0,0.322654,Mean maximum time-matched change from baseline for SBP was not significantly different between ozanimod + PSE and placebo + PSE.,"[{'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA. dr.jtran@gmail.com.'}, {'ForeName': 'Peijin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Apex Biostatistics, Inc, New Hill, NC, USA.'}, {'ForeName': 'Atalanta', 'Initials': 'A', 'LastName': 'Ghosh', 'Affiliation': 'Biometrics and Data Sciences, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Syto', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Nonclinical Research and Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Translational Medicine, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmisano', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics and Research and Early Development, Bristol-Myers Squibb Company, Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-020-01500-0']
2146,33027167,Predictors of Long-Term Pain After Hip Arthroplasty in Patients With Femoral Neck Fractures: A Cohort Study.,"OBJECTIVES
To identify factors associated with the development of prolonged pain after hip fracture surgery.
DESIGN
Secondary analysis of a randomized controlled trial.
SETTING
Eighty hospitals in 10 countries.
PATIENTS/PARTICIPANTS
One thousand four hundred forty-one hip fracture patients in the HEALTH trial.
INTERVENTIONS
Total hip arthroplasty or hemiarthroplasty.
MAIN OUTCOME MEASURES
Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale with scores ≥2) at 12 and 24 months after hip arthroplasty.
RESULTS
Of 840 and 726 patients with complete baseline data and outcomes at 1-year and 2-year follow-up, 96 (11.4%) and 80 (11.0%) reported moderate-to-severe pain, respectively. An increased risk of pain at both 1 and 2 years after surgery was associated with reporting moderate-to-severe hip pain before fracture [absolute risk increase (ARI) 15.3%, 95% confidence interval (CI) 6.44%-24.35%; ARI 12.5%, 95% CI 2.85%-22.12%, respectively] and prefracture opioid use (ARI 15.6%, 95% CI 5.41%-25.89%; ARI 21.1%; 95% CI 8.23%-34.02%, respectively). Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%). A greater risk of persistent pain at 2 years was associated with younger age (≤79-year-old; ARI 6.3%; 95% CI 2.67%-9.91%) and higher prefacture functional status (ARI 10.7%; 95% CI 3.80%-17.64%).
CONCLUSIONS
Among hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery. Younger age, female sex, higher functioning prefracture, living with hip pain prefracture, and use of prescription opioids were predictive of persistent pain.
LEVEL OF EVIDENCE
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%).","['Eighty hospitals in 10 countries', 'One thousand four hundred forty-one hip fracture patients in the HEALTH trial', 'hip fracture patients undergoing arthroplasty, approximately one in 10 will experience moderate-to-severe pain up to 2 years after surgery', 'Patients With Femoral Neck Fractures', 'Total hip arthroplasty or hemiarthroplasty']",['Hip Arthroplasty'],"['Moderate-to-severe pain (at least 2 activities on the Western Ontario and McMaster Universities Osteoarthritis questionnaire pain subscale', 'prefacture functional status', 'risk of persistent pain', 'Predictors of Long-Term Pain', 'moderate-to-severe pain', 'prefracture opioid use', 'risk of pain']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0186193', 'cui_str': 'Repair of hip'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",1441.0,0.388196,"Female sex was associated with an increased risk of persistent pain at 1 year (ARI 6.2%, 95% CI 3.53%-8.84%).","[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Noori', 'Affiliation': 'aDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,Ontario, Canada; bThe Michael G. DeGroote National Pain Center, McMaster University, Hamilton, ON, Canada; cDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; dDepartment of Surgery, University of Western Ontario, London, ON, Canada; eDepartment of Orthopedic and Trauma Surgery, OLVG, Amsterdam and Leiden University Medical Center, Leiden, the Netherlands; fDivision of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway; gDepartment of Anesthesia, McMaster University, Hamilton, ON, Canada; and hThe Chronic Pain Centre of Excellence for Canadian Veterans, Hamilton, ON, Canada.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': ''}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': ''}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Axelrod', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': ''}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': ''}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Busse', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001929']
2147,33027168,Who Did the Arthroplasty? Hip Fracture Surgery Reoperation Rates are Not Affected by Type of Training-An Analysis of the HEALTH Database.,"OBJECTIVES
This study compares outcomes for patients with displaced femoral neck fractures undergoing hemiarthroplasty (HA) or total hip arthroplasty (THA) by surgeons of different fellowship training.
DESIGN
Retrospective review of HEALTH trial data.
SETTING
Eighty clinical sites across 10 countries.
PATIENTS/PARTICIPANTS
One thousand four hundred forty-one patients ≥50 years with low-energy hip fractures requiring surgical intervention.
INTERVENTION
Patients were randomized to either HA or THA groups in the initial data set. Surgeons' fellowship training was ascertained retrospectively, and outcomes were compared.
MAIN OUTCOME MEASUREMENTS
The main outcome was an unplanned secondary procedure at 24 months. Secondary outcomes included death, serious adverse events, prosthetic joint infection (PJI), dislocation, discharge disposition, and use of ambulatory devices postoperatively.
RESULTS
There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon. There were significantly higher odds of being discharged to a facility rather than home in patients who underwent surgery by a surgeon with no fellowship training compared with arthroplasty-fellowship-trained surgeons (P = 0.03).
CONCLUSIONS
Arthroplasty for hip fracture can be performed by all orthopaedic surgeons with equivalent reoperation rates. Infection prevention strategies and use of ""care pathways"" by arthroplasty-fellowship-trained surgeons may account for the lower risk of PJI and higher rate of discharge to home. The authors advocate for the use of evidence-based infection prevention initiatives and standardized care pathways in this patient population.
LEVEL OF EVIDENCE
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon.","['Eighty clinical sites across 10 countries', 'patients with displaced femoral neck fractures undergoing hemiarthroplasty (HA) or total hip arthroplasty (THA) by surgeons of different fellowship training', 'One thousand four hundred forty-one patients ≥50 years with low-energy hip fractures requiring surgical intervention']",['HA or THA'],"['Hip Fracture Surgery Reoperation Rates', 'death, serious adverse events, prosthetic joint infection (PJI), dislocation, discharge disposition, and use of ambulatory devices postoperatively', 'risk of PJI']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0410808', 'cui_str': 'Prosthetic joint infection'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1441.0,0.27038,"There was a significantly higher risk of PJI in patients treated by surgeons without fellowship training in arthroplasty (P = 0.01), surgeons with unknown fellowship training (P = 0.03), and surgeons with no fellowship training (P = 0.02) than those treated by an arthroplasty-trained surgeon.","[{'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'DeAngelis', 'Affiliation': 'aDepartment of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA; bDepartment of Surgery, University of Western Ontario, London, ON, Canada; cDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; and dDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Minutillo', 'Affiliation': ''}, {'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': ''}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': ''}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Donegan', 'Affiliation': ''}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001931']
2148,33034409,"Ratio between negative and positive lymph nodes is a novel prognostic indicator for patients with esophageal cancer: A Surveillance, Epidemiology and End Results database analysis.","BACKGROUND
The aim of this study was to explore whether the ratio between negative and positive lymph nodes (R NP ) could predict the overall survival (OS) of esophageal cancer (EC) patients with lymph node metastasis following esophagectomy.
METHODS
We utilized the Surveillance, Epidemiology and End Results (SEER) database to include the records of 2374 patients with lymph node metastases post-surgery. All patients were randomly assigned into the training cohort (n = 1424) and validation cohort (n = 950). Multivariate Cox regression analyses were performed to identify independent prognostic factors. A novel R NP -based TR NP M staging system was proposed. The prognostic value of N, R NP , TNM and TR NP M staging system was evaluated using the linear trend χ 2 test, likelihood ratio χ 2 test, and Akaike information criterion (AIC) to determine the potential superiorities. We constructed nomograms to predict survival in both cohorts, and the calibration curves confirmed the predictive ability.
RESULTS
Univariate analyses showed that N and R NP stage significantly influenced the OS of patients. Multivariate analyses revealed that R NP was an independent prognostic predictor in both the training and validation cohorts. For the stratification analysis in the two cohorts, we found significant differences in the prognosis of patients in different R NP groups on the basis of the different N stages and the number of dissected lymph nodes. In addition, the lower AIC value of R NP stage and TR NP M staging system represented superior predictive accuracy for OS than the N stage and TNM staging system, respectively. Furthermore, the calibration curves for the probability of three- and five-year survival showed good consistency between nomogram predictive abilities and actual observation.
CONCLUSIONS
We demonstrated that compared to the classical pathological lymph nodal staging system, the R NP stage showed superior predictive accuracy for OS and can serve as a more effective prognostic guidance for lymph node positive EC patients.",2020,"We demonstrated that compared to the classical pathological lymph nodal staging system, the R NP stage showed superior predictive accuracy for OS and can serve as a more effective prognostic guidance for lymph node positive EC patients.","['2374 patients with lymph node metastases post-surgery', 'patients with esophageal cancer', 'esophageal cancer (EC) patients with lymph node metastasis following esophagectomy']",[],"['overall survival (OS', 'prognostic value of N, R NP , TNM and TR NP M staging system']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",2374.0,0.0712769,"We demonstrated that compared to the classical pathological lymph nodal staging system, the R NP stage showed superior predictive accuracy for OS and can serve as a more effective prognostic guidance for lymph node positive EC patients.","[{'ForeName': 'Wanyi', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Huagang', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Hongdian', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Jia', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Yueyang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Immunology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Tang', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}, {'ForeName': 'Zhentao', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': ""Department of Esophageal Cancer, Key Laboratory of Cancer Prevention and Therapy of Tianjin, Tianjin's Clinical Research Center for Cancer, National Clinical Research Center of Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.""}]",Thoracic cancer,['10.1111/1759-7714.13688']
2149,33031860,Believing is achieving - On the role of treatment expectation in neurofeedback applications.,"In neurofeedback applications, neural activity is recorded, processed in real-time and fed back to the user in order to facilitate self-regulation of the putative neural mechanisms that underlie cognition and behavior. Numerous studies suggest that neurofeedback interventions are an efficacious treatment particularly for patients with attention-deficit/hyperactivity disorder (ADHD). In recent years, however, findings of several well-controlled studies raised doubts concerning the proposed mechanism of action behind the behavioral effect of neurofeedback. This study investigated the impact of expectation on the efficacy of a sensorimotor rhythm (SMR) training. In a within-subjects design 30 blinded volunteers with ADHD symptoms received a standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations regarding the effectiveness of neurofeedback (by telling them that they would train a specific frequency band that was previously shown to be either unrelated to attention, should improve attention, or interfere with attentional processes). After each training, participants were presented with a cognitive test and subsequently requested to rate their performance on it. We could show that participants were able to successfully modify their EEG signal during training. Further, we found an effect over trainings on objective attentional performance. Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence. This study presents strong first evidence for a substantial effect of self-confirming response expectancies as one factor underlying the efficacy of neurofeedback. Future research has to carefully consider the impact of such psychosocial mechanisms when evaluating the (specific) efficacy of neuromodulatory treatments.",2020,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.",['patients with attention-deficit/hyperactivity disorder (ADHD'],"['standard SMR training session after inducing no (no-expectancy condition), positive (placebo condition), and negative (nocebo condition) expectations', 'sensorimotor rhythm (SMR) training', 'neurofeedback interventions']",['objective attentional performance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C2713543', 'cui_str': 'Electroencephalographic biofeedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0296425,"Most importantly, we found that the expectancy of positive or negative treatment effects considerably changed participants' perception of neurofeedback's efficacy even in the absence of any objective evidence.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schönenberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany. Electronic address: michael.schoenenberg@uni-tuebingen.de.'}, {'ForeName': 'Anna-Lena', 'Initials': 'AL', 'LastName': 'Weingärtner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weimer', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Ulm University Medical Center, Germany.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scheeff', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Germany.'}]",Progress in neuro-psychopharmacology & biological psychiatry,['10.1016/j.pnpbp.2020.110129']
2150,33038677,Rethink Vape: Development and evaluation of a risk communication campaign to prevent youth E-cigarette use.,"INTRODUCTION
E-cigarettes are now the most common form of tobacco use among adolescents, and use is associated with increased risk of initiation of cigarette smoking. This project used a community-engaged research process to develop and pilot a risk communication campaign to prevent youth vaping.
METHOD
The research team worked with a 36-member Teen Advisory Council and a 19-member Expert Panel. Together, the team employed survey (N = 674) and focus group (N = 82) methodologies, and hired a marketing company to partner on development of the campaign. Campaign concepts were developed, eliminated, and/or modified through an iterative process of feedback and refinement. The final campaign included video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape). The campaign communicated three messages to teens: what's in the vapor, health risks, and connections to big tobacco. Prior to launch of the campaign, a randomized controlled 2 (time) × 2 (group) online experiment was conducted to evaluate the campaign (N = 268).
RESULTS
Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change. Following evaluation, the team launched a 6-week online media campaign with a teen-targeted geo-fence radius to deliver 3,838,465 impressions, 770,443 completed video views, and 18,316 clicks in mobile app, Snapchat, YouTube, and Spotify platforms. The majority of placements exceeded industry standards, with mobile pre-roll and Snapchat as top performers.
CONCLUSIONS
The e-cigarette campaign showed promising signs of effectiveness and scalability.",2020,"RESULTS
Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.",[],['Rethink Vape'],"['vaping knowledge, perceptions of risk, and anti-vape intentions', 'video ads (https://bit.ly/2QMR8gH) a microsite (rethinkvape.org), and social media sites (@rethinkvape']",[],"[{'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]","[{'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",770443.0,0.0316952,"RESULTS
Repeated measures mixed analyses of variance indicated that vaping knowledge, perceptions of risk, and anti-vape intentions significantly increased among teens viewing the Rethink Vape Materials compared to their own baseline, while control participants did not change.","[{'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'England', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States. Electronic address: englankj@evms.edu.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Edwards', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Paulson', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Libby', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Harrell', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Mondejar', 'Affiliation': 'Pediatrics Division of Community Health and Research, Eastern Virginia Medical School, PO Box 1980, Norfolk, VA 23501, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106664']
2151,33238936,Can counter-advertising diminish persuasive effects of conventional and pseudo-healthy unhealthy food product advertising on parents?: an experimental study.,"BACKGROUND
To help address rising rates of obesity in children, evidence is needed concerning impacts of common forms of marketing for unhealthy child-oriented food products and the efficacy of educational interventions in counteracting any detrimental impacts of such marketing. This study aims to explore parents' responses to advertising for unhealthy children's food products that employ different types of persuasive appeals and test whether a counter-advertising intervention exposing industry motives and marketing strategies can bolster parents' resistance to influence by unhealthy product advertising.
METHODS
N = 1613 Australian parents were randomly assigned to view online either a: (A) non-food ad (control); (B) conventional confectionery ad (highlighting sensory benefits of the product); (C) pseudo-healthy confectionery ad (promoting sensory benefits and health attributes of the product); (D) conventional confectionery ad + counter-ad (employing inoculation-style messaging and narrative communication elements); (E) pseudo-healthy confectionery ad + counter-ad. Parents then viewed various snacks, including those promoted in the food ads and counter-ad. Parents nominated their preferred product, then rated the products.
RESULTS
Exposure to the conventional confectionery ad increased parents' preference for the advertised product, enhanced perceptions of the product's healthiness and reduced sugar content and boosted brand attitude. Exposure to the pseudo-healthy confectionery ad increased parents' preference for the advertised product, and enhanced perceptions of healthiness, fibre content and lower sugar content. The counter-ad diminished, but did not eliminate, product ad effects on parents' purchasing preference, product perceptions and brand attitudes. The counter-ad also prompted parents to perceive processed foods as less healthy, higher in sugar and lower in fibre and may have increased support for advertising regulation.
CONCLUSIONS
Exposure to unhealthy product advertising promoted favourable perceptions of products and increased preferences for advertised products among parents. Counter-advertising interventions may bolster parents' resistance to persuasion by unhealthy product advertising and empower parents to more accurately evaluate advertised food products.",2020,"The counter-ad diminished, but did not eliminate, product ad effects on parents' purchasing preference, product perceptions and brand attitudes.","['N\u2009', '1613 Australian parents']",['view online either a: (A) non-food ad (control); (B) conventional confectionery ad (highlighting sensory benefits of the product); (C) pseudo-healthy confectionery ad (promoting sensory benefits and health attributes of the product); (D) conventional confectionery ad + counter-ad (employing inoculation-style messaging and narrative communication elements); (E) pseudo-healthy confectionery ad + counter-ad'],"[""parents' preference"", 'sugar content and boosted brand attitude', ""parents' purchasing preference, product perceptions and brand attitudes""]","[{'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0359213,"The counter-ad diminished, but did not eliminate, product ad effects on parents' purchasing preference, product perceptions and brand attitudes.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dixon', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, 615 St Kilda Road, Melbourne, Victoria, 3004, Australia. Helen.Dixon@cancervic.org.au.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Scully', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, 615 St Kilda Road, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Gascoyne', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, 615 St Kilda Road, Melbourne, Victoria, 3004, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Wakefield', 'Affiliation': 'Centre for Behavioural Research in Cancer, Cancer Council Victoria, 615 St Kilda Road, Melbourne, Victoria, 3004, Australia.'}]",BMC public health,['10.1186/s12889-020-09881-1']
2152,33027166,What Factors Increase Revision Surgery Risk When Treating Displaced Femoral Neck Fractures With Arthroplasty: A Secondary Analysis of the HEALTH Trial.,"OBJECTIVES
HEALTH was a randomized controlled trial comparing total hip arthroplasty with hemiarthroplasty in low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome. No significant short-term differences between treatment arms were observed. The primary objective of this secondary HEALTH trial analysis was to determine if any patient and surgical factors were associated with increased risk of revision surgery within 24 months after hip fracture.
METHODS
We analyzed 9 potential factors chosen a priori that could be associated with revision surgery. The factors included age, body mass index, major comorbidities, independent ambulation, type of surgical approach, length of operation, use of femoral cement, femoral head size, and degree of femoral stem offset. Our statistical analysis was a multivariable Cox regression using reoperation within 24 months of index surgery as the dependent variable.
RESULTS
Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months. None of the studied factors were found to be predictors of revision surgery (P > 0.05).
CONCLUSION
Both total and partial hip replacements are successful procedures in low-energy displaced femoral neck fracture patients. We were unable to identify any patient or surgeon-controlled factors that significantly increased the need for revision surgery in our elderly and predominately female patient population. One should not generalize our findings to an active physiologically younger femoral neck fracture population.
LEVEL OF EVIDENCE
Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS
Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months.","['low-energy displaced femoral neck fracture patients aged ≥50 years with unplanned revision surgery within 24 months of the initial procedure being the primary outcome', 'low-energy displaced femoral neck fracture patients', 'our elderly and predominately female patient population', 'Displaced Femoral Neck Fractures With Arthroplasty']",['total hip arthroplasty with hemiarthroplasty'],"['risk of revision surgery', 'Revision Surgery Risk']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",1441.0,0.255039,"RESULTS
Of the 1441 patients included in this analysis, 8.1% (117/1441) experienced reoperation within 24 months.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blankstein', 'Affiliation': 'aDepartment of Orthopaedics and Rehabilitation, University of Vermont Medical Center, South Burlington, VT; bDepartment of Surgery, University of Western Ontario, London, ON, Canada; cDivision of Orthopaedic Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; dDepartment of Orthopedic and Trauma Surgery, OLVG, Amsterdam and Leiden University Medical Center, Leiden, the Netherlands; eDivision of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway; and fDepartment of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bzovsky', 'Affiliation': ''}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': ''}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Frihagen', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Axelrod', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': ''}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': ''}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': ''}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Schottel', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001936']
2153,33028101,"PAR1 (Protease-Activated Receptor 1) Pepducin Therapy Targeting Myocardial Necrosis in Coronary Artery Disease and Acute Coronary Syndrome Patients Undergoing Cardiac Catheterization: A Randomized, Placebo-Controlled, Phase 2 Study.","OBJECTIVE
Arterial thrombosis leading to ischemic injury worsens the prognosis of many patients with cardiovascular disease. PZ-128 is a first-in-class pepducin that reversibly inhibits PAR1 (protease-activated receptor 1) on platelets and other vascular cells by targeting the intracellular surface of the receptor. The TRIP-PCI (Thrombin Receptor Inhibitory Pepducin in Percutaneous Coronary Intervention) trial was conducted to assess the safety and efficacy of PZ-128 in patients undergoing cardiac catheterization with intent to perform percutaneous coronary intervention. Approach and Results: In this randomized, double-blind, placebo-controlled, phase 2 trial, 100 patients were randomly assigned (2:1) to receive PZ-128 (0.3 or 0.5 mg/kg), or placebo in a 2-hour infusion initiated just before the start of cardiac catheterization, on top of standard oral antiplatelet therapy. Rates of the primary end point of bleeding were not different between the combined PZ-128 doses (1.6%, 1/62) and placebo group (0%, 0/35). The secondary end points of major adverse coronary events at 30 and 90 days did not significantly differ but were numerically lower in the PZ-128 groups (0% and 2% in the PZ-128 groups, 6% and 6% with placebo, p=0.13, p=0.29, respectively). In the subgroup of patients with elevated baseline cardiac troponin I, the exploratory end point of 30-day major adverse coronary events + myocardial injury showed 83% events in the placebo group versus 31% events in the combined PZ-128 drug groups, an adjusted relative risk of 0.14 (95% CI, 0.02-0.75); P =0.02.
CONCLUSIONS
In this first-in-patient experience, PZ-128 added to standard antiplatelet therapy appeared to be safe, well tolerated, and potentially reduced periprocedural myonecrosis, thus providing the basis for further clinical trials. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02561000.",2020,"The secondary end points of major adverse coronary events at 30 and 90 days did not significantly differ but were numerically lower in the PZ-128 groups (0% and 2% in the PZ-128 groups, 6% and 6% with placebo, p=0.13, p=0.29, respectively).","['Undergoing Cardiac Catheterization', 'Coronary Artery Disease and Acute Coronary Syndrome Patients', 'patients with elevated baseline cardiac troponin', 'patients undergoing cardiac catheterization with intent to perform percutaneous coronary intervention', '100 patients', 'patients with cardiovascular disease']","['PZ-128', 'placebo', 'Placebo', 'PAR1 (Protease-Activated Receptor 1) Pepducin Therapy']","['major adverse coronary events', 'safety and efficacy', '30-day major adverse coronary events + myocardial injury', 'bleeding']","[{'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0668084', 'cui_str': 'PAR-1 Receptor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",100.0,0.515208,"The secondary end points of major adverse coronary events at 30 and 90 days did not significantly differ but were numerically lower in the PZ-128 groups (0% and 2% in the PZ-128 groups, 6% and 6% with placebo, p=0.13, p=0.29, respectively).","[{'ForeName': 'Athan', 'Initials': 'A', 'LastName': 'Kuliopulos', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Gurbel', 'Affiliation': 'Inova Center for Thrombosis Research and Translational Medicine, Inova Fairfax Hospital, Falls Church, VA and Sinai Hospital of Baltimore, MD (P.A.G., K.P.B.).'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Rade', 'Affiliation': 'Division of Cardiology, Department of Medicine, University of Massachusetts Memorial Medical Center, University of Massachusetts Medical School, Worcester (J.J.R).'}, {'ForeName': 'Carey D', 'Initials': 'CD', 'LastName': 'Kimmelstiel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Tufts Medical Center, Boston, MA (C.D.K.).'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Turner', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Bliden', 'Affiliation': 'Inova Center for Thrombosis Research and Translational Medicine, Inova Fairfax Hospital, Falls Church, VA and Sinai Hospital of Baltimore, MD (P.A.G., K.P.B.).'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Fletcher', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Cox', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Covic', 'Affiliation': 'Center for Hemostasis and Thrombosis Research, Tufts Medical Center, Tufts University School of Medicine, Boston, MA (A.K., S.E.T., E.K.F., D.H.C., L.C.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.315168']
2154,33032908,Alpha-lipoic acid improves sperm motility in infertile men after varicocelectomy: a triple-blind randomized controlled trial.,"RESEARCH QUESTION
Does supplementation with alpha-lipoic acid (ALA) enhance sperm parameters and/or the status of sperm lipid peroxidation and DNA fragmentation in men who have undergone microsurgical repair of a varicocele?
DESIGN
Individuals with a varicocele who had undergone varicocelectomy were divided into two groups receiving either 600 mg of ALA or an identical placebo for 80 days. Semen samples obtained from the participants before surgery and after completion of the course of medication were analysed and compared. Participants, clinicians and data analysts were blinded to the randomization sequence.
RESULTS
In the ALA group, total motility (P = 0.01) and progressive motility (P = 0.002) of the spermatozoa were significantly higher compared with the placebo group after surgery. Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
CONCLUSIONS
An 80-day course of ALA medication after surgical repair improves total motility and progressive motility of the spermatozoa in individuals with a varicocele.",2020,"Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
","['individuals with a varicocele', 'Individuals with a varicocele who had undergone varicocelectomy', 'men who have undergone microsurgical repair of a varicocele', 'infertile men after varicocelectomy']","['placebo', 'alpha-lipoic acid (ALA', '600\xa0mg of ALA or an identical placebo', 'Alpha-lipoic acid']","['total motility and progressive motility', 'progressive motility', 'Sperm lipid peroxidation and DNA damage', 'sperm motility', 'total motility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042341', 'cui_str': 'Varicocele'}, {'cui': 'C0194985', 'cui_str': 'Excision of varicocele'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0567345', 'cui_str': 'Microsurgical repair'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0023775', 'cui_str': 'Lipid peroxidation'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}]",,0.50103,"Sperm lipid peroxidation and DNA damage (assessed by sperm chromatin structure assay) showed significant decreases in both the ALA and placebo groups (P ≤ 0.02) after treatment.
","[{'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Abbasi', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran; Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Newsha', 'Initials': 'N', 'LastName': 'Molavi', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Marziyeh', 'Initials': 'M', 'LastName': 'Tavalaee', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Homayoun', 'Initials': 'H', 'LastName': 'Abbasi', 'Affiliation': 'Isfahan Fertility and Infertility Center, Isfahan, Iran.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran; Isfahan Fertility and Infertility Center, Isfahan, Iran. Electronic address: mh.nasr-esfahani@royaninstitute.org.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.08.013']
2155,33030868,Association of a Pediatric Gynecology eLearning Module With Resident Knowledge and Clinical Skills: A Randomized Controlled Trial.,"OBJECTIVE
To assess whether a pediatric and adolescent gynecology electronic learning (eLearning) module improves knowledge and clinical performance among obstetrics and gynecology residents.
METHODS
We conducted a multi-institutional, single-blinded, randomized controlled trial across four university programs; three had pediatric and adolescent gynecology rotations, and two had pediatric and adolescent gynecology fellowship-trained faculty. Applying permutated block randomization, residents were randomized to no intervention or completion of a validated eLearning module on prepubertal bleeding. All residents subsequently completed a pediatric and adolescent gynecology-related knowledge assessment that queried understanding of prepubertal bleeding and an objective structured clinical examination that assessed history collection, performance of a prepubertal genital examination, vaginal culture, and vaginoscopy for a pediatric patient. Objective structured clinical examinations were videotaped and reviewed by two faculty, blinded to randomization group; interrater reliability score was 97%. We calculated descriptive frequencies and compared randomization groups using χ analyses and Fisher exact tests for categorical variables, and median tests for continuous variables; a value of P<.05 was considered significant.
RESULTS
From July 2018 to June 2019, we invited 115 residents to participate; 97 (83%) completed both objective structured clinical examination and follow-up knowledge assessments. Most were female (91%) and the majority reported limited pediatric and adolescent gynecology didactic or clinical experience, with 36% reporting prior didactics on prepubertal vaginal bleeding and 33% reporting prior exposure to the prepubertal genital examination. Forty-five participants (46%) were randomized to the module and groups were similar across training levels. Residents assigned to the module scored significantly higher on the knowledge assessment (4/5 vs 2/5, P<.001) and objective structured clinical examination (13/16 vs 7/16, P<.001) and were more likely to avoid a speculum in the examination of a pediatric patient (95.6% vs 57.7%, P<.001).
CONCLUSION
Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents. Applying this learning technique in other programs may help address deficiencies in pediatric and adolescent gynecology education and training.",2020,Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents.,"['Pediatric Gynecology eLearning Module With Resident Knowledge and Clinical Skills', 'All residents subsequently completed a pediatric and adolescent gynecology-related knowledge assessment that queried understanding of prepubertal bleeding', 'From July 2018 to June 2019, we invited 115 residents to participate; 97 (83%) completed both objective structured clinical examination and follow-up knowledge assessments', 'four university programs; three had pediatric and adolescent gynecology rotations, and two had pediatric and adolescent gynecology fellowship-trained faculty', 'Forty-five participants (46', 'obstetrics and gynecology residents']","['no intervention or completion of a validated eLearning module', 'pediatric and adolescent gynecology electronic learning (eLearning) module']","['knowledge assessment', 'prepubertal vaginal bleeding', 'knowledge and clinical performance', 'objective structured clinical examination', 'interrater reliability score']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015770', 'cui_str': 'Fellowships'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.111094,Our pediatric and adolescent gynecology eLearning module resulted in improved short-term resident knowledge and simulated clinical skills among obstetrics and gynecology residents.,"[{'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Huguelet', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Colorado School of Medicine, and the Division of Pediatric and Adolescent Gynecology, Children's Hospital Colorado, Aurora, Colorado; Pediatric and Adolescent Gynecology, University of Louisville, Norton Healthcare, Louisville, Kentucky; the Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, Rhode Island; the Division of General Obstetrics and Gynecology, Department of Obstetrics, Gynecology and Newborn Care, the Ottawa Hospital, the Division of Gynecology, Department of Surgery, Children's Hospital of Eastern Ontario, and the Department of Obstetrics and Gynecology, University of Ottawa, Ottawa, Ontario, Canada; the Department of Obstetrics and Gynecology, Virginia Commonwealth University School of Medicine, Richmond, Virginia; and the Division of Family Planning, Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Abraham', 'Affiliation': ''}, {'ForeName': 'Veronica I', 'Initials': 'VI', 'LastName': 'Alaniz', 'Affiliation': ''}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Dolinko', 'Affiliation': ''}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Dumont', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Karjane', 'Affiliation': ''}, {'ForeName': 'Janina V', 'Initials': 'JV', 'LastName': 'Pearce', 'Affiliation': ''}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Ruder', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Wheeler', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Guiahi', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004098']
2156,33030881,Foley Bulb Added to an Oral Misoprostol Induction Protocol: A Cluster Randomized Trial.,"OBJECTIVE
To evaluate whether the induction of labor in term gravid women with cervical dilation 2 cm or less and intact membranes by using oral misoprostol preceded by transcervical Foley bulb placement results in a significantly increased vaginal delivery rate compared with the use of oral misoprostol alone.
METHODS
We randomized the induction method by week of admission to labor and delivery, with each week group described as a cluster in a block randomized design. Women with gestational age of 37 weeks or greater, cervical dilation 2 cm or less, intact membranes, and indication for labor induction were included. Study arms were either 100 micrograms of oral misoprostol after transcervical Foley bulb placement or 100 micrograms of oral misoprostol alone. The primary outcome was vaginal delivery with the first induction attempt. Secondary outcomes included time to delivery, clinical chorioamnionitis (maternal temperature of 38°C or greater during labor with or without fundal tenderness, without other identified cause), cesarean delivery indication, and adverse outcomes. We estimated that a sample size of 1,077 per arm was needed to detect a 5% increase in vaginal delivery rate with a type I error of 5% and power of 80%, accounting for interim analysis and cluster size of 30 inductions per week. This was a pragmatic trial, and analysis was by intention-to-treat.
RESULTS
From January 1, 2018, to May 13, 2019, 1,117 women (34 clusters) were assigned to oral misoprostol plus Foley and 1,110 women (34 clusters) to oral misoprostol alone. Demographic characteristics were similar. Vaginal delivery at the first induction occurred in 78% of the misoprostol plus Foley arm and in 77% of the misoprostol arm (relative risk [RR] 1.00; 95% CI 0.96-1.05; adjusted relative risk [aRR], 1.00; 95% CI 0.95-1.05). Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56). There were no differences in neonatal outcomes.
CONCLUSION
Induction of labor in gravid women at term with intact membranes by using oral misoprostol plus Foley bulb did not result in a higher vaginal delivery rate, but it did result in more clinical chorioamnionitis compared with the use of oral misoprostol alone.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03407625.",2020,Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56).,"['gravid women at term with intact membranes', 'From January 1, 2018, to May 13, 2019, 1,117 women (34 clusters', 'term gravid women with cervical dilation 2 cm or less and intact membranes', 'Women with gestational age of 37 weeks or greater, cervical dilation 2 cm or less, intact membranes, and indication for labor induction were included']","['misoprostol', 'oral misoprostol', 'oral misoprostol plus Foley', 'oral misoprostol alone', 'misoprostol alone']","['neonatal outcomes', 'Vaginal delivery', 'Clinical chorioamnionitis', 'vaginal delivery with the first induction attempt', 'vaginal delivery rate', 'time to delivery, clinical chorioamnionitis (maternal temperature of 38°C or greater during labor with or without fundal tenderness, without other identified cause), cesarean delivery indication, and adverse outcomes']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]",,0.370732,Clinical chorioamnionitis occurred in 18% of the misoprostol plus Foley arm and in 14% of the misoprostol arm (RR 1.30; 95% CI 1.07-1.58; aRR 1.30; 95% CI 1.08-1.56).,"[{'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Adhikari', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'McIntire', 'Affiliation': ''}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Leveno', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004123']
2157,33036921,A single center randomized double blind controlled trial of pentoxifylline in acute pancreatitis: Challenges and opportunities.,"OBJECTIVES
Despite substantial morbidity and mortality associated with acute pancreatitis (AP), only one small randomized controlled drug trial (RCT) is available in the past few decades from the United States. Hence, we conducted a single-center, double-blind, placebo-controlled RCT of pentoxifylline in AP.
METHODS
A total of 9 doses of oral pentoxifylline 400 mg or placebo tablet, three times daily, was administered within 72 h of diagnosis, using randomization blocks by pharmacy. Primary outcome was a composite outcome including any of the following: death, peripancreatic and/or pancreatic necrosis, infected pancreatic necrosis, persistent organ failure, persistent systemic inflammatory response syndrome, hospital stay longer than 4 days, need for intensive care, and need for intervention for necrosis.
RESULTS
Between July 7, 2015, and April 4, 2017, we identified 685 patients with AP, 233 met eligibility criteria and 176 were approached for the study. Of these, 91 (51.7%) declined and finally 45 in pentoxifylline group and 38 in placebo group (83 total) were compared. There were no significant differences in primary outcome (27 [60.0%] vs 15 [39.5%]; P = .06). Pentoxifylline group was not associated with any benefit, but withlonger stay (42% vs. 21%; P = .04) and higher readmission rates (16 %vs 3%; P = .047).
CONCLUSIONS
We could not demonstrate superiority of pentoxifylline over placebo. Smaller sample size and inclusion of all types of severity might be the reasons for lack of efficacy. The challenges observed in the present study indicate that, in order to conduct a successful drug trial in AP, a multi center collaboration is essential.",2020,"Pentoxifylline group was not associated with any benefit, but withlonger stay (42% vs. 21%; P = .04) and higher readmission rates (16 %vs 3%; P = .047).
","['acute pancreatitis', '685 patients with AP, 233 met eligibility criteria and 176 were approached for the study']","['placebo', 'oral pentoxifylline 400\xa0mg or placebo', 'placebo-controlled RCT of pentoxifylline', 'Pentoxifylline', 'pentoxifylline']","['higher readmission rates', 'withlonger stay', 'composite outcome including any of the following: death, peripancreatic and/or pancreatic necrosis, infected pancreatic necrosis, persistent organ failure, persistent systemic inflammatory response syndrome, hospital stay longer than 4 days, need for intensive care, and need for intervention for necrosis']","[{'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0988533', 'cui_str': 'Pentoxifylline 400 MG'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013168', 'cui_str': 'Drug Control'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442162', 'cui_str': 'Peripancreatic'}, {'cui': 'C0267941', 'cui_str': 'Acute necrotizing pancreatitis'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}]",,0.64374,"Pentoxifylline group was not associated with any benefit, but withlonger stay (42% vs. 21%; P = .04) and higher readmission rates (16 %vs 3%; P = .047).
","[{'ForeName': 'Santhi Swaroop', 'Initials': 'SS', 'LastName': 'Vege', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA. Electronic address: vege.santhi@mayo.edu.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Horibe', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Suresh T', 'Initials': 'ST', 'LastName': 'Chari', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Magdalen A', 'Initials': 'MA', 'LastName': 'Clemens', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Conor G', 'Initials': 'CG', 'LastName': 'Loftus', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Felicity T', 'Initials': 'FT', 'LastName': 'Enders', 'Affiliation': 'Division of Gastroenterology and Hepatology (Drs Vege, Horibe, Chari [emeritus Member], and Loftus and Ms Clemens) and Division of Biomedical Statistics and Informatics (Dr Enders), Mayo Clinic, Rochester, MN, USA.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.09.023']
2158,33035763,Effect of oral health intervention on cognitive decline in community-dwelling older adults: A randomized controlled trial.,"PURPOSE
The incidence of dementia is rapidly increasing worldwide, especially in developed countries. Little is known regarding the effectiveness of dental intervention to prevent dementia or a decline in cognitive functions among community-dwelling older adults, but a few studies have reported a correlation between the lack of regular dental checkups and dementia. For that reason, this study aimed to investigate the effects of oral health intervention on cognitive functions in community-dwelling subjects with a mild cognitive decline via a randomized controlled trial.
PATIENTS AND METHODS
Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year were randomized to an intervention group (n = 28) or a control group (n = 29). The intervention group received monthly oral health intervention by dental hygienists for 8 months while the control group did not. Data on demographics, cognitive function and oral parameters were collected before and after the intervention.
RESULTS
Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study. Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05). There were also significant interactions between the TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability (P < 0.05).
CONCLUSION
Oral health intervention by dental hygienists may be effective for improving the oral health and executive function of cognitive function assessed via TMT.",2021,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","['Twenty-five subjects in the intervention group (mean age 77.0 years) and 25 in the control group (mean age 72.8 years) completed the study', 'community-dwelling subjects with a mild cognitive decline via a randomized controlled trial', 'community-dwelling older adults', 'Fifty-five community-dwelling older adults with a Mini-Mental State Examination score of ≥21 to ≤26 who had not visited a dental clinic in the previous year']","['oral health intervention', 'monthly oral health intervention']","['cognitive decline', 'Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability', 'cognitive functions', 'demographics, cognitive function and oral parameters', 'TMT-A and TMT-B scores, oral diadochokinesis, tongue pressure and chewing ability']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0278157', 'cui_str': 'Diadochokinesia'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",55.0,0.0438053,"Significant improvements were observed in the Trail Making Test (TMT)-A, TMT-B, bleeding on probing rate, oral diadochokinesis, tongue pressure and chewing ability in the intervention group (P < 0.05).","[{'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Matsubara', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: m.chiakingyo@gmail.com.'}, {'ForeName': 'Maki', 'Initials': 'M', 'LastName': 'Shirobe', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan; Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: mashirobe@gmail.com.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Furuya', 'Affiliation': 'Department of Geriatric Dentistry, Showa University School of Dentistry, 2-1-1 Kitasenzoku, Ohta-ku, Tokyo 145-8515, Japan. Electronic address: furuyajunichi@gmail.com.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Watanabe', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan; Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University, Nishi-7, Kita-13, Kita-ku, Sapporo, 060-8586, Japan. Electronic address: ywata@den.hokudai.ac.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Motokawa', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kikiki_1004@yahoo.co.jp.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Edahiro', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: aedahiro514@gmail.com.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Ohara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: yohara@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Awata', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: awata@tmig.or.jp.'}, {'ForeName': 'Hunkyung', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: kimhk@tmig.or.jp.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: fujiwayo@tmig.or.jp.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Obuchi', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: obuchipc@tmig.or.jp.'}, {'ForeName': 'Hirohiko', 'Initials': 'H', 'LastName': 'Hirano', 'Affiliation': 'Tokyo Metropolitan Institute of Gerontology, 35-2 Sakae-cho, Itabashi-ku, Tokyo 173-0015, Japan. Electronic address: h-hiro@gd5.so-net.ne.jp.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Minakuchi', 'Affiliation': 'Gerodontology and Oral Rehabilitation, Department of Gerontology and Gerodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8549, Japan. Electronic address: s.minakuchi.gerd@tmd.ac.jp.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104267']
2159,33027722,Hysteroscopic versus cervical injection for sentinel node detection in endometrial cancer: A multicenter prospective randomised controlled trial from the Multicenter Italian Trials in Ovarian cancer (MITO) study group.,"AIM
During the last years, the role of sentinel lymph node mapping (SLNM) for endometrial cancer (EC) surgical treatment has increased in popularity. However, several controversies remain about different technical steps of SLNM. Thus, a randomised control trial was designed to compare cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection for SLNM of newly diagnosed EC undergoing surgical staging. The primary end-point of the study was to compare these two techniques in terms of para-aortic detection rate.
METHODS
Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study. This randomised trial distinguished patients in two study groups according to two different techniques of ICG SLNM: CI versus HI injection. Patients who met the inclusion criteria were randomly assigned to CI or HI injection in a 1:1 ratio. The central randomisation system allocated patient randomisation numbers sequentially in the order in which the patients were enrolled. This randomised trial was not blinded for either patients or the surgeons.
RESULTS
From March 2017 until April 2019, a total of 165 patients were randomised in this study: 85 (51.5%) in the CI group and 80 (48.5%) in the HI group. After randomisation, 14 (8.5%) patients were excluded from the study. Finally, 151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group. Hysteroscopy injection shows an ability to detect Sentinel nodes (SNLs) in the para-aortic area of about 10% greater compared with CI injection, although this difference did not reach statistical significance. The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%). The CI injection was correlated with higher SLN detection rates at the pelvic level compared with HI injection. Pelvic and overall detection was higher in the CI group.
CONCLUSIONS
The present study supports the adoption of CI instead of HI injection because the former allows better identification of sentinel nodes (especially in the pelvic area). Detection of SLN in the para-aortic area was slightly higher in patients receiving a HI injection, but the difference with the CI route was not statistically significant.",2020,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"['151 patients were included in the analysis: 82 (54.3%) in the CI group and 69 (45.7%) in the HI group', '165 patients', 'Patients who met the inclusion criteria', 'patients or the surgeons', 'From March 2017 until April 2019', 'Patients with apparent stage I or II histologically confirmed EC undergoing surgery were included in the study', 'endometrial cancer', 'newly diagnosed EC undergoing surgical staging']","['cervical (CI) and hysteroscopic (HI) indocyanine green (ICG) injection', 'sentinel lymph node mapping (SLNM', 'Hysteroscopic versus cervical injection', 'ICG\xa0SLNM: CI versus HI injection', 'CI or HI injection', 'Hysteroscopy injection']","['para-aortic detection rate', 'SLN detection rates', 'Pelvic and overall detection']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443276', 'cui_str': 'Pathological staging'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1519247', 'cui_str': 'Sentinel lymph node mapping'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]","[{'cui': 'C0442134', 'cui_str': 'Para-aortic'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",165.0,0.181524,The HI technique was superior in detecting isolated para-aortic SLNs (5.8% Versus 0%).,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Ditto', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy. Electronic address: antonino.ditto@istitutotumori.mi.it.'}, {'ForeName': 'Jvan', 'Initials': 'J', 'LastName': 'Casarin', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Pinelli', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Perrone', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Bogani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Leone Roberti Maggiore', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Signorelli', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiappa', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Giorda', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS CRO Oncologic Institute of Aviano, Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Scibilia', 'Affiliation': 'Unit of Obstetrics and Gynaecology, Cannizzaro Hospital of Catania, Italy.'}, {'ForeName': 'Pierandrea', 'Initials': 'P', 'LastName': 'De Iaco', 'Affiliation': ""Unit Gynaecologic Oncology, Sant'Orsola Malpighi of Bologna, Bologna, Italy.""}, {'ForeName': 'Mariateresa', 'Initials': 'M', 'LastName': 'Evangelista', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ghezzi', 'Affiliation': 'Academic Unit of Obstetrics and Gynaecology, Insubria University of Varese, Varese, Italy.'}, {'ForeName': 'Biagio', 'Initials': 'B', 'LastName': 'Paolini', 'Affiliation': 'Department of Pathology, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy; Unit of Clinical Epidemiology and Trial Organization, IRCCS National Cancer Institute, Milan, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Montone', 'Affiliation': 'Clinical Study Coordinator, Ufficio Operativo per la Ricerca Clinica - Clinical Trial Center Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Department of Gynecologic Oncology, IRCCS National Cancer Institute, Milan, Italy.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.08.030']
2160,33032123,"The effect of emergency manuals on team performance during two different simulated perioperative crises: A prospective, randomized controlled trial.","STUDY OBJECTIVE
Whether having an emergency manual (EM) available for use during perioperative crises enhances or detracts from team performance, especially for multi-factorial diagnostic situations that do not explicitly match a chapter of the EM.
DESIGN
A simulation-based, prospective randomized trial based upon two perioperative crises, one involving a patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter.
SETTING
52 regularly scheduled 6-h courses at the Center for Medical Simulation in Boston, Massachusetts, USA.
STUDY GROUP
304 US-trained practicing anesthesiologists.
INTERVENTIONS
The absence or presence of the EM during the simulation case.
MEASUREMENTS
Teams were rated in the following categories: primary underlying diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage. Also, raters recorded free-text 'field notes' about the usage-patterns and perceived utility of the EM. Using these 'field notes' and a two-stage, inductively revised procedure, two independent reviewers examined a subset of case videos for action analysis.
MAIN RESULTS
Performance ratings for a total of 51 teams and 95 simulations were included in the final analysis. No effect on performance was demonstrated with providing the EM in either the refractory hypotension/septic shock case or the transfusion reaction case, with the exception of the PEA arrest category. In the subset of simulations in which resuscitation from PEA arrest performance could be evaluated, EM availability was associated with an adjusted mean 1.3 point (99% confidence interval [CI]: 0.2, 2.4) improvement in performance in the transfusion reaction case (p = 0.004), but only an adjusted mean 0.2 point (99% CI, -0.7, 1.1) improvement in the refractory hypotension/septic shock case (p = 0.530) (p for interaction = 0.069). Analysis of actions found that when available, the EM was usually used, but often not until after cardiac arrest had occurred. In some cases, teams persisted with incorrect diagnoses and treatments irrespective of the presence or absence of an EM.
CONCLUSIONS
Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist. A suggestion of improved cardiac arrest resuscitation with the availability of an EM was found, but should be interpreted with caution given a limited sample size. Observed actions using the EM demonstrated that only about half of the teams used the EM to any substantive degree and most used it relatively late in the crisis. By observation, the EM appeared to be helpful in about half of the cases and did not, by itself, deter from appropriate management.",2020,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","['patient with a transfusion reaction for which the EM contains a specific chapter, and the other involving a patient with refractory hypotension progressing into septic shock for which the EM does not have a specific chapter', 'two different simulated perioperative crises', '52']",[],"['diagnosis, fluid resuscitation, treatment of primary diagnosis, cardiac arrest management, overall crisis management, and (if applicable) EM usage', 'refractory hypotension/septic shock case', 'EM availability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0274435', 'cui_str': 'Blood transfusion reaction'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}]",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231224', 'cui_str': 'Crisis'}, {'cui': 'C1272460', 'cui_str': 'Not applicable'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C4304283', 'cui_str': 'Refractory hypotension'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",52.0,0.125845,"Providing an EM did not affect team performance in areas like diagnosis, treatment, fluid resuscitation, communication, and teamwork in management of perioperative crises such as transfusion reaction where an explicit chapter in the EM exists and refractory hypotension / septic shock where an explicit chapter does not exist.","[{'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Urman', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America; Center for Perioperative Research, Brigham and Women's Hospitals, Boston, MA, United States of America. Electronic address: rurman@bwh.harvard.edu.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'August', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Jiddou', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'J Bradley', 'Initials': 'JB', 'LastName': 'Morrison', 'Affiliation': 'Brandeis International Business School, Waltham, MA, United States of America.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Palaganas', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raemer', 'Affiliation': 'Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, United States of America.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110080']
2161,33032164,"Exploring the impact of a liquefied petroleum gas intervention on time use in rural Peru: A mixed methods study on perceptions, use, and implications of time savings.","BACKGROUND
Efforts to promote clean cooking through adoption of clean-burning fuels such as liquefied petroleum gas (LPG) are often based on the idea that near-exclusive use of LPG could lead to health improvements. However, benefits beyond health, such as time savings, could be more tangible and meaningful to LPG users.
OBJECTIVES
This study investigated the effect of an LPG intervention on time spent cooking and collecting fuel, using objective measures of stove temperatures combined with self-reports under conditions of near-exclusive LPG use. We also investigated the perceived value of any time savings and potential economic and quality of life implications.
METHODS
We analyzed data from the Cardiopulmonary outcomes and Household Air Pollution trial in Puno, Peru, a randomized controlled trial with 180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention. Surveys conducted with 90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed time spent cooking and collecting biomass fuel and use of time savings. Cooking time was objectively measured with temperature sensors on all stoves. Qualitative interviews explored perceptions and use of time savings in more depth.
RESULTS
Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day. Participants perceived time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields.
DISCUSSION
This paper suggests that the benefits of LPG extend beyond health and the environment. LPG use could also lead to economic and quality of life gains, through increased time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection.",2020,"RESULTS
Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","['180 participants assessing exposure and health impacts of an LPG stove, fuel, and behavioral intervention', '90 intervention women receiving free LPG and 90 control women cooking primarily with biomass assessed', 'rural Peru']","['LPG', 'liquefied petroleum gas intervention', 'LPG intervention']","['time for work, rest, and consumption of hot meals, and reduced arduous biomass fuel collection', 'time spent cooking and collecting biomass fuel and use of time savings', 'time saved from LPG positively, reporting more time for household chores, leisure activities, and activities with income-generating potential such as caring for animals and working in fields', 'Cooking time', 'time savings and potential economic and quality of life implications']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0336754', 'cui_str': 'Stove'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0303763', 'cui_str': 'Liquefied petroleum gas'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",180.0,0.0503954,"RESULTS
Intervention women spent 3.2 fewer hours cooking and 1.9 fewer hours collecting fuel per week compared to control women, but cooked on average 1.0 more meals per day.","[{'ForeName': 'Kendra N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA. Electronic address: kendra.williams@jhu.edu.'}, {'ForeName': 'Josiah L', 'Initials': 'JL', 'LastName': 'Kephart', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Fandiño-Del-Rio', 'Affiliation': 'Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA; Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Simkovich', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Koehler', 'Affiliation': 'Department of Environmental Health and Engineering, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Harvey', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Checkley', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA; Center for Global Non-Communicable Disease Research and Training, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Environment international,['10.1016/j.envint.2020.105932']
2162,33032168,COPDCompEx: A novel composite endpoint for COPD exacerbations to enable faster clinical development.,"BACKGROUND
Frequency of moderate and severe chronic obstructive pulmonary disease exacerbations is an important endpoint in clinical trials, but makes them large and lengthy when powered to evaluate it. We aimed to develop a composite endpoint (COPDCompEx) that could predict treatment effect on exacerbations, enabling the design of shorter early phase clinical trials requiring fewer patients.
METHODS
In this post hoc analysis, data from 20 randomized controlled trials were used to develop and test COPDCompEx. Diary events were tested against predefined threshold values for peak expiratory flow, reliever medication use, and symptoms. A COPDCompEx event was defined as first occurrence of a diary event, a moderate or severe exacerbation, or a study dropout. Ratios of event frequency, treatment effect and future trial sample size were compared between COPDCompEx and moderate and severe exacerbations.
FINDINGS
At 3 months, the proportion of patients experiencing COPDCompEx events increased over 3-fold versus exacerbations alone. All components contributed to COPDCompEx event rate. Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
INTERPRETATION
COPDCompEx may be used to predict treatment effect on moderate and severe exacerbations of chronic obstructive pulmonary disease. This may enable the design of shorter Phase 2 clinical trials requiring fewer patients when compared with current exacerbation studies, with exacerbations as a key Phase 3 endpoint. This would, therefore, allow more efficient decision-making with reduced burden and risk to study participants.",2020,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
",['moderate and severe chronic obstructive pulmonary disease exacerbations'],['COPDCompEx'],"['peak expiratory flow, reliever medication use, and symptoms', 'proportion of patients experiencing COPDCompEx events']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.362478,"Treatment effects at 3 months were closely matched between COPDCompEx and exacerbations, and the large net gain in power substantially reduced the required sample size.
","[{'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Marburg, Germany, Member of the German Center for Lung Research (DZL).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fuhlbrigge', 'Affiliation': 'Pulmonary Sciences and Critical Care, Department of Medicine, University of Colorado School of Medicine, Denver, CO, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Jauhiainen', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Lieke E J M', 'Initials': 'LEJM', 'LastName': 'Scheepers', 'Affiliation': 'AstraZeneca, BioPharma Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, Gothenburg, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bengtsson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Peterson', 'Affiliation': 'StatMind Statistical and Mathematical Modelling, Innovation and Design AB, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Karlsson', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Sethi', 'Affiliation': 'Emeritus Professor Respiratory Medicine, Kings College, London, UK; Galecto Biotech, London, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Locantore', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Tal-Singer', 'Affiliation': 'GlaxoSmithKline R&D, Medical Innovation Value Evidence and Outcomes, Collegeville, PA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rennard', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Cambridge, UK.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Fagerås', 'Affiliation': 'AstraZeneca, BioPharmaceuticals Medical, Gothenburg, Sweden.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Da Silva', 'Affiliation': 'AstraZeneca, Early Respiratory & Immunology (R&I) Clinical Development, BioPharmaceuticals R&D, Gothenburg, Sweden. Electronic address: Carla.DaSilva@astrazeneca.com.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106175']
2163,33035067,Tantrum Tool: Development and Open Pilot Study of Online Parent Training for Irritability and Disruptive Behavior.,"Objectives: Parent management training is an effective treatment for disruptive behavior disorders but it is often underutilized in clinical settings. Access to care is limited due to logistical barriers as well as limited service availability. This study examines in an open trial the acceptability, feasibility, and clinical effects of a digital parent management training intervention that includes videoconference coaching, called ""Tantrum Tool."" Methods: Fifteen children, ages 3-9 years, participated in an open trial of an 8-week intervention. The primary symptom measure was the Disruptive Behavior Rating Scale (DBRS), and the secondary outcome measure was the Affective Reactivity Index (ARI) completed by the primary caregiver before and after treatment. Results: Treatment retention was high (80%), and parents reported a high level of satisfaction with the program. There was a significant reduction in the mean DBRS score from 13.5 ± 5.5 at baseline to 7.3 ± 3.4 at endpoint, p < 0.001. There was also a significant reduction in the mean ARI irritability score from 7.2 ± 2.6 at baseline to 3.75 ± 2.1 at endpoint, p < 0.01. Conclusions: This open pilot study supports the feasibility and acceptability of a digital parent training program for young children with disruptive behavior. Findings provide preliminary support for a clinically meaningful reduction of both disruptive behavior and irritability. Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children. ClinicalTrials.gov: NCT03697837.",2020,Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children.,"['young children', 'Fifteen children, ages 3-9 years, participated in an open trial of an 8-week intervention', 'young children with disruptive behavior']","['Parent management training', 'Online Parent Training', 'digital parent management training intervention', 'digital parent training program']","['mean DBRS score', 'Affective Reactivity Index (ARI', 'Disruptive Behavior Rating Scale (DBRS', 'mean ARI irritability score', 'Treatment retention']","[{'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",15.0,0.023215,Using the Tantrum Tool to deliver online treatment for children could increase access to first-line treatments for disruptive behavior and irritability in young children.,"[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Diaz-Stransky', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Rowley', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Zecher', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grodberg', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Sukhodolsky', 'Affiliation': 'Yale Child Study Center, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0089']
2164,33038432,Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis.,"BACKGROUND & AIMS
Non-alcoholic steatohepatitis is a leading cause of end-stage liver disease. Hepatic steatosis and lipotoxicity cause chronic necroinflammation and direct hepatocellular injury resulting in cirrhosis, end-stage liver disease and hepatocellular carcinoma. Emricasan is a pan-caspase inhibitor that inhibits excessive apoptosis and inflammation; it has also been shown to decrease portal pressure and improve synthetic function in mice with carbon tetrachloride-induced cirrhosis.
METHODS
This double-blind, placebo-controlled study randomized 217 individuals with decompensated NASH cirrhosis 1:1:1 to emricasan (5 mg or 25 mg) or placebo. Patients were stratified by decompensation status and baseline model for end-stage liver disease-sodium (MELD-Na) score. The primary endpoint comprised all-cause mortality, a new decompensation event (new or recurrent variceal hemorrhage, new ascites requiring diuretics, new unprecipitated hepatic encephalopathy ≥grade 2, hepatorenal syndrome, spontaneous bacterial peritonitis), or an increase in MELD-Na score ≥4 points.
RESULTS
There was no difference in event rates between either of the emricasan treatment groups and placebo, with hazard ratios of 1.02 (95% CI 0.59-1.77; p = 0.94) and 1.28 (95% CI 0.75-2.21; p = 0.37) for 5 mg and 25 mg of emricasan, respectively. MELD-Na score progression was the most common outcome. There was no significant effect of emricasan treatment on MELD-Na score, international normalized ratio, total serum bilirubin, albumin level or Child-Pugh score. Emricasan was generally safe and well-tolerated.
CONCLUSIONS
Emricasan was safe but ineffective for the treatment of decompensated NASH cirrhosis. However, this study may guide the design and conduct of future clinical trials in decompensated NASH cirrhosis.
LAY SUMMARY
Patients with decompensated cirrhosis related to non-alcoholic steatohepatitis are at high risk of additional decompensation events and death. Post hoc analyses in previous pilot studies suggested that emricasan might improve portal hypertension and liver function. In this larger randomized study, emricasan did not decrease the number of decompensation events or improve liver function in patients with a history of decompensated cirrhosis related to non-alcoholic steatohepatitis. CLINICALTRIALS.
GOV IDENTIFIER
NCT03205345.",2020,"There was no significant effect of emricasan treatment on MELD-Na score, INR, total serum bilirubin albumin level or Child-Turcotte-Pugh score.","['217 subjects with decompensated NASH cirrhosis 1:1:1 to emricasan (5 or 25 mg) or', 'decompensated NASH cirrhosis', 'mice with CCl 4 -induced cirrhosis', 'patients with NASH-related decompensated cirrhosis']","['MELD', 'placebo']","['MELD-Na score, INR, total serum bilirubin albumin level or Child-Turcotte-Pugh score', 'new decompensation events, improving liver function or mortality', 'event rates', 'safe and well-tolerated', 'Na score progression', 'synthetic function', 'new decompensation event (new or recurrent variceal hemorrhage, new ascites requiring diuretics, new unprecipitated hepatic encephalopathy ≥ grade 2, hepatorenal syndrome, spontaneous bacterial peritonitis']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0007537', 'cui_str': 'Cefaclor'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C3854424', 'cui_str': 'Child-Pugh-Turcotte score'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0333106', 'cui_str': 'Bleeding varices'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0019151', 'cui_str': 'Hepatic encephalopathy'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0019212', 'cui_str': 'Hepatorenal syndrome'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",217.0,0.509743,"There was no significant effect of emricasan treatment on MELD-Na score, INR, total serum bilirubin albumin level or Child-Turcotte-Pugh score.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Frenette', 'Affiliation': 'Department of Organ Transplant, Scripps Clinic, La Jolla, CA.'}, {'ForeName': 'Zeid', 'Initials': 'Z', 'LastName': 'Kayali', 'Affiliation': 'Inland Empire Liver Foundation, Rialto, CA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mena', 'Affiliation': 'California Liver Research Institute, Pasadena, CA.'}, {'ForeName': 'Parvez S', 'Initials': 'PS', 'LastName': 'Mantry', 'Affiliation': 'Methodist Health System Clinical Research Institute, Dallas, TX.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Lucas', 'Affiliation': 'Diabetes & Endocrinology Consultants, PC, Moorhead City, NC.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Neff', 'Affiliation': 'Covenant Research, Lakewood Ranch, FL.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'IMIC Inc, Palmetto Bay, FL.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Thuluvath', 'Affiliation': 'Mercy Medical Center, Baltimore, MD.'}, {'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Weinberg', 'Affiliation': 'University of Pennsylvania Medical Center, Philadelphia, PA.'}, {'ForeName': 'Bal R', 'Initials': 'BR', 'LastName': 'Bhandari', 'Affiliation': 'Delta Research Partners, Bastrop, LA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Conatus Pharmaceuticals, Inc., San Diego, CA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wedick', 'Affiliation': 'SimulStat, Inc., Solana Beach, CA.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Chan', 'Affiliation': 'Conatus Pharmaceuticals, Inc., San Diego, CA.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Hagerty', 'Affiliation': 'Conatus Pharmaceuticals, Inc., San Diego, CA.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Institute Northwest, Seattle, WA. Electronic address: kkowdley@liverinstitutenw.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hepatology,['10.1016/j.jhep.2020.09.029']
2165,33041145,Comparison of ibuprofen and piroxicam gel in the treatment of trauma pain: A randomized double-blind trial of geriatric population.,"OBJECTIVE
This study aimed to compare the analgesic efficacy of topical ibuprofen and topical piroxicam for acute musculoskeletal injuries.
METHODS
In this prospective, randomized, controlled, double-blinded study, geriatric patients were assigned to groups to receive either topical ibuprofen (n = 70) or topical piroxicam (n = 69). The first dose of gel was applied in the emergency department and the remaining doses were self-administered at home by the patients thrice daily for 72 h. For each patient, the initial baseline visual analog scale (VAS) score (V 0) was compared with the VAS scores at the 60 min (V1), 120 min (V2), 24 h (V3) and 72 h (V4) time points. The decreases in VAS scores, clinical effectiveness of the treatments, and incidence of adverse events were evaluated.
RESULTS
In the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001). The results were as follows: V0 -V: 1.08, 95% CI: 0.56-1.61; V0 -V2: 1.09, 95% CI: 0.49-1.69; V0 -V3: 1.44, 95% CI: 0.81-2.07; V0 -V4: 1.59, 95% CI: 0.91-2.26. The mean percentage decrease in the VAS scores in the topical ibuprofen group was significantly higher than that in the topical piroxicam group (p < .001). The clinical effect of treatment was found to be significantly higher for the ibuprofen gel group (p < .001). There was no substantial difference in treatment-related adverse events between the groups (p > .05).
CONCLUSION
Ibuprofen gel, which is a safe treatment option for geriatric patients, is more clinically effective than piroxicam gel. Response to Reviewers.",2020,"In the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001).","['geriatric population', 'geriatric patients', 'trauma pain']","['ibuprofen and piroxicam gel', 'Ibuprofen gel', 'topical ibuprofen', 'piroxicam gel', 'topical piroxicam', 'topical ibuprofen and topical piroxicam']","['VAS scores', 'adverse events', 'initial baseline visual analog scale (VAS) score', 'VAS scores, clinical effectiveness of the treatments, and incidence of adverse events', 'analgesic efficacy']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0031990', 'cui_str': 'Piroxicam'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0360483', 'cui_str': 'Ibuprofen-containing product in cutaneous dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.108007,"In the topical ibuprofen group, the VAS scores were significantly lower at each measurement time point compared to baseline (p < .001).","[{'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey. Electronic address: akbasilker@gmail.com.'}, {'ForeName': 'Tugba Sanalp', 'Initials': 'TS', 'LastName': 'Menekse', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Thoracic Surgery, Manisa City Hospital, Manisa, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.08.041']
2166,33044203,Effects of insole on the less affected side during execution of treadmill walking training on gait ability in chronic stroke patients: A preliminary study.,"BACKGROUND
People who have had hemiplegic stoke generally move more weight to the unaffected side than the affected side, resulting in asymmetrical posture and decreased ability in walking.
OBJECTIVES
This study sought to investigate the effect of inducing a weight shift to the affected side by raising the shoe height of the less affected side using an insole during the execution of treadmill training on gait ability in people with chronic stroke.
METHODS
The subjects were randomly assigned into two groups: insole on less affected side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW) group. The treadmill training was conducted for 30 minutes per session, 5 times a week, for 4 weeks. A gait analyzer based on body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6 MWT), was measured before first intervention and after twentieth treadmill training intervention (Trial registration number is KCT0003830).
RESULTS
The results revealed statistically significant differences between the two groups in the Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT of the gait test. In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
CONCLUSIONS
ILTW, more than NTW, may improve walking ability in people with chronic stroke as it increases the weight-support ratio by adjusting the shoe height of the unaffected side using an insole.",2020,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","['chronic stroke patients', 'People who have had hemiplegic stoke', 'people with chronic stroke']","['side for execution of treadmill walking training (ILTW) group and normal treadmill training (NTW', 'treadmill walking training', 'treadmill training']","['Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT after execution of training', 'weight-support ratio', 'body center, Functional Gait Assessment (FGA), Figure-of-Eight Walk Test (F8WT), and 6 min Walk Test (6\u200aMWT', 'Speed, Cadence, FGA, F8WT, and 6\u200aMWT', 'gait ability', 'walking ability', 'Speed, Cadence, Stride Length/Height, Stride Length, Double Support Duration, Single Support Duration, FGA, F8WT, and 6\u200aMWT of the gait test']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.0322436,"In the ILTW group, statistically significant improvements were observed in the Speed, Stride Length/Height, Stride Length, Stance Phase Duration, Swing Phase Duration, Double Support Duration, Single Support Duration, FGA, F8WT, and 6 MWT after execution of training, while in the NTW group, statistically significant improvements were observed only in Speed, Cadence, FGA, F8WT, and 6 MWT.
","[{'ForeName': 'Bora', 'Initials': 'B', 'LastName': 'An', 'Affiliation': 'Department of Physical Therapy, Raon Hue Hospital, Sinwol-ro, Yangcheon-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Youngkeun', 'Initials': 'Y', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Kyuenam', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}, {'ForeName': 'Sujin', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Medical Sciences, Jeonju University, Cheonjam-ro, Wansan-gu, Jeonju, Republic of Korea.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201040']
2167,33044283,Effect of Driving Pressure Change During Extracorporeal Membrane Oxygenation in Adults With Acute Respiratory Distress Syndrome: A Randomized Crossover Physiologic Study.,"OBJECTIVES
Venovenous extracorporeal membrane oxygenation is an effective intervention to improve gas exchange in patients with severe acute respiratory distress syndrome. However, the mortality of patients with severe acute respiratory distress syndrome supported with venovenous extracorporeal membrane oxygenation remains high, and this may be due in part to a lack of standardized mechanical ventilation strategies aimed at further minimizing ventilator-induced lung injury. We tested whether a continuous positive airway pressure ventilation strategy mitigates ventilator-induced lung injury in patients with severe acute respiratory distress syndrome on venovenous extracorporeal membrane oxygenation, compared with current ventilation practice that employs tidal ventilation with limited driving pressure. We used plasma biomarkers as a surrogate outcome for ventilator-induced lung injury.
DESIGN
Randomized crossover physiologic study.
SETTING
Single-center ICU.
PATIENTS
Ten patients with severe acute respiratory distress syndrome supported on venovenous extracorporeal membrane oxygenation.
INTERVENTIONS
The study included four phases. After receiving pressure-controlled ventilation with driving pressure of 10 cm H2O for 1 hour (phase 1), patients were randomly assigned to receive first either pressure-controlled ventilation 20 cm H2O for 2 hours (phase 2) or continuous positive airway pressure for 2 hours (phase 3), and then crossover to the other phase for 2 hours; during phase 4 ventilation settings returned to baseline (pressure-controlled ventilation 10 cm H2O) for 4 hours.
MEASUREMENTS AND MAIN RESULTS
There was a linear relationship between the change in driving pressure and the plasma concentration of interleukin-6, soluble receptor for advanced glycation end products, interleukin-1ra, tumor necrosis factor alpha, surfactant protein D, and interleukin-10.
CONCLUSIONS
Ventilator-induced lung injury may occur in acute respiratory distress syndrome patients on venovenous extracorporeal membrane oxygenation despite the delivery of volume- and pressure-limited mechanical ventilation. Reducing driving pressure to zero may provide more protective mechanical ventilation in acute respiratory distress syndrome patients supported with venovenous extracorporeal membrane oxygenation. However, the risks versus benefits of such an approach need to be confirmed in studies that are designed to test patient centered outcomes.",2020,Reducing driving pressure to zero may provide more protective mechanical ventilation in acute respiratory distress syndrome patients supported with venovenous extracorporeal membrane oxygenation.,"['Adults With Acute Respiratory Distress Syndrome', 'Ten patients with severe acute respiratory distress syndrome', 'acute respiratory distress syndrome patients', 'patients with severe acute respiratory distress syndrome']","['Venovenous extracorporeal membrane oxygenation', 'continuous positive airway pressure ventilation strategy mitigates ventilator-induced lung injury', 'venovenous extracorporeal membrane oxygenation', 'Extracorporeal Membrane Oxygenation', 'current ventilation practice that employs tidal ventilation with limited driving pressure', 'Driving Pressure Change', 'pressure-controlled ventilation 20 cm H2O for 2 hours (phase 2) or continuous positive airway pressure']","['driving pressure and the plasma concentration of interleukin-6, soluble receptor for advanced glycation end products, interleukin-1ra, tumor necrosis factor alpha, surfactant protein D, and interleukin-10']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C2350350', 'cui_str': 'Lung Injury, Ventilator-Induced'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0563547', 'cui_str': 'Pressure change'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0101725', 'cui_str': 'Receptor for Advanced Glycation Endproducts'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",10.0,0.145177,Reducing driving pressure to zero may provide more protective mechanical ventilation in acute respiratory distress syndrome patients supported with venovenous extracorporeal membrane oxygenation.,"[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Del Sorbo', 'Affiliation': '1Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, ON, Canada. 2Latner Thoracic Surgery Research Laboratories, University Health Network, University of Toronto, Toronto, ON, Canada. 3Extracorporeal Life Support Program, Toronto General Hospital, University of Toronto, Toronto, ON, Canada. 4Department of Medicine, Division of Respirology, University Health Network and Sinai Health System, Toronto, ON, Canada. 5Institute for Health Policy, Management, and Evaluation, University of Toronto, Toronto, ON, Canada. 6Department of Medicine, University Health Network and Sinai Health System, Toronto, ON, Canada. 7Division of Thoracic Surgery, Department of Surgery, University Health Network, University of Toronto, Toronto, ON, Canada. 8Keenan Research Center at the Li-Ka-Shing Knowledge Institute of St. Michael´s Hospital, Toronto, ON, Canada. 9Toronto General Hospital Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Goffi', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': ''}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Pettenuzzo', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Facchin', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vendramin', 'Affiliation': ''}, {'ForeName': 'Ewan C', 'Initials': 'EC', 'LastName': 'Goligher', 'Affiliation': ''}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': ''}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ''}, {'ForeName': 'Shaf', 'Initials': 'S', 'LastName': 'Keshavjee', 'Affiliation': ''}, {'ForeName': 'Niall D', 'Initials': 'ND', 'LastName': 'Ferguson', 'Affiliation': ''}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004637']
2168,33044684,Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product.,"INTRODUCTION
ABP 798 is being developed as a biosimilar to rituximab reference product (RP), a CD20-directed cytolytic antibody that is approved in the US and EU for the treatment of non-Hodgkin lymphoma (NHL).
METHODS
This randomized, double-blind, comparative clinical study (JASMINE) evaluated the efficacy and safety of ABP 798 compared with rituximab RP. Adult, anti-CD20 treatment naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20 were randomized 1:1 to receive a 375 mg/m 2 infusion of either ABP 798 or rituximab RP once weekly for 4 weeks and at weeks 12 and 20. Tumor assessments were performed at baseline and weeks 12 and 28. Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
RESULTS
Of the 256 randomized patients, 254 were treated with ABP 798 (n = 128; 100%) or rituximab RP (n = 126; 98.4%); 96 (78.0%) patients in the ABP 798 group and 87 (70.2%) in the rituximab RP group had a best ORR by week 28. The point estimate of RD in ORR between ABP 798 and rituximab RP from the adjusted generalized linear model for stratification factors was 7.7%. Clinical equivalence was based on sequential testing of the one-sided 95% lower confidence limits and one-sided 95% upper confidence limits of RD in ORR (- 1.4% and 16.8%, respectively) which was within the prespecified non-inferiority margin (- 15%) and non-superiority margin (35.5%), respectively. Results of sensitivity analyses were consistent with the primary efficacy analysis. ABP 798 was also comparable to rituximab RP across additional secondary endpoints, further supporting the conclusion of similarity, and including: RD of ORR at week 12; trough serum concentrations; percent of patients with complete depletion of CD19+ cell count at day 8; safety; and immunogenicity.
CONCLUSIONS
These results support a conclusion of similar clinical efficacy between ABP 798 and rituximab RP in patients with follicular lymphoma.
NCT NUMBER
NCT02747043; first posted April 21, 2016.
EUDRACT NUMBER
2013-005,542-11; submitted 14 October, 2014.",2020,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","['naïve patients diagnosed with grade 1, 2, or 3a follicular B-cell NHL expressing CD20', '256 randomized patients', 'patients with follicular lymphoma', 'Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product']","['ABP', 'ABP 798 or rituximab RP', 'rituximab RP', 'anti-CD20 treatment']","['efficacy and safety', 'Efficacy and Safety', 'risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1868944', 'cui_str': ""Follicular B-cell non-Hodgkin's lymphoma""}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0001239', 'cui_str': 'Actin-binding protein'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",256.0,0.112772,"Primary endpoint was the risk difference (RD) of overall response rate (ORR) of complete response, unconfirmed complete response, or partial response by week 28 based on data from central, independent, and blinded assessments of disease.
","[{'ForeName': 'Dietger', 'Initials': 'D', 'LastName': 'Niederwieser', 'Affiliation': 'Division of Hematology and Oncology, University of Leipzig, Liebigstr. 19, 04106, Leipzig, Germany. Dietger.Niederwieser@medizin.uni-leipzig.de.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Schulich School of Medicine, Western University, Windsor, ON, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cobb', 'Affiliation': 'St. Vincent Frontier Cancer Center, Billings, MT, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Cecily', 'Initials': 'C', 'LastName': 'Forsyth', 'Affiliation': 'Gosford Hospital, Gosford, NSW, Australia.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Tucci', 'Affiliation': 'Hematology Department, ASST-Spedali Civili-Brescia, Brescia, Italy.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Hanes', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Delwail', 'Affiliation': 'Oncology-Hematology and Cell Therapy, Centre Hospitalier Universitaire de Poitiers, Poitiers, France.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hajek', 'Affiliation': 'Department of Hematooncology, Faculty of Medicine, University Hospital Ostrava, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chien', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Targeted oncology,['10.1007/s11523-020-00748-4']
2169,33039853,Effectiveness of expiratory flow acceleration in patients with Parkinson's disease and swallowing deficiency: A preliminary study.,"OBJECTIVES
Parkinson's disease (PD) causes dysfunction both to swallowing and to the cough mechanism. Oropharyngeal dysphagia is the main cause of pneumonia, due to silent aspiration of food and saliva. Pneumonia is the leading cause of death in PD. Different strategies exist to reduce the risk of inhalation and associated lung infections, but evidence of their efficacy is still unclear. The aim of this preliminary study was to investigate if adding an expiratory flow acceleration (EFA®) technique to standard therapy (ST) for dysphagia can reduce the incidence of bronchopulmonary infections and improve quality of life, respiratory function parameters, cough, and airways encumbrance perception.
MATERIALS AND METHODS
Twenty-five patients with PD were randomized to two groups: ST vs. ST + EFA. Patients were re-assessed at 30, 180 and 360 days from start of treatment. The primary outcome was the incidence of respiratory exacerbations together with quality of life score (PDQ-39). Secondary outcomes were changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS).
RESULTS
Twenty patients concluded the study (10 each group). Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group. Furthermore, there was a significant difference in cough effectiveness measured with the peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS).
CONCLUSION
The results of this preliminary study support the use of EFA® technology in Parkinson's patients with dysphagia to reduce the risk of respiratory complications. Nevertheless, further studies are needed in a larger, more representative sample to definitively confirm the usefulness of this technique in PD patients.",2020,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[""Parkinson's patients with dysphagia"", 'Twenty-five patients with PD', 'Twenty patients concluded the study (10 each group', ""patients with Parkinson's disease and swallowing deficiency""]","['expiratory flow acceleration (EFA®) technique to standard therapy (ST', 'EFA® technology', 'expiratory flow acceleration', 'ST vs. ST\u202f+\u202fEFA']","['cough effectiveness', 'changes in respiratory function tests, cough capacity (CPEF), perceived health status (Euro-QOL-VAS), cough, and upper airways encumbrance perception evaluated by visual numeric scale (VNS', 'peak cough expiratory flow (PCEF) and other spirometry parameters (FEV 1 , FVC), and also in specific and generic health-related quality of life measures (PDQ-39, Euro-QoL-VAS', 'respiratory infections, symptoms, hospital admissions and medical visits', 'incidence of respiratory exacerbations together with quality of life score (PDQ-39', 'quality of life, respiratory function parameters, cough, and airways encumbrance perception']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0917903', 'cui_str': 'Conclude Composite Resin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1533125', 'cui_str': 'Euro'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]",25.0,0.0541415,"Albeit the difference was not significant, less respiratory infections, symptoms, hospital admissions and medical visits were found in the study group.","[{'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Riboldazzi', 'Affiliation': ""Parkinson's Disease Unit, Gaetano and Piera Borghi Foundation, Brebbia, Italy.""}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Spinazza', 'Affiliation': 'Neurology Rehabilitation Department, Hospital of Cuasso al Monte, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beccarelli', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Prato', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Grecchi', 'Affiliation': 'Physical Medicine and Rehabilitation Department, General Hospital, Sestri Levante, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': ""D'Abrosca"", 'Affiliation': 'Italian Association of Respiratory Physiotherapists (ARIR), Milan, Italy.'}, {'ForeName': 'Antonello', 'Initials': 'A', 'LastName': 'Nicolini', 'Affiliation': 'Pulmonary Rehabilitation Unit, General Hospital, Sestri Levante, Italy. Electronic address: antonellonicolini@gmail.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106249']
2170,33045627,Percutaneous pulsed radiofrequency treatment of dorsal root ganglion for treatment of lumbar facet syndrome.,"OBJECTIVES
Percutaneous radiofrequency denervation of the medial dorsal branch is often used for treatment of chronic low back pain originating from intervertebral facets, which is sometimes associated with a low success rate and a higher incidence of recurrence of pain. We theorized that implementing pulsed radiofrequency treatment to dorsal root ganglion would increase the probability of successful pain relief.
PATIENTS AND METHODS
150 patients diagnosed with CLBP of a confirmed facet origin were included in a prospective randomized controlled trial and were randomly divided into three equal groups, the first was submitted to percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment. Local injection of a mixture of local anesthetic and a steroid was given to the three groups. Cases were followed for a maximum of 3 years.
RESULTS
98 (65.3 %) patients were females. By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63). At 2 years' follow-up, the pulsed radiofrequency treatment of the dorsal root ganglia group maintained significant improvement (p= 0.041) whereas the medial branch denervation group lost its significant effect (p=0.32).By the end of follow-up period, only pulsed radiofrequency treatment of the dorsal root ganglia group kept significant improvement (p=0.044).
CONCLUSION
In CLBP of facet origin, pulsed radiofrequency treatment of the dorsal root ganglia provides both a higher incidence as well as an extended period of pain relief compared to radiofrequency ablation of the medial dorsal branch of the facet joint.",2020,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","['lumbar facet syndrome', '98 (65.3 %) patients were females', '150 patients diagnosed with CLBP of a confirmed facet origin']","['percutaneous pulsed radiofrequency treatment of the dorsal root ganglia, the second underwent percutaneous radiofrequency denervation of the medial dorsal branch and the third was a control group that did not receive any radiofrequency treatment', 'Percutaneous pulsed radiofrequency treatment of dorsal root ganglion', 'mixture of local anesthetic and a steroid']","['VAS', 'probability of successful pain relief']","[{'cui': 'C0458225', 'cui_str': 'Lumbar facet joint pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1740811', 'cui_str': 'Radiofrequency denervation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",150.0,0.0175157,"By 3 months' post procedure, improvement in VAS was significantly better than pretreatment levels in all groups (p= 0.026); the pulsed radiofrequency treatment group, however, had significantly better incidence of improvement when compared to the other two groups (p= 0.014).The control group lost improvement by 1-year follow-up (p=0.63).","[{'ForeName': 'Wael Mohamed', 'Initials': 'WM', 'LastName': 'Moussa', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelmmosa@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khedr', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, Alexandria University, EL Khartoum Square, Azarita, Alexandria, Egypt. Electronic address: waelkhedr2000@yahoo.com.'}, {'ForeName': 'Medhat', 'Initials': 'M', 'LastName': 'Elsawy', 'Affiliation': 'Department of Neurosurgery, Faculty of Medicine, El Menia University, Korneesh El Nil, El Menia, Egypt. Electronic address: medhatelsawy73@yahoo.com.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106253']
2171,33048877,Financial incentives to increase pediatric HIV testing: a randomized trial.,"BACKGROUND
Financial incentives can motivate desirable health behaviors, including adult HIV testing. Data regarding the effectiveness of financial incentives for HIV testing in children, who require urgent testing to prevent mortality, are lacking.
METHODS
In a five-arm unblinded randomized controlled trial, adults living with HIV attending 19 HIV clinics in Western Kenya, with children 0-12 years of unknown HIV status, were randomized with equal allocation to $0, $1.25, $2.50, $5 or $10. Payment was conditional on child HIV testing within 2 months. Block randomization with fixed block sizes was used; participants and study staff were unblinded at randomization. Primary analysis was intent-to-treat, with predefined primary outcomes of completing child HIV testing and time to testing.
RESULTS
Of 452 caregivers, 90, 89, 93, 92 and 88 were randomized to $0, $1.25, $2.50, $5.00, and $10.00, respectively. Of those, 31 (34%), 31 (35%), 44 (47%), 51 (55%), and 54 (61%) in the $0, $1.25, $2.50, $5.00, and $10.00 arms, respectively, completed child testing. Compared with the $0 arm, and adjusted for site, caregivers in the $10.00 arm had significantly higher uptake of testing [relative risk: 1.80 (95% CI 1.15--2.80), P = 0.010]. Compared with the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms [hazard ratio: 1.95 (95% CI 1.24--3.07) P = 0.004, 2.42 (95% CI 1.55--3.79), P < 0.001, respectively).
CONCLUSION
Financial incentives are effective in improving pediatric HIV testing among caregivers living with HIV.
REGISTRATION
NCT03049917.",2021,"Compared to the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms (Hazard ratio: 1.95 [95%CI 1.24, 3.07]","['Of 452 caregivers, 90, 89, 93, 92 and 88', 'caregivers living with HIV', 'adults living with HIV attending 19 HIV clinics in Western Kenya, with children 0-12 years of unknown HIV status']",[],"['child HIV testing and time to testing', 'pediatric HIV testing']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]",,0.47975,"Compared to the $0 arm, and adjusted for site, time to testing was significantly faster in the $5.00 and $10.00 arms (Hazard ratio: 1.95 [95%CI 1.24, 3.07]","[{'ForeName': 'Irene N', 'Initials': 'IN', 'LastName': 'Njuguna', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Anjuli D', 'Initials': 'AD', 'LastName': 'Wagner', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Neary', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Vincent O', 'Initials': 'VO', 'LastName': 'Omondi', 'Affiliation': 'Kenya Pediatric Research Consortium, Kenya Pediatric Association, Nairobi, Kenya.'}, {'ForeName': 'Verlinda A', 'Initials': 'VA', 'LastName': 'Otieno', 'Affiliation': 'Kenya Pediatric Research Consortium, Kenya Pediatric Association, Nairobi, Kenya.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Orimba', 'Affiliation': 'Kenya Pediatric Research Consortium, Kenya Pediatric Association, Nairobi, Kenya.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Babigumira', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levin', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Global Health.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maleche-Obimbo', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Dalton C', 'Initials': 'DC', 'LastName': 'Wamalwa', 'Affiliation': 'Department of Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Epidemiology.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Slyker', 'Affiliation': 'Department of Epidemiology.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002720']
2172,33048879,Changes in weight and BMI with first-line doravirine-based therapy.,"OBJECTIVE
To evaluate changes in weight and BMI in adults with HIV-1 at 1 and 2 years after starting an antiretroviral regimen that included doravirine, ritonavir-boosted darunavir, or efavirenz.
DESIGN
Post-hoc analysis of pooled data from three randomized controlled trials.
METHODS
We evaluated weight change from baseline, weight gain at least 10%, and increase in BMI after 48 and 96 weeks of treatment with doravirine, ritonavir-boosted darunavir, or efavirenz-based regimens. Risk factors for weight gain and metabolic outcomes associated with weight gain were also examined.
RESULTS
Mean (and median) weight changes were similar for doravirine [1.7 (1.0) kg] and ritonavir-boosted darunavir [1.4 (0.6) kg] and were lower for efavirenz [0.6 (0.0) kg] at week 48 but were similar across all treatment groups at week 96 [2.4 (1.5), 1.8 (0.7), and 1.6 (1.0) kg, respectively]. No significant differences between treatment groups were found in the proportion of participants with at least 10% weight gain or the proportion with BMI class increase at either time point. Low CD4 T-cell count and high HIV-1 RNA at baseline were associated with at least 10% weight gain and BMI class increase at both timepoints, but treatment group, age, sex, and race were not.
CONCLUSION
Weight gains over 96 weeks were low in all treatment groups and were similar to the average yearly change in adults without HIV-1. Significant weight gain and BMI class increase were similar across the treatment groups and were predicted by low baseline CD4 T-cell count and high baseline HIV-1 RNA.",2021,Significant weight gain and BMI class increase were similar across the treatment groups and were predicted by low baseline CD4+ T-cell count and high baseline HIV-1 RNA.,['adults with HIV-1 at 1 and 2 years after starting an antiretroviral regimen that included'],"['doravirine-based therapy', 'doravirine, ritonavir-boosted darunavir, or efavirenz-based regimens', 'doravirine, ritonavir-boosted darunavir, or efavirenz', 'efavirenz']","['Mean [and median] weight changes', 'weight and body mass index', 'weight gain or the proportion with BMI class increase', 'body mass index (BMI', 'weight gain', 'Significant weight gain and BMI class increase', 'Weight gains', 'Low CD4+ T-cell count and high HIV-1 RNA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4045491', 'cui_str': 'DORAVIRINE'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}]",,0.0690866,Significant weight gain and BMI class increase were similar across the treatment groups and were predicted by low baseline CD4+ T-cell count and high baseline HIV-1 RNA.,"[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'HIV Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Elion', 'Affiliation': 'George Washington University School of Medicine, Washington, District of Columbia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, Georgia, USA.'}, {'ForeName': 'Juergen K', 'Initials': 'JK', 'LastName': 'Rockstroh', 'Affiliation': 'Medizinische Klinik und Poliklinik, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alvarez Bognar', 'Affiliation': 'Global Medical Affairs.'}, {'ForeName': 'Zhi J', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Hwang', 'Affiliation': 'Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sklar', 'Affiliation': 'Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Martin', 'Affiliation': 'Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002725']
2173,33048901,Effect of Nonsedation on Cognitive Function in Survivors of Critical Illness.,"OBJECTIVES
Critical illness can cause severe cognitive impairments. The objective of this trial was to assess the effect of nonsedation versus sedation with a daily wake-up call during mechanical ventilation on cognitive function in adult survivors of critical illness.
DESIGN
Single-center substudy of the multicenter, randomized Non-sedation Versus Sedation With a Daily Wake-up Trial in Critically Ill Patients Receiving Mechanical Ventilation trial. Three months after ICU-discharge participants were tested for cognitive function by a neuropsychologist.
SETTING
Mixed 14-bed ICU in teaching hospital.
PATIENTS
A total of 205 critically ill, orally intubated, and mechanically ventilated adults.
INTERVENTIONS
Patients were randomized within the first 24 hours from intubation to either nonsedation with sufficient analgesia or light sedation with a daily wake-up call during mechanical ventilation.
MEASUREMENTS AND MAIN RESULTS
A total of 118 patients survived to follow-up and 89 participated (75%). The participating survivors in the two groups did not differ regarding baseline data or premorbid cognitive impairments. Sedated patients had received more sedatives, whereas doses of morphine and antipsychotics were equal. The primary outcome was that no significant difference was found in the number of patients with mild/moderate cognitive impairments (six nonsedated patients vs four sedated patients) or severe cognitive impairments (16 nonsedated patients vs 17 sedated patients; p = 0.71). Secondary outcomes were cognitive test scores, and no differences were found between the scores in nonsedated and sedated patients. Hypothetical worst case scenarios where all patients, who had not participated in follow-up assessment, were assumed to have severe cognitive impairments were analyzed, but still no difference between the groups was found. We found more patients with delirium in the sedated group (96% vs 69% of patients; p = 0.002) and increased duration of delirium in sedated patients (median 5 vs 1 d; p < 0.001). Delirium subtypes were equally distributed between the groups, with hypoactive delirium most frequent (61%), followed by mixed delirium (39%).
CONCLUSIONS
Nonsedation did not affect cognitive function 3 months after ICU-discharge.",2020,"Secondary outcomes were cognitive test scores, and no differences were found between the scores in nonsedated and sedated patients.","['118 patients survived to follow-up and 89 participated (75', 'Survivors of Critical Illness', 'adult survivors of critical illness', 'Critically Ill Patients Receiving Mechanical Ventilation trial', '205 critically ill, orally intubated, and mechanically ventilated adults', 'Mixed 14-bed ICU in teaching hospital']","['sedation Versus Sedation', 'morphine and antipsychotics', 'nonsedation with sufficient analgesia or light sedation with a daily wake-up call during mechanical ventilation', 'nonsedation versus sedation with a daily wake-up call during mechanical ventilation']","['Delirium subtypes', 'delirium', 'severe cognitive impairments', 'Cognitive Function', 'cognitive test scores', 'cognitive function', 'duration of delirium', 'premorbid cognitive impairments', 'number of patients with mild/moderate cognitive impairments']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C3839816', 'cui_str': 'Moderate cognitive impairment'}]",205.0,0.186786,"Secondary outcomes were cognitive test scores, and no differences were found between the scores in nonsedated and sedated patients.","[{'ForeName': 'Helene Korvenius', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': '1Department of Anesthesiology and Intensive Care, Lillebaelt Hospital Kolding, University Hospital of Southern Denmark, Kolding, Denmark. 2Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 3Department of Regional Health Research, University of Southern Denmark, Odense, Denmark. 4Clinic of Neuropsychology, Odense, Denmark. 5Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark. 6Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Hanne Irene', 'Initials': 'HI', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Stylsvig', 'Affiliation': ''}, {'ForeName': 'Hanne Tanghus', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': ''}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Korkmaz', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': ''}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004573']
2174,31764094,Delayed gastrointestinal-associated lymphoid tissue reconstitution in duodenum compared with rectum in HIV-infected patients initiating antiretroviral therapy.,"BACKGROUND
We aimed to characterize the impact of antiretroviral therapy (ART) initiation on gastrointestinal-associated lymphoid tissue at various sites along the gastrointestinal site.
METHODOLOGY
Peripheral blood and duodenal and rectal biopsies were obtained from 12 HIV to 33 treatment-naive HIV participants at baseline and after 9 months ART. Tissue was digested for immunophenotyping. Inflammatory, bacterial translocation and intestinal damage markers were measured in plasma.
RESULTS
Twenty-six HIV patients completed follow-up. The lowest reconstitution of CD4 T cells and the lowest CD4/CD8 ratio during ART compared with blood were observed in the duodenum with the rectum being either intermediate or approaching blood levels. Regulatory T cells were in higher proportions in the duodenum than the rectum and neither declined significantly during ART. Several correlations with biomarkers of microbial translocation were observed including increases in lipoteichoic acid levels, which reflects Gram-positive bacterial translocation, correlated with increases in %CD4 T cells in the duodenum (Rho 0.773, P = 0.033), and with decreases in duodenal regulatory T-cell populations (Rho -0.40, P = 0.045).
CONCLUSION
HIV-mediated immunological disruption is greater in the duodenum than rectum and blood before and during ART. Small intestine damage may represent a unique environment for T-cell depletion, which might be attenuated by interaction with Gram-positive bacteria.",2019,Regulatory T cells were in higher proportions in the duodenum than the rectum and neither declined significantly during ART.,"['Peripheral blood and duodenal and rectal biopsies were obtained from 12 HIV to 33 treatment-naive HIV participants at baseline and after 9 months ART', 'Twenty-six HIV patients completed follow-up']",['antiretroviral therapy (ART) initiation'],"['Delayed gastrointestinal-associated lymphoid tissue reconstitution', 'CD4 T cells', 'lowest reconstitution of CD4 T cells and the lowest CD4/CD8 ratio', 'Regulatory T cells', 'duodenal regulatory T-cell populations', 'lipoteichoic acid levels', 'Inflammatory, bacterial translocation and intestinal damage markers']","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0193050', 'cui_str': 'Biopsy of rectum'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0024296', 'cui_str': 'Lymphatic tissue'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0065067', 'cui_str': 'lipoteichoic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282583', 'cui_str': 'Bacterial translocation'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",26.0,0.0917926,Regulatory T cells were in higher proportions in the duodenum than the rectum and neither declined significantly during ART.,"[{'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Sainz', 'Affiliation': 'aDepartment of Pediatrics, La Paz University Hospital and Research Institute (ldiPAZ), Madrid bDepartment of Infectious Diseases, Ramon y Cajal University Hospital and Research Institute (IRYCIS), Faculty of Medicine, University of Alcalá, Alcalá, Spain cUniversity of California Davis Medical Center, Sacramento dCalifornia National Primate Research Center, Davis, California eUniversity of Texas Medical Branch, Galveston, Texas fSchool of Pharmacy, University of North Carolina, Chapel Hill, North Carolina gLaboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, Bethesda, Maryland hRush University Medical Center, Chicago, Illinois iVeterans Administration Northern California Health Care System, Mather jUniversity of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Serrano-Villar', 'Affiliation': ''}, {'ForeName': 'Surinder', 'Initials': 'S', 'LastName': 'Mann', 'Affiliation': ''}, {'ForeName': 'Zhong-Min', 'Initials': 'ZM', 'LastName': 'Ma', 'Affiliation': ''}, {'ForeName': 'Netanya S', 'Initials': 'NS', 'LastName': 'Utay', 'Affiliation': ''}, {'ForeName': 'Corbin G', 'Initials': 'CG', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'Tae-Wook', 'Initials': 'TW', 'LastName': 'Chun', 'Affiliation': ''}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Kashuba', 'Affiliation': ''}, {'ForeName': 'Basile', 'Initials': 'B', 'LastName': 'Siewe', 'Affiliation': ''}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Albanese', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Troia-Cancio', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sinclair', 'Affiliation': ''}, {'ForeName': 'Anoma', 'Initials': 'A', 'LastName': 'Somasunderam', 'Affiliation': ''}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Yotter', 'Affiliation': ''}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Moreno', 'Affiliation': ''}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Pollard', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Landay', 'Affiliation': ''}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Asmuth', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002361']
2175,33035598,Predicting heart failure events in patients with coronary heart disease and impaired glucose tolerance: Insights from the Acarbose Cardiovascular Evaluation (ACE) trial.,"AIMS
Heart failure is a fatal complication of type 2 diabetes but little is known about its incidence in people with impaired glucose tolerance (IGT). We used Acarbose Cardiovascular Evaluation (ACE) trial data to identify predictors of hospitalisation for heart failure (hHF) or cardiovascular (CV) death in patients with coronary heart disease (CHD) and IGT randomised to acarbose or placebo.
METHODS
Independent hHF/CV death risk factors were determined using Cox proportional hazards models, with participants censored at first hHF event, CV death, or end of follow-up.
RESULTS
During median 5-year follow-up, the composite outcome of hHF/CV death occurred in 393 (6.0%) participants. Significant hHF/CV death multivariate predictors were higher age and plasma creatinine, and prior heart failure (HF), myocardial infarction (MI), atrial fibrillation (AF) and stroke. Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P = 0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P = 0.32).
CONCLUSIONS
Patients with CHD and IGT at greater risk of hHF/CV death were older with higher plasma creatinine, prior HF, MI, AF or stroke. Addition of acarbose to optimised CV therapy to reduce post-prandial glucose excursions did not reduce the risk of hHF/CV death or hHF.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, number NCT00829660, and the International Standard Randomised Controlled Trial Number registry, number ISRCTN91899513.",2020,"Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P=0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P=0.32).
","['people with impaired glucose tolerance (IGT', 'Patients with Coronary Heart Disease and Impaired Glucose Tolerance', 'patients with coronary heart disease (CHD']","['acarbose or placebo', 'placebo', 'acarbose to optimised CV therapy', 'Acarbose']","['plasma creatinine, as and prior heart failure (HF), myocardial infarction (MI), atrial fibrillation (AF) and stroke', 'risk of hHF/CV death or hHF', 'heart failure (hHF) or cardiovascular (CV) death', 'hHF/CV death', 'post-prandial glucose excursions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0151671', 'cui_str': 'Glucose tolerance decreased'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0587038', 'cui_str': 'Cardiovascular therapy'}]","[{'cui': 'C1278055', 'cui_str': 'Plasma creatinine measurement'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.56588,"Acarbose, compared with placebo, did not reduce hHF/CV death (hazard ratio [HR] 0.89, 95% CI 0.64-1.24, P=0.48) or hHF (HR 0.90, 95% CI 0.74-1.10, P=0.32).
","[{'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Wamil', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Charles A B', 'Initials': 'CAB', 'LastName': 'Scott', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Standl', 'Affiliation': 'Diabetes Research Group eV at Munich Helmholtz Centre, Munich, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK. Electronic address: rury.holman@dtu.ox.ac.uk.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108488']
2176,33035599,Liraglutide or insulin glargine treatments improves hepatic fat in obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks: A randomized placebo-controlled trial.,"BACKGROUND
Type 2 diabetes mellitus is closely related to nonalcoholic fatty liver disease(NAFLD). More and more attention has been paid to the efficacy of liraglutide in the treatment of NAFLD, but the clinical evidence is still insufficient.
OBJECTIVE
The purpose of this study was to use proton magnetic resonance spectroscopy (H-MRS) assessment of metformin alone poor blood glucose control of obese patients type 2 diabetes with NAFLD, added with insulin glargine, liraglutide or placebo effect in improving the fatty liver.
METHODS
This is a 26-week, single-center, prospective, randomized placebo-controlled study. From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital. The primary endpoints were the changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT)], from baseline to week 26 (end of treatment) and the changes in liraglutide group or insulin glargine group versus change in placebo group. Secondary endpoints included the changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI.
RESULTS
A total of 96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by metformin were randomized (1:1:1) to receive add-on insulin glargine, liraglutide, or placebo. After 26 weeks of treatment, compared to the placebo group, in the liraglutide and insulin glargine groups, IHCL significantly decreased from baseline to week 26 (liraglutide 26.4% ± 3.2% to 20.6% ± 3.9%, P < 0.05; insulin glargine 25.0% ± 4.3% to 22.6% ± 5.8%, P > 0.05). SAT and VAT decreased significantly in the liraglutide group and in the insulin glargine group (P < 0.05). ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs. - 24.5, P < 0.05; and ΔVAT, -47 vs. - 16.6, P > 0.05). In the liraglutide group, AST, ALT, and HOMA-IR decreased significantly from baseline. There was no significant difference in glucose-lowering among the three groups. During the treatment, the safety of the three groups performed well.
CONCLUSION
Compared with placebo, treatment with liraglutide plus an adequate dose of metformin (2000 g/ day) for 26 weeks is more effective in reducing IHCL, SAT and VAT in patients with type 2 diabetes and NAFLD. And it has additional advantages in weight loss, waist circumference reduction and liver function improvement.",2020,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","['From September 2016 to July 2018, 128 patients with type 2 diabetes and NAFLD were enrolled in the China joint logistics team 900 hospital', 'patients with type 2 diabetes and NAFLD', '96 patients with type 2 diabetes and NAFLD under inadequate glycemic control by', 'obese patients with type 2 diabetes and nonalcoholic fatty liver disease in twenty-six weeks', 'obese patients type 2 diabetes with NAFLD, added with']","['insulin glargine, liraglutide or placebo', 'proton magnetic resonance spectroscopy (H-MRS', 'liraglutide', 'insulin glargine, liraglutide, or placebo', 'metformin', 'placebo', 'insulin glargine', 'liraglutide and insulin glargine', 'Liraglutide or insulin glargine treatments']","['changes in intrahepatic content of lipid (IHCL), abdominal adiposity [subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT', 'changes in liver function (AST and ALT), glycemia (HbA1c and FPG), body weight, and BMI', 'blood glucose control', 'weight loss, waist circumference reduction and liver function improvement', 'hepatic fat', 'SAT and VAT', 'glucose-lowering', 'ΔSAT and ΔVAT', 'IHCL, SAT and VAT', 'IHCL', 'AST, ALT, and HOMA-IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0242415', 'cui_str': 'Logistics'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",96.0,0.0676648,"ΔSAT and ΔVAT were greater with liraglutide than insulin glargine, they were significantly different between the two groups (ΔSAT, -36 vs.-24.5, P < 0.05; and ΔVAT, -47 vs.-16.6, P > 0.05).","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Tian', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Team, Fuzong Clinical Medical College of Fujian Medical University, Fuzhou 365000, Fujian, China. Electronic address: xu98111@163.com.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108487']
2177,33039448,Estimating the Lifetime Benefits of Treatments for Heart Failure.,"OBJECTIVES
This study compared ways of describing treatment effects. The objective was to better explain to clinicians and patients what they might expect from a given treatment, not only in terms of relative and absolute risk reduction, but also in projections of long-term survival.
BACKGROUND
The restricted mean survival time (RMST) can be used to estimate of long-term survival, providing a complementary approach to more conventional metrics (e.g., absolute and relative risk), which may suggest greater benefits of therapy in high-risk patients compared with low-risk patients.
METHODS
Relative and absolute risk, as well as the RMST, were calculated in heart failure with reduced ejection fraction (HFrEF) trials.
RESULTS
As examples, in the RALES trial (more severe HFrEF), the treatment effect metrics for spironolactone versus placebo on heart failure hospitalization and/or cardiovascular death were a hazard ratio (HR) of 0.67 (95% confidence interval [CI]: 0.5 to 0.77), number needed to treat = 9 (7 to 14), and age extension of event-free survival +1.1 years (-0.1 to + 2.3 years). The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5). In patients in PARADIGM-HF aged younger than 65 years, the metrics for sacubitril/valsartan versus enalapril were 0.77 (95% CI: 0.68 to 0.88), 23 (15 to 44), and +1.7 (0.6 to 2.8) years; for those aged 65 years or older, the metrics were 0.83 (95% CI: 0.73 to 0.94), 29 (17 to 83), and +0.9 (0.2 to 1.6) years, which provided evidence of a greater potential life extension in younger patients. Similar observations were found for lower risk patients.
CONCLUSIONS
RMST event-free (and overall) survival estimates provided a complementary means of evaluating the effect of therapy in relation to age and risk. They also provided a clinically useful metric that should be routinely reported and used to explain the potential long-term benefits of a given treatment, especially to younger and less symptomatic patients.",2020,"The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5).",[],"['placebo', 'sacubitril/valsartan versus enalapril', 'HF (eplerenone vs. placebo', 'spironolactone']","['age extension of event-free survival', 'number needed to treat\xa0', 'heart failure hospitalization and/or cardiovascular death', 'RMST event-free (and overall) survival estimates', 'mean survival time (RMST']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0086595', 'cui_str': 'Mean Survival Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",,0.184145,"The corresponding metrics for EMPHASIS-HF (eplerenone vs. placebo in less severe HFrEF) were 0.64 (0.54 to 0.75), 14 (1 to 22), and +2.9 (1.2 to 4.5).","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom; National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), Nancy, France.'}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stienen', 'Affiliation': 'Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences. Amsterdam University Medical Center, University of Amsterdam, Amsterdam the Netherlands.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gregson', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Biostatistics, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'National Institute of Health and Medical Research (INSERM), Center for Clinical Multidisciplinary Research 1433, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network (F-CRIN) Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists (INI-CRCT), Nancy, France.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom. Electronic address: john.mcmurray@glasgow.ac.uk.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.08.004']
2178,33238964,Implementing stratified care for acute low back pain in primary care using the STarT Back instrument: a process evaluation within the context of a large pragmatic cluster randomized trial.,"BACKGROUND
Although risk-stratifying patients with acute lower back pain is a promising approach for improving long-term outcomes, efforts to implement stratified care in the US healthcare system have had limited success. The objectives of this process evaluation were to 1) examine variation in two essential processes, risk stratification of patients with low back pain and referral of high-risk patients to psychologically informed physical therapy and 2) identify barriers and facilitators related to the risk stratification and referral processes.
METHODS
We used a sequential mixed methods study design to evaluate implementation of stratified care at 33 primary care clinics (17 intervention, 16 control) participating in a larger pragmatic trial. We used electronic health record data to calculate: 1) clinic-level risk stratification rates (proportion of patients with back pain seen in the clinic over the study period who completed risk stratification questionnaires), 2) rates of risk stratification across different points in the clinical workflow (front desk, rooming, and time with clinician), and 3) rates of referral of high-risk patients to psychologically informed physical therapy among intervention clinics. We purposively sampled 13 clinics for onsite observations, which occurred in month 24 of the 26-month study.
RESULTS
The overall risk stratification rate across the 33 clinics was 37.8% (range: 14.7-64.7%). Rates were highest when patients were identified as having back pain by front desk staff (overall: 91.9%, range: 80.6-100%). Rates decreased as the patient moved further into the visit (rooming, 29.3% [range: 0-83.3%]; and time with clinician, 11.3% [range: 0-49.3%]. The overall rate of referrals of high-risk patients to psychologically informed physical therapy across the 17 intervention clinics was 42.1% (range: 8.3-70.8%). Barriers included staffs' knowledge and beliefs about the intervention, patients' needs, technology issues, lack of physician engagement, and lack of time. Adaptability of the processes was a facilitator.
CONCLUSIONS
Adherence to key stratified care processes varied across primary care clinics and across points in the workflow. The observed variation suggests room for improvement. Future research is needed to build on this work and more rigorously test strategies for implementing stratified care for patients with low back pain in the US healthcare system.
TRIAL REGISTRATION
Trial registration: ClinicalTrials.gov ( NCT02647658 ). Registered January 6, 2016.",2020,"Rates decreased as the patient moved further into the visit (rooming, 29.3% [range: 0-83.3%]; and time with clinician, 11.3% [range: 0-49.3%].","['patients with low back pain and referral of high-risk patients', 'patients with low back pain in the US healthcare system', '33 primary care clinics (17 intervention, 16 control) participating in a larger pragmatic trial', 'patients with back pain seen in the clinic over the study period who completed risk stratification questionnaires), 2) rates of risk stratification across different points in the clinical workflow (front desk, rooming, and time with clinician), and 3) rates of referral of high-risk patients to psychologically informed physical therapy among intervention clinics', 'We purposively sampled 13 clinics for onsite observations, which occurred in month 24 of the 26-month study']",[],"['overall rate of referrals of high-risk', 'Rates', 'overall risk stratification rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C3658215', 'cui_str': 'Practical Clinical Trials'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1710679', 'cui_str': 'Work Flow'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.100962,"Rates decreased as the patient moved further into the visit (rooming, 29.3% [range: 0-83.3%]; and time with clinician, 11.3% [range: 0-49.3%].","[{'ForeName': 'Addie', 'Initials': 'A', 'LastName': 'Middleton', 'Affiliation': 'New England Geriatric Research Education and Clinical Center, VA Boston Healthcare System, 150 South Huntington Avenue, Boston, MA, 02130-4817, USA. joyce.middleton@va.gov.'}, {'ForeName': 'G Kelley', 'Initials': 'GK', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Delitto', 'Affiliation': 'School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Saper', 'Affiliation': 'Department of Family Medicine, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gergen Barnett', 'Affiliation': 'Department of Family Medicine, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Stevans', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA, USA.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03800-6']
2179,33238965,Prevalence and correlates of depressive symptoms among high school adolescent girls in southern Uganda.,"BACKGROUND
In sub-Saharan Africa (SSA), adolescent girls and young women are three times more likely than boys to have depressive disorders. Understanding adolescents' unique and common vulnerabilities and protective factors is essential for the development of appropriate interventions and programming focused on child and adolescent mental health. This paper examines the prevalence and predictors of depressive symptoms among high school adolescent girls in southern Uganda.
METHODS
Baseline data from a longitudinal cluster randomized study involving 1260 adolescent girls (14-17 years), recruited from 47 secondary schools were utilized. Depressive symptoms were estimated using the 21-item Beck's Depression Inventory. Hierarchical linear regression modelling was utilized to estimate key predictors of depressive symptoms among adolescent girls.
RESULTS
Of the total sample, 16.35% (n = 206) reported severe depressive symptoms and almost one in every three adolescent girls interviewed (29.68%, n = 374) reported moderate symptoms. These symptoms were more prevalent among older adolescents (16 years and above). In addition, family relationships, social support, as well as measures of psychological wellbeing (self-concept and self-esteem) were all associated with lower levels of depressive symptoms. Hopelessness was associated with higher levels of depressive symptoms among adolescent girls.
CONCLUSION
Findings from this study indicate a high prevalence of depressive symptoms, especially among older adolescent girls. In addition, family support factors and adolescents' psychological wellbeing were associated with low levels of depressive symptoms -pointing to the need to strengthen family functioning and adolescent's psychological wellbeing to mitigate risks. Taken together, findings support increasing calls for early screening and detection of depressive symptoms to facilitate timely referral to care and treatment. Findings may also inform the development and incorporation of gender-specific mental health components in programming targeting adolescent girls, in low-resource communities in SSA.
TRIAL REGISTRATION
This trial was prospectively registered with ClinicalTrials.gov (registration number: NCT03307226 ) on 11 October 2017.",2020,"Hopelessness was associated with higher levels of depressive symptoms among adolescent girls.
","['adolescent girls and young women', 'high school adolescent girls in southern Uganda', 'adolescent girls', '1260 adolescent girls (14-17\u2009years), recruited from 47 secondary schools were utilized', 'older adolescent girls']",[],"['Depressive symptoms', 'psychological wellbeing (self-concept and self-esteem', 'depressive symptoms', 'Hopelessness', 'severe depressive symptoms', 'moderate symptoms']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0150041', 'cui_str': 'Feeling hopeless'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",1260.0,0.138357,"Hopelessness was associated with higher levels of depressive symptoms among adolescent girls.
","[{'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA. nabunyap@wustl.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Joelynn', 'Initials': 'J', 'LastName': 'Muwanga', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Eloho', 'Initials': 'E', 'LastName': 'Ighofose', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brathwaite', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Wilberforce', 'Initials': 'W', 'LastName': 'Tumwesige', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis, Brown School of Social Work, International Center for Child Health and Development (ICHAD), One Brookings Drive, St. Louis, MO, 63130, USA.'}]",BMC public health,['10.1186/s12889-020-09937-2']
2180,33047252,Use and Deprescribing of Potentially Inappropriate Medications in Frail Nursing Home Residents.,"BACKGROUND
The STOPPFrail criteria were developed to assist physicians in deprescribing medications among frail patients approaching end of life. We aimed to measure the prevalence of potentially inappropriate medications (PIMs) and to describe changes over time, using STOPPFrail, in frail nursing home residents (NHRs) with limited life expectancy included in a medication review trial.
METHODS
We conducted a post-hoc analysis of the COME-ON study, a cluster-controlled trial that evaluated the effect of a complex intervention on appropriateness of prescribing in Belgian nursing homes. We identified NHRs eligible for the application of STOPPFrail based on functional status, comorbidities, level of care and survival. PIM use was measured at baseline and at 8 months. Changes over time were compared in the control group (CG) and intervention group (IG).
RESULTS
At baseline, 308 NHRs met the STOPPFrail eligibility criteria, of whom 196 (64.1%) had one or more PIM. At 8 months, among the 218 NHRs who were alive, there was an absolute reduction in the prevalence of PIMs of 9.1% in the CG (p < 0.05) and 10.2% in the IG (p < 0.05). We found large reductions for some medications (e.g. proton pump inhibitors) but no reduction for others (e.g. calcium). The percentage of NHRs with one or more PIM discontinued without a new PIM initiated was higher in the IG than the CG but the difference was not significant (35.1% vs 23.6%, p = 0.127).
CONCLUSION
Among frail NHRs with poor survival prognosis, a significant and encouraging decrease in PIM prevalence over time was observed, probably facilitated by medication reviews. The overall prevalence of PIMs remained high, however.",2020,"At 8 months, among the 218 NHRs who were alive, there was an absolute reduction in the prevalence of PIMs of 9.1% in the CG (p < 0.05) and 10.2% in the IG (p < 0.05).","['frail nursing home residents (NHRs) with limited life expectancy included in a medication review trial', 'Belgian nursing homes', 'Frail Nursing Home Residents']",['complex intervention'],"['prevalence of PIMs', 'PIM use', 'PIM prevalence', 'percentage of NHRs']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",,0.0414043,"At 8 months, among the 218 NHRs who were alive, there was an absolute reduction in the prevalence of PIMs of 9.1% in the CG (p < 0.05) and 10.2% in the IG (p < 0.05).","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Fournier', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Anrys', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Beuscart', 'Affiliation': 'Univ. Lille, CHU Lille, ULR 2694 - METRICS : Évaluation des technologies de santé et des pratiques médicales, 59000, Lille, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Dalleur', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Henrard', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Foulon', 'Affiliation': 'Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'Louvain Drug Research Institute, Clinical Pharmacy Research Group, Université Catholique de Louvain, Avenue Mounier 72/B1.72.02, 1200 Woluwe-Saint-Lambert, Brussels, Belgium. anne.spinewine@uclouvain.be.'}]",Drugs & aging,['10.1007/s40266-020-00805-7']
2181,33050179,Effectiveness of a Physical Therapeutic Exercise Programme for Caregivers of Dependent Patients: A Pragmatic Randomised Controlled Trial from Spanish Primary Care.,"Female family caregivers (FFCs) constitute one of the basic supports of socio-health care for dependence in developed countries. The care provided by FFCs may impact their physical and mental health, negatively affecting their quality of life. In order to alleviate the consequences of providing care on FFCs, the Spanish Public Health System has developed the family caregiver care programme (FCCP) to be applied in primary care (PC) centres. The effectiveness of this programme is limited. To date, the addition of a physical therapeutic exercise (PTE) programme to FCCP has not been evaluated. A randomised multicentre clinical trial was carried out in two PC centres of the Spanish Public Health System. In total, 68 FFCs were recruited. The experimental group (EG) performed the usual FCCP (4 sessions, 6 h) added to a PTE programme (36 sessions in 12 weeks) whereas the control group performed the usual FCCP performed in PC. The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance). Differences between the groups ( p < 0.05) were clinically relevant in favour of the EG. The experimental treatment generates high levels of satisfaction.",2020,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","['Caregivers of Dependent Patients', 'two PC centres of the Spanish Public Health System', 'In total, 68 FFCs were recruited', 'Female family caregivers (FFCs']","['physical therapeutic exercise (PTE) programme', 'usual FCCP (4 sessions, 6 h) added to a PTE programme', 'usual FCCP performed in PC', 'Physical Therapeutic Exercise Programme']","['health-related physical condition', 'quality of life', 'subjective burden', 'anxiety']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0581116', 'cui_str': 'Dependent patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.0437757,"The experimental treatment improved quality of life (d = 1.17 in physical component summary), subjective burden (d = 2.38), anxiety (d = 1.52), depression (d = 1.37) and health-related physical condition (d = 2.44 in endurance).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Montero-Cuadrado', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Galán-Martín', 'Affiliation': 'Unit for Active Coping Strategies for Pain in Primary Care, East-Valladolid Primary Care Management, Castilla and Leon Public Health System (Sacyl), 47011 Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-Sánchez', 'Affiliation': 'Department of Physical Activity and Sports Sciences, University Pontificia of Salamanca, 37002 Salamanca, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Agustín', 'Initials': 'A', 'LastName': 'Mayo-Iscar', 'Affiliation': 'Department of Statistics and Operational Research and IMUVA, University of Valladolid, 47005 Valladolid, Spain.'}, {'ForeName': 'Ántonio', 'Initials': 'Á', 'LastName': 'Cuesta-Vargas', 'Affiliation': 'Department of Physiotherapy, Faculty of Heath Sciences, University of Malaga, 19071 Málaga, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17207359']
2182,33239038,"Effect of ""motivational interviewing"" and ""information, motivation, and behavioral skills"" counseling interventions on choosing the mode of delivery in pregnant women: a study protocol for a randomized controlled trial.","BACKGROUND
Cesarean section is an important surgical procedure, when normal vaginal delivery imposes a risk to mother and/or baby. The World Health Organization states the ideal rate for Cesarean section to be between 10 and 15% of all births. In recent decades, the rate has been increased dramatically worldwide. This paper explains the protocol of a randomized controlled trial that aims to compare the effect of ""motivational interviewing"" and ""information, motivation, and behavioral skills"" counseling interventions on choosing mode of delivery in pregnant women.
METHODS
A four-armed, parallel-design randomized controlled trial will be conducted on pregnant women. One hundred and twenty women will be randomly assigned to four groups including three intervention groups and one control group. The intervention groups included the following: (1) motivational interviewing; (2) face-to-face information, motivation, and behavioral skills model; and (3) information, motivation, and behavioral skills model provided using a mobile application. The inclusion criteria include being literate, being in gestational age from 24 to 32 weeks, being able to speak Persian, having no complications in the current pregnancy, having no indications for Cesarean section, and having enough time to participate in the intervention. The primary outcome of the study is the mode of delivery. The secondary outcomes are women's intention to undergo Cesarean section and women's self-efficacy.
DISCUSSION
The interventions of this protocol have been programmed to reduce unnecessary Cesarean sections. Findings may contribute to a rise in normal vaginal delivery, and the effective intervention may be extended for use in national Cesarean section plans.
TRIAL REGISTRATION
Iran Randomized Clinical Trial Center IRCT20151208025431N7 . Registered on December 07, 2018.",2020,"The intervention groups included the following: (1) motivational interviewing; (2) face-to-face information, motivation, and behavioral skills model; and (3) information, motivation, and behavioral skills model provided using a mobile application.","['One hundred and twenty women', 'The inclusion criteria include being literate, being in gestational age from 24 to 32\u2009weeks, being able to speak Persian, having no complications in the current pregnancy, having no indications for Cesarean section, and having enough time to participate in the intervention', 'pregnant women']","['motivational interviewing; (2) face-to-face information, motivation, and behavioral skills model; and (3) information, motivation, and behavioral skills model provided using a mobile application', 'motivational interviewing"" and ""information, motivation, and behavioral skills"" counseling interventions']","[""women's intention to undergo Cesarean section and women's self-efficacy""]","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0564215', 'cui_str': 'Able to speak'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0521090', 'cui_str': 'No indication of'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",120.0,0.105928,"The intervention groups included the following: (1) motivational interviewing; (2) face-to-face information, motivation, and behavioral skills model; and (3) information, motivation, and behavioral skills model provided using a mobile application.","[{'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Shirzad', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Shakibazadeh', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran. shakibazadeh@tums.ac.ir.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Rahimi Foroushani', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrandokht', 'Initials': 'M', 'LastName': 'Abedini', 'Affiliation': 'Maternal Health Department, Ministry of Health, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Poursharifi', 'Affiliation': 'Department of Psychology, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Babaei', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04865-3']
2183,33239039,Individualized flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation: a prospective randomized porcine study.,"BACKGROUND
Flow-controlled ventilation is a novel ventilation method which allows to individualize ventilation according to dynamic lung mechanic limits based on direct tracheal pressure measurement at a stable constant gas flow during inspiration and expiration. The aim of this porcine study was to compare individualized flow-controlled ventilation (FCV) and current guideline-conform pressure-controlled ventilation (PCV) in long-term ventilation.
METHODS
Anesthetized pigs were ventilated with either FCV or PCV over a period of 10 h with a fixed FiO 2 of 0.3. FCV settings were individualized by compliance-guided positive end-expiratory pressure (PEEP) and peak pressure (P peak ) titration. Flow was adjusted to maintain normocapnia and the inspiration to expiration ratio (I:E ratio) was set at 1:1. PCV was performed with a PEEP of 5 cm H 2 O and P peak was set to achieve a tidal volume (V T ) of 7 ml/kg. The respiratory rate was adjusted to maintain normocapnia and the I:E ratio was set at 1:1.5. Repeated measurements during observation period were assessed by linear mixed-effects model.
RESULTS
In FCV (n = 6), respiratory minute volume was significantly reduced (6.0 vs 12.7, MD - 6.8 (- 8.2 to - 5.4) l/min; p < 0.001) as compared to PCV (n = 6). Oxygenation was improved in the FCV group (paO 2 119.8 vs 96.6, MD 23.2 (9.0 to 37.5) Torr; 15.97 vs 12.87, MD 3.10 (1.19 to 5.00) kPa; p = 0.010) and CO 2 removal was more efficient (paCO 2 40.1 vs 44.9, MD - 4.7 (- 7.4 to - 2.0) Torr; 5.35 vs 5.98, MD - 0.63 (- 0.99 to - 0.27) kPa; p = 0.006). P peak and driving pressure were comparable in both groups, whereas PEEP was significantly lower in FCV (p = 0.002). Computed tomography revealed a significant reduction in non-aerated lung tissue in individualized FCV (p = 0.026) and no significant difference in overdistended lung tissue, although a significantly higher V T was applied (8.2 vs 7.6, MD 0.7 (0.2 to 1.2) ml/kg; p = 0.025).
CONCLUSION
Our long-term ventilation study demonstrates the applicability of a compliance-guided individualization of FCV settings, which resulted in significantly improved gas exchange and lung tissue aeration without signs of overinflation as compared to best clinical practice PCV.",2020,"Computed tomography revealed a significant reduction in non-aerated lung tissue in individualized FCV (p = 0.026) and no significant difference in overdistended lung tissue, although a significantly higher V T was applied (8.2 vs 7.6, MD 0.7 (0.2 to 1.2) ml/kg; p = 0.025).
",['Anesthetized pigs were ventilated with either'],"['clinical practice pressure-controlled ventilation', 'individualized flow-controlled ventilation (FCV) and current guideline-conform pressure-controlled ventilation (PCV', 'FCV or PCV', 'Individualized flow-controlled ventilation', 'PCV']","['compliance-guided positive end-expiratory pressure (PEEP) and peak pressure (P peak ) titration', 'overdistended lung tissue', 'respiratory minute volume', 'respiratory rate', 'Oxygenation', 'P peak and driving pressure']","[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0564626', 'cui_str': 'Pressure controlled ventilation'}, {'cui': 'C0419011', 'cui_str': 'Controlled ventilation'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0428679', 'cui_str': 'Minute volume'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.033212,"Computed tomography revealed a significant reduction in non-aerated lung tissue in individualized FCV (p = 0.026) and no significant difference in overdistended lung tissue, although a significantly higher V T was applied (8.2 vs 7.6, MD 0.7 (0.2 to 1.2) ml/kg; p = 0.025).
","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Spraider', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Martini', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Medical University of Innsbruck, Innsbruck, Austria. judith.martini@i-med.ac.at.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Abram', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Putzer', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Glodny', 'Affiliation': 'Department of Radiology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hell', 'Affiliation': 'Department of Mathematics, Faculty of Mathematics, Computer Science and Physics, University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Barnes', 'Affiliation': 'University of Greenwich, London, UK.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Enk', 'Affiliation': 'Faculty of Medicine, University of Münster, Münster, Germany.'}]","Critical care (London, England)",['10.1186/s13054-020-03325-3']
2184,33239044,CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomised controlled phase II clinical trial.,"BACKGROUND
The inflammatory response after aneurysmal subarachnoid haemorrhage (aSAH) has been associated with early brain injury, delayed cerebral ischaemia, poor functional outcome, and case fatality. In experimental SAH studies, complement C5 antibodies administered shortly after SAH reduced brain injury with approximately 40%. Complement component C5 may be a new therapeutic target to reduce brain injury and hereby improve the outcome after aSAH. We aim to investigate the pharmacodynamic efficacy and safety of eculizumab (complement C5 antibody) in patients with aSAH.
METHODS
A randomised, controlled, open-label, phase II clinical trial with blinded outcome assessment. Eculizumab (1200 mg) is administered intravenously < 12 h, on day 3 and on day 7 after ictus. Patients in the intervention group receive prophylactic antibiotics for 4 weeks, and those with a central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy for 4 weeks. The primary outcome is C5a concentration in the cerebrospinal fluid (CSF) on day 3 after ictus. Secondary outcomes include the occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes. We aim to evaluate 26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group. To compensate for early case fatality and inability to obtain CSF, we will include 20 patients per group.
DISCUSSION
The CLASH trial is the first trial to investigate the pharmacodynamic efficacy and safety of eculizumab in the early phase after aSAH.
TRIAL REGISTRATION
Netherlands Trial Register NTR6752 . Registered on 27 October 2017 European Clinical Trials Database (EudraCT) 2017-004307-51.",2020,"Secondary outcomes include the occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes.","['20 patients per group', '26 patients with CSF assessments, 13 in the intervention group and 13 in the comparator group', 'patients with aSAH', 'aneurysmal subarachnoid haemorrhage (aSAH', 'brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH', 'Registered on 27 October 2017 European Clinical Trials Database (EudraCT) 2017-004307-51']","['CompLement C5 Antibodies', 'central line or an external ventricular shunt and a positive fungal or yeast culture also receive prophylactic antifungal therapy', 'eculizumab (complement C5 antibody', 'prophylactic antibiotics', 'Eculizumab', 'eculizumab', 'NTR6752 ']","['C5a concentration in the cerebrospinal fluid (CSF', 'pharmacodynamic efficacy and safety', 'occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439651', 'cui_str': 'Aneurysmal'}, {'cui': 'C0038525', 'cui_str': 'Subarachnoid hemorrhage'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0009519', 'cui_str': 'Complement component C5'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0728823', 'cui_str': 'Ventricular shunt'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C1294288', 'cui_str': 'Yeast culture'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0678026', 'cui_str': 'Antifungal therapy'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C0362063', 'cui_str': 'Other prophylactic chemotherapy'}]","[{'cui': 'C0009521', 'cui_str': 'C5a Complement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.107038,"Secondary outcomes include the occurrence of adverse events, inflammatory parameters in the blood and CSF, cerebral infarction on magnetic resonance imaging, and clinical and cognitive outcomes.","[{'ForeName': 'Inez', 'Initials': 'I', 'LastName': 'Koopman', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Centre, University Medical Centre Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, the Netherlands. i.koopman-2@umcutrecht.nl.'}, {'ForeName': 'Gabriel J E', 'Initials': 'GJE', 'LastName': 'Rinkel', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Centre, University Medical Centre Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, the Netherlands.'}, {'ForeName': 'Mervyn D I', 'Initials': 'MDI', 'LastName': 'Vergouwen', 'Affiliation': 'Department of Neurology and Neurosurgery, UMC Utrecht Brain Centre, University Medical Centre Utrecht, Utrecht University, Bolognalaan 2-48, 3584 CJ, Utrecht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04838-6']
2185,33064182,"The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial.","AIMS/HYPOTHESIS
We aimed to investigate the short-term efficacy and safety of three glucose-lowering interventions in overweight or obese individuals with prediabetes defined by HbA 1c .
METHODS
The PRE-D Trial was a randomised, controlled, parallel, multi-arm, open-label, non-blinded trial performed at Steno Diabetes Center Copenhagen, Gentofte, Denmark. One hundred and twenty participants with BMI ≥25 kg/m 2 , 30-70 years of age, and prediabetes (HbA 1c 39-47 mmol/mol [5.7-6.4%]) were randomised 1:1:1:1 to dapagliflozin (10 mg once daily), metformin (1700 mg daily), interval-based exercise (5 days/week, 30 min/session) or control (habitual lifestyle). Participants were examined at baseline and at 6, 13 and 26 weeks after randomisation. The primary outcome was the 13 week change in glycaemic variability (calculated as mean amplitude of glycaemic excursions [MAGE]) determined using a continuous glucose monitoring system (pre-specified minimal clinically important difference in MAGE ∼30%).
RESULTS
One hundred and twelve participants attended the examination at 13 weeks and 111 attended the follow-up visit at 26 weeks. Compared with the control group, there was a small decrease in MAGE in the dapagliflozin group (17.1% [95% CI 0.7, 30.8], p = 0.042) and a small, non-significant, reduction in the exercise group (15.3% [95% CI -1.2, 29.1], p = 0.067), whereas MAGE was unchanged in the metformin group (0.1% [95% CI -16.1, 19.4], p = 0.991)). Compared with the metformin group, MAGE was 17.2% (95% CI 0.8, 30.9; p = 0.041) lower in the dapagliflozin group and 15.4% (95% CI -1.1, 29.1; p = 0.065) lower in the exercise group after 13 weeks, with no difference between exercise and dapagliflozin (2.2% [95% CI -14.8, 22.5], p = 0.815). One serious adverse event occurred in the control group (lung cancer).
CONCLUSIONS/INTERPRETATION
Treatment with dapagliflozin and interval-based exercise lead to similar but small improvements in glycaemic variability compared with control and metformin therapy. The clinical importance of these findings in prediabetes is uncertain.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02695810 FUNDING: The study was funded by the Novo Nordisk Foundation, AstraZeneca AB, the Danish Innovation Foundation, the University of Copenhagen and Ascensia Diabetes Care Denmark ApS Graphical abstract.",2021,"Compared with the control group, there was a small decrease in MAGE in the dapagliflozin group (17.1% [95% CI 0.7, 30.8], p = 0.042) and a small, non-significant, reduction in the exercise group (15.3% [95% CI -1.2, 29.1], p = 0.067), whereas MAGE was unchanged in the metformin group (0.1% [95% CI -16.1, 19.4], p = 0.991)).","['kg/m 2 , 30-70\xa0years of age, and prediabetes (HbA 1c 39-47\xa0mmol/mol [5.7-6.4', 'overweight or obese individuals with prediabetes defined by HbA 1c ', 'overweight or obese individuals with prediabetes (the PRE-D Trial', 'One hundred and twenty participants with BMI ≥25', 'One hundred and twelve participants attended the examination at 13\xa0weeks and 111 attended the follow-up visit at 26\xa0weeks']","['dapagliflozin, metformin or exercise', 'glucose-lowering interventions', 'metformin', 'dapagliflozin']","['continuous glucose monitoring system', 'MAGE', 'glycaemic variability', '13\xa0week change in glycaemic variability (calculated as mean amplitude of glycaemic excursions [MAGE']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.157051,"Compared with the control group, there was a small decrease in MAGE in the dapagliflozin group (17.1% [95% CI 0.7, 30.8], p = 0.042) and a small, non-significant, reduction in the exercise group (15.3% [95% CI -1.2, 29.1], p = 0.067), whereas MAGE was unchanged in the metformin group (0.1% [95% CI -16.1, 19.4], p = 0.991)).","[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Færch', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark. kristine.faerch@regionh.dk.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Blond', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Bruhn', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Amadid', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Dorte', 'Initials': 'D', 'LastName': 'Vistisen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kim K B', 'Initials': 'KKB', 'LastName': 'Clemmensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Camilla T R', 'Initials': 'CTR', 'LastName': 'Vainø', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Pedersen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tvermosegaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Dejgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Marit E', 'Initials': 'ME', 'LastName': 'Jørgensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}]",Diabetologia,['10.1007/s00125-020-05306-1']
2186,33043659,Mitral valve surgery combined with on-pump versus off-pump myocardial revascularization: A prospective randomized analysis with midterm follow-up.,"BACKGROUND
The aim of the study was to compare results off-pump coronary artery bypass (OPCAB) combined mitral valve reconstruction (MVR) with standard on-pump approach.
METHODS
From January 2014 to December 2017, a total of 53 patients received a combined myocardial revascularization and MVR for multivessel coronary artery disease (CAD) complicated by severe ischemic mitral regurgitation (IMR). All the subjects were divided into two groups: group I: 27 patients, received OPCAB + MVR, and group II (control group): 26 patients with on-pump myocardial revascularization (ONCAB) + MVR.
RESULTS
The aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times were longer in group II, 47.0 (44.0; 55.0) vs 94.5 (89.75; 105.5) minutes, P < .05 and 70.0 (63.0; 77.0) vs 138.5 (127.0; 157.5) minutes, P < .05, respectively. Evaluation of major clinical events showed that the implementation of the off-pump stage of myocardial revascularization in patients with severe IMR did not lead to significant changes in the mortality and postoperative complications. Furthermore, its use did not affect the volume of blood loss and need for blood transfusion, the duration of mechanical ventilation, the need for inotropic therapy, as well as the duration of the patient's resuscitation and the total duration of hospitalization, with the one exception: the troponin-T level increase in the OPCAB + MVR group was less than in the ONCAB + MVR group.
CONCLUSION
OPCAB combined MVR in patients with CAD and severe IMR can be performed with shorter CPB and ACC times, and lower troponin-T level after surgery, without reducing the risk of surgical complications.",2020,"The aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times were longer in group II, 47.0 (44.0; 55.0) vs 94.5 (89.75; 105.5) minutes, P < .05 and 70.0 (63.0; 77.0) vs 138.5 (127.0; 157.5) minutes, P < .05, respectively.","['patients with severe IMR', 'patients with CAD and severe IMR', 'for multivessel coronary artery disease (CAD) complicated by severe ischemic mitral regurgitation (IMR', 'From January 2014 to December 2017, a total of 53 patients received a']","['OPCAB\u2009+\u2009MVR, and group II (control group): 26 patients with on-pump myocardial revascularization (ONCAB)\u2009+\u2009MVR', 'pump coronary artery bypass (OPCAB) combined mitral valve reconstruction (MVR', 'combined myocardial revascularization and MVR', 'Mitral valve surgery combined with on-pump versus off-pump myocardial revascularization']","['troponin-T level', 'aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times', 'total duration of hospitalization', 'troponin-T level increase', 'volume of blood loss and need for blood transfusion, the duration of mechanical ventilation', 'risk of surgical complications', 'mortality and postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4087284', 'cui_str': 'Ischaemic mitral regurgitation'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0026264', 'cui_str': 'Mitral valve structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0027056', 'cui_str': 'Myocardial revascularization'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",26.0,0.0281927,"The aortic cross-clamp (ACC) and cardio-pulmonary bypass (CPB) times were longer in group II, 47.0 (44.0; 55.0) vs 94.5 (89.75; 105.5) minutes, P < .05 and 70.0 (63.0; 77.0) vs 138.5 (127.0; 157.5) minutes, P < .05, respectively.","[{'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Zavolozhin', 'Affiliation': 'Department of Surgery, Arkhangelsk State Medical University, Arkhangelsk, Russia.'}, {'ForeName': 'Alexey', 'Initials': 'A', 'LastName': 'Shonbin', 'Affiliation': 'Department of Surgery, Arkhangelsk State Medical University, Arkhangelsk, Russia.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Bystrov', 'Affiliation': 'Department of Cardiac Surgery, City Hospital No 1, Arkhangelsk, Russia.'}, {'ForeName': 'Soslan', 'Initials': 'S', 'LastName': 'Enginoev', 'Affiliation': 'Department of Cardiac Surgery, FSBI Federal Centre for Cardiovascular Surgery of the Ministry of Health of the Russian Federation, Astrakhan, Russia.'}]",Journal of cardiac surgery,['10.1111/jocs.14861']
2187,33039321,Promoting fertility awareness and preconception health using a chatbot: a randomized controlled trial.,"RESEARCH QUESTION
What are the effects of using a fertility education chatbot, i.e. automatic conversation programme, on knowledge, intentions to improve preconception behaviour and anxiety?
DESIGN
A three-armed, randomized controlled trial was conducted using an online social research panel. Participants included 927 women aged 20-34 years who were randomly allocated to one of three groups: a fertility education chatbot (intervention group), a document about fertility and preconception health (control group 1) or a document about an irrelevant topic (control group 2). Participants' scores on the Cardiff Fertility Knowledge Scale and the State-Trait Anxiety Inventory, their intentions to optimize preconception behaviours, e.g. taking folic acid, and the free-text feedback provided by chatbot users were assessed.
RESULTS
A repeated-measures analysis of variance showed significant fertility knowledge gains after the intervention in the intervention group (+9.1 points) and control group 1 (+14.9 points) but no significant change in control group 2 (+1.1 points). Post-test increases in the intentions to optimize behaviours were significantly higher in the intervention group than in control group 2, and were similar to those in control group 1. Post-test state anxiety scores were significantly lower in the intervention group than in control group 1 and control group 2. User feedbacks about the chatbot suggested technical limitations, e.g. low comprehension of users' words, and pros and cons of using the chatbot, e.g. convenient versus coldness.
CONCLUSIONS
Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small. Further technical development and exploration of personal affinity for technology is required.",2020,"CONCLUSIONS
Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small.",['Participants included 927 women aged 20-34 years'],"['fertility education chatbot (intervention group), a document about fertility and preconception health (control group 1) or a document about an irrelevant topic (control group 2']","['intentions to optimize behaviours', 'Cardiff Fertility Knowledge Scale and the State-Trait Anxiety Inventory, their intentions to optimize preconception behaviours, e.g. taking folic acid, and the free-text feedback provided by chatbot users', 'fertility knowledge gains', 'Post-test state anxiety scores']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1689849', 'cui_str': 'Fertility education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",927.0,0.0421775,"CONCLUSIONS
Providing fertility education using a chatbot improved fertility knowledge and intentions to optimize preconception behaviour without increasing anxiety, but the improvement in knowledge was small.","[{'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Maeda', 'Affiliation': 'Department of Environmental Health Science and Public Health, Akita University Graduate School of Medicine, Akita 010-8543, Japan. Electronic address: erimaeda@med.akita-u.ac.jp.'}, {'ForeName': 'Akane', 'Initials': 'A', 'LastName': 'Miyata', 'Affiliation': 'Reproduction Center, Dokkyo Medical University, Saitama 343-8555, Japan.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Boivin', 'Affiliation': 'Cardiff Fertility Studies Research Group, School of Psychology, Cardiff University, Cardiff CF10 3AT, UK.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Environmental Health Science and Public Health, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Yukiyo', 'Initials': 'Y', 'LastName': 'Kumazawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Shirasawa', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': ""Umegaoka Women's Clinic, Tokyo 154-0022, Japan.""}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Terada', 'Affiliation': 'Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita 010-8543, Japan.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.09.006']
2188,33040311,"The Effect of Low-Level Light Therapy on Capsaicin-Induced Peripheral and Central Sensitization in Healthy Volunteers: A Double-Blinded, Randomized, Sham-Controlled Trial.","INTRODUCTION
Several clinical trials have demonstrated that low-level light therapy (LLLT), a method of photobiomodulation, is an effective analgetic treatment. However, the mechanism of action has not yet been finally clarified. In particular, unanswered questions include whether it only affects peripheral or whether it also affects the spinal or supraspinal level. This study aimed to evaluate the effect of low-level light therapy on primary and secondary hyperalgesia in a human pain model.
METHODS
This study was planned as a randomized, sham-controlled, and double-blinded trial with repeated measures within subject design. Capsaicin was applied on both forearms of ten healthy volunteers to induce peripheral and central sensitization. One forearm was treated with low-level light therapy; the other served as sham control.
RESULTS
Low-level light therapy significantly increased the mechanical pain threshold, heat pain threshold, and decreased pain intensity.
CONCLUSIONS
Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization. These effects-especially in the absence of reported side effects-make low-level light therapy a promising tool in pain management. The application of low-level light therapy to treat chronic pain should be considered for further clinical trials.",2020,"Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization.","['ten healthy volunteers to induce peripheral and central sensitization', 'Healthy Volunteers']","['low-level light therapy', 'Capsaicin', 'Low-Level Light Therapy', 'low-level light therapy (LLLT']","['mechanical pain threshold, heat pain threshold, and decreased pain intensity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0234252', 'cui_str': 'Mechanical pain'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",10.0,0.106331,"Our data indicate that low-level light therapy is effective at reducing the heat and mechanical pain threshold in a human pain model, pointing to a significant modulating effect on peripheral and central sensitization.","[{'ForeName': 'Kordula', 'Initials': 'K', 'LastName': 'Lang-Illievich', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Raimund', 'Initials': 'R', 'LastName': 'Winter', 'Affiliation': 'Division of Plastic, Aesthetic and Reconstructive Surgery, Department of Surgery, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Rumpold-Seitlinger', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Schicho', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dorn', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Klivinyi', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Helmar', 'Initials': 'H', 'LastName': 'Bornemann-Cimenti', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, Medical University of Graz, Graz, Austria. helmar.bornemann@medunigraz.at.'}]",Pain and therapy,['10.1007/s40122-020-00205-0']
2189,33045193,Home-based oral self-testing for absent and declining individuals during a door-to-door HIV testing campaign in rural Lesotho (HOSENG): a cluster-randomised trial.,"BACKGROUND
In sub-Saharan Africa, home-based HIV testing is validated and accepted, but coverage is low because household members are often absent during home-based testing campaigns. We aimed to measure the effect of a secondary distribution of oral-fluid HIV self-tests on coverage during home-based testing in rural Lesotho.
METHODS
The Home-Based Self-Testing (HOSENG) trial was a cluster-randomised, non-blinded superiority trial in rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong). Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older. The HOSENG trial provided a recruitment platform for the interlinked Village-Based Refill of Antiretroviral Therapy (VIBRA) trial. Villages were randomly assigned 1:1:1:1 with block sizes of four to one of four groups: VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention. Randomisation was stratified by district, village size, and access to the nearest health facility. An independent statistician was responsible for the computer-generated randomisation list. In the intervention group, oral-fluid HIV self-tests were left for absent or declining household members (aged ≥12 years) during a home visit from the HIV testing campaign team. One present household member was trained on self-test use. Distributed self-tests were followed up by village health workers. In control village clusters, absent or declining household members were referred to the clinic for HIV testing. The primary outcome was HIV testing coverage among all household members aged 12 years or older within 120 days, defined as a confirmed HIV test result or known status, reported in testing registers at the health facilities or on the follow-up forms of the village health worker. Adjusted random-effects logistic regression with individuals as the unit of analysis was used. This trial is registered with ClinicalTrials.gov, NCT03598686.
FINDINGS
Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members). In the control group, 38 (3%) of 1455 initially absent or declining household members tested at a clinic within 120 days. In the intervention group, 841 (53%) of 1601 initially absent or declining household members had a confirmed status within 120 days; 12 (1%) of 841 tested at the clinic and 829 (99%) used their self-test kit. This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
INTERPRETATION
Secondary distribution of oral-fluid HIV self-tests during home-based testing increases testing coverage substantially and thus presents a promising add-on during testing campaigns.
FUNDING
Swiss National Science Foundation.",2020,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","['Between July 26, 2018, and Dec 12, 2018, 3091 consenting households with 7816 household members aged 12 years or older were enrolled and randomly assigned (intervention: 57 village clusters, 1620 households, 4174 household members; control: 49 village clusters, 1471 households, 3642 household members', 'rural villages in the catchment area of 20 health facilities of two districts in Lesotho (Butha-Buthe and Mokhotlong', 'rural Lesotho', 'Eligible villages had a consenting village chief and at least one registered village health worker; eligible households had a consenting representative aged 18 years or older']","['oral-fluid HIV self-tests', 'VIBRA control and HOSENG control; VIBRA control and HOSENG intervention; VIBRA intervention and HOSENG control; and VIBRA intervention and HOSENG intervention']",['HIV testing coverage'],"[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0023376', 'cui_str': 'Lesotho'}, {'cui': 'C0087157', 'cui_str': 'Village Health Worker'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}]",,0.134167,"This resulted in a testing coverage of 2201 (60%) of 3642 in the control group versus 3386 (81%) of 4174 in the intervention group (odds ratio 3·00 [95% CI 2·52-3·59]; p<0·0001).
","[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Amstutz', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Thabo Ishmael', 'Initials': 'TI', 'LastName': 'Lejone', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Lefu', 'Initials': 'L', 'LastName': 'Khesa', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Muhairwe', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Moniek', 'Initials': 'M', 'LastName': 'Bresser', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Vanobberghen', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mathebe', 'Initials': 'M', 'LastName': 'Kopo', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Mpho', 'Initials': 'M', 'LastName': 'Kao', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Bienvenu Lengo', 'Initials': 'BL', 'LastName': 'Nsakala', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Katleho', 'Initials': 'K', 'LastName': 'Tlali', 'Affiliation': 'SolidarMed, Partnerships for Health, Maseru, Lesotho.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Klimkait', 'Affiliation': 'University of Basel, Basel, Switzerland; Molecular Virology, Department of Biomedicine, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Battegay', 'Affiliation': 'Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Niklaus Daniel', 'Initials': 'ND', 'LastName': 'Labhardt', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; University of Basel, Basel, Switzerland. Electronic address: n.labhardt@swisstph.ch.'}, {'ForeName': 'Tracy Renée', 'Initials': 'TR', 'LastName': 'Glass', 'Affiliation': 'Clinical Research Unit, Department of Medicine, Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30233-2']
2190,33049433,Selecting the optimal treatment for a depressed individual: Clinical judgment or statistical prediction?,"BACKGROUND
Optimizing treatment selection is a way to enhance treatment success in major depressive disorder (MDD). In clinical practice, treatment selection heavily depends on clinical judgment. However, research has consistently shown that statistical prediction is as accurate - or more accurate - than predictions based on clinical judgment. In the context of new technological developments, the current aim was to compare the accuracy of clinical judgment versus statistical predictions in selecting cognitive therapy (CT) or interpersonal psychotherapy (IPT) for MDD.
METHODS
Data came from a randomized trial comparing CT (n=76) with IPT (n=75) for MDD. Prior to randomization, therapists' recommendations were formulated during multidisciplinary staff meetings. Statistical predictions were based on Personalized Advantage Index models. Primary outcomes were post-treatment and 17-month follow-up depression severity. Secondary outcome was treatment dropout.
RESULTS
Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment. This difference was not found for recommended versus non-recommended treatments based on clinical judgment. Moreover, for individuals with an IPT recommendation by therapists, higher post-treatment and follow-up depression severity was found for those that actually received IPT compared to those that received CT. Recommendations based on statistical prediction and clinical judgment were not associated with differences in treatment dropout.
LIMITATIONS
Information on the clinical reasoning behind therapist recommendations was not collected, and statistical predictions were not externally validated.
CONCLUSIONS
Statistical prediction outperforms clinical judgment in treatment selection for MDD and has the potential to personalize treatment strategies.",2020,"RESULTS
Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","['n=76) with IPT (n=75) for MDD', 'major depressive disorder (MDD']","['CT', 'IPT', 'cognitive therapy (CT) or interpersonal psychotherapy (IPT']","['treatment dropout', 'post-treatment and 17-month follow-up depression severity']","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0871787', 'cui_str': 'Interpersonal psychotherapy'}]","[{'cui': 'C0030686', 'cui_str': 'Patient Dropouts'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",76.0,0.0177431,"RESULTS
Individuals receiving treatment according to their statistical prediction were less depressed at post-treatment and follow-up compared to those receiving their predicted non-indicated treatment.","[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Bronswijk', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands. Electronic address: suzanne.vanbronswijk@maastrichtuniversity.nl.'}, {'ForeName': 'Lotte H J M', 'Initials': 'LHJM', 'LastName': 'Lemmens', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}, {'ForeName': 'Marcus J H', 'Initials': 'MJH', 'LastName': 'Huibers', 'Affiliation': 'Department of Clinical Psychology, VU University Amsterdam, Van der Boechorststraat 1, 1081 BT Amsterdam, the Netherlands; Department of Psychology, University of Pennsylvania, 3720 Walnut Street, Philadelphia, PA 19104-6241, USA.'}, {'ForeName': 'Frenk P M L', 'Initials': 'FPML', 'LastName': 'Peeters', 'Affiliation': 'Department of Clinical Psychological Science, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200, MD Maastricht, the Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.135']
2191,33049434,Acute Effects of Cannabis on Symptoms of Obsessive-Compulsive Disorder.,"BACKGROUND
Little is known about the the acute effects of cannabis on symptoms of OCD in humans. Therefore, this study sought to: 1) examine whether symptoms of OCD are significantly reduced after inhaling cannabis, 2) examine predictors (gender, dose, cannabis constituents, time) of these symptom changes and 3) explore potential long-term consequences of repeatedly using cannabis to self-medicate for OCD symptoms, including changes in dose and baseline symptom severity over time.
METHOD
Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time. Specifically, data were analyzed from 87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months.
RESULTS
Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis. Higher concentrations of CBD and higher doses predicted larger reductions in compulsions. The number of cannabis use sessions across time predicted changes in intrusions, such that later cannabis use sessions were associated with smaller reductions in intrusions. Baseline symptom severity and dose remained fairly constant over time.
LIMITATIONS
The sample was self-selected, self-identified as having OCD, and there was no placebo control group.
CONCLUSIONS
Inhaled cannabis appears to have short-term beneficial effects on symptoms of OCD. However, tolerance to the effects on intrusions may develop over time.",2020,"RESULTS
Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","['87 individuals self-identifying with OCD who tracked the severity of their intrusions, compulsions, and/or anxiety immediately before and after 1,810 cannabis use sessions spanning a period of 31 months', 'Data were analyzed from the app Strainprint® which provides medical cannabis patients a means of tracking changes in symptoms as a function of different doses and strains of cannabis across time']",['Cannabis'],"['Symptoms of Obsessive-Compulsive Disorder', 'anxiety', 'compulsions']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0813973', 'cui_str': 'Medical Cannabis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}]",,0.034413,"RESULTS
Patients reported a 60% reduction in compulsions, a 49% reduction in intrusions, and a 52% reduction in anxiety from before to after inhaling cannabis.","[{'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Mauzay', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'LaFrance', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Cuttler', 'Affiliation': 'Washington State University, Department of Psychology, Pullman, WA, US. Electronic address: carrie.cuttler@wsu.edu.'}]",Journal of affective disorders,['10.1016/j.jad.2020.09.124']
2192,33053609,Application of ultrasound-guided seminal vesicle radiography combining CT three-dimensional reconstruction technique in transurethral seminal vesiculoscopy.,"For the treatment of ejaculatory duct obstruction, transurethral seminal vesiculoscopy (TSV) is the most common method, but the success rate is much lower than studies that have reported. So we developed a new ultrasound-guided seminal vesicle radiography (UGSVR) combining CT three-dimensional reconstruction (CT-TR) technique to improve the success rate of TSV. Between June 2018 and November 2019, 32 patients were enrolled and randomly assigned to two groups: experimental group (UGSvR combining CT-TR) and control group (standard evaluation). Baseline information, including age, smoking history and body mass index (BMI), was compared preoperatively. Surgical parameters included success rates (SR), surgical time (ST), catheter days (CD), length of hospital stays (HS) and complications were compared between groups. There were no statistically significant differences in baseline data between the two groups (all p > .05). There were no significant differences in the CD, HS and complications between the two groups (all p > .05), but the differences in ST and SR were statistically significant (p < .05). In conclusion, this new technique of UGSvR combining CT-TR was achieving a satisfactory increase in the success rate of TSV, while not increasing the incidence of complications, compared to normal evaluation before TSV operation.",2020,"There were no significant differences in the CD, HS and complications between the two groups (all p > .05), but the differences in ST and SR were statistically significant (p < .05).","['Between June 2018 and November 2019, 32 patients', 'transurethral seminal vesiculoscopy']","['experimental group (UGSvR combining CT-TR) and control group (standard evaluation', 'new ultrasound-guided seminal vesicle radiography (UGSVR) combining CT three-dimensional reconstruction (CT-TR) technique', 'transurethral seminal vesiculoscopy (TSV', 'ultrasound-guided seminal vesicle radiography combining CT three-dimensional reconstruction technique']","['success rates (SR), surgical time (ST), catheter days (CD), length of hospital stays (HS) and complications', 'CD, HS and complications', 'success rate of TSV', 'ST and SR', 'age, smoking history and body mass index (BMI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036628', 'cui_str': 'Seminal vesicle structure'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",32.0,0.0189879,"There were no significant differences in the CD, HS and complications between the two groups (all p > .05), but the differences in ST and SR were statistically significant (p < .05).","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Pang', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Lou', 'Affiliation': 'Department of Ultrasound, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Yayong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Computed Tomography, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Zhenduo', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Zang', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'Department of Pediatrics, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Conghui', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Department of Urology, Xuzhou Clinical School of Xuzhou Medical College, The Affiliated Xuzhou Center Hospital of Nanjing University of Chinese Medicine, Xuzhou Central Hospital, Xuzhou, China.'}]",Andrologia,['10.1111/and.13845']
2193,33065342,Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.,"PURPOSE
In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL).
METHODS
Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs.
RESULTS
Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo.
CONCLUSIONS
In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.",2020,"RESULTS
Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","['Patients', 'reference) group ', 'advanced breast cancer', 'patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer']","['ribociclib plus fulvestrant or placebo plus fulvestrant', 'Ribociclib plus fulvestrant', 'placebo', 'ribociclib plus fulvestrant', 'ribociclib', 'placebo plus fulvestrant']","['worst pain item score', 'progression-free survival (PFS) and overall survival (OS', 'BPI-SF pain severity index score', 'Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire', 'health-related quality of life (HRQOL', 'fatigue and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4087185', 'cui_str': 'Human epidermal growth factor receptor negative'}]","[{'cui': 'C4045494', 'cui_str': 'ribociclib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.436342,"RESULTS
Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany. Electronic address: peter.fasching@uk-erlangen.de.'}, {'ForeName': 'J Thaddeus', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, AR, USA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Chan', 'Affiliation': 'Breast Cancer Research Centre-Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Esteva', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'CHU de Liège, University of Liège, Liège, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pivot', 'Affiliation': 'Institut Régional Du Cancer, Strasbourg, France.'}, {'ForeName': 'Giulia V', 'Initials': 'GV', 'LastName': 'Bianchi', 'Affiliation': 'Fondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, Italy.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martin', 'Affiliation': 'Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chandiwana', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Lanoue', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Ridolfi', 'Affiliation': 'Novartis Pharma SAS, Rueil-Malmaison, France.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Rodriguez Lorenc', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Arnd', 'Initials': 'A', 'LastName': 'Nusch', 'Affiliation': 'Practice for Haematology and Internal Oncology, Velbert, Germany.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.09.008']
2194,33038950,"Effect on mortality of increasing the cutoff blood glucose concentration for initiating hypoglycaemia treatment in severely sick children aged 1 month to 5 years in Malawi (SugarFACT): a pragmatic, randomised controlled trial.","BACKGROUND
Low blood glucose concentrations are common in sick children who present to hospital in low-resource settings and are associated with increased mortality. The cutoff blood glucose concentration for the diagnosis and treatment of hypoglycaemia currently recommended by WHO (2·5 mmol/L) is not evidence-based. We aimed to assess whether increasing the cutoff blood glucose concentration for hypoglycaemia treatment in severely ill children at presentation to hospital improves mortality outcomes.
METHODS
We did a pragmatic, randomised controlled trial at two referral hospitals in Malawi. Severely ill children aged 1 month to 5 years presenting to the emergency department with a capillary blood glucose concentration of between 2·5 mmol/L (3·0 mmol/L in severely malnourished children) and 5·0 mmol/L were randomly assigned (1:1) by a computer-generated randomisation sequence, stratified by study site and severe malnutrition, to receive either an immediate intravenous bolus of 10% dextrose at 5 mL/kg followed by a 24-h maintenance infusion of 10% dextrose at 100 mL/kg for the first 10 kg of bodyweight, 50 mL/kg for the next 10 kg, and 20 mL/kg for each subsequent kg of bodyweight (intervention group) or observation for a minimum of 60 min and standard care (control group). Participants and study personnel were not masked to treatment allocation. The primary outcome was all-cause in-hospital mortality, assessed on an intention-to-treat basis. Safety was also assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02989675.
FINDINGS
Between Dec 5, 2016, and Jan 22, 2019, 10 947 children were screened, of whom 332 were randomly assigned, and 322 were included in the final analysis (n=162 in the control group and n=160 in the intervention group). The study was terminated after an interim analysis at 24% enrolment indicated futility. The median age of participants was 2·3 years (IQR 1·4-3·2), 65 (45%) were female, and the baseline characteristics of participants were similar between the two groups. The number of in-hospital deaths from any cause was 26 (16%) in the control group and 24 (15%) in the intervention group, with an absolute mortality difference of 1·0% (95% CI -6·9 to 9·0). Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
INTERPRETATION
Increasing the cutoff blood glucose concentration for hypoglycaemia treatment in severely sick children in Malawi from 2·5 mmol/L to 5·0 mmol/L did not reduce all-cause in-hospital mortality. Our findings do not support changing the cutoff for dextrose administration, and further research on the optimal management of severely ill children who present to the emergency department with low blood glucose concentrations is warranted.
FUNDING
Swedish Research Council and Stockholm Country Council.",2020,"Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
","['Severely ill children aged 1 month to 5 years presenting to the emergency department with a capillary blood glucose concentration of between 2·5 mmol/L (3·0 mmol/L in severely malnourished children) and 5·0 mmol/L', 'sick children', 'severely sick children', 'two referral hospitals in Malawi', 'Between Dec 5, 2016, and Jan 22, 2019, 10\u2008947 children were screened, of whom 332 were randomly assigned, and 322 were included in the final analysis (n=162 in the control group and n=160 in the intervention group', 'severely ill children', 'severely sick children aged 1 month to 5 years in Malawi (SugarFACT']","['bodyweight (intervention group) or observation for a minimum of 60 min and standard care (control group', 'immediate intravenous bolus of 10% dextrose at 5 mL/kg followed by a 24-h maintenance infusion of 10% dextrose']","['Safety', 'number of in-hospital deaths', 'cutoff blood glucose concentration', 'cause in-hospital mortality, assessed on an intention-to-treat basis', 'mortality of increasing the cutoff blood glucose concentration', 'Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0260101', 'cui_str': 'Sick child'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517712', 'cui_str': '322'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0009791', 'cui_str': 'Consciousness related finding'}]",10947.0,0.295853,"Serious adverse events, including hypoglycaemia, hyperglycaemia, convulsions, reduced consciousness, and death, were reported in 47 (29%) children in the control group and 39 (24%) children in the intervention group.
","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Baker', 'Affiliation': 'Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden; Department of Anaesthesia and Intensive Care, Queen Elizabeth Central Hospital, Blantyre, Malawi; Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi; Perioperative Medicine and Intensive Care, Karolinska University Hospital, Stockholm, Sweden. Electronic address: tim.baker@ki.se.'}, {'ForeName': 'Fatsani', 'Initials': 'F', 'LastName': 'Ngwalangwa', 'Affiliation': 'Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Henderson', 'Initials': 'H', 'LastName': 'Masanjala', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Queen', 'Initials': 'Q', 'LastName': 'Dube', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Langton', 'Affiliation': 'Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi; Department of Paediatrics, College of Medicine, University of Malawi, Blantyre, Malawi.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Marrone', 'Affiliation': 'Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Hildenwall', 'Affiliation': ""Health System and Policy, Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden; Department of Paediatrics, Queen Elizabeth Central Hospital, Blantyre, Malawi; Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden.""}]",The Lancet. Global health,['10.1016/S2214-109X(20)30388-0']
2195,33039205,"Re: Hiten D. Patel, Farzana A. Faisal, Bruce J. Trock, et al. Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial. Eur Urol 2020;78:360-8.",,2020,,[],"['Radical Prostatectomy', 'Pharmacologic Prophylaxis']",['Venous Thromboembolism'],[],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}]",,0.0320834,,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bansal', 'Affiliation': 'Department of Urology, Robotics and Renal Transplant, Max Super Speciality Hospital Saket, New Delhi, India. Electronic address: dramitbansalurology@gmail.com.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Urology, Robotics and Renal Transplant, Max Super Speciality Hospital Saket, New Delhi, India.'}]",European urology,['10.1016/j.eururo.2020.09.040']
2196,33047340,A controlled trial of dissemination and implementation of a cardiovascular risk reduction strategy in small primary care practices.,"OBJECTIVE
To assess the effect of dissemination and implementation of an intervention consisting of practice facilitation and a risk-stratified, population management dashboard on cardiovascular risk reduction for patients at high risk in small, primary care practices.
STUDY SETTING
A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018.
STUDY DESIGN
We performed a stepped-wedge, stratified, cluster randomized trial of a one-year intervention consisting of practice facilitation utilizing quality improvement techniques coupled with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79 years and their unmet treatment opportunities. The primary outcome was change in 10-Year ASCVD Risk score among all patients with a baseline score ≥10 percent from baseline to 3 months postintervention.
DATA COLLECTION/ EXTRACTION METHODS
Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry.
PRINCIPLE FINDINGS
ASCVD risk scores were assessed on 437 556 patients and 146 826 had a calculated 10-year risk ≥10 percent. The mean baseline risk was 23.4 percent (SD ± 12.6 percent). Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4). Models considering calendar time and stepped-wedge controls revealed most of the improvement (4.0 of 6.3 percent) was attributable to the intervention and not secular trends. In multivariate analysis, male gender, age >65 years, low-income (<$40 000), and Black race (P < .001 for all variables) were each associated with greater risk reductions.
CONCLUSION
A risk-stratified, population management dashboard combined with practice facilitation led to substantial reductions of 10-year ASCVD risk for patients at high risk. Similar approaches could lead to effective dissemination and implementation of other new evidence, especially in rural and other under-resourced practices. Registration: ClinicalTrials.Gov 15-0479.",2020,"Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4).","['with a cardiovascular dashboard that included lists of risk-stratified adults, aged 40-79\xa0years and their unmet treatment opportunities', 'Data extracts were securely transferred from practices on a nightly basis from their EHR to the research team registry', 'patients at high risk', 'ASCVD risk scores were assessed on 437\xa0556 patients and 146\xa0826 had a calculated 10-year risk ≥10 percent', 'small primary care practices', 'A total of 219 small primary care practices (≤10 clinicians per site) across North Carolina with primary data collection from electronic health records (EHRs) from the fourth quarter of 2015 through the second quarter of 2018', 'patients at high risk in small, primary care practices']",['practice facilitation utilizing quality improvement techniques coupled'],"['mean baseline risk', '10-Year ASCVD Risk score', 'cardiovascular risk reduction', '10-year ASCVD risk', 'absolute risk reduction']","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",437556.0,0.317543,"Postintervention, the absolute risk reduction was 6.3 percent (95% CI 6.3, 6.4).","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Cykert', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Keyserling', 'Affiliation': 'Division of General Internal Medicine and Clinical Epidemiology, The University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pignone', 'Affiliation': 'Department of Internal Medicine, The Dell Medical School, University of Texas, Austin, Texas, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'DeWalt', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Department of Global Public Health, School of Public Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Justin G', 'Initials': 'JG', 'LastName': 'Trogdon', 'Affiliation': 'Department of Health Policy and Management, The Gillings School of Global Public Health, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wroth', 'Affiliation': 'Community Care of North Carolina, Raleigh, North Carolina, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Halladay', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Mackey', 'Affiliation': 'The North Carolina Area Health Education Centers Program, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Fine', 'Affiliation': 'Department of Biostatistics, The Gillings School of Global Public Health, The University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'In Kim', 'Affiliation': 'Department of Statistics, Eberly College of Science, The Pennsylvania State University, University Park, Pennsylvania, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cene', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Health services research,['10.1111/1475-6773.13571']
2197,33051239,Abemaciclib Reigns Over Breast Cancer in MonarchE.,"Adding abemaciclib to adjuvant endocrine therapy may lead to better outcomes in hormone receptor-positive, HER2-negative, high-risk, early breast cancer. In a phase III trial, the combination improved invasive disease-free survival and distant relapse-free survival compared with endocrine therapy alone. However, a trial of another CDK4/6 inhibitor came to the opposite conclusion.",2020,"In a phase III trial, the combination improved invasive disease-free survival and distant relapse-free survival compared with endocrine therapy alone.",['Abemaciclib Reigns Over Breast Cancer in MonarchE'],[],['invasive disease-free survival and distant relapse-free survival'],"[{'cui': 'C3852841', 'cui_str': 'abemaciclib'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",[],"[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.037244,"In a phase III trial, the combination improved invasive disease-free survival and distant relapse-free survival compared with endocrine therapy alone.",[],Cancer discovery,['10.1158/2159-8290.CD-NB2020-093']
2198,33050362,"Effects of Hyperbaric Oxygen Therapy on Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage after Acute Exercise in Normobaric, Normoxic and Hypobaric, Hypoxic Environments: A Pilot Study.","The purpose of this study was to investigate the effects of hyperbaric oxygen therapy (HBOT) on inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments. Eighteen healthy males were selected and randomly assigned to three groups: exercise in NN conditions (NN group, n = 6), HBOT treatment after exercise in NN conditions (HNN group, n = 6), and HBOT treatment after exercise in HH conditions (HHH group, n = 6). All subjects performed treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition. The HBOT treatments consisted of breathing 100% oxygen at 2.5 atmosphere absolute (ATA) for 60 min. Blood samples were collected before exercise (BE), after exercise (AE), and after HBOT (AH) to examine inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH)). Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p < 0.05). Plasma fibrinogen levels were significantly decreased AH compared to AE in all groups ( p < 0.05), and the HNN group had a significantly lower AH compared to BE ( p < 0.05). Serum IL-6 levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p < 0.05). Serum CK levels were significantly decreased AH compared to AE in the HHH group ( p < 0.05). Serum LDH levels were significantly decreased AH compared to AE in the HNN and HHH groups ( p < 0.05), and the NN and HNN groups had significantly higher AH serum LDH levels compared to BE ( p < 0.05). These results suggest that acute exercise in both the NN and HH environments could induce temporary inflammatory responses and muscle damage, whereas HBOT treatment may be effective in alleviating exercise-induced inflammatory responses and muscle damage.",2020,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p < 0.05).",['Eighteen healthy males'],"['exercise in NN conditions (NN group, n = 6), HBOT treatment after exercise in NN conditions (HNN group, n = 6), and HBOT treatment after exercise in HH conditions (HHH group, n = 6', 'Hyperbaric Oxygen Therapy', 'treadmill running for 60 min at 75-80% maximum heart rate (HRmax) exercise intensity under each condition', 'hyperbaric oxygen therapy (HBOT']","['Serum IL-6 levels', 'AH serum LDH levels', 'Plasma fibrinogen, serum IL-6, CK, and LDH levels', 'Inflammation, Oxidative/Antioxidant Balance, and Muscle Damage', 'inflammation, the oxidative/antioxidant balance, and muscle damage after acute exercise in normobaric, normoxic (NN) and hypobaric, hypoxic (HH) environments', 'Serum LDH levels', 'inflammation (fibrinogen, interleukin-6 [IL-6], and tumor necrosis factor-α (TNF-α)), the oxidative/antioxidant balance (derivatives of reactive oxygen metabolites (d-ROMs) and the biological antioxidant potential (BAP)), and muscle damage (creatine kinase (CK) and lactate dehydrogenase (LDH', 'Serum CK levels', 'Plasma fibrinogen levels']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0268540', 'cui_str': 'Hyperornithinemia-hyperammonemia-homocitrullinuria syndrome'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0856510', 'cui_str': 'Plasma fibrinogen'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]",18.0,0.0181581,"Plasma fibrinogen, serum IL-6, CK, and LDH levels were significantly increased AE compared to BE in all groups ( p < 0.05).","[{'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Jae-Hee', 'Initials': 'JH', 'LastName': 'Min', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}, {'ForeName': 'Yul-Hyo', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Taekwondo, Youngsan University, Yangsan-si 50510, Korea.'}, {'ForeName': 'Hee-Tae', 'Initials': 'HT', 'LastName': 'Roh', 'Affiliation': 'Department of Physical Education, College of Arts and Physical Education, Dong-A University, Busan 49315, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17207377']
2199,33052965,"The cost-effectiveness of MDMA-assisted psychotherapy for the treatment of chronic, treatment-resistant PTSD.","BACKGROUND
Chronic posttraumatic stress disorder (PTSD) is a disabling condition that generates considerable morbidity, mortality, and both medical and indirect social costs. Treatment options are limited. A novel therapy using 3,4-methylenedioxymethamphetamine (MDMA) has shown efficacy in six phase 2 trials. Its cost-effectiveness is unknown.
METHODS AND FINDINGS
To assess the cost-effectiveness of MDMA-assisted psychotherapy (MAP) from the health care payer's perspective, we constructed a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP. In six double-blind phase 2 trials, MAP consisted of a mean of 2.5 90-minute trauma-focused psychotherapy sessions before two 8-hour sessions with MDMA (mean dose of 125 mg), followed by a mean of 3.5 integration sessions for each active session. The control group received an inactive placebo or 25-40 mg. of MDMA, and otherwise followed the same regimen. Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. Efficacy was based on the pooled results of six randomized controlled phase 2 trials with 105 subjects; and a four-year follow-up of 19 subjects. Other inputs were based on published literature and on assumptions when data were unavailable. We modeled results over a 30-year analytic horizon and conducted extensive sensitivity analyses. Our model calculates expected medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Future costs and QALYs were discounted at 3% per year. For 1,000 individuals, MAP generates discounted net savings of $103.2 million over 30 years while accruing 5,553 discounted QALYs, compared to continued standard of care. MAP breaks even on cost at 3.1 years while delivering 918 QALYs. Making the conservative assumption that benefits cease after one year, MAP would accrue net costs of $7.6 million while generating 288 QALYS, or $26,427 per QALY gained.
CONCLUSION
MAP provided to patients with severe or extreme, chronic PTSD appears to be cost-saving while delivering substantial clinical benefit. Third-party payers are likely to save money within three years by covering this form of therapy.",2020,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","['patients with chronic, severe, or extreme, treatment-resistant PTSD with MAP', 'Chronic posttraumatic stress disorder (PTSD', '105 subjects; and a four-year follow-up of 19 subjects']","['MDMA-assisted psychotherapy', '3,4-methylenedioxymethamphetamine', 'MDMA-assisted psychotherapy (MAP', 'inactive placebo']","['medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio', 'Efficacy', 'medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0115471', 'cui_str': 'Methylenedioxymethamphetamine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0346378,"Our model calculates net medical costs, mortality, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.","[{'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Marseille', 'Affiliation': 'Health Strategies International, Oakland, California, United States of America.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Kahn', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Berra', 'Initials': 'B', 'LastName': 'Yazar-Klosinski', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Doblin', 'Affiliation': 'Multidisciplinary Association for Psychedelic Studies (MAPS), Santa Cruz, California, United States of America.'}]",PloS one,['10.1371/journal.pone.0239997']
2200,33055544,"The Effect of Gum Chewing on Abdominal Pain and Nausea Caused by Polyethylene Glycol Solution Used for Intestinal Cleansing Before Colonoscopy: An Endoscopist-Blinded, Randomized Controlled Trial.","Gum chewing is known to have a positive effect on intestinal motility. Most studies have examined its effect on ileus, but there has been no discussion of the effects of polyethylene glycol used in preparation for colonoscopy. The purpose of this study was to determine the effect of gum chewing on abdominal pain and nausea caused by polyethylene glycol solution used for intestinal cleansing before colonoscopy. The study was planned as a single-center, randomized, controlled experimental study. The research sample was determined using power analysis (n = 60). Consecutive patients undergoing colonoscopy were randomized into the experimental and control groups. Patients in the gum group chewed mint-flavored sugar-free gum for 20 minutes every 2 hours until the start of colonoscopy after consuming 2 L of polyethylene glycol solution. Patients in the control group drank only polyethylene glycol solution. Examination of precolonoscopy pain and nausea revealed a statistically significant difference in the gum chewing group (p < .05). Patients using sugar-free gum experienced statistically significant fewer problems after colonoscopy. Gum chewing had a positive effect on abdominal pain and nausea. There are no drawbacks to presolution chewing, and it may be recommended for patients.",2020,Examination of precolonoscopy pain and nausea revealed a statistically significant difference in the gum chewing group (p < .05).,['Consecutive patients undergoing colonoscopy'],"['gum chewing', 'gum group chewed mint-flavored sugar-free gum', 'polyethylene glycol solution', 'Polyethylene Glycol Solution', 'Gum chewing', 'control group drank only polyethylene glycol solution', 'polyethylene glycol', 'Gum Chewing']","['Abdominal Pain and Nausea', 'abdominal pain and nausea', 'precolonoscopy pain and nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",60.0,0.0639332,Examination of precolonoscopy pain and nausea revealed a statistically significant difference in the gum chewing group (p < .05).,"[{'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Aydin Sayilan', 'Affiliation': 'Aylin Aydin Sayilan, PhD, is Assistant Professor, Surgical Nursing Department, The Faculty of Health Sciences, Kırklareli University, Kırklareli, Turkey. Ezgi Seyhan AK, PhD, is Assistant Professor, Surgical Nursing Department, Florence Nightingale Nursing Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey. Zeynep Temiz, PhD, is Assistant Professor, Surgical Nursing Department, Faculty of Health Sciences, Artvin Coruh University, Artvin, Turkey. Seher Deniz Öztekin, PhD, is Prof. Dr., Surgical Nursing Department, Florence Nightingale Nursing Faculty, Istanbul University-Cerrahpasa, Istanbul, Turkey. Sevgi Colak, RN, is Nurse, Endoscopy Unit, Luleburgaz State Hospital, Kırklareli, Turkey. Okay Pirti, is Operator Dr., Endoscopy Unit, Luleburgaz State Hospital, Kırklareli, Turkey.'}, {'ForeName': 'Ezgi', 'Initials': 'E', 'LastName': 'Seyhan Ak', 'Affiliation': ''}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Temiz', 'Affiliation': ''}, {'ForeName': 'Seher Deniz', 'Initials': 'SD', 'LastName': 'Öztekin', 'Affiliation': ''}, {'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Colak', 'Affiliation': ''}, {'ForeName': 'Okay', 'Initials': 'O', 'LastName': 'Pirti', 'Affiliation': ''}]",Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates,['10.1097/SGA.0000000000000497']
2201,33058886,Comparing a conventional and a spring-and-loop with clip traction method of endoscopic submucosal dissection for superficial gastric neoplasms: a randomized controlled trial (with videos).,"BACKGROUND AND AIMS
Several traction methods have sought to overcome the technical difficulties of endoscopic submucosal dissection (ESD). However, traction direction has remained limited in most of these methods, with lack of clarity about the optimal method and traction direction for gastric ESD. A spring-and-loop with clip (SLC) has been developed as a multidirectional traction device. Here, we investigated whether SLC traction-assisted ESD (SLC-ESD) improved procedure-related outcomes compared with conventional ESD (C-ESD) among patients with superficial gastric neoplasms.
METHODS
This single-center randomized controlled trial included patients with superficial gastric neoplasms undergoing SLC-ESD or C-ESD between October 2018 and December 2019. Using the multidirectional traction function, we set traction vertical to the gastric wall for SLC-ESD. The primary outcome was the median procedure time for gastric ESD.
RESULTS
The SLC-ESD and C-ESD groups comprised 40 patients each, and all the enrolled patients underwent the assigned treatment. The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = .005). SLC had a mean attachment time of 1.82 minutes. En bloc resection was achieved without perforation in all the patients in both groups.
CONCLUSIONS
Our findings suggest that SLC-ESD reduces gastric ESD procedure time without increasing the risk of perforation and that the vertical direction to the gastric wall is the appropriate traction direction for gastric ESD. (Clinical trial registration number: UMIN 000034533.).",2020,The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = 0.005).,"['patients with superficial gastric neoplasms undergoing SLC-ESD or C-ESD between October 2018 and December 2019', 'patients with superficial gastric neoplasms', 'superficial gastric neoplasms']","['SLC traction-assisted ESD (SLC-ESD', 'conventional and a spring-and-loop with clip traction method of endoscopic submucosal dissection', 'SLC-ESD', 'A spring-and-loop with clip (SLC', 'SLC', 'conventional ESD (C-ESD']","['mean attachment time', 'median procedure time for gastric ESD', 'median ESD procedure time', 'gastric ESD procedure time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]","[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1562800', 'cui_str': 'Soft tissue traction technique'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}]",,0.06134,The median ESD procedure time was significantly shorter in the SLC-ESD group (29.1 minutes) than in the C-ESD group (52.6 minutes; P = 0.005).,"[{'ForeName': 'Mitsuru', 'Initials': 'M', 'LastName': 'Nagata', 'Affiliation': 'Department of Endoscopy, Shonan Fujisawa Tokushukai Hospital, Fujisawa-shi, Kanagawa, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Fujikawa', 'Affiliation': 'Center for Digestive and Hepato-Biliary-Pancreatic disease, Shonan Fujisawa Tokushukai Hospital, Fujisawa-shi, Kanagawa, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Munakata', 'Affiliation': 'Center for Digestive and Hepato-Biliary-Pancreatic disease, Shonan Fujisawa Tokushukai Hospital, Fujisawa-shi, Kanagawa, Japan.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.09.049']
2202,33058957,"Nutritional adequacy of very low- and high-carbohydrate, low saturated fat diets in adults with type 2 diabetes: A secondary analysis of a 2-year randomised controlled trial.","BACKGROUND
Growing evidence supports use of very low-carbohydrate (LC) diets for glycaemic control in type 2 diabetes. However, limited data on the micronutrient adequacy of LC diets exist.
OBJECTIVE
This study compared the long-term effects of a very low-carbohydrate, high unsaturated/low saturated fat (LC) diet to a high-carbohydrate, low-fat (HC) diet on micronutrient biomarkers in adults with obesity and type 2 diabetes.
METHODS
115 adults with type 2 diabetes (mean[SD]; BMI:34.6[4.3]kg/m 2 , age:58[7]yrs, HbA1c:7.3[1.1]%, 56[12]mmol/mol) were randomized to one of two planned, nutritionally-replete, energy-matched, hypocaloric diets (500-1000 kcal/day deficit): (1) LC:14% energy carbohydrate, 28%protein, 58%fat[<10% saturated fat]) or (2) HC:53%carbohydrate, 17%protein, 30%fat [<10%saturated fat]) for 2 years. Nutritional biomarkers- folate, β-carotene, vitamin B12, D, E, copper, zinc, selenium, calcium, magnesium, sodium, potassium, iron, ferritin, transferrin and transferrin saturation were measured in fasting blood at baseline, 24, 52 and 104 weeks.
RESULTS
61 participants completed the study with similar dropouts in each group (P = 0.40). For all biomarkers assessed, there were no differential response between groups overtime (P ≥ 0.17 time × diet interaction). Mean vitamin and mineral levels remained within normal (laboratory-specific) reference ranges without any reported cases of clinical deficiencies.
CONCLUSION
In free-living individuals with type 2 diabetes, nutrition biomarkers within normal ranges at baseline did not change significantly after 2 years on a prescribed LC or HC diet. These results demonstrate the feasibility of delivering a nutritionally replete LC diet and the importance of considering nutritional factors in planning LC diets that have strong public health relevance to the dietary management of type 2 diabetes.
TRIAL REGISTRATION
http://www.anzctr.org.au/, ANZCTR No. ACTRN12612000369820.",2020,"For all biomarkers assessed, there were no differential response between groups overtime (P≥0.17 time x diet interaction).","['115 adults with type 2 diabetes (mean[SD', 'type 2 diabetes', 'adults with obesity and type 2 diabetes', 'adults with type 2 diabetes', '61 participants completed the study with similar dropouts in each group (P=0.40']","['very low-carbohydrate, high unsaturated/low saturated fat (LC) diet to a high-carbohydrate, low-fat (HC) diet', 'nutritionally-replete, energy-matched, hypocaloric diets (500-1000kcal/day deficit): (1) LC:14% energy carbohydrate, 28%protein, 58%fat[<10% saturated fat]) or (2) HC:53%carbohydrate, 17%protein, 30%fat [<10%saturated fat', 'low-carbohydrate (LC) diets', 'very low- and high-carbohydrate, low saturated fat diets']","['Nutritional biomarkers- folate, β-carotene, vitamin B12, D, E, copper, zinc, selenium, calcium, magnesium, sodium, potassium, iron, ferritin, transferrin and transferrin saturation', 'Mean vitamin and mineral levels']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522535', 'cui_str': 'Unsaturated'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0007269', 'cui_str': 'Carotene'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0040679', 'cui_str': 'Transferrin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",115.0,0.0668126,"For all biomarkers assessed, there were no differential response between groups overtime (P≥0.17 time x diet interaction).","[{'ForeName': 'Jeannie', 'Initials': 'J', 'LastName': 'Tay', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia; Discipline of Medicine, University of Adelaide, Adelaide, Australia; Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), Singapore. Electronic address: jeannie_tay@sics.a-star.edu.sg.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Manny', 'Initials': 'M', 'LastName': 'Noakes', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Adelaide, Australia.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Buckley', 'Affiliation': 'Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Wittert', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Brinkworth', 'Affiliation': 'Commonwealth Scientific and Industrial Research Organisation (CSIRO) - Health and Biosecurity, Sydney, Australia.'}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108501']
2203,33263418,MAHOGANY: margetuximab combination in HER2 + unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma.,"Standard-of-care, first-line therapy for patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction adenocarcinoma is chemotherapy plus trastuzumab, a monoclonal antibody (mAb) targeting HER2. Margetuximab is an Fc-optimized mAb that binds HER2. Retifanlimab, a humanized IgG4 mAb, binds to PD-1 and blocks its interaction with PD-L1/2. Tebotelimab, an IgG4κ bispecific DART ® molecule, binds PD-1 and lymphocyte activation gene 3 concomitantly, disrupting these nonredundant inhibitory pathways to further restore exhausted T-cell function. Here, we describe the design and rationale of the randomized, open-label, Phase II/III MAHOGANY trial evaluating margetuximab plus retifanlimab with/without chemotherapy and margetuximab plus tebotelimab with chemotherapy in first-line unresectable metastatic/locally advanced gastroesophageal junction adenocarcinoma. Primary end points include objective response rate, overall survival and safety/tolerability. Clinical trial registration: NCT04082364 (ClinicalTrials.gov).",2020,"Tebotelimab, an IgG4κ bispecific DART ® molecule, binds PD-1 and lymphocyte activation gene","['first-line unresectable metastatic/locally advanced gastroesophageal junction adenocarcinoma', 'patients with advanced human epidermal growth factor receptor 2 (HER2)-positive gastric/gastroesophageal junction adenocarcinoma\xa0is', 'unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma']","['margetuximab plus retifanlimab with/without chemotherapy and margetuximab plus tebotelimab with chemotherapy', 'margetuximab combination in HER2 ', 'chemotherapy plus trastuzumab']","['objective response rate, overall survival\xa0and safety/tolerability']","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}]","[{'cui': 'C4053695', 'cui_str': 'margetuximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0624175,"Tebotelimab, an IgG4κ bispecific DART ® molecule, binds PD-1 and lymphocyte activation gene","[{'ForeName': 'Daniel Vt', 'Initials': 'DV', 'LastName': 'Catenacci', 'Affiliation': 'Department of Medicine, Section of Hematology & Oncology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Minori', 'Initials': 'M', 'LastName': 'Rosales', 'Affiliation': 'Clinical Research, MacroGenics, Inc., Rockville, MD 20850, USA.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Yonsei Cancer Center, University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'H Yoon', 'Affiliation': 'Mayo Clinic Cancer Center, Rochester, MN 55905, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Peking University Cancer Hospital & Institute, Beijing 100142, China.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'University Medical Center Mainz, Mainz 55131, Germany.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}]","Future oncology (London, England)",['10.2217/fon-2020-1007']
2204,33263359,Interventions for convergence insufficiency: a network meta-analysis.,"BACKGROUND
Convergence insufficiency is a common binocular vision disorder in which the eyes have a strong tendency to drift outward (exophoria) with difficulty turning the eyes inward when reading or doing close work.
OBJECTIVES
To assess the comparative effectiveness and relative ranking of non-surgical interventions for convergence insufficiency through a systematic review and network meta-analysis (NMA).
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, PubMed and three trials registers up to 20 September 2019.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) examining any form of non-surgical intervention versus placebo, no treatment, sham treatment, or other non-surgical interventions. Participants were children and adults with symptomatic convergence insufficiency.
DATA COLLECTION AND ANALYSIS
We followed standard Cochrane methodology. We performed NMAs separately for children and adults.
MAIN RESULTS
We included 12 trials (six in children and six in adults) with a total of 1289 participants. Trials evaluated seven interventions: 1) office-based vergence/accommodative therapy with home reinforcement; 2) home-based pencil/target push-ups; 3) home-based computer vergence/accommodative therapy; 4) office-based vergence/accommodative therapy alone; 5) placebo vergence/accommodative therapy or other placebo intervention; 6) prism reading glasses; and 7) placebo reading glasses. Six RCTs in the pediatric population randomized 968 participants. Of these, the Convergence Insufficiency Treatment Trial (CITT) Investigator Group completed four RCTs with 737 participants. All four CITT RCTs were rated at low risk of bias. Diagnostic criteria and outcome measures were identical or similar among these trials. The four CITT RCTs contributed data to the pediatric NMA, incorporating interventions 1, 2, 3 and 5. When treatment success was defined by a composite outcome requiring both clinical measures of convergence to be normal, and also show a pre-specified magnitude of improvement, we found high-certainty evidence that office-based vergence/accommodative therapy with home reinforcement increases the chance of a successful outcome, compared with home-based computer vergence/accommodative therapy (risk ratio (RR) 1.96, 95% confidence interval (CI) 1.32 to 2.94), home-based pencil/target push-ups (RR 2.86, 95% CI 1.82 to 4.35); and placebo (RR 3.04, 95% CI 2.32 to 3.98). However, there may be no evidence of any treatment difference between home-based computer vergence/accommodative therapy and home-based pencil/target push-ups (RR 1.44, 95% CI 0.93 to 2.24; low-certainty evidence), or between either of the two home-based therapies and placebo therapy, for the outcome of treatment success. When treatment success was defined as the composite convergence and symptom success outcome, we found moderate-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement were 5.12 (95% CI 2.01 to 13.07) times more likely to achieve treatment success than those who received placebo therapy. We found low-certainty evidence that participants who received office-based vergence/accommodative therapy with home reinforcement might be 4.41 (95% CI 1.26 to 15.38) times more likely to achieve treatment success than those who received home-based pencil push-ups, and 4.65 (95% CI 1.23 to 17.54) times more likely than those who received home-based computer vergence/accommodative therapy. There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy. One RCT evaluated the effectiveness of base-in prism reading glasses in children. When base-in prism reading glasses were compared with placebo reading glasses, investigators found no evidence of a difference in the three outcome measures of near point convergence (NPC), positive fusional vergence (PFV), or symptom scores measured by the Convergence Insufficiency Symptom Survey (CISS). Six RCTs in the adult population randomized 321 participants. We rated only one RCT at low risk of bias. Because not all studies of adults included composite success data, we could not conduct NMAs for treatment success. We thus were limited to comparing the mean difference (MD) between interventions for improving NPC, PFV, and CISS scores individually using data from three RCTs (107 participants; interventions 1, 2, 4 and 5). Compared with placebo treatment, office-based vergence accommodative therapy was relatively more effective in improving PFV (MD 16.73, 95% CI 6.96 to 26.60), but there was no evidence of a difference for NPC or the CISS score. There was no evidence of difference for any other comparisons for any outcomes. One trial evaluated base-in prism glasses prescribed for near-work activities and found that the prism glasses group had fewer symptoms compared with the placebo glasses group at three months (MD -8.9, 95% CI -11.6 to -6.3). The trial found no evidence of a difference with this intervention in NPC or PFV. No adverse effects related to study treatments were reported for any of the included studies. Excellent adherence was reported for office-based vergence/accommodative therapy (96.6% or higher) in two trials. Reported adherence with home-based therapy was less consistent, with one study reporting decreasing adherence over time (weeks 7 to 12) and lower completion rates with home-based pencil/target push-ups.
AUTHORS' CONCLUSIONS
Current research suggests that office-based vergence/accommodative therapy with home reinforcement is more effective than home-based pencil/target push-ups or home-based computer vergence/accommodative therapy for children. In adults, evidence of the effectiveness of various non-surgical interventions is less clear.",2020,"There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy.","['pediatric population randomized 968 participants', 'children', 'adult population randomized 321 participants', '12 trials (six in children and six in adults) with a total of 1289 participants', 'children and adults', 'Embase, PubMed and three trials registers up to 20 September 2019', 'Participants were children and adults with symptomatic convergence insufficiency']","['placebo, no treatment, sham treatment, or other non-surgical interventions', 'office-based vergence/accommodative therapy with home reinforcement; 2) home-based pencil/target push-ups; 3) home-based computer vergence/accommodative therapy; 4) office-based vergence/accommodative therapy alone; 5) placebo vergence/accommodative therapy or other placebo intervention; 6) prism reading glasses; and 7) placebo reading glasses', 'placebo']","['near point convergence (NPC), positive fusional vergence (PFV), or symptom scores', 'adverse effects', 'NPC, PFV, and CISS scores', 'Excellent adherence', 'PFV', 'chance of a successful outcome']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0271379', 'cui_str': 'Convergence insufficiency'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0423037', 'cui_str': 'Convergence near point'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",968.0,0.383363,"There was no evidence of any treatment difference between home-based pencil push-ups and home-based computer vergence/accommodative therapy, or between either of the two home-based therapies and placebo therapy.","[{'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Scheiman', 'Affiliation': 'Salus University, Elkins Park, Pennsylvania, USA.'}, {'ForeName': 'Marjean T', 'Initials': 'MT', 'LastName': 'Kulp', 'Affiliation': 'College of Optometry, The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Cotter', 'Affiliation': 'Southern California College of Optometry, Fullerton, California, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Lawrenson', 'Affiliation': 'Centre for Applied Vision Research, School of Health Sciences, City University of London, London, UK.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Tianjing', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, University of Colorado Denver Anschutz Medical Campus, Aurora, CO, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD006768.pub3']
2205,33263357,Emergency Physicians and Personal Narratives Improve the Perceived Effectiveness of COVID-19 Public Health Recommendations on Social Media: A Randomized Experiment.,"BACKGROUND
Containment of the coronavirus disease 2019 (COVID-19) pandemic requires the public to change behavior under social distancing mandates. Social media are important information dissemination platforms that can augment traditional channels communicating public health recommendations. The objective of the study is to assess the effectiveness of COVID-19 public health messaging on Twitter when delivered by emergency physicians and containing personal narratives.
METHODS
On April 30, 2020, we randomly assigned 2007 U.S. adults to an online survey using a 2x2 factorial design. Participants rated 1 of 4 simulated Twitter posts varied by messenger type (emergency physician vs federal official) and content (personal narrative vs impersonal guidance). Main outcomes were: perceived message effectiveness (35-point scale); perceived attitude effectiveness (15-point scale); likelihood to share Tweets (7-point scale); and writing a letter to their governor to continue COVID-19 restrictions (write letter or none).
RESULTS
The physician/personal message had the strongest effect and significantly improved all main messaging outcomes except for letter-writing. Unadjusted mean differences between physician/personal and federal/impersonal were: perceived messaging effectiveness (3.2 [95%CI, 2.4-4.0]); perceived attitude effectiveness (1.3 [95%CI, 0.8-1.7]); likelihood to share (0.4 [95%CI, 0.15-0.7]). For letter-writing, physician/ personal made no significant impact compared to federal/ impersonal (odds ratio 1.14 [95%CI, 0.89-1.46]).
CONCLUSIONS
Emergency physicians sharing personal narratives on Twitter are perceived to be more effective at communicating COVID-19 health recommendations compared to federal officials sharing impersonal guidance.",2020,"For letter-writing, physician/ personal made no significant impact compared to federal/ impersonal (odds ratio 1.14 [95%CI, 0.89-1.46]).
",['Participants rated 1 of 4 simulated Twitter posts varied by messenger type (emergency physician vs federal official) and content (personal narrative vs impersonal guidance'],['COVID-19 public health messaging'],"['perceived message effectiveness (35-point scale); perceived attitude effectiveness (15-point scale); likelihood to share Tweets (7-point scale); and writing a letter to their governor to continue COVID-19 restrictions (write letter or none', 'attitude effectiveness', 'messaging effectiveness']","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0335218', 'cui_str': 'Messenger'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0600664', 'cui_str': 'Personal Narratives'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0456148', 'cui_str': 'Null'}]",,0.0716554,"For letter-writing, physician/ personal made no significant impact compared to federal/ impersonal (odds ratio 1.14 [95%CI, 0.89-1.46]).
","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Solnick', 'Affiliation': 'U-M National Clinical Scholars Program, Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chao', 'Affiliation': 'U-M National Clinical Scholars Program, Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Ross', 'Affiliation': 'University of Michigan, School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Gordon T', 'Initials': 'GT', 'LastName': 'Kraft-Todd', 'Affiliation': 'Department of Psychology, Boston College, Chestnut Hill, Massachusetts.'}, {'ForeName': 'Keith E', 'Initials': 'KE', 'LastName': 'Kocher', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, University of Michigan, Ann Arbor, MI.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14188']
2206,33263352,Music tuned to 432 Hz versus music tuned to 440 Hz for improving sleep in patients with spinal cord injuries: a double-blind cross-over pilot study.,"BACKGROUND AND AIM OF THE WORK
Among people with spinal cord injuries, sleep disorders are considered one of the top well-being priorities. Some studies suggest that listening to music promotes sleep and improves its quality. These studies usually used music standardised at the frequency of 440 Hz. The aim of the present study is to compare the effects of listening to music tuned to 440 Hz and music tuned to 432 Hz on sleep in patients with spinal cord injuries.
METHODS
Double-blind cross-over pilot study in a single Italian Spinal Unit. 12 patients with spinal injuries were provided with mp3 players loaded with their favourite music tuned to 440 Hz or 432 Hz. They were invited to listen to music for 30 minutes each day, in the two periods of the study. ""Sleep Scale for Medical Study"" modified for this study, and the ""Perceived Stress Scale"" were chosen.
RESULTS
The participants were eight males (mean age =58.12, SD ±13.62), and four females (mean age =56.25, SD ±14.17). Five were quadriplegics and seven were paraplegics. Listening times and wash-out periods were variable. The stress decreased, but not significantly, with listening to music at both frequencies. After listening to music at 432 Hz there was a significant improvement in sleep scores (+3.6, p=0.02), while there was no improvement in sleep scores listening to music at 440 Hz (-1.50, p=0.34).
CONCLUSIONS
The results suggest that further studies on music interventions at 432 Hz should be performed. It is advisable to increase sample sizes and use a range of different research methods.",2020,"After listening to music at 432 Hz there was a significant improvement in sleep scores (+3.6, p=0.02), while there was no improvement in sleep scores listening to music at 440 Hz (-1.50, p=0.34).
","['participants were eight males (mean age =58.12, SD ±13.62), and four females (mean age =56.25, SD ±14.17', '12 patients with spinal injuries', 'people with spinal cord injuries, sleep disorders', 'patients with spinal cord injuries', 'Double-blind cross-over pilot study in a single Italian Spinal Unit']","['listening to music tuned to 440 Hz and music tuned to 432 Hz', 'Music tuned to 432 Hz versus music tuned to 440 Hz', 'mp3 players loaded with their favourite music tuned to 440 Hz or 432 Hz']","['sleep scores', 'Sleep Scale', 'sleep scores listening']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037937', 'cui_str': 'Spinal injury'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C2350433', 'cui_str': 'MP3-Player'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}]",12.0,0.162832,"After listening to music at 432 Hz there was a significant improvement in sleep scores (+3.6, p=0.02), while there was no improvement in sleep scores listening to music at 440 Hz (-1.50, p=0.34).
","[{'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Calamassi', 'Affiliation': 'University and Continuing Education Center, AUSL Toscana Centro - Empoli - Florence (Italy).. diletta.calamassi@gmail.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Lucicesare', 'Affiliation': 'Emergency Department, San Giuseppe Hospital - Empoli - Florence, Italy. alessia.lucicesare@stud.unifi.it.'}, {'ForeName': 'Gian Paolo', 'Initials': 'GP', 'LastName': 'Pomponi', 'Affiliation': 'Indipendent musician and sound engineer, Italy.. gp.pomponi@gp432.com.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bambi', 'Affiliation': 'Medical and Surgical Intensive Care Unit, Careggi University Hospital, Florence, Italy. stefano.bambi@unifi.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i12-S.10755']
2207,33261981,Trans-oral endoscopic assisted radio-frequency for adenoid ablation; A randomized prospective comparative clinical study.,"OBJECTIVE
This study compared the efficacy and safety of conventional adenoidectomy using a curette and the Radio-frequency (RF) adenoid ablation using endoscope via the trans-oral technique.
METHODS
A randomized prospective comparative study was conducted in a tertiary care hospital. The study included 80 patients with a diagnosis of adenoid hypertrophy, which was confirmed by X-ray of a lateral view of the skull. The patients were submitted into two groups 40 for each: curettage group and Radiofrequency group. Patients with bleeding diathesis, congenital anomalies, previous adenoidectomy, and morbid illness were excluded from the study. We evaluated the time consumption, the adenoid tissue remnant by the endoscope, blood loss, and clinical correlations like pain by Visual Analog Scale, halitosis, and secondary bleeding in both study groups.
RESULTS
Intra-operative blood loss was 20-40 ml in the Radio-frequency (RF) group, but in the curettage group was 36 - 55 ml. Post-operative pain in the (RF) group was lower than the curettage group. Secondary bleeding was reported mostly in the curettage group (15%). The duration of the operation in (RF) group was relatively long. Halitosis decreased mainly after curettage adenoidectomy.
CONCLUSION
The endoscopic radio-frequency adenoid ablation surpassed the conventional method. We encourage using Radio-frequency in adenoid surgery as a replacement for the traditional method.",2020,Post-operative pain in the (RF) group was lower than the curettage group.,"['80 patients with a diagnosis of adenoid hypertrophy, which was confirmed by X-ray of a lateral view of the skull', 'Patients with bleeding diathesis, congenital anomalies, previous adenoidectomy, and morbid illness were excluded from the study']","['conventional adenoidectomy using a curette and the Radio-frequency (RF) adenoid ablation using endoscope via the trans-oral technique', 'curettage group and Radiofrequency group', 'Trans-oral endoscopic assisted radio-frequency for adenoid ablation']","['Intra-operative blood loss', 'efficacy and safety', 'Secondary bleeding', 'time consumption, the adenoid tissue remnant by the endoscope, blood loss, and clinical correlations like pain by Visual Analog Scale, halitosis, and secondary bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149825', 'cui_str': 'Hypertrophy of adenoids'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001425', 'cui_str': 'Adenoid excision'}, {'cui': 'C0180236', 'cui_str': 'Curette'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001428', 'cui_str': 'Adenoidal structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}]",80.0,0.0231956,Post-operative pain in the (RF) group was lower than the curettage group.,"[{'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Elzayat', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Kafr Elsheikh University, Egypt.'}, {'ForeName': 'Hossam', 'Initials': 'H', 'LastName': 'Elsherif', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Tanta University, Egypt.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Aouf', 'Affiliation': 'Otorhinolaryngology, Faculty of Medicine, Kafr Elsheikh University, Egypt. Electronic address: mohammad.aouf.ent@gmail.com.'}]","Auris, nasus, larynx",['10.1016/j.anl.2020.11.010']
2208,33261932,"Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) Among Patients with Treatment Resistant Depression in Two, Randomized, Double-blind, Active-controlled Trials of Esketamine Nasal Spray Combined With a New Oral Antidepressant.","BACKGROUND
Patients with major depressive disorder who do not respond to ≥2 different pharmacological treatments within the current depressive episode are considered to have treatment resistant depression (TRD). This analysis determined meaningful change thresholds (MCT) of the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS) using anchor-based methods and compared proportions of meaningful changes in patients with TRD across treatment groups from two Phase 3 trials for esketamine nasal spray (SPRAVATO TM ).
METHODS
Data from two Phase 3 trials in patients with TRD, TRANSFORM-1 and -2, were used in this analysis. The MCTs for the PHQ-9 and MADRS were derived using a clinician global impression of severity anchor. Blinded probability density functions displayed score distributions between anchor categories. Proportions of meaningful response were compared between treatment groups using chi-square tests supported by unblinded cumulative distribution functions of change scores.
RESULTS
Baseline scores were similar for the PHQ-9 and MADRS between the esketamine/antidepressant (AD) and AD/placebo groups. The most appropriate MCT on the PHQ-9 was -6 points. By Day 28, 86.5% of patients reached or exceeded the PHQ-9 MCT in the esketamine/AD group compared to 70% in the placebo/AD group. The most appropriate MCT for the MADRS was -10 points. By Day 28, 78.2% of patients reached or exceeded the MADRS MCT in the esketamine/AD group compared to 65.0% in the placebo/AD group.
CONCLUSIONS
Individual-level meaningful change for the PHQ-9 and MADRS was effectively quantified using a clinical anchor to interpret efficacy from patients with TRD and their treating clinicians.",2020,"By Day 28, 86.5% of patients reached or exceeded the PHQ-9","['Patients with major depressive disorder who do not respond to ≥2 different pharmacological treatments within the current depressive episode are considered to have treatment resistant depression (TRD', 'Patients with Treatment Resistant Depression', 'Data from two Phase 3 trials in patients with TRD, TRANSFORM-1 and -2']","['Esketamine Nasal Spray Combined With a New Oral Antidepressant', 'MCT', 'PHQ-9']","['Meaningful Change in Depression Symptoms Assessed with the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS', 'MADRS MCT', 'meaningful change thresholds (MCT) of the Patient Health Questionnaire (PHQ-9) and Montgomery-Åsberg Depression Rating Scale (MADRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",,0.192728,"By Day 28, 86.5% of patients reached or exceeded the PHQ-9","[{'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Hudgens', 'Affiliation': 'Clinical Outcomes Solutions, Tucson, AZ, US. Electronic address: stacie.hudgens@clinoutsolutions.com.'}, {'ForeName': 'Lysbeth', 'Initials': 'L', 'LastName': 'Floden', 'Affiliation': 'Clinical Outcomes Solutions, Tucson, AZ, US.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Blackowicz', 'Affiliation': 'Clinical Outcomes Solutions, Tucson, AZ, US.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Jamieson', 'Affiliation': 'Janssen Research and Development LLC, Milpitas, CA, US.'}, {'ForeName': 'Vanina', 'Initials': 'V', 'LastName': 'Popova', 'Affiliation': 'Janssen Research and Development LLC, Beerse, BE.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Fedgchin', 'Affiliation': 'Janssen Research and Development LLC, Titusville, NJ, US.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Janssen Research and Development LLC, San Diego, CA, US.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Janssen Research and Development LLC, Spring House, PA, US.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Lane', 'Affiliation': 'Janssen Research and Development LLC, Titusville, NJ, US.'}, {'ForeName': 'Jaskaran', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Janssen Research and Development LLC, San Diego, CA, US.'}]",Journal of affective disorders,['10.1016/j.jad.2020.11.066']
2209,33261915,Support for a nicotine reduction policy among participants enrolled in a 20-week trial of very low nicotine content cigarettes.,"INTRODUCTION
The Food and Drug Administration is considering a policy to drastically reduce the allowable nicotine content of cigarettes. The current study examined whether the policy implementation approach, i.e., either immediately reducing nicotine content to very low levels or gradually reducing nicotine content over an extended period, influences policy support among people who smoke cigarettes.
METHODS
Adults who smoked daily were randomly assigned (double-blind) to an immediate nicotine reduction condition (0.4 mg/g nicotine cigarettes), a gradual nicotine reduction condition (15.5 to 0.4 mg/g), or a control condition (15.5 mg/g) for 20 weeks. Participants were asked if they would ""support or oppose a law that reduced the amount of nicotine in cigarettes, to make cigarettes less addictive."" Logistic regression analyses assessed if policy support was affected by treatment condition, demographic covariates, interest in quitting, and subjective cigarette effects.
RESULTS
At Week 20 (N = 957 completers), 60.4% of participants supported the policy, 17.4% opposed, and 22.2% responded ""Don't know."" Policy support did not differ by treatment condition. Support was greater among those interested in quitting (OR = 3.37, 95% CI = 2.49, 4.55). Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18-24 (OR = 0.53, 95% CI = 0.28, 0.99). No other covariates were associated with policy support.
CONCLUSIONS
The majority of participants supported a nicotine reduction policy. The implementation approach, immediate or gradual reduction, did not affect policy support. Participants interested in quitting smoking were more likely to support a nicotine reduction policy.",2020,"Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18-24 (OR = 0.53, 95% CI = 0.28, 0.99).","['participants enrolled in a 20-week trial of very low nicotine content cigarettes', 'people who smoke cigarettes', 'Adults who smoked daily']","['gradual nicotine reduction condition', 'immediate nicotine reduction condition (0.4\xa0mg/g nicotine cigarettes']","['demographic covariates, interest in quitting, and subjective cigarette effects', 'quitting smoking']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]",,0.0512707,"Support was lower among males (OR = 0.49, 95% CI = 0.37, 0.67), those with greater dependence scores (OR = 0.92, 95% CI = 0.86, 0.99) and participants aged 18-24 (OR = 0.53, 95% CI = 0.28, 0.99).","[{'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Denlinger-Apte', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA. Electronic address: rdenling@wakehealth.edu.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, School of Public Health and Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: koopm007@umn.edu.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA. Electronic address: jennifer_tidey@brown.edu.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Division of Biostatistics, School of Public Health and Masonic Cancer Center, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: luox0054@umn.edu.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Hollings Cancer Center and Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC 29425, USA. Electronic address: smithtra@musc.edu.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Pacek', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC 27705, USA. Electronic address: lauren.pacek@duke.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Joseph McClernon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC 27705, USA.'}, {'ForeName': 'Joni A', 'Initials': 'JA', 'LastName': 'Jensen', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: jense010@umn.edu.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Colby', 'Affiliation': 'Department Psychiatry and Human Behavior, Brown University, Providence, RI 02912, USA. Electronic address: suzanne_colby@brown.edu.'}, {'ForeName': 'Herbert H', 'Initials': 'HH', 'LastName': 'Severson', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA. Electronic address: herb@ori.org.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Donny', 'Affiliation': 'Department of Physiology and Pharmacology, Wake Forest School of Medicine, Winston-Salem, NC 27157, USA. Electronic address: edonny@wakehealth.edu.'}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Hatsukami', 'Affiliation': 'Masonic Cancer Center and Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN 55455, USA. Electronic address: hatsu001@umn.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106727']
2210,33261825,"Re: Intraoperative application of inactivated Pseudomonas aeruginosa in patients undergoing lateral neck dissection for metastatic thyroid cancer: A randomized, parallel group, placebo-controlled trial.",,2020,,['patients undergoing lateral neck dissection for metastatic thyroid cancer'],"['placebo', 'inactivated Pseudomonas aeruginosa']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C1096666', 'cui_str': 'Thyroid cancer metastatic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033809', 'cui_str': 'Pseudomonas aeruginosa'}]",[],,0.376801,,"[{'ForeName': 'Smriti', 'Initials': 'S', 'LastName': 'Panda', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi. Electronic address: smriti.panda.87@gmail.com.'}, {'ForeName': 'Chirom Amit', 'Initials': 'CA', 'LastName': 'Singh', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi.'}, {'ForeName': 'Pirabu', 'Initials': 'P', 'LastName': 'Sakthivel', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Goel', 'Affiliation': 'Department of Otorhinolaryngology and Head and Neck Surgery, All India Institute of Medical Sciences, New Delhi.'}]",Surgery,['10.1016/j.surg.2020.10.016']
2211,33261700,Group transdiagnostic cognitive-behavior therapy for anxiety disorders: a pragmatic randomized clinical trial.,"BACKGROUND
Transdiagnostic group cognitive-behavioral therapy (tCBT) is a delivery model that could help overcome barriers to large-scale implementation of evidence-based psychotherapy for anxiety disorders. The aim of this study was to assess the effectiveness of combining group tCBT with treatment-as-usual (TAU), compared to TAU, for the treatment of anxiety disorders in community-based mental health care.
METHODS
In a multicenter single-blind, two-arm pragmatic superiority randomized trial, we recruited participants aged 18-65 who met DSM-5 criteria for principal diagnoses of generalized anxiety disorder, social anxiety disorder, panic disorder, or agoraphobia. Group tCBT consisted of 12 weekly 2 h sessions. There were no restrictions for TAU. The primary outcome measures were the Beck Anxiety Inventory (BAI) and clinician severity rating from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) for the principal anxiety disorder at post-treatment, with intention-to-treat analysis.
RESULTS
A total of 231 participants were randomized to either tCBT + TAU (117) or TAU (114), with outcome data available for, respectively, 95 and 106. Results of the mixed-effects regression models showed superior improvement at post-treatment for participants in tCBT + TAU, compared to TAU, for BAI [p < 0.001; unadjusted post-treatment mean (s.d.): 13.20 (9.13) v. 20.85 (10.96), Cohen's d = 0.76] and ADIS-5 [p < 0.001; 3.27 (2.19) v. 4.93 (2.00), Cohen's d = 0.79].
CONCLUSIONS
Our findings suggest that the addition of group tCBT into usual care can reduce symptom severity in patients with anxiety disorders, and support tCBT dissemination in routine community-based care.",2020,"Results of the mixed-effects regression models showed superior improvement at post-treatment for participants in tCBT + TAU, compared to TAU, for BAI [p < 0.001; unadjusted post-treatment mean (s.d.): 13.20","['patients with anxiety disorders', 'participants aged 18-65 who met DSM-5 criteria for principal diagnoses of generalized anxiety disorder, social anxiety disorder, panic disorder, or agoraphobia', 'anxiety disorders', '231 participants', 'anxiety disorders in community-based mental health care']","['combining group tCBT with treatment-as-usual (TAU', 'tCBT + TAU', 'transdiagnostic cognitive-behavior therapy', 'Transdiagnostic group cognitive-behavioral therapy (tCBT']","['ADIS-5 ', 'Beck Anxiety Inventory (BAI) and clinician severity rating from the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5) for the principal anxiety disorder at post-treatment, with intention-to-treat analysis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",231.0,0.115214,"Results of the mixed-effects regression models showed superior improvement at post-treatment for participants in tCBT + TAU, compared to TAU, for BAI [p < 0.001; unadjusted post-treatment mean (s.d.): 13.20","[{'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Roberge', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université de Sherbrooke, Sherbrooke (Québec), Canada.'}, {'ForeName': 'Martin D', 'Initials': 'MD', 'LastName': 'Provencher', 'Affiliation': 'École de psychologie, Université Laval, Sherbrooke (Québec), Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gaboury', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université de Sherbrooke, Sherbrooke (Québec), Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Gosselin', 'Affiliation': 'Department of Psychology, Université de Sherbrooke, Sherbrooke (Québec), Canada.'}, {'ForeName': 'Helen-Maria', 'Initials': 'HM', 'LastName': 'Vasiliadis', 'Affiliation': 'Department of Community Health Sciences, Université de Sherbrooke, Québec (Québec), Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Benoît', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université de Sherbrooke, Sherbrooke (Québec), Canada.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Carrier', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université de Sherbrooke, Sherbrooke (Québec), Canada.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Antony', 'Affiliation': 'Department of Psychology, Ryerson University, Toronto (Ontario), Canada.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Chaillet', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproduction, Université Laval, Québec (Québec), Canada.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Houle', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montréal (Québec), Canada.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hudon', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Université de Sherbrooke, Sherbrooke (Québec), Canada.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'The Cairnmillar Institute, Melbourne, Australia.'}]",Psychological medicine,['10.1017/S0033291720004316']
2212,33261510,Live renal ultrasonography facilitates double-J ureteral stent insertion at the bedside: a pilot study for the COVID-19 era.,"OBJECTIVES
To investigate the feasibility and efficacy of live renal ultrasonography to guide double-J ureteral stent placement at the bedside.
PATIENTS AND METHODS
Between April 12 and June 5, 2020, patients presenting with acute ureteral obstruction requiring decompression were prospectively selected for ultrasound-guided bedside ureteral stent placement. During stent placement, upper tract access confirmed using ultrasound with or without retrograde injection of ultrasound contrast prior to double-J stent insertion. A post-procedural abdominal x-ray was obtained for stent position confirmation.
RESULTS
Eight patients (4 men, 4 women) were offered bedside ultrasound-guided ureteral stent placement, and all 8 consented to proceed. Stents were successfully placed in 7 of 8 patients. One patient had an impacted ureterovesical junction stone and stricture requiring ureteroscopy and laser lithotripsy in the operating room. All patients tolerated procedures without immediate complications.
CONCLUSION
Live renal ultrasonography can facilitate a high success rate for bedside ureteral stent placement outside the operating room. This approach is an attractive alternative to fluoroscopy-guided stent placement in the operating room and is of particular value in the COVID-19 era when judicious use of these resources is salient.",2020,"All patients tolerated procedures without immediate complications.
","['One patient had an impacted ureterovesical junction stone and stricture requiring ureteroscopy and laser lithotripsy in the operating room', 'Eight patients (4 men, 4 women', 'Between April 12 and June 5, 2020, patients presenting with acute ureteral obstruction requiring decompression']","['live renal ultrasonography to guide double-J ureteral stent placement', 'ultrasound with or without retrograde injection of ultrasound contrast prior to double-J stent insertion', 'bedside ultrasound-guided ureteral stent placement', 'ultrasound-guided bedside ureteral stent placement', 'Live renal ultrasonography facilitates double-J ureteral stent insertion', 'Live renal ultrasonography']",[],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205144', 'cui_str': 'Junctional'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0041956', 'cui_str': 'Obstruction of ureter'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0183518', 'cui_str': 'Ureteric stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0441293', 'cui_str': 'JJ-stent'}, {'cui': 'C0864052', 'cui_str': 'Ureteral stent insertion'}]",[],,0.0366708,"All patients tolerated procedures without immediate complications.
","[{'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'UCSF, 8785, Urology, 400 Parnassus Ave, A632, San Francisco, California, United States, 94143; heiko.yang@ucsf.edu.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Chappidi', 'Affiliation': 'UCSF, 8785, Urology, San Francisco, California, United States; meera.chappidi@ucsf.edu.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Overland', 'Affiliation': 'UCSF, 8785, Urology, San Francisco, California, United States; maya.overland@ucsf.edu.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'UCSF, 8785, Urology, San Francisco, California, United States; justin.ahn@ucsf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bayne', 'Affiliation': 'UCSF, 8785, Urology, San Francisco, California, United States; david.bayne@ucsf.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chi', 'Affiliation': 'UCSF, 8785, Urology, San Francisco, California, United States; Tom.Chi@ucsf.edu.'}]",Journal of endourology,['10.1089/end.2020.0954']
2213,33261505,Clinical study of a 125I particle-integrated esophageal covered stent and hyperbaric oxygen in the treatment of advanced esophageal cancer.,"OBJECTIVE
This study aimed to investigate the clinical efficacy and feasibility of the treatment of advanced esophageal cancer with a combination of a 125I particle-integrated esophageal covered stent and hyperbaric oxygen.
METHODS
45 patients with advanced esophageal cancer were enrolled and were randomly divided into two groups: a treatment group and a control group. Patients in the treatment group were treated with a 125I particle-integrated esophageal covered stent and hyperbaric oxygen, while patients in the control group were treated with a 125I particle-integrated esophageal covered stent, and the clinical effects and long-term survival time of the two groups were observed.
RESULTS
In the treatment group, the complete remission (CR) rate and partial remission (PR) rate of local lesions were 19.2% and 61.5% respectively, and the total effective rate was 80.7%. In the control group, the CR rate and PR rate of local lesions were 10.5% and 52.6%, respectively, and the total effective rate was 63.1%. The total effective rate was higher in the treatment group than in the control group, and the difference was statistically significant (P < 0.05).
CONCLUSION
The combination of a 125I particle-integrated esophageal covered stent and hyperbaric oxygen shows good short- and long-term efficacy in the treatment of advanced esophageal cancer.",2020,"The total effective rate was higher in the treatment group than in the control group, and the difference was statistically significant (P < 0.05).
","['45 patients with advanced esophageal cancer', 'advanced esophageal cancer']",['125I particle-integrated esophageal covered stent and hyperbaric oxygen'],"['complete remission (CR) rate and partial remission (PR) rate of local lesions', 'total effective rate', 'CR rate and PR rate of local lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",45.0,0.0272519,"The total effective rate was higher in the treatment group than in the control group, and the difference was statistically significant (P < 0.05).
","[{'ForeName': 'Qizhou', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Guangdong TCM-Integrated Hospital, China.'}, {'ForeName': 'Guo-Liang', 'Initials': 'GL', 'LastName': 'Li', 'Affiliation': 'Guangdong TCM-Integrated Hospital.'}, {'ForeName': 'Jian-Biao', 'Initials': 'JB', 'LastName': 'Shang', 'Affiliation': 'Wuyi Hospital of Traditional Chinese medicine.'}, {'ForeName': 'Yi-Min', 'Initials': 'YM', 'LastName': 'Ren', 'Affiliation': 'the First Affiliated Hospital of Guangzhou Medical University.'}, {'ForeName': 'Jian-Li', 'Initials': 'JL', 'LastName': 'Xie', 'Affiliation': ""Gaoming People's Hospital.""}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2020.7377/2020']
2214,33261355,"Investigating fractal dimension, heart rate variability, and memory during different image sequencing regimes in young adults.","The goal of this study is to investigate patterns that emerge in brain and heart signals in response to external stimulating image regimes. Data were collected from 84 subjects of ages 18-22. Subjects viewed a series of both neutrally and negatively arousing pictures during 2-min and 18-s-long segments repeated nine times. Both brain [electroencephalogram (EEG)] and heart signals [electrocardiogram (EKG)] were recorded for the duration of the study (ranging from 1.5 to 2.5 h) and analyzed using nonlinear techniques. Specifically, the fractal dimension was computed from the EEG to determine how this voltage trace is related to the image sequencing. Our results showed that subjects visually stimulated by a series of mixed images (a randomized set of neutrally or negatively arousing images) had a significantly higher fractal dimension compared to subjects visually triggered by pure images (an organized set of either all neutral or all negatively arousing images). In addition, our results showed that subjects who performed better on memory recall had a higher fractal dimension computed from the EEG. Analysis of EKG also showed greater heart rate variability in subjects who viewed a series of mixed images compared to subjects visually triggered by pure images. Overall, our results show that the healthy brain and heart are responsive to environmental stimuli that promote adaptability, flexibility, and agility.",2020,Analysis of EKG also showed greater heart rate variability in subjects who viewed a series of mixed images compared to subjects visually triggered by pure images.,"['young adults', '84 subjects of ages 18-22']",[],"['Investigating fractal dimension, heart rate variability, and memory', 'Both brain [electroencephalogram (EEG)] and heart signals [electrocardiogram (EKG', 'fractal dimension', 'heart rate variability']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0206163', 'cui_str': 'Fractals'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",84.0,0.0210575,Analysis of EKG also showed greater heart rate variability in subjects who viewed a series of mixed images compared to subjects visually triggered by pure images.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aguillard', 'Affiliation': 'Department of Physics, Wofford College, 429 N Church Street, Spartanburg, South Carolina 29303, USA.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Zarubin', 'Affiliation': 'Department of Psychology, Wofford College, 429 N Church Street, Spartanburg, South Carolina 29303, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wilson', 'Affiliation': 'Department of Physics, Wofford College, 429 N Church Street, Spartanburg, South Carolina 29303, USA.'}, {'ForeName': 'Katherine R Mickley', 'Initials': 'KRM', 'LastName': 'Steinmetz', 'Affiliation': 'Department of Psychology, Wofford College, 429 N Church Street, Spartanburg, South Carolina 29303, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Martsberger', 'Affiliation': 'Department of Physics, Wofford College, 429 N Church Street, Spartanburg, South Carolina 29303, USA.'}]","Chaos (Woodbury, N.Y.)",['10.1063/5.0002764']
2215,33261155,"No Difference in Weight Loss, Glucose, Lipids and Vitamin D of Eggs for Breakfast Compared with Cereal for Breakfast during Energy Restriction.","The aim of the study was to investigate the impact of consuming 2 eggs for breakfast 5 days per week compared with eating breakfast cereal in a randomized parallel study. Two energy-restricted diets with a similar energy content were compared over a 6-month period. One hundred and ten participants-aged 56 ± 16 years, BMI 34 ± 6 kg·m 2 , 84 women and 26 men-commenced and 76 completed the study, 33 in the egg group and 43 in the cereal group. Weight loss in completers was 8.1 kg ± 7.0 kg (8.8 ± 6.4%) in the egg group and 7.3 kg ± 4.0 kg (7.6 ± 4.6%) in the cereal group ( p < 0.001 for time) but there was no differential effect of diet ( p = 0.56). Vitamin D was 55 ± 18 nmol/L at baseline rose at 3 months and fell at 6 months but remained higher than baseline ( p < 0.001 for time) with no difference between the groups. Vitamin D levels were inversely correlated with BMI (r = -0.22 p = 0.025) and positively with age (r = 0.26 p = 0.009), and change in Vitamin D was positively correlated with weight change at 3 and 6 months (r = 0.46 and r = 0.41 both p < 0.001). In a post-hoc analysis of obese participants there was an effect of time ( p < 0.01) and a time by diet interaction ( p < 0.04), such that participants in the egg group maintained the increase in Vitamin D levels at 6-months. There was no effect on glucose and no adverse effects on total and LDL cholesterol, which did not change. In conclusion, both diets achieved clinically meaningful weight loss. There were no adverse effects on LDL-cholesterol, and there may be a beneficial effect on Vitamin D in people with obesity but this remains to be investigated in a prospective study.",2020,Vitamin D was 55 ± 18 nmol/L at baseline rose at 3 months and fell at 6 months but remained higher than baseline ( p < 0.001 for time) with no difference between the groups.,"['One hundred and ten participants-aged 56 ± 16 years, BMI 34 ± 6 kg·m 2 , 84 women and 26 men-commenced and 76 completed the study, 33 in the egg group and 43 in the cereal group', 'people with obesity']",['eating breakfast cereal'],"['Weight Loss, Glucose, Lipids and Vitamin D of Eggs for Breakfast', 'clinically meaningful weight loss', 'Vitamin D levels', 'weight change', 'BMI', 'glucose and no adverse effects on total and LDL cholesterol', 'Vitamin D', 'change in Vitamin D', 'Weight loss']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0452557', 'cui_str': 'Breakfast cereal'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0853204', 'cui_str': 'No adverse effect'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",110.0,0.146655,Vitamin D was 55 ± 18 nmol/L at baseline rose at 3 months and fell at 6 months but remained higher than baseline ( p < 0.001 for time) with no difference between the groups.,"[{'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Keogh', 'Affiliation': 'UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Clifton', 'Affiliation': 'UniSA Clinical and Health Sciences, University of South Australia, Adelaide, SA 5000, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17238827']
2216,33260915,"Effects of Two-Week Betaine Supplementation on Apoptosis, Oxidative Stress, and Aerobic Capacity after Exhaustive Endurance Exercise.","This study evaluated the effects of 2 weeks of betaine supplementation on apoptosis, oxidative stress, and aerobic capacity after exhaustive endurance exercise (EEE). A double-blind, crossover, and counterbalanced design was adopted, with 10 healthy male participants asked to consume betaine (1.25 g of betaine mixed with 300 mL of sports beverage, twice per day for 2 weeks) or placebo (300 mL of sports beverage). All participants performed a graded exercise test on a treadmill to determine the maximal oxygen consumption (VO 2max ) before supplementation and then performed the EEE test at an intensity of 80% VO 2max after 2 weeks of supplementation. The time to exhaustion, peak oxygen consumption, maximal heart rate, and average heart rate were recorded during the EEE test. Venous blood samples were drawn before, immediately after, and 3 h after the EEE test to assess apoptosis and the mitochondrial transmembrane potential (MTP) decline of lymphocytes as well as the concentrations of thiobarbituric acid reactive substance and protein carbonyl. The results indicated that lymphocyte apoptosis was significantly higher immediately after and 3 h after EEE than before exercise in participants in the placebo trial. However, lymphocyte apoptosis exhibited no significant differences among the three time points in participants in the betaine trial. Moreover, apoptosis in the betaine trial was significantly lower immediately after and 3 h after exercise compared with the placebo trial. No differences were noted for other variables. Thus, 2 weeks of betaine supplementation can effectively attenuate lymphocyte apoptosis, which is elevated by EEE. However, betaine supplementation exhibited no effects on MTP decline, oxidative stress, or aerobic capacity.",2020,"Moreover, apoptosis in the betaine trial was significantly lower immediately after and 3 h after exercise compared with the placebo trial.",['10 healthy male participants asked to'],"['consume betaine (1.25 g of betaine mixed with 300 mL of sports beverage, twice per day for 2 weeks) or placebo', 'Two-Week Betaine Supplementation', 'exhaustive endurance exercise (EEE', 'betaine supplementation']","['apoptosis, oxidative stress, and aerobic capacity', 'maximal oxygen consumption (VO 2max ', 'Apoptosis, Oxidative Stress, and Aerobic Capacity', 'time to exhaustion, peak oxygen consumption, maximal heart rate, and average heart rate', 'lymphocyte apoptosis', 'MTP decline, oxidative stress, or aerobic capacity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}]","[{'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C4517497', 'cui_str': '1.25'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0065610', 'cui_str': 'Maltose tetrapalmitate'}]",10.0,0.263447,"Moreover, apoptosis in the betaine trial was significantly lower immediately after and 3 h after exercise compared with the placebo trial.","[{'ForeName': 'Ming-Ta', 'Initials': 'MT', 'LastName': 'Yang', 'Affiliation': 'Center for General Education, Taipei Medical University, Taipei 110301, Taiwan.'}, {'ForeName': 'Xiu-Xin', 'Initials': 'XX', 'LastName': 'Lee', 'Affiliation': 'Department of Primary Care Medicine, Taipei Medical University-Shuang Ho Hospital, New Taipei City 23561, Taiwan.'}, {'ForeName': 'Bo-Huei', 'Initials': 'BH', 'LastName': 'Huang', 'Affiliation': 'Charles Perkins Centre, School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown 2006, Australia.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Chien', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Office of Physical Education, National Taipei University of Business, Taipei 10051, Taiwan.'}, {'ForeName': 'Kuei-Hui', 'Initials': 'KH', 'LastName': 'Chan', 'Affiliation': 'Graduate Institute of Athletics and Coaching Science, National Taiwan Sport University, Taoyuan 333325, Taiwan.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9121189']
2217,33260823,Cognitive Insight in First-Episode Psychosis: Changes during Metacognitive Training.,"BACKGROUND
Metacognitive training (MCT) has demonstrated its efficacy in psychosis. However, the effect of each MCT session has not been studied. The aim of the study was to assess changes in cognitive insight after MCT: (a) between baseline, post-treatment, and follow-up; (b) after each session of the MCT controlled for intellectual quotient (IQ) and educational level.
METHOD
A total of 65 patients with first-episode psychosis were included in the MCT group from nine centers of Spain. Patients were assessed at baseline, post-treatment, and 6 months follow-up, as well as after each session of MCT with the Beck Cognitive Insight Scale (BCIS). The BCIS contains two subscales: self-reflectiveness and self-certainty, and the Composite Index. Statistical analysis was performed using linear mixed models with repeated measures at different time points.
RESULTS
Self-certainty decreased significantly ( p = 0.03) over time and the effect of IQ was negative and significant ( p = 0.02). From session 4 to session 8, all sessions improved cognitive insight by significantly reducing self-certainty and the Composite Index.
CONCLUSIONS
MCT intervention appears to have beneficial effects on cognitive insight by reducing self-certainty, especially after four sessions. Moreover, a minimum IQ is required to ensure benefits from MCT group intervention.",2020,"RESULTS
Self-certainty decreased significantly ( p = 0.03) over time and the effect of IQ was negative and significant ( p = 0.02).",['65 patients with first-episode psychosis were included in the MCT group from nine centers of Spain'],"['Metacognitive Training', 'MCT', 'MCT session', 'MCT intervention', 'Metacognitive training (MCT']","['Self-certainty', 'Beck Cognitive Insight Scale (BCIS', 'cognitive insight by significantly reducing self-certainty and the Composite Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",65.0,0.0353521,"RESULTS
Self-certainty decreased significantly ( p = 0.03) over time and the effect of IQ was negative and significant ( p = 0.02).","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Birulés', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, 08830 Barcelona, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'López-Carrilero', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, 08830 Barcelona, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cuadras', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, 08830 Barcelona, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Pousa', 'Affiliation': 'Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Barrigón', 'Affiliation': 'Psychiatry Service, Area de Gestión Sanitaria Sur Granada, Motril, 18600 Granada, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Barajas', 'Affiliation': ""Centre d'Higiene Mental Les Corts, 08029 Barcelona, Spain.""}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Lorente-Rovira', 'Affiliation': 'Investigación Biomédica en Red de Salud Mental (CIBERSAM) Instituto de Salud Carlos III C/Monforte de Lemos 3-5, Pabellón 11, Planta 0, 28029 Madrid, Spain.'}, {'ForeName': 'Fermín', 'Initials': 'F', 'LastName': 'González-Higueras', 'Affiliation': 'UGC Salud Mental de Jaén, Servicio Andaluz de Salud, 23007 Jaen, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Grasa', 'Affiliation': 'Investigación Biomédica en Red de Salud Mental (CIBERSAM) Instituto de Salud Carlos III C/Monforte de Lemos 3-5, Pabellón 11, Planta 0, 28029 Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Ruiz-Delgado', 'Affiliation': 'Unidad de Salud Mental Comunitaria Málaga Norte, UGC Salud Mental Carlos Haya, Servicio Andaluz de Salud Psychiatry Service, Antequera, 29200 Málaga, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cid', 'Affiliation': ""Mental Health & Addiction Research Group, IdiBGi, Institut d'Assistència Sanitària, 17190 Girona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Apraiz', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, 08830 Barcelona, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Montserrat', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, 08830 Barcelona, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Pélaez', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, 08830 Barcelona, Spain.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg, 20251 Hamburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': 'The Spanish Metacognition Study Group', 'Affiliation': 'Sant Boi de Llobregat, 08830 Barcelona, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Ochoa', 'Affiliation': 'Parc Sanitari Sant Joan de Déu, Sant Boi de Llobregat, 08830 Barcelona, Spain.'}]",Journal of personalized medicine,['10.3390/jpm10040253']
2218,33260785,Effect of an Aquatic Balance-Training Program in Patients with Chronic Stroke: A Single-Group Experimental Pilot Study.,"Background and Objectives : Stroke survivors face severe problems affecting their mobility, such as balance impairments and an increased risk of falls. The principal aim of this study was to quantify the effects of 12 sessions of Halliwick aquatic therapy for the treatment of balance in patients with chronic stroke. Materials and Methods : Twenty-nine people with stroke participated in this single-group experimental pilot study. Sessions were performed three times a week for a total of 12 sessions. A stabilometric assessment was conducted using a computerized platform. The evaluations were performed at baseline, at four weeks, and one month after completing the aquatic program. Results : The results obtained revealed significant differences for postural stability values ( p < 0.001) and single-leg stabilometry. However, in the case of values within the limits of stability, such as forward (F = 0.339, p = 0.676), backward (F = 0.449, p = 0.644), forward right oscillations (F = 1.637, p = 0.21), and the anterior/posterior instability index (F = 0.614, p = 0.55), no significant differences were found. Conclusions : These findings suggest that Halliwick therapy may potentially improve stroke balance impairments. The main limitations of the study were the sample size, the lack of a control group, and the study not being blind.",2020,The results obtained revealed significant differences for postural stability values ( p < 0.001) and single-leg stabilometry.,"['patients with chronic stroke', 'Patients with Chronic Stroke', 'Twenty-nine people with stroke']","['Halliwick aquatic therapy', 'Aquatic Balance-Training Program', 'Materials and Methods ']","['anterior/posterior instability index', 'stroke balance impairments', 'forward right oscillations', 'postural stability values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0241981', 'cui_str': 'Impairment of balance'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",29.0,0.0203375,The results obtained revealed significant differences for postural stability values ( p < 0.001) and single-leg stabilometry.,"[{'ForeName': 'Sagrario', 'Initials': 'S', 'LastName': 'Pérez-de la Cruz', 'Affiliation': 'Department of Nursing, Physiotherapy and Medicine, University of Almería, 04120 Almería, Spain.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56120656']
2219,33260552,"Subacute Ingestion of Caffeine and Oolong Tea Increases Fat Oxidation without Affecting Energy Expenditure and Sleep Architecture: A Randomized, Placebo-Controlled, Double-Blinded Cross-Over Trial.","Ingesting oolong tea or caffeine acutely increases energy expenditure, and oolong tea, but not caffeine, stimulates fat oxidation. The acute effects of caffeine, such as increased heart rate and interference with sleep, diminish over 1-4 days, known as caffeine tolerance. During each 14-day session of the present study, 12 non-obese males consumed oolong tea (100 mg caffeine, 21.4 mg gallic acid, 97 mg catechins and 125 mg polymerized polyphenol), caffeine (100 mg), or placebo at breakfast and lunch. On day 14 of each session, 24-h indirect calorimetry and polysomnographic sleep recording were performed. Caffeine and oolong tea increased fat oxidation by ~20% without affecting energy expenditure over 24-h. The decrease in the respiratory quotient by oolong tea was greater than that by caffeine during sleep. The effect of oolong tea on fat oxidation was salient in the post-absorptive state. These findings suggest a role of unidentified ingredients in oolong tea to stimulate fat oxidation, and this effect is partially suppressed in a postprandial state. Two weeks of caffeine or oolong tea ingestion increased fat oxidation without interfering with sleep. The effects of subacute ingestion of caffeine and oolong tea differed from the acute effects, which is a particularly important consideration regarding habitual tea consumption.",2020,Caffeine and oolong tea increased fat oxidation by ~20% without affecting energy expenditure over 24-h.,['12 non-obese males'],"['caffeine', 'Caffeine and Oolong Tea Increases Fat Oxidation', 'consumed oolong tea (100 mg caffeine, 21.4 mg gallic acid, 97 mg catechins and 125 mg polymerized polyphenol), caffeine', 'placebo', 'Ingesting oolong tea or caffeine', 'Caffeine and oolong tea', 'caffeine or oolong tea ingestion', 'caffeine and oolong tea', 'Placebo']","['fat oxidation', 'fat oxidation without interfering with sleep', 'respiratory quotient', 'heart rate and interference with sleep', 'energy expenditure, and oolong tea']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0016979', 'cui_str': 'Gallic acid'}, {'cui': 'C0007404', 'cui_str': 'Catechin'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]",12.0,0.20464,Caffeine and oolong tea increased fat oxidation by ~20% without affecting energy expenditure over 24-h.,"[{'ForeName': 'Simeng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Takano', 'Affiliation': 'Research Institute, Suntory Global Innovation Center Ltd., Soraku, Kyoto 619-0284, Japan.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Murayama', 'Affiliation': 'Research Institute, Suntory Global Innovation Center Ltd., Soraku, Kyoto 619-0284, Japan.'}, {'ForeName': 'Morie', 'Initials': 'M', 'LastName': 'Tominaga', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Insung', 'Initials': 'I', 'LastName': 'Park', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Jaehoon', 'Initials': 'J', 'LastName': 'Seol', 'Affiliation': 'R&D Center for Tailor-Made QOL, University of Tsukuba, Tsukuba, Ibaraki 305-8550, Japan.'}, {'ForeName': 'Asuka', 'Initials': 'A', 'LastName': 'Ishihara', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Yajima', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Josai University, Saitama 350-0295, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Suzuki', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Fukusumi', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yanagisawa', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kokubo', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}, {'ForeName': 'Kumpei', 'Initials': 'K', 'LastName': 'Tokuyama', 'Affiliation': 'International Institute for Integrative Sleep Medicine (WPI-IIIS), University of Tsukuba, Tsukuba, Ibaraki 305-8575, Japan.'}]",Nutrients,['10.3390/nu12123671']
2220,33260523,Cooking as a Health Behavior: Examining the Role of Cooking Classes in a Weight Loss Intervention.,"Americans are cooking fewer meals at home and eating more convenience foods prepared elsewhere. Cooking at home is associated with higher quality diets, while a reduction in cooking may be associated with increases in obesity and risk factors for chronic disease. The aims of this study were to examine cooking as an intervention for weight control in overweight and obese adults, and whether such an intervention increases participants' food agency and diet quality. Overweight and obese adults were randomized into one of two intervention conditions: active or demonstration. Both conditions received the same 24-week behavioral weight loss intervention, and bi-weekly cooking classes. The active condition prepared a weekly meal during a hands-on lesson, while the demonstration condition observed a chef prepare the same meal. The active condition lost significantly more weight at six months compared with the demonstration condition (7.3% vs. 4.5%). Both conditions saw significant improvements in food agency scores and Healthy Eating Index scores, though no significant differences were noted between groups. The addition of active cooking to a weight management intervention may improve weight loss outcomes, though benefits in diet quality and cooking behaviors may also be seen with the addition of a demonstration-only cooking intervention.",2020,"Both conditions saw significant improvements in food agency scores and Healthy Eating Index scores, though no significant differences were noted between groups.","['overweight and obese adults', 'Overweight and obese adults']","['behavioral weight loss intervention, and bi-weekly cooking classes']","['weight loss outcomes', 'food agency scores and Healthy Eating Index scores']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}]",,0.0209161,"Both conditions saw significant improvements in food agency scores and Healthy Eating Index scores, though no significant differences were noted between groups.","[{'ForeName': 'Mattie', 'Initials': 'M', 'LastName': 'Alpaugh', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, VT 05403, USA.'}, {'ForeName': 'Lizzy', 'Initials': 'L', 'LastName': 'Pope', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, VT 05403, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Trubek', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, VT 05403, USA.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Skelly', 'Affiliation': 'Department of Medical Biostatistics, University of Vermont, Burlington, VT 05403, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Vermont, Burlington, VT 05403, USA.'}]",Nutrients,['10.3390/nu12123669']
2221,33260471,"Prenatal Counseling throughout Pregnancy: Effects on Physical Activity Level, Perceived Barriers, and Perinatal Health Outcomes: A Quasi-Experimental Study.","Physical activity during pregnancy has many health benefits. However, the physical activity level is insufficient throughout pregnancy and women report perceived barriers to physical activity. This study assessed the impact of a counseling intervention offered in addition to routine pregnancy care on physical activity patterns, perceived barriers, and perinatal health outcomes. A quasi-experimental trial was conducted in the Maternity Unit of a hospital in Guadeloupe (a French department). Ninety-six pregnant women were allocated to a control or intervention group. Regular physical activity counseling was dispensed to the women in the intervention group by trained healthcare providers. The physical activity level and the perceived barriers were assessed in each trimester. Outcomes for the perinatal health of the mother and child were measured throughout pregnancy and after delivery. The perceived barriers, such as a lack of information about the health benefits and risks over the two trimesters (all p < 0.05) and insecurity related to practice throughout pregnancy (all p < 0.05), were different in favor of the intervention group. There were no significant between-group differences for the major indices of physical activity, whether measured or reported. The intervention women reported significantly more sedentary activity compared with the control group in the third trimester, 64.7 (36.4-78.7) vs. 22.7 (9.4-49.8) MET-hours/week, respectively ( p < 0.001). The perinatal health outcomes for the mother and child showed no significant differences. The intervention was unable to limit the decline in physical activity or improve health outcomes. However, it was associated with an improvement in the perception of barriers. Future research should focus on interventions that have a sufficient quantitative impact on perceived barriers in order to limit physical activity decline.",2020,"The intervention women reported significantly more sedentary activity compared with the control group in the third trimester, 64.7 (36.4-78.7) vs. 22.7 (9.4-49.8) MET-hours/week, respectively ( p < 0.001).","['Maternity Unit of a hospital in Guadeloupe (a French department', 'Ninety-six pregnant women']","['counseling intervention', 'Regular physical activity counseling']","['perinatal health outcomes', 'physical activity level', 'physical activity', 'Physical activity', 'physical activity or improve health outcomes', 'physical activity patterns, perceived barriers, and perinatal health outcomes', 'sedentary activity', 'Physical Activity Level, Perceived Barriers, and Perinatal Health Outcomes']","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",96.0,0.0204504,"The intervention women reported significantly more sedentary activity compared with the control group in the third trimester, 64.7 (36.4-78.7) vs. 22.7 (9.4-49.8) MET-hours/week, respectively ( p < 0.001).","[{'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Ruart', 'Affiliation': 'Laboratory ACTES EA3596, Univ Antilles, 97159 Pointe-à-Pitre, Guadeloupe, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Sinnapah', 'Affiliation': 'Laboratory ACTES EA3596, Univ Antilles, 97159 Pointe-à-Pitre, Guadeloupe, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hue', 'Affiliation': 'Laboratory ACTES EA3596, Univ Antilles, 97159 Pointe-à-Pitre, Guadeloupe, France.'}, {'ForeName': 'Eustase', 'Initials': 'E', 'LastName': 'Janky', 'Affiliation': 'Gynaecology, Obstetrics Department, University Hospital of Guadeloupe, 97159 Pointe-à-Pitre, Guadeloupe, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Antoine-Jonville', 'Affiliation': 'Laboratory ACTES EA3596, Univ Antilles, 97159 Pointe-à-Pitre, Guadeloupe, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17238887']
2222,33260468,Longitudinal Changes in Food Addiction Symptoms and Body Weight among Adults in a Behavioral Weight-Loss Program.,"Interest in food addiction (FA) has increased, but little is known about its clinical implications or potential treatments. Using secondary analyses from a randomized controlled trial, we evaluated the associations between changes in FA, body weight, and ""problem food"" consumption during a 22-month behavioral weight-loss program consisting of an initial four-month in-person intervention, 12-month extended-care, and six-month follow-up ( n = 182). Food addiction was measured using the Yale Food Addiction Scale. ""Problem foods"" were identified from the literature and self-reporting. Multilevel modeling was used as the primary method of analysis. We hypothesized that reductions in problem food consumption during the initial treatment phase would be associated with long-term (22-month) FA reductions. As expected, we found that reductions in problem foods were associated with greater initial reductions in FA symptoms; however, they were also associated with a sharper rebound in symptoms over time ( p = 0.016), resulting in no significant difference at Month 22 ( p = 0.856). Next, we hypothesized that long-term changes in FA would be associated with long-term changes in body weight. Although both FA and weight decreased over time ( p s < 0.05), month-to-month changes in FA were not associated with month-to-month changes in weight ( p = 0.706). Instead, higher overall FA (i.e., mean scores over the course of the study) were associated with less weight loss ( p = 0.008) over time. Finally, we hypothesized that initial reductions in problem food consumption would be associated with long-term reductions in weight, but this relationship was not significant ( p s > 0.05). Given the complexity of the findings, more research is needed to identify interventions for long-term changes in FA and to elucidate the associations between problem foods, FA, and weight.",2020,"Although both FA and weight decreased over time ( p s < 0.05), month-to-month changes in FA were not associated with month-to-month changes in weight ( p = 0.706).",['Adults in a Behavioral Weight-Loss Program'],[],"['weight loss', 'problem food consumption', 'overall FA', 'Food addiction', 'FA, body weight, and ""problem food"" consumption', 'FA symptoms', 'Food Addiction Symptoms and Body Weight', 'Yale Food Addiction Scale. ']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4505163', 'cui_str': 'Food Addiction'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0175224,"Although both FA and weight decreased over time ( p s < 0.05), month-to-month changes in FA were not associated with month-to-month changes in weight ( p = 0.706).","[{'ForeName': 'Eliza L', 'Initials': 'EL', 'LastName': 'Gordon', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, P.O. Box 100165, Gainesville, FL 32610, USA.'}, {'ForeName': 'Lisa J', 'Initials': 'LJ', 'LastName': 'Merlo', 'Affiliation': 'Department of Psychiatry, McKnight Brain Institute, University of Florida College of Medicine, L4-100K, P.O. Box 100256, Gainesville, FL 32611, USA.'}, {'ForeName': 'Patricia E', 'Initials': 'PE', 'LastName': 'Durning', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, P.O. Box 100165, Gainesville, FL 32610, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, P.O. Box 100165, Gainesville, FL 32610, USA.'}]",Nutrients,['10.3390/nu12123687']
2223,33260442,Dietary Contributors to Food Group Intake in Preschool Children Attending Family Childcare Homes: Differences between Latino and Non-Latino Providers.,"While there are several factors that contribute to the diet quality of children in childcare, one contributing factor in Family Childcare Homes (FCCHs) is the provider's ethnicity. However, research examining the food items provided in this setting is limited; in particular, with regards to differences between FCCHs of Latino and non-Latino providers. The aim of this study was to identify and describe the food items that contribute to food group intake in preschool-aged children attending FCCHs, and to examine differences by provider ethnicity. This secondary data analysis used baseline data from Healthy Start/Comienzos Sanos: a cluster-randomized trial. Children's dietary intake was collected using the Dietary Observation in Child Care method and entered into Nutrition Data System for Research software. Food groups were based on the Nutrition Coordinating Center classification. Contribution of food items to their respective food group was calculated as a proportion, using ratio of means and presented as a percentage. Ethnic differences were tested with ANCOVA ( p < 0.05) with Bonferroni adjustments for multiple comparisons. All providers ( n = 120) were female and 67.5% were Latino. Most fruit consumed by children was in the form of juice (85%), three-fourths of the grains consumed were refined (75%), and half of the sweets consumed were syrup/honey/jelly (50%). Most of the vegetables consumed were non-starchy (61%), nearly three-fourths of dairy consumed was low-fat (71%), and vegetable oils contributed the most to the fats group (89%). Food items differed by provider's ethnicity, with children cared for by non-Latino providers consuming a higher proportion of fruit juice, animal fats and a lower proportion of legumes ( p < 0.001 for all). Children with Latino providers consumed a lower proportion of non-starchy vegetables, low-fat dairy, and nuts/seeds ( p < 0.001 for all). FCCH providers could offer more whole fruits and grains and a greater variety of vegetables. Differences by ethnicity suggest providers could benefit from culturally tailored recommendations.",2020,"Children with Latino providers consumed a lower proportion of non-starchy vegetables, low-fat dairy, and nuts/seeds ( p < 0.001 for all).","['Children with Latino providers', 'Preschool Children', 'Attending Family Childcare Homes', 'preschool-aged children attending FCCHs', 'All providers ( n = 120) were female and 67.5% were Latino']",[],['proportion of non-starchy vegetables'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0042440', 'cui_str': 'Vegetable'}]",120.0,0.0335028,"Children with Latino providers consumed a lower proportion of non-starchy vegetables, low-fat dairy, and nuts/seeds ( p < 0.001 for all).","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ramirez', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Risica', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI 02912, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Human Development & Family Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Greaney', 'Affiliation': 'Department of Health Studies, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Noereem Z', 'Initials': 'NZ', 'LastName': 'Mena', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Cooksey Stowers', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT 06269, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Tovar', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island, Kingston, RI 02881, USA.'}]",Nutrients,['10.3390/nu12123686']
2224,33260423,"Eating Behavior, Physical Activity and Exercise Training: A Randomized Controlled Trial in Young Healthy Adults.","Regular physical activity (PA) is an important part of the treatment of several medical conditions, including overweight and obesity, in which there may be a weakened appetite control. Eating behaviour traits influence weight control and may be different in active and sedentary subjects. This paper reports the relationships between the time spent in sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits in young, healthy adults. Additionally, it reports the results of a six-month-long, randomized, controlled trial to examine the effect of an exercise intervention on eating behaviour traits. A total of 139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m 2 were enrolled. Baseline assessments of habitual PA were made using wrist-worn triaxial accelerometers; eating behaviour traits were examined via the self-reported questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire. The subjects were then randomly assigned to one of three groups: control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training). At baseline, sedentary behaviour was inversely associated with binge eating ( r = -0.181, p < 0.05) and with uncontrolled eating ( r = -0.286, p = 0.001). Moderate PA (MPA) was inversely associated with craving control ( r = -0.188, p < 0.05). Moderate-to-vigorous PA (MVPA) was directly associated with binge eating ( r = 0.302, p < 0.001) and uncontrolled eating ( r = 0.346, p < 0.001), and inversely associated with craving control ( r = -0.170, p < 0.015). Overall, PA was directly associated with binge eating ( r = 0.275, p = 0.001), uncontrolled eating ( r = 0.321, p < 0.001) and emotional eating ( r = 0.204, p < 0.05). Additionally, only emotional eating was modified by the intervention, increasing in the vigorous-intensity exercise group ( p < 0.05). In summary, we observed that time spent in sedentary behaviour/PA of different intensity is associated with eating behaviour traits, especially binge eating in young adults. In contrast, the six-month exercise intervention did not lead to appreciable changes in eating behaviour traits.",2020,"Moderate-to-vigorous PA (MVPA) was directly associated with binge eating ( r = 0.302, p < 0.001) and uncontrolled eating ( r = 0.346, p < 0.001), and inversely associated with craving control ( r = -0.170, p < 0.015).","['young, healthy adults', 'active and sedentary subjects', 'Young Healthy Adults', '139 young (22.06 ± 2.26 years) healthy adults (68.35% women) with a Body Mass Index (BMI) of 24.95 ± 4.57 kg/m 2 were enrolled']","['Regular physical activity (PA', 'Eating Behavior, Physical Activity and Exercise Training', 'exercise intervention', 'control (usual lifestyle), moderate-intensity exercise (aerobic and resistance training 3¨C4 days/week at a heart rate equivalent to 60% of the heart rate reserve (HRres) for the aerobic component, and at 50% of the 1 repetition maximum (RM) for the resistance component), or vigorous-intensity exercise (the same training but at 80% HRres for half of the aerobic training, and 70% RM for the resistance training']","['emotional eating', 'craving control', 'binge eating', 'sedentary behaviour', 'Moderate PA (MPA', 'Moderate-to-vigorous PA (MVPA', 'questionnaires: Binge Eating, Three-Factor Eating Questionnaire-R18 and Control of Eating Questionnaire', 'eating behaviour traits', 'uncontrolled eating', 'sedentary behaviour and physical activity (PA) of different intensity, and eating behaviour traits']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",139.0,0.026801,"Moderate-to-vigorous PA (MVPA) was directly associated with binge eating ( r = 0.302, p < 0.001) and uncontrolled eating ( r = 0.346, p < 0.001), and inversely associated with craving control ( r = -0.170, p < 0.015).","[{'ForeName': 'Wendy D', 'Initials': 'WD', 'LastName': 'Martinez-Avila', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Sanchez-Delgado', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Acosta', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Jurado-Fasoli', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Oustric', 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Idoia', 'Initials': 'I', 'LastName': 'Labayen', 'Affiliation': ""Institute for Innovation & Sustainable Development in Food Chain (IS-FOOD), IDISNA, Navarra's Health Research Institute (IdiSNA), Public University of Navarra, 31006 Pamplona, Spain.""}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Blundell', 'Affiliation': 'Appetite Control and Energy Balance Group, School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds LS2 9JT, UK.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), University of Granada, 18007 Granada, Spain.'}]",Nutrients,['10.3390/nu12123685']
2225,33260376,"Effects of Citicoline, Homotaurine, and Vitamin E on Contrast Sensitivity and Visual-Related Quality of Life in Patients with Primary Open-Angle Glaucoma: A Preliminary Study.","The aim of the present study was to evaluate the effects of supplementation with a fixed combination of citicoline 500 mg, homotaurine 50 mg, and vitamin E 12 mg (CIT/HOMO/VITE) on contrast sensitivity and visual-related quality of life in patients with primary open-angle glaucoma (POAG) in mild stage. This was a multicenter, observational, cross-over, short-term, pilot study on POAG patients with stable controlled intraocular pressure (IOP). Patients were randomly assigned to Group 1 (current topical therapy for 4 months and then current topical therapy plus CIT/HOMO/VITE for 4 months) or Group 2 (CIT/HOMO/VITE in addition to current topical therapy for 4 months and then topical therapy alone for 4 months). Best-corrected visual acuity, IOP, visual field, and the Spaeth/Richman contrast sensitivity (SPARCS) test score were recorded at baseline and after 4 and 8 months. The Glaucoma Quality of Life-15 (GQL-15) questionnaire was administered at each check time. Forty-four patients were assigned to Group 1 and 65 to Group 2. Over the follow-up period, there were no significant changes in IOP or visual field findings, whereas SPARCS and GQL-15 findings significantly varied from baseline, both being improved in subjects treated with CIT/HOMO/VITE fixed combination. These results demonstrate that a daily intake of a fixed combination of citicoline, homotaurine, and vitamin E in addition to the topical medical treatment significantly increased the total score of the contrast sensitivity test and the quality of life in patients with POAG.",2020,"Over the follow-up period, there were no significant changes in IOP or visual field findings, whereas SPARCS and GQL-15 findings significantly varied from baseline, both being improved in subjects treated with CIT/HOMO/VITE fixed combination.","['patients with POAG', 'POAG patients with stable controlled intraocular pressure (IOP', 'Patients with Primary Open-Angle Glaucoma', 'patients with primary open-angle glaucoma (POAG) in mild stage']","['Citicoline, Homotaurine, and Vitamin E', 'current topical therapy plus CIT/HOMO/VITE for 4 months) or Group 2 (CIT/HOMO/VITE in addition to current topical therapy', 'citicoline 500 mg, homotaurine 50 mg, and vitamin E 12 mg (CIT/HOMO/VITE']","['Glaucoma Quality of Life-15 (GQL-15) questionnaire', 'Best-corrected visual acuity, IOP, visual field, and the Spaeth/Richman contrast sensitivity (SPARCS) test score', 'IOP or visual field findings', 'Contrast Sensitivity and Visual-Related Quality of Life', 'contrast sensitivity and visual-related quality of life', 'total score of the contrast sensitivity test and the quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0062961', 'cui_str': 'tramiprosate'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C1300203', 'cui_str': 'Genus Homo'}, {'cui': 'C1142098', 'cui_str': 'Vitamin E measurement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C2920155', 'cui_str': 'Citicoline 500 MG'}]","[{'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0846621', 'cui_str': 'Contrast sensitivity test'}]",44.0,0.0794486,"Over the follow-up period, there were no significant changes in IOP or visual field findings, whereas SPARCS and GQL-15 findings significantly varied from baseline, both being improved in subjects treated with CIT/HOMO/VITE fixed combination.","[{'ForeName': 'Pier Franco', 'Initials': 'PF', 'LastName': 'Marino', 'Affiliation': 'Department of Medicine and Health Science ""V. Tiberio"", the University of Molise, 86100 Campobasso, Italy.'}, {'ForeName': 'Gemma Caterina Maria', 'Initials': 'GCM', 'LastName': 'Rossi', 'Affiliation': 'IRCCS San Matteo Polyclinic Foundation, 27100 Pavia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Campagna', 'Affiliation': 'Department of Medical-Surgical Sciences and Translational Medicine, University of Rome ""La Sapienza"", 00185 Rome, Italy.'}, {'ForeName': 'Decio', 'Initials': 'D', 'LastName': 'Capobianco', 'Affiliation': 'Ophthalmology Unit, Perimetry and Glaucoma Clinic, ASL NA1 e CE, 80035 Naples, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Costagliola', 'Affiliation': 'Department of Medicine and Health Science ""V. Tiberio"", the University of Molise, 86100 Campobasso, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of Qualicos Study Group', 'Affiliation': ''}]","Molecules (Basel, Switzerland)",['10.3390/molecules25235614']
2226,33260374,A Randomized Comparison of Non-Channeled Glidescope TM Titanium Versus Channeled KingVision TM Videolaryngoscope for Orotracheal Intubation in Obese Patients with BMI > 35 kg·m -2 .,"Videolaryngoscopes may improve intubating conditions in obese patients. A total of 110 patients with a body mass index > 35 kg∙m -2 were prospectively randomized to tracheal intubation using non-channeled Glidescope Titanium or channeled King Vision videolaryngoscope. The primary outcome was the time to tracheal intubation. Secondary outcomes included: total success rate, number of attempts, the quality of visualization, peri-procedural and post-proceduralcomplications. Time to the first effective breath was shorter with the King Vision (median; 95% CI)-36; 34-39 s vs. 42; 40-50 in the Glidescope group ( p = 0.007). The total success rate was higher in the Glidescope group-100% vs. 89.1% ( p = 0.03). There was a higher incidence of moderate and difficult laryngoscopy in the King Vision group. No difference was recorded in first attempt success rates, total number of attempts, use of additional maneuvers, intraoperative trauma, or any significant decrease in SpO 2 during intubation. No serious complications were noted and the incidence of postoperative complaints was without difference. Although tracheal intubation with King Vision showed shorter time to the first breath, total success was higher in the Glidescope group, and all but one patients where intubation failed with the KingVision were subsequently intubated with the Glidescope.",2020,"No difference was recorded in first attempt success rates, total number of attempts, use of additional maneuvers, intraoperative trauma, or any significant decrease in SpO 2 during intubation.","['110 patients with a body mass index > 35 kg∙m -2', 'obese patients', 'Obese Patients with BMI ', '40-50 in the Glidescope group ']","['tracheal intubation using non-channeled Glidescope Titanium or channeled King Vision videolaryngoscope', 'Channeled Glidescope TM Titanium Versus Channeled KingVision TM Videolaryngoscope']","['total success rate', 'serious complications', 'success rates, total number of attempts, use of additional maneuvers, intraoperative trauma', 'intubating conditions', 'incidence of postoperative complaints', 'time to tracheal intubation', 'shorter time to the first breath, total success', 'total success rate, number of attempts, the quality of visualization, peri-procedural and post-proceduralcomplications']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",110.0,0.162496,"No difference was recorded in first attempt success rates, total number of attempts, use of additional maneuvers, intraoperative trauma, or any significant decrease in SpO 2 during intubation.","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Brozek', 'Affiliation': 'Department of Anaesthesiology and Intensive Medicine, General University Hospital and First Medical Faculty of the Charles University, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bruthans', 'Affiliation': 'Department of Anaesthesiology and Intensive Medicine, General University Hospital and First Medical Faculty of the Charles University, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Porizka', 'Affiliation': 'Department of Anaesthesiology and Intensive Medicine, General University Hospital and First Medical Faculty of the Charles University, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Blaha', 'Affiliation': 'Department of Anaesthesiology and Intensive Medicine, General University Hospital and First Medical Faculty of the Charles University, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Jitka', 'Initials': 'J', 'LastName': 'Ulrichova', 'Affiliation': 'Department of Anaesthesiology and Intensive Medicine, General University Hospital and First Medical Faculty of the Charles University, 128 00 Prague, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Michalek', 'Affiliation': 'Department of Anaesthesiology and Intensive Medicine, General University Hospital and First Medical Faculty of the Charles University, 128 00 Prague, Czech Republic.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10121024']
2227,33260357,Effect of Instability and Bodyweight Neuromuscular Training on Dynamic Balance Control in Active Young Adults.,"The aims of this study were to analyse the effects of unstable and stable bodyweight neuromuscular training on dynamic balance control and to analyse the between-group differences after the training period. Seventy-seven physically active young adults (48 males, 29 females, 19.1 ± 1.1 years, 170.2 ± 9.2 cm, 64.1 ± 10.7 kg) were distributed into an unstable training group (UTG), a stable training group (STG), and a control group (CG). Training was conducted three times a week for nine weeks. Pre-intervention and post-intervention measures included dynamic balance control using a Y Balance Test (YBT), anterior (A), posteromedial (PM), and posterolateral (PL) reach direction. A mixed ANOVA was executed to test the within-subjects factor and the between-subjects factor. Statistically significant differences were found for all YBT measures within groups ( p = 0.01) and between groups ( p = 0.01). After the intervention, UTG and STG presented meaningfully improved results in all YBT measures (A: 7%, p = 0.01; 4%, p = 0.02, PM: 8%, p = 0.01; 5%, p = 0.01, PL: 8%, p = 0.01; 4%, p = 0.04, respectively). No statistical changes were found for any of the measures in the CG. After the intervention, significant differences were observed between the UTG and CG for the YBTA and PM ( p = 0.03; p = 0.01). The results suggest that neuromuscular training using an unstable surface had similar effects on dynamic balance control as training using a stable surface. When compared to CG, UTG showed better performance in YBTA and PM.",2020,The results suggest that neuromuscular training using an unstable surface had similar effects on dynamic balance control as training using a stable surface.,"['Seventy-seven physically active young adults (48 males, 29 females, 19.1 ± 1.1 years, 170.2 ± 9.2 cm, 64.1 ± 10.7 kg', 'Active Young Adults']","['Instability and Bodyweight Neuromuscular Training', 'unstable training group (UTG), a stable training group (STG), and a control group (CG', 'neuromuscular training', 'unstable and stable bodyweight neuromuscular training']","['YBT measures', 'dynamic balance control using a Y Balance Test (YBT), anterior (A), posteromedial (PM), and posterolateral (PL) reach direction', 'Dynamic Balance Control']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",77.0,0.0161662,The results suggest that neuromuscular training using an unstable surface had similar effects on dynamic balance control as training using a stable surface.,"[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Gonçalves', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus A Xunqueira, Pontevedra, 36005 Pontevedra, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Bezerra', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Vila-Chã', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences & Human Development, CIDESD, 5001-801 Vila Real, Portugal.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Leão', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Brandão', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347 Viana do Castelo, Portugal.""}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Cancela', 'Affiliation': 'Faculty of Education and Sport Sciences, University of Vigo, Campus A Xunqueira, Pontevedra, 36005 Pontevedra, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17238879']
2228,33260274,A pilot trial of moderated online social therapy for family and friends of young people with borderline personality disorder features.,"AIM
We evaluated the acceptability, usability and safety of Kindred, a novel online intervention for carers of young people with borderline personality disorder (BPD) using a pre-post pilot trial design. The secondary aim explored whether Kindred use was associated with clinical improvements for caregivers on measures of burden of caregiving, stress, expressed emotion, family communication, disability, coping and knowledge of BPD and for patients on measures of severity of BPD symptoms and level of functional impairment.
METHODS
The trial site was the Helping Young People Early program for young people with BPD at Orygen in Melbourne, Australia. Informed consent was obtained from 20 adult carers (i.e., relatives or friends) and 10 young people aged 15-25 with BPD. Kindred, which was available for 3 months, incorporated online psychoeducation, carer-to-carer social networking and guidance from expert and peer moderators. Assessments were completed at baseline and 3 months follow-up. Multiple indicators of acceptability, usability and safety were utilized.
RESULTS
Seventeen carers were enrolled in Kindred and eight young people completed baseline measures. A priori acceptability, usability and safety criteria were met. Carer burden, stress, expressed emotion, family communication, quality of life, functioning, coping and perceived knowledge of BPD improved at follow-up. Sixty-six percent of the young people (4/6) reported that they believed Kindred had improved their carers' understanding of BPD.
CONCLUSION
Kindred was shown to be acceptable, usable and safe, with encouraging improvements in both carer and young person outcomes. Kindred warrants evaluation of its efficacy via an randomized controlled trial.",2020,"AIM
We evaluated the acceptability, usability and safety of Kindred, a novel online intervention for carers of young people with borderline personality disorder (BPD) using a pre-post pilot trial design.","['20 adult carers (i.e., relatives or friends) and 10 young people aged 15-25 with BPD', 'carers of young people with borderline personality disorder (BPD', 'Seventeen carers', 'young people with BPD at Orygen in Melbourne, Australia', 'family and friends of young people with borderline personality disorder features']","['novel online intervention', 'moderated online social therapy']","['Carer burden, stress, expressed emotion, family communication, quality of life, functioning, coping and perceived knowledge of BPD', 'acceptability, usability and safety', 'burden of caregiving, stress, expressed emotion, family communication, disability, coping and knowledge of BPD', 'BPD symptoms and level of functional impairment']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0740117', 'cui_str': 'Social therapy'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",17.0,0.0815951,"AIM
We evaluated the acceptability, usability and safety of Kindred, a novel online intervention for carers of young people with borderline personality disorder (BPD) using a pre-post pilot trial design.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Betts', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCutcheon', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Jovev', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Reeva', 'Initials': 'R', 'LastName': 'Lederman', 'Affiliation': 'School of Computing and Information Systems, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Herrman', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'McKechnie', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Burke', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Koval', 'Affiliation': 'Melbourne School of Psychological Sciences, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': ""D'Alfonso"", 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Sumudu', 'Initials': 'S', 'LastName': 'Mallawaarachchi', 'Affiliation': 'Orygen, Melbourne, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Chanen', 'Affiliation': 'Orygen, Melbourne, Australia.'}]",Early intervention in psychiatry,['10.1111/eip.13094']
2229,33260253,Effects of commercial metronidazole and metronidazole benzoate suspensions on food intake in chinchillas.,"OBJECTIVES
To evaluate if commercially available metronidazole and metronidazole benzoate suspensions cause a reduction in food intake in healthy chinchillas and if the reduction in food intake is dose-dependent.
MATERIALS AND METHODS
Twelve chinchillas were used in a randomised, controlled, blinded, complete-crossover study. All treatments were administered orally every 12 hours for 3 days. Metronidazole (125 mg/mL) was administered at 20 mg/kg and metronidazole benzoate (25 mg/mL) was administered at 20 and 10 mg/kg. Food intake was recorded daily. The washout period between treatments was at least 14 days.
RESULTS
At 20 mg/kg PO q12h administration of both commercial suspensions resulted in a significant reduction of food intake. The greatest mean reduction in food intake occurred after 2 to 3 days of drug administration (metronidazole: -54 ± 25%; metronidazole benzoate: -44 ± 36%). After administration of metronidazole benzoate at 10 mg/kg PO q12h, the reduction in food intake was significantly less pronounced (-24 ± 36%), suggesting that negative effect of metronidazole on food intake in chinchillas is dose-dependent. Variation in metronidazole-induced food intake reduction differed widely between individual chinchillas.
CLINICAL SIGNIFICANCE
The oral administration of commercial metronidazole and metronidazole benzoate suspensions results in a dose-dependent clinically relevant reduction in food intake in chinchillas. Metronidazole should be used cautiously in this species and food intake should be monitored during treatment. Future studies are needed in order to determine if metronidazole at 10 mg/kg q12h is an effective therapeutic dosage in chinchillas.",2020,At 20 mg/kg PO q12h administration of both commercial suspensions resulted in a significant reduction of food intake.,"['food intake in chinchillas', 'chinchillas']","['metronidazole', 'commercial metronidazole and metronidazole benzoate suspensions', 'metronidazole benzoate', 'Metronidazole', 'metronidazole and metronidazole benzoate suspensions']","['Food intake', 'food intake']","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0008119', 'cui_str': 'Genus Chinchilla'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0353490', 'cui_str': 'Metronidazole benzoate'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}]",12.0,0.0476973,At 20 mg/kg PO q12h administration of both commercial suspensions resulted in a significant reduction of food intake.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mans', 'Affiliation': 'School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI, 53706, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'School of Veterinary Medicine, University of Wisconsin-Madison, 2015 Linden Drive, Madison, WI, 53706, USA.'}]",The Journal of small animal practice,['10.1111/jsap.13276']
2230,33260212,Impact of digitally acquired peer diagnostic input on diagnostic confidence in outpatient cases: A pragmatic randomized trial.,"OBJECTIVE
The study sought to evaluate if peer input on outpatient cases impacted diagnostic confidence.
MATERIALS AND METHODS
This randomized trial of a peer input intervention occurred among 28 clinicians with case-level randomization. Encounters with diagnostic uncertainty were entered onto a digital platform to collect input from ≥5 clinicians. The primary outcome was diagnostic confidence. We used mixed-effects logistic regression analyses to assess for intervention impact on diagnostic confidence.
RESULTS
Among the 509 cases (255 control; 254 intervention), the intervention did not impact confidence (odds ratio [OR], 1.46; 95% confidence interval [CI], 0.999-2.12), but after adjusting for clinician and case traits, the intervention was associated with higher confidence (OR, 1.53; 95% CI, 1.01-2.32). The intervention impact was greater in cases with high uncertainty (OR, 3.23; 95% CI, 1.09- 9.52).
CONCLUSIONS
Peer input increased diagnostic confidence primarily in high-uncertainty cases, consistent with findings that clinicians desire input primarily in cases with continued uncertainty.",2020,"The intervention impact was greater in cases with high uncertainty (OR, 3.23; 95% CI, 1.09- 9.52).
","['Encounters with diagnostic uncertainty', '28 clinicians with case-level randomization', 'outpatient cases']","['digitally acquired peer diagnostic input', 'peer input intervention']",['diagnostic confidence'],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.13942,"The intervention impact was greater in cases with high uncertainty (OR, 3.23; 95% CI, 1.09- 9.52).
","[{'ForeName': 'Elaine C', 'Initials': 'EC', 'LastName': 'Khoong', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valy', 'Initials': 'V', 'LastName': 'Fontil', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Natalie A', 'Initials': 'NA', 'LastName': 'Rivadeneira', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Mekhala', 'Initials': 'M', 'LastName': 'Hoskote', 'Affiliation': 'Berkeley School of Public Health and UCSF School of Medicine, University of California, Berkeley-University of California, San Francisco Joint Medical Program, Berkeley, California, USA.'}, {'ForeName': 'Shantanu', 'Initials': 'S', 'LastName': 'Nundy', 'Affiliation': 'Milken Institute School of Public Health, Department of Health Policy and Management, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Lyles', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'Division of General Internal Medicine, Zuckerberg San Francisco General Hospital, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocaa278']
2231,33260203,The Effectiveness of Dorsal Root Ganglion Neurostimulation for the Treatment of Chronic Pelvic Pain and Chronic Neuropathic Pain of the Lower Extremity: A Comprehensive Review of the Published Data.,"OBJECTIVE
To evaluate the effectiveness of dorsal root ganglion neurostimulation for the treatment of refractory, focal pain in the pelvis and lower extremities.
DESIGN
Systematic review.
OUTCOME MEASURES
The primary outcome was ≥50% pain relief. Secondary outcomes were physical function, mood, quality of life, opioid usage, and complications.
RESULTS
One pragmatic randomized controlled trial, four prospective cohort studies, and eight case series met the inclusion criteria. A worst-case scenario analysis from the randomized controlled trial reported ≥50% pain relief in 74% of patients with dorsal root ganglion neurostimulation vs. 51% of patients who experienced at least 50% relief with spinal cord stimulation at 3 months. Cohort data success rates ranged from 43% to 83% at ≤6 months and 27% to 100% at >6 months. Significant improvements were also reported in the secondary outcomes assessed, including mood, quality of life, opioid usage, and health care utilization, though a lack of available quantitative data limits further statistical analysis. Complication rates vary, though the only randomized controlled trial reported a higher rate of adverse events than that seen with traditional neurostimulation.
CONCLUSIONS
In accordance with the Grades of Recommendation, Assessment, Development, and Evaluation system, low-quality evidence supports dorsal root ganglion neurostimulation as a more effective treatment than traditional neurostimulation for pain and dysfunction associated with complex regional pain syndrome or causalgia. Very low-quality evidence supports dorsal root ganglion neurostimulation for the treatment of chronic pelvic pain, chronic neuropathic groin pain, phantom limb pain, chronic neuropathic pain of the trunk and/or limbs, and diabetic neuropathy.",2020,"Significant improvements were also reported in the secondary outcomes assessed, including mood, quality of life, opioid usage, and health care utilization, though a lack of available quantitative data limits further statistical analysis.",['of the Lower Extremity'],"['Dorsal Root Ganglion Neurostimulation', 'dorsal root ganglion neurostimulation']","['pain relief', 'Complication rates', '≥50% pain relief', 'mood, quality of life, opioid usage, and health care utilization', 'rate of adverse events', 'physical function, mood, quality of life, opioid usage, and complications', 'Chronic Pelvic Pain and Chronic Neuropathic Pain']","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]","[{'cui': 'C0017070', 'cui_str': 'Structure of spinal nerve ganglion'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation procedure'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}]",,0.134085,"Significant improvements were also reported in the secondary outcomes assessed, including mood, quality of life, opioid usage, and health care utilization, though a lack of available quantitative data limits further statistical analysis.","[{'ForeName': 'Ameet', 'Initials': 'A', 'LastName': 'Nagpal', 'Affiliation': 'Department of Anesthesiology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Clements', 'Affiliation': 'Department of Rehabilitation Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Duszynski', 'Affiliation': 'Spine Intervention Society, Hinsdale, Illinois, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Boies', 'Affiliation': 'Department of Anesthesiology, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa369']
2232,33260196,Participation in a Yoga Study Decreases Stress and Depression Scores for Incarcerated Women.,"Incarcerated individuals exhibit a high incidence of stress-related disorders, including addiction and posttraumatic stress disorder (PTSD), as well as the added stress of captivity. Access to stress-reduction tools is limited for these individuals. One possible approach may be regular structured yoga classes. Using two approaches, we tested the effectiveness of a brief, intensive yoga intervention in a population of incarcerated women in a county jail. The first approach was an examination of archival data collected as part of a program analysis. Individuals showed considerable reduction in self-reported stress following a single yoga session. The second approach was an experimental study using a week-long yoga intervention. Thirty-four participants were assigned to either the yoga or control group for the first week. In the second week, the conditions were reversed. Participants were assessed weekly, before and after intervention. Baseline scores revealed high rates of depression, stress, and exposure to traumatic life events compared to normative data. Stress and depression were assessed using the Perceived Stress Scale and Beck Depression Inventory, respectively. Compared to controls, participants reported less depression after a week of daily yoga sessions. Perceived stress declined under both control and yoga conditions. Due to the transient nature of the jail institution, it is important to examine interventions that can be provided on a short-term basis. Although there were limitations in this study, the results support the conclusion that the brief yoga intervention had a positive effect on participants' well-being.",2020,Perceived stress declined under both control and yoga conditions.,"['Incarcerated Women', 'population of incarcerated women in a county jail']",['intensive yoga intervention'],"['Perceived Stress Scale and Beck Depression Inventory', 'rates of depression, stress, and exposure to traumatic life events', 'Stress and depression', 'Stress and Depression Scores']","[{'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",34.0,0.0154189,Perceived stress declined under both control and yoga conditions.,"[{'ForeName': 'Traci H', 'Initials': 'TH', 'LastName': 'Lundstrom', 'Affiliation': 'Department of Psychological Sciences, Metropolitan State University of Denver, Colo.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Rocheleau', 'Affiliation': 'Department of Psychological Sciences, Metropolitan State University of Denver, Colo.'}, {'ForeName': 'Dimpna Flores', 'Initials': 'DF', 'LastName': 'Guerra', 'Affiliation': 'Department of Psychological Sciences, Metropolitan State University of Denver, Colo.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychological Sciences, Metropolitan State University of Denver, Colo.'}]",International journal of yoga therapy,['10.17761/2021-D-19-00064']
2233,33260183,Efficacy of an Oxycodone-Propofol Combination versus a Fentanyl-Propofol Combination in Conscious Sedation during Therapeutic Endoscopic Retrograde Cholangiopancreatography in Elderly Patients.,"BACKGROUND
With a rapidly aging population, the need for endoscopic retrograde cholangiopancreatography (ERCP) is increasing. The commonly used sedation anesthesia in ERCP is a combination of propofol and fentanyl, even though fentanyl may cause some adverse reactions such as respiratory depression.
OBJECTIVES
This study aimed to evaluate the efficacy of oxycodone combined with propofol versus fentanyl combined with propofol for sedation anesthesia during ERCP.
METHODS
A total of 193 patients aged from 65 to 80 years undergoing ERCP were enrolled and randomized into two groups: an ""oxycodone combined with propofol"" group (group OP, n = 97) and a ""fentanyl combined with propofol"" group (group FP, n = 96). The rate of perioperative adverse events as well as the recovery time, patients' satisfaction, and endoscopists' satisfaction were noted.
RESULTS
There was no difference in the frequency of hypotension or bradycardia between the two groups, but there were more episodes of desaturation (SpO2 <90% for >10 s in 8.3%), postoperative nausea (7.3%), and vomiting (5.2%) in group FP than in group OP. Patients' satisfaction in group FP was lower than that in group OP. The recovery time was longer in group FP than in group OP.
CONCLUSIONS
Oxycodone combined with propofol was effective in ERCP, with a low incidence of perioperative adverse events.",2020,"The rate of perioperative adverse events as well as the recovery time, patients' satisfaction, and endoscopists' satisfaction were noted.
","['Elderly Patients', '193 patients aged from 65 to 80 years undergoing ERCP']","['propofol versus fentanyl combined with propofol', 'propofol and fentanyl', 'oxycodone combined with propofol"" group', 'oxycodone', 'Oxycodone combined with propofol', 'Oxycodone-Propofol Combination', 'endoscopic retrograde cholangiopancreatography (ERCP', 'fentanyl combined with propofol"" group', 'Fentanyl-Propofol Combination']","['vomiting', ""recovery time, patients' satisfaction, and endoscopists' satisfaction"", 'postoperative nausea', 'recovery time', 'rate of perioperative adverse events', 'episodes of desaturation', 'frequency of hypotension or bradycardia']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}]",193.0,0.027417,"The rate of perioperative adverse events as well as the recovery time, patients' satisfaction, and endoscopists' satisfaction were noted.
","[{'ForeName': 'Peipei', 'Initials': 'P', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Huisheng', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Zhongnan Hospital of Wuhan University, Wuhan, China, wb001428@whu.edu.cn.'}]",Gerontology,['10.1159/000511173']
2234,33260144,The Effects of Low-Intensity Multimodal Proprioceptive Exercise on Cognitive Function in Older Adults.,"BACKGROUND
Physical activity provides a number of physical and psychological benefits. Multimodal proprioceptive exercise represents a useful balance-based exercise with the potential to reduce falls in older adults. Previous research has also indicated cognitive benefits following multimodal proprioceptive exercise in young and older adults. This study aimed to assess cognition and mood following 2 types of physical activity (multimodal proprioception vs yoga) compared with control (classroom-based) in healthy older adults.
METHOD
Nineteen older adults (Mage = 65, sex = 9 males) participated in this randomized controlled crossover trial. Participants completed a 20-minute multimodal proprioceptive exercise class, 20-minute yoga session, and 20-minute classroom-based control. Numeric working memory and mood were assessed before and immediately following each of the interventions.
RESULTS
The multimodal proprioceptive intervention significantly reduced numeric working memory reaction time versus the yoga (P = .043) and control (P = .023) group. There were no differences found for accuracy or mood.
CONCLUSIONS
These results indicate that multimodal proprioceptive exercise is worthy of further investigation as an alternative mode of exercise alongside the more traditional aerobic and strength-based exercise for healthy older adults.",2020,The multimodal proprioceptive intervention significantly reduced numeric working memory reaction time versus the yoga (P = .043) and control (P = .023) group.,"['older adults', 'Nineteen older adults (Mage = 65, sex = 9 males', 'Older Adults', 'healthy older adults', 'young and older adults']","['multimodal proprioceptive intervention', 'Multimodal proprioceptive exercise', 'control (classroom-based', 'multimodal proprioceptive exercise', 'Low-Intensity Multimodal Proprioceptive Exercise', '20-minute multimodal proprioceptive exercise class, 20-minute yoga session, and 20-minute classroom-based control', 'physical activity (multimodal proprioception vs yoga']","['Cognitive Function', 'accuracy or mood', 'numeric working memory reaction time', 'Numeric working memory and mood']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0454280', 'cui_str': 'Proprioceptive exercises'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",19.0,0.0298817,The multimodal proprioceptive intervention significantly reduced numeric working memory reaction time versus the yoga (P = .043) and control (P = .023) group.,"[{'ForeName': 'Spencer E', 'Initials': 'SE', 'LastName': 'Boyle', 'Affiliation': ''}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Fothergill', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Metcalfe', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Docherty', 'Affiliation': ''}, {'ForeName': 'Crystal F', 'Initials': 'CF', 'LastName': 'Haskell-Ramsay', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2020-0134']
2235,33260142,"Quinine Ingestion During the Latter Stages of a 3,000-m Time Trial Fails to Improve Cycling Performance.","The ingestion of quinine, a bitter tastant, improves short-term (30 s) cycling performance, but it is unclear whether this effect can be integrated into the last effort of a longer race. The purpose of this study was to determine whether midtrial quinine ingestion improves 3,000-m cycling time-trial (TT) performance. Following three familiarization TTs, 12 well-trained male cyclists (mean ± SD: mass = 76.6 ± 9.2 kg, maximal aerobic power = 390 ± 50 W, maximal oxygen uptake = 4.7 ± 0.6 L/min) performed four experimental 3,000-m TTs on consecutive days. This double-blind, crossover design study had four randomized and counterbalanced conditions: (a) Quinine 1 (25-ml solution, 2 mM of quinine); (b) Quinine 2, replicate of Quinine 1; (c) a 25-ml sweet-tasting no-carbohydrate solution (Placebo); and (d) 25 ml of water (Control) consumed at the 1,850-m point of the TT. The participants completed a series of perceptual scales at the start and completion of all TTs, and the power output was monitored continuously throughout all trials. The power output for the last 1,000 m for all four conditions was similar: mean ± SD: Quinine 1 = 360 ± 63 W, Quinine 2 = 367 ± 63 W, Placebo = 364 ± 64 W, and Control = 367 ± 58 W. There were also no differences in the 3,000-m TT power output between conditions. The small perceptual differences between trials at specific 150-m splits were not explained by quinine intake. Ingesting 2 mM of quinine during the last stage of a 3,000-m TT did not improve cycling performance.",2020,"The ingestion of quinine, a bitter tastant, improves short-term (30 s) cycling performance, but it is unclear whether this effect can be integrated into the last effort of a longer race.","['12 well-trained male cyclists (mean ± SD: mass = 76.6 ± 9.2\xa0kg, maximal aerobic power = 390 ± 50\xa0W, maximal oxygen uptake = 4.7 ± 0.6\xa0L/min) performed four experimental 3,000-m TTs on consecutive days']","['midtrial quinine ingestion', 'Quinine 1 (25-ml solution, 2\xa0mM of quinine); (b)\xa0Quinine 2, replicate of Quinine 1; (c)\xa0a 25-ml sweet-tasting no-carbohydrate solution (Placebo); and (d)\xa025', 'ml of water (Control', 'Quinine Ingestion']","['cycling performance', '3,000-m cycling time-trial (TT) performance']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0034417', 'cui_str': 'Quinine'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",,0.459742,"The ingestion of quinine, a bitter tastant, improves short-term (30 s) cycling performance, but it is unclear whether this effect can be integrated into the last effort of a longer race.","[{'ForeName': 'Naroa', 'Initials': 'N', 'LastName': 'Etxebarria', 'Affiliation': 'University of Canberra.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Clark', 'Affiliation': 'University of Canberra.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Ross', 'Affiliation': 'Australian Institute of Sport.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hui', 'Affiliation': 'Concentra.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Goecke', 'Affiliation': 'University of Canberra.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rattray', 'Affiliation': 'University of Canberra.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Burke', 'Affiliation': 'Australian Institute of Sport.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0265']
2236,33260141,Habitual Caffeine Consumption Does Not Affect the Ergogenicity of Coffee Ingestion During a 5 km Cycling Time Trial.,"There is growing evidence that caffeine and coffee ingestion prior to exercise provide similar ergogenic benefits. However, there has been a long-standing paradigm that habitual caffeine intake may influence the ergogenicity of caffeine supplementation. The aim of the present study was to investigate the effect of habitual caffeine intake on 5-km cycling time-trial performance following the ingestion of caffeinated coffee. Following institutional ethical approval, in a double-blind, randomized, crossover, placebo-controlled design, 46 recreationally active participants (27 men and 19 women) completed a 5-km cycling time trial on a cycle ergometer 60 m in following the ingestion of 0.09 g/kg coffee providing 3 mg/kg of caffeine, or a placebo. Habitual caffeine consumption was assessed using a caffeine consumption questionnaire with low habitual caffeine consumption defined as <3 and ≥6 mg · kg-1 · day-1 defined as high. An analysis of covariance using habitual caffeine intake as a covariant was performed to establish if habitual caffeine consumption had an impact on the ergogenic effect of coffee ingestion. Sixteen participants were classified as high-caffeine users and 30 as low. Ingesting caffeinated coffee improved 5-km cycling time-trial performance by 8 ± 12 s; 95% confidence interval (CI) [5, 13]; p < .001; d = 0.30, with low, 9±14 s; 95% CI [3, 14]; p = .002; d = 0.18, and high, 8 ± 10 s; 95% CI [-1, 17]; p = .008; d = 0.06, users improving by a similar magnitude, 95% CI [-12, 12]; p = .946; d = 0.08. In conclusion, habitual caffeine consumption did not affect the ergogenicity of coffee ingestion prior to a 5-km cycling time trial.",2020,"Ingesting caffeinated coffee improved 5-km cycling time-trial performance by 8 ± 12 s; 95% confidence interval (CI) [5, 13]; p < .001;","['Sixteen participants were classified as high-caffeine users and 30 as low', '46 recreationally active participants (27 men and 19 women']","['caffeine', 'placebo', 'caffeinated coffee', 'habitual caffeine intake', 'cycle ergometer 60\xa0m in following the ingestion of 0.09\xa0g/kg coffee providing 3\xa0mg/kg of caffeine, or a placebo']","['Habitual caffeine consumption', '5-km cycling time-trial performance', 'ergogenicity of coffee ingestion', 'Ergogenicity of Coffee Ingestion']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0861097', 'cui_str': 'Caffeine increased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]",16.0,0.554346,"Ingesting caffeinated coffee improved 5-km cycling time-trial performance by 8 ± 12 s; 95% confidence interval (CI) [5, 13]; p < .001;","[{'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Clarke', 'Affiliation': 'Coventry University.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Richardson', 'Affiliation': 'Coventry University.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0204']
2237,33260139,L-Arginin Improves Endurance to High-Intensity Interval Exerices in Overweight Men.,"The effects of acute consumption of L-Arginine (L-Arg) in healthy young individuals are not clearly defined, and no studies on the effects of L-Arg in individuals with abnormal body mass index undertaking strenuous exercise exist. Thus, we examined whether supplementation with L-Arg diminishes cardiopulmonary exercise testing responses, such as ventilation (VE), VE/VCO2, oxygen uptake (VO2), and heart rate, in response to an acute session of high-intensity interval exercise (HIIE) in overweight men. A double-blind, randomized crossover design was used to study 30 overweight men (age, 26.5 ± 2.2 years; body weight, 88.2 ± 5.3 kilogram; body mass index, 28.0 ± 1.4 kg/m2). Participants first completed a ramped-treadmill exercise protocol to determine VO2max velocity (vVO2max), after which they participated in two sessions of HIIE. Participants were randomly assigned to receive either 6 g of L-Arg or placebo supplements. The HIIE treadmill running protocol consisted of 12 trials, including exercise at 100% of vVO2max for 1 min interspersed with recovery intervals of 40% of vVO2max for 2 min. Measurements of VO2 (ml·kg-1·min-1), VE (L/min), heart rate (beat per min), and VE/VCO2 were obtained. Supplementation with L-Arg significantly decreased all cardiorespiratory responses during HIIE (placebo+HIIE vs. L-Arg+HIIE for each measurement: VE [80.9 ± 4.3 L/min vs. 74.6 ± 3.5 L/min, p < .05, ES = 1.61], VE/VCO2 [26.4 ± 1.3 vs. 24.4 ± 1.0, p < .05, ES = 1.8], VO2 [26.4 ± 0.8 ml·kg-1·min-1 vs. 24.4 ± 0.9 ml·kg-1·min-1, p < .05, ES = 2.2], and heart rate [159.7 ± 6.3 beats/min vs. 155.0 ± 3.7 beats/min, p < .05, d = 0.89]). The authors conclude consuming L-Arg before HIIE can alleviate the excessive physiological strain resulting from HIIE and help to increase exercise tolerance in participants with a higher body mass index who may need to exercise on a regular basis for extended periods to improve their health.",2020,"Supplementation with L-Arg significantly decreased all cardiorespiratory responses during HIIE (placebo+HIIE vs. L-Arg+HIIE for each measurement: VE [80.9 ± 4.3 L/min vs. 74.6 ± 3.5 L/min, p","['Overweight Men', 'overweight men', '30 overweight men (age, 26.5 ± 2.2\xa0years; body weight, 88.2 ± 5.3\xa0kilogram; body mass index, 28.0 ± 1.4\xa0kg/m2', 'healthy young individuals']","['L-Arginin', 'L-Arginine (L-Arg', '6\xa0g of L-Arg or placebo supplements', 'ramped-treadmill exercise protocol to determine VO2max velocity (vVO2max', 'high-intensity interval exercise (HIIE']","['Measurements of VO2 (ml·kg-1·min-1), VE (L/min), heart rate (beat per min), and VE/VCO2', 'exercise tolerance', 'cardiopulmonary exercise testing responses, such as ventilation (VE), VE/VCO2, oxygen uptake (VO2), and heart rate', 'heart rate', 'cardiorespiratory responses']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0034646', 'cui_str': 'Ramp'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]",30.0,0.263013,"Supplementation with L-Arg significantly decreased all cardiorespiratory responses during HIIE (placebo+HIIE vs. L-Arg+HIIE for each measurement: VE [80.9 ± 4.3 L/min vs. 74.6 ± 3.5 L/min, p","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Daraei', 'Affiliation': 'Shahid Beheshti University.'}, {'ForeName': 'Sajad', 'Initials': 'S', 'LastName': 'Ahmadizad', 'Affiliation': 'Shahid Beheshti University.'}, {'ForeName': 'Hiwa', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Shahid Beheshti University.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Johnson', 'Affiliation': 'Coastal Carolina University.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Laher', 'Affiliation': 'University of British Columbia.'}, {'ForeName': 'Ayoub', 'Initials': 'A', 'LastName': 'Saeidi', 'Affiliation': 'Islamic Azad University.'}, {'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Zouhal', 'Affiliation': 'Université Rennes 2.'}]",International journal of sport nutrition and exercise metabolism,['10.1123/ijsnem.2020-0054']
2238,33260076,"Transcranial direct current stimulation of dorsolateral prefrontal cortex improves dual-task gait performance in patients with Parkinson's disease: A double blind, sham-controlled study.","BACKGROUND
Despite advances in pharmacological treatments and surgical processes, the problem of impaired dual-tasking persists in people with Parkinson's disease (PD). Recently, transcranial direct current stimulation (tDCS) applied to the dorsolateral prefrontal cortex (DLPFC) has shown the potential to improve dual-task walking.
RESEARCH QUESTION
Can combining left DLPFC stimulation using tDCS with dual-task performance reduce the cost of dual-tasking in individuals with PD?
METHODS
We conducted a sham-controlled, cross-over, and double-blind study to investigate the effect of combining tDCS with the dual-task walk and its sustained effects among people with PD. Twenty participants with PD completed two sessions (anodal or sham tDCS) with at least a 1-week gap. Stimulation involved transferring 2 mA current through the left DLPFC for 30 min. Single- and dual-task gait was assessed before, during, immediately after, 15, and 30 min after stimulation ceased. Phoneme verbal fluency task was given as the cognitive distractor during dual task.
RESULTS AND CONCLUSION
The results of this study show that in the dual-task condition, participants walked faster at fifteen minutes (p = 0.017) and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham. Similarly, participants generated a higher number of words per minute at fifteen minutes (p = 0.017), and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham. Furthermore, the dual-task cost (DTC) associated with gait speed was significantly lower (p = 0.022) at fifteen minutes after anodal tDCS compared to sham tDCS. However, no significant effect of tDCS was observed on gait and cognitive performance under the single-task condition. In conclusion, left DLPFC stimulation can improve dual-tasking in participants with PD and the peaking of the tDCS effect was observed at fifteen minutes after stimulation ceased.",2020,"Similarly, participants generated a higher number of words per minute at fifteen minutes (p = 0.017), and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham.","['individuals with PD', ""patients with Parkinson's disease"", ""people with Parkinson's disease (PD"", 'people with PD', 'Twenty participants with PD completed two']","['transcranial direct current stimulation (tDCS', 'tDCS', 'Transcranial direct current stimulation of dorsolateral prefrontal cortex', 'anodal tDCS', 'sessions (anodal or sham tDCS']","['tDCS effect', 'dual-task gait performance', 'gait and cognitive performance', 'cost of dual-tasking', 'Phoneme verbal fluency task', 'Single- and dual-task gait', 'dual-task cost (DTC) associated with gait speed', 'higher number of words per minute']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0702093', 'cui_str': '/minute'}]",20.0,0.051601,"Similarly, participants generated a higher number of words per minute at fifteen minutes (p = 0.017), and thirty minutes (p < 0.01) after anodal tDCS ceased compared to sham.","[{'ForeName': 'Ram Kinker', 'Initials': 'RK', 'LastName': 'Mishra', 'Affiliation': 'Center for Neuromotor and Biomechanics Research, University of Houston, TX, USA. Electronic address: rmishra2@uh.edu.'}, {'ForeName': 'Adam T', 'Initials': 'AT', 'LastName': 'Thrasher', 'Affiliation': 'Center for Neuromotor and Biomechanics Research, University of Houston, TX, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.11.012']
2239,33260064,Efficacy and safety of Chinese herbal medicine versus Lopinavir-Ritonavir in adult patients with coronavirus disease 2019: A non-randomized controlled trial.,"BACKGROUND
Treatments for coronavirus disease 2019 (COVID-19) are limited by suboptimal efficacy.
METHODS
From January 30, 2020 to March 23, 2020, we conducted a non-randomised controlled trial, in which all adult patients with laboratory-confirmed COVID-19 were assigned to three groups non-randomly and given supportive treatments: Group A, Lopinavir-Ritonavir; Group B, Huashi Baidu Formula (a Chinese medicineformula made by the China Academy of Chinese Medical Sciences to treat COVID-19, which is now in the clinical trial period) and Lopinavir-Ritonavir; and Group C, Huashi Baidu Formula. The use of antibiotics, antiviruses, and corticosteroids was permitted in Group A and B. Traditional Chinese medicine injections were permitted in Group C. The primary outcomes were clinical remission time (interval from admission to the first time the patient tested negatively for novel coronavirus or an obvious improvement was observed from chest CT) and clinical remission rate (number of patients whose clinical time was within 16 days/total number of patients).
RESULTS
A total of 60 adult patients with COVID-19 were enrolled at sites in Wuhan, China, and the sample size of each group was 20. In Groups A, B and C, the clinical remission rates were 95.0%%(19/20), 100.0%%(20/20) and 100.0%%(20/20), respectively. Compared with Groups A and B, the clinical remission time of Group C was significantly shorter (5.9 days vs. 10.8 days, p < 0.05; 5.9 days vs. 9.7 days, p < 0.05). There was no significant difference among Groups A, B, and C in terms of the time taken to be released from quarantine. The clinical biochemical indicators and safety indexes showed no significant differences among the three groups.
CONCLUSIONS
Our findings suggest that Lopinavir-Ritonavir has some efficacy in the treatment of COVID-19, and the Huashi Baidu Formula might enhance this effect to an extent. In addition, superiority was displayed in the treatment of COVID-19 through a combination of the Huashi Baidu Formula and traditional Chinese medicine injection. In future, well-designed prospective double-blinded randomised control trials are required to confirm our findings.",2020,"In Groups A, B and C, the clinical remission rates were 95.0%%(19/20), 100.0%%(20/20) and 100.0%%(20/20), respectively.","['adult patients with laboratory-confirmed COVID-19', 'adult patients with coronavirus disease 2019', '60 adult patients with COVID-19 were enrolled at sites in Wuhan, China, and the sample size of each group was 20']","['Chinese herbal medicine versus Lopinavir-Ritonavir', 'Lopinavir-Ritonavir', 'Huashi Baidu Formula']","['clinical remission time', 'Efficacy and safety', 'clinical remission time (interval from admission to the first time the patient tested negatively for novel coronavirus or an obvious improvement was observed from chest CT) and clinical remission rate']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}]",60.0,0.237507,"In Groups A, B and C, the clinical remission rates were 95.0%%(19/20), 100.0%%(20/20) and 100.0%%(20/20), respectively.","[{'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Shi', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Lanping', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Bian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Renbo', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Cong', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Guoju', 'Initials': 'G', 'LastName': 'Dong', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Luxing', 'Initials': 'L', 'LastName': 'Leng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Dongxu', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Lv', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Miao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Wensheng', 'Initials': 'W', 'LastName': 'Qi', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Jiaheng', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Huaxin', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Xian', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Yibai', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Haoning', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Luqi', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'China Academy of Chinese Medical Sciences, Beijing 100700, China. Electronic address: Huangluqi01@126.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153367']
2240,33260063,"Switching from originator recombinant growth hormone (Genotropin™) to biosimilar (CRISCY™): Results from a 6-month, multicentric, non-inferiority, extension trial.","OBJECTIVE
A previous 12-month comparative trial with Criscy™ (r-hGH Cristália), a biosimilar recombinant growth hormone, demonstrated equivalent efficacy and safety to Genotropin™. This extension trial evaluated the effects of switching patients treated with Genotropin™ to the biosimilar Criscy™ over an additional 6-month treatment period, comparing efficacy, safety, and immunogenicity parameters with patients remaining in the Criscy™ arm.
DESIGN
This extension study included 11 research centers and 81 patients who participated in the CERES study (Czepielewski et al., 2019 [1]). Participants from the Genotropin™ arm (n = 39) had the drug replaced by Criscy™ and the remaining participants were kept in the Criscy™ arm (n = 42) for an additional 6-month period to evaluate immunogenicity, efficacy (growth rate, height SDS), and safety (laboratory tests, and adverse events).
RESULTS
Before the switch, both Criscy™ and Genotropin groups were similar concerning demographics, and auxological measures: age, sex, height, height SDS, weight, and BMI. Height velocity (HV) after 18 months of treatment was 8.7 ± 1.56 cm/year for Criscy™ group and 8.9 ± 1.36 cm/year for Genotropin™ group in the ITT population (p = 0.43). The auxological parameters and IGF-1 and IGFBP-3 SDS were comparable between both groups of patients. No participants were excluded from the study due to adverse events. There were no clinical or statistical relevant differences between the treatment groups concerning frequency, distribution, intensity, and AEs outcome. Similarly, no new anti-r-hGH (ADA) cases among patients that switched from Genotropin™ to Criscy™ were reported. No neutralizing antibody (nAb) was detected in either group.
CONCLUSIONS
This trial showed that switching from originator recombinant human growth hormone to Criscy™ had no impact on efficacy, safety, nor immunogenicity as compared to continued treatment with Criscy™. Growth rates and ADA incidence remained the same as seen before the switch.",2020,"Before the switch, both Criscy™ and Genotropin groups were similar concerning demographics, and auxological measures: age, sex, height, height SDS, weight, and BMI.","['11 research centers and 81 patients who participated in the CERES study (Czepielewski et al', 'patients remaining in the Criscy™ arm']","['Genotropin', 'Switching from originator recombinant growth hormone (Genotropin™) to biosimilar (CRISCY™']","['efficacy, safety, and immunogenicity parameters', 'immunogenicity, efficacy (growth rate, height SDS), and safety (laboratory tests, and adverse events', 'Height velocity (HV', 'neutralizing antibody (nAb', 'Growth rates and ADA incidence', 'efficacy, safety, nor immunogenicity', 'auxological parameters and IGF-1 and IGFBP-3 SDS']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0212600', 'cui_str': 'CERE'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0699616', 'cui_str': 'Genotonorm'}, {'cui': 'C0376560', 'cui_str': 'Recombinant Growth Hormone'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}]",,0.0362274,"Before the switch, both Criscy™ and Genotropin groups were similar concerning demographics, and auxological measures: age, sex, height, height SDS, weight, and BMI.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Czepielewski', 'Affiliation': 'Serviço de Endocrinologia, Hospital de Clínicas de Porto Alegre, UFRGS, Porto Alegre, RS, Brazil. Electronic address: maurocze@terra.com.br.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Garret', 'Affiliation': 'CEDOES, Vitória, ES, Brazil.'}, {'ForeName': 'S A C', 'Initials': 'SAC', 'LastName': 'Vencio', 'Affiliation': 'ICF - Instituto de Ciências Farmacêuticas de Estudos e Pesquisas Ltda, Aparecida de Goiânia, GO, Brazil.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rassi', 'Affiliation': 'Hospital Alberto Rassi - HGG, Goiânia, GO, Brazil.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Faria', 'Affiliation': 'Hospital Universitário da Universidade Federal do Maranhão/HU/UFMA, São Luis, MA, Brazil.'}, {'ForeName': 'C C P', 'Initials': 'CCP', 'LastName': 'Senn', 'Affiliation': 'Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Bronstein', 'Affiliation': 'CPQUALI Pesquisa Clínica Ltda, São Paulo, SP, Brazil.'}, {'ForeName': 'M J A G', 'Initials': 'MJAG', 'LastName': 'Cerqueira', 'Affiliation': 'Instituto de Ensino e Pesquisa Clínica do Ceará, Fortaleza, CE, Brazil.'}, {'ForeName': 'A C L', 'Initials': 'ACL', 'LastName': 'Neves', 'Affiliation': 'Instituto de Medicina Integral Professor Fernando Figueira - IMIP, Recife, PE, Brazil.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Spinola-Castro', 'Affiliation': 'Universidade Federal de São Paulo - UNIFESP/EPM, São Paulo, SP, Brazil.'}, {'ForeName': 'M P R', 'Initials': 'MPR', 'LastName': 'Cunha', 'Affiliation': 'CAEP - Centro Avançado de Estudos e Pesquisas Ltda, Campinas, SP, Brazil.'}, {'ForeName': 'N R', 'Initials': 'NR', 'LastName': 'Leite', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Wassermann', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Alegria', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Toffoletto', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Afiune', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Baradelli', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'D G', 'Initials': 'DG', 'LastName': 'Rodrigues', 'Affiliation': 'Cristália Produtos Químicos Farmacêuticos Ltda, Itapira, SP, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scharf', 'Affiliation': 'Centro de Diabetes de Curitiba, Curitiba, PR, Brazil.'}]",Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society,['10.1016/j.ghir.2020.101372']
2241,33259999,Efficacy and safety of transvaginal high-intensity focused ultrasound therapy in women with symptomatic uterine leiomyomas: A clinical trial.,"OBJECTIVE
To evaluate the efficacy and safety of transvaginal high-intensity focused ultrasound (vHIFU) therapy in women with symptomatic uterine leiomyomas.
METHODS
This first-in-human, two-center, prospective, unblinded, single-arm trial was performed in the Republic of Korea from December 2017 to February 2019. Premenopausal women with symptomatic, contrast-enhanced uterine leiomyomas with a diameter ≤5 cm were eligible. Under sedation or monitored anesthesia, leiomyomas were ablated with vHIFU under ultrasound guidance. The primary endpoint was the non-perfused volume (NPV) ratio measured immediately after therapy. Secondary endpoints were changes in Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scores, dysmenorrhea visual analog scale (VAS), uterine leiomyoma volume, rate of subsequent therapy, and treatment-emergent adverse events (TEAE).
RESULTS
Thirty-five women were screened; 13 women were enrolled and underwent vHIFU therapy for 33 uterine leiomyomas. NPV ratios were 0.76 ± 0.27 (mean ± SD); the lower limit of a one-sided 97.5 % confidence interval was 0.67, surpassing the non-inferiority cut-off of 0.50. UFS-QOL scores (symptom severity score, median, baseline: 66.60, 3-month follow-up: 32.85; p = 0.0010; health related quality of life score, median, baseline: 41.40, 3-month follow-up: 73.30; p = 0.0010) and dysmenorrhea VAS (mean, baseline: 50.92, 3-month follow-up: 20.67; p = 0.0019) improved significantly. Volume of uterine leiomyoma was reduced (median, baseline: 8.10 cm 3 , 3-month follow=-up: 5.30 cm 3 ; p < 0.0001), and none received subsequent therapy. Twenty-six TEAEs from 8 participants were observed, and all TEAEs were resolved without sequelae.
CONCLUSION
vHIFU therapy exhibited promising efficacy and safety and might be considered as a treatment option for women with symptomatic uterine leiomyomas. Registration: This trial was registered at: www.clinicaltrial.gov (NCT03328260).",2020,"Volume of uterine leiomyoma was reduced (median, baseline: 8.10 cm 3 , 3-month follow=-up:","['Registration', 'Premenopausal women with symptomatic, contrast-enhanced uterine leiomyomas with a diameter ≤5 cm were eligible', 'Republic of Korea from December 2017 to February 2019', 'women with symptomatic uterine leiomyomas', 'Thirty-five women were screened; 13 women were enrolled and underwent']","['vHIFU therapy', 'transvaginal high-intensity focused ultrasound (vHIFU) therapy', 'transvaginal high-intensity focused ultrasound therapy']","['changes in Uterine Fibroid Symptom-Quality of Life (UFS-QOL) scores, dysmenorrhea visual analog scale (VAS), uterine leiomyoma volume, rate of subsequent therapy, and treatment-emergent adverse events (TEAE', 'Volume of uterine leiomyoma', 'non-perfused volume (NPV) ratio', 'Efficacy and safety', 'UFS-QOL scores (symptom severity score', 'health related quality of life score', 'NPV ratios', 'efficacy and safety', 'dysmenorrhea VAS']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C2348970', 'cui_str': 'High intensity focused ultrasound ablation'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",13.0,0.27368,"Volume of uterine leiomyoma was reduced (median, baseline: 8.10 cm 3 , 3-month follow=-up:","[{'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kidong', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Electronic address: kidong.kim.md@gmail.com.'}, {'ForeName': 'Sung Il', 'Initials': 'SI', 'LastName': 'Hwang', 'Affiliation': 'Department of Radiology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Keonho', 'Initials': 'K', 'LastName': 'Son', 'Affiliation': 'Therapeutic Ultrasound Division, ALPINION Medical Systems, Seoul, Republic of Korea.'}, {'ForeName': 'Daeseung', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Therapeutic Ultrasound Division, ALPINION Medical Systems, Seoul, Republic of Korea.'}, {'ForeName': 'Sun', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Therapeutic Ultrasound Division, ALPINION Medical Systems, Seoul, Republic of Korea.'}, {'ForeName': 'Yong Beom', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.11.049']
2242,33259976,A Randomized Controlled Trial to Assess the Effect of Lidocaine Administered via Throat Spray and Nebulization in Patients with Refractory Chronic Cough.,"BACKGROUND
Refractory chronic cough (RCC) is a debilitating condition for which there are no licensed treatments. Lidocaine is a non-selective inhibitor of voltage gated sodium channels (VGSC) with potential anti-tussive effects, but randomized placebo-controlled studies evaluating its efficacy in RCC are lacking.
OBJECTIVE
To investigate the efficacy of nebulized lidocaine and lidocaine throat spray versus matched placebos in RCC.
METHODS
A randomized, double-blind, double-dummy, placebo-controlled, three-way crossover study, comparing the effect of single doses of nebulized lidocaine with lidocaine delivered by a throat spray and matched placebo. The primary endpoint was cough frequency over the 10 hours following treatment. Secondary endpoints were visual analogue scores (VAS) for urge-to-cough and cough severity; an exploratory analysis evaluated hourly cough rates up to 5 hours after treatment.
RESULTS
Twenty-six subjects with RCC were recruited [22 females, mean (S.D) age 53.5±12.1 years, FEV1 %predicted 105.2±16.8 L, FVC %predicted 112.4±18L]. Lidocaine throat spray, but not nebulized lidocaine, significantly reduced 10-hour cough frequency as compared to placebo (throat spray 22.6 coughs/hour, nebulization 26.9 coughs/hour, and placebos 27.6 coughs/hour, p=0.04,). Lidocaine throat spray showed the greatest effect on cough compared to placebo in the first hour after administration (31.7 coughs/hour vs 74.2 coughs/hour, p=0.004). Both nebulizer and spray treatments significantly alleviated urge-to-cough and cough severity VAS compared with placebo (p <0.05). There were no serious adverse events associated with lidocaine therapy.
CONCLUSION
Lidocaine throat spray was effective in reducing cough frequency in RCC patients. VGSC inhibitors applied to pharynx have potential as therapies for RCC.",2020,Both nebulizer and spray treatments significantly alleviated urge-to-cough and cough severity VAS compared with placebo (p <0.05).,"['Patients with Refractory Chronic Cough', 'Twenty-six subjects with RCC were recruited [22 females, mean', 'RCC patients']","['placebo', 'lidocaine throat spray', 'Lidocaine throat spray', 'lidocaine', 'nebulized lidocaine', 'VGSC inhibitors', 'RCC', 'Lidocaine', 'Lidocaine Administered via Throat Spray and Nebulization', 'nebulized lidocaine with lidocaine']","['10-hour cough frequency', 'visual analogue scores (VAS) for urge-to-cough and cough severity; an exploratory analysis evaluated hourly cough rates', 'alleviated urge-to-cough and cough severity VAS', 'cough', 'cough frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C3494198', 'cui_str': 'Channel Blockers, Voltage-Gated Sodium'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",26.0,0.48128,Both nebulizer and spray treatments significantly alleviated urge-to-cough and cough severity VAS compared with placebo (p <0.05).,"[{'ForeName': 'Rayid', 'Initials': 'R', 'LastName': 'Abdulqawi', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; Dr. Sulaiman Al Habib Medical Group, Riyadh, Saudi Arabia and Department of Medicine, Alfaisal University, Riyadh, Saudi Arabia; Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Satia', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; McMaster University, Department of Medicine, Division of Respirology.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK; Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Saifudin', 'Initials': 'S', 'LastName': 'Khalid', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; East Lancashire Hospitals NHS Trust, Royal Blackburn Teaching Hospital, Blackburn, UK.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Holt', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Dockry', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Woodcock', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'University of Manchester, Division of Infection, Immunity and Respiratory Medicine, and Manchester Academic Health Science Centre, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK. Electronic address: jacky.smith@manchester.ac.uk.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.11.037']
2243,33259935,Quality of life: A Prospective Randomized Trial of Palliative Volumetric Arc Therapy Versus 3D-Conventional Radiation Therapy.,"PURPOSE
Volumetric Arc Therapy (VMAT) is a radiation (RT) technique that spares normal tissues from high/intermediate RT doses but increases the volume of tissues receiving low doses of RT as compared to 3D-Conformal Radiation Therapy (3DCRT). We hypothesized that palliative VMAT would reduce the detriment to patient quality of life (QOL) compared to palliative 3DCRT.
PATIENTS AND METHODS
This phase 2 trial randomized patients to palliative RT using VMAT or 3DCRT to 1 painful site of metastatic disease in the trunk. Treating physicians could choose 8Gy in 1 fraction or 20Gy in 5 fractions, which are used to stratify randomization. The primary endpoint was the change in EORTC QLQ C30 global health status QOL subscale at 1 week post-RT. Repeated measures ANOVA was used to assess the relationship of patient QOL over time with other factors.
RESULTS
From July 2014-November 2017, 37 3DCRT and 32 VMAT patients were randomized into the study. Median overall survival was 9 months. Overall pain response to RT were equivalent (p=0.53) between the techniques. Patient compliance in returning QOL questionnaires was 94%, 81% and 69% at baseline, 1 week post-RT and 1 month post-RT. At 1 week post-RT, change in global QOL was not significantly (p=0.31) different between VMAT vs. 3DCRT. At 4 weeks post-RT, VMAT induced significantly (p=0.049) less global QOL deterioration than 3DCRT. VMAT patients maintained better physical (p=0.012), role (p=0.041) and social (p=0.025) functionings, but reported more diarrhea symptoms (p=0.017) than 3DCRT patients.
CONCLUSIONS
Palliative VMAT and 3DCRT did not differ in their ability to control pain. However, palliative VMAT induced less QOL detriments than 3DCRT at 4 weeks post-RT.",2020,"VMAT patients maintained better physical (p=0.012), role (p=0.041) and social (p=0.025) functionings, but reported more diarrhea symptoms (p=0.017) than 3DCRT patients.
","['From July 2014-November 2017, 37 3DCRT and 32 VMAT patients']","['Palliative Volumetric Arc Therapy Versus 3D-Conventional Radiation Therapy', 'Palliative VMAT and 3DCRT', 'VMAT or 3DCRT', 'palliative VMAT', '3DCRT', 'VMAT', 'Volumetric Arc Therapy (VMAT', 'VMAT vs. 3DCRT']","['change in EORTC QLQ C30 global health status QOL subscale', 'Patient compliance in returning QOL questionnaires', 'Overall pain response', 'diarrhea symptoms', 'QOL detriments', 'patient quality of life (QOL', 'Quality of life', 'global QOL', 'global QOL deterioration', 'Median overall survival']","[{'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0506688,"VMAT patients maintained better physical (p=0.012), role (p=0.041) and social (p=0.025) functionings, but reported more diarrhea symptoms (p=0.017) than 3DCRT patients.
","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), QC, Canada; Department of Radiation Oncology, Princess Margaret Cancer Centre, ON, Canada. Electronic address: philip.wong@rmp.uhn.ca.""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Lambert', 'Affiliation': 'Department of Radiation Oncology, Centre Intégré de Cancérologie de Laval (CICL), QC, Canada.'}, {'ForeName': 'Phengsavanh', 'Initials': 'P', 'LastName': 'Thanomsack', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), QC, Canada.""}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Coulombe', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), QC, Canada; Department of Radiation Oncology, Centre de radio-oncologie à l'Hôpital de Chicoutimi, CIUSSS du SLSJ, QC, Canada.""}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), QC, Canada.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Charpentier', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), QC, Canada.""}, {'ForeName': 'Maroie', 'Initials': 'M', 'LastName': 'Barkati', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), QC, Canada.""}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Fortin', 'Affiliation': 'Department of Radiation Oncology, Hopital Maisonneuve-Rosemont, QC, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lafontaine', 'Affiliation': ""Centre de recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), QC, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Roberge', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal (CHUM), QC, Canada.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.11.061']
2244,33259933,"Radical Hemithoracic Radiotherapy vs. Palliative Radiotherapy in Non-metastatic Malignant Pleural Mesothelioma: Results from a Phase III, Randomized Clinical Trial.","PURPOSE
We conducted a phase III randomized clinical trial to assess whether Radical Hemithoracic Radiotherapy (RHR) compared to palliative radiotherapy (PR), may achieve overall survival (OS) advantages in malignant pleural mesothelioma (MPM) patients.
METHODS
from August 2014 to May 2018, patients with hystologically diagnosed non-metastatic MPM, who underwent non-radical lung-sparing surgery and chemotherapy (CHT) were randomly assigned (1:1) to receive RHR or PR. RHR total dose to the involved pleural cavity was 50Gy in 25 fractions and the gross residual disease received a simultaneous integrated boost of 60Gy. The primary end-point was OS. Secondary end points were: local control, distant metastasis free survival, progression free survival, acute and late toxicity rates. A total sample size of 108 patients considering a type I error (α) of 0.05 and a statistical power of 80% was calculated to prove that RHR could improve the 2-year OS. OS was estimated with the Kaplan-Meier method and the log-rank test (two-sided) tested differences between arms. The univariate and multivariate analyses were performed by using Cox proportional hazard model. Possible prognostic factors investigated: age, sex, performance status, lung surgery, gross residual disease and histology.
RESULTS
108 patients were randomized: 53 to PR arm and 55 to RHR arm. Median follow-up was 14.6 months. The 2-year OS rate was 58% in RHR arm vs. 28% in PR arm (HR 0.54, 95% CI 0.31-0.95, p=0.031). In RHR arm: 11 patients experienced Grade≥ 3 acute toxicity, 17 had Grade 3-4 late toxicity. Nine patients experience a Grade ≥2 pneumonitis, including 1 Grade 5.
CONCLUSIONS
RHR significantly improves survival in MPM patients treated with non-radical lung sparing surgery and CHT compared to palliative treatments, although associated to a not negligible toxicity profile.",2020,"The 2-year OS rate was 58% in RHR arm vs. 28% in PR arm (HR 0.54, 95% CI 0.31-0.95, p=0.031).","['108 patients were randomized: 53 to PR arm and 55 to RHR arm', '108 patients considering a type I error (α) of 0.05 and a statistical power of 80', 'Non-metastatic Malignant Pleural Mesothelioma', 'Nine patients experience a Grade ≥2 pneumonitis, including 1 Grade 5', 'malignant pleural mesothelioma (MPM) patients', 'from August 2014 to May 2018, patients with hystologically diagnosed non-metastatic MPM, who underwent non-radical lung-sparing surgery and chemotherapy (CHT']","['RHR or PR', 'Radical Hemithoracic Radiotherapy vs. Palliative Radiotherapy', 'palliative radiotherapy (PR', 'Radical Hemithoracic Radiotherapy (RHR']","['overall survival (OS) advantages', 'survival', 'Grade≥ 3 acute toxicity', '2-year OS rate', 'local control, distant metastasis free survival, progression free survival, acute and late toxicity rates', '2-year OS']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0812413', 'cui_str': 'Malignant mesothelioma of pleura'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0302912', 'cui_str': 'Radical'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",108.0,0.096501,"The 2-year OS rate was 58% in RHR arm vs. 28% in PR arm (HR 0.54, 95% CI 0.31-0.95, p=0.031).","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Trovo', 'Affiliation': 'National Cancer Institute of Aviano, Italy; Udine Academic Hospital, Italy. Electronic address: marcotrovo33@hotmail.com.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Revelant', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Jerry Polesel', 'Initials': 'JP', 'LastName': 'Scd', 'Affiliation': 'National Cancer Institute of Aviano, Italy. Electronic address: polesel@cro.it.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Muraro', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Barresi', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Drigo', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Tanjia', 'Initials': 'T', 'LastName': 'Baresic', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Bearz', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Fanetti', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Del Conte', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Matrone', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Reverberi', 'Affiliation': 'Udine Academic Hospital, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Furlan', 'Affiliation': 'Belluno General Hospital, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Zuccon', 'Affiliation': 'Pordenone General Hospital, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fontana', 'Affiliation': 'Mestre General Hospital, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Franchin', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Minatel', 'Affiliation': 'National Cancer Institute of Aviano, Italy.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.11.057']
2245,33259910,"The effect of Kneipp treatment hydrotherapy on secretory IgA in young children: a controlled, non-randomized clinical pilot study.","OBJECTIVES
This pilot study analyses the effect and feasibility of hydrotherapeutic Kneipp arm affusions on secretory immunoglobulin A (sIgA) and classic cold symptoms in children 3-6 years of age.
STUDY DESIGN
A controlled, non-randomized, clinical pilot study was undertaken.
INTERVENTION
This descriptive hydrotherapeutic intervention treated children aged 3-6 with Kneipp arm affusions over four weeks. The control group received no intervention. At baseline and after the intervention, secretory IgA was measured, cold symptoms were assessed by means of the Common Cold Questionnaire (CCQ), and a semi-structured follow-up qualitative interview of the parents in the intervention group was conducted on acceptance and susceptibility to infection of the respiratory tract.
RESULTS
Fifteen participants were included in the intervention group and 15 were in the control group. The Kneipp arm affusions intervention was conducted at home and well-accepted by the children. No differences developed between the groups regarding sIgA. Comparing the symptoms by means of CCQ did not show symptoms of respiratory tract infections. In the intervention group, rhinitis occurred less frequently (26.7% vs. 66.7%, p = 0.057). In the qualitative analysis, 9/13 parents described an improvement in susceptibility to infections of the respiratory tract.
CONCLUSION
Due to the pilot character of this study, home hydrotherapy (Kneipp arm affusions) in healthy children is feasible but did not influence sIgA levels. The influence on infections of the respiratory tract after the intervention phase should be interpreted carefully. In qualitative interviews, parents described less susceptibility to infections of the respiratory tract by their children.",2020,"In the intervention group, rhinitis occurred less frequently (26.7% vs. 66.7%, p = 0.057).","['children 3-6 years of age', 'healthy children', 'Fifteen participants were included in the intervention group and 15 were in the control group', 'young children', 'treated children aged 3-6 with Kneipp arm affusions over four weeks']","['Kneipp treatment hydrotherapy', 'hydrotherapeutic intervention', 'no intervention', 'hydrotherapeutic Kneipp']","['secretory immunoglobulin A (sIgA) and classic cold symptoms', 'susceptibility to infections of the respiratory tract', 'rhinitis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442759', 'cui_str': '3/6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0863093', 'cui_str': 'Cold symptoms'}, {'cui': 'C0521978', 'cui_str': 'Susceptibility to infections'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}]",15.0,0.0432896,"In the intervention group, rhinitis occurred less frequently (26.7% vs. 66.7%, p = 0.057).","[{'ForeName': 'Klaudia', 'Initials': 'K', 'LastName': 'Schulte', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: klaudia.schulte@charite.de.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Blakeslee', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Stritter', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Eidenschink', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Gündling', 'Affiliation': 'Dean of studies naturopathy and complementary medicine, Carl Remigius Medical School, Idstein, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baumann', 'Affiliation': 'Competence Centre for University Didactics in Medicine, Tübingen, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': 'Department of Pediatric Oncology/Hematology, Otto-Heubner Centre for Pediatric and Adolescent Medicine (OHC), Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Augustenburger Platz 1, 13353 Berlin, Germany; University of São Paulo, Faculty of Medicine, Department of Pediatrics São Paulo, Estado de Sao Paulo, Brazil.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102637']
2246,33259892,Third-line treatment of HER2-positive advanced breast cancer: From no standard to a Pandora's box.,"Human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer (ABC) accounts for about 15-20% of all ABC cases. Large randomized trials have determined the standard first- and second-line treatments for this subgroup of patients, namely dual blockade plus chemotherapy and TDM1. However, no standard treatment is specifically recommended after TDM1, and most of the subsequent therapeutic choices commonly rely on old trials not optimally reflecting the current patient population. The recent FDA-approval of three novel anti-HER2 compounds is revolutionizing the field. In particular, trastuzumab deruxtecan was approved after showing unprecedented activity in a phase 2 trial for highly pretreated HER2+ ABC patients; tucatinib and neratinib were approved based on the results of the randomized HER2CLIMB and NALA trial, respectively. With an increasing arsenal of treatment options, clinical decision-making will need to take into account a variety of aspects, including differences in clinical trial designs, outcomes and toxicity profile of each drug, patient's characteristics and preferences.",2020,"With an increasing arsenal of treatment options, clinical decision-making will need to take into account a variety of aspects, including differences in clinical trial designs, outcomes and toxicity profile of each drug, patient's characteristics and preferences.","['Human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer', 'HER2-positive advanced breast cancer']",['blockade plus chemotherapy and TDM1'],[],"[{'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0380268,"With an increasing arsenal of treatment options, clinical decision-making will need to take into account a variety of aspects, including differences in clinical trial designs, outcomes and toxicity profile of each drug, patient's characteristics and preferences.","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tarantino', 'Affiliation': 'European Institute of Oncology IRCCS, Milan, Italy; University of Milan, Milan, Italy.'}, {'ForeName': 'Aleix', 'Initials': 'A', 'LastName': 'Prat', 'Affiliation': 'Translational Genomics and Targeted Therapies, IDIBAPS, Barcelona, Spain; University of Barcelona, Barcelona, Spain; Department of Medical Oncology, Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': ""IOB Institute of Oncology, Quiron group, Madrid, Barcelona, Spain; Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.""}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Curigliano', 'Affiliation': 'European Institute of Oncology IRCCS, Milan, Italy; University of Milan, Milan, Italy. Electronic address: Giuseppe.curigliano@ieo.it.'}]",Biochimica et biophysica acta. Reviews on cancer,['10.1016/j.bbcan.2020.188487']
2247,33259829,"Beneficial effects of a high protein breakfast on fullness disappear after a night of short sleep in nonobese, premenopausal women.","As insufficient sleep and obesity become more widespread, finding strategies to overcome changes in appetite and food cravings after sleep reduction is imperative. This study examined the effects of a high-protein (HP) and high-carbohydrate (HC) breakfast on appetitive sensations, food cravings, and dietary intake after nights of habitual (HS) and curtailed sleep (CS). Twenty-seven non-obese, premenopausal women who reported routinely eating breakfast participated in this randomized crossover study. Participants completed 4 laboratory visits with different combinations of sleep and breakfast conditions. Sleep was reduced by 33% on curtailed nights. At each visit, appetitive sensations were measured before breakfast and every 30 min thereafter throughout the 4-hour visit; area under the curve (AUC) was calculated. Food cravings were assessed before and 3.5 h after breakfast. Intake of ad libitum lunch and daily dietary intake were measured. Regardless of the breakfast condition, CS increased hunger (p = 0.043) and desire to eat (p = 0.044) and decreased fullness (p = 0.035). The HP breakfast increased fullness AUC after HS (p = 0.022) but not CS. Regardless of the sleep condition, the changes in food cravings scores were significantly different based on breakfast condition (p = 0.009), with food cravings increased after the HC breakfast and decreased after the HP breakfast. However, breakfast condition did not influence hunger or desire to eat AUC after either sleep condition. Neither the breakfast condition nor the sleep condition influenced lunch and daily energy intake. In conclusion, it appears protein reduces food cravings regardless of sleep condition in this population but obtaining sufficient sleep is necessary to benefit from the effects of high protein intake on fullness.",2020,"Regardless of the breakfast condition, CS increased hunger (p=0.043) and desire to eat (p=0.044) and decreased fullness (p=0.035).","['nonobese, premenopausal women', 'Participants completed 4 laboratory visits with different combinations of sleep and breakfast conditions', 'Twenty-seven non-obese, premenopausal women who reported routinely eating breakfast participated']","['high-protein (HP) and high-carbohydrate (HC) breakfast', 'high protein breakfast']","['food cravings', 'food cravings scores', 'Food cravings', 'hunger', 'Sleep', 'fullness', 'sleep condition influenced lunch and daily energy intake', 'fullness disappear', 'hunger or desire to eat AUC', 'daily dietary intake', 'fullness AUC', 'desire to eat', 'appetitive sensations, food cravings, and dietary intake after nights of habitual (HS) and curtailed sleep (CS']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}]","[{'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]",,0.0210598,"Regardless of the breakfast condition, CS increased hunger (p=0.043) and desire to eat (p=0.044) and decreased fullness (p=0.035).","[{'ForeName': 'Chia-Lun', 'Initials': 'CL', 'LastName': 'Yang', 'Affiliation': 'Department of Food Science and Human Nutrition, Michigan State University, 2110 Anthony Hall, 474 S. Shaw Lane, East Lansing, MI 48824, USA. Electronic address: yangch39@msu.edu.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Tucker', 'Affiliation': 'Department of Food Science and Human Nutrition, Michigan State University, 2110 Anthony Hall, 474 S. Shaw Lane, East Lansing, MI 48824, USA. Electronic address: tucker98@msu.edu.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113269']
2248,33259790,"Prolonged, Controlled Daytime versus Delayed Eating Impacts Weight and Metabolism.","A delayed eating schedule is associated with increased risk of obesity and metabolic dysfunction in humans. 1-9 However, there are no prolonged, highly controlled experimental studies testing the effects of meal timing on weight and metabolism in adults with a body mass index (BMI) of 19-27 kg/m 2 . 10-18 Twelve healthy adults (age: 26.3 ± 3.4 years; BMI: 21.9 ± 1.7 kg/m 2 ; 5 females) participated in a randomized crossover study in free-living conditions. Three meals and two snacks with comparable energy and macronutrient contents were provided during two, 8-week, counterbalanced conditions separated by a 2-week washout period: (1) daytime (intake limited to 0800 h-1900 h) and (2) delayed (intake limited to 1200 h-2300 h). Sleep-wake cycles and exercise levels were held constant. Weight, adiposity, energy expenditure, and circadian profiles of hormones and metabolites were assessed during four inpatient visits occurring before and after each condition. Body weight, insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR]), trunk-to-leg fat ratio, resting energy expenditure, respiratory quotient, and fasting glucose, insulin, total and high-density lipoprotein (dHDL) cholesterol, and adiponectin decreased on the daytime compared to the delayed schedule. These measures, as well as triglycerides, increased on the delayed compared to the daytime schedule (effect size range: d = 0.397-1.019). Circadian phase and amplitude of melatonin, cortisol, ghrelin, leptin, and glucose were not differentially altered by the eating schedules. Overall, an 8-week daytime eating schedule, compared to a delayed eating schedule, promotes weight loss and improvements in energy metabolism and insulin in adults with BMI 19-27 kg/m 2 , underscoring the efficacy and feasibility of daytime eating as a behavioral modification for real-world conditions.",2020,"Circadian phase and amplitude of melatonin, cortisol, ghrelin, leptin, and glucose were not differentially altered by the eating schedules.","['adults with a body mass index (BMI) of 19-27\xa0kg', '10-18 Twelve healthy adults (age: 26.3\xa0± 3.4 years; BMI: 21.9\xa0± 1.7\xa0kg/m 2 ; 5 females', 'humans']",[],"['Circadian phase and amplitude of melatonin, cortisol, ghrelin, leptin, and glucose', 'weight loss and improvements in energy metabolism and insulin', 'risk of obesity and metabolic dysfunction', 'Sleep-wake cycles and exercise levels', 'Weight, adiposity, energy expenditure, and circadian profiles of hormones and metabolites', 'weight and metabolism', 'Body weight, insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR]), trunk-to-leg fat ratio, resting energy expenditure, respiratory quotient, and fasting glucose, insulin, total and high-density lipoprotein (dHDL) cholesterol, and adiponectin']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]",[],"[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",12.0,0.0167302,"Circadian phase and amplitude of melatonin, cortisol, ghrelin, leptin, and glucose were not differentially altered by the eating schedules.","[{'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Allison', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA. Electronic address: kca@pennmedicine.upenn.edu.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Hopkins', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Madelyn', 'Initials': 'M', 'LastName': 'Ruggieri', 'Affiliation': 'Center for Weight and Eating Disorders, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Spaeth', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University, New Brunswick, NJ 08901, USA.'}, {'ForeName': 'Rexford S', 'Initials': 'RS', 'LastName': 'Ahima', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Johns Hopkins University, Baltimore, MD 21287, USA.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Biomedical Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA.""}, {'ForeName': 'Deanne M', 'Initials': 'DM', 'LastName': 'Taylor', 'Affiliation': ""Department of Biomedical Informatics, The Children's Hospital of Philadelphia, Philadelphia, PA 19104, USA; Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA.""}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA; Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL 60612, USA.'}]",Current biology : CB,['10.1016/j.cub.2020.10.092']
2249,33259771,Synthetic Versus Biologic Mesh for Complex Open Ventral Hernia Repair: A Pilot Randomized Controlled Trial.,"Background: Many surgeons utilize biologic mesh for elective complex ventral hernia repair (VHR; large hernias, contaminated fields, or patients with comorbid conditions). However, no randomized controlled trials (RCTs) have compared biologic and synthetic mesh. We hypothesize biologic mesh would result in fewer major complications at one-year post-operative compared with synthetic mesh. Patients and Methods: We performed a single-center, pilot RCT. All eligible patients undergoing complex, open VHR were randomly assigned to receive biologic or synthetic mesh placed in the retromuscular position. Primary outcome was major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative. Secondary outcomes included surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade. Outcomes were assessed using Fisher exact test and Bayesian generalized linear models. Results: Of 87 patients, 44 were randomly assigned to biologic mesh and 43 to synthetic mesh. Most cases were wound class 2-4 (68%) and 75% had a hernia width >4 cm. Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53%). Compared with patients in the synthetic mesh group, patients in the biologic mesh group had a higher percentage of: major complications at one-year post-operative (42.4% vs. 21.6%; relative risk [RR] = 1.96 [95% confidence interval {CI} = 0.94-4.08]; number needed to harm = 4.8; p = 0.071); SSI (15.9% vs. 9.3%; RR = 1.71 [95% CI = 0.54-5.42]; p = 0.362); wound dehiscence (25.0% vs. 14.0%; RR = 1.79 [95% CI = 0.73-4.41]; p = 0.205); and re-admissions (22.7% vs 9.3%; RR = 2.44 [95% CI = 0.83-7.20]; p = 0.105). Bayesian analysis demonstrated that compared with synthetic mesh, biologic mesh had a 95% probability of increased risk of major complications at one-year post-operative. No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. Conclusions: In elective complex open VHR, biologic mesh demonstrated no benefit compared with synthetic mesh in one-year outcomes. Moreover, Bayesian analysis suggests that biologic mesh may have an increased probability of major complications.",2020,"No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. ","['87 patients, 44 were randomly assigned to', 'Most patients were obese (70%) and had an American Society of Anesthesiogists (ASA) score of 3-4 (53', 'All eligible patients undergoing complex, open VHR', 'Complex Open Ventral Hernia Repair', 'patients with comorbid conditions']","['biologic mesh and 43 to synthetic mesh', 'biologic or synthetic mesh placed in the retromuscular position', 'Synthetic Versus Biologic Mesh']","['risk of major complications', 'percentage of: major complications', 'wound dehiscence', 'probability of major complications', 'major complications, namely, a composite of mesh infection, recurrence, or re-operation at one-year post-operative', 'surgical site infections (SSI), seromas, hematomas, wound dehiscence, re-admissions, and Clavien-Dindo complication grade', 'seromas, hematomas, or Clavien-Dindo complication grade']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1869199', 'cui_str': 'DUSP3 protein, human'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0259768', 'cui_str': 'Wound dehiscence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]",,0.357939,"No clear evidence of a difference was found on seromas, hematomas, or Clavien-Dindo complication grade. ","[{'ForeName': 'Oscar A', 'Initials': 'OA', 'LastName': 'Olavarria', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Bernardi', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Naila H', 'Initials': 'NH', 'LastName': 'Dhanani', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Lyons', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Harvin', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Stefanos G', 'Initials': 'SG', 'LastName': 'Millas', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Tien C', 'Initials': 'TC', 'LastName': 'Ko', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Lillian S', 'Initials': 'LS', 'LastName': 'Kao', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Mike K', 'Initials': 'MK', 'LastName': 'Liang', 'Affiliation': 'Department of Surgery, McGovern Medical School at the University of Texas Health Science Center at Houston, Houston, Texas, USA.'}]",Surgical infections,['10.1089/sur.2020.166']
2250,33259734,Effect of Yugengtongyu Granules in Patients with Stable Coronary Artery Disease on Reducing Adverse Cardiovascular Events: A Double-Blind Controlled Trial.,"Objectives: To evaluate the effect of Yugengtongyu granules on reducing the incidence of adverse cardiovascular events and improving quality of life (QOL) in patients with stable coronary artery disease (SCAD). Methods: A double-blind randomized controlled trial was conducted among SCAD population. One hundred fourteen patients were randomly assigned to experimental group ( n = 57) and control group ( n = 57) following randomized block design. Combined with the basis of standard treatment of SCAD, the experimental group and control group received Yugengtongyu granules or placebo, respectively, twice daily for 6 months and were followed for another 1 year (18 months in total from enrollment). Major outcomes (any occurrence of cardiovascular death, nonfatal myocardial infarction, or coronary revascularization), minor outcomes (any occurrence of all-cause death, ischemic stroke, readmission due to unstable angina, heart failure, or malignant arrhythmia), and composite outcomes (union of major and minor outcomes) were used to evaluate prognosis; Seattle Angina Questionnaire (SAQ) was applied to evaluate QOL, and levels of low density lipoprotein-cholesterol (LDL-C) and high sensitive C reacting protein (HS-CRP) in serum were tested. Results: The incidence of composite outcomes in the experimental group was significantly lower than that in the control group (3 [5.2%] vs. 11 [19.2%], hazard ratio: 0.273, 95% confidence interval: 0.080-0.926, p = 0.022); major outcomes, minor outcomes, and independent events such as nonfatal myocardial infarction showed lowering trend in experimental group. Experimental group scored significantly higher than control group in four dimensions of SAQ: physical limitation, angina frequency, treatment satisfaction, and disease perception at the third- and sixth-month follow-up; there was no significant difference in serum level of LDL or HS-CRP at all scheduled timepoints. Conclusion: The addition of Yugengtongyu granules based on current standard treatment reduced the incidence of composite outcomes and improved QOL in patients with SCAD. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-13004370).",2020,"Experimental group scored significantly higher than control group in four dimensions of SAQ: physical limitation, angina frequency, treatment satisfaction, and disease perception at the third- and sixth-month follow-up; there was no significant difference in serum level of LDL or HS-CRP at all scheduled timepoints. ","['patients with SCAD', 'Patients with Stable Coronary Artery Disease on Reducing Adverse Cardiovascular Events', 'patients with stable coronary artery disease (SCAD', 'One hundred fourteen patients']","['Yugengtongyu granules', 'Yugengtongyu Granules', 'Yugengtongyu granules or placebo']","['incidence of composite outcomes', 'Major outcomes (any occurrence of cardiovascular death, nonfatal myocardial infarction, or coronary revascularization), minor outcomes (any occurrence of all-cause death, ischemic stroke, readmission due to unstable angina, heart failure, or malignant arrhythmia), and composite outcomes (union of major and minor outcomes) were used to evaluate prognosis; Seattle Angina Questionnaire (SAQ', 'SAQ: physical limitation, angina frequency, treatment satisfaction, and disease perception', 'incidence of composite outcomes and improved QOL', 'nonfatal myocardial infarction', 'QOL, and levels of low density lipoprotein-cholesterol (LDL-C) and high sensitive C reacting protein (HS-CRP', 'quality of life (QOL', 'serum level of LDL or HS-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342783', 'cui_str': 'Deficiency of butyryl-CoA dehydrogenase'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0050133', 'cui_str': '9,10-anthraquinone'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",114.0,0.219106,"Experimental group scored significantly higher than control group in four dimensions of SAQ: physical limitation, angina frequency, treatment satisfaction, and disease perception at the third- and sixth-month follow-up; there was no significant difference in serum level of LDL or HS-CRP at all scheduled timepoints. ","[{'ForeName': 'Dayang', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Cardiovascular Institute, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Cardiovascular Institute, Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Jiangxi Province Hospital of Integrated Chinese and Western Medicine, Nanchang, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Shandong University of Chinese Medicine Affiliated Hospital, Jinan, China.'}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Jingyin', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, Shunyi Branch of Beijing Hospital of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0361']
2251,33259725,The Tinnitus Retraining Therapy Counseling Protocol as Implemented in the Tinnitus Retraining Therapy Trial.,"Purpose This clinical focus article is a companion to the work of Erdman et al. (2019), in which we described the rationale, development, and implementation of the standard-of-care protocol used in the Tinnitus Retraining Therapy Trial (TRTT), a multicenter, placebo-controlled, randomized, definitive efficacy trial of tinnitus retraining therapy (TRT). We now describe the historical background, development, and standardized implementation and delivery of the TRT counseling protocol (tinnitus counseling [TC]) used in the TRTT. TC is conjectured to be the key component in the TRT protocol for initiating the habituation process that reduces the response to the tinnitus signal and, ultimately, reduces its impact. In the TRTT, participants assigned to receive TC achieved > 30% reduction in the impact of tinnitus. Method and Results The design and implementation of standardized treatments in multisite randomized controlled trials presents many challenges for investigators. Here, subsequent to presenting the background, rationale, and the TRT protocol model, we describe the development, refinement, and training/certification for standardized delivery of TC in the TRTT. The primary challenges encountered while distilling and streamlining TC for standardized delivery across multiple clinicians and their replacements at six participating military treatment centers in the TRTT are considered, and the resulting counseling protocol is detailed. Conclusions The standardized and streamlined TC used in the TRTT was successful for treating debilitating tinnitus among persons with functionally adequate unaided hearing sensitivity. The structured TC protocol described here appears to be the main determinant of the significant and sizable TRT treatment effects measured in the TRTT, thus bolstering the merits of this standardized counseling approach as one model for the clinical implementation of TRT for the treatment of primary tinnitus.",2020,The standardized and streamlined TC used in the TRTT was successful for treating debilitating tinnitus among persons with functionally adequate unaided hearing sensitivity.,['persons with functionally adequate unaided hearing sensitivity'],"['placebo', 'tinnitus retraining therapy (TRT', 'Tinnitus Retraining Therapy Counseling Protocol', 'TC', 'TRT counseling protocol (tinnitus counseling [TC']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0439846', 'cui_str': 'Unaided'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.0477357,The standardized and streamlined TC used in the TRTT was successful for treating debilitating tinnitus among persons with functionally adequate unaided hearing sensitivity.,"[{'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Gold', 'Affiliation': 'Tinnitus & Hyperacusis Center, Department of Otolaryngology, University of Maryland Medical Center, Baltimore.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Formby', 'Affiliation': 'Department of Communicative Disorders, The University of Alabama, Tuscaloosa.'}, {'ForeName': 'Roberta W', 'Initials': 'RW', 'LastName': 'Scherer', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}]",American journal of audiology,['10.1044/2020_AJA-20-00024']
2252,33259721,Pain Control with Lavender Oil in Premature Infants: A Double-Blind Randomized Controlled Study.,"Objectives: Aromatherapy has become popular in pain control in recent years compared with other complementary methods. Lavender ( Lavandula angustifolia Miller) is a fragrant essential oil used in aromatherapy for its antibacterial, antifungal, muscle-relaxing, and analgesic effects. The smell of lavender oil, known for its soothing effect on adults, has not been adequately investigated in regards to pain control in premature infants. The purpose of our study was to assign the effect of the scent of lavender oil on pain in preterm infants during heel lancing. Design: A double-blind randomized controlled clinical study Settings/Location: The study was conducted in a third-level neonatal intensive care unit of Bezmialem Vakif University Hospital from March 2019 to November 2019. It consisted of two groups. Subjects: Sixty-one premature babies (24-37 weeks of gestation) were enrolled in the study. Interventions: Heel stick sampling for metabolic screening was used for both study groups. The interventions were performed by two experienced nurses. Heart rate, oxygen saturation, and the baby's facial expression were recorded by a camera 3 min before the intervention, during the sampling, and 3 min after the procedure. After collecting the data, the head researcher and the assistant researcher separately watched the videos and scored them by using the Premature Infant Pain Profile-Revised (PIPP-R). Outcome measures: The difference of pain scores (PIIP-R) between two groups. Results: There was a statistically significant difference between the two groups in terms of PIPP-R scores during and after the sampling ( p = 0.008 and p = 0.03 respectively). The PIPP-R scores at the beginning of the procedure were not found to be significantly different between the groups ( p > 0.05). Conclusions: Inhalation of lavender scent is effective in pain control in premature infants. It is safe and low cost; it does not interfere with medical care.",2020,There was a statistically significant difference between the two groups in terms of PIPP-R scores during and after the sampling ( p = 0.008 and p = 0.03 respectively).,"['Subjects: Sixty-one premature babies (24-37 weeks of gestation) were enrolled in the study', 'Premature Infants', 'premature infants', 'a third-level neonatal intensive care unit of Bezmialem Vakif University Hospital from March 2019 to November 2019', 'preterm infants during heel lancing']","['lavender scent', 'Aromatherapy', 'Lavender ( Lavandula angustifolia Miller', 'Pain Control with Lavender Oil', 'lavender oil']","[""Heart rate, oxygen saturation, and the baby's facial expression"", 'pain scores (PIIP-R', 'PIPP-R scores']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}]","[{'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0031516', 'cui_str': 'Recognition odor'}, {'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C1623196', 'cui_str': 'Lavandula angustifolia'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0064694', 'cui_str': 'lavender oil'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1120215', 'cui_str': 'PIIP'}, {'cui': 'C0070798', 'cui_str': 'PtdIns(4,5)P2'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0890511,There was a statistically significant difference between the two groups in terms of PIPP-R scores during and after the sampling ( p = 0.008 and p = 0.03 respectively).,"[{'ForeName': 'Ceren', 'Initials': 'C', 'LastName': 'Usta', 'Affiliation': 'Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Tanyeri-Bayraktar', 'Affiliation': 'Department of Neonatology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Bayraktar', 'Affiliation': 'Department of Pediatric Intensive Care, Haseki Training and Research Hospital, Istanbul, Turkey.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0327']
2253,33259720,Effectivity of dexamethasone in patients undergoing off-pump coronary artery bypass surgery.,"BACKGROUND
Based on our previous pilot study, systemic inflammatory response syndrome is more common in off-pump compared to on-pump coronary artery bypass. Therefore, we conducted a clinical trial of dexamethasone in patients undergoing off-pump coronary artery bypass.
METHODS
Sixty consecutive patients undergoing off-pump coronary artery bypass were enrolled from August 2018 to January 2019 and randomized to a dexamethasone or placebo group of 30 each. Clinical outcomes were analyzed.
RESULTS
There was a lower incidence of major adverse cardiac events in the dexamethasone group compared to the placebo group (17% versus 43%, p = 0.024). Clinical outcomes in the dexamethasone group were better than those in the placebo group, in terms of duration of mechanical ventilation ( p = 0.029), intensive care unit stay ( p = 0.028), hospital stay ( p = 0.04), and vasoactive-inotropic score ( p = 0.045). There were significant differences in inflammatory markers between the two groups: interleukin-6 ( p = 0.0001), procalcitonin ( p = 0.0001), and C-reactive protein ( p = 0.0001) were lower in the dexamethasone group. There was a significant association between the incidence of major adverse cardiac events and both interleukin-6 ( p = 0.005) and procalcitonin ( p = 0.007).
CONCLUSION
Preoperative dexamethasone in patients undergoing off-pump coronary artery bypass is effective in improving clinical outcomes and controlling the postoperative inflammatory reaction.",2020,"There were significant differences in inflammatory markers between the two groups: interleukin-6 ( p = 0.0001), procalcitonin ( p = 0.0001), and C-reactive protein ( p = 0.0001) were lower in the dexamethasone group.","['patients undergoing off-pump coronary artery bypass surgery', 'patients undergoing off-pump coronary artery bypass', 'Sixty consecutive patients undergoing off-pump coronary artery bypass were enrolled from August 2018 to January 2019 and randomized to a', 'group of 30 each']","['Preoperative dexamethasone', 'dexamethasone or placebo', 'placebo', 'dexamethasone']","['Effectivity', 'incidence of major adverse cardiac events', 'hospital stay', 'incidence of major adverse cardiac events and both interleukin-6', 'duration of mechanical ventilation', 'intensive care unit stay', 'vasoactive-inotropic score', 'inflammatory markers', 'C-reactive protein']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1449706', 'cui_str': 'Off-pump coronary artery bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",60.0,0.367661,"There were significant differences in inflammatory markers between the two groups: interleukin-6 ( p = 0.0001), procalcitonin ( p = 0.0001), and C-reactive protein ( p = 0.0001) were lower in the dexamethasone group.","[{'ForeName': 'Dudy Arman', 'Initials': 'DA', 'LastName': 'Hanafy', 'Affiliation': 'National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'I Komang Adhi Parama', 'Initials': 'IKAP', 'LastName': 'Harta', 'Affiliation': 'National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'I Made Indra', 'Initials': 'IMI', 'LastName': 'Prasetya', 'Affiliation': 'RSUP Sanglah Hospital, Denpasar, Bali, Indonesia.'}, {'ForeName': 'Pribadi Wiranda', 'Initials': 'PW', 'LastName': 'Busroh', 'Affiliation': 'National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Tri Wisesa', 'Initials': 'TW', 'LastName': 'Soetisna', 'Affiliation': 'National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Dicky Aligheri', 'Initials': 'DA', 'LastName': 'Wartono', 'Affiliation': 'National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Tjubandi', 'Affiliation': 'National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}, {'ForeName': 'Bagus', 'Initials': 'B', 'LastName': 'Herlambang', 'Affiliation': 'National Cardiovascular Center Harapan Kita, Jakarta, Indonesia.'}]",Asian cardiovascular & thoracic annals,['10.1177/0218492320977648']
2254,33259688,Lactobacillus brevis CD2 attenuates traumatic oral lesions induced by fixed orthodontic appliance: A randomized phase 2 trial.,"OBJECTIVE
To evaluate the effect of the probiotic Lactobacillus brevis CD2 on the prevention of early traumatic oral lesions induced by a fixed orthodontic appliance.
SETTINGS AND SAMPLE POPULATION
Twenty orthodontic patients (14-57 yo) were recruited from a private clinic.
SUBJECTS AND METHODS
In a phase 2, double-blind clinical trial, all patients were randomly allocated (1:1 ratio) to a 21-day course of soluble tablets containing L brevis CD2 (4 billion colony-forming units after breakfast, lunch, and dinner) or placebo, starting at the day of orthodontic appliance placement. The primary outcomes were days with oral lesions and lesions-related pain [ranging between 0 (no pain) and 10 (maximum pain)]. Oral health-related quality of life was measured using OHIP-14 before and after treatments.
RESULTS
All patients completed the study. Ten were treated with L brevis (28.1 ± 13.3 yo, 70% women) and 10 received placebo (27.5 ± 9.1 yo, 60% women). The oral lesions lasted significantly less time (P = 0.018) in patients treated with L brevis (2.5 ± 1.0 days) than with placebo (4.9 ± 3.0 days). Pain score was significantly lower (P = 0.039) when L brevis was used [median (min-max): 0 (0-4) vs. 3 (0-5)]. OHIP-14 scores were not significantly different between treatments.
CONCLUSIONS
Lactobacillus brevis CD2 reduced almost 50% the persistence of traumatic oral lesions in patients with fixed orthodontics. Yet, there was no improvement in quality of life compared to placebo, suggesting that such differences in persistency and pain related to oral lesions may be considered clinically irrelevant.",2020,The oral lesions lasted significantly less time (P = 0.018) in patients treated with L brevis (2.5 ± 1.0 days) than with placebo (4.9 ± 3.0 days).,"['patients with fixed orthodontics', 'Twenty orthodontic patients (14-57 yo) were recruited from a private clinic']","['Lactobacillus brevis CD2', 'probiotic Lactobacillus brevis CD2', 'placebo', 'soluble tablets containing L brevis CD2 (4 billion colony-forming units after breakfast, lunch, and dinner) or placebo']","['early traumatic oral lesions', 'OHIP-14 scores', 'days with oral lesions and lesions-related pain [ranging between 0 (no pain) and 10 (maximum pain', 'quality of life', 'Oral health-related quality of life', 'Pain score', 'traumatic oral lesions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0317604', 'cui_str': 'Lactobacillus brevis'}, {'cui': 'C0108773', 'cui_str': 'Lymphocyte antigen CD2'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1550743', 'cui_str': 'After breakfast'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0149744', 'cui_str': 'Oral lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",70.0,0.595439,The oral lesions lasted significantly less time (P = 0.018) in patients treated with L brevis (2.5 ± 1.0 days) than with placebo (4.9 ± 3.0 days).,"[{'ForeName': 'Nathália Louize Nunes Vieira', 'Initials': 'NLNV', 'LastName': 'Silva', 'Affiliation': 'Postgraduate Program in Dentistry, Faculty of Dentistry, University of Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Della Bona', 'Affiliation': 'Postgraduate Program in Dentistry, Faculty of Dentistry, University of Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Moisés', 'Initials': 'M', 'LastName': 'Cardoso', 'Affiliation': 'Postgraduate Program in Dentistry, Faculty of Dentistry, University of Passo Fundo, Passo Fundo, RS, Brazil.'}, {'ForeName': 'Sidia Maria', 'Initials': 'SM', 'LastName': 'Callegari-Jacques', 'Affiliation': 'Statistics Department, Federal University of Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Fornari', 'Affiliation': 'Postgraduate Program in Dentistry, Faculty of Dentistry, University of Passo Fundo, Passo Fundo, RS, Brazil.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12448']
2255,33259643,"Effects of a whey protein pre-meal on bone turnover in participants with and without type 2 diabetes - a post hoc analysis of a randomized, controlled, crossover trial.","AIMS
Whey protein may improve bone turnover and have anti-osteoporotic effects. The aim of the present randomized, controlled, cross-over trial was to evaluate the effects of a whey protein pre-meal on bone turnover in people with type 2 diabetes and controls.
METHODS
Two groups, matched on sex, age, and body mass index, comprising 12 participants with and 12 participants without type 2 diabetes were randomly given a pre-meal of whey protein (20g) or water, which was consumed 15 min before a fat-rich meal or a fat-rich meal supplemented with 20g whey protein. During a 360-min period, postprandial responses in bone turnover were examined.
RESULTS
Osteocalcin, P-procollagen type 1 amino terminal propeptide (P1NP), C-terminal cross-linked telopeptide of type-I collagen (CTX), and parathyroid hormone (PTH) were lower at baseline and PTH, osteocalcin, and P1NP were lower during the entire postprandial phase in participants with type 2 diabetes than in participants without type 2 diabetes. We observed similar postprandial responses in bone turnover markers between persons with and without type 2 diabetes. We observed no effect of the whey protein or the water pre-meal on bone turnover markers. The changes were unrelated to secretion of hormones of the gut-bone axis.
CONCLUSION
Osteocalcin, P1NP, CTX, and PTH all decreased following meal ingestion. We observed no convincing effect of a whey protein pre-meal on bone turnover. However, these results confirm that people with type 2 diabetes have low bone turnover and that the decreased bone formation markers are also extend into the postprandial responses.",2020,"I collagen (CTX), and parathyroid hormone (PTH) were lower at baseline and PTH, osteocalcin, and P1NP were lower during the entire postprandial phase in participants with type 2 diabetes than in participants without type 2 diabetes.","['persons with and without type 2 diabetes', 'Two groups, matched on sex, age, and body mass index, comprising 12 participants with and 12 participants without type 2 diabetes', 'participants with and without type 2 diabetes ', 'people with type 2 diabetes and controls']","['pre-meal of whey protein (20g) or water, which was consumed 15 min before a fat-rich meal or a fat-rich meal supplemented with 20g whey protein', 'whey protein pre-meal']","['postprandial responses in bone turnover', 'Osteocalcin, P-procollagen type 1 amino terminal propeptide (P1NP', 'I collagen (CTX), and parathyroid hormone (PTH', 'bone turnover', 'bone turnover markers', 'bone formation markers']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0450403', 'cui_str': '20G'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",12.0,0.0270896,"I collagen (CTX), and parathyroid hormone (PTH) were lower at baseline and PTH, osteocalcin, and P1NP were lower during the entire postprandial phase in participants with type 2 diabetes than in participants without type 2 diabetes.","[{'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bjørnshave', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lykkeboe', 'Affiliation': 'Department of Clinical Biochemistry, Aalborg University Hospital.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'NNF Center for Basic Metabolic Research, University of Copenhagen.'}, {'ForeName': 'Jens Juul', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'NNF Center for Basic Metabolic Research, University of Copenhagen.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Starup-Linde', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14471']
2256,33259540,Core warming of coronavirus disease 2019 (COVID-19) patients undergoing mechanical ventilation-A protocol for a randomized controlled pilot study.,"BACKGROUND
Coronavirus disease 2019 (COVID-19), caused by the virus SARS-CoV-2, is spreading rapidly across the globe, with little proven effective therapy. Fever is seen in most cases of COVID-19, at least at the initial stages of illness. Although fever is typically treated (with antipyretics or directly with ice or other mechanical means), increasing data suggest that fever is a protective adaptive response that facilitates recovery from infectious illness.
OBJECTIVE
To describe a randomized controlled pilot study of core warming patients with COVID-19 undergoing mechanical ventilation.
METHODS
This prospective single-site randomized controlled pilot study will enroll 20 patients undergoing mechanical ventilation for respiratory failure due to COVID-19. Patients will be randomized 1:1 to standard-of-care or to receive core warming via an esophageal heat exchanger commonly utilized in critical care and surgical patients. The primary outcome is patient viral load measured by lower respiratory tract sample. Secondary outcomes include severity of acute respiratory distress syndrome (as measured by PaO2/FiO2 ratio) 24, 48, and 72 hours after initiation of treatment, hospital and intensive care unit length of stay, duration of mechanical ventilation, and 30-day mortality.
RESULTS
Resulting data will provide effect size estimates to guide a definitive multi-center randomized clinical trial. ClinicalTrials.gov registration number: NCT04426344.
CONCLUSIONS
With growing data to support clinical benefits of elevated temperature in infectious illness, this study will provide data to guide further understanding of the role of active temperature management in COVID-19 treatment and provide effect size estimates to power larger studies.",2020,Secondary outcomes include severity of acute respiratory distress syndrome (as measured by PaO2/FiO2 ratio),"['coronavirus disease 2019 (COVID-19) patients undergoing', '20 patients undergoing mechanical ventilation for respiratory failure due to COVID-19', 'core warming patients with COVID-19 undergoing mechanical ventilation']","['standard-of-care or to receive core warming via an esophageal heat exchanger commonly utilized in critical care and surgical patients', 'mechanical ventilation-A protocol']","['hospital and intensive care unit length of stay, duration of mechanical ventilation, and 30-day mortality', 'patient viral load measured by lower respiratory tract sample', 'severity of acute respiratory distress syndrome (as measured by PaO2/FiO2 ratio']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0444669', 'cui_str': 'Core'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0458579', 'cui_str': 'Lower respiratory tract structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",20.0,0.261207,Secondary outcomes include severity of acute respiratory distress syndrome (as measured by PaO2/FiO2 ratio),"[{'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Bonfanti', 'Affiliation': 'Department of Emergency Medicine, University of Texas, Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Gundert', 'Affiliation': 'Department of Emergency Medicine, University of Texas, Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Drewry', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, St. Louis, MO, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Goff', 'Affiliation': 'Department of Anesthesiology and Pain Management, University of Texas, Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Infectious Diseases Section, VA North Texas Health Care System, Dallas, TX, United States of America.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kulstad', 'Affiliation': 'Department of Emergency Medicine, University of Texas, Southwestern Medical Center, Dallas, TX, United States of America.'}]",PloS one,['10.1371/journal.pone.0243190']
2257,33259536,Use of GoPro point-of-view camera in intubation simulation-A randomized controlled trial.,"INTRODUCTION
Teaching endotracheal intubation is uniquely challenging due to its technical, high-stakes, and highly time-sensitive nature. The GoPro is a small, lightweight, high-resolution action camera with a wide-angle field of view that can encompass both the airway as well as the procedurist's hands and positioning technique when worn with a head mount. We aimed to evaluate its effectiveness in improving intubation teaching for novice learners in a simulated setting, via a two-arm, parallel group, randomized controlled superiority trial with 1:1 allocation ratio.
METHODS
We recruited Year 4 medical students at the start of their compulsory 2-week Anesthesia posting. Participants underwent a standardized intubation curriculum and a formative assessment, then randomized to receive GoPro or non-GoPro led feedback. After a span of three months, participants were re-assessed in a summative assessment by blinded accessors. Participants were also surveyed on their learning experience for a qualitative thematic perspective. The primary outcomes were successful intubation and successful first-pass intubation.
RESULTS
Seventy-one participants were recruited with no dropouts, and all were included in the analysis. 36 participants received GoPro led feedback, and 35 participants received non-GoPro led feedback. All participants successfully intubated the manikin. No statistically significant differences were found between the GoPro group and the non-GoPro group at summative assessment (85.3% vs 90.0%, p = 0.572). Almost all participants surveyed found the GoPro effective for their learning (98.5%). Common themes in the qualitative analysis were: the ability for an improved assessment, greater identification of small details that would otherwise be missed, and usefulness of the unique point-of-view footage in improving understanding.
CONCLUSIONS
The GoPro is a promising tool for simulation-based intubation teaching. There are considerations in its implementation to maximize the learning experience and yield from GoPro led feedback and training.",2020,"No statistically significant differences were found between the GoPro group and the non-GoPro group at summative assessment (85.3% vs 90.0%, p = 0.572).","['Seventy-one participants were recruited with no dropouts, and all were included in the analysis', '36 participants received', 'We recruited Year 4 medical students at the start of their compulsory 2-week Anesthesia posting']","['GoPro led feedback, and 35 participants received non-GoPro led feedback', 'GoPro point-of-view camera', 'standardized intubation curriculum', 'GoPro or non-GoPro led feedback']",['successful intubation and successful first-pass intubation'],"[{'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0444693', 'cui_str': 'First pass'}]",71.0,0.16871,"No statistically significant differences were found between the GoPro group and the non-GoPro group at summative assessment (85.3% vs 90.0%, p = 0.572).","[{'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Koh', 'Affiliation': 'Department of Anaesthesia, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Khoo', 'Affiliation': 'Department of Anaesthesia, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Ling Te Terry', 'Initials': 'LTT', 'LastName': 'Pan', 'Affiliation': 'Department of Anaesthesia, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Lyn Li', 'Initials': 'LL', 'LastName': 'Lean', 'Affiliation': 'Department of Anaesthesia, National University Health System, Singapore, Singapore.'}, {'ForeName': 'May-Han', 'Initials': 'MH', 'LastName': 'Loh', 'Affiliation': 'Department of Anaesthesia, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Tze Yuh Vanessa', 'Initials': 'TYV', 'LastName': 'Chua', 'Affiliation': 'Department of Anaesthesia, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Lian Kah', 'Initials': 'LK', 'LastName': 'Ti', 'Affiliation': 'Department of Anaesthesia, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}]",PloS one,['10.1371/journal.pone.0243217']
2258,33259482,Effects of vitamin B12 supplementation on neurodevelopment and growth in Nepalese Infants: A randomized controlled trial.,"BACKGROUND
Vitamin B12 deficiency is common and affects cell division and differentiation, erythropoiesis, and the central nervous system. Several observational studies have demonstrated associations between biomarkers of vitamin B12 status with growth, neurodevelopment, and anemia. The objective of this study was to measure the effects of daily supplementation of vitamin B12 for 1 year on neurodevelopment, growth, and hemoglobin concentration in infants at risk of deficiency.
METHODS AND FINDINGS
This is a community-based, individually randomized, double-blind placebo-controlled trial conducted in low- to middle-income neighborhoods in Bhaktapur, Nepal. We enrolled 600 marginally stunted, 6- to 11-month-old infants between April 2015 and February 2017. Children were randomized in a 1:1 ratio to 2 μg of vitamin B12, corresponding to approximately 2 to 3 recommended daily allowances (RDAs) or a placebo daily for 12 months. Both groups were also given 15 other vitamins and minerals at around 1 RDA. The primary outcomes were neurodevelopment measured by the Bayley Scales of Infant and Toddler Development 3rd ed. (Bayley-III), attained growth, and hemoglobin concentration. Secondary outcomes included the metabolic response measured by plasma total homocysteine (tHcy) and methylmalonic acid (MMA). A total of 16 children (2.7%) in the vitamin B12 group and 10 children (1.7%) in the placebo group were lost to follow-up. Of note, 94% of the scheduled daily doses of vitamin B12 or placebo were reported to have been consumed (in part or completely). In this study, we observed that there were no effects of the intervention on the Bayley-III scores, growth, or hemoglobin concentration. Children in both groups grew on an average 12.5 cm (SD: 1.8), and the mean difference was 0.20 cm (95% confidence interval (CI): -0.23 to 0.63, P = 0.354). Furthermore, at the end of the study, the mean difference in hemoglobin concentration was 0.02 g/dL (95% CI: -1.33 to 1.37, P = 0.978), and the difference in the cognitive scaled scores was 0.16 (95% CI: -0.54 to 0.87, P = 0.648). The tHcy and MMA concentrations were 23% (95% CI: 17 to 30, P < 0.001) and 30% (95% CI: 15 to 46, P < 0.001) higher in the placebo group than in the vitamin B12 group, respectively. We observed 43 adverse events in 36 children, and these events were not associated with the intervention. In addition, 20 in the vitamin B12 group and 16 in the placebo group were hospitalized during the supplementation period. Important limitations of the study are that the strict inclusion criteria could limit the external validity and that the period of vitamin B12 supplementation might not have covered a critical window for infant growth or brain development.
CONCLUSIONS
In this study, we observed that vitamin B12 supplementation in young children at risk of vitamin B12 deficiency resulted in an improved metabolic response but did not affect neurodevelopment, growth, or hemoglobin concentration. Our results do not support widespread vitamin B12 supplementation in marginalized infants from low-income countries.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02272842 Universal Trial Number: U1111-1161-5187 (September 8, 2014) Trial Protocol: Original trial protocol: PMID: 28431557 (reference [18]; study protocols and plan of analysis included as Supporting information).",2020,"The tHcy and MMA concentrations were 23% (95% CI: 17 to 30, P < 0.001) and 30% (95% CI: 15 to 46, P < 0.001) higher in the placebo group than in the vitamin B12 group, respectively.","['36 children', 'Nepalese Infants', 'young children at risk of vitamin B12 deficiency', 'low- to middle-income neighborhoods in Bhaktapur, Nepal', '16 children (2.7%) in the vitamin B12 group and 10 children (1.7%) in the', 'NCT02272842 Universal Trial Number: U1111-1161-5187 (September 8, 2014', 'infants at risk of deficiency', '6- to 11-month-old infants between April 2015 and February 2017']","['vitamin B12', 'placebo', 'vitamin B12 or placebo', 'vitamin B12, corresponding to approximately 2 to 3 recommended daily allowances (RDAs) or a placebo', 'vitamin B12 supplementation']","['Bayley-III scores, growth, or hemoglobin concentration', 'tHcy and MMA concentrations', 'attained growth, and hemoglobin concentration', 'hemoglobin concentration', 'neurodevelopment, growth, or hemoglobin concentration', 'metabolic response', 'cognitive scaled scores', 'neurodevelopment and growth', 'neurodevelopment measured by the Bayley Scales of Infant and Toddler Development 3rd ed', 'metabolic response measured by plasma total homocysteine (tHcy) and methylmalonic acid (MMA', 'neurodevelopment, growth, and hemoglobin concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0042847', 'cui_str': 'Cobalamin deficiency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0524786', 'cui_str': 'Recommended Daily Allowance'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}]","[{'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205437', 'cui_str': 'Third'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}]",600.0,0.520227,"The tHcy and MMA concentrations were 23% (95% CI: 17 to 30, P < 0.001) and 30% (95% CI: 15 to 46, P < 0.001) higher in the placebo group than in the vitamin B12 group, respectively.","[{'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hospital Trust, Department of Research, Lillehammer, Norway.'}, {'ForeName': 'Manjeswori', 'Initials': 'M', 'LastName': 'Ulak', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hysing', 'Affiliation': 'Department of Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Ranjitkar', 'Affiliation': 'Department of Pediatrics, Child Health Research Project, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Center for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Centre, Bergen, Norway.'}, {'ForeName': 'Merina', 'Initials': 'M', 'LastName': 'Shrestha', 'Affiliation': 'Department of Pediatrics, Child Health Research Project, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Prakash S', 'Initials': 'PS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Pediatrics, Child Health Research Project, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Laxman S', 'Initials': 'LS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Pediatrics, Child Health Research Project, Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Chandyo', 'Affiliation': 'Department of Community Medicine, Kathmandu Medical College, Kathmandu, Nepal.'}]",PLoS medicine,['10.1371/journal.pmed.1003430']
2259,33259474,Perturbation of the human gastrointestinal tract microbial ecosystem by oral drugs to treat chronic disease results in a spectrum of individual specific patterns of extinction and persistence of dominant microbial strains.,"BACKGROUND
Oral drugs can have side effects such as diarrhea that indicate the perturbation of the gut microbial community. To further understand the dynamics of perturbation, we have assessed the strain relatedness of samples from previously published data sets from pre and post bowel evacuation, episodes of diarrhea, and administration of oral drugs to treat diabetes and rheumatoid arthritis.
METHODS
We analyzed a total of published five data sets using our strain-tracking tool called Window-based Single Nucleotide Variant (SNV) Similarity (WSS) to identify related strains from the same individual.
RESULTS
Strain-tracking analysis using the first data set from 8 individuals pre and 21-50 days post iso-osmotic bowel wash revealed almost all microbial strains were related in an individual between pre and post samples. Similarly, in a second study, strain-tracking analysis of 4 individuals pre and post sporadic diarrhea revealed the majority of strains were related over time (up to 44 weeks). In contrast, the analysis of a third data set from 22 individuals pre and post 3-day exposure of oral metformin revealed that no individuals had a related strain. In a fourth study, the data set taken at 2 and 4 months from 38 individuals on placebo or metformin revealed individual specific sharing of pre and post strains. Finally, the data set from 18 individuals with rheumatoid arthritis given disease-modifying antirheumatic drugs methotrexate or glycosides of the traditional Chinese medicinal component Tripterygium wilfordii showed individual specific sharing of pre and post strains up to 16 months.
CONCLUSION
Oral drugs used to treat chronic disease can result in individual specific microbial strain change for the majority of species. Since the gut community provides essential functions for the host, our study supports personalized monitoring to assess the status of the dominant microbial strains after initiation of oral drugs to treat chronic disease.",2020,"RESULTS
Strain-tracking analysis using the first data set from 8 individuals pre and 21-50 days post iso-osmotic bowel wash revealed almost all microbial strains were related in an individual between pre and post samples.","['18 individuals with rheumatoid arthritis given disease-modifying antirheumatic drugs methotrexate or glycosides of the traditional Chinese medicinal component Tripterygium wilfordii', '38 individuals on']","['strain-tracking tool called Window-based Single Nucleotide Variant (SNV) Similarity (WSS', 'placebo or metformin', 'metformin']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0007158', 'cui_str': 'Glycoside'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0077273', 'cui_str': 'Leigong Teng'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0028630', 'cui_str': 'Nucleotide'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]",[],,0.0339208,"RESULTS
Strain-tracking analysis using the first data set from 8 individuals pre and 21-50 days post iso-osmotic bowel wash revealed almost all microbial strains were related in an individual between pre and post samples.","[{'ForeName': 'Hyunmin', 'Initials': 'H', 'LastName': 'Koo', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}, {'ForeName': 'Casey D', 'Initials': 'CD', 'LastName': 'Morrow', 'Affiliation': 'Department of Cell, Developmental and Integrative Biology, University of Alabama at Birmingham, Birmingham, Alabama, United States of America.'}]",PloS one,['10.1371/journal.pone.0242021']
2260,33259459,Open-label placebo for chronic low back pain: a 5-year follow-up.,"Long-term follow-up of patients treated with open-label placebo (OLP) are non-existent. Herein, we report a 5-year follow-up of a three-weeks OLP randomized controlled trial (RCT) in chronic low back pain patients. We re-contacted the original participants of original RCT and reassessed their pain, disability, and use of pain medication. We obtained follow-up data from 55 participants (82% of those who took OLP during the parent RCT), with a mean elapsed time between the end of the 3-weeks placebo trial and the follow-up interview of 55 months (SD=7.85). We found significant reductions in both pain and disability between the baseline assessment immediately before the three-weeks trial with placebo pills and the original trial endpoint (p < .00001 for the two primary outcomes of pain and disability). At the 5-year follow-up, we found no significant differences in either outcome between original trial endpoint and follow-up. Improvements persisted after 5-years and were accompanied by substantial reductions compared to baseline in the use of pain medication (from 87% to 38%), comprising analgesics (from 80% to 31%) antidepressants (from 24% to 11%), and benzodiazepines (from 15% to 5%). In contrast, the use of alternative approaches to pain management increased (from 18% to 29%). Although the reduction in pain and medication is comparable to the improvements that occurred in the original study, a major limitation of this long-term follow-up is the absence of controls for spontaneous improvement and new co-interventions. Nonetheless, our data suggest that reductions in pain and disability following OLP may be long lasting.",2020,"Improvements persisted after 5-years and were accompanied by substantial reductions compared to baseline in the use of pain medication (from 87% to 38%), comprising analgesics (from 80% to 31%) antidepressants (from 24% to 11%), and benzodiazepines (from 15% to 5%).","['chronic low back pain patients', 'chronic low back pain']","['open-label placebo (OLP', 'Open-label placebo', 'benzodiazepines', 'placebo']","['pain medication', 'pain management', 'pain and medication', 'pain and disability']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.140407,"Improvements persisted after 5-years and were accompanied by substantial reductions compared to baseline in the use of pain medication (from 87% to 38%), comprising analgesics (from 80% to 31%) antidepressants (from 24% to 11%), and benzodiazepines (from 15% to 5%).","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Carvalho', 'Affiliation': 'ISPA - Instituto Universitário de Ciências Psicológicas, Sociais e da Vida, Rua Jardim do Tabaco, 34, 1149-041 Lisbon, Portugal.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pais', 'Affiliation': 'Santa Casa da Misericórdia de Lisboa. Largo Trindade Coelho, 1200-470 Lisbon, Portugal.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Cunha', 'Affiliation': 'Unidade de Terapia de Dor do Hospital de Egas Moniz / Centro Hospitalar de Lisboa Ocidental. Rua Da Junqueira 126, 1349-019 Lisbon, Portugal.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Rebouta', 'Affiliation': 'Unidade de Terapia de Dor do Hospital de Egas Moniz / Centro Hospitalar de Lisboa Ocidental. Rua Da Junqueira 126, 1349-019 Lisbon, Portugal.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, 330 Brookline Avenue, Boston, USA.'}]",Pain,['10.1097/j.pain.0000000000002162']
2261,33259454,Effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants: A randomised controlled trial.,"BACKGROUND
Hypoxaemia occurs frequently in infants during anaesthetic induction.
OBJECTIVE
We evaluated the effect of positive end-expiratory pressure during anaesthesia induction on nonhypoxic apnoea time in infants.
DESIGN
Randomised controlled trial.
SETTING
Tertiary care children's hospital, single centre, from November 2018 to October 2019.
PATIENTS
We included patients under 1 year of age receiving general anaesthesia.
INTERVENTION
We assigned infants to a 7 cmH2O or 0 cmH2O positive end-expiratory pressure group. Anaesthesia was induced with 0.02 mg kg atropine, 5 mg kg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6 mg kg rocuronium. Thereafter, 100% oxygen was provided via face mask with volume-controlled ventilation of 6 ml kg tidal volume, and either 7 cmH2O or no positive end-expiratory pressure. After 3 min of ventilation, the infants' trachea was intubated but disconnected from the breathing circuit, and ventilation resumed when pulse oximetry reached 95%.
MAIN OUTCOME MEASURE
The primary outcome was nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading of 95%, whereas the secondary outcome was the incidence of significant atelectasis (consolidation score ≥2) assessed by lung ultrasound.
RESULTS
Sixty patients were included in the final analysis. Apnoea time in the 7 cmH2O positive end-expiratory pressure group (105.2 s) increased compared with that in the control group (92.1 s) (P = 0.011, mean difference 13.0 s, 95% CI, 3.1 to 22.9 s). Significant atelectasis was observed in all patients without positive end-expiratory pressure and 66.7% of those with 7 cmH2O positive end-expiratory pressure (P = 0.019, 95% CI, 1.7 to 563.1, odds ratio 31.2).
CONCLUSION
Positive end-expiratory pressure during anaesthesia induction with face mask ventilation increased nonhypoxic apnoea time in infants.
CLINICAL TRIAL REGISTRATION
www.clinicaltrials.gov, NCT03540940.",2020,"(P = 0.011, mean difference 13.0 s, 95% CI, 3.1 to 22.9 s).","['Sixty patients were included in the final analysis', 'infants during anaesthetic induction', 'We included patients under 1 year of age receiving general anaesthesia', 'infants', ""Tertiary care children's hospital, single centre, from November 2018 to October 2019""]","['positive end-expiratory pressure during anaesthesia induction', '7\u200acmH2O or 0\u200acmH2O positive end-expiratory pressure group', 'atropine, 5\u200amg\u200akg thiopental sodium and 3 to 5% sevoflurane, and neuromuscular blockade with 0.6\u200amg\u200akg rocuronium']","['Significant atelectasis', 'expiratory pressure', 'nonhypoxic apnoea time defined as the time from cessation of ventilation to a pulse oximeter reading', 'nonhypoxic apnoea time', 'incidence of significant atelectasis (consolidation score ≥2) assessed by lung ultrasound', 'Apnoea time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}]","[{'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0004144', 'cui_str': 'Atelectasis'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}]",60.0,0.52979,"(P = 0.011, mean difference 13.0 s, 95% CI, 3.1 to 22.9 s).","[{'ForeName': 'Eun-Hee', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'From the Department of Anaesthesiology and Pain medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea (EH-K, JH-L, YE-J, SH-J, SA-C, JT-K, HS-K).'}, {'ForeName': 'Ji-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Sang-Hwan', 'Initials': 'SH', 'LastName': 'Ji', 'Affiliation': ''}, {'ForeName': 'Sung-Ae', 'Initials': 'SA', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Hee-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001400']
2262,33259452,The efficacy of high flow nasal oxygenation for maintaining maternal oxygenation during rapid sequence induction in pregnancy: A prospective randomised clinical trial.,"BACKGROUND
High-flow nasal oxygenation (HFNO) for pre-oxygenation in rapid sequence induction (RSI) has only been assessed in volunteer parturients without intubation.
OBJECTIVES
To evaluate the efficacy of HFNO in comparison with the conventional facemask for oxygenation during RSI for caesarean section under general anaesthesia.
SETTING
Operating room in a tertiary hospital.
DESIGN
Prospective randomised, controlled study.
PARTICIPANTS
Thirty-four healthy parturients undergoing general anaesthesia for caesarean section.
INTERVENTIONS
Parturients were randomly assigned to HFNO or standard facemask (SFM) group.
MAIN OUTCOME MEASURES
The primary outcome measure was the PaO2 immediately after intubation. Secondary outcomes included lowest saturation throughout the intubation procedure, end-tidal oxygen concentration (EtO2) on commencing ventilation, blood gas analysis (pH, PaCO2), fetal outcomes and intubation-related adverse events.
RESULTS
PaO2 in the HFNO group was significantly higher than that in SFM group (441.41 ± 46.73 mmHg versus 328.71 ± 72.80 mmHg, P < 0.0001). The EtO2 concentration in the HFNO group was higher than that in the SFM group (86.71 ± 4.12% versus 76.94 ± 7.74%, P < 0.0001). Compared to baseline, PaCO2 immediately after intubation also increased significantly in both groups (HFNO group: 30.87 ± 2.50 mmHg versus 38.28 ± 3.18 mmHg; SFM group: 29.82 ± 2.57 mmHg versus 38.05 ± 5.76 mmHg, P < 0.0001), but there was no difference in PaCO2 between the two groups. There was no difference in lowest saturation, intubation times, duration of apnoea, pH value or fetal outcomes.
CONCLUSIONS
Compared with SFM, HFNO provided a higher PaO2 and EtO2 immediately after intubation in parturients. HFNO is safe as a method of oxygenation during RSI in parturients undergoing general anaesthesia for caesarean section.
TRIAL REGISTRATION
Clinical trial ChiCTR1900023121.",2020,"Compared with SFM, HFNO provided a higher PaO2 and EtO2 immediately after intubation in parturients.","['volunteer parturients without intubation', 'Operating room in a tertiary hospital', 'pregnancy', 'Thirty-four healthy parturients undergoing general anaesthesia for caesarean section', 'parturients undergoing general anaesthesia for caesarean section']","['High-flow nasal oxygenation (HFNO', 'HFNO or standard facemask (SFM) group', 'high flow nasal oxygenation', 'conventional facemask', 'SFM', 'HFNO', 'SFM, HFNO']","['PaO2 immediately after intubation', 'lowest saturation, intubation times, duration of apnoea, pH value or fetal outcomes', 'lowest saturation throughout the intubation procedure, end-tidal oxygen concentration (EtO2) on commencing ventilation, blood gas analysis (pH, PaCO2), fetal outcomes and intubation-related adverse events', 'PaCO2', 'EtO2 concentration']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0029064', 'cui_str': 'Operating theatre'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0428651', 'cui_str': 'End tidal oxygen concentration'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",34.0,0.202379,"Compared with SFM, HFNO provided a higher PaO2 and EtO2 immediately after intubation in parturients.","[{'ForeName': 'Shuangqiong', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiuhong', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'From the Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Ni', 'Affiliation': 'From the Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Weijia', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'From the Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'From the Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Anaesthesiology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine, Shanghai, China.'}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001395']
2263,33259451,Efficacy of intra-operative administration of iron isomaltoside for preventing postoperative anaemia after total knee arthroplasty: A randomised controlled trial.,"BACKGROUND
Postoperative anaemia is common after total knee arthroplasty (TKA). Emerging evidence shows the beneficial effects of peri-operative iron supplementation in patients at risk of postoperative anaemia.
OBJECTIVE
To evaluate the efficacy of intra-operative administration of iron isomaltoside for the prevention of postoperative anaemia in patients undergoing TKA.
DESIGN
Randomised, controlled, double-blind, parallel-group study.
SETTING
A tertiary care teaching hospital; between 29 March 2018 and 16 April 2019.
PATIENTS
Eighty-nine patients scheduled for unilateral TKA were included.
INTERVENTION
Iron isomaltoside or placebo were administered intravenously over 30 min during surgical wound closure.
MAIN OUTCOME MEASURES
The primary outcome measure was the incidence of anaemia at 30 days after TKA: anaemia was defined as haemoglobin less than 12 g dl for female and less than 13 g dl for male.
RESULTS
In total, 89 patients were included in the final analysis (44 in the treatment group; 45 in the control group). The administered dose of iron isomaltoside in the treatment group was 1136 ± 225 mg. The incidence of anaemia at 30 days after TKA was significantly lower in the treatment group (34.1%, 15/44) than that in the control group (62.2%, 28/45): relative risk 0.55 (95% confidence interval, 0.34 to 0.88), P = 0.008. Haemoglobin concentration, serum ferritin concentrations, and transferrin saturation were also significantly higher in the treatment group at 30 days after TKA.
CONCLUSION
The intra-operative administration of iron isomaltoside effectively prevents postoperative anaemia in patients undergoing TKA, and thus it can be included in patient blood management protocols for reducing postoperative anaemia in these population.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03470649.",2020,"Haemoglobin concentration, serum ferritin concentrations, and transferrin saturation were also significantly higher in the treatment group at 30 days after TKA.
","['after total knee arthroplasty', 'Eighty-nine patients scheduled for unilateral TKA were included', 'patients undergoing TKA', 'A tertiary care teaching hospital; between 29 March 2018 and 16 April 2019', 'total knee arthroplasty (TKA', 'patients at risk of postoperative anaemia', '89 patients were included in the final analysis (44 in the treatment group; 45 in the control group', 'g\u200adl for female and less than 13']","['intra-operative administration of iron isomaltoside', 'peri-operative iron supplementation', 'Iron isomaltoside or placebo', 'iron isomaltoside']","['incidence of anaemia', 'Haemoglobin concentration, serum ferritin concentrations, and transferrin saturation', 'postoperative anaemia', 'incidence of anaemia at 30 days after TKA: anaemia']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]",89.0,0.585269,"Haemoglobin concentration, serum ferritin concentrations, and transferrin saturation were also significantly higher in the treatment group at 30 days after TKA.
","[{'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'From the Department of Anaesthesiology and Pain Medicine (SY, JB, S-KP, Y-JL, J-HB, J-TK) and the Department of Orthopaedic Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea (DHR, H-SH, MCL).'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Du H', 'Initials': 'DH', 'LastName': 'Ro', 'Affiliation': ''}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Myung C', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Jae-Hyon', 'Initials': 'JH', 'LastName': 'Bahk', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001389']
2264,33259449,Effect of dexmedetomidine on Nociception Level Index-guided remifentanil antinociception: A randomised controlled trial.,"BACKGROUND
The effect of dexmedetomidine on Nociception Level Index (Medasense, Israel) antinociception to reduce intra-operative opioid requirements has not been previously investigated.
OBJECTIVE
We aimed to determine if low-dose dexmedetomidine would reduce remifentanil requirements during Nociception Level Index-guided antinociception without increasing complications associated with dexmedetomidine.
DESIGN
Double-blind randomised controlled trial.
SETTING
Two university teaching hospitals in Brussels, Belgium.
PATIENTS
American Society of Anesthesiologists 1 and 2 patients (n = 58) undergoing maxillofacial or cervicofacial surgery under propofol--remifentanil target-controlled infusion anaesthesia.
INTERVENTIONS
A 30 min infusion of dexmedetomidine, or equal volume of 0.9% NaCl, was infused at 1.2 μg kg h immediately preceding induction and then decreased to 0.6 μg kg h until 30 min before ending surgery. Nociception Level Index and frontal electroencephalogram guided the remifentanil and propofol infusions, respectively.
MAIN OUTCOMES
The primary outcome was the remifentanil requirement. Other outcomes included the propofol requirement, cardiovascular status and postoperative outcome.
RESULTS
Mean ± SD remifentanil (3.96 ± 1.95 vs. 4.42 ± 2.04 ng ml; P = 0.0024) and propofol (2.78 ± 1.36 vs. 3.06 ± 1.29 μg ml; P = 0.0046) TCI effect site concentrations were lower in the dexmedetomidine group at 30 min postincision and remained lower throughout surgery. When remifentanil (0.133 ± 0.085 vs. 0.198 ± 0.086 μg kg min; P = 0.0074) and propofol (5.7 ± 2.72 vs. 7.4 ± 2.80 mg kg h; P = 0.0228) requirements are represented as infusion rates, this effect became statistically significant at 2 h postincision.
CONCLUSION
In ASA 1 and 2 patients receiving Nociception Level Index-guided antinociception, dexmedetomidine decreases intra-operative remifentanil requirements. Combined frontal electroencephalogram and Nociception Level Index monitoring can measure dexmedetomidine's hypnotic and opioid-sparing effects during remifentanil-propofol target-controlled infusion anaesthesia.
TRIAL REGISTRATIONS
Clinicaltrials.gov: NCT03912740, EudraCT: 2018-004512-22.",2020,TCI effect site concentrations were lower in the dexmedetomidine group at 30 min postincision and remained lower throughout surgery.,"['Two university teaching hospitals in Brussels, Belgium', 'American Society of Anesthesiologists 1 and 2 patients (n\u200a=\u200a58) undergoing maxillofacial or cervicofacial surgery under propofol--remifentanil target-controlled infusion anaesthesia']","['dexmedetomidine', 'dexmedetomidine, or equal volume of 0.9% NaCl', 'remifentanil', 'propofol', 'remifentanil and propofol', 'remifentanil-propofol']","['Mean\u200a±\u200aSD remifentanil (3.96\u200a±', 'propofol requirement, cardiovascular status and postoperative outcome', 'TCI effect site concentrations', 'remifentanil requirement', 'Nociception Level Index']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C3163670', 'cui_str': 'Target controlled total intravenous anesthesia'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",58.0,0.525452,TCI effect site concentrations were lower in the dexmedetomidine group at 30 min postincision and remained lower throughout surgery.,"[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Coeckelenbergh', 'Affiliation': 'From the Department of Anaesthesiology, Erasme University Hospital, Université Libre de Bruxelles, Brussels, Belgium (SC, SD, LP, EE, LVO, LB), Department of Anaesthesiology, Saint Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium (SC, DP, LDM, PK), EW Data Analysis, Brussels, Belgium (EE), Department of Ear-Nose-Throat Surgery, Saint Pierre University Hospital, Université Libre de Bruxelles, Brussels, Belgium (AR) and Department of Anaesthesiology, CHU Rennes, Université de Rennes, Rennes, France (JP-E).'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Doria', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Patricio', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Perrin', 'Affiliation': ''}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'Engelman', 'Affiliation': ''}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'Livia', 'Initials': 'L', 'LastName': 'Di Marco', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Van Obbergh', 'Affiliation': ''}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Estebe', 'Affiliation': ''}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Barvais', 'Affiliation': ''}, {'ForeName': 'Panayota', 'Initials': 'P', 'LastName': 'Kapessidou', 'Affiliation': ''}]",European journal of anaesthesiology,['10.1097/EJA.0000000000001402']
2265,33259430,Comparison of Joint Perception Between Posterior-Stabilized and Ultracongruent Total Knee Arthroplasty in the Same Patient.,"BACKGROUND
Posterior-stabilized and ultracongruent designs are 2 common examples of posterior cruciate ligament-substituting total knee arthroplasty (TKA) prostheses. There is a lack of evidence regarding joint perception differences between ultracongruent and posterior-stabilized TKA. The purpose of this study was to compare the postoperative knee stability, function, and joint perception between ultracongruent and posterior-stabilized TKA in the same patients in order to determine whether there was a difference based on design.
METHODS
This prospective, randomized controlled trial included 50 patients who underwent same-day bilateral TKA utilizing Persona (Zimmer Biomet) posterior-stabilized implants in 1 knee (posterior-stabilized group) and ultracongruent implants in the other knee (ultracongruent group). At 2 years postoperatively, patients were evaluated for knee stability, function, and joint perception. Postoperative static knee anteroposterior stability and femoral rollback were compared. Knee function was evaluated with use of the Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Joint perception was compared by evaluating noise generation, side preference, satisfaction, and the Forgotten Joint Score.
RESULTS
The ultracongruent group had more knee anteroposterior laxity (4.5 mm compared with 1.8 mm in the posterior-stabilized group; p < 0.001) and less femoral rollback (4.2 mm compared with 9.0 mm in the posterior-stabilized group; p < 0.001). Knee Society Score and WOMAC scores were not significantly different between groups (all p > 0.05). Although the ultracongruent group showed less noise generation than the posterior-stabilized group (18% compared with 38%, respectively; p = 0.026), there were no differences in side preference, satisfaction, or Forgotten Joint Score (all p > 0.05).
CONCLUSIONS
Both groups had similar joint perception 2 years postoperatively, with obvious differences in noise generation and more sagittal laxity with less femoral rollback in the ultracongruent group.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,Knee Society Score and WOMAC scores were not significantly different between groups (all p > 0.05).,"['posterior cruciate ligament-substituting total knee arthroplasty (TKA) prostheses', '50 patients who underwent same-day bilateral TKA utilizing Persona (Zimmer Biomet) posterior-stabilized implants in 1 knee (posterior-stabilized group) and ultracongruent implants in the other knee (ultracongruent group']",[],"['noise generation and more sagittal laxity with less femoral rollback', 'noise generation, side preference, satisfaction, and the Forgotten Joint Score', 'noise generation', 'Knee function', 'femoral rollback', 'Knee Society Score and Western Ontario and McMaster Universities Osteoarthritis Index', 'postoperative knee stability, function, and joint perception', 'side preference, satisfaction, or Forgotten Joint Score', 'Joint perception', 'knee anteroposterior laxity', 'knee stability, function, and joint perception', 'Knee Society Score and WOMAC scores', 'Postoperative static knee anteroposterior stability and femoral rollback']","[{'cui': 'C0080039', 'cui_str': 'Structure of posterior cruciate ligament of knee joint'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0085898', 'cui_str': 'Biomet'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C4759288', 'cui_str': 'Forgotten Joint Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",50.0,0.0804047,Knee Society Score and WOMAC scores were not significantly different between groups (all p > 0.05).,"[{'ForeName': 'Man Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'In Jun', 'Initials': 'IJ', 'LastName': 'Koh', 'Affiliation': ""Department of Orthopaedic Surgery, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Chul Kyu', 'Initials': 'CK', 'LastName': 'Kim', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Keun Young', 'Initials': 'KY', 'LastName': 'Choi', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jin Hwa', 'Initials': 'JH', 'LastName': 'Jeon', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'In', 'Affiliation': ""Department of Orthopaedic Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00279']
2266,33259428,Day-of-Surgery Video Calls and Phone Calls Increase Patient Satisfaction with Outpatient Surgery Experience: A Randomized Controlled Trial of Postoperative Communication Modalities.,"BACKGROUND
With the increasing utilization of patient satisfaction as a metric for clinical care, there is growing interest in techniques that can be used to improve satisfaction in patients undergoing surgery. The purpose of this trial was to assess the impact of day-of-surgery video and phone calls on patient satisfaction.
METHODS
We enrolled 251 patients undergoing outpatient orthopaedic surgery with 3 participating surgeons. Surgeons were randomized to 1 of 3 patient communication modalities: no contact (standard of care), phone call, or video call. Several hours following discharge on the day of surgery, the surgeons contacted patients according to their assigned treatment group. At the initial postoperative office visit, satisfaction outcomes were assessed using the Consumer Assessment of Healthcare Providers and Systems Surgical Care (S-CAHPS) survey and an additional satisfaction questionnaire.
RESULTS
Fifty-nine (97%) of 61 patients in the no-contact group, 118 (99%) of 119 patients in the phone group, and 71 (100%) of 71 patients in the video group completed follow-up assessment. The S-CAHPS top-box response rate in both the video group (0.86 ± 0.14, p < 0.001) and the phone group (0.84 ± 0.17, p < 0.001) was greater than in the no-contact group (0.68 ± 0.26). When asked to rate satisfaction with overall care, a greater proportion of patients in the video group (85.9%) gave the top-box response compared with both the phone group (71.8%, p = 0.040) and the no-contact group (60.7%, p = 0.002). Among the patients in the video group, 62.0% indicated that they would prefer a video call in future encounters with their surgeon compared with 1.8% of patients in the no-contact group (p < 0.001) and 1.7% of patients in the phone group (p < 0.001).
CONCLUSIONS
Phone and video calls following discharge are an effective way of enhancing patient satisfaction with the clinical care experience as measured by the S-CAHPS survey. In terms of satisfaction with overall care, video calls may be superior to phone calls.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"When asked to rate satisfaction with overall care, a greater proportion of patients in the video group (85.9%) gave the top-box response compared with both the phone group (71.8%, p = 0.040) and the no-contact group (60.7%, p = 0.002).","['251 patients undergoing outpatient orthopaedic surgery with 3 participating surgeons', 'patients undergoing surgery', 'Increase Patient Satisfaction with Outpatient Surgery Experience']","['patient communication modalities: no contact (standard of care), phone call, or video call', 'surgery video and phone calls', 'Day-of-Surgery Video Calls and Phone Calls']","['Consumer Assessment of Healthcare Providers and Systems Surgical Care', 'S-CAHPS top-box response rate']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}]",251.0,0.104985,"When asked to rate satisfaction with overall care, a greater proportion of patients in the video group (85.9%) gave the top-box response compared with both the phone group (71.8%, p = 0.040) and the no-contact group (60.7%, p = 0.002).","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Kingery', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hoberman', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Baron', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Gonzalez-Lomas', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY.'}, {'ForeName': 'Laith M', 'Initials': 'LM', 'LastName': 'Jazrawi', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Alaia', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Strauss', 'Affiliation': 'Department of Orthopedic Surgery, NYU Langone Orthopedic Hospital, New York, NY.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00426']
2267,33259351,Effects of Mindfulness-Based Stress Reduction on Experimental Pain Sensitivity and Cortisol Responses in Women with Early Life Abuse: A Randomized Controlled Trial.,"OBJECTIVE
Early life abuse (ELAb) initiates pathophysiological cascades resulting in long-term maladaptive stress responsivity, hyperalgesia and an increased risk for psychopathology. Mindfulness-based stress reduction (MBSR) is effective in modifying psychological and somatic symptoms; thus, we predicted that MBSR would be particularly efficacious for women with ELAb.
METHOD
Medically healthy women (mean age=31) with or without a history of early (≤13 years) physical or sexual abuse provided self-report measures and were tested in the laboratory before and after randomization to standard MBSR (n=52) or social support (SSG) (n=60) for 8 weeks. The laboratory procedure involved pain testing using the cold pressor and temporal summation of heat pain (indexing central sensitization) procedures, and exposure to the Trier Social Stress Test. Plasma cortisol in response to the experimental protocol was assessed as area under the curve (AUC).
RESULTS
The interventions differentially impacted pain sensitivity and cortisol-AUC for women with ELAb, as MBSR increased temporal summation of heat pain intensity ratings (p=.024) and reduced cortisol-AUC (p=.004). For women without ELAb, MBSR decreased cold pressor tolerance (p=.045) and decreased temporal summation of heat pain intensity ratings relative to SSG (p=.024). Both MBSR and SSG improved depression symptoms and emotion regulation abilities (ps<0.001); however, MBSR was associated with greater benefits in describing emotions (p=.008) and impulse control (p=.017) for women with ELAb.
CONCLUSIONS
Women with ELAb benefited from MBSR-specific improvements in central sensitization, mindfulness skills and emotion regulation abilities. This is the first study to examine the efficacy of MBSR in modifying affective and somatic symptoms based on ELAb status, and provides evidence for considering ELAb in tailoring treatment approaches.Trial RegistrationClinicalTrials.gov Identifier: NCT01995916; https://clinicaltrials.gov/ct2/show/NCT01995916.",2020,"Both MBSR and SSG improved depression symptoms and emotion regulation abilities (ps<0.001); however, MBSR was associated with greater benefits in describing emotions (p=.008) and impulse control (p=.017) for women with ELAb.
","['women with ELAb', 'Women with Early Life Abuse', 'Medically healthy women (mean age=31) with or without a history of early (≤13 years) physical or sexual abuse provided self-report measures and were tested in the laboratory before and after randomization to standard MBSR (n=52) or']","['MBSR', 'Mindfulness-Based Stress Reduction', 'social support (SSG', 'Mindfulness-based stress reduction (MBSR']","['MBSR increased temporal summation of heat pain intensity ratings', 'temporal summation of heat pain intensity ratings', 'Experimental Pain Sensitivity and Cortisol Responses', 'Plasma cortisol', 'depression symptoms and emotion regulation abilities', 'cortisol-AUC', 'MBSR-specific improvements in central sensitization, mindfulness skills and emotion regulation abilities', 'cold pressor tolerance', 'pain sensitivity and cortisol-AUC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0030895', 'cui_str': 'Sodium Stibogluconate'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2938905', 'cui_str': 'Central Sensitization'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.037676,"Both MBSR and SSG improved depression symptoms and emotion regulation abilities (ps<0.001); however, MBSR was associated with greater benefits in describing emotions (p=.008) and impulse control (p=.017) for women with ELAb.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Andersen', 'Affiliation': 'Department of Psychiatry, University of North Carolina-Chapel Hill Department of Psychiatry, University of North Carolina-Chapel Hill Department of Psychiatry, University of North Carolina-Chapel Hill Department of Psychiatry, University of North Carolina-Chapel Hill Department of Psychiatry and Behavioral Sciences, Duke University Department of Biostatistics, University of North Carolina- Chapel Hill Department of Psychiatry, University of North Carolina-Chapel Hill Department of Psychiatry, University of North Carolina-Chapel Hill Department of Psychiatry, University of North Carolina-Chapel Hill Department of Physical Medicine and Rehabilitation, University of North Carolina-Chapel Hill Department of Psychiatry, University of North Carolina-Chapel Hill.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Geiger', 'Affiliation': ''}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Schiller', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Bluth', 'Affiliation': ''}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Watkins', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Hafsah', 'Initials': 'H', 'LastName': 'Tauseef', 'Affiliation': ''}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Leserman', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gaylord', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Girdler', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000889']
2268,33259326,Effects of online and recovery-oriented peer support groups facilitated by Peer Support Workers in times of COVID-19: Protocol for a feasibility study of a trial.,"BACKGROUND
In times of pandemics, social distancing, isolation and quarantine have precipitated depression, anxiety and substance misuse. Scientific literature suggests that patients living with mental health problems or illnesses (MHPIs) who interact with Peer Support Workers (PSWs) will not only feel the empathy and connectedness that comes from similar life experiences, but that this interaction also fosters hope in the possibility of a recovery. However, it is the effect of mental health teams or programs where there are PSWs that has been evaluated. Data will be collected for a future Randomized Controlled Trial by determining an effect size that would be specifically attributable to PSWs.
OBJECTIVE
The five principal research questions are whether this online intervention will have an impact in terms of (Q1) personal-civic recovery and (Q2) clinical recovery , (Q3) how these recovery potentials can be impacted by the COVID-19 pandemic, (Q4) how the lived experience of persons in recovery can be mobilized to cope with such a situation, and (Q5) how sex and gender considerations can be taken into account for the pairing of PSWs with service users, beyond considerations based solely on psychiatric diagnoses or specific MHPIs.
METHODS
Intervention: During the transitional and controlled online peer support groups, PSWs will simulate a typical unformal peer support group. They will have a personal-civic recovery focus, and they will be scripted with a fixed, predetermined duration (a series of 10 weekly 90-minute online workshops). There will be two experimental sub-groups: patients diagnosed with (1) psychotic disorders (n=10), and (2) anxiety or mood disorders (n=10), compared to a control group (n=10). Intervention Model: Parallel Assignment Allocation: Randomized Ratio: 2:1.
RESULTS
Measures: Several instruments have been developed by clinicians and academics to assess clinical recovery. Based on their life narratives and to assess personal-civic recovery, measurement tools have also been developed through community-based participatory research; for instance the Recovery Assessment Scale and the Citizenship Measure questionnaires (personal-civic recovery). This pre-post research feasibility study of a trial is proposed to evaluate the outcomes on personal-civic recovery (primary outcome); and to assess its effects in terms of clinical recovery and stress- or anxiety-related responses to the COVID-19 (secondary outcomes). The COVID Stress Scales and the measures of personal-civic recovery will be repeated, along with the following measures of clinical recovery: (i) Anxiety State-Trait Anxiety Inventory Form Y6, (ii) Depression Patient Health Questionnaire, (iii) Alcohol Use Disorders Identification Test, (iv) Drug Abuse Screening Test, (v) Psychosis Screening Questionnaire, and (vi) World Health Organization Disability Assessment Schedule. Change will be compared between groups from baseline to intervention vs. control group in the study outcome measures using the Student paired sample t test. Results are expected for December 2020.
CONCLUSIONS
Integrated Knowledge Translation: Study results will provide reliable evidence on a web-based intervention provided by Peer Support Workers. The investigators, with key decision makers and patient partners, will ensure knowledge translation throughout and the Massive Online Open Course (MOOC) on the Fundamentals of Recovery will be updated with the evidence and new knowledge generated by this feasibility study.
CLINICALTRIAL
ClinicalTrials.gov Identifier: NCT04445324.",2020,"Scientific literature suggests that patients living with mental health problems or illnesses (MHPIs) who interact with Peer Support Workers (PSWs) will not only feel the empathy and connectedness that comes from similar life experiences, but that this interaction also fosters hope in the possibility of a recovery.","['patients living with mental health problems or illnesses (MHPIs) who interact with Peer Support Workers (PSWs', 'patients diagnosed with (1) psychotic disorders (n=10), and (2) anxiety or mood disorders (n=10), compared to a control group (n=10', 'Intervention']","['Intervention Model', 'Integrated Knowledge Translation', 'online and recovery-oriented peer support groups facilitated by Peer Support Workers']","['personal-civic recovery', 'clinical recovery: (i) Anxiety State-Trait Anxiety Inventory Form Y6, (ii) Depression Patient Health Questionnaire, (iii) Alcohol Use Disorders Identification Test, (iv) Drug Abuse Screening Test, (v) Psychosis Screening Questionnaire, and (vi) World Health Organization Disability Assessment Schedule', 'COVID Stress Scales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1277251', 'cui_str': 'Has support worker'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C3494164', 'cui_str': 'Knowledge Translation'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C1277251', 'cui_str': 'Has support worker'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0038577', 'cui_str': 'Drug of abuse screen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0451124', 'cui_str': 'Disability assessment schedule'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.117625,"Scientific literature suggests that patients living with mental health problems or illnesses (MHPIs) who interact with Peer Support Workers (PSWs) will not only feel the empathy and connectedness that comes from similar life experiences, but that this interaction also fosters hope in the possibility of a recovery.","[{'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Pelletier', 'Affiliation': 'Department of Psychiatry and Addictology, University of Montreal, CR-IUSMM7401 Hochelaga Street, Montreal, CA.'}, {'ForeName': 'Janie', 'Initials': 'J', 'LastName': 'Houle', 'Affiliation': 'Department of Psychology, UQAM, Montreal, CA.'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Goulet', 'Affiliation': 'School of Nursing, University of Montreal, Montreal, CA.'}, {'ForeName': 'Robert-Paul', 'Initials': 'RP', 'LastName': 'Juster', 'Affiliation': 'Department of Psychiatry and Addictology, University of Montreal, CR-IUSMM7401 Hochelaga Street, Montreal, CA.'}, {'ForeName': 'Charles-Édouard', 'Initials': 'CÉ', 'LastName': 'Giguère', 'Affiliation': 'Montreal Mental Health University Institute - Research Centre, Montreal, CA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Bordet', 'Affiliation': 'Montreal Mental Health University Institute - Research Centre, Montreal, CA.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Hénault', 'Affiliation': 'Quebec Association of Peer Support Workers, Montreal, CA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lesage', 'Affiliation': 'Department of Psychiatry and Addictology, University of Montreal, CR-IUSMM7401 Hochelaga Street, Montreal, CA.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'De Benedictis', 'Affiliation': 'Montreal Mental Health University Institute - Research Centre, Montreal, CA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Denis', 'Affiliation': 'Université de Tours, Tours, FR.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ng', 'Affiliation': 'University of Hong Kong, Hong Kong, HK.'}]",JMIR research protocols,['10.2196/22500']
2269,33259257,More time in glucose range during exercise days than sedentary days in adults living with type 1 diabetes.,"OBJECTIVE
This study analysis was designed to examine the 24-hour effects of exercise on glycemic control as measured by continuous glucose monitoring (CGM).
METHODS
Individuals with type 1 diabetes (ages 15-68 years; HbA1c: 7.5±1.5% [mean±SD]) were randomly assigned to complete twice-weekly aerobic, high-intensity interval, or resistance-based exercise sessions in addition to their personal exercise sessions for a period of 4 weeks. Exercise was tracked with wearables and glucose concentrations assessed using CGM. An exercise day was defined as a 24-hour period after the end of exercise, while a sedentary day was defined as any 24-hour period with no recorded exercise ≥10 minutes long. Sedentary days start at least 24 hours after the end of exercise.
RESULTS
Mean glucose was lower (150±45 vs. 166±49 mg/dL, p=0.01), % time-in-range [70-180 mg/dL] higher (62±23 vs. 56±25%, p=0.03), % time >180 mg/dL lower (28±23% vs. 37±26%, p=0.01), and % time <70 mg/dL higher (9.3±10.9% vs. 7.1±9.1%, p=0.04) on exercise days compared with sedentary days. Glucose variability and % time <54 mg/dL did not differ significantly between exercise and sedentary days. No significant differences in glucose control by exercise type were observed.
CONCLUSION
Participants had lower 24-hour mean glucose levels and a greater TIR on exercise days compared with sedentary days, with mode of exercise affecting glycemia similarly. In summary, this study offers data supporting frequency of exercise as a method of facilitating glucose control but does not suggest an effect for mode of exercise.",2020,"Participants had lower 24-hour mean glucose levels and a greater TIR on exercise days compared with sedentary days, with mode of exercise affecting glycemia similarly.","['Individuals with type 1 diabetes (ages 15-68 years', 'adults living with type 1 diabetes']","['complete twice-weekly aerobic, high-intensity interval, or resistance-based exercise sessions in addition to their personal exercise sessions']","['Mean glucose', 'glucose control', '24-hour mean glucose levels', 'Glucose variability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",,0.0917372,"Participants had lower 24-hour mean glucose levels and a greater TIR on exercise days compared with sedentary days, with mode of exercise affecting glycemia similarly.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Riddell', 'Affiliation': 'York University, Kinesiology and Health Science, 4700 Keele Street, Toronto, Ontario, Canada, M3J1P3; mriddell@yorku.ca.'}, {'ForeName': 'Zoey', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Jaeb Centre for Health Research, 371336, Tampa, Florida, United States; zli@jaeb.org.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, Florida, United States, 33647; rbeck@jaeb.org.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Gal', 'Affiliation': 'Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, Florida, United States, 33647; rgal@jaeb.org.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Jacobs', 'Affiliation': 'Oregon Health & Science University, Department of Biomedical Engineering, 3303 SW Bond Ave, Portland, Oregon, United States, 97239; jacobsp@ohsu.edu.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Castle', 'Affiliation': 'Oregon Health & Science University, Medicine - Division of Endocrinology, L607, 3181 SW Sam Jackson Park Road, Portland, Oregon, United States, 97239; castleje@ohsu.edu.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Gillingham', 'Affiliation': 'Oregon Health & Science University, 6684, Molecular and Medical Genetics, 3181 SW Sam Jackson Park Road, Mailcode L103, Portland, Oregon, United States, 97239-3098; gillingm@ohsu.edu.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Clements', 'Affiliation': ""Children's Mercy Hospitals and Clinics, Pediatrics, Section of Endocrinology, 2401 Gillham Road, Kansas City, Missouri, United States, 64108; maclements@cmh.edu.""}, {'ForeName': 'Susana R', 'Initials': 'SR', 'LastName': 'Patton', 'Affiliation': ""Nemours Children's Health System, Nemours Children's Specialty Clinic, Jacksonville, Florida, United States; susana.patton@nemours.org.""}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Dassau', 'Affiliation': 'Harvard University, 29 Oxford St., Cambridge, Massachusetts, United States, 02138.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Doyle Iii', 'Affiliation': 'Harvard University, SEAS, 29 Oxford St, Harvard University, Cambridge, Massachusetts, United States, 02138.'}, {'ForeName': 'Corby', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, 14464, 6400 Perkins Road, Baton Rouge, Louisiana, United States, 70808; corby.martin@pbrc.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calhoun', 'Affiliation': 'Jaeb Centre for Health Research, 371336, 15310 Amberly Dr, #350, Tampa, Florida, United States, 33647-1642; pcalhoun@jaeb.org.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rickels', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, 14640, Philadelphia, Pennsylvania, United States; rickels@pennmedicine.upenn.edu.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0495']
2270,33259247,"A comparison of CrossFit and concurrent training on myonectin, insulin resistance and physical performance in healthy young women.","OBJECTIVE
To compare the effect of CrossFit and concurrent aerobic + resistance training (CT) on circulating myonectin levels, insulin resistance index, and physical performance in young women.
MATERIALS AND METHODS
Thirty healthy women were randomly assigned to CrossFit ( n = 16) and CT ( n = 14) groups, exercising three sessions per week for eight weeks. Serum myonectin levels, insulin resistance index, body composition, and performance variables were evaluated before and after the intervention period.
RESULTS
Neither the CrossFit nor the CT group improved in myonectin levels and insulin resistance index. While, fat percentage, muscle mass, upper-limb strength, VO 2max , HR at rest, lower body mean power output, and upper body peak power output improved more after CrossFit than the CT.
CONCLUSION
It seems that CrossFit exercises by targeting multiple fitness components in one exercise session may allow participants to perform more activity in less time.",2020,"Serum myonectin levels, insulin resistance index, body composition, and performance variables were evaluated before and after the intervention period.
","['young women', 'Thirty healthy women', 'healthy young women']","['CrossFit', 'CT', 'CrossFit exercises', 'CrossFit and concurrent aerobic\u2009+\u2009resistance training (CT', 'CrossFit and concurrent training']","['circulating myonectin levels, insulin resistance index, and physical performance', 'fat percentage, muscle mass, upper-limb strength, VO 2max , HR at rest, lower body mean power output, and upper body peak power output', 'Serum myonectin levels, insulin resistance index, body composition, and performance variables', 'myonectin levels and insulin resistance index', 'myonectin, insulin resistance and physical performance']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C1268087', 'cui_str': 'Upper body structure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",30.0,0.0190197,"Serum myonectin levels, insulin resistance index, body composition, and performance variables were evaluated before and after the intervention period.
","[{'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Bahremand', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Hakak Dokht', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Moazzami', 'Affiliation': 'Department of Exercise Physiology, Ferdowsi University of Mashhad, Mashhad, Iran.'}]",Archives of physiology and biochemistry,['10.1080/13813455.2020.1853173']
2271,33259244,Metronomic treatment of vinorelbine with oral capecitabine is tolerable in the randomized Phase 2 study XeNa including patients with HER2 non-amplified metastatic breast cancer.,"BACKGROUND
Metronomic treatment is hypothesized to be less toxic and more effective as compared to standard maximal tolerable dosing treatment in metastatic cancer disease.
MATERIAL AND METHODS
We tested the metronomic treatment principle with vinorelbine in a randomized phase 2 setting combined with standard capecitabine treatment in the XeNa trial with Clinical Trials.gov identifier number: NCT0141771. 120 patients with disseminated HER2 non-amplified breast cancer were included. Randomization was between Arm A: vinorelbine 60 mg/m 2 day 1 + day 8 in the first cycle followed by 80 mg/m 2 day 1 + day 8 in the following cycles or Arm B: vinorelbine 50 mg three times a week. Capecitabine 1000 mg/m 2 twice a day for days 1-14 was administered in both arms.
RESULTS
The treatment was generally well-tolerated. The response rate (RR) was 24% (arm A) versus 29% (arm B) ( p = .67). The clinical benefit rate (CBR) 46.8% (arm A) versus 51.7% (arm B) ( p = .72). We found a median progression-free survival (PFS) of 7.1 months (95% confidence interval [CI] 3.9-10.3) in arm A and 6.3 months (95% CI 4.1-8.5) in arm B ( p = .25) whereas median overall survival (OS) was 23.3 months (95% CI 20.2-26.4) in arm A and 22.3 months (95% CI 14.3-30.3) in arm B ( p = .76).
CONCLUSIONS
We confirmed that the combination of vinorelbine and capecitabine was well tolerated. Metronomic treatment can be used with acceptable adverse events (AEs), but we did not find significant difference in the effect compared to the standard treatment.",2020,The clinical benefit rate (CBR) 46.8% (arm A) versus 51.7% (arm B) ( p = .72).,"['metastatic cancer disease', '120 patients with disseminated HER2 non-amplified breast cancer', 'patients with HER2 non-amplified metastatic breast cancer']","['vinorelbine and capecitabine', 'vinorelbine with oral capecitabine', 'vinorelbine', 'standard capecitabine', 'Capecitabine 1000']","['tolerated', 'response rate (RR', 'median overall survival (OS', 'median progression-free survival (PFS']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",120.0,0.121848,The clinical benefit rate (CBR) 46.8% (arm A) versus 51.7% (arm B) ( p = .72).,"[{'ForeName': 'Anne Sofie', 'Initials': 'AS', 'LastName': 'Brems-Eskildsen', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Linnet', 'Affiliation': 'Department of Oncology, Region Hospital of West Jutland, Herning, Denmark.'}, {'ForeName': 'Hella', 'Initials': 'H', 'LastName': 'Danø', 'Affiliation': 'Department of Oncology, Region Hospital in Hilleroed, Hillerod, Denmark.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Luczak', 'Affiliation': 'Department of Oncology, University Hospital of Aalborg, Aalborg, Denmark.'}, {'ForeName': 'Peter Michael', 'Initials': 'PM', 'LastName': 'Vestlev', 'Affiliation': 'Department of Oncology, Roskilde Hospital, Roskilde, Denmark.'}, {'ForeName': 'Erik Hugger', 'Initials': 'EH', 'LastName': 'Jakobsen', 'Affiliation': 'Department of Oncology, Region Hospital in Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Jeppe', 'Initials': 'J', 'LastName': 'Neimann', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Charlotte Buch', 'Initials': 'CB', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Dongsgaard', 'Affiliation': 'Department of Oncology, Region Hospital of West Jutland, Herning, Denmark.'}, {'ForeName': 'Sven Tyge', 'Initials': 'ST', 'LastName': 'Langkjer', 'Affiliation': 'Department of Oncology, University Hospital of Aarhus, Aarhus, Denmark.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1851045']
2272,33259240,Comparison of intravesical instillation of hyaluronic acid with intradetrusor botulinum toxin A injection or cystoscopic hydrodistention for ketamine-associated cystitis.,"OBJECTIVE
This study aimed to compare the therapeutic effect of intravesical instillation hyaluronic acid with intradetrusor botulinum toxin A (BTX-A) injection or cystoscopic hydrodistention for ketamine-associated cystitis.
METHODS
Thirty-six patients were evenly randomly divided into the BTX-A group or the hydrodistention group. Patients received 200 U BTX-A detrusor injections in the BTX-A group and cystoscopic hydrodistention in the hydrodistention group. Intravesical instillation of hyaluronic acid was administrated in both groups for eight times. Patients with involuntary detrusor contraction were divided into the persistent involuntary detrusor contraction group and resolved involuntary detrusor contraction group after treatment in 6 months. The predictors of persistent involuntary detrusor contraction were analyzed.
RESULTS
Twelve months after treatment, the daytime frequency, Interstitial Cystitis Symptom Index, maximal capacity, and maximal cystometric capacity in the BTX-A group were significantly better than those in the hydrodistention group. Patients with resolution of involuntary detrusor contraction had a significantly shorter duration of ketamine, lower amount of fibrosis in pathology, and higher maximal capacity than those with persistent involuntary detrusor contraction 6 months after therapy.
CONCLUSION
Intravesical instillation of hyaluronic acid with intradetrusor BTX-A injection appears to be a preferable option for long-term effectiveness compared with cystoscopic hydrodistention.",2020,"Patients with resolution of involuntary detrusor contraction had a significantly shorter duration of ketamine, lower amount of fibrosis in pathology, and higher maximal capacity than those with persistent involuntary detrusor contraction 6 months after therapy.
","['Thirty-six patients', 'Patients with involuntary detrusor contraction']","['200 U BTX-A detrusor injections in the BTX-A group and cystoscopic hydrodistention', 'persistent involuntary detrusor contraction group and resolved involuntary detrusor contraction', 'hyaluronic acid with intradetrusor BTX-A injection', 'intravesical instillation hyaluronic acid with intradetrusor botulinum toxin A (BTX-A) injection', 'BTX-A group or the hydrodistention group', 'hyaluronic acid with intradetrusor botulinum toxin A injection', 'hyaluronic acid']","['duration of ketamine', 'daytime frequency, Interstitial Cystitis Symptom Index, maximal capacity, and maximal cystometric capacity']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021917', 'cui_str': 'Instillation of bladder'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}]",36.0,0.0161023,"Patients with resolution of involuntary detrusor contraction had a significantly shorter duration of ketamine, lower amount of fibrosis in pathology, and higher maximal capacity than those with persistent involuntary detrusor contraction 6 months after therapy.
","[{'ForeName': 'Bingkun', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qu', 'Initials': 'Q', 'LastName': 'Leng', 'Affiliation': 'Department of Urology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chuanyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Urology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Urology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Chaoming', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China.'}]",The Journal of international medical research,['10.1177/0300060520973100']
2273,33259163,Impact of Feeding Strategies With Acid Suppression on Esophageal Reflexes in Human Neonates With Gastroesophageal Reflux Disease: A Single-Blinded Randomized Clinical Trial.,"INTRODUCTION
Aims were to test hypothesis that esophageal provocation-induced reflexes are superior with acid suppression plus feeding modifications vs acid suppression alone among infants treated for gastroesophageal reflux disease (GERD).
METHODS
Infants (N = 49, 41.3 ± 2.6 of postmenstrual age) with acid reflux index >3% underwent longitudinal motility testing (weeks 0 and 5) with graded midesophageal provocation to test randomly allocated therapies (4 weeks' proton pump inhibitor [PPI] ± feeding modifications) on sensory-motor aerodigestive reflexes. Feeding modification included restricted fluid volume <140 mL/kg per day, fed over 30 minutes in right lateral position and supine postprandial position. Primary motility outcome was frequency-occurrence of peristaltic reflex. Secondary outcomes included upper esophageal sphincter contractile reflex, lower esophageal sphincter (LES) relaxation reflex, respiratory change, and symptom characteristics.
RESULTS
Treatment groups did not differ for primary outcome (odds ratio = 0.8, 95% confidence interval 0.4-1.6, P = 0.99) or secondary outcomes (all P > 0.05). For both treatment groups at follow-up, distal esophageal contraction and LES tone decreased, and LES relaxation reflex occurrence is less frequent (all P < 0.05). In a subgroup analysis, comparing infants with PPI washout (N = 40) vs with continued (N = 9) PPI therapy, no differences were noted for aerodigestive reflex response frequency-occurrence (all P > 0.05).
DISCUSSION
In infants with GERD, feeding modification with acid suppression is not superior to acid suppression alone in modifying aerodigestive reflexes (frequency, sensation, or magnitude). Contiguous areas targeted by GER, i.e., LES and distal esophageal functions, worsened at follow-up for both groups despite PPI therapy. Maturation is likely the key factor for GERD resolution in infants, justifying the use of placebo in clinical trials for objectively determined GERD.",2020,"RESULTS
Treatment groups did not differ for primary outcome (odds ratio = 0.8, 95% confidence interval 0.4-1.6, P = 0.99) or secondary outcomes (all P > 0.05).","['infants treated for gastroesophageal reflux disease (GERD', 'Human Neonates', 'With Gastroesophageal Reflux Disease', 'Infants (N = 49, 41.3 ± 2.6 of postmenstrual age) with acid reflux index >3% underwent']","[""longitudinal motility testing (weeks 0 and 5) with graded midesophageal provocation to test randomly allocated therapies (4 weeks' proton pump inhibitor [PPI] ± feeding modifications"", 'Feeding Strategies With Acid Suppression', 'placebo', 'acid suppression plus feeding modifications vs acid suppression alone']","['Esophageal Reflexes', 'distal esophageal contraction and LES tone', 'frequency-occurrence of peristaltic reflex', 'upper esophageal sphincter contractile reflex, lower esophageal sphincter (LES) relaxation reflex, respiratory change, and symptom characteristics', 'aerodigestive reflex response frequency-occurrence', 'LES relaxation reflex occurrence']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C4517770', 'cui_str': '41.3'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0201074', 'cui_str': 'Motility test'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014865', 'cui_str': 'Esophageal sphincter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1451819', 'cui_str': 'Upper Esophageal Sphincter'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0683952,"RESULTS
Treatment groups did not differ for primary outcome (odds ratio = 0.8, 95% confidence interval 0.4-1.6, P = 0.99) or secondary outcomes (all P > 0.05).","[{'ForeName': 'Sudarshan R', 'Initials': 'SR', 'LastName': 'Jadcherla', 'Affiliation': ""1Innovative Infant Feeding Disorders Research Program, Nationwide Children's Hospital, Columbus, Ohio, USA; 2Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA; 3Division of Neonatology, Nationwide Children's Hospital Columbus, Ohio, USA; 4Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Department of Pediatrics, The Ohio State University College of Medicine, Columbus, Ohio, USA; 5Biostatistics Resource at Nationwide Children's Hospital (BRANCH), Columbus, Ohio, USA; 6Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University College of Medicine, Columbus, Ohio, USA.""}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Hasenstab', 'Affiliation': ''}, {'ForeName': 'Ish K', 'Initials': 'IK', 'LastName': 'Gulati', 'Affiliation': ''}, {'ForeName': 'Roseanna', 'Initials': 'R', 'LastName': 'Helmick', 'Affiliation': ''}, {'ForeName': 'Haluk', 'Initials': 'H', 'LastName': 'Ipek', 'Affiliation': ''}, {'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Yildiz', 'Affiliation': ''}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ''}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000249']
2274,33263957,[Early detection of prostate cancer: a summary of the past 10 years].,"Early detection of prostate cancer remains a controversial subject for the general practitioner. In fact, prostate cancer remains the most frequently diagnosed non skin tumor in men with a proportion of 15 %. However, while prostate specific antigen has massively contributed to its identification at a curable stage for 25 years, it has simultaneously appeared essential not to overtreat a cancer with a significant proportion of indolent tumors. In parallel with this controversial background, the prospective randomized study of the European Randomized Study of Screening for Prostate Cancer, and in particular its Swedish subpopulation, has validated during the last decade the benefit of at least early detection. However, due to the variety of treatment options and the potential side effects of some of them, it is recommended that this detection be performed only in properly informed patients.",2020,"However, while prostate specific antigen has massively contributed to its identification at a curable stage for 25 years, it has simultaneously appeared essential not to overtreat a cancer with a significant proportion of indolent tumors.",['prostate cancer'],[],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0188127,"However, while prostate specific antigen has massively contributed to its identification at a curable stage for 25 years, it has simultaneously appeared essential not to overtreat a cancer with a significant proportion of indolent tumors.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vaccaro', 'Affiliation': ""Service d'urologie, HUG, 1211 Genève 14.""}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Roosendaal', 'Affiliation': ""Service d'urologie, HUG, 1211 Genève 14.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Iselin', 'Affiliation': ""Service d'urologie, HUG, 1211 Genève 14.""}]",Revue medicale suisse,[]
2275,33263819,"Effects of nasal high flow on nocturnal hypercapnia, sleep, and sympathovagal balance in patients with neuromuscular disorders.","PURPOSE
In neuromuscular disorders (NMD), inspiratory muscle weakness may cause sleep-related hypoventilation requiring non-invasive ventilation (NIV). Alternatively, nasal high flow therapy (NHF) may ameliorate mild nocturnal hypercapnia (NH) through washout of anatomical dead space and generation of positive airway pressure. Ventilatory support by NIV or NHF might have favourable short-term effects on sympathovagal balance (SVB). This study comparatively investigated the effects of NHF and NIV on sleep-related breathing and SVB in NMD patients with evolving NH.
METHODS
Transcutaneous CO 2 (p tc CO 2 ), peripheral oxygen saturation (SpO 2 ), sleep outcomes and SVB (spectral analysis of heart rate, diastolic blood pressure variability) along with haemodynamic measures (cardiac index, total peripheral resistance index) were evaluated overnight in 17 patients. Polysomnographies (PSG) were randomly split into equal parts with no treatment, NIV and NHF at different flow rates (20 l/min vs. 50 l/min). In-depth analysis of SVB and haemodynamics was performed on 10-min segments of stable N2 sleep taken from each intervention.
RESULTS
Compared with no treatment, NHF20 and NHF50 did not significantly change p tc CO 2 , SpO 2 or the apnea hypopnea index (AHI). NHF50 was poorly tolerated. In contrast, NIV significantly improved both gas exchange and AHI without adversely affecting sleep. During daytime, NHF20 and NHF50 had neutral effects on ventilation and oxygenation whereas NIV improved p tc CO 2 and SpO 2 . Effects of NIV and NHF on SVB and haemodynamics were neutral during both night and daytime.
CONCLUSIONS
NHF does not correct sleep-disordered breathing in NMD patients with NH. Both NHF and NIV exert no immediate effects on SVB.",2020,"Compared with no treatment, NHF20 and NHF50 did not significantly change p tc CO 2 , SpO 2 or the apnea hypopnea index (AHI).","['NMD patients with evolving NH', 'patients with neuromuscular disorders', 'NMD patients with NH']","['NHF', 'nasal high flow therapy (NHF', 'NHF and NIV', 'NIV and NHF', 'NHF50', 'nasal high flow', 'Polysomnographies (PSG) were randomly split into equal parts with no treatment, NIV and NHF']","['NHF20 and NHF50', 'sympathovagal balance (SVB', 'peripheral oxygen saturation (SpO 2 ), sleep outcomes and SVB (spectral analysis of heart rate, diastolic blood pressure variability) along with haemodynamic measures (cardiac index, total peripheral resistance index', 'gas exchange and AHI without adversely affecting sleep', 'ventilation and oxygenation', 'SVB and haemodynamics', 'correct sleep-disordered breathing', 'nocturnal hypercapnia, sleep, and sympathovagal balance', 'mild nocturnal hypercapnia (NH', 'change p tc CO 2 , SpO 2 or the apnea hypopnea index (AHI', 'sleep-related breathing and SVB']","[{'cui': 'C0027868', 'cui_str': 'Myoneural disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0161696,"Compared with no treatment, NHF20 and NHF50 did not significantly change p tc CO 2 , SpO 2 or the apnea hypopnea index (AHI).","[{'ForeName': 'Anna Christina', 'Initials': 'AC', 'LastName': 'Meyer', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, Münster University Hospital, Munster, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Spiesshoefer', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, Münster University Hospital, Munster, Germany.'}, {'ForeName': 'Nina Christina', 'Initials': 'NC', 'LastName': 'Siebers', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, Münster University Hospital, Munster, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heidbreder', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, Münster University Hospital, Munster, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiedemann', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, Münster University Hospital, Munster, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schneider', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care, Department of Medicine, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Braun', 'Affiliation': 'Sleep Disorders Center, Bayview Hospital, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Randerath', 'Affiliation': 'Bethanien Hospital gGmbH Solingen, Solingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Park Klinik Reithofpark, Bad Feilnbach, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dreher', 'Affiliation': 'Department of Pneumology and Intensive Care Medicine, University Hospital RWTH, Aachen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Boentert', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, Münster University Hospital, Munster, Germany. matthias.boentert@ukmuenster.de.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02263-2']
2276,33263788,Post-weight loss changes in fasting appetite- and energy balance-related hormone concentrations and the effect of the macronutrient content of a weight maintenance diet: a randomised controlled trial.,"PURPOSE
We investigated the effects of the macronutrient composition of diets with differing satiety values on fasting appetite-related hormone concentrations after weight loss and examined whether the hormone secretion adapted to changes in body fat mass (FM) and fat-free mass (FFM) during the weight maintenance period (WM).
METHODS
Eighty-two men and women with obesity underwent a 7-week very-low-energy diet (VLED) and were then randomised to a higher-satiety food (HSF) group or a lower-satiety food (LSF) group during 24-weeks of the WM. The groups consumed isoenergetic foods with different satiety ratings and macronutrient compositions.
RESULTS
During the WM, the HSF group consumed more protein and dietary fibre and less fat than the LSF group, but the groups showed similar changes in body weight and fasting appetite-related hormones. In the whole study sample, VLED induced 12 kg (p < 0.001) weight loss. At the end of the WM, weight regain was 1.3 kg (p = 0.004), ghrelin concentration increased, whereas leptin, insulin, and glucose concentrations decreased compared to pre-VLED levels (p < 0.001 for all). Peptide YY did not differ from pre-VLED levels. Changes in ghrelin levels were inversely associated with changes in FFM during weeks 0-12 of the WM (p = 0.002), while changes in leptin and insulin levels were positively associated with changes in FM during weeks 0-12 (p = 0.015 and p = 0.038, respectively) and weeks 12-24 (p < 0.001 and p = 0.022) of the WM.
CONCLUSIONS
The macronutrient composition of an isoenergetic WM diet did not affect fasting appetite-related hormone concentrations. Leptin and insulin adjusted to the reduced FM, whereas ghrelin reflected FFM during the first months of the WM.
TRIAL REGISTRATION
isrctn.com, ID 67529475.",2020,"At the end of the WM, weight regain was 1.3 kg (p = 0.004), ghrelin concentration increased, whereas leptin, insulin, and glucose concentrations decreased compared to pre-VLED levels (p < 0.001 for all).",['Eighty-two men and women with obesity underwent a'],"['LSF', '7-week very-low-energy diet (VLED', 'macronutrient composition of diets with differing satiety values', 'higher-satiety food (HSF) group or a lower-satiety food (LSF']","['weight loss', 'body fat mass (FM) and fat-free mass (FFM', 'weight regain', 'ghrelin concentration', 'body weight and fasting appetite-related hormones', 'fasting appetite-related hormone concentrations', 'Leptin and insulin adjusted to the reduced FM', 'leptin and insulin levels', 'ghrelin levels', 'protein and dietary fibre and less fat', 'FFM', 'leptin, insulin, and glucose concentrations']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452268', 'cui_str': 'Very low energy diet'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}]",82.0,0.0482577,"At the end of the WM, weight regain was 1.3 kg (p = 0.004), ghrelin concentration increased, whereas leptin, insulin, and glucose concentrations decreased compared to pre-VLED levels (p < 0.001 for all).","[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Näätänen', 'Affiliation': 'Department of Clinical Nutrition, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, 70211, Kuopio, Finland.'}, {'ForeName': 'Marjukka', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'Department of Clinical Nutrition, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, 70211, Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Physiology, Institute of Biomedicine, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Herzig', 'Affiliation': 'Institute of Biomedicine, Medical Research Center (MRC), University of Oulu, University Hospital, Oulu, Finland.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Poutanen', 'Affiliation': 'VTT Technical Research Centre of Finland, Espoo, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Karhunen', 'Affiliation': 'Department of Clinical Nutrition, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, P.O. Box 1627, 70211, Kuopio, Finland. leila.karhunen@uef.fi.'}]",European journal of nutrition,['10.1007/s00394-020-02438-3']
2277,33263750,"Erratum to: Sodium Zirconium Cyclosilicate Increases Serum Bicarbonate Concentrations Among Patients with Hyperkalaemia: Exploratory Analyses from Three Randomized, Multi-Dose, Placebo-Controlled Trials.",,2020,,['Patients with Hyperkalaemia'],"['Placebo', 'Sodium Zirconium Cyclosilicate']",['Serum Bicarbonate Concentrations'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.076138,,[],"Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa305']
2278,33263718,Randomized Trial Replication Using Observational Data for Comparative Effectiveness of Secukinumab and Ustekinumab in Psoriasis: A Study From the British Association of Dermatologists Biologics and Immunomodulators Register.,"Importance
Treatments for psoriasis may be less effective in everyday practice than in clinical trials. Emulating a target trial using data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) can provide treatment effect estimates that are robust and can inform both clinicians and regulatory bodies.
Objectives
To assess the comparative effectiveness of ustekinumab and secukinumab in patients with psoriasis, and to test whether the relative effectiveness estimate of the CLEAR trial, a randomized clinical trial that compared secukinumab with ustekinumab for psoriasis, can be replicated.
Design, Setting, and Participants
This comparative effectiveness research study used a target trial emulation approach and was performed between November 2007 and August 2019. Data were obtained from BADBIR, a multicenter longitudinal pharmacovigilance register of patients with moderate to severe psoriasis in the United Kingdom and Republic of Ireland. Participants had chronic plaque psoriasis, were 18 years or older, and had at least 1 record of a Psoriasis Area and Severity Index (PASI) of 12 or higher before their initiation to secukinumab or ustekinumab. Propensity score (PS) 1:1 matched analysis and inverse probability treatment weighted analysis were performed.
Main Outcomes and Measures
The primary outcomes were the risk ratio (RR) and the risk difference (RD) for achieving PASI of 2 or lower after 12 months of therapy for secukinumab compared with ustekinumab. Methods to account for missing outcome data were complete case analysis, nonresponder imputation, last observation carried forward, inverse probability of censoring weighting, and multiple imputation. Regulatory and estimate agreement metrics were used to benchmark the effect estimates in this study against those in the CLEAR trial.
Results
A total of 1231 patients were included in the analysis, with 917 receiving ustekinumab and 314 receiving secukinumab. Secukinumab was superior to ustekinumab in all analyses, except under the nonresponder imputation method, in the proportion of participants achieving a PASI of 2 or lower (PS-weighted complete case analysis: RR, 1.28 [95% CI, 1.06-1.55]; RD, 11.9% [1.6-22.1]). All analyses, except for nonresponder imputation, reached regulatory agreement in both PS-matching and PS-weighted analyses.
Conclusions and Relevance
This comparative effectiveness study found that secukinumab resulted in more patients achieving a PASI of 2 or lower after 12 months of therapy compared with ustekinumab in patients with psoriasis. Target trial emulation in this study resulted in regulatory and estimate agreement with the CLEAR randomized clinical trial; further such studies may help fill the evidence gap when comparing other systemic therapies for psoriasis.",2020,"Secukinumab was superior to ustekinumab in all analyses, except under the nonresponder imputation method, in the proportion of participants achieving a PASI of 2 or lower (PS-weighted complete case analysis: RR, 1.28 [95% CI, 1.06-1.55]; RD, 11.9% [1.6-22.1]).","['A total of 1231 patients were included in the analysis, with 917 receiving ustekinumab and 314 receiving secukinumab', 'patients with psoriasis', 'November 2007 and August 2019', 'Participants had chronic plaque psoriasis, were 18 years or older, and had at least 1 record of a Psoriasis Area and Severity Index (PASI) of 12 or higher before their initiation to secukinumab or ustekinumab', 'patients with moderate to severe psoriasis in the United Kingdom and Republic of Ireland', 'Psoriasis']","['ustekinumab and secukinumab', 'secukinumab', 'Secukinumab and Ustekinumab']","['Propensity score (PS', 'risk ratio (RR) and the risk difference (RD) for achieving PASI of 2 or lower']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C5191378', 'cui_str': '917'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",1231.0,0.27092,"Secukinumab was superior to ustekinumab in all analyses, except under the nonresponder imputation method, in the proportion of participants achieving a PASI of 2 or lower (PS-weighted complete case analysis: RR, 1.28 [95% CI, 1.06-1.55]; RD, 11.9% [1.6-22.1]).","[{'ForeName': 'Zenas Z N', 'Initials': 'ZZN', 'LastName': 'Yiu', 'Affiliation': 'Centre for Dermatology Research, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester, United Kingdom.'}, {'ForeName': 'Kayleigh J', 'Initials': 'KJ', 'LastName': 'Mason', 'Affiliation': 'Centre for Dermatology Research, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Hampton', 'Affiliation': 'Institute of Translational and Clinical Medicine, Newcastle University Medical School, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Nick J', 'Initials': 'NJ', 'LastName': 'Reynolds', 'Affiliation': 'Institute of Translational and Clinical Medicine, Newcastle University Medical School, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Catherine H', 'Initials': 'CH', 'LastName': 'Smith', 'Affiliation': ""St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lunt', 'Affiliation': 'Versus Arthritis Centre for Epidemiology, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Christopher E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dermatology Research, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester, United Kingdom.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Centre for Dermatology Research, Salford Royal NHS Foundation Trust, The University of Manchester, Manchester Academic Health Science Centre, National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA dermatology,['10.1001/jamadermatol.2020.4202']
2279,33244838,Effectiveness and safety of lidocaine patch 5% to treat herpes zoster acute neuralgia and to prevent postherpetic neuralgia.,"Herpes zoster is often associated to acute neuralgia and postherpetic neuralgia (PHN). Their therapeutic management is still challenging: among therapeutic options, lidocaine patch 5% was rarely used in acute neuralgia on lesional skin, and its efficacy to prevent PHN was never studied. The efficacy and tolerability of lidocaine patch 5% was evaluated in 38 patients with acute neuralgia (19) and PHN (19). Pain intensity was investigated using DN4 questionnaire and NRS-11 scale at baseline and at week 2, 4, and 8. The use of rescue therapy was also evaluated. A significant reduction of DN4 and NRS-11 was observed already at W2, with further improvement at W4 and W8. A complete response to treatment (DN4 and NRS-11 = 0) at week 8 was higher in patients with acute neuralgia (63.2%) than PHN (31.6%). Rescue therapy gradually decreased in acute neuralgia patients from week 2 (57.9%) to week 8 (10.5%), with only two patients needing neuroleptics. In PHN patients rescue therapy remained stable (68.4%). According to our results, lidocaine patch 5% applied on lesional skin was well tolerated and ensured a rapid pain relief in acute neuralgia; if early used, it prevented PHN in almost all patients.",2020,"According to our results, lidocaine patch 5% applied on lesional skin was well tolerated and ensured a rapid pain relief in acute neuralgia; if early used, it prevented PHN in almost all patients.","['herpes zoster acute neuralgia and to prevent postherpetic neuralgia', '38 patients with acute neuralgia (19) and PHN (19']","['lidocaine patch', 'lidocaine']","['DN4 and NRS-11', 'efficacy and tolerability', 'Effectiveness and safety', 'DN4 questionnaire and NRS-11 scale', 'Pain intensity']","[{'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0032768', 'cui_str': 'Postherpetic neuralgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",38.0,0.0136419,"According to our results, lidocaine patch 5% applied on lesional skin was well tolerated and ensured a rapid pain relief in acute neuralgia; if early used, it prevented PHN in almost all patients.","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bianchi', 'Affiliation': 'Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Piergiovanni', 'Affiliation': 'Anesthesia Section, Santa Maria della Misericordia Hospital, Perugia, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Marietti', 'Affiliation': 'Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Renzini', 'Affiliation': 'Anesthesia Section, Santa Maria della Misericordia Hospital, Perugia, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Gori', 'Affiliation': 'Anesthesia Section, Santa Maria della Misericordia Hospital, Perugia, Italy.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hansel', 'Affiliation': 'Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Tramontana', 'Affiliation': 'Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Stingeni', 'Affiliation': 'Dermatology Section, Department of Medicine, University of Perugia, Perugia, Italy.'}]",Dermatologic therapy,['10.1111/dth.14590']
2280,33268629,"[The effect of whole body vibration by sonic waves on mood, the autonomic nervous system, and brain function in elderly].","AIM
The purpose of this study was to clarify the effect of sonic wave vibration (SWV) on mood, the autonomic-nervous system, brain function and cognitive function in elderly people.
METHODS
We randomly assigned 24 late-stage elderly people (M 88.0±5.0 yrs) into a SWV group and a control group. The SWV group conducted 10 minutes of SWV per day, 5 days a week for 8 consecutive weeks. For evaluation purposes, we analyzed the moods with TDMS, heart rate variability (HRV), resting energy expenditure (REE), and brain activation during the Stroop test using near-infrared spectroscopy (NIRS).
RESULTS
The stability level and pleasure level of mood increased significantly immediately after SWV. Simultaneously, the levels of the parasympathetic nervous system index of HRV significantly increased while the levels of the sympathetic nervous system index significantly decreased. REE also significantly increased. These results suggest that SWV has a relaxation effect as well as increasing the energy expenditure for elderly people. After intervention, Stroop B's execution time significantly decreased suggesting an improvement in the processing speed. The NIRS revealed that SWV may therefore activate the frontal lobe function.
CONCLUSIONS
These results suggest that SWV may have a positive effect on mood, the autonomic nervous system, cognitive function and brain functions, and thus such treatment may be useful for elderly people.",2020,"Simultaneously, the levels of the parasympathetic nervous system index of HRV significantly increased while the levels of the sympathetic nervous system index significantly decreased.","['24 late-stage elderly people (M 88.0±5.0 yrs) into a SWV group and a control group', 'elderly people', 'elderly']","['SWV', 'whole body vibration by sonic waves', 'sonic wave vibration (SWV']","['moods with TDMS, heart rate variability (HRV), resting energy expenditure (REE), and brain activation during the Stroop test using near-infrared spectroscopy (NIRS', 'stability level and pleasure level of mood', 'levels of the parasympathetic nervous system index of HRV', 'sympathetic nervous system index', 'REE', ""Stroop B's execution time""]","[{'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0424113', 'cui_str': 'Level of mood'}, {'cui': 'C0030510', 'cui_str': 'Parasympathetic nervous system structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",24.0,0.0196626,"Simultaneously, the levels of the parasympathetic nervous system index of HRV significantly increased while the levels of the sympathetic nervous system index significantly decreased.","[{'ForeName': 'Wonchul', 'Initials': 'W', 'LastName': 'Choi', 'Affiliation': 'Japan Home Health Coach Association.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Mizukami', 'Affiliation': 'Graduate School of Comprehensive Human Science, Department of Social Health and Stress Management, University of Tsukuba.'}]",Nihon Ronen Igakkai zasshi. Japanese journal of geriatrics,['10.3143/geriatrics.57.441']
2281,33268603,Long-Term Clinical Outcomes After Filter Protection During Percutaneous Coronary Intervention in Patients With Attenuated Plaque - 1-Year Follow up of the VAMPIRE 3 (Vacuum Aspiration Thrombus Reemoval 3) Trial.,"BACKGROUND
Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 [11.2%] vs. 2 [2.1%], P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32).
CONCLUSIONS
In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.",2020,"In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group.",['Patients who had ACS with attenuated plaque ≥5 mm'],"['conventional PCI', 'distal protection (DP) (n=98) or conventional treatment (CT', 'MACE', 'percutaneous coronary intervention (PCI', 'bare-metal stents']","['rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR', '1-year rates of MACE', 'rates of MACE', 'risk of TVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0569199,"In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group.","[{'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Division of Cardiology, Teikyo University School of Medicine.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Maejima', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center.'}, {'ForeName': 'Shinjo', 'Initials': 'S', 'LastName': 'Sonoda', 'Affiliation': 'Second Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Endo', 'Affiliation': 'Division of Cardiology, Saiseikai Yokohamashi Nanbu Hospital.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiology, Tokyo Metropolitan Tama Medical Center.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kyono', 'Affiliation': 'Division of Cardiology, Teikyo University School of Medicine.'}, {'ForeName': 'Ryoji', 'Initials': 'R', 'LastName': 'Koshida', 'Affiliation': 'Tokeidai Memorial Hospital Cardiovascular Center.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ishihara', 'Affiliation': 'Kansai Rosai Hospital Cardiovascular Center.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Awata', 'Affiliation': 'Cardiovascular Division, Mombetsu General Hospital.'}, {'ForeName': 'Teruyoshi', 'Initials': 'T', 'LastName': 'Kume', 'Affiliation': 'Department of Cardiology, Kawasaki Medical School.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tanabe', 'Affiliation': 'Division of Cardiology, Mitsui Memorial Hospital.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University School of Medicine.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Tsukahara', 'Affiliation': 'Division of Cardiology, Fujisawa City Hospital.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ikari', 'Affiliation': 'Department of Cardiology, Tokai University.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Department of Cardiology, Sakurabashi Watanabe Hospital.'}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Cardiology, NTT Medical Center Tokyo.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Sumiyoshi', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Yoshino', 'Affiliation': 'Department of Cardiology, Kyorin University Graduate School of Medicine, Division of Cardiology.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Isshiki', 'Affiliation': 'Ageo Central General Hospital.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0449']
2282,33268583,Risk prediction for postpartum depression based on random forest.,"OBJECTIVES
To explore the application of random forest algorithm in screening the risk factors and predictive values for postpartum depression.
METHODS
We recruited the participants from a tertiary hospital between June 2017 and June 2018 in Changsha City, and followed up from pregnancy up to 4-6 weeks postpartum.Demographic economics, psychosocial, biological, obstetric, and other factors were assessed at first trimesters with self-designed obstetric information questionnaire and the Chinese version of Edinburgh Postnatal Depression Scale (EPDS). During 4-6 weeks after delivery, the Chinese version of EPDS was used to score depression and self-designed questionnaire to collect data of delivery and postpartum. The data of subjects were randomly divided into the training data set and the verification data set according to the ratio of 3꞉1. The training data set was used to establish the random forest model of postpartum depression, and the verification data set was used to verify the predictive effects via the accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and AUC index.
RESULTS
A total of 406 participants were in final analysis. Among them, 150 of whom had EPDS score ≥9, and the incidence of postpartum depression was 36.9%. The predictive effects of random forest model in the verification data set were at accuracy of 80.10%, sensitivity of 61.40%, specificity of 89.10%, positive predictive value of 73.00%, negative predictive value of 82.80%, and AUC index of 0.833. The top 10 predictive influential factors that screening by the variable importance measure in random forest model was antenatal depression, economic worries after delivery, work worries after delivery, free triiodothyronine in first trimesters, high-density lipoprotein in third trimester, venting temper to infants, total serum cholesterol and serum triglyceride in first trimester, hematocrit and serum triglyceride in third trimester.
CONCLUSIONS
Random forest has a great advantage in risk prediction for postpartum depression. Through comprehensive evaluation mechanism, it can identify the important influential factors for postpartum depression from complex multi-factors and conduct quantitative analysis, which is of great significance to identify the key factors for postpartum depression and carry out timely and effective intervention.",2020,"The predictive effects of random forest model in the verification data set were at accuracy of 80.10%, sensitivity of 61.40%, specificity of 89.10%, positive predictive value of 73.00%, negative predictive value of 82.80%, and AUC index of 0.833.","['406 participants were in final analysis', 'participants from a tertiary hospital between June 2017 and June 2018 in Changsha City, and followed up from pregnancy up to 4-6 weeks postpartum']",[],"['antenatal depression, economic worries after delivery, work worries after delivery, free triiodothyronine in first trimesters, high-density lipoprotein in third trimester, venting temper to infants, total serum cholesterol and serum triglyceride in first trimester, hematocrit and serum triglyceride', 'Demographic economics, psychosocial, biological, obstetric, and other factors', 'accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and AUC index', 'Chinese version of Edinburgh Postnatal Depression Scale (EPDS', 'incidence of postpartum depression']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",[],"[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0578855', 'cui_str': 'Work worries'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1445957', 'cui_str': 'Serum total cholesterol measurement'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",406.0,0.053762,"The predictive effects of random forest model in the verification data set were at accuracy of 80.10%, sensitivity of 61.40%, specificity of 89.10%, positive predictive value of 73.00%, negative predictive value of 82.80%, and AUC index of 0.833.","[{'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Xiangya Nursing School, Central South University, Changsha 410013. 786001878@qq.com.'}, {'ForeName': 'Chunli', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Oncology, Third Xiangya Hospital, Central South University, Changsha 410013.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Third Xiangya Hospital, Central South University, Changsha 410013.'}, {'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'School of Mathematics and Statistics, Central South University, Changsha 410013.'}, {'ForeName': 'Shujuan', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Third Xiangya Hospital, Central South University, Changsha 410013.'}, {'ForeName': 'Dongqi', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Xiangya Nursing School, Central South University, Changsha 410013.'}, {'ForeName': 'Beimei', 'Initials': 'B', 'LastName': 'Lei', 'Affiliation': 'Xiangya Nursing School, Central South University, Changsha 410013.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': 'Xiangya Nursing School, Central South University, Changsha 410013.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Xiangya Nursing School, Central South University, Changsha 410013. leijunbao@126.com.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.190655']
2283,33268580,Clinical efficacy of Danhong injection in preventing contrast-induced acute kidney injury based on propensity score matching method.,"OBJECTIVES
Contrast-induced acute kidney injury (CI-AKI) is the third cause of hospital-acquired AKI, and existing clinical prevention and treatment measures such as hydration therapy and/or administration of antioxidants N-acetylcysteine treatment and other treatments still show little effect on the prevention and treatment of CI-AKI. This study aims to explore the effect of Danhong injection on prevention of CI-AKI.
METHODS
A total of 12 867 patients, who received coronary angiography, percutaneous coronary intervention, enhanced CT or vascular intervention in a tertiary hospital, were enrolled for this study. Among them, 423 in the treatment group received intravenous drip of Danhong injection, and 12 444 in the control group received routine medicine. Propensity score matching was conducted to balance confounding factors between the 2 groups and then the prevention effect of Danhong injection on CI-AKI was compared between them.
RESULTS
A total of 423 pairs of patients were matched successfully. The incidence of CI-AKI in the non-Danhong control group was higher than that in the Danhong treatment group (5.7% vs 2.4%). The difference between the 2 groups was statistically significant ( P <0.05). CI-AKI occurred maily in the Stage 1 in both the non-Danhong control group and the Danhong treatment group. The number of patients with Stage 1 of AKI in the control group was more than that in the treatment group, and the difference was statistically significant ( P <0.05). The incidence of AKI in Stage 2 and Stage 3 was less in both groups, and the difference was not statistically significant ( P >0.05).
CONCLUSIONS
The results of this study support the use of Danhong injection in the prevention of the Stage 1 of CI-AKI.",2020,"The incidence of AKI in Stage 2 and Stage 3 was less in both groups, and the difference was not statistically significant ( P >0.05).
","['A total of 423 pairs of patients were matched successfully', 'A total of 12 867 patients, who received coronary angiography, percutaneous coronary intervention, enhanced CT or vascular intervention in a tertiary hospital, were enrolled for this study']","['intravenous drip of Danhong injection', 'routine medicine', 'Danhong injection']","['number of patients with Stage 1 of AKI', 'incidence of AKI', 'CI-AKI', 'incidence of CI-AKI']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C2715773', 'cui_str': 'danhong'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",12867.0,0.0644946,"The incidence of AKI in Stage 2 and Stage 3 was less in both groups, and the difference was not statistically significant ( P >0.05).
","[{'ForeName': 'Jianglin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pharmacy, Third Xiangya Hospital, Central South University, Changsha 410013. jianglin_wang@163.com.'}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Pharmacy, Third Xiangya Hospital, Central South University, Changsha 410013.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'Department of Pharmacy, Third Xiangya Hospital, Central South University, Changsha 410013.'}, {'ForeName': 'Daiyang', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Third Xiangya Hospital, Central South University, Changsha 410013.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Third Xiangya Hospital, Central South University, Changsha 410013.'}, {'ForeName': 'Xiaocong', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Pharmacy, Third Xiangya Hospital, Central South University, Changsha 410013. zuoxc08@126.com.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.190191']
2284,33268579,Effect of resistance exercise on peripheral neuropathy in Type 2 diabetes mellitus.,"OBJECTIVES
To explore the improvement of neurological symptoms in patients with Type 2 diabetic peripheral neuropathy via resistance exercise.
METHODS
A total of 100 patients with Type 2 diabetic peripheral neuropathy were selected as the research objects, and they were randomly divided into an observation group who performed resistance exercise ( n =50) and a control group who did not performed resistance exercise ( n =50). Resistance exercise was performed on the bioDensity™ resistance exercise instrument. The study graded the severity of diabetic peripheral neuropathy by the Toronto clinical scoring system (TCSS), and the improvement of diabetic peripheral neuropathy (DPN) was evaluated by the decline of the TCSS score. The observation group was treated with resistance exercise for 6 months. The changes of body mass index (BMI), waist circumference, hip circumference, systolic blood pressure, diastolic blood pressure, fasting blood glucose (FBG), fasting insulin (FINS), glycosylated hemoglobin (HbA1C), total cholesterol (TC), glycerin trilaurate (TG), low density lipoprotein (LDL), high density lipoprotein (HDL), and TCSS score were compared between baseline and 3, 6 months of exercise. At the same time, the differences in sensory test scores, nerve reflex scores, and neurological symptom scores were compared between the baseline, 3 and 6 months, in the observation group. Except for resistance exercise, the other treatments in the control group were the same as those in the observation group.
RESULTS
Compared with the control group, there was statistically difference in the TCSS scores in the observation group at 3 months ( P <0.05); there were also statistically difference in the HbA1C and TCSS scores in the observation group at 6 months (both P <0.05). The changes of TCSS scores, FBG, HbA1C in the observation group at 3 months and 6 months were significantly lower than those in the baseline, with significant differences (all P <0.05); but there were no significant differences in BMI, waist circumference, hip circumference, systolic blood pressure, diastolic blood pressure and TC, TG, LDL, HDL (all P >0.05). In the TCSS scores, the neurosymptom score, sensory test score were all reduced compared with the baseline, with significant differences (both P <0.05); but there was no significant difference in the neuroreflex score ( P >0.05). In the control group, the TG and TC at 3 and 6 months were decreased compared with the baseline, and there was significant difference (both P <0.05), while there was no significant difference in the other indicators (all P >0.05).
CONCLUSIONS
After the intervention of resistance exercise, the blood glucose and DPN can be improved in a certain extent, and which can be popularized in Type 2 diabetes patients.",2020,"In the TCSS scores, the neurosymptom score, sensory test score were all reduced compared with the baseline, with significant differences (both P <0.05); but there was no significant difference in the neuroreflex score ( P >0.05).","['Type 2 diabetes patients', 'patients with Type 2 diabetic peripheral neuropathy via resistance exercise', '100 patients with Type 2 diabetic peripheral neuropathy', 'Type 2 diabetes mellitus']","['observation group who performed resistance exercise', 'resistance exercise', 'Resistance exercise', 'control group who did not performed resistance exercise']","['neuroreflex score', 'TCSS scores, FBG, HbA1C', 'TCSS scores', 'neurosymptom score, sensory test score', 'HbA1C and TCSS scores', 'neurological symptoms', 'changes of body mass index (BMI), waist circumference, hip circumference, systolic blood pressure, diastolic blood pressure, fasting blood glucose (FBG), fasting insulin (FINS), glycosylated hemoglobin (HbA1C), total cholesterol (TC), glycerin trilaurate (TG), low density lipoprotein (LDL), high density lipoprotein (HDL), and TCSS score', 'peripheral neuropathy', 'BMI, waist circumference, hip circumference, systolic blood pressure, diastolic blood pressure and TC, TG, LDL, HDL', 'TG and TC', 'sensory test scores, nerve reflex scores, and neurological symptom scores', 'blood glucose and DPN', 'diabetic peripheral neuropathy (DPN']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0200116', 'cui_str': 'Sensory testing'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}]",100.0,0.0292988,"In the TCSS scores, the neurosymptom score, sensory test score were all reduced compared with the baseline, with significant differences (both P <0.05); but there was no significant difference in the neuroreflex score ( P >0.05).","[{'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Punan Hospital, Pudong New Area, Shanghai 200125, China. sxwnpcszyxr@126.com.'}, {'ForeName': 'Lianyong', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Punan Hospital, Pudong New Area, Shanghai 200125, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Punan Hospital, Pudong New Area, Shanghai 200125, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Punan Hospital, Pudong New Area, Shanghai 200125, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Punan Hospital, Pudong New Area, Shanghai 200125, China. 2257546231@qq.com.'}]",Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences,['10.11817/j.issn.1672-7347.2020.190505']
2285,33268562,Effects of ibudilast on MRI measures in the phase 2 SPRINT-MS study.,"OBJECTIVE
For progressive forms of multiple sclerosis, determine whether ibudilast has an effect on brain volume and new lesions.
METHODS
A randomized, placebo controlled, blinded study evaluated ibudilast at a dose of up to 100 mg over 96 weeks in primary and secondary progressive multiple sclerosis. In this secondary analysis of a previously reported trial, secondary and tertiary endpoints included gray matter atrophy, new or enlarging T2 lesions as measured every 24 weeks, and new T1 hypointensities at 96 weeks. Whole brain atrophy measured by SIENA was a sensitivity analysis.
RESULTS
129 participants were assigned to ibudilast and 126 to placebo. New or enlarging T2 lesions were observed in 37.2% on ibudilast and 29.0% on placebo (p=0.82). New T1 hypointense lesions at 96 weeks were observed in 33.3% on ibudilast and 23.5% on placebo (p=0.11). Gray matter atrophy was reduced by 35% for those on ibudilast vs. placebo (p=0.038). Progression of whole brain atrophy by SIENA was slowed by 20% in the ibudilast group compared with placebo (p=0.08).
CONCLUSIONS
Ibudilast treatment was associated with a reduction in gray matter atrophy. Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions, or new T1 lesions. An effect on brain volume contributes to prior data that ibudilast appears to impact markers associated with neurodegenerative processes, but not inflammatory processes.
CLASSIFICATION OF EVIDENCE
This study provides Class II evidence that for people with MS, ibudilast does not significantly reduce new or enlarging T2 lesions, or new T1 lesions.",2020,"Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions, or new T1 lesions.",['129 participants were assigned to ibudilast and 126 to'],['placebo'],"['Gray matter atrophy', 'gray matter atrophy', 'New T1 hypointense lesions', 'Progression of whole brain atrophy by SIENA', 'new or enlarging T2 lesions, or new T1 lesions', 'MRI measures', 'New or enlarging T2 lesions', 'gray matter atrophy, new or enlarging T2 lesions']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0123047', 'cui_str': 'ibudilast'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",129.0,0.177457,"Ibudilast treatment was not associated with a reduction in new or enlarging T2 lesions, or new T1 lesions.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Washington University, St. Louis, MO, USA naismithr@wustl.edu.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Bermel', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland OH, USA.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'Coffey', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Goodman', 'Affiliation': 'University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Janel', 'Initials': 'J', 'LastName': 'Fedler', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Kearney', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Klawiter', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kunio', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland OH, USA.'}, {'ForeName': 'Sridar', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'McConnell Brain Imaging Centre, Montreal Neurological Institute, McGill University, Quebec, Canada; NeuroRx Research, Montreal, Quebec, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Goebel', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland OH, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Yankey', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Klingner', 'Affiliation': 'University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Fox', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000011314']
2286,33268527,"Active conventional treatment and three different biological treatments in early rheumatoid arthritis: phase IV investigator initiated, randomised, observer blinded clinical trial.","OBJECTIVE
To evaluate and compare benefits and harms of three biological treatments with different modes of action versus active conventional treatment in patients with early rheumatoid arthritis.
DESIGN
Investigator initiated, randomised, open label, blinded assessor, multiarm, phase IV study.
SETTING
Twenty nine rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland between 2012 and 2018.
PARTICIPANTS
Patients aged 18 years and older with treatment naive rheumatoid arthritis, symptom duration less than 24 months, moderate to severe disease activity, and rheumatoid factor or anti-citrullinated protein antibody positivity, or increased C reactive protein.
INTERVENTIONS
Randomised 1:1:1:1, stratified by country, sex, and anti-citrullinated protein antibody status. All participants started methotrexate combined with (a) active conventional treatment (either prednisolone tapered to 5 mg/day, or sulfasalazine combined with hydroxychloroquine and intra-articular corticosteroids), (b) certolizumab pegol, (c) abatacept, or (d) tocilizumab.
MAIN OUTCOME MEASURES
The primary outcome was adjusted clinical disease activity index remission (CDAI≤2.8) at 24 weeks with active conventional treatment as the reference. Key secondary outcomes and analyses included CDAI remission at 12 weeks and over time, other remission criteria, a non-inferiority analysis, and harms.
RESULTS
812 patients underwent randomisation. The mean age was 54.3 years (standard deviation 14.7) and 68.8% were women. Baseline disease activity score of 28 joints was 5.0 (standard deviation 1.1). Adjusted 24 week CDAI remission rates were 42.7% (95% confidence interval 36.1% to 49.3%) for active conventional treatment, 46.5% (39.9% to 53.1%) for certolizumab pegol, 52.0% (45.5% to 58.6%) for abatacept, and 42.1% (35.3% to 48.8%) for tocilizumab. Corresponding absolute differences were 3.9% (95% confidence interval -5.5% to 13.2%) for certolizumab pegol, 9.4% (0.1% to 18.7%) for abatacept, and -0.6% (-10.1% to 8.9%) for tocilizumab. Key secondary outcomes showed no major differences among the four treatments. Differences in CDAI remission rates for active conventional treatment versus certolizumab pegol and tocilizumab, but not abatacept, remained within the prespecified non-inferiority margin of 15% (per protocol population). The total number of serious adverse events was 13 (percentage of patients who experienced at least one event 5.6%) for active conventional treatment, 20 (8.4%) for certolizumab pegol, 10 (4.9%) for abatacept, and 10 (4.9%) for tocilizumab. Eleven patients treated with abatacept stopped treatment early compared with 20-23 patients in the other arms.
CONCLUSIONS
All four treatments achieved high remission rates. Higher CDAI remission rate was observed for abatacept versus active conventional treatment, but not for certolizumab pegol or tocilizumab versus active conventional treatment. Other remission rates were similar across treatments. Non-inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept. The results highlight the efficacy and safety of active conventional treatment based on methotrexate combined with corticosteroids, with nominally better results for abatacept, in treatment naive early rheumatoid arthritis.
TRIAL REGISTRATION
EudraCT2011-004720-35, NCT01491815.",2020,"inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept.","['The mean age was 54.3 years (standard deviation 14.7) and 68.8% were women', 'Patients aged 18 years and older with treatment naive rheumatoid arthritis, symptom duration less than 24 months, moderate to severe disease activity, and rheumatoid factor or anti-citrullinated protein antibody positivity, or increased C reactive protein', '812 patients underwent randomisation', 'Twenty nine rheumatology departments in Sweden, Denmark, Norway, Finland, the Netherlands, and Iceland between 2012 and 2018', 'patients with early rheumatoid arthritis', 'Eleven patients treated with abatacept stopped treatment early compared with 20-23 patients in the other arms', 'early rheumatoid arthritis']","['sulfasalazine combined with hydroxychloroquine and intra-articular corticosteroids), (b) certolizumab pegol, (c) abatacept, or (d) tocilizumab', 'certolizumab pegol and tocilizumab', 'methotrexate combined with (a) active conventional treatment (either prednisolone', 'methotrexate combined with corticosteroids', 'tocilizumab', 'action versus active conventional treatment']","['CDAI remission at 12 weeks and over time, other remission criteria, a non-inferiority analysis, and harms', 'CDAI remission rates', 'total number of serious adverse events', 'Higher CDAI remission rate', 'adjusted clinical disease activity index remission', 'high remission rates', 'efficacy and safety', 'Baseline disease activity score', 'remission rates']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035448', 'cui_str': 'Rheumatoid factor'}, {'cui': 'C1445860', 'cui_str': 'Protein antibody'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0587479', 'cui_str': 'Rheumatology department'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0020750', 'cui_str': 'Iceland'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0036078', 'cui_str': 'Sulfasalazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1872109', 'cui_str': 'certolizumab pegol'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}]",812.0,0.239285,"inferiority analysis indicated that active conventional treatment was non-inferior to certolizumab pegol and tocilizumab, but not to abatacept.","[{'ForeName': 'Merete Lund', 'Initials': 'ML', 'LastName': 'Hetland', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark merete.hetland@dadlnet.dk.'}, {'ForeName': 'Espen A', 'Initials': 'EA', 'LastName': 'Haavardsholm', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rudin', 'Affiliation': 'Rheumatology Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Nordström', 'Affiliation': 'Division of Rheumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nurmohamed', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Reade, Netherlands.'}, {'ForeName': 'Bjorn', 'Initials': 'B', 'LastName': 'Gudbjornsson', 'Affiliation': 'Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Lampa', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hørslev-Petersen', 'Affiliation': 'Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Sønderborg, Denmark.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Uhlig', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Gerdur', 'Initials': 'G', 'LastName': 'Grondal', 'Affiliation': 'Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Marte S', 'Initials': 'MS', 'LastName': 'Heiberg', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Twisk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centres, Amsterdam, Netherlands.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lend', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Krabbe', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lise Hejl', 'Initials': 'LH', 'LastName': 'Hyldstrup', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna-Karin', 'Initials': 'AK', 'LastName': 'Hultgård Ekwall', 'Affiliation': 'Rheumatology Clinic, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Kathrine Lederballe', 'Initials': 'KL', 'LastName': 'Grøn', 'Affiliation': 'Copenhagen Center for Arthritis Research (COPECARE) and DANBIO, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Meliha', 'Initials': 'M', 'LastName': 'Kapetanovic', 'Affiliation': 'Section of Rheumatology, Department of Clinical Sciences Lund, Skåne University Hospital, Lund and Malmö, Sweden.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Faustini', 'Affiliation': 'Department of Medicine, Rheumatology Unit, Center for Molecular Medicine (CMM), Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Riitta', 'Initials': 'R', 'LastName': 'Tuompo', 'Affiliation': 'Division of Rheumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Lorenzen', 'Affiliation': 'Department of Rheumatology, Silkeborg University Clinic, Silkeborg, Denmark.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cagnotto', 'Affiliation': 'Department of Rheumatology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baecklund', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Hendricks', 'Affiliation': 'Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark, Sønderborg, Denmark.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Vedder', 'Affiliation': 'Amsterdam Rheumatology and Immunology Center, Reade, Netherlands.'}, {'ForeName': 'Tuulikki', 'Initials': 'T', 'LastName': 'Sokka-Isler', 'Affiliation': 'Department of Medicine and University of Eastern Finland, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Husmark', 'Affiliation': 'Department of Rheumatology, Falu Hospital, Falun, Sweden.'}, {'ForeName': 'Maud-Kristine Aga', 'Initials': 'MA', 'LastName': 'Ljoså', 'Affiliation': 'Department of Rheumatology, Ålesund Hospital, Ålesund, Norway.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Brodin', 'Affiliation': 'Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Torkell', 'Initials': 'T', 'LastName': 'Ellingsen', 'Affiliation': 'Rheumatology Research Unit, Odense University Hospital, Southern University of Denmark, Denmark.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Söderbergh', 'Affiliation': 'Department of Rheumatology, Örebro University Hospital, Örebro, Sweden.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Rizk', 'Affiliation': 'Rheumatology Clinic, Västmanlands Hospital Västerås, Sweden.'}, {'ForeName': 'Åsa Reckner', 'Initials': 'ÅR', 'LastName': 'Olsson', 'Affiliation': 'Department of Rheumatology, Linköping University Hospital, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Larsson', 'Affiliation': 'Academic Specialist Center, Stockholm, Sweden.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Uhrenholt', 'Affiliation': 'Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Søren Andreas', 'Initials': 'SA', 'LastName': 'Just', 'Affiliation': 'Section of Rheumatology, Department of Medicine, Svendborg Hospital OUH, Denmark.'}, {'ForeName': 'David John', 'Initials': 'DJ', 'LastName': 'Stevens', 'Affiliation': ""Department of Rheumatology, St Olav's Hospital, University Hospital of Trondheim, Trondheim, Norway.""}, {'ForeName': 'Trine Bay', 'Initials': 'TB', 'LastName': 'Laurberg', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Gunnstein', 'Initials': 'G', 'LastName': 'Bakland', 'Affiliation': 'Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Inge C', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Norway.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'van Vollenhoven', 'Affiliation': 'Department of Rheumatology and Amsterdam Rheumatology Center, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m4328']
2287,33268476,Designing a clinical trial of non-steroidal anti-inflammatory drugs for cancer pain: a survey of UK palliative care physicians.,"OBJECTIVES
Insufficient quality evidence exists to support or refute the use of non-steroidal anti-inflammatory drugs (NSAIDs) in the management of cancer pain. We aimed to determine the most clinically pragmatic design of a future randominsed controlled trial (RCT), based on how NSAIDs are currently used and perceived efficacy.
METHODS
An online survey was distributed to members of the Association for Palliative Medicine of Great Britain and Ireland examining NSAID use, indications and perceived efficacy, as well as duration of respondents' experience in palliative medicine.
RESULTS
23% of 968 members responded. A placebo-controlled trial of NSAIDs as a strong opioid adjunct in cancer-related bone pain was considered the most clinically pragmatic design. Concerning current practice, oral administration was the preferential route (79.4%), dosed regularly (79.5%). Selective cyclooxygenase-2 (COX-2) inhibitors and non-selective COX-2 inhibitors were considered similarly effective by 45% in cancer pain; ibuprofen being the first line oral NSAID of choice (42.6%). Treatment efficacy is generally determined within 1 week (94.3%). On a Likert scale, most physicians consider NSAIDs improve cancer pain either 'sometimes' (57.7%) or 'often' (40%). Years of specialist palliative care experience did not affect perception of efficacy (p=0.353).
CONCLUSIONS
A randomised controlled trial of NSAIDs as opioid adjuncts for cancer-related bone pain would be the most pragmatic design supported by palliative care clinicians to benefit clinical practice.",2020,"Years of specialist palliative care experience did not affect perception of efficacy (p=0.353).
","['cancer pain', '23% of 968 members responded']","['NSAIDs', 'placebo', 'steroidal anti-inflammatory drugs']","['Treatment efficacy', ""cancer pain either 'sometimes""]","[{'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}]",,0.0634868,"Years of specialist palliative care experience did not affect perception of efficacy (p=0.353).
","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Page', 'Affiliation': 'Academic Unit of Palliative Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK andrew.page1@nhs.net.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Mulvey', 'Affiliation': 'Academic Unit of Palliative Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Bennett', 'Affiliation': 'Academic Unit of Palliative Care, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002792']
2288,33268475,"'Advance care planning, general practitioners and patients: a phase II cluster-randomised controlled trial in chronic life-limiting illness'.","OBJECTIVES
Although general practice is an ideal setting for ensuring timely initiation of advance care planning (ACP) in people with chronic life-limiting illness, evidence on the effectiveness of ACP in general practice and how it can be implemented is lacking. This study aims to evaluate feasibility and acceptability of study procedures and intervention components of an intervention to facilitate the initiation of ACP in general practice for people with chronic life-limiting illness.
METHODS
Pilot cluster-randomised controlled trial testing a complex ACP intervention in general practice versus usual care (ClinicalTrials.gov: NCT02775032). We used a mixed methods approach using detailed documentation of the recruitment process, questionnaires and semi-structured interviews.
RESULTS
A total of 25 general practitioners (GPs) and 38 patients were enrolled in the study. The intervention was acceptable to GPs and patients, with GPs valuing the interactive training and patients finding ACP conversations useful. However, we found a number of challenges regarding feasibility of recruitment procedures, such GP as recruitment proceeding more slowly than anticipated as well as difficulty applying the inclusion criteria for patients. Some GPs found initiating ACP conversations difficult. The content of the patient booklet was determined to potentially be too complex for patients with a lower health literacy.
CONCLUSION
Although the intervention was well-accepted by GPs and patients, we identified critical points for improvement with regard to the study procedures as well as potential improvements of the intervention components. When these points are addressed, the intervention can proceed to a large-scale, phase III trial to test its effectiveness.",2020,"The intervention was acceptable to GPs and patients, with GPs valuing the interactive training and patients finding ACP conversations useful.","['people with chronic life-limiting illness', 'patients with a lower health literacy', '25 general practitioners (GPs) and 38 patients were enrolled in the study']","['GPs valuing the interactive training', 'ACP', 'complex ACP intervention']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],38.0,0.0885084,"The intervention was acceptable to GPs and patients, with GPs valuing the interactive training and patients finding ACP conversations useful.","[{'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Dierickx', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium Sigrid.Dierickx@ugent.be.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Pardon', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pype', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vander Stichele', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Deliens', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'De Vleminck', 'Affiliation': 'End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University, Brussels, Belgium.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002712']
2289,33268434,Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial.,"INTRODUCTION
Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, endoscopic polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.
METHODS AND ANALYSIS
We designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire.We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period.
ETHICS AND DISSEMINATION
This study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board.
TRIAL REGISTRATION NUMBER
NCT02975310.",2020,"There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.
","['chronic rhinosinusitis with nasal polyps', '140 patients from sites across Canada']","['EPIC or ESS', 'EPIC', 'Endoscopic polypectomy', 'CRS with nasal polyps (CRSwNP']","['Sinonasal Outcome Test-22 score', 'peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429205', 'cui_str': 'Nasal peak inspiratory flow'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",140.0,0.242402,"There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.
","[{'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Kilty', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada skilty@toh.ca.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Janjua', 'Affiliation': 'Department of Surgery, Division of Otolaryngology-Head and Neck Surgery, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': ""Department of Otolaryngology-Head and Neck Surgery, Saint Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'MacDonald', 'Affiliation': 'Department of Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Meen', 'Affiliation': 'Department of Otolaryngology, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Micomonaco', 'Affiliation': 'Department of Clinical Sciences, Northern Ontario School of Medicine, Thunder Bay, Ontario, Canada.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Rotenberg', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Leigh J', 'Initials': 'LJ', 'LastName': 'Sowerby', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Tewfik', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Adams', 'Affiliation': 'Patient Representative, Ottawa, Ontario, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Frenette', 'Affiliation': 'Patient Representative, Ottawa, Ontario, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lasso', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2020-042413']
2290,33268431,"The DemWG study: reducing the risk of hospitalisation through a complex intervention for people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements: study protocol of a prospective, mixed-methods, multicentre, cluster-randomised controlled trial.","INTRODUCTION
Shared-housing arrangements (SHAs) are small, home-like care environments in Germany. Residents are predominantly people with dementia. The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation. Thus, the DemWG study investigates whether a complex intervention is effective in reducing hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life in people with dementia and mild cognitive impairment (MCI) in German SHAs.
METHODS AND ANALYSIS
Based on the UK Medical Research Council framework 'Developing and evaluating complex interventions', a prospective, mixed-methods, multicentre, cluster-randomised controlled trial combining primary and secondary data analyses as well as quantitative and qualitative research methods is being conducted. The intervention consists of three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ ('m'=motor training; 'k'=cognitive training; '+'=fall prevention) for people with dementia and MCI. Randomisation is stratified by the German federal states and type of setting (rural vs urban). Neither the trained professionals nor the participants are blinded. Data are collected at baseline and after 6, 12 and 18 months with standardised instruments. Quantitative data will be analysed by multivariate analyses according to the general linear model, qualitative data using qualitative content analysis. Recruitment is still ongoing until 31 December 2020.
ETHICS AND DISSEMINATION
All procedures were approved by the Ethics Committee of the University of Bremen (Ref. 2019-18-06-3). Informed consent will be obtained before enrolment of participants. Due to findings of previous randomised controlled trials, serious adverse events are not expected. Results will be disseminated in peer-reviewed journal publications and conference presentations.
TRIAL REGISTRATION NUMBER
ISRCTN89825211.",2020,The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation.,"['people with dementia and mild cognitive impairment (MCI) in German SHAs', 'Residents are predominantly people with dementia', 'people with dementia and mild cognitive impairment (MCI) in German shared-housing arrangements', 'people with dementia and MCI']","['complex intervention', ""three parts: (A) education of nursing staff in SHAs; (B) awareness raising and continuing medical education (CME) of general practitioners; (C) multicomponent non-pharmacological group intervention MAKS-mk+ ('m'=motor training; 'k'=cognitive training; '+'=fall prevention""]","['hospitalisation (primary outcome), behavioural and psychological symptoms of dementia and falls and for stabilising cognitive functioning and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0013632', 'cui_str': 'Continuing Medical Education'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.208792,The risk for all-cause hospitalisation is consistently higher for people with dementia compared with people without dementia and there is currently no evidence-based intervention to reduce the risk of hospitalisation.,"[{'ForeName': 'André', 'Initials': 'A', 'LastName': 'Kratzer', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany andre.kratzer@uk-erlangen.de.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scheel', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Wolf-Ostermann', 'Affiliation': 'Department of Health Care Research, Institute of Public Health and Nursing Research (IPP), University of Bremen, Bremen, Germany.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Department of Health Care Research, Institute of Public Health and Nursing Research (IPP), University of Bremen, Bremen, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Ratz', 'Affiliation': 'Department of Health Care Research, Institute of Public Health and Nursing Research (IPP), University of Bremen, Bremen, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Donath', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Graessel', 'Affiliation': 'Centre for Health Services Research in Medicine, Department of Psychiatry and Psychotherapy, University Hospital Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-041891']
2291,33268429,Study protocol for evaluation of aid to diagnosis for developmental dysplasia of the hip in general practice: controlled trial randomised by practice.,"INTRODUCTION
In the UK, a compulsory '6-week hip check' is performed in primary care for the detection of developmental dysplasia of the hip (DDH). However, missed diagnoses and infants incorrectly labelled with DDH remain a problem, potentially leading to adverse consequences for infants, their families and the National Health Service. National policy states that infants should be referred to hospital if the 6-week check suggests DDH, though there is no available tool to aid examination or offer guidelines for referral. We developed standardised diagnostic criteria for DDH, based on international Delphi consensus, and a 9-item checklist that has the potential to enable non-experts to diagnose DDH in a manner approaching that of experts.
METHODS AND ANALYSIS
We will conduct a controlled trial randomised by practice that will compare a diagnostic aid against standard care for the hip check. The primary objective is to determine whether an aid to the diagnosis of DDH reduces the number of clinically insignificant referrals from primary care to hospital and the number of late diagnosed DDH. The trial will include a qualitative process evaluation, an assessment of professional behavioural change and a full health economic evaluation. We will recruit 152 general practitioner practices in England. These will be randomised to conduct the hip checks with use of the study diagnostic aid and/or as per usual practice. The total number of infants seen during a 15-month recruitment period will be 110 per practice. Two years after the 6-week hip check, we will measure the number of referred infants that are (1) clinically insignificant for DDH and (2) those that constitute appropriate referrals.
ETHICS AND DISSEMINATION
This study has approval from the Health Research Authority (16/1/2020) and the Confidentiality Advisory Group (18/2/2020). Results will be published in peer-reviewed academic journals, disseminated to patient organisations and the media.
TRIAL REGISTRATION NUMBER
NCT04101903; Pre-results.",2020,The primary objective is to determine whether an aid to the diagnosis of DDH reduces the number of clinically insignificant referrals from primary care to hospital and the number of late diagnosed DDH.,"['developmental dysplasia of the hip in general practice', '152 general practitioner practices in England']",[],[],"[{'cui': 'C4551649', 'cui_str': 'Congenital hip dysplasia'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],[],152.0,0.0960307,The primary objective is to determine whether an aid to the diagnosis of DDH reduces the number of clinically insignificant referrals from primary care to hospital and the number of late diagnosed DDH.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Roposch', 'Affiliation': 'Great Ormond Street Institute of Child Health, UCL, London, UK a.roposch@ucl.ac.uk.'}, {'ForeName': 'Kaltuun', 'Initials': 'K', 'LastName': 'Warsame', 'Affiliation': 'Great Ormond Street Institute of Child Health, UCL, London, UK.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Chater', 'Affiliation': 'Department of Sport Science and Physical, University of Bedfordshire, Luton, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Department of Population Health Sciences, Kings College London, London, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, UCL, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'PRIMENT Clinical Trials Unit, UCL, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Freemantle', 'Affiliation': 'Comprehensive Clinical Trials Unit, UCL, London, UK.'}, {'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Nazareth', 'Affiliation': 'Research Department of Primary Care and Population Health, UCL, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-041837']
2292,33268424,"Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasaï, Democratic Republic of Congo.","INTRODUCTION
Acute malnutrition (AM) is a continuum condition, arbitrarily divided into moderate and severe AM (SAM) categories, funded and managed in separate programmes under different protocols. Optimising acute MAlnutrition (OptiMA) treatment aims to simplify and optimise AM management by treating children with mid-upper arm circumference (MUAC) <125 mm or oedema with one product-ready-to-use therapeutic food-at a gradually tapered dose. Our main objective was to compare the OptiMA strategy with the standard nutritional protocol in children 6-59 months presenting with MUAC <125 mm or oedema without additional complications, as well as in children classified as uncomplicated SAM (ie, MUAC <115 mm or weight-for-height Z-score (WHZ) <-3 or with oedema).
METHODS AND ANALYSIS
This study was a non-inferiority, individually randomised controlled clinical trial conducted at community level in the Democratic Republic of Congo. Children 6-59 months presenting with MUAC <125 mm or WHZ <-3 or with bipedal oedema and without medical complication were included after signed informed consent in outpatient health facilities. All participants were followed for 6 months. Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period. Recovery among children with uncomplicated SAM was the main secondary outcome. For the primary objective, 890 participants were needed, and 480 children with SAM were needed for the main secondary objective. We will perform non-inferiority analyses in per-protocol and intention-to-treat basis for both outcomes.
ETHICS AND DISSEMINATION
Ethics approvals were obtained from the National Health Ethics Committee of the Democratic Republic of Congo and from the Ethics Evaluation Committee of Inserm, the French National Institute for Health and Medical Research (Paris, France). We will submit results for publication to a peer-reviewed journal and disseminate findings in international and national conferences and meetings.
TRIAL REGISTRATION NUMBER
NCT03751475. Registered 19 September 2018, https://clinicaltrials.gov/ct2/show/NCT03751475.",2020,"Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period.","['children with uncomplicated SAM', 'children 6-59 months presenting with MUAC <125\u2009mm or oedema without additional complications, as well as in children classified as uncomplicated SAM (ie, MUAC <115\u2009mm or weight-for-height Z-score (WHZ) <-3 or with oedema', 'children aged 6 to 59 months: study protocol for a community-based individually randomised controlled trial in Kasaï, Democratic Republic of Congo', 'children with mid-upper arm circumference (MUAC) <125\u2009mm or oedema with one product-ready-to-use therapeutic food-at a gradually tapered dose', 'Children 6-59 months presenting with MUAC <125\u2009mm or WHZ <-3 or with bipedal oedema and without medical complication were included after signed informed consent in outpatient health facilities', 'community level in the Democratic Republic of Congo', '890 participants were needed, and 480 children with SAM']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043444', 'cui_str': 'Zaire'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C4319609', 'cui_str': '480'}]",[],[],890.0,0.236807,"Success in both arms was defined at 6 months post inclusion as being alive, not acutely malnourished per the definition applied at inclusion and without an additional episode of AM throughout the 6-month observation period.","[{'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Cazes', 'Affiliation': 'University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team IDLIC, UMR 1219, Bordeaux, France cecile.cazes@u-bordeaux.fr.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Phelan', 'Affiliation': 'The Alliance for International Medical Action (ALIMA), Paris, France.'}, {'ForeName': 'Victoire', 'Initials': 'V', 'LastName': 'Hubert', 'Affiliation': 'The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of Congo.'}, {'ForeName': 'Rodrigue', 'Initials': 'R', 'LastName': 'Alitanou', 'Affiliation': 'The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of Congo.'}, {'ForeName': 'Harouna', 'Initials': 'H', 'LastName': 'Boubacar', 'Affiliation': 'The Alliance for International Medical Action (ALIMA), Kamuesha, Democratic Republic of Congo.'}, {'ForeName': 'Liévin', 'Initials': 'L', 'LastName': 'Izie Bozama', 'Affiliation': 'National Nutrition Programme (PRONANUT), Ministry of Health, Kinshasa, Democratic Republic of Congo.'}, {'ForeName': 'Gilbert', 'Initials': 'G', 'LastName': 'Tshibangu Sakubu', 'Affiliation': 'Kamuesha Health Zone in the Kasaï Province, Ministry of Health, Kamuesha, Democratic Republic of Congo.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Beuscart', 'Affiliation': 'University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team IDLIC, UMR 1219, Bordeaux, France.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': ""PACCI Research Programme, University Hospital of Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': 'University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team IDLIC, UMR 1219, Bordeaux, France.'}, {'ForeName': 'Moumouni', 'Initials': 'M', 'LastName': 'Kinda', 'Affiliation': 'The Alliance for International Medical Action (ALIMA), Dakar, Senegal.'}, {'ForeName': 'Augustin', 'Initials': 'A', 'LastName': 'Augier', 'Affiliation': 'The Alliance for International Medical Action (ALIMA), Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': 'University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team IDLIC, UMR 1219, Bordeaux, France.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Shepherd', 'Affiliation': 'The Alliance for International Medical Action (ALIMA), Dakar, Senegal.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Becquet', 'Affiliation': 'University of Bordeaux, Inserm, French National Research Institute for Sustainable Development (IRD), Bordeaux Population Health Research Center, Team IDLIC, UMR 1219, Bordeaux, France.'}]",BMJ open,['10.1136/bmjopen-2020-041213']
2293,33268419,Randomised controlled trial for high-dose intravenous zinc as adjunctive therapy in SARS-CoV-2 (COVID-19) positive critically ill patients: trial protocol.,"INTRODUCTION
SARS-CoV-2 (COVID-19) has caused an international pandemic of respiratory illness, resulting in significant healthcare and economic turmoil. To date, no robust vaccine or treatment has been identified. Elemental zinc has previously been demonstrated to have beneficial effects on coronaviruses and other viral respiratory infections due to its effect on RNA polymerase. Additionally, zinc has well-demonstrated protective effects against hypoxic injury-a clear mechanism of end-organ injury in respiratory distress syndrome. We aimed to assess the effect of high-dose intravenous zinc (HDIVZn) on SARS-CoV-2 infection. The end of study analyses will evaluate the reduction of impact of oxygen saturations or requirement of oxygen supplementation.
METHODS AND ANALYSIS
We designed a double-blind randomised controlled trial of daily HDIVZn (0.5 mg/kg) versus placebo. Primary outcome measures are lowest oxygen saturation (or greatest level of supplemental oxygenation) for non-ventilated patients and worst PaO 2 /FiO 2 for ventilated patients. Following power calculations, 60 hospitalised patients and 100 ventilated patients will be recruited to demonstrate a 20% difference. The duration of follow-up is up to the point of discharge.
ETHICS AND DISSEMINATION
Ethical approval was obtained through the independent Human Research Ethics Committee. Participant recruitment will commence in May 2020. Results will be published in peer-reviewed medical journals.
TRIAL REGISTRATION NUMBER
ACTRN126200000454976.",2020,Primary outcome measures are lowest oxygen saturation (or greatest level of supplemental oxygenation) for non-ventilated patients and worst PaO 2 /FiO 2 for ventilated patients.,"['SARS-CoV-2 (COVID-19) positive critically ill patients', '60 hospitalised patients and 100 ventilated patients']","['daily HDIVZn', 'intravenous zinc', 'placebo', 'high-dose intravenous zinc (HDIVZn']",['lowest oxygen saturation (or greatest level of supplemental oxygenation'],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",,0.78845,Primary outcome measures are lowest oxygen saturation (or greatest level of supplemental oxygenation) for non-ventilated patients and worst PaO 2 /FiO 2 for ventilated patients.,"[{'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Perera', 'Affiliation': 'Department of Surgery, Austin Health, Heidelberg, Victoria, Australia marlonlperera@gmail.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'El Khoury', 'Affiliation': 'Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Vidyasagar', 'Initials': 'V', 'LastName': 'Chinni', 'Affiliation': 'Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Bolton', 'Affiliation': 'Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Qu', 'Affiliation': 'Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Johnson', 'Affiliation': 'Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Trubiano', 'Affiliation': 'Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Christine F', 'Initials': 'CF', 'LastName': 'McDonald', 'Affiliation': 'Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Intensive Care Unit Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Intensive Care Unit Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Oneel', 'Initials': 'O', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ischia', 'Affiliation': 'Department of Surgery, Austin Health, Heidelberg, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040580']
2294,33268417,Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH): study protocol for a hybrid effectiveness-implementation cluster randomised trial.,"INTRODUCTION
Successfully transitioning adolescents to adult HIV care is critical for optimising outcomes. Disclosure of HIV status, a prerequisite to transition, remains suboptimal in sub-Saharan Africa. Few interventions have addressed both disclosure and transition. An adolescent transition package (ATP) that combines disclosure and transition tools could support transition and improve outcomes.
METHODS AND ANALYSIS
In this hybrid type 1 effectiveness-implementation cluster randomised controlled trial, 10 HIV clinics with an estimated ≥100 adolescents and young adults age 10-24 living with HIV (ALWHIV) in Kenya will be randomised to implement the ATP and compared with 10 clinics receiving standard of care. The ATP includes provider tools to assist disclosure and transition. Healthcare providers at intervention clinics will receive training on ATP use and support to adapt it through continuous quality improvement cycles over the initial 6 months of the study, with continued implementation for 1 year. The primary outcome is transition readiness among ALWHIV ages 15-24 years, assessed 6 monthly using a 22-item readiness score. Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes. The primary analysis will be intent to treat, using mixed-effects linear regression models to compare transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments. We will estimate the coefficients and 95% CIs with a two- sided α=0.05.
ETHICS AND DISSEMINATION
The study was approved by the University of Washington Institutional Review Board and the Kenyatta National Hospital Ethics and Research Committee. Study results will be shared with participating facilities, county and national policy-makers.
TRIALS REGISTRATION NUMBER
NCT03574129; Pre-results.",2020,"Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes.","['10 HIV clinics with an estimated ≥100 adolescents and young adults age 10-24 living with HIV (ALWHIV) in Kenya', 'Adolescent transition to adult care for HIV-infected adolescents in Kenya (ATTACH']",['10 clinics receiving standard of care'],"['transition readiness among ALWHIV ages 15-24 years, assessed 6 monthly using a 22-item readiness score', 'transition readiness scores (overall and by domain (HIV literacy, self-management, communication, support)) over time in control and intervention sites with adjustment for multiple testing, accounting for clustering by clinic and repeated assessments', 'retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C3178922', 'cui_str': 'Pediatric Transition To Adult Care'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",10.0,0.179408,"Secondary outcomes including retention and viral suppression among ALWHIV at the end of the intervention period (month 18), implementation outcomes (acceptability, feasibility, fidelity, coverage and penetration) and programme costs complement effectiveness outcomes.","[{'ForeName': 'Irene N', 'Initials': 'IN', 'LastName': 'Njuguna', 'Affiliation': 'Research and Programs, Kenyatta National Hospital, Nairobi, Kenya njugunairene06@yahoo.com.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Beima-Sofie', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Caren W', 'Initials': 'CW', 'LastName': 'Mburu', 'Affiliation': 'Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Mugo', 'Affiliation': 'Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Neary', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Itindi', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Onyango', 'Affiliation': 'University of Nairobi, Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Rubin Means', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Monisha', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Anjuli D', 'Initials': 'AD', 'LastName': 'Wagner', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Oyiengo', 'Affiliation': 'Neonatal and Child Health Services, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Dalton', 'Initials': 'D', 'LastName': 'Wamalwa', 'Affiliation': 'Pediatrics and Child Health, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Global Health, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2020-039972']
2295,33268416,Effects of a peer co-facilitated educational programme for parents of children with ADHD: a feasibility randomised controlled trial protocol.,"INTRODUCTION
Significant numbers of children with attention deficit hyperactivity disorder (ADHD) display problems that cause multiple disabilities, deficits and handicaps that interfere with social relationships, development and school achievement. They may have multiple problems, which strain family dynamics and influence the child's treatment. Parent activation, described as parents' knowledge, skills and confidence in dealing with their child's health and healthcare, has been shown to be an important factor in improving health outcomes. Research suggests that parents need edification to learn skills crucial to the treatment and management of their children's healthcare. Promoting positive parenting techniques may reduce negative parenting factors in families. This study aims to assess the acceptability, feasibility and estimated sample size of a randomised controlled trial (RCT) comparing an ADHD peer co-led educational programme added to treatment as usual (TAU).
METHODS AND ANALYSIS
Using a randomised waitlist controlled trial, parents of children aged 6-12 years newly diagnosed with ADHD, and referred to a child mental health outpatient clinic in Mid-Norway, will receive TAU concomitant with a peer co-facilitated parental engagement educational programme (n=25). Parents in the control group will receive TAU, and the educational programme treatment within a waitlist period of 3-6 months (n=25). Parent activation, satisfaction, well-being, quality of life and treatment adherence, will be assessed at baseline (T0), 2 weeks (T1) pre-post intervention (T2, T3) and at 3 months follow-up (T4). Shared decision making, parents preferred role in health-related decisions and involvement, parent-reported symptoms of ADHD and child's overall level of functioning will be assessed at T0 and T4. Such data will be used to calculate the required sample size for a full-scale RCT.
ETHICS AND DISSEMINATION
Approval was obtained from the Regional Committee for Medicine and Health Research Ethics in Mid-Norway (ref: 2018/1196). The findings of this study are expected to provide valuable knowledge about how to optimise family education and management of ADHD and will be disseminated through presentations at conferences and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04010851.",2020,"Parent activation, described as parents' knowledge, skills and confidence in dealing with their child's health and healthcare, has been shown to be an important factor in improving health outcomes.","['children with attention deficit hyperactivity disorder (ADHD', 'parents of children with ADHD', 'parents of children aged 6-12 years newly diagnosed with ADHD, and referred to a child mental health outpatient clinic in Mid-Norway, will receive TAU concomitant with a peer co-facilitated parental engagement educational programme (n=25', 'families']","['peer co-facilitated educational programme', 'ADHD peer co-led educational programme']","['Parent activation, satisfaction, well-being, quality of life and treatment adherence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}]",,0.270701,"Parent activation, described as parents' knowledge, skills and confidence in dealing with their child's health and healthcare, has been shown to be an important factor in improving health outcomes.","[{'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Mundal', 'Affiliation': 'Department of Mental Health, Faculty of medicine and health sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway ingunn.p.mundal@ntnu.no.'}, {'ForeName': 'Rolf W', 'Initials': 'RW', 'LastName': 'Gråwe', 'Affiliation': 'Department of Mental Health, Faculty of medicine and health sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Hafstad', 'Affiliation': 'Division of Mid-Norway, Vårres Regional User Involvement Centre, Trondheim, Norway.'}, {'ForeName': 'Carlos De Las', 'Initials': 'CL', 'LastName': 'Cuevas', 'Affiliation': 'Department of Internal Medicine, Dermatology and Psychiatry, Universidad de La Laguna, San Cristóbal de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Mariela Loreto', 'Initials': 'ML', 'LastName': 'Lara-Cabrera', 'Affiliation': 'Department of Mental Health, Faculty of medicine and health sciences, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.'}]",BMJ open,['10.1136/bmjopen-2020-039852']
2296,33268410,Exclusion of enrolled participants in randomised controlled trials: what to do with ineligible participants?,"OBJECTIVE
Post-randomisation exclusions in randomised controlled trials are common and may include participants identified as not meeting trial eligibility criteria after randomisation. We report how a decision might be reached and reported on, to include or exclude these participants. We illustrate using a motivating scenario from the BREATHE trial (Trial registration ClinicalTrials.gov, NCT02426112) evaluating azithromycin for the treatment of chronic lung disease in people aged 6-19 years with HIV in Zimbabwe and Malawi.
KEY POINTS
Including all enrolled and randomised participants in the primary analysis of a trial ensures an unbiased estimate of the intervention effect using intention-to-treat principles, and minimises the effects of confounding through balanced allocation to trial arm. Ineligible participants are sometimes enrolled, due to measurement or human error. Of 347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria. We assumed no safety risk of azithromycin treatment; their inclusion in the trial and subsequent analysis of the intervention effect therefore mirrors clinical practice. Senior trial investigators considered diurnal variations in the measurement of lung function, advantages of retaining a higher sample size and advice from the Data Safety and Monitoring Board and Trial Steering Committee, and decided to include these participants in primary analysis. We planned and reported analyses including and excluding these participants, and in our case the interpretation of treatment effect was consistent.
CONCLUSION
The decision, by senior investigators, on whether to exclude enrolled participants, should reflect issues of safety, treatment efficacy, statistical power and measurement error. As long as decisions are made prior to finalising the statistical analysis plan for the trial, the risk of exclusions creating bias should be minimal. The decision taken should be transparently reported and a sensitivity analysis can present the opposite decision.",2020,"Of 347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria.","['chronic lung disease in people aged 6-19\u2009years with HIV in Zimbabwe and Malawi', '347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria']",['azithromycin'],[],"[{'cui': 'C0746102', 'cui_str': 'Chronic lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],347.0,0.270452,"Of 347 participants enrolled into the BREATHE trial, 11 (3.2%) were subsequently found to be ineligible based on lung function criteria.","[{'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Rehman', 'Affiliation': 'MRC International Statistics & Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK andrea.rehman@lshtm.ac.uk.'}, {'ForeName': 'Rashida', 'Initials': 'R', 'LastName': 'Ferrand', 'Affiliation': 'Department of Clinical Research, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allen', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Simms', 'Affiliation': 'MRC International Statistics & Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'McHugh', 'Affiliation': 'Biomedical Research and Training Institute, Harare, Zimbabwe.'}, {'ForeName': 'Helen Anne', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC International Statistics & Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039546']
2297,33268409,Feasibility and acceptability study on the use of a smartphone application to facilitate balance training in the ageing population.,"OBJECTIVES
This study aims to investigate the feasibility and acceptability of using an app-based technology to train balance in the older population.
DESIGN
Prospective feasibility study.
SETTING
The study was conducted in a university setting and participants' homes.
PARTICIPANTS
Thirty-five volunteers ≥55 years old were recruited.
INTERVENTION
Participants were asked to follow a balance exercise programme 7 days a week for 3 weeks using a phone application. Seventeen participants trained for a further 3 weeks.
OUTCOME MEASURES
Postural sway measures during quiet standing with feet at shoulder width apart and feet together, one leg standing and tandem stance were measured at baseline, and at the end of the 3 and 6 training weeks; the International Physical Activity Questionnaire (IPAQ) assessed participants' physical activity level before training; and app acceptability was recorded using a user experience questionnaire.
RESULTS
Participants on the 3 and 6-week programme on average completed 20 (±5) and 38 (±11) days of training, respectively, and all scored moderate to high on the IPAQ. Between baseline and the 3-week assessments, statistically significant improvements were observed for anteroposterior sway, mediolateral sway, sway area during tandem stance, for anteroposterior sway during one leg standing and for sway area during feet together stance. Improvements were observed at 6 week compared with baseline but those between 3 and 6 weeks were not significant. Based on the questionnaire, participants reported that the app is an appropriate tool for balance training (77%), they reported benefits from the training (50%) and found it easy to fit it into daily routine (88%).
CONCLUSION
The high level of adherence and improvements observed in the analysed measures demonstrate the feasibility of using an app to train balance in moderately to highly physically active older participants. This demonstrates that given appropriate tools the older population is positive towards and receptive of digital interventions aimed to improve balance.",2020,"Between baseline and the 3-week assessments, statistically significant improvements were observed for anteroposterior sway, mediolateral sway, sway area during tandem stance, for anteroposterior sway during one leg standing and for sway area during feet together stance.","['ageing population', 'Thirty-five volunteers ≥55\u2009years old were recruited', ""The study was conducted in a university setting and participants' homes"", 'older population', 'Seventeen participants trained for a further 3 weeks']","['smartphone application to facilitate balance training', 'balance exercise programme']","['feasibility and acceptability', 'anteroposterior sway, mediolateral sway, sway area during tandem stance, for anteroposterior sway during one leg standing and for sway area during feet together stance', ""International Physical Activity Questionnaire (IPAQ) assessed participants' physical activity level before training; and app acceptability"", 'Postural sway measures during quiet standing with feet at shoulder width apart and feet together, one leg standing and tandem stance']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",35.0,0.0235127,"Between baseline and the 3-week assessments, statistically significant improvements were observed for anteroposterior sway, mediolateral sway, sway area during tandem stance, for anteroposterior sway during one leg standing and for sway area during feet together stance.","[{'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Papi', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK e.papi@imperial.ac.uk.'}, {'ForeName': 'Shin-Yi', 'Initials': 'SY', 'LastName': 'Chiou', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Alison H', 'Initials': 'AH', 'LastName': 'McGregor', 'Affiliation': 'Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039054']
2298,33268406,Restaurant interventions for salt reduction in China: protocol for a randomised controlled trial.,"INTRODUCTION
Salt intake in China is high, and most of it comes from that added by consumers. Nevertheless, recent years have seen a rapid increase in the frequency at which people eat out. The aim of this study is to evaluate the effectiveness of interventions designed for salt reduction in restaurants through a randomised controlled trial in China.
METHODS AND ANALYSIS
As a randomised controlled trial with restaurants as study subjects, we recruited 192 restaurants from 12 counties of 6 provinces in China. After the baseline survey, restaurants were randomly assigned to intervention or control group. Using social cognitive theory, comprehensive intervention activities were designed to encourage salt reduction in all restaurant foods, and at the same time, to encourage consumers to choose lower salt options when eating out. The interventions will be conducted only in restaurants of the intervention group during the first year. The follow-up assessment will be conducted at the end of the trial. The primary outcome is the change in the average salt content of the five best-selling dishes of the restaurant, as measured by laboratory tests. Secondary outcomes include differences in the monthly use of salt and salty condiments between intervention and control restaurants, and the knowledge, attitude and practice on salt among restaurant consumers.
ETHICS AND DISSEMINATION
The study was reviewed and approved by the Review Board of the National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention and Queen Mary Research Ethics Committee. Results will be disseminated through presentations, publications and social media.
TRIAL REGISTRATION NUMBER
ChiCTR1800019694; Pre-results.",2020,"Secondary outcomes include differences in the monthly use of salt and salty condiments between intervention and control restaurants, and the knowledge, attitude and practice on salt among restaurant consumers.
","['study subjects, we recruited 192 restaurants from 12 counties of 6 provinces in China']",['Restaurant interventions'],"['average salt content of the five best-selling dishes of the restaurant, as measured by laboratory tests', 'monthly use of salt and salty condiments between intervention and control restaurants, and the knowledge, attitude and practice on salt among restaurant consumers']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2742135', 'cui_str': 'SELL protein, human'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0009644', 'cui_str': 'Condiments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",192.0,0.067652,"Secondary outcomes include differences in the monthly use of salt and salty condiments between intervention and control restaurants, and the knowledge, attitude and practice on salt among restaurant consumers.
","[{'ForeName': 'Wenwen', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Jiguo', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Heilongjiang Provincial Center for Disease Control and Prevention, Harbin, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Qinghai Provincial Center for Disease Control and Prevention, Xining, China.'}, {'ForeName': 'Yifu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Hunan Provincial Center for Disease Control and Prevention, Changsha, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': 'Sichuan Provincial Center for Disease Control and Prevention, Chengdu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Jiangxi Provincial Center for Disease Control and Prevention, Nanchang, China.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Graham A', 'Initials': 'GA', 'LastName': 'MacGregor', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Luo', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Puhong', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China wanghj@ninh.chinacdc.cn zpuhong@georgeinstitute.org.cn.'}, {'ForeName': 'Huijun', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Center for Disease Control and Prevention, Beijing, China wanghj@ninh.chinacdc.cn zpuhong@georgeinstitute.org.cn.'}]",BMJ open,['10.1136/bmjopen-2020-038744']
2299,33268401,Comparison of a progestin-primed ovarian stimulation protocol with a flexible GnRH antagonist protocol in patients with polycystic ovary syndrome who are participating in an IVF programme: study protocol for a randomised controlled trial.,"INTRODUCTION
Women with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization (IVF) protocols are typically characterised by an increased number of oocytes retrieved. The oocytes are often of poor quality, leading to lower pregnancy rates, higher miscarriage rates and an increased risk of developing ovarian hyperstimulation syndrome (OHSS). Since our previous preliminary study showed that a novel progestin-primed ovarian stimulation (PPOS) protocol blocked the luteinising hormone (LH) surge during IVF and achieved a higher pregnancy rate with a lower incidence of OHSS, we designed a prospective randomised controlled trial to compare the efficacy and safety of this PPOS protocol with the flexible gonadotropin-releasing hormone (GnRH) antagonist protocol in patients with PCOS who are undergoing IVF procedures.
METHODS AND ANALYSIS
Patients with PCOS will be randomised to one of two controlled ovarian stimulation regimens-GnRH antagonist or PPOS-using a computer-generated random number. A freeze-all strategy using embryo vitrification techniques and frozen embryo transfer will be performed in both groups. The primary outcome is the live-birth rate per transfer. Secondary outcomes include the incidence of premature LH surges, the duration and total dose of human menopausal gonadotropin stimulation, the number of oocytes retrieved, the incidence of moderate or severe OHSS, the number of embryos available for transfer, implantation rates, clinical pregnancy rates, pregnancy loss rates, ectopic pregnancy rates, pregnancy and neonatal complications, and congenital anomalies. The necessary sample size for this trial was estimated as 392 participants, with 196 participants in each group. Intention-to-treat analysis was used in processing our experimental data.
ETHICS AND DISSEMINATION
This study was approved by the Institutional Review Board of the hospital (2016-133-T82). The trial will be conducted according to the principles of the World Medical Association's Declaration of Helsinki and in accordance with Good Clinical Practice standards. The findings of this trial will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ChiCTRIPR16009580.",2020,"The oocytes are often of poor quality, leading to lower pregnancy rates, higher miscarriage rates and an increased risk of developing ovarian hyperstimulation syndrome (OHSS).","['392 participants, with 196 participants in each group', 'patients with polycystic ovary syndrome who are participating in an IVF programme', 'Women with polycystic ovary syndrome (PCOS) undergoing in vitro fertilization (IVF) protocols', 'Patients with PCOS', 'patients with PCOS who are undergoing IVF procedures']","['flexible gonadotropin-releasing hormone (GnRH) antagonist protocol', 'controlled ovarian stimulation regimens-GnRH antagonist or PPOS-using a computer-generated random number', 'progestin-primed ovarian stimulation protocol', 'flexible GnRH antagonist protocol', 'novel progestin-primed ovarian stimulation (PPOS) protocol']","['risk of developing ovarian hyperstimulation syndrome (OHSS', 'luteinising hormone (LH) surge', 'incidence of premature LH surges, the duration and total dose of human menopausal gonadotropin stimulation, the number of oocytes retrieved, the incidence of moderate or severe OHSS, the number of embryos available for transfer, implantation rates, clinical pregnancy rates, pregnancy loss rates, ectopic pregnancy rates, pregnancy and neonatal complications, and congenital anomalies', 'live-birth rate per transfer']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025326', 'cui_str': 'human menopausal gonadotrophin'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0032987', 'cui_str': 'Ectopic pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.318829,"The oocytes are often of poor quality, leading to lower pregnancy rates, higher miscarriage rates and an increased risk of developing ovarian hyperstimulation syndrome (OHSS).","[{'ForeName': 'Ningling', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China sammy20080228@icloud.com.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': ""Department of Assisted Reproduction, Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.""}]",BMJ open,['10.1136/bmjopen-2020-038153']
2300,33268345,Corneal Transplant Follow-up Study II: a randomised trial to determine whether HLA class II matching reduces the risk of allograft rejection in penetrating keratoplasty.,"PURPOSE
A randomised trial to test the hypothesis that human leucocyte antigen (HLA) class II matching reduces the risk of allograft rejection in high-risk penetrating keratoplasty (PK).
METHODS
All transplants were matched for HLA class I antigens (≤2 mismatches at the A and B loci) and corneas were allocated to patients by cohort minimisation to achieve 0, 1 or 2 HLA class II antigen mismatches. The corneal transplants (n=1133) were followed for 5 years. The primary outcome measure was time to first rejection episode.
RESULTS
Cox regression analysis found no influence of HLA class II mismatching on risk of immunological rejection (HR 1.13; 95% CI 0.79 to 1.63; p=0.51). The risk of rejection in recipients older than 60 years was halved compared with recipients ≤40 years (HR 0.51; 95% CI 0.36 to 0.73; p=0.0003). Rejection was also more likely where cataract surgery had been performed after PK (HR 3.68; 95% CI 1.95 to 6.93; p<0.0001). In univariate analyses, preoperative factors including chronic glaucoma (p=0.02), vascularisation (p=0.01), inflammation (p=0.03), ocular surface disease (p=0.0007) and regrafts (p<0.001) all increased the risk of rejection. In the Cox model, however, none of these factors was individually significant but rejection was more likely where≥2 preoperative risk factors were present (HR 2.11; 95% CI 1.26 to 3.47; p<0.003).
CONCLUSIONS
HLA class II matching, against a background of HLA class I matching, did not reduce the risk of allograft rejection. Younger recipient age, the presence of ≥2 preoperative risk factors and cataract surgery after PK all markedly increased the risk of allograft rejection.
TRIAL REGISTRATION NUMBER
ISRCTN25094892.",2020,"In univariate analyses, preoperative factors including chronic glaucoma (p=0.02), vascularisation (p=0.01), inflammation (p=0.03), ocular surface disease (p=0.0007) and regrafts (p<0.001) all increased the risk of rejection.","['All transplants were matched for HLA class', 'high-risk penetrating keratoplasty (PK', 'penetrating keratoplasty']","['HLA class II matching', 'human leucocyte antigen (HLA) class II matching']","['time to first rejection episode', 'inflammation', 'HLA class II mismatching on risk of immunological rejection', 'chronic glaucoma', 'Rejection', 'ocular surface disease', 'risk of allograft rejection', 'risk of rejection']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0019721', 'cui_str': 'HLA antigen'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022592', 'cui_str': 'Penetrating keratoplasty'}]","[{'cui': 'C0019721', 'cui_str': 'HLA antigen'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019721', 'cui_str': 'HLA antigen'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}]",1133.0,0.0415715,"In univariate analyses, preoperative factors including chronic glaucoma (p=0.02), vascularisation (p=0.01), inflammation (p=0.03), ocular surface disease (p=0.0007) and regrafts (p<0.001) all increased the risk of rejection.","[{'ForeName': 'W John', 'Initials': 'WJ', 'LastName': 'Armitage', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom w.j.armitage@bristol.ac.uk.'}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'Winton', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Mark N A', 'Initials': 'MNA', 'LastName': 'Jones', 'Affiliation': 'NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Downward', 'Affiliation': 'NHS Blood and Transplant, Bristol, United Kingdom.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Crewe', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Derek M', 'Initials': 'DM', 'LastName': 'Tole', 'Affiliation': 'Bristol Eye Hospital, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Dick', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}]",The British journal of ophthalmology,['10.1136/bjophthalmol-2020-317543']
2301,33268341,The effect of tiotropium/olodaterol versus fluticasone propionate/salmeterol on left ventricular filling and lung hyperinflation in patients with COPD.,"This exploratory, randomised, double-blind, double-dummy, multicentre, cross-over study explored the effect of 6 weeks of treatment with tiotropium/olodaterol (T/O) versus fluticasone propionate/salmeterol (F/S) on left ventricular filling in patients with chronic obstructive pulmonary disease with functional residual capacity (FRC) >120% predicted and postbronchodilator improvement of FRC ≥7.5%. Overall, 76 patients were randomised across nine sites. Treatment with T/O or F/S increased left ventricular end-diastolic volume index from baseline (adjusted mean change: T/O: 2.317 mL/m 2 , F/S: 2.855 mL/m 2 ), with no statistically significant difference between treatments. However, T/O resulted in a significantly greater reduction in lung hyperinflation versus F/S (FRC plethysmography absolute change from baseline: F/S: -0.329 L, T/O: -0.581 L).",2020,"However, T/O resulted in a significantly greater reduction in lung hyperinflation versus F/S (FRC plethysmography absolute change from baseline: F/S: -0.329","['patients with chronic obstructive pulmonary disease with functional residual capacity (FRC) >120% predicted and postbronchodilator improvement of FRC ≥7.5', 'patients with COPD', '76 patients were randomised across nine sites']","['tiotropium/olodaterol (T/O) versus fluticasone propionate/salmeterol (F/S', 'tiotropium/olodaterol versus fluticasone propionate/salmeterol']","['lung hyperinflation versus F/S (FRC plethysmography absolute change', 'left ventricular filling and lung hyperinflation', 'left ventricular end-diastolic volume index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0016815', 'cui_str': 'Functional residual capacity'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}]","[{'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0016815', 'cui_str': 'Functional residual capacity'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0042509', 'cui_str': 'Ventricular End-Diastolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",76.0,0.602626,"However, T/O resulted in a significantly greater reduction in lung hyperinflation versus F/S (FRC plethysmography absolute change from baseline: F/S: -0.329","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Herth', 'Affiliation': 'Department of Pneumology and Critical Care Medicine, Thoraxklinik-Heidelberg GmbH, Translational Lung Research Center Heidelberg (TLRC), Heidelberg, Germany felix.herth@med.uni-heidelberg.de.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Hohlfeld', 'Affiliation': 'Biomedical Research in Endstage and Obstructive Lung Disease (BREATH), Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, Hannover, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Haas', 'Affiliation': 'CIMS Studienzentrum Bamberg GmbH, Bamberg, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'TA CardioMetabolism Respiratory Medicine, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Xidong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, USA.'}, {'ForeName': 'Karl-Friedrich', 'Initials': 'KF', 'LastName': 'Kreitner', 'Affiliation': 'Department of Radiology, Johannes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Marburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Vogel-Claussen', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Watz', 'Affiliation': 'Pulmonary Research Institute, LungenClinic Grosshansdorf GmbH, Airway Research Centre North (ARCN), Grosshansdorf, Germany.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000741']
2302,33268325,"Duration of safe apnea in patients with morbid obesity during passive oxygenation using high-flow nasal insufflation versus regular flow nasal insufflation, a randomized trial.","BACKGROUND
Obese patients are at risk for rapid oxygen desaturation during anesthesia induction. Apneic oxygenation with regular flow oxygen insufflation has successfully been used to prolong the duration of safe apnea without desaturation (DAWD) in morbidly obese patients. Using high-flown nasal insufflation of oxygen (HFNI) for apneic oxygenation might further increase the DAWD.
OBJECTIVES
To compare the duration of safe apnea using high-flown nasal insufflation of oxygen or standard flow oxygen insufflation for apneic oxygenation in a simulated difficult intubation scenario in patients with morbid obesity.
SETTING
Operating room, University Hospital, Austria.
METHODS
In a prospective, randomized, clinical trial, patients received standardized preoxygenation and anesthesia induction. Apneic oxygenation was performed using standard nasal prongs (10 L/min) or HFNI (120 L/min) during laryngoscopy. A Cormack-Lehane 3° view was maintained until the oxygen saturation on pulse oximetry (SpO 2 ) dropped ≤95% or for a maximum of 15 minutes. The primary outcome of this study was to compare the duration of safe apnea using HFNI or standard flow oxygen insufflation for apneic oxygenation. In addition, arterial blood gas results, and airway pressures were investigated.
RESULTS
In 40 patients with morbid obesity (body mass index [BMI] >40 kg/m 2 ) and the American Society of Anesthesiologists physical classification ≤3 who underwent bariatric surgery, the median duration of safe apnea was 601 (268-900) seconds in the standard group and 537 (399-808) seconds in the HFNI group (P = .698). No differences in arterial blood gas results were observed between the groups. The median airway pressure was 0 (0-0) cm H 2 O in the standard group and 1 (0-2) cm H 2 O in the HFNI group (P = .005).
CONCLUSION
Compared with standard nasal apneic oxygenation, HFNI did not increase the duration of safe apnea in patients with morbid obesity. A significant but clinically negligible higher airway pressure was observed when using HFNI.",2020,"Compared with standard nasal apneic oxygenation, HFNI did not increase the duration of safe apnea in patients with morbid obesity.","['patients with morbid obesity', 'Operating room, University Hospital, Austria', 'patients with morbid obesity during', '40 patients with morbid obesity (body mass index [BMI] >40 kg/m 2 ) and the American Society of Anesthesiologists physical classification ≤3 who underwent bariatric surgery, the median duration of safe apnea was 601 (268-900) seconds in the standard group and 537 (399-808) seconds in the HFNI group (P = .698', 'morbidly obese patients', 'Obese patients']","['HFNI', 'Apneic oxygenation with regular flow oxygen insufflation', 'high-flown nasal insufflation of oxygen (HFNI', 'standard nasal apneic oxygenation, HFNI', 'oxygen or standard flow oxygen insufflation', 'passive oxygenation using high-flow nasal insufflation versus regular flow nasal insufflation', 'standardized preoxygenation and anesthesia induction']","['duration of safe apnea', 'duration of safe apnea using HFNI or standard flow oxygen insufflation for apneic oxygenation', 'Duration of safe apnea', 'airway pressure', 'arterial blood gas results, and airway pressures', 'arterial blood gas results', 'median airway pressure', 'Apneic oxygenation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012578', 'cui_str': 'Order Diptera'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012578', 'cui_str': 'Order Diptera'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0475745', 'cui_str': 'Apneic oxygenation'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0412792', 'cui_str': 'Preoxygenation'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012578', 'cui_str': 'Order Diptera'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0475745', 'cui_str': 'Apneic oxygenation'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",40.0,0.059703,"Compared with standard nasal apneic oxygenation, HFNI did not increase the duration of safe apnea in patients with morbid obesity.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamp', 'Affiliation': 'Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Division of General Anesthesia and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: thomas.hamp@meduniwien.ac.at.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Prager', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Baron-Stefaniak', 'Affiliation': 'Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Division of General Anesthesia and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Müller', 'Affiliation': 'Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Division of General Anesthesia and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bichler', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Plöchl', 'Affiliation': 'Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Division of General Anesthesia and Intensive Care Medicine, Medical University of Vienna, Vienna, Austria.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.09.027']
2303,33268222,Effects of Local Warming on the Peripheral Vein Cross-Sectional Area in Children Under Sedation.,"PURPOSE
Peripheral venous catheterization is challenging in small children. The local warming technique has been used to increase the peripheral vein cross-sectional area (CSA) and improve the success rate. However, there is limited evidence on the effect of local warming on venous CSA in children under sedation.
DESIGN
A pilot randomized controlled trial.
METHODS
Eligible children aged 1 to 4 years undergoing ambulatory surgery were enrolled. At the bedside in the ambulatory surgery center, they were routinely sedated with 1 mcg/kg of intranasal dexmedetomidine. Through a computer allocation program, children were randomized into either a control group or a local warming group. Cephalic vein and basilic vein at 1 cm proximal to cubital fossa were scanned with ultrasound to measure venous CSA. Children in the control group received no intervention; those in the local warming group had a prepared hot pack of ~40°C applied to the target area on the arm for 5 minutes. A second ultrasound measurement was undertaken in both groups.
FINDINGS
A total of 35 from 40 children were analyzed. Cephalic vein CSA and basilic vein CSA increased significantly vs the first measurement within the local warming group (P < .05 for both) but not in the control group (P > .05 for both). Cephalic vein CSA was significantly different between groups at the second measurement (P < .05) but not at the first measurement (P > .05). Basilic vein CSA was significantly different between groups neither at the first measurement nor at the second measurement (P > .05 for both). The application of local warming resulted in an average of 34% increase (from 4.1 to 5.5 mm 2 ) in cephalic vein CSA and an average of 21% increase (from 4.8 to 5.8 mm 2 ) in basilic vein CSA.
CONCLUSIONS
The application of local warming induced mild venodilation in cephalic vein with an increase in CSA by 34% and had little venodilation effect on the basilic vein with an increase in CSA by only 21%.",2020,Cephalic vein CSA was significantly different between groups at the second measurement (P < .05) but not at the first measurement (P > .05).,"['A total of 35 from 40 children', 'small children', 'Children Under Sedation', 'Eligible children aged 1 to 4\xa0years undergoing ambulatory surgery were enrolled', 'children under sedation']","['Local Warming', 'dexmedetomidine', 'Peripheral venous catheterization', 'local warming group had a prepared hot pack of ~40', 'Cephalic vein and basilic vein at 1\xa0cm proximal to cubital fossa were scanned with ultrasound to measure venous CSA', 'control group or a local warming group']","['Basilic vein CSA', 'Cephalic vein CSA', 'Cephalic vein CSA and basilic vein CSA', 'Peripheral Vein Cross-Sectional Area']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0031127', 'cui_str': 'Catheterization, Peripheral Venous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0226801', 'cui_str': 'Structure of basilic vein'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0230349', 'cui_str': 'Structure of cubital fossa'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0226801', 'cui_str': 'Structure of basilic vein'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0226802', 'cui_str': 'Structure of cephalic vein'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",40.0,0.0254989,Cephalic vein CSA was significantly different between groups at the second measurement (P < .05) but not at the first measurement (P > .05).,"[{'ForeName': 'Meili', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Nursing Department, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Anesthesia Department, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Anesthesia Department, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Xinyan', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Anesthesia Department, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Shoudong', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'Anesthesia Department, Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Anesthesia Department, Capital Institute of Pediatrics, Beijing, China. Electronic address: hanyapeng2009@126.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.06.027']
2304,33268143,"Impact of specialized oral nutritional supplement on clinical, nutritional, and functional outcomes: A randomized, placebo-controlled trial in community-dwelling older adults at risk of malnutrition.","BACKGROUND & AIMS
The world's over-65 population is expanding rapidly, and the risk of malnutrition is prevalent in this population. Meeting nutritional needs is a recognized strategy to reduce and address multiple debilitating adverse health outcomes associated with malnutrition. The objective of this randomized, controlled trial was to determine the effects of oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HMB), along with dietary counseling, on health outcomes in community-dwelling older adults at risk of malnutrition.
METHODS
Strengthening Health In ELDerly through nutrition (SHIELD) studied adults aged ≥ 65 years in Singapore who were recruited between August 2017 and March 2019. Participants were community ambulant and classified as medium or high risk for malnutrition using Malnutrition Universal Screening Tool (MUST). Participants (n = 811) were randomly assigned to one of two study treatments for 180 days: (i) two servings/day of ONS containing HMB with dietary counseling (n = 405) or (ii) two servings/day of placebo supplement with dietary counseling (n = 406). The primary composite outcome was 'survival without hospital (re)admission and with at least 5% weight gain to day 180'. Dietary intakes, nutritional and functional outcomes were measured at baseline, 30, 90, and 180 days.
RESULTS
A higher proportion in intervention group met the 180-day primary composite outcome compared to placebo (33.4% vs. 8.7%, P < 0.001), largely driven by body weight component (36.2% vs. 9.4%, P < 0.001). Survival and hospital (re)admission rate were not significantly different between the groups. Weight, BMI, and mid upper arm circumference were significantly greater in the intervention group compared to placebo during the study (all P < 0.001), and at days 30, 90, and 180 (all P < 0.05). The odds of having better nutritional status during the study were also significantly higher in the intervention group compared to placebo, as measured using MUST risk (OR = 2.68, P < 0.001) and vitamin D status (OR = 4.23, P < 0.001). Intervention group had significantly higher energy, protein, fat, and carbohydrate intakes than the placebo group (all P ≤ 0.017). Leg strength at day 90 was significantly greater for the intervention group than for the placebo group (LSM ± SE: 12.85 ± 0.22 vs. 12.17 ± 0.22; P = 0.030). Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± 0.17 vs. 13.70 ± 0.17; P = 0.048). Within the low appendicular skeletal muscle mass index (ASMI) subgroup, the intervention group had significantly greater calf circumference at days 90 and 180 compared to placebo (both P ≤ 0.0289).
CONCLUSIONS
For community-dwelling older adults at risk of malnutrition, daily consumption of specialized ONS containing HMB and vitamin D for six months, along with dietary counseling, significantly improved nutritional and functional outcomes compared to placebo supplement with dietary counseling.
CLINICAL TRIAL REGISTRATION
www.ClinicalTrials.govNCT03245047.",2020,Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± ,"['Participants (n\xa0', 'In ELDerly through nutrition (SHIELD) studied adults aged\xa0≥\xa065 years in Singapore who were recruited between August 2017 and March 2019', 'Strengthening Health', '811', 'community-dwelling older adults at risk of malnutrition', 'Participants were community ambulant and classified as medium or high risk for malnutrition using Malnutrition Universal Screening Tool (MUST']","['oral nutritional supplement (ONS) containing beta-hydroxy-beta-methylbutyrate (HMB', 'placebo', 'ONS containing HMB with dietary counseling', 'specialized oral nutritional supplement', 'dietary counseling', 'placebo supplement with dietary counseling']","['Handgrip strength for females', 'Weight, BMI, and mid upper arm circumference', 'nutritional and functional outcomes', 'survival without hospital (re)admission and with at least 5% weight gain to day 180', 'body weight component', 'vitamin D status ', 'calf circumference', 'higher energy, protein, fat, and carbohydrate intakes', 'Leg strength', 'Survival and hospital (re)admission rate', 'clinical, nutritional, and functional outcomes', 'Dietary intakes, nutritional and functional outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1532006', 'cui_str': 'Malnutrition universal screening tool'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0053454', 'cui_str': '3-hydroxyisovaleric acid'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0562351', 'cui_str': 'Mid upper arm circumference'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",811.0,0.338833,Handgrip strength for females was significantly higher at day 180 for the intervention group compared to placebo (LSM ± SE: 14.18 ± ,"[{'ForeName': 'Samuel Teong Huang', 'Initials': 'STH', 'LastName': 'Chew', 'Affiliation': 'Department of Geriatric Medicine, Changi General Hospital, Singapore; Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: samuel.chew.t.h@singhealth.com.sg.'}, {'ForeName': 'Ngiap Chuan', 'Initials': 'NC', 'LastName': 'Tan', 'Affiliation': 'SingHealth Polyclinics, Singapore; SingHealth-Duke NUS Family Medicine Academic Clinical Program, Singapore.'}, {'ForeName': 'Magdalin', 'Initials': 'M', 'LastName': 'Cheong', 'Affiliation': 'Department of Dietetic & Food Services, Changi General Hospital, Singapore.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'Abbott Nutrition Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Baggs', 'Affiliation': 'Abbott Nutrition Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Choe', 'Affiliation': 'Abbott Nutrition Research and Development, Columbus, OH, USA.'}, {'ForeName': 'Choon How', 'Initials': 'CH', 'LastName': 'How', 'Affiliation': 'SingHealth-Duke NUS Family Medicine Academic Clinical Program, Singapore; Care and Health Integration, Changi General Hospital, Singapore.'}, {'ForeName': 'Wai Leng', 'Initials': 'WL', 'LastName': 'Chow', 'Affiliation': 'Health Services Research, Changi General Hospital, Singapore.'}, {'ForeName': 'Cynthia Yan Ling', 'Initials': 'CYL', 'LastName': 'Tan', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Shuyi Charmaine', 'Initials': 'SC', 'LastName': 'Kwan', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Farah Safdar', 'Initials': 'FS', 'LastName': 'Husain', 'Affiliation': 'SingHealth Polyclinics, Singapore.'}, {'ForeName': 'Yen Ling', 'Initials': 'YL', 'LastName': 'Low', 'Affiliation': 'Abbott Nutrition Research and Development, Asia-Pacific Center, Singapore.'}, {'ForeName': 'Dieu Thi Thu', 'Initials': 'DTT', 'LastName': 'Huynh', 'Affiliation': 'Abbott Nutrition Research and Development, Asia-Pacific Center, Singapore.'}, {'ForeName': 'Siew Ling', 'Initials': 'SL', 'LastName': 'Tey', 'Affiliation': 'Abbott Nutrition Research and Development, Asia-Pacific Center, Singapore.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.10.015']
2305,33268022,Effect of Older vs Younger Age on Anthropometric and Metabolic Variables During Treatment of Psychotic Depression With Sertraline Plus Olanzapine: The STOP-PD II Study.,"OBJECTIVE
To examine the effect of older versus younger age on change in anthropometric and metabolic measures during extended treatment of psychotic depression with sertraline plus olanzapine.
METHODS
Two hundred and sixty-nine men and women aged 18-85 years with an episode of psychotic depression were treated with open-label sertraline plus olanzapine for up to 12 weeks. Participants who remained in remission following an 8-week stabilization phase were eligible to participate in a 36-week randomized controlled trial (RCT) that compared the efficacy and tolerability of sertraline plus olanzapine with sertraline plus placebo. Weight, waist circumference and plasma lipids, glucose, HbA1c, and insulin were measured at regular intervals during the acute, stabilization and randomized phases of the study. Linear mixed models were used to analyze the trajectories of anthropometric and metabolic measures.
RESULTS
Participants aged 60 years or older experienced less weight gain and less increase in cholesterol during the combined acute and stabilization phases of the study compared with those aged 18-59 years. At the acute-stabilization termination visit, mean weight in older participants was 6.5 lb. less than premorbid weight, whereas it was 17.9 lb. more than premorbid weight in younger participants. In the RCT, there was a significant interaction of treatment and age group for the trajectory of weight, but the post hoc tests that compared age groups within each treatment arm were not statistically significant. There were no clinically significant differences between younger and older participants in glycemic measures.
CONCLUSION
Older patients with psychotic depression experienced less increase in weight and total cholesterol than their younger counterparts during acute and stabilization treatment with sertraline plus olanzapine. In the older group, weight gained during the acute and stabilization phases appeared to be partial restoration of weight lost during the index episode of depression, whereas weight gain in younger participants was not.",2020,Older patients with psychotic depression experienced less increase in weight and total cholesterol than their younger counterparts during acute and stabilization treatment with sertraline plus olanzapine.,"['Two hundred and sixty-nine men and women aged 18-85 years with an episode of psychotic depression', 'Participants aged 60 years or older experienced less', 'Participants who remained in remission following an 8-week stabilization phase were eligible to participate', 'Older patients with psychotic depression']","['sertraline plus olanzapine', 'open-label sertraline plus olanzapine', 'sertraline plus olanzapine with sertraline plus placebo', 'Sertraline Plus Olanzapine']","['weight and total cholesterol', 'Weight, waist circumference and plasma lipids, glucose, HbA1c, and insulin', 'efficacy and tolerability', 'glycemic measures', 'cholesterol', 'weight gain', 'Anthropometric and Metabolic Variables']","[{'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0270458', 'cui_str': 'Severe major depression with psychotic features'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",269.0,0.067688,Older patients with psychotic depression experienced less increase in weight and total cholesterol than their younger counterparts during acute and stabilization treatment with sertraline plus olanzapine.,"[{'ForeName': 'Alastair J', 'Initials': 'AJ', 'LastName': 'Flint', 'Affiliation': 'Department of Psychiatry (AJF, BHM, ANV), University of Toronto, ON, Canada; Centre for Mental Health, University Health Network (AJF), Toronto, ON, Canada. Electronic address: alastair.flint@uhn.ca.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Health Care (AJR), Worcester, MA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Whyte', 'Affiliation': 'Department of Psychiatry (EMW), UPMC Western Psychiatric Hospital, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry (GSA, PM, CDP, BSM)), Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital, Westchester Division, NY.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry (AJF, BHM, ANV), University of Toronto, ON, Canada; Centre for Addiction and Mental Health (BHM, ANV), Toronto, ON, Canada.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marino', 'Affiliation': 'Department of Psychiatry (GSA, PM, CDP, BSM)), Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital, Westchester Division, NY.'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Healthcare Policy and Research (SB, YW), Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Cristina D', 'Initials': 'CD', 'LastName': 'Pollari', 'Affiliation': 'Department of Psychiatry (GSA, PM, CDP, BSM)), Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital, Westchester Division, NY.'}, {'ForeName': 'Yiyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Healthcare Policy and Research (SB, YW), Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Aristotle N', 'Initials': 'AN', 'LastName': 'Voineskos', 'Affiliation': 'Department of Psychiatry (AJF, BHM, ANV), University of Toronto, ON, Canada; Centre for Addiction and Mental Health (BHM, ANV), Toronto, ON, Canada.'}, {'ForeName': 'Barnett S', 'Initials': 'BS', 'LastName': 'Meyers', 'Affiliation': 'Department of Psychiatry (GSA, PM, CDP, BSM)), Weill Cornell Medicine of Cornell University and New York Presbyterian Hospital, Westchester Division, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.11.003']
2306,33268020,An association between resting state EEG parameters and the severity of topiramate-related cognitive impairment.,"INTRODUCTION
Many commonly prescribed drugs cause cognitive deficits. We investigated whether parameters of the resting-state electroencephalogram (rsEEG) are related to the severity of cognitive impairments associated with administration of the antiseizure drug topiramate (TPM) and the benzodiazepine lorazepam (LZP).
METHODS
We conducted a double-blind, randomized, placebo-controlled crossover study. After a baseline visit, subjects completed three sessions at which they received either a single dose of TPM, LZP, or placebo. Four-hours after drug administration and at baseline, subjects completed a working memory (WM) task after their rsEEG was recorded. After quantifying drug-related behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change for each subject, we constructed drug-specific mixed effects models of change for each WM and EEG measure. Regression models were constructed to characterize the relationship between baseline rsEEG measures and drug-related performance changes.
RESULTS
Linear mixed effects models showed theta power increases in response to TPM administration. The results of the regression models revealed a number of robust relationships between baseline rsEEG parameters and TPM-related, but not LZP-related, WM impairment.
CONCLUSIONS
We showed for the first time that parameters of the rsEEG are associated with the severity of TPM-related WM deficits; this suggests that rsEEG measures may have novel clinical applications in the future.",2020,"After quantifying drug-related behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change for each subject, we constructed drug-specific mixed effects models of change for each WM and EEG measure.",[],"['benzodiazepine lorazepam (LZP', 'TPM, LZP, or placebo', 'antiseizure drug topiramate (TPM', 'placebo']","['behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change']",[],"[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.102604,"After quantifying drug-related behavioral (WM accuracy (ACC)/reaction time (RT)) and electrophysiological (alpha, theta, beta (1,2), gamma power) change for each subject, we constructed drug-specific mixed effects models of change for each WM and EEG measure.","[{'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Barkley', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: barkl025@umn.edu.'}, {'ForeName': 'Zhenhong', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Biomedical Engineering, University of Florida, 1275 Center Drive, Gainesville, FL 32611, United States.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Fieberg', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 429 Delaware Street SE, Minneapolis, MN 55455, United States. Electronic address: afieberg@umn.edu.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Eberly', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 429 Delaware Street SE, Minneapolis, MN 55455, United States. Electronic address: leberly@umn.edu.'}, {'ForeName': 'Angela K', 'Initials': 'AK', 'LastName': 'Birnbaum', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: birnb002@umn.edu.'}, {'ForeName': 'Ilo E', 'Initials': 'IE', 'LastName': 'Leppik', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: leppi001@umn.edu.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Marino', 'Affiliation': 'Center for Clinical and Cognitive Neuropharmacology, Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, 308 Harvard Street, Minneapolis, MN 55455, United States. Electronic address: marin007@umn.edu.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107598']
2307,33267966,Attitudes are associated with the drug use profiles of middle school adolescents: A latent class analysis.,"The association between positive and negative attitudes and drug use profiles is examined. Participants were public middle school students (N = 5213; 49.9% girls; M age= 13.2 years) in three Brazilian cities. Analysis was performed using baseline surveys of a randomized controlled trial of the #Tamojunto2.0 drug use prevention program. We validated the attitudes construct via a confirmatory factor analysis and performed a simultaneous multinomial regression with a latent class analysis. Three latent classes were identified: abstainers/low users (ABS) (63.4%), alcohol users/binge drinkers (ALC) (29.5%), and polydrug users (POL) (7.1%). An association gradient was found between attitudes and latent classes. Using ABS as reference, a direct association was identified between positive attitudes and ALC and POL. An inverse association was found between negative attitudes and POL only. Girls and older students were more likely to be ALC and POL. These findings, from a large probabilistic sample, provide guidance that drug use prevention programs should focus on deconstructing positive attitudes -mainly- and broadening negative attitudes, and should adapt their thematic content by considering the differential drug use possibilities among girls and older students.",2020,"Three latent classes were identified: abstainers/low users (ABS) (63.4%), alcohol users/binge drinkers (ALC) (29.5%), and polydrug users (POL) (7.1%).","['girls and older students', '49.9% girls; M age= 13.2 years) in three Brazilian cities', 'middle school adolescents', 'Girls and older students', 'Three latent classes were identified: abstainers/low users (ABS) (63.4%), alcohol users/binge drinkers (ALC) (29.5%), and polydrug users (POL) (7.1', 'Participants were public middle school students (N\xa0=\xa05213']",[],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0556297', 'cui_str': 'Current drinker'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker'}]",[],[],,0.0141626,"Three latent classes were identified: abstainers/low users (ABS) (63.4%), alcohol users/binge drinkers (ALC) (29.5%), and polydrug users (POL) (7.1%).","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Garcia-Cerde', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, Rua Botucatu, 740, Bairro Vila Clementino. São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana Y', 'Initials': 'JY', 'LastName': 'Valente', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, Rua Botucatu, 740, Bairro Vila Clementino. São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, Rua Botucatu, 740, Bairro Vila Clementino. São Paulo, São Paulo, Brazil. Electronic address: zila.sanchez@unifesp.br.'}]",Psychiatry research,['10.1016/j.psychres.2020.113592']
2308,33267922,The utility of household Grocery Purchase Quality Index scores as an individual diet quality metric.,"The validated Grocery Purchase Quality Index (GPQI) reflects concordance between household grocery purchases and US dietary recommendations. However, it is unclear whether GPQI scores calculated from partial purchasing records validly reflect individual-level diet quality. Within the 9-month randomized controlled Smart Cart study examining the effect of targeted coupons on grocery purchase quality (n=209), this secondary analysis examined concordance between the GPQI (range 0-75, scaled to 100) calculated from 3-months of loyalty-card linked partial (≥50%) household grocery purchasing data and individual-level Healthy Eating Index (HEI) scores at baseline and 3-months calculated from food frequency questionnaires. HEI and GPQI concordance was assessed with overall and demographic-stratified partially-adjusted correlations; covariate-adjusted percent score differences, cross-classification, and weighted kappa coefficients assessed concordance across GPQI tertiles (T). Participants were mostly middle-aged (55.4(13.9) years), female (90.3%), from non-smoking households (96.4%), without children (70.7%). Mean GPQI (54.8(9.1)%) scores were lower than HEI scores (baseline: 73.2(9.1)%, 3-months: 72.4(9.4)%), and moderately correlated (baseline r=0.41 vs. 3-month r=0.31, p<0.001). Correlations were stronger among participants with ≤ bachelor's degree, obesity, and children. Concordance was highest in T3. Participants with high (T3) vs. low (T1) GPQI scores had 7.3-10.6 higher odds of having HEI scores >80% at both timepoints. Weighted kappas (k=0.25) indicated moderate agreement between scores. Household-level GPQI derived from partial grocery purchasing data were moderately correlated with self-reported intake, indicating their promise for evaluating diet quality. Partial purchasing data appears to moderately reflect individual diet quality and may be useful in interventions monitoring changes in diet quality.",2020,"Mean GPQI (54.8(9.1)%) scores were lower than HEI scores (baseline: 73.2(9.1)%, 3-months: 72.4(9.4)%), and moderately correlated (baseline r=0.41 vs. 3-month r=0.31, p<0.001).","['Participants were mostly middle-aged (55.4(13.9) years), female (90.3%), from non-smoking households (96.4%), without children (70.7']",[],"['grocery purchasing data and individual-level Healthy Eating Index', 'grocery purchase quality', 'Mean GPQI (54.8(9.1)%) scores', 'HEI) scores', 'HEI and GPQI concordance']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0390455,"Mean GPQI (54.8(9.1)%) scores were lower than HEI scores (baseline: 73.2(9.1)%, 3-months: 72.4(9.4)%), and moderately correlated (baseline r=0.41 vs. 3-month r=0.31, p<0.001).","[{'ForeName': 'Haley Wynne', 'Initials': 'HW', 'LastName': 'Parker', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island; 41 Lower College Rd, Kingston, RI02881.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'de Araujo', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island; 41 Lower College Rd, Kingston, RI02881.'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Massachusetts General Hospital, 100 Cambridge St, Boston, MA, 02114; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Vadiveloo', 'Affiliation': 'Department of Nutrition and Food Sciences, University of Rhode Island; 41 Lower College Rd, Kingston, RI02881.'}]",The British journal of nutrition,['10.1017/S0007114520004833']
2309,33267919,Enhanced cognitive-behavior therapy and family-based treatment for adolescents with an eating disorder: a non-randomized effectiveness trial.,"BACKGROUND
Family-based treatment (FBT) is an efficacious intervention for adolescents with an eating disorder. Evaluated to a lesser degree among adolescents, enhanced cognitive-behavior therapy (CBT-E) has shown promising results. This study compared the relative effectiveness of FBT and CBT-E, and as per manualized CBT-E, the sample was divided into a lower weight [<90% median body mass index (mBMI)], and higher weight cohort (⩾90%mBMI).
METHOD
Participants (N = 97) aged 12-18 years, with a DSM-5 eating disorder diagnosis (largely restrictive, excluding Avoidant Restrictive Food Intake Disorder), and their parents, chose between FBT and CBT-E. Assessments were administered at baseline, end-of-treatment (EOT), and follow-up (6 and 12 months). Treatment comprised of 20 sessions over 6 months, except for the lower weight cohort where CBT-E comprised 40 sessions over 9-12 months. Primary outcomes were slope of weight gain and change in Eating Disorder Examination (EDE) Global Score at EOT.
RESULTS
Slope of weight gain at EOT was significantly higher for FBT than for CBT-E (lower weight, est. = 0.597, s.e. = 0.096, p < 0.001; higher weight, est. = 0.495, s.e. = 0.83, p < 0.001), but not at follow-up. There were no differences in the EDE Global Score or most secondary outcome measures at any time-point. Several baseline variables emerged as potential treatment effect moderators at EOT. Choosing between FBT and CBT-E resulted in older and less well participants opting for CBT-E.
CONCLUSIONS
Results underscore the efficiency of FBT to facilitate weight gain among underweight adolescents. FBT and CBT-E achieved similar outcomes in other domains assessed, making CBT-E a viable treatment for adolescents with an eating disorder.
CLINICAL TRIAL REGISTRATION INFORMATION
Treatment Outcome in Eating Disorders; https://clinicaltrials.gov/; NCT03599921.",2020,"FBT and CBT-E achieved similar outcomes in other domains assessed, making CBT-E a viable treatment for adolescents with an eating disorder.
","['Eating Disorders', 'underweight adolescents', 'adolescents with an eating disorder', 'Participants (N = 97) aged 12-18 years, with a DSM-5 eating disorder diagnosis (largely restrictive, excluding Avoidant Restrictive Food Intake Disorder']","['Family-based treatment (FBT', 'cognitive-behavior therapy and family-based treatment', 'FBT']","['EDE Global Score', 'slope of weight gain and change in Eating Disorder Examination (EDE) Global Score at EOT', 'weight gain at EOT']","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C2959762', 'cui_str': 'Eating disorder examination questionnaire global score'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",97.0,0.192685,"FBT and CBT-E achieved similar outcomes in other domains assessed, making CBT-E a viable treatment for adolescents with an eating disorder.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Eckhardt', 'Affiliation': ""Children's Minnesota, Minneapolis, St. Paul, MN, USA.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Dalle Grave', 'Affiliation': 'Villa Garda Hospital, Garda, Verona, Italy.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Sanford Center for Biobehavioral Research, Sanford Health, Fargo, ND, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Keery', 'Affiliation': ""Children's Minnesota, Minneapolis, St. Paul, MN, USA.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lesser', 'Affiliation': 'Rogers Behavioral Health, Minneapolis, MN, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Martell', 'Affiliation': ""Children's Minnesota, Minneapolis, St. Paul, MN, USA.""}]",Psychological medicine,['10.1017/S0033291720004407']
2310,33267876,Correction to: One Plus One Equals Two-will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],[],['severe perineal trauma'],[],[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]",,0.182736,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Edqvist', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden. malin.edqvist@med.lu.se.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Dahlen', 'Affiliation': 'School of Nursing and Midwifery, Western Sydney University, Sydney, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Häggsgård', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tern', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Ängeby', 'Affiliation': 'Centre for Clinical Research and Education, Region Värmland, Karlstad, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tegerstedt', 'Affiliation': 'Department of Obstetrics and Gynaecology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Teleman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ajne', 'Affiliation': 'Department of Obstetrics and Gynaecology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rubertsson', 'Affiliation': 'Department of Health Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}]",Trials,['10.1186/s13063-020-04936-5']
2311,33267860,Acceptability of a feasibility randomized clinical trial of a microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices (EMERGE) in young adults: a mixed methods assessment.,"BACKGROUND
Acceptability is a critical requisite in establishing feasibility when planning a larger effectiveness trial. This study assessed the acceptability of conducting a feasibility randomized clinical trial of a 20-week microenterprise intervention for economically-vulnerable African-American young adults, aged 18 to 24, in Baltimore, Maryland. Engaging MicroenterprisE for Resource Generation and Health Empowerment (EMERGE) aimed to reduce sexual risk behaviors and increase employment and uptake of HIV preventive behaviors.
METHODS
Thirty-eight participants were randomized to experimental (n = 19) or comparison group (n = 19). The experimental group received text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages. The comparison group received text messages on job openings only. Qualitative and quantitative post-intervention, in-person interviews were used in addition to process documentation of study methods.
RESULTS
Our results found that the study design and interventions showed promise for being acceptable to economically-vulnerable African-American young adults. The largely positive endorsement suggested that factors contributing to acceptability included perceived economic potential, sexual health education, convenience, incentives, and encouraging, personalized feedback to participants. Barriers to acceptability for some participants included low cell phone connectivity, perceived payment delays, small cohort size, and disappointment with one's randomization assignment to comparison group. Use of peer referral, network, or wait-list designs, in addition to online options may enhance acceptability in a future definitive trial. Expanding administrative and mentoring support may improve overall experience.
CONCLUSION
Microenterprise interventions are acceptable ways of providing young adults with important financial and sexual health content to address HIV risks associated with economic vulnerability.
TRIAL REGISTRATION
ClinicalTrials.gov. NCT03766165 . Registered 04 December 2018.",2020,Our results found that the study design and interventions showed promise for being acceptable to economically-vulnerable African-American young adults.,"['Thirty-eight participants', 'young adults', 'economically-vulnerable African-American young adults, aged 18 to 24, in Baltimore, Maryland', 'African-American young adults']","['microenterprise intervention', 'Microenterprise interventions', 'text messages on job openings plus educational sessions, mentoring, a start-up grant, and business and HIV prevention text messages', 'text messages on job openings only']",['sexual risk behaviors'],"[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}]","[{'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0085936', 'cui_str': 'Business'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",38.0,0.137701,Our results found that the study design and interventions showed promise for being acceptable to economically-vulnerable African-American young adults.,"[{'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings Mayo-Wilson', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health, 1025 E. 7th Street, Bloomington, IN, 47405, USA. ljmayowi@iu.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Coleman', 'Affiliation': 'Department of International Health, Johns Hopkins University School of Public Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Fatmata', 'Initials': 'F', 'LastName': 'Timbo', 'Affiliation': 'Department of International Health, Johns Hopkins University School of Public Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of International Health, Johns Hopkins University School of Public Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Torres Brown', 'Affiliation': 'HEBCAC Youth Opportunity (YO!) Program, Johns Hopkins University School of Medicine, 1212 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Butler', 'Affiliation': 'AIRS, Inc., Empire Homes of Maryland, Inc., City Steps, 1800 N Charles Street, 7th Floor, Baltimore, MD, USA.'}, {'ForeName': 'Donaldson F', 'Initials': 'DF', 'LastName': 'Conserve', 'Affiliation': 'Department of Health Promotion, Education, and Behavior, Arnold School of Public Health, University of South Carolina, 915 Green Street, Columbia, SC, 29208, USA.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Glass', 'Affiliation': 'Department of International Health, Johns Hopkins University School of Public Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}]",BMC public health,['10.1186/s12889-020-09904-x']
2312,33267837,Oral clonazepam versus lorazepam in the treatment of methamphetamine-poisoned children: a pilot clinical trial.,"OBJECTIVES
To evaluate the efficacy of oral clonazepam versus oral lorazepam following initial parenteral benzodiazepine administration to control methamphetamine-induced agitation in children.
METHODS
In a single-center clinical trial, intravenous diazepam (0.2 mg/Kg) was initially administered to all methamphetamine-poisoned pediatric patients to control their agitation, followed by a single dose of oral clonazepam (0.05 mg/Kg; n = 15) or oral lorazepam (0.05 mg/Kg; n = 15) to prevent relapse of toxicity.
RESULTS
The median age [IQR] (range) was 15 [10, 36] (6-144) months. The source of poisoning was methamphetamine exposure from oral ingestion in 23 (76.7%) and passive inhalation in 7 (23.3%) patients. The most common symptoms/signs were agitation (29; 96.7%), mydriatic pupils (26; 86.7%), and tachycardia (20; 66.6%). Two in each group (13.3%) needed re-administration of intravenous diazepam due to persistent agitation. There was no report of benzodiazepine complications in either group.
CONCLUSIONS
Clonazepam and lorazepam treatment was equally effective at similar doses. However, considering the higher potency of clonazepam, it seems that lorazepam is the safer benzodiazepine for oral maintenance treatment of methamphetamine-induced agitation in children and can be used with minimal complications.
TRIAL REGISTRATION
IRCT20180610040036N2, April 18th, 2020. Retrospectively registered.",2020,Two in each group (13.3%) needed re-administration of intravenous diazepam due to persistent agitation.,"['children', 'methamphetamine-poisoned children']","['methamphetamine-poisoned pediatric patients to control their agitation, followed by a single dose of oral clonazepam', 'Oral clonazepam versus lorazepam', 'Clonazepam and lorazepam', 'diazepam', 'benzodiazepine', 'lorazepam', 'clonazepam', 'oral lorazepam']","['median age [IQR', 'relapse of toxicity', 'benzodiazepine complications']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0032346', 'cui_str': 'Toxic substance'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0009011', 'cui_str': 'Clonazepam'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.113702,Two in each group (13.3%) needed re-administration of intravenous diazepam due to persistent agitation.,"[{'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Farnaghi', 'Affiliation': 'Department of Pediatrics, Loghman-Hakim Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Razieh', 'Initials': 'R', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pediatrics, Loghman-Hakim Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hassanian-Moghaddam', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. hassanian@sbmu.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Social Determinants of Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Narges', 'Initials': 'N', 'LastName': 'Gholami', 'Affiliation': 'Department of Pediatrics, Loghman-Hakim Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Latif', 'Initials': 'L', 'LastName': 'Gachkar', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",BMC pediatrics,['10.1186/s12887-020-02441-x']
2313,33267827,"Stakeholder perceptions of components of a Parkinson disease care management intervention, care coordination for health promotion and activities in Parkinson's disease (CHAPS).","BACKGROUND
A recent nurse-led proactive care management intervention, Care Coordination for Health Promotion and Activities in Parkinson Disease (CHAPS), improved care quality when compared to usual care in a randomized controlled trial. Therefore, stakeholder (patient participants, nurse care managers, and Parkinson disease (PD) specialists) perceptions of key intervention components merit evaluation to inform decisions about dissemination.
METHODS
This multi-site study occurred in five southwest United States Veterans Health Administration medical centers. Stakeholders were surveyed on their perceptions of CHAPS including the CHAPS Assessment, CHAPS nurse care managers, the Siebens Domain Management Model™ (a practical clinical model), and the Siebens Health Care Notebook (Notebook) (self-care tool). Participants' electronic medical records were abstracted for perceptions of the Notebook. Statistical analysis software was used to provide summary statistics; open card sorting methodology was used to identify themes and attributes in qualitative data including usability of some components.
RESULTS
Participants, overall, highly rated their medication self-management, acknowledged some challenges with the CHAPS self-care tools, reported knowledge of PD specialist follow-up and PD red flags, and rated CHAPS nurse care managers as helpful. Nurse care manager responses indicated the CHAPS Assessment and Program highly facilitated care of their patients. Most all PD specialists would refer other patients to CHAPS. Nurse care manager and PD specialist responses indicated improved participant management of their PD. Three themes emerged in participant perceptions of the Notebook: Notebook Assets (e.g., benefits and features-liked); Deferring Notebook Review (e.g., no time to review); and Reasons for Not Using (e.g., participant preference). Shared attributes regarding the Siebens Domain Management Model and Notebook usability, reported by nurse care managers, were user-friendly, person/patient-centered, and organized. Some challenges to their use were also reported.
CONCLUSIONS
Overall, stakeholder perceptions of the proactive nurse-led CHAPS intervention indicated its value in the care of individuals with PD. Responses about the CHAPS Assessment, Siebens Domain Management Model, and Notebook self-care tool signified their usefulness. Stakeholders' constructive suggestions indicated their engagement in CHAPS. These findings support CHAPS dissemination and contribute to research in care management.
TRIAL REGISTRATION
ClinicalTrials.gov as NCT01532986 , registered on January 13, 2012.",2020,"Overall, stakeholder perceptions of the proactive nurse-led CHAPS intervention indicated its value in the care of individuals with PD.","['five southwest United States Veterans Health Administration medical centers', ""Parkinson's disease (CHAPS"", ""Participants' electronic medical records were abstracted for perceptions of the Notebook""]",['proactive nurse-led CHAPS intervention'],[],"[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0192419,"Overall, stakeholder perceptions of the proactive nurse-led CHAPS intervention indicated its value in the care of individuals with PD.","[{'ForeName': 'Karen I', 'Initials': 'KI', 'LastName': 'Connor', 'Affiliation': ""Veterans Affairs Parkinson's Disease Research, Education and Clinical Center, Los Angeles, CA, USA. kiconnor@ucla.edu.""}, {'ForeName': 'Hilary C', 'Initials': 'HC', 'LastName': 'Siebens', 'Affiliation': 'Siebens Patient Care Communications LLC, Seal Beach, CA, USA.'}, {'ForeName': 'Brian S', 'Initials': 'BS', 'LastName': 'Mittman', 'Affiliation': 'Kaiser Permanente Research, Pasadena, CA, USA.'}, {'ForeName': 'Donna K', 'Initials': 'DK', 'LastName': 'McNeese-Smith', 'Affiliation': 'UCLA School of Nursing, Los Angeles, CA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Ganz', 'Affiliation': 'UCLA David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Barry', 'Affiliation': 'UCLA David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Edwards', 'Affiliation': ""Veterans Affairs Parkinson's Disease Research, Education and Clinical Center, Los Angeles, CA, USA.""}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'McGowan', 'Affiliation': ""Veterans Affairs Parkinson's Disease Research, Education and Clinical Center, Los Angeles, CA, USA.""}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Cheng', 'Affiliation': 'UCLA David Geffen School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Barbara G', 'Initials': 'BG', 'LastName': 'Vickrey', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",BMC neurology,['10.1186/s12883-020-02011-9']
2314,33267815,Separate and combined effects of cold dialysis and intradialytic exercise on the thermoregulatory responses of hemodialysis patients: a randomized-cross-over study.,"BACKGROUND
The separate and combined effects of intradialytic exercise training (IET) and cold dialysis (CD) on patient thermoregulation remain unknown. This study assessed the thermoregulatory responses of hemodialysis patients under four different hemodialysis protocols: a) one typical dialysis (TD) protocol (dialysate temperature at 37 °C), b) one cold dialysis (CD) protocol (dialysate temperature at 35 °C), c) one typical dialysis protocol which included a single exercise bout (TD + E), d) one cold dialysis protocol which included a single exercise bout (CD + E).
METHODS
Ten hemodialysis patients (57.2 ± 14.9 years) participated in this randomized, cross-over study. Core and skin temperatures were measured using an ingestible telemetric pill and by four wireless iButtons attached on the skin, respectively. Body heat storage (S) calculated using the thermometric method proposed by Burton.
RESULTS
The TD and TD + E protocols were associated with increased S leading to moderate effect size increases in core body temperature (as high as 0.4 °C). The low temperature of the dialysate during the CD and the CD + E protocols prevented the rise in S and core temperature (p > 0.05), even during the period that IET took place.
CONCLUSIONS
TD and IET are accompanied by a moderate level of hyperthermia, which can be offset by CD. We recommended that CD or with IET can prevent the excessive rise of S.
TRIAL REGISTRATION
Clinical Trial Registry number: NCT03905551 ( clinicaltrials.gov ), DOR: 05/04/2019.",2020,The TD and TD + E protocols were associated with increased S leading to moderate effect size increases in core body temperature (as high as 0.4 °C).,"['hemodialysis patients under four different hemodialysis protocols', 'hemodialysis patients', 'Ten hemodialysis patients (57.2\u2009±\u200914.9\u2009years']","['intradialytic exercise training (IET) and cold dialysis (CD', 'typical dialysis (TD) protocol (dialysate temperature at 37\u2009°C), b) one cold dialysis (CD) protocol (dialysate temperature at 35\u2009°C), c) one typical dialysis protocol which included a single exercise bout (TD\u2009+\u2009E), d) one cold dialysis protocol which included a single exercise bout (CD\u2009+\u2009E', 'cold dialysis and intradialytic exercise', 'IET']","['rise in S and core temperature', 'Body heat storage (S', 'Core and skin temperatures']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0560033', 'cui_str': 'in/s'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}]",10.0,0.0167918,The TD and TD + E protocols were associated with increased S leading to moderate effect size increases in core body temperature (as high as 0.4 °C).,"[{'ForeName': 'Argyro A', 'Initials': 'AA', 'LastName': 'Krase', 'Affiliation': 'FAME Lab, School of Physical Education, Sport Science and Dietetics, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Andreas D', 'Initials': 'AD', 'LastName': 'Flouris', 'Affiliation': 'FAME Lab, School of Physical Education, Sport Science and Dietetics, University of Thessaly, Trikala, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Karatzaferi', 'Affiliation': 'School of Physical Education, Sport Science and Dietetics, University of Thessaly, Trikala, 42100, Greece.'}, {'ForeName': 'Christoforos D', 'Initials': 'CD', 'LastName': 'Giannaki', 'Affiliation': 'Department of Life and Health Sciences, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Stefanidis', 'Affiliation': 'School of Health Sciences, Department of Medicine, Division of Nephrology, University of Thessaly, Larissa, Greece.'}, {'ForeName': 'Giorgos K', 'Initials': 'GK', 'LastName': 'Sakkas', 'Affiliation': 'School of Physical Education, Sport Science and Dietetics, University of Thessaly, Trikala, 42100, Greece. gsakkas@uth.gr.'}]",BMC nephrology,['10.1186/s12882-020-02167-z']
2315,33267802,Multidimensional analysis of the learning curve for laparoscopic colorectal surgery in a regional hospital: the implementation of a standardized surgical procedure counterbalances the lack of experience.,"BACKGROUND
Although a larger proportion of colorectal surgeries have been performed laparoscopically in the last few years, a steep learning curve prevents us from considering laparoscopic colorectal surgery as the gold standard technique for treating disease entities in the colon and rectum. The purpose of this single centre study was to determine, using various parameters and following a well-structured and standardized surgical procedure, the adequate number of cases after which a single surgeon qualified in open surgery but with no previous experience in laparoscopic colorectal surgery and without supervision, can acquire proficiency in this technique.
METHODS
From 2012 to 2019, 112 patients with pathology in the rectum and colon underwent laparoscopic colorectal resection by a team led by the same surgeon. The patients were divided into two groups (group A:50 - group B:62) and their case records and histopathology reports were examined for predefined parameters, statistically analysed and compared between groups.
RESULTS
There was no significant difference between groups in the distribution of conversions (p = 0.635) and complications (p = 0.637). Patients in both groups underwent surgery for the same median number of lymph nodes (p = 0.145) and stayed the same number of days in the hospital (p = 0.109). A statistically important difference was found in operation duration both for the total (p = 0.006) and for each different type of colectomy (sigmoidectomy: p = 0.026, right colectomy: p = 0.013, extralevator abdominoperineal resection: p = 0.050, low anterior resection: p = 0.083).
CONCLUSIONS
Taking into consideration all the parameters, it is our belief that a surgeon acquires proficiency in laparoscopic colorectal surgery after performing at least 50 diverse cases with a well structured and standardized surgical procedure.",2020,There was no significant difference between groups in the distribution of conversions (p = 0.635) and complications (p = 0.637).,"['From 2012 to 2019, 112 patients with pathology in the rectum and colon underwent']","['abdominoperineal resection', 'laparoscopic colorectal resection', 'laparoscopic colorectal surgery and without supervision', 'laparoscopic colorectal surgery', 'extralevator']","['median number of lymph nodes', 'distribution of conversions', 'operation duration']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0034896', 'cui_str': 'Rectum structure'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}]","[{'cui': 'C2004459', 'cui_str': 'Abdominoperineal resection'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192866', 'cui_str': 'Sigmoid colectomy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",112.0,0.0204927,There was no significant difference between groups in the distribution of conversions (p = 0.635) and complications (p = 0.637).,"[{'ForeName': 'Ioannis G', 'Initials': 'IG', 'LastName': 'Gkionis', 'Affiliation': 'Department of General Surgery, Venizeleio General Hospital, Leoforos Knossou 44, Heraklion, Crete, Greece. ioannisgionis@hotmail.com.'}, {'ForeName': 'Mathaios E', 'Initials': 'ME', 'LastName': 'Flamourakis', 'Affiliation': 'Department of General Surgery, Venizeleio General Hospital, Leoforos Knossou 44, Heraklion, Crete, Greece.'}, {'ForeName': 'Eleni S', 'Initials': 'ES', 'LastName': 'Tsagkataki', 'Affiliation': 'Department of General Surgery, Venizeleio General Hospital, Leoforos Knossou 44, Heraklion, Crete, Greece.'}, {'ForeName': 'Eleni I', 'Initials': 'EI', 'LastName': 'Kaloeidi', 'Affiliation': 'Department of General Surgery, Venizeleio General Hospital, Leoforos Knossou 44, Heraklion, Crete, Greece.'}, {'ForeName': 'Konstantinos G', 'Initials': 'KG', 'LastName': 'Spiridakis', 'Affiliation': 'Department of General Surgery, Venizeleio General Hospital, Leoforos Knossou 44, Heraklion, Crete, Greece.'}, {'ForeName': 'Georgios E', 'Initials': 'GE', 'LastName': 'Kostakis', 'Affiliation': 'Department of General Surgery, Venizeleio General Hospital, Leoforos Knossou 44, Heraklion, Crete, Greece.'}, {'ForeName': 'Athanasios K', 'Initials': 'AK', 'LastName': 'Alegkakis', 'Affiliation': 'Medical School, University of Crete, Andrea Kalokerinou 13, Heraklion, Crete, Greece.'}, {'ForeName': 'Manousos S', 'Initials': 'MS', 'LastName': 'Christodoulakis', 'Affiliation': 'Department of General Surgery, Venizeleio General Hospital, Leoforos Knossou 44, Heraklion, Crete, Greece.'}]",BMC surgery,['10.1186/s12893-020-00975-6']
2316,33267795,"Patients with hip fracture and total hip arthroplasty surgery differ in anthropometric, but not cardiovascular screening abnormalities.","BACKGROUND
With the rising number of hip surgeries, simple and cost-effective tools for surgery risk assessment are warranted. The analysis of heart rate variability (HRV) may not only provide critical insights into the general frailty of patients with hip surgery, but also allow for better differentiation of health profiles in different hip surgery groups. Using HRV analysis, the present study compared cardiovascular as well as anthropometric parameters between patients with hip surgery, the hip fracture surgery group (HFS) and the total hip arthroplasty group (THA), and a control group.
METHODS
71 participants (56.3% women), aged 60-85 years, took part, divided into three groups-patients after hip surgery (21 HFS and 30 THA patients) and a control group (20 participants). Electrocardiogram was recorded at baseline and after the application of a physical stressor (grip strength). A 3 (group) × 2 (time) repeated measures ANOVA, and a chi square test were carried out to test for group differences.
RESULTS
Higher weight (p = .002), body mass index (p = .001), and systolic blood pressure (p = .034) were found in THA patients compared to HFS patients. Lower calf circumference (p = .009) and diastolic blood pressure (p = .048) were observed for the HFS group compared to the control group. For cardiovascular parameters, significant differences emerged between the HFS group and the control group in HR (p = .005), SDNN (p = .034) and SD2 (p = .012). No significant differences in cardiovascular parameters were observed between the two hip surgery groups: neither at baseline nor during stressor recovery.
CONCLUSIONS
While HRV seems to differentiate well between HFS patients and controls, more research with larger samples is needed to scrutinize similaritites and differences in cardiovascular profiles between HFS and THA patients.",2020,"No significant differences in cardiovascular parameters were observed between the two hip surgery groups: neither at baseline nor during stressor recovery.
","['patients with hip surgery, the hip fracture surgery group (HFS) and the total hip arthroplasty group (THA), and a control group', 'Patients with hip fracture and total hip arthroplasty surgery differ in anthropometric, but not cardiovascular screening abnormalities', 'patients with hip surgery', '71 participants (56.3% women), aged 60-85\xa0years, took part, divided into three groups-patients after hip surgery (21 HFS and 30 THA patients) and a control group (20 participants']",['HFS'],"['systolic blood pressure', 'cardiovascular profiles', 'Electrocardiogram', 'body mass index', 'cardiovascular parameters', 'Lower calf circumference', 'diastolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",71.0,0.0278849,"No significant differences in cardiovascular parameters were observed between the two hip surgery groups: neither at baseline nor during stressor recovery.
","[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Csanády-Leitner', 'Affiliation': 'Division of Physiology, Otto Loewi Research Center, Medical University of Graz, Neue Stiftingtalstraße 6/D05, 8036, Graz, Austria. regina.csanady-leitner@stud.medunigraz.at.'}, {'ForeName': 'Franz J', 'Initials': 'FJ', 'LastName': 'Seibert', 'Affiliation': 'Department of Orthopaedics and Trauma, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Corinna M', 'Initials': 'CM', 'LastName': 'Perchtold-Stefan', 'Affiliation': 'Department of Psychology, University of Graz, Universitätsplatz 2/DG, 8010, Graz, Austria.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Maurer-Ertl', 'Affiliation': 'Department of Orthopaedics and Trauma, Medical University of Graz, Auenbruggerplatz 5, 8036, Graz, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Hilgarter', 'Affiliation': 'Division of Physiology, Otto Loewi Research Center, Medical University of Graz, Neue Stiftingtalstraße 6/D05, 8036, Graz, Austria.'}, {'ForeName': 'Helmut K', 'Initials': 'HK', 'LastName': 'Lackner', 'Affiliation': 'Division of Physiology, Otto Loewi Research Center, Medical University of Graz, Neue Stiftingtalstraße 6/D05, 8036, Graz, Austria.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01792-8']
2317,33267769,"Oral mosapride can provide additional anti-emetic efficacy following total joint arthroplasty under general anesthesia: a randomized, double-blinded clinical trial.","BACKGROUND
We sought to determine (1) whether the addition of prophylactic oral mosapride to a protocol including dexamethasone and ondansetron further reduces postoperative nausea and vomiting (PONV) compared with ondansetron alone or the combination of both; (2) whether preemptive application of oral mosapride provides additional clinical benefits for bowel function and appetite, thus improving functional recovery.
METHODS
We randomized 240 patients undergoing total hip and knee arthroplasty to receive placebo (Control, n = 80), dexamethasone (10 mg) before anesthesia induction (Dexa, n = 82), or dexamethasone (10 mg) before anesthesia induction as well as oral mosapride (5 mg) before and after surgery (Mosa+Dexa, n = 78). Patients were assessed at 0-6, 6-12, 12-24, and 24-48 h postoperatively. Primary outcomes were incidence and severity of PONV as well as complete response. Secondary outcomes were appetite, time until first defecation and ambulation, patient satisfaction score, and length of hospital stay.
RESULTS
Mosa+Dexa patients showed significantly lower incidence of nausea at 6-12 h (3.8%) and over the entire evaluation period (6.4%), as well as a higher rate of complete response (89.7%) than other patients. Mosa+Dexa patients required less time to achieve first defecation and ambulation, they were hospitalized for shorter time, and they were more satisfied with clinical care.
CONCLUSION
Addition of oral mosapride further reduced incidence of PONV, especially postoperative nausea, during 6-12 h postoperatively. Moreover, preemptive application of oral mosapride can further improve appetite, bowel function, ambulation and length of hospital stay.
TRIAL REGISTRATION
The study protocol was registered at the Chinese Clinical Trial Registry ( ChiCTR1800015896 ), prospectively registered on 27/04/2018.",2020,"RESULTS
Mosa+Dexa patients showed significantly lower incidence of nausea at 6-12 h (3.8%) and over the entire evaluation period (6.4%), as well as a higher rate of complete response (89.7%) than other patients.","['total joint arthroplasty under general anesthesia', '240 patients undergoing total hip and knee arthroplasty to receive']","['dexamethasone and ondansetron', 'ondansetron', 'placebo (Control, n\u2009=\u200980), dexamethasone (10\u2009mg) before anesthesia induction (Dexa, n\u2009=\u200982), or dexamethasone', 'Mosa+Dexa', 'Oral mosapride']","['appetite, bowel function, ambulation and length of hospital stay', 'appetite, time until first defecation and ambulation, patient satisfaction score, and length of hospital stay', 'incidence and severity of PONV as well as complete response', 'rate of complete response', 'nausea', 'incidence of PONV, especially postoperative nausea', 'postoperative nausea and vomiting (PONV']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0526501', 'cui_str': 'mosapride'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}]",240.0,0.472048,"RESULTS
Mosa+Dexa patients showed significantly lower incidence of nausea at 6-12 h (3.8%) and over the entire evaluation period (6.4%), as well as a higher rate of complete response (89.7%) than other patients.","[{'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Department of Orthopaedic Surgery, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Road, Chengdu, Sichuan Province, 610041, People's Republic of China.""}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ""Department of Orthopaedic Surgery, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Road, Chengdu, Sichuan Province, 610041, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ""Department of Orthopaedic Surgery, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Road, Chengdu, Sichuan Province, 610041, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Department of Orthopaedic Surgery, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Road, Chengdu, Sichuan Province, 610041, People's Republic of China.""}, {'ForeName': 'Fuxing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopaedic Surgery, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, No. 37 Guoxue Road, Chengdu, Sichuan Province, 610041, People's Republic of China. peifuxinghuaxi@126.com.""}]",BMC anesthesiology,['10.1186/s12871-020-01214-4']
2318,33267762,"Intravitreal Dexamethasone Implant Versus Intravitreal Ranibizumab Injection for Treatment of Non-Proliferative Diabetic Macular Edema: A Prospective, Randomized and Blinded trial.","INTRODUCTION
In the working age population, Diabetic Macular Edema (DME) is the most common cause of visual loss.
PURPOSE
The present study is aimed to assess the safety and efficacy of intravitreal injection of Ranibizumab (IVR) versus intravitreal Dexamethasone implant (IVD) in patients with DME in a tertiary care centre over 4 months.
METHODS
This is a comparative, prospective, randomized study that was done on 140 patients with macular edema confirmed on optical coherence tomography (OCT). IVD group received Ozurdex® (Allergan, Inc, Ireland) while the IVR group received Lucentis® (Novartis, Basel, Switzerland) followed up at day-1 and weeks 4, 8, 12,16. Patients were divided into Group A: patients were given 3 doses (monthly) of IVR 0.3 mg in 0.05 ml (n=70). Group B: patients given a single dose of IVD implant 0.7 mg (n=70).
RESULTS
The mean number of injections given was 1 Ozurdex® per patient Vs 3 Lucentis® per patient. The maximum reduction in central macular thickness (CMT) with IVD was 167.8 µm and 138.8µm in the 2nd and 3rd months, respectively with IVR. The Mean best-corrected visual acuity (BCVA) in the 4th month was 0.34 logMAR and 0.33 logMAR, in IVD and IVR group, respectively with consistent improvement. Patients with 0-5 letters, 6-10 letters and 10-15 letters, and >15 letters visibility in IVD group were 9.5, 20.6, 4.8, 6.4 %, and 20.4, 18.8, 20.3 20.3 % in IVR groups, respectively. The maximum intraocular pressure (IOP) rise with IVD was found to be 16 mmHg in 2 patients (3.17 %). The patients with IOP rise >10 mmHg was observed in 14/63 patients (22.22 %), the majority of patients indicated a high rise at 2nd month and all returning to baseline by 4th month. No reports of infectious endophthalmitis or new cataracts were detected in either treated groups.
CONCLUSION
Both intravitreal Ranibizumab injection and Dexamethasone implants were found to be safe and effective in lowering CMT and improving BCVA at the 4-month follow up in patients with DME. Since there was no recurrence in CMT in the Dexamethasone implant group, we suggest that early administration before the 4th month may indicate superior efficacy over the ranibizumab injection. Further randomized trials in a large sample size with a longer period follow-up would be performed to justify the obtained results in the present study.",2020,"The maximum reduction in central macular thickness (CMT) with IVD was 167.8 µm and 138.8µm in the 2nd and 3rd months, respectively with IVR.","['Non-Proliferative Diabetic Macular Edema', 'patients with DME', '140 patients with macular edema confirmed on optical coherence tomography (OCT', 'patients with DME in a tertiary care centre over 4 months']","['Intravitreal Dexamethasone Implant Versus Intravitreal Ranibizumab Injection', 'Ranibizumab (IVR', 'IVD', 'Dexamethasone', 'Ozurdex® (Allergan, Inc, Ireland) while the IVR group received Lucentis® (Novartis, Basel, Switzerland', 'intravitreal Dexamethasone implant (IVD']","['central macular thickness (CMT) with IVD', 'maximum intraocular pressure (IOP) rise with IVD', 'safety and efficacy', 'IOP rise >10 mmHg', 'infectious endophthalmitis or new cataracts', 'Mean best-corrected visual acuity (BCVA', 'mean number of injections given', 'safe and effective in lowering CMT and improving BCVA']","[{'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C2702456', 'cui_str': 'Ozurdex'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C1310652', 'cui_str': 'Importal'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C1532322', 'cui_str': 'Infectious endophthalmitis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0555966', 'cui_str': 'Injection given'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",140.0,0.0392264,"The maximum reduction in central macular thickness (CMT) with IVD was 167.8 µm and 138.8µm in the 2nd and 3rd months, respectively with IVR.","[{'ForeName': 'Sanjay Kumar', 'Initials': 'SK', 'LastName': 'Mishra', 'Affiliation': 'Department of Ophthalmology, Army Base Hospital and Army College of Medical Sciences, Delhi Cantonment, New Delhi. India.'}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'Department of Ophthalmology, Army Base Hospital and Army College of Medical Sciences, Delhi Cantonment, New Delhi. India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Chauhan', 'Affiliation': 'Department of Ophthalmology, Command Hospital, Lucknow Cantonment. India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Ophthalmology, Armed Forces Medical College, Pune. India.'}]",Current drug delivery,['10.2174/1567201817666201202093637']
2319,33267734,"A symmetric anchor designed barbed suture versus conventional interrupted sutures in total knee arthroplasty: A multicenter, randomized controlled trial.","OBJECTIVE
This randomized controlled study was designed to compare the wound closure efficacy and safety of barbed suture in comparison to the conventional interrupted suture for total knee arthroplasty (TKA).
METHODS
This multicenter, single-blind, randomized controlled trial enrolled 184 patients who underwent elective TKA between June 2017 and April 2018. The subjects were randomized between two groups. Surgical incision closure time was considered as the primary end point.
RESULTS
A total of 184 patients participated in this randomized controlled trial; 91 patients had wound closure that involved barbed suture and 93 patients underwent conventional treatment-that is interrupted suturing with nonbarbed sutures. The surgical incision closure time was shorter ( p < 0.0001) in the barbed suture group compared with the control group (15.5 ± 4.88 vs. 20.9 ± 6.30 min). However, both groups were found to be equal in terms of the rate of postoperative complications.
CONCLUSION
Usage of the symmetric anchor designed barbed suture is safe, efficacious, and demonstrates a decrease in surgical incision closure time in patients undergoing TKA compared to interrupted closure using conventional sutures. Future studies are warranted to demonstrate clinical and economic benefits of barbed sutures.",2020,The surgical incision closure time was shorter ( p < 0.0001) in the barbed suture group compared with the control group (15.5 ± 4.88 vs. 20.9 ± 6.30 min).,"['184 patients who underwent elective TKA between June 2017 and April 2018', 'patients undergoing', 'and 93 patients underwent', 'total knee arthroplasty', '184 patients participated in this randomized controlled trial; 91 patients had', 'total knee arthroplasty (TKA']","['barbed suture', 'TKA', 'wound closure that involved barbed suture', 'conventional interrupted suture', 'conventional treatment-that is interrupted suturing with nonbarbed sutures', 'symmetric anchor designed barbed suture versus conventional interrupted sutures', 'symmetric anchor designed barbed suture']","['Surgical incision closure time', 'rate of postoperative complications', 'surgical incision closure time']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",184.0,0.153415,The surgical incision closure time was shorter ( p < 0.0001) in the barbed suture group compared with the control group (15.5 ± 4.88 vs. 20.9 ± 6.30 min).,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Second Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Shigui', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Orthopaedic Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chai', 'Affiliation': 'Department of Orthopedics, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Zuo', 'Affiliation': 'Department of Orthopedics, China-Japan Union Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Department of Orthopedics, Tongji Hospital, Wuhan, China.'}, {'ForeName': 'Schmitz', 'Initials': 'S', 'LastName': 'Niels-Derrek', 'Affiliation': 'Ethicon Inc., Somerville, NJ, USA.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Ethicon Inc., Somerville, NJ, USA.'}, {'ForeName': 'Bhattacharya', 'Initials': 'B', 'LastName': 'Sanghita', 'Affiliation': 'Ethicon Inc., Somerville, NJ, USA.'}, {'ForeName': 'Ilie', 'Initials': 'I', 'LastName': 'Bogdan', 'Affiliation': 'Ethicon Inc., Somerville, NJ, USA.'}, {'ForeName': 'Kunzheng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, Second Hospital of Xi'an Jiaotong University, Xi'an, China.""}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499020965681']
2320,33267729,Perceptual Learning of Vocoded Speech With and Without Contralateral Hearing: Implications for Cochlear Implant Rehabilitation.,"Purpose An increasing number of individuals with residual or even normal contralateral hearing are being considered for cochlear implantation. It remains unknown whether the presence of contralateral hearing is beneficial or detrimental to their perceptual learning of cochlear implant (CI)-processed speech. The aim of this experiment was to provide a first insight into this question using acoustic simulations of CI processing. Method Sixty normal-hearing listeners took part in an auditory perceptual learning experiment. Each subject was randomly assigned to one of three groups of 20 referred to as NORMAL, LOWPASS, and NOTHING. The experiment consisted of two test phases separated by a training phase. In the test phases, all subjects were tested on recognition of monosyllabic words passed through a six-channel ""PSHC"" vocoder presented to a single ear. In the training phase, which consisted of listening to a 25-min audio book, all subjects were also presented with the same vocoded speech in one ear but the signal they received in their other ear differed across groups. The NORMAL group was presented with the unprocessed speech signal, the LOWPASS group with a low-pass filtered version of the speech signal, and the NOTHING group with no sound at all. Results The improvement in speech scores following training was significantly smaller for the NORMAL than for the LOWPASS and NOTHING groups. Conclusions This study suggests that the presentation of normal speech in the contralateral ear reduces or slows down perceptual learning of vocoded speech but that an unintelligible low-pass filtered contralateral signal does not have this effect. Potential implications for the rehabilitation of CI patients with partial or full contralateral hearing are discussed.",2020,The improvement in speech scores following training was significantly smaller for the NORMAL than for the LOWPASS and NOTHING groups.,"['CI patients with partial or full contralateral hearing', 'Method Sixty normal-hearing listeners took part in an auditory perceptual learning experiment', 'individuals with residual or even normal contralateral hearing']","['Perceptual Learning of Vocoded Speech', 'LOWPASS']",['speech scores'],"[{'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0234725', 'cui_str': 'Hearing normal'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0166966,The improvement in speech scores following training was significantly smaller for the NORMAL than for the LOWPASS and NOTHING groups.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Chavant', 'Affiliation': ""Aix-Marseille University, Centre National de la Recherche Scientifique, Centrale Marseille, Laboratoire de Mécanique et d'Acoustique, France.""}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Hervais-Adelman', 'Affiliation': 'Department of Psychology - Neurolinguistics, University of Zurich, Switzerland.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Macherey', 'Affiliation': ""Aix-Marseille University, Centre National de la Recherche Scientifique, Centrale Marseille, Laboratoire de Mécanique et d'Acoustique, France.""}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00385']
2321,33267706,The role of base-layer cooling conditions in human error occurrences during doffing of personal protective equipment in health care.,"This study compared error rates during the personal protective equipment (PPE) removal process under the different base-layer cooling conditions while performing the doffing procedures. Ten participants were recruited and received training on the standard doffing procedures before participating in the experiments. The participants were randomly assigned to one of the three base-layer conditions and run on a treadmill for 30 min. Their physiological biometrics were monitored during exercise trials, and error rates were calculated. The results revealed a significant difference in error rates when PPE was worn over base-layer scrubs made of a cooling fabric, versus when it was worn over the conventional medical scrubs. Further there was a strong negative relationship between the body coverage amount with the cooling fabric and error rates occurring during the doffing procedures. Findings suggested practical considerations for the operational monitoring system and improved PPE design to avoid unintentional errors during the doffing procedures.",2020,Findings suggested practical considerations for the operational monitoring system and improved PPE design to avoid unintentional errors during the doffing procedures.,"['Ten participants were recruited and received training on the standard doffing procedures before participating in the experiments', 'human error occurrences during doffing of personal protective equipment in health care']",['personal protective equipment (PPE'],['error rates'],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]","[{'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]",[],10.0,0.0335029,Findings suggested practical considerations for the operational monitoring system and improved PPE design to avoid unintentional errors during the doffing procedures.,"[{'ForeName': 'Juyeon', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Textiles, Merchandising, and Fashion Design, Research Institute of Human Ecology, Seoul National University, Seoul, Republic of Korea.'}]",International journal of occupational safety and ergonomics : JOSE,['10.1080/10803548.2020.1858611']
2322,33267670,Robotic Radical Cystectomy Outcomes after Intervention for Prostate Cancer.,"INTRODUCTION AND OBJECTIVES
We evaluated patients who underwent treatment for prostate cancer and then subsequent robotic radical cystectomy (RARC). Our objective was to understand clinical, pathologic, and survival outcomes in these patients.
MATERIALS AND METHODS
A total of 333 male patients underwent RARC with standard intracorporeal urinary diversion from 2009 to 2019. We evaluated patients who underwent a radical prostatectomy (RP) and either external beam radiation or brachytherapy (XRT) prior to RARC. These patients were compared to patients who underwent RARC without any prior intervention for or history of prostate cancer (RC).
RESULTS
Patients in the RP and XRT groups were found to be older than the RC group (p = 0.0108) and also have a greater Charlston Comorbidity Index (p<0.001). There was no difference in estimated blood loss, operative time and length of stay across all three groups. The RP group had a higher rate of positive margins 31.58% compared to RC and XRT at 8.22% and 10.00%, respectively (p=0.0036). There was also a higher rate of extravesical disease on final pathology for the XRT group at 60.00% compared to 37.5% and 36.85% for RC and RP, respectively (p=0.0056). Overall Survival was lowest in the XRT group compared to RP and RC (p>0.001) with no difference in recurrence-free survival.
CONCLUSION
Patients in the RP group have higher rates of positive margin, while patients in the XRT group have higher rates of extravesical disease and overall survival after undergoing a RARC. Careful counseling and attention to these parameters is required in these patient populations.",2020,"Overall Survival was lowest in the XRT group compared to RP and RC (p>0.001) with no difference in recurrence-free survival.
","['patients who underwent treatment for prostate cancer and then subsequent', '333 male patients underwent RARC with standard intracorporeal urinary diversion from 2009 to 2019', 'Prostate Cancer']","['Robotic Radical Cystectomy', 'RARC', 'robotic radical cystectomy (RARC', 'XRT', 'radical prostatectomy (RP) and either external beam radiation or brachytherapy (XRT) prior to RARC']","['higher rates of positive margin', 'estimated blood loss, operative time and length of stay', 'rate of positive margins', 'Charlston Comorbidity Index', 'recurrence-free survival', 'extravesical disease and overall survival', 'Overall Survival', 'rate of extravesical disease on final pathology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0194401', 'cui_str': 'Complete cystectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0442096', 'cui_str': 'Extravesical approach'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]",333.0,0.041083,"Overall Survival was lowest in the XRT group compared to RP and RC (p>0.001) with no difference in recurrence-free survival.
","[{'ForeName': 'Neel H', 'Initials': 'NH', 'LastName': 'Patel', 'Affiliation': 'University of Southern California, USC Institute of Urology , Urology, Los Angeles, California, United States.'}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Miranda', 'Affiliation': 'University of Southern California, USC Institute of Urology, 1441 Eastlake Avenue, Suite 7416, Los Angeles, California, United States, 90089; gmiranda@med.usc.edu.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'University of Southern California - USC, USC Institute of Urology, Los Angeles, California, United States; jie.cai@med.usc.edu.'}, {'ForeName': 'Mihir M', 'Initials': 'MM', 'LastName': 'Desai', 'Affiliation': 'USC, Institute of Urology, 1441 Eastlake Avenue, STE 7416, Los Angeles, California, United States, 90089; mihir.desai@med.usc.edu.'}, {'ForeName': 'Inderbir', 'Initials': 'I', 'LastName': 'Gill', 'Affiliation': 'University of Southern California, 5116, Los Angeles, California, United States; igill@med.usc.edu.'}, {'ForeName': 'Monish', 'Initials': 'M', 'LastName': 'Aron', 'Affiliation': 'University of Southern California, 5116, Los Angeles, California, United States; monish.aron@med.usc.edu.'}]",Journal of endourology,['10.1089/end.2020.0627']
2323,33267591,Effectiveness of Almagate in gastroesophageal reflux disease: a post-hoc analysis of a randomized cross-over double-blind study.,Not applicable.,2020,Not applicable.,['gastroesophageal reflux disease'],['Almagate'],[],"[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]","[{'cui': 'C0051244', 'cui_str': 'almagate'}]",[],,0.286456,Not applicable.,"[{'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Mearin', 'Affiliation': 'Aparato Digestivo, Centro Médico Teknon, España.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pajuelo Lorenzo', 'Affiliation': 'Departamento Médico, Almirall, España.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ríos', 'Affiliation': 'Departamento de Estadística, Hospital Clínic, España.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2020.7449/2020']
2324,33267558,Impact of an 8-Year Intensive Lifestyle Intervention on an Index of Multimorbidity.,"BACKGROUND/OBJECTIVES
Type 2 diabetes mellitus and obesity are sometimes described as conditions that accelerate aging. Multidomain lifestyle interventions have shown promise to slow the accumulation of age-related diseases, a hallmark of aging. However, they have not been assessed among at-risk individuals with these two conditions. We examined the relative impact of 8 years of a multidomain lifestyle intervention on an index of multimorbidity.
DESIGN
Randomized controlled clinical trial comparing an intensive lifestyle intervention (ILI) that targeted weight loss through caloric restriction and increased physical activity with a control condition of diabetes support and education (DSE).
SETTING
Sixteen U.S. academic centers.
PARTICIPANTS
A total of 5,145 volunteers, aged 45 to 76, with established type 2 diabetes mellitus and overweight or obesity who met eligibility criteria for a randomized controlled clinical trial.
MEASUREMENTS
A multimorbidity index that included nine age-related chronic diseases and death was tracked over 8 years of intervention delivery.
RESULTS
Among individuals assigned to DSE, the multimorbidity index scores increased by an average of .98 (95% confidence interval [CI] = .94-1.02) over 8 years, compared with .89 (95% CI = .85-.93) among those in the multidomain ILI, which was a 9% difference (P = .003). Relative intervention effects were similar among individuals grouped by baseline body mass index, age, and sex, and they were greater for those with lower levels of multimorbidity index scores at baseline.
CONCLUSIONS
Increases in multimorbidity over time among adults with overweight or obesity and type 2 diabetes mellitus may be slowed by multidomain ILI. J Am Geriatr Soc 68:2249-2256, 2020.",2020,"Among individuals assigned to DSE, the multimorbidity index scores increased by an average of .98","['A total of 5,145 volunteers, aged 45 to 76, with established type 2 diabetes mellitus and overweight or obesity who met eligibility criteria for a randomized controlled clinical trial', 'Sixteen U.S. academic centers', 'adults with overweight or obesity and type 2 diabetes mellitus']","['Multidomain lifestyle interventions', 'multidomain lifestyle intervention', '8-Year Intensive Lifestyle Intervention', 'intensive lifestyle intervention (ILI) that targeted weight loss through caloric restriction and increased physical activity with a control condition of diabetes support and education (DSE']","['multimorbidity index scores', 'Index of Multimorbidity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0936233', 'cui_str': 'Controlled Clinical Trial'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C1135809', 'cui_str': 'Decreased energy diet'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",5145.0,0.129081,"Among individuals assigned to DSE, the multimorbidity index scores increased by an average of .98","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Gaussoin', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Bahnson', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Vaughan', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, USA.'}, {'ForeName': 'Felicia R', 'Initials': 'FR', 'LastName': 'Simpson', 'Affiliation': 'Department of Mathematics, Winston-Salem State University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Clinical Epidemiology, University of Texas Health Science Center, San Antonio, Texas, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Medha N', 'Initials': 'MN', 'LastName': 'Munshi', 'Affiliation': 'Joslin Geriatric Diabetes Program, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Department of Medicine, Columbia University School of Medicine, New York, New York, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16672']
2325,33267545,[Comparative analysis of calcium hydroxide apexification and regenerative endodontic procedure for root dentine growth stimulation in immature incisors with pulp necrosis].,"THE AIM OF THE STUDY
Was to compare the efficacy of Ca(OH) 2 apexification and regenerative endodontic procedure (REP) in immature teeth with pulp necrosis. The pilot study included 12 children aged 89 to 126 months having pulp necrosis in immature incisors. Dental trauma was the etiology for pulp necrosis in all cases and initial X-rays showed periapical translucency lesions (PTL). The patients were randomly divided in 2 groups with either Ca(OH) 2 apexification (group 1, n =6) or REP (group 2, n =6). The root length and the growth of root wall thickness, as well as root to crown ratio and dentinal wall to root canal space ratio was assessed radiologically in 6, 12 and 24 months. The root length increase was detected in 83% of all cases, but the pattern of root dentine growth in the groups was different. Dentin thickness in REP group was more prominent in the apical third and was observed in 100% of cases while in group 1 dentin thickness increased mainly in the coronal and middle third of the root, dentin thickness increased only in 33% of all cases in the apexification group. PTL were successfully eliminated in both groups.
CONCLUSION
Results and complications of both methods allow limiting indications for their usage. Ca(OH) 2 apexification is more reliable in cases of pulp necrosis in teeth with III and IV stages of root formation when an estimated time for apexification is 3 to 6 months, under condition of good patient cooperation and possibility for good marginal fit of the restoration. REP is indicated in cases with I, II and III stages of root formation, as well as initial root resorption signs regardless of root formation stage.",2020,"Dentin thickness in REP group was more prominent in the apical third and was observed in 100% of cases while in group 1 dentin thickness increased mainly in the coronal and middle third of the root, dentin thickness increased only in 33% of all cases in the apexification group.","['immature teeth with pulp necrosis', '12 children aged 89 to 126 months having pulp necrosis in immature incisors', 'immature incisors with pulp necrosis']","['REP', 'Ca(OH', 'Ca(OH) 2 apexification and regenerative endodontic procedure (REP', 'Ca(OH) 2 apexification', 'calcium hydroxide apexification and regenerative endodontic procedure']","['dentin thickness', 'periapical translucency lesions (PTL', 'root dentine growth', 'root length increase', 'root length and the growth of root wall thickness, as well as root to crown ratio and dentinal wall to root canal space ratio', 'Dentin thickness']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011407', 'cui_str': 'Necrosis of the pulp'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C2193547', 'cui_str': 'Apexification'}, {'cui': 'C4704832', 'cui_str': 'Regenerative Endodontics'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0522503', 'cui_str': 'Translucent'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",12.0,0.0162298,"Dentin thickness in REP group was more prominent in the apical third and was observed in 100% of cases while in group 1 dentin thickness increased mainly in the coronal and middle third of the root, dentin thickness increased only in 33% of all cases in the apexification group.","[{'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Rakhmanova', 'Affiliation': 'National Medical Research Center of Dentistry and Maxillofacial Surgery, Moscow, Russia.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Korolenkova', 'Affiliation': 'National Medical Research Center of Dentistry and Maxillofacial Surgery, Moscow, Russia.'}]",Stomatologiia,['10.17116/stomat20209906155']
2326,33267131,Entropy Rate Superpixel Classification for Automatic Red Lesion Detection in Fundus Images.,"Diabetic retinopathy (DR) is the main cause of blindness in the working-age population in developed countries. Digital color fundus images can be analyzed to detect lesions for large-scale screening. Thereby, automated systems can be helpful in the diagnosis of this disease. The aim of this study was to develop a method to automatically detect red lesions (RLs) in retinal images, including hemorrhages and microaneurysms. These signs are the earliest indicators of DR. Firstly, we performed a novel preprocessing stage to normalize the inter-image and intra-image appearance and enhance the retinal structures. Secondly, the Entropy Rate Superpixel method was used to segment the potential RL candidates. Then, we reduced superpixel candidates by combining inaccurately fragmented regions within structures. Finally, we classified the superpixels using a multilayer perceptron neural network. The used database contained 564 fundus images. The DB was randomly divided into a training set and a test set. Results on the test set were measured using two different criteria. With a pixel-based criterion, we obtained a sensitivity of 81.43% and a positive predictive value of 86.59%. Using an image-based criterion, we reached 84.04% sensitivity, 85.00% specificity and 84.45% accuracy. The algorithm was also evaluated on the DiaretDB1 database. The proposed method could help specialists in the detection of RLs in diabetic patients.",2019,"With a pixel-based criterion, we obtained a sensitivity of 81.43% and a positive predictive value of 86.59%.","['Diabetic retinopathy (DR', 'diabetic patients']",[],[],"[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0278441,"With a pixel-based criterion, we obtained a sensitivity of 81.43% and a positive predictive value of 86.59%.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Romero-Oraá', 'Affiliation': 'Biomedical Engineering Group, E.T.S.I. de Telecomunicación, University of Valladolid, 47011 Valladolid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Jiménez-García', 'Affiliation': 'Biomedical Engineering Group, E.T.S.I. de Telecomunicación, University of Valladolid, 47011 Valladolid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'García', 'Affiliation': 'Biomedical Engineering Group, E.T.S.I. de Telecomunicación, University of Valladolid, 47011 Valladolid, Spain.'}, {'ForeName': 'María I', 'Initials': 'MI', 'LastName': 'López-Gálvez', 'Affiliation': 'Biomedical Engineering Group, E.T.S.I. de Telecomunicación, University of Valladolid, 47011 Valladolid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Oraá-Pérez', 'Affiliation': 'Department of Ophthalmology, Hospital Clínico Universitario de Valladolid, 47003 Valladolid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hornero', 'Affiliation': 'Biomedical Engineering Group, E.T.S.I. de Telecomunicación, University of Valladolid, 47011 Valladolid, Spain.'}]","Entropy (Basel, Switzerland)",['10.3390/e21040417']
2327,33266870,Sensorless Pose Determination Using Randomized Action Sequences.,"This paper is a study of 2D manipulation without sensing and planning, by exploring the effects of unplanned randomized action sequences on 2D object pose uncertainty. Our approach follows the work of Erdmann and Mason's sensorless reorienting of an object into a completely determined pose, regardless of its initial pose. While Erdmann and Mason proposed a method using Newtonian mechanics, this paper shows that under some circumstances, a long enough sequence of random actions will also converge toward a determined final pose of the object. This is verified through several simulation and real robot experiments where randomized action sequences are shown to reduce entropy of the object pose distribution. The effects of varying object shapes, action sequences, and surface friction are also explored.",2019,This is verified through several simulation and real robot experiments where randomized action sequences are shown to reduce entropy of the object pose distribution.,[],[],[],[],[],[],,0.0181861,This is verified through several simulation and real robot experiments where randomized action sequences are shown to reduce entropy of the object pose distribution.,"[{'ForeName': 'Pragna', 'Initials': 'P', 'LastName': 'Mannam', 'Affiliation': 'The Robotics Institute, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Volkov', 'Affiliation': 'The Robotics Institute, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Paolini', 'Affiliation': 'The Robotics Institute, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Chirikjian', 'Affiliation': 'Department Of Mechanical Engineering, Johns Hopkins University, Baltimore, MD 21218, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Mason', 'Affiliation': 'The Robotics Institute, Carnegie Mellon University, Pittsburgh, PA 15213, USA.'}]","Entropy (Basel, Switzerland)",['10.3390/e21020154']
2328,33266464,Improvement of Gait after 4 Weeks of Wearable Focal Muscle Vibration Therapy for Individuals with Diabetic Peripheral Neuropathy.,"People with diabetic peripheral neuropathy (DPN) experience lower quality of life caused by associated balance, posture, and gait impairments. While focal muscle vibration (FMV) has been associated with improvements in gait performance in individuals with neurological disorders, little is known about its effectiveness in patients with DPN. The purpose of this study was to investigate the effect of FMV on gait outcomes in patients with DPN. The authors randomized 23 participants into three FMV intervention groups depending upon the delivery of vibration. Participants applied wearable FMV to the bilateral quadriceps, gastrocnemius, and tibialis anterior, 10 min per muscle, three times per week over a four-week period. Spatiotemporal, kinematic, and kinetic gait parameters at baseline and post-intervention were calculated and analyzed. Gait speed, cadence, stride time, left and right stance time, duration of double limb support, and left and right knee flexor moments significantly improved after four weeks of FMV. Trends toward significant improvements were noted in maximum left and right knee flexion. Results indicate that FMV therapy was associated with improvements in gait parameters in individuals with DPN, warranting expanded study of FMV therapy for long-term gait performance improvement in these individuals.",2020,"People with diabetic peripheral neuropathy (DPN) experience lower quality of life caused by associated balance, posture, and gait impairments.","['Individuals with Diabetic Peripheral Neuropathy', 'individuals with DPN', 'individuals with neurological disorders', 'People with diabetic peripheral neuropathy (DPN', 'patients with DPN']","['FMV', 'FMV therapy', 'Wearable Focal Muscle Vibration Therapy', 'FMV intervention']","['maximum left and right knee flexion', 'Gait speed, cadence, stride time, left and right stance time, duration of double limb support, and left and right knee flexor moments', 'gait parameters', 'gait performance', 'gait outcomes', 'Spatiotemporal, kinematic, and kinetic gait parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0740447', 'cui_str': 'Diabetic peripheral neuropathy'}, {'cui': 'C0027765', 'cui_str': 'Disorder of nervous system'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4281598', 'cui_str': 'Structure of right knee region'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",23.0,0.0276572,"People with diabetic peripheral neuropathy (DPN) experience lower quality of life caused by associated balance, posture, and gait impairments.","[{'ForeName': 'Josiah', 'Initials': 'J', 'LastName': 'Rippetoe', 'Affiliation': 'Department of Rehabilitation Sciences, College of Allied Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Hongwu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Sciences, College of Allied Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Shirley A', 'Initials': 'SA', 'LastName': 'James', 'Affiliation': 'Department of Rehabilitation Sciences, College of Allied Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Dionne', 'Affiliation': 'Department of Rehabilitation Sciences, College of Allied Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Block', 'Affiliation': 'Department of Rehabilitation Sciences, College of Allied Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Beckner', 'Affiliation': 'Department of Rehabilitation Sciences, College of Allied Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73104, USA.'}]",Journal of clinical medicine,['10.3390/jcm9113767']
2329,33266447,"Twelve-Week Daily Consumption of ad hoc Fortified Milk with ω-3, D, and Group B Vitamins Has a Positive Impact on Inflammaging Parameters: A Randomized Cross-Over Trial.","BACKGROUND AND AIM
A state of chronic, subclinical inflammation known as inflammaging is present in elderly people and represents a risk factor for all age-related diseases. Dietary supplementation with ad hoc fortified foods seems an appealing strategy to counteract inflammaging. The purpose of this study was to test the efficacy of elderly-tailored fortified milk on inflammaging and different health parameters.
METHODS
A double-blind randomized cross-over study was performed on forty-eight volunteers aged 63-80 years. The fortified milk was enriched with ω-3 polyunsaturated fatty acids (eicosapentaenoic acid, EPA; docosahexaenoic acid, DHA), vitamins (25-hydroxyvitamin D, E, C, B6, B9, B12), and trace elements (zinc, selenium). The two intervention periods lasted for 12 weeks, with a 16-week washout intermission.
RESULTS
Compared to placebo, the consumption of fortified milk increased the circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes. Conversely, it reduced the amount of arachidonic acid, homocysteine, and ω-6/ω-3 ratio.
CONCLUSION
Twelve-week daily consumption of ad hoc fortified milk has an overall positive impact on different health parameters related to inflammaging in the elderly.",2020,"Compared to placebo, the consumption of fortified milk increased the circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes.","['elderly people', 'forty-eight volunteers aged 63-80 years']","['ω-3 polyunsaturated fatty acids (eicosapentaenoic acid, EPA; docosahexaenoic acid, DHA), vitamins (25-hydroxyvitamin D, E, C, B6, B9, B12), and trace elements (zinc, selenium', 'elderly-tailored fortified milk', 'placebo']","['circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes', 'arachidonic acid, homocysteine, and ω-6/ω-3 ratio']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1532525', 'cui_str': 'Fortified milk'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",48.0,0.0830432,"Compared to placebo, the consumption of fortified milk increased the circulating levels of different micronutrients, including vitamins and the ω-3 index of erythrocyte membranes.","[{'ForeName': 'Morena', 'Initials': 'M', 'LastName': 'Martucci', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Conte', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Giampieri', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Fabbri', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Maria Giustina', 'Initials': 'MG', 'LastName': 'Palmas', 'Affiliation': 'Alma Mater Research Institute on Global Challenges and Climate Change (Alma Climate), University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Izzi', 'Affiliation': 'Alma Mater Research Institute on Global Challenges and Climate Change (Alma Climate), University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Salvioli', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Angelo Vittorio', 'Initials': 'AV', 'LastName': 'Zambrini', 'Affiliation': 'Department of Quality, Innovation, Safety, Environment, Granarolo S.p.A., 40057 Bologna, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Orsi', 'Affiliation': 'Department of Quality, Innovation, Safety, Environment, Granarolo S.p.A., 40057 Bologna, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Brigidi', 'Affiliation': 'Unit of Microbial Ecology of Health, Department of Pharmacy and Biotechnology, University of Bologna, 40126 Bologna, Italy.'}, {'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Capri', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Monti', 'Affiliation': 'Department of Experimental and Clinical Biomedical Sciences ""Mario Serio"", University of Florence, 50134 Florence, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Franceschi', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, 40138 Bologna, Italy.'}]",Nutrients,['10.3390/nu12113580']
2330,33266407,Short-Term Core Strengthening Program Improves Functional Movement Score in Untrained College Students.,"Functional movement is an important part of developing athletes' but also untrained individuals' performance. Its monitoring also proved useful in identifying functional limitations and asymmetries, and also in determining the intervention effects. The quasi-experimental pre-test post-test study investigated the effects of core stability training program on the Functional Movement Screen (FMS) score in untrained students after six weeks. The intervention (INT) and control (CG) groups included 73 and 65 male students, respectively. Functional movement patterns were evaluated using the FMS including seven components scores representing seven basic functional patterns. Both groups significantly improved almost all FMS components scores, but the INT increased the mean performance of the hurdle step (partial ŋ 2 × 100 = 4%, p = 0.02), in-line lunge (partial ŋ 2 × 100 = 3%, p = 0.05), rotatory stability (partial ŋ 2 × 100 = 4%, p = 0.02) and total FMS (partial ŋ 2 × 100 = 3%, p = 0.04) significantly more than the CG. This justifies that core strengthening can improve FMS in untrained individuals even with the short duration programs.",2020,"Both groups significantly improved almost all FMS components scores, but the INT increased the mean performance of the hurdle step (partial ŋ 2 × 100 = 4%, p = 0.02), in-line lunge (partial ŋ 2 × 100 = 3%, p = 0.05), rotatory stability (partial ŋ 2 × 100 = 4%, p = 0.02) and total FMS (partial ŋ 2 × 100 = 3%, p = 0.04) significantly more than the CG.","['Untrained College Students', 'untrained students after six weeks', 'groups included 73 and 65 male students, respectively']","['intervention (INT) and control (CG', 'core stability training program', 'Short-Term Core Strengthening Program']","['total FMS', 'Functional Movement Screen (FMS) score', 'FMS components scores', 'mean performance of the hurdle step', 'rotatory stability', 'Functional Movement Score']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0224044,"Both groups significantly improved almost all FMS components scores, but the INT increased the mean performance of the hurdle step (partial ŋ 2 × 100 = 4%, p = 0.02), in-line lunge (partial ŋ 2 × 100 = 3%, p = 0.05), rotatory stability (partial ŋ 2 × 100 = 4%, p = 0.02) and total FMS (partial ŋ 2 × 100 = 3%, p = 0.04) significantly more than the CG.","[{'ForeName': 'Tijana', 'Initials': 'T', 'LastName': 'Šćepanović', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Branka', 'Initials': 'B', 'LastName': 'Protić-Gava', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Goran', 'Initials': 'G', 'LastName': 'Sporiš', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10000 Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Rupčić', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10000 Zagreb, Croatia.'}, {'ForeName': 'Zvonko', 'Initials': 'Z', 'LastName': 'Miljković', 'Affiliation': 'Faculty of Mechanical Engineering, University of Osijek, 35000 Slavonski Brod, Croatia.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Liapikos', 'Affiliation': 'Primary School of Demenika, 26000 Patras, Greece.'}, {'ForeName': 'Draženka', 'Initials': 'D', 'LastName': 'Mačak', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Dejan M', 'Initials': 'DM', 'LastName': 'Madić', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}, {'ForeName': 'Nebojša', 'Initials': 'N', 'LastName': 'Trajković', 'Affiliation': 'Faculty of Sport and Physical Education, University of Novi Sad, 21000 Novi Sad, Serbia.'}]",International journal of environmental research and public health,['10.3390/ijerph17228669']
2331,33266325,Appetite Control across the Lifecourse: The Acute Impact of Breakfast Drink Quantity and Protein Content. The Full4Health Project.,"Understanding the mechanisms of hunger, satiety and how nutrients affect appetite control is important for successful weight management across the lifecourse. The primary aim of this study was to describe acute appetite control across the lifecourse, comparing age groups (children, adolescents, adults, elderly), weight categories, genders and European sites (Scotland and Greece). Participants ( n = 391) consumed four test drinks, varying in composition (15% (normal protein, NP) and 30% (high protein, HP) of energy from protein) and quantity (based on 100% basal metabolic rate (BMR) and 140% BMR), on four separate days in a double-blind randomized controlled study. Ad libitum energy intake (EI), subjective appetite and biomarkers of appetite and metabolism (adults and elderly only) were measured. The adults' appetite was significantly greater than that of the elderly across all drink types ( p < 0.004) and in response to drink quantities ( p < 0.001). There were no significant differences in EI between age groups, weight categories, genders or sites. Concentrations of glucagon-like peptide 1 (GLP-1) and peptide YY (PYY) were significantly greater in the elderly than the adults ( p < 0.001). Ghrelin and fasting leptin concentrations differed significantly between weight categories, genders and sites ( p < 0.05), while GLP-1 and PYY concentrations differed significantly between genders only ( p < 0.05). Compared to NP drinks, HP drinks significantly increased postprandial GLP-1 and PYY ( p < 0.001). Advanced age was concomitant with reduced appetite and elevated anorectic hormone release, which may contribute to the development of malnutrition. In addition, appetite hormone concentrations differed between weight categories, genders and geographical locations.",2020,"Compared to NP drinks, HP drinks significantly increased postprandial GLP-1 and PYY ( p < 0.001).","['Appetite Control across the Lifecourse', 'age groups (children, adolescents, adults, elderly), weight categories, genders and European sites (Scotland and Greece']",[],"['postprandial GLP-1', 'response to drink quantities', 'Ghrelin and fasting leptin concentrations', ""adults' appetite"", 'appetite hormone concentrations', 'Concentrations of glucagon-like peptide 1 (GLP-1) and peptide YY (PYY', 'Ad libitum energy intake (EI), subjective appetite and biomarkers of appetite and metabolism (adults and elderly only', 'GLP-1 and PYY concentrations']","[{'cui': 'C0003622', 'cui_str': 'Appetite control'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]",[],"[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",391.0,0.0324194,"Compared to NP drinks, HP drinks significantly increased postprandial GLP-1 and PYY ( p < 0.001).","[{'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Crabtree', 'Affiliation': 'Centre for Health Science, Division of Biomedical Sciences, University of the Highlands and Islands, Old Perth Road, Inverness IV2 3JH, Scotland, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Buosi', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill Road, Aberdeen AB25 2ZD, Scotland, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Fyfe', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill Road, Aberdeen AB25 2ZD, Scotland, UK.'}, {'ForeName': 'Graham W', 'Initials': 'GW', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Foresterhill Road, Aberdeen AB25 2ZD, Scotland, UK.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition-Dietetics, School of Health Science & Education, Harokopio University Athens, 70 El. Venizelou Avenue, 17671 Kallithea, Greece.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Physical Education, Sport Science and Dietetics, University of Thessaly, 42100 Trikala, Greece.'}, {'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Giannopoulou', 'Affiliation': 'Department of Nutrition-Dietetics, School of Health Science & Education, Harokopio University Athens, 70 El. Venizelou Avenue, 17671 Kallithea, Greece.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, England, UK.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, University of Leeds, Leeds LS2 9JT, England, UK.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Meek', 'Affiliation': ""Institute of Metabolic Science, Metabolic Research Laboratories, University of Cambridge, Addenbrooke's Hospital, Box 289, Hills Road, Cambridge CB2 0QQ, England, UK.""}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences and Novo Nordisk Foundation Center for Basic Metabolic Research, University of Copenhagen, DK-2200 Copenhagen, Denmark.'}, {'ForeName': 'Klaske Van', 'Initials': 'KV', 'LastName': 'Van Norren', 'Affiliation': 'Nutritional Biology, Human Nutrition and Health, Wageningen University, 6708 WE Wageningen, The Netherlands.'}, {'ForeName': 'Julian G', 'Initials': 'JG', 'LastName': 'Mercer', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill Road, Aberdeen AB25 2ZD, Scotland, UK.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Johnstone', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill Road, Aberdeen AB25 2ZD, Scotland, UK.'}]",Nutrients,['10.3390/nu12123710']
2332,33266266,The Preliminary Effects of a Multi-Recess School Intervention: Using Accelerometers to Measure Physical Activity Patterns in Elementary Children.,"This pilot study used accelerometers to investigate the effectiveness of a multiple recess school intervention on physical activity patterns in younger elementary children using a post-test only with nonequivalent groups design. First and second grade students ( N = 157) participating in a larger study, the LiiNK Project ® (Let's inspire innovation 'N Kids), wore accelerometers for the duration of the school day for two weeks to measure physical activity intensity and number of steps taken daily. Students attended either an intervention school ( N = 90), participating in four 15-min unstructured, outdoor recesses and one 15-min character development lesson daily, or a control school ( N = 67), participating in two 15-min unstructured, outdoor recesses daily and no character development program. The intervention students, grades 1 and 2, took more steps ( p < 0.001) and time spent in moderate ( p < 0.001) and vigorous ( p < 0.001) physical activity (MVPA) than the control school students. Intervention students averaged approximately 900 more steps per day than the control school students. These results show young children given 60 min of recess daily continue to increase physical activity patterns over those with 30 min of recess daily. Next steps are to evaluate if children demonstrate healthier body fat levels as a result of these higher patterns of MVPA daily.",2020,"The intervention students, grades 1 and 2, took more steps ( p < 0.001) and time spent in moderate ( p < 0.001) and vigorous ( p < 0.001) physical activity (MVPA) than the control school students.","[""First and second grade students ( N = 157) participating in a larger study, the LiiNK Project ® (Let's inspire innovation 'N Kids"", 'Elementary Children', 'younger elementary children using a post-test only with nonequivalent groups design', 'Students attended either an intervention school ( N = 90), participating in four 15-min unstructured']","['outdoor recesses and one 15-min character development lesson daily, or a control school ( N = 67), participating in two 15-min unstructured, outdoor recesses daily and no character development program', 'multiple recess school intervention', 'Multi-Recess School Intervention']","['physical activity patterns', 'physical activity (MVPA', 'time spent in moderate']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0031210', 'cui_str': 'Personality Development'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0147186,"The intervention students, grades 1 and 2, took more steps ( p < 0.001) and time spent in moderate ( p < 0.001) and vigorous ( p < 0.001) physical activity (MVPA) than the control school students.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farbo', 'Affiliation': 'Kinesiology Department, Texas Christian University, Fort Worth, TX 76129, USA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Maler', 'Affiliation': 'Kinesiology Department, Texas Christian University, Fort Worth, TX 76129, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Rhea', 'Affiliation': 'Kinesiology Department, Texas Christian University, Fort Worth, TX 76129, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17238919']
2333,33266190,Self-Selected Versus Standardised Warm-Ups; Physiological Response on 500 m Sprint Kayak Performance.,"This study investigated the effectiveness of a self-selected (SS) warm-up on 500 m sprint kayak performance (K500) compared to continuous (CON) and intermittent high intensity (INT)-type warm-ups. Twelve nationally ranked sprint kayakers (age 17.7 ± 2.3 years, mass 69.2 ± 10.8 kg) performed CON (15 min at the power at 2 m·mol -1 ), INT (10 min at 2 m·mol -1 , followed by 5 × 10 s sprints at 200% power at VO 2max with 50 s recovery at 55% power at VO 2max ), and SS (athlete's normal competition warm-up) warm-ups in a randomised order. After a five-minute passive recovery, K500 performance was determined on a kayak ergometer. Heart rate and blood lactate (BLa) were recorded before and immediately after each warm-up and K500 performance. Ratings of perceived exertion (RPE) were recorded at the end of the warm-up and K500. BLa, heart rate, and RPE were generally higher after the INT than CON and SS warm-ups ( p < 0.05). No differences in these parameters were found between the conditions for the time trial ( p > 0.05). RPE and changes in BLa and heart rate after the K500 were comparable. There were no differences in K500 performance after the CON, SS, or INT warm-ups. Applied practitioners can, therefore, attain similar performance independent of warm-up type.",2020,No differences in these parameters were found between the conditions for the time trial ( p > 0.05).,"['Twelve nationally ranked sprint kayakers (age 17.7 ± 2.3 years, mass 69.2 ± 10.8 kg) performed']","['CON', 'self-selected (SS) warm-up on 500 m sprint kayak performance (K500) compared to continuous (CON) and intermittent high intensity (INT)-type warm-ups']","['RPE and changes in BLa and heart rate', 'Ratings of perceived exertion (RPE', 'K500 performance', 'Heart rate and blood lactate (BLa', 'heart rate, and RPE']","[{'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517598', 'cui_str': '17.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0336847', 'cui_str': 'Kayak'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0574531', 'cui_str': 'Blackfoot language'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",,0.0291313,No differences in these parameters were found between the conditions for the time trial ( p > 0.05).,"[{'ForeName': 'Amelia F', 'Initials': 'AF', 'LastName': 'Dingley', 'Affiliation': 'Higher Education Sport, Hartpury University, Gloucester GL19 3BE, UK.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Willmott', 'Affiliation': 'School of Sport and Exercise Science, University of Lincoln, Lincoln LN6 7TS, UK.'}, {'ForeName': 'John F T', 'Initials': 'JFT', 'LastName': 'Fernandes', 'Affiliation': 'Higher Education Sport, Hartpury University, Gloucester GL19 3BE, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8120156']
2334,33266039,5-Year Follow-Up of a Telephone Intervention to Increase Fruit and Vegetable Consumption in Preschoolers: The ' Healthy Habits ' Cluster Randomised Trial.,"Little is known about the long-term impact of telephone-based interventions to improve child diet. This trial aimed to assess the long-term effectiveness (after 5 years) of a telephone-based parent intervention in increasing children's fruit and vegetable consumption. Parents of 3-5 year olds were recruited from 30 Australian preschools to participate in a cluster randomised controlled trial. Intervention parents received four, weekly, 30-min support calls aimed at modifying the home food environment. Control parents received printed materials. Consumption was assessed using the Fruit and Vegetable subscale of the Children's Dietary Questionnaire (F&V-CDQ) (children) and daily servings of fruit and vegetables (children and parents) via parent telephone interview. Of the 394 parents who completed baseline, 57% (99 intervention, 127 control) completed follow-up. After 5-years, higher intervention F&V-CDQ scores, bordering on significance, were found in complete-case (+1.1, p = 0.06) and sensitivity analyses (+1.1, p = 0.06). There was no difference in parent or child consumption of daily fruit servings. Complete-case analysis indicated significantly higher consumption of child vegetable servings (+0.5 servings; p = 0.02), which was not significant in sensitivity analysis (+0.5 servings; p = 0.10). This telephone-based parent intervention targeting the family food environment may yield promising improvements in child fruit and vegetable consumption over a 5-year period.",2020,"After 5-years, higher intervention F&V-CDQ scores, bordering on significance, were found in complete-case (+1.1, p = 0.06) and sensitivity analyses (+1.1, ","['Preschoolers', 'Parents of 3-5 year olds were recruited from 30 Australian preschools to participate in a cluster randomised controlled trial', ""children's fruit and vegetable consumption"", '394 parents who completed baseline, 57% (99 intervention, 127 control) completed follow-up']","['Telephone Intervention to Increase Fruit and Vegetable Consumption', 'telephone-based parent intervention']","['intervention F&V-CDQ scores', 'parent or child consumption of daily fruit servings', 'child fruit and vegetable consumption', ""Fruit and Vegetable subscale of the Children's Dietary Questionnaire (F&V-CDQ) (children) and daily servings of fruit and vegetables (children and parents) via parent telephone interview"", 'higher consumption of child vegetable servings']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",394.0,0.0798446,"After 5-years, higher intervention F&V-CDQ scores, bordering on significance, were found in complete-case (+1.1, p = 0.06) and sensitivity analyses (+1.1, ","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stacey', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Libby', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Serene', 'Initials': 'S', 'LastName': 'Yoong', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'Institute for Physical Activity and Nutrition, Deakin University, Geelong, VIC 3220, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'Hunter New England Population Health, Wallsend, New South Wales 2287, Australia.'}]",Nutrients,['10.3390/nu12123702']
2335,33266022,"Decrease in Mucosal IL17A, IFNγ and IL10 Expressions in Active Crohn's Disease Patients Treated with High-Dose Vitamin Alone or Combined with Infliximab.","BACKGROUND
Vitamin D treatment may reduce Crohn's disease (CD) activity by modulating the mucosal immune function. We investigated if high-dose vitamin D +/- infliximab modulated the mucosal cytokine expression in active CD.
METHODS
Forty CD patients were randomized into: infliximab + vitamin D; infliximab + placebo-vitamin D; placebo-infliximab + vitamin D or placebo-infliximab + placebo-vitamin D. Infliximab (5 mg/kg) and placebo-infliximab were administered at weeks 0, 2 and 6. Oral vitamin D was administered as bolus 200,000 international units (IU) per week 0 followed by 20,000 IU/day for 7 weeks or placebo. Endoscopy with biopsies was performed at weeks 0 and 7 where endoscopic activity was measured and mucosal mRNA cytokine expression was examined. C-reactive protein (CRP), fecal calprotectin and Harvey-Bradshaw Index (HBI) were measured at weeks 0, 2 and 6.
RESULTS
High-dose vitamin D treatment alone and combined with infliximab decreased the IL17A, IFNγ and IL10 expression. High-dose vitamin D alone did not significantly decrease the disease activity, CRP or calprotectin. Combined infliximab and vitamin D treatment was not clinically significantly superior to monotherapy with infliximab.
CONCLUSIONS
High-dose vitamin D as monotherapy and combined with infliximab decreases IL17A, IFNγ and IL-10 expression in mucosa within treatment groups. This did not induce a statistically significant decreased disease activity. EudraCT no.2013-000971-34.",2020,"RESULTS
High-dose vitamin D treatment alone and combined with infliximab decreased the IL17A, IFNγ and IL10 expression.",['Forty CD patients'],"['infliximab', 'vitamin D ', 'placebo', 'Vitamin Alone or Combined with Infliximab', 'infliximab + vitamin D; infliximab + placebo-vitamin D; placebo-infliximab + vitamin D or placebo-infliximab + placebo-vitamin D. Infliximab', 'Oral vitamin D', 'Combined infliximab and vitamin D', 'EudraCT', 'placebo-infliximab']","['Mucosal IL17A, IFNγ and IL10 Expressions', 'IL17A, IFNγ and IL-10 expression', 'disease activity', 'disease activity, CRP or calprotectin', 'C-reactive protein (CRP), fecal calprotectin and Harvey-Bradshaw Index (HBI', 'mucosal cytokine expression', 'IL17A, IFNγ and IL10 expression', 'mucosal mRNA cytokine expression']","[{'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}]",40.0,0.412477,"RESULTS
High-dose vitamin D treatment alone and combined with infliximab decreased the IL17A, IFNγ and IL10 expression.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Bendix', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Dige', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Søren Peter', 'Initials': 'SP', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Jens Frederik', 'Initials': 'JF', 'LastName': 'Dahlerup', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Bo Martin', 'Initials': 'BM', 'LastName': 'Bibby', 'Affiliation': 'Department of Public Health-Department of Biostatistics, Aarhus University, 8000 Aarhus, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Deleuran', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Agnholt', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, 8200 Aarhus, Denmark.'}]",Nutrients,['10.3390/nu12123699']
2336,33265969,Ganoderma lucidum Effects on Mood and Health-Related Quality of Life in Women with Fibromyalgia.,"Fibromyalgia syndrome is a chronic rheumatic disorder characterized by generalized and widespread musculoskeletal pain. It is associated with several secondary symptoms such as psychological and pain-specific distress, which can directly impact daily functioning and quality of life, like anxiety and depression. The Ganoderma lucidum (GL) mushroom seems to be able to improve fibromyalgia symptoms, including depression and pain. The purpose of the study is to evaluate the effects of GL on happiness, depression, satisfaction with life, and health-related quality of life in women with fibromyalgia. A double-blind, randomized placebo pilot trial was carried out, with one group taking 6 g/day of micro-milled GL carpophores for 6 weeks, during which the second group took a placebo. Our results did not show any statistically significant between-group differences, although a distinct trend of improved levels of happiness and satisfaction with life and reduced depression were evident at the end of treatment compared to the baseline in the GL group. However, due to the limitations of the study protocol, additional studies are necessary to confirm these findings.",2020,"Our results did not show any statistically significant between-group differences, although a distinct trend of improved levels of happiness and satisfaction with life and reduced depression were evident at the end of treatment compared to the baseline in the GL group.","['Women with Fibromyalgia', 'women with fibromyalgia']","['Ganoderma lucidum', 'placebo', 'GL']","['Mood and Health-Related Quality of Life', 'levels of happiness and satisfaction with life and reduced depression', 'happiness, depression, satisfaction with life, and health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0752326', 'cui_str': 'Lingzhi'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.111063,"Our results did not show any statistically significant between-group differences, although a distinct trend of improved levels of happiness and satisfaction with life and reduced depression were evident at the end of treatment compared to the baseline in the GL group.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pazzi', 'Affiliation': 'Health Economy Motricity and Education (HEME), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'José Carmelo', 'Initials': 'JC', 'LastName': 'Adsuar', 'Affiliation': 'Health Economy Motricity and Education (HEME), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Domínguez-Muñoz', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'García-Gordillo', 'Affiliation': 'Facultad de Administración y Negocios, Universidad Autónoma de Chile, 3467987 Sede Talca, Chile.'}, {'ForeName': 'Narcis', 'Initials': 'N', 'LastName': 'Gusi', 'Affiliation': 'Physical Activity and Quality of Life Research Group (AFYCAV), Faculty of Sport Science, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943 Madrid, Spain.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8040520']
2337,33265967,Association of the Modified Mediterranean Diet Score (mMDS) with Anthropometric and Biochemical Indices in US Career Firefighters.,"The Mediterranean diet is associated with multiple health benefits, and the modified Mediterranean Diet Score (mMDS) has been previously validated as a measure of Mediterranean diet adherence. The aim of this study was to examine associations between the mMDS and anthropometric indices, blood pressure, and biochemical parameters in a sample of career firefighters. The participants were from Indiana Fire Departments, taking part in the ""Feeding America's Bravest"" study, a cluster-randomized controlled trial that aimed to assess the efficacy of a Mediterranean diet intervention. We measured Mediterranean diet adherence using the mMDS. Anthropometric, blood pressure, and biochemical measurements were also collected. Univariate and multivariate linear regression models were used. In unadjusted analyses, many expected favorable associations between the mMDS and cardiovascular disease risk factors were found among the 460 firefighters. After adjustment for age, gender, ethnicity, physical activity, and smoking, a unitary increase in the mMDS remained associated with a decrease of the total cholesterol/HDL ratio (β-coefficient -0.028, p = 0.002) and an increase of HDL-cholesterol (β-coefficient 0.254, p = 0.004). In conclusion, greater adherence to the Mediterranean diet was associated with markers of decreased cardiometabolic risk. The mMDS score is a valid instrument for measuring adherence to the Mediterranean diet and may have additional utility in research and clinical practice.",2020,The mMDS score is a valid instrument for measuring adherence to the Mediterranean diet and may have additional utility in research and clinical practice.,[],['Mediterranean diet intervention'],"['Anthropometric, blood pressure, and biochemical measurements', 'cardiometabolic risk', 'total cholesterol/HDL ratio', 'HDL-cholesterol', 'Mediterranean diet adherence', 'mMDS and anthropometric indices, blood pressure, and biochemical parameters']",[],"[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2938855', 'cui_str': 'Total cholesterol:HDL ratio measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0236261,The mMDS score is a valid instrument for measuring adherence to the Mediterranean diet and may have additional utility in research and clinical practice.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Romanidou', 'Affiliation': 'Department of Medical Statistics, Medical Faculty, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Grigorios', 'Initials': 'G', 'LastName': 'Tripsianis', 'Affiliation': 'Department of Medical Statistics, Medical Faculty, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Maria Soledad', 'Initials': 'MS', 'LastName': 'Hershey', 'Affiliation': 'Department of Preventive Medicine and Public Health, Navarra Institute for Health Research, University of Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Sotos-Prieto', 'Affiliation': 'Department of Environmental Health, T.H. Chan School of Public Health, Harvard University, Boston, MA 02215, USA.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Christophi', 'Affiliation': 'Department of Environmental Health, T.H. Chan School of Public Health, Harvard University, Boston, MA 02215, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Moffatt', 'Affiliation': 'National Institute for Public Safety Health, IN 324 E New York Street, Indianapolis, IN 46204, USA.'}, {'ForeName': 'Theodoros C', 'Initials': 'TC', 'LastName': 'Constantinidis', 'Affiliation': 'Laboratory of Hygiene and Environmental Protection, Medical School, Democritus University of Thrace, 68100 Alexandroupolis, Greece.'}, {'ForeName': 'Stefanos N', 'Initials': 'SN', 'LastName': 'Kales', 'Affiliation': 'Department of Environmental Health, T.H. Chan School of Public Health, Harvard University, Boston, MA 02215, USA.'}]",Nutrients,['10.3390/nu12123693']
2338,33265698,Information Geometry of Randomized Quantum State Tomography.,"Suppose that a d -dimensional Hilbert space H ≃ C d admits a full set of mutually unbiased bases | 1 ( a ) 〉 , ⋯ , | d ( a ) 〉 , where a = 1 , ⋯ , d + 1 . A randomized quantum state tomography is a scheme for estimating an unknown quantum state on H through iterative applications of measurements M ( a ) = | 1 ( a ) 〉 〈 1 ( a ) | , ⋯ , | d ( a ) 〉 〈 d ( a ) | for a = 1 , ⋯ , d + 1 , where the numbers of applications of these measurements are random variables. We show that the space of the resulting probability distributions enjoys a mutually orthogonal dualistic foliation structure, which provides us with a simple geometrical insight into the maximum likelihood method for the quantum state tomography.",2018,"We show that the space of the resulting probability distributions enjoys a mutually orthogonal dualistic foliation structure, which provides us with a simple geometrical insight into the maximum likelihood method for the quantum state tomography.",[],[],[],[],[],[],,0.0470094,"We show that the space of the resulting probability distributions enjoys a mutually orthogonal dualistic foliation structure, which provides us with a simple geometrical insight into the maximum likelihood method for the quantum state tomography.","[{'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Mathematics, Osaka University, Toyonaka, Osaka 560-0043, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Yamagata', 'Affiliation': 'Graduate School of Informatics and Engineering, The University of Electro-Communications, Chofu, Tokyo 182-8585, Japan.'}]","Entropy (Basel, Switzerland)",['10.3390/e20080609']
2339,33265085,Expression changes of IL-17 in zoledronic acid combined with PVP technology in the treatment of postmenopausal osteoporotic vertebral compression fracture and its predictive value of relapse.,"OBJECTIVE
To investigate the expression of interleukin-17 (IL-17) in zoledronic acid combined with PVP technology for patients with postmenopausal osteoporotic vertebral compression fracture (OVCF) and its predictive value for relapse.
METHODS
101 OVCF patients treated in our hospital from April 2013 to January 2015 were collected as a research group and treated by zoledronic acid combined with PVP technology. 80 healthy people with physical examination were assigned to the control group. ELISA was used to detect the expression of IL-17 in serum of the two groups. Patients were followed up for 2 years. The expression of IL-17 before treatment was compared between patients with relapse and patients without relapse. The predictive value of IL-17 in relapse was drawn according to ROC curve.
RESULTS
Before treatment, the expression of IL-17 in the research group increased significantly (p<0.05). After treatment, the expression of IL-17 in the research group decreased significantly (p<0.05). The level of IL-17 in patients with relapse was significantly higher than that in patients without relapse (p<0.05).
CONCLUSIONS
IL-17 is highly expressed in postmenopausal patients with osteoporotic vertebral compression fracture and is expected to be a potential predictor of relapse in postmenopausal patients with OVCF.",2020,"Before treatment, the expression of IL-17 in the research group increased significantly (p<0.05).","['postmenopausal patients with osteoporotic vertebral compression fracture', 'patients with postmenopausal osteoporotic vertebral compression fracture (OVCF', '80 healthy people with physical examination', 'postmenopausal patients with OVCF', '101 OVCF patients treated in our hospital from April 2013 to January 2015']","['ELISA', 'IL-17', 'zoledronic acid combined with PVP technology']","['level of IL-17', 'postmenopausal osteoporotic vertebral compression fracture', 'expression of IL-17']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",80.0,0.0244782,"Before treatment, the expression of IL-17 in the research group increased significantly (p<0.05).","[{'ForeName': 'Linsong', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Blood Transfusion, The First Affiliated Hospital of Xinjiang Medical University, P.R. China.'}, {'ForeName': 'Shaxika', 'Initials': 'S', 'LastName': 'Nazierhan', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}, {'ForeName': 'Dilimulati', 'Initials': 'D', 'LastName': 'Aikeremu', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}, {'ForeName': 'Wuqikun', 'Initials': 'W', 'LastName': 'Alimasi', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}, {'ForeName': 'Kuo', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}, {'ForeName': 'Waresijiang', 'Initials': 'W', 'LastName': 'Niyazi', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Spine Surgery Department of Orthopedic Center, People's Hospital of Xinjiang Uygur Autonomous Region, P.R. China.""}]",Journal of musculoskeletal & neuronal interactions,[]
2340,33265084,Comparison of the clinical effect of DHS and PFNA on senile osteoporotic fracture and their significance of changes in BALP expression level.,"OBJECTIVE
To investigate the clinical effects of dynamic hip screw (DHS) and proximal femoral nail anti-rotation (PFNA) on senile osteoporosis patients and their effects on the expression level of bone-specific alkaline phosphatase (BALP).
METHODS
116 elderly patients with osteoporotic fracture were divided into DHS group (n=67) and PFNA group (n=49). BALP values were measured by ELISA before operation and 30 days after operation.
RESULTS
The operation time, the bleeding volume, and the weight-bearing time of PFNA group was shorter than DHS group (p<0.05); the dominant blood loss and occult blood loss in PFNA group were less than those in DHS group (p<0.05); the healing time and detumescence time, the complications of PFNA group was fewer than the DHS group (p<0.05). The ten-meter walking speed and the five sitting tests in PFNA group were shorter than that in DHS group (p<0.05); the excellent and good rate and Harris score in PFNA group were higher than those in DHS group (p<0.05). The expression of BALP in PFNA group was lower than that in DHS group (p<0.05).
CONCLUSION
PFNA surgery has less trauma, fewer complications, more optimistic postoperative healing and recovery degree, and is more conducive to the reduction of BALP expression level.",2020,"The expression of BALP in PFNA group was lower than that in DHS group (p<0.05).
","['116 elderly patients with osteoporotic fracture', 'senile osteoporosis patients']","['dynamic hip screw (DHS) and proximal femoral nail anti-rotation (PFNA', 'DHS and PFNA', 'PFNA', 'DHS']","['BALP expression level', 'healing time and detumescence time', 'excellent and good rate and Harris score', 'expression of BALP', 'operation time, the bleeding volume, and the weight-bearing time', 'blood loss and occult blood loss', 'senile osteoporotic fracture', 'expression level of bone-specific alkaline phosphatase (BALP', 'BALP values']","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0029459', 'cui_str': 'Senile osteoporosis'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0028792', 'cui_str': 'Occult blood screening'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",116.0,0.0117698,"The expression of BALP in PFNA group was lower than that in DHS group (p<0.05).
","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Ouyang', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Yunzhi', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Sha', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}, {'ForeName': 'Yiqi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedic Surgery, Affiliated Xuzhou Hospital of Jiangsu University, Xuzhou 3rd Hospital, Xuzhou, China.'}]",Journal of musculoskeletal & neuronal interactions,[]
2341,33265083,Immediate effect of patellar kinesiology tape application on quadriceps peak moment following muscle fatigue: A randomized controlled study.,"OBJECTIVE
To investigate the immediate effect of horseshoe taping for patellar superior and inferior gliding (HTPSG and HTPIG, respectively) using kinesiology tape on the peak moment of fatigued quadriceps.
METHODS
Twenty-eight adults were divided into the HTPSG (experimental) and HTPIG (control) groups. The peak moment of the dominant quadriceps of the participants was measured using Biodex System 4 prior to the experiment and after inducing quadriceps fatigue. The peak moment of the quadriceps was measured after separate application of HTPSG and HTPIG using kinesiology tape.
RESULTS
After kinesiology tape application, the peak moment of the quadriceps muscle was significantly increased in both groups (p<.05); however, the peak moment of the fatigued quadriceps muscle was significantly higher in the HTPSG group than in the HTPIG group (p<.05).
CONCLUSIONS
The application of HTPSG using kinesiology tape would more be helpful for immediate recovery after exercise-induced quadriceps fatigue.",2020,"After kinesiology tape application, the peak moment of the quadriceps muscle was significantly increased in both groups (p<.05); however, the peak moment of the fatigued quadriceps muscle was significantly higher in the HTPSG group than in the HTPIG group (p<.05).
","['Twenty-eight adults', 'muscle fatigue']","['HTPSG', 'HTPIG', 'horseshoe taping for patellar superior and inferior gliding (HTPSG and HTPIG, respectively) using kinesiology tape', 'HTPSG (experimental) and HTPIG (control', 'patellar kinesiology tape application']","['quadriceps peak moment', 'peak moment of the fatigued quadriceps muscle', 'peak moment of the quadriceps muscle', 'peak moment of the quadriceps']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}]","[{'cui': 'C0444766', 'cui_str': 'Horseshoe'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",28.0,0.0249343,"After kinesiology tape application, the peak moment of the quadriceps muscle was significantly increased in both groups (p<.05); however, the peak moment of the fatigued quadriceps muscle was significantly higher in the HTPSG group than in the HTPIG group (p<.05).
","[{'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Son', 'Affiliation': 'Department of Biomechanical Health Science, Graduate School, Dong-Eui University.'}, {'ForeName': 'Jung-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Nursing and Healthcare Sciences and Human Ecology, Dong-Eui University, Busan, Republic of Korea.'}, {'ForeName': 'Im-Rak', 'Initials': 'IR', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Therapy Team, Sports Exercise Therapy Center, Good Samsun Hospital, Republic of Korea.'}]",Journal of musculoskeletal & neuronal interactions,[]
2342,33265082,Effect of balance taping on trunk stabilizer muscles for back extensor muscle endurance: A randomized controlled study.,"OBJECTIVE
The purpose of this study was to investigate the difference in back extensor muscle endurance before and after kinesiology tape application to all back stabilizer muscles and to the erector spinae alone.
METHODS
We assessed 32 adults (16 men and 16 women), randomly divided into two groups. In the erector spinae taping (EST) group, kinesiology tape was applied only to the erector spinae, and in the total muscle taping (TMT) group, kinesiology tape was applied to the erector spinae, latissimus dorsi, lower trapezius, internal oblique abdominis, and external oblique abdominis.
RESULTS
Both groups showed significant difference in terms of back extensor muscle endurance after kinesiology tape application (p<0.05). Between-group comparison revealed that the TMT group had more back extensor muscle endurance than the EST group (p<0.05) after kinesiology tape application.
CONCLUSIONS
These findings indicate that, to improve back extensor muscle endurance, kinesiology tape should be applied to all back stabilizer muscles, rather than to the erector spinae muscles alone.",2020,Both groups showed significant difference in terms of back extensor muscle endurance after kinesiology tape application (p<0.05).,"['32 adults (16 men and 16 women', 'back extensor muscle endurance']","['TMT', 'EST', 'erector spinae taping (EST', 'balance taping', 'total muscle taping (TMT) group, kinesiology tape']",['back extensor muscle endurance'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",32.0,0.0118175,Both groups showed significant difference in terms of back extensor muscle endurance after kinesiology tape application (p<0.05).,"[{'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Biomechanical Health Science, Graduate School, Dong-Eui University.'}, {'ForeName': 'Im-Rak', 'Initials': 'IR', 'LastName': 'Choi', 'Affiliation': 'Department of Rehabilitation Therapy Team, Sports Exercise Therapy Center, Good Samsun Hospital.'}, {'ForeName': 'Jung-Hoon', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, College of Nursing and Healthcare Sciences and Human Ecology, Dong-Eui University, Busan, Republic of Korea.'}]",Journal of musculoskeletal & neuronal interactions,[]
2343,33264825,Effect of Finerenone on Chronic Kidney Disease Outcomes in Type 2 Diabetes.,"BACKGROUND
Finerenone, a nonsteroidal, selective mineralocorticoid receptor antagonist, reduced albuminuria in short-term trials involving patients with chronic kidney disease (CKD) and type 2 diabetes. However, its long-term effects on kidney and cardiovascular outcomes are unknown.
METHODS
In this double-blind trial, we randomly assigned 5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive finerenone or placebo. Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m 2 of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m 2 . All the patients were treated with renin-angiotensin system blockade that had been adjusted before randomization to the maximum dose on the manufacturer's label that did not cause unacceptable side effects. The primary composite outcome, assessed in a time-to-event analysis, was kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes. The key secondary composite outcome, also assessed in a time-to-event analysis, was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
RESULTS
During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001). A key secondary outcome event occurred in 367 patients (13.0%) and 420 patients (14.8%) in the respective groups (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P = 0.03). Overall, the frequency of adverse events was similar in the two groups. The incidence of hyperkalemia-related discontinuation of the trial regimen was higher with finerenone than with placebo (2.3% and 0.9%, respectively).
CONCLUSIONS
In patients with CKD and type 2 diabetes, treatment with finerenone resulted in lower risks of CKD progression and cardiovascular events than placebo. (Funded by Bayer; FIDELIO-DKD ClinicalTrials.gov number, NCT02540993.).",2020,"During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001).","['patients with chronic kidney disease (CKD) and type 2 diabetes', 'Eligible patients had a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300, an estimated glomerular filtration rate (eGFR) of 25 to less than 60 ml per minute per 1.73 m 2 of body-surface area, and diabetic retinopathy, or they had a urinary albumin-to-creatinine ratio of 300 to 5000 and an eGFR of 25 to less than 75 ml per minute per 1.73 m 2 ', '5734 patients with CKD and type 2 diabetes in a 1:1 ratio to receive', 'Type 2 Diabetes']","['placebo', 'renin-angiotensin system blockade', 'finerenone', 'finerenone or placebo', 'Finerenone']","['Chronic Kidney Disease Outcomes', 'time-to-event analysis, was death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure', 'frequency of adverse events', 'incidence of hyperkalemia-related discontinuation', 'lower risks of CKD progression and cardiovascular events', 'time-to-event analysis, was kidney failure, a sustained decrease of at least 40% in the eGFR from baseline, or death from renal causes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0005902', 'cui_str': 'Body surface area'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C4045511', 'cui_str': 'finerenone'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}]",5734.0,0.692076,"During a median follow-up of 2.6 years, a primary outcome event occurred in 504 of 2833 patients (17.8%) in the finerenone group and 600 of 2841 patients (21.1%) in the placebo group (hazard ratio, 0.82; 95% confidence interval [CI], 0.73 to 0.93; P = 0.001).","[{'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Ruilope', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kolkhof', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nowack', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schloemer', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Joseph', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'From the Department of Medicine, University of Chicago Medicine, Chicago (G.L.B.); the Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis (R.A.); the Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin (S.D.A.), and Research and Development, Statistics and Data Insights (P.S.), and Cardiology and Nephrology Clinical Development (A.J.), Bayer, Berlin, and Research and Development, Preclinical Research Cardiovascular (P.K.) and Clinical Development Operations (C.N.), Bayer, Wuppertal - both in Germany; the Department of Medicine, University of Michigan School of Medicine, Ann Arbor (B.P.); the Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research i+12, Centro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Hospital Universitario 12 de Octubre, and the Faculty of Sport Sciences, European University of Madrid - all in Madrid (L.M.R.); Steno Diabetes Center Copenhagen, Gentofte, and the Department of Clinical Medicine, University of Copenhagen, Copenhagen - both in Denmark (P.R.); and the National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens (G.F.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2025845']
2344,33264819,Effect of Adjunctive Pimavanserin on Sleep/Wakefulness in Patients With Major Depressive Disorder: Secondary Analysis From CLARITY.,"OBJECTIVE
This was an analysis of the effect of pimavanserin, a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist, on dysregulated sleep in patients with major depressive disorder (MDD) by DSM-5 criteria and an inadequate antidepressant response.
METHODS
For this analysis of CLARITY, a phase 2 study of adjunctive pimavanserin (N = 207) conducted between December 2016 and October 2018, sleep/wakefulness disturbances were measured with the 17-item Hamilton Depression Rating Scale (HDRS₁₇) insomnia items (sum of items 4, 5, and 6) and the Karolinska Sleepiness Scale (KSS). Outcomes included change from baseline in HDRS₁₇ insomnia factor score and KSS score, correlation between the HDRS₁₇ insomnia factor score and KSS score, and change from baseline in the Sheehan Disability Scale (SDS) total score and Unproductive Days subscore in patients with a baseline KSS score ≥ 6.
RESULTS
At baseline, HDRS₁₇ insomnia factor score ≥ 3 occurred in 76% of patients receiving placebo and 85% of patients receiving pimavanserin. The overall least squares (LS) mean weighted difference (SE) was -0.5 (0.32) with a 95% CI of -1.2 to 0.1 (P = .088) at week 5. Improvement was observed with pimavanserin versus placebo at weeks 2, 3, and 4, with effect sizes (ESs) of 0.370 to 0.524 (P < .05). For KSS score, the LS mean difference (SE) at week 5 was -1.1 (0.30) (95% CI, -1.7 to -0.5; P = .0003; ES = 0.627) for pimavanserin versus placebo. Among those with a KSS score ≥ 6 at baseline (n = 120 placebo and n = 42 pimavanserin), the LS mean difference (SE) in the mean SDS score at week 5 was -1.1 (0.46) (95% CI, -2.0 to -0.2; P = .019; ES = 0.442) for pimavanserin versus placebo.
CONCLUSIONS
Adjunctive pimavanserin significantly improved sleep/wakefulness disturbance during treatment of MDD, an improvement that was associated with greater improvement in function.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03018340.",2020,"Improvement was observed with pimavanserin versus placebo at weeks 2, 3, and 4, with effect sizes (ESs) of 0.370 to 0.524 (P < .05).","['patients with major depressive disorder (MDD) by DSM-5 criteria and an inadequate antidepressant response', 'Patients With Major Depressive Disorder']","['pimavanserin', 'placebo', 'Adjunctive Pimavanserin', 'pimavanserin, a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist', 'pimavanserin versus placebo']","['overall least squares (LS) mean weighted difference (SE', 'HDRS₁₇ insomnia factor score ≥ 3', 'HDRS₁₇ insomnia factor score and KSS score, correlation between the HDRS₁₇ insomnia factor score and KSS score, and change from baseline in the Sheehan Disability Scale (SDS) total score and Unproductive Days subscore', '17-item Hamilton Depression Rating Scale (HDRS₁₇) insomnia items (sum of items 4, 5, and 6) and the Karolinska Sleepiness Scale (KSS', 'function', 'sleep/wakefulness disturbance', 'mean SDS score', 'Sleep/Wakefulness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}]","[{'cui': 'C1722267', 'cui_str': 'pimavanserin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0439850', 'cui_str': 'Inverse'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}]",,0.268383,"Improvement was observed with pimavanserin versus placebo at weeks 2, 3, and 4, with effect sizes (ESs) of 0.370 to 0.524 (P < .05).","[{'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY 10029. manish.jha@mssm.edu.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc, San Diego, California, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20m13425']
2345,33264811,Efficacy and safety of cold vs hot snare polypectomy for small (5-9 mm) colorectal polyps: a multicenter randomized controlled trial.,"BACKGROUND AND AIMS
Currently available resection techniques for small polyps include cold snare polypectomy (CSP) and hot snare polypectomy (HSP). We aimed to compare CSP vs HSP in 5-9 mm polyps in terms of complete resection and adverse events rates.
METHODS
Multicenter, randomized trial conducted in 7 Spanish centers between February-November 2019. Patients with ≥1 5-9mm polyp were randomized to CSP or HSP, regardless of morphology or pit pattern. After polyp removal, two marginal biopsies were submitted to a single pathologist blind to polyp histology. Complete resection was defined as the only finding of normal mucosa or burn artifacts in the biopsies. Abdominal pain was only assessed in patients without <5mm or >9mm polyps.
RESULTS
A total of 496 subjects were randomized; 237 (394 polyps) to CSP and 259 (397 polyps) to HSP. Complete polypectomy rates were 92.5% with CSP and 94% with HSP (difference 1.5%, 95%CI: 4.9% to -1.9%). Intraprocedural bleeding appeared in 3 (0.8%) CSPs and 7 (1.8%) HSPs (p=0.34). One (0.3%) lesion per group presented delayed hemorrhage. Post-colonoscopy abdominal pain presented similarly in both groups 1 hour after the procedure (18.8% in CSP vs 18.4% in HSP), but, after 5 hours, it was higher in HSP group (5.9% vs 16,5%, p=0.02). CSP presented a higher proportion of asymptomatic patients 24h after the procedure than HSP, 97% vs 86.4% (p=0.01).
CONCLUSIONS
We observed no differences in complete resection and bleeding rates between CSP and HSP. CSP reduces the intensity and duration of post-colonoscopy abdominal pain (ClinicalTrials.gov number: NCT03783156).",2020,"CSP presented a higher proportion of asymptomatic patients 24h after the procedure than HSP, 97% vs 86.4% (p=0.01).
","['496 subjects were randomized; 237 (394 polyps) to CSP and 259 (397 polyps) to', 'small polyps include cold snare polypectomy (CSP) and hot snare polypectomy (HSP', 'small (5-9 mm) colorectal polyps', '7 Spanish centers between February-November 2019', 'Patients with ≥1 5-9mm polyp']","['cold vs hot snare polypectomy', 'HSP', 'CSP', 'CSP or HSP', 'CSP vs HSP']","['Efficacy and safety', 'delayed hemorrhage', 'Intraprocedural bleeding', 'Complete polypectomy rates', 'complete resection and bleeding rates', 'Abdominal pain', 'intensity and duration of post-colonoscopy abdominal pain']","[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0183362', 'cui_str': 'Snare'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0183362', 'cui_str': 'Snare'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1446340', 'cui_str': 'Cold snare'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]",496.0,0.40243,"CSP presented a higher proportion of asymptomatic patients 24h after the procedure than HSP, 97% vs 86.4% (p=0.01).
","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'De Benito Sanz', 'Affiliation': 'Hospital Universitario Rio Hortega, Gastroenterology department, Valladolid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Hernández', 'Affiliation': 'Hospital Univeritario de Móstoles, Servicio de Aparato Digestivo, Móstoles, Spain.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'García-Martínez', 'Affiliation': 'Hospital Universitario de Salamanca, Pathology department, Salamanca, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Diez Redondo', 'Affiliation': 'hospital universitario rio hortega, digestive diseases, valladolid, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Joao Matías', 'Affiliation': 'Hospital Universitario de Salamanca, Gastroenterology department, Salamanca, Spain.'}, {'ForeName': 'Jesus M', 'Initials': 'JM', 'LastName': 'Gonzalez-Santiago', 'Affiliation': 'Hospital Universitario de Salamanca, Gastroenterology, Salamanca, Spain.'}, {'ForeName': 'Mercedes Ibañez', 'Initials': 'MI', 'LastName': 'Garcia', 'Affiliation': 'Hospital de Medina del Campo, digestivo, Medina del Camp, Spain.'}, {'ForeName': 'Henar', 'Initials': 'H', 'LastName': 'Nuñez Rodriguez', 'Affiliation': 'University Hospital ""Rio Hortega"", Gastroenterology department, valladolid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Cimavilla', 'Affiliation': 'Hospital Rio Carrion, Gastroenterology Department, Palencia, Spain.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Tafur Sánchez', 'Affiliation': 'Hospital de Medina del Campo, Gastroenterology department, Medina del Camp, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mata', 'Affiliation': 'Hospital de Medina del Campo, Gastroenterology department, Medina del Camp, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Guardiola Arévalo', 'Affiliation': 'Hospital Universitario de Fuenlabrada, Gastroenterology, Fuenlabrada, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Feito', 'Affiliation': 'Hospital Universitario de Salamanca, Pathology department, Salamanca, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'García-Alonso', 'Affiliation': 'Hospital Universitario Rio Hortega, Gastroenterology department, Valladolid, Spain.'}]",Endoscopy,['10.1055/a-1327-8357']
2346,33264808,Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE
This study aimed to evaluate the effect of a novel antimicrobial dressing on patient satisfaction and health-related quality of life (HRQoL) following a cesarean delivery.
STUDY DESIGN
This was an open-label, single-center, two-arm randomized controlled trial. This study was done at the tertiary center, maternal unit, Galveston, TX. Pregnant women with body mass indices ≥35 kg/m2 were screened for eligibility. Women were randomized to ReliaTect Post-Op Dressing (RELIATECT) or standard wound dressing (STANDARD). Primary outcome was patient satisfaction and HRQoL using validated questionnaires. Secondary outcomes were provider satisfaction, surgical site infection (SSI) rates, and wound complications.
RESULTS
In total, 160 women were randomized. Population characteristics were not significant among groups. RELIATECT dressing group had an overall higher score of satisfaction and HRQoL compared with STANDARD group. Women in the RELIATECT group reported less incision odor and incisional pain. Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep. Providers reported that the RELIATECT dressing allowed better assessment of the surgical incision site, allowed patients to shower early, and did observe less wound dressing leakage. No differences were found in other secondary end points.
CONCLUSION
Postcesarean RELIATECT dressing for wound care in pregnant women with obesity had better patient and provider satisfaction as well as better HRQoL scores. Further, level 1 evidence is needed to assess its impact on SSI rates and wound complication, as this trial was not powered to accomplish this goal.
KEY POINTS
· This study was conducted to evaluate RELIATECT on patient satisfaction and HRQoL following a cesarean.. · Post-cesarean RELIATECT dressing for wound care had better HRQoL and patient and provider satisfaction scores.. · This is the first randomized controlled trial evaluating RELIATECT dressing in obese pregnant women undergoing cesarean section..",2020,"Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep.","['pregnant women with obesity', 'Pregnant women with body mass indices ≥35', '160 women were randomized', 'Undergoing Cesarean Delivery', 'Obese Women', 'obese pregnant women undergoing cesarean section']","['ReliaTect Post-Op Dressing (RELIATECT) or standard wound dressing', 'novel antimicrobial dressing', 'Postcesarean RELIATECT dressing', 'Antimicrobial Dressing versus Standard Dressing']","['patient satisfaction and health-related quality of life (HRQoL', 'provider satisfaction, surgical site infection (SSI) rates, and wound complications', 'better daily activities, self-esteem, personal hygiene, body image, and sleep', 'wound dressing leakage', 'score of satisfaction and HRQoL', 'patient satisfaction and HRQoL using validated questionnaires', 'incision odor and incisional pain', 'SSI rates and wound complication']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0564673', 'cui_str': 'Personal hygiene activities'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0178388', 'cui_str': 'Dressing of wound'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}]",160.0,0.300964,"Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep.","[{'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Saad', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Salazar', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Allen', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The University of Texas Medical Branch, Galveston, Texas.'}]",American journal of perinatology,['10.1055/s-0040-1721112']
2347,33264686,"Metabolic and performance responses of male runners wearing 3 types of footwear: Nike Vaporfly 4%, Saucony Endorphin racing flats, and their own shoes.","OBJECTIVE
We compared running economy (RE) and 3-km time-trial (TT) variables of runners wearing Nike Vaporfly 4% (VP4), Saucony Endorphin lightweight racing flats (FLAT), and their habitual running (OWN) footwear.
METHODS
Eighteen male recreational runners (age: 33.5 ± 11.9 year (mean ± SD), peak oxygen uptake (VO 2peak ): 55.8 ± 4.4 mL/kg•min) attended 4 sessions ∼7 days apart. The first session consisted of a VO 2peak test to inform subsequent RE speeds set at 60%, 70%, and 80% of the speed eliciting VO 2peak . In subsequent sessions, treadmill RE and 3-km TTs were assessed in the 3 footwear conditions in a randomized, counterbalanced crossover design.
RESULTS
Oxygen consumption (mL/kg•min) was lesser in VP4 (from 4.3% to 4.4%, p ≤ 0.002) and FLAT (from 2.7% to 3.4%, p ≤ 0.092) vs. OWN across intensities, with a non-significant difference between VP4 and FLAT (1.0%-1.7%, p ≥ 0.292). Findings related to energy cost (W/kg) and energetics cost of transport (J/kg•m) were comparable. VP4 3-km TT performance (11:07.6 ± 0:56.6 mm:ss) was enhanced vs. OWN by 16.6 s (2.4%, p = 0.005) and FLAT by 13.0 s (1.8%, p = 0.032). Times between OWN and FLAT (0.5%, p = 0.747) were similar. Most runners (n = 11, 61%) ran their fastest TT in VP4.
CONCLUSIONS
Overall, VP4 improved laboratory-based RE measures in male recreational runners at relative speeds compared to OWN, but improvements in VP4 were not significant vs. FLAT. More runners exhibited better treadmill TT performances in VP4 (61%) vs. FLAT (22%) and OWN (17%). The variability in RE (-10.3% to 13.3%) and TT (-4.7% to 9.3%) improvements suggests that responses to different types of shoes are individualised and warrant further investigation.",2020,"RESULTS
Oxygen consumption (mL/kg•min) was lesser in VP4 (from 4.3% to 4.4%, p ≤ 0.002) and FLAT (from 2.7% to 3.4%, p ≤ 0.092) vs. OWN across intensities, with a non-significant difference between VP4 and FLAT (1.0%-1.7%, p ≥ 0.292).","['male recreational runners', 'male runners wearing 3 types of footwear: Nike Vaporfly 4%, Saucony Endorphin racing flats, and their own shoes', 'runners wearing Nike Vaporfly 4% (VP4), Saucony Endorphin lightweight racing flats (FLAT), and their habitual running (OWN) footwear', 'Eighteen male recreational runners (age: 33.5 ± 11.9 year (mean ± SD), peak oxygen uptake (VO 2peak ): 55.8 ± 4.4']",[],"['VP4 3-km TT performance', 'VP4', 'Overall, VP4 improved laboratory-based RE measures', 'energy cost (W/kg) and energetics cost of transport (J/kg•m', 'FLAT', 'Oxygen consumption', 'variability in RE', 'Metabolic and performance responses', 'treadmill TT performances']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0336894', 'cui_str': 'Footwear'}, {'cui': 'C0014242', 'cui_str': 'Endorphin'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C4517761', 'cui_str': '4.4'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]",18.0,0.14862,"RESULTS
Oxygen consumption (mL/kg•min) was lesser in VP4 (from 4.3% to 4.4%, p ≤ 0.002) and FLAT (from 2.7% to 3.4%, p ≤ 0.092) vs. OWN across intensities, with a non-significant difference between VP4 and FLAT (1.0%-1.7%, p ≥ 0.292).","[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hébert-Losier', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand. Electronic address: kim.hebert-losier@waikato.ac.nz.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Finlayson', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Driller', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand; Sport and Exercise Science, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Victoria 3086, Australia.'}, {'ForeName': 'Blaise', 'Initials': 'B', 'LastName': 'Dubois', 'Affiliation': 'Research & Development, the Running Clinic, Lac-Beauport, Québec G3B 2J8, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Esculier', 'Affiliation': 'Research & Development, the Running Clinic, Lac-Beauport, Québec G3B 2J8, Canada.'}, {'ForeName': 'Christopher Martyn', 'Initials': 'CM', 'LastName': 'Beaven', 'Affiliation': 'Division of Health, Engineering, Computing and Science, Te Huataki Waiora School of Health, University of Waikato, Mount Maunganui, Tauranga 3116, New Zealand.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.11.012']
2348,33264578,Toward a New Evidence-Based Fitting Paradigm for Over-the-Counter Hearing Aids.,"Purpose This dual-aim study was intended to develop and validate a new fitting paradigm for over-the-counter (OTC) hearing aids. Aim 1 was undertaken to create a limited set of evidence-based preconfigured gain-frequency responses (""presets"") for use in OTC devices. Aim 2 tested the efficacy of the presets relative to best-practice verification and determined the best method(s) for older adults to self-select amplification from the set. Method In Aim 1, audiometry data from 267 older adults with mild-to-moderate sensorineural hearing loss were obtained from the National Health and Nutrition Examination Survey database. Using these data and the National Acoustic Laboratories-Non-Linear 2 (NAL-NL2) prescriptive formula, a set of four presets were created that can fit a large percentage of older Americans with presbycusis. In Aim 2, 37 older adults with hearing loss used five methods to select presets. The selection methods were select-by-audiogram, select-by-self-test, select-by-trying, select-by-questionnaire, and random assignment. Using a crossover design, each participant completed speech recognition testing and sound quality ratings in quiet and noise for all selection methods and a verified NAL-NL2 condition. Results The set of presets can fit 67.9% of older Americans with mild-to-moderate hearing loss (Aim 1). Controlling for hearing thresholds and sound quality ratings, liner mixed-effects models indicated that speech recognition scores for select-by-audiogram, select-by-self-test, and select-by-trying were not statistically different from the NAL-NL2 condition. Statistical analysis indicated that select-by-self-test produced outcomes most consistent with individual outcomes for the NAL-NL2 condition (Aim 2). Conclusion This newly developed fitting paradigm may provide efficacy comparable to best-practice verification and could be used in OTC hearing aids.",2020,Statistical analysis indicated that select-by-self-test produced outcomes most consistent with individual outcomes for the NAL-NL2 condition (Aim 2).,"['37 older adults with hearing loss used five methods to select presets', 'older adults', 'older Americans with presbycusis', 'older Americans with mild-to-moderate hearing loss (Aim 1', '267 older adults with mild-to-moderate sensorineural hearing loss were obtained from the National Health and Nutrition Examination Survey database']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033074', 'cui_str': 'Presbycusis'}, {'cui': 'C1852284', 'cui_str': 'Mild to moderate hearing loss'}, {'cui': 'C3711547', 'cui_str': 'AURKB protein, human'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0376344', 'cui_str': 'NHANES'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],[],267.0,0.0331809,Statistical analysis indicated that select-by-self-test produced outcomes most consistent with individual outcomes for the NAL-NL2 condition (Aim 2).,"[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Urbanski', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}, {'ForeName': 'Helin', 'Initials': 'H', 'LastName': 'Hernandez', 'Affiliation': 'Department of Biostatistics, The University of Iowa, Iowa City.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, The University of Iowa, Iowa City.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}]",American journal of audiology,['10.1044/2020_AJA-20-00085']
2349,33264568,Inducing positive emotions to reduce chronic pain: a randomized controlled trial of positive psychology exercises.,"PURPOSE
Positive emotions have been found to be analgesic and can be induced by positive psychology exercises. This study tested if positive psychology exercises provide beneficial effects on pain, responses to pain, physical (pain interference), and emotional function.
METHODS
Randomized parallel-group controlled single-blinded superiority-trial including community-dwelling individuals with chronic pain secondary to spinal cord injury. Participants in the intervention group were instructed to practice 4 personalized positive psychology exercises for 8 weeks. Participants in the control group were asked to be mindful and write about current life events.
RESULTS
108 (64%) completed the study. At post-treatment, the intervention participants reported significant reductions in pain intensity and improvements in pain catastrophizing and pain control, relative to baseline. Both groups reported significant decreases in pain interference and negative emotions. Significant between-group differences emerged for pain intensity at post-treatment. At 3-months follow-up, improvements maintained for the intervention group and improvements in positive emotions reached statistical significance. Between-group differences were identified for pain intensity at post-treatment.
CONCLUSION
Positive psychology exercises represent a potential effective complementary treatment that result in benefits on pain which can be readily implemented into daily living. Trials designed with an inactive control condition should be conducted to further address efficacy.
TRIAL REGISTRATION
Swiss ethics committee (EKNZ 2014-317)/clinicaltrials.gov (NCT02459028) Registration date: Ethics approval 25.10.2014/Study start date: May 2015 URL of the record: https://clinicaltrials.gov/ct2/show/NCT02459028?term=NCT02459028&cntry=CH&draw=2&rank=1 IMPLICATIONS FOR REHABILITATION Pain engenders negative emotions (e.g., fear, anger, sadness) which can negatively affect psychological, social, and physical function. Positive emotions have been found to be analgesic and can be induced by practicing positive psychology exercises. The findings of the current randomized controlled trial provide support for practicing positive psychology exercises (beyond the effects of pain medication intake), in particular on the reduction of pain intensity, but also in improving pain catastrophizing and pain control. The majority of the positive psychology exercises are brief and self-administered positive activities that have no known negative side effects nor financial cost, can be tailored to a person's preferences in activities and can be readily implemented into daily living with chronic pain, complementing standard treatment of pain.",2020,"At post-treatment, the intervention participants reported significant reductions in pain intensity and improvements in pain catastrophizing and pain control, relative to baseline.","['108 (64%) completed the study', 'community-dwelling individuals with chronic pain secondary to spinal cord injury']","['Positive psychology exercises', 'practice 4 personalized positive psychology exercises', 'practicing positive psychology exercises', 'positive psychology exercises']","['pain intensity and improvements in pain catastrophizing and pain control', 'pain intensity', 'pain, responses to pain, physical (pain interference), and emotional function', 'positive emotions', 'pain interference and negative emotions', 'chronic pain', 'pain catastrophizing and pain control']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.181423,"At post-treatment, the intervention participants reported significant reductions in pain intensity and improvements in pain catastrophizing and pain control, relative to baseline.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Müller', 'Affiliation': 'Swiss Paraplegic Research (SPF), Nottwil, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Segerer', 'Affiliation': 'Swiss Paraplegic Research (SPF), Nottwil, Switzerland.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Ronca', 'Affiliation': 'Swiss Paraplegic Research (SPF), Nottwil, Switzerland.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Gemperli', 'Affiliation': 'Swiss Paraplegic Research (SPF), Nottwil, Switzerland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stirnimann', 'Affiliation': 'Paraplegic Center, Balgrist University Hospital, Zurich, Switzerland.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Scheel-Sailer', 'Affiliation': 'Swiss Paraplegic Centre, Guido A, Nottwil, Switzerland.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, Harborview Medical Center, University of Washington, Seattle, WA, USA.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1850888']
2350,33239000,"Analysis of body mass index, weight loss and progression of idiopathic pulmonary fibrosis.","BACKGROUND
Nintedanib is an approved therapy for idiopathic pulmonary fibrosis (IPF). Some patients treated with nintedanib experience weight loss. Exploratory data suggest that low body mass index or weight loss are associated with worse outcomes in patients with IPF. We investigated whether BMI at baseline or weight loss over 52 weeks was associated with FVC decline, or influenced the effect of nintedanib, in patients with IPF.
METHODS
Using pooled data from the two INPULSIS trials, we analysed the rate of decline in FVC (mL/yr) over 52 weeks in patients treated with nintedanib and placebo in subgroups by baseline BMI (< 25; ≥25 to < 30; ≥30 kg/m 2 ) and by weight loss over 52 weeks (≤5; > 5%) using random coefficient regression.
RESULTS
In the placebo group, the mean rate of FVC decline over 52 weeks was numerically greater in patients with lower baseline BMI (- 283.3 [SE 22.4], - 207.9 [20.9] and - 104.5 [21.4] in patients with BMI < 25 kg/m 2 , ≥25 to < 30 kg/m 2 and ≥ 30 kg/m 2 , respectively). Nintedanib reduced the rate of FVC decline versus placebo in all subgroups by BMI, with a consistent treatment effect across subgroups (interaction p = 0.31). In the placebo group, the mean rate of FVC decline was numerically greater in patients with > 5% than ≤5% weight loss over 52 weeks (- 312.7 [SE 32.2] versus - 199.5 [SE 14.4] mL/year). Nintedanib reduced the rate of FVC decline versus placebo in both subgroups by weight loss, with a greater treatment effect in patients with > 5% weight loss (interaction p = 0.0008). The adverse event profile of nintedanib was similar across subgroups.
CONCLUSIONS
In patients with IPF, lower BMI and weight loss may be associated with faster decline in FVC. Nintedanib reduces the rate of FVC decline both in patients who lose weight on treatment and those who do not.
TRIAL REGISTRATION
ClinicalTrials.gov ; Nos. NCT01335464 and NCT01335477 ; URL: www.clinicaltrials.gov .",2020,"Nintedanib reduced the rate of FVC decline versus placebo in all subgroups by BMI, with a consistent treatment effect across subgroups (interaction p = 0.31).","['patients with IPF', 'in subgroups by baseline BMI (<\u200925; ≥25 to <\u200930; ≥30\u2009kg/m 2 ) and by weight loss over 52\u2009weeks (≤5; >\u20095%) using random coefficient regression', 'idiopathic pulmonary fibrosis (IPF', 'patients treated with nintedanib experience weight loss']","['placebo', 'nintedanib and placebo']","['rate of FVC decline', 'rate of decline in FVC', 'adverse event profile of nintedanib', 'body mass index, weight loss and progression of idiopathic pulmonary fibrosis', 'BMI and weight loss', 'mean rate of FVC decline', 'BMI at baseline or weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}]","[{'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.208494,"Nintedanib reduced the rate of FVC decline versus placebo in all subgroups by BMI, with a consistent treatment effect across subgroups (interaction p = 0.31).","[{'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Jouneau', 'Affiliation': 'Department of Respiratory Medicine, Competences Centre for Rare Pulmonary Diseases, Pontchaillou Hospital, CHU Rennes, univ Rennes, Rennes 1 University, Rennes, France. stephane.jouneau@chu-rennes.fr.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'Université de Paris, Inserm U1152, APHP, Hôpital Bichat, Centre de reference constitutif pour les maladies pulmonaires rares, Paris, France.'}, {'ForeName': 'Ronan', 'Initials': 'R', 'LastName': 'Thibault', 'Affiliation': 'INRA, Inserm, Univ Rennes, Nutrition Metabolisms and Cancer, NuMeCan, Unité de Nutrition, CHU Rennes, Rennes, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Lederlin', 'Affiliation': 'Department of Radiology, CHU Rennes, univ Rennes, Rennes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vernhet', 'Affiliation': 'Univ Rennes, Inserm, EHESP, Irset (Institut de recherche en santé, environnement et travail) - UMR_S 1085, F-35000, Rennes, France.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Valenzuela', 'Affiliation': 'Pulmonology Department, Hospital Universitario de La Princesa, Madrid, Spain.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus MC, University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology and Respiratory Care Medicine, Thoraxklinik, University of Heidelberg, Member of the German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'Wibke', 'Initials': 'W', 'LastName': 'Stansen', 'Affiliation': 'Boehringer Ingelheim GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Quaresma', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Reference Center for Rare Pulmonary Diseases, Louis Pradel Hospital, Claude Bernard University Lyon 1, Lyon, France.'}]",Respiratory research,['10.1186/s12931-020-01528-4']
2351,33048904,The Effects of Melatonin Supplementation on Sleep Quality and Assessment of the Serum Melatonin in ICU Patients: A Randomized Controlled Trial.,"OBJECTIVES
To evaluate whether the use of exogenous melatonin affects sleep, reduces the prevalence of delirium, and decreases the need for analgosedation and to assess whether serum melatonin indices correlate with exogenous administration in critically ill patients.
DESIGN
Double-blind, randomized, placebo-controlled study.
SETTING
Multicenter ICUs of two tertiary hospitals.
PATIENTS
A total of 203 adult patients who were admitted to the ICU and administered with analgesics and/or sedatives.
INTERVENTIONS
Oral melatonin (10 mg) or placebo for up to seven consecutive nights.
MEASUREMENTS AND MAIN RESULTS
The number of observed sleeping hours at night was assessed by the bedside nurse. Sleep quality was evaluated using the Richards Campbell Questionnaire Sleep (RCSQ). The prevalence of delirium, pain, anxiety, adverse reactions, duration of mechanical ventilation, length of ICU and hospital stays, and doses of sedative and analgesic drugs administered were recorded. The use of analgesics and sedatives was assessed daily. Melatonin levels were determined by enzyme-linked immunosorbent assay. Based on the RCSQ results, sleep quality was assessed to be better in the melatonin group than that in the placebo group with a mean (SD) of 69.7 (21.2) and 60.7 (26.3), respectively (p = 0.029). About 45.8% and 34.4% of participants in the melatonin and placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively. No significant difference was observed regarding the days free of analgesics or sedatives, the duration of night sleep, and the occurrence of delirium, pain, and anxiety. Melatonin serum peak levels at 2 AM were 150 pg/mL (range, 125-2,125 pg/mL) in the melatonin group and 32.5 pg/mL (range, 18.5-35 pg/mL) in the placebo group (p < 0.001).
CONCLUSIONS
Melatonin was associated with better sleep quality, which suggests its possible role in the routine care of critically ill patients in the future.",2020,"placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively.","['203 adult patients who were admitted to the ICU and administered with analgesics and/or sedatives', 'Multicenter ICUs of two tertiary hospitals', 'ICU Patients', 'critically ill patients']","['melatonin', 'Melatonin Supplementation', 'exogenous melatonin', 'placebo', 'Oral melatonin', 'Melatonin']","['Campbell Questionnaire Sleep (RCSQ', 'good sleep', 'days free of analgesics or sedatives, the duration of night sleep, and the occurrence of delirium, pain, and anxiety', 'Melatonin serum peak levels', 'Melatonin levels', 'prevalence of delirium, pain, anxiety, adverse reactions, duration of mechanical ventilation, length of ICU and hospital stays, and doses of sedative and analgesic drugs', 'Sleep quality', 'Sleep Quality and Assessment of the Serum Melatonin', 'sleep quality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",203.0,0.558056,"placebo groups had very good sleep (risk ratio, 1.33; 95% CI, 0.94-1.89), whereas 3.1% and 14.6% had very poor sleep (risk ratio, 0.21; 95% CI, 0.06-0.71), respectively.","[{'ForeName': 'Joelma Villafanha', 'Initials': 'JV', 'LastName': 'Gandolfi', 'Affiliation': '1Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil. 2Cardiologic Intensive Care Unit, Hospital de Base and São José do Rio Preto Medical School, São José do Rio Preto, Brazil. 3Pio XII Foundation, Hospital do Câncer de Barretos, Barretos, Brazil.'}, {'ForeName': 'Ana Paula Altimari', 'Initials': 'APA', 'LastName': 'Di Bernardo', 'Affiliation': ''}, {'ForeName': 'Débora Augusto Valverde', 'Initials': 'DAV', 'LastName': 'Chanes', 'Affiliation': ''}, {'ForeName': 'Danilo Fernando', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Vanessa Bonafim', 'Initials': 'VB', 'LastName': 'Joles', 'Affiliation': ''}, {'ForeName': 'Cristina Prata', 'Initials': 'CP', 'LastName': 'Amendola', 'Affiliation': ''}, {'ForeName': 'Luciana Coelho', 'Initials': 'LC', 'LastName': 'Sanches', 'Affiliation': ''}, {'ForeName': 'Gustavo Larsen', 'Initials': 'GL', 'LastName': 'Ciorlia', 'Affiliation': ''}, {'ForeName': 'Suzana Margareth', 'Initials': 'SM', 'LastName': 'Lobo', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004690']
2352,33048906,Effect of Nurse-Led Consultations on Post-Traumatic Stress and Sense of Coherence in Discharged ICU Patients With Clinically Relevant Post-Traumatic Stress Symptoms-A Randomized Controlled Trial.,"OBJECTIVES
To investigate the effect of nurse-led consultations on reducing post-traumatic stress symptoms and increasing sense of coherence in discharged ICU patients with clinically relevant post-traumatic stress symptoms and to identify variables associated with symptoms 12 months later.
DESIGN
A pragmatic nonblinded randomized controlled trial.
SETTINGS
Five surgical and medical ICUs at Oslo University Hospital.
PATIENTS
Adult patients treated in the ICU greater than or equal to 24 hours were screened with Post-Traumatic Stress Scale 10 intensive part B after ICU discharge. Those scoring greater than or equal to 25 were included in the study.
INTERVENTION
Patients randomized to intervention group were offered three nurse-led consultations within 2 months, and patients in the control group received standard care.
MEASUREMENTS AND MAIN RESULTS
Sense of Coherence Scale 13 and Post-Traumatic Stress Scale 10 intensive part B were completed after inclusion, and reevaluated after 3, 6, and 12 months. Linear mixed model for repeated measures and linear regression analyses were performed. Among 523 screened patients, 111 and 113 were randomized to intervention group and control group, respectively. Mean Post-Traumatic Stress Scale 10 intensive part B score was 37 (±10) before randomization. No differences in post-traumatic stress symptoms or sense of coherence were found between intervention group versus control group, with a mean Post-Traumatic Stress Scale 10 intensive part B score 39 (95% CI, 37-41) versus 37 (95% CI, 35-39), 32 (95% CI, 28-35) versus 32 (95% CI, 29-35), 31 (95% CI, 28-34) versus 30 (95% CI, 27-33), and 31 (95% CI, 28-34) versus 29 (95% CI, 26-33) at baseline, 3, 6, and 12 months, respectively. There was a significantly reduced Post-Traumatic Stress Scale 10 intensive part B score for both groups during the year (p = 0.001). Low sense of coherence, pain, and previous psychiatric problems were associated with increased level of post-traumatic stress symptoms at 12 months.
CONCLUSIONS
Nurse-led consultations did not reveal any significant effect on post-traumatic stress symptoms or sense of coherence after ICU discharge in patients with clinically relevant symptoms.",2020,"CONCLUSIONS
Nurse-led consultations did not reveal any significant effect on post-traumatic stress symptoms or sense of coherence after ICU discharge in patients with clinically relevant symptoms.","['discharged ICU patients with clinically relevant post-traumatic stress symptoms', 'Five surgical and medical ICUs at Oslo University Hospital', '523 screened patients, 111 and 113', 'Discharged ICU Patients With Clinically Relevant Post-Traumatic Stress Symptoms', 'Adult patients treated in the ICU greater than or equal to 24 hours were screened with Post-Traumatic Stress Scale 10 intensive part B after ICU discharge', 'patients with clinically relevant symptoms']","['control group received standard care', 'nurse-led consultations', 'Nurse-Led Consultations']","['level of post-traumatic stress symptoms', 'mean Post-Traumatic Stress Scale 10 intensive part B score', 'Mean Post-Traumatic Stress Scale 10 intensive part B score', 'Sense of Coherence Scale 13 and Post-Traumatic Stress Scale 10 intensive part B', 'Post-Traumatic Stress Scale 10 intensive part B score', 'post-traumatic stress symptoms or sense of coherence', 'Low sense of coherence, pain, and previous psychiatric problems', 'Post-Traumatic Stress and Sense of Coherence']","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439091', 'cui_str': '>='}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3178983', 'cui_str': 'Salutogenesis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",523.0,0.121023,"CONCLUSIONS
Nurse-led consultations did not reveal any significant effect on post-traumatic stress symptoms or sense of coherence after ICU discharge in patients with clinically relevant symptoms.","[{'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Valsø', 'Affiliation': '1Division of Emergencies and Critical Care, Department of Postoperative and Intensive Care, Oslo University Hospital, Oslo, Norway. 2Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway. 3Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway. 4Department of Public Health, Oslo Metropolitan University, Oslo, Norway. 5Division of Mental Health and Addiction, Oslo University Hospital, Oslo, Norway. 6Department of Research, Sunnaas Rehabilitation Hospital, Bjørnemyr, Norway. 7Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway. 8Unit for Breast and Endocrine surgery, Division of Cancer Medicine, Oslo University Hospital, Oslo, Norway. 9Oslo University Hospital, Oslo, Norway. 10Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway. 11Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Tone', 'Initials': 'T', 'LastName': 'Rustøen', 'Affiliation': ''}, {'ForeName': 'Milada Cvancarova', 'Initials': 'MC', 'LastName': 'Småstuen', 'Affiliation': ''}, {'ForeName': 'Øivind', 'Initials': 'Ø', 'LastName': 'Ekeberg', 'Affiliation': ''}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Skogstad', 'Affiliation': ''}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Schou-Bredal', 'Affiliation': ''}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Myhren', 'Affiliation': ''}, {'ForeName': 'Kjetil', 'Initials': 'K', 'LastName': 'Sunde', 'Affiliation': ''}, {'ForeName': 'Kirsti', 'Initials': 'K', 'LastName': 'Tøien', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004628']
2353,33050671,"Relationship between Perceived Training Load, Well-Being Indices, Recovery State and Physical Enjoyment during Judo-Specific Training.","This study investigated the relationship between well-being indices and the session rating of perceived exertion (session-RPE), recovery (TQR), and physical enjoyment (PE) during intensified, tapering phases of judo training. Sixty-one judo athletes (37 males, ranges 14-17 years, 159-172 cm, 51-67 kg) were randomly assigned to three experimental (i.e., randori, uchi-komi, running) and control groups (regular training). Experimental groups trained four times per week for 4 weeks of intensified training followed by 12 days of tapering. Session-RPE, well-being indices (i.e., sleep, stress, fatigue, delayed onset of muscle soreness (DOMS), Hooper index (HI)), and TQR were measured every session, whereas PE was recorded after intensified, tapering periods. Recovery (TQR) was negatively correlated with sleep, stress, fatigue, DOMS, HI, session-RPE in intensified period and was negatively correlated with sleep, stress, fatigue, DOMS, HI in tapering. Session-RPE was positively correlated with sleep, fatigue, DOMS, HI in intensified period and positively correlated with fatigue, DOMS in tapering. PE was negatively correlated with stress in intensified training. Enjoyment could be partially predicted by sleep only in intensified periods. Session-RPE could be partially predicted by TQR, fatigue during intensified periods and by sleep, and HI during tapering. Sleep, recovery state, pre-fatigue states, and HI are signals contributing to the enjoyment and internal intensity variability during training. Coaches can use these simple tools to monitor judo training.",2020,"Recovery (TQR) was negatively correlated with sleep, stress, fatigue, DOMS, HI, session-RPE in intensified period and was negatively correlated with sleep, stress, fatigue, DOMS, HI in tapering.","['Sixty-one judo athletes (37 males, ranges 14-17 years, 159-172 cm, 51-67 kg']",[],"['sleep, fatigue, DOMS, HI', 'Session-RPE, well-being indices (i.e., sleep, stress, fatigue, delayed onset of muscle soreness (DOMS), Hooper index (HI)), and TQR', 'sleep, stress, fatigue, DOMS, HI, session-RPE', 'Sleep, recovery state, pre-fatigue states, and HI are signals contributing to the enjoyment and internal intensity variability', 'Well-Being Indices, Recovery State and Physical Enjoyment', 'sleep, stress, fatigue, DOMS, HI in tapering', 'PE', 'Recovery (TQR', 'session rating of perceived exertion (session-RPE), recovery (TQR), and physical enjoyment (PE']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517601', 'cui_str': '172'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",61.0,0.020412,"Recovery (TQR) was negatively correlated with sleep, stress, fatigue, DOMS, HI, session-RPE in intensified period and was negatively correlated with sleep, stress, fatigue, DOMS, HI in tapering.","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Ouergui', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'Martial Arts and Combat Sports Research Group, School of Physical Education and Sport, University of São Paulo, 05508-030 São Paulo, Brazil.'}, {'ForeName': 'Okba', 'Initials': 'O', 'LastName': 'Selmi', 'Affiliation': 'High Institute of Sports and Physical Education of Kef, University of Jendouba, Boulifa University Campus, Kef 7100, Tunisia.'}, {'ForeName': 'Danielle Evé', 'Initials': 'DE', 'LastName': 'Levitt', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Chtourou', 'Affiliation': 'High Institute of Sport and Physical Education of Sfax, Université de Sfax, Sfax 3000, Tunisie.'}, {'ForeName': 'Ezdine', 'Initials': 'E', 'LastName': 'Bouhlel', 'Affiliation': 'Laboratory of Cardio-Circulatory, Respiratory, Metabolic and Hormonal Adaptations to Muscular Exercise, Faculty of Medicine Ibn El Jazzar, University of Sousse, Sousse 4000, Tunisia.'}, {'ForeName': 'Luca Paolo', 'Initials': 'LP', 'LastName': 'Ardigò', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, School of Exercise and Sport Science, University of Verona, 37131 Verona, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17207400']
2354,33064299,Inosine 5'-Monophosphate to Raise Serum Uric Acid Level in Multiple System Atrophy (IMPROVE-MSA study).,"The aim of this trial was to investigate the safety, tolerability, and capability of serum uric acid (UA) elevation of inosine 5'-monophosphate (IMP) in multiple system atrophy (MSA). The IMPROVE-MSA trial was a randomized, double-blind, placebo-controlled trial in patients with MSA with no history of hyperuricemia-related disorders. The participants were assigned to placebo (n = 25) or IMP (n = 30) in a 1 to 1 ratio, and then followed up for 24 weeks. The primary end points included safety, tolerability, and alteration of the serum UA level during the follow-up period. The secondary end points were changes in scores of the unified MSA rating scale (UMSARS) and the Mini-Mental Status Examination (MMSE) and Montreal Cognitive Assessment (MoCA). The total number of adverse events (AEs) and serious AEs was comparable between the active and placebo groups. Serum UA level (mg/dL) was significantly increased from baseline (active vs. placebo, 4.57 vs. 4.58; P = 0.98) to study end point (6.96 vs. 4.43; P < 0.001) in the active group compared with the placebo group (time × group interaction; P < 0.001). The change in UMSARS scores did not differ between the active and placebo groups. However, the active group showed better alterations in MoCA scores with nominal significance (P < 0.001) and tendency for better alterations in MMSE scores (P = 0.09) than the placebo group. Our data demonstrated that IMP treatment was generally safe and well-tolerated in patients with MSA. A further trial with a long-term follow-up is required to examine whether UA elevation will slow clinical progression in early MSA.",2020,"However, the active group showed significantly better alterations in MoCA scores with nominal significance (p <0.001) and tendency for better alterations in MMSE scores (p = 0.09) than the placebo group.","['MSA patients with no history of hyperuricemia-related disorders', 'patients with MSA']","[""Inosine 5'-Monophosphate"", 'placebo', 'IMP']","['total number of adverse events (AE) and serious AE', 'Serum UA level', 'UMSARS scores', 'MoCA scores', ""safety, tolerability, and capability of serum uric acid (UA) elevation of inosine 5'-monophosphate (IMP"", 'safe and well tolerated', 'changes in scores of the unified MSA rating scale (UMSARS) and the Mini-Mental Status Examination (MMSE) and Montreal Cognitive Assessment (MoCA', 'safety, tolerability, and alteration of the serum UA level', 'MMSE scores']","[{'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0000294', 'cui_str': 'Mesna'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0021528', 'cui_str': 'Inosine'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0393571', 'cui_str': 'Multiple system atrophy'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}]",,0.442729,"However, the active group showed significantly better alterations in MoCA scores with nominal significance (p <0.001) and tendency for better alterations in MMSE scores (p = 0.09) than the placebo group.","[{'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Jung Lee', 'Affiliation': 'Department of Neurology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Jung', 'Initials': 'J', 'LastName': 'Han Yoon', 'Affiliation': 'Department of Neurology, Ajou University School of Medicine, Suwon, South Korea.'}, {'ForeName': 'Sang', 'Initials': 'S', 'LastName': 'Jin Kim', 'Affiliation': 'Department of Neurology, Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Soo Yoo', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok', 'Initials': 'S', 'LastName': 'Jong Chung', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hyun Lee', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Suk', 'Initials': 'S', 'LastName': 'Yun Kang', 'Affiliation': 'Department of Neurology, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, South Korea.'}, {'ForeName': 'Hae-Won', 'Initials': 'HW', 'LastName': 'Shin', 'Affiliation': 'Department of Neurology, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sook', 'Initials': 'S', 'LastName': 'Keun Song', 'Affiliation': 'Department of Neurology, Jeju National University School of Medicine, Jeju, South Korea.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yong Hong', 'Affiliation': 'Department of Neurology, Yonsei University Wonju College of Medicine, Wonju, South Korea.'}, {'ForeName': 'MunKyung', 'Initials': 'M', 'LastName': 'Sunwoo', 'Affiliation': 'Department of Neurology, Bundang Jesaeng General Hospital, Seongnam, South Korea.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Eun Lee', 'Affiliation': 'Department of Neurology, National Health Insurance Service Ilsan Hospital, Goyang, South Korea.'}, {'ForeName': 'Jong', 'Initials': 'J', 'LastName': 'Sam Baik', 'Affiliation': 'Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young H', 'Initials': 'YH', 'LastName': 'Sohn', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Hyu Lee', 'Affiliation': 'Department of Neurology, Yonsei University College of Medicine, Seoul, South Korea.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.2082']
2355,33060555,"Comparison of Regularly Scheduled Ibuprofen Versus ""Pro Re Nata"" for Ankle Sprains in Children Treated in the Emergency Department: A Randomized Controlled Trial.","OBJECTIVE
We compared pain and degree of disability in patients with acute ankle sprains receiving regular scheduled ibuprofen versus pro re nata (PRN).
METHODS
This study is a randomized single-blinded controlled trial of children aged 7 to 17 years presenting with acute ankle sprain to an emergency department. Patients were randomized to receive 10 mg/kg of ibuprofen per dose (maximum 600 mg) every 6 hours regular scheduled versus PRN. Outcome measures included a 100-mm visual analog scale pain and degree of disability at day 4. A sample size of 72 children had a power of 80% to detect a clinically meaningful difference of 20 mm between the regular and PRN group.
RESULTS
We randomly assigned 99 patients to receive regular scheduled (n = 50) or PRN (n = 49) ibuprofen. Pain scores and degree of disability at day 4 showed no significant differences between groups. The rate of reported adverse effects was higher in the regular scheduled group (11.4% vs 9.5%) versus the PRN group.
CONCLUSIONS
Our study suggests that there is little benefit from routinely using a regular scheduled ibuprofen regimen for acute pediatric ankle sprains.",2020,Pain scores and degree of disability at day 4 showed no significant differences between groups.,"['children aged 7 to 17 years presenting with acute ankle sprain to an emergency department', 'Ankle Sprains in Children Treated in the Emergency Department', 'patients with acute ankle sprains receiving regular scheduled', 'acute pediatric ankle sprains', '99 patients to receive regular scheduled (n = 50) or']","['ibuprofen per dose (maximum 600 mg) every 6 hours regular scheduled versus PRN', 'ibuprofen versus pro re nata (PRN', 'Ibuprofen Versus ""Pro Re Nata', 'ibuprofen', 'PRN']","['100-mm visual analog scale pain and degree of disability at day 4', 'rate of reported adverse effects', 'pain and degree of disability', 'Pain scores and degree of disability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0585325', 'cui_str': 'Every six hours'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",99.0,0.259092,Pain scores and degree of disability at day 4 showed no significant differences between groups.,"[{'ForeName': 'Rodrick', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Gurinder', 'Initials': 'G', 'LastName': 'Sangha', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lepore', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Katelyn M', 'Initials': 'KM', 'LastName': 'Bartlett', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Jamie A', 'Initials': 'JA', 'LastName': 'Seabrook', 'Affiliation': 'From the Department of Paediatrics, Western University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rieder', 'Affiliation': 'From the Department of Paediatrics, Western University.'}]",Pediatric emergency care,['10.1097/PEC.0000000000002282']
2356,33057953,A Pharmacokinetic Bridging Study to Compare Systemic Exposure to Budesonide between Budesonide Oral Suspension and ENTOCORT EC in Healthy Individuals.,"BACKGROUND AND OBJECTIVES
Currently, there are no US FDA-approved therapies for eosinophilic esophagitis (EoE). Budesonide oral suspension (BOS; SHP621, TAK-721) is a viscous, muco-adherent, oral formulation of budesonide that is in phase III development for the treatment of EoE. BOS 2 mg twice daily was studied in 12- and 36-week phase III studies for the induction and maintenance of clinical remission in adults and adolescents with EoE (NCT02605837 and NCT02736409). ENTOCORT EC is a gelatin capsule formulation of budesonide that is FDA-approved for the treatment of mild-to-moderate active Crohn's disease (CD) in adults and children. This study compared the systemic exposure to budesonide from BOS with that from ENTOCORT EC, aiming to provide the pharmacokinetic (PK) bridge to the safety data of ENTOCORT EC.
METHODS
Healthy adult volunteers (n = 22) were enrolled in an open-label, single-center, crossover study. Participants received a single oral dose of BOS 2 mg and a single oral dose of ENTOCORT EC 9 mg under fasting conditions in a randomized sequence, with a 48-h washout period between treatments. PK parameters were calculated by non-compartmental analysis and compared between treatments using a mixed-effects model with sequence and treatment as fixed effects and individuals within sequence as a random effect.
RESULTS
Plasma budesonide concentrations showed that budesonide was absorbed significantly faster from BOS 2 mg than from ENTOCORT EC 9 mg, with peak concentrations reached at 1.5 and 4 h, respectively (p < 0.001). Systemic exposure to budesonide after a single oral dose of BOS 2 mg was lower than that observed after a single oral dose of ENTOCORT EC 9 mg; the least squares geometric mean maximum plasma concentration and the area under the concentration-time curve from the time of dosing to infinity and from the time of dosing to the last measurable concentration of budesonide after BOS 2 mg were 71.1%, 33.5%, and 33.6% of those after ENTOCORT EC 9 mg, respectively. No notable differences in treatment-emergent adverse events were observed between individuals treated with either drug; all events were mild and none resulted in discontinuation from the study.
CONCLUSIONS
This study demonstrated that systemic exposure to budesonide after a single oral dose of BOS 2 mg was lower than that after a single oral dose of ENTOCORT EC 9 mg. These results provide PK bridging data to compare BOS with therapeutic doses of ENTOCORT EC with respect to safety information.",2020,"No notable differences in treatment-emergent adverse events were observed between individuals treated with either drug; all events were mild and none resulted in discontinuation from the study.
","[""mild-to-moderate active Crohn's disease (CD) in adults and children"", 'Healthy adult volunteers (n\u2009=\u200922', 'Healthy Individuals']","['Budesonide', 'budesonide', 'Budesonide Oral Suspension and ENTOCORT EC', 'Budesonide oral suspension (BOS; SHP621, TAK-721']","['Plasma budesonide concentrations', 'PK parameters', 'treatment-emergent adverse events']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0592459', 'cui_str': 'Budesonide-containing product in oral dose form'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0593928', 'cui_str': 'Entocort'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",22.0,0.0485298,"No notable differences in treatment-emergent adverse events were observed between individuals treated with either drug; all events were mild and none resulted in discontinuation from the study.
","[{'ForeName': 'Ivy H', 'Initials': 'IH', 'LastName': 'Song', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Member of the Takeda Group of Companies, 300 Shire Way, Lexington, MA, 02421, USA. ivy.song@takeda.com.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Finkelman', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Member of the Takeda Group of Companies, 300 Shire Way, Lexington, MA, 02421, USA.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Shire Human Genetic Therapies, Inc., a Member of the Takeda Group of Companies, 300 Shire Way, Lexington, MA, 02421, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00324-1']
2357,33262580,A Community and Technology-Based Approach for Hypertension Self-Management (COACHMAN) to Improve Blood Pressure Control in African Americans: Results from a Pilot Study.,"Purpose
Adoption of technology has increased to support self-managing chronic diseases. However, behavioral interventions evaluating such technology have been understudied in African Americans with hypertension. The aim of this study was to explore a community and technology-based intervention for hypertension self-management (COACHMAN) intervention on blood pressure (BP) control and health-related quality of life (HRQoL) in African Americans with hypertension.
Methods
Sixty African Americans (mean age 60; 75% females) who were prescribed antihypertensive medications and owning a smartphone were randomized to the COACHMAN (n = 30) or enhanced usual care (n = 30) group for 12 weeks. COACHMAN is comprised of four components: web-based education, home BP monitoring, medication management application, and nurse counseling. Hypertension knowledge, self-efficacy, technology adoption/use, medication adherence, BP, and HRQoL scores were assessed.
Results
Mean systolic and diastolic BP at baseline was 150.49 (SD = 13.89) and 86.80 (SD = 13.39), respectively. After completing the 3-month intervention to improve hypertension self-management, the groups did not significantly differ in BP control and HRQoL. Clinically relevant BP reduction was observed in the intervention group. Paired t -test showed that mean medication-taking adherence scores significantly improved in the intervention group ( P = 0.023) compared to the control group ( P = 0.075).
Conclusion
Using technology may have a positive impact on supporting hypertension self-management, particularly in medication-taking adherence. Further research is warranted in a larger sample and should include standardization of medication management to isolate the effects of behavioral interventions on changes in BP.
Clinicaltrialsgov Identifier
NCT03722667.",2020,"After completing the 3-month intervention to improve hypertension self-management, the groups did not significantly differ in BP control and HRQoL. Clinically relevant BP reduction was observed in the intervention group.","['African Americans', 'Sixty African Americans (mean age 60; 75% females) who were prescribed antihypertensive medications and owning a smartphone', 'African Americans with hypertension']","['community and technology-based intervention for hypertension self-management (COACHMAN) intervention', 'enhanced usual care']","['mean medication-taking adherence scores', 'BP control and HRQoL. Clinically relevant BP reduction', 'Hypertension knowledge, self-efficacy, technology adoption/use, medication adherence, BP, and HRQoL scores', 'blood pressure (BP) control and health-related quality of life (HRQoL', 'hypertension self-management', 'Mean systolic and diastolic BP']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",60.0,0.0234543,"After completing the 3-month intervention to improve hypertension self-management, the groups did not significantly differ in BP control and HRQoL. Clinically relevant BP reduction was observed in the intervention group.","[{'ForeName': 'Carolyn H', 'Initials': 'CH', 'LastName': 'Still', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Seunghee', 'Initials': 'S', 'LastName': 'Margevicius', 'Affiliation': 'Department of Population and Quantitative Health Sciences, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Harwell', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Ming-Chun', 'Initials': 'MC', 'LastName': 'Huang', 'Affiliation': 'Department of Electrical Engineering and Computer Science, Case School of Engineering, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'LaTonya', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Community Partners, Cleveland Council of Black Nurses, Cleveland, OH, USA.'}, {'ForeName': 'Phuong B', 'Initials': 'PB', 'LastName': 'Dang', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Jackson T', 'Initials': 'JT', 'LastName': 'Wright Jnr', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Case Western Reserve University, Cleveland, OH, USA.'}]",Patient preference and adherence,['10.2147/PPA.S283086']
2358,33262578,Pharmacokinetic/Pharmacodynamic Interactions Between Evogliptin and Glimepiride in Healthy Male Subjects.,"Purpose
Evogliptin, a dipeptidyl peptidase-4 inhibitor, and glimepiride, a sulfonylurea, are used to treat type 2 diabetes mellitus. In this study, we aimed to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) interactions between evogliptin and glimepiride.
Materials and Methods
A randomized, open-label, 3-period, 3-treatment, 2-sequence crossover study was conducted in healthy male subjects. During each period, subjects received multiple doses of evogliptin 5 mg alone (EVO), glimepiride 4 mg alone (GLI), or a combination of the two (EVO+GLI). Serial blood and urine samples were collected 168 and 24 h post dosing, respectively, for PK and PD analyses.
Results
Thirty-four subjects completed the study. The co-administration of evogliptin and glimepiride did not alter their plasma and urine PK profiles. For evogliptin, the geometric mean ratio (GMR) (90% confidence intervals) for the maximum plasma concentrations at steady-state (C max,ss ) and the area under the curve during dosing interval at steady-state (AUC τ,ss ) of EVO+GLI to E were 1.02 (0.98-1.06) and 0.97 (0.95-1.00), respectively. For glimepiride, the corresponding values of EVO+GLI to GLI were 1.08 (1.01-1.17) and 1.08 (1.02-1.14), respectively. All values were within the regulatory bioequivalence criteria of 0.8-1.25. Glucose excursion decreased with the co-administration of evogliptin and glimepiride compared with that observed with the evogliptin or glimepiride monotherapy.
Conclusion
Evogliptin and glimepiride had no PK interactions when co-administered, while the combination therapy showed an additive glucose-lowering effect compared to those of evogliptin or glimepiride monotherapy.",2020,The co-administration of evogliptin and glimepiride did not alter their plasma and urine PK profiles.,"['healthy male subjects', 'Results\n\n\nThirty-four subjects completed the study', 'Healthy Male Subjects', 'type 2 diabetes mellitus']","['Evogliptin and Glimepiride', 'glimepiride, a sulfonylurea', 'evogliptin 5 mg alone (EVO), glimepiride 4 mg alone (GLI), or a combination of the two (EVO+GLI', 'glimepiride', 'evogliptin and glimepiride']","['geometric mean ratio (GMR', 'Serial blood and urine samples', 'pharmacokinetic (PK) and pharmacodynamic (PD) interactions', 'Glucose excursion', 'plasma and urine PK profiles', 'maximum plasma concentrations']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0986240', 'cui_str': 'glimepiride 4 MG'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1868979', 'cui_str': 'Pharmacodynamic interaction'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0209776,The co-administration of evogliptin and glimepiride did not alter their plasma and urine PK profiles.,"[{'ForeName': 'Hyounggyoon', 'Initials': 'H', 'LastName': 'Yoo', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'In-Jin', 'Initials': 'IJ', 'LastName': 'Jang', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung-Sang', 'Initials': 'KS', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'SeungHwan', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S275343']
2359,33262577,Comparison of Bioavailability and Bioequivalence of Generic and Brand Name Formulations of Escitalopram Oxalate Tablets in Healthy Chinese Population Under Fasting and Fed Conditions.,"Purpose
This study compared the bioequivalence of two formulations of escitalopram oxalate 20 mg tablets in terms of bioavailability and tolerability in healthy Chinese male and female subjects.
Patients and Methods
A randomized, single-blind, two-period, two-sequence crossover study was performed under fasting and fed conditions, with a 21-day washout period. In total, 24 healthy subjects (18 males and 6 females) were enrolled in the fasting test and the fed test, respectively. Blood samples were collected over 168 h post-dose in each period. The concentrations of escitalopram in plasma were determined by high-performance liquid chromatography coupled with a tandem mass spectrometry. Pharmacokinetic parameters used for bioequivalence assessment were determined from the drug concentration data using noncompartmental analysis.
Results
All subjects showed good medication compliance. The 90% confidence intervals (CIs) for the geometric mean ratios of AUC 0-t , AUC 0-∞ , and C max were within the bioequivalence acceptance criteria (80.00% to 125.00%). Adverse events were recorded and no deaths or serious adverse events (SAEs) occurred.
Conclusion
Escitalopram oxalate 20 mg tablets produced in China were bioequivalent to the reference formulation (Lexapro ® ) in healthy Chinese male and female subjects under fasting and fed conditions.",2020,"Adverse events were recorded and no deaths or serious adverse events (SAEs) occurred.
","['healthy Chinese male and female subjects under fasting and fed conditions', '24 healthy subjects (18 males and 6 females', 'healthy Chinese male and female subjects', 'Healthy Chinese Population Under Fasting and Fed Conditions']","['Escitalopram Oxalate Tablets', 'escitalopram oxalate 20 mg tablets', 'reference formulation (Lexapro ® ']","['good medication compliance', 'bioavailability and tolerability', 'concentrations of escitalopram in plasma', 'Adverse events', 'deaths or serious adverse events (SAEs', 'Blood samples']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0342895', 'cui_str': 'Fish-eye disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C1170371', 'cui_str': 'Lexapro'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",24.0,0.0327533,"Adverse events were recorded and no deaths or serious adverse events (SAEs) occurred.
","[{'ForeName': 'Qiuying', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Drug Clinical Trial Management Agency, General Hospital of Northern Theater Command, Shenyang 110840, People's Republic of China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huo', 'Affiliation': ""Department of Drug Clinical Trial Management Agency, General Hospital of Northern Theater Command, Shenyang 110840, People's Republic of China.""}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': ""Department of Drug Clinical Trial Management Agency, General Hospital of Northern Theater Command, Shenyang 110840, People's Republic of China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Sui', 'Affiliation': ""Department of Drug Clinical Trial Management Agency, General Hospital of Northern Theater Command, Shenyang 110840, People's Republic of China.""}, {'ForeName': 'Yunbiao', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': ""Department of Drug Clinical Trial Management Agency, General Hospital of Northern Theater Command, Shenyang 110840, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S271970']
2360,33262576,Activation of PI3K/Akt/HIF-1α Signaling is Involved in Lung Protection of Dexmedetomidine in Patients Undergoing Video-Assisted Thoracoscopic Surgery: A Pilot Study.,"Background
Lung resection and one lung ventilation (OLV) during video-assisted thoracoscopic surgery (VATS) may lead to acute lung injury. Dexmedetomidine (DEX), a highly selective α 2 adrenergic receptor agonist, improves arterial oxygenation in adult patients undergoing thoracic surgery. The aim of this pilot study was to explore possible mechanism related to lung protection of DEX in patients undergoing VATS.
Patients and Methods
Seventy-four patients scheduled for VATS were enrolled in this study. Three timepoints (before anesthesia induction (T 0 ), 40 min after OLV (T 1 ), and 10 min after two-lung ventilation (T 2 )) of arterial blood gas were obtained. Meanwhile, lung histopathologic examination, immunohistochemistry analysis (occludin and ZO-1), levels of tumor necrosis factor (TNF)-α and interleukin (IL)-6 in lung tissue and plasma, and activation of phosphoinositide-3-kinase (PI3K)/AKT/hypoxia-inducible factor (HIF)-1α signaling were detected. Postoperative outcomes including duration of withdrawing the pleural drainage tube, length of hospital stay, hospitalization expenses, and postoperative pulmonary complications (PPCs) were also recorded.
Results
Sixty-seven patients were randomly divided into DEX group (group D, n=33) and control group (group N, n=34). DEX improved oxygenation at T 1 and T 2 (group D vs group N; T 1 : 191.8 ± 49.8 mmHg vs 159.6 ± 48.1 mmHg, P = 0.009; T 2 : 406.0 mmHg [392.2-423.7] vs 374.5 mmHg [340.2-378.2], P = 0.001). DEX alleviated the alveolar capillary epithelial structure damage, increased protein expression of ZO-1 and occludin, inhibited elevation of the expression of TNF-α and IL-6 in lung tissue and plasma, and increased protein expression of p-PI3K, p-AKT and HIF-1α. Dex administered had better postoperative outcomes with less risk of PPCs and hospitalization expenses as well as shorter duration of withdrawing the pleural drainage tube and length of hospital stay.
Conclusion
Activation of PI3K/Akt/HIF-1α signaling might be involved in lung protection of DEX in patients undergoing VATS.",2020,"DEX alleviated the alveolar capillary epithelial structure damage, increased protein expression of ZO-1 and occludin, inhibited elevation of the expression of TNF-α and IL-6 in lung tissue and plasma, and increased protein expression of p-PI3K, p-AKT and HIF-1α. Dex administered had better postoperative outcomes with less risk of PPCs and hospitalization expenses as well as shorter duration of withdrawing the pleural drainage tube and length of hospital stay.
","['adult patients undergoing thoracic surgery', 'Results\n\n\nSixty-seven patients', 'Patients and Methods\n\n\nSeventy-four patients scheduled for VATS were enrolled in this study', 'Patients Undergoing Video-Assisted Thoracoscopic Surgery', 'patients undergoing VATS']","['Dexmedetomidine', 'video-assisted thoracoscopic surgery (VATS', 'Dexmedetomidine (DEX', '\n\n\nLung resection and one lung ventilation (OLV', 'DEX']","['alveolar capillary epithelial structure damage, increased protein expression of ZO-1 and occludin, inhibited elevation of the expression of TNF-α and IL-6 in lung tissue and plasma, and increased protein expression', 'oxygenation', 'arterial oxygenation', 'duration of withdrawing the pleural drainage tube, length of hospital stay, hospitalization expenses, and postoperative pulmonary complications (PPCs', 'Meanwhile, lung histopathologic examination, immunohistochemistry analysis (occludin and ZO-1), levels of tumor necrosis factor (TNF)-α and interleukin (IL)-6 in lung tissue and plasma, and activation of phosphoinositide-3-kinase']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}]","[{'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0250400', 'cui_str': 'Occludins'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}]",74.0,0.0448017,"DEX alleviated the alveolar capillary epithelial structure damage, increased protein expression of ZO-1 and occludin, inhibited elevation of the expression of TNF-α and IL-6 in lung tissue and plasma, and increased protein expression of p-PI3K, p-AKT and HIF-1α. Dex administered had better postoperative outcomes with less risk of PPCs and hospitalization expenses as well as shorter duration of withdrawing the pleural drainage tube and length of hospital stay.
","[{'ForeName': 'Linjia', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Zhenfeng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Xiahao', 'Initials': 'X', 'LastName': 'Ding', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Chanjuan', 'Initials': 'C', 'LastName': 'Gong', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Yanning', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, First Affiliated Hospital with Nanjing Medical University, Nanjing 210029, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S276005']
2361,33261645,Effects of daily 24-gram doses of rice or whey protein on resistance training adaptations in trained males.,"BACKGROUND
Large (48-g), isonitrogenous doses of rice and whey protein have previously been shown to stimulate similar adaptations to resistance training, but the impact of consuming smaller doses has yet to be compared. We evaluated the ability of 24-g doses of rice or whey protein concentrate to augment adaptations following 8 weeks of resistance training.
METHODS
Healthy resistance-trained males (n = 24, 32.8 ± 6.7 years, 179.3 ± 8.5 cm, 87.4 ± 8.5 kg, 27.2 ± 1.9 kg/m 2 , 27.8 ± 6.0% fat) were randomly assigned and matched according to fat-free mass to consume 24-g doses of rice (n = 12, Growing Naturals, LLC) or whey (n = 12, NutraBio Labs, Inc.) protein concentrate for 8 weeks while completing a standardized resistance training program. Body composition (DXA), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF] at 80% 1RM) using bench press (BP) and leg press (LP) exercises along with anaerobic capacity (Wingate) were assessed before and after the intervention. Subjects were asked to maintain regular dietary habits and record dietary intake every 2 weeks. Outcomes were assessed using 2 × 2 mixed (group x time) factorial ANOVA with repeated measures on time and independent samples t-tests using the change scores from baseline. A p-value of 0.05 and 95% confidence intervals on the changes between groups were used to determine outcomes.
RESULTS
No baseline differences (p > 0.05) were found for key body composition and performance outcomes. No changes (p > 0.05) in dietary status occurred within or between groups (34 ± 4 kcal/kg/day, 3.7 ± 0.77 g/kg/day, 1.31 ± 0.28 g/kg/day, 1.87 ± 0.23 g/kg/day) throughout the study for daily relative energy (34 ± 4 kcals/kg/day), carbohydrate (3.7 ± 0.77 g/kg/day), fat (1.31 ± 0.28 g/kg/day), and protein (1.87 ± 0.23 g/kg/day) intake. Significant main effects for time were revealed for body mass (p = 0.02), total body water (p = 0.01), lean mass (p = 0.008), fat-free mass (p = 0.007), BP 1RM (p = 0.02), BP volume (p = 0.04), and LP 1RM (p = 0.01). Changes between groups were similar for body mass (- 0.88, 2.03 kg, p = 0.42), fat-free mass (- 0.68, 1.99 kg, p = 0.32), lean mass (- 0.73, 1.91 kg, p = 0.37), fat mass (- 0.48, 1.02 kg, p = 0.46), and % fat (- 0.63, 0.71%, p = 0.90). No significant between group differences were seen for BP 1RM (- 13.8, 7.1 kg, p = 0.51), LP 1RM (- 38.8, 49.6 kg, p = 0.80), BP RTF (- 2.02, 0.35 reps, p = 0.16), LP RTF (- 1.7, 3.3 reps, p = 0.50), and Wingate peak power (- 72.5, 53.4 watts, p = 0.76) following the eight-week supplementation period.
CONCLUSIONS
Eight weeks of daily isonitrogenous 24-g doses of rice or whey protein in combination with an eight-week resistance training program led to similar changes in body composition and performance outcomes. Retroactively registered on as NCT04411173 .",2020,"LP 1RM (- 38.8, 49.6 kg, p = 0.80), BP RTF (- 2.02, 0.35 reps, p = 0.16), LP RTF (- 1.7, 3.3 reps, p = 0.50), and Wingate peak power (- 72.5, 53.4 watts,","['24, 32.8\u2009±\u20096.7\u2009years, 179.3\u2009±\u20098.5\u2009cm, 87.4\u2009±\u20098.5\u2009kg, 27.2\u2009±\u20091.9\u2009kg/m 2 , 27.8\u2009±\u20096.0% fat', 'Healthy resistance-trained males (n\xa0', 'trained males']","['rice or whey protein concentrate', 'fat-free mass to consume 24-g doses of rice (n\xa0=\u200912, Growing Naturals, LLC) or whey (n\u2009=\u200912, NutraBio Labs, Inc.) protein concentrate for 8 weeks while completing a standardized resistance training program', 'rice or whey protein']","['dietary status', 'total body water', 'fat mass', 'bench press (BP) and leg press (LP) exercises along with anaerobic capacity (Wingate', 'Body composition (DXA), muscular strength (one-repetition maximum [1RM]) and endurance (repetitions to fatigue [RTF', 'LP RTF', 'LP 1RM', 'body composition and performance outcomes', 'BP 1RM', 'BP volume', 'Wingate peak power', 'lean mass', 'BP RTF', 'resistance training adaptations', 'fat-free mass']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C5191357', 'cui_str': '27.2'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0450405', 'cui_str': '24G'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0412472', 'cui_str': 'Total body water measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}]",,0.0765973,"LP 1RM (- 38.8, 49.6 kg, p = 0.80), BP RTF (- 2.02, 0.35 reps, p = 0.16), LP RTF (- 1.7, 3.3 reps, p = 0.50), and Wingate peak power (- 72.5, 53.4 watts,","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Moon', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, 63301, USA.'}, {'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Ratliff', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, 63301, USA.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Blumkaitis', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, 63301, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Harty', 'Affiliation': 'Energy Balance and Body Composition Laboratory, Department of Kinesiology & Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Zabriskie', 'Affiliation': 'Department of Kinesiology, Towson University, Towson, MD, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Stecker', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, 63301, USA.'}, {'ForeName': 'Brad S', 'Initials': 'BS', 'LastName': 'Currier', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, 63301, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Jagim', 'Affiliation': 'Sports Medicine, Mayo Clinic Health System, Onalaska, WI, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Jäger', 'Affiliation': 'Increnovo LLC, Milwaukee, WI, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Purpura', 'Affiliation': 'Increnovo LLC, Milwaukee, WI, USA.'}, {'ForeName': 'Chad M', 'Initials': 'CM', 'LastName': 'Kerksick', 'Affiliation': 'Exercise and Performance Nutrition Laboratory, School of Health Sciences, Lindenwood University, 209 S. Kingshighway, St. Charles, MO, 63301, USA. ckerksick@lindenwood.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00394-1']
2362,33261642,The effects of alpha lipoic acid on muscle strength recovery after a single and a short-term chronic supplementation - a study in healthy well-trained individuals after intensive resistance and endurance training.,"BACKGROUND
Alpha lipoic acid (ALA) has been demonstrated to have anti-inflammatory activity and was tested as a drug for the treatment of various diseases. ALA is also frequently used as a nutrition supplement, in healthy individuals or in competitive athletes. However, information from intervention studies investigating physiological effects of an ALA in athletes after exercise is limited. Therefore, the aim of this study was to investigate the effects of single and short-term chronic ALA supplementation on the muscle strength recovery and performance of athletes after intensive exercise.
METHODS
In a double-blind, randomised, controlled trial in cross-over design, 17 male resistance and endurance-experienced athletes successfully participated. The subjects were divided into two groups (ALA and Placebo) and underwent a standardized single training session and a high intense training week. At certain time points (T0, T1a (+ 3 h), T1b (+ 24 h) and T2 (+7d)) blood samples were taken and markers for muscle damage, inflammation and oxidative stress were investigated. In addition, the maximum performance in the back squat was measured at all time points.
RESULTS
In the chronic training experiment, a moderate inhibition of muscle damage and inflammation could be observed in the ALA-group. Performance in the back squat was significantly reduced in the placebo-group, but not in the ALA-group. No anti-oxidative effects could be observed.
CONCLUSIONS
Our data indicate possible effects of ALA supplementation, during intensive training periods result in a reduction of muscle damage, inflammation and an increase of recovery. Whether ALA supplementation in general may enhance performance and the exact training / supplementation scenarios needs to be investigated in future studies.",2020,"Performance in the back squat was significantly reduced in the placebo-group, but not in the ALA-group.","['healthy well-trained individuals after intensive resistance and endurance training', 'healthy individuals or in competitive athletes', 'athletes after intensive exercise', '17 male resistance and endurance-experienced athletes successfully participated']","['ALA supplementation', 'single and short-term chronic ALA supplementation', 'ALA', 'standardized single training session and a high intense training week', 'alpha lipoic acid', 'Alpha lipoic acid (ALA', 'ALA and Placebo']","['muscle damage, inflammation and an increase of recovery', 'Performance in the back squat', 'muscle damage, inflammation and oxidative stress', 'muscle strength recovery']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0425273', 'cui_str': 'Competitive athlete'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",17.0,0.176549,"Performance in the back squat was significantly reduced in the placebo-group, but not in the ALA-group.","[{'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Isenmann', 'Affiliation': 'Institute for Cardiovascular Research and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sports University, 50933, Cologne, Germany.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Trittel', 'Affiliation': 'Institute for Cardiovascular Research and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sports University, 50933, Cologne, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Diel', 'Affiliation': 'Institute for Cardiovascular Research and Sports Medicine, Department of Molecular and Cellular Sports Medicine, German Sports University, 50933, Cologne, Germany. diel@dshs-koeln.de.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00389-y']
2363,33261635,A randomised controlled trial of heavy shoulder strengthening exercise in patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints: study protocol for the Shoulder-MOBILEX study.,"BACKGROUND
Four out of five patients with hypermobility spectrum disorder (HSD) or hypermobile Ehlers-Danlos syndrome (hEDS) experience shoulder complaints including persistent pain and instability. Evidence suggests that patients with HSD/hEDS who experience knee and back complaints improve with exercise-based therapy. However, no study has focused on exercise-based treatment for the shoulder in this patient group. The potential benefits of strengthening the shoulder muscles, such as increased muscle-tendon stiffness, may be effective for patients with HSD/hEDS who often display decreased strength and increased shoulder laxity/instability. The primary aim is to investigate the short-term effectiveness of a 16-week progressive heavy shoulder strengthening programme and general advice (HEAVY) compared with low-load training and general advice (LIGHT), on self-reported shoulder symptoms, function, and quality of life.
METHODS
A superiority, parallel group, randomised controlled trial will be conducted with 100 patients from primary care with HSD/hEDS and shoulder complaints (persistent pain and/or instability) for more than 3 months. Participants will be randomised to receive HEAVY (full range of motion, high load) or LIGHT (neutral to midrange of motion, low load) strengthening programme three times weekly with exercises targeting scapular and rotator cuff muscles. HEAVY will be supervised twice weekly, and LIGHT three times during the 16 weeks. The primary outcome will be between-group difference in change from baseline to 16-week follow-up in the Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse). Secondary outcomes will include a range of self-reported outcomes covering symptoms, function, and quality of life, besides clinical tests for shoulder strength, laxity/instability, and proprioception. Outcome assessors will be blinded to group allocation. Participants will be kept blind to treatment allocation through minimal information about the intervention content and hypotheses. Primary analyses will be performed by a blinded epidemiologist.
DISCUSSION
If effective, the current heavy shoulder strengthening programme will challenge the general understanding of prescribing low-load exercise interventions for patients with HSD/hEDS and provide a new treatment strategy. The study will address an important and severe condition using transparent, detailed, and high-quality methods to potentially support a future implementation.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03869307 . Registered on 11 March 2019.",2020,"The potential benefits of strengthening the shoulder muscles, such as increased muscle-tendon stiffness, may be effective for patients with HSD/hEDS who often display decreased strength and increased shoulder laxity/instability.","['patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints', 'five patients with hypermobility spectrum disorder (HSD) or hypermobile Ehlers-Danlos syndrome (hEDS) experience shoulder complaints including persistent pain and instability', '100 patients from primary care with HSD/hEDS and shoulder complaints (persistent pain and/or instability) for more than 3\u2009months']","['progressive heavy shoulder strengthening programme and general advice (HEAVY) compared with low-load training and general advice (LIGHT', 'heavy shoulder strengthening exercise', 'HEAVY (full range of motion, high load) or LIGHT (neutral to midrange of motion, low load) strengthening programme three times weekly with exercises targeting scapular and rotator cuff muscles']","['range of self-reported outcomes covering symptoms, function, and quality of life, besides clinical tests for shoulder strength, laxity/instability, and proprioception', 'shoulder symptoms, function, and quality of life', 'Western Ontario Shoulder Instability Index (WOSI, 0-2100 better to worse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549185', 'cui_str': 'Hypermobility'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1959673', 'cui_str': 'Muscle of rotator cuff'}]","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",5.0,0.143974,"The potential benefits of strengthening the shoulder muscles, such as increased muscle-tendon stiffness, may be effective for patients with HSD/hEDS who often display decreased strength and increased shoulder laxity/instability.","[{'ForeName': 'Behnam', 'Initials': 'B', 'LastName': 'Liaghat', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark. bliaghat@health.sdu.dk.'}, {'ForeName': 'Søren T', 'Initials': 'ST', 'LastName': 'Skou', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Søndergaard', 'Affiliation': 'Research Unit of General Practice, Department of Public Health, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Boyle', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Søgaard', 'Affiliation': 'Research Unit of Physical Activity and Health in Work Life, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Juul-Kristensen', 'Affiliation': 'Research Unit for Musculoskeletal Function and Physiotherapy, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230, Odense, Denmark.'}]",Trials,['10.1186/s13063-020-04892-0']
2364,33264516,Safety and pharmacokinetics of bimagrumab in healthy older and obese adults with body composition changes in the older cohort.,"BACKGROUND
Bimagrumab prevents activity of myostatin and other negative regulators of skeletal muscle mass. This randomized double-blind, placebo-controlled study investigated safety, pharmacokinetics (PK), and pharmacodynamics of bimagrumab in healthy older and obese adults.
METHODS
A cohort of older adults (aged 70-85 years) received single intravenous infusions of bimagrumab 30 mg/kg (n = 6) or 3 mg/kg (n = 6) or placebo (n = 4) and was followed for 20 weeks. A second cohort of obese participants [body mass index (BMI) 30-45 kg/m 2 , aged 18-65 years] received a single intravenous infusion of bimagrumab 30 mg/kg (n = 6) or placebo (n = 2) and was followed for 12 weeks. Outcomes included the safety, tolerability, and PK of bimagrumab, in both cohorts. Measures of pharmacodynamics were performed in the older adult cohort to evaluate the effects of bimagrumab on thigh muscle volume (TMV), total lean body mass (LBM), total fat body mass, and muscle strength.
RESULTS
All 24 randomized participants completed the study. The older adults had a mean (±SD) age of 74.5 ± 3.4 years and BMI of 26.5 ± 3.5 kg/m 2 . The obese participants had a mean (±SD) age of 40.4 ± 11.8 years, weight of 98.0 ± 11.3 kg, and BMI of 34.3 ± 3.9 kg/m 2 . Adverse events in both cohorts were mostly mild. In older adults, most commonly reported adverse events were upper respiratory tract infection, rash, and diarrhoea (each 3/16, 19%). Obese participants reported muscle spasms and rash (both 5/8, 63%) most often. Non-linearity was observed in the PK concentration profiles of both cohorts due to target-mediated drug disposition. Bimagrumab 3 and 30 mg/kg increased mean (±SD) TMV (Week 4: 5.3 ± 1.8% and 6.1 ± 2.2%, vs. placebo: 0.5 ± 2.1%, both P ≤ 0.02) and LBM (Week 4: 6.0 ± 3.2%, P = 0.03 and 2.4 ± 2.2%, vs. placebo: 0.1 ± 2.4%), which were maintained longer with higher dose level, while total fat body mass (Week 4: -2.7 ± 2.9% and -1.6 ± 3.0%, vs. placebo: -2.3 ± 3.2%) decreased from baseline in older adults, with no change in muscle strength.
CONCLUSIONS
Bimagrumab was safe and well tolerated and demonstrated similar PK in older and obese adults. A single dose of bimagrumab rapidly increased TMV and LBM and decreased body adiposity in older adults. Muscle hypertrophy and fat loss were sustained with extended drug exposure.",2020,Bimagrumab 3 and 30 mg/kg increased mean,"['healthy older and obese adults', 'older adults', 'obese participants [body mass index (BMI) 30-45\xa0kg/m 2 , aged 18-65\xa0years', 'obese participants had a mean (±SD) age of 40.4\xa0±\xa011.8\xa0years, weight of 98.0\xa0±\xa011.3\xa0kg, and BMI of 34.3\xa0±\xa03.9\xa0kg/m 2 ', 'healthy older and obese adults with body composition changes in the older cohort', 'older and obese adults', 'older adults had a mean (±SD) age of 74.5\xa0±\xa03.4\xa0years and BMI of 26.5\xa0±\xa03.5\xa0kg/m 2 ', 'older adults (aged 70-85\xa0years']","['placebo', 'single intravenous infusions of bimagrumab 30\xa0mg/kg (n\xa0=\xa06) or 3\xa0mg/kg (n\xa0=\xa06) or placebo', 'TMV ', 'single intravenous infusion of bimagrumab 30\xa0mg/kg (n\xa0=\xa06) or placebo', 'bimagrumab']","['thigh muscle volume (TMV), total lean body mass (LBM), total fat body mass, and muscle strength', 'PK concentration profiles', 'muscle strength', 'Muscle hypertrophy and fat loss', 'safe and well tolerated', 'total fat body mass', 'safety, pharmacokinetics (PK', 'Adverse events', 'adverse events were upper respiratory tract infection, rash, and diarrhoea', 'LBM', 'TMV and LBM and decreased body adiposity', 'muscle spasms and rash', 'safety, tolerability, and PK of bimagrumab']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C4517698', 'cui_str': '3.9'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C3844010', 'cui_str': '3.5'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0015665', 'cui_str': 'Fat Body'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C3899948', 'cui_str': 'bimagrumab'}]",24.0,0.519157,Bimagrumab 3 and 30 mg/kg increased mean,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rooks', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Cambridge, MA, USA.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Petricoul', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Praestgaard', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bartlett', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Laurent', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}, {'ForeName': 'Ronenn', 'Initials': 'R', 'LastName': 'Roubenoff', 'Affiliation': 'Translational Medicine, Novartis Institutes for BioMedical Research, Basel, Switzerland.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12639']
2365,33264387,Number of Concussions Does Not Affect Treatment Response to Cognitive Rehabilitation Interventions Following Mild TBI in Military Service Members.,"OBJECTIVE
The study objective was to determine whether number of concussions would affect symptom improvement following cognitive rehabilitation (CR) interventions.
METHOD
Service members (N = 126) with concussion history completed a 6-week randomized control trial of CR interventions. Participants were stratified based on self-reported lifetime concussion frequency. Outcome measures included the Paced Auditory Serial Addition Test (PASAT), the Global Severity Index (GSI) from the Symptom Checklist-90-Revised, and the Key Behaviors Change Inventory (KBCI).
RESULTS
Mixed-model analyses of variance revealed a significant main effect for time on cognitive, psychological, and neurobehavioral functioning. A significant main effect for the number of concussions was observed for GSI and KBCI, but not PASAT. Interactions between the number of concussions and time were not significant for any of the outcome variables.
CONCLUSIONS
Over the 6-week interval, improvements were found for all participants across all outcome measures. Number of concussions did not affect improvements over time.",2020,"A significant main effect for the number of concussions was observed for GSI and KBCI, but not PASAT.",['Service members (N\xa0=\xa0126) with concussion history'],"['Cognitive Rehabilitation Interventions', 'CR interventions', 'cognitive rehabilitation (CR) interventions']","['Paced Auditory Serial Addition Test (PASAT), the Global Severity Index (GSI) from the Symptom Checklist-90-Revised, and the Key Behaviors Change Inventory (KBCI', 'number of concussions', 'cognitive, psychological, and neurobehavioral functioning']","[{'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0589060', 'cui_str': 'Paced auditory serial addition test'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006107', 'cui_str': 'Concussion injury of brain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",126.0,0.0854058,"A significant main effect for the number of concussions was observed for GSI and KBCI, but not PASAT.","[{'ForeName': 'Anna S', 'Initials': 'AS', 'LastName': 'Ord', 'Affiliation': 'Mid-Atlantic (VISN 6) Mental Illness Research, Education, and Clinical Center (MIRECC), Salisbury VA Healthcare System, Salisbury, NC, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Shura', 'Affiliation': 'Mid-Atlantic (VISN 6) Mental Illness Research, Education, and Clinical Center (MIRECC), Salisbury VA Healthcare System, Salisbury, NC, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Curtiss', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Armistead-Jehle', 'Affiliation': 'Concussion Clinic, Munson Army Health Center, Fort Leavenworth, KS, USA.'}, {'ForeName': 'Rodney D', 'Initials': 'RD', 'LastName': 'Vanderploeg', 'Affiliation': 'Independent Practice, St. Petersburg, FL, USA.'}, {'ForeName': 'Amy O', 'Initials': 'AO', 'LastName': 'Bowles', 'Affiliation': 'Department of Rehabilitation Medicine, Brooke Army Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'Jan E', 'Initials': 'JE', 'LastName': 'Kennedy', 'Affiliation': 'Department of Neurology, Brooke Army Medical Center, San Antonio, TX, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Tate', 'Affiliation': 'TBI and Concussion Center, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'Cooper', 'Affiliation': 'Department of Rehabilitation Medicine, Department of Psychiatry, University of Texas Health Science Center, San Antonio, TX, USA.'}]",Archives of clinical neuropsychology : the official journal of the National Academy of Neuropsychologists,['10.1093/arclin/acaa119']
2366,33264337,"A multicenter, randomized, open-label, controlled trial to evaluate the efficacy and tolerability of hydroxychloroquine and a retrospective study in adult patients with mild to moderate coronavirus disease 2019 (COVID-19).","OBJECTIVE
In this study, we evaluated the efficacy of hydroxychloroquine (HCQ) against coronavirus disease 2019 (COVID-19) via a randomized controlled trial (RCT) and a retrospective study.
METHODS
Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness. HCQ (400 mg twice for 1 d or HCQ 200 mg twice daily for 6 days) was administered. Both the study and control group received standard of care (SOC). Pharyngeal swabs and sputum were collected every other day. The proportion and time to negative viral PCR were assessed on day 14. In the retrospective study, medical records were reviewed for patients admitted before March 31, 2020.
RESULTS
There were 33 and 37 cases in the RCT and retrospective study, respectively. In the RCT, the median times to negative rRT-PCR from randomization to hospital day 14 were 5 days (95% CI; 1, 9 days) and 10 days (95% CI; 2, 12 days) for the HCQ and SOC groups, respectively (p = 0.40). On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70).
CONCLUSIONS
Neither study demonstrated that HCQ shortened viral shedding in mild to moderate COVID-19 subjects.",2020,"On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36).","['medical records were reviewed for patients admitted before March 31, 2020', 'adult patients with mild to moderate coronavirus disease 2019 (COVID-19', 'Subjects admitted to 11 designated public hospitals in Taiwan between April 1 and May 31, 2020, with COVID-19 diagnosis confirmed by pharyngeal real-time RT-PCR for SARS-CoV-2, were randomized at a 2:1 ratio and stratified by mild or moderate illness']","['standard of care (SOC', 'HCQ', 'hydroxychloroquine', 'hydroxychloroquine (HCQ']","['negative rRT-PCR', 'efficacy and tolerability', 'HCQ shortened viral shedding', 'median times to negative rRT-PCR', 'proportion and time to negative viral PCR']","[{'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}]",,0.0716663,"On day 14, 81.0% (17/21) and 75.0% (9/12) of the subjects in the HCQ and SOC groups, respectively, had undetected virus (p = 0.36).","[{'ForeName': 'Cheng-Pin', 'Initials': 'CP', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.'}, {'ForeName': 'Yi-Chun', 'Initials': 'YC', 'LastName': 'Lin', 'Affiliation': 'Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.'}, {'ForeName': 'Tsung-Chia', 'Initials': 'TC', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.'}, {'ForeName': 'Ting-Yu', 'Initials': 'TY', 'LastName': 'Tseng', 'Affiliation': 'Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.'}, {'ForeName': 'Hon-Lai', 'Initials': 'HL', 'LastName': 'Wong', 'Affiliation': 'Department of Internal Medicine, Keelung Hospital, Ministry of Health and Welfare, Keelung City, Taiwan.'}, {'ForeName': 'Cheng-Yu', 'Initials': 'CY', 'LastName': 'Kuo', 'Affiliation': 'Department of Internal Medicine, Pingtung Hospital, Ministry of Health and Welfare, Pingtung, Taiwan.'}, {'ForeName': 'Wu-Pu', 'Initials': 'WP', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, Taipei Hospital, Ministry of Health and Welfare, New Taipei City, Taiwan.'}, {'ForeName': 'Sz-Rung', 'Initials': 'SR', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Miaoli General Hospital, Ministry of Health and Welfare, Miaoli, Taiwan.'}, {'ForeName': 'Wei-Yao', 'Initials': 'WY', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Feng Yuan Hospital, Ministry of Health and Welfare, Taichung, Taiwan.'}, {'ForeName': 'Jia-Hung', 'Initials': 'JH', 'LastName': 'Liao', 'Affiliation': 'Department of Internal Medicine, Nantou Hospital, Ministry of Health and Welfare, Nantou, Taiwan.'}, {'ForeName': 'Chung-Shin', 'Initials': 'CS', 'LastName': 'Liao', 'Affiliation': 'Department of Internal Medicine, Chia Yi Hospital, Ministry of Health and Welfare, Chiayi, Taiwan.'}, {'ForeName': 'Yuan-Pin', 'Initials': 'YP', 'LastName': 'Hung', 'Affiliation': 'Department of Internal Medicine, Tainan Hospital, Ministry of Health and Welfare, Tainan City, Taiwan.'}, {'ForeName': 'Tse-Hung', 'Initials': 'TH', 'LastName': 'Lin', 'Affiliation': 'Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.'}, {'ForeName': 'Tz-Yan', 'Initials': 'TY', 'LastName': 'Chang', 'Affiliation': 'Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.'}, {'ForeName': 'Chin-Fu', 'Initials': 'CF', 'LastName': 'Hsiao', 'Affiliation': 'Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Huang', 'Affiliation': 'Department of Internal Medicine, Chang Hua Hospital, Ministry of Health and Welfare, Changhua, Taiwan.'}, {'ForeName': 'Wei-Sheng', 'Initials': 'WS', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Taichung Hospital, Ministry of Health and Welfare, Taichung, Taiwan.'}, {'ForeName': 'Chien-Yu', 'Initials': 'CY', 'LastName': 'Cheng', 'Affiliation': 'Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.'}, {'ForeName': 'Shu-Hsing', 'Initials': 'SH', 'LastName': 'Cheng', 'Affiliation': 'Department of Infectious Diseases, Taoyuan General Hospital, Ministry of Health and Welfare, Taoyuan, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0242763']
2367,33264302,Refinement of the CS6-expressing enterotoxigenic Escherichia coli strain B7A human challenge model: A randomized trial.,"BACKGROUND
Human challenge models for enterotoxigenic Escherichia coli (ETEC) facilitate vaccine down-selection. The B7A (O148:H28 CS6+LT+ST+) strain is important for vaccine development. We sought to refine the B7A model by identifying a dose and fasting regimen consistently inducing moderate-severe diarrhea.
METHODS
An initial cohort of 28 subjects was randomized (1:1:1:1) to receive B7A following an overnight fast at doses of 108 or 109 colony forming units (cfu) or a 90-minute fast at doses of 109 or 1010 cfu. A second cohort included naïve and rechallenged subjects who had moderate-severe diarrhea and were given the target regimen. Immune responses to important ETEC antigens were assessed.
RESULTS
Among subjects receiving 108 cfu of B7A, overnight fast, or 109 cfu, 90-minute fast, 42.9% (3/7) had moderate-severe diarrhea. Higher attack rates (71.4%; 5/7) occurred in subjects receiving 109 cfu, overnight fast, or 1010 cfu, 90-minute fast. Upon rechallenge with 109 cfu of B7A, overnight fast, 5/11 (45.5%) had moderate-severe diarrhea; the attack rate among concurrently challenge naïve subjects was 57.9% (11/19). Anti-CS6, O148 LPS and LT responses were modest across all groups.
CONCLUSIONS
An overnight fast enabled a reduction in the B7A inoculum dose; however, the attack rate was inconsistent and protection upon rechallenge was minimal.",2020,"Higher attack rates (71.4%; 5/7) occurred in subjects receiving 109 cfu, overnight fast, or 1010 cfu, 90-minute fast.","['28 subjects', 'A second cohort included naïve and rechallenged subjects who had moderate-severe diarrhea and were given the target regimen']",[],"['attack rate', 'Higher attack rates', 'moderate-severe diarrhea']","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]",[],"[{'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1443924', 'cui_str': 'Severe diarrhea'}]",,0.0433892,"Higher attack rates (71.4%; 5/7) occurred in subjects receiving 109 cfu, overnight fast, or 1010 cfu, 90-minute fast.","[{'ForeName': 'Kawsar R', 'Initials': 'KR', 'LastName': 'Talaat', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Chad K', 'Initials': 'CK', 'LastName': 'Porter', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Kayla M', 'Initials': 'KM', 'LastName': 'Jaep', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, MD, United States of America.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Duplessis', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Ramiro L', 'Initials': 'RL', 'LastName': 'Gutierrez', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Maciel', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, MD, United States of America.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Adjoodani', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Feijoo', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Subhra', 'Initials': 'S', 'LastName': 'Chakraborty', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Brubaker', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Stefanie A', 'Initials': 'SA', 'LastName': 'Trop', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, MD, United States of America.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Riddle', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Sabrina S', 'Initials': 'SS', 'LastName': 'Joseph', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, MD, United States of America.'}, {'ForeName': 'A Louis', 'Initials': 'AL', 'LastName': 'Bourgeois', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Prouty', 'Affiliation': 'Naval Medical Research Center, Silver Spring, MD, United States of America.'}]",PloS one,['10.1371/journal.pone.0239888']
2368,33264199,"The Effect of Breathing Exercise on Nicotine Withdrawal Symptoms, Cigarette Cravings, and Affect.","The aim of this study was to evaluate the effects of a single bout of controlled deep breathing and a ""three-part breathing"" exercise on nicotine withdrawal symptoms, cigarette cravings, and affect. A secondary aim was to determine whether autonomic nervous system activity mediates these effects. Twenty-four participants attended one practical session followed by three intervention sessions on 3 separate days: control condition, controlled deep breathing, and three-part breathing. Participants were asked to abstain from smoking for 15 hours before intervention. Nicotine withdrawal symptoms, cigarette cravings, affect, and heart rate variability were assessed preintervention and again on four occasions postintervention: immediately postintervention and every 10 minutes on three more occasions. Results revealed that the three-part breathing exercise resulted in lower negative affect scores relative to control condition and controlled deep breathing immediately after postintervention (p < .05). In addition, high-frequency heart rate variability score was significantly reduced throughout the 30-minute session.",2020,Results revealed that the three-part breathing exercise resulted in lower negative affect scores relative to control condition and controlled deep breathing immediately after postintervention (p < .05).,[],"['control condition, controlled deep breathing, and three-part breathing', 'Breathing Exercise', 'controlled deep breathing and a ""three-part breathing"" exercise']","['nicotine withdrawal symptoms, cigarette cravings', 'Nicotine withdrawal symptoms, cigarette cravings, affect, and heart rate variability', 'Nicotine Withdrawal Symptoms, Cigarette Cravings', 'high-frequency heart rate variability score']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0028047', 'cui_str': 'Nicotine withdrawal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0171755,Results revealed that the three-part breathing exercise resulted in lower negative affect scores relative to control condition and controlled deep breathing immediately after postintervention (p < .05).,"[{'ForeName': 'Thaniya', 'Initials': 'T', 'LastName': 'Klinsophon', 'Affiliation': 'Thaniya Klinsophon, BSc (Hon), Premtip Thaveeratitham, PhD, and Prawit Janwantanakul, PhD, Faculty of Allied Health Sciences, Department of Physical Therapy, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Premtip', 'Initials': 'P', 'LastName': 'Thaveeratitham', 'Affiliation': ''}, {'ForeName': 'Prawit', 'Initials': 'P', 'LastName': 'Janwantanakul', 'Affiliation': ''}]",Journal of addictions nursing,['10.1097/JAN.0000000000000367']
2369,33264200,"Nurse-Led Body-Mind-Spirit Based Relapse Prevention Intervention for People With Diagnosis of Alcohol Use Disorder at a Mental Health Care Setting, India: A Pilot Study.","BACKGROUND
Alcohol dependence is associated with alcohol-related problems and persistent vulnerability to relapse. Despite newer medications, frequent relapses continue to occur. Hence, there is a need to look at holistic approaches to deal with this problem.
OBJECTIVE
Evaluate the effectiveness of nurse-led body-mind-spirit (BMS)-based relapse prevention intervention on craving and quantity and frequency of alcohol consumption among alcohol-dependent individuals.
METHODS
Randomized control trial was adopted, and the study was conducted at a mental health care setting in India. Sixty individuals with alcohol use disorder were randomly assigned to a BMS group (n = 30) and a treatment-as-usual (TAU) group (n = 30) between June 2017 and March 2018. Subjects of both groups were initially assessed for craving and quantity and frequency of alcohol consumption. BMS subjects received seven sessions of BMS intervention and routine treatment at de-addiction wards. The interventions comprise of body, mind, and spirit strategies that aid in handling triggers, accept responsibility for their own well-being and take charge of self health. TAU group subjects received only routine treatment. All the participants were followed up over 3 months postdischarge.
RESULTS
Over 3 months of follow-up, BMS group subjects (vs. TAU group) reported significantly lesser quantity of alcohol consumption (F = 9.74, p < .001, η = .144), fewer drinking days (F = 14.04, p < .001, η = .195), lower relapse rates (14 vs. 28), and lesser craving (F = 14.01, p < .001, η = .195). Regression analysis showed that number of previous attempts (>1) and increased baseline drinking were associated with relapse.
CONCLUSION
Findings provide evidence of BMS intervention in reducing craving and drinking outcomes among alcohol-dependent individuals in India.",2020,"Over 3 months of follow-up, BMS group subjects (vs. TAU group) reported significantly lesser quantity of alcohol consumption (F = 9.74, p < .001, η = .144), fewer drinking days (F = 14.04, p < .001, η = .195), lower relapse rates (14 vs. 28), and lesser craving (F = 14.01, p < .001, η = .195).","['Sixty individuals with alcohol use disorder', 'alcohol-dependent individuals in India', 'alcohol-dependent individuals', 'People', 'mental health care setting in India']","['nurse-led body-mind-spirit (BMS)-based relapse prevention intervention', 'Nurse-Led Body-Mind-Spirit Based Relapse Prevention Intervention', 'BMS intervention', 'treatment-as-usual (TAU', 'TAU', 'BMS']","['lower relapse rates', 'quantity of alcohol consumption', 'craving and drinking outcomes', 'craving and quantity and frequency of alcohol consumption', 'lesser craving']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0301611', 'cui_str': 'Distilled spirits'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439092', 'cui_str': '<'}]",30.0,0.0458355,"Over 3 months of follow-up, BMS group subjects (vs. TAU group) reported significantly lesser quantity of alcohol consumption (F = 9.74, p < .001, η = .144), fewer drinking days (F = 14.04, p < .001, η = .195), lower relapse rates (14 vs. 28), and lesser craving (F = 14.01, p < .001, η = .195).","[{'ForeName': 'Siu-Man', 'Initials': 'SM', 'LastName': 'Ng', 'Affiliation': 'Siu-man Ng, PhD, RSW, RCMP, Cecilia L. W. Chan, PhD, RSW, JP, Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong. Sreevani Rentala, PhD, Department of Psychiatric Nursing, Dharwad Institute of Mental Health and Neuroscience, Dharwad, Karnataka, India. Raghavendra Bheemappa Nayak, MD, Department of Psychiatry, Dharwad Institute of Mental Health and Neuroscience, Dharwad, Karnataka, India.'}, {'ForeName': 'Sreevani', 'Initials': 'S', 'LastName': 'Rentala', 'Affiliation': ''}, {'ForeName': 'Cecilia L W', 'Initials': 'CLW', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Raghavendra Bheemappa', 'Initials': 'RB', 'LastName': 'Nayak', 'Affiliation': ''}]",Journal of addictions nursing,['10.1097/JAN.0000000000000368']
2370,33264161,"Cool Crosslinking: Riboflavin at 4°C for Pain Management After Crosslinking for Keratoconus Patients, A Randomized Clinical Trial.","PURPOSE
To explore corneal cooling as a method of pain management in corneal-accelerated collagen cross-linking.
METHODS
This was a prospective and interventional randomized clinical trial registered in the National Institutes of Health Clinical Trials through the identifier NCT030760770. The research was conducted at the Institute of Ophthalmology ""Conde de Valenciana."" A total of 98 patients were randomly assigned to one of the following 2 groups: cold riboflavin (4°C) group or control group (riboflavin at room temperature). The inclusion criteria were patients of any sex, older than 18 years of age with keratoconus diagnosis who needed management with cross-linking in both eyes because of the evidence of progression. The exclusion criteria were patients who had cross-linking without epithelial debridement, unilateral cross-linking, or any other ocular pathologies besides keratoconus and any cognitive incapacity that would make the understanding of the pain test difficult. The main outcome measures were pain, tearing, photophobia, foreign body sensation, and irritation.
RESULTS
At 2 hours post-op, pain in the case and control groups was 3.80 ± 3.00 and 8.08 ± 2.21 (P < 0.05), tearing was 1.56 ± 1.96 and 8.29 ± 2.42 (P < 0.05), photophobia was 5.44 ± 3.57 and 7.83 ± 2.64 (P < 0.05), foreign body sensation was 2.20 ± 2.78 and 6.54 ± 2.73 (P < 0.05), and irritation was 3.48 ± 2.98 and 6.79 ± 3.00 (P < 0.05), respectively. A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]).
CONCLUSIONS
This study demonstrated that pain and associated symptoms decreased significantly in the riboflavin 4°C group.",2021,"A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]).
","['98 patients', 'patients who had cross-linking without epithelial debridement, unilateral cross-linking, or any other ocular pathologies besides keratoconus and any cognitive incapacity', 'The inclusion criteria were patients of any sex, older than 18 years of age with keratoconus diagnosis who needed management with cross-linking in both eyes because of the evidence of progression']","['Cool Crosslinking: Riboflavin', 'riboflavin', 'cold riboflavin (4°C) group or control group (riboflavin at room temperature']","['pain and associated symptoms', 'photophobia', 'pain, tearing, photophobia, foreign body sensation, and irritation', 'pain values', 'Pain Management', 'pain', 'foreign body sensation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0229118', 'cui_str': 'Structure of both eyes'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0085636', 'cui_str': 'Photophobia'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",98.0,0.0770776,"A statistical significant difference was maintained in pain values on day 1 (2.79 ± 3.09 and 4.91 ± 3.27 [P < 0.05]), 2 (2.54 ± 2.41 and 4.00 ± 2.43 [P < 0.05]), and 4 (0.45 ± 0.76 and 1.22 ± 1.67 [P < 0.05]).
","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Toro-Giraldo', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Morales Flores', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Santana-Cruz', 'Affiliation': 'Department of Optometry, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Ramirez-Miranda', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Navas', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Olivo-Payne', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lichtinger', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Jimenez-Corona', 'Affiliation': 'Department of Ocular Epidemiology and Public Health, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}, {'ForeName': 'Enrique O', 'Initials': 'EO', 'LastName': 'Graue-Hernández', 'Affiliation': 'Department of Cornea, External Disease and Refractive Surgery, Institute of Ophthalmology ""Conde de Valenciana,"" Mexico City, Mexico.'}]",Cornea,['10.1097/ICO.0000000000002484']
2371,33264101,Correction: Improving Nutrition and Activity Behaviors Using Digital Technology and Tailored Feedback: Protocol for the Tailored Diet and Activity (ToDAy) Randomized Controlled Trial.,[This corrects the article DOI: 10.2196/12782.].,2020,[This corrects the article DOI: 10.2196/12782.].,[],"['Digital Technology and Tailored Feedback', 'Tailored Diet and Activity (ToDAy']",['Nutrition and Activity Behaviors'],[],"[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0310367', 'cui_str': 'Today'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0380661,[This corrects the article DOI: 10.2196/12782.].,"[{'ForeName': 'Rhiannon E', 'Initials': 'RE', 'LastName': 'Halse', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Charlene L', 'Initials': 'CL', 'LastName': 'Shoneye', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Pollard', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jonine', 'Initials': 'J', 'LastName': 'Jancey', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Scott', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'Pratt', 'Affiliation': 'Cancer Council WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Satvinder S', 'Initials': 'SS', 'LastName': 'Dhaliwal', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Norman', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Leon M', 'Initials': 'LM', 'LastName': 'Straker', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Boushey', 'Affiliation': 'Cancer Epidemiology Program, University of Hawaii Cancer Center, Honolulu, HI, United States.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Delp', 'Affiliation': 'School of Electrical and Computer Engineering, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Fengqing', 'Initials': 'F', 'LastName': 'Zhu', 'Affiliation': 'School of Electrical and Computer Engineering, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Harray', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Szybiak', 'Affiliation': 'Cancer Council WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Finch', 'Affiliation': 'Cancer Council WA, Perth, Western Australia, Australia.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'McVeigh', 'Affiliation': 'School of Occupational Therapy, Speech Therapy & Social Work, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mullan', 'Affiliation': 'Health Psychology & Behavioural Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, University of Newcastle, Callaghan, New South Wales, Australia.'}, {'ForeName': 'Syed Aqif', 'Initials': 'SA', 'LastName': 'Mukhtar', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Kieran N', 'Initials': 'KN', 'LastName': 'Edwards', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Janelle D', 'Initials': 'JD', 'LastName': 'Healy', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Kerr', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western Australia, Australia.'}]",JMIR research protocols,['10.2196/25940']
2372,33264098,"Randomized Controlled Trial of Mindfulness - Based Intervention For Student Depression, Anxiety and Stress: Observations on a Disrupted Campus.","BACKGROUND
Background: University students are experiencing higher levels of distress and mental health disorders. In addressing mental health needs, web-based interventions have shown increasing promise to overcome geographic distances and high student-to-counselor ratios, leading to the potential for wider implementation. The Mindfulness Virtual Community (MVC) program, a web based program, guided by mindfulness and cognitive behavioural therapy principles, is among efforts aimed at effectively and efficiently reducing symptoms of depression, anxiety, and perceived stress in students.
OBJECTIVE
Objective: This study's aim was to evaluate the efficacy of an 8-week MVC program in reducing depression, anxiety, and perceived stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a large Canadian university. Guided by two prior randomized controlled trials (RCTs) that each demonstrated efficacy when conducted during regular university operations, the current study coincided with a university-wide labour strike. Nonetheless, the students' response to an online mental health program on a disrupted campus can provide useful information for anticipating the impact of other disruptions, including those related to COVID-19, currently and in a foreseeable future.
METHODS
Methods: In this parallel arm randomized controlled trial (RCT), 154 students were randomly allocated to an 8-week MVC intervention (n= 76) or a waitlist control (WLC) condition (n= 78). The MVC intervention included (1) educational and mindfulness video modules, (2) anonymous peer-peer discussions, and (3) anonymous, group-based, professionally-guided, 20-min videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR(1) covariance structure were used to evaluate the impact of intervention, with outcome evaluations performed on both an intention to treat (ITT) and per protocol (PP) basis.
RESULTS
Results: Participants (n= 154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between MVC and WLC on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the MVC-WLC groups. Results under both ITT and PP approaches indicated that except for PSS (ITT: β= -2.31, P= .03; PP: β= -2.38, P= .03), there were no statistically significant between group differences in PHQ-9 (ITT: β= -0.44, P= 0.64; PP: β= -0.62, P= .053), BAI (ITT: β= -2.06, P= .31; PP: β= -2.32, P= .27), and FFMQ-SF (ITT: β= 1.33, P= .43; PP: β= 1.44, P= .41) compared to WLC.
CONCLUSIONS
Conclusions: During a university labour strike, the MVC program led to statistically significant reductions in PSS compared to WLC, but no other significant between group differences. Comparisons with previous cycles of intervention testing, undertaken during non-disrupted university operations, when efficacy was demonstrated, are discussed.
CLINICALTRIAL
Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275.",2020,"There were no statistically significant differences at baseline between MVC and WLC on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the MVC-WLC groups.","['University students', 'Methods', '154 students', 'Results: Participants (n= 154) included 35 males and 117 females with a mean age of 23.1 years', 'undergraduate students at a large Canadian university']","['Mindfulness - Based Intervention', 'MVC intervention', 'MVC intervention included (1) educational and mindfulness video modules, (2) anonymous peer-peer discussions, and (3) anonymous, group-based, professionally-guided, 20-min videoconferences', 'waitlist control (WLC) condition', 'Mindfulness Virtual Community (MVC) program, a web based program, guided by mindfulness and cognitive behavioural therapy principles', 'MVC program']","['depression, anxiety, and perceived stress (primary outcomes', 'distress and mental health disorders', 'Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF', 'PSS']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]",154.0,0.105734,"There were no statistically significant differences at baseline between MVC and WLC on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the MVC-WLC groups.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ritvo', 'Affiliation': 'School of Kinesiology and Health Science, Faculty of Health, York University, Toronto, CA.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, CA.'}, {'ForeName': 'Christo', 'Initials': 'C', 'LastName': 'El Morr', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, CA.'}, {'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Pirbaglou', 'Affiliation': 'School of Kinesiology and Health Science, Faculty of Health, York University, Toronto, CA.'}, {'ForeName': 'Rahim', 'Initials': 'R', 'LastName': 'Moineddin', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, CA.'}]",JMIR mental health,['10.2196/23491']
2373,33270316,What Do These Sounds Tell Us About the therapeutic Alliance: Acoustic Markers as Predictors of Alliance.,"Predicting the trajectories of alliance formation that the patient is likely to establish with the therapist during treatment, even before their first meeting, can help prevent the potentially harmful consequences of deterioration in alliance, such as poor outcome, and premature dropout. The present study aimed to examine the ability of four pretreatment acoustic markers to predict the alliance that is likely to be formed in the course of treatment: F0-span, speech rate, pause proportion, and jitter. Data from 560 observations of 38 patients were collected as part of an ongoing randomized clinical trial of short-term psychotherapy for major depressive disorder. The acoustic markers were measured using high-quality recordings at baseline, before the patient and therapist ever met or had any type of communication. A multilevel model was used to examine the ability of the four acoustic markers to predict the slopes of alliance formation in the course of treatment, all markers being introduced in the same model. The clinical utility of the acoustic markers was explored in two case studies. The model explained 22% of the variance in alliance formation. Higher levels of both jitter and pause proportion at baseline predicted less strengthening of the alliance in the course of treatment. The findings, which should be replicated in larger samples, suggest that much of the therapeutic alliance can be predicted based on the acoustic characteristics of the patient's voice in the first 3 minutes of their intake, before they even meet their therapist.",2020,Higher levels of both jitter and pause proportion at baseline predicted less strengthening of the alliance in the course of treatment.,"['Data from 560 observations of 38 patients', 'for major depressive disorder']",['short-term psychotherapy'],[],"[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0033970', 'cui_str': 'Brief Psychotherapy'}]",[],38.0,0.0312188,Higher levels of both jitter and pause proportion at baseline predicted less strengthening of the alliance in the course of treatment.,"[{'ForeName': 'Aviv', 'Initials': 'A', 'LastName': 'Nof', 'Affiliation': 'University of Haifa, Tel Aviv University.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Amir', 'Affiliation': 'University of Haifa, Tel Aviv University.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'University of Haifa, Tel Aviv University.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Zilcha Mano', 'Affiliation': 'University of Haifa, Tel Aviv University.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2534']
2374,33270307,Validation of the VT-LVAD Score for Prediction of Late VAs in LVAD Recipients.,"INTRODUCTION
Objectives This study sought to validate the performance of the VT-LVAD risk model in predicting late ventricular arrhythmias (VAs) in patients after left-ventricular assist device (LVAD) implantation. Background The need for ICD-implantation in LVAD-recipients is not well studied. A better selection of the patients with high risk for late VAs could lead to a more targeted ICD-implantation or replacement. Methods The study evaluated the performance of the VT-LVAD prognostic score [VAs prior LVAD, no ACE-inhibitor in medication, heart failure duration >12 months, early VAs post LVAD implantation, atrial fibrillation prior LVAD, idiopathic dilated cardiomyopathy] for the endpoint of the occurrence of late VAs in 357 LVAD-patients in Heart Centre of Leipzig. Results From the initial 460 patients, 357 (age 58 ± 10 years; left ventricular ejection fraction: 20 ± 6%; HeartWare: 50%; HeartMate III: 42%) were assigned to four risk groups according to their VT-LVAD-score varying from low risk to very high risk. After 25 months, late VAs occurred in 130 patients. The VT-LVAD score was an independent predictor of late VAs (multivariate analysis; p= <0.001; goodness-of-tip p=.347, OR 4.8). While there was no statistically significant difference between the low and intermediate risk group, risk stratification for patients with high risk and very high risk performed more accurately (pairwise comparison p=.005 and p<0.001, respectively). Conclusions The VT-LVAD-score predicted accurately the occurrence of late VAs in high risk LVAD recipients in a large external cohort of LVAD recipients supporting its utility for more targeted ICD implantations. This article is protected by copyright. All rights reserved.",2020,"The VT-LVAD score was an independent predictor of late VAs (multivariate analysis; p= <0.001; goodness-of-tip p=.347, OR 4.8).","['LVAD Recipients', 'patients after left-ventricular assist device (LVAD) implantation', '460 patients, 357', 'patients with high risk for late VAs', '357 LVAD-patients in Heart Centre of Leipzig', 'age 58 ± 10 years; left ventricular ejection fraction: 20 ± 6%; HeartWare: 50%; HeartMate III: 42']",[],"['VT-LVAD prognostic score [VAs prior LVAD, no ACE-inhibitor in medication, heart failure duration >12 months, early VAs post LVAD implantation, atrial fibrillation prior LVAD, idiopathic dilated cardiomyopathy', 'VT-LVAD score', 'late VAs']","[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0439070', 'cui_str': 'III'}]",[],"[{'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C0449821', 'cui_str': 'Prognostic score'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1449563', 'cui_str': 'Primary idiopathic dilated cardiomyopathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",,0.0275606,"The VT-LVAD score was an independent predictor of late VAs (multivariate analysis; p= <0.001; goodness-of-tip p=.347, OR 4.8).","[{'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Darma', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre of Leipzig, Germany.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Arya', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre of Leipzig, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Dagres', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre of Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kühl', 'Affiliation': 'University Hospitals of Coventry and Warwickshire, United Kingdom.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Department of Cardiac Electrophysiology, Heart Centre of Leipzig, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Eifert', 'Affiliation': 'Department of Cardiac Surgery, Heart Centre of Leipzig, Germany.'}, {'ForeName': 'Diyar', 'Initials': 'D', 'LastName': 'Saeed', 'Affiliation': 'Department of Cardiac Surgery, Heart Centre of Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borger', 'Affiliation': 'Department of Cardiac Surgery, Heart Centre of Leipzig, Germany.'}, {'ForeName': 'Raphaël P', 'Initials': 'RP', 'LastName': 'Martins', 'Affiliation': 'Service de Cardiologie et Maladies Vasculaires, CHU Rennes, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'Service de Cardiologie et Maladies Vasculaires, CHU Rennes, Rennes, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Galand', 'Affiliation': 'Service de Cardiologie et Maladies Vasculaires, CHU Rennes, Rennes, France.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14827']
2375,33270306,"Results from the Prospective, Multicenter AMBULATE-CAP Trial: Reduced Use of Urinary Catheters and Protamine with Hemostasis via the Mid-Bore Venous Vascular Closure System (Vascade MVP) Following Multi-access Cardiac Ablation Procedures.","INTRODUCTION
Manual compression (MC), historically the most common method to achieve hemostasis after percutaneous vascular procedures, is time consuming, requires prolonged bedrest, and is uncomfortable for patients and clinicians. Recent studies demonstrate the efficacy and safety of vascular closure devices and suggest shorter times to hemostasis and patient ambulation compared with MC. The current study evaluated the feasibility of the VASCADE® venous vascular closure system (VVCS) while allowing for urinary catheter (UC) elimination, and elimination of protamine and/or same calendar day discharge (SCDD).
METHODS AND RESULTS
In this prospective, multicenter trial, patients were enrolled and assigned to the following groups: no UC, no protamine, and/or SCDD (no co-enrollment in no protamine and SCDD). After completing the catheter-based cardiac procedure, access sites were closed using the VVCS. Outcomes included final hemostasis (all sites) without major access site-related complications at 30 days, rates of access site closure-related complications, device success, and study group success. All 168 patients had hemostasis without major access site-related complications through 30 days. In the no UC group, 160/164 (97.6%) patients did not receive a UC. Additionally, 39/41 (95.1%) patients received heparin without protamine reversal and no access site bleeding-related ambulation delays, and 18/18 (100%) patients were discharged on the same day. There were no major access site closure-related complications, few minor complications, and adverse events were generally mild and well managed.
CONCLUSIONS
The VVCS was effective for achieving hemostasis following catheter-based procedures; access site closure-related complications and adverse events were well managed. This article is protected by copyright. All rights reserved.",2020,The VVCS was effective for achieving hemostasis following catheter-based procedures; access site closure-related complications and adverse events were well managed.,['168 patients had hemostasis without major access site-related complications through 30 days'],"['no UC, no protamine, and/or SCDD (no co-enrollment in no protamine and SCDD', 'VASCADE® venous vascular closure system (VVCS', 'VVCS', 'Urinary Catheters and Protamine with Hemostasis via the Mid-Bore Venous Vascular Closure System (Vascade MVP', 'heparin', 'Manual compression (MC']","['final hemostasis (all sites) without major access site-related complications at 30 days, rates of access site closure-related complications, device success', 'no major access site closure-related complications, few minor complications, and adverse events', 'urinary catheter (UC) elimination, and elimination of protamine and/or same calendar day discharge (SCDD', 'access site bleeding-related ambulation delays']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C2945608', 'cui_str': 'Bore'}, {'cui': 'C0026267', 'cui_str': 'Mitral valve prolapse syndrome'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0589360', 'cui_str': 'Site of access'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",168.0,0.181182,The VVCS was effective for achieving hemostasis following catheter-based procedures; access site closure-related complications and adverse events were well managed.,"[{'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Al-Ahmad', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX.""}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'The Valley Health System, Ridgewood, NJ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'DeLurgio', 'Affiliation': ""Emory Heart and Vascular Center, Emory Saint Joseph's Hospital, Atlanta, GA.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Joseph Gallinghouse', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX.""}, {'ForeName': 'Rodney P', 'Initials': 'RP', 'LastName': 'Horton', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX.""}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Preminger', 'Affiliation': 'The Valley Health System, Ridgewood, NJ.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'David Burkhardt', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natale', 'Affiliation': ""Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX.""}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14828']
2376,33270288,Long-term effectiveness of a fundamental motor skill intervention in Belgian children: A 6-year follow-up.,"The aim of this study was (1) to examine the long-term effectiveness of the 'Multimove for Kids' program, a 30-week fundamental motor skill intervention (approximately 1 hour per week) for typically developing children between 3 and 8 years, and (2) to determine the influence of participation in organized sports on motor competence (MC) six years after the intervention. Of the 992 children who took part in the 'Multimove' program, 399 (intervention group: N=228, control group: N=171) were tested again at 6-year follow-up. MC was measured with the Test of Gross Motor Development, 2 nd Edition. To examine the long-term impact of 'Multimove' on MC and the effect of participation in organized sports a latent growth curve analysis was conducted. After the 30-week intervention, the intervention group outperformed the control group (β=5.57, p<.001). However, when the entire study period, including the 6-year follow-up, was considered, the intervention group made less progress in MC than the control group (β=-0.41, p<.05). Looking at the engagement in organized sports, it was found that years of experience before the intervention had no significant influence on the evolution of MC over time, whereas a positive effect was observed for children's average sports participation (h/week) during the 6-year retention period (β=0.14, p<.001). Finally, children practicing predominantly object control-oriented sports during retention, obtained slightly better MC scores at follow-up (β=0.01, p<.01). The effect of the 'Multimove' intervention does not have a long-term effect on the development of MC. However, participation in organized sports has a positive influence on MC evolution over time.",2020,"After the 30-week intervention, the intervention group outperformed the control group (β=5.57, p<.001).","['Belgian children', ""992 children who took part in the 'Multimove' program, 399 (intervention group: N=228, control group: N=171) were tested again at 6-year follow-up""]",['fundamental motor skill intervention'],['MC scores'],"[{'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",992.0,0.020498,"After the 30-week intervention, the intervention group outperformed the control group (β=5.57, p<.001).","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Coppens', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Rommers', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Bardid', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Frederik J A', 'Initials': 'FJA', 'LastName': 'Deconinck', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'De Martelaer', 'Affiliation': 'Department of Movement and Sport Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': ""D'Hondt"", 'Affiliation': 'Department of Movement and Sport Sciences, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Lenoir', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, Belgium.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13898']
2377,33270229,The efficiency of mirror therapy on drop foot in Multiple Sclerosis Patients.,"Although the effectiveness of mirror therapy (MT) has been proved in stroke persons, there is no scientific evidence about the results in people with Multiple Sclerosis. The aim was to investigate whether adding MT to exercise training and neuromuscular electrical stimulation (NMES) has any effect on clinical measurements, mobility and functionality in people with Multiple Sclerosis (MS).
METHODS
Ambulatory people with MS, with unilateral drop foot were included. MT group (n=13) applied bilateral ankle exercise program with mirror following NMES for 3 days a week at hospital and exercise program for 2 days a week at home. Control group (n=13) performed same treatment without mirror box (6 weeks). The later 6 weeks both groups performed only exercise program. Clinical measurements included proprioception, muscle tone of plantar flexor muscles (MAS), muscle strength of dorsiflexor, ankle angular velocity, range of motion (ROM) of ankle. Functionality (Functional Independence Measurement-FIM), mobility (Rivermead Mobility Index-RMI), ambulation (Functional Ambulation Scale-FAS), duration of stair climb test, and 25 feet walking velocity were assessed at the beginning, in 6 th and 12 th weeks.
RESULTS
More positive improvements were obtained in MT group than control group in terms of range of motion (0.012), muscle strength (0.008), proprioception (0.001), 25-feet walking duration (0.015), step test duration (0.001), FAS (0.005), RMI (0.001) and FIM (0.001) after 6 weeks treatment. It was seen that this improvement maintained to 12 th week on all clinical and functional measurements (p<0.05).
CONCLUSION
The trial revealed that adding MT to exercise training and NMES has more beneficial effects on clinical measurements, mobility and functionality in people with Multiple Sclerosis with unilateral drop foot.",2020,"More positive improvements were obtained in MT group than control group in terms of range of motion (0.012), muscle strength (0.008), proprioception (0.001), 25-feet walking duration (0.015), step test duration (0.001), FAS (0.005), RMI (0.001) and FIM (0.001) after 6 weeks treatment.","['stroke persons', 'Multiple Sclerosis Patients', 'Ambulatory people with MS, with unilateral drop foot were included', 'people with Multiple Sclerosis with unilateral drop foot', 'people with Multiple Sclerosis', 'people with Multiple Sclerosis (MS']","['mirror therapy (MT', 'bilateral ankle exercise program with mirror following NMES', 'mirror therapy', 'MT', 'MT to exercise training and neuromuscular electrical stimulation (NMES']","['Functionality (Functional Independence Measurement-FIM), mobility (Rivermead Mobility Index-RMI), ambulation (Functional Ambulation Scale-FAS), duration of stair climb test, and 25 feet walking velocity', 'muscle strength', 'FAS', 'RMI', '25-feet walking duration', 'proprioception, muscle tone of plantar flexor muscles (MAS), muscle strength of dorsiflexor, ankle angular velocity, range of motion (ROM) of ankle']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0085684', 'cui_str': 'Foot-drop'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0454369', 'cui_str': 'Ankle exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015683', 'cui_str': 'Fatty-acid synthase'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",,0.0512992,"More positive improvements were obtained in MT group than control group in terms of range of motion (0.012), muscle strength (0.008), proprioception (0.001), 25-feet walking duration (0.015), step test duration (0.001), FAS (0.005), RMI (0.001) and FIM (0.001) after 6 weeks treatment.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tekeoglu', 'Affiliation': 'Fenerbahce University, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Yeldan', 'Affiliation': 'Istanbul University-Cerrahpasa, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation.'}, {'ForeName': 'Arzu Razak', 'Initials': 'AR', 'LastName': 'Ozdincler', 'Affiliation': 'Biruni University, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Saip', 'Affiliation': 'Istanbul University-Cerrahpasa, Medical School of Cerrahpasa, Department of Neurology.'}]",Acta neurologica Scandinavica,['10.1111/ane.13385']
2378,33270205,The Effect of Probiotics Supplementation on Gut Microbiota After Helicobacter pylori Eradication: A Multicenter Randomized Controlled Trial.,"INTRODUCTION
Helicobacter pylori eradication therapy may lead to the perturbation of gut microbiota. We aim to investigate the impact of probiotics on eradication rate and gut microbiota during eradication therapy.
METHODS
A total of 162 patients receiving bismuth quadruple therapy were enrolled and randomly assigned to groups given probiotics (n = 83) or placebo (n = 79) for 4 weeks. Fecal samples were collected before treatment and 2, 4, 6, and 8 weeks after eradication therapy. Gut microbiota was analyzed by 16S rRNA high-throughput sequencing.
RESULTS
The eradication rates in the placebo and probiotics group were 82.43% and 87.01%, respectively (P > 0.05). Compared with baseline, alpha and beta diversity was significantly altered 2 weeks after eradication in both groups, which was restored at week 8. There were no significant differences in diversity between the two groups. H. pylori eradication therapy resulted in enrichment of some detrimental bacteria taxa such as Shigella, Klebsiella, and Streptococcus, while probiotics supplementation could rapidly restore these taxa levels after eradication and increase the taxa of Bacillus and Lactobacillales. Functional analysis revealed that lipopolysaccharide biosynthesis and polymyxin resistance pathways were significantly enriched after eradication, while probiotics supplementation mainly enriched the cofactors and vitamins metabolism pathways. Increased relative abundances of Roseburia and Dialister were associated with the positive eradication outcome.
CONCLUSIONS
Probiotics supplementation might help to construct a beneficial profile of gut microbiota after eradication therapy. Specific bacteria taxa are associated with H. pylori eradication outcome. These findings may be of value in rational use of probiotics during H. pylori eradication.
TRIAL REGISTRATION
Chinese Clinical Trial Registry, ChiCTR1900022116.",2020,"Functional analysis revealed that lipopolysaccharide biosynthesis and polymyxin resistance pathways were significantly enriched after eradication, while probiotics supplementation mainly enriched the cofactors and vitamins metabolism pathways.",['162 patients receiving bismuth quadruple therapy'],"['Probiotics supplementation', 'Probiotics Supplementation', 'placebo', 'probiotics']","['diversity', 'Gut Microbiota', 'eradication rate and gut microbiota', 'Fecal samples', 'alpha and beta diversity', 'relative abundances of Roseburia and Dialister', 'Gut microbiota', 'eradication rates']","[{'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C1008539', 'cui_str': 'Dialister'}]",162.0,0.0988209,"Functional analysis revealed that lipopolysaccharide biosynthesis and polymyxin resistance pathways were significantly enriched after eradication, while probiotics supplementation mainly enriched the cofactors and vitamins metabolism pathways.","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Department of Gastroenterology, Chongqing Iron and Steel General Hospital, Chongqing, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Tian', 'Affiliation': ""Department of Gastroenterology, Nanchuan People's Hospital, Nanchuan, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, 958 Hospital of PLA, Chongqing, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'He', 'Affiliation': ""Department of Gastroenterology, Chongqing Fifth People's Hospital, Chongqing, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of North Sichuan Medical College, Nanchong, China.'}, {'ForeName': 'Luo', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Chengdu Medical College, Chengdu, China.'}, {'ForeName': 'Guoce', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'En', 'Initials': 'E', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Sumin', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China. garinfly@163.com.'}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Xinqiao Hospital, Third Military Medical University, Chongqing, China. Yangshiming@tmmu.edu.cn.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00372-9']
2379,33270145,"Nicotine delivery and user reactions to Juul EU (20 mg/ml) compared with Juul US (59 mg/ml), cigarettes and other e-cigarette products.","RATIONALE
The degree to which the EU version of Juul with 20 mg/ml nicotine (Juul EU) delivers nicotine to users is likely to determine its treatment potential.
OBJECTIVES
To compare the pharmacokinetic profile and user ratings of Juul EU, Juul US (59 mg/ml nicotine), cigarettes and other e-cigarette (EC) products.
METHODS
In a within-subjects crossover design, 18 vapers used, at separate sessions, their own brand cigarette (OBC), Juul US and Juul EU for 5 min ad libitum, after overnight abstinence. Seven of the participants also tested eight other EC previously. Blood samples were taken at baseline and 2, 4, 6, 8, 10 and 30 min after initiating product use. Products were rated on a range of characteristics.
RESULTS
Juul EU delivered less nicotine than OBC (t(13) = -4.64 p < .001) and than Juul US (t(13) = -6.40, p < .001): AUC 0 ≥ 30 77.3, 324.8 and 355.9, respectively. Maximum nicotine concentration (C max ) was also much lower for Juul EU than Juul US (z = -3.59, p < .001): C max 3.8 ng/ml vs 21.1 ng/ml, respectively. Juul EU was perceived to relieve urges to smoke less than Juul US (z = -2.29, p = .022) and to provide less nicotine (z = -2.57. p = 0.010). Juul EU delivered less nicotine than refillable EC (C max : t(6) = 3.02, p = 0.023; AUC 0 ≥ 30 : z = -2.20, p = 0.028) and also less than cig-a-like EC, though the difference did not reach significance (C max : t(6) = 2.49, p = 0.047; AUC 0 ≥ 30 : z = -1.99, p = 0.046). Subjective ratings of Juul EU and other EC products were similar.
CONCLUSIONS
Juul EU delivers much less nicotine to users than Juul US, and also less than refillable EC products. It may thus have more limited potential to help smokers quit.",2020,"Juul EU delivered less nicotine than refillable EC (C max : t(6) = 3.02, p = ",[],"['Juul EU, Juul US (59\xa0mg/ml nicotine), cigarettes and other e-cigarette (EC) products', 'Juul with 20\xa0mg/ml nicotine (Juul EU', 'Nicotine delivery and user reactions to Juul EU (20\xa0mg/ml) compared with Juul US', 'nicotine']","['Maximum nicotine concentration (C max ', 'Subjective ratings of Juul EU and other EC products']",[],"[{'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}]",,0.0420629,"Juul EU delivered less nicotine than refillable EC (C max : t(6) = 3.02, p = ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': ""Health and Lifestyle Research Unit, Queen Mary University of London, 2 Stayner's Road, London, E14AH, UK. a.phillips-waller@qmul.ac.uk.""}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': ""Health and Lifestyle Research Unit, Queen Mary University of London, 2 Stayner's Road, London, E14AH, UK.""}, {'ForeName': 'Katie Myers', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': ""Health and Lifestyle Research Unit, Queen Mary University of London, 2 Stayner's Road, London, E14AH, UK.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""Health and Lifestyle Research Unit, Queen Mary University of London, 2 Stayner's Road, London, E14AH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': ""Health and Lifestyle Research Unit, Queen Mary University of London, 2 Stayner's Road, London, E14AH, UK.""}]",Psychopharmacology,['10.1007/s00213-020-05734-2']
2380,33270142,"Effect of cervical headgear on dental arch area, shape and interarch dimensions : A randomized study.","PURPOSE
The goal was to study the effects of early cervical headgear treatment on maxillary and mandibular dental arch area, shape and interarch dimensions.
METHODS
The total study group comprised 67 children aged 7.6 years (standard deviation 0.3) with Angle class II malocclusion collected between 1992 and 1996. The children were randomly divided into two groups of equal size. In the first group, cervical headgear treatment was started immediately and undertaken for 2 years. The remaining patients served as untreated controls. Dental casts were taken and scanned at the beginning of treatment (T0) and at the 2‑year (T1) and 4‑year follow-up (T2). Three-dimensional landmarks describing the positions of maxillary and mandibular incisors, canines, first and second premolars and first molars were used to calculate and visualize the maxillary and mandibular dental arch area and shape using the polynomial equation y = Ax 6 + Bx 2 .
RESULTS
Significant changes in the shape and area of both maxillary and mandibular dental arches were induced with cervical headgear. The headgear increased dental arch area, sagittal dimensions at the mid-sagittal line and transversal dimensions at all of the measured levels in both dental arches compared to the control group.
CONCLUSIONS
Cervical headgear is an effective treatment device to gain space in both dental arches. Furthermore, when used as an early phase treatment, relapse is relatively small compared to the gained space.",2020,"The headgear increased dental arch area, sagittal dimensions at the mid-sagittal line and transversal dimensions at all of the measured levels in both dental arches compared to the control group.
",['67\xa0children aged 7.6\xa0years (standard deviation 0.3) with Angle class\xa0II malocclusion collected between 1992 and 1996'],"['early cervical headgear treatment', 'cervical headgear']","['headgear increased dental arch area, sagittal dimensions', 'dental arch area, shape and interarch dimensions ', 'shape and area of both maxillary and mandibular dental arches']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C3714535', 'cui_str': 'Malocclusion, Angle class II'}, {'cui': 'C0456592', 'cui_str': '1992'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0011325', 'cui_str': 'Dental arch structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]",,0.016833,"The headgear increased dental arch area, sagittal dimensions at the mid-sagittal line and transversal dimensions at all of the measured levels in both dental arches compared to the control group.
","[{'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Heino', 'Affiliation': 'Research Unit of Oral Health Sciences, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Heta', 'Initials': 'H', 'LastName': 'Kokko', 'Affiliation': 'Research Unit of Oral Health Sciences, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Vuollo', 'Affiliation': 'Research Unit of Oral Health Sciences, Faculty of Medicine, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Pertti', 'Initials': 'P', 'LastName': 'Pirttiniemi', 'Affiliation': 'Research Unit of Oral Health Sciences, Faculty of Medicine, University of Oulu, Oulu, Finland. pertti.pirttiniemi@oulu.fi.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00264-0']
2381,33270123,Effect of Pharmacogenetic Testing for Statin Myopathy Risk vs Usual Care on Blood Cholesterol: A Randomized Clinical Trial.,"Importance
Nonadherence to statin guidelines is common. The solute carrier organic anion transporter family member 1B1 (SLCO1B1) genotype is associated with simvastatin myopathy risk and is proposed for clinical implementation. The unintended harms of using pharmacogenetic information to guide pharmacotherapy remain a concern for some stakeholders.
Objective
To determine the impact of delivering SLCO1B1 pharmacogenetic results to physicians on the effectiveness of atherosclerotic cardiovascular disease (ASCVD) prevention (measured by low-density lipoprotein cholesterol [LDL-C] levels) and concordance with prescribing guidelines for statin safety and effectiveness.
Design, Setting, and Participants
This randomized clinical trial was performed from December 2015 to July 2019 at 8 primary care practices in the Veterans Affairs Boston Healthcare System. Participants included statin-naive patients with elevated ASCVD risk. Data analysis was performed from October 2019 to September 2020.
Interventions
SLCO1B1 genotyping and results reporting to primary care physicians at baseline (intervention group) vs after 1 year (control group).
Main Outcomes and Measures
The primary outcome was the 1-year change in LDL-C level. The secondary outcomes were 1-year concordance with American College of Cardiology-American Heart Association and Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for statin therapy and statin-associated muscle symptoms (SAMS).
Results
Among 408 patients (mean [SD] age, 64.1 [7.8] years; 25 women [6.1%]), 193 were randomized to the intervention group and 215 were randomized to the control group. Overall, 120 participants (29%) had a SLCO1B1 genotype indicating increased simvastatin myopathy risk. Physicians offered statin therapy to 65 participants (33.7%) in the intervention group and 69 participants (32.1%) in the control group. Compared with patients whose physicians did not know their SLCO1B1 results at baseline, patients whose physicians received the results had noninferior reductions in LDL-C at 12 months (mean [SE] change in LDL-C, -1.1 [1.2] mg/dL in the intervention group and -2.2 [1.3] mg/dL in the control group; difference, -1.1 mg/dL; 90% CI, -4.1 to 1.8 mg/dL; P < .001 for noninferiority margin of 10 mg/dL). The proportion of patients with American College of Cardiology-American Heart Association guideline-concordant statin prescriptions in the intervention group was noninferior to that in the control group (12 patients [6.2%] vs 14 patients [6.5%]; difference, -0.003; 90% CI, -0.038 to 0.032; P < .001 for noninferiority margin of 15%). All patients in both groups were concordant with CPIC guidelines for safe statin prescribing. Physicians documented 2 and 3 cases of SAMS in the intervention and control groups, respectively, none of which was associated with a CPIC guideline-discordant prescription. Among patients with a decreased or poor SLCO1B1 transporter function genotype, simvastatin was prescribed to 1 patient in the control group but none in the intervention group.
Conclusions and Relevance
Clinical testing and reporting of SLCO1B1 results for statin myopathy risk did not result in poorer ASCVD prevention in a routine primary care setting and may have been associated with physicians avoiding simvastatin prescriptions for patients at genetic risk for SAMS. Such an absence of harm should reassure stakeholders contemplating the clinical use of available pharmacogenetic results.
Trial Registration
ClinicalTrials.gov Identifier: NCT02871934.",2020,The solute carrier organic anion transporter family member 1B1 (SLCO1B1) genotype is associated with simvastatin myopathy risk and is proposed for clinical implementation.,"['December 2015 to July 2019 at 8 primary care practices in the Veterans Affairs Boston Healthcare System', 'Participants included statin-naive patients with elevated ASCVD risk', '408 patients (mean [SD] age, 64.1 [7.8] years; 25 women [6.1']",['simvastatin'],"['simvastatin myopathy risk', '1-year change in LDL-C level', 'Blood Cholesterol', '1-year concordance with American College of Cardiology-American Heart Association and Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for statin therapy and statin-associated muscle symptoms (SAMS', 'atherosclerotic cardiovascular disease (ASCVD) prevention']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031325', 'cui_str': 'Pharmacogenetics'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",,0.0818599,The solute carrier organic anion transporter family member 1B1 (SLCO1B1) genotype is associated with simvastatin myopathy risk and is proposed for clinical implementation.,"[{'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Vassy', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Green', 'Affiliation': 'Department of Medicine, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Ferguson', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Advani', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Miller', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Sojeong', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'Massachusetts College of Pharmacy and Health Sciences, Boston.'}, {'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Hage', 'Affiliation': 'Massachusetts College of Pharmacy and Health Sciences, Boston.'}, {'ForeName': 'Soo-Ji', 'Initials': 'SJ', 'LastName': 'Seo', 'Affiliation': 'Massachusetts College of Pharmacy and Health Sciences, Boston.'}, {'ForeName': 'Nilla', 'Initials': 'N', 'LastName': 'Majahalme', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'MacMullen', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Zimolzak', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Brunette', 'Affiliation': 'VA Boston Healthcare System, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.27092']
2382,33270115,Effects of Obesity And Insulin on Tissue-Specific Recycling Between Cortisol And Cortisone in Men.,"CONTEXT
11β-Hydroxysteroid dehydrogenase 1 (11βHSD1) reduces inert cortisone into active cortisol but also catalyzes reverse dehydrogenase activity. Drivers of cortisol/cortisone equilibrium are unclear. With obesity, 11βHSD1 transcripts are more abundant in adipose, but consequences for oxidation versus reduction remain unknown.
OBJECTIVE
Determine whether 11βHSD1 equilibrium in metabolic tissues is regulated by insulin and obesity.
DESIGN
Two-phase randomized crossover single-blinded study.
SETTING
Clinical Research Facility.
PARTICIPANTS
Ten lean and obese healthy men.
MAIN OUTCOME MEASURE(S)
11β-Reductase and 11β-dehydrogenase activities were measured during infusion of 9,11,12,12-[ 2H]4-cortisol and 1,2-[ 2H]2-cortisone, respectively, on two occasions, once during saline infusion and once during a hyperinsulinemic-euglycemic clamp. Arterialized and venous samples were obtained across forearm skeletal muscle and abdominal subcutaneous adipose. Steroids were quantified by liquid chromatography tandem mass spectrometry and adipose tissue transcripts by qPCR.
RESULTS
Neither whole-body nor tissue-specific rates of production of cortisol or cortisone differed between lean and obese men, however insulin attenuated the diurnal decrease. Whole body 11β-HSD1 reductase activity tended to be higher in obesity (~10%) and was further increased by insulin. Across adipose tissue, 11β-reductase activity was detected in obese individuals only and increased in the presence of insulin (18.99±9.62 vs placebo 11.68±3.63 pmol/100g; p<0.05). Across skeletal muscle, 11β-dehydrogenase activity was reduced by insulin in lean men only (2.55±0.90 vs 4.50±1.42 pmol/100g, p<0.05).
CONCLUSIONS
Regeneration of cortisol is up-regulated by insulin in adipose tissue but not skeletal muscle. In obesity, the equilibrium between 11β-reductase and 11β-dehydrogenase activities likely promotes cortisol accumulation in adipose, which may lead to adverse metabolic consequences.",2020,Whole body 11β-HSD1 reductase activity tended to be higher in obesity (~10%) and was further increased by insulin.,"['Men', 'lean men only (2.55±0.90', 'Ten lean and obese healthy men']",['Obesity And Insulin'],"['11β-Reductase and 11β-dehydrogenase activities', 'tissue-specific rates of production of cortisol or cortisone', 'Tissue-Specific Recycling', 'skeletal muscle, 11β-dehydrogenase activity', 'adipose tissue, 11β-reductase activity']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",10.0,0.0442352,Whole body 11β-HSD1 reductase activity tended to be higher in obesity (~10%) and was further increased by insulin.,"[{'ForeName': 'Anna J', 'Initials': 'AJ', 'LastName': 'Anderson', 'Affiliation': ""University/ BHF Centre for Cardiovascular Science, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Andrew', 'Affiliation': ""University/ BHF Centre for Cardiovascular Science, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Homer', 'Affiliation': ""Mass Spectrometry Core Laboratory, Edinburgh Clinical Research Facility, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hughes', 'Affiliation': ""University/ BHF Centre for Cardiovascular Science, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Luke D', 'Initials': 'LD', 'LastName': 'Boyle', 'Affiliation': ""University/ BHF Centre for Cardiovascular Science, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nixon', 'Affiliation': ""University/ BHF Centre for Cardiovascular Science, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Karpe', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Churchill Hospital, University of Oxford, Headington, Oxford, England, UK.'}, {'ForeName': 'Roland H', 'Initials': 'RH', 'LastName': 'Stimson', 'Affiliation': ""University/ BHF Centre for Cardiovascular Science, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, United Kingdom.""}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Walker', 'Affiliation': ""University/ BHF Centre for Cardiovascular Science, Queen's Medical Research Institute, Little France Crescent, University of Edinburgh, Edinburgh, United Kingdom.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa896']
2383,33270098,Efficacy of Capecitabine Plus Irinotecan vs Irinotecan Monotherapy as Second-line Treatment in Patients With Advanced Gallbladder Cancer: A Multicenter Phase 2 Randomized Clinical Trial (GB-SELECT).,"Importance
There is therapeutic uncertainty regarding use of combination or single-agent chemotherapy in the treatment of patients with gallbladder cancer who experience disease progression after first-line chemotherapy.
Objective
To compare the efficacy of capecitabine plus irinotecan (CAPIRI) vs irinotecan (IRI) alone in patients with advanced gallbladder cancer (GBC) who have disease progression after gemcitabine-based first-line treatment.
Design, Setting, and Participants
The GB-SELECT trial was a multicenter, open-label, phase 2, randomized clinical trial of CAPIRI vs IRI alone for treatment of gallbladder cancer in patients who had disease progression after prior gemcitabine-based chemotherapy.The study was carried out in 2 tertiary care institutions in India. Patients aged between 18 and 70 years with histopathologic diagnosis of adenocarcinoma gallbladder, advanced or metastatic disease, previous treatment with gemcitabine-based chemotherapy, adequate hematologic, liver, and renal functions, and ECOG performance status of 1 or less were included in the study between August 2018 and January 2020. The data were analyzed for this report with cutoff on May 19, 2020.
Interventions
Patients were randomized 1:1 to receive capecitabine, 1700 mg/m2 per day, on days 1 to 14 plus intravenous irinotecan, 200 mg/m2, on day 1 or intravenous irinotecan, 240 mg/m2, on day 1, in 21-day cycles until disease progression or unacceptable toxic effects.
Main Outcomes and Measures
The primary end point was overall survival (OS) at 6 months. The secondary end points were progression-free survival and quality of life.
Results
A total of 98 patients were randomized, 49 in each arm, with median (range) age of 51 (29-70) years, with 60 (61%) being women. In the CAPIRI vs IRI arms, the number of deaths at 6 months, 6-month OS, and median OS were 35, 34, 38.4% (95% CI, 24.2%-52.6%) and 5.16 (95% CI, 4.26-6.06) months vs 34, 29, 54.2% (95% CI, 39.4%-69.0%) and 6.28 (95% CI, 4.25-8.30) months, respectively, with a hazard ratio of 1.02 (95% CI, 0.64-1.49, P = .93). There were no chemotherapy-related deaths but more patients required dose modification in CAPIRI compared with the IRI arm (13 [27%] vs 4 [9%], respectively, P = .03).
Conclusions and Relevance
There was no significant difference in OS between treatment with capecitabine plus irinotecan or irinotecan alone among previously treated patients with gallbladder cancer. Single-agent irinotecan should be the preferred treatment option for such patients.
Trial Registration
CTRI/2017/10/010112.",2020,There was no significant difference in OS between treatment with capecitabine plus irinotecan or irinotecan alone among previously treated patients with gallbladder cancer.,"['patients who had disease progression after prior gemcitabine-based chemotherapy', 'patients with advanced gallbladder cancer (GBC) who have disease progression after gemcitabine-based first-line treatment', 'Patients aged between 18 and 70 years with histopathologic diagnosis of adenocarcinoma gallbladder, advanced or metastatic disease, previous treatment with gemcitabine-based chemotherapy, adequate hematologic, liver, and renal functions, and ECOG performance status of 1 or less were included in the study between August 2018 and January 2020', 'patients with gallbladder cancer', '98 patients were randomized, 49 in each arm, with median (range) age of 51 (29-70) years, with 60 (61%) being women', 'patients with gallbladder cancer who experience disease progression after first-line chemotherapy', 'Patients With Advanced Gallbladder Cancer', '2 tertiary care institutions in India']","['combination or single-agent chemotherapy', 'CAPIRI vs IRI alone', 'capecitabine plus irinotecan (CAPIRI) vs irinotecan (IRI) alone', 'irinotecan', 'Single-agent irinotecan', 'capecitabine', 'capecitabine plus irinotecan', 'Capecitabine Plus Irinotecan vs Irinotecan Monotherapy']","['6-month OS, and median OS', 'overall survival (OS', 'OS', 'progression-free survival and quality of life', 'number of deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0153452', 'cui_str': 'Malignant tumor of gallbladder'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677043', 'cui_str': 'Histopathology'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",98.0,0.189046,There was no significant difference in OS between treatment with capecitabine plus irinotecan or irinotecan alone among previously treated patients with gallbladder cancer.,"[{'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Ramaswamy', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Ostwal', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Medical Oncology, Dr B.R.A Institute-Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Prabhat', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sujay', 'Initials': 'S', 'LastName': 'Srinivas', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Goel', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Shraddha', 'Initials': 'S', 'LastName': 'Patkar', 'Affiliation': 'Department of Surgical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sarika', 'Initials': 'S', 'LastName': 'Mandavkar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Jadhav', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Parulekar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amitkumar', 'Initials': 'A', 'LastName': 'Choudhari', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, India.'}]",JAMA oncology,['10.1001/jamaoncol.2020.6166']
2384,33270032,Patient Interaction Phenotypes With an Automated Remote Hypertension Monitoring Program and Their Association With Blood Pressure Control: Observational Study.,"BACKGROUND
Automated texting platforms have emerged as a tool to facilitate communication between patients and health care providers with variable effects on achieving target blood pressure (BP). Understanding differences in the way patients interact with these communication platforms can inform their use and design for hypertension management.
OBJECTIVE
Our primary aim was to explore the unique phenotypes of patient interactions with an automated text messaging platform for BP monitoring. Our secondary aim was to estimate associations between interaction phenotypes and BP control.
METHODS
This study was a secondary analysis of data from a randomized controlled trial for adults with poorly controlled hypertension. A total of 201 patients with established primary care were assigned to the automated texting platform; messages exchanged throughout the 4-month program were analyzed. We used the k-means clustering algorithm to characterize two different interaction phenotypes: program conformity and engagement style. First, we identified unique clusters signifying differences in program conformity based on the frequency over time of error alerts, which were generated to patients when they deviated from the requested text message format (eg, ###/## for BP). Second, we explored overall engagement styles, defined by error alerts and responsiveness to text prompts, unprompted messages, and word count averages. Finally, we applied the chi-square test to identify associations between each interaction phenotype and achieving the target BP.
RESULTS
We observed 3 categories of program conformity based on their frequency of error alerts: those who immediately and consistently submitted texts without system errors (perfect users, 51/201), those who did so after an initial learning period (adaptive users, 66/201), and those who consistently submitted messages generating errors to the platform (nonadaptive users, 38/201). Next, we observed 3 categories of engagement style: the enthusiast, who tended to submit unprompted messages with high word counts (17/155); the student, who inconsistently engaged (35/155); and the minimalist, who engaged only when prompted (103/155). Of all 6 phenotypes, we observed a statistically significant association between patients demonstrating the minimalist communication style (high adherence, few unprompted messages, limited information sharing) and achieving target BP (P<.001).
CONCLUSIONS
We identified unique interaction phenotypes among patients engaging with an automated text message platform for remote BP monitoring. Only the minimalist communication style was associated with achieving target BP. Identifying and understanding interaction phenotypes may be useful for tailoring future automated texting interactions and designing future interventions to achieve better BP control.",2020,"We observed 3 categories of program conformity based on their frequency of error alerts: those who immediately and consistently submitted texts without system errors (perfect users, 51/201), those who did so after an initial learning period (adaptive users, 66/201), and those who consistently submitted messages generating errors to the platform (nonadaptive users, 38/201).","['adults with poorly controlled hypertension', 'patients engaging with an automated text message platform for remote BP monitoring', '201 patients with established primary care', 'system errors (perfect users, 51/201), those who did so after an initial learning period (adaptive users, 66/201), and those who consistently submitted messages generating errors to the platform (nonadaptive users, 38/201']",[],"['overall engagement styles, defined by error alerts and responsiveness to text prompts, unprompted messages, and word count averages', 'blood pressure (BP', 'achieving target BP']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",201.0,0.044875,"We observed 3 categories of program conformity based on their frequency of error alerts: those who immediately and consistently submitted texts without system errors (perfect users, 51/201), those who did so after an initial learning period (adaptive users, 66/201), and those who consistently submitted messages generating errors to the platform (nonadaptive users, 38/201).","[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Davoudi', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Natalie S', 'Initials': 'NS', 'LastName': 'Lee', 'Affiliation': 'National Clinician Scholars Program, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Chivers', 'Affiliation': 'Penn Medicine Predictive Healthcare, University of Pennsylvania Health System, Philadelphia, PA, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Delaney', 'Affiliation': 'Center for Healthcare Innovation, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Asch', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Center for Healthcare Innovation, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Center for Healthcare Innovation, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Krisda H', 'Initials': 'KH', 'LastName': 'Chaiyachati', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, United States.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Mowery', 'Affiliation': 'Department of Biostatistics, Epidemiology & Informatics, University of Pennsylvania, Philadelphia, PA, United States.'}]",Journal of medical Internet research,['10.2196/22493']
2385,33270028,Evaluation of a Serious Video Game to Facilitate Conversations About Human Papillomavirus Vaccination for Preteens: Pilot Randomized Controlled Trial.,"BACKGROUND
In the United States, the most common sexually transmitted infection, human papillomavirus (HPV), causes genital warts and is associated with an estimated 33,700 newly diagnosed cancer cases annually. HPV vaccination, especially for preteens aged 11 to 12 years, is effective in preventing the acquisition of HPV and HPV-associated cancers. However, as of 2018, completion of the 2- or 3-dose HPV vaccination series increased only from 48.6% to 51.1% in teens aged 13 to 17 years, and this increase was observed only in boys. By comparison, 88.7% of teens had more than one dose of the recommended vaccine against tetanus, diphtheria, and acellular pertussis (Tdap), and 85.1% of teens had more than one dose of meningococcal vaccine. Immunizations for Tdap, meningococcal disease, and HPV can occur at the same clinical visit but often do not.
OBJECTIVE
Vaccination against HPV is recommended for routine use in those aged 11 to 12 years in the United States, yet it is underutilized. We aimed to develop an educational video game to engage preteens in the decision to vaccinate.
METHODS
Land of Secret Gardens is a metaphor for protecting seedlings (body) with a potion (vaccine). We screened 131 dyads of parents and preteens from 18 primary practices in North Carolina who had not initiated HPV vaccination. We measured vaccination intentions, story immersion, and game play and documented HPV vaccination rates. A total of 55 dyads were enrolled, and we randomly assigned 28 (21 completed) to play the game and 27 (26 completed) to the comparison group.
RESULTS
In total, 18 preteens reported playing the game. The vaccination self-efficacy score was higher in the comparison group than the intervention group (1.65 vs 1.45; P=.05). The overall mean decisional balance score trended toward greater support of vaccination, although differences between the groups were not significant.. Vaccine initiation and completion rates were higher in the intervention group (22% vs 15%; P=.31) than in the comparison group (9% vs 2%; P=.10), although the difference was not significant.
CONCLUSIONS
Video games help preteens in the decision to pursue HPV vaccination. A serious video game on HPV vaccination is acceptable to parents and preteens and can be played as intended. Gamification is effective in increasing preteen interest in HPV vaccination, as game features support decision making for HPV vaccination.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04627298; https://www.clinicaltrials.gov/ct2/show/NCT04627298.",2020,"Vaccine initiation and completion rates were higher in the intervention group (22% vs 15%; P=.31) than in the comparison group (9% vs 2%; P=.10), although the difference was not significant.
","['preteens aged 11 to 12 years', 'Land of Secret Gardens is a metaphor for protecting seedlings (body) with a potion (vaccine', 'Preteens', '131 dyads of parents and preteens from 18 primary practices in North Carolina who had not initiated HPV vaccination', 'A total of 55 dyads were enrolled, and we randomly assigned 28 (21 completed) to play the game and 27 (26 completed) to the comparison group', '33,700 newly diagnosed cancer cases annually']","['educational video game', 'Serious Video Game to Facilitate Conversations']","['overall mean decisional balance score', 'vaccination self-efficacy score', '2- or 3-dose HPV vaccination series', 'Vaccine initiation and completion rates', 'vaccination intentions, story immersion, and game play and documented HPV vaccination rates']","[{'cui': 'C1444711', 'cui_str': 'Pre-teen'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0868963', 'cui_str': 'Gardening'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0302829', 'cui_str': 'Metaphor'}, {'cui': 'C0242437', 'cui_str': 'Seedling'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332181', 'cui_str': 'Annual'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]",55.0,0.161691,"Vaccine initiation and completion rates were higher in the intervention group (22% vs 15%; P=.31) than in the comparison group (9% vs 2%; P=.10), although the difference was not significant.
","[{'ForeName': 'Joan R', 'Initials': 'JR', 'LastName': 'Cates', 'Affiliation': 'UNC Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Bernard F', 'Initials': 'BF', 'LastName': 'Fuemmeler', 'Affiliation': 'Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, United States.'}, {'ForeName': 'Laurie L', 'Initials': 'LL', 'LastName': 'Stockton', 'Affiliation': 'UNC Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Diehl', 'Affiliation': 'UNC Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Crandell', 'Affiliation': 'UNC Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Tamera', 'Initials': 'T', 'LastName': 'Coyne-Beasley', 'Affiliation': ""Department of Pediatrics, Children's of Alabama, University of Alabama, Birmingham, AL, United States.""}]",JMIR serious games,['10.2196/16883']
2386,33270026,Effectiveness of WeChat for Improving Exclusive Breastfeeding in Huzhu County China: Randomized Controlled Trial.,"BACKGROUND
The benefits of breastfeeding for both infants and mothers have been well recognized. However, the exclusive breastfeeding rate in China is low and decreasing. Mobile technologies have rapidly developed; communication apps such as WeChat (one of the largest social networking platforms in China) are widely used and have the potential to conveniently improve health behaviors.
OBJECTIVE
This study aimed to assess the effectiveness of using WeChat to improve breastfeeding practices.
METHODS
This 2-arm randomized controlled trial was conducted among pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China. Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet. A total of 344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group. Women in the intervention group received breastfeeding knowledge and promotion information weekly through a WeChat official account from their third month of pregnancy to 6 months postpartum. The primary outcome of exclusive and predominant breastfeeding rate was measured 0-1 month, 2-3 months, and 4-5 months postpartum.
RESULTS
At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001). Similarly, mothers in the intervention group were more likely to provide predominantly breast milk (OR 2.77, 95% CI 1.55-4.96; P<.001) and less likely to give dairy products to their children (OR 0.40, 95% CI 0.21-0.75; P=.005). There was no statistically significant difference for exclusive breastfeeding rate 2-3 months (P=.09) and 4-5 months postpartum (P=.27), though more children in the intervention group were exclusively breastfed than those in the control group 2-3 months postpartum (intervention: 111/152, 73.0%; control: 96/152, 63.2%) and 4-5 months postpartum(intervention: 50/108, 46.3%; control: 46/109, 42.2%).
CONCLUSIONS
This study is the first effort to promote exclusive breastfeeding through WeChat in China, which proved to be an effective method of promoting exclusive breastfeeding in early life. WeChat health education can be used in addition to local breastfeeding promotion programs.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1800017364; http://www.chictr.org.cn/showproj.aspx?proj=29325.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1186/s12889-019-7676-2.",2020,"At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001).","['344 pregnant women were recruited at baseline, with 170 in the intervention group and 174 in the control group', 'Huzhu County China', 'Pregnant women were eligible to participate if they were aged 18 years or older, were 11 to 37 weeks pregnant with a singleton fetus, had no known illness that could limit breastfeeding after childbirth, used WeChat through their smartphone, and had access to the internet', 'pregnant women from May 2019 to April 2020 in Huzhu County, Qinghai Province, China']","['WeChat', 'breastfeeding knowledge and promotion information weekly through a WeChat official account']","['exclusive and predominant breastfeeding rate', 'likely to provide predominantly breast milk', 'exclusive breastfeeding rate']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0460089', 'cui_str': 'Finding of length of gestation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0517671', 'cui_str': 'Knowledge level: breastfeeding'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}]",344.0,0.129367,"At 0-1 month postpartum, the exclusive breastfeeding rate was significantly higher in the intervention group than that in the control group (81.1% vs 63.3%; odds ratio [OR] 2.75, 95% CI 1.58-4.78; P<.001).","[{'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Yiwen', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Zijun', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Michelle Helena', 'Initials': 'MH', 'LastName': 'van Velthoven', 'Affiliation': 'University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Capital Institute of Pediatrics, Beijing, China.'}, {'ForeName': 'Yanfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Capital Institute of Pediatrics, Beijing, China.'}]",Journal of medical Internet research,['10.2196/23273']
2387,33053113,Effects of the prophylactic use of escitalopram on the prognosis and the plasma copeptin level in patients with acute cerebral infarction.,"This study aimed to investigate whether the routine administration of escitalopram for three months would improve the prognosis of patients with ischemic stroke and decrease the plasma copeptin level. A total of 97 patients with acute cerebral infarction were randomly allocated to receive escitalopram (5-10 mg once per day, orally; n=49) or not to receive escitalopram (control group; n=48) for 12 weeks starting at 2-7 days after the onset of stroke. Both groups received conventional treatments, including physiotherapy and secondary prevention of stroke. The National Institutes of Health Stroke Scale (NIHSS) score was used to evaluate the disability of patients at the initial evaluation and at the monthly follow-up visits for three months. Impairment in the daily activities was assessed using the Barthel Index (BI), while cognitive impairment was assessed using Mini-Mental State Examination (MMSE) score. The psychiatric assessment included the administration of the Present State Examination modified to identify Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of depression. The severity of depression was measured using the 17-item Hamilton Rating Scale for Depression (HAMD). During the 3-month follow-up period, 95 patients were included in the analysis (two patients withdrew from the escitalopram group). NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01). In patients with acute ischemic stroke, the earlier administration of escitalopram for three months may improve neurological functional prognosis and decrease copeptin level.",2020,"NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01).","['97 patients with acute cerebral infarction', 'patients with ischemic stroke', 'patients with acute cerebral infarction', 'patients with acute ischemic stroke']","['escitalopram (5-10 mg once per day, orally; n=49) or not to receive escitalopram', 'escitalopram']","['Barthel Index (BI), while cognitive impairment was assessed using Mini-Mental State Examination (MMSE) score', 'Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) symptoms of depression', 'severity of depression', 'neurological functional prognosis and decrease copeptin level', 'Health Stroke Scale (NIHSS) score', 'NIHSS and BI improvement', '17-item Hamilton Rating Scale for Depression (HAMD', 'plasma copeptin level', 'HAMD and plasma copeptin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0007785', 'cui_str': 'Cerebral infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",97.0,0.0563996,"NIHSS and BI improvement at the 90th day were significantly greater in the escitalopram group (P<0.05), while HAMD and plasma copeptin levels significantly decreased, compared to the control group (P<0.01).","[{'ForeName': 'Jin-Xia', 'Initials': 'JX', 'LastName': 'Cao', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yun-Tao', 'Initials': 'YT', 'LastName': 'Sun', 'Affiliation': ""Department of Neuropsychiatry, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Qing-Hong', 'Initials': 'QH', 'LastName': 'Zeng', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Laboratory, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}, {'ForeName': 'Jie-Chun', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, The Second People's Hospital of Lianyungang, Lianyungang, Jiangsu, China.""}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20208930']
2388,33053116,A novel stem cell therapy for hepatitis B virus-related acute-on-chronic liver failure.,"The aim of this study was to propose a stem cell therapy for hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) based on plasma exchange (PE) for peripheral blood stem cell (PBSC) collection and examine its safety and efficacy. Sixty patients (n=20 in each group) were randomized to PE (PE alone), granulocyte colony-stimulating factor (G-CSF) (PE after G-CSF treatment), and PBSC transplantation (PBSCT) (G-CSF, PE, PBSC collection and hepatic artery injection) groups. Patients were followed-up for 24 weeks. Liver function and adverse events were recorded. Survival analysis was performed. PBSCT improved blood ammonia levels at 1 week (P<0.05). The level of total bilirubin, international normalized ratio, and creatinine showed significant differences in the 4th week of treatment (P<0.05). The survival rates of the PE, G-CSF, and PBSCT groups were 50, 65, and 85% at 90 days (P=0.034). There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021). The preliminary results suggested that PBSCT was safe, with a possibility of improved 90-day survival in patients with HBV-ACLF.",2020,There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021).,"['patients with HBV-ACLF', 'Sixty patients (n=20 in each group', 'hepatitis B virus-related acute-on-chronic liver failure', 'hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF']","['PE (PE alone), granulocyte colony-stimulating factor (G-CSF) (PE after G-CSF treatment), and PBSC transplantation (PBSCT', 'PBSCT']","['survival rates', 'blood ammonia levels', 'Liver function and adverse events', '90-day survival', 'level of total bilirubin, international normalized ratio, and creatinine']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C3850141', 'cui_str': 'Acute on chronic liver failure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242602', 'cui_str': 'Peripheral blood stem cell graft'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0428437', 'cui_str': 'Blood ammonia measurement'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",,0.070712,There was a significant difference in 90-day survival between the PE and PBSCT groups (P=0.021).,"[{'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}, {'ForeName': 'Shaoli', 'Initials': 'S', 'LastName': 'You', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Rong', 'Affiliation': 'Department of Infection and Liver Diseases, Peking University International Hospital, Beijing, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Therapy, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Sa', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Fangjiao', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hongling', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Liver Transplantation Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Huaming', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Interventional Therapy, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Dongze', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Wanshu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Liver Failure Treatment and Research Center, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Xin', 'Affiliation': 'Medical School of Chinese PLA, Beijing, China.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20209728']
2389,33058835,Exogenous testosterone decreases men's sensitivity to vocal cues of male dominance.,"Assessing dominance is important for effective social interactions, and prior research suggests that testosterone is associated with men's dominance perceptions. The present study tested for a causal effect of exogenous testosterone on men's sensitivity to vocal cues of other men's dominance, an important parameter in male-male competition across species. One hundred and thirty-nine Chinese men received a single dose (150 mg) of testosterone or placebo gel in a double-blind, placebo-controlled, between-participant design. Participants reported their own dominance and judged other men's dominance from voices. Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group. Moreover, men's dominance sensitivity was negatively associated with their self-reported dominance in our Chinese sample, consistent with findings from Western populations. These results indicate that exogenous testosterone has a causal effect in decreasing men's dominance sensitivity, consistent with the Challenge Hypothesis, suggesting that the fluctuation of testosterone concentration mediates individuals' behaviors. Additionally, the present study could motivate further work on vocal assessment in the context of competition in humans and other species.",2020,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"['One hundred and thirty-nine Chinese men', ""men's sensitivity to vocal cues of other men's dominance""]","['testosterone or placebo gel', 'Exogenous testosterone', 'testosterone', 'exogenous testosterone', 'placebo']","[""Men's dominance sensitivity""]","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205101', 'cui_str': 'External'}]","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",139.0,0.161778,Men's dominance sensitivity was significantly weaker in the testosterone group compared to those in the placebo group.,"[{'ForeName': 'Chengyang', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Watkins', 'Affiliation': 'Division of Psychology, School of Applied Sciences, Abertay University, Dundee, United Kingdom.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Nan', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'School of Business Administration, Zhejiang University of Finance and Economics, Hangzhou, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Psychology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104871']
2390,33065228,Short and long-term effects of water-based aerobic and concurrent training on cardiorespiratory capacity and strength of older women.,"Studies show that, in the short term, water-based aerobic training (WAT) promotes the same strength gains as water-based concurrent training (WCT). In addition, it is known that some training progression strategy must be employed after the first weeks of training in order to continue stimulating neuromuscular gains. The aim of this paper was to compare the effects of three water-based training on cardiorespiratory capacity and strength of older women in short and long-terms. Fifty-seven participants were randomized into the groups: 1) aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS). Participants trained twice a week for 16 weeks. An incremental treadmill test and the one-repetition maximal test of knee extensors were performed before and after 8 and 16 weeks. Peak oxygen consumption showed similar increases from pre to post-16 weeks (AT: 9%, CTRE: 11%, CTMS: 5%). Oxygen consumption at the second ventilatory threshold and strength were increased from pre to post-8 weeks (AT: 15%, CTRE: 16%, CTMS: 3% and AT: 9%, CTRE: 5%, CTMS: 9%, respectively) and from post-8 to post-16 weeks (AT: 6%, CTRE: 3%, CTMS: 12% and AT: 4%, CTRE: 8%, CTMS: 4%, respectively). In conclusion, the three training programs promoted similar increases in the cardiorespiratory capacity and WAT promoted similar strength gains as WCT in short and long terms. Moreover, the use of resistive equipment and the increase in the number of sets are effective progression strategies.",2020,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"['older women', 'Fifty-seven participants', 'older women in short and long-terms']","['aerobic training (AT); 2) concurrent training whose resistance training progressed to the use of resistive equipment (CTRE); and 3) concurrent training whose resistance training progressed to multiple sets (CTMS', 'CTMS', 'three water-based training', 'water-based aerobic and concurrent training', 'water-based aerobic training (WAT']","['cardiorespiratory capacity and strength', 'Peak oxygen consumption', 'Oxygen consumption', 'strength gains']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0661732', 'cui_str': 'cyclohexane-1,2,4-tris(methylenesulfonate)'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",57.0,0.0184618,Peak oxygen consumption showed similar increases from pre to post-16 weeks,"[{'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Reichert', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: thais_reichert@hotmail.com.'}, {'ForeName': 'Rochelle Rocha', 'Initials': 'RR', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Artur Avelino Birk', 'Initials': 'AAB', 'LastName': 'Preissler', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Henrique Bianchi', 'Initials': 'HB', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Cláudia Gomes', 'Initials': 'CG', 'LastName': 'Bracht', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna Machado', 'Initials': 'BM', 'LastName': 'Barroso', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vitória', 'Initials': 'V', 'LastName': 'de Mello Bones da Rocha', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Andressa Freitas', 'Initials': 'AF', 'LastName': 'Correia', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Luiz Fernando Martins', 'Initials': 'LFM', 'LastName': 'Kruel', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111103']
2391,33065275,Vitamin D and survival in COVID-19 patients: A quasi-experimental study.,"Vitamin D may be a central biological determinant of COVID-19 outcomes. The objective of this quasi-experimental study was to determine whether bolus vitamin D3 supplementation taken during or just before COVID-19 was effective in improving survival among frail elderly nursing-home residents with COVID-19. Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study. The ""Intervention group"" was defined as those having received bolus vitamin D3 supplementation during COVID-19 or in the preceding month, and the ""Comparator group"" corresponded to all other participants. The primary and secondary outcomes were COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score in acute phase, respectively. Age, gender, number of drugs daily taken, functional abilities, albuminemia, use of corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin), and hospitalization for COVID-19 were used as potential confounders. The Intervention (n = 57; mean ± SD, 87.7 ± 9.3years; 79 %women) and Comparator (n = 9; mean, 87.4 ± 7.2years; 67 %women) groups were comparable at baseline, as were the COVID-19 severity and the use of dedicated COVID-19 drugs. The mean follow-up time was 36 ± 17 days. 82.5 % of participants in the Intervention group survived COVID-19, compared to only 44.4 % in the Comparator group (P = 0.023). The full-adjusted hazard ratio for mortality according to vitamin D3 supplementation was HR = 0.11 [95 %CI:0.03;0.48], P = 0.003. Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002). Finally, vitamin D3 supplementation was inversely associated with OSCI score for COVID-19 (β=-3.84 [95 %CI:-6.07;-1.62], P = 0.001). In conclusion, bolus vitamin D3 supplementation during or just before COVID-19 was associated in frail elderly with less severe COVID-19 and better survival rate.",2020,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"['frail elderly nursing-home residents with COVID-19', 'COVID-19 patients', 'Sixty-six residents with COVID-19 from a French nursing-home were included in this quasi-experimental study']","['corticosteroids and/or hydroxychloroquine and/or antibiotics (i.e., azithromycin or rovamycin', 'vitamin D3 supplementation', 'Vitamin D', 'bolus vitamin D3 supplementation']","['longer survival time', 'COVID-19 mortality and Ordinal Scale for Clinical Improvement (OSCI) score', 'survival rate', 'survival', 'Vitamin D and survival', 'OSCI score']","[{'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0878223', 'cui_str': 'Rovamycin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",66.0,0.0876815,Kaplan-Meier distributions showed that Intervention group had longer survival time than Comparator group (log-rank P = 0.002).,"[{'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Annweiler', 'Affiliation': 'Department of Geriatric Medicine and Memory Clinic, Research Center on Autonomy and Longevity, University Hospital, Angers, France; UPRES EA 4638, University of Angers, Angers, France; Robarts Research Institute, Department of Medical Biophysics, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, ON, Canada. Electronic address: Cedric.Annweiler@chu-angers.fr.'}, {'ForeName': 'Bérangère', 'Initials': 'B', 'LastName': 'Hanotte', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': ""Grandin de l'Eprevier"", 'Affiliation': 'Geriatric Hospital of Saint Laurent de Chamousset, Saint Laurent de Chamousset, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Sabatier', 'Affiliation': 'Université Aix-Marseille, Institut de Neuro-Physiopathologie (INP), UMR 7051, Faculté de Pharmacie, 27 Bd Jean Moulin, 13385, Marseille Cedex, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Lafaie', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Célarier', 'Affiliation': 'Department of Clinical Gerontology, University Hospital of Saint-Etienne, Saint-Etienne, France; Chaire Santé des Ainés, University of Jean Monnet, Saint-Etienne, France; Gérontopôle Auvergne-Rhône-Alpes, Saint-Etienne, France.'}]",The Journal of steroid biochemistry and molecular biology,['10.1016/j.jsbmb.2020.105771']
2392,33263170,Oral high-dose sucrosomial iron vs intravenous iron in sideropenic anemia patients intolerant/refractory to iron sulfate: a multicentric randomized study.,"Iron deficiency anemia is among the most frequent causes of disability. Intravenous iron is the quickest way to correct iron deficiency, bypassing the bottleneck of iron intestinal absorption, the only true mechanism of iron balance regulation in human body. Intravenous iron administration is suggested in patients who are refractory/intolerant to oral iron sulfate. However, the intravenous way of iron administration requires several precautions; as the in-hospital administration requires a resuscitation service, as imposed in Europe by the European Medicine Agency, it is very expensive and negatively affects patient's perceived quality of life. A new oral iron formulation, Sucrosomial iron, bypassing the normal way of absorption, seems to be cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations. In this multicentric randomized study, we analyze the cost-effectiveness of intravenous sodium ferrigluconate vs oral Sucrosomial iron in patients with iron deficiency anemia refractory/intolerant to oral iron sulfate without other interfering factors on iron absorption.",2020,"A new oral iron formulation, Sucrosomial iron, bypassing the normal way of absorption, seems to be cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations.","['patients with iron deficiency anemia refractory/intolerant to oral iron sulfate without other interfering factors on iron absorption', 'sideropenic anemia patients intolerant/refractory to iron sulfate', 'patients who are refractory/intolerant to oral iron sulfate']","['Oral high-dose sucrosomial iron vs intravenous iron', 'intravenous sodium ferrigluconate vs oral Sucrosomial iron']",['cost-effectiveness'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0142871', 'cui_str': 'sodium iron(III)gluconate'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0652317,"A new oral iron formulation, Sucrosomial iron, bypassing the normal way of absorption, seems to be cost-effective in correcting iron deficiency anemia at doses higher than those usually effective with other oral iron formulations.","[{'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Giordano', 'Affiliation': 'Division of Internal Medicine, Hematology Service, Regional Hospital ""A. Cardarelli"", Campobasso, Italy.'}, {'ForeName': 'Mariasanta', 'Initials': 'M', 'LastName': 'Napolitano', 'Affiliation': 'Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), Haematology Unit, University Hospital ""P. Giaccone"", University of Palermo, Via del Vespro 127, 90127, Palermo, Italy. mariasanta.napolitano@unipa.it.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Di Battista', 'Affiliation': 'Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Lucchesi', 'Affiliation': 'Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}]",Annals of hematology,['10.1007/s00277-020-04361-3']
2393,33263056,Azithromycin for sarcoidosis cough: an open-label exploratory clinical trial.,"Background
Chronic cough is a distressing symptom for many people with pulmonary sarcoidosis. Continuous treatment with a macrolide antibiotic may improve cough. We aimed to assess the potential efficacy of azithromycin in patients with sarcoidosis and self-reported cough.
Methods
We conducted a noncontrolled, open-label clinical trial of azithromycin 250 mg once daily for 3 months in patients with pulmonary sarcoidosis who reported a chronic cough. The primary outcome was number of coughs in 24 h. Secondary outcomes were cough visual analogue scales and quality of life measured using the Leicester Cough Questionnaire and King's Sarcoidosis Questionnaire. Safety outcomes included QTc interval on ECG. Measurements were made at baseline and after 1 and 3 months of treatment.
Results
All 21 patients were white, median age 57 years, 9 males, 12 females, median 3 years since diagnosis. Five were taking oral corticosteroids and none were taking other immunosuppressants. Twenty patients completed the trial. The median (range) number of coughs in 24 h was 228 (43-1950) at baseline, 122 (20-704) at 1 month, and 81 (16-414) at 3 months (p=0.002, Friedman's test). The median reduction in cough count at 3 months was 49.6%. There were improvements in all patient-reported outcomes. Azithromycin was well tolerated.
Conclusion
In a noncontrolled open-label trial in people with sarcoidosis who reported a chronic cough, 3 months of treatment with azithromycin led to improvements in a range of cough metrics. Azithromycin should be tested as a treatment for sarcoidosis cough in a randomised placebo-controlled trial.",2020,There were improvements in all patient-reported outcomes.,"['Twenty patients completed the trial', 'patients with pulmonary sarcoidosis who reported a chronic cough', 'many people with pulmonary sarcoidosis', 'sarcoidosis cough', 'patients with sarcoidosis and self-reported cough', 'people with sarcoidosis who reported a chronic cough, 3\u2005months of treatment with', 'All 21 patients were white, median age 57', 'years, 9 males, 12 females, median 3 years since diagnosis']","['macrolide antibiotic', 'Azithromycin', 'azithromycin']","['median (range) number of coughs', ""cough visual analogue scales and quality of life measured using the Leicester Cough Questionnaire and King's Sarcoidosis Questionnaire"", 'tolerated', 'range of cough metrics', 'cough', 'median reduction in cough count', 'QTc interval on ECG', 'number of coughs in 24\u2005h']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036205', 'cui_str': 'Pulmonary sarcoidosis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010201', 'cui_str': 'Chronic cough'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036202', 'cui_str': 'Sarcoidosis'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",21.0,0.181243,There were improvements in all patient-reported outcomes.,"[{'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Fraser', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Thackray-Nocera', 'Affiliation': 'Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Shepherd', 'Affiliation': 'Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Flockton', 'Affiliation': 'Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wright', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Sheedy', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Kayleigh', 'Initials': 'K', 'LastName': 'Brindle', 'Affiliation': 'Respiratory Clinical Trials Unit, Hull University Teaching Hospitals NHS Trust, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Alyn H', 'Initials': 'AH', 'LastName': 'Morice', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Kaye', 'Affiliation': 'York Biomedical Research Institute, University of York, York, UK.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Crooks', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Hart', 'Affiliation': 'Respiratory Research Group, Hull York Medical School, Castle Hill Hospital, Cottingham, UK.'}]",ERJ open research,['10.1183/23120541.00534-2020']
2394,33263055,Comparison of ciliary beat frequencies at different temperatures in young adults.,"Rationale
Direct visualisation of ciliary beat pattern (CBP) and ciliary beat frequency (CBF) has been recommended as the first-line diagnostic test in patients suspected of having primary ciliary dyskinesia (PCD). However, the test procedure is not yet completely standardised, and centres measure the CBF at different temperatures.
Objectives
It was the aim of the study to compare CBF at different temperatures, to establish normative values, to check for age dependency and to measure the temperature on the nasal mucosa of the participants.
Methods
High-speed video-microscopy analysis with a Sisson-Ammons Video Analysis (SAVA) system was used to determine CBP and CBF in the participants.
Measurements
Nasal brushings were taken and CBF was measured in randomised order at three temperatures: 25°C, 32°C and 37°C.
Main results
In total, 100 healthy young adults (74 female, 26 male), aged 20.2-31.9 years, were included in the study. We found a highly significant difference among the groups: the median CBF was 7.0 Hz at 25°C, 7.6 Hz at 32°C and 8.0 Hz at 37°C. The maximum time period ex vivo was 65 min and did not differ significantly. However, CBF was significantly higher when the cilia were kept at a higher temperature before the measurements were made. We found no correlation between CBF and the age of the participants. The median nasal mucosal temperature in our study participants was 30.2°C (range 24.7-35.8°C) comparable to the 30.2-34.4°C described in the literature.
Conclusions
The most appropriate temperature at which to measure CBF is 32°C. In our study, with 95% confidence for this temperature the CBF was between 6.3 and 9.0 Hz.",2020,The maximum time period ex vivo was 65 min and did not differ significantly.,"['100 healthy young adults (74 female, 26 male), aged 20.2-31.9 years, were included in the study', 'patients suspected of having primary ciliary dyskinesia (PCD', 'young adults']",['Rationale\n\n\nDirect visualisation of ciliary beat pattern (CBP) and ciliary beat frequency (CBF'],"['maximum time period ex vivo', 'CBF', 'median CBF', 'median nasal mucosal temperature']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0522483', 'cui_str': 'Patient suspected of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}]","[{'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}]",100.0,0.0413205,The maximum time period ex vivo was 65 min and did not differ significantly.,"[{'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Nikolaizik', 'Affiliation': ""Dept of Pediatric Chest Medicine, Children's Hospital, Philipps-University Marburg, Marburg, Germany.""}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hahn', 'Affiliation': ""Dept of Pediatric Chest Medicine, Children's Hospital, Philipps-University Marburg, Marburg, Germany.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Bauck', 'Affiliation': ""Dept of Pediatric Chest Medicine, Children's Hospital, Philipps-University Marburg, Marburg, Germany.""}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': ""Dept of Pediatric Chest Medicine, Children's Hospital, Philipps-University Marburg, Marburg, Germany.""}]",ERJ open research,['10.1183/23120541.00477-2020']
2395,33263052,"Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial.","Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD. We explored the impact of myCOPD in patients with mild-moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score. Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV 1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, -1.27 (95% CI -4.47-1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09-1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46-5.85) in favour of myCOPD. The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.",2020,The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30,"['individuals with more severe COPD', 'patients with mild-moderate or recently diagnosed COPD', 'patients with mild, moderate and newly diagnosed COPD', 'Sixty patients were randomised (29 myCOPD, 31 usual care']",['myCOPD'],"['mean COPD assessment test (CAT) score', 'odds of ≥1 critical inhaler error', 'CAT score improvement', 'exacerbation frequency and CAT score', 'app usage and patient activation measurement (PAM) score', 'CAT score']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",60.0,0.221658,The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30,"[{'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Crooks', 'Affiliation': 'Hull York Medical School, Hull, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Elkes', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Storrar', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust - Basingstoke Hospital, Basingstoke, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Roy', 'Affiliation': 'West Hertfordshire Hospital NHS Trust - Hemel Hempstead Hospital, Hemel Hempstead, UK.'}, {'ForeName': 'Mal', 'Initials': 'M', 'LastName': 'North', 'Affiliation': 'mymhealth Limited, Bournemouth, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blythin', 'Affiliation': 'mymhealth Limited, Bournemouth, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Watson', 'Affiliation': 'University of Southampton Faculty of Medicine, Southampton, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Cornelius', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Tom M A', 'Initials': 'TMA', 'LastName': 'Wilkinson', 'Affiliation': 'mymhealth Limited, Bournemouth, UK.'}]",ERJ open research,['10.1183/23120541.00460-2020']
2396,33262569,Corneal Endothelial Cell Changes After Phacoemulsification Combined with Excisional Goniotomy with the Kahook Dual Blade or iStent: A Prospective Fellow-Eye Comparison.,"Purpose
To characterize changes in endothelial cell density and morphology following phacoemulsification combined with either excisional goniotomy with the Kahook Dual Blade (KDB-phaco) or first-generation iStent trabecular microbypass implantation (iStent-phaco).
Setting
A single clinical practice.
Methods
Twenty-one adult subjects from one center with visually significant cataract and mild-moderate open-angle glaucoma underwent KDB-phaco or iStent-phaco in one eye and the alternate procedure in the fellow eye as part of a prospective, multicenter, randomized trial. Specular microscopy and pachymetry were performed before and 6-29 months after surgery. Parameters analyzed included change from baseline of endothelial cell density (ECD), the coefficient of variation (CV), the percent of hexagonal cells (%HEX), and central corneal thickness (CCT).
Results
Baseline ECD, CV, %HEX, and CCT were similar between groups. A mean (standard deviation) of 18.2 (5.8) months postoperatively (range 12.5-28.7 months), the change from baseline in ECD was -90 ± 226 cells/mm 2 (-3.4%) in KDB-phaco eyes (p=0.083) and -239 ± 247 cells/mm 2 (-9.0%) in iStent-phaco eyes (p<0.001); the change in iStent-phaco eyes was significantly greater than in KDB-phaco eyes (p=0.013). The magnitude of Endothelial Cell Loss (ECL) was not correlated with length of postoperative follow-up time in either group. No significant differences in change from baseline in CV, %HEX, or CCT were noted with the exception of a decrease in %HEX in iStent-phaco eyes (p=0.017). No eyes manifested corneal edema, decompensation, or other cornea-related complications.
Conclusion
Both KDB-phaco and iStent-phaco are associated with postoperative ECL, with iStent-phaco producing significantly greater ECL than KDB-phaco. The clinical significance of these findings is unclear, and future studies are warranted to more robustly characterize long-term effects of glaucoma surgical procedures-with and without permanent implants-on ECD and corneal health and to develop evidence-based guidelines for the pre- and post-operative evaluation of corneal health in eyes undergoing glaucoma surgery.",2020,The magnitude of Endothelial Cell Loss (ECL) was not correlated with length of postoperative follow-up time in either group.,"['Methods\n\n\nTwenty-one adult subjects from one center with visually significant cataract and mild-moderate open-angle glaucoma underwent', 'eyes undergoing glaucoma surgery']","['KDB-phaco or iStent-phaco in one eye and the alternate procedure', 'phacoemulsification combined with either excisional goniotomy with the Kahook Dual Blade (KDB-phaco) or first-generation iStent trabecular microbypass implantation (iStent-phaco', 'Phacoemulsification Combined with Excisional Goniotomy with the Kahook Dual Blade or iStent']","['endothelial cell density (ECD), the coefficient of variation (CV), the percent of hexagonal cells (%HEX), and central corneal thickness (CCT', 'Endothelial Cell Loss (ECL', 'endothelial cell density and morphology', 'Corneal Endothelial Cell Changes', 'CV, %HEX, or CCT', 'corneal edema, decompensation, or other cornea-related complications', 'Results\n\n\nBaseline ECD, CV, %HEX, and CCT']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",21.0,0.101447,The magnitude of Endothelial Cell Loss (ECL) was not correlated with length of postoperative follow-up time in either group.,"[{'ForeName': 'Syril', 'Initials': 'S', 'LastName': 'Dorairaj', 'Affiliation': 'Department of Ophthalmology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Goundappa K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S263072']
2397,33262435,Consistency of hemodynamic and autonomic mechanisms underlying post-exercise hypotension.,"Post-exercise hypotension (PEH) is a clinically relevant phenomenon, but its mechanisms vary between different studies and between the participants within each study. Additionally, it is possible that PEH mechanisms are not consistent in each individual (i.e. within-individual variation), which has not been investigated yet. Thus, the aim of the current study was to assess the within-individual consistency of PEH hemodynamic and autonomic mechanisms. For that, 30 subjects performed 4 sessions divided in 2 blocks (test and retest). In each block, an exercise (cycling, 45 min, 50%VO 2 peak) and a control (seated rest, 45 min) session was randomly conducted. Blood pressure (BP) and its mechanisms were evaluated pre- and post-interventions. In each block, individual responses were calculated as post-exercise minus post-control, and a response was considered present when its magnitude reached the typical error of the measurement. Consistencies were evaluated by comparing test and retest responses through kappa coefficient (k). PEH consistency was calculated using role sample, while mechanisms consistency was evaluated in those with consistent PEH. Twenty-one (70%) participants showed consistent PEH, 5 (17%) presented PEH in only test or retest and 4 (13%) had absent PEH response, characterising a good consistency (k = 0.510). Regarding mechanisms' responses, good consistency was found for heart rate (k = 0.456), sympathovagal balance (k = 0.438), and baroreflex sensitivity (k = 0.458); while systemic vascular resistance (k = 0.152), cardiac output (k = -0.400), stroke volume (k = -0.055), and sympathetic vasomotor modulation (k = -0.096) presented marginal consistencies. Thus, PEH is a highly consistent physiological phenomenon, although its mechanisms present variable consistencies.",2020,"Regarding mechanisms' responses, good consistency was found for heart rate (k = 0.456), sympathovagal balance (k = 0.438), and baroreflex sensitivity (k = 0.458); while systemic vascular resistance (k = 0.152), cardiac output (k = -0.400), stroke volume (k = -0.055), and sympathetic vasomotor modulation (k = -0.096) presented marginal consistencies.",[],['Post-exercise hypotension (PEH'],"['cardiac output', 'stroke volume', 'heart rate', 'absent PEH response', 'Blood pressure (BP', 'systemic vascular resistance', 'sympathetic vasomotor modulation', 'baroreflex sensitivity', 'sympathovagal balance', 'PEH consistency']",[],"[{'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",,0.049415,"Regarding mechanisms' responses, good consistency was found for heart rate (k = 0.456), sympathovagal balance (k = 0.438), and baroreflex sensitivity (k = 0.458); while systemic vascular resistance (k = 0.152), cardiac output (k = -0.400), stroke volume (k = -0.055), and sympathetic vasomotor modulation (k = -0.096) presented marginal consistencies.","[{'ForeName': 'Rafael Yokoyama', 'Initials': 'RY', 'LastName': 'Fecchio', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Brito', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Peçanha', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cláudia Lúcia de Moraes', 'Initials': 'CLM', 'LastName': 'Forjaz', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil. cforjaz@usp.br.'}]",Journal of human hypertension,['10.1038/s41371-020-00452-w']
2398,33262414,Feasibility of a transmucosal sublingual fentanyl tablet as a procedural pain treatment in colonoscopy patients: a prospective placebo-controlled randomized study.,"Since patients often experience pain and unpleasantness during a colonoscopy, the present study aimed to evaluate the efficacy and safety of sublingually administered fentanyl tablets for pain treatment. Furthermore, since the use of intravenous drugs significantly increases colonoscopy costs, sublingual tablets could be a cost-effective alternative to intravenous sedation. We conducted a prospective placebo-controlled randomized study of 158 patients to evaluate the analgesic effect of a 100 µg dose of sublingual fentanyl administered before a colonoscopy. Pain, sedation, nausea, and satisfaction were assessed during the colonoscopy by the patients as well as the endoscopists and nurses. Respiratory rate and peripheral arteriolar oxygen saturation were monitored throughout the procedure. There were no differences between the fentanyl and placebo groups in any of the measured variables. The median pain intensity values, as measured using a numerical rating scale, were 4.5 in the fentanyl group and 5 in the placebo group. The sedation and oxygen saturation levels and the respiratory rate did not differ between the groups. The majority of the colonoscopies were completed.Our results indicate that a 100 µg dose of sublingual fentanyl is not beneficial compared to the placebo in the treatment of procedural pain during a colonoscopy.",2020,"The median pain intensity values, as measured using a numerical rating scale, were 4.5 in the fentanyl group and 5 in the placebo group.","['colonoscopy patients', '158 patients']","['sublingual fentanyl', 'transmucosal sublingual fentanyl tablet', 'placebo']","['median pain intensity values', 'procedural pain', 'Respiratory rate and peripheral arteriolar oxygen saturation', 'numerical rating scale', 'Pain, sedation, nausea, and satisfaction', 'efficacy and safety', 'analgesic effect', 'sedation and oxygen saturation levels and the respiratory rate']","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1513727', 'cui_str': 'Transmucosal route'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1619712', 'cui_str': 'Procedural pain'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",158.0,0.0517055,"The median pain intensity values, as measured using a numerical rating scale, were 4.5 in the fentanyl group and 5 in the placebo group.","[{'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Fihlman', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Turku, Kiinamyllynkatu 4-8, P.O. Box 52, 20520, Turku, Finland. mari.fihlman@tyks.fi.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Karru', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Turku, Kiinamyllynkatu 4-8, P.O. Box 52, 20520, Turku, Finland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Varpe', 'Affiliation': 'Department of Digestive Surgery, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Huhtinen', 'Affiliation': 'Department of Digestive Surgery, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hagelberg', 'Affiliation': 'Pain Clinic, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Saari', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, University of Turku, Kiinamyllynkatu 4-8, P.O. Box 52, 20520, Turku, Finland.'}, {'ForeName': 'K T', 'Initials': 'KT', 'LastName': 'Olkkola', 'Affiliation': 'Department of Anaesthesiology, Intensive Care, and Pain Medicine, University of Helsinki and HUS Helsinki University Hospital, Helsinki, Finland.'}]",Scientific reports,['10.1038/s41598-020-78002-0']
2399,33262411,Epinephrine minimizes the use of bipolar coagulation and preserves ovarian reserve in laparoscopic ovarian cystectomy: a randomized controlled trial.,"We propose a novel method, the epinephrine compression method (Epi-pledget), as a hemostasis method for ovarian cystectomy. A total of 179 patients undergoing laparoscopic ovarian cystectomy with stripping were randomly allocated into three groups: the bipolar coagulation group, the Epi-pledget group, and the coagulation after Epi-pledget (Epi & Coagulation) group. Serum anti-Müllerian hormone (AMH) levels and antral follicle count (AFC) by ultrasonography were measured to determine the preservation of ovarian function. To evaluate the postoperative ovarian cellular proliferative activity and tissue damage in a mouse model, we operated on the ovaries of mice with an artificial incision injury and applied two hemostatic methods: coagulation and Epi-pledget. Eight weeks after surgery, the AMH rate significantly decreased in the bipolar coagulation group compared with the Epi-pledget group. The AFC decline rate was also significantly greater in the coagulation group than the Epi-pledget group. Specifically, patients with endometrioma had a significantly greater decline of serum AMH in the coagulation group than the Epi-pledget group. In a histopathological analysis in mice, the Epi-pledget group showed ameliorated fibrotic changes and necrotic findings in the injured lesion compared with the bipolar coagulation group. The Epi-pledget method for ovarian stripping has an additional benefit of maximizing the preservation of the ovarian reserve, especially for the endometriotic ovarian cyst type.",2020,"Eight weeks after surgery, the AMH rate significantly decreased in the bipolar coagulation group compared with the Epi-pledget group.","['179 patients undergoing laparoscopic ovarian cystectomy with stripping', 'laparoscopic ovarian cystectomy']","['epinephrine compression method (Epi-pledget', 'artificial incision injury and applied two hemostatic methods: coagulation and Epi-pledget', 'Epinephrine', 'bipolar coagulation group, the Epi-pledget group, and the coagulation after Epi-pledget (Epi & Coagulation']","['serum AMH', 'AMH rate', 'Serum anti-Müllerian hormone (AMH) levels and antral follicle count (AFC', 'AFC decline rate', 'fibrotic changes and necrotic findings']","[{'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4521311', 'cui_str': 'Pledget'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",179.0,0.0722652,"Eight weeks after surgery, the AMH rate significantly decreased in the bipolar coagulation group compared with the Epi-pledget group.","[{'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Park', 'Affiliation': 'Department of Obstetrics and Gynecology, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwondo, 26426, Republic of Korea.'}, {'ForeName': 'Kyu-Hee', 'Initials': 'KH', 'LastName': 'Hwang', 'Affiliation': 'Department of Physiology, Department of Global Medical ScienceMitohormesis Research Center, Institute of Mitochondrial Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwondo, 26426, Republic of Korea.'}, {'ForeName': 'Ji-Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Physiology, Department of Global Medical ScienceMitohormesis Research Center, Institute of Mitochondrial Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwondo, 26426, Republic of Korea.'}, {'ForeName': 'San-Hui', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwondo, 26426, Republic of Korea.'}, {'ForeName': 'Kyu-Sang', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Physiology, Department of Global Medical ScienceMitohormesis Research Center, Institute of Mitochondrial Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwondo, 26426, Republic of Korea.'}, {'ForeName': 'Seong Jin', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Department of Obstetrics and Gynecology, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwondo, 26426, Republic of Korea. choisj@yonsei.ac.kr.'}, {'ForeName': 'Seung-Kuy', 'Initials': 'SK', 'LastName': 'Cha', 'Affiliation': 'Department of Physiology, Department of Global Medical ScienceMitohormesis Research Center, Institute of Mitochondrial Medicine, Yonsei University Wonju College of Medicine, 20 Ilsan-ro, Wonju, Gangwondo, 26426, Republic of Korea. skcha@yonsei.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-77781-w']
2400,33262194,Randomised controlled trial of tailored support to increase physical activity and reduce smoking in smokers not immediately ready to quit: protocol for the Trial of physical Activity-assisted Reduction of Smoking (TARS) Study.,"INTRODUCTION
Smoking reduction can lead to increased success in quitting. This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit. This paper reports the study design and methods.
METHODS AND ANALYSIS
A pragmatic, multicentred, parallel, two group, randomised controlled superiority clinical trial, with embedded process evaluation and economics evaluation. Participants who wished to reduce smoking with no immediate plans to quit were randomised 1:1 to receive either (1) tailored individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control). Participants in both arms of the trial were also signposted to usual local support for smoking reduction and quitting. The primary outcome measure is 6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire at 3 and 9 months post-baseline. Participants confirmed as abstinent at 9 months will be followed up at 15 months.
ETHICS AND DISSEMINATION
Approved by SW Bristol National Health Service Research Committee (17/SW/0223). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will be disseminated to trial participants and healthcare providers.
TRIAL REGISTRATION NUMBER
ISRCTN47776579; Pre-results.",2020,"This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit.","['smokers not immediately ready to quit', 'Participants who wished to reduce smoking with no immediate plans to quit']","['physical Activity-assisted Reduction of Smoking (TARS', 'client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA', 'individual health trainer face-to-face and/or telephone support to reduce smoking and increase PA as an aid to smoking reduction (intervention) or (2) brief written/electronic advice to reduce or quit smoking (control']","['6-month carbon monoxide-confirmed floating prolonged abstinence following participant self-reported quitting on a mailed questionnaire', 'physical activity']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0039315', 'cui_str': 'Tar'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.102951,"This study aims to determine if a client-focused motivational support package for smoking reduction (and quitting) and increasing (or otherwise using) physical activity (PA) can help smokers who do not wish to quit immediately to reduce the amount they smoke, and ultimately quit.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK adrian.taylor@plymouth.ac.uk.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Thompson', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Division of Population Health Sciences and Education, University of London, St George's, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Division of Public Health and Primary Health Care, Oxford, UK.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': ""Division of Population Health Sciences and Education, University of London, St George's, London, UK.""}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Adam Justin', 'Initials': 'AJ', 'LastName': 'Streeter', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Chynoweth', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Ingram', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Science, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hancocks', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Snowsill', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Callaghan', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Price', 'Affiliation': 'Sport and Health Sciences, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Horrell', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'King', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gude', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'George', 'Affiliation': ""Division of Population Health Sciences and Education, University of London, St George's, London, UK.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Wahlich', 'Affiliation': ""Division of Population Health Sciences and Education, University of London, St George's, London, UK.""}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Hamilton', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Division of Public Health and Primary Health Care, Oxford, UK.'}, {'ForeName': 'Kelisha', 'Initials': 'K', 'LastName': 'Cheema', 'Affiliation': 'School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campbell', 'Affiliation': 'School of Medicine, Faculty of Health, University of Plymouth, Plymouth, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Preece', 'Affiliation': 'Public Health, Plymouth City Council, Windsor House, Plymouth, Devon, UK.'}]",BMJ open,['10.1136/bmjopen-2020-043331']
2401,33262195,Creatine kinase during non-ST-segment elevation acute coronary syndromes is associated with major bleeding.,"BACKGROUND
It was recently reported that highly elevated plasma activity of the ADP-scavenging enzyme creatine kinase (CK), to >10 times the upper reference limit (URL), is independently associated with fatal or non-fatal bleeding during treatment for ST-segment elevation myocardial infarction (OR 2.6 (95% CI, 1.8 to 2.7)/log CK increase). Evidence indicates that CK attenuates ADP-dependent platelet aggregation. This study investigates whether moderately elevated CK in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) is associated with major bleeding.
METHODS
The Thrombolysis In Myocardial Ischemia (TIMI) 3B trial compared recombinant tissue-type plasminogen activator (rt-PA) (35-80 mg) with placebo and early catheterisation with conservative management in patients with NSTE-ACS. Main outcomes of the current study are the independent association of peak plasma CK (CKmax) with adjudicated fatal or non-fatal major bleeding (primary) and with combined major bleeding, stroke and hospital death (secondary), with covariables including age, sex, body mass index, systolic blood pressure, creatinine and assignment to add-on rt-PA versus placebo. Discrimination was assessed with C-statistics.
RESULTS
The study included 1473 patients (66% men, 80% white, mean age 59 years, SE 0.3). CKmax ranged between 15 and 19 045 IU/L (mean (SE), 450 (24) IU/L; two times URL). Major bleeding occurred in 2.0% (mean age 65 (1.3) years; mean CKmax 1015 (319) IU/L; six times URL), and the combined outcome in 4.3% of the patients, adjusted OR per log CK increase, respectively, 3.1 (1.6 to 5.9) for major bleeding and 3.9 (2.5 to 6.1) for the combined outcome; C-index 0.8 for both outcomes. The association between CK and bleeding was independent of the use of thrombolytic therapy.
DISCUSSION
The presented data add to the existing evidence that proportionate to its plasma activity, the ADP-binding enzyme CK is strongly and independently associated with non-fatal and fatal major bleeding during treatment for NSTE-ACS. CK might increase the accuracy of prediction models for major bleeding in patients with NSTE-ACS.
TRIAL REGISTRATION NUMBER
NCT00000472.",2020,"Major bleeding occurred in 2.0% (mean age 65 (1.3) years; mean CKmax 1015 (319) IU/L; six times URL), and the combined outcome in 4.3% of the patients, adjusted OR per log CK increase, respectively, 3.1 (1.6 to 5.9) for major bleeding and 3.9 (2.5 to 6.1) for the combined outcome; C-index 0.8 for both outcomes.","['1473 patients (66% men, 80% white, mean age 59 years, SE 0.3', 'patients with NSTE-ACS']","['recombinant tissue-type plasminogen activator (rt-PA', 'placebo and early catheterisation with conservative management', 'CK']","['peak plasma CK (CKmax) with adjudicated fatal or non-fatal major bleeding (primary) and with combined major bleeding, stroke and hospital death (secondary), with covariables including age, sex, body mass index, systolic blood pressure, creatinine and assignment to add-on rt-PA versus placebo', 'major bleeding', 'Major bleeding', 'CK and bleeding', 'Myocardial Ischemia (TIMI', 'Creatine kinase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0858114', 'cui_str': 'Plasma creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0277608', 'cui_str': 'Death in hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]",1473.0,0.0610064,"Major bleeding occurred in 2.0% (mean age 65 (1.3) years; mean CKmax 1015 (319) IU/L; six times URL), and the combined outcome in 4.3% of the patients, adjusted OR per log CK increase, respectively, 3.1 (1.6 to 5.9) for major bleeding and 3.9 (2.5 to 6.1) for the combined outcome; C-index 0.8 for both outcomes.","[{'ForeName': 'Lizzy Maritza', 'Initials': 'LM', 'LastName': 'Brewster', 'Affiliation': 'Department of Cardiovascular Disease, CK Science Foundation, Amsterdam, The Netherlands mail@lizzybrewster.net.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Fernand', 'Affiliation': 'Clinic for Health and Individual Medicine, Utrecht, Netherlands.'}]",Open heart,['10.1136/openhrt-2020-001281']
2402,33262189,"Simvastatin add-on to escitalopram in patients with comorbid obesity and major depression (SIMCODE): study protocol of a multicentre, randomised, double-blind, placebo-controlled trial.","INTRODUCTION
Major depressive disorder (MDD) and obesity are both common disorders associated with significant burden of disease worldwide. Importantly, MDD and obesity often co-occur, with each disorder increasing the risk for developing the other by about 50%-60%. Statins are among the most prescribed medications with well-established safety and efficacy. Statins are recommended in primary prevention of cardiovascular disease, which has been linked to both MDD and obesity. Moreover, statins are promising candidates to treat MDD because a meta-analysis of pilot randomised controlled trials has found antidepressive effects of statins as adjunct therapy to antidepressants. However, no study so far has tested the antidepressive potential of statins in patients with MDD and comorbid obesity. Importantly, this is a difficult-to-treat population that often exhibits a chronic course of MDD and is more likely to be treatment resistant. Thus, in this confirmatory randomised controlled trial, we will determine whether add-on simvastatin to standard antidepressant medication with escitalopram is more efficacious than add-on placebo over 12 weeks in 160 patients with MDD and comorbid obesity.
METHODS AND ANALYSIS
This is a protocol for a randomised, placebo-controlled, double-blind multicentre trial with parallel-group design (phase II). One hundred and sixty patients with MDD and comorbid obesity will be randomised 1:1 to simvastatin or placebo as add-on to standard antidepressant medication with escitalopram. The primary outcome is change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to week 12. Secondary outcomes include MADRS response (defined as 50% MADRS score reduction from baseline), MADRS remission (defined as MADRS score <10), mean change in patients' self-reported Beck Depression Inventory (BDI-II) and mean change in high-density lipoprotein, low-density lipoprotein and total cholesterol from baseline to week 12.
ETHICS AND DISSEMINATION
This protocol has been approved by the ethics committee of the federal state of Berlin (Ethik-Kommission des Landes Berlin, reference: 19/0226-EK 11) and by the relevant federal authority (Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), reference: 4043387). Study findings will be published in peer-reviewed journals and will be presented at (inter)national conferences.
TRIAL REGISTRATION NUMBERS
NCT04301271, DRKS00021119, EudraCT 2018-002947-27.",2020,"Importantly, MDD and obesity often co-occur, with each disorder increasing the risk for developing the other by about 50%-60%.","['One hundred and sixty patients with MDD and comorbid obesity', 'patients with MDD and comorbid obesity', '160 patients with MDD and comorbid obesity', 'patients with comorbid obesity and major depression (SIMCODE']","['simvastatin', 'simvastatin or placebo', 'placebo', 'Simvastatin']","['change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score', ""MADRS response (defined as 50% MADRS score reduction from baseline), MADRS remission (defined as MADRS score <10), mean change in patients' self-reported Beck Depression Inventory (BDI-II) and mean change in high-density lipoprotein, low-density lipoprotein and total cholesterol""]","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",160.0,0.720699,"Importantly, MDD and obesity often co-occur, with each disorder increasing the risk for developing the other by about 50%-60%.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany christian.otte@charite.de.'}, {'ForeName': 'Woo Ri', 'Initials': 'WR', 'LastName': 'Chae', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Nowacki', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kaczmarczyk', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Piber', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Märschenz', 'Affiliation': 'NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Lischewski', 'Affiliation': 'NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sein', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Clinical Research Unit, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Ettrich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Hans Joergen', 'Initials': 'HJ', 'LastName': 'Grabe', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Goethe University Frankfurt, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinkelmann', 'Affiliation': 'Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychosomatic Medicine, Center for Internal Medicine and Dermatology, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Janowitz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medicine Greifswald, Greifswald, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Junghanns', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kai G', 'Initials': 'KG', 'LastName': 'Kahl', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Tillmann H C', 'Initials': 'THC', 'LastName': 'Krueger', 'Affiliation': 'Department of Psychiatry, Social Psychiatry and Psychotherapy, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Leicht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Prvulovic', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Hospital of the Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Hospital of the Goethe University Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoettle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Westermair', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Gottingen, Germany.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Gold', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]",BMJ open,['10.1136/bmjopen-2020-040119']
2403,33262113,TRAINING-Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery): multicenter randomized study comparing neoadjuvant chemotherapy for patients managed for ovarian cancer with or without a connected pre-habilitation program.,"BACKGROUND
Patients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer may have impaired functional capacity, nutritional status, and emotional well-being.
PRIMARY OBJECTIVES
TRAINING-01 aims to determine if a connected pre-habilitation program during neoadjuvant chemotherapy for patients treated for an advanced ovarian cancer will improve physical capacity before major abdomino-pelvic surgery.
STUDY HYPOTHESIS
A pre-habilitation program during neoadjuvant chemotherapy will bring a fitter patient to surgery and will decrease treatment morbidity and improve oncological outcomes.
TRIAL DESIGN
This study is a prospective, multi-center, phase III study. The pre-habilitation program consists of providing multi-dimensional support during neoadjuvant chemotherapy using connected devices. The control group will receive usual care.
MAJOR INCLUSION/EXCLUSION CRITERIA
Eligible patients will be women with International Federation of Gynecology and Obstetrics stage III-IV advanced ovarian cancer undergoing neoadjuvant chemotherapy. Patients must be able to perform a cardiopulmonary exercise test.
PRIMARY ENDPOINTS
The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO 2 max) between baseline and surgery in the pre-habilitation group and control groups.
SAMPLE SIZE
136 patients (68 per arm) will be recruited to demonstrate a medium standardized effect d=0.5 in the variations of VO 2 max between baseline and surgery.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
The duration of the study includes 24 months of recruitment and 5 years of follow up. We anticipate reporting primary endpoint results in 2024.
TRIAL REGISTRATION
TRAINING-01-IPC 2018-039 (NCT04451369).",2020,"The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO 2 max) between baseline and surgery in the pre-habilitation group and control groups.
","['patients managed for ovarian cancer with or without a connected pre-habilitation program', '136 patients (68 per arm', 'Patients undergoing neoadjuvant chemotherapy before surgery for advanced ovarian cancer', 'patients treated for an advanced ovarian cancer', 'Eligible patients will be women with International Federation of Gynecology and Obstetrics stage III-IV advanced ovarian cancer undergoing neoadjuvant chemotherapy', 'Ovary 01 (connecTed pRehabiliAtIoN pelvIc caNcer surGery']","['usual care', 'neoadjuvant chemotherapy', 'connected pre-habilitation program during neoadjuvant chemotherapy']",['maximum oxygen uptake (VO 2 max'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018459', 'cui_str': 'Habilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0029939', 'cui_str': 'Ovarian structure'}, {'cui': 'C0751416', 'cui_str': 'Pelvic Cancer'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0018459', 'cui_str': 'Habilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.219128,"The primary endpoint will be the comparison of the variation in maximum oxygen uptake (VO 2 max) between baseline and surgery in the pre-habilitation group and control groups.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lambaudie', 'Affiliation': 'Department of Surgery, Institut Paoli-Calmettes, Marseille, France lambaudiee@ipc.unicancer.fr.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Bannier/Braticevic', 'Affiliation': 'Department of Oncology, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Charlène', 'Initials': 'C', 'LastName': 'Villaron/Goetgheluck', 'Affiliation': 'Management Sport and Cancer Laboratory EA4670, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Zemmour', 'Affiliation': 'Department of Clinical Research and Innovation, Statistics and Methodology Unit, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Boher', 'Affiliation': 'Department of Clinical Research and Innovation, Statistics and Methodology Unit, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ben Soussan', 'Affiliation': 'Department of Clinical Psychology, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Jihane', 'Initials': 'J', 'LastName': 'Pakradouni', 'Affiliation': 'Department of Clinical Research and Innovation, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Brun', 'Affiliation': 'Department of Anesthesiology, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Leonor', 'Initials': 'L', 'LastName': 'Lopez Almeida', 'Affiliation': 'Department of Clinical Research and Innovation, Paoli-Calmettes Institute, Marseille, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marino', 'Affiliation': 'Aix Marseille University, INSERM, IRD, SESSTIM, Marseille, France.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-002128']
2404,33262083,Artificial Neural Networks as a Way to Predict Future Kidney Cancer Incidence in the United States.,"INTRODUCTION
The incidence of kidney cancer is increasing; it could be counteracted with new ways to predict and detect it. We aimed to implement an artificial neural network in order to predict new cases of renal-cell carcinoma (RCC) in the population using population rate, obesity, smoking incidence, uncontrolled hypertension, and life expectancy data in the United States.
PATIENTS AND METHODS
Statistics were collected on US population numbers, life expectancy, obesity, smoking, and hypertension. We used MATLAB R2018 (MathWorks) software to implement an artificial neural network. Data were repeatedly and randomly divided into training (70%) and validation (30%) subsets.
RESULTS
The number of new RCC cases will grow from 44,400 (2020) to 55,400 (2050), an increase of +24.7%. Our data show that preventing hypertension would have the greatest impact on reduction of the incidence, estimated at -775 and -575 cases per year in 2020 and in 2030, respectively. The prevention of obesity and smoking would have a more limited impact, estimated at -64 and -180 cases per year in 2020 and in 2030, respectively, for obesity, and -173 and -21 cases per year in 2020 and in 2030, respectively, for smoking.
CONCLUSIONS
Our predictions underline the need for accurate studies on RCC-related risk factors to reduce the incidence.",2020,"The prevention of obesity and smoking would have a more limited impact, estimated at -64 and -180 cases per year in 2020 and in 2030, respectively, for obesity, and -173 and -21 cases per year in 2020 and in 2030, respectively, for smoking.
",[],[],"['Kidney Cancer Incidence', 'life expectancy, obesity, smoking, and hypertension']",[],[],"[{'cui': 'C0740457', 'cui_str': 'Malignant tumor of kidney'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",,0.0375046,"The prevention of obesity and smoking would have a more limited impact, estimated at -64 and -180 cases per year in 2020 and in 2030, respectively, for obesity, and -173 and -21 cases per year in 2020 and in 2030, respectively, for smoking.
","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Santoni', 'Affiliation': 'Oncology Unit, Macerata Hospital, Macerata, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Piva', 'Affiliation': 'Department of Specialistic Clinical and Odontostomatological Sciences, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Department of Biomedical Sciences and Human Oncology, University of Bari ""A. Moro,"" Bari, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Struttura Complessa di Oncologia Medica e Traslazionale, Azienda Ospedaliera Santa Maria di Terni, Terni, Italy.'}, {'ForeName': 'Daniel Y', 'Initials': 'DY', 'LastName': 'Heng', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Tom Baker Cancer Centre, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Matrana', 'Affiliation': 'Department of Internal Medicine, Hematology/Oncology, Ochsner Medical Center, New Orleans, LA.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Grande', 'Affiliation': 'Medical Oncology Department, MD Anderson Cancer Center, Madrid, Spain.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Mollica', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Aurilio', 'Affiliation': 'Medical Oncology Division of Urogenital and Head and Neck Tumours, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Mimma', 'Initials': 'M', 'LastName': 'Rizzo', 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia and Division of Translational Oncology, IRCCS Istituti Clinici Scientifici Maugeri, Pavia, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Giulietti', 'Affiliation': 'Department of Specialistic Clinical and Odontostomatological Sciences, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Montironi', 'Affiliation': 'Section of Pathological Anatomy, Polytechnic University of the Marche Region, School of Medicine, United Hospitals, Ancona, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Oncologia Medica, Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. Electronic address: fmassari79@gmail.com.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2020.10.008']
2405,33269848,[Strategy of acetabular anteversion in total hip arthroplasty with lumbar degenerative kyphosis].,"OBJECTIVE
To investigate how to place the anteversion of acetabular prosthesis more reasonably in patients with lumbar degenerative kyphosis.
METHODS
A total of 122 patients with degenerative kyphosis of lumbar spine who underwent total hip arthroplasty from December 2017 to October 2019 were included and divided into experimental group and control group, 61 cases in each group. In experimental group, there were 25 males and 36 females, with a median age of 67.0 years;the median course of disease was 46.0 months;the functional pelvic plane with acetabular anteversion was set according to different types of pelvic anterior plane bracket. In control group, there were 27 males and 34 females, with a median age of 67.0 years;the median course was 42.0 months;in control group, the anteversion was set by the traditional method. The patients were followed up for 3 months. The operation time and blood loss were recorded. The incidence of infection and dislocation within 3 months was counted. Harris score before and 3 months after operation was recorded. Functional anteversion angle of standing position was measured 3 months after operation.
RESULTS
Compared with control group, there was no difference in operation time and blood loss between the two groups (P=0.918, 0.381);there was no infection between two groups within 3 months after operation;there was 1 case of hip joint dislocation in the control group and no dislocation in experimental group. There was no significant difference in Harris score before and after operation. Three months later, reexamination of pelvic standing radiographs showed that the number of patients with functional anteversion of acetabular prosthesis outside the safe area was less in experimental group thanin control group ( P =0.048), and the functional anteversion angle of acetabular prosthesis was more concentrated in the range of 15 ° to 20 ° in experimental group ( P <0.001).
CONCLUSION
According to the preoperative evaluation and classification of patients, better functional anteversion of acetabular prosthesis can be obtained with the help of pelvic anterior plane reference bracket in hip arthroplasty with lumbar degenerative kyphosis.",2020,"Compared with control group, there was no difference in operation time and blood loss between the two groups (P=0.918, 0.381);there was no infection between two groups within 3 months after operation;there was 1 case of hip joint dislocation in the control group and no dislocation in experimental group.","['122 patients with degenerative kyphosis of lumbar spine who underwent total hip arthroplasty from December 2017 to October 2019', '27 males and 34 females, with a median age of 67.0 years;the median course was 42.0 months;in control group, the anteversion was set by the traditional method', 'patients with lumbar degenerative kyphosis', 'total hip arthroplasty with lumbar degenerative kyphosis', 'hip arthroplasty with lumbar degenerative kyphosis', '25 males and 36 females, with a median age of 67.0 years;the median course of disease was 46.0 months;the functional pelvic plane with acetabular anteversion was set according to different types of pelvic anterior plane bracket']",['acetabular anteversion'],"['functional anteversion of acetabular prosthesis outside the safe area', 'Harris score', 'Functional anteversion angle of standing position', 'hip joint dislocation', 'operation time and blood loss', 'incidence of infection and dislocation', 'functional anteversion angle of acetabular prosthesis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]","[{'cui': 'C0333053', 'cui_str': 'Anteversion'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0333053', 'cui_str': 'Anteversion'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0019554', 'cui_str': 'Dislocation of hip joint'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}]",122.0,0.0120254,"Compared with control group, there was no difference in operation time and blood loss between the two groups (P=0.918, 0.381);there was no infection between two groups within 3 months after operation;there was 1 case of hip joint dislocation in the control group and no dislocation in experimental group.","[{'ForeName': 'Hai-Zhao', 'Initials': 'HZ', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Shou-Li', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Zhong-Yi', 'Initials': 'ZY', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Pei-Jian', 'Initials': 'PJ', 'LastName': 'Tong', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Hong', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Fan', 'Affiliation': 'Department of Orthopaedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, Jiangsu, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.11.004']
2406,33269838,"[Therapeutic effects of ""kidney three-needle"" therapy plus fire needling therapy in treatment of post-stroke urinary incontinence].","OBJECTIVE
To observe the efficacy of ""kidney three-needle"" therapy[Qugu(CV2) and 1 cun to the left and right of CV2] and the pricking technique of fire needing therapy on urinary frequency and maximal bladder volume in potients with post-stroke urinary incontinence.
METHODS
A total of 60 patients with post-stroke urinary incontinence were collected according to the inclusion and exclusion criteria and were randomized into an observation group (30 cases) and a control group (30 cases). On the base of the routine medication and rehabilitation treatment, acupuncture was applied to the general acupoints for motor impairment and speech disorder in the two groups. Additionally, the combination of ""kidney three-needle"" therapy and the pricking technique of fire needling therapy was used for urinary incontinence in the observation group and the common acupuncture was applied in the control group. Needles were retained for 30 min and acupuncture was provided once daily, 5 days a weeks, 2 weeks of treatment as one course. Both groups were treated for 3 courses. Before and after treatment, the rank of daytime urinary frequency was compared in the patients of the two groups. Ultrasound B was adopted to determine the maximal bladder volume. The total effective rate was compared between the two groups.
RESULTS
After treatment, the rank of daytime urinary frequency all reduced significantly as compared with that before treatment in the patients of the two groups ( P <0.01), and the observation group was lower than the control group ( P <0.05). After the treatment, the maximal bladder volume increased significantly as compared with that before treatment in the self-comparison of each group ( P <0.01) and the volume in the observation group was significantly higher than that in the control group ( P <0.01). The total effective rate was 93.3% (28/30) in the observation group and was 66.7% (20/30) in the control group. The total effective rate in the observation group was higher obviously than that in the control group ( P <0.05).
CONCLUSION
The combination of ""kidney three-needle"" therapy and the pricking technique of fire needling therapy significantly reduces the rank of daytime urinary frequency and increases maximal bladder volume in the patients with post-stroke urinary incontinence. The therapeutic effect of such combined acupuncture treatment is better than the common acupuncture therapy.",2020,"The total effective rate in the observation group was higher obviously than that in the control group ( P <0.05).
","['potients with post-stroke urinary incontinence', 'patients with post-stroke urinary incontinence', '60 patients with post-stroke urinary incontinence', 'post-stroke urinary incontinence']","['kidney three-needle"" therapy plus fire needling therapy', 'acupuncture', 'kidney three-needle"" therapy and the pricking technique of fire needling therapy']","['total effective rate', 'daytime urinary frequency', 'rank of daytime urinary frequency', 'maximal bladder volume', 'urinary frequency and maximal bladder volume', 'urinary incontinence']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429770', 'cui_str': 'Bladder volume'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}]",60.0,0.0161408,"The total effective rate in the observation group was higher obviously than that in the control group ( P <0.05).
","[{'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Deng', 'Affiliation': ""Department of Acupuncture of Traditional Chinese Medicine, Pingxiang People's Hospital, Pingxiang 337000, Jiangxi Province, China.""}, {'ForeName': 'Jiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Acupuncture of Traditional Chinese Medicine, Pingxiang People's Hospital, Pingxiang 337000, Jiangxi Province, China.""}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.200395']
2407,33269837,[Transcutaneous electrical acupoint stimulation relieves post-operative nausea and vomiting possibly by reducing serum motilin secretion in patients undergoing laparoscopic surgery].,"OBJECTIVE
To observe the effect of transcutaneous electrical acupoint stimulation (TEAS) of different acupoint combinations on postoperative nausea and vomiting (PONV) and serum motilin (MTL) content in patients undergoing laparoscopic surgery, so as to provide evidence for clinical selection of suitable acupoint compatibility.
METHODS
A total of 140 patients undergoing elective laparoscopic surgery were randomly divided into general anesthesia (GA) control, TG 2 [Neiguan (PC6) + Hegu (LI4)], TG 3 [PC6 + LI4 + Zusanli (ST36)], and TG 4 [PC6 + LI4 + ST36 + Sanyinjiao (SP6)] groups, with 35 cases in each group. Patients of the TG 2 , TG 3 and TG 4 groups received TEAS (2 Hz/100 Hz, 3-8 mA) of the above mentioned acupoint (bilateral) groups for 30 min before the induction of anesthesia until the end of the operation. Patients of the GA control group received intravenous injection of Midazolam, Sufentanil, Propofol, Rocuronium Bromide, etc. The blood sample (4 mL) from the right median cubital vein was collected at the time of patient's entry, 12 and 24 h after surgery, respectively, for measuring MTL concentration by enzyme-linked immunosorbent assay. The incidence of early and late PONV and changes of PONV degree within 24 h after surgery were recorded.
RESULTS
The serum MTL concentrations were significantly decreased at 12 h after surgery in all the 4 groups ( P <0.05), and decreased at 24 h after surgery in GA and TG2 groups vs their own pre-surgery (P < 0.05), and considerably higher at both 12 and 24 h after surgery in the TG 2 , TG 3 and TG 4 groups than in the GA control group ( P <0.05), and also evidently higher in the TG 3 and TG 4 groups than in the TG 2 group ( P <0.05). The incidence of PONV was significantly lower in the TG 2 , TG 3 and TG 4 groups than in the GA control group in the early and late periods (except TG 2 group) of surgery ( P <0.05). The number of patients with PONV grade Ⅰ was significantly larger in the TG 2 , TG 3 and TG 4 groups than in the GA control group at 24 h after surgery ( P <0.05), suggesting a mild PONV in more patients undergoing TEAS.
CONCLUSION
TEAS has a preventive effect on PONV in patients undergoing laparoscopic surgery, which may be related to its effect in reducing serum MTL concentration. The preventive effect of TEAS of PC6 + LI4 + ST36 and PC6 +LI4 + ST36 + SP6 is similar and better than TG 2 (two acupoints) group.",2020,"The number of patients with PONV grade Ⅰ was significantly larger in the TG 2 , TG 3 and TG 4 groups than in the GA control group at 24 h after surgery ( P <0.05), suggesting a mild PONV in more patients undergoing TEAS.
","['patients undergoing laparoscopic surgery', '140 patients undergoing elective laparoscopic surgery']","['TEAS of PC6 + LI4 + ST36 and PC6 +LI4 + ST36 + SP6', 'TEAS', 'Transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation (TEAS) of different acupoint combinations', 'Midazolam, Sufentanil, Propofol, Rocuronium Bromide, etc', 'general anesthesia (GA) control, TG 2 [Neiguan (PC6) + Hegu (LI4)], TG 3 [PC6 + LI4 + Zusanli (ST36)], and TG 4 [PC6 + LI4 + ST36 + Sanyinjiao (SP6)] groups']","['postoperative nausea and vomiting (PONV) and serum motilin (MTL) content', 'serum motilin secretion', 'incidence of PONV', 'number of patients with PONV grade Ⅰ', 'serum MTL concentrations', 'incidence of early and late PONV and changes of PONV degree']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0135624', 'cui_str': 'PC6 extract'}, {'cui': 'C0450480', 'cui_str': 'LI4'}, {'cui': 'C0450533', 'cui_str': 'ST36'}, {'cui': 'C0450548', 'cui_str': 'SP6'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0069632', 'cui_str': 'rocuronium bromide'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0026594', 'cui_str': 'Motilin'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",140.0,0.0426524,"The number of patients with PONV grade Ⅰ was significantly larger in the TG 2 , TG 3 and TG 4 groups than in the GA control group at 24 h after surgery ( P <0.05), suggesting a mild PONV in more patients undergoing TEAS.
","[{'ForeName': 'Jian-Li', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}, {'ForeName': 'Xue-Jiao', 'Initials': 'XJ', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}, {'ForeName': 'Jun-Fang', 'Initials': 'JF', 'LastName': 'Rong', 'Affiliation': 'Department of Anesthesiology, Hebei General Hospital, Shijiazhuang 050051, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.200060']
2408,33269836,[Involvement of NF-κB signal pathway in acupuncture treatment of patients with rheumatoid arthritis].,"OBJECTIVE
To observe the effect of acupuncture on nuclear factor kappa-B(NF-κB)signaling pathway in patients with rheumatoid arthritis (RA), so as to explore the mechanism of acupuncture in the treatment of RA.
METHODS
A total of 120 RA patients admitted to the Xinyu Hospital of Traditional Chinese Medicine in Jiangxi Province from June 2018 to June 2019 were selected and randomly divided into a control group and a treatment group, with 60 cases in each group. The patients in the control group received oral administration of Methotrexate, (10-15) mg/time, once a week, for a total of 10 weeks. On the basis of oral administration of Methotrexate, patients in the treatment group were treated with acupuncture at Quchi(LI11), Zusanli(ST36), Taichong(LR3), Hegu(LI4), Shenshu(BL23), Geshu(BL17) and Dazhui(GV14) once daily. The treatment was conducted 6 consecutive times as a course for 10 courses. The serum C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), pain visual analog scale (VAS) score, number of swollen joints, and morning stiffness time before and after treatment were compared between the two groups. The expression levels of inflammatory related factors and NF-κB p65 protein in the synovial fluid were detected by enzyme-linked immunosorbent assay and Western blot separately.
RESULTS
After treatment, both groups had significant decrease in CRP, ESR, VAS score, number of swollen joints and morning stiffness time, levels of NF-κB p65 protein, tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and IL-6 ( P <0.05) in the joint fluid, and increase in transforming growth factor-β (TGF-β) and IL-10 ( P <0.05). After treatment, compared with the control group, CRP, ESR, VAS score and morning stiffness time, and the levels of NF-κB p65, TNF-α, IL-1β and IL-6 in the treatment group were down-regulated ( P <0.05), while the level of TGF-β was up-regulated ( P <0.05). The treatment group had a higher total effective rate than the control group[85.0%(51/60) vs 75.0%(45/60), P <0.05].
CONCLUSION
Acupuncture can inhibit the expression of NF-κB signaling pathway in RA patients, regulate the levels of related inflammatory factors, and thus improve the symptoms of RA patients.",2020,"The treatment group had a higher total effective rate than the control group[85.0%(51/60) vs 75.0%(45/60), ","['patients with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA', '120 RA patients admitted to the Xinyu Hospital of Traditional Chinese Medicine in Jiangxi Province from June 2018 to June 2019']","['acupuncture', 'Methotrexate', 'acupuncture at Quchi(LI11), Zusanli(ST36), Taichong(LR3), Hegu(LI4), Shenshu(BL23), Geshu(BL17) and Dazhui(GV14', 'Acupuncture', 'oral administration of Methotrexate']","['level of TGF-β', 'total effective rate', 'serum C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), pain visual analog scale (VAS) score, number of swollen joints, and morning stiffness time', 'CRP, ESR, VAS score and morning stiffness time, and the levels of NF-κB p65, TNF-α, IL-1β and IL-6', 'transforming growth factor-β (TGF-β) and IL-10', 'CRP, ESR, VAS score, number of swollen joints and morning stiffness time, levels of NF-κB p65 protein, tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and IL-6']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling'}, {'cui': 'C0457086', 'cui_str': 'Morning stiffness - joint'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0299809', 'cui_str': 'PAK2 Kinase'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",120.0,0.0237664,"The treatment group had a higher total effective rate than the control group[85.0%(51/60) vs 75.0%(45/60), ","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Xinyu Hospital of Traditional Chinese Medicine, Xinyu 338025, Jiangxi Province, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Xinyu Hospital of Traditional Chinese Medicine, Xinyu 338025, Jiangxi Province, China.'}, {'ForeName': 'Gen-Hong', 'Initials': 'GH', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Xinyu Hospital of Traditional Chinese Medicine, Xinyu 338025, Jiangxi Province, China.'}]",Zhen ci yan jiu = Acupuncture research,['10.13702/j.1000-0607.190848']
2409,33269819,Cerebral oxygenation and circulatory parameters during pressure-controlled vs volume-targeted mechanical ventilation in extremely preterm infants.,"BACKGROUND
Respiratory distress syndrome (RDS) is the most common cause of respiratory failure of infants born prematurely with very low birth weight (VLBW). Essential elements of RDS management include ventilatory support and endotracheal administration of a surfactant.
OBJECTIVES
To assess the effect of volume-targeted compared to pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation StO2 in extremely preterm infants.
MATERIAL AND METHODS
This prospective, cross-over trial enrolled neonates born before 28 weeks of gestation. The patients were ventilated for 3 h in pressure-controlled assist-control (PC-AC) mode, followed by 3 h of volume-guarantee assist-control ventilation (VG-AC). Pulse oximetry (saturation (SpO2) and heart rate (HR)), near-infrared spectroscopy (NIRS), StO2, and electrical cardiometry (EC) were used in monitoring of the patients.
RESULTS
Twenty preterm infants with a mean gestational age of 26 weeks were studied. The patients' mean postnatal age was 7.7 days. The SpO2 values and HR were comparable during PC-AC and VG-AC. The mean values of peak inspiratory pressure (PIP), mean airway pressure (MAP) and expiratory tidal volume (VTE) were lower, while the respiratory rate (RR) was higher during PC-VG. There were no significant differences in the mean values of StO2, but based on a comparison of the standard deviations (SD) the StO2 variability was significantly lower during VG-AC. The circulatory parameters were comparable.
CONCLUSIONS
The StO2 is more stable during VG than PC ventilation. These findings support the use of VG mode in premature infants.",2020,The SpO2 values and HR were comparable during PC-AC and VG-AC.,"['trial enrolled neonates born before 28 weeks of gestation', 'Respiratory distress syndrome (RDS', 'Twenty preterm infants with a mean gestational age of 26 weeks were studied', 'premature infants', 'extremely preterm infants', 'infants born prematurely with very low birth weight (VLBW']","['pressure-controlled vs volume-targeted mechanical ventilation', 'volume-targeted compared to pressure-controlled mechanical ventilation (MV']","['respiratory rate (RR', 'Pulse oximetry (saturation (SpO2) and heart rate (HR)), near-infrared spectroscopy (NIRS), StO2, and electrical cardiometry (EC', 'circulatory parameters and cerebral oxygenation StO2', 'mean values of peak inspiratory pressure (PIP), mean airway pressure (MAP) and expiratory tidal volume (VTE', 'Cerebral oxygenation and circulatory parameters', 'standard deviations (SD) the StO2 variability', 'SpO2 values and HR', 'mean values of StO2']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3494262', 'cui_str': 'Extremely Premature Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0419012', 'cui_str': 'Controlled mandatory ventilation'}]","[{'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0199660', 'cui_str': 'Cardiometry'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C3698222', 'cui_str': 'Expiratory tidal volume'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",20.0,0.0660285,The SpO2 values and HR were comparable during PC-AC and VG-AC.,"[{'ForeName': 'Michalina', 'Initials': 'M', 'LastName': 'Bugiera', 'Affiliation': 'Department of Neonatology, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Szczapa', 'Affiliation': 'Department of Neonatology, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Sowińska', 'Affiliation': 'Department of Computer Science and Statistics, Poznan University of Medical Sciences, Poland.'}, {'ForeName': 'Charles Christoph', 'Initials': 'CC', 'LastName': 'Roehr', 'Affiliation': 'Newborn Services, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, United Kingdom.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Szymankiewicz-Bręborowicz', 'Affiliation': 'Department of Neonatology, Poznan University of Medical Sciences, Poland.'}]",Advances in clinical and experimental medicine : official organ Wroclaw Medical University,['10.17219/acem/128198']
2410,33269808,A Randomized Trial of Modified Prolonged Exposure to Prevent the Development of Posttraumatic Stress Disorder in Patients Hospitalized With Traumatic Injuries.,"Individuals who require hospitalization after traumatic injuries are at increased risk for developing posttraumatic stress disorder (PTSD); however, few early behavioral interventions have been effective at preventing PTSD within this population. The aim of this pilot study was to assess the feasibility and effectiveness of modified prolonged exposure therapy (mPE) to prevent PTSD and depression symptoms among patients hospitalized after a DSM-5 single-incident trauma. Hospitalized patients were eligible if they screened positive for PTSD risk. Participants (N = 74) were randomly assigned in a parallel-groups design to receive mPE (n = 38) or standard of care treatment (SoC; n = 36) while admitted to the hospital after a traumatic injury. Individuals randomized to the intervention condition received one (42.1%), two (36.8%), or three sessions (15.8%) of mPE, mainly depending on length of stay. There were no significant differences between groups regarding PTSD or depression severity at 1- or 3-months posttrauma, except for more PTSD diagnoses in the intervention group after 1 month, ϕ = -.326. Intervention differences were nonsignificant when we took baseline PTSD symptoms and the nonindependence of the repeated measurements within the data into account. No adverse events were reported. Overall, mPE was no more effective than SoC for hospitalized, traumatic injury survivors with a high PTSD risk. The results may point to a need for a stepped-care approach, where intervention protocols focus on first briefly treating individuals who are actively exhibiting acute stress reactions, then extensively treating those whose symptoms do not decrease over time.",2020,"There were no significant differences between groups regarding PTSD or depression severity at 1- or 3-months posttrauma, except for more PTSD diagnoses in the intervention group after 1 month, ϕ = -.326.","['Participants (N = 74', 'patients hospitalized after a DSM-5 single-incident trauma', 'n = 38) or standard of care treatment (SoC; n = 36) while admitted to the hospital after a traumatic injury', 'Individuals who require hospitalization after traumatic injuries', 'Hospitalized patients were eligible if they screened positive for PTSD risk', 'Patients Hospitalized With Traumatic Injuries']","['modified prolonged exposure therapy (mPE', 'Modified Prolonged Exposure', 'mPE']","['adverse events', 'feasibility and effectiveness', 'PTSD or depression severity', 'PTSD diagnoses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",74.0,0.0396913,"There were no significant differences between groups regarding PTSD or depression severity at 1- or 3-months posttrauma, except for more PTSD diagnoses in the intervention group after 1 month, ϕ = -.326.","[{'ForeName': 'Sadie E', 'Initials': 'SE', 'LastName': 'Larsen', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Medical College of Wisconsin, Wauwatosa, Wisconsin, USA.'}, {'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hunt', 'Affiliation': 'Department of Surgery, Division of Trauma & Critical Care, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Geier', 'Affiliation': 'Department of Surgery, Division of Trauma & Critical Care, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Heyrman', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin Milwaukee, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Schumann', 'Affiliation': 'Department of Surgery, Division of Trauma & Critical Care, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Brandolino', 'Affiliation': 'Department of Surgery, Division of Trauma & Critical Care, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Timmer-Murillo', 'Affiliation': 'Department of Psychology, Marquette University, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Carisa', 'Initials': 'C', 'LastName': 'Bergner', 'Affiliation': 'Medical College of Wisconsin, Comprehensive Injury Center, Milwaukee, WI, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Larson', 'Affiliation': 'Department of Psychology, University of Wisconsin Milwaukee, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Terri A', 'Initials': 'TA', 'LastName': 'deRoon-Cassini', 'Affiliation': 'Department of Surgery, Division of Trauma & Critical Care, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}]",Journal of traumatic stress,['10.1002/jts.22580']
2411,33269798,"Immunogenicity and Safety of Inactivated Enterovirus 71 Vaccine in Children Aged 36-71 Months: A Double-Blind, Randomized, Controlled, Non-inferiority Phase III Trial.","BACKGROUND
The Sinovac enterovirus 71 (EV71) vaccine has been given to children aged 6-35 months with good safety, immunogenicity, and efficacy. Further exploration is needed for the application of Sinovac EV71 vaccine in older children.
METHODS
A phase III, double-blind, single-center, randomized, controlled, non-inferiority, and bridging-designed trial enrolled 300 participants aged 6-35 months and 600 participants aged 36-71 months. Non-inferiority and superiority analyses were made to determine the immunogenicity of Sinovac EV71 vaccine in older children (Older-S group), comparing with that of control EV71 vaccine in the same age group (Older-C group), or comparing with that of Sinovac EV71 vaccine in younger children (Younger-S group).
RESULTS
The seroconversion rate of anti-EV71 in Older-S group (95.5%) was superior to that of Older-C group (86.0%), and non-inferior to that of Younger-S group (98.5%). For baseline seronegative participants, the geometric mean titer of Older-S group (370.0) was non-inferior to that of Older-C group (296.2) and superior to that of Younger-S group (176.5). Incidence of adverse reactions in Older-S group (47.0%) was similar to that of Older-C group (44.8%), or Younger-S group (49.8%).
CONCLUSIONS
This study showed good safety and immunogenicity of Sinovac EV71 vaccine in children aged 36-71 months.
CLINICAL TRIALS REGISTRATION
NCT03909074.
URL
https://clinicaltrials.gov/ct2/show/NCT03909074?term=NCT03909074&draw=2&rank=1.",2020,"Non-inferiority and superiority analyses were made to determine the immunogenicity of Sinovac EV71 vaccine in older children (Older-S group), comparing with that of control EV71 vaccine in the same age group (Older-C group), or comparing with that of Sinovac EV71 vaccine in younger children (Younger-S group).
","['300 participants aged 6-35 months and 600 participants aged 36-71 months', 'older children (Older-S group', 'Aged 36-71 Months', 'Children', 'younger children (Younger-S group', 'children aged 36-71 months', 'older children']","['Sinovac EV71 vaccine', 'Inactivated Enterovirus 71 Vaccine', 'control EV71 vaccine']","['Immunogenicity and Safety', 'Incidence of adverse reactions', 'seroconversion rate of anti-EV71']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C3853962', 'cui_str': 'Enterovirus 71 infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3853962', 'cui_str': 'Enterovirus 71 infection'}]",300.0,0.324437,"Non-inferiority and superiority analyses were made to determine the immunogenicity of Sinovac EV71 vaccine in older children (Older-S group), comparing with that of control EV71 vaccine in the same age group (Older-C group), or comparing with that of Sinovac EV71 vaccine in younger children (Younger-S group).
","[{'ForeName': 'Lifen', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Yunnan Center for Disease Control and Prevention, Kunming, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Gao', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Sinovac Biotech Co., Ltd, Beijing, China.'}, {'ForeName': 'Haitao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Yunnan Center for Disease Control and Prevention, Kunming, China.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Sinovac Biotech Co., Ltd, Beijing, China.'}, {'ForeName': 'Shuangmin', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Yunnan Center for Disease Control and Prevention, Kunming, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Sinovac Biotech Co., Ltd, Beijing, China.'}, {'ForeName': 'Qunying', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'National Institutes for Food and Drug Control, Beijing, China.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Yunnan Center for Disease Control and Prevention, Kunming, China.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piaa129']
2412,33269608,Investigating the Effect of a Structured Intervention on the Development of Self-Care Behaviors With Arteriovenous Fistula in Hemodialysis Patients.,"This study aimed to assess the effectiveness of a structured intervention on the frequency of self-care behaviors with arteriovenous fistula (AVF) by patients on hemodialysis. This is a quasi-experimental study with pre- and post-measurements. Participants were assigned to an intervention group (IG) ( n = 48) or to a control group (CG) ( n = 41). IG patients were subject to a structured intervention on self-care with AVF (SISC-AVF) consisting of both a theoretical and a practical part. After SISC-AVF application, patients in the IG showed better overall self-care behaviors with AVF than patients in the CG (79.2% and 91.4%, respectively, p < .001) as well as better self-care concerning both the management of signs and symptoms (90.1% and 94.4% respectively, p = .004) and the prevention of complications (72.7% and 89.5%, respectively, p < .001). The study results suggest that the SISC-AVF had positive effects on patients in the IG.",2020,"After SISC-AVF application, patients in the IG showed better overall self-care behaviors with AVF than patients in the CG (79.2% and 91.4%, respectively, p < .001) as well as better self-care concerning both the management of signs and symptoms (90.1% and 94.4% respectively, p = .004) and the prevention of complications (72.7% and 89.5%, respectively, p < .001).","['patients on hemodialysis', 'Hemodialysis Patients']","['structured intervention on self-care with AVF (SISC-AVF', 'Structured Intervention', 'structured intervention', 'arteriovenous fistula (AVF', 'control group (CG']","['prevention of complications', 'overall self-care behaviors', 'frequency of self-care behaviors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.0222579,"After SISC-AVF application, patients in the IG showed better overall self-care behaviors with AVF than patients in the CG (79.2% and 91.4%, respectively, p < .001) as well as better self-care concerning both the management of signs and symptoms (90.1% and 94.4% respectively, p = .004) and the prevention of complications (72.7% and 89.5%, respectively, p < .001).","[{'ForeName': 'Clemente Neves', 'Initials': 'CN', 'LastName': 'Sousa', 'Affiliation': 'CINTESIS-Center for Health Technology and Services Research Faculty of Medicine, Porto University, Porto, Portugal.'}, {'ForeName': 'Ana Rita Cabral', 'Initials': 'ARC', 'LastName': 'Paquete', 'Affiliation': 'Dialysis Unit to Hospital Divino Espirito Santo, Ponta Delgada, Açores, Portugal.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Teles', 'Affiliation': 'School of Economics, University of Porto and LIAAD-INESC Porto LA, Porto, Portugal.'}, {'ForeName': 'Cristina Maria Correia Barroso', 'Initials': 'CMCB', 'LastName': 'Pinto', 'Affiliation': 'CINTESIS-Center for Health Technology and Services Research Faculty of Medicine, Porto University, Porto, Portugal.'}, {'ForeName': 'Vanessa Filipa Ferreira', 'Initials': 'VFF', 'LastName': 'Dias', 'Affiliation': 'Institute of Health Sciences, Católica University, Lisbon, Portugal.'}, {'ForeName': 'Olga Maria Pimenta Lopes', 'Initials': 'OMPL', 'LastName': 'Ribeiro', 'Affiliation': 'CINTESIS-Center for Health Technology and Services Research Faculty of Medicine, Porto University, Porto, Portugal.'}, {'ForeName': 'Carlene Souza Silva', 'Initials': 'CSS', 'LastName': 'Manzini', 'Affiliation': 'São Carlos Federal University (UFSCar), São Carlos, Brazil.'}, {'ForeName': 'Andressa Garcia', 'Initials': 'AG', 'LastName': 'Nicole', 'Affiliation': 'Federal University of Espírito Santo, Espírito Santo, Brazil.'}, {'ForeName': 'Lara Helk', 'Initials': 'LH', 'LastName': 'Souza', 'Affiliation': 'Faculdade Medicina São José Rio Preto (FAMERP), São josé do Rio Preto, Brazil.'}, {'ForeName': 'Nurten', 'Initials': 'N', 'LastName': 'Ozen', 'Affiliation': 'Florence Nightingale Hospital School of Nursing, Demiroglu Bilim University, Istanbul, Turkey.'}]",Clinical nursing research,['10.1177/1054773820974834']
2413,33269580,Efficacy and safety of three plant extracts based formulations of vagitories in the treatment of vaginitis: a randomized controlled trial.,"Aim There are more and more herbal preparations that are used for the purpose of treatment and improvement of the clinical manifestation of vaginitis not only by patients themselves, but also by healthcare professionals. Plant species, St. John's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil are all well known for their anti-inflammatory, antimicrobial and wound healing activity. This paper presents the results of a clinical study in which three herbal formulations/vagitories, based on extracts of St. John's wort, chamomile, calendula, yarrow, shepherd's purse and tea tree oil, were investigated for their effectiveness on vaginitis. Methods This was a randomized controlled clinical study that included 210 women with diagnosed vaginitis. Patients were divided into two basic groups, women in reproductive period and postmenopausal period. Three subgroups including 30 patients each received one of the three vagitorie formulations for 5 days, after which the effects on subjective and objective symptoms were monitored. Results Three types of vagitories based on plant extracts had a positive effect in the treatment of vaginitis. Vagitories based on tea tree oil showed better efficiency compared to vagitories with St. John's wort and vagitories based on extracts of five plants. Women in postmenopausal group reported better tolerability of St. John's wort-based and five herbs-based vagitories compared to tea tree oil based vagitories. Conclusion Investigated vagitories showed a positive effect on both objective and subjective symptoms of vagitnis. No serious side effects were reported.",2021,Women in postmenopausal group reported better tolerability of St. John's wort-based and five herbs-based vagitories compared to tea tree oil based vagitories.,"['210 women with diagnosed vaginitis', 'vaginitis']",['plant extracts based formulations of vagitories'],"['serious side effects', 'Efficacy and safety']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042267', 'cui_str': 'Vaginitis'}]","[{'cui': 'C0032081', 'cui_str': 'Plant extract'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",210.0,0.0414743,Women in postmenopausal group reported better tolerability of St. John's wort-based and five herbs-based vagitories compared to tea tree oil based vagitories.,"[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Durić', 'Affiliation': 'Department of Pharmacognosy, Faculty of Pharmacy, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'Kovčić Hadžiabdić', 'Affiliation': 'Faculty of Pharmacy, University of Tuzla, Tuzla, Bosnia and Herzegovina.'}, {'ForeName': 'Mahira', 'Initials': 'M', 'LastName': 'Durić', 'Affiliation': 'Institute for Health Protection of Woman and Maternity of Canton Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Nikšić', 'Affiliation': 'Department of Pharmacognosy, Faculty of Pharmacy, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Alija', 'Initials': 'A', 'LastName': 'Uzunović', 'Affiliation': 'Agency for Medicinal Products and Medical Devices, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Hurija', 'Initials': 'H', 'LastName': 'Džudžević Čančar', 'Affiliation': 'Department of Pharmacognosy, Faculty of Pharmacy, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1261-21']
2414,33269579,Intermittent traction therapy in the treatment of chronic low back pain.,"Aim To investigate the effect of intermittent traction therapy (ITT) on pain in patients with chronic low back pain (CLBP). Methods A total of 81 patients with CLBP were included: experimental group received ITT (n=40) and control group received conservative physical treatment (n=41) 10 times for two weeks. A visual analogue scale (VAS) was used for measuring low back pain. Results In the experimental group, 26 (out of 40; 65.0%) patients were females, in the control group 20 (out of 41; 48.8%) were females ( p =0.141). In a within-group comparison, median of VAS value was significantly decreased in both groups after ITT. A comparison of pre-intervention and post-intervention VAS value showed no statistically significant difference. Females from the experimental group had a significantly greater decrease of VAS compared with females from the control group. Patients in the ITT group with L5/S1 level of hernia had lower estimated marginal mean of VAS scale compared to the control group, as well the patients with left side of leg pain. Conclusion: Intermittent traction therapy is an effective treatment for pain reduction in patients with chronic low back pain.",2021,"Patients in the ITT group with L5/S1 level of hernia had lower estimated marginal mean of VAS scale compared to the control group, as well the patients with left side of leg pain.","['patients with chronic low back pain', '81 patients with CLBP', 'patients with chronic low back pain (CLBP', 'chronic low back pain']","['intermittent traction therapy (ITT', 'control group received conservative physical treatment', 'ITT', 'Intermittent traction therapy']","['L5/S1 level of hernia', 'median of VAS value', 'VAS', 'pain reduction', 'visual analogue scale (VAS', 'VAS scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0565524', 'cui_str': 'Intermittent traction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",81.0,0.0286274,"Patients in the ITT group with L5/S1 level of hernia had lower estimated marginal mean of VAS scale compared to the control group, as well the patients with left side of leg pain.","[{'ForeName': 'Edina', 'Initials': 'E', 'LastName': 'Tanović', 'Affiliation': 'Clinic for Physical Medicine and Rehabilitation, Clinical Centre, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Čelik', 'Affiliation': 'Clinic for Physical Medicine and Rehabilitation, Clinical Centre, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Đemil', 'Initials': 'Đ', 'LastName': 'Omerović', 'Affiliation': 'Ortopaedics and Traumatology Clinic; Clinical Centre, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Zovko Omeragić', 'Affiliation': 'Faculty of Health Studies, University of Mostar, Mostar, Bosnia and Herzegovina.'}, {'ForeName': 'Amila', 'Initials': 'A', 'LastName': 'Jaganjac', 'Affiliation': 'Faculty of Health Studies, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Hadžan', 'Initials': 'H', 'LastName': 'Konjo', 'Affiliation': 'Faculty of Health Studies, University of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Emina', 'Initials': 'E', 'LastName': 'Rovčanin', 'Affiliation': 'Public Health Institution Pharmacies of Sarajevo, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Omerović', 'Affiliation': 'Private Health Institution Verdant Pharmacies, Sarajevo, Bosnia and Herzegovina.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1252-21']
2415,33269553,Comparison of high-flow oxygenation with noninvasive ventilation in COPD exacerbation: A crossover clinical trial.,"OBJECTIVES
To compare the therapeutic effects of high-flow-oxygen-Therapy (HFT) and noninvasive-ventilation (NIV) for stabilizing chronic obstructive pulmonary disease during exacerbation.
METHODS
In this randomized clinical trial at Masih-Daneshvari hospital, between July 2019 and Oct 2019, 30 exacerbated-COPD-patient with PaCO2 64.58±11.61 mmHg, Respiratory Rate 24.43±2.75 and PH 7.31±0.02 were divided into two groups, N= 15. By a simple randomized allocation, patients receive either NIV or HFT for one hour, and following a washout period of 30 minutes, they switched to the other treatment option. Arterial Blood Gas Parameters, as well as Respiratory Rate (RR), Dyspnea Score, Heart Rate (HR), and Oxygen Saturation (SO2), were compared before and after the intervention and between groups.
RESULTS
Baseline patient characteristics were similar in two groups. Pre and post-analysis revealed that in both groups, all improved significantly. After the first period, there was no difference in all parameters between groups except for SO2 which was significantly higher in HFT (%92.1± 1) than that of NIV (%89± 1), P=0.001. Likewise, following the washout period, patients in HFT and NIV had a dyspnea score of 1.93± 0.7 and 2.73±0.9 respectively, P=0.01. No carryover-effect and was observed but period effect was significant for some outcomes. A significant improvement in SO2 and HR was observed by HFT according to treatment effect by combining two periods' results. During the study, no side effects were reported.
CONCLUSION
In this short-term study HFT appears feasible for patients with COPD exacerbation to reduce dyspnea score and improve respiratory distress.",2020,In this short-term study HFT appears feasible for patients with COPD exacerbation to reduce dyspnea score and improve respiratory distress.,"['COPD exacerbation', 'stabilizing chronic obstructive pulmonary disease during exacerbation', 'patients with COPD exacerbation', 'Masih-Daneshvari hospital, between July 2019 and Oct 2019, 30 exacerbated-COPD-patient with PaCO2 64.58±11.61 mmHg, Respiratory Rate 24.43±2.75 and PH 7.31±0.02 were divided into two groups, N= 15']","['HFT', 'high-flow-oxygen-Therapy (HFT) and noninvasive-ventilation (NIV', 'high-flow oxygenation with noninvasive ventilation', 'NIV or HFT']","['Arterial Blood Gas Parameters, as well as Respiratory Rate (RR), Dyspnea Score, Heart Rate (HR), and Oxygen Saturation (SO2', 'SO2 and HR', 'SO2', 'dyspnea score', 'dyspnea score and improve respiratory distress']","[{'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]","[{'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0038777', 'cui_str': 'Sulfur Dioxide'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}]",,0.114896,In this short-term study HFT appears feasible for patients with COPD exacerbation to reduce dyspnea score and improve respiratory distress.,"[{'ForeName': 'Abbs', 'Initials': 'A', 'LastName': 'Rezaee', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Fakharian', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghorbani', 'Affiliation': 'Tracheal Diseases Research Center (TDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Esmaeeil', 'Initials': 'E', 'LastName': 'Idani', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Abedini', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamaati', 'Affiliation': 'Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",The clinical respiratory journal,['10.1111/crj.13315']
2416,33269530,"The effect of semaglutide 2.4 mg once weekly on energy intake, appetite, control of eating and gastric emptying in subjects with obesity.","AIMS
This trial investigated the effects of once-weekly subcutaneous semaglutide 2.4 mg on gastric emptying, appetite, and energy intake in subjects with obesity.
MATERIALS AND METHODS
A double-blind, parallel-group trial was conducted in 72 adults with obesity, randomized to once-weekly subcutaneous semaglutide (dose-escalated to 2.4 mg) or placebo for 20 weeks. Gastric emptying was assessed using paracetamol absorption following standardized breakfast. Subject-reported appetite ratings and Control of Eating Questionnaire (CoEQ) responses were assessed, and energy intake was measured during ad libitum lunch.
RESULTS
Paracetamol AUC 0-5h,para (primary endpoint) was increased by 8% (P = 0.005) with semaglutide 2.4 mg versus placebo at week 20 (non-significant when corrected for week 20 body weight; P = 0.12). No effect was seen on AUC 0-1h,para , C max,para , or t max,para . Ad libitum energy intake was 35% lower with semaglutide versus placebo (1736 versus 2676 kJ; estimated treatment difference: -940 kJ; P <0.0001). Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety when compared with placebo (all P <0.02). The CoEQ indicated better control of eating and fewer/weaker food cravings with semaglutide versus placebo (P <0.05). Bodyweight was reduced by 9.9% with semaglutide and 0.4% with placebo. Safety was consistent with the known profile of semaglutide.
CONCLUSIONS
In subjects with obesity, once-weekly subcutaneous semaglutide 2.4 mg suppressed appetite, improved control of eating, and reduced food cravings, ad libitum energy intake and bodyweight versus placebo. There was no evidence of delayed gastric emptying at week 20, assessed indirectly via paracetamol absorption. This article is protected by copyright. All rights reserved.",2020,"Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety when compared with placebo (all P <0.02).","['subjects with obesity', '72 adults with obesity']","['subcutaneous semaglutide', 'placebo']","['gastric emptying, appetite, and energy intake', 'AUC 0-1h,para , C max,para , or t max,para ', 'control of eating and fewer/weaker food cravings', 'Ad libitum energy intake', 'appetite, improved control of eating, and reduced food cravings', 'appetite ratings and Control of Eating Questionnaire (CoEQ) responses', 'delayed gastric emptying', 'Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety', 'Gastric emptying', 'Bodyweight', 'energy intake, appetite, control of eating and gastric emptying']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",72.0,0.463599,"Semaglutide reduced hunger and prospective food consumption, and increased fullness and satiety when compared with placebo (all P <0.02).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Friedrichsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Breitschaft', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Tadayon', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Wizert', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Dorthe', 'Initials': 'D', 'LastName': 'Skovgaard', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14280']
2417,33269455,Long-term (> 10 years) clinical outcomes of instrumented posterolateral fusion for spondylolisthesis.,"PURPOSE
Despite the rapid increase in instrumented spinal fusions for a variety of indications, most studies focus on short-term fusion rates. Long-term clinical outcomes are still scarce and inconclusive. This study investigated clinical outcomes > 10 years after single-level instrumented posterolateral spinal fusion for lumbar degenerative or isthmic spondylolisthesis with neurological symptoms.
METHODS
Cross-sectional long-term follow-up among the Dutch participants of an international multicenter randomized controlled trial comparing osteogenic protein-1 with autograft. Clinical outcomes were assessed using the Oswestry Disability Index (ODI), EQ-5D-3L and visual analogue scale (VAS) for leg and back pain, as well as questions on satisfaction with treatment and additional surgery.
RESULTS
The follow-up rate was 73% (41 patients). At mean 11.8 (range 10.1-13.7) years after surgery, a non-significant deterioration of clinical outcomes compared to 1-year follow-up was observed. The mean ODI was 20 ± 19, mean EQ-5D-3L index score 0.784 ± 0.251 and mean VAS for leg and back pain, respectively, 34 ± 33 and 31 ± 28. Multiple regression showed that diagnosis (degenerative vs. isthmic spondylolisthesis), graft type (OP-1 vs. autograft) and 1-year fusion status (fusion vs. no fusion) were not predictive for the ODI at long-term follow-up (p = 0.389). Satisfaction with treatment was excellent and over 70% of the patients reported lasting improvement in back and/or leg pain. No revision surgeries for non-union were reported.
CONCLUSION
This study showed favourable clinical outcomes > 10 years after instrumented posterolateral spinal fusion and supports spondylolisthesis with neurological symptoms as indication for fusion surgery.",2020,"The mean ODI was 20 ± 19, mean EQ-5D-3L index score 0.784 ± 0.251 and mean VAS for leg and back pain, respectively, 34 ± 33 and 31 ± 28.",['for lumbar degenerative or isthmic spondylolisthesis with neurological symptoms'],"['osteogenic protein-1 with autograft', 'single-level instrumented posterolateral spinal fusion']","['mean ODI', 'Satisfaction', 'Oswestry Disability Index (ODI), EQ-5D-3L and visual analogue scale (VAS) for leg and back pain, as well as questions on satisfaction with treatment and additional surgery', 'graft type (OP-1 vs. autograft) and 1-year fusion status', 'back and/or leg pain']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0410656', 'cui_str': 'Isthmic spondylolisthesis'}, {'cui': 'C0235031', 'cui_str': 'Neurological symptom'}]","[{'cui': 'C0083867', 'cui_str': 'Osteogenic Protein-1'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1445625', 'cui_str': 'eptotermin alfa'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}]",,0.0472636,"The mean ODI was 20 ± 19, mean EQ-5D-3L index score 0.784 ± 0.251 and mean VAS for leg and back pain, respectively, 34 ± 33 and 31 ± 28.","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Lehr', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, 85500, 3508 GA, Utrecht, The Netherlands. a.m.lehr@umcutrecht.nl.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Delawi', 'Affiliation': 'Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'J L C', 'Initials': 'JLC', 'LastName': 'van Susante', 'Affiliation': 'Department of Orthopaedic Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Verschoor', 'Affiliation': 'Department of Orthopaedic Surgery, Jeroen Bosch Hospital, Den Bosch, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wolterbeek', 'Affiliation': 'Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'F C', 'Initials': 'FC', 'LastName': 'Oner', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, 85500, 3508 GA, Utrecht, The Netherlands.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, 85500, 3508 GA, Utrecht, The Netherlands.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06671-6']
2418,33269429,Evaluation of reflux following sleeve gastrectomy and one anastomosis gastric bypass: 1-year results from a randomized open-label controlled trial.,"BACKGROUND
Recent reports have demonstrated that de novo reflux and worsening of pre-existing symptoms occur after SG; concerns are still expressed about the risk of symptomatic biliary reflux gastritis and oesophagitis. The aim of our study was to investigate and compare the rate of postoperative acid and non-acid reflux following Mini-/One anastomosis gastric bypass (MGB/OAGB) and laparoscopic sleeve gastrectomy (LSG).
STUDY DESIGN
A prospective randomized open-label, controlled trial registered on clinicaltrial.gov (NCT number: NCT02987673) has been carried out to evaluate esophagogastric junction exposure to reflux in the first year after MGB/OAGB and LSG using high impedance manometry, endoscopy, and a validated questionnaire.
RESULTS
A total of 58 individuals were eventually enrolled in this trial and represented the per-protocol population (n = 28 MGB/OAGB, n = 30 LSG). No difference was found between the two groups in terms of demographic characteristics, PAGI-SYM score, acid exposure time percent of the esophagus (AET%), esophagitis, and other HRiM and MII-pH data at baseline. Comparing MII-pH outcomes of the two groups, AET% resulted significantly higher after LSG at 12 months. Endoscopic findings showed a significant increase of esophagitis ≥ B in the LSG group after 1 year; postoperative esophagitis ≥ B resulted also significantly worsened after LSG when compared to MGB/OAGB.
CONCLUSION
Since AET% and rate of esophagitis are significantly higher after LSG when compared to MGB/OAGB, this procedure should be preferred in case of preoperative subclinical reflux or low grade (A) esophagitis.",2020,"No difference was found between the two groups in terms of demographic characteristics, PAGI-SYM score, acid exposure time percent of the esophagus (AET%), esophagitis, and other HRiM and MII-pH data at baseline.","['A total of 58 individuals were eventually enrolled in this trial and represented the per-protocol population (n\u2009=\u200928 MGB/OAGB, n\u2009=\u200930 LSG']","['sleeve gastrectomy and one anastomosis gastric bypass', 'Mini-/One anastomosis gastric bypass (MGB/OAGB) and laparoscopic sleeve gastrectomy (LSG', 'LSG']","['rate of postoperative acid and non-acid reflux', 'esophagitis\u2009≥\u2009B', 'rate of esophagitis', 'demographic characteristics, PAGI-SYM score, acid exposure time percent of the esophagus (AET%), esophagitis, and other HRiM and MII-pH data']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0373680', 'cui_str': 'Myoglobin measurement'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0373680', 'cui_str': 'Myoglobin measurement'}, {'cui': 'C1960816', 'cui_str': 'Laparoscopic sleeve gastrectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}]",58.0,0.0495635,"No difference was found between the two groups in terms of demographic characteristics, PAGI-SYM score, acid exposure time percent of the esophagus (AET%), esophagitis, and other HRiM and MII-pH data at baseline.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Musella', 'Affiliation': 'Advanced Biomedical Sciences Department, Naples ""Federico II"" University, AOU ""Federico II"" - Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vitiello', 'Affiliation': 'Advanced Biomedical Sciences Department, Naples ""Federico II"" University, AOU ""Federico II"" - Via S. Pansini 5, 80131, Naples, Italy. antoniovitiello_@hotmail.it.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Berardi', 'Affiliation': 'Advanced Biomedical Sciences Department, Naples ""Federico II"" University, AOU ""Federico II"" - Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Nunzio', 'Initials': 'N', 'LastName': 'Velotti', 'Affiliation': 'Advanced Biomedical Sciences Department, Naples ""Federico II"" University, AOU ""Federico II"" - Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Pesce', 'Affiliation': 'Clinical Medicine and Surgery Department, Naples ""Federico II"" University, AOU ""Federico II"" - Via S. Pansini 5, 80131, Naples, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Sarnelli', 'Affiliation': 'Clinical Medicine and Surgery Department, Naples ""Federico II"" University, AOU ""Federico II"" - Via S. Pansini 5, 80131, Naples, Italy.'}]",Surgical endoscopy,['10.1007/s00464-020-08182-3']
2419,33269417,Response-shift effects in neuromyelitis optica spectrum disorder: a secondary analysis of clinical trial data.,"BACKGROUND
Researchers have long posited that response-shift effects may obfuscate treatment effects. The present work investigated possible response-shift effects in a recent clinical trial testing a new treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD). This pivotal trial provided impressive support for the drug Eculizumab in preventing relapse, but less strong or null results as the indicators became more subjective or evaluative. This pattern of results suggests that response-shift effects are present.
METHODS
This secondary analysis utilized data from a randomized, double-blind trial evaluating the impact of Eculizumab in preventing relapses in 143 people with NMOSD. Treatment arm and then relapse status were hypothesized 'catalysts' of response shift in two series of analyses. We devised a ""de-constructed"" version of Oort structural-equation modeling using random-effects modeling for use in small samples. This method begins by testing an omnibus response-shift hypothesis and then, pending a positive result, implements a series of random-effects models to elucidate specific response-shift effects.
RESULTS
In the omnibus test, the 'standard quality-of-life (QOL) model' captured substantially less well the experience of placebo as compared to Eculizumab group. Recalibration and reconceptualization response-shift effects were detected. Detected relapse-related response shifts included recalibration, reprioritization, and reconceptualization.
CONCLUSIONS
Trial patients experienced response shifts related to treatment- and relapse-related experiences. Published trial results likely under-estimated Eculizumab vs. Placebo differences due to recalibration and reconceptualization, and relapse effects due to recalibration, reprioritization, and reconceptualization. This novel random-effects- model application builds on response-shift theory and provides a small-sample method for better estimating treatment effects in clinical trials.",2020,"In the omnibus test, the 'standard quality-of-life (QOL) model' captured substantially less well the experience of placebo as compared to Eculizumab group.","['143 people with NMOSD', 'neuromyelitis optica spectrum disorder', 'Neuromyelitis Optica Spectrum Disorder (NMOSD']","['placebo', 'Eculizumab']","['Detected relapse-related response shifts included recalibration, reprioritization, and reconceptualization', 'Recalibration and reconceptualization response-shift effects']","[{'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1541483', 'cui_str': 'eculizumab'}]","[{'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",143.0,0.219473,"In the omnibus test, the 'standard quality-of-life (QOL) model' captured substantially less well the experience of placebo as compared to Eculizumab group.","[{'ForeName': 'Carolyn E', 'Initials': 'CE', 'LastName': 'Schwartz', 'Affiliation': 'DeltaQuest Foundation, Inc, 31 Mitchell Road, Concord, MA, 01742, USA. carolyn.schwartz@deltaquest.org.'}, {'ForeName': 'Roland B', 'Initials': 'RB', 'LastName': 'Stark', 'Affiliation': 'DeltaQuest Foundation, Inc, 31 Mitchell Road, Concord, MA, 01742, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Stucky', 'Affiliation': 'DeltaQuest Foundation, Inc, 31 Mitchell Road, Concord, MA, 01742, USA.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02707-y']
2420,33269395,Clinical switching strategies of various antidepressants to Vortioxetine in the PREDDICT trial.,"BACKGROUND
Partial response to antidepressant medication, as well as relapse and treatment resistance are common in Major Depressive Disorder (MDD). Therefore, for most patients with MDD there will be a need to consider changing antidepressant medication at some stage during the course of the illness. The PREDDICT study investigates the efficacy of augmenting vortioxetine with celecoxib.
METHODS
We describe the method used in the PREDDICT study to change participants, who were already taking antidepressant medication at the time of the screening visit, to vortioxetine. We used a cross-titration to change study participants to vortioxetine.
RESULTS
Out of a total of 122 study participants who were randomized to receive vortioxetine plus celecoxib or vortioxetine plus placebo at the study baseline visit, 82 were taking antidepressant medication (other than vortioxetine) prior to randomization. These medications were selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors, tricyclic antidepressants, mirtazapine, or agomelatine. Eighty of these 82 participants completed the changeover to vortioxetine, as well as the study baseline visit. We found side effects were generally mild during this changeover period. In addition, there was a reduction in mean total MADRS score of 2.5 (standard deviation (SD) 6.0) from study baseline to week 2, and a further reduction in mean total MADRS of 2.5 (SD 5.9) from week 2 to week 4.
CONCLUSION
Changing other antidepressants to vortioxetine can be done safely, and was generally well tolerated. However, there were some antidepressant classes, in particular monoamine oxidase inhibitors which require a washout period, that were not represented in this study.",2020,"In addition, there was a reduction in mean total MADRS score of 2.5 (standard deviation (SD) 6.0) from study baseline to week 2, and a further reduction in mean total MADRS of 2.5 (SD 5.9) from week 2 to week 4.
","['Eighty of these 82 participants completed the changeover to', 'Out of a total of 122 study participants', 'change participants, who were already taking antidepressant medication at the time of the screening visit, to']","['antidepressant medication (other than vortioxetine', 'vortioxetine plus celecoxib or vortioxetine plus placebo', 'vortioxetine', 'vortioxetine with celecoxib', 'Vortioxetine']","['tolerated', 'side effects', 'mean total MADRS score', 'mean total MADRS']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3661282', 'cui_str': 'vortioxetine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",122.0,0.0869567,"In addition, there was a reduction in mean total MADRS score of 2.5 (standard deviation (SD) 6.0) from study baseline to week 2, and a further reduction in mean total MADRS of 2.5 (SD 5.9) from week 2 to week 4.
","[{'ForeName': 'Natalie T', 'Initials': 'NT', 'LastName': 'Mills', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sampson', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Célia', 'Initials': 'C', 'LastName': 'Fourrier', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Bernhard T', 'Initials': 'BT', 'LastName': 'Baune', 'Affiliation': 'Discipline of Psychiatry, Adelaide Medical School, University of Adelaide, Adelaide, Australia.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa092']
2421,33269313,The impact of distraction minimization on endoscopic mentoring and performance.,"Background and study aims Endoscopic mentoring requires active attention by the preceptor. Unfortunately, sources of distraction are abundant during endoscopic precepting. The impact of distraction minimization on endoscopic mentoring and performance is unknown. Methods Fellow and attending preceptors were paired and randomized in a prospective crossover design to perform esophagogastroduodenoscopy (EGD) and/or colonoscopy in either a ""distraction minimization"" (DM) or a ""standard"" (S) room. Cell phones, pagers, music, and computers were not permitted in DM rooms. S rooms operated under typical conditions. Fellows and attendings then completed a survey. The primary outcome was fellow satisfaction with mentoring experience (visual analogue scale: 0 = min,100 = max). Additional fellow outcomes included satisfaction of attending attentiveness, identifying landmarks, communication, and distractedness; attending outcomes included satisfaction with mentoring, attentiveness, communication, and distractedness. Endoscopic performance measures included completion of EGD, cecal intubation rate, cecal intubation time, withdrawal time, total procedure time, attending assistance, and polyp detection rate. A paired t -test was used to compare mean differences (MD) between rooms; significance set at P < 0.05. Results Eight fellows and seven attendings completed 164 procedures. Despite a trend toward less distraction between rooms (DM = 12.5 v. S = 18.3, MD = 4.1, P = 0.17), there was no difference in fellow satisfaction with training/mentoring (DM = 93, S = 93, MD = -0.04, P = 0.97), attentiveness (DM = 95, S = 92, MD = 0.86, P = 0.77), identifying pathology/landmarks (DM = 94, S = 94, MD = -1.72, P = 0.56), or communication (DM = 95, S = 95,MD = 1.0, P = 0.37). Similarly, there was no difference between rooms for any attending outcome measures or performance metrics. Conclusions DM did not improve perceived quality of endoscopic mentoring or performance for fellows or attendings; however, reduced distraction may improve attending engagement/availability.",2020,"Conclusions DM did not improve perceived quality of endoscopic mentoring or performance for fellows or attendings; however, reduced distraction may improve attending engagement/availability.",['Methods \u2002Fellow and attending preceptors'],"['distraction minimization', 'esophagogastroduodenoscopy (EGD) and/or colonoscopy in either a ""distraction minimization"" (DM) or a ""standard"" (S) room']","['satisfaction of attending attentiveness, identifying landmarks, communication, and distractedness; attending outcomes included satisfaction with mentoring, attentiveness, communication, and distractedness', 'fellow satisfaction', 'fellow satisfaction with mentoring experience (visual analogue scale: 0\u200a=\u200amin,100\u200a=\u200amax', 'completion of EGD, cecal intubation rate, cecal intubation time, withdrawal time, total procedure time, attending assistance, and polyp detection rate']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",,0.292452,"Conclusions DM did not improve perceived quality of endoscopic mentoring or performance for fellows or attendings; however, reduced distraction may improve attending engagement/availability.","[{'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Rice', 'Affiliation': 'Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee, United States.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Slaughter', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, Tennessee, United States.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Smalley', 'Affiliation': 'Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee, United States.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Obstein', 'Affiliation': 'Division of Gastroenterology, Vanderbilt University, Nashville, Tennessee, United States.'}]",Endoscopy international open,['10.1055/a-1265-6731']
2422,33269258,Wavelet and pain rating index for inhalation anesthesia: A randomized controlled trial.,"BACKGROUND
Wavelet index (WLi) and pain rating index (PRi) are new parameters for regulating general anesthesia depth based on wavelet analysis.
AIM
To investigate the safety and efficacy of using WLi or PRi in sevoflurane anesthesia.
METHODS
This randomized controlled trial enrolled 66 patients scheduled for elective posterior lumbar interbody fusion surgery under sevoflurane anesthesia between September 2017 and February 2018. A random number generator was used to assign the eligible patients to three groups: Systolic blood pressure (SBP) monitoring group, WLi monitoring group, and PRi monitoring group. The main anesthesiologist was aware of the patient grouping and intervention used. The primary endpoint was anesthesia recovery time. Secondary endpoints included extubation time, sevoflurane consumption, number of unwanted events/ interventions, number of adverse events and postoperative visual analogue scale for pain.
RESULTS
A total of 62 patients were included in the final analysis (SBP group, n = 21; WLi group, n = 21; and PRi group, n = 20). There were no significant differences among the three groups in patient age, gender distribution, body mass index, American Society of Anesthesiologists class, duration of surgery, or duration of anesthesia. Anesthesia recovery time was shorter in the WLi and PRi groups than in the SBP group with no significant difference between the WLi and PRi groups. Extubation time was shorter in the WLi and PRi groups than in the SBP group. Sevoflurane consumption was lower in the WLi and PRi groups than in the SBP group. Nicardipine was more commonly needed to treat hypertension in the WLi and PRi groups than in the SBP group.
CONCLUSION
Regulation of sevoflurane anesthesia depth with WLi or PRi reduced anesthesia recovery time, extubation time and sevoflurane consumption without intraoperative unwanted events.",2020,Anesthesia recovery time was shorter in the WLi and PRi groups than in the SBP group with no significant difference between the WLi and PRi groups.,"['66 patients scheduled for elective posterior lumbar interbody fusion surgery under sevoflurane anesthesia between September 2017 and February 2018', 'A total of 62 patients were included in the final analysis (SBP group, n = 21; WLi group, n = 21; and PRi group, n = 20']","['sevoflurane anesthesia depth with WLi or PRi', 'WLi or PRi', 'Nicardipine', 'SBP', 'Systolic blood pressure (SBP) monitoring group, WLi monitoring group, and PRi monitoring group']","['pain rating index (PRi', 'Wavelet and pain rating index', 'safety and efficacy', 'Extubation time', 'Sevoflurane consumption', 'Anesthesia recovery time', 'anesthesia recovery time, extubation time and sevoflurane consumption', 'treat hypertension', 'extubation time, sevoflurane consumption, number of unwanted events/ interventions, number of adverse events and postoperative visual analogue scale for pain', 'anesthesia recovery time']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",66.0,0.0621349,Anesthesia recovery time was shorter in the WLi and PRi groups than in the SBP group with no significant difference between the WLi and PRi groups.,"[{'ForeName': 'Jian-Wen', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Sanbo Brain Hospital, Capital Medical University, Beijing 100093, China.'}, {'ForeName': 'Zhi-Gan', 'Initials': 'ZG', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, Shanxi Dayi Hospital, Taiyuan 030032, Shanxi Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Department of Anesthesiology, Shanxi Dayi Hospital, Taiyuan 030032, Shanxi Province, China.'}, {'ForeName': 'Chong-Fang', 'Initials': 'CF', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Shanxi Dayi Hospital, Taiyuan 030032, Shanxi Province, China.'}, {'ForeName': 'Bao-Guo', 'Initials': 'BG', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Sanbo Brain Hospital, Capital Medical University, Beijing 100093, China. wbgttyy@163.com.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i21.5221']
2423,33269253,Efficacy and safety of S-1 maintenance therapy in advanced non-small-cell lung cancer patients.,"BACKGROUND
Previous reports have demonstrated that S-1 has remarkable effects in the maintenance treatment of advanced non-small-cell lung cancer (NSCLC), and has less toxic and side effects than conventional drugs.
AIM
To investigate the efficacy and safety of S-1 maintenance therapy in patients with advanced NSCLC.
METHODS
Ninety-four patients with NSCLC admitted to our hospital from September 2015 to April 2018 were included in the study and divided into the S-1 group (47 cases) and the gemcitabine group (47 cases) by random digital table method. The S-1 group was treated with S-1, while the gemcitabine group received gemcitabine treatment. The clinical efficacy and quality of life of the patients after treatment in the two groups were evaluated.
RESULTS
There was no significant difference in the total effectiveness rate between the two groups ( P = 0.519). The quality-of-life scores indicated that there was no significant difference between the two groups in terms of four dimensions of the GQOLI-74 questionnaire ( P = 0.518, 0.094, 0.338, 0.418). The incidence of nausea and vomiting, granulocytopenia and diarrhea in the S-1 group was significantly lower than that in the gemcitabine group ( P = 0.001, 0.001 and 0.001, respectively). There was no significant difference in the incidence of thrombocytopenia ( P = 0.366), the progression-free survival ( P = 0.064), and the survival between the two groups ( P = 0.050).
CONCLUSION
S-1 maintenance therapy shows a significant therapeutic effect in patients with advanced NSCLC. It has the same clinical efficacy as gemcitabine, but with less toxic and side effects than conventional drugs.",2020,"The quality-of-life scores indicated that there was no significant difference between the two groups in terms of four dimensions of the GQOLI-74 questionnaire ( P = 0.518, 0.094, 0.338, 0.418).","['patients with advanced NSCLC', 'advanced non-small-cell lung cancer patients', 'Ninety-four patients with NSCLC admitted to our hospital from September 2015 to April 2018 were included in the study and divided into the S-1 group (47 cases) and the']","['gemcitabine', 'S-1 maintenance therapy', 'gemcitabine treatment']","['clinical efficacy and quality of life', 'survival', 'incidence of thrombocytopenia', 'progression-free survival', 'Efficacy and safety', 'GQOLI-74 questionnaire', 'efficacy and safety', 'total effectiveness rate', 'quality-of-life scores', 'toxic and side effects', 'nausea and vomiting, granulocytopenia and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0001824', 'cui_str': 'Agranulocytosis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",94.0,0.0262749,"The quality-of-life scores indicated that there was no significant difference between the two groups in terms of four dimensions of the GQOLI-74 questionnaire ( P = 0.518, 0.094, 0.338, 0.418).","[{'ForeName': 'Xiao-Wei', 'Initials': 'XW', 'LastName': 'Cheng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Panzhihua Central Hospital, Panzhihua 617067, Sichuan Province, China.'}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Leng', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Panzhihua Central Hospital, Panzhihua 617067, Sichuan Province, China.'}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Mu', 'Affiliation': 'Department of Ultrasound, Panzhihua Central Hospital, Panzhihua 617067, Sichuan Province, China. 470589248@qq.com.'}]",World journal of clinical cases,['10.12998/wjcc.v8.i21.5172']
2424,33269215,Patients' perspectives on the conventional synthetic cast vs a newly developed open cast for ankle sprains.,"BACKGROUND
Orthopedic physicians typically apply a cast to immobilize a body part that has been injured. There have been no significant structural changes or advances in synthetic casts since the development of the modern cast. The Opencast ® is a recently developed type of cast that allows ventilation and direct visual inspection of the skin to avoid cast-related complications. Although this novel cast appears to have more benefits than the conventional synthetic cast, its clinical efficacy and advantages have not been established.
AIM
To investigate the clinical efficacy and advantages of the newly developed Opencast ® based on patients' perspectives in those with ankle inversion injury.
METHODS
A specifically designed questionnaire consisting of 19 items was used to compare patients' opinions and concerns of the Opencast ® and the conventional synthetic cast. The items were focused on subjective patient satisfaction, discomfort, and adverse effects while wearing the cast. Patients with an ankle inversion injury diagnosed as a high-grade ankle sprain were enrolled. The subjects were randomized and instructed to fill the questionnaire after wearing a synthetic cast or an Opencast ® for 2 wk. They were then required to fill the questionnaire again, after switching to the alternative type of cast for 2 more weeks.
RESULTS
A total of 22 subjects participated in the study. The synthetic cast appeared to be more rigid and stable than the Opencast ® , but there was no significant difference in the amount of pain relief. The likelihood of adverse effects when wearing the synthetic cast was significantly higher. Patient satisfaction tended to be rated higher after wearing the Opencast ® . Opencast ® showed more subjective vulnerability than the synthetic cast, but there was no significant difference in the redo rate. Patients were more anxious about removal of the synthetic cast than of the Opencast ® .
CONCLUSION
The results indicate that the Opencast ® could replace the conventional synthetic cast as it offers increased patient satisfaction, which would in turn increase compliance to treatment.",2020,"Opencast ® showed more subjective vulnerability than the synthetic cast, but there was no significant difference in the redo rate.","['22 subjects participated in the study', 'Patients with an ankle inversion injury diagnosed as a high-grade ankle sprain were enrolled', ""patients' perspectives in those with ankle inversion injury""]","['conventional synthetic cast vs a newly developed open cast', 'questionnaire after wearing a synthetic cast or an Opencast ® for 2 wk', 'Opencast ® and the conventional synthetic cast']","['pain relief', 'redo rate', 'subjective patient satisfaction, discomfort, and adverse effects', 'Patient satisfaction', 'patient satisfaction', 'subjective vulnerability', 'anxious about removal of the synthetic cast']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0021943', 'cui_str': 'Chromosome inversion'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0179686', 'cui_str': 'Cast'}]",22.0,0.0434427,"Opencast ® showed more subjective vulnerability than the synthetic cast, but there was no significant difference in the redo rate.","[{'ForeName': 'Byung Cho', 'Initials': 'BC', 'LastName': 'Min', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Gyeonggi, South Korea.'}, {'ForeName': 'Ji Soo', 'Initials': 'JS', 'LastName': 'Yoon', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Gyeonggi, South Korea.'}, {'ForeName': 'Chin Youb', 'Initials': 'CY', 'LastName': 'Chung', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Gyeonggi, South Korea.'}, {'ForeName': 'Moon Seok', 'Initials': 'MS', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Gyeonggi, South Korea.'}, {'ForeName': 'Ki Hyuk', 'Initials': 'KH', 'LastName': 'Sung', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Gyeonggi, South Korea.'}, {'ForeName': 'Kyoung Min', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopaedic Surgery, Seoul National University Bundang Hospital, Seongnam 463-707, Gyeonggi, South Korea. oasis100@empal.com.'}]",World journal of orthopedics,['10.5312/wjo.v11.i11.492']
2425,33269193,Increasing Exercise Intensity: Teaching High-Intensity Interval Training to Individuals with Developmental Disabilities Using a Lottery Reinforcement System.,"Rates of overweight and obesity are above 70% in typically developing adults in the United States, with higher rates observed in individuals diagnosed with developmental disability (DD). Lottery reinforcement systems have been validated as effective exercise interventions for individuals with DD. Although high-intensity interval training (HIIT) has demonstrated health benefits, it has not been studied using individuals within this population. The purpose of this study was to implement a lottery reinforcement system to systematically increase heart rate (HR) during 30-min HIIT sessions with 3 adults with DD. Results demonstrated increases in HR from below to within the prescribed range in all 3 participants. For 1 participant, weight decreased by 10.8 pounds during the 9-week program. Implications include that lottery systems increase exercise intensity with adults with DD, that HR during exercise can be reliably controlled using a lottery system, and that similar programs may result in health benefits.",2020,Results demonstrated increases in HR from below to within the prescribed range in all 3 participants.,"['adults with DD', 'individuals with DD', 'Individuals with Developmental Disabilities Using a Lottery Reinforcement System', '3 adults with DD']","['Teaching High-Intensity Interval Training', 'high-intensity interval training (HIIT']","['Rates of overweight and obesity', 'weight', 'HR', 'Increasing Exercise Intensity', 'heart rate (HR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008073', 'cui_str': 'Developmental disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0269505,Results demonstrated increases in HR from below to within the prescribed range in all 3 participants.,"[{'ForeName': 'Brandon K', 'Initials': 'BK', 'LastName': 'May', 'Affiliation': 'Saint Louis University, St. Louis, MO USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Treadwell', 'Affiliation': 'Elite ABA Services, St. Louis, MO USA.'}]",Behavior analysis in practice,['10.1007/s40617-020-00428-9']
2426,33269114,"Comparative Evaluation of the Effects of Consumption of Colombian Agraz ( Vaccinium meridionale Swartz) on Insulin Resistance, Antioxidant Capacity, and Markers of Oxidation and Inflammation, Between Men and Women with Metabolic Syndrome.","The metabolic syndrome (MS) is a constellation of related factors that increases the risk of developing cardiovascular diseases. Vaccinium meridionale Swartz contains polyphenols that could modulate some components of MS. Epidemiological and intervention studies have shown differences between men and women in MS components and antioxidant capacity. The objective of this study is to compare between men and women with MS the effects of agraz consumption on insulin resistance, antioxidant capacity, and markers of oxidation and inflammation. Men and women diagnosed with MS according to the Adult Treatment Panel III criteria were recruited in a double-blind, crossover study of 12 weeks. Participants were assigned to consume agraz nectar or placebo over 4 weeks. After 4 weeks of washout, they were switched to the alternative treatment. At the end of each period, the components of the MS, insulin resistance, antioxidant capacity, and some oxidative (oxidized low-density lipoprotein [oxLDL]; thiobarbituric acid reactive substances) and inflammatory (high-sensitive C-reactive protein [hs-CRP]) markers were evaluated. After consuming agraz, there was a tendency to increase the levels of antioxidants and to reduce the levels of hs-CRP in both genders. In addition, women who increased their serum phenols after consuming agraz had a significant reduction in insulin resistance, which was different from the results in men. Regarding men, those who increased their serum antioxidant capacity after consuming agraz had a better effect on the reduction of oxLDL levels that was significant compared to women. There are important differences between genders in the effects of agraz consumption in adults with MS.",2020,"After consuming agraz, there was a tendency to increase the levels of antioxidants and to reduce the levels of hs-CRP in both genders.","['Men and Women with Metabolic Syndrome', 'men and women with MS', 'adults with MS', 'Men and women diagnosed with MS according to the Adult Treatment Panel III criteria']","['Consumption of Colombian Agraz ( Vaccinium meridionale Swartz', 'agraz nectar or placebo']","['Insulin Resistance, Antioxidant Capacity, and Markers of Oxidation and Inflammation', 'MS, insulin resistance, antioxidant capacity, and some oxidative (oxidized low-density lipoprotein [oxLDL]; thiobarbituric acid reactive substances) and inflammatory (high-sensitive C-reactive protein [hs-CRP]) markers', 'insulin resistance', 'oxLDL levels', 'levels of hs-CRP', 'levels of antioxidants', 'serum antioxidant capacity', 'insulin resistance, antioxidant capacity, and markers of oxidation and inflammation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0950033', 'cui_str': 'Vaccinium'}, {'cui': 'C2717960', 'cui_str': 'Nectar'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0162781', 'cui_str': 'TBARs'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.0900647,"After consuming agraz, there was a tendency to increase the levels of antioxidants and to reduce the levels of hs-CRP in both genders.","[{'ForeName': 'Yeisson', 'Initials': 'Y', 'LastName': 'Galvis-Pérez', 'Affiliation': 'Research Group of Toxinology, Therapeutic and Food Alternatives, School of Microbiology, Universidad de Antioquia UdeA, Medellín, Colombia.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Marín-Echeverri', 'Affiliation': 'Research Group of Toxinology, Therapeutic and Food Alternatives, School of Microbiology, Universidad de Antioquia UdeA, Medellín, Colombia.'}, {'ForeName': 'Claudia Patricia', 'Initials': 'CP', 'LastName': 'Franco Escobar', 'Affiliation': 'Research Group of Toxinology, Therapeutic and Food Alternatives, School of Microbiology, Universidad de Antioquia UdeA, Medellín, Colombia.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Aristizábal', 'Affiliation': 'Research Group of Physiology and Biochemistry (PHYSIS), School of Nutrition and Dietetics, Universidad de Antioquia UdeA, Medellín, Colombia.'}, {'ForeName': 'Maria-Luz', 'Initials': 'ML', 'LastName': 'Fernández', 'Affiliation': 'Department of Nutritional Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Barona-Acevedo', 'Affiliation': 'Research Group of Toxinology, Therapeutic and Food Alternatives, School of Microbiology, Universidad de Antioquia UdeA, Medellín, Colombia.'}]",BioResearch open access,['10.1089/biores.2020.0053']
2427,33269063,Factors associated with improvement in waist-to-height ratio among newly diagnosed type 2 diabetes patients treated with acarbose or metformin: A randomized clinical trial study.,"BACKGROUND
The waist-to-height ratio (WHtR) is a promising anthropometric measure used to evaluate cardiovascular risk in diabetes and metabolic syndrome patients. The metformin and acarbose in Chinese as the initial hypoglycaemic treatment trial demonstrated that acarbose and metformin reduced the WHtR after 24 wk of treatment.
AIM
To investigate the factors associated with a decrease in the WHtR in newly diagnosed Chinese type 2 diabetes patients receiving acarbose or metformin monotherapy.
METHODS
At 24 wk, 343 patients in the acarbose treatment and 333 patients in the metformin treatment were included in this analysis. On the basis of the reduction in the WHtR, these participants were divided into the following two groups: Low ΔWHtR group and high ΔWHtR group. Metabolic and related parameters associated with a high ΔWHtR were investigated using univariate and multivariate logistic regression analyses.
RESULTS
A significant decrease in the WHtR was observed in both treatment groups (acarbose: -0.015, 95% confidence interval [CI]: -0.018 to -0.012, P < 0.001; metformin: -0.013, 95%CI: -0.016 to -0.010, P < 0.001). In both the acarbose and metformin groups, the WHtR of the women was more likely to be reduced than that of the men. In the acarbose group, a lower baseline area under the curve of glucagon-like peptide 1 (AUCGLP-1) was associated with a high ΔWHtR (odds ratio [OR] = 0.796, P < 0.001), while a higher baseline AUCGLP-1 was associated with a high ΔWHtR in the patients treated with metformin (OR = 1.133, P = 0.025). Regarding the changes from baseline, an increase in AUCGLP-1 was associated with a high ΔWHtR in the acarbose (OR = 1.121, P = 0.016) but not metformin group. A higher reduction in high-density lipoprotein cholesterol/non-high-density lipoprotein cholesterol was also associated with a high ΔWHtR in the acarbose arm (OR = 20.735, P = 0.001). In the metformin arm, a higher reduction in fasting plasma glucose (OR = 0.843, P = 0.039) and total cholesterol was associated with a high ΔWHtR (OR = 0.743, P = 0.013).
CONCLUSION
A lower glucagon-like peptide 1 level and higher increase in glucagon-like peptide 1 are associated with a high reduction in the WHtR in newly diagnosed Chinese diabetes patients receiving treatment with acarbose.",2020,"In the metformin arm, a higher reduction in fasting plasma glucose (OR = 0.843, P = 0.039) and total cholesterol was associated with a high ΔWHtR (OR = 0.743, P = 0.013).
","['343 patients in the acarbose treatment and 333 patients in the', 'newly diagnosed Chinese diabetes patients receiving treatment with', 'diabetes and metabolic syndrome patients', 'newly diagnosed Chinese type 2 diabetes patients receiving acarbose or metformin monotherapy']","['metformin and acarbose', 'acarbose and metformin', 'metformin', 'acarbose or metformin', 'acarbose']","['high-density lipoprotein cholesterol/non-high-density lipoprotein cholesterol', 'waist-to-height ratio', 'curve of glucagon-like peptide 1 (AUCGLP-1', 'WHtR', 'fasting plasma glucose', 'total cholesterol', 'AUCGLP-1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C3871467', 'cui_str': 'metformin and acarbose'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C1821269', 'cui_str': 'Waist to Height Ratio'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",,0.0600556,"In the metformin arm, a higher reduction in fasting plasma glucose (OR = 0.843, P = 0.039) and total cholesterol was associated with a high ΔWHtR (OR = 0.743, P = 0.013).
","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Song', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Zhao-Jun', 'Initials': 'ZJ', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Xiao-Mu', 'Initials': 'XM', 'LastName': 'Kong', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Wen-Ying', 'Initials': 'WY', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China. yangwenying@zryhyy.com.cn.'}]",World journal of diabetes,['10.4239/wjd.v11.i11.514']
2428,33268967,Comparison of two supplemental oxygen methods during gastroscopy with propofol mono-sedation in patients with a normal body mass index.,"BACKGROUND
Hypoxemia due to respiratory depression and airway obstruction during upper gastrointestinal endoscopy with sedation is a common concern. The Wei nasal jet tube (WNJT) is a new nasopharyngeal airway with the ability to provide supraglottic jet ventilation and oxygen insufflation via its built-in wall channel. The available evidence indicates that with a low oxygen flow, compared with nasal cannula, the WNJT does not decrease the occurrence of hypoxemia during upper gastrointestinal endoscopy with propofol sedation. To date, there has been no study assessing the performance of WNJT for supplemental oxygen during upper gastrointestinal endoscopy with sedation when a moderate oxygen flow is used.
AIM
To determine whether the WNJT performs better than the nasal prongs for the prevention of hypoxemia during gastroscopy with propofol mono-sedation when a moderate oxygen flow is provided in patients with a normal body mass index.
METHODS
This study was performed in 291 patients undergoing elective gastroscopy with propofol mono-sedation. Patients were randomized into one of two groups to receive either the WNJT (WNJT group, n = 147) or the nasal cannula (nasal cannula group, n = 144) for supplemental oxygen at a 5-L/min flow during gastroscopy. The lowest SpO 2 during gastroscopy was recorded. The primary endpoint was the incidence of hypoxemia or severe hypoxemia during gastroscopy.
RESULTS
The total incidence of hypoxemia and severe hypoxemia during gastroscopy was significantly decreased in the WNJT group compared with the nasal cannula group ( P = 0.000). The lowest median SpO 2 during gastroscopy was significantly higher (98%; interquartile range, 97-99) in the WNJT group than in the nasal cannula group (96%; interquartile range, 93-98). Epistaxis by device insertion in the WNJT group occurred in 7 patients but stopped naturally without any treatment. The two groups were comparable in terms of the satisfaction of physicians, anesthetists and patients.
CONCLUSION
With a moderate oxygen flow, the WNJT is more effective for the prevention of hypoxemia during gastroscopy with propofol mono-sedation compared with nasal prongs, but causing slight epistaxis in a few patients.",2020,The total incidence of hypoxemia and severe hypoxemia during gastroscopy was significantly decreased in the WNJT group compared with the nasal cannula group ( P = 0.000).,"['291 patients undergoing elective gastroscopy with propofol mono-sedation', 'patients with a normal body mass index']","['Wei nasal jet tube (WNJT', 'moderate oxygen flow', 'propofol mono-sedation', 'WNJT (WNJT group, n = 147) or the nasal cannula (nasal cannula group, n = 144) for supplemental oxygen at a 5-L/min flow during gastroscopy']","['incidence of hypoxemia or severe hypoxemia during gastroscopy', 'occurrence of hypoxemia', 'lowest median SpO 2 during gastroscopy', 'total incidence of hypoxemia and severe hypoxemia during gastroscopy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0336862', 'cui_str': 'Jet airplane'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",291.0,0.0414468,The total incidence of hypoxemia and severe hypoxemia during gastroscopy was significantly decreased in the WNJT group compared with the nasal cannula group ( P = 0.000).,"[{'ForeName': 'Liu-Jia-Zi', 'Initials': 'LJ', 'LastName': 'Shao', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Fu-Kun', 'Initials': 'FK', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wan', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Shao-Hua', 'Initials': 'SH', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Fang-Xiao', 'Initials': 'FX', 'LastName': 'Hong', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.'}, {'ForeName': 'Fu-Shan', 'Initials': 'FS', 'LastName': 'Xue', 'Affiliation': 'Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China. fushanxue@outlook.com.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i43.6867']
2429,32310130,Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial.,"AIMS
The MAGSTEMI trial showed larger endothelium-independent vasodilatation with magnesium-based bioresorbable scaffolds (MgBRS) than with sirolimus-eluting stents (SES). However, restenosis was more frequent with MgBRS. The aims of this study were to compare the healing pattern between MgBRS and SES and to describe the main causes of restenosis, as assessed by optical coherence tomography (OCT).
METHODS AND RESULTS
Ninety-five consecutive patients from the randomised MAGSTEMI trial (MgBRS=48, SES=47) underwent OCT imaging at one year. Healing and bioresorption pattern were categorised into four groups: 1) indiscernible struts were observed in 33.3% versus 0% of patients (p<0.001); 2) struts integrated into the vessel wall in 22.9% versus 63.8% (p<0.001); 3) protruding struts in 37.5% versus 31.9% (p=0.568); and 4) protruding and malapposed struts in 6.3% versus 4.3% (p=0.663), respectively. MgBRS were not suitable for strut coverage analysis; SES presented with 5.6% uncovered struts. Scaffold discontinuities were observed in 10.4% and 0%, respectively (p=0.023). MgBRS presented smaller minimal lumen area (3.92±2.02 vs 6.31±1.71 mm²; p<0.001) and larger area stenosis (52.84±18.05 vs 25.02±14.58%; p<0.001). Scaffold measurements were only feasible in 50% of MgBRS, with the expansion index being smaller than in SES (0.58±0.16 vs 0.86±0.19; p<0.001). Scaffold collapse was observed in at least 50% of cases with MgBRS restenosis.
CONCLUSIONS
Both MgBRS and SES exhibited a low degree of neointima healing, but lumen dimensions were smaller with MgBRS at one year. Although the advanced bioresorption state of MgBRS hampers the assessment of scaffold collapse, this seems to be the main mechanism of restenosis. Future generations of MgBRS should increase and prolong the radial force.
CLINICAL TRIAL REGISTRATION
NCT03234348 Visual summary. Bioresorption and neointima patterns of Mg-based bioresorbabable scaffolds versus permanent sirolimus-eluting stents in STEMI patients at one year.",2020,MgBRS presented smaller minimal lumen area (3.92±2.02 vs 6.31±1.71 mm²; p<0.001) and larger area stenosis (52.84±18.05 vs 25.02±14.58%; p<0.001).,"['patients with ST-segment elevation myocardial infarction', 'STEMI patients at one year', 'Ninety-five consecutive patients']","['permanent sirolimus-eluting stents', 'Bioresorbable scaffolds versus permanent sirolimus-eluting stents', 'sirolimus-eluting stents (SES']","['smaller minimal lumen area', 'MgBRS', 'Bioresorption and neointima patterns', 'neointima healing', 'Healing and bioresorption pattern', 'Scaffold collapse', 'larger area stenosis', 'Scaffold discontinuities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C4517906', 'cui_str': '95'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C2936380', 'cui_str': 'Neointima'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]",95.0,0.0576658,MgBRS presented smaller minimal lumen area (3.92±2.02 vs 6.31±1.71 mm²; p<0.001) and larger area stenosis (52.84±18.05 vs 25.02±14.58%; p<0.001).,"[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Gomez-Lara', 'Affiliation': ""Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortega-Paz', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cuesta', 'Affiliation': ''}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Romaní', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Salinas', 'Affiliation': ''}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'García Del Blanco', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Goicolea', 'Affiliation': ''}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Hernandez-Antolín', 'Affiliation': ''}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Antuña', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Romaguera', 'Affiliation': ''}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Regueiro', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivero', 'Affiliation': ''}, {'ForeName': 'Àngel', 'Initials': 'À', 'LastName': 'Cequier', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': ''}, {'ForeName': 'Joan Antoni', 'Initials': 'JA', 'LastName': 'Gómez-Hospital', 'Affiliation': ''}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00198']
2430,33180322,The LEukemia Artificial Intelligence Program (LEAP) in chronic myeloid leukemia in chronic phase: A model to improve patient outcomes.,"Extreme gradient boosting methods outperform conventional machine-learning models. Here, we have developed the LEukemia Artificial intelligence Program (LEAP) with the extreme gradient boosting decision tree method for the optimal treatment recommendation of tyrosine kinase inhibitors (TKIs) in patients with chronic myeloid leukemia in chronic phase (CML-CP). A cohort of CML-CP patients was randomly divided into training/validation (N = 504) and test cohorts (N = 126). The training/validation cohort was used for 3-fold cross validation to develop the LEAP CML-CP model using 101 variables at diagnosis. The test cohort was then applied to the LEAP CML-CP model and an optimum TKI treatment was suggested for each patient. The area under the curve in the test cohort was 0.81899.Backward multivariate analysis identified age at diagnosis, the degree of comorbidities, and TKI recommended therapy by the LEAP CML-CP model as independent prognostic factors for overall survival. The bootstrapping method internally validated the association of the LEAP CML-CP recommendation with overall survival as an independent prognostic for overall survival. Selecting treatment according to the LEAP CML-CP personalized recommendations, in this model, is associated with better survival probability compared to treatment with a LEAP CML-CP non-recommended therapy. This approach may pave a way of new era of personalized treatment recommendations for patients with cancer.",2020,The bootstrapping method internally validated the association of the LEAP CML-CP recommendation with overall survival as an independent prognostic for overall survival.,"['patients with cancer', 'A cohort of CML-CP patients', 'patients with chronic myeloid leukemia in chronic phase (CML-CP']","['tyrosine kinase inhibitors (TKIs', 'LEukemia Artificial Intelligence Program (LEAP']",['survival probability'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}]","[{'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",504.0,0.0141434,The bootstrapping method internally validated the association of the LEAP CML-CP recommendation with overall survival as an independent prognostic for overall survival.,"[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Elias J', 'Initials': 'EJ', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Konopleva', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Naqvi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Montalban-Bravo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Rashmi', 'Initials': 'R', 'LastName': 'Kanagal-Shamanna', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ghayas', 'Initials': 'G', 'LastName': 'Issa', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Preetesh', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Skinner', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Mary B', 'Initials': 'MB', 'LastName': 'Rios', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pierce', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Soltysiak', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Sato', 'Affiliation': 'Faculty of Medicine, The University of Osaka, Osaka, Japan.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",American journal of hematology,['10.1002/ajh.26047']
2431,33271192,"Letter to the editor: ""A Phase II Randomized Clinical Trial of the Safety and Efficacy of Intravenous Umbilical Cord Blood Infusion for Treatment of Children with Autism Spectrum Disorder"".",,2020,,['Children with Autism Spectrum Disorder'],['Intravenous Umbilical Cord Blood Infusion'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]",[],,0.0771643,,"[{'ForeName': 'Liem Nguyen', 'Initials': 'LN', 'LastName': 'Thanh', 'Affiliation': 'Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam. Electronic address: v.liemnt@vinmec.com.'}, {'ForeName': 'Phuong H', 'Initials': 'PH', 'LastName': 'Nguyen', 'Affiliation': 'Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.'}, {'ForeName': 'Duc M', 'Initials': 'DM', 'LastName': 'Hoang', 'Affiliation': 'Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.11.063']
2432,33271178,Preoperative intraligamentary injection of dexamethasone can improve the anesthetic success rate of 2% lidocaine during the endodontic management of mandibular molars with symptomatic irreversible pulpitis.,"INTRODUCTION
This randomized, double-blind clinical trial aimed at the evaluation of the effect of preoperative administration of intraligamentary injections of diclofenac sodium and dexamethasone on the anesthetic efficacy of 2% lidocaine, given as inferior alveolar nerve block in the endodontic management of symptomatic irreversible pulpitis.
MATERIALS AND METHODS
One-hundred-seventeen patients randomly received one of the three intraligamentary injections before the endodontic treatment: 0.9% normal saline, 25mg/mL diclofenac sodium, or 4mg/mL dexamethasone. After 30 minutes, patients received an inferior alveolar nerve block with 2% lidocaine and 1:80 000 epinephrine. The teeth were tested with electric pulp testing after 10 minutes. In case of a positive response, the anesthesia was considered as 'failed'. If the electric test response was negative, a rubber dam was applied and endodontic treatment was started. Any pain during the treatment was recorded. The anesthetia was considered successful if the patients experienced no pain or faint/weak/mild pain during root canal access preparation and instrumentation (HP VAS score <55 mm). The effect of intraligamentary injections on maximum heart rates was also recorded. The anesthetic success rates were analyzed with the Pearson chi-square test at 5% significance.
RESULTS
The control group, diclofenac sodium, and dexamethasone group gave anesthetic success rates of 32%, 37%, and 73% respectively. Dexamethasone was significantly more successful than the control and diclofenac sodium group (p<<0.001, χ 2 = 14.7, df =2). There were no differences between the control and diclofenac groups (p>0.05). All the solutions did not significantly affect the heart rates.
CONCLUSIONS
Administration of an intraligamentary injection of dexamethasone beforethe endodontic intervention of mandibular molars with symptomatic irreversible pulpitis increases the success rates of an inferior alveolar nerve block with 2% lidocaine.",2020,"Dexamethasone was significantly more successful than the control and diclofenac sodium group (p<<0.001, χ 2 = 14.7, df =2).","['One-hundred-seventeen patients', 'symptomatic irreversible pulpitis', 'mandibular molars with symptomatic irreversible pulpitis']","['diclofenac', 'endodontic treatment: 0.9% normal saline, 25mg/mL diclofenac sodium, or 4mg/mL dexamethasone', 'inferior alveolar nerve block with 2% lidocaine', 'diclofenac sodium, and dexamethasone', 'epinephrine', 'lidocaine', 'Dexamethasone', 'diclofenac sodium and dexamethasone', 'dexamethasone', 'diclofenac sodium', 'intraligamentary injections']","['maximum heart rates', 'anesthetic efficacy', 'anesthetic success rates', 'anesthetic success rate', 'heart rates']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C0700632', 'cui_str': 'Endodontic procedure'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",117.0,0.193312,"Dexamethasone was significantly more successful than the control and diclofenac sodium group (p<<0.001, χ 2 = 14.7, df =2).","[{'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Aggarwal', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India. Electronic address: drvivekaggarwal@gmail.com.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Singla', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, SGT Dental College, Gurgaon, Haryana, India.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Saatchi', 'Affiliation': 'Professor of Endodontics, School of Dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Alpa', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Manav Rachna Dental College, Faridabaad, India.'}, {'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Hasija', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India.'}, {'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Meena', 'Affiliation': 'Department of Conservative Dentistry & Endodontics, Faculty of Dentistry, Jamia Millia Islamia, New Delhi, India.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Division of Conservative Dentistry and Endodontics, Post Graduate Institute of Medical Sciences, Chandigarh, India.'}]",Journal of endodontics,['10.1016/j.joen.2020.11.023']
2433,33271095,"Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial.","BACKGROUND
Gemogenovatucel-T is an autologous tumour cell vaccine manufactured from harvested tumour tissue, which specifically reduces expression of furin and downstream TGF-β1 and TGF-β2. The aim of this study was to determine the safety and efficacy of gemogenovatucel-T in front-line ovarian cancer maintenance.
METHODS
This randomised, double-blind, placebo-controlled, phase 2b trial involved 25 hospitals in the USA. Women aged 18 years and older with stage III/IV high-grade serous, endometrioid, or clear cell ovarian cancer in clinical complete response after a combination of surgery and five to eight cycles of chemotherapy involving carboplatin and paclitaxel, and an Eastern Cooperative Oncology Group status of 0 or 1 were eligible for inclusion in the study. Patients were randomly assigned (1:1) to gemogenovatucel-T or placebo by an independent third party interactive response system after successful screening using randomly permuted block sizes of two and four and stratified by extent of surgical cytoreduction and neoadjuvant versus adjuvant chemotherapy. Gemogenovatucel-T (1 × 10 7 cells per injection) or placebo was administered intradermally (one per month) for a minimum of four and up to 12 doses. Patients, investigators, and clinical staff were masked to patient allocation until after statistical analysis. The primary endpoint was recurrence-free survival, analysed in the per-protocol population. All patients who received at least one dose of gemogenovatucel-T were included in the safety analysis. The study is registered with ClinicalTrials.gov, NCT02346747.
FINDINGS
Between Feb 11, 2015, and March 2, 2017, 310 patients consented to the study at 22 sites. 217 were excluded. 91 patients received gemogenovatucel-T (n=47) or placebo (n=44) and were analysed for safety and efficacy. The median follow-up from first dose of gemogenovatucel-T was 40·0 months (IQR 35·0-44·8) and from first dose of placebo was 39·8 months (35·5-44·6). Recurrence-free survival was 11·5 months (95% CI 7·5-not reached) for patients assigned to gemogenovatucel-T versus 8·4 months (7·9-15·5) for patients assigned to placebo (HR 0·69, 90% CI 0·44-1·07; one-sided p=0·078). Gemogenovatucel-T resulted in no grade 3 or 4 toxic effects. Two patients in the placebo group had five grade 3 toxic events, including arthralgia, bone pain, generalised muscle weakness, syncope, and dyspnea. Seven patients (four in the placebo group and three in the gemogenovatucel-T group) had 11 serious adverse events. No treatment-related deaths were reported in either of the groups.
INTERPRETATION
Front-line use of gemogenovatucel-T immunotherapy as maintenance was well tolerated but the primary endpoint was not met. Further investigation of gemogenovatucel-T in patients stratified by BRCA mutation status is warranted.
FUNDING
Gradalis.",2020,Recurrence-free survival was 11·5 months (95% CI 7·5-not reached) for patients assigned to gemogenovatucel-T versus 8·4 months (7·9-15·5) for patients assigned to placebo (,"['310 patients consented to the study at 22 sites', 'frontline stage III/IV ovarian cancer', 'Between Feb 11, 2015, and March 2, 2017', 'All patients who received at least one dose of gemogenovatucel-T were included in the safety analysis', '91 patients received', 'Women aged 18 years and older with stage III/IV high-grade serous, endometrioid, or clear cell ovarian cancer', ' and an Eastern Cooperative Oncology Group status of 0 or 1 were eligible for inclusion in the study', '25 hospitals in the USA']","['surgical cytoreduction and neoadjuvant versus adjuvant chemotherapy', 'gemogenovatucel-T or placebo', 'placebo', 'placebo ', 'Gemogenovatucel-T (Vigil) immunotherapy', 'chemotherapy involving carboplatin and paclitaxel', 'gemogenovatucel-T']","['serious adverse events', 'Recurrence-free survival', 'safety and efficacy', 'five grade 3 toxic events, including arthralgia, bone pain, generalised muscle weakness, syncope, and dyspnea', 'recurrence-free survival']","[{'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0151825', 'cui_str': 'Bone pain'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]",25.0,0.781293,Recurrence-free survival was 11·5 months (95% CI 7·5-not reached) for patients assigned to gemogenovatucel-T versus 8·4 months (7·9-15·5) for patients assigned to placebo (,"[{'ForeName': 'Rodney P', 'Initials': 'RP', 'LastName': 'Rocconi', 'Affiliation': 'Division of Gynecologic Oncology, University of South Alabama-Mitchell Cancer Institute, Mobile, AL, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Grosen', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Care Northwest, Spokane, WA, USA.'}, {'ForeName': 'Sharad A', 'Initials': 'SA', 'LastName': 'Ghamande', 'Affiliation': 'Section of Gynecologic Oncology, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Chan', 'Affiliation': 'Division of Gynecologic Oncology, California Pacific/Palo Alto Medical Foundation, Sutter Center Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Minal A', 'Initials': 'MA', 'LastName': 'Barve', 'Affiliation': 'Department of Oncology, Mary Crowley Cancer Research Centers, Dallas, TX, USA; Department of Oncology, Texas Oncology, Dallas, TX, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Department of Oncology, Texas Oncology, Dallas, TX, USA.'}, {'ForeName': 'Devansu', 'Initials': 'D', 'LastName': 'Tewari', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, Irvine, CA, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Morris', 'Affiliation': 'Division of Gynecologic Oncology, Nebraska Methodist Hospital, Omaha, NE, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Stevens', 'Affiliation': 'Department of Gynecologic Oncology, Billings Clinic, Billings, MT, USA.'}, {'ForeName': 'Justin N', 'Initials': 'JN', 'LastName': 'Bottsford-Miller', 'Affiliation': 'Department of Gynecologic Oncology, Billings Clinic, Billings, MT, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Stats Department, StatBeyond Consulting, Irvine, CA, USA.'}, {'ForeName': 'Phylicia', 'Initials': 'P', 'LastName': 'Aaron', 'Affiliation': 'Department of Medical Affairs, Gradalis, Carollton, TX, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Stanbery', 'Affiliation': 'Department of Medical Affairs, Gradalis, Carollton, TX, USA.'}, {'ForeName': 'Staci', 'Initials': 'S', 'LastName': 'Horvath', 'Affiliation': 'Department of Site Research, Gradalis, Carollton, TX, USA.'}, {'ForeName': 'Gladice', 'Initials': 'G', 'LastName': 'Wallraven', 'Affiliation': 'Department of Clinical and Regulatory Operations, Gradalis, Carollton, TX, USA.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Bognar', 'Affiliation': 'Department of CMC Operations, Gradalis, Carollton, TX, USA; Department of CMC Operations, Gradalis, Carollton, TX, USA; Department of CMC Operations, Gradalis, Carollton, TX, USA.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': 'Department of Medical Affairs, Gradalis, Carollton, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nemunaitis', 'Affiliation': 'Department of Medical Affairs, Gradalis, Carollton, TX, USA. Electronic address: jnemunaitis@gradalisinc.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shanahan', 'Affiliation': 'Management Department, Gradalis, Carollton, TX, USA; Management Department, Gradalis, Carollton, TX, USA; Management Department, Gradalis, Carollton, TX, USA.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Slomovitz', 'Affiliation': 'Department of Obstetrics and Gynecology, Broward Health, Fort Lauderdale, FL, USA; Department of Obstetrics and Gynecology, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Cincinnati Cancer Center, Cincinnati, OH, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Department of Obstetrics and Gynecology, Arizona Oncology, Phoenix, AZ, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'US Oncology Research, The Woodlands, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30533-7']
2434,33271094,"Pembrolizumab plus GX-188E therapeutic DNA vaccine in patients with HPV-16-positive or HPV-18-positive advanced cervical cancer: interim results of a single-arm, phase 2 trial.","BACKGROUND
Survival outcomes for patients with recurrent or advanced cervical cancer are poor. Pembrolizumab has been approved for the treatment of recurrent or metastatic cervical cancer, with an overall response rate of 14·3%. GX-188E vaccination has been shown to induce human papillomavirus (HPV) E6-specific and E7-specific T-cell responses and cervical lesion regression in patients with cervical precancer. We aimed to investigate whether a combination of GX-188E therapeutic DNA vaccine plus pembrolizumab showed antitumour activity against recurrent or advanced cervical cancer.
METHODS
In this open-label, single-arm, phase 2 trial, patients with recurrent or advanced, inoperable cervical cancer, who were aged 18 years or older with Eastern Cooperative Oncology Group performance status of 0 or 1 and histologically confirmed recurrent or advanced HPV-positive (HPV-16 or HPV-18) cervical cancer, and who had progressed after available standard-of-care therapy were recruited from seven hospitals in South Korea. Patients received intramuscular 2 mg GX-188E at weeks 1, 2, 4, 7, 13, and 19, with one optional dose at week 46 that was at the investigator's discretion, and intravenous pembrolizumab 200 mg every 3 weeks for up to 2 years or until disease progression. The primary endpoint was the overall response rate within 24 weeks assessed by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 in patients who received at least 45 days of treatment 45 days of treatment with at least one post-baseline tumour assessment, and this is the report of a planned interim analysis. This trial is registered with ClinicalTrials.gov, NCT03444376.
FINDINGS
Between June 19, 2018, and March 20, 2020, 36 patients were enrolled and received at least one dose of the study treatment. 26 patients were evaluable for interim activity assessment, with at least one post-baseline tumour assessment at week 10. At the data cutoff date on March 30, 2020, median follow-up duration was 6·2 months (IQR 3·5-8·1). At 24 weeks, 11 (42%; 95% CI 23-63) of 26 patients achieved an overall response; four (15%) had a complete response and seven (27%) had a partial response. 16 (44%) of 36 patients had treatment-related adverse events of any grade and four (11%) had grade 3-4 treatment-related adverse events. Grade 3 increased aspartate aminotransferase, syncope, pericardial effusion, and hyperkalaemia, and grade 4 increased alanine aminotransferase were reported in one patient each. No treatment-related deaths were reported.
INTERPRETATION
Treatment with GX-188E therapeutic vaccine plus pembrolizumab for patients with recurrent or advanced cervical cancer was safe and treatment-related adverse events were manageable. This combination therapy showed preliminary antitumour activity in this interim analysis, which could represent a new potential treatment option for this patient population. This trial is ongoing.
FUNDING
National OncoVenture.",2020,"At 24 weeks, 11 (42%; 95% CI 23-63) of 26 patients achieved an overall response; four (15%) had a complete response and seven (27%) had a partial response.","['patients with recurrent or advanced cervical cancer', 'Between June 19, 2018, and March 20, 2020, 36 patients were enrolled and received at least one dose of the study treatment', 'patients with HPV-16-positive or HPV-18-positive advanced cervical cancer', '26 patients were evaluable for interim activity assessment, with at least one post-baseline tumour assessment at week 10', 'patients with cervical precancer', 'patients with recurrent or advanced, inoperable cervical cancer, who were aged 18 years or older with Eastern Cooperative Oncology Group performance status of 0 or 1 and histologically confirmed recurrent or advanced HPV-positive (HPV-16 or HPV-18) cervical cancer, and who had progressed after available standard-of-care therapy were recruited from seven hospitals in South Korea']","['Pembrolizumab', 'GX-188E vaccination', 'intramuscular 2 mg GX-188E', 'GX-188E therapeutic DNA vaccine plus pembrolizumab', 'pembrolizumab', 'GX-188E therapeutic vaccine plus pembrolizumab', 'Pembrolizumab plus GX-188E therapeutic DNA vaccine']","['antitumour activity against recurrent or advanced cervical cancer', 'overall response rate', 'overall response', 'aspartate aminotransferase, syncope, pericardial effusion, and hyperkalaemia, and grade 4 increased alanine aminotransferase', 'partial response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0999806', 'cui_str': 'Human papillomavirus, type 16'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0999807', 'cui_str': 'Human papillomavirus, type 18'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0007868', 'cui_str': 'Dysplasia of cervix'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376613', 'cui_str': 'DNA Vaccines'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042210', 'cui_str': 'Vaccine'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0031039', 'cui_str': 'Pericardial effusion'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",26.0,0.316898,"At 24 weeks, 11 (42%; 95% CI 23-63) of 26 patients achieved an overall response; four (15%) had a complete response and seven (27%) had a partial response.","[{'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Youn', 'Affiliation': 'Genexine, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Soo-Young', 'Initials': 'SY', 'LastName': 'Hur', 'Affiliation': ""The Catholic University of Korea, Seoul St Mary's Hospital, Seocho-gu, Seoul, South Korea.""}, {'ForeName': 'Jung Won', 'Initials': 'JW', 'LastName': 'Woo', 'Affiliation': 'Genexine, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Yong-Man', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Songpa-gu, Seoul, South Korea.'}, {'ForeName': 'Myong Cheol', 'Initials': 'MC', 'LastName': 'Lim', 'Affiliation': 'National Cancer Center, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sang Yoon', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sang Soo', 'Initials': 'SS', 'LastName': 'Seo', 'Affiliation': 'National Cancer Center, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Jae Hong', 'Initials': 'JH', 'LastName': 'No', 'Affiliation': 'Seoul National University Bundang Hospital, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Byoung-Gie', 'Initials': 'BG', 'LastName': 'Kim', 'Affiliation': 'Samsung Medical Center, Gangnam-gu, Seoul, South Korea.'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Korea University Guro Hospital, Guro-gu, Seoul, South Korea.'}, {'ForeName': 'So Jin', 'Initials': 'SJ', 'LastName': 'Shin', 'Affiliation': 'Keimyung University Dongsan Medical Center, Dalseo-gu, Daegu, South Korea.'}, {'ForeName': 'Kyungun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'National Onco Venture, Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Marya F', 'Initials': 'MF', 'LastName': 'Chaney', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Yoon-Jeong', 'Initials': 'YJ', 'LastName': 'Choi', 'Affiliation': 'Genexine, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'You Suk', 'Initials': 'YS', 'LastName': 'Suh', 'Affiliation': 'Genexine, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Jong Sup', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Genexine, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea.'}, {'ForeName': 'Young Chul', 'Initials': 'YC', 'LastName': 'Sung', 'Affiliation': 'Genexine, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea; Pohang University of Science and Technology, Pohang, Gyeongbuk, South Korea. Electronic address: ycsung@genexine.com.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30486-1']
2435,33271093,Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial.,"BACKGROUND
Oncogenic human papillomavirus (HPV) infections cause most cases of cervical cancer. Here, we report long-term follow-up results for the Costa Rica Vaccine Trial (publicly funded and initiated before licensure of the HPV vaccines), with the aim of assessing the efficacy of the bivalent HPV vaccine for preventing HPV 16/18-associated cervical intraepithelial neoplasia grade 2 or worse (CIN2+).
METHODS
Women aged 18-25 years were enrolled in a randomised, double-blind, controlled trial in Costa Rica, between June 28, 2004, and Dec 21, 2005, designed to assess the efficacy of a bivalent vaccine for the prevention of infection with HPV 16/18 and associated precancerous lesions at the cervix. Participants were randomly assigned (1:1) to receive an HPV 16/18 AS04-adjuvanted vaccine or control hepatitis A vaccine. Vaccines were administered intramuscularly in three 0·5 mL doses at 0, 1, and 6 months and participants were followed up annually for 4 years. After the blinded phase, women in the HPV vaccine group were invited to enrol in the long-term follow-up study, which extended follow-up for 7 additional years. The control group received HPV vaccine and was replaced with a new unvaccinated control group. Women were followed up every 2 years until year 11. Investigators and patients were aware of treatment allocation for the follow-up phase. At each visit, clinicians collected cervical cells from sexually active women for cytology and HPV testing. Women with abnormal cytology were referred to colposcopy, biopsy, and treatment as needed. Women with negative results at the last screening visit (year 11) exited the long-term follow-up study. The analytical cohort for vaccine efficacy included women who were HPV 16/18 DNA-negative at vaccination. The primary outcome of this analysis was defined as histopathologically confirmed CIN2+ or cervical intraepithelial neoplasia grade 3 or worse associated with HPV 16/18 cervical infection detected at colposcopy referral. We calculated vaccine efficacy by year and cumulatively. This long-term follow-up study is registered with ClinicalTrials.gov, NCT00867464.
FINDINGS
7466 women were enrolled in the Costa Rica Vaccine Trial; 3727 received the HPV vaccine and 3739 received the control vaccine. Between March 30, 2009, and July 5, 2012, 2635 women in the HPV vaccine group and 2836 women in the new unvaccinated control group were enrolled in the long-term follow-up study. 2635 women in the HPV vaccine group and 2677 women in the control group were included in the analysis cohort for years 0-4, and 2073 women from the HPV vaccine group and 2530 women from the new unvaccinated control group were included in the analysis cohort for years 7-11. Median follow-up time for the HPV group was 11·1 years (IQR 9·1-11·7), 4·6 years (4·3-5·3) for the original control group, and 6·2 years (5·5-6·9) for the new unvaccinated control group. At year 11, vaccine efficacy against incident HPV 16/18-associated CIN2+ was 100% (95% CI 89·2-100·0); 34 (1·5%) of 2233 unvaccinated women had a CIN2+ outcome compared with none of 1913 women in the HPV group. Cumulative vaccine efficacy against HPV 16/18-associated CIN2+ over the 11-year period was 97·4% (95% CI 88·0-99·6). Similar protection was observed against HPV 16/18-associated CIN3-specifically at year 11, vaccine efficacy was 100% (95% CI 78·8-100·0) and cumulative vaccine efficacy was 94·9% (73·7-99·4). During the long-term follow-up, no serious adverse events occurred that were deemed related to the HPV vaccine. The most common grade 3 or worse serious adverse events were pregnancy, puerperium, and perinatal conditions (in 255 [10%] of 2530 women in the unvaccinated control group and 201 [10%] of 2073 women in the HPV vaccine group). Four women in the unvaccinated control group and three in the HPV vaccine group died; no deaths were deemed to be related to the HPV vaccine.
INTERPRETATION
The bivalent HPV vaccine has high efficacy against HPV 16/18-associated precancer for more than a decade after initial vaccination, supporting the notion that invasive cervical cancer is preventable.
FUNDING
US National Cancer Institute.",2020,"Four women in the unvaccinated control group and three in the HPV vaccine group died; no deaths were deemed to be related to the HPV vaccine.
","['HPV 16/18-associated cervical intraepithelial neoplasia grade 2 or worse (CIN2', 'Women with negative results at the last screening visit (year 11) exited the long-term follow-up study', 'women who were HPV 16/18 DNA-negative at vaccination', 'Between March 30, 2009, and July 5, 2012, 2635 women in the HPV vaccine group and 2836 women in the new unvaccinated control group were enrolled in the long-term follow-up study', 'Oncogenic human papillomavirus (HPV) infections', '2635 women in the HPV vaccine group and 2677 women in the control group were included in the analysis cohort for years 0-4, and 2073 women from the HPV vaccine group and 2530 women from the new unvaccinated control group were included in the analysis cohort for years 7-11', 'Women aged 18-25 years', 'Women with abnormal cytology', '7466 women were enrolled in the Costa Rica Vaccine Trial; 3727 received the']","['HPV 16/18 AS04-adjuvanted vaccine or control hepatitis A vaccine', 'bivalent HPV vaccine', 'HPV vaccine', 'control vaccine']","['vaccine efficacy', 'serious adverse events', 'histopathologically confirmed CIN2+ or cervical intraepithelial neoplasia grade 3 or worse associated with HPV 16/18 cervical infection detected at colposcopy referral', 'Cumulative vaccine efficacy', 'vaccine efficacy against incident HPV 16/18-associated CIN2', 'pregnancy, puerperium, and perinatal conditions', 'cumulative vaccine efficacy']","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4704700', 'cui_str': 'Null Results'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0010182', 'cui_str': 'Costa Rica'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}, {'cui': 'C1721788', 'cui_str': 'human papillomavirus vaccine, L1 type 16, 18'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0349459', 'cui_str': 'Cervical intraepithelial neoplasia grade 2'}, {'cui': 'C0851140', 'cui_str': 'Carcinoma in situ of uterine cervix'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0851363', 'cui_str': 'Pregnancy, puerperium and perinatal conditions'}]",7466.0,0.283974,"Four women in the unvaccinated control group and three in the HPV vaccine group died; no deaths were deemed to be related to the HPV vaccine.
","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, San José, Costa Rica. Electronic address: cporras@acibcr.com.'}, {'ForeName': 'Sabrina H', 'Initials': 'SH', 'LastName': 'Tsang', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, San José, Costa Rica; Early Detection and Prevention Section, International Agency for Research on Cancer, World Health Organization, Lyon, France.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Guillén', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Darragh', 'Affiliation': 'University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Stoler', 'Affiliation': 'Department of Pathology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hildesheim', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wagner', 'Affiliation': 'Cancer Genomics Research Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Boland', 'Affiliation': 'Cancer Genomics Research Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Frederick, MD, USA.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Lowy', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schiller', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schiffman', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schussler', 'Affiliation': 'Information Management Services, Calverton, MD, USA.'}, {'ForeName': 'Mitchell H', 'Initials': 'MH', 'LastName': 'Gail', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Quint', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, Netherlands.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Ocampo', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Morales', 'Affiliation': 'Agencia Costarricense de Investigaciones Biomédicas, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Ana C', 'Initials': 'AC', 'LastName': 'Rodríguez', 'Affiliation': 'San José, Costa Rica.'}, {'ForeName': 'Shangying', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Aimée R', 'Initials': 'AR', 'LastName': 'Kreimer', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30524-6']
2436,33271092,"Effect of duration of adjuvant chemotherapy for patients with stage III colon cancer (IDEA collaboration): final results from a prospective, pooled analysis of six randomised, phase 3 trials.","BACKGROUND
A prospective, pooled analysis of six randomised phase 3 trials was done to investigate disease-free survival regarding non-inferiority of 3 months versus 6 months of adjuvant chemotherapy for patients with stage III colon cancer; non-inferiority was not shown. Here, we report the final overall survival results.
METHODS
In this prospective, pooled analysis of six randomised phase 3 trials, we included patients with stage III colon cancer aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-1 recruited between June 20, 2007, and Dec 31, 2015, across 12 countries in the CALGB/SWOG 80702, IDEA France, SCOT, ACHIEVE, TOSCA, and HORG trials, who started any treatment (modified intention-to-treat). Patients in all trials were randomly assigned to 3 months or 6 months of adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) every 2 weeks or capecitabine and oxaliplatin (CAPOX) in different doses and methods every 3 weeks, at the treating physician's discretion. The primary endpoint was disease-free survival (time to relapse, secondary colorectal primary tumour, or death due to all causes), and overall survival (time to death due to all causes) was the prespecified secondary endpoint. The non-inferiority margin for overall survival was set as a hazard ratio (HR) of 1·11. Pre-planned subgroup analyses included regimen and risk group. Non-inferiority was declared if the one-sided false discovery rate adjusted (FDRadj) p value was less than 0·025.
FINDINGS
With median follow-up of 72·3 months (IQR 72·2-72·5), 2584 deaths among 12 835 patients were observed. 5064 (39·5%) patients received CAPOX and 7771 (60·5%) received FOLFOX. 5-year overall survival was 82·4% (95% CI 81·4-83·3) with 3 months of therapy and 82·8% (81·8-83·8) with 6 months of therapy (HR 1·02 [95% CI 0·95-1·11]; non-inferiority FDRadj p=0·058). For patients treated with CAPOX, 5-year overall survival was 82·1% (80·5-83·6) versus 81·2% (79·2-82·9; HR 0·96 [0·85-1·08]); non-inferiority FDRadj p=0·033), and for patients treated with FOLFOX 5-year overall survival was 82·6% (81·3-83·8) and 83·8% (82·6-85·0; HR 1·07 [0·97-1·18]; non-inferiority FDRadj p=0·34). Updated disease-free survival results confirmed previous findings (HR 1·08 [95% CI 1·02-1·15]; non-inferiority FDRadj p=0·25). Data on adverse events were not further recorded.
INTERPRETATION
Non-inferiority of 3 months versus 6 months of adjuvant chemotherapy for patients with stage III colon cancer was not confirmed in terms of overall survival, but the absolute 0·4% difference in 5-year overall survival should be placed in clinical context. Overall survival results support the use of 3 months of adjuvant CAPOX for most patients with stage III colon cancer. This conclusion is strengthened by the substantial reduction of toxicities, inconveniencies, and cost associated with a shorter treatment duration.
FUNDING
US National Cancer Institute.",2020,Updated disease-free survival results confirmed previous findings (HR 1·08 [95% CI 1·02-1·15]; non-inferiority FDRadj p=0·25).,"['patients with stage III colon cancer', 'patients with stage III colon cancer aged at least 18 years with an Eastern Cooperative Oncology Group performance status of 0-1 recruited between June 20, 2007, and Dec 31, 2015, across 12 countries in the CALGB/SWOG 80702, IDEA France, SCOT, ACHIEVE, TOSCA, and HORG trials, who started any treatment (modified intention-to-treat', 'patients with stage III colon cancer (IDEA collaboration', 'patients with stage']","['CAPOX', 'FOLFOX. 5-year', 'adjuvant chemotherapy', 'adjuvant fluorouracil, leucovorin, and oxaliplatin (FOLFOX) every 2 weeks or capecitabine and oxaliplatin (CAPOX', 'adjuvant CAPOX']","['5-year overall survival', 'FOLFOX 5-year overall survival', 'adverse events', 'disease-free survival (time to relapse, secondary colorectal primary tumour, or death due to all causes), and overall survival (time to death', 'Overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278480', 'cui_str': 'Carcinoma of colon, stage III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]",1.0,0.631,Updated disease-free survival results confirmed previous findings (HR 1·08 [95% CI 1·02-1·15]; non-inferiority FDRadj p=0·25).,"[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': 'Sorbonne Université and Hôpital Saint Antoine, Paris, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Meyerhardt', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Iveson', 'Affiliation': 'Department of Medical Oncology, University of Southampton, Southampton, UK.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Medical Oncology Unit, Ospedale San Martino, Genova, Italy.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': 'Department of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Souglakos', 'Affiliation': 'Department of Medical Oncology, University Hospital of Heraklion, Heraklion, Greece.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'West Cancer Center and Research Institute, OneOncology, Germantown, TN, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Saunders', 'Affiliation': 'Christie Hospital, Manchester, UK.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Ospdale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Yokohama City University School of Medicine Yokohama, Japan.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Boukovinas', 'Affiliation': 'Bioclinic Thessaloniki Medical Oncology Unit, Thessaloniki, Greece.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'Vernerey', 'Affiliation': 'Methodology and Quality of Life Unit, INSERM UMR 1098, Besançon, France.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Meyers', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Harkin', 'Affiliation': 'Operations Director, Cancer Research UK Glasgow Clinical Trials Unit, Glasgow, UK.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Torri', 'Affiliation': 'IRRCS Mario Negri Institute for Pharmacological Research, Milan, Italy.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Georgoulias', 'Affiliation': 'University of Crete, Rethymnon, Greece.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Taieb', 'Affiliation': 'Université de Paris and Department of Gastroenterology and Gastrointestinal Oncology, Georges-Pompidou European Hospital, Paris, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Shields', 'Affiliation': 'Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Shi', 'Affiliation': 'Department of Health Science Research, Mayo Clinic, Rochester, MN, USA. Electronic address: shi.qian2@mayo.edu.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30527-1']
2437,33271042,Assessing mindfulness: Experimental support for the discriminant validity of breath counting as a measure of mindfulness but not self-report questionnaires.,"The current study sought to examine the discriminant validity of 3 commonly used measures of mindfulness. The discriminative ability of the Mindful Attention Awareness Scale (MAAS), the Five Factor Mindfulness Questionnaire (FFMQ), and a breath counting task (BCT) was assessed in a randomized control trial involving an 8-week mindfulness training (MT) condition (n = 53) and an active control computerized attention training (CT) program (n = 33). No evidence to support the discriminant validity of MAAS or FFMQ scores was found, as these self-report measures responded to both the MT and CT conditions. Breath counting scores however demonstrated unique responsiveness to the MT program, suggesting this behavioral task may be useful in measuring changes in mindfulness as it closely resembles core cognitive processes trained during this practice. Implications of these findings for the construct validity of both self-report and behavioral measures of mindfulness are discussed, along with the suitability of current mindfulness-based interventions in studies aiming to assess mindfulness outcomes. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"No evidence to support the discriminant validity of MAAS or FFMQ scores was found, as these self-report measures responded to both the MT and CT conditions.",[],['8-week mindfulness training (MT) condition (n = 53) and an active control computerized attention training (CT) program'],"['discriminative ability of the Mindful Attention Awareness Scale (MAAS), the Five Factor Mindfulness Questionnaire (FFMQ), and a breath counting task (BCT', 'MAAS or FFMQ scores']",[],"[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0139315,"No evidence to support the discriminant validity of MAAS or FFMQ scores was found, as these self-report measures responded to both the MT and CT conditions.","[{'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Isbel', 'Affiliation': 'Thompson Institute.'}, {'ForeName': 'Kayla', 'Initials': 'K', 'LastName': 'Stefanidis', 'Affiliation': 'Thompson Institute.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Summers', 'Affiliation': 'School of Social Sciences (Psychology).'}]",Psychological assessment,['10.1037/pas0000957']
2438,33271000,Informed consent in critically ill adults participating to a randomized trial.,"OBJECTIVE
The 2014 update of the Swiss law on research increases patients' protection; it adds specific requirements for emergency situations, implying an active search for patients' wishes regarding research participation; the possibility of consent waivers is not clearly stated. We explored its practical impact in a RCT on critically ill adults.
METHODS
We considered prospectively collected consents of a multicenter trial addressing the impact of continuous EEG on survival. We assessed the proportions of consents obtained strictly according to the law, of specific waivers for this study obtained from the IRB (early death; relatives' unavailability despite repeated attempts), and the yield of retrieving statements on willingness to research participation. We compared the proportion of consent refusals with those of recent trials in similar environments, and estimated the potential impact on study results.
RESULTS
Of 402 recruited patients, six had double inclusions, one died before intervention, and 27 (6.7%, alive on long-term) were excluded following consent refusal or withdrawal, leaving 368 analyzable patients. Specific waivers allowed inclusion of 134 (36.4%) patients, while informed consents were obtained for all others. A statement of willingness to research participation was found in only 14.1%. In recent trials, consent refusal oscillated between 0%-23%, according to different waiver policies.
CONCLUSIONS
Consent waivers should be specifically foreseen to prevent losing a potentially relevant proportion of patients reaching endpoints, and ensure results generalizability. The yield of looking for willingness to research participation seems low; this questions its current usefulness and calls for a public awareness campaign.",2020,"RESULTS
Of 402 recruited patients","['critically ill adults', 'critically ill adults participating', '402 recruited patients']",[],['survival'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0038952', 'cui_str': 'Survival'}]",402.0,0.101451,"RESULTS
Of 402 recruited patients","[{'ForeName': 'Milène', 'Initials': 'M', 'LastName': 'Guinchard', 'Affiliation': 'Department of Clinical Neuroscience, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Loane', 'Initials': 'L', 'LastName': 'Warpelin-Decrausaz', 'Affiliation': 'Clinical Trial Unit, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Schindler', 'Affiliation': 'Sleep-Wake-Epilepsy-Center, Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Rüegg', 'Affiliation': 'Department of Neurology, University Hospital Basel and University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Oddo', 'Affiliation': 'Department of Intensive Care Medicine, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Novy', 'Affiliation': 'Department of Clinical Neuroscience, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Alvarez', 'Affiliation': 'Department of Clinical Neuroscience, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Andrea O', 'Initials': 'AO', 'LastName': 'Rossetti', 'Affiliation': 'Department of Clinical Neuroscience, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.'}]",Brain and behavior,['10.1002/brb3.1965']
2439,33270945,"Preliminary evidence for an association between intake of high-fat high-sugar diet, variations in peripheral dopamine precursor availability and dopamine-dependent cognition in humans.","Obesity is associated with alterations in dopaminergic transmission and cognitive function. Rodent studies suggest that diets rich in saturated fat and refined sugars (HFS), as opposed to diets diets low in saturated fat and refined sugars (LFS), change the dopamine system independent of excessive body weight. However, the impact of HFS on the human brain has not been investigated. Here, we compared the effect of dietary dopamine depletion on dopamine-dependent cognitive task performance between two groups differing in habitual intake of dietary fat and sugar. Specifically, we used a double-blind within-subject cross-over design to compare the effect of acute phenylalanine/tyrosine depletion on a reinforcement learning and a working memory task, in two groups that are on opposite ends of the spectrum of self-reported HFS intake (low vs high intake: LFS vs HFS group). We tested 31 healthy young women matched for body mass index (mostly normal weight to overweight) and IQ. Depletion of peripheral precursors of dopamine reduced the working memory specific performance on the operation span task in the LFS, but not in the HFS group (P = 0.016). Learning from positive- and negative-reinforcement (probabilistic selection task) was increased in both diet groups after dopamine depletion (P = 0.049). As a secondary exploratory research question, we measured peripheral dopamine precursor availability (pDAP) at baseline as an estimate for central dopamine levels. The HFS group had a significantly higher pDAP at baseline compared to the LFS group (P = 0.025). Our data provide the first evidence indicating that the intake of HFS is associated with changes in dopamine precursor availability, which is suggestive of changes in central dopamine levels in humans. The observed associations are present in a sample of normal to overweight participants (ie, in the absence of obesity), suggesting that the consumption of a HFS might already be associated with altered behaviours. Alternatively, the effects of HFS diet and obesity might be independent.",2020,"Depletion of peripheral precursors of dopamine reduced the working memory specific performance on the operation span task in the LFS, but not in the HFS group (P = 0.016).","['31 healthy young women matched for body mass index (mostly normal weight to overweight) and IQ', 'two groups differing in habitual intake of dietary fat and sugar']",['LFS'],"['Learning from positive- and negative-reinforcement (probabilistic selection task', 'peripheral dopamine precursor availability (pDAP', 'pDAP']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0012171', 'cui_str': 'Dietary fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0085390', 'cui_str': 'Li-Fraumeni syndrome'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027561', 'cui_str': 'Negative reinforcement'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",31.0,0.0332674,"Depletion of peripheral precursors of dopamine reduced the working memory specific performance on the operation span task in the LFS, but not in the HFS group (P = 0.016).","[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Hartmann', 'Affiliation': ""Collaborative Research Centre 1052 'Obesity Mechanisms', Leipzig University Medical Center, Leipzig, Germany.""}, {'ForeName': 'Larissa K', 'Initials': 'LK', 'LastName': 'Pauli', 'Affiliation': 'Department of Neurology, MaxPlanck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Lieneke K', 'Initials': 'LK', 'LastName': 'Janssen', 'Affiliation': 'Department of Neurology, MaxPlanck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Huhn', 'Affiliation': 'Department of Neurology, MaxPlanck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Ceglarek', 'Affiliation': 'Institute for Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Horstmann', 'Affiliation': ""Collaborative Research Centre 1052 'Obesity Mechanisms', Leipzig University Medical Center, Leipzig, Germany.""}]",Journal of neuroendocrinology,['10.1111/jne.12917']
2440,33270930,Process evaluation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A mixed methods study.,"AIMS
To describe the implementation process and fidelity of two versions of a guideline-based, multicomponent intervention to reduce physical restraints in nursing homes and to identify factors that might explain the heterogeneity of effects between different clusters.
DESIGN
Mixed methods evaluation of the implementation process (dose delivered, dose received, response, and adaption) alongside a pragmatic three-arm cluster randomized controlled trial.
METHODS
Quantitative and qualitative process data were collected during the study period (February 2015-February 2017). Quantitative data from questionnaires and short surveys were analysed by descriptive statistics. Qualitative data from focus groups and semi-structured interviews were analysed using content analysis. An in-depth analysis was conducted by contrasting responding and non-responding clusters regarding the intervention goal and primary outcome.
RESULTS
Both interventions were implemented as planned in all clusters: we found no deviations from the protocol regarding the dose delivered to and received by the clusters. Satisfaction of staff targeted by the interventions was high. The in-depth analysis did not reveal any pronounced variation in the degree of implementation or adoption in clusters with a good or nearly no response to the interventions or factors explaining different study effects.
CONCLUSION
Although both versions of a guideline-based multicomponent intervention to prevent physical restraints in nursing homes were implemented as planned and the response was generally acceptable, the interventions' goal to change nursing practice towards a least-restraint policy was not achieved by the entire nursing staff in all of the clusters. No factors could be identified that might explain the different effects of the interventions.
IMPACT
For some nursing homes, different approaches than addressing nurses' attitudes and institutional policies might be needed to sustainably reduce the use of physical restraints; however, the process evaluation did not reveal characteristics that might have hampered or facilitated the effectiveness of the intervention.",2020,Both interventions were implemented as planned in all clusters: we found no deviations from the protocol regarding the dose delivered to and received by the clusters.,['nursing homes (IMPRINT'],"['guideline-based multicomponent intervention', 'multicomponent intervention', 'guideline-based, multicomponent intervention']",[],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0021118', 'cui_str': 'Imprinting (Psychology)'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0605027,Both interventions were implemented as planned in all clusters: we found no deviations from the protocol regarding the dose delivered to and received by the clusters.,"[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Bake', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Birte', 'Initials': 'B', 'LastName': 'Berger-Höger', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Köpke', 'Affiliation': 'Nursing Research Unit, Institute of Social Medicine & Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Kupfer', 'Affiliation': 'Nursing Research Unit, Institute of Social Medicine & Epidemiology, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Meyer', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Möhler', 'Affiliation': 'Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Halle (Saale), Germany.'}]",Journal of advanced nursing,['10.1111/jan.14694']
2441,33270911,"Efficacy and safety of chronomodulated Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin combination as first- or second-line treatment against metastatic colorectal cancer: results from the international EORTC 05011 trial.","The triplet combination of irinotecan, oxaliplatin and fluorouracil is an active frontline regimen in metastatic colorectal cancer, but scarce data exist on its use as salvage treatment. We aimed at assessing its safety and efficacy profiles with its circadian-based administration (chronoILFO5) as either first- or second-line treatment, within the time-finding EORTC 05011 trial. Five-day chronoIFLO5 was administered every 3 weeks in patients with PS 0, 1 or 2. It consisted of chronomodulated irinotecan (180 mg/sqm), oxaliplatin (80 mg/sqm) and fluorouracil-leucovorin (2800 and 1200 mg/sqm, respectively). For this study, toxicity and anti-tumour activity were evaluated separately in first- and second-line settings. Primary endpoints included grade 3-4 toxicity rates, best objective response rate (ORR), progression-free (PFS) and overall survival (OS). Respectively, 149 and 44 patients were treated in first- and second-line settings, with a total of 1138 cycles with median relative dose intensities of about 90%. Demographics were comparable in the two groups. 36 (24.7%) and 10 (22.2%) patients experienced at least one episode of severe toxicity in first- and second-line, respectively. Frontline chronoIFLO5 yielded an ORR of 62.3% [95% CI: 54.2-70.4] and resulted in median PFS and OS of 8.7 months [7.5-9.9] and 19.9 months [15.4-24.5]. Corresponding figures in second-line were 37.5% [22.5-52.5], 6.7 months [4.8-8.9] and 16.3 months [11.8-20.8]. International and prospective evaluation revealed the favourable safety and efficacy profiles of chronoIFLO5, both as frontline and as salvage treatment against metastatic colorectal cancer. In particular, encouraging activity in second-line was observed, with limited haematological toxicity.",2020,Frontline chronoIFLO5 yielded an ORR of 62.3% [95% CI: 54.2-70.4] and resulted in median PFS and OS of 8.7 months [7.5-9.9] and 19.9 months [15.4-24.5].,['metastatic colorectal cancer'],"['circadian-based administration (chronoILFO5', 'oxaliplatin', 'fluorouracil-leucovorin', 'chronomodulated Irinotecan, Oxaliplatin, 5-Fluorouracil and Leucovorin combination', 'irinotecan, oxaliplatin and fluorouracil', 'chronomodulated irinotecan', 'chronoIFLO5']","['severe toxicity', 'grade 3-4 toxicity rates, best objective response rate (ORR), progression-free (PFS) and overall survival (OS', 'Efficacy and safety', 'toxicity and anti-tumour activity', 'median PFS and OS', 'haematological toxicity']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0463207,Frontline chronoIFLO5 yielded an ORR of 62.3% [95% CI: 54.2-70.4] and resulted in median PFS and OS of 8.7 months [7.5-9.9] and 19.9 months [15.4-24.5].,"[{'ForeName': 'Pasquale F', 'Initials': 'PF', 'LastName': 'Innominato', 'Affiliation': 'North Wales Cancer Centre, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board, Bangor, United Kingdom.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Karaboué', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Focan', 'Affiliation': 'Department of Oncology, CHC- MontLegia, Groupe Santé, CHC-Liège, Liège, Belgium.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Chollet', 'Affiliation': 'Clinical and Translational Research Division, Jean Perrin Comprehensive Cancer Centre, Clermont-Ferrand, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Giacchetti', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouchahda', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Ayhan', 'Initials': 'A', 'LastName': 'Ulusakarya', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Torsello', 'Affiliation': 'Division of Medical Oncology, San Giovanni- Addolorata Hospital, Rome, Italy.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Adam', 'Affiliation': 'UPR ""Chronotherapy, Cancers and Transplantation"", Faculty of Medicine, Paris-Saclay University, Villejuif, France.'}, {'ForeName': 'Francis A', 'Initials': 'FA', 'LastName': 'Lévi', 'Affiliation': 'Cancer Chronotherapy Team, Cancer Research Centre, Division of Biomedical Sciences, Warwick Medical School, Coventry, United Kingdom.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Garufi', 'Affiliation': 'Division of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy.'}]",International journal of cancer,['10.1002/ijc.33422']
2442,33270835,Internal hexagon versus conical implant-abutment connections: evaluation of 3-year postloading outcomes.,"Different types of internal implant-abutment connections, namely hexagon and conical, have been used for implant restoration. However, data regarding the benefits of these internal connections in terms of clinical outcomes are scarce. Accordingly, the aim of this study was to compare radiographic marginal bone loss (RMBL) and associated implant complications between implants with internal hexagon (IH) connections and those with internal conical (IC) connections. Forty-nine patients with 98 implants (two per patient) placed in the posterior mandible were recruited. All implants were inserted in pairs in solid D2 bone according to a randomized sequence; the first patient received an IH connection implant on the mesial side while the second patient received an IC connection implant on the mesial side. Each patient received one implant with an IH connection and one with an IC connection, placed side-by-side. Four months after placement, all implants were loaded with single screw-retained ceramic restorations with internal hexagon or conical connections. RMBL and complications, including implant/prosthesis failure, were recorded at the time of implant loading (baseline) and 6, 12, and 36 months after loading. The results revealed no significant between-group differences in RMBL (P = .74), gingival bleeding on probing (P = .29), and complications (P = .32). Thus, the type of internal implant-abutment connection did not affect clinical outcomes, including RMBL and implant/prosthesis failure. Future studies should additionally evaluate long-term prosthesis-related complications such as screw loosening and fracture between the two types of internal connections.",2020,"The results revealed no significant between-group differences in RMBL (P = .74), gingival bleeding on probing (P = .29), and complications (P = .32).","['implants with internal hexagon (IH) connections and those with internal conical (IC) connections', 'Forty-nine patients with\xa098 implants (two per patient) placed in the posterior mandible were recruited']","['one implant with an IH connection and one with an IC connection, placed side-by-side', 'IH connection implant on the mesial side while the second patient received an IC connection implant', 'Internal hexagon versus conical implant-abutment connections']","['gingival bleeding on probing', 'RMBL', 'RMBL and complications, including implant/prosthesis failure', 'RMBL and implant/prosthesis failure', 'radiographic marginal bone loss (RMBL']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0376349', 'cui_str': 'Bleeding on probing of gingivae'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0033586', 'cui_str': 'Prosthesis Failure'}]",49.0,0.0513243,"The results revealed no significant between-group differences in RMBL (P = .74), gingival bleeding on probing (P = .29), and complications (P = .32).","[{'ForeName': 'Sorin', 'Initials': 'S', 'LastName': 'Mihali', 'Affiliation': 'Universitate de Vest Vasile Goldis din Arad Associate Professor Prosthotontics, Implantology B-dul Revoluției nr. 94 ROMANIA Arad Arad 300433 Universitate de Vest Vasile Goldis din Arad.'}, {'ForeName': 'Hom-Lay', 'Initials': 'HL', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Olimpiu', 'Initials': 'O', 'LastName': 'Karancsi', 'Affiliation': ''}, {'ForeName': 'Emanuel Adrian', 'Initials': 'EA', 'LastName': 'Bratu', 'Affiliation': ''}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00160']
2443,33031652,Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19.,"BACKGROUND
Hydroxychloroquine and chloroquine have been proposed as treatments for coronavirus disease 2019 (Covid-19) on the basis of in vitro activity and data from uncontrolled studies and small, randomized trials.
METHODS
In this randomized, controlled, open-label platform trial comparing a range of possible treatments with usual care in patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive hydroxychloroquine and 3155 to receive usual care. The primary outcome was 28-day mortality.
RESULTS
The enrollment of patients in the hydroxychloroquine group was closed on June 5, 2020, after an interim analysis determined that there was a lack of efficacy. Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15). Consistent results were seen in all prespecified subgroups of patients. The results suggest that patients in the hydroxychloroquine group were less likely to be discharged from the hospital alive within 28 days than those in the usual-care group (59.6% vs. 62.9%; rate ratio, 0.90; 95% CI, 0.83 to 0.98). Among the patients who were not undergoing mechanical ventilation at baseline, those in the hydroxychloroquine group had a higher frequency of invasive mechanical ventilation or death (30.7% vs. 26.9%; risk ratio, 1.14; 95% CI, 1.03 to 1.27). There was a small numerical excess of cardiac deaths (0.4 percentage points) but no difference in the incidence of new major cardiac arrhythmia among the patients who received hydroxychloroquine.
CONCLUSIONS
Among patients hospitalized with Covid-19, those who received hydroxychloroquine did not have a lower incidence of death at 28 days than those who received usual care. (Funded by UK Research and Innovation and National Institute for Health Research and others; RECOVERY ISRCTN number, ISRCTN50189673; ClinicalTrials.gov number, NCT04381936.).",2020,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","['patients hospitalized with Covid-19, we randomly assigned 1561 patients to receive', 'coronavirus disease 2019 ', 'Hospitalized Patients with Covid-19', 'patients hospitalized with Covid-19']","['hydroxychloroquine', 'hydroxychloroquine and 3155 to receive usual care', 'Hydroxychloroquine and chloroquine', 'Hydroxychloroquine', 'usual care']","['cardiac deaths', 'death', '28-day mortality', 'frequency of invasive mechanical ventilation or death', 'Death', 'incidence of new major cardiac arrhythmia', 'hospital alive']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}]","[{'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",1561.0,0.344094,"Death within 28 days occurred in 421 patients (27.0%) in the hydroxychloroquine group and in 790 (25.0%) in the usual-care group (rate ratio, 1.09; 95% confidence interval [CI], 0.97 to 1.23; P = 0.15).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Staplin', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Emberson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wiselka', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ustianowski', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Einas', 'Initials': 'E', 'LastName': 'Elmahi', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Prudon', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Whitehouse', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jakki', 'Initials': 'J', 'LastName': 'Faccenda', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Underwood', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Jeffery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Montgomery', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Tarning', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Watson', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'White', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Landray', 'Affiliation': ""The affiliations of the members of the writing committee are as follows: the Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine (P.H., J.T., J.A.W., N.J.W.), Nuffield Department of Population Health (M.M., L.L., J.L.B., N.S., J.R.E., E.J., R.H., M.J.L.), the Medical Research Council (MRC) Population Health Research Unit (N.S., J.R.E., R.H., M.J.L.), University of Oxford, the Oxford University Hospitals NHS Foundation Trust (K.J., M.J.L.), and the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (M.J.L.), Oxford, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester (M.W.), the Regional Infectious Diseases Unit, North Manchester General Hospital (A.U.), University of Manchester (A.U., T.F.), and Manchester University NHS Foundation Trust (T.F.), Manchester, the Research and Development Department, Northampton General Hospital, Northampton (E.E.), the Department of Respiratory Medicine, North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees (B.P.), University Hospitals Birmingham NHS Foundation Trust and Institute of Microbiology and Infection, University of Birmingham, Birmingham (T.W.), James Cook University Hospital, Middlesbrough (J.W.), North West Anglia NHS Foundation Trust, Peterborough (J.F.), the Department of Infectious Diseases, Cardiff and Vale University Health Board, and the Division of Infection and Immunity, Cardiff University, Cardiff (J.U.), Roslin Institute, University of Edinburgh, Edinburgh (J.K.B.), the School of Life Course Sciences, King's College London (L.C.C.), and the Intensive Care National Audit and Research Centre (K.R.), London, the NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton (S.N.F.), the Department of Mathematics and Statistics, Lancaster University, Lancaster (T.J.), the MRC Biostatistics Unit, University of Cambridge, Cambridge (T.J.), and the Respiratory Medicine Department, Nottingham University Hospitals NHS Trust (W.S.L.), and the School of Medicine, University of Nottingham (A.M., E.J.), Nottingham - all in the United Kingdom; and the Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand (J.T., J.A.W., N.J.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa2022926']
2444,33063862,"Efficacy of Galcanezumab for Migraine Prevention in Patients With a Medical History of Anxiety and/or Depression: A Post Hoc Analysis of the Phase 3, Randomized, Double-Blind, Placebo-Controlled REGAIN, and Pooled EVOLVE-1 and EVOLVE-2 Studies.","OBJECTIVE
This post hoc analysis evaluated the efficacy of galcanezumab for the prevention of migraine in patients with and without comorbid anxiety and/or depression.
BACKGROUND
Patients with migraine have a higher risk of anxiety and/or depression. Given the high prevalence of psychiatric symptoms and their potential negative prognostic impact, determining the efficacy of migraine treatments in patients with these comorbidities is important.
METHODS
The results of 2 phase 3 episodic migraine studies of patients with 4-14 migraine headache days (MHD) per month were pooled. A third chronic migraine study, which was evaluated separately, enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features. Patients in all 3 studies were randomized 2:1:1 to placebo, galcanezumab 120 mg, or galcanezumab 240 mg. The efficacy of galcanezumab on migraine was measured in subgroups of patients with anxiety and/or depression (current or past) and patients without. A repeated measures model was used to compare treatment groups within each subgroup and to test for consistency of treatment effect across the anxiety/depression subgroups (subgroup-by-treatment interaction) during the double-blind treatment phases.
RESULTS
Among 1773 intent-to-treat patients with episodic migraine, both doses of galcanezumab demonstrated statistically significant improvements relative to placebo in overall number of MHD for the subgroups of patients with anxiety and/or depression (mean change difference from placebo [95% CI]: -2.07 [-2.81, -1.33] for galcanezumab 120 mg [P < .001], -1.91 [-2.78, -1.04] for 240 mg [P < .001]) and without anxiety and/or depression (mean change difference from placebo [95% CI]: -1.92 [-2.36, -1.47] for 120 mg [P < .001], -1.77 [-2.20, -1.33] for 240 mg [P < .001]), as was observed for the secondary outcomes of MHD with acute medication use and functional impairment. Among 1113 intent-to-treat patients with chronic migraine, those with anxiety and/or depression had significant reductions in overall MHD frequency with the 240-mg dose (mean change difference from placebo [95% CI]: -1.92 [-3.52, -0.33]; P = .018), whereas significant reductions were observed at both the 120-mg (mean change difference from placebo [95% CI]: -2.29 [-3.26, -1.31]; P < .001) and 240-mg (-1.85 [-2.83, -0.87]; P < .001) doses in patients without anxiety and/or depressions. Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression. In the episodic and chronic migraine studies, the subgroup-by-treatment interaction was not statistically significant for MHD, MHD with acute medication use, or functional impairment (chronic study only), suggesting a lack of evidence of differential effect between subgroups. Furthermore, differences between subgroups in the mean change differences from placebo, as well as overlapping 95% confidence intervals for the subgroups, indicated lack of a clinical or statistical difference between subgroups for these outcome variables. There was a significantly higher percentage of patients with episodic migraine attaining ≥50%, ≥75%, and 100% reductions, and a higher percentage of patients with chronic migraine attaining ≥50% and ≥75% reductions from baseline with galcanezumab compared with placebo, regardless of medical history of anxiety and/or depression.
CONCLUSIONS
A medical history of anxiety and/or depression does not seem to interfere with response to galcanezumab among patients with episodic migraine, and both doses of galcanezumab appear efficacious for these individuals regardless of this psychiatric history. Among patients with chronic migraine and comorbid anxiety and/or depression, the 240-mg dose, but not the 120-mg dose, significantly decreased overall MHD, but neither dose resulted in significantly greater functional improvement. Patients with migraine and comorbid anxiety and/or depression often require additional interventions, and this may be more important in chronic migraine.",2020,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","['enrolled patients with ≥15 headache days per month, of which ≥8 had migraine-like features', 'Patients With a Medical History of Anxiety', 'subgroups of patients with anxiety and/or depression (current or past) and patients without', 'patients with these comorbidities is important', 'Patients with migraine and comorbid anxiety and/or depression often require additional interventions', 'and/or Depression', 'patients with episodic migraine', 'patients with 4-14 migraine headache days (MHD) per month were pooled', 'patients with and without comorbid anxiety and/or depression']","['Galcanezumab', 'galcanezumab', 'placebo', 'placebo, galcanezumab 120\xa0mg, or galcanezumab 240\xa0mg', 'Placebo']","['chronic migraine', 'MHD with acute medication use and functional impairment', 'comorbid anxiety and/or depression', 'migraine', 'anxiety and/or depression', 'overall MHD', 'overall functional impairment', 'functional improvement', 'overall number of MHD', 'episodic migraine', 'overall MHD frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1444635', 'cui_str': 'Current or past'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0337051', 'cui_str': 'Pool'}]","[{'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319600', 'cui_str': '240'}]","[{'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.162567,"Significant reductions (P < .01) in MHD with acute medication use were observed at both doses within both anxiety/depression subgroups and for overall functional impairment for patients without anxiety and/or depression, though neither dose significantly reduced overall functional impairment beyond placebo in the subgroup with anxiety and/or depression.","[{'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Smitherman', 'Affiliation': 'Department of Psychology, The University of Mississippi, University, MS, USA.'}, {'ForeName': 'Gretchen E', 'Initials': 'GE', 'LastName': 'Tietjen', 'Affiliation': 'Department of Neurology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Kory', 'Initials': 'K', 'LastName': 'Schuh', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Skljarevski', 'Affiliation': 'Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lipsius', 'Affiliation': 'Department of Statistics, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Deborah N', 'Initials': 'DN', 'LastName': ""D'Souza"", 'Affiliation': 'Clinical Solutions, Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Pearlman', 'Affiliation': 'Medical Affairs, Eli Lilly and Company, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.13970']
2445,33064780,"Alcohol use, depressive symptoms, and intimate partner violence perpetration: A longitudinal analysis among men with HIV in northern Vietnam.","BACKGROUND
While the link between alcohol use and male-perpetrated intimate partner violence (IPV) has been well-established, research is needed to test whether psychosocial factors interact with alcohol use to exacerbate IPV perpetration. We tested whether depressive symptoms influenced the strength and/or direction of the alcohol-IPV relationship among men with HIV in Vietnam.
METHODS
This study is a secondary analysis using data from a randomized controlled trial conducted in Thai Nguyen, Vietnam. Participants were clinic patients with HIV and hazardous alcohol use. Questionnaires were administered at baseline, three, six, and 12 months. Alcohol use was assessed as proportion of days alcohol abstinent. Analyses were restricted to males who reported being married/cohabitating at baseline (N = 313). Multilevel growth models were used to test whether time-varying depressive symptoms modified the time-varying effect of alcohol use on IPV perpetration.
RESULTS
Time-varying depressive symptoms modified the effect of proportion of days alcohol abstinent on IPV perpetration. However, the pattern of effect modification was not as expected, as reporting depressive symptoms weakened the alcohol-IPV relationship. At times when participants screened negative for depressive symptoms, those who reported higher proportion of days alcohol abstinent than usual had significantly lower odds of IPV perpetration (Odds Ratio [OR] = 0.17, 95% Confidence Interval 0.06, 0.45, p = 0.0004). At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
CONCLUSION
The findings highlight the complex nature of the alcohol-IPV relationship and the need to investigate the intersection between hazardous drinking, mental health, and IPV. Men who concurrently report depressive symptoms and heightened alcohol use may be socially isolated from an intimate partner or experiencing fatigue, leading to less alcohol-related IPV perpetration. Mental health interventions addressing depression and alcohol misuse integrated into HIV services may reduce IPV perpetration.",2020,"At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
","['males who reported being married/cohabitating at baseline', 'Men who concurrently report depressive symptoms and heightened alcohol use may be socially isolated from an intimate partner or experiencing fatigue, leading to less alcohol-related IPV perpetration', 'Participants were clinic patients with HIV and hazardous alcohol use', 'men with HIV in Vietnam', 'men with HIV in northern Vietnam', 'male-perpetrated intimate partner violence (IPV', 'Thai Nguyen, Vietnam']",[],"['Alcohol use, depressive symptoms, and intimate partner violence perpetration', 'depressive symptoms', 'IPV perpetration', 'alcohol use on IPV perpetration', 'proportion of days alcohol abstinent']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0442803', 'cui_str': 'Heightened'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}]",[],"[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}]",313.0,0.0537053,"At times when participants screened positive for depressive symptoms, there was no observed effect of alcohol use on IPV perpetration (OR = 4.28, 95% CI 0.80, 22.78, p = 0.09).
","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'H Luz McNaughton', 'Initials': 'HLM', 'LastName': 'Reyes', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Nguyen Vu Tuyet', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'Yen Hoa Health Clinic, University of North Carolina Vietnam, Hanoi, Vietnam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0240674']
2446,33263669,"Effect of different surface treatments and multimode adhesive application on the Weibull characteristics, wettability, surface topography and adhesion to CAD/CAM lithium disilicate ceramic.","METHODOLOGY
This paper aims to evaluate the effect of different surface treatments on surface topography, wettability, and shear bond strength of resin cement to glass ceramic. For SBS test, 32 blocks (7x7x2 mm) of lithium disilicate were obtained and randomly divided into eight groups (four blocks per group) according to each surface treatment (HF 20 s, 60 s, 120 s + silanization/S or Scotch Bond Universal/ SBU) and the Monobond Etch & Prime - MEP application followed or not by SBU. On each treated surface ceramic block, up to four dual-curing resin cement cylinders were prepared and light-cured for 40s (N=120/n=15). The specimens were thermocycled (10,000 cycles, 5-55°C, 30 s) and the SBS test (50KgF, 0.5 mm/min) was performed. Furthermore, failure analysis, wettability, AFM, and SEM were carried out. SBS data (MPa) were analyzed using Student's t-test, two-way ANOVA, Tukey's test (5%) and Weibull's analysis.
RESULTS
For HF experimental groups, two-way ANOVA presented the factors ""etching time"" and ""bonding agent"" as significant (p<0.05). After silane application, the HF groups presented similar bond strength. SBU application compromised the SBS, except for 120s etching time (HF120sS: 23.39ᵃ±6.48 MPa; HF120sSBU: 18.76ᵃ±8.81MPa). For MEP groups, SBU application did not significantly affect the results (p=0.41). The MEP group presented the highest Weibull modulus (4.08A) and they were statistically different exclusively from the HF20sSBU (0.58B).
CONCLUSION
The HF 20s, 60s, 120 s followed by silane, promoted similar resin-bond strength to ceramic and the SBU application after HF or MEP did not increase the SBS.",2020,"The HF 20s, 60s, 120 s followed by silane, promoted similar resin-bond strength to ceramic and the SBU application after HF or MEP did not increase the SBS.",[],"['resin cement to glass ceramic', 'Monobond Etch & Prime - MEP application followed or not by SBU', 'lithium disilicate']","['SBU application', 'bond strength', 'Weibull characteristics, wettability, surface topography and adhesion to CAD/CAM lithium disilicate ceramic', 'SBS data (MPa', 'Furthermore, failure analysis, wettability, AFM, and SEM', 'surface topography, wettability, and shear bond strength', 'SBS']",[],"[{'cui': 'C0376523', 'cui_str': 'Resin Cement'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0908735', 'cui_str': 'Etch&Prime'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0162598', 'cui_str': 'Wetability'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C0025147', 'cui_str': 'Medroxyprogesterone'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242849', 'cui_str': 'Atomic Force Microscopy'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}]",,0.0189084,"The HF 20s, 60s, 120 s followed by silane, promoted similar resin-bond strength to ceramic and the SBU application after HF or MEP did not increase the SBS.","[{'ForeName': 'Karina Barbosa', 'Initials': 'KB', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio Grande do Norte (UFRN), Departamento de Odontologia, Natal / RN, Brasil.'}, {'ForeName': 'Dayanne Monielle Duarte', 'Initials': 'DMD', 'LastName': 'Moura', 'Affiliation': 'Universidade Federal do Rio Grande do Norte (UFRN), Departamento de Odontologia, Natal / RN, Brasil.'}, {'ForeName': 'Sarah Emille Gomes da', 'Initials': 'SEGD', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Rio Grande do Norte (UFRN), Departamento de Odontologia, Natal / RN, Brasil.'}, {'ForeName': 'Gabriela Monteiro de', 'Initials': 'GM', 'LastName': 'Araújo', 'Affiliation': 'Universidade Federal do Rio Grande do Norte (UFRN), Departamento de Odontologia, Natal / RN, Brasil.'}, {'ForeName': 'Rafael de Almeida Spinelli', 'Initials': 'RAS', 'LastName': 'Pinto', 'Affiliation': 'Universidade Federal de Juiz de Fora (UFJF), Departamento de Odontologia, Juiz de Fora, MG, Brasil.'}, {'ForeName': 'Fabíola Pessôa Pereira', 'Initials': 'FPP', 'LastName': 'Leite', 'Affiliation': 'Universidade Federal de Juiz de Fora (UFJF), Departamento de Odontologia, Juiz de Fora, MG, Brasil.'}, {'ForeName': 'Mutlu', 'Initials': 'M', 'LastName': 'Özcan', 'Affiliation': 'University of Zurich, Division of Dental Biomaterials, Clinic for Reconstructive Dentistry, Center of Dental Medicine, Zurich, Switzerland.'}, {'ForeName': 'Rodrigo Othávio de Assunção E', 'Initials': 'ROAE', 'LastName': 'Souza', 'Affiliation': 'Universidade Federal do Rio Grande do Norte (UFRN), Departamento de Odontologia, Natal / RN, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0122']
2447,33263644,Efficacy of oseltamivir compared with zanamivir in COPD patients with seasonal influenza virus infection: a randomized controlled trial.,"Influenza viruses exacerbate chronic obstructive pulmonary disease (COPD) with considerable morbidity and mortality. Zanamivir and oseltamivir are effective in treating influenza. However, their efficacy in relieving influenza symptoms in COPD patients remains unknown, with the lack of controlled trials in this subject. Therefore, we conducted this randomized controlled trial to investigate the clinical efficacy of both interventions in this population. Patients were allocated to two groups (80 patients each): oseltamivir (OSELTA) and zanamivir (ZANA) groups. Oseltamivir (75 mg) was orally administered twice daily for 5 days, while zanamivir (10 mg) was inhaled twice daily for 5 days. Clinical parameters including body temperature, influenza symptoms (i.e., sore throat, cough, etc.), and serial blood tests were recorded on days 1, 3, and 7. We analyzed primary (changes in body temperature) and secondary outcomes (changes in non-specific symptoms) using the pre-protocol and intention-to-treat analyses. Differences between groups were assessed using t-test. Oseltamivir and zanamivir significantly reduced body temperature on the 3rd day after treatment; however, the number of patients who reported clinical improvement in influenza-like symptoms was significantly higher in the OSELTA group compared to the ZANA group on days 3 (85 vs 68.8%, P=0.015) and 7 (97.5 vs 83.8%, P=0.003). However, no significant changes in hematological (white blood cells and its subtypes) and inflammatory (C-reactive protein) parameters were noted (P>0.05). Our results suggested that oseltamivir and zanamivir are effective in reducing body temperature, while oseltamivir led to better clinical improvement regarding influenza-like symptoms in patients with COPD.",2020,"However, no significant changes in hematological (white blood cells and its subtypes) and inflammatory (C-reactive protein) parameters were noted (P>0.05).","['Influenza viruses exacerbate chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'COPD patients', 'COPD patients with seasonal influenza virus infection']","['oseltamivir (OSELTA) and zanamivir (ZANA', 'zanamivir', 'oseltamivir', 'ZANA', 'oseltamivir and zanamivir', 'Zanamivir and oseltamivir', 'Oseltamivir and zanamivir', 'Oseltamivir']","['body temperature', 'body temperature, influenza symptoms (i.e., sore throat, cough, etc.), and serial blood tests', 'hematological (white blood cells and its subtypes) and inflammatory (C-reactive protein) parameters', 'influenza-like symptoms']","[{'cui': 'C0029341', 'cui_str': 'Family Orthomyxoviridae'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0216660', 'cui_str': 'Zanamivir'}]","[{'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}]",,0.0785725,"However, no significant changes in hematological (white blood cells and its subtypes) and inflammatory (C-reactive protein) parameters were noted (P>0.05).","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Section 1, Department of Respiratory and Critical Care Medicine, Cangzhou Central Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Guang-Chao', 'Initials': 'GC', 'LastName': 'Han', 'Affiliation': 'Section 1, Department of Respiratory and Critical Care Medicine, Cangzhou Central Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Section 1, Department of Respiratory and Critical Care Medicine, Cangzhou Central Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Wen-Xiu', 'Initials': 'WX', 'LastName': 'Du', 'Affiliation': 'Section 1, Department of Respiratory and Critical Care Medicine, Cangzhou Central Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Section 1, Department of Respiratory and Critical Care Medicine, Cangzhou Central Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Yu-Min', 'Initials': 'YM', 'LastName': 'Chi', 'Affiliation': 'Section 1, Department of Respiratory and Critical Care Medicine, Cangzhou Central Hospital, Cangzhou, Hebei, China.'}, {'ForeName': 'Jun-Feng', 'Initials': 'JF', 'LastName': 'Du', 'Affiliation': 'Section 1, Department of Respiratory and Critical Care Medicine, Cangzhou Central Hospital, Cangzhou, Hebei, China.'}]",Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologicas,['10.1590/1414-431X20209542']
2448,33263629,Effects of an Intratympanic Injection of Dexamethasone Combined with Gentamicin on the Expression Level of Serum P0 Protein Antibodies in Patients with Meniere's Disease.,"OBJECTIVES
To investigate the effects of an intratympanic injection of dexamethasone combined with gentamicin on the expression level of serum P0 protein antibodies in patients with Meniere's disease (MD).
METHODS
A total of 136 patients with MD treated in our hospital were enrolled in this study. Among them, 68 patients were treated with an intratympanic injection of dexamethasone combined with gentamicin (observation group). Another 68 patients were treated with gentamicin alone (control group).
RESULTS
After treatment, the expression levels of IgG and IgM in the two groups significantly decreased (p<0.05); the levels in the observation group were significantly lower than those in the control group (p<0.05). The incidences of vertigo, tinnitus, and gait instability in the observation group were significantly lower than those in the control group (p<0.05). Vestibular symptom index (VSI) scores in the observation group were significantly lower than those in the control group (p<0.05). We observed no significant difference between the two groups in the number of vertigo attacks 6 months after treatment (p>0.05).
CONCLUSION
For patients with MD, dexamethasone combined with gentamicin can reduce the incidence of vertigo, tinnitus, and gait instability, but it has no effect on the efficacy or number of vertigo attacks 6 months after treatment. Therefore, the levels of myelin P0 protein antibodies after treatment can be used as predictors of vertigo at 6 months after treatment.",2020,"After treatment, the expression levels of IgG and IgM in the two groups significantly decreased (p<0.05); the levels in the observation group were significantly lower than those in the control group (p<0.05).","['136 patients with MD treated in our hospital were enrolled in this study', ""patients with Meniere's disease (MD"", ""Patients with Meniere's Disease"", '68 patients were treated with an intratympanic injection of']","['gentamicin alone (control group', 'Dexamethasone Combined with Gentamicin', 'dexamethasone', 'dexamethasone combined with gentamicin', 'gentamicin']","['incidences of vertigo, tinnitus, and gait instability', 'levels of myelin P0 protein antibodies', 'number of vertigo attacks', 'incidence of vertigo, tinnitus, and gait instability', 'expression level of serum P0 protein antibodies', 'Vestibular symptom index (VSI) scores', 'expression levels of IgG and IgM', 'Expression Level of Serum P0 Protein Antibodies']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025281', 'cui_str': ""Ménière's disease""}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1555371', 'cui_str': 'Intratympanic Injection'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231686', 'cui_str': 'Unsteady gait'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0071316', 'cui_str': 'Protein Zero, Peripheral Nerve Myelin'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}]",136.0,0.0186521,"After treatment, the expression levels of IgG and IgM in the two groups significantly decreased (p<0.05); the levels in the observation group were significantly lower than those in the control group (p<0.05).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong, China.'}, {'ForeName': 'Wenping', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong, China.'}, {'ForeName': 'Fengfang', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Otolaryngology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Feng', 'Affiliation': 'Department of Otolaryngology, Zibo Central Hospital, Zibo, Shandong, China.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e1622']
2449,33263621,"Comments on ""Transcutaneous tibial nerve stimulation versus parasacral stimulation in the treatment of overactive bladder in elderly people: A triple-blinded randomized controlled trial"".",,2020,,['overactive bladder in elderly people'],['Transcutaneous tibial nerve stimulation versus parasacral stimulation'],[],"[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040186', 'cui_str': 'Structure of tibial nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.175273,,"[{'ForeName': 'Apoorva', 'Initials': 'A', 'LastName': 'Srivastav', 'Affiliation': 'Department of Neurological Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Neurological Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India.'}, {'ForeName': 'Adarsh Kumar', 'Initials': 'AK', 'LastName': 'Srivastav', 'Affiliation': 'University Research Fellow, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India.'}]","Clinics (Sao Paulo, Brazil)",['10.6061/clinics/2020/e2214']
2450,33263447,Reduced wear in vitamin E-infused highly cross-linked polyethylene cups: 5-year results of a randomized controlled trial.,"Background and purpose - Vitamin E-infused polyethylene is a relatively new material in joint arthroplasty; there are no long-term reports, and only few mid-term results. Using radiostereometric analysis (RSA), we primarily determined whether vitamin E-infused highly cross-linked polyethylene (HXLPE/VitE) acetabular cups show less wear than ultra-high molecular weight polyethylene (UHMWPE) acetabular cups at 5 years after total hip arthroplasty (THA). We also assessed whether wear rates correlate with increasing cup inclination angles or cup sizes. Patients and methods - This is a 5-year follow-up of our previously reported randomized controlled trial of 62 patients with 3 years' follow-up, who received THA with either an HXLPE/VitE or a UHMWPE acetabular cup. At 5 years, 40 patients were analyzed (22 in the HXLPE/VitE and 18 in the UHMWPE group). Results - HXLPE/VitE cups continued to show less cumulative femoral head penetration than UHMWPE cups (HXLPE/VitE: 0.24 mm, UHMWPE: 0.45 mm; p < 0.001). Distribution of wear was also more even with HXLPE/VitE cups than with UHMWPE cups (p = 0.002). Moreover, the difference in PE wear between 1 and 5 years in both groups showed no statistically significant correlation with increasing cup inclination angles or cup sizes. Finally, no osteolysis and implant loosening occurred, and no revision surgeries were required. Interpretation - Wear rates continue to be lower in HXLPE/VitE cups than in UHMWPE cups at 5 years of follow-up without correlation with increasing cup inclination angles or cup sizes. Finally, HXLPE/VitE cups may have the potential to prevent osteolysis and implant loosening.",2020,"Results - HXLPE/VitE cups continued to show less cumulative femoral head penetration than UHMWPE cups (HXLPE/VitE: 0.24 mm, UHMWPE: 0.45 mm; p < 0.001).","[""62 patients with 3 years' follow-up, who received THA with either an""]","['ultra-high molecular weight polyethylene (UHMWPE) acetabular cups', 'vitamin E-infused highly cross-linked polyethylene (HXLPE/VitE', 'Vitamin E-infused polyethylene', 'HXLPE/VitE or a UHMWPE acetabular cup', 'vitamin E-infused highly cross-linked polyethylene cups']","['osteolysis and implant loosening', 'cumulative femoral head penetration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}]","[{'cui': 'C0673477', 'cui_str': 'ultra-high molecular weight polyethylene'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C1142098', 'cui_str': 'Vitamin E measurement'}]","[{'cui': 'C4721411', 'cui_str': 'Osteolysis'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}]",62.0,0.158006,"Results - HXLPE/VitE cups continued to show less cumulative femoral head penetration than UHMWPE cups (HXLPE/VitE: 0.24 mm, UHMWPE: 0.45 mm; p < 0.001).","[{'ForeName': 'Goulven', 'Initials': 'G', 'LastName': 'Rochcongar', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Remazeilles', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'Emeline', 'Initials': 'E', 'LastName': 'Bourroux', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Dunet', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Chapus', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Feron', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Praz', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Buia', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hulet', 'Affiliation': 'Caen Normandy University Hospital Centre, Department of Orthopaedic and Trauma Surgery , 14000 , Caen , France.'}]",Acta orthopaedica,['10.1080/17453674.2020.1852785']
2451,33262710,A Randomized-Controlled Trial of Mentalization-Based Treatment Compared With Structured Case Management for Borderline Personality Disorder in a Mainstream Public Health Service.,"Background: Treatment of borderline personality disorder (BPD) in publicly funded mental health services generally use approaches based on medical interventions and generic case management. Specific psychological therapies developed for BPD may be more effective but have rarely been evaluated in routine clinical practice. Aim: To examine the effectiveness of Mentalization Based Treatment (MBT) in adults with an established diagnosis of BPD under the care of a publicly funded Mental Health Service (MHS), on rates of non-suicidal self-harm (NSSH) and attempted suicide (SA). Methods: A randomized, controlled trial (RCT) comparing 18 months of MBT with Enhanced Therapeutic Case Management (ETCM), a form of Structured Clinical Case Management (ICTRP: ACTRN12612000951853). Participants were adults recruited from a patient population under the care of a publicly funded mental health service (MHS) with a confirmed diagnosis of BPD. The primary outcome measures were the incidence of non-suicidal self-harm or suicide attempt over 18 months of treatment. Results: 72 participants (71 females, 1 male) were randomized to MBT ( n = 38) or ETCM ( n = 34). Both groups showed a significant reduction in the overall incident rate of SA and NSSH. Between groups, SA rates were higher in the MBT group and conversely NSSH rates were higher in the ECTM group. Conclusions: The introduction of a structured service that delivered a structured psychotherapy (MBT) and an effective case management approach (ETCM) both resulted in a reduction in SA and NSSH. The differences in improvements found between groups within this study setting will require further research.",2020,"Between groups, SA rates were higher in the MBT group and conversely NSSH rates were higher in the ECTM group. ","['Participants were adults recruited from a patient population under the care of a publicly funded mental health service (MHS) with a confirmed diagnosis of BPD', 'adults with an established diagnosis of BPD under the care of a publicly funded Mental Health Service (MHS), on rates of non-suicidal self-harm (NSSH) and attempted suicide (SA', 'Borderline Personality Disorder in a Mainstream Public Health Service', '72 participants (71 females, 1 male', 'borderline personality disorder (BPD) in publicly funded mental health services']","['MBT', 'structured service that delivered a structured psychotherapy (MBT) and an effective case management approach (ETCM', 'MBT with Enhanced Therapeutic Case Management (ETCM), a form of Structured Clinical Case Management (ICTRP', 'Mentalization-Based Treatment Compared With Structured Case Management', 'Mentalization Based Treatment (MBT', 'ETCM', 'ECTM']","['incidence of non-suicidal self-harm or suicide attempt over 18 months of treatment', 'overall incident rate of SA and NSSH', 'NSSH rates', 'SA rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0041734', 'cui_str': 'United States. Public Health Service'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",72.0,0.167823,"Between groups, SA rates were higher in the MBT group and conversely NSSH rates were higher in the ECTM group. ","[{'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Carlyle', 'Affiliation': 'Department Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Canterbury District Health Board, Mental Health Services, Christchurch, New Zealand.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Inder', 'Affiliation': 'Department Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Porter', 'Affiliation': 'Department Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Crowe', 'Affiliation': 'Department Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Mulder', 'Affiliation': 'Department Psychological Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frampton', 'Affiliation': 'Department Psychological Medicine, University of Otago, Christchurch, New Zealand.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.561916']
2452,33262708,Effect of Short-Term Kinesiology Taping on Knee Proprioception and Quadriceps Performance in Healthy Individuals.,"Background : Kinesiology taping (KT) is well known measure for preventing musculoskeletal injuries. Our study aims to explore the actual effects of KT on healthy participants' knee proprioception and quadriceps performance within 1 h. Methods : A total of 35 healthy male amateur runners were recruited in our study. Four taping sequences were randomly allocated to four different weeks, namely, no taping, placebo taping, KT with tension, and KT with no tension. A CON-TREX isokinetic dynamometer was used in assessing the participants' knee proprioception and muscle strength of knee extension and flexion at 60°/s. The electromyography (EMG) signals of medial oblique muscle and vastus lateralis were collected using Myon EMG system synchronously. Two-way repeated measures ANOVA was used in exploring the difference between taping and time effects, and the significance was set to alpha <0.05. Results : Significant interaction effect was found between the taping groups and time effect [ F (3.32) = 2.389, p = 0.029, η 2 = 0.050] in the peak torque during the concentric contraction of quadriceps. No significant interaction and no significant differences between groups and time effects in knee proprioception and muscle activation. Conclusion : The effect of KT seems insufficiently large to impose a positive effect on healthy people within short periods. Health participants may not necessarily use KT to increase muscle activation and proprioception of knee.",2020,No significant interaction and no significant differences between groups and time effects in knee proprioception and muscle activation. ,"['35 healthy male amateur runners', 'Healthy Individuals', 'healthy people within short periods', 'healthy participants']","[' : Kinesiology taping (KT', 'CON-TREX isokinetic dynamometer', 'Short-Term Kinesiology Taping', 'KT', 'no taping, placebo taping, KT with tension, and KT with no tension']","['knee proprioception and muscle activation', 'muscle activation and proprioception of knee', 'knee proprioception and quadriceps performance', 'Knee Proprioception and Quadriceps Performance']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425946', 'cui_str': 'Short menstrual periods'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0233494', 'cui_str': 'Tension'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",35.0,0.0309153,No significant interaction and no significant differences between groups and time effects in knee proprioception and muscle activation. ,"[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Xiao-Xi', 'Initials': 'XX', 'LastName': 'Wang', 'Affiliation': ""Tangshan People's Hospital, Tangshan, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}]",Frontiers in physiology,['10.3389/fphys.2020.603193']
2453,33262641,Tolperisone for the Treatment of Acute Muscle Spasm of the Back: Results from the Dose-Ranging Phase 2 STAR Study (NCT03802565).,"Objective
Use of skeletal muscle relaxants (SMRs) for acute muscle spasm is confounded by central nervous system adverse events (AEs), including somnolence. Tolperisone is an SMR that does not appear to be associated with somnolence. The aim of this study was to assess the safety and efficacy of tolperisone versus placebo in subjects with acute muscle spasm of the back.
Methods
STAR (NCT03802565) was a double-blind, randomized, placebo-controlled phase 2 study in subjects with back pain due to acute muscle spasm. Subjects were randomized 1:1:1:1:1 to tolperisone 50, 100, 150, or 200 mg three times daily (TID) or placebo for 14 days. The primary efficacy endpoint was subject-rated pain ""right now"" using a numeric rating scale on day 14.
Results
Subjects (tolperisone, n=337; placebo, n=78) were enrolled at 38 US clinical sites. Tolperisone was well tolerated, with AEs in 18.1% of subjects receiving tolperisone versus 14.1% of subjects receiving placebo. Headache (7.1%) and diarrhea (2.4%) were the most frequent AEs in tolperisone-treated subjects versus 3.8% and 0%, respectively, in placebo-treated subjects. Somnolence was reported in 1.2% and 2.6% of subjects treated with tolperisone and placebo, respectively. Mean change from baseline in numeric rating scale score of pain ""right now"" on day 14 was -3.5 for placebo versus -4.2, -4.0, -3.7, and -4.4 for tolperisone 50, 100, 150, and 200 mg TID, respectively (linear test of trend on the least-squares mean difference [treatment-placebo]; p=0.0539). In an analysis of pairwise estimates (treatment-placebo), the greatest numerical difference and significance were observed for tolperisone 200 mg TID (p=0.0040). Several secondary endpoints trended toward significance for tolperisone 200 mg TID versus placebo.
Conclusion
Tolperisone 200 mg TID may be a promising treatment for acute muscle spasm, without the somnolence associated with SMRs. The safety and efficacy of tolperisone should be evaluated in a phase 3 trial.",2020,"Mean change from baseline in numeric rating scale score of pain ""right now"" on day 14 was -3.5 for placebo versus -4.2, -4.0, -3.7, and -4.4 for tolperisone 50, 100, 150, and 200 mg TID, respectively (linear test of trend on the least-squares mean difference [treatment-placebo]; p=0.0539).","['Results\n\n\nSubjects (tolperisone, n=337; placebo, n=78) were enrolled at 38 US clinical sites', 'subjects with back pain due to acute muscle spasm', 'subjects with acute muscle spasm of the back', 'Acute Muscle Spasm of the Back']","['tolperisone and placebo', 'placebo', 'skeletal muscle relaxants (SMRs', 'tolperisone', 'Tolperisone', 'tolperisone versus placebo']","['subject-rated pain ""right now"" using a numeric rating scale on day 14', 'safety and efficacy', 'Somnolence', 'numeric rating scale score of pain ""right now', 'Headache', 'tolerated', 'diarrhea']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}]","[{'cui': 'C0040382', 'cui_str': 'Tolperisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037250', 'cui_str': 'Skeletal muscle relaxant'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",78.0,0.345461,"Mean change from baseline in numeric rating scale score of pain ""right now"" on day 14 was -3.5 for placebo versus -4.2, -4.0, -3.7, and -4.4 for tolperisone 50, 100, 150, and 200 mg TID, respectively (linear test of trend on the least-squares mean difference [treatment-placebo]; p=0.0539).","[{'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Nalamachu', 'Affiliation': 'Mid America PolyClinic, Overland Park, KS, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pergolizzi', 'Affiliation': 'NEMA Research, Naples, FL, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Kaye', 'Affiliation': 'Neurana Pharmaceuticals, Inc., San Diego, CA, USA.'}]",Journal of pain research,['10.2147/JPR.S278857']
2454,33262584,"High-Flow Nasal Cannula for Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure: A Randomized, Controlled Trial.","Introduction
Currently, there is a lack of evidence on the utilization of high-flow nasal cannula (HFNC) in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) accompanied by hypercapnic respiratory failure. We aimed to explore the efficacy and safety of HFNC compared with conventional oxygen therapy (COT) in such patients.
Methods
This was a prospective, randomized, controlled trial. Patients with AECOPD with a baseline arterial blood gas pH ≥7.35, PaO 2 <60 mmHg, and PaCO 2 >45 mmHg were enrolled. The primary endpoint was treatment failure, which needs mechanical ventilation.
Results
A total of 320 patients were randomized to either the HFNC group (n = 160) or the COT group (n = 160). Sixteen (10.0%) patients in the HFNC group had treatment failure during hospitalization, which was significantly lower than the COT group figure of 31 (19.4%) patients ( p = 0.026). Twenty-four hours after recruitment, the PaCO 2 of the HFNC group was lower than that of the COT group (54.1 ± 9.79 mmHg vs 56.9 ± 10.1 mmHg, p = 0.030). PaCO 2 higher than 59 mmHg after HFNC for 24 h was identified as an independent risk factor for treatment failure [OR 1.078, 95% CI 1.006-1.154, p = 0.032].
Conclusion
In AECOPD patients with acute compensated hypercapnic respiratory failure, HFNC improved the prognosis compared with COT. Therefore, HFNC might be considered for first-line oxygen therapy in select patients.
Trial Registration Number
ClinicalTrials.Gov: NCT02439333.",2020,"PaCO 2 higher than 59 mmHg after HFNC for 24 h was identified as an independent risk factor for treatment failure [OR 1.078, 95% CI 1.006-1.154, p = 0.032].
","['320 patients', 'patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) accompanied by hypercapnic respiratory failure', 'Patients with AECOPD with a baseline arterial blood gas pH ≥7.35, PaO 2 <60 mmHg, and PaCO 2', '45 mmHg were enrolled', 'such patients', 'Chronic Obstructive Pulmonary Disease with Acute Compensated Hypercapnic Respiratory Failure']","['COT', 'HFNC', 'conventional oxygen therapy (COT', 'High-Flow Nasal Cannula']","['treatment failure, which needs mechanical ventilation', 'efficacy and safety', 'treatment failure during hospitalization']","[{'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",320.0,0.338603,"PaCO 2 higher than 59 mmHg after HFNC for 24 h was identified as an independent risk factor for treatment failure [OR 1.078, 95% CI 1.006-1.154, p = 0.032].
","[{'ForeName': 'Xu-Yan', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Hai-Chao', 'Initials': 'HC', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Hui-Wen', 'Initials': 'HW', 'LastName': 'Chu', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital-West Branch, Beijing, People's Republic of China.""}, {'ForeName': 'Wen-Ping', 'Initials': 'WP', 'LastName': 'Mao', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital-West Branch, Beijing, People's Republic of China.""}, {'ForeName': 'Yu-Jun', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Huai-Rou Hospital of University of Chinese Academy of Science, Beijing, People's Republic of China.""}, {'ForeName': 'Zhan-Hong', 'Initials': 'ZH', 'LastName': 'Tian', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Huai-Rou Hospital of University of Chinese Academy of Science, Beijing, People's Republic of China.""}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Huai-Rou Hospital of University of Chinese Academy of Science, Beijing, People's Republic of China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': ""Department of Respiratory Neurology, Cancer Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Zhao-Hui', 'Initials': 'ZH', 'LastName': 'Tong', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, People's Republic of China.""}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S283020']
2455,33270577,COMBINED TREATMENT WITH FOCUSED LOW-INTENSITY SHOCK-WAVE THERAPY AND ANDROGEN-STIMULATION THERAPY IN MEN WITH CORPORAL VENO-OCCLUSIVE ERECTILE DYSFUNCTION ON THE BACKGROUND OF HYPOGONADOTROPIC HYPOGONADISM.,"Aim - to evaluate efficacy of focused low-intensity shock-wave therapy and androgen-stimulation therapy combination in men with corporal veno-oclusive erectile dysfunction on the background of hypogonadotropic hypogonadism. A prospective clinical study was conducted on a contingent of 42 patients of ""Man's Health Clinic"" (Kiev, Ukraine) suffering from moderate corporal veno-oclusive erectile dysfunction on the background of hypogonadotropic hypogonadism. Study contingent was randomized on two groups. MG - 22 patients who underwent 2 component therapy model: ChG, focused LISWT and ICA . CG - 20 patients who underwent CG and ICA treatment (same as MG) but without LISWT. Clinical efficacy was evaluated by difference between initial and follow up data. Significant differences was found in IIEF-5and AMS results distribution both in MG and CG (p≤0,01). For pharmacodoppler-sonography data significant difference was found only for EDV in MG (p≤0,05). For serum testosterone levels difference is also significant in both groups (p≤0,01). By quantitative data analysis it was found that EDV in MG is significantly lower than in CG (p≤0,05). Thus, addition of focused LISWT into therapeutic model for corporal veno-oclusive erectile dysfunction on the background of hypogonadotropic hypogonadism is absolutely beneficial due to more effective correction of venous leakage. Treatment model that combines focused low-intensity shock-wave therapy and androgen-stimulation therapy in men with corporal veno-oclusive erectile dysfunction on the background of hypogonadotropic hypogonadism had shown its efficacy in 6 month follow-up study according to IIEF-5 and AMS data (p≤0,01), pharmacodoppler-sonography data - mean EDV (p≤0,05) in stimulation and serum testosterone levels correction (p≤0,01). Addition of focused low-intensity shock-wave therapy showed better results for erectile dysfunction correction in decreasing number of moderate erectile dysfunction cases (p≤0,05) and EDV decrease (p≤0,05).",2020,"Significant differences was found in IIEF-5and AMS results distribution both in MG and CG (p≤0,01).","['men with corporal veno-oclusive erectile dysfunction', ' 22 patients who underwent 2 component therapy model: ChG, focused LISWT and ICA ', 'men with corporal veno-oclusive erectile dysfunction on the background of hypogonadotropic hypogonadism', '42 patients of ""Man\'s Health Clinic"" (Kiev, Ukraine) suffering from moderate corporal veno-oclusive erectile dysfunction on the background of hypogonadotropic hypogonadism']","['low-intensity shock-wave therapy', 'MG', 'CG and ICA', 'low-intensity shock-wave therapy and androgen-stimulation therapy combination', 'combines focused low-intensity shock-wave therapy and androgen-stimulation therapy']","['serum testosterone levels difference', 'Clinical efficacy']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0008586', 'cui_str': 'Chromogranin'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0201519', 'cui_str': 'Islet cell antibody measurement'}, {'cui': 'C0022735', 'cui_str': 'Klinefelter syndrome'}, {'cui': 'C1456606', 'cui_str': ""Men's Health""}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0041580', 'cui_str': 'Ukraine'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0201519', 'cui_str': 'Islet cell antibody measurement'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",42.0,0.021579,"Significant differences was found in IIEF-5and AMS results distribution both in MG and CG (p≤0,01).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zasieda', 'Affiliation': '""Men\'s Health Clinic"", Kiev, Ukraine.'}]",Georgian medical news,[]
2456,33270575,[A COMPARISON OF RESULTS BETWEEN HOOK PLATE AND TIGHTROPE FOR ACUTE ACROMIOCLAVICULAR JOINT DISLOCATION].,"Purpose the study - despite of this fact that there are different surgical techniques to treat acromioclavicular dislocation and also the surgery remains controversial, the purpose of our study is to compare the results of surgery treatment to acromioclavicular joint dislocation on the condition of surgical method: Hook Plate versus TightRope. Between 2015 and 2019, 30 patients were with acute Rockwood type III-VI acromioclavicular dislocation at the age of 23-54. Patients were divided into 2 groups according to the surgical methods (Hook plate: n=15; TightRope: n=15)to compare the functional outcome after using either Hook plate and TightRope stabilization. Patients were evaluated using Constant Score and radiography. Comparing the functional results, were observed some differences between the two groups. According to Constant Score the results were: Hook plate - 78.5, TightRope - 81.4. 14 patients in the hook plate group were reoperated to remove the device, except 1 patient who refused to be reoperated. There was insignificant difference between both groups regarding severity pain. The majority of tightrope group (70%) regained their normal functional activities, whereas only 40% of the hook plate patients did (р<0.001)/ About half (50%) of the tightrope group in comparison with 30% of hook plate group had active forward flexion more than 150° (р<0.01). Both groups showed no significant differences regarding degree of muscle strength, patients' satisfaction, and total outcome. Both operative methods are effective techniques and could be recommended to treat an acute acromioclavicular joint dislocation. Between the two groups are no significant differences. However, TightRope fixation provides a low rate of failure and complications and avoids the need for second surgery to remove the implant.",2020,"Both groups showed no significant differences regarding degree of muscle strength, patients' satisfaction, and total outcome.","['14 patients in the hook plate group', 'HOOK PLATE AND TIGHTROPE FOR ACUTE ACROMIOCLAVICULAR JOINT DISLOCATION', 'Between 2015 and 2019, 30 patients were with acute Rockwood type III-VI acromioclavicular dislocation at the age of 23-54']","['Hook plate and TightRope stabilization', 'surgical methods (Hook plate', 'TightRope fixation']","[""muscle strength, patients' satisfaction, and total outcome"", 'active forward flexion', 'normal functional activities', 'severity pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0181209', 'cui_str': 'Hook'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0149820', 'cui_str': 'Dislocation of acromioclavicular joint'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0181209', 'cui_str': 'Hook'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.0198142,"Both groups showed no significant differences regarding degree of muscle strength, patients' satisfaction, and total outcome.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Grigorev', 'Affiliation': ""Moscow City Clinical Hospital named after V.M. Buyanov; Peoples' Friendship University of Russia, Moscow, Russia.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lazko', 'Affiliation': ""Moscow City Clinical Hospital named after V.M. Buyanov; Peoples' Friendship University of Russia, Moscow, Russia.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Prizov', 'Affiliation': ""Moscow City Clinical Hospital named after V.M. Buyanov; Peoples' Friendship University of Russia, Moscow, Russia.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanaev', 'Affiliation': ""Moscow City Clinical Hospital named after V.M. Buyanov; Peoples' Friendship University of Russia, Moscow, Russia.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lazko', 'Affiliation': ""Moscow City Clinical Hospital named after V.M. Buyanov; Peoples' Friendship University of Russia, Moscow, Russia.""}]",Georgian medical news,[]
2457,33270570,EFFECTS OF NUTRITIONAL TREATMENT ON THE QUALITY OF LIFE IN THE PATIENTS AFTER RADICAL SURGERY FOR COLON CANCER.,"Malnutrition is one of the complications following surgical resection of the colon. Aim - to study the impact of enteral nutritional supplements and high-calorie diet on to nutritional status and quality of life within 12 months after surgical treatment. 220 patients after surgery of the colon cancer are divided into 3 groups: group 1 (G1 n=68) - enteral nutrition, group 2 (G2 n=64) - high-calorie diet, group 3 (G3 n=88) - patients with baseline high PNI, follow-up. Nutritional status, NRS-2002 and EORTC QLQ C 30 questionnaire were analyzed. In G1 there was an increase in body weight, BMI and improvement of laboratory parameters compared with G2, where body weight, BMI and laboratory parameters remained unchanged (p˂0.03). In G3 there was a decrease in body weight, BMI and a deterioration in blood counts (p˃0.06). In G1, functional indicators of quality of life were improved (p˂0.002), which had a positive correlation with nutrition indicators (p˂0.05). In G2, an improvement in 3 functional scales (p˂0.003), but not as significant as in G1. In G3 deterioration of all functional and symptomatic scales that had a close correlation with malnutrition (p˂0.05). Special enteral nutrition had a more positive effect on the nutritional status and quality of life than a high-calorie diet. Also, despite the initial high PNI and the lack of malnutrition in the preoperative period, the majority of patients 1 year after surgery are subject to the development of malnutrition.",2020,"In G3 there was a decrease in body weight, BMI and a deterioration in blood counts (p˃0.06).",['220 patients after surgery of the colon cancer'],"['enteral nutrition, group 2 (G2 n=64) - high-calorie diet, group 3 (G3 n=88) - patients with baseline high PNI, follow-up', 'enteral nutritional supplements and high-calorie diet', 'Special enteral nutrition']","['body weight, BMI and a deterioration in blood counts', 'body weight, BMI and laboratory parameters', 'Nutritional status, NRS-2002 and EORTC QLQ C 30 questionnaire', 'body weight, BMI and improvement of laboratory parameters', 'nutritional status and quality of life', '3 functional scales', 'quality of life']","[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0301590', 'cui_str': 'Increased calorie diet'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",220.0,0.0178155,"In G3 there was a decrease in body weight, BMI and a deterioration in blood counts (p˃0.06).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bekisheva', 'Affiliation': 'Astana Medical University, Nur-Sultan, Kazakhstan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makishev', 'Affiliation': 'Astana Medical University, Nur-Sultan, Kazakhstan.'}]",Georgian medical news,[]
2458,33270531,Anticipation of Historical Exercise Patterns by a Novel Artificial Pancreas System Reduces Hypoglycemia During and After Moderate-Intensity Physical Activity in People with Type 1 Diabetes.,"Objective: Physical activity is a major challenge to glycemic control for people with type 1 diabetes. Moderate-intensity exercise often leads to steep decreases in blood glucose and hypoglycemia that closed-loop control systems have so far failed to protect against, despite improving glycemic control overall. Research Design and Methods: Fifteen adults with type 1 diabetes (42 ± 13.5 years old; hemoglobin A 1c 6.6% ± 1.0%; 10F/5M) participated in a randomized crossover clinical trial comparing two hybrid closed-loop (HCL) systems, a state-of-the-art hybrid model predictive controller and a modified system designed to anticipate and detect unannounced exercise (APEX), during two 32-h supervised admissions with 45 min of planned moderate activity, following 4 weeks of data collection. Primary outcome was the number of hypoglycemic episodes during exercise. Continuous glucose monitor (CGM)-based metrics and hypoglycemia are also reported across the entire admissions. Results: The APEX system reduced hypoglycemic episodes overall (9 vs. 33; P = 0.02), during exercise (5 vs. 13; P = 0.04), and in the 4 h following (2 vs. 11; P = 0.02). Overall CGM median percent time <70 mg/dL decreased as well (0.3% vs. 1.6%; P = 0.004). This protection was obtained with no significant increase in time >180 mg/dL (18.5% vs. 16.6%, P = 0.15). Overnight control was notable for both systems with no hypoglycemia, median percent in time 70-180 mg/dL at 100% and median percent time 70-140 mg/dL at ∼96% for both. Conclusions: A new closed-loop system capable of anticipating and detecting exercise was proven to be safe and feasible and outperformed a state-of-the-art HCL, reducing participants' exposure to hypoglycemia during and after moderate-intensity physical activity. ClinicalTrials.gov NCT03859401.",2020,"The APEX system reduced hypoglycemic episodes overall (9 vs. 33; P = 0.02), during exercise (5 vs. 13; P = 0.04), and in the 4 h following (2 vs. 11; P = 0.02).","['People with Type 1 Diabetes', 'people with type 1 diabetes', 'Fifteen adults with type 1 diabetes (42\u2009±\u200913.5 years old; hemoglobin A 1c 6.6%\u2009±\u20091.0%; 10F/5M']","['hybrid closed-loop (HCL) systems, a state-of-the-art hybrid model predictive controller and a modified system designed to anticipate and detect unannounced exercise (APEX']","['Overall CGM median percent time', 'Hypoglycemia', 'blood glucose and hypoglycemia', 'number of hypoglycemic episodes during exercise', 'hypoglycemic episodes overall', 'Continuous glucose monitor (CGM)-based metrics and hypoglycemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0443183', 'cui_str': 'Closed loop'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycaemic episode'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",15.0,0.0813965,"The APEX system reduced hypoglycemic episodes overall (9 vs. 33; P = 0.02), during exercise (5 vs. 13; P = 0.04), and in the 4 h following (2 vs. 11; P = 0.02).","[{'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Garcia-Tirado', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Sue A', 'Initials': 'SA', 'LastName': 'Brown', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Nitchakarn', 'Initials': 'N', 'LastName': 'Laichuthai', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Colmegna', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Chaitanya L K', 'Initials': 'CLK', 'LastName': 'Koravi', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Ozaslan', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Corbett', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Barnett', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pajewski', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Oliveri', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Myers', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}, {'ForeName': 'Marc D', 'Initials': 'MD', 'LastName': 'Breton', 'Affiliation': 'Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.'}]",Diabetes technology & therapeutics,['10.1089/dia.2020.0516']
2459,33275152,Frequency and Risk Factors of Acute Kidney Injury During Diabetic Ketoacidosis in Children and Association With Neurocognitive Outcomes.,"Importance
Acute kidney injury (AKI) occurs commonly during diabetic ketoacidosis (DKA) in children, but the underlying mechanisms and associations are unclear.
Objective
To investigate risk factors for AKI and its association with neurocognitive outcomes in pediatric DKA.
Design, Setting, and Participants
This cohort study was a secondary analysis of data from the Pediatric Emergency Care Applied Research Network Fluid Therapies Under Investigation in DKA Study, a prospective, multicenter, randomized clinical trial comparing fluid protocols for pediatric DKA in 13 US hospitals. Included DKA episodes occurred among children age younger than 18 years with blood glucose 300 mg/dL or greater and venous pH less than 7.25 or serum bicarbonate level less than 15 mEq/L.
Exposures
DKA requiring intravenous insulin therapy.
Main Outcomes and Measures
AKI occurrence and stage were assessed using serum creatinine measurements using Kidney Disease: Improving Global Outcomes criteria. DKA episodes with and without AKI were compared using univariable and multivariable methods, exploring associated factors.
Results
Among 1359 DKA episodes (mean [SD] patient age, 11.6 [4.1] years; 727 [53.5%] girls; 651 patients [47.9%] with new-onset diabetes), AKI occurred in 584 episodes (43%; 95% CI, 40%-46%). A total of 252 AKI events (43%; 95% CI, 39%-47%) were stage 2 or 3. Multivariable analyses identified older age (adjusted odds ratio [AOR] per 1 year, 1.05; 95% CI, 1.00-1.09; P = .03), higher initial serum urea nitrogen (AOR per 1 mg/dL increase, 1.14; 95% CI, 1.11-1.18; P < .001), higher heart rate (AOR for 1-SD increase in z-score, 1.20; 95% CI, 1.09-1.32; P < .001), higher glucose-corrected sodium (AOR per 1 mEq/L increase, 1.03; 95% CI, 1.00-1.06; P = .001) and glucose concentrations (AOR per 100 mg/dL increase, 1.19; 95% CI, 1.07-1.32; P = .001), and lower pH (AOR per 0.1 increase, 0.63; 95% CI, 0.51-0.78; P < .001) as variables associated with AKI. Children with AKI, compared with those without, had lower scores on tests of short-term memory during DKA (mean [SD] digit span recall: 6.8 [2.4] vs 7.6 [2.2]; P = .02) and lower mean (SD) IQ scores 3 to 6 months after recovery from DKA (100.0 [12.2] vs 103.5 [13.2]; P = .005). Differences persisted after adjusting for DKA severity and demographic factors, including socioeconomic status.
Conclusions and Relevance
These findings suggest that AKI may occur more frequently in children with greater acidosis and circulatory volume depletion during DKA and may be part of a pattern of multiple organ injury involving the kidneys and brain.",2020,"Multivariable analyses identified older age (adjusted odds ratio [AOR] per 1 year, 1.05; 95% CI, 1.00-1.09; P = .03), higher initial serum urea nitrogen (AOR per 1 mg/dL increase, 1.14; 95% CI, 1.11-1.18; P < .001), higher heart rate (AOR for 1-SD increase in z-score, 1.20; 95% CI, 1.09-1.32; P < .001), higher glucose-corrected sodium (AOR per 1 mEq/L increase, 1.03; 95% CI, 1.00-1.06; P = .001) and glucose concentrations (AOR per 100 mg/dL increase, 1.19; 95% CI, 1.07-1.32; P = .001), and lower pH (AOR per 0.1 increase, 0.63; 95% CI, 0.51-0.78; P < .001) as variables associated with AKI.","['Acute Kidney Injury', 'children age younger than 18 years with blood glucose 300 mg/dL or greater and venous pH less than 7.25 or serum bicarbonate level less than 15 mEq/L.\nExposures\n\n\nDKA requiring intravenous insulin therapy', 'pediatric DKA in 13 US hospitals']",[],"['higher glucose-corrected sodium', 'glucose concentrations', 'higher initial serum urea nitrogen', 'heart rate']","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0439375', 'cui_str': 'mEq/L'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0856666', 'cui_str': 'Serum urea'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",,0.256947,"Multivariable analyses identified older age (adjusted odds ratio [AOR] per 1 year, 1.05; 95% CI, 1.00-1.09; P = .03), higher initial serum urea nitrogen (AOR per 1 mg/dL increase, 1.14; 95% CI, 1.11-1.18; P < .001), higher heart rate (AOR for 1-SD increase in z-score, 1.20; 95% CI, 1.09-1.32; P < .001), higher glucose-corrected sodium (AOR per 1 mEq/L increase, 1.03; 95% CI, 1.00-1.06; P = .001) and glucose concentrations (AOR per 100 mg/dL increase, 1.19; 95% CI, 1.07-1.32; P = .001), and lower pH (AOR per 0.1 increase, 0.63; 95% CI, 0.51-0.78; P < .001) as variables associated with AKI.","[{'ForeName': 'Sage R', 'Initials': 'SR', 'LastName': 'Myers', 'Affiliation': ""Division of Emergency Medicine, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Nicole S', 'Initials': 'NS', 'LastName': 'Glaser', 'Affiliation': 'Department of Pediatrics, University of California, Davis School of Medicine, Sacramento.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Trainor', 'Affiliation': ""Division of Emergency Medicine, Ann and Robert H. Lurie Children's Hospital, Chicago, Illinois.""}, {'ForeName': 'Lise E', 'Initials': 'LE', 'LastName': 'Nigrovic', 'Affiliation': ""Division of Emergency Medicine, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Aris', 'Initials': 'A', 'LastName': 'Garro', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital, Providence.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Tzimenatos', 'Affiliation': 'Department of Emergency Medicine, University of California, Davis School of Medicine, Sacramento.'}, {'ForeName': 'Kimberly S', 'Initials': 'KS', 'LastName': 'Quayle', 'Affiliation': ""Division of Emergency Medicine, St Louis Children's Hospital, St Louis, Missouri.""}, {'ForeName': 'Maria Y', 'Initials': 'MY', 'LastName': 'Kwok', 'Affiliation': ""Division of Emergency Medicine, NewYork-Presbyterian Morgan Stanley Children's Hospital, New York.""}, {'ForeName': 'Arleta', 'Initials': 'A', 'LastName': 'Rewers', 'Affiliation': ""Division of Emergency Medicine, Colorado Children's Hospital, Denver.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Stoner', 'Affiliation': ""Division of Emergency Medicine, Nationwide Children's Hospital, Columbus, Ohio.""}, {'ForeName': 'Jeff E', 'Initials': 'JE', 'LastName': 'Schunk', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'McManemy', 'Affiliation': ""Division of Emergency Medicine, Texas Children's Hospital, Houston.""}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Brown', 'Affiliation': ""Division of Emergency Medicine, Children's National Medical Center, Washington, District of Columbia.""}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'DePiero', 'Affiliation': 'Division of Emergency Medicine, Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware.'}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah School of Medicine, Salt Lake City.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ghetti', 'Affiliation': 'Department of Psychology, UC Davis Health, University of California School of Medicine, Sacramento.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Kuppermann', 'Affiliation': 'Department of Pediatrics, University of California, Davis School of Medicine, Sacramento.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.25481']
2460,33275151,Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial.,"Importance
Catheter ablation is effective in reducing atrial fibrillation (AF), but the association of ablation for AF with quality of life is unclear.
Objective
To evaluate whether the procedural outcome of ablation for AF is associated with quality of life (QOL) measures.
Design, Setting, and Participants
This was a prespecified secondary analysis of the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation-Part II (STAR AF II) prospective randomized clinical trial, which compared 3 strategies for ablation of persistent AF. This analysis included 549 of the 589 patients enrolled in the trial who underwent ablation. Enrollment occurred at 35 centers in Europe, Canada, Australia, China, and Korea from November 2010 to July 2012. Data for the current study were analyzed on December 11, 2019.
Interventions
Patients underwent AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions.
Main Outcomes and Measures
Quality of life was assessed at baseline and at 6, 12, and 18 months after ablation for AF using the 36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire. Scores were also converted to a physical health component score (PCS) and a mental health component score (MCS). Individual AF burden was calculated by the total time with AF from Holter monitors and the percentage of transtelephonic monitor recordings showing AF.
Results
Among the 549 patients included in this secondary analysis, QOL was assessed in 466 (85%) at baseline and at 6, 12, and 18 months after ablation for AF. The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation. The AF burden significantly decreased from a mean (SD) of 82% (36%) before ablation to 6.6% (23%) after ablation (P < .001). Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P < .05 for both). Significant QOL improvement occurred in all 3 study arms and regardless of AF recurrence, defined as AF episodes lasting more than 30 seconds: for no recurrence, mean (SD) PCS increased from 66.5 (20.9) to 79.1 (19.4) and MCS from 35.3 (8.7) to 37.7 (7.7); for recurrence, mean (SD) PCS increased from 70.2 (20.4) to 86.4 (16.8) and MCS from 35.3 (8.6) to 37.1 (7.4) (P < .05 for all). When outcome was defined by AF burden reduction, in patients with less than 70% reduction in AF burden, the increase in PCS was significantly less than in those with greater than 70% reduction, and only 3 of 8 subscales showed significant improvement.
Conclusions and Relevance
In this secondary analysis, decreases in AF burden after ablation for AF were significantly associated with improvements in QOL. Quality of life changes were significantly associated with the percentage of AF burden reduction after ablation.
Trial Registration
ClinicalTrials.gov Identifier: NCT01203748.",2020,Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P < .05 for both).,"['549 patients', 'Atrial Fibrillation', 'The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation', '549 of the 589 patients enrolled in the trial who underwent ablation']","['Catheter ablation', 'Catheter Ablation', 'AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions']","['Quality of Life and Procedural Outcome', 'recurrence, mean (SD) PCS', 'PCS', 'Quality of life changes', 'Individual AF burden', 'Measures\n\n\nQuality of life', 'QOL', 'mean (SD) PCS', 'MCS', 'quality of life (QOL) measures', 'physical health component score (PCS) and a mental health component score (MCS', '36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire', 'Significant QOL improvement', 'AF burden', 'AF recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750502', 'cui_str': 'Significant'}]",589.0,0.060372,Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P < .05 for both).,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Terricabras', 'Affiliation': 'Department of Cardiology, Southlake Regional Health Centre, University of Toronto, Newmarket, Ontario, Canada.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mantovan', 'Affiliation': 'Department of Cardiology, Santa Maria dei Battuti Hospital, Conegliano, Italy.'}, {'ForeName': 'Chen-Yang', 'Initials': 'CY', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, Sir Run Shaw Hospital, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Betts', 'Affiliation': 'Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Deisenhofer', 'Affiliation': 'German Heart Center, Munich, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Department of Cardiology, Foothills Medical Centre, Calgary, Alberta, Canada.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Cardiology, Campus Virchow-Klinikum, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Rukshen', 'Initials': 'R', 'LastName': 'Weerasooriya', 'Affiliation': 'Department of Cardiology, Hollywood Private Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Albenque', 'Affiliation': 'Department of Cardiology, Clinique Pasteur Toulouse, Toulouse, France.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nardi', 'Affiliation': 'Department of Cardiology, Pineta Grande Hospital, Castel Volturno, Italy.'}, {'ForeName': 'Endrj', 'Initials': 'E', 'LastName': 'Menardi', 'Affiliation': 'Department of Cardiology, Santa Croce e Carle Hospital, Cuneo, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Department of Cardiology, Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Department of Cardiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Cardiology, Southlake Regional Health Centre, University of Toronto, Newmarket, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.25473']
2461,33275134,Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial.,"Importance
Influenza is temporally associated with cardiopulmonary morbidity and mortality among those with cardiovascular disease who may mount a less vigorous immune response to vaccination. Higher influenza vaccine dose has been associated with reduced risk of influenza illness.
Objective
To evaluate whether high-dose trivalent influenza vaccine compared with standard-dose quadrivalent influenza vaccine would reduce all-cause death or cardiopulmonary hospitalization in high-risk patients with cardiovascular disease.
Design, Setting, and Participants
Pragmatic multicenter, double-blind, active comparator randomized clinical trial conducted in 5260 participants vaccinated for up to 3 influenza seasons in 157 sites in the US and Canada between September 21, 2016, and January 31, 2019. Patients with a recent acute myocardial infarction or heart failure hospitalization and at least 1 additional risk factor were eligible.
Interventions
Participants were randomly assigned to receive high-dose trivalent (n = 2630) or standard-dose quadrivalent (n = 2630) inactivated influenza vaccine and could be revaccinated for up to 3 seasons.
Main Outcomes and Measures
The primary outcome was the time to the composite of all-cause death or cardiopulmonary hospitalization during each enrolling season. The final date of follow-up was July 31, 2019. Vaccine-related adverse events were also assessed.
Results
Among 5260 randomized participants (mean [SD] age, 65.5 [12.6] years; 3787 [72%] men; 3289 [63%] with heart failure) over 3 influenza seasons, there were 7154 total vaccinations administered and 5226 (99.4%) participants completed the trial. In the high-dose trivalent vaccine group, there were 975 primary outcome events (883 hospitalizations for cardiovascular or pulmonary causes and 92 deaths from any cause) among 884 participants during 3577 participant-seasons (event rate, 45 per 100 patient-years), whereas in the standard-dose quadrivalent vaccine group, there were 924 primary outcome events (846 hospitalizations for cardiovascular or pulmonary causes and 78 deaths from any cause) among 837 participants during 3577 participant-seasons (event rate, 42 per 100 patient-years) (hazard ratio, 1.06 [95% CI, 0.97-1.17]; P = .21). In the high-dose vs standard-dose groups, vaccine-related adverse reactions occurred in 1449 (40.5%) vs 1229 (34.4%) participants and severe adverse reactions occurred in 55 (2.1%) vs 44 (1.7%) participants.
Conclusions and Relevance
In patients with high-risk cardiovascular disease, high-dose trivalent inactivated influenza vaccine, compared with standard-dose quadrivalent inactivated influenza vaccine, did not significantly reduce all-cause mortality or cardiopulmonary hospitalizations. Influenza vaccination remains strongly recommended in this population.
Trial Registration
ClinicalTrials.gov Identifier: NCT02787044.",2020,"In the high-dose trivalent vaccine group, there were 975 primary outcome events (883 hospitalizations for cardiovascular or pulmonary causes and 92 deaths from any cause) among 884 participants during 3577 participant-seasons (event rate, 45 per 100 patient-years), whereas in the standard-dose quadrivalent vaccine group, there were 924 primary outcome events (846 hospitalizations for cardiovascular or pulmonary causes and 78 deaths from any cause) among 837 participants during 3577 participant-seasons (event rate, 42 per 100 patient-years) (hazard ratio, 1.06 [95% CI, 0.97-1.17]; P = .21).","['5260 participants vaccinated for up to 3 influenza seasons in 157 sites in the US and Canada between September 21, 2016, and January 31, 2019', 'Patients with a recent acute myocardial infarction or heart failure hospitalization and at least 1 additional risk factor were eligible', 'Patients With High-risk Cardiovascular Disease', 'high-risk patients with cardiovascular disease', '5260 randomized participants (mean [SD] age, 65.5 [12.6] years; 3787 [72%] men; 3289 [63%] with heart failure) over 3 influenza seasons, there were 7154 total vaccinations administered and 5226', 'patients with high-risk cardiovascular disease']","['standard-dose quadrivalent influenza vaccine', 'high-dose trivalent influenza vaccine', 'high-dose trivalent (n\u2009=\u20092630) or standard-dose quadrivalent (n\u2009=\u20092630) inactivated influenza vaccine and could be revaccinated for up to 3 seasons', 'High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine']","['Mortality or Cardiopulmonary Hospitalization', 'severe adverse reactions', 'hospitalizations for cardiovascular or pulmonary causes and 92 deaths from any cause', 'time to the composite of all-cause death or cardiopulmonary hospitalization', 'hospitalizations for cardiovascular or pulmonary causes and 78 deaths', 'adverse reactions', 'adverse events']","[{'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C4505396', 'cui_str': 'High-Dose Trivalent Influenza Vaccine'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",5260.0,0.447447,"In the high-dose trivalent vaccine group, there were 975 primary outcome events (883 hospitalizations for cardiovascular or pulmonary causes and 92 deaths from any cause) among 884 participants during 3577 participant-seasons (event rate, 45 per 100 patient-years), whereas in the standard-dose quadrivalent vaccine group, there were 924 primary outcome events (846 hospitalizations for cardiovascular or pulmonary causes and 78 deaths from any cause) among 837 participants during 3577 participant-seasons (event rate, 42 per 100 patient-years) (hazard ratio, 1.06 [95% CI, 0.97-1.17]; P = .21).","[{'ForeName': 'Orly', 'Initials': 'O', 'LastName': 'Vardeny', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Udell', 'Affiliation': ""Peter Munk Cardiac Centre, University Health Network, Women's College Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Joseph', 'Affiliation': 'Department of Medicine, Boston VA, Boston, Massachusetts.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Hegde', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'McGeer', 'Affiliation': 'Sinai Health System, University of Toronto, Toronto, Canada.'}, {'ForeName': 'H Keipp', 'Initials': 'HK', 'LastName': 'Talbot', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Gaziano', 'Affiliation': 'Department of Medicine, Boston VA, Boston, Massachusetts.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Nichol', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Tattersall', 'Affiliation': 'Department of Medicine, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Temte', 'Affiliation': 'Department of Family Medicine, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative Inc, Washington, DC.'}, {'ForeName': 'Clyde', 'Initials': 'C', 'LastName': 'Yancy', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Claggett', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Havighurst', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.23649']
2462,33275115,The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND
University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support.
OBJECTIVE
The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students.
METHODS
This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program.
RESULTS
The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes.
CONCLUSIONS
The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students.
TRIAL REGISTRATION
Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/21307.",2020,This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control.,"['A total of 70 participants were recruited to the trial', '70 university students who do not present with a clinical mental health disorder', 'university students', 'University students', 'vulnerable university students', 'Australian university students', 'Australian University Students', 'engage university students']","['self-directed web-based CBT mental health program with a waitlist control', 'web-based mental health program', 'existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program']","['rate of seeking mental health treatment', 'acceptability, feasibility, safety, and efficacy', 'feasibility, acceptability, safety, and efficacy', 'feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress', 'psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184647', 'cui_str': 'Mental health treatment'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1522240', 'cui_str': 'Process'}]",70.0,0.156081,This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control.,"[{'ForeName': 'Karra D', 'Initials': 'KD', 'LastName': 'Harrington', 'Affiliation': 'Iverson Health Innovation Research Institute, Swinburne University of Technology, Hawthorn, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Eres', 'Affiliation': 'Iverson Health Innovation Research Institute, Swinburne University of Technology, Hawthorn, Australia.'}, {'ForeName': 'Michelle H', 'Initials': 'MH', 'LastName': 'Lim', 'Affiliation': 'Iverson Health Innovation Research Institute, Swinburne University of Technology, Hawthorn, Australia.'}]",JMIR research protocols,['10.2196/21307']
2463,33274855,Naoxueshu relieves hematoma after clot removal in acute spontaneous intracerebral hemorrhage.,"OBJECTIVES
Surgical treatment is expected to remove clot immediately in acute spontaneous intracerebral hemorrhage (SICH) patients. The aim of this study was to evaluate whether Naoxueshu could enhance the efficacy of clot removal surgery in acute SICH patients.
METHODS
One hundred twenty patients who had been diagnosed as SICH according to neuroimaging were enrolled in this study. They received craniotomy, decompressive craniectomy, or minimally invasive surgical evacuation as appropriate and then were randomized into two groups: the Naoxueshu group (NXS group, n = 60) and the control group (n = 60). All the patients received standard medical management while patients in NXS group also took Naoxueshu oral liquid 10 ml with three times a day for seven consecutive days. The primary outcome was the 7-day hematoma volume and secondary outcomes were 7-day National Institutes of Health Stroke Scale (NIHSS) score and 7-day cerebral edema score.
RESULTS
After clot removal surgery, hematoma volume in NXS group (9.5 ± 8.0) was significantly decreased than that in Control group (21.3 ± 22.9, p < .0001) 7 days after surgery. Moreover, cerebral edema was also relieved after 7-day's Naoxueshu treatment (2.5 ± 0.9 vs. 2.9 ± 0.7, p = .043). Since patients in NXS group had worse baseline NIHSS score (17.2 ± 8.1 vs. 13.7 ± 10.1, p = .039), it was reasonable to conclude that Naoxueshu treatment could improve patients' neurological function because 7-day NIHSS score of the two groups was similar.
CONCLUSION
Naoxueshu oral liquid could relieve hematoma volume and cerebral edema after clot removal surgery in acute SICH patients. Moreover, it had the potential to improve patients' short-term neurological function.",2020,"After clot removal surgery, hematoma volume in NXS group (9.5 ± 8.0) was significantly decreased than that in Control group (21.3 ± 22.9, p < .0001)","['acute spontaneous intracerebral hemorrhage', 'acute SICH patients', 'One hundred twenty patients who had been diagnosed as SICH according to neuroimaging were enrolled in this study', 'acute spontaneous intracerebral hemorrhage (SICH) patients']","['craniotomy, decompressive craniectomy, or minimally invasive surgical evacuation', 'NXS', 'Naoxueshu group (NXS', 'standard medical management while patients in NXS', 'clot removal surgery']","['7-day hematoma volume and secondary outcomes were 7-day National Institutes of Health Stroke Scale (NIHSS) score and 7-day cerebral edema score', 'baseline NIHSS score', 'hematoma volume', 'cerebral edema', 'hematoma volume and cerebral edema', ""patients' short-term neurological function"", ""patients' neurological function because 7-day NIHSS score""]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",120.0,0.0581665,"After clot removal surgery, hematoma volume in NXS group (9.5 ± 8.0) was significantly decreased than that in Control group (21.3 ± 22.9, p < .0001)","[{'ForeName': 'Juexian', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Nie', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Huiqiang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'The Key Laboratory of development biology, College of Life Sciences, Jinggangshan University, Jinggangshan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.'}]",Brain and behavior,['10.1002/brb3.1957']
2464,33274816,The impact of a physician's recommendation and gender on informed decision making: A randomized controlled study in a simulated decision situation.,"OBJECTIVE
This study examined the influence of physicians' recommendations and gender on the decision-making process in a preference-sensitive situation.
METHODS
N = 201 participants were put in a hypothetical scenario in which they suffered from a rupture of the anterior cruciate ligament (ACL). They received general information on two equally successful treatment options for this injury (surgery vs physiotherapy) and answered questions regarding their treatment preference, certainty and satisfaction regarding their decision and attitude towards the treatment options. Then, participants watched a video that differed regarding physician's recommendation (surgery vs physiotherapy) and physician's gender (female vs male voice and picture). Afterwards, they indicated again their treatment preference, certainty, satisfaction and attitude, as well as the physician's professional and social competence.
RESULTS
Participants changed their treatment preferences in the direction of the physician's recommendation (P < .001). Decision certainty (P < .001) and satisfaction (P < .001) increased more strongly if the physician's recommendation was congruent with the participant's prior attitude than if the recommendation was contrary to the participant's prior attitude. Finally, participants' attitudes towards the recommended treatment became more positive (surgery recommendation: P < .001; physiotherapy recommendation: P < .001). We found no influence of the physician's gender on participants' decisions, attitudes, or competence assessments.
CONCLUSION
This research indicates that physicians should be careful with recommendations when aiming for shared decisions, as they might influence patients even if the patients have been made aware that they should take their personal preferences into account. This could be particularly problematic if the recommendation is not in line with the patient's preferences.",2020,< .001) and satisfaction (P < .001) increased more strongly if the physician's recommendation was congruent with the participant's prior attitude than if the recommendation was contrary to the participant's prior attitude.,"['N\xa0', ""participants watched a video that differed regarding physician's recommendation (surgery vs physiotherapy) and physician's gender (female vs male voice and picture"", '201 participants were put in a hypothetical scenario in which they suffered from a rupture of the anterior cruciate ligament (ACL']",[],"['satisfaction', ""participants' decisions, attitudes, or competence assessments""]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",201.0,0.0227881,< .001) and satisfaction (P < .001) increased more strongly if the physician's recommendation was congruent with the participant's prior attitude than if the recommendation was contrary to the participant's prior attitude.,"[{'ForeName': 'Anna Lea', 'Initials': 'AL', 'LastName': 'Meinhardt', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eggeling', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Cress', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Kimmerle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Bientzle', 'Affiliation': 'Knowledge Construction Lab, Leibniz-Institut fuer Wissensmedien, Tuebingen, Germany.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.13161']
2465,33274772,Effects of a self-efficacy theory-based parental education program on eczema control and parental outcomes.,"BACKGROUND
Eczema is the most common childhood skin problem worldwide. Education that enhances parental self-efficacy in carrying out appropriate eczema management is crucial to controlling eczema symptoms of their children. However, the lack of such a structured education program hinders everyday lives of eczematous children and their families. This study evaluated the effects of a self-efficacy theory-based parental eczema education program in controlling eczema of Chinese children at three months after commencement of intervention.
METHODS
An assessor-blind, 2-arm, randomized controlled trial was conducted at an outpatient clinic of a regional hospital. One hundred and thirty-six Chinese children aged 3 months to 12 years with physician-diagnosed eczema, and their parents were recruited. The intervention was underpinned by the Social Cognitive Theory. Children's disease severity, parental self-efficacy, treatment adherence, and quality of life of family members were assessed by validated tools. Generalized estimating equation model was employed to compare differential change in each outcome across time between different groups.
RESULTS
Eczema severity of children and parental self-efficacy in the intervention group were found to show greater improvement at 3-month follow-up with regression coefficient (β) -16.98 (95% CI, -21.04 to -12.92; P < .001) and β 29.39 (95% CI, 22.64-36.14; P < .001), respectively. Nearly all parents (97%) receiving the intervention rated this program as useful and helpful.
CONCLUSIONS
This program is effective in enhancing parents' self-efficacy in managing their children's eczema and improving their adherence to eczema treatment and quality of life.",2020,"RESULTS
Eczema severity of children and parental self-efficacy in the intervention group were found to show greater improvement at 3-month follow-up with regression coefficient (β) -16.98","['outpatient clinic of a regional hospital', 'Chinese children at three months after commencement of intervention', 'One hundred and thirty-six Chinese children aged 3\xa0months to 12\xa0years with physician-diagnosed eczema, and their parents were recruited']","['self-efficacy theory-based parental eczema education program', 'self-efficacy theory-based parental education program']","[""Children's disease severity, parental self-efficacy, treatment adherence, and quality of life of family members"", 'eczema control and parental outcomes', 'Eczema severity of children and parental self-efficacy']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0013595', 'cui_str': 'Eczema'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",136.0,0.0514026,"RESULTS
Eczema severity of children and parental self-efficacy in the intervention group were found to show greater improvement at 3-month follow-up with regression coefficient (β) -16.98","[{'ForeName': 'Nam Sze', 'Initials': 'NS', 'LastName': 'Cheng', 'Affiliation': 'Faculty of Medicine, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Janita Pak Chun', 'Initials': 'JPC', 'LastName': 'Chau', 'Affiliation': 'Faculty of Medicine, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Suzanne Hoi Shan', 'Initials': 'SHS', 'LastName': 'Lo', 'Affiliation': 'Faculty of Medicine, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kai Chow', 'Initials': 'KC', 'LastName': 'Choi', 'Affiliation': 'Faculty of Medicine, The Nethersole School of Nursing, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Kam Lun Ellis', 'Initials': 'KLE', 'LastName': 'Hon', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Pok Hong', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Ting Fan', 'Initials': 'TF', 'LastName': 'Leung', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13421']
2466,33274726,"An Artificial Intelligence-Based, Personalized Smartphone App to Improve Childhood Immunization Coverage and Timelines Among Children in Pakistan: Protocol for a Randomized Controlled Trial.","BACKGROUND
The immunization uptake rates in Pakistan are much lower than desired. Major reasons include lack of awareness, parental forgetfulness regarding schedules, and misinformation regarding vaccines. In light of the COVID-19 pandemic and distancing measures, routine childhood immunization (RCI) coverage has been adversely affected, as caregivers avoid tertiary care hospitals or primary health centers. Innovative and cost-effective measures must be taken to understand and deal with the issue of low immunization rates. However, only a few smartphone-based interventions have been carried out in low- and middle-income countries (LMICs) to improve RCI.
OBJECTIVE
The primary objectives of this study are to evaluate whether a personalized mobile app can improve children's on-time visits at 10 and 14 weeks of age for RCI as compared with standard care and to determine whether an artificial intelligence model can be incorporated into the app. Secondary objectives are to determine the perceptions and attitudes of caregivers regarding childhood vaccinations and to understand the factors that might influence the effect of a mobile phone-based app on vaccination improvement.
METHODS
A mixed methods randomized controlled trial was designed with intervention and control arms. The study will be conducted at the Aga Khan University Hospital vaccination center. Caregivers of newborns or infants visiting the center for their children's 6-week vaccination will be recruited. The intervention arm will have access to a smartphone app with text, voice, video, and pictorial messages regarding RCI. This app will be developed based on the findings of the pretrial qualitative component of the study, in addition to no-show study findings, which will explore caregivers' perceptions about RCI and a mobile phone-based app in improving RCI coverage.
RESULTS
Pretrial qualitative in-depth interviews were conducted in February 2020. Enrollment of study participants for the randomized controlled trial is in process. Study exit interviews will be conducted at the 14-week immunization visits, provided the caregivers visit the immunization facility at that time, or over the phone when the children are 18 weeks of age.
CONCLUSIONS
This study will generate useful insights into the feasibility, acceptability, and usability of an Android-based smartphone app for improving RCI in Pakistan and in LMICs.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04449107; https://clinicaltrials.gov/ct2/show/NCT04449107.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/22996.",2020,"This study will generate useful insights into the feasibility, acceptability, and usability of an Android-based smartphone app for improving RCI in Pakistan and in LMICs.
","['caregivers avoid tertiary care hospitals or primary health centers', 'Children in Pakistan', ""Caregivers of newborns or infants visiting the center for their children's 6-week vaccination"", 'Aga Khan University Hospital vaccination center']",['personalized mobile app'],"['Childhood Immunization Coverage and Timelines', ""children's on-time visits""]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0071561', 'cui_str': 'polyethylene glycol-glutaminase-asparaginase'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C4505149', 'cui_str': 'Immunization Coverage'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.137379,"This study will generate useful insights into the feasibility, acceptability, and usability of an Android-based smartphone app for improving RCI in Pakistan and in LMICs.
","[{'ForeName': 'Abdul Momin', 'Initials': 'AM', 'LastName': 'Kazi', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Saad Ahmed', 'Initials': 'SA', 'LastName': 'Qazi', 'Affiliation': 'Department of Electrical Engineering, NED University of Engineering and Technology, Karachi, Pakistan.'}, {'ForeName': 'Sadori', 'Initials': 'S', 'LastName': 'Khawaja', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Nazia', 'Initials': 'N', 'LastName': 'Ahsan', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Rao Moueed', 'Initials': 'RM', 'LastName': 'Ahmed', 'Affiliation': 'Department of Civil Engineering, NED University of Engineering and Technology, Karachi, Pakistan.'}, {'ForeName': 'Fareeha', 'Initials': 'F', 'LastName': 'Sameen', 'Affiliation': 'Department of Civil Engineering, NED University of Engineering and Technology, Karachi, Pakistan.'}, {'ForeName': 'Muhammad Ayub', 'Initials': 'MA', 'LastName': 'Khan Mughal', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Saqib', 'Affiliation': 'Department of Civil Engineering, NED University of Engineering and Technology, Karachi, Pakistan.'}, {'ForeName': 'Sikander', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Faculty of Electrical and Computer Engineering, NED University of Engineering and Technology, Karachi, Pakistan.'}, {'ForeName': 'Hussain', 'Initials': 'H', 'LastName': 'Kaleemuddin', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Rauf', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Raza', 'Affiliation': 'Pharmacy Services, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Jamal', 'Affiliation': 'Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Munir', 'Initials': 'M', 'LastName': 'Abbasi', 'Affiliation': 'Surrey Business School, University of Surrey, Guildford Surrey, United Kingdom.'}, {'ForeName': 'Lampros K', 'Initials': 'LK', 'LastName': 'Stergioulas', 'Affiliation': 'Surrey Business School, University of Surrey, Guildford Surrey, United Kingdom.'}]",JMIR research protocols,['10.2196/22996']
2467,33274725,Exploring Interactive Survivorship Care Plans to Support Breast Cancer Survivors: Protocol for a Randomized Controlled Trial.,"BACKGROUND
Breast cancer is the most common form of cancer among American women, accounting for 23% of all cancer survivors nationally. Yet, the availability of adequate resources and tools for supporting breast cancer survivors has not kept up with the rapid advancement in treatment options, resulting in unmet supportive care needs, particularly among low-income and minority populations. This study explores an alternative means of delivering breast cancer survivorship care plans (SCPs), with the aim of improving survivor morbidity, patient knowledge, and self-management of treatment-related symptoms, as well as addressing inconsistencies in follow-up care visits.
OBJECTIVE
The overall goal of this study is to improve the uptake of SCP recommendations via an educational intervention for breast cancer survivors, to improve treatment-related morbidity, patient knowledge, self-management, and adherence to follow-up visits. The specific aims of the study are to (1) evaluate the feasibility of the online SCP, and (2) assess the impact of the online SCP on survivorship outcomes.
METHODS
We will enroll 50 breast cancer survivors who have completed initial breast cancer treatment into a 2-armed, randomized, waitlist-controlled pilot trial, and collect data at baseline and 6 months. For the first aim, we will use mixed methods, including surveys and personal interviews among the intervention group, to determine the feasibility of providing an online, interactive SCP (called ACESO) based on the survivors' online user experience and their short-term adoption. For the secondary aim, we will compare the 2 groups to assess the primary outcomes of survivor knowledge, self-efficacy for self-management, perceived peer support, and adherence to SCP-recommended posttreatment follow-up visits to oncology and primary care; and the secondary outcomes of treatment-related morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality). We assess these outcomes by using measurements from validated instruments with robust psychometric properties.
RESULTS
We have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors. Approval for the study protocol has been obtained from the Institutional Review Board. An advisory board has also been established to provide oversight and recommendations on the conduct of the study. The study will be completed over a period of 2 years.
CONCLUSIONS
The results of this pilot study will inform the feasibility and design of a larger-scale pragmatic trial to evaluate the impact of an online breast cancer SCP on treatment-related morbidity and self-efficacy for self-management.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/23414.",2020,"We have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors.","['50 breast cancer survivors who have completed initial breast cancer treatment', 'Support Breast Cancer Survivors', 'breast cancer survivors']","['Interactive Survivorship Care Plans', 'breast cancer survivorship care plans (SCPs', 'educational intervention', 'online, interactive SCP (called ACESO']","['morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",50.0,0.0790077,"We have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors.","[{'ForeName': 'Akshat', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Consumer Health Informatics Lab, Department of Health Services and Information Management, East Carolina University, Greenville, NC, United States.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Nambisan', 'Affiliation': 'Department of Health Informatics and Administration, University of Wisconsin-Milwaukee, Milwaukee, WI, United States.'}]",JMIR research protocols,['10.2196/23414']
2468,33274689,Tirofiban combined with heparin's effect and safety in the treatment of mild to moderate acute ischemic stroke.,"Tirofiban can be used to treat patients with acute ischemic stroke (AIS), this study was to evaluate the efficacy and safety of tirofiban combined with heparin in the treatment of mild to moderate AIS. A total of 98 patients with mild to moderate AIS randomly were divided into 2 groups within 48 h: the treatment group treated with tirofiban and, and the control group treated with aspirin + clopidogrel. The treatment group was given the same scheme as the control group after the treatment of tirofiban combined with heparin for 48 h. It was found that, compared with the control group, a significant decreased National Institute of Health stroke scale (NIHSS) was found in 48 h and 14 d, especially to the Barthel index (BI) in the treatment group (P < 0.05). Furthermore, Modified Rankin Scale (MRS, ≤2) in the treatment group was significantly upregulated in 90 d (P < 0.05). However, there were no significant differences in the adverse drug reactions between the two groups. It was indicated that nerve function and long-term prognosis in patients undergoing heparin for mild to moderate AIS were obviously improved than the control group.",2020,"However, there were no significant differences in the adverse drug reactions between the two groups.","['mild to moderate AIS', 'patients undergoing', '98 patients with mild to moderate AIS', 'mild to moderate acute ischemic stroke', 'patients with acute ischemic stroke (AIS']","['aspirin + clopidogrel', 'tirofiban', 'heparin', 'tirofiban combined with heparin', 'Tirofiban']","['adverse drug reactions', 'Modified Rankin Scale (MRS, ≤2', 'Barthel index (BI', 'National Institute of Health stroke scale (NIHSS', 'nerve function and long-term prognosis']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",98.0,0.0161791,"However, there were no significant differences in the adverse drug reactions between the two groups.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Qiu', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Chongqing Medical University , Chongqing, China.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Chongqing Medical University , Chongqing, China.'}, {'ForeName': 'Linming', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Xiaoyong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': ""Department of Equipment Management, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Shengqi', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Qingping', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Mingjin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'He', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Neurology, Zigong First People's Hospital , Sichuan, China.""}]",Neurological research,['10.1080/01616412.2020.1839690']
2469,33274687,Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global Phase 3 study (FINCH 2).,"OBJECTIVES
To evaluate efficacy and safety of filgotinib in Japanese RA patients who have failed or were intolerant to one or more biologic disease-modifying antirheumatic drugs (bDMARD) from the global FINCH 2 study (NCT02873936).
METHODS
This subgroup analysis was performed using the predefined statistical analyses. The FINCH 2 study is a randomized, double-blind, placebo-controlled, Phase 3 study in adult RA patients with inadequate response to bDMARDs. The randomized patients were treated with once-daily filgotinib 200 mg, filgotinib 100 mg or placebo on a background of csDMARDs for 24 weeks.
RESULTS
Of 449 patients enrolled in the overall population, 40 patients were enrolled from Japan. In the Japanese population, the American College of Rheumatology 20% response rates at week 12 (primary endpoint) were 83.3% and 53.3% for filgotinib, 200 mg and 100 mg, respectively, vs 30.8% for placebo. Filgotinib was well tolerated, similar to the overall population.
CONCLUSIONS
Both doses of once-daily filgotinib 200 mg and filgotinib 100 mg were effective, and generally well-tolerated in Japanese patients with active refractory RA.",2020,"Filgotinib was well tolerated, similar to the overall population.
","['adult RA patients with inadequate response to bDMARDs', '40 patients were enrolled from Japan', '449 patients enrolled in the overall population', 'Japanese RA patients who have failed or were intolerant to one or more biologic disease-modifying antirheumatic drugs (bDMARD) from the global FINCH 2 study (NCT02873936', 'Japanese patients with refractory rheumatoid arthritis', 'Japanese patients with active refractory RA']","['filgotinib', 'once-daily filgotinib 200\u2009mg, filgotinib 100\u2009mg or placebo', 'placebo']",['Efficacy and safety'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0326914', 'cui_str': 'Family Fringillidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",449.0,0.478035,"Filgotinib was well tolerated, similar to the overall population.
","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Matsubara', 'Affiliation': 'Department of Orthopedics, Matsubara Mayflower Hospital, Hyogo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Amano', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Ishiguro', 'Affiliation': 'Aichi Developmental Disability Center, Aichi, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, Hiroshima University Hospital, Hiroshima, Japan.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Yamaoka', 'Affiliation': 'Department of Rheumatology and Infectious Diseases Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Genovese', 'Affiliation': 'Gilead Sciences Inc., Foster City, California, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kalunian', 'Affiliation': 'Division of Rheumatology, Allergy, and Immunology, University of California, San Diego, La Jolla, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Northumbria Healthcare,North Shields, UK.'}, {'ForeName': 'Jacques-Eric', 'Initials': 'JE', 'LastName': 'Gottenberg', 'Affiliation': 'Department of Rheumatology, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'de Vlam', 'Affiliation': 'Department of Rheumatology, Universitair Ziekenhuis Leuven, Leuven, Belgium.'}, {'ForeName': 'Beatrix', 'Initials': 'B', 'LastName': 'Bartok', 'Affiliation': 'Gilead Sciences Inc., Foster City, California, USA.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Pechonkina', 'Affiliation': 'Gilead Sciences Inc., Foster City, California, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kondo', 'Affiliation': 'Gilead Sciences K.K.,Tokyo, Japan.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Gilead Sciences Inc., Foster City, California, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences Inc., Foster City, California, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Sundy', 'Affiliation': 'Gilead Sciences Inc., Foster City, California, USA.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu.'}]",Modern rheumatology,['10.1080/14397595.2020.1859675']
2470,33274683,Oxytocin-induced facilitation of learning in a probabilistic task is associated with reduced feedback- and error-related negativity potentials.,"BACKGROUND
Feedback evaluation of actions and error response detection are critical for optimizing behavioral adaptation. Oxytocin can facilitate learning following social feedback but whether its effects vary as a function of feedback valence remains unclear.
AIMS
The present study aimed to investigate whether oxytocin would influence responses to positive and negative feedback differentially or equivalently.
METHODS
The present study employed a randomized, double-blind, placebo controlled within-subject design to investigate whether intranasal oxytocin (24 IU) influenced behavioral and evoked electrophysiological potential responses to positive or negative feedback in a probabilistic learning task.
RESULTS
Results showed that oxytocin facilitated learning and this effect was maintained in the absence of feedback. Using novel stimulus pairings, we found that oxytocin abolished bias towards learning more from negative feedback under placebo by increasing accuracy for positively reinforced stimuli. Oxytocin also decreased the feedback-related negativity difference (negative minus positive feedback) during learning, further suggesting that it rendered the evaluation of positive and negative feedback more equivalent. Additionally, post-learning oxytocin attenuated error-related negativity amplitudes but increased the late error positivity, suggesting that it may lower conflict detection between actual errors and expected correct responses at an early stage of processing but at a later stage increase error awareness and motivation for avoiding them.
CONCLUSIONS
Oxytocin facilitates learning and subsequent performance by rendering the impact of positive relative to negative feedback more equivalent and also by reducing conflict detection and increasing error awareness, which may be beneficial for behavioral adaption.",2020,"Using novel stimulus pairings, we found that oxytocin abolished bias towards learning more from negative feedback under placebo by increasing accuracy for positively reinforced stimuli.",[],"['oxytocin', 'intranasal oxytocin', 'placebo', 'Oxytocin']",[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.263793,"Using novel stimulus pairings, we found that oxytocin abolished bias towards learning more from negative feedback under placebo by increasing accuracy for positively reinforced stimuli.","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhuang', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Institute of Psychological and Cognitive Sciences, Fuzhou University, Fuzhou, China.'}, {'ForeName': 'Xinqi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Lan', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120972347']
2471,33274674,Effect of direct oral feeding following minimally invasive esophagectomy on costs and quality of life.,"AIMS
Following (minimally invasive) esophagectomy, patients often rely on tube feeding, since oral intake is often delayed. Consequently, additional support by a dietician and home care is needed until oral intake is commenced. In this study, the effects of direct start of oral feeding compared with tube feeding following an esophagectomy was evaluated on treatment costs and health-related quality of life (QoL).
METHODS
Patients undergoing a minimally invasive esophagectomy were randomized in the NUTRIENT II study between controls (nil-per-mouth during 5 days and subsequent tube feeding) and a group in whom oral feeding was started directly postoperatively. Total hospital costs (including readmission and outpatient costs) and home care data for a period of 6 months after surgery were analyzed. QoL (measured using EORTC-QLQ-C30 and EORTC OG-25) was assessed preoperatively and 6 weeks, 12 weeks, and 6 months postoperatively.
RESULTS
A total 132 patients were included (n = 65 direct oral feeding group and n = 67 control group). Mean patient hospital costs were €26,014 in the intervention group over a 6-month period compared to €26,989 in the control group (p = 0.825). Furthermore, people with direct oral feeding required significantly less home care assistance; i.e. 23 (48.9%) intervention patients versus 37 (77.1%) control patients (p = 0.004). Also, QoL in patients with direct oral feeding progressed more quickly when compared to the control group.
LIMITATIONS
Hospital costs were derived from a single hospital unit whereas costs from all the participating units may be a better reflection of the cost deviation. Availability of homecare data was limited, leading to difficulty in detecting differences in costs.
CONCLUSION
This study suggests that direct oral feeding leads to similar total costs and a significantly reduced need for home care assistance. Furthermore, QoL in intervention group increased more quickly when compared to the control group.",2020,"Furthermore, QoL in intervention group increased more quickly when compared to the control group.","['Patients undergoing a minimally invasive esophagectomy', 'A total 132 patients were included (n\u2009=\u200965 direct oral feeding group and n\u2009=\u200967 control group']",['AIMS\n\n\nFollowing (minimally invasive) esophagectomy'],"['QoL (measured using EORTC-QLQ-C30 and EORTC OG-25', 'treatment costs and health-related quality of life (QoL', 'costs and quality of life', 'Total hospital costs (including readmission and outpatient costs) and home care data', 'Mean patient hospital costs', 'home care assistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206174', 'cui_str': 'Cost, Hospital'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",132.0,0.0319081,"Furthermore, QoL in intervention group increased more quickly when compared to the control group.","[{'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Pattamatta', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}, {'ForeName': 'Laura F C', 'Initials': 'LFC', 'LastName': 'Fransen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}, {'ForeName': 'Annemarie C P', 'Initials': 'ACP', 'LastName': 'Dolmans-Zwartjes', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}, {'ForeName': 'Grard A P', 'Initials': 'GAP', 'LastName': 'Nieuwenhuijzen', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}, {'ForeName': 'Silvia M A A', 'Initials': 'SMAA', 'LastName': 'Evers', 'Affiliation': 'Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Ewout A', 'Initials': 'EA', 'LastName': 'Kouwenhoven', 'Affiliation': 'Department of Surgery, ZGT Hospital Group Twente, Almelo, the Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'van Det', 'Affiliation': 'Department of Surgery, ZGT Hospital Group Twente, Almelo, the Netherlands.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Hiligsmann', 'Affiliation': 'Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Misha D P', 'Initials': 'MDP', 'LastName': 'Luyer', 'Affiliation': 'Department of Surgery, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, the Netherlands.'}]",Journal of medical economics,['10.1080/13696998.2020.1859843']
2472,33274667,Personalized B cell response to the Lactobacillus rhamnosus GG probiotic in healthy human subjects: a randomized trial.,"The specific effects of administering live probiotics in the human gut are not well characterized. To this end, we investigated the immediate effect of Lactobacillus rhamnosus GG (LGG) in the jejunum of 27 healthy volunteers 2 h after ingestion using a combination of global RNA sequencing of human biopsies and bacterial DNA sequencing in a multi-visit, randomized, cross-over design (ClinicalTrials.gov number NCT03140878). While LGG was detectable in jejunum after 2 h in treated subjects, the gene expression response vs. placebo was subtle if assessed across all subjects. However, clustering analysis revealed that one-third of subjects exhibited a strong and consistent LGG response involving hundreds of genes, where genes related to B cell activation were upregulated, consistent with prior results in mice. Immunohistochemistry and single cell-based deconvolution analyses showed that this B cell signature likely is due to activation and proliferation of existing B cells rather than B cell immigration to the tissue. Our results indicate that the LGG strain has an immediate effect in the human gut in a subpopulation of individuals. In extension, our data strongly suggest that studies on in vivo probiotic effects in humans require large cohorts and must take individual variation into account.",2020,"While LGG was detectable in jejunum after 2 h in treated subjects, the gene expression response vs. placebo was subtle if assessed across all subjects.","['27 healthy volunteers 2\xa0h after ingestion using a combination of global RNA sequencing of human biopsies and bacterial DNA sequencing in a multi-visit', 'healthy human subjects']","['Lactobacillus rhamnosus GG probiotic', 'Lactobacillus rhamnosus GG (LGG', 'placebo', 'live probiotics']",[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0012924', 'cui_str': 'Bacterial DNA'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",[],27.0,0.0897629,"While LGG was detectable in jejunum after 2 h in treated subjects, the gene expression response vs. placebo was subtle if assessed across all subjects.","[{'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Bornholdt', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Broholm', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Rago', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Sloth', 'Affiliation': 'Gastro Unit, Herlev Hospital, University of Copenhagen , Herlev, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Hendel', 'Affiliation': 'Gastro Unit, Herlev Hospital, University of Copenhagen , Herlev, Denmark.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Melsæther', 'Affiliation': 'Human Health Discovery , Hørsholm, Denmark.'}, {'ForeName': 'Christina V', 'Initials': 'CV', 'LastName': 'Müller', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Juul Nielsen', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Strickertsson', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Engelholm', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Vitting-Seerup', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Kim B', 'Initials': 'KB', 'LastName': 'Jensen', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Human Health Discovery , Hørsholm, Denmark.'}, {'ForeName': 'Albin', 'Initials': 'A', 'LastName': 'Sandelin', 'Affiliation': 'Biotech Research and Innovation Centre, University of Copenhagen , Copenhagen N, Denmark.'}]",Gut microbes,['10.1080/19490976.2020.1854639']
2473,33274663,Effects of lorazepam on prosaccades and saccadic adaptation.,"BACKGROUND
Benzodiazepines have reliable adverse effects on saccadic eye movements, but the impact of sex as a potential modulator of these effects is less clear. A recent study reported stronger adverse effects on the spatial consistency of saccades in females, which may reflect sex differences in cerebellar mechanisms.
AIMS
We aimed to further examine the role of sex as a potential modulator of benzodiazepine effects by employing the saccadic adaptation paradigm, which is known to be sensitive to cerebellar functioning.
METHODS
A total of n =50 healthy adults performed a horizontal step prosaccade task and a saccadic adaptation task under 0.5 mg lorazepam, 1 mg lorazepam and placebo in a double-blind, within-subjects design.
RESULTS
In the prosaccade task, lorazepam had adverse effects on measures of peak velocity, latency and spatial consistency. The administration of 0.5 mg lorazepam led to significant reductions in gain-decrease adaptation, while a dose of 1 mg did not impair adaptation learning. Gain-increase adaptation was generally less pronounced, and unaffected by the drug. There were no significant drug×sex interactions in either task.
CONCLUSIONS
We conclude that a low dose of lorazepam impairs gain-decrease adaptation independent of sex. At higher doses, however, increasing fatigue may facilitate adaptation and thus counteract the adverse effects observed at lower doses. With regards to prosaccades, our findings confirm peak velocity as well as latency and spatial measures as sensitive biomarkers of GABAergic effects.",2020,"In the prosaccade task, lorazepam had adverse effects on measures of peak velocity, latency and spatial consistency.",['A total of n =50 healthy adults'],"['benzodiazepine', 'lorazepam', 'Benzodiazepines', 'horizontal step prosaccade task and a saccadic adaptation task under 0.5\u2009mg lorazepam, 1\u2009mg lorazepam and placebo']","['prosaccades and saccadic adaptation', 'Gain-increase adaptation', 'drug×sex interactions', 'peak velocity, latency and spatial consistency']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",50.0,0.191563,"In the prosaccade task, lorazepam had adverse effects on measures of peak velocity, latency and spatial consistency.","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Bey', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Julia V', 'Initials': 'JV', 'LastName': 'Lippold', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Behrem', 'Initials': 'B', 'LastName': 'Aslan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry, University of Oldenburg, Bad Zwischenahn, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881120972424']
2474,33274607,The Effect of a PEEK Material-Based External Fixator in the Treatment of Distal Radius Fractures with Non-Transarticular External Fixation.,"OBJECTIVE
To explore the effect of a PEEK material-based external fixator in the treatment of distal radius fractures with non-transarticular external fixation.
METHODS
There were 48 patients in this prospective comparative study. They were divided into two groups according to the materials used: the PEEK group and the titanium group. Wrist dorsiflexion, palmar flexion, pronation, supination, radial deviation, ulnar deviation, grip strength of the palm on the affected side, kneading force, Visual Analogue Scale/Score (VAS), Disabilities of the Arm, Shoulder, and Hand (DASH) score, operation time, frequency of fluoroscopy procedures, and X-ray results were compared between the two groups. Functional recovery was evaluated at the last follow-up according to the wrist joint evaluation criteria.
RESULTS
The baseline data were comparable between the two groups, and no significant differences were found in age, sex, fracture types (P > 0.05). There was no significant difference between the two groups in the results of DASH, grip strength, and recovery of pinch force and wrist function (dorsiflexion, clavicle, ulnar deviation, deviation, pronation, and supination) (P > 0.05). Normal limb function was achieved in the two groups of patients at an average of 6 weeks after surgery, and there was no significant difference in X-ray examination radial height (10.60 ± 1.59 vs 11.00 ± 1.53, P = 0.687), radial inclination (1.11 ± 0.24 vs 1.12 ± 0.24, P = 0.798), volar tilt (10.33 ± 2.13 vs 10.00 ± 2.08, P = 0.660), ulnar variance (20.87 ± 3.00 vs 20.38 ± 3.04, P = 0.748), and step-off persistence (1.73 ± 0.69 vs 1.68 ± 0.72, P = 0.425) between the two groups (P > 0.05). However, the operation time (54.80 ± 12.20 vs 85.23 ± 15.14, P = 0.033) and number of fluoroscopy procedures (36.93 ± 6.89 vs 64.77 ± 9.74, P = 0.000) in the PEEK group were significantly reduced compared with those in the titanium group.
CONCLUSION
Compared with the traditional titanium external fixator, the PEEK composite external fixator has advantages, such as a shorter operation time and fewer fluoroscopy procedures when used to treat different types of distal radius fracture.",2020,"There was no significant difference between the two groups in the results of DASH, grip strength, and recovery of pinch force and wrist function (dorsiflexion, clavicle, ulnar deviation, deviation, pronation, and supination) (P > 0.05).","['distal radius fractures with non-transarticular external fixation', 'Distal Radius Fractures with Non-Transarticular External Fixation']","['PEEK Material-Based External Fixator', 'PEEK material-based external fixator']","['radial inclination', 'Wrist dorsiflexion, palmar flexion, pronation, supination, radial deviation, ulnar deviation, grip strength of the palm on the affected side, kneading force, Visual Analogue Scale/Score (VAS), Disabilities of the Arm, Shoulder, and Hand (DASH) score, operation time, frequency of fluoroscopy procedures, and X-ray results', 'ulnar variance', 'number of fluoroscopy procedures', 'Functional recovery', 'X-ray examination radial height', 'Normal limb function', 'operation time', 'DASH, grip strength, and recovery of pinch force and wrist function (dorsiflexion, clavicle, ulnar deviation, deviation, pronation, and supination', 'volar tilt']","[{'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0407333', 'cui_str': 'External skeletal fixation procedure'}]","[{'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079321', 'cui_str': 'External fixation device'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C1184147', 'cui_str': 'Palmar'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0033421', 'cui_str': 'Pronation'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0449751', 'cui_str': 'Radial deviation'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0230373', 'cui_str': 'Palm of hand (surface region)'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0443349', 'cui_str': 'Volar'}]",48.0,0.016593,"There was no significant difference between the two groups in the results of DASH, grip strength, and recovery of pinch force and wrist function (dorsiflexion, clavicle, ulnar deviation, deviation, pronation, and supination) (P > 0.05).","[{'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Orthopaedic, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yinghao', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xianyi', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Orthopaedic, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Zengwu', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Department of Orthopaedic, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Nie', 'Affiliation': ""Department of Orthopaedic Surgery, Zhijiang People's Hospital, Zhijiang, China.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Xiong', 'Affiliation': 'Department of Orthopaedic, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",Orthopaedic surgery,['10.1111/os.12837']
2475,33274601,Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function.,"AIMS
Increasing attention is being given to patients with heart failure and 'mid-range' left ventricular ejection fraction (LVEF, ≥40% and <50%) for whom there are no approved therapies that improve prognosis. We aim to assess for the first time the effects of cardiac contractility modulation (CCM) therapy in this patient population.
METHODS AND RESULTS
We assessed the effects of 6- month CCM therapy on functional status, exercise tolerance and quality of life in a subgroup of 53 patients with a LVEF of 40-45% recruited in previous CCM studies, including 37 patients in the CCM group and 16 in the control group. New York Heart Association classification improved by ≥1 class from baseline to 24 weeks in 80.6% (95% confidence interval [62.5%, 92.5%]) of patients in the CCM group compared with 57.1% in the control group (95% confidence interval [28.9%, 82.3%], P = 0.15). Six-minute walk distance increased significantly in the CCM group with a net between-group treatment effect of 53.9 ± 74.2 m (P = 0.05). Peak VO 2 improved in the CCM group with a net between-group treatment effect of 2.0 ± 2.8 mL/kg/min (P = 0.02). Minnesota Living with Heart Failure Questionnaire score decreased from baseline to 24 weeks with a net between-group treatment effect of -13.1 ± 21.0 (P = 0.10). There were no significant differences in the adverse event rate between the CCM and control groups.
CONCLUSIONS
These preliminary results suggest that CCM exerts favourable effects on exercise tolerance and quality of life in patients with LVEF in the range of 40-45% with an acceptable safety profile. Further randomized controlled studies are planned to prove these effects.",2020,Six-minute walk distance increased significantly in the CCM group with a net between-group treatment effect of 53.9 ± 74.2 m (P = 0.05).,"['53 patients with a LVEF of 40-45% recruited in previous CCM studies, including 37 patients in the CCM group and 16 in the control group', 'heart failure with mildly reduced systolic function', 'patient population', ""patients with heart failure and 'mid-range' left ventricular ejection fraction (LVEF, ≥40% and <50""]","['CCM', '6- \xa0month CCM therapy', 'cardiac contractility modulation (CCM) therapy']","['Six-minute walk distance', 'Minnesota Living with Heart Failure Questionnaire score', 'functional status, exercise tolerance and quality of life', 'Peak VO 2', 'adverse event rate', 'exercise tolerance and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}]","[{'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",53.0,0.119988,Six-minute walk distance increased significantly in the CCM group with a net between-group treatment effect of 53.9 ± 74.2 m (P = 0.05).,"[{'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Tschöpe', 'Affiliation': 'Department of Cardiology, Charité-Berlin University of Medicine, Campus Rudolf Virchow, Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Farmakis', 'Affiliation': 'University of Cyprus Medical School, Nicosia, Cyprus.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Morley', 'Affiliation': 'Impulse Dynamics, Orangeburg, NY, USA.'}, {'ForeName': 'Ishu', 'Initials': 'I', 'LastName': 'Rao', 'Affiliation': 'Impulse Dynamics, Orangeburg, NY, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'Heart Failure Unit, Department of Cardiology, Attikon University Hospital, National and Kapodistrian University of Athens Medical School, 1 Rimini St., Athens, Greece.'}]",ESC heart failure,['10.1002/ehf2.13126']
2476,33274588,An international pragmatic randomised controlled trial to compare a single use negative pressure dressing versus a surgeon's preference of dressing to reduce the incidence of surgical site infection following emergency laparotomy: the SUNRRISE Trial Protocol.,"BACKGROUND
Surgical site infection (SSI) is a common complication following emergency laparotomy occurring in around 25% of patients in UK practice. The use of single use negative pressure dressings (SUNPDs) for these wounds has been proposed as a prophylactic method of reducing the rate of SSI.
METHOD
The Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy (SUNRRISE) study is an international, multicentre, pragmatic, phase III randomised controlled trial (RCT) with internal feasibility phase. The primary aim is to determine if a single use negative pressure dressing (SUNPD) reduces surgical site infection (SSI) at 30 days post-operatively. Patients will be randomised in a 1:1 ratio to either a SUNPD or to receive a dressing of the surgeon's preference. Outcome assessors will be blinded to treatment allocation. The primary outcome measure is SSI within 30 days of surgery as defined by the Centers for Disease Control criteria. A total of 840 patients will be required to detect a relative reduction of 40% in SSI rates (from 25% to 15%) with 90% power accounting for 20% attrition rate.
DISCUSSION
SUNRRISE is an international, multicentre RCT evaluating the prophylactic use of SUNPD in primary closed emergency laparotomy wounds for the reduction of SSI. Our hypothesis is that a SUNPD is superior to the surgeon's preference of dressing in reducing surgical site infections at 30 days. These findings may influence dressing choice following emergency abdominal surgery in the future.",2020,"A total of 840 patients will be required to detect a relative reduction of 40% in SSI rates (from 25% to 15%) with 90% power accounting for 20% attrition rate.
","['emergency laparotomy', '840 patients']","['negative pressure dressing', 'single use negative pressure dressings (SUNPDs', 'SUNPD', 'negative pressure dressing (SUNPD', 'Negative pRessure dressing for Reduction']","['SSI within 30 days of surgery as defined by the Centers for Disease Control criteria', 'SSI rates']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1956079', 'cui_str': 'Negative-Pressure Dressings'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",840.0,0.154227,"A total of 840 patients will be required to detect a relative reduction of 40% in SSI rates (from 25% to 15%) with 90% power accounting for 20% attrition rate.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.15474']
2477,33274557,Antinociceptive Effect of Vapocoolant Medium Stream Spray onHotplate LatencyinRat Pups.,"BACKGROUND
Heel sticks account formostblood tests performed in neonateswithout analgesia because topical localanestheticsare ineffective on heelglabrous skin. We investigated the antinociceptive effect of an alternative topical analgesic, avapocoolant spray, on hindpaws glabrous skin of rat pups. The spray was applied by two methods: method-1 for 4 seconds at a distance of 8 cm and method-2 for 10 seconds at a distance of 18 cm.
METHODS
The rat pups were randomized to either method-1 (n = 32) or method-2 (n = 31). Vapocoolant spray was applied to one hind paw randomly and saline spray was applied to the contralateral paw. The paws were exposed to a hotplate test to measure withdrawal latency timebefore and 30 seconds after the spray applications. Additionally, rat pups were tested for tissue toxicity in method-1 (n = 20) and method-2 (n = 20)after application of the vapocoolant spray before heel sticksthree times a day for two consecutive days. Analyses of spray andmethod effects on hotplate withdrawal latency time weredetermined by nonparametric Wilcoxon tests to assess paired difference between vapocoolant spray and saline spray and to compare difference in medians between the two methods.
RESULTS
METHOD: 1 and method-2vapocoolant spray applications significantly prolonged the withdrawal latency time compared to saline, a median difference of0.6 seconds (IQR 0.1-1.2)for method-1 and 9.5 seconds (IQR 5.5-10.7)for method-2 (a 15-fold longer latency time with method-2). Method-2 produced significantly longer withdrawal latency time than method-1 with a difference in median time of 8.9 seconds (CI:95% 7.3-10.4 seconds, P< 0.0001). No histopathological changes were detected.
CONCLUSIONS
Compared to method-1, the vapocoolant spray in method-2 produced significantly longer withdrawal latency time that is clinically applicable to collecting blood samples after a heel stick.",2020,"Method-2 produced significantly longer withdrawal latency time than method-1 with a difference in median time of 8.9 seconds (CI:95% 7.3-10.4 seconds, P< 0.0001).","['rat pups', 'hindpaws glabrous skin of rat pups']",['Vapocoolant spray'],"['tissue toxicity', 'withdrawal latency time', 'hotplate withdrawal latency time']","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]","[{'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0303425,"Method-2 produced significantly longer withdrawal latency time than method-1 with a difference in median time of 8.9 seconds (CI:95% 7.3-10.4 seconds, P< 0.0001).","[{'ForeName': 'Navil F', 'Initials': 'NF', 'LastName': 'Sethna', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Brenden', 'Initials': 'B', 'LastName': 'Fish', 'Affiliation': 'Contract Research Organization Operations, Biomere-BioMedical Research Models, Worcester, Massachusetts, USA.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Yahalom', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': ""Department of Pathology, Harvard Medical School, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zurakowski', 'Affiliation': ""Department of Anesthesiology, Critical Care, and Pain Medicine, Harvard Medical School, Boston Children's Hospital, Boston, Massachusetts, USA.""}]",Paediatric anaesthesia,['10.1111/pan.14096']
2478,33059317,How to introduce a rotigotine patch to Parkinson's disease patients taking oral dopamine agonists.,"OBJECTIVE
Ways of introducing a rotigotine patch to Parkinson disease (PD) patients include initial induction for dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT), and add-on (AO) for patients already taking oral DAs. We investigated whether or not the introductions method affects the continuation rate of rotigotine patch.
METHODS
The subjects were 188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital. The rate of successful continuation of rotigotine patch for one year after initiation and the reasons for discontinuation were investigated; for the patients who discontinued due to poor efficacy, the DA dose before and after the start of rotigotine patch treatment was determined.
RESULTS
The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group. The most common reason for discontinuation in all groups was skin reactions. Compared with the de novo group, only the OS group had a significantly higher discontinuation rate due to poor efficacy (3.8 % vs. 21.2 %, P < 0.001). However, in the OS group, the continuation rate in the subjects with an increased total DA dose, after rotigotine was introduced, was significantly higher than that in the subjects with a decreased total DA dose (p = 0.031).
CONCLUSION
The use of a rotigotine patch with an equivalent dose should be considered when switching from oral DAs, and appropriate care should be administered for any skin reactions. The present findings suggested that not the introduction method but the use of an equivalent dose between DA formulations might affect the continuation rate of rotigotine patch.",2020,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","['patients already taking oral DAs', '188 PD patients who started using a rotigotine patch at the Department of Neurology, Fukuoka University Hospital', ""Parkinson's disease patients taking oral dopamine agonists""]","['dopamine agonist (DA)-free patients and overnight switch (OS), cross-titration (CT', 'rotigotine patch']","['continuation rate of rotigotine patch', 'rate of successful continuation of rotigotine patch', 'continuation rate', 'discontinuation rate', '1-year continuation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0051767', 'cui_str': 'amsonic acid'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}]","[{'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1700683', 'cui_str': 'Rotigotine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0439234', 'cui_str': 'year'}]",188.0,0.0281234,"The 1-year continuation rates were 38.5 % (20/52) in the OS group, 61.5 % (8/13) in the CT group, 35.3 % (6/17) in the AO group, and 50.9 % (54/106) in the de novo group.","[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yasutaka', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Fujioka', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan. Electronic address: shinsuke@cis.fukuoka-u.ac.jp.'}, {'ForeName': 'Takayasu', 'Initials': 'T', 'LastName': 'Mishima', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hirotomo', 'Initials': 'H', 'LastName': 'Shibaguchi', 'Affiliation': 'Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Tsuboi', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Fukuoka University, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Kamimura', 'Affiliation': 'Department of Pharmaceutical and Health Care Management, Faculty of Pharmaceutical Science, Fukuoka University, Japan; Department of Hospital Pharmacy, Fukuoka University Hospital, Japan.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106266']
2479,33065448,"Effectiveness of a home-based early cognitive-motor intervention provided in daycare, home care, and foster care settings: Changes in motor development and context affordances.","BACKGROUND
Appropriate opportunities within the context are crucial to affect the motor trajectory positively.
OBJECTIVE
To investigate the effectiveness of professional-parental/caregivers' early motor-cognitive intervention on infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC). Secondary objectives were to examine if parents and caregivers modified the context to meet the infants' needs and if making modifications was positively associated with infants' development.
METHODS
Participants were 176 infants (DC = 48; HC = 58, FC = 70). Infants' were randomly assigned to intervention (IG) or comparison (CG) groups within each context. The Alberta Infant Motor Scale and Affordances in the Daycare and Home Environment for Motor Development were used. A cognitive-motor intervention was provided for infants in the intervention groups; and, a home-based support protocol for all caregivers and parents.
RESULTS
IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028). Maternal daily care and home opportunities improved for all infants.
CONCLUSIONS
Parents/caregivers' protocol combined with the cognitive-motor intervention lead to better motor outcomes and changes in the context for the IGs. Only the parent/caregivers' protocol was not strong to improve CGs motor outcomes, although changes in context were found. Intensive intervention is need for infants living in vulnerability.",2020,"RESULTS
IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","['Infants', 'infants living in vulnerability', 'Participants were 176 infants (DC\xa0=\xa048; HC\xa0=\xa058, FC\xa0=\xa070']","['cognitive-motor intervention', 'intervention (IG) or comparison (CG', ""professional-parental/caregivers' early motor-cognitive intervention"", 'home-based early cognitive-motor intervention', 'Intensive intervention']","['Maternal daily care and home opportunities', ""infants' motor development in Daycare (DC), Home Care (HC), and Foster Care (FC"", 'CGs motor outcomes', 'motor scores']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",176.0,0.0591172,"RESULTS
IGs showed higher motor scores at post-test than CGs (p values from 0.018 to 0.026) and positive changes were observed from the pre-to-post intervention for all IGs (p ≤ .0001), and for two CGs (DC p ≤ .0001; HC p = .028).","[{'ForeName': 'Nadia Cristina', 'Initials': 'NC', 'LastName': 'Valentini', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: nadiacv@esef.ufrgs.br.'}, {'ForeName': 'Carla Skilhan', 'Initials': 'CS', 'LastName': 'de Almeida', 'Affiliation': 'Universidade Federal do Rio Grande do Sul, UFRGS, Department of Physical Education, Physiotherapy and Dance, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Smith', 'Affiliation': 'University of Southern California, Division of Biokinesiology and Physical Therapy, Los Angeles, CA, USA.'}]",Early human development,['10.1016/j.earlhumdev.2020.105223']
2480,33263044,"No gender-related bias in COPD diagnosis and treatment in Sweden: a randomised, controlled, case-based trial.","Introduction
COPD is a major cause of morbidity and mortality. The prevalence, morbidity and mortality of COPD among females have increased. Previous studies indicate a possible gender bias in the diagnosis and management of COPD. The present study aims to determine if there is gender bias in the management of COPD in Sweden.
Methods
This was a double-blind, randomised (1:1), controlled, parallel-group, web-based trial using the hypothetical case scenario of a former smoker (40 pack-years and quit smoking 3 years ago) who was male or female. The participants were blind to the randomisation and the purpose of the trial. The case progressively revealed more information with associated questions on how the physician would manage the patient. Study participants chose from a list of tests and treatments at each step of the case scenario.
Results
In total, 134 physicians were randomised to a male (n=62) or a female (n=72) case. There was no difference in initial diagnosis (61 (98%) male cases and 70 (97%) female cases diagnosed with COPD) and planned diagnostic procedures between the male and female cases. Spirometry was chosen by all the physicians as one of the requested diagnostic tests. The management of the hypothetical COPD case did not differ by sex of the responding physician.
Conclusion
In Sweden, diagnosis and management of a hypothetical patient with COPD did not differ by the gender of the patient or physician.",2020,"In Sweden, diagnosis and management of a hypothetical patient with COPD did not differ by the gender of the patient or physician.","['134 physicians were randomised to a male (n=62) or a female (n=72) case', 'hypothetical case scenario of a former smoker (40 pack-years and quit smoking 3\u2005years ago) who was male or female']",[],"['initial diagnosis', 'prevalence, morbidity and mortality of COPD']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003023', 'cui_str': 'Angola'}]",[],"[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]",134.0,0.175064,"In Sweden, diagnosis and management of a hypothetical patient with COPD did not differ by the gender of the patient or physician.","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Akbarshahi', 'Affiliation': 'Dept of Clinical Sciences, Division of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Ahmadi', 'Affiliation': 'Dept of Clinical Sciences, Division of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Sandberg', 'Affiliation': 'Dept of Clinical Sciences, Division of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}, {'ForeName': 'Zac', 'Initials': 'Z', 'LastName': 'Vandersman', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Shanon-Honson', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'Dept of Clinical Sciences, Division of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.'}]",ERJ open research,['10.1183/23120541.00342-2020']
2481,33263037,"Design and rationale of two phase 3 randomised controlled trials (COUGH-1 and COUGH-2) of gefapixant, a P2X3 receptor antagonist, in refractory or unexplained chronic cough.","Background
We present study designs, dose selection and preliminary patient characteristics from two phase 3 clinical trials of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough (RCC) or unexplained chronic cough (UCC).
Methods
COUGH-1 (NCT03449134) and COUGH-2 (NCT03449147) are randomised, placebo-controlled, double-blind, parallel-group trials in subjects with RCC or UCC (age ≥18 years; cough duration ≥1 year; Cough Severity Visual Analogue Scale score ≥40 mm). The primary efficacy study periods are 12 weeks (40-week extension; COUGH-1) and 24 weeks (28-week extension; COUGH-2). Interventions include placebo, gefapixant 15 mg and gefapixant 45 mg (1:1:1 ratio). The primary efficacy endpoints are average 24-h cough frequency at Week 12 (COUGH-1) and Week 24 (COUGH-2). Awake cough frequency, patient-reported outcomes and responder analyses are secondary endpoints.
Results
The doses of 45 mg (to provide maximal efficacy and acceptable tolerability) and 15 mg (to provide acceptable efficacy and improved tolerability) were selected based on phase 1 and 2 studies. In COUGH-1, 730 participants have been randomised and treated; 74% are female with mean age of 59 years (39% over 65 years), and mean baseline duration of cough of 11.5 years. In COUGH-2, 1314 participants have been randomised and treated; 75% are female with mean age of 58 years (33% over 65 years), and mean baseline duration of cough of 11.1 years.
Conclusions
These global studies include participants with baseline characteristics consistent with previous RCC and UCC studies and will inform the efficacy and safety profile of gefapixant in the treatment of patients with RCC and UCC.",2020,"In COUGH-1, 730 participants have been randomised and treated; 74% are female with mean age of 59 years (39% over 65 years), and mean baseline duration of cough of 11.5 years.","['patients with RCC and UCC', '730 participants have been randomised and treated; 74% are female with mean age of 59 years (39% over 65 years), and mean baseline duration of cough of 11.5 years', 'subjects with RCC or UCC (age ≥18 years; cough duration ≥1 year; Cough Severity Visual Analogue Scale score ≥40\u2005mm', '1314 participants have been randomised and treated; 75% are female with mean age of 58 years (33% over 65 years), and mean baseline duration of cough of 11.1 years', 'refractory chronic cough (RCC) or unexplained chronic cough (UCC']","['placebo, gefapixant 15\u2005mg and gefapixant 45\u2005mg (1:1:1 ratio', 'placebo', 'gefapixant, a P2X3 receptor antagonist']","['tolerability', 'average 24-h cough frequency at Week 12 (COUGH-1) and Week 24 (COUGH-2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0382265', 'cui_str': 'P2X3 Purinoceptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439230', 'cui_str': 'week'}]",1314.0,0.144497,"In COUGH-1, 730 participants have been randomised and treated; 74% are female with mean age of 59 years (39% over 65 years), and mean baseline duration of cough of 11.5 years.","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Muccino', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Alyn H', 'Initials': 'AH', 'LastName': 'Morice', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, School of Basic and Medical Biosciences, King's College London, London, UK.""}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Dicpinigaitis', 'Affiliation': 'Albert Einstein College of Medicine and Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Oxford NIHR Respiratory BRC, Nuffield Dept of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Assaid', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Huub Jan', 'Initials': 'HJ', 'LastName': 'Kleijn', 'Affiliation': 'Certara Strategic Consulting, Oss, The Netherlands.'}, {'ForeName': 'Azher', 'Initials': 'A', 'LastName': 'Hussain', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Lorcan', 'Initials': 'L', 'LastName': 'McGarvey', 'Affiliation': ""Wellcome-Wolfson Institute of Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester and Manchester University NHS Trust, Manchester, UK.'}]",ERJ open research,['10.1183/23120541.00284-2020']
2482,33262876,Color stability of Bulk-Fill composite restorations.,"Background
The color stability of the composite resin is an important property that influences its clinical longevity, which remains an inherent challenge to the material. Thus, the purpose of this study was to evaluate the color stability of bulk-fill resins when exposed to dye.
Material and Methods
Cavities were prepared in 80 bovine incisors, which were randomly assigned into 4 groups (n = 20) according with the resin composite used: P60 (Control Group - Filtek P60, 3M/ESPE), FP (Filtek Bulk-Fill Posterior, 3M/ESPE), SDR (SDR, Dentsply) and FF (Filtek Bulk Fill Flow, 3M/ESPE). All restorations were performed according to the protocol of each manufacturer, the control group was restored using the incremental technique, and the other groups using single-increment technique. The color of each restoration was measured using a portable digital spectrophotometer (Easyshade-Vita) according to the CIELab system, and then the teeth were submerged in red wine for 07 days, kept in a biological oven at 37ºC. New color registration was performed to measure the ΔE index of color variation.
Results
The P60 group had the lowest average ΔE (16.96), while the FF group had the highest average (28.09) and ranged from 21.19 to 26.28 in the FP and SDR groups.
Conclusions
Analysis of the color variation showed that the control group had better color stability than the Bulk-Fill resins evaluated. Key words: Dental restoration failure, Food coloring agents, polymerization.",2020,"The P60 group had the lowest average ΔE (16.96), while the FF group had the highest average (28.09) and ranged from 21.19 to 26.28 in the FP and SDR groups.
",['80 bovine incisors'],"['resin composite used: P60 (Control Group - Filtek P60, 3M/ESPE), FP (Filtek Bulk-Fill Posterior, 3M/ESPE), SDR (SDR, Dentsply) and FF ']","['color stability', 'color stability of bulk-fill resins']","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}]","[{'cui': 'C0009570', 'cui_str': 'Composite Resins'}, {'cui': 'C1137054', 'cui_str': 'SQSTM1 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4505780', 'cui_str': 'Filtek Bulk Fill'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0112984', 'cui_str': 'Dentsply'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}]",80.0,0.0237855,"The P60 group had the lowest average ΔE (16.96), while the FF group had the highest average (28.09) and ranged from 21.19 to 26.28 in the FP and SDR groups.
","[{'ForeName': 'Marianna-Falcão', 'Initials': 'MF', 'LastName': 'Silva', 'Affiliation': 'Graduated in Dentistry from Federal University of Pernambuco.'}, {'ForeName': 'Marlon-Ferreira', 'Initials': 'MF', 'LastName': 'Dias', 'Affiliation': 'Master student of the Dentistry postgraduate program of Universidade Estadual Paulista.'}, {'ForeName': 'Paulo-Cardoso', 'Initials': 'PC', 'LastName': 'Lins-Filho', 'Affiliation': 'PhD student of the Dentistry postgraduate program of Federal University of Pernambuco.'}, {'ForeName': 'Claudio-Heliomar-Vicente', 'Initials': 'CH', 'LastName': 'Silva', 'Affiliation': 'Associate Professor at Federal University of Pernambuco.'}, {'ForeName': 'Renata-Pedrosa', 'Initials': 'RP', 'LastName': 'Guimarães', 'Affiliation': 'Associate Professor at Federal University of Pernambuco.'}]",Journal of clinical and experimental dentistry,['10.4317/jced.57579']
2483,33262730,Effects of Motor Versus Cognitive Task Prioritization During Dual-Task Practice on Dual-Task Performance in Young Adults.,"Background : Previous studies have reported positive effects of concurrent motor and cognitive task practice compared to motor or cognitive task practice only on dual-task performance in young adults. Knowledge about the effect of motor vs. cognitive task prioritization during practice on dual-task performance remains unclear and has not been investigated in depth so far. Thus, we examined the effects of motor task compared to cognitive task prioritization during dual-task practice on motor-cognitive performance in healthy young adults. Methods : Healthy young adults were randomly assigned to dual-task (DT; i.e., concurrent motor and cognitive practice) or single-task (ST; i.e., motor or cognitive task practice only) practice groups. In DT practice, subjects were instructed to either prioritize the motor or the cognitive task. The motor task required subjects to keep a stabilometer in a horizontal position. The cognitive task involved serial three subtractions. Outcome variables were the root-mean-square error (RMSE) for the motor task and the total number of correct calculations for the cognitive task. All participants practiced for 2 consecutive days under their respective treatment condition and were tested under DT condition 24 h later (i.e., retention on day 3) without providing instructions on task prioritization. Results : Irrespective of prioritization (i.e., prioritize the motor task or the cognitive task), the DT practice groups similarly improved their DT motor and cognitive task performance. The ST groups also improved motor or cognitive performance depending on their respective training contents (i.e., motor practice improved RMSE and cognitive practice improved number of correct calculations but not vice versa). Conclusion : We conclude that DT compared to ST practice is well-suited to improve DT performance, irrespective of task-prioritization. DT but not ST practice resulted in an improved modulation of both domains (i.e., motor and cognitive) during DT performance. Our findings might be explained by freeing up central resources following DT practice that can be used to effectively perform the concurrent execution of motor and cognitive processing demands. However, this process is not further enhanced by the prioritized task domain.",2020,"DT but not ST practice resulted in an improved modulation of both domains (i.e., motor and cognitive) during DT performance.","['healthy young adults', 'Young Adults', 'young adults', 'Healthy young adults']","['dual-task (DT; i.e., concurrent motor and cognitive practice) or single-task (ST; i.e., motor or cognitive task practice only) practice groups', 'Motor Versus Cognitive Task Prioritization', 'motor task compared to cognitive task prioritization during dual-task practice', ' ', 'DT']","['motor-cognitive performance', 'Dual-Task Performance', 'DT performance', 'DT motor and cognitive task performance', 'motor or cognitive performance', 'root-mean-square error (RMSE) for the motor task and the total number of correct calculations for the cognitive task']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]",,0.015245,"DT but not ST practice resulted in an improved modulation of both domains (i.e., motor and cognitive) during DT performance.","[{'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Beurskens', 'Affiliation': 'Department of Health and Social Affairs, FHM Bielefeld - University of Applied Sciences, Bielefeld, Germany.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Brueckner', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sport, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Muehlbauer', 'Affiliation': 'Division of Movement and Training Sciences/Biomechanics of Sport, University of Duisburg-Essen, Essen, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.581225']
2484,33262729,Evaluating a Board Game Designed to Promote Young Children's Delay of Gratification.,"Objective
Delay of gratification, or the extent to which one can resist the temptation of an immediate reward and wait for a larger reward later, is a self-regulatory skill that predicts positive outcomes. The aim of this research was to conduct initial tests of the effects of a board game designed to increase children's delay of gratification via two experimental studies.
Methods
Preschool children were randomized to play the study game or a control game. In Study 1, there were 48 children in the analytic sample, with a mean age of 4.81 ± 0.55 years; Study 2 included 50 children ( M = 4.02 ± 0.76 years). Delay of gratification was assessed during the study game, as well as before and after game play sessions using the Marshmallow Test.
Results
In both studies, the intervention group's likelihood of delaying gratification during the study game increased across game-play sessions ( p < 0.05). In Study 1, the intervention group also increased wait times during the Marshmallow Test versus controls ( p = 0.047). In Study 2, there was no effect on Marshmallow Test wait times.
Conclusion
Results provide some initial evidence supporting potential efficacy of a board game designed to increase delay of gratification. Future research can clarify: (1) which components of game play (if any) are linked with broader changes in delay of gratification, (2) impacts of this intervention in more diverse samples, and (3) whether experimental manipulation of delay of gratification affects outcomes like achievement and weight, which have been linked to this skill in observational studies.",2020,"In Study 1, the intervention group also increased wait times during the Marshmallow Test versus controls ( p = 0.047).","['48 children in the analytic sample, with a mean age of 4.81 ± 0.55 years; Study 2 included 50 children ( M = 4.02 ± 0.76 years', 'Methods\n\n\nPreschool children']",[],"['delay of gratification', 'Delay of gratification', 'Marshmallow Test wait times', 'wait times']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517462', 'cui_str': '0.55'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]",[],"[{'cui': 'C0870398', 'cui_str': 'Deferred Gratification'}, {'cui': 'C0330527', 'cui_str': 'Malva parviflora'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",50.0,0.0438733,"In Study 1, the intervention group also increased wait times during the Marshmallow Test versus controls ( p = 0.047).","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Anzman-Frasca', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, United States.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Curry', 'Affiliation': 'College of Arts, Media and Design, Northeastern University, Boston, MA, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Tauriello', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States.'}, {'ForeName': 'Myles S', 'Initials': 'MS', 'LastName': 'Faith', 'Affiliation': 'Center for Ingestive Behavior Research, University at Buffalo, Buffalo, NY, United States.'}, {'ForeName': 'Kaley', 'Initials': 'K', 'LastName': 'Reardon', 'Affiliation': 'Department of Pediatrics, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, United States.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Pape', 'Affiliation': 'Department of Media Study, College of Arts and Sciences, University at Buffalo, Buffalo, NY, United States.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.581025']
2485,33262048,Comparison of total hip arthroplasty with minimally invasive SuperPath approach vs. conventional posterolateral approach in elderly patients: A one-year follow-up randomized controlled research.,"OBJECTIVE
To compare difference between SuperPath approach and conventional posterolateral approach in total hip arthroplasty (THA) in elderly patients.
METHODS
The present prospective randomized controlled single blinded study enrolled a total of 96 elderly patients who received THA in our hospital during April 2015 to December 2018. All patients were randomly divided into the SuperPath group and the conventional group. General demographic characteristics and intraoperative data, as well as hospitalization time were recorded. Harris scores were used for measurement of hip function and visual analogue scale (VAS) was used for pain measurement. Serum levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and creatine phosphokinase (CK) were measured before and 24 h after surgery. Gait analysis was conducted by the method of footprints.
RESULTS
The mean surgical time was remarkably longer, the mean blood loss and incision length were significantly lower and the hospitalization time was also shorter in the SuperPath group compared with the conventional group. Both levels of CRP and CK were remarkably lower in the SuperPath group. At time points of 7 d and 1 mon after surgery, the VAS scores were significantly lower, and at 7 d, 1 mon and 3 mon the Harris scores were markedly higher in the SuperPath group compared with the conventional group. The step length and stride speed were significantly larger in the SuperPath group at 7 d and 1 mon after surgery than the conventional group. Joint dislocation was found in 2 cases of patients in the conventional group and no dislocation case was found in the SuperPath group. The angles of anteversion showed no significant difference, while the angles of abduction were significantly lower in the SuperPath group.
CONCLUSION
Patients with SuperPath approach had lower levels of CRP, ESR and CK, better hip function and less pain, as well as better gait condition than patients with conventional posterolateral approach in elderly patients.",2020,The step length and stride speed were significantly larger in the SuperPath group at 7 d and 1 mon after surgery than the conventional group.,"['96 elderly patients who received THA in our hospital during April 2015 to December 2018', 'elderly patients', 'total hip arthroplasty (THA) in elderly patients']","['total hip arthroplasty with minimally invasive SuperPath approach vs. conventional posterolateral approach', 'SuperPath approach and conventional posterolateral approach']","['Joint dislocation', 'lower levels of CRP, ESR and CK, better hip function and less pain', 'hospitalization time', 'hip function and visual analogue scale (VAS', 'mean blood loss and incision length', 'CRP and CK', 'step length and stride speed', 'VAS scores', 'angles of abduction', 'Serum levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and creatine phosphokinase (CK', 'mean surgical time']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0347984', 'cui_str': 'During'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach'}]","[{'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",96.0,0.0270692,The step length and stride speed were significantly larger in the SuperPath group at 7 d and 1 mon after surgery than the conventional group.,"[{'ForeName': 'Xiaoliu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Minhang Hospital Affiliated to Fudan University, Shanghai, 201199, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiovascular Medicine, Tianyou Hospital, Wuhan University of Science and Technology, Wuhan, 430064, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiothoracic Surgery, Zhoupu Hospital Affiliated to Shanghai Medical College of Health, Shanghai, 201318, China. Electronic address: q_wang@21cn.com.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Rong', 'Affiliation': 'Department of Orthopedics, Minhang Hospital Affiliated to Fudan University, Shanghai, 201199, China. Electronic address: nhfip6@163.com.'}]",Asian journal of surgery,['10.1016/j.asjsur.2020.11.014']
2486,33262033,"Effects of Propofol, Dexmedetomidine, or Ketofol on Respiratory and Hemodynamic Profiles in Cardiac Patients Undergoing Transesophageal Echocardiography: A Prospective Randomized Study.","OBJECTIVES
The authors aimed to evaluate sedation characteristics, as well as cardiorespiratory effects, of propofol, dexmedetomidine, and ketofol used for conscious sedation during transesophageal echocardiography (TEE).
DESIGN
Prospective double-blind randomized study.
SETTINGS
Tanta University hospitals.
PARTICIPANTS
Seventy-five participants with left-to-right shunt requiring diagnostic TEE interventions. Patients were randomized into three groups-P, Dex, and K-to receive propofol, dexmedetomidine, or ketofol, respectively.
MEASUREMENTS AND MAIN RESULTS
Time to reach targeted sedation level, duration of the procedure, recovery time, hemodynamic parameters, incidence of oxygen desaturation <90%, as well as the cardiologist's satisfaction were recorded. The time onset and offset of sedation, duration of TEE procedure, and the need for rescue propofol were significantly less in the P and K groups compared with group Dex (p value 0.000*, 0.003*, 0.000*, and 0.000* and effect size 0.39, 0.15, 0.21, and 0.34, respectively). Mean arterial pressure, heart rate, and cardiac output significantly decreased in groups P and Dex compared with either baseline or group K. Hypoxic events were more manifest in group P; whereas group K had better cardiologist's satisfaction than the other two groups.
CONCLUSIONS
In the TEE settings, the three agents were capable of attaining the targeted sedation levels , with propofol and ketofol having a faster onset and recovery times compared with dexmedetomidine. Even though dexmedetomidine and ketofol provided a more stable respiratory profile than propofol, ketofol was favorable in providing fewer hemodynamic alterations with better satisfaction scores than both propofol and dexmedetomidine.",2020,"Even though dexmedetomidine and ketofol provided a more stable respiratory profile than propofol, ketofol was favorable in providing fewer hemodynamic alterations with better satisfaction scores than both propofol and dexmedetomidine.","['Seventy-five participants with left-to-right shunt requiring diagnostic TEE interventions', 'Tanta University hospitals', 'Cardiac Patients Undergoing Transesophageal Echocardiography']","['propofol, dexmedetomidine, and ketofol used for conscious sedation during transesophageal echocardiography (TEE', 'dexmedetomidine', 'Dex, and K-to receive propofol, dexmedetomidine, or ketofol, respectively', 'Propofol, Dexmedetomidine, or Ketofol']","[""Time to reach targeted sedation level, duration of the procedure, recovery time, hemodynamic parameters, incidence of oxygen desaturation <90%, as well as the cardiologist's satisfaction"", ""cardiologist's satisfaction"", 'time onset and offset of sedation, duration of TEE procedure, and the need for rescue propofol', 'Mean arterial pressure, heart rate, and cardiac output']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0428870', 'cui_str': 'Left to right cardiovascular shunt'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0206054', 'cui_str': 'Transesophageal echocardiography'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}]",75.0,0.0318382,"Even though dexmedetomidine and ketofol provided a more stable respiratory profile than propofol, ketofol was favorable in providing fewer hemodynamic alterations with better satisfaction scores than both propofol and dexmedetomidine.","[{'ForeName': 'Mona Blough', 'Initials': 'MB', 'LastName': 'El Mourad', 'Affiliation': 'Anesthesia and Surgical Intensive Care, Tanta University, Tanta, Egypt. Electronic address: monamorad80@gmail.com.'}, {'ForeName': 'Aliaa Elsaid', 'Initials': 'AE', 'LastName': 'Shaaban', 'Affiliation': 'Cardiology, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Sara Ibrahim', 'Initials': 'SI', 'LastName': 'El Sharkawy', 'Affiliation': 'Cardiology, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed Elsayed', 'Initials': 'ME', 'LastName': 'Afandy', 'Affiliation': 'Anesthesia and Surgical Intensive Care, Tanta University, Tanta, Egypt.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.11.013']
2487,33262022,Does Blood Transfusion Have an Effect on Outcomes After Aortic Valve Replacement Surgery?,"OBJECTIVE
Long-term outcomes following surgical aortic valve replacement (AVR) are excellent. However, there is a significant early morbidity burden. Red cell transfusion is common in the perioperative period and deleterious effects of receiving a transfusion on early postoperative morbidity are well described in observational studies. This study aimed to assess the effect of transfusion on ischaemic or infective outcomes after aortic valve replacement.
METHODS
Data from 270 patients enrolled in the Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC) randomised controlled trial was used to create two cohorts, patients that received red cell transfusions following AVR and those that did not. Propensity score matching was performed to limit the effect of confounding variables. Strict transfusion thresholds were maintained, with patients receiving a transfusion if haemoglobin concentration fell below 80 g/L, or if significant bleeding or haemodynamic instability occurred. The primary outcome was a composite of ischaemic event (myocardial infarction, permanent stroke, gut ischaemia or acute kidney injury) or serious infection (sepsis, endocarditis, respiratory tract or wound infection). Patients were followed for 12 weeks following surgery.
RESULTS
Sixty-three (63) of 270 patients received a red cell transfusion (23.3%). Transfused patients had significantly lower body mass index (BMI), a higher proportion of females, a lower preoperative haemoglobin and haematocrit, a higher EuroSCORE II score, worse renal function and were more likely to have undergone urgent surgery compared to the unadjusted control cohort. Once matched, there was no difference in the primary outcome between cohorts. There was a significantly increased length of hospital stay in the transfused group (median 7 days transfused, median 5 days not-transfused, p=0.001).
CONCLUSIONS
Red cell transfusion, using a transfusion threshold of 80 g/L, does not appear to be associated with adverse ischaemic or infective outcomes after aortic valve replacement.",2020,"The primary outcome was a composite of ischaemic event (myocardial infarction, permanent stroke, gut ischaemia or acute kidney injury) or serious infection (sepsis, endocarditis, respiratory tract or wound infection).","['Data from 270 patients enrolled in the', 'Sixty-three (63) of 270 patients received a']","['surgical aortic valve replacement (AVR', 'Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC', 'transfusion', 'red cell transfusion']","['length of hospital stay', 'body mass index (BMI', 'composite of ischaemic event (myocardial infarction, permanent stroke, gut ischaemia or acute kidney injury) or serious infection (sepsis, endocarditis, respiratory tract or wound infection', 'preoperative haemoglobin and haematocrit, a higher EuroSCORE II score, worse renal function']","[{'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319614', 'cui_str': '63'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0024764', 'cui_str': 'Bone structure of manubrium'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0014118', 'cui_str': 'Endocarditis'}, {'cui': 'C0035237', 'cui_str': 'Structure of respiratory system'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3164744', 'cui_str': 'European system for cardiac operative risk evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",270.0,0.208887,"The primary outcome was a composite of ischaemic event (myocardial infarction, permanent stroke, gut ischaemia or acute kidney injury) or serious infection (sepsis, endocarditis, respiratory tract or wound infection).","[{'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Bayliss', 'Affiliation': 'Department of Cardiothoracic Surgery, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Maier', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Adetayo', 'Initials': 'A', 'LastName': 'Kasim', 'Affiliation': 'Department of Anthropology, Durham University, Durham, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hancock', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Akowuah', 'Affiliation': 'Department of Cardiothoracic Surgery, The James Cook University Hospital, Middlesbrough, UK. Electronic address: Enoch.Akowuah@nhs.net.'}]","Heart, lung & circulation",['10.1016/j.hlc.2020.10.017']
2488,33262013,Pragmatic Nonpharmacologic Interventions to Improve Patient Sleep and Decrease Delirium.,,2020,,[],['Pragmatic Nonpharmacologic Interventions'],['Patient Sleep and Decrease Delirium'],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",,0.0211856,,"[{'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Rottweiler', 'Affiliation': 'Civilian Institution Program, Air Force Institute of Technology, Wright-Patterson Air Force Base, OH.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Flynn Makic', 'Affiliation': 'College of Nursing, University of Colorado, Aurora, CO. Electronic address: marybeth.makic@cuanschutz.edu.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.07.008']
2489,33262012,"Preoperative Intravenous Versus Oral Acetaminophen in Outpatient Surgery: A Double-Blinded, Randomized Control Trial.","PURPOSE
Preoperative acetaminophen is recognized as an effective part of the multimodal approach to perioperative pain management. The present study, conducted between April 12, 2018 and February 14, 2019, examined whether there are differences in patient-reported pain, postoperative opioid consumption, negative opioid effects, length of postanesthesia care unit stay, and patient satisfaction with pain control between patients who receive intravenous (IV) acetaminophen and patients who receive oral acetaminophen.
DESIGN
This double-blinded, randomized controlled trial was conducted among 120 patients undergoing outpatient surgery.
METHODS
Patients were randomized to receive preoperatively either intravenous (IV) acetaminophen (and oral placebo) or oral acetaminophen (and IV placebo). Results were analyzed using SPSS statistical software; statistical analyses consisted of Mann-Whitney U test, independent samples t test, and χ 2 test. In all analyses, a P value less than .05 was considered significant.
FINDINGS
There were no significant differences in any outcome measures based on the route of acetaminophen administration.
CONCLUSIONS
The findings of the present study support the practice of administering oral acetaminophen, as opposed to IV acetaminophen, preoperatively as part of the multimodal approach to manage postoperative pain in patients able to tolerate preoperative oral medications.",2020,"There were no significant differences in any outcome measures based on the route of acetaminophen administration.
","['patients able to tolerate preoperative oral medications', 'Patients', '120 patients undergoing outpatient surgery', 'Outpatient Surgery']","['acetaminophen', 'intravenous (IV) acetaminophen and patients who receive oral acetaminophen', 'intravenous (IV) acetaminophen (and oral placebo) or oral acetaminophen (and IV placebo', 'Preoperative Intravenous Versus Oral Acetaminophen']","['pain, postoperative opioid consumption, negative opioid effects, length of postanesthesia care unit stay, and patient satisfaction with pain control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",120.0,0.313437,"There were no significant differences in any outcome measures based on the route of acetaminophen administration.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Pelzer', 'Affiliation': 'TriHealth Bethesda Butler Hospital, Hamilton, OH. Electronic address: diana_pelzer@trihealth.com.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Burgess', 'Affiliation': 'Seven Hills Anesthesia, Cincinnati, OH.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cox', 'Affiliation': 'TriHealth Bethesda Butler Hospital, Hamilton, OH.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': 'TriHealth Corporate Nursing, Cincinnati, OH.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2020.07.010']
2490,33262006,Assessing measures of aspirin adherence in pregnancy: Secondary analysis of the TEST randomized controlled trial.,,2020,,['pregnancy'],[],['aspirin adherence'],"[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",[],"[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.180766,,"[{'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Mone', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical & Dental Sciences, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK; UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mulcahy', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Navaratnam', 'Affiliation': ""Centre for Women's Health Research, Institute of Translational Medicine, University of Liverpool, UK.""}, {'ForeName': 'Marie M', 'Initials': 'MM', 'LastName': 'Phelan', 'Affiliation': 'Institute of Integrative Biology & Technology Directorate. NMR Centre for Structural Biology. University of Liverpool, UK.'}, {'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Breathnach', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Parnell Square, Dublin 1, Ireland.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Alfirevic', 'Affiliation': 'The Wolfson Centre for Personalised Medicine. Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, UK.'}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe Frcog', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical & Dental Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK. Electronic address: Fionnuala.mcauliffe@ucd.ie.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.11.058']
2491,33261052,Maintenance of Energy Homeostasis during Calorically Restricted Ketogenic Diet and Fasting-MR-Spectroscopic Insights from the ERGO2 Trial.,"Background: The ERGO2 (Ernaehrungsumstellung bei Patienten mit Rezidiv eines Glioblastoms) MR-spectroscopic imaging (MRSI) subtrial investigated metabolism in patients randomized to calorically restricted ketogenic diet/intermittent fasting (crKD-IF) versus standard diet (SD) in addition to re-irradiation (RT) for recurrent malignant glioma. Intracerebral concentrations of ketone bodies (KB), intracellular pH (pH i ), and adenosine triphosphate (ATP) were non-invasively determined. Methods: 50 patients were randomized (1:1): Group A keeping a crKD-IF for nine days, and Group B a SD. RT was performed on day 4-8. Twenty-three patients received an extended MRSI-protocol ( 1 H decoupled 31 P MRSI with 3D chemical shift imaging (CSI) and 2D 1 H point-resolved spectroscopy (PRESS)) at a 3T scanner at baseline and on day 6. Voxels were selected from the area of recurrent tumor and contralateral hemisphere. Spectra were analyzed with LCModel, adding simulated signals of 3-hydroxybutyrate (βOHB), acetone (Acn) and acetoacetate (AcAc) to the standard basis set. Results: Acn was the only reliably MRSI-detectable KB within tumor tissue and/or normal appearing white matter (NAWM). It was detected in 4/11 patients in Group A and in 0/8 patients in Group B. MRSI results showed no significant depletion of ATP in tumor tissue of patients at day 6 during crKD-IF, even though there were a significant difference in ketone serum levels between Group A and B at day 6 and a decline in fasting glucose in Group A from baseline to day 6. The tumor specific alkaline pH i was maintained. Conclusions: Our metabolic findings suggest that tumor cells maintain energy homeostasis even with reduced serum glucose levels and may generate additional ATP through other sources.",2020,"It was detected in 4/11 patients in Group A and in 0/8 patients in Group B. MRSI results showed no significant depletion of ATP in tumor tissue of patients at day 6 during crKD-IF, even though there were a significant difference in ketone serum levels between Group A and B at day 6 and a decline in fasting glucose in Group A from baseline to day 6.","['50 patients were randomized (1:1', 'patients randomized to calorically restricted ketogenic diet/intermittent fasting (crKD-IF) versus']","['MR-spectroscopic imaging (MRSI', 'standard diet (SD) in addition to re-irradiation (RT', 'extended MRSI-protocol ( 1 H decoupled 31 P MRSI with 3D chemical shift imaging (CSI) and 2D 1 H point-resolved spectroscopy (PRESS']","['ketone serum levels', 'fasting glucose', 'depletion of ATP in tumor tissue', 'Intracerebral concentrations of ketone bodies (KB), intracellular pH (pH i ), and adenosine triphosphate (ATP', 'serum glucose levels', '3-hydroxybutyrate (βOHB), acetone (Acn) and acetoacetate (AcAc']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0242411', 'cui_str': 'Chemical Shift Imaging'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}]","[{'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022631', 'cui_str': 'Ketone body'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}, {'cui': 'C0001002', 'cui_str': 'Acetone'}, {'cui': 'C0000988', 'cui_str': 'Acetoacetates'}]",50.0,0.0506785,"It was detected in 4/11 patients in Group A and in 0/8 patients in Group B. MRSI results showed no significant depletion of ATP in tumor tissue of patients at day 6 during crKD-IF, even though there were a significant difference in ketone serum levels between Group A and B at day 6 and a decline in fasting glucose in Group A from baseline to day 6.","[{'ForeName': 'Katharina J', 'Initials': 'KJ', 'LastName': 'Wenger', 'Affiliation': 'Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, 60528 Frankfurt am Main, Germany.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, 60528 Frankfurt am Main, Germany.'}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Harter', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Franz', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Bojunga', 'Affiliation': 'Frankfurt Cancer Institute (FCI), 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Imhoff', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Rieger', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, 60528 Frankfurt am Main, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hattingen', 'Affiliation': 'Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, 60528 Frankfurt am Main, Germany.'}, {'ForeName': 'Joachim P', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, 60590 Frankfurt am Main, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Pilatus', 'Affiliation': 'Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, 60528 Frankfurt am Main, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Voss', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, 60590 Frankfurt am Main, Germany.'}]",Cancers,['10.3390/cancers12123549']
2492,33261032,The Effect of Acute Caffeine Ingestion on Cognitive Dual Task Performance during Assessment of Static and Dynamic Balance in Older Adults.,"The present work aimed to evaluate the effect of 3 mg·kg -1 caffeine consumption on the standing and dynamic balance performance of older adults and sought to establish if caffeine ingestion can modulate the influence of a cognitive dual task on balance performance. Twelve apparently healthy participants (8 females) aged >65 years (72 ± 3.7 years) completed the study. Bipedal postural sway, four square step test, timed up and go, Y-balance (anterior reach only) and force-time characteristics of sit-to-stand performance were used to assess standing and dynamic balance. Attention and working memory were assessed using a serial 3s and 7s subtraction task during seated rest and completion of the bipedal standing assessment and Y-balance test. This battery of assessments was completed on two separate occasions, once following the consumption of a non-ergogenic placebo and again following the consumption of 3 mg·kg -1 caffeine. The administration of treatments was randomised, counterbalanced and double-blind. Caffeine reduced performance in the bipedal standing balance assessments, evidenced by an increase in COP ML , COP Path , COP Velocity . Performance during the dynamic balance tests was unaffected, other than rate of force development during the sit-to-stand, which was improved following caffeine ingestion. The introduction of a cognitive dual task had either limited effects, or improved facets of bipedal standing balance, whilst performance during the dynamic balance task was significantly reduced. In both balance assessments, there was evidence for a reduction in the performance of the cognitive task when both the balance and cognitive tests were performed simultaneously, with this effect not modulated by caffeine consumption. These findings refute the idea that caffeine ingestion may have positive effects on balance performance. However, despite a caffeine-induced reduction in bipedal standing balance, it is unlikely that caffeine ingestion would exacerbate fall risk given the limited effects in the dynamic balance tests. Future work should establish if these effects are generalisable to older frail participants and if caffeine can modulate the detrimental effects of an acute exercise bout on balance performance.",2020,"Performance during the dynamic balance tests was unaffected, other than rate of force development during the sit-to-stand, which was improved following caffeine ingestion.","['older frail participants', 'older adults', 'Older Adults', 'Twelve apparently healthy participants (8 females) aged >65 years (72 ± 3.7 years) completed the study']","['Caffeine', '3 mg·kg -1 caffeine consumption', 'ergogenic placebo', 'Acute Caffeine Ingestion']","['Bipedal postural sway, four square step test, timed up and go, Y-balance (anterior reach only) and force-time characteristics of sit-to-stand performance', 'Cognitive Dual Task Performance', 'bipedal standing balance', 'balance performance', 'COP ML , COP Path , COP Velocity ', 'Attention and working memory']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C2936450', 'cui_str': 'Ergogenic Substances'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0056471', 'cui_str': 'creatinolfosfate'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",12.0,0.0494809,"Performance during the dynamic balance tests was unaffected, other than rate of force development during the sit-to-stand, which was improved following caffeine ingestion.","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Tallis', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Bradford', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Leddington-Wright', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Higgins', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Centre for Applied Biological and Exercise Sciences, Alison Gingell Building, Coventry University, Priory Street, Coventry CV15FB, UK.'}]",Nutrients,['10.3390/nu12123653']
2493,33260939,"Effects of the Amount and Frequency of Fluid Intake on Cognitive Performance and Mood among Young Adults in Baoding, Hebei, China: A Randomized Controlled Trial.","Water is a critical nutrient that is important for the maintenance of the physiological function of the human body. This article aimed to investigate the effects of the amount and frequency of fluid intake on cognitive performance and mood. A double-blinded randomized controlled trial was designed and implemented on college students aged 18-23 years in Baoding, China. Participants were randomly assigned into one of three groups: the recommended behavior group (RB group) who drank 200 mL of water every 2 h, the half amount group (HA group) who drank 100 mL of water every 2 h, and the high frequency group (HF group) who drank 110 mL of water every 1 h. The intervention lasted 2 days. Urine osmolality, cognitive performance, and mood of participants in each group were compared using the one-way analysis of variance (ANOVA). A total of 92 participants (46 females, 46 males) completed this study with a completion rate of 95.8%. The urine osmolality of the HA group was higher than that of the RB group and the HF group at two time points ( p < 0.05). At time point 1, the scores in the portrait memory test and vigor were statistically different ( F = 20.45, p < 0.001; F = 5.46, p = 0.006). It was found that the scores for the portrait memory test in the RB group were lower than those in the HA group and the HF group ( p = 0.007; p < 0.001), while the scores of the HF group were higher than those of the HA group ( p < 0.001). The scores for vigor in the RB group were significantly higher than those of the HA group ( p = 0.006), and they were also significantly higher than those of the HF group ( p = 0.004). At time point 2, only the scores for vigor were statistically different ( F = 3.80, p = 0.026). It was found that the scores for vigor in the RB group were higher than those in the HA group and HF group ( p = 0.018; p = 0.019). Both the amount and frequency of fluid intake may affect urine osmolality and vigor, but these factors have limited impacts on cognitive performance. Rational fluid intake behavior may be beneficial to improve the hydration status and mood of young adults. More research is needed, especially experimental research, to allow causal conclusions to be drawn.",2020,It was found that the scores for vigor in the RB group were higher than those in the HA group and HF group ( p = 0.018; p = 0.019).,"['college students aged 18-23 years in Baoding, China', 'young adults', 'Young Adults in Baoding, Hebei, China', '92 participants (46 females, 46 males) completed this study with a completion rate of 95.8']","['behavior group (RB group) who drank 200 mL of water every 2 h, the half amount group (HA group) who drank 100 mL of water every 2 h, and the high frequency group (HF group) who drank 110 mL of water every 1 h', 'Fluid Intake']","['Urine osmolality, cognitive performance, and mood', 'Cognitive Performance and Mood', 'scores for vigor', 'portrait memory test', 'cognitive performance and mood', 'portrait memory test and vigor', 'urine osmolality']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}]","[{'cui': 'C0740085', 'cui_str': 'Osmolality measurement, urine'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376644', 'cui_str': 'Portraits'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",92.0,0.0643554,It was found that the scores for vigor in the RB group were higher than those in the HA group and HF group ( p = 0.018; p = 0.019).,"[{'ForeName': 'Hairong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Jianfen', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing 100053, China.'}, {'ForeName': 'Shufang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Health Science Center, Hebei University, Baoding 071000, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17238813']
2494,33260928,Women's Intentions to Engage in Risk-Reducing Behaviours after Receiving Personal Ovarian Cancer Risk Information: An Experimental Survey Study.,"Risk stratification using genetic and/or other types of information could identify women at increased ovarian cancer risk. The aim of this study was to examine women's potential reactions to ovarian cancer risk stratification. A total of 1017 women aged 45-75 years took part in an online experimental survey. Women were randomly assigned to one of three experimental conditions describing hypothetical personal results from ovarian cancer risk stratification, and asked to imagine they had received one of three results: (a) 5% lifetime risk due to single nucleotide polymorphisms (SNPs) and lifestyle factors; (b) 10% lifetime risk due to SNPs and lifestyle factors; (c) 10% lifetime risk due to a single rare mutation in a gene. Results: 83% of women indicated interest in having ovarian cancer risk assessment. After receiving their hypothetical risk estimates, 29% of women stated they would have risk-reducing surgery. Choosing risk-reducing surgery over other behavioural responses was associated with having higher surgery self-efficacy and perceived response-efficacy, but not with perceptions of disease threat, i.e., perceived risk or severity, or with experimental condition. A substantial proportion of women age 45-75 years may be open to the idea of surgery to reduce risk of ovarian cancer, even if their absolute lifetime risk is only increased to as little as 5 or 10%.",2020,"Choosing risk-reducing surgery over other behavioural responses was associated with having higher surgery self-efficacy and perceived response-efficacy, but not with perceptions of disease threat, i.e., perceived risk or severity, or with experimental condition.",['1017 women aged 45-75 years took part in an online experimental survey'],"['hypothetical personal results from ovarian cancer risk stratification, and asked to imagine they had received one of three results: (a) 5% lifetime risk due to single nucleotide polymorphisms (SNPs) and lifestyle factors; (b) 10% lifetime risk due to SNPs and lifestyle factors']",['risk-reducing surgery'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",1017.0,0.0446198,"Choosing risk-reducing surgery over other behavioural responses was associated with having higher surgery self-efficacy and perceived response-efficacy, but not with perceptions of disease threat, i.e., perceived risk or severity, or with experimental condition.","[{'ForeName': 'Ailish', 'Initials': 'A', 'LastName': 'Gallagher', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, Gower Street, London WC1E 6BT, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': ""Cancer Prevention Group, School of Cancer & Pharmaceutical Sciences, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.""}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Manchanda', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London EC1M 6BQ, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Jacobs', 'Affiliation': ""Department of Women's Health, University of New South Wales, Australia, Level 1, Chancellery Building, Sydney 2052, Australia.""}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Sanderson', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, Gower Street, London WC1E 6BT, UK.'}]",Cancers,['10.3390/cancers12123543']
2495,33274370,"Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis.","BACKGROUND
Gastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes.
OBJECTIVES
We sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered.
METHODS
This was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3-48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received.
RESULTS
A total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions > 0.05).
CONCLUSIONS
LGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE.This trial was registered at clinicaltrials.gov as NCT01773967.",2020,"There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome.","['813 children (84%) were included in the analysis; 413 received', 'children 3-48 mo of age with AGE', 'Children with Acute Gastroenteritis', '971 children, Lactobacillus rhamnosus GG (LGG']","['placebo and 400 LGG', 'placebo', 'LGG']","['adjusted weight percentile', 'vomiting episodes', 'adjusted weight z score', 'vomiting duration', 'diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects', 'moderate to severe gastroenteritis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0474496', 'cui_str': 'Diarrhea and vomiting, symptom'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0401151', 'cui_str': 'Chronic diarrhea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0017160', 'cui_str': 'Gastroenteritis'}]",813.0,0.61472,"There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnadower', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sapien', 'Affiliation': 'Department of Emergency Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'T Charles', 'Initials': 'TC', 'LastName': 'Casper', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Vance', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of California, Davis, School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phillip I', 'Initials': 'PI', 'LastName': 'Tarr', 'Affiliation': 'Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': ""O'Connell"", 'Affiliation': ""Division of Emergency Medicine, Children's National Health System, Department of Pediatrics and Emergency Medicine, The George Washington School of Medicine and Health Sciences, Washington, DC, USA.""}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Levine', 'Affiliation': ""Department of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence, RI, USA.""}, {'ForeName': 'Cindy G', 'Initials': 'CG', 'LastName': 'Roskind', 'Affiliation': 'Division of Emergency Medicine, Department of Pediatrics, Columbia University College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Seema R', 'Initials': 'SR', 'LastName': 'Bhatt', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Mahajan', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Powell', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann & Robert H Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Cody S', 'Initials': 'CS', 'LastName': 'Olsen', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Marc H', 'Initials': 'MH', 'LastName': 'Gorelick', 'Affiliation': ""Central Administration, Children's Minnesota, Minneapolis, MN, USA.""}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of nutrition,['10.1093/jn/nxaa313']
2496,33274350,Transcranial Direct Current Stimulation (tDCS) Can Alter Cortical Excitability of the Lower Extremity in Healthy Participants: A Review and Methodological Study.,"Objective
Transcranial direct current stimulation (tDCS) has been used to alter cortical excitability of the lower extremity (LE) and to influence performance on LE tasks like ankle tracking accuracy; but no study, to our knowledge, ever reported a significant change in cortical excitability relative to sham-tDCS. Additionally, because several different electrode montages were used in previous studies, it is difficult to know how stimulation should be applied to achieve this effect. Our objective was to determine whether active-tDCS alters cortical excitability of the LE and ankle tracking accuracy relative to sham-tDCS in healthy participants. The efficacy of two electrode montages and two conductance mediums were compared.
Methods
A triple-blind, fully randomized, within-subjects study was conducted with healthy participants (N=18, 24.2 (6.6) years). Cortical recruitment curves and measures of ankle tracking accuracy for the dominant lower extremity were obtained before and after participants received active-tDCS at 2 milliamps for 20 minutes using montage-medium combinations of M 1 -SO:Saline, M 1 -SO:Gel, C1-C2:Saline, and C1-C2:Gel and a sham-tDCS condition (M1-SO: Saline).
Results
The motor evoked potential maximum of the recruitment curve was significantly lower for active than sham-tDCS, but only for the M 1 -SO:Saline combination. No other significant differences in the recruitment curve parameters or in ankle tracking were found.
Conclusions
This is the first study to our knowledge to demonstrate a significant difference in cortical excitability of the LE between active and sham-tDCS conditions. Given the order in which the experimental procedures occurred, the result is consistent with the concept of a homeostatic plasticity response.",2020,"The motor evoked potential maximum of the recruitment curve was significantly lower for active than sham-tDCS, but only for the M 1 -SO:Saline combination.","['Healthy Participants', 'healthy participants (N=18, 24.2 (6.6) years', 'healthy participants']","['sham-tDCS', 'active-tDCS', 'Transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation (tDCS', 'C1-C2:Saline, and C1-C2:Gel and a sham-tDCS condition (M1-SO: Saline']","['cortical excitability', 'Cortical Excitability', 'Cortical recruitment curves and measures of ankle tracking accuracy']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.140648,"The motor evoked potential maximum of the recruitment curve was significantly lower for active than sham-tDCS, but only for the M 1 -SO:Saline combination.","[{'ForeName': 'John Tyler', 'Initials': 'JT', 'LastName': 'Floyd', 'Affiliation': 'University of Central Arkansas, Department of Physical Therapy, Conway, AR, USA 72035.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Lairamore', 'Affiliation': 'Western University of Health Sciences, Department of Physical Therapy Education, Lebanon, OR 97355.'}, {'ForeName': 'Mark Kevin', 'Initials': 'MK', 'LastName': 'Garrision', 'Affiliation': 'University of Central Arkansas, Department of Physical Therapy, Conway, AR, USA 72035.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'University of Florida, Department of Clinical and Health Psychology, Gainesville, FL 32610.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Rainey', 'Affiliation': 'University of Central Arkansas, Department of Health Sciences, Conway, AR, USA 72035.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kiser', 'Affiliation': 'University of Arkansas for Medical Sciences, Department of Physical Medicine and Rehabilitation, Little Rock, AR 72205.'}, {'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR 72205.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mennemeier', 'Affiliation': 'University of Central Arkansas, Department of Physical Therapy, Conway, AR, USA 72035.'}]",Frontiers in neurology and neuroscience research,[]
2497,33274312,"Revacept, an Inhibitor of Platelet Adhesion in Symptomatic Carotid Artery Stenosis: Design and Rationale of a Randomized Phase II Clinical Trial.","Patients with stroke or transient ischemic attacks (TIAs) and internal carotid artery stenosis harbor an increased risk of recurrent stroke especially within 2 weeks after the first event. In addition, the revascularization procedure itself (carotid endarterectomy [CEA] or carotid artery stenting [CAS]) is associated with both clinically apparent and silent brain infarctions, mainly caused by the embolic nature of the ruptured carotid plaque. The glycoprotein VI (GPVI) fusion protein Revacept is a highly specific antithrombotic drug without direct inhibition of systemic platelet function that might reduce periprocedural distal embolization from the vulnerable ruptured plaque located at the internal carotid artery. By shielding collagen at the site of vascular injury, Revacept inhibits plaque-mediated platelet adhesion and aggregation, while not directly affecting systemic hemostasis. In this phase II study, 158 patients with symptomatic carotid artery stenosis with recent TIA or stroke were randomized to receive a single dose of either Revacept (40 or 120 mg) or placebo. All patients were on standard secondary preventive therapy (statins and platelet inhibition) and underwent CEA, CAS, or best medical therapy according to current guidelines. The efficacy of Revacept was evaluated by exploratory assessment of new diffusion-weighted imaging lesions on magnetic resonance imaging after the revascularization procedure; a combination of cardiovascular events (ischemic and hemorrhagic stroke, TIA, myocardial infarction, or coronary intervention) and bleeding complications served to assess clinically critical patients' outcome and safety. This exploratory phase II randomized, double-blind clinical trial provides valuable insights on the safety, tolerability, and efficacy of Revacept in patients with symptomatic carotid artery stenosis.",2020,Patients with stroke or transient ischemic attacks (TIAs) and internal carotid artery stenosis harbor an increased risk of recurrent stroke especially within 2 weeks after the first event.,"['Symptomatic Carotid Artery Stenosis', 'patients with symptomatic carotid artery stenosis', 'Patients with stroke or transient ischemic attacks (TIAs) and internal carotid artery stenosis harbor', 'All patients were on standard secondary preventive therapy (statins and platelet inhibition) and underwent CEA, CAS, or best medical therapy according to current guidelines', '158 patients with symptomatic carotid artery stenosis with recent TIA or stroke']","['Revacept', 'revascularization procedure itself (carotid endarterectomy [CEA] or carotid artery stenting [CAS', 'placebo']","['safety, tolerability, and efficacy of Revacept']","[{'cui': 'C3695086', 'cui_str': 'Symptomatic carotid artery stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0340569', 'cui_str': 'Internal carotid artery stenosis'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0007082', 'cui_str': 'Carcinoembryonic antigen'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C3177552', 'cui_str': 'Revacept'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0014099', 'cui_str': 'Carotid endarterectomy'}, {'cui': 'C0850458', 'cui_str': 'Carotid stent'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3177552', 'cui_str': 'Revacept'}]",158.0,0.278072,Patients with stroke or transient ischemic attacks (TIAs) and internal carotid artery stenosis harbor an increased risk of recurrent stroke especially within 2 weeks after the first event.,"[{'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gröschel', 'Affiliation': 'Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Uphaus', 'Affiliation': 'Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Loftus', 'Affiliation': ""Department of Vascular Surgery, St George's University Hospitals NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Poppert', 'Affiliation': 'Department of Neurology, Klinikum rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Hans Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, Medical Faculty of the University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Zobel', 'Affiliation': 'advanceCOR, Munich, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Münch', 'Affiliation': 'advanceCOR, Munich, Germany.'}]",TH open : companion journal to thrombosis and haemostasis,['10.1055/s-0040-1721078']
2498,33274309,Pomegranate Metabolites Impact Tryptophan Metabolism in Humans and Mice.,"Background
We showed that pomegranate juice (PomJ) can help to maintain memory in adults aged >50 y. The mechanism for this effect is unknown, but might involve Trp and its metabolites, which are important in brain function.
Objectives
We aimed to test the hypothesis that PomJ and its metabolites ellagic acid (EA) and urolithin A (UA) affect Trp metabolism.
Methods
Stool and plasma from a cohort [11 PomJ, 9 placebo drink (PL)] of subjects enrolled in our double-blind, placebo-controlled trial (NCT02093130) were collected at baseline and after 1 y of PomJ or PL consumption. In a mouse study, cecum and serum were collected from DBA/2J mice receiving 8 wk of dietary 0.1% EA or UA supplementation. Trp metabolites and intestinal microbiota were analyzed by LC-MS and 16S rRNA gene sequencing, respectively.
Results
In the human study, the change in the plasma Trp metabolite indole propionate (IPA) over 1 y was significantly different between PomJ and PL groups ( P = 0.03). In serum of experimental mice, we observed a 230% increase of IPA by EA but not UA, a 54% increase of indole sulfate by UA but not EA, and 43% and 34% decreases of kynurenine (KYN) by EA and UA, respectively. In cecum, there was a 32% decrease of Trp by UA but not EA, and an 86% decrease of KYN by EA but not UA ( P < 0.05). The abundance of 2 genera, Shigella and Catenibacterium , was reduced by PomJ in humans as well as by UA in mice, and their abundance was negatively associated with blood IPA in humans and mice ( P < 0.05).
Conclusions
These results suggest a novel mechanism involving the regulation of host and microbial Trp metabolism that might contribute to the health benefits of ellagitannins and EA-enriched food, such as PomJ.",2020,"The abundance of 2 genera, Shigella and Catenibacterium , was reduced by PomJ in humans as well as by UA in mice, and their abundance was negatively associated with blood IPA in humans and mice ( P ","['adults aged ', 'Humans and Mice']","['placebo', 'PomJ and its metabolites ellagic acid (EA) and urolithin A (UA', 'placebo drink (PL', 'pomegranate juice (PomJ']","['abundance of 2 genera, Shigella and Catenibacterium', 'plasma Trp metabolite indole propionate (IPA', 'indole sulfate', 'Trp metabolites and intestinal microbiota', 'IPA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1327962', 'cui_str': 'POMEGRANATE JUICE'}, {'cui': 'C0013900', 'cui_str': 'Ellagic Acid'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0013371', 'cui_str': 'Infection by Shigella'}, {'cui': 'C1065645', 'cui_str': 'Catenibacterium'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0123496', 'cui_str': 'indole propionate'}, {'cui': 'C0021236', 'cui_str': 'indole'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.0958141,"The abundance of 2 genera, Shigella and Catenibacterium , was reduced by PomJ in humans as well as by UA in mice, and their abundance was negatively associated with blood IPA in humans and mice ( P ","[{'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yuanqiang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Medicinal Chemical Biology, College of Pharmacy, and Tianjin Key Laboratory of Molecular Drug Research, Nankai University, Tianjin, China.'}, {'ForeName': 'Rupo', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Henning', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yajing', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Health Cultivation of the Ministry of Education, Beijing University of Chinese Medicine , Beijing, China.'}, {'ForeName': 'Tianyu', 'Initials': 'T', 'LastName': 'Qing', 'Affiliation': 'Key Laboratory of Health Cultivation of the Ministry of Education, Beijing University of Chinese Medicine , Beijing, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Siddarth', 'Initials': 'S', 'LastName': 'Prabha', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Rashi', 'Initials': 'R', 'LastName': 'Ojha', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Gary W', 'Initials': 'GW', 'LastName': 'Small', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Heber', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa165']
2499,33273982,Inhalation of low-dose desflurane prevents the hemodynamic instability caused by target-controlled infusion of remifentanil and propofol during laparoscopic gynecological surgery: A randomized controlled trial.,"The objective of the present study was to determine whether the addition of inhaled desflurane is superior to remifentanil-propofol total intravenous anesthesia (TIVA) alone in patients undergoing laparoscopic gynecological surgery. A total of 60 patients who were scheduled to undergo laparoscopic gynecological surgery were prospectively enrolled and randomly allocated to receive either propofol-remifentanil (PR group; n=30) or combined propofol-remifentanil and low-dose desflurane (PRD group; n=30) for the maintenance of anesthesia. Hemodynamics [mean arterial pressure (MAP); heart rate (HR)], recovery parameters and complications were recorded. The results of the present study indicated that the addition of desflurane significantly reduced the amount of propofol and remifentanil that was administered in the PRD group, compared with that in the PR group. MAP and HR were significantly higher at T3 (5 min post-pneumoperitoneum), but significantly lower at T4 (removal of pneumoperitoneum needle) and T5 (post-operation immediately) in the PR group, compared with the PRD group. Moreover, MAP and HR were significantly altered at multiple time points within the PR group; however, they were relatively stable in the PRD group. There were no significant differences in the recovery parameters and complications between the two groups. In conclusion, combining low-dose desflurane with PR may represent an efficient anesthesia regimen to prevent the hemodynamic instability of TIVA in patients undergoing laparoscopic gynecological surgery.",2021,"MAP and HR were significantly higher at T3 (5 min post-pneumoperitoneum), but significantly lower at T4 (removal of pneumoperitoneum needle) and T5 (post-operation immediately) in the PR group, compared with the PRD group.","['laparoscopic gynecological surgery', '60 patients who were scheduled to undergo laparoscopic gynecological surgery', 'patients undergoing laparoscopic gynecological surgery']","['desflurane', 'remifentanil-propofol total intravenous anesthesia (TIVA) alone', 'propofol-remifentanil (PR group; n=30) or combined propofol-remifentanil and low-dose desflurane (PRD group; n=30) for the maintenance of anesthesia', 'remifentanil and propofol', 'inhaled desflurane']","['MAP and HR', 'Hemodynamics [mean arterial pressure (MAP); heart rate (HR)], recovery parameters and complications', 'recovery parameters and complications', 'hemodynamic instability', 'hemodynamic instability of TIVA']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0853213', 'cui_str': 'Maintenance of anaesthesia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}]",60.0,0.0477906,"MAP and HR were significantly higher at T3 (5 min post-pneumoperitoneum), but significantly lower at T4 (removal of pneumoperitoneum needle) and T5 (post-operation immediately) in the PR group, compared with the PRD group.","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, Changchun, Jilin 130041, P.R. China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, Changchun, Jilin 130041, P.R. China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, Changchun, Jilin 130041, P.R. China.'}, {'ForeName': 'Xufang', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, The Second Hospital of Jilin University, Changchun, Jilin 130041, P.R. China.'}]",Experimental and therapeutic medicine,['10.3892/etm.2020.9486']
2500,33273940,"Penicillin in oral aphthosis, new insight for an old drug: A randomized, double-blind, controlled clinical trial.","Background
Oral aphthosis is a painful ulceration of mucus membranes characterized by round or oval lesions with central necrosis and erythematous haloes. Due to unknown etiology, treatment is highly controversial and based mainly on individual experience. The aim of this study was to investigate the safety and efficacy of topical penicillin 6.3.3 for the treatment of recurrent aphthous stomatitis.
Materials and Methods
This randomized, double-blind, controlled clinical trial was done in Shahid Sadoughi Hospital Clinic in Yazd (2011-2012). Fifty patients aged 15-45 with recurrent oral aphthosis were randomly divided into two groups. After obtaining informed consents, patients in the case and control groups were treated (four times/day for a week), respectively, by topical penicillin 6.3.3 powder and placebo in similar vial. The patients who had acute-onset oral aphthae (≤48 h of appearance) with diameter ≥5 mm were included. History of sensitivity to β-lactam antibiotics and cephalosporin; spontaneous recovery during <5 days in previous episodes; concurrent systemic, infectious, or any autoimmune disorders; history of taking drugs (local or systemic) from 2 weeks prior to presentation; alcohol or drug abuse; smoking cigarette or tobacco; and poor compliance were exclusion criteria. Patients were examined in days 0, 3, 6, and 8. The main outcome measure was reduction in the median pain. Burning, pain, erythema, and inflammation were recorded as complications.
Results
Of 25 patients receiving penicillin, 13 were female and 12 were male. Regarding the pain score (mean difference = 1.6 vs. 0.88, P = 0.012) and size of aphthus (mean difference = 9.43 vs. 1.24, P = 0.008), patients who received penicillin had significantly better results than the placebo group on day 8 after the treatment. The mean duration to healing was 3 days for penicillin group and 6 days for placebo group ( P = 0.016). No topical or systemic adverse effects were observed.
Conclusion
Our study showed a dramatic response to topical penicillin with respect to placebo. Hence, it seems that penicillin could be a safe and effective option in managing oral aphthosis.",2020,The mean duration to healing was 3 days for penicillin group and 6 days for placebo group ( P = 0.016).,"['Fifty patients aged 15-45 with recurrent oral aphthosis', 'recurrent aphthous stomatitis', '25 patients receiving penicillin, 13 were female and 12 were male', 'patients who had acute-onset oral aphthae (≤48 h of appearance) with diameter ≥5 mm were included', 'Shahid Sadoughi Hospital Clinic in Yazd (2011-2012']","['topical penicillin 6.3.3 powder and placebo', 'placebo', 'β-lactam antibiotics and cephalosporin', 'penicillin', 'Penicillin', 'topical penicillin']","['systemic adverse effects', 'Burning, pain, erythema, and inflammation', 'pain score', 'safety and efficacy', 'median pain', 'mean duration to healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016514', 'cui_str': 'Foot and mouth disease'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038363', 'cui_str': 'Aphtha'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C3536856', 'cui_str': 'Cephalosporin antibiotic product'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",50.0,0.482733,The mean duration to healing was 3 days for penicillin group and 6 days for placebo group ( P = 0.016).,"[{'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Owlia', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Mirzadeh', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Golbarg', 'Initials': 'G', 'LastName': 'Mehrpoor', 'Affiliation': 'Department of Internal Medicine, Division of Rheumatology, Alborz University of Medical Sciences, Karaj, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_748_19']
2501,33273938,Ultrasound-guided ethanol injection for the treatment of parathyroid adenoma: A prospective self-controlled study.,"Background
Parathyroidectomy, the standard treatment of primary hyperparathyroidism (PHP) due to parathyroid adenoma, is not suitable for all patients. We evaluated the efficacy of ultrasound-guided ethanol ablation of parathyroid adenoma in a group of patients with PHP.
Materials and Methods
In a prospective self-controlled trial, 39 patients with parathyroid adenoma, who were not candidates for surgery, were enrolled. Ethanol injections were performed by two experienced interventional radiologists under the guidance of real-time ultrasonography. Adenoma size changes were assessed at about 1 month later. Serum levels of parathyroid hormone, calcium, phosphate, 25-OH Vitamin D, and alkaline phosphatase were evaluated at the baseline, 1, 3, 6, and 12 months after the injections. The treatment effects on outcome variables were assessed by repeated measures analysis.
Results
Volume of the adenomas decreased during the study period from 1.87±6.45 cm 3 to 0.38± 0.48cm 3 ( P < 0.001). Corrected serum calcium levels decreased from 10.40 ± 0.96 mg/dl to 8.82 ± 0.58 mg/dl ( P < 0.001), and remained stable during one year follow-up. Serum levels of parathyroid hormone decreased gradually from 129.85 ± 63.37 to 72.58 ± 53.86 pg/mL after 3 months and to 44.78 ± 28.04 pg/mL after 1 year ( P < 0.001). Overall, 46% of the patients improved after 1 month of ethanol ablation therapy which increased to 84.5% during 1-year follow-up. No major complications were observed.
Conclusion
The current study showed the efficacy of ultrasound-guided ethanol injection in PHP and may be considered as a suitable alternative treatment in patients who are not candidates for the surgery. It has also a good safety profile without major complications if performed by experienced hands.",2020,Serum levels of parathyroid hormone decreased gradually from 129.85 ± 63.37 to 72.58 ± 53.86 pg/mL after 3 months and to 44.78 ± 28.04 pg/mL after 1 year ( P < 0.001).,"['parathyroid adenoma', '39 patients with parathyroid adenoma, who were not candidates for surgery, were enrolled', 'patients who are not candidates for the surgery', 'patients with PHP']","['ultrasound-guided ethanol injection', 'ethanol ablation therapy', 'ultrasound-guided ethanol ablation of parathyroid adenoma', 'Ultrasound-guided ethanol injection', 'Ethanol injections']","['Adenoma size changes', 'Serum levels of parathyroid hormone, calcium, phosphate, 25-OH Vitamin D, and alkaline phosphatase', 'Serum levels of parathyroid hormone', 'Volume of the adenomas', 'Corrected serum calcium levels']","[{'cui': 'C0262587', 'cui_str': 'Parathyroid adenoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0221002', 'cui_str': 'Primary hyperparathyroidism'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4307245', 'cui_str': 'Ethanol Injection'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0262587', 'cui_str': 'Parathyroid adenoma'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0455288', 'cui_str': 'Corrected serum calcium measurement'}]",39.0,0.0342098,Serum levels of parathyroid hormone decreased gradually from 129.85 ± 63.37 to 72.58 ± 53.86 pg/mL after 3 months and to 44.78 ± 28.04 pg/mL after 1 year ( P < 0.001).,"[{'ForeName': 'Amir Ali', 'Initials': 'AA', 'LastName': 'Yazdani', 'Affiliation': 'Jam Medical Imaging and Interventional Radiology Center, Isfahan, Iran.'}, {'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Khalili', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Siavash', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Shemian', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Goharian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Karimifar', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Tavakoli', 'Affiliation': 'Arman Medical Imaging and Interventional Radiology Institute, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Yazdi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_553_19']
2502,33273933,Evaluation of treatment plan by three-period pulses of high-dose dexamethasone among patients with primary immune thrombocytopenia on platelet count response and adverse events: A randomized Clinical trial.,"Background
Primary immune thrombocytopenia (ITP) decreases platelet count as well as increases the risk of bleeding due to platelet destruction in an autoimmune disorder. For many years, prednisone (PDN) has been the standard first-line treatment in ITP practical guidelines. The current randomized clinical trial compared the efficacy of treatments between three-pulse high-dose dexamethasone (HD-DXM) and the traditional PDN regimen among untreated patients with ITP in accordance with platelet count responses and adverse events.
Materials and Methods
We randomly assigned eligible patients with ITP to receive PDN or a three-pulse regimen of HD-DXM. In the HD-DXM group, 40 mg of DXM was administered intravenously for 4 consecutive days and was repeated in 14-day intervals for three pulses of treatment. Patients in the PDN group received 1.0 mg/kg of PDN orally per day for 4 consecutive weeks. The Mann-Whitney test was used for comparing the median of platelet count between the two groups, and logistic regression was used to evaluate odds ratio (OR) in the response rate of platelet count between the two groups. Blindness was not applied for both patients and physicians.
Results
The initial response rate of platelet count in the HD-DXM group was significantly higher than the PDN group (P < 0.05). According to the results of logistic regression, the initial and sustained response (SR) rate of platelet count in the HD-DXM group was significantly higher than the PDN group (OR: 5.68 and 4.17, respectively, P < 0.05). In fact, in the HD-DXM group, more patients reached SR after the 8-month follow-up (88.9% vs. 66.6%, P < 0.05).
Conclusion
In patients with ITP disease who have not received any kind of treatment, HD-DXM was more effective than conventional PDN therapy.",2020,"In patients with ITP disease who have not received any kind of treatment, HD-DXM was more effective than conventional PDN therapy.","['patients with primary immune thrombocytopenia', 'eligible patients with ITP to receive', 'patients with ITP disease who have not received any kind of treatment', 'untreated patients with ITP in accordance with platelet count responses and adverse events']","['prednisone (PDN', 'dexamethasone (HD-DXM', 'HD-DXM', 'PDN', 'DXM', 'PDN or a three-pulse regimen of HD-DXM', 'dexamethasone']","['initial response rate of platelet count', 'Blindness', 'initial and sustained response (SR) rate of platelet count', 'platelet count response and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0367074,"In patients with ITP disease who have not received any kind of treatment, HD-DXM was more effective than conventional PDN therapy.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Hematology-Oncology, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Seyyideh Forough', 'Initials': 'SF', 'LastName': 'Hosseini', 'Affiliation': 'Cancer Prevention Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saeid Rezaei', 'Initials': 'SR', 'LastName': 'Jouzdani', 'Affiliation': 'Department of Internal Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_257_19']
2503,33273931,Anti-inflammatory properties of combined aquatic extract of Ferulago angulata boiss with aerobic exercise on pro-inflammatory indices in obese males.,"Background
The application of supplements, herbal extracts, and exercise training for treatment of diseases and reducing chronic inflammation has been increased progressively among people. Thus, the aim of this investigation was to study the combined aquatic extract of Ferulago angulata boiss with aerobic exercise on pro-inflammatory indices in obese males.
Materials and Methods
In this semi-experimental study, forty young obese men (mean and standard deviation of age 34.59 ± 2.24 years, body mass index (BMI) 33.14 ± 2.75 kg/m 2 ) were selected by purposed sampling and were randomly divided into four equal groups ( n = 10), training, training-supplementation, supplementation, and control. Participants in the supplementary groups received 50 mg/ml F. angulata extracts daily for 12 weeks. Aerobic training program included 12 weeks of training, 3 sessions/week, and each session was 20 min at 60%-%-70% of maximal oxygen consumption. Blood samples were taken from the participants 48 h before and after the intervention in fasting state. Data were analyzed using dependent t -test, one-way analysis of variance, and post hoc Tukey test at a significant level of P < 0.05.
Results
After 12 weeks of exercise and supplementation, levels of interleukin (IL)-6 ( P = 0.001), IL-18 ( P = 0.03), IL-1 β ( P = 0.001), tumor necrosis factor alpha ( P = 0.001), weight ( P = 0.001), BMI ( P = 0.001), body fat percent ( P = 0.001), and waist-hip ratio ( P = 0.001) decreased significantly and the mean changes of these indicators in training + supplementation group were significantly augmented as compared to the other three groups.
Conclusion
It appears that aerobic training plus F. angulata extract consumption have better effect on improvement of serum inflammatory factors in obese young men.",2020,"After 12 weeks of exercise and supplementation, levels of interleukin (IL)-6 ( P = 0.001), IL-18 ( P = 0.03), IL-1 β ( P = 0.001), tumor necrosis factor alpha ( P = 0.001), weight ( P = 0.001), BMI ( P = 0.001), body fat percent ( P = 0.001), and waist-hip ratio ( P = 0.001) decreased significantly and the mean changes of these indicators in training + supplementation group were significantly augmented as compared to the other three groups.
","['forty young obese men (mean and standard deviation of age 34.59 ± 2.24 years, body mass index (BMI) 33.14 ± 2.75 kg/m 2 ) were selected by purposed sampling', 'obese young men', 'obese males']","['herbal extracts, and exercise training', 'aerobic exercise', 'training, training-supplementation, supplementation, and control']","['levels of interleukin (IL)-6', 'weight', 'body fat percent', 'waist-hip ratio', 'BMI', 'IL-1 β', 'tumor necrosis factor alpha', 'serum inflammatory factors', 'IL-18']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}]",40.0,0.0587331,"After 12 weeks of exercise and supplementation, levels of interleukin (IL)-6 ( P = 0.001), IL-18 ( P = 0.03), IL-1 β ( P = 0.001), tumor necrosis factor alpha ( P = 0.001), weight ( P = 0.001), BMI ( P = 0.001), body fat percent ( P = 0.001), and waist-hip ratio ( P = 0.001) decreased significantly and the mean changes of these indicators in training + supplementation group were significantly augmented as compared to the other three groups.
","[{'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Zakavi', 'Affiliation': 'Department of Public Health, Abadan Faculty of Medical Sciences, Abadan University of Medical Sciences, Abadan, Iran.'}, {'ForeName': 'Shila', 'Initials': 'S', 'LastName': 'Nayebifar', 'Affiliation': 'Department of Sport Sciences, Faculty of Educational Sciences and Psychology, University of Sistan and Baluchestan, Zahedan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Sport Sciences, Faculty of Literature and Humanities, University of Zabol, Zabol, Iran.'}, {'ForeName': 'Aliasghar', 'Initials': 'A', 'LastName': 'Valipour', 'Affiliation': 'Department of Public Health, Abadan Faculty of Medical Sciences, Abadan University of Medical Sciences, Abadan, Iran.'}]",Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences,['10.4103/jrms.JRMS_475_19']
2504,33273925,"Comparison of MTA, CEM Cement, and Biodentine as Coronal Plug during Internal Bleaching: An In Vitro Study.","Background
Internal bleaching is a choice of treatment in discolored endodontically treated teeth. Cervical root resorption is one of the important complications of this treatment. A suggested procedure to prevent this type of resorption is using a coronal barrier under the bleaching materials. The aim of the study was to compare the microleakage of mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM) cement, and Biodentine.
Materials and Methods
In this in vitro study, a total of 60 single canal incisors were included. They were randomly divided into three experimental groups ( n = 16), one positive control group ( n = 6), and one negative control group ( n = 6). Coronal portion of the canals in the experimental groups was sealed with 3 mm of MTA, CEM cement, or Biodentine as a coronal barrier. After 3 days, specimens were bleached. A fresh Enterococcus faecalis suspension was added to the samples. The culture tubes were observed for 45 days, and the daily turbidity was recorded. Statistical analysis was accomplished by the Kaplan-Meier test and SPSS 22.
Results
All positive samples showed turbidity, whereas none of the negative samples allowed bacterial leakage. Results showed no significant difference between MTA, CEM cement, and Biodentine groups. ( P value = 0.304, 0.695, and 0.217). The bacterial microleakage for the two groups also did not show significant differences.
Conclusions
CEM cement and Biodentine showed promising results as coronal plug, and clinical studies are needed to test these materials with MTA for avoiding microleakage in internal bleaching treatment.",2020,"Results showed no significant difference between MTA, CEM cement, and Biodentine groups.",['60 single canal incisors were included'],"['MTA, CEM Cement, and Biodentine as Coronal Plug during Internal Bleaching', 'mineral trioxide aggregate (MTA), calcium-enriched mixture (CEM) cement, and Biodentine', '\n\n\nInternal bleaching']","['daily turbidity', 'bacterial microleakage']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C3502756', 'cui_str': 'biodentine'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0182324', 'cui_str': 'Plug'}, {'cui': 'C0205102', 'cui_str': 'Internal'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319582', 'cui_str': 'Turbidity (property)'}]",60.0,0.0198711,"Results showed no significant difference between MTA, CEM cement, and Biodentine groups.","[{'ForeName': 'Paridokht', 'Initials': 'P', 'LastName': 'Zarean', 'Affiliation': 'Dental Implant Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Parichehr', 'Initials': 'P', 'LastName': 'Zarean', 'Affiliation': 'Dental Implant Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Ravaghi', 'Affiliation': 'Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zare Jahromi', 'Affiliation': 'Department of Endodontics, Isfahan (Khorasgan) Branch, Islamic Azad University, Isfahan, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Sadrameli', 'Affiliation': 'Private Practice, Chicago, Illinois, USA.'}]",International journal of dentistry,['10.1155/2020/8896740']
2505,33273914,Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial.,"Background
The Trachyspermum ammi L. (TA), Anethum graveolens L. (AG), and Zataria multiflora Boiss (ZM) herbal oils are among the most used herbal products in traditional medicine as the antiseptic, anesthetic, carminative, and antispasmodic. However, there are no clinical studies to evaluate the efficacy of the herbs mentioned in the treatment of functional dyspepsia (FD). This study was designed to appraise the efficacy and safety of a novel herbal medicine consisting of ZM, AG, and TA essential oils compared to omeprazole in FD treatment.
Methods
The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in control and intervention arms received omeprazole 20 mg once a day and 250 mg soft-gel capsules containing 180 mg of essential oils of ZM, AG, and TA twice a day for two weeks, respectively. The primary outcome was the sufficient response rate in the postprandial distress syndrome (PDS) and/or epigastric pain syndrome (EPS) at the end of the intervention. Secondary outcomes were the improvement rate in the PDS, EPS, Gastrointestinal Symptom Rating Scale (GSRS), and quality of life scores. Also, safety and tolerability were assessed.
Results
The within-group comparison of EPS, PDS, total GSRS, GSRS Pain, and GSRS Dyspepsia scores with that at the end of the treatment indicated a significant reduction in both control and intervention groups ( p < 0.001). However, after two weeks of treatment, the herbal medication and omeprazole arms were significantly different in the sufficient response rate based on PDS ( p < 0.01) and EPS ( p < 0.05) scores (78.3% (18/23) and 73.7% (14/19) in the intervention group vs. 36.4% (8/22) and 40.9% (9/22) in the control group). Also, the mean reduction in EPS ( p < 0.05), PDS ( p < 0.01), and GSRS ( p < 0.001) scores after treatment was significantly higher in the intervention group than control group.
Conclusion
Based on the study findings, this herbal medicine can be considered as an appropriate treatment of FD. However, a larger multicenter trial is needed to confirm the results of the trial.",2020,"Also, the mean reduction in EPS ( p < 0.05), PDS ( p < 0.01), and GSRS ( p < 0.001) scores after treatment was significantly higher in the intervention group than control group.
","['Functional Dyspepsia', 'parallel groups in Iran']","['novel herbal medicine consisting of ZM, AG, and TA essential oils', 'omeprazole', 'omeprazole 20\u2009mg once a day and 250\u2009mg soft-gel capsules containing 180\u2009mg of essential oils of ZM, AG, and TA', 'Novel Herbal Medicine and Omeprazole']","['mean reduction in EPS', 'L. (TA', 'safety and tolerability', 'PDS', 'GSRS', 'sufficient response rate based on PDS', 'improvement rate in the PDS, EPS, Gastrointestinal Symptom Rating Scale (GSRS), and quality of life scores', 'EPS, PDS, total GSRS, GSRS Pain, and GSRS Dyspepsia scores', 'sufficient response rate in the postprandial distress syndrome (PDS) and/or epigastric pain syndrome (EPS', 'EPS']","[{'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0988268', 'cui_str': 'Omeprazole 20 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}]",,0.115896,"Also, the mean reduction in EPS ( p < 0.05), PDS ( p < 0.01), and GSRS ( p < 0.001) scores after treatment was significantly higher in the intervention group than control group.
","[{'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Bordbar', 'Affiliation': 'Student Research Committee, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohammad Bagher', 'Initials': 'MB', 'LastName': 'Miri', 'Affiliation': 'Department of Gastroenterology, Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Omidi', 'Affiliation': 'Department of Pharmacology and Toxicology, Faculty of Pharmacy and Pharmaceutical Sciences, Fertility and Infertility Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shoja', 'Affiliation': 'Infectious and Tropical Diseases Research Center, Research Institute for Health, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Akhavan', 'Affiliation': 'Pharmaceutical Sciences Research Center, Department of Medicinal Chemistry, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Gastroenterology research and practice,['10.1155/2020/5152736']
2506,33273851,"Comparing Analgesic Effect of Intravenous Fentanyl, Femoral Nerve Block and Fascia Iliaca Block During Spinal Anesthesia Positioning in Elective Adult Patients Undergoing Femoral Fracture Surgery: a Randomized Controlled Trial.","Background
Femoral fracture is the most painful bone injury and performing spinal anesthesia is extremely challenging due to very poor positioning unless we have a very good mode of analgesia. Intravenous strong opioids are commonly used but to date nerve blocks are also being utilized. The reliability and effectiveness of the aforementioned methods are not conclusive to practice worldwide. The objective of the study was to compare the analgesic effect of intravenous fentanyl, femoral nerve block (FNB) and fascia iliaca block (FICB) during positioning patients with femoral fracture for spinal anesthesia.
Methods
A randomized controlled trial study was conducted on 72 elective adult patients with femoral fracture aged 18-65 years and ASA I and II those were allocated randomly into three groups. The intravenous fentanyl (IVFE) group received 1µg/kg IV fentanyl, FNB group received nerve stimulator guided FNB with 30 mL of 1% lidocaine with adrenaline and FICB group received FICB with 30 mL of 1% lidocaine with adrenaline. Pain intensity in numeric rating score (NRS), time to perform spinal anesthesia, quality of positioning and patient acceptance were assessed. SPSS version 26 and Kruskal-Wallis test were used to analyze data and p value <0.05 was considered significant.
Results
NRS Pain score during positioning was significantly lower in FNB and FICB groups than IVFE group [median (IQR)]; 2 (1-2.5), 2 (2-3)) vs. 3 (3-4) respectively; P<0.001 and P=0.001. However, FNB and FICB groups were not significantly different with (P=1.000). Time to perform spinal anesthesia was significantly longer in IVFE group 9.5 (9-10) minutes than both FNB and FICB groups 7 (6-8), 8 (6-8) respectively, P<0.001. The quality of positioning was significantly lower in the IVFE group than both FNB and FICB groups (P<0.001).
Conclusion
Preoperative FNB and FICB reduce pain score during positioning, shorten time to perform spinal anesthesia, better patient positioning and higher patient acceptance in a patient undergoing elective femoral bone fracture surgery.
Trial Registration
Pan African Clinical Trial Registry, PACTR202006669166858, registered on June 19, 2020. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12127.",2020,"The quality of positioning was significantly lower in the IVFE group than both FNB and FICB groups (P<0.001).
","['Undergoing Femoral Fracture Surgery', '72 elective adult patients with femoral fracture aged 18-65 years and ASA I and II those', 'positioning patients with femoral fracture for spinal anesthesia', 'Elective Adult Patients', 'patient undergoing elective femoral bone fracture surgery']","['fentanyl (IVFE', 'IVFE', 'lidocaine with adrenaline and FICB', 'FICB with 30 mL of 1% lidocaine with adrenaline', 'Intravenous Fentanyl, Femoral Nerve Block and Fascia Iliaca Block', 'intravenous fentanyl, femoral nerve block (FNB) and fascia iliaca block (FICB']","['NRS Pain score', 'quality of positioning', 'pain score', 'analgesic effect', 'Pain intensity in numeric rating score (NRS), time to perform spinal anesthesia, quality of positioning and patient acceptance', 'Time to perform spinal anesthesia']","[{'cui': 'C0015802', 'cui_str': 'Fracture of femur'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1561964', 'cui_str': 'Positioning patient'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0394739', 'cui_str': 'Local anesthetic femoral nerve block'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",72.0,0.198331,"The quality of positioning was significantly lower in the IVFE group than both FNB and FICB groups (P<0.001).
","[{'ForeName': 'Melaku', 'Initials': 'M', 'LastName': 'Bantie', 'Affiliation': 'Debre Berhan University, College of Medicine and Health Science, Debre Birhan, Ethiopia.'}, {'ForeName': 'Simeneh', 'Initials': 'S', 'LastName': 'Mola', 'Affiliation': 'Dilla University, College of Medicine and Health Science, Dilla, Ethiopia.'}, {'ForeName': 'Timsel', 'Initials': 'T', 'LastName': 'Girma', 'Affiliation': 'Dilla University, College of Medicine and Health Science, Dilla, Ethiopia.'}, {'ForeName': 'Zemedu', 'Initials': 'Z', 'LastName': 'Aweke', 'Affiliation': 'Dilla University, College of Medicine and Health Science, Dilla, Ethiopia.'}, {'ForeName': 'Derartu', 'Initials': 'D', 'LastName': 'Neme', 'Affiliation': 'Dilla University, College of Medicine and Health Science, Dilla, Ethiopia.'}, {'ForeName': 'Abebayehu', 'Initials': 'A', 'LastName': 'Zemedkun', 'Affiliation': 'Dilla University, College of Medicine and Health Science, Dilla, Ethiopia.'}]",Journal of pain research,['10.2147/JPR.S282462']
2507,33273369,"Efficacy and safety of Shexiang Baoxin pill (MUSKARDIA) in patients with stable coronary artery disease: a multicenter, double-blind, placebo-controlled phase IV randomized clinical trial.","BACKGROUND
The Shexiang Baoxin Pill (MUSKARDIA) has been used for treating coronary artery disease (CAD) and angina for more than 30 years in China. Nevertheless, methodologically sound trials on the use of MUSKARDIA in CAD patients are scarce. The aim of the study is to determine the effects of MUSKARDIA as an add-on to optimal medical therapy (OMT) in patients with stable CAD.
METHODS
A total of 2674 participants with stable CAD from 97 hospitals in China were randomized 1:1 to a MUSKARDIA or placebo group for 24 months. Both groups received OMT according to local tertiary hospital protocols. The primary outcome was the occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. Secondary outcomes included all-cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency.
RESULTS
In all, 99.7% of the patients were treated with aspirin and 93.0% with statin. After 2 years of treatment, the occurrence of MACEs was reduced by 26.9% in the MUSKARDIA group (MUSKARDIA: 1.9% vs. placebo: 2.6%; odds ratio = 0.80; 95% confidence interval: 0.45-1.07; P = 0.2869). Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362). Other secondary endpoints were similar between the two groups. The rates of adverse events were also similar between the two groups (MUSKARDIA: 17.7% vs. placebo: 17.4%, P = 0.8785).
CONCLUSIONS
As an add-on to OMT, MUSKARDIA is safe and significantly reduces angina frequency in patients with stable CAD. Moreover, the use of MUSKARDIA is associated with a trend toward reduced MACEs in patients with stable CAD. The results suggest that MUSKARDIA can be used to manage patients with CAD.
TRIAL REGISTRATION
No. ChiCTR-TRC-12003513.",2020,Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362).,"['patients with CAD', '2674 participants with stable CAD from 97 hospitals in China', 'coronary artery disease (CAD) and angina for more than 30 years in China', 'patients with stable CAD', 'patients with stable coronary artery disease']","['placebo', 'OMT', 'medical therapy (OMT', 'Shexiang Baoxin pill (MUSKARDIA', 'aspirin', 'statin']","['angina frequency', 'rates of adverse events', 'occurrence of a major adverse cardiovascular event (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke', 'Angina frequency', 'Efficacy and safety', 'occurrence of MACEs', 'cause mortality, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or heart failure, peripheral revascularization, angina stability and angina frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C2351547', 'cui_str': 'shexiang baoxin'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",2674.0,0.286085,Angina frequency was significantly reduced in the MUSKARDIA group at 18 months (P = 0.0362).,"[{'ForeName': 'Jun-Bo', 'Initials': 'JB', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Jing-Min', 'Initials': 'JM', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai 200032, China.'}, {'ForeName': 'Hai-Ming', 'Initials': 'HM', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Huashan Hospital, Fudan University, Shanghai 200040, China.'}, {'ForeName': 'Fu-Sui', 'Initials': 'FS', 'LastName': 'Ji', 'Affiliation': 'Department of Cardiology, Beijing Hospital of the Ministry of Health, Beijing 100730, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Yu-Lan', 'Initials': 'YL', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': ""Department of Cardiology, The Center Hospital of Ma'anshan, Anhui, Liaoning 243000, China.""}, {'ForeName': 'Yuan-Zhe', 'Initials': 'YZ', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, The Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning 110032, China.'}, {'ForeName': 'Ying-Wu', 'Initials': 'YW', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Tianjin Third Central Hospital, Tianjin 300170, China.'}, {'ForeName': 'Sheng-Huang', 'Initials': 'SH', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Ningbo First Hospital, Ningbo, Zhejiang 315010, China.'}, {'ForeName': 'Sheng-Hu', 'Initials': 'SH', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Northern Jiangsu People's Hospital, Yangzhou, Jiangsu 210036, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, China-Japan Union Hospital of Jilin University, Changchun, Jilin 130031, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of University of South China, Hengyang, Hunan 421000, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong 250355, China.'}, {'ForeName': 'Zi-Shan', 'Initials': 'ZS', 'LastName': 'Hou', 'Affiliation': ""Department of Cardiology, Linyi People's Hospital, Linyi, Shandong 276000, China.""}]",Chinese medical journal,['10.1097/CM9.0000000000001257']
2508,33273351,"The Efficacy of Liposomal Bupivacaine On Postoperative Pain Following Abdominal Wall Reconstruction: A Randomized, Double-Blind, Placebo-Controlled Trial.","OBJECTIVE
To study the efficacy of liposomal bupivacaine on postoperative opioid requirement and pain following abdominal wall reconstruction.
SUMMARY BACKGROUND DATA
Despite the widespread use of liposomal bupivacaine in transversus abdominis plane block, there is inadequate evidence demonstrating its efficacy in open abdominal wall reconstruction. We hypothesized that liposomal bupivacaine plane block would result in decreased opioid requirements compared to placebo in the first 72 hours after surgery.
METHODS
This was a single-center double-blind, placebo-controlled prospective study conducted between July 2018 and November 2019. Adult patients (at least 18 years of age) undergoing open, elective, ventral hernia repairs with mesh placed in the retromuscular position were enrolled. Patients were randomized to surgeon-performed transversus abdominis plane block with liposomal bupivacaine, simple bupivacaine, or normal saline (placebo). The main outcome was opioid requirements in the first 72 hours after surgery. Secondary outcomes included total inpatient opioid use, pain scores determined using a 100 mm visual analog scale, length of hospital stay, and patient-reported quality of life.
RESULTS
Of the 164 patients that were included in the analysis, 57 patients received liposomal bupivacaine, 55 patients received simple bupivacaine and 52 received placebo. There were no differences in the total opioid used in the first 72 hours after surgery as measured by morphine milligram equivalents when liposomal bupivacaine was compared to simple bupivacaine and placebo (325 ± 225 vs. 350 ± 284 vs. 310 ± 272, respectively, p = 0.725). Similarly, there were no differences in total inpatient opioid use, pain scores, length of stay, and patient-reported quality of life.
CONCLUSIONS
There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared to simple bupivacaine and placebo for open abdominal wall reconstruction.",2020,There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared to simple bupivacaine and placebo for open abdominal wall reconstruction.,"['July 2018 and November 2019', 'Abdominal Wall Reconstruction', 'Adult patients (at least 18 years of age) undergoing open, elective, ventral hernia repairs with mesh placed in the retromuscular position were enrolled', 'transversus abdominis plane block', '164 patients that were included in the analysis']","['surgeon-performed transversus abdominis plane block with liposomal bupivacaine, simple bupivacaine, or normal saline (placebo', 'placebo', 'bupivacaine', 'liposomal bupivacaine', 'Placebo', 'Liposomal Bupivacaine', 'bupivacaine and placebo']","['opioid requirements', 'total inpatient opioid use, pain scores, length of stay, and patient-reported quality of life', 'total inpatient opioid use, pain scores determined using a 100\u200amm visual analog scale, length of hospital stay, and patient-reported quality of life', 'Postoperative Pain', 'total opioid']","[{'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",,0.616986,There are no apparent clinical benefits to using liposomal bupivacaine transversus abdominis plane block when compared to simple bupivacaine and placebo for open abdominal wall reconstruction.,"[{'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Fafaj', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Krpata', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Clayton C', 'Initials': 'CC', 'LastName': 'Petro', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Ajita S', 'Initials': 'AS', 'LastName': 'Prabhu', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Rosenblatt', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Tastaldi', 'Affiliation': 'Department of General Surgery, University of Texas Medical Branch, 3100 University Boulevard, Galveston, TX 77555.'}, {'ForeName': 'Hemasat', 'Initials': 'H', 'LastName': 'Alkhatib', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tu', 'Affiliation': 'Department of Quantitative Health Sciences, Lerner Research Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Zolin', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Jonah D', 'Initials': 'JD', 'LastName': 'Thomas', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Adele M', 'Initials': 'AM', 'LastName': 'Costanzo', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Rosen', 'Affiliation': 'Cleveland Clinic Center for Abdominal Core Health, Department of General Surgery, Digestive Disease and Surgery Institute, The Cleveland Clinic Foundation, 9500 Euclid Avenue, A-100, Cleveland, OH 44195.'}]",Annals of surgery,['10.1097/SLA.0000000000004424']
2509,33273349,External Validity of the Multicenter Randomized PREOPANC Trial on Neoadjuvant Chemoradiotherapy in Pancreatic Cancer: Outcome of Eligible But Non-Randomized Patients.,"OBJECTIVES
To investigate the accrual proportion and patients' reasons for not participating in the PREOPANC trial on neoadjuvant chemoradiotherapy vs. immediate surgery in resectable and borderline resectable pancreatic cancer, and to compare these patients' outcomes with those of patients who had been randomized in the trial.
SUMMARY OF BACKGROUND DATA
The external validity of multicenter randomized trials in cancer treatment has been criticized for suboptimal non-representative inclusion. In trials, it is unclear how outcomes compare between randomized and non-randomized patients.
METHODS
At eight of 16 participant centers, this multicenter observational study identified validation patients, who had been eligible but not randomized during recruitment for the PREOPANC trial. We assessed the accrual proportion, investigated their most common reasons for not participating in the trial, and compared resection rates, radical (R0) resection rates and overall survival (OS) between the validation patients and PREOPANC patients, who had been randomized in the trial to immediate surgery.
RESULTS
In total, 455 patients had been eligible during the recruitment period, 151 of whom (33%) had been randomized. Fifty-five percent of the 304 validation patients had refused to participate. Median OS in the validation group was 15.2 months, against 15.5 months in the PREOPANC group (p = 1.00). The respective resection rates (76% vs. 73%) and R0 resection rates (51% vs. 46%) did not differ between the groups.
CONCLUSIONS
The PREOPANC trial included a reasonable percentage of 33% of eligible patients. In terms of the outcomes survival, resection rate, and R0 resection rate, this appeared to be a representative group.",2020,"The respective resection rates (76% vs. 73%) and R0 resection rates (51% vs. 46%) did not differ between the groups.
","['Fifty-five percent of the 304 validation patients had refused to participate', '455 patients had been eligible during the recruitment period, 151 of whom (33%) had been randomized', 'Pancreatic Cancer', 'At eight of 16 participant centers, this multicenter observational study identified validation patients, who had been eligible but not randomized during recruitment for the PREOPANC trial', ""patients' outcomes with those of patients who had been randomized in the trial""]","['Neoadjuvant Chemoradiotherapy', 'neoadjuvant chemoradiotherapy vs. immediate surgery']","['outcomes survival, resection rate, and R0 resection rate', 'R0 resection rates', 'Median OS', 'respective resection rates', 'resection rates, radical (R0) resection rates and overall survival (OS']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0302912', 'cui_str': 'Radical'}]",455.0,0.219426,"The respective resection rates (76% vs. 73%) and R0 resection rates (51% vs. 46%) did not differ between the groups.
","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Versteijne', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Suker', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Jesse V', 'Initials': 'JV', 'LastName': 'Groen', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Besselink', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Bert A', 'Initials': 'BA', 'LastName': 'Bonsing', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Koop', 'Initials': 'K', 'LastName': 'Bosscha', 'Affiliation': 'Department of Surgery, Jeroen Bosch Hospital, Den Bosch, the Netherlands.'}, {'ForeName': 'Olivier R', 'Initials': 'OR', 'LastName': 'Busch', 'Affiliation': 'Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Ignace H J T', 'Initials': 'IHJT', 'LastName': 'de Hingh', 'Affiliation': 'Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands.'}, {'ForeName': 'Koert P', 'Initials': 'KP', 'LastName': 'De Jong', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'I Quintus', 'Initials': 'IQ', 'LastName': 'Molenaar', 'Affiliation': 'Department of Surgery, RAKU, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Hjalmar C', 'Initials': 'HC', 'LastName': 'van Santvoort', 'Affiliation': 'Department of Surgery, RAKU, St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Casper H', 'Initials': 'CH', 'LastName': 'Van Eijck', 'Affiliation': 'Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'van Tienhoven', 'Affiliation': 'Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004364']
2510,33273348,"Response to Comment on ""Non-operative Treatment Versus Appendectomy for Acute Nonperforated Appendicitis in Children: Five-year follow up of a Randomized Controlled Pilot Trial"".",,2020,,['Acute Nonperforated Appendicitis in Children'],['Non-operative Treatment Versus Appendectomy'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}]",[],,0.0442328,,"[{'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Patkova', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet Stockholm, Sweden Department of Women's and Children's Health, Karolinska Institutet Stockholm, Sweden Department of Pediatric Surgery, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health Karolinska Institutet, Stockholm, Sweden Surgery Unit, UCL Institute of Child Health, London, United Kingdom; Department of Pediatric Surgery, Great Ormond Street Hospital, London, United Kingdom Department of Women's and Children's Health, Karolinska Institutet Stockholm, Sweden Department of Pediatric Surgery, Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Svenningsson', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Almström', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': ''}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Wester', 'Affiliation': ''}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Svensson', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004399']
2511,33273328,Safety and efficacy of allogeneic natural killer cell immunotherapy on human immunodeficiency virus type 1 immunological non-responders: a brief report.,"BACKGROUND
Allogeneic natural killer (NK) cell immunotherapy is recognized as a promising anti-tumor strategy, but whether it plays a role in poor CD4 recovery among human immunodeficiency virus type 1 (HIV-1) infected patients is unknown. This study aimed to investigate the safety and effectiveness of allogeneic NK cells immunotherapy on HIV-1 immunological non-responders (INRs) receiving antiretroviral therapy (ART).
METHODS
From February to April 2018, a prospective, randomized, controlled, open-label clinical trial, which enrolled 20 HIV-1 INRs following specific inclusion criteria, was conducted at Nankai University Second People's Hospital. Participants were randomly allocated (simple randomization 1:1) to either the combined treatment (NK + ART) group (n = 10) or the control (ART) group (n = 10). The allogenic highly activated NK cells from killer cell immunoglobulin-like receptor (KIR)/human leukocyte antigen (HLA)-Cw mismatched healthy donor were prepared (10 cells in each injection) and intravenously infused to each recruited patient of NK+ART group in three courses. Key immune parameters (CD4 count, CD8 count, CD4/CD8 ratio), laboratory tests (count of blood cells, biochemistry panel) and symptoms at baseline and at month 1, 3, 6, 9, 12, and 24 were measured/collected to analyze the safety and efficacy of the therapy. Comparisons were between the seven time-points of both groups using repeated measurement analysis of variance (ANOVA) test. Generalized estimating equations (GEE) model was performed to evaluate the overall effect of the NK+ART group vs. the ART group.
RESULTS
From baseline to 24 months, we noted a mean CD4 count augmentation (139 to 243 cells/μL) in the NK + ART group and (144 to 176 cells/μL) in the ART group (difference, 67; 95% CI, 10 to 124; P = 0.024). Our estimations revealed that NK+ART group could improve CD4 level (β = 54.59, P = 0.006) and CD8 level (β = 322.47, P = 0.010) on average among the six measurements compared with the ART group. Only two (2/10, 20%) participants in the NK+ART group developed a transient mild fever after the first course.
CONCLUSIONS
This preliminary study informs that HIV-1 INRs, allogenic NK cells immunotherapy is safe and could significantly improve CD4 recovery but not CD4/CD8 ratio. The practical effects, however, need long-term follow-up observations. Further study on the potential underlying mechanism is warranted. REGISTRATION INFO:: www.chictr.org.cn/showproj.aspx?proj=34912 (No. ChiCTR1900020634).",2020,"Our estimations revealed that NK+ART group could improve CD4 level (β = 54.59, P = 0.006) and CD8 level (β = 322.47, P = 0.010) on average among the six measurements compared with the ART group.","['human immunodeficiency virus type 1 immunological non-responders', ""enrolled 20 HIV-1 INRs following specific inclusion criteria, was conducted at Nankai University Second People's Hospital"", 'From February to April 2018', 'HIV-1 immunological non-responders (INRs) receiving antiretroviral therapy (ART']","['NK+ART', 'allogeneic NK cells immunotherapy', 'allogeneic natural killer cell immunotherapy', 'combined treatment (NK + ART', 'control (ART']","['mean CD4 count augmentation', 'safety and efficacy', 'CD4 level', 'Key immune parameters (CD4 count, CD8 count, CD4/CD8 ratio), laboratory tests (count of blood cells, biochemistry panel) and symptoms', 'transient mild fever', 'CD4 recovery', 'Safety and efficacy', 'CD8 level']","[{'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0205470', 'cui_str': 'Immunologic'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0022688', 'cui_str': 'NK-cell'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0005773', 'cui_str': 'Blood cell'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0239574', 'cui_str': 'Low grade pyrexia'}]",,0.0913645,"Our estimations revealed that NK+ART group could improve CD4 level (β = 54.59, P = 0.006) and CD8 level (β = 322.47, P = 0.010) on average among the six measurements compared with the ART group.","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Xia', 'Affiliation': ""Department of Infectious Diseases, Nankai University Second People's Hospital, Tianjin 300192, China.""}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Public Health Clinical Center of Chengdu, Chengdu, Sichuan 610066, China.'}, {'ForeName': 'Hua-Li', 'Initials': 'HL', 'LastName': 'Sun', 'Affiliation': 'Department of Infectious Diseases, The Affiliated Hospital of Qingdao University, Qingdao, Shandong 266000, China.'}, {'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Gao', 'Affiliation': ""Department of Infectious Diseases, Nankai University Second People's Hospital, Tianjin 300192, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Tianjin Institute of Hepatology, Nankai University Second People's Hospital, Tianjin 300192, China.""}, {'ForeName': 'Silvere D', 'Initials': 'SD', 'LastName': 'Zaongo', 'Affiliation': ""Department of Infectious Diseases, Nankai University Second People's Hospital, Tianjin 300192, China.""}, {'ForeName': 'Rong-Nan', 'Initials': 'RN', 'LastName': 'Zeng', 'Affiliation': ""Tianjin Institute of Hepatology, Nankai University Second People's Hospital, Tianjin 300192, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Ming-Jie', 'Initials': 'MJ', 'LastName': 'Zhang', 'Affiliation': 'HANK Bioengineering Co., Ltd., Shenzhen, Guangdong 518000, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Ma', 'Affiliation': ""Department of Infectious Diseases, Nankai University Second People's Hospital, Tianjin 300192, China.""}]",Chinese medical journal,['10.1097/CM9.0000000000001189']
2512,33273302,Phototherapy Improves Muscle Recovery and Does Not Impair Repeated Bout Effect in Plyometric Exercise.,"Padoin, S, Zeffa, AC, Molina Corrêa, JC, de Angelis, TR, Moreira, TB, Barazetti, LK, and de Paula Ramos, S. Phototherapy improves muscle recovery and does not impair repeated bout effect in plyometric exercise. J Strength Cond Res XX(X): 000-000, 2020-The effects of photobiomodulation with red (630 nm) and near-infrared (940 nm) light wavelengths were investigated on the inhibition of exercise-induced muscle damage (EIMD) and adaptation to the repeated bout effect (RBE). Twenty-eight healthy men were randomized to receive light-emitting diode therapy (LEDT) at 630 nm (4.6 J·cm, 97 J energy), LEDT at 940 nm (4.6 J·cm, 114 J), or placebo. After LEDT or placebo treatment, subjects performed 100 drop-jumps (5 sets of 20 repetitions). Creatine kinase, delayed-onset muscle soreness (DOMS), countermovement jump (CMJ), and squat jump (SJ) were assessed before, immediately after, and 24, 48, and 72 hours after the bout. After 14 days, the subjects were submitted to the same plyometric exercise, without LEDT, and were evaluated again. Creatine kinase levels increased significantly 72 hours after the first bout in the placebo group in relation to the LEDT 940-nm group (P < 0.01). The LEDT 630-nm group showed a significant increase in SJ at 24 hours (P < 0.05), whereas, at 48 hours, the LEDT 940 nm showed a significant increase compared with the placebo group (P < 0.05). The 2-way analysis of variance revealed an effect for treatment in the SJ (F = 7.12; P = 0.001). No differences were found between groups for DOMS and CMJ after the first bout. After the second bout of exercise, there was no effect of treatment. The results suggest that treatment with LEDT 630 nm and LEDT 940 nm before eccentric exercise attenuates EIMD without impairing RBE.",2020,"The LEDT 630-nm group showed a significant increase in SJ at 24 hours (P < 0.05), whereas, at 48 hours, the LEDT 940 nm showed a significant increase compared with the placebo group (P < 0.05).",['Twenty-eight healthy men'],"['same plyometric exercise, without LEDT', 'placebo', 'J Strength Cond Res XX(X', 'photobiomodulation with red (630 nm) and near-infrared (940 nm) light wavelengths', 'Phototherapy', 'light-emitting diode therapy (LEDT', 'LEDT or placebo']","['Creatine kinase levels', 'DOMS and CMJ', 'Creatine kinase, delayed-onset muscle soreness (DOMS), countermovement jump (CMJ), and squat jump (SJ', 'SJ', 'Padoin, S, Zeffa, AC, Molina Corrêa, JC, de Angelis, TR, Moreira, TB, Barazetti, LK', 'inhibition of exercise-induced muscle damage (EIMD) and adaptation to the repeated bout effect (RBE']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0449819', 'cui_str': 'Wavelength'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0750863', 'cui_str': 'Finding of creatine kinase level'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",28.0,0.137605,"The LEDT 630-nm group showed a significant increase in SJ at 24 hours (P < 0.05), whereas, at 48 hours, the LEDT 940 nm showed a significant increase compared with the placebo group (P < 0.05).","[{'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Padoin', 'Affiliation': 'Physical Education UEL/UEM, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Aline C', 'Initials': 'AC', 'LastName': 'Zeffa', 'Affiliation': 'Health Sciences, Veterinary Hospital of State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Molina Corrêa', 'Affiliation': 'Physical Education UEL/UEM, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Tarlyson R', 'Initials': 'TR', 'LastName': 'de Angelis', 'Affiliation': 'Center of Physical Education and Sports, State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Thuany B', 'Initials': 'TB', 'LastName': 'Moreira', 'Affiliation': 'Health Sciences, Veterinary Hospital of State University of Londrina, Londrina, Brazil.'}, {'ForeName': 'Lilian K', 'Initials': 'LK', 'LastName': 'Barazetti', 'Affiliation': 'Physical Education, Parana State University, Marechal Cândido Rondon, Brazil.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'de Paula Ramos', 'Affiliation': 'Study Group of Tissue Regeneration, Adaptation and Repair, Center of Biological Sciences, State University of Londrina, Londrina, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003895']
2513,33273292,The Cost of Implementing and Sustaining the COMprehensive Post-Acute Stroke Services Model.,"BACKGROUND
The COMprehensive Post-Acute Stroke Services (COMPASS) model, a transitional care intervention for stroke patients discharged home, was tested against status quo postacute stroke care in a cluster-randomized trial in 40 hospitals in North Carolina. This study examined the hospital-level costs associated with implementing and sustaining COMPASS.
METHODS
Using an activity-based costing survey, we estimated hospital-level resource costs spent on COMPASS-related activities during approximately 1 year. We identified hospitals that were actively engaged in COMPASS during the year before the survey and collected resource cost estimates from 22 hospitals. We used median wage data from the Bureau of Labor Statistics and COMPASS enrollment data to estimate the hospital-level costs per COMPASS enrollee.
RESULTS
Between November 2017 and March 2019, 1582 patients received the COMPASS intervention across the 22 hospitals included in this analysis. Average annual hospital-level COMPASS costs were $2861 per patient (25th percentile: $735; 75th percentile: $3,475). Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016). About half (N=10) of hospitals reported postacute clinic visits as their highest-cost activity, while a third (N=7) reported case ascertainment (ie, identifying eligible patients) as their highest-cost activity.
CONCLUSIONS
We found that the costs of implementing COMPASS varied across hospitals. On average, hospitals with higher stroke volume and higher enrollment reported lower costs per patient. Based on average costs of COMPASS and readmissions for stroke patients, COMPASS could lower net costs if the model is able to prevent about 6 readmissions per year.",2020,Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016).,"['Between November 2017 and March 2019', 'stroke patients discharged home, was tested against status quo postacute stroke care in a cluster-randomized trial in 40 hospitals in North Carolina', '1582 patients received the', 'hospitals that were actively engaged in COMPASS during the year before the survey and collected resource cost estimates from 22 hospitals']",['COMPASS intervention'],"['stroke patient volume', 'Average annual hospital-level COMPASS costs', 'postacute clinic visits']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",,0.129731,Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016).,"[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Bayliss', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston Salem.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Halladay', 'Affiliation': 'Department of Family Medicine, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Family Medicine, UNC School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'Department of Physical Therapy, University of Pittsburgh, Bridgeside Point 1, Pittsburgh, PA.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kucharska-Newton', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Justin G', 'Initials': 'JG', 'LastName': 'Trogdon', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.'}]",Medical care,['10.1097/MLR.0000000000001462']
2514,33273290,Evaluation of an Osteoporosis Outreach Program for Men With a Fragility Fracture and Their Physicians.,"BACKGROUND
Many health plans have outreach programs aimed at appropriately screening, evaluating, and treating women experiencing fragility fractures; however, few programs exist for men.
OBJECTIVE
The objective of this study was to develop, implement, and evaluate an osteoporosis outreach program for men with a recent fragility fracture and their physicians.
RESEARCH DESIGN AND SUBJECTS
A total of 10,934 male patients enrolled in a Medicare Advantage with Prescription Drug Plan with a recent fragility fracture were randomized to a program or control group. Patients and their physicians received letters followed by phone calls on osteoporosis and the importance of screening and treatment. The evaluation compared bone mineral density (BMD) test utilization and osteoporosis medication treatment (OPT) among patients who received the outreach versus no outreach at 12 months. The effect of the program was estimated through univariate and multivariable logistic regressions.
RESULTS
The program had a significant impact on BMD evaluation and OPT initiation. At 12 months, 10.7% of participants and 4.9% of nonparticipants received a BMD evaluation. The odds ratio (OR) (95% confidence interval) was 2.31 (1.94, 2.76), and the number needed to outreach to receive a BMD test was 18. OPT was initiated in 4.0% of participants and 2.5% of nonparticipants. The OR (95% confidence interval) of receiving OPT was 1.60 (1.24, 2.07), and the number needed to outreach was 69. Adjusted ORs were similar in magnitude and significance.
CONCLUSION
The program was highly effective by more than doubling the rate of BMD evaluation; however, more intensive interventions may yield an even higher screening rate.",2020,"The OR (95% confidence interval) of receiving OPT was 1.60 (1.24, 2.07), and the number needed to outreach was 69.","['patients who received the outreach versus no outreach at 12 months', 'women experiencing fragility fractures', 'Men With a Fragility Fracture and Their Physicians', 'men with a recent fragility fracture and their physicians', '10,934 male patients enrolled in a Medicare Advantage with Prescription Drug Plan with a recent fragility fracture']","['Osteoporosis Outreach Program', 'osteoporosis outreach program']","['odds ratio (OR', 'bone mineral density (BMD) test utilization and osteoporosis medication treatment (OPT', 'BMD evaluation and OPT initiation', 'OPT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2713369', 'cui_str': 'Medicare advantage coverage'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",10934.0,0.0454504,"The OR (95% confidence interval) of receiving OPT was 1.60 (1.24, 2.07), and the number needed to outreach was 69.","[{'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Pasquale', 'Affiliation': 'Humana Healthcare Research Inc., Louisville, KY.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Sheer', 'Affiliation': 'Humana Healthcare Research Inc., Louisville, KY.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Yehoshua', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'McFadden', 'Affiliation': 'Humana Inc., Louisville, KY.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Caloyeras', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA.'}]",Medical care,['10.1097/MLR.0000000000001459']
2515,33273276,Deep Cervical Plexus Block for Neck and Shoulder Pain Due to Myofascial Pain: A Randomized Clinical Trial.,"OBJECTIVES
Myofascial pain is one of the most common causes of regional pain yet with no definitive treatment modality. This randomized clinical trial was conducted to assess the efficacy of deep cervical plexus block versus placebo injection (sham block) for the treatment of myofascial neck and shoulder pain in terms of analgesic consumption and pain during a follow up period of two weeks after performing the block.
METHODS
Patients were randomly divided into two groups. Group I (Block) received deep cervical plexus block and group II (Placebo) received normal saline. A total of 66 patients were included in the study, 34 patients in the block group and 32 patients in the placebo group.
RESULTS
Two weeks after the intervention, average pain duration was significantly lower in the block group (1.38±1.39 vs. 5.25±1.72) for the block and placebo groups respectively (P-value<0.0001). Pain intensity was significantly less in the block group such that 2.9% of patients in the block group had severe pain compared to 53.1% of patients in the placebo group (P-value<0.0001). Two weeks after receiving the block, the mean opioid consumption calculated as tramadol equivalent was 21.1±44.2▒mg compared to 166.1±118.8▒mg for the block and placebo groups respectively. Multivariate analysis revealed that patients with a longer history of pain had a higher pain score after two weeks. The possibility of recovery is affected by pain duration since patients with chronic history of pain were least affected by the block.
DISCUSSION
This technique could be an alternative to pharmacological and non-pharmacological treatments for myofascial pain.",2020,", average pain duration was significantly lower in the block group (1.38±1.39 vs. 5.25±1.72) for the block and placebo groups respectively (P-value<0.0001).","['66 patients were included in the study, 34 patients in the block group and 32 patients in the placebo group', 'Neck and Shoulder Pain Due to Myofascial Pain', 'Patients']","['deep cervical plexus block versus placebo injection (sham block', 'deep cervical plexus block and group II (Placebo) received normal saline', 'Deep Cervical Plexus Block', 'placebo']","['pain score', 'analgesic consumption and pain', 'average pain duration', 'mean opioid consumption calculated', 'severe pain', 'myofascial neck and shoulder pain', 'Pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}]","[{'cui': 'C0394690', 'cui_str': 'Deep cervical plexus block'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",66.0,0.315058,", average pain duration was significantly lower in the block group (1.38±1.39 vs. 5.25±1.72) for the block and placebo groups respectively (P-value<0.0001).","[{'ForeName': 'Ahmad Salah', 'Initials': 'AS', 'LastName': 'Naja', 'Affiliation': 'Orthopedic division, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Madi', 'Affiliation': 'Orthopedic division, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Yehya', 'Initials': 'Y', 'LastName': 'Tfayli', 'Affiliation': 'Orthopedic division, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Ziade', 'Affiliation': 'Faculty of Public Health, Lebanese University, Beirut, Lebanon.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Haber', 'Affiliation': 'Orthopedic division, Mount Lebanon Hospital, Lebanon.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Kanawati', 'Affiliation': 'Anesthesia and Pain Management Department, Makassed General Hospital, Beirut, Lebanon.'}, {'ForeName': 'Zoher', 'Initials': 'Z', 'LastName': 'Naja', 'Affiliation': 'Anesthesia and Pain Management Department, Makassed General Hospital, Beirut, Lebanon.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000904']
2516,33273275,What Mediates Treatment Effects in a Pre-surgery Physiotherapy Treatment in Surgical Candidates with Degenerative Lumbar Spine Disorders? A Mediation and Conditional Process Analysis of the PREPARE Randomized Controlled Trial.,"OBJECTIVES
Treatment guidelines recommend targeting both physical and psychological factors in interventions for degenerative lumbar spine disorders. Studying treatment mechanisms gives information on key factors explaining outcome improvement which can refine treatments for future research. This study explores treatment mediators in a physiotherapy treatment on disability, pain intensity and health related quality of life (HRQoL) in surgical candidates with degenerative lumbar spine disorders compared to waiting-list controls. An additional aim was to evaluate patients´ expectation as a moderator of treatment outcome.
METHODS
Data collected from 197 patients in a single blinded randomized controlled trial comparing 9 weeks of multifaceted physiotherapy to waiting-list were used in this conditional process analysis. Analysis was carried out on group differences for change in Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS) back pain, EuroQol-5D (EQ-5D) and EQ-VAS. The putative moderation role of expectations and mediation role of change in physical variables and psychosocial variables were tested.
RESULTS
Change in self-efficacy mediated improvement in all outcomes. Improvement in ODI was also mediated by change in depression, VAS was mediated by change in fear avoidance beliefs and EQ-VAS was mediated by change in activity level and fear avoidance beliefs. Improvements were moderated by patients´ treatment expectations.
DISCUSSION
Self-efficacy, fear avoidance beliefs, physical activity level and patients´ treatment expectations were found to be important factors explaining treatment effects. Self-efficacy was the consistent mediator for effects of the pre-surgical physiotherapy on disability, back pain intensity and HRQoL.",2020,"Self-efficacy was the consistent mediator for effects of the pre-surgical physiotherapy on disability, back pain intensity and HRQoL.","['Data collected from 197 patients', 'Surgical Candidates with Degenerative Lumbar Spine Disorders', 'degenerative lumbar spine disorders', 'surgical candidates with degenerative lumbar spine disorders']","['Pre-surgery Physiotherapy Treatment', 'multifaceted physiotherapy to waiting-list']","['Oswestry Disability Index (ODI), Pain Visual Analog Scale (VAS) back pain, EuroQol-5D (EQ-5D) and EQ-VAS', 'ODI', 'disability, pain intensity and health related quality of life (HRQoL', 'Self-efficacy, fear avoidance beliefs, physical activity level', 'Self-efficacy', 'disability, back pain intensity and HRQoL', 'activity level and fear avoidance beliefs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",197.0,0.0868016,"Self-efficacy was the consistent mediator for effects of the pre-surgical physiotherapy on disability, back pain intensity and HRQoL.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fors', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Lindbäck', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Enthoven', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Abbott', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Division of Prevention, Rehabilitation and Community Medicine, Unit of Physiotherapy, Linköping University, SE-581 83, Linköping, Sweden.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000901']
2517,33273273,Physical Activity as a Predictor of Chronic Pain Following Pediatric Spinal Surgery.,"OBJECTIVES
(1) Characterize objective physical activity patterns via actigraphy over 4 months post-spinal fusion surgery, and (2) examine associations between activity patterns at 2-weeks and chronic post-surgical pain (CPSP) status at 4-months.
METHODS
Data from 109 youth (10-18▒y) who underwent spinal fusion surgery at a children's hospital in the northwestern United States were analyzed. Youth completed questionnaires and actigraphic assessment of physical activity pre-surgery, and 2-weeks and 4-months post-surgery.
RESULTS
18% of youth developed CPSP at 4-months. Pre-surgery physical activity was similar for youth with and without CPSP. At 2-weeks post-surgery, daily activity levels were lower for youth who developed CPSP as compared to those who did not, including lower mean activity (168 vs. 212 counts/minute, P=0.01), fewer activity bouts (n=1.7 vs. 2.6, P=0.02), and shorter bout duration (27 vs. 40▒min, P=0.02). Differences in activity were maintained at 4-months such that youth with CPSP had lower mean activity (284 vs. 334 counts/min, P=0.03), as well as greater proportion time spent sedentary and lower proportion time in light activity than youth without CPSP. In adjusted models examining 2-week actigraphy as a predictor of 4-month pain status, mean activity (OR=0.99, P=0.04) and number of activity bouts (OR=0.79, P=0.02) were associated with subsequent CPSP status.
DISCUSSION
Lower activity engagement during the initial weeks following spinal fusion surgery was associated with development of CPSP, suggesting early physical activity limitations as a risk factor for CPSP in youth. Understanding recovery patterns is critical for identifying those at risk for chronic pain and implementing early interventions.",2020,"At 2-weeks post-surgery, daily activity levels were lower for youth who developed CPSP as compared to those who did not, including lower mean activity (168 vs. 212 counts/minute, P=0.01), fewer activity bouts (n=1.7 vs. 2.6, P=0.02), and shorter bout duration (27 vs. 40▒min, P=0.02).","['Pediatric Spinal Surgery', ""Data from 109 youth (10-18▒y) who underwent spinal fusion surgery at a children's hospital in the northwestern United States were analyzed""]",[],"['number of activity bouts', 'shorter bout duration', 'surgery physical activity', 'daily activity levels', 'mean activity', '4-month pain status, mean activity', 'activity bouts', 'activity', 'Chronic Pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C1301808', 'cui_str': 'State'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",,0.0506751,"At 2-weeks post-surgery, daily activity levels were lower for youth who developed CPSP as compared to those who did not, including lower mean activity (168 vs. 212 counts/minute, P=0.01), fewer activity bouts (n=1.7 vs. 2.6, P=0.02), and shorter bout duration (27 vs. 40▒min, P=0.02).","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Rabbitts', 'Affiliation': 'Department of Anesthesiology & Pain Medicine.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Holley', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Center for Clinical and Translational Research.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000903']
2518,33273258,"Electroacupuncture vs Prucalopride for Severe Chronic Constipation: A Multicenter, Randomized, Controlled, Noninferiority Trial.","INTRODUCTION
This multicenter, randomized, noninferiority trial compared electroacupuncture with prucalopride for the treatment of severe chronic constipation (SCC).
METHODS
Participants with SCC (≤ 2 mean weekly complete spontaneous bowel movements [CSBMs]) were randomly assigned to receive either 28-session electroacupuncture over 8 weeks with follow-up without treatment over 24 weeks or prucalopride (2 mg/d before breakfast) over 32 weeks. The primary outcome was the proportion of participants with ≥3 mean weekly CSBMs over weeks 3-8, based on the modified intention-to-treat population, with -10% as the noninferior margin.
RESULTS
Five hundred sixty participants were randomized, 280 in each group. Electroacupuncture was noninferior to prucalopride for the primary outcome (36.2% vs 37.8%, with a difference of -1.6% [95% confidence interval, -8% to 4.7%], P < 0.001 for noninferiority); almost the same results were found in the per-protocol population. The proportions of overall CSBM responders through weeks 1-8 were similar in the electroacupuncture and prucalopride groups (24.91% vs 25.54%, with a difference of -0.63% [95% confidence interval, -7.86% to 6.60%, P = 0.864]). Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life. Adverse events occurred in 49 (17.69%) participants in the electroacupuncture group and 123 (44.24%) in the prucalopride group. One non-treatment-related serious adverse event was recorded in the electroacupuncture group.
DISCUSSION
Electroacupuncture was noninferior to prucalopride in relieving SCC with a good safety profile. The effects of 8-week electroacupuncture could sustain for 24 weeks after treatment. Electroacupuncture is a promising noninferior alternative for SCC (see Visual Abstract, http://links.lww.com/AJG/B776).",2020,"Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life.","['Five hundred', 'Severe Chronic Constipation', 'sixty participants were randomized, 280 in each group', 'Participants with SCC (≤ 2 mean weekly complete spontaneous bowel movements [CSBMs', 'severe chronic constipation (SCC']","['Electroacupuncture vs Prucalopride', '28-session electroacupuncture', 'Electroacupuncture', 'electroacupuncture with prucalopride', 'prucalopride', 'electroacupuncture']","['proportion of participants with ≥3 mean weekly CSBMs', 'proportions of overall CSBM responders', 'Adverse events', 'serious adverse event', 'excessive straining, stool consistency, and quality of life']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0913506', 'cui_str': 'prucalopride'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",560.0,0.22851,"Except during the first 2-week treatment, no between-group differences were found in outcomes of excessive straining, stool consistency, and quality of life.","[{'ForeName': 'Baoyan', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jiani', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Shiyan', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Kehua', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Catholic Health System Internal Medicine Training Program, University at Buffalo, Buffalo, New York, USA.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Guangdong Province Hospital of Traditional Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Tongsheng', 'Initials': 'T', 'LastName': 'Su', 'Affiliation': ""Department of Acupuncture and Moxibustion, Shaanxi Province Hospital of Traditional Chinese Medicine, Xi'an, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture and Moxibustion, Jiangsu Province Hospital of Traditional Chinese Medicine, Nanjing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, The First Hospital of Hunan University of Chinese Medicine, Changsha, China.'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hengyang Hospital Affiliated to Hunan University of Chinese Medicine, Hengyang, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Wuhan Hospital of Traditional Chinese and Western Medicine, Wuhan, China.'}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Zhongyu', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Hujie', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Xi'an TCM Brain Disease Hospital, Xi'an, China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.'}, {'ForeName': 'Liʼan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Hiser Medical Group, Qingdao, China.'}, {'ForeName': 'Linpeng', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Lv', 'Affiliation': 'Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiaofang', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'College of Acupuncture and Orthopedics, Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yuanjie', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zongshi', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture and Moxibustion, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}]",The American journal of gastroenterology,['10.14309/ajg.0000000000001050']
2519,33273255,Improvements in Muscle Strength Are Associated With Improvements in Walking Capacity in Young Children With Cerebral Palsy: A Secondary Analysis.,"PURPOSE
To evaluate whether changes in lower-limb muscle strength explain changes in walking capacity during 14-week periods of usual care, power training and follow-up for children with spastic cerebral palsy.
METHODS
Secondary analysis of a previously conducted double-baseline controlled trial of 22 children with spastic cerebral palsy. Generalized estimating equations were used to evaluate the relationships between within-subject changes in isometric muscle strength and walking capacity over 3 periods.
RESULTS
Changes in hip abductor strength were associated with changes in the Muscle Power Sprint Test, changes in gastrocnemius and hip abductor strength were associated with changes in the Shuttle Run Test, and changes in gastrocnemius strength were associated with changes in the 1-minute walk test. All associations supported better walking capacity with increased strength.
CONCLUSION
Walking capacity, especially sprint capacity, can be improved by increasing strength by functional power training in this population.",2020,"RESULTS
Changes in hip abductor strength were associated with changes in the Muscle Power Sprint Test, changes in gastrocnemius and hip abductor strength were associated with changes in the Shuttle Run Test, and changes in gastrocnemius strength were associated with changes in the 1-minute walk test.","['22 children with spastic cerebral palsy', 'children with spastic cerebral palsy', 'Young Children With Cerebral Palsy']","['usual care, power training and follow-up']","['Shuttle Run Test, and changes in gastrocnemius strength', 'walking capacity with increased strength', 'hip abductor strength', 'Walking Capacity', 'Muscle Power Sprint Test, changes in gastrocnemius and hip abductor strength', 'isometric muscle strength and walking capacity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",22.0,0.0189941,"RESULTS
Changes in hip abductor strength were associated with changes in the Muscle Power Sprint Test, changes in gastrocnemius and hip abductor strength were associated with changes in the Shuttle Run Test, and changes in gastrocnemius strength were associated with changes in the 1-minute walk test.","[{'ForeName': 'Liesbeth F', 'Initials': 'LF', 'LastName': 'van Vulpen', 'Affiliation': 'Amsterdam Rehabilitation Research Center/Reade (Drs van Vulpen and de Groot), Amsterdam, the Netherlands; Centre for Human Movement Sciences, University Medical Center Groningen, University of Groningen (Dr de Groot), Groningen, the Netherlands; Department of Rehabilitation Medicine, School for Public Health and Primary Care (CAPHRI) (Dr Rameckers), Maastricht University, Maastricht, the Netherlands, and Rehabilitation Science, University of Hasselt (Dr Rameckers), Hasselt, Belgium, and Adelante Center of Expertise in Rehabilitation and Audiology (Dr Rameckers), Valkenburg and Hoensbroek, the Netherlands, and University for Professionals for Pediatric Physical Therapy, AVANSplus (Dr Rameckers), Breda, the Netherlands; Amsterdam Movement Sciences, Department of Rehabilitation Medicine, Amsterdam UMC, Vrije Universiteit Amsterdam (Drs Becher and Dallmeijer), Amsterdam, the Netherlands.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'de Groot', 'Affiliation': ''}, {'ForeName': 'Eugene A A', 'Initials': 'EAA', 'LastName': 'Rameckers', 'Affiliation': ''}, {'ForeName': 'Jules G', 'Initials': 'JG', 'LastName': 'Becher', 'Affiliation': ''}, {'ForeName': 'Annet J', 'Initials': 'AJ', 'LastName': 'Dallmeijer', 'Affiliation': ''}]",Pediatric physical therapy : the official publication of the Section on Pediatrics of the American Physical Therapy Association,['10.1097/PEP.0000000000000764']
2520,33273210,Impact of Antiretroviral Therapy on Maternal Health after Cessation of Breastfeeding.,"IMPAACT PROMISE 1077BF/FF was a sequentially randomized study of pregnant and postpartum women living with HIV to investigate the efficacy and safety of antiretroviral therapy (ART). This Maternal Health Component investigated efficacy for the risk of developing AIDS or death; and safety among women randomized to continue ART (CTART: N=289) or discontinue ART (DCART: N=268) after cessation of breastfeeding or after confirmation of infant infection. No AIDS defining illnesses were reported during follow-up in either arm. Adverse events of grade 3 or higher were more frequent in the CTART arm (Hazard Ratio = 1.78, 95% CI (1.05, 3.02), p-value=0.03). The difference in adverse events in the two groups was mostly driven by moderate weight loss for women on the CTART arm.",2020,"Adverse events of grade 3 or higher were more frequent in the CTART arm (Hazard Ratio = 1.78, 95% CI (1.05, 3.02), p-value=0.03).","['Maternal Health after Cessation of Breastfeeding', 'pregnant and postpartum women living with HIV']","['antiretroviral therapy (ART', 'discontinue ART (DCART', 'IMPAACT', 'Antiretroviral Therapy']","['Adverse events', 'moderate weight loss', 'adverse events']","[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.120527,"Adverse events of grade 3 or higher were more frequent in the CTART arm (Hazard Ratio = 1.78, 95% CI (1.05, 3.02), p-value=0.03).","[{'ForeName': 'Sean S', 'Initials': 'SS', 'LastName': 'Brummel', 'Affiliation': 'The Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston.'}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.'}, {'ForeName': 'Konstantia Nadia', 'Initials': 'KN', 'LastName': 'Angelidou', 'Affiliation': 'The Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston.'}, {'ForeName': 'Friday', 'Initials': 'F', 'LastName': 'Saidi', 'Affiliation': 'University of North Carolina (UNC) Project - Malawi, Kamuzu Central Hospital, Malawi.'}, {'ForeName': 'Patience', 'Initials': 'P', 'LastName': 'Atuhaire', 'Affiliation': 'Makerere University -John Hopkins University Research Collaboration (MUJHU CARE LTD) CRS, Kampala, Uganda.'}, {'ForeName': 'Dingase', 'Initials': 'D', 'LastName': 'Dula', 'Affiliation': 'Johns Hopkins-College of Medicine Research Project, Blantyre, Malawi.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Centre for AIDS Research in South Africa and Department of Obstetrics and Gynecology, School of Clinical Medicine, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Matubu', 'Affiliation': 'Department of Obstetrics and Gynecology, UZ-UCSF Collaborative Project, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Gift', 'Initials': 'G', 'LastName': 'Chareka', 'Affiliation': 'Department of Obstetrics and Gynecology, UZ-UCSF Collaborative Project, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Neetal', 'Initials': 'N', 'LastName': 'Nevrekar', 'Affiliation': 'Byramjee Jeejeebhoy Government Medical College and Clinical Research Site, Pune, India.'}, {'ForeName': 'Tichaona', 'Initials': 'T', 'LastName': 'Vhembo', 'Affiliation': 'University of Zimbabwe College of Health Sciences - Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Pendo', 'Initials': 'P', 'LastName': 'Mlay', 'Affiliation': 'Kilimanjaro Christian Medical University College, Kilimanjaro Christian Medical Center.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Family Health International, Durham, NC.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Basar', 'Affiliation': 'Frontier Science and Technology Research Foundation, Amherst, NY.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'National Institute for Child Health and Human Development, Washington, D.C., United States of America.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Johns Hopkins U. School of Medicine, Baltimore, MD, United States of America.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Currier', 'Affiliation': 'Division of Infectious Diseases, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002586']
2521,33263351,Insertion of four different types of supraglottic airway devices by emergency nurses. A mannequin-based simulation study.,"BACKGROUND
During medical emergencies, one of the main steps to improve patient outcomes is to achieve airway management. Orotracheal intubation is highly effective for advanced airway management, but it requires experienced health professionals. The use of a supraglottic airway device (SAD) is an acceptable alternative.
AIM
To assess which of the four considered SADs takes the shortest time and the lowest number of attempts to be correctly placed. The secondary aim was to evaluate the influence of some characteristics of the study population on time taken and number of attempts required.
METHODS
A crossover trial was conducted at the Advanced Medical Simulation Center of the University of Perugia (Italy) between June and September 2017. Eighty-three nurses were enrolled in the study. Each participant was asked to place four different SADs in a manikin: Laryngeal Tube Suction-D (LTS-D), i-gel™, Ambu® Laryngeal Mask AuraGain™ and LMA® Protector™ Cuff Pilot™.
RESULTS
The median insertion time for the different devices was: 8.0 seconds (s) for LTS-D, 6.0 s for i-gel, 5.4 s for AuraGain, 5.8 s for LMA Protector (p<0.05); the median number of insertion attempts was: 2 for LTS-D, 1 for i-gel, AuraGain and LMA Protector (p<0.05). There was no significant relationship between insertion time and attempts required and the participants' working experience, training, or knowledge of the devices.
CONCLUSION
With the exception of LTS-D, which had the worst performance, there was a high degree of homogeneity between the studied SADs in terms of time and attempts required to achieve correct placement.",2020,"There was no significant relationship between insertion time and attempts required and the participants' working experience, training, or knowledge of the devices.
","['Advanced Medical Simulation Center of the University of Perugia (Italy) between June and September 2017', 'Eighty-three nurses were enrolled in the study']","['Orotracheal intubation', 'supraglottic airway device (SAD', 'manikin: Laryngeal Tube Suction-D (LTS-D), i-gel™, Ambu® Laryngeal Mask AuraGain™ and LMA® Protector™ Cuff Pilot™']","[""insertion time and attempts required and the participants' working experience, training, or knowledge of the devices"", 'time taken and number of attempts required', 'median insertion time']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0179788', 'cui_str': 'Suction catheter'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",83.0,0.0437489,"There was no significant relationship between insertion time and attempts required and the participants' working experience, training, or knowledge of the devices.
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Liti', 'Affiliation': 'University of Perugia. litiales@gmail.com.'}, {'ForeName': 'Gian Domenico', 'Initials': 'GD', 'LastName': 'Giusti', 'Affiliation': 'Azienda Ospedaliero Universitaria di Perugia. Didactic Tutor. School of Nursing Department of Experimental Medicine University of Perugia . giandomenico.giusti@unipg.it.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Gili', 'Affiliation': 'PhD, Department of Experimental Medicine University of Perugia. alessio.gili@unipg.it.'}, {'ForeName': 'Mirella', 'Initials': 'M', 'LastName': 'Giontella', 'Affiliation': 'Azienda Ospedaliero Universitaria di Perugia. School of Nursing Department of Medicine University of Perugia . mirella.giontella@unipg.it.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""Dell'Omo"", 'Affiliation': 'University of Perugia. Dellomosara93@gmail.com.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Camerlingo', 'Affiliation': 'U.O. Ortopedia-Urologia, Azienda USL Umbria2.. camerlingo11@gmail.com.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Fronteddu', 'Affiliation': 'AUSL della Romagna. Ospedale ""Santa Maria delle Croci"", Medicina d\'Urgenza.. sandra.frontz@hotmail.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Galazzi', 'Affiliation': ""Department of Anesthesia, Intensive Care and Emergency, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy . alessandro.galazzi@policlinico.mi.it.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bambi', 'Affiliation': 'Medical and Surgical Intensive Care Unit. Azienda Ospedaliero Universitaria Careggi, Florence. stefano.bambi@unifi.it.'}]",Acta bio-medica : Atenei Parmensis,['10.23750/abm.v91i12-S.10832']
2522,33263286,"Movement Matters, and So Does Context: Lessons Learned From Multisite Implementation of the Movement Matters Activity Program for Stroke in the Comprehensive Postacute Stroke Services Study.","The purpose of this Special Communication is to discuss the rationale and design of the Movement Matters Activity Program for Stroke (MMAP) and explore implementation successes and challenges in home health and outpatient therapy practices across the stroke belt state of North Carolina. MMAP is an interventional component of the Comprehensive Postacute Stroke Services Study, a randomized multicenter pragmatic trial of stroke transitional care. MMAP was designed to maximize survivor health, recovery, and functional independence in the community and to promote evidence-based rehabilitative care. MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care. MMAP implementation strategies were aligned with the Expert Recommendations for Implementing Change project, and MMAP site champion and facilitator survey feedback were thematically organized into the Consolidated Framework for Implementation Research domains. MMAP implementation was challenging, required modification and was affected by provider- and system-level factors. Program and study participation were limited and affected by practice priorities, productivity standards, and stroke patient volume. Sites with successful implementation appeared to have empowered MMAP champions in vertically integrated systems that embraced innovation. Findings from this broad evaluation can serve as a road map for the design and implementation of other comprehensive, complex interventions that aim to bridge the currently disconnected realms of acute care, postacute care, and community resources.",2020,"MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care.",['home health and outpatient therapy practices across the stroke belt state of North Carolina'],['MMAP'],[],"[{'cui': 'C1317851', 'cui_str': 'Home health care'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",[],,0.0374604,"MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care.","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Pastva', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina. Electronic address: amy.pastva@duke.edu.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Coyle', 'Affiliation': 'University of Pittsburgh School of Health and Rehabilitation Science, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Taylor', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Jones', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston-Salem, North Carolina.'}, {'ForeName': 'Janet K', 'Initials': 'JK', 'LastName': 'Freburger', 'Affiliation': 'University of Pittsburgh School of Health and Rehabilitation Science, Pittsburgh, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.09.386']
2523,33262331,Reduced efficacy of HIV-1 integrase inhibitors in patients with drug resistance mutations in reverse transcriptase.,"Little is known about the impact of pretreatment drug resistance (PDR) on the efficacy of second generation integrase inhibitors. We sequenced pretreatment plasma specimens from the ADVANCE trial (NCT03122262). Our primary outcome was 96-week virologic success, defined as a sustained viral load <1000 copies/mL from 12 weeks onwards, <200 copies/mL from 24 weeks onwards, and <50 copies/mL after 48 weeks. Here we report how this outcome was impacted by PDR, defined by the World Health Organization (WHO) mutation list. Of 1053 trial participants, 874 (83%) have successful sequencing, including 289 (33%) randomized to EFV-based therapy and 585 (67%) randomized to DTG-based therapy. Fourteen percent (122/874) have ≥1 WHO-defined mutation, of which 98% (120/122) are NNRTI mutations. Rates of virologic suppression are lower in the total cohort among those with PDR 65% (73/112) compared to those without PDR (85% [605/713], P < 0.001), and for those on EFV-based treatment (60% [12/20] vs 86% [214/248], P = 0.002) and for those on DTG-based treatment (61/92 [66%] vs 84% [391/465] P < 0.001, P for interaction by regimen 0.49). Results are similar in multivariable models adjusted for clinical characteristics and adherence. NNRTI resistance prior to treatment is associated with long-term failure of integrase inhibitor-containing first-line regimens, and portends high rates of first-line failure in sub Saharan Africa.",2020,Little is known about the impact of pretreatment drug resistance (PDR) on the efficacy of second generation integrase inhibitors.,"['patients with drug resistance mutations in reverse transcriptase', 'Of 1053 trial participants, 874 (83%) have successful sequencing, including 289 (33%) randomized to']","['EFV-based therapy', 'DTG-based therapy']","['96-week virologic success', 'Rates of virologic suppression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0035379', 'cui_str': 'RNA-directed DNA polymerase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0162801', 'cui_str': 'Analysis, Sequence'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",,0.235215,Little is known about the impact of pretreatment drug resistance (PDR) on the efficacy of second generation integrase inhibitors.,"[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Siedner', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa. Mark.siedner@ahri.org.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Moorhouse', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College, London, UK.'}, {'ForeName': 'Tulio', 'Initials': 'T', 'LastName': 'de Oliveira', 'Affiliation': 'University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lessells', 'Affiliation': 'University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Giandhari', 'Affiliation': 'University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Kemp', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chimukangara', 'Affiliation': 'University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Godspower', 'Initials': 'G', 'LastName': 'Akpomiemie', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Celicia M', 'Initials': 'CM', 'LastName': 'Serenata', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Willem D F', 'Initials': 'WDF', 'LastName': 'Venter', 'Affiliation': 'Ezintsha, Wits Reproductive Health and HIV Institute, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ravindra K', 'Initials': 'RK', 'LastName': 'Gupta', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa. Rkg20@cam.ac.uk.'}]",Nature communications,['10.1038/s41467-020-19801-x']
2524,33262253,Transcutaneous auricular vagus nerve stimulation (taVNS) for migraine: an fMRI study.,"BACKGROUND
Dysfunction of the thalamocortical connectivity network is thought to underlie the pathophysiology of the migraine. This current study aimed to explore the thalamocortical connectivity changes during 4 weeks of continuous transcutaneous vagus nerve stimulation (taVNS) treatment on migraine patients.
METHODS
70 migraine patients were recruited and randomized in an equal ratio to receive real taVNS or sham taVNS treatments for 4 weeks. Resting-state functional MRI was collected before and after treatment. The thalamus was parceled into functional regions of interest (ROIs) on the basis of six priori-defined cortical ROIs covering the entire cortex. Seed-based functional connectivity analysis between each thalamic subregion and the whole brain was further compared across groups after treatment.
RESULTS
Of the 59 patients that finished the study, those in the taVNS group had significantly reduced number of migraine days, pain intensity and migraine attack times after 4 weeks of treatment compared with the sham taVNS. Functional connectivity analysis revealed that taVNS can increase the connectivity between the motor-related thalamus subregion and anterior cingulate cortex/medial prefrontal cortex, and decrease the connectivity between occipital cortex-related thalamus subregion and postcentral gyrus/precuneus.
CONCLUSION
Our findings suggest that taVNS can relieve the symptoms of headache as well as modulate the thalamocortical circuits in migraine patients. The results provide insights into the neural mechanism of taVNS and reveal potential therapeutic targets for migraine patients.",2020,"Functional connectivity analysis revealed that taVNS can increase the connectivity between the motor-related thalamus subregion and anterior cingulate cortex/medial prefrontal cortex, and decrease the connectivity between occipital cortex-related thalamus subregion and postcentral gyrus/precuneus.
","['migraine patients', 'migraine', '70 migraine patients']","['Transcutaneous auricular vagus nerve stimulation (taVNS', 'taVNS', 'continuous transcutaneous vagus nerve stimulation (taVNS', 'real taVNS or sham taVNS']","['Resting-state functional MRI', 'connectivity between occipital cortex-related thalamus subregion and postcentral gyrus/precuneus', 'number of migraine days, pain intensity and migraine attack times']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0152302', 'cui_str': 'Structure of postcentral gyrus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",70.0,0.02837,"Functional connectivity analysis revealed that taVNS can increase the connectivity between the motor-related thalamus subregion and anterior cingulate cortex/medial prefrontal cortex, and decrease the connectivity between occipital cortex-related thalamus subregion and postcentral gyrus/precuneus.
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Zhaoxian', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Weicui', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Sierra', 'Initials': 'S', 'LastName': 'Hodges', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China JKONG2@mgh.harvard.edu liubogzcm@163.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA JKONG2@mgh.harvard.edu liubogzcm@163.com.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-102088']
2525,33262252,Effect of tranexamic acid on intracranial haemorrhage and infarction in patients with traumatic brain injury: a pre-planned substudy in a sample of CRASH-3 trial patients.,"BACKGROUND
Early tranexamic acid (TXA) treatment reduces head injury deaths after traumatic brain injury (TBI). We used brain scans that were acquired as part of the routine clinical practice during the CRASH-3 trial (before unblinding) to examine the mechanism of action of TXA in TBI. Specifically, we explored the potential effects of TXA on intracranial haemorrhage and infarction.
METHODS
This is a prospective substudy nested within the CRASH-3 trial, a randomised placebo-controlled trial of TXA (loading dose 1 g over 10 min, then 1 g infusion over 8 hours) in patients with isolated head injury. CRASH-3 trial patients were recruited between July 2012 and January 2019. Participants in the current substudy were a subset of trial patients enrolled at 10 hospitals in the UK and 4 in Malaysia, who had at least one CT head scan performed as part of the routine clinical practice within 28 days of randomisation. The primary outcome was the volume of intraparenchymal haemorrhage (ie, contusion) measured on a CT scan done after randomisation. Secondary outcomes were progressive intracranial haemorrhage (post-randomisation CT shows >25% of volume seen on pre-randomisation CT), new intracranial haemorrhage (any haemorrhage seen on post-randomisation CT but not on pre-randomisation CT), cerebral infarction (any infarction seen on any type of brain scan done post-randomisation, excluding infarction seen pre-randomisation) and intracranial haemorrhage volume (intraparenchymal + intraventricular + subdural + epidural) in those who underwent neurosurgical haemorrhage evacuation. We planned to conduct sensitivity analyses excluding patients who were severely injured at baseline. Dichotomous outcomes were analysed using relative risks (RR) or hazard ratios (HR), and continuous outcomes using a linear mixed model.
RESULTS
1767 patients were included in this substudy. One-third of the patients had a baseline GCS (Glasgow Coma Score) of 3 (n=579) and 24% had unilateral or bilateral unreactive pupils. 46% of patients were scanned pre-randomisation and post-randomisation (n=812/1767), 19% were scanned only pre-randomisation (n=341/1767) and 35% were scanned only post-randomisation (n=614/1767). In all patients, there was no evidence that TXA prevents intraparenchymal haemorrhage expansion (estimate=1.09, 95% CI 0.81 to 1.45) or intracranial haemorrhage expansion in patients who underwent neurosurgical haemorrhage evacuation (n=363) (estimate=0.79, 95% CI 0.57 to 1.11). In patients scanned pre-randomisation and post-randomisation (n=812), there was no evidence that TXA reduces progressive haemorrhage (adjusted RR=0.91, 95% CI 0.74 to 1.13) and new haemorrhage (adjusted RR=0.85, 95% CI 0.72 to 1.01). When patients with unreactive pupils at baseline were excluded, there was evidence that TXA prevents new haemorrhage (adjusted RR=0.80, 95% CI 0.66 to 0.98). In patients scanned post-randomisation (n=1431), there was no evidence of an increase in infarction with TXA (adjusted HR=1.28, 95% CI 0.93 to 1.76). A larger proportion of patients without (vs with) a post-randomisation scan died from head injury (38% vs 19%: RR=1.97, 95% CI 1.66 to 2.34, p<0.0001).
CONCLUSION
TXA may prevent new haemorrhage in patients with reactive pupils at baseline. This is consistent with the results of the CRASH-3 trial which found that TXA reduced head injury death in patients with at least one reactive pupil at baseline. However, the large number of patients without post-randomisation scans and the possibility that the availability of scan data depends on whether a patient received TXA, challenges the validity of inferences made using routinely collected scan data. This study highlights the limitations of using routinely collected scan data to examine the effects of TBI treatments.
TRIAL REGISTRATION NUMBER
ISRCTN15088122.",2020,"In patients scanned post-randomisation (n=1431), there was no evidence of an increase in infarction with TXA (adjusted HR=1.28, 95% CI 0.93 to 1.76).","['1767 patients were included in this substudy', 'patients with traumatic brain injury', 'patients who were severely injured at baseline', 'One-third of the patients had a baseline GCS (Glasgow Coma Score) of 3 (n=579) and 24% had unilateral or bilateral unreactive pupils', 'patients with isolated head injury', 'CRASH-3 trial patients were recruited between July 2012 and January 2019', 'Participants in the current substudy were a subset of trial patients enrolled at 10 hospitals in the UK and 4 in Malaysia, who had at least one CT head scan performed as part of the routine clinical practice within 28 days of randomisation', 'head injury deaths after traumatic brain injury (TBI', 'patients with reactive pupils at baseline']","['placebo', 'TXA', 'tranexamic acid', 'tranexamic acid (TXA']","['progressive haemorrhage', 'new haemorrhage', 'progressive intracranial haemorrhage', 'volume of intraparenchymal haemorrhage (ie, contusion', 'head injury death', 'pre-randomisation CT), new intracranial haemorrhage', 'intracranial haemorrhage volume', 'relative risks (RR) or hazard ratios (HR), and continuous outcomes using a linear mixed model', 'intracranial haemorrhage expansion', 'intraparenchymal haemorrhage expansion', 'infarction with TXA', 'intracranial haemorrhage and infarction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0202691', 'cui_str': 'CT of head'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0018674', 'cui_str': 'Injury of head'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]",1767.0,0.560469,"In patients scanned post-randomisation (n=1431), there was no evidence of an increase in infarction with TXA (adjusted HR=1.28, 95% CI 0.93 to 1.76).","[{'ForeName': 'Abda', 'Initials': 'A', 'LastName': 'Mahmood', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine Faculty of Epidemiology and Population Health, London, UK Abda.Mahmood@LSHTM.ac.uk.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Needham', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine Faculty of Epidemiology and Population Health, London, UK.'}, {'ForeName': 'Haleema', 'Initials': 'H', 'LastName': 'Shakur-Still', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine Faculty of Epidemiology and Population Health, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Harris', 'Affiliation': 'Department of Emergency Medicine, Royal London Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Sabariah Faizah', 'Initials': 'SF', 'LastName': 'Jamaluddin', 'Affiliation': 'Emergency Department, Hospital Sungai Buloh, Sungai Buloh, Malaysia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Davies', 'Affiliation': 'NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Belli', 'Affiliation': 'NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Fatahul Laham', 'Initials': 'FL', 'LastName': 'Mohamed', 'Affiliation': 'Emergency Department, Hospital Sultanah Bahiyah, Alor Setar, Malaysia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Leech', 'Affiliation': 'Emergency Department, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Hamzah Mohd', 'Initials': 'HM', 'LastName': 'Lotfi', 'Affiliation': 'Emergency Department, Hospital Sultanah Nur Zahirah, Kuala Terengganu, Malaysia.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Moss', 'Affiliation': ""Clinical Research Unit, Emergency Department, Saint George's University Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lecky', 'Affiliation': 'Accident & Emergency, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hopkins', 'Affiliation': ""Emergency Department, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Darin', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Emergency Department, Penang General Hospital, Georgetown, Malaysia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Boyle', 'Affiliation': ""Emergency Department, Addenbrooke's Hospital Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wilson', 'Affiliation': ""Neurosurgeries, Emergencies & Trauma, Division of Medicine, St Mary's Hospital, Imperial College Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Darwent', 'Affiliation': 'Emergency Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Roberts', 'Affiliation': 'Clinical Trials Unit, London School of Hygiene & Tropical Medicine Faculty of Epidemiology and Population Health, London, UK.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2020-210424']
2526,33262230,Efficacy of high-intensity aerobic exercise on brain MRI measures in multiple sclerosis.,"OBJECTIVE
To determine whether 24 weeks of high-intensity progressive aerobic exercise (PAE) affects brain MRI measures in people with multiple sclerosis (MS).
METHODS
We conducted a randomized, controlled, phase 2 trial (with a crossover follow-up) including an exercise group (supervised PAE followed by self-guided physical activity) and a waitlist group (habitual lifestyle followed by supervised PAE). Mildly to severely impaired MS patients aged 18-65 years were randomized (1:1). The primary outcome was percentage brain volume change (PBVC) after 24 weeks, analyzed using the intention-to-treat principle.
RESULTS
Eighty-six participants were recruited. PBVC did not change over the intervention period (mean between-group change +0.12%, 95% CI -0.27 to 0.51, p = 0.55). In contrast, cardiorespiratory fitness (+3.5 mL O 2 /min/kg, 2.0 to 5.1, p < 0.01) and annualized relapse rate (0.00, 0.00-0.07 vs +0.45, 0.28 to 0.61, p < 0.01) improved in the exercise group.
CONCLUSION
These findings do not support a neuroprotective effect of PAE in terms of total brain atrophy in people with MS and it did not lead to a statistically significant difference in gray matter parenchymal fraction. PAE led to improvements in cardiorespiratory fitness and a lower relapse rate. While these exploratory findings cautiously support PAE as a potential adjunct disease-modifying treatment in MS, further investigations are warranted.
CLINICALTRIALS REGISTRATION
ClinicalTrials.gov identifier NCT02661555.
CLASSIFICATION OF EVIDENCE
This study provides level I evidence that 24 weeks of high-intensity PAE did not elicit disease-modifying effects in PBVC in people with MS. Exploratory analyses showed that PAE may reduce relapse rate.",2020,These findings do not support a neuroprotective effect of PAE in terms of total brain atrophy in people with MS and it did not lead to a statistically significant difference in gray matter parenchymal fraction.,"['people with multiple sclerosis (MS', 'Eighty-six participants were recruited', 'multiple sclerosis', 'Mildly to severely impaired MS patients aged 18-65 years', 'people with MS']","['exercise group (supervised PAE followed by self-guided physical activity) and a waitlist group (habitual lifestyle followed by supervised PAE', 'PAE', 'high-intensity progressive aerobic exercise (PAE', 'high-intensity aerobic exercise']","['gray matter parenchymal fraction', 'cardiorespiratory fitness', 'annualized relapse rate', 'brain MRI measures', 'PBVC', 'relapse rate', 'percentage brain volume change (PBVC', 'total brain atrophy']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0235946', 'cui_str': 'Cerebral atrophy'}]",86.0,0.213826,These findings do not support a neuroprotective effect of PAE in terms of total brain atrophy in people with MS and it did not lead to a statistically significant difference in gray matter parenchymal fraction.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Langeskov-Christensen', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark; mach@ph.au.dk.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøndahl Hvid', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mikkel Karl Emil', 'Initials': 'MKE', 'LastName': 'Nygaard', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Ringgaard', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Henrik Boye', 'Initials': 'HB', 'LastName': 'Jensen', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Helle Hvilsted', 'Initials': 'HH', 'LastName': 'Nielsen', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Petersen', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Egon', 'Initials': 'E', 'LastName': 'Stenager', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Simon Fristed', 'Initials': 'SF', 'LastName': 'Eskildsen', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'M Langeskov-Christensen, LG Hvid, U Dalgas, Section for Sport Science, Department of Public Health, Aarhus University, Aarhus, Denmark.'}]",Neurology,['10.1212/WNL.0000000000011241']
2527,33261633,Should ice application be replaced with neurocryostimulation for the treatment of acute lateral ankle sprains? A randomized clinical trial.,"STUDY DESIGN
Single-blind parallel group randomized clinical trial.
OBJECTIVES
To compare the effects of neurocryostimulation (NCS) with those of traditional ice application on functional recovery, pain, edema and ankle dorsiflexion range of motion (ROM) in individuals receiving physiotherapy treatments for acute lateral ankle sprains (LAS).
BACKGROUND
Ankle sprain is a very common injury and its management is often costly, with important short- and long-term impacts on individuals and society. As new methods of therapy using cold (cryotherapy) are emerging for the treatment of musculoskeletal conditions, little evidence exists to support their use. NCS, which provokes a rapid cooling of the skin with the liberation of pressured CO 2 , is a method believed to accelerate the resorption of edema and recovery in the case of traumatic injuries.
METHODS
Forty-one participants with acute LAS were randomly assigned either to a group that received in-clinic physiotherapy treatments and NCS (experimental NCS group, n = 20), or to a group that received the same in-clinic physiotherapy treatments and traditional ice application (comparison ice group, n = 21). Primary (Lower Extremity Functional Scale - LEFS) and secondary (visual analog scale for pain intensity at rest and during usual activities in the last 48 h, Figure of Eight measurement of edema, and weight bearing lunge for ankle dorsiflexion range of motion) outcomes were evaluated at baseline (T0), after one week (T1), two weeks (T2), four weeks (T4) and finally, after six weeks (T6). The effects of interventions were assessed using two-way ANOVA-type Nonparametric Analysis for Longitudinal Data (nparLD).
RESULTS
No significant group-time interaction or group effect was observed for all outcomes (0.995 ≥ p ≥ 0.057) following the intervention. Large time effects were however observed for all outcomes (p < 0.0001).
CONCLUSION
Results suggest that neurocryostimulation is no more effective than traditional ice application in improving functional recovery, pain, edema, and ankle dorsiflexion ROM during the first six weeks of physiotherapy treatments in individuals with acute LAS.
LEVEL OF EVIDENCE
Therapy, level 1b.
TRIAL REGISTRATION
ClinicalTrials.gov , NCT02945618 . Registered 23 October 2016 - Retrospectively registered (25 participants recruited prior to registration, 17 participants after).",2020,"CONCLUSION
Results suggest that neurocryostimulation is no more effective than traditional ice application in improving functional recovery, pain, edema, and ankle dorsiflexion ROM during the first six weeks of physiotherapy treatments in individuals with acute LAS.
","['Forty-one participants with acute LAS', 'Retrospectively registered (25 participants recruited prior to registration, 17 participants after', 'individuals with acute LAS', 'individuals receiving physiotherapy treatments for acute lateral ankle sprains (LAS', 'Registered 23 October 2016 ']","['clinic physiotherapy treatments and NCS (experimental NCS group, n\u2009=\u200920), or to a group that received the same in-clinic physiotherapy treatments and traditional ice application (comparison ice group, n\u2009=\u200921', 'cold (cryotherapy', 'traditional ice application', 'neurocryostimulation (NCS', 'NCS']","['functional recovery, pain, edema, and ankle dorsiflexion ROM', 'functional recovery, pain, edema and ankle dorsiflexion range of motion (ROM', 'Primary (Lower Extremity Functional Scale - LEFS) and secondary (visual analog scale for pain intensity at rest and during usual activities in the last 48\u2009h, Figure of Eight measurement of edema, and weight bearing lunge for ankle dorsiflexion range of motion) outcomes']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0204767', 'cui_str': 'Application of ice'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",41.0,0.104809,"CONCLUSION
Results suggest that neurocryostimulation is no more effective than traditional ice application in improving functional recovery, pain, edema, and ankle dorsiflexion ROM during the first six weeks of physiotherapy treatments in individuals with acute LAS.
","[{'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Tittley', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Luc J', 'Initials': 'LJ', 'LastName': 'Hébert', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Roy', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City, Quebec, Canada. Jean-Sebastien.Roy@fmed.ulaval.ca.'}]",Journal of foot and ankle research,['10.1186/s13047-020-00436-6']
2528,33261603,Cost-utility analysis of hearing aid device for older adults in the community: a delayed start study.,"BACKGROUND
Hearing aids (HA) is the primary medical intervention aimed to reduce hearing handicap. This study assessed the cost-effectiveness of HA for older adults who were volunteered to be screened for hearing loss in a community-based mobile hearing clinic (MHC).
METHODS
Participants with (1) at least moderate hearing loss (≥40 dB HL) in at least one ear, (2) no prior usage of HA, (3) no ear related medical complications, and (4) had a Mini-Mental State Examination score ≥ 18 were eligible for this study. Using a delayed-start study design, participants were randomized into the immediate-start (Fitted) group where HA was fitted immediately or the delayed-start (Not Fitted) group where HA fitting was delayed for three months. Cost utility analysis was used to compare the cost-effectiveness of being fitted with HA combined with short-term, aural rehabilitation with the routine care group who were not fitted with HA. Incremental cost effectiveness ration (ICER) was computed. Health Utility Index (HUI-3) was used to measure utility gain, a component required to derive the quality adjusted life years (QALY). Total costs included direct healthcare costs, direct non-healthcare costs and indirect costs (productivity loss of participant and caregiver). Demographic data was collected during the index visit to MHC. Cost and utility data were collected three months after index visit and projected to five years.
RESULTS
There were 264 participants in the Fitted group and 163 participants in the Not Fitted group. No between-group differences in age, gender, ethnicity, housing type and degree of hearing loss were observed at baseline. At 3 months, HA fitting led to a mean utility increase of 0.12 and an ICER gain of S$42,790/QALY (95% CI: S$32, 793/QALY to S$62,221/QALY). At five years, the ICER was estimated to be at S$11,964/QALY (95% CI: S$8996/QALY to S$17,080/QALY) assuming 70% of the participants continued using the HA. As fewer individuals continued using their fitted HA, the ICER increased.
CONCLUSIONS
HA fitting can be cost-effective and could improve the quality of life of hearing-impaired older individuals within a brief period of device fitting. Long term cost-effectiveness of HA fitting is dependent on its continued usage.",2020,"No between-group differences in age, gender, ethnicity, housing type and degree of hearing loss were observed at baseline.","['older adults in the community', 'Participants with (1) at least moderate hearing loss (≥40\u2009dB HL) in at least one ear, (2) no prior usage of HA, (3) no ear related medical complications, and (4) had a Mini-Mental State Examination score\u2009≥', 'older adults who were volunteered to be screened for hearing loss in a community-based mobile hearing clinic (MHC', '264 participants in the Fitted group and 163 participants in the Not Fitted group']","['hearing aid device', 'Hearing aids (HA']","['Incremental cost effectiveness ration (ICER', 'Cost and utility data', 'cost-effectiveness', 'hearing loss', 'Total costs included direct healthcare costs, direct non-healthcare costs and indirect costs (productivity loss of participant and caregiver', 'quality of life of hearing', 'ICER', 'ICER gain of S$42,790/QALY', 'cost-effectiveness of HA', 'Health Utility Index (HUI-3']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439498', 'cui_str': 'dB HL'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",264.0,0.0469368,"No between-group differences in age, gender, ethnicity, housing type and degree of hearing loss were observed at baseline.","[{'ForeName': 'Palvinder', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': 'Health Services and Outcomes Research, National Healthcare Group, 3 Fusionopolis Link #03-08 Nexus@One-north, Singapore, 138543, Singapore.'}, {'ForeName': 'Sheue Lih', 'Initials': 'SL', 'LastName': 'Chong', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Palvannan', 'Initials': 'P', 'LastName': 'Kannapiran', 'Affiliation': 'Health Services and Outcomes Research, National Healthcare Group, 3 Fusionopolis Link #03-08 Nexus@One-north, Singapore, 138543, Singapore.'}, {'ForeName': 'W-S Kelvin', 'Initials': 'WK', 'LastName': 'Teo', 'Affiliation': 'Health Services and Outcomes Research, National Healthcare Group, 3 Fusionopolis Link #03-08 Nexus@One-north, Singapore, 138543, Singapore.'}, {'ForeName': 'Charis Ng Wei', 'Initials': 'CNW', 'LastName': 'Ling', 'Affiliation': 'Health Services and Outcomes Research, National Healthcare Group, 3 Fusionopolis Link #03-08 Nexus@One-north, Singapore, 138543, Singapore.'}, {'ForeName': 'Chiang Win', 'Initials': 'CW', 'LastName': 'Weichen', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Gan', 'Initials': 'G', 'LastName': 'Ruling', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Lee Sing', 'Initials': 'LS', 'LastName': 'Yin', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Tang Ying', 'Initials': 'TY', 'LastName': 'Leng', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Soo Ying', 'Initials': 'SY', 'LastName': 'Pei', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Then Tze', 'Initials': 'TT', 'LastName': 'Kang', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Lim Zhen', 'Initials': 'LZ', 'LastName': 'Han', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Peizhen', 'Affiliation': 'Ear, Nose and Throat Head & Neck Department, National University Hospital, 5 Lower Kent Ridge Road, Singapore, 119074, Singapore.'}, {'ForeName': 'Lynne Lim Hsueh', 'Initials': 'LLH', 'LastName': 'Yee', 'Affiliation': 'Ear Nose Throat & Hearing Centre, 3 Mount Elizabeth, Singapore, 228510, Singapore.'}, {'ForeName': 'Pradeep Paul', 'Initials': 'PP', 'LastName': 'George', 'Affiliation': 'Health Services and Outcomes Research, National Healthcare Group, 3 Fusionopolis Link #03-08 Nexus@One-north, Singapore, 138543, Singapore. pradeep_paul_g_gunapal@nhg.com.sg.'}]",BMC health services research,['10.1186/s12913-020-05977-x']
2529,33261578,Animal-assisted therapy on happiness and life quality of chronic psychiatric patients living in psychiatric residential care homes: a randomized controlled study.,"BACKGROUND
Psychiatric patients who live in psychiatric residential care homes may often feel a loss of autonomy, decision making, and participation in social activities. They usually have few or no visitors and also do not have any purpose for living. Animals may increase the happiness and quality of life of psychiatric patients. This study aimed to evaluate the effects of Animal-Assisted Therapy (AAT) on happiness and quality of life of chronic psychiatric patients living in psychiatric residential care homes in Tehran, Iran.
METHODS
This randomized controlled trial was conducted with 70 males with a chronic psychiatric disorder who were living in psychiatric residential care homes in Tehran, Iran, in 2016. The patients were randomly selected and divided into animal therapy intervention group and control group. Patients in the intervention group received animal-therapy with a bird for eight weeks. Patients in the control group received no intervention. The Oxford Happiness Inventory evaluated all patients pre and post-intervention. To evaluate life quality, the Wisconsin Quality of Life Index was used. Data were statically analyzed using SPSS Ver.19.0. ANCOVA with pretest statistical control. The significance level was set as p < 0.05.
RESULTS
The mean age in both control and intervention groups were 47.12 and 45.82 years, and the mean age of illness onset for both control and intervention groups was 18.94 and 16.83 years, respectively. The result of this study showed that happiness in the intervention group had significantly increased (p < 0.001). The results also showed that the quality of life in four sub-domains increased significantly.
CONCLUSION
To bring happiness to chronic psychiatric patients living in psychiatric residential care homes is essential and may result in returning them to society and healthy life. The results of this study showed that AAT was helpful for chronic psychiatric patients living in psychiatric residential care homes and not only made them happy but also increased their quality of life.
TRIAL REGISTRATION
This was registered in Iranian Registry of Clinical Trials (IRCT) (clinical trial code: IRCT20101013004922N4. Registered 2018-08-19. Retrospectively registered, https://www.irct.ir/trial/32390.",2020,The result of this study showed that happiness in the intervention group had significantly increased (p < 0.001).,"['Psychiatric patients who live in psychiatric residential care homes', 'chronic psychiatric patients living in psychiatric residential care homes', '70 males with a chronic psychiatric disorder who were living in psychiatric residential care homes in Tehran, Iran, in 2016', 'chronic psychiatric patients living in psychiatric residential care homes in Tehran, Iran']","['Animal-Assisted Therapy (AAT', 'Animal-assisted therapy', 'AAT', 'animal therapy intervention group and control group', 'animal-therapy']","['quality of life', 'happiness and quality of life', 'happiness and life quality', 'life quality, the Wisconsin Quality of Life Index']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0870281', 'cui_str': 'Chronic mental disorder'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0150133', 'cui_str': 'Animal-assisted therapy'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}]",70.0,0.127762,The result of this study showed that happiness in the intervention group had significantly increased (p < 0.001).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebalzamani', 'Affiliation': 'Department of Management, Faculty of Health, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rezaei', 'Affiliation': 'Department of Psychiatry, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan Fattah', 'Initials': 'LF', 'LastName': 'Moghadam', 'Affiliation': 'Department of Nursing, Faculty of nursing and midwifery, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran. lfatah@iautmu.ac.ir.'}]",BMC psychiatry,['10.1186/s12888-020-02980-8']
2530,33261542,Metabolic and appetite effects of fructose and glucose in subjects with type 1 diabetes: a randomized crossover clinical trial.,"BACKGROUND
Fructose has been widely used for producing lower post-infusion glucose increase than other carbohydrates, but seems that it promotes an increase in post-infusion triglycerides.
OBJECTIVE
The present study investigated the effects of fructose and glucose in metabolic variables and appetite sensations in patients with type 1 diabetes mellitus (T1DM).
METHODS
This is a single-blind, randomized and crossover study (washout of 1-5 weeks), which has evaluated 16 adult T1DM patients, accompanied at University Hospital. After eight hours overnight fasting, were assessment of capillary blood glucose, anthropometric variables, appetite sensations and laboratory tests (glycemia, lipemia, leptin and glucagon). Subsequently, they received 200mL of solutions with water and 75g of crystal fructose or glucose. Appetite sensations and capillary blood glucose were evaluated in different post-infusion times. Blood was drawn after 180 minutes for the laboratory tests.
RESULTS
Blood glucose increased after the intake of both solutions, but the glucose induced a higher elevation. None of them increased triglycerides or glucagon. Glucagon maintenance was similar among the solutions. Furthermore, both solutions reduced leptin and increased fullness, but only fructose increased lack of interest in eating sweets.
CONCLUSIONS
Fructose induced smaller increase in postprandial blood glucose than glucose, without changes in triglycerides and glucagon. In addition, leptin levels and appetite sensations were similar to glucose. Other studies are needed in order to confirm these findings, especially in the long term, so that their use becomes really reliable.",2020,None of them increased triglycerides or glucagon.,"['patients with type 1 diabetes mellitus (T1DM', '16 adult T1DM patients, accompanied at University Hospital', 'subjects with type 1 diabetes']","['200mL of solutions with water and 75g of crystal fructose or glucose', 'fructose and glucose']","['postprandial blood glucose', 'Appetite sensations and capillary blood glucose', 'metabolic variables and appetite sensations', 'Glucagon maintenance', 'leptin levels and appetite sensations', 'triglycerides and glucagon', 'leptin and increased fullness', 'Blood glucose', 'capillary blood glucose, anthropometric variables, appetite sensations and laboratory tests (glycemia, lipemia, leptin and glucagon', 'triglycerides or glucagon']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0132254', 'cui_str': 'drebrin A'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}]",,0.0472165,None of them increased triglycerides or glucagon.,"[{'ForeName': 'Érika', 'Initials': 'É', 'LastName': 'Dos Santos Lima', 'Affiliation': 'Federal University of Rio de Janeiro, Nutrition Institute Josué de Castro, Rio de Janeiro, RJ. Brazil.'}, {'ForeName': 'Débora Lopes', 'Initials': 'DL', 'LastName': 'Souto', 'Affiliation': 'Federal University of Rio de Janeiro, Nutrition Institute Josué de Castro, Rio de Janeiro, RJ. Brazil.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Rodacki', 'Affiliation': 'Federal University of Rio de Janeiro, Medicine Institute, Rio de Janeiro, RJ. Brazil.'}, {'ForeName': 'Joana Rodrigues Dantas', 'Initials': 'JRD', 'LastName': 'Pereira', 'Affiliation': 'Federal University of Rio de Janeiro, Medicine Institute, Rio de Janeiro, RJ. Brazil.'}, {'ForeName': 'Lenita', 'Initials': 'L', 'LastName': 'Zajdenverg', 'Affiliation': 'Federal University of Rio de Janeiro, Medicine Institute, Rio de Janeiro, RJ. Brazil.'}, {'ForeName': 'Eliane Lopes', 'Initials': 'EL', 'LastName': 'Rosado', 'Affiliation': 'Federal University of Rio de Janeiro, Nutrition Institute Josué de Castro, Rio de Janeiro, RJ. Brazil.'}]",Current diabetes reviews,['10.2174/1573399816666201201092334']
2531,33260699,Effects of an Educational Program for Professional Caregivers on Behavioral Alterations in Nursing Home Residents: Pilot Study.,"This pilot study aims to analyze the effectiveness of a type of non-pharmacological intervention such as the educating and training of professional caregivers on behavioral alterations and prescription of psychotropic drugs of older adults in nursing homes. One hundred and forty-five people from two nursing homes were randomized to either treatment (educational training program for healthcare professionals) or a no-treatment group. Twenty-two professional caregivers in the experimental group received 20 h of a training program. Five data collection points were collected (pre and post, and three follow-ups, all six months apart). Intervention consisted of the behavioral alterations and psychopharmacological treatment. The analysis of variance for repeated measures showed significant differences in the time-group interaction for the educational program's effectiveness in reducing behavior alterations and psycho-pharmaceuticals' record. The results show that an improvement in the educating and training of professional caregivers can reduce behavioral alterations (F3,407 = 9.29, p < 0.001, η 2 = 0.063) and prescription of psychotropic drugs (F2,10 = 18.90, p < 0.001, η 2 = 0.117). In addition, these effects are maintained over time. Educating health professionals on ways to care for residents who present behavioral alterations may be one alternative for improving the quality of care that residents receive. Non-pharmacological interventions, besides being individualized and adapted to the needs and experiences of individuals, achieve effects that last longer at low cost. An educational program shows new alternatives to pharmacological intervention, achieving a reduction in behavioral alterations without the costs and effects that psychopharmaceuticals entail.",2020,The analysis of variance for repeated measures showed significant differences in the time-group interaction for the educational program's effectiveness in reducing behavior alterations and psycho-pharmaceuticals' record.,"['older adults in nursing homes', 'Nursing Home Residents', 'One hundred and forty-five people from two nursing homes']","['Educational Program', 'treatment (educational training program for healthcare professionals) or a no-treatment group', 'psychopharmacological treatment']","['behavioral alterations', 'prescription of psychotropic drugs', 'Behavioral Alterations']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}]",145.0,0.023454,The analysis of variance for repeated measures showed significant differences in the time-group interaction for the educational program's effectiveness in reducing behavior alterations and psycho-pharmaceuticals' record.,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Pinazo-Clapés', 'Affiliation': 'Faculty of Psychology, European University, 46010 Valencia, Spain.'}, {'ForeName': 'Sacramento', 'Initials': 'S', 'LastName': 'Pinazo-Hernandis', 'Affiliation': 'Department of Social Psychology, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Sales', 'Affiliation': 'Department of Developmental Psychology, Faculty of Psychology, University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17238845']
2532,33260697,"An mHealth Workplace-Based ""Sit Less, Move More"" Program: Impact on Employees' Sedentary and Physical Activity Patterns at Work and Away from Work.","BACKGROUND
Most workplace interventions that aim to reduce sedentary behaviour have 38 focused on employees' sedentary patterns at-work but less have focused on understanding the 39 impact beyond working time. The aim of this study was to evaluate the impact of a 13-week m-40 health workplace-based 'sit less, move more' intervention (Walk@WorkApp; W@W-App) on 41 physical activity (PA) and sitting in desk-based employees at-work and away from work.
METHODS
Participants ( n = 141) were assigned by hospital to an intervention group (IG; used the W@W-App; n = 90) or an active comparison group (A-CG; monitored occupational activity; n = 51). The W@W-App, installed on the participants´ own smartphones, provided real-time feedback for occupational sitting, standing, and stepping, and gave access to automated strategies to sit less and move more at work. Changes between groups were assessed for total sitting time, sedentary bouts and breaks, and light and moderate-to-vigorous PA (activPAL3TM; min/day) between the baseline and after program completion.
RESULTS
Compared to the A-CG, employees that used the W@W-App program increased their number of daily breaks and the time spent on short sedentary bouts (<20 min, p = 0.047) during weekends. Changes in shortest sedentary bouts (5-10 min) during weekends were also statistically significant ( p < 0.05). No changes in workday PA or sitting were observed.
CONCLUSION
Desk-based employees seemed to transfer the W@W-App program knowledge outside of work. Evaluating the impact of workplace (mHealth-based or not) interventions at work but also away from work would provide a better understating of the impact of such interventions.",2020,"Compared to the A-CG, employees that used the W@W-App program increased their number of daily breaks and the time spent on short sedentary bouts (<20 min, p = 0.047) during weekends.","['Participants ( n = 141', '41 physical activity (PA) and sitting in desk-based employees at-work and away from work']","[""13-week m-40 health workplace-based 'sit less, move more' intervention (Walk@WorkApp; W@W-App"", 'workplace (mHealth-based or not) interventions']","['number of daily breaks and the time spent on short sedentary bouts', 'total sitting time, sedentary bouts and breaks, and light and moderate-to-vigorous PA (activPAL3TM', 'shortest sedentary bouts', 'workday PA or sitting']","[{'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0213052', 'cui_str': 'M40'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",141.0,0.0254173,"Compared to the A-CG, employees that used the W@W-App program increased their number of daily breaks and the time spent on short sedentary bouts (<20 min, p = 0.047) during weekends.","[{'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Bort-Roig', 'Affiliation': 'Sport and Physical Activity Research Group, Centre for Health and Social Care Research, University of Vic-Central University of Catalonia, 08500 Barcelona, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Chirveches-Pérez', 'Affiliation': 'Research Group on Methodology, Methods, Models and Outcomes of Health and Social Sciences (M3O), Centre for Health and Social Care Research, University of Vic-Central University of Catalonia, 08500 Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giné-Garriga', 'Affiliation': 'Department of Physical Activity and Sport Sciences, Faculty of Psychology, Education and Sport Sciences (FPCEE) Blanquerna, Ramon Llull University, 08022 Barcelona, Spain.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Navarro-Blasco', 'Affiliation': 'Occupational Health Service, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Bausà-Peris', 'Affiliation': 'Occupational Health Service, Hospital de la Santa Creu i Sant Pau, 08041 Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Iturrioz-Rosell', 'Affiliation': 'Unidad Docente Pluridisciplinar de Atención Familiar y Comunitaria, Hospital Universitario de Donostia, 20014 Donostia-San Sebastián, Spain.'}, {'ForeName': 'Angel M', 'Initials': 'AM', 'LastName': 'González-Suárez', 'Affiliation': 'Department of Physical Education and Sport, University of the Basque Country, 01007 Vitoria-Gasteiz, Spain.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Martínez-Lemos', 'Affiliation': 'Well-Move Research Group (HI-23), Faculty of Educational Sciences and Sports, University of Vigo, 36005 Pontevedra, Spain.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Puigoriol-Juvanteny', 'Affiliation': 'Tissue Repair and Regeneration Laboratory (TR2Lab), Faculty of Sciences and Technology, University of Vic-Central University of Catalonia, 08500 Vic, Barcelona, Spain.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dowd', 'Affiliation': 'Department of Sport and Health Sciences, Athlone Institute of Technology, N37 HD68 Athlone, Co. Westmeath, Ireland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Puig-Ribera', 'Affiliation': 'Sport and Physical Activity Research Group, Centre for Health and Social Care Research, University of Vic-Central University of Catalonia, 08500 Barcelona, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17238844']
2533,33260580,The Effect of Traditional and Stabilization-Oriented Exercises on Deep Stabilization System Function in Elite Futsal Players.,"BACKGROUND
This study aimed to compare the effect of traditional and stability-oriented strength exercises on trunk stability and deep stabilization system (DSS) activation in elite futsal players.
METHODS
Twenty elite futsal players (21-34 years, 180 ± 13 cm, 79 ± 15 kg) were randomly divided into a group that performed stability-oriented exercises and a group that performed traditional strength exercises. Both interventions lasted for 10 weeks and included 25 strength training sessions.
MAIN OUTCOME MEASURES
The DSS pretest and posttest included the diaphragm test, trunk flexion test, back extension test, hip flexion test, intraabdominal pressure test, and a side plank test on a 1-5 point scale.
RESULTS
Both groups had similar initial test results, where the stability-oriented exercise group had significantly improved intraabdominal pressure test ( p = 0.004, by lower quartile rate), trunk flexion ( p = 0.036, by 0.5 grade in median), and side plank ( p = 0.002, by 1 grade in median) in posttest results. Traditional exercise did not change the results of any of the included DSS function tests.
CONCLUSIONS
Stabilization-oriented exercises effectively activate the functions of the DSS and should be prioritized over traditional strength exercises in injury prevention training programs. The use of stabilization-oriented exercises might prevent injury and overloading in elite futsal players.",2020,"Both groups had similar initial test results, where the stability-oriented exercise group had significantly improved intraabdominal pressure test ( p = 0.004, by lower quartile rate), trunk flexion ( p = 0.036, by 0.5 grade in median), and side plank ( p = 0.002, by 1 grade in median) in posttest results.","['Twenty elite futsal players (21-34 years, 180 ± 13 cm, 79 ± 15 kg', 'elite futsal players', 'Elite Futsal Players']","['stabilization-oriented exercises', 'traditional and stability-oriented strength exercises', 'Traditional and Stabilization-Oriented Exercises', 'stability-oriented exercises and a group that performed traditional strength exercises']","['side plank', 'trunk flexion', 'trunk stability and deep stabilization system (DSS) activation', 'intraabdominal pressure test', 'diaphragm test, trunk flexion test, back extension test, hip flexion test, intraabdominal pressure test, and a side plank test on a 1-5 point scale']","[{'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319557', 'cui_str': '180'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0231901', 'cui_str': 'Intraabdominal pressure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0193456,"Both groups had similar initial test results, where the stability-oriented exercise group had significantly improved intraabdominal pressure test ( p = 0.004, by lower quartile rate), trunk flexion ( p = 0.036, by 0.5 grade in median), and side plank ( p = 0.002, by 1 grade in median) in posttest results.","[{'ForeName': 'Radim', 'Initials': 'R', 'LastName': 'Jebavy', 'Affiliation': 'Department of Track and Field, Faculty of Physical Education and Sport, Charles University, 16252 Prague, Czech Republic.'}, {'ForeName': 'Jiří', 'Initials': 'J', 'LastName': 'Baláš', 'Affiliation': 'Sport Research Center, Faculty of Physical Education and Sport, Charles University, 16252 Prague, Czech Republic.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Vomackova', 'Affiliation': 'Department of Physiotherapy, Faculty of Physical Education and Sport, Charles University, 16252 Prague, Czech Republic.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Szarzec', 'Affiliation': 'Faculty of Nursing and Professional Health Studies, Health University in Bratislava, 83101 Bratislava, Slovakia.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastny', 'Affiliation': 'Department of Sport Games, Faculty of Physical Education and Sport, Charles University, 16252 Prague, Czech Republic.'}]","Sports (Basel, Switzerland)",['10.3390/sports8120153']
2534,33260560,"Effects of Yeast Mannan Which Promotes Beneficial Bacteroides on the Intestinal Environment and Skin Condition: A Randomized, Double-Blind, Placebo-Controlled Study.","Yeast mannan (YM) is an indigestible water-soluble polysaccharide of the yeast cell wall. In vitro fecal fermentation studies showed that YM could exhibit a notable prebiotic effect. The aim of this randomized, double-blind, placebo-controlled study was to assess the efficacy of YM intake on the intestinal environment and skin condition. One hundred and ten healthy female subjects aged 30-49 years were supplemented with YM or placebo for eight weeks. Skin dryness was set as the primary endpoint. No side effects were observed during the study. Microbiota analyses revealed that YM intake selectively increased the relative abundance of Bacteroides thetaiotaomicron and Bacteroides ovatus compared to that by placebo. Feces and urine analyses showed that YM intake lowered the concentration of fecal p -cresol, indole, and skatole, and elevated urinal equol levels compared to those in placebo. Furthermore, YM supplementation ameliorated subjective skin dryness. This study suggests that YM intake could promote beneficial Bacteroides and improve the intestinal environment and skin condition.",2020,"Feces and urine analyses showed that YM intake lowered the concentration of fecal p -cresol, indole, and skatole, and elevated urinal equol levels compared to those in placebo.",['One hundred and ten healthy female subjects aged 30-49 years'],"['placebo', 'YM or placebo', 'YM supplementation', 'Placebo', 'Yeast Mannan']","['concentration of fecal p -cresol, indole, and skatole, and elevated urinal equol levels', 'Skin dryness', 'side effects', 'intestinal environment and skin condition', 'subjective skin dryness', 'relative abundance of Bacteroides thetaiotaomicron and Bacteroides ovatus']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3489117', 'cui_str': 'Yeast mannan preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0048212', 'cui_str': '4-cresol'}, {'cui': 'C0021236', 'cui_str': 'indole'}, {'cui': 'C0037248', 'cui_str': 'Skatole'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184219', 'cui_str': 'Urinals'}, {'cui': 'C0059497', 'cui_str': 'Equol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",110.0,0.279605,"Feces and urine analyses showed that YM intake lowered the concentration of fecal p -cresol, indole, and skatole, and elevated urinal equol levels compared to those in placebo.","[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Tanihiro', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Sakano', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oba', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}, {'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Nakamura', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}, {'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Ohki', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}, {'ForeName': 'Tatsuhiko', 'Initials': 'T', 'LastName': 'Hirota', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Sugiyama', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}, {'ForeName': 'Shukuko', 'Initials': 'S', 'LastName': 'Ebihara', 'Affiliation': 'Chiyoda Paramedical Care Clinic, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo 101-0047, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Core Technology Laboratories, Asahi Quality and Innovations, Ltd., 1-21, Midori 1-chome, Moriya-shi, Ibaraki 302-0106, Japan.'}]",Nutrients,['10.3390/nu12123673']
2535,33272960,Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2.,"BACKGROUND
Upadacitinib is a Janus kinase inhibitor under evaluation for the treatment of psoriatic arthritis (PsA). We evaluated upadacitinib in patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD).
METHODS
In this 24-week randomised, placebo-controlled, double-blind, phase 3 trial, 642 patients were randomised (2:2:1:1) to once per day upadacitinib 15 mg or 30 mg, placebo followed by upadacitinib 15 mg or placebo followed by upadacitinib 30 mg at week 24. The primary endpoint was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 12. Achievement of minimal disease activity (MDA) was assessed at week 24. Treatment-emergent adverse events are reported for all patients who received at least one dose of trial drug.
RESULTS
At week 12, significantly more patients receiving upadacitinib 15 mg and 30 mg versus placebo achieved ACR20 (56.9% and 63.8% vs 24.1%; p<0.001 for both comparisons). At week 24, MDA was achieved by more upadacitinib 15 mg-treated (25.1%) and 30 mg-treated patients (28.9%) versus placebo (2.8%; p<0.001 for both comparisons). Generally, the rates of treatment-emergent adverse events were similar with placebo and upadacitinib 15 mg and higher with upadacitinib 30 mg at week 24. Rates of serious infections were 0.5%, 0.5% and 2.8% with placebo, upadacitinib 15 mg and upadacitinib 30 mg, respectively.
CONCLUSION
In this trial of patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD, upadacitinib 15 mg and 30 mg was more effective than placebo over 24 weeks in improving signs and symptoms of PsA.
CLINICAL TRIAL REGISTRATION NUMBER
NCT03104374.",2020,"Generally, the rates of treatment-emergent adverse events were similar with placebo and upadacitinib 15 mg and higher with upadacitinib 30 mg at week 24.","['642 patients', 'patients with PsA and prior inadequate response or intolerance to at least one biologic disease-modifying antirheumatic drug (DMARD', 'patients with active PsA who had inadequate response or intolerance to at least one biologic DMARD']","['upadacitinib 15 mg or 30 mg, placebo followed by upadacitinib 15 mg or placebo', 'placebo']","['rates of treatment-emergent adverse events', 'ACR20', 'Rates of serious infections', 'Achievement of minimal disease activity (MDA', 'proportion of patients achieving American College of Rheumatology (ACR) 20 response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C5196293', 'cui_str': 'upadacitinib 15 MG [Rinvoq]'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}]",642.0,0.328747,"Generally, the rates of treatment-emergent adverse events were similar with placebo and upadacitinib 15 mg and higher with upadacitinib 30 mg at week 24.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Rheumatology, Swedish Medical Center, Seattle, Washington, USA pmease@philipmease.com.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Lertratanakul', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Jaclyn K', 'Initials': 'JK', 'LastName': 'Anderson', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K Papp Clinical Research Inc, Waterloo, Ontario, Canada.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Van den Bosch', 'Affiliation': 'Department of Internal Medicine and Pediatrics, Ghent University, VIB Center for Inflammation Research, Ghent, Belgium, Gent, Belgium.'}, {'ForeName': 'Shigeyoshi', 'Initials': 'S', 'LastName': 'Tsuji', 'Affiliation': 'Department of Orthopaedics/Rheumatology, National Hospital Organization, Osaka Minami Medical Center, Kawachi-Nagano, Japan.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilova', 'Affiliation': 'Medical Plus, Uherske Hradiste, Czech Republic.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Keiserman', 'Affiliation': 'Rheumatology Section, Pontifical Catholic University, School of Medicine, Porto Alegre, Brazil.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Reva M', 'Initials': 'RM', 'LastName': 'McCaskill', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Zueger', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'Aileen L', 'Initials': 'AL', 'LastName': 'Pangan', 'Affiliation': 'AbbVie Inc, North Chicago, Illinois, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Department of Rheumatology, Royal National Hospital for Rheumatic Disease, Bath, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-218870']
2536,33272959,Non-surgical and surgical treatments for rotator cuff disease: a pragmatic randomised clinical trial with 2-year follow-up after initial rehabilitation.,"BACKGROUND
Rotator cuff disease (RCD) causes prolonged shoulder pain and disability in adults. RCD is a continuum ranging from tendinopathy to full-thickness tendon tear. Recent studies have shown that subacromial decompression and non-surgical treatments provide equivalent results in RCD without a full-thickness tendon lesion. However, the importance of surgery for full-thickness tendon tears remains unclear.
METHODS
In a pragmatic, randomised, controlled trial, 417 patients with subacromial pain underwent 3-month initial rehabilitation and MRI arthrography (MRA) for the diagnosis of RCD. Of these, 190 shoulders remained symptomatic and were randomised to non-surgical or surgical treatments. The primary outcomes were the mean changes in the Visual Analogue Scale for pain and the Constant Murley Score for shoulder function at the 2-year follow-up.
RESULTS
At the 2-year follow-up, both non-surgical and surgical treatments for RCD reduced pain and improved shoulder function. The scores differed between groups by 4 (95% CI -3 to 10, p=0.25) for pain and 3.4 (95% CI -0.4 to 7.1, p=0.077) for function. Among patients with full-thickness ruptures, the reduction in pain (13, 95% CI 5 to 22, p=0.002) and improvement in function (7.0, 95% CI 1.8 to 12.2, p=0.008) favoured surgery.
CONCLUSIONS
Non-surgical and surgical treatments for RCD provided equivalent improvements in pain and function. Therefore, we recommend non-surgical treatment as the primary choice for patients with RCD. However, surgery yielded superior improvement in pain and function for full-thickness rotator cuff rupture. Therefore, rotator cuff repair may be suggested after failed non-surgical treatment.
TRIAL REGISTRATION DETAILS
ClinicalTrials.gov, NCT00695981 and NCT00637013.",2020,"At the 2-year follow-up, both non-surgical and surgical treatments for RCD reduced pain and improved shoulder function.","['190 shoulders remained symptomatic', 'patients with RCD', 'rotator cuff disease', '417 patients with subacromial pain underwent 3-month', 'Rotator cuff disease (RCD) causes prolonged shoulder pain and disability in adults']","['RCD', 'initial rehabilitation and MRI arthrography (MRA']","['pain and improved shoulder function', 'pain and function', 'mean changes in the Visual Analogue Scale for pain and the Constant Murley Score for shoulder function', 'improvement in function', 'pain']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C5191297', 'cui_str': '417'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0412721', 'cui_str': 'MRI arthrography'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",417.0,0.138606,"At the 2-year follow-up, both non-surgical and surgical treatments for RCD reduced pain and improved shoulder function.","[{'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Cederqvist', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, Finland sanna.cederqvist@icloud.com.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Flinkkilä', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Medical Research Center, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Sormaala', 'Affiliation': 'Department of Radiology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Ylinen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Kautiainen', 'Affiliation': 'Research Center, Folkhälsan, Helsinki, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Irmola', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lehtokangas', 'Affiliation': 'Department of Orthopaedics and Traumatology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Juho', 'Initials': 'J', 'LastName': 'Liukkonen', 'Affiliation': 'Department of Emergency Medicine, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Konsta', 'Initials': 'K', 'LastName': 'Pamilo', 'Affiliation': 'Department of Surgery, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Ridanpää', 'Affiliation': 'Department of Surgery, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Sirniö', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Medical Research Center, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Juhana', 'Initials': 'J', 'LastName': 'Leppilahti', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Medical Research Center, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Ilkka', 'Initials': 'I', 'LastName': 'Kiviranta', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Paloneva', 'Affiliation': 'Department of Surgery, Central Finland Central Hospital, Jyväskylä, Finland.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-219099']
2537,33272946,Weekly iron-folic acid supplements containing 2.8 mg folic acid are associated with a lower risk of neural tube defects than the current practice of 0.4 mg: a randomised controlled trial in Malaysia.,"INTRODUCTION
Weekly iron-folic acid (IFA) supplements are recommended for all menstruating women in countries where anaemia prevalence is >20%. Anaemia caused by folate deficiency is low worldwide, and the need to include folic acid is in question. Including folic acid might reduce the risk of a neural tube defect (NTD) should a woman become pregnant. Most weekly supplements contain 0.4 mg folic acid; however, WHO recommends 2.8 mg because it is seven times the daily dose effective in reducing NTDs. There is a reluctance to switch to supplements containing 2.8 mg of folic acid because of a lack of evidence that this dose would prevent NTDs. Our aim was to investigate the effect of two doses of folic acid, compared with placebo, on red blood cell (RBC) folate, a biomarker of NTD risk.
METHODS
We conducted a three-arm double-blind efficacy trial in Malaysia. Non-pregnant women (n=331) were randomised to receive 60 mg iron and either 0, 0.4, or 2.8 mg folic acid once weekly for 16 weeks.
RESULTS
At 16 weeks, women receiving 0.4 mg and 2.8 mg folic acid per week had a higher mean RBC folate than those receiving 0 mg (mean difference (95% CI) 84 (54 to 113) and 355 (316 to 394) nmol/L, respectively). Women receiving 2.8 mg folic acid had a 271 (234 to 309) nmol/L greater mean RBC folate than those receiving 0.4 mg. Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7; p<0.0001) more likely to achieve an RBC folate >748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group.
CONCLUSION
Weekly IFA supplements containing 2.8 mg folic acid increases RBC folate more than those containing 0.4 mg. Increased availability and access to the 2.8 mg formulation is needed.
TRAIL REGISTRATION NUMBER
This trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12619000818134).",2020,"Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7; p<0.0001) more likely to achieve an RBC folate >748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group.
","['Women receiving 2.8\u2009mg folic acid had a 271 (234 to 309', 'Malaysia. Non-pregnant women (n=331']","['placebo', 'supplements contain 0.4 mg folic acid', '60\u2009mg iron and either 0, 0.4, or 2.8\u2009mg folic acid', 'folic acid', 'Weekly iron-folic acid (IFA) supplements', 'Weekly iron-folic acid supplements containing 2.8 mg folic acid']","['red blood cell (RBC) folate, a biomarker of NTD risk', 'lower risk of neural tube defects', 'mean RBC folate', 'RBC folate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}]","[{'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0027794', 'cui_str': 'Neural tube defect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427418', 'cui_str': 'Folic acid measurement, RBC'}]",,0.230185,"Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7; p<0.0001) more likely to achieve an RBC folate >748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group.
","[{'ForeName': 'Kaitlyn L I', 'Initials': 'KLI', 'LastName': 'Samson', 'Affiliation': 'Food, Nutrition, and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Su Peng', 'Initials': 'SP', 'LastName': 'Loh', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Siew Siew', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Dian C', 'Initials': 'DC', 'LastName': 'Sulistyoningrum', 'Affiliation': 'SAHMRI Women and Kids, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Geok Lin', 'Initials': 'GL', 'LastName': 'Khor', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Zalilah Binti Mohd', 'Initials': 'ZBM', 'LastName': 'Shariff', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Irmi Zarina', 'Initials': 'IZ', 'LastName': 'Ismai', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Selangor, Malaysia.'}, {'ForeName': 'Lisa N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'SAHMRI Women and Kids, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Shalem', 'Initials': 'S', 'LastName': 'Leemaqz', 'Affiliation': 'SAHMRI Women and Kids, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Hutcheon', 'Affiliation': ""Healthy Starts, British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Marion L', 'Initials': 'ML', 'LastName': 'Roche', 'Affiliation': 'Nutrition International, Ottawa, Ontario, Canada.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Food, Nutrition, and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Green', 'Affiliation': 'SAHMRI Women and Kids, South Australia Health and Medical Research Institute, Adelaide, South Australia, Australia tim.green@sahmri.com.'}]",BMJ global health,['10.1136/bmjgh-2020-003897']
2538,33272923,Smoking Behaviors Among Tobacco-Using Parents of Hospitalized Children and Association With Child Cotinine Level.,"OBJECTIVES
Understanding patterns of parental tobacco use and their association with child exposure can help us target interventions more appropriately. We aimed to examine the association between parental smoking practices and cotinine levels of hospitalized children.
METHODS
This is a secondary analysis of data collected from parents of hospitalized children, recruited for a cessation intervention randomized controlled trial. Smoking parents were identified by using a medical record screening question. Parent-reported demographics and smoking habits were compared to child urine cotinine by using geometric means and log-transformed cotinine levels in multivariable linear regression analyses.
RESULTS
A total of 213 patients had complete baseline parent-interview and urine cotinine data. The median age was 4 (interquartile range: 1-9); 57% were boys; 56% were white, 12% were Black, and 23% were multiracial; 36% identified as Hispanic. Most families (54%) had 1 smoker in the home; 36% had 2, and 9% had ≥3. Many (77%) reported having a ban on smoking in the home, and 86% reported smoking only outside. The geometric mean cotinine level of the cohort was 0.98 ng/mL. Higher cotinine levels were associated with more smokers in the home (ratio of 2.99) and smoking inside the house (ratio of 4.11).
CONCLUSIONS
Having more smokers in the home and parents who smoke inside are associated with increased smoke exposure; however, even children whose families who smoke only outside the home have significant levels of cotinine, a marker for toxin exposure.",2020,"The geometric mean cotinine level of the cohort was 0.98 ng/mL. Higher cotinine levels were associated with more smokers in the home (ratio of 2.99) and smoking inside the house (ratio of 4.11).
","['hospitalized children', 'The median age was 4 (interquartile range: 1-9); 57% were boys; 56% were white, 12% were Black, and 23% were multiracial; 36% identified as Hispanic', '213 patients had complete baseline parent-interview and urine cotinine data', 'parents of hospitalized children']",[],"['Smoking Behaviors', 'geometric mean cotinine level']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C1697737', 'cui_str': 'Urine cotinine test'}]",[],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",213.0,0.0311409,"The geometric mean cotinine level of the cohort was 0.98 ng/mL. Higher cotinine levels were associated with more smokers in the home (ratio of 2.99) and smoking inside the house (ratio of 4.11).
","[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Wilson', 'Affiliation': 'Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York City, New York; karen.wilson@mssm.edu.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Moss', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Lowary', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gambino', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado.""}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Klein', 'Affiliation': 'Julius B. Richmond Center of Excellence, American Academy of Pediatrics, Itasca, Illinois.'}, {'ForeName': 'Gwendolyn S', 'Initials': 'GS', 'LastName': 'Kerby', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Melbourne', 'Initials': 'M', 'LastName': 'Hovell', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, College of Health and Human Sciences, San Diego State University, San Diego, California.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Winickoff', 'Affiliation': 'Julius B. Richmond Center of Excellence, American Academy of Pediatrics, Itasca, Illinois.'}]",Hospital pediatrics,['10.1542/hpeds.2020-0122']
2539,33270009,"Nicotine replacement treatment, e-cigarettes and an online behavioural intervention to reduce relapse in recent ex-smokers: a multinational four-arm RCT.","BACKGROUND
Relapse remains an unresolved issue in smoking cessation. Extended stop smoking medication use can help, but uptake is low and several behavioural relapse prevention interventions have been found to be ineffective. However, opportunistic 'emergency' use of fast-acting nicotine replacement treatment or electronic cigarettes may be more attractive and effective, and an online behavioural Structured Planning and Prompting Protocol has shown promise. The present trial aimed to evaluate the clinical effectiveness and cost-effectiveness of these two interventions.
DESIGN
A randomised controlled trial.
SETTING
English stop smoking services and Australian quitlines, Australian social media and St Vincent's Hospital Melbourne, Fitzroy, VIC.
PARTICIPANTS
Ex-smokers abstinent for at least 4 weeks, with some participants in Australia also recruited from 1 week post quit date. The planned sample size was 1400, but the trial was curtailed when 235 participants were recruited.
INTERVENTIONS
Participants were randomised in permuted blocks of random sizes to (1) oral nicotine replacement treatment/electronic cigarettes to use if at risk of relapse, plus static text messages ( n = 60), (2) the Structured Planning and Prompting Protocol and interactive text messages ( n = 57), (3) oral nicotine replacement treatment/electronic cigarettes plus the Structured Planning and Prompting Protocol with interactive text messages ( n = 58) or (4) usual care plus static text messages ( n = 59).
OUTCOME MEASURES
Owing to delays in study set-up and recruitment issues, the study was curtailed and the primary outcome was revised. The original objective was to determine whether or not the two interventions, together or separately, reduced relapse rates at 12 months compared with usual care. The revised primary objective was to determine whether or not number of interventions received (i.e. none, one or two) affects relapse rate at 6 months (not biochemically validated because of study curtailment). Relapse was defined as smoking on at least 7 consecutive days, or any smoking in the last month at final follow-up for both the original and curtailed outcomes. Participants with missing outcome data were included as smokers. Secondary outcomes included sustained abstinence (i.e. no more than five cigarettes smoked over the 6 months), nicotine product preferences (e.g. electronic cigarettes or nicotine replacement treatment) and Structured Planning and Prompting Protocol coping strategies used. Two substudies assessed reactions to interventions quantitatively and qualitatively. The trial statistician remained blinded until analysis was complete.
RESULTS
The 6-month relapse rates were 60.0%, 43.5% and 49.2% in the usual-care arm, one-intervention arm and the two-intervention arm, respectively ( p = 0.11). Sustained abstinence rates were 41.7%, 54.8% and 50.9%, respectively ( p = 0.17). Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57). Of participants allocated to nicotine products, 23.1% were using them daily at 6 months. The online intervention received positive ratings from 63% of participants at 6 months, but the majority of participants (72%) completed one assessment only. Coping strategies taught in the Structured Planning and Prompting Protocol were used with similar frequency in all study arms, suggesting that these are strategies people had already acquired. Only one participant used the interactive texting, and interactive and static messages received virtually identical ratings.
LIMITATIONS
The inability to recruit sufficient participants resulted in a lack of power to detect clinically relevant differences. Self-reported abstinence was not biochemically validated in the curtailed trial, and the ecological momentary assessment substudy was perceived by some as an intervention.
CONCLUSIONS
Recruiting recent ex-smokers into an interventional study proved problematic. Both interventions were well received and safe. Combining the interventions did not surpass the effects of each intervention alone. There was a trend in favour of single interventions reducing relapse, but it did not reach significance and there are reasons to interpret the trend with caution.
FUTURE WORK
Further studies of both interventions are warranted, using simpler study designs.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN11111428.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 68. See the NIHR Journals Library website for further project information. Funding was also provided by the National Health and Medical Research Council, Canberra, ACT, Australia (NHMRC APP1095880). Public Health England provided the funds to purchase the nicotine products in England.",2020,"Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57).","['235 participants were recruited', ""English stop smoking services and Australian quitlines, Australian social media and St Vincent's Hospital Melbourne, Fitzroy, VIC"", 'Ex-smokers abstinent for at least 4 weeks, with some participants in Australia also recruited from 1 week post quit date', 'Participants with missing outcome data were included as smokers']","['Nicotine replacement treatment, e-cigarettes and an online behavioural intervention', 'nicotine', 'nicotine replacement treatment/electronic cigarettes plus the Structured Planning and Prompting Protocol with interactive text messages ( n \u2009=\u200958) or (4) usual care plus static text messages', 'nicotine replacement treatment/electronic cigarettes to use if at risk of relapse, plus static text messages ( n \u2009=\u200960), (2) the Structured Planning and Prompting Protocol and interactive text messages']","['sustained abstinence (i.e. no more than five cigarettes smoked over the 6 months), nicotine product preferences (e.g. electronic cigarettes or nicotine replacement treatment) and Structured Planning and Prompting Protocol coping strategies used', 'clinical effectiveness and cost-effectiveness', 'Sustained abstinence rates', 'relapse rates', 'Electronic cigarettes', '6-month relapse rates', 'Relapse', 'relapse rate']","[{'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",235.0,0.122172,"Electronic cigarettes were chosen more frequently than nicotine replacement treatment in Australia (71.1% vs. 29.0%; p = 0.001), but not in England (54.0% vs. 46.0%; p = 0.57).","[{'ForeName': 'Hayden J', 'Initials': 'HJ', 'LastName': 'McRobbie', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'El Zerbi', 'Affiliation': ""Cancer Prevention Group, School of Cancer & Pharmaceutical Sciences, Faculty of Medicine and Life Sciences, King's College London, London, UK.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': ""Cancer Prevention Group, School of Cancer & Pharmaceutical Sciences, Faculty of Medicine and Life Sciences, King's College London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""Cancer Prevention Group, School of Cancer & Pharmaceutical Sciences, Faculty of Medicine and Life Sciences, King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Balmford', 'Affiliation': 'Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Ferguson', 'Affiliation': 'College of Health and Medicine, University of Tasmania, Hobart, TAS, Australia.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Clinical Sciences Building, University of Nottingham, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Courtney', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Gartner', 'Affiliation': 'School of Public Health, Faculty of Medicine, University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Bauld', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Borland', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, VIC, Australia.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24680']
2540,33269975,Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study.,"BACKGROUND
Sex steroids could explain the course of multiple sclerosis (MS) in pregnancy.
OBJECTIVE
To compare the annualized relapse rate (ARR) 12 weeks post-partum in women treated with nomegestrol acetate (NOMAc) and 17-beta-estradiol (E2) versus placebo.
METHODS
POPARTMUS is a randomized, proof-of-concept trial in women with MS, receiving oral NOMAc 10 mg/day and transdermal estradiol 75 µg/week, or placebo.
RESULTS
Recruitment was stopped prematurely due to slow inclusions ( n = 202). No treatment effect was observed on ARR after 12 weeks (sex steroids = 0.90 (0.58-1.39), placebo = 0.97 (0.63-1.50) ( p = 0.79)).
CONCLUSION
POPARTMUS failed showing efficacy of a NOMAc-E2 combination in preventing post-partum relapses.",2020,"No treatment effect was observed on ARR after 12 weeks (sex steroids = 0.90 (0.58-1.39), placebo = 0.97 (0.63-1.50) ( p = 0.79)).
","['women with MS, receiving', 'multiple sclerosis']","['Oral nomegestrol acetate and transdermal 17-beta-estradiol', 'nomegestrol acetate (NOMAc) and 17-beta-estradiol (E2) versus placebo', 'oral NOMAc 10\u2009mg/day and transdermal estradiol 75\u2009µg/week, or placebo', 'placebo']","['ARR', 'annualized relapse rate (ARR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0132749', 'cui_str': 'Nomegestrol acetate'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0802177,"No treatment effect was observed on ARR after 12 weeks (sex steroids = 0.90 (0.58-1.39), placebo = 0.97 (0.63-1.50) ( p = 0.79)).
","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Vukusic', 'Affiliation': 'Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France/Centre des Neurosciences de Lyon, INSERM 1028 et CNRS UMR5292, Observatoire Français de la Sclérose en Plaques, Lyon, France/Université Claude Bernard Lyon 1, Villeurbanne, France.'}, {'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Ionescu', 'Affiliation': 'Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cornu', 'Affiliation': ""Centre d'Investigation Clinique INSERM1407, Hospices Civils de Lyon, Lyon, France/Service de Pharmaco-toxicologie, Lyon, France/UMR5558, Claude Bernard University, Lyon, France.""}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bossard', 'Affiliation': 'Hospices Civils de Lyon, Pôle Santé Publique, Service de Biostatistique-Bioinformatique, Lyon, France/Université de Lyon, Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Durand-Dubief', 'Affiliation': 'Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France/CREATIS, UMR 5220 CNRS & U1044 Inserm, Université Claude Bernard Lyon1, Université de Lyon, Villeurbanne, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Cotton', 'Affiliation': 'CREATIS, UMR 5220 CNRS & U1044 Inserm, Université Claude Bernard Lyon1, Université de Lyon, Villeurbanne, France/Service de Radiologie, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Durelli', 'Affiliation': 'Clinical and Biological Sciences Department, University of Torino, Turin, Italy.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Marignier', 'Affiliation': 'Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France/Université Claude Bernard Lyon 1, Villeurbanne, France/Centre des Neurosciences de Lyon, INSERM 1028 et CNRS UMR5292, Fluid team, Lyon, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Gignoux', 'Affiliation': 'Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation et Fondation Eugène Devic EDMUS pour la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Lyon-Bron, France.'}, {'ForeName': 'David-Axel', 'Initials': 'DA', 'LastName': 'Laplaud', 'Affiliation': 'CHU de Nantes, Service de Neurologie & CIC015 INSERM, Nantes, France, INSERM CR1064, Nantes, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Moreau', 'Affiliation': 'Department of Neurology, EA4184, University Hospital of Dijon, Dijon, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Clavelou', 'Affiliation': ""Service de Neurologie, CHU Clermont-Ferrand, Clermont-Ferrand, France/Inserm U1107, Clermont Université, Université d'Auvergne, Neuro-Dol, Clermont-Ferrand, France.""}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'De Seze', 'Affiliation': 'Department of Neurology and Clinical Investigation Center, CHU de Strasbourg, INSERM, Strasbourg, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debouverie', 'Affiliation': 'EA 4360 Apemac, Lorraine University, Nancy, France/Department of Neurology, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brassat', 'Affiliation': 'Pôle Neurosciences, CHU Toulouse Purpan, Toulouse, France/INSERM U1043-CNRS UMR 5282, Université Toulouse III, Toulouse, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Pelletier', 'Affiliation': 'Aix Marseille Univ, APHM, Hôpital de la Timone, Pôle de Neurosciences Cliniques, Service de Neurologie, Marseille, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebrun-Frenay', 'Affiliation': 'CRCSEP Department of Neurology, UR2CA URRIS, Nice, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Le Page', 'Affiliation': 'Clinical Neuroscience Centre, CIC-P 1414 INSERM, Rennes University Hospital, Rennes, France.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Castelnovo', 'Affiliation': 'Department of Neurology, CHU Nîmes, Hôpital Caremeau, Nîmes Cedex, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berger', 'Affiliation': 'Department of Neurology, CHU Besançon, Besançon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Hautecoeur', 'Affiliation': ""Service de Neurologie, Groupe Hospitalier de l'Institut Catholique de Lille, Lille Cedex, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Heinzlef', 'Affiliation': 'Neurology Department, Hospital of Poissy-St-Germain en Laye, Paris, France.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Trojano', 'Affiliation': 'Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, Bari, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Patti', 'Affiliation': 'Department of Medical and Surgical Sciences, and Advanced Technologies, GF Ingrassia, Multiple Sclerosis Center, University of Catania, Catania, Italy.'}, {'ForeName': 'Etienne-Emile', 'Initials': 'EE', 'LastName': 'Baulieu', 'Affiliation': 'INSERM U 1195, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Remontet', 'Affiliation': 'Hospices Civils de Lyon, Pôle Santé Publique, Service de Biostatistique-Bioinformatique, Lyon, France/Université de Lyon, Université Lyon 1, CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Évolutive, Équipe Biostatistique-Santé, Villeurbanne, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'El-Etr', 'Affiliation': 'INSERM U 1195, Le Kremlin-Bicêtre, France.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458520978218']
2541,33269951,"Reversion from chronic migraine to episodic migraine following treatment with erenumab: Results of a post-hoc analysis of a randomized, 12-week, double-blind study and a 52-week, open-label extension.","OBJECTIVE
To determine reversion rates from chronic migraine to episodic migraine during long-term erenumab treatment.
METHODS
A daily headache diary was completed during the 12-week, double-blind treatment phase of a placebo-controlled trial comparing erenumab 70 mg, 140 mg, and placebo, and weeks 1-12, 21-24, 37-40, and 49-52 of the open-label treatment phase. Chronic migraine to episodic migraine reversion rates were assessed over the double-blind treatment phase; persistent reversion to episodic migraine over 24 weeks (double-blind treatment phase through the first 12 weeks in the open-label treatment phase), long-term persistent reversion to episodic migraine over 64 weeks (double-blind treatment phase plus open-label treatment phase); delayed reversion to episodic migraine through the first 12 weeks of the open-label treatment phase among patients remaining in chronic migraine during the double-blind treatment phase.
RESULTS
In the double-blind treatment phase, 53.1% (95% confidence interval: 47.8-58.3) of 358 erenumab-treated completers had reversion to episodic migraine; monthly reversion rates to episodic migraine were typically higher among patients receiving 140 mg versus 70 mg. Among 181 completers (receiving erenumab for 64 weeks), 98 (54.1% [95% confidence interval: 46.6-61.6]) had reversion to episodic migraine during the double-blind treatment phase; of those, 96.9% (95% confidence interval: 91.3-99.4) had persistent reversion to episodic migraine, 96.8% (95% confidence interval: 91.1-99.3) of whom had long-term persistent reversion to episodic migraine. Delayed reversion to episodic migraine occurred in 36/83 (43.4% [95% confidence interval: 32.5-54.7]) patients; of these, 77.8% (95% confidence interval: 60.9-89.9) persisted in reversion through week 64.
CONCLUSIONS
Patients with reversion to episodic migraine at week 12 will likely persist as episodic migraine with longer-term erenumab; others may achieve delayed reversion to episodic migraine. Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02066415.",2020,"In the double-blind treatment phase, 53.1% (95% confidence interval: 47.8-58.3) of 358 erenumab-treated completers had reversion to episodic migraine; monthly reversion rates to episodic migraine were typically higher among patients receiving 140 mg versus 70 mg.",[],"['erenumab', 'long-term persistent reversion to episodic migraine over 64 weeks (double-blind treatment phase plus open-label treatment phase); delayed reversion to episodic migraine', 'erenumab 70\u2009mg, 140\u2009mg, and placebo', 'placebo']","['reversion to episodic migraine', 'Delayed reversion to episodic migraine', 'reversion to episodic migraine; monthly reversion rates to episodic migraine', 'persistent reversion to episodic migraine']",[],"[{'cui': 'C4542165', 'cui_str': 'erenumab'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]",,0.323713,"In the double-blind treatment phase, 53.1% (95% confidence interval: 47.8-58.3) of 358 erenumab-treated completers had reversion to episodic migraine; monthly reversion rates to episodic migraine were typically higher among patients receiving 140 mg versus 70 mg.","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Stewart J', 'Initials': 'SJ', 'LastName': 'Tepper', 'Affiliation': 'Geisel School of Medicine at Dartmouth, Hanover, NH, USA.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Silberstein', 'Affiliation': 'Jefferson Headache Center, Philadelphia, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kudrow', 'Affiliation': 'California Medical Clinic for Headache, Santa Monica, CA, USA.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Global Biostatistical Science, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Rippon', 'Affiliation': 'Global Medical Affairs, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Sunfa', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Mikol', 'Affiliation': 'Global Development, Amgen Inc., Thousand Oaks, CA, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420973994']
2542,33269889,Face Pain scale and Borg scale compared to physiological parameters during cardiopulmonary exercise testing.,"OBJECTIVES
To investigate the differences between the Face Pain and Borg scales for rating of perceived exertion (RPE) during cardiopulmonary exercise testing (CPET) in healthy adults, and their relationships with work rate (watts), heart rate (HR), oxygen uptake (VO2), and minute ventilation (VE).
METHODS
In this prospective observational study, two experiments were conducted. In Experiment 1, 77 healthy adults were randomly assigned to either the group using the Face Pain scale (19 men, 18 women) or using the Borg scale (21 men, 19 women) for the RPE during CPET. In Experiment 2, 40 healthy adults (20 men, 20 women) used both the Face Pain and Borg scales for the RPE during CPET. In both experiments, CPET was performed on ramp protocols with incremental increases in the work rate by 20 watts/minute. Their responses in terms of watts, HR, VO2, VE, and RPE (assessed using the Face Pain scale or Borg scale) were recorded each minute.
RESULTS
There were significant relationships between the two scales and all physiological variables during CPET in 74 out of the 77 participants in Experiment 1 and in all subjects in Experiment 2 (p < 0.05). The correlation coefficient of the Face Pain scale with respect to the physi ological 1 parameters was slightly lower than that of Borg scale in both experiments (p < 0.05). The Face Pain scale had a significant correlation with the Borg scale during CPET in Experiment 2 (p < 0.05).
CONCLUSIONS
The Face Pain scale may be useful for determining the intensity of exercise in healthy adults, similar to the Borg scale.",2020,There were significant relationships between the two scales and all physiological variables during CPET in 74 out of the 77 participants in Experiment 1 and in all subjects in Experiment 2 (p < 0.05).,"['40 healthy adults (20 men, 20 women', '19 men, 18 women) or using the Borg scale (21 men, 19 women) for the RPE during CPET', '77 healthy adults', 'healthy adults']","['Face Pain scale', 'CPET', 'cardiopulmonary exercise testing (CPET']","['Face Pain scale', 'watts, HR, VO2, VE, and RPE (assessed using the Face Pain scale or Borg scale', 'work rate (watts), heart rate (HR), oxygen uptake (VO2), and minute ventilation (VE']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}]","[{'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439261', 'cui_str': 'watt'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}]",2.0,0.0193389,There were significant relationships between the two scales and all physiological variables during CPET in 74 out of the 77 participants in Experiment 1 and in all subjects in Experiment 2 (p < 0.05).,"[{'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Morishita', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan - ptmorishin@yahoo.co.jp.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Tsubaki', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Inoue', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Weixiang', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Kojima', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Jack B', 'Initials': 'JB', 'LastName': 'Fu', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, University of Texas, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Onishi', 'Affiliation': 'Institute for Human Movement and Medical Sciences, Niigata University of Health and Welfare, Niigata, Japan.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11815-2']
2543,33269876,Sprint interval training vs. combined aerobic+resistance training in overweight women with type 2 diabetes.,"BACKGROUND
Aerobic and resistance training have known efficacy for treating type2 diabetes (T2D). Less is known about interval training in this population. We examined the effects of sprint interval (SIT) and combined aerobic + resistance (COMB) training on HbA1C and (Primary Outcome) in participants with T2D. Secondary outcomes included HOMA-IR and standard clinical chemistries. Exploratory/Tertiary included immerging cardiovascular disease risk indices.
METHODS
Participants (N=52; 45-60y, BMI>30kg/m2, HbA1c, ≥6.5%) were randomly assigned to either SIT (n=17), COMB (n=17) or usual care control (Control, n=18) for 10-weeks. Data were analyzed by ANOVA and effect sizes estimated using Cohen's D (CD).
RESULTS
We observed significant reductions in HbA1c for SIT (-1.82%, 95% CI, -2.50, -1.14) and COMB (-1.24%, 95% CI, -2.19, -0.29), but not Control (0.02%, 95% CI, -0.67, 0.71). Secondary outcome analysis demonstrated significant reductions in HOMA-IR for SIT (-4.89, 95% CI, -6.94, - 2.83) and COMB training (-2.90, 95% CI, -5.00, -0.79), but not Control (-0.44, 95% CI, -3.44, 2.46). Effect size estimates and accompanying confidence interval bound were deemed ""large"" for HBA1c and moderate-to-large for HOMA-IR. Non-significant changes for the Control group were deemed ""trivial."" Both analyses were significant vs. Control. Similar patterns were observed for most standard laboratory measures and tertiary outcomes.
CONCLUSIONS
Our results demonstrate that SIT and COMBO training are effective exercise training regimens in overweight women with T2D independently of changes in body mass.",2020,"We observed significant reductions in HbA1c for SIT (-1.82%, 95% CI, -2.50, -1.14) and COMB (-1.24%, 95% CI, -2.19, -0.29), but not Control (0.02%, 95% CI, -0.67, 0.71).","['overweight women with type 2 diabetes', 'participants with T2D', 'overweight women with T2D independently of changes in body mass', 'Participants (N=52; 45-60y, BMI>30kg/m2, HbA1c, ≥6.5']","['SIT and COMBO training', 'COMB', 'usual care control', 'Sprint interval training vs. combined aerobic+resistance training', 'SIT', 'sprint interval (SIT) and combined aerobic + resistance (COMB) training', 'Aerobic and resistance training']","['HOMA-IR for SIT', 'COMB', 'HOMA-IR and standard clinical chemistries', 'cardiovascular disease risk indices', 'COMB training', 'Effect size estimates and accompanying confidence interval', 'HbA1c for SIT']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008000', 'cui_str': 'Clinical Chemistry'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.151442,"We observed significant reductions in HbA1c for SIT (-1.82%, 95% CI, -2.50, -1.14) and COMB (-1.24%, 95% CI, -2.19, -0.29), but not Control (0.02%, 95% CI, -0.67, 0.71).","[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mardaniyan Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran - majid.mardaniyan@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Department of Health and Kinesiology, Texas A&M University, College Station, TX, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11105-8']
2544,33269860,[Analysis of hemostatic effect of intra-articular injection of tranexamic acid after minimally invasive unicompartmental knee arthroplasty].,"OBJECTIVE
To investigate the effect of intra-articular injection of tranexamic acid on blood loss and blood transfusion rate after minimally invasive unicompartmental knee arthroplasty.
METHODS
From January 2015 to September 2017, 90 patients underwent minimally invasive unicompartmental knee arthroplasty were divided into tranexamic acid group and control group, 45 cases in each group. In the tranexamic acid group, there were 22 males and 23 females, aged 62 to 69 (66.1±2.4) years;in the control group, 20 males and 25 females, aged 63 to 71(68.5±5.2) years. The amount of bleeding in the drainage ball at 48 hours after operation was recorded, and the blood transfusion rate and hematocrit level duringthe perioperative period were recorded. The factors influencing perioperative blood loss included gender, age and body mass index (BMI).
RESULTS
All patients were followed up for 12.5 to 28.3 (22.8±7.9) months. During the follow-up, the wounds of the two groups healed well, and no deep vein thrombosis and pulmonary embolism occurred. There was no significant difference in postoperative blood loss between the tranexamic acid group and the control group. The postoperative bleeding volume in the tranexamic acid group was (110.0±52.1) ml, and that in the control group was (123.0±64.5) ml (P=0.39). There was no blood transfusion in the two groups.
CONCLUSION
Intra articular injection of tranexamic acid can not significantly reduce the postoperative blood loss in patients with minimally invasive unicompartment.",2020,"CONCLUSION
Intra articular injection of tranexamic acid can not significantly reduce the postoperative blood loss in patients with minimally invasive unicompartment.","['minimally invasive unicompartmental knee arthroplasty', '20 males and 25 females, aged 63 to 71(68.5±5.2) years', '22 males and 23 females, aged 62 to 69 (66.1±2.4', 'patients with minimally invasive unicompartment', 'From January 2015 to September 2017, 90 patients underwent minimally invasive unicompartmental knee arthroplasty']",['tranexamic acid'],"['blood loss and blood transfusion rate', 'deep vein thrombosis and pulmonary embolism', 'postoperative bleeding volume', 'blood transfusion', 'postoperative blood loss', 'blood transfusion rate and hematocrit level duringthe perioperative period']","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}]",,0.0302405,"CONCLUSION
Intra articular injection of tranexamic acid can not significantly reduce the postoperative blood loss in patients with minimally invasive unicompartment.","[{'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Wu', 'Affiliation': 'Kunshan Hospital of Traditional Chinese Medicine, Kunshan 215300, Jiangsu, China.'}, {'ForeName': 'Zi-Fei', 'Initials': 'ZF', 'LastName': 'Yin', 'Affiliation': 'Kunshan Hospital of Traditional Chinese Medicine, Kunshan 215300, Jiangsu, China.'}, {'ForeName': 'Bin-Feng', 'Initials': 'BF', 'LastName': 'Sun', 'Affiliation': 'Kunshan Hospital of Traditional Chinese Medicine, Kunshan 215300, Jiangsu, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Dong', 'Affiliation': 'Kunshan Hospital of Traditional Chinese Medicine, Kunshan 215300, Jiangsu, China.'}, {'ForeName': 'Ping-Kang', 'Initials': 'PK', 'LastName': 'Qian', 'Affiliation': 'Kunshan Hospital of Traditional Chinese Medicine, Kunshan 215300, Jiangsu, China.'}, {'ForeName': 'Jing-Bo', 'Initials': 'JB', 'LastName': 'Zhang', 'Affiliation': 'Kunshan Hospital of Traditional Chinese Medicine, Kunshan 215300, Jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Kunshan Hospital of Traditional Chinese Medicine, Kunshan 215300, Jiangsu, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.11.016']
2545,33269856,[Platelet-rich plasma combined with core decompression and bone grafting in the treatment of non traumatic necrosis of femoral head in ARCO stageⅡ].,"OBJECTIVE
To observe the clinical effect of platelet rich plasma (PRP) combined with β tricalcium phosphate bioceramic bone in the treatment of non traumatic necrosis of the femoral head in ARCO stageⅡ.
METHODS
From January 2017 to December 2018, 100 patients (160 hips) with ARCO stageⅡnon traumatic necrosis of the femoral head were divided into PRP group and control group. In PRP group, 50 patients (80 hips), 22 males and 28 females, aged from 18 to 65 (43.47± 7.23) years, with a course of 4 to 18 (15.8±2.9) months, underwent core decompression and bone grafting combined with PRP implantation. There were 50 cases (80 hips) in the control group, including 27 males and 23 females, aged 20 to 63 (45.72± 7.43) years, and the course of disease was 6 to 19 (14.9±3.8) months. Hip X-ay film was followed up after operation. Harris score and VAS score were used to evaluate the curative effect, and the survival rate of hip joint was recorded.
RESULTS
All patients had good wound healing, no infection, thrombosis and other complications. All patients were followed up for 12 to 14 (12.0±0.4) months. Twelve months after operation, the image expression of PRP group was better than that of control group( P <0.05). Harris hip score and VAS score of pain at twelve months after operation were 89.98±6.17 and 1.68±1.02 in PRP group and 81.62±5.62 and 2.52±1.13 in control group, respectively. The survival rate of 96.25% in PRP group was significantly higher than 86.25% in control group. The postoperative score of two groups was higher than that before operation( P <0.05), but PRP group was better than control group at any time point statistical significance ( P <0.05).
CONCLUSION
Platelet-rich plasma(PRP) combined with artificialbone for core decompression and bone grafting can change the situation of simple artificial bone implantation and uncertain curative effect, improve the success rate of this operation, effectively reduce the collapse rate of femoral head necrosis in the early and middle stage, delay or even avoid hip replacement.",2020,"The postoperative score of two groups was higher than that before operation( P <0.05), but PRP group was better than control group at any time point statistical significance ( P <0.05).
","['50 cases (80 hips) in the control group, including 27 males and 23 females, aged 20 to 63 (45.72± 7.43) years, and the course of disease was 6 to 19 (14.9±3.8) months', '50 patients (80 hips), 22 males and 28 females, aged from 18 to 65 (43.47± 7.23) years, with a course of 4 to 18 (15.8±2.9) months, underwent core decompression and bone grafting combined with PRP implantation', 'From January 2017 to December 2018, 100 patients (160 hips) with ARCO stageⅡnon traumatic necrosis of the femoral head were divided into PRP group and control group', 'non traumatic necrosis of femoral head in ARCO stageⅡ']","['Platelet-rich plasma combined with core decompression and bone grafting', 'platelet rich plasma (PRP) combined with β tricalcium phosphate bioceramic bone', 'Platelet-rich plasma(PRP) combined with artificialbone']","['postoperative score', 'Harris hip score and VAS score of pain', 'survival rate of hip joint', 'good wound healing, no infection, thrombosis and other complications', 'Harris score and VAS score', 'survival rate']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0444858', 'cui_str': 'AM 6'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C2743413', 'cui_str': 'ARCO'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0005976', 'cui_str': 'Bone graft'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C2712105', 'cui_str': 'Absence of signs and symptoms of infection'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0246487,"The postoperative score of two groups was higher than that before operation( P <0.05), but PRP group was better than control group at any time point statistical significance ( P <0.05).
","[{'ForeName': 'Dong-Dong', 'Initials': 'DD', 'LastName': 'Chen', 'Affiliation': ""Honghui Hospital Affiliated to Xi'an Jiaotong University, Xi'an 710000, Shaanxi, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': ""Honghui Hospital Affiliated to Xi'an Jiaotong University, Xi'an 710000, Shaanxi, China.""}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Yuwen', 'Affiliation': ""Honghui Hospital Affiliated to Xi'an Jiaotong University, Xi'an 710000, Shaanxi, China.""}, {'ForeName': 'Huan-Huan', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': ""Honghui Hospital Affiliated to Xi'an Jiaotong University, Xi'an 710000, Shaanxi, China.""}, {'ForeName': 'Qiu-Xia', 'Initials': 'QX', 'LastName': 'Wang', 'Affiliation': ""Honghui Hospital Affiliated to Xi'an Jiaotong University, Xi'an 710000, Shaanxi, China.""}, {'ForeName': 'Xue-Chao', 'Initials': 'XC', 'LastName': 'Yuan', 'Affiliation': ""Honghui Hospital Affiliated to Xi'an Jiaotong University, Xi'an 710000, Shaanxi, China.""}, {'ForeName': 'Yang-Quan', 'Initials': 'YQ', 'LastName': 'Hao', 'Affiliation': ""Honghui Hospital Affiliated to Xi'an Jiaotong University, Xi'an 710000, Shaanxi, China.""}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.11.012']
2546,33269854,[Efficacy and safety of tranexamic acid in total hip arthroplasty via direct anterior approach].,"OBJECTIVE
To evaluate the efficacy and safety of local application of tranexamic acid (TXA) in reducing perioperative blood loss in total hip arthroplasty via direct anterior approach (DAA).
METHODS
From July 2013 to September 2018, 46 patients with avascular necrosis of the femoral head were divided into tranexamic acid group ( n =23) and saline group ( n =23). In the tranexamic acid group, there were 14 males and 9 females, aged 52 to 72(63.70±5.34) years old. They were diluted with 3 g tranexamic acid in 50 ml normal saline and immersed in the joint cavity for 3 min after prosthesis replacement;in the normal saline group, there were 13 males and 10 females, aged 55 to 73 (61.26±5.78) years, who were treated with the sameamount of normal saline. The blood loss, hemoglobin value, number of blood transfusion cases, the time of first landing after operation, the incidence of thrombosis and incision adverse events were compared between the two groups. Harris score was used to evaluate hip joint function at 1 and 3 months after operation.
RESULTS
The incision healed well and no obvious complications occurred in the two groups. All patients were followed up for 12 to 59 months(averaged 31.11 months). No hip pain was found in the follow-up patients. Hip joint function was improved effectively and no prosthesis loosening occurred. The total perioperative blood loss in tranexamic acid group and normal saline group was(740.09±77.14) ml and (1 069.07±113.53) ml respectively, 24 hours after operation, the drainage volume was (87.61±9.28) ml, (233.83±25.62) ml, the hidden blood loss was (409.65±38.01) ml and (588.33±57.16) ml. the difference of hemoglobin before and after operation was (24.78±2.19) g / L and (33.57±2.95) g / L, the difference was statistically significant ( P <0.05). There was no significant difference in blood loss, incidence of deep vein thrombosis and pulmonary embolism, and Harris score of hip joint between the two groups ( P >0.05).
CONCLUSION
local application of tranexamic acid in total hip arthroplasty through direct anterior approach can safely and effectively reduce perioperative blood loss, and does not increase the risk of thrombosis, and does not affect the normal recovery of joint function.",2020,"There was no significant difference in blood loss, incidence of deep vein thrombosis and pulmonary embolism, and Harris score of hip joint between the two groups ( P >0.05).
","['14 males and 9 females, aged 52 to 72(63.70±5.34) years old', 'total hip arthroplasty via direct anterior approach', 'From July 2013 to September 2018, 46 patients with avascular necrosis of the femoral head', '13 males and 10 females, aged 55 to 73 (61.26±5.78) years, who were treated with the sameamount of normal saline', 'total hip arthroplasty via direct anterior approach (DAA']","['saline', 'tranexamic acid', 'tranexamic acid (TXA']","['blood loss, incidence of deep vein thrombosis and pulmonary embolism, and Harris score of hip joint', 'drainage volume', 'hip pain', 'perioperative blood loss', 'hidden blood loss', 'Hip joint function', 'total perioperative blood loss', 'hip joint function', 'incision healed well and no obvious complications', 'blood loss, hemoglobin value, number of blood transfusion cases, the time of first landing after operation, the incidence of thrombosis and incision adverse events']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410480', 'cui_str': 'Avascular necrosis of the head of femur'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",46.0,0.0548716,"There was no significant difference in blood loss, incidence of deep vein thrombosis and pulmonary embolism, and Harris score of hip joint between the two groups ( P >0.05).
","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopaedics, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou 310006, Zhejiang, China.'}, {'ForeName': 'Xiu-Juan', 'Initials': 'XJ', 'LastName': 'Qian', 'Affiliation': 'Department of Orthopaedics, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou 310006, Zhejiang, China.'}, {'ForeName': 'Yu-Peng', 'Initials': 'YP', 'LastName': 'Dong', 'Affiliation': 'Department of Orthopaedics, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou 310006, Zhejiang, China.'}, {'ForeName': 'Wei-Feng', 'Initials': 'WF', 'LastName': 'Ji', 'Affiliation': 'Department of Orthopaedics, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou 310006, Zhejiang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Department of Orthopaedics, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou 310006, Zhejiang, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.11.010']
2547,33269758,A network-based cognitive training induces cognitive improvements and neuroplastic changes in patients with relapsing-remitting multiple sclerosis: an exploratory case-control study.,"Cognitive impairments are commonly observed in patients with multiple sclerosis and are associated with lower levels of quality of life. No consensus has been reached on how to tackle effectively cognitive decline in this clinical population non-pharmacologically. This exploratory case-control study aims to investigate the effectiveness of a hypothesis-based cognitive training designed to target multiple domains by promoting the synchronous co-activation of different brain areas and thereby improve cognition and induce changes in functional connectivity in patients with relapsing-remitting multiple sclerosis. Forty-five patients (36 females and 9 males, mean age 44.62 ± 8.80 years) with clinically stable relapsing-remitting multiple sclerosis were assigned to either a standard cognitive training or to control groups (sham training and non-active control). The standard training included twenty sessions of computerized exercises involving various cognitive functions supported by distinct brain networks. The sham training was a modified version of the standard training that comprised the same exercises and number of sessions but with increased processing speed load. The non-active control group received no cognitive training. All patients underwent comprehensive neuropsychological and magnetic resonance imaging assessments at baseline and after 5 weeks. Cognitive and resting-state magnetic resonance imaging data were analyzed using repeated measures models. At reassessment, the standard training group showed significant cognitive improvements compared to both control groups in memory tasks not specifically targeted by the training: the Buschke Selective Reminding Test and the Semantic Fluency test. The standard training group showed reductions in functional connectivity of the salience network, in the anterior cingulate cortex, associated with improvements on the Buschke Selective Reminding Test. No changes were observed in the sham training group. These findings suggest that multi-domain training that stimulates multiple brain areas synchronously may improve cognition in people with relapsing-remitting multiple sclerosis if sufficient time to process training material is allowed. The associated reduction in functional connectivity of the salience network suggests that training-induced neuroplastic functional reorganization may be the mechanism supporting performance gains. This study was approved by the Regional Ethics Committee of Yorkshire and Humber (approval No. 12/YH/0474) on November 20, 2013.",2021,"The standard training group showed reductions in functional connectivity of the salience network, in the anterior cingulate cortex, associated with improvements on the Buschke Selective Reminding Test.","['people with relapsing-remitting multiple sclerosis', 'patients with multiple sclerosis', 'patients with relapsing-remitting multiple sclerosis', 'Forty-five patients (36 females and 9 males, mean age 44.62 ± 8.80 years) with clinically stable relapsing-remitting multiple sclerosis']","['computerized exercises involving various cognitive functions supported by distinct brain networks', 'no cognitive training', 'hypothesis-based cognitive training', 'standard cognitive training or to control groups (sham training and non-active control', 'network-based cognitive training']","['Buschke Selective Reminding Test and the Semantic Fluency test', 'functional connectivity of the salience network', 'quality of life', 'cognitive improvements', 'Cognitive impairments']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]",,0.0117963,"The standard training group showed reductions in functional connectivity of the salience network, in the anterior cingulate cortex, associated with improvements on the Buschke Selective Reminding Test.","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Manca', 'Affiliation': 'Department of Neuroscience, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Mitolo', 'Affiliation': 'Department of Neuroscience, University of Sheffield, Sheffield, UK; Istituto di Ricovero e Cura a Carattere Scientifico Istituto delle Scienze Neurologiche di Bologna, Diagnostica Funzionale Neuroradiologica, Bologna, Italy.'}, {'ForeName': 'Iain D', 'Initials': 'ID', 'LastName': 'Wilkinson', 'Affiliation': 'Academic Unit of Radiology, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paling', 'Affiliation': 'Department of Neuroscience, University of Sheffield; Academic Department of Neuroscience, Sheffield Teaching Hospital, National Health Service Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'Academic Department of Neuroscience, Sheffield Teaching Hospital, National Health Service Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Annalena', 'Initials': 'A', 'LastName': 'Venneri', 'Affiliation': 'Department of Neuroscience, University of Sheffield, Sheffield, UK.'}]",Neural regeneration research,['10.4103/1673-5374.300450']
2548,33269703,Effects of a Text Messaging Smoking Cessation Intervention Among Online Help Seekers and Primary Health Care Visitors in Sweden: Protocol for a Randomized Controlled Trial Using a Bayesian Group Sequential Design.,"BACKGROUND
A steady decline of the smoking prevalence in Sweden has been recorded over the past decade; however, people still start and continue to smoke. There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population.
OBJECTIVE
Previous randomized controlled trials of smoking cessation interventions among high school and university students in Sweden have found consistent evidence that text messaging interventions are effective in helping students quit smoking. However, there are no studies that investigate the effects of text messaging interventions in a more general population. The objective of this study is to estimate the effects of a text messaging intervention on individuals seeking help to quit online and individuals visiting primary health care units.
METHODS
A 2-arm, parallel-group (1:1), randomized controlled trial will be employed to address the study objectives. The trial will follow a Bayesian group sequential design. Recruitment will be conducted using online advertisement (Google, Bing, and Facebook) and through health care professionals at primary health care units. All participants will receive treatment as usual; however, participants who are allocated to the intervention arm will also be given access to a 12-week text message smoking cessation intervention. Primary outcomes are 8-week prolonged abstinence and 4-week point prevalence, measured 3 months and 6 months postrandomization. Mediator variables (self-efficacy, importance, and know-how) will be measured to estimate causal mediation models.
RESULTS
Recruitment commenced in September 2020 and will not exceed 24 months. This means that a complete dataset will be available at the latest towards the end of 2022. We expect to publish the findings from this trial by June 2023.
CONCLUSIONS
This trial will further our understanding of the effects of text messaging interventions among a more general population than has previously been studied. We also aim to learn about differential effects between those who seek support online and those who are given facilitated support at primary health care units. Trial recruitment is limited to the Swedish population; however, a strength of this study is the pragmatic way in which participants are recruited. Through online advertisements, individuals are recruited in reaction to their own interest in seeking help to quit. At primary health care units, individuals who were not necessarily looking for smoking cessation support are given information about the trial. This closely mimics the way the intervention would be disseminated in a real-world setting and may therefore strengthen the argument of generalizability of findings.
TRIAL REGISTRATION
ISRCTN 13455271; http://www.isrctn.com/ISRCTN13455271.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/23677.",2020,"There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population.
","['Online Help Seekers and Primary Health Care Visitors in Sweden', 'At primary health care units, individuals who were not necessarily looking for smoking cessation support are given information about the trial', 'high school and university students in Sweden', 'individuals seeking help to quit online and individuals visiting primary health care units']","['text messaging interventions', 'Text Messaging Smoking Cessation Intervention', 'smoking cessation interventions', 'text message smoking cessation intervention', 'text messaging intervention']",['8-week prolonged abstinence and 4-week point prevalence'],"[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1692317', 'cui_str': 'Smoking cessation assistance'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.148899,"There is a need for effective smoking cessation interventions that can scale to a national level and that are designed to reach individuals requiring smoking cessation support in the general population.
","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Linderoth', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}]",JMIR research protocols,['10.2196/23677']
2549,33269643,Omnidirectional camera and head-mount display contribute to the safety of laparoscopic surgery.,"BACKGROUND
We focused on the availability of an omnidirectional camera and head-mount display (HMD). If the laparoscope is an omnidirectional camera, captured images are sent to the HMD worn by the operator in real time. The operator can thus view the image as they like without moving the camera and obtain a 360° view intuitively. However, the surgical system that can be used for actual laparoscopic operations has not yet been developed. In this study, we aimed to show that an omnidirectional camera and HMD would be useful in laparoscopic surgery.
MATERIAL AND METHODS
Eleven medical students and twelve surgical residents (Surgeons group) participated in this study. We created an experimental box with five marks randomly attached inside the box, and the inside cannot be seen from the outside. We measured the time it took to identify all marks between conventional laparoscope and substitute system in each group.
RESULTS
In the substitute system, the time required for the task was significantly shorter than with conventional laparoscopy in each group.
CONCLUSION
An omnidirectional camera and HMD may be a useful new device for laparoscopic surgery. This system may help improve the safety of laparoscopic surgery.",2020,"In the substitute system, the time required for the task was significantly shorter than with conventional laparoscopy in each group.
",['Eleven medical students and twelve surgical residents (Surgeons group) participated in this study'],"['omnidirectional camera and HMD', 'laparoscopic surgery', 'conventional laparoscopy']",['time required for the task'],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C5197728', 'cui_str': 'Head Worn Display'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}]",11.0,0.0396341,"In the substitute system, the time required for the task was significantly shorter than with conventional laparoscopy in each group.
","[{'ForeName': 'Shoichiro', 'Initials': 'S', 'LastName': 'Mukai', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Egi', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Hattori', 'Affiliation': 'Center for Medical Education Graduate School of Biomedical Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Sumi', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kurita', 'Affiliation': 'Department of Artificial Complex Systems Engineering, Graduate School of Engineering, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ohdan', 'Affiliation': 'Department of Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}]",Minimally invasive therapy & allied technologies : MITAT : official journal of the Society for Minimally Invasive Therapy,['10.1080/13645706.2020.1851725']
2550,33269632,The effect of varus stem placement on joint offset during total hip arthroplasty: a virtual study.,"INTRODUCTION AND AIMS
With total hip replacement (THR), varus alignment of an uncemented stem will increase offset which can have significant detrimental effects on muscular balance, leg length and overall satisfaction. Thus, we used 3D planning software to determine the change in joint offset with increasing varus stem placement.
METHODS
Eight patients undergoing THR had routine computed tomography (CT) scans to allow for 3D hip planning. Each set of CTs was templated with a straight stem and an uncemented acetabular cup. Initial templating was performed to reproduce native leg length and offset. The templated stem was then rotated into varus at 1° intervals, up to 6° varus while offset changes for all varus positions were noted. This was repeated for each of 3 neck angles, 125°, 135° and 135° lateral and for each stem sizes 1, 3, 5 and 7.
RESULTS
Overall, there was a mean 1.5 mm increase in offset for every 1° of varus. The stems with a 125° neck angle had the greatest increase in mean offset at 1.6 mm for every 1° of varus. The stem neck angles of 135° lateral offset and 135° standard offset, had a mean increase in offset of 1.5 mm and 1.4 mm respectively for every 1° of varus. A greater mean increase in offset for every 1° of varus was observed with increasing stem size.
CONCLUSIONS
We have quantified the relationship between alignment and offset with every 1° of varus placement increasing hip offset for straight stems by 1.5 mm. This can be used as a guide for surgeons during THR so that they have a better quantitative understanding of how varus placement of the stem affects the hip offset.",2020,The stems with a 125° neck angle had the greatest increase in mean offset at 1.6 mm for every 1° of varus.,"['Eight patients undergoing THR had routine computed tomography (CT) scans to allow for 3D hip planning', 'total hip arthroplasty']","['total hip replacement (THR', 'varus stem placement']","['muscular balance, leg length and overall satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0426952', 'cui_str': 'Leg length'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",8.0,0.0240376,The stems with a 125° neck angle had the greatest increase in mean offset at 1.6 mm for every 1° of varus.,"[{'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Sydney Medical School, University of Sydney, NSW, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Pierrepont', 'Affiliation': 'Corin Group, Pymble, NSW, Australia.'}, {'ForeName': 'Chameka', 'Initials': 'C', 'LastName': 'Madurawe', 'Affiliation': 'Corin Group, Pymble, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Shimmin', 'Affiliation': 'Corin Group, Pymble, NSW, Australia.'}, {'ForeName': 'Warwick', 'Initials': 'W', 'LastName': 'Bruce', 'Affiliation': 'Sydney Medical School, University of Sydney, NSW, Australia.'}]",Hip international : the journal of clinical and experimental research on hip pathology and therapy,['10.1177/1120700020978368']
2551,33269529,"Intradermal injections with 0.5% minoxidil for the treatment of female androgenetic alopecia: a randomized, placebo-controlled trial.","BACKGROUND
Female androgenetic alopecia is one cause of alopecia in women, although the ideal treatment for this condition remains far from defined. The objective of this study was to evaluate the efficacy and safety of intradermal injections with 0.5% minoxidil for the management of female androgenetic alopecia in a randomized, placebo-controlled trial.
METHODS
A total of 54 women diagnosed with female androgenetic alopecia were divided into two groups: one group received intradermal injections of 0.5% minoxidil, and the other received 0.9% saline. Biopsy, trichogram, Trichoscan® (Tricholog GmbH, Freiburg, Germany), and self-assessment findings were used to evaluate the outcomes of treatment with minoxidil.
RESULTS
In the treated group, there was a significant increase in the terminal-to-vellus hair ratio (P < 0.001) and in the percentage of anagen hairs (P = 0.048) and an improvement in hair loss and volume (P = 0.021 and P = 0.028, respectively).
CONCLUSIONS
These results show that intradermal injections with minoxidil were more effective than placebo (P < 0.001) in the treatment of female androgenetic alopecia with a good safety profile. This article is protected by copyright. All rights reserved.",2020,These results show that intradermal injections with minoxidil were more effective than placebo (P < 0.001) in the treatment of female androgenetic alopecia with a good safety profile.,"['female androgenetic alopecia', '54 women diagnosed with female androgenetic alopecia']","['intradermal injections with 0.5% minoxidil', 'placebo', 'Intradermal injections with 0.5% minoxidil', 'minoxidil', 'intradermal injections of 0.5% minoxidil, and the other received 0.9% saline']","['percentage of anagen hairs', 'efficacy and safety', 'terminal-to-vellus hair ratio', 'hair loss and volume']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0162311', 'cui_str': 'Alopecia hereditaria'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0221976', 'cui_str': 'Anagen hair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0221959', 'cui_str': 'Structure of vellus hair'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",54.0,0.0543472,These results show that intradermal injections with minoxidil were more effective than placebo (P < 0.001) in the treatment of female androgenetic alopecia with a good safety profile.,"[{'ForeName': 'Bárbara Pontes Cerqueira', 'Initials': 'BPC', 'LastName': 'Uzel', 'Affiliation': 'Private Dermatology Service, Taguatinga, DF, Brazil.'}, {'ForeName': 'Gustavo Henrique Soares', 'Initials': 'GHS', 'LastName': 'Takano', 'Affiliation': 'Pathology Department, University of Brasília (UNB), Brasília, DF, Brazil.'}, {'ForeName': 'Juliana Cabral Nunes', 'Initials': 'JCN', 'LastName': 'Chartuni', 'Affiliation': 'Private Dermatology Service, Águas Claras, DF, Brazil.'}, {'ForeName': 'Mariana Vicente', 'Initials': 'MV', 'LastName': 'Cesetti', 'Affiliation': 'Dermatology Department, University of Brasília (UNB), Brasília, DF, Brazil.'}, {'ForeName': 'Camila Fátima Biancardi', 'Initials': 'CFB', 'LastName': 'Gavioli', 'Affiliation': 'Dermatology Department, University of São Paulo (USP), SP, Brazil.'}, {'ForeName': 'André Moreira', 'Initials': 'AM', 'LastName': 'Lemes', 'Affiliation': 'Private Dermatology Service, Águas Claras, DF, Brazil.'}, {'ForeName': 'Izelda Maria Carvalho', 'Initials': 'IMC', 'LastName': 'Costa', 'Affiliation': 'Dermatology Department, University of Brasília (UNB), Brasília, DF, Brazil.'}]",Dermatologic therapy,['10.1111/dth.14622']
2552,33269509,Flash Glucose Monitoring Data Analyzed by Detrended Fluctuation Function on β Cell Function and Diabetes Classification.,"We aimed to use data-driven glucose pattern analysis to unveil the correlation between the metrics reflecting glucose fluctuation and β cell function, and also to identify possible role of this metric in diabetes classification. 78 type 1 diabetes and 59 type 2 diabetes participants were enrolled in this study. All participants wore Flash Glucose Monitoring (FGM) and glucose data were collected. A detrended fluctuation function (DFF) was utilized to extract glucose fluctuation information from FGM data and a DFF-based glucose fluctuation metric was proposed. For the entire study population, a significant negative correlation between the DFF-based glucose fluctuation metric and fasting C-peptide was observed (r = -0.667; P < 0.001), which was larger than the correlation coefficient between the fasting C-peptide and Mean Amplitude of Plasma Glucose Excursions (MAGE) (r = -0.639; P < 0.001), Standard Deviation (SD) (r = -0.649; P < 0.001), Mean Blood Glucose (BG) (r = -0.519; P < 0.001), and Time in Range (TIR) (r = 0.593; P < 0.001). Since glucose data analyzed by DFF revealed a clear bimodal distribution among the total participants, we randomly assigned the 137 participants into discovery cohorts (n=100) and validation cohorts (n=37) for 10 times to evaluate the consistency and effectiveness of the proposed metric for diabetes classification. The confidence interval (CI) for area under the curve (AUC) according to the Receiver Operating Characteristic (ROC) analysis in the 10 discovery cohorts achieved [0.846, 0.868] and that for the 10 validation cohorts was [0.799, 0.862]. In addition, the CI for sensitivity and specificity in the discovery cohorts were [75.5%, 83.0%], [81.3%, 88.5%] and [71.8%, 88.3%], [76.5%, 90.3%] in the validation cohorts, indicating the potential capacity of DFF in distinguishing type 1 and type 2 diabetes. Our study first proposed the possible role of data-driven analysis acquired glucose metric in predicting β cell function and diabetes classification, and large scale, multi-center study will be needed in the future. The dataset we are building now include data from newly diagnosed diabetes participants, and we are planning to test the performance of DFF in this specific population. This article is protected by copyright. All rights reserved.",2020,"For the entire study population, a significant negative correlation between the DFF-based glucose fluctuation metric and fasting C-peptide was observed (r = -0.667; P < 0.001), which was larger than the correlation coefficient between the fasting C-peptide and Mean Amplitude of Plasma Glucose Excursions (MAGE) (r = -0.639; P < 0.001), Standard Deviation (SD) (r = -0.649; P < 0.001), Mean Blood Glucose (BG) (r = -0.519; P < 0.001), and Time in Range (TIR) (r = 0.593; P < 0.001).","['78 type 1 diabetes and 59 type 2 diabetes participants', 'newly diagnosed diabetes participants', '137 participants into discovery cohorts (n=100) and validation cohorts (n=37']",[],"['Time in Range (TIR', 'sensitivity and specificity', 'Flash Glucose Monitoring (FGM) and glucose data', 'fasting C-peptide and Mean Amplitude of Plasma Glucose Excursions (MAGE', 'Mean Blood Glucose (BG', 'potential capacity of DFF', 'confidence interval (CI) for area under the curve (AUC', 'DFF-based glucose fluctuation metric and fasting C-peptide']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0574173', 'cui_str': 'Tigrinya language'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",137.0,0.0413881,"For the entire study population, a significant negative correlation between the DFF-based glucose fluctuation metric and fasting C-peptide was observed (r = -0.667; P < 0.001), which was larger than the correlation coefficient between the fasting C-peptide and Mean Amplitude of Plasma Glucose Excursions (MAGE) (r = -0.639; P < 0.001), Standard Deviation (SD) (r = -0.649; P < 0.001), Mean Blood Glucose (BG) (r = -0.519; P < 0.001), and Time in Range (TIR) (r = 0.593; P < 0.001).","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, PR China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, PR China.'}, {'ForeName': 'Luxi', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, PR China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, PR China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, PR China.""}, {'ForeName': 'Siqian', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, PR China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, PR China.'}, {'ForeName': 'Junzheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, PR China.'}, {'ForeName': 'Xueyao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, PR China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'School of Automation, Beijing Institute of Technology, Beijing, PR China.'}, {'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, PR China.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14282']
2553,33269487,Evaluation of effect of scheduled fresh frozen plasma on ECMO circuit life: A randomized pilot trial.,"BACKGROUND
Factor consumption is common during ECMO complicating the balance of pro and anticoagulation factors. This study sought to determine whether transfusion of coagulation factors using fresh frozen plasma (FFP) increased ECMO circuit life and decreased blood product transfusion. Secondly, it analyzed the association between FFP transfusion and hemorrhagic and thrombotic complications.
STUDY DESIGN AND METHODS
Thirty-one pediatric ECMO patients between October 2013 and January 2016 at a quaternary care institution were included. Patients were randomized to FFP every 48 hours or usual care. The primary outcome was ECMO circuit change. Secondary outcomes included blood product transfusion, survival to decannulation, hemorrhagic and thrombotic complications, and ECMO costs.
RESULTS
Median (interquartile range [IQR]) number of circuit changes was 0 (0, 1). No difference was seen in percent days without a circuit change between intervention and control group, P = .53. Intervention group patients received median platelets of 15.5 mL/kg/d IQR (3.7, 26.8) vs 24.8 mL/kg/d (12.2, 30.8) for the control group (P = .16), and median packed red blood cells (pRBC) of 7.7 mL/kg/d (3.3, 16.3) vs 5.9 mL/kg/d (3.4, 18.7) for the control group, P = .60. FFP transfusions were similar with 10.2 mL/kg/d (5.0, 13.9) in the intervention group vs 8.8 (2.5, 17.7) for the control group, P = .98.
CONCLUSION
In this pilot randomized study, scheduled FFP did not increase circuit life. There was no difference in blood product transfusion of platelets, pRBCs, and FFP between groups. Further studies are needed to examine the association of scheduled FFP with blood product transfusion.",2020,"No difference was seen in percent days without a circuit change between intervention and control group, P = .53.",['Thirty-one pediatric ECMO patients between October 2013 and January 2016 at a quaternary care institution were included'],"['FFP', 'scheduled fresh frozen plasma']","['FFP transfusion and hemorrhagic and thrombotic complications', 'number of circuit changes', 'circuit change', 'ECMO circuit life and decreased blood product transfusion', 'median platelets', 'ECMO circuit change', 'median packed red blood cells (pRBC', 'FFP transfusions', 'Median (interquartile range [IQR', 'ECMO circuit life', 'blood product transfusion of platelets, pRBCs, and FFP', 'circuit life', 'blood product transfusion, survival to decannulation, hemorrhagic and thrombotic complications, and ECMO costs']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C1293883', 'cui_str': 'Transfusion of fresh frozen plasma'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0178148', 'cui_str': 'Removal of tracheostomy tube'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",31.0,0.147844,"No difference was seen in percent days without a circuit change between intervention and control group, P = .53.","[{'ForeName': 'Ali B V', 'Initials': 'ABV', 'LastName': 'McMichael', 'Affiliation': 'UT Southwestern, Department of Pediatrics, Division of Critical Care, Dallas, Texas, USA.'}, {'ForeName': 'Kanecia O', 'Initials': 'KO', 'LastName': 'Zimmerman', 'Affiliation': 'Duke University Hospital, Department of Pediatrics, Division of Critical Care, Durham, North Carolina, USA.'}, {'ForeName': 'Karan R', 'Initials': 'KR', 'LastName': 'Kumar', 'Affiliation': 'Duke University Hospital, Department of Pediatrics, Division of Critical Care, Durham, North Carolina, USA.'}, {'ForeName': 'Caroline P', 'Initials': 'CP', 'LastName': 'Ozment', 'Affiliation': 'Duke University Hospital, Department of Pediatrics, Division of Critical Care, Durham, North Carolina, USA.'}]",Transfusion,['10.1111/trf.16164']
2554,33269486,Relationship between baseline cardiac biomarkers and cardiovascular death or hospitalization for heart failure with and without SGLT2 inhibitor therapy in DECLARE-TIMI 58.,"AIMS
Dapagliflozin reduced the risk of the composite of cardiovascular death or hospitalization for heart failure (CV death/HHF) in patients with type 2 diabetes (T2DM) in DECLARE-TIMI 58. We hypothesized that baseline NT-proBNP and hsTnT levels would help identify patients who are at higher baseline risk and we describe the treatment effects of dapagliflozin in patients according to their baseline NT-proBNP and hsTnT levels.
METHODS AND RESULTS
This was a prespecified biomarker study from DECLARE-TIMI 58, a randomized, double-blind, placebo-controlled CV outcomes trial of dapagliflozin. Baseline NT-proBNP and hsTnT levels were measured in the TIMI Clinical Trials Laboratory in 14 565 patients. Among the included patients, 9143 patients (62.8%) were male, 1464 (10.1%) had a history of HF and the mean age was 63.9. The median baseline NT-proBNP and hsTnT levels were 75 pg/mL (IQR 35-165) and 10.2 pg/mL (IQR 6.9-15.5), respectively. Patients with higher NT-proBNP and hsTnT quartiles had higher rates of CV death/HHF (Q4 vs Q1: NT-proBNP: 4-year KM event rates 13.7% vs 1.0%; hsTnT: 11.8% vs 1.4%; P-trend <0.001). Dapagliflozin consistently reduced the relative risk of CV death/HHF regardless of baseline NT-proBNP (P-interaction 0.72) or hsTnT quartiles (P-interaction 0.93). Given their higher baseline risk, patients with NT-proBNP and/or hsTnT levels above the median derived larger absolute risk reductions with dapagliflozin (NT-proBNP 1.9%; vs. 0%, P-interaction 0.010; hsTnT 1.8% vs 0.1%, P-interaction 0.026).
CONCLUSION
Patients with T2DM and higher NT-proBNP or hsTnT levels are at increased risk of CV death and HHF. Dapagliflozin reduced the relative risk of CV death/HHF irrespective of NT-proBNP and hsTnT levels, with greater absolute risk reductions seen in patients with higher baseline biomarker levels.",2020,"Dapagliflozin reduced the relative risk of CV death/HHF irrespective of NT-proBNP and hsTnT levels, with greater absolute risk reductions seen in patients with higher baseline biomarker levels.","['included patients, 9143 patients (62.8%) were male, 1464 (10.1%) had a history of HF and the mean age was 63.9', 'patients with type 2 diabetes (T2DM) in DECLARE-TIMI 58']","['Dapagliflozin', 'dapagliflozin', 'placebo', 'SGLT2 inhibitor therapy', 'NT-proBNP']","['risk of CV death and HHF', 'risk of the composite of cardiovascular death or hospitalization for heart failure (CV death/HHF', 'median baseline NT-proBNP and hsTnT levels', 'rates of CV death/HHF', 'Baseline NT-proBNP and hsTnT levels', 'relative risk of CV death/HHF irrespective of NT-proBNP and hsTnT levels', 'relative risk of CV death/HHF regardless of baseline NT-proBNP']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",14565.0,0.393841,"Dapagliflozin reduced the relative risk of CV death/HHF irrespective of NT-proBNP and hsTnT levels, with greater absolute risk reductions seen in patients with higher baseline biomarker levels.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': 'Division of Cardiology, Medical University of Vienna, Austria.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital and Harvard Medical School.""}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'Department of Cardiology and Angiology I, Heart Center Freiburg University, Faculty of Medicine, University of Freiburg, Freiburg, 79106, Germany.'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Lady Davis Carmel Medical Center and the Technion-Israel Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Gause-Nilsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'The Diabetes Unit, Department of Endocrinology and Metabolism, Hadassah Medical Center, Hebrew University of Jerusalem, The Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.""}]",European journal of heart failure,['10.1002/ejhf.2073']
2555,33272026,Lasting Effects of a Community-Based Self-Management Intervention for Patients With Type 2 Diabetes in China: Outcomes at 2-Year Follow-up of a Randomized Trial.,"This research is to evaluate the lasting effects of a community-based self-management intervention for patients with type 2 diabetes at 2-year follow-up in China. Five hundred patients with diabetes were recruited and randomly divided into intervention group and control group. Eight times standardized self-management intervention group activities were conducted. The results of physical examination, biochemical laboratory examination, health behavior, and self-efficacy information were collected before intervention, 3 months after intervention, and 2 years after intervention. The total score for self-efficacy in the intervention group increased from 96.12 ± 17.48 to 112.90 ± 14.58 after intervention and decreased after 2 years (106.98 ± 18.03; F = 6.64, P = .0014). The number of days of self-blood glucose monitoring in the intervention group was increased from 1 day per week to 2 days per week after intervention, and 2 days per week at 2-year follow-up ( F = 8.02, P = .0003). The frequency of average number of aerobic exercises in the intervention group increased from 6 days per week to 7 days per week after intervention and was 7 days per week at 2-year follow-up ( F = 3.63, P = .0269). Community-based self-management group intervention for patients with diabetes has long-term effects.",2020,"The frequency of average number of aerobic exercises in the intervention group increased from 6 days per week to 7 days per week after intervention and was 7 days per week at 2-year follow-up ( F = 3.63, P = .0269).","['patients with diabetes', 'patients with type 2 diabetes at 2-year follow-up in China', 'Patients With Type 2 Diabetes in China', 'Five hundred patients with diabetes']","['Community-based self-management group intervention', 'community-based self-management intervention', 'Community-Based Self-Management Intervention']","['frequency of average number of aerobic exercises', 'total score for self-efficacy', 'number of days of self-blood glucose monitoring', 'physical examination, biochemical laboratory examination, health behavior, and self-efficacy information']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",500.0,0.024296,"The frequency of average number of aerobic exercises in the intervention group increased from 6 days per week to 7 days per week after intervention and was 7 days per week at 2-year follow-up ( F = 3.63, P = .0269).","[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Mao', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlan', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Xingxing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Beijing Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Jianqun', 'Initials': 'J', 'LastName': 'Dong', 'Affiliation': 'National Center for Chronic and Noncommunicable Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}]",Asia-Pacific journal of public health,['10.1177/1010539520975266']
2556,33272025,Home-based exercise monitored with telehealth is feasible and acceptable compared to centre-based exercise in Parkinson's disease: A randomised pilot study.,"OBJECTIVES
To investigate the feasibility and acceptability of a home-based exercise program monitored using telehealth for people with Parkinson's disease.
DESIGN
Pilot randomised control trial.
SETTING
University physiotherapy clinic, participants' homes.
PARTICIPANTS
Forty people with mild to moderate Parkinson's disease, mean age 72 (6.9).
INTERVENTION
In Block 1 (5 weeks) all participants completed predominantly centre-based exercise plus a self-management program. Participants were then randomised to continue the centre-based exercise ( n = 20) or to a home-based program with telehealth ( n = 20) for Block 2 (5 weeks). The exercises targeted balance and gait.
OUTCOMES
The primary outcomes were the feasibility and acceptability of the intervention. Secondary outcomes were balance, gait speed and freezing of gait.
RESULTS
Adherence was high in Block 1 (93%), and Block 2 (centre-based group = 93%, home-based group = 84%). In Block 2, the physiotherapist spent 6.4 hours providing telehealth to the home-based group (mean 10 (4) minutes per participant) and 32.5 hours delivering the centre-based exercise classes (98 minutes per participant). Participants reported that exercise was helpful, they could follow the home program and they would recommend exercising at home or in a group. However, exercising at home was less satisfying and there was a mixed response to the acceptability of the self-management program. There was no difference between groups in any of the secondary outcome measures (preferred walking speed mean difference -0.04 (95% CI: -0.12 to 0.05).
CONCLUSION
Home-based exercise monitored using telehealth for people with Parkinson's disease is feasible and acceptable.",2020,There was no difference between groups in any of the secondary outcome measures (preferred walking speed mean difference,"[""Forty people with mild to moderate Parkinson's disease, mean age 72 (6.9"", ""University physiotherapy clinic, participants' homes"", ""people with Parkinson's disease""]","['centre-based exercise plus a self-management program', 'Home-based exercise monitored with telehealth', 'home-based exercise program monitored using telehealth', 'centre-based exercise ( n \u2009=\u200920) or to a home-based program with telehealth', 'Home-based exercise monitored using telehealth']","['feasibility and acceptability of the intervention', 'balance, gait speed and freezing of gait', 'Adherence']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",40.0,0.090454,There was no difference between groups in any of the secondary outcome measures (preferred walking speed mean difference,"[{'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Flynn', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, NSW, Australia.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Preston', 'Affiliation': 'Discipline of Physiotherapy, Faculty of Health, University of Canberra, Bruce, ACT, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dennis', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, NSW, Australia.'}, {'ForeName': 'Colleen G', 'Initials': 'CG', 'LastName': 'Canning', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, NSW, Australia.'}, {'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Allen', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, NSW, Australia.'}]",Clinical rehabilitation,['10.1177/0269215520976265']
2557,33271975,A Pilot Study of a Psychoeducational Group Intervention Delivered at Asylum Accommodation Centers-A Mixed Methods Approach.,"Asylum seekers suffer high levels of distress but have restricted access to mental health care. This paper constitutes an evaluation of a psycho-educational group intervention, called AMIN, which was provided at two asylum accommodation centers in Sweden. A mixed-methods approach was used. To assess potential effectiveness, acceptability, and feasibility, quantitative outcome measures were combined with qualitative information from interviews with both intervention participants and staff providing the intervention. Potential effectiveness in reducing symptoms of distress and insomnia and in increasing physical quality of life was found, even though the intervention participants suffered from more severe distress than expected. In general, the intervention seemed to be acceptable to both participants and staff, with concrete strategies seeming more meaningful than abstract psychological techniques. Finally, regardless of the asylum process itself being a complicating factor, the intervention seemed feasible to deliver to individuals with different backgrounds and conditions. Taken together, these results indicate that some sessions may need further elaboration, but also that the transition to a randomized control trial is reasonable.",2020,"Potential effectiveness in reducing symptoms of distress and insomnia and in increasing physical quality of life was found, even though the intervention participants suffered from more severe distress than expected.",[],['Psychoeducational Group Intervention Delivered at Asylum Accommodation Centers-A Mixed Methods Approach'],"['severe distress', 'potential effectiveness, acceptability, and feasibility, quantitative outcome measures', 'physical quality of life']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0467071,"Potential effectiveness in reducing symptoms of distress and insomnia and in increasing physical quality of life was found, even though the intervention participants suffered from more severe distress than expected.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Leiler', 'Affiliation': 'Institution of Psychology and Social Work, Mid Sweden University, 831 25 Östersund, Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Wasteson', 'Affiliation': 'Institution of Psychology and Social Work, Mid Sweden University, 831 25 Östersund, Sweden.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Holmberg', 'Affiliation': 'Institution of Psychology and Social Work, Mid Sweden University, 831 25 Östersund, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bjärtå', 'Affiliation': 'Institution of Psychology and Social Work, Mid Sweden University, 831 25 Östersund, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17238953']
2558,33271891,Effect of Comprehensive Interventions Including Nutrition Education and Physical Activity on High Blood Pressure among Children: Evidence from School-Based Cluster Randomized Control Trial in China.,"Childhood hypertension has increasingly become a public health problem globally. However, limited literature research examined the effect of comprehensive interventions including nutrition education and physical activity on blood pressure among children. A total of 6764 children aged 7-13 years were analyzed based on a multicenter randomized controlled trial for comprehensive interventions in 30 primary schools in China to evaluate the effects on blood pressure, which lasted for two semesters. The standards used for the diagnosis of high blood pressure were the cut-off points based on age and sex for Chinese children. Compared with the control group, the intervention effects were -0.5 mm Hg (95% confidence interval (CI): -1.1, 0; p = 0.064) for diastolic blood pressure and -0.9 mmHg (95% CI: -1.5, -0.3; p = 0.005) for systolic blood pressure. For the incidence of high blood pressure, the changes were -1.4% in the intervention group and 0.4% in the control group (1.8% difference between the two groups, p = 0.015) after trial. The school-based comprehensive interventions appeared to have moderate effects on high blood pressure prevention among children in China.",2020,"Compared with the control group, the intervention effects were -0.5 mm","['children', 'Children: Evidence from School-Based Cluster Randomized Control Trial in China', 'children in China', '30 primary schools in China', '6764 children aged 7-13 years']",['Comprehensive Interventions Including Nutrition Education and Physical Activity'],"['high blood pressure', 'diastolic blood pressure', 'systolic blood pressure', 'blood pressure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",6764.0,0.0478904,"Compared with the control group, the intervention effects were -0.5 mm","[{'ForeName': 'Haiquan', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Food and Nutrition Development, Ministry of Agriculture and Rural Affairs, Beijing 100081, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard T. H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Xianwen', 'Initials': 'X', 'LastName': 'Shang', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, East Melbourne, VIC 3002, Australia.'}, {'ForeName': 'Songming', 'Initials': 'S', 'LastName': 'Du', 'Affiliation': 'Chinese Nutrition Society, Beijing 100022, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Centre for Disease Control and Prevention, Beijing 100050, China.'}, {'ForeName': 'Ailing', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'National Institute for Nutrition and Health, Chinese Centre for Disease Control and Prevention, Beijing 100050, China.'}, {'ForeName': 'Guansheng', 'Initials': 'G', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition and Food Hygiene, School of Public Health, Peking University, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17238944']
2559,33270806,Training outcomes for audiology students using virtual reality or traditional training methods.,"Due to limited space and resources, it can be difficult to train students on audiological procedures adequately. In the present study, we compared audiology training outcomes between a traditional approach and a recently developed immersive virtual reality (VR) approach in audiology students. Twenty-nine first-year audiology students participated in the study; 14 received traditional training (""TT group""), and 15 received the VR training (""VRT group""). Pre- and post-training evaluation included a 20-item test developed by an audiology educator. Post-training satisfaction and self-confidence were evaluated using Likert scales. Mean post-training test scores improved by 6.9±9.8 percentage points in the TT group and by 21.1±7.8 points in the VRT group; the improvement in scores was significant for both groups. After completing the traditional training, the TT group was subsequently trained with the VR system, after which mean scores further improved by 7.5 points; there was no significant difference in post-VR training scores between the TT and VRT groups. After training, the TT and VRT groups completed satisfaction and self-confidence questionnaires. Satisfaction and self-confidence ratings were significantly higher for the VR training group, compared to the traditional training group. Satisfaction ratings were ""good"" (4 on Likert scale) for 74% of the TT group and 100% of the VRT group. Self-confidence ratings were ""good"" for 71% of the TT group and 92% of the VRT group. These results suggest that a VR training approach may be an effective alternative or supplement to traditional training for audiology students.",2020,"Self-confidence ratings were ""good"" for 71% of the TT group and 92% of the VRT group.","['Twenty-nine first-year audiology students participated in the study; 14 received', 'in audiology students']","['VRT', 'traditional training (""TT group', 'VR training', 'virtual reality or traditional training methods', 'VR training (""VRT group', 'traditional approach and a recently developed immersive virtual reality (VR) approach', 'TT and VRT']","['Satisfaction ratings', 'satisfaction and self-confidence questionnaires', 'Self-confidence ratings', 'Satisfaction and self-confidence ratings', 'Mean post-training test scores', 'post-VR training scores']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004285', 'cui_str': 'Audiology'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]",,0.0136698,"Self-confidence ratings were ""good"" for 71% of the TT group and 92% of the VRT group.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bakhos', 'Affiliation': 'CHU de Tours, service ORL et Chirurgie Cervico-Faciale, Tours, France.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Galvin', 'Affiliation': 'INSERM UMR 1253 I-brain, Université François-Rabelais de Tours, CHRU de Tours, Tours, France.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Aoustin', 'Affiliation': 'CHU de Tours, service ORL et Chirurgie Cervico-Faciale, Tours, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Robier', 'Affiliation': 'CHU de Tours, service ORL et Chirurgie Cervico-Faciale, Tours, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Kerneis', 'Affiliation': 'CHU de Tours, service ORL et Chirurgie Cervico-Faciale, Tours, France.'}, {'ForeName': 'Garance', 'Initials': 'G', 'LastName': 'Bechet', 'Affiliation': ""Ecole d'audioprothèse JE Bertin, Université de Rennes 1, Javene, France.""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Montembault', 'Affiliation': ""Ecole d'audioprothèse JE Bertin, Université de Rennes 1, Javene, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': ""Ecole d'audioprothèse JE Bertin, Université de Rennes 1, Javene, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Godey', 'Affiliation': ""Ecole d'audioprothèse JE Bertin, Université de Rennes 1, Javene, France.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Aussedat', 'Affiliation': 'CHU de Tours, service ORL et Chirurgie Cervico-Faciale, Tours, France.'}]",PloS one,['10.1371/journal.pone.0243380']
2560,33270718,Skill retention with ultrasound curricula.,"BACKGROUND
Implementation of a point of care ultrasound curricula is valuable, but optimal integration for internal medicine residency is unclear. The purpose of this study was to evaluate if a structured ultrasound curriculum vs. structured ultrasound curriculum plus supervised thoracic ultrasounds would improve internal medicine residents' skill and retention 6 and 12 months from baseline.
METHODS
We conducted a randomized controlled study evaluating internal medical residents' skill retention of thoracic ultrasound using a structured curriculum (control, n = 14) vs. structured curriculum plus 20 supervised bedside thoracic ultrasounds (intervention, n = 14). We used a stratified randomization based on program year. All subjects attended a half-day course that included 5 lectures and hands-on sessions at baseline. Assessments included written and practical exams at baseline, immediately post-course and at 6 and 12 months. Scores are reported as a percentage for the number of correct responses/number of questions (range 0-100%). The Mann Whitney U and the Friedman tests were used for analyses.
RESULTS
Twenty-eight residents were enrolled. Two subjects withdrew prior to the 6-month exams. Written exam scores for all subjects improved, baseline median (IQR) 60 (46.47 to 66.67) post-course 80 (65 to 86.67), 6-month 80 (66.67 to 86.67) and 12-month 86.67 (80 to 88.34), p = <0.001. All subjects practical exam scores median (IQR) significantly improved, baseline 18.18 (7.95 to 32.95), post-course 59.09 (45.45 to 70.45), 6 month 71.74 (60.87 to 82.61) and 12-month 76.09 (65.22 to 88.05), p = <0.001. Comparing the control group to the intervention group, there were statistically significant higher scores, median (IQR), in the intervention group on the practical exam at 6 months 63.05 (48.92 to 69.57) vs. 82.61(72.83 to89.13), p = <0.001.
CONCLUSION
In this cohort, internal medicine residents participating in a structured thoracic ultrasound course plus 20-supervised ultrasounds achieved higher practical exam scores long-term compared to controls.",2020,"All subjects practical exam scores median (IQR) significantly improved, baseline 18.18 (7.95 to 32.95), post-course 59.09 (45.45 to 70.45), 6 month 71.74 (","['Twenty-eight residents were enrolled', 'internal medicine residents participating in a', 'internal medical residents']","['skill retention of thoracic ultrasound using a structured curriculum (control, n = 14) vs. structured curriculum plus 20 supervised bedside', 'structured thoracic ultrasound course plus 20-supervised ultrasounds', 'structured ultrasound curriculum vs. structured ultrasound curriculum plus supervised thoracic ultrasounds']","['Written exam scores', 'scores, median (IQR']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",28.0,0.041985,"All subjects practical exam scores median (IQR) significantly improved, baseline 18.18 (7.95 to 32.95), post-course 59.09 (45.45 to 70.45), 6 month 71.74 (","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Matthews', 'Affiliation': 'Cooper University Health Care, Camden, NJ, United States of America.'}, {'ForeName': 'Krysta', 'Initials': 'K', 'LastName': 'Contino', 'Affiliation': 'Cooper University Health Care, Camden, NJ, United States of America.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Nussbaum', 'Affiliation': 'Cooper University Health Care, Camden, NJ, United States of America.'}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Hunter', 'Affiliation': 'Cooper University Health Care, Camden, NJ, United States of America.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Schorr', 'Affiliation': 'Cooper University Health Care, Camden, NJ, United States of America.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Puri', 'Affiliation': 'Cooper University Health Care, Camden, NJ, United States of America.'}]",PloS one,['10.1371/journal.pone.0243086']
2561,33270685,Failure to modulate reward prediction errors in declarative learning with theta (6 Hz) frequency transcranial alternating current stimulation.,"Recent evidence suggests that reward prediction errors (RPEs) play an important role in declarative learning, but its neurophysiological mechanism remains unclear. Here, we tested the hypothesis that RPEs modulate declarative learning via theta-frequency oscillations, which have been related to memory encoding in prior work. For that purpose, we examined the interaction between RPE and transcranial Alternating Current Stimulation (tACS) in declarative learning. Using a between-subject (real versus sham stimulation group), single-blind stimulation design, 76 participants learned 60 Dutch-Swahili word pairs, while theta-frequency (6 Hz) tACS was administered over the medial frontal cortex (MFC). Previous studies have implicated MFC in memory encoding. We replicated our previous finding of signed RPEs (SRPEs) boosting declarative learning; with larger and more positive RPEs enhancing memory performance. However, tACS failed to modulate the SRPE effect in declarative learning and did not affect memory performance. Bayesian statistics supported evidence for an absence of effect. Our study confirms a role of RPE in declarative learning, but also calls for standardized procedures in transcranial electrical stimulation.",2020,"However, tACS failed to modulate the SRPE effect in declarative learning and did not affect memory performance.",[],"['RPE and transcranial Alternating Current Stimulation (tACS', 'tACS']","['memory performance', 'SRPE effect in declarative learning']",[],"[{'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C1285654', 'cui_str': 'Memory performance'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",76.0,0.092762,"However, tACS failed to modulate the SRPE effect in declarative learning and did not affect memory performance.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Ergo', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'De Loof', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Debra', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Pastötter', 'Affiliation': 'Department of Psychology, University of Trier, Trier, Germany.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Verguts', 'Affiliation': 'Department of Experimental Psychology, Ghent University, Ghent, Belgium.'}]",PloS one,['10.1371/journal.pone.0237829']
2562,33270676,TST conversions and systemic interferon-gamma increase after methotrexate introduction in psoriasis patients.,"BACKGROUND
Tuberculosis screening in psoriasis patients is complex due to the immunological alterations associated with psoriasis, the presence of comorbidities, and the effect of immunosuppressive treatment. However, it is not established whether the results of screening tests are affected by these factors in psoriasis patients.
OBJECTIVES
To determine whether there is a change in the results of the tuberculin skin test (TST) or the interferon-gamma release assay (IGRA) in psoriasis patients living in tuberculosis (TB)-endemic area after 12 weeks of methotrexate (MTX) treatment and to investigate the association of the test results with clinical and inflammatory markers.
METHODS
Forty-five patients were selected for a prospective single-arm self-controlled study and followed for at least 18 months. The TST, IGRA, Psoriasis Area and Severity Index (PASI), and inflammatory factors (erythrocyte sedimentation rate (ESR), C-reactive protein, interferon-gamma (IFN-γ), and tumor necrosis factor-alpha levels), were determined before and after 12 weeks of oral 15 mg per week MTX administration and compared. The associations between the IGRA and TST results were verified before and after treatment according to inflammatory factors and clinical characteristics (age, blood glucose, weight, body mass index, disease duration, and PASI).
RESULTS
We collected data on 25 patients who completed the full course of therapy and the follow-up. None of the patients developed TB. TST positivity was significantly elevated at week 12 (25% baseline vs 44% at week 12, P < 0.037). Three IGRAs followed the TST conversions. There was no difference between TST and IGRA pre- or posttreatment. Serum IFN-γ increased significantly in week 12 (15.95 pg/ml baseline vs 18.82 pg/ml at week 12, P < 0.005) and tended to be higher among TST-positive patients (P = 0.072). The baseline IGRA was associated with a higher ESR (P = 0.038). None of the test results were associated with clinical characteristics.
CONCLUSIONS
In addition to the classic booster effect, TST conversions in patients using MTX can occur due to an increase in IFN-γ. However, it is not possible to exclude true TST conversions. Therefore, other diagnostic methods, like IGRA or chest tomography, should be used when the TST has intermediate results.",2020,"TST positivity was significantly elevated at week 12 (25% baseline vs 44% at week 12, P < 0.037).","['psoriasis patients living in tuberculosis (TB)-endemic area after 12 weeks of', '25 patients who completed the full course of therapy and the follow-up', 'psoriasis patients', 'Forty-five patients were selected for a prospective single-arm self-controlled study and followed for at least 18 months']","['tuberculin skin test (TST) or the interferon-gamma release assay (IGRA', 'methotrexate (MTX', 'MTX']","['TST positivity', 'Serum IFN-γ', 'TST, IGRA, Psoriasis Area and Severity Index (PASI), and inflammatory factors (erythrocyte sedimentation rate (ESR), C-reactive protein, interferon-gamma (IFN-γ), and tumor necrosis factor-alpha levels', 'inflammatory factors and clinical characteristics (age, blood glucose, weight, body mass index, disease duration, and PASI', 'TST conversions and systemic interferon-gamma increase', 'IFN-γ']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C3178802', 'cui_str': 'Interferon gamma release assay'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021745', 'cui_str': 'Interferon Type II'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",45.0,0.0668119,"TST positivity was significantly elevated at week 12 (25% baseline vs 44% at week 12, P < 0.037).","[{'ForeName': 'Vanessa Lucília Silveira', 'Initials': 'VLS', 'LastName': 'de Medeiros', 'Affiliation': 'Dermatology Clinic, Clinics Hospital, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}, {'ForeName': 'Fabiana Cristina Fulco', 'Initials': 'FCF', 'LastName': 'Santos', 'Affiliation': 'Department of Immunology, Laboratory of Immunoepidemiology, Aggeu Magalhães Research Center (CPqAM), Fiocruz, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}, {'ForeName': 'Lílian Maria Lapa', 'Initials': 'LML', 'LastName': 'Montenegro', 'Affiliation': 'Department of Immunology, Laboratory of Immunoepidemiology, Aggeu Magalhães Research Center (CPqAM), Fiocruz, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}, {'ForeName': 'Maria da Conceição', 'Initials': 'MDC', 'LastName': 'Silva', 'Affiliation': 'Department of Tropical Medicine, Clinics Hospital, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}, {'ForeName': 'Valdênia Maria Oliveira de', 'Initials': 'VMO', 'LastName': 'Souza', 'Affiliation': 'Department of Tropical Medicine, Clinics Hospital, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}, {'ForeName': 'Reginaldo Gonçalvez de', 'Initials': 'RG', 'LastName': 'Lima Neto', 'Affiliation': 'Department of Tropical Medicine, Clinics Hospital, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}, {'ForeName': 'Líbia Cristina Rocha Vilela', 'Initials': 'LCRV', 'LastName': 'Moura', 'Affiliation': 'Department of Tropical Medicine, Clinics Hospital, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Magalhães', 'Affiliation': 'Department of Tropical Medicine, Clinics Hospital, Federal University of Pernambuco (UFPE), Recife, PE, Brazil.'}]",PloS one,['10.1371/journal.pone.0242098']
2563,33270513,High-intensity interval exercise in the cold regulates acute and postprandial metabolism.,"High-Intensity Interval Exercise (HIIE) has been shown to be more effective than moderate-intensity exercise for increasing acute lipid oxidation and lowering blood lipids during exercise and postprandially. Exercise in cold environments is also known to enhance lipid oxidation, however the immediate and long-term effects of HIIE exercise in cold are unknown. The purpose of this study was to examine the effects cold stress during HIIE on acute exercise metabolism and postprandial metabolism. Eleven recreationally active individuals (age: 23±3 years, weight: 80±9.7 kg, V̇O 2peak : 39.2±5.73 mL·kg -1 ·min -1 ) performed evening HIIE sessions (10x60s cycling, 90% V̇O 2peak interspersed with 90s active recovery, 30% V̇O 2peak ) in thermoneutral (HIIE-TN, control; 21°C) and cold environments (HIIE-CO; 0°C), following a balanced crossover design. The following morning, participants consumed a high-fat meal. Indirect calorimetry was used to assess substrate oxidation, and venous blood samples were obtained to assess changes in noncellular metabolites. During acute exercise, lipid oxidation was 113% higher in HIIE-CO (p=0.002) without differences in V̇O 2 and EE (p≥0.162) between conditions. Postprandial V̇O 2 , lipid and CHO oxidation, plasma insulin and triglyceride concentrations were not different between conditions (p>0.05). Postprandial blood LDL-C levels were higher in HIIE-CO two hours after the meal (p=0.003). Postprandial glucose AUC was 49% higher in HIIE-CO vs HIIE-TN (p=0.034). Under matched energy expenditure conditions, HIIE demonstrated higher lipid oxidation rates during exercise in the cold; but only marginally influenced postprandial lipid metabolism the following morning. In conclusion, HIIE in the cold seemed to be less favorable for postprandial lipid and glycemic responses.",2020,"During acute exercise, lipid oxidation was 113% higher in HIIE-CO (p=0.002) without differences in V̇O 2 and EE (p≥0.162) between conditions.","['Eleven recreationally active individuals (age: 23±3 years, weight: 80±9.7 kg, V̇O 2peak : 39.2±5.73 mL·kg -1 ·min -1 ) performed']","['evening HIIE sessions (10x60s cycling, 90% V̇O 2peak interspersed with 90s active recovery, 30% V̇O 2peak ) in thermoneutral (HIIE-TN, control; 21°C) and cold environments (HIIE-CO; 0°C', 'High-Intensity Interval Exercise (HIIE', 'High-intensity interval exercise']","['Postprandial glucose', 'Postprandial V̇O 2 , lipid and CHO oxidation, plasma insulin and triglyceride concentrations', 'substrate oxidation, and venous blood samples', 'lipid oxidation', 'AUC', 'lipid oxidation rates', 'postprandial lipid metabolism', 'postprandial lipid and glycemic responses', 'acute exercise metabolism and postprandial metabolism', 'Postprandial blood LDL-C levels']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241842', 'cui_str': 'Cold environment'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",11.0,0.0767291,"During acute exercise, lipid oxidation was 113% higher in HIIE-CO (p=0.002) without differences in V̇O 2 and EE (p≥0.162) between conditions.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Munten', 'Affiliation': 'Laboratory of Environmental Exercise Physiology, School of Human Kinetics, Laurentian University, Canada.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Ménard', 'Affiliation': 'Laboratory of Environmental Exercise Physiology, School of Human Kinetics, Laurentian University, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gagnon', 'Affiliation': 'Department of Biology, Laurentian University, Canada.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Dorman', 'Affiliation': 'Laboratory of Environmental Exercise Physiology, School of Human Kinetics, Laurentian University, Canada.'}, {'ForeName': 'Ania', 'Initials': 'A', 'LastName': 'Mezouari', 'Affiliation': 'Department of Biology, Laurentian University, Canada.'}, {'ForeName': 'Dominique D', 'Initials': 'DD', 'LastName': 'Gagnon', 'Affiliation': 'School of Human Kinetics, Laurentian University, Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00384.2020']
2564,33270499,The Comparative Efficacy of Conventional Short-Stretch Multilayer Bandages and Velcro Adjustable Compression Wraps in Active Treatment Phase of Patients with Lower Limb Lymphedema.,"Background: Compression is the most important component of complete decongestive therapy (CDT), but there is no standard best method for applying compression. The aim of this study was to evaluate the comparative efficacy of conventional multilayer short-stretch bandaging, and a velcro adjustable compression wrap with regard to volume reduction, ultrasonographic measurements, functional-status, and quality of life (QoL) in the active CDT period of patients with lower limb lymphedema. Methods and Results: The demographic and clinical variables of lower limb lymphedema patients were recorded. All patients received skin care education, manual lymphatic drainage, and supervised lyphedema exercises, and were randomly allocated to Group1 (multilayer short-stretch bandaging-Rosidal-K ® ) or to Group 2 (adjustable-compression-velcro-wrap-Circaid Juxtalite ® ) for a duration of 3 weeks with 15 sessions. Limb volumes were assessed by perometer. Ultrasonographic measurements included subcutaneous soft tissue thickness. The functional disability and QoL were evaluated by the Lower Extremity Functional Scale and LYMQOL-Leg (Lymphedema Quality of Life Questionnaire-Leg), respectively, at baseline, after CDT, and at first-month follow-up. Thirty-six patients (10 male and 26 female) with mean age of 51.6 ± 11.7 years were included. Fourteen patients had primary and 22 patients had secondary lymphedema. The median duration of lymphedema was 68 months. Significant improvements in volumes and ultrasonographic measurments were observed in both groups at the end of therapies, and improvements sustained up to a month. Appearance, symptoms, and overall QoL-subscores were improved only in Group 2. Conclusion: In conclusion, adjustable compression velcro-wrap performed as a part of CDT can greatly reduce the volume similiar to conventional multilayer bandages, as well as improve the QoL. It can be a comfortable alternative to the conventional multilayer bandages in the active treatment phase of the CDT.",2020,"Significant improvements in volumes and ultrasonographic measurments were observed in both groups at the end of therapies, and improvements sustained up to a month.","['Fourteen patients had primary and 22 patients had secondary lymphedema', 'Thirty-six patients (10 male and 26 female) with mean age of 51.6\u2009±\u200911.7 years were included', 'Patients with Lower Limb Lymphedema', 'patients with lower limb lymphedema']","['Group1', 'conventional multilayer short-stretch bandaging', 'skin care education, manual lymphatic drainage, and supervised lyphedema exercises', 'multilayer short-stretch bandaging-Rosidal-K ® ) or to Group 2 (adjustable-compression-velcro-wrap-Circaid Juxtalite ® ', 'Conventional Short-Stretch Multilayer Bandages and Velcro Adjustable Compression Wraps']","['functional disability and QoL', 'volume reduction, ultrasonographic measurements, functional-status, and quality of life (QoL', 'Limb volumes', 'Lower Extremity Functional Scale and LYMQOL-Leg (Lymphedema Quality of Life Questionnaire-Leg', 'Appearance, symptoms, and overall QoL-subscores', 'volumes and ultrasonographic measurments', 'subcutaneous soft tissue thickness', 'median duration of lymphedema']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517535', 'cui_str': '11.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage'}, {'cui': 'C1444384', 'cui_str': 'Skin care education'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0453982', 'cui_str': 'Velcro'}, {'cui': 'C0677875', 'cui_str': 'Compression Bandage'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",,0.0264523,"Significant improvements in volumes and ultrasonographic measurments were observed in both groups at the end of therapies, and improvements sustained up to a month.","[{'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Borman', 'Affiliation': 'Ankara City Hospital, Department of Physical Medicine and Rehabilitation, Bilkent, Ankara, Turkey.'}, {'ForeName': 'Esra G', 'Initials': 'EG', 'LastName': 'Koyuncu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Hacettepe Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'Yaman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gulhane Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Calp', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Hacettepe Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Koç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Hacettepe Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Rüveyda', 'Initials': 'R', 'LastName': 'Sargut', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Hacettepe Faculty of Medicine, Ankara, Turkey.'}, {'ForeName': 'Sevilay', 'Initials': 'S', 'LastName': 'Karahan', 'Affiliation': 'Department of Biostatistics, University of Hacettepe Faculty of Medicine, Ankara, Turkey.'}]",Lymphatic research and biology,['10.1089/lrb.2020.0088']
2565,33270487,"Safety and immunogenicity of meningococcal (Groups A and C) polysaccharide vaccine in children 2 to 6 y of age in China: a randomized, active-controlled, non-inferiority study.","Meningococcal serogroups A and C cause significant numbers of cases in China. The Sanofi Pasteur meningococcal polysaccharide A + C vaccine (Men-AC) was licensed in China in 1995. Immunogenicity and safety of a single dose of Men-AC against a similar marketed vaccine, the Lanzhou Institute serogroups A and C vaccine (Lanzhou-AC), were evaluated in children 2 to 6 y of age. Antibody titers were determined before and on Day 30 after vaccination using a serum bactericidal assay using baby rabbit complement (SBA-BR). Immunogenicity endpoints included rates of seroconversion (postvaccination antibody titers ≥4-fold higher) and seroprotection (postvaccination titers ≥1:8). Unsolicited systemic adverse events (AEs) within 30 minutes after vaccination, solicited injection site and systemic reactions between Days 0 and 7, unsolicited non-serious AEs within 30 d, and serious adverse events (SAEs) throughout were recorded. Seroconversion rates against serogroups A and C were 97.0% (95% confidence interval [CI], 94.5-98.6) and 94.7% (95% CI, 91.6-97.0), respectively, in the Men-AC group and 97.7% (95% CI, 95.4-99.1) and 94.8% (95% CI, 91.7-97.0), respectively, in the Lanzhou-AC group, while seroprotection rates were 98.0% (95% CI, 95.8-99.3) and 97.0% (95% CI, 94.5-98.6), respectively, in the Men-AC group and 99.0% (95% CI, 97.2-99.8) and 96.8% (95% CI, 94.1-98.4), respectively, in the Lanzhou-AC group. Non-inferiority of Men-AC with regard to immunogenicity was demonstrated since the lower bounds of the 95% CIs of the differences in rates between the two groups were > -5% for both serogroups. Both vaccines were well tolerated.",2020,"Seroconversion rates against serogroups A and C were 97.0% (95% confidence interval [CI], 94.5-98.6) and 94.7% (95% CI, 91.6-97.0), respectively, in the Men-AC group and 97.7% (95% CI, 95.4-99.1) and 94.8% (95% CI, 91.7-97.0), respectively, in the Lanzhou-AC group, while seroprotection rates were 98.0% (95% CI, 95.8-99.3) and 97.0% (95% CI, 94.5-98.6), respectively, in the Men-AC group and 99.0% (95% CI, 97.2-99.8) and 96.8% (95% CI, 94.1-98.4), respectively, in the Lanzhou-AC group.","['children', 'children 2 to 6\xa0y of age', 'Men-AC) was licensed in China in 1995', '2 to 6 y of age in China']","['Lanzhou Institute serogroups A and C vaccine (Lanzhou-AC', 'Sanofi Pasteur meningococcal polysaccharide A +\xa0C vaccine', 'meningococcal (Groups A and C) polysaccharide vaccine']","['Antibody titers', 'Immunogenicity and safety', 'solicited injection site and systemic reactions', 'Seroconversion rates against serogroups A and C', 'Safety and immunogenicity', 'serious adverse events (SAEs', 'tolerated', 'seroprotection rates', 'Unsolicited systemic adverse events (AEs', 'rates of seroconversion (postvaccination antibody titers ≥4-fold higher) and seroprotection (postvaccination titers ≥1:8']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0065942', 'cui_str': 'meningococcal group A polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0065942', 'cui_str': 'meningococcal group A polysaccharide'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}]","[{'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.363478,"Seroconversion rates against serogroups A and C were 97.0% (95% confidence interval [CI], 94.5-98.6) and 94.7% (95% CI, 91.6-97.0), respectively, in the Men-AC group and 97.7% (95% CI, 95.4-99.1) and 94.8% (95% CI, 91.7-97.0), respectively, in the Lanzhou-AC group, while seroprotection rates were 98.0% (95% CI, 95.8-99.3) and 97.0% (95% CI, 94.5-98.6), respectively, in the Men-AC group and 99.0% (95% CI, 97.2-99.8) and 96.8% (95% CI, 94.1-98.4), respectively, in the Lanzhou-AC group.","[{'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Prevention and Control , Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Prevention and Control , Nanjing, Jiangsu Province, China.'}, {'ForeName': 'Ya-Nan', 'Initials': 'YN', 'LastName': 'Li', 'Affiliation': 'National Institutes for Food and Drug Control , Beijing, China.'}, {'ForeName': 'Jean-Denis', 'Initials': 'JD', 'LastName': 'Shu', 'Affiliation': 'China Medical Affairs, Sanofi Pasteur China , Beijing, China.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Oster', 'Affiliation': 'Sanofi Pasteur , Lyon, France.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1801077']
2566,33275382,Exercise as Treatment for Youth With Major Depression: The Healthy Body Healthy Mind Feasibility Study.,"The goals of this study were to determine the feasibility of engaging youth with major depressive disorder (MDD) in a multimodal exercise intervention (Healthy Body Healthy Mind) plus usual care and to evaluate the magnitude of its effects on psychological, physical fitness, and biomarker outcomes to inform a future randomized controlled trial. Youth (15 to 25 y of age) with MDD diagnosed using the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) were eligible to participate. Feasibility measures included recruitment, retention, and program adherence rates. The exercise program consisted of a single session of motivational interviewing to enhance exercise adherence, then 1-hour, small-group supervised exercise sessions 3 times per week for 12 weeks. Assessments were administered at baseline and at 12 weeks. Depression symptoms were assessed using the Beck Depression Inventory (BDI-II). Physical fitness and blood biomarkers were also measured. Three males and 10 females with MDD, who were 18 to 24 years of age, participated. Retention at 12 weeks was 86%, and attendance at exercise sessions averaged 62%±28%. After 12 weeks, 69% of participants experienced a remission of MDD based on the SCID. Mean BDI-II scores decreased from 31.9±9.1 to 13.1±10.1 [Cohen d effect size (ES)=1.96]. Improvements were observed in upper (ES=0.64) and lower (ES=0.32) body muscular endurance. Exercise session attendance was moderately correlated with changes in BDI-II scores (Pearson r=0.49). It appears feasible to attract and engage some youth with MDD in an exercise intervention. The positive impact on depression symptoms justifies further studies employing exercise interventions as an adjunct to routine care for young people with MDD.",2020,Mean BDI-II scores decreased from 31.9±9.1 to 13.1±10.1 [Cohen d effect size (ES)=1.96].,"['Youth (15 to 25\u2009y of age) with MDD diagnosed using the Structured Clinical Interview for DSM-IV Axis', 'Three males and 10 females with MDD, who were 18 to 24 years of age, participated', 'engaging youth with major depressive disorder (MDD', 'young people with MDD', 'Youth With Major Depression']","['exercise interventions', 'Exercise', 'multimodal exercise intervention (Healthy Body Healthy Mind) plus usual care']","['Depression symptoms', 'remission of MDD', 'body muscular endurance', 'Beck Depression Inventory (BDI-II', 'recruitment, retention, and program adherence rates', 'Exercise session attendance', 'Physical fitness and blood biomarkers', 'Mean BDI-II scores', 'BDI-II scores']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",3.0,0.0333799,Mean BDI-II scores decreased from 31.9±9.1 to 13.1±10.1 [Cohen d effect size (ES)=1.96].,"[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Giles', 'Affiliation': 'GILES: Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Callaghan, NSW, Australia NASSTASIA, HALPIN: School of Psychology, University of Newcastle, Callaghan, NSW, Australia BAKER, KELLY: School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia DASCOMBE: Priority Research Centre for Physical Activity and Nutrition and School of Environmental and Life Sciences, University of Newcastle, Callaghan, NSW, Australia HIDES: School of Psychology, University of Queensland, St Lucia, Qld, Australia CALLISTER: Priority Research Centre for Physical Activity and Nutrition, and School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Yasmina', 'Initials': 'Y', 'LastName': 'Nasstasia', 'Affiliation': ''}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Dascombe', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Halpin', 'Affiliation': ''}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': ''}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Callister', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000516']
2567,33275326,"Extended-release naltrexone/bupropion and liver health: pooled, post-hoc analysis from 4 RCTs.","Sustained weight loss improves liver histology in non-alcoholic fatty liver disease. This post-hoc analysis of four phase III, 56-week, randomized, controlled trials investigated if extended-release naltrexone and bupropion (NB) affects alanine aminotransferase (ALT) and Fibrosis Index (FIB-4) in adults with overweight or obesity. 2073 subjects (NB = 1310; placebo = 763; 79.0% female; 81.6% Caucasian) had baseline mean: weight 101 kg, BMI 36.2 kg/m 2 , ALT 26.9 IU/L, and FIB-4 0.79. At 56 weeks, NB-treated subjects experienced more weight loss than placebo (8.7 kg vs. 3.2 kg, respectively, p<0.0001). Weight loss, independent of treatment, was associated with improved ALT and FIB-4 (p<0.0001). There was a significant independent effect of NB on change from baseline for FIB-4 (p<0.0001), but not for ALT (p=0.54). Categorical ALT response (from above to within normal ranges: 10-40 IU/L for men; 7-35 IU/L for women) and achievement of 25% and 50% reduction in ALT were greater for NB vs. placebo, and independently affected by weight loss (p<0.0001), but not treatment. NB-associated weight loss may improve liver health by normalizing ALT values for those with high baseline levels. This article is protected by copyright. All rights reserved.",2020,"Weight loss, independent of treatment, was associated with improved ALT and FIB-4 (p<0.0001).","['adults with overweight or obesity', '2073 subjects (NB\xa0=\xa01310; placebo\xa0=\xa0763; 79.0% female; 81.6% Caucasian) had baseline mean: weight 101 kg, BMI 36.2 kg/m 2 , ALT 26.9 IU/L, and FIB-4 0.79']","['naltrexone/bupropion', 'naltrexone and bupropion (NB', 'placebo']","['Categorical ALT response', 'weight loss', 'alanine aminotransferase (ALT) and Fibrosis Index (FIB-4', 'ALT', 'Weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",2073.0,0.291568,"Weight loss, independent of treatment, was associated with improved ALT and FIB-4 (p<0.0001).","[{'ForeName': 'Harpreet S', 'Initials': 'HS', 'LastName': 'Bajaj', 'Affiliation': 'LMC Diabetes and Endocrinology, Brampton, ON, Canada.'}, {'ForeName': 'Melonie', 'Initials': 'M', 'LastName': 'Burrows', 'Affiliation': 'Bausch Health, Laval, QC, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Blavignac', 'Affiliation': 'Bausch Health, Laval, QC, Canada.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Paron', 'Affiliation': 'Bausch Health, Laval, QC, Canada.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Camacho', 'Affiliation': 'University of Waterloo, Department of Statistics and Actuarial Sciences, Waterloo, ON, Canada.'}, {'ForeName': 'Errol', 'Initials': 'E', 'LastName': 'Gould', 'Affiliation': 'Currax Pharmaceuticals LLC, Morristown, NJ, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Barakat', 'Affiliation': 'Bausch Health, Laval, QC, Canada.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14284']
2568,33275318,"Efficacy And Safety Of Imeglimin In Japanese Patients With Type 2 Diabetes Mellitus: A 24-Week, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Phase 2b Trial.","AIMS
The aim of this study was to assess the efficacy and safety of imeglimin monotherapy compared to placebo for 24 weeks in Japanese patients with type 2 diabetes mellitus (T2DM).
MATERIAL AND METHODS
In this 24-week, randomized, double-blind, placebo-controlled, parallel group, dose ranging, phase 2b clinical trial, Japanese adults (age ≥ 20 years) with T2DM either treatment-naïve or previously treated with one oral anti-diabetes agent were eligible for participation. Patients were randomly assigned (1:1:1:1) to receive orally imeglimin 500 mg or imeglimin 1000 mg or imeglimin 1500 mg, or placebo twice daily over a 24-week period. The primary endpoint was the placebo-adjusted change at week 24 in HbA1c. Safety outcomes were assessed in all patients that received at least one dose of study drug. This trial is registered at JAPIC (JapicCTI-153086).
RESULTS
A total of 299 patients were randomized to receive double-blind treatment with orally twice-daily placebo (n= 75), imeglimin 500 mg (n=75), 1000 mg (n=74) or 1500 mg (n=75). At week 24, imeglimin significantly decreased HbA1c (difference vs placebo: imeglimin 500 mg -0.52% (95% CI: -0.77, -0.27), imeglimin 1000 mg -0.94% (95% CI: -1.19, -0.68), imeglimin 1500 mg -1.00% (95% CI: -1.26, -0.75) (p < 0.0001 for all). Treatment-emergent adverse events (TEAE) were reported for 68.0%, 62.2%, 73.3% and 68.0% of patients receiving imeglimin 500 mg, imeglimin 1000 mg, imeglimin 1500 mg and placebo, respectively. A small increase in gastrointestinal adverse effects (e.g. diarrhea) occurred with the 1500 mg dose level. Hypoglycemia was balanced between groups.
CONCLUSIONS
Imeglimin as monotherapy in Japanese patients with T2DM was well tolerated and significantly improved glycemic control with no significant increase in hypoglycemic events versus placebo. Given the marginal increase in efficacy with the 1500 mg vs. 1000 mg dose (along with the potential for gastrointestinal tolerability issues), a dose of 1000 mg BID was selected for subsequent Phase III studies. This article is protected by copyright. All rights reserved.",2020,"At week 24, imeglimin significantly decreased HbA1c (difference vs placebo: imeglimin 500 mg -0.52% (95% CI: -0.77, -0.27), imeglimin 1000 mg -0.94% (95% CI: -1.19, -0.68), imeglimin 1500 mg -1.00% (95% CI: -1.26, -0.75) (p < 0.0001 for all).","['Japanese patients with type 2 diabetes mellitus (T2DM', 'A total of 299 patients', 'Japanese adults (age ≥\u200920\u2009years) with T2DM either treatment-naïve or previously treated with one oral anti-diabetes agent were eligible for participation', 'Japanese patients with T2DM', 'Japanese Patients With Type 2 Diabetes Mellitus']","['placebo', 'Imeglimin', 'orally imeglimin 500 mg or imeglimin 1000 mg or imeglimin 1500 mg, or placebo', 'Placebo', 'imeglimin monotherapy', 'imeglimin 500 mg']","['Safety outcomes', 'placebo-adjusted change at week 24 in HbA1c', 'Hypoglycemia', 'hypoglycemic events', 'gastrointestinal adverse effects (e.g. diarrhea', 'efficacy and safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3501765', 'cui_str': 'imeglimin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",299.0,0.552657,"At week 24, imeglimin significantly decreased HbA1c (difference vs placebo: imeglimin 500 mg -0.52% (95% CI: -0.77, -0.27), imeglimin 1000 mg -0.94% (95% CI: -1.19, -0.68), imeglimin 1500 mg -1.00% (95% CI: -1.26, -0.75) (p < 0.0001 for all).","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dubourg', 'Affiliation': 'POXEL, Lyon, France.'}, {'ForeName': 'Kohjiro', 'Initials': 'K', 'LastName': 'Ueki', 'Affiliation': 'Diabetes Research Center, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Grouin', 'Affiliation': 'Inserm 1219, Bordeaux, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Fouqueray', 'Affiliation': 'POXEL, Lyon, France.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14285']
2569,33275278,Interventions for leg cramps in pregnancy.,"BACKGROUND
Leg cramps are a common problem in pregnancy. Various interventions have been used to treat them, including drug, electrolyte and vitamin therapies, and non-drug therapies. This Cochrane Review is an update of a review first published in 2015.
OBJECTIVES
To assess the effectiveness and safety of different interventions for treating leg cramps in pregnancy.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (25 September 2019), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) of any intervention for the treatment of leg cramps in pregnancy compared with placebo, no treatment or other treatments. Quinine was excluded for its known adverse effects. Cluster-RCTS were eligible for inclusion. Quasi-RCTs and cross-over studies were excluded.
DATA COLLECTION AND ANALYSIS
Three review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. The certainty of the evidence was assessed using the GRADE approach.
MAIN RESULTS
We included eight small studies (576 women). Frequency of leg cramps was our primary outcome and secondary outcomes included intensity and duration of leg cramps, adverse outcomes for mother and baby and health-related quality of life. Overall, the studies were at low or unclear risk of bias. Outcomes were reported in different ways, precluding the use of meta-analysis and thus data were limited to single trials. Certainty of evidence was assessed as either low or very-low due to serious limitations in study design and imprecision. Oral magnesium versus placebo/no treatment The results for frequency of leg cramps were inconsistent. In one study, results indicated that women may be more likely to report never having any leg cramps after treatment (risk ratio (RR) 5.66, 95% confidence interval (CI) 1.35 to 23.68, 1 trial, 69 women, low-certainty evidence); whilst fewer women may report having twice-weekly leg cramps (RR 0.29, 95% CI 0.11 to 0.80, 1 trial, 69 women); and more women may report a 50% reduction in number of leg cramps after treatment (RR 1.42, 95% CI 1.09 to 1.86, 1 trial, 86 women, low-certainty evidence). However, other findings indicated that magnesium may make little to no difference in the frequency of leg cramps during differing periods of treatment. For pain intensity, again results were inconsistent. Findings indicated that magnesium may make little or no difference: mean total pain score (MD 1.80, 95% CI -3.10 to 6.70, 1 trial, 38 women, low-certainty evidence). In another study the evidence was very uncertain about the effects of magnesium on pain intensity as measured in terms of a 50% reduction in pain. Findings from another study indicated that magnesium may reduce pain intensity according to a visual analogue scale (MD -17.50, 95% CI -34.68 to -0.32,1 trial, 69 women, low-certainty evidence). For all other outcomes examined there may be little or no difference: duration of leg cramps (low to very-low certainty); composite outcome - symptoms of leg cramps (very-low certainty); and for any side effects, including nausea and diarrhoea (low certainty). Oral calcium versus placebo/no treatment The evidence is unclear about the effect of calcium supplements on frequency of leg cramps because the certainty was found to be very low: no leg cramps after treatment (RR 8.59, 95% CI 1.19 to 62.07, 1 study, 43 women, very low-certainty evidence). In another small study, the findings indicated that the mean frequency of leg cramps may be slightly lower with oral calcium (MD -0.53, 95% CI -0.72 to -0.34; 1 study, 60 women; low certainty). Oral vitamin B versus no treatment One small trial, did not report on frequency of leg cramps individually, but showed that oral vitamin B supplements may reduce the frequency and intensity (composite outcome) of leg cramps (RR 0.29, 95% CI 0.11 to 0.73; 1 study, 42 women). There were no data on side effects. Oral calcium versus oral vitamin C The evidence is very uncertain about the effect of calcium on frequency of leg cramps after treatment compared with vitamin C (RR 1.33, 95% CI 0.53 to 3.38, 1 study, 60 women, very low-certainty evidence). Oral vitamin D versus placebo One trial (84 women) found vitamin D may make little or no difference to frequency of leg cramps compared with placebo at three weeks (MD 2.06, 95% CI 0.58 to 3.54); or six weeks after treatment (MD 1.53, 95% CI 0.12 to 2.94). Oral calcium-vitamin D versus placebo One trial (84 women) found oral calcium-vitamin D may make little or no difference to frequency of leg cramps compared with placebo after treatment at three weeks (MD -0.30, 95% CI -1.55 to 0.95); and six weeks (MD 0.03, 95% CI -1.3 to 1.36). Oral calcium-vitamin D versus vitamin D One trial (84 women) found oral calcium-vitamin D may make little or no difference to frequency of leg cramps compared with vitamin D after treatment at three weeks (MD -1.35, 95% CI -2.84 to 0.14); and six weeks after treatment (MD -1.10, 95% CI -2.69 to 0.49).
AUTHORS' CONCLUSIONS
It is unclear from the evidence reviewed whether any of the interventions provide an effective treatment for leg cramps. This is primarily due to outcomes being measured and reported in different, incomparable ways so that data could not be pooled. The certainty of evidence was found to be low or very-low due to design limitations and trials being too small to address the question satisfactorily. Adverse outcomes were not reported, other than side effects for magnesium versus placebo/no treatment. It is therefore not possible to assess the safety of these interventions. The inconsistency in the measurement and reporting of outcomes meant that meta-analyses could not be carried out. The development of a core outcome set for measuring the frequency, intensity and duration of leg cramps would address these inconsistencies and mean these outcomes could be investigated effectively in the future.",2020,"Findings indicated that magnesium may make little or no difference: mean total pain score (MD 1.80, 95% CI -3.10 to 6.70, 1 trial, 38 women, low-certainty evidence).","['eight small studies (576 women', 'leg cramps in pregnancy']","['placebo', 'oral calcium-vitamin D', 'Oral calcium-vitamin D versus placebo', 'vitamin C', 'Oral calcium versus placebo/no treatment', 'magnesium', 'Oral vitamin D versus placebo', 'Oral calcium-vitamin D versus vitamin D', 'Oral calcium versus oral vitamin C', 'Oral vitamin B', 'vitamin D', 'Oral magnesium versus placebo', 'calcium supplements']","['intensity and duration of leg cramps, adverse outcomes for mother and baby and health-related quality of life', 'mean frequency of leg cramps', 'report having twice-weekly leg cramps', 'pain intensity', 'nausea and diarrhoea', 'side effects', 'Adverse outcomes', 'frequency of leg cramps', 'frequency and intensity (composite outcome) of leg cramps', 'effectiveness and safety', 'total pain score', 'leg cramps', 'number of leg cramps', 'Frequency of leg cramps']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023218', 'cui_str': 'Leg cramps'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0719107', 'cui_str': 'Calcium and vitamin D product'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C3540037', 'cui_str': 'Calcium supplement'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0023218', 'cui_str': 'Leg cramps'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",69.0,0.572219,"Findings indicated that magnesium may make little or no difference: mean total pain score (MD 1.80, 95% CI -3.10 to 6.70, 1 trial, 38 women, low-certainty evidence).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Liangzhi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Obstetrics and Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Weiyao', 'Initials': 'W', 'LastName': 'Yin', 'Affiliation': 'West China Second University Hospital, Sichuan University, Chengdu, China.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD010655.pub3']
2570,33275162,Quality of life and sexual function after TVT surgery versus Bulkamid injection for primary stress urinary incontinence: 1 year results from a randomized clinical trial.,"INTRODUCTION AND HYPOTHESIS
To assess changes in quality of life (QoL) and sexual function outcomes at 1 year after tension-free vaginal tape (TVT) versus polyacrylamide hydrogel injection (PAHG).
METHODS
In a randomized trial comparing TVT (n = 111) and PAHG (n = 113) treatments of stress urinary incontinence (SUI), we compared urinary incontinence and health-related QoL using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and 1 year.
RESULTS
UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort. At 1 year, TVT patients experienced less urinary symptom-related distress compared to PAHG (p < 0.001). Sexual function improved in both groups (p < 0.001 for TVT and p = 0.01 for PAHG) with higher scores for the physical section subscale (p < 0.001) for TVT. Health-related QoL (RAND-36) improved from baseline in both groups in physical and social functioning (p < 0.001) with better outcome in the TVT group for physical functioning (p < 0.001). Increase in pain from baseline (p = 0.02) was detected for TVT, but not for PAHG. However, there was no difference between the groups (p = 0.78).
CONCLUSIONS
In primary SUI, TVT and PAHG treatments both improved QoL and sexual function at 1 year. However, incontinence and health-related QoL scores were better in the TVT group. More pain compared to the baseline was reported after TVT, although there was no difference between groups. Clinical significance needs to be evaluated in long-term follow-up.",2020,"RESULTS
UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort.",['primary stress urinary incontinence'],"['TVT surgery versus Bulkamid injection', 'TVT', 'PAHG', 'tension-free vaginal tape (TVT) versus polyacrylamide hydrogel injection (PAHG']","['incontinence-related QoL', 'urinary incontinence and health-related QoL using the Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and RAND-36 Item Health Survey (RAND-36) at baseline and 1\xa0year', 'Quality of life and sexual function', 'quality of life (QoL) and sexual function outcomes', 'Sexual function', 'incontinence and health-related QoL scores', 'QoL and sexual function', 'Increase in pain', 'urinary symptom-related distress', 'Health-related QoL (RAND-36', 'physical section subscale', 'stress urinary incontinence (SUI', 'More pain']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]","[{'cui': 'C1721083', 'cui_str': 'Tension-Free Vaginal Tape'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2353119', 'cui_str': 'Bulkamid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0137704', 'cui_str': 'polyacrylamide hydrogels'}]","[{'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}]",,0.113446,"RESULTS
UDI-6 and IIQ-7 showed improved incontinence-related QoL (p = 0.001) from baseline in both groups except for difficulty emptying the bladder and pain/discomfort.","[{'ForeName': 'Anna-Maija', 'Initials': 'AM', 'LastName': 'Itkonen Freitas', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, PO BOX 140, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Tomi S', 'Initials': 'TS', 'LastName': 'Mikkola', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital and Folkhälsan Research Center Biomedicum, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Päivi', 'Initials': 'P', 'LastName': 'Rahkola-Soisalo', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, PO BOX 140, 00029 HUS, Helsinki, Finland.'}, {'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Tulokas', 'Affiliation': 'Doctoral Programme in Clinical Research, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'Maarit', 'Initials': 'M', 'LastName': 'Mentula', 'Affiliation': 'Department of Obstetrics and Gynecology, Helsinki University Hospital, Helsinki University, PO BOX 140, 00029 HUS, Helsinki, Finland. maarit.mentula@hus.fi.'}]",International urogynecology journal,['10.1007/s00192-020-04618-5']
2571,33275112,A Picture Is Worth a Thousand Views: A Triple Crossover Trial of Visual Abstracts to Examine Their Impact on Research Dissemination.,"BACKGROUND
A visual abstract is a graphic summary of a research article's question, methods, and major findings. Although they have a number of uses, visual abstracts are chiefly used to promote research articles on social media.
OBJECTIVE
This study aimed to determine if the use of visual abstracts increases the visibility of nephrology research shared on Twitter.
METHODS
A prospective case-control crossover study was conducted using 40 research articles published in the American Journal of Nephrology (AJN). Each article was shared by the AJN Twitter account in 3 formats: (1) the article citation, (2) the citation with a key figure from the article, and (3) the citation with a visual abstract. Tweets were spaced 2 weeks apart to allow washout of the previous tweet, and the order of the tweets was randomized. Dissemination was measured via retweets, views, number of link clicks, and Altmetric scores.
RESULTS
Tweets that contained a visual abstract had more than twice as many views as citation-only tweets (1351, SD 1053 vs 639, SD 343) and nearly twice as many views as key figure tweets (1351, SD 1053 vs 732, SD 464). Visual abstract tweets had 5 times the engagements of citation-only tweets and more than 3.5 times the engagements of key figure tweets. Visual abstract tweets were also associated with greater increases in Altmetric scores as compared to citation-only tweets (2.20 vs 1.05).
CONCLUSIONS
The use of visual abstracts increased visibility of research articles on Twitter, resulting in a greater number of views, engagements, and retweets. Visual abstracts were also associated with increased Altmetric scores as compared to citation-only tweets. These findings support the broader use of visual abstracts in the scientific community. Journals should consider visual abstracts as valuable tools for research dissemination.",2020,"The use of visual abstracts increased visibility of research articles on Twitter, resulting in a greater number of views, engagements, and retweets.",['40 research articles published in the American Journal of Nephrology (AJN'],[],"['Altmetric scores', 'Dissemination was measured via retweets, views, number of link clicks, and Altmetric scores']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0557714,"The use of visual abstracts increased visibility of research articles on Twitter, resulting in a greater number of views, engagements, and retweets.","[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Oska', 'Affiliation': 'William Beaumont School of Medicine, Oakland University, Rochester, MI, United States.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Lerma', 'Affiliation': 'College of Medicine, University of Illinois at Chicago, Chicago, IL, United States.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Topf', 'Affiliation': 'William Beaumont School of Medicine, Oakland University, Rochester, MI, United States.'}]",Journal of medical Internet research,['10.2196/22327']
2572,33275107,Effects of Goal Type and Reinforcement Type on Self-Reported Domain-Specific Walking Among Inactive Adults: 2×2 Factorial Randomized Controlled Trial.,"BACKGROUND
WalkIT Arizona was a 2×2 factorial trial examining the effects of goal type (adaptive versus static) and reinforcement type (immediate versus delayed) to increase moderate to vigorous physical activity (MVPA) among insufficiently active adults. The 12-month intervention combined mobile health (mHealth) technology with behavioral strategies to test scalable population-health approaches to increasing MVPA. Self-reported physical activity provided domain-specific information to help contextualize the intervention effects.
OBJECTIVE
The aim of this study was to report on the secondary outcomes of self-reported walking for transportation and leisure over the course of the 12-month WalkIT intervention.
METHODS
A total of 512 participants aged 19 to 60 years (n=330 [64.5%] women; n=425 [83%] Caucasian/white, n=96 [18.8%] Hispanic/Latinx) were randomized into interventions based on type of goals and reinforcements. The International Physical Activity Questionnaire-long form assessed walking for transportation and leisure at baseline, and at 6 months and 12 months of the intervention. Negative binomial hurdle models were used to examine the effects of goal and reinforcement type on (1) odds of reporting any (versus no) walking/week and (2) total reported minutes of walking/week, adjusted for neighborhood walkability and socioeconomic status. Separate analyses were conducted for transportation and leisure walking, using complete cases and multiple imputation.
RESULTS
All intervention groups reported increased walking at 12 months relative to baseline. Effects of the intervention differed by domain: a significant three-way goal by reinforcement by time interaction was observed for total minutes of leisure walking/week, whereas time was the only significant factor that contributed to transportation walking. A sensitivity analysis indicated minimal differences between complete case analysis and multiple imputation.
CONCLUSIONS
This study is the first to report differential effects of adaptive versus static goals for self-reported walking by domain. Results support the premise that individual-level PA interventions are domain- and context-specific and may be helpful in guiding further intervention refinement.
TRIAL REGISTRATION
Preregistered at clinicaltrials.gov: (NCT02717663) https://clinicaltrials.gov/ct2/show/NCT02717663.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1016/j.cct.2019.05.001.",2020,"Effects of the intervention differed by domain: a significant three-way goal by reinforcement by time interaction was observed for total minutes of leisure walking/week, whereas time was the only significant factor that contributed to transportation walking.","['insufficiently active adults', 'Inactive Adults', '512 participants aged 19 to 60 years (n=330 [64.5%] women; n=425 [83%] Caucasian/white, n=96 [18.8%] Hispanic/Latinx']","['goal type (adaptive versus static) and reinforcement type (immediate versus delayed', 'Goal Type and Reinforcement Type on Self-Reported Domain-Specific Walking', 'intervention combined mobile health (mHealth) technology with behavioral strategies']",['vigorous physical activity (MVPA'],"[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",512.0,0.0671941,"Effects of the intervention differed by domain: a significant three-way goal by reinforcement by time interaction was observed for total minutes of leisure walking/week, whereas time was the only significant factor that contributed to transportation walking.","[{'ForeName': 'Mindy L', 'Initials': 'ML', 'LastName': 'McEntee', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Cantley', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Foreman', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Berardi', 'Affiliation': 'Department of Psychology, Crean School of Health and Behavioral Sciences, Chapman University, Orange, CA, United States.'}, {'ForeName': 'Christine B', 'Initials': 'CB', 'LastName': 'Phillips', 'Affiliation': 'Atria Senior Living, Louisville, KY, United States.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Hurley', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'College of Health and Human Services, San Diego State University, San Diego, CA, United States.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hooker', 'Affiliation': 'College of Health and Human Services, San Diego State University, San Diego, CA, United States.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Adams', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}]",JMIR formative research,['10.2196/19863']
2573,33275104,Twitter-Based Social Support Added to Fitbit Self-Monitoring for Decreasing Sedentary Behavior: Protocol for a Randomized Controlled Pilot Trial With Female Patients From a Women's Heart Clinic.,"BACKGROUND
Prolonged sitting is an independent risk behavior for the development of chronic disease. With most interventions focusing on physical activity and exercise, there is a separate need for investigation into innovative and accessible interventions to decrease sedentary behavior throughout the day. Twitter is a social media platform with application for health communications and fostering of social support for health behavior change.
OBJECTIVE
This pilot study aims to test the feasibility, acceptability, and preliminary efficacy of delivering daily behavior change strategies within private Twitter groups to foster peer-to-peer support and decrease sedentary behavior throughout the day in women. The Twitter group was combined with a Fitbit for self-monitoring activity and compared to a Fitbit-only control group.
METHODS
In a 2-group design, participants were randomized to a Twitter + Fitbit treatment group or a Fitbit-only control group. Participants were recruited via the Stanford Research Repository System, screened for eligibility, and then invited to an orientation session. After providing informed consent, they were randomized. All participants received 13 weeks of tailored weekly step goals and a Fitbit. The treatment group participants, placed in a private Twitter support group, received daily automated behavior change ""tweets"" informed by theory and regular automated encouragement via text to communicate with the group. Fitbit data were collected daily throughout the treatment and follow-up period. Web-based surveys and accelerometer data were collected at baseline, treatment end (13 weeks), and at 8.5 weeks after the treatment.
RESULTS
The initial study design funding was obtained from the Women's Heart Clinic and the Stanford Clayman Institute. Funding to run this pilot study was received from the National Institutes of Health's National Heart, Lung, and Blood Institute under Award Number K01HL136702. All procedures were approved by Stanford University's Institutional Review Board, #32127 in 2018, prior to beginning data collection. Recruitment for this study was conducted in May 2019. Of the 858 people screened, 113 met the eligibility criteria, 68 came to an information session, and 45 consented to participate in this pilot study. One participant dropped out of the intervention, and complete follow-up data were obtained from 39 of the 45 participants (87% of the sample). Data were collected over 6 months from June to December 2019. Feasibility, acceptability, and preliminary efficacy results are being analyzed and will be reported in the winter of 2021.
CONCLUSIONS
This pilot study is assessing the feasibility, acceptability, and preliminary efficacy of delivering behavior change strategies in a Twitter social support group to decrease sedentary behavior in women. These findings will inform a larger evaluation. With an accessible, tailorable, and flexible platform, Twitter-delivered interventions offer potential for many treatment variations and titrations, thereby testing the effects of different behavior change strategies, peer-group makeups, and health behaviors of interest.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02958189, https://clinicaltrials.gov/ct2/show/NCT02958189.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/20926.",2020,"This pilot study is assessing the feasibility, acceptability, and preliminary efficacy of delivering behavior change strategies in a Twitter social support group to decrease sedentary behavior in women.","['Sedentary Behavior', 'women', 'private Twitter groups to foster peer-to-peer support and decrease sedentary behavior throughout the day in women', ""Women's Heart Clinic and the Stanford Clayman Institute"", 'Female Patients', '858 people screened, 113 met the eligibility criteria, 68 came to an information session, and 45 consented to participate in this pilot study', 'Participants were recruited via the Stanford Research Repository System, screened for eligibility, and then invited to an orientation session']","['Twitter + Fitbit treatment group or a Fitbit-only control group', 'Twitter-Based Social Support Added to Fitbit Self-Monitoring', 'private Twitter support group, received daily automated behavior change ""tweets"" informed by theory and regular automated encouragement via text to communicate with the group']",['sedentary behavior'],"[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.0496426,"This pilot study is assessing the feasibility, acceptability, and preliminary efficacy of delivering behavior change strategies in a Twitter social support group to decrease sedentary behavior in women.","[{'ForeName': 'Marily', 'Initials': 'M', 'LastName': 'Oppezzo', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Tremmel', 'Affiliation': ""Interventional Cardiology, Women's Heart Health at Stanford, Stanford, CA, United States.""}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Science Unit, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baiocchi', 'Affiliation': 'Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cullen', 'Affiliation': 'Primary Care and Population Health, Stanford University School of Medicine, Stanford, CA, United States.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, CA, United States.'}]",JMIR research protocols,['10.2196/20926']
2574,33275096,Compression stockings in addition to low-molecular-weight heparin to prevent venous thromboembolism in surgical inpatients requiring pharmacoprophylaxis: the GAPS non-inferiority RCT.,"BACKGROUND
Patients admitted to hospital for surgery are at an increased risk of venous thromboembolism. Pharmaco-thromboprophylaxis and mechanical prophylaxis (usually graduated compression stockings or intermittent pneumatic compression) have been shown to reduce the incidence of venous thromboembolism. The evidence base supporting the National Institute for Health and Care Excellence's recommendation for the use of graduated compression stockings for venous thromboembolism prevention in the UK has recently been challenged. It is unclear if the risks and costs associated with graduated compression stockings are justified for deep-vein thrombosis prevention in moderate- and high-risk elective surgical inpatients receiving low-dose low-molecular-weight heparin pharmaco-thromboprophylaxis.
OBJECTIVES
The primary objective was to compare the venous thromboembolism rate in elective surgical inpatients at moderate or high risk of venous thromboembolism who were receiving either graduated compression stockings and low-dose low-molecular-weight heparin (standard care) or low-dose low-molecular-weight heparin alone (intervention).
DESIGN
This was a pragmatic, multicentre, prospective, non-inferiority, randomised controlled trial.
SETTING
This took place in secondary care NHS hospitals in the UK.
PARTICIPANTS
Patients aged ≥ 18 years who were assessed to be at moderate or high risk of venous thromboembolism according to the NHS England venous thromboembolism risk assessment tool (or the trust equivalent based on this form) and who were not contraindicated to low-molecular-weight heparin or graduated compression stockings were deemed eligible to take part.
INTERVENTIONS
Participants were randomised 1 : 1 to either low-molecular-weight heparin or low-molecular-weight heparin and graduated compression stockings.
MAIN OUTCOME MEASURES
The primary outcome measure was venous thromboembolism up to 90 days after surgery. A combined end point of duplex ultrasound-proven new lower-limb deep-vein thrombosis (symptomatic or asymptomatic) plus imaging-confirmed symptomatic pulmonary embolism. Secondary outcomes included quality of life, compliance with graduated compression stockings and low-molecular-weight heparin during admission, and all-cause mortality.
RESULTS
A total of 1905 participants were randomised and 1858 were included in the intention-to-treat analysis. A primary outcome event occurred in 16 out of 937 (1.7%) patients in the low-molecular-weight heparin-alone arm compared with 13 out of 921 (1.4%) patients in the low-molecular-weight heparin plus graduated compression stockings arm. The risk difference between low-molecular-weight heparin and low-molecular-weight heparin plus graduated compression stockings was 0.30% (95% confidence interval -0.65% to 1.26%). As the 95% confidence interval did not cross the non-inferiority margin of 3.5% ( p < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown.
LIMITATIONS
In total, 13% of patients did not receive a duplex ultrasound scan that could have detected further asymptomatic deep-vein thrombosis. However, missing scans were balanced between both trial arms. The subpopulation of those aged ≥ 65 years assessed as being at a moderate risk of venous thromboembolism was under-represented in the study; however, this reflects that this group is under-represented in the general population.
CONCLUSIONS
For elective surgical patients at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and graduated compression stockings. These findings indicate that graduated compression stockings may be unnecessary for most elective surgical patients.
FUTURE WORK
Further studies are required to evaluate whether or not adjuvant graduated compression stockings have a role in patients receiving extended thromboprophylaxis, beyond the period of hospital admission, following elective surgery or in patients undergoing emergency surgical procedures.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN13911492.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 69. See the NIHR Journals Library website for further project information.",2020,"As the 95% confidence interval did not cross the non-inferiority margin of 3.5% ( p < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown.
","['patients receiving extended thromboprophylaxis, beyond the period of hospital admission, following elective surgery or in patients undergoing emergency surgical procedures', 'Patients aged ≥\u200918 years who were assessed to be at moderate or high risk of venous thromboembolism according to the NHS England venous thromboembolism risk assessment tool (or the trust equivalent based on this form) and who were not contraindicated to low-molecular-weight heparin or graduated compression stockings were deemed eligible to take part', 'elective surgical inpatients at moderate or high risk of venous thromboembolism who were receiving either', 'A total of 1905 participants were randomised and 1858 were included in the intention-to-treat analysis', 'moderate- and high-risk elective surgical inpatients receiving low-dose low-molecular-weight heparin pharmaco-thromboprophylaxis', 'surgical inpatients requiring pharmacoprophylaxis', 'elective surgical patients at moderate or high risk of venous thromboembolism']","['duplex ultrasound scan', 'graduated compression stockings', 'Pharmaco-thromboprophylaxis and mechanical prophylaxis (usually graduated compression stockings or intermittent pneumatic compression', 'Compression stockings', 'graduated compression stockings and low-dose low-molecular-weight heparin (standard care) or low-dose low-molecular-weight heparin alone (intervention', 'low-molecular-weight heparin or low-molecular-weight heparin and graduated compression stockings', 'duplex ultrasound-proven new lower-limb deep-vein thrombosis (symptomatic or asymptomatic) plus imaging']","['venous thromboembolism rate', 'moderate risk of venous thromboembolism', 'asymptomatic deep-vein thrombosis', 'venous thromboembolism', 'quality of life, compliance with graduated compression stockings and low-molecular-weight heparin during admission, and all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0332166', 'cui_str': 'Moderate risk of'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0038348', 'cui_str': 'Compression stocking'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0585045', 'cui_str': 'During admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1905.0,0.19843,"As the 95% confidence interval did not cross the non-inferiority margin of 3.5% ( p < 0.001 for non-inferiority), the results indicate that non-inferiority of low-molecular-weight heparin alone was shown.
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shalhoub', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lawton', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Department of Surgery and Cancer, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bradbury', 'Affiliation': 'College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dhillon', 'Affiliation': 'Department of Surgery and Cancer, Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Everington', 'Affiliation': 'Department of Haematology, Hampshire Hospitals NHS Foundation Trust, Basingstoke, UK.'}, {'ForeName': 'Manjit S', 'Initials': 'MS', 'LastName': 'Gohel', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Zaed', 'Initials': 'Z', 'LastName': 'Hamady', 'Affiliation': 'Southampton HPB Unit, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Beverly J', 'Initials': 'BJ', 'LastName': 'Hunt', 'Affiliation': ""Department of Thrombosis and Haemostasis, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Stansby', 'Affiliation': 'Northern Vascular Unit, Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warwick', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Alun H', 'Initials': 'AH', 'LastName': 'Davies', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, London, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24690']
2575,33275087,"Video-Assisted Modified Ligation of the Intersphincteric Fistula Tract, an Integration of 2 Minimally Invasive Techniques for the Treatment of Parks Type II Anal Fistulas.","Introduction. Complex anal fistula (CAF) is a challenging anorectal condition. Although numerous treatments for its management have been proposed, none is ideal. Herein, we investigated the clinical efficacy of video-assisted modified ligation of the intersphincteric fistula tract (LIFT) in comparison with the incision-thread-drawing procedure for Parks type II anal fistulas. Methods. Male and female adult patients with Parks type II anal fistula who were randomized to receive one of two procedures in the Anorectal Surgery Unit of the Affiliated People's Hospital of Ningbo University: video-assisted modified LIFT (test group, 30 cases) or incision thread drawing (control group, 30 cases). Healing and recurrence, postoperative pain, and postoperative autonomous anal control ability were compared. Results. In the test group, the pain scores were significantly lower ( P = .001) and wound healing was faster ( P = .001). However, there were no marked differences between groups in operative efficacy or postoperative infection rate (all P > .05). We followed all the patients for more than 18 months, with the test group having lower Jorge-Wexner incontinence ( P = .005) and fecal incontinence (FI) severity index ( P = .000) scores. No significant difference in recurrence ( χ 2 = .351, P = .554) or healing ( χ 2 = 1.071, P = .301) rate was found between the 2 groups. Conclusions. We established that video-assisted modified LIFT is superior in repairing Parks type II anal fistulas, with less trauma, quicker recovery, and better anal function.",2020,"In the test group, the pain scores were significantly lower ( P = .001) and wound healing was faster (","['Parks Type II Anal Fistulas', 'Parks type II anal fistulas', ""Male and female adult patients with Parks type II anal fistula who were randomized to receive one of two procedures in the Anorectal Surgery Unit of the Affiliated People's Hospital of Ningbo University""]","['Video-Assisted Modified Ligation of the Intersphincteric Fistula Tract', 'Complex anal fistula (CAF', 'video-assisted modified LIFT', 'video-assisted modified ligation of the intersphincteric fistula tract (LIFT', 'video-assisted modified LIFT (test group, 30 cases) or incision thread drawing (control', 'incision-thread-drawing procedure']","['recurrence', 'healing', 'wound healing', 'operative efficacy or postoperative infection rate', 'Jorge-Wexner incontinence', 'Healing and recurrence, postoperative pain, and postoperative autonomous anal control ability', 'pain scores', 'fecal incontinence (FI) severity index']","[{'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0149889', 'cui_str': 'Anorectal fistula'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0341379', 'cui_str': 'Intersphincteric fistula'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0149889', 'cui_str': 'Anorectal fistula'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0354737,"In the test group, the pain scores were significantly lower ( P = .001) and wound healing was faster (","[{'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Wu', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}, {'ForeName': 'Bi-Chun', 'Initials': 'BC', 'LastName': 'Zheng', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Chen', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}, {'ForeName': 'Shao-Shun', 'Initials': 'SS', 'LastName': 'Ye', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}, {'ForeName': 'Qiao-Yun', 'Initials': 'QY', 'LastName': 'Lin', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}, {'ForeName': 'Neng-Hong', 'Initials': 'NH', 'LastName': 'Ye', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Rong', 'Affiliation': ""Division of General Surgery, The Affiliated People' Hospital of Ningbo University, Ningbo, Zhejiang, China.""}]",Surgical innovation,['10.1177/1553350620978026']
2576,33271502,Self-Selecting the Number of Repetitions in Potentiation Protocols: Enhancement Effects on Jumping Performance.,"PURPOSE
To investigate whether providing athletes with a choice regarding the number of repetitions to complete in a potentiation protocol would enhance jumping performance compared with protocols in which the number of repetitions is predetermined.
METHODS
Fifteen male basketball players completed 4 testing sessions separated by 72 hours. In the first session, individual optimum power loads in the barbell jump squat were determined. In the following 3 sessions, the athletes completed 3 sets of 3 potentiation protocols using optimum power load jump squats in a partly randomized order: (1) The traditional condition included 6 repetitions per set, (2) the self-selected condition included a choice regarding the number of repetitions to complete per set, and (3) the imposed condition included the same number of repetitions per set as the self-selected condition, but the number was imposed on the athletes beforehand. The jumping performance was determined as jump squat test height and measured using a force platform before and 30 seconds, 4 minutes, and 8 minutes after completing the protocols.
RESULTS
The self-selected condition led to superior jumping performance compared with the 2 other conditions across all post measures (P < .05; range: 0.3-1.3 cm). Compared with the traditional condition, the imposed condition led to superior jumping performance across all post measures (range: 0.2-0.45 cm), although not statistically significant at post 4 minutes and post 8 minutes.
CONCLUSIONS
Choice provision concerning how many repetitions to complete in a potentiation protocol is a useful performance-enhancing strategy. Improved potentiation-fatigue ratio and motivational factors are sought to explain these effects.",2020,The self-selected condition led to superior jumping performance compared with the 2 other conditions across all post measures (P < .05; range: 0.3-1.3 cm).,['Fifteen male basketball players completed 4 testing sessions separated by 72 hours'],"['traditional condition included 6 repetitions per set, (2)\xa0the self-selected condition included a choice regarding the number of repetitions to complete per set, and (3)\xa0the imposed condition included the same number of repetitions per set as the self-selected condition']",['potentiation-fatigue ratio and motivational factors'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",15.0,0.0294959,The self-selected condition led to superior jumping performance compared with the 2 other conditions across all post measures (P < .05; range: 0.3-1.3 cm).,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Dello Iacono', 'Affiliation': ''}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Beato', 'Affiliation': ''}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Halperin', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0926']
2577,33271498,The Effects of Aerobic Versus Cognitively Demanding Exercise Interventions on Executive Functioning in School-Aged Children: A Cluster-Randomized Controlled Trial.,"The authors performed a clustered randomized controlled trial to investigate the effects of an aerobic and a cognitively demanding exercise intervention on executive functions in primary-school-age children compared with the regular physical education program (N = 856). They hypothesized that both exercise interventions would facilitate executive functioning, with stronger effects for the cognitively demanding exercise group. The interventions were provided four times per week for 14 weeks. Linear mixed models were conducted on posttest neurocognitive function measures with baseline level as covariate. No differences were found between the exercise interventions and the control group for any of the measures. Independently of group, dose of moderate to vigorous physical activity was positively related to verbal working memory and attention abilities. This study showed that physical exercise interventions did not enhance executive functioning in children. Exposure to moderate to vigorous physical activity is a crucial aspect of the relationship between physical activity and executive functioning.",2020,No differences were found between the exercise interventions and the control group for any of the measures.,"['School-Aged Children', 'children', 'N = 856', 'primary-school-age children']","['aerobic and a cognitively demanding exercise intervention', 'Aerobic Versus Cognitively Demanding Exercise Interventions', 'regular physical education program', 'exercise interventions', 'physical exercise interventions']","['Executive Functioning', 'executive functioning', 'verbal working memory and attention abilities', 'vigorous physical activity', 'executive functions']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517894', 'cui_str': '856'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",856.0,0.0381021,No differences were found between the exercise interventions and the control group for any of the measures.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Meijer', 'Affiliation': 'Vrije Universiteit Amsterdam.'}, {'ForeName': 'Marsh', 'Initials': 'M', 'LastName': 'Königs', 'Affiliation': 'University of Amsterdam.'}, {'ForeName': 'Irene M J', 'Initials': 'IMJ', 'LastName': 'van der Fels', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Visscher', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Bosker', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hartman', 'Affiliation': 'University of Groningen.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': 'Vrije Universiteit Amsterdam.'}]",Journal of sport & exercise psychology,['10.1123/jsep.2020-0034']
2578,33271482,Anodal transcranial direct current stimulation in chronic migraine and medication overuse headache: A pilot double-blind randomized sham-controlled trial.,"OBJECTIVES
Little evidence is available on the role of transcranial direct current stimulation (tDCS) in patients affected by chronic migraine (CM) and medication overuse headache (MOH). We aim to investigate the effects of tDCS in patients with CM and MOH as well as its role on brain activity.
METHODS
Twenty patients with CM and MOH were hospitalized for a 7-day detoxification treatment. Upon admission, patients were randomly assigned to anodal tDCS or sham stimulation delivered over the primary motor cortex contralateral to the prevalent migraine pain side every day for 5 days. Clinical data were recorded at baseline (T0), after 1 month (T2) and 6 months (T3). EEG recording was performed at T0, at the end of the tDCS/Sham treatment, and at T2.
RESULTS
At T2 and T3, we found a significant reduction in monthly migraine days (p = 0.001), which were more pronounced in the tDCS group when compared to the sham group (p = 0.016). At T2, we found a significant increase of alpha rhythm in occipital leads, which was significantly higher in tDCS group when compared to sham group.
CONCLUSIONS
tDCS showed adjuvant effects to detoxification in the management of patients with CM and MOH. The EEG recording showed a significant potentiation of alpha rhythm, which may represent a correlate of the underlying changes in cortico-thalamic connections.
SIGNIFICANCE
This study suggests a possible role for tDCS in the treatment of CM and MOH. The observed clinical improvement is coupled with a potentiation of EEG alpha rhythm.",2020,"At T2, we found a significant increase of alpha rhythm in occipital leads, which was significantly higher in tDCS group when compared to sham group.
","['Twenty patients with CM and MOH were hospitalized for a 7-day detoxification treatment', 'chronic migraine and medication overuse headache', 'patients with CM and MOH', 'patients affected by chronic migraine (CM) and medication overuse headache (MOH']","['anodal tDCS or sham stimulation delivered over the primary motor cortex contralateral to the prevalent migraine pain side every day for 5\xa0days', 'transcranial direct current stimulation (tDCS', 'Anodal transcranial direct current stimulation', 'tDCS']","['monthly migraine days', 'alpha rhythm in occipital leads']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0522254', 'cui_str': 'Analgesic overuse headache'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002219', 'cui_str': 'Alpha Rhythm'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",20.0,0.105726,"At T2, we found a significant increase of alpha rhythm in occipital leads, which was significantly higher in tDCS group when compared to sham group.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'De Icco', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy. Electronic address: roberto.deicco@mondino.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Putortì', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'De Paoli', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cremascoli', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy; Unit of Sleep Medicine and Epilepsy, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Terzaghi', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy; Unit of Sleep Medicine and Epilepsy, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Toscano', 'Affiliation': 'Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy; Stroke Unit, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Allena', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Martinelli', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Cosentino', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Grillo', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Colagiorgio', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Versino', 'Affiliation': 'Neurology and Stroke Unit, Circolo Hospital and Macchi Foundation, Varese, Italy; DMC Department, Insubria University, Varese, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Manni', 'Affiliation': 'Unit of Sleep Medicine and Epilepsy, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sances', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sandrini', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Tassorelli', 'Affiliation': 'Headache Science & Neurorehabilitation Center, IRCCS Mondino Foundation, Pavia, Italy; Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.10.014']
2579,33271398,Effects of violent video games on players' and observers' aggressive cognitions and aggressive behaviors.,"Although previous research has shown that exposure to violent video games is related to aggression, little is known about the relationship between the player's perspective (player vs. observer) and aggression. In this experimental study, we tested the short-term effects of actively playing versus passively observing the same type of video games on aggressive cognitions and aggressive behaviors. A total of 192 12-year-old children (50% girls) were randomly assigned to one of four conditions: (a) violent game player (active violent players), (b) violent game observer (passive violent observers), (c) neutral game player (active neutral players), or (d) neutral game observer (passive neutral observers). After either playing or observing the designated games, each participant completed a lexical decision task and a competitive reaction time task to measure their aggressive cognitions and behaviors. Results showed that players displayed more aggressive cognitions and behaviors than observers. Boys displayed more aggressive cognitions and behaviors than girls, but this trend was observed only in the violent game play condition. Mediational analysis suggested that aggressive cognitions partially mediated the effect of violent video games on aggressive behaviors.",2020,"Boys displayed more aggressive cognitions and behaviors than girls, but this trend was observed only in the violent game play condition.",['192 12-year-old children (50% girls'],"['violent video games', 'actively playing versus passively observing the same type of video games', 'violent game player (active violent players), (b) violent game observer (passive violent observers), (c) neutral game player (active neutral players), or (d) neutral game observer (passive neutral observers', 'lexical decision task and a competitive reaction time task']","['aggressive cognitions and behaviors', ""players' and observers' aggressive cognitions and aggressive behaviors"", 'aggressive cognitions and aggressive behaviors', 'aggressive behaviors']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.140645,"Boys displayed more aggressive cognitions and behaviors than girls, but this trend was observed only in the violent game play condition.","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Center for Studies of Education and Psychology of Minorities in Southwest China, Southwest University, Chongqing 400715, China; Faculty of Education, Southwest University, Chongqing 400715, China. Electronic address: 453457096@qq.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Faculty of Education, Southwest University, Chongqing 400715, China; The Third Kindergarten in Chengdu, Sichuan 610016, China.'}, {'ForeName': 'JingJin', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Faculty of Education, Southwest University, Chongqing 400715, China; The Dawn and Innovation Kindergarten, Chongqing 400030, China.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2020.105005']
2580,33271298,"Effect of hypocaloric high-protein, low-carbohydrate diet supplemented with fennel on androgenic and anthropometric indices in overweight and obese women with polycystic ovary syndrome: a randomized placebo-controlled trial.","OBJECTIVE
The aim of this study was to evaluate the effect of hypocaloric high-protein, low-carbohydrate weight loss diet supplemented with fennel on anthropometric and androgen indices in overweight and obese women with polycystic ovary syndrome (PCOS).
METHODS
A randomized controlled trial with a factorial design was performed on sixty-four overweight/obese women with PCOS. Participants were randomly allocated to four groups (n = 16 per group) as follows: 1) hypocaloric standardize diet + fennel (2 capsule/day) (HSDF), 2) hypocaloric high-protein diet + fennel (2 capsule/day) (HHPF), 3) hypocaloric standardize diet + placebo (HSDP), and 4) hypocaloric high-protein diet + placebo (HHPP).
RESULTS
The mean (SD) age of the participants was 28.54 (6.80) years and body mass index was 32.24 (4.65) kg/m 2 . At the end of intervention, protein intake was 20.43% in the groups that received a high-protein diet versus 16.37% in the standard diet groups (P < 0.001). Combination of hypocaloric high-protein diet and fennel capsule did not significantly affect change in outcomes compared with groups not receiving them. There was a significant interaction between hypocaloric high-protein diet and fennel on weight (P = 0.019).
CONCLUSION
A hypocaloric high-protein diet along with fennel supplementation could not provide additional improvements in anthropometric and androgen indices among PCOS women. Further studies are required to more precisely elucidate these findings.",2020,Combination of hypocaloric high-protein diet and fennel capsule did not significantly affect change in outcomes compared with groups not receiving them.,"['overweight and obese women with polycystic ovary syndrome (PCOS', 'PCOS women', 'sixty-four overweight/obese women with PCOS', 'overweight and obese women with polycystic ovary syndrome']","['hypocaloric standardize diet\u2009+\u2009fennel (2 capsule/day) (HSDF), 2) hypocaloric high-protein diet\u2009+\u2009fennel (2 capsule/day) (HHPF), 3) hypocaloric standardize diet\u2009+\u2009placebo (HSDP), and 4) hypocaloric high-protein diet\u2009+\u2009placebo (HHPP', 'placebo', 'hypocaloric high-protein, low-carbohydrate diet supplemented with fennel', 'hypocaloric high-protein, low-carbohydrate weight loss diet supplemented with fennel', 'fennel supplementation', 'hypocaloric high-protein diet and fennel capsule']","['protein intake', 'anthropometric and androgen indices', 'androgenic and anthropometric indices']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C4517839', 'cui_str': '64'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015833', 'cui_str': 'Fennel extract'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0002844', 'cui_str': 'Androgen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",64.0,0.109409,Combination of hypocaloric high-protein diet and fennel capsule did not significantly affect change in outcomes compared with groups not receiving them.,"[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Nadjarzadeh', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Ghadiri-Anari', 'Affiliation': 'Department of Internal Medicine, Diabetes Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Ramezani-Jolfaie', 'Affiliation': 'Department of Community Medicine, School of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Community Medicine, School of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Amin Salehi', 'Initials': 'AS', 'LastName': 'Abargouei', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyedeh Mahdieh', 'Initials': 'SM', 'LastName': 'Namayande', 'Affiliation': 'Yazd Cardiovascular Research Center, Shahid Sadoughi University of Medical Sciences and Health Services, Yazd, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Elham Hosseini', 'Initials': 'EH', 'LastName': 'Marnani', 'Affiliation': 'Nutrition and Food Security Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran; Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: Elham_Hosseini1993@yahoo.com.'}]",Complementary therapies in medicine,['10.1016/j.ctim.2020.102633']
2581,32075507,Intravenous lidocaine affects oxaliplatin pharmacokinetics in simultaneous infusion.,"BACKGROUND
Oxaliplatin is a chemotherapeutic agent used to treat malignancies of the gastrointestinal tract. Neuropathy is a frequent dose-limiting side-effect of oxaliplatin therapy, without preventive or curative strategies. Concomitant administration of intravenous lidocaine could be a promising treatment. However, the effect of intravenous lidocaine on oxaliplatin pharmacokinetics was never studied before. We evaluated the effect of lidocaine on the area under the curve and C max of oxaliplatin as a part of a larger study addressing the prevention and treatment of oxaliplatin induced peripheral neuropathy with lidocaine.
METHODS
In this prospective cross-over trial, patients received an oxaliplatin cycle with and without lidocaine (bolus 1.5 mg kg -1 followed by 1.5 mg kg -1 h -1 in 3 h). Levels of oxaliplatin, measured as ultrafiltrable platinum were determined at 10 min after cessation of oxaliplatin infusion and hourly thereafter. Outcomes are the difference in area under the curve of oxaliplatin (primary) and the difference in the C max of oxaliplatin (secondary).
RESULTS
No difference in the %Δ area under the curve of oxaliplatin (-2.40 ± 7.66, 90% CI +10.50 to -15.31) was found. However, %Δ C max of oxaliplatin (-28.72 ± 6.01, 90% CI -18.59 to -38.85) was lower to a statistically significant extent in the chemotherapy cycle with lidocaine. No (serious) adverse events were reported.
CONCLUSIONS
Lidocaine does not affect the area under the curve of oxaliplatin, which is the most important parameter in drug interaction studies and for oxaliplatin treatment effect. The lower C max in the chemotherapeutic cycle with lidocaine is significant and remarkable, but with an unknown exact mechanism or clinical significance, making further research desirable.",2020,"No difference in the %Δ area under the curve of oxaliplatin (-2.40 ± 7.66, 90% CI +10.50 to -15.31) was found.",[],"['oxaliplatin cycle with and without lidocaine', 'oxaliplatin', 'lidocaine', 'oxaliplatin therapy', 'Oxaliplatin', 'Lidocaine']","['No (serious) adverse events', 'area under the curve of oxaliplatin (primary) and the difference in the C max of oxaliplatin (secondary', 'oxaliplatin pharmacokinetics']",[],"[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0405975,"No difference in the %Δ area under the curve of oxaliplatin (-2.40 ± 7.66, 90% CI +10.50 to -15.31) was found.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'van Haren', 'Affiliation': 'Department of Anesthesiology Pain and Palliative Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Anesthesiology Pain and Palliative Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Radema', 'Affiliation': 'Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Nielka', 'Initials': 'N', 'LastName': 'van Erp', 'Affiliation': 'Department of Pharmacology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Luuk', 'Initials': 'L', 'LastName': 'van den Bersselaar', 'Affiliation': 'Department of Anesthesiology Pain and Palliative Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Vissers', 'Affiliation': 'Department of Anesthesiology Pain and Palliative Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Steegers', 'Affiliation': 'Department of Anesthesiology Pain and Palliative Medicine, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}]",Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners,['10.1177/1078155220905011']
2582,33278071,Lung deposition and systemic bioavailability of dose delivered to smoker compared to non-smoker COPD subjects.,"INTRODUCTION
Inhaled drugs are the most commonly used class of medications for COPD subjects. No studies have been performed to assess the influence of smoking on lung deposition of aerosolized medication, especially for the exacerbated COPD subject. The present study aimed to assess the influence of smoking on the lung deposition of the aerosol delivered to exacerbated COPD subjects.
METHODS
Twenty-four exacerbated COPD subjects using automatic continuous positive airway pressure (Auto-CPAP), twelve smokers (six females), and twelve non-smokers (six females) were recruited in the study. The subjects participated in the study received four salbutamol study doses; 1200µg (12 puffs 100 µg/puff) of salbutamol emitted from pMDI canister connected to AeroChamber MV spacer; 1200µg of salbutamol emitted from pMDI canister connected to Combihaler spacer; 1 ml of salbutamol respirable solution (5000 µg/ml) nebulized by Aerogen Solo connected to its T-piece; and 1 ml of salbutamol respirable solution nebulized by Aerogen Solo connected to Combihaler spacer with 2 puffs salbutamol MDI (200µg salbutamol) before nebulization. The subjects were randomized to receive the four selected dose-adaptor combination in a sealed envelope design on days 1, 3, 5, and 7. A washout period of 24 h was provided between each salbutamol dosing. Auto-CPAP was adjusted at non-invasive ventilation mode with the integrated heated humidifier, as a source of humidity. Urine samples were provided by subjects, 30 minutes and cumulatively 24 hours post inhalation, as an index of the relative and systemic bioavailability respectively, and aliquots were retained for salbutamol analysis using solid-phase extraction and high-performance liquid chromatography (HPLC). On day 2 of the study, a collecting filter was placed between the aerosol generator and the subject's mask so that the subjects would not inhale the salbutamol delivered. The same study doses and/or adapters were delivered to each subject, with filters changed with each dose-adapter combination. Salbutamol entrained on the filter was desorbed to be analyzed by the HPLC.
RESULTS
Significantly higher lung deposition (30 minutes urinary salbutamol) was detected with the non-smoker compared to smokers (p<0.05). Significantly higher systemic bioavailability (pooled 24-hour urinary salbutamol) for smokers compared to non-smokers was found with Aerogen Solo connected to its T-piece and CombiHaler spacer with pMDI (p<0.05) only. Significantly higher amount desorbed from the ex-vivo filter were found from pMDI with both spacers in non-smokers (p<0.05) compared to the smokers.
CONCLUSION
The study demonstrated that smoking reduced the lung deposition of inhaled salbutamol delivered by nebulizer or pMDI. However, the smoking effect on cytochrome p450 was observed to increase systemic absorption of the ingested portion of the inhaled dose. The lower lung deposition and possible higher systemic absorption should be taken into consideration while prescribing inhaled medication to COPD smokers especially exacerbated patients that need ventilation. Further studies are needed.",2020,Significantly higher lung deposition (30 minutes urinary salbutamol) was detected with the non-smoker compared to smokers (p<0.05).,"['non-smoker COPD subjects', 'Twenty-four exacerbated COPD subjects using automatic continuous positive airway pressure (Auto-CPAP), twelve smokers (six females), and twelve non-smokers (six females) were recruited in the study', 'COPD subjects']","['Salbutamol', 'salbutamol emitted from pMDI canister connected to AeroChamber MV spacer; 1200µg of salbutamol emitted from pMDI canister connected to Combihaler spacer; 1 ml of salbutamol respirable solution (5000 µg/ml) nebulized by Aerogen Solo connected to its T-piece; and 1 ml of salbutamol respirable solution nebulized by Aerogen Solo connected to Combihaler spacer with 2 puffs salbutamol MDI']","['systemic bioavailability', 'systemic absorption', 'Lung deposition and systemic bioavailability', 'lung deposition of inhaled salbutamol', 'lower lung deposition', 'lung deposition']","[{'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0336640', 'cui_str': 'Canister'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4319610', 'cui_str': '5000'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C3850076', 'cui_str': 'Absorption, Systemic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",24.0,0.015108,Significantly higher lung deposition (30 minutes urinary salbutamol) was detected with the non-smoker compared to smokers (p<0.05).,"[{'ForeName': 'Basma M E', 'Initials': 'BME', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacy Department Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Randa', 'Initials': 'R', 'LastName': 'Salah Eldin', 'Affiliation': 'Chest Department Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Salah Eldin', 'Affiliation': 'Chest Department Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed E A', 'Initials': 'MEA', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Raghda R S', 'Initials': 'RRS', 'LastName': 'Hussein', 'Affiliation': 'Clinical Pharmacy Department Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}]",International journal of clinical practice,['10.1111/ijcp.13883']
2583,33278048,Clinical and histological comparison of the soft tissue morphology between zirconia and titanium dental implants under healthy and experimental mucositis conditions - A randomized controlled clinical trial.,"OBJECTIVES
To analyze the soft tissue morphology under healthy and experimental mucositis conditions comparing zirconia and titanium implants.
METHODS
Forty-two patients with two adjacent missing teeth received one zirconia (Zr) and one titanium (Ti) implant, with the mesial and distal position randomized. At 3 months, half of the patients were instructed to continue (healthy; h) and the other half to omit (experimental mucositis; m) oral hygiene around the implants for 3 weeks. Clinical parameters were evaluated before and after the experimental phase and a soft tissue biopsy was harvested. Mixed model analyses were performed to analyze the data.
RESULTS
The plaque control record increased significantly for the two mucositis groups, reaching 68.3±31.9% (mean±standard deviation) for Zr-m and 75.0±29.4% for Ti-m (p<0.0001), being also significantly lower for Zr-m than for Ti-m. Bleeding on probing remained stable in group Zr-m and amounted to 21.7±23.6%, but increased significantly in group Ti-m (p=0.040), measuring 32.5±27.8%. The number of inflammatory cells and the length of the junctional epithelium did not significantly differ between the groups.
CONCLUSION
Both implants rendered similar outcomes under healthy conditions. Lower plaque and bleeding scores were detected for zirconia implants under experimental mucositis conditions. Histologically, only minimal differences were observed.",2020,"The plaque control record increased significantly for the two mucositis groups, reaching 68.3±31.9% (mean±standard deviation) for Zr-m and 75.0±29.4% for Ti-m (p<0.0001), being also significantly lower for Zr-m than for Ti-m.","['Forty-two patients with two adjacent missing teeth received one', 'zirconia and titanium dental implants under healthy and experimental mucositis conditions']","['zirconia and titanium implants', 'zirconia (Zr) and one titanium (Ti) implant']","['Lower plaque and bleeding scores', 'number of inflammatory cells and the length of the junctional epithelium', 'Bleeding on probing', 'plaque control']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014596', 'cui_str': 'Junctional Epithelium'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",42.0,0.0206867,"The plaque control record increased significantly for the two mucositis groups, reaching 68.3±31.9% (mean±standard deviation) for Zr-m and 75.0±29.4% for Ti-m (p<0.0001), being also significantly lower for Zr-m than for Ti-m.","[{'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Bienz', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Hilbe', 'Affiliation': 'Institute of Veterinary Pathology, Vetsuisse Faculty, Zurich, Switzerland.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Hüsler', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Thoma', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christoph H F', 'Initials': 'CHF', 'LastName': 'Hämmerle', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ronald E', 'Initials': 'RE', 'LastName': 'Jung', 'Affiliation': 'Clinic of Reconstructive Dentistry, University of Zurich, Zurich, Switzerland.'}]",Journal of clinical periodontology,['10.1111/jcpe.13411']
2584,33278026,Supporting pre-service teachers' motivation beliefs and approaches to instruction through an online intervention.,"BACKGROUND
Previous research has shown that pre-service teachers have low responsibility for student motivation and feel underprepared to deal with motivational issues. As an extension, researchers have designed interventions to shift teachers' beliefs about motivation or equip them with approaches to instruction, but never both.
AIMS
Following best practices for motivation interventions, we created a one-session online intervention and tested its efficacy to shift pre-service teachers' self-reported beliefs and approaches to instruction to be more supportive of student motivation. The intervention included priming, materials designed for mindsets and/or for approaches to instruction, a consolidation activity, and take-home materials.
SAMPLE
A convenience sample of 384 pre-service teachers from one Canadian university participated.
METHODS
We embedded an experimental design into multiple sections of a required assessment course. After completing a pre-test, participants were randomly assigned to one of four conditions: beliefs-only, approaches-only, combined beliefs and approaches, or control. After completing the online module, students received a lecture on assessment practices and motivation.
RESULTS
The results from our MANCOVA showed that pre-service teachers who participated in the beliefs-only condition reported increased levels of responsibility for student motivation, more growth mindset beliefs, and less fixed mindset beliefs than participants in the other conditions. The approaches-only condition did not influence self-reported mastery or performance approaches to instruction and the combined condition had no effect on beliefs or approaches.
CONCLUSIONS
We discuss the implications for educating pre-service teachers about student motivation and suggest that beliefs and approaches to instruction need to be addressed separately.",2020,"The approaches-only condition did not influence self-reported mastery or performance approaches to instruction and the combined condition had no effect on beliefs or approaches.
",['384 pre-service teachers from one Canadian university participated'],"['beliefs-only, approaches-only, combined beliefs and approaches, or control', 'materials designed for mindsets and/or for approaches to instruction, a consolidation activity, and take-home materials']","['levels of responsibility for student motivation, more growth mindset beliefs, and less fixed mindset beliefs']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]",,0.0570521,"The approaches-only condition did not influence self-reported mastery or performance approaches to instruction and the combined condition had no effect on beliefs or approaches.
","[{'ForeName': 'Lia M', 'Initials': 'LM', 'LastName': 'Daniels', 'Affiliation': 'Department of Educational Psychology, Faculty of Education, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Lauren D', 'Initials': 'LD', 'LastName': 'Goegan', 'Affiliation': 'Department of Educational Psychology, Faculty of Education, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Amanda I', 'Initials': 'AI', 'LastName': 'Radil', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Albertas, Canada.'}, {'ForeName': 'Bryce S', 'Initials': 'BS', 'LastName': 'Dueck', 'Affiliation': 'Department of Educational Psychology, Faculty of Education, University of Alberta, Edmonton, Alberta, Canada.'}]",The British journal of educational psychology,['10.1111/bjep.12393']
2585,33278022,Double-blind placebo-controlled randomized trial of N-acetylcysteine infusion following live donor liver transplantation.,"BACKGROUND
The role of N-acetylcysteine (NAC) in improving outcomes following live donor liver transplantation (LDLT) is not well established. We designed a randomized double-blind placebo-controlled trial to study the role of NAC infusion in recipients undergoing LDLT.
METHODS
We assigned 150 patients who underwent LDLT by computer-generated random sequence on 1:1 ratio to either NAC group or placebo group. Patients in the NAC group received NAC infusion which was started at beginning of graft implantation at an initial loading dose of 150 mg/kg/h over 1 h, followed by 12.5 mg/kg/h for 4 h and then at 6.25 mg/kg/h continued for 91 h. Placebo group received normal saline. The primary endpoint was composite occurrence of acute kidney injury (AKI) and early allograft dysfunction (EAD) in the recipient. Secondary endpoints included levels of bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, INR, primary graft non-function, intraoperative bleeding, post-transplant hospital stay and in-hospital mortality.
RESULTS
The composite endpoint did not show any significant difference between the NAC and placebo group (21.3% vs 29.3%, p = 0.35). Peak AST (425.65 IU/L vs 702.24 IU/L, p = 0.02) and peak ALT (406.65 IU/L vs 677.99 IU/L, p = 0.01) levels were significantly lower in the study group. Time to normalization of transaminases was also significantly low in the study group.
CONCLUSIONS
Perioperative NAC infusion following LDLT resulted in significantly lower postoperative AST and ALT levels. Rapid normalization of transaminases was also observed. This, however, did not translate to improvement in AKI or EAD.",2020,"Peak AST (425.65 IU/L vs 702.24 IU/L, p = 0.02) and peak ALT (406.65 IU/L vs 677.99 IU/L, p = 0.01)","['recipients undergoing LDLT', 'live donor liver transplantation', '150 patients who underwent LDLT by computer-generated random sequence on 1:1 ratio to either NAC group or', 'live donor liver transplantation (LDLT']","['N-acetylcysteine (NAC', 'placebo', 'NAC infusion', 'N-acetylcysteine infusion', 'normal saline', 'Placebo', 'LDLT']","['levels', 'composite occurrence of acute kidney injury (AKI) and early allograft dysfunction (EAD', 'peak ALT', 'postoperative AST and ALT levels', 'levels of bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, INR, primary graft non-function, intraoperative bleeding, post-transplant hospital stay and in-hospital mortality', 'Peak AST', 'Time to normalization of transaminases']","[{'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}]",150.0,0.668604,"Peak AST (425.65 IU/L vs 702.24 IU/L, p = 0.02) and peak ALT (406.65 IU/L vs 677.99 IU/L, p = 0.01)","[{'ForeName': 'Mohammed Abdullatheef', 'Initials': 'MA', 'LastName': 'Thirunavayakalathil', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Christi Titus', 'Initials': 'CT', 'LastName': 'Varghese', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India. christititus@gmail.com.'}, {'ForeName': 'Viju Kumar', 'Initials': 'VK', 'LastName': 'Bharathan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Chandran', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Krishnanunni', 'Initials': 'K', 'LastName': 'Nair', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Johns Shaji', 'Initials': 'JS', 'LastName': 'Mathew', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Binoj Sivasankara Pillai Thankamony', 'Initials': 'BSPT', 'LastName': 'Amma', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Ramachandran Narayana', 'Initials': 'RN', 'LastName': 'Menon', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Unnikrishnan', 'Initials': 'U', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Balakrishnan', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}, {'ForeName': 'Othiyil Vayoth', 'Initials': 'OV', 'LastName': 'Sudheer', 'Affiliation': ''}, {'ForeName': 'Sudhindran', 'Initials': 'S', 'LastName': 'Surendran', 'Affiliation': 'Department of Gastrointestinal Surgery and Solid Organ Transplantation, Amrita Institute of Medical Sciences and Research Centre, Kochi, India.'}]",Hepatology international,['10.1007/s12072-020-10109-y']
2586,33277990,Dapagliflozin does not affect short-term blood pressure variability in patients with type-2 diabetes mellitus.,"BACKGROUND
Increased blood-pressure-variability (BPV) is associated with increased cardiovascular and all-cause mortality in patients with type 2 diabetes mellitus (T2DM). Sodium-glucose-co-transporter-2 (SGLT-2) inhibitors decrease the incidence of cardiovascular events, renal events, and death in this population. This study aimed to evaluate the effect of dapagliflozin on short-term BPV in patients with T2DM.
METHODS
This is a secondary analysis of a double-blind, randomized, placebo-controlled trial in 85 patients with T2DM (NCT02887677). Subjects were randomized to oral dapagliflozin 10mg once daily or placebo for 12 weeks. All participants underwent 24-h ambulatory blood pressure (BP) monitoring with the Mobil-O-Graph NG device at baseline and study-end. Standard-deviation (SD), weighted-SD (wSD), coefficient-of-variation (CV), average-real-variability (ARV) and variation-independent-of-mean (VIM) were calculated with validated formulae for the 24-h and the daytime and nighttime periods.
RESULTS
Dapagliflozin reduced 24-h brachial BP compared to placebo. From baseline to study-end 24-h brachial BPV indexes did not change with dapagliflozin (SBP-ARV: 11.51±3.45 vs 11.05±3.35; p=0.326, SBP-wSD: 13.59±3.60 vs 13.48±3.33; p=0.811) or placebo (SBP-ARV: 11.47±3.63 vs 11.05±3.00; p=0.388, SBP-wSD: 13.85±4.38 vs 13.97±3.87 ; p=0.308). Similarly, no significant changes in BPV indexes for daytime and nighttime were observed in any group. At study-end, no differences between the groups were observed for any BPV index. Deltas(Δ) of all indexes during follow-up were minimal and not different between-groups (SBP-wSD: dapagliflozin: -0.11±3.05 vs placebo: 0.12±4.20; p=0.227).
CONCLUSIONS
This study is the first to evaluate the effects of an SGLT-2 inhibitor on short-term BPV in patients with T2DM, showing no effect on dapagliflozin on all BPV indexes studied.",2020,"At study-end, no differences between the groups were observed for any BPV index.","['patients with T2DM', '85 patients with T2DM (NCT02887677', 'patients with type-2 diabetes mellitus', 'patients with type 2 diabetes mellitus (T2DM']","['Dapagliflozin', 'dapagliflozin', 'oral dapagliflozin 10mg once daily or placebo', 'Sodium-glucose-co-transporter-2 (SGLT-2) inhibitors', 'placebo', 'SGLT-2 inhibitor', '24-h ambulatory blood pressure (BP) monitoring with the Mobil-O-Graph NG device']","['24-h brachial BP', 'BPV indexes for daytime and nighttime', 'incidence of cardiovascular events, renal events, and death', 'Standard-deviation (SD), weighted-SD (wSD), coefficient-of-variation (CV), average-real-variability (ARV) and variation-independent-of-mean (VIM', 'BPV index', '24-h brachial BPV indexes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",85.0,0.229406,"At study-end, no differences between the groups were observed for any BPV index.","[{'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Papadopoulou', 'Affiliation': 'Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Marieta P', 'Initials': 'MP', 'LastName': 'Theodorakopoulou', 'Affiliation': 'Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Glykeria', 'Initials': 'G', 'LastName': 'Tzatzagou', 'Affiliation': 'First Department of Internal Medicine, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Kotsa', 'Affiliation': 'First Department of Internal Medicine, AHEPA Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Zografou', 'Affiliation': 'Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Apostolos', 'Initials': 'A', 'LastName': 'Tsapas', 'Affiliation': 'Second Department of Internal Medicine, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Asterios', 'Initials': 'A', 'LastName': 'Karagiannis', 'Affiliation': 'Second Propaedeutic Department of Internal Medicine, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Aristotle University of Thessaloniki, Hippokration Hospital, Thessaloniki, Greece.'}]",American journal of hypertension,['10.1093/ajh/hpaa207']
2587,33277982,Is treatment in patients suspected of non-radiographic Axial Spondyloarthritis effective? Six months results of a placebo-controlled trial.,"OBJECTIVES
To investigate the efficacy of 16 weeks treatment with etanercept (ETN), in patients suspected of non-radiographic-axial spondyloarthritis (nr-axSpA).
METHODS
TNF inhibitor (TNFi) naive patients with inflammatory back pain (IBP) with at least two SpA-features and high disease activity (Bath Ankylosing Spondylitis Disease Activity Index≥ 4) and without the requirement of positive MRI and/or elevated C-Reactive Protein (CRP), were randomized (1:1) to ETN (n=40) or placebo (PBO) (n=40) for 16 weeks and followed thereafter without study medication up to 24 weeks. Primary endpoint was the Assessment of SpondyloArthritis international Society 20 (ASAS20) response at 16 weeks. Secondary endpoints included ankylosing spondylitis disease activity score (ASDAS), change in mean disease parameters (e.g. Bath Ankylosing Spondylitis metrology index (BASMI), CRP, erythrocyte sedimentation rate (ESR) and Spondyloarthritis Research Consortium of Canada (SPARCC) index scores of the MRI-SIJ, after 16 and 24 weeks.
RESULTS
Patient characteristics at baseline were comparable between ETN and PBO. At 16 weeks, no significant difference was observed in ASAS20 response between ETN (n=6, 16.7%) and PBO (n=4, 11.1%) (RR: 0.7, 95% CI [0.2;2.2], p=0.5). Only ESR-level (-2.2 vs.-1.4) showed more improvement (non-significant) in the ETN group compared to PBO at 16 weeks. Between 16 and 24 weeks, without study medication, the BASMI, CRP- (significant) and ESR-level showed a worsening of scores in ETN group compared to PBO.
CONCLUSION
This study shows that in patients suspected of nr-axSpA with high disease activity but without the requirement of positive MRI and/or elevated CRP treatment with etanercept is not effective.",2020,Only ESR-level (-2.2 vs.-1.4) showed more improvement (non-significant) in the ETN group compared to PBO at 16 weeks.,"['patients suspected of non-radiographic-axial spondyloarthritis (nr-axSpA', 'naive patients with inflammatory back pain (IBP) with at least two SpA-features and high disease activity (Bath Ankylosing Spondylitis Disease Activity Index≥ 4) and without the requirement of positive MRI and/or elevated C-Reactive Protein (CRP']","['etanercept (ETN', 'placebo', 'placebo (PBO', 'ETN', 'TNF inhibitor (TNFi', 'etanercept']","['ankylosing spondylitis disease activity score (ASDAS), change in mean disease parameters (e.g. Bath Ankylosing Spondylitis metrology index (BASMI), CRP, erythrocyte sedimentation rate (ESR) and Spondyloarthritis Research Consortium of Canada (SPARCC) index scores of the MRI-SIJ', 'BASMI, CRP- (significant) and ESR-level', 'ASAS20 response', 'Assessment of SpondyloArthritis international Society 20 (ASAS20) response', 'PBO', 'Only ESR-level']","[{'cui': 'C0522483', 'cui_str': 'Patient suspected of'}, {'cui': 'C3889038', 'cui_str': 'Non-radiographic axial spondyloarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]",,0.158642,Only ESR-level (-2.2 vs.-1.4) showed more improvement (non-significant) in the ETN group compared to PBO at 16 weeks.,"[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rusman', 'Affiliation': 'Amsterdam UMC location VUmc, Department of Rheumatology, Amsterdam, Netherlands.'}, {'ForeName': 'Mignon A C', 'Initials': 'MAC', 'LastName': 'van der Weijden', 'Affiliation': 'Amsterdam UMC location VUmc, Department of Rheumatology, Amsterdam, Netherlands.'}, {'ForeName': 'Micheal T', 'Initials': 'MT', 'LastName': 'Nurmohamed', 'Affiliation': 'Amsterdam UMC location VUmc, Department of Rheumatology, Amsterdam, Netherlands.'}, {'ForeName': 'Robert B M', 'Initials': 'RBM', 'LastName': 'Landewé', 'Affiliation': 'Amsterdam UMC location AMC, Department of Rheumatology, Amsterdam, Netherlands.'}, {'ForeName': 'Janneke J H', 'Initials': 'JJH', 'LastName': 'de Winter', 'Affiliation': 'Amsterdam UMC location AMC, Department of Rheumatology, Amsterdam, Netherlands.'}, {'ForeName': 'Bouke J H', 'Initials': 'BJH', 'LastName': 'Boden', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis (OLVG) Radiology, Amsterdam, Netherlands.'}, {'ForeName': 'Pierre M', 'Initials': 'PM', 'LastName': 'Bet', 'Affiliation': 'Amsterdam UMC VUmc, Department of Clinical Pharmacology, Amsterdam, Netherlands.'}, {'ForeName': 'Carmella M A', 'Initials': 'CMA', 'LastName': 'van der Bijl', 'Affiliation': 'Amsterdam UMC location VUmc, Department of Rheumatology, Amsterdam, Netherlands.'}, {'ForeName': 'Conny', 'Initials': 'C', 'LastName': 'van der Laken', 'Affiliation': 'Amsterdam UMC location VUmc, Department of Rheumatology, Amsterdam, Netherlands.'}, {'ForeName': 'Irene E', 'Initials': 'IE', 'LastName': 'van der Horst-Bruinsma', 'Affiliation': 'Amsterdam UMC location VUmc, Department of Rheumatology, Amsterdam, Netherlands.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41607']
2588,33277980,Pharmacokinetics and Safety of Fosaprepitant Dimeglumine in Healthy Chinese Volunteers: Bioequivalence Study.,"Fosaprepitant dimeglumine (FD) is a precursor of aprepitant. FD can be metabolized into aprepitant. This randomized, single-center, open, 2-cycle, single-dose, crossover bioequivalence study compared the pharmacokinetics (PK) and safety of intravenously FD of test and reference products in healthy volunteers (HVs). HVs were assigned to the test group or reference group randomly and given FD intravenously. The plasma concentration of FD and aprepitant was measured using liquid chromatography-tandem mass spectrometry. PK parameters were ascertained based on a noncompartmental model. Data for 29 HVs were obtained. The geometric mean and 90% confidence intervals of maximum plasma concentration (C max ), area under the concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-t ), and area from the last datum point to time infinity (AUC 0-∞ ) of test and reference groups were 101.69% (95.06%, 108.77%), 103.52% (99.15%, 108.09%), and 105.58% (99.51%, 112.01%), respectively. These 3 parameters were within the acceptance range of 80.0% to 125.00%, and the test product was bioequivalent to the reference product. The coefficient of variation (CV) of C max , AUC 0-t , and AUC 0-∞ was 15.14%, 9.67%, and 11.89%, respectively. Intravenously administered FD provided by 2 sponsors achieved bioequivalence. FD values from test and reference products were bioequivalent. All adverse events were mild and serious adverse events absent in HVs. This study indicated that FD may provide a safer alternative to aprepitant for chemotherapy-induced nausea and vomiting.",2020,"The geometric mean and 90% confidence intervals of maximum plasma concentration (C max ), area under the concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-t ), and area from the last datum point to time infinity (AUC 0-∞ ) of test and reference groups were 101.69% (95.06%, 108.77%), 103.52% (99.15%, 108.09%), and 105.58% (99.51%, 112.01%), respectively.","['healthy volunteers (HVs', 'Healthy Chinese Volunteers']","['Fosaprepitant Dimeglumine', 'Fosaprepitant dimeglumine (FD']","['nausea and vomiting', 'FD values', 'plasma concentration of FD and aprepitant', 'coefficient of variation (CV) of C max , AUC 0-t , and AUC 0-∞', 'Pharmacokinetics and Safety', 'geometric mean and 90% confidence intervals of maximum plasma concentration (C max ), area under the concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-t ), and area from the last datum point to time infinity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C2315887', 'cui_str': 'Fosaprepitant dimeglumine'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C2315887', 'cui_str': 'Fosaprepitant dimeglumine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0702422,"The geometric mean and 90% confidence intervals of maximum plasma concentration (C max ), area under the concentration-time curve from time 0 to time of last measurable plasma concentration (AUC 0-t ), and area from the last datum point to time infinity (AUC 0-∞ ) of test and reference groups were 101.69% (95.06%, 108.77%), 103.52% (99.15%, 108.09%), and 105.58% (99.51%, 112.01%), respectively.","[{'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Bengbu Medical College, Bengbu, China.'}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Hao', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Fang', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Shengjia', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Yongkai', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Ye', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Qigang', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Phase I Clinical Research Center, Zhejiang Provincial People's Hospital, People's Hospital of Hangzhou Medical College, Hangzhou, China.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.892']
2589,33277978,Racial Disparities in Systemic Sclerosis: Short- and Long-Term Outcomes Among African American Participants of SLS I and II.,"OBJECTIVE
To evaluate short- and long-term outcomes of African American (AA) participants of Scleroderma Lung Studies (SLS) I and II.
METHODS
SLS I randomized 158 participants with systemic sclerosis-interstitial lung disease (SSc-ILD) to 1 year of oral cyclophosphamide (CYC) versus placebo. SLS II randomized 142 participants with SSc-ILD to 1 year of oral CYC followed by 1 year of placebo versus 2 years of mycophenolate (MMF). Joint models compared the course of forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO) between AA and non-AA, and Cox proportional hazard models assessed long-term morbidity and mortality outcomes.
RESULTS
In SLS I, there was no difference in the course of the FVC or DLCO between AA and non-AA in either treatment arm. In SLS II, AA had an improved course of the FVC compared with non-AA in the CYC arm; in the MMF arm, there was no difference in FVC course. There was no difference in DLCO course in either arm. Time to death and respiratory failure were similar for AA and non-AA in SLS I. There was a trend for improved survival and time to respiratory failure in AA compared with non-AA in SLS II. AA race was not independently associated with mortality in the SLS I or II in the Cox models.
CONCLUSION
Data from two randomized controlled trials demonstrated that AA patients with SSc-ILD have similar morbidity and mortality outcomes compared with non-AA patients. These findings contrast with the racial disparities described in prior observational studies and warrant further investigation.",2020,There was a trend for improved survival and time to respiratory failure in AA compared with non-AA in SLS II.,"['Systemic Sclerosis', '158 participants with systemic sclerosis-interstitial lung disease (SSc-ILD) to 1 year of', '142 participants with SSc-ILD to 1 year of', 'African American Participants of SLS I and II', 'SLS', 'AA patients with SSc-ILD', 'African American (AA) participants of Scleroderma Lung Studies (SLS) I and II']","['oral CYC', 'mycophenolate (MMF', 'oral cyclophosphamide (CYC) versus placebo', 'placebo']","['DLCO course', 'morbidity and mortality outcomes', 'forced vital capacity (FVC) and diffusing capacity for carbon monoxide (DLCO', 'FVC course', 'survival and time to respiratory failure', 'Time to death and respiratory failure']","[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0037231', 'cui_str': 'Sjögren-Larsson syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",158.0,0.165959,There was a trend for improved survival and time to respiratory failure in AA compared with non-AA in SLS II.,"[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Volkmann', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Steen', 'Affiliation': 'Georgetown University, Washington, DC, United States.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Roth', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Clements', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Furst', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Shervin', 'Initials': 'S', 'LastName': 'Assassi', 'Affiliation': 'University of Texas McGovern Medical School, Houston.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'University of Michigan Medical School, Ann Arbor.'}, {'ForeName': 'Grace-Hyun J', 'Initials': 'GJ', 'LastName': 'Kim', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Elashoff', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'University of California, Los Angeles.'}]",ACR open rheumatology,['10.1002/acr2.11206']
2590,33277909,Global DNA Methylation in Cord Blood and Neurodevelopmental Outcome at 18 Months of Age among Intrauterine Growth Restricted and Appropriate for Gestational Age Infants.,"BACKGROUND
Intrauterine growth restriction (IUGR) is associated with faltered growth and development later in life. Alteration in DNA methylation may occur among IUGR babies and it can have bearing on the outcome.
OBJECTIVES
To compare the DNA methylation in the cord blood among IUGR and appropriate for gestational age (AGA) babies and find it is association with their neurodevelopmental outcome at 18 months of age.
METHODOLOGY
Genomic DNA methylation among 40 IUGR and equal number of AGA neonates was estimated by using 5-mC ELISA kit in the cord blood. Infants were assessed at birth and their anthropometric measurements were taken. They were regularly followed up and assessed for neurodevelopment outcome till 18 months of age using DASII (Developmental Assessment Scale for Indian Infants). DNA methylation was correlated with neurodevelopmental outcome. Numbers and percentages were used for categorical data. Mean and SD were used for continuous variables. The significant mean difference between IUGR and AGA was determined by independent Student t-test. To study the association between the DNA methylation and outcome, Spearman correlation was used. A p < 0.05 was considered as statistically significant.
RESULTS
Significant difference in DNA methylation was observed between IUGR and AGA infants (IUGR: 3.12 ± 1.24; AGA: 4.40 ± 2.03; p < 0.001). Anthropometry (weight, length and head circumference) at birth was significantly decreased among IUGR infants. Hospital stay was significantly longer for IUGR infants. Motor (IUGR: 89.98 ± 18.77; AGA: 101.75 ± 9.62; p < 0.001), and mental (IUGR: 90.81 ± 11.13; AGA: 105.71 ± 7.20; p < 0.001) scores were significantly decreased among IUGR compared with AGA neonates at 18 months of follow-up. Global DNA methylation had a significant positive correlation with mental score but not with motor developmental score.
CONCLUSION
IUGR babies had lower motor and mental score compared with AGA babies. Cord blood global DNA methylation significantly correlated with mental development score but not with motor development at 18 months of age.",2020,"Anthropometry (weight, length and head circumference) at birth was significantly decreased among IUGR infants.",['Gestational Age Infants'],['Intrauterine growth restriction (IUGR'],"['Mean and SD', 'Global DNA Methylation in Cord Blood and Neurodevelopmental Outcome', 'IUGR and AGA', 'Cord blood global DNA methylation', 'DNA methylation', 'lower motor and mental score', 'Hospital stay', 'Anthropometry (weight, length and head circumference) at birth']","[{'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}]",40.0,0.052691,"Anthropometry (weight, length and head circumference) at birth was significantly decreased among IUGR infants.","[{'ForeName': 'Krishna Rao', 'Initials': 'KR', 'LastName': 'Gurugubelli', 'Affiliation': 'Department of Biochemistry, AIIMS, Mangalagiri, Andhra Pradesh 522503, India.'}, {'ForeName': 'Vishnu Bhat', 'Initials': 'VB', 'LastName': 'Ballambattu', 'Affiliation': 'Neonatology, JIPMER, Puducherry 605006, India.'}, {'ForeName': 'Zacheriah', 'Initials': 'Z', 'LastName': 'Bobby', 'Affiliation': 'Biochemistry, JIPMER, Puducherry 605006, India.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmaa108']
2591,33277862,Efficacy of brachytherapy combined with endocrine therapy and external beam radiotherapy in the treatment of intermediate and high-risk localized prostate cancer.,"PURPOSE
To explore the efficacy and safety of brachytherapy combined with endocrine therapy (ET) and external beam radiotherapy (EBRT) in the treatment of patients with intermediate- and high-risk localized prostate cancer (PCa).
METHODS
A total of 128 patients with intermediate- and high-risk localized PCa treated in our hospital, were included, encompassing 64 cases undergoing brachytherapy combined with ET (control group), and 64 cases undergoing intensity-modulated EBRT on the above basis (combination group). The clinical efficacy, adverse reactions, the serum prostate specific antigen (PSA) level before and after treatment, maximum urinary flow rate (Qmax), and expanded prostate cancer index composite (EPIC) score were compared between the two groups. The overall survival (OS) of patients was analyzed using the Kaplan-Meier method and log-rank test.
RESULTS
After treatment, the EPIC scores of urinary function, intestinal function, sexual function and hormone function declined significantly in both groups, and they were significantly higher in the combination group than in the control group. At 12 months after treatment, the combination group had an obviously lower serum PSA level, and obviously higher Qmax than the control group. All patients were followed up for 12-60 months. In the combination and control group, OS was 87.5% and 81.3%, disease-specific survival (DSS) was 89.1% and 78.1%, the biochemical progression-free survival (bPFS) was 76.6% and 60.9%, and distant metastasis free survival (DMFS) was 87.5% and 71.9%, respectively. Log-rank test showed no statistically significant differences in OS and DSS between the two groups, but both bPFS and DMFS in the combination group were remarkably superior compared with the control group.
CONCLUSIONS
Brachytherapy combined with ET and EBRT has definite efficacy in intermediate- and high-risk localized PCa, which can significantly improve the physiological function, raise the quality of life of patients, and effectively control the disease progression.",2020,"After treatment, the EPIC scores of urinary function, intestinal function, sexual function and hormone function declined significantly in both groups, and they were significantly higher in the combination group than in the control group.","['intermediate and high-risk localized prostate cancer', 'patients with intermediate- and high-risk localized prostate cancer (PCa', '128 patients with intermediate- and high-risk localized PCa treated in our hospital, were included, encompassing 64 cases undergoing brachytherapy combined with ET (control group), and 64 cases undergoing intensity-modulated EBRT on the above basis (combination group']","['brachytherapy combined with endocrine therapy (ET) and external beam radiotherapy (EBRT', 'Brachytherapy combined with ET and EBRT', 'brachytherapy combined with endocrine therapy and external beam radiotherapy']","['maximum urinary flow rate (Qmax), and expanded prostate cancer index composite (EPIC) score', 'OS and DSS', 'overall survival (OS', 'disease-specific survival (DSS', 'bPFS and DMFS', 'distant metastasis free survival (DMFS', 'serum PSA level', 'biochemical progression-free survival (bPFS', 'efficacy and safety', 'EPIC scores of urinary function, intestinal function, sexual function and hormone function', 'clinical efficacy, adverse reactions, the serum prostate specific antigen (PSA) level']","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0006098', 'cui_str': 'Brachytherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429783', 'cui_str': 'Urinary flow rate'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",128.0,0.0205876,"After treatment, the EPIC scores of urinary function, intestinal function, sexual function and hormone function declined significantly in both groups, and they were significantly higher in the combination group than in the control group.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urologic Surgery, Jinchang Central Hospital of Gansu Province, 53 Beijing Rd, Jinchang, Gansu 737100, China.'}, {'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Mengxian', 'Initials': 'M', 'LastName': 'Qin', 'Affiliation': ''}, {'ForeName': 'Xuehai', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jiarui', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Shengwu', 'Initials': 'S', 'LastName': 'Chai', 'Affiliation': ''}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
2592,33277859,Research on the efficacy of laryngendoscopic low-temperature plasma ablation on early glottic cancer.,"PURPOSE
To evaluate the efficacy and safety of self-retaining laryngendoscope-assisted low-temperature plasma ablation (LTPA) in the treatment of patients with early glottic cancer.
METHODS
The clinical data of 84 patients with early glottic cancer treated in our department from May 2013 to May 2016 were collected. All patients were divided into the Plasma group (n=42, treated with the laryngendoscopic LTPA) and the Laryngofissure group (n=42, treated with traditional laryngofissure). The operation conditions, pain and cough visual analogue scale (VAS) scores, postoperative complications, mucosal recovery and voice recovery indexes were compared between the two groups, the postoperative recurrence rate was recorded, and the patients were followed up for tumor recurrence and survival.
RESULTS
In the Plasma group, the operation time was significantly shorter than that in the Laryngofissure group, the amount of intraoperative bleeding was significantly less than that in the Laryngofissure group (p<0.001), and the postoperative hospitalization time was also significantly shorter than that in the Laryngofissure group. The postoperative pain and cough VAS scores in the Plasma group were obviously lower than those in the Laryngofissure group. The proportion of smooth vocal mucosa after operation in the Plasma group was evidently higher than that in the Laryngofissure group. In Plasma group, the voice parameters Jitter, Shimmer and harmonic to noise ratio (HNR) were all remarkably superior to those in the Laryngofissure group. The overall survival (OS) and progression-free survival (PFS) had no statistically significant differences between the two groups according to the log-rank test.
CONCLUSIONS
Self-retaining laryngendoscope-assisted LTPA has definite efficacy in the treatment of early glottic cancer, after which the recurrence rate and survival rate are similar to those after open laryngofissure, but LTPA is characterized by short operation time, less postoperative bleeding, quick recovery of patients and better voice recovery.",2020,"The overall survival (OS) and progression-free survival (PFS) had no statistically significant differences between the two groups according to the log-rank test.
","['patients with early glottic cancer', '84 patients with early glottic cancer treated in our department from May 2013 to May 2016 were collected', 'early glottic cancer']","['Laryngofissure group (n=42, treated with traditional laryngofissure', 'self-retaining laryngendoscope-assisted low-temperature plasma ablation (LTPA', 'laryngendoscopic LTPA', 'laryngendoscopic low-temperature plasma ablation']","['operation conditions, pain and cough visual analogue scale (VAS) scores, postoperative complications, mucosal recovery and voice recovery indexes', 'overall survival (OS) and progression-free survival (PFS', 'operation time', 'proportion of smooth vocal mucosa', 'postoperative pain and cough VAS scores', 'recurrence rate and survival rate', 'amount of intraoperative bleeding', 'postoperative hospitalization time', 'postoperative recurrence rate', 'voice parameters Jitter, Shimmer and harmonic to noise ratio (HNR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0392126', 'cui_str': 'Laryngofissure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",84.0,0.0152267,"The overall survival (OS) and progression-free survival (PFS) had no statistically significant differences between the two groups according to the log-rank test.
","[{'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Jing', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, General Hospital of Xinjiang Military Command, Urumqi 830000, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': ''}, {'ForeName': 'Yongxiang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Songzi', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Longfang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
2593,33277845,Effect of postoperative sequential chemoradiotherapy and concurrent chemoradiotherapy in treating advanced endometrial cancer.,"PURPOSE
To evaluate the efficacy and safety of the sequential chemoradiotherapy mode of chemotherapy-radiotherapy-consolidation chemotherapy and the concurrent chemoradiotherapy after operation for advanced (stage III-IV) endometrial cancer.
METHODS
A total of 116 patients with stage III-IV endometrial cancer were divided into the Sequential group (n=58) and the Concurrent group (n=58) according to the different modes of postoperative adjunctive therapy. The levels of tumor markers in the serum and the occurrence of adverse reactions were compared between the two groups, and the survival and progression of the patients were followed up and recorded. Moreover, the factors influencing the tumor progression in patients were analyzed.
RESULTS
The levels of serum carcino-embryonic antigen (CEA), cancer antigen (CA) 125, CA19-9 and adiponectin (APN) declined markedly after treatment with chemoradiotherapy in both groups compared with those before treatment (p<0.05). The median survival was 49.4±4.5 months and 47.9±4.0 months, and the median progression-free survival (PFS) was 47.1±4.6 months and 45.8±4.3 months, respectively, in the Sequential group and the Concurrent group. Besides, the 3-year overall survival (OS) rate in the Sequential group and the Concurrent group was 82.8% and 70.7%, respectively, and the 3-year PFS rate in the two groups was 79.3% and 58.6%, respectively. The 5-year OS rate was 60.3% and 48.3%, and the 5-year PFS rate was 51.7% and 32.8% in the two groups, respectively. Log-rank test indicated that the PFS in the Sequential group was evidently superior to that in the Concurrent group (p=0.017). The results of univariate and multivariate analyses manifested that surgical-pathological stage and postoperative Sequential chemoradiotherapy were independent risk factors for tumor progression in patients with advanced endometrial cancer.
CONCLUSIONS
Compared with the concurrent chemoradiotherapy, the sequential chemoradiotherapy can prominently delay the progression of advanced endometrial cancer, induce no apparent adverse reactions and has good tolerance. Low surgical-pathological stage and postoperative sequential chemoradiotherapy are independent protective factors against tumor progression.",2020,"125, CA19-9 and adiponectin (APN) declined markedly after treatment with chemoradiotherapy in both groups compared with those before treatment (p<0.05).","['advanced (stage III-IV) endometrial cancer', 'treating advanced endometrial cancer', '116 patients with stage III-IV endometrial cancer', 'patients with advanced endometrial cancer']","['chemotherapy-radiotherapy-consolidation chemotherapy', 'concurrent chemoradiotherapy', 'chemoradiotherapy', 'postoperative sequential chemoradiotherapy and concurrent chemoradiotherapy']","['CA19-9 and adiponectin (APN', 'levels of serum carcino-embryonic antigen (CEA), cancer antigen (CA', 'levels of tumor markers in the serum and the occurrence of adverse reactions', '3-year PFS rate', 'median survival', '5-year PFS rate', 'median progression-free survival (PFS', 'efficacy and safety', '3-year overall survival (OS) rate', 'survival and progression', '5-year OS rate']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0007103', 'cui_str': 'Endometrial neoplasms malignant'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3179017', 'cui_str': 'Consolidation Chemotherapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0041365', 'cui_str': 'Biomarkers, Cancer'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",116.0,0.0375685,"125, CA19-9 and adiponectin (APN) declined markedly after treatment with chemoradiotherapy in both groups compared with those before treatment (p<0.05).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
2594,33277825,Heart failure in the last year: progress and perspective.,"Research about heart failure (HF) has made major progress in the last years. We give here an update on the most recent findings. Landmark trials have established new treatments for HF with reduced ejection fraction. Sacubitril/valsartan was superior to enalapril in PARADIGM-HF trial, and its initiation during hospitalization for acute HF or early after discharge can now be considered. More recently, new therapeutic pathways have been developed. In the DAPA-HF and EMPEROR-Reduced trials, dapagliflozin and empagliflozin reduced the risk of the primary composite endpoint, compared with placebo [hazard ratio (HR) 0.74; 95% confidence interval (CI) 0.65-0.85; P < 0.001 and HR 0.75; 95% CI 0.65-0.86; P < 0.001, respectively]. Second, vericiguat, an oral soluble guanylate cyclase stimulator, reduced the composite endpoint of cardiovascular death or HF hospitalization vs. placebo (HR 0.90; 95% CI 0.82-0.98; P = 0.02). On the other hand, both the diagnosis and treatment of HF with preserved ejection fraction, as well as management of advanced HF and acute HF, remain challenging. A better phenotyping of patients with HF would be helpful for prognostic stratification and treatment selection. Further aspects, such as the use of devices, treatment of arrhythmias, and percutaneous treatment of valvular heart disease in patients with HF, are also discussed and reviewed in this article.",2020,"Second, vericiguat, an oral soluble guanylate cyclase stimulator, reduced the composite endpoint of cardiovascular death or HF hospitalization vs. placebo (HR 0.90; 95% CI 0.82-0.98; P = 0.02).",['patients with HF'],"['dapagliflozin and empagliflozin', 'Sacubitril/valsartan', 'enalapril']","['composite endpoint of cardiovascular death or HF hospitalization', 'Heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.1514,"Second, vericiguat, an oral soluble guanylate cyclase stimulator, reduced the composite endpoint of cardiovascular death or HF hospitalization vs. placebo (HR 0.90; 95% CI 0.82-0.98; P = 0.02).","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Tomasoni', 'Affiliation': 'Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Adamo', 'Affiliation': 'Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Markus S', 'Initials': 'MS', 'LastName': 'Anker', 'Affiliation': 'Division of Cardiology and Metabolism, Department of Cardiology (CVK), Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'von Haehling', 'Affiliation': 'Department of Cardiology and Pneumology, University of Göttingen Medical Center, Göttingen, Germany.'}, {'ForeName': 'Andrew J S', 'Initials': 'AJS', 'LastName': 'Coats', 'Affiliation': 'Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}]",ESC heart failure,['10.1002/ehf2.13124']
2595,33277698,"Mulberry leaf attenuates atherosclerotic lesions in patients with coronary heart disease possibly via 1-Deoxynojirimycin: A placebo-controlled, double-blind clinical trial.","Mulberry leaf tea reduces atherosclerotic lesions and its main component is Deoxynojirimycin (DNJ). We aimed to explore the effects of Mulberry leaf DNJ (MLD) on atherosclerotic lesions in the patients with coronary heart disease (CHD). MLD and serum DNJ was detected by high-performance liquid chromatography (HPLC). The CHD patients with low-density lipoprotein cholesterol >140 mg/dl were assigned into the EG (MLD treatment) and the CG (placebo treatment) groups. Serum biochemical indices, the cerebrovascular and cardiovascular events and carotid intima-media thickness (IMT) were measured before and after a 1-year intervention. Pearson Correlation Coefficient test was used to explore the relationship between serum levels of DNJ and IMT values. Serum DNJ was 70 ± 50 ng/ml in the EG group but no serum DNJ was detected in the CG group. The incidence of cerebrovascular and cardiovascular events in the EG was lower than that in the CG group (p < .05). MLD therapy improved antioxidant and anti-inflammatory properties and serum lipid profile (p < .05). The IMT values in the EG group were lower than those in the CG group (p < .05). Serum levels of DNJ had a strong negative relationship with IMT values. MLD treatment attenuates atherosclerotic lesions possibly via DNJ. PRACTICAL APPLICATIONS: Mulberry leaves Deoxynojirimycin (MLD) treatment improved antioxidant and anti-inflammatory properties and serum lipid profile in heart disease patients. MLD reduce carotid intima-media thickness (IMT) and serum levels of DNJ (the main ingredient of mulberry leaf) had a strong relationship with IMT values. MLD is an amazing treat used for reducing the incidence of cerebrovascular and cardiovascular events in heart disease patients.",2020,The incidence of cerebrovascular and cardiovascular events in the EG was lower than that in the CG group (p < .05).,"['patients with coronary heart disease possibly via 1-Deoxynojirimycin', 'heart disease patients', '50', 'patients with coronary heart disease (CHD', 'CHD patients with low-density lipoprotein cholesterol\xa0>140\xa0mg/dl']","['MLD', 'Mulberry leaf', 'placebo', 'CG (placebo', 'Mulberry leaves Deoxynojirimycin (MLD', 'Mulberry leaf tea', 'Mulberry leaf DNJ (MLD']","['incidence of cerebrovascular and cardiovascular events', 'MLD reduce carotid intima-media thickness (IMT) and serum levels of DNJ', 'serum levels of DNJ and IMT values', 'serum DNJ', 'Serum levels of DNJ', 'antioxidant and anti-inflammatory properties and serum lipid profile', 'IMT values', 'Serum biochemical indices, the cerebrovascular and cardiovascular events and carotid intima-media thickness (IMT', 'atherosclerotic lesions', 'MLD and serum DNJ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}, {'cui': 'C0089267', 'cui_str': 'Duvoglustat-containing product'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0330540', 'cui_str': 'Morus'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0089267', 'cui_str': 'Duvoglustat-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0330540', 'cui_str': 'Morus'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0089267', 'cui_str': 'Duvoglustat-containing product'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.0634645,The incidence of cerebrovascular and cardiovascular events in the EG was lower than that in the CG group (p < .05).,"[{'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'The Third Operating Room, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Shui', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiovascular, The First Hospital of Jilin University, Changchun, China.'}]",Journal of food biochemistry,['10.1111/jfbc.13573']
2596,33277648,Effects of Acute Tryptophan Depletion on Human Taste Perception.,"Taste perception has been reported to vary with changes in affective state. Distortions of taste perception, including blunted recognition thresholds, intensity and hedonic ratings have been identified in those suffering from depressive disorders. Serotonin is a key neurotransmitter implicated in the aetiology of anxiety and depression; systemic and peripheral manipulations of serotonin signalling have previously been shown to modulate taste detection. However, the specific effects of central serotonin function on taste processing have not been widely investigated. Here, in a double-blind placebo-controlled study, acute tryptophan depletion was used to investigate the effect of reduced central serotonin function on taste perception. 25 female participants aged 18-28 attended the laboratory on 2 occasions at least 1 week apart. On one visit they received a tryptophan depleting drink and on the other a control drink was administered. Approximately 6 hours after drink consumption they completed a taste perception task which measured detection thresholds and supra-threshold perceptions of the intensity and pleasantness of four basic tastes (sweet, sour, bitter and salt). While acutely reducing central levels of serotonin had no effect on the detection thresholds of sweet, bitter or sour tastes it significantly enhanced detection of salt. For supra-threshold stimuli, acutely reduced serotonin levels significantly enhanced the perceived intensity of both bitter and sour tastes and blunted pleasantness ratings of bitter quinine. These findings show manipulation of central serotonin levels can modulate taste perception and are consistent with previous reports that depletion of central serotonin levels enhances neural and behavioural responsiveness to aversive signals.",2020,"While acutely reducing central levels of serotonin had no effect on the detection thresholds of sweet, bitter or sour tastes it significantly enhanced detection of salt.",['25 female participants aged 18-28 attended the laboratory on 2 occasions at least 1 week apart'],"['placebo', 'tryptophan depleting drink', 'Acute Tryptophan Depletion', 'Serotonin']",['Human Taste Perception'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}]",25.0,0.0924135,"While acutely reducing central levels of serotonin had no effect on the detection thresholds of sweet, bitter or sour tastes it significantly enhanced detection of salt.","[{'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'Research Centre for Brain & Behaviour, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Paula D', 'Initials': 'PD', 'LastName': 'Trotter', 'Affiliation': 'Research Centre for Brain & Behaviour, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'McGlone', 'Affiliation': 'Research Centre for Brain & Behaviour, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Susannah C', 'Initials': 'SC', 'LastName': 'Walker', 'Affiliation': 'Research Centre for Brain & Behaviour, Liverpool John Moores University, Liverpool, UK.'}]",Chemical senses,['10.1093/chemse/bjaa078']
2597,33277646,Ultrasound guidance and risk for central venous catheter-related infections in the ICU. A post hoc analysis of individual data of three multi-centric randomized trials.,"BACKGROUND
Ultrasound (US) guidance is frequently used in critically ill patients for central venous catheter (CVC) insertion. The effect of US on infectious risk remains controversial and randomized-controlled trials (RCTs) assessed mainly non-infectious complications. This study assessed infectious risk associated with catheters inserted with US guidance versus use of anatomical 'landmarks' (AL).
METHODS
We used individual data from three large RCTs for which a prospective, high-quality data collection was performed. Adult patients were recruited in various intensive care units (ICU) in France as soon as they required short-term CVC insertion. We applied marginal Cox models with inverse probability weighting to estimate the effect of US-guided insertion on catheter-related bloodstream infections (CRBSI, primary outcome) and major catheter-related infections (MCRI, secondary outcome).We also evaluated insertion site colonization at catheter removal.
RESULTS
Our post hoc analysis included 4636 patients and 5502 catheters inserted in 2088 jugular, 1733 femoral and 1681 subclavian veins, respectively, in 19 ICUs. US was used for 2147 catheter insertions. Among jugular and femoral CVCs and after weighting, we found an association between US and CRBSI (HR 2.21, 95% CI 1.17-4.16, p=0.014) and between US and MCRI (HR 1.55, 95% CI 1.01-2.38, p=0.045). Catheter insertion site colonization at removal was more common in the US-guided group (p=0.0045) among jugular and femoral CVCs in situ for ≤7 days (n=606).
CONCLUSIONS
In prospectively collected data in which catheters were not randomized to insertion by US or AL, US guidance was associated with increased risk of infection.",2020,"Catheter insertion site colonization at removal was more common in the US-guided group (p=0.0045) among jugular and femoral CVCs in situ for ≤7 days (n=606).
","['4636 patients and 5502 catheters inserted in 2088 jugular, 1733 femoral and 1681 subclavian veins, respectively, in 19 ICUs', 'Adult patients were recruited in various intensive care units (ICU) in France as soon as they required short-term CVC insertion', 'critically ill patients for central venous catheter (CVC) insertion']","[""catheters inserted with US guidance versus use of anatomical 'landmarks' (AL"", 'Ultrasound (US) guidance']",['risk of infection'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0038532', 'cui_str': 'Structure of subclavian vein'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0558288', 'cui_str': 'As required'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",4636.0,0.156043,"Catheter insertion site colonization at removal was more common in the US-guided group (p=0.0045) among jugular and femoral CVCs in situ for ≤7 days (n=606).
","[{'ForeName': 'Niccolò', 'Initials': 'N', 'LastName': 'Buetti', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Mimoz', 'Affiliation': 'Services des Urgences Adultes and SAMU 86, Centre Hospitalier Universitaire de Poitiers, Poitiers, France; Université de Poitiers, Poitiers, France; Inserm U1070, Poitiers, France.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Mermel', 'Affiliation': 'Division of Infectious Diseases, Rhode Island Hospital and Department of Medicine, Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Ruckly', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Mongardon', 'Affiliation': ""Service d'Anesthésie-Réanimation Chirurgicale, Hôpitaux Universitaires Henri Mondor, DMU CARE, Assistance Publique - Hôpitaux de Paris (AP-HP), Inserm U955 équipe 3, Faculté de Santé, Université Paris-Est Créteil, Créteil, France.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dupuis', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Groupe Hospitalier Paris Centre - Cochin University Hospital - APHP, Paris Descartes University, Paris, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Lucet', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Mégarbane', 'Affiliation': 'Service de réanimation médicale et toxicologie, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Bailly', 'Affiliation': 'Univ. Grenoble Alpes, INSERM U1042, HP2, 38000 Grenoble, France EFCR laboratory, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Parienti', 'Affiliation': 'Department of Biostatistics and Clinical Research and Department of Infectious Diseases, Caen University Hospital, Caen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Timsit', 'Affiliation': 'University of Paris, INSERM IAME, U1137, Team DesCID, Paris, France.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1817']
2598,33277607,In vivo investigation of diode laser application on red complex bacteria in non-surgical periodontal therapy: a split-mouth randomised control trial.,"Assessment of the efficacy of a single 810 nm diode laser application as an adjunctive treatment modality during the first intervention of non-surgical periodontal therapy (NPT). 25 patients diagnosed with chronic periodontitis underwent a split-mouth randomised control trial. The periodontal pockets of the test quadrants were treated with an 810 nm diode laser as an adjunct to NPT (Picasso GaAlAs; AMD Lasers). The laser was set at 1.0 W continuous wave, 400 µm tip, 796 W/cm 2 peak power density and a 32 J/cm 2 energy density. Therapeutic outcomes were evaluated based on the clinical parameters, which included probing pocket depth, recession, clinical attachment level, full mouth plaque score, full mouth bleeding on probing and tooth mobility. The baseline bacterial collection was completed from the periodontal pockets and then re-evaluated at 6 weeks. Clinical parameters demonstrated no statistical difference, with the exception of a statistically significant (P < 0.05) reduction in bleeding on probing for the test side. The test side resulted in a statistical increase of Capnocytophaga species and Treponema denticola. The single application of the diode laser did not significantly improve the bacterial nor the clinical parameters in patients with chronic periodontitis.Trial registration number: PACTR201909915338276.",2020,"Clinical parameters demonstrated no statistical difference, with the exception of a statistically significant (P < 0.05) reduction in bleeding on probing for the test side.","['non-surgical periodontal therapy (NPT', 'patients with chronic periodontitis', '25 patients diagnosed with chronic periodontitis', 'non-surgical periodontal therapy']","['810\xa0nm diode laser as an adjunct to NPT (Picasso GaAlAs; AMD Lasers', 'diode laser', 'single 810\xa0nm diode laser application', 'diode laser application']","['Capnocytophaga species and Treponema denticola', 'probing pocket depth, recession, clinical attachment level, full mouth plaque score, full mouth bleeding on probing and tooth mobility', 'red complex bacteria']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0006916', 'cui_str': 'Capnocytophaga'}, {'cui': 'C0318222', 'cui_str': 'Treponema denticola'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040445', 'cui_str': 'Tooth mobility'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",25.0,0.0376786,"Clinical parameters demonstrated no statistical difference, with the exception of a statistically significant (P < 0.05) reduction in bleeding on probing for the test side.","[{'ForeName': 'Suné', 'Initials': 'S', 'LastName': 'Mulder-van Staden', 'Affiliation': 'Faculty of Dentistry, Oral Medicine and Periodontics, University of the Western Cape, Fransie van Zijl drive, Cape Town, 7505, South Africa. smuldervanstaden@uwc.ac.za.'}, {'ForeName': 'Haly', 'Initials': 'H', 'LastName': 'Holmes', 'Affiliation': 'Faculty of Dentistry, Oral Medicine and Periodontics, University of the Western Cape, Fransie van Zijl drive, Cape Town, 7505, South Africa.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Hille', 'Affiliation': 'Department of Oral and Maxillofacial Pathology, Faculty of Dentistry, Oral and Maxillofacial Pathology, University of the Western Cape, Cape Town, South Africa.'}]",Scientific reports,['10.1038/s41598-020-78435-7']
2599,33277579,Increasing prosocial behavior and decreasing selfishness in the lab and everyday life.,"The tension between selfishness and prosocial behavior is crucial to understanding many social interactions and conflicts. Currently little is known how to promote prosocial behaviors, especially in naturally occurring relationships outside the laboratory. We examined whether a psychological micro-intervention would promote prosocial behaviors in couples. Across two studies, we randomized dyads of couples to a micro-intervention (15 min), which increased prosocial behaviors by 28% and decreased selfish behaviors by 35% a week later in behavioral games in a dose-response manner. Using event sampling methodology, we further observed an increase in prosocial behaviors across one week that was most pronounced in participants who received the intervention. These results from the laboratory and everyday life are important for researchers interested in prosocial behavior and selfishness and have practical relevance for group interactions.",2020,"Using event sampling methodology, we further observed an increase in prosocial behaviors across one week that was most pronounced in participants who received the intervention.",['couples'],['psychological micro-intervention'],"['selfish behaviors', 'prosocial behaviors']","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0296138,"Using event sampling methodology, we further observed an increase in prosocial behaviors across one week that was most pronounced in participants who received the intervention.","[{'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Gloster', 'Affiliation': 'Division of Clinical Psychology and Intervention Science, Faculty of Psychology, University of Basel, Missionsstrasse 62 A, 4055, Basel, Switzerland. andrew.gloster@unibas.ch.'}, {'ForeName': 'Marcia T B', 'Initials': 'MTB', 'LastName': 'Rinner', 'Affiliation': 'Division of Clinical Psychology and Intervention Science, Faculty of Psychology, University of Basel, Missionsstrasse 62 A, 4055, Basel, Switzerland.'}, {'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Meyer', 'Affiliation': 'Division of Clinical Psychology & Epidemiology, Faculty of Psychology, University of Basel, Basel, Switzerland.'}]",Scientific reports,['10.1038/s41598-020-78251-z']
2600,33277507,Long-term safety of tiotropium/olodaterol in older patients with moderate-to-very-severe COPD in the TONADO® studies.,"Older patients with chronic obstructive pulmonary disease (COPD) may be at increased risk of adverse events (AEs) due to decreased protective organ function and increased comorbidities. TONADO® 1 + 2 were replicate, randomized, double-blind, parallel-group, 52-week, Phase III trials comparing the efficacy and safety of tiotropium/olodaterol (5/5 µg) versus the monocomponents via the Respimat® inhaler in patients with moderate-to-very-severe COPD. In this prespecified safety analysis, patients were grouped by age. Of 3100 patients, 1585 (51.1%) were aged <65 years, 1198 (38.7%) 65-<75 years, 309 (10.0%) 75-<85 years, and eight (0.3%) ≥85 years. At baseline, 23.4% had a pre-existing cardiac disorder, 45.6% had hypertension, and 13.3% had glucose metabolism disorders, including diagnosed diabetes. Overall, there was no increase in major adverse cardiac events, other AEs, or serious AEs with tiotropium/olodaterol versus the monocomponents in any age group, supporting the safety of tiotropium/olodaterol in older patients with COPD.",2020,"Overall, there was no increase in major adverse cardiac events, other AEs, or serious AEs with tiotropium/olodaterol versus the monocomponents in any age group, supporting the safety of tiotropium/olodaterol in older patients with COPD.","['Of 3100 patients, 1585 (51.1%) were aged <65 years, 1198 (38.7%) 65-<75 years, 309 (10.0%) 75-<85 years, and eight (0.3%) ≥85 years', 'older patients with COPD', 'patients with moderate-to-very-severe COPD', 'older patients with moderate-to-very-severe COPD', 'Older patients with chronic obstructive pulmonary disease (COPD']","['tiotropium/olodaterol', 'tiotropium/olodaterol (5/5\u2009µg) versus the monocomponents via the Respimat® inhaler', 'tiotropium']","['efficacy and safety', 'major adverse cardiac events, other AEs, or serious AEs', 'glucose metabolism disorders']","[{'cui': 'C4517705', 'cui_str': '3100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1257958', 'cui_str': 'Disorder of glucose metabolism'}]",3100.0,0.243467,"Overall, there was no increase in major adverse cardiac events, other AEs, or serious AEs with tiotropium/olodaterol versus the monocomponents in any age group, supporting the safety of tiotropium/olodaterol in older patients with COPD.","[{'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, 29255 West 10 Mile Road, Suite A, Farmington Hills, MI, 48336, USA. garytferguson@msn.com.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Maltais', 'Affiliation': 'Centre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laal, 2725 Chemin Sainte-Foy, Québec City, QC, G1V 4G5, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Karpel', 'Affiliation': 'North Shore Medical Arts LLP, 295 Community Drive, Great Neck, New York, NY, 11021, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Bothner', 'Affiliation': 'Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Kloer', 'Affiliation': 'Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Trampisch', 'Affiliation': 'Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Pulmonary Department, Johannes Gutenberg University Mainz, Langenbeckstrasse 1, D-55131, Mainz, Germany.'}]",NPJ primary care respiratory medicine,['10.1038/s41533-020-00212-w']
2601,33277455,Can L-Carnitine Supplementation Improve Cardiopulmonary Function? A Randomized Controlled Clinical Trial in Hemodialysis Patients.,"INTRODUCTION
L-Carnitine is a cardioprotective agent which balances metabolism by promoting mitochondrial β-oxidation and facilitating transportation of long chain fatty acids into the mitochondrial matrix. It has been shown that L-Carnitine level in plasma and tissue is lower in hemodialysis patients and they may lose the benefits of this substance. The aim of this trial was to evaluate the effects of L-Carnitine supplementation on cardiorespiratory Function in hemodialysis patients through ergospirometry.
METHODS
The current study was conducted on 46 chronic hemodialysis patients. The patients were divided into two groups. In both groups ergospirometry parameters (VE Max, VO2-Max and VCO2 Max, AT, VE/VCO2 Slope) were recorded for a 3-month period of time. During this period, one group received L-Carnitine at doses of 2 g/d orally and the other group received only placebo. After three months, all of the mentioned parameters reevaluated and statistical analysis was done.
RESULTS
Only CRP value was different between two group and in placebo group increased significantly after 3 months (P < .05). No significant difference was detected in Cardio-respiratory factors. In terms of ergospirometry, PET-CO2 was the only parameter which was significantly increased in the treatment group but decreased in placebo group (P < .05).
CONCLUSION
Significant differences between our groups showed that L-Carnitine could help hemodialysis patients with cardiopulmonary problems to suffer lower rate of inflammation and poor life quality as shown at least in comparison of the two factors including CRP and PETCO2 at rest.",2020,Only CRP value was different between two group and in placebo group increased significantly after 3 months (P < .05).,"['46 chronic hemodialysis patients', 'hemodialysis patients', 'Hemodialysis Patients', 'hemodialysis patients through ergospirometry']","['L-Carnitine', 'L-Carnitine supplementation', 'L-Carnitine Supplementation', 'placebo']","['CRP value', 'rate of inflammation and poor life quality', 'cardiorespiratory Function', 'Cardio-respiratory factors', 'ergospirometry parameters (VE Max, VO2-Max and VCO2 Max, AT, VE/VCO2 Slope']","[{'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C3805144', 'cui_str': 'Ergospirometry'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3805144', 'cui_str': 'Ergospirometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}]",46.0,0.0494613,Only CRP value was different between two group and in placebo group increased significantly after 3 months (P < .05).,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yassari', 'Affiliation': ''}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': ''}, {'ForeName': 'Sayed Mehran', 'Initials': 'SM', 'LastName': 'Marashian', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Eslaminejad', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti Medical University, Tehran, Iran. eslaminejadalireza@yahoo.com.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Maleki Kazeri', 'Affiliation': ''}]",Iranian journal of kidney diseases,[]
2602,33274542,"Tumor response and symptom palliation from RAINBOW, a phase 3 trial of ramucirumab plus paclitaxel in previously treated advanced gastric cancer.","BACKGROUND
In the intent-to-treat (ITT) population of the RAINBOW study, objective response rate (ORR) was 28% and 16% in the ramucirumab and control arms, respectively. To further characterize tumor response, we present details on timing and extent of tumor shrinkage, as well as associations with symptom palliation. Clinicaltrials.gov NCT01170663 MATERIALS AND METHODS: Tumor response was assessed with RECIST v1.1, and quality of life (QoL) was assessed with the EORTC QLQ-C30 v3.0. Pre-specified and post hoc analyses were conducted in the ITT population, patients with measurable disease, or responders, and included best overall response (BOR), ORR, disease control rate (DCR), duration of response, time to response (TtR), change in tumor size, and associations of QoL with tumor shrinkage and BOR.
RESULTS
In both treatment arms, median TtR was 1.5 months. Responses were more durable in the ramucirumab versus control arm (median 4.4 vs 2.8 months). In patients with measurable disease (78% of ITT), ORR was 36% versus 20%; DCR was 81% versus 61% in the ramucirumab versus control arms. Waterfall plots demonstrated more tumor shrinkage in the ramucirumab versus control arm. Regardless of treatment, tumor response and stable disease were associated with improved/stable QoL, with more tumor shrinkage associated with greater symptom palliation.
CONCLUSIONS
Treatment with ramucirumab plus paclitaxel yielded the highest ORR reported to date for patients with previously treated advanced gastric/gastroesophageal junction adenocarcinoma. Additional details demonstrate robustness of tumor response results. The extent of tumor shrinkage is directly associated with symptom palliation and should be considered when evaluating patient needs and treatment selection.
IMPLICATIONS FOR PRACTICE
Ramucirumab plus paclitaxel is a recognized standard of care as it improves survival for patients with advanced gastric or gastroesophageal junction adenocarcinoma who have been previously treated with recommended first-line therapy. These additional data on tumor response demonstrate a positive association between tumor shrinkage and symptom palliation in a patient population that is often symptomatic. These observations included patients with non-measurable disease, a group of patients often underrepresented in clinical trials. This knowledge can inform treatment decisions, which align individual patient characteristics and needs with demonstrated benefits.",2020,Responses were more durable in the ramucirumab versus control arm (median 4.4 vs 2.8 months).,"['patients with advanced gastric or gastroesophageal junction adenocarcinoma who have been previously treated with recommended first-line therapy', 'previously treated advanced gastric cancer', 'patients with previously treated advanced gastric/gastroesophageal junction adenocarcinoma']","['paclitaxel', 'ramucirumab plus paclitaxel']","['Tumor response', 'median TtR', 'ORR', 'overall response (BOR), ORR, disease control rate (DCR), duration of response, time to response (TtR), change in tumor size, and associations of QoL with tumor shrinkage and BOR', 'tumor shrinkage', 'tumor response and stable disease', 'objective response rate (ORR', 'DCR', 'Tumor response and symptom palliation', 'quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}]",,0.0366139,Responses were more durable in the ramucirumab versus control arm (median 4.4 vs 2.8 months).,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Cascinu', 'Affiliation': 'Department of Oncology and Hematology, Modena University Hospital, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Bodoky', 'Affiliation': 'Department of Oncology, St. Laszlo Hospital, Budapest, Hungary.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Gastroenterology/Digestive Oncology, University Hospitals Gasthuisberg Leuven and KULeuven, Leuven, Belgium.'}, {'ForeName': 'Sang Cheul', 'Initials': 'SC', 'LastName': 'Oh', 'Affiliation': 'Korea University Guro Hospital, Seoul, Republic Of Korea.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Folprecht', 'Affiliation': 'Universitätsklinikum Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Sumitra', 'Initials': 'S', 'LastName': 'Ananda', 'Affiliation': 'Western Health, Melbourne, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Girotto', 'Affiliation': 'Faculdade de Medicina, Hospital de Base, São Paulo, Brazil.'}, {'ForeName': 'Zev A', 'Initials': 'ZA', 'LastName': 'Wainberg', 'Affiliation': 'University of California Los Angeles, California, USA.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Limon Miron', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Jaffer', 'Initials': 'J', 'LastName': 'Ajani', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wei', 'Affiliation': 'Statistics, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Astra M', 'Initials': 'AM', 'LastName': 'Liepa', 'Affiliation': 'Oncology, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carlesi', 'Affiliation': 'Oncology, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Emig', 'Affiliation': 'Oncology, Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'National Cancer Center Hospital East, Chiba, Japan.'}]",The oncologist,['10.1002/onco.13623']
2603,33274528,Maximum insertion torque loss after miniscrew placement in orthodontic patients -a randomized controlled trial.,"OBJECTIVES
To compare torque recordings of immediately loaded orthodontic miniscrews between insertion time and different post-placement timepoints (2 weeks, 4 weeks and removal time respectively).
SETTING AND SAMPLE POPULATION
Parallel trial with an allocation ratio of 1:1. Eligibility criteria: needs of fixed orthodontic treatment, no systemic disease, absence of using drugs altering bone metabolism.
MATERIAL AND METHODS
Patients received miniscrews, 2.0 mm diameter and 10 mm length. All miniscrews underwent interradicular placement; and they were placed in the maxilla or in the mandible, palatally or buccally. No pre-drilling was performed. Miniscrews were loaded immediately after the insertion and were used for distalization, intrusion, extrusion, mesialization or indirect anchorage. Patients were randomly divided in three groups. For each patient, Maximum Insertion Torque (MIT) was evaluated at baseline. MIT was measured again after 2 weeks and after 4 weeks by tightening the screw a quarter of turn in Group 1 and 2 respectively. At the end of the treatment, maximal removal torque was evaluated in Group 3. Torque variation with respect to insertion time was considered as the primary outcome. Baseline and longitudinal differences were tested using the linear mixed effects (LME) model.
RESULTS
47 patients and 74 miniscrews were followed up. An association existed between maximum insertion torque and the observation time. A torque decrease of 26.9% and 30% after 2 weeks was observed for mandibular and maxillary miniscrews respectively. After 1 month torque values were similar to the baseline records. The overall success rate was 79.7%. No serious harm was observed.
CONCLUSIONS
Maximum insertion torque undergoes a loss during the first two weeks and its values may depend on the insertion site and the anchorage purpose. Removal torque value is almost the same as the initial torque after one month.",2020,A torque decrease of 26.9% and 30% after 2 weeks was observed for mandibular and maxillary miniscrews respectively.,"['47 patients and 74 miniscrews were followed up', 'Patients received miniscrews, 2.0 mm diameter and 10 mm length', 'orthodontic patients']",[],"['MIT', 'overall success rate', 'Maximum Insertion Torque (MIT', 'maximal removal torque', 'Maximum insertion torque loss', 'Removal torque value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}]",[],"[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0800431,A torque decrease of 26.9% and 30% after 2 weeks was observed for mandibular and maxillary miniscrews respectively.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Migliorati', 'Affiliation': 'Orthodontics Department, School of Dentistry, University of Genova, Genova, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Drago', 'Affiliation': 'Orthodontics Department, School of Dentistry, University of Genova, Genova, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Amorfini', 'Affiliation': 'Private Practice, Gallarate, MI, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Nucera', 'Affiliation': 'Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Silvestrini-Biavati', 'Affiliation': 'Orthodontics Department, School of Dentistry, University of Genova, Genova, Italy.'}]",Orthodontics & craniofacial research,['10.1111/ocr.12449']
2604,33274523,Challenges and reflections from a multi-centre trial of a psycho-oncology intervention to support shared decision-making in breast reconstruction.,,2020,,[],['psycho-oncology intervention'],[],[],"[{'cui': 'C4505070', 'cui_str': 'Psychooncology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0308771,,"[{'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Tollow', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Paraskeva', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Applied Statistics Group, Department of Engineering, Design and Mathematics, University of the West of England, Bristol, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'Centre for Public Health and Wellbeing, University of the West of England, Bristol, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Cox', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harcourt', 'Affiliation': 'Centre for Appearance Research, University of the West of England, Bristol, UK.'}]",European journal of cancer care,['10.1111/ecc.13384']
2605,33274518,Establishment of a Disease-Drug Trial Model for Postmenopausal Osteoporosis: A Zoledronic Acid Case Study.,"Costly and lengthy clinical trials hinder the development of safe and effective treatments for postmenopausal osteoporosis. To reduce the expense associated with these trials, we established a mechanistic disease-drug trial model for postmenopausal osteoporosis that can predict phase 3 trial outcome based on short-term bone turnover marker data. To this end, we applied a previously developed model for tibolone to bisphosphonates using zoledronic acid as paradigm compound by (1) linking the mechanistic bone cell interaction model to bone turnover markers as well as bone mineral density in lumbar spine and total hip, (2) employing a mechanistic disease progression function, and (3) accounting for zoledronic acid's mechanism of action. Once developed, we fitted the model to clinical trial data of 581 postmenopausal women receiving (1) 5-mg zoledronic acid in year 1 and saline in year 2, (2) 5-mg zoledronic acid in year 1 and year 2, or (3) placebo (saline), calcium (500 mg), and vitamin D (400 IU). All biomarker data was fitted reasonably well, with no apparent bias or model misspecification. Age, years since menopause, and body mass index at baseline were identified as significant covariates. In the future, the model can be modified to explore the link between short-term biomarkers and fracture risk.",2020,"All biomarker data was fitted reasonably well, with no apparent bias or model misspecification.","['Postmenopausal Osteoporosis', 'postmenopausal osteoporosis', '581 postmenopausal women receiving (1) 5-mg']","['zoledronic acid', 'placebo (saline), calcium (500\xa0mg), and vitamin D']",[],"[{'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]",[],581.0,0.0511257,"All biomarker data was fitted reasonably well, with no apparent bias or model misspecification.","[{'ForeName': 'Yi Ting Kayla', 'Initials': 'YTK', 'LastName': 'Lien', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA.'}, {'ForeName': 'Kumpal', 'Initials': 'K', 'LastName': 'Madrasi', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Samant', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA.'}, {'ForeName': 'Myong-Jin', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.'}, {'ForeName': 'Yaning', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1748']
2606,33274441,Immersion and haptic feedback impacts on dental anesthesia technical skills virtual reality training.,"OBJECTIVES
Administering anesthesia to the inferior alveolar nerve is 1 of the most stressful processes in dental training. Most studies using virtual reality (VR) for dental training have used non-immersive technologies. The purpose of this work is to assess the impact of immersive technologies on skills training.
METHODS
On May 2019, an experimental study was conducted with 163 clinical dental students, divided into 4 groups across 2 phases (preceptorship and training) with haptic feedback either On or Off. The participants trained on the inferior alveolar dental anesthesia procedure in a haptic VR simulator. Their technical skills were evaluated in terms of needle insertion features which were computed from a haptic device providing kinematic data. Also, the participants reported their subjective experience with syringe handling and simulator sickness. A machine learning method was implemented to automatically evaluate the needle insertion point performance of the student.
RESULTS
Groups receiving immersive preceptorship and/or immersive training showed more accuracy and confidence in administering the anesthesia. Participants perceived a high sense of realism with the haptic feedback when handling the syringe. The machine learning method was validated, with an accuracy of 84%, as a good classifier to assess a student's needle insertion point performance.
CONCLUSIONS
The immersive VR simulator allows the practice of the inferior alveolar nerve block under near real conditions and with immediate feedback to the dental student with respect to the needle insertion point. This machine learning based automatic evaluation provides a method to improve technical skills, contributing to dental training.",2020,The immersive VR simulator allows the practice of the inferior alveolar nerve block under near real conditions and with immediate feedback to the dental student with respect to the needle insertion point.,"['163 clinical dental students', 'participants trained on the inferior alveolar dental anesthesia procedure in a haptic VR simulator', 'dental anesthesia technical skills virtual reality training']","['haptic feedback either On or Off', 'immersive VR simulator', 'virtual reality (VR', 'immersive preceptorship and/or immersive training']",['accuracy and confidence'],"[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0032929', 'cui_str': 'Clinical Practicum'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0158474,The immersive VR simulator allows the practice of the inferior alveolar nerve block under near real conditions and with immediate feedback to the dental student with respect to the needle insertion point.,"[{'ForeName': 'Elen', 'Initials': 'E', 'LastName': 'Collaço', 'Affiliation': 'Computer and Digital Systems Engineering, Polytechnic School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Elisabeti', 'Initials': 'E', 'LastName': 'Kira', 'Affiliation': 'Department of Statistics, Institute of Mathematics and Statistics, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas H', 'Initials': 'LH', 'LastName': 'Sallaberry', 'Affiliation': 'Computer and Digital Systems Engineering, Polytechnic School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anna C M', 'Initials': 'ACM', 'LastName': 'Queiroz', 'Affiliation': 'School of Education and Virtual Human Interaction Lab, Stanford University, California, United States.'}, {'ForeName': 'Maria A A M', 'Initials': 'MAAM', 'LastName': 'Machado', 'Affiliation': 'Orthodontics and Public Health, Dentistry School, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Oswaldo', 'Initials': 'O', 'LastName': 'Crivello', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Romero', 'Initials': 'R', 'LastName': 'Tori', 'Affiliation': 'Computer and Digital Systems Engineering, Polytechnic School, University of São Paulo, São Paulo, Brazil.'}]",Journal of dental education,['10.1002/jdd.12503']
2607,33274389,"Residual, differential neurobehavioral deficits linger after multiple recovery nights following chronic sleep restriction or acute total sleep deprivation.","STUDY OBJECTIVES
The amount of recovery sleep needed to fully restore well-established neurobehavioral deficits from sleep loss remains unknown, as does whether the recovery pattern differs across measures after total sleep deprivation (TSD) and chronic sleep restriction (SR).
METHODS
In total, 83 adults received two baseline nights (10-12-hour time in bed [TIB]) followed by five 4-hour TIB SR nights or 36-hour TSD and four recovery nights (R1-R4; 12-hour TIB). Neurobehavioral tests were completed every 2 hours during wakefulness and a Maintenance of Wakefulness Test measured physiological sleepiness. Polysomnography was collected on B2, R1, and R4 nights.
RESULTS
TSD and SR produced significant deficits in cognitive performance, increases in self-reported sleepiness and fatigue, decreases in vigor, and increases in physiological sleepiness. Neurobehavioral recovery from SR occurred after R1 and was maintained for all measures except Psychomotor Vigilance Test (PVT) lapses and response speed, which failed to completely recover. Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor. After TSD and SR, R1 recovery sleep was longer and of higher efficiency and better quality than R4 recovery sleep.
CONCLUSIONS
PVT impairments from SR failed to reverse completely; by contrast, vigor did not recover after TSD; all other deficits were reversed after sleep loss. These results suggest that TSD and SR induce sustained, differential biological, physiological, and/or neural changes, which remarkably are not reversed with chronic, long-duration recovery sleep. Our findings have critical implications for the population at large and for military and health professionals.",2020,"Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor.",['chronic sleep restriction or acute total sleep deprivation'],[],"['self-reported sleepiness and fatigue', 'Psychomotor Vigilance Test (PVT) lapses and response speed', 'Neurobehavioral recovery from TSD', 'Neurobehavioral tests', 'cognitive performance', 'Neurobehavioral recovery from SR', 'physiological sleepiness', 'total sleep deprivation (TSD) and chronic sleep restriction (SR', 'SR, R1 recovery sleep']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",83.0,0.0223471,"Neurobehavioral recovery from TSD occurred after R1 and was maintained for all cognitive and self-reported measures, except for vigor.","[{'ForeName': 'Erika M', 'Initials': 'EM', 'LastName': 'Yamazaki', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Antler', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Charlotte R', 'Initials': 'CR', 'LastName': 'Lasek', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Biological Rhythms Research Laboratory, Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}]",Sleep,['10.1093/sleep/zsaa224']
2608,33274388,Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial.,"OBJECTIVES
To compare early headgear activator treatment of Class II malocclusion with excessive overjet with untreated control subjects in terms of the primary outcomes overjet and overbite as well as the effect regarding oral-health-related quality of life (OHRQoL), lip closure, incidence of trauma, and skeletal changes.
TRIAL DESIGN
Two-arm parallel group single-centre randomized controlled trial.
MATERIAL AND METHODS
A total of 60 children (mean age 9.5 years) presenting a Class II malocclusion with excessive overjet were recruited. The trial was designed as intention-to-treat and the participants randomized by an independent person not involved in the trial to either early treatment with headgear activator or to an untreated control group (UG). Dental and skeletal variables as well as registrations of OHRQoL, lip closure, and incidence of trauma were recorded. For the treatment group, data were registered at baseline before treatment and when treatment was finished, corresponding to approximately 2 years. For the UG, registrations were made at baseline and at 11 years of age. Observers were blinded to treatment allocation when assessing outcomes.
RESULTS
Early treatment with headgear activator significantly decreased overjet and improved molar relationship when compared with untreated controls. The effects were primarily due to dentoalveolar changes. Early treatment had no evident effect regarding OHRQoL, lip closure, or incidence of trauma. Lack of cooperation resulted in unsuccessful treatments for 27% of the patients.
LIMITATIONS
The trial was a single-centre trial and can thus be less generalizable.
CONCLUSIONS
The main treatment effect of early headgear activator treatment of Class II malocclusion with excessive overjet is reduction of overjet.
TRIAL REGISTRATION
NCT04508322.",2020,significantly decreased overjet and improved molar relationship when compared with untreated controls.,"['Class II malocclusion with excessive overjet', 'Class II malocclusion with excessive overjet with untreated control subjects', '60 children (mean age 9.5 years) presenting a Class II malocclusion with excessive overjet were recruited']","['headgear activator', 'headgear activator or to an untreated control group (UG']","['overjet and improved molar relationship', 'registrations of OHRQoL, lip closure, and incidence of trauma', 'OHRQoL, lip closure, or incidence of trauma', 'oral-health-related quality of life (OHRQoL), lip closure, incidence of trauma, and skeletal changes']","[{'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0596028', 'cui_str': 'Horizontal overbite'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0596028', 'cui_str': 'Horizontal overbite'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1293493', 'cui_str': 'Lip closure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",60.0,0.268399,significantly decreased overjet and improved molar relationship when compared with untreated controls.,"[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Kallunki', 'Affiliation': 'The Center for Orthodontics and Pedodontics, County Council Östergötland, Norrköping, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bondemark', 'Affiliation': 'Department of Orthodontics, Faculty of Odontology, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Paulsson', 'Affiliation': 'Department of Orthodontics, Faculty of Odontology, Malmö University, Malmö, Sweden.'}]",European journal of orthodontics,['10.1093/ejo/cjaa073']
2609,33274381,Disposition of urinary and serum steroid metabolites in response to testosterone administration in healthy women.,"CONTEXT
Little is known about how exogenous testosterone (T) affects the steroid profile in women. More knowledge would give the anti-doping community keys on how to interpret tests and detect doping.
OBJECTIVE
To investigate the steroid profile in serum and urine in young healthy women after testosterone administration.
METHODS
In a randomized, double-blind, placebo-controlled study, 48 healthy young women, were assigned to treatment with T cream (10 mg) or placebo (1:1) for 10 weeks. Urine and blood were collected before and at end of treatment. Serum steroids were analyzed with LC-MS/MS, and urine levels of T, epitestosterone (E) and metabolites included in the Athlete Biological Passport (ABP) were analyzed with GC-MS/MS.
RESULTS
In serum, T and dihydrotestosterone levels increased, whereas sex-hormone-binding globulin and 17-hydroxyprogesterone decreased after T treatment as compared to placebo. In urine, T and 5α-androstanediol increased in the T group. The median T increase in serum was 5.0-fold (range 1.2-18.2) and correlated to a 2.2-fold (range 0.4-14.4) median increase in T/E in urine (rs=0.76). Only two of the 24 women receiving T reached the T/E cut-off ratio of 4, while when the results were added to the ABP, six of 15 subjects showed atypically high T/E (40%). In comparison, 22/24 women in the T group increased serum T more than 99.9% of the upper confidence limit of non-treated values.
CONCLUSION
It seems as T/E ratio is not sufficient to detect exogenous testosterone in women. Serum total T concentrations could serve as a complementary marker of doping.",2020,"In serum, T and dihydrotestosterone levels increased, whereas sex-hormone-binding globulin and 17-hydroxyprogesterone decreased after T treatment as compared to placebo.","['women', 'young healthy women after testosterone administration', '48 healthy young women', 'healthy women']","['testosterone', 'T cream', 'placebo']","['Urine and blood', 'serum T', 'LC-MS/MS, and urine levels of T, epitestosterone (E) and metabolites included in the Athlete Biological Passport (ABP', 'median T increase in serum', 'serum, T and dihydrotestosterone levels', 'Serum steroids', 'urine, T and 5α-androstanediol', 'sex-hormone-binding globulin and 17-hydroxyprogesterone', 'Serum total T concentrations']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014594', 'cui_str': 'Epitestosterone'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0373601', 'cui_str': 'Dihydrotestosterone level'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0486333', 'cui_str': 'Androstanediol'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",48.0,0.113073,"In serum, T and dihydrotestosterone levels increased, whereas sex-hormone-binding globulin and 17-hydroxyprogesterone decreased after T treatment as compared to placebo.","[{'ForeName': 'Jona Elings', 'Initials': 'JE', 'LastName': 'Knutsson', 'Affiliation': 'Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Andersson', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lasse Vestli', 'Initials': 'LV', 'LastName': 'Baekken', 'Affiliation': 'Nordic Athlete Passport Management Unit, Anti-Doping Norway, Sognsveien 75F, Oslo, Norway.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Pohanka', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Ekström', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Angelica Lindén', 'Initials': 'AL', 'LastName': 'Hirschberg', 'Affiliation': 'Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm, Sweden.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa904']
2610,33274308,A Community-Based School Nutrition Intervention Improves Diet Diversity and School Attendance in Palestinian Refugee Schoolchildren in Lebanon.,"Background
School feeding programs have the potential to supply children with healthy school food, alleviate short-term hunger, and improve children's educational outcomes.
Objectives
We linked community kitchens to a subsidized school snack intervention and assessed the impact of this intervention on nutritional (diet diversity, hemoglobin, and anthropometry) and educational (attendance and academic performance) outcomes of Palestinian refugee schoolchildren.
Methods
We collected data from 1362 students (aged 5-15 y) and their parents at baseline, and at an 8-mo follow-up in 2 control and 2 intervention schools. We conducted linear, logistic, and negative binomial regression analyses to assess changes in outcomes of children participating in the intervention schools compared with children in control schools (intention-to-treat). We also assessed the impact of the snack intervention in children who participated ≥50% of the time (HP, high-participation) compared with those who participated <50% (LP, low-participation), or who only received nutrition education (control) (per protocol). All the analyses were adjusted for child age and gender, maternal education, household expenditure, and school-level clustering effect.
Results
At endline, there were 648 children in the control group, and within the intervention group, 260 children were LP and 454 were HP. There was a significantly greater increase in overall diet diversity score and dairy consumption in the HP group compared with controls. Both LP and HP groups were more likely to consume proteins, and less likely to consume desserts than controls. Furthermore, the HP group had a significant increase in hemoglobin, and both LP and HP groups had a significant decrease in school absenteeism compared with controls.
Conclusions
This community-based school nutrition intervention had a positive impact on diet diversity, hemoglobin, and school attendance of children.",2020,There was a significantly greater increase in overall diet diversity score and dairy consumption in the HP group compared with controls.,"['children participating in the intervention schools compared with children in control schools (intention-to-treat', '1362 students (aged 5-15 y) and their parents at baseline, and at an 8-mo follow-up in 2 control and 2 intervention schools', 'Palestinian Refugee Schoolchildren in Lebanon', '648 children in the control group, and within the intervention group, 260 children were LP and 454 were HP', 'children who participated ≥50% of the time (HP, high-participation) compared with those who participated <50% (LP, low-participation), or who only received nutrition education (control) (per protocol', 'Palestinian refugee schoolchildren']","['School Nutrition Intervention', 'snack intervention']","['diet diversity, hemoglobin, and school attendance of children', 'hemoglobin', 'overall diet diversity score and dairy consumption', 'school absenteeism', 'Diet Diversity and School Attendance', 'nutritional (diet diversity, hemoglobin, and anthropometry) and educational (attendance and academic performance) outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0282539', 'cui_str': 'Palestinians'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",260.0,0.0405297,There was a significantly greater increase in overall diet diversity score and dairy consumption in the HP group compared with controls.,"[{'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Jamaluddine', 'Affiliation': 'Center for Research on Population and Health, American University of Beirut, Beirut, Lebanon.'}, {'ForeName': 'Jowel', 'Initials': 'J', 'LastName': 'Choufani', 'Affiliation': 'The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Amelia Reese', 'Initials': 'AR', 'LastName': 'Masterson', 'Affiliation': 'CitySeed, Inc., New Haven, CT, USA.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Hoteit', 'Affiliation': 'Department of Family Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Sahyoun', 'Affiliation': 'Department of Nutrition and Food Science, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Ghattas', 'Affiliation': 'Center for Research on Population and Health, American University of Beirut, Beirut, Lebanon.'}]",Current developments in nutrition,['10.1093/cdn/nzaa164']
2611,33274260,Work of breathing during arm bracing in normal male subjects.,"Objective
Although chronic obstructive pulmonary disease patients get relief from their dyspnea by arm bracing, the mechanics of this effect are unknown. This study aimed to investigate the mechanisms by which arm bracing affects dyspnea by measuring the work of breathing (WOB) in the arm bracing posture.
Methods
Six normal male subjects were studied in two standing postures: erect and with their arms braced. For the arm bracing posture, the subjects leaned forward with their arms stretched and rested their hands on a platform. Respiratory frequency was set at 20 tidal breaths/min with the use of a metronome, and tidal volume was set at 1 L by observing the lung volume on a monitor. All the subjects randomly adopted the two postures, and a preset respiratory pattern was measured for 30 s in each posture. Lung volume and flow rate were measured using a hot-wire flowmeter. Esophageal pressure was measured using a 12-cm balloon catheter. The WOB was estimated using modified Campbell diagrams.
Results
Lung volume increased and inspiratory resistive WOB decreased, while inspiratory elastic WOB increased significantly with arm bracing compared with that of the erect posture ( P < 0.05).
Conclusion
Arm bracing posture increases the chest wall expansion thereby increasing the end-expiratory lung volume and decreasing the inspiratory resistive WOB among healthy individuals.",2020,"Results
Lung volume increased and inspiratory resistive WOB decreased, while inspiratory elastic WOB increased significantly with arm bracing compared with that of the erect posture ( P < 0.05).
","['Methods\n\n\nSix normal male subjects', 'normal male subjects', 'chronic obstructive pulmonary disease patients', 'healthy individuals']",[],"['inspiratory resistive WOB', 'Esophageal pressure', 'Lung volume and flow rate', 'WOB', 'inspiratory elastic WOB']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0231953', 'cui_str': 'Lung volume'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}]",6.0,0.0225634,"Results
Lung volume increased and inspiratory resistive WOB decreased, while inspiratory elastic WOB increased significantly with arm bracing compared with that of the erect posture ( P < 0.05).
","[{'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Ogino', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Sasayama, Hyogo, Japan.'}, {'ForeName': 'Kyoshi', 'Initials': 'K', 'LastName': 'Mase', 'Affiliation': ""Department of Physical Therapy, Faculty of Nursing and Rehabilitation, Konan Women's University, Higashinada, Kobe, Hyogo, Japan.""}, {'ForeName': 'Shigefumi', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Department of Rehabilitation, Hyogo College of Medicine Sasayama Medical Center, Sasayama, Hyogo, Japan.'}, {'ForeName': 'Kazuhisa', 'Initials': 'K', 'LastName': 'Domen', 'Affiliation': 'Department of Rehabilitation Medicine, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan.'}]",Canadian journal of respiratory therapy : CJRT = Revue canadienne de la therapie respiratoire : RCTR,['10.29390/cjrt-2020-012']
2612,33274199,The Effects of Chewing Gum in Preventing Eyestrain.,"Purpose
To investigate the effects of chewing gum and tablet candy to reduce eyestrain in healthy individuals.
Materials and Methods
A double-blinded crossover trial was conducted. Forty-six healthy individuals (23 men, 23 women) between 20 and 59 years old, feeling eyestrain, were enrolled. Each 10-year age group included 12 individuals except the 30s group, which included 10 individuals. A visual task was performed on reading material displayed on a computer screen at a fixed distance for 60 min. Gum or tablet candy of two pieces were chewed for two 15-min periods starting 15 and 45 min after starting to read. Subjects chewed gum on Day 1 and tablet candy on Day 2, and vice versa. Primary outcome is as follows: subjective eye fatigue (eye tiredness, eye heaviness, blurred vision, double vision, and eye dryness) using a visual analog scale (VAS). Secondary outcomes are as follows: subjective accommodation from near and far points of accommodation measured with a D'ACOMO, spherical equivalent refraction, and eye dryness by analyzing ring break-up time (RBUT) measured with the RT-7000 Auto Ref-Topographer.
Results
The VAS scores of subjective eye fatigue were not significantly changed between chewing gum and tablet candy ( P = 0.397 - P = 0.909). Those scores of eye tiredness and eye heaviness were significantly longer before and after the visual task with tablet candy ( P = 0.013 and P = 0.025, respectively) but not with chewing gum. The changes of subjective accommodation were significantly lower after the visual task between chewing gum and candy ( P = 0.043). There were significant differences among each age group (20 s vs. 30 s, P = 0.594; 20 s vs. 40 s, P = 0.002; 20 s vs. 50 s, P = 0.002). After reading, the changes of spherical equivalent refraction did not indicate a shift toward myopia ( P = 0.267). In the RBUT, there were no significant differences between the samples ( P = 0.680).
Conclusions
Chewing gum helps improve the ability of the eye to focus, especially in young adults.",2020,The VAS scores of subjective eye fatigue were not significantly changed between chewing gum and tablet candy ( P = 0.397 - P = 0.909).,"['healthy individuals', 'young adults', 'Forty-six healthy individuals (23 men, 23 women) between 20 and 59 years old, feeling eyestrain, were enrolled', 'Each 10-year age group included 12 individuals except the 30s group, which included 10 individuals']","['Gum or tablet candy', 'chewing gum and tablet candy', 'Chewing Gum']","['subjective accommodation', 'follows: subjective eye fatigue (eye tiredness, eye heaviness, blurred vision, double vision, and eye dryness) using a visual analog scale (VAS', ""follows: subjective accommodation from near and far points of accommodation measured with a D'ACOMO, spherical equivalent refraction, and eye dryness by analyzing ring break-up time (RBUT) measured with the RT-7000 Auto Ref-Topographer"", 'VAS scores of subjective eye fatigue', 'scores of eye tiredness and eye heaviness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0006855', 'cui_str': 'Candy'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0004095', 'cui_str': 'Accommodative asthenopia'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0012569', 'cui_str': 'Diplopia'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1720532', 'cui_str': 'Ocular accommodation far point'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",46.0,0.034677,The VAS scores of subjective eye fatigue were not significantly changed between chewing gum and tablet candy ( P = 0.397 - P = 0.909).,"[{'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Asakawa', 'Affiliation': 'Department of Orthoptics and Visual Science, School of Allied Health Sciences, Kitasato University, Kanagawa, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Kanno', 'Affiliation': 'LOTTE Co., Ltd, Central Laboratory, Saitama, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': 'LOTTE Co., Ltd, Central Laboratory, Saitama, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Osawa', 'Affiliation': 'LOTTE Co., Ltd, Central Laboratory, Saitama, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Orthoptics and Visual Science, School of Allied Health Sciences, Kitasato University, Kanagawa, Japan.'}]",BioMed research international,['10.1155/2020/2470473']
2613,33274160,Low-Intensity Shockwave Therapy in the Treatment of Erectile Dysfunction.,"Introduction Low-intensity shockwave therapy (LISWT) may improve erectile function in patients with mild to moderate erectile dysfunction (ED). Currently there is a paucity of research and prospective data on the utilization of LISWT in patients with ED. We present the results of our phase II clinical trial of LISWT with short-term follow-up in a cohort of patients with mild to moderate vasculogenic ED. Methods We obtained IRB approval and prospectively enrolled patients with mild to moderate vasculogenic ED. Baseline International Index of Erectile Function (IIEF) scores and peak systolic velocities (PSV) of cavernosal arteries measured on duplex penile ultrasound were obtained prior to treatment. Treatment included 6600 total shocks per session, for a total of six consecutive weekly treatment sessions. Baseline Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were obtained at the completion of the treatment course. IIEF, EDITS and PSV were evaluated again at one-month follow-up. Clinical significance was defined as a median IIEF score increase of four points from baseline or an EDITS total score increase to greater than 65 or increase of greater than ten from baseline. Treatment success was evaluated on an individual basis and defined by a clinically significant improvement in questionnaire score. Results A total of 25 patients were enrolled in the trial, with 22 patients reporting for one-month follow-up. 68% (15/22) of patients demonstrated treatment success. In the cohort there was improvement in median EDITS from 61 (IQR 49-92) to 73 (IQR 43-49), which did meet criteria for clinical significance, but did not reach statistical significance (p = 0.74). IIEF improved from a median of 13 (IQR 12-19) to 18 (IQR 14-25), which did reach statistical significance (p = 0.011). On duplex ultrasound, mean cavernosal artery PSV increased from 34.3 cm/s (IQR 25.7-51.1) to 38.0 cm/s (IQR 31.6-45.1); however, these differences were statistically insignificant (p = 0.986). Of the 25 patients undergoing LISWT, two reported discomfort during treatment sessions, which subsided after repositioning the device without alterations in energy delivered. Conclusion LISWT may be a safe and potentially efficacious clinical modality for treatment of patients with mild to moderate vasculogenic ED demonstrating increases in cavernosal artery PSV and improvements in IIEF and EDITS scores in short-term follow-up. Longitudinal studies with increased power are needed to better evaluate the long-term efficacy and cost-efficiency of this therapy.",2020,"On duplex ultrasound, mean cavernosal artery PSV increased from 34.3 cm/s (IQR 25.7-51.1) to 38.0 cm/s (IQR 31.6-45.1); however, these differences were statistically insignificant (p = 0.986).","['Erectile Dysfunction', 'A total of 25 patients were enrolled in the trial, with 22 patients reporting for one-month follow-up', '25 patients undergoing', 'enrolled patients with mild to moderate vasculogenic ED', 'patients with mild to moderate erectile dysfunction (ED', 'patients with mild to moderate vasculogenic ED', 'patients with ED']","['LISWT', 'Low-Intensity Shockwave Therapy', 'Introduction Low-intensity shockwave therapy (LISWT']","['duplex ultrasound, mean cavernosal artery PSV', 'median IIEF score increase', 'questionnaire score', 'IIEF', 'Baseline Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores', 'erectile function', 'cavernosal artery PSV', 'Baseline International Index of Erectile Function (IIEF) scores and peak systolic velocities (PSV) of cavernosal arteries measured on duplex penile ultrasound', 'IIEF, EDITS and PSV']","[{'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242845', 'cui_str': 'Duplex ultrasound'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]",25.0,0.0421636,"On duplex ultrasound, mean cavernosal artery PSV increased from 34.3 cm/s (IQR 25.7-51.1) to 38.0 cm/s (IQR 31.6-45.1); however, these differences were statistically insignificant (p = 0.986).","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lurz', 'Affiliation': 'Urological Surgery, Mainline Health, Philadelphia, USA.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Dreher', 'Affiliation': 'Urology, Mainline Health, Philadelphia, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Levy', 'Affiliation': 'Urology, Mainline Health, Philadelphia, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'McGreen', 'Affiliation': 'Urology, Mainline Health, Philadelphia, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Piraino', 'Affiliation': 'Urology, Mainline Health, Philadelphia, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Brevik', 'Affiliation': 'Urology, Kansas City University of Medicine and Biosciences, Kansas City, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'Urology, Mainline Health, Philadelphia, USA.'}, {'ForeName': 'Laurence H', 'Initials': 'LH', 'LastName': 'Belkoff', 'Affiliation': 'Surgery, Mainline Health, Philadelphia, USA.'}]",Cureus,['10.7759/cureus.11286']
2614,33274135,A Comparative Study Between Single-Incision Laparoscopic Appendicectomy Using Conventional Instruments and Glove-Port (SILACIG) and Conventional Multiport Laparoscopic Appendicectomy (CMLA).,"Introduction Appendicectomy is the most common surgical procedure. Conventional laparoscopic appendicectomy being time-tested, attempts were made to make it less invasive. Single-incision laparoscopic appendicectomy is the most recent trend. The present study is conducted with the aim to compare surgical outcomes between single-incision laparoscopic appendicectomy using conventional instruments and glove-port (SILACIG) with conventional multiport laparoscopic appendicectomy (CMLA). Materials and methods A total of 80 patients with appendicitis were recruited and underwent SILACIG (n=40) and CMLA (n=40). They were monitored for operative time, time of oral intake, pain on the second postoperative day, day of discharge, return to work, and scar size after two months. Results There was no significant difference between SILACIG and CMLA in terms of the time of oral intake, day of discharge, and return to work. Operative time was significantly more in the SILACIG group as compared to CMLA. Pain on the second postoperative day was less than CMLA, and the size of the operative scar was significantly smaller than 2 cm in the SILACIG group as compared to the CMLA group. Conclusion SILACIG is a feasible, safe, and cost-effective technique. It is comparable with CMLA in terms of preoperative diagnosis, postoperative oral intake, hospitalization period, and return to work. It shows less pain on the second postoperative day and cosmetic benefit but requires more operative time than CMLA.",2020,Operative time was significantly more in the SILACIG group as compared to CMLA.,['80 patients with appendicitis were recruited and underwent SILACIG (n=40) and CMLA (n=40'],"['CMLA', 'single-incision laparoscopic appendicectomy using conventional instruments and glove-port (SILACIG) with conventional multiport laparoscopic appendicectomy (CMLA', 'Single-incision laparoscopic appendicectomy', 'Conventional laparoscopic appendicectomy', 'Single-Incision Laparoscopic Appendicectomy Using Conventional Instruments and Glove-Port (SILACIG) and Conventional Multiport Laparoscopic Appendicectomy (CMLA']","['preoperative diagnosis, postoperative oral intake, hospitalization period, and return to work', 'operative time, time of oral intake, pain on the second postoperative day, day of discharge, return to work, and scar size', 'Pain', 'size of the operative scar', 'Operative time', 'time of oral intake, day of discharge, and return to work']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0452253', 'cui_str': 'Port'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0452253', 'cui_str': 'Port'}]","[{'cui': 'C1318968', 'cui_str': 'Pre-op diagnosis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",80.0,0.0306763,Operative time was significantly more in the SILACIG group as compared to CMLA.,"[{'ForeName': 'Ahamed', 'Initials': 'A', 'LastName': 'Muneef', 'Affiliation': 'Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, IND.'}, {'ForeName': 'Uday', 'Initials': 'U', 'LastName': 'Kumbhar', 'Affiliation': 'Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, IND.'}, {'ForeName': 'Chellappa', 'Initials': 'C', 'LastName': 'Vijayakumar', 'Affiliation': 'Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, IND.'}, {'ForeName': 'Oseen', 'Initials': 'O', 'LastName': 'Shaikh', 'Affiliation': 'Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, IND.'}]",Cureus,['10.7759/cureus.11257']
2615,33273816,Contrastive Analysis of Neuropsychology and Personality Characteristics of Male Lacunar Infarction Patients with Hazardous Drinking and Non-Hazardous Drinking.,"Objective
To compare the differences in neuropsychological and personality characteristics between male patients with lacunar infarction with hazardous drinking and non-hazardous drinking.
Methods
From May to October 2016, a total of 124 male outpatients and inpatients with lacunar infarction were selected in the Department of Neurology, Tongji Hospital, and they were divided into a hazardous drinking group (HD group, n=52) and a non-hazardous drinking group (NHD group, n=72) according to alcohol consumption habits. General information, MoCA score, EPQ score and SCL-90 score were compared between the two groups.
Results
Incidence of cognitive disorder in the HD group and NHD group was 59.6% and 56.9% respectively, showing no significant difference (P>0.05). Scores of visuospatial and executive function, memory, attention and total MoCA score in the HD group were significantly lower than those in the NHD group (P<0.05), while no significant difference in naming, language, abstract thinking or orientation was found between the two groups (P>0.05). Scores of extroversion and introversion, neuroticism and psychoticism in the HD group were significantly higher than those in the NHD group (P<0.05), while no significant difference in lie or feint score was found between the two groups (P>0.05). Scores of somatization, interpersonal sensitivity, anxiety, hostility, bigotry and psychoticism factors, and total SCL-90 score in the HD group were significantly higher than those in the NHD group (P<0.05), while no significant difference in scores of obsessive-compulsive, depression and terror factors were found between the two groups (P>0.05).
Conclusion
Compared with male patients with lacunar infarction with non-hazardous drinking, male lacunar infarction patients with hazardous drinking showed worse visuospatial and executive function, memory, attentiveness, cognitive function and mental health status, with more obvious change of personality, thus extra attention is needed for male lacunar infarction patients with hazardous drinking.",2020,"Scores of visuospatial and executive function, memory, attention and total MoCA score in the HD group were significantly lower than those in the NHD group (P<0.05), while no significant difference in naming, language, abstract thinking or orientation was found between the two groups (P>0.05).","['Male Lacunar Infarction Patients with Hazardous Drinking and Non-Hazardous Drinking', '124 male outpatients and inpatients with lacunar infarction were selected in the Department of Neurology, Tongji Hospital, and they were divided into a', 'male patients with lacunar infarction with hazardous drinking and non-hazardous drinking', 'male lacunar infarction patients with hazardous drinking', 'male patients with lacunar infarction with non-hazardous drinking, male lacunar infarction patients with hazardous drinking']","['hazardous drinking group (HD group, n=52) and a non-hazardous drinking group (NHD group, n=72) according to alcohol consumption habits']","['naming, language, abstract thinking or orientation', 'Incidence of cognitive disorder', 'scores of obsessive-compulsive, depression and terror factors', 'Scores of extroversion and introversion, neuroticism and psychoticism', 'Scores of somatization, interpersonal sensitivity, anxiety, hostility, bigotry and psychoticism factors, and total SCL-90 score', 'General information, MoCA score, EPQ score and SCL-90 score', 'lie or feint score', 'worse visuospatial and executive function, memory, attentiveness, cognitive function and mental health status', 'Scores of visuospatial and executive function, memory, attention and total MoCA score']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0333559', 'cui_str': 'Lacunar infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0432214', 'cui_str': 'Namaqualand hip dysplasia'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]","[{'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0459920', 'cui_str': 'Ability to think abstractly'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015382', 'cui_str': 'Extroversion, Psychological'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C1842981', 'cui_str': 'Neuroticism Traits'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0233413', 'cui_str': 'Attentiveness'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",124.0,0.0161459,"Scores of visuospatial and executive function, memory, attention and total MoCA score in the HD group were significantly lower than those in the NHD group (P<0.05), while no significant difference in naming, language, abstract thinking or orientation was found between the two groups (P>0.05).","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing 100053, People's Republic of China.""}, {'ForeName': 'Zhandong', 'Initials': 'Z', 'LastName': 'Qiu', 'Affiliation': ""Department of Neurology, Xuanwu Hospital of Capital Medical University, Beijing 100053, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Emergency Medicine, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, People's Republic of China.""}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S254998']
2616,33273714,Rapid lateral flow immunoassay for the fluorescence detection of SARS-CoV-2 RNA.,"The coronavirus disease 2019 (COVID-19) pandemic has highlighted the need for rapid and accurate nucleic acid detection at the point of care. Here, we report an amplification-free nucleic acid immunoassay, implemented on a lateral flow strip, for the fluorescence detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA in less than one hour. The assay uses DNA probes that are designed to bind to the conserved open reading frame 1ab (ORF1ab), envelope protein (E) and the nucleocapsid (N) regions of the SARS-CoV-2 genome, and a fluorescent-nanoparticle-labelled monoclonal antibody that binds to double-stranded DNA-RNA hybrids. In a multi-hospital randomized double-blind trial involving 734 samples (593 throat swabs and 141 sputum) provided by 670 individuals, the assay achieved sensitivities of 100% and specificities of 99% for both types of sample (ground truth was determined using quantitative PCR with reverse transcription). The inexpensive amplification-free detection of SARS-CoV-2 RNA should facilitate the rapid diagnosis of COVID-19 at the point of care.",2020,The inexpensive amplification-free detection of SARS-CoV-2 RNA should facilitate the rapid diagnosis of COVID-19 at the point of care.,['734 samples (593 throat swabs and 141 sputum) provided by 670 individuals'],[],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],[],734.0,0.153693,The inexpensive amplification-free detection of SARS-CoV-2 RNA should facilitate the rapid diagnosis of COVID-19 at the point of care.,"[{'ForeName': 'Daming', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Academy for Engineering & Technology, Fudan University, Shanghai, China. wangdm@sibet.ac.cn.'}, {'ForeName': 'Shaogui', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Xiamen Huaxia University, Xiamen, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Health Service and Transfusion Medicine, Beijing, China. lovechina1980@163.com.'}, {'ForeName': 'Youqin', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Wuhan No. 7 Hospital, Wuhan, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Wuhan No. 7 Hospital, Wuhan, China.'}, {'ForeName': 'Shimin', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'General Hospital of the Yangtze River Shipping, Wuhan, China.'}, {'ForeName': 'Shiguo', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""The Third People's Hospital of Hubei Province, Wuhan, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': 'Anbio (Xiamen) Biotechnology, Xiamen, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Xiamen Center for Disease Control and Prevention, Xiaman, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Xiamen Center for Disease Control and Prevention, Xiaman, China.'}, {'ForeName': 'Jieli', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Anbio (Xiamen) Biotechnology, Xiamen, China.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Anbio (Xiamen) Biotechnology, Xiamen, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Anbio (Xiamen) Biotechnology, Xiamen, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Anbio (Xiamen) Biotechnology, Xiamen, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Anbio (Xiamen) Biotechnology, Xiamen, China.'}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Institute of Health Service and Transfusion Medicine, Beijing, China.'}, {'ForeName': 'Yitong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Harbin Medical University, Harbin, China.'}, {'ForeName': 'Mingxuan', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Suzhou Institute of Biomedical Engineering and Technology (SIBET), Chinese Academy of Sciences, Suzhou, China.'}, {'ForeName': 'Yuguo', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Suzhou Institute of Biomedical Engineering and Technology (SIBET), Chinese Academy of Sciences, Suzhou, China. tangyg@sibet.ac.cn.'}]",Nature biomedical engineering,['10.1038/s41551-020-00655-z']
2617,33273644,Pupillometry pain index decreases intraoperative sufentanyl administration in cardiac surgery: a prospective randomized study.,"Pupillometry has proven effective for the monitoring of intraoperative analgesia in non-cardiac surgery. We performed a prospective randomized study to evaluate the impact of an analgesia-guided pupillometry algorithm on the consumption of sufentanyl during cardiac surgery. Fifty patients were included prior to surgery. General anesthesia was standardized with propofol and target-controlled infusions of sufentanyl. The standard group consisted of sufentanyl target infusion left to the discretion of the anesthesiologist. The intervention group consisted of sufentanyl target infusion based on the pupillary pain index. The primary outcome was the total intraoperative sufentanyl dose. The total dose of sufentanyl was lower in the intervention group than in the control group and (55.8 µg [39.7-95.2] vs 83.9 µg [64.1-107.0], p = 0.04). During the postoperative course, the cumulative doses of morphine (mg) were not significantly different between groups (23 mg [15-53] vs 24 mg [17-46]; p = 0.95). We found no significant differences in chronic pain at 3 months between the 2 groups (0 (0%) vs 2 (9.5%) p = 0.49). Overall, the algorithm based on the pupillometry pain index decreased the dose of sufentanyl infused during cardiac surgery.Clinical trial number: NCT03864016.",2020,"The total dose of sufentanyl was lower in the intervention group than in the control group and (55.8 µg [39.7-95.2] vs 83.9 µg [64.1-107.0], p = 0.04).","['Fifty patients were included prior to surgery', 'cardiac surgery']","['morphine', 'sufentanyl target infusion', 'propofol and target-controlled infusions of sufentanyl', 'analgesia-guided pupillometry algorithm']","['total intraoperative sufentanyl dose', 'chronic pain', 'pupillometry pain index', 'total dose of sufentanyl']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",50.0,0.0891623,"The total dose of sufentanyl was lower in the intervention group than in the control group and (55.8 µg [39.7-95.2] vs 83.9 µg [64.1-107.0], p = 0.04).","[{'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Berthoud', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Anouck', 'Initials': 'A', 'LastName': 'Appriou', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Ellouze', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Radhouani', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Tiberiu', 'Initials': 'T', 'LastName': 'Constandache', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Grosjean', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Bastien', 'Initials': 'B', 'LastName': 'Durand', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gounot', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Pierre-Alain', 'Initials': 'PA', 'LastName': 'Bahr', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nowobilski', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Belaid', 'Initials': 'B', 'LastName': 'Bouhemad', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France.'}, {'ForeName': 'Pierre-Grégoire', 'Initials': 'PG', 'LastName': 'Guinot', 'Affiliation': 'Anaesthesiology and Critical Care Department, Dijon University Hospital, 2 Bd Maréchal de Lattre de Tassigny, 21000, Dijon, France. guinotpierregregoire@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-78221-5']
2618,33273515,"Children's coordination of the ""sweet spot"" when striking a forehand is shaped by the equipment used.","Children's movement coordination is significantly influenced by the equipment used when performing multi-articular actions. Previously we reported that scaled equipment (smaller racket and a softer ball), but not full-sized equipment, promoted a functional coupling between upper arm and forearm angles in children performing a forehand. However, it remains unclear whether the shoulder-racket distance-which is controlled by this coupling-is a performance variable. This study therefore advanced previous research by examining whether the shoulder-racket distance is associated with performance. We also improved our understanding of how the shoulder-racket distance is controlled by including the hand-racket segment in our biomechanical model. Twenty-one children performed 40 forehands in a hitting for accuracy task. Participants were randomly divided into two groups-a scaled equipment group and a full-sized equipment group. Results revealed that the shoulder-racket distance was a performance variable, as evidenced by: (a) its variance reduced closer to ball impact, (b) its distance at ball impact, but not at the start of the forward swing, differentiated good from poor performance, and (c) its distance was similar for both groups, implying that there was a ""sweet spot"" for striking a ball, regardless of racket size. We also showed that it is the shoulder-racket vector in state-space (i.e., distance and angle) that differentiates good from poor performance. Finally, the manner in which the shoulder-racket distance was controlled differed between the groups, with scaled equipment promoting a more distal control than full-sized equipment. Implications for skill acquisition are discussed.",2020,"Results revealed that the shoulder-racket distance was a performance variable, as evidenced by: (a) its variance reduced closer to ball impact, (b) its distance at ball impact, but not at the start of the forward swing, differentiated good from poor performance, and (c) its distance was similar for both groups, implying that there was a ""sweet spot"" for striking a ball, regardless of racket size.",[],['scaled equipment group and a full-sized equipment group'],"['shoulder-racket distance', ""Children's movement coordination""]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",21.0,0.0197455,"Results revealed that the shoulder-racket distance was a performance variable, as evidenced by: (a) its variance reduced closer to ball impact, (b) its distance at ball impact, but not at the start of the forward swing, differentiated good from poor performance, and (c) its distance was similar for both groups, implying that there was a ""sweet spot"" for striking a ball, regardless of racket size.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Buszard', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia. tim.buszard@vu.edu.au.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Garofolini', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Whiteside', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Farrow', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'Machar', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': 'Game Insight Group, Tennis Australia, Melbourne, Australia.'}]",Scientific reports,['10.1038/s41598-020-77627-5']
2619,33273438,Effect of Topical Steroid on Swallowing following ACDF: Results of a Prospective Double-Blind Randomized Control Trial.,"STUDY DESIGN
Randomized, double-blinded, controlled trial OBJECTIVE.: To investigate the effectiveness of local intraoperative corticosteroids at decreasing the severity of swallowing difficulty following multilevel anterior cervical discectomy and fusion (ACDF).
SUMMARY OF BACKGROUND DATA
Dysphagia is a common complication after ACDF, and while for most patients the symptoms are mild and transient, some patients can suffer from severe dysphagia resulting in significant postoperative morbidity. Previous studies investigating the local application of corticosteroids are limited.
METHODS
This was a prospective, randomized, double-blinded, controlled trial of patients undergoing 2, 3, or 4 level ACDF for radiculopathy and/or myelopathy. Patients undergoing multilevel ACDF were randomized to receive local corticosteroid in the retropharyngeal space or placebo (no steroid). Dysphagia was assessed using validated outcomes including the Eating Assessment Tool-10 (Eat-10) and Swallowing Quality of Life (SWAL-QOL) Questionnaire both preoperatively and at 1 day (POD1), 2 days (POD2), and 1-month postoperatively.
RESULTS
One-hundred nine patients had a complete dataset available for analysis. Eat-10 scores were significantly lower in the Steroid group on POD2 (8 v. 16, p = 0.03) and 1-month postoperatively (2 v. 5, p = 0.03). A comparison of the individual SWAL-QOL subscale scores demonstrated that patients in the Steroid group had better scores than the Control group in various subscales at all postoperative time points. Significant differences were noted (always in favor of the Steroid group) in 40% of subscales on POD1, 60% of subscales on POD2, and 50% of subscales at 1-month postoperatively. The Control group never had a better SWAL-QOL subscale score at any time point postoperatively.
CONCLUSION
Local administration of corticosteroid after multilevel ACDF can decrease postoperative severity and symptomatology of dysphagia during the immediate postoperative period to 1 month postoperatively. The long-term effects of local steroid administration on fusion and other complications will need to be established in future studies.
LEVEL OF EVIDENCE
1.",2020,"Eat-10 scores were significantly lower in the Steroid group on POD2 (8 v. 16, p = 0.03) and 1-month postoperatively (2 v. 5, p = 0.03).","['patients undergoing 2, 3, or 4 level ACDF for radiculopathy and/or myelopathy', 'Swallowing following ACDF', 'Patients undergoing multilevel ACDF']","['corticosteroid', 'local intraoperative corticosteroids', 'local steroid', 'local corticosteroid in the retropharyngeal space or placebo (no steroid', 'Topical Steroid']","['Dysphagia', 'SWAL-QOL subscale score', 'Eat-10 scores', 'postoperative severity and symptomatology of dysphagia', 'individual SWAL-QOL subscale scores', 'Eating Assessment Tool-10 (Eat-10) and Swallowing Quality of Life (SWAL-QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456950', 'cui_str': 'Level 4'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0005956', 'cui_str': 'Bone marrow disorder'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0227147', 'cui_str': 'Structure of retropharyngeal area'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",109.0,0.583361,"Eat-10 scores were significantly lower in the Steroid group on POD2 (8 v. 16, p = 0.03) and 1-month postoperatively (2 v. 5, p = 0.03).","[{'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Hospital for Special Surgery, New York, NY, USA.'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Alluri', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Stein', 'Affiliation': ''}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Lebl', 'Affiliation': ''}, {'ForeName': 'Russel', 'Initials': 'R', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Lafage', 'Affiliation': ''}, {'ForeName': 'Tianna', 'Initials': 'T', 'LastName': 'Bennett', 'Affiliation': ''}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Lafage', 'Affiliation': ''}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Albert', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003825']
2620,33273421,Use of Simulation to Measure the Effects of Just-in-Time Information to Prevent Nursing Medication Errors: A Randomized Controlled Study.,"INTRODUCTION
Medication administration error (MAE) is the improper dispensing of medication. It is a significant contributor to the occurrence of medical errors. A novel systems thinking approach using a pediatric simulation and student nurses were used to evaluate the benefit of applying just-in-time information (JITI) to reduce medication errors. Just-in-time information applies highly focused information delivered when needed.
METHODS
A smart device app was developed to provide JITI medication administration information. The effect JITI had on MAE occurrence was assessed via a controlled study. The study population included 38 teams having 2 to 3 senior nursing students on each team. The teams were separated into a control and 2 intervention groups to complete a medication administration simulation.
RESULTS
The intervention groups (100%, N = 10) that made significant use of the JITI app demonstrated improved performance for medication administration over the control group. Familiarity with the app was pivotal to how frequently it was used and to the success of the groups in administering medications. Although those with access to the app having limited training successfully executed the simulation 27.3% (n = 11) of the time, those with extended training had a success rate of 77.8% (n = 9).
CONCLUSIONS
Providing JITI significantly reduced the occurrence of MAEs for these student nurses. Familiarity with the app, including extended training opportunities, contributed significantly to student success.",2020,"The intervention groups (100%, N = 10) that made significant use of the JITI app demonstrated improved performance for medication administration over the control group.",['38 teams having 2 to 3 senior nursing students on each team'],[],"['occurrence of MAEs', 'success rate', 'performance for medication administration']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}]",[],"[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0286540', 'cui_str': 'MAV protocol'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}]",,0.0246138,"The intervention groups (100%, N = 10) that made significant use of the JITI app demonstrated improved performance for medication administration over the control group.","[{'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Berg', 'Affiliation': 'From the College of Nursing (T.A.B., S.H.H., D.C., S.N.), and Office of Information Technology (C.S.), University of Tennessee, Knoxville, TN.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Hebert', 'Affiliation': ''}, {'ForeName': 'Deb', 'Initials': 'D', 'LastName': 'Chyka', 'Affiliation': ''}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Nidiffer', 'Affiliation': ''}, {'ForeName': 'Cary', 'Initials': 'C', 'LastName': 'Springer', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000529']
2621,33277203,The effect of music and skin contact with the newborn on pain and anxiety during episiotomy repair in primiparous women: A double-blind randomized controlled study.,"OBJECTIVE
To show that music medicine and skin contact with the newborns can reduce pain and anxiety during episiotomy repair.
DESIGN
Double-blind randomized controlled trial SETTING: The study was conducted between April and July 2020 at the private Medipol Nisa Hospital.
PARTICIPANTS
A total of 150 primiparous pregnant women over 20 years of age who underwent vaginal delivery with episiotomy INTERVENTIONS: Participants were randomized into the music medicine, skin contact with the newborn, and control groups (with no treatment). After episiotomy repair (with the designated treatment or no treatment), the State Trait Anxiety Inventory and Visual Analog Scale were used to assess anxiety and pain, respectively.
MAIN OUTCOME MEASURES
Pain and anxiety experienced after episiotomy repair in the treatment and control groups.
RESULTS
Women in both treatment groups (music medicine and skin-to-skin contact) had significantly lower anxiety and pain levels than those in the control group. In particular, music medicine significantly reduced pain in comparison to skin contact with the newborn (VAS 2 3.92 ± 1.46 vs. 5.42 ± 1.73, respectively, VAS 3 2.64 ± 1.63 vs. 5.14 ± 1.77, respectively, VAS 4 1.38 ± 1.46 vs. 4.14 ± 2.04, respectively, p < 0.05). Thus, music medicine is more effective than skin-to-skin contact in reducing the pain experienced during episiotomy repair, but both treatments were equally effective in reducing anxiety (35.30 ± 6.47 vs. 36.82 ± 9.71 vs. 49.22 ± 16.95, respectively, p < 0.05).
CONCLUSION
Both of these nonpharmacological treatments can be used along with analgesics and anxiolytics for the treatment of pain and anxiety during episiotomy repair.",2020,"RESULTS
Women in both treatment groups (music medicine and skin-to-skin contact) had significantly lower anxiety and pain levels than those in the control group.","['primiparous women', '150 primiparous pregnant women over 20 years of age who underwent vaginal delivery with episiotomy', 'April and July 2020 at the private Medipol Nisa Hospital']","['music medicine, skin contact with the newborn, and control groups (with no treatment', 'music and skin contact with the newborn']","['anxiety and pain levels', 'Pain and anxiety experienced after episiotomy repair', 'State Trait Anxiety Inventory and Visual Analog Scale', 'pain', 'pain and anxiety']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}, {'cui': 'C0014586', 'cui_str': 'Episiotomy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0014585', 'cui_str': 'Repair of episiotomy'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",150.0,0.0826557,"RESULTS
Women in both treatment groups (music medicine and skin-to-skin contact) had significantly lower anxiety and pain levels than those in the control group.","[{'ForeName': 'Ayça', 'Initials': 'A', 'LastName': 'Şolt Kırca', 'Affiliation': 'Kirklareli University School of Health, Midwifery Depertmant Kirklareli, Turkey. Electronic address: aycasolt@hotmail.com.'}, {'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kanza Gül', 'Affiliation': 'Medipol University School of Medicine Health, Istanbul, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.11.007']
2622,33277168,Lanolin and prenatal health education for prevention of nipple pain and trauma: Randomized clinical trial.,"OBJECTIVE
To investigate the effect of lanolin on nipple pain and trauma in breastfeeding after application of a health education.
METHOD
Randomized controlled clinical trial, with two arms, open, with 66 participants during prenatal care in the primary health care network in Goiania - Goias, Brazil. Participants were randomized (1:1) using computer generated numbers in both experimental group (EG) and control group (CG). The EG received lanolin and health education on breastfeeding at two different times with clinical demonstration using cloth didactic breast and illustrative album as the intervention, while the CG received standard health education. Health education was carried out by the same researchers in both groups. Measurement of pain, nipple trauma, and breastfeeding technique occurred on postpartum day eight. The analysis included descriptive statistics and inferential analysis by means chi-square or Fisher test, and Student's t-test, significance level set at 0.05.
RESULTS
A majority of the participants experienced no nipple trauma (59.1%) in both groups, and 60.6% of women experienced pain. In both groups, women showed favorable breastfeeding behaviors, except in the condition of the breasts. There were no significant differences between groups in pain prevention (p=0.61), nipple lesions (p=0.21), and breastfeeding technique (p>0.05).
CONCLUSION
It is not clear whether the intervention, lanolin combined with health education, has a positive effect on the prevention of nipple pain and trauma. Further research is needed to elucidate this question. Registration number: RBR-7tvhq8. Registry website: http://www.ensaiosclinicos.gov.br/.",2020,"There were no significant differences between groups in pain prevention (p=0.61), nipple lesions (p=0.21), and breastfeeding technique (p>0.05).
","['66 participants during prenatal care in the primary health care network in Goiania - Goias, Brazil']","['Lanolin and prenatal health education', 'computer generated numbers in both experimental group (EG) and control group (CG', 'lanolin']","['nipple trauma', 'pain prevention', 'favorable breastfeeding behaviors', 'Measurement of pain, nipple trauma, and breastfeeding technique', 'nipple lesions', 'pain']","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0023024', 'cui_str': 'Lanolin'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0028109', 'cui_str': 'Nipple structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1319304', 'cui_str': 'Breastfeeding performance'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",,0.075813,"There were no significant differences between groups in pain prevention (p=0.61), nipple lesions (p=0.21), and breastfeeding technique (p>0.05).
","[{'ForeName': 'Flávia Silva', 'Initials': 'FS', 'LastName': 'Oliveira', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brazil.'}, {'ForeName': 'Flaviana', 'Initials': 'F', 'LastName': 'Vieira', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brazil. Electronic address: flavianavieira@ufg.br.'}, {'ForeName': 'Janaína Valadares', 'Initials': 'JV', 'LastName': 'Guimarães', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brazil.'}, {'ForeName': ""Natalia Del'Angelo"", 'Initials': 'ND', 'LastName': 'Aredes', 'Affiliation': 'Faculty of Nursing, Federal University of Goias, Goiania, Goias, Brazil.'}, {'ForeName': 'Suzanne Hetzel', 'Initials': 'SH', 'LastName': 'Campbell', 'Affiliation': 'School of Nursing, University of British Columbia, Vancouver Campus, Canada.'}]",Enfermeria clinica,['10.1016/j.enfcli.2020.10.030']
2623,33277162,Pre-operative carbohydrate loading prior to elective caesarean delivery: a randomised controlled trial.,"INTRODUCTION
Women undergoing elective caesarean deliveries are fasted for long periods prior to surgery and can become catabolic. The use of pre-operative carbohydrate drinks to optimise patients ahead of major surgery is now well established. However, evidence to support this in women undergoing elective caesarean delivery is limited.
METHODS
We conducted a single-blind randomised control trial to study the effect of carbohydrate preloading on the presence of urinary ketones in mothers undergoing elective caesarean deliveries compared with standard care, fasting from midnight the night before surgery with free clear fluids until two hours prior to surgery.
RESULTS
Two-hundred and nine patients were allocated to either standard care (n=104) or pre-operative carbohydrate drinks (n=105) prior to elective caesarean section. Twenty-five were excluded from the analysis, leaving 184 (n=90; n=94). The incidence of urinary ketones immediately prior to surgery was lower in the carbohydrate group, 18.1% compared to 61.1% in the standard care group (P<0.001). Relative risk (95% CI) 3.33 (2.12-5.26), with a number needed-to-treat of three to prevent urinary ketosis in one woman. There were no major adverse events.
CONCLUSION
The results of this study support the introduction of carbohydrate drinks ahead of caesarean delivery to offset the effects of pre-operative fasting. However, the results may not be generalisable to all maternity units due to differences in fasting protocols.",2020,"The incidence of urinary ketones immediately prior to surgery was lower in the carbohydrate group, 18.1% compared to 61.1% in the standard care group (P<0.001).","['Two-hundred and nine patients', 'mothers undergoing elective caesarean deliveries compared with standard care, fasting from midnight the night before surgery with free clear fluids until two hours prior to surgery', 'Twenty-five were excluded from the analysis, leaving 184 (n=90; n=94', 'Women undergoing elective caesarean deliveries', 'women undergoing elective caesarean delivery']","['standard care (n=104) or pre-operative carbohydrate drinks (n=105) prior to elective caesarean section', 'Pre-operative carbohydrate loading prior to elective caesarean delivery', 'carbohydrate preloading']","['urinary ketosis', 'incidence of urinary ketones immediately prior to surgery', 'urinary ketones']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332172', 'cui_str': 'Midnight'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0453847', 'cui_str': 'Clear fluid'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0022634', 'cui_str': 'Ketone'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",209.0,0.0463668,"The incidence of urinary ketones immediately prior to surgery was lower in the carbohydrate group, 18.1% compared to 61.1% in the standard care group (P<0.001).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK. Electronic address: andrewclark7@nhs.net.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Litchfield', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hannah', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Love', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Slade', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lake', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Agaram', 'Affiliation': 'Glasgow Royal Infirmary, Glasgow, UK.'}]",International journal of obstetric anesthesia,['10.1016/j.ijoa.2020.10.008']
2624,33277091,A study comparing the effect of premedication with intravenous midazolam or dexmedetomidine on ketamine-fentanyl sedoanalgesia in burn patients: A randomized clinical trial.,"INTRODUCTION
Dressing changes and wound care-debridement procedures often cause fear and anxiety in burn patients, as these processes are quite painful. In order to determine the best method for alleviating pain during these procedures, the current study compared the efficacy and safety of intravenous dexmedetomidine and midazolam for premedication prior to these painful burn care procedures.
METHODS
This comparative and randomized study included patients who had a burn size of 1563%, were aged 1870 years, were diagnosed with the American Society of Anesthesiologists physical status (ASA I-II), and who underwent painful burn care procedures. Patients were intravenously administered either 1 mcg/kg dexmedetomidine (Group 1) or 0.03 mg/kg midazolam (Group 2) prior to the burn care procedure. Recorded at predetermined time points for each patient were heart rhythm (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO 2) , standard bispectral index (BIS), and Ramsay Sedation Scale (RSS).
RESULTS
In the dexmedetomidine group, HR and MAP measurements of patients at the 3rd, 5th, and 10th mins during sedation were significantly lower than the baseline values (p < 0.05). A significant decrease in SpO2 was observed in both groups at the 10th min during sedation, but the decline was higher in the midazolam group (p < 0.05). BIS measurements of the patients in both groups were significantly lower at 10 min. during sedation and at 15th and 60th mins during the procedure (p < 0.05). However, there was no significant difference between the group (p > 0.05). The RSS scales of both groups in during the sedation were higher in the 3rd, 5th and 10th mins than the baseline values (p < 0.05), but there was no significant difference between the groups (p > 0.05). The RSS scales of groups in during the burn procedure were significantly higher at 15 th min than the 0 th values, while the RSS scales of both groups were significantly lower in the 45th and 60th mins (p < 0.05).
CONCLUSION
Results of this study indicate that dexmedetomidine causes hemodynamic alterations while midazolam causes respiratory depression. However, these effects are not severe, and we conclude that both agents are safe and effective to ensure sedation prior to painful burn-care procedures.",2020,"The RSS scales of both groups in during the sedation were higher in the 3rd, 5th and 10th mins than the baseline values (p < 0.05), but there was no significant difference between the groups (p > 0.05).","['burn patients', 'patients who had a burn size of 1563%, were aged 1870 years, were diagnosed with the American Society of Anesthesiologists physical status (ASA I-II), and who underwent painful burn care procedures']","['ketamine-fentanyl sedoanalgesia', 'dexmedetomidine', 'midazolam', 'dexmedetomidine and midazolam']","['RSS scales', 'BIS measurements', 'HR and MAP measurements', 'efficacy and safety', 'heart rhythm (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO 2) , standard bispectral index (BIS), and Ramsay Sedation Scale (RSS', 'SpO2']","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1276417', 'cui_str': 'Burn care'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]",,0.0251211,"The RSS scales of both groups in during the sedation were higher in the 3rd, 5th and 10th mins than the baseline values (p < 0.05), but there was no significant difference between the groups (p > 0.05).","[{'ForeName': 'Muzaffer', 'Initials': 'M', 'LastName': 'Gencer', 'Affiliation': 'Department of Anesthesia, Istinye University Medical Faculty, Istanbul, Turkey. Electronic address: muzaffer.gencer@isu.edu.tr.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Sezen', 'Affiliation': 'Department of Anesthesia, Dr. Lutfi Kirdar Research and Education Hospital, Istanbul, Turkey. Electronic address: drozlemsezen@hotmail.com.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.05.027']
2625,33277086,Did lidocaine indeed significantly contribute to the reduction of opioid consumption in the treatment of background pain after burns in this randomized controlled trial?,,2020,,[],['lidocaine'],['opioid consumption'],[],"[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0455279,,"[{'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Itagaki', 'Affiliation': 'Emergency and Critical Care Center, Sapporo City General Hospital, Nishi13, Kita 11, Chu-o-ku, Sapporo, Hokkaido 060-8604, Japan. Electronic address: koaraninaritaizo@gmail.com.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Shiroshita', 'Affiliation': 'Department of Respiratory Medicine, Ichinomiyanishi Hospital Kaimeihira, Ichinomiya, Aichi 494-0001, Japan; Systematic Review Workshop Peer Support Group (SRWS-PSG), Chuo-ku, Osaka 541-0043, Japan. Electronic address: akihirokun8@gmail.com.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Banno', 'Affiliation': 'Systematic Review Workshop Peer Support Group (SRWS-PSG), Chuo-ku, Osaka 541-0043, Japan; Department of Psychiatry, Seichiryo Hospital, Tsurumai 4-16-27, Showa-ku, Nagoya 466-0064, Japan; Department of Psychiatry, Nagoya University Graduate School of Medicine, Tsurumai-cho 65, Showa-ku, Nagoya 466-8560, Japan. Electronic address: solvency@med.nagoya-u.ac.jp.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2020.05.030']
2626,33276816,Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes.,"BACKGROUND
Policy-makers are increasingly seeking rigorous evidence on the impact of programs that go beyond typical health care settings to improve outcomes for low-income families during the critical period around the transition to parenthood and through early childhood.
METHODS
This study is a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's expansion in South Carolina. The scientific trial was made possible by a ""Pay for Success"" program embedded within a 1915(b) Waiver from Medicaid secured by the South Carolina Department of Health and Human Services. This protocol describes study procedures and defines primary and secondary health-related outcomes that can be observed during the intervention period (including pregnancy through the child's first 2 years of life). Primary study outcomes include (1) a composite indicator for adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500 g), preterm birth (less than 37 weeks' gestation), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life), (2) a composite outcome indicating health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child's first 24 months of life, and (3) an indicator for an inter-birth interval of < 21 months. Secondary outcomes are defined similarly in three domains: (1) improving pregnancy and birth outcomes, (2) improving child health and development, and (3) altering the maternal life course through changes in family planning.
DISCUSSION
Evidence from this trial on the impact of home visiting services delivered at scale as part of a Medicaid benefit can provide policy-makers and stakeholders with crucial information about the effectiveness of home visiting programs in improving health and well-being for low-income mothers and children and about novel financing mechanisms for cross-silo interventions.
TRIAL REGISTRATION
The trial was registered prospectively on the American Economic Association Trial Registry (the primary registry for academic economists doing policy trials) on 16 February 2016 ( AEARCTR-0001039 ). ClinicalTrials.gov NCT03360539 . Registered on 28 November 2017.",2020,"Primary study outcomes include (1) a composite indicator for adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500 g), preterm birth (less than 37 weeks' gestation), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life), (2) a composite outcome indicating health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child's first 24 months of life, and (3) an indicator for an inter-birth interval of < 21 months.","[""Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes"", ""Nurse-Family Partnership's expansion in South Carolina""]",[],"[""health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child's first 24\u2009months of life, and (3) an indicator for an inter-birth interval"", 'three domains: (1) improving pregnancy and birth outcomes, (2) improving child health and development, and (3) altering the maternal life course through changes in family planning', ""adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500\u2009g), preterm birth (less than 37\u2009weeks' gestation), or perinatal mortality (fetal death at or after 20\u2009weeks of gestation or mortality""]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0005605', 'cui_str': 'Birth Spacing'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0015927', 'cui_str': 'Fetal death'}]",,0.119555,"Primary study outcomes include (1) a composite indicator for adverse birth outcomes including being born small for gestational age, low birth weight (less than 2500 g), preterm birth (less than 37 weeks' gestation), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life), (2) a composite outcome indicating health care utilization or mortality associated with major injury or concern for abuse or neglect occurring during the child's first 24 months of life, and (3) an indicator for an inter-birth interval of < 21 months.","[{'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'McConnell', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, 665 Huntington Avenue, Boston, MA, 02115, USA. mmcconne@hsph.harvard.edu.'}, {'ForeName': 'R Annetta', 'Initials': 'RA', 'LastName': 'Zhou', 'Affiliation': 'National Bureau of Economic Research (NBER), 1050 Massachusetts Avenue, Cambridge, MA, 02138, USA.'}, {'ForeName': 'Michelle W', 'Initials': 'MW', 'LastName': 'Martin', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, 677 Huntington Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Gourevitch', 'Affiliation': 'Department of Health Care Policy, Harvard Medical School, 108 Longwood Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Steenland', 'Affiliation': 'Population Studies and Training Center, Brown University, Box 1836, 68 Waterman Street, Providence, RI, 02912, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Bates', 'Affiliation': 'Abdul Latif Jameel Poverty Action Lab (J-PAL), Massachusetts Institute of Technology, 400 Main Street, E19-201, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Zera', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hacker', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School, 260 Longwood Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Alyna', 'Initials': 'A', 'LastName': 'Chien', 'Affiliation': 'Department of Pediatrics, Harvard Medical School, 260 Longwood Avenue, Boston, MA, 02115, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Baicker', 'Affiliation': 'National Bureau of Economic Research (NBER), 1050 Massachusetts Avenue, Cambridge, MA, 02138, USA.'}]",Trials,['10.1186/s13063-020-04916-9']
2627,33273055,Tobacco 21 adoption decreased sales of cigarette brands purchased by young people: a translation of population health survey data to gain insight into market data for policy analysis.,"INTRODUCTION
Policies raising the minimum age of sale of tobacco products to 21 (T21) proliferated at state and local levels across the USA before a federal policy was adopted. Evidence of the effectiveness of these policies is building and lags implementation. This study exploits demographic patterns of cigarette brand purchasing to evaluate the effectiveness of T21.
METHODS
To capture the effect of T21 implementation on cigarette sales, we used universal product code-level data from Nielsen Scantrack data covering January 2015 to October 2019. We used the 2015 to 2018 National Survey on Drug Use and Health to identify cigarette brands where smokers under 21 comprised a disproportionately high (young) and low (old) share of consumption. We fit fixed-effects linear regressions in Nielsen designated market areas to test if sales of young or old cigarette brands were changed by T21. Unadjusted models controlled for time and T21 implementation date. Adjusted models controlled for price, seasonality and unemployment. A permutation test of 5000 randomised placebo T21 policies were fit to determine how well the true date of implementation fit sales data stratified by brand group.
RESULTS
Sales of disproportionately young brands declined after T21 implementation. T21 policy implementation dates fit disproportionately young brand sales trends better than 99% of adjusted randomised placebo models. T21 implementation fit disproportionately old brand sales trends better than just 1% of adjusted randomised placebo models.
CONCLUSION
This study adds compelling empirical evidence that T21 decreased purchases of the cigarette brands consumed disproportionately by young people, the policy's target demographic.",2020,"This study adds compelling empirical evidence that T21 decreased purchases of the cigarette brands consumed disproportionately by young people, the policy's target demographic.",['2015 to 2018 National Survey on Drug Use and Health to identify cigarette brands where smokers under 21 comprised a disproportionately high (young) and low (old) share of consumption'],['T21 implementation'],[],"[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",[],[],,0.0520688,"This study adds compelling empirical evidence that T21 decreased purchases of the cigarette brands consumed disproportionately by young people, the policy's target demographic.","[{'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Liber', 'Affiliation': 'Cancer Prevention and Control, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, District of Columbia, USA alex.liber@georgetown.edu.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Xue', 'Affiliation': 'Economic and Health Policy Research, American Cancer Society, Atlanta, Georgia, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Cahn', 'Affiliation': 'Economic and Health Policy Research, American Cancer Society, Atlanta, Georgia, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Drope', 'Affiliation': 'Health Policy and Administration, University of Illinois Chicago School of Public Health, Chicago, Illinois, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Stoklosa', 'Affiliation': 'Health Policy and Administration, University of Illinois Chicago School of Public Health, Chicago, Illinois, USA.'}]",Tobacco control,['10.1136/tobaccocontrol-2020-055932']
2628,33273042,Durability of Triple Combination Therapy Versus Stepwise Addition Therapy in Patients With New-Onset T2DM: 3-Year Follow-up of EDICT.,"OBJECTIVE
To compare the long-term efficacy of initiating therapy with metformin/pioglitazone/exenatide in patients with new-onset type 2 diabetes mellitus (T2DM) versus sequential addition of metformin followed by glipizide and insulin.
RESEARCH DESIGN AND METHODS
Drug-naïve patients ( N = 318) with new-onset T2DM were randomly assigned to receive for 3 years either 1 ) combination therapy with metformin, pioglitazone, and exenatide (triple therapy) or 2 ) sequential addition of metformin followed by glipizide and insulin (conventional therapy) to maintain HbA 1c at <6.5% (48 mmol/mol). Insulin sensitivity and β-cell function were measured at baseline and 3 years. The primary outcome was the difference in HbA 1c between the groups at 3 years.
RESULTS
Baseline HbA 1c ± SEM values were 9.0% ± 0.2% and 8.9% ± 0.2% in the triple therapy and conventional therapy groups, respectively. The decrease in HbA 1c resulting from triple therapy was greater at 6 months than that produced by conventional therapy (0.30% [95% CI 0.21-0.39]; P = 0.001), and the HbA 1c reduction was maintained at 3 years in patients receiving triple therapy compared with conventional therapy (6.4% ± 0.1% and 6.9% ± 0.1%, respectively), despite intensification of antihyperglycemic therapy in the latter. Thus, the difference in HbA 1c between the two treatment groups at 3 years was 0.50% (95% CI 0.39-0.61; P < 0.0001). Triple therapy produced a threefold increase in insulin sensitivity and 30-fold increase in β-cell function. In conventional therapy, insulin sensitivity did not change and β-cell function increased by only 34% (both P < 0.0001 vs. triple therapy).
CONCLUSIONS
Triple therapy with agents that improve insulin sensitivity and β-cell function in patients with new-onset T2DM produce greater, more durable HbA 1c reduction than agents that lower glucose levels without correcting the underlying metabolic defects.",2020,"In conventional therapy, insulin sensitivity did not change and β-cell function increased by only 34% (both P < 0.0001 vs. triple therapy).
","['Drug-naïve patients ( N = 318) with new-onset T2DM', 'Patients With New-Onset T2DM', 'patients with new-onset type 2 diabetes mellitus (T2DM']","['metformin/pioglitazone/exenatide', 'Triple Combination Therapy Versus Stepwise Addition Therapy', 'metformin followed by glipizide and insulin', '1 ) combination therapy with metformin, pioglitazone, and exenatide (triple therapy) or 2 ) sequential addition of metformin followed by glipizide and insulin (conventional therapy) to maintain HbA 1c']","['β-cell function', 'insulin sensitivity and β-cell function', 'decrease in HbA 1c resulting from triple therapy', 'Baseline HbA 1c ± SEM values', 'Insulin sensitivity and β-cell function', 'insulin sensitivity', 'HbA 1c']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C1635037', 'cui_str': 'metformin and pioglitazone'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0017642', 'cui_str': 'Glipizide'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]","[{'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",318.0,0.0277304,"In conventional therapy, insulin sensitivity did not change and β-cell function increased by only 34% (both P < 0.0001 vs. triple therapy).
","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX.'}, {'ForeName': 'Curtiss', 'Initials': 'C', 'LastName': 'Puckett', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khattab', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX.'}, {'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Baskoy', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX.'}, {'ForeName': 'Ralph A', 'Initials': 'RA', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center and Texas Diabetes Institute, San Antonio, TX defronzo@uthscsa.edu.'}]",Diabetes care,['10.2337/dc20-0978']
2629,33272980,A Randomized Phase IIb Study of Low-dose Tamoxifen in Chest-irradiated Cancer Survivors at risk for Breast Cancer.,"PURPOSE
Low-dose tamoxifen reduces breast cancer risk, but remains untested in chest-irradiated cancer survivors - a population with breast cancer risk comparable to BRCA mutation carriers. We hypothesized that low-dose tamoxifen would be safe and efficacious in reducing radiation-related breast cancer risk.
EXPERIMENTAL DESIGN
We conducted an investigator-initiated, randomized, phase IIb, double-blinded, placebo-controlled trial (FDA IND107367) between 2010 and 2016 at 15 US sites. Eligibility included ≥12Gy of chest radiation by age 40y and age at enrollment ≥25y. Patients were randomized 1:1 to low-dose tamoxifen (5mg/day) or identical placebo tablets for 2y. The primary endpoint was mammographic dense area at baseline, 1y and 2y. Insulin growth factor-1 (IGF-1) plays a role in breast carcinogenesis; circulating IGF-1 and IGF-BP3 levels at baseline, 1y and 2y served as secondary endpoints.
RESULTS
Seventy-two participants (low-dose tamoxifen: n=34, placebo: n=38) enrolled at a median age of 43.8y (35-49) were evaluable. They had received chest radiation at a median dose of 30.3 Gy. Compared with the placebo arm, the low-dose tamoxifen arm participants had significantly lower mammographic dense area ( P =0.02) and IGF1 levels ( P <0.0001), and higher IGFBP-3 levels ( P =0.02). There was no difference in toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and anti-thrombin III; urine N-telopeptide crosslinks) between the treatment arms. We did not identify any grade 3-4 adverse events related to low-dose tamoxifen.
CONCLUSIONS
In this randomized trial in chest-irradiated cancer survivors, we find that low-dose tamoxifen is effective in reducing established biomarkers of breast cancer risk and could serve as a risk-reduction strategy.",2020,"There was no difference in toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and anti-thrombin III; urine N-telopeptide crosslinks) between the treatment arms.","['Chest-irradiated Cancer Survivors at risk for Breast Cancer', '2010 and 2016 at 15 US sites', 'chest-irradiated cancer survivors', 'Eligibility included ≥12Gy of chest radiation by age 40y and age at enrollment ≥25y', 'n=38) enrolled at a median age of 43.8y (35-49) were evaluable']","['placebo', 'Low-dose Tamoxifen', 'tamoxifen', 'placebo tablets']","['toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and anti-thrombin III; urine N-telopeptide crosslinks', 'higher IGFBP-3 levels', 'IGF1 levels', 'mammographic dense area']","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0312399', 'cui_str': 'Alkaline phosphatase isoenzyme, bone fraction'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1096172', 'cui_str': 'N-telopeptide urine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202220', 'cui_str': 'Somatomedin-C measurement'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.341647,"There was no difference in toxicity biomarkers (serum bone-specific alkaline phosphatase, lipids, and anti-thrombin III; urine N-telopeptide crosslinks) between the treatment arms.","[{'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship and Division of Pediatric Hematology-Oncology, University of Alabama at Birmingham sbhatia@peds.uab.edu.'}, {'ForeName': 'Melanie R', 'Initials': 'MR', 'LastName': 'Palomares', 'Affiliation': 'Clinical Care and Outreach, Cancer Prevention Movement.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Hageman', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship and Division of Pediatric Hematology-Oncology, University of Alabama at Birmingham.'}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship and Division of Pediatric Hematology-Oncology, University of Alabama at Birmingham.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Landier', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship and Division of Pediatric Hematology-Oncology, University of Alabama at Birmingham.'}, {'ForeName': 'Kandice', 'Initials': 'K', 'LastName': 'Adams', 'Affiliation': 'Institute for Cancer Outcomes and Survivorship and Division of Pediatric Hematology-Oncology, University of Alabama at Birmingham.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Umphrey', 'Affiliation': 'Breast Imaging, MidSouth Imaging.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Reich', 'Affiliation': 'Radiology, University of Alabama at Birmingham.'}, {'ForeName': 'Kathryn W', 'Initials': 'KW', 'LastName': 'Zamora', 'Affiliation': 'Radiology, University of Alabama at Birmingham.'}, {'ForeName': 'Saro H', 'Initials': 'SH', 'LastName': 'Armenian', 'Affiliation': 'Population Sciences, City of Hope.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Division of Cancer Prevention and Population Science, University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Blaes', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of Minnesota.'}, {'ForeName': 'Tara O', 'Initials': 'TO', 'LastName': 'Henderson', 'Affiliation': 'Pediatrics, University of Chicago.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Hodgson', 'Affiliation': 'Radiation Medicine Programme, University of Toronto, Princess Margaret Cancer Centre.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Oncology, St. Jude Children's Research Hospital.""}, {'ForeName': 'Larissa A', 'Initials': 'LA', 'LastName': 'Korde', 'Affiliation': 'Cancer Therapy Evaluation Program, National Cancer Institute.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Melin', 'Affiliation': 'Hematology and Oncology, Comprehensive Cancer Center of Wake Forest University.'}, {'ForeName': 'Sofia Diana', 'Initials': 'SD', 'LastName': 'Merajver', 'Affiliation': 'Internal Medicine, University of Michigan-Ann Arbor.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Overholser', 'Affiliation': 'University of Colorado Boulder.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Pruthi', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic.'}, {'ForeName': 'F Lennie', 'Initials': 'FL', 'LastName': 'Wong', 'Affiliation': 'Population Sciences, City of Hope Cancer Center.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-3609']
2630,33272965,"Ziltivekimab for Treatment of Anemia of Inflammation in Patients on Hemodialysis: Results from a Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.","BACKGROUND
Patients with CKD who are on hemodialysis are hyporesponsive to erythropoiesis-stimulating agents (ESAs) because of anemia of inflammation. Interleukin-6 (IL-6) induced hepcidin expression is a key mediator of such inflammation.
METHODS
This phase 1/2, placebo-controlled trial assessed effects of ziltivekimab, a novel anti-IL-6 ligand antibody, in patients on hemodialysis with rs855791, a single nucleotide polymorphism of the TMPRSS6 gene that is hypothesized to heighten susceptibility to IL-6-mediated inflammatory effects. After a screening period documenting stable ESA and iron dosing, we randomized 61 patients with elevated IL-6 (≥4 pg/ml) to receive placebo or ziltivekimab (doses of 2, 6, or 20 mg), administered intravenously every 2 weeks for 12 weeks during hemodialysis. ESA dose adjustments were allowed after 4 weeks. We analyzed safety and effects on inflammation, iron metabolism, serum albumin, and anti-drug antibodies.
RESULTS
No patient experienced dose-limiting toxicity. Four patients (two each in the 6- and 20-mg cohorts) died of a treatment-emergent adverse event. Compared with patients receiving placebo, those receiving ziltivekimab experienced significantly greater reductions of high-sensitivity C-reactive protein, serum amyloid A, and fibrinogen from baseline to end of treatment. Median ESA usage decreased by 15,000, 15,000, or 33,000 IU/wk per patient in the 2-, 6-, and 20-mg ziltivekimab cohorts, respectively, compared with no change in the placebo group. We also noted significant dose responses for decreased ESA resistance index and increased serum iron, total iron binding capacity, transferrin saturation, and serum albumin.
CONCLUSIONS
Ziltivekimab significantly improved markers of inflammation, reduced ESA requirements, and increased serum albumin in patients on hemodialysis with inflammation and hyporesponsiveness to ESA therapy.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of COR-001, NCT02868229.",2020,"We also noted significant dose responses for decreased ESA resistance index and increased serum iron, total iron binding capacity, transferrin saturation, and serum albumin.
","['61 patients with elevated IL-6', 'Patients with CKD who are on hemodialysis are hyporesponsive to erythropoiesis-stimulating agents (ESAs) because of anemia of inflammation', 'patients on hemodialysis with rs855791', 'Patients on Hemodialysis']","['ziltivekimab', 'placebo', 'Ziltivekimab', 'placebo or ziltivekimab', 'Placebo']","['Anemia of Inflammation', 'dose-limiting toxicity', 'Median ESA usage', 'high-sensitivity C-reactive protein, serum amyloid A, and fibrinogen', 'ESA resistance index and increased serum iron, total iron binding capacity, transferrin saturation, and serum albumin', 'inflammation, iron metabolism, serum albumin, and anti-drug antibodies', 'markers of inflammation, reduced ESA requirements', 'serum albumin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0014819', 'cui_str': 'Erythrocyte production'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0151900', 'cui_str': 'Serum iron raised'}, {'cui': 'C0700379', 'cui_str': 'Total iron binding capacity'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",61.0,0.432208,"We also noted significant dose responses for decreased ESA resistance index and increased serum iron, total iron binding capacity, transferrin saturation, and serum albumin.
","[{'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Pergola', 'Affiliation': 'Renal Associates, P.A., San Antonio, Texas.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Devalaraja', 'Affiliation': 'Corvidia Therapeutics, Inc., Waltham, Massachusetts mdevalaraja@corvidiatx.com.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Fishbane', 'Affiliation': 'Division of Nephrology, Department of Medicine, Donald and Barbara Zucker School of Medicine, Great Neck, New York.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Renal Medicine Disease and Hypertension, University of Colorado, Aurora, Colorado.'}, {'ForeName': 'Vandana S', 'Initials': 'VS', 'LastName': 'Mathur', 'Affiliation': 'Mathur Consulting, Woodside, California.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Smith', 'Affiliation': 'Nephrology Associates, Augusta, Georgia.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Lo', 'Affiliation': 'Corvidia Therapeutics, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Herzog', 'Affiliation': 'Corvidia Therapeutics, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kakkar', 'Affiliation': 'Pandion Therapeutics, Inc., Waltham, Massachusetts.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Davidson', 'Affiliation': 'Corvidia Therapeutics, Inc., Waltham, Massachusetts.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020050595']
2631,33272841,Effects of a single bout of short-duration high-intensity and long-duration low-intensity exercise on insulin resistance and adiponectin/leptin ratio.,"OBJECTIVES
Moderate-intensity exercise improves insulin sensitivity, which may depend on the intensity, duration, and frequency of exercise. We examined the effects of a single bout of short-duration high-intensity exercise (HIE) and long-duration lowintensity exercise (LIE) on insulin sensitivity and the adiponectin/leptin ratio in individuals with different body mass indices (BMIs) who do not exercise regularly.
METHODS
We enrolled 42 healthy volunteers aged 20-64 years and divided them into two groups based on BMI: BMI <24 kg/m 2 and BMI ≥27 kg/m 2 . They were randomly assigned to either the short-duration (20 min) HIE (70%-80% heart rate reserve, HRR) or long-duration (60 min) LIE training groups (30%-40% HRR). Glucose, insulin, adiponectin, and leptin levels were assessed before training and at 0, 30, 60, and 120 min after training.
RESULTS
We finally analyzed 27 normal weight and 9 obese individuals. No significant differences were observed in the baseline information of both BMI groups. Homeostatic model assessment for insulin resistance significantly improved for both exercise patterns in the normal weight group and for the HIE pattern in the obese group (P < 0.01), whereas the adiponectin/leptin ratio increased significantly only among normal weight participants with the LIE intervention.
CONCLUSION
Both exercise patterns in BMI <24 kg/m 2 and BMI ≥27 kg/m 2 benefit on insulin resistance. Therefore, people can choose the way they can fit to improve insulin resistance both short-duration high-intensity exercise and long-duration low-intensity exercise.",2020,"Homeostatic model assessment for insulin resistance significantly improved for both exercise patterns in the normal weight group and for the HIE pattern in the obese group (P < 0.01), whereas the adiponectin/leptin ratio increased significantly only among normal weight participants with the LIE intervention.
","['individuals with different body mass indices (BMIs) who do not exercise regularly', '42 healthy volunteers aged 20-64 years and divided them into two groups based on BMI: BMI <24 kg/m 2 and BMI ≥27 kg/m 2 ', '27 normal weight and 9 obese individuals']","['single bout of short-duration high-intensity exercise (HIE) and long-duration lowintensity exercise (LIE', 'single bout of short-duration high-intensity and long-duration low-intensity exercise']","['insulin sensitivity and the adiponectin/leptin ratio', 'Homeostatic model assessment for insulin resistance', 'Glucose, insulin, adiponectin, and leptin levels', 'insulin resistance and adiponectin/leptin ratio', 'adiponectin/leptin ratio']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0556454', 'cui_str': 'Exercises regularly'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",42.0,0.0718396,"Homeostatic model assessment for insulin resistance significantly improved for both exercise patterns in the normal weight group and for the HIE pattern in the obese group (P < 0.01), whereas the adiponectin/leptin ratio increased significantly only among normal weight participants with the LIE intervention.
","[{'ForeName': 'Hsiang-Han', 'Initials': 'HH', 'LastName': 'Kao', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hua-Shui', 'Initials': 'HS', 'LastName': 'Hsu', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Tai-Hsien', 'Initials': 'TH', 'LastName': 'Wu', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hui-Fen', 'Initials': 'HF', 'LastName': 'Chiang', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ying', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition, College of Biopharmaceutical and Food Sciences, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Sports Medicine, College of Health Care, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Wen-Yuan', 'Initials': 'WY', 'LastName': 'Lin', 'Affiliation': 'Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan; Department of Family Medicine, College of Medicine, China Medical University, Taichung, Taiwan; Department of Social Medicine, College of Medicine, China Medical University, Taichung, Taiwan. Electronic address: wylin@mail.cmu.edu.tw.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.09.007']
2632,33272839,Quality of life in tongue cancer treated patients before and after speech therapy: a randomized clinical trial.,"INTRODUCTION
Tongue cancer is one of the most common subtypes of head and neck cancer. The aggressive effects of treatment cause aesthetic, psychosocial and functional deficits, especially dysphagia, which affects patient quality of life. Rehabilitation, which is essential for functional maximum recovery, helps patients deal with new and altered structures and has a positive impact on quality of life.
OBJECTIVE
To verify the impact of speech therapy on swallowing quality of life in tongue cancer patients after treatment.
METHODS
This parallel randomized clinical trial was conducted at a public hospital in Porto Alegre, RS, Brazil. Before and after the intervention, a quality of life questionnaire (the Deglutition Handicap Index) was employed, dysphagia severity was assessed with fiberoptic endoscopic evaluation of swallowing, and the Functional Oral Intake Scale carried out. The experimental group underwent four-week sessions of speech therapy over one month, while the control group received the institution's usual follow-up.
RESULTS
Thirty individuals treated for tongue cancer were divided into a study and a control group. Deglutition Handicap Index scores decreased significantly (approximately 40 points) (p < 0.001) after the intervention in the study group. There was a significant correlation between improved quality of life, reduced dysphagia severity and increased in Functional Oral Intake Scale scores (p < 0.001).
CONCLUSION
After speech therapy, quality of life scores related to deglutition and dysphagia severity improved in patients treated for tongue cancer.",2020,"After speech therapy, quality of life scores related to deglutition and dysphagia severity improved in patients treated for tongue cancer.","['Thirty individuals treated for tongue cancer', 'public hospital in Porto Alegre, RS, Brazil', 'tongue cancer treated patients before and after speech therapy', 'tongue cancer patients after treatment']","[""institution's usual follow-up"", 'speech therapy']","['quality of life scores related to deglutition and dysphagia severity', 'swallowing quality of life', 'fiberoptic endoscopic evaluation of swallowing, and the Functional Oral Intake Scale', 'dysphagia severity', 'quality of life, reduced dysphagia severity', 'Deglutition Handicap Index scores', 'quality of life questionnaire (the Deglutition Handicap Index', 'Quality of life', 'Functional Oral Intake Scale scores']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0153349', 'cui_str': 'Malignant tumor of tongue'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]","[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009460', 'cui_str': 'Communication disorder'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0336595,"After speech therapy, quality of life scores related to deglutition and dysphagia severity improved in patients treated for tongue cancer.","[{'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Balbinot', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Medicina, Programa de Pós-Graduação em Medicina: Ciências Cirúrgicas, Porto Alegre, RS, Brazil. Electronic address: jor.balbinot@hotmail.com.'}, {'ForeName': 'Caroline Santana', 'Initials': 'CS', 'LastName': 'Real', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Medicina, Programa de Pós-Graduação em Medicina: Ciências Cirúrgicas, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Cecília Corte de', 'Initials': 'CC', 'LastName': 'Melo', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Odontologia, Departamento de Saúde e Comunicação Humana, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Dornelles', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Odontologia, Departamento de Saúde e Comunicação Humana, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Sady Selaimen da', 'Initials': 'SSD', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Faculdade de Medicina, Departamento de Oftalmologia e Otorrinolaringologia, Porto Alegre, RS, Brazil.'}]",Brazilian journal of otorhinolaryngology,['10.1016/j.bjorl.2020.10.005']
2633,33272766,Self-concept and Engagement in LiFe (SELF): A waitlist-controlled pilot study of a novel psychological intervention to target illness engulfment in enduring schizophrenia and related psychoses.,"BACKGROUND
Illness engulfment, a process whereby one's self-concept becomes defined entirely by illness, is implicated in the association between insight and depressive symptomatology in schizophrenia. We examined the feasibility and acceptability of a brief intervention called Self-concept and Engagement in LiFe (SELF) that aims to reduce engulfment and enhance personal recovery.
METHODS
Forty individuals diagnosed with schizophrenia spectrum disorders were assigned to SELF intervention or waitlist-control (treatment-as-usual). Outcome measures included the Modified Engulfment Scale and measures of depressive symptomatology, self-esteem, recovery style, quality of life, and self-stigma.
RESULTS
Retention at post-therapy was 90% (18/20 completed SELF; 18/20 remained on waitlist). Eleven waitlist participants then completed SELF (73% overall retention). Participants reported high satisfaction with the intervention, and participation was associated with reduced engulfment (ES = 0.48), more adaptive recovery style (ES = 0.37), improved self-esteem (ES = 0.35), and reduced self-stigma (ES = 0.25). The treatment group had lower engulfment (adjusted mean = 91.9) compared to waitlist (adjusted mean = 100.0) post-therapy, F (1,32) = 5.78, p = .02, partial η 2 = 0.15.
CONCLUSIONS
The SELF intervention is highly acceptable to participants and can reduce engulfment and improve secondary outcomes. Future research should examine the efficacy of SELF in a larger randomized controlled trial.",2020,"The treatment group had lower engulfment (adjusted mean = 91.9) compared to waitlist (adjusted mean = 100.0) post-therapy, F (1,32) = 5.78, p = .02, partial η 2 = 0.15.
","['LiFe (SELF', 'Forty individuals diagnosed with schizophrenia spectrum disorders', 'enduring schizophrenia and related psychoses']","['brief intervention called Self-concept and Engagement in LiFe (SELF', 'SELF intervention or waitlist-control (treatment-as-usual', 'novel psychological intervention', 'SELF intervention']","['adaptive recovery style', 'reduced self-stigma', 'Modified Engulfment Scale and measures of depressive symptomatology, self-esteem, recovery style, quality of life, and self-stigma', 'improved self-esteem']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",11.0,0.07171,"The treatment group had lower engulfment (adjusted mean = 91.9) compared to waitlist (adjusted mean = 100.0) post-therapy, F (1,32) = 5.78, p = .02, partial η 2 = 0.15.
","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Konsztowicz', 'Affiliation': 'Department of Psychology, McGill University, 2001 McGill College Ave, Montréal, QC H3A 1G1, Canada. Electronic address: sue.konsztowicz@mail.mcgill.ca.'}, {'ForeName': 'Casandra Roy', 'Initials': 'CR', 'LastName': 'Gelencser', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, 405 Rue Sainte-Catherine Est, Montréal, QC H2L 2C4, Canada. Electronic address: roy_gelencser.casandra@courrier.uqam.ca.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Otis', 'Affiliation': 'Douglas Mental Health University Institute, 6875 LaSalle Boulevard, Montreal, QC H4H 1R3, Canada. Electronic address: catherine.otis@douglas.mcgill.ca.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Douglas Mental Health University Institute, 6875 LaSalle Boulevard, Montreal, QC H4H 1R3, Canada; Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC H3A 1A1, Canada. Electronic address: norbert.schmitz@mcgill.ca.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lepage', 'Affiliation': 'Douglas Mental Health University Institute, 6875 LaSalle Boulevard, Montreal, QC H4H 1R3, Canada; Department of Psychiatry, McGill University, 1033 Pine Avenue West, Montreal, QC H3A 1A1, Canada. Electronic address: martin.lepage@mcgill.ca.'}]",Schizophrenia research,['10.1016/j.schres.2020.11.028']
2634,33272650,Long-Term Outcome of ABO-Incompatible Kidney Transplantation in Patients Treated With Low-Dose Rituximab Regimen.,"BACKGROUND
Introduction of rituximab in the desensitization protocols for ABO-incompatible (ABOI) kidney transplantation (KTX) has afforded excellent results. However, the acceptability of minimal dosage of rituximab in these protocols remains to be defined.
METHODS
Sixty-three patients who underwent ABOI KTX were included in this study. The desensitization protocol consisted of plasmapheresis, tacrolimus, mycophenolate mofetil, methylprednisolone, intravenous immunoglobulin, basiliximab, and low-dose rituximab (100 mg/body). We evaluated the efficacy, safety, and long-term outcome of this protocol (group R, n = 39) and compared them with those of patients who underwent splenectomy (group S, n = 24).
RESULTS
Graft and patient survival at 10 years after KTX were comparable between the groups (94.4% [group R] vs 95.4% [group S] and 94.6% [group R] vs 95.8% [group S], respectively). The incidence of acute antibody-mediated rejection (AAMR) was similar in the 2 groups (10.2% vs 12.5%). There were no significant differences in the incidence of chronic active antibody-mediated rejection. Of the patients, 7 developed AAMR and 3 of these patients (1 in group R and 2 in group S) lost their grafts. There were no significant differences in the incidence of chronic active antibody-mediated rejection. The incidence of postoperative cytomegalovirus infection in group R was significantly lower than that in group S. Furthermore, the incidence of postoperative late-onset neutropenia was low in group R.
CONCLUSIONS
A low-dose rituximab regimen for ABOI KTX is acceptable for preventing AAMR with a low incidence of delayed adverse events.",2020,"The incidence of postoperative cytomegalovirus infection in group R was significantly lower than that in group S. Furthermore, the incidence of postoperative late-onset neutropenia was low in group R.
","['Sixty-three patients who underwent ABOI KTX were included in this study', 'Patients Treated With Low-Dose Rituximab Regimen', 'ABO-incompatible (ABOI) kidney transplantation (KTX', 'group S, n\xa0= 24']","['splenectomy', 'rituximab', 'plasmapheresis, tacrolimus, mycophenolate mofetil, methylprednisolone, intravenous immunoglobulin, basiliximab, and low-dose rituximab', 'ABO-Incompatible Kidney Transplantation']","['Graft and patient survival', 'incidence of acute antibody-mediated rejection (AAMR', 'incidence of postoperative late-onset neutropenia', 'incidence of chronic active antibody-mediated rejection', 'incidence of postoperative cytomegalovirus infection', 'efficacy, safety']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0013184', 'cui_str': 'Drug Incompatibility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0441853', 'cui_str': 'Group S'}]","[{'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032134', 'cui_str': 'Plasmapheresis'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0013184', 'cui_str': 'Drug Incompatibility'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3805247', 'cui_str': 'Late onset neutropenia'}, {'cui': 'C0332212', 'cui_str': 'Chronic active'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",63.0,0.0218705,"The incidence of postoperative cytomegalovirus infection in group R was significantly lower than that in group S. Furthermore, the incidence of postoperative late-onset neutropenia was low in group R.
","[{'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Sasaki', 'Affiliation': 'Departments of Kidney Transplant Surgery, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Kiyohiko', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Urology, Hokkaido University Hospital, Sapporo, Japan. Electronic address: hotta1125@mac.com.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Mitsuke', 'Affiliation': 'Departments of Kidney Transplant Surgery, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Fukasawa', 'Affiliation': 'Department of Surgical Pathology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Tatsu', 'Initials': 'T', 'LastName': 'Tanabe', 'Affiliation': 'Department of Urology, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Higuchi', 'Affiliation': 'Departments of Kidney Transplant Surgery, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Takada', 'Affiliation': 'Department of Urology, Sapporo City General Hospital, Sapporo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Harada', 'Affiliation': 'Departments of Kidney Transplant Surgery, Sapporo City General Hospital, Sapporo, Japan.'}]",Transplantation proceedings,['10.1016/j.transproceed.2020.10.023']
2635,33272334,"Comparing audiometric parameters between crushed and intact cartilage tympanoplasty: a double-blinded, randomised, controlled trial study.","OBJECTIVE
To investigate hearing and the take rate of crushed cartilage grafts in tympanoplasty.
METHODS
In this double-blinded, randomised, controlled trial, 46 patients with tympanic membrane perforation were enrolled. A conchal cartilage graft was used for reconstruction in both intervention and control groups. In the intervention group, crushed cartilage was used. The success rate and hearing results were ascertained every four months over a one-year follow-up period.
RESULTS
A total of 36 patients - 20 in the intervention group and 16 in the control group - completed one year of follow up. There were no statistically significant differences between the two groups in mean air-bone gap, bone conduction threshold, speech discrimination score or speech reception threshold.
CONCLUSION
The reduction in living cells after crushed cartilage tympanoplasty may decrease the rigidity and the volume of the graft, but may not necessarily improve the hearing results.",2020,"There were no statistically significant differences between the two groups in mean air-bone gap, bone conduction threshold, speech discrimination score or speech reception threshold.
","['46 patients with tympanic membrane perforation were enrolled', '36 patients - 20 in the intervention group and 16 in the control group - completed one year of follow up']",['crushed and intact cartilage tympanoplasty'],"['success rate and hearing results', 'living cells', 'mean air-bone gap, bone conduction threshold, speech discrimination score or speech reception threshold']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206504', 'cui_str': 'Perforation of tympanic membrane'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0005935', 'cui_str': 'Bone conduction'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}]",46.0,0.0979043,"There were no statistically significant differences between the two groups in mean air-bone gap, bone conduction threshold, speech discrimination score or speech reception threshold.
","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tajdini', 'Affiliation': 'Department of Otorhinolaryngology, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hatami', 'Affiliation': 'Department of Otorhinolaryngology, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rahmaty', 'Affiliation': 'Department of Otorhinolaryngology, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kouhi', 'Affiliation': 'Department of Otorhinolaryngology, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dabiri', 'Affiliation': 'Department of Otorhinolaryngology, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Aghazadeh', 'Affiliation': 'Department of Otorhinolaryngology, Tehran University of Medical Sciences, Amir Alam Hospital, Tehran, Iran.'}]",The Journal of laryngology and otology,['10.1017/S0022215120002327']
2636,33272333,A randomized trial shows dose-frequency and genotype may determine the therapeutic efficacy of intranasal oxytocin.,"BACKGROUND
The neuropeptide oxytocin is proposed as a promising therapy for social dysfunction by modulating amygdala-mediated social-emotional behavior. Although clinical trials report some benefits of chronic treatment, it is unclear whether efficacy may be influenced by dose frequency or genotype.
METHODS
In a randomized, double-blind, placebo-controlled pharmaco-functional magnetic resonance imaging trial (150 male subjects), we investigated acute and different chronic (every day or on alternate days for 5 days) intranasal oxytocin (24 international units) effects and oxytocin receptor genotype-mediated treatment sensitivity on amygdala responses to face emotions. We also investigated similar effects on resting-state functional connectivity between the amygdala and prefrontal cortex.
RESULTS
A single dose of oxytocin-reduced amygdala responses to all face emotions but for threatening (fear and anger) and happy faces, this effect was abolished after daily doses for 5 days but maintained by doses given every other day. The latter dose regime also enhanced associated anxious-arousal attenuation for fear faces. Oxytocin effects on reducing amygdala responses to face emotions only occurred in AA homozygotes of rs53576 and A carriers of rs2254298. The effects of oxytocin on resting-state functional connectivity were not influenced by either dose-frequency or receptor genotype.
CONCLUSIONS
Infrequent chronic oxytocin administration may be therapeutically most efficient and its anxiolytic neural and behavioral actions are highly genotype-dependent in males.",2020,Oxytocin effects on reducing amygdala responses to face emotions only occurred in AA homozygotes of rs53576 and A carriers of rs2254298.,['150 male subjects'],"['placebo-controlled pharmaco-functional magnetic resonance imaging trial', 'neuropeptide oxytocin', 'intranasal oxytocin', 'oxytocin receptor genotype-mediated treatment sensitivity', 'oxytocin', 'Oxytocin']","['anxious-arousal attenuation for fear faces', 'resting-state functional connectivity', 'amygdala responses to face emotions']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0069841', 'cui_str': 'Oxytocin Receptor'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",150.0,0.334085,Oxytocin effects on reducing amygdala responses to face emotions only occurred in AA homozygotes of rs53576 and A carriers of rs2254298.,"[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Kou', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu611731, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu611731, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu611731, China.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Sindermann', 'Affiliation': 'Department of Molecular Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Montag', 'Affiliation': 'Department of Molecular Psychology, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu611731, China.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu611731, China.'}]",Psychological medicine,['10.1017/S0033291720003803']
2637,33272319,Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET).,"BACKGROUND
Patients with COVID-19 and hypoxaemia despite conventional low-flow oxygen therapy are often treated with high-flow nasal cannula (HFNC) in line with international guidelines. Oxygen delivery by helmet continuous positive airway pressure (CPAP) is a feasible option that enables a higher positive end-expiratory pressure (PEEP) and may theoretically reduce the need for intubation compared to HFNC but direct comparative evidence is lacking.
METHODS
We plan to perform an investigator-initiated, pragmatic, randomised trial at an intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden. We have estimated a required sample size of 120 patients randomised 1:1 to HFNC or Helmet CPAP to achieve 90% power to detect superiority at a 0.05 significance level regarding the primary outcome of ventilator free days (VFD) within 28 days using a Mann-Whitney U test. Patient recruitment is planned to being June 2020 and be completed in the first half of 2021.
DISCUSSION
We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival. This could have important implications during the current COVID-19 epidemic.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04395807 . Registered on 20 May 2020.",2020,We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival.,"['Patients with COVID-19 and hypoxaemia despite', 'intermediate-level COVID-19 cohort ward in Helsingborg Hospital, southern Sweden']","['Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19', 'HFNC or Helmet CPAP', 'Helmet CPAP', 'Oxygen delivery by helmet continuous positive airway pressure (CPAP', 'high-flow nasal cannula (HFNC', 'conventional low-flow oxygen therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]",[],,0.564328,We hypothesise that the use of Helmet CPAP will reduce the need for invasive mechanical ventilation compared to the use of HFNC without having a negative effect on survival.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Tverring', 'Affiliation': 'Lunds universitet Medicinska fakulteten, Lund, Sweden. jonas.tverring@med.lu.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Åkesson', 'Affiliation': 'Lunds universitet Medicinska fakulteten, Lund, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Lunds universitet Medicinska fakulteten, Lund, Sweden.'}]",Trials,['10.1186/s13063-020-04863-5']
2638,33272311,The effectiveness of battlefield acupuncture in addition to standard physical therapy treatment after shoulder surgery: a protocol for a randomized clinical trial.,"INTRODUCTION
There is a large incidence of shoulder instability among active young athletes and military personnel. Shoulder stabilization surgery is the commonly employed intervention for treating individuals with instability. Following surgery, a substantial proportion of individuals experience acute post-operative pain, which is usually managed with opioid pain medications. Unfortunately, the extended use of opioid medications can have adverse effects that impair function and reduce military operational readiness, but there are currently few alternatives. However, battlefield acupuncture (BFA) is a minimally invasive therapy demonstrating promise as a non-pharmaceutical intervention for managing acute post-operative pain.
METHODS
This is a parallel, two-arm, single-blind randomized clinical trial. The two independent variables are intervention (2 levels, standard physical therapy and standard physical therapy plus battlefield acupuncture) and time (5 levels, 24 h, 48 h, 72 h, 1 week, and 4 weeks post shoulder stabilization surgery). The primary dependent variables are worst and average pain as measured on the visual analog scale. Secondary outcomes include medication usage, Profile of Mood States, and Global Rating of Change.
DISCUSSION
The magnitude of the effect of BFA is uncertain; current studies report confidence intervals of between-group differences that include minimal clinically important differences between intervention and control groups. The results of this study may help determine if BFA is an effective adjunct to physical therapy in reducing pain and opioid usage in acute pain conditions.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04094246 . Registered on 16 September 2019.",2020,"The results of this study may help determine if BFA is an effective adjunct to physical therapy in reducing pain and opioid usage in acute pain conditions.
","['active young athletes and military personnel', 'after shoulder surgery', 'individuals with instability']","['standard physical therapy treatment', 'BFA', 'standard physical therapy and standard physical therapy plus battlefield acupuncture', 'Shoulder stabilization surgery', 'battlefield acupuncture', 'battlefield acupuncture (BFA']","['medication usage, Profile of Mood States, and Global Rating of Change', 'visual analog scale', 'shoulder instability']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}]",,0.183367,"The results of this study may help determine if BFA is an effective adjunct to physical therapy in reducing pain and opioid usage in acute pain conditions.
","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Crowell', 'Affiliation': 'Baylor University - Keller Army Community Hospital Division 1 Sports Physical Therapy Fellowship, West Point, NY, USA. michael_crowell@baylor.edu.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brindle', 'Affiliation': 'Baylor University - Keller Army Community Hospital Division 1 Sports Physical Therapy Fellowship, West Point, NY, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Mason', 'Affiliation': 'Baylor University - Keller Army Community Hospital Division 1 Sports Physical Therapy Fellowship, West Point, NY, USA.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Pitt', 'Affiliation': 'Baylor University - Keller Army Community Hospital Division 1 Sports Physical Therapy Fellowship, West Point, NY, USA.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Baylor University - Keller Army Community Hospital Division 1 Sports Physical Therapy Fellowship, West Point, NY, USA.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Posner', 'Affiliation': 'John A Feagin, Jr. Sports Medicine Fellowship, Keller Army Community Hospital, West Point, NY, USA.'}, {'ForeName': 'Kenneth L', 'Initials': 'KL', 'LastName': 'Cameron', 'Affiliation': 'John A Feagin, Jr. Sports Medicine Fellowship, Keller Army Community Hospital, West Point, NY, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Goss', 'Affiliation': 'Baylor University - Keller Army Community Hospital Division 1 Sports Physical Therapy Fellowship, West Point, NY, USA.'}]",Trials,['10.1186/s13063-020-04909-8']
2639,33272091,The Role of Heparin in Preventing the Early Silent Ischemia in Carotid Stenting.,"INTRODUCTION AND AIMS
Serebral silent ischemia is a complication of carotid stenting. If silent ischemia occur 24 hours later of carotid stenting, it called early serebral silent ischemia. The aim of this study was to evaluate the effect of heparin infusion on the prevention of early silent ischemia in patients who underwent carotid stenting.
MATERIALS AND METHODS
We included 26 patients who underwent carotid stenting. Patients who had carotid stenting, we randomized into two groups. The first group of patients was given contuniuously heparin infusion a maximum of 20000 units for 24 hours, and screened the aptt value each 6 hours. The aptt value aimed a range of 2-3 times to up baseline. The second group didin't take heparin infusion. Diffusion weighted magnetic resonance imaging (DWI-MRI) and gradient echo (GRE) sequences performed in all patients at the 24 hours of carotid stenting.
RESULTS
Early serebral silent ischemia was detected by DWI-MRI in 13 (50%) of 26 patients who underwent carotid stenting. Seven (53.80%) of 13 patients whit early serebral silent ischemia did not receive heparin treatment, while 6 (46.20%) received heparin treatment. There was no symptomatic or asymptomatic acute hemorrhage in patients who treated with heparin.
CONCLUSION
In our study, the continuation of anticoagulant therapy for 24 hours to prevent early silent ischemia was not statistically significant. Also there is no reduction for count of serebral silent ishemia between two groups. However, due to the small number of patients in the study, future studies are required with more patients.",2020,"RESULTS
Early serebral silent ischemia was detected by DWI-MRI in 13 (50%) of 26 patients who underwent carotid stenting.","['all patients at the 24\u2009hours of carotid stenting', 'Patients who had carotid stenting', 'patients who underwent carotid stenting', '26 patients who underwent carotid stenting']","['Heparin', 'heparin treatment', 'heparin', 'Diffusion weighted magnetic resonance imaging (DWI-MRI) and gradient echo (GRE) sequences', 'heparin infusion', 'contuniuously heparin']","['symptomatic or asymptomatic acute hemorrhage', 'early silent ischemia', 'count of serebral silent ishemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0333276', 'cui_str': 'Acute hemorrhage'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",26.0,0.056633,"RESULTS
Early serebral silent ischemia was detected by DWI-MRI in 13 (50%) of 26 patients who underwent carotid stenting.","[{'ForeName': 'Dilara Mermi', 'Initials': 'DM', 'LastName': 'Dibek', 'Affiliation': 'Department of Clinical Neurophysiology, Neurology Dokuz Eylül Üniversity of Medical Faculty, İzmir, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Ergun', 'Affiliation': 'Department of Radiology, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Mehmet Fevzi', 'Initials': 'MF', 'LastName': 'Öztekin', 'Affiliation': 'Department of Neurology, Diskapi Yildirim Beyazit Training and Research Hospital, Ankara, Turkey.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1858827']
2640,33272042,"Supplementation of Kaempferia parviflora Extract Enhances Physical Fitness and Modulates Parameters of Heart Rate Variability in Adolescent Student-Athletes: A Randomized, Double-Blind, Placebo-Controlled Clinical Study.","This randomized double-blind controlled study aimed to investigate the effects of a standardized Kaempferia parviflora (KP) extract on the physical fitness and heart rate variability (HRV) parameters in adolescent sport school students. 194 male students were recruited and randomized into two groups ( n = 97), matched by age and sports. The KP-treated group received KP extract capsules at a dose of 360 mg/day and the control group received placebo capsules, continuously for 12 weeks. Physical fitness performance and HRV parameters were monitored with blood biochemical analysis for product safety. KP extract significantly increased the right-hand grip strength, the back-leg strength and maximal oxygen consumption (VO 2 max) and decreased the time used for 50-meter sprint test without changing the sit-and-reach test and the 40 yard technical test. For HRV parameters, KP extract significantly increased standard deviation of normal to normal intervals (SDNN), square root of the mean of square of successive normal to normal interval differences (RMSSD) and high frequency (HF) norm, without changing low frequency (LF) norm and LF/HF ratio. The increase in stress resistance and decrease in stress index were found in the KP-treated group, without changing the autonomic nervous system (ANS) activity and balance. Blood biochemical analysis showed normal values of all participants. This data indicates the safety and positive effects of KP on muscle strength, endurance and speed, but not on the flexibility and agility. The modulatory effects of KP extract on HRV parameters suggest its anti-stress effects and would encourage the application in a sport training and exercise.",2020,"KP extract significantly increased the right-hand grip strength, the back-leg strength and maximal oxygen consumption (VO 2 max) and decreased the time used for 50-meter sprint test without changing the sit-and-reach test and the 40 yard technical test.","['194 male students', 'Adolescent Student-Athletes', 'adolescent sport school students']","['KP', 'KP extract capsules', 'placebo capsules', 'Kaempferia parviflora Extract', 'KP extract', 'Placebo', 'standardized Kaempferia parviflora (KP) extract']","['physical fitness and heart rate variability (HRV) parameters', 'Physical fitness performance and HRV parameters', 'standard deviation of normal to normal intervals (SDNN), square root of the mean of square of successive normal to normal interval differences (RMSSD) and high frequency (HF) norm, without changing low frequency (LF) norm and LF/HF ratio', 'stress index', 'muscle strength, endurance and speed', 'autonomic nervous system (ANS) activity and balance', 'flexibility and agility', 'Physical Fitness and Modulates Parameters of Heart Rate Variability', 'stress resistance', 'right-hand grip strength, the back-leg strength and maximal oxygen consumption (VO 2 max']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4042873', 'cui_str': 'Adolescent Sports'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1044692', 'cui_str': 'Kaempferia'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1319164', 'cui_str': 'Physical fitness behavior'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",194.0,0.0775426,"KP extract significantly increased the right-hand grip strength, the back-leg strength and maximal oxygen consumption (VO 2 max) and decreased the time used for 50-meter sprint test without changing the sit-and-reach test and the 40 yard technical test.","[{'ForeName': 'Bungorn', 'Initials': 'B', 'LastName': 'Sripanidkulchai', 'Affiliation': 'Center for Research and Development of Herbal Health Products, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Kreeta', 'Initials': 'K', 'LastName': 'Promthep', 'Affiliation': 'Physical Education and Health Education Program, Faculty of Education, Udon Thani Rejabhat University, Udon Thani, Thailand.'}, {'ForeName': 'Sarunya', 'Initials': 'S', 'LastName': 'Tuntiyasawasdikul', 'Affiliation': 'Center for Research and Development of Herbal Health Products, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Peera', 'Initials': 'P', 'LastName': 'Tabboon', 'Affiliation': 'Center for Research and Development of Herbal Health Products, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Rosawan', 'Initials': 'R', 'LastName': 'Areemit', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}]",Journal of dietary supplements,['10.1080/19390211.2020.1852356']
2641,33272036,"Microvascular Assessment of Ranolazine in Non-Obstructive Atherosclerosis: The MARINA Randomized, Double-Blinded, Controlled Pilot Trial.","BACKGROUND
Microvascular dysfunction is known to play a key role in patients with angina and nonobstructive coronary artery disease. We investigated the impact of ranolazine among patients with angina and nonobstructive coronary artery disease.
METHODS
In this randomized, double-blinded, placebo-controlled pilot trial, 26 patients with angina once weekly or more, abnormal stress test, and nonobstructive coronary artery disease (<50% stenosis by angiography and fractional flow reserve >0.80) were randomized 1:1 to ranolazine or placebo for 12 weeks. Primary end point was ∆Seattle Angina Questionnaire (SAQ) angina frequency score. Baseline and 3 months follow-up SAQ, Duke Activity Status Index scores along with invasive fractional flow reserve, coronary flow reserve (CFR), hyperemic myocardial resistance, and cardiopulmonary exercise testing measurements were performed.
RESULTS
No significant differences in ∆SAQ angina frequency scores ( P =0.53) or Duke Activity Status Index ( P =0.76) were observed between ranolazine versus placebo, although patients on ranolazine had lesser improvement in SAQ physical limitation scores ( P =0.02) compared with placebo at 3 months. There were no significant differences in ∆CFR or ∆hyperemic myocardial resistance between ranolazine and placebo groups. Patients treated with ranolazine, compared with placebo, had no significant improvement in maximum rate of oxygen consumption measured during incremental exercise (VO 2 max) and peak metabolic equivalents of task. Interestingly, in the ranolazine group, patients with baseline CFR<2.0 demonstrated greater gain in CFR compared with those with baseline CFR≥2.0 ( P =0.02).
CONCLUSIONS
Ranolazine did not demonstrate improvement in SAQ angina frequency score, invasive microvascular function, or peak metabolic equivalent compared with placebo at 3 months.
REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02147067.",2020,There were no significant differences in ∆CFR or ∆hyperemic myocardial resistance between ranolazine and placebo groups.,"['patients with angina and nonobstructive coronary artery disease', 'Obstructive Atherosclerosis', '26 patients with angina once weekly or more, abnormal stress test, and nonobstructive coronary artery disease (<50% stenosis by angiography and fractional flow reserve >0.80']","['ranolazine', 'ranolazine or placebo', 'Ranolazine', 'placebo']","['∆CFR or ∆hyperemic myocardial resistance', 'maximum rate of oxygen consumption', 'SAQ physical limitation scores', 'SAQ angina frequency score, invasive microvascular function, or peak metabolic equivalent', 'Duke Activity Status Index scores along with invasive fractional flow reserve, coronary flow reserve (CFR), hyperemic myocardial resistance, and cardiopulmonary exercise testing measurements', '∆Seattle Angina Questionnaire (SAQ) angina frequency score', 'peak metabolic equivalents of task', 'Duke Activity Status Index', 'greater gain in CFR', '∆SAQ angina frequency scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0149612', 'cui_str': 'Exercise tolerance test abnormal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}]","[{'cui': 'C0073633', 'cui_str': 'ranolazine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3695257', 'cui_str': 'Frequency of angina'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2983100', 'cui_str': 'Metabolic equivalent of task'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",26.0,0.42373,There were no significant differences in ∆CFR or ∆hyperemic myocardial resistance between ranolazine and placebo groups.,"[{'ForeName': 'Jin-Sin', 'Initials': 'JS', 'LastName': 'Koh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Gyeongsang National University School of Medicine and Gyeongsang National University Hospital, Jinju, Republic of Korea (J.-S.K.).'}, {'ForeName': 'Olivia Y', 'Initials': 'OY', 'LastName': 'Hung', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Eshtehardi', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Arnav', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Interventional Cardiology, Emory University School of Medicine, Atlanta, GA (A.K.).'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Rabah', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Raad', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Sundeep', 'Initials': 'S', 'LastName': 'Chaudhry', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Sonu', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Research and Development, MET-TEST, Inc, Atlanta, GA (S.C.).'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Hosseini', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Brilakis', 'Affiliation': 'Minneapolis Heart Institute, MN (E.B.).'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Corban', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic College of Medicine and Science, Rochester, MN (M.C.).'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Sabbak', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Grady Murphy', 'Initials': 'GM', 'LastName': 'Burnett', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Puja K', 'Initials': 'PK', 'LastName': 'Mehta', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Samady', 'Affiliation': 'Andreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, GA (J.-S.K., O.Y.H., P.E., R.R., M.R., S.K., S.G., H.H., N.S., G.M.B., C.L., P.K.M., A.A.Q., H.S.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008204']
2642,33272034,A Randomized Trial Evaluating Online 3-Dimensional Optical Frequency Domain Imaging-Guided Percutaneous Coronary Intervention in Bifurcation Lesions.,"BACKGROUND
Clinical implications of online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting for bifurcation lesions have not been investigated in the randomized controlled trials. The purpose of this study was to determine whether online 3D-OFDI-guided stenting is superior to angiography-guided percutaneous coronary intervention (PCI) in terms of incomplete stent apposition at the bifurcation segment.
METHODS
The OPTIMUM trial (Online 3-Dimensional Optical Frequency Domain Imaging to Optimize Bifurcation Stenting Using UltiMaster Stent) was a randomized, multicenter clinical trial. Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent. Patients were randomly allocated to either online 3D-OFDI-guided or angiography-guided PCI. Patients randomized to 3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance. The primary end point of this trial was the postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches.
RESULTS
Between June 8, 2017 and September 26, 2018, 110 patients with 111 bifurcation lesions were randomized at 4 Japanese centers. Of these, 56 patients with 57 lesions were treated with 3D-OFDI-guided PCI, whereas 54 patients with 54 lesions were treated with angiography-guided PCI. In the 3D-OFDI guidance arm, the feasibility of online 3D-OFDI was 98.2%. The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P =0.008). The superiority of the 3D-OFDI guidance arm was also confirmed in the strut level analysis (odds ratio: 0.54 [95% CI, 0.36-0.81]; P =0.003).
CONCLUSIONS
Online 3D-OFDI-guided bifurcation PCI was superior to angiography-guided bifurcation PCI in terms of acute incomplete stent apposition at bifurcation.
REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02972489.",2020,"The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P =0.008).","['Bifurcation Lesions', '56 patients with 57 lesions', 'Eligible patients had an angiographically significant stenosis in the bifurcation lesion treated with a provisional single stent strategy using the Ultimaster sirolimus eluting stent', 'Between June 8, 2017 and September 26, 2018', '54 patients with 54 lesions', '110 patients with 111 bifurcation lesions']","['3D-OFDI guidance underwent online 3D-OFDI assessment after rewiring into the jailed side branch after stenting and proximal optimization technique, while in the angiography guidance arm, rewiring was performed using conventional fluoroscopic/angiographic guidance', 'angiography-guided percutaneous coronary intervention (PCI', 'Online 3-Dimensional Optical Frequency Domain Imaging-Guided Percutaneous Coronary Intervention', 'angiography-guided PCI', 'online 3D-OFDI-guided or angiography-guided PCI', '3D-OFDI-guided PCI', 'online 3-dimensional optical frequency domain imaging (3D-OFDI)-guided stenting', 'online 3D-OFDI-guided stenting']","['average percentage of incomplete stent apposition per lesion at bifurcation', 'postprocedural average percentage of malapposed struts per lesion assessed by OFDI in the confluence zone of the main and side branches']","[{'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4517538', 'cui_str': '111'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1443259', 'cui_str': 'Incomplete stent apposition'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C4682863', 'cui_str': 'Volumetric laser endomicroscopy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}]",110.0,0.0938018,"The average percentage of incomplete stent apposition per lesion at bifurcation was lower in the 3D-OFDI guidance arm than that in the angiography guidance arm (19.5±15.8% versus 27.5±14.2%, P =0.008).","[{'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan (Y.O., T.M., Y. Ozaki).'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (N.K., T.A., K.T., H.K., M.O., Y.K.).'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Sotomi', 'Affiliation': 'Department of Cardiology, Osaka Police Hospital, Japan (Y.S., S.N.).'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Miyazaki', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan (Y.M., T.O.).'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Asano', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (N.K., T.A., K.T., H.K., M.O., Y.K.).'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (N.K., T.A., K.T., H.K., M.O., Y.K.).'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (N.K., T.A., K.T., H.K., M.O., Y.K.).'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (N.K., T.A., K.T., H.K., M.O., Y.K.).'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Katagiri', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, the Netherlands (N.K., T.A., K.T., H.K., M.O., Y.K.).'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kyono', 'Affiliation': ''}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Nakatani', 'Affiliation': 'Department of Cardiology, Osaka Police Hospital, Japan (Y.S., S.N.).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Muramatsu', 'Affiliation': 'Department of Cardiology, Cardiovascular Center, Fujita Health University Hospital, Toyoake, Japan (Y.O., T.M., Y. Ozaki).'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Sharif', 'Affiliation': 'Department of Cardiology, University Hospital Galway (F.S.).'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway (Y.O., P.W.S.).'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland Galway (Y.O., P.W.S.).'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan (Y.M., T.O.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.120.009183']
2643,33276322,Bilateral Dorsolateral Prefrontal Cortex High-Definition Transcranial Direct-Current Stimulation Improves Time-Trial Performance in Elite Cyclists.,"BACKGROUND
The effects of anodal transcranial direct-current stimulation (tDCS) on endurance exercise performance are not yet fully understood. Different stimulated areas and low focality of classical tDCS technique may have led to discordant results.
PURPOSE
This study investigated the effect of a bilateral anodal high-definition tDCS (HD-tDCS) of the dorsolateral prefrontal cortex on the cycling time-trial (TT) performance and physiological and perceptual response at moderate intensity in elite cyclists.
METHODS
A total of 8 elite cyclists (maximal oxygen consumption: 72.2 [4.3] mL·min-1·kg-1) underwent in a double-blind, counterbalanced, and randomized order the experimental treatment (HD-tDCS) or control treatment (SHAM). After 20 minutes of receiving either HD-tDCS on the dorsolateral prefrontal cortex (F3 and F4) or SHAM stimulation, the participants completed a constant-load trial (CLT) at 75% of the second ventilatory threshold. Thereafter, they performed a simulated 15-km TT. The ratings of perceived exertion, heart rate, cadence, oxygen consumption, and respiratory exchange ratio were recorded during the CLT; the ratings of perceived exertion and heart rate were recorded during the TT.
RESULTS
The total time to complete the TT was 1.3% faster (HD-tDCS: 1212 [52] s vs SHAM: 1228 [56] s; P = .04) and associated with a higher heart rate (P < .001) and a tendency toward higher mean power output (P = .05). None of the physiological and perceptual variables measured during the CLT highlighted differences between the HD-tDCS and SHAM condition.
CONCLUSIONS
The findings suggest that bilateral HD-tDCS on the dorsolateral prefrontal cortex improves cycling TT performance without altering the physiological and perceptual response at moderate intensity, indicating that an upregulation of the prefrontal cortex could enhance endurance exercise performance.",2020,"None of the physiological and perceptual variables measured during the CLT highlighted differences between the HD-tDCS and SHAM condition.
","['elite cyclists', 'Elite Cyclists', '8 elite cyclists (maximal oxygen consumption: 72.2 [4.3']","['experimental treatment (HD-tDCS) or control treatment (SHAM', 'SHAM', 'anodal transcranial direct-current stimulation (tDCS', 'Bilateral Dorsolateral Prefrontal Cortex High-Definition Transcranial Direct-Current Stimulation', 'mL·min-1·kg-1', 'bilateral anodal high-definition tDCS (HD-tDCS', 'HD-tDCS']","['heart rate', 'total time to complete the TT', 'cycling time-trial (TT) performance and physiological and perceptual response', 'cycling TT performance', 'ratings of perceived exertion, heart rate, cadence, \xa0oxygen consumption, and respiratory exchange ratio', 'endurance exercise performance', 'ratings of perceived exertion and heart rate']","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C4517759', 'cui_str': '4.3'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]",,0.155933,"None of the physiological and perceptual variables measured during the CLT highlighted differences between the HD-tDCS and SHAM condition.
","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pollastri', 'Affiliation': ''}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': ''}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Zucca', 'Affiliation': ''}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Filipas', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': ''}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Riba', 'Affiliation': ''}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Molino', 'Affiliation': ''}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Geda', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0910']
2644,33276294,Effect of non-sedation on physical function in survivors of critical illness - A substudy of the NONSEDA randomized trial.,"PURPOSE
Critical illness impairs physical function. The NONSEDA trial was a multicenter randomized trial, assessing non-sedation versus sedation during mechanical ventilation. The aim of this sub-study was to assess the effect of non-sedation on physical function.
METHODS
All patients from one NONSEDA trial site were included. At ICU discharge and three months thereafter, survivors were assessed for physical function.
RESULTS
205 patients were included, 118 survived to follow-up, 116 participated (98%).
PRIMARY OUTCOME
Three months after ICU-discharge, health-related quality of life (SF-36, physical component score) was similar (non-sedated 38.3 vs sedated 36.6, mean difference 1.7, 95% CI -1.7 to 5.1), as was function in activities of daily living (Barthel Index, non-sedated 19.5 vs sedated 18, median difference 1.5, 95% CI -0.2 to 3.2).
SECONDARY OUTCOMES
Non-sedated patients had a better Barthel Index at ICU-discharge (median 9 vs 4, median difference 5, 95% CI 2.5 to 7.5). At three months post-ICU discharge, the two groups did not differ regarding handgrip strength, walking distance, muscle size or biomechanical data.
CONCLUSION
Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living. Non-sedated patients had a better physical recovery at ICU discharge.
TRIAL REGISTRATION
Clinicaltrials.govNCT02034942, registered January 14., 2014.",2020,"CONCLUSION
Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living.","['survivors of critical illness', 'All patients from one NONSEDA trial site were included', '205 patients were included, 118 survived to follow-up, 116 participated (98']",['non-sedation'],"['handgrip strength, walking distance, muscle size or biomechanical data', 'health-related quality of life (SF-36, physical component score', 'physical function', 'function in activities of daily living (Barthel Index', 'better Barthel Index at ICU-discharge']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",205.0,0.307946,"CONCLUSION
Non-sedation did not lead to improved quality of life regarding physical function or better function in activities of everyday living.","[{'ForeName': 'Helene K', 'Initials': 'HK', 'LastName': 'Nedergaard', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Sygehusvej 24, 6000 Kolding, Denmark; Department of Clinical Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark. Electronic address: helene.korvenius.nedergaard@rsyd.dk.'}, {'ForeName': 'Hanne Irene', 'Initials': 'HI', 'LastName': 'Jensen', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Lillebaelt Hospital, University Hospital of Southern Denmark, Kolding, Sygehusvej 24, 6000 Kolding, Denmark; Department of Regional Health Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark.'}, {'ForeName': 'Hanne Tanghus', 'Initials': 'HT', 'LastName': 'Olsen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, J.B. Winsløwsvej 19, 5000 Odense, Denmark; Department of Anesthesiology and Intensive Care, Odense University Hospital, Svendborg, Baagoees alle 15, 5700 Svendborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Strøm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, J. B. Winsloevsvej 4, 5000 Odense, Denmark.'}, {'ForeName': 'Jørgen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Sjøgaard', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, J. B. Winsloevsvej 4, 5000 Odense, Denmark.'}]",Journal of critical care,['10.1016/j.jcrc.2020.11.017']
2645,33276274,The mediating role of insomnia severity in internet-based cognitive behavioral therapy for chronic stress: Secondary analysis of a randomized controlled trial.,"The aim of this study was to investigate insomnia symptom severity as a putative mediator of treatment response in therapist-guided internet-based cognitive behavioral therapy (ICBT) for chronic stress, using data from a randomized controlled trial. Participants (N = 100) were randomized to 12 weeks of ICBT or to a waitlist control condition (WLC). Insomnia severity was assessed weekly with the Insomnia Severity Index (ISI), as were the stress-related outcomes the Perceived Stress Scale (PSS) and the Shirom-Melamed Burnout Questionnaire (SMBQ). Latent growth models indicated that ICBT (vs. WLC) predicted a decrease in insomnia severity (α-path), and that growth in insomnia severity was predictive of growth in perceived stress and exhaustion (β-paths). Most importantly, there were also significant indirect effects (αβ products) such that the beneficial effects of ICBT on perceived stress and exhaustion were mediated by a reduction in insomnia symptom severity (PSS: αβ = -0.44, 95% CI [-0.92, -0.14]; SMBQ: αβ = -0.08, 95% CI [-0.15, -0.04]). Explorative analysis of moderated mediation showed that more severe insomnia symptoms at baseline were associated with larger mediated effects. We conclude that reducing insomnia severity could be of importance for achieving successful treatment outcomes in ICBT for chronic stress.",2020,"Latent growth models indicated that ICBT (vs. WLC) predicted a decrease in insomnia severity (α-path), and that growth in insomnia severity was predictive of growth in perceived stress and exhaustion (β-paths).","['Participants (N\xa0=\xa0100', 'chronic stress']","['ICBT (vs. WLC', 'waitlist control condition (WLC', 'therapist-guided internet-based cognitive behavioral therapy (ICBT', 'ICBT', 'internet-based cognitive behavioral therapy']","['severe insomnia symptoms', 'SMBQ', 'Insomnia severity', 'insomnia severity (α-path', 'insomnia symptom severity', 'Insomnia Severity Index (ISI', 'Perceived Stress Scale (PSS) and the Shirom-Melamed Burnout Questionnaire (SMBQ']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}]",100.0,0.097702,"Latent growth models indicated that ICBT (vs. WLC) predicted a decrease in insomnia severity (α-path), and that growth in insomnia severity was predictive of growth in perceived stress and exhaustion (β-paths).","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Lindsäter', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden. Electronic address: elin.lindsater@ki.se.'}, {'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sigrid', 'Initials': 'S', 'LastName': 'Salomonsson', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Santoft', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Center for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Åkerstedt', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Stress Research Institute, Department of Psychology, Stockholm University, Stockholm, Sweden; Osher Center for Integrative Medicine, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Osher Center for Integrative Medicine, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103782']
2646,33276267,Effects of parental presence during induction of anesthesia on operative and perioperative times in pediatric patients undergoing adenotonsillectomy.,"OBJECTIVES
To evaluate the overall perioperative times among pediatric patients undergoing adenotonsillectomy (AT) who, in the perioperative period, received either parental presence at induction of anesthesia (PPIA), midazolam, both, or neither.
METHODS
A retrospective chart review of patients under the age of twelve years who underwent AT during 2018 was performed at a tertiary children's hospital. Exclusion criteria were: patients with concomitant procedures done at the time of AT, American Society of Anesthesiologists (ASA) score greater than 3, or unclear documentation of PPIA participation. Patients were categorized into one of four groups: those who received PPIA, those who received midazolam, and those who received both or neither. Time spent in holding, the operating room, and in recovery were recorded. For comparison of continuous variables, either a One-Way ANOVA or a Kruskal-Wallis test was used as appropriate with post-hoc comparisons using a Dunn's Test.
RESULTS
A total of 274 patient charts were reviewed. After application of exclusion criteria, 152 charts were included for analysis. A total of 69 patients had PPIA alone, 18 received midazolam alone, 57 received both, and 8 had neither. The median age of the patients was 5.34 years (range 0.62-11.97). There was no significant difference in median time in holding between groups, but there was a significant difference in both OR and recovery time (p = 0.005 and p = 0.021 respectively). On further analysis with post-hoc pairwise comparisons, the only significant difference was between the midazolam only group and the group who received both PPIA and midazolam (p < 0.05), with patients receiving both having a shorter OR duration.
CONCLUSION
Patients who received both PPIA and midazolam had a shorter OR duration than patients in the midazolam only group. There were no significant differences found in holding time or recovery time between groups. This supports the conclusion that PPIA can be implemented when deemed appropriate without increasing time spent in the operating room and may even have a beneficial effect when compounded with midazolam.",2020,"There was no significant difference in median time in holding between groups, but there was a significant difference in both OR and recovery time (p = 0.005 and p = 0.021 respectively).","['69 patients had PPIA alone, 18 received', 'pediatric patients undergoing adenotonsillectomy (AT) who, in the perioperative period, received either', 'pediatric patients undergoing adenotonsillectomy', '274 patient charts were reviewed', 'Exclusion criteria were: patients with concomitant procedures done at the time of AT, American Society of Anesthesiologists (ASA) score greater than 3, or unclear documentation of PPIA participation', ""patients under the age of twelve years who underwent AT during 2018 was performed at a tertiary children's hospital""]","['midazolam', 'parental presence at induction of anesthesia (PPIA), midazolam, both, or neither', 'anesthesia']","['OR and recovery time', 'shorter OR duration', 'median time in holding', 'holding time or recovery time', 'Time spent in holding, the operating room, and in recovery']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C1268547', 'cui_str': 'Patient chart'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}]",69.0,0.087508,"There was no significant difference in median time in holding between groups, but there was a significant difference in both OR and recovery time (p = 0.005 and p = 0.021 respectively).","[{'ForeName': 'Sydney L', 'Initials': 'SL', 'LastName': 'Moseley', 'Affiliation': 'College of Medicine, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: moselesy@musc.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Heine', 'Affiliation': 'Department of Anesthesiology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: heinec@musc.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Valente', 'Affiliation': 'Department of Otolaryngology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA; Department of Anesthesiology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA; College of Medicine, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: valentet@musc.edu.'}, {'ForeName': 'Drew', 'Initials': 'D', 'LastName': 'Stone', 'Affiliation': 'College of Medicine, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: stonedr@musc.edu.'}, {'ForeName': 'Dylan A', 'Initials': 'DA', 'LastName': 'Levy', 'Affiliation': 'Department of Otolaryngology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA; Department of Anesthesiology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA; College of Medicine, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: levyd@musc.edu.'}, {'ForeName': 'Jaye Bea', 'Initials': 'JB', 'LastName': 'Downs', 'Affiliation': 'Department of Otolaryngology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: jayebdowns@gmail.com.'}, {'ForeName': 'Shaun A', 'Initials': 'SA', 'LastName': 'Nguyen', 'Affiliation': 'Department of Otolaryngology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: nguyensh@musc.edu.'}, {'ForeName': 'Phayvanh P', 'Initials': 'PP', 'LastName': 'Pecha', 'Affiliation': 'Department of Otolaryngology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: pechap@musc.edu.'}, {'ForeName': 'Clarice', 'Initials': 'C', 'LastName': 'Clemmens', 'Affiliation': 'Department of Otolaryngology, Medical University of South Carolina, 171 Ashley Avenue, Charleston, SC, 29425, USA. Electronic address: clemmens@musc.edu.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110515']
2647,33276176,Effect of Health Care and Rehabilitation Nursing and Analysis of Neurovascular Preservation of Patients Undergoing Reconstruction of Severed Finger under X-ray Image Examination.,"OBJECTIVE
the study aimed to provide a guideline for continuous rehabilitation nursing for patients with severe finger replantation, establish a satellite contact point for patients with severe finger replantation after discharge, so as to ensure scientific and effective rehabilitation training after discharge and explore the role of continuous rehabilitation nursing measurement in severe finger rehabilitation and neurovascular preservation.
METHODS
a total of 380 patients accepting neurovascular preservation finger replantation in hand surgery department were divided into observation group and control group according to the number of hospitalizations. All patients underwent reconstructive surgery of severed finger. X-ray was used to monitor the postoperative nursing effect of neurovascular preservation of severed finger. The discharged patient information questionnaire was filled 3 days before the discharge. Then, a patient information database was established, and rehabilitation training was performed. Finally, sexual rehabilitation nursing follow-up intervention, telephone follow-up, and cross-referring intervention were carried out. Postoperative X-ray images were taken regularly to observe the recovery of reconstructed finger.
RESULTS
there was no difference in daily life ability scores and hand function scores between the two groups at discharge (P> 0.05). The daily life ability scores and hand function scores of the observation group were better than those of the control group at 1 and 6 months after discharge (P <0.05), the difference is statistically significant. As the discharge time prolonged, the daily life ability score and hand function score of the two groups of patients gradually increased. X-ray images showed that the replanted finger body was well developed, phalanx was in good antithesis, and there was no epiphysis.
CONCLUSION
continuous rehabilitation nursing measures should be taken after the replantation of the severed finger after neurovascular preservation, which provides standardized rehabilitation training standards for patients with replantation of severed finger after discharge, improves patient training compliance, promotes hand function recovery as soon as possible, and enables patients to return to society as soon as possible, which is worthy of clinical promotion and application.",2020,there was no difference in daily life ability scores and hand function scores between the two groups at discharge (P> 0.05).,"['All patients underwent reconstructive surgery of severed finger', 'patients with severe finger replantation, establish a satellite contact point for patients with severe finger replantation after discharge', '380 patients accepting neurovascular preservation finger replantation in hand surgery department', 'Patients Undergoing Reconstruction of Severed Finger under X-ray Image Examination']",['Health Care and Rehabilitation Nursing'],"['discharge time prolonged, the daily life ability score and hand function score', 'daily life ability scores and hand function scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0264097', 'cui_str': 'Calcaneal apophysitis'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0408894', 'cui_str': 'Reattachment of finger'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0036238', 'cui_str': 'Associated Viruses'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0587521', 'cui_str': 'Hand surgery department'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0376427', 'cui_str': 'Nursing, Rehabilitation'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}]",380.0,0.0179049,there was no difference in daily life ability scores and hand function scores between the two groups at discharge (P> 0.05).,"[{'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Department 4 of Orthopedics 4, Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang City, 050000, Hebei Province, China;. Electronic address: maronghua366@163.com.'}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Du', 'Affiliation': 'Department 2 of Spine, Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang City, 050000, Hebei Province, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department 3 of Hand Surgery, Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang City, 050000, Hebei Province, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department 3 of Hand Surgery, Third Hospital of Hebei Medical University, 139 Ziqiang Road, Shijiazhuang City, 050000, Hebei Province, China.'}]",World neurosurgery,['10.1016/j.wneu.2020.10.071']
2648,33276166,A Commentary on Coffee consumption for recovery of intestinal function after laparoscopic gynecological surgery: A randomized controlled trial (Int J Surg 2020; 82:130-5).,,2020,,['after laparoscopic gynecological surgery'],['Coffee consumption'],['intestinal function'],"[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.329813,,"[{'ForeName': 'Pawel Korolkiewicz', 'Initials': 'PK', 'LastName': 'Shan Ali', 'Affiliation': 'Scientific Circle of Neurology and Neurosurgery, Medical University of Gdansk, Poland. Dębinki 7, Gdansk, Poland, 80-952. Electronic address: pawelkorolkiewicz@gumed.edu.pl.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Szmuda', 'Affiliation': 'Neurosurgery Department, Medical University of Gdansk, Poland. Dębinki 7, Gdansk, Poland, 80-952.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Słoniewski', 'Affiliation': 'Neurosurgery Department, Medical University of Gdansk, Poland. Dębinki 7, Gdansk, Poland, 80-952.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.11.023']
2649,33276165,"A commentary on ""Randomized clinical trial comparing side to end vs end to end techniques for colorectal anastomosis."" (Int J Surg 2020; 83:220-9).",,2020,,[],[],[],[],[],[],,0.0559624,,"[{'ForeName': 'Sharmananthan', 'Initials': 'S', 'LastName': 'Ganesananthan', 'Affiliation': 'University College London Medical School, Whittington Hospital, United Kingdom.'}, {'ForeName': 'Sashiananthan', 'Initials': 'S', 'LastName': 'Ganesananthan', 'Affiliation': 'School of Medicine, Cardiff University, University Hospital of Wales, United Kingdom.'}, {'ForeName': 'Sanjeev Chaand', 'Initials': 'SC', 'LastName': 'Sharma', 'Affiliation': 'Whittington Hospital, Magdala Ave, London N19 5NF.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.11.024']
2650,33276145,Targeting self-control as a behavior change mechanism to increase physical activity: Study protocol of a randomized controlled trial.,"Despite the highly publicized beneficial effects of physical activity, 51.1% of middle-aged US adults do not achieve the recommended minimum of aerobic physical activity needed to maintain health. A sedentary lifestyle can be attributed in part to a lack of self-control and there is some evidence that self-control strategies can be improved with targeted interventions. The overall aim of this study is to test self-control as a behavior change mechanism for physical activity and to investigate whether a smartphone-based self-control intervention can increase physical activity among sedentary middle-aged adults. This protocol describes the design of a randomized controlled trial with two experimental conditions: The self-control treatment group and the control group. Both groups track their daily physical activity using a Fitbit step counter for eight weeks. Additionally, the self-control intervention group receives a 7-week smartphone-based self-control intervention to learn strategies how to potentiate desirable impulses or weaken undesirable ones. It is expected that the self-control treatment group will show greater increases in physical activity and that changes last longer compared to the control group. All participants will be assessed at pretest (baseline), at the end of each week (weeks 1-7), at posttest (week 8), and at follow-up (week 12). If this self-control intervention proves effective, this digital approach would represent a low-threshold and cost-effective approach to increasing physical activity. Such an intervention could be delivered to a large number of people to improve their health outcomes in the long run. Trial Registration:ClinicalTrials.gov: NCT04522141.",2020,It is expected that the self-control treatment group will show greater increases in physical activity and that changes last longer compared to the control group.,['sedentary middle-aged adults'],['smartphone-based self-control intervention'],['physical activity'],"[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0395786,It is expected that the self-control treatment group will show greater increases in physical activity and that changes last longer compared to the control group.,"[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Stieger', 'Affiliation': 'Department of Psychology, Brandeis University, USA. Electronic address: stieger@brandeis.edu.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Allemand', 'Affiliation': 'Department of Psychology & URPP Dynamics of Healthy Aging, University of Zurich, Switzerland. Electronic address: m.allemand@psychologie.uzh.ch.'}, {'ForeName': 'Margie E', 'Initials': 'ME', 'LastName': 'Lachman', 'Affiliation': 'Department of Psychology, Brandeis University, USA. Electronic address: lachman@brandeis.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106236']
2651,33276125,Intrauterine devices and sexually transmitted infection among older adolescents and young adults in a cluster randomized trial.,"STUDY OBJECTIVE
Provider misconceptions regarding intrauterine device safety for adolescents and young women can unnecessarily limit contraceptive options offered; we sought to evaluate rates of N gonorrhaeae or C trachomatis diagnoses among young women adopting intrauterine devices.
DESIGN
Secondary analysis of a cluster-randomized provider educational trial.
SETTING
40 U.S.-based reproductive health centers.
PARTICIPANTS
1,350 participants aged 18-25 seeking contraceptive care were followed for 12-months.
INTERVENTIONS
. The parent study assessed the impact of a provider training on evidence-based contraceptive counseling.
MAIN OUTCOME MEASURES
. We assessed incidence of N gonorrhaeae or C trachomatis (GC/CT) diagnoses by IUD use and sexually transmitted infection risk factors using Cox regression modeling and generalized estimating equations.
RESULTS
204 participants had GC/CT history at baseline; 103 received a new GC/CT diagnosis over 12-month follow-up. IUDs were initiated by 194 participants. Incidence of GC/CT diagnosis was 10.0 per 100 person-years during IUD use vs. 8.0 otherwise. In adjusted models, IUD use (aHR 1.31, 95% CI 0.71-2.40), adolescent age (aHR 1.28, 95% CI 0.72-2.27), history of GC/CT (aHR 1.23, 95% CI 0.75-2.00) and intervention status (aHR 1.12, 95% CI 0.74-1.71) were not associated with GC/CT diagnosis; however, new GC/CT diagnosis rates were significantly higher among individuals reporting multiple partners at baseline (aHR 2.0, 95%CI 1.34-2.98).
CONCLUSION
In this young study population with GC/CT history, this use of intrauterine devices was safe and did not lead to increased GC/CT diagnoses. However, results highlighted the importance of dual sexually transmitted infection and pregnancy protection for participants with multiple partners.",2020,"In adjusted models, IUD use (aHR 1.31, 95% CI 0.71-2.40), adolescent age (aHR 1.28, 95% CI 0.72-2.27), history of GC/CT (aHR 1.23, 95% CI 0.75-2.00) and intervention status (aHR 1.12, 95% CI 0.74-1.71) were not associated with GC/CT diagnosis; however, new GC/CT diagnosis rates were significantly higher among individuals reporting multiple partners at baseline (aHR 2.0, 95%CI 1.34-2.98).
","['40 U.S.-based reproductive health centers', '204 participants had GC/CT history at baseline; 103 received a', '1,350 participants aged 18-25 seeking contraceptive care', 'adolescents and young women', 'older adolescents and young adults', 'participants with multiple partners', 'young women adopting intrauterine devices']","['Intrauterine devices', 'new GC/CT diagnosis', 'provider training']","['incidence of N gonorrhaeae or C trachomatis (GC/CT) diagnoses', 'new GC/CT diagnosis rates', 'history of GC/CT', 'Incidence of GC/CT diagnosis']","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0026767', 'cui_str': 'Multiple Partners'}, {'cui': 'C0425382', 'cui_str': 'Adopted'}, {'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}]","[{'cui': 'C0021900', 'cui_str': 'Intrauterine contraceptive device'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008151', 'cui_str': 'Chlamydia trachomatis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0262926', 'cui_str': 'History of'}]",1350.0,0.335279,"In adjusted models, IUD use (aHR 1.31, 95% CI 0.71-2.40), adolescent age (aHR 1.28, 95% CI 0.72-2.27), history of GC/CT (aHR 1.23, 95% CI 0.75-2.00) and intervention status (aHR 1.12, 95% CI 0.74-1.71) were not associated with GC/CT diagnosis; however, new GC/CT diagnosis rates were significantly higher among individuals reporting multiple partners at baseline (aHR 2.0, 95%CI 1.34-2.98).
","[{'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'El Ayadi', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA. Electronic address: alison.elayadi@ucsf.edu.'}, {'ForeName': 'Corinne H', 'Initials': 'CH', 'LastName': 'Rocca', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Averbach', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA; Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Darney', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Ashlesha', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Planned Parenthood Federation of America, New York, NY.'}, {'ForeName': 'Cynthia C', 'Initials': 'CC', 'LastName': 'Harper', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2020.11.022']
2652,33276115,"Treatment of halitosis with photodynamic therapy in older adults with complete dentures: a randomized, controlled, clinical trial.","BACKGROUND
Halitosis of an oral origin is mainly caused by the release of H2S by bacteria lodged on the tongue. Antimicrobial photodynamic therapy (aPDT) has been evaluated for the treatment of halitosis, but there are no previous reports of the use of this treatment modality in older people. The aim of the present study was to compare the effect of aPDT and tongue scraping (standard treatment) in older people with complete dentures diagnosed with halitosis (H2S gas concentration>112 ppb).
METHODS
The participants were divided into two groups: G1- treatment with a tongue scraper (n = 20); G2- treatment with aPDT (n = 20). Halimeter testing was performed before and after treatments using gas chromatography and was repeated after seven days.
RESULTS
After treatment, the group treated with aPDT had a lower mean concentration of H2S gas (18.5 ppb) than the tongue scraping group (185.3 ppb). After one week, the mean concentration of H2S increased to 218.2 ppb in the tongue scraping group and 39 ppb in the PDT group.
CONCLUSIONS
Both treatments were able to reduce the concentration of H2S but only treatment with aPDT was able to decrease halitosis to socially unnoticeable levels. Moreover, this normal breath condition remained for seven days only in the aPDT group.",2020,Both treatments were able to reduce the concentration of H2S but only treatment with aPDT was able to decrease halitosis to socially unnoticeable levels.,"['older people with complete dentures diagnosed with halitosis (H2S gas concentration>112\u2009ppb', 'older adults with complete dentures', 'older people']","['aPDT and tongue scraping (standard treatment', 'Antimicrobial photodynamic therapy (aPDT', 'halitosis with photodynamic therapy', 'aPDT', 'G1- treatment with a tongue scraper (n\u2009=\u200920); G2- treatment with aPDT']","['concentration of H2S', 'mean concentration of H2S', 'mean concentration of H2S gas']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}, {'cui': 'C2001403', 'cui_str': 'H2S(D2S)'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0032441', 'cui_str': 'Polybrominated biphenyl'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0444082', 'cui_str': 'Scrapings'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018520', 'cui_str': 'Breath smells unpleasant'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2001403', 'cui_str': 'H2S(D2S)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017110', 'cui_str': 'Gas'}]",,0.0480933,Both treatments were able to reduce the concentration of H2S but only treatment with aPDT was able to decrease halitosis to socially unnoticeable levels.,"[{'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Llanos do Vale', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil; Dentistry School, Nove de Julho University, UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: katiadovale7@gmail.com.'}, {'ForeName': 'Anna Carolina', 'Initials': 'AC', 'LastName': 'Ratto Tempestini Horliana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil; Dentistry School, Nove de Julho University, UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: annacrth@gmail.com.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Romero Dos Santos', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil; Dentistry School, Nove de Julho University, UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: sergioromero@uni9.pro.br.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Oppido Schalch', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: taniaschalch@gmail.com.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Melo de Ana', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: amdeana@gmail.com.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Agnelli Mesquita Ferrari', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil; Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: raquel.mesquita@gmail.com.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kalil Bussadori', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil; Dentistry School, Nove de Julho University, UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil; Postgraduate Program in Rehabilitation Sciences, Nove de Julho University, UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: sandra.skb@gmail.com.'}, {'ForeName': 'Kristianne', 'Initials': 'K', 'LastName': 'Porta Santos Fernandes', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil; Dentistry School, Nove de Julho University, UNINOVE, R. Vergueiro, 235/249, 01504-001, São Paulo, Brazil. Electronic address: kristianneporta@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.102128']
2653,33275795,A quasi-experimental pilot study to the effects of Responsive Aggression Regulation Therapy (Re-ART) Outpatient for young adults.,"It is important to provide treatment for juvenile and young adult violent offenders, since no or (too) late treatment increases the risk of recidivism and persistent aggressive behavior in adulthood. In this study, we investigated the efficacy of the intervention Responsive Aggression Regulation Therapy (Re-ART) Outpatient, which has been developed for adolescents and young adults between 16 and 24 years old with severe aggression problems. This quasi-experimental (pilot) study compared the effects of Re-ART Outpatient (n = 47) with a control group (n = 29) receiving treatment as usual on measures regarding risk of violent recidivism, impulsivity, emotional/personal functioning, family functioning, motivation, handling anger, self-reported problem behavior, coping skills, and cognitive distortions. Re-ART showed significantly better results than the control group on risk of violent recidivism, impulsivity, emotional/personal functioning, motivation, handling anger, certain coping skills, and certain cognitive distortions. Family functioning and self-reported rule-breaking behavior did not differ significantly between the groups. The results implicate that Re-ART is a promising outpatient intervention for young adults with severe aggressive behavior. The results can be explained by the fact that Re-ART treats both systemically and individually and pays specific attention to stress reduction and the improvement of executive functions.",2020,"Re-ART showed significantly better results than the control group on risk of violent recidivism, impulsivity, emotional/personal functioning, motivation, handling anger, certain coping skills, and certain cognitive distortions.","['young adults', 'young adults with severe aggressive behavior', 'adolescents and young adults between 16 and 24\xa0years old with severe aggression problems']","['Responsive Aggression Regulation Therapy (Re-ART', 'intervention Responsive Aggression Regulation Therapy (Re-ART', 'Re-ART Outpatient (n\xa0=\xa047) with a control group (n\xa0=\xa029) receiving treatment as usual on measures regarding risk of violent recidivism, impulsivity, emotional/personal functioning, family functioning, motivation, handling anger, self-reported problem behavior, coping skills, and cognitive distortions', 'Re-ART']","['Family functioning and self-reported rule-breaking behavior', 'risk of violent recidivism, impulsivity, emotional/personal functioning, motivation, handling anger, certain coping skills, and certain cognitive distortions']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}]",47.0,0.0299601,"Re-ART showed significantly better results than the control group on risk of violent recidivism, impulsivity, emotional/personal functioning, motivation, handling anger, certain coping skills, and certain cognitive distortions.","[{'ForeName': 'Larissa M', 'Initials': 'LM', 'LastName': 'Hoogsteder', 'Affiliation': 'Forensic Care Specialists, Forensic outpatient treatment center de Waag, Utrecht, The Netherlands.'}, {'ForeName': 'Eveline E', 'Initials': 'EE', 'LastName': 'Schippers', 'Affiliation': 'Forensic Care Specialists, Forensic outpatient treatment center de Waag, Utrecht, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Sweers', 'Affiliation': 'Forensic Care Specialists, Forensic outpatient treatment center de Waag, Utrecht, The Netherlands.'}, {'ForeName': 'Geert Jan J M', 'Initials': 'GJJM', 'LastName': 'Stams', 'Affiliation': 'Program Group: Forensic Child and Youth Care, University of Amsterdam, Amsterdam, The Netherlands.'}]",Journal of forensic sciences,['10.1111/1556-4029.14648']
2654,33275794,An improved algorithm using a Health Canada-approved DNA-image cytometry system for non-invasive screening of high-grade oral lesions.,"BACKGROUND
DNA-image cytometry (DNA-ICM) is able to detect gross alterations of cellular DNA-content representing aneuploidy, a biomarker of malignancy. A Health Canada-approved DNA-ICM system, ClearCyte® in combination with a cytopathologist's revie w have demonstrated high sensitivity (89%) and specificity (97%) in identifying high-grade oral lesions. The study objective was to create an improved automated algorithm (iClearcyte) and test its robustness in differentiating high-grade from benign reactive oral lesions without a cytopathologist's input.
METHODS
A set of 214 oral brushing samples of oral cancer (n=92), severe dysplasia (n=20), reactive lesions (n=52), and normal samples (n=50) were spun down onto slides and stained using Feulgen-Thionin reaction. Following ClearCyte® scan, nuclear features were calculated, and nuclei categorized into 'diploid', 'hyperdiploid', 'tetraploid', and 'aneuploid' DNA-ploidy groups by the ClearCyte® software. The samples were randomized into training and test sets (70:30) based on patient's age, sex, tobacco use and lesion site risk. The training set was used to create a new algorithm which was then validated using the remaining samples in the test set, where sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated.
RESULTS
The proposed iClearCyte algorithm (>1 'aneuploid' cell or ≥1.7% combined 'hyperdiploid' and 'tetraploid' nuclei frequency) identified high-grade samples with sensitivity, specificity, PPV and NPV of 100.0%, 86.7%, 89.7%, and 100.0%, respectively on the test set.
CONCLUSION
The iClearCyte test has potential to serve as a robust non-invasive automated oral cancer screening tool promoting early oral cancer detection and decreasing the number of unnecessary invasive biopsies.",2020,"combined 'hyperdiploid' and 'tetraploid' nuclei frequency) identified high-grade samples with sensitivity, specificity, PPV and NPV of 100.0%, 86.7%, 89.7%, and 100.0%, respectively on the test set.
","['214 oral brushing samples of oral cancer (n=92), severe dysplasia (n=20), reactive lesions (n=52), and normal samples (n=50) were spun down onto slides and stained using Feulgen-Thionin reaction']","['Health Canada-approved DNA-image cytometry system', 'iClearCyte algorithm']","['sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV']","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0334048', 'cui_str': 'Severe dysplasia'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0449895', 'cui_str': 'Stain used'}, {'cui': 'C0076494', 'cui_str': 'Thionin stain'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0282608', 'cui_str': 'Cytometry, Image'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",50.0,0.0461225,"combined 'hyperdiploid' and 'tetraploid' nuclei frequency) identified high-grade samples with sensitivity, specificity, PPV and NPV of 100.0%, 86.7%, 89.7%, and 100.0%, respectively on the test set.
","[{'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Parfenova', 'Affiliation': 'The University of British, Columbia Faculty of Dentistry, Oral Medical and Biological Sciences, BC Cancer Research Centre, Integrative Oncology.'}, {'ForeName': 'Kelly Y P', 'Initials': 'KYP', 'LastName': 'Liu', 'Affiliation': 'The University of British, Columbia Faculty of Dentistry, Oral Medical and Biological Sciences, Faculty of Dentistry, British Columbia Cancer Research Centre, Integrative Oncology.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Harrison', 'Affiliation': 'BC Cancer Research Centre.'}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'MacAulay', 'Affiliation': 'British Columbia Cancer Research Centre, Integrative Oncology.'}, {'ForeName': 'Martial', 'Initials': 'M', 'LastName': 'Guillaud', 'Affiliation': 'BC Cancer Research Centre, Cancer Imaging.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Poh', 'Affiliation': 'The University of British, Columbia Faculty of Dentistry; BC Cancer Research Centre.'}]",Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology,['10.1111/jop.13149']
2655,33275788,Food for mood: Experimentally induced negative affect triggers loss of control over eating in adolescents with low inhibitory control.,"OBJECTIVE
Loss of control over eating (LOC) is common among adolescents and is associated with negative developmental outcomes. Low self-regulation, and specifically low inhibitory control, is increasingly emphasized as an underlying factor in LOC. However, the specific context in which these capacities fail remains unclear. The affect regulation model proposes that negative affect may trigger LOC; however, research has mostly assessed trait negative affect using questionnaires, whereas measuring state negative affect is needed to determine its triggering role. Therefore, this study examined the interaction between inhibitory control and state negative affect in predicting LOC among adolescents using an experimental mood-induction design.
METHOD
Participants were 50 adolescents (10-18 years; 76% girls) from the general community. Participants first reported on their self-regulatory and inhibitory control capacities. They were then assigned to a sad or neutral mood-induction (using a film clip), followed by a multi-item food buffet from which they could eat as much as they liked. Finally, participants reported on their experience of loss of control while eating.
RESULTS
Inhibitory control (but not self-regulation in general) interacted with the mood-induction to predict LOC. Adolescents with low inhibitory control experienced significantly more LOC, but only in the sad mood condition.
DISCUSSION
The experience of negative affect appears to be an important trigger for LOC in adolescents with low inhibitory control. With a view to prevention and early intervention of LOC, inhibitory control training may be most effective in contexts where adolescents experience high levels of negative affect.",2020,"Adolescents with low inhibitory control experienced significantly more LOC, but only in the sad mood condition.
","['Participants were 50 adolescents (10-18\u2009years; 76% girls) from the general community', 'adolescents with low inhibitory control']","['LOC, inhibitory control training', 'sad or neutral mood-induction (using a film clip']",['LOC'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020505', 'cui_str': 'Overeating'}]",,0.018854,"Adolescents with low inhibitory control experienced significantly more LOC, but only in the sad mood condition.
","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Van Malderen', 'Affiliation': 'Department of Developmental, Personality and Social Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kemps', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Verbeken', 'Affiliation': 'Department of Developmental, Personality and Social Psychology, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Developmental, Personality and Social Psychology, Ghent University, Ghent, Belgium.'}]",The International journal of eating disorders,['10.1002/eat.23422']
2656,33275787,The Reciprocal Relationship between Depression and Disability in Low-Income Homebound Older Adults Following Tele-Depression Treatment.,"OBJECTIVES
Research has shown ample evidence for reciprocity between depression and disability. We examined whether decrease in disability among low-income, homebound older adults who received brief depression treatments were mediated by improvement in depressive symptoms and vice versa and whether the mediation effects varied by treatment modality.
METHODS
In a 3-arm randomized clinical trial, 277 low-income homebound individuals aged 50+ participated in behavioral activation tele-delivered by bachelor's-level lay counselors (Tele-BA), problem-solving therapy tele-delivered by licensed clinicians (Tele-PST), or telephone support calls (attention control). Depressive symptoms were assessed with the 24-item Hamilton Rating Scale for Depression and disability with the 12-item World Health Organization Disability Schedule 2.0. Along with mediation models, mediation was assessed controlling for autoregressive and contemporaneous effects.
RESULTS
Mediation models showed evidence of post-intervention disability and depression mediating each other in separate mediation models. In the cross-lagged model, in which autoregressive and contemporaneous effects were included, only the depression-to-disability path exhibited mediation. There was no evidence of difference between Tele-BA and Tele-PST. Although the temporal precedence of treatment conditions on the outcomes is apparent, we could not establish a temporal precedence between disability and depression as these two measures exhibited parallel improvement.
CONCLUSIONS
Brief depression treatments for low-income homebound older adults were effective in reducing both depression and disability among these disabled older adults. The importance of this study lies in the comparable effects of Tele-BA and Tele-PST. Lay-counselor model is a promising alternative to clinician-delivered psychotherapy for growing numbers of homebound older adults. This article is protected by copyright. All rights reserved.",2020,There was no evidence of difference between Tele-BA and Tele-PST.,"['277 low-income homebound individuals aged 50+ participated in', 'disabled older adults', 'low-income homebound older adults', 'homebound older adults']","[""behavioral activation tele-delivered by bachelor's-level lay counselors (Tele-BA), problem-solving therapy tele-delivered by licensed clinicians (Tele-PST), or telephone support calls (attention control"", 'Tele-BA and Tele-PST']","['disability', 'Depressive symptoms', '24-item Hamilton Rating Scale for Depression and disability with the 12-item World Health Organization Disability Schedule 2.0']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0242798', 'cui_str': 'Home-Bound Persons'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1515258', 'cui_str': 'Telephone number (property)'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]",277.0,0.0550645,There was no evidence of difference between Tele-BA and Tele-PST.,"[{'ForeName': 'C Nathan', 'Initials': 'CN', 'LastName': 'Marti', 'Affiliation': 'The University of Texas at Austin Steve Hicks School of Social Work.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': 'Houston VA HSR&D Center for Innovations in Quality, Effectiveness and Safety, Michael E. Debakey VA Medical Center, Education and Clinical Center, &Baylor College of Medicine, Houston, TX, VA South Central Mental Illness Research, Houston, TX.'}, {'ForeName': 'Namkee G', 'Initials': 'NG', 'LastName': 'Choi', 'Affiliation': 'The University of Texas at Austin Steve Hicks School of Social Work.'}]",International journal of geriatric psychiatry,['10.1002/gps.5480']
2657,33275775,Effects of selenium supplementation on pregnancy outcomes and disease progression in HIV-infected pregnant women in Lagos: A randomised controlled trial.,"OBJECTIVE
To examine the effects of selenium supplementation on pregnancy outcomes and disease progression among HIV-infected pregnant women in Lagos.
METHODS
A randomized, placebo-controlled trial conducted among HIV-positive pregnant women between September 2018 and August 2019. At enrolment, 90 women were randomly assigned into each treatment arm to receive either a daily tablet of 200μg elemental selenium or a placebo. Relevant participants' sociodemographic and clinical data were collected at enrolment and delivery.
RESULTS
Women in the selenium arm had a significantly lower risk of preterm delivery (relative risk, 0.32; 95 percent confidence interval, 0.11 to 0.96) and a non-significant reduction in the risk of delivering term neonates with a low delivery weight (relative risk, 0.24; 95 percent confidence interval, 0.05 to 1.19). Supplemental selenium does not increase the risk of perinatal death and adverse drug events.
CONCLUSION
The study reported a beneficial effect of antenatal selenium supplements on the risk of preterm delivery with no further reduction in risk among HIV-infected women who used the supplements for more than 14 weeks duration.",2020,"RESULTS
Women in the selenium arm had a significantly lower risk of preterm delivery (relative risk, 0.32; 95 percent confidence interval, 0.11 to 0.96) and a non-significant reduction in the risk of delivering term neonates with a low delivery weight (relative risk, 0.24; 95 percent confidence interval, 0.05 to 1.19).","['HIV-positive pregnant women between September 2018 and August 2019', '90 women', 'HIV-infected women who used the supplements for more than 14 weeks duration', 'HIV-infected pregnant women in Lagos']","['Supplemental selenium', 'placebo', 'antenatal selenium supplements', 'selenium supplementation', 'daily tablet of 200μg elemental selenium or a placebo']","['risk of preterm delivery', 'pregnancy outcomes and disease progression', 'risk of delivering term neonates with a low delivery weight', 'risk of perinatal death and adverse drug events']","[{'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]","[{'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0521939', 'cui_str': 'Selenium supplement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}]",90.0,0.595425,"RESULTS
Women in the selenium arm had a significantly lower risk of preterm delivery (relative risk, 0.32; 95 percent confidence interval, 0.11 to 0.96) and a non-significant reduction in the risk of delivering term neonates with a low delivery weight (relative risk, 0.24; 95 percent confidence interval, 0.05 to 1.19).","[{'ForeName': 'Kehinde S', 'Initials': 'KS', 'LastName': 'Okunade', 'Affiliation': 'Department of Obstetrics & Gynaecology, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Olusola F', 'Initials': 'OF', 'LastName': 'Olowoselu', 'Affiliation': 'Department of Haematology & Blood Transfusion College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'John-Olabode', 'Affiliation': 'Department of Haematology & Blood Transfusion College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Basirat O', 'Initials': 'BO', 'LastName': 'Hassan', 'Affiliation': 'AIDS Prevention Initiative in Nigeria (APIN) clinic, Lagos University Teaching Hospital, Lagos, Nigeria.'}, {'ForeName': 'Oluwatosin J', 'Initials': 'OJ', 'LastName': 'Akinsola', 'Affiliation': 'Department of Community Health & Primary Health Care, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Chidinma M', 'Initials': 'CM', 'LastName': 'Nwogu', 'Affiliation': 'Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria.'}, {'ForeName': 'Aloy O', 'Initials': 'AO', 'LastName': 'Ugwu', 'Affiliation': 'Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria.'}, {'ForeName': 'Olusanjo E', 'Initials': 'OE', 'LastName': 'Moses', 'Affiliation': 'Department of Obstetrics & Gynaecology, Lagos State University Teaching Hospital, Ikeja, Nigeria.'}, {'ForeName': 'Kabiru A', 'Initials': 'KA', 'LastName': 'Rabiu', 'Affiliation': 'Department of Obstetrics & Gynaecology, Lagos State University Teaching Hospital, Ikeja, Nigeria.'}, {'ForeName': 'Adegbenga', 'Initials': 'A', 'LastName': 'Ajepe', 'Affiliation': 'Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria.'}, {'ForeName': 'Muisi A', 'Initials': 'MA', 'LastName': 'Adenekan', 'Affiliation': 'Department of Obstetrics & Gynaecology, Lagos University Teaching Hospital, Lagos, Nigeria.'}, {'ForeName': 'Adebola A', 'Initials': 'AA', 'LastName': 'Adejimi', 'Affiliation': 'Department of Community Health & Primary Health Care, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Sulaimon A', 'Initials': 'SA', 'LastName': 'Akanmu', 'Affiliation': 'Department of Haematology & Blood Transfusion College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Phyllis J', 'Initials': 'PJ', 'LastName': 'Kanki', 'Affiliation': 'Department of Immunology & Infectious Diseases, Harvard School of Public Health, Boston, Massachusetts, USA.'}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,['10.1002/ijgo.13514']
2658,33275769,Prolonged rituximab maintenance in follicular lymphoma patients: long-term results of the SAKK 35/03 randomized trial.,"The Swiss Group for Clinical Cancer Research (SAKK) conducted the SAKK 35/03 randomized trial (NCT00227695) to investigate different rituximab monotherapy schedules in patients with follicular lymphoma (FL). Here, we report their long-term treatment outcome. Two-hundred and seventy FL patients were treated with 4 weekly doses of rituximab monotherapy (375 mg/m2); 165 of them, achieving at least a partial response, were randomly assigned to maintenance rituximab (375 mg/m2 every 2 months) on a short-term (4 administrations; n = 82) or a long-term (up to a maximum of 5 years; n = 83) schedule. The primary end point was event-free survival (EFS). At a median follow-up period of 10 years, median EFS was 3.4 years (95% confidence interval [CI], 2.1-5.5) in the short-term arm and 5.3 years (95% CI, 3.5-7.5) in the long-term arm. Using the prespecified log-rank test, this difference is not statistically significant (P = .39). There also was not a statistically significant difference in progression-free survival or overall survival (OS). Median OS was 11.0 years (95% CI, 11.0-NA) in the short-term arm and was not reached in the long-term arm (P = .80). The incidence of second cancers was similar in the 2 arms (9 patients after short-term maintenance and 10 patients after long-term maintenance). No major late toxicities emerged. No significant benefit of prolonged maintenance became evident with longer follow-up. Notably, in symptomatic patients in need of immediate treatment, the 10-year OS rate was 83% (95% CI, 73-89%). These findings indicate that single-agent rituximab may be a valid first-line option for symptomatic patients with advanced FL.",2020,"Median OS was 11.0 years (95% CI, 11.0-NA) in the short-term arm and was not reached in the long-term arm (P = .80).","['375 mg/m2); 165 of them, achieving at least a partial response', 'Two-hundred and seventy FL patients', 'symptomatic patients with advanced FL', 'follicular lymphoma patients', 'patients with follicular lymphoma (FL']","['maintenance rituximab', 'rituximab maintenance', 'rituximab monotherapy']","['10-year OS rate', 'Median OS', 'progression-free survival or overall survival (OS', 'event-free survival (EFS', 'incidence of second cancers', 'median EFS']","[{'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0751623', 'cui_str': 'Second primary malignancy'}]",270.0,0.159056,"Median OS was 11.0 years (95% CI, 11.0-NA) in the short-term arm and was not reached in the long-term arm (P = .80).","[{'ForeName': 'Alden A', 'Initials': 'AA', 'LastName': 'Moccia', 'Affiliation': 'Oncology Institute of Southern Switzerland, Medical Oncology Clinic, Ospedale San Giovanni, Bellinzona, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Taverna', 'Affiliation': 'Medical Oncology, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.'}, {'ForeName': 'Sämi', 'Initials': 'S', 'LastName': 'Schär', 'Affiliation': 'Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Vanazzi', 'Affiliation': 'Istituto Europeo di Oncologia, European Institute of Oncology Istituti di Ricovero e Cura a Carattere Scientifico, Milan, Italy.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rondeau', 'Affiliation': 'Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Hitz', 'Affiliation': 'Kantonsspital Saint Gallen, Saint Gallen, Switzerland.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Mingrone', 'Affiliation': 'Kantonsspital Olten, Olten, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lidija', 'Initials': 'L', 'LastName': 'Cevreska', 'Affiliation': 'University Clinic for Hematology, Skopje, Macedonia.'}, {'ForeName': 'Auro', 'Initials': 'A', 'LastName': 'Del Giglio', 'Affiliation': 'Hematology and Oncology, ABC Fondation School of Medicine, Sao Paulo, Brazil.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Raats', 'Affiliation': 'CancerCare Rondebosch, Cape Town, South Africa.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rauch', 'Affiliation': 'Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Vorobiof', 'Affiliation': 'Institute Sandton Oncology Center, Johannesburg, South Africa.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Lohri', 'Affiliation': 'Department of Oncology/Hematology, Kantonsspital Baselland, Liestal, Switzerland; and.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Ruegsegger', 'Affiliation': 'Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Biaggi Rudolf', 'Affiliation': 'Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Rusterholz', 'Affiliation': 'Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hayoz', 'Affiliation': 'Swiss Group for Clinical Cancer Research Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ghielmini', 'Affiliation': 'Oncology Institute of Southern Switzerland, Medical Oncology Clinic, Ospedale San Giovanni, Bellinzona, Switzerland.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Zucca', 'Affiliation': 'Oncology Institute of Southern Switzerland, Medical Oncology Clinic, Ospedale San Giovanni, Bellinzona, Switzerland.'}]",Blood advances,['10.1182/bloodadvances.2020002858']
2659,33275751,Global look at nutritional and functional iron deficiency in infancy.,"Iron-deficiency anemia (IDA) affects many infants in low- and middle-income countries (LMICs) and may impair cognitive development and adaptive immunity. Effective interventions to improve iron intakes for infants in LMICs are urgently needed. However, absorption of oral iron fortificants and supplements is low, usually <10%, and most of the iron passes into the colon unabsorbed. In randomized controlled trials, provision of iron to infants in LMICs adversely affects their gut microbiome and increases pathogenic Escherichia coli, gut inflammation, and diarrhea. To minimize these detrimental effects of iron, it is important to provide the lowest effective dosage and maximize fractional iron absorption. Prebiotic galacto-oligosaccharides and apo-lactoferrin may prove useful in iron formulations in LMICs because they increase absorption of fortificant iron and at the same time may mitigate the adverse effects of unabsorbed iron on the infant gut. Providing well-absorbed iron early in infancy may improve immune function. Recent data from a Kenyan birth cohort suggest IDA at the time of infant vaccination impairs the response to diphtheria, pertussis, and pneumococcus vaccines. A randomized trial follow-up study reported that providing iron to Kenyan infants at the time of measles vaccination increased antimeasles immunoglobulin G (IgG), seroconversion, and IgG avidity. Because IDA is so common among infants in LMICs and because the vaccine-preventable disease burden is so high, even if IDA only modestly reduces immunogenicity of vaccines, its prevention could have major benefits.",2020,"In randomized controlled trials, provision of iron to infants in LMICs adversely affects their gut microbiome and increases pathogenic Escherichia coli, gut inflammation, and diarrhea.",['infancy'],['Prebiotic galacto-oligosaccharides and apo-lactoferrin'],"['antimeasles immunoglobulin G (IgG), seroconversion, and IgG avidity', 'pathogenic Escherichia coli, gut inflammation, and diarrhea']","[{'cui': 'C0231330', 'cui_str': 'Infancy'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.191445,"In randomized controlled trials, provision of iron to infants in LMICs adversely affects their gut microbiome and increases pathogenic Escherichia coli, gut inflammation, and diarrhea.","[{'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Zimmermann', 'Affiliation': 'Swiss Federal Institute of Technology (ETH), Zurich, Switzerland.'}]",Hematology. American Society of Hematology. Education Program,['10.1182/hematology.2020000131']
2660,33275544,Analgesic Effect of Alcohol Mediates the Association between Alcohol Intoxication and Deliberate Self-Harm.,"We examined whether the analgesic effect of alcohol mediates the association between alcohol and deliberate self-harm (DSH) using data from a larger study on alcohol effects. Men ( n = 106) and women ( n = 104) low-risk alcohol drinkers (ages M = 26.00, SD = 6.98) recruited from the community who had no suicide attempt or episode of deliberate self-harm within the past year were randomly assigned to either a placebo drink condition or a drink calibrated to reach approximately .050%, .075%, or .100% blood alcohol concentration. Notable within-condition BAC variability, as well as overlap between conditions, suggested that BAC would be a more accurate indicator of intoxication compared to condition assignment. Pain tolerance was assessed by increasingly intense 1-s shocks delivered via fingertip electrodes. Self-reported pain associated with the pain tolerance index was also examined. A laboratory task of DSH, the Self-Aggression Paradigm, was then completed, with DSH operationalized as the number of self-administered shocks the participant was led to believe were twice the intensity of his or her pain tolerance and could cause ""minor tissue damage that would quickly heal."" A negative binomial parallel mediational model for count data revealed that pain tolerance, but not self-report pain, mediated the effect of alcohol on DSH. As such, the current study provides preliminary experimental evidence that the analgesic effect of alcohol is partially responsible for link between alcohol intoxication and deliberate self-harm.",2020,We examined whether the analgesic effect of alcohol mediates the association between alcohol and deliberate self-harm (DSH) using data from a larger study on alcohol effects.,"['Men ( n \u2009=\u2009106) and women ( n \u2009=\u2009104) low-risk alcohol drinkers (ages M \u2009=\u200926.00, SD \u2009=\u20096.98) recruited from the community who had no suicide attempt or episode of deliberate self-harm within the past year']","['Alcohol', 'placebo drink condition or a drink calibrated to reach approximately .050%, .075%, or .100% blood alcohol concentration']","['pain tolerance index', 'Pain tolerance']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0221134', 'cui_str': 'Blood group antigen M'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0036601', 'cui_str': 'Self-mutilation'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0217047,We examined whether the analgesic effect of alcohol mediates the association between alcohol and deliberate self-harm (DSH) using data from a larger study on alcohol effects.,"[{'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Amadi', 'Affiliation': ''}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Berman', 'Affiliation': ''}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Timmins', 'Affiliation': ''}, {'ForeName': 'Casey R', 'Initials': 'CR', 'LastName': 'Guillot', 'Affiliation': ''}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Fanning', 'Affiliation': ''}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Nadorff', 'Affiliation': ''}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'McCloskey', 'Affiliation': ''}]",Archives of suicide research : official journal of the International Academy for Suicide Research,['10.1080/13811118.2020.1851831']
2661,33275467,"Effects of Exercise on Resilience, Insight and Functionality in Patients with Chronic Schizophrenia in a Psychiatric Nursing Home Setting: A Randomized Controlled Trial.","To our knowledge, there are no studies on the effects of exercise in patients with severe schizophrenia-related disability or in nursing home settings. Again, the literature search on the influence of exercise on insight and resilience gives no results except mind-body exercises. The aim of this study was to investigate the effects of exercise on psychotic symptoms, depression, functionality, insight and resilience in patients with severe schizophrenia-related disability living in nursing home setting. Thirty-nine patients with schizophrenia were recruited. Exercise group with 20 patients who continued resistance exercise for 60 min, 2 days a week, for 3 months; and treatment as usual (TAU) group with 19 patients. All patients were administered Scale for the Assessment of Positive Symptoms, Scale for the Assessment of Negative Symptoms (SANS), Calgary Depression Scale for Schizophrenia (CDSS), Schedule for Assessment of Insight (SAI), Functional Remission of General Schizophrenia Scale (FROGS), Resilience Scale for Adults (RSA) at baseline and 3 months after. There were no significant differences between the groups for baseline and third month scores. In both groups significant decrease in SANS scores, significant increase in scores of FROGS total and social functioning, daily life skills subscale and RSA perception of the self were observed. In exercise group, significant decrease in CDSS scores, and significant increase in SAI awareness of illness, FROGS health and treatment, occupational functioning scores were found. Exercise combined with TAU may be effective in increasing awareness of illness and alleviating depression in chronic schizophrenia.",2020,"In both groups significant decrease in SANS scores, significant increase in scores of FROGS total and social functioning, daily life skills subscale and RSA perception of the self were observed.","['Patients with Chronic Schizophrenia in a Psychiatric Nursing Home Setting', 'patients with severe schizophrenia-related disability living in nursing home setting', 'Thirty-nine patients with schizophrenia were recruited', 'group with 20 patients who', 'patients with severe schizophrenia-related disability or in nursing home settings']","['Exercise combined with TAU', 'Exercise', 'continued resistance exercise', 'exercise']","['psychotic symptoms, depression, functionality, insight and resilience', 'SANS scores', 'Resilience, Insight and Functionality', 'SAI awareness of illness, FROGS health and treatment, occupational functioning scores', 'scores of FROGS total and social functioning, daily life skills subscale and RSA perception of the self', 'Positive Symptoms, Scale for the Assessment of Negative Symptoms (SANS), Calgary Depression Scale for Schizophrenia (CDSS), Schedule for Assessment of Insight (SAI), Functional Remission of General Schizophrenia Scale (FROGS), Resilience Scale for Adults (RSA', 'CDSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",39.0,0.0454091,"In both groups significant decrease in SANS scores, significant increase in scores of FROGS total and social functioning, daily life skills subscale and RSA perception of the self were observed.","[{'ForeName': 'Güliz', 'Initials': 'G', 'LastName': 'Şenormancı', 'Affiliation': 'Department of Psychiatry, University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Turkey.'}, {'ForeName': 'Nimet', 'Initials': 'N', 'LastName': 'Korkmaz', 'Affiliation': 'Faculty of Sport Sciences Physical Education and Sports Teaching Department, Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Ömer', 'Initials': 'Ö', 'LastName': 'Şenormancı', 'Affiliation': 'Department of Psychiatry, University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Turkey.'}, {'ForeName': 'Selen', 'Initials': 'S', 'LastName': 'Uğur', 'Affiliation': 'Faculty of Sport Sciences Physical Education and Sports Teaching Department, Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Mine', 'Initials': 'M', 'LastName': 'Topsaç', 'Affiliation': 'Faculty of Sport Sciences Physical Education and Sports Teaching Department, Uludağ University, Bursa, Turkey.'}, {'ForeName': 'Okan', 'Initials': 'O', 'LastName': 'Gültekin', 'Affiliation': 'Faculty of Sport Sciences Physical Education and Sports Teaching Department, Uludağ University, Bursa, Turkey.'}]",Issues in mental health nursing,['10.1080/01612840.2020.1847221']
2662,33278747,Pentoxifylline decreases serum LDH levels and increases lymphocyte count in COVID-19 patients: Results from an external pilot study.,"We have previously hypothesized that pentoxifylline could be beneficial for the treatment of COVID-19 given its potential to restore the immune response equilibrium, reduce the impact of the disease on the endothelium and alveolar epithelial cells, and improve the circulatory function.Serum lactate dehydrogenase (LDH) and lymphocyte count are accessible biomarkers that correlate with the severity of COVID-19, the need for hospitalization, and mortality, reflecting the host immune response's contribution to the seriousness of SARS-CoV-2 infection. We carried out this external pilot study on 38 patients with moderate and severe COVID-19 to test the effect pentoxifylline on parameters such as LDH, lymphocyte count, days of hospitalization, mortality, and proportion of patients requiring intubation. Twenty-six patients were randomized to receive 400 mg of pentoxifylline t.i.d. plus standard therapy (pentoxifylline group), while the rest received the standard treatment (control group). Linear regression models were built for statistically significant parameters. Pentoxifylline treatment was associated with a 64.25% increase (CI95% 11.83, 116.68) in lymphocyte count and a 29.61% decrease (CI95% 15.11, 44.10) in serum LDH. Although a trend towards reduced days of hospitalization, mortality, and proportion of patients requiring intubation was observed, no statistically significant difference was found for these parameters. Our findings open the possibility of pentoxifylline being repositioned as a drug for COVID-19 treatment with the advantages of a proven safety profile, availability, and no risk of immunosuppression; however, this evidence needs to be confirmed in a pragmatic randomized controlled trial.",2020,"Pentoxifylline treatment was associated with a 64.25% increase (CI95% 11.83, 116.68) in lymphocyte count and a 29.61% decrease (CI95% 15.11, 44.10) in serum LDH.","['38 patients with moderate and severe COVID-19 to test the effect', 'COVID-19 patients', 'Twenty-six patients']","['pentoxifylline t.i.d. plus standard therapy (pentoxifylline', 'Pentoxifylline', 'pentoxifylline']","['hospitalization, mortality, and proportion of patients requiring intubation', 'serum LDH levels', 'LDH, lymphocyte count, days of hospitalization, mortality, and proportion of patients requiring intubation', 'lymphocyte count', 'Serum lactate dehydrogenase (LDH) and lymphocyte count']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1278052', 'cui_str': 'Serum lactate dehydrogenase measurement'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}]",38.0,0.0777496,"Pentoxifylline treatment was associated with a 64.25% increase (CI95% 11.83, 116.68) in lymphocyte count and a 29.61% decrease (CI95% 15.11, 44.10) in serum LDH.","[{'ForeName': 'Valente', 'Initials': 'V', 'LastName': 'Maldonado', 'Affiliation': 'Faculty of Chemical Sciences, Universidad La Salle-México, Cuauhtémoc, Mexico City 06140, Mexico; Department of Allergy and Clinical Immunology Internal Medicine, General Hospital of Zone 27 Mexican Institute of Social Security, Lerdo 311, Nonoalco Tlatelolco, Cuauhtémoc, Mexico City 6390, Mexico. Electronic address: valentemaldonado@lasallistas.org.mx.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Hernandez-Ramírez', 'Affiliation': 'Department of Allergy and Clinical Immunology Internal Medicine, General Hospital of Zone 27 Mexican Institute of Social Security, Lerdo 311, Nonoalco Tlatelolco, Cuauhtémoc, Mexico City 6390, Mexico.'}, {'ForeName': 'Eniel Alonso', 'Initials': 'EA', 'LastName': 'Oliva-Pérez', 'Affiliation': 'Department of Internal Medicine, General Hospital of Zone 27 Mexican Institute of Social Security, Nonoalco Tlatelolco, Cuauhtémoc, Mexico City 6390, Mexico.'}, {'ForeName': 'César Omar', 'Initials': 'CO', 'LastName': 'Sánchez-Martínez', 'Affiliation': 'Department of Internal Medicine, General Hospital of Zone 27 Mexican Institute of Social Security, Nonoalco Tlatelolco, Cuauhtémoc, Mexico City 6390, Mexico.'}, {'ForeName': 'Jorge Fabián', 'Initials': 'JF', 'LastName': 'Pimentel-González', 'Affiliation': 'Department of Internal Medicine, General Hospital of Zone 27 Mexican Institute of Social Security, Nonoalco Tlatelolco, Cuauhtémoc, Mexico City 6390, Mexico.'}, {'ForeName': 'José Raúl', 'Initials': 'JR', 'LastName': 'Molina-Sánchez', 'Affiliation': 'Department of Internal Medicine, General Hospital of Zone 27 Mexican Institute of Social Security, Nonoalco Tlatelolco, Cuauhtémoc, Mexico City 6390, Mexico.'}, {'ForeName': 'Yeimmy Zuyenn', 'Initials': 'YZ', 'LastName': 'Jiménez-Villalba', 'Affiliation': 'Department of Internal Medicine, General Hospital of Zone 27 Mexican Institute of Social Security, Nonoalco Tlatelolco, Cuauhtémoc, Mexico City 6390, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Chávez-Alderete', 'Affiliation': 'Department of Bronchial Hyperreactivity, National Institute of Respiratory Diseases Ismael Cosío Villegas, Tlalpan, Mexico City 14080, Mexico.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Loza-Mejía', 'Affiliation': 'Faculty of Chemical Sciences, Universidad La Salle-México, Cuauhtémoc, Mexico City 06140, Mexico.'}]",International immunopharmacology,['10.1016/j.intimp.2020.107209']
2663,33278743,Using Artificial Intelligence to Predict Change in Depression and Anxiety Symptoms in a Digital Intervention: Evidence from a Transdiagnostic Randomized Controlled Trial.,"While digital psychiatric interventions reduce treatment barriers, not all persons benefit from this type of treatment. Research is needed to preemptively identify who is likely to benefit from these digital treatments in order to redirect those people to a higher level of care. The current manuscript used an ensemble of machine learning methods to predict changes in major depressive and generalized anxiety disorder symptoms from pre to 9-month follow-up in a randomized controlled trial of a transdiagnostic digital intervention based on participants' (N=632) pre-treatment data. The results suggested that baseline characteristics could accurately predict changes in depressive symptoms in both treatment groups (r=0.482, 95% CI[0.394, 0.561]; r=0.477, 95% CI[0.385, 0.560]) and anxiety symptoms in both treatment groups (r=0.569, 95% CI[0.491, 0.638]; r=0.548, 95% CI[0.464, 0.622]). These results suggest that machine learning models are capable of preemptively predicting a person's responsiveness to digital treatments, which would enable personalized decision-making about which persons should be directed towards standalone digital interventions or towards blended stepped-care.",2020,"The results suggested that baseline characteristics could accurately predict changes in depressive symptoms in both treatment groups (r=0.482, 95% CI[0.394, 0.561]; r=0.477, 95% CI[0.385, 0.560]) and anxiety symptoms in both treatment groups (r=0.569, 95% CI[0.491, 0.638]; r=0.548, 95% CI[0.464, 0.622]).",[],"['machine learning methods', 'transdiagnostic digital intervention']","['major depressive and generalized anxiety disorder symptoms', 'depressive symptoms', 'Depression and Anxiety Symptoms', 'anxiety symptoms']",[],"[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0851406', 'cui_str': 'Anxiety disorders and symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.203508,"The results suggested that baseline characteristics could accurately predict changes in depressive symptoms in both treatment groups (r=0.482, 95% CI[0.394, 0.561]; r=0.477, 95% CI[0.385, 0.560]) and anxiety symptoms in both treatment groups (r=0.569, 95% CI[0.491, 0.638]; r=0.548, 95% CI[0.464, 0.622]).","[{'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Jacobson', 'Affiliation': 'Dartmouth College. Electronic address: Nicholas.C.Jacobson@dartmouth.edu.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Nemesure', 'Affiliation': 'Dartmouth College.'}]",Psychiatry research,['10.1016/j.psychres.2020.113618']
2664,33278717,Implementation of a cluster randomized controlled trial: Identifying student peer leaders to lead E-cigarette interventions.,"E-cigarette use has been increasing among middle school students. Intervention programs to prevent e-cigarette initiation administered by authority figures are met with more resistance from youth compared to peer-led programs. Therefore, this study aimed to assess the feasibility, acceptability, and implementation process of using social network analysis (SNA) to identify student peer leaders in schools and train them to deliver e-cigarette prevention programming to their peers. Nine schools were recruited to participate in the study during the 2019-2020 school year. Schools were assigned to one of three conditions: (1) expert; (2) peer-random (selected peer-leaders would teach to random students); and (3) peer-fixed (selected peer-leaders would teach to assigned students based on nominations). Study participation varied by day due to school attendance, with 686 participants at baseline and 608 at posttest. Almost all students who did not complete the study resulted from the interruption of schools being closed due to COVID-19. Implementation issues fell into three categories: (1) scheduling, (2) day-of logistics, and (3) student group dynamics. Overall, the results showed positive satisfaction among teachers, who unanimously found the program appropriate for the grade-level and that peer-leaders worked well within their groups. Peer-led students-both random and assigned-reported having more fun and willing to tell friends to try the program compared to expert-led students. This study demonstrated the feasibility of implementing a peer-led e-cigarette prevention program for 6th grade students, using SNA to provide intervention rigidity and validity.",2020,Peer-led students-both random and assigned-reported having more fun and willing to tell friends to try the program compared to expert-led students.,"['middle school students', 'student peer leaders in schools and train them to deliver e-cigarette prevention programming to their peers', 'Nine schools were recruited to participate in the study during the 2019-2020 school year', '686 participants at baseline and 608 at posttest']","['peer-random (selected peer-leaders would teach to random students); and (3) peer-fixed (selected peer-leaders would teach to assigned students based on nominations', 'student peer leaders to lead E-cigarette interventions', 'social network analysis (SNA', 'implementing a peer-led e-cigarette prevention program']",[],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1171218', 'cui_str': 'Social network analysis'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],9.0,0.0172633,Peer-led students-both random and assigned-reported having more fun and willing to tell friends to try the program compared to expert-led students.,"[{'ForeName': 'Kar-Hai', 'Initials': 'KH', 'LastName': 'Chu', 'Affiliation': 'University of Pittsburgh, United States. Electronic address: chuk@pitt.edu.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sidani', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Matheny', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rothenberger', 'Affiliation': 'University of Pittsburgh, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""UPMC Children's Hospital, United States.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Valente', 'Affiliation': 'University of Southern California, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Robertson', 'Affiliation': 'UPMC Hillman Cancer Center, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106726']
2665,33278671,Randomized phase II study of platinum-based chemotherapy plus controlled diet with or without metformin in patients with advanced non-small cell lung cancer.,"OBJECTIVES
Accumulating evidence indicates anti-diabetic drug metformin has anti-cancer effect by controlling cancer metabolism. We evaluated whether addition of metformin to chemotherapy improved survival of lung cancer patients.
MATERIALS AND METHODS
This randomized phase II study enrolled 164 patients with chemo-native, EGFR-ALK wild-type, stage IIIB/IV non-small-cell lung cancer (NSCLC). Patients were randomized to receive chemotherapy either with metformin (1000 mg twice daily) or alone every 3 weeks for six cycles. The patients received gemcitabine (1000 mg/m 2 ) on days 1 and 8 and carboplatin (5 area under the curve) on day 1. Exploratory studies included serum metabolic panels, positron-emission tomography (PET) imaging, and genetic mutation tests for metabolism-related genes.
RESULTS
Metformin group showed no significant difference in the risk of progression and death compared to control group (progression: hazard ratio [HR] = 1.01 [95% confidence interval (CI) = 0.72 - 1.42], P = 0.935; death: HR = 0.95 [95% CI = 0.67-1.34], P = 0.757). Squamous cell carcinoma (SqCC) had significantly higher fluorodeoxyglucose (FDG) uptake on baseline PET image than non-SqCC NSCLC (P = 0.004). In the SqCC with high FDG uptake, the addition of metformin significantly decreased the risk of progression and death (progression: HR = 0.31 [95% CI = 0.12-0.78], P = 0.013; death: HR = 0.42 [95% CI = 0.18-0.94], P = 0.035). The HDL-cholesterol level was significantly increased after the treatment in metformin group compared to control group (P = 0.011). The metformin group showed no survival benefit in the patients with hyperinsulinemia or patients whose insulin level was decreased after treatment.
CONCLUSIONS
Addition of metformin to chemotherapy provided no survival benefit in unselected NSCLC patients. However, it significantly improved the survival of the selected patients with SqCC showing high FDG uptake. It suggests metformin shows the synergistic anti-tumor effect in the tumor which are highly dependent on glucose metabolism.",2020,Squamous cell carcinoma (SqCC) had significantly higher fluorodeoxyglucose,"['unselected NSCLC patients', 'patients with advanced non-small cell lung cancer', 'lung cancer patients', 'Squamous cell carcinoma (SqCC', '164 patients with chemo-native, EGFR-ALK wild-type, stage IIIB/IV non-small-cell lung cancer (NSCLC']","['gemcitabine', 'chemotherapy either with metformin', 'Metformin', 'metformin', 'platinum-based chemotherapy plus controlled diet with or without metformin', 'fluorodeoxyglucose', 'carboplatin']","['serum metabolic panels, positron-emission tomography (PET) imaging, and genetic mutation tests', 'risk of progression and death', 'insulin level', 'survival', 'HDL-cholesterol level', 'survival benefit']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}]",164.0,0.0826342,Squamous cell carcinoma (SqCC) had significantly higher fluorodeoxyglucose,"[{'ForeName': 'Youngjoo', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Jungnam', 'Initials': 'J', 'LastName': 'Joo', 'Affiliation': 'Office of Biostatistics Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, USA.'}, {'ForeName': 'You Jin', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Sohyun', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Nuclear Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Sung', 'Initials': 'TS', 'LastName': 'Kim', 'Affiliation': 'Department of Nuclear Medicine, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Soo-Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'So Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Nutrition, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Gyung-Ah', 'Initials': 'GA', 'LastName': 'Wie', 'Affiliation': 'Department of Clinical Nutrition, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Minjoung', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Mi-Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': ""Division of Medical Oncology, Department of Internal Medicine, Catholic Kwandong University International St. Mary's Hospital, Incheon, Republic of Korea.""}, {'ForeName': 'Jin Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea. Electronic address: jymama@ncc.re.kr.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.11.011']
2666,33278625,A five day course of ivermectin for the treatment of COVID-19 may reduce the duration of illness.,"Ivermectin, an FDA-approved anti-parasitic agent, was found in vitro to inhibit SARS-CoV-2 replication. To determine the rapidity of viral clearance and safety of ivermectin among adult SARS-CoV-2 patients we conducted a randomized, double-blind, placebo-controlled trial of oral ivermectin alone (12 mg once daily for 5 days) or in combination with doxycycline (12 mg ivermectin single dose and 200 mg stat doxycycline day-1 followed by 100 mg 12hrly for next 4 days) compared with placebo among 72 hospitalized patients in Dhaka, Bangladesh. Clinical symptoms of fever, cough and sore throat were comparable among the three treatment arms. Virological clearance was earlier in the 5-day ivermectin treatment arm versus the placebo group (9.7 days vs. 12.7 days; P = 0.02); but not with the ivermectin + doxycycline arm (11.5 days; P = 0.27). There were no severe adverse drug events recorded in the study. A 5-day course of ivermectin was found to be safe and effective in treating mild COVID-19 adult patients. Larger trials will be needed to confirm these preliminary findings.",2020,A 5-day course of ivermectin was found to be safe and effective in treating mild COVID-19 adult patients.,"['mild COVID-19 adult patients', '72 hospitalized patients in Dhaka, Bangladesh', 'adult SARS-CoV-2 patients']","['ivermectin single dose and 200\u2009mg stat doxycycline', 'Ivermectin', 'placebo', 'doxycycline', 'oral ivermectin alone', 'ivermectin', 'ivermectin\u2009+\u2009doxycycline']","['duration of illness', 'severe adverse drug events', 'safe and effective', 'Virological clearance', 'Clinical symptoms of fever, cough and sore throat']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}]",72.0,0.478278,A 5-day course of ivermectin was found to be safe and effective in treating mild COVID-19 adult patients.,"[{'ForeName': 'Sabeena', 'Initials': 'S', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Mahbubul', 'Initials': 'MM', 'LastName': 'Karim', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Allen G', 'Initials': 'AG', 'LastName': 'Ross', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Sharif', 'Initials': 'MS', 'LastName': 'Hossain', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mariya Kibtiya', 'Initials': 'MK', 'LastName': 'Sumiya', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ching Swe', 'Initials': 'CS', 'LastName': 'Phru', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mustafizur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Somani', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, National University Hospital, Singapore.'}, {'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Yasmin', 'Affiliation': 'Mugda Medical College and Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad Abul', 'Initials': 'MA', 'LastName': 'Hasnat', 'Affiliation': 'Kurmitola General Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Ahmedul', 'Initials': 'A', 'LastName': 'Kabir', 'Affiliation': 'Dhaka Medical College & Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Asma Binte', 'Initials': 'AB', 'LastName': 'Aziz', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Wasif Ali', 'Initials': 'WA', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh. Electronic address: wakhan@icddrb.org.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.11.191']
2667,33278614,The findings of a surgical hip fracture trial were generalisable to the UK national hip fracture database.,"OBJECTIVE
To estimate the generalisability of treatment effects observed in a randomised trial of hip fracture surgery implants, to a broader population of people undergoing hip surgery in the United Kingdom.
STUDY DESIGN AND SETTING
In 2018, the WHiTE-3 trial (n=958) demonstrated that a modular hemiarthroplasty implant conferred no additional benefit over the traditional monoblock implant for quality of life and length of hospital stay. We compared and weighted the trial sample against two target populations: WHiTE-cohort (n=2,457) and UK-National Hip Fracture Database (NHFD, n=190,894), and re-estimate expected treatment effects for the target populations.
RESULTS
Despite differences in baseline characteristics of the trial sample and target populations, the re-estimated treatment effects were comparable. For quality of life, the differences between the trial estimate and WHiTE-cohort and NHFD estimates were 0.01 points on the EuroQol (EQ5D). For length of stay, the difference between the trial estimate and WHiTE-cohort was 0.50 days; and the difference between the trial estimate and NHFD estimate was -0.47 days.
CONCLUSION
This generalisability analysis of the WHiTE-3 trial found that the inferences from the trial can be generalised to the group of individuals in the UK NHFD and the WHiTE-cohort who met the inclusion criteria for WHiTE-3.",2020,"For quality of life, the differences between the trial estimate and WHiTE-cohort and NHFD estimates were 0.01 points on the EuroQol (EQ5D).","['people undergoing hip surgery in the United Kingdom', 'group of individuals in the UK NHFD and the WHiTE-cohort who met the inclusion criteria for WHiTE-3']","['modular hemiarthroplasty implant', 'hip fracture surgery implants']",['quality of life and length of hospital stay'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0744743', 'cui_str': 'Hemi-Arthroplasty'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.192004,"For quality of life, the differences between the trial estimate and WHiTE-cohort and NHFD estimates were 0.01 points on the EuroQol (EQ5D).","[{'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; School of Medicine and Public Health, University of Newcastle, Newcastle, Australia. Electronic address: hopin.lee@ndorms.ox.ac.uk.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Kadoorie Centre, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alex L', 'Initials': 'AL', 'LastName': 'Sims', 'Affiliation': 'Northumbria NHS Foundation Trust, Northumberland, UK.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Kadoorie Centre, John Radcliffe Hospital, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Xavier L', 'Initials': 'XL', 'LastName': 'Griffin', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Newark Street, London, UK; Barts Health NHS Trust, London, UK.'}]",Journal of clinical epidemiology,['10.1016/j.jclinepi.2020.11.016']
2668,33272643,"Efficacy and Safety of the Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule for Peripheral Neuropathic Pain: a Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial.","PURPOSE
This study compared the efficacy and safety of controlled-release pregabalin (GLA5PR GLARS-NF1 tablets) with those of an immediate-release pregabalin capsule after 12 weeks' administration to patients with peripheral neuropathic pain.
METHODS
In this multicenter, randomized, double-blind, active-controlled, parallel-group, Phase III study, the primary outcome was to confirm that a single treatment with the study drug (after the evening meal) is clinically noninferior to the control drug (BID regimen) at improving the mean Daily Pain Rating Scale score for treating peripheral neuropathic pain. Secondary outcomes were the Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, Hospital Anxiety and Depression scale, and frequency of rescue medication use. The safety and tolerability of GLA5PR GLARS-NF1 tablets were also evaluated. The total daily dose of pregabalin is 150-600 mg.
FINDINGS
Of the 352 randomized subjects, 261 (n = 130, study group; n = 131, control group) were analyzed. The difference in adjusted mean Daily Pain Rating Scale scores between the groups was -0.11 (95% confidence interval, -0.05 to 0.30), indicating that the study group is noninferior to the control group. There was no statistically significant difference in Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression scale scores between the groups at treatment termination. Logistic regression analysis revealed no significant difference in the use of rescue medication between the groups (P = 0.217). The overall adverse event profile of the groups was similar, and no serious adverse drug reactions were observed.
IMPLICATIONS
GLA5PR GLARS-NF1 tablets can be effectively and safely administered to patients with peripheral neuropathic pain. Furthermore, we found that sleep, anxiety, and depression were improved with pain control. Owing to the once-daily administration, treatment effects can be maximized by improved treatment compliance. ClinicalTrials.gov identifier: NCT03221907.",2020,"There was no statistically significant difference in Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression scale scores between the groups at treatment termination.","['patients with peripheral neuropathic pain', 'Peripheral Neuropathic Pain', '352 randomized subjects, 261 (n\xa0=\xa0130, study group; n\xa0']","['GLA5PR GLARS-NF1 tablets', 'controlled-release pregabalin (GLA5PR GLARS-NF1 tablets', 'GLARS-NF1 tablets', 'GLA5PR', 'pregabalin', 'Controlled-release Pregabalin Tablet (GLA5PR GLARS-NF1) and Immediate-release Pregabalin Capsule']","['Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, Hospital Anxiety and Depression scale, and frequency of rescue medication use', 'sleep, anxiety, and depression', 'safety and tolerability', 'adjusted mean Daily Pain Rating Scale scores', 'overall adverse event profile', 'mean Daily Pain Rating Scale score for treating peripheral neuropathic pain', 'efficacy and safety', 'Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression scale scores', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1660529', 'cui_str': 'pregabalin Oral Capsule'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0458960', 'cui_str': 'Peripheral neuropathic pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",352.0,0.180464,"There was no statistically significant difference in Daily Sleep Interference Scale, Medical Outcomes Study Sleep Scale, and Hospital Anxiety and Depression scale scores between the groups at treatment termination.","[{'ForeName': 'Min-Kyung', 'Initials': 'MK', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Younghoon', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Dentistry, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Sang Sik', 'Initials': 'SS', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Pyung Bok', 'Initials': 'PB', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Yong-Chul', 'Initials': 'YC', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong Hun', 'Initials': 'JH', 'LastName': 'Suh', 'Affiliation': 'Seoul Nanum Pain Clinic, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Sim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Catholic University, Seoul, Republic of Korea.'}, {'ForeName': 'Sun Ok', 'Initials': 'SO', 'LastName': 'Song', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Hyosan Hospital Songhyo Healthcare Foundation, Daegu, Republic of Korea.'}, {'ForeName': 'Youngkwon', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'Department of Anesthesia and Pain Medicine, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Jae Myung', 'Initials': 'JM', 'LastName': 'Yu', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Kyungwan', 'Initials': 'K', 'LastName': 'Min', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Nowon Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Hyuk', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Myongji Hospital, Hanyang University College of Medicine, Gyeonggi-do, Republic of Korea. Electronic address: jaehyugy93@naver.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.10.009']
2669,33272623,"Randomized, assessor-blind, antimüllerian hormone-stratified, dose-response trial in Japanese in vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta.","OBJECTIVE
To establish the relationship between follitropin delta doses (recombinant follicle-stimulating hormone produced from the human cell line PER.C6) and ovarian response in Japanese women undergoing in vitro fertilization/intracytoplasmic sperm injection treatment and to evaluate the influence of initial antimüllerian hormone (AMH) levels.
DESIGN
Randomized, controlled, assessor-blind, AMH-stratified (low 5.0-14.9 pmol/L; high 15.0-44.9 pmol/L) dose-response trial.
SETTING
Reproductive medicine clinics.
PATIENT(S)
A total of 158 Japanese women (20-39 years of age).
INTERVENTION(S)
Controlled ovarian stimulation with 6, 9, or 12 μg/d of follitropin delta or 150 IU/d follitropin beta as a reference arm in a gonadotropin-releasing hormone antagonist cycle.
MAIN OUTCOME MEASURE(S)
Number of oocytes retrieved.
RESULT(S)
Among all women who started stimulation, the mean number (± standard deviation) of oocytes retrieved in the 6 μg/d, 9 μg/d, and 12 μg/d follitropin delta groups was 7.0 ± 4.1, 9.1 ± 5.6, and 11.6 ± 5.6, respectively, and a significant dose-relation was established, which also remained significant within each AMH strata. Significant dose-responses also were observed for serum estradiol, inhibin A, and progesterone at end-of-stimulation with follitropin delta. The vital pregnancy rate per started cycle with follitropin delta was 19% for 6 μg/d, 20% for 9 μg/d, and 25% for 12 μg/d. The rate of early moderate/severe ovarian hyperstimulation syndrome with follitropin delta was 8% for 6 μg/d, 8% for 9 μg/d, and 13% for 12 μg/d, with 82% of the cases in the high AMH stratum.
CONCLUSION(S)
This trial establishes the dose-response relationship between follitropin delta and ovarian response in Japanese women.
CLINICAL TRIAL REGISTRATION NUMBER
NCT02309671.",2020,"Significant dose-responses also were observed for serum estradiol, inhibin A, and progesterone at end-of-stimulation with follitropin delta.","['Japanese women undergoing in\xa0vitro fertilization', '158 Japanese women (20-39 years of age', 'Reproductive medicine clinics', 'Japanese in\xa0vitro fertilization/intracytoplasmic sperm injection patients undergoing controlled ovarian stimulation with follitropin delta', 'Japanese women']","['intracytoplasmic sperm injection treatment', 'follitropin delta doses (recombinant follicle-stimulating hormone', 'follitropin delta or 150 IU/d follitropin beta as a reference arm in a gonadotropin-releasing hormone antagonist cycle']","['Number of oocytes retrieved', 'rate of early moderate/severe ovarian hyperstimulation syndrome with follitropin delta', 'serum estradiol, inhibin A, and progesterone', 'mean number (± standard deviation) of oocytes', 'vital pregnancy rate per started cycle with follitropin delta']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0242668', 'cui_str': 'Medicine, Reproductive'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C4301617', 'cui_str': 'follitropin delta'}]","[{'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0060787', 'cui_str': 'follitropin beta'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}]","[{'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0883157', 'cui_str': 'Inhibin A'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]",158.0,0.314391,"Significant dose-responses also were observed for serum estradiol, inhibin A, and progesterone at end-of-stimulation with follitropin delta.","[{'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ishihara', 'Affiliation': 'Department of Obstetrics and Gynecology, Saitama Medical University, Moroyama, Iruma-gun, Saitama, Japan.'}, {'ForeName': 'Bjarke M', 'Initials': 'BM', 'LastName': 'Klein', 'Affiliation': 'Ferring Pharmaceuticals, Global Biometrics, Copenhagen, Denmark.'}, {'ForeName': 'Joan-Carles', 'Initials': 'JC', 'LastName': 'Arce', 'Affiliation': 'Ferring Pharmaceuticals, Reproductive Medicine & Maternal Health, Copenhagen, Denmark. Electronic address: jca@ferring.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2020.10.059']
2670,33272368,Effect of Empagliflozin on Hemodynamics in Patients With Heart Failure and Reduced Ejection Fraction.,"BACKGROUND
Inhibition of the sodium-glucose cotransporter-2 (SGLT2i) improves outcomes in patients with heart failure (HF) and reduced ejection fraction (HFrEF), but the mechanism by which they improve outcomes remains unclear.
OBJECTIVES
This study aimed to investigate the effects of sodium-glucose cotransporter-2 inhibitor empagliflozin on central hemodynamics in patients with HF and HFrEF.
METHODS
This investigator-initiated, double-blinded, placebo-controlled, randomized trial enrolled 70 patients with HFrEF from March 6, 2018, to September 10, 2019. Patients were assigned to empagliflozin of 10 mg or matching placebo once daily on guideline-driven HF therapy for 12 weeks. The primary outcome was ratio of pulmonary capillary wedge pressure (PCWP) to cardiac index (CI) at peak exercise after 12 weeks. Patients underwent right-heart catheterization at rest and during exercise at baseline and 12-week follow-up.
RESULTS
Patients with HFrEF, mean age of 57 years, mean left-ventricular ejection fraction, 26%, and 12 (17%) with type 2 diabetes mellitus were randomized. There was no significant treatment effect on peak PCWP/CI (-0.13 mm Hg/l/min/m 2 ; 95% confidence interval: -1.60 to 1.34 mm Hg/l/min/m 2 ; p = 0.86). Considering hemodynamics over the full range of exercise loads, PCWP was significantly reduced (-2.40 mm Hg; 95% confidence interval: -3.96 to -0.84 mm Hg; p = 0.003), but not CI (-0.09 l/min/m 2 ; 95% confidence interval: -0.14 to 0.32 l/min/m 2 ; p = 0.448) by empagliflozin. This was consistent among patients with and without type 2 diabetes.
CONCLUSIONS
Among patients with stable HFrEF, empagliflozin for 12 weeks reduced PCWP compared with placebo. There was no significant improvement in neither CI nor PCWP/CI at rest or exercise.",2020,There was no significant treatment effect on peak PCWP/CI (-0.13 mm ,"['mean left-ventricular ejection fraction, 26%, and 12 (17%) with type 2 diabetes mellitus', 'patients with HF and HFrEF.\nMETHODS', 'Patients', 'Patients with HFrEF, mean age of 57 years', '70 patients with HFrEF from March 6, 2018, to September 10, 2019', 'patients with and without type 2 diabetes', 'patients with heart failure (HF) and reduced ejection fraction (HFrEF']","['empagliflozin', 'placebo', 'sodium-glucose cotransporter-2 inhibitor empagliflozin', 'sodium-glucose cotransporter-2 (SGLT2i', 'right-heart catheterization at rest and during exercise at baseline and 12-week follow-up', 'Empagliflozin', 'empagliflozin of 10\xa0mg or matching placebo once daily on guideline-driven HF therapy']","['peak PCWP/CI', 'PCWP', 'CI nor PCWP/CI', 'ratio of pulmonary capillary wedge pressure (PCWP) to cardiac index (CI) at peak exercise', 'central hemodynamics', 'Failure and Reduced Ejection Fraction']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",70.0,0.414493,There was no significant treatment effect on peak PCWP/CI (-0.13 mm ,"[{'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense C, Denmark; Steno Diabetes Center Odense, Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark. Electronic address: massar.omar@rsyd.dk.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Frederiksen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Endocrinology, Copenhagen University Hospital Rigshospitalet, København Ø, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Mikael Kjær', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense C, Denmark.'}, {'ForeName': 'Sören', 'Initials': 'S', 'LastName': 'Möller', 'Affiliation': 'OPEN, Open Patient data Explorative Network, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense C, Denmark.'}, {'ForeName': 'Mulham', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Copenhagen University, Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Cardiology, Copenhagen University, Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Cardiovascular Medicine, Mayo Clinic Hospital, Rochester, Minnesota.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, Odense C, Denmark; Department of Endocrinology, Copenhagen University Hospital Rigshospitalet, København Ø, Denmark.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.10.005']
2671,33272309,The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES
This study aims to assess the effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19).
TRIAL DESIGN
This is a Double-Blind, Placebo-Controlled, Parallel Arm, Randomized Phase ΙΙ Clinical Trial.
PARTICIPANTS
Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products. Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran.
INTERVENTION AND COMPARATOR
Participants (N=40) in the intervention group will receive an identical propolis tablet (containing 300 mg Iranian green propolis extract) three times a day for a period of 2 weeks. Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks. All tablets are prepared by the Reyhan Naghsh Jahan Pharmaceutical Co., Isfahan, Iran.
MAIN OUTCOMES
The main outcomes are changes in the coronavirus disease's clinical symptoms including duration and severity from baseline to the end of 2 weeks.
RANDOMIZATION
Eligible patients will be randomly allocated in a 1:1 ratio to the intervention or control group. Randomization will be performed on the basis of permuted block sizes of 4 and will be stratified according to sex categories. Randomization sequences will be prepared by the trial's pharmacist with the use of random-number tables.
BLINDING (MASKING)
The trial-group assignment will be concealed from all participants, clinicians, and investigators throughout the trial. To ensure blinding, randomization sequences will be kept in identical, opaque, sealed, sequentially numbered envelopes. Only the trial's pharmacist has access to the randomization list. Also, the placebo tablet will be similar to the propolis tablet in terms of texture, taste, color, odor, and weight. Both tablets will be provided in containers that are completely identical in weight, shape, labelling, and packaging.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)
The calculated total sample size is 80 patients, with 40 patients in each group.
TRIAL STATUS
The protocol is Version 1.0, October 10, 2020. Recruitment began August 22, 2020, and is anticipated to be completed by March 21, 2021.
TRIAL REGISTRATION
The name of the trial register: The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A randomized, double-blind, placebo-controlled clinical trial. IRCT registration number: IRCT20200802048267N1 . Date of trial registration: 20 October 2020, retrospectively registered.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks.,"['Patients will be recruited from the Al-Zahra hospital in Isfahan city, Isfahan, Iran', '80 patients, with 40 patients in each group', 'patients with coronavirus (COVID-19', 'Patients with the confirmed COVID-19 based on the PCR test are eligible to participate in the trial if they are 18 to 75 years of age and have no history of the current use of warfarin or propolis supplement and presence of sensitivity to bee products']","['placebo', 'propolis supplementation', 'identical propolis tablet (containing 300\u2009mg Iranian green propolis extract', 'Placebo', 'identical placebo tablet (containing 300 mg microcrystalline cellulose']","['texture, taste, color, odor, and weight', 'clinical symptoms', ""coronavirus disease's clinical symptoms including duration and severity""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}]","[{'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.632354,Participants (N=40) in the control group will receive an identical placebo tablet (containing 300 mg microcrystalline cellulose) three times a day for 2 weeks.,"[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Miryan', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Soleimani', 'Affiliation': 'Nutritional Sciences Department, School of Nutrition Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Dehghani', 'Affiliation': 'Department of Tissue Engineering and Regenerative Medicine, School of Advanced Technologies in Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Sohrabi', 'Affiliation': 'Department of Emergency Medicine, Alzahra University Hospital, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Khorvash', 'Affiliation': 'Department of Infectious Diseases, Faculty ofMedicine, Nosocomial Infections Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bagherniya', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sayed Mazaher', 'Initials': 'SM', 'LastName': 'Sayedi', 'Affiliation': 'Honey Bee Expert of Isfahan Agricultural and Natural Resources Research Center, Arib Ave., Isfahan, 81746-73461, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Askari', 'Affiliation': 'Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. askari@mui.ac.ir.'}]",Trials,['10.1186/s13063-020-04934-7']
2672,33272281,Infant sex modifies associations between placental malaria and risk of malaria in infancy.,"BACKGROUND
Placental malaria (PM) has been associated with a higher risk of malaria during infancy. However, it is unclear whether this association is causal, and is modified by infant sex, and whether intermittent preventive treatment in pregnancy (IPTp) can reduce infant malaria by preventing PM.
METHODS
Data from a birth cohort of 656 infants born to HIV-uninfected mothers randomised to IPTp with dihydroartemisinin-piperaquine (DP) or Sulfadoxine-pyrimethamine (SP) was analysed. PM was categorized as no PM, active PM (presence of parasites), mild-moderate past PM (> 0-20% high powered fields [HPFs] with pigment), or severe past PM (> 20% HPFs with pigment). The association between PM and incidence of malaria in infants stratified by infant sex was examined. Causal mediation analysis was used to test whether IPTp can impact infant malaria incidence via preventing PM.
RESULTS
There were 1088 malaria episodes diagnosed among infants during 596.6 person years of follow-up. Compared to infants born to mothers with no PM, the incidence of malaria was higher among infants born to mothers with active PM (adjusted incidence rate ratio [aIRR] 1.30, 95% CI 1.00-1.71, p = 0.05) and those born to mothers with severe past PM (aIRR 1.28, 95% CI 0.89-1.83, p = 0.18), but the differences were not statistically significant. However, when stratifying by infant sex, compared to no PM, severe past PM was associated a higher malaria incidence in male (aIRR 2.17, 95% CI 1.45-3.25, p < 0.001), but not female infants (aIRR 0.74, 95% CI 0.46-1.20, p = 0.22). There were no significant associations between active PM or mild-moderate past PM and malaria incidence in male or female infants. Male infants born to mothers given IPTp with DP had significantly less malaria in infancy than males born to mothers given SP, and 89.7% of this effect was mediated through prevention of PM.
CONCLUSION
PM may have more severe consequences for male infants, and interventions which reduce PM could mitigate these sex-specific adverse outcomes. More research is needed to better understand this sex-bias between PM and infant malaria risk. Trial registration ClinicalTrials.gov, NCT02793622. Registered 8 June 2016, https://clinicaltrials.gov/ct2/show/NCT02793622.",2020,"Male infants born to mothers given IPTp with DP had significantly less malaria in infancy than males born to mothers given SP, and 89.7% of this effect was mediated through prevention of PM.
","['male or female infants', 'male infants', '1088 malaria episodes diagnosed among infants during 596.6 person years of follow-up', 'Data from a birth cohort of 656 infants born to HIV-uninfected mothers randomised to', 'Male infants born to mothers given']","['IPTp with DP', 'IPTp with dihydroartemisinin-piperaquine (DP) or Sulfadoxine-pyrimethamine (SP']","['active PM or mild-moderate past PM and malaria incidence', 'malaria in infancy', 'malaria incidence', 'incidence of malaria']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}]",,0.149806,"Male infants born to mothers given IPTp with DP had significantly less malaria in infancy than males born to mothers given SP, and 89.7% of this effect was mediated through prevention of PM.
","[{'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK. akakuru@idrc-uganda.org.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Roh', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, 2C Nakasero Hill Road, Kampala, Uganda.'}, {'ForeName': 'Teddy', 'Initials': 'T', 'LastName': 'Ochieng', 'Affiliation': 'Infectious Diseases Research Collaboration, 2C Nakasero Hill Road, Kampala, Uganda.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ategeka', 'Affiliation': 'Infectious Diseases Research Collaboration, 2C Nakasero Hill Road, Kampala, Uganda.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Ochokoru', 'Affiliation': 'Infectious Diseases Research Collaboration, 2C Nakasero Hill Road, Kampala, Uganda.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Nakalembe', 'Affiliation': 'Department of Obstetrics and Gynaecology, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'Department of Pediatrics, University of California, San Francisco, USA.'}, {'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Staedke', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, USA. prasj@stanford.edu.'}]",Malaria journal,['10.1186/s12936-020-03522-z']
2673,33272279,The effect of active occupational stress management on psychosocial and physiological wellbeing: a pilot study.,"BACKGROUND
The aim of the study was to address the working population with an occupational stress prevention program using mHealth solution and encourage them for healthy lifestyle choices.
METHODS
Seventeen participants were randomized from the corporate setting. A 24alife app with a good compliance program was selected. Test battery has been designed to test the physical readiness, psychological evaluation and biological blood markers for stress. Participants were followed up after 30, 60 and 90 days, respectively, within the intervention period. Weight of participants was tracked three times per month. Univariate analysis compared the continuous variables by One-Way Repeated-Measures ANOVA test when the data were normally distributed, or Wilcoxon rank sum test for abnormal distribution of variables.
RESULTS
Participants used the app with a compliance rate of 94.1%. The psychological evaluation revealed higher motivation for work, lower burnout scores and participants gave subjective responses of better general wellbeing. Some of the participants lost up to four kg of body mass. Physical readiness has also improved.
CONCLUSIONS
Results of mHealth projects on corporate could include primary health care institutions and health ministry to extend the existing system to patients' pockets where they can monitor their disease and increase the ability of self-care.",2020,"The psychological evaluation revealed higher motivation for work, lower burnout scores and participants gave subjective responses of better general wellbeing.",['Seventeen participants'],['active occupational stress management'],['psychosocial and physiological wellbeing'],"[{'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}]",17.0,0.023851,"The psychological evaluation revealed higher motivation for work, lower burnout scores and participants gave subjective responses of better general wellbeing.","[{'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Jukic', 'Affiliation': 'Department of Internal medicine, Family medicine and History of Medicine, Faculty of Medicine Josip Juraj Strossmayer, Osijek, Croatia.'}, {'ForeName': 'Alojz', 'Initials': 'A', 'LastName': 'Ihan', 'Affiliation': 'Institute of Microbiology and Immunology, Medical Faculty of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Vojko', 'Initials': 'V', 'LastName': 'Strojnik', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Stubljar', 'Affiliation': 'Department of Research & Development, In-Medico, Mestni trg 11, 8330, Metlika, Slovenia. d.stubljar@gmail.com.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Starc', 'Affiliation': 'Chair of Public Health, Faculty of Health Sciences, University of Ljubljana, Ljubljana, Slovenia.'}]",BMC medical informatics and decision making,['10.1186/s12911-020-01347-z']
2674,33272244,Addressing sickness absence among adolescents and young adults: an evaluation of the Medical Advice for Sick-reported Students intervention.,"BACKGROUND
Sickness absence is associated with lower school achievements and early school leaving. The Medical Advice for Sick-reported Students (MASS) intervention is a proactive school-based intervention focused primarily on early identification and reduction of sickness absence. This study used a program evaluation framework to evaluate the MASS intervention among intermediate vocational education students and Youth Health Care professionals. Outcome indicators were primarily number of sick days, education fit, and school performance, and secondarily, seven health indicators. Process indicators were dose delivered and received, satisfaction, and experience.
METHODS
The MASS intervention evaluation was conducted in ten intermediate vocational education schools. Students with extensive sickness absence from school in the past three months were included in either the intervention or control condition. Students completed a baseline and a six-month follow-up self-report questionnaire. Linear and logistic regression analyses were applied. Students and Youth Health Care professionals completed an evaluation form regarding their satisfaction and experience with the intervention.
RESULTS
Participants (n = 200) had a mean age of 18.6 years (SD = 2.02) and 78.5% were female. The MASS intervention showed positive results on decreasing sickness absence in days (β = -1.13, 95% CI = -2.22;-0.05, p < 0.05) and on decreasing depressive symptoms (β = -4.11, 95% CI = -7.06;-1.17, p < 0.05). No effects were found for other health indicators (p > 0.05). A significant interaction revealed a decline in sickness absence in males (p < 0.05) but not in females (p > 0.05). Youth Health Care professionals found the application of the MASS intervention useful (n = 35 forms). The mean rating of students for the consultation within the MASS intervention was an 8.3 (SD = 1.3) out of 10 (n = 14 forms).
CONCLUSIONS
Our study provides some indication that the MASS intervention has positive effects on decreasing both sickness absence and depressive symptoms among intermediate vocational education students. The Youth Health Care professionals who provided the consultation as part of the MASS intervention considered the intervention to be useful and stated that the consultation was delivered as intended in almost all cases. Students were generally satisfied with the intervention. We recommend that future research evaluates the MASS intervention in a large randomized controlled trial with a longer follow-up.
TRIAL REGISTRATION
This study was prospectively registered in the Netherlands Trial Register under number NTR5556 , in October 2015.",2020,"The MASS intervention showed positive results on decreasing sickness absence in days (β = -1.13, 95% CI = -2.22;-0.05, p < 0.05) and on decreasing depressive symptoms (β = -4.11, 95% CI = -7.06;-1.17, p < 0.05).","['Netherlands Trial Register under number NTR5556 , in October 2015', 'adolescents and young adults', 'intermediate vocational education students', 'Students with extensive sickness absence from school in the past three\xa0months were included in either the intervention or control condition', 'Participants (n\u2009=\u2009200) had a mean age of 18.6\u2009years (SD\u2009=\u20092.02) and 78.5% were female', 'intermediate vocational education students and Youth Health Care professionals', 'Students and Youth Health Care professionals']",['MASS intervention'],"['primarily number of sick days, education fit, and school performance, and secondarily, seven health indicators', 'depressive symptoms', 'sickness absence', 'sickness absence and depressive symptoms']","[{'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0042933', 'cui_str': 'Vocational schooling'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0242806', 'cui_str': 'Illness Days'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]",,0.0457909,"The MASS intervention showed positive results on decreasing sickness absence in days (β = -1.13, 95% CI = -2.22;-0.05, p < 0.05) and on decreasing depressive symptoms (β = -4.11, 95% CI = -7.06;-1.17, p < 0.05).","[{'ForeName': 'Suzanne J', 'Initials': 'SJ', 'LastName': 'van den Toren', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, P.O. Box 2040, Rotterdam, 3000, CA, the Netherlands.'}, {'ForeName': 'Carmen B', 'Initials': 'CB', 'LastName': 'Franse', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, P.O. Box 2040, Rotterdam, 3000, CA, the Netherlands.'}, {'ForeName': 'Yvonne T M', 'Initials': 'YTM', 'LastName': 'Vanneste', 'Affiliation': 'Dutch Center for Youth Health (NCJ), Utrecht, the Netherlands.'}, {'ForeName': 'Rienke', 'Initials': 'R', 'LastName': 'Bannink', 'Affiliation': 'Center for Child and Family Rotterdam Rijnmond, Rotterdam, the Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Lugtenberg', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, P.O. Box 2040, Rotterdam, 3000, CA, the Netherlands.'}, {'ForeName': 'Wico C', 'Initials': 'WC', 'LastName': 'Mulder', 'Affiliation': 'Dutch Center for Youth Health (NCJ), Utrecht, the Netherlands.'}, {'ForeName': 'Marlou L A', 'Initials': 'MLA', 'LastName': 'de Kroon', 'Affiliation': 'Department of Health Sciences, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'van Grieken', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, P.O. Box 2040, Rotterdam, 3000, CA, the Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Raat', 'Affiliation': 'Department of Public Health, Erasmus University Medical Center, P.O. Box 2040, Rotterdam, 3000, CA, the Netherlands. h.raat@erasmusmc.nl.'}]",BMC public health,['10.1186/s12889-020-09809-9']
2675,33272223,Treatment of established status epilepticus in the elderly - a study protocol for a prospective multicenter double-blind comparative effectiveness trial (ToSEE).,"BACKGROUND
Status epilepticus (SE) is a common neurological emergency condition that especially affects the elderly and old population. Older people with SE frequently have non-convulsive SE (NCSE) and are also at special risk of suffering a poor outcome. The application of benzodiazepines fails to control SE in about one third of the cases. For benzodiazepine refractory SE (BRSE) in elderly, there is little evidence that would justify the choice of one of the commonly used antiepileptic drugs. The present study aims to generate evidence for the treatment of BRSE in this age group.
METHODS
We will conduct a prospective, randomized, double-blind comparative effectiveness study in more than twenty hospitals in Germany over a four-year period. Four hundred and seventy-seven elderly patients (≥ 65 years old) diagnosed with BRSE will be allocated by 1:1 randomization to receive either levetiracetam or valproate. All types of SE will be considered. For the diagnosis NCSE a verification by EEG is required. Levetiracetam or valproate will be administered in one single infusion. The primary endpoint is the stable cessation of ictal activity 15 min after the start of infusion persisting for the following 45 min of observation. EEG recording is maintained over the whole observation period, clinical examinations are conducted in predefined intervals. In case of treatment success patients and study staff remain blinded until 60 min after the start of the infusion. Adverse events will be recorded until the end of the study. EEG data will be reviewed by two external independent experts. To obtain data about the further treatment of SE, intrahospital complications and the functional outcome in the short term the study participants will be observed until the day of discharge or day 30 whichever is earliest.
DISCUSSION
ToSEE is the first study which shall deliver evidence for the SE-therapy in the elderly and old population in a controlled prospective comparator study. By design it also shall collect information about therapy regimes and outcome aspects of this disease.
TRIAL REGISTRATION
The trial has been registered at the German Clinical Trials Register on 3 July, 2020 ( DRKS00022308 , https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00022308 ).",2020,The primary endpoint is the stable cessation of ictal activity 15 min after the start of infusion persisting for the following 45 min of observation.,"['more than twenty hospitals in Germany over a four-year period', 'Older people with SE', 'Four hundred and seventy-seven elderly patients (≥ 65\u2009years old) diagnosed with BRSE']","['benzodiazepine refractory SE (BRSE', 'Levetiracetam or valproate', 'benzodiazepines', 'levetiracetam or valproate']","['Adverse events', 'stable cessation of ictal activity']","[{'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038220', 'cui_str': 'Status epilepticus'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",477.0,0.127118,The primary endpoint is the stable cessation of ictal activity 15 min after the start of infusion persisting for the following 45 min of observation.,"[{'ForeName': 'Annekatrin', 'Initials': 'A', 'LastName': 'Müller', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany. annekatrin.mueller@medizin.uni-leipzig.de.'}, {'ForeName': 'Anett', 'Initials': 'A', 'LastName': 'Schmiedeknecht', 'Affiliation': 'Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Mende', 'Affiliation': 'Clinical Trial Centre Leipzig, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Awissus', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Rosenow', 'Affiliation': 'Epilepsy Center Frankfurt Rhein-Main, Department of Neurology, University Hospital Frankfurt and LOEWE Center for Personalized Translational Epilepsy Research (CePTER) Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Hamer', 'Affiliation': 'Department of Neurology, Erlangen Epilepsy Center, University of Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Classen', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig, Germany.'}]",BMC neurology,['10.1186/s12883-020-02001-x']
2676,33271884,Using an e-Health Intervention to Reduce Prolonged Sitting in UK Office Workers: A Randomised Acceptability and Feasibility Study.,"Low-cost workplace interventions are required to reduce prolonged sitting in office workers as this may improve employees' health and well-being. This study aimed to assess the acceptability and feasibility of an e-health intervention to reduce prolonged sitting among sedentary UK-based office workers. Secondary aims were to describe preliminary changes in employee health, mood and work productivity after using an e-health intervention. Healthy, university office workers (n = 14) completed this study. An 8 week randomised crossover design was used, consisting of two trials: Intervention (computer-based prompts) and Control. Eligibility and retention rates were recorded to assess the feasibility of the trial and interviews were conducted following the intervention to explore its acceptability. Sitting, standing and stepping were objectively assessed prior to and during week 8 of each trial. Before and after each trial, measurements of vascular function, cerebrovascular function, mood and work productivity were obtained. This study had eligibility and retention rates of 54.5% and 77.8%, respectively. Participants expressed a lack of autonomy and disruption to their workflow when using the e-health intervention, raising concerns over its acceptability and long-term implementation. Preliminary data indicate that the intervention may improve the patterning of activity accrued during work hours, with increases in the number of standing and stepping bouts completed, in addition to improving vascular function. This e-health intervention is feasible to deliver in a cohort of university office workers. However, adaptations to its implementation, such as personalised settings, are needed to increase acceptability before larger trials can be conducted.",2020,Low-cost workplace interventions are required to reduce prolonged sitting in office workers as this may improve employees' health and well-being.,"['UK Office Workers', 'sedentary UK-based office workers', 'Healthy, university office workers (n = 14) completed this study']","['Intervention (computer-based prompts) and Control', 'e-health intervention']","['eligibility and retention rates', 'Eligibility and retention rates', 'employee health, mood and work productivity', 'vascular function, cerebrovascular function, mood and work productivity']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0079272', 'cui_str': 'Employee Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",14.0,0.0670672,Low-cost workplace interventions are required to reduce prolonged sitting in office workers as this may improve employees' health and well-being.,"[{'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Carter', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Draijer', 'Affiliation': 'Unilever Foods Innovation Centre, Wageningen, The Netherlands.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Maxwell', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Morris', 'Affiliation': 'Department of Health Research, Lancaster University, Lancaster LA1 4YW, UK.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Pedersen', 'Affiliation': 'Active Work Laboratory, School of Education, University of Tasmania, Launceston 7250, Australia.'}, {'ForeName': 'Lee E F', 'Initials': 'LEF', 'LastName': 'Graves', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Hopkins', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool L3 3AF, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17238942']
2677,33271745,"Can Desensitizing Toothpastes Also Have an Effect on Gingival Inflammation? A Double-Blind, Three-Treatment Crossover Clinical Trial.","BACKGROUND
Many desensitizing toothpastes exist commercially; however, few clinical trials have investigated their anti-inflammatory effects. This study aimed to evaluate the anti-inflammatory effect and patient appreciation of two toothpastes containing desensitizing agents: (1) a zinc-carbonate-hydroxyapatite nanoparticle (CHA) and (2) a calcium sodium phosphosilicate bioactive glass (CSPS).
METHODS
CHA and CSPS were compared with an anti-inflammatory and antibacterial herbal based toothpaste (HB). The aims were accomplished by comparing the following outcomes: (1) the reduction in plaque and bleeding score (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS), respectively); (2) the antibacterial activity (AbA) of the toothpaste by saliva samples; (3) the patient appreciation score (Visual Analogue Scale; VAS). Clinical parameters were assessed at baseline and 14 days post-treatment.
RESULTS
The final sample consisted of 25 subjects, aged between 20 and 58 years. Although no differences in FMPS were reported ( p > 0.05), both desensitizing toothpastes showed an improvement in FMBS. CSPS and HB recorded more AbA compared to CHA ( p < 0.05). Moreover, HB resulted in a higher VAS score than both desensitizing toothpastes ( p < 0.05).
CONCLUSION
In conclusion, only CSPS displayed a similar anti-inflammatory effect compared to HB. Despite the low VAS score, CSPS could be considered as a valid and effective toothpaste in subjects with both dentin hypersensitivity and inflamed gums, highlighting its utility in clinical practice.",2020,"Moreover, HB resulted in a higher VAS score than both desensitizing toothpastes ( p < 0.05).
","['subjects with both dentin hypersensitivity and inflamed gums', '25 subjects, aged between 20 and 58 years']","['toothpastes containing desensitizing agents: (1) a zinc-carbonate-hydroxyapatite nanoparticle (CHA) and (2) a calcium sodium phosphosilicate bioactive glass (CSPS', 'anti-inflammatory and antibacterial herbal based toothpaste (HB']","['CSPS and HB', 'plaque and bleeding score (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS), respectively); (2) the antibacterial activity (AbA) of the toothpaste by saliva samples; (3) the patient appreciation score (Visual Analogue Scale; VAS', 'FMBS', 'FMPS', 'VAS score']","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0078772', 'cui_str': 'zinc carbonate'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0007026', 'cui_str': 'Carbonate'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0067984', 'cui_str': 'N-formylmethionylphenylalanine'}]",,0.183916,"Moreover, HB resulted in a higher VAS score than both desensitizing toothpastes ( p < 0.05).
","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Monterubbianesi', 'Affiliation': 'Department of Clinical Sciences and Stomatology, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}, {'ForeName': 'Scilla', 'Initials': 'S', 'LastName': 'Sparabombe', 'Affiliation': 'Department of Clinical Sciences and Stomatology, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Tosco', 'Affiliation': 'Department of Clinical Sciences and Stomatology, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}, {'ForeName': 'Fabia', 'Initials': 'F', 'LastName': 'Profili', 'Affiliation': 'Department of Clinical Sciences and Stomatology, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mascitti', 'Affiliation': 'Department of Clinical Sciences and Stomatology, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}, {'ForeName': 'Andrell', 'Initials': 'A', 'LastName': 'Hosein', 'Affiliation': 'Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Putignano', 'Affiliation': 'Department of Clinical Sciences and Stomatology, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Orsini', 'Affiliation': 'Department of Clinical Sciences and Stomatology, Polytechnic University of Marche, Via Tronto 10, 60126 Ancona, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17238927']
2678,33271639,International Journal of Geriatric Psychiatry The Dementia Early Stage Cognitive Aids New Trial (DESCANT) intervention: a goal attainment scaling approach to promote self-management.,"OBJECTIVES
This paper investigated goals identified by people with dementia and their carers to promote the self-management of symptoms and abilities; measured achievement using goal attainment scaling (GAS); and explored the reflections of Dementia Support Practitioners (DSPs) facilitating it.
METHODS
and design: Within this pragmatic randomised trial DSPs gave memory aids, training and support to people with mild to moderate dementia and their carers at home. Data were collected across seven NHS Trusts in England and Wales (2016-2018) and abstracted from intervention records and semi-structured interviews with DSPs delivering the intervention, supplemented by a subset of the trial dataset. Measures were created to permit quantification and descriptive analysis and interview data thematically analysed. A GAS measure for this intervention in this client group was derived.
RESULTS
Engagement was high across the 117 participants and 293 goals were identified. These reflected individual circumstances and needs; and enabled classification and assessment of their attainment. Seventeen goal types were identified across six domains: self-care; household tasks; daily occupation; orientation; communication; and well-being and safety. On average participants achieved nominally significant improvement regarding the specified goals of 1.4 with standard deviation of 0.6. Five interviews suggested that DSPs' experiences of goal setting were also positive.
CONCLUSIONS
GAS is useful for assessing psychosocial interventions for people with early-stage dementia. It has a utility in identifying goals, promoting self-management and providing a personalised outcome measure. There is a strong case for exploring whether these clear benefits translate to other interventions in other populations in other places. This article is protected by copyright. All rights reserved.",2020,On average participants achieved nominally significant improvement regarding the specified goals of 1.4 with standard deviation of 0.6.,"['people with mild to moderate dementia and their carers at home', 'people with dementia and their carers', 'people with early-stage dementia', '117 participants and 293 goals were identified']",['GAS'],['tasks; daily occupation; orientation; communication; and well-being and safety'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0562418,On average participants achieved nominally significant improvement regarding the specified goals of 1.4 with standard deviation of 0.6.,"[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Chester', 'Affiliation': 'Institute of Mental Health, The University of Nottingham, Jubilee Campus University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Beresford', 'Affiliation': 'School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Ellen Wilkinson Building, Manchester, M15 6JA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Clarkson', 'Affiliation': 'School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Ellen Wilkinson Building, Manchester, M15 6JA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Entwistle', 'Affiliation': 'Department of Psychology, Lancaster University, Fylde College, Lancaster, LA1 4YF.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gillan', 'Affiliation': 'Formerly of School of Health Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Ellen Wilkinson Building, Manchester, M15 6JA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hughes', 'Affiliation': 'Institute of Mental Health, The University of Nottingham, Jubilee Campus University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Orrell', 'Affiliation': 'Institute of Mental Health, The University of Nottingham, Jubilee Campus University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Pitts', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Bailrigg, Lancaster, LA1 4YG.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Russell', 'Affiliation': 'Swansea Trials Unit, Medical School Swansea University, Swansea, Wales, SA2 8PP.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Symonds', 'Affiliation': 'Institute of Mental Health, The University of Nottingham, School of Medicine, Jubilee Campus University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': 'Institute of Mental Healt, The University of Nottingham, Jubilee Campus University of Nottingham Innovation Park, Triumph Road, Nottingham, NG7 2TU.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of geriatric psychiatry,['10.1002/gps.5479']
2679,33271636,A Quasi-experimental Study of the Effectiveness of the Reitman Centre CARERS Group Intervention on Family Caregivers of Persons with Dementia.,"OBJECTIVES
This study aims to determine the effectiveness of the Reitman Centre CARERS program on key outcomes in family CGs of people with dementia. The Reitman Centre CARERS program is an innovative, group psychotherapeutic skills-training intervention based on integrated problem solving techniques (PST), simulation learning and group psychotherapy designed to address each CGs' unique situation.
METHOD
Family CGs of people with dementia (n=264) that were referred to Reitman Center and the partner sites were evaluated before and after completion of the 8-week CARERS program in comparison with a wait-list control group (n=83) who received regular care in a quasi-experimental, non-randomized, multiple group, multisite trial. General linear model was used to compare the results after adjusting for baseline measures and changes in the care recipients' daily activities (Katz-ADL).
RESULTS
The results indicated the effectiveness and superiority of the CARERS program over usual care on measures of CG's perceived stress, depression, burden, competence, role overload, emotion and avoidance-focused coping.
CONCLUSION
The CARERS program as a multi-component intervention is an effective intervention that significantly improves functioning, coping skills and well-being of dementia CGs. This article is protected by copyright. All rights reserved.",2020,"The results indicated the effectiveness and superiority of the CARERS program over usual care on measures of CG's perceived stress, depression, burden, competence, role overload, emotion and avoidance-focused coping.
","['Family CGs of people with dementia (n=264) that were referred to Reitman Center and the partner sites were evaluated before and after completion of the 8-week', 'Family Caregivers of Persons with Dementia', 'family CGs of people with dementia']","['CARERS program in comparison with a wait-list control group (n=83) who received regular care in a quasi-experimental', 'Reitman Centre CARERS Group Intervention', 'integrated problem solving techniques (PST), simulation learning and group psychotherapy', 'Reitman Centre CARERS program']","['functioning, coping skills and well-being of dementia CGs', 'stress, depression, burden, competence, role overload, emotion and avoidance-focused coping']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",,0.0180788,"The results indicated the effectiveness and superiority of the CARERS program over usual care on measures of CG's perceived stress, depression, burden, competence, role overload, emotion and avoidance-focused coping.
","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Sadavoy', 'Affiliation': 'Founder of Geriatric Psychiatry, FCPA (distinguished).'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Sajedinejad', 'Affiliation': ""The Cyril & Dorothy, Joel & Jill Reitman Centre for Alzheimer's Support and Training, Department of Psychiatry, Sinai Health, 60 Murray St, Suite L1-012, Toronto, Ontario, Canada, M5T 3L9.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Chiu', 'Affiliation': ""The Cyril & Dorothy, Joel & Jill Reitman Centre for Alzheimer's Support and Training, Department of Psychiatry, Sinai Health, 60 Murray St, Suite L1-012, Toronto, Ontario, Canada, M5T 3L9.""}]",International journal of geriatric psychiatry,['10.1002/gps.5481']
2680,33271534,Plasma Magnesium Concentrations and Risk of Incident Cancer in Adults with Hypertension: A Nested Case-Control Study.,"OBJECTIVE
The association between plasma magnesium and risk of incident cancer remains inconclusive in previous studies. We aimed to investigate the prospective relationship of baseline plasma magnesium concentrations with the risk of incident cancer and to examine possible effect modifiers.
METHODS
A nested case-control study with 228 incident cancer cases and 228 matched controls was conducted using data from the China Stroke Primary Prevention Trial (CSPPT), a randomized, double-blind, controlled trial, conducted from May 2008 to August 2013. Study outcomes included incident cancer and its subtypes.
RESULTS
When plasma magnesium concentrations were assessed as quartiles, a significantly higher incident risk of total cancer was found in participants in quartile 1 (<0.76 mmol/L; odds ratio [OR] = 2.70; 95% CI: 1.33-5.49) and quartile 4 (≥0.89 mmol/L; OR = 2.05; 95% CI: 1.12-3.76), compared with those in quartile 3 (0.83 to <0.89 mmol/L). In cancer site-specific analyses, similar trends were found for gastrointestinal cancer, esophageal cancer, gastric cancer, breast cancer, lung cancer, and other cancers. Furthermore, none of the variables, including age, sex, current smoking status, current alcohol intake, BMI, systolic blood pressure, and total cholesterol levels at baseline significantly modified the association between plasma magnesium and cancer risk.
CONCLUSIONS
Both low and high plasma magnesium concentrations were significantly associated with an increased incident risk of cancer, compared with the reference concentrations of 0.83 to <0.89 mmol/L among hypertensive adults.",2020,"Both low and high plasma magnesium concentrations were significantly associated with an increased incident risk of cancer, compared with the reference concentrations of 0.83 to <0.89 mmol/L among hypertensive adults.","['Adults with Hypertension', '228 incident cancer cases and 228 matched controls was conducted using data from the China Stroke Primary Prevention Trial (CSPPT']",[],"['incident risk of cancer', 'plasma magnesium concentrations', 'Plasma Magnesium Concentrations and Risk of Incident Cancer', 'incident cancer and its subtypes', 'gastrointestinal cancer, esophageal cancer, gastric cancer, breast cancer, lung cancer', 'age, sex, current smoking status, current alcohol intake, BMI, systolic blood pressure, and total cholesterol levels', 'incident risk of total cancer']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0858137', 'cui_str': 'Plasma magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",228.0,0.172793,"Both low and high plasma magnesium concentrations were significantly associated with an increased incident risk of cancer, compared with the reference concentrations of 0.83 to <0.89 mmol/L among hypertensive adults.","[{'ForeName': 'Tengfei', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Chonglei', 'Initials': 'C', 'LastName': 'Bi', 'Affiliation': ""People's Hospital of RongCheng, RongCheng, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Huiyuan', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Lishun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Kidney Disease, The State Key Laboratory for Organ Failure Research, Guangdong Provincial Institute of Nephrology, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Genfu', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'Health Management College, Anhui Medical University, Hefei, China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Research Center, Shenzhen Evergreen Medical Institute, Shenzhen, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Public Health (Shenzhen), Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Guangdong Engineering Technology Center of Nutrition Transformation, Guangzhou, China.'}, {'ForeName': 'Jingang', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Chengguo', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, The First People's Hospital of Foshan, Foshan, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, East Hospital, Tongji University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiaang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Gould Academy, Bethel, Maine, USA.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Center for Kidney Disease, The State Key Laboratory for Organ Failure Research, Guangdong Provincial Institute of Nephrology, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, China, pharmaqin@126.com.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}]",Annals of nutrition & metabolism,['10.1159/000510214']
2681,33271509,A Moral Intervention Reduces Doping Likelihood in British and Greek Athletes: Evidence From a Cluster Randomized Control Trial.,"OBJECTIVES
The authors aimed to develop a moral intervention and to determine whether it was more effective in preventing doping than an educational (i.e., knowledge-based) intervention; their primary outcome was doping likelihood, and the secondary outcomes were moral identity, moral disengagement, moral atmosphere, and anticipated guilt.
METHODS
Eligible athletes (N = 303) in the United Kingdom and Greece took part in the study. The authors randomly assigned 33 clubs to either the moral or the educational intervention. They measured outcomes pre- and postintervention and at 3- and 6-month follow-up.
RESULTS
Athletes in both interventions in both countries reported lower doping likelihood and moral disengagement and higher guilt from pre- to postintervention. These effects were maintained at the 3- and 6-month follow-ups. There were no effects on moral identity or moral atmosphere.
CONCLUSIONS
In addition to disseminating information about doping, doping prevention programs should include content that focuses on moral variables.",2020,"RESULTS
Athletes in both interventions in both countries reported lower doping likelihood and moral disengagement and higher guilt from pre- to postintervention.","['Eligible athletes (N = 303) in the United Kingdom and Greece took part in the study', 'British and Greek Athletes']","['moral or the educational intervention', 'Moral Intervention']",['moral identity or moral atmosphere'],"[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337806', 'cui_str': 'Greeks'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}]",303.0,0.0643777,"RESULTS
Athletes in both interventions in both countries reported lower doping likelihood and moral disengagement and higher guilt from pre- to postintervention.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kavussanu', 'Affiliation': 'University of Birmingham.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hurst', 'Affiliation': 'Canterbury Christ Church University.'}, {'ForeName': 'Mariya', 'Initials': 'M', 'LastName': 'Yukhymenko-Lescroart', 'Affiliation': 'California State University.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Galanis', 'Affiliation': 'University of Thessaly.'}, {'ForeName': 'Ailish', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'Loughborough University.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Hatzigeorgiadis', 'Affiliation': 'University of Thessaly.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ring', 'Affiliation': 'University of Birmingham.'}]",Journal of sport & exercise psychology,['10.1123/jsep.2019-0313']
2682,33271506,Few Structural Brain Changes Associated With Moderate-Intensity Interval Training and Low-Intensity Continuous Training in a Randomized Trial of Fitness and Older Adults.,"This study utilized a randomized control trial to examine whether structural changes in the precuneus, insula, caudate, hippocampus, and putamen were related to exercise. A total of 197 healthy older adults with no evidence of dementia participated in moderate-intensity interval training or low-intensity continuous training for 16 weeks. Size decreased in the right hippocampus such that the effect of time was significant but the interaction with condition was not. For the left hippocampus, size decreased in the low-intensity continuous training condition but increased in the moderate-intensity continuous training plus interval training condition at the trend level. Finally, there was a significant time-by-condition interaction such that the thickness of the left insula increased for low-intensity continuous training and decreased for moderate-intensity continuous training plus interval training. Few structural changes were associated with the exercise intervention. Future studies should examine the effects of exercise on brain structure in high-risk or clinical populations for a longer period of time.",2020,"For the left hippocampus, size decreased in the low-intensity continuous training condition but increased in the moderate-intensity continuous training plus interval training condition at the trend level.","['Fitness and Older Adults', '197 healthy older adults with no evidence of dementia participated in moderate-intensity interval training or low-intensity continuous training for 16 weeks']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439230', 'cui_str': 'week'}]",[],[],197.0,0.0406255,"For the left hippocampus, size decreased in the low-intensity continuous training condition but increased in the moderate-intensity continuous training plus interval training condition at the trend level.","[{'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Martin-Willett', 'Affiliation': ''}, {'ForeName': 'Jarrod E', 'Initials': 'JE', 'LastName': 'Ellingson', 'Affiliation': ''}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Fries', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Helmuth', 'Affiliation': ''}, {'ForeName': 'Hollis', 'Initials': 'H', 'LastName': 'Karoly', 'Affiliation': ''}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Giordano', 'Affiliation': ''}, {'ForeName': 'Vince D', 'Initials': 'VD', 'LastName': 'Calhoun', 'Affiliation': ''}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Bryan', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0352']
2683,33271505,Additional Functional Performance Gains After 24-Week Unstable Strength Training With Cognitive Training in Community-Dwelling Healthy Older Adults: A Randomized Trial.,"The authors investigated the effects of unstable strength training (UST) without or with cognitive training (C+UST) on functional performance in community-dwelling older adults. A total of 50 participants were randomly assigned (1:1) to either 24 weeks of thrice-weekly UST (n = 25) or C+UST (n = 25). All participants performed moderate-intensity strength exercises using unstable surfaces, and C+UST participants simultaneously received cognitive training in addition to UST. Primary outcomes included measures of functional performance: single- and dual-task timed up and go tests. Secondary outcomes included dynamic balance, mobility, handgrip strength, flexibility, quality of life, and concern about falling. The authors observed similar improvements on functional performance through the interventions. The C+UST group experienced additional gains at completion (single-task timed up and go: -0.90 s, 95% confidence interval [-2.38, -0.03]; dual-task timed up and go: -4.80 s, 95% confidence interval [-8.65, -0.95]) compared with the UST group. Moreover, significant differences were observed in mobility (sitting-rising test: -1.34, 95% confidence interval [-2.00, -0.20]) at 24 weeks. Both exercise modes improved single-task functional performance, while adding cognitive-training-optimized dual-task functional performance gains.",2020,"Secondary outcomes included dynamic balance, mobility, handgrip strength, flexibility, quality of life, and concern about falling.","['A total of 50 participants', 'Community-Dwelling Healthy Older Adults', 'community-dwelling older adults']","['UST', '24-Week Unstable Strength Training With Cognitive Training', 'C+UST', 'cognitive training in addition to UST', 'cognitive-training-optimized dual-task functional performance gains', 'unstable strength training (UST) without or with cognitive training (C+UST']","['mobility (sitting-rising test', 'functional performance', 'single-task functional performance', 'Additional Functional Performance Gains', 'dynamic balance, mobility, handgrip strength, flexibility, quality of life, and concern about falling', 'functional performance: single- and dual-task timed up and go tests']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}]",50.0,0.0825003,"Secondary outcomes included dynamic balance, mobility, handgrip strength, flexibility, quality of life, and concern about falling.","[{'ForeName': 'Valéria Mayaly Alves', 'Initials': 'VMA', 'LastName': 'de Oliveira', 'Affiliation': ''}, {'ForeName': 'André Luiz Torres', 'Initials': 'ALT', 'LastName': 'Pirauá', 'Affiliation': ''}, {'ForeName': 'Bruno Remígio', 'Initials': 'BR', 'LastName': 'Cavalcante', 'Affiliation': ''}, {'ForeName': 'Natália Barros', 'Initials': 'NB', 'LastName': 'Beltrão', 'Affiliation': ''}, {'ForeName': 'Wevans Monthier', 'Initials': 'WM', 'LastName': 'de Farias', 'Affiliation': ''}, {'ForeName': 'Ana Carolina Rodarti', 'Initials': 'ACR', 'LastName': 'Pitangui', 'Affiliation': ''}, {'ForeName': 'Rodrigo Cappato', 'Initials': 'RC', 'LastName': 'de Araújo', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0050']
2684,33271504,Stand Up Now: A Sedentary Behavior Intervention in Older Adults of Moderate to Low Physical Function.,"OBJECTIVES
To examine the efficacy of an the intervention Stand Up Now (SUN) to reduce sedentary behavior (SB) and improve physical function and mobility.
METHODS
SUN included two groups: (a) focused on reducing total SB (SUNSL) and (b) focused on increasing sit-to-stand (STS) transitions (SUNSTS). The participants (N = 71; Mage = 87 ± 7 years) had 12 weekly health coaching sessions. SB, physical function, and mobility were measured at the baseline, 6, and 12 weeks via the activPAL, Short Physical Performance Battery, and the 8-foot up and go, respectively. Linear mixed models examined the outcome variables over time.
RESULTS
Both groups decreased sedentary time (1.3 ± 0.3 hr, p < .001), increased standing time (0.5 ± 0.2 hr, p < .02), and improved physical function (1.5 ± 0.4 points, p < .001) from the baseline to 6 weeks, and they maintained it at 12 weeks. SUNSTS increased STS transitions (5.4 ± 4.1, p < .001), while SUNSL had no changes (0.5 ± 3.1, p > .9). There were no changes in mobility for either group (0.5 ± 1.5 s, p > .05).
DISCUSSION
SUN demonstrates the efficacy to improve SB and physical function in older adults.",2020,"There were no changes in mobility for either group (0.5 ± 1.5 s, p > .05).
","['older adults', 'Older Adults of Moderate to Low Physical Function', 'SUN included two groups: (a', 'The participants (N = 71; Mage = 87 ± 7 years) had 12 weekly health coaching sessions']","['intervention Stand Up Now (SUN', 'Sedentary Behavior Intervention', 'focused on reducing total SB (SUNSL) and (b)\xa0focused on increasing sit-to-stand (STS) transitions (SUNSTS']","['mobility', 'SB and physical function', 'sedentary behavior (SB) and improve physical function and mobility', 'sedentary time', 'physical function', 'increased standing time', 'STS transitions', 'SB, physical function, and mobility']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444796', 'cui_str': 'Standing up'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]","[{'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]",,0.0224492,"There were no changes in mobility for either group (0.5 ± 1.5 s, p > .05).
","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Thralls Butte', 'Affiliation': ''}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Levy', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2020-0047']
2685,33278331,Clinical Evaluation of an Investigational 5ml Wearable Injector in Healthy Human Subjects.,"An investigational wearable injector (BD Libertas™ Wearable Injector) was evaluated in an early feasibility clinical study for functional performance, tissue effects, subject tolerability and acceptability of 5ml, non-Newtonian ~8cP subcutaneous placebo injections in 52 healthy adult subjects of two age groups (18-64, ≥65 years). Randomized wearable injector subcutaneous injections (n=208, 4/subject) were delivered to the right and left abdomen and thigh of each subject, 50% (1 thigh, 1 abdomen) with a defined movement sequence during injection. Injector functional performance was documented. Deposition was qualified and quantified with ultrasound. Tissue effects and tolerability (pain) were monitored through 24 hours with corresponding acceptability questionnaires administered through 72 hours. Wearable injectors (n=205) automatically inserted the needle, delivered 5ml ±5% in 5.42 minutes (SD 0.74) and retracted. Depots were entirely (93.2%) or predominantly (5.4%) localized within the target subcutaneous tissue. Slight to moderate wheals (63.9%) and erythema (75.1%) were observed with ≥50% resolution within 30-60 minutes. Subject pain (100mm Visual Analog Scale) peaked mid-injection (mean 9.1mm, SD 13.4) and rapidly resolved within 30 minutes (mean 0.4mm, SD 2.6). Subjects' peak pain (≥90.2%), injection site appearance (≥92.2%) and injector wear, size and removal (≥92.1%) were acceptable (Likert responses) with 100% likely to use the injector if prescribed. Injection site preference was divided between none (46%), abdomen (25%) or thigh (26.9%). The investigational wearable injector successfully delivered 5ml viscous subcutaneous injections. Tissue effects and pain were transient, well-tolerated and acceptable. Neither injection site, movement or subject age affected injector functional performance or subject pain and acceptability.",2020,"Subjects' peak pain (≥90.2%), injection site appearance (≥92.2%) and injector wear, size and removal (≥92.1%) were acceptable (Likert responses) with 100% likely to use the injector if prescribed.","['Healthy Human Subjects', '52 healthy adult subjects of two age groups (18-64, ≥65 years']","['5ml, non-Newtonian ~8cP subcutaneous placebo injections']","['erythema', 'injection site appearance', 'Subject pain', 'peak pain', 'Tissue effects and pain', 'Injection site preference', 'Injector functional performance', 'Tissue effects and tolerability (pain']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0181342', 'cui_str': 'Injector'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.044512,"Subjects' peak pain (≥90.2%), injection site appearance (≥92.2%) and injector wear, size and removal (≥92.1%) were acceptable (Likert responses) with 100% likely to use the injector if prescribed.","[{'ForeName': 'Wendy D', 'Initials': 'WD', 'LastName': 'Woodley', 'Affiliation': 'BD Technologies & Innovation, 21 Davis Drive, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yue', 'Affiliation': 'BD, 1 Becton Drive, Franklin Lakes, NJ, 07417, USA.'}, {'ForeName': 'Didier R', 'Initials': 'DR', 'LastName': 'Morel', 'Affiliation': 'BD, 11, rue Aristide Berges, Le Pont de Claix, Isère, 38801, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lainesse', 'Affiliation': 'BD, 2555 Boul. du Parc Technologique, Québec, Québec, G1P 4S5, Canada.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Pettis', 'Affiliation': 'BD Technologies & Innovation, 21 Davis Drive, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Natasha G', 'Initials': 'NG', 'LastName': 'Bolick', 'Affiliation': 'BD Technologies & Innovation, 21 Davis Drive, Research Triangle Park, NC, 27709, USA.'}]",Clinical and translational science,['10.1111/cts.12946']
2686,33278330,"Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of Vixotrigine in Healthy Volunteers.","Neuropathic pain affects ~ 6.9-10% of the general population and leads to loss of function, anxiety, depression, sleep disturbance, and impaired cognition. Here we report the safety, tolerability, and pharmacokinetics of a voltage- and use-dependent sodium channel blocker, vixotrigine, currently under investigation for the treatment of neuropathic pain conditions. The randomized, placebo-controlled, phase I clinical trials were split into single (SAD) and multiple ascending dose (MAD) studies. Healthy volunteers received oral vixotrigine as either single doses followed by a ≥ 7-day washout period for up to five dosing sessions (SAD, n = 30), or repeat doses (once or twice daily) for 14 and 28 days (MAD, n = 51). Adverse events (AEs), maximum observed vixotrigine plasma concentration (C max ), area under the concentration-time curve from predose to 24 hours postdose (AUC 0-24 ), time to C max (T max ), and terminal half-life (t 1/2 ), among others, were assessed. Drug-related AEs were reported in 47% and 53% of volunteers in the SAD and MAD studies, respectively, with dizziness as the most commonly reported drug-related AE. SAD results showed that C max and AUC increased with dose, T max was 1-2 hours, and t 1/2 was ~ 11 hours. A two-fold increase in accumulation was observed when vixotrigine was taken twice vs. once daily (MAD). Steady state was achieved from day 5 onward. These data indicate that oral vixotrigine is well tolerated when administered as single doses up to 825 mg and multiple doses up to 450 mg twice daily.",2020,"Drug-related AEs were reported in 47% and 53% of volunteers in the SAD and MAD studies, respectively, with dizziness as the most commonly reported drug-related AE.","['Healthy volunteers', 'neuropathic pain conditions', 'Healthy Volunteers']","['voltage- and use-dependent sodium channel blocker, vixotrigine', 'vixotrigine', 'Vixotrigine', 'placebo', 'oral vixotrigine']","['accumulation', 'loss of function, anxiety, depression, sleep disturbance, and impaired cognition', 'Adverse events (AEs), maximum observed vixotrigine plasma concentration (C max ), area under the concentration-time curve from predose to 24 hours postdose (AUC 0-24 ), time to C max (T max ), and terminal half-life', 'C max and AUC', 'Safety, Tolerability and Pharmacokinetics', 'safety, tolerability, and pharmacokinetics', 'Neuropathic pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0872271', 'cui_str': 'Sodium channel blocker'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]",,0.0449945,"Drug-related AEs were reported in 47% and 53% of volunteers in the SAD and MAD studies, respectively, with dizziness as the most commonly reported drug-related AE.","[{'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Naik', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Deb J', 'Initials': 'DJ', 'LastName': 'Steiner', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Versavel', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'GlaxoSmithKline, Harlow, UK.'}, {'ForeName': 'Regan', 'Initials': 'R', 'LastName': 'Fong', 'Affiliation': 'GlaxoSmithKline, King of Prussia, Pennsylvania, USA.'}]",Clinical and translational science,['10.1111/cts.12935']
2687,33278328,"A Randomized Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of Recombinant Erwinia Asparaginase (JZP-458) in Healthy Adult Volunteers.","L-asparaginase has been an important component of acute lymphoblastic leukemia (ALL) therapy for over 40 years, and is standard therapy during ALL induction and consolidation treatment. L-asparaginases are immunogenic and can induce hypersensitivity reactions; inability to receive asparaginase has been associated with poor patient outcomes. There are L-asparaginases of varied bacterial origins, with the most commonly used being E. coli; therefore, to ensure that patients who develop hypersensitivity to E. coli-derived asparaginases receive an adequate therapeutic course, alternative preparations are warranted. JZP-458 is a recombinant Erwinia asparaginase produced using a novel Pseudomonas fluorescens expression platform that yields an enzyme with no immunologic cross-reactivity to E. coli-derived asparaginases. To evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of JZP-458, a randomized, single-center, open-label, phase 1 study was conducted with JZP-458 given via intramuscular (IM) injection or intravenous (IV) infusion to healthy adult volunteers. At the highest doses tested for each route of administration (ie, 25 mg/m 2 IM and 37.5 mg/m 2 IV), JZP-458 achieved serum asparaginase activity (SAA) levels ≥0.1 IU/mL at 72 hours postdose for 100% of volunteers. Bioavailability for IM JZP-458 was estimated at 36.8% based on SAA data. All dose levels were well tolerated, with no unanticipated adverse events (AEs), no serious AEs, and no grade 3 or higher AEs. Based on PK and safety data, the recommended JZP-458 starting dose for the pivotal phase 2/3 study in adult and pediatric patients is 25 mg/m 2 IM and 37.5 mg/m 2 IV on a Monday/Wednesday/Friday dosing schedule.",2020,"All dose levels were well tolerated, with no unanticipated adverse events (AEs), no serious AEs, and no grade 3 or higher AEs.","['healthy adult volunteers', 'Healthy Adult Volunteers']","['JZP-458 given via intramuscular (IM) injection or intravenous (IV) infusion', 'Recombinant Erwinia Asparaginase (JZP-458', 'JZP-458']","['Safety, Tolerability, and Pharmacokinetics', 'serum asparaginase activity (SAA) levels', 'safety, tolerability, and pharmacokinetics (PK', 'tolerated, with no unanticipated adverse events (AEs), no serious AEs, and no grade 3 or higher AEs', 'Bioavailability for IM JZP-458']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C5191377', 'cui_str': '458'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C3255208', 'cui_str': 'Crisantaspase'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C5191377', 'cui_str': '458'}]",,0.0633759,"All dose levels were well tolerated, with no unanticipated adverse events (AEs), no serious AEs, and no grade 3 or higher AEs.","[{'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Lin', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Hernandez-Illas', 'Affiliation': 'QPS Miami Research Associates (Miami Clinical Research), Miami, FL, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Rey', 'Affiliation': 'QPS Miami Research Associates (Miami Clinical Research), Miami, FL, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Jenkins', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Reddy', 'Initials': 'R', 'LastName': 'Chandula', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Silverman', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Mi Rim', 'Initials': 'MR', 'LastName': 'Choi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}]",Clinical and translational science,['10.1111/cts.12947']
2688,33278293,Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA for Mixed Urinary Incontinence: A Randomized Controlled Trial.,"OBJECTIVE
To evaluate whether retropubic midurethral sling combined with onabotulinumtoxinA is more effective than sling alone in improving mixed urinary incontinence symptoms.
METHODS
We conducted a prospective, double-blind, randomized, controlled trial of women with mixed urinary incontinence, planning to undergo midurethral sling. Women were randomly assigned to receive 100 unites of intradetrusor onabotulinumtoxinA or placebo during surgery. Participants completed the PGI-S (Patient Global Impression of Severity), the UDI-6 (Urinary Distress Inventory, Short Form), and the PFIQ-7 (Pelvic Floor Impact Questionnaire-Short Form 7) before and 3 months after surgery, and the primary outcome, PGI-I (Patient Global Impression of Improvement), 3 months postoperatively. Primary outcome was PGI-I score at 3 months for overall incontinence. We considered women ""improved"" with answers of ""very much better"" or ""much better"" on the PGI-I. Assuming a PGI-I response of ""improved"" in 66% of placebo and 93% of onabotulinumtoxinA participants, 68 women were needed to show a significant difference with 80% power at 0.05 significance level.
RESULTS
From March 2016 to November 2019, 78 women completed a 3-month follow-up (onabotulinumtoxinA: 41; placebo: 37). Mean age was 51 years (±10). On the PGI-I, the number who ""improved"" did not differ between groups at 3 months (83% vs 84%, P=1.0). The onabotulinumtoxinA group had less severe urgency symptoms as indicated by median urgency PGI-S scores (1 [interquartile range 1-2] vs 2 [interquartile range 1-3], P=.033) and greater improvement in urgency symptoms based on median urgency PGI-I score (1 [interquartile range 1-3] vs 2 [interquartile range 2-4], P=.028). At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups. Similarly, UDI-6 and PFIQ-7 scores did not differ between groups. More women in the onabotulinumtoxinA arm initiated intermittent self-catheterization, (3% placebo; 12% onabotulinumtoxinA, P=.20) and experienced urinary tract infections (5% placebo; 22% onabotulinumtoxinA, P=.051), but these did not differ statistically.
CONCLUSION
Concurrent intradetrusor onabotulinumtoxinA injection did not improve overall incontinence symptoms at 3 months compared with placebo among women with mixed urinary incontinence undergoing midurethral sling placement. Women with mixed urinary incontinence undergoing sling report significant improvement in overall incontinence symptoms, regardless of the addition of onabotulinumtoxinA injections, but those receiving concurrent onabotulinumtoxinA injections reported less urgency severity and greater improvement in urgency symptoms at 3 months.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT02678377.",2020,"At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups.","['women with mixed urinary incontinence, planning to undergo midurethral sling', 'Women with mixed urinary incontinence undergoing sling', 'From March 2016 to November 2019, 78 women completed a 3-month follow-up (onabotulinumtoxinA: 41', 'Mixed Urinary Incontinence', 'Mean age was 51 years (±10', 'women with mixed urinary incontinence undergoing midurethral sling placement']","['intradetrusor onabotulinumtoxinA or placebo', 'placebo', 'Concurrent Retropubic Midurethral Sling and OnabotulinumtoxinA', 'Concurrent intradetrusor onabotulinumtoxinA injection', 'retropubic midurethral sling combined with onabotulinumtoxinA', 'onabotulinumtoxinA']","['PGI-I score at 3 months for overall incontinence', 'urgency symptoms', 'median UDI-6, PFIQ-7, and PGI-S scores', 'urgency severity', 'PGI-S (Patient Global Impression of Severity), the UDI-6 (Urinary Distress Inventory, Short Form), and the PFIQ-7 (Pelvic Floor Impact Questionnaire-Short Form 7', 'urgency symptoms based on median urgency PGI-I score', 'urinary tract infections', 'severe urgency symptoms', 'UDI-6 and PFIQ-7 scores', 'overall incontinence symptoms', 'median urgency PGI-S scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C2719767', 'cui_str': 'OnabotulinumtoxinA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0523816', 'cui_str': 'Pepsinogen I measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4720882', 'cui_str': 'Patient global impression of severity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",68.0,0.725035,"At 3 months, median UDI-6, PFIQ-7, and PGI-S scores improved significantly from baseline in both groups.","[{'ForeName': 'Alix', 'Initials': 'A', 'LastName': 'Komar', 'Affiliation': 'Department of Obstetrics and Gynecology, the Division of Female Pelvic Medicine and Reconstructive Surgery, and the Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Bretschneider', 'Affiliation': ''}, {'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'Mueller', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lewicky-Gaupp', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Geynisman-Tan', 'Affiliation': ''}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Tavathia', 'Affiliation': ''}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kenton', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004198']
2689,33278235,The Effect of Eye Drops and Applanation Tonometry on Optical Biometry.,"PURPOSE
This study aimed to determine if eye drops (phenylephrine, tropicamide, and fluorescein-proparacaine) and Goldmann applanation tonometry (GAT) have an effect on optical biometry measurements for pre-operative cataract surgery workup.
SETTING
George Washington University, Department of Ophthalmology DESIGN:: This study was a non-randomized control trial METHODS:: Participants over age 18 with no contraindications to eye drops or tonometry were recruited. Optical biometry measurements were obtained on a single eye using the Lenstar LS900. One drop each of phenylephrine, tropicamide, and fluorescein-proparacaine was applied to the same eye and measurements were repeated. GAT was performed, and measurements were repeated. For control subjects, the contralateral eye was also measured at each interval.
RESULTS
There was no statistically significant difference in mean predicted post-operative refraction (PPOR) K1, K2, or axis post-drops and post-GAT (n = 62). After drops were applied, mean central corneal thickness increased from 540 to 542 (P = 0.0002), mean anterior chamber depth (ACD) increased from 3.68 mm to 3.70 mm (P < 0.0001), and lens thickness decreased from 3.66 to 3.65 (P = 0.001). After GAT, anterior chamber depth increased to 3.76 mm (P < 0.0001) and lens thickness increased to 3.60 mm (P < 0.0001). There was no statistically significant difference in PPOR or other parameters for the control eyes (n=5).
CONCLUSIONS
GAT and phenylephrine, tropicamide, and fluorescein-proparacaine drops did not affect the primary outcome of PPOR. This suggests that cataract surgery candidates do not need to return for a separate pre-operative visit for optical biometry.",2020,"After drops were applied, mean central corneal thickness increased from 540 to 542 (P = 0.0002), mean anterior chamber depth (ACD) increased from 3.68 mm to 3.70 mm (P < 0.0001), and lens thickness decreased from 3.66 to 3.65 (P = 0.001).","[' Participants over age 18 with no contraindications to eye drops or tonometry were recruited', 'George Washington University, Department of Ophthalmology DESIGN']","['GAT and phenylephrine, tropicamide, and fluorescein-proparacaine', 'phenylephrine, tropicamide, and fluorescein-proparacaine', 'eye drops (phenylephrine, tropicamide, and fluorescein-proparacaine) and Goldmann applanation tonometry (GAT', 'Eye Drops and Applanation Tonometry']","['mean anterior chamber depth (ACD', 'anterior chamber depth', 'mean central corneal thickness', 'PPOR', 'mean predicted post-operative refraction (PPOR) K1, K2, or axis post-drops and post-GAT', 'lens thickness']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C1300251', 'cui_str': 'Goldmann applanation tonometry'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0041190', 'cui_str': 'Tropicamide'}, {'cui': 'C0016314', 'cui_str': 'Fluoresceins'}, {'cui': 'C0072510', 'cui_str': 'proparacaine'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0430862', 'cui_str': 'Applanation tonometry'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429492', 'cui_str': 'Depth of anterior chamber'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1300251', 'cui_str': 'Goldmann applanation tonometry'}, {'cui': 'C1299693', 'cui_str': 'Lens thickness'}]",,0.115176,"After drops were applied, mean central corneal thickness increased from 540 to 542 (P = 0.0002), mean anterior chamber depth (ACD) increased from 3.68 mm to 3.70 mm (P < 0.0001), and lens thickness decreased from 3.66 to 3.65 (P = 0.001).","[{'ForeName': 'Zacharia', 'Initials': 'Z', 'LastName': 'Nayer', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Bhat', 'Affiliation': 'Department of Ophthalmology at The George Washington University.'}, {'ForeName': 'Preet K', 'Initials': 'PK', 'LastName': 'Sohal', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Braedon', 'Initials': 'B', 'LastName': 'Murdock', 'Affiliation': 'George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Shelly H', 'Initials': 'SH', 'LastName': 'Watson', 'Affiliation': 'Department of Ophthalmology at The George Washington University.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Belyea', 'Affiliation': 'Department of Ophthalmology at The George Washington University.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000499']
2690,33278175,Coronary bifurcations treated with thin-strut drug-eluting stents: a prespecified analysis of the randomized BIO-RESORT trial.,"BACKGROUND
Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce.
METHODS
Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm.
RESULTS
Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique.
CONCLUSIONS
Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.",2021,There was no between-stent difference in individual components of target vessel failure.,"['all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm', '1236 patients were treated in bifurcation lesions and analyzed', '3514 all-comer patients']","['biodegradable polymer and durable polymer drug-eluting stents', 'very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents', 'Coronary bifurcations treated with thin-strut drug-eluting stents']","['individual components of target vessel failure', 'vessel failure', 'vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",1236.0,0.0772008,There was no between-stent difference in individual components of target vessel failure.,"[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Warta', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede.'}, {'ForeName': 'Liefke C', 'Initials': 'LC', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hartmann', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente.'}]",Coronary artery disease,['10.1097/MCA.0000000000000891']
2691,33278171,"Response to Comment on ""Randomized Comparison of Gastric Tube Reconstruction with and without Duodenal Diversion Plus Roux-en-Y Anastomosis after Esophagectomy"" by Dr Ahmed et al.",,2020,,[],['Gastric Tube Reconstruction with and without Duodenal Diversion Plus Roux-en-Y Anastomosis'],[],[],"[{'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}]",[],,0.0165835,,"[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan Department of Surgery, Osaka Prefectural General Medical Center, Osaka, Japan Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': ''}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': ''}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Sakon', 'Affiliation': ''}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Motoori', 'Affiliation': ''}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004660']
2692,33278170,"Response to Comment on ""Randomized Comparison of Gastric Tube Reconstruction with and Without Duodenal Diversion Plus Roux-en-Y Anastomosis after Esophagectomy"" by Dr Prakash et al.",,2020,,[],['Gastric Tube Reconstruction with and Without Duodenal Diversion Plus Roux-en-Y Anastomosis'],[],[],"[{'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}]",[],,0.0171396,,"[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan Department of Surgery, Osaka Prefectural General Medical Center, Osaka, Japan Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': ''}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Motoori', 'Affiliation': ''}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': ''}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': ''}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': ''}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Sakon', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004659']
2693,33271633,Early Use of Continuous Glucose Monitoring in Children and Adolescents After Total Pancreatectomy with Islet Autotransplantation.,"BACKGROUND
Children undergoing total pancreatectomy with islet autotransplantation (TPIAT) for chronic pancreatitis require intensive insulin therapy early after TPIAT with narrow glycemic targets, which can present significant care burden. Outpatient use of continuous glucose monitoring (CGM) systems by children and caregivers early after TPIAT is inadequately studied.
METHODS
In this open-label study, we randomized 14 children and adolescents (mean age 15.4 years) after hospital discharge for TPIAT to Dexcom G6 CGM (n=7) or standard care with a glucometer (n=7) to assess acceptability and glycemic control with use of CGM versus usual care (glucometer). Participants in the control arm also wore a blinded CGM for one week.
RESULTS
Children randomized to real-time CGM had lower mean sensor glucose values compared with controls (P=0.002), and high overall satisfaction with CGM.
CONCLUSIONS
Our data indicate that CGM is a useful adjunct to diabetes management for children who have recently undergone TPIAT. This article is protected by copyright. All rights reserved.",2020,"RESULTS
Children randomized to real-time CGM had lower mean sensor glucose values compared with controls (P=0.002), and high overall satisfaction with CGM.
","['Children and Adolescents', 'children and caregivers early after TPIAT is inadequately studied', 'children who have recently undergone TPIAT', '14 children and adolescents (mean age 15.4\u2009years) after hospital discharge for TPIAT to Dexcom G6 CGM (n=7) or standard care with a glucometer (n=7) to assess acceptability and glycemic control with use of', 'Children undergoing total pancreatectomy with']","['islet autotransplantation (TPIAT', 'CGM versus usual care (glucometer', 'CGM', 'continuous glucose monitoring (CGM) systems', 'Continuous Glucose Monitoring']",['mean sensor glucose values'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517579', 'cui_str': '15.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0040511', 'cui_str': 'Total pancreatectomy'}]","[{'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",14.0,0.0414423,"RESULTS
Children randomized to real-time CGM had lower mean sensor glucose values compared with controls (P=0.002), and high overall satisfaction with CGM.
","[{'ForeName': 'Kendall R', 'Initials': 'KR', 'LastName': 'McEachron', 'Affiliation': 'University of Minnesota Medical School Department of Surgery.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Potlapalli', 'Affiliation': 'University of Minnesota Medical School Department of Surgery.'}, {'ForeName': 'Arpana', 'Initials': 'A', 'LastName': 'Rayannavar', 'Affiliation': 'University of Minnesota Medical School Department of Pediatrics.'}, {'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Downs', 'Affiliation': 'University of Minnesota Medical School Department of Pediatrics.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Schwarzenberg', 'Affiliation': 'University of Minnesota Medical School Department of Pediatrics.'}, {'ForeName': 'Varvara A', 'Initials': 'VA', 'LastName': 'Kirchner', 'Affiliation': 'University of Minnesota Medical School Department of Surgery.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Beilman', 'Affiliation': 'University of Minnesota Medical School Department of Surgery.'}, {'ForeName': 'Srinath', 'Initials': 'S', 'LastName': 'Chinnakotla', 'Affiliation': 'University of Minnesota Medical School Department of Surgery.'}, {'ForeName': 'Melena D', 'Initials': 'MD', 'LastName': 'Bellin', 'Affiliation': 'University of Minnesota Medical School Department of Surgery.'}]",Pediatric diabetes,['10.1111/pedi.13168']
2694,33271604,"The ""diagnose and leave in"" strategy"" for diminutive rectosigmoid polyps in Lynch syndrome: a post-hoc analysis from a randomized controlled trial.","BACKGROUND AND STUDY AIM
The 'diagnose-and-leave-in' policy has been established to reduce risks and costs related to unnecessary polypectomies in the average-risk population. In Lynch syndrome individuals, due to accelerated carcinogenesis, the general recommendation is to remove all polyps, irrespective of size, location and appearance. We evaluated the feasibility and safety of the 'diagnose-and-leave-in' strategy in Lynch syndrome individuals.
PATIENTS AND METHODS
We performed a post-hoc analysis based on per-polyp data from a randomized, clinical trial conducted by 24 dedicated colonoscopists at 14 academic centres, in which 256 individuals with confirmed Lynch syndrome underwent surveillance colonoscopy from July 2016 to January 2018. In vivo optical diagnosis with the level of confidence of all detected lesions were obtained before polypectomy using virtual chromoendoscopy alone or with dye-based chromoendoscopy. Our primary outcome was the negative predictive value (NPV) for neoplasia of high-confidence optical diagnosis among diminutive (≤ 5 mm) rectosigmoid lesions. Histology was the reference standard.
RESULTS
Of 147 rectosigmoid lesions, 128 were diminutive. In 103 of the 128 lesions (81%) , the optical diagnostic confidence was high, showing a NPV of 96.0% (95% confidence interval, [88.9%-98.6%]) and accuracy of 89.3% (95% confidence interval, [81.9%-93.9%]). By following the 'diagnose-and-leave-in"" policy, we would have avoided 59% (75/128) unnecessary polypectomies at expenses of 2 diminutive low-grade dysplasia adenomas and 1 diminutive sessile serrated lesion that would have been left in situ.
CONCLUSION
In Lynch syndrome patients, the ""diagnose-and-leave-in strategy"" for diminutive rectosigmoid polyps would be feasible and safe.",2020,"In 103 of the 128 lesions (81%) , the optical diagnostic confidence was high, showing a NPV of 96.0% (95% confidence interval, [88.9%-98.6%]) and accuracy of 89.3% (95% confidence interval, [81.9%-93.9%]).","['Lynch syndrome individuals', '24 dedicated colonoscopists at 14 academic centres, in which 256 individuals with confirmed Lynch syndrome underwent surveillance colonoscopy from July 2016 to January 2018', 'Of 147 rectosigmoid lesions, 128 were diminutive']",['virtual chromoendoscopy alone or with dye-based chromoendoscopy'],"['negative predictive value (NPV) for neoplasia of high-confidence optical diagnosis', 'optical diagnostic confidence']","[{'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0521377', 'cui_str': 'Rectosigmoid structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",256.0,0.279582,"In 103 of the 128 lesions (81%) , the optical diagnostic confidence was high, showing a NPV of 96.0% (95% confidence interval, [88.9%-98.6%]) and accuracy of 89.3% (95% confidence interval, [81.9%-93.9%]).","[{'ForeName': 'Liseth', 'Initials': 'L', 'LastName': 'Rivero-Sánchez', 'Affiliation': 'Hospital Clinic de Barcelona, Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Aleksandar', 'Initials': 'A', 'LastName': 'Gavric', 'Affiliation': 'University Medical Centre Ljubljana, Department of Gastroenterology and Hepatology, Ljubljana, Slovenia.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Herrero', 'Affiliation': 'Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Biomédica Galicia Sur, CIBERehd, Gastroenterology, Ourense, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Remedios', 'Affiliation': 'Complexo Hospitalario Universitario de Ourense, Instituto de Investigación Biomédica Galicia Sur, CIBERehd, Gastroenterology, Ourense, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Alvarez', 'Affiliation': 'Complexo Hospitalario de Pontevedra, Digestive, Pontevedra, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Albéniz', 'Affiliation': 'Complejo Hospitalario de Navarra, Digestive System Service, Endoscopy Unit., Pamplona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gordillo', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Ignasi', 'Initials': 'I', 'LastName': 'Puig', 'Affiliation': 'Althaia, Xarxa Assistencial Universitària de Manresa, Gastroenterology, Manresa, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'López-Vicente', 'Affiliation': 'Hospital Universitario de Móstoles, Digestive System Service, Móstoles, Spain.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Huerta', 'Affiliation': 'Hospital Galdakao-Usansolo, Gastroenterology, Galdakao, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'López-Cerón', 'Affiliation': 'Hospital Universitario 12 de Octubre, Digestive System Service, Madrid, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Salces', 'Affiliation': 'Hospital Universitario 12 de Octubre, Digestive System Service, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Peñas', 'Affiliation': 'Hospital Universitario Ramon y Cajal, Gastroenterology, Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Parejo', 'Affiliation': 'Hospital Universitario Ramon y Cajal, Gastroenterology, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Rodriguez', 'Affiliation': 'Hospital Universitario Ramon y Cajal, Department of Gastroenterology, Madrid, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Herraiz Bayod', 'Affiliation': 'University of Navarra Clinic-IdiSNA, Gastroenterology, Pamplona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Carretero', 'Affiliation': 'University of Navarra Clinic-IdiSNA, Gastroenterology, Pamplona, Spain.'}, {'ForeName': 'Antonio Z', 'Initials': 'AZ', 'LastName': 'Gimeno Garcia', 'Affiliation': 'Hospital Universitario de Canarias, Gastroenterology, Santa Cruz de Tenerife, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Saperas', 'Affiliation': 'Hospital Universitari General de Catalunya, Gastroenterology, Sant Cugat del Vallès, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Hospital del Mar, Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Coral', 'Initials': 'C', 'LastName': 'Arnau-Collell', 'Affiliation': ""5. Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS)., ., Barcelona, Spain.""}, {'ForeName': 'Oswaldo', 'Initials': 'O', 'LastName': 'Ortiz', 'Affiliation': 'Hospital Clinic de Barcelona, Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Sánchez', 'Affiliation': 'Hospital Clinic de Barcelona, Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Jung', 'Affiliation': 'Hospital Clínic de Barcelona, Gastroenterology Department, Barcelona, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Balaguer', 'Affiliation': 'Hospital Clínic Barcelona, Gastroenterology, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Pellisé', 'Affiliation': 'Hospital Clínic Barcelona, Gastroenterology, Barcelona, Spain.'}]",Endoscopy,['10.1055/a-1328-5405']
2695,33271562,Correlation of Vitamin D3 with the Expression of RORγt and Foxp3 mRNAs in the Peripheral Blood of Myasthenia Gravis Patients.,"OBJECTIVES
to investigate the expression levels of 1,25(OH)2D3 in the peripheral blood from patients with myasthenia gravis (MG) and to correlate levels with retinoid-related orphan receptor γt (RORγt) and forkhead or winged-helix transcription factor 3 (Foxp3) mRNA expression.
METHODS
Sixty-seven patients with MG were enrolled in the experimental group, and 50 normal subjects were selected as the control group. The expression levels of 1,25(OH)2D3 and RORγt and Foxp3 mRNAs were measured in the serum of the 2 patient groups and the relationship between factors were correlated with the severity score of MG. The relationship between the levels of 1,25(OH)2D3 and the relative expressions of RORγt and Foxp3 mRNAs was determined.
RESULTS
There were no differences between groups regarding patient's baseline data. 1,25(OH)2D3 and RORγt and Foxp3 mRNAs are differentially expressed in the MG group and the control group (p < 0.05). QMG score is negatively correlated with the expression level of peripheral blood 1,25(OH)2D3 and Foxp3 mRNA (r = -0.797, -0.543; p < 0.01) and positively correlated with the relative expression level of RORγt mRNA (r = 0.539; p < 0.01). 1,25(OH)2D3 expression level was negatively correlated with the relative expression of RORγt mRNA (r = -0.559; p < 0.01) and positively correlated with the relative expression of Foxp3 mRNA (r = 0.390; p < 0.01).
CONCLUSIONS
The levels of 1,25(OH)2D3 were shown to be lower in patients with MG compared to normal controls. The observed low levels of 1,25(OH)2D3 may lead to changes in the expression of RORγt and Foxp3 mRNAs involved in MG.",2020,"The expression levels of 1,25(OH)2D3 and RORγt and Foxp3 mRNAs were measured in the serum of the 2 patient groups and the relationship between factors were correlated with the severity score of MG.","['Sixty-seven patients with MG were enrolled in the experimental group, and 50 normal subjects were selected as the control group', 'Myasthenia Gravis Patients', 'patients with myasthenia gravis (MG']",['Vitamin D3'],"['1,25(OH)2D3 expression level', 'levels of 1,25(OH)2D3', 'relative expression of Foxp3 mRNA', '1,25(OH)2D3 and RORγt and Foxp3 mRNAs', 'relative expression of RORγt mRNA', 'relative expression level of RORγt mRNA', 'expression level of peripheral blood 1,25(OH)2D3 and Foxp3 mRNA', 'QMG score', 'expression levels of 1,25(OH)2D3 and RORγt and Foxp3 mRNAs']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",67.0,0.0209764,"The expression levels of 1,25(OH)2D3 and RORγt and Foxp3 mRNAs were measured in the serum of the 2 patient groups and the relationship between factors were correlated with the severity score of MG.","[{'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': ""Department of Neurology, People's Hospital of Deyang City, DeYang, China.""}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'He', 'Affiliation': 'Department of Neurology, The Affiliated Hospital of Southwest Medical University, DeYang, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Department of Neurology, The second People's Hospital of Deyang City, Luzhou City, China, 782067723@qq.com.""}]",Neuroimmunomodulation,['10.1159/000510861']
2696,33271536,The Effectiveness of an Active Learning Program in Promoting a Healthy Lifestyle among Older Adults with Low Health Literacy: A Randomized Controlled Trial.,"BACKGROUND
Older adults often have a greater need for health information and health care services because access to these helps them manage their health and the chronic conditions of aging. Therefore, low health literacy bears a special significance for the population of older adults.
OBJECTIVES
The aim of this study was to examine the effects of an active learning program on health literacy, lifestyle behaviors, physical function, and mental health among community-dwelling older adults with low health literacy.
METHODS
This single-blind, randomized controlled trial involved 60 participants aged ≥65 years with a low health literacy who were randomly assigned to an intervention (n = 30) or control (n = 30) group. Across 24 weeks, the intervention group attended weekly 90-min active learning program sessions, which involved exploratory learning, group work, and the self-planning of behavior changes that promote a healthy lifestyle. The control group attended a 90-min class, which was taught in accordance with the didactic teaching method. For both groups, the programs focused on the role of exercise, diet/nutrition, and cognitive activity for promoting health among older adults. The outcome measures were administered at baseline and week 24. Comprehensive health literacy (i.e., primary outcome) was assessed using the Health Literacy Scale-14. Lifestyle factors (i.e., physical activity, dietary variety, life-space mobility, and social network size), physical function, and depressive symptoms were measured. We used a linear mixed model to estimate the intervention effects in accordance with the intention-to-treat approach.
RESULTS
When compared to the control group, the intervention group demonstrated a significant improvement in communicative health literacy, step count, engagement in moderate-to-vigorous physical activity, dietary variety, life-space mobility, social network size, grip strength, gait speed, and depressive symptoms.
CONCLUSIONS
The active learning program can promote a healthy lifestyle and prevent functional decline among older adults who lack the confidence to engage in health communication.",2020,"When compared to the control group, the intervention group demonstrated a significant improvement in communicative health literacy, step count, engagement in moderate-to-vigorous physical activity, dietary variety, life-space mobility, social network size, grip strength, gait speed, and depressive symptoms.
","['older adults who lack the confidence to engage in health communication', 'older adults', 'community-dwelling older adults with low health literacy', 'Older Adults with Low Health Literacy', '60 participants aged ≥65 years with a low health literacy who were randomly assigned to an intervention (n = 30) or control (n = 30) group', 'Older adults']","['Active Learning Program', 'active learning program', '90-min active learning program sessions, which involved exploratory learning, group work, and the self-planning of behavior changes that promote a healthy lifestyle']","['Lifestyle factors (i.e., physical activity, dietary variety, life-space mobility, and social network size), physical function, and depressive symptoms', 'communicative health literacy, step count, engagement in moderate-to-vigorous physical activity, dietary variety, life-space mobility, social network size, grip strength, gait speed, and depressive symptoms', 'health literacy, lifestyle behaviors, physical function, and mental health', 'Comprehensive health literacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1512347', 'cui_str': 'Health Communication'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0243012', 'cui_str': 'Active Learning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",60.0,0.0755751,"When compared to the control group, the intervention group demonstrated a significant improvement in communicative health literacy, step count, engagement in moderate-to-vigorous physical activity, dietary variety, life-space mobility, social network size, grip strength, gait speed, and depressive symptoms.
","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Uemura', 'Affiliation': 'Center for Liberal Arts and Sciences, Faculty of Engineering, Toyama Prefectural University, Imizu, Japan, kuemura@pu-toyama.ac.jp.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': 'Center for Liberal Arts and Sciences, Faculty of Engineering, Toyama Prefectural University, Imizu, Japan.'}]",Gerontology,['10.1159/000511357']
2697,33271394,Prediction of sublingual immunotherapy efficacy in allergic rhinitis by serum metabolomics analysis.,"BACKGROUND
Allergen-specific immunotherapy (ASIT) is currently the only therapy for allergic rhinitis (AR) that can induce immune tolerance to allergens. However, the course of ASIT is long and there is no objective biomarker to predict treatment efficacy. The present study aimed to explore potential biomarkers predictive of efficacy of AIT based on serum metabolomics profiles.
METHODS
This prospective study recruited 72 consecutive eligible patients who were assigned to receive sublingual immunotherapy (SLIT). Serum samples were collected prior to SLIT and utilized to obtain metabolomics profiling by applying ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS). Treatment response was determined 3 years after SLIT, and patients were divided into effective group and ineffective group. Orthogonal partial least square-discriminate analysis (OPLS-DA) was performed to evaluate the metabolite differences between two groups.
RESULTS
Sixty-eight patients completed the whole SLIT, 39 patients were categorized into effective group and 29 patients were classified into ineffective group. A total of 539 metabolites were obtained, and 197 of which were identified as known substances. Using these 197 known metabolites, the OPLS-DA results showed that effective group and ineffective group exhibited distinctive metabolite signatures and metabolic pathways. Six metabolites including lactic acid, ornithine, linolenic acid, creatinine, arachidonic acid and sphingosine were identified to exhibit good performance in predicting the efficacy of SLIT, and these metabolite changes mainly involved glycolysis and pyruvate metabolism, arginine and proline metabolism and fatty acid metabolism pathways.
CONCLUSION
By metabolomics analysis, we identified several serum biomarkers that can reliably and accurately predict the efficacy of SLIT in AR patients. The discriminative metabolites and related metabolic pathways contributed to better understand the mechanisms of SLIT in AR patients.",2020,"Using these 197 known metabolites, the OPLS-DA results showed that effective group and ineffective group exhibited distinctive metabolite signatures and metabolic pathways.","['72 consecutive eligible patients who were assigned to receive', 'AR patients', 'Sixty-eight patients completed the whole SLIT, 39 patients were categorized into effective group and 29 patients were classified into ineffective group', 'allergic rhinitis (AR']","['sublingual immunotherapy (SLIT', 'Allergen-specific immunotherapy (ASIT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C3658366', 'cui_str': 'Sublingual Immunotherapy'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]",[],539.0,0.0140521,"Using these 197 known metabolites, the OPLS-DA results showed that effective group and ineffective group exhibited distinctive metabolite signatures and metabolic pathways.","[{'ForeName': 'Shaobing', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Sijie', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Fengjun', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Yongzhen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Yongchuan', 'Initials': 'Y', 'LastName': 'She', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Changsha Hospital of Traditional Chinese Medicine, Changsha, Hunan, China.'}, {'ForeName': 'Qiancheng', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Changsha Central Hospital, University of South China, Changsha, Hunan, China.'}, {'ForeName': 'Kelei', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Ruohao', 'Initials': 'R', 'LastName': 'Fan', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Shumin', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China.'}, {'ForeName': 'Zhihai', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China. Electronic address: xiedoctor@csu.edu.cn.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Xiangya Hospital of Central South University, Changsha, Hunan, China; Hunan Province Key Laboratory of Otolaryngology Critical Diseases, Changsha, Hunan, China. Electronic address: jiangwh68@126.com.'}]",International immunopharmacology,['10.1016/j.intimp.2020.107211']
2698,33271376,Long-term outcomes following lumbar microendoscopic decompression for lumbar spinal stenosis with and without degenerative spondylolisthesis: Minimum 10-year follow-up.,"OBJECTIVE
To determine whether preoperative presence of degenerative lumbar spondylolisthesis (DS) worsens the minimum 10-year outcome of patients undergoing microendoscopic decompression (MED) for lumbar spinal stenosis (SS).
METHODS
Eighty patients undergoing MED were classified into two groups: DS group (34 SS with DS patients) and SS group (46 SS without DS patients). The degrees of improvement (DOIs) by the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) and intensities of improvement (IOIs) by visual analogue scale (VAS) at 120∼159 (mean, 138.4) months after MED of the DS and SS groups were statistically compared. Patients with DS were classified into two groups based on the effectiveness by VAS or JOABPEQ: effective group (E group: IOI or DOI ≥20) and ineffective group (I group). All preoperative radiological measurements were statistically compared between the E and I groups.
RESULTS
Significant decreases in low back pain (LBP), leg pain and numbness, as measured by VAS, were noted at follow-up in the DS and SS groups. The effectiveness rates of pain-related disorders, lumbar spine dysfunction, and gait disturbance by JOABPEQ were almost equally high in the DS and SS groups. Statistical comparisons of the DOIs in all five functional scores and IOIs in LBP, leg pain and numbness showed no significant differences between the DS and SS groups. No significant differences were confirmed between the E and I groups concerning preoperative spondylolisthesis and instability.
CONCLUSIONS
Our study indicated that preoperative DS did not worsen the outcome of patients with SS undergoing MED.",2020,"RESULTS
Significant decreases in low back pain (LBP), leg pain and numbness, as measured by VAS, were noted at follow-up in the DS and SS groups.","['lumbar spinal stenosis with and without degenerative spondylolisthesis', 'Patients with DS', 'patients with SS undergoing MED', 'patients undergoing microendoscopic decompression (MED) for lumbar spinal stenosis (SS', 'Eighty patients undergoing MED were classified into two groups: DS group (34 SS with DS patients) and SS group (46 SS without DS patients']","['lumbar microendoscopic decompression', 'VAS or JOABPEQ', 'degenerative lumbar spondylolisthesis (DS']","['functional scores and IOIs in LBP, leg pain and numbness', 'Back Pain Evaluation Questionnaire (JOABPEQ) and intensities of improvement (IOIs) by visual analogue scale (VAS', 'effectiveness rates of pain-related disorders, lumbar spine dysfunction, and gait disturbance by JOABPEQ', 'low back pain (LBP), leg pain and numbness, as measured by VAS', 'preoperative spondylolisthesis and instability']","[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0264184', 'cui_str': 'Degenerative spondylolisthesis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0746025', 'cui_str': 'Lumbar spondylolisthesis'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0746025', 'cui_str': 'Lumbar spondylolisthesis'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0575081', 'cui_str': 'Abnormal gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0038016', 'cui_str': 'Spondylolisthesis'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]",80.0,0.012043,"RESULTS
Significant decreases in low back pain (LBP), leg pain and numbness, as measured by VAS, were noted at follow-up in the DS and SS groups.","[{'ForeName': 'Takato', 'Initials': 'T', 'LastName': 'Aihara', 'Affiliation': 'Department of Orthopedic Surgery, Funabashi Orthopedic Hospital, Muroran, Japan; Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan. Electronic address: aihara@fff.or.jp.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Endo', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kojima', 'Affiliation': 'Department of Orthopedic Surgery, Funabashi Orthopedic Hospital, Muroran, Japan.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Sawaji', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Urushibara', 'Affiliation': 'Department of Orthopedic Surgery, Funabashi Orthopedic Hospital, Muroran, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Taichiro', 'Initials': 'T', 'LastName': 'Takamatsu', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Murata', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Takamitsu', 'Initials': 'T', 'LastName': 'Konishi', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hideya', 'Initials': 'H', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Endo', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Orthopedic Surgery, Tokyo Medical University, Tokyo, Japan.'}]",World neurosurgery,['10.1016/j.wneu.2020.11.131']
2699,33271352,"A Randomised Phase III Trial of Palliative Radiotherapy (PRT) versus Concurrent Chemotherapy and PRT (C-PRT) in Patients with Good Performance Status, Locally Advanced or Metastatic NSCLC with symptoms due to intrathoracic disease who are not suitable for radical Chemo-radiotherapy: Results of the Trans-Tasman Radiation Oncology Group (TROG) 11.03 Trial.","PURPOSE
We compared intrathoracic symptom response rate, quality of life (QOL) and toxicity in patients with Non-small cell Lung cancer (NSCLC) not suitable for radical chemo-radiotherapy (C-RT), experiencing symptoms from intrathoracic disease, who were randomized to receive palliative radiation therapy (PRT 36/12 ) or concurrent chemotherapy and PRT (C-PRT 40/20 ).
METHODS AND MATERIALS
We included patients with stage III or IV NSCLC, Eastern Co-operative Oncology Group (ECOG) Performance status 0-1, experiencing at least one of dyspnea, cough, hemoptysis or chest pain. The primary outcome was a change in intrathoracic response rate from baseline to six weeks post completion of therapy using (1) a composite measure, the Intrathoracic Symptom Burden Index (ISBI) and (2) individual symptom scores measured by the EORTC QLQ-C30 and QLQ-LC 13 instruments.
RESULTS
76 patients were recruited with 68 eligible for analysis. 42.6% and 57.4% had stage III and IV disease respectively. The ISBI was significantly lower at 6 weeks post treatment than at baseline (adjusted mean difference -8.77, SE 2.67, 95%CI [-13.97, -3.58], p<0.01) for the entire cohort with no difference between trial arms (p=0.34). Both treatments provided effective palliation of individual symptoms with no significant difference between trial arms. QOL during treatment was significantly better for patients receiving C-PRT (40/20) . There was no difference between arms in overall QOL between baseline and 6 weeks post treatment. There was no difference in toxicity between treatment arms during treatment nor between baseline and 6 weeks post treatment. There was no difference in progression-free survival (PFS). A non-statistically significant 3month improvement in median survival favored C-PRT (40/20) .
CONCLUSION
PRT (36/12) and C-PRT (40/20) provide effective symptom palliation in patients with stage III NSCLC not suitable for radical C-RT and in patients with Stage IV disease. Chemotherapy added to PRT (40/20) does not provide superior symptomatic relief in this patient cohort .",2020,"The ISBI was significantly lower at 6 weeks post treatment than at baseline (adjusted mean difference -8.77, SE 2.67, 95%CI [-13.97, -3.58], p<0.01) for the entire cohort with no difference between trial arms (p=0.34).","['We included patients with stage III or IV NSCLC, Eastern Co-operative Oncology Group (ECOG', 'patients with Non-small cell Lung cancer (NSCLC) not suitable for radical chemo-radiotherapy (C-RT), experiencing symptoms from intrathoracic disease', '76 patients were recruited with 68 eligible for analysis', 'Patients with Good Performance Status, Locally Advanced or Metastatic NSCLC with symptoms due to intrathoracic disease who are not suitable for', 'patients with stage III NSCLC not suitable for radical C-RT and in patients with Stage IV disease']","['radical Chemo-radiotherapy', 'Chemotherapy added to PRT', 'Palliative Radiotherapy (PRT', 'PRT', 'palliative radiation therapy (PRT 36/12 ) or concurrent chemotherapy and PRT (C-PRT 40/20 ', 'Concurrent Chemotherapy and PRT (C-PRT']","['ISBI', 'Performance status 0-1, experiencing at least one of dyspnea, cough, hemoptysis or chest pain', 'QOL', 'intrathoracic symptom response rate, quality of life (QOL) and toxicity', 'median survival', 'change in intrathoracic response rate', 'toxicity', 'Intrathoracic Symptom Burden Index (ISBI) and (2) individual symptom scores measured by the EORTC QLQ-C30 and QLQ-LC 13 instruments', 'progression-free survival (PFS', 'overall QOL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}]","[{'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0020687', 'cui_str': 'Hypoxanthine phosphoribosyltransferase'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0019079', 'cui_str': 'Hemoptysis'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",76.0,0.211535,"The ISBI was significantly lower at 6 weeks post treatment than at baseline (adjusted mean difference -8.77, SE 2.67, 95%CI [-13.97, -3.58], p<0.01) for the entire cohort with no difference between trial arms (p=0.34).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lehman', 'Affiliation': 'Department of Radiation Oncology, Princess Alexandra Hospital (Ipswich Road), Brisbane, Australia; University of Queensland. Electronic address: Margot.Lehman@health.qld.gov.au.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': 'QCIF Facility for Advanced Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, QLD, Australia. Electronic address: a.bernard@qfab.org.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'See', 'Affiliation': 'Cancer Trials Unit, Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'The University of Sydney, Faculty of Science, School of Psychology, Sydney Quality of Life Office, Sydney, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Michael', 'Affiliation': 'The Sir Peter MacCallum Department of Oncology, Melbourne, Australia; The University of Melbourne, Melbourne, Australia.'}]",Practical radiation oncology,['10.1016/j.prro.2020.11.009']
2700,33271319,Oral Dydrogesterone vs. Micronized Vaginal Progesterone Gel for Luteal Phase Support in Frozen-Thawed Single Blastocyst Transfer in Good Prognosis Patients.,"OBJECTIVE
To investigate the efficacy of oral dydrogesterone for luteal phase support (LPS) in modified natural cycle frozen-thawed embryo transfers (mNC-FET) compared to micronized vaginal progesterone (MVP) gel.
METHODS
This was a randomized, single-center, parallel controlled trial conducted at an ART and Reproductive Genetics Centre within a private hospital between January and August 2019. A total of 134 women, aged below 38, were assigned randomly to receive oral dydrogesterone (n = 67) or MVP (n = 67) for LPS in mNC-FET. The primary outcome was ongoing pregnancy rate (OPR) and secondary outcomes were clinical pregnancy and miscarriage rates, patients' satisfaction and tolerability of oral and vaginal progesterone. A questionnaire was developed to compare patient satisfaction and side effect profiles.
RESULTS
There was no significant difference in demographic features such as female age, body mass index, AMH levels and fresh cycle characteristics between two groups (p > 0.05). When mNC-FET outcomes were compared, OPR was 68.7% in MVP gel group and 71.6% in the dydrogesterone group respectively percentage difference, -2.99; 95% CI: -17.96, 13.10) Biochemical and clinical pregnancy rates and biochemical and clinical miscarriage rates were also similar between two groups. A significantly higher patient tolerability score was present in the dydrogesterone arm (4,13 ± 0,97 vs 3,43 ± 1,17, p = 0.001).
CONCLUSION
Our results suggest that oral dydrogesterone provides similar ongoing pregnancy rates compared to MVP gel as a LPS in mNC FET. Since dydrogesterone is an effective and easy-to-use option with fewer intolerable side effects including vaginal irritation, vaginal discharge, and preventing sexual intercourse, it can be used as LPS in mNC FET.",2020,"There was no significant difference in demographic features such as female age, body mass index, AMH levels and fresh cycle characteristics between two groups (p > 0.05).","['A total of 134 women, aged below 38', 'Good Prognosis Patients', 'ART and Reproductive Genetics Centre within a private hospital between January and August 2019']","['Oral Dydrogesterone vs. Micronized Vaginal Progesterone Gel', 'MVP', 'MVP gel', 'LPS in mNC-FET', 'micronized vaginal progesterone (MVP) gel', 'oral dydrogesterone', 'modified natural cycle frozen-thawed embryo transfers (mNC-FET', 'dydrogesterone']","['patient satisfaction and side effect profiles', 'demographic features such as female age, body mass index, AMH levels and fresh cycle characteristics', 'OPR', 'pregnancy rates', 'patient tolerability score', ""ongoing pregnancy rate (OPR) and secondary outcomes were clinical pregnancy and miscarriage rates, patients' satisfaction and tolerability of oral and vaginal progesterone"", 'Biochemical and clinical pregnancy rates and biochemical and clinical miscarriage rates']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0278250', 'cui_str': 'Prognosis good'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033173', 'cui_str': 'Private hospital'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0162874', 'cui_str': 'Amharic language'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",134.0,0.10901,"There was no significant difference in demographic features such as female age, body mass index, AMH levels and fresh cycle characteristics between two groups (p > 0.05).","[{'ForeName': 'Gonul', 'Initials': 'G', 'LastName': 'Ozer', 'Affiliation': 'Istanbul Memorial Hospital IVF and Reproductive Genetics Centre, 34385, Sisli, Istanbul, Turkey. Electronic address: drgonulozer@gmail.com.'}, {'ForeName': 'Kadriye Beril', 'Initials': 'KB', 'LastName': 'Yuksel', 'Affiliation': 'Istanbul Memorial Hospital IVF and Reproductive Genetics Centre, 34385, Sisli, Istanbul, Turkey.'}, {'ForeName': 'Ozge Senem', 'Initials': 'OS', 'LastName': 'Yucel Cicek', 'Affiliation': 'Kocaeli University Faculty of Medicine, Department of Obstetrics and Gynecology, 41380, İzmit, Kocaeli, Turkey.'}, {'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Kahraman', 'Affiliation': 'Istanbul Memorial Hospital IVF and Reproductive Genetics Centre, 34385, Sisli, Istanbul, Turkey.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.102030']
2701,33278020,Metabolic Effects of Aripiprazole and Olanzapine Multiple-Dose Treatment in a Randomised Crossover Clinical Trial in Healthy Volunteers: Association with Pharmacogenetics.,"INTRODUCTION
Aripiprazole and olanzapine are atypical antipsychotics. Both drugs can induce metabolic changes; however, the metabolic side effects produced by aripiprazole are more benign. The aim of the study was to evaluate if aripiprazole and olanzapine alter prolactin levels, lipid and glucose metabolism and hepatic, haematological, thyroid and renal function.
METHODS
Twenty-four healthy volunteers received a daily oral dose of 10 mg aripiprazole and 5 mg olanzapine tablets for 5 days in a crossover randomised clinical trial and were genotyped for 51 polymorphisms in 18 genes by qPCR. Drug plasma concentrations were measured by LC-MS. The biochemical and haematological analyses were performed by enzymatic methods.
RESULTS
Olanzapine induced hyperprolactinaemia but aripiprazole did not. Dopamine D3 receptor (DRD3) Ser/Gly and ATP binding cassette subfamily B member 1 (ABCB1) rs10280101, rs12720067 and rs11983225 polymorphisms and cytochrome P450 3A (CYP3A) phenotype had an impact on plasma prolactin levels. C-peptide concentrations were higher after aripiprazole administration and were influenced by catechol-O-methyltransferase (COMT) rs4680 and rs13306278 polymorphisms. Olanzapine and the UDP glucuronosyltransferase family 1 member A1 (UGT1A1) rs887829 polymorphism were associated with elevated glucose levels. CYP3A poor metabolizers had increased insulin levels. Volunteers' weight decreased significantly during aripiprazole treatment and a tendency for weight gain was observed during olanzapine treatment. Triglyceride concentrations decreased as a result of olanzapine and aripiprazole treatment, and varied on the basis of CYP3A phenotypes and the apolipoprotein C-III (APOC3) rs4520 genotype. Cholesterol levels were also decreased and depended on 5-hydroxytryptamine receptor 2A (HTR2A) rs6314 polymorphism. All hepatic enzymes, platelet and albumin levels, and prothrombin time were altered during both treatments. Additionally, olanzapine reduced the leucocyte count, aripiprazole increased free T4 and both decreased uric acid concentrations.
CONCLUSIONS
Short-term treatment with aripiprazole and olanzapine had a significant influence on the metabolic parameters. However, it seems that aripiprazole provokes less severe metabolic changes.
TRIAL REGISTRATION
Clinical trial registration number (EUDRA-CT): 2018-000744-26.",2020,C-peptide concentrations were higher after aripiprazole administration and were influenced by catechol-O-methyltransferase (COMT) rs4680 and rs13306278 polymorphisms.,"['Twenty-four healthy volunteers', 'Healthy Volunteers']","['aripiprazole and olanzapine', 'UDP glucuronosyltransferase family\xa01 member\xa0A1 (UGT1A1', 'Aripiprazole and olanzapine', 'aripiprazole', 'Olanzapine', 'Aripiprazole and Olanzapine Multiple-Dose Treatment', 'aripiprazole and 5\xa0mg olanzapine tablets', 'olanzapine and aripiprazole', 'Dopamine D3 receptor', 'olanzapine']","['C-peptide concentrations', 'Drug plasma concentrations', 'All hepatic enzymes, platelet and albumin levels, and prothrombin time', 'leucocyte count, aripiprazole increased free T4 and both decreased uric acid concentrations', 'Triglyceride concentrations', 'elevated glucose levels', 'metabolic parameters', 'prolactin levels, lipid and glucose metabolism and hepatic, haematological, thyroid and renal function', 'insulin levels', 'weight gain', 'hyperprolactinaemia', ""Volunteers' weight"", 'Cholesterol levels', 'plasma prolactin levels']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0041560', 'cui_str': 'Glucuronosyltransferase'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1247204', 'cui_str': 'olanzapine Oral Tablet'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0948241', 'cui_str': 'Thyroxine free increased'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0020514', 'cui_str': 'Hyperprolactinemia'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C1277971', 'cui_str': 'Plasma prolactin measurement'}]",24.0,0.0173305,C-peptide concentrations were higher after aripiprazole administration and were influenced by catechol-O-methyltransferase (COMT) rs4680 and rs13306278 polymorphisms.,"[{'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Koller', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Almenara', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Mejía', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Saiz-Rodríguez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Zubiaur', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Román', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Ochoa', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Navares-Gómez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santos-Molina', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pintos-Sánchez', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Abad-Santos', 'Affiliation': 'Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, School of Medicine, Universidad Autónoma de Madrid, Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain. francisco.abad@salud.madrid.org.'}]",Advances in therapy,['10.1007/s12325-020-01566-w']
2702,33278016,Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2).,"PURPOSE
Ixekizumab is a high-affinity monoclonal antibody that selectively targets interleukin-17A. The objective of this study was to assess the long-term efficacy and safety (to week 156) of ixekizumab in patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors.
METHODS
In the SPIRIT-P2 study (ClinicalTrials.gov ID: NCT02349295), patients were randomized to placebo or ixekizumab 80 mg every 4 weeks (IXE Q4W) or every 2 weeks (IXE Q2W) following a 160-mg starting dose. During the extension period (weeks 24-156), patients maintained their original ixekizumab dose, and placebo patients received IXE Q4W or IXE Q2W (1:1). Exposure-adjusted incidence rates (IRs) per 100 patient-years (PY) are presented.
RESULTS
Of 363 patients enrolled in the study, 310 entered the extension period. In all patients treated with IXE Q4W and IXE Q2W at week 0, responses persisted to week 156. At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA. Placebo patients re-randomized to ixekizumab also demonstrated sustained efficacy, as measured by ACR and MDA responses. In the All Ixekizumab Exposure Safety Population (n = 337), with 644 PY of ixekizumab exposure, treatment-emergent adverse events (TEAEs) were reported by 286 patients (44.4 IR). The most common TEAEs were upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis (4.5 IR). Serious adverse events were reported by 42 (6.5 IR) patients (included 3 deaths and 10 infections).
CONCLUSION
In this 156-week study of ixekizumab, improvements in signs and symptoms of psoriatic arthritis and the safety profile remained consistent with those in previous reports.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02349295.",2020,"At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA.","['363 patients enrolled in the study', 'patients with active psoriatic arthritis and inadequate response or intolerance to one or two tumor necrosis factor inhibitors', 'Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors']","['80\xa0mg every 4\xa0weeks (IXE Q4W) or every 2\xa0weeks (IXE Q2W', 'placebo patients received IXE Q4W or IXE Q2W (1:1', 'placebo or ixekizumab', 'Ixekizumab', 'ixekizumab', 'IXE Q4W and IXE Q2W', 'Placebo', 'interleukin-17A']","['long-term efficacy and safety', 'assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity', 'signs and symptoms of psoriatic arthritis', 'upper respiratory tract infection (9.80 IR), nasopharyngitis (8.2 IR), sinusitis (6.2 IR), and bronchitis', 'Serious adverse events', 'ACR and MDA responses', 'Efficacy and Safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0006277', 'cui_str': 'Bronchitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",363.0,0.138668,"At week 156, clinical responses (observed) in patients treated with IXE Q4W and IXE Q2W were assessed [American College of Rheumatology (ACR) response criteria and minimal disease activity (MDA) criteria]: 84 and 85% showed 20% improvement (ACR20); 60 and 58% showed 50% improvement (ACR50); 35 and 47% showed 70% improvement (ACR70), respectively; and 48 and 54% showed MDA.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA. aorbai1@jhmi.edu.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Rheumatology Department, Hospital Universitari Parc Taulí, Sabadell, Barcelona, Spain.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Turkiewicz', 'Affiliation': 'Rheumatology Associates Clinical Research Unit, Birmingham, AL, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Dokoupilova', 'Affiliation': 'Medical Plus, s.r.o., Uherské Hradiště, Czech Republic.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'CHU Montpellier and Montpellier University, Montpellier, France.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'School of Medicine, Griffith University, Brisbane, Australia.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Clinton C', 'Initials': 'CC', 'LastName': 'Bertram', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Gellett', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Aubrey Trevelin', 'Initials': 'AT', 'LastName': 'Sprabery', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Birt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Macpherson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Vladimir J', 'Initials': 'VJ', 'LastName': 'Geneus', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Constantin', 'Affiliation': 'Hospital Pierre-Paul Riquet and Université Toulouse III, Toulouse, France.'}]",Rheumatology and therapy,['10.1007/s40744-020-00261-0']
2703,33278014,Evidence from a Randomized Controlled Trial that Altruism Moderates the Effect of Prosocial Acts on Adolescent Well-being.,"Despite growing public and scientific interest in the positive benefits of prosociality, there has been little research on the causal effects of performing kind acts for others on psychological well-being during adolescence. Developmental changes during adolescence, such as greater perspective taking, can promote prosociality. It was hypothesized that performing kind acts for others would improve adolescent well-being (positive and negative affect, perceived stress) and increase prosocial giving. As part of a randomized controlled trial, 97 adolescents (M age = 16.224, SD = 0.816, range 14-17; 53.608% female) were assigned to either perform kind acts for others (Kindness to Others, N = 33), perform kind acts for themselves (Kindness to Self, N = 34), or report on daily activities (Daily Report, N = 30) three times per week for four weeks. Well-being factors were measured weekly and giving was tested post-intervention. Overall, changes over time in well-being did not differ across conditions. However, altruism emerged as a significant moderator such that altruistic adolescents in the Kindness to Others condition showed increased positive affect, decreased negative affect, and decreased stress. Increased positive affect was also linked to greater prosocial giving for Kindness to Others adolescents. These findings identify individual differences that may shape the effects of doing kind acts for others on well-being during adolescence.",2020,"Overall, changes over time in well-being did not differ across conditions.","['97 adolescents (M age\u2009 =\u200916.224, SD\u2009=\u20090.816, range 14-17; 53.608% female', '30', 'Adolescent']","['Prosocial Acts', 'perform kind acts for themselves (Kindness to Self, N\u2009=\u200934), or report on daily activities (Daily Report, N\u2009']",['stress'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}]",97.0,0.0917603,"Overall, changes over time in well-being did not differ across conditions.","[{'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Tashjian', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA. smtashjian@ucla.edu.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Rahal', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Maira', 'Initials': 'M', 'LastName': 'Karan', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Galván', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles, CA, 90095, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fuligni', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, 90095, USA. afuligni@ucla.edu.'}]",Journal of youth and adolescence,['10.1007/s10964-020-01362-3']
2704,33277992,"Changes in hypertension control in a community-based population of older adults, 2011-2013 to 2016-2017.","BACKGROUND
The 2014 hypertension guideline raised treatment goals in older adults. The study objective was to examine changes in blood pressure (BP) control (<140/90 mmHg) from 2011-2013 to 2016-2017 among Black and white older adults with treated hypertension.
METHODS
Participants were 1600 white and 650 Black adults aged 71-90 years in the Atherosclerosis Risk in Communities (ARIC) Study with treated hypertension in 2011-2013 (baseline) who had BP measured in 2016-2017 (follow up). Factors associated with changes in BP control were examined by race.
RESULTS
BP was controlled among 75.3% of white and 65.7% of Black participants at baseline and 59.0% of white and 56.5% of Black participants at follow up. Among those with controlled BP at baseline, risk factors for incident uncontrolled BP included age (RR 1.15 per 5 years, 95% CI 1.07-1.25), female sex (RR 1.36, 95% CI 1.16-1.60), and chronic kidney disease (CKD) (RR 1.19, 95% CI 1.01-1.40) among white participants, and hypertension duration (RR 1.14 per 5 years, 95% CI 1.03-1.27) and diabetes (RR 1.48, 95% CI 1.15-1.91) among Black participants. Among those with uncontrolled BP at baseline, white females vs males (RR 0.60, 95% CI 0.46-0.78) and Black participants with CKD vs without (RR 0.58, 95% CI 0.36-0.93) were less likely to have incident controlled BP.
CONCLUSIONS
BP control decreased among white and Black older adults. Black individuals with diabetes or CKD were less likely to have controlled BP at follow up. Higher treatment goals may have contributed to these findings and unintended differences by race.",2020,"RESULTS
BP was controlled among 75.3% of white and 65.7% of Black participants at baseline and 59.0% of white and 56.5% of Black participants at follow up.","['2011-2013 to 2016-2017 among Black and white older adults with treated hypertension', 'Black individuals with diabetes or CKD', 'hypertension control in a community-based population of older adults, 2011-2013 to 2016-2017', 'older adults', 'Participants were 1600 white and 650 Black adults aged 71-90 years in the Atherosclerosis Risk in Communities (ARIC) Study with treated hypertension in 2011-2013 (baseline) who had BP measured in 2016-2017 (follow up', 'white and Black older adults']",[],"['BP', 'hypertension duration', 'chronic kidney disease (CKD', 'BP control', 'blood pressure (BP) control']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517592', 'cui_str': '1600'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",1600.0,0.0670298,"RESULTS
BP was controlled among 75.3% of white and 65.7% of Black participants at baseline and 59.0% of white and 56.5% of Black participants at follow up.","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Foti', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Kunihiro', 'Initials': 'K', 'LastName': 'Matsushita', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Koton', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Keenan A', 'Initials': 'KA', 'LastName': 'Walker', 'Affiliation': 'Laboratory of Behavioral Neuroscience, Intramural Research Program, National Institute on Aging, Baltimore, Maryland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Coresh', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Selvin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",American journal of hypertension,['10.1093/ajh/hpaa206']
2705,33277746,5-Year outcomes of the prospective and randomized cistcert study comparing steroid withdrawal to replacement of cyclosporine with everolimus in de novo kidney transplant patients.,"BACKGROUND
Withdrawal of either steroids or calcineurin inhibitors are two strategies to reduce treatment-related side effects and improve long-term outcomes of kidney transplantation. The Cistcert study compared the efficacy and safety of these two strategies.
METHODS
In this multi-center, randomized controlled trial, 151 incident kidney transplant recipients received cyclosporine (CsA), mycophenolic acid (MPA) and steroids during three months, followed by either steroid withdrawal (CsA/MPA) or replacement of cyclosporine with everolimus (EVL) (EVL/MPA/steroids).
RESULTS
Five-year patient (89% vs 86%; p=NS) and death-censored graft survival (95% vs 96%; p=NS) were comparable in the CsA/MPA and EVL/MPA/steroids arm respectively. 51 CrEDTA clearance was comparable in the intention-to-treat analysis, but in the on-treatment population, the EVL/MPA/steroids arm exhibited a superior 51 CrEDTA clearance at 1 and 5 years after transplantation (61.6 vs 52.4, p=0.05 and 59.1 vs 46.2mL/min/1.73 m 2 , p=0.042). Numerically more and more severe rejections were observed in the EVL/MPA/steroids arm, which also experienced a higher incidence of post-transplant diabetes (26% versus 6%, p=0.0016) and infections. No significant differences were observed in cardiovascular outcomes and malignancy.
CONCLUSIONS
Both regimens provide an excellent long-term patient and graft survival. Regarding graft function, EVL/MPA/steroids is an attractive strategy for patients with good tolerability who remain free of rejection.",2020,"RESULTS
Five-year patient (89% vs 86%; p=NS) and death-censored graft survival (95% vs 96%; p=NS) were comparable in the CsA/MPA and EVL/MPA/steroids arm respectively. ","['de novo kidney transplant patients', '151 incident kidney transplant recipients received', 'patients with good tolerability who remain free of rejection']","['steroids or calcineurin inhibitors', 'cyclosporine (CsA), mycophenolic acid (MPA) and steroids', 'cyclosporine with everolimus', 'steroid withdrawal (CsA/MPA) or replacement of cyclosporine with everolimus (EVL) (EVL/MPA/steroids']","['incidence of post-transplant diabetes', 'severe rejections', 'efficacy and safety', 'cardiovascular outcomes and malignancy', 'graft survival', 'death-censored graft survival']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}]","[{'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0026933', 'cui_str': 'Mycophenolic Acid'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",151.0,0.0818161,"RESULTS
Five-year patient (89% vs 86%; p=NS) and death-censored graft survival (95% vs 96%; p=NS) were comparable in the CsA/MPA and EVL/MPA/steroids arm respectively. ","[{'ForeName': 'Lissa', 'Initials': 'L', 'LastName': 'Pipeleers', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Abramowicz', 'Affiliation': 'Department of Nephrology, Centre Universitaire de Bruxelles - Hôpital Erasme, Brussels, Belgium.'}, {'ForeName': 'Nilufer', 'Initials': 'N', 'LastName': 'Broeders', 'Affiliation': 'Department of Nephrology, Centre Universitaire de Bruxelles - Hôpital Erasme, Brussels, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Lemoine', 'Affiliation': 'Department of Nephrology, Centre Universitaire de Bruxelles - Hôpital Erasme, Brussels, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Peeters', 'Affiliation': 'Renal Division, Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Van Laecke', 'Affiliation': 'Renal Division, Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Laurent E', 'Initials': 'LE', 'LastName': 'Weekers', 'Affiliation': 'Department of Nephrology, Centre Hospitalier Universitaire de Liège, Domaine Universitaire du Sart Tilman, Liège, Belgium.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Sennesael', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Karl M', 'Initials': 'KM', 'LastName': 'Wissing', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Geers', 'Affiliation': 'Department of Pathology, Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Bosmans', 'Affiliation': 'Department of Nephrology, Universitair Ziekenhuis Antwerpen, Antwerp, Belgium.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13798']
2706,33277736,A bundled phosphate control intervention (4Ds) for adults with end-stage kidney disease receiving haemodialysis: A cluster randomized controlled trial.,"AIM
To evaluate the effectiveness of a bundled self-management intervention (taking control of your phosphate with the 4Ds) to improve phosphate control among adults receiving haemodialysis.
BACKGROUND
Hyperphosphataemia occurs in end-stage kidney disease and is managed by diet, drinks, drugs (phosphate binder medication), and dialysis (the 4Ds). Adherence to the 4Ds is challenging for patients.
DESIGN
A pragmatic cluster randomized controlled trial with repeated measures.
METHODS
Participants were adults receiving haemodialysis with high serum phosphate (>1.6 mmol/L for at least 3 months) recruited between August 2017 -May 2018. Cluster randomization was according to haemodialysis treatment shifts. The 'teach-back' intervention was designed to improve phosphate control. Expected outcomes were reduced serum phosphate and increased knowledge of phosphate in end-stage kidney disease, self-efficacy and adherence to diet, drugs, and dialysis.
RESULTS
There were no differences between groups at baseline. Both groups had similar mean serum phosphate over time; at three months, 46% of the intervention group achieved reductions that met the target serum phosphate level compared with 33% of the control group. There were significant improvements in knowledge of phosphate in end-stage kidney disease, self-efficacy and adherence to diet, drugs, and dialysis (missing) in the intervention group compared with control group.
CONCLUSION
The 4Ds, a bundled self-management intervention, was effective in improving patient confidence and adherence to phosphate control methods.
IMPACT
The 4Ds intervention bundles together four essential strategies for preventing and controlling hyperphosphataemia in end-stage kidney disease.
TRIAL REGISTRATION
ACTRN12617000703303 Registered 16/05/2017.",2020,"The 4Ds, a bundled self-management intervention, was effective in improving patient confidence and adherence to phosphate control methods.
","['adults with end-stage kidney disease receiving haemodialysis', 'adults receiving haemodialysis', 'Participants were adults receiving haemodialysis with high serum phosphate (>1.6\xa0mmol/L for at least 3\xa0months) recruited between August 2017 -May 2018']","['bundled self-management intervention (taking control of your phosphate with the 4Ds', 'bundled phosphate control intervention (4Ds']","['target serum phosphate level', 'serum phosphate and increased knowledge of phosphate in end-stage kidney disease, self-efficacy and adherence to diet, drugs, and dialysis', 'knowledge of phosphate in end-stage kidney disease, self-efficacy and adherence to diet, drugs, and dialysis (missing']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3834230', 'cui_str': 'Take Control'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]",,0.0439308,"The 4Ds, a bundled self-management intervention, was effective in improving patient confidence and adherence to phosphate control methods.
","[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Milazi', 'Affiliation': 'School of Nursing, Queensland University of Technology (QUT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Clint', 'Initials': 'C', 'LastName': 'Douglas', 'Affiliation': 'School of Nursing, Queensland University of Technology (QUT), Brisbane, Queensland, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Bonner', 'Affiliation': 'Kidney Health Service, Metro North Hospital and Health Service, Brisbane, Queensland, Australia.'}]",Journal of advanced nursing,['10.1111/jan.14700']
2707,33277716,Impact of the United Network for Organ Sharing 2018 Donor Heart Allocation System on Transplant Morbidity and Mortality.,"BACKGROUND
While the revised UNOS HTx donor allocation system aimed to minimize waitlist mortality by prioritizing more critically ill transplant candidates, there is concern for increased post-transplant morbidity and mortality. We examined the impact of the revised allocation system on waitlist and post-transplant outcomes at a high-volume transplant center.
METHODS
169 adult patients underwent first-time single-organ HTx one year before (Era 1: 79 patients) and after (Era 2: 90 patients) implementation of the new allocation system (10/18/2018). Clinical characteristics, waitlist outcomes, and post-transplant morbidity and mortality were compared.
RESULTS
Era 2 patients were twice as likely to be transplanted on temporary mechanical circulatory support (43% v. 19%, p<0.0001). While Era 2 waitlist time was shorter (10 v. 43 days, p<0.001), exception status requests (21.1% v. 17.9%) and waitlist mortality (3.3% v. 2.2%) were similar. There was no difference in primary graft dysfunction, intensive care unit or hospital length of stay, readmissions, rejection, allograft vasculopathy, or 1-year survival (91.1% v. 93.7%).
CONCLUSIONS
In a high-volume center, the revised HTx allocation system shortened waitlist time with no significant change in waitlist mortality or observed impact on post-transplant outcomes. With careful patient selection, the revised allocation system may optimize waitlist and post-transplant outcomes.",2020,"There was no difference in primary graft dysfunction, intensive care unit or hospital length of stay, readmissions, rejection, allograft vasculopathy, or 1-year survival (91.1% v. 93.7%).
",['169 adult patients underwent first-time single-organ HTx one year before (Era 1: 79 patients) and after (Era 2: 90 patients) implementation of the new allocation system (10/18/2018'],[],"['post-transplant morbidity and mortality', 'temporary mechanical circulatory support', 'Transplant Morbidity and Mortality', 'exception status requests', 'primary graft dysfunction, intensive care unit or hospital length of stay, readmissions, rejection, allograft vasculopathy, or 1-year survival', 'waitlist mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0948031', 'cui_str': 'Primary Graft Dysfunction'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0042373', 'cui_str': 'Vascular disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]",169.0,0.0989863,"There was no difference in primary graft dysfunction, intensive care unit or hospital length of stay, readmissions, rejection, allograft vasculopathy, or 1-year survival (91.1% v. 93.7%).
","[{'ForeName': 'Lily K', 'Initials': 'LK', 'LastName': 'Stern', 'Affiliation': 'Department of Cardiology, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Velleca', 'Affiliation': 'Comprehensive Transplant Center, Cedars-Sinai, Los Angeles, California, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Nishihara', 'Affiliation': 'Department of Cardiology, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiology, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zaliznyak', 'Affiliation': 'Department of Cardiology, USA.'}, {'ForeName': 'Jignesh', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Department of Cardiology, USA.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Hamilton', 'Affiliation': 'Department of Cardiology, USA.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Ramzy', 'Affiliation': 'Department of Cardiac Surgery, Smidt Heart Institute, USA.'}, {'ForeName': 'Fardad', 'Initials': 'F', 'LastName': 'Esmailian', 'Affiliation': 'Department of Cardiac Surgery, Smidt Heart Institute, USA.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Kobashigawa', 'Affiliation': 'Department of Cardiology, USA.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Kittleson', 'Affiliation': 'Department of Cardiology, USA.'}]",Clinical transplantation,['10.1111/ctr.14181']
2708,33277370,Vaccine-Induced Intratumoral Lymphoid Aggregates Correlate with Survival Following Treatment with a Neoadjuvant and Adjuvant Vaccine in Patients with Resectable Pancreatic Adenocarcinoma.,"PURPOSE
Immunotherapy is currently ineffective for nearly all pancreatic ductal adenocarcinomas(PDAC), largely due to its tumor microenvironment(TME) that lacks antigen experienced T effector cells(Teffs). Vaccine-based immunotherapies are known to activate antigen-specific Teffs in the peripheral blood. To evaluate the effect of vaccine therapy on the PDAC TME, we designed a neoadjuvant and adjuvant clinical trial of an irradiated, granulocyte-macrophage colony-stimulating factor(GM-CSF)-secreting, allogeneic PDAC vaccine(GVAX).
EXPERIMENTAL DESIGN
Eighty-seven eligible patients with resectable PDAC were randomly assigned(1:1:1) to receive GVAX alone or in combination with two forms of low-dose cyclophosphamide(Cy). Resected tumors following neoadjuvant immunotherapy were assessed for the formation of tertiary lymphoid aggregates(TLA) in response to treatment. The clinical endpoints are disease-free survival(DFS) and overall survival(OS).
RESULTS
The neoadjuvant treatment with GVAX either alone or with two forms of low dose Cy is safe and feasible without adversely increasing the surgical complication rate. Patients in Arm A who received neoadjuvant and adjuvant GVAX alone had a trend toward longer median OS(35.0 months) than that(24.8 months) in the historical controls who received adjuvant GVAX alone. However, Arm C, who received low dose oral Cy in addition to GVAX, had a significantly shorter DFS than Arm A. When comparing patients with OS>24 months to those with OS<15 months, longer OS was found to be associated with higher density of intratumoral TLA.
CONCLUSIONS
It is safe and feasible to use a neoadjuvant immunotherapy approach for PDACs to evaluate early biologic responses. In-depth analysis of TLAs is warranted in future neoadjuvant immunotherapy clinical trials.",2020,Patients in Arm A who received neoadjuvant and adjuvant GVAX alone had a trend toward longer median OS(35.0 months) than that(24.8 months) in the historical controls who received adjuvant GVAX alone.,"['Eighty-seven eligible patients with resectable PDAC', 'Patients with Resectable Pancreatic Adenocarcinoma']","['GVAX alone or in combination with two forms of low-dose cyclophosphamide(Cy', 'Neoadjuvant and Adjuvant Vaccine', 'GVAX', 'irradiated, granulocyte-macrophage colony-stimulating factor(GM-CSF)-secreting, allogeneic PDAC vaccine(GVAX', 'neoadjuvant and adjuvant GVAX', 'vaccine therapy', 'Vaccine-based immunotherapies']","['disease-free survival(DFS) and overall survival(OS', 'surgical complication rate']","[{'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0861748', 'cui_str': 'Pancreatic adenocarcinoma resectable'}]","[{'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1277077', 'cui_str': 'Irradiated blood product'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0042209', 'cui_str': 'Therapy, Vaccine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",87.0,0.044874,Patients in Arm A who received neoadjuvant and adjuvant GVAX alone had a trend toward longer median OS(35.0 months) than that(24.8 months) in the historical controls who received adjuvant GVAX alone.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine lzheng6@jhmi.edu.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Pancreatic Cancer Precision Medicine Program, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Barish H', 'Initials': 'BH', 'LastName': 'Edil', 'Affiliation': 'Surgery, University of Colorado Anschutz Medical Campus.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Judkin', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Dwayne L', 'Initials': 'DL', 'LastName': 'Thomas', 'Affiliation': 'Department of Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bever', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Guanglan', 'Initials': 'G', 'LastName': 'Mo', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Solt', 'Affiliation': 'Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hoare', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Raka', 'Initials': 'R', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Pathology, Johns Hopkins Medicine.'}, {'ForeName': 'Arsen', 'Initials': 'A', 'LastName': 'Osipov', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Beth L', 'Initials': 'BL', 'LastName': 'Onners', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Purtell', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Rose M', 'Initials': 'RM', 'LastName': 'Parkinson', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Hacker-Prietz', 'Affiliation': 'Radiation Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Herman', 'Affiliation': 'Radiation Oncology, Northwell Health.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Nilofer S', 'Initials': 'NS', 'LastName': 'Azad', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'De Jesus-Acosta', 'Affiliation': 'Department of Medical Oncology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Alex B', 'Initials': 'AB', 'LastName': 'Blair', 'Affiliation': 'Department of Surgery, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Soares', 'Affiliation': 'Surgery, Memorial Sloan Kettering Cancer Center.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Manos', 'Affiliation': 'Department of Surgery, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Cameron', 'Affiliation': 'Surgery, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Makary', 'Affiliation': 'Department of Surgery, Johns Hopkins Hospital.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Weiss', 'Affiliation': 'Zucker School of Medicine at Hofstra, Northwell Health System.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Schulick', 'Affiliation': 'Surgery and Cancer Center, University of Colorado, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Surgery, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Wolfgang', 'Affiliation': 'Department of Surgery, Johns Hopkins Medicine.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thompson', 'Affiliation': 'Pathology, JJohns Hopkins University School of Medicine.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Biostatistics, Johns Hopkins Bloomberg School of Public Health.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Oncology, Sidney Kimmel Cancer Center at Johns Hopkins University School of Medicine.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-2974']
2709,33277338,Baseline Assessment of Circulating microRNAs Near Diagnosis of Type 1 Diabetes Predicts Future Stimulated Insulin Secretion.,"Type 1 diabetes is an autoimmune disease resulting in severely impaired insulin secretion. We investigated whether circulating microRNAs (miRNAs) are associated with residual insulin secretion at diagnosis and predict the severity of its future decline. We studied 53 newly diagnosed subjects enrolled in placebo groups of TrialNet clinical trials. We measured serum levels of 2,083 miRNAs using RNAseq technology, in fasting samples from the baseline visit (<100 days from diagnosis), during which residual insulin secretion was measured with a mixed meal tolerance test (MMTT). Area under the curve (AUC) C-peptide and peak C-peptide were stratified by quartiles of expression of 31 miRNAs. After adjustment for baseline C-peptide, age, BMI and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit. Thus, miRNA assessment at baseline identifies associations with C-peptide and stratifies subjects for future severity of C-peptide loss after 1 year. We suggest that miRNAs may be useful in predicting future C-peptide decline for improved subject stratification in clinical trials.",2020,"After adjustment for baseline C-peptide, age, BMI and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit.",['53 newly diagnosed subjects enrolled in placebo groups of TrialNet clinical trials'],[],"['Area under the curve (AUC) C-peptide and peak C-peptide', 'Baseline Assessment of Circulating microRNAs']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}]",53.0,0.190259,"After adjustment for baseline C-peptide, age, BMI and sex, baseline levels of miR-3187-3p, miR-4302, and the miRNA combination of miR-3187-3p/miR-103a-3p predicted differences in MMTT C-peptide AUC/peak levels at the 12-month visit; the combination miR-3187-3p/miR-4723-5p predicted proportions of subjects above/below the 200 pmol/L clinical trial eligibility threshold at the 12-month visit.","[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Snowhite', 'Affiliation': 'Diabetes Research Institute.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Pastori', 'Affiliation': 'Diabetes Research Institute.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Sosenko', 'Affiliation': 'Department of Medicine, Division of Endocrinology and Metabolism.'}, {'ForeName': 'Shari Messinger', 'Initials': 'SM', 'LastName': 'Cayetano', 'Affiliation': 'Department of Public Health Sciences.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pugliese', 'Affiliation': 'Diabetes Research Institute apuglies@med.miami.edu.'}]",Diabetes,['10.2337/db20-0817']
2710,33277302,A Meal Detection Algorithm for the Artificial Pancreas: A Randomized Controlled Clinical Trial in Adolescents With Type 1 Diabetes.,"OBJECTIVE
We developed a meal detection algorithm for the artificial pancreas (AP+MDA) that detects unannounced meals and delivers automatic insulin boluses.
RESEARCH DESIGN AND METHODS
We conducted a randomized crossover trial in 11 adolescents aged 12-18 years with HbA 1c ≥7.5% who missed one or more boluses in the past 6 months. We compared 1 ) continuous subcutaneous insulin infusion (CSII), 2 ) artificial pancreas (AP), and 3 ) AP+MDA. Participants underwent three 9-h interventions involving breakfast with a bolus and lunch without a bolus.
RESULTS
In AP+MDA, the meal detection time was 40.0 (interquartile range 40.0-57.5) min. Compared with CSII, AP+MDA decreased the 4-h postlunch incremental area under the curve (iAUC) from 24.1 ± 9.5 to 15.4 ± 8.0 h ⋅ mmol/L ( P = 0.03). iAUC did not differ between AP+MDA and AP (19.6 ± 10.4 h ⋅ mmol/L, P = 0.21) or between AP and CSII ( P = 0.33). The AP+MDA reduced time >10 mmol/L (58.0 ± 26.6%) compared with CSII (79.6 ± 27.5%, P = 0.02) and AP (74.2 ± 20.6%, P = 0.047).
CONCLUSIONS
The AP+MDA improved glucose control after an unannounced meal.",2020,"OBJECTIVE
We developed a meal detection algorithm for the artificial pancreas (AP+MDA) that detects unannounced meals and delivers automatic insulin boluses.
","['Artificial Pancreas', 'Adolescents With Type 1 Diabetes', '11 adolescents aged 12-18 years with HbA 1c ≥7.5% who missed one or more boluses in the past 6 months']","['9-h interventions involving breakfast with a bolus and lunch without a bolus', 'continuous subcutaneous insulin infusion (CSII), 2 ) artificial pancreas (AP), and 3 ) AP+MDA']","['4-h postlunch incremental area under the curve (iAUC', 'meal detection time', 'iAUC']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",11.0,0.0831234,"OBJECTIVE
We developed a meal detection algorithm for the artificial pancreas (AP+MDA) that detects unannounced meals and delivers automatic insulin boluses.
","[{'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Palisaitis', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'Department of Electrical and Computer Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'von Oettingen', 'Affiliation': ""Department of Pediatrics, Division of Endocrinology, Montreal Children's Hospital, Montreal, Quebec, Canada.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': ""Department of Pediatrics, Division of Endocrinology, Montreal Children's Hospital, Montreal, Quebec, Canada laurent.legault@muhc.mcgill.ca.""}]",Diabetes care,['10.2337/dc20-1232']
2711,33277296,How do programmes to prevent intimate partner violence among the general population impact women with disabilities? Post-hoc analysis of three randomised controlled trials.,"INTRODUCTION
Women with disabilities experience higher rates of intimate partner violence (IPV) than women without disabilities. There remains limited evidence about whether IPV prevention interventions for the general population have benefits for women with disabilities that compare to those for women without disabilities. Using data from IPV prevention randomised controlled trials in diverse locations (Rwanda, South Africa and Afghanistan), we assess whether outcomes differed by disability status.
METHODS
We assessed disability at baseline in three IPV prevention trials. We performed post-hoc analysis of intervention impacts at endline (22 or 24 months post-baseline) stratified by disability status at study baseline and tested an interaction term for disability at baseline by intervention arm for three sets of outcomes: (1) past year experiences of physical, sexual and severe IPV; (2) economic and livelihood outcomes; and (3) health, mental health and substance use outcomes.
RESULTS
At baseline between 17.7% and 26.2% of women reported being disabled. For IPV prevention, in seven out of eight tests across three studies, women with and without disabilities had similar outcomes. For economic, health and substance use outcomes, there was more variation, with women with disabilities reporting both better and worse outcomes than women without disabilities; however there was no clear pattern in these differential results.
CONCLUSION
IPV prevention programmes targeting general populations can prevent IPV among women with disabilities participants with benefits that mirror those for women without disabilities. Benefits for participants with and without disabilities on secondary programme outcomes related to economic empowerment and health may be more varied and should be explicitly monitored.",2020,There remains limited evidence about whether IPV prevention interventions for the general population have benefits for women with disabilities that compare to those for women without disabilities.,"['Women with disabilities experience higher rates of intimate partner violence (IPV) than women without disabilities', 'diverse locations (Rwanda, South Africa and Afghanistan', 'participants with and without disabilities', 'women with disabilities participants', 'women with disabilities']","['IPV prevention interventions', 'IPV prevention programmes']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035978', 'cui_str': 'Rwanda'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001732', 'cui_str': 'Afghanistan'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.309134,There remains limited evidence about whether IPV prevention interventions for the general population have benefits for women with disabilities that compare to those for women without disabilities.,"[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Dunkle', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Tygerberg, South Africa kdunkle@mrc.ac.za.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Esnat', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Stern', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Van Der Heijden', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Tygerberg, South Africa.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Washington', 'Affiliation': 'Project Empower, Durban, South Africa.'}]",BMJ global health,['10.1136/bmjgh-2019-002216']
2712,33277289,"Impact of a compression garment, on top of the usual care, in patients with breast cancer with early disturbance of the lymphatic transport: protocol of a randomised controlled trial.","INTRODUCTION
Breast cancer-related lymphoedema (BCRL) is a common phenomenon. When lymphoedema is diagnosed late, options for treatment are diminished. Therefore, early diagnosis and treatment are very important to alter the potential deleterious evolution. Lymphofluoroscopy visualises the superficial lymphatic architecture in detail, giving the opportunity to detect a disturbance in the lymphatic transport (ie, dermal backflow) before the lymphoedema is clinically visible.The main objective is to investigate if there is an additional effect of a compression garment on top of the usual care (ie, information and exercises) in patients with early disturbance of the lymphatic transport after breast cancer treatment. Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.
METHODOLOGY
All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven are being considered. Patients are assessed before surgery and at 1, 3, 6, 9, 12, 18, 24 and 36 months postoperatively. At each visit, a clinical assessment is performed determining the volume difference between both arms and hands (through circumference measurements and water displacement), the water content, the extracellular fluid, the pitting status and the skinfold thickness. Quality of life questionnaires are filled in. At each visit, a lymphofluoroscopy is performed as well. When a disturbance of the lymphatic transport is seen on lymphofluoroscopy, without the presence of clinical lymphoedema, the patient is randomised in either a control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove).
ETHICS AND DISSEMINATION
The trial is conducted in compliance with the principles of the Declaration of Helsinki (2008), the principles of Good Clinical Practice and in accordance with all applicable regulatory requirements. This protocol has been approved by the Ethical Committee of the University Hospitals Leuven. Results will be disseminated by peer-reviewed scientific journals and presentation at international congresses.
TRIAL REGISTRATION NUMBER
NCT03210311 CONCLUSION: The investigators hypothesise that development of clinical BCRL can be prevented and/or the dermal backflow can be stabilised or improved, if a preventive treatment with compression garment is started in the early phase of disturbance.",2020,"Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.
","['patients with early disturbance of the lymphatic transport after breast cancer treatment', 'All patients scheduled for breast cancer surgery with unilateral axillary lymph node dissection or sentinel node biopsy in the Multidisciplinary Breast Clinic of the University Hospitals Leuven', 'patients with breast cancer with early disturbance of the lymphatic transport']","['control group receiving usual care or a preventive treatment group receiving usual care and a compression garment (whether or not combined with a glove', 'compression garment']",['Quality of life questionnaires'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C3810844', 'cui_str': 'Breast clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0206069', 'cui_str': 'Glove'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0395955,"Development of clinical lymphoedema and/or deterioration of the dermal backflow visualised by lymphofluoroscopy is investigated.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Thomis', 'Affiliation': 'Department of Vascular Surgery, University Hospitals Leuven, Leuven, Belgium sarah.thomis@uzleuven.be.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Devoogdt', 'Affiliation': 'Department of Vascular Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Bechter-Hugl', 'Affiliation': 'Department of Vascular Surgery, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Nevelsteen', 'Affiliation': 'Multidisciplinary Breast Centre, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Multidisciplinary Breast Centre, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Fourneau', 'Affiliation': 'Department of Vascular Surgery, University Hospitals Leuven, Leuven, Belgium.'}]",BMJ open,['10.1136/bmjopen-2020-042018']
2713,33277288,External barriers for including parents of preterm infants in a randomised clinical trial in the neonatal intensive care unit in Sweden: a descriptive study.,"OBJECTIVES
Performing randomised controlled trials (RCTs) in neonatal intensive care is challenging in many ways. While restrictive inclusion criteria or busy study protocols are obvious barriers, external barriers leading to termination of a study are seldom discussed. The aim of this study was to describe barriers for inclusion of families in neonatal intensive care in an RCT aiming to evaluate the effects of continuous skin-to-skin contact on mood and sleep quality in parents of preterm infants, as well as the quality of parent-infant interaction and salivary cortisol concentrations at the time of discharge.
DESIGN
A descriptive study.
SETTING
Three out of seven tertiary neonatal intensive care units in Sweden participated in a two-arm RCT that was terminated because of low inclusion rate.
PARTICIPANTS
Before termination of the study, 11 out of 242 families assessed for eligibility were included for participation.
RESULTS
The major barriers for inclusion in this RCT were external due to (1) lack of intensive care beds in the neonatal ward, causing medically stable infants to be transferred back to the referring hospital quicker than expected, (2) moving directly from the delivery room to a family room without passing an open bay intensive care room or (3) transferring from one neonatal ward to another with the same care level to increase availability of intensive care beds where needed. Other barriers were the inclusion criteria 'single-birth' and 'Swedish-speaking parent'.
CONCLUSIONS
The major barriers for including participants were external constituted by transferals between neonatal wards and cities due to lack of intensive care beds. This is a multifactorial issue related to organisational structures. However, since this affects the possibilities to perform research this study highlights some suggestions to consider when planning prospective intervention studies within a neonatal setting.
TRIAL REGISTRATION NUMBER
NCT03004677.",2020,"PARTICIPANTS
Before termination of the study, 11 out of 242 families assessed for eligibility were included for participation.
","['Before termination of the study, 11 out of 242 families assessed for eligibility were included for participation', 'Three out of seven tertiary neonatal intensive care units in Sweden participated in a two-arm RCT that was terminated because of low inclusion rate', 'neonatal intensive care unit in Sweden', 'parents of preterm infants']",['continuous skin-to-skin contact'],"['mood and sleep quality', 'quality of parent-infant interaction and salivary cortisol concentrations']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",242.0,0.106372,"PARTICIPANTS
Before termination of the study, 11 out of 242 families assessed for eligibility were included for participation.
","[{'ForeName': 'Evalotte', 'Initials': 'E', 'LastName': 'Mörelius', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden evalotte.morelius@liu.se.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Olsson', 'Affiliation': 'School of Health Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sahlén Helmer', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Thernström Blomqvist', 'Affiliation': ""Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Angelhoff', 'Affiliation': ""Crown Princess Victoria's Child and Youth Hospital and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.""}]",BMJ open,['10.1136/bmjopen-2020-040991']
2714,33277285,Randomised controlled trial of conditioning regimen for cord blood transplantation for adult myeloid malignancies comparing high-dose cytarabine/cyclophosphamide/total body irradiation with versus without G-CSF priming: G-CONCORD study protocol.,"INTRODUCTION
A better long-term quality of life after umbilical cord blood transplantation (CBT) is observed compared with transplants from other alternative donors, whereas graft failure and relapses after CBT are still major issues. To minimise graft failure and relapse after CBT, intensification of conditioning by the addition of high-dose cytosine arabinoside (CA) and concomitant continuous use of granulocyte-colony stimulating factor (G-CSF) are reported to convey a significantly better survival after CBT in some retrospective studies. To confirm the effect of G-CSF plus CA combination, in addition to the standard conditioning regimen, cyclophosphamide (CY)/total body irradiation (TBI), we design a randomised controlled study comparing CA/CY/TBI with versus without G-CSF priming (G-CSF combined conditioned cord blood transplantation [G-CONCORD] study).
METHODS AND ANALYSIS
This is a multicentre, open-label, randomised phase III study that aimed to compare G-CSF+CA/CY/TBI as a conditioning regimen for CBT with CA/CY/TBI. Patients with acute myeloid leukaemia or myelodysplastic syndrome, aged 16-55 years, are eligible. The target sample size is 160 and the registration period is 4 years. The primary endpoint is the 2-year disease-free survival rate after CBT. The secondary endpoints are overall survival, relapse, non-relapse mortality, acute and chronic graft-versus-host disease, engraftment rate, time to neutrophil recovery, short-term adverse events, incidence of infections and causes of death.This study employs a single one-to-one web-based randomisation between the with-G-CSF versus without-G-CSF groups after patient registration. Combination of high-dose CA and CY/TBI in both groups is used for conditioning.
ETHICS AND DISSEMINATION
The study protocol was approved by the central review board, Nagoya University Certified Review Board, after the enforcement of the Clinical Trials Act in Japan. The manuscripts presenting data from this study will be submitted for publication in quality peer-reviewed medical journals. Study findings will be disseminated via presentations at national/international conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBERS
UMIN000029947 and jRCTs041180059.",2020,"A better long-term quality of life after umbilical cord blood transplantation (CBT) is observed compared with transplants from other alternative donors, whereas graft failure and relapses after CBT are still major issues.","['adult myeloid malignancies comparing high-dose', 'Patients with acute myeloid leukaemia or myelodysplastic syndrome, aged 16-55 years, are eligible']","['G-CSF+CA/CY/TBI', 'cytosine arabinoside (CA', 'granulocyte-colony stimulating factor (G-CSF', 'cyclophosphamide (CY)/total body irradiation (TBI', 'cytarabine/cyclophosphamide/total body irradiation with versus without G-CSF', 'G-CSF plus CA combination', 'umbilical cord blood transplantation (CBT', 'CA/CY/TBI with versus without G-CSF priming (G-CSF combined conditioned cord blood transplantation [G-CONCORD', 'G-CSF versus without-G-CSF']","['graft failure and relapses', '2-year disease-free survival rate', 'overall survival, relapse, non-relapse mortality, acute and chronic graft-versus-host disease, engraftment rate, time to neutrophil recovery, short-term adverse events, incidence of infections and causes of death']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2939461', 'cui_str': 'Myeloid neoplasm'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4510188', 'cui_str': 'Neutrophil recovery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}]",,0.144779,"A better long-term quality of life after umbilical cord blood transplantation (CBT) is observed compared with transplants from other alternative donors, whereas graft failure and relapses after CBT are still major issues.","[{'ForeName': 'Seitaro', 'Initials': 'S', 'LastName': 'Terakura', 'Affiliation': 'Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan tseit@med.nagoya-u.ac.jp.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Konuma', 'Affiliation': 'Department of Hematology/Oncology, The Institute of Medical Science The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Hematology, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Yukiyasu', 'Initials': 'Y', 'LastName': 'Ozawa', 'Affiliation': 'Department of Hematology and Oncology, Japanese Red Cross Nagoya First Hospital, Nagoya, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Onizuka', 'Affiliation': 'Department of Hematology and Oncology, Tokai University School of Medicine Graduate School of Medicine, Isehara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nanno', 'Affiliation': 'Department of Hematology, Osaka City University Graduate School of Medicine School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Onishi', 'Affiliation': 'Department of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Aotsuka', 'Affiliation': 'Division of Hematology-Oncology, Japanese Red Cross Society Narita Hospital, Narita, Japan.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Kondo', 'Affiliation': 'Department of Hematology and Oncology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Kawakita', 'Affiliation': 'Department of Hematology, National Hospital Organisation Kumamoto Medical Center, Kumamoto, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Kato', 'Affiliation': 'Division of Hematology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Division of Hematology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Biostatistics, Graduate School of Medicine, Tohoku University, Sendai, Japan.'}, {'ForeName': 'Yachiyo', 'Initials': 'Y', 'LastName': 'Kuwatsuka', 'Affiliation': 'Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Hematology/Oncology, The Institute of Medical Science The University of Tokyo, Tokyo, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-040467']
2715,33277284,Study protocol: treatment with caffeine of the very preterm infant in the delivery room: a feasibility study.,"INTRODUCTION
Early treatment with caffeine in the delivery room has been proposed to decrease the need for mechanical ventilation (MV) by limiting episodes of apnoea and improving respiratory mechanics in preterm infants. Thus, the purpose of this feasibility study is to verify the hypothesis that intravenous or enteral administration of caffeine can be performed in the preterm infant in the delivery room.
METHODS AND ANALYSIS
In this multicentre prospective study, infants with 25 +0 -29 +6 weeks of gestational age will be enrolled and randomised to receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth. Caffeine plasma level will be measured at 60±15 min after administration and 60±15 min before the next dose (5 mg/kg). The primary endpoint will be evaluation of the success rate of intravenous and enteral administration of caffeine in the delivery room. Secondary endpoints will be the comparison of success rate of intravenous versus oral administration and the evaluation of the need for MV in treated infants. In the absence of previous references, we arbitrarily decided to study 20 infants treated with intravenous caffeine and 20 infants treated with enteral caffeine. Primary endpoint will be evaluated measuring the success rate of intravenous and enteral caffeine administration which will be considered a success when it is followed by the achievement of the caffeine therapeutic level (8-25 µg/mL) 60±15 min before administration of the second dose.
ETHICS AND DISSEMINATION
The study has been approved by the Italian Medicines Agency (AIFA: AIFA/RSC/P/32755) and by Comitato Etico Pediatrico Regione Toscana. The results will be published in peer-reviewed academic journals.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov identifier NCT04044976; EudraCT number 2018-003626-91.",2020,Secondary endpoints will be the comparison of success rate of intravenous versus oral administration and the evaluation of the need for MV in treated infants.,"['20 infants treated with', 'infants with 25 +0 -29 +6 weeks of gestational age', 'preterm infants']","['caffeine', 'caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube', 'enteral caffeine', 'intravenous caffeine']","['success rate of intravenous and enteral administration of caffeine in the delivery room', 'Caffeine plasma level', 'success rate of intravenous versus oral administration and the evaluation of the need for MV']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0054436', 'cui_str': 'Caffeine citrate'}, {'cui': 'C0041637', 'cui_str': 'Structure of umbilical vein'}, {'cui': 'C0450104', 'cui_str': 'Orogastric'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0011212', 'cui_str': 'Delivery suite'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",,0.0893573,Secondary endpoints will be the comparison of success rate of intravenous versus oral administration and the evaluation of the need for MV in treated infants.,"[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Department of Neurosciences, Psychology, Drug Research and Child Health, University of Florence, Firenze, Italy cdani@unifi.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Cecchi', 'Affiliation': 'Division of Neonatology, Careggi University Hospital of Florence, Florence, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Remaschi', 'Affiliation': 'Division of Neonatology, Careggi University Hospital of Florence, Florence, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Mercadante', 'Affiliation': 'Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico of Milan, University of Milan, Florence, Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'la Marca', 'Affiliation': 'Laboratory of Clinical Chemistry and Pharmacology of the A Meyer Pediatric Hospital of Florence, University of Florence, Florence, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Boni', 'Affiliation': 'Department of Human Pathology and Oncology, University of Florence, Florence, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': 'Department of Clinical Sciences and Community Health, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan, Italy.'}]",BMJ open,['10.1136/bmjopen-2020-040105']
2716,33277281,Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial.,"INTRODUCTION
Optimal glycaemic control is beneficial to prevent and delay microvascular complications in patients with type 1 diabetes mellitus (T1DM). The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited. This study aims to evaluate the effect of FGM in suboptimally controlled adult patients with T1DM .
METHODS AND ANALYSIS
This open-label, multicentre, randomised trial will be conducted at eight tertiary hospitals and recruit 104 adult participants (≥18 years old) with T1DM diagnosed for at least 1 year and with suboptimal glycaemic control (glycated haemoglobin (HbA1c) ranging from 7.0% to 10.0%). After a run-in period (baseline, 0-2 weeks), eligible participants will be randomised 1:1 to either use FGM or self-monitoring of blood glucose alone consequently for the next 24 weeks. At baseline, 12-14 weeks and 24-26 weeks, retrospective continuous glucose monitoring (CGM) systems will be used in both groups for device-related data collection. Biological metrics, including HbA1c, blood routine, lipid profiles, liver enzymes, questionnaires and adverse events, will be assessed at baseline, week 14 and week 26. All analyses will be conducted on the intent-to-treat population. Efficacy endpoint analyses will also be repeated on the per-protocol population. The primary outcome is the change of HbA1c from baseline to week 26. The secondary outcomes are the changes of CGM metrics, including time spent in range, time spent in target, time spent below range, time spent above range, SD, coefficient of variation, mean amplitude of glucose excursions, high or low blood glucose index, mean of daily differences, percentage of HbA1c in target (<7%), frequency of FGM use, total daily insulin dose and the scores of questionnaires including Diabetes Distress Scale, Hypoglycemia Fear Scale and European Quality of Life Scale.
ETHICS AND DISSEMINATION
This study was approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University in January 2017. Ethical approval has been obtained at all centres. All participants will be provided with oral and written information about the trial. The study will be disseminated by peer-review publications and conference presentations.
TRIAL REGISTRATION NUMBER
NCT03522870.",2020,"The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited.","['suboptimally controlled adult patients with T1DM ', 'eight tertiary hospitals and recruit 104 adult participants (≥18 years old) with T1DM diagnosed for at least 1\u2009year and with suboptimal glycaemic control (glycated haemoglobin (HbA1c) ranging from 7.0% to 10.0', 'adult patients with type 1 diabetes mellitus', 'Third Affiliated Hospital of Sun Yat-sen University in January 2017', 'patients with type 1 diabetes mellitus (T1DM']","['flash glucose monitoring (FGM', 'novel flash glucose monitoring system', 'FGM', 'FGM or self-monitoring of blood glucose alone']","['Biological metrics, including HbA1c, blood routine, lipid profiles, liver enzymes, questionnaires and adverse events', 'changes of CGM metrics, including time spent in range, time spent in target, time spent below range, time spent above range, SD, coefficient of variation, mean amplitude of glucose excursions, high or low blood glucose index, mean of daily differences, percentage of HbA1c in target (<7%), frequency of FGM use, total daily insulin dose and the scores of questionnaires including Diabetes Distress Scale, Hypoglycemia Fear Scale and European Quality of Life Scale', 'change of HbA1c', 'glycaemic control']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}]","[{'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}]","[{'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0085635', 'cui_str': 'Photopsia'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",104.0,0.339504,"The benefits of flash glucose monitoring (FGM) have been proved among well-controlled adults with T1DM, but evidence for FGM in adults with T1DM who have suboptimal glycaemic control is limited.","[{'ForeName': 'Yongwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Hongrong', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Department of Endocrinology and Metabolism, Third Affiliated Hospital of Sun Yat-sen University;Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology and Metabolism, Third Affiliated Hospital of Sun Yat-sen University;Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Daizhi', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology and Metabolism, Third Affiliated Hospital of Sun Yat-sen University;Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology and Metabolism, Third Affiliated Hospital of Sun Yat-sen University;Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yao', 'Affiliation': 'Department of Endocrinology and Metabolism, Third Affiliated Hospital of Sun Yat-sen University;Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Endocrinology and Metabolism, Third Affiliated Hospital of Sun Yat-sen University;Guangdong Provincial Key Laboratory of Diabetology, Guangzhou, China yanjh79@163.com wengjp@ustc.edu.cn.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Weng', 'Affiliation': 'Department of Endocrinology, the First Affiliated Hospital of USTC, Division of Life Science and Medicine, University of Science and Technology of China, Hefei, China yanjh79@163.com wengjp@ustc.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2020-039400']
2717,33277277,"Effect of Housing First on violence-related traumatic brain injury in adults with experiences of homelessness and mental illness: findings from the At Home/Chez Soi randomised trial, Toronto site.","OBJECTIVES
People experiencing homelessness have a high prevalence and incidence of traumatic brain injury (TBI) due to violence. Little is known about the effectiveness of interventions to reduce TBI in this population. This study assessed the effect of Housing First (HF) on violence-related TBI in adults with experiences of homelessness and mental illness.
DESIGN
Pragmatic randomised trial.
PARTICIPANTS
381 participants in the Toronto site of the At Home/Chez randomised trial.
INTERVENTION
HF participants were provided with scattered-site housing using rent supplements and supports from assertive community treatment or intensive case management teams (n=218, 57.2%). Control participants had access to treatment as usual (TAU) in the community (n=163, 42.8%).
MAIN OUTCOME MEASURES
Primary outcomes were an incident physical violence-related TBI event and the number of physical violence-related TBI events during the follow-up period (January 2014 to March 2017). Interval-censored survival time regression and zero-inflated negative binomial regression were used to assess the effect of HF on primary outcomes.
RESULTS
Among study participants, 9.2% (n=35) had an incident physical violence-related TBI event, and the mean physical violence-related TBI events was 0.16 (SD ±0.6). Compared with TAU participants, HF participants did not have a significantly lower risk of an incident violence-related TBI event (adjusted HR : 0.58 (95% CI, 0.29 to 1.14)), but they had a significantly lower number of physical violence-related TBI events (unadjusted incidence rate ratio (IRR): 0.22 (95% CI, 0.06 to 0.78); adjusted IRR: 0.15 (95% CI, 0.05 to 0.48)).
CONCLUSION
HF may be a useful intervention to reduce the burden of TBI due to physical violence among homeless individuals with mental illness.
TRIAL REGISTRATION NUMBER
ISRCTN42520374.",2020,"HF may be a useful intervention to reduce the burden of TBI due to physical violence among homeless individuals with mental illness.
","['adults with experiences of homelessness and mental illness', '381 participants in the Toronto site of the At Home/Chez randomised trial', 'homeless individuals with mental illness']","['scattered-site housing using rent supplements and supports from assertive community treatment or intensive case management teams', 'Housing First', 'Housing First (HF']","['physical violence-related TBI events', 'incident violence-related TBI event', 'incident physical violence-related TBI event, and the mean physical violence-related TBI events', 'incident physical violence-related TBI event and the number of physical violence-related TBI events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C4708787', 'cui_str': '381'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}]","[{'cui': 'C0439742', 'cui_str': 'Scattered'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2713614', 'cui_str': 'Assertive Community Treatment'}, {'cui': 'C0085971', 'cui_str': 'Case management'}]","[{'cui': 'C0476480', 'cui_str': 'Physical violence'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.334362,"HF may be a useful intervention to reduce the burden of TBI due to physical violence among homeless individuals with mental illness.
","[{'ForeName': 'Cilia', 'Initials': 'C', 'LastName': 'Mejia-Lancheros', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada Cilia.Mejia-Lancheros@unityhealth.to.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lachaud', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Stergiopoulos', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Flora I', 'Initials': 'FI', 'LastName': 'Matheson', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Rosane', 'Initials': 'R', 'LastName': 'Nisenbaum', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': ""O'Campo"", 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Hwang', 'Affiliation': ""MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2020-038443']
2718,33277059,"Safety of the adjuvanted recombinant zoster vaccine in adults aged 50 years or older. A phase IIIB, non-randomized, multinational, open-label study in previous ZOE-50 and ZOE-70 placebo recipients.","BACKGROUND
Efficacy of the adjuvanted recombinant zoster vaccine (RZV) against herpes zoster (HZ) was demonstrated in pivotal trials ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229). This study was designed to offer RZV to placebo recipients of these parent studies.
METHODS
Vaccine safety and suspected HZ episode occurrence were assessed for 12 months following vaccination.
RESULTS
Of the 14,550 eligible participants, 8687 received RZV and 97.8% completed the 2-dose schedule. During the 30-day post-vaccination period, 5175 (59.6%) participants experienced ≥ 1 unsolicited adverse event (AE), 4422 (50.9%) were vaccination-related. The most common AEs were injection-site reactions, pyrexia, and headache. During the study, 734 (8.4%) participants reported ≥ 1 serious AE (SAE) and 62 (0.7%) reported ≥ 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related. Suspected HZ episodes were reported by 30 participants (0.3%).
CONCLUSIONS
Nature and incidence of AEs, SAEs, and pIMDs were as expected and in line with the parent studies.",2020,"During the study, 734 (8.4%) participants reported ≥ 1 serious AE (SAE) and 62 (0.7%) reported ≥ 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related.","['14,550 eligible participants', 'adults aged 50\xa0years or older']","['placebo', 'adjuvanted recombinant zoster vaccine (RZV', 'ZOE-50', 'adjuvanted recombinant zoster vaccine']","['≥\xa01 serious AE (SAE', 'injection-site reactions, pyrexia, and headache', 'Suspected HZ episodes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C4530095', 'cui_str': 'Varicella zoster virus glycoprotein E, recombinant'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",14550.0,0.378908,"During the study, 734 (8.4%) participants reported ≥ 1 serious AE (SAE) and 62 (0.7%) reported ≥ 1 potential immune-mediated disease (pIMD); 2 of each were assessed as vaccination-related.","[{'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Ocran-Appiah', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Boutry', 'Affiliation': 'Aixial an Alten Company, Chaussée de Charleroi 112, 1060 Brussels, Belgium C/O GSK, Wavre, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'GSK, Avenue Fleming 20, 1300 Wavre, Belgium.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Soni', 'Affiliation': 'GSK, Level 4, Prestige Trade Tower, 46, Palace Road, Sampangi Rama Nagar, Bengaluru, Karnataka 560001, India.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Schuind', 'Affiliation': 'GSK, 14200 Shady Grove Road, Rockville, MD 20850, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2020.10.029']
2719,33277060,Re: Hormonal treatment isolated versus hormonal treatment associated with electrotherapy for pelvic pain control in deep endometriosis: Randomized clinical trial.,,2020,,['deep endometriosis'],['electrotherapy'],[],"[{'cui': 'C4510788', 'cui_str': 'Deep endometriosis'}]","[{'cui': 'C0013787', 'cui_str': 'Electrotherapy'}]",[],,0.0319589,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hirsch', 'Affiliation': ""Institute for Women's Health, University College London, London, United Kingdom. Electronic address: m.hirsch@nhs.uk.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Institute for Women's Health, University College London, London, United Kingdom.""}, {'ForeName': 'James M N', 'Initials': 'JMN', 'LastName': 'Duffy', 'Affiliation': ""Institute for Women's Health, University College London, London, United Kingdom; King's Fertility, The Fetal Medicine Research Institute, London, United Kingdom.""}, {'ForeName': 'Cindy M', 'Initials': 'CM', 'LastName': 'Farquhar', 'Affiliation': 'Cochrane Gynaecology and Fertility Group, Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.11.051']
2720,33276978,[Response to: Preemptive nebulized ketamine for pain control after tonsillectomy in children: randomized controlled trial].,,2020,,['pain control after tonsillectomy in children'],['Preemptive nebulized ketamine'],[],"[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}]",[],,0.207877,,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Medina', 'Affiliation': 'Universidade Federal de São Paulo, Departamento de Psicobiologia, São Paulo, SP, Brasil.'}, {'ForeName': 'Vinícius', 'Initials': 'V', 'LastName': 'Dokkedal-Silva', 'Affiliation': 'Universidade Federal de São Paulo, Departamento de Psicobiologia, São Paulo, SP, Brasil.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Tufik', 'Affiliation': 'Universidade Federal de São Paulo, Departamento de Psicobiologia, São Paulo, SP, Brasil.'}, {'ForeName': 'Monica Levy', 'Initials': 'ML', 'LastName': 'Andersen', 'Affiliation': 'Universidade Federal de São Paulo, Departamento de Psicobiologia, São Paulo, SP, Brasil. Electronic address: ml.andersen12@gmail.com.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.10.006']
2721,33276959,A Multicentre Randomized Controlled Trial Comparing Plating with Intramedullary Nailing for Extra-articular Distal Tibial Fractures.,"BACKGROUND
The aim of this randomized control trial is to examine the clinical outcomes for distal tibial fractures managed with IMN compared to those managed with plate fixation, to further elucidate the most optimum management.
METHOD
This was a multicentre randomized controlled trial recruited patients 18 years and older sustaining a closed, isolated extra-articular distal tibial fracture from 16/10/2015 to 20/03/2019. Open fractures, polytrauma or too distal fracture to achieve fixation of four cortices with distal interlocking screws for intra-medullary nailing were excluded. The primary outcome was the disability rating index (DRI) assessed at 12 months, whereas secondary outcomes were the SF-12 health questionnaire and Olerud-Molander Ankle Score (OMAS). The data were collected at 3 months, 6 months, 9 months, and 12 months, respectively. An independent t-test was performed for continuous data, whereas, for the analysis of categorical data, a Fisher exact test or a chi-square test was performed. The power of the study was kept at 90% with a p-value of less than 0.05 marked as significant.
RESULTS
There were no significant differences in DRI score between the two managements at 12 months (P>0.05). Although there was a statistically significant difference in DRI score at 6 months in favour of plate fixation (P<0.05) this was not reflected in the DRI scores at 3, 9 and 12 months (P>0.05). Those managed with IMN reported a significantly higher SF-12 score than those managed with plate fixation at 12 months (P<0.05) that was not previously significantly different at 3, 6 or 12 months (P>0.05). Furthermore, those managed with IMN experienced a significantly higher incidence of delayed union and malunion in comparison to those managed with plate fixation (P<0.05). In contrast, those managed with plate fixation experienced a higher incidence of deep infection, requiring debridement.
CONCLUSION
There is no significant difference in disability between the two managements at 12 months. Patients managed with IMN reported a significantly better overall health at 12 months via the SF-12 questionnaire.",2020,There were no significant differences in DRI score between the two managements at 12 months (P>0.05).,"['patients 18 years and older sustaining a closed, isolated extra-articular distal tibial fracture from 16/10/2015 to 20/03/2019', 'Extra-articular Distal Tibial Fractures']","['distal interlocking screws', 'IMN', 'Plating with Intramedullary Nailing']","['DRI scores', 'SF-12 health questionnaire and Olerud-Molander Ankle Score (OMAS', 'SF-12 score', 'disability', 'disability rating index (DRI', 'overall health', 'DRI score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0022132', 'cui_str': 'Isle of Man'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0727488,There were no significant differences in DRI score between the two managements at 12 months (P>0.05).,"[{'ForeName': 'Mr Muhammad', 'Initials': 'MM', 'LastName': 'Tahir', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan. Electronic address: doctor.muhammad.tahir@gmail.com.'}, {'ForeName': 'Dr Noman', 'Initials': 'DN', 'LastName': 'Khan', 'Affiliation': 'Department of Orthopaedics, Ghurki Trust and Teaching Hospital, Lahore, Pakistan.'}, {'ForeName': 'Mr Ejaz Ali', 'Initials': 'MEA', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Orthopaedics, Ghurki Trust and Teaching Hospital, Lahore, Pakistan.'}, {'ForeName': 'Dr Faridullah', 'Initials': 'DF', 'LastName': 'Khan Zimri', 'Affiliation': 'Department of Orthopaedics, National Institute of Rehabilitation Medicine, Islamabad, Pakistan.'}, {'ForeName': 'Dr Nadeem', 'Initials': 'DN', 'LastName': 'Ahmed', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Dr Katherine Rose', 'Initials': 'DKR', 'LastName': 'Watson', 'Affiliation': 'Department of Orthopaedics, Leeds Teaching Hospital Trust, United Kingdom.'}, {'ForeName': 'Dr Allah Rakhio', 'Initials': 'DAR', 'LastName': 'Jamali', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Mr Ahmad', 'Initials': 'MA', 'LastName': 'Faraz', 'Affiliation': 'Department of Orthopaedics, Sir Syed Medical College for Girls and Trust Hospital, Karachi, Pakistan.'}, {'ForeName': 'Prof Amer', 'Initials': 'PA', 'LastName': 'Aziz', 'Affiliation': 'Department of Orthopaedics, Ghurki Trust and Teaching Hospital, Lahore, Pakistan.'}, {'ForeName': 'Prof Ghulam', 'Initials': 'PG', 'LastName': 'Mehboob', 'Affiliation': 'Department of Orthopaedics, Sir Syed Medical College for Girls and Trust Hospital, Karachi, Pakistan.'}]",Injury,['10.1016/j.injury.2020.11.046']
2722,33276817,Postoperative analgesic effect of acupotomy combined with patient-controlled analgesia in patients undergoing video-assisted thoracoscopic surgery: a study protocol for a randomized controlled trial.,"BACKGROUND
Postoperative acute pain is a common issue following thoracic surgery. Acupotomy is a common and safe intervention method for pain treatment in clinical practice. In previous preliminary experiments, we found that acupotomy has a good clinical effect and good safety in the treatment of pain after thoracoscopic surgery. However, due to a lack of a rigorous design and an adequate sample size, its efficacy still requires further confirmation. The purpose of this study will be to explore the efficacy and safety of acupotomy combined with patient-controlled analgesia (PCA) for the treatment of pain after video-assisted thoracic surgery (VATS).
METHODS
The study will be a single-centre, parallel group, randomized controlled trial. Seventy patients with significant pain after thoracoscopic surgery with a visual analogue scale (VAS) score ≥ 7 will be included and randomly distributed into two groups: G1, the acupotomy combined with PCA group; and G2, the conventional PCA group. The primary outcome measure is pain scores at rest and coughing evaluated with the VAS by a blinded observer in the postanaesthesia care unit (PACU) and postoperatively at 1, 2, 4, 8, 12, 24, 48, and 72 h. The secondary outcome measures are postoperative requirements for rescue analgesia, the cumulative amount of self-administered analgesics, the level of sedation (LOS), the Bruggemann comfort scale (BCS), and the functional activity score (FAS) concerning adverse effects and patient satisfaction.
DISCUSSION
This trial has the potential to identify an innovative and effective analgesic method for postoperative pain management for VATS. The findings may advocate for the inclusion of the treatment of comorbid pain after thoracoscopy in current pain management practice guidelines.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1900027191 . Registered on 4 November 2019.",2020,"In previous preliminary experiments, we found that acupotomy has a good clinical effect and good safety in the treatment of pain after thoracoscopic surgery.","['Seventy patients with significant pain after thoracoscopic surgery with a visual analogue scale (VAS) score\u2009≥\u20097 will be included', 'patients undergoing video-assisted thoracoscopic surgery', 'pain after video-assisted thoracic surgery (VATS']","['acupotomy combined with patient-controlled analgesia (PCA', 'acupotomy combined with patient-controlled analgesia', 'acupotomy combined with PCA']","['pain scores at rest and coughing evaluated with the VAS by a blinded observer in the postanaesthesia care unit (PACU', 'Postoperative analgesic effect', 'efficacy and safety', 'postoperative requirements for rescue analgesia, the cumulative amount of self-administered analgesics, the level of sedation (LOS), the Bruggemann comfort scale (BCS), and the functional activity score (FAS) concerning adverse effects and patient satisfaction']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0751551', 'cui_str': 'Thoracoscopic Surgical Procedures'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C4505457', 'cui_str': 'Acupotomy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",70.0,0.250067,"In previous preliminary experiments, we found that acupotomy has a good clinical effect and good safety in the treatment of pain after thoracoscopic surgery.","[{'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Yinyan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Outpatient Department of Guoyitang affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Miaomiao', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, Fujian, China. doctor_lzh71@163.com.'}]",Trials,['10.1186/s13063-020-04926-7']
2723,33276764,Modeling the effect of static stretching and strengthening exercise in lengthened position on balance in low back pain subject with shortened hamstring: a randomized controlled clinical trial.,"BACKGROUND
Hamstring shortening may have negative impacts on function and biomechanics of knee and hip joints and lumbo-pelvic rhythm. Many interventions are believed to correct hamstring to its normal length. There are several reports of impairment in postural control of patients with low back pain. The purpose of this study was to compare the effect of stretching exercise and strengthening exercise in lengthened position of the hamstring muscle on improving the dynamic balance of the person in patients with chronic low back pain with short hamstring muscles.
METHODS
Forty-five patients with hamstring shortening who referred to physiotherapy clinic of Kermanshah university of Medical Sciences, Kermanshah, Iran were randomly allocated to the three groups; static stretching (n = 15), strengthening exercise in lengthened hamstring position (n = 15) and control (n = 15). All groups received conventional physiotherapy for low back pain and the two intervention groups received stretching exercise and strengthening exercise in lengthened position programs as well. All groups performed three treatment sessions for a week, a total of 12 sessions. For balance assessment, Y-Balance test was performed for each participant in three reach directions. To determine the important and significant variables, all variables entered a model (Generalized Estimation Equations method).
RESULTS
The results indicate that based on GEE model, by controlling other variables, participants of static stretching exercise showed more improvement in balance than control group (β = 9.58, p-value = 0.014). Also, balance status showed significant improvement in the end of study compared to baseline of the study (β = 7.71, P-value< 0.001). In addition, the balance in three reach directions improved significantly and the greatest balance improvement was in the anterior reach direction (β ranged over = 6.16 to 11.59) and the height of patients affected their balance (β = 0.28, P-value = 0.034).
CONCLUSIONS
Group (type of intervention), phase of intervention, reach direction of test (anterior, posteromedial and posterolateral) and height of participants were associated with balance performance. Static stretching exercise was more effective than muscle strengthening exercise in lengthened position for improving dynamic balance in low back pain patients with hamstring tightness.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials (I RCT201507258035n2 ). Registered 16th September 2015.",2020,"Static stretching exercise was more effective than muscle strengthening exercise in lengthened position for improving dynamic balance in low back pain patients with hamstring tightness.
","['patients with low back pain', 'low back pain subject with shortened hamstring', 'low back pain patients with hamstring tightness', 'Forty-five patients with hamstring shortening who referred to physiotherapy clinic of Kermanshah university of Medical Sciences, Kermanshah, Iran', 'patients with chronic low back pain with short hamstring muscles']","['Static stretching exercise', 'stretching exercise and strengthening exercise', 'static stretching and strengthening exercise', 'static stretching (n\u2009=\u200915), strengthening exercise in lengthened hamstring position', 'muscle strengthening exercise', 'conventional physiotherapy']",['dynamic balance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]","[{'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",45.0,0.0298587,"Static stretching exercise was more effective than muscle strengthening exercise in lengthened position for improving dynamic balance in low back pain patients with hamstring tightness.
","[{'ForeName': 'MohammadBagher', 'Initials': 'M', 'LastName': 'Shamsi', 'Affiliation': 'School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Mirzaei.m.epid92@gmail.com.'}, {'ForeName': 'Soodeh', 'Initials': 'S', 'LastName': 'Shahsavari', 'Affiliation': 'Department of Health Information Management, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Safari', 'Affiliation': 'Esfarayen Facualty of Medical Sciences, Esfarayen, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Saeb', 'Affiliation': 'Assistant professor of Orthopedic Surgery, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03823-z']
2724,33276744,Music therapy as social skill intervention for children with comorbid ASD and ID: study protocol for a randomized controlled trial.,"BACKGROUND
Autism spectrum disorder (ASD) is a developmental impairment characterized by persistent deficits in social communication and interactions, and over half of children with ASD possess below average intellectual ability (IQ < 85). The social development and response to social skill interventions among children with ASD and comorbid intellectual disability (ID) is not well understood. Music therapy is a systematic process of intervention, wherein a therapist may help clients promote their social skills by using musical experience. The proposed study will address limited research evidence on music therapy as an intervention for social functioning in children with ASD with mild to borderline ID.
METHOD
A randomized controlled trial (RCT) with two parallel groups of 40 children each (1:1 allocation ratio) is planned. Participants will receive 45 min of music therapy or non-musical intervention targeting social skills once a week for 12 weeks. Primary outcome measures will be independent ratings on the Childhood Autism Rating Scale and parent ratings on the Social Responsiveness Scale-2. Linear mixed-effects models for these two outcome measures will be created for data collected at 2-week pre-intervention, 2-week post-intervention, and 4-month post-intervention sessions. In-session behaviors at the first and last intervention will be videotaped and coded offline and compared. Pretreatment neural response of quantitative electroencephalograms (qEEG) to social scenes will be used to predict the outcomes of musical and non-musical social skill interventions, whereas qEEG responses to music will be used to predict the effectiveness of musical social skill intervention.
DISCUSSION
If neural markers of social skill development are found, then the long-term goal is to develop individualized intervention based on pre-treatment markers to maximize treatment efficacy. The proposed study's results may also suggest directions to development and provision of music therapy services in Hong Kong.
TRIAL REGISTRATION
ClinicalTrials.gov ( NCT04557488 ). Registered September 21, 2020.",2020,Primary outcome measures will be independent ratings on the Childhood Autism Rating Scale and parent ratings on the Social Responsiveness Scale-2.,"['children with ASD with mild to borderline ID', 'children with comorbid ASD and ID', '40 children each (1:1 allocation ratio) is planned', 'children with ASD and comorbid intellectual disability (ID', 'Autism spectrum disorder (ASD']","['45\u2009min of music therapy or non-musical intervention targeting social skills', 'social skill intervention', 'social skill interventions', 'Music therapy', 'quantitative electroencephalograms (qEEG']",['ratings on the Childhood Autism Rating Scale and parent ratings on the Social Responsiveness Scale-2'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0006009', 'cui_str': 'Borderline intellectual disability'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.104699,Primary outcome measures will be independent ratings on the Childhood Autism Rating Scale and parent ratings on the Social Responsiveness Scale-2.,"[{'ForeName': 'Yen Na', 'Initials': 'YN', 'LastName': 'Yum', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong SAR, China. yyum@eduhk.hk.'}, {'ForeName': 'Way Kwok-Wai', 'Initials': 'WK', 'LastName': 'Lau', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong SAR, China.'}, {'ForeName': 'Kean', 'Initials': 'K', 'LastName': 'Poon', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong SAR, China.'}, {'ForeName': 'Fuk Chuen', 'Initials': 'FC', 'LastName': 'Ho', 'Affiliation': 'Department of Special Education and Counselling, The Education University of Hong Kong, 10 Lo Ping Road, Tai Po, New Territories, Hong Kong SAR, China.'}]",BMC pediatrics,['10.1186/s12887-020-02454-6']
2725,33276738,Factors and HCV treatment outcomes associated with smoking among people who inject drugs on opioid agonist treatment: secondary analysis of the PREVAIL randomized clinical trial.,"BACKGROUND
Cigarette smoking has emerged as a leading cause of mortality among people with hepatitis C virus (HCV). People who inject drugs (PWID) represent the largest group of adults infected with HCV in the US. However, cigarette smoking remains virtually unexplored among this population. This study aimed at (1) determining prevalence and correlates of cigarette smoking among HCV-infected PWID enrolled in opiate agonist treatment programs; (2) exploring the association of smoking with HCV treatment outcomes including adherence, treatment completion and sustained virologic response (SVR); and 3) exploring whether cigarette smoking decreased after HCV treatment.
METHODS
Participants were 150 HCV-infected PWID enrolled in a randomized clinical trial primarily designed to test three intensive models of HCV care. Assessments included sociodemographics, presence of chronic health and psychiatric comorbidities, prior and current drug use, quality of life, and HCV treatment outcomes.
RESULTS
The majority of the patients (84%) were current cigarette smokers at baseline. There was a high prevalence of psychiatric and medical comorbidities in the overall sample of PWID. Alcohol and cocaine use were identified as correlates of cigarette smoking. Smoking status did not influence HCV treatment outcomes including adherence, treatment completion and SVR. HCV treatment was not associated with decreased cigarette smoking.
CONCLUSIONS
The present study showed high prevalence of cigarette smoking among this population as well as identified correlates of smoking, namely alcohol and cocaine use. Cigarette smoking was not associated with HCV treatment outcomes. Given the detrimental effects that cigarette smoking and other co-occurring, substance use behaviors have on HCV-infected individuals' health, it is imperative that clinicians treating HCV also target smoking, especially among PWID. The high prevalence of cigarette smoking among PWID will contribute to growing morbidity and mortality among this population even if cured of HCV. Tailored smoking cessation interventions for PWID along with HCV treatment may need to be put into clinical practice.
TRIAL REGISTRATION
NCT01857245 . Registered May 20, 2013.",2020,"Smoking status did not influence HCV treatment outcomes including adherence, treatment completion and SVR.","['people with hepatitis C virus (HCV', 'Participants were 150 HCV-infected PWID enrolled in a randomized clinical trial primarily designed to test three intensive models of HCV care', 'People who inject drugs (PWID) represent the largest group of adults infected with HCV in the US', 'people who inject drugs on opioid agonist treatment', 'HCV-infected PWID enrolled in opiate agonist treatment programs']",['HCV'],"['cigarette smoking', 'sociodemographics, presence of chronic health and psychiatric comorbidities, prior and current drug use, quality of life, and HCV treatment outcomes', 'adherence, treatment completion and SVR', 'Cigarette smoking', 'adherence, treatment completion and sustained virologic response (SVR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242402', 'cui_str': 'Opioid receptor agonist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]","[{'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}]",,0.0161501,"Smoking status did not influence HCV treatment outcomes including adherence, treatment completion and SVR.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'School of Health Research, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': 'Department of Public Health Sciences, College of Behavioral, Social, and Health Sciences, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Akiyama', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Brianna L', 'Initials': 'BL', 'LastName': 'Norton', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Agyemang', 'Affiliation': 'Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Jiajing', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'School of Mathematical and Statistical Sciences, College of Science, Clemson University, Clemson, SC, USA.'}, {'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'School of Health Research, Clemson University, Clemson, SC, USA. alain.litwin@prismahealth.org.'}]",BMC infectious diseases,['10.1186/s12879-020-05667-3']
2726,33276670,Influence of Photon-Induced Photoacoustic Streaming (PIPS) on Root Canal Disinfection and Post-Operative Pain: A Randomized Clinical Trial.,"The aim of this study was to evaluate the ability of a PIPS (photon-induced photoacoustic streaming) Er:YAG laser to reduce the root canal system bacterial count in vivo in comparison to the traditional irrigation technique. The post-operative patients' quality of life (QoL) after endodontic therapy was evaluated through a questionnaire. Fifty-four patients affected by pulp necrosis with or without apical periodontitis biofilm disease were selected for endodontic treatment and randomly assigned to Group A ( n = 27) with traditional irrigation and Group B ( n = 27), with PIPS irrigation applied according to the protocol. Shaping was performed with ProGlider and ProTaper Next, and irrigation was performed with 5% NaOCl and 10% EDTA. Intracanal samples for culture tests were collected before and after irrigation. The microbiological analysis was evaluated by the Kolmogorov-Smirnov normality and Mann-Whitney tests ( p < 0.05). A self-assessment questionnaire was used to evaluate the QoL during the 7 days after treatment; differences were analysed with Student's t -test. Irrigation with the PIPS device was significantly effective in reducing bacterial counts, which were higher for facultative than obligate anaerobic strains, particularly for Gram-negative bacteria, without statistical significance ( p > 0.05). There were no significant differences among the QoL indicators, except for the maximum pain ( p = 0.02), eating difficulty ( p = 0.03) and difficulty performing daily functions ( p = 0.02) in the first few days post-treatment. PIPS may represent an aid to root canal disinfection not affecting the patients' QoL, particularly for the first day after treatment.",2020,"Irrigation with the PIPS device was significantly effective in reducing bacterial counts, which were higher for facultative than obligate anaerobic strains, particularly for Gram-negative bacteria, without statistical significance ( p > 0.05).",['Fifty-four patients affected by pulp necrosis with or without apical periodontitis biofilm disease'],"['Photon-Induced Photoacoustic Streaming (PIPS', 'PIPS irrigation', 'PIPS (photon-induced photoacoustic streaming', 'traditional irrigation']","['Root Canal Disinfection and Post-Operative Pain', 'bacterial counts', 'difficulty performing daily functions', 'maximum pain', 'eating difficulty', 'quality of life (QoL']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0011407', 'cui_str': 'Necrosis of the pulp'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0086805', 'cui_str': 'Photon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518085', 'cui_str': 'Difficulty eating'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",54.0,0.0408721,"Irrigation with the PIPS device was significantly effective in reducing bacterial counts, which were higher for facultative than obligate anaerobic strains, particularly for Gram-negative bacteria, without statistical significance ( p > 0.05).","[{'ForeName': 'Narcisa', 'Initials': 'N', 'LastName': 'Mandras', 'Affiliation': 'Department of Public Health and Pediatrics, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Pasqualini', 'Affiliation': 'Department of Surgical Sciences, Dental School, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Janira', 'Initials': 'J', 'LastName': 'Roana', 'Affiliation': 'Department of Public Health and Pediatrics, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Tullio', 'Affiliation': 'Department of Public Health and Pediatrics, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Banche', 'Affiliation': 'Department of Public Health and Pediatrics, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gianello', 'Affiliation': 'Department of Surgical Sciences, Dental School, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Bonino', 'Affiliation': 'Department of Surgical Sciences, Dental School, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cuffini', 'Affiliation': 'Department of Public Health and Pediatrics, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Berutti', 'Affiliation': 'Department of Surgical Sciences, Dental School, University of Turin, 10126 Turin, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alovisi', 'Affiliation': 'Department of Surgical Sciences, Dental School, University of Turin, 10126 Turin, Italy.'}]",Journal of clinical medicine,['10.3390/jcm9123915']
2727,33276811,Safety and Efficacy of Ixekizumab and Antiviral Treatment for Patients with COVID-19: A structured summary of a study protocol for a Pilot Randomized Controlled Trial.,"OBJECTIVES
A severe epidemic of COVID-19 has broken out in China and has become a major global public health event. We focus on the Acute Respiratory Distress Syndrome (ARDS)-like changes and overactivation of Th17 cells (these produce cytokines) in patients with COVID-19. We aim to explore the safety and efficacy of ixekizumab (an injectable drug for the treatment of autoimmune diseases) to prevent organ injury caused by the immune response to COVID-19. Ixekizumab is a human monoclonal antibody that binds to interleukin-17A and inhibits the release of pro-inflammatory cytokines and chemokines.
TRIAL DESIGN
The experiment is divided into two stages. In the first stage, the open trial, 3 patients with COVID-19 are treated with ixekizumab, and the safety and efficacy are observed for 7 days. In the second stage, 40 patients with COVID-19 are randomly divided into two groups at 1:1 for 14 days. This is a two-center, open-label, randomized controlled pilot trial with 2-arm parallel group design (1:1 ratio).
PARTICIPANTS
Patients with COVID-19 aged 18-75 with increased Interleukin (IL)-6 levels will be enrolled, but patients with severe infections requiring intensive care will be excluded. The trial will be undertaken in two centers. The first stage is carried out in Xiangya Hospital of Central South University, and the second stage is carried out simultaneously in the Third Xiangya Hospital of Central South University.
INTERVENTION AND COMPARATOR
In the first stage, three subjects are given ixekizumab (""Taltz"") (80 mg/ml, 160 mg as a single hypodermic injection) and antiviral therapy (α-interferon (administer 5 million U by aerosol inhalation twice daily), lopinavir/ritonavir (administer 100mg by mouth twice daily, for the course of therapy no more than 10 days), chloroquine (administer 500mg by mouth twice daily, for the course of therapy no more than 10 days), ribavirin (administer 500mg by intravenous injection two to three times a day, for the course of therapy no more than 10 days), or arbidol (administer 200mg by mouth three times a day, for the course of therapy no more than 10 days), but not more than 3 types). The treatment course of the first stage is 7 days. In the second stage, 40 randomized patients will receive the following treatments--Group 1: ixekizumab (80 mg/ml, 160 mg as a single hypodermic injection) with antiviral therapy (the same scheme as in the first stage); Group 2: antiviral therapy alone (the same scheme as in the first stage). The length of the second treatment course is 14 days.
MAIN OUTCOMES
The primary outcome is a change in pulmonary CT severity score (an imaging tool for assessing COVID-19, which scores on the basis of all abnormal areas involved). Pulmonary CT severity score is assessed on the 7th day, 14th day, or at discharge.
RANDOMISATION
In the second stage, 40 patients with COVID-19 are randomly divided into two groups at 1:1 for 14 days. The eLite random system of Nanjing Medical University is used for randomization.
BLINDING (MASKING)
The main efficacy indicator, the CT results, will be evaluated by the third-party blinded and independent research team.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
In the second stage, 40 patients with COVID-19 are randomly divided into two groups at 1:1 for 14 days.
TRIAL STATUS
Trial registration number is ChiCTR2000030703 (version 1.7 as of March 19, 2020). The recruitment is ongoing, and the date recruitment was initiated in June 2020. The anticipated date of the end of data collection is June 2021.
TRIAL REGISTRATION
The name of the trial register is the Chinese Clinical Trial Registry. The trial registration number is ChiCTR2000030703 ( http://www.chictr.org.cn/ ). The date of trial registration is 10 March 2020.
FULL PROTOCOL
The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Ixekizumab is a human monoclonal antibody that binds to interleukin-17A and inhibits the release of pro-inflammatory cytokines and chemokines.
","['40 patients with COVID-19', 'Patients with COVID-19 aged 18-75 with increased Interleukin (IL)-6 levels will be enrolled, but patients with severe infections requiring intensive care will be excluded', 'patients with COVID-19', 'Patients with COVID-19']","['Ixekizumab and Antiviral Treatment', 'ixekizumab (""Taltz', 'antiviral therapy (α-interferon (administer 5 million U by aerosol inhalation twice daily), lopinavir/ritonavir', 'ribavirin', 'Ixekizumab', 'antiviral therapy alone', 'ixekizumab', 'chloroquine', 'antiviral therapy']","['safety and efficacy', 'change in pulmonary CT severity score (an imaging tool for assessing COVID-19, which scores on the basis of all abnormal areas involved', 'Pulmonary CT severity score', 'Safety and Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C4224872', 'cui_str': 'Taltz'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0001712', 'cui_str': 'Aerosol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}]",3.0,0.115051,"Ixekizumab is a human monoclonal antibody that binds to interleukin-17A and inhibits the release of pro-inflammatory cytokines and chemokines.
","[{'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'The Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Center for Clinical Pharmacology, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Mingzhu', 'Initials': 'M', 'LastName': 'Yin', 'Affiliation': 'The Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The Third Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Pinhua', 'Initials': 'P', 'LastName': 'Pan', 'Affiliation': 'The Respiratory Department, Xiangya Hospital, Central South University, 87 XiangYa Road, Changsha, 410008, Hunan, China. pinhuapan668@126.com.'}, {'ForeName': 'Yehong', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': 'The Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China. yh_927@126.com.'}]",Trials,['10.1186/s13063-020-04925-8']
2728,33276789,Interprofessional versus monoprofessional case-based learning in childhood cancer and the effect on healthcare professionals' knowledge and attitudes: study protocol for a randomised trial.,"BACKGROUND
Interprofessional education in childhood cancer is a multifaceted field involving multiple healthcare professionals with general and specialised knowledge and skills. Complex treatment, care and rehabilitation require continuous professional development and maintenance of healthcare professionals' competencies in their field of expertise. However, limited knowledge exists in comparing interprofessional and monoprofessional education. Only a few randomised studies have evaluated the effectiveness and efficiency of interprofessional education. The objective of this single-centre, investigator-initiated cluster randomised trial is to study the effect of interprofessional versus monoprofessional case-based learning on healthcare professionals' knowledge of gastrointestinal side effects and attitudes towards team collaboration.
METHODS
This study will randomise healthcare professionals to participate in either the experimental interprofessional group or the control monoprofessional group of case-based learning. The topic of the case-based intervention will be gastrointestinal side effects, one of six categories identified in a three-round Scandinavian Delphi study as relevant for interprofessional education in childhood cancer. The primary outcome is the self-reported questionnaire Assessment of Interprofessional Team Collaboration Scale. Secondary outcomes are measured by the self-reported questionnaires Readiness for Interprofessional Learning Scale Questionnaire, Safety Attitudes Questionnaire, and knowledge will be evaluated using a multiple-choice quiz. Participants will receive the self-reported questionnaires about 2 weeks before and 1 month after the intervention. On the day of the intervention, participants will answer a multiple-choice quiz before and after the case-based learning. Linear mixed models will be used to compare differences between the two groups in mean scores postintervention, adjusting for preintervention scores.
DISCUSSION
This study will provide insight into the differences between interprofessional and monoprofessional case-based learning and how it affects healthcare professionals' knowledge of gastrointestinal side effects and attitudes towards team collaboration.
TRIAL REGISTRATION
The intervention was registered at Clinical Trials.gov : NCT04204109 on December 102,019 and with the National Committee on Health Research Ethics: H-19087506 December 112,019 and the Danish Data Protection Agency: P-2019-637 October 152,019.",2020,This study will randomise healthcare professionals to participate in either the experimental interprofessional group or the control monoprofessional group of case-based learning.,[],"['Interprofessional versus monoprofessional case-based learning', 'interprofessional versus monoprofessional case-based learning', 'control monoprofessional group of case-based learning']","['self-reported questionnaires Readiness for Interprofessional Learning Scale Questionnaire, Safety Attitudes Questionnaire, and knowledge will be evaluated using a multiple-choice quiz', 'self-reported questionnaire Assessment of Interprofessional Team Collaboration Scale']",[],"[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0767608,This study will randomise healthcare professionals to participate in either the experimental interprofessional group or the control monoprofessional group of case-based learning.,"[{'ForeName': 'Martha Krogh', 'Initials': 'MK', 'LastName': 'Topperzer', 'Affiliation': 'Paediatric Oncology Research Laboratory, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark. martha.krogh.topperzer@regionh.dk.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Hanne Bækgaard', 'Initials': 'HB', 'LastName': 'Larsen', 'Affiliation': 'Paediatric Oncology Research Laboratory, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rosthøj', 'Affiliation': 'Section of Biostatistics, Faculty of Health Sciences, University of Copenhagen, Øster Farimagsgade 5, 1014, Copenhagen, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Nersting', 'Affiliation': 'Paediatric Oncology Research Laboratory, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Louise Ingerslev', 'Initials': 'LI', 'LastName': 'Roug', 'Affiliation': 'Paediatric Oncology Research Laboratory, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pontoppidan', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Andrés-Jensen', 'Affiliation': 'Paediatric Oncology Research Laboratory, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Birgitte', 'Initials': 'B', 'LastName': 'Lausen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Schmiegelow', 'Affiliation': 'Paediatric Oncology Research Laboratory, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Jette Led', 'Initials': 'JL', 'LastName': 'Sørensen', 'Affiliation': 'Juliane Marie Centre, Rigshospitalet and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}]",BMC health services research,['10.1186/s12913-020-05980-2']
2729,33276768,A randomized controlled TRIal of cognitive BEhavioral therapy for high Catastrophizing in patients undergoing lumbar fusion surgery: the TRIBECA study.,"BACKGROUND
Around 20% of patients undergoing spinal fusion surgery have persistent back or leg pain despite surgery. Pain catastrophizing is the strongest psychological predictor for chronic postsurgical pain. Psychological variables are modifiable and could be target for intervention. However, randomized controlled trials evaluating the effectiveness of psychological interventions to reduce chronic pain and disability after spinal fusion in a population of patients with high preoperative pain catastrophizing scores are missing. The aim of our study is to examine whether an intervention targeting pain catastrophizing mitigates the risk of chronic postsurgical pain and disability. Our primary hypothesis is that targeted perioperative cognitive behavioral therapy decreases the risk of chronic postsurgical pain and disability after spinal fusion surgery in high catastrophizing patients.
METHODS
We will perform a two-center prospective, single-blind, randomized, controlled study comparing lumbar spinal fusion surgery outcome between 2 cohorts. Adult patients selected for lumbar spinal fusion with decompression surgery and a minimum score of 24 on the pain catastrophizing scale will be randomized with 1:1 allocation for either perioperative cognitive behavioral therapy (intervention group) or a perioperative education plus progressive exercise program (control group). Patients randomized to the intervention group will receive six individual sessions of cognitive behavioral therapy, two sessions before the operation and four after. Primary outcome is the Core Outcome Measures Index at 12 months. Secondary outcomes include pain, disability, depression and quality of life.
DISCUSSION
This is the first trial that evaluates the effectiveness of cognitive behavioral therapy as a perioperative tool to improve pain and disability after spinal fusion surgery in comparison with an educational/exercise control intervention, in patients with high levels of pain catastrophizing. If perioperative cognitive behavioral therapy proves to be effective, this might have important clinical implications, reducing the incidence of chronic postsurgical pain and improving outcome after spinal fusion surgery.
TRIAL REGISTRATION
Clinicaltrials ( NCT03969602 ). Registered 31 May 2019.",2020,Adult patients selected for lumbar spinal fusion with decompression surgery and a minimum score of 24 on the pain catastrophizing scale will be randomized with 1:1 allocation for either perioperative cognitive behavioral therapy (intervention group) or a perioperative education plus progressive exercise program (control group).,"['patients undergoing lumbar fusion surgery', 'patients undergoing spinal fusion surgery have persistent back or leg pain despite surgery', 'Adult patients selected for lumbar spinal fusion with decompression surgery and a minimum score of 24 on the pain catastrophizing scale', 'patients with high levels of pain catastrophizing']","['educational/exercise control intervention', 'cognitive behavioral therapy', 'intervention group will receive six individual sessions of cognitive behavioral therapy', 'perioperative cognitive behavioral therapy (intervention group) or a perioperative education plus progressive exercise program (control group', 'psychological interventions', 'perioperative cognitive behavioral therapy', 'cognitive BEhavioral therapy']","['pain and disability', 'chronic pain and disability', 'pain, disability, depression and quality of life', 'chronic postsurgical pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]",,0.121895,Adult patients selected for lumbar spinal fusion with decompression surgery and a minimum score of 24 on the pain catastrophizing scale will be randomized with 1:1 allocation for either perioperative cognitive behavioral therapy (intervention group) or a perioperative education plus progressive exercise program (control group).,"[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Scarone', 'Affiliation': 'Neurosurgical Service, Neurocenter of Southern Switzerland, Lugano, Switzerland. Pietro.scarone@eoc.ch.'}, {'ForeName': 'A Y J M', 'Initials': 'AYJM', 'LastName': 'Smeets', 'Affiliation': 'Department of Neurosurgery, Zuyderland Medical Center, Heerlen/Sittard-Geleen, The Netherlands.'}, {'ForeName': 'S M J', 'Initials': 'SMJ', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'van Santbrink', 'Affiliation': 'Department of Neurosurgery, Zuyderland Medical Center, Heerlen/Sittard-Geleen, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Koetsier', 'Affiliation': 'Pain Management Center, Neurocenter of Southern Switzerland, Lugano, Switzerland.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03826-w']
2730,33276610,Minding the Gatekeepers: Referral and Recruitment of Postpartum Mothers with Depression into a Randomized Controlled Trial of a Mobile Internet Parenting Intervention to Improve Mood and Optimize Infant Social Communication Outcomes.,"Mothers in the United States (U.S.) who are of non-dominant culture and socioeconomically disadvantaged experience depression during postpartum at a rate 3 to 4 times higher than mothers in the general population, but these mothers are least likely to receive services for improving mood. Little research has focused on recruiting these mothers into clinical intervention trials. The purpose of this article is to report on a study that provided a unique context within which to view the differential success of three referral approaches (i.e., community agency staff referral, research staff referral, and maternal self-referral). It also enabled a preliminary examination of whether the different strategies yielded samples that differed with regard to risk factors for adverse maternal and child outcomes. The examination took place within a clinical trial of a mobile intervention for improving maternal mood and increasing parent practices that promote infant social communication development. The sample was recruited within the urban core of a large southern city in the U.S. and was comprised primarily of mothers of non-dominant culture, who were experiencing severe socioeconomic disadvantage. Results showed that mothers self-referred at more than 3.5 times the rate that they were referred by either community agency staff or research staff. Moreover, compared to women referred by research staff, women who self-referred and those who were referred by community gatekeepers were as likely to eventually consent to study participation and initiate the intervention. Results are discussed with regard to implications for optimizing referral into clinical intervention trials.",2020,It also enabled a preliminary examination of whether the different strategies yielded samples that differed with regard to risk factors for adverse maternal and child outcomes.,"['Postpartum Mothers with Depression', 'The sample was recruited within the urban core of a large southern city in the U.S. and was comprised primarily of mothers of non-dominant culture, who were experiencing severe socioeconomic disadvantage']","['Mobile Internet Parenting Intervention', 'mobile intervention']",[],"[{'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0475264,It also enabled a preliminary examination of whether the different strategies yielded samples that differed with regard to risk factors for adverse maternal and child outcomes.,"[{'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Baggett', 'Affiliation': 'Mark Chaffin Center for Healthy Development, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Sheeber', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Ammerman', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH 45229, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mosley', 'Affiliation': 'Mark Chaffin Center for Healthy Development, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Mark Chaffin Center for Healthy Development, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Feil', 'Affiliation': 'Oregon Research Institute, Eugene, OR 97403, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17238978']
2731,33276518,Effects of Oral Resveratrol Supplementation on Glycogen Replenishment and Mitochondria Biogenesis in Exercised Human Skeletal Muscle.,"The present study aimed to investigate the effect of oral resveratrol supplementation on the key molecular gene expressions involved in mitochondria biogenesis and glycogen resynthesis in human skeletal muscle. Nine young male athletes participated in the single-blind and crossover designed study. All subjects completed a 4-day resveratrol and placebo supplement in a randomized order while performing a single bout of cycling exercise. Immediately after the exercise challenge, the subjects consumed a carbohydrate (CHO) meal (2 g CHO/Kg body mass) with either resveratrol or placebo capsules. Biopsied muscle samples, blood samples and expired gas samples were obtained at 0 h and 3 h after exercise. The muscle samples were measured for gene transcription factor expression by real-time PCR for glucose uptake and mitochondria biogenesis. Plasma glucose, insulin, glycerol, non-esterified fatty acid concentrations and respiratory exchange ratio were analyzed during post-exercise recovery periods. The results showed that the muscle glycogen concentrations were higher at 3 h than at 0 h; however, there were no difference between resveratrol trial and placebo trial. There were no significantly different concentrations in plasma parameters between the two trials. Similarly, no measured gene expressions were significant between the two trials. The evidence concluded that the 4-day oral resveratrol supplementation did not improve post-exercise muscle glycogen resynthesis and related glucose uptake and mitochondrial biosynthesis gene expression in men.",2020,There were no significantly different concentrations in plasma parameters between the two trials.,"['men', 'Exercised Human Skeletal Muscle', 'human skeletal muscle', 'Nine young male athletes']","['oral resveratrol supplementation', 'Oral Resveratrol Supplementation', '4-day resveratrol and placebo supplement', 'resveratrol or placebo capsules', 'carbohydrate (CHO) meal']","['muscle glycogen concentrations', 'post-exercise muscle glycogen resynthesis and related glucose uptake and mitochondrial biosynthesis gene expression', 'Glycogen Replenishment and Mitochondria Biogenesis', 'Plasma glucose, insulin, glycerol, non-esterified fatty acid concentrations and respiratory exchange ratio', 'plasma parameters']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005495', 'cui_str': 'Genesis of Life'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",9.0,0.138183,There were no significantly different concentrations in plasma parameters between the two trials.,"[{'ForeName': 'Chun-Ching', 'Initials': 'CC', 'LastName': 'Huang', 'Affiliation': 'Department of Exercise and Health Sciences, National Taipei University of Nursing and Health Science, Taipei City 112, Taiwan.'}, {'ForeName': 'Chia-Chen', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': 'Department of Physical Education, National Taichung University of Education, Taichung City 403, Taiwan.'}, {'ForeName': 'Jung-Piao', 'Initials': 'JP', 'LastName': 'Tsao', 'Affiliation': 'Department of Physical Education, National Taichung University of Education, Taichung City 403, Taiwan.'}, {'ForeName': 'Chin-Lin', 'Initials': 'CL', 'LastName': 'Hsu', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University Hospital, Taichung 404, Taiwan.'}, {'ForeName': 'I-Shiung', 'Initials': 'IS', 'LastName': 'Cheng', 'Affiliation': 'Department of Physical Education, National Taichung University of Education, Taichung City 403, Taiwan.'}]",Nutrients,['10.3390/nu12123721']
2732,33276423,Redefining Non-Inferiority in Anamnestic Antibody Responses Using the Mean Increase of Log-Transformed Antibody Titers after Revaccination: Secondary Analysis of a Randomized Controlled Rabies Vaccination Trial.,"Non-inferiority in the anamnestic antibody response is conventionally determined by comparing seroconversion rates after revaccination. However, this approach is inadequate in the case of high pre-booster antibody titers. Therefore, we propose an alternative method to determine non-inferiority of booster responses. We used anonymized data from a randomized controlled trial (NCT01388985; EudraCT 2011-001612-62) in 500 adults, comparing a two-visit primary vaccination schedule (two intradermal 0.1 mL rabies vaccine doses on day 0 and 7) with a three-visit schedule (single intradermal 0.1 mL dose on day 0, 7, and 28). Participants were revaccinated intradermally (single dose) 1 to 3 years later. Rabies virus neutralizing antibody titers were measured on day 0 and 7 after revaccination. After log 3 -transformation of antibody titers, the mean increase in titers after revaccination was compared between schedules. Non-inferiority was defined as the lower bound of the two-sided 95% confidence interval not exceeding -0.369. Four hundred and ten participants fulfilled the inclusion criteria. The mean increase in log 3 titer was 2.21 and 2.31 for the two-visit and three-visit schedule, respectively. The difference between these increases was -0.10 [-0.28, 0.08], meeting the non-inferiority criterion. In conclusion, comparing mean increases in log-transformed titers after revaccination appears to be a feasible and more informative method of studying non-inferiority regarding the anamnestic antibody response.",2020,Non-inferiority in the anamnestic antibody response is conventionally determined by comparing seroconversion rates after revaccination.,"['Four hundred and ten participants fulfilled the inclusion criteria', '2011-001612-62) in 500 adults']","['two-visit primary vaccination schedule (two intradermal 0.1 mL rabies vaccine', 'EudraCT']",['mean increase in log 3 titer'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0034496', 'cui_str': 'Rabies vaccine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.141001,Non-inferiority in the anamnestic antibody response is conventionally determined by comparing seroconversion rates after revaccination.,"[{'ForeName': 'Lisanne A', 'Initials': 'LA', 'LastName': 'Overduin', 'Affiliation': 'Department of Immunology, Leiden University Medical Centre (LUMC), 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Patrick H P', 'Initials': 'PHP', 'LastName': 'Soentjens', 'Affiliation': 'Department of Clinical Sciences, Institute of Tropical Medicine, 2000 Antwerp, Belgium.'}, {'ForeName': 'Jelle J', 'Initials': 'JJ', 'LastName': 'Goeman', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Centre (LUMC), 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Magdalena A', 'Initials': 'MA', 'LastName': 'Berkowska', 'Affiliation': 'Department of Immunology, Leiden University Medical Centre (LUMC), 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Jacques J M', 'Initials': 'JJM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Immunology, Leiden University Medical Centre (LUMC), 2333 ZA Leiden, The Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre (LUMC), 2333 ZA Leiden, The Netherlands.'}]",Vaccines,['10.3390/vaccines8040721']
2733,33276345,Minimizing sedentary behavior (without increasing medium-to-vigorous exercise) associated functional improvement in older women is somewhat dependent on a measurable increase in muscle size.,"The optimal pattern of sedentarism displacement and mechanisms underlying its health effects are poorly understood. Therefore, the aim of this study was to quantify muscle-tendon adaptation in response to two different sedentarism displacement interventions and relate any adaptations to functional outcomes. Thirty-four older women (73±5yrs) underwent skeletal muscle-tendon size and functional assessments. Participants were randomly allocated to: Sedentary behaviour fragmentation (SBF), Light intensity physical activity (LIPA), or Control groups. Measures were taken at weeks 0 and 8. Gait speed significantly increased (p=0.003), in both experimental groups (SBF: 0.06 ± 0.08m/s, 6±10%, LIPA: 0.06 ± 0.07m/s, 6±6%), but not control (-0.02 ± 0.12m/s, -2±9%). Accordingly, the relative change in Vastus Lateralis muscle volume, accounted for 30% (p=0.027), and 45% (p=0.0006) of the explained variance in the relative change in gait speed, for SBF and LIPA respectively. Gastrocnemius Medialis fascicle length changes were positively associated with gait speed changes, following LIPA exclusively (R 2 = 0.50, p=0.009). This is the first study to show SBF and LIPA are adequate loading in older women, with related muscle adaptation and clinically relevant gait speed improvements. Such adaptations appear similar irrespective of whether sedentarism displacement is prescribed in a single bout (LIPA) or in frequent micro-bouts (SBF).",2020,"Gait speed significantly increased (p=0.003), in both experimental groups (SBF: 0.06 ± 0.08m/s, 6±10%, LIPA: 0.06 ± 0.07m/s, 6±6%), but not control (-0.02 ± 0.12m/s, -2±9%).","['older women', 'Thirty-four older women (73±5yrs) underwent skeletal muscle-tendon size and functional assessments']","['Sedentary behaviour fragmentation (SBF), Light intensity physical activity (LIPA), or Control groups', 'SBF and LIPA', 'Minimizing sedentary behavior (without increasing medium-to-vigorous exercise']","['Gastrocnemius Medialis fascicle length changes', 'Gait speed', 'relative change in Vastus Lateralis muscle volume']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",34.0,0.0426267,"Gait speed significantly increased (p=0.003), in both experimental groups (SBF: 0.06 ± 0.08m/s, 6±10%, LIPA: 0.06 ± 0.07m/s, 6±6%), but not control (-0.02 ± 0.12m/s, -2±9%).","[{'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Grant', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tomlinson', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""MRC Versus Arthritis Centre for Musculoskeletal Ageing Research, School of Life Sciences, Faculty of Medicine and Health Sciences, The University of Nottingham Medical School, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Kolić', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Onambélé-Pearson', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester, UK.'}]",Aging,['10.18632/aging.202265']
2734,33276255,"Effect of high protein and fat diet on postprandial blood glucose levels in children and adolescents with type 1 diabetes in Cairo, Egypt.","BACKGROUND AND AIMS
To determine the effect of high protein and high fat meals on post prandial glycemia in patients with type 1 diabetes.
METHODS
This study included 51 children and adolescents with type 1 diabetes who were following up at Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Abo Elrish Children's hospital, Cairo University. Post prandial blood glucose levels were recorded and compared following three breakfast meals with varying protein and fat content (standard carbohydrate meal, high fat meal, and high protein meal) over a period of 5 hours on 3 consecutive days.
RESULTS
High protein meal resulted in hyperglycemia with the peak level at 3.5 hours and continued for 5 hours post prandial while high fat meal caused early hyperglycemia reached the peak at 2 hours then declined towards 5 hours. Comparison of the three different breakfast meals revealed statistically significant difference regarding the postprandial glycemia at 30, 60, 90,120, 180, 210, 240, 270, 300 min.
CONCLUSION
Meals high in protein caused sustained increase in postprandial glucose levels over a period of 5 h. However, high fat meals caused early postprandial hyperglycemia. Protein and fat content of meals affect the timing and values of the peak blood glucose as well as the duration of postprandial hyperglycemia. Therefore, fat/protein unit should be taken in consideration while calculating the bolus insulin dose and anticipating the postprandial glucose response.",2020,"Comparison of the three different breakfast meals revealed statistically significant difference regarding the postprandial glycemia at 30, 60, 90,120, 180, 210, 240, 270, 300 min.
","['patients with type 1 diabetes', ""51 children and adolescents with type 1 diabetes who were following up at Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Abo Elrish Children's hospital, Cairo University"", 'children and adolescents with type 1 diabetes in Cairo, Egypt']","['high protein and fat diet', 'high protein and high fat meals']","['Post prandial blood glucose levels', 'hyperglycemia with the peak level', 'postprandial hyperglycemia', 'postprandial glycemia', 'Protein and fat content of meals affect the timing and values of the peak blood glucose', 'duration of postprandial hyperglycemia', 'postprandial glucose levels', 'postprandial blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0301585', 'cui_str': 'Fat diet'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0428569', 'cui_str': 'Post-prandial blood glucose measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",51.0,0.0158324,"Comparison of the three different breakfast meals revealed statistically significant difference regarding the postprandial glycemia at 30, 60, 90,120, 180, 210, 240, 270, 300 min.
","[{'ForeName': 'Marise', 'Initials': 'M', 'LastName': 'Abdou', 'Affiliation': 'Department of Pediatrics, Member of the Diabetes Endocrine and Metabolism Pediatric Unit (DEMPU), Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: Mariseabdou@gmail.com.'}, {'ForeName': 'Mona Hassan', 'Initials': 'MH', 'LastName': 'Hafez', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Children Hospital, Cairo University, Cairo, Egypt. Electronic address: mshereen57@yahoo.com.'}, {'ForeName': 'Ghada Mohammad', 'Initials': 'GM', 'LastName': 'Anwar', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Diabetes, Endocrine and Metabolism Pediatric Unit (DEMPU), Children Hospital, Cairo University, Cairo, Egypt. Electronic address: ghadaanwar@yahoo.co.uk.'}, {'ForeName': 'Wafaa Ahmed', 'Initials': 'WA', 'LastName': 'Fahmy', 'Affiliation': 'Head of Growth and Nutrient Requirements Department, National Nutrition Institute, Cairo, Egypt. Electronic address: drwafaa.fahmi@gmail.comNaglaa.'}, {'ForeName': 'Mohammed Abd', 'Initials': 'MA', 'LastName': 'Al Fattah', 'Affiliation': 'National Nutrition Institute, Cairo, Egypt. Electronic address: Naglaa.mhamed@yahoo.com.'}, {'ForeName': 'Rania Ibrahim', 'Initials': 'RI', 'LastName': 'Salem', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: dr_rania2@yahoo.com.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Arafa', 'Affiliation': 'Department of Pediatrics, Member of the Diabetes Endocrine and Metabolism Pediatric Unit (DEMPU), Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: Noha.hussein@kasralainy.edu.eg.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.11.020']
2735,33276251,"A new formulation of fluticasone propionate/salmeterol in a metered-dose inhaler (MDI HFA) allows for the reduction of a daily dose of corticosteroid and provides optimal asthma control - A randomized, multi-center, non-inferiority, phase IV clinical study.","BACKGROUND
Improvement of the delivery method of inhaled corticosteroids and subsequent dose reduction can minimize the risk of unfavorable outcomes while providing optimal asthma control.
OBJECTIVE
This randomized, multi-center, non-inferiority, phase IV clinical study compared the efficacy and safety of a new formulation of fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) administered in a metered-dose inhaler hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol (500 μg/50 μg, twice daily).
METHODS
Adults with asthma (n = 231) were randomly assigned to either the study group (treated for 12 weeks with fluticasone propionate/salmeterol MDI HFA) or a control group (treated for 12 weeks with fluticasone propionate/salmeterol DPI). Asthma symptoms, exacerbations, short-acting β 2 -agonist (SABA) use, physical activity, lung function, and general health status were assessed during four study visits.
RESULTS
Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity. Comparable improvement in peak expiratory flow ([MDI HFA] from 6.2 ± 0.2 to 6.6 ± 0.2 l/s vs. [DPI] from 6.0 ± 0.2 to 6.9 ± 0.2 l/s; p > 0.05), forced expiratory volume in one second, and forced vital capacity were obtained in both groups. Significantly lower incidence of hoarseness was observed in the study group ([MDI HFA] 0.0% vs. [DPI] 2.8%; p = 0.0267); no major differences were found for other adverse events.
CONCLUSIONS
Fluticasone propionate/salmeterol (250 μg/50 μg, twice daily) MDI HFA provides optimal asthma control and is non-inferior to fluticasone propionate/salmeterol (500 μg/50 μg, twice daily) DPI.",2020,"Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity.",['Adults with asthma (n = 231'],"['corticosteroid', 'Fluticasone propionate/salmeterol', 'fluticasone propionate/salmeterol ', 'fluticasone propionate/salmeterol DPI', 'MDI HFA', 'fluticasone propionate/salmeterol', 'fluticasone propionate/salmeterol MDI HFA', 'hydrofluoroalkane (MDI HFA) with a dry-powder inhaler (DPI) containing fluticasone propionate/salmeterol']","['peak expiratory flow ([MDI HFA', 'efficacy and safety', 'forced expiratory volume in one second, and forced vital capacity', 'Asthma symptoms, exacerbations, short-acting β 2 -agonist (SABA) use, physical activity, lung function, and general health status', 'incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity', 'incidence of hoarseness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C2723051', 'cui_str': 'salmeterol Dry Powder Inhaler'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0047120', 'cui_str': 'serotonin azidobenzamidine'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}]",231.0,0.160735,"Compared with the reference drug, the study drug decreased the incidence of daytime and night-time asthma symptoms, asthma exacerbations, self-administration of SABA, and the limitation of physical activity.","[{'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kupczyk', 'Affiliation': 'Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland. Electronic address: maciej.kupczyk@umed.lodz.pl.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Majak', 'Affiliation': 'Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Dept. of Internal Medicine, Asthma and Allergy, Medical University of Lodz, ul. Kopcinskiego 22, 90-153, Lodz, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Asankowicz-Bargiel', 'Affiliation': 'Asankowicz-Bargiel & Partners, Outpatient Specialist Clinic, ul. Pilsudskiego 33, 63-400, Ostrow Wielkopolski, Poland.'}, {'ForeName': 'Eliza', 'Initials': 'E', 'LastName': 'Barańska', 'Affiliation': 'Specialist Outpatient Clinic, ul. Wojska Polskiego 44, 64-800, Chodziez, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Dobek', 'Affiliation': 'Manamedica Medical Center, ul. Inwalidow Wojennych 13, 56-100, Wolow, Poland.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Garbicz', 'Affiliation': 'Pulmonology & Allergology Outpatient Clinic, ul. Hubalczykow 5, 76-200, Slupsk, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Jerzyńska', 'Affiliation': 'Amicare Research Center, ul. Zeligowskiego 46 lok. 10, 90-644, Lodz, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Latos', 'Affiliation': 'Artimed Medical Center, ul. Paderewskiego 4B, 25-017, Kielce, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Machowiak', 'Affiliation': 'Intermedius Medical Service, ul. Rynek 19, 64-000, Koscian, Poland.'}, {'ForeName': 'Bernadetta', 'Initials': 'B', 'LastName': 'Majorek-Olechowska', 'Affiliation': 'Alergomed Medical Center, ul. PCK 26, 33-100, Tarnow, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Olech-Cudzik', 'Affiliation': 'Ostrowiec Medical Center, ul. Ilzecka 31a, 27-400, Ostrowiec Sw., Poland.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Poziomkowska-Gęsicka', 'Affiliation': 'Dept of Clinical Allergology, Pomeranian Medical University of Szczecin, ul. Powstancow Wlkp. 72, 70-111, Szczecin, Poland.'}, {'ForeName': 'Mirosława', 'Initials': 'M', 'LastName': 'Rulewicz-Warniełło', 'Affiliation': 'Specialist Outpatient Clinic for Pulmonary Diseases, ul. Krotka 4, 11-400, Ketrzyn, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Świderska', 'Affiliation': 'Allergology Outpatient Clini, ul. Joanny Zubr 18, 98-300, Wielun, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Tarnowski', 'Affiliation': 'Pharmaceutical Company LEK-AM, Al. Jana Pawła II 80, 00-175, Warszawa, Poland.'}, {'ForeName': 'Przemysław', 'Initials': 'P', 'LastName': 'Kopyto', 'Affiliation': 'QAH CRO, ul. Stefana Skrzywana 6, 93-588, Lodz, Poland.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106274']
2736,33276225,"Effect of adding motor imagery training to neck stabilization exercises on pain, disability and kinesiophobia in patients with chronic neck pain.","PURPOSE
The investigation of this study was to compare the effect of adding motor imagery training to neck stabilization exercises on pain, disability, and kinesiophobia in patients with chronic neck pain.
MATERIAL AND METHODS
After screening, seventy-two volunteers with chronic neck pain were randomly allocated to 3 groups: neck stabilization exercises alone, n = 24, combined ( neck stabilization exercises + motor imagery training), n = 24, and a control group, n = 24. Pain intensity, disability, and kinesiophobia before and after the intervention exercises were measured by the Visual Analog Scale, Neck Disability Index, and the Tampa Scale of Kinesiophobia , respectively.
RESULTS
Statistically significant differences in pain intensity, the neck disability index, and kinesiophobia were found when a combined intervention group including neck stabilization and motor imagery training was compared with neck stabilization training alone at 6 weeks ) p ≤ 0.005). Also, there were significant between-group differences favoring experimental groups versus control for all outcomes (p ≤ 0.001).
CONCLUSION
neck stabilization exercises in combination with motor imagery training was superior to neck stabilization exercises alone in decreasing pain, disability, and kinesiophobia in patients with chronic neck pain.",2020,"Statistically significant differences in pain intensity, the neck disability index, and kinesiophobia were found when a combined intervention group including neck stabilization and motor imagery training was compared with neck stabilization training alone at 6 weeks )","['After screening, seventy-two volunteers with chronic neck pain', 'patients with chronic neck pain']","['motor imagery training to neck stabilization exercises', 'neck stabilization exercises', 'neck stabilization exercises alone, n\xa0=\xa024, combined ( neck stabilization exercises\xa0+\xa0motor imagery training), n\xa0=\xa024, and a control group, n\xa0=\xa024']","['Pain intensity, disability, and kinesiophobia', 'Visual Analog Scale, Neck Disability Index, and the Tampa Scale of Kinesiophobia , respectively', 'pain, disability, and kinesiophobia', 'pain intensity, the neck disability index, and kinesiophobia', 'neck stabilization and motor imagery training', 'pain, disability and kinesiophobia']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",72.0,0.0207621,"Statistically significant differences in pain intensity, the neck disability index, and kinesiophobia were found when a combined intervention group including neck stabilization and motor imagery training was compared with neck stabilization training alone at 6 weeks )","[{'ForeName': 'Norollah', 'Initials': 'N', 'LastName': 'Javdaneh', 'Affiliation': 'Department of Biomechanics and Sport Medicine, Kharazmi University, Tehran, Iran. Electronic address: njavdaneh68@gmail.com.'}, {'ForeName': 'Feridon', 'Initials': 'F', 'LastName': 'Molayei', 'Affiliation': 'Iran University of Medical Sciences & Physiotherapy Center of Ahangesalamati, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Kamranifraz', 'Affiliation': 'Iran University of Medical Sciences & Physiotherapy Center of Ahangesalamati, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101263']
2737,33276036,Oscillatory entrainment of neural activity between inferior frontoparietal cortices alters imitation performance.,"The frontoparietal mirror network is activated when an individual performs a goal-directed action and observes another person's intentional action. It has been speculated that the distinct frontal and parietal regions might work together to participate in the imitation process, which translates an observed movement into an identical action. We aimed to determine the relationship between the frontoparietal mirror network and imitation by applying transcranial alternating current stimulation (tACS) to exogenously modulate oscillatory neural activity in the left inferior frontal gyrus and the left inferior parietal lobule. In total, 45 young adults participated in this study. The participants were randomly assigned to the three tACS groups (synchronous, desynchronous, and sham; 55 Hz enveloped by 6 Hz). Before and during tACS, the participants performed the gesture matching task and the gesture imitation task. Application of synchronous tACS over the left frontoparietal cortices significantly improved the performance of gesture matching and the meaningless gesture imitation relative to the baseline performance. Desynchronous tACS deteriorated the gesture matching performance relative to the baseline results. The oscillatory entrainment of neural activity between components of the frontoparietal mirror network is considered to alter imitation performance by modulating neural information relating to the goals of actions in the frontal cortex and the means of observed actions in the parietal cortex. To the best of our knowledge, this is the first study that reveals that the rhythmic communication between components of the frontoparietal mirror network has a functional role in imitation.",2020,Application of synchronous tACS over the left frontoparietal cortices significantly improved the performance of gesture matching and the meaningless gesture imitation relative to the baseline performance.,['45 young adults participated in this study'],"['gesture matching task and the gesture imitation task', 'tACS groups (synchronous, desynchronous, and sham; 55 Hz enveloped by 6 Hz', 'transcranial alternating current stimulation (tACS']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]",[],45.0,0.0212143,Application of synchronous tACS over the left frontoparietal cortices significantly improved the performance of gesture matching and the meaningless gesture imitation relative to the baseline performance.,"[{'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Physical Therapy, Akita University Graduate School of Health Sciences.'}, {'ForeName': 'Yoshino', 'Initials': 'Y', 'LastName': 'Terui', 'Affiliation': 'Department of Physical Therapy, Akita University Graduate School of Health Sciences.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Izumi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tohoku University Graduate School of Medicine.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107702']
2738,33276013,INSIGHT responsive parenting intervention effects on child appetite and maternal feeding practices through age 3 years.,"Expert guidance encourages interventions promoting structure-based practices to establish predictable eating environments in order to foster children's self-regulatory skills. However, few studies have examined whether and how child characteristics may moderate effects of interventions on maternal feeding practices. This analysis aimed to examine the effect of the INSIGHT Responsive Parenting (RP) intervention delivered largely during infancy, on child appetitive traits at 2.5 years and maternal feeding practices at 3 years. Primiparous mother-newborn dyads were randomized to a RP intervention designed for obesity prevention or a safety control intervention. Mothers completed the Child Eating Behavior Questionnaire at 2.5 years and the Structure and Control in Parent Feeding Questionnaire at 3 years. T-tests assessed study group differences on child appetitive traits at 2.5 years and maternal feeding practices at age 3. ANCOVA models assessed the effect of study group on parent feeding practices and tested appetitive traits as a moderator. Two hundred thirty-two mother-child dyads completed the trial. Mothers were predominantly white, non-Hispanic, college educated, and married. RP group mothers used more consistent meal routines, and less pressure, food to soothe, and food as reward compared to controls. Child satiety responsiveness moderated the RP intervention effect on maternal use of limiting exposure to unhealthy foods such that the RP intervention was most effective for children at higher levels of satiety responsiveness. Food responsiveness moderated RP intervention effects on the use of pressure-based feeding practices such that at lower levels of food responsiveness, control group mothers used more pressure than RP mothers. The INSIGHT RP intervention demonstrated sustained effects on maternal feeding practices through age 3 years, with some intervention effects showing moderation by child appetitive traits.",2020,"The INSIGHT RP intervention demonstrated sustained effects on maternal feeding practices through age 3 years, with some intervention effects showing moderation by child appetitive traits.","['child appetite and maternal feeding practices through age 3 years', 'Mothers were predominantly white, non-Hispanic, college educated, and married', 'Two hundred thirty-two mother-child dyads completed the trial', 'Primiparous mother-newborn dyads']","['RP intervention', 'INSIGHT Responsive Parenting (RP) intervention', 'INSIGHT RP intervention', 'RP intervention designed for obesity prevention or a safety control intervention']","['Child Eating Behavior Questionnaire', 'consistent meal routines, and less pressure, food to soothe, and food as reward', 'child appetitive traits']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0392339', 'cui_str': 'Eating routine'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]",232.0,0.0227995,"The INSIGHT RP intervention demonstrated sustained effects on maternal feeding practices through age 3 years, with some intervention effects showing moderation by child appetitive traits.","[{'ForeName': 'Cara F', 'Initials': 'CF', 'LastName': 'Ruggiero', 'Affiliation': 'Center for Childhood Obesity Research, 129 Noll Laboratory the Pennsylvania State University University Park, PA, 16802, USA; Nutritional Sciences, 110 C Chandlee Laboratory the Pennsylvania State University University Park, PA, 16802, USA. Electronic address: cfr8@psu.edu.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hohman', 'Affiliation': 'Center for Childhood Obesity Research, 129 Noll Laboratory the Pennsylvania State University University Park, PA, 16802, USA. Electronic address: eeh12@psu.edu.'}, {'ForeName': 'Leann L', 'Initials': 'LL', 'LastName': 'Birch', 'Affiliation': 'Foods and Nutrition 280 Dawson Hall 305 Sanford Dr. University of Georgia Athens, GA 30602, USA. Electronic address: llb15@uga.edu.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Paul', 'Affiliation': 'Pediatrics and Public Health Sciences 500 University Drive Penn State College of Medicine Hershey, PA 17033, USA. Electronic address: ipaul@pennstatehealth.psu.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'Center for Childhood Obesity Research, 129 Noll Laboratory the Pennsylvania State University University Park, PA, 16802, USA; Nutritional Sciences, 110 C Chandlee Laboratory the Pennsylvania State University University Park, PA, 16802, USA. Electronic address: jfs195@psu.edu.'}]",Appetite,['10.1016/j.appet.2020.105060']
2739,33275985,Autophagy blockade mechanistically links proton pump inhibitors to worsened diabetic nephropathy and aborts the renoprotection of metformin/enalapril.,"AIM
Proton pump inhibitors (PPIs) are widely used drugs recently linked to chronic kidney disease. However, mechanisms remained elusive. Since defective autophagy is identified as a new culprit in the pathogenesis of diabetic nephropathy (DN), we aimed to trace the link of autophagy blockade by PPIs to the progression of DN with and without the standard therapy of metformin and enalapril.
MAIN METHODS
Male CD1 albino mice (20-25 g) were randomly assigned to normal control or diabetic mice. Diabetes was induced by intraperitoneal streptozotocin (35 mg/kg) injection combined with high fat diet. DN mice were randomized to receive vehicle, lansoprazole (5 mg/kg), metformin (200 mg/kg), lansoprazole + metformin, metformin + enalapril (0.5 mg/kg) or the three drugs together, orally daily for four weeks. At the study end, albuminuria, fasting plasma glucose, HbA1c, renal functions and malondialdehyde were assessed. Renal tissues were examined microscopically, and autophagic changes were evaluated by immunohistochemical detection of LC3-II and p62.
KEY FINDINGS
Consistent with autophagic blockade, lansoprazole increased both LC3II and p62 in the glomerular and tubular cells. This was associated with impaired creatinine clearance and renal functions, enhanced albuminuria, oxidative stress and augmented DN histopathological changes. Opposite effects on autophagy markers were observed by single or combined treatment of metformin with enalapril; which also ameliorated glycemic control and signs of DN. This improvement was mitigated by combination with lansoprazole.
SIGNIFICANCE
Autophagy blockade by lansoprazole augmented diabetic nephropathy and opposed the reno-protective effects of metformin and enalapril. The use of PPIs in diabetes should be considered with great caution.",2020,"At the study end, albuminuria, fasting plasma glucose, HbA1c, renal functions and malondialdehyde were assessed.",['Male CD1 albino mice (20-25\u202fg'],"['Proton pump inhibitors (PPIs', 'intraperitoneal streptozotocin (35\u202fmg/kg) injection combined with high fat diet', 'metformin with enalapril', 'metformin', 'metformin/enalapril', 'vehicle, lansoprazole', 'lansoprazole', 'metformin and enalapril', 'normal control or diabetic mice', 'lansoprazole\u202f+\u202fmetformin, metformin\u202f+\u202fenalapril']","['autophagy markers', 'creatinine clearance and renal functions, enhanced albuminuria, oxidative stress and augmented DN histopathological changes', 'glycemic control and signs of DN', 'albuminuria, fasting plasma glucose, HbA1c, renal functions and malondialdehyde', 'glomerular and tubular cells']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0054941', 'cui_str': 'Lymphocyte antigen CD1'}, {'cui': 'C0001916', 'cui_str': 'Albinism'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0456638', 'cui_str': '25G'}]","[{'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0038432', 'cui_str': 'Streptozocin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0050940', 'cui_str': 'lansoprazole'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}]","[{'cui': 'C0004391', 'cui_str': 'Autophagocytosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0022663', 'cui_str': 'Glomerulus structure'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]",,0.0210856,"At the study end, albuminuria, fasting plasma glucose, HbA1c, renal functions and malondialdehyde were assessed.","[{'ForeName': 'Dalia Kamal', 'Initials': 'DK', 'LastName': 'Mostafa', 'Affiliation': 'Department of Clinical Pharmacology, Faculty of Medicine, Alexandria University, Alexandria, Egypt. Electronic address: dalia.kashishy@alexmed.edu.eg.'}, {'ForeName': 'Mohamed Mostafa', 'Initials': 'MM', 'LastName': 'Khedr', 'Affiliation': 'Department of Clinical Pharmacology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mervat Kamel', 'Initials': 'MK', 'LastName': 'Barakat', 'Affiliation': 'Department of Clinical Pharmacology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Amany Abdelbari', 'Initials': 'AA', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Pathology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Amal Mohamed', 'Initials': 'AM', 'LastName': 'Elsharkawy', 'Affiliation': 'Department of Clinical Pharmacology, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}]",Life sciences,['10.1016/j.lfs.2020.118818']
2740,33275962,Proximal Versus Distal Approach of Ultrasonographic-Guided Suprascapular Nerve Block for patients with adhesive capsulitis of the shoulder (Prospective Randomized Clinical Trial).,"OBJECTIVE
This study was to evaluate the early clinical outcomes of ultrasound (US)-guided suprascapular nerve block(SSNB) using proximal approach compared to those of distal approach for outpatient treatment of adhesive capsulitis.
DESIGN
Randomized Controlled Clinical Trial SETTING: Outpatient clinic PARTICIPANTS: A total of 47 participants with symptomatic adhesive capsulitis were assigned.
INTERVENTIONS
The participants were randomly assigned to either US-guided SSNB using proximal approach (N=23, proximal group) or distal approach (N=24, distal group).
MAIN OUTCOME MEASURES
The primary outcome measure was the visual analogue scale(VAS) for pain at week 12 and the secondary outcomes included the American Shoulder Elbow Surgeon's(ASES) score, University California Los Angeles score, 36 health survey questionnaire mental component summary, physical component summary and range of motion. All patients completed clinical follow-up at 2 weeks, 6 weeks and 12 weeks after treatment. On ultrasound images, depth and insertion angle of needle during injection were measured.
RESULTS
The VAS significantly improved in both groups at week 12. After treatment, no significant differences were found in early clinical outcomes (at weeks 2,6 and 12) between groups (all in p>.05), except ASES at 2 weeks showing significantly higher score in distal group, than in proximal group (87.1±4.8 and 83.0±6.3 respectively, p=0.014). The mean depth and insertion angle of needle was significantly lower (depth, 13.4±3.9 mm and 30.6±,4.3 mm, p<0.001 and insertion angle, 19.6°±6.4 and 38.7°±5.8, p<0.001) in proximal group than distal group.
CONCLUSIONS
This study demonstrated that proximal approach of US-guided SSNB provided favorable short-term outcomes of pain and functional improvement, and outcomes were comparable to those of distal approach in adhesive capsulitis. The SSN was located more superficially and easily identified in proximal approach, suggesting that it might improve the accuracy of injection.",2020,"After treatment, no significant differences were found in early clinical outcomes (at weeks 2,6 and 12) between groups (all in p>.05), except ASES at 2 weeks showing significantly higher score in distal group, than in proximal group (87.1±4.8 and 83.0±6.3 respectively, p=0.014).","['47 participants with symptomatic adhesive capsulitis were assigned', 'patients with adhesive capsulitis of the shoulder']","['ultrasound (US)-guided suprascapular nerve block(SSNB', 'Proximal Versus Distal Approach of Ultrasonographic-Guided Suprascapular Nerve Block', 'US-guided SSNB using proximal approach (N=23, proximal group) or distal approach']","['visual analogue scale(VAS) for pain', 'VAS', 'early clinical outcomes', 'mean depth and insertion angle of needle', ""American Shoulder Elbow Surgeon's(ASES) score, University California Los Angeles score, 36 health survey questionnaire mental component summary, physical component summary and range of motion""]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0228878', 'cui_str': 'Structure of suprascapular nerve'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0394703', 'cui_str': 'Injection of anesthetic agent into suprascapular nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",47.0,0.188864,"After treatment, no significant differences were found in early clinical outcomes (at weeks 2,6 and 12) between groups (all in p>.05), except ASES at 2 weeks showing significantly higher score in distal group, than in proximal group (87.1±4.8 and 83.0±6.3 respectively, p=0.014).","[{'ForeName': 'Kyu Hwan', 'Initials': 'KH', 'LastName': 'Bae', 'Affiliation': 'Department of Orthopaedic Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ki Chol', 'Initials': 'KC', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Gu Min', 'Initials': 'GM', 'LastName': 'Jeong', 'Affiliation': 'Department of Orthopaedic Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Tae Kang', 'Initials': 'TK', 'LastName': 'Lim', 'Affiliation': 'Department of Orthopaedic Surgery, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea. Electronic address: shouldertk@gmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.11.003']
2741,33275913,Optical diagnosis of colorectal polyps: a randomized controlled trial comparing endoscopic image enhancing modalities.,"BACKGROUND AND AIMS
Optical polyp diagnosis using image enhancing endoscopy (IEE) allows for real-time histology prediction of colorectal polyps. The aim of this study was to evaluate a recently introduced IEE modality (Optivista) in a randomized controlled trial.
METHODS
In a prospective cohort of subjects (age 45-80 years) undergoing elective screening, surveillance, or diagnostic colonoscopy all colorectal polyps between 1 to 5 mm underwent IEE assessment. Study subjects were randomized before their colonoscopy procedure to undergo optical polyp diagnosis either using Optivista (OV) IEE or iScan (IS) IEE. A validated IEE scale (NICE classification) was used for optical polyp diagnosis. Primary outcome was the agreement of surveillance intervals determined when using OV IEE compared with IS IEE in reference with pathology-based surveillance intervals. Secondary outcomes included the percentage of surveillance intervals that could be given on the same day as the procedure, percentage of pathology tests avoided, diagnostic performance, and negative predictive value (NPV) of optical diagnosis for rectosigmoid adenomas.
RESULTS
A total of 410 patients were enrolled in the trial. The polyp detection rate was 58.6% and the adenoma detection rate was 38.8%. The proportion of correct surveillance interval assignment when using OV IEE or IS was 96.5% versus 96.0% (p=0.75). A total of 65.1% of patients could be given same-day surveillance intervals when using OV IEE versus 73.1% for IS (p=0.07). The NPV for rectosigmoid adenomas (including SSAs) was 97.5% when using OV IEE and 88.2% when using IS IEE. Using high-confidence optical diagnosis instead of pathology would have resulted in a 44.3% elimination of required pathology examinations for OV IEE versus 52.8% for IS (p=0.34).
CONCLUSION
Optical diagnosis using OV IEE and IS both surpassed the 90% benchmark of surveillance interval assignment, and no significant difference with regard to correct surveillance interval assignment was found. OV IEE surpassed the ≥90% NPV for rectosigmoid adenomas whereas IS did not.",2020,The NPV for rectosigmoid adenomas (including SSAs) was 97.5% when using OV IEE and 88.2% when using IS IEE.,"['subjects (age 45-80 years) undergoing elective screening, surveillance, or diagnostic colonoscopy', 'colorectal polyps', '410 patients were enrolled in the trial']","['colonoscopy procedure to undergo optical polyp diagnosis either using Optivista (OV) IEE or iScan (IS) IEE', 'image enhancing endoscopy (IEE']","['adenoma detection rate', 'agreement of surveillance intervals', 'polyp detection rate', 'percentage of surveillance intervals that could be given on the same day as the procedure, percentage of pathology tests avoided, diagnostic performance, and negative predictive value (NPV) of optical diagnosis for rectosigmoid adenomas']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0400018', 'cui_str': 'Diagnostic endoscopic examination on colon'}, {'cui': 'C0949059', 'cui_str': 'Polyp of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2242630', 'cui_str': 'Pathology test'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0521377', 'cui_str': 'Rectosigmoid structure'}]",410.0,0.12731,The NPV for rectosigmoid adenomas (including SSAs) was 97.5% when using OV IEE and 88.2% when using IS IEE.,"[{'ForeName': 'Roupen', 'Initials': 'R', 'LastName': 'Djinbachian', 'Affiliation': 'Division of Internal Medicine, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Marchand', 'Affiliation': 'University of Montreal, Faculty of Medicine and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Pohl', 'Affiliation': 'Department of Veterans Affairs Medical Center, White River Junction, Vermont, and Dartmouth Geisel, School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Aguilera-Fish', 'Affiliation': 'Department of Veterans Affairs Medical Center, White River Junction, Vermont, and Dartmouth Geisel, School of Medicine, Hanover, New Hampshire, USA.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Bouin', 'Affiliation': 'Division of Gastroenterology, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada.'}, {'ForeName': 'Érik', 'Initials': 'É', 'LastName': 'Deslandres', 'Affiliation': 'Division of Gastroenterology, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Weber', 'Affiliation': 'Division of Gastroenterology, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Division of Gastroenterology, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Panzini', 'Affiliation': 'Division of Gastroenterology, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'von Renteln', 'Affiliation': 'Division of Gastroenterology, Montreal University Hospital Center (CHUM) and Montreal University Hospital Research Center (CRCHUM), Montreal, Canada. Electronic address: renteln@gmx.net.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.11.023']
2742,33275819,REMeDio: a proof-of-concept neuroprotection study for prodromal synucleinopathies.,"OBJECTIVE
To explore the feasibility of a neuroprotection trial in prodromal synucleinopathy, using idiopathic REM sleep behavior disorder (iRBD) as the target population and 123 I-FP-CIT-SPECT as a biomarker of disease progression.
METHODS
Consecutive iRBD patients were randomly assigned to a treatment arm, receiving selegiline and symptomatic RBD treatment, or to a control arm, receiving symptomatic treatment only. Selegiline was chosen because of a demonstrated neuroprotection effect in animal models. Patients underwent 123 I-FP-CIT-SPECT at baseline and after 30 months in average. The clinical outcome was the emergence of parkinsonism and/or dementia. A repeated-measures general linear model (GLM) was applied, using group (control and treatment) as 'between' factor, and both time (baseline and follow-up) and regions ( 123 I-FP-CIT-SPECT putamen and caudate uptake) as 'within' factors, adjusting for age.
RESULTS
Thirty iRBD patients completed the study (68.2±6.9 years; 29 males; 21% drop-out rate), 13 in the treatment arm and 17 in the control arm. At follow-up (29.8±9.0 months), three patients in the control arm developed dementia and one parkinsonism while two patients in the treatment arm developed parkinsonism. Both putamen and caudate uptake decreased over time in the control arm. In the treatment arm, only the putamen uptake decreased over time while caudate uptake remained stable. GLM analysis demonstrated an effect of treatment on the 123 I-FP-CIT-SPECT uptake change, with a significant interaction between the effect of group, time and regions (p=0.004).
CONCLUSION
A 30-months neuroprotection study for prodromal synucleinopathy is feasible, using iRBD as the target population, and 123 I-FP-CIT-SPECT as a biomarker of disease progression.",2020,Both putamen and caudate uptake decreased over time in the control arm.,"['Consecutive iRBD patients', 'Thirty iRBD patients completed the study (68.2±6.9 years; 29 males; 21% drop-out rate), 13 in the treatment arm and 17 in the control arm']","['REMeDio', 'selegiline and symptomatic RBD treatment, or to a control arm, receiving symptomatic treatment only']","['dementia and one parkinsonism', 'emergence of parkinsonism and/or dementia']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0751772', 'cui_str': 'REM sleep behavior disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036579', 'cui_str': 'Selegiline'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0242422', 'cui_str': 'Parkinsonism'}]",123.0,0.025836,Both putamen and caudate uptake decreased over time in the control arm.,"[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Arnaldi', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Famà', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Girtler', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Brugnolo', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Pardini', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Mattioli', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Meli', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Massa', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Orso', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Sormani', 'Affiliation': 'Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Maria Isabella', 'Initials': 'MI', 'LastName': 'Donegani', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bauckneht', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Morbelli', 'Affiliation': 'IRCCS Ospedale Policlinico San Martino, Genoa, Italy.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Nobili', 'Affiliation': 'Clinical Neurology Dept. of Neuroscience (DINOGMI), University of Genoa, Italy, Genova.'}]",European journal of neurology,['10.1111/ene.14664']
2743,33275811,Dissonance-based eating disorder prevention delivered in-person after an online training: A randomized controlled trial for Brazilian men with body dissatisfaction.,"OBJECTIVE
Few prevention programs have been developed and empirically evaluated to address eating disorder (ED) and muscle dysmorphia (MD) symptoms in men. Furthermore, new strategies for the broad implementation of available programs are needed. We investigated the acceptability and efficacy of a dissonance-based (DB) intervention for Brazilian undergraduate men with body dissatisfaction to target risk and protective factors for ED and MD symptoms (the Body Project: More Than Muscles) after an online training for facilitators.
METHOD
Participants were randomized to a two-session DB-intervention (n = 89) or assessment-only control (AOC) (n = 91), and completed validated measures assessing ED and MD risk and protective factors pre-intervention, post-intervention, and at 4- and 24-week follow-up post-intervention.
RESULTS
Acceptability ratings were highly favorable. Regarding efficacy, the DB condition demonstrated significantly greater decreases in ED and MD risk factors compared to AOC from pre-intervention to 4-week (p-values <.05, between-condition Cohen's d = 0.35-1.10) and 24-week follow-up (p-values <.05, between-condition Cohen's d = 0.33-0.78). Results at post-intervention were not significant, with the exception that body appreciation showed significantly greater improvements in the DB condition (post-intervention: p < .01, between-condition Cohen's d = 0.40; 4-week: p < .001, between-condition Cohen's d = 0.80; and 24-week follow-up: p < .001, between-condition Cohen's d = 0.58).
DISCUSSION
Results support the acceptability and efficacy of a DB-intervention delivered in-person after an online training for facilitators up to 24-week follow-up in Brazilian men.",2020,"Results at post-intervention were not significant, with the exception that body appreciation showed significantly greater improvements in the DB condition (post-intervention: p < .01, between-condition Cohen's d = 0.40; 4-week: p < .001, between-condition Cohen's d = 0.80; and 24-week follow-up: p < .001, between-condition Cohen's d = 0.58).
","['Brazilian men with body dissatisfaction', 'Participants', 'Brazilian undergraduate men with body dissatisfaction to target risk and protective factors for ED and MD symptoms (the Body Project: More Than Muscles) after an online training for facilitators']","['session DB-intervention (n =\u200989) or assessment-only control (AOC) (n =\u200991), and completed validated measures assessing ED and MD risk and protective factors pre-intervention, post-intervention, and at 4- and 24-week follow-up post-intervention', 'Dissonance-based eating disorder prevention delivered in-person after an online training', 'dissonance-based (DB) intervention', 'DB-intervention']","['ED and MD risk factors', 'acceptability and efficacy', 'DB condition']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2732632', 'cui_str': 'Dissatisfaction with body image'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1737329', 'cui_str': 'Dysmorphism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1737329', 'cui_str': 'Dysmorphism'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1737329', 'cui_str': 'Dysmorphism'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0393551,"Results at post-intervention were not significant, with the exception that body appreciation showed significantly greater improvements in the DB condition (post-intervention: p < .01, between-condition Cohen's d = 0.40; 4-week: p < .001, between-condition Cohen's d = 0.80; and 24-week follow-up: p < .001, between-condition Cohen's d = 0.58).
","[{'ForeName': 'Maurício', 'Initials': 'M', 'LastName': 'Almeida', 'Affiliation': 'NICTA, Body Image and Eating Disorder Research Group, Federal University of Juiz de Fora, Governador Valadares, Brazil.'}, {'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, University of California San Diego, San Diego, California, USA.'}, {'ForeName': 'Priscila Figueiredo', 'Initials': 'PF', 'LastName': 'Campos', 'Affiliation': 'NICTA, Body Image and Eating Disorder Research Group, Federal University of Juiz de Fora, Governador Valadares, Brazil.'}, {'ForeName': 'Ana Carolina Soares', 'Initials': 'ACS', 'LastName': 'Amaral', 'Affiliation': 'Federal Institute of Education, Science and Technology of Southeast of Minas Gerais - Campus Barbacena, Barbacena, Brazil.'}, {'ForeName': 'Pedro Henrique Berbert', 'Initials': 'PHB', 'LastName': 'de Carvalho', 'Affiliation': 'NICTA, Body Image and Eating Disorder Research Group, Federal University of Juiz de Fora, Governador Valadares, Brazil.'}]",The International journal of eating disorders,['10.1002/eat.23423']
2744,33275804,Cognitive Training with Modern Board and Card Games in Healthy Older Adults: Two Randomized Controlled Trials.,"OBJECTIVES
The aim of this study was to assess the effectiveness of a cognitive intervention based on modern board and card games.
METHODS
We conducted two two-arm parallel-group, randomized controlled trials. The first one (pilot study) was non-blind. The second one (main study) was a double-blind design. Participants (14 in a pilot study and 35 in the main study) were healthy older adults over 65 years old who were assisting to adult care institutions. In the pilot study, participants in the experimental group (n=6) played modern board and card games which activated cognitive processes; whereas the control group (n=6) was in the wait-list condition. In the main study, participants in the experimental group (n=12) also played modern board and card games; whereas the control group (n=15) performed standardized paper-and-pencil cognitive tasks. Psychologists specialized in older-people conducted all the interventions. In both studies, intervention sessions were bi-weekly for 5 weeks. The outcomes of both studies were cognitive status and executive functioning, depressive symptomatology, and quality of life measures. All assessment and intervention sessions took place in their habitual centers.
RESULTS
In the pilot study, participants in the games intervention showed a significant improvement in semantic verbal fluency. In the main study, both interventions showed significant improvements in phonemic verbal fluency. Whilst board and card games maintained motor impulsivity control, paper-and-pencil tasks improved speed in an inhibition task.
CONCLUSIONS
Modern board and card games could be an effective cognitive intervention to maintain some cognitive functions. This article is protected by copyright. All rights reserved.",2020,"Whilst board and card games maintained motor impulsivity control, paper-and-pencil tasks improved speed in an inhibition task.
","['Healthy Older Adults', 'Participants (14 in a pilot study and 35 in the main study) were healthy older adults over 65 years old who were assisting to adult care institutions', 'participants in the experimental group (n=12) also played modern board and card games; whereas the control group (n=15) performed', 'participants in the experimental group (n=6']","['Cognitive Training with Modern Board and Card Games', 'cognitive intervention based on modern board and card games', 'standardized paper-and-pencil cognitive tasks', 'played modern board and card games which activated cognitive processes']","['cognitive status and executive functioning, depressive symptomatology, and quality of life measures', 'semantic verbal fluency', 'phonemic verbal fluency']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C1171177', 'cui_str': 'Adult care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}]",,0.0384399,"Whilst board and card games maintained motor impulsivity control, paper-and-pencil tasks improved speed in an inhibition task.
","[{'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Estrada-Plana', 'Affiliation': 'University of Lleida, Department of Psychology, Lleida, Spain.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Montanera', 'Affiliation': 'University of Lleida, Department of Psychology, Lleida, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ibarz-Estruga', 'Affiliation': 'Residencia Comtes Urgell, Balaguer, Spain.'}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'March-Llanes', 'Affiliation': 'University of Lleida, Department of Psychology, Lleida, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Vita-Barrull', 'Affiliation': 'University of Lleida, Department of Psychology, Lleida, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Guzmán', 'Affiliation': 'Afim21; Almeria, Spain.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Ros-Morente', 'Affiliation': 'University of Lleida, Department of Psychology, Lleida, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Ayesa', 'Affiliation': 'Valdecilla Biomedical Research Center, Santander, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moya-Higueras', 'Affiliation': 'University of Lleida, Department of Psychology, Lleida, Spain.'}]",International journal of geriatric psychiatry,['10.1002/gps.5484']
2745,33278599,"A randomized phase III trial comparing adjuvant single-agent S1, S-1 with oxaliplatin, and postoperative chemoradiation with S-1 and oxaliplatin in patients with node-positive gastric cancer after D2 resection: the ARTIST 2 trial.","BACKGROUND
Adjuvant chemotherapy and/or chemoradiotherapy are some of the standards of care for gastric cancer (GC). The Adjuvant chemoRadioTherapy In Stomach Tumors (ARTIST) 2 trial compares two adjuvant chemotherapy regimens and chemoradiotherapy in patients with D2-resected, stage II or III, node-positive gastric cancer.
PATIENTS AND METHODS
The ARTIST 2 compared, in a 1:1:1 ratio, three adjuvant regimens: oral S-1 (40-60 mg twice daily 4-weeks-on/2-weeks-off) for one year, S-1 (2-weeks-on/1-week-off) plus oxaliplatin 130 mg/m 2 every 3 weeks (SOX) for six months, and SOX plus chemoradiotherapy 45 Gy (SOXRT). Randomization was stratified according surgery type (total or subtotal gastrectomy), pathologic stage (II or III), and Lauren histologic classification (diffuse or intestinal/mixed). The primary endpoint was disease-free survival (DFS) at 3-years; a reduction of 33% in the hazard ratio (HR) for DFS with SOX or SOXRT, when compared to S-1, was considered clinically meaningful. The trial is registered at clinicaltrials.gov (NCT0176146).
RESULTS
A total of 546 patients were recruited between February 2013 and January 2018 with 182, 181, and 183 patients in the S-1, SOX, and SOXRT arms, respectively. Median follow-up period was 47 months, with 178 DFS events observed. Estimated 3-year DFS rates were 64.8%, 74.3%, and 72.8% in the S-1, SOX, and SOXRT arms, respectively. HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 vs. SOX, 0.692 (P=0.042) and S-1 vs. SOXRT, 0.724 (P=0.074). No difference in DFS was found between SOX and SOXRT (HR 0.971, P=0.879). Adverse events were as anticipated in each arm, and were generally well-tolerated and manageable.
CONCLUSION
In patients with curatively D2-resected, stage II/III, node-positive GC, adjuvant SOX, or SOX/RT was effective in prolonging DFS, when compared to S-1 monotherapy. The addition of radiotherapy to SOX did not significantly reduce the rate of recurrence after D2-gastrectomy.",2020,"HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 vs. SOX, 0.692","['patients with node-positive gastric cancer after D2 resection', 'patients with D2-resected, stage II or III, node-positive gastric cancer', 'Stomach Tumors', 'A total of 546 patients were recruited between February 2013 and January 2018 with 182, 181, and 183 patients in the S-1, SOX, and SOXRT arms, respectively']","['SOX plus chemoradiotherapy 45 Gy (SOXRT', 'oral S-1', 'oxaliplatin', 'Adjuvant chemoRadioTherapy', 'Adjuvant chemotherapy', 'adjuvant chemotherapy regimens and chemoradiotherapy', 'adjuvant single-agent S1, S-1 with oxaliplatin, and postoperative chemoradiation with S-1 and oxaliplatin']","['rate of recurrence', 'DFS', 'Estimated 3-year DFS rates', 'Adverse events', 'disease-free survival (DFS', 'tolerated and manageable', 'HR for DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0038356', 'cui_str': 'Neoplasm of stomach'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Chemoradiotherapy'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",546.0,0.200634,"HR for DFS in the control arm (S-1) was shorter than that in the SOX and SOXRT arms: S-1 vs. SOX, 0.692","[{'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Lim', 'Affiliation': 'Radiation Oncology.'}, {'ForeName': 'Tae Sung', 'Initials': 'TS', 'LastName': 'Sohn', 'Affiliation': 'Surgery.'}, {'ForeName': 'Jeeyun', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Zang', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Gyeonggi-do, Korea.'}, {'ForeName': 'Seung Tae', 'Initials': 'ST', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine.'}, {'ForeName': 'Jung Hoon', 'Initials': 'JH', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University School of Medicine, Jinju, Korea.'}, {'ForeName': 'Sung Yong', 'Initials': 'SY', 'LastName': 'Oh', 'Affiliation': 'Department of Hematology-Oncology, Dong-A University, Busan, Korea.'}, {'ForeName': 'In Gyu', 'Initials': 'IG', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Ji', 'Affiliation': 'Department of Internal Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.'}, {'ForeName': 'Dong Bok', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Jeong Il', 'Initials': 'JI', 'LastName': 'Yu', 'Affiliation': 'Radiation Oncology.'}, {'ForeName': 'Kyoung-Mee', 'Initials': 'KM', 'LastName': 'Kim', 'Affiliation': 'Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Surgery.'}, {'ForeName': 'Min Gew', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Surgery.'}, {'ForeName': 'Jun Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Surgery.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Surgery.'}, {'ForeName': 'Jung Yong', 'Initials': 'JY', 'LastName': 'Hong', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine.'}, {'ForeName': 'Joon Oh', 'Initials': 'JO', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine.'}, {'ForeName': 'Jae Moon', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': 'Surgery. Electronic address: jmoon.bae@samsung.com.'}, {'ForeName': 'Won Ki', 'Initials': 'WK', 'LastName': 'Kang', 'Affiliation': 'Division of Hematology-Oncology, Departments of Medicine. Electronic address: wkkang@skku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.11.017']
2746,33278591,Timing Matters: Transcranial Direct Current Stimulation After Extinction Learning Impairs Subsequent Fear Extinction Retention.,"BACKGROUND
Transcranial direct current stimulation (tDCS) has previously been shown to improve fear extinction learning and retention when administered prior to or during extinction learning. This study investigates whether tDCS immediately following extinction learning improves efficacy of extinction memory retention.
METHODS
30 participants completed a 2-day fear learning and extinction paradigm, where they acquired fear of a stimulus conditioned to an aversive electric shock on day 1. Extinction learning occurred on day 1, with tDCS or sham tDCS administered immediately following the learning phase. Participants returned for a second day test of extinction memory recall. Skin conductance was measured as the primary outcome.
RESULTS
/Conclusions Participants in the tDCS group showed impaired fear extinction retention on day 2, marked by significant generalisation of fear to the safety stimulus. This contrasts with earlier studies showing improved extinction retention when stimulation occurred during encoding of extinction learning, compared to immediate consolidation as in our study. These findings may have important implications for the use of tDCS during exposure therapy for anxiety and trauma disorders.",2020,"Participants in the tDCS group showed impaired fear extinction retention on day 2, marked by significant generalisation of fear to the safety stimulus.","['30 participants completed a', 'Timing Matters']","['tDCS', 'Transcranial direct current stimulation (tDCS', 'tDCS or sham tDCS', 'Transcranial Direct Current Stimulation', '2-day fear learning and extinction paradigm', 'extinction learning']","['Fear Extinction Retention', 'generalisation of fear to the safety stimulus', 'Skin conductance', 'fear extinction retention', 'extinction retention', 'Extinction learning']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449243', 'cui_str': 'Timing'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",30.0,0.0356996,"Participants in the tDCS group showed impaired fear extinction retention on day 2, marked by significant generalisation of fear to the safety stimulus.","[{'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Ney', 'Affiliation': 'School of Psychology, University of Tasmania, Australia. Electronic address: luke.ney@utas.edu.au.'}, {'ForeName': 'Carmelo M', 'Initials': 'CM', 'LastName': 'Vicario', 'Affiliation': 'University of Messina, Department of Scienze Cognitive Della Formazione e Degli Studi Culturali, Messina, Italy. Electronic address: cvicario@unime.it.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Deptartment of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund; Department of Neurology, University Medical Hospital Bergmannsheil, Bochum, Germany.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Felmingham', 'Affiliation': 'School of Psychological Sciences, University of Melbourne, Australia.'}]",Neurobiology of learning and memory,['10.1016/j.nlm.2020.107356']
2747,33278521,Airway Insertion First Pass Success and Patient Outcomes in Adult Out-of-Hospital Cardiac Arrest: The Pragmatic Airway Resuscitation Trial.,"OBJECTIVE
While emphasized in clinical practice, the association between advanced airway insertion first-pass success (FPS) and patient outcomes is incompletely understood. We sought to determine the association of airway insertion FPS with adult out-of-hospital cardiac arrest (OHCA) outcomes in the Pragmatic Airway Resuscitation Trial (PART).
METHODS
We performed a secondary analysis of PART, a multicenter clinical trial comparing LT and ETI upon adult OHCA outcomes. We defined FPS as successful LT insertion or ETI on the first attempt as reported by EMS personnel. We examined the outcomes return of spontaneous circulation (ROSC), 72 -h survival, hospital survival, and hospital survival with favorable neurologic status (Modified Rankin Scale ≤3). Using multivariable GEE (generalized estimating equations), we determined the association between FPS and OHCA outcomes, adjusting for age, sex, witnessed arrest, bystander CPR, initial rhythm, and initial airway type.
RESULTS
Of 3,004 patients enrolled in the trial, 1,423 received LT, 1,227 received ETI, 354 received bag-valve-mask ventilation only. FPS was: LT 86.2% and ETI 46.7%. FPS was associated with increased ROSC (aOR 1.23; 95%CI: 1.07-1.41)), but not 72 -h survival (1.22; 0.94-1.58), hospital survival (0.90; 0.68-1.19) or hospital survival with favorable neurologic status (0.66; 0.37-1.19).
CONCLUSION
In adult OHCA, airway insertion FPS was associated with increased ROSC but not other OHCA outcomes. The influence of airway insertion FPS upon OHCA outcomes is unclear.",2020,"FPS was associated with increased ROSC (aOR 1.23; 95%CI: 1.07-1.41)), but not 72 -h survival (1.22; 0.94-1.58), hospital survival (0.90; 0.68-1.19) or hospital survival with favorable neurologic status (0.66; 0.37-1.19).
","['3,004 patients enrolled in the trial, 1,423 received LT, 1,227 received ETI, 354 received', 'Adult Out-of-Hospital Cardiac Arrest']","['airway insertion FPS with adult out-of-hospital cardiac arrest (OHCA', 'bag-valve-mask ventilation only', 'OHCA']","['outcomes return of spontaneous circulation (ROSC), 72\u2009-h survival, hospital survival, and hospital survival with favorable neurologic status (Modified Rankin Scale ≤3', 'ROSC', 'FPS and OHCA outcomes, adjusting for age, sex, witnessed arrest, bystander CPR, initial rhythm, and initial airway type', 'hospital survival', 'hospital survival with favorable neurologic status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}]","[{'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1960845', 'cui_str': 'Bag valve mask ventilation'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0444693', 'cui_str': 'First pass'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",3004.0,0.0975185,"FPS was associated with increased ROSC (aOR 1.23; 95%CI: 1.07-1.41)), but not 72 -h survival (1.22; 0.94-1.58), hospital survival (0.90; 0.68-1.19) or hospital survival with favorable neurologic status (0.66; 0.37-1.19).
","[{'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Lesnick', 'Affiliation': 'Department of Emergency Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Justin X', 'Initials': 'JX', 'LastName': 'Moore', 'Affiliation': 'Division of Epidemiology, Department of Population Health Sciences, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Yefei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Williamson County Emergency Medical Services, Georgetown, TX, USA; Texas A&M Health Science Center, Temple, TX, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'Clinical Trials Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Department of Emergency Medicine, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'Ahamed H', 'Initials': 'AH', 'LastName': 'Idris', 'Affiliation': 'Department of Emergency Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Klug', 'Affiliation': 'Legacy Meridian Park Medical Center. Tualatin, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dennis', 'Affiliation': 'Tualatin Valley Fire & Rescue, Tigard, OR, USA.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA; Department of Emergency Medicine, Saint Vincent Hospital, Allegheny Health Network, Erie, PA, USA.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Doshi', 'Affiliation': 'Department of Emergency Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: henry.e.wang@uth.tmc.edu.'}]",Resuscitation,['10.1016/j.resuscitation.2020.11.030']
2748,33278503,Low-dose Whole-lung Irradiation for COVID-19 Pneumonia: Final Results of a Pilot Study.,"INTRODUCTION
Radiotherapy (RT) -commonly employed in cancer management- has been considered as one of the potential treatments for COVID-19 pneumonia. Here, we present the results of the pilot trial evaluating low-dose whole-lung irradiation (LD-WLI) in patients with COVID-19 pneumonia.
METHODS
Ten patients with moderate COVID-19 pneumonia were treated with LD-WLI in a single fraction of 0.5 or 1.0 Gy along with the national protocol. The primary endpoint was the improvement in SpO 2 . The secondary endpoints were the number of hospital/ICU stay days, the number of intubations after RT, 28-day mortality, and changes in biomarkers. The response rate (RR) was defined as a rise in SpO 2 upon RT with a rising or constant trend in the next 2 days, clinical recovery (CR) included patients who were discharged or acquired SpO 2 ≥93% on room air, and 28-day mortality rate was defined based on RT day.
RESULTS
The median age was 75 years (80% male). Five, 1, and 4 patients received single 0.5Gy, two 0.5Gy, and single 1.0Gy LD-WLI, respectively. The mean improvement in SpO 2 at days 1 and 2 after RT was 2.4% (±4.8%) and 3.6% (±6.1%), respectively, with improvement in 9 patients after 1 day. Five, 1, and 4 patients were discharged, opted out the trial, and died in hospital, respectively. Two of 5 discharged patients died within 3 days at home. Among discharged patients, the SpO 2 at discharge was 81-88% in 3 and 93% in the other 2 patients. Overall, the RR and CR were 63.6% and 55.5%, respectively. The RR, CR, and 28-day mortality of single 0.5Gy- and 1.0Gy-WLI were 71.4 vs. 50% (p = 0.57), 60 vs. 50% (p = 0.64), and 50 vs. 75% (p = 0.57), respectively.
CONCLUSION
LD-WLI with a single 0.5 Gy or 1 Gy-fraction is feasible. A randomized trial with patients that do not receive radiation is required to assess efficacy of LD-WLI for COVID-19.",2020,"The mean improvement in SpO 2 at days 1 and 2 after RT was 2.4% (±4.8%) and 3.6% (±6.1%), respectively, with improvement in 9 patients after 1 day.","['Ten patients with moderate COVID-19 pneumonia were treated with LD-WLI in a single fraction of 0.5 or 1.0 Gy along with the national protocol', 'COVID-19 Pneumonia', 'The median age was 75 years (80% male', 'patients with COVID-19 pneumonia']","['low-dose whole-lung irradiation (LD-WLI', 'Low-dose Whole-lung Irradiation']","['RR and CR', 'RR, CR, and 28-day mortality of single 0.5Gy- and 1.0Gy-WLI', '28-day mortality rate', 'SpO 2 at discharge', 'response rate (RR', 'number of hospital/ICU stay days, the number of intubations after RT, 28-day mortality, and changes in biomarkers', 'improvement in SpO 2 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",10.0,0.20523,"The mean improvement in SpO 2 at days 1 and 2 after RT was 2.4% (±4.8%) and 3.6% (±6.1%), respectively, with improvement in 9 patients after 1 day.","[{'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Ameri', 'Affiliation': 'Associate Professor of Clinical Oncology, Department of Clinical Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Pooya', 'Initials': 'P', 'LastName': 'Ameri', 'Affiliation': 'Medical student, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Rahnama', 'Affiliation': 'Department of Clinical Oncology, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mokhtari', 'Affiliation': 'Associate Professor of Pulmonary and Critical Care Medicine, Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Meghdad', 'Initials': 'M', 'LastName': 'Sedaghat', 'Affiliation': 'Assistant Professor of Internal Medicine, Department of Internal Medicine, Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Hadavand', 'Affiliation': 'Assistant Professor, Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Bozorgmehr', 'Affiliation': 'Assistant Professor of Pulmonology, Clinical Research Development Unit, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Assistant Professor, Infectious Diseases and Tropical Medicine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Taghizadeh-Hesary', 'Affiliation': 'Department of Clinical Oncology, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: f_taghizadeh@sbmu.ac.ir.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.11.065']
2749,33278364,The effect of a novel perturbation-based pinch task training on sensorimotor performance of upper extremity for chronic stroke patients: a pilot randomized control trial.,"OBJECTIVE
To investigate the effects of perturbation-based pinch task training on the sensorimotor performance of the upper extremities of chronic stroke patients via a novel vibrotactile therapy system.
DESIGN
A single-blinded randomized controlled trial.
SETTING
A university hospital.
PARTICIPANTS
Nineteen chronic stroke patients randomly assigned into either an experimental group or a control group completed the study.
INTERVENTIONS
In addition to10 minutes of traditional sensorimotor facilitation, each participant in the experimental group received 20 minutes of perturbation-based pinch task training in each treatment session, and the controls received 20 minutes of task-specific motor training twice a week for six weeks.
MAIN OUTCOME MEASURES
The scores for the primary outcome: Semmes-Weinstein monofilament (SWM) and those for the secondary outcomes: Fugl-Meyer motor assessment (FMA), amount of use (AOU), quality of movement (QOM) on the Motor Activity Log (MAL) scale, and Box and Block Test (BBT) were recorded. All outcome measures were recorded at pre-treatment, post-treatment, and at the 12-week follow-up.
RESULTS
There were statistically significant between-group differences in the training-induced improvements revealed in the SWM results (p = 0.04) immediately following training and in the BBT results (p = 0.05) at the 12-week follow-up. The changes in muscle tone and in the QOM, SWM, and BBT scores indicated statistically significant improvements after 12 sessions of treatment for the experimental group. For the control group, a significant statistical improvement was found in the wrist (p = 0.00) and coordination (p = 0.01) component of the FMA score.
CONCLUSIONS
This study indicated that the perturbation-based pinch task training has beneficial effects on sensory restoration of the affected thumb in chronic stroke patients.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, identifier NCT03798340; date of registration: January 9, 2019 (retrospectively registered). https://clinicaltrials.gov/ct2/show/NCT03798340.",2020,"For the control group, a significant statistical improvement was found in the wrist (p = 0.00) and coordination (p = 0.01) component of the FMA score.
","['Nineteen chronic stroke patients', 'chronic stroke patients', 'A university hospital', 'chronic stroke patients via a novel vibrotactile therapy system']","['20 minutes of perturbation-based pinch task training', 'perturbation-based pinch task training', 'novel perturbation-based pinch task training']","['Weinstein monofilament (SWM) and those for the secondary outcomes: Fugl-Meyer motor assessment (FMA), amount of use (AOU), quality of movement (QOM) on the Motor Activity Log (MAL) scale, and Box and Block Test (BBT', 'muscle tone and in the QOM, SWM, and BBT scores', 'SWM results', 'FMA score']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}]",,0.0496835,"For the control group, a significant statistical improvement was found in the wrist (p = 0.00) and coordination (p = 0.01) component of the FMA score.
","[{'ForeName': 'Hsiu-Yun', 'Initials': 'HY', 'LastName': 'Hsu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, TAIWAN; Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Tainan, TAIWAN.'}, {'ForeName': 'Ta-Shen', 'Initials': 'TS', 'LastName': 'Kuan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, TAIWAN.'}, {'ForeName': 'Ching-Liang', 'Initials': 'CL', 'LastName': 'Tsai', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, TAIWAN.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopedics, College of Medicine, National Cheng Kung University, Tainan, TAIWAN.'}, {'ForeName': 'Yao-Lung', 'Initials': 'YL', 'LastName': 'Kuo', 'Affiliation': 'Department of Surgery, College of Medicine, National Cheng Kung University, College of Medicine.'}, {'ForeName': 'Fong-Chin', 'Initials': 'FC', 'LastName': 'Su', 'Affiliation': 'Department of Biomedical Engineering, College of Engineering, National Cheng Kung University, Tainan, TAIWAN; Medical Device Innovation Center, National Cheng Kung University, Tainan, TAIWAN. Electronic address: fcsu@mail.ncku.edu.tw.'}, {'ForeName': 'Li-Chieh', 'Initials': 'LC', 'LastName': 'Kuo', 'Affiliation': 'Department of Occupational Therapy, College of Medicine, National Cheng Kung University, Tainan, TAIWAN; Medical Device Innovation Center, National Cheng Kung University, Tainan, TAIWAN. Electronic address: jkkuo@mail.ncku.edu.tw.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.11.004']
2750,33278332,Pharmacokinetics of Sugammadex Dosed by Actual and Ideal Body Weight in Patients with Morbid Obesity Undergoing Surgery.,"This analysis of a published study (NCT03346070) evaluated the pharmacokinetics (PK) of sugammadex dosed by actual (ABW) or ideal body weight (IBW) for reversal of moderate or deep neuromuscular block (M-/D-NMB) in adults with morbid obesity. Adults with BMI ≥40 kg/m 2 , ABW ≥100 kg, and ASA Class 3 were stratified by NMB agent (rocuronium or vecuronium) and randomized 1:1:1:1:1 to 1) M-NMB, sugammadex 2 mg/kg ABW; 2) M-NMB, sugammadex 2 mg/kg IBW; 3) M-NMB, neostigmine 5 mg + glycopyrrolate 1 mg; 4) D-NMB, sugammadex 4 mg/kg ABW; 5) D-NMB, sugammadex 4 mg/kg IBW. Plasma samples for sugammadex quantification were collected predose, 2, 5, 15, 60 and 120 minutes and 4, 6 hours post-dose. Natural log PK parameters were analyzed using linear fixed effect model with treatment, mode (ABW, IBW), and mode by treatment interaction as fixed terms. The sugammadex PK profile showed rapid distribution followed by monophasic decline consistent with a 2-compartment model examined by dose and mode. Absolute sugammadex exposures were approximately 50% higher in the ABW vs. IBW group; dose-independent parameters (CL and Vd) and t1/2 remained constant. Sugammadex PK parameter values increased in dose-dependent, linear manner following dosing by ABW or IBW such that PK continues to be predictive across the clinical dose range. In conjunction with previously published results showing faster recovery with ABW vs. IBW dosing across NMBA and depth of NMB, these PK findings continue to support dosing by ABW in patients with morbid obesity irrespective of depth of NMB.",2020,"Sugammadex PK parameter values increased in dose-dependent, linear manner following dosing by ABW or IBW such that PK continues to be predictive across the clinical dose range.","['patients with morbid obesity irrespective of depth of NMB', 'adults with morbid obesity', 'Patients with Morbid Obesity Undergoing Surgery', 'Adults with BMI ≥40 kg/m 2 , ABW ≥100 kg, and ASA Class 3 were stratified by']","['M-NMB, neostigmine 5 mg + glycopyrrolate 1 mg; 4) D-NMB, sugammadex 4 mg/kg ABW; 5) D-NMB, sugammadex 4 mg/kg IBW', 'sugammadex dosed by actual (ABW) or ideal body weight (IBW', 'Sugammadex Dosed by Actual and Ideal Body Weight', 'NMB agent (rocuronium or vecuronium']","['Sugammadex PK parameter values', 'Natural log PK parameters', 'Absolute sugammadex exposures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0068601', 'cui_str': 'neuromedin B'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282379', 'cui_str': 'Aruba'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}]","[{'cui': 'C0068601', 'cui_str': 'neuromedin B'}, {'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0986341', 'cui_str': 'Glycopyrrolate 1 MG'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0282379', 'cui_str': 'Aruba'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0421272', 'cui_str': 'Ideal body weight'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0209337', 'cui_str': 'Rocuronium'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0549193', 'cui_str': 'Parameter'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.084372,"Sugammadex PK parameter values increased in dose-dependent, linear manner following dosing by ABW or IBW such that PK continues to be predictive across the clinical dose range.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mostoller', 'Affiliation': 'Department of Clinical Research, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wrishko', 'Affiliation': 'Department of Pharmacokinetics Pharmacodynamics and Drug Metabolism, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Lata', 'Initials': 'L', 'LastName': 'Maganti', 'Affiliation': 'Department of Biostatistics, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'W Joseph', 'Initials': 'WJ', 'LastName': 'Herring', 'Affiliation': 'Department of Clinical Research, Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Mariëlle', 'Initials': 'M', 'LastName': 'van Zutphen-van Geffen', 'Affiliation': 'Certara Strategic Consulting, Oss, The Netherlands.'}]",Clinical and translational science,['10.1111/cts.12941']
2751,33278292,Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: A Randomized Controlled Trial.,"OBJECTIVE
To evaluate whether high-frequency transcutaneous electrical nerve stimulation (hfTENS) reduces pain during medication abortion.
METHODS
We conducted a randomized, placebo-controlled trial. Participants who were undergoing medication abortion with mifepristone and misoprostol through 70 days of gestation either received active 80 Hz hfTENS or sham to use for a minimum of 60 minutes within 8 hours of misoprostol. Maximum pain on an 11-point numerical rating scale at 8 hours after misoprostol was the primary outcome. We estimated 20 per group for 80% power to detect a 2-point difference and up to 10% attrition. Secondary outcomes included a maximum pain score at 24 hours, additional analgesia use, the difference in score before and after treatment, the experience of side effects, abortion outcomes, and acceptability. We collected data at baseline, time of misoprostol (0-hour), 8-hour and 24 hours using real-time electronic surveys, and at follow-up.
RESULTS
Between June 2019 and March 2020, we screened 251 patients and randomized 40-20 each to hfTENS or sham-with one postrandomization exclusion and two patients lost to follow-up. Baseline characteristics were similar. Median maximum pain scores at 8 hours were 7.0 (interquartile range 3.0) and 10.0 (interquartile range 3.0) for hfTENS and sham, respectively. The distribution of these scores was lower among hfTENS users compared with sham (mean rank 15.17 vs 22.63, P=.036). High-frequency TENS users also experienced a significant reduction in posttreatment pain score (-2.0 [interquartile range 2.5] vs 0 [interquartile range 1.5], P=.008). We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability.
CONCLUSION
High-frequency TENS reduced maximum pain scores within 8 hours of misoprostol and reduced pain scores immediately after treatment compared with placebo. High-frequency TENS offers an effective nonpharmacologic option for pain management during medication abortion.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03925129.",2020,"We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability.
","['With Medication Abortion', 'Between June 2019 and March 2020, we screened 251 patients and randomized 40-20 each to', 'through 70 days of gestation either received', 'Participants who were undergoing medication abortion with']","['high-frequency transcutaneous electrical nerve stimulation (hfTENS', 'placebo', 'misoprostol', 'hfTENS or sham-with one postrandomization exclusion', 'mifepristone and misoprostol', 'Transcutaneous Electrical Nerve Stimulation', 'active 80 Hz hfTENS or sham']","['Maximum pain', 'posttreatment pain score', 'Median maximum pain scores', 'additional analgesia, distribution of maximum pain scores', 'maximum pain score at 24 hours, additional analgesia use, the difference in score before and after treatment, the experience of side effects, abortion outcomes, and acceptability', '11-point numerical rating scale', 'Pain', 'maximum pain scores', 'pain scores', 'side effects, or measures of acceptability']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1457900', 'cui_str': 'Each'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1291733', 'cui_str': 'Posttreatment pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",251.0,0.75782,"We found no statistically significant differences in use of additional analgesia, distribution of maximum pain scores at 24 hours, side effects, or measures of acceptability.
","[{'ForeName': 'Ariella R', 'Initials': 'AR', 'LastName': 'Goldman', 'Affiliation': 'Icahn School of Medicine at Mount Sinai and Planned Parenthood of Greater New York, New York, New York.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Porsch', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Hintermeister', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Dragoman', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004208']
2752,33278291,Preoperative Pelvic Floor Injections With Bupivacaine and Dexamethasone for Pain Control After Vaginal Prolapse Repair: A Randomized Controlled Trial.,"OBJECTIVE
To test the hypothesis that preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone would decrease postoperative pain after vaginal native tissue prolapse repairs, compared with saline and bupivacaine.
METHODS
We conducted a three-arm, double-blind, randomized trial of bilateral transobturator levator ani muscle injections and transvaginal pudendal nerve blocks before vaginal reconstructive and obliterative prolapse procedures (uterosacral ligament suspension, sacrospinous ligament fixation, levator myorrhaphy, or colpocleisis). Women were randomized to one of three study medication groups: 0.9% saline, 0.25% bupivacaine, or combination 0.25% bupivacaine with 4 mg dexamethasone. Our primary outcome was a numeric rating scale pain score on postoperative day 1. Using an analysis of variance evaluated at the two-sided 0.05 significance level, an assumed variance of the means of 0.67, and SD of 1.75, we calculated 21 women per arm to detect a 2-point change on the numeric rating scale (90% power), which we increased to 25 per arm to account for 20% attrition and the use of nonparametric statistical methods.
RESULTS
From June 2017 through April 2019, 281 women were screened and 75 (26.7%) were randomized with no differences in baseline demographics among study arms. There was no significant difference in median pain scores on postoperative day 1 among study groups (median [interquartile range] pain score 4.0 [2.0-7.0] for placebo vs 4.0 [2.0-5.5] for bupivacaine vs 4.0 [1.5-5.0] for bupivacaine with dexamethasone, P=.92).
CONCLUSION
Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone did not improve postoperative pain after vaginal native tissue prolapse procedures.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03040011.",2020,"There was no significant difference in median pain scores on postoperative day 1 among study groups (median [interquartile range] pain score 4.0 [2.0-7.0] for placebo vs 4.0 [2.0-5.5] for bupivacaine vs 4.0 [1.5-5.0] for bupivacaine with dexamethasone, P=.92).
","['after vaginal native tissue prolapse repairs', 'after vaginal native tissue prolapse procedures', 'After Vaginal Prolapse Repair', 'From June 2017 through April 2019, 281 women were screened and 75 (26.7']","['saline and bupivacaine', 'placebo', 'bupivacaine', 'saline, 0.25% bupivacaine, or combination 0.25% bupivacaine with 4 mg dexamethasone', 'bilateral transobturator levator ani muscle injections and transvaginal pudendal nerve blocks before vaginal reconstructive and obliterative prolapse procedures (uterosacral ligament suspension, sacrospinous ligament fixation, levator myorrhaphy, or colpocleisis', 'bupivacaine and dexamethasone', 'Bupivacaine and Dexamethasone']","['Pain Control', 'median pain scores', 'postoperative pain', 'pain score', 'numeric rating scale pain score', 'numeric rating scale']","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2938890', 'cui_str': 'Vaginal prolapse repair'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0224384', 'cui_str': 'Structure of levator ani muscle'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach'}, {'cui': 'C0394776', 'cui_str': 'Injection of anesthetic agent into pudendal nerve'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0439676', 'cui_str': 'Obliterative'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0230306', 'cui_str': 'Structure of uterosacral ligament'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0225049', 'cui_str': 'Structure of sacrospinous ligament'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0027094', 'cui_str': 'Suture of muscle'}, {'cui': 'C0195191', 'cui_str': 'Complete colpocleisis'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",281.0,0.615901,"There was no significant difference in median pain scores on postoperative day 1 among study groups (median [interquartile range] pain score 4.0 [2.0-7.0] for placebo vs 4.0 [2.0-5.5] for bupivacaine vs 4.0 [1.5-5.0] for bupivacaine with dexamethasone, P=.92).
","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Giugale', 'Affiliation': 'Division of Urogynecology and Pelvic Floor Reconstructive Surgery, Magee-Womens Hospital of UPMC, the University of Pittsburgh School of Medicine, the Department of Anesthesiology, Magee-Womens Hospital of UPMC, the Department of Anesthesiology, UPMC, and the Magee-Womens Research Institute, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Baranski', 'Affiliation': ''}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Meyn', 'Affiliation': ''}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Schott', 'Affiliation': ''}, {'ForeName': 'Trent D', 'Initials': 'TD', 'LastName': 'Emerick', 'Affiliation': ''}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Moalli', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004205']
2753,33278290,Foley Bulb Insertion by Blind Placement Compared With Direct Visualization: A Randomized Controlled Trial.,"OBJECTIVE
To test the hypothesis that digital placement of a balloon catheter is not inferior to the speculum method in terms of rate of maternal infection.
METHODS
In an open-label noninferiority randomized trial, pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced) were randomly assigned to balloon catheter that was placed either digitally or using a sterile speculum. The primary outcome was a composite of maternal infection, defined by occurrence of fever (temperature 38°C or higher), chorioamnionitis, or endometritis (diagnoses were made by the managing obstetric physician or midwife). Prespecified secondary outcomes included outcomes in the primary composite, cesarean delivery rates, and maternal and neonatal outcomes. A patient satisfaction survey was also obtained. On the basis of a noninferiority margin of 10% and an expected primary outcome frequency of 10%, a sample size of 372 women was needed (90% power to confirm noninferiority with 90% protocol adherence).
RESULTS
From February 2018 through February 2019, 372 women were randomized (185 digital placement, 187 sterile speculum). Baseline characteristics were similar between groups. The composite maternal infection rate was not different between groups (digital placement arm: 15.7% vs speculum arm: 12.8%), with an absolute difference with respect to the sterile speculum arm of 2.8% (95% CI -4.3 to 9.9%), indicating noninferiority for the prespecified margin. Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm. Maternal and neonatal adverse events were not different between groups. Irrespective of method of placement, women were equally satisfied with the explanation of the method before placement, anxiety regarding the procedure, and pain during placement. More women in the sterile speculum group would choose the digital placement method for the subsequent pregnancy (37.6% vs 25.7%; P=.02.) CONCLUSION:: Digital placement of a balloon catheter for preinduction cervical ripening is noninferior to the sterile speculum method, in terms of maternal infection. Women in the sterile speculum group more frequently required a second round of the mechanical dilator. The blind digital approach is a reasonable option for balloon placement for cervical ripening.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT03450408.",2020,"Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm.","['372 women', 'From February 2018 through February 2019, 372 women were randomized (185 digital placement, 187 sterile speculum', 'pregnant women who were undergoing induction of labor with unfavorable cervix (less than 3 cm dilated and less than 60% effaced']","['balloon catheter that was placed either digitally or using a sterile speculum', 'Foley Bulb Insertion by Blind Placement', 'Direct Visualization']","['Maternal and neonatal adverse events', 'primary composite, cesarean delivery rates, and maternal and neonatal outcomes', 'composite maternal infection rate', 'composite of maternal infection, defined by occurrence of fever (temperature 38°C or higher), chorioamnionitis, or endometritis (diagnoses were made by the managing obstetric physician or midwife']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0700124', 'cui_str': 'Ectatic'}]","[{'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0025148', 'cui_str': 'Medulla oblongata structure'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0239997', 'cui_str': 'Maternal infection'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}]",372.0,0.381179,"Secondary outcomes were not different between groups, except for a higher need for a second balloon catheter in the sterile speculum arm.","[{'ForeName': 'Maggie J', 'Initials': 'MJ', 'LastName': 'Kuhlmann', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Spencer', 'Affiliation': ''}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Garcia-Jasso', 'Affiliation': ''}, {'ForeName': 'Prapti', 'Initials': 'P', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abdelwahab', 'Affiliation': ''}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Vaughn', 'Affiliation': ''}, {'ForeName': 'Karis', 'Initials': 'K', 'LastName': 'Marshall', 'Affiliation': ''}, {'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Prasad', 'Affiliation': ''}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Soulsby-Monroy', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'Antonio F', 'Initials': 'AF', 'LastName': 'Saad', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004182']
2754,33278280,Racial Disparities in Mental Health Outcomes Among Women With Early Pregnancy Loss.,"OBJECTIVE
To explore the relationship between race and depression symptoms among participants in an early pregnancy loss clinical trial.
METHODS
We performed a planned secondary analysis of a randomized trial by comparing treatments for medical management of early pregnancy loss. We hypothesized that Black participants would have higher odds of risk for major depression (measured with the CES-D [Center for Epidemiological Studies-Depression] scale) 30 days after early pregnancy loss treatment when compared with non-Black participants. We analyzed the data as a cohort, with the primary exposure being race and secondary exposure being high adverse childhood experience scores (measured with the Adverse Childhood Experience scale). Our primary outcome was risk for major depression (score of 21 or higher on the CES-D scale) 30 days after early pregnancy loss treatment.
RESULTS
Three hundred participants diagnosed with a nonviable intrauterine pregnancy from 5 to 12 weeks of gestation were randomized as part of the original trial from May 2014 to April 2017. Of 275 respondents included in this analysis, 120 [44%] self-identified as Black and 155 [56%] self-identified as non-Black. After early pregnancy loss treatment, 65 [24%] participants were at risk for major depression. Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15-3.55). After adjustment for risk for baseline depression, adverse childhood experience score, and parity, the odds of risk for major depression 30 days after pregnancy loss treatment remained higher for Black participants when compared with non-Black participants (OR 2.02; 95% CI 1.15-3.55; adjusted OR 2.48; 95% CI 1.28-4.81).
CONCLUSION
Overall, approximately one quarter of women who experience an early pregnancy loss are at an increased risk for major depression 30 days after treatment. This risk is about twice as high for Black women compared with non-Black women. There is a need for appropriate mental health resources for women undergoing early pregnancy loss care.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov, NCT02012491.",2020,Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15-3.55).,"['medical management of early pregnancy loss', 'Black participants', 'Black women compared with non-Black women', 'Three hundred participants diagnosed with a nonviable intrauterine pregnancy from 5 to 12 weeks of gestation', 'Of 275 respondents included in this analysis, 120 [44%] self-identified as Black and 155 [56%] self-identified as non-Black', 'women undergoing early pregnancy loss care', 'Women With Early Pregnancy Loss', 'participants in an early pregnancy loss clinical trial']",[],"['adverse childhood experience score, and parity, the odds of risk for major depression 30 days after pregnancy loss treatment', 'risk for major depression', 'early pregnancy loss']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149973', 'cui_str': 'Intrauterine pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3830362', 'cui_str': 'Early Pregnancy Loss'}]",300.0,0.281452,Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15-3.55).,"[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Shorter', 'Affiliation': 'Departments of Obstetrics and Gynecology and Psychiatry, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania; and the Department of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': ''}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': ''}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': ''}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': ''}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004212']
2755,33278104,Supportive Interventions to Reduce Pain and Stress During Ophthalmic Examinations for Retinopathy of Prematurity in Premature Infants.,"BACKGROUND
Ophthalmic examinations are a frequent source of pain and stress in premature infants. There is evidence for the use of supportive interventions during infant ophthalmic examinations to reduce pain and stress, but there are no standard recommendations for their implementation.
PURPOSE
The purpose of this quality improvement project was to implement evidence-based, supportive interventions during ophthalmic examinations in premature infants and evaluate the impact on pain, oxygen saturation, heart rate, bradycardic events, and neonatal stress cues.
METHODS
A preintervention and intervention group design was used. Primary outcomes were pain and oxygen saturation. Secondary outcomes were heart rate, number of bradycardic events, and number of neonatal stress cues. Independent-sample t tests were used to compare means of the measures in the preintervention and intervention groups.
RESULTS
Supportive interventions during ophthalmic examinations significantly reduced infant pain (during and after the examination), number of bradycardic events (during and after the examination), and number of neonatal stress cues (before, during, and after the examination). There was also a trend for supportive interventions to decrease pain before the examination.
IMPLICATIONS FOR PRACTICE
Supportive interventions during ophthalmic examinations are effective in reducing pain, bradycardic events, and neonatal stress cues in premature infants and can be successfully implemented as part of a unit-based protocol.
IMPLICATIONS FOR RESEARCH
Future research is needed to determine the long-term outcomes associated with supportive interventions during ophthalmic examinations in premature infants.",2020,"RESULTS
Supportive interventions during ophthalmic examinations significantly reduced infant pain (during and after the examination), number of bradycardic events (during and after the examination), and number of neonatal stress cues (before, during, and after the examination).","['premature infants', 'Premature Infants']",['Supportive Interventions'],"['heart rate, number of bradycardic events, and number of neonatal stress cues', 'number of bradycardic events', 'pain, bradycardic events, and neonatal stress cues', 'pain and stress', 'pain and oxygen saturation', 'Pain and Stress', 'infant pain', 'pain, oxygen saturation, heart rate, bradycardic events, and neonatal stress cues', 'number of neonatal stress cues', 'pain']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",,0.0576942,"RESULTS
Supportive interventions during ophthalmic examinations significantly reduced infant pain (during and after the examination), number of bradycardic events (during and after the examination), and number of neonatal stress cues (before, during, and after the examination).","[{'ForeName': 'Mikayla', 'Initials': 'M', 'LastName': 'Pollaci', 'Affiliation': ""University of Pittsburgh School of Nursing, Pennsylvania (Ms Pollaci and Drs Schlenk and Godfrey); and Behavioral Science Division, UPMC Children's Hospital of Pittsburgh, Pennsylvania (Ms Baum).""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Schlenk', 'Affiliation': ''}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Baum', 'Affiliation': ''}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Godfrey', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000803']
2756,33278856,Real-life assessment of chronic obstructive pulmonary disease patient performance with different inhalers.,"PURPOSE
This study aimed to evaluate handling of six common inhalers and to determine correlations between correct inhaler technique and patient demographics/ clinical variables.
METHODS
A total of 180 chronic obstructive pulmonary disease (COPD) patients were crossed-over to handle their past-experienced inhalers among (pMDI, Aerolizer, Handihaler, Breezhaler, Turbohaler, and Diskus) randomly, without receiving verbal or demonstrative instruction (baseline assessment). Inhaler technique was assessed using previously defined checklists. The correct use of the inhaler was then demonstrated and the patient was evaluated for inhaler use again. Demonstration was repeated until a correct technique was achieved. Number of counseling attempts needed to a complete right handling, patient demographics and clinical variables were recorded.
RESULTS
The mean percentage of total correct steps showed that pMDI is significantly lower than all other inhalers (76.01±12.61 vs 84.18±10.87, 84.60±12.10, 85.91±9.82, 90.63±9.29 and 91±10.22 for Diskus, Turbohaler, Aerolizer, Handihaler and Breezhaler respectively at p<0.001). Breezhaler showed the lowest percentage of participants with at least 1 critical error (20%) however, pMDI showed the highest percentage (85.19%) at p<0.05. Breezhaler showed the highest percentage of participants achieved a complete right handling after 1 st counseling attempt however, pMDI was the only inhaler included in a 3 rd and 4 th counseling attempts (5.93% and 0.74% respectively). Weak and very weak correlations were found between total correct steps and demographics/clinical variables CONCLUSIONS: pMDI is not preferable for handling by COPD patients. DPIs vary in ease of use, so that inhaler therapy must be individualized on basis of patient handling assessment with repeated counseling.",2020,"The mean percentage of total correct steps showed that pMDI is significantly lower than all other inhalers (76.01±12.61 vs 84.18±10.87, 84.60±12.10, 85.91±9.82, 90.63±9.29 and 91±10.22 for Diskus, Turbohaler, Aerolizer, Handihaler and Breezhaler respectively at p<0.001).","['180 chronic obstructive pulmonary disease (COPD) patients', 'chronic obstructive pulmonary disease patient performance with different inhalers']","['pMDI', 'handle their past-experienced inhalers among (pMDI, Aerolizer, Handihaler, Breezhaler, Turbohaler, and Diskus) randomly, without receiving verbal or demonstrative instruction (baseline assessment']","['complete right handling', 'mean percentage of total correct steps']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522485', 'cui_str': 'Patient performance'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}]","[{'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]",180.0,0.0773058,"The mean percentage of total correct steps showed that pMDI is significantly lower than all other inhalers (76.01±12.61 vs 84.18±10.87, 84.60±12.10, 85.91±9.82, 90.63±9.29 and 91±10.22 for Diskus, Turbohaler, Aerolizer, Handihaler and Breezhaler respectively at p<0.001).","[{'ForeName': 'Hadeer S', 'Initials': 'HS', 'LastName': 'Harb', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Nabila', 'Initials': 'N', 'LastName': 'Ibrahim Laz', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Rabea', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed E A', 'Initials': 'MEA', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}]",International journal of clinical practice,['10.1111/ijcp.13905']
2757,33278836,Frequency of awake bruxism behavior in orthodontic patients: randomized clinical trial.,"INTRODUCTION
The influence of aligners on the activity of the masticatory muscles is still controversial, especially regarding the behavior associated with awake bruxism (AB).
OBJECTIVE
To compare the frequency of AB behaviors between patients treated with aligners and fixed appliances.
METHODS
The sample comprised 38 Class I patients (mean age 22.08 years), divided by simple randomization into two groups: OA group; orthodontic aligners (n 19) and FA group; fixed appliance (n 19). The frequency of AB was investigated by the ecological momentary assessment using an online device (mentimeter), during 7 following days at different timepoints, before and after appliance placement and in the 2 nd , 3 rd , 4 th and 6 th months of orthodontic treatment. These variables were also evaluated: level of anxiety by the State-Trait Anxiety Inventory, stress by the Perceived Stress Scale, catastrophizing related to pain and degree of hypervigilance by the Pain Vigilance and Awareness Questionnaire, and the presence of facial pain evaluated by the DC/TMD.
RESULTS
There was no difference between groups in the frequency of AB behaviors, with mean of 53.5% for group OA and 51.3% for FA. The most frequent behavior was slightly touching the teeth, and in FA group there was a significant reduction in this behavior soon after appliance placement. The groups did not differ concerning the degree of anxiety, stress, catastrophizing, hypervigilance and facial pain.
CONCLUSION
The orthodontic treatment performed with aligners or fixed appliances did not influence the frequency of AB during the 6 months of treatment.",2020,"The groups did not differ concerning the degree of anxiety, stress, catastrophizing, hypervigilance and facial pain.
","['38 Class I patients (mean age 22.08 years', 'orthodontic patients', 'patients treated with aligners and fixed appliances']",['OA group; orthodontic aligners (n 19) and FA group; fixed appliance'],"['degree of anxiety, stress, catastrophizing, hypervigilance and facial pain', 'level of anxiety by the State-Trait Anxiety Inventory, stress by the Perceived Stress Scale, catastrophizing related to pain and degree of hypervigilance by the Pain Vigilance and Awareness Questionnaire, and the presence of facial pain evaluated by the DC/TMD', 'frequency of AB', 'frequency of AB behaviors']","[{'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0235013', 'cui_str': 'Hypervigilance'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0006325', 'cui_str': 'Grinding teeth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",38.0,0.0261023,"The groups did not differ concerning the degree of anxiety, stress, catastrophizing, hypervigilance and facial pain.
","[{'ForeName': 'Nayara', 'Initials': 'N', 'LastName': 'Caldas Pereira', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Paula Vanessa Pedron', 'Initials': 'PVP', 'LastName': 'Oltramari', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Paulo César Rodrigues', 'Initials': 'PCR', 'LastName': 'Conti', 'Affiliation': 'Department of Prosthodontics, Bauru School of Dentistry, University of São Paulo, Brazil.'}, {'ForeName': 'Leonardo Rigoldi', 'Initials': 'LR', 'LastName': 'Bonjardim', 'Affiliation': 'Section of Head and Face Physiology, Department of Biological Sciences, Bauru School of Dentistry, University of São Paulo, Brazil.'}, {'ForeName': 'Renata Rodrigues', 'Initials': 'RR', 'LastName': 'de Almeida-Pedrin', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Thaís Maria Freire', 'Initials': 'TMF', 'LastName': 'Fernandes', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Marcio Rodrigues', 'Initials': 'MR', 'LastName': 'de Almeida', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'de Castro Ferreira Conti', 'Affiliation': 'Department of Orthodontics, University of North Paraná (UNOPAR), Londrina-PR, Brazil.'}]",Journal of oral rehabilitation,['10.1111/joor.13130']
2758,33278754,Effect of family presence on stress response after bypass surgery.,"BACKGROUND
Coronary artery bypass grafting (CABG) is a major surgery that may cause severe surgical stress response (SR). Although the presence of family members in intensive care unit (ICU) is known to benefit intensive care patients socially and emotionally, its effects on surgical SR are unknown.
OBJECTIVES
To investigate the effect of an informed family member (IFM)'s presence in the awakening process in ICU on patients' SR after CABG.
METHODS
A nonrandomized controlled clinical study was completed with a total of 73 patients: 37 patients in the control (CG) and 36 in the intervention group (IG) underwent CABG surgery. In the CG patients, no family members were taken into the ICU during the awakening process and routine care and treatment practices were continued. In the IG patients, besides routine care and treatment practices, an IFM was taken into the ICU during the awakening process in accordance with the research method. Groups were statistically compared in terms of serum cortisol level which is the one of the main indicators of surgical SR, state anxiety, sedative drug requirements, and duration of intubation, sedation, and ICU stay. A p value <0.05 was accepted as statistically significant.
RESULTS
Presence of an IFM in the ICU was found to be effective in decreasing serum cortisol level, state anxiety, sedative drug requirements, and the duration of intubation, sedation, and ICU stay (p<0.05).
CONCLUSIONS
In CABG, the presence of IFM in ICU is effective in reducing SR.",2020,"RESULTS
Presence of an IFM in the ICU was found to be effective in decreasing serum cortisol level, state anxiety, sedative drug requirements, and the duration of intubation, sedation, and ICU stay (p<0.05).
","[""patients' SR after CABG"", '73 patients: 37 patients in the control (CG) and 36 in the intervention group (IG) underwent']","['intensive care unit (ICU', 'CABG surgery', 'Coronary artery bypass grafting (CABG']","['serum cortisol level, state anxiety, sedative drug requirements, and the duration of intubation, sedation, and ICU stay (p<0.05', 'stress response', 'surgical SR, state anxiety, sedative drug requirements, and duration of intubation, sedation, and ICU stay', 'serum cortisol level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",73.0,0.0177033,"RESULTS
Presence of an IFM in the ICU was found to be effective in decreasing serum cortisol level, state anxiety, sedative drug requirements, and the duration of intubation, sedation, and ICU stay (p<0.05).
","[{'ForeName': 'Aynur', 'Initials': 'A', 'LastName': 'Koyuncu', 'Affiliation': 'Nursing Department, Hasan Kalyoncu University, Faculty of Health Sciences, Gaziantep, Turkey. Electronic address: aynrkoyuncu@yahoo.com.tr.'}, {'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Yava', 'Affiliation': 'Nursing Department, Hasan Kalyoncu University, Faculty of Health Sciences, Gaziantep, Turkey. Electronic address: ayla.yava@hku.edu.tr.'}, {'ForeName': 'Birol', 'Initials': 'B', 'LastName': 'Yamak', 'Affiliation': 'Gaziantep Medikal Park Hospital, Gaziantep, Turkey. Electronic address: birolyamak@gmail.com.'}, {'ForeName': 'Nuri', 'Initials': 'N', 'LastName': 'Orhan', 'Affiliation': 'Gaziantep Medikal Park Hospital, Gaziantep, Turkey. Electronic address: nuriorhan@dr.com.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.11.006']
2759,33278169,"Response to: ""Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial"": Not only surgeon's manual skills...""",,2020,,['FRS) Skills Curriculum'],['Robotic Surgery'],[],"[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.195086,,"[{'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Satava', 'Affiliation': ""Department of Surgery, University of Washington Medical Center, Seattle, WA Department of Surgery, Indiana University School of Medicine, Indianapolis, IN Department of Ob/Gyn, Drexel University College of Medicine, Institute of Surgical Excellence, Philadelphia, PA Florida Hospital Nicholson Center, University of Central Florida College of Medicine, Celebration, FL Department of Surgery, Indiana University School of Medicine, Indianapolis, IN Department of Surgery, St. Mary's Hospital, Imperial College, London, United Kingdom EndoCAS Simulation Center, University of Pisa, Pisa, Italy Andersen Simulation Center, Madigan Army Medical Center, Tacoma, WA Center for Education, Simulation and Innovation, Hartford Hospital, Hartford, CT Penn Medicine Clinical Simulation Center, Philadelphia, PA Department of Colon and Rectal Surgery, Lahey Health and Medical Center, Burlington, MA National and Kapodistrian University of Athens, Athens, Greece Houston Methodist Hospital, Methodist Institute for Technology, Innovation, and Education, Houston, TX USF Health Center for Advanced Medical Learning and Simulation, Tampa, FL Lehigh Valley Health Network, Allentown PA Department of Surgery, Surgical Education and Activities Lab, Duke University Medical Center, Durham, NC Department of Surgery, St. Mary's Hospital, Imperial College, London, United Kingdom Director of Technology Enhanced Learning, ASSERT Centre, College of Medicine and Health, Brookfield Health Sciences Complex, University College Cork, Cork, Ireland.""}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Stefanidis', 'Affiliation': ''}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Levy', 'Affiliation': ''}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Martin', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Monfared', 'Affiliation': ''}, {'ForeName': 'Lava R', 'Initials': 'LR', 'LastName': 'Timsina', 'Affiliation': ''}, {'ForeName': 'Ara Wardkes', 'Initials': 'AW', 'LastName': 'Darzi', 'Affiliation': ''}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Moglia', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': ''}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Dorin', 'Affiliation': ''}, {'ForeName': 'Kristoffel R', 'Initials': 'KR', 'LastName': 'Dumon', 'Affiliation': ''}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Francone', 'Affiliation': ''}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': ''}, {'ForeName': 'Alvin C', 'Initials': 'AC', 'LastName': 'Goh', 'Affiliation': ''}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': ''}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Martino', 'Affiliation': ''}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Sudan', 'Affiliation': ''}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Vale', 'Affiliation': ''}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Gallagher', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004658']
2760,33278168,"Comment on ""Proving the Effectiveness of the Fundamentals of Robotic Surgery (FRS) Skills Curriculum: A Single-blinded, Multispecialty, Multi-institutional Randomized Control Trial"": Not Only Surgeon's Manual Skills….",,2020,,['FRS) Skills Curriculum'],['Robotic Surgery'],[],"[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],,0.15422,,"[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Valotto', 'Affiliation': 'Department of Medical Area - Urology, University Hospital of Udine, Italy Department of Medical Area - Urology, University Hospital of Udine, Italy Department of Surgery, Oncology and Gastroenterology - Urology, University of Padova, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Dal Moro', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004663']
2761,33278162,Comment on a Randomized Comparison of Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis After Esophagectomy.,,2020,,[],['Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis'],[],[],"[{'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y - action'}]",[],,0.0235397,,"[{'ForeName': 'Zeeshan', 'Initials': 'Z', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgical Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, Telangana, India.'}, {'ForeName': 'Hazarathaiah', 'Initials': 'H', 'LastName': 'Nadendla', 'Affiliation': ''}, {'ForeName': 'Manikanteswara', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004662']
2762,33238431,"Effects of a Lacto-Ovo-Vegetarian Diet on the Plasma Lipidome and Its Association with Atherosclerotic Burden in Patients with Coronary Artery Disease-A Randomized, Open-Label, Cross-over Study.","A vegetarian diet has been associated with a lower risk of coronary artery disease (CAD). Plasma triacylglycerols, ceramides, and phosphatidylcholines may improve prediction of recurrent coronary events. We sought to investigate effects of a lacto-ovo-vegetarian diet (VD) on plasma lipidome in CAD patients and simultaneously assess associations of plasma lipids with the extent of coronary atherosclerotic burden. We analyzed 214 plasma lipids within glycerolipid, sphingolipid, and sterol lipid classes using lipidomics from a randomized controlled, crossover trial comprising 31 CAD patients on standard medical therapy. Subjects completed a four-week intervention with VD and isocaloric meat diet (MD), separated by a four-week washout period. The VD increased levels of 11 triacylglycerols and lowered 7 triacylglycerols, 21 glycerophospholipids, cholesteryl ester (18:0), and ceramide (d18:1/16:0) compared with MD. VD increased triacylglycerols with long-chain polyunsaturated fatty acyls while decreased triacylglycerols with saturated fatty acyls, phosphatidylcholines, and sphingomyelins than MD. The Sullivan extent score (SES) exhibited on coronary angiograms were inversely associated with triacylglycerols with long-chain unsaturated fatty acyls. Phosphatidylcholines that were lower with VD were positively associated with SES and the total number of stenotic lesions. The VD favorably changed levels of several lipotoxic lipids that have previously been associated with increased risk of coronary events in CAD patients.",2020,"The VD increased levels of 11 triacylglycerols and lowered 7 triacylglycerols, 21 glycerophospholipids, cholesteryl ester (18:0), and ceramide (d18:1/16:0) compared with MD.","['Patients with Coronary Artery Disease', 'CAD patients', '31 CAD patients on standard medical therapy']","['Lacto-Ovo-Vegetarian Diet', 'VD and isocaloric meat diet (MD', 'lacto-ovo-vegetarian diet (VD']","['VD increased levels of 11 triacylglycerols and lowered 7 triacylglycerols, 21 glycerophospholipids, cholesteryl ester (18:0), and ceramide', 'total number of stenotic lesions', 'risk of coronary events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0311165', 'cui_str': 'Lacto-ovo-vegetarian diet'}, {'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0311164', 'cui_str': 'Vegetarian diet'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0162448', 'cui_str': 'Phosphoglycerides'}, {'cui': 'C0008387', 'cui_str': 'Cholesterol ester'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",31.0,0.020317,"The VD increased levels of 11 triacylglycerols and lowered 7 triacylglycerols, 21 glycerophospholipids, cholesteryl ester (18:0), and ceramide (d18:1/16:0) compared with MD.","[{'ForeName': 'Demir', 'Initials': 'D', 'LastName': 'Djekic', 'Affiliation': 'Department of Cardiology, Faculty of Health, Örebro University Hospital, 701 85 Örebro, Sweden.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': ""School of Food Engineering and Nutritional Science, Shaanxi Normal University, 710061 Xi'an, China.""}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Calais', 'Affiliation': 'Department of Cardiology, Faculty of Health, Örebro University Hospital, 701 85 Örebro, Sweden.'}, {'ForeName': 'Frida', 'Initials': 'F', 'LastName': 'Carlsson', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, 412 96 Gothenburg, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Landberg', 'Affiliation': 'Division of Food and Nutrition Science, Department of Biology and Biological Engineering, Chalmers University of Technology, 412 96 Gothenburg, Sweden.'}, {'ForeName': 'Tuulia', 'Initials': 'T', 'LastName': 'Hyötyläinen', 'Affiliation': 'Department of Chemistry, Örebro University, 701 82 Örebro, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Frøbert', 'Affiliation': 'Department of Cardiology, Faculty of Health, Örebro University Hospital, 701 85 Örebro, Sweden.'}]",Nutrients,['10.3390/nu12113586']
2763,33238677,[Feasibility study of contrast injection scheme based on body mass and iodine flow rate in coronary computed tomography angiography with wide detector CT].,"Objective: To investigate the feasibility of coronary computed tomography angiography (CCTA) with the individualized contrast medium injection scheme based on body mass and iodine flow rate by using wide detector CT at 100 kV. Methods: From May 2018 to July 2018,270 patients with clinically suspected coronary artery disease underwent CCTA in TEDA International Cardiovascular Hospital. They were randomly divided into three groups, 90 cases in each group: group A was 0.5 ml/kg, group B was 0.6 ml/kg, the flow rate of contrast medium injection in group A and group B was (body mass×25 mg)/the concentration of contrast medium,group C was 0.8 ml/kg and the flow rate of contrast medium was 5 ml/s. Iohexol (iodine concentration 350 mgI/ml) was used in all three groups. The CT values of the aorta root in the three groups, the CT value of the middle segment of LAD and RCA, SNR、CNR、 SD of the aortic root, subjective score of coronary artery and effective dose (ED) were compared. Results: There was no significant difference in CT value of aortic root, CT value of middle LAD and RCA, SNR、CNR、 SD of the aortic root, subjective score of coronary artery among group A, group B and group C (all P> 0.05). The flow rates of the three groups of contrast agents were statistically different (4.5±0.5 vs 4.5±0.5 vs 5, P= 0.015), and there was no statistical difference between group A and group B ( P> 0.05) but lower than group C ( P= 0.015); the amount of contrast agent in the three groups was statistically different (32±3 vs 38±4 vs 53±7, P< 0.001), group A 0.05).","['2018 to July 2018,270 patients with clinically suspected coronary artery disease underwent CCTA in TEDA International Cardiovascular Hospital']","['coronary computed tomography angiography with wide detector CT', 'coronary computed tomography angiography (CCTA', 'Iohexol (iodine concentration 350 mgI/ml', 'contrast injection scheme']","['body mass and iodine flow rate', 'CT value of the middle segment of LAD and RCA, SNR、CNR、 SD of the aortic root, subjective score of coronary artery and effective dose (ED', 'ED', 'flow rates', 'CT values of the aorta root', 'CT value of aortic root, CT value of middle LAD and RCA, SNR、CNR、 SD of the aortic root, subjective score of coronary artery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0226032', 'cui_str': 'Structure of anterior descending branch of left coronary artery'}, {'cui': 'C0610301', 'cui_str': 'RCA II'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}]",,0.0151894,"There was no significant difference in CT value of aortic root, CT value of middle LAD and RCA, SNR、CNR、 SD of the aortic root, subjective score of coronary artery among group A, group B and group C (all P> 0.05).","[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Liu', 'Affiliation': 'TEDA International Cardiovascular Hospital, Tianjin 300457, China.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'TEDA International Cardiovascular Hospital, Tianjin 300457, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'TEDA International Cardiovascular Hospital, Tianjin 300457, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'TEDA International Cardiovascular Hospital, Tianjin 300457, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Yuan', 'Affiliation': 'TEDA International Cardiovascular Hospital, Tianjin 300457, China.'}, {'ForeName': 'L J', 'Initials': 'LJ', 'LastName': 'Fan', 'Affiliation': 'TEDA International Cardiovascular Hospital, Tianjin 300457, China.'}]",Zhonghua yi xue za zhi,['10.3760/cma.j.cn112137-20200411-01161']
2764,33245517,Effects of paroxetine on the pharmacokinetics of atomoxetine and its metabolites in different CYP2D6 genotypes.,"The aim of this study was to investigate the effects of paroxetine, a potent inhibitor of CYP2D6, on the pharmacokinetics of atomoxetine and its two metabolites, 4-hydroxyatomoxetine and N-desmethylatomoxetine, in different CYP2D6 genotypes. Twenty-six healthy subjects were recruited and divided into CYP2D6*wt/*wt (*wt=*1 or *2, n = 10), CYP2D6*wt/*10 (n = 9), and CYP2D6*10/*10 groups (n = 7). In atomoxetine phase, all subjects received a single oral dose of atomoxetine (20 mg). In paroxetine phase, after administration of a single oral dose of paroxetine (20 mg) for six consecutive days, all subjects received a single oral dose of atomoxetine with paroxetine. Plasma concentrations of atomoxetine and its metabolites were determined up to 24 h after dosing. During atomoxetine phase, there were significant differences in C max and AUC 0-24 of atomoxetine and N-desmethylatomoxetine among three genotype groups, whereas significant differences were not found in relation to CYP2D6*10 allele after administration of paroxetine. AUC ratios of 4-hydroxyatomoxetine and N-desmethylatomoxetine to atomoxetine were significantly different among three genotype groups during atomoxetine phase (all, P < 0.001), but after paroxetine treatment significant differences were not found. After paroxetine treatment, AUC 0-24 of atomoxetine was increased by 2.3-, 1.7-, and 1.3-fold, in CYP2D6*wt/*wt, CYP2D6*wt/*10, and CYP2D6*10/*10 groups in comparison to atomoxetine phase, respectively. AUC ratio of 4-hydroxyatomoxetine to atomoxetine in each group was significantly decreased, whereas AUC ratio of N-desmethylatomoxetine to atomoxetine significantly increased after administration of paroxetine. In conclusion, paroxetine coadministration significantly affected pharmacokinetic parameters of atomoxetine and its two metabolites, 4-hydroxyatomoxetine and N-desmethylatomoxetine. When atomoxetine was administered alone, C max , AUC 0-24 and CL/F of atomoxetine were significantly different among the three CYP2D6 genotype groups. However, after paroxetine coadministration, no significant differences in these pharmacokinetic parameters were observed among the CYP2D6 genotype groups.",2020,"AUC ratios of 4-hydroxyatomoxetine and N-desmethylatomoxetine to atomoxetine were significantly different among three genotype groups during atomoxetine phase (all, P < 0.001), but after paroxetine treatment significant differences were not found.",['Twenty-six healthy subjects'],"['atomoxetine', 'paroxetine', 'atomoxetine with paroxetine', '4-hydroxyatomoxetine and N-desmethylatomoxetine']","['Plasma concentrations of atomoxetine and its metabolites', 'AUC ratios of 4-hydroxyatomoxetine and N-desmethylatomoxetine to atomoxetine', 'AUC ratio of 4-hydroxyatomoxetine', 'AUC ratio of N-desmethylatomoxetine', 'pharmacokinetic parameters', 'C max and AUC 0-24 of atomoxetine and N-desmethylatomoxetine']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C1122454', 'cui_str': '4-hydroxyatomoxetine'}, {'cui': 'C1122876', 'cui_str': 'N-desmethylatomoxetine'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1122454', 'cui_str': '4-hydroxyatomoxetine'}, {'cui': 'C1122876', 'cui_str': 'N-desmethylatomoxetine'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",26.0,0.017208,"AUC ratios of 4-hydroxyatomoxetine and N-desmethylatomoxetine to atomoxetine were significantly different among three genotype groups during atomoxetine phase (all, P < 0.001), but after paroxetine treatment significant differences were not found.","[{'ForeName': 'Eui Hyun', 'Initials': 'EH', 'LastName': 'Jung', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'College of Pharmacy, Dankook University, Cheonan, 31116, Republic of Korea.'}, {'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Pureum', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Chang Woo', 'Initials': 'CW', 'LastName': 'Lim', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Chang-Keun', 'Initials': 'CK', 'LastName': 'Cho', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Choon-Gon', 'Initials': 'CG', 'LastName': 'Jang', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Seok-Yong', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea. sylee@skku.ac.kr.'}, {'ForeName': 'Jung-Woo', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'College of Pharmacy, Keimyung University, Daegu, 42601, Republic of Korea. jwbae11@kmu.ac.kr.'}]",Archives of pharmacal research,['10.1007/s12272-020-01300-8']
2765,33237877,A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial.,"BACKGROUND
During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies.
OBJECTIVE
We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being.
METHODS
Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram.
RESULTS
All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020.
CONCLUSIONS
This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times.
TRIAL REGISTRATION
ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/24264.",2020,"Wider scale provision of the digital Hope Programme has potential to improve the lives of thousands of PWC and reduce the burden on healthcare providers during these unprecedented times.
","['All people who had requested access to the Hope Programme from Macmillan Cancer Support (N=61', 'people living with cancer during the COVID-19 pandemic', 'Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks']",['digital Hope Programme immediately (IG) or join a six-week waiting list (WLCG'],"['anxiety and depression and improved wellbeing for PWC', 'recruitment, drop-out and adherence rates, estimations of sample and effect size']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.212471,"Wider scale provision of the digital Hope Programme has potential to improve the lives of thousands of PWC and reduce the burden on healthcare providers during these unprecedented times.
","[{'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Wright', 'Affiliation': 'Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Clyne', 'Affiliation': 'National Institute for Health Research, Research Design Service South West, Peninsula Medical School, University of Plymouth, Plymouth, United Kingdom.'}, {'ForeName': 'Cain C T', 'Initials': 'CCT', 'LastName': 'Clark', 'Affiliation': 'Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Matouskova', 'Affiliation': 'Hope For The Community, Community Interest Company, The Enterprise Hub, Coventry, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Centre for Intelligent Healthcare, Faculty of Health and Life Sciences, Coventry University, Coventry, United Kingdom.'}]",JMIR research protocols,['10.2196/24264']
2766,33238898,CCT: continuous care trial - a randomized controlled trial of the provision of continuous care during labor by maternity care assistants in the Netherlands.,"BACKGROUND
In 2009, the Steering Committee for Pregnancy and Childbirth in the Netherlands recommended the implementation of continuous care during labor in order to improve perinatal outcomes. However, in current care, routine maternity caregivers are unable to provide this type of care, resulting in an implementation rate of less than 30%. Maternity care assistants (MCAs), who already play a nursing role in low risk births in the second stage of labor and in homecare during the postnatal period, might be able to fill this gap. In this study, we aim to explore the (cost) effectiveness of adding MCAs to routine first- and second-line maternity care, with the idea that these MCAs would offer continuous care to women during labor.
METHODS
A randomized controlled trial (RCT) will be performed comparing continuous care (CC) with care-as-usual (CAU). All women intending to have a vaginal birth, who have an understanding of the Dutch language and are > 18 years of age, will be eligible for inclusion. The intervention consists of the provision of continuous care by a trained MCA from the moment the supervising maternity caregiver establishes that labor has started. The primary outcome will be use of epidural analgesia (EA). Our secondary outcomes will be referrals from primary care to secondary care, caesarean delivery, instrumental delivery, adverse outcomes associated with epidural (fever, augmentation of labor, prolonged labor, postpartum hemorrhage, duration of postpartum stay in hospital for mother and/or newborn), women's satisfaction with the birth experience, cost-effectiveness, and a budget impact analysis. Cost effectiveness will be calculated by QALY per prevented EA based on the utility index from the EQ-5D and the usage of healthcare services. A standardized sensitivity analysis will be carried out to quantify the outcome in addition to a budget impact analysis. In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992).
DISCUSSION
We expect that adding MCAs to the routine maternity care team will result in a decrease in the use of epidural analgesia and subsequent costs without a reduction in patient satisfaction. It will therefore be a cost-effective intervention.
TRIAL REGISTRATION
Trial Registration: Netherlands Trial Register, NL8065 . Registered 3 October 2019 - Retrospectively registered.",2020,"In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992).
","['All women intending to have a vaginal birth, who have an understanding of the Dutch language and are >\u200918\u2009years of age', 'labor by maternity care assistants in the Netherlands']","['MCAs', 'CCT', 'continuous care (CC) with care-as-usual (CAU']","['epidural analgesia (EA', 'Cost effectiveness', 'attrition rate', ""secondary care, caesarean delivery, instrumental delivery, adverse outcomes associated with epidural (fever, augmentation of labor, prolonged labor, postpartum hemorrhage, duration of postpartum stay in hospital for mother and/or newborn), women's satisfaction with the birth experience, cost-effectiveness, and a budget impact analysis""]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0376241', 'cui_str': 'Dutch language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C4049005', 'cui_str': 'Cataract, total congenital with posterior sutural opacities in Heterozygotes'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0473305', 'cui_str': 'Augmentation of labor'}, {'cui': 'C0152154', 'cui_str': 'Prolonged labor'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",496.0,0.149225,"In order to show a reduction from 25 to 17% in the primary outcome (alpha 0.05 and bèta 0.20), taking into account an extra 10% sample size for multi-level analysis and an attrition rate of 10%, 2 × 496 women will be needed (n = 992).
","[{'ForeName': 'Adrie', 'Initials': 'A', 'LastName': 'Lettink', 'Affiliation': 'Department of Obstetrics & Gynecology, Maastricht University Medical Center (MUMC+), Peter Debyelaan 25, 6229 HX, Maastricht, The Netherlands. adrie.lettink@mumc.nl.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Chaibekava', 'Affiliation': 'Department of Obstetrics & Gynecology, Maastricht University Medical Center (MUMC+), Maastricht University, Peter Debyelaan 25, 6229 HX, Maastricht, The Netherlands.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Smits', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Department of Epidemiology, Maastricht University, Peter Debyeplein 1, 6229 HA, Maastricht, The Netherlands.'}, {'ForeName': 'Josje', 'Initials': 'J', 'LastName': 'Langenveld', 'Affiliation': 'Department of Obstetrics & Gynecology, Zuyderland Medical Center, Heerlen, The Netherlands.'}, {'ForeName': 'Rafli', 'Initials': 'R', 'LastName': 'van de Laar', 'Affiliation': 'Department of Obstetrics & Gynecology Viecuri Medical Center, Venlo, The Netherlands.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Peeters', 'Affiliation': 'Department of Maternity Care Assistants, Cicogna Kraamzorg, Oude Rijksweg 32, 6271 AA, Gulpen, The Netherlands.'}, {'ForeName': 'Marie-Louise', 'Initials': 'ML', 'LastName': 'Verstappen', 'Affiliation': 'Department of Maternity Care Assistants, Geboortezorg Limburg, Minckelersstraat 2, 6372 PP, Landgraaf, The Netherlands.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Dirksen', 'Affiliation': 'Health Technology Assessment, Maastricht University, Peter Debyeplein 1, 6229 HA, Maastricht, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Nieuwenhuijze', 'Affiliation': 'Research Center for Midwifery Science, Zuyd University, Universiteitssingel 60, 6229 ER, Maastricht, The Netherlands.'}, {'ForeName': 'Hubertina', 'Initials': 'H', 'LastName': 'Scheepers', 'Affiliation': 'Gynecologist, Department of Obstetrics & Gynecology, Maastricht University Medical Center (MUMC+), Maastricht University, Peter Debyelaan 25, 6229 HX, Maastricht, The Netherlands.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03336-6']
2767,33238907,The effectiveness of a collaborative infertility counseling (CIC) on pregnancy outcome in women undergoing in vitro fertilization: a randomized trial.,"BACKGROUND
The optimal objective of infertility treatments is to increase pregnancy rate. The aim of this study was to assess the effectiveness of a collaborative counseling program on pregnancy rate in women undergoing in vitro treatment.
METHODS
This was a parallel group randomized trial on a sample of 60 women attending to an infertility research center affiliated to Mashhad University of Medical Sciences for fertility treatment. Women were randomly assigned to an intervention or a control group. Then, a five-session program offered to the intervention group while the control group received nothing expect the usual care. The primary outcome for the study was positive pregnancy test at the end of study. Statistical analyses including independent samples t-test were performed to explore the data.
RESULTS
The outcome analysis showed that there were no significant differences in pregnancy rate between the intervention and the control groups (P = 0.298). Also, there were no significant differences in follicle and embryo numbers between two groups. However, a significant difference was observed between two groups in terms of oocyte numbers where the intervention group had more oocyte (P = 0.014).
CONCLUSION
Overall the findings indicated that the collaborative infertility counseling did not improve treatment success in infertile women undergoing in vitro fertilization.
TRIAL REGISTRATION
IRCT201110267915N1. Registered 2014.07.25-Retrospectively registered ( http://en.irct.ir/trial/8359 ).",2020,The outcome analysis showed that there were no significant differences in pregnancy rate between the intervention and the control groups (P = 0.298).,"['women undergoing in vitro treatment', 'women undergoing in vitro fertilization', 'infertile women undergoing in vitro fertilization', '60 women attending to an infertility research center affiliated to Mashhad University of Medical Sciences for fertility treatment']","['control group received nothing expect the usual care', 'collaborative infertility counseling (CIC', 'collaborative infertility counseling', 'collaborative counseling program']","['pregnancy rate', 'oocyte numbers', 'positive pregnancy test', 'pregnancy outcome', 'follicle and embryo numbers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0055670', 'cui_str': 'CHVP protocol'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0018120', 'cui_str': 'Ovarian follicle structure'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}]",60.0,0.131326,The outcome analysis showed that there were no significant differences in pregnancy rate between the intervention and the control groups (P = 0.298).,"[{'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Rasoulzadeh Bidgoli', 'Affiliation': 'Trauma Nursing Research Center, Kashan University of Medical Sciences, Kashan, Iran. mehr232007@yahoo.com.'}, {'ForeName': 'Robab', 'Initials': 'R', 'LastName': 'Latifnejad Roudsari', 'Affiliation': 'Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Population Health Research Group, Health Metrics Research Center, Iranian Institute for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03417-6']
2768,33238373,Effect of Acute Sprint Exercise on Myokines and Food Intake Hormones in Young Healthy Men.,"Physical exercise is known to influence hormonal mediators of appetite, but the effect of short-term maximal intensity exercise on plasma levels of appetite hormones and cytokines has been little studied. We investigated the effect of a 30 s Wingate Test, followed by a postprandial period, on appetite sensations, food intake, and appetite hormones. Twenty-six physically active young males rated their subjective feelings of hunger, prospective food consumption, and fatigue on visual analogue scales at baseline, after exercise was completed, and during the postprandial period. Blood samples were obtained for the measurement of nesfatin-1, ghrelin, leptin, insulin, pancreatic polypeptide (PP), human growth factor (hGH) and cytokine interleukin-6 (IL-6), irisin and plasma lactate concentrations, at 30 min before exercise, immediately (210 s) after exercise, and 30 min following a meal and at corresponding times in control sedentary males without ad libitum meal intake, respectively. Appetite perceptions and food intake were decreased in response to exercise. Plasma levels of irisin, IL-6, lactate, nesfatin-1 and ghrelin was increased after exercise and then it was returned to postprandial/control period in both groups. A significant rise in plasma insulin, hGH and PP levels after exercise was observed while meal intake potentiated this response. In conclusion, an acute short-term fatiguing exercise can transiently suppress hunger sensations and food intake in humans. We postulate that this physiological response involves exercise-induced alterations in plasma hormones and the release of myokines such as irisin and IL-6, and supports the notion of existence of the skeletal muscle-brain-gut axis. Nevertheless, the detailed relationship between acute exercise releasing myokines, appetite sensations and impairment of this axis leading to several diseases should be further examined.",2020,"Plasma levels of irisin, IL-6, lactate, nesfatin-1 and ghrelin was increased after exercise and then it was returned to postprandial/control period in both groups.","['Young Healthy Men', 'Twenty-six physically active young males', 'humans']","['Acute Sprint Exercise', 'Physical exercise']","['hunger sensations and food intake', 'appetite sensations, food intake, and appetite hormones', 'nesfatin-1, ghrelin, leptin, insulin, pancreatic polypeptide (PP), human growth factor (hGH) and cytokine interleukin-6 (IL-6), irisin and plasma lactate concentrations', 'Plasma levels of irisin, IL-6, lactate, nesfatin-1 and ghrelin', 'Appetite perceptions and food intake', 'plasma insulin, hGH and PP levels', 'Myokines and Food Intake Hormones', 'subjective feelings of hunger, prospective food consumption, and fatigue on visual analogue scales']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0030298', 'cui_str': 'Pancreatic peptide'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C1305923', 'cui_str': 'Polypeptide'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",26.0,0.0348508,"Plasma levels of irisin, IL-6, lactate, nesfatin-1 and ghrelin was increased after exercise and then it was returned to postprandial/control period in both groups.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bilski', 'Affiliation': 'Department of Biomechanics and Kinesiology, Faculty of Health Sciences, Jagiellonian University Medical College, 20 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Agnieszka Irena', 'Initials': 'AI', 'LastName': 'Mazur-Bialy', 'Affiliation': 'Department of Biomechanics and Kinesiology, Faculty of Health Sciences, Jagiellonian University Medical College, 20 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Surmiak', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Jagiellonian University Medical College, 16 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Hubalewska-Mazgaj', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Jagiellonian University Medical College, 16 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Pokorski', 'Affiliation': 'Department of Biomechanics and Kinesiology, Faculty of Health Sciences, Jagiellonian University Medical College, 20 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Nitecki', 'Affiliation': 'Department of Biomechanics and Kinesiology, Faculty of Health Sciences, Jagiellonian University Medical College, 20 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Nitecka', 'Affiliation': 'Department of Biomechanics and Kinesiology, Faculty of Health Sciences, Jagiellonian University Medical College, 20 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Pokorska', 'Affiliation': 'Department of Biomechanics and Kinesiology, Faculty of Health Sciences, Jagiellonian University Medical College, 20 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Aneta', 'Initials': 'A', 'LastName': 'Targosz', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Jagiellonian University Medical College, 16 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Ptak-Belowska', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Jagiellonian University Medical College, 16 Grzegorzecka Street, 31-531 Cracow, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'A Zoladz', 'Affiliation': 'Department of Muscle Physiology, Chair of Physiology and Biochemistry, Faculty of Rehabilitation, University School of Physical Education, 31-571 Cracow, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Brzozowski', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Jagiellonian University Medical College, 16 Grzegorzecka Street, 31-531 Cracow, Poland.'}]",International journal of molecular sciences,['10.3390/ijms21228848']
2769,33245245,The Preliminary Efficacy of a Sleep Self-management Intervention Using a Personalized Health Monitoring Device during Pregnancy.,"Background : Sleep disturbances are common during pregnancy and are associated with the development of adverse pregnancy outcomes. Personal health monitors (PHM) can facilitate change in health behaviors, though few studies have examined their use in improving sleep during pregnancy. This pilot study aimed to characterize sleep changes during pregnancy in women participating in a self-management intervention using a PHM. Participants/Methods : Participants with low risk, singleton pregnancies from Western Massachusetts were randomized at 24 weeks gestation to receive sleep education only (n = 12) or sleep education, and PHM intervention (n = 12). The single-session sleep education was given at baseline by a registered nurse. Sleep quality, duration, efficiency, disturbances, daytime sleepiness, and fatigue were assessed at baseline and 12 weeks follow-up using questionnaires. We described mean ± standard deviation within and between-group changes in each sleep outcome from baseline to 12 weeks follow-up. Results : The PHM arm experienced larger sleep quality improvements and daytime sleepiness than the sleep-education only arm, but the differences were not statistically significant. In the PHM arm, the Pittsburgh Sleep Quality Index (PSQI) score decreased (i.e., sleep quality increased) 1.22 ± 2.39 ( p = .16), and the Epworth Sleepiness Scale (ESS) score decreased (i.e., daytime sleepiness decreased) 1.11 ± 2.08 ( p = .15). In the sleep-education arm PSQI decreased 0.57 ± 2.37 ( p = .55) and ESS decreased 1.29 ± 2.93 ( p = .29). Neither group experienced statistically significant changes in sleep duration, efficiency, disturbances, or fatigue. Conclusion : Sleep education with PHM may improve or prevent decreases in sleep outcomes during pregnancy. Further investigation in larger trials is warranted.",2020,In the sleep-education arm PSQI decreased 0.57 ± 2.37 ( p = .55) and ESS decreased 1.29 ± 2.93 ( p = .29).,"['women participating in a self-management intervention using a PHM', 'Participants with low risk, singleton pregnancies from Western Massachusetts', 'Participants/Methods ']","['sleep education only (n\xa0=\xa012) or sleep education, and PHM intervention', 'Sleep Self-management Intervention', ' ', 'Personal health monitors (PHM']","['Sleep disturbances', 'Pittsburgh Sleep Quality Index (PSQI) score', 'Sleep quality, duration, efficiency, disturbances, daytime sleepiness, and fatigue', 'larger sleep quality improvements and daytime sleepiness', 'sleep outcomes', 'sleep duration, efficiency, disturbances, or fatigue', 'Epworth Sleepiness Scale (ESS) score']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C4706348', 'cui_str': 'ESS (Epworth Sleepiness Scale) score'}]",,0.0570543,In the sleep-education arm PSQI decreased 0.57 ± 2.37 ( p = .55) and ESS decreased 1.29 ± 2.93 ( p = .29).,"[{'ForeName': 'Wei-Hsin', 'Initials': 'WH', 'LastName': 'Hsiao', 'Affiliation': 'Department of Epidemiology, University of Pittsburgh , Pittsburgh, United States.'}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Paterno', 'Affiliation': 'College of Nursing, University of Massachusetts Amherst , Amherst Center, United States.'}, {'ForeName': 'Favorite', 'Initials': 'F', 'LastName': 'Iradukunda', 'Affiliation': 'College of Nursing, University of Massachusetts Amherst , Amherst Center, United States.'}, {'ForeName': 'Marquis', 'Initials': 'M', 'LastName': ""Hawkins'"", 'Affiliation': 'Department of Epidemiology, University of Pittsburgh , Pittsburgh, United States.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1851230']
2770,33245288,"Testing the Efficacy of a Multicomponent, Self-Guided, Smartphone-Based Meditation App: Three-Armed Randomized Controlled Trial.","BACKGROUND
A growing number of randomized controlled trials (RCTs) suggest psychological benefits associated with meditation training delivered via mobile health. However, research in this area has primarily focused on mindfulness, only one of many meditative techniques.
OBJECTIVE
This study aims to evaluate the efficacy of 2 versions of a self-guided, smartphone-based meditation app-the Healthy Minds Program (HMP)-which includes training in mindfulness (Awareness), along with practices designed to cultivate positive relationships (Connection) or insight into the nature of the self (Insight).
METHODS
A three-arm, fully remote RCT compared 8 weeks of one of 2 HMP conditions (Awareness+Connection and Awareness+Insight) with a waitlist control. Adults (≥18 years) without extensive previous meditation experience were eligible. The primary outcome was psychological distress (depression, anxiety, and stress). Secondary outcomes were social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness. Measures were completed at pretest, midtreatment, and posttest between October 2019 and April 2020. Longitudinal data were analyzed using intention-to-treat principles with maximum likelihood.
RESULTS
A total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment. The majority (166/228, 72.8%) of those assigned to HMP conditions downloaded the app. The 2 HMP conditions did not differ from one another in terms of changes in any outcome. Relative to the waitlist control, the HMP conditions showed larger improvements in distress, social connectedness, mindfulness, and measures theoretically linked to insight training (d=-0.28 to 0.41; Ps≤.02), despite modest exposure to connection- and insight-related practice. The results were robust to some assumptions about nonrandom patterns of missing data. Improvements in distress were associated with days of use. Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress were identified.
CONCLUSIONS
This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness. Future studies should attempt to increase study retention and user engagement.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04139005; https://clinicaltrials.gov/ct2/show/NCT04139005.",2020,"This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness.","['Adults (≥18 years) without extensive previous meditation experience were eligible', 'A total of 343 participants were randomized and 186 (54.2%) completed at least one posttest assessment']","['Multicomponent, Self-Guided, Smartphone-Based Meditation App', 'self-guided, smartphone-based meditation app-the Healthy Minds Program (HMP)-which includes training in mindfulness (Awareness', 'HMP']","['social connection, empathy, compassion, self-reflection, insight, rumination, defusion, and mindfulness', 'psychological distress (depression, anxiety, and stress', 'distress', 'Candidate mediators (social connection, insight, rumination, defusion, and mindfulness) and moderators (baseline rumination, defusion, and empathy) of changes in distress', 'distress, social connectedness, mindfulness, and measures theoretically linked to insight training']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517808', 'cui_str': '54.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",343.0,0.0982615,"This study provides initial evidence of efficacy for the HMP app in reducing distress and improving outcomes related to well-being, including social connectedness.","[{'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Imhoff-Smith', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bolt', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison, Madison, WI, United States.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Wilson-Mendenhall', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Cortland J', 'Initials': 'CJ', 'LastName': 'Dahl', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Davidson', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Rosenkranz', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin, Madison, WI, United States.'}]",JMIR mental health,['10.2196/23825']
2771,33242457,Pharmacokinetics and safety of early nevirapine-based antiretroviral therapy for neonates at high risk for perinatal HIV infection: a phase 1/2 proof of concept study.,"BACKGROUND
With increasing intention to treat HIV as early as possible, evidence to confirm the safety and therapeutic drug concentrations of a nevirapine-based antiretroviral regimen in the early neonatal period is needed. This study aims to establish dosing of nevirapine for very early treatment of HIV-exposed neonates at high risk of HIV acquisition.
METHODS
IMPAACT P1115 is a multinational phase 1/2 proof-of-concept study in which presumptive treatment for in-utero HIV infection is initiated within 48 h of birth in HIV-exposed neonates at high risk of HIV acquisition. Participants were neonates who were at least 34 weeks gestational age at birth and enrolled within 48 h of birth, born to women with presumed or confirmed HIV infection who had not received antiretrovirals during this pregnancy. The regimen consisted of two nucleoside reverse transcriptase inhibitors plus nevirapine dosed at 6 mg/kg twice daily for term neonates (≥37 weeks gestational age) or 4 mg/kg twice daily for 1 week and 6 mg/kg twice daily thereafter for preterm neonates (34 to <37 weeks gestational age). Here, we report the secondary outcomes of the study: nevirapine exposures in study weeks 1 and 2 and treatment-associated grade 3 or 4 adverse events at least possibly related to study treatment up to study week 4. A population pharmacokinetic model to assess nevirapine exposure was developed from dried blood spot and plasma nevirapine concentrations at study weeks 1 and 2. Nevirapine exposure was assessed in all patients with available blood samples and safety was assessed in all participants. This trial is registered at ClinicalTrials.gov (NCT02140255).
FINDINGS
Between Jan 23, 2015, and Sept 4, 2017, 438 neonates were enrolled and included in analyses; 36 had in-utero HIV infection and 389 (89%) were born at term. Neonates without confirmed in-utero HIV infection received nevirapine for a median of 13 days (IQR 7-14). Measured dried blood spot nevirapine concentrations were higher than the minimum HIV treatment target (3 μg/mL) in 314 (90%, 95% CI 86-93) of 349 neonates at week 1 and 174 (87%, 81-91) of 201 at week 2. In Monte-Carlo simulations, week 1 nevirapine concentrations exceeded 3 μg/mL in 80% of term neonates and 82% of preterm neonates. DAIDS grade 3 or 4 adverse events at least possibly related to antiretrovirals occurred in 30 (7%, 95% CI 5-10) of 438 infants but did not lead to nevirapine cessation in any neonates; neutropenia (25 [6%] neonates) and anaemia (six [1%]) were most common.
INTERPRETATION
Nevirapine at the dose studied was confirmed to be safe and provides therapeutic exposure concentrations. These data support nevirapine as a component of presumptive HIV treatment in high-risk neonates.
FUNDING
National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health.",2020,"Measured dried blood spot nevirapine concentrations were higher than the minimum HIV treatment target (3 μg/mL) in 314 (90%, 95% CI 86-93) of 349 neonates at week 1 and 174 (87%, 81-91) of 201 at week 2.","['utero HIV infection is initiated within 48 h of birth in HIV-exposed neonates at high risk of HIV acquisition', 'HIV-exposed neonates at high risk of HIV acquisition', 'Participants were neonates who were at least 34 weeks gestational age at birth and enrolled within 48 h of birth, born to women with presumed or confirmed HIV infection who had not received antiretrovirals during this pregnancy', 'neonates at high risk for perinatal HIV infection', 'Between Jan 23, 2015, and Sept 4, 2017, 438 neonates were enrolled and included in analyses; 36 had in-utero HIV infection and 389 (89%) were born at term']","['nucleoside reverse transcriptase inhibitors plus nevirapine', 'Nevirapine', 'nevirapine-based antiretroviral therapy', 'nevirapine']","['dried blood spot and plasma nevirapine concentrations', 'dried blood spot nevirapine concentrations', 'DAIDS grade 3 or 4 adverse events']","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3160847', 'cui_str': 'Perinatal HIV infection'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517752', 'cui_str': '389'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0028621', 'cui_str': 'Nucleoside'}, {'cui': 'C0282519', 'cui_str': 'Reverse transcriptase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",438.0,0.287822,"Measured dried blood spot nevirapine concentrations were higher than the minimum HIV treatment target (3 μg/mL) in 314 (90%, 95% CI 86-93) of 349 neonates at week 1 and 174 (87%, 81-91) of 201 at week 2.","[{'ForeName': 'Theodore D', 'Initials': 'TD', 'LastName': 'Ruel', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA. Electronic address: theodore.ruel@ucsf.edu.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Camlin', 'Initials': 'C', 'LastName': 'Tierney', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Bryan S', 'Initials': 'BS', 'LastName': 'Nelson', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Coletti', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bryson', 'Affiliation': 'University of Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Cotton', 'Affiliation': 'Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Spector', 'Affiliation': 'University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'LeBlanc', 'Affiliation': 'Frontier Science and Technology Research Foundation, Amherst, NY, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Reding', 'Affiliation': 'Frontier Science and Technology Research Foundation, Amherst, NY, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Zimmer', 'Affiliation': 'Frontier Science and Technology Research Foundation, Amherst, NY, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Persaud', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mutsa', 'Initials': 'M', 'LastName': 'Bwakura-Dangarembizi', 'Affiliation': 'University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Kimesh L', 'Initials': 'KL', 'LastName': 'Naidoo', 'Affiliation': 'Nelson R Mandela School of Medicine, Durban, South Africa.'}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Hazra', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Jean-Philippe', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ellen G', 'Initials': 'EG', 'LastName': 'Chadwick', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30274-5']
2772,33243182,Vestibular rehabilitation in multiple sclerosis: study protocol for a randomised controlled trial and cost-effectiveness analysis comparing customised with booklet based vestibular rehabilitation for vestibulopathy and a 12 month observational cohort study of the symptom reduction and recurrence rate following treatment for benign paroxysmal positional vertigo.,"BACKGROUND
Symptoms arising from vestibular system dysfunction are observed in 49-59% of people with Multiple Sclerosis (MS). Symptoms may include vertigo, dizziness and/or imbalance. These impact on functional ability, contribute to falls and significant health and social care costs. In people with MS, vestibular dysfunction can be due to peripheral pathology that may include Benign Paroxysmal Positional Vertigo (BPPV), as well as central or combined pathology. Vestibular symptoms may be treated with vestibular rehabilitation (VR), and with repositioning manoeuvres in the case of BPPV. However, there is a paucity of evidence about the rate and degree of symptom recovery with VR for people with MS and vestibulopathy. In addition, given the multiplicity of symptoms and underpinning vestibular pathologies often seen in people with MS, a customised VR approach may be more clinically appropriate and cost effective than generic booklet-based approaches. Likewise, BPPV should be identified and treated appropriately.
METHODS/ DESIGN
People with MS and symptoms of vertigo, dizziness and/or imbalance will be screened for central and/or peripheral vestibulopathy and/or BPPV. Following consent, people with BPPV will be treated with re-positioning manoeuvres over 1-3 sessions and followed up at 6 and 12 months to assess for any re-occurrence of BPPV. People with central and/or peripheral vestibulopathy will be entered into a randomised controlled trial (RCT). Trial participants will be randomly allocated (1:1) to either a 12-week generic booklet-based home programme with telephone support or a 12-week VR programme consisting of customised treatment including 12 face-to-face sessions and a home exercise programme. Customised or booklet-based interventions will start 2 weeks after randomisation and all trial participants will be followed up 14 and 26 weeks from randomisation. The primary clinical outcome is the Dizziness Handicap Inventory at 26 weeks and the primary economic endpoint is quality-adjusted life-years. A range of secondary outcomes associated with vestibular function will be used.
DISCUSSION
If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS.
TRIAL REGISTRATION
ISRCTN Number: 27374299 Date of Registration 24/09/2018 Protocol Version 15 25/09/2019.",2020,"If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS.
","['benign paroxysmal positional vertigo', 'People with central and/or peripheral vestibulopathy', '49-59% of people with Multiple Sclerosis (MS', 'People with MS and symptoms of vertigo, dizziness and/or imbalance will be screened for central and/or peripheral vestibulopathy and/or BPPV', 'multiple sclerosis']","['booklet based vestibular rehabilitation for vestibulopathy', 'Vestibular rehabilitation', 'generic booklet-based home programme with telephone support or a 12-week VR programme consisting of customised treatment including 12 face-to-face sessions and a home exercise programme', 'vestibular rehabilitation (VR']","['vertigo, dizziness and/or imbalance', 'Dizziness Handicap Inventory at 26\u2009weeks and the primary economic endpoint is quality-adjusted life-years', 'recurrence rate']","[{'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0042571', 'cui_str': 'Vertigo'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.124344,"If customised VR is demonstrated to be clinically and cost-effective compared to generic booklet-based VR this will inform practice guidelines and the development of training packages for therapists in the diagnosis and treatment of vestibulopathy in people with MS.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Marsden', 'Affiliation': 'School of Health Professions, Faculty of Health: Medicine, Dentistry and Human Science, Peninsula Allied Health Centre, Derriford Rd, Derriford, Plymouth, PL6 8BH, UK. jonathan.marsden@plymouth.ac.uk.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pavlou', 'Affiliation': ""Academic Department of Physiotherapy, King's College London, Room 3.5 Shepherd's House, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dennett', 'Affiliation': 'School of Health Professions, Faculty of Health: Medicine, Dentistry and Human Science, Peninsula Allied Health Centre, Derriford Rd, Derriford, Plymouth, PL6 8BH, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gibbon', 'Affiliation': 'School of Health Professions, Faculty of Health: Medicine, Dentistry and Human Science, Peninsula Allied Health Centre, Derriford Rd, Derriford, Plymouth, PL6 8BH, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Knight-Lozano', 'Affiliation': 'School of Health Professions, Faculty of Health: Medicine, Dentistry and Human Science, Peninsula Allied Health Centre, Derriford Rd, Derriford, Plymouth, PL6 8BH, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jeu', 'Affiliation': ""Academic Department of Physiotherapy, King's College London, Room 3.5 Shepherd's House, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Flavell', 'Affiliation': ""Academic Department of Physiotherapy, King's College London, Room 3.5 Shepherd's House, Guy's Campus, London, SE1 1UL, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'School of Health Professions, Faculty of Health: Medicine, Dentistry and Human Science, Peninsula Allied Health Centre, Derriford Rd, Derriford, Plymouth, PL6 8BH, UK.'}, {'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Bamiou', 'Affiliation': ""EAR Institute University College London, 332 Gray's Inn Rd, London, WC1X 8EE, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Harris', 'Affiliation': 'Royal Eye Infirmary, Derriford Hospital, Plymouth, PL6 8DH, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hawton', 'Affiliation': ""Health Economics Group, University of Exeter, South Cloisters, St Luke's Campus, Exeter, EX1 2LU, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Goodwin', 'Affiliation': ""Health Economics Group, University of Exeter, South Cloisters, St Luke's Campus, Exeter, EX1 2LU, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jones', 'Affiliation': 'Medical Statistics Group and Peninsula Clinical Trials Unit, Faculty of Health: Medicine, Dentistry and Human Science, Plymouth Science Park, 1 Davy Rd, Derriford, Plymouth, PL6 8BX, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Creanor', 'Affiliation': 'Medical Statistics Group and Peninsula Clinical Trials Unit, Faculty of Health: Medicine, Dentistry and Human Science, Plymouth Science Park, 1 Davy Rd, Derriford, Plymouth, PL6 8BX, UK.'}]",BMC neurology,['10.1186/s12883-020-01983-y']
2773,33243209,The value of melatonin supplementation in postmenopausal women with Helicobacter pylori-associated dyspepsia.,"BACKGROUND
Dyspeptic syndrome is particularly common in postmenopausal women in the form of epigastric pain. The aim of the study was to assess the role of melatonin in chronic dyspepsia in this group of women, and examine the role of Helicobacter infection.
METHODS
The study comprised 152 subjects including 30 healthy women (Group I), 60 women with asymptomatic H.pylori infection (Group II), and 64 women with H. pylori infection with chronic dyspepsia (Group III). Endoscopic examination was performed, as well as histological assessment of gastric end duodenal mucosa, urease breath test (UBT-13C), and immunoenzymatic assessment of serum 17-β-estradiol, follicle stimulating hormone and melatonin, and urinary 6-sulfatoxymelatonin. In Group III, 14-day antibacterial treatment was introduced with pantoprazole, amoxicillin and levofloxacin followed a six-month treatment with placebo in 32 women (Group IIIa), and melatonin 1 mg/morning and 3 mg/at bedtime in the other 32 women (Group IIIb).
RESULTS
No significant differences were found between serum level of female hormone. Serum melatonin levels were similar between Group I (12.5 ± 2.72 pg/ml) and Group II (10.5 ± 3.73 pg/ml; p > 0,05). The level was significantly lower in Group III (5.72 ± 1.42 pg/ml; p < 0.001). Eradication of H.pylori was obtained in 75.0% women in Group IIIa, and in 84.3% in Group IIIb (p > 0.05). After six months, dyspeptic symptoms resolved in 43.7% patients in Group IIIa and 84.3% in Group IIIb (p < 0.001).
CONCLUSION
Melatonin supplementation is useful in treating H. pylori-associated dyspepsia, particularly in postmenopausal women with lower levels of this hormone.
TRIAL REGISTRATION
NCT04352062, date of registration: 15.04.2020.",2020,Serum melatonin levels were similar between Group I (12.5 ± 2.72 pg/ml) and Group II (10.5 ± ,"['postmenopausal women with lower levels of this hormone', 'postmenopausal women with Helicobacter pylori-associated dyspepsia', '152 subjects including 30 healthy women (Group I), 60 women with asymptomatic H.pylori infection (Group II), and 64 women with H. pylori infection with chronic dyspepsia (Group III', 'postmenopausal women in the form of epigastric pain', '32 women (Group IIIa), and']","['melatonin 1\xa0mg/morning and 3\xa0mg/at bedtime', 'placebo', 'melatonin', 'melatonin supplementation', 'Melatonin supplementation', 'pantoprazole, amoxicillin and levofloxacin']","['Eradication of H.pylori', 'histological assessment of gastric end duodenal mucosa, urease breath test (UBT-13C), and immunoenzymatic assessment of serum 17-β-estradiol, follicle stimulating hormone and melatonin, and urinary 6-sulfatoxymelatonin', 'Serum melatonin levels', 'chronic dyspepsia', 'dyspeptic symptoms', 'serum level of female hormone']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}]","[{'cui': 'C1128357', 'cui_str': 'Melatonin 1 MG'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}]","[{'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0227284', 'cui_str': 'Duodenal mucous membrane structure'}, {'cui': 'C0041945', 'cui_str': 'Urease'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0049713', 'cui_str': '6-sulfatoxymelatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}]",60.0,0.0763066,Serum melatonin levels were similar between Group I (12.5 ± 2.72 pg/ml) and Group II (10.5 ± ,"[{'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Chojnacki', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics of Medical University, Lodz, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Mędrek-Socha', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics of Medical University, Lodz, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Konrad', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics of Medical University, Lodz, Poland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Chojnacki', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics of Medical University, Lodz, Poland.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Błońska', 'Affiliation': 'Department of Clinical Nutrition and Gastroenterological Diagnostics of Medical University, Lodz, Poland. aleksandra.blonska@umed.lodz.pl.'}]",BMC women's health,['10.1186/s12905-020-01117-z']
2774,33243221,Metabolic syndrome in patients with type 2 diabetes and atherosclerotic cardiovascular disease: a post hoc analyses of the EMPA-REG OUTCOME trial.,"BACKGROUND
Patients with type 2 diabetes (T2D) and metabolic syndrome (MetS) are at greater cardiovascular risk than those with T2D without MetS. In the current report we aim to study the characteristics, cardio-renal outcomes and the effect of empagliflozin in patients with MetS enrolled in the EMPA-REG OUTCOME trial.
METHODS
A total of 7020 patients with T2D and atherosclerotic cardiovascular disease were treated with empagliflozin (10 mg or 25 mg) or placebo for a median of 3.1 years. The World Health Organization MetS criteria could be determined for 6985 (99.5%) patients. We assessed the association between baseline MetS and multiple cardio-renal endpoints using Cox regression models, and we studied the change in the individual component over time of the MetS using mixed effect models.
RESULTS
MetS at baseline was present in 5740 (82%) patients; these were more often white and had more often albuminuria and heart failure, had lower eGFR and HDL-cholesterol, and higher blood pressure, body mass index, waist circumference, and triglycerides. In the placebo group, patients with MetS had a higher risk of all outcomes including cardiovascular death: HR = 1.73 (95% CI 1.01-2.98), heart failure hospitalization: HR = 2.64 (95% CI 1.22, 5.72), and new or worsening nephropathy: HR = 3.11 (95% CI 2.17-4.46). The beneficial effect of empagliflozin was consistent on all cardio-renal outcomes regardless of presence of MetS.
CONCLUSIONS
A large proportion of the EMPA-REG OUTCOME population fulfills the criteria for MetS. Those with MetS had increased risk of adverse cardio-renal outcomes. Compared with placebo, empagliflozin improved cardio-renal outcomes in patients with and without MetS. Trial registration Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01131676.",2020,"In the placebo group, patients with MetS had a higher risk of all outcomes including cardiovascular death: HR = 1.73 (95% CI 1.01-2.98), heart failure hospitalization: HR = 2.64 (95% CI 1.22, 5.72), and new or worsening nephropathy: HR = 3.11 (95% CI 2.17-4.46).","['7020 patients with T2D and atherosclerotic cardiovascular disease', 'Patients with type 2 diabetes (T2D) and metabolic syndrome (MetS) are at greater cardiovascular risk than those with T2D without MetS', 'patients with MetS enrolled in the EMPA-REG OUTCOME trial', 'patients with type 2 diabetes and atherosclerotic cardiovascular disease']","['empagliflozin', 'placebo, empagliflozin', 'placebo']","['cardiovascular death', 'cardio-renal outcomes', 'risk of adverse cardio-renal outcomes', 'heart failure hospitalization', 'Metabolic syndrome', 'albuminuria and heart failure, had lower eGFR and HDL-cholesterol, and higher blood pressure, body mass index, waist circumference, and triglycerides']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0208940', 'cui_str': 'REG1A protein, human'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",7020.0,0.338396,"In the placebo group, patients with MetS had a higher risk of all outcomes including cardiovascular death: HR = 1.73 (95% CI 1.01-2.98), heart failure hospitalization: HR = 2.64 (95% CI 1.22, 5.72), and new or worsening nephropathy: HR = 3.11 (95% CI 2.17-4.46).","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': ""Centre d'Investigations Cliniques Plurithématique Inserm 1433, CHRU de Nancy, Inserm U1116, FCRIN INI- CRCT, Université de Lorraine, Nancy, France. j.ferreira@chru-nancy.fr.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway Ks, Asker, Norway.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Lauer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Mount Sinai Hospital, Lunenfeld-Tanenbaum Research Institute, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01174-6']
2775,33243231,Integrating nutrition into the mathematics curriculum in Australian primary schools: protocol for a randomised controlled trial.,"BACKGROUND
Nutrition education programs in schools have been effective in improving children's knowledge and behaviours related to food and nutrition. However, teachers find it challenging to implement such programs due to overcrowded curricula. Integrating nutrition with core subjects such as mathematics could potentially address time constraints and improve the learning of both. The primary aim of this randomized controlled trial (RCT) is to evaluate the impact of a cross-curricular nutrition and mathematics program on primary school students' portion size estimation skills. Secondary aims include impact on their nutrition knowledge, attitudes towards mathematics and evaluating the quality of the lessons.
METHODS
Twelve Year 3-4 classes from Catholic schools in New South Wales, Australia will be randomised to intervention (n = 6) or control (n = 6) groups. Teachers in the intervention group will receive a professional development workshop and resources to teach 4-5 lessons on portion size and measurements across 1-4 weeks. Outcome measures include portion size estimation skills, nutrition knowledge and attitudes towards mathematics, with data collected during three school visits (pre-intervention, immediately post-intervention, 4 weeks post-intervention). Additionally, teaching quality will be assessed in both intervention and control groups and process evaluation undertaken using teacher interviews and student focus groups.
DISCUSSION
This RCT uses an innovative approach to improve both nutrition and mathematics related learning outcomes among primary school children. It has the potential to impact teaching practices regarding integration of nutrition into curricula and enhance the implementation of nutrition education interventions.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Register ACTRN12619001071112 31/07/2019.",2020,"Outcome measures include portion size estimation skills, nutrition knowledge and attitudes towards mathematics, with data collected during three school visits (pre-intervention, immediately post-intervention, 4 weeks post-intervention).","['Australian and New Zealand', 'Australian primary schools', 'primary school children', '3-4 classes from Catholic schools in New South Wales, Australia', ""primary school students' portion size estimation skills"", 'Twelve Year']","['professional development workshop and resources to teach 4-5 lessons', 'cross-curricular nutrition and mathematics program']","['portion size estimation skills, nutrition knowledge and attitudes towards mathematics, with data collected during three school visits', 'nutrition knowledge, attitudes towards mathematics and evaluating the quality of the lessons']","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0242211', 'cui_str': 'Roman Catholic, follower of religion'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3658326', 'cui_str': 'Portion Size'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0892938,"Outcome measures include portion size estimation skills, nutrition knowledge and attitudes towards mathematics, with data collected during three school visits (pre-intervention, immediately post-intervention, 4 weeks post-intervention).","[{'ForeName': 'Berit M', 'Initials': 'BM', 'LastName': 'Follong', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Prieto-Rodriguez', 'Affiliation': 'School of Education, Faculty of Education and Arts, The University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Miller', 'Affiliation': 'School of Education, Faculty of Education and Arts, The University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Clare E', 'Initials': 'CE', 'LastName': 'Collins', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medicine, The University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Bucher', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, The University of Newcastle, Newcastle, NSW, Australia. tamara.bucher@newcastle.edu.au.'}]",Nutrition journal,['10.1186/s12937-020-00640-x']
2776,33242444,"Bortezomib, thalidomide, and dexamethasone with or without daratumumab for transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA): health-related quality of life outcomes of a randomised, open-label, phase 3 trial.","BACKGROUND
In part 1 of the two-part CASSIOPEIA study, treatment before and after autologous haematopoietic stem-cell transplantation (HSCT) with daratumumab plus bortezomib, thalidomide, and dexamethasone (D-VTd) significantly improved rates of stringent complete response and progression-free survival versus bortezomib, thalidomide, and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma.
METHODS
CASSIOPEIA is an ongoing randomised, open-label, active-controlled, parallel-group, phase 3 trial done at 111 academic and community practice centres in Europe. Transplantation-eligible adults with newly diagnosed multiple myeloma were randomly assigned (1:1) to D-VTd or VTd. Treatment consisted of four 28-day cycles of induction therapy before autologous HSCT and two 28-day cycles of consolidation therapy after. In this prespecified secondary analysis, patient-reported outcomes were assessed using the European Organization for Research and Treatment of Cancer quality of life questionnaire-core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire at baseline, after induction (cycle 4, day 28), and after consolidation (day 100 after autologous HSCT). The analysis was done in all patients in the intention-to-treat population with a baseline and at least one post-baseline patient-reported outcome assessment. The trial is registered at ClinicalTrials.gov (NCT02541383).
FINDINGS
Between Sept 22, 2015, and Aug 1, 2017, 1085 patients were enrolled and randomly assigned D-VTd (n=543) or VTd (n=542). Questionnaire completion rates were high at baseline (511 [94%] of 543 in the D-VTd group vs 510 [94%] of 542 in the VTd group). Compliance rates (calculated from the number of completed surveys as a proportion of the predicted number of participants still on study treatment) were high at post-induction (431 [84%] of 513 vs 405 [80%] of 509) and post-consolidation (414 [90%] of 460 vs 386 [88%] of 438) assessments and were similar between treatment groups. Mean changes in global health status scores from baseline to post-induction were not different between the D-VTd group (3·8 [95% CI 1·6 to 6·0]) and VTd group (2·9 [0·7 to 5·1]; p=0·43), or from baseline to post-consolidation between the two groups (D-VTd group, 9·7 (95% CI 7·4 to 11·9) vs VTd group, 8·7 (6·5 to 11·0; p=0·45). Improvements from baseline in EORTC QLQ-C30 global health status and EQ-5D-5L visual analogue scale scores were observed in post-consolidation scores in both groups. Post-consolidation scores showed significantly greater mean decreases in pain (-23·3 [95% CI -26·6 to -20·0] in the D-VTd group vs -19·7 [-23·0 to -16·3] in the VTd group; p=0·042), significantly smaller reductions in cognitive functioning (-5·0 [-7·6 to -2·4] vs -7·9 [-10·6 to -5·3]; p=0·036), and significantly greater improvements in emotional functioning (13·0 [10·4 to 15·5] vs 9·5 [6·9 to 12·1]; p=0·013) and in constipation (-3·2 [-7·3 to 0·9] vs 1·8 [-2·4 to 6·0]; p=0·025) with D-VTd versus VTd. Between-group differences in change from baseline for all other scales were not significant.
INTERPRETATION
D-VTd and VTd were associated with on-treatment health-related quality of life improvements from baseline in transplantation-eligible patients with newly diagnosed multiple myeloma. The significantly greater reductions in pain, less deterioration of cognitive functioning, and greater emotional functioning improvements complement the clinical benefits observed with D-VTd versus VTd, and support the addition of daratumumab to standard regimens in patients with newly diagnosed multiple myeloma.
FUNDING
Intergroupe Francophone du Myélome, The Dutch-Belgian Cooperative Trial Group for Hematology Oncology, and Janssen Research and Development.",2020,"Mean changes in global health status scores from baseline to post-induction were not different between the D-VTd group (3·8 [95% CI 1·6 to 6·0]) and VTd group (2·9 [0·7 to 5·1]; p=0·43), or from baseline to post-consolidation between the two groups (D-VTd group, 9·7","['Transplantation-eligible adults with newly diagnosed multiple myeloma', 'VTd group', 'transplantation-eligible patients with newly diagnosed multiple myeloma', 'Between Sept 22, 2015, and Aug 1, 2017, 1085 patients were enrolled and randomly assigned D-VTd (n=543) or VTd (n=542', '111 academic and community practice centres in Europe', 'transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA', 'patients with newly diagnosed multiple myeloma']","['D-VTd versus VTd', 'bortezomib, thalidomide, and dexamethasone (VTd', 'D-VTd or VTd', '7·3 to 0·9', 'autologous haematopoietic stem-cell transplantation (HSCT) with daratumumab plus bortezomib, thalidomide, and dexamethasone (D-VTd', 'Bortezomib, thalidomide, and dexamethasone with or without daratumumab']","['global health status scores', 'EORTC QLQ-C30 global health status and EQ-5D-5L visual analogue scale scores', 'emotional functioning (13·0', 'pain (-23·3', 'constipation (-3·2', 'Questionnaire completion rates', 'cognitive functioning', 'Compliance rates', 'European Organization for Research and Treatment of Cancer quality of life questionnaire-core 30-item (EORTC QLQ-C30) and EuroQol 5-dimensional descriptive system (EQ-5D-5L) questionnaire', 'pain']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",1085.0,0.251775,"Mean changes in global health status scores from baseline to post-induction were not different between the D-VTd group (3·8 [95% CI 1·6 to 6·0]) and VTd group (2·9 [0·7 to 5·1]; p=0·43), or from baseline to post-consolidation between the two groups (D-VTd group, 9·7","[{'ForeName': 'Murielle', 'Initials': 'M', 'LastName': 'Roussel', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hebraud', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Laribi', 'Affiliation': 'Centre Hospitalier, Le Mans, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'Centre Hospitalier Universitaire de Limoges, Limoges, France.'}, {'ForeName': 'Mamoun', 'Initials': 'M', 'LastName': 'Dib', 'Affiliation': 'Centre Hospitalier Régional Universitaire-Hôpital du Bocage, Angers, France.'}, {'ForeName': 'Borhane', 'Initials': 'B', 'LastName': 'Slama', 'Affiliation': 'Centre Hospitalier H Duffaut, Avignon, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dorvaux', 'Affiliation': 'Hôpital de Mercy (Centre Hospitalier Régional Metz-Thionville), Metz, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Royer', 'Affiliation': 'Hôpital St-Louis, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Frenzel', 'Affiliation': 'Hôpital Necker, Paris, France.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Zweegman', 'Affiliation': 'Amsterdam Universitair Medische Centra, Vrije Universiteit Amsterdam, Department of Hematology, Amsterdam, Netherlands.'}, {'ForeName': 'Saskia K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Meander Medical Centre, Amersfoort, Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Broijl', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Kon-Siong', 'Initials': 'KS', 'LastName': 'Jie', 'Affiliation': 'Zuyderland MC, Sittard, Netherlands.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Vanquickelberghe', 'Affiliation': 'Janssen Research and Development, Beerse, Belgium.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'de Boer', 'Affiliation': 'Janssen Research and Development, Leiden, Netherlands.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kampfenkel', 'Affiliation': 'Janssen Research and Development, Leiden, Netherlands.'}, {'ForeName': 'Katharine S', 'Initials': 'KS', 'LastName': 'Gries', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fastenau', 'Affiliation': 'Janssen Global Services, Raritan, NJ, USA.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, Netherlands. Electronic address: p.sonneveld@erasmusmc.nl.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30356-2']
2777,33242443,"Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GIMEMA-MMY-3006): long-term follow-up analysis of a randomised phase 3, open-label study.","BACKGROUND
The phase 3 GIMEMA-MMY-3006 trial, which compared bortezomib, thalidomide, and dexamethasone (VTD) combination therapy with thalidomide and dexamethasone (TD) as induction therapy before and consolidation therapy after double autologous haematopoietic stem-cell transplantation (HSCT) for newly diagnosed multiple myeloma, showed the superiority of the triplet regimen over the doublet in terms of increased complete response rate and improved progression-free survival. We report the results from the final analysis of the study.
METHODS
In this randomised, open-label, phase 3 study, patients aged 18-65 years with previously untreated symptomatic multiple myeloma and a Karnofsky Performance Status of 60% or higher were enrolled at 73 centres in Italy. Patients were randomised (1:1) by a web-based system to receive three 21-day cycles of thalidomide (100 mg daily orally for the first 14 days and 200 mg daily thereafter) plus dexamethasone (total 320 mg per cycle; 40 mg on days 1-2, 4-5, 8-9, and 11-12 in the VTD regimen, and 40 mg on days 1-4 and 9-12 in the TD regimen), either alone (TD group) or with bortezomib (1·3 mg/m 2 intravenously on days 1, 4, 8, and 11; VTD group). After double autologous HSCT, patients received two 35-day cycles of either the VTD or TD regimen, according to random assignment, as consolidation therapy. The primary outcome was the rate of complete response and near complete response after induction (already reported). In this updated analysis we assessed long-term progression-free survival and overall survival (secondary endpoints of the study) with an extended 10-year median follow-up, and analysed the variables influencing survival. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, NCT01134484.
FINDINGS
Between May 10, 2006, and April 30, 2008, 480 patients were enrolled and randomly assigned to receive VTD (241 patients) or TD (239 patients). Six patients withdrew consent before start of treatment. 236 (99 [42%] women) in the VTD group and 238 (102 [43%] women) in the TD group were included in the intention-to-treat analysis. The data cutoff date for this analysis was May 31, 2018. Median follow-up for surviving patients was 124·1 months (IQR 117·2-131·7). The 10-year progression-free survival estimate for patients in the VTD group was 34% (95% CI 28-41) compared with 17% (13-23) for the TD group (hazard ratio [HR] 0·62 [95% CI 0·50-0·77]; p<0·0001). 60% (95% CI 54-67) of patients in the VTD group were alive at 10 years versus 46% (40-54) of patients in the TD group (HR 0·68 [95% CI 0·51-0·90]; p=0·0068). VTD was an independent predictor of improved progression-free survival (HR 0·60 [95% CI 0·48-0·76]; p<0·0001) and overall survival (HR 0·68 [0·50-0·91]; p=0·010). The incidence of second primary malignancies per 100 person-years was 0·87 (95% CI 0·49-1·44) in the VTD group compared with 1·41 (0·88-2·13) in the TD group.
INTERPRETATION
Incorporation of VTD into double autologous HSCT resulted in clinically meaningful improvements in long-term progression-free survival and overall survival, confirming that a regimen including bortezomib and an immunomodulatory drug is the gold standard treatment for patients with newly diagnosed myeloma who are fit for high-dose chemotherapy.
FUNDING
Seràgnoli Institute of Haematology, University of Bologna, and BolognAIL.",2020,"INTERPRETATION
Incorporation of VTD into double autologous HSCT resulted in clinically meaningful improvements in long-term progression-free survival and overall survival, confirming that a regimen including bortezomib and an immunomodulatory drug is the gold standard treatment for patients with newly diagnosed myeloma who are fit for high-dose chemotherapy.
","['241 patients) or TD (239 patients', 'patients aged 18-65 years with previously untreated symptomatic multiple myeloma and a Karnofsky Performance Status of 60% or higher were enrolled at 73 centres in Italy', 'Between May 10, 2006, and April 30, 2008, 480 patients', 'patients with newly diagnosed myeloma who are fit for high-dose chemotherapy']","['Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation', 'bortezomib, thalidomide, and dexamethasone (VTD) combination therapy with thalidomide and dexamethasone (TD', 'VTD', 'alone (TD group) or with bortezomib', 'thalidomide', 'bortezomib', 'dexamethasone']","['rate of complete response and near complete response', '10-year progression-free survival estimate', 'long-term progression-free survival and overall survival', 'progression-free survival ', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",480.0,0.505033,"INTERPRETATION
Incorporation of VTD into double autologous HSCT resulted in clinically meaningful improvements in long-term progression-free survival and overall survival, confirming that a regimen including bortezomib and an immunomodulatory drug is the gold standard treatment for patients with newly diagnosed myeloma who are fit for high-dose chemotherapy.
","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Tacchetti', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Pantani', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Patriarca', 'Affiliation': 'Clinical Hematology and Bone Marrow Transplant Centre, S Maria della Misericordia University Hospital, DAME, University of Udine, Udine, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology Unit, and Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zamagni', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dozza', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Galli', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Raimondo', 'Affiliation': 'Division of Hematology, Azienda Ospedaliero-Universitaria Policlinico, Department of Surgery and Medical Specialties, University of Catania, Catania, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Crippa', 'Affiliation': 'Unità Operativa Complessa di Ematologia, Spedali Civili Brescia, Brescia, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Cittàdella Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Barbato', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Tosi', 'Affiliation': 'Unità Operativa, Ematologia, Ospedale Infermi di Rimini, Rimini, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Narni', 'Affiliation': 'Programma Trapianti Cellule Staminali Emopoietiche, Università di Modena e Reggio Emilia, Azienda Ospedaliero-Universitaria, Policlinico di Modena, Modena, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Montefusco', 'Affiliation': 'Department of Hematology, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Testoni', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Spadano', 'Affiliation': 'Unità Operativa Complessa, Ematologia Clinica, Azienda Sanitaria Locale di Pescara, Pescara, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Terragna', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pescosta', 'Affiliation': 'Reparto di Ematologia e Centro Trapianto Midollo Osseo, Ospedale Centrale, Bolzano, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Marzocchi', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cellini', 'Affiliation': 'Unità Operativa Complessa Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Galieni', 'Affiliation': 'Unità Operativa Complessa Ematologia e Terapia cellulare, Ospedale Costanzo e Giacomo Mazzoni, Ascoli Piceno, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ronconi', 'Affiliation': 'IRCCS, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gobbi', 'Affiliation': 'Dipartimento di Medicina interna, Clinica Ematologica, Policlinico Ospedale San Martino, Genoa, Italy.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Catalano', 'Affiliation': 'Unità Operativa Ematologia, Azienda Ospedaliero-Universitaria Federico II, Napoli, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lazzaro', 'Affiliation': 'Division of Hematology and Bone Marrow Transplant Center, Department of Oncology-Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'De Sabbata', 'Affiliation': 'Struttura Complessa Ematologia, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy.'}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Cangialosi', 'Affiliation': 'Divisione di Ematologia ad indirizzo oncologico con Trapianto, Azienda Ospedali Riuniti ""Villa Sofia Cervello"", Presidio Ospedaliero ""V Cervello"", Palermo, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Ciambelli', 'Affiliation': 'Struttura Complessa di Ematologia, Azienda Socio Sanitaria Territoriale della Valle Olona, Busto Arsizio, Italy.'}, {'ForeName': 'Pellegrino', 'Initials': 'P', 'LastName': 'Musto', 'Affiliation': '""Aldo Moro"" University School of Medicine, Unit of Hematology and Stem Cell Transplantation, AOUCPoliclinico, Bari, Italy; Unit of Hematology and Stem Cell Transplantation, Istituto di Ricovero e Cura a Carattere Scientifico Centro di Riferimento Oncologico della Basilicata, Rionero in Vulture, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Elice', 'Affiliation': 'Department of Cell Therapy and Hematology, San Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Istituto di Ematologia ""Seràgnoli"", Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Azienda Ospedaliero-Universitaria di Bologna, Università di Bologna, Bologna, Italy. Electronic address: michele.cavo@unibo.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30323-9']
2778,33243291,A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial.,"BACKGROUND
Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs.
METHODS
Residents of Rhode Island aged 18-65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses.
DISCUSSION
If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04372238 . Registered on 01 May 2020.",2020,"Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization.","['people who use drugs', 'Residents of Rhode Island aged 18-65\u2009years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n\u2009=\u2009500']","['MI booster sessions (intervention) or attention-matched control sessions', 'RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control', 'naloxone', 'naloxone and rescue breathing', 'theory-based fentanyl overdose education and fentanyl test strip distribution intervention', 'behavior change intervention', 'RAPIDS intervention']","['composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit', 'administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses', 'rates of opioid overdose']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0085163', 'cui_str': 'Cocaine freebase'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1828121', 'cui_str': 'Injections'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C1553116', 'cui_str': 'Test strip'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0572088', 'cui_str': 'Fentanyl overdose'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C4505300', 'cui_str': 'Semantic Network'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0580205', 'cui_str': 'Postmortem period'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]",,0.0802047,"Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization.","[{'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Jacka', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Jacqueline E', 'Initials': 'JE', 'LastName': 'Goldman', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Yedinak', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Bernstein', 'Affiliation': 'Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Hadland', 'Affiliation': 'Grayken Center for Addiction, Boston Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Buxton', 'Affiliation': 'School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Sherman', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Katie B', 'Initials': 'KB', 'LastName': 'Biello', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA. brandon_marshall@brown.edu.'}]",Trials,['10.1186/s13063-020-04898-8']
2779,33243300,"StudiCare mindfulness-study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and ""on demand"" guidance.","BACKGROUND
College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with ""on demand"" and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of ""how"" and ""for whom"" such interventions work.
METHODS
In this three-armed randomized controlled trial, both an unguided and ""guidance on demand"" (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles.
DISCUSSION
Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content.
TRIAL REGISTRATION
WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774 . Registered on 18 May 2018.",2020,"The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with ""on demand"" and no guidance.","['387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails', 'college students', 'college students with ""on demand"" and no guidance', 'college students with no and ""on demand"" guidance']","['internet- and mobile-based intervention', 'IMI StudiCare Mindfulness (StudiCare-M', 'unguided and ""guidance']","['sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia', 'stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0002020', 'cui_str': 'Alexithymia'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3850156', 'cui_str': 'Interoception'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0673565,"The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with ""on demand"" and no guidance.","[{'ForeName': 'Ann-Marie', 'Initials': 'AM', 'LastName': 'Küchler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute for Psychology and Education, Ulm University, Albert-Einstein-Allee 47, 89081, Ulm, Germany. ann-marie.kuechler@uni-ulm.de.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Schultchen', 'Affiliation': 'Department of Clinical and Health Psychology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pollatos', 'Affiliation': 'Department of Clinical and Health Psychology, Ulm University, Ulm, Germany.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Moshagen', 'Affiliation': 'Department of Quantitative Methods in Psychology, Ulm University, Ulm, Germany.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute for Psychology and Education, Ulm University, Albert-Einstein-Allee 47, 89081, Ulm, Germany.'}]",Trials,['10.1186/s13063-020-04868-0']
2780,33244045,"Comprehensive corrective exercise program improves alignment, muscle activation and movement pattern of men with upper crossed syndrome: randomized controlled trial.","Upper crossed syndrome (UCS) refers to the altered muscle activations and movement patterns in scapulae along with some abnormal alignment in the upper quarter, which may contribute to the dysfunction of the cervicothoracic and glenohumeral joints. The present study aimed to investigate the effectiveness of a comprehensive corrective exercise program (CCEP) and subsequent detraining on alignment, muscle activation, and movement pattern in men with the UCS. This randomized controlled trial included 24 men. The intervention group conducted CCEP (8 weeks), followed by four weeks of detraining and the control group maintained normal daily activities. Electromyography of selected muscles, scapular dyskinesis test, head, shoulder, and thoracic spine angle were measured at baseline, post-test, and follow-up. There were significant differences for Group x time interaction and also for within-group from pre-test to post-test and follow-up in all outcomes. Also, significant differences were observed in three outcomes at post-test and follow-up between the CCEP and control group in favor of the CCEP. In Conclusion, the present study demonstrates that the CCEP for individuals with UCS is feasible and effective, improving muscle activation imbalance, movement patterns, and alignment. Importantly, these improvements were maintained after four weeks of detraining, suggesting lasting neuromuscular re-training adaptations.",2020,There were significant differences for Group x time interaction and also for within-group from pre-test to post-test and follow-up in all outcomes.,"['men with upper crossed syndrome', '24 men', 'men with the UCS']","['comprehensive corrective exercise program (CCEP) and subsequent detraining', 'CCEP', 'Comprehensive corrective exercise program']","['Electromyography of selected muscles, scapular dyskinesis test, head, shoulder, and thoracic spine angle']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0268496', 'cui_str': 'Oculocerebral syndrome with hypopigmentation'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C4523804', 'cui_str': 'Scapular dyskinesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0581269', 'cui_str': 'Thoracic spine structure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}]",24.0,0.0330708,There were significant differences for Group x time interaction and also for within-group from pre-test to post-test and follow-up in all outcomes.,"[{'ForeName': 'Foad', 'Initials': 'F', 'LastName': 'Seidi', 'Affiliation': 'Health and Sports Medicine Department, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Bayattork', 'Affiliation': 'Health and Sports Medicine Department, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran. Bayattork@ut.ac.ir.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Minoonejad', 'Affiliation': 'Health and Sports Medicine Department, Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Lars Louis', 'Initials': 'LL', 'LastName': 'Andersen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Page', 'Affiliation': 'Franciscan University DPT Program, Baton Rouge, LA, USA.'}]",Scientific reports,['10.1038/s41598-020-77571-4']
2781,33244081,Facial expressions contribute more than body movements to conversational outcomes in avatar-mediated virtual environments.,"This study focuses on the individual and joint contributions of two nonverbal channels (i.e., face and upper body) in avatar mediated-virtual environments. 140 dyads were randomly assigned to communicate with each other via platforms that differentially activated or deactivated facial and bodily nonverbal cues. The availability of facial expressions had a positive effect on interpersonal outcomes. More specifically, dyads that were able to see their partner's facial movements mapped onto their avatars liked each other more, formed more accurate impressions about their partners, and described their interaction experiences more positively compared to those unable to see facial movements. However, the latter was only true when their partner's bodily gestures were also available and not when only facial movements were available. Dyads showed greater nonverbal synchrony when they could see their partner's bodily and facial movements. This study also employed machine learning to explore whether nonverbal cues could predict interpersonal attraction. These classifiers predicted high and low interpersonal attraction at an accuracy rate of 65%. These findings highlight the relative significance of facial cues compared to bodily cues on interpersonal outcomes in virtual environments and lend insight into the potential of automatically tracked nonverbal cues to predict interpersonal attitudes.",2020,140 dyads were randomly assigned to communicate with each other via platforms that differentially activated or deactivated facial and bodily nonverbal cues.,['140 dyads'],['communicate with each other via platforms that differentially activated or deactivated facial and bodily nonverbal cues'],"['nonverbal synchrony', 'interpersonal outcomes']","[{'cui': 'C4319553', 'cui_str': '140'}]","[{'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}]",140.0,0.0272887,140 dyads were randomly assigned to communicate with each other via platforms that differentially activated or deactivated facial and bodily nonverbal cues.,"[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Oh Kruzic', 'Affiliation': 'Virtual Human Interaction Lab, Department of Communication, Stanford University, 450 Serra Mall, Stanford, CA, 94305, USA. catherineoh@stanford.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kruzic', 'Affiliation': 'Virtual Human Interaction Lab, Department of Communication, Stanford University, 450 Serra Mall, Stanford, CA, 94305, USA.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Herrera', 'Affiliation': 'Virtual Human Interaction Lab, Department of Communication, Stanford University, 450 Serra Mall, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bailenson', 'Affiliation': 'Virtual Human Interaction Lab, Department of Communication, Stanford University, 450 Serra Mall, Stanford, CA, 94305, USA.'}]",Scientific reports,['10.1038/s41598-020-76672-4']
2782,33244125,Pedagogical questions promote causal learning in preschoolers.,"What maximizes instructional impact in early childhood? We propose a simple intervention employing ""Pedagogical Questions"". We explore whether swapping some instructional language with questions in psychosomatic storybooks improves preschoolers' memory, learning, and generalization. Seventy-two preschoolers were randomly assigned to one of three conditions and were read storybooks employing either Direct Instruction, Pedagogical Questions, or Control content. Posttest measures of psychosomatic understanding, judgments about the possibility of psychosomatic events, and memory for storybook details showed that children in the Pedagogical Questions condition demonstrated greater memory for relevant storybook details and improved psychosomatic understanding. Our results suggest that pedagogical questions are a relatively simple educational manipulation to improve memory, learning, and transfer of theory-rich content.",2020,"Seventy-two preschoolers were randomly assigned to one of three conditions and were read storybooks employing either Direct Instruction, Pedagogical Questions, or Control content.","['preschoolers', 'Seventy-two preschoolers']","['read storybooks employing either Direct Instruction, Pedagogical Questions, or Control content']","[""preschoolers' memory, learning, and generalization"", 'psychosomatic understanding, judgments about the possibility of psychosomatic events, and memory for storybook details']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C4319632', 'cui_str': '72'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0017324', 'cui_str': 'Generalization (Psychology)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",72.0,0.0151251,"Seventy-two preschoolers were randomly assigned to one of three conditions and were read storybooks employing either Direct Instruction, Pedagogical Questions, or Control content.","[{'ForeName': 'Emily N', 'Initials': 'EN', 'LastName': 'Daubert', 'Affiliation': 'Rutgers University, Newark, USA. edaubert@hawaii.edu.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'National Institute of Education, Singapore, Singapore.'}, {'ForeName': 'Milagros', 'Initials': 'M', 'LastName': 'Grados', 'Affiliation': 'Rutgers University, Newark, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Shafto', 'Affiliation': 'Rutgers University, Newark, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bonawitz', 'Affiliation': 'Rutgers University, Newark, USA.'}]",Scientific reports,['10.1038/s41598-020-77883-5']
2783,33246428,Phase II randomized trial of capecitabine with bevacizumab and external beam radiation therapy as preoperative treatment for patients with resectable locally advanced rectal adenocarcinoma: long term results.,"BACKGROUND
Preoperative chemoradiotherapy with capecitabine is considered as a standard of care for locally advanced rectal cancer. The ""Tratamiento de Tumores Digestivos"" group (TTD) previously reported in a randomized Ph II study that the addition of Bevacizumab to capecitabine-RT conferred no differences in the pre-defined efficacy endpoint (pathological complete response). We present the follow-up results of progression-free survival, distant relapse-free survival, and overall survival data at 3 and 5 years.
METHODS
Patients (pts) were randomized to receive 5 weeks of radiotherapy (45 Gy/25 fractions) with concurrent Capecitabine 825 mg/m2 twice daily, 5 days per week with (arm A) or without (arm b) bevacizumab (5 mg/kg once every 2 weeks).
RESULTS
In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting shows no differences in pathological complete response (15.9% vs 10.9%), distant relapse-free survival (81.0 vs 80.4 and 76.2% vs 78.2% at 3 and 5 years respectively), disease-free survival (75% vs 71.7 and 68.1% vs 69.57% at 3 and 5 years respectively) nor overall survival at 5-years of follow-up (81.8% vs 86.9%).
CONCLUSIONS
the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term.
TRIAL REGISTRATION
EudraCT number: 2009-010192-24 . Clinicaltrials.gov number: NCT01043484 .",2020,"CONCLUSIONS
the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term.
","['Patients (pts', 'patients with resectable locally advanced rectal adenocarcinoma', 'locally advanced rectal cancer']","['Capecitabine 825', 'capecitabine with bevacizumab and external beam radiation therapy', 'radiotherapy', 'bevacizumab', 'bevacizumab to capecitabine and radiotherapy', 'capecitabine', 'Bevacizumab to capecitabine-RT', 'bevacizumab to capecitabine plus radiotherapy']","['distant relapse-free survival', 'disease-free survival', 'pathological complete response', 'progression-free survival, distant relapse-free survival, and overall survival data', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.320648,"CONCLUSIONS
the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term.
","[{'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Salazar', 'Affiliation': ""Medical Oncology. Oncobell Program IDIBELL Institut Català d'Oncologia Hospital Duran i Reynals, CIBERONC, Barcelona, Spain. ramonsalazar@iconcologia.net.""}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Capdevila', 'Affiliation': ""Medical Oncology, Hospital Universitari Vall d'Hebrón, Barcelona, Spain.""}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Manzano', 'Affiliation': 'Medical Oncology, ICO. Hospital Germans Trias i Pujol, Barcelona, Spain.'}, {'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Pericay', 'Affiliation': 'Medical Oncology, C. S. Parc Taulí, Barcelona, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Martínez-Villacampa', 'Affiliation': ""Medical Oncology. Oncobell Program IDIBELL Institut Català d'Oncologia Hospital Duran i Reynals, CIBERONC, Barcelona, Spain.""}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López', 'Affiliation': 'Hospital Marqués de Valdecilla, Santander, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Losa', 'Affiliation': 'Medical Oncology, Hospital Sant Joan Despí - Moisés Broggi, Barcelona, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Safont', 'Affiliation': 'Medical Oncology, Hospital General Universitario, Valencia, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Gómez-España', 'Affiliation': 'Medical Oncology. IMIBIC, Hospital Reina Sofía, CIBERONC Instituto de Salud Carlos III, University of Córdoba, Córdoba, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Alonso-Orduña', 'Affiliation': 'Medical Oncology. Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Escudero', 'Affiliation': 'Medical Oncology. Hospital C. Universitario Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Gallego', 'Affiliation': 'Medical Oncology. Hospital General Universitario de Elche, Alicante, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'García-Paredes', 'Affiliation': 'Medical Oncology, Hospital Clínico San Carlos, Instituto de Investigación Hospital Clinico San Carlos (IdISSC), CIBERONC, Madrid, Spain.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Palacios', 'Affiliation': 'Radiation Oncology, Hospital Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Biondo', 'Affiliation': 'General and Digestive Surgery. Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Grávalos', 'Affiliation': 'Medical Oncology. Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Aranda', 'Affiliation': 'Medical Oncology. IMIBIC, Hospital Reina Sofía, CIBERONC Instituto de Salud Carlos III, University of Córdoba, Córdoba, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-07661-z']
2784,33246430,Effectiveness of Alberta Family Integrated Care on infant length of stay in level II neonatal intensive care units: a cluster randomized controlled trial.,"BACKGROUND
Parents of infants in neonatal intensive care units (NICUs) are often unintentionally marginalized in pursuit of optimal clinical care. Family Integrated Care (FICare) was developed to support families as part of their infants' care team in level III NICUs. We adapted the model for level II NICUs in Alberta, Canada, and evaluated whether the new Alberta FICare™ model decreased hospital length of stay (LOS) in preterm infants without concomitant increases in readmissions and emergency department visits.
METHODS
In this pragmatic cluster randomized controlled trial conducted between December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to provide Alberta FICare™ (n = 5) or standard care (n = 5). Alberta FICare™ is a psychoeducational intervention with 3 components: Relational Communication, Parent Education, and Parent Support. We enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation. The primary outcome was infant hospital LOS. We used a linear regression model to conduct weighted site-level analysis comparing adjusted mean LOS between groups, accounting for site geographic area (urban/regional) and infant risk factors. Secondary outcomes included proportions of infants with readmissions and emergency department visits to 2 months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge.
RESULTS
We enrolled 654 mothers and 765 infants (543 singletons/111 twin cases). Intention to treat analysis included 353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group. The unadjusted difference between groups in infant hospital LOS (1.96 days) was not statistically significant. Accounting for site geographic area and infant risk factors, infant hospital LOS was 2.55 days shorter (95% CI, - 4.44 to - 0.66) in the Alberta FICare™ group than standard care group, P = .02. Secondary outcomes were not significantly different between groups.
CONCLUSIONS
Alberta FICare™ is effective in reducing preterm infant LOS in level II NICUs, without concomitant increases in readmissions or emergency department visits. A small number of sites in a single jurisdiction and select group infants limit generalizability of findings.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT02879799 , retrospectively registered August 26, 2016.",2020,"Secondary outcomes were not significantly different between groups.
","['December 15, 2015 and July 28, 2018, 10 level II NICUs were randomized to', 'enrolled mothers and their singleton or twin infants born between 32 0/7 and 34 6/7 weeks gestation', '353 infants/308 mothers in the Alberta FICare™ group and 365 infants/306 mothers in the standard care group', '654 mothers and 765 infants (543 singletons/111 twin cases', 'Parents of infants in neonatal intensive care units (NICUs', 'infant length of stay in level II neonatal intensive care units']","['Family Integrated Care (FICare', 'Alberta Family Integrated Care', 'provide Alberta FICare™ (n\xa0=\u20095) or standard care']","['proportions of infants with readmissions and emergency department visits to 2\u2009months corrected age, type of feeding at discharge, and maternal psychosocial distress and parenting self-efficacy at discharge', 'site geographic area and infant risk factors, infant hospital LOS', 'infant hospital LOS', 'preterm infant LOS', 'hospital length of stay (LOS']","[{'cui': 'C0441926', 'cui_str': 'Level II'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0455806', 'cui_str': 'Infant length'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]",654.0,0.17207,"Secondary outcomes were not significantly different between groups.
","[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Benzies', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, T2N 1N4, Canada. benzies@ucalgary.ca.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Aziz', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Vibhuti', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'Faculty of Medicine, University of Toronto, and Mount Sinai Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Faris', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Wanrudee', 'Initials': 'W', 'LastName': 'Isaranuwatchai', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Scotland', 'Affiliation': 'Neonatal Intensive Care Unit, Rockyview General Hospital, Alberta Health Services, Calgary, AB, Canada.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Larocque', 'Affiliation': ""Northern Alberta Neonatal Program, Stollery Children's Hospital, Edmonton, AB, Canada.""}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Mrklas', 'Affiliation': 'Strategic Clinical Networks™, System Innovation and Programs, Alberta Health Services, Calgary, AB, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Naugler', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'H Thomas', 'Initials': 'HT', 'LastName': 'Stelfox', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Chari', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Amuchou Singh', 'Initials': 'AS', 'LastName': 'Soraisham', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Albert Richard', 'Initials': 'AR', 'LastName': 'Akierman', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Phillipos', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Amin', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Hoch', 'Affiliation': 'Department of Public Health Sciences, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Zanoni', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kurilova', 'Affiliation': 'Faculty of Nursing, University of Calgary, Calgary, AB, T2N 1N4, Canada.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Lodha', 'Affiliation': 'Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC pediatrics,['10.1186/s12887-020-02438-6']
2785,33246457,Can we prepare healthcare professionals and students for involvement in stressful healthcare events? A mixed-methods evaluation of a resilience training intervention.,"BACKGROUND
Healthcare professionals are experiencing unprecedented levels of occupational stress and burnout. Higher stress and burnout in health professionals is linked with the delivery of poorer quality, less safe patient care across healthcare settings. In order to understand how we can better support healthcare professionals in the workplace, this study evaluated a tailored resilience coaching intervention comprising a workshop and one-to-one coaching session addressing the intrinsic challenges of healthcare work in health professionals and students.
METHODS
The evaluation used an uncontrolled before-and-after design with four data-collection time points: baseline (T1); after the workshop (T2); after the coaching session (T3) and four-to-six weeks post-baseline (T4). Quantitative outcome measures were Confidence in Coping with Adverse Events ('Confidence'), a Knowledge assessment ('Knowledge') and Resilience. At T4, qualitative interviews were also conducted with a subset of participants exploring participant experiences and perceptions of the intervention.
RESULTS
We recruited 66 participants, retaining 62 (93.9%) at T2, 47 (71.2%) at T3, and 33 (50%) at T4. Compared with baseline, Confidence was significantly higher post-intervention: T2 (unadj. β = 2.43, 95% CI 2.08-2.79, d = 1.55, p < .001), T3 (unadj. β = 2.81, 95% CI 2.42-3.21, d = 1.71, p < .001) and T4 (unadj. β = 2.75, 95% CI 2.31-3.19, d = 1.52, p < .001). Knowledge increased significantly post-intervention (T2 unadj. β = 1.14, 95% CI 0.82-1.46, d = 0.86, p < .001). Compared with baseline, resilience was also higher post-intervention (T3 unadj. β = 2.77, 95% CI 1.82-3.73, d = 0.90, p < .001 and T4 unadj. β = 2.54, 95% CI 1.45-3.62, d = 0.65, p < .001). The qualitative findings identified four themes. The first addressed the 'tension between mandatory and voluntary delivery', suggesting that resilience is a mandatory skillset but it may not be effective to make the training a mandatory requirement. The second, the 'importance of experience and reference points for learning', suggested the intervention was more appropriate for qualified staff than students. The third suggested participants valued the 'peer learning and engagement' they gained in the interactive group workshop. The fourth, 'opportunities to tailor learning', suggested the coaching session was an opportunity to personalise the workshop material.
CONCLUSIONS
We found preliminary evidence that the intervention was well received and effective, but further research using a randomised controlled design will be necessary to confirm this.",2020,"Higher stress and burnout in health professionals is linked with the delivery of poorer quality, less safe patient care across healthcare settings.",[],['resilience training intervention'],"[""Confidence in Coping with Adverse Events ('Confidence'), a Knowledge assessment ('Knowledge') and Resilience""]",[],"[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",66.0,0.129329,"Higher stress and burnout in health professionals is linked with the delivery of poorer quality, less safe patient care across healthcare settings.","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Johnson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS29JT, UK. j.johnson@leeds.ac.uk.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Simms-Ellis', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS29JT, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Janes', 'Affiliation': 'Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, BD96RJ, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mills', 'Affiliation': 'Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, BD96RJ, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Budworth', 'Affiliation': 'Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, BD96RJ, UK.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Atkinson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS29JT, UK.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Harrison', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, LS29JT, UK.'}]",BMC health services research,['10.1186/s12913-020-05948-2']
2786,33247008,3D-printed brace in the treatment of adolescent idiopathic scoliosis: a study protocol of a prospective randomised controlled trial.,"INTRODUCTION
Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine. Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day. Three-dimensional (3D) printing technology is a recent advancement that offers unique opportunities for biomedical applications, and customisation of scoliosis braces might lead to greater patient satisfaction and improved compliance. We present here the design of a randomised controlled trial on the clinical effectiveness of 3D-printed braces versus thoracolumbosacral orthoses (TLSO) for patients with AIS.
METHODS AND ANALYSIS
Patients with AIS (age 10-16 years) with Risser sign 0-II, Cobb angle of main curve of 20°-40°, premenarchal or no more than 1-year postmenarchal (for women), and no history of treatment are eligible, unless they are unable to tolerate the treatment or refuse participation. A total of 88 patients will be randomised into either the 3D group or TLSO group on a 1:1 basis. Participants in the 3D group will choose between a 3D-printed brace and TLSO, according to the Zelen's design of the trial. Primary outcome measures will include the average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve. Secondary outcome measures will include immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events. This study is designed as a single-centre, two-arm, superiority and open-label randomised controlled trial. The sample size is calculated with reference to the preliminary study and based on the sample size calculation formula.
ETHICS AND DISSEMINATION
This study was approved by the Peking University Third Hospital Medicine Science Research Ethics Committee (No: 2019-017-02). Results of the trial will be submitted for publication in a peer-reviewed journal and as conference presentations.
TRIAL REGISTRATION NUMBER
ChiCTR1900027379, pre-results.",2020,Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day.,"['eligible patients with AIS', '88 patients', 'age 10-16 years) with Risser sign 0-II, Cobb angle of main curve of 20°-40', 'patients with AIS', 'adolescent idiopathic scoliosis', 'Patients with AIS']","['TLSO', '3D-printed braces versus thoracolumbosacral orthoses (TLSO', '3D-printed brace']","['immediate in-brace correction of Cobb angle of the primary curve, rate of conversion to surgery and incidence of any adverse events', 'average brace-wear time per day, health-related quality of life and Cobb angle progression of the primary curve']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]","[{'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0006086', 'cui_str': 'Brace'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0006086', 'cui_str': 'Brace'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439511', 'cui_str': 'times/day'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",88.0,0.162449,Brace treatment is effective for eligible patients with AIS and the effectiveness is significantly correlated with the average brace-wear time per day.,"[{'ForeName': 'Youyu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Junyang', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Spinal Surgery, Weihai Wei People's Hospital, Weihai, China.""}, {'ForeName': 'Nanfang', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China xunanfang@foxmail.com.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Chaojun', 'Initials': 'C', 'LastName': 'Du', 'Affiliation': 'Department of Orthotics and Prosthetics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yaoxu', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Orthotics and Prosthetics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Zhongjun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Peking University Third Hospital, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2020-038373']
2787,33247012,"Study protocol and implementation details for a pragmatic, stepped-wedge cluster randomised trial of a digital adherence technology to facilitate tuberculosis treatment completion.","INTRODUCTION
Low-cost digital adherence technologies (DATs) such as 99DOTS have emerged as an alternative to directly observed therapy (DOT), the current standard for tuberculosis (TB) treatment supervision. However, there are limited data to support DAT scale-up. The 'DOT to DAT' trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy.
METHODS AND ANALYSIS
This is a pragmatic, stepped-wedge cluster randomised trial, with hybrid type 2 effectiveness-implementation design. The trial will include all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda. Three sites per month will switch from routine care (DOT) to the intervention (99DOTS-based treatment supervision) beginning in month 2, with the order determined randomly. 99DOTS enables patients to be monitored while self-administering TB medicines. Patients receive daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers. The primary effectiveness outcome is the proportion of patients completing TB treatment. With 18 clusters randomised into six steps and an average cluster size of 15 patients per month, the study will have 89% power to detect a 10% or greater increase in treatment completion between the routine care and intervention periods. Secondary outcomes include more proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention.
ETHICS AND DISSEMINATION
Ethics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco. Findings will be disseminated through peer-reviewed publications, presentations at scientific conferences and presentations to key stakeholders.
TRIAL REGISTRATION NUMBER
PACTR201808609844917.",2020,"The 'DOT to DAT' trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy.
","['Ethics approval was granted by institutional review boards at Makerere University School of Public Health and the University of California San Francisco', 'all adults (estimated N=1890) treated for drug-susceptible pulmonary TB over an 8-month period at 18 TB treatment units in Uganda']","['daily automated short message service (SMS) dosing reminders and confirm dosing by calling toll-free numbers', 'digital adherence technology']","['proportion of patients completing TB treatment', 'proximal effectiveness measures as well as quantitative and qualitative assessments of the reach, adoption and implementation of the intervention']","[{'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0018173', 'cui_str': 'Grants'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036382', 'cui_str': 'Public Health Schools'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.150437,"The 'DOT to DAT' trial aims to evaluate the effectiveness and implementation of a 99DOTS-based TB treatment supervision strategy.
","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Crowder', 'Affiliation': 'Center for Tuberculosis and Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kityamuwesi', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kiwanuka', 'Affiliation': 'School of Public Heatlh, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Lamunu', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Namale', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Lynn Kunihira', 'Initials': 'LK', 'LastName': 'Tinka', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Agnes Sanyu', 'Initials': 'AS', 'LastName': 'Nakate', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ggita', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Turimumahoro', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Babirye', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Oyuku', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Christopher Allen', 'Initials': 'CA', 'LastName': 'Berger', 'Affiliation': 'Center for Tuberculosis and Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Austin', 'Initials': 'A', 'LastName': 'Tucker', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'The Better Lab, Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sammann', 'Affiliation': 'The Better Lab, Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Turyahabwe', 'Initials': 'T', 'LastName': 'Stavia', 'Affiliation': 'National Tuberculosis and Leprosy Program, Republic of Uganda Ministry of Health, Kampala, Uganda.'}, {'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Cattamanchi', 'Affiliation': 'Center for Tuberculosis and Division of Pulmonary and Critical Care Medicine, San Francisco General Hospital, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda axk95@case.edu.'}]",BMJ open,['10.1136/bmjopen-2020-039895']
2788,33242717,Randomized controlled trial of bikram yoga and aerobic exercise for depression in women: Efficacy and stress-based mechanisms.,"BACKGROUND
The current study presents a randomized controlled 8-week trial of Bikram yoga, aerobic exercise, and waitlist for depression. Bikram yoga was chosen specifically for its standardized nature. Further, we examined changes in three stress-related constructs-perceived stress, rumination, and mindfulness-as mediators of antidepressant effects.
METHOD
Fifty-three women (age 18-65; 74% White) with a unipolar depressive disorder were randomly assigned to one of the three conditions. Response was defined as >50% reduction on the Hamilton Rating Scale for Depression (HAM-D). Remission was defined as no longer meeting criteria for depression and a HAM-D ≤ 7. Self-reported perceived stress, rumination, and mindfulness were assessed weekly.
RESULTS
In the intention-to-treat sample (n = 53), response rates were significantly higher in the Bikram yoga (61.1%; χ 2 = 10.48, p = .001) and aerobic exercise (60.0%; χ 2 = 10.44, p = .001) conditions relative to waitlist (6.7%). In the completer sample (n = 42), 73.3% (χ 2 = 11.41, p = .001) of women in yoga and 80.0% (χ 2 = 13.72, p < .001) in exercise achieved response compared to 8.3% in waitlist. Reductions in rumination significantly mediated HAM-D change for both active treatments, and mindful acceptance was a partial mediator in the exercise condition.
LIMITATIONS
The sample was small in size, consisted of women only, and was ethnically homogenous. Inter-rater reliability was not assessed, aerobic exercise was not standardized, and mediators were assessed by self-report.
CONCLUSIONS
Bikram yoga showed descriptively similar efficacy to aerobic exercise and both may work, in part, by helping individuals interrupt negative thinking.",2020,"Reductions in rumination significantly mediated HAM-D change for both active treatments, and mindful acceptance was a partial mediator in the exercise condition.
","['women', 'Fifty-three women (age 18-65; 74% White) with a unipolar depressive disorder']","['Bikram yoga, aerobic exercise', 'bikram yoga and aerobic exercise']","['Self-reported perceived stress, rumination, and mindfulness', 'response rates', 'aerobic exercise', 'Remission', 'Hamilton Rating Scale for Depression (HAM-D']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",53.0,0.127941,"Reductions in rumination significantly mediated HAM-D change for both active treatments, and mindful acceptance was a partial mediator in the exercise condition.
","[{'ForeName': 'Cherie L', 'Initials': 'CL', 'LastName': 'La Rocque', 'Affiliation': ""Queen's University, Department of Psychology, Kingston, ON K7L 4V1, Canada.""}, {'ForeName': 'Raegan', 'Initials': 'R', 'LastName': 'Mazurka', 'Affiliation': ""Queen's University, Department of Psychology, Kingston, ON K7L 4V1, Canada.""}, {'ForeName': 'Troy J R', 'Initials': 'TJR', 'LastName': 'Stuckless', 'Affiliation': 'University of Toronto, Canada.'}, {'ForeName': 'Kyra', 'Initials': 'K', 'LastName': 'Pyke', 'Affiliation': ""Queen's University, Department of Psychology, Kingston, ON K7L 4V1, Canada.""}, {'ForeName': 'Kate L', 'Initials': 'KL', 'LastName': 'Harkness', 'Affiliation': ""Queen's University, Department of Psychology, Kingston, ON K7L 4V1, Canada. Electronic address: harkness@queensu.ca.""}]",Journal of affective disorders,['10.1016/j.jad.2020.10.067']
2789,33242754,A randomized trial of individualized versus standard of care antiemetic therapy for breast cancer patients at high risk for chemotherapy-induced nausea and vomiting.,"PURPOSE
Despite triple antiemetic therapy use for breast cancer patients receiving emetogenic chemotherapy, nausea remains a clinical challenge. We evaluated adding olanzapine (5 mg) to triple therapy on nausea control in patients at high personal risk of chemotherapy-induced nausea and vomiting (CINV).
METHODS
This multi-centre, placebo-controlled, double-blind trial randomized breast cancer patients scheduled to receive neo/adjuvant chemotherapy with anthracycline-cyclophosphamide or platinum-based chemotherapy to olanzapine (5 mg, days 1-4) or placebo. Primary endpoint was frequency of self-reported significant nausea, repeated for all cycles of chemotherapy. Secondary endpoints included: duration of nausea, overall total control of CINV, Health Related Quality of Life (HRQoL) using FLIE questionnaire, use of rescue mediation and treatment-related adverse events.
RESULTS
218 eligible patients were randomised to placebo (105) or olanzapine (113). From days 0-5 following each cycle of chemotherapy, 41.3% (95%CI: 36.1-46.7%) of patients in the placebo group reported significant nausea compared to 27.7% (95%CI: 23.2-32.4%) in the olanzapine group (p = 0.001). Across all cycles of chemotherapy, patients receiving olanzapine experienced a statistically significant improvement in HRQoL (p < 0.001). Grade 1/2 sedation was the most commonly side effect reported at 40.8% in the placebo group vs. 54.1% with olanzapine (p < 0.001).
CONCLUSION
In patients at high personal risk of CINV, the addition of olanzapine 5 mg daily to standard antiemetic therapy significantly improves the control of nausea, HRQoL, with no unexpected toxicities.",2020,"Across all cycles of chemotherapy, patients receiving olanzapine experienced a statistically significant improvement in HRQoL (p < 0.001).","['breast cancer patients receiving', 'patients at high personal risk of chemotherapy-induced nausea and vomiting (CINV', '218 eligible patients', 'breast cancer patients scheduled to receive', 'breast cancer patients at high risk for chemotherapy-induced nausea and vomiting']","['placebo', 'individualized versus standard of care antiemetic therapy', 'emetogenic chemotherapy', 'neo/adjuvant chemotherapy with anthracycline-cyclophosphamide or platinum-based chemotherapy to olanzapine', 'olanzapine']","['duration of nausea, overall total control of CINV, Health Related Quality of Life (HRQoL) using FLIE questionnaire, use of rescue mediation and treatment-related adverse events', 'nausea', 'control of nausea, HRQoL, with no unexpected toxicities', 'frequency of self-reported significant nausea, repeated for all cycles of chemotherapy', 'HRQoL', 'Grade 1/2 sedation', 'nausea control']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]",218.0,0.520525,"Across all cycles of chemotherapy, patients receiving olanzapine experienced a statistically significant improvement in HRQoL (p < 0.001).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clemons', 'Affiliation': 'Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada. Electronic address: mclemons@toh.ca.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dranitsaris', 'Affiliation': 'Consultant Biostatistician, 283 Danforth Ave, Toronto, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sienkiewicz', 'Affiliation': 'Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sehdev', 'Affiliation': 'Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mates', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, ON, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hsu', 'Affiliation': 'Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'McGee', 'Affiliation': 'Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Freedman', 'Affiliation': 'Division of Medical Oncology, Durham Regional Cancer Centre, Oshawa, Ontario, Canada.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Markham Stouffville Hospital, Shakir Rehmatullah Cancer Clinic, Markham, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hutton', 'Affiliation': 'Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vandermeer', 'Affiliation': 'Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hilton', 'Affiliation': 'Department of Medicine and Division of Medical Oncology, The Ottawa Hospital and the University of Ottawa, Ottawa, Ontario, Canada; Cancer Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.11.002']
2790,33242769,The effect of levetiracetam and oxcarbazepine monotherapy on thyroid hormones and bone metabolism in children with epilepsy: A prospective study.,"BACKGROUND
Long-term treatment with certain antiepileptic drugs may lead to thyroid function disturbances or alterations in bone metabolism; the data on the effects of new antiepileptic drugs on this are limited and conflicting, especially in children with epilepsy. Therefore, the aim of this study was to investigate the effects of levetiracetam and oxcarbazepine on thyroid hormone levels and bone metabolism in children with epilepsy.
METHODS
A total of 51 children with new-onset partial epilepsy were selected. They were randomly treated with either levetiracetam (n = 25), or oxcarbazepine (n = 26) monotherapy. Eight of the 51 patients were excluded for failing to take the drug continuously or failing to undergo a regular review. Thus, 43 patients were finally included (levetiracetam: 23 patients, oxcarbazepine: 20 patients). A control group consisting of age- and sex-matched healthy subjects (n = 20) was included for comparison. Serum triiodothyronine, tetraiodothyronine, free triiodothyronine, free thyroxine, thyroid-stimulating hormone, calcium, phosphorus, alkaline phosphatase, osteocalcin, parathyroid hormone, and 25-hydroxyvitamin D levels and bone mineral density values were measured before and at 6 and 12 months after therapy in all groups.
RESULTS
At baseline, thyroid hormone levels, bone metabolism index, and bone mineral density values did not differ between the control group and the drug-treated groups. Levetiracetam-treated patients showed no significant changes in thyroid hormone levels, bone metabolism, and bone mineral density during the 12-month follow-up period compared with baseline values. In the oxcarbazepine group, compared to baseline values, serum free thyroxine levels decreased after 12 months of treatment (Z = -3.115, p = 0.002), and after 6 and 12 months of treatment, calcium levels decreased (Z = -3.705, p < 0.001 and Z = -3.884, p < 0.001, respectively) and parathyroid hormone levels increased (Z = -3.698, p < 0.001 and Z = -3.921, p < 0.001, respectively); however, all other parameters did not differ from baseline values.
CONCLUSION
Our data show that levetiracetam treatment has no significant effect on thyroid function and bone metabolism in children with epilepsy. Long-term use of oxcarbazepine may reduce serum free thyroxine levels, resulting in impaired thyroid function, and may reduce serum calcium and increase parathyroid hormone levels, leading to bone metabolism disorders.",2020,"At baseline, thyroid hormone levels, bone metabolism index, and bone mineral density values did not differ between the control group and the drug-treated groups.","['age- and sex-matched healthy subjects (n\u202f=\u202f20) was included for comparison', '51 children with new-onset partial epilepsy', 'Eight of the 51 patients were excluded for failing to take the drug continuously or failing to undergo a regular review', 'children with epilepsy', '43 patients were finally included (levetiracetam: 23 patients, oxcarbazepine: 20 patients']","['levetiracetam and oxcarbazepine', 'Levetiracetam', 'oxcarbazepine (n\u202f=\u202f26) monotherapy', 'levetiracetam', 'levetiracetam and oxcarbazepine monotherapy', 'oxcarbazepine']","['thyroid hormone levels, bone metabolism, and bone mineral density', 'parathyroid hormone levels', 'thyroid hormone levels, bone metabolism index, and bone mineral density values', 'thyroid hormone levels and bone metabolism', 'Serum triiodothyronine, tetraiodothyronine, free triiodothyronine, free thyroxine, thyroid-stimulating hormone, calcium, phosphorus, alkaline phosphatase, osteocalcin, parathyroid hormone, and 25-hydroxyvitamin D levels and bone mineral density values', 'thyroid function and bone metabolism', 'serum free thyroxine levels', 'calcium levels', 'thyroid hormones and bone metabolism']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0014547', 'cui_str': 'Localization-related epilepsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}]","[{'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}]","[{'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine'}, {'cui': 'C0202225', 'cui_str': 'T4 free measurement'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1269634', 'cui_str': 'Serum free T4 measurement'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement'}]",51.0,0.0464167,"At baseline, thyroid hormone levels, bone metabolism index, and bone mineral density values did not differ between the control group and the drug-treated groups.","[{'ForeName': 'Kai-Li', 'Initials': 'KL', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Guangzhou Women and Children's Medical Center, 9 Jinsui Road, Guangzhou 510623, China; Department of Neurology of Shanxi, Children's Hospital, 13 Xinmin North Street, Xinghualing, Taiyuan 030013, China. Electronic address: kailihappy@126.com.""}, {'ForeName': 'Jun-Xiu', 'Initials': 'JX', 'LastName': 'Guo', 'Affiliation': ""Department of Neurosurgery of Shanxi, Children's Hospital, 13 Xinmin North Street, Xinghualing, Taiyuan 030013, China.""}, {'ForeName': 'Hui-Min', 'Initials': 'HM', 'LastName': 'Zhao', 'Affiliation': ""Shan'xi Medical University, Taiyuan 030000, China.""}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': ""Department of Neurology of Shanxi, Children's Hospital, 13 Xinmin North Street, Xinghualing, Taiyuan 030013, China.""}, {'ForeName': 'Chuan-Zi', 'Initials': 'CZ', 'LastName': 'Yang', 'Affiliation': ""Institute of Pediatrics, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou 510623, China.""}, {'ForeName': 'Yun-Hong', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': ""Department of Neurology of Shanxi, Children's Hospital, 13 Xinmin North Street, Xinghualing, Taiyuan 030013, China. Electronic address: wuyunhong510@163.com.""}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Du', 'Affiliation': ""Department of Neurology of Shanxi, Children's Hospital, 13 Xinmin North Street, Xinghualing, Taiyuan 030013, China.""}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107555']
2791,33242775,MINDSET: Clinic-based decision support demonstrates longitudinal efficacy for increased epilepsy self-management adherence among Spanish speaking patients.,"BACKGROUND
MINDSET, a bilingual (Eng./Span.) decision support tool was found feasible for facilitating goal-based epilepsy self-management (ESM) in the clinic.
PURPOSE
To evaluate the efficacy of MINDSET to increase ESM adherence among Hispanic patients.
METHODS
A RCT was conducted from August 2017 through January 2019. Spanish and English speaking Hispanic adult patients (n=94) with epilepsy in Arizona (n=53) and Texas (n=41) were randomly assigned within 6 neurology clinics to treatment (MINDSET plus Usual Care, hereafter referred to as MINDSET; n=46) and comparison (Usual Care Only; n=48) conditions. Self-reported self-management behavior (assessed through the Epilepsy Self-management scale) were categorized as adherent if performed 'usually' or 'always.' The proportion of adherence was compared between study conditions for 36 individual ESM behaviors and 5 ESM domains using Fischer's exact test.
RESULTS
The average time between visit 1 through 3 was 350+/-79 days with retention at 96.8%. Participants in the treatment condition had more college education and less unemployment. Self-management adherence improved across visits for all self-management behaviors irrespective of study condition. Compared to usual care MINDSET use led to greater ESM adherence for 86.1% behaviors (5 with statistical significance; p<0.05) and to significant improvement in the ESM domain of 'information management' (p<0.05).
CONCLUSIONS
Implementation of MINDSET within regular neurology visits may assist Hispanic adults with epilepsy to increase their adherence to ESM behaviors and maintain this adherence longitudinally. Replication with a broader demographic population of people with epilepsy is indicated.",2020,"Compared to usual care MINDSET use led to greater ESM adherence for 86.1% behaviors (5 with statistical significance; p<0.05) and to significant improvement in the ESM domain of 'information management' (p<0.05).
","['Hispanic patients', 'Spanish speaking patients', 'Hispanic adults with epilepsy', 'Spanish and English speaking Hispanic adult patients (n=94) with epilepsy in Arizona (n=53) and Texas (n=41']",['MINDSET'],"['college education and less unemployment', 'ESM adherence', 'average time', 'Self-reported self-management behavior']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0003787', 'cui_str': 'Arizona - US state'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]",[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",41.0,0.0364922,"Compared to usual care MINDSET use led to greater ESM adherence for 86.1% behaviors (5 with statistical significance; p<0.05) and to significant improvement in the ESM domain of 'information management' (p<0.05).
","[{'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Shegog', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States. Electronic address: Ross.Shegog@uth.tmc.edu.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Begley', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Chong', 'Affiliation': 'University of Arizona, Department of Neurology, Tucson, AZ, United States.'}, {'ForeName': 'Refugio', 'Initials': 'R', 'LastName': 'Sepulveda', 'Affiliation': 'University of Arizona, Department of Neurology, Tucson, AZ, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Addy', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Martin', 'Affiliation': 'Epilepsy Foundation Central & South Texas, San Antonio, TX, United States.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Rosales', 'Affiliation': 'University of Texas School of Public Health, Behavioral Science, Houston, TX, United States.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Halavacs', 'Affiliation': 'Florida Health Dept., Fort Lauderdale, FL, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Labiner', 'Affiliation': 'University of Arizona, Department of Neurology, Tucson, AZ, United States.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107552']
2792,33247380,"Do Zinc Supplements Enhance the Clinical Efficacy of Hydroxychloroquine?: a Randomized, Multicenter Trial.","No specific treatment for COVID-19 infection is available up till now, and there is a great urge for effective treatment to reduce morbidity and mortality during this pandemic. We aimed to evaluate the effect of combining chloroquine/hydroxychloroquine (CQ/HCQ) and zinc in the treatment of COVID-19 patients. This was a randomized clinical trial conducted at three major University hospitals in Egypt. One hundred ninety-one patients with a confirmed diagnosis of COVID-19 infection were randomized into two groups: group I (96) patients received both HCQ and zinc, and group II (95) received HCQ only. The primary endpoints were the recovery within 28 days, the need for mechanical ventilation, and death. The two groups were matched for age and gender. They had no significant difference regarding any of the baseline laboratory parameters or clinical severity grading. Clinical recovery after 28 days was achieved by 79.2% in the zinc group and 77.9% in zinc-free treatment group, without any significant difference (p = 0.969). The need for mechanical ventilation and the overall mortality rates did not show any significant difference between the 2 groups either (p = 0.537 and 0.986, respectively). The age of the patient and the need for mechanical ventilation were the only risk factors associated with the patients' mortality by the univariate regression analysis (p = 0.001 and < 0.001, respectively). Zinc supplements did not enhance the clinical efficacy of HCQ. More randomized studies are needed to evaluate the value of adding zinc to other therapies for COVID 19. ClinicalTrials.gov Identifier: NCT04447534.",2020,"The need for mechanical ventilation and the overall mortality rates did not show any significant difference between the 2 groups either (p = 0.537 and 0.986, respectively).","['COVID-19 patients', 'One hundred ninety-one patients with a confirmed diagnosis of COVID-19 infection', 'three major University hospitals in Egypt']","['chloroquine/hydroxychloroquine (CQ/HCQ', 'Zinc supplements', 'HCQ only', 'Hydroxychloroquine', 'HCQ and zinc']","['recovery within 28\xa0days, the need for mechanical ventilation, and death', 'clinical efficacy of HCQ', 'overall mortality rates', 'Clinical recovery']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}]","[{'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",191.0,0.227374,"The need for mechanical ventilation and the overall mortality rates did not show any significant difference between the 2 groups either (p = 0.537 and 0.986, respectively).","[{'ForeName': 'Sherief', 'Initials': 'S', 'LastName': 'Abd-Elsalam', 'Affiliation': 'Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, El-Giash Street, Tanta, 31527, Egypt. sherif.abdelbaky@med.tanta.edu.eg.'}, {'ForeName': 'Shaimaa', 'Initials': 'S', 'LastName': 'Soliman', 'Affiliation': 'Public health and Community Medicine, Menoufia University, Menoufia, Egypt.'}, {'ForeName': 'Eslam Saber', 'Initials': 'ES', 'LastName': 'Esmail', 'Affiliation': 'Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, El-Giash Street, Tanta, 31527, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Khalaf', 'Affiliation': 'Tropical Medicine and Infectious Diseases Department, Faculty of Medicine, Tanta University, El-Giash Street, Tanta, 31527, Egypt.'}, {'ForeName': 'Ehab F', 'Initials': 'EF', 'LastName': 'Mostafa', 'Affiliation': 'Tropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Medhat', 'Affiliation': 'Tropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ossama Ashraf', 'Initials': 'OA', 'LastName': 'Ahmed', 'Affiliation': 'Internal Medicine Department, Ain-shams University, Cairo, Egypt.'}, {'ForeName': 'Mohamed Samir Abd', 'Initials': 'MSA', 'LastName': 'El Ghafar', 'Affiliation': 'Department of Anesthesia, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Alboraie', 'Affiliation': 'Department of Internal Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Sahar M', 'Initials': 'SM', 'LastName': 'Hassany', 'Affiliation': 'Tropical Medicine and Gastroenterology Department, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]",Biological trace element research,['10.1007/s12011-020-02512-1']
2793,33246252,Comparison of equiosmolar doses of 10% hypertonic saline and 20% mannitol for controlling intracranial hypertention in patients with large hemispheric infarction.,"OBJECTIVE
We conducted this prospective self-crossover controlled trial to compare the efficacy and safety of 10 % hypertonic saline (HS) and 20 % mannitol in doses of similar osmotic burden for the treatment of increased intracranial pressure (ICP) in patients with large hemispheric infarction (LHI).
PATIENTS AND METHODS
Patients with LHI were enrolled from January 2017 to January 2018. We used an alternating treatment protocol to compare the effects of HS with mannitol given for episodes of increased ICP in patients with LHI. Indicators such as ICP, mean arterial pressure (MAP) and cerebral perfusion pressure (CPP) were continuously monitored at regular intervals for 240 min after initiation of infusion. Electrolytes, plasma osmolality and renal functions were measured before and 240 min after initiation of infusion to compare the efficacy and safety of the two drugs.
RESULTS
A total of 49 episodes of increased ICP occurred in 14 patients with LHI, of which 24 were infused with 10 % HS and 25 with 20 % mannitol. Both the treatments were equally effective in reducing ICP (P < 0.01). The differences in the duration and degree of reduction were not significant between the groups (P > 0.05). Although both the osmolar agents decreased MAP, the degree was greater in the mannitol group (P < 0.05) at T120. The increase in CPP was greater in the HS group compared with the mannitol group (P < 0.05) at T120. However, HS was associated with faster heart rate (HR) and higher serum chloride levels (P < 0.05). Changes in serum sodium levels and osmolality were not significant between the groups in spite of being higher in the HS group.
CONCLUSIONS
Both the drugs can serve as first-line agents for treating intracranial hypertension caused by LHI and should be selected rationally according to the differences in efficacy and adverse effects.",2020,The increase in CPP was greater in the HS group compared with the mannitol group (P < 0.05) at T120.,"['patients with LHI', 'patients with large hemispheric infarction (LHI', 'patients with large hemispheric infarction', 'Patients with LHI were enrolled from January 2017 to January 2018']","['mannitol', 'hypertonic saline (HS) and 20 % mannitol', 'HS with mannitol', 'equiosmolar doses of 10% hypertonic saline and 20% mannitol']","['Electrolytes, plasma osmolality and renal functions', 'duration and degree of reduction', 'CPP', 'ICP', 'serum sodium levels and osmolality', 'efficacy and safety', 'ICP, mean arterial pressure (MAP) and cerebral perfusion pressure (CPP', 'intracranial pressure (ICP', 'faster heart rate (HR) and higher serum chloride levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0428713', 'cui_str': 'Cerebral perfusion pressure'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1317978', 'cui_str': 'Serum chloride measurement'}]",24.0,0.0513012,The increase in CPP was greater in the HS group compared with the mannitol group (P < 0.05) at T120.,"[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing 100053, China. Electronic address: suyingying@xwh.ccmu.edu.cn.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Zhongyun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing 100053, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing 100053, China.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106359']
2794,33246270,CT-based radiomics for predicting brain metastases as the first failure in patients with curatively resected locally advanced non-small cell lung cancer.,"PURPOSE
Brain metastasis (BM) is the primary first failure pattern in patients with curatively resected locally advanced non-small cell lung cancer (LA-NSCLC). It is not yet possible to accurately predict the occurrence of BM. The purpose of the research is to develop and validate a prediction model of BM-free survival based on radiomics characterising the primary lesions combined with clinical characteristics in patients with curatively resected LA-NSCLC.
METHODS
This study consisted of 124 patients with curatively resected stage IIB-IIIB NSCLC in our institution between January 2014 and June 2018. Patients were randomly divided into training and validation cohorts using a 4:1 ratio. Radiomics features were selected from the chest CT images before surgery. A radiomics signature was constructed using the LASSO algorithm based on the training cohort. Clinical model was developed using the Cox proportional hazards model. The clinical, radiomics, and integrated nomograms were constructed. The prediction performance of the models was assessed based on its discrimination, calibration, and clinical utility.
RESULTS
The radiomics signature is significantly associated with BM-free survival in the overall cohort. The discrimination performance of the integrated nomogram, with the C-indexes 0.889 (0.872-0.906, 95 % CI) and 0.853 (0.788-0.918, 95 % CI) in the training and validation cohorts, respectively, is significantly better than the clinical nomogram (p < 0.0001 for the training cohort, p = 0.0008 for the validation cohort). Compared with the radiomics nomogram, the integrated nomogram is also improved to varying degrees, but not apparent in the validation cohort (p = 0.0007 for the training cohort, p = 0.0554 for the validation cohort). The calibration curve and decision curve analysis demonstrated that the integrated nomogram exceeded the clinical or radiomics nomograms in predicting BM-free survival.
CONCLUSIONS
Compared with the clinical or radiomics nomograms, the predictive performance of the integrated nomogram is significantly improved. The integrated nomogram is most suitable for predicting BM-free survival in patients with curatively resected LA-NSCLC.",2020,"The discrimination performance of the integrated nomogram, with the C-indexes 0.889 (0.872-0.906, 95 % CI) and 0.853 (0.788-0.918, 95 % CI) in the training and validation cohorts, respectively, is significantly better than the clinical nomogram (p < 0.0001 for the training cohort, p = 0.0008 for the validation cohort).","['patients with curatively resected locally advanced non-small cell lung cancer (LA-NSCLC', '124 patients with curatively resected stage IIB-IIIB NSCLC in our institution between January 2014 and June 2018', 'patients with curatively resected LA-NSCLC', 'patients with curatively resected locally advanced non-small cell lung cancer']",['CT-based radiomics'],['BM-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0441769', 'cui_str': 'Stage 2B'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",124.0,0.033608,"The discrimination performance of the integrated nomogram, with the C-indexes 0.889 (0.872-0.906, 95 % CI) and 0.853 (0.788-0.918, 95 % CI) in the training and validation cohorts, respectively, is significantly better than the clinical nomogram (p < 0.0001 for the training cohort, p = 0.0008 for the validation cohort).","[{'ForeName': 'Fenghao', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'School of Clinical Medicine, Weifang Medical University, Weifang, Shandong, China; Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China. Electronic address: 18366120520@163.com.'}, {'ForeName': 'Yicong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nuclear Medicine, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Department of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Nuclear Medicine, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Department of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China. Electronic address: 251400067@qq.com.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Xing', 'Affiliation': 'School of Clinical Medicine, Weifang Medical University, Weifang, Shandong, China; Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Science, Jinan, Shandong, China; Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China; Department of Graduate, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China. Electronic address: xinglg@medmail.com.cn.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109411']
2795,33246931,Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial.,"PURPOSE
To report updated analyses of the phase III CheckMate 214 trial with extended minimum follow-up assessing long-term outcomes with first-line nivolumab plus ipilimumab (NIVO+IPI) versus (vs) sunitinib (SUN) in patients with advanced renal cell carcinoma (aRCC).
METHODS
Patients with aRCC with a clear cell component were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk and randomised to NIVO (3 mg/kg) plus IPI (1 mg/kg) every three weeks ×4 doses, followed by NIVO (3 mg/kg) every two weeks; or SUN (50 mg) once per day ×4 weeks (6-week cycle). Efficacy endpoints included overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) per independent radiology review committee in patients with intermediate/poor-risk disease (I/P; primary), intent-to-treat patients (ITT; secondary) and in patients with favourable-risk disease (FAV; exploratory).
RESULTS
Overall, 1096 patients were randomised (ITT: NIVO+IPI, n=550, SUN, n=546; I/P: NIVO+IPI, n=425, SUN, n=422; FAV: NIVO+IPI, n=125, SUN, n=124). After 4 years minimum follow-up, OS (HR; 95% CI) remained superior with NIVO+IPI vs SUN in ITT (0.69; 0.59 to 0.81) and I/P patients (0.65; 0.54 to 0.78). Four-year PFS probabilities were 31.0% vs 17.3% (ITT) and 32.7% vs 12.3% (I/P), with NIVO+IPI vs SUN. ORR remained higher with NIVO+IPI vs SUN in ITT (39.1% vs 32.4%) and I/P (41.9% vs 26.8%) patients. In FAV patients, the HRs (95% CI) for OS and PFS were 0.93 (0.62 to 1.40) and 1.84 (1.29 to 2.62); ORR was lower with NIVO+IPI vs SUN. However, more patients in all risk groups achieved complete responses with NIVO+IPI: ITT (10.7% vs 2.6%), I/P (10.4% vs 1.4%) and FAV (12.0% vs 6.5%). Probability (95% CI) of response ≥4 years was higher with NIVO+IPI vs SUN (ITT, 59% (0.51 to 0.66) vs 30% (0.21 to 0.39); I/P, 59% (0.50 to 0.67) vs 24% (0.14 to 0.36); and FAV, 60% (0.41 to 0.75) vs 38% (0.22 to 0.54)) regardless of risk category. Safety remained favourable with NIVO+IPI vs SUN.
CONCLUSION
After long-term follow-up, NIVO+IPI continues to demonstrate durable efficacy benefits vs SUN, with manageable safety.
TRIAL REGISTRATION DETAILS
ClinicalTrials.gov identifier: NCT02231749.",2020,"After 4 years minimum follow-up, OS (HR; 95% CI) remained superior with NIVO+IPI vs SUN in ITT (0.69; 0.59 to 0.81) and I/P patients (0.65; 0.54 to 0.78).","['1096 patients were randomised (ITT: NIVO+IPI, n=550, SUN, n=546; I/P: NIVO+IPI, n=425, SUN, n=422; FAV: NIVO+IPI, n=125, SUN, n=124', 'advanced renal cell carcinoma', 'patients with advanced renal cell carcinoma (aRCC', 'Patients with aRCC with a clear cell component were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk and randomised to']","['Nivolumab plus ipilimumab versus sunitinib', 'extended minimum follow-up assessing long-term outcomes with first-line nivolumab plus ipilimumab (NIVO+IPI) versus (vs) sunitinib (SUN', 'SUN', 'NIVO (3\u2009mg/kg) plus IPI']","['Probability', 'ORR', 'FAV', 'OS and PFS', 'overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) per independent radiology review committee in patients with intermediate/poor-risk disease', 'PFS probabilities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C4721698', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",1096.0,0.100446,"After 4 years minimum follow-up, OS (HR; 95% CI) remained superior with NIVO+IPI vs SUN in ITT (0.69; 0.59 to 0.81) and I/P patients (0.65; 0.54 to 0.78).","[{'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Cancer Medicine, Gustave Roussy, Villejuif, France laurence.albiges@gustaveroussy.fr.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Burotto', 'Affiliation': 'Bradford Hill Clinical Research Center, Santiago, Chile.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McDermott', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology and Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Barthélémy', 'Affiliation': 'Medical Oncology Unit, Hôpitaux Universitaires de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': ""University of Bari 'A. Moro', Bari, Italy.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Department of Urology, Barts Cancer Institute, Royal Free NHS Trust, London, UK.'}, {'ForeName': 'Frede', 'Initials': 'F', 'LastName': 'Donskov', 'Affiliation': 'Department of Oncology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Saby', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York, USA.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Department of Medicine, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gurney', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'Marc-Oliver', 'Initials': 'MO', 'LastName': 'Grimm', 'Affiliation': 'Department of Urology, Jena University Hospital, Jena, Thüringen, Germany.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Niigata University Faculty of Medicine Graduate School of Medical and Dental Sciences, Niigata, Japan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Castellano', 'Affiliation': 'Medical Oncology Service, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Division of Hematology Oncology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Shruti Shally', 'Initials': 'SS', 'LastName': 'Saggi', 'Affiliation': 'Department of Clinical Trials, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Department of Biostatistics, Bristol Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}]",ESMO open,['10.1136/esmoopen-2020-001079']
2796,33247703,The Effects of Text Message and Infographic on Reducing the Number Cigarettes Consumption: A Randomized Controlled Trial.,"OBJECTIVE
To test the effect of a text-message and infographic to promote smokers quit smoking.
Methods: A randomized control trial was conducted in two provinces of northeast Thailand. Three hundred and ninety-six participants were allocated to either a text-message and infographic group or a control group. We assessed the primary outcome by self-reported 7-day point prevalence smoking abstinence. Multiple logistic regression was used to test the effect of quitting smoking.
Results: At 3-month follow-up, lost to follow-up 16 participants, 380 participants were included for analysis. The difference in the rate of quitting smoking between the intervention and control groups was not found a statistical significance (17.8% versus 11.6%). However, we found a statistically significant difference in the number of cigarettes smokes (the difference: -1.74; 95%CI: -2.63, -0.84).
Conclusion: No effect of text message and infographic for help smokers to quit smoking. However, the intervention showed a decrease in the number of cigarettes smoked.",2020,Three hundred and ninety-six participants were allocated to either a text-message and infographic group or a control group.,"['two provinces of northeast Thailand', 'Three hundred and ninety-six participants', 'help smokers to quit smoking', '16 participants, 380 participants were included for analysis', 'smokers quit smoking']","['Methods', 'text-message and infographic', 'Text Message and Infographic', 'Conclusion', 'text-message and infographic group or a control group', 'text message and infographic']","['Number Cigarettes Consumption', 'rate of quitting smoking', 'self-reported 7-day point prevalence smoking abstinence', 'number of cigarettes smokes', 'number of cigarettes smoked']","[{'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C5191354', 'cui_str': '396'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}]",396.0,0.11239,Three hundred and ninety-six participants were allocated to either a text-message and infographic group or a control group.,"[{'ForeName': 'Nirun', 'Initials': 'N', 'LastName': 'Intarut', 'Affiliation': 'Health Systems Science Unit, Faculty of Medicine, Mahasarakham University, Muang, Maha Sarakham, Thailand.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Wongkongdech', 'Affiliation': 'Health Systems Science Unit, Faculty of Medicine, Mahasarakham University, Muang, Maha Sarakham, Thailand.'}, {'ForeName': 'Chollada', 'Initials': 'C', 'LastName': 'Thronsao', 'Affiliation': 'Emergency Medical Operation, Faculty of Medicine, Mahasarakham University, Muang, Maha Sarakham, Thailand.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.11.3413']
2797,33247774,BIO-NAIL: a bacterial cellulose dressing as a new alternative to preserve the nail bed after avulsion.,"Avulsion of the nail plate is the most accomplished surgical procedure among the nail apparatus surgeries. Since it is not possible to use the removed nail to cover the nail bed, some materials have been suggested, however, they are generally not available for use and often at a high cost. To evaluate the use of Bacterial Cellulose (BC) dressing as a biological nail (Bio-Nail) after partial or total avulsion of the nail plate. Twenty-six candidates for nail avulsion, were randomized into two groups: Control, using Vaseline with gauze (11 patients) and Experimental group, BC group, using the Bio-Nail (15 patients). The patients were followed up during the 180-day period. The distribution of the patients in the groups was homogeneous for both sociodemographic and clinical data. The occurrence of infection (1 case in the control group) was not statistically relevant. The BC group had lower pain intensity (p = 0.011) with earlier temporal resolution when compared to the control group (p = 0.003). The BC group presented earlier reepithelization (p = 0.022) and better quantitative (p = 0.021) and qualitative conditions (p = 0.011) for the exudate. Regarding satisfaction, all the patients were satisfied. Good preservation of the nail plate area was observed in the BC group at the end of the 180-day period (p = 0.024). Average time of BC dressing permanence was 16.4 ± 7.1 days. BC showed to be appropriate as a dressing after partial or total avulsion of the nail plate. BC is a Bio-Nail promising for nail bed healing.",2020,The BC group had lower pain intensity (p = 0.011) with earlier temporal resolution when compared to the control group (p = 0.003).,['Twenty-six candidates for nail avulsion'],"['Vaseline with gauze', 'Bacterial Cellulose (BC) dressing']","['occurrence of infection', 'Average time of BC dressing permanence', 'nail plate area', 'earlier reepithelization', 'lower pain intensity']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0191722', 'cui_str': 'Removal of nail'}]","[{'cui': 'C0728774', 'cui_str': 'Vaseline'}, {'cui': 'C0590323', 'cui_str': 'Gauzes'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007648', 'cui_str': 'Cellulose'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0547050', 'cui_str': 'Permanences'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",26.0,0.0183412,The BC group had lower pain intensity (p = 0.011) with earlier temporal resolution when compared to the control group (p = 0.003).,"[{'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Oliveira', 'Affiliation': 'Department of Dermatology, Hospital das Clínicas, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}, {'ForeName': 'F C M', 'Initials': 'FCM', 'LastName': 'Pinto', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil. fcmorone@gmail.com.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Ferraz-Carvalho', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Albuquerque', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Aguiar', 'Affiliation': 'Post-Graduation Program in Surgery, Department of Surgery, Health Sciences Center, Federal University of Pernambuco, UFPE, Pernambuco, Brazil.'}]",Journal of materials science. Materials in medicine,['10.1007/s10856-020-06456-9']
2798,33247817,Short-term effects of a Paleolithic lifestyle intervention in breast cancer patients undergoing radiotherapy: a pilot and feasibility study.,"Evolutionary principles are rarely considered in clinical oncology. We here aimed to test the feasibility and effects of a dietary and physical activity intervention based on evolutionary considerations in an oncological setting. A total of 13 breast cancer patients referred to our clinic for curative radiotherapy were recruited for this pilot study. The women were supposed to undertake a ""Paleolithic lifestyle"" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30 min duration while undergoing radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters were assessed before, during, and at the end of radiotherapy. A control group on an unspecified standard diet (SD) was assigned by propensity score matching. A total of eleven patients completed the study. The majority of patients (64%) reported feeling good or very good during the intervention. The intervention group experienced an average decrease of 0.4 kg body weight (p < 0.001) and 0.34 kg (p < 0.001) fat mass per week, but fat-free and skeletal muscle mass were not significantly affected. Vitamin D levels increased slightly from 23.8 (11-37.3) ng/ml to 25.1 (22.6-41.6) ng/ml (p = 0.053). β-hydroxybutyrate levels were significantly increased and triglycerides and free T3 hormone levels significantly reduced by the PL intervention. This pilot study shows that adoption of a PL intervention during curative radiotherapy of breast cancer patients is feasible and able to reduce fat mass. Daily outdoor activity could eliminate vitamin D deficiency (vitamin D < 20 ng/ml). Future studies are needed to confirm these findings.",2020,β-hydroxybutyrate levels were significantly increased and triglycerides and free T3 hormone levels significantly reduced by the PL intervention.,"['breast cancer patients', '13 breast cancer patients referred to our clinic for curative radiotherapy', 'breast cancer patients undergoing']","['Paleolithic lifestyle intervention', 'Paleolithic lifestyle"" (PL) intervention consisting of a Paleolithic diet and daily outdoor activity of at least 30\xa0min duration while undergoing radiotherapy', 'radiotherapy', 'dietary and physical activity intervention', 'PL intervention', 'unspecified standard diet (SD']","['Vitamin D levels', 'triglycerides and free\xa0T3 hormone levels', 'Body composition', 'β-hydroxybutyrate levels', 'fat-free and skeletal muscle mass', 'Blood parameters']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0452423', 'cui_str': 'Stone age diet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0519160', 'cui_str': 'Triiodothyronine, free measurement'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",13.0,0.0440985,β-hydroxybutyrate levels were significantly increased and triglycerides and free T3 hormone levels significantly reduced by the PL intervention.,"[{'ForeName': 'Rainer J', 'Initials': 'RJ', 'LastName': 'Klement', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany. rainer_klement@gmx.de.'}, {'ForeName': 'Petra S', 'Initials': 'PS', 'LastName': 'Koebrunner', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Krage', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Weigel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leopoldina Hospital, Schweinfurt, Germany.'}, {'ForeName': 'Reinhart A', 'Initials': 'RA', 'LastName': 'Sweeney', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}]","Medical oncology (Northwood, London, England)",['10.1007/s12032-020-01443-0']
2799,33251643,Effects of Empagliflozin on Renal Sodium and Glucose Handling in Patients with Acute Heart Failure.,"AIMS
Sodium-glucose cotransporter-2 (SGLT2) inhibitors improve clinical outcome in patients with heart failure (HF), but the mechanisms behind their beneficial effects are not yet fully understood. We examined the effects of empagliflozin on renal sodium and glucose handling in patients with acute HF.
METHODS AND RESULTS
This study was a predefined sub-study of a double-blind, randomized, placebo-controlled, multicenter study (EMPA-RESPONSE-AHF). Patients were allocated within 24 hours of an acute HF admission to either empagliflozin 10 mg/day (n=40) or placebo (n=39) for 30 days. Markers of glucose and sodium handling were measured daily during the first 96 hours and at day 30. Patients were 76 (range 38-89) years old and 33% had diabetes. The use of loop diuretics during the first 96 hours was similar in both groups. Empagliflozin increased fractional glucose excretion with a peak after 24 hours (21.8 vs 0.1%; P<0.001), without affecting plasma glucose concentration, while fractional sodium and chloride excretion and urinary osmolality remained unchanged (P for all >0.3). However, empagliflozin increased plasma osmolality (delta osmolality at 72 hours: 5±8 versus 2±5 mOsm/kg; P=0.049). Finally, there was an early decline in eGFR with empagliflozin versus placebo (-10±12 vs. -2±12 mL/min/1.73m 2 P=0.009), which recovered within 30 days CONCLUSION: In patients with acute HF, empagliflozin increased fractional glucose excretion and plasma osmolality, without affecting fractional sodium excretion or urine osmolality and caused a temporary decline in eGFR. This suggests that empagliflozin stimulates osmotic diuresis through increased glycosuria rather than natriuresis in patients with acute HF.",2020,"Empagliflozin increased fractional glucose excretion with a peak after 24 hours (21.8 vs 0.1%; P<0.001), without affecting plasma glucose concentration, while fractional sodium and chloride excretion and urinary osmolality remained unchanged (P for all >0.3).","['patients with acute HF', 'Patients were 76 (range 38-89) years old and 33% had diabetes', 'Patients with Acute Heart Failure', 'patients with heart failure (HF']","['empagliflozin', 'placebo', 'Empagliflozin', 'loop diuretics', 'Sodium-glucose cotransporter-2 (SGLT2) inhibitors']","['plasma glucose concentration, while fractional sodium and chloride excretion and urinary osmolality', 'fractional glucose excretion and plasma osmolality', 'Renal Sodium and Glucose Handling', 'fractional glucose excretion', 'plasma osmolality (delta osmolality', 'renal sodium and glucose handling']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0354100', 'cui_str': 'Loop diuretic'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0860721', 'cui_str': 'Plasma osmolality'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0439097', 'cui_str': 'Delta'}]",,0.100313,"Empagliflozin increased fractional glucose excretion with a peak after 24 hours (21.8 vs 0.1%; P<0.001), without affecting plasma glucose concentration, while fractional sodium and chloride excretion and urinary osmolality remained unchanged (P for all >0.3).","[{'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Boorsma', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Joost C', 'Initials': 'JC', 'LastName': 'Beusekamp', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jozine M', 'Initials': 'JM', 'LastName': 'Ter Maaten', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sylwia M', 'Initials': 'SM', 'LastName': 'Figarska', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'A H Jan', 'Initials': 'AHJ', 'LastName': 'Danser', 'Affiliation': 'Department of Internal Medicine, Division of Pharmacology, Erasmus University Medical Center Rotterdam, Rotterdam, The Netherlands.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van der Meer', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Damman', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",European journal of heart failure,['10.1002/ejhf.2066']
2800,33251579,Effect of low-dose colchicine in acute and chronic coronary syndromes.,"BACKGROUND
Sparse evidence of the prognostic benefit of the anti-inflammatory drug colchicine in chronic and acute coronary syndromes (CCS/ACS) exists.
METHODS
We performed a systematic search of studies on CCS or ACS comparing colchicine vs. placebo and reporting data on cardiovascular outcomes (primary endpoints of each study) and/or changes in hs-CRP.
RESULTS
Ten studies were selected: three on CCS (LoDoCo, LoDoCo2 and the CCS subgroup of COLCHICINE-PCI; total patient number=6,256), three on ACS (COLCOT, COPS, ACS subgroup of COLCHICINE-PCI; n=5,654), and five (n=532) on hs-CRP changes from 1 week to 12 months, in CCS and/or ACS. In patients with CCS, colchicine reduced by 49% the risk of a composite endpoint (hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.32 to 0.81, P=0.005). The favorable effect of colchicine on the risk of cardiovascular events did not change when excluding COLCHICINE-PCI from analysis (HR 0.51, 95% CI 0.25 to 1.03, P=0.061). In patients with ACS, the use of colchicine tended to decrease the occurrence of the combined endpoint compared with placebo (HR=0.77, 95% CI 0.56 to 1.05, P=0.100), and colchicine became significantly protective when removing COLCHICINE-PCI from analysis (HR=0.72, 95% CI 0.56 to 0.92, P=0.009). Furthermore, colchicine tended to reduce the hs-CRP increase (standardized mean difference=-0.31, 95% CI -0.72 to 0.1, P=0.133) compared with placebo.
CONCLUSIONS
Colchicine therapy near halves the risk of cardiovascular events in CCS compared with placebo, and is associated with a non-significant 23% risk reduction in ACS, together with a trend toward a greater reduction of hs-CRP.",2020,"In patients with ACS, the use of colchicine tended to decrease the occurrence of the combined endpoint compared with placebo (HR=0.77, 95% CI 0.56 to 1.05, P=0.100), and colchicine became significantly protective when removing COLCHICINE-PCI from analysis (HR=0.72, 95% CI 0.56 to 0.92, P=0.009).",['acute and chronic coronary syndromes'],"['CCS (LoDoCo, LoDoCo2', 'low-dose colchicine', 'placebo', 'colchicine vs. placebo', 'Colchicine', 'colchicine']","['hs-CRP increase (standardized mean', 'reduction of hs-CRP', 'risk of cardiovascular events']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1963867', 'cui_str': 'High-sensitivity C-reactive protein increased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.408407,"In patients with ACS, the use of colchicine tended to decrease the occurrence of the combined endpoint compared with placebo (HR=0.77, 95% CI 0.56 to 1.05, P=0.100), and colchicine became significantly protective when removing COLCHICINE-PCI from analysis (HR=0.72, 95% CI 0.56 to 0.92, P=0.009).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Aimo', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Domingo A', 'Initials': 'DA', 'LastName': 'Pascual Figal', 'Affiliation': 'Cardiology Department, Virgen de la Arrixaca Hospital and School of Medicine, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayes-Genis', 'Affiliation': 'CIBER Cardiovascular, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Pisa, Italy.""}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Georgiopoulos', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, King's College London, St Thomas' Hospital Campus, London, UK.""}]",European journal of clinical investigation,['10.1111/eci.13464']
2801,33251538,Comparing Three Music Therapy Interventions for Anxiety and Relaxation in Youth With Amplified Pain.,"Research in pediatric hospitals has shown that active music engagement, preferred music listening, and music-assisted relaxation can decrease anxiety and increase relaxation responses. However, there is little research on the use of music therapy with pediatric chronic pain conditions such as amplified pain syndromes. The purpose of the current study was to examine the effects of 3 specific music therapy interventions (active music engagement, live patient-selected music, and music-assisted relaxation) on anxiety and relaxation levels in youth (ages 10-18) participating in a 40 hr per week hospital-based intensive interdisciplinary pain treatment program. A sample of 48 patients participated in this study which utilized a 3-period, 3-treatment cross-over design with 3 interventions delivered in a quasi-randomized order determined by when the patients started the treatment program. State anxiety was measured via the state form of the State-Trait Inventory for Cognitive and Somatic Anxiety for Children and relaxation scores were assessed with a Visual Analog Scale. Statistically significant changes were found in anxiety and relaxation outcomes across all interventions provided. Results suggest that music therapy services (using active music engagement, live patient-selected music, and music-assisted relaxation) may be an effective modality to decrease anxiety and increase relaxation levels in pediatric patients with amplified pain syndromes.",2020,Statistically significant changes were found in anxiety and relaxation outcomes across all interventions provided.,"['youth (ages 10-18) participating in a 40 hr per week hospital-based intensive interdisciplinary pain treatment program', '48 patients participated', 'pediatric patients with amplified pain syndromes', 'Youth With Amplified Pain']","['Music Therapy Interventions', 'specific music therapy interventions (active music engagement, live patient-selected music, and music-assisted relaxation', 'music therapy']","['anxiety and relaxation outcomes', 'anxiety and relaxation levels', 'State-Trait Inventory for Cognitive and Somatic Anxiety for Children and relaxation scores', 'anxiety and increase relaxation responses', 'State anxiety', 'relaxation levels']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}]",48.0,0.0891946,Statistically significant changes were found in anxiety and relaxation outcomes across all interventions provided.,"[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Scheufler', 'Affiliation': ""Children's Mercy Hospital, Kansas City, MO, USA.""}, {'ForeName': 'Dustin P', 'Initials': 'DP', 'LastName': 'Wallace', 'Affiliation': ""Children's Mercy Hospital, Kansas City, MO, USA.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': ""Children's Mercy Hospital, Kansas City, MO, USA.""}]",Journal of music therapy,['10.1093/jmt/thaa021']
2802,33251528,"Testosterone Responses to Intensive, Prolonged Endurance Exercise in Women.","Objective
To examine the response of testosterone in women to an intensive, prolonged endurance exercise bout that mimicked a competitive event.
Methods
Ten healthy eumenorrheic women ran to exhaustion at ~100% of their ventilatory threshold in their follicular menstrual cycle phase. Testosterone measures were assessed pre-exercise, immediately, 30 min, 60 min, 90 min, and 24 h post-exercise.
Results
At exhaustion (75.1 ± 7.0 min), total (56%), free (36%), and bioavailable testosterone (50%) were increased from pre-exercise values ( p < 0.05). At 24 h post-exercise, these measures were decreased from pre-exercise values (-21%, -31%, -18%, respectively; p < 0.05). Effect sizes for these changes ranged from medium to large in magnitude.
Conclusion
Testosterone was elevated in the early recovery period following exhaustive endurance exercise but was reduced by 24 h afterward. These outcomes are comparable to responses seen in men when sex-based concentration differences are considered.",2020,"At 24 h post-exercise, these measures were decreased from pre-exercise values (-21%, -31%, -18%, respectively; p < 0.05).","['Women', 'healthy eumenorrheic women ran to exhaustion at ~100% of their ventilatory threshold in their follicular menstrual cycle phase']","['Testosterone Responses to Intensive, Prolonged Endurance Exercise']","['Testosterone measures', 'bioavailable testosterone', 'pre-exercise values']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0370051', 'cui_str': 'Bioavailable testosterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",10.0,0.191953,"At 24 h post-exercise, these measures were decreased from pre-exercise values (-21%, -31%, -18%, respectively; p < 0.05).","[{'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Hannah N', 'Initials': 'HN', 'LastName': 'Willett', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, NC 27599, USA.'}]",Endocrines,['10.3390/endocrines1020011']
2803,33243145,Improving medication appropriateness in nursing homes via structured interprofessional medication-review supported by health information technology: a non-randomized controlled study.,"BACKGROUND
In nursing home residents (NHRs), polypharmacy is widespread, accompanied by elevated risks of medication related complications. Managing medication in NHRs is a priority, but prone to several challenges, including interprofessional cooperation. Against this background, we implemented and tested an interprofessional intervention aimed to improve medication appropriateness for NHRs.
METHODS
A non-randomized controlled study (SiMbA; ""Sicherheit der Medikamentherapie bei AltenheimbewohnerInnen"", Safety of medication therapy in NHRs) was conducted in six nursing homes in Austria (2016-2018). Educational training, introduction of tailored health information technology (HIT) and a therapy check process were combined in an intervention aimed at healthcare professionals. Medication appropriateness was assessed using the Medication Appropriateness Index (MAI). Data was collected before (t0), during (t1, month 12) and after (t2, month 18) intervention via self-administered assessments and electronic health records.
RESULTS
We included 6 NHs, 17 GPs (52.94% female) and 240 NHRs (68.75% female; mean age 85.0). Data of 159 NHRs could be included in the analysis. Mean MAI-change was - 3.35 (IG) vs. - 1.45 (CG). In the subgroup of NHRs with mean MAI ≥23, MAI-change was - 10.31 (IG) vs. -3.52 (CG). The intervention was a significant predictor of improvement in MAI when controlled for in a multivariable regression model.
CONCLUSIONS
Improvement of medication appropriateness was clearest in residents with inappropriate baseline MAI-scores. This improvement was independent of variances in certain covariates between the intervention and the control group. We conclude that our intervention is a feasible approach to improve NHRs' medication appropriateness.
TRIAL REGISTRATION
DRKS Data Management, ID: DRKS00012246 . Registered 16.05.2017 - Retrospectively registered.",2020,Mean MAI-change was - 3.35 (IG) vs. - 1.45 (CG).,"['six nursing homes in Austria (2016-2018', 'We included 6 NHs, 17 GPs (52.94% female) and 240 NHRs (68.75% female; mean age 85.0']","['Educational training, introduction of tailored health information technology (HIT']","['Mean MAI-change', 'MAI', 'Medication Appropriateness Index (MAI']","[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C2936756', 'cui_str': 'Health Information Technology'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4046084', 'cui_str': 'Medication Appropriateness Index'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0398752,Mean MAI-change was - 3.35 (IG) vs. - 1.45 (CG).,"[{'ForeName': 'Johanna Katharina', 'Initials': 'JK', 'LastName': 'Dellinger', 'Affiliation': 'Institute of Nursing Science and Practice, Paracelsus Medical University, Salzburg, Austria. johanna.dellinger@pmu.ac.at.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pitzer', 'Affiliation': 'Institute of Nursing Science and Practice, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schaffler-Schaden', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Maria Magdalena', 'Initials': 'MM', 'LastName': 'Schreier', 'Affiliation': 'Institute of Nursing Science and Practice, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Laura Sandre', 'Initials': 'LS', 'LastName': 'Fährmann', 'Affiliation': 'Institute of Pharmaceutic and Medical Chemistry, University of Münster, Münster, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Hempel', 'Affiliation': 'Institute of Pharmaceutic and Medical Chemistry, University of Münster, Münster, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Likar', 'Affiliation': 'Klinikum Klagenfurt am Wörthersee, Klagenfurt am Wörthersee, Austria.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Osterbrink', 'Affiliation': 'Institute of Nursing Science and Practice, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flamm', 'Affiliation': 'Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria.'}]",BMC geriatrics,['10.1186/s12877-020-01895-z']
2804,33243153,Hearing aids to support cognitive functions of older adults at risk of dementia: the HearCog trial- clinical protocols.,"BACKGROUND
Globally, about 50 million people were living with dementia in 2015, with this number projected to triple by 2050. With no cure or effective treatment currently insight, it is vital that factors are identified which will help prevent or delay both age-related and pathological cognitive decline and dementia. Observational data have suggested that hearing loss is a potentially modifiable risk factor for dementia, but no conclusive evidence from randomised controlled trials is currently available.
METHODS
The HearCog trial is a 24-month, randomised, controlled clinical trial aimed at determining whether a hearing loss intervention can delay or arrest the cognitive decline. We will randomise 180 older adults with hearing loss and mild cognitive impairment to a hearing aid or control group to determine if the fitting of hearing aids decreases the 12-month rate of cognitive decline compared with the control group. In addition, we will also determine if the expected clinical gains achieved after 12 months can be sustained over an additional 12 months and if losses experienced through the non-correction of hearing loss can be reversed with the fitting of hearing aids after 12 months.
DISCUSSION
The trial will also explore the cost-effectiveness of the intervention compared to the control arm and the impact of hearing aids on anxiety, depression, physical health and quality of life. The results of this trial will clarify whether the systematic correction of hearing loss benefits cognition in older adults at risk of cognitive decline. We anticipate that our findings will have implications for clinical practice and health policy development.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry ( ANZCTR: 12618001278224 ), registered on 30.07.2018.",2020,"The trial will also explore the cost-effectiveness of the intervention compared to the control arm and the impact of hearing aids on anxiety, depression, physical health and quality of life.","['180 older adults with hearing loss and mild cognitive impairment to a hearing aid or control group', 'older adults at risk of cognitive decline', '50 million people were living with dementia in 2015, with this number projected to triple by 2050', 'older adults at risk of dementia']","['Hearing aids', 'hearing loss intervention', 'hearing aids']","['anxiety, depression, physical health and quality of life', 'cost-effectiveness']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C3697373', 'cui_str': 'At risk of dementia'}]","[{'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",180.0,0.149229,"The trial will also explore the cost-effectiveness of the intervention compared to the control arm and the impact of hearing aids on anxiety, depression, physical health and quality of life.","[{'ForeName': 'Dona M P', 'Initials': 'DMP', 'LastName': 'Jayakody', 'Affiliation': 'Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008, Australia. dona.jayakody@uwa.edu.au.'}, {'ForeName': 'Osvaldo P', 'Initials': 'OP', 'LastName': 'Almeida', 'Affiliation': 'Western Australian Centre for Health and Ageing, Medical School, Faculty of Health and Medical Sciences, University of Western Australia, 35 Stirling Highway, Perth, WA, 6009, Australia.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ford', 'Affiliation': 'Western Australian Centre for Health and Ageing, Medical School, Faculty of Health and Medical Sciences, University of Western Australia, 35 Stirling Highway, Perth, WA, 6009, Australia.'}, {'ForeName': 'Marcus D', 'Initials': 'MD', 'LastName': 'Atlas', 'Affiliation': 'Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008, Australia.'}, {'ForeName': 'Nicola T', 'Initials': 'NT', 'LastName': 'Lautenschlager', 'Affiliation': 'Western Australian Centre for Health and Ageing, Medical School, Faculty of Health and Medical Sciences, University of Western Australia, 35 Stirling Highway, Perth, WA, 6009, Australia.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Friedland', 'Affiliation': 'Department of Otolaryngology, Head Neck Skull Base Surgery, Sir Charles Gairdner Hospital, Hospital Ave, Nedlands, WA, 6009, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': 'Curtin University, School of Public Health, Kent St, Bentley, WA, 6102, Australia.'}, {'ForeName': 'Marshall', 'Initials': 'M', 'LastName': 'Makate', 'Affiliation': 'Curtin University, School of Public Health, Kent St, Bentley, WA, 6102, Australia.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'Coetzee', 'Affiliation': 'Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008, Australia.'}, {'ForeName': 'Angela S P', 'Initials': 'ASP', 'LastName': 'Liew', 'Affiliation': 'Ear Science Institute Australia, 1 Salvado Road, Subiaco, WA, 6008, Australia.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Flicker', 'Affiliation': 'Western Australian Centre for Health and Ageing, Medical School, Faculty of Health and Medical Sciences, University of Western Australia, 35 Stirling Highway, Perth, WA, 6009, Australia.'}]",BMC geriatrics,['10.1186/s12877-020-01912-1']
2805,33243172,Can an mhealth clinical decision-making support system improve adherence to neonatal healthcare protocols in a low-resource setting?,"BACKGROUND
This study assessed health workers' adherence to neonatal health protocols before and during the implementation of a mobile health (mHealth) clinical decision-making support system (mCDMSS) that sought to bridge access to neonatal health protocol gap in a low-resource setting.
METHODS
We performed a cross-sectional document review within two purposively selected clusters (one poorly-resourced and one well-resourced), from each arm of a cluster-randomized trial at two different time points: before and during the trial. The total trial consisted of 16 clusters randomized into 8 intervention and 8 control clusters to assess the impact of an mCDMSS on neonatal mortality in Ghana. We evaluated health workers' adherence (expressed as percentages) to birth asphyxia, neonatal jaundice and cord sepsis protocols by reviewing medical records of neonatal in-patients using a checklist. Differences in adherence to neonatal health protocols within and between the study arms were assessed using Wilcoxon rank-sum and permutation tests for each morbidity type. In addition, we tracked concurrent neonatal health improvement activities in the clusters during the 18-month intervention period.
RESULTS
In the intervention arm, mean adherence was 35.2% (SD = 5.8%) and 43.6% (SD = 27.5%) for asphyxia; 25.0% (SD = 14.8%) and 39.3% (SD = 27.7%) for jaundice; 52.0% (SD = 11.0%) and 75.0% (SD = 21.2%) for cord sepsis protocols in the pre-intervention and intervention periods respectively. In the control arm, mean adherence was 52.9% (SD = 16.4%) and 74.5% (SD = 14.7%) for asphyxia; 45.1% (SD = 12.8%) and 64.6% (SD = 8.2%) for jaundice; 53.8% (SD = 16.0%) and 60.8% (SD = 11.7%) for cord sepsis protocols in the pre-intervention and intervention periods respectively. We observed nonsignificant improvement in protocol adherence in the intervention clusters but significant improvement in protocol adherence in the control clusters. There were 2 concurrent neonatal health improvement activities in the intervention clusters and over 12 in the control clusters during the intervention period.
CONCLUSION
Whether mHealth interventions can improve adherence to neonatal health protocols in low-resource settings cannot be ascertained by this study. Neonatal health improvement activities are however likely to improve protocol adherence. Future mHealth evaluations of protocol adherence must account for other concurrent interventions in study contexts.",2020,Differences in adherence to neonatal health protocols within and between the study arms were assessed using Wilcoxon rank-sum and permutation tests for each morbidity type.,[],[],"['mean adherence', ""health workers' adherence"", 'protocol adherence', 'neonatal health improvement activities']",[],[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4042838', 'cui_str': 'Neonatal Health'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",16.0,0.0641559,Differences in adherence to neonatal health protocols within and between the study arms were assessed using Wilcoxon rank-sum and permutation tests for each morbidity type.,"[{'ForeName': 'Hannah Brown', 'Initials': 'HB', 'LastName': 'Amoakoh', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands. ansomaame@hotmail.com.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Klipstein-Grobusch', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Irene Akua', 'Initials': 'IA', 'LastName': 'Agyepong', 'Affiliation': 'Research and Development Division, Ghana Health Service, Dodowa, Accra, Ghana.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Amoakoh-Coleman', 'Affiliation': 'Noguchi Memorial Institute, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Gbenga A', 'Initials': 'GA', 'LastName': 'Kayode', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Reitsma', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Diederick E', 'Initials': 'DE', 'LastName': 'Grobbee', 'Affiliation': 'Julius Global Health, Julius Center for Health Sciences and Primary Care, University Medical Centre, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Evelyn K', 'Initials': 'EK', 'LastName': 'Ansah', 'Affiliation': 'University of Health and Allied Sciences, Ho, Ghana.'}]",BMC pediatrics,['10.1186/s12887-020-02378-1']
2806,33244954,[Cytoflavin as a modulator of rehabilitation treatment of patients with ischemic stroke complicated by post-intensive care syndrome].,"OBJECTIVE
To assess an effect of cytoflavin on the results of rehabilitation treatment and the increase in exercise tolerance in patients with stroke complicated by post-intensive care syndrome (PICS).
MATERIAL AND METHODS
The data of 53 patients who underwent neurorehabilitation in the ICU after ischemic stroke were analyzed. Depending on the treatment regimen, the patients were divided into two groups. Group 1 (main, n =36) received cytoflavin (iv drip in a volume of 10 ml of a solution for injections per 200 ml of a 0.9% solution of sodium chloride) for 10 days in addition to the complex of neurorehabilitation measures. Group 2 (control, n =17) included patients, who had only a standard set of neurorehabilitation measures for 10 days. The efficacy of the therapy was evaluated using indirect calorimetry, and the oxygen and energy load price index was calculated. To assess the tolerability of rehabilitation methods, a verticalization test was used. Treatment tolerance was assessed by the incidence of adverse reactions in each group.
RESULTS AND CONCLUSION
The components of the energytropic effect of cytoflavin can have a positive modulating effect, increasing the tolerance of rehabilitation measures for the treatment of PICS in patients with ischemic stroke. Further research is required.",2020,"Treatment tolerance was assessed by the incidence of adverse reactions in each group.
","['patients with stroke complicated by post-intensive care syndrome (PICS', 'Group 2 (control, n =17) included patients, who had only a standard set of neurorehabilitation measures for 10 days', '53 patients who underwent neurorehabilitation in the ICU after ischemic stroke', 'patients with ischemic stroke complicated by post-intensive care syndrome', 'patients with ischemic stroke']","['cytoflavin (iv drip in a volume of 10 ml of a solution for injections per 200 ml of a 0.9% solution of sodium chloride', 'cytoflavin', 'Cytoflavin']","['Treatment tolerance', 'adverse reactions', 'exercise tolerance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0204096', 'cui_str': 'Neurological rehabilitation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C1701400', 'cui_str': 'cytoflavin'}, {'cui': 'C1621368', 'cui_str': 'Drip Infusions'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0991511', 'cui_str': 'Solution for injection'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}]",,0.0250291,"Treatment tolerance was assessed by the incidence of adverse reactions in each group.
","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Belkin', 'Affiliation': 'Clinical Institute of the Brain, Berezovsky, Russia.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Leiderman', 'Affiliation': 'Clinical Institute of the Brain, Berezovsky, Russia.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Kovalenko', 'Affiliation': 'Institute of Toxicology, Federal Biomedical Agency, St. Petersburg, Russia.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Rizakhanova', 'Affiliation': 'Mechnikov North-Western State Medical University, St-Petersburg, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Parfenov', 'Affiliation': 'North-West Institute of Management of RANEPA, St-Petersburg, Russia.'}, {'ForeName': 'K V', 'Initials': 'KV', 'LastName': 'Sapozhnikov', 'Affiliation': 'North-West Institute of Management of RANEPA, St-Petersburg, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012010127']
2807,33244956,[Developmental dysphasia in children: a comparison of the effectiveness of two modes of peptidergic nootropic therapy].,"OBJECTIVE
To study the therapeutic efficacy of two treatment modes of peptidergic nootropic medication cortexin in children with developmental dysphasia aged 3-4 years.
MATERIAL AND METHODS
Ninety-four children with developmental dysphasia were divided into three groups. In group 1 (27 patients), cortexin was administered once a day intramuscularly for 10 days. After this course, the children were not prescribed drug therapy, a second examination was carried out 2 months after the start of treatment. In group 2 (40 patients), two courses of cortexin were administered at 1-month intervals, and the children were also followed up for two months. Control group 3 (27 patients) did not receive medication, but was also followed up for two months. All the parents were provided with recommendations for the stimulation of speech development in children. Before the study and two months later, speech development was assessed with special scales and questionnaires for parents.
RESULTS
The increase ratio of the active vocabulary volume by 2 times or more was observed in group 2 (two courses of cortexin treatment) in 80.0% of patients (significant differences with groups 1 and 3, p <0.001), in 44.4% of group 1 (one course of cortexin), in 22.2% of the control group. Over a two-month period, the increase ratio in the active vocabulary and the number of uttered phrases in group 2 was 2.8 and 4.2 times, in group 1 2.3 and 3.6 times, respectively, in the control group it was only 1.4 and 1.5 times. Furthermore, the volume of active vocabulary in group 2 (42.4±3.6) became significantly larger ( p =0.01) than in group 1 (31.7±5.6), although its initial values in group 1 (13.7±1.8) and group 2 (14.9±1.7) were similar.
CONCLUSION
The results of the study confirm the higher effectiveness of two courses of the peptidergic nootropic medication cortexin in the pharmacotherapy of developmental dysphasia in children, aged 3-4 years, conducted over two months, compared with the indication of one treatment course.",2020,"The increase ratio of the active vocabulary volume by 2 times or more was observed in group 2 (two courses of cortexin treatment) in 80.0% of patients (significant differences with groups 1 and 3, p <0.001), in 44.4% of group 1 (one course of cortexin), in 22.2% of the control group.","['Ninety-four children with developmental dysphasia', 'developmental dysphasia in children, aged 3-4 years', 'children', 'children with developmental dysphasia aged 3-4 years']","['peptidergic nootropic medication cortexin', 'cortexin', 'peptidergic nootropic therapy']","['increase ratio of the active vocabulary volume', 'volume of active vocabulary', 'increase ratio in the active vocabulary and the number of uttered phrases']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454652', 'cui_str': 'Developmental dysphasia'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242913', 'cui_str': 'Antidementia agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0208872', 'cui_str': 'cortexin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600665', 'cui_str': 'Phrase'}]",94.0,0.0164321,"The increase ratio of the active vocabulary volume by 2 times or more was observed in group 2 (two courses of cortexin treatment) in 80.0% of patients (significant differences with groups 1 and 3, p <0.001), in 44.4% of group 1 (one course of cortexin), in 22.2% of the control group.","[{'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Zavadenko', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Davydova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}, {'ForeName': 'N Yu', 'Initials': 'NY', 'LastName': 'Suvorinova', 'Affiliation': 'Pirogov Russian National Research Medical University, Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012010138']
2808,33244958,"[Pain, emotion, cognition. Pathogenetic relationships and effects of therapy with nonsteroidal anti-inflammatory drugs].","OBJECTIVE
To study the dynamics of pain intensity in comparison with changes in the severity of depression and cognitive deficits when using non-steroidal anti-inflammatory drugs and/or central muscle relaxants in patients with chronic non-specific back pain.
MATERIAL AND METHODS
Sixty patients (26 men and 34 women), aged 42 to 59 years, with chronic non-specific back pain were examined. All patients were divided into three groups. In the first group, dexketoprofen was used at a dose of 75-100 mg per day for 10 days. Patients of the second group received dexketoprofen according to a similar scheme, as well as tolperisone (200-450 mg per day) for 30 days. Patients of the third group took diclofenac sodium (100 mg per day) for 10 days. The intensity of pain, its affective component, the severity of asthenic, depressive, anxiety manifestations and cognitive disorders were tested at baseline and on the 10th and 30th days.
RESULTS
Pain significantly decreased in all patients, more significantly in the first and second groups. The analgesic effect in the first and third groups was unstable, and the improvements achieved by the last test were partially reduced. In patients of the first and second groups, regression of anxiety and depressive symptoms was observed from day 10 to the end of observation. At the same time, the emotional assessment of pain in patients of the first group decreased by the 10th and increased by the 30th day of observation. By the end of the study, patients of the second group showed positive dynamics of indicators of asthenia and cognitive disorders.
CONCLUSIONS
The most effective analgesic therapy using a combination of dexketoprofen and tolperisone was accompanied by a positive dynamics of depressive manifestations and cognitive disorders. The choice of an algorithm for treating pain should take into account the need and possibility of treatment its biological and psychological (affective, cognitive) components.",2020,"The analgesic effect in the first and third groups was unstable, and the improvements achieved by the last test were partially reduced.","['Sixty patients (26 men and 34 women), aged 42 to 59 years, with chronic non-specific back pain were examined', 'patients with chronic non-specific back pain']","['diclofenac sodium', 'steroidal anti-inflammatory drugs and/or central muscle relaxants', 'dexketoprofen', 'nonsteroidal anti-inflammatory drugs']","['positive dynamics of indicators of asthenia and cognitive disorders', 'Pain', 'Pain, emotion, cognition', 'analgesic effect', 'emotional assessment of pain', 'intensity of pain, its affective component, the severity of asthenic, depressive, anxiety manifestations and cognitive disorders', 'regression of anxiety and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0026833', 'cui_str': 'Centrally acting muscle relaxant'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0142267,"The analgesic effect in the first and third groups was unstable, and the improvements achieved by the last test were partially reduced.","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Iskra', 'Affiliation': 'Saint-Petersburg State Pediatric Medical University, St-Petersburg, Russia.'}, {'ForeName': 'D Yu', 'Initials': 'DY', 'LastName': 'Butko', 'Affiliation': 'Saint-Petersburg State Pediatric Medical University, St-Petersburg, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012010151']
2809,33246494,Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design.,"BACKGROUND
Breast cancer treatment with radiotherapy can induce late radiation toxicity, characterized by pain, fibrosis, edema, impaired arm mobility, and poor cosmetic outcome. Hyperbaric oxygen therapy (HBOT) has been proposed as treatment for late radiation toxicity; however, high-level evidence of effectiveness is lacking. As HBOT is standard treatment and reimbursed by insurers, performing classic randomized controlled trials is difficult. The ""Hyperbaric OxygeN therapy on brEast cancer patients with late radiation toxicity"" (HONEY) trial aims to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the trial within cohorts (TwiCs) design.
METHODS
The HONEY trial will be conducted within the Utrecht cohort for Multiple BREast cancer intervention studies and Long-term evaluation (UMBRELLA). Within UMBRELLA, breast cancer patients referred for radiotherapy to the University Medical Centre Utrecht are eligible for inclusion. Patients consent to collection of clinical data and patient-reported outcomes and provide broad consent for randomization into future intervention studies. Patients who meet the HONEY in- and exclusion criteria (participation ≥ 12 months in UMBRELLA, moderate/severe breast or chest wall pain, completed primary breast cancer treatment except hormonal treatment, no prior treatment with HBOT, no contraindications for HBOT, no clinical signs of metastatic or recurrent disease) will be randomized to HBOT or control group on a 2:1 ratio (n = 120). Patients in the control group will not be informed about participation in the trial. Patients in the intervention arm will undergo 30-40 HBOT treatment sessions in a high pressure chamber (2.4 atmospheres absolute) where they inhale 100% oxygen through a mask. Cohort outcome measures (i.e., physical outcomes, quality of life, fatigue, and cosmetic satisfaction) of the HBOT group will be compared to the control group at 3 months follow-up.
DISCUSSION
This pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design. Use of the TwiCs design is expected to address issues encountered in classic randomized controlled trials, such as contamination (i.e., HBOT in the control group) and disappointment bias, and generate information about acceptability of HBOT.
TRIAL REGISTRATION
ClinicalTrials.gov. NCT04193722 . Registered on 10 December 2019.",2020,This pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design.,"['breast cancer patients referred for radiotherapy to the University Medical Centre Utrecht are eligible for inclusion', 'breast cancer patients using the trial within cohorts (TwiCs) design', 'breast cancer patients with late radiation toxicity (HONEY trial', 'Patients who meet the HONEY in- and exclusion criteria (participation ≥\u200912\u2009months in UMBRELLA, moderate/severe breast or chest wall pain, completed primary breast cancer treatment except hormonal treatment, no prior treatment with HBOT, no contraindications for HBOT, no clinical signs of metastatic or recurrent disease', 'brEast cancer patients with late radiation toxicity"" (HONEY', 'breast cancer patients using the TwiCs design']","['radiotherapy', 'Hyperbaric oxygen therapy (HBOT', 'Hyperbaric OxygeN therapy', 'HBOT', 'hyperbaric oxygen therapy']","['late radiation toxicity', 'physical outcomes, quality of life, fatigue, and cosmetic satisfaction']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0420378', 'cui_str': 'Referred for radiotherapy'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0008035', 'cui_str': 'Chest wall pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0780113,This pragmatic trial within the UMBELLA cohort was designed to evaluate the effectiveness of HBOT on late radiation toxicity in breast cancer patients using the TwiCs design.,"[{'ForeName': 'M C T', 'Initials': 'MCT', 'LastName': 'Batenburg', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Utrecht, Heidelberglaan 100, 3584 CZ, Utrecht, the Netherlands. m.c.t.batenburg-3@umcutrecht.nl.'}, {'ForeName': 'H J G D', 'Initials': 'HJGD', 'LastName': 'van den Bongard', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Utrecht, Heidelberglaan 100, 3584 CZ, Utrecht, the Netherlands.'}, {'ForeName': 'C E', 'Initials': 'CE', 'LastName': 'Kleynen', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Utrecht, Heidelberglaan 100, 3584 CZ, Utrecht, the Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Maarse', 'Affiliation': 'Department of Plastic, Reconstructive and Hand Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Witkamp', 'Affiliation': 'Department of Surgery, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Department of Surgery, Alexander Monro Ziekenhuis, Bilthoven, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Doeksen', 'Affiliation': 'Department of Surgery, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van Dalen', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Utrecht, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sier', 'Affiliation': 'Department of Surgery, St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'E J P', 'Initials': 'EJP', 'LastName': 'Schoenmaeckers', 'Affiliation': 'Department of Surgery, Meander Medisch Centrum, Amersfoort, the Netherlands.'}, {'ForeName': 'I O', 'Initials': 'IO', 'LastName': 'Baas', 'Affiliation': 'Department of Oncology, University Medical Centre Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Imaging Division, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]",Trials,['10.1186/s13063-020-04869-z']
2810,33246495,Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial.,"BACKGROUND
Vietnam has been experiencing an epidemiologic transition to that of a lower-middle income country with an increasing prevalence of non-communicable diseases. The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN). Inasmuch, the burden of CVD will continue to increase in the Vietnamese population unless effective prevention and control measures are put in place. The objectives of the proposed project are to evaluate the implementation and effectiveness of two multi-faceted community and clinic-based strategies on the control of elevated blood pressure (BP) among adults in Vietnam via a cluster randomized trial design.
METHODS
Sixteen communities will be randomized to either an intervention (8 communities) or a comparison group (8 communities). Eligible and consenting adult study participants with HTN (n = 680) will be assigned to intervention/comparison status based on the community in which they reside. Both comparison and intervention groups will receive a multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program. In addition, the intervention group only will receive three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a ""storytelling intervention,"" which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices. The storytelling intervention will be delivered by DVDs with serial installments at baseline and at 3, 6, and 9 months after trial enrollment. Changes in BP will be assessed in both groups at several follow-up time points. Implementation outcomes will be assessed as well.
DISCUSSION
Results from this full-scale trial will provide health policymakers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03590691 . Registered on July 17, 2018. Protocol version: 6. Date: August 15, 2019.",2020,"The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN).","['Sixteen communities', 'Eligible and consenting adult study participants with HTN (n\u2009=\u2009680', 'adults in Vietnam via a cluster randomized trial design']","['multi-level intervention modeled after the Vietnam National Hypertension Program including education and practice change modules for health care providers, accessible reading materials for patients, and a multi-media community awareness program', 'three carefully selected enhancements integrated into routine clinical care: (1) expanded community health worker services, (2) home BP self-monitoring, and (3) a ""storytelling intervention,"" which consists of interactive, literacy-appropriate, and culturally sensitive multi-media storytelling modules for motivating behavior change through the power of patients speaking in their own voices']","['Changes in BP', 'elevated blood pressure (BP']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0042939', 'cui_str': 'Voice'}]","[{'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",16.0,0.0767034,"The key risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam, particularly hypertension (HTN).","[{'ForeName': 'Duc A', 'Initials': 'DA', 'LastName': 'Ha', 'Affiliation': 'Ministry of Health, Hanoi, Vietnam.'}, {'ForeName': 'Oanh T', 'Initials': 'OT', 'LastName': 'Tran', 'Affiliation': 'Health Strategy and Policy Institute, Hanoi, Vietnam.'}, {'ForeName': 'Hoa L', 'Initials': 'HL', 'LastName': 'Nguyen', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 N Lake Ave, Worcester, MA, 01655, USA. hoa.nguyen@umassmed.edu.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Chiriboga', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 N Lake Ave, Worcester, MA, 01655, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Goldberg', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 N Lake Ave, Worcester, MA, 01655, USA.'}, {'ForeName': 'Van H', 'Initials': 'VH', 'LastName': 'Phan', 'Affiliation': 'Health Strategy and Policy Institute, Hanoi, Vietnam.'}, {'ForeName': 'Cuc T', 'Initials': 'CT', 'LastName': 'Nguyen', 'Affiliation': 'Health Strategy and Policy Institute, Hanoi, Vietnam.'}, {'ForeName': 'Giang H', 'Initials': 'GH', 'LastName': 'Nguyen', 'Affiliation': 'Health Strategy and Policy Institute, Hanoi, Vietnam.'}, {'ForeName': 'Hien V', 'Initials': 'HV', 'LastName': 'Pham', 'Affiliation': 'Health Strategy and Policy Institute, Hanoi, Vietnam.'}, {'ForeName': 'Thang T', 'Initials': 'TT', 'LastName': 'Nguyen', 'Affiliation': 'Health Strategy and Policy Institute, Hanoi, Vietnam.'}, {'ForeName': 'Thanh T', 'Initials': 'TT', 'LastName': 'Le', 'Affiliation': 'National Heart Institute, Hanoi, Vietnam.'}, {'ForeName': 'Jeroan J', 'Initials': 'JJ', 'LastName': 'Allison', 'Affiliation': 'Department of Population and Quantitative Health Sciences, University of Massachusetts Medical School, 55 N Lake Ave, Worcester, MA, 01655, USA.'}]",Trials,['10.1186/s13063-020-04917-8']
2811,33246497,Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial.,"BACKGROUND
Trigger finger is a common hand disorder that limits finger range of motion and causes pain and snapping of the affected finger. Trigger finger is caused by an imbalance of the tendon sheath and the flexor tendon. The initial treatment is generally a local corticosteroid injection around the first annular (A1) pulley. However, it is not unusual that surgical release of the A1 pulley is required. Moreover, adverse events after local corticosteroid injection or operative treatment may occur. Platelet-rich plasma (PRP) has been shown to be safe and to reduce symptoms in different tendon pathologies, such as DeQuervain's disease. However, the effects of PRP on trigger finger have not been studied. The aim of this single-center triple-blind randomized controlled trial is to study whether PRP is non-inferior to corticosteroid injection in treating trigger finger. The secondary outcome is to assess the safety and efficacy of PRP in comparison to placebo.
METHODS
The trial is designed as a randomized, controlled, patient-, investigator-, and outcome assessor-blinded, single-center, three-armed 1:1:1 non-inferiority trial. The patients with clinical symptoms of trigger finger will be randomly assigned to treatment with PRP, corticosteroid, or normal saline injection. The primary outcome is Patient-Rated Wrist Evaluation and symptom resolution. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications. Appropriate statistical methods will be applied.
DISCUSSION
We present a novel RCT study design on the use of PRP for the treatment of trigger finger compared to corticosteroid and normal saline injection. The results of the trial will indicate if PRP is appropriate for the treatment of trigger finger.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04167098 . Registered on November 18, 2019.",2020,"Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications.",['patients with clinical symptoms of trigger finger'],"['Platelet-rich plasma (PRP', 'PRP, corticosteroid, or normal saline injection', 'corticosteroid and normal saline injection', 'PRP', 'placebo', 'Platelet-rich plasma versus corticosteroid injection', 'corticosteroid injection']","['safety and efficacy of PRP', 'Patient-Rated Wrist Evaluation and symptom resolution', 'Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0158328', 'cui_str': 'Trigger finger'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.284086,"Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand; pain; grip strength; finger active range of motion; and complications.","[{'ForeName': 'Samuli', 'Initials': 'S', 'LastName': 'Aspinen', 'Affiliation': 'Department of Hand Surgery, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland. Samuli.aspinen@hus.fi.'}, {'ForeName': 'Panu H', 'Initials': 'PH', 'LastName': 'Nordback', 'Affiliation': 'Department of Hand Surgery, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland.'}, {'ForeName': 'Turkka', 'Initials': 'T', 'LastName': 'Anttila', 'Affiliation': 'Department of Hand Surgery, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Stjernberg-Salmela', 'Affiliation': 'Department of Hand Surgery, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Ryhänen', 'Affiliation': 'Department of Hand Surgery, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Kosola', 'Affiliation': 'Department of Orthopaedics and Traumatology, Kanta-Häme Central Hospital, Ahvenistontie 20, 13530, Hämeenlinna, Finland.'}]",Trials,['10.1186/s13063-020-04907-w']
2812,33246499,"A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial.","BACKGROUND
The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown.
METHODS
DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 h after randomization, with a second administration of 2 units 24 to 36 h after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma.
DISCUSSION
This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04429854 . Registered on 12 June 2020 - Retrospectively registered.",2020,"This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection.
","['patients hospitalized with COVID-19', 'Registered on 12 June 2020 - Retrospectively registered', 'Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72\u2009h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis', '483 patients and will recruit from 25 centres across Belgium', 'hospitalized patients with COVID-19 infection', 'patients hospitalized with COVID-19 in Belgium', 'DAWn']","['standard of care and convalescent plasma (active treatment group) or standard of care only', 'Donated Antibodies Working against nCoV']","['clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma', 'proportion of patients that require mechanical ventilation or have died']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.19009,"This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection.
","[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Devos', 'Affiliation': 'University Hospitals Leuven (UZ Leuven), Leuven, Belgium. timothy.devos@uzleuven.be.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Geukens', 'Affiliation': 'University Hospitals Leuven (UZ Leuven), Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schauvlieghe', 'Affiliation': 'Universitair Ziekenhuis Gent, Ghent, Belgium.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Ariën', 'Affiliation': 'Instituut voor Tropische Geneeskunde, Antwerp, Belgium.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Barbezange', 'Affiliation': 'Sciensano, Elsene, Belgium.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Cleeren', 'Affiliation': 'University Hospitals Leuven (UZ Leuven), Leuven, Belgium.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Compernolle', 'Affiliation': 'Rode Kruis Vlaanderen, Mechelen, Belgium.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dauby', 'Affiliation': ""Universite Libre de Bruxelles Institut d'Immunologie Medicale, Bruxelles, Belgium.""}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Desmecht', 'Affiliation': 'Universite de Liege, Liege, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Grimaldi', 'Affiliation': 'Universite Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Bart N', 'Initials': 'BN', 'LastName': 'Lambrecht', 'Affiliation': 'Universitair Ziekenhuis Gent, Ghent, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Luyten', 'Affiliation': 'Leuven Coordinating Centre, Leuven, Belgium.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Maes', 'Affiliation': 'Katholieke Universiteit Leuven Rega Institute for Medical Research, Leuven, Belgium.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Moutschen', 'Affiliation': 'Universite de Liege, Liege, Belgium.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Romano', 'Affiliation': 'Sciensano, Elsene, Belgium.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Seyler', 'Affiliation': 'Universitair Ziekenhuis Brussel, Bruxelles, Belgium.'}, {'ForeName': 'Michel Toungouz', 'Initials': 'MT', 'LastName': 'Nevessignsky', 'Affiliation': 'Croix Rouge de Belgique, Bruxelles, Belgium.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Vandenberghe', 'Affiliation': 'Leuven Coordinating Centre, Leuven, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'van Griensven', 'Affiliation': 'Instituut voor Tropische Geneeskunde, Antwerp, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Verbeke', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics, Leuven, Belgium.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Vlieghe', 'Affiliation': 'Universitair Ziekenhuis Antwerpen, Antwerpen, Belgium.'}, {'ForeName': 'Jean Cyr', 'Initials': 'JC', 'LastName': 'Yombi', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Sint-Lambrechts-Woluwe, Belgium.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Liesenborghs', 'Affiliation': 'Katholieke Universiteit Leuven Rega Institute for Medical Research, Leuven, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Verhamme', 'Affiliation': 'University Hospitals Leuven (UZ Leuven), Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Meyfroidt', 'Affiliation': 'University Hospitals Leuven (UZ Leuven), Leuven, Belgium.'}]",Trials,['10.1186/s13063-020-04876-0']
2813,33251988,THE WEEK AFTER RUNNING A MARATHON: EFFECTS OF RUNNING vs ELLIPTICAL TRAINING vs RESTING ON NEUROMUSCULAR PERFORMANCE AND MUSCLE DAMAGE RECOVERY.,"Our aim was to compare the effects of two exercise modalities vs resting on the time course of neuromuscular performance and muscle damage recovery during the week after running a marathon. Sixty-four finishers from a road marathon completed the study (54 men and 10 women; 39 ± 4 years; 3 h 35 min ± 21 min). The day before the race, within 15 min after finishing the marathon and at 24, 48, 96, 144 and 192 h postrace, lactate dehydrogenase and creatine kinase were analyzed. Participants also performed a squat jump (SJ) test before and after the marathon and at 48, 96 and 144 h postrace. On their arrival to the finish line, participants were randomized into one of the three intervention groups: running (RUN), elliptical training (ELIP) and resting recovery (REST). RUN and ELIP groups exercised continuously for 40 min at a moderate intensity (95-105% of the HR corresponding to the first ventilatory threshold) at 48, 96 and 144 h after the marathon. Neither 'Intervention' factor nor 'Intervention x Time' interaction effects were revealed for muscle damage blood markers (p>0.05). On the other hand, RUN group evidenced an enhancement in SJ performance 96 h post-marathon as compared with REST group (108.29 ± 10.64 vs 100.58 ± 9.16%, p=0.020, d=0.80). Consequently, return to running at 48 h post-marathon does not seem to have a negative impact on muscle damage recovery up to eight days post-race and it could be recommended in order to speed up neuromuscular recovery. Trial registration: ClinicalTrials.gov identifier: NCT03155633..",2020,Neither 'Intervention' factor nor 'Intervention x Time' interaction effects were revealed for muscle damage blood markers (p>0.05).,['Sixty-four finishers from a road marathon completed the study (54 men and 10 women; 39 ± 4 years; 3 h 35 min ± 21 min'],"['running (RUN), elliptical training (ELIP) and resting recovery (REST']",['SJ performance'],"[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]",54.0,0.0475732,Neither 'Intervention' factor nor 'Intervention x Time' interaction effects were revealed for muscle damage blood markers (p>0.05).,"[{'ForeName': 'Martinez-Navarro', 'Initials': 'MN', 'LastName': 'Ignacio', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Montoya-Vieco', 'Initials': 'MV', 'LastName': 'Antonio', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Hernando', 'Initials': 'H', 'LastName': 'Carlos', 'Affiliation': 'Sport Service, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Hernando', 'Initials': 'H', 'LastName': 'Barbara', 'Affiliation': 'Department of Medicine, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Panizo', 'Initials': 'P', 'LastName': 'Nayara', 'Affiliation': 'Department of Medicine, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Collado', 'Initials': 'C', 'LastName': 'Eladio', 'Affiliation': 'Faculty of Health Sciences, Jaume I University, Castellon, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1857441']
2814,33251910,Efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia: stage 2 results from a multicenter phase III study.,"This phase III, randomized, placebo-controlled study conducted in three stages (6-week, randomized, placebo-controlled stage 1; 24-week, open-label stage 2; and continuous extension stage 3) assessed the long-term efficacy and safety of eltrombopag use in Chinese patients with chronic immune thrombocytopenia (ITP). This article presents the results from stage 2. Overall, 150 patients (placebo-eltrombopag [P-E], 50; eltrombopag-eltrombopag [E-E], 100) received open-label eltrombopag. The median platelet count was maintained between 41 × 10 9 /L and 80 × 10 9 /L. Most patients in both groups (P-E, 90.0%; E-E, 81.8%) achieved platelet counts ≥30 × 10 9 /L and ≥2 times the baseline platelet count at least once with eltrombopag treatment. Overall, 32% of patients achieved platelet counts ≥50 × 10 9 /L in ≥75% of platelet count assessments. Both groups showed a decreased tendency to infrequent bleeding and clinically significant bleeding events during stage 2 compared with baseline. Among patients who received ≥1 ITP medication at baseline, 70.4% in the P-E group and 40.8% in the E-E group reduced or permanently stopped ≥1 of their ITP medications. The stage 2 results further demonstrated a sustainable long-term efficacy and good tolerability of eltrombopag with a favorable benefit-risk ratio in Chinese chronic ITP patients. Trial registration: Clinicaltrials.gov NCT01762761. Registered 8 January 2013, https://clinicaltrials.gov/ct2/show/NCT01762761.",2020,"Most patients in both groups (P-E, 90.0%; E-E, 81.8%) achieved platelet counts ≥30 ","['150 patients', 'Chinese chronic ITP patients', 'Chinese patients with chronic immune thrombocytopenia (ITP', 'Chinese patients with chronic immune thrombocytopenia', '10 9']","['placebo', 'placebo-eltrombopag', 'eltrombopag-eltrombopag [E-E], 100) received open-label eltrombopag', 'eltrombopag']","['infrequent bleeding and clinically significant bleeding events', 'platelet counts ≥30', 'Efficacy and safety', 'median platelet count', 'sustainable long-term efficacy and good tolerability', 'platelet counts ≥50', 'baseline platelet count']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.179537,"Most patients in both groups (P-E, 90.0%; E-E, 81.8%) achieved platelet counts ≥30 ","[{'ForeName': 'Xiaofan', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences , Tianjin, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': ""Qilu Hospital, Shandong University , Ji'nan, China.""}, {'ForeName': 'Junmin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University College of Medicine , Hangzhou, China.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Fujian Union Hospital, Fujian Medical University , Fuzhou, China.'}, {'ForeName': 'Ziqiang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'The First Affiliated Hospital of Soochow University, Soochow University , Suzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'The seventh Affiliated Hospital, Sun Yat-sen University, Shenzhen,China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Peking University People's Hospital, Peking University , Beijing, China.""}, {'ForeName': 'Renchi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences , Tianjin, China.'}]",Platelets,['10.1080/09537104.2020.1847267']
2815,33251855,Insomnia Precipitating Events among Women Veterans: The Impact of Traumatic and Nontraumatic Events on Sleep and Mental Health Symptoms.,"Objective/Background : The current study describes insomnia precipitating events reported by women Veterans and examines differences in sleep and psychological distress variables in those who endorsed traumatic, nontraumatic, or no insomnia precipitating events. Participants : Baseline data were collected from 347 women Veterans enrolled in a behavioral sleep intervention study (NCT02076165). Methods : Participants completed self-report measures of insomnia symptoms, sleep quality, sleep efficiency (SE), nightmare frequency, and depression and posttraumatic stress disorder (PTSD) symptoms; SE was also assessed by wrist actigraphy. Participants responded to 2 open-ended questions assessing stressful life events and health changes that coincided with insomnia symptom onset. Responses were coded as traumatic, nontraumatic, and no events. Analyses of covariance examined the effect of insomnia precipitating event type on sleep and psychological symptom variables after controlling for sociodemographic factors. Results : Overall, 25.80% of participants endorsed traumatic events, 65.80% endorsed only nontraumatic events, and 8.41% endorsed no events. Participants who endorsed traumatic events reported more severe insomnia ( p = .003), PTSD ( p = .001), and depression symptoms ( p = .012), and poorer quality of sleep ( p = .042) than participants who endorsed no events. Participants who endorsed traumatic events reported more severe PTSD symptoms ( p = .004), a longer duration of sleep problems ( p = .001), and poorer quality of sleep ( p = .039) than participants who endorsed nontraumatic events. Participants who endorsed nontraumatic events reported more severe insomnia ( p = .029) and PTSD ( p = .049) symptoms than participants who endorsed no events. Conclusions : Trauma as a precipitant for insomnia may be related to higher symptom severity in women Veterans. Implications for treatment engagement and effectiveness remain unstudied.",2020,"Participants who endorsed traumatic events reported more severe PTSD symptoms ( p = .004), a longer duration of sleep problems ( p = .001), and poorer quality of sleep ( p = .039) than participants who endorsed nontraumatic events.","['Participants ', 'Women Veterans', 'women Veterans', '347 women Veterans enrolled in a behavioral sleep intervention study (NCT02076165']",[' '],"['traumatic events', 'depression symptoms', 'insomnia symptoms, sleep quality, sleep efficiency (SE), nightmare frequency, and depression and posttraumatic stress disorder (PTSD) symptoms; SE', 'nontraumatic events', 'poorer quality of sleep', 'Insomnia Precipitating Events', 'severe PTSD symptoms', 'longer duration of sleep problems', 'severe insomnia']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}]",[],"[{'cui': 'C4751223', 'cui_str': 'Traumatic event'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]",347.0,0.0260287,"Participants who endorsed traumatic events reported more severe PTSD symptoms ( p = .004), a longer duration of sleep problems ( p = .001), and poorer quality of sleep ( p = .039) than participants who endorsed nontraumatic events.","[{'ForeName': 'Gwendolyn C', 'Initials': 'GC', 'LastName': 'Carlson', 'Affiliation': 'Veterans Affairs (VA) Health Services Research & Development Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Monica R', 'Initials': 'MR', 'LastName': 'Kelly', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Grinberg', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mitchell', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Sarah Kate', 'Initials': 'SK', 'LastName': 'McGowan', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Najwa C', 'Initials': 'NC', 'LastName': 'Culver', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Kay', 'Affiliation': 'Department of Mental Health, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Alessi', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Washington', 'Affiliation': 'Veterans Affairs (VA) Health Services Research & Development Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Yano', 'Affiliation': 'Veterans Affairs (VA) Health Services Research & Development Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Martin', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System , Los Angeles, California.'}]",Behavioral sleep medicine,['10.1080/15402002.2020.1846537']
2816,33250730,The Posterior Parietal Cortex Is Involved in Gait Adaptation: A Bilateral Transcranial Direct Current Stimulation Study.,"Gait is one of the fundamental behaviors we use to interact with the world. The functionality of the locomotor system is thus related to enriching interactions with our environment. The posterior parietal cortex (PPC) has been found to contribute to motor adaptation during both visuomotor and postural adaptation tasks. Additionally, structural or functional deficits of the PPC lead to impairments in gaits such as shortened steps and increased step width. Based on the aforementioned roles of the PPC, and the importance of gait adaptability, the current investigation sought to identify the role of the PPC in gait adaptation. To achieve this, we performed transcranial direct current stimulation (tDCS) over the bilateral PPC before performing a split-belt treadmill gait adaptation paradigm. We used three stimulation conditions in a within-subject design. tDCS was administered in a randomized and double-blinded order. Following each stimulation session, subjects first performed baseline walking with both belts running at the same speed. Then, subjects walked for 15 min on an uncoupled treadmill, with the belts being driven at a 3:1 speed ratio. Last, they returned to normal (i.e., tied-belt) walking for 5 min. Results from 15 young and healthy subjects identified that subjects required more steps to adapt to split-belt walking following the suppression of the left hemisphere PPC, contralateral to the fast belt. Furthermore, while suppression of the left hemisphere PPC did not increase the number of steps required to re-adapt to tied-belt walking, this condition did lead to increased magnitude of after-effects. Together, these findings indicate that the PPC is involved in locomotor adaptation. These results support previous literature regarding the upper body or postural adaptation and extend these findings to the realm of gait. Results highlight the PPC as a potential target for neurorehabilitation designed to improve gait adaptability.",2020,"Furthermore, while suppression of the left hemisphere PPC did not increase the number of steps required to re-adapt to tied-belt walking, this condition did lead to increased magnitude of after-effects.","['Gait Adaptation', '15 young and healthy subjects']","['transcranial direct current stimulation (tDCS', 'tDCS']","['gaits such as shortened steps and increased step width', 'gait adaptability']","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0487742', 'cui_str': 'Width'}]",15.0,0.0162595,"Furthermore, while suppression of the left hemisphere PPC did not increase the number of steps required to re-adapt to tied-belt walking, this condition did lead to increased magnitude of after-effects.","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Young', 'Affiliation': 'Department of Health and Human Performance, Center for Neuromotor and Biomechanics Research, College of Liberal Arts and Social Sciences, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Pranav J', 'Initials': 'PJ', 'LastName': 'Parikh', 'Affiliation': 'Department of Health and Human Performance, Center for Neuromotor and Biomechanics Research, College of Liberal Arts and Social Sciences, University of Houston, Houston, TX, United States.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Layne', 'Affiliation': 'Department of Health and Human Performance, Center for Neuromotor and Biomechanics Research, College of Liberal Arts and Social Sciences, University of Houston, Houston, TX, United States.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.581026']
2817,33250726,Acute Effects of Two Types of Dumbbell Exercise on Oxygenated Hemodynamic Concentration of Cerebral Activation in Healthy Young Male Adults: A Functional Near-Infrared Spectroscopy Study.,"Purpose : To examine cerebral cortical activation differences in the frontal cortex and parietal lobe during the performance of two types of dumbbell exercise. Methods : A total of 22 young healthy male adults (mean age, 23.8 ± 2.05 years; height, 1.75 ± 0.06 m; weight, 71.4 ± 8.80 kg) participated in a crossover design study that involved two experimental exercise conditions: momentum dumbbell and conventional dumbbell. Performance tasks included 10, 10-s sets of single-arm dumbbell exercise, with a rest interval of 60 s between sets and a 5-min washout period between conditions. The primary outcome was the cerebral concentrations of oxygenated hemoglobin (HbO 2 ) in the frontal cortex and parietal lobe assessed during performance of both exercises using functional near-infrared spectroscopy (fNIRS). The secondary outcome was upper-limb muscle activation measured using surface electromyography (sEMG). Outcome data were ascertained during exercise. Results : A significant between-condition difference in HbO 2 was observed in the frontal and parietal regions with an increase in HbO 2 during momentum, relative to conventional, dumbbell exercise ( p < 0.05). Compared to conventional dumbbell exercise, performing a momentum dumbbell exercise led to a higher level of muscle activation in the anterior and posterior deltoids of the upper arm and in the flexor carpi radialis and extensor carpi radialis longus of the forearm ( p < 0.05). However, no between-condition differences were found in the biceps and triceps brachii ( p > 0.05). Conclusion : Dynamic, compared with conventional, dumbbell exercise resulted in higher hemodynamic responses and greater upper-limb muscle activation in young healthy adults. The findings of this study showed differential cortical hemodynamic responses during performance of the two types of dumbbell exercise with a higher activation level produced during momentum-based dumbbell exercise.",2020,"A significant between-condition difference in HbO 2 was observed in the frontal and parietal regions with an increase in HbO 2 during momentum, relative to conventional, dumbbell exercise ( p < 0.05).","['young healthy adults', 'Healthy Young Male Adults', '22 young healthy male adults (mean age, 23.8 ± 2.05 years; height, 1.75 ± 0.06 m; weight, 71.4 ± 8.80 kg']","['conventional, dumbbell exercise', 'Dumbbell Exercise', 'experimental exercise conditions: momentum dumbbell and conventional dumbbell']","['hemodynamic responses', 'upper-limb muscle activation measured using surface electromyography (sEMG', 'biceps and triceps brachii', 'cerebral concentrations of oxygenated hemoglobin (HbO 2 ) in the frontal cortex and parietal lobe assessed during performance of both exercises using functional near-infrared spectroscopy (fNIRS', 'Oxygenated Hemodynamic Concentration of Cerebral Activation']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0563597', 'cui_str': 'Momentum'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030069', 'cui_str': 'Oxyhemoglobin'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",22.0,0.0409517,"A significant between-condition difference in HbO 2 was observed in the frontal and parietal regions with an increase in HbO 2 during momentum, relative to conventional, dumbbell exercise ( p < 0.05).","[{'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Lü', 'Affiliation': 'Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Rong', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai First Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Lingyan', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Key Laboratory of Exercise and Health Science of Ministry of Education, Shanghai University of Sport, Shanghai, China.'}]",Frontiers in human neuroscience,['10.3389/fnhum.2020.519171']
2818,33250550,Patch-Based Surface Morphometry Feature Selection with Federated Group Lasso Regression.,"Collectively, vast quantities of brain imaging data exist across hospitals and research institutions, providing valuable resources to study brain disorders such as Alzheimer's disease (AD). However, in practice, putting all these distributed datasets into a centralized platform is infeasible due to patient privacy concerns, data restrictions and legal regulations. In this study, we propose a novel federated feature selection framework that can analyze the data at each individual institution without data-sharing or accessing private patient information. In this framework, we first propose a federated group lasso optimization method based on block coordinate descent. We employ stability selection to determine statistically significant features, by solving the group lasso problem with a sequence of regularization parameters. To accelerate the stability selection, we further propose a federated screening rule, which can identify and exclude the irrelevant features before solving the group lasso. Here, we use this framework for patch based feature selection on hippocampal morphometry. Shape is characterized through two different kinds of local measures, the radial distance and the surface area determined via tensor-based morphometry (TBM). The method is tested on 1,127 T1-weighted brain magnetic resonance images (MRI) of AD, mild cognitive impairment (MCI) and elderly control subjects, randomly assigned to five independent hypothetical institutions for testing purpose. We examine the association of MRI-based anatomical measures with general cognitive assessment and amyloid burden to identify the morphometry changes related to AD deterioration and plaque accumulation. Finally, we visualize the significance of the association on the hippocampal surfaces. Our experimental results successfully demonstrate the efficiency and effectiveness of our method.",2020,"To accelerate the stability selection, we further propose a federated screening rule, which can identify and exclude the irrelevant features before solving the group lasso.","['1,127 T1-weighted brain magnetic resonance images (MRI) of AD, mild cognitive impairment (MCI) and elderly control subjects']",[],[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],[],1127.0,0.0206025,"To accelerate the stability selection, we further propose a federated screening rule, which can identify and exclude the irrelevant features before solving the group lasso.","[{'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'School of Computing, Informatics, and Decision Systems Engineering, Arizona State University, 699 S Mill Ave, Tempe, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'School of Computing, Informatics, and Decision Systems Engineering, Arizona State University, 699 S Mill Ave, Tempe, USA.'}, {'ForeName': 'Qingyang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'School of Computing, Informatics, and Decision Systems Engineering, Arizona State University, 699 S Mill Ave, Tempe, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': ""Banner Alzheimer's Institute, 100 Washtenaw Avenue, Phoenix, USA.""}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': ""Banner Alzheimer's Institute, 100 Washtenaw Avenue, Phoenix, USA.""}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Reiman', 'Affiliation': ""Banner Alzheimer's Institute, 100 Washtenaw Avenue, Phoenix, USA.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Electronic Engineering and Information Science, University of Science and Technology of China, 1129 Huizhou Ave, Baohe District, Hefei, China.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Lepore', 'Affiliation': ""CIBORG Lab, Department of Radiology, Children's Hospital Los Angeles, 4650 Sunset Blvd. MS 81, Los Angeles, USA.""}, {'ForeName': 'Jieping', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Computational Medicine and Bioinformatics, University of Michigan, 1301 Beal Avenue, Ann Arbor, USA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Thompson', 'Affiliation': 'Imaging Genetics Center, Institute for Neuroimaging and Informatics, University of Southern California, 4676 Admiralty Way, Los Angeles, USA.'}, {'ForeName': 'Yalin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Computing, Informatics, and Decision Systems Engineering, Arizona State University, 699 S Mill Ave, Tempe, USA.'}]",Proceedings of SPIE--the International Society for Optical Engineering,['10.1117/12.2575984']
2819,33250456,Effect of an ergonomic intervention involving workstation adjustments on musculoskeletal pain in office workers-a randomized controlled clinical trial.,"Office workers remain in a awkward position for long periods, which can lead to musculoskeletal symptoms. Ergonomic guidelines are recommended to avoid such problems. Evidence of the long-term effectiveness of ergonomic interventions is scarce. The aim of this randomised controlled trial was to compare pain intensity among office workers who received an ergonomic intervention and a control group before as well as 12, 24, and 36 wk after the intervention. Workers were randomly allocated to a control group (CG) and experimental group (EG). The EG received an ergonomic workstation intervention. Furniture measurements were related to individual anthropometric measurements to identify mismatches. The outcome was pain intensity, which was determined using a numerical pain scale and the Nordic Musculoskeletal Questionnaire. A linear mixed model was created with pain intensity as the dependent variable. Group and time were the independent variables. No significant interactions were found between group and time. Significant differences between groups were found for the pain intensity in the neck, shoulder, upper back, and wrist/hand (P<0.05), with lower intensity in the EG. The intervention reduced pain intensity in the neck, shoulder, upper back, and wrist/hand. However, no reduction in pain intensity was found for the lower back or elbow.",2020,"Significant differences between groups were found for the pain intensity in the neck, shoulder, upper back, and wrist/hand (P<0.05), with lower intensity in the EG.",['office workers who received an'],"['ergonomic intervention involving workstation adjustments', 'ergonomic intervention', 'ergonomic interventions', 'control group (CG) and experimental group (EG', 'ergonomic workstation intervention']","['pain intensity, which was determined using a numerical pain scale and the Nordic Musculoskeletal Questionnaire', 'musculoskeletal pain', 'pain intensity in the neck, shoulder, upper back, and wrist/hand', 'pain intensity']","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1736830', 'cui_str': 'Workstation'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0230101', 'cui_str': 'Upper back structure'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",,0.0747125,"Significant differences between groups were found for the pain intensity in the neck, shoulder, upper back, and wrist/hand (P<0.05), with lower intensity in the EG.","[{'ForeName': 'Stefany', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Fernanda Cabegi', 'Initials': 'FC', 'LastName': 'de Barros', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Cristiane Shinohara Moriguchi', 'Initials': 'CSM', 'LastName': 'de Castro', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, Brazil.'}, {'ForeName': 'Tatiana de Oliveira', 'Initials': 'TO', 'LastName': 'Sato', 'Affiliation': 'Department of Physical Therapy, Federal University of São Carlos, Brazil.'}]",Industrial health,['10.2486/indhealth.2020-0188']
2820,33250404,Five-year follow-up of patients with radio-contrast-induced acute renal injury. Can intravenous sodium-bicarbonate improve long-term outcomes?,"BACKGROUND/PURPOSE
Radiocontrast-induced acute kidney injury (RAKI) is a frequent complication during angiography and is associated with adverse prognosis. Most of the studies evaluating the long-term outcome of patients with RAKI are based on institutional registries. This is the first prospective study to evaluate the 5-year outcomes of patients with RAKI, and assess the effect of sodium bicarbonate (SB) in the long-term outcomes of patients with chronic kidney disease (CKD) undergoing non-emergent coronary angiography.
MATERIALS/METHODS
382 CKD stage III-IV patients undergoing elective non-emergent coronary angiography were randomized to SB (n = 192) or normal saline (NS) solution (n = 190). Incidence of RAKI, in-hospital, 1- and 5-year mortality and renal replacement therapy (RRT), and 5-year major adverse renal and cardiovascular events (MARCE) were compared between groups. Outcomes of patient with and without RAKI were compared after five-years of prospective follow-up. Multivariate predictors of RAKI and death at 5-years were determined.
RESULTS
The use of SB did not improve the incidence of RAKI, in-hospital outcomes, survival, and freedom from RRT or MARCE after 5-years of follow-up. Patients that developed RAKI had a significantly higher mortality at 1-year [8.9% Vs. 1.2%] and 5-years (36% Vs. 11%) (P < 0.01).
CONCLUSIONS
Hydration with SB showed no benefit compared to NS in preventing RAKI. The use of SB was not superior to NS after 5-years of follow-up regarding MARCE, survival or freedom of RRT. Five-year mortality among patients who developed RAKI remains high, and further research is needed to find the best preventive strategy for this high-risk group of patients.
SUMMARY
Radiocontrast-induced acute-kidney-injury (RAKI) is associated with poor long-term outcomes in observational and short-term studies. Hydration with sodium bicarbonate (SB) had been evaluated in the prevention of RAKI; but its long-term effect has not been evaluated. We randomized 382 high high-risk patients undergoing coronary angiography to SB or normal saline following them for five years. SB showed no benefit in preventing RAKI, decreasing major adverse renal and cardiovascular events, improving survival or freedom from dialysis after 5-years. This is the first study to follow patients with RAKI for a period of 5-years, showing a significantly higher mortality in this group of patients.",2020,"SB showed no benefit in preventing RAKI, decreasing major adverse renal and cardiovascular events, improving survival or freedom from dialysis after 5-years.","['patients with radio-contrast-induced acute renal injury', '382 high high-risk patients undergoing', 'patients with chronic kidney disease (CKD) undergoing non-emergent coronary angiography', 'patients with RAKI', 'CKD stage III-IV patients undergoing elective non-emergent coronary angiography', '382']","['SB', 'sodium bicarbonate (SB', 'normal saline (NS) solution', 'sodium-bicarbonate', 'coronary angiography to SB or normal saline', 'Radiocontrast']","['RAKI, decreasing major adverse renal and cardiovascular events, improving survival or freedom from dialysis', 'mortality', 'incidence of RAKI, in-hospital outcomes, survival, and freedom from RRT or MARCE', 'Incidence of RAKI, in-hospital, 1- and 5-year mortality and renal replacement therapy (RRT), and 5-year major adverse renal and cardiovascular events (MARCE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C2609414', 'cui_str': 'Acute injury of kidney'}, {'cui': 'C4517750', 'cui_str': '382'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}]",382.0,0.0706832,"SB showed no benefit in preventing RAKI, decreasing major adverse renal and cardiovascular events, improving survival or freedom from dialysis after 5-years.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Boccalandro', 'Affiliation': 'ProCare/Odessa Heart Institute & Permian Research Foundation, Odessa, TX, United States of America; Texas Tech University Health Sciences Center, Department of Internal Medicine, Odessa, TX, United States of America. Electronic address: Fboccalandro@echd.org.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Shreyder', 'Affiliation': 'Lahey Hospital and Medical Center, Department of Cardiovascular Medicine, Tufts University School of Medicine, Burlington, MA, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Harmon', 'Affiliation': 'University of Colorado School of Medicine, Department of Surgery, Denver, CO, United States of America.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Dhindsa', 'Affiliation': 'Community Medical Center, Stockton, CA, United States of America.'}, {'ForeName': 'Tallat', 'Initials': 'T', 'LastName': 'Fahim', 'Affiliation': 'Kaiser Permanente - Bellevue Medical Center. Tacoma, WA, United States of America.'}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Fresenius Medical Center, Inidanapolis, IN, United States of America.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.11.017']
2821,33250152,The perceptual responses of individuals with multiple sclerosis to blood flow restriction versus traditional resistance exercise.,"BACKGROUND
Low-load resistance exercise with blood flow restriction ( LL BFR-RE) has been shown capable of improving neuromuscular parameters in several clinical populations, however, its tolerability and effects on individuals with multiple sclerosis (MS) remains unknown.
OBJECTIVE
To investigate the perceptual responses of individuals with MS to LL BFR-RE versus traditional high-load resistance exercise (HL-RE).
METHODS
Four men and eleven women diagnosed with relapsing-remitting MS randomly completed the following experimental trials: 1) LL BFR-RE four sets of 30-15-15-15 repetitions, at 20% of one-repetition maximum (1-RM) of leg-press (LP) and knee-extension (KE), with 50% of BFR, and a 1-min rest interval between sets; 2) HL-RE- four sets of 8-10 repetitions, at 70% 1-RM of LP and KE, with the same rest intervals. Ratings of perceived exertion (RPE) were measured after each set, pain was measured before and after sets, and delayed-onset muscle soreness (DOMS) was measured at 5, 30, 60 min, and 24-h post-exercise.
RESULTS
HL-RE elicited significantly (p<0.05) greater RPE compared to LL BFR-RE during all sets. Additionally, there were no significant (p>0.05) differences between LL BFR-RE and HL-RE for pain immediately after all sets, although pain measured before sets were significantly (p<0.05) greater for LL BFR-RE. Finally, both protocols resulted in similar DOMS, however, it was significantly (p<0.05) elevated 24-h post-exercise compared to 1-h after for HL-RE but not for LL BFR-RE.
CONCLUSION
Altogether, these data demonstrate that LL BFR-RE is well tolerated by individuals with MS, requires less muscular exertion than HL-RE, and does not cause exaggerated pain during exercise or elevated DOMS up to 24 h post-exercise.",2020,"RESULTS
HL-RE elicited significantly (p<0.05) greater RPE compared to LL BFR-RE during all sets.","['Four men and eleven women diagnosed with relapsing-remitting MS randomly completed the following experimental trials: 1', 'individuals with multiple sclerosis (MS', 'individuals with multiple sclerosis', 'individuals with MS to']","['LL BFR-RE', 'Low-load resistance exercise with blood flow restriction ( LL BFR-RE', 'LL BFR-RE four sets of 30-15-15-15 repetitions, at 20% of one-repetition maximum (1-RM) of leg-press (LP) and knee-extension (KE), with 50% of BFR', 'blood flow restriction versus traditional resistance exercise', 'LL BFR-RE versus traditional high-load resistance exercise (HL-RE']","['LL BFR-RE and HL-RE for pain', 'delayed-onset muscle soreness (DOMS', 'pain', 'Ratings of perceived exertion (RPE']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",4.0,0.0329053,"RESULTS
HL-RE elicited significantly (p<0.05) greater RPE compared to LL BFR-RE during all sets.","[{'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, United States. Electronic address: eduardofreitas@ou.edu.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Rodrigo R', 'Initials': 'RR', 'LastName': 'Aniceto', 'Affiliation': 'Study and Research Group in Biomechanics and Psychophysiology of Exercise, Federal Institute of Education, Science and Technology of Rio Grande do Norte, Currais Novos, RN, Brazil.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Larson', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Hugo M', 'Initials': 'HM', 'LastName': 'Pereira', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, United States.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, University of Oklahoma, Norman, OK, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113219']
2822,33250082,Effects of Netarsudil on the Corneal Endothelium: Three-Month Findings from a Phase 3 Trial.,"PURPOSE
To describe the changes in endothelial cell density (ECD), the coefficient of variation (CV), and the percent of hexagonal cells (%HEX) after 3 months of therapy with netarsudil (Rhopressa; Aerie Pharmaceuticals Inc, Durham, NC) 0.02% dosed once daily (QD) or twice daily (BID) and to compare these changes with those seen with timolol 0.5% BID in eyes with ocular hypertension (OHTN) or open-angle glaucoma (OAG).
DESIGN
Post hoc analysis of data from a phase 3 evaluation of the intraocular pressure (IOP)-lowering efficacy and safety of netarsudil 0.02% versus timolol 0.5%.
PARTICIPANTS
A subset of study subjects underwent corneal endothelial cell imaging by specular microscopy at baseline and after 3 months of therapy.
METHODS
Images were evaluated in a masked fashion at an independent reading center. The ECD, CV, and %HEX were determined using a standardized protocol for image analysis.
MAIN OUTCOME MEASURES
Changes in ECD, CV, and %HEX from baseline to 3 months were compared between treatment groups using 2-sample t tests.
RESULTS
Data from 386 subjects from whom analyzable specular microscopy images were obtained at both baseline and month 3 were included in this analysis. Mean ECD, CV, and %HEX values were comparable between groups at baseline. There were no statistically significant between-group differences in changes from baseline to month 3 in ECD, CV, or %HEX between either of the netarsudil groups and the timolol group. Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all 3 groups by 1.4% to 2.1% (P < 0.001), and %HEX increased by a statistically significant amount (0.7%, P = 0.030) in the timolol group. These small changes were unlikely to be of clinical significance. No statistically significant changes in ECD were seen in any group.
CONCLUSIONS
Netarsudil 0.02% showed no clinically significant effects on ECD, CV, or %HEX when dosed QD or BID for 3 months in eyes with OHTN or OAG.",2020,"Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all 3 groups by 1.4% to 2.1% (P < 0.001), and %HEX increased by a statistically significant amount (0.7%, P = 0.030) in the timolol group.","['Images were evaluated in a masked fashion at an independent reading center', '386 subjects from whom analyzable specular microscopy images', 'eyes with ocular hypertension (OHTN) or open-angle glaucoma (OAG']","['Netarsudil', 'corneal endothelial cell imaging by specular microscopy', 'timolol']","['ECD, CV, or %HEX', 'intraocular pressure (IOP)-lowering efficacy and safety', 'HEX', 'ECD', 'Changes in ECD, CV, and %HEX', 'Mean ECD, CV, and %HEX values', 'endothelial cell density (ECD), the coefficient of variation (CV), and the percent of hexagonal cells (%HEX', 'Corneal Endothelium', 'CV']","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4054002', 'cui_str': 'Specular microscopy'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}]","[{'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C4054002', 'cui_str': 'Specular microscopy'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0014259', 'cui_str': 'Structure of corneal endothelium'}]",386.0,0.119236,"Within groups, CV declined in a statistically significant fashion from baseline to month 3 in all 3 groups by 1.4% to 2.1% (P < 0.001), and %HEX increased by a statistically significant amount (0.7%, P = 0.030) in the timolol group.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mundorf', 'Affiliation': 'Mundorf Eye Center, Charlotte, North Carolina. Electronic address: tommundorf@aol.com.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Mah', 'Affiliation': 'Scripps Clinic, La Jolla, California.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Irvine, California.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc, Irvine, California.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2020.04.014']
2823,33264556,Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results.,"BACKGROUND
World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19).
METHODS
We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.
RESULTS
At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P = 0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P = 0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P = 0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P = 0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.
CONCLUSIONS
These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ISRCTN83971151; ClinicalTrials.gov number, NCT04315948.).",2020,"No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.
","['We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care', 'patients hospitalized with coronavirus disease 2019 (Covid-19', 'At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to']","['hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir', 'hydroxychloroquine', 'hydroxychloroquine, lopinavir', 'hydroxychloroquine, lopinavir, and interferon beta-1a ']","['hospital mortality', 'Kaplan-Meier 28-day mortality', 'Adherence', 'overall mortality, initiation of ventilation, and duration of hospital stay', 'Rate ratios for death', 'reduced initiation of ventilation or hospitalization duration', 'Death']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0254119', 'cui_str': 'Interferon beta-1a'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",11330.0,0.371714,"No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Hongchao', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Peto', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Henao-Restrepo', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Preziosi', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Vasee', 'Initials': 'V', 'LastName': 'Sathiyamoorthy', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Quarraisha', 'Initials': 'Q', 'LastName': 'Abdool Karim', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Marissa M', 'Initials': 'MM', 'LastName': 'Alejandria', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Hernández García', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Kieny', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Malekzadeh', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'K Srinath', 'Initials': 'KS', 'LastName': 'Reddy', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Roses Periago', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Abi Hanna', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ader', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Abdullah M', 'Initials': 'AM', 'LastName': 'Al-Bader', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Almonther', 'Initials': 'A', 'LastName': 'Alhasawi', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Allum', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Athari', 'Initials': 'A', 'LastName': 'Alotaibi', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Alvarez-Moreno', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Appadoo', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Asiri', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Barratt-Due', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Bellani', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Branca', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Heike B C', 'Initials': 'HBC', 'LastName': 'Cappel-Porter', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Nery', 'Initials': 'N', 'LastName': 'Cerrato', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Ting S', 'Initials': 'TS', 'LastName': 'Chow', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Najada', 'Initials': 'N', 'LastName': 'Como', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Eustace', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'García', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Sheela', 'Initials': 'S', 'LastName': 'Godbole', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Gotuzzo', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Laimonas', 'Initials': 'L', 'LastName': 'Griskevicius', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Hamra', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hassany', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hutton', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Irmansyah', 'Initials': 'I', 'LastName': 'Irmansyah', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Ligita', 'Initials': 'L', 'LastName': 'Jancoriene', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kirwan', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lennon', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Lopardo', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lydon', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Magrini', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Maguire', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Manevska', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Manuel', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'McGinty', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Marco T', 'Initials': 'MT', 'LastName': 'Medina', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'María L', 'Initials': 'ML', 'LastName': 'Mesa Rubio', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Miranda-Montoya', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Nel', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Estevao P', 'Initials': 'EP', 'LastName': 'Nunes', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Perola', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Portolés', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Menaldi R', 'Initials': 'MR', 'LastName': 'Rasmin', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Aun', 'Initials': 'A', 'LastName': 'Raza', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Rees', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Paula P S', 'Initials': 'PPS', 'LastName': 'Reges', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Rogers', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Kolawole', 'Initials': 'K', 'LastName': 'Salami', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Marina I', 'Initials': 'MI', 'LastName': 'Salvadori', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Narvina', 'Initials': 'N', 'LastName': 'Sinani', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Jonathan A C', 'Initials': 'JAC', 'LastName': 'Sterne', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Stevanovikj', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Tacconelli', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Kari A O', 'Initials': 'KAO', 'LastName': 'Tikkinen', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Trelle', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Hala', 'Initials': 'H', 'LastName': 'Zaid', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'John-Arne', 'Initials': 'JA', 'LastName': 'Røttingen', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}, {'ForeName': 'Soumya', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'The affiliations of the members of the writing and steering committees are as follows: the Nuffield Department of Population Health and Medical Research Council Population Health Research Unit, University of Oxford, Oxford (H.P., R.P.), and the University of Bristol, Bristol (E.A., S.B., H.B.C.C.-P., D.H., J.K., C.A.R., J.A.C.S.) - both in the United Kingdom; the World Health Organization, Geneva (A.-M.H.-R., M.-P.P., V.S., P. Lydon, M.C.M.-M., K.S., S.S.), the University of Bern, Bern (S.A., M.B., S. McGinty, S.T.), and Lausanne University Hospital, Lausanne (O.M.) - all in Switzerland; the Centre for the AIDS Programme of Research in South Africa, Durban (Q.A.K.), and the University of the Witwatersrand (J.N.) and the Wits Reproductive Health and HIV Institute (H.R.), Johannesburg - all in South Africa; the Institute of National Epidemiology, National Institutes of Health, University of the Philippines, Manila (M.M.A.); the Agency of Medicine and Medical Devices (C.H.G.) and Hospital Clínico San Carlos, Universidad Complutense de Madrid, Spanish Clinical Research Network, Instituto de Investigación Sanitaria San Carlos (A.P.), Madrid; INSERM, Paris (M.-P.K.), and Hospices Civils de Lyon, Lyon (F.A.) - both in France; the Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran (R.M.); the University of British Columbia, Vancouver (S. Murthy), and the Public Health Agency of Canada, Ottawa (M.I.S.) - both in Canada; the Public Health Foundation of India, New Delhi (K.S.R.), and the Indian Council of Medical Research, National AIDS Research Institute, Pune (S.G.) - both in India; the National Academy of Sciences of Buenos Aires (M.R.P.) and Fundación del Centro de Estudios Infectológicos (G.L.), Buenos Aires; Rafic Hariri University Hospital (P.A.H.) and the Ministry of Public Health (R.H.), Beirut, Lebanon; the Ministry of Health (A.M.A.-B.) and Infectious Diseases Hospital (A. Alhasawi), Kuwait City, Kuwait; Universidad Nacional de Colombia and Clinica Colsanitas (C.A.A.-M.) and the Ministry of Health (M.L.M.R.), Bogota, Colombia; the Ministry for Preventive Health, Riyadh, Saudi Arabia (A. Asiri, A. Alotaibi); Oslo University Hospital (P.A., A.B.-D.) and Research Council of Norway (J.-A.R.), Oslo; Secretaria de Salud de Honduras (N. Cerrato) and the National Autonomous University of Honduras (M.T.M.), Tegucigalpa; Penang Hospital, Penang (T.S.C.), and Hospital Sungai Buloh and Jalan Hospital, Selangor (S.K.) - both in Malaysia; University Hospital Center Mother Theresa (N. Como) and the National Agency for Medicines and Medical Devices (N.S.), Tirana, Albania; the HRB Clinical Research Facility, University College Cork, Cork (J.E.), and the Department of Health and Children, Dublin (P. Lennon, T.M.) - both in Ireland; Universidad Peruana Cayetano Heredia, Lima, Peru (P.J.G., E.G.); Vilnius University Hospital Santaros Klinikos (L.G.) and Vilnius University, Institute of Clinical Medicine (L.J.), Vilnius, Lithuania; Shaukat Khanum Memorial Cancer Hospital and Research Center, Lahore, Pakistan (M. Hassan, A.R.); the National Hepatology and Tropical Medicine Research Institute (M. Hassany) and the Ministry of Health and Population (H.Z.), Cairo; the National Institute of Health Research and Development (I.I.) and Rumah Sakit Umum Pusat Persahabatan (M.R.R.), Jakarta, Indonesia; the Italian Medicines Agency, Rome (N.M.), and the University of Verona, Verona (E.T.) - both in Italy; the Ministry of Health (S. Manevska) and the University Clinic of Infectious Diseases and Febrile Conditions (M.S.), Skopje, North Macedonia; the Oswaldo Cruz Foundation, Rio de Janeiro (E.P.N., P.P.S.R.); and the Finnish Institute for Health and Welfare and the University of Finland (M.P.) and Helsinki University Hospital (K.A.O.T.), Helsinki, and South Karelian Central Hospital, Lappeenranta (K.A.O.T.) - all in Finland.'}]",The New England journal of medicine,['10.1056/NEJMoa2023184']
2824,33264544,Pembrolizumab in Microsatellite-Instability-High Advanced Colorectal Cancer.,"BACKGROUND
Programmed death 1 (PD-1) blockade has clinical benefit in microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) tumors after previous therapy. The efficacy of PD-1 blockade as compared with chemotherapy as first-line therapy for MSI-H-dMMR advanced or metastatic colorectal cancer is unknown.
METHODS
In this phase 3, open-label trial, 307 patients with metastatic MSI-H-dMMR colorectal cancer who had not previously received treatment were randomly assigned, in a 1:1 ratio, to receive pembrolizumab at a dose of 200 mg every 3 weeks or chemotherapy (5-fluorouracil-based therapy with or without bevacizumab or cetuximab) every 2 weeks. Patients receiving chemotherapy could cross over to pembrolizumab therapy after disease progression. The two primary end points were progression-free survival and overall survival.
RESULTS
At the second interim analysis, after a median follow-up (from randomization to data cutoff) of 32.4 months (range, 24.0 to 48.3), pembrolizumab was superior to chemotherapy with respect to progression-free survival (median, 16.5 vs. 8.2 months; hazard ratio, 0.60; 95% confidence interval [CI], 0.45 to 0.80; P = 0.0002). The estimated restricted mean survival after 24 months of follow-up was 13.7 months (range, 12.0 to 15.4) as compared with 10.8 months (range, 9.4 to 12.2). As of the data cutoff date, 56 patients in the pembrolizumab group and 69 in the chemotherapy group had died. Data on overall survival were still evolving (66% of required events had occurred) and remain blinded until the final analysis. An overall response (complete or partial response), as evaluated with Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, was observed in 43.8% of the patients in the pembrolizumab group and 33.1% in the chemotherapy group. Among patients with an overall response, 83% in the pembrolizumab group, as compared with 35% of patients in the chemotherapy group, had ongoing responses at 24 months. Treatment-related adverse events of grade 3 or higher occurred in 22% of the patients in the pembrolizumab group, as compared with 66% (including one patient who died) in the chemotherapy group.
CONCLUSIONS
Pembrolizumab led to significantly longer progression-free survival than chemotherapy when received as first-line therapy for MSI-H-dMMR metastatic colorectal cancer, with fewer treatment-related adverse events. (Funded by Merck Sharp and Dohme and by Stand Up to Cancer; KEYNOTE-177 ClinicalTrials.gov number, NCT02563002.).",2020,Data on overall survival were still evolving (66% of required events had occurred) and remain blinded until the final analysis.,"['MSI-H-dMMR advanced or metastatic colorectal cancer', '56 patients in the pembrolizumab group and 69 in the', '307 patients with metastatic MSI-H-dMMR colorectal cancer who had not previously received treatment', 'Microsatellite-Instability-High Advanced Colorectal Cancer']","['pembrolizumab at a dose of 200 mg every 3 weeks or chemotherapy (5-fluorouracil-based therapy with or without bevacizumab or cetuximab', 'Pembrolizumab', 'PD-1 blockade', 'pembrolizumab', 'chemotherapy', 'pembrolizumab therapy']","['died', 'progression-free survival', 'mean survival', 'overall response (complete or partial response', 'progression-free survival and overall survival', 'overall survival']","[{'cui': 'C0796369', 'cui_str': 'Microsatellite instability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4544822', 'cui_str': 'Microsatellite instability-high colorectal cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",307.0,0.207067,Data on overall survival were still evolving (66% of required events had occurred) and remain blinded until the final analysis.,"[{'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'André', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Kai-Keen', 'Initials': 'KK', 'LastName': 'Shiu', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Benny Vittrup', 'Initials': 'BV', 'LastName': 'Jensen', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Lars Henrik', 'Initials': 'LH', 'LastName': 'Jensen', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Punt', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Smith', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Garcia-Carbonero', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Benavides', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'de la Fouchardiere', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Elez', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Yoshino', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Mohammed Z H', 'Initials': 'MZH', 'LastName': 'Farooqui', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marinello', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Diaz', 'Affiliation': ""From Sorbonne Université and Hôpital Saint Antoine, Paris (T.A.), Bordeaux University Hospital, Bordeaux (D.S.), and Léon Bérard Center, Lyon (C.F.) - all in France; University College Hospital, NHS Foundation Trust, London (K.-K.S.); Asan Medical Center, University of Ulsan, Seoul, South Korea (T.W.K.); Herlev and Gentofte Hospital, Herlev (B.V.J.), and University Hospital of Southern Denmark, Vejle (L.H.J.) - both in Denmark; Amsterdam University Medical Center, University of Amsterdam, Amsterdam (C.P.); Hospital Universitario 12 de Octubre, Imas12, Madrid (R.G.-C.), Hospital Regional Universitario, Malaga (M.B.), Hospital Universitario Marques de Valdecilla, Santander (F.R.), and Vall d'Hebron Institute of Oncology, Barcelona (E.E.) - all in Spain; Western Health, St. Albans, VIC, Australia (P.G.); Sarah Cannon Research Institute-Tennessee Oncology, Nashville (J.B.); Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (D.T.L.); National Cancer Center Hospital East, Kashiwa, Japan (T.Y.); University Hospital Gasthuisberg and KU Leuven, Leuven, Belgium (E.V.C.); MSD China, Beijing (P.Y.); Merck, Kenilworth, NJ (M.Z.H.F., P.M.); and Memorial Sloan Kettering Cancer Center, New York (L.A.D.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2017699']
2825,33264546,Malaria Chemoprevention in the Postdischarge Management of Severe Anemia.,"BACKGROUND
Children who have been hospitalized with severe anemia in areas of Africa in which malaria is endemic have a high risk of readmission and death within 6 months after discharge. No prevention strategy specifically addresses this period.
METHODS
We conducted a multicenter, two-group, randomized, placebo-controlled trial in nine hospitals in Kenya and Uganda to determine whether 3 months of malaria chemoprevention could reduce morbidity and mortality after hospital discharge in children younger than 5 years of age who had been admitted with severe anemia. All children received standard in-hospital care for severe anemia and a 3-day course of artemether-lumefantrine at discharge. Two weeks after discharge, children were randomly assigned to receive dihydroartemisinin-piperaquine (chemoprevention group) or placebo, administered as 3-day courses at 2, 6, and 10 weeks after discharge. Children were followed for 26 weeks after discharge. The primary outcome was one or more hospital readmissions for any reason or death from the time of randomization to 6 months after discharge. Conditional risk-set modeling for recurrent events was used to calculate hazard ratios with the use of the Prentice-Williams-Peterson total-time approach.
RESULTS
From May 2016 through May 2018, a total of 1049 children underwent randomization; 524 were assigned to the chemoprevention group and 525 to the placebo group. From week 3 through week 26, a total of 184 events of readmission or death occurred in the chemoprevention group and 316 occurred in the placebo group (hazard ratio, 0.65; 95% confidence interval [CI], 0.54 to 0.78; P<0.001). The lower incidence of readmission or death in the chemoprevention group than in the placebo group was restricted to the intervention period (week 3 through week 14) (hazard ratio, 0.30; 95% CI, 0.22 to 0.42) and was not sustained after that time (week 15 through week 26) (hazard ratio, 1.13; 95% CI, 0.87 to 1.47). No serious adverse events were attributed to dihydroartemisinin-piperaquine.
CONCLUSIONS
In areas with intense malaria transmission, 3 months of postdischarge malaria chemoprevention with monthly dihydroartemisinin-piperaquine in children who had recently received treatment for severe anemia prevented more deaths or readmissions for any reason after discharge than placebo. (Funded by the Research Council of Norway and the Centers for Disease Control and Prevention; ClinicalTrials.gov number, NCT02671175.).",2020,"The lower incidence of readmission or death in the chemoprevention group than in the placebo group was restricted to the intervention period (week 3 through week 14) (hazard ratio, 0.30; 95% CI, 0.22 to 0.42) and was not sustained after that time (week 15 through week 26) (hazard ratio, 1.13; 95% CI, 0.87 to 1.47).","['All children received standard in-hospital care for severe anemia and a 3-day course of artemether-lumefantrine at discharge', 'nine hospitals in Kenya and Uganda', 'children younger than 5 years of age who had been admitted with severe anemia', 'Severe Anemia', 'From May 2016 through May 2018, a total of 1049 children underwent randomization; 524 were assigned to the chemoprevention group and 525 to the', 'Children who have been hospitalized with severe anemia in areas of Africa in which malaria']","['placebo', 'dihydroartemisinin-piperaquine (chemoprevention group) or placebo']","['morbidity and mortality', 'serious adverse events', 'hospital readmissions for any reason or death from the time of randomization to 6 months after discharge', 'deaths or readmissions', 'readmission or death']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0936150', 'cui_str': 'artemether and lumefantrine'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",1049.0,0.675149,"The lower incidence of readmission or death in the chemoprevention group than in the placebo group was restricted to the intervention period (week 3 through week 14) (hazard ratio, 0.30; 95% CI, 0.22 to 0.42) and was not sustained after that time (week 15 through week 26) (hazard ratio, 1.13; 95% CI, 0.87 to 1.47).","[{'ForeName': 'Titus K', 'Initials': 'TK', 'LastName': 'Kwambai', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Aggrey', 'Initials': 'A', 'LastName': 'Dhabangi', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Idro', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Opoka', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Watson', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Nickline A', 'Initials': 'NA', 'LastName': 'Kuya', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Onyango', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Kephas', 'Initials': 'K', 'LastName': 'Otieno', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Samuels', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Meghna R', 'Initials': 'MR', 'LastName': 'Desai', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Boele van Hensbroek', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Robberstad', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Kamija S', 'Initials': 'KS', 'LastName': 'Phiri', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}, {'ForeName': 'Feiko O', 'Initials': 'FO', 'LastName': 'Ter Kuile', 'Affiliation': ""From the Centre for Global Health Research, Kenya Medical Research Institute (T.K.K., S.K., N.A.K., E.D.O., K.O., F.O.K.), and the Kisumu County Department of Health, Kenya Ministry of Health (T.K.K.) and the Division of Parasitic Diseases and Malaria, Centers for Disease Control and Prevention (CDC) (A.M.S., M.R.D.) - all in Kisumu; the Department of Clinical Sciences, Liverpool School of Tropical Medicine (T.K.K., V.W., D.W., F.O.K.), and the Department of Biostatistics, University of Liverpool (V.W.), Liverpool, United Kingdom; Makerere University College of Health Sciences, Kampala, Uganda (A.D., R.I., R.O.); the Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, Atlanta (A.M.S., M.R.D.); Emma Children's Hospital, Academic Medical Center, University of Amsterdam, Amsterdam (M.B.H.); the Ryan White Center for Pediatric Infectious Disease and Global Health, Indiana University School of Medicine, Indianapolis (C.C.J.); the Section for Ethics and Health Economics and the Center for International Health, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway (B.R.); and the School of Public Health and Family Medicine, College of Medicine, University of Malawi, Blantyre (K.S.P.).""}]",The New England journal of medicine,['10.1056/NEJMoa2002820']
2826,33249884,Cardiovascular disease risk factors and health behaviors of ultra-Orthodox Jewish women in Israel: a comparison study.,"OBJECTIVES
Women from low socio-economic, culturally insular populations are at increased risk for cardiovascular disease (CVD). The ultra-Orthodox Jewish (UOJ) community in Israel is a rapidly growing low socio-economic, insular, cultural-ethnic minority with numerous obstacles to health. The current cross-sectional study investigates CVD-related health behaviors and risk factors in a sample of UOJ females, comparing sample characteristics with the general population. Design: Self-administered questionnaires completed by a cluster randomized sample of 239 UOJ women included demographics, CVD-related health behaviors (consumption of fruit, vegetables, and sweetened beverages; hours of sleep; secondhand smoke exposure; and physical activity engagement) and risk factors (BMI, reported diagnoses of diabetes, high blood pressure, and heart disease). Results: Compared with the general population, UOJ women were less likely to consume 5 fruits and vegetables a day (12.7% vs. 24.3%, p < .001); more likely to consume ≥ 5 cups of sweetened beverages a week (18.6% vs. 12.6%, p = .019), and more likely to sleep <7 hours a night (62.0% vs. 50.6%, p = .002). UOJ women also reported less secondhand smoke exposure (7.2% vs. 51.4%, p < .001) and higher rates of physical activity recommendation adherence (60.1% vs. 25.6%, p < .0001) than the general population. Obesity was higher in UOJ women (24.3% vs. 16.1%, p < .0001). Increased parity and reduced moderate physical activity were associated with increased BMI. Increased parity was also associated with reduced sleep. Grand multiparous women (a 68% prevalence rate), in particular, were more likely to be overweight or obese than women with less than 5 children. Conclusions: This study suggests that health promotion interventions in this population target healthy weight maintenance, nutrition, and physical activity.",2020,"Obesity was higher in UOJ women (24.3% vs. 16.1%, p < .0001).","['239 UOJ women included demographics, CVD-related health behaviors (consumption of fruit, vegetables, and sweetened beverages; hours of sleep; secondhand smoke exposure; and', 'ultra-Orthodox Jewish women in Israel', 'Grand multiparous women (a 68% prevalence rate), in particular, were more likely to be overweight or obese than women with less than 5 children']",['health promotion interventions'],"['physical activity engagement) and risk factors (BMI, reported diagnoses of diabetes, high blood pressure, and heart disease', 'Cardiovascular disease risk factors and health behaviors', 'BMI', 'physical activity recommendation adherence', 'moderate physical activity', 'secondhand smoke exposure', 'reduced sleep', 'Obesity']","[{'cui': 'C0022422', 'cui_str': 'Judaism'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",239.0,0.053537,"Obesity was higher in UOJ women (24.3% vs. 16.1%, p < .0001).","[{'ForeName': 'Elisheva', 'Initials': 'E', 'LastName': 'Leiter', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Cardiology Department, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Keren L', 'Initials': 'KL', 'LastName': 'Greenberg', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Cardiology Department, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Milka', 'Initials': 'M', 'LastName': 'Donchin', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Cardiology Department, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Osnat', 'Initials': 'O', 'LastName': 'Keidar', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Cardiology Department, Hadassah University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Siemiatycki', 'Affiliation': ""Bishvilaych, The Evelyne Barnett Women's Medical Center, Jerusalem, Israel.""}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Zwas', 'Affiliation': 'Linda Joy Pollin Cardiovascular Wellness Center for Women, Cardiology Department, Hadassah University Medical Center, Jerusalem, Israel.'}]",Ethnicity & health,['10.1080/13557858.2020.1849567']
2827,33249877,Intermittent Pneumatic Compression of the Upper Extremity for Postoperative Deep Venous Thrombosis Prophylaxis: A Pilot Randomized Trial.,,2020,,[],['Intermittent Pneumatic Compression of the Upper Extremity'],[],[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}]",[],,0.0328249,,"[{'ForeName': 'Preeti R', 'Initials': 'PR', 'LastName': 'John', 'Affiliation': 'Department of Surgery, 12264VA Maryland Healthcare System and University of Maryland School of Medicine, MD, USA.'}, {'ForeName': 'Otis S', 'Initials': 'OS', 'LastName': 'Apau', 'Affiliation': 'Department of Internal Medicine, 158158Meharry Medical College, TN, USA.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Dosi', 'Affiliation': ""Department of Surgery, 483907Brigham and Women's Hospital, MA, USA.""}, {'ForeName': 'Brajesh K', 'Initials': 'BK', 'LastName': 'Lal', 'Affiliation': 'Department of Surgery, 12264VA Maryland Healthcare System and University of Maryland School of Medicine, MD, USA.'}]",The American surgeon,['10.1177/0003134820954823']
2828,33249812,[Effects of mobile health intervention on early knee function after anterior cruciate ligament reconstruction: a prospective randomized controlled study].,"Objective: To investigate the early clinical effects of home-based mobile health intervention on knee joint function after anterior cruciate ligament (ACL) reconstruction. Methods: This was a prospective randomized controlled trial. Patients undergoing arthroscopic ACL reconstruction alone at the Institute of Sports Medicine, Peking University Third Hospital from April 2019 to December 2019 were elected in the trial. Patients were divided into the intervention group and the control group according to random number method. The control group only received the guidance of the traditional paper rehabilitation schedule, while the intervention group also received personalized guidance of electronic rehabilitation prescription and follow-up notice delivered by a WeChat Mini Program Rehabilitation Cloud Platform in addition to the traditional guidance. Joint range of motion (ROM), visual analogue scale (VAS) and thigh circumference difference were assessed before and after the operation. Independent sample t test or Mann-Whitney U test was used for comparison of data between groups, and chi-square test was used for comparison of enumeration data. Results: One hundred and twenty five patients were enrolled in the trial, including 99 males and 26 females, with an average age of 29.0 years (range:18 to 45 years) and an average body mass index of 24.8 kg/m(2) (range:15.8 to 36.6 kg/m(2)). At 6 weeks, follow-up was available in 106 cases the target-reach rate of ROM in control group was 42.6%(23/54), which was 67.3%(35/52) in the intervention group, the difference was statistically significant (χ(2)=6.53, P= 0.01); VAS of the intervention group was 2.5(2.0), lower than that of the control group 3.0(2.0)( M ( Q(R) )), the difference was statistically significant ( Z= -2.06, P= 0.04); And the thigh circumference difference of the intervention group was 2.0(2.0)cm lower than that of the control group 3.0(1.8)cm, the difference was statistically significant ( Z=- 3.00, P< 0.01). Conclusion: Mobile health intervention can improve the early postoperative rehabilitation effect after ACL construction and the ROM of the knee joint, and reduce the bent-knee pain along with the thigh circumference difference.",2020,"Joint range of motion (ROM), visual analogue scale (VAS) and thigh circumference difference were assessed before and after the operation.","['early knee function after anterior cruciate ligament reconstruction', 'anterior cruciate ligament (ACL) reconstruction', 'Patients undergoing arthroscopic ACL reconstruction alone at the Institute of Sports Medicine, Peking University Third Hospital from April 2019 to December 2019 were elected in the trial', 'One hundred and twenty five patients were enrolled in the trial, including 99 males and 26 females, with an average age of 29.0 years (range:18 to 45 years) and an average body mass index of 24.8 kg/m(2) (range:15.8 to 36.6 kg/m(2']","['guidance of the traditional paper rehabilitation schedule, while the intervention group also received personalized guidance of electronic rehabilitation prescription and follow-up notice delivered by a WeChat Mini Program Rehabilitation Cloud Platform in addition to the traditional guidance', 'Mobile health intervention', 'mobile health intervention', 'home-based mobile health intervention']","['knee joint function', 'thigh circumference difference', 'Joint range of motion (ROM), visual analogue scale (VAS) and thigh circumference difference', ' M ( Q(R) ']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",125.0,0.0330782,"Joint range of motion (ROM), visual analogue scale (VAS) and thigh circumference difference were assessed before and after the operation.","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Social Medicine and Health Education, Peking University, Beijing 100191, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Social Medicine and Health Education, Peking University, Beijing 100191, China.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Chu', 'Affiliation': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Sun', 'Affiliation': 'Department of Social Medicine and Health Education, Peking University, Beijing 100191, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Yang', 'Affiliation': 'Institute of Sports Medicine, Peking University Third Hospital, Beijing 100191, China.'}]",Zhonghua wai ke za zhi [Chinese journal of surgery],['10.3760/cma.j.cn112139-20200723-00575']
2829,33249810,[Application of autologous platelet-rich plasma separation in cardiac valve replacement: a random clinical trial].,"Objective: To examine the blood protective effect of autologous platelet-rich plasma separation for cardiac valve replacement under cardiopulmonary bypass. Methods: Sixty patients who underwent cardiac valve replacement under cardiopulmonary bypass from August 2018 to May 2019 in Shanghai Chest Hospital, Shanghai Jiao Tong University were randomly divided into control and treatment groups(each 30 cases). There were 33 males and 27 females, aged (52.0±8.4) years (range: 35 to 65 years). Autologous platelet separation was performed in the treatment group after anaesthesia administration and was completed before systemic heparinisation. Platelet separation was not performed in the control group. The thromboelastogram, blood routine, blood coagulation, perioperative fluid infusion, allogeneic blood transfusion, postoperative pleural fluid volume and postoperative fibrinogen were recorded before the operation, and 1 hour and 24 hours post operation. The two groups' data was compared by t test, Kruskal-Wallis test, Mann-Whitney U test or χ(2) test. Repeated measurement analysis of variance was used to compare platelet and coagulation indexes at different times. Results: The perioperative red blood cell transfusion of 0, 1~2, 3~4,>4 units with 6, 11, 1, 12 cases in treatment group and 14, 8, 6, 2 cases in control group ( Z= -2.516, P= 0.012). The postoperative fibrinogen of 0, 1, 2 units with 19, 2, 9 cases in treat group and 26, 2, 2 cases in control group ( Z= -2.190, P= 0.029). There was no significant difference in the cost of blood transfusion between the two groups during admission ((1 732±1 275) yuan vs . (1 176±941) yuan; t= -1.570, P= 0.125). Conclusion: The use of autologous platelet-rich plasma separation can reduce the amount of allogeneic blood transfusion during valvular surgery under cardiopulmonary bypass.",2020,There was no significant difference in the cost of blood transfusion between the two groups during admission ((1 732±1 275) yuan vs .,"['cardiac valve replacement', 'valvular surgery under cardiopulmonary bypass', '33 males and 27 females, aged (52.0±8.4) years (range: 35 to 65 years', 'cardiac valve replacement under cardiopulmonary bypass', 'Sixty patients who underwent cardiac valve replacement under cardiopulmonary bypass from August 2018 to May 2019 in Shanghai Chest Hospital, Shanghai Jiao Tong University']",['autologous platelet-rich plasma separation'],"['Platelet separation', 'postoperative fibrinogen', 'Autologous platelet separation', 'perioperative red blood cell transfusion', 'allogeneic blood transfusion', 'thromboelastogram, blood routine, blood coagulation, perioperative fluid infusion, allogeneic blood transfusion, postoperative pleural fluid volume and postoperative fibrinogen', 'cost of blood transfusion', 'platelet and coagulation indexes']","[{'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0183964', 'cui_str': 'Tong'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0036679', 'cui_str': 'Separation'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0040017', 'cui_str': 'Thromboelastography'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0225778', 'cui_str': 'Pleural fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0201817,There was no significant difference in the cost of blood transfusion between the two groups during admission ((1 732±1 275) yuan vs .,"[{'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiac Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiac Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiac Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiac Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai 200030, China.'}]",Zhonghua wai ke za zhi [Chinese journal of surgery],['10.3760/cma.j.cn112139-20191231-00647']
2830,33249449,Additive Analgesic Effect of Transcranial Direct Current Stimulation Together with Mirror Therapy for the Treatment of Phantom Pain.,"OBJECTIVE
Current analgesic treatments for phantom pain are not optimal. One well-accepted yet limited nonpharmacological option is mirror therapy, which is thought to counterbalance abnormal plasticity. Transcranial direct current stimulation (tDCS) is an emerging approach believed to affect the membrane potential and activity threshold of cortical neurons. tDCS analgesic effectiveness, however, is mild and short, rendering it a noneffective stand-alone treatment. This study aimed to assess if a combination of mirror therapy with tDCS results in a superior analgesic effect as compared with mirror therapy alone in patients suffering from phantom pain due to recent amputation.
DESIGN
Following ethical approval, eligible patients provided informed consent and were randomly assigned to a study treatment group that continued for 2 weeks (once daily): 1) mirror therapy; 2) mirror therapy and sham tDCS; or 3) mirror therapy and tDCS. Assessments were done before treatment; at the end of treatment weeks 1 and 2; and at 1 week, 1 month, and 3 months following treatment. The primary outcome measure was pain intensity. Secondary measures were derived from the Short Form McGill Pain Questionnaire and the Brief Pain Inventory.
RESULTS
Thirty patients were recruited, and 29 patients completed the study. Three months following treatment, pain intensity was significantly (P<0.001) reduced in the combined treatment group (reduction of 5.4±3.3 points) compared with the other study arms (mirror therapy, 1.2±1.1; mirror therapy and sham tDCS, 2.7±3.2). All secondary outcome results were in line with these findings.
CONCLUSIONS
Combining tDCS with mirror therapy results in a robust long-lasting analgesic effect. These encouraging findings may contribute to the understanding of the underlying mechanisms of phantom pain.",2020,"Three months following treatment, pain intensity was significantly (P<0.001) reduced in the combined treatment group (reduction of 5.4±3.3 points) compared with the other study arms (mirror therapy, 1.2±1.1; mirror therapy and sham tDCS, 2.7±3.2).","['Thirty patients were recruited, and 29 patients completed the study', 'patients suffering from phantom pain due to recent amputation']","['mirror therapy with tDCS', 'Transcranial direct current stimulation (tDCS', 'Transcranial Direct Current Stimulation', 'mirror therapy and sham tDCS; or 3) mirror therapy and tDCS', 'Mirror Therapy']","['tDCS analgesic effectiveness', 'pain intensity', 'Short Form McGill Pain Questionnaire and the Brief Pain Inventory']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031315', 'cui_str': 'Phantom limb'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",30.0,0.0703907,"Three months following treatment, pain intensity was significantly (P<0.001) reduced in the combined treatment group (reduction of 5.4±3.3 points) compared with the other study arms (mirror therapy, 1.2±1.1; mirror therapy and sham tDCS, 2.7±3.2).","[{'ForeName': 'Nitza', 'Initials': 'N', 'LastName': 'Segal', 'Affiliation': ""Orthopedic Rehabilitation Department, Loewenstein Hospital, Ra'anana, Israel.""}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Pud', 'Affiliation': 'Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Amir', 'Affiliation': ""Orthopedic Rehabilitation Department, Loewenstein Hospital, Ra'anana, Israel.""}, {'ForeName': 'Motti', 'Initials': 'M', 'LastName': 'Ratmansky', 'Affiliation': 'Pain Clinic, Sheba Medical Center, Tel HaShomer, Ramat-Gan, Israel.'}, {'ForeName': 'Pora', 'Initials': 'P', 'LastName': 'Kuperman', 'Affiliation': 'Clinical Pain Innovation Lab, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Honigman', 'Affiliation': 'Clinical Pain Innovation Lab, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Roi', 'Initials': 'R', 'LastName': 'Treister', 'Affiliation': 'Clinical Pain Innovation Lab, University of Haifa, Haifa, Israel.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa388']
2831,33249347,Exercise with TENS does not augment gains in balance and strength for dancers.,"Electrical stimulation modulates sensory feedback and improves motor performance, at least for individuals with compromised sensorimotor function. The purpose of this study was to determine the effectiveness of a 4-wk intervention with transcutaneous electrical nerve stimulation (TENS) at improving strength and balance in dancers. Nineteen dancers completed a timed, single-leg balance test, the Y-balance test, and contractions with the hip flexor and knee extensor muscles to assess maximal strength and force steadiness. They completed 4-wks of moderate-intensity bodyweight exercises (3x/wk) and were pseudo-randomized to either a Treatment or Sham group in a single-blind design. The Treatment group received constant TENS over the hamstring muscles during the exercises, whereas the Sham group was exposed to a brief TENS current. The data were pooled due to few significant between-group differences from before to after the intervention. Most outcome measures significantly improved: hip extensor muscles were stronger (P ≤ 0.01), time stood on a single-leg with eyes closed increased (P = 0.02), and the distance reached during the Y-balance test increased (P ≤ 0.001). The improvement in scores on the Y-balance test exceeded the minimal clinically significant change. Twelve sessions of moderate-intensity bodyweight exercises improved muscle strength and balance in experienced dancers. The addition of TENS, however, did not augment the gains in function.",2020,"Most outcome measures significantly improved: hip extensor muscles were stronger (P ≤ 0.01), time stood on a single-leg with eyes closed increased (P = 0.02), and the distance reached during the Y-balance test increased (P ≤ 0.001).",['individuals with compromised sensorimotor function'],"['Electrical stimulation', 'constant TENS', 'Exercise with TENS', '4-wk intervention with transcutaneous electrical nerve stimulation (TENS']","['time stood on a single-leg with eyes closed', 'balance and strength for dancers', 'muscle strength and balance', ' hip extensor muscles', 'motor performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0589515', 'cui_str': 'Sensorimotor functions'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0335081', 'cui_str': 'Dancer'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",19.0,0.0203874,"Most outcome measures significantly improved: hip extensor muscles were stronger (P ≤ 0.01), time stood on a single-leg with eyes closed increased (P = 0.02), and the distance reached during the Y-balance test increased (P ≤ 0.001).","[{'ForeName': 'Leah A', 'Initials': 'LA', 'LastName': 'Davis', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA. Electronic address: leah.davis@colorado.edu.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Carzoli', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Kaltrina', 'Initials': 'K', 'LastName': 'Feka', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA; Health Promotion and Cognitive Sciences, Department of Psychology, Educational Science and Human Movement, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Nelson', 'Affiliation': 'Department of Theater and Dance, University of Colorado Boulder, Boulder, CO, USA.'}, {'ForeName': 'Roger M', 'Initials': 'RM', 'LastName': 'Enoka', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder, Boulder, CO, USA.'}]",Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology,['10.1016/j.jelekin.2020.102507']
2832,33249321,Effects of monthly intravenous ibandronate on bone mineral density and microstructure in patients with primary osteoporosis after teriparatide treatment: the MONUMENT study.,"PURPOSE
To investigate the effects of sequential therapy with monthly intravenous ibandronate on bone mineral density (BMD) and microstructure in patients with primary osteoporosis who received teriparatide treatment.
METHODS
Sixty-six patients with primary osteoporosis who had undergone teriparatide treatment for more than 12 months (mean 18.6 months) received sequential therapy with 1 mg/month intravenous ibandronate for 12 months. The patients were evaluated using dual-energy X-ray absorptiometry (DXA), quantitative ultrasound, bone turnover markers, and high-resolution peripheral quantitative computed tomography (HR-pQCT) at baseline and 6 and 12 months after beginning administration.
RESULTS
At 12 months after beginning sequential therapy, the bone resorption marker, tartrate-resistant acid phosphatase-5b, decreased by 39.5%, with 82.3% of the patients exhibiting levels within the normal limit. DXA revealed that the BMD of the lumbar spine increased by 3.2%, with 79.0% of the patients exhibiting a response, and 40.3% experiencing an increase in BMD over 5%. HR-pQCT revealed that the cortical thickness of the distal tibia was increased by 2.6%. The cortical area increased by 2.5%, and the buckling ratio (an index of cortical instability) decreased by 2.5%. Most parameters of the trabecular bone showed no significant changes. These changes in the cortical bone were observed in both the distal radius and tibia and appeared beginning 6 months after treatment initiation.
CONCLUSIONS
Sequential therapy with monthly intravenous ibandronate increased the BMD and improved the cortical bone microstructure of osteoporotic patients who had undergone teriparatide treatment.",2020,"These changes in the cortical bone were observed in both the distal radius and tibia and appeared beginning 6 months after treatment initiation.
","['patients with primary osteoporosis who received teriparatide treatment', 'osteoporotic patients who had undergone teriparatide treatment', 'patients with primary osteoporosis after teriparatide treatment', 'Sixty-six patients with primary osteoporosis who had undergone teriparatide treatment for more than 12 months (mean 18.6 months) received']","['intravenous ibandronate', 'DXA', 'sequential therapy with 1 mg/month intravenous ibandronate']","['BMD of the lumbar spine', 'BMD', 'buckling ratio (an index of cortical instability', 'cortical bone', 'cortical thickness of the distal tibia', 'cortical bone microstructure', 'bone mineral density (BMD', 'bone resorption marker, tartrate-resistant acid phosphatase-5b', 'cortical area', 'bone mineral density and microstructure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0379199', 'cui_str': 'Ibandronate'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0231748', 'cui_str': 'Giving-way'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0222652', 'cui_str': 'Cortex of bone'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0588200', 'cui_str': 'Bone structure of distal tibia'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",66.0,0.0173196,"These changes in the cortical bone were observed in both the distal radius and tibia and appeared beginning 6 months after treatment initiation.
","[{'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Chiba', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan. Electronic address: kohchiba@estate.ocn.ne.jp.'}, {'ForeName': 'Shuta', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Itaru', 'Initials': 'I', 'LastName': 'Yoda', 'Affiliation': 'Juko Memorial Nagasaki Hospital, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Era', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Yokota', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Narihiro', 'Initials': 'N', 'LastName': 'Okazaki', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Ota', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Yusaku', 'Initials': 'Y', 'LastName': 'Isobe', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Satsuki', 'Initials': 'S', 'LastName': 'Miyazaki', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Tashiro', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Nakashima', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Morimoto', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Japan.'}, {'ForeName': 'Tomoo', 'Initials': 'T', 'LastName': 'Tsukazaki', 'Affiliation': 'Tsukazaki Orthopedic Clinic, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Watanabe Orthopedic Clinic, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Enomoto', 'Affiliation': 'Enomoto Orthopedic Clinic, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yabe', 'Affiliation': 'Juko Memorial Nagasaki Hospital, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Yonekura', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'The Open University of Japan, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Osaki', 'Affiliation': 'Department of Orthopedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Japan.'}]",Bone,['10.1016/j.bone.2020.115770']
2833,33243246,"The effect of a school-based intervention on physical activity, cardiorespiratory fitness and muscle strength: the School in Motion cluster randomized trial.","BACKGROUND
Physical activity (PA) declines throughout adolescence, therefore PA promotion during this period is important. We analyzed the effect of two school-based PA interventions on daily PA levels, cardiorespiratory fitness (CRF) and muscle strength among adolescents.
METHODS
For the nine-month School in Motion intervention study (ScIM), we cluster-randomized 30 Norwegian secondary schools (N = 2084, mean age [SD] = 14 [0.3] years) to one of three study arms. The physically active learning (PAL) intervention included 30 min physically active learning, 30 min PA and a 60 min physical education (PE) lesson per week. The Don't worry-Be happy (DWBH) intervention included a 60 min PA lesson and a 60 min PE lesson per week, both tailored to promote friendships and wellbeing. Both intervention arms were designed to engage the adolescents in 120 min of PA per week in addition to recess and mandatory PE lessons. The control group continued as per usual, including the standard amount of mandatory PE. PA (main outcome) was assessed by accelerometers, CRF and muscle strength (secondary outcomes) were assessed by an intermittent running test and selected tests from the Eurofit test battery.
RESULTS
Daily PA and time spent in moderate- to vigorous-intensity PA (MVPA) decreased in all groups throughout the intervention. The mean difference in PA level and MVPA for participants in the PAL-intervention arm was 34.7 cpm (95% CI: 4.1, 65.3) and 4.7 min/day (95% CI: 0.6, 8.8) higher, respectively, compared to the control arm. There were no significant intervention effects on daily PA level, MVPA or time spent sedentary for adolescents in the DWBH-intervention arm. Adolescents in the PAL-intervention arm increased distance covered in the running test compared to controls (19.8 m, 95% CI: 10.4, 29.1), whilst a negative intervention effect was observed among adolescents in the DWBH-intervention arm (- 11.6 m, 95% CI: - 22.0, - 1.1).
CONCLUSION
The PAL-intervention resulted in a significantly smaller decrease in daily PA level, time spent in MVPA, and increased CRF compared to controls. Our results indicate that a teacher-led intervention, including three unique intervention components, is effective in curbing the decline in PA observed across our cohort and improving CRF.
TRIAL REGISTRATION
ClinicalTrials.gov ID nr: NCT03817047 . Registered 01/25/2019 'retrospectively registered'.",2020,"There were no significant intervention effects on daily PA level, MVPA or time spent sedentary for adolescents in the DWBH-intervention arm.","['adolescents', '30 Norwegian secondary schools (N\u2009=\u20092084, mean age [SD]\u2009=\u200914 [0.3] years) to one of three study arms']","['school-based PA interventions', 'physically active learning (PAL) intervention included 30\u2009min physically active learning, 30\u2009min PA and a 60\u2009min physical education (PE) lesson per week', 'school-based intervention']","['vigorous-intensity PA (MVPA', 'physical activity, cardiorespiratory fitness and muscle strength', 'daily PA level, time spent in MVPA, and increased CRF', 'negative intervention effect', 'daily PA levels, cardiorespiratory fitness (CRF) and muscle strength', 'PA level and MVPA', 'daily PA level, MVPA or time spent sedentary for adolescents', 'distance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",30.0,0.0899948,"There were no significant intervention effects on daily PA level, MVPA or time spent sedentary for adolescents in the DWBH-intervention arm.","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Kolle', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Ullevål Stadion, PB 4014, 0806, Oslo, Norway. elink@nih.no.'}, {'ForeName': 'Runar Barstad', 'Initials': 'RB', 'LastName': 'Solberg', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Ullevål Stadion, PB 4014, 0806, Oslo, Norway.'}, {'ForeName': 'Reidar', 'Initials': 'R', 'LastName': 'Säfvenbom', 'Affiliation': 'Department of Physical Education, Norwegian School of Sport Sciences, Ullevål Stadion, PB 4014, 0806, Oslo, Norway.'}, {'ForeName': 'Sindre M', 'Initials': 'SM', 'LastName': 'Dyrstad', 'Affiliation': 'Faculty of Health Science, Department of Public Health, University of Stavanger, Forus, PB 8600, 4036, Stavanger, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Faculty of Health and Sport Science, Department of Sport Science and Physical Education, University of Agder, PB 422, 4604, Kristiansand, Norway.'}, {'ForeName': 'Geir K', 'Initials': 'GK', 'LastName': 'Resaland', 'Affiliation': 'Center for Physically Active Learning, Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Campus Sogndal, 6856, Bergen, Norway.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Ekelund', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Ullevål Stadion, PB 4014, 0806, Oslo, Norway.'}, {'ForeName': 'Sigmund A', 'Initials': 'SA', 'LastName': 'Anderssen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Ullevål Stadion, PB 4014, 0806, Oslo, Norway.'}, {'ForeName': 'Jostein', 'Initials': 'J', 'LastName': 'Steene-Johannessen', 'Affiliation': 'Department of Sports Medicine, Norwegian School of Sport Sciences, Ullevål Stadion, PB 4014, 0806, Oslo, Norway.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Grydeland', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Ullevål Stadion, PB 4014, 0806, Oslo, Norway.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01060-0']
2834,33243286,BRAINSTORMING: A study protocol for a randomised double-blind clinical trial to assess the impact of concurrent brain stimulation (tDCS) and working memory training on cognitive performance in Acquired Brain Injury (ABI).,"BACKGROUND
Acquired Brain Injury (ABI) admissions have an incidence of 385 per 100,000 of the population in the UK, and as brain injury often involves the frontal networks, cognitive domains affected are likely to be executive control, working memory, and problem-solving deficits, resulting in difficulty with everyday activities. The above observations make working memory, and related constructs such as attention and executive functioning attractive targets for neurorehabilitation. We propose a combined home-based rehabilitation protocol involving the concurrent administration of a working memory training program (adaptive N-back task) with non-invasive transcranial direct current stimulation (tDCS) of the right dorsolateral prefrontal cortex to promote long-lasting modification of brain areas underlying working memory function.
METHOD
Patients with a working memory deficit will be recruited and assigned to two age-matched groups receiving working memory training for 2 weeks: an active group, receiving tDCS (2 mA for 20 min), and a control group, receiving sham stimulation. After the end of the first 2 weeks, both groups will continue the working memory training for three more weeks. Outcome measures will be recorded at timepoints throughout the intervention, including baseline, after the 2 weeks of stimulation, at the end of the working memory training regimen and 1 month after the completion of the training.
DISCUSSION
The aim of the study is to assess if non-invasive tDCS stimulation has an impact on performance and benefits of a working memory training regimen. Specifically, we will examine the impact of brain stimulation on training gains, if changes in gains would last, and whether changes in training performance transfer to other cognitive domains. Furthermore, we will explore whether training improvements impact on everyday life activities and how the home-based training regimen is received by participants, with the view to develop an effective home healthcare tool that could enhance working memory and daily functioning.
TRIAL REGISTRATION
This study was registered with clinicaltrials.gov: NCT04010149 on July 8, 2019.",2020,"We propose a combined home-based rehabilitation protocol involving the concurrent administration of a working memory training program (adaptive N-back task) with non-invasive transcranial direct current stimulation (tDCS) of the right dorsolateral prefrontal cortex to promote long-lasting modification of brain areas underlying working memory function.
","['Acquired Brain Injury (ABI', 'Patients with a working memory deficit will be recruited and assigned to two age-matched groups receiving']","['working memory training program (adaptive N-back task) with non-invasive transcranial direct current stimulation (tDCS', 'concurrent brain stimulation (tDCS) and working memory training', 'working memory training for 2 weeks: an active group, receiving tDCS (2\u2009mA for 20\u2009min), and a control group, receiving sham stimulation']",['cognitive performance'],"[{'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.125171,"We propose a combined home-based rehabilitation protocol involving the concurrent administration of a working memory training program (adaptive N-back task) with non-invasive transcranial direct current stimulation (tDCS) of the right dorsolateral prefrontal cortex to promote long-lasting modification of brain areas underlying working memory function.
","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Assecondi', 'Affiliation': 'Visual Experience Laboratory, School of Psychology, University of Birmingham, Birmingham, UK. s.assecondi@bham.ac.uk.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': ""Department of Neurology, Guangzhou First People's Hospital, School of Medicine, South China University of Technology, Guangzhou, Guangdong, China.""}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Eskes', 'Affiliation': 'Departments of Psychiatry and Psychology & Neuroscience, Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Read', 'Affiliation': 'Northamptonshire Healthcare NHS Foundation Trust, Northampton, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Griffiths', 'Affiliation': 'Northamptonshire Healthcare NHS Foundation Trust, Northampton, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Shapiro', 'Affiliation': 'Visual Experience Laboratory, School of Psychology, University of Birmingham, Birmingham, UK.'}]",BMC psychology,['10.1186/s40359-020-00454-w']
2835,33244404,"Social support, adherence to Mediterranean diet and physical activity in adults: results from a community-based cross-sectional study.","There is a growing recognition that social support can potentially exert consistent or opposing effects in influencing health behaviours. The present paper presents a cross-sectional study, including 2,064 adults from Italy, Spain and Greece, who were participants in a multi-centre randomised controlled trial (C4H study), aiming to examine whether social support is correlated with adherence to a healthy Mediterranean diet and physical activity. Social support data were available for 1,572 participants. The majority of the sample reported emotional support availability (84·5 %), financial support availability (72·6 %) and having one or more close friends (78·2 %). Mediterranean diet adherence was significantly associated with emotional support ( P = 0·009) and social network support ( P = 0·021). No statistically significant associations were found between participant physical activity and the social support aspects studied. In conclusion, emotional and social network support may be associated with increased adherence to the Mediterranean diet. However, further research is needed to evaluate the role of social support in adherence to healthy Mediterranean diet.",2020,Mediterranean diet adherence was significantly associated with emotional support ( P = 0·009) and social network support ( P = 0·021).,"['adults', '1,572 participants', '2,064 adults from Italy, Spain and Greece, who were participants in a multi-centre randomised controlled trial (C4H study']",[],['Mediterranean diet adherence'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",2064.0,0.0215859,Mediterranean diet adherence was significantly associated with emotional support ( P = 0·009) and social network support ( P = 0·021).,"[{'ForeName': 'Elpiniki', 'Initials': 'E', 'LastName': 'Laiou', 'Affiliation': 'Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.'}, {'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Rapti', 'Affiliation': 'Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Markozannes', 'Affiliation': 'Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.'}, {'ForeName': 'Luisella', 'Initials': 'L', 'LastName': 'Cianferotti', 'Affiliation': 'Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Fleig', 'Affiliation': 'Department of Health Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Warner', 'Affiliation': 'Department of Health Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Ribas', 'Affiliation': 'Nutrition Research Foundation, Barcelona Science Park, Barcelona, Spain.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Ngo', 'Affiliation': 'Nutrition Research Foundation, Barcelona Science Park, Barcelona, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Salvatore', 'Affiliation': 'ISBEM, University of Salento, Lecce, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Trichopoulou', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Vigilanza', 'Affiliation': 'ISBEM, University of Salento, Lecce, Italy.'}, {'ForeName': 'Stavroula', 'Initials': 'S', 'LastName': 'Tsiara', 'Affiliation': 'Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Martimianaki', 'Affiliation': 'Hellenic Health Foundation, Athens, Greece.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pampaloni', 'Affiliation': 'Fondazione F.I.R.M.O., Florence, Italy.'}, {'ForeName': 'Luis Serra', 'Initials': 'LS', 'LastName': 'Majem', 'Affiliation': 'Nutrition Research Foundation, Barcelona Science Park, Barcelona, Spain.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Schwarzer', 'Affiliation': 'Department of Health Psychology, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Brandi', 'Affiliation': 'Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.'}, {'ForeName': 'Evangelia E', 'Initials': 'EE', 'LastName': 'Ntzani', 'Affiliation': 'Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.'}]",Journal of nutritional science,['10.1017/jns.2020.46']
2836,33246064,Transcranial Magnetic Stimulation and H 1 -Magnetic Resonance Spectroscopy Measures of Excitation and Inhibition Following Lorazepam Administration.,"This study aimed at better understanding the neurochemistry underlying transcranial magnetic stimulation (TMS) and magnetic resonance spectroscopy (MRS) measurements as it pertains to GABAergic activity following administration of allosteric GABA A receptor agonist lorazepam. Seventeen healthy adults (8 females, 26.0 ± 5.4 years old) participated in a double-blind, crossover, placebo-controlled study, where participants underwent TMS and MRS two hours after drug intake (placebo or lorazepam; 2.5 mg). Neuronavigated TMS measures reflecting cortical inhibition and excitation were obtained in the left primary motor cortex. Sensorimotor cortex and occipital cortex MRS data were acquired using a 3T scanner with a MEGA-PRESS sequence, allowing water-referenced [GABA] and glutamine [Glx] (glutamate + glutamine) quantification. Lorazepam administration decreased occipital [GABA], decreased motor cortex excitability and increased GABA A -receptor mediated motor cortex inhibition (short intracortical inhibition (SICI)). Lorazepam intake did not modulate sensorimotor [GABA] and TMS measures of intra-cortical facilitation, long-interval cortical inhibition, cortical silent period, and resting motor threshold. Furthermore, higher sensorimotor [GABA] was associated with higher cortical inhibition (SICI) following lorazepam administration, suggesting that baseline sensorimotor [GABA] may be valuable in predicting pharmacological or neuromodulatory treatment response. Finally, the differential effects of lorazepam on MRS and TMS measures, with respect to GABA, support the idea that TMS measures of cortical inhibition reflect synaptic GABAergic phasic inhibitory activity while MRS reflects extrasynaptic GABA.",2020,"Lorazepam administration decreased occipital [GABA], decreased motor cortex excitability and increased GABA A -receptor mediated motor cortex inhibition (SICI).","['Seventeen healthy adults (8 females, 26.0 ± 5.4 years old']","['Lorazepam', 'placebo', 'TMS', 'lorazepam', 'TMS and MRS two hours after drug intake (placebo or lorazepam', 'Neuronavigated TMS']","['occipital [GABA', 'sensorimotor [GABA] and TMS measures of intra-cortical facilitation, long-interval cortical inhibition, cortical silent period, and resting motor threshold', 'motor cortex excitability and increased GABA A -receptor mediated motor cortex inhibition (SICI']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0034807', 'cui_str': 'GABA-benzodiazepine receptor'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}]",17.0,0.180561,"Lorazepam administration decreased occipital [GABA], decreased motor cortex excitability and increased GABA A -receptor mediated motor cortex inhibition (SICI).","[{'ForeName': 'Marie Chantal', 'Initials': 'MC', 'LastName': 'Ferland', 'Affiliation': 'Département de psychologie, Université de Montréal, Québec, Canada.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Therrien-Blanchet', 'Affiliation': 'Département de psychologie, Université de Montréal, Québec, Canada.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Proulx', 'Affiliation': 'Mcgill University, Montréal, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Klees-Themens', 'Affiliation': 'Département de psychologie, Université de Montréal, Québec, Canada.'}, {'ForeName': 'Benoit-Antoine', 'Initials': 'BA', 'LastName': 'Bacon', 'Affiliation': 'Department of Psychology, Carleton University, Ottawa, Canada.'}, {'ForeName': 'Thien Thanh Dang', 'Initials': 'TTD', 'LastName': 'Vu', 'Affiliation': 'Center for Studies in Behavioral Neurobiology and Perform Center, Department of Health, Kinesiology and Applied Physiology, Concordia University, Montreal, QC, Canada; Research Center, Institut Universitaire de Gériatrie de Montréal, Montréal, Qc, Canada.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Théoret', 'Affiliation': ""Département de psychologie, Université de Montréal, Québec, Canada; Centre de recherche du Centre Hospitalier Universitaire de l'Hôpital Sainte-Justine, Montréal, Québec, Canada. Electronic address: hugo.theoret@umontreal.ca.""}]",Neuroscience,['10.1016/j.neuroscience.2020.11.011']
2837,33246500,"Effect of barberry (Berberis vulgaris) consumption on blood pressure, plasma lipids, and inflammation in patients with hypertension and other cardiovascular risk factors: study protocol for a randomized clinical trial.","BACKGROUND
Cardiovascular diseases (CVDs) remain the leading causes of morbidity and mortality in the world. Hypertension is an important and prevalent cardiovascular risk factor. The present study will be conducted to investigate the effect of barberry as a cardio-protective fruit on the blood pressure in patients with hypertension and other CVD risk factors. Furthermore, plasma concentrations of lipids and inflammatory biomarkers will be evaluated.
METHODS/DESIGN
This is an 8-week, prospective, single-blinded, parallel assigned, randomized controlled clinical trial (RCT) in which eligible men and women with hypertension and other cardiovascular risk factors will be randomized to either placebo powder (PP; containing 9 g maltodextrin, 1 g citric acid, 1 g milled sucrose and edible red color (n = 37)) or barberry powder (BP; containing 10 g milled dried barberry and 1 g of milled sucrose (n = 37)) groups. At baseline and after 8 weeks of intervention, plasma lipids and inflammatory markers, 24-h urinary nitrite/nitrate and sodium excretion, and 24-h ambulatory blood pressure monitoring (ABPM) will be measured. Anthropometric measures and dietary assessment will be performed as well. Data analysis will be done using SPSS version-21 software.
DISCUSSION
The interest in natural and functional food products has increased globally. This RCT will add to the growing literature for the potential antihypertensive, lipid-lowering, and anti-inflammatory effects of barberry in humans.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT number) NCT04084847 . Registered on 10 December 2019.",2020,"At baseline and after 8 weeks of intervention, plasma lipids and inflammatory markers, 24-h urinary nitrite/nitrate and sodium excretion, and 24-h ambulatory blood pressure monitoring (ABPM) will be measured.","['eligible men and women with hypertension and other cardiovascular risk factors', 'patients with hypertension and other CVD risk factors', 'patients with hypertension and other cardiovascular risk factors']","['placebo powder (PP; containing 9\u2009g maltodextrin, 1\u2009g citric acid, 1\u2009g milled sucrose and edible red color (n\u2009=\u200937)) or barberry powder (BP; containing 10\u2009g milled dried barberry and 1\u2009g of milled sucrose', 'barberry (Berberis vulgaris) consumption']","['plasma lipids and inflammatory markers, 24-h urinary nitrite/nitrate and sodium excretion, and 24-h ambulatory blood pressure monitoring (ABPM', 'blood pressure', 'blood pressure, plasma lipids, and inflammation', 'plasma concentrations of lipids and inflammatory biomarkers']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0873066', 'cui_str': 'Barberry Extract'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",,0.268064,"At baseline and after 8 weeks of intervention, plasma lipids and inflammatory markers, 24-h urinary nitrite/nitrate and sodium excretion, and 24-h ambulatory blood pressure monitoring (ABPM) will be measured.","[{'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Emamat', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, P.O. 19395-4741, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Shahid Rajaei Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Asadian', 'Affiliation': 'Department of Radiology, Shahid Rajaie Cardiovascular, Medical, and Research Center, Tehran, Iran.'}, {'ForeName': 'Hadith', 'Initials': 'H', 'LastName': 'Tangestani', 'Affiliation': 'Department of Nutrition, Persian Gulf Tropical Medicine Research Center, Bushehr University of Medical Sciences, Bushehr, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, P.O. 19395-4741, Iran. jnasrollahzadeh@gmail.com.'}]",Trials,['10.1186/s13063-020-04918-7']
2838,33246506,"Determinants of stunting among children under 2 years in urban informal settlements in Mumbai, India: evidence from a household census.","BACKGROUND
There is limited evidence on the determinants of childhood stunting across urban India or specifically in slum settlements. This study aims to assess the extent of stunting among children under 2 years of age and examine its determinants in informal settlements of Mumbai.
METHODS
Data were collected in 2014-2015 in a post intervention census of a cluster randomized controlled trial to improve the health of women and children. Census covered 40 slum settlements of around 600 households each. A total of 3578 children were included in the study. Mixed effects logistic regression models were used to identify factors associated with stunting.
RESULTS
The prevalence of stunting among children aged 0-23 months was 38%. In the adjusted model, higher maternal education (AOR 0.59; 95% CI 0.42, 0.82), birth interval of at least 2 years (AOR 0.71; 95% CI 0.58, 0.87) and intended conception of the child (AOR 0.80; 95% CI 0.64, 0.99) were associated with lower odds of stunting. Maternal exposure to physical violence (AOR 1.83; 95% CI 1.21, 2.77) was associated with higher odds of being stunted. A child aged 18-23 months had 5.04 times greater odds (95% CI 3.91, 6.5) of being stunted than a child less than 6 months of age. Male child had higher odds of being stunted (AOR 1.33; 95% CI 1.14, 1.54).
CONCLUSIONS
Our findings support a multidimensional aetiology for stunting. The results of the study emphasize the importance of women's status and decision-making power in urban India, along with access to and uptake of family planning and services to provide support for survivors of domestic violence. Ultimately, a multilateral effort is needed to ensure the success of nutrition-specific interventions by focusing on the underlying health and social status of women living in urban slums.
TRIAL REGISTRATION
ISRCTN Register: ISRCTN56183183 , and Clinical Trials Registry of India: CTRI/2012/09/003004.",2020,"Male child had higher odds of being stunted (AOR 1.33; 95% CI 1.14, 1.54).
","['Data were collected in 2014-2015 in a post intervention census of a cluster randomized controlled trial to improve the health of women and children', 'women living in urban slums', '3578 children were included in the study', 'children under 2\u2009years of age and examine its determinants in informal settlements of Mumbai']",[],"['birth interval', 'maternal education', 'prevalence of stunting', 'Maternal exposure to physical violence']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007663', 'cui_str': 'Census'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]",[],"[{'cui': 'C0005605', 'cui_str': 'Birth Spacing'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0243033', 'cui_str': 'Maternal Exposure'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]",3578.0,0.217791,"Male child had higher odds of being stunted (AOR 1.33; 95% CI 1.14, 1.54).
","[{'ForeName': 'Sushmita', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Society for Nutrition, Education and Health Action, Behind Bldg. No. 11, BMC Colony, Shastri Nagar, Santa Cruz (W), Mumbai, 400 054, India. sushmita@snehamumbai.org.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Chanani', 'Affiliation': 'Society for Nutrition, Education and Health Action, Behind Bldg. No. 11, BMC Colony, Shastri Nagar, Santa Cruz (W), Mumbai, 400 054, India.'}, {'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Shah More', 'Affiliation': 'Society for Nutrition, Education and Health Action, Behind Bldg. No. 11, BMC Colony, Shastri Nagar, Santa Cruz (W), Mumbai, 400 054, India.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osrin', 'Affiliation': 'UCL Institute for Global Health, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'Shanti', 'Initials': 'S', 'LastName': 'Pantvaidya', 'Affiliation': 'Society for Nutrition, Education and Health Action, Behind Bldg. No. 11, BMC Colony, Shastri Nagar, Santa Cruz (W), Mumbai, 400 054, India.'}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Jayaraman', 'Affiliation': 'Society for Nutrition, Education and Health Action, Behind Bldg. No. 11, BMC Colony, Shastri Nagar, Santa Cruz (W), Mumbai, 400 054, India.'}]","Journal of health, population, and nutrition",['10.1186/s41043-020-00222-x']
2839,33246599,"Response to Letter to the Editor: Efficacy and Safety of Sintilimab Plus Pemetrexed and Platinum as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC: A Randomized, Double-Blind, Phase 3 Study (ORIENT-11).",,2020,,['Locally Advanced or Metastatic Nonsquamous NSCLC'],['Sintilimab Plus Pemetrexed and Platinum'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C4760864', 'cui_str': 'sintilimab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]",[],,0.314342,,"[{'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': ""Medical Science and Strategy Oncology, Innovent Biologics, Inc., Shanghai, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Medical Oncology Department, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China. Electronic address: zhangli@sysucc.org.cn.""}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.09.028']
2840,33247553,Incentives conditioned on tenofovir levels to support PrEP adherence among young South African women: a randomized trial.,"INTRODUCTION
HIV incidence remains high among African adolescent girls and young women (AGYW), who would benefit from pre-exposure prophylaxis (PrEP). Strategies to increase PrEP adherence and persistence need to be evaluated in African AGY, including incentives conditional on high adherence.
METHODS
The 3Ps for Prevention Study was a 12-month prospective cohort of 200 women ages 16 to 25 initiating PrEP in South Africa from 2017 to 2018. Participants received retrospective feedback about drug levels at Months 1, 2 and 3; half was randomized to receive a 200 Rand shopping voucher ($13 US) at Months 2, 3 and 4, conditioned on high intracellular tenofovir diphosphate (TFV-DP) levels in dried blood spots (≥500 fmol/punch at Month 1, ≥700 fmol/punch at Months 2 and 3). The primary analysis was intention-to-treat, comparing the proportion with high PrEP adherence (≥700 fmol/punch) at Month 3 by randomized group, based on 100% efficacy among men who have sex with men.
RESULTS
Median age of the 200 women was 19 years (interquartile range [IQR] 17, 21); 86% had a primary sexual partner. At Month 3, the mean TFV-DP level was 822 fmol/punch (SD 522) in the incentive group and 689 fmol/punch (SD 546) in the control group (p = 0.11). Forty-five (56%) of 85 women in the incentive group and 35 (41%) of 85 women in the control group had TFV-DP levels ≥700 fmol/punch (RR 1.35; 95% CI 0.98, 1.86; p = 0.067), which declined to 8% and 5% in the incentive and control groups at Month 12 (no significant difference by arm). 44% refilled PrEP without gaps, 14% had a gap of ≥3 weeks in coverage subsequently restarted PrEP and 54% accepted at the final dispensing visit at Month 9. No new HIV infections were observed after PrEP initiation.
CONCLUSIONS
Among South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non-statistically significant higher proportion with high adherence among those in the incentive group. Over half persisted with the 12-month PrEP programme although high adherence declined after Month 3. Strategies to support PrEP adherence and persistence and longer-acting PrEP formulations are needed.",2020,"Among South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non-statistically significant higher proportion with high adherence among those in the incentive group.","['Median age of the 200 women was 19\xa0years (interquartile range [IQR] 17, 21); 86% had a primary sexual partner', '200 women ages 16 to 25 initiating PrEP in South Africa from 2017 to 2018', 'African adolescent girls and young women (AGYW), who would benefit from pre-exposure prophylaxis (PrEP', 'young South African women', 'men who have sex with men']","['tenofovir levels', '200 Rand shopping voucher ($13 US) at Months 2, 3 and 4, conditioned on high intracellular tenofovir diphosphate (TFV-DP) levels in dried blood spots']","['mean TFV-DP level', 'TFV-DP levels', 'PrEP adherence', 'new HIV infections']","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0386744', 'cui_str': 'AM 19'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3712637', 'cui_str': 'tenofovir diphosphate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}]",200.0,0.0806571,"Among South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non-statistically significant higher proportion with high adherence among those in the incentive group.","[{'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Morton', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Stein', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Myers', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Chan School of Public Health, Harvard University, Boston, MA, USA.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, Berkeley, CA, USA.""}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Duyver', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Eve', 'Initials': 'E', 'LastName': 'Mendel', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Keshani', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Dallimore', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Lubbe', 'Initials': 'L', 'LastName': 'Wiesner', 'Affiliation': 'Department of Pharmacology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25636']
2841,33248361,A few more steps lead to improvements in endothelial function in severe and very severe COPD.,"INTRODUCTION
Cardiovascular disease is among the most prevalent concomitant chronic diseases in COPD. Physical activity (PA) modifies endothelial function and is commonly impaired in COPD. However, studies directly investigating the effects of increased PA on endothelial function in COPD are lacking. We investigated the effect of changes in PA on endothelial function in patients with severe to very severe COPD. Furthermore, we determined which variables modify this effect.
MATERIALS AND METHODS
This is a secondary outcome analysis from a randomised controlled trial investigating the effects of combined PA counselling and pedometer-based feedback in COPD. We analysed the change in PA based on three visits during one year. We measured PA using a validated triaxial accelerometer, and endothelial function using flow-mediated dilation.
RESULTS
Data was analysed from 54 patients, which provided 101 change scores. Multiple regression modelling, including adjustment for baseline step count, showed strong evidence for an association between changes in flow-mediated dilation and changes in PA (p < 0.001). The analysis of several effect modificators showed no evidence of any influence on the interaction between PA and endothelial function: smoking status (p = 0.766), severity of airflow obstruction (p = 0.838), exacerbation frequency (p = 0.227), lung diffusion capacity of carbon monoxide % pred. (p = 0.735).
CONCLUSION
We found strong evidence that increasing steps per day ameliorates the heavily impaired endothelial function in patients with severe and very severe COPD. Further studies should examine which factors influence this relationship in a positive or negative manner.",2020,"The analysis of several effect modificators showed no evidence of any influence on the interaction between PA and endothelial function: smoking status (p = 0.766), severity of airflow obstruction (p = 0.838), exacerbation frequency (p = 0.227), lung diffusion capacity of carbon monoxide % pred.","['patients with severe and very severe COPD', 'patients with severe to very severe COPD']",['combined PA counselling and pedometer-based feedback'],"['exacerbation frequency', 'Physical activity (PA) modifies endothelial function', 'severity of airflow obstruction', 'endothelial function', 'PA and endothelial function: smoking status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.0949538,"The analysis of several effect modificators showed no evidence of any influence on the interaction between PA and endothelial function: smoking status (p = 0.766), severity of airflow obstruction (p = 0.838), exacerbation frequency (p = 0.227), lung diffusion capacity of carbon monoxide % pred.","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Kohlbrenner', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Clarenbach', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sira', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Roeder', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Kohler', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Noriane A', 'Initials': 'NA', 'LastName': 'Sievi', 'Affiliation': 'Department of Pulmonology, University Hospital Zurich, Zurich, Switzerland. Electronic address: noriane.sievi@usz.ch.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106246']
2842,33251516,"Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Health-Related Quality of Life in Sepsis.","Patients who experience sepsis often have long-term effects that may impact health-related quality of life. This study aimed to investigate whether the combination of ascorbic acid, corticosteroids, and thiamine compared with placebo improves health-related quality of life in patients with septic shock.
Design
Secondary analysis of the Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis randomized controlled trial (NCT03389555).
Setting
Thirteen tertiary-care hospitals in the United States.
Patients
Patients who were enrolled in Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis, survived to 90 days post enrollment and were able to be contacted by telephone.
Interventions
Patients were randomly assigned to parenteral ascorbic acid (1,500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days or placebo.
Measurements and Main Results
One hundred seventeen patients (59%) survived to 90 days and were administered the Short Form 36 questionnaire; of these, 72 (62%) completed the Short Form 36 (38 [53%] in the intervention group, 34 [47%] in placebo). Sixty-six (92%) completed all survey questions (36 [95%] in the intervention group, 30 [88%] in placebo). There was no significant difference in overall Short Form 36 score between intervention and placebo group (median score: 39.4 [interquartile range, 31.2-45.4] vs 43.2 [37.0-46.7], respectively, p = 0.18). We found no statistically significant difference between the two groups in any of the other health-related quality of life domains used.
Conclusions
We found no difference in the health-related quality of life in patients with septic shock treated with a combination of ascorbic acid, corticosteroids, and thiamine compared to placebo.",2020,"We found no statistically significant difference between the two groups in any of the other health-related quality of life domains used.
","['Setting\n\n\nThirteen tertiary-care hospitals in the United States', 'patients with septic shock', 'Patients\n\n\nPatients who were enrolled in Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis, survived to 90 days post enrollment and were able to be contacted by telephone']","['placebo', 'ascorbic acid, corticosteroids, and thiamine', 'parenteral ascorbic acid', 'Ascorbic Acid, Corticosteroids, and Thiamine', 'hydrocortisone (50\u2009mg), and thiamine (100\u2009mg']","['Health-Related Quality of Life in Sepsis', 'health-related quality of life']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}]",,0.698376,"We found no statistically significant difference between the two groups in any of the other health-related quality of life domains used.
","[{'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Mathias J', 'Initials': 'MJ', 'LastName': 'Holmberg', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Konacki', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Berg', 'Affiliation': 'Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Cocchi', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Center for Resuscitation Science, Department of Emergency Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}]",Critical care explorations,['10.1097/CCE.0000000000000270']
2843,33251515,Disuse-Induced Muscle Loss and Rehabilitation: The National Aeronautics and Space Administration Bed Rest Study.,"Objectives
The time course and magnitude of atrophic remodeling and the effects of an acute rehabilitation program on muscle atrophy are unclear. We sought to characterize bed rest-induced leg muscle atrophy and evaluate the safety and efficacy of an acute rehabilitation program.
Design
Prespecified analysis of a randomized controlled trial.
Setting
Single-center urban hospital.
Patients
Adults (24-55 yr) randomized to 70 days of sedentary bed rest.
Interventions
The 11-day post-bed rest rehabilitation program consisted of low intensity exercise and progressed to increased aerobic exercise duration, plyometric exercises, and higher intensity resistance exercise.
Measurements and Main Results
Upper (rectus femoris, vastus lateralis, quadriceps, hamstrings, adductors) and lower leg (medial gastrocnemius, lateral gastrocnemius, and soleus) MRI scans were obtained once before, nine times during, and three times after bed rest to assess muscle cross-sectional area. The magnitude and rate of muscle atrophy and recovery were determined for each muscle. Nine participants completed 70 days of sedentary bed rest and an 11-day rehabilitation program. A total of 11,588 muscle cross-sectional area images were quantified. Across all muscles except the rectus femoris (no change), there was a linear decline during bed rest, with the highest atrophic rate occurring in the soleus (-0.33%/d). Following rehabilitation, there was rapid recovery in all muscles; however, the quadriceps (-3.74 cm 2 ; 95% CI, -7.36 to -0.12; p = 0.04), hamstrings (-2.30 cm 2 ; 95% CI, -4.07 to -0.54; p = 0.01), medial gastrocnemius (-0.62 cm 2 ; 95% CI, -1.10 to -0.14; p = 0.01), and soleus (-1.85 cm 2 ; 95% CI, -2.90 to -0.81; p < 0.01) remained significantly lower than baseline.
Conclusions
Bed rest results in upper and lower leg muscle atrophy in a linear pattern, and an 11-day rehabilitation program was safe and effective in initiating a rapid trajectory of muscle recovery. These findings provide important information regarding the design and refinement of rehabilitation programs following bed rest.",2020,"Across all muscles except the rectus femoris (no change), there was a linear decline during bed rest, with the highest atrophic rate occurring in the soleus (-0.33%/d).","['Nine participants completed 70 days of sedentary bed rest and an 11-day rehabilitation program', 'Patients\n\n\nAdults (24-55 yr) randomized to 70 days of sedentary bed rest']","['Disuse-Induced Muscle Loss and Rehabilitation', 'acute rehabilitation program', 'low intensity exercise and progressed to increased aerobic exercise duration, plyometric exercises, and higher intensity resistance exercise']","['medial gastrocnemius', 'MRI scans', 'safety and efficacy', 'Measurements and Main Results\n\n\nUpper (rectus femoris, vastus lateralis, quadriceps, hamstrings, adductors) and lower leg (medial gastrocnemius, lateral gastrocnemius, and soleus', 'magnitude and rate of muscle atrophy and recovery']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0230446', 'cui_str': 'Both lower legs'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}]",11588.0,0.0864256,"Across all muscles except the rectus femoris (no change), there was a linear decline during bed rest, with the highest atrophic rate occurring in the soleus (-0.33%/d).","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Scott', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Downs', 'Affiliation': 'Human Physiology, Performance, Protection and Operations, National Aeronautics and Space Administration (NASA), Houston, TX.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Buxton', 'Affiliation': 'Human Physiology, Performance, Protection and Operations, University of Houston, Houston, TX.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goetchius', 'Affiliation': 'Human Physiology, Performance, Protection and Operations, University of Houston, Houston, TX.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Crowell', 'Affiliation': 'Human Physiology, Performance, Protection and Operations, MEI Technologies, Houston, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ploutz-Snyder', 'Affiliation': 'Department of Systems, Populations and Leadership, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Hackney', 'Affiliation': 'Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, Fargo, ND.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Ryder', 'Affiliation': 'Human Physiology, Performance, Protection and Operations, KBR, Houston, TX.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'English', 'Affiliation': 'Department of Clinical, Health and Applied Sciences, University of Houston-Clear Lake, Houston, TX.'}, {'ForeName': 'Lori L', 'Initials': 'LL', 'LastName': 'Ploutz-Snyder', 'Affiliation': 'Department of Systems, Populations and Leadership, University of Michigan, Ann Arbor, MI.'}]",Critical care explorations,['10.1097/CCE.0000000000000269']
2844,33251500,Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19.,"Background
Hydroxychloroquine (HC) ± azithromycin (AZ) is widely used for Covid-19. The Qatar Prospective RCT of Expediting Coronavirus Tapering (Q-PROTECT) aimed to assess virologic cure rates of HC±AZ in cases of low-acuity Covid-19.
Methods
Q-PROTECT employed a prospective, placebo-controlled design with blinded randomization to three parallel arms: placebo, oral HC (600 mg daily for one week), or oral HC plus oral AZ (500 mg day one, 250 mg daily on days two through five). At enrollment, non-hospitalized participants had mild or no symptoms and were within a day of Covid-19 positivity by polymerase chain reaction (PCR). After six days, intent-to-treat (ITT) analysis of the primary endpoint of virologic cure was assessed using binomial exact 95% confidence intervals (CIs) and χ 2 testing. (ClinicalTrials.gov NCT04349592, trial status closed to new participants.).
Findings
The study enrolled 456 participants (152 in each of three groups: HC+AZ, HC, placebo) between 13 April and 1 August 2020. HC+AZ, HC, and placebo groups had 6 (3·9%), 7 (4·6%), and 9 (5·9%) participants go off study medications before completing the medication course ( p = 0·716). Day six PCR results were available for all 152 HC+AZ participants, 149/152 (98·0%) HC participants, and 147/152 (96·7%) placebo participants. Day six ITT analysis found no difference ( p = 0·821) in groups' proportions achieving virologic cure: HC+AZ 16/152 (10·5%), HC 19/149 (12·8%), placebo 18/147 (12·2%). Day 14 assessment also showed no association ( p = 0·072) between study group and viral cure: HC+AZ 30/149 (20·1%,), HC 42/146 (28·8%), placebo 45/143 (31·5%). There were no serious adverse events.
Interpretation
HC±AZ does not facilitate virologic cure in patients with mild or asymptomatic Covid-19.
Funding
The study was supported by internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar).",2020,Day six ITT analysis found no difference ( p = 0·821) in groups' proportions achieving virologic cure:,"['patients with mild or asymptomatic Covid-19', 'internal institutional funds of the Hamad Medical Corporation (government health service of the State of Qatar', 'between 13 April and 1 August 2020', 'cases of low-acuity Covid-19', '456 participants (152 in each of three groups']","['hydroxychloroquine with or without azithromycin', 'oral HC plus oral AZ', 'HC±AZ', 'HC+AZ', 'placebo', '\n\n\nHydroxychloroquine (HC) ± azithromycin (AZ', 'placebo, oral HC', 'HC+AZ, HC, and placebo', 'HC+AZ, HC, placebo']","['virologic cure', 'virologic cure rates', 'virologic cure of non-severe Covid-19']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0034366', 'cui_str': 'Qatar'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",456.0,0.523602,Day six ITT analysis found no difference ( p = 0·821) in groups' proportions achieving virologic cure:,"[{'ForeName': 'Ali S', 'Initials': 'AS', 'LastName': 'Omrani', 'Affiliation': 'Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.'}, {'ForeName': 'Sameer A', 'Initials': 'SA', 'LastName': 'Pathan', 'Affiliation': 'Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Thomas', 'Affiliation': 'BSc Candidate in Medical Biosciences, Faculty of Medicine, Imperial College London, UK.'}, {'ForeName': 'Tim R E', 'Initials': 'TRE', 'LastName': 'Harris', 'Affiliation': 'Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.'}, {'ForeName': 'Peter V', 'Initials': 'PV', 'LastName': 'Coyle', 'Affiliation': 'Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Thomas', 'Affiliation': 'Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.'}, {'ForeName': 'Isma', 'Initials': 'I', 'LastName': 'Qureshi', 'Affiliation': 'Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.'}, {'ForeName': 'Zain A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.'}, {'ForeName': 'Naema Al', 'Initials': 'NA', 'LastName': 'Mawlawi', 'Affiliation': 'Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.'}, {'ForeName': 'Reham Al', 'Initials': 'RA', 'LastName': 'Kahlout', 'Affiliation': 'Departments of Virology and Laboratory Medicine and Pathology, Hamad Medical Corporation, Doha.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Elmalik', 'Affiliation': 'Department of Pharmacy, Hamad General Hospital, Doha, Qatar.'}, {'ForeName': 'Aftab M', 'Initials': 'AM', 'LastName': 'Azad', 'Affiliation': 'Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Daghfal', 'Affiliation': 'Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.'}, {'ForeName': 'Mulham', 'Initials': 'M', 'LastName': 'Mustafa', 'Affiliation': 'Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jeremijenko', 'Affiliation': 'Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.'}, {'ForeName': 'Hussam Al', 'Initials': 'HA', 'LastName': 'Soub', 'Affiliation': 'Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.'}, {'ForeName': 'Mohammed Abu', 'Initials': 'MA', 'LastName': 'Khattab', 'Affiliation': 'Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.'}, {'ForeName': 'Muna Al', 'Initials': 'MA', 'LastName': 'Maslamani', 'Affiliation': 'Department of Medicine, Hamad Medical Corporation Communicable Diseases Center, Doha, Qatar.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Thomas', 'Affiliation': 'Department of Emergency Medicine, Hamad General Hospital, Doha 3050, Qatar.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100645']
2845,33251324,Effects of a simple cardiac rehabilitation program on improvement of self-reported physical activity in atrial fibrillation - Data from the RACE 3 study.,"Background and aim
Physical inactivity is associated with an increased prevalence of atrial fibrillation (AF). We aim to evaluate whether cardiac rehabilitation (CR) motivates patients to become and stay physical active, and whether CR affects sinus rhythm maintenance and quality of life (QoL) in patients with persistent AF and moderate heart failure.
Methods
In the Routine versus Aggressive risk factor driven upstream rhythm Control for prevention of Early atrial fibrillation in heart failure study patients were randomized to conventional or targeted therapy. Targeted therapy contained next to optimal risk factor management a 3-month CR program, including self-reported physical activity and counseling. Successful physical activity was assessed in the targeted group, defined as activity of moderate intensity ≥ 150 min/week, or ≥ 75 min/week of vigorous intensity. AF was assessed at 1 year on 7-days Holter monitoring, QoL using general health, fatigue and AF symptom questionnaires.
Results
All 119 patients within the targeted group participated in the CR program, 106 (89%) completed it. At baseline 80 (67%) patients were successfully physical active, 39 (33%) were not. NTproBNP was lower in active patients. During 1-year follow-up physical active patients stayed active: 72 (90%) at 12 weeks, 72 (90%) at 1 year. Inactive patients became active: at 12 weeks 25 (64%) patients and 30 (77%) at 1 year. No benefits were seen on sinus rhythm maintenance and QoL for successful physical active patients.
Conclusion
In patients with persistent AF and moderate heart failure participation in CR contributes to improve and to maintain physical activity.",2020,"During 1-year follow-up physical active patients stayed active: 72 (90%) at 12 weeks, 72 (90%) at 1 year.","['heart failure study patients', 'All 119 patients within the targeted group participated in the CR program, 106 (89%) completed it', 'patients with persistent AF and moderate heart failure']","['Routine versus Aggressive risk factor driven upstream rhythm Control', 'cardiac rehabilitation (CR', 'simple cardiac rehabilitation program']","['7-days Holter monitoring, QoL using general health, fatigue and AF symptom questionnaires', 'NTproBNP', 'Successful physical activity', 'sinus rhythm maintenance and QoL', 'sinus rhythm maintenance and quality of life (QoL', 'prevalence of atrial fibrillation (AF']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0522505', 'cui_str': 'Upstream'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0669479', 'cui_str': 'pro-brain natriuretic peptide (1-76)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",,0.0272149,"During 1-year follow-up physical active patients stayed active: 72 (90%) at 12 weeks, 72 (90%) at 1 year.","[{'ForeName': 'Bao Oanh', 'Initials': 'BO', 'LastName': 'Nguyen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'E P J Petra', 'Initials': 'EPJP', 'LastName': 'Wijtvliet', 'Affiliation': 'Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Hobbelt', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Simone I M', 'Initials': 'SIM', 'LastName': 'De Vries', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Marcelle D', 'Initials': 'MD', 'LastName': 'Smit', 'Affiliation': 'Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Tieleman', 'Affiliation': 'Martini Hospital, Groningen, the Netherlands.'}, {'ForeName': 'Dirk Jan', 'Initials': 'DJ', 'LastName': 'Van Veldhuisen', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Harry J G M', 'Initials': 'HJGM', 'LastName': 'Crijns', 'Affiliation': 'Maastricht University Medical Center+ and Cardiovascular Research Institute Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Van Gelder', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Rienstra', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of cardiology. Heart & vasculature,['10.1016/j.ijcha.2020.100673']
2846,33249220,Application of Midazolam Injection in Patients with Intraoperative Nerve Block Anesthesia and Sedation Assisted by Medical Image.,"This paper explores the clinical effect of midazolam as an adjuvant analgesic and tranquilizer after brachial plexus block anaesthesia with the aid of medical imaging. The paper selected 106 patients who underwent elective unilateral upper extremity surgery from January 2017 to December 2019, and randomly divided them into group A and group B, with 53 cases in each group, all underwent brachial plexus block anaesthesia, and group A was given imidazole Lon assisted sedation, group B was given fentanyl + midazolam assisted sedation. Under ultrasound-guided intermuscular sulcus brachial plexus block, observe and record the ultrasound anatomical images before injection, the distance from the lower edge of the upper, middle and lower trunk of the forearm brachial plexus to the skin; observe and record the operation time and the effect of anaesthesia block And the incidence of adverse reactions. The distance from the lower edge of each nerve trunk to the skin (average value): upper stem 1.002 cm, middle stem 1.598 cm, and lower stem 2.26 cm. The average operation time is 3min+56s; 92% of the operation time is within 3-5min. The anaesthesia effect was 81% excellent, 11% good, 6% poor, 2% ineffective, and 92% effective. Ultrasound guided inferior intermuscular sulcus approach brachial plexus block is suitable for unilateral upper extremity hand radial surgery. For surgery involving the upper extremity hand ulnar side, a larger dose (concentration) of local anaesthetics should be used within a safe range and (or) additional ulnar nerve block is necessary. Midazolam adjuvant medication can play a good sedative and amnestic effect in brachial plexus block anaesthesia, help reduce pain and inhibit the increase in stress levels.",2020,"The anaesthesia effect was 81% excellent, 11% good, 6% poor, 2% ineffective, and 92% effective.","['106 patients who underwent elective unilateral upper extremity surgery from January 2017 to December 2019', 'unilateral upper extremity hand radial surgery', 'Patients with Intraoperative Nerve Block Anesthesia and Sedation Assisted by Medical Image']","['Ultrasound guided inferior intermuscular sulcus approach brachial plexus block', 'midazolam', 'imidazole Lon assisted sedation', 'Midazolam adjuvant medication', 'fentanyl + midazolam assisted sedation', 'Midazolam Injection', 'brachial plexus block anaesthesia']","['anaesthesia effect', 'average operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0198802', 'cui_str': 'Nerve block anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0020923', 'cui_str': 'Imidazole'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C4051556', 'cui_str': 'Midazolam Injection'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0140007,"The anaesthesia effect was 81% excellent, 11% good, 6% poor, 2% ineffective, and 92% effective.","[{'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Rundong', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, The Affiliated Hospital of Qingdao University, Qingdao, China. Electronic address: yongshengxu6@sina.com.'}]",World neurosurgery,['10.1016/j.wneu.2020.11.101']
2847,33249198,"Glyburide therapy for gestational diabetes: Glycaemic control, maternal hypoglycaemia, and treatment failure.","AIMS
The recommended first-line treatment for women with gestational diabetes mellitus (GDM) in the case of failure of diet is insulin. Recent results suggest that there is a potential role for glyburide therapy and highlight the need for better knowledge of glycaemic control with glyburide. The objective of this study was to describe and quantify in women with GDM the quality of glycaemic control, including the risk of maternal hypoglycaemia and of therapy failure.
METHODS
This is a secondary analysis of the French INDAO non-inferiority trial from 2012 to 2016, in which 890 women with GDM randomized to receive glyburide or insulin treatment were compared for perinatal outcomes. Blood glucose concentrations were assessed prospectively during pregnancy. Optimal glycaemic control was defined as less than 20% of blood glucose values exceeding the targets.
RESULTS
More than 50% of the women had optimal glycaemic control with glyburide, similar to that with insulin. Around 40% of the women had at least one episode of hypoglycaemia, more than with insulin. However, those hypoglycaemic episodes were mostly moderate and the rate of severe hypoglycaemia decreased significantly during the course of the trial. Failure of glyburide treatment (switch to insulin therapy) occurred in 18% of women and had few predictors. However, when failure occurred, glycaemic control was improved after switching to insulin.
CONCLUSIONS
Glyburide is an effective treatment for reaching glycaemic goals during pregnancy in women with GDM. The risk of maternal hypoglycaemia may be minimized by clinical practice experience. These findings could be taken into account in the management of GDM.",2020,"More than 50% of the women had optimal glycaemic control with glyburide, similar to that with insulin.","['women with GDM', 'gestational diabetes', 'women with gestational diabetes mellitus (GDM', 'French INDAO non-inferiority trial from 2012 to 2016, in which 890 women with GDM randomized to receive']","['Glyburide', 'Glyburide therapy', 'glyburide or insulin treatment', 'glyburide']","['risk of maternal hypoglycaemia', 'episode of hypoglycaemia', 'rate of severe hypoglycaemia', 'blood glucose values', 'Blood glucose concentrations', 'glycaemic control']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}]","[{'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",890.0,0.0871289,"More than 50% of the women had optimal glycaemic control with glyburide, similar to that with insulin.","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Affres', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Department of Reproductive Endocrinology, Bicêtre Hospital, Le Kremlin-Bicêtre, France. Electronic address: helene.affres@aphp.fr.'}, {'ForeName': 'Marie-Victoire', 'Initials': 'MV', 'LastName': 'Senat', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Department of Gynaecology-Obstetrics, Bicêtre Hospital, Le Kremlin-Bicêtre, France; Université Paris-Saclay, UVSQ, Inserm, CESP, 94807, Villejuif, France. Electronic address: marie-victoire.senat@aphp.fr.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Letourneau', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Department of Gynaecology-Obstetrics, Antoine Beclere Hospital, Clamart, France. Electronic address: letourneau.alexandra@aphp.fr.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Deruelle', 'Affiliation': 'EA 4489, Environnement périnatal et croissance, PRES Université Lille Nord de France, 59000, Lille, France; Department of Obstetrics, Strasbourg University Hospital, University of Strasbourg, Strasbourg, France. Electronic address: philippe.deruelle@chru-strasbourg.fr.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Coustols-Valat', 'Affiliation': 'Department of Endocrinology-Obstetric, Toulouse University Hospital, Toulouse, France. Electronic address: magali.coustols@wanadoo.fr.'}, {'ForeName': 'Hanane', 'Initials': 'H', 'LastName': 'Bouchghoul', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Department of Gynaecology-Obstetrics, Bicêtre Hospital, Le Kremlin-Bicêtre, France; Université Paris-Saclay, UVSQ, Inserm, CESP, 94807, Villejuif, France. Electronic address: hanane.bouchghoul@aphp.fr.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bouyer', 'Affiliation': 'Université Paris-Saclay, UVSQ, Inserm, CESP, 94807, Villejuif, France. Electronic address: jean.bouyer@inserm.fr.'}]",Diabetes & metabolism,['10.1016/j.diabet.2020.11.002']
2848,33249081,Randomized Trial of Scrambler Therapy for Chemotherapy-Induced Peripheral Neuropathy: Crossover Analysis.,"BACKGROUND
Preliminary trials report that Scrambler Therapy, a form of electroanalgesia, may improve discomfort from chemotherapy-induced peripheral neuropathy (CIPN). The objective of this phase II, randomized controlled trial was to evaluate the efficacy of Scrambler Therapy versus Transcutaneous Electrical Nerve Stimulation (TENS) in treating CIPN.
METHODS
Fifty patients were accrued for the first half of this two-part, crossover trial consisting of a 2-week treatment period with either Scrambler or TENS, followed by an 8-week observation period, and then crossover treatment. Twenty-two patients proceeded to the crossover phase. The primary means of assessment was patient reported outcomes, including symptom severity scales and Global Impression of Change questionnaires. Symptoms were assessed daily during the treatment period and weekly during an 8-week observation period.
RESULTS
A 50% or greater reduction in primary symptom (pain or tingling) score on the last day of treatment was achieved by 6 of 10 Scrambler-treated patients (60%) and 3 of 12 TENS-treated patients (25%) following crossover (p=0.11). By day 4 of treatment, the two arms diverged with respect to mean change in primary symptom score; this effect was largely carried through to the end of the two-week treatment period. Similarly, Scrambler Therapy appeared better than TENS when assessed by Global Impression of Change for neuropathy, pain, and overall quality of life.
CONCLUSIONS
Similar findings from the initial randomization and crossover phases of this study support further evaluation of the efficacy of Scrambler Therapy in alleviating CIPN symptoms. Evaluation in a larger, randomized controlled trial with standardized treatment is warranted.",2020,"By day 4 of treatment, the two arms diverged with respect to mean change in primary symptom score; this effect was largely carried through to the end of the two-week treatment period.",['Fifty patients'],"['Scrambler or TENS', 'Scrambler Therapy', 'Scrambler Therapy versus Transcutaneous Electrical Nerve Stimulation (TENS']","['Global Impression of Change for neuropathy, pain, and overall quality of life', 'symptom severity scales and Global Impression of Change questionnaires', 'primary symptom (pain or tingling) score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",50.0,0.0845854,"By day 4 of treatment, the two arms diverged with respect to mean change in primary symptom score; this effect was largely carried through to the end of the two-week treatment period.","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Childs', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota, United States. Electronic address: childs.daniel@mayo.edu.'}, {'ForeName': 'Jennifer G', 'Initials': 'JG', 'LastName': 'Le-Rademacher', 'Affiliation': 'Department of Health Sciences Research, Section of Cancer Center Statistics, Mayo Clinic, Rochester, Minnesota, United States.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McMurray', 'Affiliation': 'Department of Health Sciences Research, Section of Cancer Center Statistics, Mayo Clinic, Rochester, Minnesota, United States.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Bendel', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': ""O'Neill"", 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, Minnesota, United States.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.11.025']
2849,33249071,A pilot study on amygdala volumetric changes among young adults with childhood maltreatment histories after a mindfulness intervention.,"The amygdala morphometry is highly sensitive to stress and is implicated in various psychopathologies that are common among individuals with childhood maltreatment histories. This pilot study investigated bilateral amygdala volumetric changes among 15 young adults with childhood maltreatment histories undergoing an eight-week mindfulness intervention compared to 19 matched participants in a waitlist control group. Results indicated significant cross-individual variability in amygdala volumetric changes after the intervention, which resulted in no significant group by time interaction effect. Degree and direction of changes in right amygdala volume correlated with baseline volumes, with larger than average right amygdala showing an increase in volume and smaller amygdala a decrease. Increasing right amygdala volume was also associated with higher intervention compliance, and a greater increase in self-compassion. Increasing left amygdala volume was associated with more reduction in perceived stress, rejection sensitivity and interpersonal distress. Findings from the present study highlight the importance of investigating individual variability and its contributing factors in future studies on neural responses of mindfulness interventions, as well as the distinct responses of the left and right amygdala.",2020,"Increasing left amygdala volume was associated with more reduction in perceived stress, rejection sensitivity and interpersonal distress.","['individuals with childhood maltreatment histories', 'young adults with childhood maltreatment histories after a mindfulness intervention', '15 young adults with childhood maltreatment histories undergoing an eight-week mindfulness intervention compared to 19 matched participants in a waitlist control group']",[],"['Degree and direction of changes in right amygdala volume', 'amygdala volumetric changes', 'perceived stress, rejection sensitivity and interpersonal distress', 'self-compassion', 'Increasing right amygdala volume']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",19.0,0.0118976,"Increasing left amygdala volume was associated with more reduction in perceived stress, rejection sensitivity and interpersonal distress.","[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Joss', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA. Electronic address: djoss@mclean.harvard.edu.'}, {'ForeName': 'Alaptagin', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Sara W', 'Initials': 'SW', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Teicher', 'Affiliation': 'Developmental Biopsychiatry Research Program, McLean Hospital, Belmont, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, USA.'}]",Behavioural brain research,['10.1016/j.bbr.2020.113023']
2850,33249056,Individually started versus randomly started mild ovarian stimulation for IVF in poor responders.,,2020,,[],[],[],[],[],[],,0.0243979,,"[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Tesarik', 'Affiliation': 'MARGen Clinic, Granada 18006, Spain. Electronic address: jtesarik@clinicamargen.com.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.11.006']
2851,33245754,"COVID-19, hypertension, and RAAS blockers: the BRACE-CORONA trial.",,2020,,[],[],[],[],[],[],,0.0230036,,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'University of Milano-Bicocca, Milan, Italy.'}]",Cardiovascular research,['10.1093/cvr/cvaa325']
2852,33245807,Promoting meaningful and positive nature interactions for visitors to green spaces.,"The increasing alienation of people from nature is profoundly concerning because people's interactions with nature affect well-being, affinity for nature, and support of biodiversity conservation. Efforts to restore or enhance people's interactions with nature are, therefore, important to ensure sustainable human and wildlife communities, but little is known about how this can be achieved. A key factor that shapes the way people interact with nature is their affinity for nature (often measured as nature relatedness [NR]). We explored how using cues to experience nature as a means to induce NR situationally can influence the quality of people's nature interactions on visits to green spaces and their positive affect after the visit. Cues to experience are cues that guide individuals on how to interact with nature. We surveyed 1023 visitors to a nature reserve to examine the relationships between trait (i.e., stable and long-lasting) and state (i.e., temporary, brief) NR, the quality of nature interactions, and positive affect. We also conducted a controlled experiment in which 303 participants spent 30 min outdoors on campus and reported the quality of their nature interactions and positive affect. Participants were randomly assigned to 1 of 9 cues-to-experience experimental groups (e.g., smell flowers, observe wildlife, turn off your phone) that differed in the psychological distance from nature that they prompted. Participants who received cues of close psychological distance from nature (e.g., smell and touch natural elements) interacted 3 to 4 times more with nature and reported 0.2 more positive affect than other participants. Our results demonstrate that providing cues to experience nature, which bring people closer to nature and potentially induce state NR, can enhance the quality of people's nature interactions and their positive affect. These results highlight the role of NR in high-quality nature interactions and suggest the use of cues to experience as a promising avenue for inducing state NR and promoting meaningful interactions with biodiversity, thus, reconciling conservation and well-being objectives.",2020,"The increasing alienation of people from nature is profoundly concerning because people's interactions with nature affect well-being, affinity for nature, and support of biodiversity conservation.",['303 participants spent 30 min outdoors on campus'],[],[],"[{'cui': 'C0456693', 'cui_str': '/30 min'}]",[],[],303.0,0.0193867,"The increasing alienation of people from nature is profoundly concerning because people's interactions with nature affect well-being, affinity for nature, and support of biodiversity conservation.","[{'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Colléony', 'Affiliation': 'Human and Biodiversity Research Lab, Faculty of Architecture and Town Planning, Technion-Israel Institute of Technology, Haifa, 32000, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Levontin', 'Affiliation': 'Faculty of Industrial Engineering and Management, Technion-Israel Institute of Technology, Haifa, 32000, Israel.'}, {'ForeName': 'Assaf', 'Initials': 'A', 'LastName': 'Shwartz', 'Affiliation': 'Human and Biodiversity Research Lab, Faculty of Architecture and Town Planning, Technion-Israel Institute of Technology, Haifa, 32000, Israel.'}]",Conservation biology : the journal of the Society for Conservation Biology,['10.1111/cobi.13624']
2853,33246481,Comparison of peri-implant submucosal microbiota in arches with zirconia or titanium implant-supported fixed complete dental prostheses: a study protocol for a randomized controlled trial.,"BACKGROUND
The success rate of implant-supported prostheses for edentulous patients is relatively high. However, the incidence of biological complications, especially peri-implant mucositis and peri-implantitis, increases yearly after the placement of prostheses. The accumulation of pathogenic bacteria adjacent to a prosthesis is the main cause of biological complications. Titanium, one of the classical materials for implant-supported prostheses, performs well in terms of biocompatibility and ease of maintenance, but is still susceptible to biofilm formation. Zirconia, which has emerged as an appealing substitute, not only has comparable properties, but presents different surface properties that influence the adherence of oral bacteria. However, evidence of a direct effect on oral flora is limited. Therefore, the aim of the present study was to assess the effects of material properties on biofilm formation and composition.
METHODS
The proposed study is designed as a 5-year randomized controlled trial. We plan to enroll 44 edentulous (mandible) patients seeking full-arch, fixed, implant-supported prostheses. The participants will be randomly allocated to one of two groups: group 1, in which the participants will receive zirconia frameworks with ceramic veneering, or group 2, in which the participants will receive titanium frameworks with acrylic resin veneering. Ten follow-up examinations will be completed by the end of this 5-year trial. Mucosal conditions around the implants will be recorded every 6 months after restoration. Peri-implant submucosal plaque will be collected at each reexamination, and bacteria flora analysis will be performed with 16S rRNA gene sequencing technology in order to compare differences in microbial diversity between groups. One week before each visit, periodontal maintenance will be arranged. Each participant will receive an X-ray examination every 12 months as a key index to evaluate the marginal bone level around the implants.
DISCUSSION
The current study aims to explore the oral microbiology of patients following dental restoration with zirconia ceramic frameworks or titanium frameworks. The features of the microbiota and the mucosal condition around the two different materials will be evaluated and compared to determine whether zirconia is an appropriate material for fixed implant-supported prostheses for edentulous patients.
TRIAL REGISTRATION
International Clinical Trials Registry Platform (ICTRP) ChiCTR2000029470. Registered on 2 February 2020. http://www.chictr.org.cn/searchproj.aspx?",2020,"Titanium, one of the classical materials for implant-supported prostheses, performs well in terms of biocompatibility and ease of maintenance, but is still susceptible to biofilm formation.","['edentulous patients', '44 edentulous (mandible) patients seeking full-arch, fixed, implant-supported prostheses', 'peri-implant submucosal microbiota in arches with zirconia or titanium implant-supported fixed complete dental prostheses', 'patients following dental restoration with zirconia ceramic frameworks or titanium frameworks']","['zirconia', 'zirconia frameworks with ceramic veneering', 'titanium frameworks with acrylic resin veneering']","['biofilm formation and composition', 'biological complications, especially peri-implant mucositis and peri-implantitis']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0399059', 'cui_str': 'Restoration of tooth'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0007742', 'cui_str': 'Ceramic'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}, {'cui': 'C0559953', 'cui_str': 'Veneer'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}]",,0.165966,"Titanium, one of the classical materials for implant-supported prostheses, performs well in terms of biocompatibility and ease of maintenance, but is still susceptible to biofilm formation.","[{'ForeName': 'Pingyi', 'Initials': 'P', 'LastName': 'Jia', 'Affiliation': ""Department of the Fourth Clinical Division, Peking University School and Hospital of Stomatology; National Engineering Laboratory for Digital and Material Technology of Stomatology; Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health; Beijing Key Laboratory of Digital Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Prosthodontics, Peking University School and Hospital of Stomatology; National Engineering Laboratory for Digital and Material Technology of Stomatology; Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health; Beijing Key Laboratory of Digital Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Zhaoguo', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology; National Engineering Laboratory for Digital and Material Technology of Stomatology; Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health; Beijing Key Laboratory of Digital Stomatology, No. 22, Zhongguancun Avenue South, Haidian District, Beijing, 100081, People's Republic of China.""}, {'ForeName': 'Jianzhang', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Prosthodontics, Peking University School and Hospital of Stomatology; National Engineering Laboratory for Digital and Material Technology of Stomatology; Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health; Beijing Key Laboratory of Digital Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': ""BYBO Dental Hospital, Qinian Street, Dongcheng District, Beijing, 100062, People's Republic of China.""}, {'ForeName': 'Zhongning', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Prosthodontics, Peking University School and Hospital of Stomatology; National Engineering Laboratory for Digital and Material Technology of Stomatology; Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health; Beijing Key Laboratory of Digital Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Prosthodontics, Peking University School and Hospital of Stomatology; National Engineering Laboratory for Digital and Material Technology of Stomatology; Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health; Beijing Key Laboratory of Digital Stomatology, Beijing, People's Republic of China.""}, {'ForeName': 'Jianxia', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': ""Department of Periodontology, Peking University School and Hospital of Stomatology; National Engineering Laboratory for Digital and Material Technology of Stomatology; Research Center of Engineering and Technology for Digital Dentistry of Ministry of Health; Beijing Key Laboratory of Digital Stomatology, No. 22, Zhongguancun Avenue South, Haidian District, Beijing, 100081, People's Republic of China. jxhou@163.com.""}]",Trials,['10.1186/s13063-020-04853-7']
2854,33246482,"Hydroxyurea Optimization through Precision Study (HOPS): study protocol for a randomized, multicenter trial in children with sickle cell anemia.","BACKGROUND
Sickle cell disease (SCD) is a severe and devastating hematological disorder that affects over 100,000 persons in the USA and millions worldwide. Hydroxyurea is the primary disease-modifying therapy for the SCD, with proven benefits to reduce both short-term and long-term complications. Despite the well-described inter-patient variability in pharmacokinetics (PK), pharmacodynamics, and optimal dose, hydroxyurea is traditionally initiated at a weight-based dose with a subsequent conservative dose escalation strategy to avoid myelosuppression. Because the dose escalation process is time consuming and requires frequent laboratory checks, many providers default to a fixed dose, resulting in inadequate hydroxyurea exposure and suboptimal benefits for many patients. Results from a single-center trial of individualized, PK-guided dosing of hydroxyurea for children with SCD suggest that individualized dosing achieves the optimal dose more rapidly and provides superior clinical and laboratory benefits than traditional dosing strategies. However, it is not clear whether these results were due to individualized dosing, the young age that hydroxyurea treatment was initiated in the study, or both. The Hydroxyurea Optimization through Precision Study (HOPS) aims to validate the feasibility and benefits of this PK-guided dosing approach in a multi-center trial.
METHODS
HOPS is a randomized, multicenter trial comparing standard vs. PK-guided dosing for children with SCD as they initiate hydroxyurea therapy. Participants (ages 6 months through 21 years), recruited from 11 pediatric sickle cell centers across the USA, are randomized to receive hydroxyurea either using a starting dose of 20 mg/kg/day (Standard Arm) or a PK-guided dose (Alternative Arm). PK data will be collected using a novel sparse microsampling approach requiring only 10 μL of blood collected at 3 time-points over 3 h. A protocol-guided strategy more aggressive protocols is then used to guide dose escalations and reductions in both arms following initiation of hydroxyurea. The primary endpoint is the mean %HbF after 6 months of hydroxyurea.
DISCUSSION
HOPS will answer important questions about the clinical feasibility, benefits, and safety of PK-guided dosing of hydroxyurea for children with SCD with potential to change the treatment paradigm from a standard weight-based approach to one that safely and effectively optimize the laboratory and clinical response.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03789591 . Registered on 28 December 2018.",2020,A protocol-guided strategy more aggressive protocols is then used to guide dose escalations and reductions in both arms following initiation of hydroxyurea.,"['children with SCD as they initiate hydroxyurea therapy', 'children with SCD', 'Participants (ages 6\u2009months through 21\u2009years), recruited from 11 pediatric sickle cell centers across the USA', 'children with sickle cell anemia']","['hydroxyurea', 'Hydroxyurea']",['mean %HbF after 6\u2009months of hydroxyurea'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0221283', 'cui_str': 'Drepanocyte'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015936', 'cui_str': 'Hemoglobin F'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]",,0.135098,A protocol-guided strategy more aggressive protocols is then used to guide dose escalations and reductions in both arms following initiation of hydroxyurea.,"[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Meier', 'Affiliation': 'Indiana Hemophilia and Thrombosis Center, Indianapolis, IN, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Creary', 'Affiliation': ""Division of Hematology/Oncology/BMT, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Heeney', 'Affiliation': ""Division of Hematology/Oncology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Abena O', 'Initials': 'AO', 'LastName': 'Appiah-Kubi', 'Affiliation': ""Pediatric Hematology, Children's Hospitals and Clinics of Minnesota, Minneapolis and St. Paul, MN, USA.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Nelson', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, MLC 7015, Cincinnati, OH, 45229, USA.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Niss', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Piccone', 'Affiliation': ""Case Western Reserve University School of Medicine, Department of Hematology and Oncology, University Hospitals Rainbow Babies and Children's, Cleveland, OH, USA.""}, {'ForeName': 'Maa-Ohui', 'Initials': 'MO', 'LastName': 'Quarmyne', 'Affiliation': ""Emory University School of Medicine & Sickle Cell Disease Program, Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Quinn', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Kay L', 'Initials': 'KL', 'LastName': 'Saving', 'Affiliation': 'University of Illinois Peioria, Peoria, IL, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Scott', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Talati', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Teresa S', 'Initials': 'TS', 'LastName': 'Latham', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation, Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Pfeiffer', 'Affiliation': ""Department of Pediatrics, Division of Pediatric Hematology, Oncology, and Stem Cell Transplantation, Cohen Children's Medical Center of New York, New Hyde Park, NY, USA.""}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Shook', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Vinks', 'Affiliation': ""Division of Clinical Pharmacology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'McGann', 'Affiliation': 'University of Cincinnati College of Medicine, Cincinnati, OH, USA. patrick.mcgann@cchmc.org.'}]",Trials,['10.1186/s13063-020-04912-z']
2855,33246489,Potentiation of cord blood cell therapy with erythropoietin for children with CP: a 2 × 2 factorial randomized placebo-controlled trial.,"BACKGROUND
Concomitant administration of allogeneic umbilical cord blood (UCB) infusion and erythropoietin (EPO) showed therapeutic efficacy in children with cerebral palsy (CP). However, no clinical studies have investigated the effects of UCB and EPO combination therapy using a 2 × 2 four-arm factorial blinded design with four arms. This randomized placebo-controlled trial aimed to identify the synergistic and individual efficacies of UCB cell and EPO for the treatment of CP.
METHODS
Children diagnosed with CP were randomly segregated into four groups: (A) UCB+EPO, (B) UCB+placebo EPO, (C) placebo UCB+EPO, and (D) placebo UCB+placebo EPO. Based on the UCB unit selection criteria of matching for ≥ 4/6 of human leukocyte antigen (HLA)-A, -B, and DRB1 and total nucleated cell (TNC) number of ≥ 3 × 10 7 /kg, allogeneic UCB was intravenously infused and 500 IU/kg human recombinant EPO was administered six times. Functional measurements, brain imaging studies, and electroencephalography were performed from baseline until 12 months post-treatment. Furthermore, adverse events were closely monitored.
RESULTS
Eighty-eight of 92 children enrolled (3.05 ± 1.22 years) completed the study. Change in gross motor performance measure (GMPM) was greater in group A than in group D at 1 month (△2.30 vs. △0.71, P = 0.025) and 12 months (△6.85 vs. △2.34, P = 0.018) post-treatment. GMPM change ratios were calculated to adjust motor function at the baseline. Group A showed a larger improvement in the GMPM change ratio at 1 month and 12 months post-treatment than group D. At 12 months post-treatment, the GMPM change ratios were in the order of groups A, B, C, and D. These results indicate synergistic effect of UCB and EPO combination better than each single therapy. In diffusion tensor imaging, the change ratio of fractional anisotropy at spinothalamic radiation was higher in group A than group D in subgroup of age ≥ 3 years. Additionally, higher TNC and more HLA-matched UCB units led to better gross motor outcomes in group A. Adverse events remained unchanged upon UCB or EPO administration.
CONCLUSIONS
These results indicate that the efficacy of allogeneic UCB cell could be potentiated by EPO for neurological recovery in children with CP without harmful effects.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT01991145 , registered 25 November 2013.",2020,Group A showed a larger improvement in the GMPM change ratio at 1 month and 12 months post-treatment than group D.,"['children with cerebral palsy (CP', 'children with CP without harmful effects', 'children with CP', 'Children diagnosed with CP', 'Eighty-eight of 92 children enrolled (3.05\u2009±\u20091.22\u2009years) completed the study']","['placebo', 'allogeneic umbilical cord blood (UCB) infusion and erythropoietin (EPO', 'allogeneic UCB was intravenously infused and 500\u2009IU/kg human recombinant EPO', 'UCB+EPO, (B', 'cord blood cell therapy with erythropoietin', 'UCB+placebo EPO, (C) placebo UCB+EPO, and (D) placebo UCB+placebo EPO', 'UCB cell and EPO']","['human leukocyte antigen (HLA)-A, -B, and DRB1 and total nucleated cell (TNC) number of ≥', 'GMPM change ratios', 'gross motor performance measure (GMPM', 'adverse events', 'Functional measurements, brain imaging studies, and electroencephalography', 'GMPM change ratio', 'change ratio of fractional anisotropy at spinothalamic radiation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439463', 'cui_str': 'IU/kg'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0019629', 'cui_str': 'Class I Histocompatibility Antigens'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]",92.0,0.238622,Group A showed a larger improvement in the GMPM change ratio at 1 month and 12 months post-treatment than group D.,"[{'ForeName': 'Kyunghoon', 'Initials': 'K', 'LastName': 'Min', 'Affiliation': 'Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Mi Ri', 'Initials': 'MR', 'LastName': 'Suh', 'Affiliation': 'Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Kye Hee', 'Initials': 'KH', 'LastName': 'Cho', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Wookyung', 'Initials': 'W', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Myung Seo', 'Initials': 'MS', 'LastName': 'Kang', 'Affiliation': 'Department of Laboratory Medicine, CHA Bundang Medical Center, CHA University School of Medicine and CHA Cord Blood Bank, Seongnam, Republic of Korea.'}, {'ForeName': 'Su Jin', 'Initials': 'SJ', 'LastName': 'Jang', 'Affiliation': 'Department of Nuclear Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Sang Heum', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Seonkyeong', 'Initials': 'S', 'LastName': 'Rhie', 'Affiliation': 'Department of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Jee In', 'Initials': 'JI', 'LastName': 'Choi', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Hyun-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Rehabilitation and Regeneration Research Center, CHA University, Seongnam, Republic of Korea.'}, {'ForeName': 'Kwang Yul', 'Initials': 'KY', 'LastName': 'Cha', 'Affiliation': 'CHA Hollywood Presbyterian Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'MinYoung', 'Initials': 'M', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea. kmin@cha.ac.kr.'}]",Stem cell research & therapy,['10.1186/s13287-020-02020-y']
2856,33246638,The Role of Theranostics in Prostate Cancer.,"Theranostics in men with metastatic castration-resistant prostate cancer (mCRPC) has been developed to target bone and the tumor itself. Currently, bone-directed targeted alpha therapy with radium-223 ( 223 Ra) is the only theranostic agent proven to prolong survival in men with mCRPC who have symptomatic bone metastases and no known visceral metastases. The clinical utility and therapeutic success of 223 Ra has encouraged the development of other tumor-targeting theranostic agents in mCRPC, primarily targeting prostate-specific membrane antigen (PSMA) with radioligand therapy (RLT). There is increasing evidence of promising response rates and a low toxicity profile with 177 Lu-labeled PSMA RLT in patients with mCRPC. A phase III randomized study of 177 Lu-labeled PSMA RLT has completed accrual and is awaiting results as to whether the drug improves radiographic progression-free survival and overall survival in men with mCRPC receiving standard of care treatments. Additional early clinical trials are investigating the role of tumor-directed targeted alpha therapy with radiotracers such as 225 Ac. In this article, we review the current status of theranostics in prostate cancer, discussing the challenges and opportunities of combination therapies with more conventional agents such as androgen receptor inhibitors, cytotoxic chemotherapy, and immunotherapy.",2021,Theranostics in men with metastatic castration-resistant prostate cancer (mCRPC) has been developed to target bone and the tumor itself.,"['men with mCRPC who have symptomatic bone metastases and no known visceral metastases', 'men with mCRPC receiving standard of care treatments', 'men with metastatic castration-resistant prostate cancer (mCRPC', '223', 'Prostate Cancer']",['177 Lu-labeled PSMA RLT'],['radiographic progression-free survival and overall survival'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0581029,Theranostics in men with metastatic castration-resistant prostate cancer (mCRPC) has been developed to target bone and the tumor itself.,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': ""O'Dwyer"", 'Affiliation': 'Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY. Electronic address: elisabethodwyer@gmail.com.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bodei', 'Affiliation': 'Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Genitourinary Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Seminars in radiation oncology,['10.1016/j.semradonc.2020.07.004']
2857,31600034,Short-Term Recovery Trajectories of Acute Flares in Knee Pain: A UK-Netherlands Multicenter Prospective Cohort Analysis.,"OBJECTIVE
To identify distinct recovery trajectories of acute flares of knee pain and associated participant characteristics.
METHODS
Data were from the FLARE randomized controlled trial, a multicenter trial in 27 primary care centers in the UK and Netherlands of 3 regimes of oral nonsteroidal antiinflammatory therapy for acute flares of knee pain. Individuals with a history of inflammatory/crystal arthritis, fibromyalgia, and chronic pain syndrome were excluded. Latent class growth analysis was applied to measures of pain intensity repeated over 5 days to identify distinct recovery trajectories. The concurrent courses of interference with activity, stiffness, and swelling for each trajectory group were modelled using generalized estimating equations. Participant age, sex, obesity, and osteoarthritis diagnosis were described for each trajectory group.
RESULTS
A total of 449 participants were included (median age 55 years, 41% female, 35% obese, and 42% diagnosed with osteoarthritis). A 6-group cubic model was deemed optimal, with trajectories distinguished by rate of pain reduction and absolute level at final measurement. At the extremes were rapid and near-complete resolution (n = 41, 9%) and persistent, high pain (n = 25, 6%), but most participants showed a reduction and plateau in pain severity within 3-5 days. Within each pain trajectory group, interference with activity, stiffness, and swelling followed the same course as pain. Baseline characteristics did not differ substantially between trajectory groups.
CONCLUSION
Even under a well-adhered to regime of oral nonsteroidal antiinflammatory medication, recovery following acute flares of knee pain is heterogeneous. Our observations that favorable trajectories are apparent within 3-5 days can help to inform treatment decision-making in the patient-health care professional consultation.",2020,"Baseline characteristics did not differ substantially between trajectory groups.
","['for acute flares of knee pain', 'A total of 449 participants were included (median age 55 years, 41% female, 35% obese, and 42% diagnosed with osteoarthritis', 'Individuals with a history of inflammatory/crystal arthritis, fibromyalgia, and chronic pain syndrome', '27 primary care centers in the UK and Netherlands of 3 regimes of']",['oral nonsteroidal antiinflammatory therapy'],"['pain severity', 'pain intensity', 'interference with activity, stiffness, and swelling followed the same course as pain']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0152087', 'cui_str': 'Crystal arthropathy'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C1298685', 'cui_str': 'Chronic pain syndrome'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096024', 'cui_str': 'Antiinflammatory therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",449.0,0.0592795,"Baseline characteristics did not differ substantially between trajectory groups.
","[{'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Thomas', 'Affiliation': 'Keele University, Haywood Academic Rheumatology Centre, Midlands Partnership NHS Foundation Trust, and Haywood Hospital, Burslem, Staffordshire, UK.'}, {'ForeName': 'Dahai', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Keele University, Staffordshire, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Nicholls', 'Affiliation': 'Keele University, Staffordshire, UK.'}, {'ForeName': 'Sita', 'Initials': 'S', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'Erasmus MC-University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Stoner', 'Affiliation': 'Infirst Healthcare Ltd, London, UK.'}, {'ForeName': 'Tuhina', 'Initials': 'T', 'LastName': 'Neogi', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Parry', 'Affiliation': 'Keele University, Staffordshire, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Peat', 'Affiliation': 'Keele University, Staffordshire, UK.'}]",Arthritis care & research,['10.1002/acr.24088']
2858,33247645,Randomized Comparative Clinical Study of First Global Omalizumab Biosimilar with Innovator Product in Moderate to Severe Persistent Asthma.,"Purpose of study
Omalizumab the first anti-IgE antibody is proven with several real-world studies and meta-analyses as important adjuvant in severe allergic asthma. This study was undertaken for the first omalizumab biosimilar to establish clinical biosimilarity and interchangeability with originator product.
Materials and Methods
In this randomized, double-blind comparative study 105 subjects (70 subjects in the study group and 35 subjects in the reference group) were dosed up to week 16 as double blind phase and responders entered open label phase till week 24. All responders at week 16 received study product in open-label phase of the study as per their dosing schedule till week 24. The additional efficacy assessment visit was performed till week 24. Safety follow up visit was performed in responders at week 26. The pharmacokinetic (PK) and pharmacodynamic (PD) assessment was planned in 48 subjects after first dose of omalizumab.
Results
In double blind phase, 4 (5.80%) asthma exacerbations were reported in study arm compared to 1 (2.86%) asthma exacerbation in reference arm with no statistically significant difference (p>0.05). The time to first asthma exacerbation was 53 days in study arm compared to 62 days in reference arm. In study and reference arm, the mean change from baseline in forced expiratory volume in one second (FEV1%) was 7.51 and 5.98 at week 4; and 12.30 and 8.94 at week 16 respectively while mean change from baseline in forced expiratory volume in one second/forced vital capacity (FEV1/FVC%) was 4.20 and 4.06 at week 4 and 6.77 and 7.10 at week 16 respectively (no statistically significant difference, p>0.05). At week 16, 4 (5.80%) subjects in study arm had 50-75% inhaled corticosteroids (ICS) dose reduction compared to 2 (5.71%) subjects in reference arm. The proportion of subjects with meaningful improvement in Asthma Quality of Life Questionnaire (AQLQ) (improvement in overall AQLQ score ≥0.5), mean change in overall Asthma Control Questionnaire (ACQ) score and proportion of responders based on Global evaluation of treatment effectiveness (GETE) assessment also was similar at 16 weeks. A total of 101 adverse events were reported out of which 63 were reported in the study or biosimilar arm and 38 were reported in the reference or innovator arm. Two serious adverse events (SAEs) were reported, one in each arm. No deaths occurred during this study and the safety observations are consistent with the known safety profile of omalizumab. All the samples analysed in this study were negative for anti-omalizumab antibodies. There was no significant difference in the PK and PD evaluation.
Conclusion
The evaluation of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity was concluded to show no meaningful clinical difference of the biosimilar omalizumab with the reference product.",2020,"The proportion of subjects with meaningful improvement in Asthma Quality of Life Questionnaire (AQLQ) (improvement in overall AQLQ score ≥0.5), mean change in overall Asthma Control Questionnaire (ACQ) score and proportion of responders based on Global evaluation of treatment effectiveness (GETE) assessment also was similar at 16 weeks.","['severe allergic asthma', '48 subjects after first dose of omalizumab', 'Moderate to Severe Persistent Asthma', '105 subjects (70 subjects in the study group and 35 subjects in the reference group']",['inhaled corticosteroids (ICS'],"['pharmacokinetic (PK) and pharmacodynamic (PD) assessment', 'forced expiratory volume', 'time to first asthma exacerbation', 'asthma exacerbations', 'deaths', 'Asthma Quality of Life Questionnaire (AQLQ', 'overall Asthma Control Questionnaire (ACQ) score', 'pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity', 'forced vital capacity (FEV1/FVC', 'PK and PD evaluation']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",105.0,0.0952017,"The proportion of subjects with meaningful improvement in Asthma Quality of Life Questionnaire (AQLQ) (improvement in overall AQLQ score ≥0.5), mean change in overall Asthma Control Questionnaire (ACQ) score and proportion of responders based on Global evaluation of treatment effectiveness (GETE) assessment also was similar at 16 weeks.","[{'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Apsangikar', 'Affiliation': 'Head Medical Affairs, Reliance Life Sciences Pvt. Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Ghadge', 'Affiliation': 'Head Clinical Research, Reliance Life Sciences Pvt. Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Naik', 'Affiliation': 'Head Pharmacovigilance, Reliance Life Sciences Pvt. Ltd., Mumbai, Maharashtra.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': 'Divisional Medical Head, Reliance Life Sciences Pvt. Ltd., Mumbai, Maharashtra.'}]",The Journal of the Association of Physicians of India,[]
2859,33247691,Efficacy of Oral Vitamin A in Reducing β-hCG Levels in Low-Risk Gestational Trophoblastic Neoplasia Patients.,"OBJECTIVE
Low-risk gestational trophoblastic neoplasia (GTN) is generally treated with single agent chemotherapy and methotrexate (MTX) as a first-line therapy. Vitamin A helps to increase trophoblast cell regression, as well as to decrease β-hCG levels. Vitamin A also increases the effectiveness of MTX by inducing more malignant cell death than MTX alone. Therefore, the aim of the current study was to analyze the changes in β-hCG levels in low-risk GTN patients following vitamin A administration.
METHODS
This study was a randomized clinical trial, which examined initial serum vitamin A and β-hCG levels in GTN patients before and after three cycles of MTX therapy. Patients were given vitamin A supplementation of 6,000 IU (1.8 mg RAEs) per day, and the changes in serum β-hCG were observed after three cycles. Patients were grouped by β-hCG levels (decreased or stagnant).
RESULTS
A total of 32 low-risks GTN patients were divided into the intervention group (16 patients who received vitamin A supplementation) and the control group (16 patients who did not receive vitamin A supplementation). In the intervention group, the average initial β-hCG level was 170,949.3 ± 354,452.1 mIU/mL, and the average β-hCG post-cycle level was 1,611.9 ± 3,652.5 mIU/mL. In the control group, the average initial β-hCG level was 178,834.1 ± 2913844.6 mIU/mL, and the average β-hCG post-cycle level was 25,388.5 ± 58,437.7 mIU/mL.
CONCLUSION
In patients with low-risk GTN who underwent MTX chemotherapy, the levels of β-hCG and the incidence of chemo resistance in the intervention group were lower than those in the control group. Older age may also influence the incidence of chemo resistance in GTN patients. Oral administration of 6,000 IU vitamin A could help to reduce β-hCG levels in low-risk GTN patients who receive MTX chemotherapy.
.",2020,"In the intervention group, the average initial β-hCG level was 170,949.3 ± 354,452.1 mIU/mL, and the average β-hCG post-cycle level was 1,611.9 ± 3,652.5 mIU/mL. In the control group, the average initial β-hCG level was 178,834.1 ± 2913844.6 mIU/mL, and the average β-hCG post-cycle level was 25,388.5 ± 58,437.7 mIU/mL.
CONCLUSION
In patients with low-risk GTN who underwent MTX chemotherapy, the levels of β-hCG and the incidence of chemo resistance in the intervention group were lower than those in the control group.","['low-risk GTN patients who receive MTX chemotherapy.
40%) with and without type 2 diabetes mellitus (T2DM) have been enrolled. Patients were required to have elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations (i.e. >300 pg/mL in patients without and >900 pg/mL in patients with atrial fibrillation) along with evidence of structural changes in the heart or documented history of HF hospitalization.
RESULTS
Among patients enrolled from various regions (45% Europe, 11% Asia, 25% Latin America, 12% North America), the mean age was 72±9 years, 45% were women. Almost all patients had New York Heart Association (NYHA) Class II or III symptoms (99.6%), and 23% had prior HF hospitalization within 12 months. Thirty-three percent of the patients had baseline LVEF of 41-50%. The mean LVEF (54±9%) was slightly lower while the median NT-proBNP (974 [499-1731] pg/mL) was higher compared with previous HFpEF trials. Presence of comorbidities such as diabetes (49%) and chronic kidney disease (50%) were common. The majority of the patients were on angiotensin converting enzyme inhibitors/angiotensin receptor blockers/ARNi's (80%) and beta-blockers (86%), and 37% of patients were on mineralocorticoid receptor antagonists.
CONCLUSION
When compared with prior trials in HFpEF, the EMPEROR-Preserved cohort has a somewhat higher burden of co-morbidities, lower LVEF, higher median NT-proBNP and greater use of mineralocorticoid receptor antagonists at baseline. Results of the EMPEROR-Preserved trial will be available in 2021. This article is protected by copyright. All rights reserved.",2020,The mean LVEF (54±9%) was slightly lower while the median NT-proBNP (974 [499-1731] pg/mL) was higher compared with previous HFpEF trials.,"['patients enrolled from various regions (45% Europe, 11% Asia, 25% Latin America, 12% North America), the mean age was 72±9\u2009years, 45% were women', 'patients with heart failure with preserved ejection fraction (HFpEF', 'Patients were required to have elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) concentrations (i.e. >300 pg/mL in patients without and >900 pg/mL in patients with atrial fibrillation) along with evidence of structural changes in the heart or documented history of HF hospitalization', '5988 symptomatic HFpEF patients (left ventricular ejection fraction [LVEF] >40%) with and without type 2 diabetes mellitus (T2DM) have been enrolled', 'Almost all patients had New York Heart Association (NYHA) Class II or III symptoms (99.6%), and 23% had prior HF hospitalization within 12 months', 'Patients with Heart Failure with Preserved Ejection Fraction in the EMPEROR-Preserved Trial', 'patients enrolled in prior HFpEF trials']","['empagliflozin', 'placebo']","['mean LVEF', 'chronic kidney disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0023122', 'cui_str': 'Latin America'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]",5988.0,0.351546,The mean LVEF (54±9%) was slightly lower while the median NT-proBNP (974 [499-1731] pg/mL) was higher compared with previous HFpEF trials.,"[{'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT), German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'University of Mississippi School of Medicine, Jackson, MI, USA.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodistrian University of Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Muhammad Shahzeb', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': 'University of Mississippi School of Medicine, Jackson, MI, USA.'}, {'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, Nancy, France.'}, {'ForeName': 'Edimar', 'Initials': 'E', 'LastName': 'Bocchi', 'Affiliation': 'São Paulo University Medical School, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes, Homberg, Germany.'}, {'ForeName': 'Hans Pieter Brunner-La', 'Initials': 'HPB', 'LastName': 'Rocca', 'Affiliation': 'Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Dong-Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': 'Medanta Medicity to Max Superspeciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Chuquiure', 'Affiliation': 'Instituto Nacional de Cardiologia Ignacio Chavez, Ciudad de Mexico, Mexico.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Giannetti', 'Affiliation': 'Centre universitaire de sante McGill, Montreal, Quebec, Canada.'}, {'ForeName': 'Juan Esteban', 'Initials': 'JE', 'LastName': 'Gomez-Mesa', 'Affiliation': 'Fundación Valle del Lili, Cali, Colombia.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Janssens', 'Affiliation': 'Leuven, Belgium, University Hospitals, Brazil.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Harvard Medical School, Massachusetts, General Hospital, Boston, USA.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Gonzalez-Juanatey', 'Affiliation': 'Complejo Hospitalario Universitario de Santiago, CIBERCV, A Coruña, Spain.'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Nicholls', 'Affiliation': 'Victorian Heart Institute, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Sergio V', 'Initials': 'SV', 'LastName': 'Perrone', 'Affiliation': 'Department of Cardiology, FLENI Institute, Buenos Aires, Argentina.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wrocław Medical University, Wroclaw, Poland.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'ASST Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Seronde', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Besançon, Besançon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sim', 'Affiliation': 'National Heart Centre, Singapore.'}, {'ForeName': 'Jindrich', 'Initials': 'J', 'LastName': 'Spinar', 'Affiliation': 'University Hospital, Masaryk University Hospital, Brno.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Squire', 'Affiliation': 'NIHR Cardiovascular Biomedical Research Centre, Glenfield Hospital, Leicester, UK.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Taddei', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': 'Kyushu University, Fukuoka, City, Japan.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila; University and Emergency Hospital, Bucharest, Romania.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Fuwai Hospital Chinese Academic of Medical Science, Beijing, China.'}, {'ForeName': 'Waheed', 'Initials': 'W', 'LastName': 'Jamal', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Schnee', 'Affiliation': 'Boehringer Ingelheim Pharma., Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Pocock', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'Université de Lorraine, Inserm INI-CRCT, Nancy, France.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor University Medical Center, Dallas, TX USA and Imperial College, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.2064']
2863,33251662,"Analgesic Efficacy of ""Burst"" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study.","OBJECTIVES
The aim of this study was to compare the efficacy in reducing pain intensity in adult subjects suffering from chronic back and leg pain of burst (BST) and tonic sub-threshold stimulation at 500 Hz (T500) vs. sham stimulation delivered by a spinal cord stimulation (SCS) device capable of automated postural adjustment of current intensity.
MATERIALS AND METHODS
A multicentre randomized double-blind, three-period, three-treatment, crossover study was undertaken at two centers in the United Kingdom. Patients who had achieved stable pain relief with a conventional SCS capable of automated postural adjustment of current intensity were randomized to sequences of BST, T500, and sham SCS with treatment order balanced across the six possible sequences. A current leakage was programmed into the implantable pulse generator (IPG) in the sham period. The primary outcome was patient reported pain intensity using a visual analog scale (VAS).
RESULTS
Nineteen patients were enrolled and randomized. The mean reduction in pain with T500 was statistically significantly greater than that observed with either sham (25%; 95% CI, 8%-38%; p = 0.008) or BST (28%; 95% CI, 13%-41%; p = 0.002). There were no statistically significant differences in pain VAS for BST versus Sham (5%; 95% CI, -13% to 27%; p = 0.59). Exploratory sub-group analyses by study site and sex were also conducted for the T500 vs. sham and BST versus sham comparisons.
CONCLUSIONS
The findings suggest a superior outcome versus sham from T500 stimulation over BST stimulation and a practical equivalence between BST and sham in a group of subjects with leg and back pain habituated to tonic SCS and having achieved a stable status with stimulation.",2020,"There were no statistically significant differences in pain VAS for BST versus Sham (5%; 95% CI, -13% to 27%; p = 0.59).","['two centers in the United Kingdom', 'adult subjects suffering from chronic back and leg pain of burst (BST) and tonic sub-threshold stimulation at 500 Hz (T500) vs', 'Nineteen patients were enrolled and randomized', 'Patients who had achieved stable pain relief with a conventional SCS capable of automated postural adjustment of current intensity']","['sham stimulation delivered by a spinal cord stimulation (SCS) device capable of automated postural adjustment of current intensity', 'Placebo', 'BST', 'Burst"" and Tonic (500 Hz) Spinal Cord Stimulation Patterns']","['Analgesic Efficacy', 'pain VAS', 'mean reduction in pain', 'pain intensity', 'pain intensity using a visual analog scale (VAS']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",19.0,0.605886,"There were no statistically significant differences in pain VAS for BST versus Sham (5%; 95% CI, -13% to 27%; p = 0.59).","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Duarte', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Gulve', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': 'Department of Pain Management, Newcastle-upon-Tyne NHS Trust, Newcastle, UK.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Garner', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Brookes', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Madzinga', 'Affiliation': 'Department of Clinical Research Services, ICON Group, Sydney, Australia.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Buchser', 'Affiliation': 'Department of Anaesthesia and Pain Management, EHC - Hôpital de Morges, Morges, Switzerland.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Batterham', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, UK.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13321']
2864,33251650,"Evaluating the efficacy and safety of topical sirolimus 0.2% cream as adjuvant therapy with pulsed dye laser for the treatment of port wine stain: A randomized, double-blind, placebo-controlled trial.","INTRODUCTION
Port Wine Stain (PWS) is a congenital capillary malformation. Although multiple treatments are required, the gold standard treatment for PWS is Pulsed Dye Laser (PDL). Given its anti-angiogenic effects, sirolimus can be considered as an adjuvant to PDL in PWS.
AIM
To evaluate the efficacy and safety of topical sirolimus (Rapamycin) 0.2% cream as adjuvant therapy for PDL for PWS.
METHODS
In this randomized double-blind placebo-controlled trial, 15 patients with PWS were enrolled. Each lesion was divided into upper and lower parts, and each part was assigned randomly to receive PDL (4 sessions, 2 months apart) plus sirolimus versus PDL and placebo. The response was evaluated using colorimetry, investigator global assessment (IGA), and patient global assessment (PGA) every two months for eight continuous months.
RESULTS
According to the colorimetric analysis, medial and lateral sides of the treatment and placebo parts did not differ significantly (both P-value>0.05). However, according to PGA and IGA, there was a significant difference in favor of sirolimus (P-values= 0.041 and 0.039, respectively). Itching and dryness (86.7%), contact dermatitis (20%) were the most common adverse effects in the sirolimus group, while none of them were observed in placebo.
CONCLUSION
Although the improvement was significant subjectively, topical sirolimus 0.2% as an adjuvant to PDL does not appear to improve PWS erythema using calorimetric assessment.",2020,"Itching and dryness (86.7%), contact dermatitis (20%) were the most common adverse effects in the sirolimus group, while none of them were observed in placebo.
","['15 patients with PWS were enrolled', 'port wine stain']","['placebo', 'pulsed dye laser', 'Pulsed Dye Laser (PDL', 'PDL', 'sirolimus versus PDL and placebo', 'Port Wine Stain (PWS', 'topical sirolimus 0.2% cream', 'topical sirolimus (Rapamycin', 'sirolimus']","['contact dermatitis', 'colorimetry, investigator global assessment (IGA), and patient global assessment (PGA', 'PWS erythema', 'efficacy and safety', 'adverse effects', 'Itching and dryness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1289859', 'cui_str': 'Pulsed dye laser device'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0700385', 'cui_str': 'Cream'}]","[{'cui': 'C0011616', 'cui_str': 'Contact dermatitis'}, {'cui': 'C0009407', 'cui_str': 'Colorimetry'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206733', 'cui_str': 'Strawberry nevus of skin'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033774', 'cui_str': 'Itching'}]",15.0,0.133765,"Itching and dryness (86.7%), contact dermatitis (20%) were the most common adverse effects in the sirolimus group, while none of them were observed in placebo.
","[{'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Fallahi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hallaji', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Tavakolpour', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Niknam', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Salehi Farid', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nili', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Teimourpour', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences Tehran, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Daneshpazhooh', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Rahmati', 'Affiliation': 'Department of plastic and reconstructive surgery, Imam Khomeini Hospital and Razi Hospital, Tehran University of Medical Sciences Tehran, Tehran, Iran.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Haddady Abianeh', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Mahmoudi', 'Affiliation': 'Autoimmune Bullous Diseases Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13867']
2865,33248746,"Influence of Lumbar Mobilizations During the Nordic Hamstring Exercise on Hamstring Measures of Knee Flexor Strength, Failure Point, and Muscle Activity: A Randomized Crossover Trial.","OBJECTIVE
The aims of this study were to quantify the effects of spinal mobilization on force production, failure point, and muscle activity of the hamstrings during the Nordic hamstring exercise (NHE), and to explore individual differences in responses.
METHODS
In a replicated randomized crossover trial, 24 asymptomatic, recreationally active men (age [mean ± standard deviation]: 27 ± 6 years; body mass: 82 ± 17 kg; height: 181 ± 8 cm) completed 2 standardized intervention trials (L4/5 zygapophyseal mobilizations) and 2 control trials. The failure point of the NHE was determined with 3D motion capture. Peak force, knee flexor torque, and electromyography (EMG) of the biceps femoris were measured. Data analyses were undertaken to quantify mean intervention response and explore any individual response heterogeneity.
RESULTS
Mean (95% confidence interval) left-limb force was higher in intervention than in control trials by 18.7 (4.6-32) N. Similarly, right-limb force was higher by 22.0 (3.4-40.6) N, left peak torque by 0.14 (0.06-0.22) N • m, and right peak torque by 0.14 (0.05-0.23) N • m/kg. Downward force angle was decreased in intervention vs control trials by 4.1° (0.5°-7.6°) on the side of application. Both peak EMG activity (P = .002), and EMG at the downward force (right; P = .020) increased in the intervention condition by 16.8 (7.1-26.4) and 8.8 (1.5-16.1) mV, respectively. Mean downward acceleration angle changed by only 0.3° (-8.9° to 9.4°) in intervention vs control trials. A clear response heterogeneity was indicated only for right force (Participant × Intervention interaction: P = .044; response heterogeneity standard deviation = 34.5 [5.7-48.4] N). Individual response heterogeneity was small for all other outcomes.
CONCLUSION
After spinal mobilization, immediate changes in bilateral hamstring force production and peak torque occurred during the NHE. The effect on the NHE failure point was unclear. Electromyographic activity increased on the ipsilateral side. Response heterogeneity was generally similar to the random trial-to-trial variability inherent in the measurement of the outcomes.",2020,Mean (95% confidence interval) left-limb force was higher in intervention than in control trials by 18.7,"['24 asymptomatic, recreationally active men (age [mean ± standard deviation]: 27 ± 6 years; body mass: 82 ± 17 kg; height: 181 ± 8 cm) completed 2 standardized intervention trials (L4/5 zygapophyseal mobilizations) and 2 control trials']","['Lumbar Mobilizations', 'Nordic hamstring exercise (NHE', 'Nordic Hamstring Exercise', 'spinal mobilization']","['left peak torque', 'right-limb force', 'Mean downward acceleration angle', 'Peak force, knee flexor torque, and electromyography (EMG) of the biceps femoris', 'Hamstring Measures of Knee Flexor Strength, Failure Point, and Muscle Activity', 'Response heterogeneity', 'Electromyographic activity', 'right peak torque', 'left-limb force', 'bilateral hamstring force production and peak torque', 'force production, failure point, and muscle activity', 'peak EMG activity']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205104', 'cui_str': 'Down'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]",24.0,0.0836326,Mean (95% confidence interval) left-limb force was higher in intervention than in control trials by 18.7,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chesterton', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom. Electronic address: p.chesterton@tees.ac.uk.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Evans', 'Affiliation': 'Faculty of Health Sciences and Wellbeing, Sunderland University, Sunderland, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Lolli', 'Affiliation': 'Football Exchange, Research Institute of Sport Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Richardson', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Atkinson', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, United Kingdom.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2020.09.005']
2866,33248743,"Assessing barriers to providing tobacco use disorder treatment in community mental health settings with a revised version of the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument.","BACKGROUND
Tobacco use disorder (TUD) rates are 2-3 times higher among people with serious mental illness (SMI) than the general population. Clinicians working in outpatient community mental health clinics are well positioned to provide TUD treatment to this group, but rates of treatment provision are very low. Understanding factors associated with the provision of TUD treatment by mental health clinicians is a priority.
METHODS
This study used baseline data from an ongoing cluster-randomized clinical trial evaluating two approaches to training clinicians to increase TUD treatment. Following a psychometric assessment of our assessment tool, the Smoking Knowledge, Attitudes, and Practices (S-KAP) instrument, a new factor structure was evaluated utilizing confirmatory factor analysis. Structural equation modeling was then used to examine the associations between TUD treatment practices and clinician, setting, and patient characteristics in a sample of 182 mental health clinicians across 10 mental health clinics.
RESULTS
Clinician but not setting or patient characteristics emerged as significant correlates of providing TUD treatment. Specifically, clinicians' general ethical commitment to providing TUD services and perceptions of their skills in providing this type of care were associated with providing TUD treatment. In contrast, clinician perceptions of patient motivation, anticipated quit rates, or available setting resources were not significantly associated with providing TUD treatment.
CONCLUSIONS
Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI. Future studies should evaluate interventions that target these factors.",2020,"CONCLUSIONS
Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI.","['outpatient community mental health clinics', '182 mental health clinicians across 10 mental health clinics', 'people with serious mental illness (SMI) than the general population', 'people with SMI']",[],"['TUD rates', 'quit rates, or available setting resources']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0040336', 'cui_str': 'Tobacco abuse'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",182.0,0.0630986,"CONCLUSIONS
Enhancing community mental health clinician TUD treatment skills and commitment to providing such services may reduce TUD rates among people with SMI.","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Siegel', 'Affiliation': 'Value Institute and Helen F. Graham Cancer Center & Research Institute, Christiana Care Health System, United States. Electronic address: ssiegel@christianacare.org.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Laurenceau', 'Affiliation': 'Department of Psychological & Brain Sciences, University of Delaware, United States.'}, {'ForeName': 'Naja', 'Initials': 'N', 'LastName': 'Hill', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Anna-Marika', 'Initials': 'AM', 'LastName': 'Bauer', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Flitter', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Ziedonis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, United States.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Hosie Quinn', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Pulmonary, Allergy, & Critical Care Division, University of Pennsylvania, United States.'}, {'ForeName': 'Rinad', 'Initials': 'R', 'LastName': 'Beidas', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States; Department of Medical Ethics and Health Policy, Penn Implementation Science Center at the Leonard Davis Institute (PISCE@LDI), United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kimberly', 'Affiliation': 'The Wharton School of Business, University of Pennsylvania, United States.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106735']
2867,33252690,"Effect of a Low-Fat Vegan Diet on Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels in Overweight Adults: A Randomized Clinical Trial.","Importance
Excess body weight and insulin resistance lead to type 2 diabetes and other major health problems. There is an urgent need for dietary interventions to address these conditions.
Objective
To measure the effects of a low-fat vegan diet on body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels in overweight adults.
Design, Setting, and Participants
This 16-week randomized clinical trial was conducted between January 2017 and February 2019 in Washington, DC. Of 3115 people who responded to flyers in medical offices and newspaper and radio advertisements, 244 met the participation criteria (age 25 to 75 years; body mass index of 28 to 40) after having been screened by telephone.
Interventions
Participants were randomized in a 1:1 ratio. The intervention group (n = 122) was asked to follow a low-fat vegan diet and the control group (n = 122) to make no diet changes for 16 weeks.
Main Outcomes and Measures
At weeks 0 and 16, body weight was assessed using a calibrated scale. Body composition and visceral fat were measured by dual x-ray absorptiometry. Insulin resistance was assessed with the homeostasis model assessment index and the predicted insulin sensitivity index (PREDIM). Thermic effect of food was measured by indirect calorimetry over 3 hours after a standard liquid breakfast (720 kcal). In a subset of participants (n = 44), hepatocellular and intramyocellular lipids were quantified by proton magnetic resonance spectroscopy. Repeated measure analysis of variance was used for statistical analysis.
Results
Among the 244 participants in the study, 211 (87%) were female, 117 (48%) were White, and the mean (SD) age was 54.4 (11.6) years. Over the 16 weeks, body weight decreased in the intervention group by 5.9 kg (95% CI, 5.0-6.7 kg; P < .001). Thermic effect of food increased in the intervention group by 14.1% (95% CI, 6.5-20.4; P < .001). The homeostasis model assessment index decreased (-1.3; 95% CI, -2.2 to -0.3; P < .001) and PREDIM increased (0.9; 95% CI, 0.5-1.2; P < .001) in the intervention group. Hepatocellular lipid levels decreased in the intervention group by 34.4%, from a mean (SD) of 3.2% (2.9%) to 2.4% (2.2%) (P = .002), and intramyocellular lipid levels decreased by 10.4%, from a mean (SD) of 1.6 (1.1) to 1.5 (1.0) (P = .03). None of these variables changed significantly in the control group over the 16 weeks. The change in PREDIM correlated negatively with the change in body weight (r = -0.43; P < .001). Changes in hepatocellular and intramyocellular lipid levels correlated with changes in insulin resistance (both r = 0.51; P = .01).
Conclusions and Relevance
A low-fat plant-based dietary intervention reduces body weight by reducing energy intake and increasing postprandial metabolism. The changes are associated with reductions in hepatocellular and intramyocellular fat and increased insulin sensitivity.
Trial Registration
ClinicalTrials.gov Identifier: NCT02939638.",2020,"Thermic effect of food increased in the intervention group by 14.1% (95% CI, 6.5-20.4; P < .001).","['Overweight Adults', '244 participants in the study, 211 (87%) were female, 117 (48%) were White, and the mean (SD) age was 54.4 (11.6) years', 'overweight adults', 'January 2017 and February 2019 in Washington, DC', '3115 people who responded to flyers in medical offices and newspaper and radio advertisements, 244 met the participation criteria (age 25 to 75 years; body mass index of 28 to 40) after having been screened by telephone']","['low-fat vegan diet', 'low-fat vegan diet and the control group (n\u2009=\u2009122) to make no diet changes for 16 weeks', 'Low-Fat Vegan Diet']","['hepatocellular and intramyocellular lipids', 'insulin resistance', 'Body composition and visceral fat', 'body weight', 'Changes in hepatocellular and intramyocellular lipid levels', 'homeostasis model assessment index', 'homeostasis model assessment index and the predicted insulin sensitivity index (PREDIM', 'Hepatocellular lipid levels', 'hepatocellular and intramyocellular fat and increased insulin sensitivity', 'intramyocellular lipid levels', 'Thermic effect of food', 'Body Weight, Insulin Sensitivity, Postprandial Metabolism, and Intramyocellular and Hepatocellular Lipid Levels', 'Insulin resistance', 'body weight, insulin resistance, postprandial metabolism, and intramyocellular and hepatocellular lipid levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0344353', 'cui_str': 'Vegan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",,0.0881457,"Thermic effect of food increased in the intervention group by 14.1% (95% CI, 6.5-20.4; P < .001).","[{'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Kahleova', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}, {'ForeName': 'Kitt Falk', 'Initials': 'KF', 'LastName': 'Petersen', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Gerald I', 'Initials': 'GI', 'LastName': 'Shulman', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jihad', 'Initials': 'J', 'LastName': 'Alwarith', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Rembert', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padua, Italy.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Institute of Endocrinology, Prague, Czech Republic.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Holubkov', 'Affiliation': 'School of Medicine, University of Utah, Salt Lake City.'}, {'ForeName': 'Neal D', 'Initials': 'ND', 'LastName': 'Barnard', 'Affiliation': 'Physicians Committee for Responsible Medicine, Washington, DC.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.25454']
2868,33252671,Hospital Consultation From Outpatient Clinicians for Medically Complex Children: A Randomized Clinical Trial.,"Importance
Children with medical complexity (CMC) frequently experience fragmented care. We have demonstrated that outpatient comprehensive care (CC) reduces serious illnesses, hospitalizations, and costs for high-risk CMC. Yet continuity of care for CMC is often disrupted with emergency department (ED) visits and hospitalizations.
Objective
To evaluate a hospital consultation (HC) service for CMC from their outpatient CC clinicians.
Design, Setting, and Participants
Randomized quality improvement trial at the University of Texas Health Science Center at Houston with an outpatient CC clinic and tertiary pediatric hospital (Children's Memorial Hermann Hospital). Participants included high-risk CMC (≥2 hospitalizations or ≥1 pediatric intensive care unit [PICU] admission in the year before enrolling in our clinic) receiving CC. Data were analyzed between January 11, 2018, and December 20, 2019.
Interventions
The HC included serial discussions between CC clinicians, ED physicians, and hospitalists addressing need for admission, inpatient treatment, and transition back to outpatient care. Usual hospital care (UHC) involved routine pediatric hospitalist care.
Main Outcomes and Measures
Total hospital days (primary outcome), PICU days, hospitalizations, and health system costs in skeptical bayesian analyses (using a prior probability assuming no benefit).
Results
From October 3, 2016, through October 2, 2017, 342 CMC were randomized to either HC (n = 167) or UHC (n = 175) before meeting the predefined bayesian stopping guideline (>80% probability of reduced hospital days). In intention-to-treat analyses, the probability that HC reduced total hospital days was 91% (2.72 vs 6.01 per child-year; bayesian rate ratio [RR], 0.61; 95% credible interval [CrI], 0.30-1.26). The probability of a reduction with HC vs UHC was 98% for hospitalizations (0.60 vs 0.93 per child-year; RR, 0.68; 95% CrI, 0.48-0.97), 89% for PICU days (0.77 vs 1.89 per child-year; RR, 0.59; 95% CrI, 0.26-1.38), and 94% for mean total health system costs ($24 928 vs $42 276 per child-year; cost ratio, 0.67; 95% CrI, 0.41-1.10). In secondary analysis using a bayesian prior centered at RR of 0.78, reflecting the opinion of 7 experts knowledgeable about CMC, the probability that HC reduced hospital days was 96%.
Conclusions and Relevance
Among CMC receiving comprehensive outpatient care, an HC service from outpatient clinicians likely reduced total hospital days, hospitalizations, PICU days, other outcomes, and health system costs. Additional trials of an HC service from outpatient CC clinicians are needed for CMC in other centers.
Trial Registration
ClinicalTrials.gov Identifier: NCT02870387.",2020,"In intention-to-treat analyses, the probability that HC reduced total hospital days was 91% (2.72 vs 6.01 per child-year; bayesian rate ratio [RR], 0.61; 95% credible interval [CrI], 0.30-1.26).","[""University of Texas Health Science Center at Houston with an outpatient CC clinic and tertiary pediatric hospital (Children's Memorial Hermann Hospital"", 'Importance\n\n\nChildren with medical complexity (CMC', 'Participants included high-risk CMC (≥2 hospitalizations or ≥1 pediatric intensive care unit [PICU] admission in the year before enrolling in our clinic) receiving', 'Medically Complex Children', 'Results\n\n\nFrom October 3, 2016, through October 2, 2017, 342 CMC']","['UHC', 'CC', 'HC', 'Usual hospital care (UHC', 'hospital consultation (HC) service']","['total hospital days, hospitalizations, PICU days, other outcomes, and health system costs', 'probability that HC reduced total hospital days', 'mean total health system costs', 'Measures\n\n\nTotal hospital days (primary outcome), PICU days, hospitalizations, and health system costs in skeptical bayesian analyses (using a prior probability assuming no benefit']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C5191280', 'cui_str': '342'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242196', 'cui_str': 'Analysis, Bayesian'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",342.0,0.140731,"In intention-to-treat analyses, the probability that HC reduced total hospital days was 91% (2.72 vs 6.01 per child-year; bayesian rate ratio [RR], 0.61; 95% credible interval [CrI], 0.30-1.26).","[{'ForeName': 'Ricardo A', 'Initials': 'RA', 'LastName': 'Mosquera', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Elenir B C', 'Initials': 'EBC', 'LastName': 'Avritscher', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Pedroza', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Cynthia S', 'Initials': 'CS', 'LastName': 'Bell', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Samuels', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Tomika S', 'Initials': 'TS', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Eapen', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Poe', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Raymond L', 'Initials': 'RL', 'LastName': 'Parlar-Chun', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Berry', 'Affiliation': ""Complex Care Service, Division of General Pediatrics, Boston Children's Hospital, Department of Pediatrics, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Jon E', 'Initials': 'JE', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School, The University of Texas Health Science Center at Houston.'}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.5026']
2869,33252635,Clinical Translation of Scarless 0.33mm Core Microbiopsy for Molecular Evaluation of Human Skin.,"BACKGROUND
Skin scarring can occur after punch biopsies, prohibiting their routine use especially in the central face.
OBJECTIVES
This paper describes a scarless 0.33mm in diameter skin microbiopsy for molecular analysis of skin.
METHODS
This is a single center, randomized, prospective study with fifteen subjects receiving no biopsy, or biopsy on the left or right nasolabial fold. Six blinded raters assessed subject photos at baseline, one month, and three months post biopsy to evaluate for a visualized scar. Patient and Observer Scar Assessment Scale (POSAS) was completed. Additionally, biopsies from various skin regions of body along with arm skin after treatment with a single Erbium-YAG laser were processed for molecular analysis.
RESULTS
All subjects did not exhibit scar formation based on evaluation of photographs and patient feedback. There was no mark at the biopsy site seven days post-procedure. Optical Coherence Tomography showed a complete closing of the biopsy-punch wound 48-hours post-biopsy. One-month post-biopsy, photography reviewers were unable to identify a scar, on average, 90% of the time at three-month follow-up. Microbiopsies from various anatomical regions were successfully extracted for histology, electron microscopy and gene expression analysis. Selected skin rejuvenation markers in the biopsies from Erbium-YAG treated forearm skin resulted in significant gene upregulation in extracellular matrix molecules following one-month post treatment compare to untreated skin.
CONCLUSIONS
A core micro-biopsy of 0.33mm can be extracted reproducibly for histological, ultrastructural and gene expression analysis without scarring. This allows repeated sampling for assessment of skin treatments and diseases including aesthetics and wound healing progress.",2020,"Selected skin rejuvenation markers in the biopsies from Erbium-YAG treated forearm skin resulted in significant gene upregulation in extracellular matrix molecules following one-month post treatment compare to untreated skin.
","['fifteen subjects receiving no biopsy, or biopsy on the left or right nasolabial fold', 'Human Skin']",['Optical Coherence Tomography'],"['extracellular matrix molecules', 'Patient and Observer Scar Assessment Scale (POSAS']","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0221328', 'cui_str': 'Nasolabial sulcus structure'}, {'cui': 'C3859811', 'cui_str': 'human skin preparation'}]","[{'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}]","[{'cui': 'C0015350', 'cui_str': 'Matrix, Extracellular'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]",,0.0246078,"Selected skin rejuvenation markers in the biopsies from Erbium-YAG treated forearm skin resulted in significant gene upregulation in extracellular matrix molecules following one-month post treatment compare to untreated skin.
","[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Kislevitz', 'Affiliation': 'Resident, Department of General Surgery, MedStar Georgetown University Hospital, Washington, DC, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wamsley', 'Affiliation': 'Medical Student Research Fellow, Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Mason', 'Initials': 'M', 'LastName': 'Bartels', 'Affiliation': 'Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Lu', 'Affiliation': 'Resident, Division of Plastic Surgery, UT Medical Branch, Galveston, TX.'}, {'ForeName': 'Xingchen', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Resident, Division of Plastic Surgery, Penn State Hershey College of Medicine, Hershey, PA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Pinch', 'Affiliation': 'Resident, Department of Obstetrics and Gynecology, UT Southwestern Medical Center, Dallas TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hoopman', 'Affiliation': 'Medical Laser Specialist, Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Barton', 'Affiliation': 'Retired Faculty, Department of Plastic Surgery, UT Southwestern Medical Center, Dallas TX.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kenkel', 'Affiliation': 'Chair, Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Yucel', 'Initials': 'Y', 'LastName': 'Akgul', 'Affiliation': 'Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, TX.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa332']
2870,33252586,"Hard-Soled Shoe Versus Short Leg Cast for a Fifth Metatarsal Base Avulsion Fracture: A Multicenter, Noninferiority, Randomized Controlled Trial.","BACKGROUND
The purpose of this study was to determine whether tolerated weight-bearing in a hard-soled shoe was noninferior to the use of a short leg cast for the treatment of a fifth metatarsal base avulsion fracture, as assessed with use of a 100-mm visual analog scale (VAS) for pain at 6 months after the fracture.
METHODS
A total of 145 patients were assessed for eligibility. Of these, 96 patients were randomly assigned to either the hard-soled shoe group (46 patients) or the cast group (50 patients). The primary outcome measure was the mean difference on the 100-mm VAS between groups at 6 months after the fracture. Secondary outcome measures included the time to return to preinjury activity and patient-reported satisfaction. Analysis was performed according to both an intention-to-treat basis (i.e., patients were included in the assessment of their assigned treatment arm, even if they crossed over to the other treatment arm prior to completing the 6-month follow-up) and a per-protocol basis (i.e., patients who completed the 6-month follow-up were analyzed according to the treatment they received).
RESULTS
At 6 months after the fracture, the mean 100-mm VAS was 8.6 ± 7.0 mm in the hard-soled shoe group and 9.8 ± 7.3 mm in the cast group (p = 0.41) according to intention-to-treat analysis. The mean difference in 100-mm VAS between the 2 groups was -1.3 mm (95% confidence interval, -4.3 to 1.8 mm). The upper limit of the 95% confidence interval did not exceed the noninferiority margin of 10 mm, indicating that treatment with the hard-soled shoe was noninferior to treatment with the short leg cast. The proportion of patients who reported satisfaction with their treatment was similar between the hard-soled shoe and cast groups (89.5% compared with 87.5%, respectively; p = 0.79), but the time to return to preinjury activity was significantly shorter in the hard-soled shoe group (37.2 ± 14.4 days compared with 43.0 ± 11.1 days in the cast group; p = 0.04). There were no cases of nonunion in either group.
CONCLUSIONS
Weight-bearing as tolerated in a hard-soled shoe for a fifth metatarsal base avulsion fracture was noninferior to the use of a short leg cast as assessed with use of a 100-mm VAS at 6 months after the fracture. Patient-reported satisfaction was similar between groups, but the time to return to preinjury activity was shorter in the hard-soled shoe group.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The proportion of patients who reported satisfaction with their treatment was similar between the hard-soled shoe and cast groups (89.5% compared with 87.5%, respectively; p = 0.79), but the time to return to preinjury activity was significantly shorter in the hard-soled shoe group (37.2 ± 14.4 days compared with 43.0 ± 11.1 days in the cast group; p = 0.04).","['for a Fifth Metatarsal Base Avulsion Fracture', 'A total of 145 patients were assessed for eligibility', '96 patients']",['Hard-Soled Shoe Versus Short Leg Cast'],"['100-mm visual analog scale (VAS) for pain', 'time to return to preinjury activity and patient-reported satisfaction', 'mean difference on the 100-mm VAS', 'mean 100-mm VAS', 'time to return to preinjury activity', 'mean difference in 100-mm VAS']","[{'cui': 'C0459705', 'cui_str': 'Fifth metatarsal structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332758', 'cui_str': 'Avulsion fracture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0426901', 'cui_str': 'Short leg'}, {'cui': 'C0179686', 'cui_str': 'Cast'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",145.0,0.177294,"The proportion of patients who reported satisfaction with their treatment was similar between the hard-soled shoe and cast groups (89.5% compared with 87.5%, respectively; p = 0.79), but the time to return to preinjury activity was significantly shorter in the hard-soled shoe group (37.2 ± 14.4 days compared with 43.0 ± 11.1 days in the cast group; p = 0.04).","[{'ForeName': 'Young Rak', 'Initials': 'YR', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Bom Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Inha University Hospital, Incheon, Republic of Korea.'}, {'ForeName': 'Yu Mi', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Sanbon Hospital, Wonkwang University College of Medicine, Gunpo, Republic of Korea.'}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Hallym Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea.'}, {'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Orthopedic Surgery, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Shinseok', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyong Nyun', 'Initials': 'HN', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Republic of Korea.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.20.00777']
2871,33252549,"Risk Factors for Increased Consumption of Narcotics After Hip Arthroscopy: A Prospective, Randomized Control Trial.","INTRODUCTION
No accepted standard exists regarding the number of opioids to prescribe after many surgical procedures, and previous literature has indicated that the number of opioids prescribed influences the total number of pills consumed. The goal of this study was to investigate whether prescribing less opioids after hip arthroscopy results in less total postoperative utilization without compromising analgesia and identify risk factors for increased use.
METHODS
This study randomized 111 patients to receive either 30 or 60 tablets of hydrocodone/acetaminophen 10 to 325 mg after hip arthroscopy. Demographic information, pain instruments, and scores including International Hip Outcome Tool (iHOT-12) were collected preoperatively. Postoperatively, patients were contacted over the course of 3 weeks to determine their Numeric Pain Rating Scale scores, total number of tablets taken/leftover, and the last day that they required narcotic pain medications, which were calculated and compared for each group. Preoperative variables that increased the risk of higher narcotic pain medication requirements were assessed.
RESULTS
Patients in the 60-tablet group had significantly more tablets leftover than the 30-tablet group (49.5 versus 22.0, P < 0.001) and had no significant difference in Numeric Pain Rating Scale scores at 24 hours, 48 hours, or final follow-up. The 30- and 60-tablet groups demonstrated no significant difference in average tablets consumed (9.2 and 10.5, P = 0.60), respectively. Risk factors for increased postoperative opioid use included preoperative opioid use (B = 12.62, 95% confidence interval [CI], 6.28-18.96, P < 0.001) or muscle relaxant use (B = 22.45, 95% CI, 7.59-37.31, P < 0.0036) within 1 year preoperatively. Preoperative iHOT-12 scoring also significantly predicted postoperative opioid consumption in this cohort (B = -0.25, 95% CI, -0.45 to -0.036, P < 0.022).
CONCLUSION
The number of leftover tablets after hip arthroscopy can be significantly reduced by prescribing 30 tablets compared with 60 tablets without affecting postoperative pain control. Total tablets prescribed in this cohort did not affect total opioid utilization. Preoperative factors including opioid or muscle relaxant use and iHOT-12 scores can be used to predict postoperative opioid requirements.",2020,"Risk factors for increased postoperative opioid use included preoperative opioid use (B = 12.62, 95% confidence interval [CI], 6.28-18.96, P < 0.001) or muscle relaxant use (B = 22.45, 95% CI, 7.59-37.31, P < 0.0036) within 1 year preoperatively.","['111 patients to receive either 30 or 60 tablets of', 'After Hip Arthroscopy']","['Narcotics', 'hydrocodone/acetaminophen']","['total opioid utilization', 'postoperative pain control', 'Demographic information, pain instruments, and scores including International Hip Outcome Tool (iHOT-12', 'postoperative opioid consumption', 'number of leftover tablets', 'narcotic pain medication requirements', 'Numeric Pain Rating Scale scores', 'tablets leftover', 'Numeric Pain Rating Scale scores, total number of tablets taken/leftover, and the last day that they required narcotic pain medications', 'average tablets']","[{'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}]","[{'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0717367', 'cui_str': 'Acetaminophen- and hydrocodone-containing product'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",111.0,0.0821039,"Risk factors for increased postoperative opioid use included preoperative opioid use (B = 12.62, 95% confidence interval [CI], 6.28-18.96, P < 0.001) or muscle relaxant use (B = 22.45, 95% CI, 7.59-37.31, P < 0.0036) within 1 year preoperatively.","[{'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Selley', 'Affiliation': 'From the Department of Orthopedic Surgery, Northwestern Memorial Hospital, Chicago, IL.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hartwell', 'Affiliation': ''}, {'ForeName': 'Bejan A', 'Initials': 'BA', 'LastName': 'Alvandi', 'Affiliation': ''}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Terry', 'Affiliation': ''}, {'ForeName': 'Vehniah K', 'Initials': 'VK', 'LastName': 'Tjong', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-20-00122']
2872,33252490,Losartan to reduce inflammation and fibrosis endpoints in HIV disease (LIFE-HIV): results from a randomized placebo-controlled trial.,"BACKGROUND
Persistent inflammation and incomplete immune recovery among persons with HIV are associated with increased disease risk. We hypothesized that the angiotensin receptor blocker (ARB) losartan would reduce inflammation by mitigating NFκB responses and promote T-cell recovery via inhibition of TGFβ mediated fibrosis.
METHODS
Losartan (100 mg) versus placebo over 12 months was investigated in a randomized (1:1) placebo-controlled trial, among persons with HIV (PHIV) age ≥50 years, receiving ART, with HIV RNA <200 copies/mL and CD4+ count ≤600 cells/μL. Inflammation, fibrosis, and myocardial biomarkers were measured in blood using ELISA, electrochemiluminescence, and immunoturbidimetric methods, and T-cell and monocyte phenotypes were assessed with flow cytometry among a subset of participants. Changes over follow-up in (log-2 transformed) biomarkers and cell phenotypes (untransformed) were compared between losartan and placebo arms using linear mixed models.
RESULTS
Among 108 PHIV (n = 52 to losartan; n = 56 to placebo), 97% had a month 12 visit. Median age was 57 years and baseline CD4+ count was 408 cells/mm. Losartan treatment was not associated with an improvement in IL-6 levels, or other blood measures of inflammation, immune activation, fibrosis activity, or myocardial function. CD4+ and CD8+ T-cells also did not differ by treatment group. Losartan reduced systolic and diastolic blood pressure by 6 and 5mmHg, respectively.
CONCLUSIONS
Among older PHIV with viral suppression, losartan did not improve blood measures of inflammation nor T-cell immune recovery. Losartan treatment is unlikely to reduce inflammation associated co-morbidities to a clinically meaningful degree, beyond the benefits from lowering blood pressure. CLINICALTRIALS.GOV:: NCT02049307.",2020,"Losartan treatment was not associated with an improvement in IL-6 levels, or other blood measures of inflammation, immune activation, fibrosis activity, or myocardial function.","['HIV disease (LIFE-HIV', 'Median age was 57 years and baseline CD4+ count was 408\u200acells/mm', 'persons with HIV', 'persons with HIV (PHIV) age ≥50 years, receiving ART, with HIV RNA <200\u200acopies/mL and CD4+ count ≤600\u200acells/μL. Inflammation, fibrosis, and myocardial biomarkers']","['angiotensin receptor blocker (ARB) losartan', 'placebo', 'Losartan', 'losartan', 'losartan and placebo']","['systolic and diastolic blood pressure', 'blood measures of inflammation nor T-cell immune recovery', 'CD4+ and CD8+ T-cells', 'IL-6 levels, or other blood measures of inflammation, immune activation, fibrosis activity, or myocardial function']","[{'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.344603,"Losartan treatment was not associated with an improvement in IL-6 levels, or other blood measures of inflammation, immune activation, fibrosis activity, or myocardial function.","[{'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Baker', 'Affiliation': 'Hennepin Healthcare Research Institute, Minneapolis, MN, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wolfson', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Collins', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Caryn', 'Initials': 'C', 'LastName': 'Morse', 'Affiliation': 'Wake Forest Baptist Medical Center, Winston Salem, NC, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Rhame', 'Affiliation': 'Allina Health, Minneapolis, MN, USA.'}, {'ForeName': 'Angelike P', 'Initials': 'AP', 'LastName': 'Liappis', 'Affiliation': 'Washington VA Medical Center, Washington DC, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Rizza', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Zelalem', 'Initials': 'Z', 'LastName': 'Temesgen', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Mystakelis', 'Affiliation': 'NIAID/ NIH, Bethesda, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Deeks', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Neaton', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Schacker', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Irini', 'Initials': 'I', 'LastName': 'Sereti', 'Affiliation': 'NIAID/ NIH, Bethesda, USA.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Tracy', 'Affiliation': 'University of Vermont, Burlington, VT, USA.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002773']
2873,33252489,Depressive symptoms and use of HIV care and medication-assisted treatment among people living with HIV who inject drugs.,"OBJECTIVE
Vietnam, Indonesia, and Ukraine have major burdens of injection drug use (IDU) and HIV. We estimated prevalence of depressive symptoms at baseline among people living with HIV (PLWH) who inject drugs, evaluated associations between depression at baseline and 12-month HIV care outcomes and medication-assisted treatment (MAT), and evaluated the study intervention effect by baseline depression subgroups.
DESIGN
HPTN 074 was a randomized study. The study intervention included psychosocial counseling, systems navigation, and antiretroviral treatment (ART) at any CD4 count.
METHODS
Moderate-to-severe depression was defined as a Patient Health Questionnaire (PHQ-9) score of 10 or above. ART and MAT were self-reported. Eligibility criteria were: 18-60 years of age, active IDU, and viral load ≥1000 cp/mL. Adjusted probability differences (aPD) were estimated using inverse-probability weighting.
RESULTS
502 participants enrolled from April 2015-June 2016. Median age was 35 years; 85% identified as men. Prevalence of baseline moderate-to-severe depression was 14% in Vietnam, 14% in Indonesia, and 56% in Ukraine. No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up. The study intervention improved the proportions of PWID achieving 12-month viral suppression in both the depressed (intervention 44%; standard of care (SOC) 24%; estimated aPD = 25% [95%CI: 4.0%, 45%]) and non-depressed subgroups (intervention 38%; SOC 24%; aPD = 13% [95%CI: 2.0%, 25%]).
CONCLUSIONS
High levels of depressive symptoms were common among PLWH who inject drugs in Ukraine but were less common in Vietnam and Indonesia. The study intervention was effective among participants with or without baseline depression symptoms.",2020,"No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up.","['people living with HIV (PLWH) who inject drugs, evaluated associations between depression at baseline and 12-month HIV care outcomes and medication-assisted treatment (MAT), and evaluated the study intervention effect by baseline depression subgroups', 'participants with or without baseline depression symptoms', 'Median age was 35 years; 85% identified as men', 'Moderate-to-severe depression was defined as a Patient Health Questionnaire (PHQ-9) score of 10 or above', '502 participants enrolled from April 2015-June 2016', 'people living with HIV who inject drugs']","['psychosocial counseling, systems navigation, and antiretroviral treatment (ART) at any CD4 count', 'HIV care and medication-assisted treatment']","['Depressive symptoms', 'proportions of PWID achieving 12-month viral suppression', 'baseline depression and ART, viral suppression, or MAT', 'depressive symptoms', 'Prevalence of baseline moderate-to-severe depression']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0165079', 'cui_str': 'IS 35'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0841579', 'cui_str': 'Psychosocial counseling'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]",502.0,0.166131,"No evident associations were detected between baseline depression and ART, viral suppression, or MAT at 12-month follow-up.","[{'ForeName': 'Oleksandr', 'Initials': 'O', 'LastName': 'Zeziulin', 'Affiliation': 'Ukrainian Institute on Public Health Policy.'}, {'ForeName': 'Katie R', 'Initials': 'KR', 'LastName': 'Mollan', 'Affiliation': 'School of Medicine, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Bonnie E', 'Initials': 'BE', 'LastName': 'Shook-Sa', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Hanscom', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Research Center.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Lancaster', 'Affiliation': 'College of Public Health, The Ohio State University.'}, {'ForeName': 'Kostyantyn', 'Initials': 'K', 'LastName': 'Dumchev', 'Affiliation': 'Ukrainian Institute on Public Health Policy.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Viet A', 'Initials': 'VA', 'LastName': 'Chu', 'Affiliation': 'UNC Vietnam, Vietnam.'}, {'ForeName': 'Tetiana', 'Initials': 'T', 'LastName': 'Kiriazova', 'Affiliation': 'Ukrainian Institute on Public Health Policy.'}, {'ForeName': 'Zulvia', 'Initials': 'Z', 'LastName': 'Syarif', 'Affiliation': 'Abhipraya Foundation & Department Psychiatry Faculty of Medicine, University of Indonesia.'}, {'ForeName': 'Sergii', 'Initials': 'S', 'LastName': 'Dvoryaka', 'Affiliation': ''}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Reifeis', 'Affiliation': 'Gillings School of Global Public Health, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Hamilton', 'Affiliation': 'Family Health International (FHI 360).'}, {'ForeName': 'Riza', 'Initials': 'R', 'LastName': 'Sarasvita', 'Affiliation': 'Indonesia National Narcotics Board & Abhipraya Foundation.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Family Health International (FHI 360).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'Johns Hopkins University.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Clarke', 'Affiliation': 'Johns Hopkins University.'}, {'ForeName': 'Carl A', 'Initials': 'CA', 'LastName': 'Latkin', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Metzger', 'Affiliation': 'University of Pennsylvania.'}, {'ForeName': 'Irving F', 'Initials': 'IF', 'LastName': 'Hoffman', 'Affiliation': 'School of Medicine, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Miller', 'Affiliation': 'College of Public Health, The Ohio State University.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002774']
2874,33252482,Optimizing respondent driven sampling to find undiagnosed HIV-infected people who inject drugs.,"OBJECTIVE
We evaluated whether identification of undiagnosed HIV-infected people who inject drugs (PWID) via respondent-driven sampling (RDS) can be enhanced through a precision RDS (pRDS) approach.
DESIGN/METHODS
First, using prior RDS data from PWID in India, we built a prediction algorithm for recruiting undiagnosed HIV-infected PWID. pRDS was tested in Morinda, Punjab where participants were randomly assigned to standard or pRDS. In the standard RDS approach, all participants received 2 recruitment coupons. For pRDS, the algorithm determined an individual's probability of recruiting an undiagnosed PWID, and individuals received either 2 (low probability) or 5 (high probability) coupons. Efficiency in identifying undiagnosed HIV-infected PWID for the RDS approaches was evaluated in two ways: the number needed to recruit (NNR) and identification rate/week.
RESULTS
Predictors of recruiting undiagnosed PWID included HIV/HCV infection, network size, syringe services utilization, and injection environment. 1631 PWID were recruited in Morinda. From the standard RDS approach, 615 were recruited, including 39 undiagnosed; from pRDS, 1012 were recruited, including 77 undiagnosed. In pRDS, those with higher predicted probability were more likely to recruit others with HIV/HCV co-infection, undiagnosed and viremic HIV, and who utilized services. pRDS had a significantly higher identification rate of undiagnosed PWID (1.5/week) compared to the standard (0.8/week). The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
CONCLUSIONS
pRDS identified twice as many undiagnosed and viremic PWID significantly faster than the standard approach. Leveraging RDS or similar network-based strategies should be considered alongside other strategies to ensure meeting UNAIDS targets.",2020,"The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
","['undiagnosed HIV-infected people who inject drugs', '1631 PWID were recruited in Morinda', '615 were recruited, including 39 undiagnosed; from pRDS, 1012 were recruited, including 77 undiagnosed', 'undiagnosed HIV-infected people who inject drugs (PWID) via respondent-driven sampling (RDS']","['standard or pRDS', 'pRDS']","['identification rate of undiagnosed PWID', 'HIV/HCV infection, network size, syringe services utilization, and injection environment']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1010821', 'cui_str': 'Morinda'}, {'cui': 'C5192273', 'cui_str': '615'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C4704820', 'cui_str': 'Services Utilization'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",1631.0,0.0633873,"The NNR for pRDS (13.1) was not significantly lower than the standard approach (15.8).
","[{'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'McFall', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Aylur K', 'Initials': 'AK', 'LastName': 'Srikrishnan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Canjeevaram K', 'Initials': 'CK', 'LastName': 'Vasudevan', 'Affiliation': 'YR Gaitonde Centre for AIDS Research and Education, Chennai, India.'}, {'ForeName': 'Shruti H', 'Initials': 'SH', 'LastName': 'Mehta', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Solomon', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002763']
2875,33252480,"Impact of rosuvastatin on atherosclerosis in people with HIV at moderate cardiovascular risk; a randomised, controlled trial.",": People living with HIV-1 (PLHIV) are at increased risk for cardiovascular disease.
OBJECTIVE
This study aimed to determine if PLHIV would benefit from starting statins at a lower threshold than currently recommended in the general population.
DESIGN
A double-blind multicentre, randomised, placebo-controlled trial was performed.
METHODS
Participants (n = 88) with well controlled HIV, at moderate cardiovascular risk (Framingham score of 10-15%), and not recommended for statins were recruited from Australia and Switzerland. They were randomised 1:1 to rosuvastatin (n = 44) 20 mg daily, 10 mg if co-administered with ritonavir/cobicistat-boosted antiretroviral therapy, or placebo (n = 40) for 96 weeks. Assessments including fasting blood collection and carotid intima media thickness (CIMT) were performed at baseline, and weeks 48 and 96. The primary outcome was the change from baseline to week 96 in CIMT. (clinicaltrials.gov:NCT01813357) RESULTS:: Participants were predominantly male (82 (97·6%)); mean age 54 years (SD 6·0). At 96 weeks there was no difference in the progression of CIMT between the rosuvastatin (mean 0·004 mm, SE 0·0036) and placebo (0·0062 mm, SE 0·0039) arms (p value = 0·684), leading to no difference in CIMT levels between groups at week 96 (rosuvastatin arm, 0·7232 mm (SE 0·030); placebo arm 0·7785 mm (SE 0·032), p = 0·075).Adverse events were common (n = 146) and predominantly in the rosuvastatin arm (108 [73·9%]). Participants on rosuvastatin were more likely to cease study medication due to an adverse event (7 [15.9%] vs 2 [5·0%], p = 0.011).
CONCLUSIONS
In PLHIV statins prescribed at a lower threshold than guidelines did not lead to improvements in CIMT but was associated with significant adverse events.",2020,"At 96 weeks there was no difference in the progression of CIMT between the rosuvastatin (mean 0·004 mm, SE 0·0036) and placebo (0·0062 mm, SE 0·0039) arms (p value = 0·684), leading to no difference in CIMT levels between groups at week 96 (rosuvastatin arm, 0·7232 mm (SE 0·030); placebo arm 0·7785 mm (SE 0·032), p = 0·075).Adverse events were common (n = 146) and predominantly in the rosuvastatin arm (108 [73·9%]).","['Participants were predominantly male (82 (97·6%)); mean age 54 years (SD 6·0', 'Participants (n\u200a=\u200a88) with well controlled HIV, at moderate cardiovascular risk (Framingham score of 10-15%), and not recommended for statins were recruited from Australia and Switzerland', 'people with HIV at moderate cardiovascular risk', ' People living with HIV-1 (PLHIV']","['rosuvastatin (n\u200a=\u200a44) 20\u200amg daily, 10\u200amg if co-administered with ritonavir/cobicistat-boosted antiretroviral therapy, or placebo', 'placebo', 'rosuvastatin']","['CIMT levels', 'adverse event', 'fasting blood collection and carotid intima media thickness (CIMT', 'progression of CIMT']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.684659,"At 96 weeks there was no difference in the progression of CIMT between the rosuvastatin (mean 0·004 mm, SE 0·0036) and placebo (0·0062 mm, SE 0·0039) arms (p value = 0·684), leading to no difference in CIMT levels between groups at week 96 (rosuvastatin arm, 0·7232 mm (SE 0·030); placebo arm 0·7785 mm (SE 0·032), p = 0·075).Adverse events were common (n = 146) and predominantly in the rosuvastatin arm (108 [73·9%]).","[{'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Trevillyan', 'Affiliation': 'Department of Infectious Diseases, Alfred Health and Monash University, Melbourne Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dart', 'Affiliation': 'Department of Cardiology, Alfred Health, Melbourne Australia.'}, {'ForeName': 'Eldho', 'Initials': 'E', 'LastName': 'Paul', 'Affiliation': 'Biostatistics Consulting Platform, Faculty of Medicine, Nursing and Health Sciences, Monash University, Commercial Rd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Cavassini', 'Affiliation': 'Division of Infectious Diseases, University Hospital Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Fehr', 'Affiliation': 'Department of Public & Global Health, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Staehelin', 'Affiliation': 'Inselspital, Bern, Switzerland.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Dewar', 'Affiliation': 'Department of Cardiology, Alfred Health, Melbourne Australia.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Hoy', 'Affiliation': 'Department of Infectious Diseases, Alfred Health and Monash University, Melbourne Australia.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Calmy', 'Affiliation': 'Division of Infectious Diseases, HIV/AIDS Unit, Geneva University Hospitals, Geneva, Switzerland.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002764']
2876,33252461,"Commentary on the Influence of Topical Anesthesia on Superficial Sensitivity: A Double Blind, Randomized, Placebo Controlled Study on 48 Healthy Subjects.",,2020,,['48 Healthy Subjects'],"['Topical Anesthesia', 'Placebo']",['Superficial Sensitivity'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0472473', 'cui_str': 'Topical local anesthetic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.299951,,"[{'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Green', 'Affiliation': 'Clinical Professor of Dermatology, George Washington University School of Medicine, Washington, District of Columbia.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002596']
2877,33252440,Prospective Randomized Trial on Smoking Cessation in Orthopaedic Trauma Patients: Results from the Let's STOP (Smoking in Trauma Orthopaedic Patients) Now Trial.,"OBJECTIVES
To determine if inpatient counseling with additional counseling could increase smoking cessation.
DESIGN
Prospective study.
SETTING
Level I trauma center.
PATIENTS/PARTICIPANTS
Current smokers with an operative fracture randomly assigned to control (no counseling), brief counseling (inpatient counseling), or intense counseling (brief counseling plus follow-up) groups.
INTERVENTION
Brief inpatient smoking counseling and referral to a nationally-based quitline.
MAIN OUTCOME MEASUREMENTS
Smoking cessation confirmed by exhaled carbon monoxide, recorded at 12 and 26 weeks.
RESULTS
Overall, 266 patients participated, with 40, 111, and 115 patients in the control and treatment groups, respectively. At 3 months, 17% of control versus 11% and 10% brief and intense counseling groups quit smoking, respectively. At 6 months, 15% of control, and 10% and 5% of the respective counseling groups quit. No significant difference reported between groups. Forty-three percent of patients accepted quitline referral. Intense counseling patients were 3 times more likely to accept referral (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.4-6.9) and brief counseling patients were more than 2 times as likely to accept referral (OR, 2.3; 95% CI, 1.0-5.1). Overall, 54% of participants who accepted the quitline referral accepted quitline services. Intense counseling (OR, 8.2; 95% CI, 1.0-68.5) and brief counseling (OR, 5.3; 95% CI, 0.6-44.9) patients were more likely to use quitline services.
CONCLUSION
Increasing levels of inpatient counseling can improve successful referral to quitline, but it does not appear to influence quit rates amongst orthopaedic trauma patients.
LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Intense counseling patients were 3 times more likely to accept referral (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.4-6.9) and brief counseling patients were more than 2 times as likely to accept referral (OR, 2.3; 95% CI, 1.0-5.1).","['Orthopaedic Trauma Patients', '266 patients participated, with 40, 111, and 115 patients in the control and treatment groups, respectively', 'Level', 'Current smokers with an operative fracture randomly assigned to', 'Trauma Orthopaedic Patients']","['Brief inpatient smoking counseling and referral to a nationally-based quitline', 'control (no counseling), brief counseling (inpatient counseling), or intense counseling (brief counseling plus follow-up) groups', 'Smoking Cessation']","['accept referral', 'Smoking cessation confirmed by exhaled carbon monoxide']","[{'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1273715', 'cui_str': 'Advice on smoking'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",266.0,0.0543618,"Intense counseling patients were 3 times more likely to accept referral (odds ratio [OR], 3.1; 95% confidence interval [CI], 1.4-6.9) and brief counseling patients were more than 2 times as likely to accept referral (OR, 2.3; 95% CI, 1.0-5.1).","[{'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Matuszewski', 'Affiliation': 'Department of Orthopaedic Surgery and Sports Medicine, University of Kentucky School of Medicine, Lexington, KY.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Joseph', 'Affiliation': 'American Trauma Society, Falls Church, VA.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'DiClemente', 'Affiliation': 'University of Maryland Baltimore County, University of Maryland, Baltimore, MD.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000002028']
2878,33252432,Preconsultation Educational Group Intervention Can Address the Knowledge Gap in Postmastectomy Breast Reconstruction.,"BACKGROUND
Whether to undergo postmastectomy breast reconstruction (PMBR) is a challenging, preference-sensitive decision. It is therefore paramount to optimize decision quality through ensuring patients' knowledge and aligning treatments with their personal preferences. This study assessed the effects of a preconsultation educational group intervention (PEGI) on patient knowledge, state-trait anxiety, and decisional conflict (patient uncertainty in decision making) during the decision-making process.
METHODS
This phase 3 randomized controlled trial assessed effects of a PEGI in women without active breast cancer undergoing delayed PMBR, or prophylactic mastectomy with immediate PMBR. Both groups underwent routine education before consultation. In addition, the intervention group underwent a PEGI composed of presentations from a plastic surgeon and nurse, a value clarification exercise, and shared experiences from PMBR patients before the consultation with the plastic surgeon. Before and 1-week after consultation, outcome measures were assessed using the Decisional Conflict Scale, State-Trait Anxiety Inventory, and the BREAST-Q.
RESULTS
Of the 219 women deemed eligible, a total of 156 women were recruited and randomized. Treatment fidelity was 96% and retention was 88%. At baseline, there were no significant differences in terms of demographic or clinical status, knowledge, state-trait anxiety, and decisional conflict. Patient knowledge about PMBR improved in both groups; however, the degree of knowledge attainment was significantly greater in the PEGI group (24.5% improvement in the intervention group compared with 13.5% in the routine education group, P < 0.001). The reduction in decisional conflict from baseline to follow-up was greater in the intervention group compared with the routine education; however, the difference only approached significance (P = 0.09).
CONCLUSIONS
The provision of a preconsultation educational group intervention has been shown to significantly close the knowledge gap on PMBR in patients seeking delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction compared with routine education alone.",2020,"The reduction in decisional conflict from baseline to follow-up was greater in the intervention group compared with the routine education; however, the difference only approached significance (P = 0.09).
","['women without active breast cancer undergoing delayed PMBR, or prophylactic mastectomy with immediate PMBR', '219 women deemed eligible, a total of 156 women']","['PEGI', 'postmastectomy breast reconstruction (PMBR', 'preconsultation educational group intervention', 'preconsultation educational group intervention (PEGI']","['degree of knowledge attainment', 'Treatment fidelity', 'demographic or clinical status, knowledge, state-trait anxiety, and decisional conflict', 'Decisional Conflict Scale, State-Trait Anxiety Inventory, and the BREAST-Q', 'patient knowledge, state-trait anxiety, and decisional conflict', 'Patient knowledge about PMBR', 'decisional conflict']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C2191320', 'cui_str': 'Prophylactic mastectomy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]",156.0,0.0415949,"The reduction in decisional conflict from baseline to follow-up was greater in the intervention group compared with the routine education; however, the difference only approached significance (P = 0.09).
","[{'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Zhong', 'Affiliation': 'From the aDivision of Plastic Surgery, Department of Surgery and Surgical Oncology, University Health Network bDivision of Plastic and Reconstructive Surgery, Department of Surgery, University of Toronto cSocial Work, Cancer Survivorship Program, Princess Margaret Hospital, University Health Network dDepartment of Surgery, Division of General Surgery, Faculty of Nursing; and Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada. eLawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Whitney L', 'Initials': 'WL', 'LastName': 'Quong', 'Affiliation': ''}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Kerrebijn', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Butler', 'Affiliation': ''}, {'ForeName': 'Stefan O P', 'Initials': 'SOP', 'LastName': 'Hofer', 'Affiliation': ''}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'OʼNeill', 'Affiliation': ''}, {'ForeName': 'Tulin D', 'Initials': 'TD', 'LastName': 'Cil', 'Affiliation': ''}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Metcalfe', 'Affiliation': ''}]",Annals of plastic surgery,['10.1097/SAP.0000000000002603']
2879,33252406,A Motivational Interviewing Intervention to Promote CRC Screening: A Pilot Study.,"BACKGROUND
Appalachian Kentuckians suffer a disproportionate incidence and mortality from colorectal cancer (CRC) and are screened at lower rates (35%) compared with 47% of Kentuckians.
OBJECTIVE
The aim of this study was to evaluate the efficacy of a motivational interviewing intervention delivered by trained Lay Health Advisors on CRC screening.
METHOD
Eligible participants recruited from an emergency department (ED) completed a baseline survey and were randomized to either the control or the motivational interviewing intervention provided by Lay Health Advisors. Follow-up surveys were administered 3 and 6 months after baseline. To evaluate potential differences in treatment and control groups, t tests, χ, and Mann-Whitney U tests were used.
RESULTS
At either the 3- or 6-month assessment, there was no difference in the CRC screening by group (χ = 0.13, P = .72). There was a significant main effect for the study group in the susceptibility to CRC model; regardless of time, those in the intervention group reported approximately 1-point higher perceived susceptibility to CRC, compared with controls (est. b = 0.68, P = .038). Age and financial adequacy had a significant effect related to CRC screening. Older participants (est. b = 0.09, P = .014) and those who reported financial inadequacy (est. b = 2.34, P = .002) reported more screening barriers.
CONCLUSION
This pilot study elucidated important factors influencing the uptake of CRC for an ED transient population and this may be useful in the design of future interventions using motivational interviewing in EDs.
IMPLICATIONS FOR PRACTICE
Nurses can provide information about CRC screening guidelines and provide referrals to appropriate screening resources in the community.",2020,"At either the 3- or 6-month assessment, there was no difference in the CRC screening by group (χ = 0.13, P = .72).","['Eligible participants recruited from an emergency department (ED) completed a baseline survey', 'Older participants (est']","['motivational interviewing intervention', 'motivational interviewing intervention provided by Lay Health Advisors', 'Motivational Interviewing Intervention']","['CRC screening', 'susceptibility to CRC', 'screening barriers']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0364421,"At either the 3- or 6-month assessment, there was no difference in the CRC screening by group (χ = 0.13, P = .72).","[{'ForeName': 'Adebola', 'Initials': 'A', 'LastName': 'Adegboyega', 'Affiliation': 'Author Affiliations: University of Kentucky College of Nursing, Lexington (Drs Adegboyega and Wiggins); University of Louisville School of Nursing, Kentucky (Dr Aleshire); and University of Arizona Mel and Enid Zuckerman College of Public Health, Phoenix (Ms Palmer and Dr Hatcher).'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Aleshire', 'Affiliation': ''}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Wiggins', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Palmer', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hatcher', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000905']
2880,33252169,Edmonton Symptom Assessment Scale time duration of self-completion versus assisted-completion in advanced cancer patients: a randomized comparison.,"INTRODUCTION
To compare the time duration of self-completion (SC) of the Edmonton Symptom Assessment Scale (ESAS) by advanced cancer patients (ACP) vs. assisted-completion (AC) with a health care professional (HCP).
METHODS
In this randomized comparison of ACP seen in initial consultation at the outpatient Supportive Care Center at MD Anderson, ACP who have never completed the ESAS at MD Anderson were allocated (1:1) to either SC of the ESAS form vs AC by a nurse. Time of completion was measured by the nurse using a stopwatch. Patients completed the Rapid Estimate of Adult Literacy in Medicine (REALM) test prior to administration of the ESAS. In the SC group, the nurse reviewed the responses to verify that the reported ESAS scores were correct.
RESULTS
126 ACP were enrolled (69 patients to AC and 57 to SC). 71 patients were female, median age was 60 years old, and median REALM score was 65. Median (IQR) time (seconds) of SC was significantly less than AC (73 (42.9, 89.1) vs 109 (79.5, 136.7), p<.0001). With nurse review time included, median time of SC increased to 117 seconds, which was not significantly different from AC (p=.28). Lower literacy (REALM) score and shortness of breath were significantly associated with increased completion time (p=.007).
CONCLUSION
Regular use of ESAS will have minimal impact on clinical time as it can be completed in about one minute and provides a concise yet comprehensive and multidimensional perspective of symptoms that affect cancer patients' quality of life.
IMPLICATIONS FOR PRACTICE
Since the Edmonton Symptom Assessment Scale can be completed in less than 2 minutes, hopefully the routine use of this simple yet comprehensive and multidimensional symptom assessment tool will be used at all medical visits in all cancer patients so that the timely management of symptoms affecting cancer patients' lives and treatment courses can occur, further enhancing personalized cancer care.",2020,"Lower literacy (REALM) score and shortness of breath were significantly associated with increased completion time (p=.007).
","['71 patients were female, median age was 60\u2009years old, and median REALM score was 65', 'advanced cancer patients', 'initial consultation at the outpatient Supportive Care Center at MD Anderson, ACP who have never completed the ESAS at MD Anderson', 'advanced cancer patients (ACP) vs', '126 ACP were enrolled (69 patients to AC and 57 to SC']","['assisted-completion (AC) with a health care professional (HCP', 'ESAS', 'ACP']","['median time of SC', 'Median (IQR) time (seconds) of SC', 'ESAS scores', 'Lower literacy (REALM) score and shortness of breath', 'time duration of self-completion (SC) of the Edmonton Symptom Assessment Scale (ESAS', 'Time of completion', 'Edmonton Symptom Assessment Scale time duration of self-completion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",126.0,0.055223,"Lower literacy (REALM) score and shortness of breath were significantly associated with increased completion time (p=.007).
","[{'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Supakarn', 'Initials': 'S', 'LastName': 'Tayjasanant', 'Affiliation': 'Siriraj Palliative Care Center, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Rodriguez-Nunez', 'Affiliation': 'Palliative Care and Continuing Care Program, Faculty of Medicine, Pontificia Universidad Catolica de Chile, Santiago, Chile.'}, {'ForeName': 'Minjeong', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kresnier Perez', 'Initials': 'KP', 'LastName': 'Zapata', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Allo', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Frisbee-Hume', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center.'}]",The oncologist,['10.1002/onco.13619']
2881,33252118,Analgesic effects of piritramide in acute postoperative pain - comparison of intramuscular administration with patient-controlled intravenous analgesia and impact of OPRM1 and ABCB1 polymorphisms.,"AIMS
The aim of this study was to compare the efficacy, consumption and safety after piritramide administered either intramuscularly (IM) on demand or via patient-controlled intravenous analgesia (PCA) and to examine the impact of OPRM1 and ABCB1 gene polymorphisms on the drug efficacy/safety in both regimens.
METHODS
One hundred and four patients scheduled for elective inguinal hernioplasty received piritramide with PCA or IM for postoperative pain management. We evaluated piritramide consumption, pain intensity using visual analogue scale (VAS) and adverse effects.
RESULTS
Median (IQR) piritramide consumption was 18.5 (13.5-31.2) and 15.0 (15.0-15.0) mg in the PCA and IM groups, respectively (P=0.0092). The respective values of area under the VAS 2-16 -time curve were 40 and 280 mm.h (P=0.0027). Opioid-induced adverse effects were more frequent in the PCA than in the IM group. Variant OPRM1 allele was associated with decreased pain relief, increased opioid consumption and increased incidence of adverse effects, while ABCB1 polymorphisms showed no impact on the observed parameters.
CONCLUSIONS
We observed higher piritramide consumption, better pain relief and slightly worse safety profile in the PCA group compared with IM administration. Variant OPRM1 118G allele carriers required higher opioid dosing and suffered from more adverse effects, however, the differences between genotypes have been less pronounced in the PCA patients likely due to improved pain management via PCA.",2020,"We observed higher piritramide consumption, better pain relief and slightly worse safety profile in the PCA group compared with IM administration.","['One hundred and four patients scheduled for elective inguinal hernioplasty received', 'acute postoperative pain - comparison of intramuscular administration with patient-controlled intravenous analgesia and impact of OPRM1 and ABCB1 polymorphisms']","['piritramide', 'piritramide with PCA or IM']","['pain relief', 'Variant OPRM1', 'Analgesic effects', 'Median (IQR) piritramide consumption', 'pain relief, increased opioid consumption', 'piritramide consumption, pain intensity using visual analogue scale (VAS) and adverse effects', 'adverse effects', 'efficacy, consumption and safety', 'respective values of area under the VAS 2-16 -time curve']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0031982', 'cui_str': 'Pirinitramide'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0031982', 'cui_str': 'Pirinitramide'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",104.0,0.170306,"We observed higher piritramide consumption, better pain relief and slightly worse safety profile in the PCA group compared with IM administration.","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Bartosova', 'Affiliation': 'Department of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sima', 'Affiliation': 'Department of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Polanecky', 'Affiliation': 'Third Department of Surgery, First Faculty of Medicine, Charles University in Prague and Motol University Hospital, V Uvalu 84, 150 06 Prague 5, Czech Republic.'}, {'ForeName': 'Frantisek', 'Initials': 'F', 'LastName': 'Perlik', 'Affiliation': 'Department of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic.'}, {'ForeName': 'Svatopluk', 'Initials': 'S', 'LastName': 'Adamek', 'Affiliation': 'Third Department of Surgery, First Faculty of Medicine, Charles University in Prague and Motol University Hospital, V Uvalu 84, 150 06 Prague 5, Czech Republic.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lischke', 'Affiliation': 'Third Department of Surgery, First Faculty of Medicine, Charles University in Prague and Motol University Hospital, V Uvalu 84, 150 06 Prague 5, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Slanar', 'Affiliation': 'Department of Pharmacology, First Faculty of Medicine, Charles University and General University Hospital in Prague, Albertov 4, 128 00 Prague 2, Czech Republic.'}]","Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia",['10.5507/bp.2020.053']
2882,33252102,Functional outcomes of botulinum neurotoxin-A injection followed by reciprocal electrical stimulation in children with cerebral palsy: A randomized controlled trial.,"BACKGROUND
The integration of therapeutic approaches is increasingly recommended for children with cerebral palsy, to enhance outcomes. Nevertheless, clinicians still opt for separate or combined therapies based on little credible knowledge.
OBJECTIVE
This study endeavored to evaluate the effect of botulinum neurotoxin-A (BoNT-A) injection and reciprocal neuromuscular electrical stimulation (rNMES) and their combination on the upper extremity function in children with spastic hemiplegia.
METHODS
Sixty-four children with spastic hemiplegia (aged 6- 10 years) were randomly assigned to four treatment-based groups [group I (BoNT-A), group II (rNMES), group III (combined BoNT-A and rNMES), and group IV (Control)]. All children received a physical rehabilitation program, thrice/week over three months. Unilateral upper-limb function, bimanual hand function, and real-time arm-hand function were assessed using Melbourne Assessment (MA), Assisting Hand Assessment (AHA), and Pediatric Motor Activity Log (PMAL) scales respectively pre-treatment, post-treatment, and at 6 months follow-up.
RESULTS
Post-treatment, group III achieved greater improvement in MA, AHA, and PMAL compared to other groups (all P < 0.05), and the difference remained in favor of group III at the follow-up (all P < 0.05).
CONCLUSIONS
This study suggests that BoNT-A and rNMES combined are more effective than either of them alone to enhance upper-extremity function in children with spastic hemiplegia.",2020,"RESULTS
Post-treatment, group III achieved greater improvement in MA, AHA, and PMAL compared to other groups (all P < 0.05), and the difference remained in favor of group III at the follow-up (all P < 0.05).
","['children with spastic hemiplegia', 'Sixty-four children with spastic hemiplegia (aged 6- 10 years', 'children with cerebral palsy']","['reciprocal electrical stimulation', 'group II (rNMES), group III (combined BoNT-A and rNMES', 'botulinum neurotoxin', 'physical rehabilitation program', 'botulinum neurotoxin-A (BoNT-A) injection and reciprocal neuromuscular electrical stimulation (rNMES']","['Melbourne Assessment (MA), Assisting Hand Assessment (AHA), and Pediatric Motor Activity Log (PMAL) scales', 'MA, AHA, and PMAL', 'Unilateral upper-limb function, bimanual hand function, and real-time arm-hand function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0154694', 'cui_str': 'Spastic hemiplegia'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C1295507', 'cui_str': 'Bontoxilysin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0050451', 'cui_str': 'acetohydroxamic acid'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",64.0,0.0324957,"RESULTS
Post-treatment, group III achieved greater improvement in MA, AHA, and PMAL compared to other groups (all P < 0.05), and the difference remained in favor of group III at the follow-up (all P < 0.05).
","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Bader A', 'Initials': 'BA', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Mohammed F', 'Initials': 'MF', 'LastName': 'Elbanna', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}]",Restorative neurology and neuroscience,['10.3233/RNN-201088']
2883,33252090,Effects and Acceptability of an Individualized Home-Based 10-Week Training Program in Adults with Myotonic Dystrophy Type 1.,"BACKGROUND
Muscle weakness is a cardinal sign of myotonic dystrophy type 1, causing important functional mobility limitations and increasing the risk of falling. As a non-pharmacological, accessible and safe treatment for this population, strength training is an intervention of choice.
OBJECTIVE
To document the effects and acceptability of an individualized semi-supervised home-based exercise program on functional mobility, balance and lower limb strength, and to determine if an assistive training device has a significant impact on outcomes.
METHODS
This study used a pre-post test design and men with the adult form of DM1 were randomly assigned to the control or device group. The training program was performed three times a week for 10 weeks and included three exercises (sit-to-stand, squat, and alternated lunges). Outcome measures included maximal isometric muscle strength, 10-Meter Walk Test, Mini-BESTest, 30-Second Chair Stand test and 6-minute walk test.
RESULTS
No outcome measures showed a significant difference, except for the knee flexor muscles between the two assessments. All participants improved beyond the standard error of measurement in at least two outcome measures. The program and the device were well accepted and all participants reported many perceived improvements at the end of the program.
CONCLUSIONS
Our results provide encouraging data on the effects and acceptability of a home-based training program for men with the adult form of DM1. These programs would reduce the financial burden on the health system while improving the clinical services offered to this population.",2020,"No outcome measures showed a significant difference, except for the knee flexor muscles between the two assessments.","['men with the adult form of DM1', 'Adults with Myotonic Dystrophy Type 1']","['individualized semi-supervised home-based exercise program', 'Individualized Home-Based 10-Week Training Program']","['functional mobility, balance and lower limb strength', 'knee flexor muscles', 'maximal isometric muscle strength, 10-Meter Walk Test, Mini-BESTest, 30-Second Chair Stand test and 6-minute walk test']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]",,0.0395057,"No outcome measures showed a significant difference, except for the knee flexor muscles between the two assessments.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lessard', 'Affiliation': 'Département des sciences de la santé, physiothérapie, Université du Québec à Chicoutimi, Québec, Canada.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Gaboury', 'Affiliation': ""Laboratoire d'Intelligence Ambiante pour la Reconnaissance d'Activités (LIARA), Université du Québec à Chicoutimi, Québec, Canada.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Gagnon', 'Affiliation': 'Groupe de recherche interdisciplinaire sur les maladies neuromusculaires (GRIMN), Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean, Québec, Canada.'}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Bouchard', 'Affiliation': ""Laboratoire d'Intelligence Ambiante pour la Reconnaissance d'Activités (LIARA), Université du Québec à Chicoutimi, Québec, Canada.""}, {'ForeName': 'Kévin', 'Initials': 'K', 'LastName': 'Chapron', 'Affiliation': ""Laboratoire d'Intelligence Ambiante pour la Reconnaissance d'Activités (LIARA), Université du Québec à Chicoutimi, Québec, Canada.""}, {'ForeName': 'Mélissa', 'Initials': 'M', 'LastName': 'Lavoie', 'Affiliation': 'Groupe de recherche interdisciplinaire sur les maladies neuromusculaires (GRIMN), Centre intégré universitaire de santé et de services sociaux du Saguenay-Lac-Saint-Jean, Québec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lapointe', 'Affiliation': ""Laboratoire d'Intelligence Ambiante pour la Reconnaissance d'Activités (LIARA), Université du Québec à Chicoutimi, Québec, Canada.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Duchesne', 'Affiliation': 'Département des sciences de la santé, physiothérapie, Université du Québec à Chicoutimi, Québec, Canada.'}]",Journal of neuromuscular diseases,['10.3233/JND-200570']
2884,33252075,Retinal Optical Coherence Tomography Metrics are Unchanged in Verubecestat Alzheimer's Disease Clinical Trial but Correlate with Baseline Regional Brain Atrophy.,"BACKGROUND
We performed exploratory analyses of retinal thickness data from a clinical trial of the AβPP cleaving enzyme (BACE) inhibitor verubecestat in patients with Alzheimer's disease (AD).
OBJECTIVE
To evaluate: 1) possible retinal thickness changes following BACE inhibition; and 2) possible association between retinal thickness and brain atrophy.
METHODS
Retinal thickness was measured using spectral-domain optical coherence tomography in a 78-week randomized placebo-controlled trial of verubecestat in 1,785 patients with mild-to-moderate AD. Changes from baseline in retinal pigment epithelium, macular grid retinal nerve fiber layer, central subfield retinal thickness, and macular grid volume were evaluated for verubecestat versus placebo. Correlation analyses were performed to investigate the potential association between macular grid retinal nerve fiber layer and central subfield retinal thickness with brain volumetric magnetic resonance imaging (vMRI) data at baseline, as well as correlations for changes from baseline at Week 78 in patients receiving placebo.
RESULTS
Verubecestat did not significantly alter retinal thickness during the trial compared with placebo. At baseline, mean macular grid retinal nerve fiber layer and central subfield retinal thickness were weakly but significantly correlated (Pearson's r values≤0.23, p-values < 0.01) with vMRI of several brain regions including whole brain, hippocampus, and thalamus. At Week 78, correlations between retinal thickness and brain vMRI changes from baseline in the placebo group were small and mostly not statistically significant.
CONCLUSION
BACE inhibition by verubecestat was not associated with adverse effects on retinal thickness in patients with mild-to-moderate AD. Correlations between retinal thickness and brain volume were observed at baseline.
TRIAL REGISTRATION
Clinicaltrials.gov NCT01739348 (registered December 3, 2012; https://clinicaltrials.gov/ct2/show/NCT01739348).",2020,BACE inhibition by verubecestat was not associated with adverse effects on retinal thickness in patients with mild-to-moderate AD.,"[""patients with Alzheimer's disease (AD"", '1,785 patients with mild-to-moderate AD', 'patients with mild-to-moderate AD']","['AβPP cleaving enzyme (BACE) inhibitor verubecestat', 'spectral-domain optical coherence tomography', 'placebo']","['retinal thickness and brain vMRI changes', 'retinal pigment epithelium, macular grid retinal nerve fiber layer, central subfield retinal thickness, and macular grid volume', 'mean macular grid retinal nerve fiber layer and central subfield retinal thickness', 'retinal thickness and brain volume', 'retinal thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0014432', 'cui_str': 'Enzyme inhibitor'}, {'cui': 'C4307343', 'cui_str': 'verubecestat'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",1785.0,0.337329,BACE inhibition by verubecestat was not associated with adverse effects on retinal thickness in patients with mild-to-moderate AD.,"[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Sergott', 'Affiliation': 'Wills Eye Hospital, and Annesley Eye Brain Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Annaswamy', 'Initials': 'A', 'LastName': 'Raji', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kost', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Sur', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Saheeda', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Locco', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Arpankumar', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Furtek', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Mattson', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Egan', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200735']
2885,32317658,The insufficiency of circulating miRNA and DNA as diagnostic tools or as biomarkers of treatment efficacy for Onchocerca volvulus.,"Skin snip evaluation for onchocerciasis has insufficient sensitivity when skin microfilarial (mf) densities are low, such as following ivermectin treatment. Mf density is suitable for assessing microfilaricidal efficacy but only serves as an indirect indicator of macrofilaricidal activity. We assessed circulating nucleic acids from Onchocerca volvulus as an alternative to skin snips. We screened a plasma sample set of infected individuals followed up at four, 12 and 21 months after microfilaricidal (ivermectin, n = four), macrofilaricidal (doxycycline, n = nine), or combination treatment (n = five). Two parasite-derived miRNAs, cel-miR-71-5p and bma-lin-4, and O-150 repeat DNA were assessed. Highly abundant DNA repeat families identified in the O. volvulus genome were also evaluated. miRNAs were detected in two of 72 plasma samples (2.8%) and two of 47 samples (4.3%) with microfilaridermia using RT-qPCR. O-150 DNA was detected in eight (44.4%) baseline samples by qPCR and the number of positives declined post-treatment. One doxycycline-treated individual remained O-150 positive. However, only 11 (23.4%) samples with microfilaridermia were qPCR-positive. Analysis by qPCR showed novel DNA repeat families were comparatively less abundant than the O-150 repeat. Circulating parasite-derived nucleic acids are therefore insufficient as diagnostic tools or as biomarkers of treatment efficacy for O. volvulus.",2020,"Skin snip evaluation for onchocerciasis has insufficient sensitivity when skin microfilarial (mf) densities are low, such as following ivermectin treatment.",[],"['microfilaricidal (ivermectin, n = four), macrofilaricidal (doxycycline, n = nine), or combination treatment', 'doxycycline']",['O-150 DNA'],[],"[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}]",,0.0375285,"Skin snip evaluation for onchocerciasis has insufficient sensitivity when skin microfilarial (mf) densities are low, such as following ivermectin treatment.","[{'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Macfarlane', 'Affiliation': 'Centre for Drugs and Diagnostics, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Quek', 'Affiliation': 'Centre for Drugs and Diagnostics, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Pionnier', 'Affiliation': 'Centre for Drugs and Diagnostics, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Turner', 'Affiliation': 'Centre for Drugs and Diagnostics, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wanji', 'Affiliation': 'Research Foundation for Tropical Diseases and the Environment (REFOTDE) and Department of Microbiology and Parasitology, University of Buea, Buea, Cameroon.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Wagstaff', 'Affiliation': 'Centre for Drugs and Diagnostics, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Taylor', 'Affiliation': 'Centre for Drugs and Diagnostics, Department of Tropical Disease Biology, Liverpool School of Tropical Medicine, Liverpool, United Kingdom. mark.taylor@lstmed.ac.uk.'}]",Scientific reports,['10.1038/s41598-020-63249-4']
2886,31039600,Accuracy Evaluation of Five Blood Glucose Monitoring Systems in Patients from Different Departments.,"BACKGROUND
Self-monitoring of blood glucose (SMBG) systems are expected to be accurate and provide reliable results. The international standard ISO (International Organization for Standardization) 15197:2013 is widely accepted for the accuracy evaluation for SMBG systems. Accuracy evaluation was performed for 5 different SMBG systems in patients from multi-departments at the hospital.
METHOD
A total of 120 patients from Changzhou Second People's Hospital (Changzhou, China) were randomized and enrolled in the study. Accuracy evaluation was performed for 5 different SMBG systems: Gold AQ (Sinocare), Freestyle Optium Xceed (Abbott), Contour TS (Bayer), OneTouch Ultra (J&J) and Accu-Chek Performa (Roche). For each system, comparison measurements were performed with YSI 2300 STAT PLUS Glucose and Lactate Analyzer and Roche Cobas 8000 Modular Analyzer.
RESULTS
All 5 systems showed that 100% of results fall within consensus error grid Zones A and B. Compared with YSI 2300 or Roche Cobas 8000 Modular Analyzer, Gold AQ system showed the highest accuracy. The linearity analysis also showed that Gold AQ had the highest correlation coefficient.
CONCLUSION
Compared with other SMBG systems, Gold AQ Glucose Monitoring System manufactured by Sinocare Inc. had the highest accuracy in measuring blood glucose level in patients from multi-departments at this hospital.",2020,"Compared with other SMBG systems, Gold AQ Glucose Monitoring System manufactured by Sinocare Inc. had the highest accuracy in measuring blood glucose level in patients from multi-departments at this hospital.","['Patients from Different Departments', 'patients from multi-departments at the hospital', ""120 patients from Changzhou Second People's Hospital (Changzhou, China""]","['Five Blood Glucose Monitoring Systems', 'Gold AQ', 'Gold AQ (Sinocare), Freestyle Optium Xceed (Abbott), Contour TS (Bayer), OneTouch Ultra (J&J) and Accu-Chek Performa (Roche']",['blood glucose level'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018026', 'cui_str': 'Gold'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}]",120.0,0.0304952,"Compared with other SMBG systems, Gold AQ Glucose Monitoring System manufactured by Sinocare Inc. had the highest accuracy in measuring blood glucose level in patients from multi-departments at this hospital.","[{'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Endocrinology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Suhua', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': ""Department of Hematology and Oncology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Suiyue', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': ""Department of Internal Medicine, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ""Department of Orthopedics, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Di', 'Affiliation': ""Department of Intensive Care Unit, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Yinian', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Nephropathy, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, China.""}, {'ForeName': 'Jinluo', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ""Department of Endocrinology, The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, China.""}]","Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association",['10.1055/a-0855-3726']
2887,32415231,Adherence and acceptability of a robot-assisted Pivotal Response Treatment protocol for children with autism spectrum disorder.,"The aim of this study is to present a robot-assisted therapy protocol for children with ASD based on the current state-of-the-art in both ASD intervention research and robotics research, and critically evaluate its adherence and acceptability based on child as well as parent ratings. The robot-assisted therapy was designed based on motivational components of Pivotal Response Treatment (PRT), a highly promising and feasible intervention focused at training ""pivotal"" (key) areas such as motivation for social interaction and self-initiations, with the goal of establishing collateral gains in untargeted areas of functioning and development, affected by autism spectrum disorders. Overall, children (3-8 y) could adhere to the robot-assisted therapy protocol (Mean percentage of treatment adherence 85.5%), showed positive affect ratings after therapy sessions (positive in 86.6% of sessions) and high robot likability scores (high in 79.4% of sessions). Positive likability ratings were mainly given by school-aged children (H(1) = 7.91, p = .005) and related to the movements, speech and game scenarios of the robot. Parent ratings on the added value of the robot were mainly positive (Mean of 84.8 on 0-100 scale), while lower parent ratings were related to inflexibility of robot behaviour.",2020,"Parent ratings on the added value of the robot were mainly positive (Mean of 84.8 on 0-100 scale), while lower parent ratings were related to inflexibility of robot behaviour.","['children with ASD', 'children with autism spectrum disorder']","['robot-assisted therapy was designed based on motivational components of Pivotal Response Treatment (PRT', 'robot-assisted therapy protocol', 'robot-assisted Pivotal Response Treatment protocol']","['high robot likability scores', 'movements, speech and game scenarios of the robot', 'Positive likability ratings', 'Adherence and acceptability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018817', 'cui_str': 'Atrial septal defect'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0241168,"Parent ratings on the added value of the robot were mainly positive (Mean of 84.8 on 0-100 scale), while lower parent ratings were related to inflexibility of robot behaviour.","[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van den Berk-Smeekens', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, P.O. Box 9104, 6500 HB, Nijmegen, The Netherlands. i.smeekens@karakter.com.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'van Dongen-Boomsma', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, P.O. Box 9104, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Manon W P', 'Initials': 'MWP', 'LastName': 'De Korte', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, P.O. Box 9104, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Jenny C', 'Initials': 'JC', 'LastName': 'Den Boer', 'Affiliation': 'Karakter Child and Adolescent Psychiatry, Postbus 68, 6710 BB, Ede, The Netherlands.'}, {'ForeName': 'Iris J', 'Initials': 'IJ', 'LastName': 'Oosterling', 'Affiliation': 'Karakter Child and Adolescent Psychiatry University Centre, Reinier Postlaan 12, 6525 GC, Nijmegen, The Netherlands.'}, {'ForeName': 'Nienke C', 'Initials': 'NC', 'LastName': 'Peters-Scheffer', 'Affiliation': 'Behavioural Science Institute, Radboud University Nijmegen, PO Box 9104, 6500 HE, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan K', 'Initials': 'JK', 'LastName': 'Buitelaar', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, P.O. Box 9104, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Emilia I', 'Initials': 'EI', 'LastName': 'Barakova', 'Affiliation': 'Faculty of Industrial Design, University of Technology, Eindhoven, P.O. Box 513 5600 MB, Eindhoven, The Netherlands.'}, {'ForeName': 'Tino', 'Initials': 'T', 'LastName': 'Lourens', 'Affiliation': 'TiViPE, Kanaaldijk ZW 11, 5706 LD, Helmond, The Netherlands.'}, {'ForeName': 'Wouter G', 'Initials': 'WG', 'LastName': 'Staal', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, P.O. Box 9104, 6500 HB, Nijmegen, The Netherlands.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Nijmegen Medical Centre, P.O. Box 9104, 6500 HB, Nijmegen, The Netherlands.'}]",Scientific reports,['10.1038/s41598-020-65048-3']
2888,32567820,Detection of immunoglobulin indexes by immunoturbidimetry: patients with chronic hepatitis B.,"BACKGROUND
The objective of this study was to explore the clinical effect of immunoglobulin test in patients with chronic hepatitis B.
METHODS
Fifty patients with chronic hepatitis B, 50 patients with liver failure and 50 patients with cirrhosis were selected from the Third People's Hospital of Baoji as experimental groups, and 50 healthy people as the control group. The immunoglobulin M (IgM), IgG and IgA levels in serum of the patients were tested by immunoturbidimetry before and after targeted treatment.
RESULTS
Before treatment, the level of Ig in patients with hepatitis B, liver failure and cirrhosis were significantly higher than those in normal people; the level of Ig in patients with hepatitis B were significantly lower than those in patients with liver failure and cirrhosis, and the level of Ig in patients in different groups increased significantly as the disease developed. After treatment, the level of Ig in patients in different groups decreased significantly; patients in the experimental group who had good treatment result had significant decrease of Ig level, while patients in the experimental group who had aggravated disease condition had significant increase of Ig level.
CONCLUSIONS
Detection of serum Ig level in patients with chronic hepatitis B can effectively help determine the condition of patients before and after treatment, so as to formulate appropriate treatment plan.",2020,"After treatment, the level of Ig in patients in different groups decreased significantly; patients in the experimental group who had good treatment result had significant decrease of Ig level, while patients in the experimental group who had aggravated disease condition had significant increase of Ig level.
","['patients with chronic hepatitis B', ""Fifty patients with chronic hepatitis B, 50 patients with liver failure and 50 patients with cirrhosis were selected from the Third People's Hospital of Baoji as experimental groups, and 50 healthy people as the control group"", 'immunoturbidimetry: patients with chronic hepatitis B']",['immunoglobulin test'],"['immunoglobulin M (IgM), IgG and IgA levels', 'Ig level', 'liver failure and cirrhosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2605250', 'cui_str': 'baoji'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3829558', 'cui_str': 'Immunoturbidimetry'}]","[{'cui': 'C0850992', 'cui_str': 'Immunoglobulin analyses'}]","[{'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]",50.0,0.0262663,"After treatment, the level of Ig in patients in different groups decreased significantly; patients in the experimental group who had good treatment result had significant decrease of Ig level, while patients in the experimental group who had aggravated disease condition had significant increase of Ig level.
","[{'ForeName': 'Zhiheng', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Laboratory Department, The Third People's Hospital of Baoji, Baoji, China.""}, {'ForeName': 'Yamei', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Laboratory Department, Baoji People's Hospital, China - ymyang_y@aliyun.com.""}]",Minerva medica,['10.23736/S0026-4806.20.06621-5']
2889,32398131,Human-centered design as a guide to intervention planning for non-communicable diseases: the BIGPIC study from Western Kenya.,"BACKGROUND
Non-communicable disease (NCD) care in Sub-Saharan Africa is challenging due to barriers including poverty and insufficient health system resources. Local culture and context can impact the success of interventions and should be integrated early in intervention design. Human-centered design (HCD) is a methodology that can be used to engage stakeholders in intervention design and evaluation to tailor-make interventions to meet their specific needs.
METHODS
We created a Design Team of health professionals, patients, microfinance officers, community health workers, and village leaders. Over 6 weeks, the Design Team utilized a four-step approach of synthesis, idea generation, prototyping, and creation to develop an integrated microfinance-group medical visit model for NCD. We tested the intervention with a 6-month pilot and conducted a feasibility evaluation using focus group discussions with pilot participants and community members.
RESULTS
Using human-centered design methodology, we designed a model for NCD delivery that consisted of microfinance coupled with monthly group medical visits led by a community health educator and a rural clinician. Benefits of the intervention included medication availability, financial resources, peer support, and reduced caregiver burden. Critical concerns elicited through iterative feedback informed subsequent modifications that resulted in an intervention model tailored to the local context.
CONCLUSIONS
Contextualized interventions are important in settings with multiple barriers to care. We demonstrate the use of HCD to guide the development and evaluation of an innovative care delivery model for NCDs in rural Kenya. HCD can be used as a framework to engage local stakeholders to optimize intervention design and implementation. This approach can facilitate the development of contextually relevant interventions in other low-resource settings.
TRIAL REGISTRATION
Clinicaltrials.gov, NCT02501746, registration date: July 17, 2015.",2020,"Over 6 weeks, the Design Team utilized a four-step approach of synthesis, idea generation, prototyping, and creation to develop an integrated microfinance-group medical visit model for NCD.","['pilot participants and community members', 'health professionals, patients, microfinance officers, community health workers, and village leaders', 'Sub-Saharan Africa', 'rural Kenya']","['Human-centered design (HCD', 'HCD']","['medication availability, financial resources, peer support, and reduced caregiver burden']","[{'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237758', 'cui_str': 'Non-commissioned officer'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}]","[{'cui': 'C5197739', 'cui_str': 'Human Centered Design'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",,0.0597296,"Over 6 weeks, the Design Team utilized a four-step approach of synthesis, idea generation, prototyping, and creation to develop an integrated microfinance-group medical visit model for NCD.","[{'ForeName': 'Claudia L', 'Initials': 'CL', 'LastName': 'Leung', 'Affiliation': 'Duke University Medical Center, 10 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Mackenzie', 'Initials': 'M', 'LastName': 'Naert', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Andama', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), P.O. Box 4606, Eldoret, 30100, Kenya.'}, {'ForeName': 'Rae', 'Initials': 'R', 'LastName': 'Dong', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edelman', 'Affiliation': 'Duke University Medical Center, 10 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Horowitz', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA.'}, {'ForeName': 'Peninah', 'Initials': 'P', 'LastName': 'Kiptoo', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), P.O. Box 4606, Eldoret, 30100, Kenya.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Manyara', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), P.O. Box 4606, Eldoret, 30100, Kenya.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Matelong', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), P.O. Box 4606, Eldoret, 30100, Kenya.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Matini', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), P.O. Box 4606, Eldoret, 30100, Kenya.'}, {'ForeName': 'Violet', 'Initials': 'V', 'LastName': 'Naanyu', 'Affiliation': 'Department of Behavioral Sciences, School of Medicine, College of Health Science, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nyariki', 'Affiliation': 'Academic Model Providing Access to Healthcare (AMPATH), P.O. Box 4606, Eldoret, 30100, Kenya.'}, {'ForeName': 'Sonak', 'Initials': 'S', 'LastName': 'Pastakia', 'Affiliation': 'Purdue University, Purdue University College of Pharmacy, Purdue-Kenya Partnership, West Lafayette, IN, PO Box 5760, Eldoret, 30100, Kenya.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Valente', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, 1 Gustave L. Levy Pl, New York, NY, 10029, USA.'}, {'ForeName': 'Gerald S', 'Initials': 'GS', 'LastName': 'Bloomfield', 'Affiliation': 'Duke University Medical Center, 10 Duke Medicine Circle, Durham, NC, 27710, USA.'}, {'ForeName': 'Jemima', 'Initials': 'J', 'LastName': 'Kamano', 'Affiliation': 'Department of Behavioral Sciences, School of Medicine, College of Health Science, Moi University College of Health Sciences, Eldoret, Kenya.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Vedanthan', 'Affiliation': 'New York University Grossman School of Medicine, 180 Madison Avenue, 8th Floor, New York, NY, 10016, USA. Rajesh.Vedanthan@nyulangone.org.'}]",BMC health services research,['10.1186/s12913-020-05199-1']
2890,32894785,Insufficient evidence exists to use histopathologic subtype to guide treatment of idiopathic multicentric Castleman disease.,"Idiopathic multicentric Castleman disease (iMCD) is a rare immunologic disorder characterized by systemic inflammation, multicentric lymphadenopathy, and organ dysfunction. Enlarged lymph nodes demonstrate a spectrum of characteristic but variable histopathologic features historically categorized into hyaline vascular (HV) (or hypervascular [HyperV] more recently), plasmacytic, or ""mixed."" Though the etiology is unknown, a pro-inflammatory cytokine storm, often involving interleukin-6 (IL-6), contributes to pathogenesis. Anti-IL-6 therapy with siltuximab is the only FDA- or EMA-approved treatment based on efficacy and safety in multiple studies. Importantly, no patients considered to have HV histopathology achieved the primary endpoint in the Phase II study. NCCN currently recommends siltuximab first-line for iMCD, except for patients considered to have HV histopathology. We investigated whether histopathologic subtype should guide siltuximab treatment decisions. Secondary analyses of clinical trial and real-world data revealed similar clinical benefit across histopathologic subtypes. Notably, only 18 of 79 patients in the Phase II study were consistently classified into histopathologic subtype by three independent review panels, demonstrating limited reliability to guide treatment decisions. Real-world data further demonstrate siltuximab's effectiveness in patients considered to have HV (or HyperV). Though histopathology is a critical component for diagnosis, there is insufficient evidence to guide treatment based solely on lymph node histopathologic subtype.",2020,Real-world data further demonstrate siltuximab's effectiveness in patients considered to have HV (or HyperV).,"['Idiopathic multicentric Castleman disease (iMCD', 'patients considered to have HV (or HyperV']",['NCCN'],[],"[{'cui': 'C5197665', 'cui_str': 'HHV-8-negative idiopathic multicentric Castleman disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020191', 'cui_str': 'Hyaline'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}]",[],[],,0.0157478,Real-world data further demonstrate siltuximab's effectiveness in patients considered to have HV (or HyperV).,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Fajgenbaum', 'Affiliation': 'Division of Translational Medicine and Human Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Division of Blood and Marrow Transplantation, UC San Diego Moores Cancer Center, La Jolla, California.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Wong', 'Affiliation': 'Sir Y.K. Pao Centre for Cancer & Department of Medicine & Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Sha Tin, Hong Kong.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chadburn', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Weill Cornell Medical College, New York, New York, USA.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Nasta', 'Affiliation': 'Division of Hematology/Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Gordan', 'Initials': 'G', 'LastName': 'Srkalovic', 'Affiliation': 'Sparrow Cancer Center, Edward W. Sparrow Hospital Association, Lansing, Michigan, USA.'}, {'ForeName': 'Sudipto', 'Initials': 'S', 'LastName': 'Mukherjee', 'Affiliation': 'Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Leitch', 'Affiliation': 'Division of Hematology, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Jayanthan', 'Affiliation': 'Department of Pediatrics, Montefiore Medical Center, Bronx, New York, USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ferrero', 'Affiliation': 'Division of Hematology, University of Torino, Torino, Italy.'}, {'ForeName': 'Yasuharu', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Pathology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Schey', 'Affiliation': ""Department of Haematological Medicine, Kings' College, London University, London, UK.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dispenzieri', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Oksenhendler', 'Affiliation': 'Department of Clinical Immunology, Hopital Saint-Louis, Paris, France.'}, {'ForeName': 'Pier Luigi', 'Initials': 'PL', 'LastName': 'Zinzani', 'Affiliation': 'Institute of Haematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Lechowicz', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'ICH Study Center GmbH & Co KG, Hamburg, Germany.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bagg', 'Affiliation': 'Department of Pathology & Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fossa', 'Affiliation': 'Department of Oncology, Oslo University Hospital - Norwegian Radium Hospital, Oslo, Norway.'}, {'ForeName': 'Megan S', 'Initials': 'MS', 'LastName': 'Lim', 'Affiliation': 'Department of Pathology & Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'van Rhee', 'Affiliation': 'Myeloma Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of hematology,['10.1002/ajh.25992']
2891,30889600,Learning Effect of Diagnosing Depth of Invasion Using Non-Extension Sign in Early Gastric Cancer.,"BACKGROUND
Determining the depth of invasion is important when considering therapeutic strategies for early gastric cancer (EGC). We determined the effects of learning the non-extension sign, that is, an index of T1b2 in EGC, on identifying its depth of invasion.
METHODS
Endoscopic images of 40 EGC cases (20 showing positive non-extension sign on endoscopy as T1b2 and 20 showing negative non-extension sign on endoscopy as T1a-T1b1) were randomly displayed on PowerPoint. Participants read endoscopy findings (pretest) and attended a 60-min lecture on how to read the non-extension sign. Then, they read the same images using the non-extension sign as the marker (posttest). The primary endpoint was a change in accuracy rate for determining the depth of invasion before and after attending the lecture, for nonexperts (< 80%).
RESULTS
Among 35 endoscopists, 12 were nonexperts; their test results were used for analyses. Accuracy rates for pretest and posttest among nonexperts were 75.2 and 82.5%, respectively, showing a significant increase in the accuracy rate after learning to read the non-extension sign (p = 0.003).
CONCLUSION
Nonexperts' diagnostic ability to determine the depth of invasion of EGC improved by learning to read the non-extension sign. Thus, the non-extension sign is considered a simple and useful diagnostic marker.",2020,"Accuracy rates for pretest and posttest among nonexperts were 75.2 and 82.5%, respectively, showing a significant increase in the accuracy rate after learning to read the non-extension sign (p = 0.003).
","['Early Gastric Cancer', 'early gastric cancer (EGC', 'Endoscopic images of 40 EGC cases (20 showing positive non-extension sign on endoscopy as T1b2 and 20 showing negative non-extension sign on endoscopy as T1a-T1b1']",[],"['change in accuracy rate for determining the depth of invasion', 'Accuracy rates', 'accuracy rate']","[{'cui': 'C0349530', 'cui_str': 'Early gastric cancer'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0475383', 'cui_str': 'Tumor stage T1a'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}]",,0.0242479,"Accuracy rates for pretest and posttest among nonexperts were 75.2 and 82.5%, respectively, showing a significant increase in the accuracy rate after learning to read the non-extension sign (p = 0.003).
","[{'ForeName': 'Teruyuki', 'Initials': 'T', 'LastName': 'Takeda', 'Affiliation': 'Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan, take5times@hotmail.co.jp.'}, {'ForeName': 'Suketo', 'Initials': 'S', 'LastName': 'So', 'Affiliation': 'Department of Gastroenterology, Tobata Kyoritsu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Sakurai', 'Affiliation': 'Department of Gastroenterology, Ashiya Central Hospital, Fukuoka, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Department of Gastroenterology, Steel Memorial Yawata Hospital, Fukuoka, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Endoscopy, Hospital of the University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Yada', 'Affiliation': 'Department of Gastroenterology, Onga Hospital, Fukuoka, Japan.'}, {'ForeName': 'Soichi', 'Initials': 'S', 'LastName': 'Itaba', 'Affiliation': 'Department of Gastroenterology, Kyushu Rosai Hospital, Fukuoka, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Yamagata', 'Affiliation': 'Department of Gastroenterology, Kokura Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Hirotada', 'Initials': 'H', 'LastName': 'Akiho', 'Affiliation': 'Department of Gastroenterology, Kitakyushu Municipal Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Noritaka', 'Initials': 'N', 'LastName': 'Takatsu', 'Affiliation': 'Department of Gastroenterology, Tagawa Municipal Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Gastroenterology, Wada Hospital, Oita, Japan.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Ohtsu', 'Affiliation': 'Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nagahama', 'Affiliation': 'Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': 'Department of Endoscopy, Fukuoka University Chikushi Hospital, Fukuoka, Japan.'}]",Digestion,['10.1159/000498845']
2892,32079967,Evaluating Ten Top Tips (10TT): Brief Dietary and Physical Activity Counseling in Rural Overweight and Obese Adults.,"Adults living in rural areas are at greater risk of becoming overweight and obese due to health care disparities. A pre-/postmatched cohort design was used to evaluate a brief weight-loss counseling intervention, Ten Top Tips (10TT), in a rural primary care setting. The rank sum scores for total weight-loss behaviors and the subscales for dietary changes, self-monitoring, physical activity, and psychological coping taken before and 12 weeks after the intervention differed significantly (P = .0001). Ten Top Tips offers rural community clinics an effective weight-loss intervention.",2020,"The rank sum scores for total weight-loss behaviors and the subscales for dietary changes, self-monitoring, physical activity, and psychological coping taken before and 12 weeks after the intervention differed significantly (P = .0001).","['Rural Overweight and Obese Adults', 'Adults living in rural areas']","['Brief Dietary and Physical Activity Counseling', 'weight-loss counseling intervention, Ten Top Tips (10TT']","['total weight-loss behaviors and the subscales for dietary changes, self-monitoring, physical activity, and psychological coping taken']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",,0.0142225,"The rank sum scores for total weight-loss behaviors and the subscales for dietary changes, self-monitoring, physical activity, and psychological coping taken before and 12 weeks after the intervention differed significantly (P = .0001).","[{'ForeName': 'Kassidy', 'Initials': 'K', 'LastName': 'Burr', 'Affiliation': 'Divisions of Nursing (Drs Burr, Roberson, and Onsomu) and Behavioral Sciences (Dr Yancu), Winston-Salem State University, North Carolina; and Novant Health, Primary Care South Rowan, China Grove, North Carolina (Ms Pritchard).'}, {'ForeName': 'Kristina B', 'Initials': 'KB', 'LastName': 'Roberson', 'Affiliation': ''}, {'ForeName': 'Elijah O', 'Initials': 'EO', 'LastName': 'Onsomu', 'Affiliation': ''}, {'ForeName': 'Cecile N', 'Initials': 'CN', 'LastName': 'Yancu', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pritchard', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000248']
2893,33247023,"Mental health of Urban Mothers (MUM) study: a multicentre randomised controlled trial, study protocol.","INTRODUCTION
Mental health disorders are common during pregnancy and the postnatal period and can have serious adverse effects on women and their children. The consequences for global mental health due to COVID-19 are likely to be significant and may have a long-term impact on the global burden of disease. Besides physical vulnerability, pregnant women are at increased risk of mental health problems such as anxiety, depression and post-traumatic stress disorder due to the consequences of social distancing. It can result in altered healthcare routines, less support from the family and friends, and in some cases, partners not being allowed to be present during prenatal visits, labour and delivery. Higher than expected, rates of perinatal anxiety and depression have been already reported during the pandemic. Pregnant women may also feel insecure and worried about the effects of COVID-19 on their unborn child if they get infected during pregnancy. Today, young urban women are used to using internet services frequently and efficiently. Therefore, providing mental health support to pregnant women via internet may be effective in ameliorating their anxiety/depression, reducing the risk of serious mental health disorders, and lead to improved maternal and perinatal outcomes.
OVERARCHING AIM
Our aim is to explore the effectiveness of a web-based psychosocial peer-to-peer support intervention in reducing the risk and severity of perinatal mental health disorders and preventing adverse pregnancy outcomes among pregnant women living in metropolitan urban settings.
METHODS AND ANALYSIS
We plan to conduct a multicentre prospective randomised controlled trial, Mental health of Urban Mothers trial. Pregnant women living in large metropolitan cities will be recruited using internet-based application through non-profit organisations' websites. The women who consent will be randomised to receive a web-based peer-to-peer support intervention or usual care. Data will be analysed to identify the effects of intervention on Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores as well as pregnancy outcomes. The impact of COVID-19 pandemic on maternal stress will be assesed using Impact Event Scale-R. Any differences in outcomes between cities will be addressed in subgroup analyses.
ETHICS AND DISSEMINATION
The study will be conducted according to the principles of Good Clinical Practice and will follow the ethical principles of the Declaration of Helsinki. The study protocol has been approved by the ethical review board of Chinese University of Hong Kong (IRB number 2019-8170) and Shanghai Center for Women's and Children's Health (international review board (IRB) number 2020-F001-12). The results will be disseminated at national and international scientific conferences, published in peer-reviewed medical journals and spread to the public through social media, news outlets and podcasts.
TRIAL REGISTRATION NUMBER
NCT04363177; Trial sponsor Karolinska Institute, CLINTEC, Stockholm, Sweden.",2020,Data will be analysed to identify the effects of intervention on Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores as well as pregnancy outcomes.,"['Pregnant women living in large metropolitan cities', 'Pregnant women', ""Chinese University of Hong Kong (IRB number 2019-8170) and Shanghai Center for Women's and Children's Health (international review board"", 'Mental health of Urban Mothers trial', 'pregnant women living in metropolitan urban settings', 'young urban women']","['web-based psychosocial peer-to-peer support intervention', 'web-based peer-to-peer support intervention or usual care']","['Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores', 'rates of perinatal anxiety and depression', 'adverse pregnancy outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",,0.145914,Data will be analysed to identify the effects of intervention on Edinburgh Postnatal Depression Score and Generalised Anxiety Disorder 7 scores as well as pregnancy outcomes.,"[{'ForeName': 'Simone Eliane', 'Initials': 'SE', 'LastName': 'Schwank', 'Affiliation': 'CLINTEC, Karolinska Institute, Stockholm, Sweden simone.schwank@ki.se.'}, {'ForeName': 'Ho-Fung', 'Initials': 'HF', 'LastName': 'Chung', 'Affiliation': 'Psychiatry, The University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Hsu', 'Affiliation': 'Psychological and Brain Sciences, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Shih-Chien', 'Initials': 'SC', 'LastName': 'Fu', 'Affiliation': 'Counseling Psychology, National Taipei University of Education, Taipei, Taiwan.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Du', 'Affiliation': 'Department of Research and Education, Tongji University, Shanghai, Shanghai, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Research and Education, Tongji University, Shanghai, Shanghai, China.'}, {'ForeName': 'Hsuan-Ying', 'Initials': 'HY', 'LastName': 'Huang', 'Affiliation': 'Anthropology, The Chinese University Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': ""Department of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.""}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Acharya', 'Affiliation': ""Women's Health and Perinatology Research Group, Department of Clinical Medicine, UiT-The Arctic University of Norway, Tromsø, Norway.""}]",BMJ open,['10.1136/bmjopen-2020-041133']
2894,33251832,How does nepafenac affect the choroidal thickness after uneventful cataract surgery?,"PURPOSE
To investigate the effects of topical nepafenac on choroidal thickness (CT) following uneventful phacoemulsification surgery (UPS) using enhanced depth imaging optical coherence tomography (EDI-OCT).
METHODS
This prospective study included 45 randomly selected eyes (23 eyes of 23 patients used nepafenac (nepafenac group) and 22 eyes of 22 control patients did not use nepafenac (nepafenac-free group)) undergoing small-incision UPS. All participants underwent full ophthalmologic examination. CT measurements were performed at subfoveal, 1.0 mm temporal, and 1.0 mm nasal using the EDI-OCT preoperatively, 1 day, 1 week, and 1 month postoperatively.
RESULTS
The mean subfoveal, nasal, and temporal CT in the nepafenac-free group had changed from 268.95 ± 63.59 μm to 283.36 ± 65.63 μm, 237.22 ± 64.09 μm to 253.09 ± 67.27 μm, and 235.95 ± 75.22 μm to 259.09 ± 63.66 μm preoperatively to 1 month postoperatively, respectively ( p < 0.001, p < 0.001, p < 0.001, respectively). The mean subfoveal, nasal, and temporal CT in the nepafenac group had changed from 259.65 ± 55.99 μm to 276.65 ± 59.21 μm, 236.34 ± 55.40 μm to 251.00 ± 62.39 μm, and 247.56 ± 50.88 μm to 261.13 ± 53.73 μm preoperatively to 1 month postoperatively, respectively ( p < 0.001, p < 0.001, p < 0.001, respectively). The postoperative CT continued to increase significantly during the follow-up period in two groups. However, compared to the change from baseline to month 1, there was not a statistically significant difference between the groups at subfoveal, nasal, and temporal CT ( p : 0.633, p : 0.865, and p : 0.328, respectively).
CONCLUSION
UPS may cause a significant increase in CT. Although increasing in the CT was lower in the nepafenac group than the nepafenac-free group, there was not a statistically significant difference between the groups.",2020,"Although increasing in the CT was lower in the nepafenac group than the nepafenac-free group, there was not a statistically significant difference between the groups.","['45 randomly selected eyes (23 eyes of 23 patients used', 'group) and 22 eyes of 22 control patients did not use']","['nepafenac (nepafenac-free group)) undergoing small-incision UPS', 'uneventful phacoemulsification surgery (UPS', 'topical nepafenac', 'nepafenac (nepafenac', 'nepafenac']","['CT', 'mean subfoveal, nasal, and temporal CT', 'postoperative CT', 'CT measurements', 'choroidal thickness (CT', 'choroidal thickness']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0961209', 'cui_str': 'nepafenac'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",45.0,0.0160746,"Although increasing in the CT was lower in the nepafenac group than the nepafenac-free group, there was not a statistically significant difference between the groups.","[{'ForeName': 'Selim', 'Initials': 'S', 'LastName': 'Cevher', 'Affiliation': 'Faculty of Medicine, Department of Ophthalmology, Hitit University, Çorum, Turkey.'}, {'ForeName': 'Gülçin', 'Initials': 'G', 'LastName': 'Aydoğdu', 'Affiliation': 'Faculty of Medicine, Department of Biostatistics, Hitit University, Çorum, Turkey.'}]",European journal of ophthalmology,['10.1177/1120672120976041']
2895,33251823,A Pilot Randomized Controlled Trial of Acceptance and Commitment Therapy Guided Self-Help for Overweight and Obese Adults High in Weight Self-Stigma.,"Weight self-stigma, in which individuals internalize stigmatizing messages about weight, is a prevalent problem that contributes to poor quality of life and health. This pilot randomized controlled trial evaluated acceptance and commitment therapy (ACT) guided self-help using The Diet Trap for 55 overweight/obese adults high in weight self-stigma. Participants were randomized to the ACT self-help book plus phone coaching (GSH-P; n = 17), self-help book plus email prompts only (GSH-E; n = 20), or a waitlist condition ( n = 18), with online self-report assessments at baseline and posttreatment (8 weeks later). Participants reported high satisfaction ratings and engagement with the ACT self-help book, with no differences between GSH-P and GSH-E. Both GSH-P and GSH-E improved weight self-stigma relative to waitlist with large effect sizes. There were mixed findings for health outcomes. The GSH-P condition improved more on healthy eating behaviors and general physical activity, but neither ACT condition improved more than waitlist on self-reported body mass index, emotional eating, and a second measure of physical activity. Results suggest an ACT self-help book with email prompts can reduce weight self-stigma and potentially improve some health behavior outcomes. Phone coaching may provide additional benefits for generalizing ACT to diet and physical activity.",2020,This pilot randomized controlled trial evaluated acceptance and commitment therapy (ACT) guided self-help using The Diet Trap for 55 overweight/obese adults high in weight self-stigma.,"['Overweight and Obese Adults High in Weight Self-Stigma', '55 overweight/obese adults high in weight self-stigma']","['GSH-P and GSH-E', 'Phone coaching', 'acceptance and commitment therapy (ACT) guided self-help using The Diet Trap', 'ACT self-help book plus phone coaching (GSH-P; n \u2009=\u200917), self-help book plus email prompts only (GSH-E; n \u2009=\u200920), or a waitlist condition', 'Acceptance and Commitment Therapy Guided Self-Help']","['weight self-stigma', 'healthy eating behaviors and general physical activity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",55.0,0.0613666,This pilot randomized controlled trial evaluated acceptance and commitment therapy (ACT) guided self-help using The Diet Trap for 55 overweight/obese adults high in weight self-stigma.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Potts', 'Affiliation': 'Partnership Health Center, Missoula, MT, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Krafft', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Utah State University, Logan, UT, USA.'}]",Behavior modification,['10.1177/0145445520975112']
2896,33251815,Effects of Individualized Dietary Phosphate Control Program With a Smartphone Application in Hemodialysis Patients in Taiwan.,"BACKGROUND
Hyperphosphatemia in end-stage renal disease patients is prevalent and associated with increasing cardiac mortality. Restricting dietary phosphate intake is a key element in controlling hyperphosphatemia, but most patients fail due to lack of knowledge and sustainability. In this study, we aimed to examine whether incorporating a smartphone application (APP) into a multidisciplinary caring system can decrease the prevalence of hyperphosphatemia in hemodialysis patients.
METHODS
We designed a quasi-experimental study to enroll patients undergoing regular hemodialysis and assigned them to receive APP-assisted caring program (ACP group, n = 30) or standard education caring program (SCP group, n = 30). Both caring programs targeting dietary phosphate control were administered. Patients' general characteristics, self-care efficacy scales, knowledge test of phosphate control, and results of monthly blood biochemistry were analyzed.
FINDINGS
Knowledge of diet phosphate control and self-care efficacy were significantly higher in the ACP group. Notably, the knowledge improvement was higher in patients aged over 60 years. Compared to the SCP group, the percentage of patients with successful hyperphosphatemia control was significantly higher in the ACP group ( p = 0.0398).
CONCLUSION
The APP-assisted caring program benefits patients with regular hemodialysis to achieve better dietary phosphate control without compromising proper protein intake.",2020,"Compared to the SCP group, the percentage of patients with successful hyperphosphatemia control was significantly higher in the ACP group ( p = 0.0398).
","['Hemodialysis Patients in Taiwan', 'hemodialysis patients', 'enroll patients undergoing regular hemodialysis and assigned them to receive']","['APP-assisted caring program (ACP group, n = 30) or standard education caring program (SCP group, n = 30', 'ACP', 'SCP', 'Individualized Dietary Phosphate Control Program', 'smartphone application (APP']","['knowledge improvement', 'self-care efficacy', 'general characteristics, self-care efficacy scales, knowledge test of phosphate control, and results of monthly blood biochemistry', 'prevalence of hyperphosphatemia', 'successful hyperphosphatemia control']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0001369', 'cui_str': 'Acyl Carrier Protein'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1145610', 'cui_str': 'sodium cellulose phosphate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0085681', 'cui_str': 'Hyperphosphatemia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",,0.0157408,"Compared to the SCP group, the percentage of patients with successful hyperphosphatemia control was significantly higher in the ACP group ( p = 0.0398).
","[{'ForeName': 'Yung-Chen', 'Initials': 'YC', 'LastName': 'Chiang', 'Affiliation': 'Division of Nephrology, Departments of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei.'}, {'ForeName': 'Ya-Ping', 'Initials': 'YP', 'LastName': 'Chang', 'Affiliation': 'Division of Nephrology, Departments of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei.'}, {'ForeName': 'Ssu-Chin', 'Initials': 'SC', 'LastName': 'Lin', 'Affiliation': 'Division of Nephrology, Department of Medicine, Hualien Armed Forces General Hospital, Xincheng.'}, {'ForeName': 'Chin', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Research and Development, National Defense Medical Center, Taipei.'}, {'ForeName': 'Pi-Hsiu', 'Initials': 'PH', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, Departments of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei.'}, {'ForeName': 'Yu-Juei', 'Initials': 'YJ', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, Departments of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei.'}, {'ForeName': 'Tsung-Jui', 'Initials': 'TJ', 'LastName': 'Wu', 'Affiliation': 'Division of Nephrology, Departments of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei.'}]",Biological research for nursing,['10.1177/1099800420975504']
2897,33251173,Effect of an Appearance-Based vs. a Health-Based Sun-Protective Intervention on French Summer Tourists' Behaviors in a Cluster Randomized Crossover Trial: The PRISME Protocol.,"Background: Sun exposure has short- and long-term adverse effects on eyes, skin, and the immune system. The most serious effect, melanoma, is largely attributable to natural ultraviolet radiation. Its prevalence is steadily increasing in fair-skinned populations in most European countries. Despite annual prevention campaigns, the French population continues to be overexposed to the sun and under-protected. Social and psychosocial characteristics may play an important role in sun protection determinants. Overexposure is partially motivated by a desire to tan oneself for aesthetic reasons. During summer, intense exposure constitutes a major risk factor for melanoma, making tourists a particularly high-risk population. Literature reviews concluded that appearance-based interventions highlighting the aesthetic effects of sun exposure on skin photoaging showed promise in terms of improving sun-exposure and sun-protection behaviors, especially among younger people, but that more rigorous studies were needed. In this context, we implemented the PRISME study to: - identify the determinants, in particular social and psychosocial, of sun-protection of French summer tourists visiting the Mediterranean coastline; - design two prevention interventions grounded in psychosocial theories; - compare the impact of both interventions on tourists' sun-protection behaviors, and identify the determinants influencing this impact. This paper presents the methodology of the PRISME study. Methods: During summer 2019, we conducted a cluster randomized crossover trial to compare two prevention interventions, one based on health-related messages (health effects information, phototype calculation), the other on appearance-related messages (photoaging information, ultraviolet photography), among French tourists aged 12-55 years old in coastline campsites in the French region of Occitanie. Both interventions were anchored in the theory of planned behavior and in the transtheoretical model. The interventions' impact was measured using face-to-face questionnaires and skin color measurements both immediately before and 4 days after the interventions. A second follow-up, using an online questionnaire, will be conducted in September 2020 to measure the longer-term effects of both interventions. Discussion: Despite certain study limitations, PRISME take into consideration several known methodological gaps. The study's results will enable to evaluate the efficacy of the promising appearance-based approach in France, and to identify vulnerable sub-populations and mechanisms to improve sun-protection behaviors of French tourists.",2020,"Literature reviews concluded that appearance-based interventions highlighting the aesthetic effects of sun exposure on skin photoaging showed promise in terms of improving sun-exposure and sun-protection behaviors, especially among younger people, but that more rigorous studies were needed.",['French tourists aged 12-55 years old in coastline campsites in the French region of Occitanie'],"['Overexposure', 'Appearance-Based vs. a Health-Based Sun-Protective Intervention']",['sun-exposure and sun-protection behaviors'],"[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0532438,"Literature reviews concluded that appearance-based interventions highlighting the aesthetic effects of sun exposure on skin photoaging showed promise in terms of improving sun-exposure and sun-protection behaviors, especially among younger people, but that more rigorous studies were needed.","[{'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Durand', 'Affiliation': 'Santé Publique France (SpF), Regions Division, Occitanie, Toulouse, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Catelinois', 'Affiliation': 'Santé Publique France (SpF), Regions Division, Occitanie, Toulouse, France.'}, {'ForeName': 'Apolline', 'Initials': 'A', 'LastName': 'Bord', 'Affiliation': 'Institut du Cancer de Montpellier (ICM), Prevention Department Epidaure, Montpellier, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Richard', 'Affiliation': 'Santé Publique France (SpF), Support, Processing and Data Analysis Division, Saint-Maurice, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Bidondo', 'Affiliation': 'Santé Publique France (SpF), Support, Processing and Data Analysis Division, Saint-Maurice, France.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Ménard', 'Affiliation': 'Santé Publique France (SpF), Health Prevention and Promotion Division, Saint-Maurice, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cousson-Gélie', 'Affiliation': 'Institut du Cancer de Montpellier (ICM), Prevention Department Epidaure, Montpellier, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Mahé', 'Affiliation': 'Hospital center of Argenteuil-Dermatology Department, Argenteuil, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Mouly', 'Affiliation': 'Santé Publique France (SpF), Regions Division, Occitanie, Toulouse, France.'}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Delpierre', 'Affiliation': 'UMR1027, Université de Toulouse, UPS, Inserm, Toulouse, France.'}]",Frontiers in public health,['10.3389/fpubh.2020.569857']
2898,33251057,Effect of Topical Capsaicin on Painful Sensory Peripheral Neuropathy in Patients with Type 2 Diabetes: A Double-Blind Placebo-Controlled Randomised Clinical Trial.,"Objective The aim of this study was to evaluate the efficacy of capsaicin in inducing significant pain relief in a population of sub-Saharan African type 2 diabetic patients with painful peripheral neuropathy. Design This was a prospective double-blind placebo-controlled randomised clinical trial. Setting A single tertiary-level hospital diabetes center in Yaounde, Cameroon. Participants Twenty-two participants with type 2 diabetes mellitus, presenting with painful diabetic neuropathy, aged 18 years and above. Intervention Participants were equally randomised to capsaicin or placebo. Each drug was to be applied on the lower limbs thrice daily. Follow-up was done every two weeks for eight weeks. Main outcome measure Reduction in the median pain score from baseline, as assessed by the Visual Analogue Scale. Results Twenty-two participants aged 57.5 (50-60) years with a median pain intensity of 6.8 units in the capsaicin group and 5.8 units in the placebo group were included; at inclusion, there was no significant difference in the two groups (p=0.29). After two weeks, the value of pain intensity was 3.3 [2.5-4.0] vs 5.0 [4.0-7.4] (p=0.003); at week four, 3.0 [2.5-3.3] vs 5.0 [4.2-5.5] (p=0,02); at week six, 3.3 [2.5-4.0] vs 4.8 [4.0-6.0] (p=0.03); and at week eight, 6.6 [6.0-7.0] vs 5.2 [5.0-6.0] (p=0.54) for capsaicin and placebo respectively. Conclusion This study, carried out due to a paucity of information on the effect of capsaicin and painful diabetic neuropathy in sub-Saharan African diabetes patients, shows that capsaicin significantly reduces neuropathic pain with worsening after eight weeks of use. Trial registration number Pan Africa Trial Registry: PACTR202003714748946.",2020,"After two weeks, the value of pain intensity was 3.3 [2.5-4.0] vs 5.0 [4.0-7.4] (p=0.003); at week four, 3.0 [2.5-3.3] vs 5.0 [4.2-5.5] (p=0,02); at week six, 3.3 [2.5-4.0] vs 4.8 [4.0-6.0] (p=0.03); and at week eight, 6.6 [6.0-7.0] vs 5.2 [5.0-6.0] (p=0.54) for capsaicin and placebo respectively.","['sub-Saharan African diabetes patients', 'Setting A single tertiary-level hospital diabetes center in Yaounde, Cameroon', 'Twenty-two participants aged 57.5 (50-60) years with a median pain intensity of 6.8 units in the capsaicin group and 5.8 units in the', 'Participants Twenty-two participants with type 2 diabetes mellitus, presenting with painful diabetic neuropathy, aged 18 years and above', 'population of sub-Saharan African type 2 diabetic patients with painful peripheral neuropathy', 'Patients with Type 2 Diabetes']","['placebo', 'Topical Capsaicin', 'capsaicin or placebo', 'Placebo', 'capsaicin']","['pain relief', 'neuropathic pain', 'value of pain intensity', 'Visual Analogue Scale', 'median pain score', 'Painful Sensory Peripheral Neuropathy']","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0006802', 'cui_str': 'Cameroon'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0751074', 'cui_str': 'Neuralgia, Diabetic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3210186', 'cui_str': 'Capsaicin-containing product in transdermal dose form'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}]",22.0,0.731575,"After two weeks, the value of pain intensity was 3.3 [2.5-4.0] vs 5.0 [4.0-7.4] (p=0.003); at week four, 3.0 [2.5-3.3] vs 5.0 [4.2-5.5] (p=0,02); at week six, 3.3 [2.5-4.0] vs 4.8 [4.0-6.0] (p=0.03); and at week eight, 6.6 [6.0-7.0] vs 5.2 [5.0-6.0] (p=0.54) for capsaicin and placebo respectively.","[{'ForeName': 'Batakeh B', 'Initials': 'BB', 'LastName': 'Agoons', 'Affiliation': 'Internal Medicine, Bafang District Hospital, Bafang, CMR.'}, {'ForeName': 'Mesmin', 'Initials': 'M', 'LastName': 'Dehayem Yefou', 'Affiliation': 'Diabetes and Endocrinology, Central Hospital, Yaounde, CMR.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Katte', 'Affiliation': 'Public Health Sciences, Faculty of Medicine and Biomedical Sciences, University of Yaounde 1, Yaounde, CMR.'}, {'ForeName': 'Martine Claude', 'Initials': 'MC', 'LastName': 'Etoa Etoga', 'Affiliation': 'Diabetes and Endocrinology, Central Hospital, Yaounde, CMR.'}, {'ForeName': 'Dayawa D', 'Initials': 'DD', 'LastName': 'Agoons', 'Affiliation': 'Medicine, University of Pittsburgh Medical Center Pinnacle Hospital, Harrisburg, USA.'}, {'ForeName': 'Faustin', 'Initials': 'F', 'LastName': 'Yepnjio', 'Affiliation': 'Neurology, Central Hospital, Yaounde, CMR.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Boli', 'Affiliation': 'Diabetes and Endocrinology, Central Hospital, Yaounde, Yaounde, CMR.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Wasnyo', 'Affiliation': 'Emergency, Central Hospital, Yaounde, Yaounde, CMR.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Sobngwi', 'Affiliation': 'Diabetes and Endocrinology, Central Hospital, Yaounde, CMR.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Mbanya', 'Affiliation': 'Diabetes and Endocrinology, Central Hospital, Yaounde, CMR.'}]",Cureus,['10.7759/cureus.11147']
2899,33251022,A randomized trial of vorinostat with treatment interruption after initiating antiretroviral therapy during acute HIV-1 infection.,"Objective and Design
A randomized, open-label pilot study in individuals treated with antiretroviral therapy (ART) since acute HIV infection (AHI) with a regimen including a histone deacetylase inhibitor to induce HIV from latency and control HIV replication during subsequent treatment interruption (TI).
Methods
Fifteen participants who initiated ART at AHI were randomized to vorinostat/hydroxychloroquine/maraviroc (VHM) plus ART (n = 10) or ART alone (n = 5). The VHM arm received three 14-day vorinostat cycles within 10 weeks before TI. ART was resumed for plasma viral load (VL) > 1,000 HIV RNA copies/mL. Primary outcome was proportion of participants on VHM + ART versus ART only with VL < 50 copies/mL for 24 weeks after TI.
Results
Fifteen participants on ART (median: 178 weeks: range 79-295) enrolled. Two on VHM + ART experienced serious adverse events. Fourteen participants underwent TI; all experienced VL rebound with no difference in time between arms: VHM + ART (n = 9) median: 4 weeks and ART only (n = 5) median: 5 weeks. VHM induced a 2.2-fold increase in VL (p = 0.008) by single-copy HIV RNA assay after the first cycle. Neopterin levels increased significantly following the first two cycles. After VHM treatment, the frequencies of peripheral blood mononuclear cells harboring total HIV DNA and cell-associated RNA were unchanged. All participants achieved VL suppression following ART re-initiation.
Conclusions
Administration of VHM increased HIV VL in plasma, but this was not sustained. VHM did not impact time to viral rebound following TI and had no impact on the size of the HIV reservoir, suggesting that HIV reservoir elimination will require alternative treatment strategies.",2020,"After VHM treatment, the frequencies of peripheral blood mononuclear cells harboring total HIV DNA and cell-associated RNA were unchanged.","['individuals treated with antiretroviral therapy (ART) since acute HIV infection (AHI', 'acute HIV-1 infection', 'Fifteen participants who initiated ART at AHI', 'Fifteen participants on ART (median: 178 weeks: range 79-295) enrolled']","['VHM\xa0\u200b+\xa0\u200bART', 'VHM', 'vorinostat/hydroxychloroquine/maraviroc (VHM) plus ART (n\xa0\u200b=\xa0\u200b10) or ART alone']","['VL suppression', 'VL', 'plasma viral load (VL)\xa0\u200b', 'frequencies of peripheral blood mononuclear cells harboring total HIV DNA and cell-associated RNA', 'Neopterin levels', 'proportion of participants on VHM\xa0\u200b+\xa0\u200bART versus ART only with VL\xa0\u200b']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0343752', 'cui_str': 'Acute HIV infection'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0486959', 'cui_str': 'Human immunodeficiency virus DNA'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",15.0,0.264475,"After VHM treatment, the frequencies of peripheral blood mononuclear cells harboring total HIV DNA and cell-associated RNA were unchanged.","[{'ForeName': 'Eugène D M B', 'Initials': 'EDMB', 'LastName': 'Kroon', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Jintanat', 'Initials': 'J', 'LastName': 'Ananworanich', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Pagliuzza', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Ajantha', 'Initials': 'A', 'LastName': 'Rhodes', 'Affiliation': 'The Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Nittaya', 'Initials': 'N', 'LastName': 'Phanuphak', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Trautmann', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Mitchell', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Chintanaphol', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Jintana', 'Initials': 'J', 'LastName': 'Intasan', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Suteeraporn', 'Initials': 'S', 'LastName': 'Pinyakorn', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Khuntalee', 'Initials': 'K', 'LastName': 'Benjapornpong', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'J Judy', 'Initials': 'JJ', 'LastName': 'Chang', 'Affiliation': 'The Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Donn J', 'Initials': 'DJ', 'LastName': 'Colby', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Nitiya', 'Initials': 'N', 'LastName': 'Chomchey', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'James L K', 'Initials': 'JLK', 'LastName': 'Fletcher', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Eubanks', 'Affiliation': 'Cooper Human Systems, Nashua, NH, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Cooper Human Systems, Nashua, NH, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kapson', 'Affiliation': 'Cooper Human Systems, Nashua, NH, USA.'}, {'ForeName': 'Ashanti', 'Initials': 'A', 'LastName': 'Dantanarayana', 'Affiliation': 'The Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Surekha', 'Initials': 'S', 'LastName': 'Tennakoon', 'Affiliation': 'The Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gorelick', 'Affiliation': 'AIDS and Cancer Virus Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Maldarelli', 'Affiliation': 'Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Initiative, Seoul, Republic of Korea.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Spudich', 'Affiliation': 'Department of Neurology, Yale University School of Medicine, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Chomont', 'Affiliation': 'Centre de Recherche du CHUM and Department of Microbiology, Infectiology and Immunology, Université de Montréal, Montreal, Canada.'}, {'ForeName': 'Praphan', 'Initials': 'P', 'LastName': 'Phanuphak', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': 'Sharon R', 'Initials': 'SR', 'LastName': 'Lewin', 'Affiliation': 'The Peter Doherty Institute for Infection and Immunity, University of Melbourne and Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'de Souza', 'Affiliation': 'SEARCH, Thai Red Cross AIDS Research Centre, Bangkok, Thailand.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of virus eradication,['10.1016/j.jve.2020.100004']
2900,33250965,Diagnostic value of novel retroflexion colonoscopy in the right colon: A randomized controlled trial.,"BACKGROUND
Colonoscopy is the accepted gold standard for the detection of colorectal cancer. However, colonoscopy is less effective in preventing colon cancer in the right side compared with the left side.
AIM
To investigate the feasibility of a novel type of retroflexion colonoscope, EC-3490Ti colonoscope, for detection of proximal colon lesions.
METHODS
In this prospective trial, we recruited patients who underwent colonoscopy for screening or surveillance. When the endoscopists could not grasp the whole observation of the right-side colon mucosa in the forward view (FV), insertion and withdrawal were repeatedly performed in the FV group with the EC38-i10F colonoscope while retroflexion was performed in the retroflexed view (RV) group with the EC-3490Ti colonoscope. Adenoma detection rate, the total number of adenomas per positive participant, the success rate of retroflexion, and endoscope withdrawal time were recorded and compared.
RESULTS
The total adenoma detection rate (39.3% vs 37.7%, P = 0.646) did not show any significant difference between the two groups. However, the polyp detection rate (59.6% vs 51.0%, P = 0.002), adenoma detection rate in the right colon (21.6% vs 14.4%, P = 0.012), and the total number of adenomas per positive participant (2.1 vs 1.7, P = 0.011) reached statistical significance. Retroflexion was achieved in 91.7% of our cohort. Compared with the FV group, the withdrawal time was significantly prolonged in the RV group (586.1 ± 124.4 s vs 508.8 ± 129.6 s, P < 0.001). In contrast, the proportion of additional ancillary pressure decreased (27.4% vs 45.7%, P < 0.001), and the visual analog scale pain scores did not increase (2.7 ± 1.4 vs 2.8 ± 1.4, P = 0.377).
CONCLUSION
Retroflexion in the proximal colon could be performed successfully and safely with the EC-3490Ti colonoscope. This maneuver could detect more adenomas effectively.",2020,"The total adenoma detection rate (39.3% vs 37.7%, P = 0.646) did not show any significant difference between the two groups.","['right colon', 'patients who underwent colonoscopy for screening or surveillance']","['retroflexion colonoscope, EC-3490Ti colonoscope', 'EC-3490Ti colonoscope', 'novel retroflexion colonoscopy']","['total number of adenomas per positive participant', 'withdrawal time', 'Adenoma detection rate, the total number of adenomas per positive participant, the success rate of retroflexion, and endoscope withdrawal time', 'visual analog scale pain scores', 'total adenoma detection rate', 'proportion of additional ancillary pressure', 'Retroflexion', 'polyp detection rate', 'adenoma detection rate']","[{'cui': 'C1305188', 'cui_str': 'Right colon structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}]","[{'cui': 'C0333044', 'cui_str': 'Posterior displacement'}, {'cui': 'C0180022', 'cui_str': 'Colonoscope'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}]",,0.0585501,"The total adenoma detection rate (39.3% vs 37.7%, P = 0.646) did not show any significant difference between the two groups.","[{'ForeName': 'Wen-Kun', 'Initials': 'WK', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Peking University Ninth School of Clinical Medicine, Beijing 100038, China.'}, {'ForeName': 'Ya-Dan', 'Initials': 'YD', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Kui-Liang', 'Initials': 'KL', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Chun-Mei', 'Initials': 'CM', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China.'}]",World journal of gastrointestinal oncology,['10.4251/wjgo.v12.i11.1336']
2901,33250822,Is Sham Training Still Training? An Alternative Control Group for Attentional Bias Modification.,,2020,,[],['Sham Training'],[],[],"[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],,0.0115591,,"[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tiggemann', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kemps', 'Affiliation': 'School of Psychology, Flinders University, Adelaide, SA, Australia.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.583518']
2902,33250741,RT-qPCR versus Digital PCR: How Do They Impact Differently on Clinical Management of Chronic Myeloid Leukemia Patients?,"Real-time quantitative PCR (RT-qPCR) is the gold standard to quantify the BCR-ABL1 transcript for molecular response monitoring in chronic myeloid leukemia (CML) patients, and it plays a pivotal role in clinical decision-making process, even if it presents technical limits. Increasing data suggest that digital PCR (dPCR) is more accurate and reliable than RT-qPCR in CML minimal residual disease monitoring and in patients' selection for treatment discontinuation. But what about the identification of treatment discontinuation failures? We present the case of a CML patient enrolled both in a study aiming to comparatively assess molecular response by RT-qPCR and dPCR and in the progressive arm of the OPTkIMA trial. This is a phase III trial including CML patients randomized to receive a fixed versus a progressive intermittent tyrosine kinase inhibitor regimen. At 24 months, because of two consecutive detections of MR2.0 by RT-qPCR, the patient resumed daily treatment. Conversely, dPCR revealed a stability of molecular response and even a slight decreasing of transcript over time. An additional specimen was sampled one month after the first MR2.0 detection because of clinical decision: RT-qPCR resulted MR3.0 and dPCR confirmed the transcript's stability. Nowadays, the resumption of therapy is RT-qPCR-driven despite its limits in detection and robustness. In this case, according to dPCR, the patient could have continued intermittent treatment and the stability of response was then confirmed by RT-qPCR. So, dPCR could be able to better identify peculiar clinical response to therapy.",2020,Increasing data suggest that digital PCR (dPCR) is more accurate and reliable than RT-qPCR in CML minimal residual disease monitoring and in patients' selection for treatment discontinuation.,"['chronic myeloid leukemia (CML) patients', 'Chronic Myeloid Leukemia Patients']","['RT-qPCR versus Digital PCR', 'digital PCR (dPCR']",['stability of molecular response'],"[{'cui': 'C0023473', 'cui_str': 'Chronic myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}]",,0.0378345,Increasing data suggest that digital PCR (dPCR) is more accurate and reliable than RT-qPCR in CML minimal residual disease monitoring and in patients' selection for treatment discontinuation.,"[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Zanaglio', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Bernardi', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gandolfi', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Farina', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Re', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Polverelli', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zollner', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Turra', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Morello', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Malagola', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Russo', 'Affiliation': 'Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, Department of Clinical and Experimental Sciences, University of Brescia, ASST Spedali Civili di Brescia, Brescia, Italy.'}]",Case reports in oncology,['10.1159/000510440']
2903,33250383,"Multi-session electrical neuromodulation effects on craving, relapse and cognitive functions in cocaine use disorder: A randomized, sham-controlled tDCS study.","BACKGROUND
The use of transcranial Direct Current Stimulation (tDCS) has previously shown promising results for reducing craving in cocaine use disorder. In this study we further explored the potential of tDCS as add-on intervention in the treatment of cocaine use disorder.
METHODS
In a randomized, placebo-controlled, between subject study, we applied tDCS bilaterally with the anodal electrode targeting the right dorsolateral prefrontal cortex (DLPFC; https://clinicaltrials.gov/ct2/show/NCT03025321). Patients with cocaine use disorder were allocated to ten sessions of either active tDCS (n = 29) or sham (n = 30) on five consecutive days. Inhibitory control and risky decision-making were measured via a Go-NoGo task and a two-choice gambling task, respectively, each at baseline, one day after all tDCS sessions and after three months. Relapse at follow-up and craving were also assessed.
RESULTS
There was no significant effect of active tDCS on the number of cocaine use days and craving. Relapse was frequent among patients who had received either active or sham tDCS (48.0 % and 69.2 %, respectively), despite an overall decrease in craving during the first two weeks of treatment. No effects were found on cognitive functions. An exploratory analysis for crack cocaine use only revealed that relapse rates were significantly reduced after active tDCS (n = 17) as compared to sham (n = 19).
CONCLUSIONS
No beneficial effects of tDCS on number of cocaine use days, craving and cognitive functions were found in the present study, but somewhat promising results were obtained regarding relapse rates among crack-cocaine users specifically. Further research is required to determine the efficacy of tDCS as a complementary treatment in cocaine use disorder.",2020,"No beneficial effects of tDCS on number of cocaine use days, craving and cognitive functions were found in the present study, but somewhat promising results were obtained regarding relapse rates among crack-cocaine users specifically.","['cocaine use disorder', 'Patients with cocaine use disorder']","['placebo', 'active or sham tDCS', 'active tDCS', 'tDCS', 'transcranial Direct Current Stimulation (tDCS']","['cognitive functions', 'craving, relapse and cognitive functions', 'craving', 'relapse rates', 'number of cocaine use days and craving', 'number of cocaine use days, craving and cognitive functions', 'Relapse']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0346528,"No beneficial effects of tDCS on number of cocaine use days, craving and cognitive functions were found in the present study, but somewhat promising results were obtained regarding relapse rates among crack-cocaine users specifically.","[{'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Verveer', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands. Electronic address: verveer@essb.eur.nl.'}, {'ForeName': 'Frederik M', 'Initials': 'FM', 'LastName': 'van der Veen', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Shahbabaie', 'Affiliation': 'Cognitive Psychology Unit, Institute of Psychology, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Remmerswaal', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ingmar H A', 'Initials': 'IHA', 'LastName': 'Franken', 'Affiliation': 'Department of Psychology, Education and Child Studies, Erasmus School of Social and Behavioural Sciences, Erasmus University, Rotterdam, the Netherlands.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108429']
2904,33250380,Neural activation during anticipation of monetary gain or loss does not associate with positive subjective response to alcohol in binge drinkers.,"BACKGROUND
Alcohol use disorder (AUD) remains an unresolved source of morbidity and mortality. Psychopharmacological challenge studies and neuroimaging experiments are two methods used to identify risk of problematic substance use. The present study combined these two approaches by examining associations between self-reported stimulation, sedation, liking or wanting more after a dose of alcohol and neural-based responses to anticipation of monetary gain and loss.
METHODS
Young adult binge drinkers (N = 56) aged 21-29, with no history of Substance Use Disorder completed five experimental sessions. These included four laboratory sessions in which they rated their subjective responses to alcohol (0.8 g/kg for men, 0.68 g/kg for women) or placebo, and a single functional magnetic resonance imaging session in which they completed a monetary incentive delay task. During the scan, we recorded neural signal related to anticipation of winning $5 or $1.50 compared to winning no money (WinMoney-WinZero), losing $5 or $1.50 compared to losing no money (LoseMoney-LoseZero), and winning $5 or $1.50 compared to losing $5 or $1.50 (WinMoney-LoseMoney), in reward related regions.
RESULTS
There were no significant associations between subjective ratings of ""Feel Drug Effect"", ""Like Drug Effect"", ""Want More"", stimulation or sedation following the acute alcohol challenge and neural activation in reward related regions during anticipation of monetary gain or loss.
CONCLUSIONS
These results suggest that sensitivity of neural reward circuits is not directly related to rewarding subjective experiences from alcohol. Taken together with previous studies, the present findings indicate that the association between the subjective effects of drugs and reward-related brain activity depends on the drugs, tasks or subject samples under study.",2020,"There were no significant associations between subjective ratings of ""Feel Drug Effect"", ""Like Drug Effect"", ""Want More"", stimulation or sedation following the acute alcohol challenge and neural activation in reward related regions during anticipation of monetary gain or loss.
","['0.8 g/kg for men, 0.68 g/kg for women) or', 'Young adult binge drinkers (N = 56) aged 21-29, with no history of Substance Use Disorder completed five experimental sessions', 'binge drinkers']","['alcohol', 'placebo']","['subjective ratings of ""Feel Drug Effect"", ""Like Drug Effect"", ""Want More"", stimulation or sedation']","[{'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517473', 'cui_str': '0.68'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0728866', 'cui_str': 'drug effects'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]",56.0,0.0543826,"There were no significant associations between subjective ratings of ""Feel Drug Effect"", ""Like Drug Effect"", ""Want More"", stimulation or sedation following the acute alcohol challenge and neural activation in reward related regions during anticipation of monetary gain or loss.
","[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Avenue, Chicago, IL, 60637, USA. Electronic address: epabon@uchicago.edu.'}, {'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Radoman', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychology, University of Kentucky, 171 Funkhouser Drive, Lexington, KY, 40506, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, 50 N Medical Drive, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Luan Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841 S Maryland Avenue, Chicago, IL, 60637, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108432']
2905,33250365,"Don't turn a blind eye to the Decree of November 14, 2018 in the French Journal Officiel.",,2020,,[],[],[],[],[],[],,0.0488396,,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vincent', 'Affiliation': ""Secrétaire général de l'Association Française d'Otologie et d'Otoneurologie, France. Electronic address: otologie@chru-lille.fr.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Couloigner', 'Affiliation': ""Secrétaire général de la Société Française d'ORL, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lescanne', 'Affiliation': ""Président du Collège ORL, collège Français d'ORL, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Thai-Van', 'Affiliation': ""Président de la Société Française d'Audiologie, France.""}]","European annals of otorhinolaryngology, head and neck diseases",['10.1016/j.anorl.2020.11.001']
2906,33250357,CTSim: Changing teaching practice in radiography with simulation.,"INTRODUCTION
Simulation offers radiography students the possibility to experiment with Computed Tomography (CT) in a way not possible in clinical practice. The aim of this work was to test a newly developed simulator 'CTSim' for effectiveness in teaching and learning.
METHODS
The simulator was tested in two phases. The first phase used a test-retest methodology with two groups, a group that experienced a Simulation based learning intervention and one which did not. The second phase subsequently tested for changes when the same intervention was introduced as part of an existing CT training module.
RESULTS
Phase 1 demonstrated statistically significant improvement of mean scores from 58% to 68% (P < .05) for students who experienced the intervention against no change in scores for the control group. Phase 2 saw mean scores improve statistically significantly in a teaching module from 66% to 73% (P < .05) following the application of the intervention as an active learning component.
CONCLUSION
The use of the CTSim simulator had a demonstrable effect on student learning when used as an active learning component in CT teaching.
IMPLICATIONS FOR PRACTICE
Simulation tools have a place in enhancing teaching and learning in terms of effectiveness and also introduce variety in the medium by which this is done.",2020,"Phase 2 saw mean scores improve statistically significantly in a teaching module from 66% to 73% (P < .05) following the application of the intervention as an active learning component.
",[],"['CTSim', 'CTSim simulator', 'Computed Tomography (CT', 'Simulation based learning intervention']",['mean scores'],[],"[{'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0173175,"Phase 2 saw mean scores improve statistically significantly in a teaching module from 66% to 73% (P < .05) following the application of the intervention as an active learning component.
","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stowe', 'Affiliation': 'Radiography and Diagnostic Imaging, School of Medicine, University College Dublin, Dublin, Ireland. Electronic address: john.stowe@ucd.ie.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'O Halloran', 'Affiliation': 'Radiography and Diagnostic Imaging, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Photopoulos', 'Affiliation': 'Radiological Technology Program, School of Health Sciences, Faculty of Health, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Lia', 'Affiliation': 'Department of Life Sciences and Health, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Quinn', 'Affiliation': 'Radiography and Diagnostic Imaging, School of Medicine, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Tschan', 'Affiliation': 'Haute École de Santé Vaud, University of Applied Sciences and Arts Western Switzerland, Lausanne, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Verwoolde', 'Affiliation': 'Department of Medical Imaging and Radiation Therapy, Hanze University of Applied, Sciences, Groningen, Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buissink', 'Affiliation': 'Department of Medical Imaging and Radiation Therapy, Hanze University of Applied, Sciences, Groningen, Netherlands.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2020.10.017']
2907,33250338,Slowed Processing Speed Disrupts Patient Expectancy in Late Life Depression.,"OBJECTIVE
Slowed processing speed and executive dysfunction are associated with poor outcomes in Late Life Depression (LLD), though it is unclear why. We investigated whether these variables interfere with the development of positive treatment expectancies in an antidepressant trial.
METHODS
Depressed older subjects were randomized to Open (intended to increase patient expectancy) or Placebo-controlled (termed 'Hidden,' intended to decrease expectancy) administration of antidepressant medication for 8 weeks. Analysis of covariance analyzed the between-group difference on expectancy (Credibility and Expectancy Scale [CES]) and depression (Hamilton Rating Scale for Depression [HRSD], Clinical Global Impressions [CGI] Severity). Moderator analyses examined whether these Open versus Hidden differences varied based on higher versus lower processing speed and executive function.
RESULTS
Among the 108 participants, a significant between-group difference was observed on expectancy (effect size [ES, Cohen's d] = 0.51 on CES Item 2; ES = 0.64 on Item 4), indicating the manipulation was effective. Processing speed as measured by the Stroop Color-Word Test (number color-words named in congruent condition) was a significant moderator of the Open versus Hidden effect on expectancy. Depressive symptom improvement was greater on average for Open versus Hidden participants who received active drug (CGI-severity ES = 1.25, HRSD ES = 0.41), but no neurocognitive moderators of the between-group difference reached statistical significance.
CONCLUSIONS
Slowed processing speed impairs the development of expectancies in antidepressant trials for LLD, which may help explain lower antidepressant response among older adults. Future studies may address whether interventions to optimize treatment expectancies are capable of improving treatment outcomes.",2020,"Depressive symptom improvement was greater on average for Open versus Hidden participants who received active drug (CGI-severity ES = 1.25, HRSD ES = 0.41), but no neurocognitive moderators of the between-group difference reached statistical significance.
","['Late Life Depression (LLD', 'older adults', 'Depressed older subjects']","[""Placebo-controlled (termed 'Hidden,' intended to decrease expectancy) administration of antidepressant medication""]","['Depressive symptom improvement', 'expectancy (Credibility and Expectancy Scale [CES]) and depression (Hamilton Rating Scale for Depression [HRSD], Clinical Global Impressions [CGI] Severity']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205262', 'cui_str': 'Occult'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",108.0,0.0407569,"Depressive symptom improvement was greater on average for Open versus Hidden participants who received active drug (CGI-severity ES = 1.25, HRSD ES = 0.41), but no neurocognitive moderators of the between-group difference reached statistical significance.
","[{'ForeName': 'Bret R', 'Initials': 'BR', 'LastName': 'Rutherford', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons (BRR, BM, PJB, AB, MMW, SPR), New York State Psychiatric Institute, New York, NY. Electronic address: brr8@cumc.columbia.edu.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'New York State Psychiatric Institute (CJC, JC XH, KB), New York, NY.'}, {'ForeName': 'Jongwoo', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'New York State Psychiatric Institute (CJC, JC XH, KB), New York, NY.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Mass', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons (BRR, BM, PJB, AB, MMW, SPR), New York State Psychiatric Institute, New York, NY.'}, {'ForeName': 'Xiaofu', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'New York State Psychiatric Institute (CJC, JC XH, KB), New York, NY.'}, {'ForeName': 'Kaleigh', 'Initials': 'K', 'LastName': ""O'Boyle"", 'Affiliation': 'New York State Psychiatric Institute (CJC, JC XH, KB), New York, NY.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Sneed', 'Affiliation': 'Queens College of the City University of New York (JS), New York, NY.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Brown', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons (BRR, BM, PJB, AB, MMW, SPR), New York State Psychiatric Institute, New York, NY.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brickman', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons (BRR, BM, PJB, AB, MMW, SPR), New York State Psychiatric Institute, New York, NY.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons (BRR, BM, PJB, AB, MMW, SPR), New York State Psychiatric Institute, New York, NY.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Roose', 'Affiliation': 'Columbia University Vagelos College of Physicians and Surgeons (BRR, BM, PJB, AB, MMW, SPR), New York State Psychiatric Institute, New York, NY.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.11.001']
2908,33250314,"Oligopin® Supplementation Mitigates Oxidative Stress in Postmenopausal Women with Osteopenia: A Randomized, Double-blind, Placebo-Controlled Trial.","BACKGROUND
Evidence indicates a close association between oxidative stress and the etiopathogenesis of osteopenia. In vitro and animal studies report that Oligopin®, an extract of French maritime pine bark extract, has beneficial effects on oxidative stress.
PURPOSE
Here, we aimed to determine whether supplementation with Oligopin® affects bone turnover markers, antioxidant enzymes, and oxidative stress markers in these patients.
METHODS
Forty-three postmenopausal women with osteopenia were randomized in a placebo-controlled, double-blind clinical trial to receive either 150 mg/day Oligopin® (n = 22) or placebo (n = 21) for 12 weeks. Plasma levels of bone turnover markers; osteocalcin (OC), type I collagen cross-linked C-telopeptide (CTX-1), OC/CTX1 ratio along with total antioxidant capacity(TAC), malondialdehyde (MDA) concentration, protein carbonyl, and total thiol contents in plasma, activities of manganese superoxide dismutase (MnSOD) and catalase in both peripheral blood mononuclear cells (PBMCs) and plasma as well as mRNA expression of MnSOD, catalase, and Nrf2 in PBMCs were measured at the baseline and the end of the intervention.
RESULTS
Oligopin® supplementation significantly increased OC levels and the ratio of OC to CTX1 in women with osteopenia compared to placebo intervention after 12 weeks. Oligopin® significantly decreased plasma protein carbonyl content in postmenopausal women compared with the after placebo treatment. Moreover, Oligopin® intervention significantly increased plasma total thiol content, TAC, plasma activity of both MnSOD and catalase, and the transcript level of Nrf2, MnSOD, and catalase in comparison with the placebo group.
CONCLUSION
Supplementation with 150 mg/day Oligopin® for 12 weeks exerts beneficial effects in postmenopausal osteopenia through improving the antioxidant defense system in the plasma and PBMCs that was accompanied by an increase in indicators of bone turnover.",2020,"Moreover, Oligopin® intervention significantly increased plasma total thiol content, TAC, plasma activity of both MnSOD and catalase, and the transcript level of Nrf2, MnSOD, and catalase in comparison with the placebo group.
","['postmenopausal women', 'Forty-three postmenopausal women with osteopenia', 'Postmenopausal Women with Osteopenia']","['placebo', 'Oligopin® supplementation', 'Oligopin® intervention', 'Oligopin® Supplementation', '150 mg/day Oligopin®', 'Placebo', 'Oligopin®', 'Supplementation with 150 mg/day Oligopin®']","['OC levels', 'bone turnover markers, antioxidant enzymes, and oxidative stress markers', 'plasma total thiol content, TAC, plasma activity of both MnSOD and catalase, and the transcript level of Nrf2, MnSOD, and catalase', 'Plasma levels of bone turnover markers; osteocalcin (OC), type I collagen cross-linked C-telopeptide (CTX-1), OC/CTX1 ratio along with total antioxidant capacity(TAC), malondialdehyde (MDA) concentration, protein carbonyl, and total thiol contents in plasma, activities of manganese superoxide dismutase (MnSOD) and catalase in both peripheral blood mononuclear cells (PBMCs) and plasma as well as mRNA expression of MnSOD, catalase, and Nrf2 in PBMCs', 'plasma protein carbonyl content']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850608', 'cui_str': 'Oligopin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0024708', 'cui_str': 'Manganese Superoxide Dismutase'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C1565078', 'cui_str': 'NFE2L2 protein, human'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}]",43.0,0.405467,"Moreover, Oligopin® intervention significantly increased plasma total thiol content, TAC, plasma activity of both MnSOD and catalase, and the transcript level of Nrf2, MnSOD, and catalase in comparison with the placebo group.
","[{'ForeName': 'Ziba', 'Initials': 'Z', 'LastName': 'Majidi', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zhila', 'Initials': 'Z', 'LastName': 'Maghbooli', 'Affiliation': 'MS Research Center, Neurosciences Institute of Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Ghasemi', 'Affiliation': 'Department of Obstetrics and Gynecology, Akbar Abadi Teaching Hospital, Iran University of Medical Sciences and Health Services, Tehran, Iran.'}, {'ForeName': 'Shadi Sadat Seyyed', 'Initials': 'SSS', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Hossein-Nezhad', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Nutrition, and Diabetes, Vitamin D, Skin and Bone Research Laboratory, Boston University Medical Center, Boston, Massachusetts, United States of America. Electronic address: arash_hsi@yahoo.com.'}, {'ForeName': 'Solaleh', 'Initials': 'S', 'LastName': 'Emamgholipour', 'Affiliation': 'Department of Clinical Biochemistry, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: semamgholipour@sina.tums.ac.ir.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153417']
2909,32857988,Pharmacotherapy for pulmonary arterial hypertension.,,2020,,['pulmonary arterial hypertension'],['Pharmacotherapy'],[],"[{'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.0218436,,"[{'ForeName': 'Talha Khan', 'Initials': 'TK', 'LastName': 'Burki', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30394-5']
2910,32815559,Follicular Lymphoma Evaluation Index (FLEX): A new clinical prognostic model that is superior to existing risk scores for predicting progression-free survival and early treatment failure after frontline immunochemotherapy.,"Patients with advanced-stage follicular lymphoma (FL) who progress early after receiving first-line therapy have poor overall survival (OS). Currently applied clinical prognostic models such as FL International Prognostic Index [FLIPI], FLIPI-2 and PRIMA-Prognostic Index [PRIMA-PI] have suboptimal sensitivity and specificity to predict this poor prognosis subgroup. The primary objective was to develop a novel prognostic model, the FL Evaluation Index (FLEX) score, to identify high-risk patients and compare its performance with FLIPI, FLIPI-2 and PRIMA-PI. Progression-free survival (PFS) after first-line immunochemotherapy was the key endpoint, while OS and progression of disease within 24 months (POD24) were also assessed. The model, which includes nine clinical variables, was developed using a cohort of patients with previously untreated advanced-stage FL from the phase 3 GALLIUM trial (NCT01332968). The performance of the model was validated using data from the SABRINA trial (NCT01200758). In GALLIUM (n = 1004; 127 with and 877 without POD24), FLEX increased the intergroup (low-risk/high-risk) difference in 2-year and 3-year PFS rates and demonstrated superior intergroup differences in 2-year and 3-year OS rates compared with FLIPI, FLIPI-2 and PRIMA-PI. Sensitivity for a high-risk score to predict POD24 was 60% using FLEX compared with 53% for FLIPI and FLIPI-2, and 69% for PRIMA-PI, while specificity was 68% for FLEX compared with 58% for FLIPI, 59% for FLIPI-2 and 48% for PRIMA-PI. The prognostic value of FLEX in SABRINA was similar to FLIPI. Therefore, FLEX appears to perform better than existing prognostic models in previously untreated FL, in particular for the newer treatment regimens.",2020,"Sensitivity for a high-risk score to predict POD24 was 60% using FLEX compared with 53% for FLIPI and FLIPI-2, and 69% for PRIMA-PI, while specificity was 68% for FLEX compared with 58% for FLIPI, 59% for FLIPI-2 and 48% for PRIMA-PI.",['Patients with advanced-stage follicular lymphoma (FL'],"['FLEX', 'frontline immunochemotherapy']","['Follicular Lymphoma Evaluation Index (FLEX', 'Progression-free survival (PFS', 'overall survival (OS', 'FL International Prognostic Index', 'novel prognostic model, the FL Evaluation Index (FLEX) score, to identify high-risk patients and compare its performance with FLIPI, FLIPI-2 and PRIMA-PI', '2-year and 3-year OS rates', '2-year and 3-year PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]","[{'cui': 'C0015193', 'cui_str': 'Evaluation Indexes'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}]","[{'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0015193', 'cui_str': 'Evaluation Indexes'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4040298', 'cui_str': 'Follicular Lymphoma International Prognostic Index'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",1004.0,0.0726308,"Sensitivity for a high-risk score to predict POD24 was 60% using FLEX compared with 53% for FLIPI and FLIPI-2, and 69% for PRIMA-PI, while specificity was 68% for FLEX compared with 58% for FLIPI, 59% for FLIPI-2 and 48% for PRIMA-PI.","[{'ForeName': 'Farheen', 'Initials': 'F', 'LastName': 'Mir', 'Affiliation': 'The Royal Marsden NHS Trust Foundation, London, UK.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mattiello', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Grigg', 'Affiliation': 'Austin Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Herold', 'Affiliation': 'HELIOS-Klinikum Erfurt, Erfurt, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'University Hospital Munich, Munich, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Marcus', 'Affiliation': 'HCA Healthcare, London, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Peter MacCallum Cancer Centre, Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bolen', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Knapp', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Nielsen', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Casulo', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester, New York, New York, USA.'}]",American journal of hematology,['10.1002/ajh.25973']
2911,32804408,Daratumumab-lenalidomide-dexamethasone vs standard-of-care regimens: Efficacy in transplant-ineligible untreated myeloma.,"Daratumumab in combination with lenalidomide-dexamethasone (D-Rd) recently received FDA approval for the treatment of transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM). The present PEGASUS study compared progression-free survival (PFS) in patients treated with D-Rd in the MAIA trial and patients treated with common standard-of-care regimens from the Flatiron Health electronic health record-derived deidentified database, which has data from patients treated primarily at community-based oncology practices in the United States. Individual-level patient data from both data sources were used to perform an anchored indirect treatment comparison (ITC) of D-Rd to bortezomib-lenalidomide-dexamethasone (VRd) and bortezomib-dexamethasone (Vd); lenalidomide-dexamethasone (Rd) was the common anchor for the ITC. Hazard ratios (HRs) reflecting direct comparisons of PFS within MAIA (D-Rd vs Rd) and Flatiron Health (VRd vs Rd; Vd vs Rd) were used to make ITCs for D-Rd vs VRd and Vd, respectively. After application of MAIA inclusion/exclusion criteria and propensity-score weighting, the Flatiron Health patients resembled the MAIA trial population on measured baseline characteristics. Based on the direct comparison within MAIA, treatment with D-Rd was associated with a significantly lower risk of progression or death compared to Rd (HR 0.54; 95% CI 0.42, 0.71). Based on the ITCs, D-Rd was associated with a significantly lower risk of progression or death compared to VRd (HR 0.68; 95% CI 0.48, 0.98) and Vd (HR 0.48; 95% CI 0.33, 0.69). In the absence of head-to-head trials comparing D-Rd to VRd or Vd, the present ITC may help inform treatment selection in transplant-ineligible patients with NDMM.",2020,"Based on the ITCs, D-Rd was associated with a significantly lower risk of progression or death compared to VRd (HR 0.68; 95% CI 0.48, 0.98) and Vd (HR 0.48; 95% CI 0.33, 0.69).","['transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM', 'patients treated with D-Rd in the MAIA trial and patients treated with common standard-of-care regimens from the Flatiron Health electronic health record-derived deidentified database, which has data from patients treated primarily at community-based oncology practices in the United States', 'transplant-ineligible patients with NDMM', 'transplant-ineligible untreated myeloma']","['lenalidomide-dexamethasone (D-Rd', 'Daratumumab-lenalidomide-dexamethasone vs standard-of-care regimens', 'bortezomib-lenalidomide-dexamethasone (VRd) and bortezomib-dexamethasone (Vd); lenalidomide-dexamethasone (Rd']","['risk of progression or death', 'Hazard ratios (HRs) reflecting direct comparisons of PFS within MAIA (D-Rd vs Rd) and Flatiron Health', 'progression-free survival (PFS']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0746966,"Based on the ITCs, D-Rd was associated with a significantly lower risk of progression or death compared to VRd (HR 0.68; 95% CI 0.48, 0.98) and Vd (HR 0.48; 95% CI 0.33, 0.69).","[{'ForeName': 'Brian G M', 'Initials': 'BGM', 'LastName': 'Durie', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Atrium Health, Charlotte, North Carolina, USA.'}, {'ForeName': 'Bareng A S', 'Initials': 'BAS', 'LastName': 'Nonyane', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Ammann', 'Affiliation': 'Janssen Scientific Affairs, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Lam', 'Affiliation': 'Janssen Global Services, Raritan, New Jersey, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, Raritan, New Jersey, USA.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Maiese', 'Affiliation': 'Janssen Scientific Affairs, Horsham, Pennsylvania, USA.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Facon', 'Affiliation': 'Department of Haematology, Lille University Hospital, Lille, France.'}]",American journal of hematology,['10.1002/ajh.25963']
2912,32711750,Effects of Neonatal Hyperglycemia on Retinopathy of Prematurity and Visual Outcomes at 7 Years of Age: A Matched Cohort Study.,"OBJECTIVE
To determine whether neonatal hyperglycemia is associated with retinopathy of prematurity (ROP), visual outcomes, and ocular growth at 7 years of age.
STUDY DESIGN
Children born preterm (<30 weeks of gestational age) at a tertiary hospital in Auckland, New Zealand, who developed neonatal hyperglycemia (2 blood glucose concentrations ≥153 mg/dL [8.5 mmol/L] 4 hours apart) were matched with children who were not hyperglycemic (matching criteria: sex, gestational age, birth weight, age, socioeconomic status, and multiple birth) and assessed at 7 years of corrected age. The primary outcome, favorable overall visual outcome (visual acuity ≤0.3 logarithm of the minimum angle of resolution, no strabismus, stereoacuity ≤240 arcsec, not requiring spectacles) was compared between groups using generalized matching criteria-adjusted linear regression models.
RESULTS
Assessments were performed on 57 children with neonatal hyperglycemia (hyperglycemia group) and 54 matched children without hyperglycemia (control group). There were no differences in overall favorable visual outcome (OR 0.95, 95% CI 0.42-2.13, P = .90) or severe ROP incidence (OR 2.20, 95% CI 0.63-7.63, P = .21) between groups. Children with hyperglycemia had poorer binocular distance visual acuity (mean difference 0.08, 95% CI 0.03-0.14 logarithm of the minimum angle of resolution, P < .01), more strabismus (OR 6.22, 95% CI 1.31-29.45, P = .02), and thicker crystalline lens (mean difference 0.14, 95% CI 0.04-0.24 mm, P < .01). Maximum blood glucose concentration was greater in the ROP-treated group compared with the ROP-not treated and no ROP groups after adjusting for sex, gestational age, and birth weight z score (P = .02).
CONCLUSIONS
Neonatal hyperglycemia was not associated with overall visual outcomes at 7 years of age. However, there were between-group differences for specific outcome measures relating to interocular lens growth and binocular vision. Further follow-up is required to determine implications on long-term visual outcome.",2020,"Maximum blood glucose concentration was greater in the ROP-treated group compared with the ROP-not treated and no ROP groups after adjusting for sex, gestational age, and birth weight z score (P = .02).
","['7\xa0Years of Age', 'children who were not hyperglycemic (matching criteria: sex, gestational age, birth weight, age, socioeconomic status, and multiple birth) and assessed at 7\xa0years of corrected age', '30\xa0weeks of gestational age) at a tertiary hospital in Auckland, New Zealand, who developed neonatal hyperglycemia ', 'Children born preterm ', '57 children with neonatal hyperglycemia (hyperglycemia group) and 54 matched children without hyperglycemia (control group']","['dL', 'Neonatal Hyperglycemia']","['overall visual outcomes', 'thicker crystalline lens', 'favorable overall visual outcome (visual acuity ≤0.3 logarithm of the minimum angle of resolution, no strabismus, stereoacuity ≤240 arcsec, not requiring spectacles', 'overall favorable visual outcome', 'interocular lens growth and binocular vision', 'binocular distance visual acuity', 'Retinopathy of Prematurity and Visual Outcomes', 'strabismus', 'birth weight z score', 'Maximum blood glucose concentration', 'severe ROP incidence']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0026753', 'cui_str': 'Multiple Births'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0475718', 'cui_str': 'Neonatal hyperglycemia'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0475718', 'cui_str': 'Neonatal hyperglycemia'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0038379', 'cui_str': 'Strabismus'}, {'cui': 'C1275505', 'cui_str': 'Stereoscopic acuity'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0042794', 'cui_str': 'Binocular vision observable'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",57.0,0.254542,"Maximum blood glucose concentration was greater in the ROP-treated group compared with the ROP-not treated and no ROP groups after adjusting for sex, gestational age, and birth weight z score (P = .02).
","[{'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Leung', 'Affiliation': 'School of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand; Department of Optometry and Vision Science, University of Canberra, Canberra, Australia.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'School of Optometry and Vision Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Frank H', 'Initials': 'FH', 'LastName': 'Bloomfield', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Greg D', 'Initials': 'GD', 'LastName': 'Gamble', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Harding', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Poppe', 'Affiliation': 'School of Optometry and Vision Science, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Thompson', 'Affiliation': 'School of Optometry and Vision Science, University of Auckland, Auckland, New Zealand; School of Optometry and Vision Science, University of Waterloo, Ontario, Canada.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Tottman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Trecia A', 'Initials': 'TA', 'LastName': 'Wouldes', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Alsweiler', 'Affiliation': ""Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand; Newborn Services, National Women's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.059']
2913,33002009,Acupuncture decreased the risk of stroke among patients with fibromyalgia in Taiwan: A nationwide matched cohort study.,"BACKGROUND
The aim of this study was to investigate the effectiveness of acupuncture in decreasing the risk of stroke in patients with fibromyalgia.
METHODS
We enrolled patients who was newly diagnosed as having fibromyalgia between 1 January, 2000 and 31 December, 2010 from the Taiwanese National Health Insurance Research Database. The claim data for both the acupuncture cohort and non-acupuncture cohort were assessed from the index date to 31 December, 2013. A Cox regression model adjusted for age, sex, comorbidities, and drugs use was used to compare the hazard ratios of the two cohorts. The cumulative incidence of stroke was estimated by using the Kaplan-Meier method.
RESULTS
After performing a propensity score matching with a 1:1 ratio, there were 65,487 patients in the acupuncture and non-acupuncture cohorts with similar distributions in the baseline characteristics. The cumulative incidence of stroke was significantly lower in the acupuncture cohort (log-rank test, p < 0.001). In the follow-up period, 4,216 patients in the acupuncture cohort (11.01 per 1000 person-years) and 6,849 patients in the non-acupuncture cohort (19.82 per 1000 person-years) suffered from stroke (adjusted HR 0.53, 95% CI 0.51-0.55). Acupuncture favorably affected the incidence of stroke regardless of the patient's age, sex, comorbidities, and conventional drug use.
CONCLUSIONS
Our study found that acupuncture might have a beneficial effect on reducing the risk of stroke in patients with fibromyalgia in Taiwan. Additional clinical and basic science studies are warranted.",2020,"The cumulative incidence of stroke was significantly lower in the acupuncture cohort (log-rank test, p < 0.001).","['patients with fibromyalgia in Taiwan', '65,487 patients in the', 'patients with fibromyalgia', 'enrolled patients who was newly diagnosed as having fibromyalgia between 1 January, 2000 and 31 December, 2010 from the Taiwanese National Health Insurance Research Database']","['acupuncture and non-acupuncture', 'Acupuncture', 'acupuncture']","['cumulative incidence of stroke', 'risk of stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",65487.0,0.228072,"The cumulative incidence of stroke was significantly lower in the acupuncture cohort (log-rank test, p < 0.001).","[{'ForeName': 'Ming-Cheng', 'Initials': 'MC', 'LastName': 'Huang', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hung-Rong', 'Initials': 'HR', 'LastName': 'Yen', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Cheng-Li', 'Initials': 'CL', 'LastName': 'Lin', 'Affiliation': 'Management Office of Health Data, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Mao-Feng', 'Initials': 'MF', 'LastName': 'Sun', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Mei-Yao', 'Initials': 'MY', 'LastName': 'Wu', 'Affiliation': 'Department of Chinese Medicine, China Medical University Hospital, Taichung, Taiwan.'}]",PloS one,['10.1371/journal.pone.0239703']
2914,32945013,Severe infusion-related reaction to crizanlizumab in an adolescent with sickle cell disease.,,2020,,['adolescent with sickle cell disease'],['crizanlizumab'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]",[],[],,0.0160446,,"[{'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Karkoska', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Quinn', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Clapp', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Patrick T', 'Initials': 'PT', 'LastName': 'McGann', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}]",American journal of hematology,['10.1002/ajh.26002']
2915,33257495,Randomised controlled trial of integrated trauma-focused psychotherapy for traumatic stress and substance use among adolescents: trial protocol.,"INTRODUCTION
Post-traumatic stress disorder (PTSD) and substance use disorder frequently co-occur and tend to have their onset during adolescence. Although research has highlighted the importance of treating these disorders in an integrated fashion, there is a dearth of empirically validated integrated treatment options for adolescents with this comorbidity. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents (Concurrent Treatment of PTSD and Substance Use Using Prolonged Exposure - Adolescent (COPE-A)), relative to a supportive counselling control condition (Person-Centred Therapy (PCT)).
METHODS AND ANALYSIS
A two-arm, parallel, single-blind RCT with blinded follow-up at 4 and 12 months poststudy entry will be conducted in Sydney, Australia. Participants (n~100 adolescents aged 12-18 years) and their caregivers (caregiver participation is optional) will be allocated to undergo either COPE-A or PCT (allocation ratio 1:1) using minimisation. Both therapies will be delivered individually by project psychologists over a maximum of 16 sessions of 60-90 min duration and will include provision of up to four 30 min optional caregiver sessions. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for DSM-5.
ETHICS AND DISSEMINATION
Ethical approval has been obtained from the human research ethics committees of the Sydney Children's Hospital Network (HREC/17/SCHN/306) and the University of Sydney (HREC 2018/863). Findings will be published in peer-reviewed journals and presented at scientific conferences.
TRIAL REGISTRATION NUMBER
ACTRN12618000785202; Pre-reults.
PROTOCOL VERSION
Version 1, 31 July 2017.",2020,"Using Prolonged Exposure - Adolescent (COPE-A)), relative to a supportive counselling control condition (Person-Centred Therapy (PCT)).
","['adolescents with this comorbidity', 'adolescents', 'adolescents (Concurrent Treatment of PTSD and Substance Use', 'VERSION\n\n\nVersion 1, 31 July 2017', 'Participants (n~100 adolescents aged 12-18 years) and their caregivers (caregiver participation is optional']","['integrated trauma-focused cognitive-behavioural treatment', 'COPE-A or PCT (allocation ratio 1:1) using minimisation', 'supportive counselling control condition (Person-Centred Therapy (PCT', 'integrated trauma-focused psychotherapy']","['severity of PTSD symptoms', 'Clinician-Administered PTSD Scale']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.134904,"Using Prolonged Exposure - Adolescent (COPE-A)), relative to a supportive counselling control condition (Person-Centred Therapy (PCT)).
","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Mills', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia katherine.mills@sydney.edu.au.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Barrett', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Cobham', 'Affiliation': 'School of Psychology, The University of Queensland, Saint Lucia, Queensland, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Parkville, Victoria, Australia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Perrin', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': 'National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Peach', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Kihas', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cassar', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Schollar-Root', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-043742']
2916,33257489,Multicentre randomised phase II study of the perioperative administration of flurbiprofen axetil in patients with non-small cell lung cancer: study protocol of the FLAX Study.,"INTRODUCTION
In patients with non-small cell lung cancer, surgical treatment with postoperative adjuvant chemotherapy is performed. However, the improvement of overall survival achieved by postoperative adjuvant chemotherapy may be insufficient in consideration of the deterioration of quality of life (QOL). Considering the relationships among surgical treatments, inflammation and carcinogenesis, non-steroidal anti-inflammatory drugs (NSAIDs) are a candidate postoperative treatment for preventing recurrence and maintaining QOL. In this study, we investigate the effects of the perioperative administration of flurbiprofen axetil on postoperative recurrence in patients with non-small cell lung cancer.
METHODS AND ANALYSIS
This study is a multicentre, parallel group, open label, randomised controlled trial. Patients clinically suspected of non-small cell lung cancer are randomly assigned to the flurbiprofen axetil group or the no-NSAIDs group. A total of 420 patients (210 per group) will be registered. The primary analysis will evaluate the treatment effect of flurbiprofen axetil on postoperative recurrence.
ETHICS AND DISSEMINATION
The study protocol was approved by the Clinical Research Review Board of Saitama Medical University in September 2019 (No. 192002) and will be approved by each institutional review board of all participating institutions before patient enrolment. This study complies with the latest version of the Declaration of Helsinki, Clinical Trial Act and related notifications. Results will be published in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
Japan Registry of Clinical Trials (jRCTs031190167; Pre-results) (https://jrct.niph.go.jp/).",2020,Patients clinically suspected of non-small cell lung cancer are randomly assigned to the flurbiprofen axetil group or the no-NSAIDs group.,"['patients with non-small cell lung cancer', 'patients with non-small cell lung cancer, surgical treatment with', '420 patients (210 per group) will be registered', 'Patients clinically suspected of non-small cell lung cancer']","['flurbiprofen axetil', 'postoperative adjuvant chemotherapy']","['postoperative recurrence', 'quality of life (QOL', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}]","[{'cui': 'C1610514', 'cui_str': 'flurbiprofen axetil'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",420.0,0.218526,Patients clinically suspected of non-small cell lung cancer are randomly assigned to the flurbiprofen axetil group or the no-NSAIDs group.,"[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Sakamaki', 'Affiliation': 'Center for Data Science, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'General Thoracic Surgery, National Hospital Organisation Yokohama Medical Center, Yokohama, Japan watanabe.katsuya.gt@mail.hosp.go.jp.'}, {'ForeName': 'Tetsukan', 'Initials': 'T', 'LastName': 'Woo', 'Affiliation': 'Respiratory Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Munetaka', 'Initials': 'M', 'LastName': 'Masuda', 'Affiliation': 'Surgery, Yokohama City University, Yokohama, Japan.'}]",BMJ open,['10.1136/bmjopen-2020-040969']
2917,33257487,Evaluating the impact of a champion on implementation of the Back Skills Training (BeST) programme in Canada: a mixed methods feasibility study protocol.,"INTRODUCTION
There is global recognition that low back pain (LBP) should be managed with a biopsychosocial approach. Previous implementation of this approach resulted in low uptake and highlighted the need for ongoing support. This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation.
METHODS
A pragmatic cluster RCT with embedded qualitative study with physiotherapists treating LBP in publicly funded physiotherapy departments in Newfoundland and Labrador, Canada. Participants will complete a previously developed online training course to equip them to deliver a biopsychosocial intervention for LBP. Clusters randomised to the intervention arm will receive additional support from a champion. A minimum champion training package has been developed based on known barriers in the literature. This includes strategies to target barriers relating to group-based scheduling issues, lack of managerial support, perceived patient factors such as addressing patient expectations for other types of treatments or selecting which patients might be best suited for this intervention, and anxiety about delivering something new. This package will be further codeveloped with study champions based on identified implementation barriers using the Behaviour Change Wheel. Clusters will be monitored for 6 months to assess champion and physiotherapist recruitment and retention, acceptability and implementation of the champion training, and the viability of conducting a cluster RCT in this setting. A purposive sample of physiotherapists will be interviewed from both arms.
ETHICS AND DISSEMINATION
This study was approved by Newfoundland and Labrador Health Research Ethics Authority in December 2018. Results will be disseminated to academic audiences through conferences and peer reviewed publications; to all study participants, their clinical leads, and patients with LBP.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov Identifier: NCT04377529; Memorial University of Newfoundland Protocol Record 20190025; Pre-results.",2020,"This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation.
","['Canada', 'A pragmatic cluster RCT with embedded qualitative study with physiotherapists treating LBP in publicly funded physiotherapy departments in Newfoundland and Labrador, Canada']","['biopsychosocial intervention for LBP', 'Back Skills Training (BeST) programme']",[],"[{'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C1956182', 'cui_str': 'Newfoundland and Labrador'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]",[],,0.183606,"This study aims to explore the feasibility of (i) training and using a champion to support implementation, (ii) using a cluster randomised controlled trial (RCT), (iii) collecting patient reported outcome measures in a Canadian public healthcare setting and to identify contextual barriers to implementation.
","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': ""Primary Healthcare Research Unit, Memorial University of Newfoundland Faculty of Medicine, St. John's, Newfoundland and Labrador, Canada amanda.hall@med.mun.ca.""}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Richmond', 'Affiliation': ""Primary Healthcare Research Unit, Memorial University of Newfoundland Faculty of Medicine, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Krystal', 'Initials': 'K', 'LastName': 'Bursey', 'Affiliation': ""Primary Healthcare Research Unit, Memorial University of Newfoundland Faculty of Medicine, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Hansen', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Williamson', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Copsey', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Albury', 'Affiliation': 'Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Shabnam', 'Initials': 'S', 'LastName': 'Asghari', 'Affiliation': ""Primary Healthcare Research Unit, Memorial University of Newfoundland Faculty of Medicine, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Vernon', 'Initials': 'V', 'LastName': 'Curran', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pike', 'Affiliation': ""Primary Healthcare Research Unit, Memorial University of Newfoundland Faculty of Medicine, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Etchegary', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040834']
2918,33250396,Role of strengthening during nonoperative treatment of lateral epicondyle tendinopathy.,"INTRODUCTION
Lateral epicondyle tendinopathy (LET) is the most common cause of lateral elbow pain. The literature on rehabilitation of the condition encompasses a plethora of interventions with most current evidence indicating that stretches and some form of strengthening are vital components. However, patient outcomes are infrequently reported further than 12 weeks from the start of therapy and it is unclear which components of a home exercise program are necessary to alleviate symptoms up to one year from the initiation of a therapy program.
PURPOSE OF THE STUDY
The purpose of the study is to determine if a therapy program with 4 to 6 visits spaced out over 12 weeks focusing on self-management and strengthening is more effective in reducing pain and improving function long term than the same program without strengthening, for individuals with LET.
STUDY DESIGN
This is a randomized controlled trial.
METHODS
Ninety-four patients were randomly allocated into two groups: both groups received the interventions of education in pertinent pathoanatomy, stretching, pain management through rest and icing, and activity modification. Group 1 (n = 38) was also provided with a strengthening component to the home exercise program, whereas group 2 did not (n = 21). Our primary outcome measure was pain at rest and pain with activity; our secondary measure was the level of functional impairment as measured by the quick disabilities of arm shoulder and hand. Outcome measurements were assessed at baseline, 6, 12, 24, and 52 weeks after initiation of therapy.
RESULTS
Both groups demonstrated statistically significant improvement with a moderate to large effect size in pain and function scores when compared with previous time point at 6, 12, and 24 weeks. Pain continued to decrease for both groups from 24 weeks to 52 weeks, but interestingly, there was a significant increase with moderate effect size in the quick disabilities of arm shoulder and hand score at 52 weeks when compared with week 24. No statistically significant difference was found between the two groups at any time point up to 52 weeks from the start of therapy.
CONCLUSIONS
This study demonstrates that a therapy program consisting of a low number of visits spaced out over 12 weeks based on education, stretches, activity modification, and pain management techniques is effective at reducing pain and increasing function in patients with LET. The addition of strengthening to this program did not improve outcomes. The therapy approach used in this study is consistent with the International Classification of Function guidelines and focuses on engaging patients in self-management of the condition through patient education and self-empowerment.",2020,"No statistically significant difference was found between the two groups at any time point up to 52 weeks from the start of therapy.
","['individuals with LET', 'lateral epicondyle tendinopathy', 'patients with LET', 'Ninety-four patients']","['interventions of education in pertinent pathoanatomy, stretching, pain management through rest and icing, and activity modification', 'strengthening component to the home exercise program']","['pain and function scores', 'quick disabilities of arm shoulder and hand score', 'Pain', 'pain at rest and pain with activity', 'level of functional impairment as measured by the quick disabilities of arm shoulder and hand']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0222681', 'cui_str': 'Structure of epicondyle'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",94.0,0.0511868,"No statistically significant difference was found between the two groups at any time point up to 52 weeks from the start of therapy.
","[{'ForeName': 'Kathryn S', 'Initials': 'KS', 'LastName': 'McQueen', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Milliken Hand Rehabilitation Center, Saint Louis, MO, USA. Electronic address: Kmcqueen@wustl.edu.'}, {'ForeName': 'Rhonda K', 'Initials': 'RK', 'LastName': 'Powell', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Milliken Hand Rehabilitation Center, Saint Louis, MO, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Keener', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Milliken Hand Rehabilitation Center, Saint Louis, MO, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Whalley', 'Affiliation': 'Washington University School of Medicine, Program of Occupational Therapy, Saint Louis, MO, USA.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Calfee', 'Affiliation': 'Department of Orthopedic Surgery, Washington University School of Medicine, Saint Louis, MO, USA.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.10.009']
2919,33250388,Drainage on augmentation mammoplasty: Does it work?,"BACKGROUND
Breast prostheses could be associated with complications, despite many studies on surgical materials and techniques. The role of surgical drainage in preventing complications on breast prostheses surgery is controversial.
OBJECTIVES
This study aimed to evaluate the role and effectiveness of vacuum drainage in the augmentation mammoplasty.
METHODS
A prospective multicentric randomized comparative clinical trial was conducted with 150 patients, who were the candidates for breast augmentation. The candidates were split into two groups to analyze the breast drain role. Group1: closed-suction drainage; measurements were taken every 24 h for 48 h. Group2: control (no drainage); all the patients were submitted to a clinical and postoperative ultrasonography evaluation (7th day and 3rd month). The late consultations (1st-, 2nd-, and 3rd-year postoperative time) were carried out to identify any complication, such as infection, seroma, hematoma, asymmetry, hypertrophic scarring, rippling, implant position, visible edges, and sensibility alteration.
RESULTS
A total of 150 female patients were operated with 300 breast implants placed into subglandular pocket. In the first 24 h postoperative (D1), the drainage volume ranged from 12 ml to 210 ml (mean= 74.90 ml; SD= 43.29 ml). After 24 h, on the second day (D2), the collected volume ranged from 10 ml to 120 ml (mean= 44.76 ml; SD= 24.80 ml). The total drainage volume in the 48 h ranged from 22 ml to 320 ml (mean= 119.7 ml; SD= 62.20 ml). The breast ultrasonography series (BUSGS) analysis was done on the 7th day and 3rd month in both groups. There was no significant difference between G1 and G2 groups (p = 0.05 and 0.25, respectively). In the follow-up, some patients (33-44%) declared sensitivity disturbing on the nipple-areola complex (NAC) and lower breast segment.
CONCLUSIONS
The closed-suction breast drainage in breast augmentation was associated with high cost and time-consuming and not demonstrated any benefit in a recent postoperative time.",2020,"There was no significant difference between G1 and G2 groups (p = 0.05 and 0.25, respectively).","['150 patients, who were the candidates for breast augmentation', '150 female patients were operated with 300 breast implants placed into subglandular pocket', 'Group1']","['surgical drainage', 'vacuum drainage']","['total drainage volume', 'complication, such as infection, seroma, hematoma, asymmetry, hypertrophic scarring, rippling, implant position, visible edges, and sensibility alteration']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191925', 'cui_str': 'Augmentation mammoplasty'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0178391', 'cui_str': 'Insertion of prosthesis for breast'}, {'cui': 'C0332286', 'cui_str': 'Into'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities'}]",150.0,0.0343694,"There was no significant difference between G1 and G2 groups (p = 0.05 and 0.25, respectively).","[{'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Charles-de-Sá', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research State University Hospital of Rio de Janeiro - UERJ-RJ, av. Mal.Rondon, 381.São francisco Xavier. Rio de Janeiro. CEP: 20950-003, Brazil; Perfoma Clinic - Natal, Brazil; Pitanguy Institute, Rio de Janeiro, Brazil. Electronic address: clinicaperforma@uol.com.br.'}, {'ForeName': 'Natale Ferreira', 'Initials': 'NF', 'LastName': 'Gontijo-de-Amorim', 'Affiliation': 'Pitanguy Institute, Rio de Janeiro, Brazil; Perfoma Clinic - Rio de Janeiro, Brazil. Electronic address: natalefga@yahoo.com.br.'}, {'ForeName': 'Julia Klein', 'Initials': 'JK', 'LastName': 'Rossi', 'Affiliation': 'Department of Plastic Surgery of the Pitanguy Institute - Rio de Janeiro, Brazil. Electronic address: juliaklein@hotmail.com.'}, {'ForeName': 'Alexandre Malta da Costa', 'Initials': 'AMDC', 'LastName': 'Messeder', 'Affiliation': 'Radiology Department of State University of Rio de Janeiro, UERJ-RJ, Brazil. Electronic address: messederalexandre@gmail.com.'}, {'ForeName': 'Luciana Nogueira de Araujo', 'Initials': 'LNA', 'LastName': 'Jorge', 'Affiliation': 'Radiology Department of State University of Rio de Janeiro, UERJ-RJ, Brazil. Electronic address: lunogueira.aj@hotmail.com.'}, {'ForeName': 'Denise Salles Coelho', 'Initials': 'DSC', 'LastName': 'da Mota', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research State University Hospital of Rio de Janeiro - UERJ-RJ, av. Mal.Rondon, 381.São francisco Xavier. Rio de Janeiro. CEP: 20950-003, Brazil. Electronic address: denisedamota@hotmail.com.'}, {'ForeName': 'José Horácio', 'Initials': 'JH', 'LastName': 'Aboudib', 'Affiliation': 'Department of Plastic, Reconstructive and Aesthetic Surgery, Training and Research State University Hospital of Rio de Janeiro - UERJ-RJ, av. Mal.Rondon, 381.São francisco Xavier. Rio de Janeiro. CEP: 20950-003, Brazil. Electronic address: jhaboudib@gmail.com.'}]","Journal of plastic, reconstructive & aesthetic surgery : JPRAS",['10.1016/j.bjps.2020.10.059']
2920,33250386,"Abuse liability assessment of the JUUL system in two nicotine concentrations compared to combustible cigarette, nicotine gum and comparator electronic nicotine delivery system.","BACKGROUND
To assess the abuse liability of the JUUL System (JS) in 5.0 % (59 mg/mL) and 3.0 % (35 mg/mL) nicotine concentrations.
METHODS
Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years) were randomized to one of four study flavor arms and then to a within-subjects cross-over sequence for five test product categories: (1) JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS (VUSE Alto 5.0 % nicotine). Products were tested by ad libitum use (5 min for ENDS and cigarette; 30 min for gum); nicotine pharmacokinetic (PK) parameters and subjective effects were assessed following use.
RESULTS
Maximum plasma nicotine concentration (C max-BL ), rate of plasma nicotine rise and total nicotine exposure (AUC 0-60-BL ) of UB cigarette were significantly greater than all other test products. The comparator ENDS was significantly greater than 5.0 % and 3.0 % JS and nicotine gum on C max-BL , rate of plasma nicotine rise, and AUC 0-60-BL ; C max-BL of JS 5.0 % was significantly greater than JS 3.0 % and nicotine gum. Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures.
CONCLUSIONS
These results suggest that the abuse liability of both 5.0 % and 3.0 % JS is: (1) substantially lower than UB cigarette; (2) somewhat lower than comparator ENDS; and (3) higher than nicotine gum. Additionally, the abuse liability of JS 5.0 % is somewhat higher than JS 3.0 %.",2020,"Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures.
",['Adult smokers (N = 146; 45.9 % female; mean age = 41.29 years'],['JS 5.0 % nicotine concentration; (2) JS 3.0 % nicotine; (3) usual brand (UB) cigarette; (4) 4 mg mint nicotine gum; (5) comparator ENDS '],"['Product liking and satisfying effects', 'C max-BL , rate of plasma nicotine rise, and AUC 0-60-BL ; C max-BL of JS', 'abuse liability', 'Maximum plasma nicotine concentration (C max-BL ), rate of plasma nicotine rise and total nicotine exposure (AUC 0-60-BL ) of UB cigarette']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0452249', 'cui_str': 'Mint'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0444930', 'cui_str': 'End'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",,0.0089816,"Product liking and satisfying effects were significantly highest for the UB cigarette; JS products and comparator ENDS did not significantly differ and were rated higher than nicotine gum on most subjective measures.
","[{'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Juul Labs, Inc., United States. Electronic address: nicholas.goldenson@juul.com.'}, {'ForeName': 'August R', 'Initials': 'AR', 'LastName': 'Buchhalter', 'Affiliation': 'PinneyAssociates, Inc., United States.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'Augustson', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Rubinstein', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Van Hoof', 'Affiliation': 'Juul Labs, Inc., United States.'}, {'ForeName': 'Jack E', 'Initials': 'JE', 'LastName': 'Henningfield', 'Affiliation': 'PinneyAssociates, Inc., United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108441']
2921,33250384,Non-invasive brain stimulation as a tool to decrease chronic pain in current opiate users: A parametric evaluation of two promising cortical targets.,"BACKGROUND
Poorly controlled chronic pain can lead to non-prescription use of opiates, which is a growing crisis in our communities. Transcranial magnetic stimulation (TMS) is a non-invasive therapeutic tool which has emerged as a potential treatment option for these patients. It is still unclear, however, if the dorsolateral prefrontal cortex (DLPFC) or the motor cortex (MC) is a more effective treatment location. The purpose of this study was to directly compare the effects of DLPFC versus MC TMS on pain severity and the urge to use opiates among chronic pain patients.
METHODS
Twenty-two individuals with chronic pain currently using prescription opiates were randomized to receive 10, 3000 pulse sessions of 10 Hz repetitive TMS (rTMS) to the left DLPFC (110% resting motor threshold) or left MC (90% resting motor threshold). Multivariate linear models were used to evaluate the effect of TMS on pain and opiate use, including items from the Brief Pain Inventory (BPI) as well as subjective ratings of pain, distress, and the urge for opiates.
RESULTS
Twenty participants (91%) completed all 10 treatment sessions and follow up visits. There was a main effect of stimulation site (F7,210 = 3.742, p = 0.001), wherein MC stimulation decreased pain interference significantly more than DLPFC stimulation (F 1,216 = 8.447, p = 0.004). While both sites had comparable effect sizes on stress, pain, and discomfort, MC stimulation had larger effects on pain interference (Cohen's d: 0.7) and urge to use opiates (Cohen's d: 0.5) than DLPFC stimulation.
CONCLUSION
These data suggest that the MC may be a promising target for decreasing opiate dependence and pain interference among chronic pain patients.",2020,"While both sites had comparable effect sizes on stress, pain, and discomfort, MC stimulation had larger effects on pain interference (Cohen's d: 0.7) and urge to use opiates (Cohen's d: 0.5) than DLPFC stimulation.
","['chronic pain patients', 'Twenty-two individuals with chronic pain currently using prescription opiates', 'current opiate users']","['Transcranial magnetic stimulation (TMS', '3000 pulse sessions of 10 Hz repetitive TMS (rTMS) to the left DLPFC (110% resting motor threshold) or left MC', 'TMS', 'DLPFC versus MC TMS']","['pain severity', 'stress, pain, and discomfort, MC stimulation', 'pain interference', 'pain and opiate use, including items from the Brief Pain Inventory (BPI', 'subjective ratings of pain, distress, and the urge for opiates', 'opiate dependence and pain interference', 'chronic pain']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]",22.0,0.0457266,"While both sites had comparable effect sizes on stress, pain, and discomfort, MC stimulation had larger effects on pain interference (Cohen's d: 0.7) and urge to use opiates (Cohen's d: 0.5) than DLPFC stimulation.
","[{'ForeName': 'Julia P', 'Initials': 'JP', 'LastName': 'Imperatore', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'McCalley', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Borckardt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Administration Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Administration Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Hanlon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Department of Cancer Biology, Wake Forest University School of Medicine, Winston-Salem, NC, USA. Electronic address: chanlon@wakehealth.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108409']
2922,33250284,"Biomechanical Study Comparing Pulvertaft, Double Side-to-Side, and Locking Side-to-Side Tendon Suture Techniques.","PURPOSE
In this study, we present a single-sided locking side-to-side (STS) suture technique as a possible alternative for the Pulvertaft weave in tendon transfers. The aim of the study was to compare the biomechanical characteristics of the single-sided locking STS reconstruction with Pulvertaft and double-sided nonlocking STS reconstructions.
METHODS
Twenty-four human cadaveric extensor digitorum communis tendons and 24 flexor digitorum superficialis tendons were randomly assigned to 1 of 3 groups, resulting in a total of 8 flexor tendons and 8 extensor tendons per group: Pulvertaft, double-sided nonlocking STS, and single-sided locking STS reconstructions. Load to failure was measured with a tensile testing machine. Increase in cross-sectional area was used as a measure of bulkiness at the reconstruction site.
RESULTS
In extensor tendons, single-sided locking STS reconstructions showed a higher load to failure than Pulvertaft reconstructions, whereas no difference was found in load to failure between single-sided locking and double-sided nonlocking STS reconstructions. In flexor tendons, single-sided locking STS reconstructions showed a higher load to failure than Pulvertaft reconstructions. However, load to failure of single-sided locking STS reconstructions was less than double-sided nonlocking STS reconstructions. In both extensor and flexor tendons, the percent increase in cross-sectional area at the reconstruction site was higher in Pulvertaft reconstructions than single-sided locking STS reconstructions, whereas no difference was found between single-sided locking STS and double-sided nonlocking STS reconstructions.
CONCLUSIONS
Single-sided locking and double-sided nonlocking STS reconstructions are suitable alternatives to the Pulvertaft technique for tendon transfers owing to a higher strength and less bulkiness. Because load to failure of both STS reconstructions did not differ in extensor tendon transfers, the single-sided locking STS reconstruction seems especially suitable for extensor tendon transfers.
CLINICAL RELEVANCE
This study provides anatomical evidence that the single-sided locking STS reconstruction yields a higher strength and is less bulky than the Pulvertaft reconstruction in tendon transfers.",2020,"In flexor tendons, single-sided locking STS reconstructions showed a higher load to failure than Pulvertaft reconstructions.",['Twenty-four human cadaveric extensor digitorum communis tendons and 24 flexor digitorum superficialis tendons'],"['single-sided locking side-to-side (STS) suture technique', 'Pulvertaft, Double Side-to-Side, and Locking Side-to-Side Tendon Suture Techniques', 'single-sided locking STS reconstruction with Pulvertaft and double-sided nonlocking STS reconstructions', 'flexor tendons and 8 extensor tendons per group: Pulvertaft, double-sided nonlocking STS, and single-sided locking STS reconstructions']",['cross-sectional area'],"[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0224268', 'cui_str': 'Structure of extensor digitorum muscle of hand'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0224915', 'cui_str': 'Structure of superficial flexor tendon of finger'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0224848', 'cui_str': 'Structure of flexor tendon'}, {'cui': 'C0224849', 'cui_str': 'Structure of extensor tendon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",24.0,0.0452026,"In flexor tendons, single-sided locking STS reconstructions showed a higher load to failure than Pulvertaft reconstructions.","[{'ForeName': 'Jaimy E', 'Initials': 'JE', 'LastName': 'Koopman', 'Affiliation': 'Department of Plastic, Reconstructive Surgery and Hand Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Hundepool', 'Affiliation': 'Department of Plastic, Reconstructive Surgery and Hand Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Liron S', 'Initials': 'LS', 'LastName': 'Duraku', 'Affiliation': 'Department of Plastic, Reconstructive Surgery and Hand Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Mick', 'Initials': 'M', 'LastName': 'Kreulen', 'Affiliation': 'Department of Hand Surgery, Rode Kruis Ziekenhuis, Beverwijk, The Netherlands.'}, {'ForeName': 'J Michiel', 'Initials': 'JM', 'LastName': 'Zuidam', 'Affiliation': 'Department of Plastic, Reconstructive Surgery and Hand Surgery, Erasmus Medical Centre, Rotterdam, The Netherlands. Electronic address: j.zuidam@erasmusmc.nl.'}]",The Journal of hand surgery,['10.1016/j.jhsa.2020.09.015']
2923,33250271,Using the Patient Concerns Inventory in the identification of fatigue following treatment for head and neck cancer.,"Fatigue has a profound impact on health-related quality of life (HRQOL). The aim of this study was to describe the clinical characteristics and HRQOL of head and neck cancer patients who raised the issue of fatigue on the Patient Concerns Inventory (PCI) at their review consultation. Eight consultants were randomized to use the PCI as part of a cluster-controlled trial. Patients also completed the University of Washington Quality of Life version 4 (UWQOL), EQ-5D-5L (EuroQol Group), and Distress Thermometer questionnaires. The study included 140 patients who attended clinics at a median of 108 (interquartile range 70-165) days after the end of treatment. The PCI item 'fatigue' was the sixth most commonly selected, by 29% (n=40). Those with advanced tumours were more likely to have selected the item (30/84, 36% vs 10/56, 18%; P=0.02), as were those treated with radiotherapy±chemotherapy (34/87, 39% vs 6/53, 11%; P<0.001). The PCI fatigue group reported significantly worse overall quality of life, social-emotional and physical function composite scores (UWQOL), Distress Thermometer, and EQ-5D-5L. PCI fatigue was common in those with sleeping, nausea, mood, depression, mobility, breathing, and energy level concerns. In conclusion, given the problems associated with fatigue, it is appropriate to screen and seek interventions that might help patients address this.",2020,"The PCI fatigue group reported significantly worse overall quality of life, social-emotional and physical function composite scores (UWQOL), Distress Thermometer, and EQ-5D-5L. PCI fatigue was common in those with sleeping, nausea, mood, depression, mobility, breathing, and energy level concerns.","['head and neck cancer patients who raised the issue of fatigue on the Patient Concerns Inventory (PCI) at their review consultation', 'head and neck cancer', '140 patients who attended clinics at a median of 108 (interquartile range 70-165) days after the end of treatment']",['radiotherapy±chemotherapy'],"['University of Washington Quality of Life version 4 (UWQOL), EQ-5D-5L (EuroQol Group), and Distress Thermometer questionnaires', 'nausea, mood, depression, mobility, breathing, and energy level concerns', 'health-related quality of life (HRQOL', ""PCI item 'fatigue"", 'overall quality of life, social-emotional and physical function composite scores (UWQOL), Distress Thermometer, and EQ-5D-5L. PCI fatigue']","[{'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0730261', 'cui_str': 'Attending clinic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0039818', 'cui_str': 'Thermometer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",140.0,0.0921803,"The PCI fatigue group reported significantly worse overall quality of life, social-emotional and physical function composite scores (UWQOL), Distress Thermometer, and EQ-5D-5L. PCI fatigue was common in those with sleeping, nausea, mood, depression, mobility, breathing, and energy level concerns.","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Faculty of Health and Social Care, Edge Hill University, Ormskirk, UK; Liverpool Head and Neck Centre, Liverpool University Hospital Aintree, Liverpool, UK. Electronic address: simonn.rogers@liverpoolft.nhs.uk.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Semple', 'Affiliation': 'Institute of Nursing and Health Research, Ulster University, Newtownabbey, Co. Antrim, UK; South Eastern Health and Social Care, Upper Newtownards Road, Belfast, UK. Electronic address: cherith.semple@setrust.hscni.net.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Humphris', 'Affiliation': 'School of Medicine, Medical and Biological Sciences, University of St Andrews, St Andrews, UK. Electronic address: gmh4@st-andrews.ac.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Astraglobe Ltd, Congleton, Cheshire, UK. Electronic address: astraglobeltd@btconnect.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanatas', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology, Leeds Dental Institute and Leeds General Infirmary, Leeds, UK. Electronic address: anastasios.kanatas@nhs.net.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.11.001']
2924,33250209,Eptinezumab for the Prevention of Episodic Migraine: Sustained Effect Through 1 Year of Treatment in the PROMISE-1 Study.,"PURPOSE
The Prevention of Migraine via Intravenous ALD403 Safety and Efficacy 1 (PROMISE-1) study was a phase III, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, tolerability, and pharmacokinetic properties of repeat intravenous (IV) doses of the calcitonin gene-related peptide‒targeted monoclonal antibody eptinezumab (ALD403) for migraine prevention in adults with episodic migraine. Here we present the results of PROMISE-1 through 1 year of treatment (up to 4 doses).
METHODS
Patients received up to 4 IV administrations of eptinezumab 30 mg, 100 mg, 300 mg, or placebo every 12 weeks. Patients recorded migraine and headache in an electronic diary daily. Additional assessments, including the patient-reported outcomes, were performed at regularly scheduled clinic visits throughout the 56-week study period.
FINDINGS
A total of 888 adults (mean age, 39.8 years; 84.3% female; 83.8% white) received treatment: eptinezumab 30 mg, n = 219; eptinezumab 100 mg, n = 223; eptinezumab 300 mg, n = 224; and placebo, n = 222. During the primary 12-week study evaluation period, single doses of eptinezumab 100 mg and 300 mg led to significant reductions in mean monthly migraine-days versus placebo, beginning as early as the first day after the initial dose. The reduction in mean monthly migraine-days was maintained throughout the study (100 mg, -3.9, -4.5, -4.7, and -4.5 days; 300 mg, -4.3, -4.8, -5.1, and -5.3 days; and placebo, -3.2, -3.8, -4.0, and -4.0 days during weeks 1-12, 13-24, 25-36, and 37-48, respectively). Overall, the number of patients with a ≥50% or ≥75% reduction in migraine for each 12-week interval during the entire study was consistently numerically higher in the eptinezumab groups than in the placebo group. The proportions of patients with ≥50% reduction in migraine were similar across the eptinezumab groups. Eptinezumab was well tolerated throughout the study. Adverse events were similar across dosing periods, and there were no serious tolerability signals identified with continued dosing.
IMPLICATIONS
IV eptinezumab administered every 12 weeks for up to 4 doses was associated with early and sustained migraine-preventive effects and a favorable safety profile in adults with episodic migraine. ClinicalTrials.gov identifier: NCT02559895.",2020,"The reduction in mean monthly migraine-days was maintained throughout the study (100 mg, -3.9, -4.5, -4.7, and -4.5 days; 300 mg, -4.3, -4.8, -5.1, and -5.3 days; and placebo, -3.2, -3.8, -4.0, and -4.0 days during weeks 1-12, 13-24, 25-36, and 37-48, respectively).","['adults with episodic migraine', 'A total of 888 adults (mean age, 39.8 years; 84.3% female; 83.8% white) received']","['calcitonin gene-related peptide‒targeted monoclonal antibody eptinezumab (ALD403', 'Eptinezumab', 'eptinezumab', 'placebo', 'eptinezumab 100\xa0mg, n\xa0=\xa0223; eptinezumab 300\xa0mg, n\xa0=\xa0224; and placebo', 'treatment: eptinezumab', 'eptinezumab 30\xa0mg, 100\xa0mg, 300\xa0mg, or placebo']","['efficacy, tolerability, and pharmacokinetic properties', 'mean monthly migraine-days', 'migraine and headache', 'Adverse events', 'migraine']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0006668', 'cui_str': 'Calcitonin'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C4694272', 'cui_str': 'eptinezumab'}, {'cui': 'C4743169', 'cui_str': 'ALD403'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",888.0,0.0799046,"The reduction in mean monthly migraine-days was maintained throughout the study (100 mg, -3.9, -4.5, -4.7, and -4.5 days; 300 mg, -4.3, -4.8, -5.1, and -5.3 days; and placebo, -3.2, -3.8, -4.0, and -4.0 days during weeks 1-12, 13-24, 25-36, and 37-48, respectively).","[{'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Smith', 'Affiliation': 'StudyMetrix Research, St. Peters, MO, USA. Electronic address: tsmith@studymetrix.com.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Janelidze', 'Affiliation': 'Department of Neurology, Tbilisi State Medical University, Tbilisi, Georgia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Chakhava', 'Affiliation': 'Multiprofile Clinic Consilium Medulla, Georgian Association of Medical Specialties, Tbilisi, Georgia.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Cady', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals Inc, Bothell, WA, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Hirman', 'Affiliation': 'Pacific Northwest Statistical Consulting Inc, Woodinville, WA, USA.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Allan', 'Affiliation': 'Alder BioPharmaceuticals Inc (now Known as Lundbeck Seattle BioPharmaceuticals Inc), Bothell, WA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pederson', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals Inc, Bothell, WA, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Alder BioPharmaceuticals Inc (now Known as Lundbeck Seattle BioPharmaceuticals Inc), Bothell, WA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schaeffler', 'Affiliation': 'Lundbeck Seattle BioPharmaceuticals Inc, Bothell, WA, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.11.007']
2925,33250205,Olaparib maintenance therapy in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 mutation: SOLO1 China cohort.,"PURPOSE
Maintenance therapy with the poly(ADP-ribose) polymerase (PARP) inhibitor olaparib provided a substantial progression-free survival (PFS) benefit compared with placebo in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (BRCAm) who were in clinical complete or partial response following platinum-based chemotherapy in the Phase III SOLO1 global study. This led to the approval of maintenance olaparib in China, USA, EU, Japan and other countries, in the newly diagnosed setting. This separate China cohort of the SOLO1 study investigated the efficacy and safety of maintenance olaparib within the Chinese population.
PATIENTS AND METHODS
In this double-blind, multicentre study, patients were randomized 2:1 to receive oral olaparib tablets (300 mg twice daily) or placebo. The primary endpoint was investigator-assessed PFS (modified RECIST v1.1).
RESULTS
Of the 64 randomized patients, 44 received olaparib and 20 placebo. Olaparib reduced the risk of disease progression or death by 54% compared with placebo (HR 0.46, 95% Cl 0.23-0.97; median PFS was not reached in the olaparib arm vs 9.3 months in the placebo arm). The most common AEs in the olaparib arm were nausea (63.6 vs 25.0% with placebo), anaemia (59.1 vs 15.0%) and leukopenia (54.5 vs 20.0%). Grade ≥3 AEs were experienced by 56.8% of olaparib patients and 30.0% of placebo patients.
CONCLUSIONS
Results in the SOLO1 China cohort support the use of olaparib as maintenance treatment for Chinese patients with newly diagnosed advanced ovarian cancer who have a BRCAm and are in complete or partial response after platinum-based chemotherapy.",2020,"Olaparib reduced the risk of disease progression or death by 54% compared with placebo (HR 0.46, 95%","['patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 mutation: SOLO1 China cohort', '64 randomized patients', 'Chinese patients with newly diagnosed advanced ovarian cancer', 'patients with newly diagnosed advanced ovarian cancer and a BRCA mutation (BRCAm) who were in clinical complete or partial response following']","['placebo', 'olaparib and 20 placebo', 'platinum-based chemotherapy', 'olaparib', 'Olaparib maintenance therapy', 'poly(ADP-ribose) polymerase', 'oral olaparib tablets']","['risk of disease progression or death', 'anaemia', 'nausea', 'median PFS', 'Grade ≥3 AEs', 'investigator-assessed PFS (modified RECIST v1.1', 'leukopenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C1528558', 'cui_str': 'BRCA1 protein, human'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032405', 'cui_str': 'Poly ADP Ribose Polymerase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4520027', 'cui_str': 'olaparib Oral Tablet'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",64.0,0.753118,"Olaparib reduced the risk of disease progression or death by 54% compared with placebo (HR 0.46, 95%","[{'ForeName': 'Lingying', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: wulingying@csco.org.cn.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Rutie', 'Initials': 'R', 'LastName': 'Yin', 'Affiliation': 'Department of Gynecology and Obstetrics, West China Second University Hospital, Sichuan University, Chengdu, China; Key Laboratory of Obstetrics and Gynecologic and Pediatric Diseases and Birth Defects of the Ministry of Education, West China Second University Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Ge', 'Initials': 'G', 'LastName': 'Lou', 'Affiliation': 'Department of Gynecology and Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Gynecologic Oncology, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Yunong', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Beihua', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Gynecologic Oncology, Fudan University, Shanghai, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Chongqing Cancer Hospital, Chongqing, China.'}, {'ForeName': 'Yueling', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""No.1 Affiliated Hospital of Medical School, Xi'an Jiaotong University, China.""}, {'ForeName': 'Youguo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Women's Hospital Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Oncology Center, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'AstraZeneca, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'AstraZeneca, Shanghai, China.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.10.005']
2926,33250012,Does forward head posture change subacromial space in active or passive arm elevation?,"Objectives : Forward head posture (FHP) is one of the most common musculoskeletal disorders that appears to affect the shoulder joint through the shared muscles between the head and neck area and the shoulder girdle. The present study compared the acromiohumeral distance between individuals with normal head and neck alignment and those with moderate and severe FHP in active and passive arm elevation. Methods : Based on the craniovertebral angle, 60 volunteers were selected and equally distributed among three groups, including group one with normal head and neck alignment, group two with moderate FHP and group three with severe FHP. The space between the humeral head and the acromion was measured in 10°, 45° and 60° of active and passive arm elevation as the acromiohumeral distance. Results : The acromiohumeral distance was only different between the three groups at 45° arm elevation angle, and this difference was significant between groups one and three. In active and passive arm elevation, increased arm elevation angle reduced the subacromial space significantly. Also, in each arm elevation angle, the subacromial space differed significantly between the active and passive arm elevations. Conclusions : The acromiohumeral distance was significantly lower in the severe FHP group than the group with normal head and neck alignment in the 45° active arm elevation angle, which could be due to the changed tension in tissues between active and passive arm elevation and also the maximum muscle activity in the 45° active arm elevation angle.",2020,"The acromiohumeral distance was significantly lower in the severe FHP group than the group with normal head and neck alignment in the 45° active arm elevation angle, which could be due to the changed tension in tissues between active and passive arm elevation and also the maximum muscle activity in the 45° active arm elevation angle.","['individuals with normal head and neck alignment and those with moderate and severe FHP in active and passive arm elevation', '60 volunteers were selected and equally distributed among three groups, including group one with normal head and neck alignment, group two with moderate FHP and group three with severe FHP']",['head posture (FHP'],"['acromiohumeral distance', 'subacromial space']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C1536116', 'cui_str': 'Head posture abnormal'}, {'cui': 'C0439780', 'cui_str': 'Forward'}]","[{'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",60.0,0.0449527,"The acromiohumeral distance was significantly lower in the severe FHP group than the group with normal head and neck alignment in the 45° active arm elevation angle, which could be due to the changed tension in tissues between active and passive arm elevation and also the maximum muscle activity in the 45° active arm elevation angle.","[{'ForeName': 'Behdokht', 'Initials': 'B', 'LastName': 'Dehqan', 'Affiliation': 'Department of Physiotherapy, Rehabilitation Faculty, Semnan University of Medical Sciences , Semnan, Iran.'}, {'ForeName': 'Cyrus Taghizadeh', 'Initials': 'CT', 'LastName': 'Delkhoush', 'Affiliation': 'Department of Physiotherapy, Rehabilitation Faculty, Semnan University of Medical Sciences , Semnan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mirmohammadkhani', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Medicine, Semnan University of Medical Sciences , Semnan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Department of Physiotherapy, Rehabilitation Faculty, Semnan University of Medical Sciences , Semnan, Iran.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2020.1854010']
2927,33249985,Topical cream containing nanoparticles with vitamin E to prevent radiodermatitis in women with breast cancer: a clinical trial protocol.,"OBJECTIVE
Little is known about the efficacy of products aiming to prevent radiodermatitis, which affects between 90-95% of women with breast cancer. The use of antioxidants is promising, however, there is a lack of evidenceon their effectiveness. Here, the authors present a clinical trial protocol to evaluate the effects of applying a cream containing nanoparticles with vitamin E to prevent radiodermatitis in patients with breast cancer.
METHOD
The protocol recommends that 108 women with breast cancer, receiving radiotherapy, are included in this triple-blinded, randomized, controlled study at an oncology hospital. Patients will be divided in three groups of 36 individuals each: group A will receive a cream with lipid nanoparticles and vitamin E, group B will receive a cream without nanoparticles nor vitamin E, and group C will receive a cream with nanoparticles without vitamin E. The primary endpoints will evaluate the incidence, degree, and time of onset of radiodermatitis. The secondary endpoints will focus on the quality of life, symptoms, and local temperature. Patients will be assessed three times a week, from the start of their radiotherapy treatment to two weeks after the last session. This protocol was approved by the research ethics committee of the institutions involved and registered on an international trials database.",2020,"OBJECTIVE
Little is known about the efficacy of products aiming to prevent radiodermatitis, which affects between 90-95% of women with breast cancer.","['patients with breast cancer', 'women with breast cancer', '108 women with breast cancer, receiving']","['radiotherapy', 'cream with lipid nanoparticles and vitamin E, group B will receive a cream without nanoparticles nor vitamin E, and group C will receive a cream with nanoparticles without vitamin E', 'cream containing nanoparticles with vitamin E', 'Topical cream containing nanoparticles with vitamin E']","['quality of life, symptoms, and local temperature', 'incidence, degree, and time of onset of radiodermatitis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0991551', 'cui_str': 'Cutaneous cream'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0034561', 'cui_str': 'Radiation dermatitis'}]",108.0,0.185092,"OBJECTIVE
Little is known about the efficacy of products aiming to prevent radiodermatitis, which affects between 90-95% of women with breast cancer.","[{'ForeName': 'Fernanda Mateus Queiróz', 'Initials': 'FMQ', 'LastName': 'Schmidt', 'Affiliation': 'Instituto Federal de Educação, Ciência e Tecnologia do Sul de Minas Gerais (IFSULDEMINAS), Passos, Minas Gerais, Brazil.'}, {'ForeName': 'Carol V Serna', 'Initials': 'CVS', 'LastName': 'González', 'Affiliation': 'Graduate Program in Adult Health Nursing, Universidade de São Paulo, Escola de Enfermagem (EEUSP), Sao Paulo, Brazil.'}, {'ForeName': 'Rodrigo Calixto', 'Initials': 'RC', 'LastName': 'Mattar', 'Affiliation': 'Cancer Regional Hospital, Santa Casa de Misericórdia de Passos, Minas Gerais, Brazil.'}, {'ForeName': 'Luciana Biagini', 'Initials': 'LB', 'LastName': 'Lopes', 'Affiliation': 'Pharmacology Department, Universidade de São Paulo, Instituto de Ciências Biomédicas (ICB-USP), Sao Pablo, Brazil.'}, {'ForeName': 'Marinilce Fagundes Dos', 'Initials': 'MFD', 'LastName': 'Santos', 'Affiliation': 'Cell Biology and Development Department, Universidade de São Paulo, Instituto de Ciências Biomédicas (ICB-USP), Sao Pablo, Brazil.'}, {'ForeName': 'Vera L C', 'Initials': 'VLC', 'LastName': 'de Gouveia Santos', 'Affiliation': 'Department of Medial-Surgical Nursing, Universidade de São Paulo, Escola de Enfermagem (EEUSP), Sao Paulo, Brazil.'}]",Journal of wound care,['10.12968/jowc.2020.29.LatAm_sup_1.18.eng']
2928,33249909,The effect of femoral stem collar on implant migration and clinical outcomes following direct anterior approach total hip arthroplasty.,"AIMS
The direct anterior (DA) approach has been associated with rapid patient recovery after total hip arthroplasty (THA) but may be associated with more frequent femoral complications including implant loosening. The objective of this study was to determine whether the addition of a collar to the femoral stem affects implant migration, patient activity, and patient function following primary THA using the DA approach.
METHODS
Patients were randomized to either a collared (n = 23) or collarless (n = 26) cementless femoral stem implanted using the DA approach. Canal fill ratio (CFR) was measured on the first postoperative radiographs. Patients underwent a supine radiostereometric analysis (RSA) exam postoperatively on the day of surgery and at two, four, six, 12, 26, and 52 weeks postoperatively. Patient-reported outcome measures (Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the 12-item Short Form Health Survey Mental and Physical Score, and University of California, Los Angeles (UCLA) Activity Score) were measured preoperatively and at each post-surgery clinic visit. Activity and function were also measured as the weekly average step count recorded by an activity tracker, and an instrumented timed up-and-go (TUG) test in clinic, respectively.
RESULTS
Comparing the RSA between the day of surgery baseline exam to two weeks postoperatively, subsidence was significantly lower (mean difference 2.23 mm (SD 0.71), p = 0.023) with collared stems, though these patients had a greater CFR (p = 0.048). There was no difference (p = 0.426) in subsidence between stems from a two-week baseline through to one year postoperatively. There were no clinically relevant differences in PROMs; and there was no difference in the change in activity (p = 0.078) or the change in functional capacity (p = 0.664) between the collared stem group and the collarless stem group at any timepoint.
CONCLUSION
Presence of a collar on the femoral stem resulted in reduced subsidence during the first two postoperative weeks following primary THA using the DA approach. However, the clinical implications are unclear, and larger studies examining patient activity and outcomes are required. Cite this article: Bone Joint J 2020;102-B(12):1654-1661.",2020,There was no difference (p = 0.426) in subsidence between stems from a two-week baseline through to one year postoperatively.,"['Patients were randomized to either a collared (n = 23) or collarless (n = 26', 'direct anterior approach total hip arthroplasty']","['femoral stem collar', 'cementless femoral stem implanted using the DA approach']","['Activity and function', 'outcome measures (Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, the 12-item Short Form Health Survey Mental and Physical Score, and University of California, Los Angeles (UCLA', 'change in activity', 'Canal fill ratio (CFR', 'PROMs', 'functional capacity', 'Activity Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015944', 'cui_str': 'Premature rupture of membranes'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",,0.0781843,There was no difference (p = 0.426) in subsidence between stems from a two-week baseline through to one year postoperatively.,"[{'ForeName': 'Maxwell E', 'Initials': 'ME', 'LastName': 'Perelgut', 'Affiliation': 'School of Biomedical Engineering, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Polus', 'Affiliation': 'School of Biomedical Engineering, Western University, London, Ontario, Canada.'}, {'ForeName': 'Brent A', 'Initials': 'BA', 'LastName': 'Lanting', 'Affiliation': 'Division of Orthopaedic Surgery, Schulich School of Medicine & Dentistry, Western University, London, Ontario, Canada.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Teeter', 'Affiliation': 'School of Biomedical Engineering, Western University, London, Ontario, Canada.'}]",The bone & joint journal,['10.1302/0301-620X.102B12.BJJ-2019-1428.R1']
2929,33249906,Results of a randomized controlled trial with five-year radiostereometric analysis results of vitamin E-infused highly crosslinked versus moderately crosslinked polyethylene in reverse total hip arthroplasty.,"AIMS
Vitamin E-infused highly crosslinked polyethylene (VEPE) has been introduced into total hip arthroplasty (THA) with the aim of further improving the wear characteristics of moderately and highly crosslinked polyethylenes (ModXLPE and HXLPE). There are few studies analyzing the outcomes of vitamin E-infused components in cemented arthroplasty, though early acetabular component migration has been reported. The aim of this study was to measure five-year polyethylene wear and acetabular component stability of a cemented VEPE acetabular component compared with a ModXLPE cemented acetabular component.
METHODS
In a prospective randomized controlled trial (RCT), we assessed polyethylene wear and acetabular component stability (primary outcome) with radiostereometric analysis (RSA) in 68 patients with reverse hybrid THA at five years follow-up. Patients were randomized to either a VEPE or a ModXLPE cemented acetabular component.
RESULTS
Mean polyethylene wear in the proximal direction was 0.17 mm (SD 0.15) for the VEPE group and 0.20 mm (SD 0.09) for the ModXLPE group (p = 0.005) at five years. Annual proximal wear rates were 0.03 mm/year (VEPE) and 0.04 mm/year (ModXLPE). Total 3D wear was 0.21 mm (SD 0.26) and 0.23 mm (SD 0.10) for the VEPE and ModXLPE groups, respectively (p = 0.009). Total 3D cup translation was 0.72 mm (SD 0.70) (VEPE) and 0.50 mm (SD 0.44) (ModXLPE) (p = 0.409).
CONCLUSION
At five years, there was less polyethylene wear in the VEPE group than in the ModXLPE group. Both VEPE and ModXLPE cemented components showed low annual wear rates. Component stability was similar in the two groups and remained constant up to five years. Whether these results will equate to a lower long-term revision rate is still unknown. Cite this article: Bone Joint J 2020;102-B(12):1646-1653.",2020,Mean polyethylene wear in the proximal direction was 0.17 mm (SD 0.15) for the VEPE group and 0.20 mm (SD 0.09) for the ModXLPE group (p = 0.005) at five years.,"['total hip arthroplasty (THA', 'reverse total hip arthroplasty', '68 patients with reverse hybrid THA at five years follow-up']","['ModXLPE', 'ModXLPE cemented acetabular component', 'cemented VEPE acetabular component', 'radiostereometric analysis (RSA', 'Vitamin E-infused highly crosslinked polyethylene (VEPE', 'VEPE', 'vitamin E-infused highly crosslinked versus moderately crosslinked polyethylene']","['low annual wear rates', 'Annual proximal wear rates', 'Total 3D cup translation', 'Total 3D wear', 'Component stability', 'Mean polyethylene wear in the proximal direction']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C3178874', 'cui_str': 'Roentgen Stereophotogrammetry'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",68.0,0.225392,Mean polyethylene wear in the proximal direction was 0.17 mm (SD 0.15) for the VEPE group and 0.20 mm (SD 0.09) for the ModXLPE group (p = 0.005) at five years.,"[{'ForeName': 'Peder S', 'Initials': 'PS', 'LastName': 'Thoen', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nordsletten', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Are H', 'Initials': 'AH', 'LastName': 'Pripp', 'Affiliation': 'Department of Biostatistics, Oslo University Hospital Ullevål, Oslo, Norway.'}, {'ForeName': 'Stephan M', 'Initials': 'SM', 'LastName': 'Röhrl', 'Affiliation': 'Division of Orthopedic Surgery, Oslo University Hospital Ullevål, Oslo, Norway.'}]",The bone & joint journal,['10.1302/0301-620X.102B12.BJJ-2020-0721.R1']
2930,33249632,Group-randomized trial of tailored brief shared decision-making to improve asthma control in urban black adults.,"AIMS
To assess the intervention effects of BREATHE (BRief intervention to Evaluate Asthma THErapy), a novel brief shared decision-making intervention and evaluate feasibility and acceptability of intervention procedures.
DESIGN
Group-randomized longitudinal pilot study.
METHODS
In total, 80 adults with uncontrolled persistent asthma participated in a trial comparing BREATHE (N = 40) to a dose-matched attention control intervention (N = 40). BREATHE is a one-time shared decision-making intervention delivered by clinicians during routine office visits. Ten clinicians were randomized and trained on BREATHE or the control condition. Participants were followed monthly for 3 months post-intervention. Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews.
RESULTS
Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45). BREATHE clinicians delivered BREATHE to all 40 participants with fidelity based on expert review of audiorecordings. While the control group reported improvements in asthma control at 1-month and 3-month follow-up, only BREATHE participants had better asthma control at each timepoint (β = 0.77; standard error (SE)[0.17]; p ≤ 0.0001; β = 0.71; SE[0.16]; p ≤ 0.0001; β = 0.54; SE[0.15]; p = .0004), exceeding the minimally important difference. BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls. Both groups reported improved adherence and fewer erroneous medication beliefs.
CONCLUSION
BREATHE is a promising brief tailored intervention that can be integrated into office visits using clinicians as interventionists. Thus, BREATHE offers a pragmatic approach to improving asthma outcomes and shared decision-making in a health disparity population.
IMPACT
The study addressed the important problem of uncontrolled asthma in a high-risk vulnerable population. Compared with the dose-matched attention control condition, participants receiving the novel brief tailored shared decision-making intervention had significant improvements in asthma outcomes and greater perceived engagement in shared decision-making. Brief interventions integrated into office visits and delivered by clinicians may offer a pragmatic approach to narrowing health disparity gaps. Future studies where other team members (e.g., office nurses, social workers) are trained in shared decision-making may address important implementation science challenges as it relates to adoption, maintenance, and dissemination. TRAIL REGISTRATION: clinicaltrials.gov # NCT03300752.",2020,"BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls.","['Participants were Black/multiracial (100%) mostly female (83%) adults (mean age 45', 'Data were collected from December 2017 - May 2019 and included surveys, lung function tests, and interviews', 'uncontrolled asthma in a high-risk vulnerable population', 'urban black adults', '80 adults with uncontrolled persistent asthma', '40 participants with fidelity based on expert review of audiorecordings']","['tailored brief shared decision-making', 'dose-matched attention control intervention']","['shortness of breath and less severity of symptoms', 'asthma outcomes and greater perceived engagement in shared decision-making', 'asthma control', 'adherence and fewer erroneous medication beliefs']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0699752', 'cui_str': 'Review of'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C3179495', 'cui_str': 'Decision Making, Shared'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C3541364', 'cui_str': 'Erroneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",80.0,0.0381982,"BREATHE participants also perceived greater shared decision-making occurred during the intervention visit (β = 7.39; SE[3.51]; p = .03) and fewer symptoms at follow-up (e.g., fewer nights woken, less shortness of breath and less severity of symptoms) than the controls.","[{'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Bruzzese', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Lynn S Sommers', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Department of Emergency Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Haomiao', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Columbia University School of Nursing, Columbia University Mailman School of Public Health, New York, NY, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Rhodes', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Allison A', 'Initials': 'AA', 'LastName': 'Norful', 'Affiliation': 'Columbia University School of Nursing, New York, NY, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Chung', 'Affiliation': 'Center for Health Behavior Research, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Chittams', 'Affiliation': 'Biostatistics Analysis Core, University of Pennsylvania School of Nursing, Philadelphia, PA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Coleman', 'Affiliation': 'Xxxx, Philadelphia, PA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Glanz', 'Affiliation': 'Perelman School of Medicine and School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of advanced nursing,['10.1111/jan.14646']
2931,33249630,"Randomised clinical trial: safety, efficacy and pharmacokinetics of HS-10234 versus tenofovir for the treatment of chronic hepatitis B infection.","BACKGROUND
HS-10234 is a novel prodrug of tenofovir developed to increase anti-viral potency and to reduce systemic toxicities.
AIMS
To evaluate the tolerability, pharmacokinetics and anti-viral efficacy of HS-10234 in patients with chronic hepatitis B (CHB) infection METHODS: Treatment-naïve subjects with non-cirrhotic CHB were divided into three groups (n = 12/group) and randomised within each group to receive 10, 25 or 40 mg of HS-10234, or 300 mg of tenofovir disoproxil fumarate (TDF) once a day for 28 days.
RESULTS
Among 36 enrolled subjects, 33.3% were hepatitis B e antigen-negative with a mean hepatitis B virus (HBV) DNA level of 6.32-7.42 log 10 IU/mL. Nephrotoxicity and serious adverse events were not observed; all adverse events were mild or moderate and non-specific. The mean reductions in serum HBV DNA after 28 days were -2.70, -2.89, -2.72 and -3.04 log 10 IU/mL for treatment with 10, 25 or 40 mg HS-10234, and 300 mg TDF, respectively. HS-10234 and its metabolite TFV showed linear, dose-proportional pharmacokinetics. The concentrations of active TFV-DP in peripheral blood mononuclear cells were higher (approximately 2- to 11-fold increase) and TFV in plasma were lower (approximately 4.5- to 25-fold reduction) in subjects taking HS-10234 than those in the TDF group.
CONCLUSIONS
HS-10234 was well tolerated during a 4-week course. TDF and HS-10234 had comparable potency in inhibiting HBV replication. A daily dose of 10-25 mg of HS-10234 is recommended for CHB treatment. (Chinese Drug Trial Identifier: CTR20161077).",2020,"The mean reductions in serum HBV DNA after 28 days were -2.70, -2.89, -2.72 and -3.04 log 10 ","['Treatment-naïve subjects with non-cirrhotic CHB', 'chronic hepatitis B infection', 'patients with chronic hepatitis B']","['tenofovir', 'HS-10234 versus tenofovir', 'HS-10234', 'HS-10234, or 300\xa0mg of tenofovir disoproxil fumarate (TDF']","['Nephrotoxicity and serious adverse events', 'concentrations of active TFV-DP in peripheral blood mononuclear cells', 'hepatitis B e antigen-negative with a mean hepatitis B virus (HBV) DNA level', 'serum HBV DNA', 'TFV in plasma', 'tolerability, pharmacokinetics and anti-viral efficacy']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}]","[{'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019378', 'cui_str': 'Cercopithecine herpesvirus 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",36.0,0.136687,"The mean reductions in serum HBV DNA after 28 days were -2.70, -2.89, -2.72 and -3.04 log 10 ","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Jingrui', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaoxue', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Xiaojiao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Cuiyun', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Chengjiao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Junqi', 'Initials': 'J', 'LastName': 'Niu', 'Affiliation': 'Department of Hepatology, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Phase I Clinical Research Center, The First Hospital of Jilin University, Jilin, China.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.16196']
2932,33249611,Are Paula method exercises effective for gastrointestinal reactivation post-elective cesarean delivery? Randomized controlled trial.,"AIM
To examine the effectiveness of the Paula Method exercises in comparison to standard care on resumption of gastrointestinal (GI) activity in women postelective caesarean delivery (CD).
DESIGN
Randomized controlled trial on a postpartum unit of a university medical centre.
METHODS
Sixty-four women following elective CD performed under regional anaesthesia were recruited between 2 February-3 July 2018. Participants were randomized into two groups: The Paula Method exercise group (intervention group) and the control group. Women in the intervention group performed circular muscle exercises according to the Paula Method and received standard care, while those in the control group were treated only with standard care. Time to first bowel sounds, passage of first flatus and first defecation after CD were measured.
RESULTS
A significant difference was found in the time to passage of first flatus, in favour of the intervention group (24.07 [6.85] hours versus 39.07 [10.37] hours; p < .001). No significant differences between the groups were found for other main outcome measures.
CONCLUSION
Paula Method exercises post CD can serve as natural and convenient alternative to the standard, conservative treatment to promote resumption of GI activity.
IMPACT
CD can be associated with postoperative ineffective peristalsis that can lead to a paralytic ileus. Since standard methods are not sufficient for all women, there is a need for alternative modalities to accelerate the resumption of bowel functioning. In the Paula Method exercise group, time to first flatus passage occurred significantly sooner compared with the control group. Time to first defecation was earlier in the Paula Method exercise group but this difference did not reach statistical significance. Along with gum chewing, Paula Method exercises can be part of a simple and inexpensive GI activation strategy post CD. Further research should be performed using these exercises post other operative procedures.",2020,"In the Paula Method exercise group, time to first flatus passage occurred significantly sooner compared with the control group.","['women postelective caesarean delivery (CD', 'Sixty-four women following elective CD performed under regional anaesthesia were recruited between 2 February-3 July 2018', 'postpartum unit of a university medical centre']","['Paula Method exercises', 'circular muscle exercises according to the Paula Method and received standard care', 'Paula Method exercise group (intervention group) and the control group']","['time to first flatus passage', 'Time to first defecation', 'Time to first bowel sounds, passage of first flatus and first defecation after CD', 'resumption of gastrointestinal (GI) activity', 'time to passage of first flatus']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0232693', 'cui_str': 'Bowel sounds'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",64.0,0.0451861,"In the Paula Method exercise group, time to first flatus passage occurred significantly sooner compared with the control group.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Liebergall-Wischnitzer', 'Affiliation': 'Henrietta Szold Nursing Department, Faculty of Medicine, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shaphir', 'Affiliation': 'Department of Obstetrics, Hadassah University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Solnica', 'Affiliation': 'Henrietta Szold Nursing Department, Faculty of Medicine, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Drorith', 'Initials': 'D', 'LastName': 'Hochner-Celnikier', 'Affiliation': 'Department Obstetrics & Gynecology, Hadassah University Hospital, Jerusalem, Israel.'}]",Journal of advanced nursing,['10.1111/jan.14681']
2933,33249593,The effects of recombinant human insulin-like growth factor-1/insulin-like growth factor binding protein-3 administration on lipid and carbohydrate metabolism in recreational athletes.,"OBJECTIVE
Previous studies suggested that recombinant human IGF-1 (rhIGF-1) administration affects carbohydrate and lipid metabolism in healthy people and in people with diabetes. This study aimed to determine the effects of rhIGF-1/rhIGF binding protein-3 (rhIGFBP-3) administration on glucose homeostasis and lipid metabolism in healthy recreational athletes.
DESIGN AND SETTING
Randomized, double-blind, placebo-controlled rhIGF-1/rhIGFBP-3 administration study at Southampton General Hospital, UK.
PARTICIPANTS
56 recreational athletes (30 men, 26 women).
METHODS
Participants were randomly assigned to receive placebo, low-dose rhIGF-1/rhIGFBP-3 (30 mg/day) or high-dose rhIGF-1/rhIGFBP-3 (60 mg/day) for 28 days. The following variables were measured before and immediately after the treatment period: fasting lipids, glucose, insulin, C-peptide and glycated haemoglobin. The homeostatic model assessment (HOMA-IR) was used to estimate insulin sensitivity and indirect calorimetry to assess substrate oxidation rates. The general linear model approach was used to compare treatment group changes with the placebo group.
RESULTS
Compared with the placebo group, there was a significant reduction in fasting triglycerides in participants treated with high-dose rhIGF-1/rhIGFBP-3 (p = .030), but not in the low-dose group (p = .390). In women, but not in men, there were significant increases in total cholesterol (p = .003), HDL cholesterol (p = .001) and LDL cholesterol (p = .008). These lipid changes were associated with reduced fasting insulin (p = .010), C-peptide (p = .001) and HOMA-IR (p = .018) in women and reduced C-peptide (p = .046) in men.
CONCLUSIONS
rhIGF-1/rhIGFBP-3 administration for 28 days reduced insulin concentration, improved insulin sensitivity and had significant effects on lipid profile including decreased fasting triglycerides.",2020,"These lipid changes were associated with reduced fasting insulin (p = .010), C-peptide (p = .001) and HOMA-IR (p = .018) in women and reduced C-peptide (p = .046) in men.
","['56 recreational athletes (30 men, 26 women', 'healthy people and in people with diabetes', 'Participants', 'healthy recreational athletes', 'recreational athletes', 'administration study at Southampton General Hospital, UK']","['rhIGF-1/rhIGF binding protein-3 (rhIGFBP-3', 'placebo', 'placebo, low-dose rhIGF-1/rhIGFBP-3 (30\xa0mg/day) or high-dose rhIGF-1/rhIGFBP-3', 'rhIGF-1/rhIGFBP-3', 'recombinant human IGF-1 (rhIGF-1', 'recombinant human insulin-like growth factor-1/insulin-like growth factor binding protein-3 administration', 'placebo-controlled rhIGF-1/rhIGFBP-3']","['fasting lipids, glucose, insulin, C-peptide and glycated haemoglobin', 'HOMA-IR', 'fasting triglycerides', 'reduced fasting insulin', 'lipid profile including decreased fasting triglycerides', 'glucose homeostasis and lipid metabolism', 'insulin concentration, improved insulin sensitivity', 'substrate oxidation rates', 'LDL cholesterol', 'HDL cholesterol', 'total cholesterol']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0443625', 'cui_str': 'Binding protein 3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0795635', 'cui_str': 'Regular Insulin, Human'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",56.0,0.398484,"These lipid changes were associated with reduced fasting insulin (p = .010), C-peptide (p = .001) and HOMA-IR (p = .018) in women and reduced C-peptide (p = .046) in men.
","[{'ForeName': 'Nishan', 'Initials': 'N', 'LastName': 'Guha', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Nevitt', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Francis', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Walailuck', 'Initials': 'W', 'LastName': 'Böhning', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Dankmar', 'Initials': 'D', 'LastName': 'Böhning', 'Affiliation': 'Southampton Statistical Sciences Research Institute, University of Southampton, Southampton, UK.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Sönksen', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Richard I G', 'Initials': 'RIG', 'LastName': 'Holt', 'Affiliation': 'Human Development and Health, Faculty of Medicine, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}]",Clinical endocrinology,['10.1111/cen.14370']
2934,33257276,Association between patient independence in performing an exercise program and adherence to home exercise program in people with chronic low back pain.,"BACKGROUND
A high percentage of patients with chronic low back pain (LBP) do not adequately adhere to home exercise programs. There is no information regarding a possible association between patient independence in performing an exercise program and adherence to this exercise program.
OBJECTIVE
To assess a possible association between patient independence in performing two different home exercise programs (treatment based on the Movement System Impairment-Based classification model (MSI) and treatment based on stretching and strengthening exercises for chronic LBP and adherence to those exercise programs.
DESIGN
This was a secondary analysis of a randomized controlled trial.
METHODS
The physical therapist assessed the patient's independence in performing the exercise program at the initial physical therapy sessions. Adherence was calculated during the 8-week treatment by the number of days performing the home exercise programs. Multivariate linear regression models were built to investigate whether patient independence in performing the home exercise program was associated with adherence to home exercise program for each treatment group adjusted for possible confounders (age, physical activity status, pain duration, pain intensity and disability at baseline).
RESULTS
We observed a clinically important association between patient independence in performing the home exercise and adherence to a treatment based on the MSI model group (ß = -15.6 days, 95%CI = -24.5 to -6.7, R 2 = 16%, p = 0.001).
CONCLUSIONS
People with chronic LBP adhered more to a home exercise program based on the MSI model when they are more independent in performing the exercise program.",2020,"We observed a clinically important association between patient independence in performing the home exercise and adherence to a treatment based on the MSI model group (ß = -15.6 days, 95%CI = -24.5 to -6.7, R 2 = 16%, p = 0.001).
","['People with chronic LBP', 'patients with chronic low back pain (LBP', 'people with chronic low back pain']","['exercise program and adherence to home exercise program', 'home exercise programs (treatment based on the Movement System Impairment-Based classification model (MSI) and treatment based on stretching and strengthening exercises']",['Adherence'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0485598,"We observed a clinically important association between patient independence in performing the home exercise and adherence to a treatment based on the MSI model group (ß = -15.6 days, 95%CI = -24.5 to -6.7, R 2 = 16%, p = 0.001).
","[{'ForeName': 'Daniel Camara', 'Initials': 'DC', 'LastName': 'Azevedo', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Physical Therapy Department - Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: danielazevedo@pucminas.br.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'de Oliveira Santos', 'Affiliation': 'Physical Therapy Department - Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Daniel Ribeiro', 'Initials': 'DR', 'LastName': 'Oliveira', 'Affiliation': 'Physical Therapy Department - Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Joao Victor', 'Initials': 'JV', 'LastName': 'Leite de Souza', 'Affiliation': 'Physical Therapy Department - Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Leonardo Oliveira', 'Initials': 'LO', 'LastName': 'Pena Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Musculoskeletal Division, The George Institute for Global Health, Sydney, NSW, Australia.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102285']
2935,33257263,Feasibility study of a modified yoga program for chronic pain among elderly adults in assisted and independent living.,"CONTEXT
Yoga improves quality of life in elders ≥65 years, but studies among elders with chronic pain are limited.
OBJECTIVE
Conduct a feasibility study of gentle yoga among elders in assisted and independent living.
DESIGN
Single arm pre/post clinical trial.
SUBJECTS
Adults (≥65 years of age) with self-identified chronic pain (≥3 on a 10-point scale, lasting for ≥3 months) and no current yoga practice.
INTERVENTION
Ten weekly 60-min gentle yoga classes tailored to elderly adults.
OUTCOME MEASURES
At baseline, weeks 5, 10 (end of intervention), and 20 (follow-up), we collected data on feasibility (adherence, retention, safety), pain, anxiety, depression, fatigue, sleep disturbance, and physical function.
RESULTS
Twenty-six participants enrolled (88% women, 77% white, 58% in assisted living) with average age of 86.6 ± 4.4 (Mean, STD). Twenty participants completed the intervention, with 90% adhering (completing ≥6 classes). Nine participants (45% of completers) experienced adverse events, which were non-serious and related to transient musculoskeletal pain. No adverse events resulted in study withdrawal. Participants reported being somewhat likely to recommend yoga to a friend, and quite a bit likely to do yoga again. At the end of the intervention, four of twenty participants reported practicing yoga outside of class. Anxiety significantly decreased from 5.80 (SE=0.90) to 4.44 (SE=0.74) (p = 0.014), but there were no changes in other measures.
CONCLUSIONS
Our pilot 10-week yoga study was generally safe for and suitable to assisted and independent living elderly adults. Future studies are needed to examine other effects of yoga in assisted/independent living adults with chronic pain.",2020,"Nine participants (45% of completers) experienced adverse events, which were non-serious and related to transient musculoskeletal pain.","['elders in assisted and independent living', 'Twenty participants completed the intervention, with 90% adhering (completing ≥6 classes', 'Twenty-six participants enrolled (88% women, 77% white, 58% in assisted living) with average age of 86.6\xa0±\xa04.4 (Mean, STD', 'living elderly adults', 'elderly adults', 'Adults (≥65 years of age) with self-identified chronic pain (≥3 on a 10-point scale, lasting for ≥3 months) and no current yoga practice', 'elderly adults in assisted and independent living', 'living adults with chronic pain', 'elders ≥65 years']","['gentle yoga', 'modified yoga program']","['feasibility (adherence, retention, safety), pain, anxiety, depression, fatigue, sleep disturbance, and physical function', 'transient musculoskeletal pain', 'Anxiety', 'adverse events', 'quality of life']","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0021189', 'cui_str': 'Independent Living'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",26.0,0.0863089,"Nine participants (45% of completers) experienced adverse events, which were non-serious and related to transient musculoskeletal pain.","[{'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Boehnke', 'Affiliation': 'Anesthesiology Department, University of Michigan Medical School, Ann Arbor, MI 48105, United States; Chronic Pain and Fatigue Research Center, University of Michigan Medical School, Ann Arbor, MI, United States. Electronic address: kboehnke@med.umich.edu.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'LaMore', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Hart', 'Affiliation': 'Every Body Happy Yoga and Healing Center, United States.'}, {'ForeName': 'Suzanna M', 'Initials': 'SM', 'LastName': 'Zick', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States; Department of Nutritional Sciences, University of Michigan School of Public Health, Ann Arbor, MI, United States.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.11.010']
2936,33257214,Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease.,"INTRODUCTION AND OBJECTIVES
Economic studies may help decision making in the management of multivessel disease in the setting of myocardial infarction. We sought to perform an economic evaluation of CROSS-AMI (Complete Revascularization or Stress Echocardiography in Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction) randomized clinical trial.
METHODS
We performed a cost minimization analysis for the strategies (complete angiographic revascularization [ComR] and selective stress echocardiography-guided revascularization [SelR]) compared in the CROSS-AMI clinical trial (N=306), attributable the initial hospitalization and readmissions during the first year of follow-up, using current rates for health services provided by our health system.
RESULTS
The index hospitalization costs were higher in the ComR group than in SelR arm (19 657.9±6236.8 € vs 14 038.7±4958.5 €; P <.001). There were no differences in the costs of the first year of follow-up rehospitalizations between both groups for (ComR 2423.5±4568.0 vs SelR 2653.9±5709.1; P=.697). Total cost was 22 081.3±7505.6 for the ComR arm and 16 692.6±7669.9 for the SelR group (P <.001).
CONCLUSIONS
In the CROSS-AMI trial, the initial extra economic costs of the ComR versus SelR were not offset by significant savings during follow-up. SelR seems to be more efficient than ComR in patients with ST-segment elevation acute coronary syndrome and multivessel disease treated by emergent angioplasty. Study registred at ClinicalTrial.gov (Identifier: NCT01179126).",2020,There were no differences in the costs of the first year of follow-up rehospitalizations between both groups for (ComR 2423.5±4568.0 vs SelR 2653.9±5709.1; P=.697).,"['patients with ST-segment elevation acute coronary syndrome and multivessel disease treated by emergent angioplasty', 'Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction']","['CROSS-AMI (Complete Revascularization or Stress Echocardiography', 'angiographic revascularization [ComR] and selective stress echocardiography-guided revascularization [SelR', 'complete revascularization versus stress echocardiography-guided revascularization']","['Total cost', 'costs of the first year of follow-up rehospitalizations', 'index hospitalization costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}]","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0920208', 'cui_str': 'Stress echocardiogram'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",306.0,0.0479992,There were no differences in the costs of the first year of follow-up rehospitalizations between both groups for (ComR 2423.5±4568.0 vs SelR 2653.9±5709.1; P=.697).,"[{'ForeName': 'Xacobe', 'Initials': 'X', 'LastName': 'Flores-Ríos', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain. Electronic address: xacobeflores@yahoo.es.'}, {'ForeName': 'Ramón A', 'Initials': 'RA', 'LastName': 'Calviño-Santos', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Estévez-Loureiro', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Hospital Universitario Álvaro Cunqueiro, Vigo, Pontevedra, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Peteiro-Vázquez', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Salgado-Fernández', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Rodríguez-Vilela', 'Affiliation': 'Servicio de Cardiología, Complexo Hospitalario Universitario Arquitecto Marcide, Ferrol, A Coruña, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Franco-Gutiérrez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bouzas-Mosquera', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'José Ángel', 'Initials': 'JÁ', 'LastName': 'Rodríguez-Fernández', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Marzoa-Rivas', 'Affiliation': 'Servicio de Cardiología, Complexo Hospitalario Universitario Arquitecto Marcide, Ferrol, A Coruña, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'González-Juanatey', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Aldama-López', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Piñón-Esteban', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Vázquez-González', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Muñiz-García', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain; Departamento de Ciencias de la Salud, Universidad de A Coruña, A Coruña, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Vázquez-Rodríguez', 'Affiliation': 'Unidad de Hemodinámica, Servicio de Cardiología, Instituto de Investigación Biomédica de A Coruña (INIBIC), Complejo Hospitalario Universitario de A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Spain.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.09.028']
2937,33257178,Differential impact on men in an IPV prevention intervention: A post hoc analysis using latent class analysis of the Stepping Stones and Creating Futures intervention in South Africa.,"Working with men to prevent their perpetration of intimate partner violence and non-partner sexual violence is increasingly recognised as effective. However, in any given context there are a multiplicity of masculinities, each of which has a different association with violence perpetration. There remains lack of clarity about whether such interventions impact all men and masculinities equally. We undertook a post-hoc analysis of men involved in the successful Stepping Stones and Creating Futures cluster randomized control trial in Durban, South Africa, to assess: i) whether there were different groups of men, ii) the factors associated with group allocation, and iii) whether the intervention had a differential impact on these groups in terms of violence perpetration. We used Latent Class Analysis (LCA) to identify masculinity classes, based on fit statistics and theoretical plausibility, and then used descriptive statistics (numbers, percentages, means) and p-values and multinomial models (95% confidence intervals, p-values) to assess factors associated with allocation to each class. To assess intervention impact by group, we used an intention-to-treat analysis, comparing men in each masculinity class, by intervention and control arm, using generalized estimating equations reporting unadjusted and adjusted odds ratios (aORs). In total 674 were recruited at baseline, and the LCA identified three classes of men: high violence (29% of men), medium violence (50% of men) and low violence (21% of men). Multinomial models showed those in more violent classes were more supportive of violence, had more adverse experiences, more depression and had worked more. By masculinity class, the impact of SS-CF showed reductions among the most violent men, with significant reductions in past year physical IPV (aOR0.59, p = 0.014), emotional IPV (aOR0.44, p = 0.044) and economic IPV (aOR0.35, p = 0.004), with non-significant reductions among other classes of men. This analysis suggests intensive group-based interventions can have significant impacts on the most violent men in communities.",2020,Working with men to prevent their perpetration of intimate partner violence and non-partner sexual violence is increasingly recognised as effective.,"['Working with men to prevent their perpetration of intimate partner violence and non-partner sexual violence', 'South Africa', 'men involved in the successful Stepping Stones and Creating Futures cluster randomized control trial in Durban, South Africa', 'In total 674 were recruited at baseline, and the LCA identified three classes of men: high violence (29% of men), medium violence (50% of men) and low violence (21% of men', 'men in an IPV prevention intervention']",[],"['economic IPV', 'emotional IPV ', 'past year physical IPV']","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036056', 'cui_str': 'St. Lucia'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",674.0,0.089076,Working with men to prevent their perpetration of intimate partner violence and non-partner sexual violence is increasingly recognised as effective.,"[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gibbs', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Private Bag x385, 0001, Pretoria, South Africa; Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, 4th Floor, George Campbell Building West Wing, Howard College Campus, Durban, South Africa. Electronic address: andrew.gibbs@mrc.ac.za.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Abdelatif', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, PO Box 70380, 4091 Overport, Durban, South Africa. Electronic address: nada.abdelatif@mrc.ac.za.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Washington', 'Affiliation': 'Project Empower, 20 Diakonia Ave, Durban Central, Durban, 4001, South Africa. Electronic address: laura@projectempower.co.za.'}, {'ForeName': 'Esnat', 'Initials': 'E', 'LastName': 'Chirwa', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Private Bag x385, 0001, Pretoria, South Africa; School of Public Health, University of Witwatersrand, 60 York Rd, Parktown, Johannesburg, 2193, South Africa. Electronic address: Esnat.chirwa@mrc.ac.za.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Willan', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Private Bag x385, 0001, Pretoria, South Africa. Electronic address: Samantha.willan@mrc.ac.za.'}, {'ForeName': 'Nwabisa', 'Initials': 'N', 'LastName': 'Shai', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Private Bag x385, 0001, Pretoria, South Africa; School of Public Health, University of Witwatersrand, 60 York Rd, Parktown, Johannesburg, 2193, South Africa. Electronic address: Nwabisa.shai@mrc.ac.za.'}, {'ForeName': 'Yandisa', 'Initials': 'Y', 'LastName': 'Sikweyiya', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Private Bag x385, 0001, Pretoria, South Africa; School of Public Health, University of Witwatersrand, 60 York Rd, Parktown, Johannesburg, 2193, South Africa. Electronic address: Yandisa.sikweyiya@mrc.ac.za.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jewkes', 'Affiliation': 'Gender and Health Research Unit, South African Medical Research Council, Private Bag x385, 0001, Pretoria, South Africa; School of Public Health, University of Witwatersrand, 60 York Rd, Parktown, Johannesburg, 2193, South Africa; Office of the Executive Scientist, South African Medical Research Council, Pretoria, South Africa Private Bag x385, 0001 Pretoria, South Africa. Electronic address: rachel.jewkes@mrc.ac.za.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113538']
2938,33257162,The effect of a digital training tool to aid chest image interpretation: Hybridising eye tracking technology and a decision support tool.,"INTRODUCTION
Eye tracking technology, checklists and search strategies have been demonstrated as useful aids in image interpretation. A training tool was developed, by the research team, which included these features. This study aimed to evaluate the effect of the training tool on participant image interpretation performance.
METHODS
The study was carried out with reporting radiographers who had either commenced training in chest image interpretation (n = 12) or were trained in musculoskeletal image interpretation (n = 23) (total n = 35). Participants were allocated to a control or intervention group. Participants completed an initial assessment at recruitment and re-attended nine months later for a follow-up assessment. The intervention group were given unlimited access to a digital training tool. During assessments participants interpreted 20 chest images whilst using eye tracking technology (total of 1400 images were interpreted). A confidence level was obtained from participants on their diagnosis and a questionnaire, to obtain demographic data, was completed following the assessment.
RESULTS
Improvements were seen in the confidence of intervention group participants (p < 0.05). False Positive (FP) scores decreased for both the control and intervention group (p < 0.05), this decrease was from 4.20 to 3.20 for the control group and from 5.87 to 3.27 for the intervention group. True Negative (TN) scores increased, from 5.13 to 6.73 for the intervention group (p < 0.05). Mean decision time decreased for both the control and intervention group.
CONCLUSION
The tool led to positive effects on participant performance and could be a useful aid in chest image interpretation learning.
IMPLICATIONS FOR PRACTICE
Improvements in performance were observed with a digital tool. The tool could improve image interpretation methods and training.",2020,"False Positive (FP) scores decreased for both the control and intervention group (p < 0.05), this decrease was from 4.20 to 3.20 for the control group and from 5.87 to 3.27 for the intervention group.",['reporting radiographers who had either commenced training in chest image interpretation (n\xa0=\xa012) or were'],"['unlimited access to a digital training tool', 'trained in musculoskeletal image interpretation', 'digital training tool to aid chest image interpretation']","['False Positive (FP) scores', 'True Negative (TN) scores', 'Mean decision time']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0402007', 'cui_str': 'Medical radiographer'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0560179', 'cui_str': 'Imaging interpretation'}]","[{'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0560179', 'cui_str': 'Imaging interpretation'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205560', 'cui_str': 'True negative'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",1400.0,0.0524461,"False Positive (FP) scores decreased for both the control and intervention group (p < 0.05), this decrease was from 4.20 to 3.20 for the control group and from 5.87 to 3.27 for the intervention group.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'McLaughlin', 'Affiliation': 'Centre for Health and Rehabilitation Technologies, Institute of Nursing and Health, School of Health Sciences, Ulster University, Northern Ireland, United Kingdom. Electronic address: lm.mclaughlin@ulster.ac.uk.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health and Rehabilitation Technologies, Institute of Nursing and Health, School of Health Sciences, Ulster University, Northern Ireland, United Kingdom. Electronic address: cm.hughes@ulster.ac.uk.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bond', 'Affiliation': 'Computer Science Research Institute, School of Computing and Mathematics, Ulster University, Northern Ireland, United Kingdom. Electronic address: rb.bond@ulster.ac.uk.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McConnell', 'Affiliation': 'Queen Elizabeth University Hospital, NHS Greater Glasgow and Clyde, Scotland, United Kingdom. Electronic address: jonathan.mcconnell@ggc.scot.nhs.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cairns', 'Affiliation': 'Computer Science Research Institute, School of Computing and Mathematics, Ulster University, Northern Ireland, United Kingdom. Electronic address: cairns-a3@ulster.ac.uk.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'McFadden', 'Affiliation': 'Centre for Health and Rehabilitation Technologies, Institute of Nursing and Health, School of Health Sciences, Ulster University, Northern Ireland, United Kingdom. Electronic address: s.mcfadden@ulster.ac.uk.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2020.11.002']
2939,33257104,Adjustments for oral fluid quality and collection methods improve prediction of circulating tetanus antitoxin: Approaches for correcting antibody concentrations detected in a non-invasive specimen.,"OBJECTIVES
To examine whether anti-tetanus toxoid (anti-TT) immunoglobulin G (IgG) levels measured in oral fluid and adjusted for collection difficulties and specimen quality are associated with total IgG and anti-TTIgG in oral fluid and assess if statistical adjustment for them improves prediction of anti-TT IgG in serum.
METHODS
267 children, ages 12 to 15 months, enrolled in the M-SIMU randomized controlled trial participated in this nested cross-sectional analysis. Venous blood and oral fluid (OF) specimens were collected, and OF collection difficulties such as crying or gagging were recorded. OF volume was documented and total IgG was measured in OF specimens and anti-TT IgG was measured in OF and serum by enzyme immunoassay (EIA). Collection difficulties, volume and sociodemographic characteristics were assessed in relation to total IgG and anti-TT IgG in OF via multivariate regression. These models were extended to evaluate the association between anti-TT IgG in OF and in serum. A prediction model was developed to adjust anti-TT IgG in OF estimates as proxy for serum.
RESULTS
Blood in the specimen, sores in the mouth and crying were positively associated with total IgG concentration while high oral fluid volume and sucking on the swab were inversely associated. None were significant predictors of anti-TT IgG in OF after adjusting for total IgG (geometric mean [GM] ratio: 1.99; 95% confidence interval: 1.78-2.24) and vaccination history (GM ratio: 2.44; 95% CI: 1.98-3.01). When predicting anti-TT IgG levels in serum with OF, total IgG modified the effect of anti-TT IgG in OF.
CONCLUSIONS
Anti-TT IgG in OF is a good proxy for levels in serum, after controlling for total IgG in the specimen and other variables. Post hoc adjustments for OF volume and total IgG concentration are an important consideration when conducting serosurveys with oral fluid.",2020,None were significant predictors of anti-TT IgG in OF after adjusting for total IgG (geometric mean [GM] ratio: 1.99; 95% confidence interval: 1.78-2.24) and vaccination history (GM ratio: 2.44; 95% CI: 1.98-3.01).,"['267 children, ages 12 to 15\xa0months, enrolled in the M-SIMU randomized controlled trial participated in this nested cross-sectional analysis']",['anti-tetanus toxoid (anti-TT) immunoglobulin G (IgG'],"['OF volume and total IgG concentration', 'Collection difficulties, volume and sociodemographic characteristics', 'total IgG', 'Venous blood and oral fluid (OF) specimens', 'total IgG concentration']","[{'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}]","[{'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0449971', 'cui_str': 'Volume of fluid used'}, {'cui': 'C0428539', 'cui_str': 'Total immunoglobulin measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",267.0,0.0846469,None were significant predictors of anti-TT IgG in OF after adjusting for total IgG (geometric mean [GM] ratio: 1.99; 95% confidence interval: 1.78-2.24) and vaccination history (GM ratio: 2.44; 95% CI: 1.98-3.01).,"[{'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Garrison-Desany', 'Affiliation': 'International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Benard Omondi', 'Initials': 'BO', 'LastName': 'Ochieng', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.'}, {'ForeName': 'Maurice R', 'Initials': 'MR', 'LastName': 'Odiere', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Kuo', 'Affiliation': 'International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Dustin G', 'Initials': 'DG', 'LastName': 'Gibson', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Were', 'Affiliation': 'Centre for Global Health Research, Kenya Medical Research Institute (KEMRI), Kisumu, Kenya.'}, {'ForeName': 'E Wangeci', 'Initials': 'EW', 'LastName': 'Kagucia', 'Affiliation': 'International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Marcela F', 'Initials': 'MF', 'LastName': 'Pasetti', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Global Health, Bill & Melinda Gates Foundation, Seattle, WA, USA.'}, {'ForeName': 'Mardi', 'Initials': 'M', 'LastName': 'Reymann', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': ""O'Brien"", 'Affiliation': 'International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kyla', 'Initials': 'K', 'LastName': 'Hayford', 'Affiliation': 'International Vaccine Access Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: kylahayford@jhu.edu.'}]",Vaccine,['10.1016/j.vaccine.2020.11.027']
2940,33256795,"Evaluation of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, and inflammatory and antioxidant biomarkers in overweight or obese prediabetic patients: a study protocol for a randomized double-blind placebo-controlled phase 2 clinical trial.","BACKGROUND
The prevalence of prediabetes is increasing worldwide. Unfortunately, prediabetes is related to non-communicable diseases. A high risk of developing type 2 diabetes mellitus (T2DM) is reported in people with prediabetes. Curcumin, a polyphenol, might lead to its therapeutic role in obesity and some obesity-related metabolic diseases. Zinc is a trace element that plays a key role in the synthesis and action of insulin, carbohydrate metabolism, and decreasing inflammation. There has been no clinical trial of zinc and curcumin co-supplementation in patients with prediabetes. In previous studies, the single administration of zinc or curcumin has not been conducted on many of the studied markers in prediabetic patients.
METHODS
The purpose of this randomized double-blind placebo-controlled clinical trial is to investigate the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, and inflammatory and antioxidant biomarkers among 84 prediabetic patients with body mass index (BMI) between 25 and 35. Also, liver enzyme, serum zinc, urine zinc, blood pressure, anthropometric parameters, quality of life, adherence to co-supplementation, the side effects of co-supplementation, physical activity, and dietary intake will be assessed. Women or men (18-50 years old for men and 18 years to before menopause for women) will be followed for 3 months (90 days). This study will be conducted at Yazd Diabetes Research Clinic, Shahid Sadoughi University of Medical Sciences.
DISCUSSION
A diet rich in antioxidants, polyphenols, and phytochemicals has been shown to have a beneficial role in prediabetes. According to the beneficial properties of curcumin or zinc and inadequate evidence, RCTs are needed to assess the effect of curcumin and zinc co-supplementation in native prediabetes patients. We hope the results of the present trial, negative or positive, fill this gap in the literature and facilitate the approach for a much larger, multi-center clinical trial. In conclusion, a synergic effect of co-supplementation along with a weight-loss diet may delay the progression to type 2 diabetes mellitus.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials (IRCT) IRCT20190902044671N1 . Registered on 11 October 2019.",2020,"Also, liver enzyme, serum zinc, urine zinc, blood pressure, anthropometric parameters, quality of life, adherence to co-supplementation, the side effects of co-supplementation, physical activity, and dietary intake will be assessed.","['patients with prediabetes', 'prediabetic patients', 'overweight or obese prediabetic patients', 'native prediabetes patients', 'Women or men (18-50\u2009years old for men and 18\u2009years to before menopause for women', '84 prediabetic patients with body mass index (BMI) between 25 and 35']","['curcumin and zinc co-supplementation', 'placebo']","['glycemic measurements, lipid profiles, and inflammatory and antioxidant biomarkers', 'liver enzyme, serum zinc, urine zinc, blood pressure, anthropometric parameters, quality of life, adherence to co-supplementation, the side effects of co-supplementation, physical activity, and dietary intake']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0587111', 'cui_str': 'Before menopause'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0856205', 'cui_str': 'Serum zinc'}, {'cui': 'C0428572', 'cui_str': 'Zinc measurement, urine'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",84.0,0.438139,"Also, liver enzyme, serum zinc, urine zinc, blood pressure, anthropometric parameters, quality of life, adherence to co-supplementation, the side effects of co-supplementation, physical activity, and dietary intake will be assessed.","[{'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Karandish', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Mozaffari-Khosravi', 'Affiliation': 'Department of Nutrition, School of Public Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Mohammadi', 'Affiliation': 'School of Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Azhdari', 'Affiliation': 'Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. azhdari_mar@yahoo.com.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Cheraghian', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health Sciences, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Trials,['10.1186/s13063-020-04923-w']
2941,33256794,Comparison of GlideScope™ visualization and neck flexion with lateral neck pressure nasogastric tube insertion techniques in anesthetized patients: a randomized clinical study.,"OBJECTIVE
Nasogastric tube (NGT) insertion in anesthetized and intubated patients can be challenging, even for experienced anesthesiologists. Various techniques have been proposed to facilitate NGT insertion in these patients. This study aimed to compare the success rate and time required for NGT insertion between GlideScope™ visualization and neck flexion, with lateral neck pressure techniques.
MATERIAL AND METHODS
This randomized clinical trial was performed at a teaching hospital on 86 adult patients undergoing abdominal surgery, under relaxant general anesthesia, who required intraoperative NGT insertion. The patients were randomized into two groups, the GlideScope™ group (group G) and the neck flexion with lateral neck pressure group (group F). The success rate of the first and second attempts, duration of insertion, and complications were recorded.
RESULTS
The total success rate was 79.1% in group G, compared with 76.7% in group F (P = 1). The median time required for NGT insertion was significantly longer in group G, for both first and second attempts (97 vs 42 s P < 0.001) and (70 vs 48.5 s P = 0.015), respectively. Complications were reported in 23 patients (53.5%) in group G and 13 patients (30.2%) in group F. Bleeding and kinking were the most common complications for both techniques.
CONCLUSION
Using GlideScope™ visualization to facilitate NGT insertion was comparable to neck flexion with lateral neck pressure technique, in the degree of success rates of insertion. Although complications were not statistically significant between groups, neck flexion with lateral neck pressure technique was significantly less time-consuming for both first and second attempts.
TRIAL REGISTRATION
Retrospectively registered: Thai Clinical Trial Registry (TCTR)20171229003 . Registered on 19 December 2017.",2020,"Although complications were not statistically significant between groups, neck flexion with lateral neck pressure technique was significantly less time-consuming for both first and second attempts.
","['86 adult patients undergoing abdominal surgery, under relaxant general anesthesia, who required intraoperative NGT insertion', 'anesthetized patients', 'anesthetized and intubated patients']","['GlideScope™ group (group G) and the neck flexion with lateral neck pressure group', 'GlideScope™ visualization and neck flexion with lateral neck pressure nasogastric tube insertion techniques', 'Nasogastric tube (NGT) insertion']","['neck flexion with lateral neck pressure technique', 'success rate of the first and second attempts, duration of insertion, and complications', 'Complications', 'total success rate', 'median time required for NGT insertion']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441841', 'cui_str': 'Group G'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204819', 'cui_str': 'Insertion of nasogastric tube'}]",86.0,0.0959906,"Although complications were not statistically significant between groups, neck flexion with lateral neck pressure technique was significantly less time-consuming for both first and second attempts.
","[{'ForeName': 'Pitchaporn', 'Initials': 'P', 'LastName': 'Purngpipattrakul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Suttasinee', 'Initials': 'S', 'LastName': 'Petsakul', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, 90110, Thailand. p.suttasinee@gmail.com.'}, {'ForeName': 'Sunisa', 'Initials': 'S', 'LastName': 'Chatmonkolchart', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Kanjana', 'Initials': 'K', 'LastName': 'Nuanjun', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, 90110, Thailand.'}, {'ForeName': 'Somrutai', 'Initials': 'S', 'LastName': 'Boonchuduang', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hatyai, Songkhla, 90110, Thailand.'}]",Trials,['10.1186/s13063-020-04911-0']
2942,33256760,Serum surfactant protein D as a predictive biomarker for the efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis: a post-hoc analysis of the phase 3 trial in Japan.,"BACKGROUND
Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal disorder with a variable disease course. The recent advancement of antifibrotic therapy has increased the need for reliable and specific biomarkers. This study aimed to assess alveolar epithelial biomarkers as predictors for the efficacy of the antifibrotic drug pirfenidone.
METHODS
We conducted a post-hoc analysis of the prospective, multicenter, randomized, placebo-controlled, phase 3 trial of pirfenidone in Japan (total, n = 267; pirfenidone, n = 163; placebo, n = 104). Logistic regression analysis was performed to extract parameters that predicted disease progression, defined by a ≥ 10% relative decline in vital capacity (VC) from baseline and/or death, at week 52. For assessment of serum surfactant protein (SP)-D, SP-A and Krebs von den Lungen (KL)-6, all patients were dichotomized by the median concentration of each biomarker at baseline to the high and low biomarker subgroups. Associations of these concentrations were examined with changes in VC at each time point from baseline up to week 52, along with progression-free survival (PFS). Additionally, the effect of pirfenidone treatment on serial longitudinal concentrations of these biomarkers were evaluated.
RESULTS
In the multivariate logistic regression analysis, body mass index (BMI), %VC and SP-D in the pirfenidone group, and BMI and %VC in the placebo group were indicated as predictors of disease progression. Pirfenidone treatment reduced the decline in VC with statistical significance in the low SP-D and low SP-A subgroups over most of the treatment period, and also prolonged PFS in the low SP-D and low KL-6 subgroups. Furthermore, SP-D levels over time course were reduced in the pirfenidone group from as early as week 8 until the 52-week treatment period compared with the placebo group.
CONCLUSIONS
Serum SP-D was the most consistent biomarker for the efficacy of pirfenidone in the cohort trial of IPF. Serial measurements of SP-D might have a potential for application as a pharmacodynamic biomarker. Trial registration The clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13, 2005 (registration No. JapicCTI-050121; http://Clinicaltrials.jp ).",2020,"Pirfenidone treatment reduced the decline in VC with statistical significance in the low SP-D and low SP-A subgroups over most of the treatment period, and also prolonged PFS in the low SP-D and low KL-6 subgroups.","['patients with idiopathic pulmonary fibrosis', 'in Japan (total, n\u2009=\u2009267; pirfenidone, n\u2009=\u2009163; placebo, n\u2009=\u2009104']","['pirfenidone', 'placebo', 'Pirfenidone']","['body mass index (BMI), %VC and SP-D', 'Furthermore, SP-D levels over time course', 'serum surfactant protein (SP)-D, SP-A and Krebs von', 'disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3544277', 'cui_str': 'Surfactant protein'}, {'cui': 'C0143146', 'cui_str': 'SP-A Protein'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0544713,"Pirfenidone treatment reduced the decline in VC with statistical significance in the low SP-D and low SP-A subgroups over most of the treatment period, and also prolonged PFS in the low SP-D and low KL-6 subgroups.","[{'ForeName': 'Kimiyuki', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Respiratory Medicine and Allergology, School of Medicine, Sapporo Medical University, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Chiba', 'Affiliation': 'Department of Respiratory Medicine and Allergology, School of Medicine, Sapporo Medical University, South 1, West 16, Sapporo, 060-8543, Japan. hchiba@sapmed.ac.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Nishikiori', 'Affiliation': 'Department of Respiratory Medicine and Allergology, School of Medicine, Sapporo Medical University, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kondoh', 'Affiliation': 'Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Taguchi', 'Affiliation': 'Tenri Hospital, Tenri, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ebina', 'Affiliation': 'Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Sakaguchi', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Miyazawa', 'Affiliation': 'Shionogi & Co., Ltd, Osaka, Japan.'}, {'ForeName': 'Moritaka', 'Initials': 'M', 'LastName': 'Suga', 'Affiliation': 'Saiseikai Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Sugiyama', 'Affiliation': 'Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Nukiwa', 'Affiliation': 'Tohoku University, Sendai, Japan.'}, {'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Kudoh', 'Affiliation': 'Japan Anti-Tuberculosis Association, Tokyo, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Respiratory Medicine and Allergology, School of Medicine, Sapporo Medical University, South 1, West 16, Sapporo, 060-8543, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory research,['10.1186/s12931-020-01582-y']
2943,33256753,A physical activity coaching intervention can improve and maintain physical activity and health-related outcomes in adult ambulatory hospital patients: the Healthy4U-2 randomised controlled trial.,"BACKGROUND
The Healthy 4 U-2 study sought to evaluate the effect of a twelve-week, physical activity (PA) coaching intervention for changes and maintenance in PA, anthropometrics and health-related outcomes in adults presenting to an ambulatory hospital clinic.
METHODS
One hundred and twenty insufficiently active adults were recruited from an ambulatory hospital clinic and randomised to an intervention group that received an education session and five 20-min telephone sessions of PA coaching, or to a control group that received the education session only. ActiGraph GT3X accelerometers were used to measure moderate-to-vigorous physical activity (MVPA) at baseline, post-intervention (3-months) and follow-up (9-months). Secondary outcome measures (anthropometrics, PA self-efficacy, and health-related quality of life) were also assessed at the three time points.
RESULTS
At baseline, the mean age and body mass index of participants were 53 ± 8 years and 31 ± 4 kg/m 2 , respectively. Relative to control, the intervention group increased objectively measured MVPA at post-intervention (p < 0.001) and 9 months follow-up (p < 0.001). At the 9-month follow-up the intervention group completed 22 min/day of MVPA (95% CI: 20 to 25 min/day), which is sufficient to meet the recommended PA guidelines. The intervention group exhibited beneficial changes in body mass (p < 0.001), waist circumference (p < 0.001), body mass index (p < 0.001), PA self-efficacy (p < 0.001), and health-related quality of life (p < 0.001) at the 9-month follow-up.
CONCLUSIONS
This study demonstrates that a low contact PA coaching intervention results in beneficial changes in PA, anthropometrics and health-related outcomes in insufficiently active adults presenting to an ambulatory care clinic. The significant beneficial changes were measured at post-intervention and the 9-month follow-up, demonstrating a maintenance effect of the intervention.
TRIAL REGISTRATION
Prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, Trial registration number: ACTRN12619000036112 .",2020,"Relative to control, the intervention group increased objectively measured MVPA at post-intervention (p < 0.001) and 9 months follow-up (p < 0.001).","['adult ambulatory hospital patients', 'insufficiently active adults presenting to an ambulatory care clinic', 'One hundred and twenty insufficiently active adults were recruited from an ambulatory hospital clinic', 'adults presenting to an ambulatory hospital clinic']","['physical activity coaching intervention', 'low contact PA coaching intervention', 'MVPA', 'physical activity (PA) coaching intervention', 'education session and five 20-min telephone sessions of PA coaching, or to a control group that received the education session only']","['PA self-efficacy', 'anthropometrics, PA self-efficacy,\xa0and health-related quality of life', 'beneficial changes in body mass', 'objectively measured MVPA', 'body mass index', 'health-related quality of life', 'waist circumference']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",120.0,0.107607,"Relative to control, the intervention group increased objectively measured MVPA at post-intervention (p < 0.001) and 9 months follow-up (p < 0.001).","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barrett', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, PO Box 199, Bendigo, Victoria, 3552, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Begg', 'Affiliation': 'La Trobe Rural Health School, La Trobe University, PO Box 199, Bendigo, Victoria, 3552, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Halloran"", 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Bundoora, Victoria, 3068, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kingsley', 'Affiliation': 'Holsworth Research Initiative, La Trobe Rural Health School, La Trobe University, PO Box 199, Bendigo, Victoria, 3552, Australia. M.Kingsley@latrobe.edu.au.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01063-x']
2944,33256737,Understanding the influence of physical resources and social supports on primary food providers' snack food provision: a discrete choice experiment.,"BACKGROUND
Snack eating occasions contribute approximately a third of children's energy intake, with approximately half of all unhealthy foods consumed during snack times. Therefore, it is critical to understand the drivers of primary food providers' snack provision. The study aims were to determine the relative importance of physical resources and social supports when primary food providers are choosing snacks to provide to their child, and to investigate how these attributes differ in social versus non-social occasions, and between subgroups of primary food providers based on socio-economic position.
METHODS
Primary food providers of three to seven-year olds completed an online discrete choice experiment, by making trade-offs when completing repeated, hypothetical choice tasks on the choice of snacks to provide to their child in: 1) non-social and 2) social condition. Choice tasks included two alternatives consisting of varying attribute (i.e. factor) levels, and an opt-out option. The order of conditions shown were randomized across participants. Multinomial logit model analyses were used to determine utility weights for each attribute.
RESULTS
Two-hundred and twenty-five primary food providers completed the study, providing 1125 choice decisions per condition. In the non-social condition, the top three ranked attributes were type of food (utility weight 1.94, p < 0.001), child resistance (- 1.62, p < 0.001) and co-parent support (0.99, p < 0.001). In the social condition, top ranking attributes were child resistance (utility weight - 1.50, p < 0.001), type of food (1.38, p < 0.001) and co-parent support (1.07, p < 0.001). In both conditions, time was not a significant influence and cost was of lowest relative importance. Subgroup analyses revealed cost was not a significant influence for families from higher socio-economic backgrounds.
CONCLUSIONS
Type of food, child resistance and co-parent support were of greatest relative importance in primary food providers' snack provision decision-making, regardless of social condition or socio-economic position. In designing future interventions to reduce unhealthy snacks, researchers should prioritize these influences, to better support primary food providers in changing their physical and social opportunity.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry no. ACTR N12618001173280.",2020,"In the social condition, top ranking attributes were child resistance (utility weight - 1.50, p < 0.001), type of food (1.38, p < 0.001) and co-parent support (1.07, p < 0.001).","['Two-hundred and twenty-five primary food providers completed the study, providing 1125 choice decisions per condition', 'Primary food providers of three to seven-year olds completed an']","['online discrete choice experiment, by making trade-offs when completing repeated, hypothetical choice tasks on the choice of snacks to provide to their child in: 1) non-social and 2) social condition']",['child resistance'],"[{'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1518543', 'cui_str': 'Off'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0037403', 'cui_str': 'Social Conditions'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",2.0,0.0488862,"In the social condition, top ranking attributes were child resistance (utility weight - 1.50, p < 0.001), type of food (1.38, p < 0.001) and co-parent support (1.07, p < 0.001).","[{'ForeName': 'Brittany J', 'Initials': 'BJ', 'LastName': 'Johnson', 'Affiliation': 'Caring Futures Institute, College of Nursing & Health Sciences, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia. brittany.johnson@flinders.edu.au.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Golley', 'Affiliation': 'Caring Futures Institute, College of Nursing & Health Sciences, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Zarnowiecki', 'Affiliation': 'Caring Futures Institute, College of Nursing & Health Sciences, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia.'}, {'ForeName': 'Gilly A', 'Initials': 'GA', 'LastName': 'Hendrie', 'Affiliation': 'Health & Biosecurity Flagship, Commonwealth Scientific Industrial Research Organisation, Adelaide, South Australia, Australia.'}, {'ForeName': 'Elisabeth K', 'Initials': 'EK', 'LastName': 'Huynh', 'Affiliation': 'Department of Health Services Research and Policy, Research School of Population Health, Australian National University, Acton, Australian Capital Territory, Australia.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01062-y']
2945,33256727,"Visual arts in the clinical clerkship: a pilot cluster-randomized, controlled trial.","BACKGROUND
Arts exposure is associated with positive psychological constructs. To date, no randomized, controlled studies have integrated art into clinical medical education or measured its effects on positive psychological constructs or educational outcomes. In this study, we assessed the possibility and potential benefits of integrating visual arts education into a required internal medicine (IM) clinical clerkship.
METHODS
We conducted a controlled trial in an academic healthcare system with an affiliated art museum. IM students were assigned to one of three interventions: museum-based arts (n = 11), hospital-based arts (n = 10), or hospital-based conventional education (n = 13). Arts groups explored empathy, resilience, and compassion in works of art during facilitator-guided discussions. We assessed pre- and post-intervention measures of empathy, mindfulness, tolerance of ambiguity, and grit and tracked National Board of Medical Examiners IM shelf exam performance to capture changes in educational outcomes. Focus group discussions with participants in the arts-based interventions were performed at the study's conclusion.
RESULTS
Arts education was successfully integrated into a busy clinical clerkship in both hospital and art museum settings. Focus group participants reported increased implicit bias cognizance and time for reflection, but no significant differences in psychometric or educational outcomes were identified. While most students felt positively toward the experience; some experienced distress from missed clinical time.
CONCLUSIONS
This pilot study demonstrates the feasibility of integrating visual arts education into the clerkship. Although observable quantitative differences in measures of positive psychological constructs and educational outcomes were not found, qualitative assessment suggested benefits as well as the feasibility of bringing fine arts instruction into the clinical space. A larger, multi-center study is warranted.",2020,"Focus group participants reported increased implicit bias cognizance and time for reflection, but no significant differences in psychometric or educational outcomes were identified.","['IM students', 'academic healthcare system with an affiliated art museum']","['hospital-based arts (n\xa0=\u200910), or hospital-based conventional education']","['empathy, mindfulness, tolerance of ambiguity, and grit and tracked National Board of Medical Examiners IM shelf exam performance', 'implicit bias cognizance and time for reflection', 'psychometric or educational outcomes']","[{'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0026863', 'cui_str': 'Museum'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0440273', 'cui_str': 'Grit'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0025082', 'cui_str': 'Medical Examiner'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.099289,"Focus group participants reported increased implicit bias cognizance and time for reflection, but no significant differences in psychometric or educational outcomes were identified.","[{'ForeName': 'Garth W', 'Initials': 'GW', 'LastName': 'Strohbehn', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Stephanie J K', 'Initials': 'SJK', 'LastName': 'Hoffman', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Tokaz', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Houchens', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Slavin', 'Affiliation': 'University of Michigan Museum of Art, Ann Arbor, MI, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Winter', 'Affiliation': 'Division of Hospital Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Quinn', 'Affiliation': 'Patient Safety Enhancement Program, University of Michigan and Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ratz', 'Affiliation': 'Patient Safety Enhancement Program, University of Michigan and Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Saint', 'Affiliation': 'Medicine Service, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Chopra', 'Affiliation': 'Medicine Service, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, USA.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Howell', 'Affiliation': 'Medical Arts Program, University of Michigan Medical School, Ann Arbor, MI, USA. jhowell@umich.edu.'}]",BMC medical education,['10.1186/s12909-020-02386-w']
2946,33256697,"Improvement of Parent's awareness, knowledge, perception, and acceptability of human papillomavirus vaccination after a structured-educational intervention.","BACKGROUND
Regardless of the disease burden of human papillomavirus (HPV), the vaccine has not been included in the Indonesia National Immunization Program. Since 2017 there was a demonstration program of the HPV vaccination in Yogyakarta Province. This vaccine was given free to female primary school students in the 5th and 6th grades (11-13 years old). This study aimed to assess whether a structured-educational intervention focus on HPV increases the parental awareness, knowledge, and perceptions toward HPV and the vaccine acceptability.
METHODS
We conducted a pre-post structured-educational intervention study from July to August 2017 before the implementation of the HPV vaccination demonstration program, in Kulon Progo District, Yogyakarta Province, Indonesia. Parents of female primary school students grades 5th and 6th were selected using a school-based proportional random sampling. A pediatric resident provided a structured-educational intervention, which consists of the burden and risk of HPV disease, as well as the benefit and safety of the vaccine. Parents were required to complete validated self-administered questionnaires before and after the structured-educational intervention.
RESULTS
A total of 506 parents participated. Before receiving the structured-educational intervention, parents' awareness of HPV infection and the vaccines were low. Only 49.2% of parents had heard HPV infection, and 48.8% had heard about the vaccine. After the structured-educational intervention, there were significant improvements in parent's awareness, knowledge, and perceptions of HPV infection, cervical cancer, and HPV vaccination (all p < 0.001). HPV vaccine's acceptability increased from 74.3 to 87.4% (p < 0.001). There was a significant correlation between increasing HPV vaccine acceptability with the improvement of awareness, knowledge, and perception toward HPV infection, cervical cancer and HPV vaccination (r = 0.32 to 0.53, p < 0.001). After the structured-educational intervention, better knowledge and positive perceptions of HPV vaccination were predictive of HPV vaccine's acceptability with OR 1.90 (95%CI:1.40-2.57) and OR 1.31(95%CI,1.05-1.63), respectively.
CONCLUSIONS
A structured-educational intervention may improve parental awareness, knowledge, and perceptions toward HPV and the acceptability of the vaccine. Further study, a randomized control trial with longer follow-up are needed to evaluate the long-term and actual effectiveness of improving parents' knowledge, perceptions and HPV vaccine acceptability.",2020,HPV vaccine's acceptability increased from 74.3 to 87.4% (p < 0.001).,"['female primary school students in the 5th and 6th grades (11-13\u2009years old', 'July to August 2017 before the implementation of the HPV vaccination demonstration program, in Kulon Progo District, Yogyakarta Province, Indonesia', '506 parents participated', 'Parents of female primary school students grades 5th and 6th were selected using a school-based proportional random sampling']",['structured-educational intervention'],"['HPV vaccine acceptability', 'heard HPV infection', ""HPV vaccine's acceptability"", 'parental awareness, knowledge, and perceptions toward HPV and the vaccine acceptability', ""Improvement of Parent's awareness, knowledge, perception, and acceptability of human papillomavirus vaccination"", 'awareness, knowledge, and perception toward HPV infection, cervical cancer and HPV vaccination', ""parent's awareness, knowledge, and perceptions of HPV infection, cervical cancer, and HPV vaccination"", ""parents' knowledge, perceptions and HPV vaccine acceptability"", 'parental awareness, knowledge, and perceptions toward HPV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",506.0,0.0754533,HPV vaccine's acceptability increased from 74.3 to 87.4% (p < 0.001).,"[{'ForeName': 'Mei Neni', 'Initials': 'MN', 'LastName': 'Sitaresmi', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/ DR. Sardjito Hospital, Jalan Gejayan CT X no 18 Pelemkecut, Yogyakarta, 55281, Indonesia. msitaresmi@ugm.ac.id.'}, {'ForeName': 'Nisrina Maulida', 'Initials': 'NM', 'LastName': 'Rozanti', 'Affiliation': 'School of Medicine, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Lamria Besty', 'Initials': 'LB', 'LastName': 'Simangunsong', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada/ DR. Sardjito Hospital, Jalan Gejayan CT X no 18 Pelemkecut, Yogyakarta, 55281, Indonesia.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Wahab', 'Affiliation': 'Department of Biostatistics, Epidemiology and Population Health, Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}]",BMC public health,['10.1186/s12889-020-09962-1']
2947,33256694,Effects of a movement control and tactile acuity training in patients with nonspecific chronic low back pain and control impairment - a randomised controlled pilot study.,"BACKGROUND
Nonspecific chronic low back pain (NSCLBP) is a heterogeneous condition that is associated with complex neuromuscular adaptations. Exercise is a widely administered treatment, but its effects are small to moderate. Tailoring patient-specific exercise treatments based on subgroup classification may improve patient outcomes.
OBJECTIVE
In this randomised controlled pilot study, our objective was to compare the feasibility and possible effects of a specific sensorimotor treatment (SMT) with those of a general exercise (GE) programme on patients with NSCLBP and control impairment (CI).
METHODS
Patients with NSCLBP and CI were randomised into an SMT or a GE programme spanning 6 sessions each. The feasibility criteria included the study design, assessments, interventions and magnitudes of effects, and costs. Adverse events were documented. Primary (pain, physical function, and quality of life) and secondary outcomes were assessed three times: twice at baseline (t1a and t1b) to estimate parameter stability and once after the intervention (t2).
RESULTS
Two-hundred and twenty-seven patients were screened to include 34 participants with NSCLBP and CI. Both treatment programmes and the assessments seemed feasible because their durations and contents were perceived as adequate. The total cost per participant was €321. Two adverse events occurred (one not likely related to the SMT, one likely related to the GE intervention). The SMT showed a tendency for superior effects in terms of pain severity (SMT t1a 3.5, t2 1.1; GE t1a 3.0, t2 2.0), pain interference (SMT t1a 1.9, t2 0.4; GE t1a 1.5, t2 0.9), physical component of quality of life (SMT t1a 39, t2 46; GE t1a 45, t2 48), and movement control.
CONCLUSIONS
The SMT approach proposed in this study is feasible and should be tested thoroughly in future studies, possibly as an addition to GE. To ensure the detection of differences in pain severity between SMT and GE in patients with NSCLBP with 80% power, future studies should include 110 patients. If the current results are confirmed, SMT should be considered in interventions for patients with NSCLBP and CI.
TRIAL REGISTRATION
Registered in the German Register for Clinical Trials (Trial registration date: November 11, 2016; Trial registration number: DRKS00011063 ; URL of trial registry record); retrospectively registered.",2020,"The SMT showed a tendency for superior effects in terms of pain severity (SMT t1a 3.5, t2 1.1; GE t1a 3.0, t2 2.0), pain interference (SMT t1a 1.9, t2 0.4; GE t1a 1.5, t2 0.9), physical component of quality of life (SMT t1a 39, t2 46; GE t1a 45, t2 48), and movement control.
","['patients with NSCLBP and control impairment (CI', 'patients with NSCLBP and CI', 'Patients with NSCLBP and CI', 'Two-hundred and twenty-seven patients were screened to include 34 participants with NSCLBP and CI', 'Nonspecific chronic low back pain (NSCLBP', 'patients with nonspecific chronic low back pain and control impairment ']","['SMT', 'specific sensorimotor treatment (SMT', 'movement control and tactile acuity training', 'general exercise (GE) programme']","['pain severity', 'physical component of quality of life', 'pain interference', 'Adverse events', 'Primary (pain, physical function, and quality of life) and secondary outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",34.0,0.196251,"The SMT showed a tendency for superior effects in terms of pain severity (SMT t1a 3.5, t2 1.1; GE t1a 3.0, t2 2.0), pain interference (SMT t1a 1.9, t2 0.4; GE t1a 1.5, t2 0.9), physical component of quality of life (SMT t1a 39, t2 46; GE t1a 45, t2 48), and movement control.
","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'van Baal', 'Affiliation': 'Department of Applied Health Sciences, University of Applied Sciences Bochum, Gesundheitscampus 6-8, 44801, Bochum, Germany. vanbaal.katharina@mh-hannover.de.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Allofs', 'Affiliation': 'Department of Applied Health Sciences, University of Applied Sciences Bochum, Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Ehrenbrusthoff', 'Affiliation': 'Department of Applied Health Sciences, University of Applied Sciences Bochum, Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grüneberg', 'Affiliation': 'Department of Applied Health Sciences, University of Applied Sciences Bochum, Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hering', 'Affiliation': 'Department of Applied Health Sciences, University of Applied Sciences Bochum, Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kopkow', 'Affiliation': 'Department of Applied Health Sciences, University of Applied Sciences Bochum, Gesundheitscampus 6-8, 44801, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiel', 'Affiliation': 'Department of Applied Health Sciences, University of Applied Sciences Bochum, Gesundheitscampus 6-8, 44801, Bochum, Germany.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03727-y']
2948,33256688,Public knowledge of risk factors and warning signs for cardiovascular disease among young and middle-aged adults in rural Tanzania.,"BACKGROUND
Improving cardiovascular health requires public knowledge and reduction of modifiable cardiovascular disease (CVD) risk factors. This study assessed knowledge of risk factors and warning signs for CVDs among young and middle-aged adults in Morogoro, Tanzania.
METHODS
We conducted a community-based survey as part of cluster randomized controlled study of community health workers (CHWs) intervention for reduction of blood pressure among young and middle-aged adults in rural Morogoro. Information on socio-demographic characteristics, knowledge of risk factors and warning signs for CVDs was collected using an interviewer administered questionaire. Knowledge was assessed using open-ended questions followed by closed-ended questions. Descriptive statistics were used to describe knowledge of risk factors and warning signs. Logistic regression analysis was used to investigate factors associated with adequate knowledge of risk factors and warning signs for CVDs.
RESULTS
Two-thirds (65.7%) of the participants had heard about CVDs. The main sources of information were mainly relatives/ neighbors (64.8%) and radio (53.0%). Only 28.3% of the participants reported health care providers as source of information about CVDs. More than half of the participants (52.4%) did not mention even one risk factor spontaneously while 55.2% were unable to mention any warning sign. When asked to select from a list, 6.9% were unable to correctly identify any risk factor whereas 11.8% could not correctly identify even a single warning sign. Quarter of participants (25.4%) had good knowledge score of risk factors, 17.5% had good knowledge score of warning signs and 16.3% had overall good knowledge of both risk factors and warning signs. Residing in Ulanga, having higher education level, having ever checked blood pressure and being overweight/obese predicted adequacy of knowledge score for both risk factors and warning signs.
CONCLUSION
Knowledge of risk factors and warning signs in this rural population of young and middle-aged adults was generally low. Health care providers were less likely to provide health education regarding risk factors and warning signs for CVDs. Health promotion interventions to increase population knowledge of risk factors and warning signs should be implemented for successful reduction of CVDs in Tanzania.",2020,Health promotion interventions to increase population knowledge of risk factors and warning signs should be implemented for successful reduction of CVDs in Tanzania.,"['young and middle-aged adults in rural Morogoro', 'rural population of young and middle-aged adults', 'young and middle-aged adults in Morogoro, Tanzania', 'young and middle-aged adults in rural Tanzania']","['Health promotion interventions', 'community health workers (CHWs) intervention']","['good knowledge score of warning signs', 'socio-demographic characteristics, knowledge of risk factors and warning signs for CVDs', 'good knowledge score of risk factors', 'overall good knowledge of both risk factors and warning signs', 'blood pressure']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035962', 'cui_str': 'Rural Population'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0193534,Health promotion interventions to increase population knowledge of risk factors and warning signs should be implemented for successful reduction of CVDs in Tanzania.,"[{'ForeName': 'Alfa J', 'Initials': 'AJ', 'LastName': 'Muhihi', 'Affiliation': 'Department of Community Health, Muhimbili University of Health and Allied Sciences, United Nations Road, P. O. Box 65001, Upanga, Dar es Salaam, Tanzania. selukundo@gmail.com.'}, {'ForeName': 'Amani', 'Initials': 'A', 'LastName': 'Anaeli', 'Affiliation': 'Department of Development Studies, Muhimbili University of Health and Allied Sciences, United Nations Road, Upanga, Dar es Salaam, Tanzania.'}, {'ForeName': 'Rose N M', 'Initials': 'RNM', 'LastName': 'Mpembeni', 'Affiliation': 'Department of Epidemiology and Biostatistics, Muhimbili University of Health and Allied Sciences, United Nations Road, Upanga, Dar es Salaam, Tanzania.'}, {'ForeName': 'Bruno F', 'Initials': 'BF', 'LastName': 'Sunguya', 'Affiliation': 'Department of Community Health, Muhimbili University of Health and Allied Sciences, United Nations Road, P. O. Box 65001, Upanga, Dar es Salaam, Tanzania.'}, {'ForeName': 'Germana', 'Initials': 'G', 'LastName': 'Leyna', 'Affiliation': 'Department of Epidemiology and Biostatistics, Muhimbili University of Health and Allied Sciences, United Nations Road, Upanga, Dar es Salaam, Tanzania.'}, {'ForeName': 'Deodatus', 'Initials': 'D', 'LastName': 'Kakoko', 'Affiliation': 'Department of Behavioral Sciences, Muhimbili University of Health and Allied Sciences, United Nations Road, Upanga, Dar es Salaam, Tanzania.'}, {'ForeName': 'Anna Tengia', 'Initials': 'AT', 'LastName': 'Kessy', 'Affiliation': 'Department of Community Health, Muhimbili University of Health and Allied Sciences, United Nations Road, P. O. Box 65001, Upanga, Dar es Salaam, Tanzania.'}, {'ForeName': 'Mary Mwanyika', 'Initials': 'MM', 'LastName': 'Sando', 'Affiliation': 'Africa Academy for Public Health, Plot # 802, Mwai Kibaki Road, Mikocheni, Dar es Salaam, Tanzania.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Njelekela', 'Affiliation': 'Department of Physiology, Muhimbili University of Health and Allied Sciences, United Nations Road, Upanga, Dar es Salaam, Tanzania.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Urassa', 'Affiliation': 'Department of Community Health, Muhimbili University of Health and Allied Sciences, United Nations Road, P. O. Box 65001, Upanga, Dar es Salaam, Tanzania.'}]",BMC public health,['10.1186/s12889-020-09956-z']
2949,33256683,Influence of motivation and a new digitized training program on undergraduate dental students during preclinical scaling training.,"BACKGROUND
The current study evaluated whether a new digitized scaling training program (DTP: n = 30; supervisor-student-ratio 1:10) improves the performance of undergraduate dental student during a preclinical course in regard to two different instruments [sonic scalers (AIR) and Gracey curettes (GRA)] compared to a conventional training program (CTP: n = 19; supervisor-student-ratio 1:4).
METHODS
All the participants received a two-hour lecture on both instruments, followed by a 12-week period with a weekly training program lasting 45 min (10 sessions); one group was supported by DTP. At the end of the training phase, all the participants performed the subgingival scaling of six equivalent test teeth using GRA and AIR. Treatment time, proportion of removed simulated biofilm (relative cleaning efficacy, RCE-b) and hard deposits (RCE-d) were recorded. By using a pseudonymized questionnaire with a 5-point Likert scale, self-assessment of scaling effort, handling, root surface roughness/destruction and effectiveness were evaluated. In addition, personal data such as age, gender, handedness, regularity of playing computer games/consoles and previous dental/technical or medical education were elevated and correlated with cleaning efficacy.
RESULTS
The DTP participants showed higher effectiveness in RCE-b compared to those who used the CTP with GRA (71.54% vs. 67.23%, p = 0.004) and AIR (71.75% vs. 62.63%, p ≤ 0.001), and the DTP students were faster with both instruments (p ≤ 0.001). For RCE-d, there was no significant difference between the DTP and CTP groups (GRA p = 0.471; AIR p = 0.158), whereas DTP showed better RCE-d results with GRA versus AIR (84.68% vs. 77.85%, p < 0.001). According to the questionnaire, no significant differences were detected between the training groups in terms of self-assessment, handling, treatment time, root surface roughness/destruction or effectiveness of the instruments. The CTP group favored AIR compared to GRA regarding the fatigue effect. The CTP and playing computer games/consoles regularly was correlated with lower RCE-b, whereas previous education in medicine/dentistry was correlated with higher RCE-b values.
CONCLUSIONS
Within the limitations of the study, the DTP with a reduced supervision effort compared to the CTP resulted in higher effectiveness and lower instrumentation time for removing simulated biofilms.",2020,"According to the questionnaire, no significant differences were detected between the training groups in terms of self-assessment, handling, treatment time, root surface roughness/destruction or effectiveness of the instruments.",['undergraduate dental students during preclinical scaling training'],"['motivation and a new digitized training program', 'conventional training program (CTP: n\u2009=\u200919; supervisor-student-ratio 1:4', 'instruments [sonic scalers (AIR) and Gracey curettes (GRA', 'CTP', 'GRA', 'new digitized scaling training program (DTP: n\u2009=\u200930; supervisor-student-ratio 1:10']","['5-point Likert scale, self-assessment of scaling effort, handling, root surface roughness/destruction and effectiveness', 'Treatment time, proportion of removed simulated biofilm (relative cleaning efficacy, RCE-b) and hard deposits (RCE-d', 'self-assessment, handling, treatment time, root surface roughness/destruction or effectiveness of the instruments', 'AIR', 'fatigue effect']","[{'cui': 'C0038493', 'cui_str': 'Dental Student'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0684254', 'cui_str': 'Dental scaler'}, {'cui': 'C0180236', 'cui_str': 'Curette'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0150704,"According to the questionnaire, no significant differences were detected between the training groups in terms of self-assessment, handling, treatment time, root surface roughness/destruction or effectiveness of the instruments.","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Seidel', 'Affiliation': 'Clinic of Conservative Dentistry and Periodontology, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Sutor', 'Affiliation': 'Clinic of Conservative Dentistry and Periodontology, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Conrad', 'Affiliation': 'Clinic of Conservative Dentistry and Periodontology, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Engel', 'Affiliation': 'Clinic of Conservative Dentistry and Periodontology, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Geiken', 'Affiliation': 'Clinic of Conservative Dentistry and Periodontology, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Sälzer', 'Affiliation': 'Clinic of Conservative Dentistry and Periodontology, University of Kiel, Kiel, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Graetz', 'Affiliation': 'Clinic of Conservative Dentistry and Periodontology, University of Kiel, Kiel, Germany. graetz@konspar.uni-kiel.de.'}]",BMC oral health,['10.1186/s12903-020-01343-9']
2950,33256659,"The safety and efficacy of transcranial direct current stimulation as add-on therapy to fluoxetine in obsessive-compulsive disorder: a randomized, double-blind, sham-controlled, clinical trial.","BACKGROUND
Obsessive-compulsive disorder (OCD) is an anxiety disorder that causes impairment in daily activities. This study aimed to assess the safety and efficacy of transcranial direct current stimulation (tDCS) as adjunctive therapy with fluoxetine in individuals diagnosed with moderate to severe OCD.
METHODS
This is a randomized, double-blind sham-controlled trial. Individuals with OCD who had baseline Yale-Brown obsessive-compulsive scale (Y-BOCS) of > 15 were enrolled. Eligible cases were randomly assigned in 1:1 ratio to receive either 20-min-period of stimulation with tDCS and fluoxetine (experimental arm) or fluoxetine only (sham control arm). The anodal electrode of tDCS was placed over the left dorsolateral prefrontal cortex (Fp3) and the cathodal electrode was placed over the right orbitofrontal cortex (F8). Two mA electrical stimulation with the tDCS was used for 20 min in individuals of experimental group. In the control group, electrodes were placed and stimulation was administered for 30 s to induce the same skin sensation as in experimental group. This procedure was performed three times per week for 8 weeks. Y-BOCS test was assessed at baseline, week 4 (after 12th stimulation), week 8 (after 24th stimulation), and 1 month after the last stimulation. The primary endpoints were the mean changes in Y-BOCS total score from baseline to the last visit. The secondary endpoints were the mean changes in obsession and compulsion sub-scores from baseline to the last visit. Adverse events were also assessed. Mixed design repeated measures analysis of variance assessed the endpoints.
RESULTS
Sixty individuals (30 in each group) were participated. All individuals in control group and 28 cases in experimental arm completed the trial. The mean Y-BOCS (F (1.85) = 30.83; P < 0.001), OCD obsession (F (2.23) = 25.01; P < 0.001), and compulsion (F (2.06) = 10.81; P < 0.001) scores decreased significantly during the study. No statistical differences were, however, detected between experimental and control groups (P > 0.05). The tDCS was well tolerated and no major adverse events were reported.
CONCLUSION
This study showed that among individuals with moderate to severe OCD, there was no significant difference regarding OC symptoms between cases used tDCS as adjunctive therapy with fluoxetine and individuals used fluoxetine only.
TRIAL REGISTRATION
IRCT2017030632904N1 . Registered 14 July 2017, http://irct.ir/user/trial/44193/view.",2020,"The mean Y-BOCS (F (1.85) = 30.83; P < 0.001), OCD obsession (F (2.23) = 25.01; P < 0.001), and compulsion (F (2.06) = 10.81;","['Individuals with OCD who had baseline Yale-Brown obsessive-compulsive scale (Y-BOCS) of >\u200915 were enrolled', 'individuals diagnosed with moderate to severe OCD', 'individuals with moderate to severe OCD', 'obsessive-compulsive disorder', 'Sixty individuals (30 in each group) were participated', 'Eligible cases']","['transcranial direct current stimulation (tDCS', 'fluoxetine', 'tDCS and fluoxetine (experimental arm) or fluoxetine', 'transcranial direct current stimulation']","['tolerated and no major adverse events', 'safety and efficacy', 'mean changes in Y-BOCS total score', 'OC symptoms', 'mean changes in obsession and compulsion sub-scores', 'Adverse events', 'mean Y-BOCS', 'OCD obsession']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C0600104', 'cui_str': 'Compulsive behavior'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",15.0,0.0915506,"The mean Y-BOCS (F (1.85) = 30.83; P < 0.001), OCD obsession (F (2.23) = 25.01; P < 0.001), and compulsion (F (2.06) = 10.81;","[{'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Yoosefee', 'Affiliation': 'Neurosciences Research Center, Qom University of Medical Sciences, Qom, Iran.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Amanat', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': ""Faculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.""}, {'ForeName': 'Seyed Vahid', 'Initials': 'SV', 'LastName': 'Mousavi', 'Affiliation': 'NeuroImmunology Research Association (NIRA), Universal Scientific Education and Research Network (USERN), Tehran, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Behzadmanesh', 'Affiliation': 'Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Safary', 'Affiliation': 'Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yoonesi', 'Affiliation': 'Department of Neurosciences, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Salehi', 'Affiliation': 'Department of Psychiatry, Arak University of Medical Sciences, Arak, Iran. Basalehi@yahoo.com.'}]",BMC psychiatry,['10.1186/s12888-020-02979-1']
2951,33256621,Randomized clinical trial to compare efficacy and safety of repeated courses of rituximab to single-course rituximab followed by maintenance mycophenolate-mofetil in children with steroid dependent nephrotic syndrome.,"BACKGROUND
Approximately 30% of children with idiopathic nephrotic syndrome develop a complicated course with frequent relapses or steroid dependency. Rituximab, a B cell depleting monoclonal antibody, is a safe and effective alternative to steroids or other immunosuppressants for achieving and maintaining remission in this population at short term. Despite the good initial response relapses inevitably occur after regeneration of B lymphocytes, necessitating either repeat courses of rituximab or addition of another steroid-sparing immunosuppressant.
METHODS
This is a prospective, single-center, open-label, two-parallel-arm randomized controlled phase III study among children with steroid dependent nephrotic syndrome who are maintained in remission with oral steroids. One hundred children will be randomized to either Rituximab and maintenance Mycophenolate mofetil (A) or repeated courses of prophylactic Rituximab only (B). In arm A, mycophenolate mofetil (1200 mg/m 2 per day) will be started 3 months after Rituximab administration. In arm B, Rituximab infusions will be administered at 0, 8 and 16 months if B cell count normalize at the given time points. Prednisolone will be discontinued in both groups 2 weeks following first course of rituximab. Primary aim is to evaluate the difference in 24-month relapse-free survival. Main secondary endpoints are cumulative prednisolone dose, frequency of relapses and changes in anthropometry. Circulating B lymphocyte populations will be studied as biomarkers or predictors of rituximab responsiveness and adverse events will be analysed.
DISCUSSION
The study will provide evidence as to the comparative safety and efficacy of two alternative steroid-sparing therapeutic options in children suffering from steroid dependent nephrotic syndrome. The two-year study design will address the long-term results obtained with the alternative treatment protocols.
TRIAL REGISTRATION
This trial was prospectively registered to the Clinicaltrial.gov ( NCT03899103 dated 02/04/2019; https://clinicaltrials.gov/ ) and Clinical Trials Registry of India ( CTRI/2019/04/018517 dated 09/04/2019).",2020,"Rituximab, a B cell depleting monoclonal antibody, is a safe and effective alternative to steroids or other immunosuppressants for achieving and maintaining remission in this population at short term.","['children suffering from steroid dependent nephrotic syndrome', 'children with idiopathic nephrotic syndrome', 'children with steroid dependent nephrotic syndrome', 'One hundred children', 'children with steroid dependent nephrotic syndrome who are maintained in remission with oral steroids']","['Prednisolone', 'mycophenolate-mofetil', 'steroid-sparing therapeutic options', 'rituximab to single-course rituximab', 'mycophenolate mofetil', 'rituximab', 'Rituximab and maintenance Mycophenolate mofetil (A) or repeated courses of prophylactic Rituximab', 'Rituximab']","['cumulative prednisolone dose, frequency of relapses and changes in anthropometry', 'efficacy and safety', '24-month relapse-free survival']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0403398', 'cui_str': 'Steroid-dependent nephrotic syndrome'}, {'cui': 'C1704321', 'cui_str': 'Minimal Change Nephrotic Syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",100.0,0.092879,"Rituximab, a B cell depleting monoclonal antibody, is a safe and effective alternative to steroids or other immunosuppressants for achieving and maintaining remission in this population at short term.","[{'ForeName': 'Biswanath', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics, Nilratan Sircar Medical College & Hospital, Kolkata, West Bengal, 700014, India. basuv3000@gmail.com.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Preussler', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Sander', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, Im Neuenheimer Feld 130.3, 69120, Heidelberg, Germany.'}, {'ForeName': 'T K S', 'Initials': 'TKS', 'LastName': 'Mahapatra', 'Affiliation': 'Department of Pediatrics, Nilratan Sircar Medical College & Hospital, Kolkata, West Bengal, 700014, India.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Schaefer', 'Affiliation': 'Division of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, University of Heidelberg, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany. franz.schaefer@med.uni-heidelberg.de.'}]",BMC nephrology,['10.1186/s12882-020-02153-5']
2952,33256614,Increased biological relevance of transcriptome analyses in human skeletal muscle using a model-specific pipeline.,"BACKGROUND
Human skeletal muscle responds to weight-bearing exercise with significant inter-individual differences. Investigation of transcriptome responses could improve our understanding of this variation. However, this requires bioinformatic pipelines to be established and evaluated in study-specific contexts. Skeletal muscle subjected to mechanical stress, such as through resistance training (RT), accumulates RNA due to increased ribosomal biogenesis. When a fixed amount of total-RNA is used for RNA-seq library preparations, mRNA counts are thus assessed in different amounts of tissue, potentially invalidating subsequent conclusions. The purpose of this study was to establish a bioinformatic pipeline specific for analysis of RNA-seq data from skeletal muscles, to explore the effects of different normalization strategies and to identify genes responding to RT in a volume-dependent manner (moderate vs. low volume). To this end, we analyzed RNA-seq data derived from a twelve-week RT intervention, wherein 25 participants performed both low- and moderate-volume leg RT, allocated to the two legs in a randomized manner. Bilateral muscle biopsies were sampled from m. vastus lateralis before and after the intervention, as well as before and after the fifth training session (Week 2).
RESULT
Bioinformatic tools were selected based on read quality, observed gene counts, methodological variation between paired observations, and correlations between mRNA abundance and protein expression of myosin heavy chain family proteins. Different normalization strategies were compared to account for global changes in RNA to tissue ratio. After accounting for the amounts of muscle tissue used in library preparation, global mRNA expression increased by 43-53%. At Week 2, this was accompanied by dose-dependent increases for 21 genes in rested-state muscle, most of which were related to the extracellular matrix. In contrast, at Week 12, no readily explainable dose-dependencies were observed. Instead, traditional normalization and non-normalized models resulted in counterintuitive reverse dose-dependency for many genes. Overall, training led to robust transcriptome changes, with the number of differentially expressed genes ranging from 603 to 5110, varying with time point and normalization strategy.
CONCLUSION
Optimized selection of bioinformatic tools increases the biological relevance of transcriptome analyses from resistance-trained skeletal muscle. Moreover, normalization procedures need to account for global changes in rRNA and mRNA abundance.",2020,"Overall, training led to robust transcriptome changes, with the number of differentially expressed genes ranging from 603 to 5110, varying with time point and normalization strategy.
",[],[],['global mRNA expression'],[],[],"[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",25.0,0.0249641,"Overall, training led to robust transcriptome changes, with the number of differentially expressed genes ranging from 603 to 5110, varying with time point and normalization strategy.
","[{'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Khan', 'Affiliation': 'Department of Biotechnology, Inland Norway University of Applied Sciences, Holsetgata 22, 2317, Hamar, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hammarström', 'Affiliation': 'Section for Health and Exercise Physiology, Department of Public Health and Sport Sciences, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Section for Health and Exercise Physiology, Department of Public Health and Sport Sciences, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Ellefsen', 'Affiliation': 'Section for Health and Exercise Physiology, Department of Public Health and Sport Sciences, Inland Norway University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Rafi', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Department of Biotechnology, Inland Norway University of Applied Sciences, Holsetgata 22, 2317, Hamar, Norway. rafi.ahmad@inn.no.'}]",BMC bioinformatics,['10.1186/s12859-020-03866-y']
2953,33256506,"Effects of Breviscapine and C3435T MDR1 gene polymorphism on the pharmacokinetics of fexofenadine, a P-glycoprotein substrate, in healthy volunteers.","Breviscapine is usually used for long-term use in patients with cardiovascular diseases such as coronary heart disease, angina pectoris, and cerebral thrombosis. It is possible to combine it with P-glycoprotein (P-gp) substrates in clinic. At present, little is known about whether the simultaneous use of BRE affects the disposal of P-gp substrates. The aim of this study was to evaluate the effect of BRE on the pharmacokinetics of fexofenadine, a P-gp probe substrate and its associations with the MDR1 C3435T genetic polymorphism in healthy volunteers. In this randomized, open-label, placebo-controlled, two-phase crossover clinical study, drug interactions were evaluated in healthy volunteers. FEX was used as a phenotypic probe for P-gp. In each phase, eighteen volunteers were given daily doses of 120 mg (40 mg, three times a day) of BRE tablet or a placebo for 14 days. On day 15, a single oral dose of 120 mg FEX hydrochloride was given orally. Blood samples were collected at predefined time intervals, and plasma levels of FEX were determined by UHPLC-MS/MS. The pharmacokinetic parameters were calculated by non-compartmental method, and bioequivalence was evaluated. Results showed that BRE pretreatment did not significantly affect the pharmacokinetics of FEX. The peak maximum plasma concentration (C max ) and the area under the plasma concentration-time curve from zero to infinity (AUC inf ) mean value of FEX with BRE and placebo-treated groups were 699 ng/mL vs 710 ng/mL and 2972.5 ng⋅h/mL vs 3460.5 ng⋅h/mL, respectively. The geometric mean ratios (90% confidence intervals) for FEX C max and AUC inf were within the pre-specified range of 0.8-1.25, indicating that FEX in the two pretreatment phases were bioequivalent. Pharmacokinetic parameters of FEX showed no statistically significant difference between MDR1 C3435T CC, CT and TT genotype, revealing that BRE and MDR1 C3435T gene polymorphisms did not affect the pharmacokinetics of FEX in healthy volunteers.",2020,"Pharmacokinetic parameters of FEX showed no statistically significant difference between MDR1 C3435T CC, CT and TT genotype, revealing that BRE and MDR1 C3435T gene polymorphisms did not affect the pharmacokinetics of FEX in healthy volunteers.","['patients with cardiovascular diseases such as coronary heart disease, angina pectoris, and cerebral thrombosis', 'healthy volunteers']","['Breviscapine and C3435T MDR1', 'fexofenadine', 'BRE', 'Breviscapine', 'placebo', 'FEX', 'FEX hydrochloride', 'BRE tablet or a placebo']","['peak maximum plasma concentration (C max ) and the area under the plasma concentration-time curve', 'pharmacokinetics of FEX', 'FEX C max and AUC inf', 'geometric mean ratios', 'plasma levels of FEX']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0079102', 'cui_str': 'Cerebral thrombosis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0054048', 'cui_str': 'breviscapine'}, {'cui': 'C0296800', 'cui_str': 'fexofenadine'}, {'cui': 'C0574305', 'cui_str': 'Breton language'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",18.0,0.0574184,"Pharmacokinetic parameters of FEX showed no statistically significant difference between MDR1 C3435T CC, CT and TT genotype, revealing that BRE and MDR1 C3435T gene polymorphisms did not affect the pharmacokinetics of FEX in healthy volunteers.","[{'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Yingying', 'Affiliation': 'Dali University, Pharmacology, Dali, 671000 China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Zhimin', 'Affiliation': 'Dali University, Dali, 671000 China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Mingzhao', 'Affiliation': 'Dali University, Pharmacology, Dali, 671000 China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Dali University, Department of Pharmacology, College of Pharmacy, Dali, 671000 China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lai', 'Affiliation': 'Dali University, Department of Pharmacology, College of Pharmacy, Dali, 671000 China.'}]",Xenobiotica; the fate of foreign compounds in biological systems,['10.1080/00498254.2020.1857467']
2954,33256485,Cost-minimisation Analysis from a Non-inferiority Trial of Ready-Made versus Custom-Made Spectacles for School Children in India.,"Purpose: Uncorrected refractive error is the leading cause of visual impairment in children. Many countries, including India, implement school eye health programmes involving vision screening and provision of free spectacles. This is costly for governments/organisations involved. This analysis estimates potential cost-savings if ready-made spectacles, in addition to traditional custom-made spectacles, are available for dispensing in school eye health programmes. Methods: An economic evaluation was conducted alongside a randomised controlled trial comparing spectacle wear of ready-made spectacles versus custom-made spectacles for children aged 11-15 years in schools in India. A cost-minimisation approach was used to calculate cost-savings of a 'ready-made spectacles available' programme compared with a 'custom-made spectacles only' school programme. The analysis was from a service provider perspective. Main outcomes: cost-saving per child needing spectacles and cost-saving per 1000 children screened. Results: The prevalence of uncorrected refractive error was 2.23%, and 86% of children were eligible for ready-made spectacles. The cost per child needing spectacles in a custom-made spectacles only programme was USD$26.91, and in a ready-made spectacles available programme was $11.15, producing a 58.6% cost-saving per child needing spectacles of $15.76. Considering the total cost of the eye health programme, this equated to a 15.1% cost-saving per 1000 children screened of $361. Results were robust to multivariate sensitivity analyses. Conclusion: Our study is the first to demonstrate the significant cost-saving potential of ready-made spectacles in school eye health programmes for uncorrected refractive error compared with custom-made spectacles alone. This has substantial economic benefits for national/international programmes.",2020,"This analysis estimates potential cost-savings if ready-made spectacles, in addition to traditional custom-made spectacles, are available for dispensing in school eye health programmes. ","['children', 'children aged 11-15\xa0years in schools in India', 'School Children in India']","['Ready-Made versus Custom-Made Spectacles', 'spectacle wear of ready-made spectacles versus custom-made spectacles']",['cost-saving per child needing spectacles and cost-saving per 1000 children screened'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C1277300', 'cui_str': 'Child in need'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]",,0.10095,"This analysis estimates potential cost-savings if ready-made spectacles, in addition to traditional custom-made spectacles, are available for dispensing in school eye health programmes. ","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Minakaran', 'Affiliation': 'Moorfields Eye Hospital , London, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Morjaria', 'Affiliation': 'Department of Clinical Research, London School of Hygiene & Tropical Medicine , London, UK.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Frick', 'Affiliation': 'Johns Hopkins Carey Business School , Baltimore, USA.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Gilbert', 'Affiliation': 'Department of Clinical Research, London School of Hygiene & Tropical Medicine , London, UK.'}]",Ophthalmic epidemiology,['10.1080/09286586.2020.1851728']
2955,33256456,Effects of transcutaneous electrical acupuncture point stimulation on peripheral capillary oxygen saturation in elderly patients undergoing colonoscopy with sedation: a prospective randomized controlled trial.,"INTRODUCTION
This study investigated whether transcutaneous electrical acupuncture point stimulation (TEAS) at PC6 can reduce the proportion of elderly patients experiencing a drop of ⩾4% in peripheral capillary oxygen saturation (SpO 2 ) while undergoing colonoscopy under sedation.
METHODS
A total of 32 elderly patients (aged ⩾ 65 years) scheduled for colonoscopy were randomly assigned in a 1:1 ratio to receive either real or sham TEAS (treatment or control groups, respectively). Each patient received oxygen (2 L/min) delivered routinely via nasal cannula. The treatment group was given TEAS at PC6 for 20 min at 2 Hz frequency and 6 mA intensity; the control group underwent the same procedures but with zero frequency/intensity. SpO 2 and other physiological parameters were measured prior to sedation and colonoscopy (baseline) and at seven other timepoints through departure from recovery. Depth of anesthesia was measured using a Narcotrend monitor.
RESULTS
Significantly fewer patients in the treatment group experienced a ⩾4% decrease from baseline SpO 2 (2/16) than patients in the control group (10/16; p = 0.004). The two groups were comparable with regard to respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, and heart rate.
CONCLUSION
TEAS applied at PC6 with 2 Hz frequency was feasible and may be helpful in reducing the rate of hypoxia in elderly patients during colonoscopy. Trial registration number: NCT03775122 (ClinicalTrials.gov).",2020,Significantly fewer patients in the treatment group experienced a ⩾4% decrease from baseline SpO 2 (2/16) than patients in the control group (10/16; p = 0.004).,"['elderly patients during colonoscopy', '32 elderly patients (aged\u2009⩾\u200965\u2009years) scheduled for colonoscopy', 'elderly patients experiencing a drop of ⩾4% in peripheral capillary oxygen saturation (SpO 2 ) while undergoing colonoscopy under sedation', 'elderly patients undergoing colonoscopy with sedation']","['TEAS', 'TEAS at PC6', 'transcutaneous electrical acupuncture point stimulation', 'oxygen (2\u2009L/min) delivered routinely via nasal cannula', 'real or sham TEAS', 'transcutaneous electrical acupuncture point stimulation (TEAS) at PC6']","['rate of hypoxia', 'Depth of anesthesia', 'respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, and heart rate', 'peripheral capillary oxygen saturation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0135624', 'cui_str': 'PC6 extract'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0474710', 'cui_str': 'Depth of anesthesia'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}]",32.0,0.182575,Significantly fewer patients in the treatment group experienced a ⩾4% decrease from baseline SpO 2 (2/16) than patients in the control group (10/16; p = 0.004).,"[{'ForeName': 'Yongming', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Huai', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xiyao', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Diansan', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, The Second Affiliated Hospital of Soochow University, Suzhou, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420960479']
2956,33256420,WAYS TO PERFORM AN ENDOSCOPIC TATTOO. PROSPECTIVE AND RANDOMIZED STUDY IN PATIENTS WITH COLORECTAL NEOPLASM.,"BACKGROUND AND STUDY AIMS
Intraoperative identification of colonic lesions previously detected at colonoscopy may be difficult. Endoscopic tattooing facilitates this identification, but there is no evidence regarding which is the best tattoo technique. The goal of the study was to describe the efficacy and safety of endoscopic tattooing and to detect technical and clinical factors associated with its efficacy.
PATIENTS AND METHODS
Prospective and randomized study. All tattoo candidate patients prior to surgery were included and randomized into 4 groups (tattoo at 2 or 3 injection points and with a volume of 1 or 1.5 ml of labeling). Multiple variables were registered.
RESULTS
195 patients were included in which endoscopic tattoo and subsequent surgical intervention was performed, with a mean age of 70.1 years, 67.2% being men. The laparoscopic approach was applied in 57.9% of cases. The intraoperative visibility of the endoscopic tattoo was 89.7%. 30% of rectal lesions were not visible. Excluding the rectum, the marking was visible intraoperatively in 92% of the patients without significant differences according to the surgical approach, the type of marking or any of the variables collected. The tattoo was safe in 92.3% of the cases. The adverse effect rate was 7.7%. No complications were clinically significant. There were no significant differences between any variables collected in relation to adverse effects.
CONCLUSIONS
Endoscopic colon tattoo is safe and effective regardless of the technique used. We recommend the technique of 2 injection points and 1 ml of marking volume for its simplicity, efficiency and safety.",2020,"Excluding the rectum, the marking was visible intraoperatively in 92% of the patients without significant differences according to the surgical approach, the type of marking or any of the variables collected.","['All tattoo candidate patients prior to surgery', '195 patients were included in which endoscopic tattoo and subsequent surgical intervention was performed, with a mean age of 70.1 years, 67.2% being men']",[],"['intraoperative visibility of the endoscopic tattoo', 'adverse effect rate']","[{'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0039343', 'cui_str': 'Tattooing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",195.0,0.0411421,"Excluding the rectum, the marking was visible intraoperatively in 92% of the patients without significant differences according to the surgical approach, the type of marking or any of the variables collected.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barquero Declara', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi, España.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'González Santín', 'Affiliation': 'Servicio de Cirugía General, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Orlando', 'Initials': 'O', 'LastName': 'García Bosch', 'Affiliation': 'Servicio de Aparato Digestivo, Hosppital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Fernández Simón', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Blasco Pelicano', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Navarro Llavat', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Bargalló García', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Martín Llahí', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Erice Muñoz', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Ariza Solè', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Hernández Ballesteros', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Vascónez Peña', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Unidad de Epidemiología y Estadística, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Castellví Valls', 'Affiliation': 'Servicio de Cirugía General, Hospital de Sant Joan Despí Moisès Broggi.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Mata Bilbao', 'Affiliation': 'Servicio de Aparato Digestivo, Hospital de Sant Joan Despí Moisès Broggi.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2020.7310/2020']
2957,33256419,PROSPECTIVE COMPARATIVE STUDY OF THE TREATMENT OF HELICOBACTER PYLORI WITH ANTIBIOTIC SUSCEPTIBILITY TESTING-GUIDED TRIPLE THERAPY COMPARED TO QUADRUPLE THERAPY WITH PYLERA®.,"INTRODUCTION
The current treatment indicated as first-line in the infection due to Helicobacter pylori is the quadruple therapy with bismuth (Pylera®), or the quadruple concomitant therapy without bismuth, with the triple therapy being abandoned due to its low eradication rates, partly due to an increase in antibiotic resistance. The aim of this study is to compare the Helicobacter pylori eradication rates guided by antibiotic susceptibility testing (AST) versus Pylera®.
METHODS
A specimen was taken prospectively for culture and antibiotic susceptibility testing (AST) from all patients diagnosed with Helicobacter pylori infection using gastroscopy, and they were randomised to receive triple therapy depending on the result of the AST, or quadruple therapy with Pylera®. The eradication rates of both groups were analysed using faecal antigen. The adherence and side effects of the treatment were also analysed.
RESULTS
Of the 108 patients with Helicobacter pylori infection, 55 received Pylera® and 53 AST-guided triple therapy. The eradication rates were 92.7% with Pylera® and 90.6% in the AST-guided group, with there being no statistically significant differences. There were also no differences found in adherence or side effects.
CONCLUSIONS
The treatment of Helicobacter pylori with AST-guided triple therapy is effective, especially in regions with high rates of antibiotic resistance.",2020,"The eradication rates were 92.7% with Pylera® and 90.6% in the AST-guided group, with there being no statistically significant differences.","['patients diagnosed with Helicobacter pylori infection using gastroscopy', '108 patients with Helicobacter pylori infection, 55 received Pylera® and 53 AST-guided triple therapy']","['AST-guided triple therapy', 'antibiotic susceptibility testing (AST', 'AST, or quadruple therapy with Pylera®', 'antibiotic susceptibility testing (AST) versus Pylera®', 'bismuth (Pylera®']","['adherence or side effects', 'antibiotic resistance', 'adherence and side effects', 'eradication rates', 'Helicobacter pylori eradication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1948530', 'cui_str': 'Pylera'}, {'cui': 'C0427965', 'cui_str': 'Antimicrobial susceptibility - finding'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0427965', 'cui_str': 'Antimicrobial susceptibility - finding'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C1948530', 'cui_str': 'Pylera'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",108.0,0.0178507,"The eradication rates were 92.7% with Pylera® and 90.6% in the AST-guided group, with there being no statistically significant differences.","[{'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Bonoso Criado', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pérez Citores', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Antonio Germán', 'Initials': 'AG', 'LastName': 'Pérez-Millán', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Ángela Martina', 'Initials': 'ÁM', 'LastName': 'Montero Moretón', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'González De Castro', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Cabezudo Molleda', 'Affiliation': 'Medicina Interna, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'María Antonia', 'Initials': 'MA', 'LastName': 'García Castro', 'Affiliation': 'Servicio de Microbiología, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Bruno Antonio', 'Initials': 'BA', 'LastName': 'Moreira Da Silva', 'Affiliation': 'Aparato Digestivo , Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Maestro Antolín', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santos Santamarta', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario de Palencia, España.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barcenilla Laguna', 'Affiliation': 'Aparato Digestivo, Complejo Asistencial Universitario Palencia, España.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2020.7395/2020']
2958,33256392,Ixazomib-Thalidomide-low dose dexamethasone induction followed by maintenance therapy with ixazomib or placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation; results from the randomized phase II HOVON-126/NMSG 21.13 trial.,,2020,,['newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation'],"['ixazomib or placebo', 'Ixazomib-Thalidomide-low dose dexamethasone']",[],"[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]",[],,0.0374484,,"[{'ForeName': '', 'Initials': '', 'LastName': 'Sonja Zweegman', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Claudia A M Stege', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Einar Haukas', 'Affiliation': 'Stavanger University Hospital-Rogaland Hospital, Stavanger, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Fredrik H Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Mark-David Levin', 'Affiliation': 'Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Anders Waage', 'Affiliation': 'St Olavs Hospital and Norwegian University of Science, Trondheim, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Rineke B L Leys', 'Affiliation': 'Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Saskia K Klein', 'Affiliation': 'Meander Medical Center, Amersfoort, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Damian Szatkowski', 'Affiliation': 'Førde Central Hospital, Førde, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Per Axelsson', 'Affiliation': 'Skanes University Hospital Lund, Scania, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Trung Hieu Do', 'Affiliation': 'Herlev Hospital, Herlev, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Dorota Knut-Bojanowska', 'Affiliation': 'NU-Hospital, Uddevalla Hospital, Uddevalla, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Ellen van der Spek', 'Affiliation': 'Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Asta Svirskaite', 'Affiliation': 'Aalborg Hospital, Aalborg, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Anja Klostergaard', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Morten Salomo', 'Affiliation': 'Rigshospitalet Copenhagen, Copenhagen, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Celine Blimark', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Paula F Ypma', 'Affiliation': 'Haga Hospital, Den Haag, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Ulf-Henrik Mellqvist', 'Affiliation': 'Sodra Alvsborgs Sjukhus Boras, Boras, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Pino J Poddighe', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Marian Stevens-Kroef', 'Affiliation': 'Radboud Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Niels W C J van de Donk', 'Affiliation': 'Amsterdam University Medical Center, Location VUmc, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Pieter Sonneveld', 'Affiliation': 'Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Markus Hansson', 'Affiliation': 'Skanes University Hospital Lund, Scania, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Bronno van der Holt', 'Affiliation': 'Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Niels Abildgaard', 'Affiliation': 'Department of Haematology, AgeCare, Odense University Hospital, Odense, Denmark.'}]",Haematologica,['10.3324/haematol.2019.240374']
2959,33256337,"[ Efficacy and safety of Changsulin ® compared with Lantus ® in type 2 diabetes: a phase Ⅲ multicenter, randomized, open-label, parallel, controlled clinical trial ].","Objective: To compare the efficacy and safety of Changsulin ® with Lantus ® in treating patients with type 2 diabetes mellitus (T2DM). Methods: This was a phase Ⅲ, multicenter, randomized, open-label, parallel-group, active-controlled clinical trial. A total of 578 participants with T2DM inadequately controlled on oral hypoglycemic agents were randomized 3∶1 to Changsulin ® or Lantus ® treatment for 24 weeks. The efficacy measures included changes in glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2h postprandial plasma glucose (2hPG), 8-point self-monitoring of blood glucose (SMBG) profiles from baseline, and proportions of subjects achieving targets of HbA1c and FPG. The safety outcomes included rates of hypoglycemia, adverse events (AEs) and anti-insulin glargine antibody. Results: After 24 weeks of treatment, mean HbAlc decreased 1.16% and 1.25%, FPG decreased 3.05 mmol/L and 2.90 mmol/L, 2hPG decreased 2.49 mmol/L and 2.38 mmol/L in Changsulin ® and in Lantus ® , respectively. No significant differences could be viewed in above parameters between the two groups (all P> 0.05). There were also no significant differences between Changsulin ® and Lantus ® in 8-point SMBG profiles from baseline and proportions of subjects achieving the targets of HbA1c and FPG (all P> 0.05). The rates of total hypoglycemia (38.00% and 39.01% for Changsulin ® and Lantus ® , respectively) and nocturnal hypoglycemia (17.25% and 16.31% for Changsulin ® and Lantus ® , respectively) were similar between the two groups (all P> 0.05). Most of the hypoglycemia events were asymptomatic, and no severe hypoglycemia were found in both groups. No differences were observed in rates of AEs (61.77% vs.52.48%) and anti-insulin glargine antibody (after 24 weeks of treatment, 6.91% vs.3.65%) between the two groups (all P> 0.05). Conclusions: Changsulin ® shows similar efficacy and safety profiles compared with Lantus ® and Changsulin ® treatment was well tolerated in patients with T2DM.",2020,There were also no significant differences between Changsulin ® and Lantus ® in 8-point SMBG profiles from baseline and proportions of subjects achieving the targets of HbA1c and FPG (all P> 0.05).,"['patients with T2DM', 'type 2 diabetes', '578 participants with T2DM inadequately controlled on oral hypoglycemic agents', 'patients with type 2 diabetes mellitus (T2DM']","['FPG', 'Changsulin ® or Lantus ® treatment', 'Changsulin ® with Lantus ®', 'Changsulin ®', 'Lantus ®']","['glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG), 2h postprandial plasma glucose (2hPG), 8-point self-monitoring of blood glucose (SMBG) profiles from baseline, and proportions of subjects achieving targets of HbA1c and FPG', 'anti-insulin glargine antibody', 'severe hypoglycemia', 'rates of total hypoglycemia', 'rates of AEs', 'rates of hypoglycemia, adverse events (AEs) and anti-insulin glargine antibody', 'efficacy and safety', 'nocturnal hypoglycemia', 'mean HbAlc']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0876064', 'cui_str': 'Lantus Solostar'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0342315', 'cui_str': 'Nocturnal hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",578.0,0.0263926,There were also no significant differences between Changsulin ® and Lantus ® in 8-point SMBG profiles from baseline and proportions of subjects achieving the targets of HbA1c and FPG (all P> 0.05).,"[{'ForeName': 'T T', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Harbin Medical University, Harbin 150001, China.'}, {'ForeName': 'B Y', 'Initials': 'BY', 'LastName': 'Shi', 'Affiliation': ""Department of Endocrinology, The First Affiliated Hospital of Xi'an Jiao Tong University, Xi'an 710061, China.""}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.'}, {'ForeName': 'Z H', 'Initials': 'ZH', 'LastName': 'Mo', 'Affiliation': 'Department of Endocrinology, The Third Xiangya Hospital of Central South University, Changsha 410013, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, The Second Hospital of Jilin University, Changchun 130041, China.'}, {'ForeName': 'Z Y', 'Initials': 'ZY', 'LastName': 'Shan', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang 110001, China.'}, {'ForeName': 'W Y', 'Initials': 'WY', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Q M', 'Initials': 'QM', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, PLA Rocket Force General Hospital, Beijing 100088, China.'}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Lyu', 'Affiliation': 'Department of Endocrinology, PLA Army General Hospital, Beijing 100700, China.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Yang', 'Affiliation': 'Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Xue', 'Affiliation': 'Department of Endocrinology, Nanfang Hospital of Nanfang Medical University, Guangzhou 510515, China.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Zhu', 'Affiliation': 'Department of Endocrinology, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'Y Q', 'Initials': 'YQ', 'LastName': 'Shi', 'Affiliation': 'Department of Endocrinology, Shanghai Changzheng Hospital, Shanghai 200003, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Endocrinology, Shanghai Changhai Hospital, Shanghai 200433, China.'}, {'ForeName': 'Z G', 'Initials': 'ZG', 'LastName': 'Zhou', 'Affiliation': 'Department of Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Q H', 'Initials': 'QH', 'LastName': 'Ji', 'Affiliation': ""Department of Endocrinology, Xijing Hospital, Fourth Military Medical University, Xi'an 710032, China.""}, {'ForeName': 'Y B', 'Initials': 'YB', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Zhongshan Hospital of Fudan University, Shanghai 200032, China.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lu', 'Affiliation': 'Department of Endocrinology, The First Medical Center, Chinese PLA General Hospital, Beijing 100853, China.'}, {'ForeName': 'J Q', 'Initials': 'JQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.'}, {'ForeName': 'X H', 'Initials': 'XH', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, Beijing 100034, China.'}]",Zhonghua nei ke za zhi,['10.3760/cma.j.cn112138-20200423-00417']
2960,33256220,Effects of Matcha Green Tea Powder on Cognitive Functions of Community-Dwelling Elderly Individuals.,"Matcha Green Tea Powder contains a variety of active ingredients beneficial to health, such as tea catechins, lutein and vitamin K. It is also known that these ingredients confer benefits upon cognitive functions of elderly people. Therefore, we aimed to investigate the relationship between a daily supplementation of Matcha and the change in cognitive functions of community-dwelling elderly people. A randomized, double-blind, placebo-controlled 12-week trial was performed. Sixty-one participants were recruited and randomly assigned to receive test drink containing 3g powder from fresh Matcha or placebo powder per day. Changes in cognitive function were assessed utilizing a psychometric test battery. Daily food intake was assessed by a Brief-type Self-administered Diet History Questionnaire (BDHQ). In the gender-specific analysis, a significant cognitive enhancement was observed in the Montreal Cognitive Assessment (MoCA) score in the active group of women. In dietary analysis, we found a significant inverse correlation between consumption of vitamin K in daily diet, excluding test drinks, and change in MoCA. The present study suggests that daily supplementation of Matcha Green Tea Powder has protective effects against cognitive decline in community-dwelling elderly women.",2020,"In the gender-specific analysis, a significant cognitive enhancement was observed in the Montreal Cognitive Assessment (MoCA) score in the active group of women.","['community-dwelling elderly women', 'Sixty-one participants', 'elderly people', 'Community-Dwelling Elderly Individuals', 'community-dwelling elderly people']","['placebo', 'test drink containing 3g powder from fresh Matcha or placebo powder per day', 'Matcha Green Tea Powder']","['cognitive functions', 'Montreal Cognitive Assessment (MoCA) score', 'Cognitive Functions', 'Daily food intake', 'Brief-type Self-administered Diet History Questionnaire (BDHQ', 'cognitive function']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",61.0,0.273988,"In the gender-specific analysis, a significant cognitive enhancement was observed in the Montreal Cognitive Assessment (MoCA) score in the active group of women.","[{'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Sakurai', 'Affiliation': 'Department of Integrated Biosciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa 277-8562, Japan.'}, {'ForeName': 'Chutong', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': 'Department of Integrated Biosciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa 277-8562, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Ezaki', 'Affiliation': 'Department of Integrated Biosciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa 277-8562, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Inamura', 'Affiliation': 'Community Health Promotion Laboratory, Mitsui Fudosan, Co., Ltd., Kashiwa 277-8519, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Fukushima', 'Affiliation': 'Marketing & Communications Division, Nestle Japan Ltd., Tokyo 140-0002, Japan.'}, {'ForeName': 'Nobutaka', 'Initials': 'N', 'LastName': 'Masuoka', 'Affiliation': 'Department of Integrated Biosciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa 277-8562, Japan.'}, {'ForeName': 'Tatsuhiro', 'Initials': 'T', 'LastName': 'Hisatsune', 'Affiliation': 'Department of Integrated Biosciences, Graduate School of Frontier Sciences, The University of Tokyo, Kashiwa 277-8562, Japan.'}]",Nutrients,['10.3390/nu12123639']
2961,33256192,Using Laser-Doppler Flowmetry to Evaluate the Therapeutic Response in Dentin Hypersensitivity.,"Dentin hypersensitivity (DH) is a common medical condition with underreported prevalence and it is difficult to quantify. This study aimed to investigate whether assessing dental pulp vascular micro-dynamics by laser-Doppler flowmetry (LDF) would be functional for therapeutic evaluation, in contrast to a verbal rating scale (VRS). A split-mouth single-blind randomized study was conducted on seven patients and a total of 36 teeth. Two DH therapeutic methods were employed: (i) fluoride gel; (ii) Nd:YAG radiation combined with fluoride gel. For each tooth, five consecutive LDF determinations of pulp blood flow were made (before and immediately after desensitizing treatment, then after 24 h, 7 days, and 1 month), and the VRS was applied each time. Spearman's correlation was applied for concurrent validation. Two-way (treatment and patient) repeated measures ANOVA full factorial was applied, followed by Tukey's post-hoc comparisons and Pillai's trace multivariate statistic. While VRS scores had moderate reliability, LDF could objectively estimate treatment effects. Based on partial eta-squared values, treatment and patient characteristics were estimated to explain about 84% and 50% of the variability, respectively. In conclusion, LDF is an objective technique that can quantitatively assess DH evolution, and it is effective in reliably monitoring oral health therapeutic interventions.",2020,"While VRS scores had moderate reliability, LDF could objectively estimate treatment effects.","['seven patients and a total of 36 teeth', 'Dentin Hypersensitivity']","['Laser-Doppler Flowmetry', 'fluoride gel', 'fluoride gel; (ii', 'dental pulp vascular micro-dynamics by laser-Doppler flowmetry (LDF', 'LDF']","['Dentin hypersensitivity (DH', 'verbal rating scale (VRS']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}]","[{'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}, {'cui': 'C3881208', 'cui_str': 'Fluoride gel'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]","[{'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0458261', 'cui_str': 'Verbal rating scale'}]",7.0,0.0221657,"While VRS scores had moderate reliability, LDF could objectively estimate treatment effects.","[{'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Miron', 'Affiliation': 'Department of Oral Rehabilitation and Dental Emergencies, Faculty of Dentistry, ""Victor Babes"" University of Medicine and Pharmacy, P-ta Eftimie Murgu 2, 300041 Timisoara, Romania.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Lungeanu', 'Affiliation': 'Center for Modeling Biological Systems and Data Analysis, Department of Functional Sciences, ""Victor Babes"" University of Medicine and Pharmacy, P-ta Eftimie Murgu 2, 300041 Timisoara, Romania.'}, {'ForeName': 'Edmond', 'Initials': 'E', 'LastName': 'Ciora', 'Affiliation': 'Department of Oral Rehabilitation and Dental Emergencies, Faculty of Dentistry, ""Victor Babes"" University of Medicine and Pharmacy, P-ta Eftimie Murgu 2, 300041 Timisoara, Romania.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Ogodescu', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, ""Victor Babes"" University of Medicine and Pharmacy, P-ta Eftimie Murgu 2, 300041 Timisoara, Romania.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Todea', 'Affiliation': 'Department of Oral Rehabilitation and Dental Emergencies, Faculty of Dentistry, ""Victor Babes"" University of Medicine and Pharmacy, P-ta Eftimie Murgu 2, 300041 Timisoara, Romania.'}]",International journal of environmental research and public health,['10.3390/ijerph17238787']
2962,33256141,Is Machine Learning a Better Way to Identify COVID-19 Patients Who Might Benefit from Hydroxychloroquine Treatment?-The IDENTIFY Trial.,"Therapeutic agents for the novel coronavirus disease 2019 (COVID-19) have been proposed, but evidence supporting their use is limited. A machine learning algorithm was developed in order to identify a subpopulation of COVID-19 patients for whom hydroxychloroquine was associated with improved survival; this population might be relevant for study in a clinical trial. A pragmatic trial was conducted at six United States hospitals. We enrolled COVID-19 patients that were admitted between 10 March and 4 June 2020. Treatment was not randomized. The study endpoint was mortality; discharge was a competing event. Hazard ratios were obtained on the entire population, and on the subpopulation indicated by the algorithm as suitable for treatment. A total of 290 patients were enrolled. In the subpopulation that was identified by the algorithm, hydroxychloroquine was associated with a statistically significant ( p = 0.011) increase in survival (adjusted hazard ratio 0.29, 95% confidence interval (CI) 0.11-0.75). Adjusted survival among the algorithm indicated patients was 82.6% in the treated arm and 51.2% in the arm not treated. No association between treatment and mortality was observed in the general population. A 31% increase in survival at the end of the study was observed in a population of COVID-19 patients that were identified by a machine learning algorithm as having a better outcome with hydroxychloroquine treatment. Precision medicine approaches may be useful in identifying a subpopulation of COVID-19 patients more likely to be proven to benefit from hydroxychloroquine treatment in a clinical trial.",2020,A 31% increase in survival at the end of the study was observed in a population of COVID-19 patients that were identified by a machine learning algorithm as having a better outcome with hydroxychloroquine treatment.,"['six United States hospitals', '290 patients were enrolled', 'enrolled COVID-19 patients that were admitted between 10 March and 4 June 2020', 'COVID-19 Patients']","['hydroxychloroquine', 'Hydroxychloroquine']","['survival', 'mortality', 'Adjusted survival', 'Hazard ratios', 'mortality; discharge']","[{'cui': 'C0020026', 'cui_str': 'State Hospitals'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",290.0,0.0785269,A 31% increase in survival at the end of the study was observed in a population of COVID-19 patients that were identified by a machine learning algorithm as having a better outcome with hydroxychloroquine treatment.,"[{'ForeName': 'Hoyt', 'Initials': 'H', 'LastName': 'Burdick', 'Affiliation': 'Cabell Huntington Hospital, Huntington, WV 25701, USA.'}, {'ForeName': 'Carson', 'Initials': 'C', 'LastName': 'Lam', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Samson', 'Initials': 'S', 'LastName': 'Mataraso', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Siefkas', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Braden', 'Affiliation': 'Kidney Care and Transplant Associates of New England, Springfield, MA 01104, USA.'}, {'ForeName': 'R Phillip', 'Initials': 'RP', 'LastName': 'Dellinger', 'Affiliation': 'Division of Critical Care Medicine, Cooper University Hospital/Cooper Medical School of Rowan University, Camden, NJ 08103, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McCoy', 'Affiliation': 'Cape Regional Medical Center, Cape May Court House, NJ 08210, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme University Hospital, Université Libre de Bruxelles, 1050 Brussels, Belgium.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Green-Saxena', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Barnes', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Hoffman', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Calvert', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pellegrini', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}, {'ForeName': 'Ritankar', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Dascena, Inc., San Francisco, CA 94115, USA.'}]",Journal of clinical medicine,['10.3390/jcm9123834']
2963,33256031,"Characterization of Preoperative, Postsurgical, Acute and Chronic Pain in High Risk Breast Cancer Patients.","BACKGROUND
Pain after breast cancer surgery remains largely unexplained and inconsistently quantified. This study aims to describe the perioperative pain patterns in patients with breast cancer, up to two years after surgery.
METHODS
This is a pre-planned sub-study of the Ketorolac in Breast Cancer (KBC) trial. The KBC trial was a multicentre, prospective, double-blind, placebo-controlled, randomised trial of a single dose of 30 mg of ketorolac just before breast cancer surgery, aiming to test its effect on recurrences. This sub-study focuses only on pain outcomes. From 2013 to 2015, 203 patients were randomised to ketorolac ( n = 96) or placebo ( n = 107). Structured questionnaires were delivered by telephone after one and two years, exploring the presence, location, permanence, and frequency of pain. Patients' perceptions of pain were captured by an open-ended question, the responses to which were coded and classified using hierarchical clustering.
RESULTS
There was no difference in pain between the ketorolac and the placebo group. The reported incidence of permanent pain was 67% and 45% at one and two years, respectively. The largest category was musculoskeletal pain. Permanent pain was mainly described in patients with musculoskeletal pain. The description of pain changed in most patients during the second postoperative year, i.e., moved from one category to another (no pain, permanent, or non-permanent pain, but also, the localisation). This phenomenon includes patients without pain at one year.
CONCLUSIONS
Pain is a complex phenomenon, but also a fragile and unstable endpoint. Pain after breast cancer surgery does not necessarily mean breast pain but also musculoskeletal and other pains. The permanence of pain and the pain phenotype can change over time.",2020,There was no difference in pain between the ketorolac and the placebo group.,"['High Risk Breast Cancer Patients', 'patients with musculoskeletal pain', 'patients without pain at one year', 'patients with breast cancer, up to two years after surgery', 'From 2013 to 2015, 203 patients']","['ketorolac', 'placebo', 'Ketorolac']","['permanent pain', 'Pain', 'permanence of pain and the pain phenotype', 'Permanent pain', 'pain', 'perioperative pain patterns']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0547050', 'cui_str': 'Permanences'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C1286321', 'cui_str': 'Pattern of pain'}]",203.0,0.260452,There was no difference in pain between the ketorolac and the placebo group.,"[{'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Forget', 'Affiliation': 'Institute of Applied Health Sciences, Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Taalke M', 'Initials': 'TM', 'LastName': 'Sitter', 'Affiliation': 'Institute of Applied Health Sciences, Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Rosemary J', 'Initials': 'RJ', 'LastName': 'Hollick', 'Affiliation': 'Institute of Applied Health Sciences, Epidemiology Group, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Dixon', 'Affiliation': 'Institute of Applied Health Sciences, Health Psychology, School of Medicine, Medical Sciences and Nutrition, University of Aberdeen, Aberdeen AB25 2ZD, UK.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'van Maanen', 'Affiliation': 'Biostatistics Unit, King Albert II Institute, Cliniques universitaires Saint-Luc, 1200 Brussels, Belgium.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Dekleermaker', 'Affiliation': 'Clinical Pharmacology Unit, Cliniques universitaires Saint-Luc, 1200 Brussels, Belgium.'}, {'ForeName': 'Francois P', 'Initials': 'FP', 'LastName': 'Duhoux', 'Affiliation': ""Institut Roi Albert II, Service d'Oncologie Médicale, Cliniques universitaires Saint-Luc and Institut de Recherche Expérimentale et Clinique (POLE MIRO), UCLouvain, 1200 Brussels, Belgium.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Kock', 'Affiliation': 'Department of Anesthesiology, Centre Hospitalier Wallonie Picarde (CHWAPI), 7500 Tournai, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Berliere', 'Affiliation': 'Department of Gynecology, Breast Clinic, King Albert II Institute, Cliniques universitaires Saint-Luc, UCLouvain, 1200 Brussels, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': 'On Behalf Of The KBCt Group', 'Affiliation': ''}]",Journal of clinical medicine,['10.3390/jcm9123831']
2964,33256020,A Validation and Cost-Analysis Study of a Targeted School-Based Dental Check-Up Intervention: Children's Dental Program.,"BACKGROUND
Limited evidence exists to inform best practice approaches to implement school-based dental screening to address child retention via referral for dental services. This research tested the null hypothesis that a targeted school-based dental check-up program (intervention) has a 75% child retention rate for public dental care (H 0 = 0.75).
METHODS
A prospective non-randomised controlled trial was conducted with a convenience sampling approach in metropolitan Melbourne, Australia. Children in the intervention group were recruited from two preschools and two primary schools from a low socioeconomic area. Children in the standard care group were recruited from the local public dental service. Statistical analysis was performed using Stata IC Version 12.
RESULTS
Children in the intervention (45%) were significantly less likely to have never had a dental check-up compared to standard care (20%) ( p < 0.001). There was no significant difference for the child retention rate for the intervention group when compared against the null hypothesis ( p = 0.954). The total society costs were AU$754.7 and AU$612.2 for the intervention and standard care groups, respectively ( p = 0.049).
CONCLUSIONS
This validation study provides evidence that a targeted school-based dental check-up program can achieve a 75% child retention rate and should be considered for program expansion.",2020,"The total society costs were AU$754.7 and AU$612.2 for the intervention and standard care groups, respectively ( p = 0.049).
","['Children in the intervention group were recruited from two preschools and two primary schools from a low socioeconomic area', ""Children's Dental Program"", 'Children in the standard care group were recruited from the local public dental service', 'convenience sampling approach in metropolitan Melbourne, Australia']",['Targeted School-Based Dental Check-Up Intervention'],"['total society costs', 'child retention rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750862', 'cui_str': 'Dental examination'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.0495276,"The total society costs were AU$754.7 and AU$612.2 for the intervention and standard care groups, respectively ( p = 0.049).
","[{'ForeName': 'Tan Minh', 'Initials': 'TM', 'LastName': 'Nguyen', 'Affiliation': 'Deakin Health Economics, Institute of Health Transformation, Faculty of Health, Deakin University, Waurn Ponds, VIC 3216, Australia.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Christian', 'Affiliation': 'Dentistry and Oral Health, La Trobe Rural Health School, La Trobe University, Bundoora, VIC 3552, Australia.'}, {'ForeName': 'Sajeev', 'Initials': 'S', 'LastName': 'Koshy', 'Affiliation': 'Dental Health Services Victoria, Carlton, VIC 3053, Australia.'}, {'ForeName': 'Michael Vivian', 'Initials': 'MV', 'LastName': 'Morgan', 'Affiliation': 'Faculty of Dentistry, University of Otago, Dunedin 9016, New Zealand.'}]","Children (Basel, Switzerland)",['10.3390/children7120257']
2965,33255975,Efficacy of an Objective Structured Clinical Examination Training Approach for Training Pharmacy Students in Diabetes Mellitus Counseling: A Randomized Controlled Trial.,"Pharmacists' tasks are multifaceted and include, for example, vital counseling and communication skills. Objective Structured Clinical Examinations (OSCEs) could be used to train pharmacy students in these skills. Our study sought to determine the efficacy of our OSCE training approach for training pharmacy students' counseling and communication skills on diabetes mellitus compared to a control group. This randomized controlled study was conducted with pharmacy students using a pre-post-design. The intervention group completed diabetes OSCE training, while the control group solved diabetes patient cases using subjective, objective, assessment, and plan notes. Before and after the respective training, both groups completed OSCEs evaluating counseling and communication skills. Before each OSCE encounter, the participants completed a self-assessment questionnaire and, upon completion of the seminar, filled out a satisfaction survey. The OSCE-trained group demonstrated a significantly greater increase in counseling and communication skills and self-confidence than the control group. Both groups were generally satisfied with the seminar. These results demonstrate that our OSCE training approach allows for the effective training of pharmacy students' diabetes counseling and communication skills and suggests the inclusion of such a skill-based approach more widely in pharmacy students' education.",2020,The OSCE-trained group demonstrated a significantly greater increase in counseling and communication skills and self-confidence than the control group.,"['pharmacy students using a pre-post-design', 'Training Pharmacy Students in Diabetes Mellitus Counseling']","['Objective Structured Clinical Examination Training Approach', 'OSCE training approach', 'diabetes OSCE training']","['diabetes mellitus', 'counseling and communication skills and self-confidence']","[{'cui': 'C0038497', 'cui_str': 'Pharmacy Student'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0241013,The OSCE-trained group demonstrated a significantly greater increase in counseling and communication skills and self-confidence than the control group.,"[{'ForeName': 'Imaneh', 'Initials': 'I', 'LastName': 'Farahani', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Samieh', 'Initials': 'S', 'LastName': 'Farahani', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Maira A', 'Initials': 'MA', 'LastName': 'Deters', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Schwender', 'Affiliation': 'Mathematical Institute, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Laeer', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8040229']
2966,33255807,Ultra-Marathon-Induced Increase in Serum Levels of Vitamin D Metabolites: A Double-Blind Randomized Controlled Trial.,"PURPOSE
While an increasing number of studies demonstrate the importance of vitamin D for athletic performance, the effects of any type of exercise on vitamin D metabolism are poorly characterized. We aimed to identify the responses of some vitamin D metabolites to ultra-marathon runs.
METHODS
A repeated-measures design was implemented, in which 27 amateur runners were assigned into two groups: those who received a single dose of vitamin D 3 (150,000 IU) 24 h before the start of the marathon ( n = 13) and those ( n = 14) who received a placebo. Blood samples were collected 24 h before, immediately after, and 24 h after the run.
RESULTS
In both groups of runners, serum 25(OH)D 3 , 24,25(OH) 2 D 3 , and 3- epi -25(OH)D 3 levels significantly increased by 83%, 63%, and 182% after the ultra-marathon, respectively. The increase was most pronounced in the vitamin D group. Body mass and fat mass significantly decreased after the run in both groups.
CONCLUSIONS
Ultra-marathon induces the mobilization of vitamin D into the blood. Furthermore, the 24,25(OH) 2 D 3 and 3- epi -25(OH)D 3 increases imply that the exercise stimulates vitamin D metabolism.",2020,"Body mass and fat mass significantly decreased after the run in both groups.
",['27 amateur runners'],"['vitamin D 3 (150,000 IU', 'placebo', 'vitamin D']","['exercise stimulates vitamin D metabolism', '3- epi -25(OH)D 3 levels', 'Serum Levels of Vitamin D Metabolites', 'Body mass and fat mass', 'Blood samples']",[],"[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.229706,"Body mass and fat mass significantly decreased after the run in both groups.
","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mieszkowski', 'Affiliation': 'Department of Gymnastics and Dance, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Błażej', 'Initials': 'B', 'LastName': 'Stankiewicz', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Kochanowicz', 'Affiliation': 'Department of Gymnastics and Dance, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Bartłomiej', 'Initials': 'B', 'LastName': 'Niespodziński', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Kowalik', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Żmijewski', 'Affiliation': 'Department of Histology, Medical University of Gdańsk, 80-211 Gdansk, Poland.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Kowalski', 'Affiliation': 'Masdiag Sp. z o.o. Company, 01-882 Warsaw, Poland.'}, {'ForeName': 'Rafał', 'Initials': 'R', 'LastName': 'Rola', 'Affiliation': 'Masdiag Sp. z o.o. Company, 01-882 Warsaw, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Bieńkowski', 'Affiliation': 'Masdiag Sp. z o.o. Company, 01-882 Warsaw, Poland.'}, {'ForeName': 'Jędrzej', 'Initials': 'J', 'LastName': 'Antosiewicz', 'Affiliation': 'Department of Bioenergetics and Physiology of Exercise, Medical University of Gdansk, 80-210 Gdansk, Poland.'}]",Nutrients,['10.3390/nu12123629']
2967,33255787,Pharmacokinetics of Sodium and Calcium Salts of (6S)-5-Methyltetrahydrofolic Acid Compared to Folic Acid and Indirect Comparison of the Two Salts.,"(6S)-5-Methyltetrahydrofolic acid ((6S)-5-Methyl-THF) salts and folic acid may differ in their abilities to raise plasma (6S)-5-Methyl-THF levels. We compared the area under the curve (AUC), C max , and T max of plasma (6S)-5-Methyl-THF after intakes of (6S)-5-Methyl-THF-Na salt (Arcofolin ® ) and folic acid. Moreover, we compared the AUCs after intakes of (6S)-5-Methyl-THF-Na and the calcium salt, (6S)-5-Methyl-THF-Ca, that were tested against folic acid in two independent studies. The study was randomized, double blind, and cross over. Twenty-four adults (12 men and 12 women) received a single oral dose of 436 µg (6S)-5-Methyl-THF-Na and an equimolar dose of folic acid (400 µg) on two kinetic days with two weeks washout period in between. The plasma concentrations of (6S)-5-Methyl-THF were measured at 9 time points between 0 and 8 h. We found that the AUC 0-8 h of plasma (6S)-5-Methyl-THF (mean (SD) = 126.0 (33.6) vs. 56.0 (25.3) nmol/L*h) and C max (36.8 (10.8) vs. 11.1 (4.1) nmol/L) were higher after administration of (6S)-5-Methyl-THF-Na than after the administration of folic acid ( p < 0.001 for both). These differences were present in men and women. Only administration of folic acid resulted in a transient increase in plasma unmetabolized folic acid (2.5 (2.0) nmol/L after 0.5 h and 4.7 (2.9) nmol/L after 1 h). Intake of (6S)-5-Methyl-THF-Na was safe. The ratios of the AUC 0-8 h for (6S)-5-Methyl-THF-Na and (6S)-5-Methyl-THF-Ca to the corresponding folic acid reference group and the delta of these AUC 0-8 h did not differ between the studies. In conclusion, a single oral dose of (6S)-5-Methyl-THF-Na caused higher AUC 0-8 h and C max of plasma (6S)-5-Methyl-THF compared to folic acid. The Na- and Ca- salts of (6S)-5-Methyl-THF are not likely to differ in their pharmacokinetics. Further studies may investigate whether supplementation of the compounds for a longer time will lead to differences in circulating or intracellular/tissue folate concentrations.",2020,Only administration of folic acid resulted in a transient increase in plasma unmetabolized folic acid (2.5 (2.0) nmol/L after 0.5 h and 4.7 (2.9) nmol/L after 1 h).,"['men and women', 'Twenty-four adults (12 men and 12 women']","['folic acid', 'Folic Acid', '6S)-5-Methyltetrahydrofolic acid ((6S)-5-Methyl-THF) salts and folic acid', 'Sodium and Calcium Salts of (6S)-5-Methyltetrahydrofolic Acid', 'single oral dose of 436 µg (6S)-5-Methyl-THF-Na and an equimolar dose of folic acid']","['plasma unmetabolized folic acid', 'Na- and Ca- salts', 'plasma concentrations of (6S)-5-Methyl-THF', 'AUC 0-8 h of plasma (6S)-5-Methyl-THF', 'area under the curve (AUC), C max , and T max of plasma (6S)-5-Methyl-THF after intakes of (6S)-5-Methyl-THF-Na salt (Arcofolin ® ) and folic acid']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C2825462', 'cui_str': 'Levomefolic acid'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",,0.0488439,Only administration of folic acid resulted in a transient increase in plasma unmetabolized folic acid (2.5 (2.0) nmol/L after 0.5 h and 4.7 (2.9) nmol/L after 1 h).,"[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Obeid', 'Affiliation': 'Laboratory Medicine, Department of Clinical Chemistry, Saarland University Hospital, Building 57, D-66424 Homburg/Saar, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Schön', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, D-73728 Esslingen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pietrzik', 'Affiliation': 'Department of Nutrition and Food Science, Rheinische Friedrich-Wilhelms University, Endenicher Allee 19B, D-53115 Bonn, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Menzel', 'Affiliation': 'BioTeSys GmbH, Schelztorstr. 54-56, D-73728 Esslingen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Mathematics, Natural and Economic Sciences, Ulm University of Applied Sciences, Albert-Einstein-Allee 55, D-89081 Ulm, Germany.'}, {'ForeName': 'Yvo', 'Initials': 'Y', 'LastName': 'Smulders', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Location VUmc, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Knapp', 'Affiliation': 'Merck & Cie, Im Laternenacker 5, CH-8200 Schaffhausen, Switzerland.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Böhni', 'Affiliation': 'Merck & Cie, Im Laternenacker 5, CH-8200 Schaffhausen, Switzerland.'}]",Nutrients,['10.3390/nu12123623']
2968,33255731,"Lactobacillus helveticus SBT2171 Alleviates Perennial Allergic Rhinitis in Japanese Adults by Suppressing Eosinophils: A Randomized, Double-Blind, Placebo-Controlled Study.","This article examines the effects of fermented milk (FM) containing Lactobacillus helveticus SBT2171 (LH2171) on the subjective symptoms of individuals with mild and moderate perennial allergy. Two hundred subjects were divided into two groups and consumed FM containing LH2171 or placebo FM once per day for 16 weeks. The primary endpoints were defined as per the degree of nasal and ocular symptoms and difficulty in daily life as determined by the Japanese guidelines for allergy rhinitis and the Japanese allergic rhinitis standard quality of life questionnaire, respectively. The secondary endpoints included parameters related to allergic symptoms in the blood and nasal fluids, as well as the mental status. The severity of allergic rhinitis significantly improved in the LH2171 group compared to that in the placebo group. Additionally, the LH2171 group showed a significantly lower degree of ""stuffy nose"" (as per the diary survey) than the placebo group. Eosinophil counts in the nasal fluids and in the blood were significantly lower in the LH2171 group compared to the placebo group. Thus, the oral administration of FM containing LH2171 cells alleviated perennial allergic rhinitis in individuals with mild and moderate symptoms, possibly via suppression of eosinophils in both the blood and nasal fluids.",2020,Eosinophil counts in the nasal fluids and in the blood were significantly lower in the LH2171 group compared to the placebo group.,"['Two hundred subjects', 'individuals with mild and moderate symptoms', 'Japanese Adults by Suppressing Eosinophils', 'individuals with mild and moderate perennial allergy']","['fermented milk (FM) containing Lactobacillus helveticus SBT2171 ', 'FM containing LH2171 or placebo FM', 'placebo', 'LH2171', 'SBT2171', 'Placebo', 'FM containing LH2171 cells']","['Eosinophil counts', 'perennial allergic rhinitis', 'severity of allergic rhinitis', 'allergic symptoms in the blood and nasal fluids, as well as the mental status', 'degree of ""stuffy nose', 'degree of nasal and ocular symptoms and difficulty in daily life as determined by the Japanese guidelines for allergy rhinitis and the Japanese allergic rhinitis standard quality of life questionnaire']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C2721639', 'cui_str': 'Perennial allergy'}]","[{'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0035457', 'cui_str': 'Perennial allergic rhinitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1444694', 'cui_str': 'Nasal fluid'}, {'cui': 'C0278060', 'cui_str': 'Mental state'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0008711', 'cui_str': 'Chronic rhinitis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",200.0,0.109691,Eosinophil counts in the nasal fluids and in the blood were significantly lower in the LH2171 group compared to the placebo group.,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Miyoshi', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Iwai', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Takeda', 'Affiliation': 'Department of Nutritional Sciences for Well-Being, Faculty of Health Sciences for Welfare, Kansai University of Welfare Sciences, 3-11-1, Ashigaoka, Kashiwara, Osaka 582-0026, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ono', 'Affiliation': 'Ueno-Asagao Clinic, 6F Kairaku Building, 2-7-5, Higashiueno, Taito, Tokyo 110-0015, Japan.'}, {'ForeName': 'Toshihide', 'Initials': 'T', 'LastName': 'Kabuki', 'Affiliation': 'Milk Science Research Institute, MEGMILK SNOW BRAND Co. Ltd., 1-1-2, Minamidai, Kawagoe, Saitama 350-1165, Japan.'}]",Nutrients,['10.3390/nu12123620']
2969,33255726,Effectiveness of an Advanced Clinical Decision Support System on Clinical Decision-Making Skills in a Call Center Medication Therapy Management Pharmacy Setting: A Pilot Study.,"(1) Background: There is limited evidence related to the efficacy of advanced clinical decision support systems (CDSS) on the quantity of high-quality clinical recommendations in a pharmacy-related medication therapy management (MTM) setting. The study aimed to assess the effect of an advanced CDSS on the quantity of relevant clinical pharmacist recommendations in a call center MTM setting. (2) Methods: This pre-test/post-test with comparator group study compared clinical skills assessment scores between certified MTM pharmacists in March 2020. A Wilcoxon Signed Rank test assessed the difference between pre- and post-test scores in both groups. (3) Results: Of 20 participants, the majority were less than 40 years old (85%) with a Doctor of Pharmacy degree (90%). Nine were female. Intervention group participants had less than three years of experience as a pharmacist. The control group had less than three years (40%) or seven to ten years (40%) of experience. There was a significant increase in intervention group scores between pre- (median = 3.0, IQR = 3.0) and post-test segments (median = 6.5, IQR = 4.0, p = 0.02). There was no significant change between control group pre- and post-test segments ( p = 0.48). (4) Conclusion: Pharmacist exposure to an advanced CDSS was associated with significantly increased quantity of relevant clinical recommendations in an MTM pharmacy setting.",2020,"There was a significant increase in intervention group scores between pre- (median = 3.0, IQR = 3.0) and post-test segments (median = 6.5, IQR = 4.0, p = 0.02).","['Of 20 participants, the majority were less than 40 years old (85%) with a Doctor of Pharmacy degree (90', 'certified MTM pharmacists in March 2020']","['Advanced Clinical Decision Support System', 'advanced CDSS']",[],"[{'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C1611232', 'cui_str': 'Drug Therapy Management'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0525070', 'cui_str': 'Clinical Decision Support Systems'}]",[],,0.0512879,"There was a significant increase in intervention group scores between pre- (median = 3.0, IQR = 3.0) and post-test segments (median = 6.5, IQR = 4.0, p = 0.02).","[{'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Bingham', 'Affiliation': 'Applied Precision Pharmacotherapy Institute, Tabula Rasa HealthCare, Tucson, AZ 85701, USA.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': 'Michaud', 'Affiliation': 'Precision Pharmacotherapy Research & Development Institute, Tabula Rasa HealthCare, Lake Nona, FL 32827, USA.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Turgeon', 'Affiliation': 'Precision Pharmacotherapy Research & Development Institute, Tabula Rasa HealthCare, Lake Nona, FL 32827, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Axon', 'Affiliation': 'Department of Pharmaceutical Sciences, College of Pharmacy, University of Arizona, Tucson, AZ 85721, USA.'}]","Pharmacy (Basel, Switzerland)",['10.3390/pharmacy8040228']
2970,33255704,Effectiveness of Psychological Capital Intervention and Its Influence on Work-Related Attitudes: Daily Online Self-Learning Method and Randomized Controlled Trial Design.,"Research on positive psychology intervention is in its infancy; only a few empirical studies have proved the effectiveness and benefits of psychological capital interventions in workplaces. From a practical perspective, a more convenient intervention approach is needed for when organizations have difficulties in finding qualified trainers. This study aims to extend the psychological capital intervention (PCI) model and examine its influence on work-related attitudes. A daily online self-learning approach and a randomized controlled trial design are utilized. A final sample of 104 full-time employees, recruited online, is randomly divided into three groups to fill in self-report questionnaires immediately before (T1), immediately after (T2), and one week after (T3) the intervention. The results indicate that the intervention is effective at improving psychological capital (PsyCap), increasing job satisfaction, and reducing turnover intention. The practical implications for human resource managers conducting a flexible and low-cost PsyCap intervention in organizations are discussed. Limitations related to sample characteristics, short duration effect, small sample size, and small effect size are also emphasized. Due to these non-negligible drawbacks of the study design, this study should only be considered as a pilot study of daily online self-learning PsyCap intervention research.",2020,"The results indicate that the intervention is effective at improving psychological capital (PsyCap), increasing job satisfaction, and reducing turnover intention.","['A final sample of 104 full-time employees', 'Work-Related Attitudes']","['Psychological Capital Intervention', 'psychological capital intervention (PCI']","['effective at improving psychological capital (PsyCap), increasing job satisfaction, and reducing turnover intention']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0031227', 'cui_str': 'Employee Turnover'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",104.0,0.0285883,"The results indicate that the intervention is effective at improving psychological capital (PsyCap), increasing job satisfaction, and reducing turnover intention.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Da', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, National Demonstration Center for Experimental Psychology Education (Beijing Normal University), Faculty of Psychology, Beijing Normal University, Beijing 100875, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, National Demonstration Center for Experimental Psychology Education (Beijing Normal University), Faculty of Psychology, Beijing Normal University, Beijing 100875, China.'}, {'ForeName': 'Xichao', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Beijing Key Laboratory of Applied Experimental Psychology, National Demonstration Center for Experimental Psychology Education (Beijing Normal University), Faculty of Psychology, Beijing Normal University, Beijing 100875, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17238754']
2971,33255675,Development and Pretesting of Hookah Tobacco Public Education Messages for Young Adults.,"Young adults' hookah tobacco use is fueled by misperceptions about risks, appealing flavors, and social use. We developed and pretested public education messages to prevent and reduce hookah tobacco smoking among young adults. We used a two (user status: current hookah user, susceptible never user) by two (risk content: health harms or addiction) by three (message theme: harms/addiction risk alone, harms/addiction risk flavors, or harms/addiction risk social use) design with two messages/condition ( n = 12 total messages). Young adults aged 18-30 ( N = 713) were randomized to 1 of 12 messages and completed measures assessing message receptivity, attitudes, and negative emotional response. Harms messages were associated with greater receptivity ( p < 0.001), positive attitudes ( p < 0.001), and negative emotional response ( p < 0.001) than addiction messages. Messages with harm or addiction content alone were associated with greater receptivity than social use-themed messages ( p = 0.058). Flavor-themed messages did not differ in receptivity from harm or addiction content alone or social use-themed messages. Messages about the health harms of hookah tobacco use resonate more with young adults than addiction risk messages. Social use-themed messages produce the lowest receptivity. These findings can guide population-based approaches to communicate hookah tobacco risks to young adults.",2020,"Harms messages were associated with greater receptivity ( p < 0.001), positive attitudes ( p < 0.001), and negative emotional response ( p < 0.001) than addiction messages.","['Young Adults', 'young adults', 'Young adults aged 18-30 ( N = 713']",[],"['positive attitudes', 'greater receptivity', 'negative emotional response', 'hookah tobacco smoking', 'message receptivity, attitudes, and negative emotional response']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C4505132', 'cui_str': 'Hookah Tobacco'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",713.0,0.0361716,"Harms messages were associated with greater receptivity ( p < 0.001), positive attitudes ( p < 0.001), and negative emotional response ( p < 0.001) than addiction messages.","[{'ForeName': 'Lilianna', 'Initials': 'L', 'LastName': 'Phan', 'Affiliation': 'Cancer Prevention & Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, 3300 Whitehaven Street NW, Suite 4100, Washington, DC 20007, USA.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Vermont Center on Behavior and Health, Department of Psychiatry, University of Vermont, 1 South Prospect Street MS 482, Burlington, VT 05401, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Leshner', 'Affiliation': 'Gaylord College of Journalism and Mass Communication, University of Oklahoma, 3520B Gaylord Hall, Norman, OK 73019, USA.'}, {'ForeName': 'Theodore L', 'Initials': 'TL', 'LastName': 'Wagener', 'Affiliation': 'Center for Tobacco Research, The Ohio State University James Comprehensive Cancer Center, Department of Internal Medicine, The Ohio State University, 3650 Olentangy River Road, Suite 410, Columbus, OH 43214, USA.'}, {'ForeName': 'Elise M', 'Initials': 'EM', 'LastName': 'Stevens', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Harvard University, 677 Huntington Ave, Boston, MA 02115, USA.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Department of Psychiatry and Tobacco Center of Regulatory Science, Perlman School of Medicine, University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Center for Tobacco Research, The Ohio State University James Comprehensive Cancer Center, Department of Internal Medicine, The Ohio State University, 3650 Olentangy River Road, Suite 410, Columbus, OH 43214, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17238752']
2972,33255579,Effects of Labelling and Increasing the Proportion of Lower-Energy Density Products on Online Food Shopping: A Randomised Control Trial in High- and Low-Socioeconomic Position Participants.,"Reducing the energy density (ED) of product selections made during online supermarket food shopping has potential to decrease energy intake. Yet it is unclear which types of intervention are likely to be most effective and equitable. We recruited 899 UK adults of lower and higher socioeconomic position (SEP) who completed a shopping task in an online experimental supermarket. Participants were randomised in a 2 × 2 between-subjects design to test the effects of two interventions on the ED of shopping basket selections: labelling lower-ED products as healthier choices and increasing the relative availability of lower-ED products within a range (referred to as proportion). Labelling of lower-ED products resulted in a small but significant decrease (-4.2 kcal/100 g, 95% CIs -7.8 to -0.6) in the ED of the shopping basket. Increasing the proportion of lower-ED products significantly decreased the ED of the shopping basket (-17 kcal/100 g, 95% CIs -21 to -14). There was no evidence that the effect of either intervention was moderated by SEP. Thus, both types of intervention decreased the ED of foods selected in an online experimental supermarket. There was no evidence that the effectiveness of either intervention differed in people of lower vs. higher SEP.",2020,Reducing the energy density (ED) of product selections made during online supermarket food shopping has potential to decrease energy intake.,"['Online Food Shopping', 'High- and Low-Socioeconomic Position Participants', '899 UK adults of lower and higher socioeconomic position (SEP) who completed a shopping task in an online experimental supermarket']",['ED of shopping basket selections: labelling lower-ED products'],['energy density (ED'],"[{'cui': 'C0557779', 'cui_str': 'Food shop'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0150768', 'cui_str': 'Shopping'}, {'cui': 'C0557778', 'cui_str': 'Supermarket'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0041472', 'cui_str': 'Murine typhus'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0178587', 'cui_str': 'Density'}]",899.0,0.0729249,Reducing the energy density (ED) of product selections made during online supermarket food shopping has potential to decrease energy intake.,"[{'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Marty', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool L69 7ZA, UK.'}]",Nutrients,['10.3390/nu12123618']
2973,33255478,The Development of a Sleep Intervention for Firefighters: The FIT-IN (Firefighter's Therapy for Insomnia and Nightmares) Study.,"Background : Firefighters are vulnerable to irregular sleep patterns and sleep disturbance due to work characteristics such as shift work and frequent dispatch. However, there are few studies investigating intervention targeting sleep for firefighters. This preliminary study aimed to develop and test a sleep intervention, namely FIT-IN (Firefighter's Therapy for Insomnia and Nightmares), which was based on existing evidence-based treatment tailored to firefighters in consideration of their occupational characteristics. Methods : This study implemented a single-group pre-post study design, utilizing an intervention developed based on brief behavior therapy for insomnia with imagery rehearsal therapy components. FIT-IN consisted of a total of three sessions (two face-to-face group sessions and one telephone session). Participants were recruited from Korean fire stations, and a total of 39 firefighters participated. Participants completed a sleep diary for two weeks, as well as the following questionnaires to assess their sleep and psychological factors: insomnia severity index (ISI), disturbing dream and nightmare severity index (DDNSI), Epworth sleepiness scale (ESS), depressive symptom inventory-suicidality subscale (DSI), and Patient Health Questionnaire-9 (PHQ-9). These questionnaires were administered before the first session and at the end of the second session. Results : The FIT-IN program produced improvements in sleep indices. There was a significant increase in sleep efficiency ( p < 0.01), and a decrease in sleep onset latency, number of awakenings, and time in bed ( p < 0.05), as derived from weekly sleep diaries. In addition, significant decreases were shown for insomnia ( p < 0.001) and nightmare severity ( p < 0.01). Conclusion : There were significant improvements in sleep and other clinical indices (depression, PTSD scores) when comparing pre-and post-intervention scores. FIT-IN may be a feasible and practical option in alleviating sleep disturbance in this population. Further studies will be needed to ascertain FIT-IN's effectiveness.",2020,"There was a significant increase in sleep efficiency ( p < 0.01), and a decrease in sleep onset latency, number of awakenings, and time in bed ( p < 0.05), as derived from weekly sleep diaries.","['Participants were recruited from Korean fire stations, and a total of 39 firefighters participated', 'Insomnia and Nightmares', 'Firefighters']","[""sleep intervention, namely FIT-IN (Firefighter's Therapy"", 'imagery rehearsal therapy components']","['sleep and psychological factors: insomnia severity index (ISI), disturbing dream and nightmare severity index (DDNSI), Epworth sleepiness scale (ESS), depressive symptom inventory-suicidality subscale (DSI), and Patient Health Questionnaire-9', 'nightmare severity', 'insomnia', 'sleep efficiency', 'sleep indices', 'sleep onset latency, number of awakenings, and time in bed', 'sleep and other clinical indices (depression, PTSD scores']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0449432', 'cui_str': 'Component'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0013117', 'cui_str': 'Dream'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",39.0,0.0314276,"There was a significant increase in sleep efficiency ( p < 0.01), and a decrease in sleep onset latency, number of awakenings, and time in bed ( p < 0.05), as derived from weekly sleep diaries.","[{'ForeName': 'Eun Hee', 'Initials': 'EH', 'LastName': 'Jang', 'Affiliation': 'Department of Psychology, Sungshin University, Seoul 02844, Korea.'}, {'ForeName': 'Yujin', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Department of Psychology, Sungshin University, Seoul 02844, Korea.'}, {'ForeName': 'Yeji', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Department of Psychology, Sungshin University, Seoul 02844, Korea.'}, {'ForeName': 'Sangha', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Psychology, Sungshin University, Seoul 02844, Korea.'}, {'ForeName': 'Yeonsoon', 'Initials': 'Y', 'LastName': 'Ahn', 'Affiliation': 'Department of Preventive Medicine, Yonsei University Wonju College of Medicine, Wonju26426, Korea.'}, {'ForeName': 'Kyoung Sook', 'Initials': 'KS', 'LastName': 'Jeong', 'Affiliation': 'Department of Occupational and Environmental Medicine, Wonju Severance Christian Hospital, Wonju 26426, Korea.'}, {'ForeName': 'Tae-Won', 'Initials': 'TW', 'LastName': 'Jang', 'Affiliation': 'Department of Occupational and Environmental Medicine, Hanyang University College of Medicine, Seoul 04763, Korea.'}, {'ForeName': 'Hyejin', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Ilsang Psychological Services, IPS, Seoul 05685, Korea.'}, {'ForeName': 'Eunha', 'Initials': 'E', 'LastName': 'Jung', 'Affiliation': 'Ilsang Psychological Services, IPS, Seoul 05685, Korea.'}, {'ForeName': 'Shift Work', 'Initials': 'SW', 'LastName': 'Disorder Study Group', 'Affiliation': ''}, {'ForeName': 'Seockhoon', 'Initials': 'S', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Sooyeon', 'Initials': 'S', 'LastName': 'Suh', 'Affiliation': 'Department of Psychology, Sungshin University, Seoul 02844, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17238738']
2974,33255353,The Effects of a Mediterranean Diet Intervention on Targeted Plasma Metabolic Biomarkers among US Firefighters: A Pilot Cluster-Randomized Trial.,"Metabolomics is improving the understanding of the mechanisms of the health effects of diet. Previous research has identified several metabolites associated with the Mediterranean Diet (MedDiet), but knowledge about longitudinal changes in metabolic biomarkers after a MedDiet intervention is scarce. A subsample of 48 firefighters from a cluster-randomized trial at Indianapolis fire stations was randomly selected for the metabolomics study at 12 months of follow up (time point 1), where Group 1 ( n = 24) continued for another 6 months in a self-sustained MedDiet intervention, and Group 2 ( n = 24), the control group at that time, started with an active MedDiet intervention for 6 months (time point 2). A total of 225 metabolites were assessed at the two time points by using a targeted NMR platform. The MedDiet score improved slightly but changes were non-significant (intervention: 24.2 vs. 26.0 points and control group: 26.1 vs. 26.5 points). The MedDiet intervention led to favorable changes in biomarkers related to lipid metabolism, including lower LDL-C, ApoB/ApoA1 ratio, remnant cholesterol, M-VLDL-CE; and higher HDL-C, and better lipoprotein composition. This MedDiet intervention induces only modest changes in adherence to the MedDiet and consequently in metabolic biomarkers. Further research should confirm these results based on larger study samples in workplace interventions with powerful study designs.",2020,The MedDiet score improved slightly but changes were non-significant (intervention: 24.2 vs. 26.0 points and control group: 26.1 vs. 26.5 points).,"['US Firefighters', 'A subsample of 48 firefighters from a cluster-randomized trial at Indianapolis fire stations']","['active MedDiet intervention', 'Mediterranean Diet Intervention']","['Plasma Metabolic Biomarkers', 'MedDiet score', 'lower LDL-C, ApoB/ApoA1 ratio, remnant cholesterol, M-VLDL-CE; and higher HDL-C, and better lipoprotein composition']","[{'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0853085', 'cui_str': 'Low density lipoprotein decreased'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C1677784', 'cui_str': 'APOA1 protein, human'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",225.0,0.0163991,The MedDiet score improved slightly but changes were non-significant (intervention: 24.2 vs. 26.0 points and control group: 26.1 vs. 26.5 points).,"[{'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Sotos-Prieto', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid, IdiPaz (Instituto de Investigación Sanitaria Hospital Universitario La Paz), Calle del Arzobispo Morcillo 4, 28029 Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA, University of Navarra, 31009 Pamplona, Spain.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Epidemiology, Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, IN 46202, USA.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Christophi', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Mofatt', 'Affiliation': 'National Institute for Public Safety Health, Indianapolis, IN 46204, USA.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rodriguez-Artalejo', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, Universidad Autónoma de Madrid, IdiPaz (Instituto de Investigación Sanitaria Hospital Universitario La Paz), Calle del Arzobispo Morcillo 4, 28029 Madrid, Spain.'}, {'ForeName': 'Stefanos N', 'Initials': 'SN', 'LastName': 'Kales', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}]",Nutrients,['10.3390/nu12123610']
2975,33255350,High Molecular Weight Hyaluronan Promotes Corneal Nerve Growth in Severe Dry Eyes.,"The purpose of this study was to investigate the effect of high molecular weight hyaluronan (HMWHA) eye drops on subbasal corneal nerves in patients suffering from severe dry eye disease (DED) and to evaluate the damage of subbasal corneal nerves associated with severe DED. Designed as an international, multicenter study, 16 patients with symptoms of at least an Ocular Surface Disease Index (OSDI) score of 33, and corneal fluorescein staining (CFS) of at least Oxford grade 3, were included and randomized into two study arms. The control group continued to use their individual optimum artificial tears over the study period of eight weeks; in the verum group, the artificial tears were substituted by eye drops containing 0.15% HMWHA. At the baseline visit, and after eight weeks, the subbasal nerve plexus of 16 patients were assessed by confocal laser scanning microscopy (CSLM). The images were submitted to a masked reading center for evaluation. Results showed a significant increase of total nerve fiber lengths (CNFL) in the HMWHA group ( p = 0.030) when compared to the control group, where the total subbasal CNFL did not significantly change from baseline to week 8. We concluded that in severe DED patients, HMWHA from topically applied eye drops could cross the epithelial barrier and reach the subbasal nerve plexus, where it exercised a trophic effect.",2020,"Results showed a significant increase of total nerve fiber lengths (CNFL) in the HMWHA group ( p = 0.030) when compared to the control group, where the total subbasal CNFL did not significantly change from baseline to week 8.","['patients suffering from severe dry eye disease (DED', '16 patients with symptoms of at least an Ocular Surface Disease Index (OSDI) score of 33, and corneal fluorescein staining (CFS) of at least Oxford grade 3', 'Severe Dry Eyes']","['artificial tears were substituted by eye drops containing 0.15% HMWHA', 'high molecular weight hyaluronan (HMWHA) eye drops']","['total nerve fiber lengths (CNFL', 'subbasal corneal nerves', 'total subbasal CNFL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}]","[{'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027749', 'cui_str': 'Nerve fiber'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}]",16.0,0.019477,"Results showed a significant increase of total nerve fiber lengths (CNFL) in the HMWHA group ( p = 0.030) when compared to the control group, where the total subbasal CNFL did not significantly change from baseline to week 8.","[{'ForeName': 'Gysbert-Botho', 'Initials': 'GB', 'LastName': 'van Setten', 'Affiliation': 'Department of Clininical Neuroscience, St. Eriks Eye Hospital, Karolinska Institutet, 11282 Stockholm, Sweden.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Stachs', 'Affiliation': 'Department of Ophthalmology, University Medical Center Rostock, 18057 Rostock, Germany.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Dupas', 'Affiliation': 'Quinze-Vingts National Eye Hospital & Vision Institute, 75571 Paris, France.'}, {'ForeName': 'Semra Akkaya', 'Initials': 'SA', 'LastName': 'Turhan', 'Affiliation': 'Department of Ophthalmology, Marmara University School of Medicine, 34899 Istanbul, Turkey.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Seitz', 'Affiliation': 'Department of Ophthalmology, Saarland University Medical Center, 66421 Homburg/Saar, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Reitsamer', 'Affiliation': 'Department of Ophthalmology & Department of Experimental Ophthalmology and Glaucoma Research, University Clinic Salzburg, Paracelsus Medical University, 5020 Salzburg, Austria.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Winter', 'Affiliation': 'Institute of Anatomy, Medical Faculty, University of Leipzig, 04103 Leipzig, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Horwath-Winter', 'Affiliation': 'Department of Ophthalmology, Medical University Graz, 8036 Graz, Austria.'}, {'ForeName': 'Rudolf F', 'Initials': 'RF', 'LastName': 'Guthoff', 'Affiliation': 'Department of Ophthalmology, University Medical Center Rostock, 18057 Rostock, Germany.'}, {'ForeName': 'Wolfgang G K', 'Initials': 'WGK', 'LastName': 'Müller-Lierheim', 'Affiliation': 'CORONIS GmbH, 81241 Munich, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9123799']
2976,33255249,Epigenetic Patterns in Five-Year-Old Children Exposed to a Low Glycemic Index Dietary Intervention during Pregnancy: Results from the ROLO Kids Study.,"A range of in utero and early-life factors can influence offspring epigenetics, particularly DNA methylation patterns. This study aimed to investigate the influence of a dietary intervention and factors in pregnancy on offspring epigenetic profile at five years of age. We also explored associations between body composition and methylation profile in a cross-sectional analysis. Sixty-three five-year-olds were selected from the ROLO Kids Study, a Randomized controlled trial Of a LOw glycemic index dietary intervention from the second trimester of pregnancy. DNA methylation was investigated in 780,501 CpG sites in DNA isolated from saliva. Principal component analysis identified no association between maternal age, weight, or body mass index (BMI) during pregnancy and offspring DNA methylation ( p > 0.01). There was no association with the dietary intervention during pregnancy, however, gene pathway analysis identified functional clusters involved in insulin secretion and resistance that differed between the intervention and control. There were no associations with child weight or adiposity at five years of age; however, change in weight from six months was associated with variation in methylation. We identified no evidence of long-lasting influences of maternal diet or factors on DNA methylation at age five years. However, changes in child weight were associated with the methylome in childhood.",2020,"There was no association with the dietary intervention during pregnancy, however, gene pathway analysis identified functional clusters involved in insulin secretion and resistance that differed between the intervention and control.","['Five-Year-Old Children', 'during Pregnancy', 'pregnancy on offspring epigenetic profile at five years of age', 'Sixty-three five-year-olds were selected from the ROLO Kids Study']","['Low Glycemic Index Dietary Intervention', 'dietary intervention', 'LOw glycemic index dietary intervention']","['insulin secretion and resistance', 'maternal age, weight, or body mass index (BMI) during pregnancy and offspring DNA methylation', 'child weight or adiposity', 'child weight']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0024915', 'cui_str': 'Maternal age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]",,0.0289313,"There was no association with the dietary intervention during pregnancy, however, gene pathway analysis identified functional clusters involved in insulin secretion and resistance that differed between the intervention and control.","[{'ForeName': 'Aisling A', 'Initials': 'AA', 'LastName': 'Geraghty', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, D02 YH21 Dublin 2, Ireland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Sexton-Oates', 'Affiliation': ""Cancer and Disease Epigenetics, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Eileen C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, D02 YH21 Dublin 2, Ireland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saffery', 'Affiliation': ""Cancer and Disease Epigenetics, Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, D02 YH21 Dublin 2, Ireland.'}]",Nutrients,['10.3390/nu12123602']
2977,33254620,Persistent organic pollutants exposure in newborn dried blood spots and infant weight status: A case-control study of low-income Hispanic mother-infant pairs.,"Persistent organic pollutants (POPs) are believed to alter metabolic homeostasis during fetal development, leading to childhood obesity. However, limited studies have explored how fetal chemical exposures relate to birth and infant weight outcomes in low-income Hispanic families at the highest risk of obesity. Therefore, we sought to determine associations between neonatal POPs exposure measured in newborn dried blood spots (DBS) and prenatal diet quality, birth weight, and overweight status at 18 months old. We conducted a case-control study nested within the Starting Early Program randomized controlled trial comparing POPs concentrations in infants with healthy weight (n = 46) and overweight status (n = 52) at age 18 months. Three categories of POPs, organochlorine pesticides (OCPs), polybrominated diphenyl ethers (PBDEs) and perfluoroalkyl substances (PFASs) were measured in archived newborn DBS. We assessed correlations between prenatal diet quality and neonatal POPs concentrations. Multivariable regression analyses examined associations between POPs (dichotomized at the mean) and birth weight z-score and weight status at 18 months, controlling for confounders. Seven of eight chemicals had detectable levels in greater than 94% of the sample. Higher protein, sodium and refined grain intake during pregnancy were correlated with lower POPs in newborn DBS. We found that high concentrations of perfluorooctanesulfonate (unstandardized coefficient [B]: -0.62, 95% confidence interval [CI]: -0.96 to -0.29) and perfluorohexanesulfate (B: -0.65, 95% CI: -0.99 to -0.31) were related to lower birth weight z-scores compared to those with low concentrations. We did not find associations between PBDEs, OCPs, and the other PFASs with birth weight z-scores, or between any POPs and weight status at 18 months. In conclusion, two PFASs were associated with lower birth weight, an important indicator of child health and growth, although direct associations with infant overweight status were not found. Whether neonatal POPs exposures contribute to economic and ethnic disparities in early obesity remains unclear.",2020,"We did not find associations between PBDEs, OCPs, and the other PFASs with birth weight z-scores, or between any POPs and weight status at 18 months.","['infants with healthy weight (n\xa0=\xa046) and overweight status (n\xa0=\xa052) at age 18 months', 'newborn dried blood spots and infant weight status', 'low-income Hispanic mother-infant pairs']",['perfluorohexanesulfate '],"['birth weight z-scores', 'Higher protein, sodium and refined grain intake', 'prenatal diet quality and neonatal POPs concentrations', 'lower birth weight', 'POPs, organochlorine pesticides (OCPs), polybrominated diphenyl ethers (PBDEs) and perfluoroalkyl substances (PFASs', 'newborn dried blood spots (DBS) and prenatal diet quality, birth weight, and overweight status', 'birth weight z-score and weight status']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",[],"[{'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0014417', 'cui_str': 'Pollutants, Environmental'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0392143', 'cui_str': 'Organochlorine pesticide'}, {'cui': 'C0012526', 'cui_str': 'Diphenyl Ethers'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",,0.0316238,"We did not find associations between PBDEs, OCPs, and the other PFASs with birth weight z-scores, or between any POPs and weight status at 18 months.","[{'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Gross', 'Affiliation': 'Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA; Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA. Electronic address: Rachel.Gross@nyulangone.org.'}, {'ForeName': 'Akhgar', 'Initials': 'A', 'LastName': 'Ghassabian', 'Affiliation': 'Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA; Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA; Department of Environmental Medicine, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Vandyousefi', 'Affiliation': 'Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Messito', 'Affiliation': 'Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Chongjing', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Wadsworth Center, New York State Department of Health, Albany, NY, USA.'}, {'ForeName': 'Kurunthachalam', 'Initials': 'K', 'LastName': 'Kannan', 'Affiliation': 'Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA; Wadsworth Center, New York State Department of Health, Albany, NY, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Trasande', 'Affiliation': 'Department of Pediatrics, New York University Grossman School of Medicine, New York, NY, USA; Department of Population Health, New York University Grossman School of Medicine, New York, NY, USA; Department of Environmental Medicine, New York University Grossman School of Medicine, New York, NY, USA; NYU Wagner School of Public Service, New York, NY, USA; NYU College of Global Public Health, New York, NY, USA.'}]","Environmental pollution (Barking, Essex : 1987)",['10.1016/j.envpol.2020.115427']
2978,33254288,[Application of 3D U-net in automatic segmentation of middle ear surgery structures in temporal bone CT].,"Objective: To study the feasibility of fully automatic segmentation of labyrinth, facial nerve and ossicles in clinical routine temporal bone CT images based on 3D U-net neural network. Method: Clinical data were divided into two groups: ①Normal group: data were randomly assigned from 30 patients for routine temporal bone CT examination; ②Abnormal group: cochlear, ossicles and facial nerve morphology variation of 1 case each. The structures of facial nerve, labyrinth and ossicles were manually initial segmented and fine segmented by 2 clinicians with Mimics 20.0. Three-dimensional convolutional neural network(3D U-Net) was selected to conduct deep learning on the same data. The dice similarity coefficient(DSC) was used as the evaluation index. Result: The 3D U-net neural network was used to automatically segment the labyrinth, ossicles and facial nerve in the routine temporal bone CT. In the normal group, the DSC of labyrinth, ossicles and facial nerve were 0.79±0.03, 0.64±0.05 and 0.49±0.09, respectively. In the abnormal group, the DSC of these structures were 0.71, 0.54 and 0.40. Conclusion: According to the anatomical characteristics of the temporal bone, the labyrinth, ossicles and the facial nerve can be totally automatic segmented by 3D U-net neural network, and the accuracy was closed to that of manual segmentation. This method is feasible, fast and accurate.",2020,"In the normal group, the DSC of labyrinth, ossicles and facial nerve were 0.79±0.03, 0.64±0.05 and 0.49±0.09, respectively.",['middle ear surgery structures in temporal bone CT'],"['routine temporal bone CT examination; ②Abnormal group: cochlear, ossicles and facial nerve morphology variation of 1 case each', '3D U-net']","['DSC of labyrinth, ossicles and facial nerve']","[{'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0039484', 'cui_str': 'Temporal bone structure'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039484', 'cui_str': 'Temporal bone structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009195', 'cui_str': 'Cochlear structure'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}]","[{'cui': 'C0022889', 'cui_str': 'Inner ear structure'}, {'cui': 'C0015462', 'cui_str': 'Facial nerve structure'}]",30.0,0.0243651,"In the normal group, the DSC of labyrinth, ossicles and facial nerve were 0.79±0.03, 0.64±0.05 and 0.49±0.09, respectively.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery,Third Hospital,Peking University,Beijing,100191,China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'School of Mechanical Engineering and Automation,Beihang University.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'DU', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery,Third Hospital,Peking University,Beijing,100191,China.'}, {'ForeName': 'Junchen', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Mechanical Engineering and Automation,Beihang University.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery,Third Hospital,Peking University,Beijing,100191,China.'}, {'ForeName': 'Shilong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery,Third Hospital,Peking University,Beijing,100191,China.'}, {'ForeName': 'Furong', 'Initials': 'F', 'LastName': 'Ma', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery,Third Hospital,Peking University,Beijing,100191,China.'}]","Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology, head, and neck surgery",['10.13201/j.issn.2096-7993.2020.10.002']
2979,33254239,The clinical and cost effectiveness of splints for thumb base osteoarthritis: a randomized controlled clinical trial.,"OBJECTIVES
To investigate the clinical effectiveness, efficacy and cost effectiveness of splints (orthoses) in people with symptomatic basal thumb joint OA (BTOA).
METHODS
A pragmatic, multicentre parallel group randomized controlled trial at 17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction. We randomized participants (1:1:1) using a computer-based minimization system to one of three treatment groups: a therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS). Participants were blinded to group allocation, received 90 min therapy over 8 weeks and were followed up for 12 weeks from baseline. Australian/Canadian (AUSCAN) hand pain at 8 weeks was the primary outcome, using intention to treat analysis. We calculated costs of treatment.
RESULTS
We randomized 349 participants to SSM (n = 116), SSM+S (n = 116) or SSM+PS (n = 117) and 292 (84%) provided AUSCAN Osteoarthritis Hand Index hand pain scores at the primary end point (8 weeks). All groups improved, with no mean treatment difference between groups: SSM+S vs SSM -0.5 (95% CI: -1.4, 0.4), P = 0.255; SSM+PS vs SSM -0.1 (95% CI: -1.0, 0.8), P = 0.829; and SSM+S vs SSM+PS -0.4 (95% CI: -1.4, 0.5), P = 0.378. The average 12-week costs were: SSM £586; SSM+S £738; and SSM+PS £685.
CONCLUSION
There was no additional benefit of adding a thumb splint to a high-quality evidence-based, supported self-management programme for thumb OA delivered by therapists.
TRIAL REGISTRATION
ISRCTN 54744256 (http://www.isrctn.com/ISRCTN54744256).",2020,"All groups improved, with no mean treatment difference between groups:","['17 National Health Service (NHS) hospital departments recruited adults with symptomatic BTOA and at least moderate hand pain and dysfunction', '349 participants to SSM (n\u2009=\u2009116', 'thumb base osteoarthritis', 'people with symptomatic basal thumb joint OA (BTOA']","['therapist supported self-management programme (SSM), a therapist supported self-management programme plus a verum thumb splint (SSM+S), or a therapist supported self-management programme plus a placebo thumb splint (SSM+PS', 'SSM+S', 'splints (orthoses', 'SSM+S vs SSM+PS', 'SSM+PS']",['AUSCAN Osteoarthritis Hand Index hand pain scores'],"[{'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0019961', 'cui_str': 'Hospital department'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0459473', 'cui_str': 'Thumb joint structure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0239833', 'cui_str': 'Hand pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0239833', 'cui_str': 'Hand pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",349.0,0.242708,"All groups improved, with no mean treatment difference between groups:","[{'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Health Sciences, University of Southampton, Southampton.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Barratt', 'Affiliation': 'Health Sciences, University of Southampton, Southampton.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Rombach', 'Affiliation': 'Oxford Clinical Trials Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS).'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Arden', 'Affiliation': 'Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis, University of Southampton.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Barbosa Bouças', 'Affiliation': 'Department of Life Sciences, Brunel University London, Uxbridge.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bradley', 'Affiliation': 'Hand Therapy Unit, Poole Hospital NHS Trust, Poole.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Centre for Sport, Exercise and Osteoarthritis Research Versus Arthritis, University of Southampton.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS).'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'Elizabeth Blackwell Institute for Health Research, University of Bristol, Bristol.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Hislop-Lennie', 'Affiliation': 'Health Sciences, University of Southampton, Southampton.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Hutt-Greenyer', 'Affiliation': 'Patient and Public Involvement Group Health Sciences, University of Southampton, Southampton.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Jansen', 'Affiliation': 'Pulvertaft Hand Centre, Royal Derby Hospital, Derby.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Luengo-Fernadez', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Department of Sport, Health Sciences and Social Work, Oxford Brookes University, Oxford.'}, {'ForeName': 'Krysia', 'Initials': 'K', 'LastName': 'Dziedzic', 'Affiliation': 'Primary Care Centre of Excellence Versus Arthritis, School of Primary Community and Social Care, Keele University, Staffordshire.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa726']
2980,33254237,Sustained Lung Inflation in Pre-term Infants at Birth: A Randomized Controlled Trial.,"BACKGROUND
Invasive mechanical ventilation (IMV) of pre-term infants may be associated with high rate of mortality and iatrogenic complications in low- and middle-income countries. Sustained lung inflation (SLI) may help to reduce their need for IMV.
METHODS
This randomized controlled trial included 160 infants with gestational age (GA) ≥27 and ≤32 weeks who were randomly assigned to receive either SLI; using a pressure of 20 cmH2O for 15 s followed by nasal continuous positive airway pressure (CPAP) of 5 cmH2O or nasal CPAP alone, through an appropriate mask and a T-piece resuscitator. Primary outcome was the need for IMV in the first 72 h of life.
RESULTS
There was no difference in the primary outcome between SLI group; 55% (44 out of 80) and the control group; 65% (52 out of 80) [odds ratio (OR): 0.623, 95% confidence interval (CI): 0.33-1.18; p = 0.145]. However, SLI significantly reduced the primary outcome in the sicker infants; who had clinical eligibility criteria (CEC; OR: 0.224, 95% CI: 0.076-0.663; p = 0.005) and in the smaller babies; whose GA was <30 weeks (OR: 0.183, 95% CI: 0.053-0.635; p = 0.005).
CONCLUSION
SLI was not harmful. Although, it did not lead to reduction in the need for IMV in the first 72 h of life in pre-term infants with GA ≥27 and ≤32 weeks, SLI reduced this outcome in the subgroup of infants with CEC and those with GA <30 weeks. Future trials are needed to investigate the effect of SLI on these two subgroups.
TRIAL REGISTRATION
Clinical trials.gov, NCT03518762. https://www.clinicaltrials.gov/ct2/show/NCT03518762?term=NCT03518762&rank=1.",2020,"Although, it did not lead to reduction in the need for IMV in the first 72 h of life in pre-term infants with GA ≥27 and ≤32 weeks, SLI reduced this outcome in the subgroup of infants with CEC and those with GA <30 weeks.","['160 infants with gestational age (GA) ≥27 and ≤32\u2009weeks', 'Pre-term Infants at Birth']","['Invasive mechanical ventilation (IMV', 'Sustained lung inflation (SLI', 'SLI', 'pressure of 20\u2009cmH2O for 15\u2009s followed by nasal continuous positive airway pressure (CPAP) of 5\u2009cmH2O or nasal CPAP alone, through an appropriate mask and a T-piece resuscitator']","['need for IMV in the first 72\u2009h of life', 'Sustained Lung Inflation']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C1438152', 'cui_str': 'SHC2 protein, human'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439476', 'cui_str': 'cmH2O'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0182998', 'cui_str': 'Resuscitator'}]","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}]",160.0,0.350538,"Although, it did not lead to reduction in the need for IMV in the first 72 h of life in pre-term infants with GA ≥27 and ≤32 weeks, SLI reduced this outcome in the subgroup of infants with CEC and those with GA <30 weeks.","[{'ForeName': 'Walaa A', 'Initials': 'WA', 'LastName': 'Abuel Hamd', 'Affiliation': 'Neonatology Unit, Gynecology and Obstetrics Department, Kasr El Ainy Hospital, 11562 Cairo, Egypt.'}, {'ForeName': 'Douaa E', 'Initials': 'DE', 'LastName': 'El Sherbiny', 'Affiliation': 'Neonatology Unit, Gynecology and Obstetrics Department, Kasr El Ainy Hospital, 11562 Cairo, Egypt.'}, {'ForeName': 'Salma Z', 'Initials': 'SZ', 'LastName': 'El Houchi', 'Affiliation': 'Neonatology Unit, Gynecology and Obstetrics Department, Kasr El Ainy Hospital, 11562 Cairo, Egypt.'}, {'ForeName': 'Iman F', 'Initials': 'IF', 'LastName': 'Iskandar', 'Affiliation': 'Neonatology Unit, Gynecology and Obstetrics Department, Kasr El Ainy Hospital, 11562 Cairo, Egypt.'}, {'ForeName': 'Dina M', 'Initials': 'DM', 'LastName': 'Akmal', 'Affiliation': 'Neonatology Unit, Gynecology and Obstetrics Department, Kasr El Ainy Hospital, 11562 Cairo, Egypt.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmaa097']
2981,33254235,Safety and efficacy of fostamatinib in rheumatoid arthritis patients with an inadequate response to methotrexate in phase II OSKIRA-ASIA-1 and OSKIRA-ASIA-1X study.,"OBJECTIVE
The primary objectives of two phase II studies of fostamatinib were to evaluate efficacy (OSKIRA-Asia-1: NCT01569074) and long-term safety/tolerability (OSKIRA-Asia-1X: NCT01640054) in patients from Asia with active RA despite MTX treatment.
METHODS
OSKIRA-Asia-1 was a 12-week, multicentre, double-blind, placebo-controlled, parallel-group study. Patients were randomized to receive one of four fostamatinib doses (groups A-D; n = 31, 33, 33, 33) or placebo (group E; n = 33). OSKIRA-Asia-1X was a long-term extension study (100 mg fostamatinib qd) of patients who completed OSKIRA-Asia-1. RA signs and symptoms were measured by ACR response criteria and DAS based on a 28-joint count. Physical function status was assessed with the HAQ-Disability Index. Safety findings were monitored.
RESULTS
In OSKIRA-Asia-1, fostamatinib revealed numerical improvements in ACR 20% response (ACR20) at week 12 in group A (100 mg bid) and group B (100 mg bid, then 150 mg qd) vs placebo. Statistically significant improvements in ACR20 and ACR50 at week 8 and in ACR70 at week 12, and statistically significant achievement in low disease activity (defined as DAS based on a 28-joint count ≤3.2 based on C-reactive protein) occurred in groups A and B. Improvement in physical function was numerically higher in group A. The most common adverse events were hypertension, diarrhoea and neutropenia. In OSKIRA-Asia-1X, the most common adverse events were nasopharyngitis, hypertension, RA and neutropenia.
CONCLUSION
Fostamatinib achieved both statistically and clinically significant improvements in RA signs and symptoms. The safety and tolerability of fostamatinib (plus MTX) were consistent with previous studies.
TRIAL REGISTRATION
OSKIRA-Asia-1 trial registration: https://clinicaltrials.gov, NCT01569074; OSKIRA-Asia-1X trial registration: https://clinicaltrials.gov, NCT01640054.",2020,"Statistically significant improvements in ACR20 and ACR50 at week 8 and in ACR70 at week 12, and statistically significant achievement in low disease activity (defined as DAS based on a 28-joint count ≤3.2 based on C-reactive protein) occurred in groups A and B. Improvement in physical function was numerically higher in group A.","['patients from Asia with active RA despite MTX treatment', 'rheumatoid arthritis patients with an inadequate response to']","['methotrexate', 'fostamatinib (plus MTX', 'placebo']","['low disease activity', 'safety and tolerability', 'ACR20 and ACR50', 'nasopharyngitis, hypertension, RA and neutropenia', 'RA signs and symptoms', 'physical function', 'Safety and efficacy', 'hypertension, diarrhoea and neutropenia', 'Physical function status', 'HAQ-Disability Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C2713632', 'cui_str': 'fostamatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.151731,"Statistically significant improvements in ACR20 and ACR50 at week 8 and in ACR70 at week 12, and statistically significant achievement in low disease activity (defined as DAS based on a 28-joint count ≤3.2 based on C-reactive protein) occurred in groups A and B. Improvement in physical function was numerically higher in group A.","[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Millson', 'Affiliation': 'AstraZeneca R&D, Macclesfield, UK.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Iwata', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Nakayamada', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa732']
2982,33254224,Following instructions in working memory: do older adults show the enactment advantage?,"OBJECTIVES
In young adults, the ability to verbally recall instructions in working memory is enhanced if the sequences are physically enacted by the participant (self-enactment) or the experimenter (demonstration) during encoding. Here we examine the effects of self-enactment and demonstration at encoding on working memory performance in older and younger adults.
METHOD
50 young (18-23 years) and 40 older (60-89 years) adults listened to sequences of novel action-object pairs before verbally recalling them in the correct order. There were three different encoding conditions: spoken only, spoken + demonstration, spoken + self-enactment. We included two different levels of difficulty to investigate whether task complexity moderated the effect of encoding condition and whether this differed between age groups.
RESULTS
Relative to the spoken only condition, demonstration significantly improved young and older adults' serial recall performance, but self-enactment only enhanced performance in the young adults, and this boost was smaller than the one gained through demonstration.
DISCUSSION
Our findings suggest that additional spatial-motoric information is beneficial for older adults when the actions are demonstrated to them, but not when the individual must enact the instructions themselves.",2020,"In young adults, the ability to verbally recall instructions in working memory is enhanced if the sequences are physically enacted by the participant (self-enactment) or the experimenter (demonstration) during encoding.","['young adults', 'older adults', 'older and younger adults', '50 young (18-23 years) and 40 older (60-89 years) adults']","['listened to sequences of novel action-object pairs before verbally recalling them in the correct order', 'self-enactment and demonstration at encoding']","[""spoken only condition, demonstration significantly improved young and older adults' serial recall performance""]","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0227086,"In young adults, the ability to verbally recall instructions in working memory is enhanced if the sequences are physically enacted by the participant (self-enactment) or the experimenter (demonstration) during encoding.","[{'ForeName': 'Rachel O', 'Initials': 'RO', 'LastName': 'Coats', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Amanda H', 'Initials': 'AH', 'LastName': 'Waterman', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Ryder', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Atkinson', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, West Yorkshire, UK.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Allen', 'Affiliation': 'School of Psychology, University of Leeds, Leeds, West Yorkshire, UK.'}]","The journals of gerontology. Series B, Psychological sciences and social sciences",['10.1093/geronb/gbaa214']
2983,33254172,A Phase 2 Randomized Trial of Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation for Parkinson's Disease.,"OBJECTIVE
Asleep deep brain stimulation (DBS) for Parkinson's disease (PD) is being performed more frequently; however, motor outcomes and safety of asleep DBS have never been assessed in a prospective randomized trial.
METHODS
We conducted a prospective, randomized, noncomparative trial to assess the motor outcomes of asleep DBS. Leads were implanted in the subthalamic nucleus (STN) according to probabilistic stereotactic coordinates with a surgical robot under O-arm© imaging guidance under either general anesthesia without microelectrode recordings (MER) (20 patients, asleep group) or local anesthesia with MER and clinical testing (9 patients, awake group).
RESULTS
The mean motor improvement rates on the Unified Parkinson's Disease Rating Scale Part III (UPDRS-3) between OFF and ON stimulation without medication were 52.3% (95% CI: 45.4-59.2%) in the asleep group and 47.0% (95% CI: 23.8-70.2%) in the awake group, 6 months after surgery. Except for a subcutaneous hematoma, we did not observe any complications related to the surgery. Three patients (33%) in the awake group and 8 in the asleep group (40%) had at least one side effect potentially linked with neurostimulation.
CONCLUSIONS
Owing to its randomized design, our study supports the hypothesis that motor outcomes after asleep STN-DBS in PD may be noninferior to the standard awake procedure.",2020,"The mean motor improvement rates on the Unified Parkinson's Disease Rating Scale Part III (UPDRS-3) between OFF and ON stimulation without medication were 52.3% (95% CI: 45.4-59.2%) in the asleep group and 47.0% (95% CI: 23.8-70.2%) in the awake group, 6 months after surgery.","[""Parkinson's disease (PD"", ""Parkinson's Disease""]","['Asleep deep brain stimulation (DBS', 'Asleep versus Awake Subthalamic Nucleus Deep Brain Stimulation', 'surgical robot under O-arm© imaging guidance under either general anesthesia without microelectrode recordings (MER) (20 patients, asleep group) or local anesthesia with MER and clinical testing']","[""mean motor improvement rates on the Unified Parkinson's Disease Rating Scale Part III (UPDRS-3) between OFF and ON stimulation without medication""]","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0442972', 'cui_str': 'Imaging guidance'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0025973', 'cui_str': 'Electrodes, Miniaturized'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",,0.0745151,"The mean motor improvement rates on the Unified Parkinson's Disease Rating Scale Part III (UPDRS-3) between OFF and ON stimulation without medication were 52.3% (95% CI: 45.4-59.2%) in the asleep group and 47.0% (95% CI: 23.8-70.2%) in the awake group, 6 months after surgery.","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Engelhardt', 'Affiliation': 'CHU de Bordeaux, Service de Neurochirurgie B, Bordeaux, France, julien.engelhardt@gmail.com.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Caire', 'Affiliation': 'Université de Limoges, CNRS, XLIM, UMR7252, Limoges, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Damon-Perrière', 'Affiliation': 'Institut des Maladies Neurodégénératives, Université de Bordeaux, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Guehl', 'Affiliation': 'Institut des Maladies Neurodégénératives, Université de Bordeaux, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Branchard', 'Affiliation': 'CHU de Bordeaux, Service de Neurochirurgie B, Bordeaux, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Auzou', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Tison', 'Affiliation': 'Institut des Maladies Neurodégénératives, Université de Bordeaux, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Wassilios G', 'Initials': 'WG', 'LastName': 'Meissner', 'Affiliation': 'Institut des Maladies Neurodégénératives, Université de Bordeaux, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Krim', 'Affiliation': 'CH de Pau, Service de Neurologie, Pau, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Bannier', 'Affiliation': 'CH de Bayonne, Service de Neurologie, Bayonne, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bénard', 'Affiliation': 'CHU Bordeaux, Pôle de Santé Publique, Clinical Epidemiology Unit (USMR), Bordeaux, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Sitta', 'Affiliation': 'CHU Bordeaux, Pôle de Santé Publique, Clinical Epidemiology Unit (USMR), Bordeaux, France.'}, {'ForeName': 'Denys', 'Initials': 'D', 'LastName': 'Fontaine', 'Affiliation': 'CHU de Nice, Service de Neurochirurgie, Nice, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Hoarau', 'Affiliation': 'Polyclinique de Navarre, Service de Neurochirurgie, Pau, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Burbaud', 'Affiliation': 'Institut des Maladies Neurodégénératives, Université de Bordeaux, UMR 5293, Bordeaux, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Cuny', 'Affiliation': 'CHU de Bordeaux, Service de Neurochirurgie B, Bordeaux, France.'}]",Stereotactic and functional neurosurgery,['10.1159/000511424']
2984,33254048,Does valence contribute to the effects of dual tasking in aversive autobiographical memory? Some unexpected findings.,"BACKGROUND AND OBJECTIVES
Lab experiments show that engaging in a working memory task while recalling an aversive memory reduces emotionality and vividness of memories. Studies targeting lab induced negative memory with valenced secondary tasks show promise, but work is needed on autobiographical memories to make it more in line with the original dual tasking research and PTSD treatment in clinical populations. In this study, we address this gap by evaluating differential effectiveness of valenced dual tasks on emotionality and vividness of aversive autobiographical memories.
METHODS
University students (N = 178) recalled an aversive autobiographical memory while rating either positive pictures, negative pictures, or while looking at a cross in the exposure only condition. Participants were randomized to one of three aforementioned conditions and rated their memories before and after each intervention on emotionality and vividness.
RESULTS
Against expectations, memories became more emotional and vivid regardless of condition. With regard to vividness, this effect was characterized by an interaction effect: memories became more vivid in the exposure only condition than in the combined dual tasking conditions. All effect sizes were small.
LIMITATIONS
Working memory load in the dual tasking conditions might have been insufficient.
CONCLUSIONS
The current study did not extend findings with regard to (valenced) dual tasking and revealed a possible sensitization effect of script driven autobiographical memory induction. Our study highlights the importance of aspects such as the total amount of exposure and characteristics of memory induction, specifically the addition of a script driven approach to the usual self-initiated memory activation in dual tasking research.",2020,"With regard to vividness, this effect was characterized by an interaction effect: memories became more vivid in the exposure only condition than in the combined dual tasking conditions.",['University students (N\xa0=\xa0178) recalled an'],"['valenced dual tasks', 'aversive autobiographical memory while rating either positive pictures, negative pictures, or while looking at a cross in the exposure only condition']",[],"[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],,0.0360541,"With regard to vividness, this effect was characterized by an interaction effect: memories became more vivid in the exposure only condition than in the combined dual tasking conditions.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'IJdema', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands. Electronic address: t.ijdema@uvt.nl.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Laceulle', 'Affiliation': 'Department of Developmental Psychology, Utrecht University, PO Box 80140, 3508, TC Utrecht, the Netherlands. Electronic address: o.m.laceulle@uu.nl.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karreman', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands. Electronic address: a.karreman@uvt.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Vries', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands; Department of Medical Psychology, Elisabeth-Tweesteden Hospital, Tilburg, Postbus 90151, 5000, LC Tilburg, the Netherlands. Electronic address: j.devries@uvt.nl.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Department of Medical and Clinical Psychology, Centre of Research on Psychology in Somatic Diseases, Tilburg University, Postbus 90153, 5000 LE Tilburg, the Netherlands; Department of Anxiety and Obsessive Compulsive Disorders, PsyQ, Lijnbaan 4, 2512, VA, The Hague, the Netherlands. Electronic address: c.w.korrelboom@uvt.nl.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101616']
2985,33253973,Cognitive function following pulmonary rehabilitation and post-discharge recovery from exacerbation in people with COPD.,"BACKGROUND
Cognitive impairment (CI) is prevalent in COPD and is associated with poor health-related quality of life. Recovery of cognition following an acute exacerbation of COPD (AECOPD), the impact of CI on pulmonary rehabilitation (PR) uptake and the effect of PR on CI are not fully understood.
METHODS
This 6-week prospective study analysed 67 people with stable COPD symptoms who completed PR (PR group) and the recovery of 45 people admitted for AECOPD (AECOPD group). All participants were assessed for cognitive function (Montreal Cognitive Assessment [MoCA]), health status (COPD Assessment Test, Chronic Respiratory Questionnaire), lower extremity function (Short Physical Performance Battery), and psychological well-being (Hospital Anxiety and Depression Score). Follow up assessments were carried out after a 6-week recovery post-discharge in AECOPD group and after PR in the PR group.
RESULTS
AECOPD group showed no improvement in MoCA following a 6-week recovery post-discharge (Δ-0.8 ± 3.2, p = 0.205), despite improvements in all other clinical outcomes. PR uptake among the AECOPD group was not associated with the presence of CI (p = 0.325). Participants in the PR group with CI at baseline showed a significant improvement in MoCA score following PR (Δ1.6 ± 2.4, p = 0.004).
CONCLUSIONS
Cognition does not improve following 6-week recovery post-AECOPD, and CI may influence patients' response to PR referral as an inpatient. PR improves cognition in people with stable COPD symptoms and CI. People with AECOPD should be actively encouraged to attend PR irrespective of mild-moderate cognition but may require additional support or opportunities to take part.",2020,PR uptake among the AECOPD group was not associated with the presence of CI (p = 0.325).,"['people with COPD', 'people with stable COPD symptoms and CI', '67 people with stable COPD symptoms who completed PR (PR group) and the recovery of 45 people admitted for AECOPD (AECOPD group']",['AECOPD'],"['MoCA score', 'Cognitive function', 'MoCA', 'PR uptake', 'pulmonary rehabilitation (PR) uptake', 'cognitive function (Montreal Cognitive Assessment [MoCA]), health status (COPD Assessment Test, Chronic Respiratory Questionnaire), lower extremity function (Short Physical Performance Battery), and psychological well-being (Hospital Anxiety and Depression Score', 'PR improves cognition']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",67.0,0.0571883,PR uptake among the AECOPD group was not associated with the presence of CI (p = 0.325).,"[{'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'France', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address: Grace.France@uhl-tr.nhs.uk.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Orme', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: mwo4@leicester.ac.uk.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Greening', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: neil.greening@leicester.ac.uk.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Steiner', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: ms346@leicester.ac.uk.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Chaplin', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address: emma.chaplin@uhl-tr.nhs.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Clinch', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK. Electronic address: lisa.clinch@uhl-tr.nhs.uk.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust, Leicester, UK; Department of Respiratory Sciences, University of Leicester, Leicester, UK. Electronic address: sally.singh@uhl-tr.nhs.uk.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106249']
2986,33253953,Neurologic factors in patients with vascular mild cognitive impairment based on fMRI.,"The study drew attention to the application of functional magnetic resonance imaging (fMRI) and neuro-psychology in diagnosis of vascular mild cognitive impairment and the exploration of its relevant factors. Specifically, 28 patients with vascular cognitive impairment (VCI) were rolled inro an observation group, and 30 normal people were rolled into a control group. They all accepted MRI examination. The automatic segmentation algorithm based on graph theory was adopted to process the image. The age, gender, disease course, Montreal cognitive assessment (MoCA) score, regional homogeneity (ReHo), and low frequency amplitude (ALFF) levels were recorded. The results showed that there were no significant differences in age, gender, and course of disease between the observation group and the control group (P>0.05). The level of ReHo in the left posterior cerebellum of the observation group was significantly higher than that of the control group (P<0.05).The ReHo level of bilateral cingulate cortex was negatively correlated with MOCA score (P<0.05). The ALFF of bilateral inferior parietal lobe, parietal lobe, and prefrontal lobe in the observation group was significantly lower than that in the control group, and the ALFF of bilateral anterior cingulate gyrus, superior medial frontal gyrus, orbital frontal gyrus, right middle frontal gyrus, and right auxiliary motor area was higher than that in the control group (P<0.05) .Heart diseases such as myocardial infarction and atrial fibrillation are high risk factors for VCI. All in all, the fMRI combined with automatic segmentation algorithm can non-invasively observe the changes of the patient's brain tissue, which can be used in the recognition of VCI. The global network attributes of patients with depression tend to be more randomized and have stronger resilience under targeted attacks.",2020,The level of ReHo in the left posterior cerebellum of the observation group was significantly higher than that of the control group (P<0.05).The ReHo level of bilateral cingulate cortex was negatively correlated with MOCA score (P<0.05).,"['28 patients with vascular cognitive impairment (VCI) were rolled inro an observation group, and 30 normal people were rolled into a control group', 'patients with depression', 'patients with vascular mild cognitive impairment based on fMRI']","['functional magnetic resonance imaging (fMRI) and neuro-psychology', 'fMRI combined with automatic segmentation algorithm']","['ALFF of bilateral anterior cingulate gyrus, superior medial frontal gyrus, orbital frontal gyrus, right middle frontal gyrus, and right auxiliary motor area', 'level of ReHo in the left posterior cerebellum', 'disease course, Montreal cognitive assessment (MoCA) score, regional homogeneity (ReHo), and low frequency amplitude (ALFF) levels', 'MOCA score', 'ALFF of bilateral inferior parietal lobe, parietal lobe, and prefrontal lobe', 'Neurologic factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3805043', 'cui_str': 'Vascular cognitive impairment'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0441635', 'cui_str': 'Segment'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0018427', 'cui_str': 'Structure of cingulate gyrus'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0152297', 'cui_str': 'Structure of middle frontal gyrus'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0228195', 'cui_str': 'Structure of frontal lobe gyrus'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0007765', 'cui_str': 'Cerebellar structure'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}]",28.0,0.0299923,The level of ReHo in the left posterior cerebellum of the observation group was significantly higher than that of the control group (P<0.05).The ReHo level of bilateral cingulate cortex was negatively correlated with MOCA score (P<0.05).,"[{'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Zhuang', 'Affiliation': ""Department of Medical Imaging, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian City, 223300, Jiangsu Province, China.""}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""Department of Digestive, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian City, 223300, Jiangsu Province, China.""}, {'ForeName': 'Jiandong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Imaging, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian City, 223300, Jiangsu Province, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': ""Department of Medical Imaging, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian City, 223300, Jiangsu Province, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Medical Imaging, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian City, 223300, Jiangsu Province, China.""}, {'ForeName': 'Genji', 'Initials': 'G', 'LastName': 'Bo', 'Affiliation': ""Department of Medical Imaging, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian City, 223300, Jiangsu Province, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Medical Imaging, The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huaian City, 223300, Jiangsu Province, China. Electronic address: fengyun8703@yeah.net.""}]",World neurosurgery,['10.1016/j.wneu.2020.11.120']
2987,33253910,Safety and feasibility of mesenchymal stem cell therapy in patients with aqueous deficient dry eye disease.,"PURPOSE
To evaluate the safety and feasibility of injecting allogeneic adipose-derived mesenchymal stem cells (ASCs) into the lacrimal gland (LG) as a treatment of aqueous deficient dry eye disease (ADDE).
METHODS
In this open-label, 5-visit clinical trial (baseline, treatment and weeks 1, 4 and 16) seven subjects with ADDE received one transconjunctival injection of allogeneic ASCs into the LG in one eye. The ASC product contained 22 million ASCs/ml and the injected volume was maximally 50% of the LG volume as determined on magnetic resonance imaging (MRI). Treatment related adverse events (AEs) were assessed at each visit (primary endpoint). Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint.
RESULTS
No AEs related to the study treatment were observed. Mean follow-up time was 126 days after treatment. The mean OSDI score decreased from 58.9 ± 20.6 at baseline to 34.1 ± 21.6 (p < 0.002). In the study eye mean tear osmolarity decreased from 312.9 ± 10.4 to 291.6 ± 10.9 mosm/l (p < 0.002), mean TBUT increased from 3.7 ± 1.5 to 7.1 ± 1.9 s (p < 0.002), mean Schirmer's I test increased from 4.6 ± 0.7 to 8.1 ± 3.1 mm/5 min (p < 0.03), while mean Oxford grade showed a trend towards a decrease from 2.4 ± 0.7 to 1.3 ± 1 (p < 0.10).
CONCLUSION
Our trial suggests that injection of allogeneic ASCs into the LG is a safe and feasible treatment of severe ADDE. A randomized placebo-controlled trial aimed at elucidating the therapeutic effect of allogeneic ASCs in a larger patient cohort from our research group is currently underway.",2020,"Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint.
","['patients with aqueous deficient dry eye disease', 'aqueous deficient dry eye disease (ADDE']","['placebo', 'allogeneic adipose-derived mesenchymal stem cells (ASCs', 'mesenchymal stem cell therapy', 'transconjunctival injection of allogeneic ASCs', 'allogeneic ASCs']","['mean TBUT', ""Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test"", 'mean OSDI score', 'mean tear osmolarity', 'adverse events (AEs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704950', 'cui_str': 'Mesenchymal Stem Cells, Adipose-Derived'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0442347', 'cui_str': 'Transconjunctival approach'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",7.0,0.0464932,"Ocular Surface Disease Index (OSDI), tear osmolarity, tear film breakup time (TBUT), corneal staining (Oxford grade) and Schirmer's I test were assessed at each timepoint.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Møller-Hansen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark. Electronic address: michael.moeller-hansen@regionh.dk.'}, {'ForeName': 'Ann-Cathrine', 'Initials': 'AC', 'LastName': 'Larsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}, {'ForeName': 'Peter Bjerre', 'Initials': 'PB', 'LastName': 'Toft', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}, {'ForeName': 'Charlotte Duch', 'Initials': 'CD', 'LastName': 'Lynggaard', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Diagnostic Radiology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Bruunsgaard', 'Affiliation': 'Department of Clinical Immunology, Rigshospitalet, And Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Haack-Sørensen', 'Affiliation': 'Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ekblond', 'Affiliation': 'Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Heegaard', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet-Glostrup, University of Copenhagen, Denmark.'}]",The ocular surface,['10.1016/j.jtos.2020.11.013']
2988,33253864,Association of Miltefosine with Granulocyte and Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Cutaneous Leishmaniasis in the Amazon Region: a randomized and controlled trial.,"OBJECTIVES
To compare topical GM-CSF and miltefosine (G + M) versus placebo and miltefosine (P + M) or parenteral meglumine antimoniate (MA) in the treatment of 150 patients with cutaneous leishmaniasis (CL) caused by Leishmania guyanensis in the Amazon.
DESIGN
A randomized and double-blinded clinical trial.
RESULTS
At 90 days after initiation of therapy the cure rates were 66%, 58% and 52% for the groups P + M, G + M, and MA respectively (p > 0.05). Cure rates at 180 days did not differ. Healing time was similar in the 3 groups, but faster in the MA group compared to the G + M group (p = 0.04). Mild and transitory systemic adverse events were frequent in all groups (above 85%). Nausea (85%) and vomiting (39%) predominated in the miltefosine groups; arthralgia (51%) and myalgia (48%) in the MA group. One patient (group MA) stopped treatment after presenting fever, exanthema, and severe arthralgia.
CONCLUSIONS
Miltefosine did not present a higher cure rate than MA, and the association of GM-CSF did not improve the therapeutic response. Nevertheless, due to its less toxicity, easier administration, and a similar cure rate when compared with MA, miltefosine should remain as one of the main drugs for treating CL due to L. guyanensis. (Clinicaltrials.gov Identifier NCT03023111).",2020,"At 90 days after initiation of therapy the cure rates were 66%, 58% and 52% for the groups P + M, G + M, and MA respectively (p > 0.05).","['Cutaneous Leishmaniasis in the Amazon Region', '150 patients with cutaneous leishmaniasis (CL) caused by Leishmania guyanensis in the Amazon']","['placebo and miltefosine (P\u2009+\u2009M', 'topical GM-CSF and miltefosine (G\u2009+\u2009M', 'Miltefosine with Granulocyte and Macrophage Colony Stimulating Factor (GM-CSF', 'Miltefosine', 'parenteral meglumine antimoniate (MA']","['myalgia', 'vomiting', 'therapeutic response', 'Nausea', 'Mild and transitory systemic adverse events', 'cure rate', 'arthralgia', 'Cure rates', 'Healing time', 'cure rates']","[{'cui': 'C0023283', 'cui_str': 'Cutaneous leishmaniasis'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0086535', 'cui_str': 'Leishmania guyanensis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0068006', 'cui_str': 'miltefosine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C1096768', 'cui_str': 'meglumine antimoniate'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",150.0,0.061479,"At 90 days after initiation of therapy the cure rates were 66%, 58% and 52% for the groups P + M, G + M, and MA respectively (p > 0.05).","[{'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Mendes', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil; Universidade Federal do Amazonas, Brazil.'}, {'ForeName': 'Jorge Oliveira', 'Initials': 'JO', 'LastName': 'Guerra', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Bleno', 'Initials': 'B', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Amazonas, Brazil.'}, {'ForeName': 'Aríneia Soares da', 'Initials': 'ASD', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Maria das', 'Initials': 'MD', 'LastName': 'Graças Barbosa Guerra', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Ortiz', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Susan Smith', 'Initials': 'SS', 'LastName': 'Doria', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil.'}, {'ForeName': 'George Villarouco da', 'Initials': 'GVD', 'LastName': 'Silva', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Denison Vital', 'Initials': 'DV', 'LastName': 'de Jesus', 'Affiliation': 'Programa de Pós graduação em Medicina Tropical da Universidade do Estado do Amazonas/Fundação de Medicina Tropical Dr. Heitor Vieira Dourado-UEA/FMTHVD, Manaus, Amazonas, Brazil.'}, {'ForeName': 'Manoel', 'Initials': 'M', 'LastName': 'Barral-Netto', 'Affiliation': 'Instituto Gonçalo Moniz (IGM), FIOCRUZ, Bahia, Brazil.'}, {'ForeName': 'Gerson', 'Initials': 'G', 'LastName': 'Penna', 'Affiliation': 'Núcleo de Medicina Tropical, Universidade de Brasília (UnB), Brasília-DF, e Escola Fiocruz de Governo, Fundação Oswaldo Cruz Brasília, Brazil.'}, {'ForeName': 'Edgar M', 'Initials': 'EM', 'LastName': 'Carvalho', 'Affiliation': 'Instituto Gonçalo Moniz (IGM), FIOCRUZ, Bahia, Brazil; Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil; Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais (INCT-DT), Ministério da Ciência, Tecnologia, Inovações e Comunicações, CNPq, Brasília, DF, Brazil.'}, {'ForeName': 'Paulo R L', 'Initials': 'PRL', 'LastName': 'Machado', 'Affiliation': 'Instituto Gonçalo Moniz (IGM), FIOCRUZ, Bahia, Brazil; Serviço de Imunologia, Hospital Universitário Prof. Edgard Santos, Universidade Federal da Bahia, Salvador, Bahia, Brazil; Instituto Nacional de Ciência e Tecnologia em Doenças Tropicais (INCT-DT), Ministério da Ciência, Tecnologia, Inovações e Comunicações, CNPq, Brasília, DF, Brazil. Electronic address: 19pmachado@gmail.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.11.183']
2989,33253833,Long-term efficacy and safety of ixekizumab: 5-year analysis of the UNCOVER-3 randomized controlled trial.,"OBJECTIVE
To report efficacy and safety of the approved IXE dose over 5 years from UNCOVER-3. (NCT01646177).
METHODS
Patients (N=1346) were randomized 1:2:2:2 to receive subcutaneous injections of placebo, etanercept 50 mg twice weekly, IXE 80 mg every 2 weeks (Q2W) or every 4 weeks (Q4W) following an initial dose of IXE 160 mg. At Week 12, patients entered the long-term extension (LTE) period with IXEQ4W dosing and could escalate to Q2W after Week 60. Efficacy was reported for the IXEQ2W/Q4W group of the intent-to-treat population. Safety was reported for patients who received at least 1 dose of IXEQ2W/Q4W.
RESULTS
Using modified nonresponder imputation, 78.8%/67.1%/46.2% of patients receiving the approved dose of IXE Q2W/Q4W (N=385) achieved ≥75%, ≥90%, or 100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 264, respectively; static Physician's Global Assessment (sPGA) score of (0/1) and sPGA (0) responses were 69.2% and 45.3%, respectively. Infections were the most observed treatment-emergent adverse event (72.7% of patients).
LIMITATIONS
Lack of comparison treatment group after Week 12.
CONCLUSION
IXE demonstrates sustained efficacy and consistent safety through 264 weeks in patients using the approved dose.",2020,"Infections were the most observed treatment-emergent adverse event (72.7% of patients).
",['Patients (N=1346'],"['ixekizumab', 'subcutaneous injections of placebo, etanercept 50 mg twice weekly, IXE', 'IXE Q2W/Q4W', 'IXE']","['Psoriasis Area and Severity Index (PASI', 'Efficacy', 'Safety', ""static Physician's Global Assessment (sPGA) score of (0/1) and sPGA (0) responses""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",1346.0,0.23946,"Infections were the most observed treatment-emergent adverse event (72.7% of patients).
","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, USA. Electronic address: ablauvelt@oregonmedicalresearch.com.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Mabuchi', 'Affiliation': 'Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Leung', 'Affiliation': 'Syneos Health, Morrisville, NC, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Garrelts', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Crane', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'ElMaraghy', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Patel', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Ridenour', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Kyoungah', 'Initials': 'K', 'LastName': 'See', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Carle', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Toulouse University and Larrey Hospital, Toulouse, France.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.11.022']
2990,33253816,Effect of Intermittent High Mechanical Index Impulses on Left Ventricular Strain.,"BACKGROUND
Intermittent high mechanical index (MI) impulses from a transthoracic ultrasound transducer are recommended for regional wall motion (RWM) analysis and assessment of myocardial perfusion following an intravenous administration of ultrasound enhancing agents (UEAs). High MI impulses (>1.0) applied in this setting have also been shown to increase microvascular blood flow via a purinergic signaling pathway, but their effects on left ventricular (LV) myocardial function are unknown. Therefore, we investigated the effect of transthoracic intermittent high MI (IH MI) impulses during an intravenous UEA infusion in patients with normal and abnormal resting systolic function.
METHODS
Fifty patients referred for echocardiography to evaluate LV systolic function during a continuous infusion of UEAs (Definity 3% infusion), were prospectively assigned to: Group 1: low MI (<0.2) imaging alone; or Group 2: low MI (<0.2) imaging with IH MI impulses (five frames; 1.8 MHz, 1.0-1.1 MI) applied at least two times in each apical window to clear myocardial contrast. Global (GLS) strain measurements were obtained at baseline prior to UEA administration and at five minute intervals up to 10 minutes after infusion completion.
RESULTS
There were no differences between groups with respect to age, gender, resting GLS, biplane left ventricular ejection fraction (LVEF), or cardiac risk factors. Resting GLS in group 1 was -15.5 + 5.2% before to -15.5 + 5.4% at 10 minutes after UEA infusion. In comparison, GLS increased in Group II (-15.3+5.0 before and -16.8 + 4.8 % at 10 minutes; p<0.00001). Improvements in GLS were seen in patients with normal and abnormal systolic function. Regional analysis demonstrated the increase in strain in the abnormal LVEF patients was primarily in the apical segments (-12.0+2.7% before to -13.4+3.4% at 10 minutes after IH MI; p=0.001).
CONCLUSIONS
High mechanical index impulses during a commercially available contrast infusion can improve left ventricular systolic function, and may have therapeutic effect in patients with left ventricular dysfunction.",2020,"There were no differences between groups with respect to age, gender, resting GLS, biplane left ventricular ejection fraction (LVEF), or cardiac risk factors.","['patients with normal and abnormal systolic function', 'patients with normal and abnormal resting systolic function', 'Fifty patients referred for echocardiography to evaluate LV systolic function during a continuous infusion of UEAs (Definity 3% infusion', 'patients with left ventricular dysfunction']","['transthoracic intermittent high MI (IH MI', 'Intermittent High Mechanical Index Impulses', 'low MI (<0.2) imaging alone; or Group 2: low MI (<0.2) imaging with IH MI impulses', 'ultrasound enhancing agents (UEAs']","['biplane left ventricular ejection fraction (LVEF), or cardiac risk factors', 'left ventricular systolic function', 'strain', 'GLS', 'Global (GLS) strain measurements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0963149', 'cui_str': 'Definity'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",50.0,0.0258494,"There were no differences between groups with respect to age, gender, resting GLS, biplane left ventricular ejection fraction (LVEF), or cardiac risk factors.","[{'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Albulushi', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, University of Nebraska Medical Center Omaha, Nebraska.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Olson', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, University of Nebraska Medical Center Omaha, Nebraska.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, University of Nebraska Medical Center Omaha, Nebraska.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, University of Nebraska Medical Center Omaha, Nebraska.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Mathers', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, University of Nebraska Medical Center Omaha, Nebraska.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Aboeata', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, University of Nebraska Medical Center Omaha, Nebraska.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Porter', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE, University of Nebraska Medical Center Omaha, Nebraska. Electronic address: trporter@unmc.edu.'}]",Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography,['10.1016/j.echo.2020.11.013']
2991,33253776,"LP2, the first lanthipeptide GPCR agonist in a human pharmacokinetics and safety study.","Introduction of a lanthionine into a peptide may enhance target affinity, target specificity and proteolytic resistance. This manuscript reports preclinical safety studies and the first-in-human study with the lanthipeptide AT 2 R agonist LP2, a structural analog of cAng-(1-7), whose N-terminus was protected against aminopeptidases by the presence of a D-lysine. None of the preclinical studies, including an in vitro multitarget panel, behavioral, respiratory and cardiovascular measurements, genotoxicity and toxicity studies in rat and dog, posed any safety concern. Due to lack of toxicity the maximum tolerated dose was not reached neither in rat nor in dog. In the human dose escalation study, healthy male volunteers received a single 1 mL subcutaneous injection (0.001 mg, 0.01 mg or 0.1 mg) of LP2 or matching placebo. In contrast to angiotensin II which has a T1/2 in plasma of < 1 minute, LP2 has a T1/2 of approximately 2.1-2.6 hours. The fraction of the dose excreted unchanged in urine ranged from 84.73 ± 10.4% at a dose of 0.001 mg to 66.4 ± 3.9% at 0.1 mg. There were no deaths, serious adverse events or subject withdrawals as a result of an adverse event. The incidence of adverse events was 16.7 %; each was mild in severity. One adverse event, peripheral coldness, was considered to be possibly related to LP2 at 0.001 mg LP2. None of the results was considered to pose a clinically relevant safety concern. This study supports the potential for the therapeutic use of lanthipeptides.",2020,"There were no deaths, serious adverse events or subject withdrawals as a result of an adverse event.",['healthy male volunteers'],"['single 1\u2009mL subcutaneous injection', 'LP2 or matching placebo']","['incidence of adverse events', 'deaths, serious adverse events']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.0523441,"There were no deaths, serious adverse events or subject withdrawals as a result of an adverse event.","[{'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Namsolleck', 'Affiliation': 'Lanthio Pharma, 9727 DL Groningen, the Netherlands. Electronic address: namsolleck@lanthiopharma.com.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Richardson', 'Affiliation': 'AR Pharma Projects Ltd., Westside Cottage, Highfield Park, Marlow, SL7 2DE, UK. Electronic address: alan@arpp.biz.'}, {'ForeName': 'Gert N', 'Initials': 'GN', 'LastName': 'Moll', 'Affiliation': 'Lanthio Pharma, 9727 DL Groningen, the Netherlands; Department of Molecular Genetics, Groningen Biomolecular Sciences and Biotechnology Institute, University of Groningen, 9747 AG Groningen, the Netherlands. Electronic address: g.n.moll@rug.nl.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Mescheder', 'Affiliation': 'Lanthio Pharma, 9727 DL Groningen, the Netherlands. Electronic address: axel.mescheder@cristaltherapeutics.com.'}]",Peptides,['10.1016/j.peptides.2020.170468']
2992,33253756,"The Utility of Routine Fundus Photography Screening for Posterior Segment Disease: A Stepped-wedge, Cluster-randomized Trial in South India.","PURPOSE
To assess whether routine fundus photography (RFP) to screen for posterior segment disease at community eye clinics in South India increases referral to the urban hospital for ophthalmology care.
DESIGN
Stepped-wedge, cluster-randomized trial.
PARTICIPANTS
Patients aged 40-75 and those aged 20-40 with a known history of hypertension or diabetes mellitus presenting to four technician-run, community eye care centers (vision centers) associated with the Aravind Eye Hospital, Pondicherry, India.
METHODS
Vision centers (clusters) were randomized to standard care or RFP across five 2-week study periods (steps). Patients in each cluster received standard care in the first step. At the start of each subsequent step, a randomly chosen cluster crossed over to providing RFP to eligible patients. Patients in all clusters took part in RFP during the last step. Standard care involved technician eye exams, optional fundus photography, and teleconsultation with an ophthalmologist. RFP involved technician eye exams, mandatory dilation and 40-degree fundus photography, and teleconsultation with an ophthalmologist.
MAIN OUTCOME MEASURES
Standard care and RFP clusters were compared by the proportion of patients referred for in-person evaluation by an ophthalmologist due to fundus photography findings as well as urgency of referral (urgently in ≤2 weeks vs. non-urgently in >2 weeks). Generalized linear mixed models adjusting for cluster and step were used to estimate the odds of referral due to fundus photography findings compared to standard care.
RESULTS
1447 patients were enrolled across the vision centers, including 737 in the standard care group and 710 in the RFP group. Compared to standard care, the RFP group had a higher proportion of referrals due to fundus photography findings (11.3% vs. 4.4%), non-urgent referrals due to fundus photography (9.3% vs. 3.3%), and urgent referrals due to fundus photography (1.8% vs. 1.1%). The RFP intervention was associated with a two-fold increased odds of being referred due to photography findings compared to standard care (odds ratio=2.07, 95% confidence interval=0.98-4.40, p=0.058).
CONCLUSION
Adding RFP to community eye clinics was associated with an increased odds of referral compared to standard care. This increase in referral was mostly attributed to non-urgent posterior segment disease.",2020,"The RFP intervention was associated with a two-fold increased odds of being referred due to photography findings compared to standard care (odds ratio=2.07, 95% confidence interval=0.98-4.40, p=0.058).
","['1447 patients were enrolled across the vision centers, including 737 in the standard care group and 710 in the RFP group', 'Posterior Segment Disease', 'Vision centers (clusters', 'posterior segment disease at community eye clinics in South India increases referral to the urban hospital for ophthalmology care', 'Patients aged 40-75 and those aged 20-40 with a known history of hypertension or diabetes mellitus presenting to four technician-run, community eye care centers (vision centers) associated with the Aravind Eye Hospital, Pondicherry, India']","['standard care or RFP', 'routine fundus photography (RFP', 'Routine Fundus Photography Screening']","['urgency of referral', 'RFP involved technician eye exams, mandatory dilation and 40-degree fundus photography, and teleconsultation with an ophthalmologist', 'proportion of referrals due to fundus photography findings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4520473', 'cui_str': 'Vision center'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C0348015', 'cui_str': 'Posterior segment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0200189', 'cui_str': 'Ocular fundus photography'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282675', 'cui_str': 'Teleconsultation'}, {'cui': 'C1704292', 'cui_str': 'Ophthalmologist'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}]",1447.0,0.0381449,"The RFP intervention was associated with a two-fold increased odds of being referred due to photography findings compared to standard care (odds ratio=2.07, 95% confidence interval=0.98-4.40, p=0.058).
","[{'ForeName': 'Nakul S', 'Initials': 'NS', 'LastName': 'Shekhawat', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, MI, USA; Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Niziol', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sankalp S', 'Initials': 'SS', 'LastName': 'Sharma', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}, {'ForeName': 'Sanil', 'Initials': 'S', 'LastName': 'Joseph', 'Affiliation': 'Lions Aravind Institute of Community Ophthalmology, Madurai, Tamil Nadu, India.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Robin', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Gillespie', 'Affiliation': 'Department of Epidemiology, University of Michigan, Ann Arbor, MI, USA; Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Musch', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, MI, USA; Department of Epidemiology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Woodward', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, MI, USA. Electronic address: mariawoo@med.umich.edu.'}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': 'Aravind Eye Hospital, Pondicherry, India.'}]",Ophthalmology,['10.1016/j.ophtha.2020.11.025']
2993,33253691,Automatic coding of environmental distance for walking-related locomotion in the foot-related sensory-motor system: a TMS study on macro-affordances.,"We have recently described a facilitation effect for the execution of a walking-related action in response to distant objects/locations in the extrapersonal space. Based on the parallelism with the well-known effect of ""micro-affordance"", observed during the execution of functionally appropriate hand-related actions towards manipulable objects, we have referred to this effect in terms of ""macro-affordance"". Here we used transcranical magnetic stimulation (TMS) to investigate whether a foot-related region located in the human dorsal precuneate cortex plays a causal role in the generation and maintenance of such behavioral effect. This question was addressed by comparing the magnitude of the facilitation effect during an incidental go/no-go task, i.e. advantage for walking-related actions to pictures framing an environment from a far vs. near distance, during three different TMS conditions. The three TMS conditions were collected in all subjects in a randomized order and included stimulation of: i. a foot-related region in the anterior precuneus, ii. a control region in the middle intraparietal sulcus (mIPS), and iii. a sham condition. Enrollment in the TMS protocol was based on analysis of individual performance during a preliminary session conducted using a sham stimulation. TMS was administered at a low frequency range before the beginning of each condition. The results showed that stimulation of the foot-related region in the anterior precuneus produced a significant reduction of the walking-related facilitation effect as compared to both stimulation of the active-control region and the non-active sham stimulation. These findings suggest that the foot-related sensory-motor system directly participates in the process of extraction of the spatial features (i.e. distance) from an environmental scene that are useful for locomotion. More in general, these findings support an automatic coding of environmental affordance or ""macro-affordances"" in the walking-related sensory-motor system.",2020,We have recently described a facilitation effect for the execution of a walking-related action in response to distant objects/locations in the extrapersonal space.,[],"['transcranical magnetic stimulation (TMS', 'TMS']",['walking-related facilitation effect'],[],"[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0399037,We have recently described a facilitation effect for the execution of a walking-related action in response to distant objects/locations in the extrapersonal space.,"[{'ForeName': 'Emanuele Cosimo', 'Initials': 'EC', 'LastName': 'Altomare', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, and Institute for Advanced Biomedical Technologies (ITAB), University G. d'Annunzio, Chieti-Pescara, Italy.""}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Committeri', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, and Institute for Advanced Biomedical Technologies (ITAB), University G. d'Annunzio, Chieti-Pescara, Italy.""}, {'ForeName': 'Rosalia', 'Initials': 'R', 'LastName': 'Di Matteo', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, and Institute for Advanced Biomedical Technologies (ITAB), University G. d'Annunzio, Chieti-Pescara, Italy.""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Capotosto', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, and Institute for Advanced Biomedical Technologies (ITAB), University G. d'Annunzio, Chieti-Pescara, Italy.""}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Tosoni', 'Affiliation': ""Department of Neuroscience, Imaging and Clinical Sciences, and Institute for Advanced Biomedical Technologies (ITAB), University G. d'Annunzio, Chieti-Pescara, Italy. Electronic address: atosoni@unich.it.""}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107696']
2994,33253678,Impact of Chronic Total Occlusion and Revascularization Strategy in Patients with Infarct-Related Cardiogenic Shock A Subanalysis of the CULPRIT-SHOCK trial.,"BACKGROUND
The impact of coronary artery chronic total occlusion (CTO) and its management with percutaneous coronary intervention (PCI) in the setting of myocardial infarction (MI) related cardiogenic shock (CS) remains unclear.
METHODS
This is a pre-specified analysis from the The Culprit Lesion Only PCI versus Multivessel PCI in Cardiogenic Shock (CULPRIT-SHOCK) trial which randomized patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy. CTO was defined by central core-laboratory evaluation. The independent associations between the presence of CTO and adverse outcomes at 30 days and one year were assessed using multivariate logistics models.
RESULTS
A non-infarct related CTO was present in 157/667 (23.5%) analyzed patients. Patients presenting with CTO had more frequent diabetes mellitus or prior PCI but less frequently presented with ST segment elevation MI as index event. The presence of CTO was associated with higher rate of death at 30 days (adjusted Odds ratio [aOR] 1.63; 95% confidence interval [CI] 1.01-2.60). Rate of death at one year was also increased but did not reach statistical significance (aOR 1.62; 95%CI 0.99-2.66). Compare to immediate multivessel PCI, a strategy of culprit-lesion-only PCI was associated with lower rates of death or renal replacement therapy at 30 days in patients with and without CTO (OR 0.79 95%CI 0.42-1.49 and OR 0.67 95%CI 0.48-0.96, respectively), without significant interaction (p= 0.68).
CONCLUSION
In patients with MI-related CS and multivessel disease, the presence of CTO is associated with adverse outcomes while a strategy of culprit-lesion-only PCI seems beneficial regardless of the presence of CTO.",2020,Rate of death at one year was also increased but did not reach statistical significance (aOR 1.62; 95%CI 0.99-2.66).,"['Patients with Infarct-Related Cardiogenic Shock', 'patients presenting with MI and multivessel disease complicated by CS to a culprit-lesion-only or immediate multivessel PCI strategy']","['percutaneous coronary intervention (PCI', 'coronary artery chronic total occlusion (CTO']","['rate of death', 'frequent diabetes mellitus or prior PCI', 'rates of death or renal replacement therapy', 'Rate of death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}]",,0.232608,Rate of death at one year was also increased but did not reach statistical significance (aOR 1.62; 95%CI 0.99-2.66).,"[{'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Braik', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie, Pitié Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Guedeney', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie, Pitié Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Behnes', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Barthélémy', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie, Pitié Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Medical Clinic II, University Heart Center Luebeck, Luebeck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Medical Clinic II, University Heart Center Luebeck, Luebeck, Germany.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Rouanet', 'Affiliation': 'Statistician unit, StatEthic, ACTION Study group Levallois-Perret, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hauguel-Moreau', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie, Pitié Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Zeitouni', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie, Pitié Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Overtchouk', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie, Pitié Salpêtrière (AP-HP), Paris, France.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung, Ludwigshafen Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, INSERM UMRS_1166 Institut de cardiologie, Pitié Salpêtrière (AP-HP), Paris, France. Electronic address: gilles.montalescot@aphp.fr.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Akin', 'Affiliation': 'First Department of Medicine-Cardiology, University Medical Centre Mannheim (UMM), University of Heidelberg, Mannheim, Germany.'}]",American heart journal,['10.1016/j.ahj.2020.11.009']
2995,33253664,Retinal Fluid Volatility Associated with Interval Tolerance and Visual Outcomes in Diabetic Macular Edema in the VISTA Phase III Trial.,"PURPOSE
To describe longitudinal retinal fluid dynamics on spectral domain OCT and to identify imaging biomarkers that predict the worsening of DME with interval extension during anti-vascular endothelial growth factor (VEGF) therapy.
DESIGN
A post hoc sub-analysis of phase III, VISTA-DME study.
METHODS
Eyes received either intravitreal aflibercept injection 2 mg every 4 weeks (2q4) or every 8 weeks after 5 initial monthly injections (2q8), and eyes imaged with the Cirrus HD-OCT system were included. The macular cube was analyzed for 10 time-points from baseline through week 100. Retinal OCT images were evaluated using a novel software platform to extract retinal fluid features for calculation of volumetric fluid parameters, including the retinal fluid index (RFI): the percentage of retinal volume that was occupied by intraretinal fluid.
RESULTS
Fifty-five eyes were included in the 2q4 group, and 58 eyes were included in the 2q8 group. Early RFI volatility with a central macular RFI increase by ≥5 points from week 4 to 8 (P = .004, odds ratio [OR] 31.3, 95% confidence interval [CI] 3.0 to 329) and cumulative RFI volatility with an aggregate increase in macular RFI by ≥10 points from those timepoints with increased RFI between baseline to week 20, P = .005, OR 10.2, 95% CI 2.1 to 51.3) were both significant predictors for the worsening of DME and visual acuity when the treatment interval was extended to 8 weeks in the 2q8 group.
CONCLUSIONS
Early fluid dynamics as measured by (1) early RFI volatility and (2) cumulative RFI instability with aggregate increased RFI were associated with intolerance of interval extension.",2020,"Early RFI volatility with a central macular RFI increase by ≥5 points from week 4 to 8 (P = .004, odds ratio [OR] 31.3, 95% confidence interval [CI] 3.0 to 329) and cumulative RFI volatility with an aggregate increase in macular RFI by ≥10 points from those timepoints with increased RFI between baseline to week 20, P = .005, OR 10.2, 95% CI 2.1 to 51.3) were both significant predictors for the worsening of DME and visual acuity when the treatment interval was extended to 8 weeks in the 2q8 group.
","['Fifty-five eyes were included in the 2q4 group, and 58 eyes were included in the 2q8 group']",['intravitreal aflibercept injection'],"['RFI volatility and (2) cumulative RFI instability', 'Early RFI volatility with a central macular RFI increase', 'cumulative RFI volatility', 'worsening of DME and visual acuity', 'macular RFI', 'macular cube']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1959569', 'cui_str': 'Volatility'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0058217', 'cui_str': 'dimethyl ether'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",55.0,0.096759,"Early RFI volatility with a central macular RFI increase by ≥5 points from week 4 to 8 (P = .004, odds ratio [OR] 31.3, 95% confidence interval [CI] 3.0 to 329) and cumulative RFI volatility with an aggregate increase in macular RFI by ≥10 points from those timepoints with increased RFI between baseline to week 20, P = .005, OR 10.2, 95% CI 2.1 to 51.3) were both significant predictors for the worsening of DME and visual acuity when the treatment interval was extended to 8 weeks in the 2q8 group.
","[{'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195; Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195. Electronic address: ehlersj@ccf.org.'}, {'ForeName': 'Atsuro', 'Initials': 'A', 'LastName': 'Uchida', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195; Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195.'}, {'ForeName': 'Duriye Damla', 'Initials': 'DD', 'LastName': 'Sevgi', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195; Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Reed', 'Affiliation': 'Regeneron.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Berliner', 'Affiliation': 'Regeneron.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vitti', 'Affiliation': 'Regeneron.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Regeneron.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195; Cole Eye Institute, Cleveland Clinic, 9500 Euclid Ave/i32, Cleveland, OH 44195.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.11.010']
2996,33253659,Extensive peritoneal lavage with saline after curative gastrectomy for gastric cancer (EXPEL): a multicentre randomised controlled trial.,"BACKGROUND
Peritoneal recurrence of gastric cancer after curative surgical resection is common and portends a poor prognosis. Early studies suggest that extensive intraoperative peritoneal lavage (EIPL) might reduce the risk of peritoneal recurrence and improve survival. We aimed to evaluate the survival benefit of EIPL in patients with gastric cancer undergoing curative gastrectomy.
METHODS
In this open-label, phase 3, multicentre randomised trial, patients aged 21-80 years with cT3 or cT4 gastric cancer undergoing curative resection were enrolled at 22 centres from South Korea, China, Japan, Malaysia, Hong Kong, and Singapore. Patients were randomly assigned to receive surgery and EIPL (EIPL group) or surgery alone (standard surgery group) via a web-based programme in random permuted blocks in varying block sizes of four and six, assuming equal allocation between treatment groups. Randomisation was stratified according to study site and the sequence was generated using a computer program and concealed until the interventions were assigned. After surgery in the EIPL group, peritoneal lavage was done with 1 L of warm (42°C) normal 0·9% saline followed by complete aspiration; this procedure was repeated ten times. The primary endpoint was overall survival. All analyses were done assuming intention to treat. This trial is registered with ClinicalTrials.gov, NCT02140034.
FINDINGS
Between Sept 16, 2012, and Aug 3, 2018, 800 patients were randomly assigned to the EIPL group (n=398) or the standard surgery group (n=402). Two patients in the EIPL group and one in the standard surgery group withdrew from the trial immediately after randomisation and were excluded from the intention-to-treat analysis. At the third interim analysis on Aug 28, 2019, the predictive probability of overall survival being significantly higher in the EIPL group was less than 0·5%; therefore, the trial was terminated on the basis of futility. With a median follow-up of 2·4 years (IQR 1·5-3·0), the two groups were similar in terms of overall survival (hazard ratio 1·09 [95% CI 0·78-1·52; p=0·62). 3-year overall survival was 77·0% (95% CI 71·4-81·6) for the EIPL group and 76·7% (71·0-81·5) for the standard surgery group. 60 adverse events were reported in the EIPL group and 41 were reported in the standard surgery group. The most common adverse events included anastomotic leak (ten [3%] of 346 patients in the EIPL group vs six [2%] of 362 patients in the standard surgery group), bleeding (six [2%] vs six [2%]), intra-abdominal abscess (four [1%] vs five [1%]), superficial wound infection (seven [2%] vs one [<1%]), and abnormal liver function (six [2%] vs one [<1%]). Ten of the reported adverse events (eight in the EIPL group and two in the standard surgery group) resulted in death.
INTERPRETATION
EIPL and surgery did not have a survival benefit compared with surgery alone and is not recommended for patients undergoing curative gastrectomy for gastric cancer.
FUNDING
National Medical Research Council, Singapore.",2020,3-year overall survival was 77·0% (95% CI 71·4-81·6) for the EIPL group and 76·7% (71·0-81·5) for the standard surgery group.,"['Between Sept 16, 2012, and Aug 3, 2018', 'patients undergoing curative gastrectomy for gastric cancer', '800 patients', 'Extensive peritoneal lavage with saline after curative gastrectomy for gastric cancer (EXPEL', 'patients with gastric cancer undergoing curative gastrectomy', 'patients aged 21-80 years with cT3 or cT4 gastric cancer undergoing curative resection were enrolled at 22 centres from South Korea, China, Japan, Malaysia, Hong Kong, and Singapore']","['surgery and EIPL (EIPL group) or surgery alone (standard surgery group) via a web-based programme', 'EIPL', 'extensive intraoperative peritoneal lavage (EIPL', 'standard surgery']","['60 adverse events', 'bleeding', 'abnormal liver function', 'anastomotic leak', 'intra-abdominal abscess', 'risk of peritoneal recurrence and improve survival', 'superficial wound infection', 'adverse events', '3-year overall survival', 'survival benefit', 'death', 'overall survival', 'predictive probability of overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0031148', 'cui_str': 'Peritoneal lavage'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1175872', 'cui_str': 'CAGE1 protein, human'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0031148', 'cui_str': 'Peritoneal lavage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0243001', 'cui_str': 'Abdominal abscess'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",800.0,0.242585,3-year overall survival was 77·0% (95% CI 71·4-81·6) for the EIPL group and 76·7% (71·0-81·5) for the standard surgery group.,"[{'ForeName': 'Han Kwang', 'Initials': 'HK', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jiafu', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': 'Gastrointestinal Cancer Center, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Sang Uk', 'Initials': 'SU', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon, South Korea.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Department of Gastric Surgery, Shizuoka Cancer Centre, Shizuoka, Japan.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Hyung Ho', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Seoul National Bundang Hospital, Seongnam, South Korea.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Law', 'Affiliation': 'Department of Surgery, The University of Hong Kong, Queen Mary Hospital, Hong Kong Special Administrative Region of China.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Shabbir', 'Affiliation': 'Department of Surgery, National University Hospital, Singapore.'}, {'ForeName': 'Kyo Young', 'Initials': 'KY', 'LastName': 'Song', 'Affiliation': ""Department of Surgery, Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Hyung', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Nik Ritza', 'Initials': 'NR', 'LastName': 'Kosai', 'Affiliation': 'Department of Surgery, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Kono', 'Affiliation': 'Department of Gastrointestinal Tract Surgery, Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Kazunari', 'Initials': 'K', 'LastName': 'Misawa', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kinoshita', 'Affiliation': 'Gastric Surgery Division, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Peng Choong', 'Initials': 'PC', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, University Malaya Medical Centre, Kuala Lumpur Malaysia.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, National Cancer Centre, Seoul, South Korea.'}, {'ForeName': 'Jaideep Raj', 'Initials': 'JR', 'LastName': 'Rao', 'Affiliation': 'Department of General Surgery, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Enders', 'Initials': 'E', 'LastName': 'Ng', 'Affiliation': 'Department of Surgery, The Chinese University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Takanobu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Graduate School of Medicine, Gifu University, Gifu, Japan.'}, {'ForeName': 'Do Joong', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Jimmy Bok Yan', 'Initials': 'JBY', 'LastName': 'So', 'Affiliation': 'Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jimmyso@nus.edu.sg.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30315-0']
2997,33253622,Effectiveness of Speech Intervention in Patients With a Cleft Palate: Comparison of Motor-Phonetic Versus Linguistic-Phonological Speech Approaches.,"Purpose The purpose of this study was to compare the effect of two different speech therapy approaches, a traditional motor-phonetic approach and a linguistic-phonological approach, on the speech and health-related quality of life in Dutch-speaking children with a cleft palate with or without a cleft lip (CP ± L) between 4 and 12 years old. Method A block-randomized, sham-controlled design was used. Fourteen children with a CP ± L ( M age = 7.71 years) were divided into two groups using block randomization stratified by age and gender: one receiving motor-phonetic intervention ( n = 7) and one receiving linguistic-phonological intervention ( n = 7). Each group received 10 hr of speech therapy divided over 2 weeks. Perceptual speech assessments were performed on several baseline and posttreatment data points. The psychosocial effects of the intervention were assessed using the patient-reported Velopharyngeal Insufficiency Effects on Life Outcomes questionnaire. Both groups were compared over time using (generalized) linear mixed models. Within-group effects of time were determined using pairwise comparisons with post hoc Bonferroni correction. Results Significant Time × Group interactions with large effect sizes were revealed in terms of consonant proficiency, indicating significant differences in evolution over time among the two groups. Only in the group receiving linguistic-phonological intervention, percentage of correctly produced consonants and places significantly improved after the treatment. Total Velopharyngeal Insufficiency Effects on Life Outcomes scores of the parents significantly improved in both groups after the intervention. Conclusions Both motor-phonetic and linguistic-phonological speech interventions can have a positive impact on the occurrence of cleft speech characteristics and consonant proficiency in children with a CP ± L. A linguistic-phonological approach, however, was observed to be more effective in terms of improving these speech outcomes compared with a motor-phonetic approach. Speech intervention, irrespective of the used approach, significantly improved the participant's health-related quality of life.",2020,"Only in the group receiving linguistic-phonological intervention, percentage of correctly produced consonants and places significantly improved after the treatment.","['children with a CP ± L', 'Fourteen children with a CP ± L ( M age = 7.71 years', 'Dutch-speaking children with a cleft palate with or without a cleft lip (CP ± L) between 4 and 12 years old', 'Patients With a Cleft Palate']","['Speech Intervention', 'motor-phonetic intervention ( n = 7) and one receiving linguistic-phonological intervention', 'Motor-Phonetic Versus Linguistic-Phonological Speech Approaches', 'traditional motor-phonetic approach and a linguistic-phonological approach']","[""participant's health-related quality of life"", 'speech and health-related quality of life', 'Life Outcomes scores', 'Life Outcomes questionnaire']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517861', 'cui_str': '7.71'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0008925', 'cui_str': 'Cleft palate'}, {'cui': 'C0008924', 'cui_str': 'Cleft lip'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031579', 'cui_str': 'Phonetics'}, {'cui': 'C0023741', 'cui_str': 'Linguistics'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",14.0,0.0264964,"Only in the group receiving linguistic-phonological intervention, percentage of correctly produced consonants and places significantly improved after the treatment.","[{'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Alighieri', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Belgium.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Bettens', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bruneel', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Belgium.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': ""D'haeseleer"", 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Belgium.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Van Gaever', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Belgium.'}, {'ForeName': 'Kristiane', 'Initials': 'K', 'LastName': 'Van Lierde', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Belgium.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2020_JSLHR-20-00129']
2998,33253427,"Impact of short-acting vs. standard anaesthetic agents on obstructive sleep apnoea: a randomised, controlled, triple-blind trial.","Sleep apnoea is associated with negative outcomes following general anaesthesia. Current recommendations suggest using short-acting anaesthetic agents in preference to standard agents to reduce this risk, but there is currently no evidence to support this. This randomised controlled triple-blind trial tested the hypothesis that a combination of short-acting agents (desflurane-remifentanil) would reduce the postoperative impact of general anaesthesia on sleep apnoea severity compared with standard agents (sevoflurane-fentanyl). Sixty patients undergoing hip arthroplasty under general anaesthesia were randomised to anaesthesia with desflurane-remifentanil or sevoflurane-fentanyl. Respiratory polygraphy was performed before surgery and on the first and third postoperative nights. The primary outcome was the supine apnoea-hypopnoea index on the first postoperative night. Secondary outcomes were the supine apnoea-hypopnoea index on the third postoperative night, and the oxygen desaturation index on the first and third postoperative nights. Additional outcomes included intravenous morphine equivalent consumption and pain scores on postoperative days 1, 2 and 3. Pre-operative sleep study data were similar between groups. Mean (95%CI) values for the supine apnoea-hypopnoea index on the first postoperative night were 18.9 (12.7-25.0) and 21.4 (14.2-28.7) events.h -1 , respectively, in the short-acting and standard anaesthesia groups (p = 0.64). Corresponding values on the third postoperative night were 28.1 (15.8-40.3) and 38.0 (18.3-57.6) events.h -1 (p = 0.34). Secondary sleep- and pain-related outcomes were generally similar in the two groups. In conclusion, short-acting anaesthetic agents did not reduce the impact of general anaesthesia on sleep apnoea severity compared with standard agents. These data should prompt an update of current recommendations.",2020,"In conclusion, short-acting anaesthetic agents did not reduce the impact of general anaesthesia on sleep apnoea severity compared with standard agents.","['Sixty patients undergoing hip arthroplasty under general anaesthesia', 'obstructive sleep apnoea']","['short-acting agents (desflurane-remifentanil', 'anaesthesia with desflurane-remifentanil or sevoflurane-fentanyl', 'short-acting vs. standard anaesthetic agents', 'standard agents (sevoflurane-fentanyl']","['Sleep apnoea', 'Secondary sleep- and pain-related outcomes', 'supine apnoea-hypopnoea index on the third postoperative night, and the oxygen desaturation index on the first and third postoperative nights', 'intravenous morphine equivalent consumption and pain scores on postoperative days 1, 2 and 3. Pre-operative sleep study data', 'supine apnoea-hypopnoea index on the first postoperative night', 'Mean (95%CI) values for the supine apnoea-hypopnoea index on the first postoperative night', 'sleep apnoea severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}]","[{'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",60.0,0.0687781,"In conclusion, short-acting anaesthetic agents did not reduce the impact of general anaesthesia on sleep apnoea severity compared with standard agents.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Albrecht', 'Affiliation': 'Department of Anaesthesia, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bayon', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hirotsu', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Heinzer', 'Affiliation': 'Center for Investigation and Research in Sleep, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}]",Anaesthesia,['10.1111/anae.15236']
2999,33253391,Beneficial effects of autologous mesenchymal stem cell transplantation in active progressive multiple sclerosis.,"In this study (trial registration: NCT02166021), we aimed to evaluate the optimal way of administration, the safety and the clinical efficacy of mesenchymal stem cell (MSC) transplantation in patients with active and progressive multiple sclerosis. Forty-eight patients (28 males and 20 females) with progressive multiple sclerosis (Expanded Disability Status Scale: 3.0-6.5, mean : 5.6 ± 0.8, mean age: 47.5 ± 12.3) and evidence of either clinical worsening or activity during the previous year, were enrolled (between 2015 and 2018). Patients were randomized into three groups and treated intrathecally (IT) or intravenously (IV) with autologous MSCs (1 × 106/kg) or sham injections. After 6 months, half of the patients from the MSC-IT and MSC-IV groups were retreated with MSCs, and the other half with sham injections. Patients initially assigned to sham treatment were divided into two subgroups and treated with either MSC-IT or MSC-IV. The study duration was 14 months. No serious treatment-related safety issues were detected. Significantly fewer patients experienced treatment failure in the MSC-IT and MSC-IV groups compared with those in the sham-treated group (6.7%, 9.7%, and 41.9%, respectively, P = 0.0003 and P = 0.0008). During the 1-year follow-up, 58.6% and 40.6% of patients treated with MSC-IT and MSC-IV, respectively, exhibited no evidence of disease activity compared with 9.7% in the sham-treated group (P < 0.0001 and P < 0.0048, respectively). MSC-IT transplantation induced additional benefits on the relapse rate, on the monthly changes of the T2 lesion load on MRI, and on the timed 25-foot walking test, 9-hole peg test, optical coherence tomography, functional MRI and cognitive tests. Treatment with MSCs was well-tolerated in progressive multiple sclerosis and induced short-term beneficial effects regarding the primary end points, especially in the patients with active disease. The intrathecal administration was more efficacious than the intravenous in several parameters of the disease. A phase III trial is warranted to confirm these findings.",2020,"Treatment with MSCs was well-tolerated in progressive multiple sclerosis and induced short-term beneficial effects regarding the primary end points, especially in the patients with active disease.","['Forty-eight patients (28 males and 20 females) with progressive multiple sclerosis (Expanded Disability Status Scale: 3.0-6.5', 'mean : 5.6\u2009±\u20090.8, mean age: 47.5\u2009±\u200912.3) and evidence of either clinical worsening or activity during the previous year, were enrolled (between 2015 and 2018', 'patients with active disease', 'active progressive multiple sclerosis', 'patients with active and progressive multiple sclerosis']","['autologous mesenchymal stem cell transplantation', 'MSCs', 'MSC-IT or MSC-IV', 'mesenchymal stem cell (MSC) transplantation', 'MSC-IT transplantation', 'treated intrathecally (IT) or intravenously (IV) with autologous MSCs (1\u2009×\u2009106/kg) or sham injections']","['disease activity', 'timed 25-foot walking test, 9-hole peg test, optical coherence tomography, functional MRI and cognitive tests']","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1257990', 'cui_str': 'Stem Cell Transplantation, Mesenchymal'}, {'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.0257579,"Treatment with MSCs was well-tolerated in progressive multiple sclerosis and induced short-term beneficial effects regarding the primary end points, especially in the patients with active disease.","[{'ForeName': 'Panayiota', 'Initials': 'P', 'LastName': 'Petrou', 'Affiliation': 'Unit of Neuroimmunology and Multiple Sclerosis Center, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Kassis', 'Affiliation': 'Unit of Neuroimmunology and Multiple Sclerosis Center, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Netta', 'Initials': 'N', 'LastName': 'Levin', 'Affiliation': 'Department of Neurology and The Agnes-Ginges Center for Neurogenetics, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Backner', 'Affiliation': 'Department of Neurology and The Agnes-Ginges Center for Neurogenetics, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Benoliel', 'Affiliation': 'Department of Neurology and The Agnes-Ginges Center for Neurogenetics, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Frederike Cosima', 'Initials': 'FC', 'LastName': 'Oertel', 'Affiliation': 'Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scheel', 'Affiliation': 'Experimental and Clinical Research Center, Max Delbrueck Center for Molecular Medicine and Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hallimi', 'Affiliation': 'Unit of Neuroimmunology and Multiple Sclerosis Center, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Yaghmour', 'Affiliation': 'Unit of Neuroimmunology and Multiple Sclerosis Center, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Tamir Ben', 'Initials': 'TB', 'LastName': 'Hur', 'Affiliation': 'Department of Neurology and The Agnes-Ginges Center for Neurogenetics, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Ginzberg', 'Affiliation': 'Unit of Neuroimmunology and Multiple Sclerosis Center, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Yarden', 'Initials': 'Y', 'LastName': 'Levy', 'Affiliation': 'Unit of Neuroimmunology and Multiple Sclerosis Center, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Oded', 'Initials': 'O', 'LastName': 'Abramsky', 'Affiliation': 'Department of Neurology and The Agnes-Ginges Center for Neurogenetics, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Karussis', 'Affiliation': 'Unit of Neuroimmunology and Multiple Sclerosis Center, Hadassah University Hospital, Jerusalem, Ein-Kerem, Israel.'}]",Brain : a journal of neurology,['10.1093/brain/awaa333']
3000,33253354,"BACE inhibition causes rapid, regional, and non-progressive volume reduction in Alzheimer's disease brain.","In the phase 3 EPOCH trial (Clinicaltrials.gov; NCT01739348), treatment with the BACE inhibitor verubecestat failed to improve cognition in patients with mild-to-moderate Alzheimer's disease, but was associated with reduced hippocampal volume after 78 weeks as assessed by MRI. The aims of the present exploratory analyses were to: (i) characterize the effect of verubecestat on brain volume by evaluating the time course of volumetric MRI changes for a variety of brain regions; and (ii) understand the mechanism through which verubecestat might cause hippocampal (and other brain region) volume loss by assessing its relationship to measures of amyloid, neurodegeneration, and cognition. Participants were aged 55-85 years with probable Alzheimer's disease dementia and a Mini Mental State Examination score ≥15 and ≤26. MRIs were obtained at baseline and at Weeks 13, 26, 52 and 78 of treatment. MRIs were segmented using Freesurfer and analysed using a tensor-based morphometry method. PET amyloid data were obtained with 18F-flutemetamol (Vizamyl®) at baseline and Week 78. Standardized uptake value ratios were generated with subcortical white matter as a reference region. Neurofilament light chain in the CSF was assessed as a biomarker of neurodegeneration. Compared with placebo, verubecestat showed increased MRI brain volume loss at Week 13 with no evidence of additional loss through Week 78. The verubecestat-related volumetric MRI loss occurred predominantly in amyloid-rich brain regions. Correlations between amyloid burden at baseline and verubecestat-related volumetric MRI reductions were not significant (r = 0.05 to 0.26, P-values > 0.27). There were no significant differences between verubecestat and placebo in changes from baseline in CSF levels of neurofilament light chain at Week 78 (increases of 7.2 and 14.6 pg/ml for verubecestat versus 19.7 pg/ml for placebo, P-values ≥ 0.1). There was a moderate correlation between volumetric MRI changes and cognitive decline in all groups including placebo at Week 78 (e.g. r = -0.45 to -0.55, P < 0.001 for whole brain), but the correlations were smaller at Week 13 and significant only for the verubecestat groups (e.g. r = -0.15 and -0.11, P < 0.04 for whole brain). Our results suggest that the verubecestat-associated MRI brain volume loss is not due to generalized, progressive neurodegeneration, but may be mediated by specific effects on BACE-related amyloid processes.",2020,"There were no significant differences between verubecestat and placebo in changes from baseline in CSF levels of neurofilament light chain at Week 78 (increases of 7.2 and 14.6 pg/ml for verubecestat versus 19.7 pg/ml for placebo, P-values ≥ 0.1).","[""patients with mild-to-moderate Alzheimer's disease"", ""Participants were aged 55-85 years with probable Alzheimer's disease dementia and a Mini Mental State Examination score ≥15 and ≤26""]",['placebo'],"['volumetric MRI reductions', 'Standardized uptake value ratios', 'CSF levels of neurofilament light chain', 'MRIs', 'MRI brain volume loss', 'volumetric MRI loss', 'volumetric MRI changes and cognitive decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C4028269', 'cui_str': 'Nuclear magnetic resonance imaging brain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}]",,0.146714,"There were no significant differences between verubecestat and placebo in changes from baseline in CSF levels of neurofilament light chain at Week 78 (increases of 7.2 and 14.6 pg/ml for verubecestat versus 19.7 pg/ml for placebo, P-values ≥ 0.1).","[{'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Sur', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kost', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': 'Bioclinica, Newark, CA, USA.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Adamczuk', 'Affiliation': 'Bioclinica, Newark, CA, USA.'}, {'ForeName': 'Nick C', 'Initials': 'NC', 'LastName': 'Fox', 'Affiliation': 'Institute of Neurology and UK Dementia Research Institute, University College London, London, UK.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Cummings', 'Affiliation': 'University of Nevada Las Vegas (UNLV) School of Integrated Health Sciences, Las Vegas, NV, USA.'}, {'ForeName': 'Pierre N', 'Initials': 'PN', 'LastName': 'Tariot', 'Affiliation': ""Banner Alzheimer's Institute, University of Arizona College of Medicine, Phoenix, AZ, USA.""}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Aisen', 'Affiliation': 'University of Southern California, San Diego, CA, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': ""Gerontopole, INSERM U 1027, Alzheimer's Disease Research and Clinical Center, Toulouse University Hospital, Toulouse, France.""}, {'ForeName': 'Tiffini', 'Initials': 'T', 'LastName': 'Voss', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Mahoney', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Mukai', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Kennedy', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lines', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Egan', 'Affiliation': 'Merck and Co., Inc., Kenilworth, NJ, USA.'}]",Brain : a journal of neurology,['10.1093/brain/awaa332']
3001,33253340,Comparisons of Postoperative Complications and Nutritional Status After Proximal Laparoscopic Gastrectomy with Esophagogastrostomy and Double-Tract Reconstruction.,"Background
The purpose of this study was to compare postoperative complications and nutritional status between esophagogastrostomy and double-tract reconstruction in patients who underwent laparoscopic proximal gastrectomy, and assess the advantages of both surgical procedures.
Methods
Between 2010 and 2018, 47 cases underwent proximal gastrectomy with esophagogastrostomy ( n = 23) or double-tract reconstruction ( n = 24) at our institution for the treatment of clinical T1N0 adenocarcinoma located in the upper third of the stomach. Patient clinical characteristics, short-term outcomes, nutrition status, and skeletal muscle index were compared among the two groups.
Results
There was no significant difference between esophagogastrostomy and double-tract reconstruction in terms of operation time, blood loss, and length of postoperative hospital stay. Reflux symptoms and anastomotic stenosis were significantly higher in the esophagogastrostomy group compared with the double-tract reconstruction group ( P < 0.001 and P = 0.004, respectively). There was no significant difference in anastomotic leakage, surgical site infection, and pancreatic fistula. For the nutritional status, the decrease rate of cholinesterase was significantly higher in the esophagogastrostomy group compared with the double-tract reconstruction group at 6 months ( P = 0.008) There was no significant difference in the decrease rate of skeletal muscle mass index at 1 year after surgery.
Conclusion
Compared with esophagogastrostomy, double-tract reconstruction tends to have better short-term nutritional status and postoperative outcomes in terms of preventing the occurrence of gastroesophageal reflux and anastomosis stenosis. These findings suggest that double-tract reconstruction may be a useful method in laparoscopic proximal gastrectomy.",2020,"Reflux symptoms and anastomotic stenosis were significantly higher in the esophagogastrostomy group compared with the double-tract reconstruction group ( P < 0.001 and P = 0.004, respectively).","['patients who underwent', '47 cases underwent', 'Methods\n\n\nBetween 2010 and 2018']","['esophagogastrostomy, double-tract reconstruction', 'esophagogastrostomy and double-tract reconstruction', 'laparoscopic proximal gastrectomy', 'proximal gastrectomy with esophagogastrostomy ( n = 23) or double-tract reconstruction', 'Proximal Laparoscopic Gastrectomy with Esophagogastrostomy and Double-Tract Reconstruction']","['rate of cholinesterase', 'Reflux symptoms and anastomotic stenosis', 'rate of skeletal muscle mass index', 'nutrition status, and skeletal muscle index', 'postoperative complications and nutritional status', 'operation time, blood loss, and length of postoperative hospital stay', 'Postoperative Complications and Nutritional Status', 'anastomotic leakage, surgical site infection, and pancreatic fistula']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0192352', 'cui_str': 'Esophagogastrostomy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C4076626', 'cui_str': 'Laparoscopic proximal gastrectomy'}, {'cui': 'C0399713', 'cui_str': 'Proximal subtotal gastrectomy'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0008429', 'cui_str': 'Cholinesterase'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0919938', 'cui_str': 'Anastomotic stenosis'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic leak'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0030290', 'cui_str': 'Pancreatic fistula'}]",,0.0423149,"Reflux symptoms and anastomotic stenosis were significantly higher in the esophagogastrostomy group compared with the double-tract reconstruction group ( P < 0.001 and P = 0.004, respectively).","[{'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Miyauchi', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Matsunaga', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Shishido', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Miyatani', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Hanaki', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Kihara', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Naruo', 'Initials': 'N', 'LastName': 'Tokuyasu', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Takano', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Teruhisa', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Honjo', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Japanese Red Cross Tottori Hospital, Tottori 680-8517, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'Division of Gastrointestinal and Pediatric Surgery, Department of Surgery, School of Medicine, Faculty of Medicine, Tottori University, Yonago 683-8504, Japan and.'}]",Yonago acta medica,['10.33160/yam.2020.11.019']
3002,33253318,Impact of progressive resistance training on CT quantified muscle and adipose tissue compartments in pancreatic cancer patients.,"OBJECTIVES
Loss of body weight is often seen in pancreatic cancer and also predicts poor prognosis. Thus, maintaining muscle mass is an essential treatment goal. The primary aim was to investigate whether progressive resistance training impacts muscle and adipose tissue compartments. Furthermore, the effect of body composition on overall survival (OS) was investigated.
METHODS
In the randomized SUPPORT-study, 65 patients were assigned to 6-month resistance training (2x/week) or a usual care control group. As secondary endpoint, muscle strength of the upper and lower extremities was assessed before and after the intervention period. Routine CT scans were assessed on lumbar L3/4 level for quantification of total-fat-area, visceral-fat-area, subcutaneous-fat-area, intramuscular-fat-area, visceral-to-subcutaneous fat ratio (VFR), muscle-area (MA), muscle-density and skeletal-muscle-index (SMI). OS data were retrieved.
RESULTS
Of 65 patients, 53 had suitable CT scans at baseline and 28 completed the intervention period with suitable CT scans. There were no significant effects observed of resistance training on body composition (p>0.05; effect sizes ω2p <0.02). Significant moderate to high correlations were found between MA and muscle strength parameters (r = 0.57-0.85; p<0.001). High VFR at baseline was a predictor of poor OS (VFR≥1.3 vs. <1.3; median OS 14.6 vs. 45.3 months; p = 0.012). Loss of muscle mass was also a predictor of poor OS (loss vs. gain of SMI; median OS 24.6 vs. 50.8 months; p = 0.049).
CONCLUSION
There is anabolic potential in patients with resectable pancreatic cancer. A progressive resistance training may help patients to maintain their muscle mass and avoid muscle depletion. CT-quantified muscle mass at the level of L3/4 showed a good correlation to muscle strength. Therefore, maintaining muscle mass and muscle strength through structured resistance training could help patients to maintain their physical functioning. A high VFR at baseline and a high loss of muscle mass are predictors of poor OS. Registered on ClinicalTrials.gov (NCT01977066).",2020,There were no significant effects observed of resistance training on body composition (p>0.05; effect sizes ω2p <0.02).,"['patients with resectable pancreatic cancer', 'pancreatic cancer patients', '65 patients']","['resistance training (2x/week) or a usual care control group', 'progressive resistance training']","['lumbar L3/4 level for quantification of total-fat-area, visceral-fat-area, subcutaneous-fat-area, intramuscular-fat-area, visceral-to-subcutaneous fat ratio (VFR), muscle-area (MA), muscle-density and skeletal-muscle-index (SMI', 'overall survival (OS', 'resistance training on body composition', 'muscle strength of the upper and lower extremities', 'MA and muscle strength parameters', 'Loss of muscle mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0854778', 'cui_str': 'Pancreatic carcinoma resectable'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",65.0,0.018283,There were no significant effects observed of resistance training on body composition (p>0.05; effect sizes ω2p <0.02).,"[{'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Wochner', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Clauss', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center and National Center for Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Nattenmüller', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute for Medical Biometry and Computer Science, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Wiskemann', 'Affiliation': 'Division of Medical Oncology, National Center for Tumor Diseases and Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steindorf', 'Affiliation': 'Division of Physical Activity, Prevention and Cancer, German Cancer Research Center and National Center for Tumor Diseases, Heidelberg, Germany.'}]",PloS one,['10.1371/journal.pone.0242785']
3003,33253306,"Postoperative clinical outcomes and inflammatory markers after inguinal hernia repair using local, spinal, or general anesthesia: A randomized controlled trial.","BACKGROUND
No consensus has yet been reached regarding the best anesthetic technique for inguinal hernia repair. This study aimed to compare postoperative clinical outcomes and inflammatory markers among patients who were anesthetized using local, spinal, or general anesthesia for inguinal hernia repair.
METHODS
This randomized controlled trial included patients scheduled to undergo elective unilateral inguinal hernioplasty at Siriraj Hospital during November 2014 to September 2015 study period. Patients were randomly assigned to the local (LA), spinal (SA), or general (GA) anesthesia groups. Primary outcomes were postoperative pain at rest and on mobilization at 8 and 24 hours after surgery.
RESULTS
Fifty-four patients were included, with 18 patients randomly assigned to each group. Patient demographic and clinical characteristics were similar among groups. There were no significant differences among groups for postoperative pain at rest or on mobilization at 8 and 24 hours after surgery. No significant differences were observed for interleukin-1β, interleukin-6, and interleukin-10 at any time points in any groups. Patients with local anesthesia was associated with less time spent in anesthesia (p = 0.010) and surgery (p = 0.009), lower intraoperative cost (p = 0.003) and total cost in hospital (p = 0.036); however, patient satisfaction in the local anesthesia group (94/100) was statistically significantly lower than the spinal and general anesthesia groups (100/100) (p = 0.010).
CONCLUSIONS
No statistically significant difference was observed among groups for postoperative pain scores, duration of hospital stays, complications, or change in inflammatory markers. However, time spent in anesthesia and surgery, the intraoperative cost and total cost for hernia repair, and patient satisfaction were significantly lower in the local anesthesia group than in the other two groups.",2020,"No significant differences were observed for interleukin-1β, interleukin-6, and interleukin-10 at any time points in any groups.","['Fifty-four patients were included, with 18 patients randomly assigned to each group', 'patients scheduled to undergo elective unilateral inguinal hernioplasty at Siriraj Hospital during November 2014 to September 2015 study period', 'patients who were anesthetized using local, spinal, or general anesthesia for inguinal hernia repair', 'inguinal hernia repair']","['local (LA), spinal (SA), or general (GA) anesthesia groups', 'inguinal hernia repair using local, spinal, or general anesthesia']","['postoperative pain at rest and on mobilization', 'time spent in anesthesia', 'postoperative pain scores, duration of hospital stays, complications, or change in inflammatory markers', 'interleukin-1β, interleukin-6, and interleukin-10 at any time points', 'lower intraoperative cost', 'total cost in hospital', 'patient satisfaction', 'time spent in anesthesia and surgery, the intraoperative cost and total cost for hernia repair, and patient satisfaction', 'postoperative pain at rest or on mobilization']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4284593', 'cui_str': 'Inguinal hernioplasty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}]",54.0,0.243606,"No significant differences were observed for interleukin-1β, interleukin-6, and interleukin-10 at any time points in any groups.","[{'ForeName': 'Mingkwan', 'Initials': 'M', 'LastName': 'Wongyingsinn', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pasawang', 'Initials': 'P', 'LastName': 'Kohmongkoludom', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Atthaphorn', 'Initials': 'A', 'LastName': 'Trakarnsanga', 'Affiliation': 'Division of General Surgery, Department of Surgery, Minimally Invasive Surgery Unit, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Horthongkham', 'Affiliation': 'Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0242925']
3004,33253259,Eating self-efficacy changes in individuals with type 2 diabetes following a structured lifestyle intervention based on the transcultural Diabetes Nutrition Algorithm (tDNA): A secondary analysis of a randomized controlled trial.,"OBJECTIVE
Eating self-efficacy behavior is an important predictor of successful lifestyle intervention. This secondary analysis evaluated the changes in eating self-efficacy behavior in patients with type 2 diabetes (T2D) and overweight/obesity following structured lifestyle intervention based on the Malaysian customized transcultural Diabetes Nutrition Algorithm (tDNA).
METHODS
Patients with T2D and overweight/obesity (n = 230) were randomized either into the tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual T2D care (UC) for 6 months. Patients in the tDNA group also received either counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice using conventional counseling. Eating self-efficacy was assessed using a locally validated Weight Efficacy Lifestyle (WEL) questionnaire. All patients were followed up for additional 6 months' post-intervention.
RESULTS
There was a significant change in WEL scores with intervention over one-year [Group X Time effect: F = 51.4, df = (3.4, 318.7), p<0.001]. Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC: -6.9±1.9, p<0.001). At 12 months' follow-up, both the tDNA groups maintained improvement in the WEL scores, with significantly higher scores in the tDNA-MI group than tDNA-CC group, and the UC group had decreased WEL scores (tDNA-MI: 28.9±3.1 vs. tDNA-CC: 11.6±3.6 vs. UC: -13.2±2.1, p<0.001). Patients in the tDNA-MI group with greater weight loss and hemoglobin A1C reduction also had a higher eating self-efficacy, with a similar trend observed in comparative groups.
CONCLUSION
Eating self-efficacy improved in patients with T2D and overweight/obesity who maintained their weight loss and glycemic control following a structured lifestyle intervention based on the Malaysian customized tDNA and the improvement was further enhanced with motivational interviewing.
CLINICAL TRIAL
This randomized clinical trial was registered under National Medical Research Registry, Ministry of Health Malaysia with registration number: NMRR-14-1042-19455 and also under ClinicalTrials.gov with registration number: NCT03881540.",2020,"Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC","['Patients with T2D and overweight/obesity (n = 230', 'patients with type 2 diabetes (T2D) and overweight/obesity following', 'individuals with type 2 diabetes', 'patients with T2D and overweight/obesity']","['tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual', 'transcultural Diabetes Nutrition Algorithm (tDNA', 'counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC', 'structured lifestyle intervention', 'standard dietary and exercise advice using conventional counseling', 'structured lifestyle intervention based on the Malaysian customized transcultural Diabetes Nutrition Algorithm (tDNA']","['eating self-efficacy behavior', 'locally validated Weight Efficacy Lifestyle (WEL) questionnaire', 'eating self-efficacy', 'Eating self-efficacy changes', 'Eating self-efficacy', 'WEL scores', 'weight loss and hemoglobin A1C reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0596014', 'cui_str': 'Does plan meals'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0243126', 'cui_str': 'incorporation'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0418878', 'cui_str': 'Recommendation to exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",230.0,0.0300512,"Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC","[{'ForeName': 'Harvinder Kaur', 'Initials': 'HK', 'LastName': 'Gilcharan Singh', 'Affiliation': 'Division of Nutrition and Dietetics, School of Health Sciences, International Medical University, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Winnie Siew Swee', 'Initials': 'WSS', 'LastName': 'Chee', 'Affiliation': 'Division of Nutrition and Dietetics, School of Health Sciences, International Medical University, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Hamdy', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Joslin Diabetes Center, Harvard Medical School, Boston, United States of America.'}, {'ForeName': 'Jeffrey Ian', 'Initials': 'JI', 'LastName': 'Mechanick', 'Affiliation': 'Division of Endocrinology, Diabetes and Bone Disease, Icahn School of Medicine at Mount Sinai, New York, United States of America.'}, {'ForeName': 'Verna Kar Mun', 'Initials': 'VKM', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, School of Medicine, International Medical University, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Barua', 'Affiliation': 'Department of Community Medicine, School of Medicine, International Medical University, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Siti Zubaidah', 'Initials': 'SZ', 'LastName': 'Mohd Ali', 'Affiliation': 'Department of Non-Communicable Diseases, Klinik Kesihatan Seremban, Negeri Sembilan, Malaysia.'}, {'ForeName': 'Zanariah', 'Initials': 'Z', 'LastName': 'Hussein', 'Affiliation': 'Department of Medicine, Hospital Putrajaya, Pusat Pentadbiran Kerajaan Persekutuan, Putrajaya, Malaysia.'}]",PloS one,['10.1371/journal.pone.0242487']
3005,33253237,Computer-based inhibitory control training in children with Attention-Deficit/Hyperactivity Disorder (ADHD): Evidence for behavioral and neural impact.,"Attention-deficit hyperactivity disorder (ADHD) is the most commonly diagnosed psychological disorder of childhood. Medication and cognitive behavioral therapy are effective treatments for many children; however, adherence to medication and therapy regimens is low. Thus, identifying effective adjunct treatments is imperative. Previous studies exploring computerized training programs as supplementary treatments have targeted working memory or attention. However, many lines of research suggest inhibitory control (IC) plays a central role in ADHD pathophysiology, which makes IC a potential intervention target. In this randomized control trial (NCT03363568), we target IC using a modified stop-signal task (SST) training designed by NeuroScouting, LLC in 40 children with ADHD, aged 8 to 11 years. Children were randomly assigned to adaptive treatment (n = 20) or non-adaptive control (n = 20) with identical stimuli and task goals. Children trained at home for at least 5 days a week (about 15m/day) for 4-weeks. Relative to the control group, the treatment group showed decreased relative theta power in resting EEG and trending improvements in parent ratings of attention (i.e. decreases in inattentive behaviors). Both groups showed improved SST performance. There was not evidence for treatment effects on hyperactivity or teacher ratings of symptoms. Results suggest training IC alone has potential to positively impact symptoms of ADHD and provide evidence for neural underpinnings of this impact (change in theta power; change in N200 latency). This shows promising initial results for the use of computerized training of IC in children with ADHD as a potential adjunct treatment option for children with ADHD.",2020,"Relative to the control group, the treatment group showed decreased relative theta power in resting EEG and trending improvements in parent ratings of attention (i.e. decreases in inattentive behaviors).","['children with ADHD', 'children with Attention-Deficit/Hyperactivity Disorder (ADHD', '40 children with ADHD, aged 8 to 11 years']","['adaptive treatment (n = 20) or non-adaptive control (n = 20) with identical stimuli and task goals', 'Computer-based inhibitory control training', 'Medication and cognitive behavioral therapy', 'modified stop-signal task (SST) training designed by NeuroScouting, LLC']","['relative theta power in resting EEG', 'SST performance', 'hyperactivity or teacher ratings of symptoms']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",40.0,0.067256,"Relative to the control group, the treatment group showed decreased relative theta power in resting EEG and trending improvements in parent ratings of attention (i.e. decreases in inattentive behaviors).","[{'ForeName': 'Kristin N', 'Initials': 'KN', 'LastName': 'Meyer', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, NC, United States of America.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Santillana', 'Affiliation': 'Davis Medical School, University of California, Sacramento, California, United States of America.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Miller', 'Affiliation': 'NeuroScouting, LLC, Cambridge, MA, United States of America.'}, {'ForeName': 'Wes', 'Initials': 'W', 'LastName': 'Clapp', 'Affiliation': 'NeuroScouting, LLC, Cambridge, MA, United States of America.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Way', 'Affiliation': 'Amazon, Boston, MA, United States of America.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Bridgman-Goines', 'Affiliation': 'Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Sheridan', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0241352']
3006,33253017,Efficacy of contact intervention videos on college students' intentions toward mental health help-seeking.,"OBJECTIVE
Untreated mental health (MH) concerns have significant implications for college students. This study examined the efficacy of a video contact intervention targeting students' intentions to seek counseling. Participants: One-hundred and sixty-three college students ( M age = 21.05, SD = 2.20) from a Mid-Atlantic university participated. The sample was predominantly female (74%). Method: Students were randomly assigned to view a student-targeted contact video (ie, clips from college students who share their mental health experiences), a MH comparison contact video, or a non-MH comparison video. Intentions to seek counseling and psychological distress were measured pretest and post-test. Results: Intentions to seek counseling significantly increased from pretest to post-test in the student-targeted contact video condition ( F [1, 156] = 22.75, p < .001, partial η 2 = .13), but not in the comparison conditions. Further, this effect was only observed among participants who reported preexisting psychological distress ( F [1, 153] = 28.00, p < .001, partial η 2 = .16). Conclusions: This study provides initial support for the utility of a student-targeted contact intervention video for increasing help-seeking intentions among those reporting current psychological distress.",2020,"Results: Intentions to seek counseling significantly increased from pretest to post-test in the student-targeted contact video condition ( F [1, 156] = 22.75, p < .001, partial η 2 = .13), but not in the comparison conditions.","['college students', 'One-hundred and sixty-three college students ( M age = 21.05, SD \u2009=\u20092.20) from a Mid-Atlantic university participated', ""college students' intentions toward mental health help-seeking"", 'Participants']","['contact intervention videos', 'video contact intervention', 'student-targeted contact intervention video', 'student-targeted contact video (ie, clips from college students who share their mental health experiences), a MH comparison contact video, or a non-MH comparison video']","['preexisting psychological distress', 'Intentions to seek counseling significantly increased from pretest to post-test in the student-targeted contact video condition']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",163.0,0.0237814,"Results: Intentions to seek counseling significantly increased from pretest to post-test in the student-targeted contact video condition ( F [1, 156] = 22.75, p < .001, partial η 2 = .13), but not in the comparison conditions.","[{'ForeName': 'Eryn', 'Initials': 'E', 'LastName': 'Kruger', 'Affiliation': 'Department of Psychology, University of Maryland, Baltimore County, Baltimore, Maryland, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Pitts', 'Affiliation': 'Department of Psychology, University of Maryland, Baltimore County, Baltimore, Maryland, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Denenny', 'Affiliation': 'Division of Child and Adolescent Psychiatry, UCLA Jane & Terry Semel Institute for Neuroscience & Human Behavior, Los Angeles, California, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'DeLuca', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Schiffman', 'Affiliation': 'Department of Psychology, University of Maryland, Baltimore County, Baltimore, Maryland, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1842417']
3007,33252989,Effect of exercise on sleep and bi-directional associations with accelerometer-assessed physical activity in men with obesity.,"This study examined the effect of exercise training on sleep duration and quality and bidirectional day-to-day relationships between physical activity (PA) and sleep. Fourteen inactive men with obesity (49.2±7.9 years, BMI 34.9±2.8 kg/m²) completed a baseline visit, eight-week aerobic exercise intervention, and one-month post-intervention follow-up. PA and sleep were assessed continuously throughout the study duration using wrist-worn accelerometry. Generalised estimating equations (GEE) were used to examine associations between PA and sleep. Sleep duration increased from 5.2h at baseline to 6.6h during the intervention period and 6.5h at one-month post-intervention follow-up (p<0.001). Bi-directional associations showed that higher overall activity volume and moderate-to-vigorous physical activity (MVPA) were associated with earlier sleep onset time (p<0.05). Later timing of sleep onset was associated with lower overall volume of activity, most active continuous 30 minutes (M30CONT), and MVPA (p<0.05). Higher overall activity volume, M30CONT, and MVPA predicted more wake after sleep onset (WASO) (p<0.001), whereas greater WASO was associated with higher overall volume of activity, M30CONT, and MVPA (p<0.001). An aerobic exercise intervention increased usual sleep duration. Day-to-day, more PA predicted earlier sleep onset, but worse sleep quality and vice versa. Novelty: • Greater levels of physical activity in the day were associated with an earlier sleep onset time that night, whereas a later timing of sleep onset was associated with lower physical activity the next day in men with obesity • Higher physical activity levels were associated with worse sleep quality, and vice versa.",2020,"Greater levels of physical activity in the day were associated with an earlier sleep onset time that night, whereas a later timing of sleep onset was associated with lower physical activity the next day in men with obesity •","['Fourteen inactive men with obesity (49.2±7.9 years, BMI 34.9±2.8 kg/m²', 'men with obesity •', 'men with obesity']","['aerobic exercise intervention', 'aerobic exercise intervention, and one-month post-intervention follow-up', 'exercise', 'accelerometer-assessed physical activity', 'exercise training']","['sleep duration and quality and bidirectional day-to-day relationships between physical activity (PA) and sleep', 'sleep quality, and vice versa', 'Higher physical activity levels', 'overall activity volume and moderate-to-vigorous physical activity (MVPA', 'Novelty', 'sleep quality and vice versa', 'PA and sleep', 'overall volume of activity, M30CONT, and MVPA (p<0.001', 'Sleep duration', 'usual sleep duration', 'Higher overall activity volume, M30CONT, and MVPA predicted more wake after sleep onset (WASO', 'Greater levels of physical activity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",14.0,0.016597,"Greater levels of physical activity in the day were associated with an earlier sleep onset time that night, whereas a later timing of sleep onset was associated with lower physical activity the next day in men with obesity •","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Plekhanova', 'Affiliation': 'University of Leicester, 4488, Diabetes Research Centre, Gwendolen Road, Leicester, Leicester, United Kingdom of Great Britain and Northern Ireland, LE5 4PW; tp177@le.ac.uk.'}, {'ForeName': 'Alex V', 'Initials': 'AV', 'LastName': 'Rowlands', 'Affiliation': 'University of Leicester, 4488, Diabetes Research Centre, Leicester, Leicestershire, United Kingdom of Great Britain and Northern Ireland; alex.rowlands@leicester.ac.uk.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'University of Leicester, 4488, Diabetes Research Centre, Leicester, Leicestershire, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'University of Leicester, 4488, Diabetes Research Centre, Leicester, United Kingdom of Great Britain and Northern Ireland; ce95@le.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'University Hospitals of Leicester NHS Trust, 4490, Leicester, Leicester, United Kingdom of Great Britain and Northern Ireland; andrew.p.hall@uhl-tr.nhs.uk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'University of Leicester, 4488, Diabetes Research Centre, Leicester, United Kingdom of Great Britain and Northern Ireland; Ty20@le.ac.uk.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2020-0361']
3008,33252985,"Reduced All-Cause Mortality in the ETHOS Trial of Budesonide/Glycopyrrolate/Formoterol for COPD: A Randomized, Double-Blind, Multi-Center Parallel-Group Study.","RATIONALE
In the Phase III, 52-week ETHOS trial in COPD (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) significantly reduced all-cause mortality versus glycopyrrolate/formoterol fumarate (GFF). However, 384 out of 8,509 patients were missing vital status at Week 52 in the original analyses.
OBJECTIVE
To assess the robustness of the ETHOS mortality findings following additional data retrieval for patients missing Week 52 vital status in the original analyses.
METHODS
Patients with moderate-to-very severe COPD and prior history of exacerbation received twice-daily dosing with BGF 320/18/9.6 µg or 160/18/9.6 μg, GFF 18/9.6 µg, or budesonide/formoterol fumarate (BFF) 320/9.6 µg (all delivered via a single metered dose Aerosphere inhaler). Time to death (all-cause) was a pre-specified secondary endpoint.
MEASUREMENTS AND MAIN RESULTS
In the final retrieved dataset, which included Week 52 vital status for 99.6% of the intent-to-treat population, risk of death with BGF 320 was significantly lower versus GFF (hazard ratio [HR] 0.51, 95% confidence interval [CI] 0.33‒0.80; unadjusted P=0.0035). There were no significant differences in mortality when comparing BGF 320 to BFF (HR 0.72, 95% CI 0.44‒1.16; P=0.1721), nor were significant differences observed when comparing BGF 160 against either dual comparator. Results were similar when the first 30, 60, or 90 days of treatment were excluded from the analysis. Deaths from cardiovascular causes occurred in 0.5%, 0.8%, 1.4%, and 0.5% of patients in the BGF 320, BGF 160, GFF, and BFF groups, respectively.
CONCLUSIONS
Using final retrieved vital status data, triple therapy with BGF 320/18/9.6 μg reduced the risk of death compared with GFF, but was not shown to significantly reduce the risk of death compared with BFF, in patients with COPD. Triple therapy containing a lower dose of inhaled corticosteroid (BGF 160/18/9.6 μg) was not shown to significantly reduce risk of death compared with the dual therapy comparators. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02465567. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2020,"There were no significant differences in mortality when comparing BGF 320 to BFF (HR 0.72, 95% CI 0.44‒1.16; P=0.1721), nor were significant differences observed when comparing BGF 160 against either dual comparator.","['COPD', 'patients missing Week 52 vital status in the original analyses', '384 out of 8,509 patients were', 'patients with COPD', 'Patients with moderate-to-very severe COPD and prior history of exacerbation received twice-daily dosing with BGF 320/18/9.6 µg or 160/18/9.6 μg, GFF 18/9.6 µg, or']","['glycopyrrolate/formoterol fumarate (GFF', 'budesonide/formoterol fumarate (BFF', 'Budesonide/Glycopyrrolate/Formoterol', 'inhaled corticosteroid', 'budesonide/glycopyrrolate/formoterol fumarate (BGF']","['Deaths from cardiovascular causes', 'mortality', 'risk of death', 'Time to death', 'missing vital status']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0771469', 'cui_str': 'Formoterol fumarate'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0016801', 'cui_str': 'Fumarates'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",8509.0,0.384893,"There were no significant differences in mortality when comparing BGF 320 to BFF (HR 0.72, 95% CI 0.44‒1.16; P=0.1721), nor were significant differences observed when comparing BGF 160 against either dual comparator.","[{'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, New York, United States; fjm2003@med.cornell.edu.'}, {'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan, United States.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Centre for Respiratory Diseases, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Rossman', 'Affiliation': 'Formerly of AstraZeneca, Morristown, New Jersey, United States.'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'Formerly of AstraZeneca, Morristown, New Jersey, United States.'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'AstraZeneca, Durham, North Carolina, United States.'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'Formerly of AstraZeneca, Morristown, New Jersey, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'AstraZeneca, Wilmington, Delaware, United States.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'Formerly of AstraZeneca, Morristown, New Jersey, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'AstraZeneca, Durham, North Carolina, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202006-2618OC']
3009,33252964,Alcohol-involved sexual aggression: Emotion regulation as a mechanism of behavior change.,"OBJECTIVE
Sexual aggression remains a significant public health problem, with the majority of sexual assaults involving alcohol. Founded upon an experimental medicine approach to behavior change, the current study used a proximal change experiment to target and test emotion regulation (ER) as a mechanism underlying alcohol-involved sexual aggression.
METHOD
Heavy episodic drinking men aged 21-30 with a sexual assault perpetration history (N = 209) were randomly assigned to a brief, online, ER-focused cognitive restructuring or mindfulness intervention or to control. Intervention effects were evaluated during sober and intoxicated states through laboratory-based alcohol administration (target BrAC = .08%). Intoxicated and sober participants completed a proximal change protocol that included implementing ER skills during a sexual aggression analogue that assessed relevant emotions and intentions.
RESULTS
Path analysis demonstrated that relative to control, the cognitive restructuring intervention improved emotional modulation and emotional clarity, resulting in lower sexual arousal and anger, respectively, followed by decreased sexual coercion intentions. The mindfulness intervention yielded mixed results, predicting decreased sexual aggression intentions compared to control but also predicting stronger coercive tactic intentions in intoxicated men with more severe sexual aggression histories. Both interventions improved emotional acceptance relative to control, but only for sober men.
CONCLUSIONS
Overall, the current study demonstrated that ER-focused interventions improved proximal ER skills associated with reduced sexual aggression intentions, signifying ER as an important mechanism for changing sexually aggressive behavior. Because intervention efficacy varied by intoxication state, further research is needed to assess the effectiveness of ER interventions targeting real-world alcohol-involved sexual aggression. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"The mindfulness intervention yielded mixed results, predicting decreased sexual aggression intentions compared to control but also predicting stronger coercive tactic intentions in intoxicated men with more severe sexual aggression histories.",['Heavy episodic drinking men aged 21-30 with a sexual assault perpetration history (N = 209'],"['online, ER-focused cognitive restructuring or mindfulness intervention or to control']","['sexual coercion intentions', 'sexual aggression intentions', 'emotional acceptance', 'proximal ER skills', 'emotional modulation and emotional clarity, resulting in lower sexual arousal and anger']","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault'}, {'cui': 'C0019664', 'cui_str': 'History'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0150173', 'cui_str': 'Cognitive restructuring'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0233953', 'cui_str': 'Sexual aggression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0233972', 'cui_str': 'Sexual excitation'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",209.0,0.0311135,"The mindfulness intervention yielded mixed results, predicting decreased sexual aggression intentions compared to control but also predicting stronger coercive tactic intentions in intoxicated men with more severe sexual aggression histories.","[{'ForeName': 'Kelly Cue', 'Initials': 'KC', 'LastName': 'Davis', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Neilson', 'Affiliation': 'Department of Psychology, Morehead State University.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Kirwan', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University.'}, {'ForeName': 'Nolan', 'Initials': 'N', 'LastName': 'Eldridge', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'George', 'Affiliation': 'Department of Psychology, University of Washington.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Stappenbeck', 'Affiliation': 'Department of Psychology, Georgia State University.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0001048']
3010,33252951,A hybrid effectiveness/implementation trial of an evidence-based intervention for HIV-serodiscordant African American couples.,"Couples-based behavioral HIV prevention interventions have demonstrated efficacy, but few are routinely available in community-based settings in the United States. The Eban intervention, designed for heterosexual African American serodiscordant couples and proven efficacious in a cluster randomized trial, was implemented in community-based HIV service organizations in two cities disproportionately affected by the HIV epidemic. This article reports primarily on the effectiveness results related to condom use and results related to retention challenges within a Hybrid Type 2 implementation/effectiveness trial. Ninety-one individuals enrolled at baseline; 39 completed the posttest, and 30 completed the 3-month follow-up. Although condom use did not monotonically increase from baseline to posttest and 3-month follow-up, it did increase from baseline (44%) to posttest (73%), and from baseline to 3-month follow-up with an overall positive slope of Time 0.13 to 0.14 (p < .001). There was a significant increase in the number of people who used condoms 100% of the time from baseline (36.3%) to posttest (56.4%; p = .04) but not from baseline to 3-month follow-up (46.7%; p = .2907). Challenges with resources as basic as housing, food, and transportation complicated participation (and therefore implementation) and may have impeded couples' maintenance of risk reduction strategies beyond the intervention. In light of couples' numerous observed vulnerabilities, we constructed a composite score of ""critical vulnerability"" and found that depression was persistently related to critical vulnerability and that retention was higher among those with less vulnerability. These findings highlight the important yet underaddressed role of patient-level factors in the process and outcomes of hybrid implementation/effectiveness research. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Although condom use did not monotonically increase from baseline to posttest and 3-month follow-up, it did increase from baseline (44%) to posttest (73%), and from baseline to 3-month follow-up with an overall positive slope of Time 0.13 to 0.14 (p < .001).","['heterosexual African American serodiscordant couples and proven efficacious in a cluster randomized trial, was implemented in community-based HIV service organizations in two cities disproportionately affected by the HIV epidemic', 'Ninety-one individuals enrolled at baseline; 39 completed the posttest, and 30 completed the 3-month follow-up', 'HIV-serodiscordant African American couples']",['evidence-based intervention'],['number of people who used condoms'],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]",91.0,0.0561194,"Although condom use did not monotonically increase from baseline to posttest and 3-month follow-up, it did increase from baseline (44%) to posttest (73%), and from baseline to 3-month follow-up with an overall positive slope of Time 0.13 to 0.14 (p < .001).","[{'ForeName': 'Gail E', 'Initials': 'GE', 'LastName': 'Wyatt', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Alison B', 'Initials': 'AB', 'LastName': 'Hamilton', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Tamra Burns', 'Initials': 'TB', 'LastName': 'Loeb', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Moss', 'Affiliation': 'Division of Communicable Disease Control and Prevention, Alameda County Public Health Department.'}, {'ForeName': 'Muyu', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles.'}, {'ForeName': 'Honghu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles.'}]",The American psychologist,['10.1037/amp0000712']
3011,33252943,User-informed marketing versus standard description to drive demand for evidence-based therapy: A randomized controlled trial.,"Direct-to-consumer (DTC) marketing represents a vital strategy to disseminate evidence-based therapies (EBTs). This 3-phase research program, informed by the marketing mix, developed and evaluated user-informed DTC materials for parents concerned about adolescent substance use (SU). Phases 1 and 2 consisted of qualitative interviews (n = 29 parents) and a quantitative survey (n = 411), respectively, to elicit parents' preferred terms and strategies to disseminate EBT. Building upon prior phases, the current study (Phase 3) developed a user-informed infographic (128 words, 7th-grade level) focused on SU therapy. Parents were randomly assigned to view the user-informed infographic (n = 75) or a standard EBT description (n = 77) from the American Psychological Association (529 words, 12th-grade level). Logistic regressions examined the effect of marketing condition on parent-reported behavioral intentions and actual requests for EBT information, controlling for correlates of parent preferences in Phase 2 (parent education level; adolescent internalizing, externalizing, legal, and SU problems). Counter to hypotheses, condition did not have a main effect on either outcome. However, there was a significant interaction between condition and adolescent SU problems: among parents whose adolescents had SU problems, the user-informed infographic predicted 3.7 times higher odds of requesting EBT information than the standard description. Additionally, parents whose adolescents had legal problems were more likely to request EBT information than parents whose adolescents did not. The infographic was 4 times shorter and written at 5 grade levels lower, thereby providing a highly disseminable alternative. Findings highlight the value of specificity in DTC marketing, while advancing methods to create tailored marketing materials and communicate knowledge about psychological science. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Counter to hypotheses, condition did not have a main effect on either outcome.",[],"['standard EBT description', 'Direct-to-consumer (DTC) marketing']","['request EBT information', 'legal problems']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0024826', 'cui_str': 'Marketing'}]","[{'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0362060', 'cui_str': 'Legal problem'}]",,0.0353289,"Counter to hypotheses, condition did not have a main effect on either outcome.","[{'ForeName': 'Sara J', 'Initials': 'SJ', 'LastName': 'Becker', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Helseth', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University.'}, {'ForeName': 'Tonya L', 'Initials': 'TL', 'LastName': 'Tavares', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Squires', 'Affiliation': 'Center for Alcohol and Addiction Studies, School of Public Health, Brown University.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Clark', 'Affiliation': 'Department of Health Services, Policy, and Practice, School of Public Health, Brown University.'}, {'ForeName': 'Valarie A', 'Initials': 'VA', 'LastName': 'Zeithaml', 'Affiliation': 'Department of Marketing, Kenan-Flagler Business School, University of North Carolina.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Spirito', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School, Brown University.'}]",The American psychologist,['10.1037/amp0000635']
3012,33252936,"The thrill of victory: Savoring positive affect, psychophysiological reward processing, and symptoms of depression.","Depression is characterized by a pattern of maladaptive emotion regulation. Recently, researchers have begun to focus on associations between depression and two positive affect regulation strategies: savoring and dampening. Savoring, or upregulation of positive affect, is positively associated with well-being and negatively associated with depression, whereas dampening, or downregulation of positive affect, is positively associated with depression, anhedonia, and negative affect. To date, no research has examined whether savoring or dampening can affect neurophysiological reactivity to reward, which previous research has shown is associated with symptoms of depression. Here, we examined associations between psychophysiological reward processing-primarily captured by the Reward Positivity (RewP), an event-related potential (ERP) deflection elicited by feedback indicating reward (vs. nonreward)-positive affect regulation strategies, and symptoms of depression. One hundred undergraduates completed questionnaires assessing affect, emotion regulation, and depressive symptoms and completed a computerized guessing task, once before and again after being randomly assigned to emotion-regulation strategy conditions. Results indicate that (a) the relationship between RewP amplitude and depressive symptoms may, in part, depend upon positive affect regulation strategies and (b) the RewP elicited by reward appears sensitive to a savoring intervention. These findings suggest that mitigating depressive symptoms in emerging adults may depend on both top-down (i.e., savoring) and bottom-up (i.e., RewP) forms of positive affect regulation and have important implications for clinical prevention and intervention efforts for depressive symptoms and disorder. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Savoring, or upregulation of positive affect, is positively associated with well-being and negatively associated with depression, whereas dampening, or downregulation of positive affect, is positively associated with depression, anhedonia, and negative affect.",['One hundred undergraduates completed'],[],"['psychophysiological reward processing, and symptoms of depression', 'questionnaires assessing affect, emotion regulation, and depressive symptoms']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",[],"[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0505547,"Savoring, or upregulation of positive affect, is positively associated with well-being and negatively associated with depression, whereas dampening, or downregulation of positive affect, is positively associated with depression, anhedonia, and negative affect.","[{'ForeName': 'Kelsey M', 'Initials': 'KM', 'LastName': 'Irvin', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Debora J', 'Initials': 'DJ', 'LastName': 'Bell', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Steinley', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bartholow', 'Affiliation': 'Department of Psychological Sciences.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000914']
3013,33252930,Just-in-time adaptive intervention to promote fluid consumption in patients with kidney stones.,"OBJECTIVE
Kidney stones are painful and costly. Prevention guidelines emphasize a simple behavior change: increasing fluid intake and urine output. Unfortunately, adherence to those prevention guidelines is limited, and patients report forgetting or not being thirsty enough. This study evaluated the acceptability of using semiautomated tracking of fluid consumption to trigger just-in-time reminders to drink and increase the experienced automaticity of fluid intake.
METHOD
In a single-group trial, participants with a history of kidney stones (n = 31) used the sip IT digital tools (H2OPal connected water bottle, H2OPal mobile app for self-tracking, Fitbit smartwatch app for gesture detection) for 3 months.
RESULTS
The semiautomated monitoring system detected 46,654 drinking events. From baseline to 1-month follow-up, the experienced automaticity of fluid intake increased significantly (d = 0.50) and remained elevated at 3-month follow-up (d = 0.64). A major barrier to adherence (lack of thirst) decreased from baseline to follow-ups. Retention rates and participant feedback indicated that this digital tool was acceptable to patients.
CONCLUSION
Semiautomated tracking of fluid consumption can be used to trigger just-in-time reminders. Based on this demonstration, the sip IT tools are ready for testing in a rigorous Phase II trial to evaluate efficacy for increasing fluid consumption and urine output as recommended for preventing the recurrence of kidney stones. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"This study evaluated the acceptability of using semiautomated tracking of fluid consumption to trigger just-in-time reminders to drink and increase the experienced automaticity of fluid intake.
","['participants with a history of kidney stones (n = 31', 'patients with kidney stones']","['sip IT digital tools (H2OPal connected water bottle, H2OPal mobile app for self-tracking, Fitbit smartwatch app for gesture detection', 'Just-in-time adaptive intervention']","['Retention rates and participant feedback', 'automaticity of fluid intake']","[{'cui': 'C1998388', 'cui_str': 'History of calculus of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}]",,0.0358591,"This study evaluated the acceptability of using semiautomated tracking of fluid consumption to trigger just-in-time reminders to drink and increase the experienced automaticity of fluid intake.
","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Conroy', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Ashley B', 'Initials': 'AB', 'LastName': 'West', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Brunke-Reese', 'Affiliation': 'Department of Kinesiology.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Thomaz', 'Affiliation': 'Department of Electrical and Computer Engineering.'}, {'ForeName': 'Necole M', 'Initials': 'NM', 'LastName': 'Streeper', 'Affiliation': 'Division of Urology.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0001032']
3014,33252929,Patient-provided e-support in reduced intensity obesity treatment: The INSPIRE randomized controlled trial.,"OBJECTIVE
There are two types of patient supporters, peers (two individuals initiating health behavior change who support one another) and mentors (a previously successful patient who supports incoming patients). Social comparison theory suggests that peers and mentors may elicit social comparison processes (patients may compare their progress to that of their peer/mentor), and these social comparisons could impact treatment outcomes. This randomized controlled trial is the first to examine the differential impact of peers and mentors on obesity treatment outcomes and social comparison processes when added to reduced intensity treatment.
METHOD
Participants (N = 278) were randomly assigned to reduced intensity behavioral weight loss treatment alone (rBWL), rBWL plus peer e-support (rBWL + Peer), or rBWL plus mentor e-support (rBWL + Mentor). rBWL involved periodic group sessions that decreased over time; when group sessions decreased, intensity of peer/mentor e-support increased. Weight and social comparison processes were assessed throughout the 12-month intervention.
RESULTS
There was a significant treatment effect; when group sessions became less frequent and peer/mentor e-support became more frequent, rBWL + Peer had significantly greater weight loss than rBWL alone, and rBWL + Mentor was not significantly different from the other two. Social comparison processes differed by treatment arm; rBWL + Peer participants tended to report more lateral social comparisons (""my weight loss progress is 'similar' to my peer's""), whereas rBWL + Mentor participants reported more upward comparisons (""my weight loss progress is 'worse than' my mentor's""). Upward comparisons were associated with poorer weight loss outcomes.
CONCLUSIONS
Peer e-support may be an effective, low-cost, sustainable method for improving longer-term weight loss outcomes in reduced intensity obesity treatment. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Social comparison processes differed by treatment arm; rBWL + Peer participants tended to report more lateral social comparisons,"['patient supporters, peers (two individuals initiating health behavior change who support one another) and mentors (a previously successful patient who supports incoming patients', 'Participants (N = 278']","['intensity behavioral weight loss treatment alone (rBWL), rBWL plus peer e-support']","['weight loss', 'rBWL + Mentor', 'lateral social comparisons', 'poorer weight loss outcomes', 'Weight and social comparison processes', 'intensity of peer/mentor e-support increased']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",278.0,0.0535292,Social comparison processes differed by treatment arm; rBWL + Peer participants tended to report more lateral social comparisons,"[{'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Sciences.'}, {'ForeName': 'Tania B', 'Initials': 'TB', 'LastName': 'Huedo-Medina', 'Affiliation': 'Department of Allied Health Sciences.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Grenga', 'Affiliation': 'Weight Control and Diabetes Research Center.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gay', 'Affiliation': 'Weight Control and Diabetes Research Center.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Fernandes', 'Affiliation': 'Weight Control and Diabetes Research Center.'}, {'ForeName': 'Zeely', 'Initials': 'Z', 'LastName': 'Denmat', 'Affiliation': 'Institute for Collaboration on Health, Intervention and Policy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Doyle', 'Affiliation': 'Weight Control and Diabetes Research Center.'}, {'ForeName': 'Remei', 'Initials': 'R', 'LastName': 'Areny-Joval', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000996']
3015,33259073,Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial.,"AIMS
To compare the effectiveness and safety of polypropylene (PP) and polyvinylidene fluoride (PVDF) transobturator tapes (TOT) for the treatment of female stress urinary incontinence (SUI).
METHODS
This is a multicentre randomized trial. Women with SUI or stress-predominant mixed urinary incontinence and scheduled for a TOT procedure were randomized to PP or PVDF slings. The primary outcome was 1-year cure or improvement rate using composite criteria. Complications were also compared. Relationships with outcomes were analyzed using multivariable logistic regressions models.
RESULTS
From April 2016 to January 2018 285 participants were randomized. PP and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%, p = .138). Improvement in validated questionnaires was also similar. PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15-0.80). We found no statistical differences in complications rates, although a higher incidence of long-term pain events were observed in the PP group. The study is underpowered to find differences in specific complications owing to the low number of events.
CONCLUSION
PP and PVDF TOTs are equally effective, although PVDF is associated with fewer cases of de novo urgency incontinence. Further studies are needed to give robust conclusions on safety profiles.",2020,PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15-0.80).,"['female stress urinary incontinence (SUI', 'Women with SUI or stress-predominant mixed urinary incontinence and scheduled for a TOT procedure', 'female stress urinary incontinence', 'From April 2016 to January 2018 285 participants were randomized']","['polypropylene (PP) and polyvinylidene fluoride (PVDF) transobturator tapes (TOT', 'Polypropylene and polyvinylidene fluoride transobturator slings']","['rate of de novo urgency incontinence', '1-year cure or improvement rate', 'incidence of long-term pain events', 'cure or improvement rate', 'Complications', 'complications rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1721084', 'cui_str': 'Trans-Obturator Tape'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0032582', 'cui_str': 'Polypropylene'}, {'cui': 'C0071710', 'cui_str': 'polyvinylidene fluoride'}, {'cui': 'C1721084', 'cui_str': 'Trans-Obturator Tape'}, {'cui': 'C0183346', 'cui_str': 'Sling'}]","[{'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",285.0,0.11875,PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15-0.80).,"[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Sabadell', 'Affiliation': ""Urogynecology and Pelvic Floor Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pereda-Núñez', 'Affiliation': 'Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital General de Granollers, Barcelona, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ojeda-de-Los-Santos', 'Affiliation': 'Department of Gynecology, Hospital Quirón Sagrado Corazón, Sevilla, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Urbaneja', 'Affiliation': 'Department of Gynecology, Hospital Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'González-García', 'Affiliation': 'Department of Gynecology, Hospital de Viladecans, Barcelona, Spain.'}, {'ForeName': 'Narcís', 'Initials': 'N', 'LastName': 'Camps-Lloveras', 'Affiliation': 'Functional Urology and Urodynamics Unit, Department of Urology, Hospital Universitari de Bellvitge, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Àngela', 'Initials': 'À', 'LastName': 'Pérez-Plantado', 'Affiliation': 'Department of Gynecology, Hospital de Mataró, Consorci Sanitari del Maresme, Barcelona, Spain.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Canet-Rodríguez', 'Affiliation': 'Department of Gynecology, Hospital Santa Caterina de Salt, Girona, Spain.'}, {'ForeName': 'Maria Paz', 'Initials': 'MP', 'LastName': 'Pérez-Espejo', 'Affiliation': 'Department of Urology, Hospital General de Riotinto, Huelva, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Rodríguez-Mias', 'Affiliation': ""Urogynecology and Pelvic Floor Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Sarasa-Castelló', 'Affiliation': 'Pelvic Floor Unit, Department of Obstetrics and Gynecology, Hospital General de Granollers, Barcelona, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Palau', 'Affiliation': 'Department of Gynecology, Hospital Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Montero-Armengol', 'Affiliation': ""Urogynecology and Pelvic Floor Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Salicrú', 'Affiliation': ""Urogynecology and Pelvic Floor Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gil-Moreno', 'Affiliation': ""Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.""}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Poza', 'Affiliation': ""Urogynecology and Pelvic Floor Unit, Department of Gynecology, Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.""}]",Neurourology and urodynamics,['10.1002/nau.24586']
3016,33259001,Relationships between pathological factors and long-term outcomes in patients enrolled in two prospective randomized controlled trials comparing the efficacy of oral tegafur-uracil with CMF (N·SAS-BC 01 trial and CUBC trial).,"PURPOSE
To evaluate the efficacies of cyclophosphamide, methotrexate, and fluorouracil (CMF) and tegafur-uracil (UFT) as adjuvant therapy in patients with resected stage I-IIIA breast cancer by immunohistochemistry (IHC)-based subtype and to determine the relationships between clinicopathological factors and long-term outcomes.
METHODS
A pooled analysis of the randomized controlled N·SAS-BC 01 and CUBC studies was conducted. Expression of hormone receptors (HRs; estrogen and progesterone receptors), human epidermal growth factor receptor 2 (HER2), and Ki67were assessed by IHC. Tumor-infiltrating lymphocytes (TILs) and nuclear/histological grades were determined by hematoxylin and eosin staining. Relapse-free survival (RFS) and overall survival (OS) were estimated by Kaplan-Meier analysis and hazard ratios were determined by Cox model adjusted for baseline tumor size and nodal status.
RESULTS
A total of 689 patients (342 CMF and 347 UFT) were included in the analyses with a median follow-up of 11.1 years. There was no significant difference in RFS or OS between the two cohorts (RFS: 0.96 [95% confidence interval: 0.71-1.30], log-rank test p = 0.80; OS: 0.93 [0.64-1.35], p = 0.70). There was no difference in RFS or OS between the two cohorts for HR+/HER2- and HR+/HER2+ subtypes. RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR-/HER2+ subtype (0.30 [0.10-0.88], p = 0.03). A high TILs level was associated with a better OS compared with low TILs level (p = 0.02).
CONCLUSIONS
This long-term follow-up study showed that RFS and OS were similar in patients with luminal-type breast cancer treated with CMF and UFT.",2020,"RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR-/HER2+ subtype (0.30 [0.10-0.88], p = 0.03).","['patients with luminal-type breast cancer treated with', 'patients with resected stage I-IIIA breast cancer by immunohistochemistry (IHC)-based subtype', '689 patients (342 CMF and 347 UFT) were included in the analyses with a median follow-up of 11.1\xa0years']","['CMF and UFT', 'CMF', 'oral tegafur-uracil with CMF (N·SAS-BC', 'cyclophosphamide, methotrexate, and fluorouracil (CMF) and tegafur-uracil (UFT', 'UFT']","['Relapse-free survival (RFS) and overall survival (OS', 'Tumor-infiltrating lymphocytes (TILs) and nuclear/histological grades', 'RFS or OS', 'RFS', 'RFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C5191280', 'cui_str': '342'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1446539', 'cui_str': 'Tegafur- and uracil-containing product'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0456201', 'cui_str': 'Histological grades'}]",689.0,0.214985,"RFS was significantly longer in patients treated with UFT compared with CMF in patients with HR-/HER2+ subtype (0.30 [0.10-0.88], p = 0.03).","[{'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Ohno', 'Affiliation': 'Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. shinji.ohno@jfcr.or.jp.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Masuda', 'Affiliation': 'National Hospital Organization Osaka National Hospital, Osaka, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Tsuda', 'Affiliation': 'National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Futoshi', 'Initials': 'F', 'LastName': 'Akiyama', 'Affiliation': 'Cancer Institute of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kurosumi', 'Affiliation': 'Kameda Medical Center, Chiba, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Shimomura', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Takao', 'Affiliation': 'Hyogo Cancer Center, Hyogo, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'NHO Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Tokuda', 'Affiliation': 'Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Inaji', 'Affiliation': 'Kaizuka City Hospital, Osaka, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Hamamatsu Oncology Center, Shizuoka, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohashi', 'Affiliation': 'Chuo University, Tokyo, Japan.'}]",Breast cancer research and treatment,['10.1007/s10549-020-06018-1']
3017,33258997,A hypoenergetic diet with decreased protein intake does not reduce lean body mass in trained females.,"PURPOSE
Increasing protein intake during energy restriction (ER) attenuates lean body mass (LBM) loss in trained males. However, whether this relationship exists in trained females is unknown. This study examined the impact of higher compared to lower protein intakes (35% versus 15% of energy intake) on body composition in trained females during 2 weeks of severe ER.
METHODS
Eighteen well-trained females completed a 1-week energy balanced diet (HD100), followed by a 2-week hypoenergetic (40% ER) diet (HD60). During HD60, participants consumed either a high protein (HP; 35% protein, 15% fat) or lower protein (CON; 15% protein, 35% fat) diet. Body composition, peak power, leg strength, sprint time, and anaerobic endurance were assessed at baseline, pre-HD60, and post-HD60.
RESULTS
Absolute protein intake was reduced during HD60 in the CON group (from 1.6 to 0.9 g·d·kgBM -1 ) and maintained in the HP group (~ 1.7 g·d·kgBM -1 ). CON and HP groups decreased body mass equally during HD60 (- 1.0 ± 1.1 kg; p = 0.026 and - 1.1 ± 0.7 kg; p = 0.002, respectively) and maintained LBM. There were no interactions between time point and dietary condition on exercise performance.
CONCLUSION
The preservation of LBM during HD60, irrespective of whether absolute protein intake is maintained or reduced, contrasts with findings in trained males. In trained females, the relationship between absolute protein intake and LBM change during ER warrants further investigation. Future recommendations for protein intake during ER should be expressed relative to body mass, not total energy intake, in trained females.",2020,"RESULTS
Absolute protein intake was reduced during HD60 in the CON group (from 1.6 to 0.9 g·d·kgBM -1 ) and maintained in the HP group (~ 1.7 g·d·kgBM -1 ).","['trained females during 2\xa0weeks of severe ER', 'Eighteen well-trained females completed a', 'trained males', 'trained females']","['CON and HP', 'energy restriction (ER', 'hypoenergetic diet with decreased protein intake', '1-week energy balanced diet (HD100), followed by a 2-week hypoenergetic (40% ER) diet (HD60']","['body composition', 'protein intakes', 'Body composition, peak power, leg strength, sprint time, and anaerobic endurance', 'exercise performance', 'lean body mass', 'Absolute protein intake']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}]",,0.0266973,"RESULTS
Absolute protein intake was reduced during HD60 in the CON group (from 1.6 to 0.9 g·d·kgBM -1 ) and maintained in the HP group (~ 1.7 g·d·kgBM -1 ).","[{'ForeName': 'Alice G', 'Initials': 'AG', 'LastName': 'Pearson', 'Affiliation': 'Department of Sport and Exercise Sciences, Durham University, Durham, UK.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Alexander', 'Affiliation': 'Physiology, Exercise and Nutrition Research Group, University of Stirling, Stirling, UK.'}, {'ForeName': 'Oliver C', 'Initials': 'OC', 'LastName': 'Witard', 'Affiliation': ""Centre of Human and Applied Physiological Research, King's College London, London, UK.""}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Coughlin', 'Affiliation': 'Physiology, Exercise and Nutrition Research Group, University of Stirling, Stirling, UK.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Tipton', 'Affiliation': 'Department of Sport and Exercise Sciences, Durham University, Durham, UK.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Walshe', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK. ian2.walshe@northumbria.ac.uk.'}]",European journal of applied physiology,['10.1007/s00421-020-04555-7']
3018,33258897,Antithrombotic therapy according to baseline bleeding risk in patients with atrial fibrillation undergoing percutaneous coronary intervention: applying the PRECISE-DAPT score in RE-DUAL PCI.,"AIMS
Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy. The RE-DUAL PCI trial demonstrated better safety with dual antithrombotic therapy (DAT: dabigatran 110 or 150 mg bid, clopidogrel or ticagrelor) compared to triple antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin). We explored the impact of baseline bleeding risk based on the PRECISE-DAPT score for decision-making regarding DAT vs. TAT.
METHODS AND RESULTS
A score ≥25 points qualified high bleeding-risk (HBR). Comparisons were made for the primary safety endpoint ISTH major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thromboembolic events, or unplanned revascularization, analyzed by time-to-event analysis. PRECISE-DAPT was available in 2,336/2,725 patients, and 37.9% were HBR. Compared to TAT, DAT with dabigatran 110 mg reduced bleeding risk both in non-HBR (HR 0.42, 95%CI, 0.31-0.57) and HBR (HR 0.70, 95%CI, 0.52-0.94), with a greater magnitude of benefit among non-HBR (Pint=0.02). DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08). Risk of ischaemic events was similar on DAT with dabigatran (both 110 and 150 mg) vs. TAT in non-HBR and HBR patients (Pint=0.45 and Pint=0.56, respectively).
CONCLUSIONS
PRECISE-DAPT score appeared useful to identify AF patients undergoing PCI at further increased risk of bleeding complications, and may help clinicians identifying the antithrombotic regimen intensity with the best benefit-risk ratio in an individual patient.",2020,"DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08).","['Patients with atrial fibrillation undergoing coronary intervention are at higher bleeding risk due to the concomitant need for oral anticoagulation and antiplatelet therapy', 'patients with atrial fibrillation undergoing percutaneous coronary intervention', '2,336/2,725 patients, and 37.9% were HBR']","['TAT, DAT with dabigatran', 'TAT', 'Antithrombotic therapy', 'antithrombotic therapy (TAT: warfarin, clopidogrel or ticagrelor, and aspirin', 'clopidogrel or ticagrelor', 'dual antithrombotic therapy (DAT: dabigatran']","['primary safety endpoint ISTH major or clinically relevant non-major bleeding, and the composite efficacy endpoint of death, thromboembolic events, or unplanned revascularization, analyzed by time-to-event analysis', 'bleeding risk', 'HBR', 'Risk of ischaemic events', 'bleeding-risk (HBR', 'risk of bleeding complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0466192,"DAT with dabigatran 150 mg vs. TAT reduced bleeding in non-HBR (HR 0.60, 95%CI, 0.45-0.80), with a trend toward less benefit in HBR patients (HR 0.92, 95%CI, 0.63-1.34, Pint=0.08).","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Department of Clinical and Experimental Medicine, Policlinic ""G Martino,"" University of Messina, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, an F-CRIN Network, DHU FIRE, Université Paris Diderot, INSERM U_1148 and Hôpital Bichat Assistance Publique, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Department of Cardiology, Division of Clinical Electrophysiology, Johann Wolfgang Goethe University, Frankfurt/Main, Germany.'}, {'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'mainanalytics GmbH, Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA.""}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvaa135']
3019,33258890,Effect of Cannabidiol and Δ9-Tetrahydrocannabinol on Driving Performance: A Randomized Clinical Trial.,"Importance
Cannabis use has been associated with increased crash risk, but the effect of cannabidiol (CBD) on driving is unclear.
Objective
To determine the driving impairment caused by vaporized cannabis containing Δ9-tetrahydrocannabinol (THC) and CBD.
Design, Setting, and Participants
A double-blind, within-participants, randomized clinical trial was conducted at the Faculty of Psychology and Neuroscience at Maastricht University in the Netherlands between May 20, 2019, and March 27, 2020. Participants (N = 26) were healthy occasional users of cannabis.
Interventions
Participants vaporized THC-dominant, CBD-dominant, THC/CBD-equivalent, and placebo cannabis. THC and CBD doses were 13.75 mg. Order of conditions was randomized and balanced.
Main Outcomes and Measures
The primary end point was standard deviation of lateral position (SDLP; a measure of lane weaving) during 100 km, on-road driving tests that commenced at 40 minutes and 240 minutes after cannabis consumption. At a calibrated blood alcohol concentration (BAC) of 0.02%, SDLP was increased relative to placebo by 1.12 cm, and at a calibrated BAC of 0.05%, SDLP was increased relative to placebo by 2.4 cm.
Results
Among 26 randomized participants (mean [SD] age, 23.2 [2.6] years; 16 women), 22 (85%) completed all 8 driving tests. At 40 to 100 minutes following consumption, the SDLP was 18.21 cm with CBD-dominant cannabis, 20.59 cm with THC-dominant cannabis, 21.09 cm with THC/CBD-equivalent cannabis, and 18.28 cm with placebo cannabis. SDLP was significantly increased by THC-dominant cannabis (+2.33 cm [95% CI, 0.80 to 3.86]; P < .001) and THC/CBD-equivalent cannabis (+2.83 cm [95% CI, 1.28 to 4.39]; P < .001) but not CBD-dominant cannabis (-0.05 cm [95% CI, -1.49 to 1.39]; P > .99), relative to placebo. At 240 to 300 minutes following consumption, the SDLP was 19.03 cm with CBD-dominant cannabis, 19.88 cm with THC-dominant cannabis, 20.59 cm with THC/CBD-equivalent cannabis, and 19.37 cm with placebo cannabis. The SDLP did not differ significantly in the CBD (-0.34 cm [95% CI, -1.77 to 1.10]; P > .99), THC (0.51 cm [95% CI, -1.01 to 2.02]; P > .99) or THC/CBD (1.22 cm [95% CI, -0.29 to 2.72]; P = .20) conditions, relative to placebo. Out of 188 test drives, 16 (8.5%) were terminated due to safety concerns.
Conclusions and Relevance
In a crossover clinical trial that assessed driving performance during on-road driving tests, the SDLP following vaporized THC-dominant and THC/CBD-equivalent cannabis compared with placebo was significantly greater at 40 to 100 minutes but not 240 to 300 minutes after vaporization; there were no significant differences between CBD-dominant cannabis and placebo. However, the effect size for CBD-dominant cannabis may not have excluded clinically important impairment, and the doses tested may not represent common usage.
Trial Registration
EU Clinical Trials Register: 2018-003945-40.",2020,"The SDLP did not differ significantly in the CBD (-0.34 cm [95% CI, -1.77 to 1.10]; P > .99), THC (0.51 cm [95% CI, -1.01 to 2.02]; P > .99) or THC/CBD (1.22 cm [95% CI, -0.29 to 2.72]; P = .20) conditions, relative to placebo.","['23.2 [2.6] years; 16 women), 22 (85%) completed all 8 driving tests', '26 randomized participants (mean [SD] age', 'Faculty of Psychology and Neuroscience at Maastricht University in the Netherlands between May 20, 2019, and March 27, 2020', 'Participants (N\u2009=\u200926) were healthy occasional users of cannabis']","['Interventions\n\n\nParticipants vaporized THC-dominant, CBD-dominant, THC/CBD-equivalent, and placebo cannabis', 'vaporized cannabis containing Δ9-tetrahydrocannabinol (THC) and CBD', 'Cannabidiol and Δ9-Tetrahydrocannabinol', 'placebo']","['calibrated blood alcohol concentration (BAC', 'THC/CBD-equivalent cannabis', 'THC-dominant cannabis', 'standard deviation of lateral position (SDLP; a measure of lane weaving', 'SDLP', 'Driving Performance', 'THC/CBD', 'CBD', 'THC']","[{'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0521114', 'cui_str': 'Infrequent'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",26.0,0.617725,"The SDLP did not differ significantly in the CBD (-0.34 cm [95% CI, -1.77 to 1.10]; P > .99), THC (0.51 cm [95% CI, -1.01 to 2.02]; P > .99) or THC/CBD (1.22 cm [95% CI, -0.29 to 2.72]; P = .20) conditions, relative to placebo.","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Arkell', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Vinckenbosch', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Kevin', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Eef L', 'Initials': 'EL', 'LastName': 'Theunissen', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Iain S', 'Initials': 'IS', 'LastName': 'McGregor', 'Affiliation': 'Lambert Initiative for Cannabinoid Therapeutics, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]",JAMA,['10.1001/jama.2020.21218']
3020,33258792,Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients.,"BACKGROUND
Negative symptoms are an important unmet treatment need for schizophrenia. This study is a preliminary, open, single-arm trial of a novel hybrid intervention called mobile-assisted cognitive behavioral therapy for negative symptoms (mCBTn).
OBJECTIVE
The primary aim was to test whether mCBTn was feasible and could reduce severity of the target mechanism, defeatist performance attitudes, which are associated with experiential negative symptoms and poor functioning in schizophrenia.
METHODS
Participants with schizophrenia or schizoaffective disorder (N=31) who met prospective criteria for persistent negative symptoms were enrolled. The blended intervention combines weekly in-person group therapy with a smartphone app called CBT2go. The app extended therapy group skills, including recovery goal setting, thought challenging, scheduling of pleasurable activities and social interactions, and pleasure-savoring interventions to modify defeatist attitudes and improve experiential negative symptoms.
RESULTS
Retention was excellent (87% at 18 weeks), and severity of defeatist attitudes and experiential negative symptoms declined significantly in the mCBTn intervention with large effect sizes.
CONCLUSIONS
The findings suggest that mCBTn is a feasible and potentially effective treatment for experiential negative symptoms, if confirmed in a larger randomized controlled trial. The findings also provide support for the defeatist attitude model of experiential negative symptoms and suggest that blended technology-supported interventions such as mCBTn can strengthen and shorten intensive psychosocial interventions for schizophrenia.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03179696; https://clinicaltrials.gov/ct2/show/NCT03179696.",2020,"RESULTS
Retention was excellent (87% at 18 weeks), and severity of defeatist attitudes and experiential negative symptoms declined significantly in the mCBTn intervention with large effect sizes.
","['Negative Symptoms', 'Participants with schizophrenia or schizoaffective disorder (N=31) who met prospective criteria for persistent negative symptoms were enrolled']","['mCBTn', 'blended intervention combines weekly in-person group therapy with a smartphone app called CBT2go', 'Mobile-Assisted Cognitive Behavioral Therapy', 'novel hybrid intervention called mobile-assisted cognitive behavioral therapy']","['severity of defeatist attitudes and experiential negative symptoms', 'Retention']","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.119763,"RESULTS
Retention was excellent (87% at 18 weeks), and severity of defeatist attitudes and experiential negative symptoms declined significantly in the mCBTn intervention with large effect sizes.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Granholm', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Holden', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Dwyer', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Mikhael', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Link', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA, United States.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Depp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, United States.'}]",JMIR mental health,['10.2196/24406']
3021,33258790,A Web-Based Mental Health Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The Springboard Trial): 12-Month Outcomes of a Randomized Controlled Trial.,"BACKGROUND
People with type 2 diabetes mellitus (T2DM) often experience mental health symptoms that exacerbate illness and increase mortality risk. Access to psychological support is low in people with T2DM. Detection of depression is variable in primary care and can be further hampered by mental health stigma. Electronic mental health (eMH) programs may provide an accessible, private, nonstigmatizing mental health solution for this group.
OBJECTIVE
This study aims to evaluate the efficacy over 12 months of follow-up of an eMH program (myCompass) for improving social and occupational functioning in a community sample of people with T2DM and self-reported mild-to-moderate depressive symptoms. myCompass is a fully automated and self-guided web-based public health program for people with depression or anxiety. The effects of myCompass on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior were also examined.
METHODS
Adults with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited via online advertisements, community organizations, and general practices. Screening, consent, and self-report questionnaires were administered online. Eligible participants were randomized to receive either myCompass (n=391) or an attention control generic health literacy program (Healthy Lifestyles; n=379) for 8 weeks. At baseline and at 3, 6, and 12 months postintervention, participants completed the Work and Social Adjustment Scale, the Patient Health Questionnaire-9 item, the Diabetes Distress Scale, the Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Glycosylated hemoglobin measurements were obtained at baseline and 6 and 12 months postintervention.
RESULTS
A total of 38.9% (304/780) of the trial participants completed all postintervention assessments. myCompass users logged in on an average of 6 times and completed an average of 0.29 modules. Healthy Lifestyles users logged in on an average of 4 times and completed an average of 1.37 modules. At baseline, the mean scores on several outcome measures, including the primary outcome of work and social functioning, were close to the normal range, despite a varied and extensive recruitment process. Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group. All participants reported equivalent improvements in depression anxiety, diabetes distress, diabetes self-management, and glycemic control across the trial.
CONCLUSIONS
The Healthy Lifestyles group reported higher ratings of social and occupational functioning than the myCompass group, but no differences were observed for any secondary outcome. Although these findings should be interpreted in light of the near-floor symptom scores at baseline, the trial yields important insights into how people with T2DM might be engaged in eMH programs and the challenges of focusing specifically on mental health. Several avenues emerge for continued investigation into how best to deal with the growing mental health burden in adults with T2DM.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry Number (ACTRN) 12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true.",2020,Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group.,"['adults with T2DM', 'community sample of people with T2DM and self-reported mild-to-moderate depressive symptoms', 'Eligible participants', 'Healthy Lifestyles users logged in on an average of 4 times and completed an average of 1.37 modules', 'people with T2DM', 'Adults With Type 2 Diabetes (The Springboard Trial', 'People with type 2 diabetes mellitus (T2DM', 'people with depression or anxiety', 'Adults with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited via online advertisements, community organizations, and general practices']","['eMH program (myCompass', 'Mental Health Intervention', 'myCompass (n=391) or an attention control generic health literacy program (Healthy Lifestyles', 'Electronic mental health (eMH) programs']","['work and social functioning', 'Glycosylated hemoglobin measurements', 'ratings of social and occupational functioning', 'depression anxiety, diabetes distress, diabetes self-management, and glycemic control', 'depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior', 'Work and Social Adjustment Scale, the Patient Health Questionnaire-9 item, the Diabetes Distress Scale, the Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management behavior'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0451485', 'cui_str': 'Social adjustment scale'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",,0.145501,Intention-to-treat analyses revealed slightly greater improvement at 12 months in work and social functioning for the Healthy Lifestyles group relative to the myCompass group.,"[{'ForeName': 'Peter Andrew', 'Initials': 'PA', 'LastName': 'Baldwin', 'Affiliation': 'Black Dog Institute, Randwick, Australia.'}, {'ForeName': 'Samineh', 'Initials': 'S', 'LastName': 'Sanatkar', 'Affiliation': 'Black Dog Institute, Randwick, Australia.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Clarke', 'Affiliation': 'Black Dog Institute, Randwick, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Fletcher', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Gunn', 'Affiliation': 'University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Wilhelm', 'Affiliation': 'UNSW Sydney, Randwick, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': 'UNSW Sydney, Randwick, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Zwar', 'Affiliation': 'UNSW Sydney, Randwick, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harris', 'Affiliation': 'UNSW Sydney, Randwick, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Lapsley', 'Affiliation': 'UNSW Sydney, Randwick, Australia.'}, {'ForeName': 'Dusan', 'Initials': 'D', 'LastName': 'Hadzi-Pavlovic', 'Affiliation': 'Black Dog Institute, Randwick, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Randwick, Australia.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Proudfoot', 'Affiliation': 'Black Dog Institute, Randwick, Australia.'}]",Journal of medical Internet research,['10.2196/16729']
3022,33258788,Mobile Texting and Lay Health Supporters to Improve Schizophrenia Care in a Resource-Poor Community in Rural China (LEAN Trial): Randomized Controlled Trial Extended Implementation.,"BACKGROUND
Schizophrenia is a severe and disabling condition that presents a dire health equity challenge. Our initial 6-month trial (previously reported) using mobile texting and lay health supporters, called LEAN, significantly improved medication adherence from 0.48 to 0.61 (adjusted mean 0.11, 95% CI 0.03 to 0.20, P=.007) for adults with schizophrenia living in a resource-poor village in rural China.
OBJECTIVE
We explored the effectiveness of our texting program in improving participants' medication adherence, functioning, and symptoms in an extended implementation of the intervention after its initial phase.
METHODS
In an approximated stepped-wedge wait-list design randomized controlled trial, 277 community-dwelling villagers with schizophrenia were assigned 1:1 in phase 1 into intervention and wait-list control groups. The intervention group received (1) lay health supporters (medication or care supervisors), (2) e-platform (mobile-texting reminders and education message) access, (3) a token gift for positive behavioral changes, and (4) integration with the existing government community-mental health program (the 686 Program) while the wait-listed control group initially only received the 686 Program. Subsequently (in the extended period), both groups received the LEAN intervention plus the 686 Program. The primary outcome was antipsychotic medication adherence (percentage of dosages taken over the past month assessed by unannounced home-based pill counts). The secondary outcomes were symptoms measured during visits to 686 Program psychiatrists using the Clinical Global Impression scale for schizophrenia and functioning measured by trained student assessors using the World Health Organization Disability Assessment Schedule 2.0. Other outcomes included data routinely collected in the 686 Program system (refill records, rehospitalization due to schizophrenia, death for any reason, suicide, wandering, and violent behaviors). We used intention-to-treat analysis and missing data were imputed. A generalized estimating equation model was used to assess program effects on antipsychotics medication adherence, symptoms, and functioning.
RESULTS
Antipsychotics medication adherence improved from 0.48 in the control period to 0.58 in the extended intervention period (adjusted mean difference 0.11, 95% CI 0.04 to 0.19; P=.004). We also noted an improvement in symptoms (adjusted mean difference -0.26, 95% CI -0.50 to -0.02; P=.04; Cohen d effect size 0.20) and a reduction in rehospitalization (0.37, 95% CI 0.18 to 0.76; P=.007; number-needed-to-treat 8.05, 95% CI 4.61 to 21.41). There was no improvement in functioning (adjusted mean difference 0.02, 95% CI -0.01 to 0.06; P=.18; Cohen d effect size 0.04).
CONCLUSIONS
In an extended implementation, our intervention featuring mobile texting messages and lay health workers in a resource-poor community setting was more effective than the 686 Program alone in improving medication adherence, improving symptoms, and reducing rehospitalization.
TRIAL REGISTRATION
Chinese Clinical Trial Registry; ChiCTR-ICR-15006053 https://tinyurl.com/y5hk8vng.",2020,"P=.007; number-needed-to-treat 8.05, 95% CI 4.61 to 21.41).","['277 community-dwelling villagers with schizophrenia', 'adults with schizophrenia living in a resource-poor village in rural China', 'Mobile Texting and Lay Health Supporters to Improve Schizophrenia Care in a Resource-Poor Community in Rural China (LEAN Trial']","['LEAN intervention', 'intervention group received (1) lay health supporters (medication or care supervisors), (2) e-platform (mobile-texting reminders and education message) access, (3) a token gift for positive behavioral changes, and (4) integration with the existing government community-mental health program (the 686 Program) while the wait-listed control group initially only received the 686 Program']","['functioning', 'rehospitalization', ""participants' medication adherence, functioning, and symptoms"", '686 Program system (refill records, rehospitalization due to schizophrenia, death for any reason, suicide, wandering, and violent behaviors', 'antipsychotic medication adherence (percentage of dosages taken over the past month assessed by unannounced home-based pill counts', 'antipsychotics medication adherence, symptoms, and functioning', 'Antipsychotics medication adherence', 'Clinical Global Impression scale for schizophrenia and functioning measured by trained student assessors using the World Health Organization Disability Assessment Schedule 2.0', 'medication adherence', 'medication adherence, improving symptoms, and reducing rehospitalization']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0016999', 'cui_str': 'Gamete intrafallopian transfer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C5191070', 'cui_str': '686'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0233569', 'cui_str': 'Wandering'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4304971', 'cui_str': 'WHODAS (World Health Organization Disability Assessment Schedule) 2.0'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",277.0,0.229379,"P=.007; number-needed-to-treat 8.05, 95% CI 4.61 to 21.41).","[{'ForeName': 'Yiyuan', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Shuiyuan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Xiangya School of Public Health, Central South University, Changsha, China.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gloyd', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Meijuan', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xinlei', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zichao', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Bofeng', 'Initials': 'B', 'LastName': 'Dai', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuantao', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dong Roman', 'Initials': 'DR', 'LastName': 'Xu', 'Affiliation': 'Acacia Lab for Health Systems Strengthening and Department of Health Management, School of Health Management, Southern Medical University, Guangzhou, China.'}]",Journal of medical Internet research,['10.2196/22631']
3023,33258784,A Patient-Centered Asthma Management Communication Intervention for Rural Latino Children: Protocol for a Waiting-List Randomized Controlled Trial.,"BACKGROUND
Rural Latino children with asthma suffer high rates of uncontrolled asthma symptoms, emergency department visits, and repeat hospitalizations. This vulnerable population must negotiate micro- and macrolevel challenges that impact asthma management, including language barriers, primary care access, parental time off from work, insurance coverage, distance from specialty sites, and documentation status. There are few proven interventions that address asthma management embedded within this unique context.
OBJECTIVE
Using a bio-ecological approach, we will determine the feasibility of a patient-centered collaborative program between rural Latino children with asthma and their families, school-based nursing programs, and primary care providers, facilitated by the use of a smartphone-based mobile app with a Spanish-language interface. We hypothesize that improving communication through a collaborative, patient-centered intervention will improve asthma management, empower the patient and family, decrease outcome disparities, and decrease direct and indirect costs.
METHODS
The specific aims of this study include the following: (1) Aim 1: produce and validate a Spanish translation of an existing asthma management app and evaluate its usability with Latino parents of children with asthma, (2) Aim 2: develop and evaluate a triadic, patient-centered asthma intervention preliminary protocol, facilitated by the bilingual mobile app validated in Aim 1, and (3) Aim 3: investigate the feasibility of the patient-centered asthma intervention from Aim 2 using a waiting-list randomized controlled trial (RCT) to investigate the effects of the intervention on school days missed and medication adherence.
RESULTS
Mobile app translation, initial usability testing, and app software refinement were completed in 2019. Analysis is in progress. Preliminary protocol testing is underway; we anticipate that the waiting-list RCT, using the refined protocol developed in Aim 2, will commence in fall 2020.
CONCLUSIONS
Tailored, technology-based solutions have the potential to successfully address issues affecting asthma management, including communication barriers, accessibility issues, medication adherence, and suboptimal technological interventions.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04633018; https://www.clinicaltrials.gov/ct2/show/NCT04633018.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/18977.",2020,"Tailored, technology-based solutions have the potential to successfully address issues affecting asthma management, including communication barriers, accessibility issues, medication adherence, and suboptimal technological interventions.
","['rural Latino children with asthma and their families, school-based nursing programs, and primary care providers, facilitated by the use of a smartphone-based mobile app with a Spanish-language interface', 'Latino parents of children with asthma', 'Rural Latino Children', 'Rural Latino children with asthma suffer high rates of uncontrolled asthma symptoms, emergency department visits, and repeat hospitalizations']","['Patient-Centered Asthma Management Communication Intervention', 'patient-centered asthma intervention', 'patient-centered collaborative program']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0899114,"Tailored, technology-based solutions have the potential to successfully address issues affecting asthma management, including communication barriers, accessibility issues, medication adherence, and suboptimal technological interventions.
","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Dawson', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Sue P', 'Initials': 'SP', 'LastName': 'Heiney', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'DeAnne Hilfinger', 'Initials': 'DH', 'LastName': 'Messias', 'Affiliation': 'College of Nursing, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Ownby', 'Affiliation': 'Augusta University, Augusta, GA, United States.'}]",JMIR research protocols,['10.2196/18977']
3024,33258782,Usage and Acceptability of the iBobbly App: Pilot Trial for Suicide Prevention in Aboriginal and Torres Strait Islander Youth.,"BACKGROUND
The proliferation of mental health apps purporting to target and improve psychological wellbeing is ever-growing and also concerning: Few apps have been rigorously evaluated, and, indeed, the safety of the vast majority of them has not been determined. Over 10,000 self-help apps exist but most are not used much after being downloaded. Gathering and analyzing usage data and the acceptability of apps are critical to inform consumers, researchers, and app developers.
OBJECTIVE
This paper presents pilot usage and acceptability data from the iBobbly suicide prevention app, an app distributed through a randomized controlled trial.
METHODS
Aboriginal and Torres Strait Islander participants from the Kimberley region of Western Australia completed a survey measuring their technology use in general (n=13), and data on their experiences with and views of the iBobbly app were also collected in semistructured interviews (n=13) and thematically analyzed. Finally, engagement with the app, such as the number of sessions completed and time spent on various acceptance-based therapeutic activities, was analyzed (n=18). Both groups were participants in the iBobbly app pilot randomized controlled trial (n=61) completed in 2015.
RESULTS
Regression analysis indicated that app use improved psychological outcomes, although only minimally, and effects were not significant. However, results of the thematic analysis indicated that the iBobbly app was deemed effective, acceptable, and culturally appropriate by those interviewed.
CONCLUSIONS
There is a scarcity of randomized controlled trials and eHealth interventions in Indigenous communities, while extremely high rates of psychological distress and suicide persist. In this environment, studies that can add evidence from mixed-methods approaches are important. While the regression analysis in this study did not indicate a significant effect of app use on psychological wellbeing, this was predictable considering the small sample size (n=18) and typically brief app use. The results on engagement with the iBobbly app were however positive. This study showed that Indigenous youth are early and frequent users of technology in general, and they regarded the iBobbly app to be culturally safe and of therapeutic value. Qualitative analyses demonstrated that iBobbly app use was associated with self-reported improvements in psychological wellbeing, mental health literacy, and reductions in shame. Importantly, participants reported that they would recommend other similar apps if available to their peers.",2020,"Qualitative analyses demonstrated that iBobbly app use was associated with self-reported improvements in psychological wellbeing, mental health literacy, and reductions in shame.","['Aboriginal and Torres', 'Strait Islander participants from the Kimberley region of Western Australia completed a survey measuring their technology use in general (n=13), and data on their experiences with and views of the iBobbly app were also collected in semistructured interviews (n=13) and thematically analyzed', 'Aboriginal and Torres Strait Islander Youth']",[],"['psychological wellbeing', 'psychological outcomes', 'psychological wellbeing, mental health literacy, and reductions in shame']","[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036938', 'cui_str': 'Shame'}]",61.0,0.122287,"Qualitative analyses demonstrated that iBobbly app use was associated with self-reported improvements in psychological wellbeing, mental health literacy, and reductions in shame.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tighe', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Shand', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'McKay', 'Affiliation': 'Tavistock and Portman NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Taylor-Jai', 'Initials': 'TJ', 'LastName': 'Mcalister', 'Affiliation': 'Centre for Health Informatics, Australian Institute of Health Innovation, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mackinnon', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, Sydney, Australia.'}]",JMIR mental health,['10.2196/14296']
3025,33258781,Capitated Telehealth Coaching Hospital Readmission Service in Australia: Pragmatic Controlled Evaluation.,"BACKGROUND
MonashWatch is a telehealth public hospital outreach pilot service as a component of the Government of Victoria's statewide redesign initiative called HealthLinks: Chronic Care. Rather than only paying for hospitalizations, projected funding is released earlier to hospitals to allow them to reduce hospitalization costs. MonashWatch introduced a web-based app, Patient Journey Record System, to assess the risk of the journeys of a cohort of patients identified as frequent admitters. Telecare guides call patients using the Patient Journey Record System to flag potential deterioration. Health coaches (nursing and allied health staff) triage risk and adapt care for individuals.
OBJECTIVE
The aim was a pragmatic controlled evaluation of the impact of MonashWatch on the primary outcome of bed days for acute nonsurgical admissions in the intention-to-treat group versus the usual care group. The secondary outcome was hospital admission rates. The net promoter score was used to gauge satisfaction.
METHODS
Patients were recruited into an intention-to-treat group, which included active telehealth and declined/lost/died groups, versus a systematically sampled (4:1) usual care group. A rolling sample of 250-300 active telehealth patients was maintained from December 23, 2016 to June 23, 2019. The outcome-mean bed days in intervention versus control-was adjusted using analysis of covariance for age, gender, admission type, and effective days active in MonashWatch. Time-series analysis tested for trends in change patterns.
RESULTS
MonashWatch recruited 1373 suitable patients who were allocated into the groups: usual care (n=293) and intention-to-treat (n=1080; active telehealth: 471/1080, 43.6%; declined: 485, 44.9%; lost to follow-up: 178 /1080, 10.7%; died: 8/1080, 0.7%). Admission frequency of intention-to-treat compared to that of the usual care group did not significantly improve (P=.05), with a small number of very frequent admitters in the intention-to-treat group. Age, MonashWatch effective days active, and treatment group independently predicted bed days. The analysis of covariance demonstrated a reduction in bed days of 1.14 (P<.001) in the intention-to-treat group compared with that in the usual care group, with 1236 bed days estimated savings. Both groups demonstrated regression-to-the-mean. The downward trend in improved bed days was significantly greater (P<.001) in the intention-to-treat group (Sen slope -406) than in the usual care group (Sen slope -104). The net promoter score was 95% in the active telehealth group compared with typical hospital scores of 77%.
CONCLUSIONS
Clinically and statistically meaningful reductions in acute hospital bed days in the intention-to-treat group when compared to that of the usual care group were demonstrated (P<.001), although admission frequency was unchanged with more short stay admissions in the intention-to-treat group. Nonrandomized control selection was a limitation. Nonetheless, MonashWatch was successful in the context of the HealthLinks: Chronic Care capitation initiative and is expanding.",2020,"The analysis of covariance demonstrated a reduction in bed days of 1.14 (P<.001) in the intention-to-treat group compared with that in the usual care group, with 1236 bed days estimated savings.","['Health coaches (nursing and allied health staff) triage risk and adapt care for individuals', 'MonashWatch recruited 1373 suitable patients who were allocated into the groups', 'Australia', 'A rolling sample of 250-300 active telehealth patients was maintained from December 23, 2016 to June 23, 2019', 'Patients were recruited into an intention-to-treat group, which included active telehealth and declined/lost/died groups, versus a systematically sampled (4:1) usual care group']","['usual care', 'MonashWatch']","['admission frequency', 'net promoter score', 'hospital admission rates', 'Admission frequency of intention-to-treat']","[{'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",[],"[{'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",1373.0,0.0898917,"The analysis of covariance demonstrated a reduction in bed days of 1.14 (P<.001) in the intention-to-treat group compared with that in the usual care group, with 1236 bed days estimated savings.","[{'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Monash Health Faculty of Medicine, Nursing and Health Sciences, Monash University, Clayton, Australia.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Hinkley', 'Affiliation': 'Community Health, Monash Health, Dandenong, Victoria, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Stockman', 'Affiliation': 'Community Health, Monash Health, Dandenong, Victoria, Australia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Northern Health, Northern Hospital, Epping, Victoria, Australia.'}]",Journal of medical Internet research,['10.2196/18046']
3026,33258776,A Mobile- and Web-Based Health Intervention Program for Diabetes and Prediabetes Self-Management (BetaMe/Melon): Process Evaluation Following a Randomized Controlled Trial.,"BACKGROUND
Technology-assisted self-management programs are increasingly recommended to patients with long-term conditions such as diabetes. However, there are a number of personal and external factors that affect patients' abilities to engage with and effectively utilize such programs. A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the study period.
OBJECTIVE
This process evaluation aimed to examine the utilization patterns of BetaMe/Melon, identify which components participants found most (and least) useful, and identify areas of future improvement.
METHODS
Process evaluation data were collected for intervention arm participants from 3 sources: (1) the mobile/web platform (to identify key usage patterns over the 16-week core program), (2) an online questionnaire completed during the final study assessment, and (3) interviews conducted with a subset of participants following the study period. Participants were classified as ""actively engaged"" if any usage data was recorded for the participant (in any week), and patterns were reported by age, gender, ethnicity, and diabetes/prediabetes status. The online questionnaire asked participants about the usefulness of the program and whether they would recommend BetaMe/Melon to others according to a 5-point Likert Scale. Of 23 invited participants, 18 participated in a digitally recorded, semistructured telephone interview. Interview data were thematically analyzed.
RESULTS
Out of the 215 participants, 198 (92%) received an initial health coaching session, and 160 (74%) were actively engaged with the program at some point during the 16-week core program. Engagement varied by demographic, with women, younger participants, and ethnic majority populations having higher rates of engagement. Usage steadily declined from 50% at Week 0 to 23% at Week 15. Participants ranked component usefulness as education resources (63.7%), health coaches (59.2%), goal tracking (48.8%), and online peer support (42.1%). Although 53% agreed that the program was easy to use, 64% would recommend the program to others. Interview participants found BetaMe/Melon useful overall, with most identifying beneficial outcomes such as increased knowledge, behavioral changes, and weight loss. Barriers to engagement were program functionality, internet connectivity, incomplete delivery of all program components, and participant motivation. Participants suggested a range of improvements to the BetaMe/Melon program.
CONCLUSIONS
The program was generally well received by participants; active engagement was initially high, although it declined steadily. Maintaining participant engagement over time, individualizing programs, and addressing technical barriers are important to maximize potential health benefits from online diabetes self-management programs.
TRIAL REGISTRATION
Australian New Zealand Clinical Trial Registry ACTRN12617000549325; https://tinyurl.com/y622b27q.",2020,"A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the study period.
","['Process evaluation data were collected for intervention arm participants from 3 sources: (1) the mobile/web platform (to identify key usage patterns over the 16-week core program), (2) an online questionnaire completed during the final study assessment, and (3) interviews conducted with a subset of participants following the study period', 'Of 23 invited participants, 18 participated in a digitally recorded, semistructured telephone interview', 'Diabetes and Prediabetes Self-Management', 'Participants were classified as ""actively engaged"" if any usage data was recorded for the participant (in any week), and patterns were reported by age, gender, ethnicity, and diabetes/prediabetes status', 'patients with long-term conditions such as diabetes', '215 participants, 198 (92%) received an']","['multi-modal online program', 'initial health coaching session', 'Mobile- and Web-Based Health Intervention Program']","['Usage steadily', 'knowledge, behavioral changes, and weight loss']","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4709308', 'cui_str': '215'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",215.0,0.054981,"A randomized controlled trial of a multi-modal online program for diabetes self-management (BetaMe/Melon) was conducted in a primary care setting, and a process evaluation was completed at the end of the study period.
","[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Signal', 'Affiliation': 'Department of Public Health, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'McLeod', 'Affiliation': 'Department of Public Health, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Stanley', 'Affiliation': ""Biostatistical Group, Dean's Department, University of Otago Wellington, Wellington, New Zealand.""}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Stairmand', 'Affiliation': 'Department of Public Health, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Sukumaran', 'Affiliation': 'School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Donna-Marie', 'Initials': 'DM', 'LastName': 'Thompson', 'Affiliation': 'Department of Public Health, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Henderson', 'Affiliation': 'Department of Public Health, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Davies', 'Affiliation': 'Kokiri Marae, Wellington, New Zealand.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Krebs', 'Affiliation': 'Department of Medicine, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dowell', 'Affiliation': 'Department of Primary Health Care and General Practice, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Grainger', 'Affiliation': 'Department of Medicine, University of Otago Wellington, Wellington, New Zealand.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Sarfati', 'Affiliation': 'Department of Public Health, University of Otago Wellington, Wellington, New Zealand.'}]",Journal of medical Internet research,['10.2196/19150']
3027,33258774,Super High-Pressure Balloon versus Scoring Balloon to Prepare Severely Calcified Coronary Lesions: The ISAR-CALC Randomized Trial.,"AIMS
The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied. We sought to compare stent expansion following preparation of severely calcified coronary lesions with either super high-pressure balloon or scoring balloon.
METHODS AND RESULTS
In this randomized, open-label trial 74 patients with severely calcified coronary lesions were enrolled at 5 centers in Germany and Switzerland. After unsuccessful lesion preparation with standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomized to pre-dilation with either super high-pressure balloon or scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success. OCT data after DES implantation was available for 70 patients (94.6%). Lesion preparation with super high-pressure balloon versus scoring balloon led to comparable stent expansion index (0.72±0.12 versus 0.68±0.13; p=0.22). Compared with scoring balloon, super high-pressure balloon increased minimum lumen diameter (2.83±0.34 mm versus 2.65±0.36 mm; p=0.03) and reduced diameter stenosis (11.6±4.8% versus 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% versus 97.3%; p>0.99). Strategy success (91.9% versus 83.8%; p=0.48) and procedural success (100% versus 89.2%; p=0.12) were numerically more frequent with super high-pressure balloon versus scoring balloon.
CONCLUSIONS
In patients with severely calcified coronary artery lesions, preparation with super high-pressure balloon versus scoring balloon was associated with comparable stent expansion on intravascular imaging and a signal toward improved angiographic performance.",2020,"Strategy success (91.9% versus 83.8%; p=0.48) and procedural success (100% versus 89.2%; p=0.12) were numerically more frequent with super high-pressure balloon versus scoring balloon.
","['74 patients with severely calcified coronary lesions were enrolled at 5 centers in Germany and Switzerland', 'Severely Calcified Coronary Lesions', 'patients with severely calcified coronary artery lesions, preparation with']","['Super High-Pressure Balloon versus Scoring Balloon', 'super high-pressure balloon versus scoring balloon', 'pre-dilation with either super high-pressure balloon or scoring balloon before drug-eluting stent (DES) implantation', 'super high-pressure balloon or scoring balloon', 'balloon-based techniques', 'standard non-compliant balloon']","['angiographic success', 'angiographic performance', 'minimum lumen diameter', 'stent expansion index', 'Strategy success', 'procedural success', 'stent expansion index as assessed by optical coherence tomography (OCT', 'reduced diameter stenosis', 'angiographic, strategy and procedural success', 'OCT data']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C1451765', 'cui_str': 'SNAP25 protein, human'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant'}]","[{'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]",,0.0992854,"Strategy success (91.9% versus 83.8%; p=0.48) and procedural success (100% versus 89.2%; p=0.12) were numerically more frequent with super high-pressure balloon versus scoring balloon.
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Rheude', 'Affiliation': 'Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Rai', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': ''}, {'ForeName': 'Abdelhakim', 'Initials': 'A', 'LastName': 'Allali', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}, {'ForeName': 'Dmitriy S', 'Initials': 'DS', 'LastName': 'Sulimov', 'Affiliation': ''}, {'ForeName': 'Kambis', 'Initials': 'K', 'LastName': 'Mashayekhi', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Ayoub', 'Affiliation': ''}, {'ForeName': 'Florim', 'Initials': 'F', 'LastName': 'Cuculi', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bossard', 'Affiliation': ''}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': ''}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': ''}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': ''}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Fusaro', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Joner', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-01000']
3028,33258686,Translating the REACH OUT dementia caregiver intervention into a primary care setting: a pilot study.,"OBJECTIVE
The current study translated the Resources for Enhancing Alzheimer's Caregiver Health: Offering Useful Treatments (REACH OUT), a skills-building stress and burden intervention, for the primary care setting and pilot the resulting intervention.
METHODS
The 16-week intervention consisted of a combination of clinic-based group and one-on-one sessions offered within a medical home, geriatrics clinic. A quasi-experimental pre- and post-test study design without a control group tested the resulting intervention. Semi-structured qualitative exit interviews evaluated program satisfaction.
RESULTS
Twenty-five caregivers participated in one of four intervention groups; 21 caregivers completed the intervention (attended at least five of six group sessions). Caregiver burden on standardized assessments was significantly reduced between pre- and post-intervention, specifically for physical/emotional strain and caregiving uncertainty. Significant reductions were found in the frequency of reported disruptive behaviors; increased caregiver confidence in handling behavior problem frequency, depressive symptoms, disruptive behaviors, and memory-related problems; and decreased bother with respect to behavioral problem frequency and care recipient depression. Program satisfaction was high.
CONCLUSION
This work suggests that the REACH OUT program can be successfully modified for use within a primary-care medical home setting.",2020,"Significant reductions were found in the frequency of reported disruptive behaviors; increased caregiver confidence in handling behavior problem frequency, depressive symptoms, disruptive behaviors, and memory-related problems; and decreased bother with respect to behavioral problem frequency and care recipient depression.",['Twenty-five caregivers participated in one of four intervention groups; 21 caregivers'],"['combination of clinic-based group and one-on-one sessions offered within a medical home, geriatrics clinic']","['Program satisfaction', 'Caregiver burden on standardized assessments', 'frequency of reported disruptive behaviors; increased caregiver confidence in handling behavior problem frequency, depressive symptoms, disruptive behaviors, and memory-related problems', 'behavioral problem frequency and care recipient depression']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2713310', 'cui_str': 'Medical Home'}, {'cui': 'C0555968', 'cui_str': 'Elderly assessment clinic'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0018578', 'cui_str': 'Handling (Psychology)'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",25.0,0.0213498,"Significant reductions were found in the frequency of reported disruptive behaviors; increased caregiver confidence in handling behavior problem frequency, depressive symptoms, disruptive behaviors, and memory-related problems; and decreased bother with respect to behavioral problem frequency and care recipient depression.","[{'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Sikora Kessler', 'Affiliation': 'College of Public Health, Department of Health Promotion, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Mock', 'Affiliation': 'Brown University, Department of Medicine, Providence, Rhode Island, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Hendricks', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, Gerontology, and Palliative Medicine, University of Nebraska Medical Center, College of Medicine, Omaha, Nebraska, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Robbins', 'Affiliation': 'College of Nursing, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Harpriya', 'Initials': 'H', 'LastName': 'Kaur', 'Affiliation': 'College of Public Health, Department of Epidemiology, University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Jane F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, Gerontology, and Palliative Medicine, University of Nebraska Medical Center, College of Medicine, Omaha, Nebraska, USA.'}, {'ForeName': 'Louis D', 'Initials': 'LD', 'LastName': 'Burgio', 'Affiliation': 'The University of Alabama and Burgio Geriatric Consulting, Tuscaloosa, Alabama, USA.'}]",Aging & mental health,['10.1080/13607863.2020.1850638']
3029,33258654,Mixed-State Entanglement from Local Randomized Measurements.,"We propose a method for detecting bipartite entanglement in a many-body mixed state based on estimating moments of the partially transposed density matrix. The estimates are obtained by performing local random measurements on the state, followed by postprocessing using the classical shadows framework. Our method can be applied to any quantum system with single-qubit control. We provide a detailed analysis of the required number of experimental runs, and demonstrate the protocol using existing experimental data [Brydges et al., Science 364, 260 (2019)SCIEAS0036-807510.1126/science.aau4963].",2020,We propose a method for detecting bipartite entanglement in a many-body mixed state based on estimating moments of the partially transposed density matrix.,[],[],[],[],[],[],,0.0291137,We propose a method for detecting bipartite entanglement in a many-body mixed state based on estimating moments of the partially transposed density matrix.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Elben', 'Affiliation': 'Center for Quantum Physics, University of Innsbruck, Innsbruck A-6020, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kueng', 'Affiliation': 'Institute for Integrated Circuits, Johannes Kepler University Linz, Altenbergerstrasse 69, 4040 Linz, Austria.'}, {'ForeName': 'Hsin-Yuan Robert', 'Initials': 'HR', 'LastName': 'Huang', 'Affiliation': 'Institute for Quantum Information and Matter, Caltech, Pasadena, California 91125, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'van Bijnen', 'Affiliation': 'Center for Quantum Physics, University of Innsbruck, Innsbruck A-6020, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kokail', 'Affiliation': 'Center for Quantum Physics, University of Innsbruck, Innsbruck A-6020, Austria.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Dalmonte', 'Affiliation': 'The Abdus Salam International Center for Theoretical Physics, Strada Costiera 11, 34151 Trieste, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Calabrese', 'Affiliation': 'The Abdus Salam International Center for Theoretical Physics, Strada Costiera 11, 34151 Trieste, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kraus', 'Affiliation': 'Institute for Theoretical Physics, University of Innsbruck, A6020 Innsbruck, Austria.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Preskill', 'Affiliation': 'Institute for Quantum Information and Matter, Caltech, Pasadena, California 91125, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zoller', 'Affiliation': 'Center for Quantum Physics, University of Innsbruck, Innsbruck A-6020, Austria.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Vermersch', 'Affiliation': 'Center for Quantum Physics, University of Innsbruck, Innsbruck A-6020, Austria.'}]",Physical review letters,['10.1103/PhysRevLett.125.200501']
3030,33258566,Role of stent oversizing in patients undergoing primary percutaneous coronary intervention. An open-labeled randomized controlled trial.,"BACKGROUND
In patients with ST-segment-elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PPCI) is the treatment of choice. Stent undersizing might occur due to catecholamine release and coronary spasm. Although routine oversizing has been promising in several investigations, it has never been tested in randomized clinical trials. In this single-center open-label randomized clinical trial, we evaluated the role of stent oversizing in PPCI.
METHODS
Candidates for PPCI were randomly divided into oversized and non-oversized groups. In the oversized group, the stent was oversized by 10% according to the mean lumen diameter, retrieved from the quantitative coronary analysis. Primary composite endpoints were defined as the occurrence of complete total ST-segment (STR)resolution and postprocedural thrombolysis in myocardial infarction (TIMI) flow grade III.
RESULTS
The study population was comprised of 122 patients, allocated to the oversized group (n = 61) and the non-oversized group (n = 61). There was no significant difference between the 2 groups regarding the final TIMI flow grade. Complete STR was marginally more favorable in the non-oversized group (56.05 ± 55.12 vs 64.64 ± 23.28; P = 0.056). The troponin ratio, CK-MB ratio, and 6-month follow up outcome-defined as target lesion revascularization, heart failure, and cardiovascular death-were comparable between the 2 groups.
CONCLUSIONS
Our study showed that routine oversizing in patients undergoing PPCI had no benefit regarding ST-segment resolution and the final TIMI flow, as well as hard cardiac events, during the follow-up.",2020,Complete STR was marginally more favorable in the non-oversized group (56.05 ± 55.12 vs 64.64 ± 23.28; P = 0.056).,"['122 patients, allocated to the oversized group (n = 61) and the non-oversized group (n = 61', 'Candidates for PPCI', 'patients with ST-segment-elevation myocardial infarction (STEMI), primary', 'patients undergoing primary percutaneous coronary intervention']","['stent oversizing', 'percutaneous coronary intervention (PPCI']","['Complete STR', 'final TIMI flow grade', 'troponin ratio, CK-MB ratio, and 6-month follow up outcome-defined as target lesion revascularization, heart failure, and cardiovascular death', 'occurrence of complete total ST-segment (STR)resolution and postprocedural thrombolysis in myocardial infarction (TIMI) flow grade III']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1519302', 'cui_str': 'Short Tandem Repeats'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}]",122.0,0.0325245,Complete STR was marginally more favorable in the non-oversized group (56.05 ± 55.12 vs 64.64 ± 23.28; P = 0.056).,"[{'ForeName': 'Seyed A', 'Initials': 'SA', 'LastName': 'Banifatemeh', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parham', 'Initials': 'P', 'LastName': 'Sadeghipour', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad J', 'Initials': 'MJ', 'LastName': 'Alemzadeh-Ansari', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Fakhrabadi', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshte', 'Initials': 'F', 'LastName': 'Zolfaghari', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Mohebbi', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kiani', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Shakerian', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rashidinejad', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hosseini', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ata', 'Initials': 'A', 'LastName': 'Firouzi', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical, and Research Center, Iran University of Medical Sciences, Tehran, Iran - atafirouzi@yahoo.com.'}]",Minerva cardioangiologica,['10.23736/S0026-4725.20.05396-7']
3031,33258534,Randomized clinical trial of combined therapy with oral α-lipoic acid and NB-UVB for non-segmental stable vitiligo.,"BACKGROUND
Vitiligo is associated with oxidant stress and α-lipoic acid (ALA) is an antioxidative agent.
OBJECTIVE
To evaluate the efficacy and safety of oral ALA in combination with NB-UVB phototherapy on non-segmental stable vitiligo.
METHODS
The prospective, multi-center, parallel controlled, double-blind randomized clinical trial was conducted from 2012 to 2014, in 7 comprehensive tertiary hospitals in China. The patients were randomized into oral ALA group or placebo group at a dose of 300 mg daily for 6 months. All of them received NB-UVB phototherapy 3 times weekly. The re-pigmentation rate was evaluated by 4-point grading scale of improvement: >98%, 50%-98%, 10%-49%, <10%.
RESULTS
A total of 133 patients were enrolled in the study, including 72 cases in treatment group and 61 cases in control group. In treatment group, 2.04% (1/49) patients achieved ≥50% improvement at 1-month after enrollment (M1), and the percentage of patients increased to 8.51% (4/47), 14.0% (6/43) and 37.8% (14/37) at M2, M3 and M6, respectively. In control group, the percentages were similar at all timepoints. No significant difference was seen between the two groups (P>0.05). For elder patients, younger patients, male or female, no significant differences were found between treatment group and control group at all timepoints.
CONCLUSIONS
ALA did not show additional benefit to NB-UVB therapy in the treatment of non-segmental stable vitiligo. More studies should be done to identify other protocols of ALA or other types of antioxidants for stable vitiligo. This article is protected by copyright. All rights reserved.",2020,ALA did not show additional benefit to NB-UVB therapy in the treatment of non-segmental stable vitiligo.,"['non-segmental stable vitiligo', '2012 to 2014, in 7 comprehensive tertiary hospitals in China', '133 patients were enrolled in the study, including 72 cases in treatment group and 61 cases in control group']","['placebo', 'oral ALA', 'NB-UVB phototherapy', 'NB-UVB therapy', 'ALA', 'combined therapy with oral α-lipoic acid and NB-UVB']","['re-pigmentation rate', 'efficacy and safety']","[{'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",133.0,0.112099,ALA did not show additional benefit to NB-UVB therapy in the treatment of non-segmental stable vitiligo.,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University.'}, {'ForeName': 'Xiuhao', 'Initials': 'X', 'LastName': 'Guan', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University.'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Dermatology, People's Hospital of Peking University.""}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Institute of Dermatology of Chinese Academy of Medical Sciences.'}, {'ForeName': 'Hongguang', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Department of Dermatology, the Affiliated Hospital of Guizhou Medical University.'}, {'ForeName': 'Zhirong', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Department of Dermatology, Xin-Hua Hospital Affiliated to Shanghai Jiao Tong University.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Xiangya Hospital of Central South University.'}, {'ForeName': 'Fanqin', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Department of Dermatology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University.'}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Gao', 'Affiliation': 'Department of Dermatology, The First Hospital of China Medical University.'}]",Dermatologic therapy,['10.1111/dth.14610']
3032,33258531,To Trial or Not to Trial Before Spinal Cord Stimulation for Chronic Neuropathic Pain: The Patients' View From the TRIAL-STIM Randomized Controlled Trial.,"Objectives Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL-STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL-STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not. Materials and Methods We interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow-up). Interviews were undertaken by telephone and audio-recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one-stage (no screening trial) versus two-stage (screening trial) implant procedure on a five-point Likert scale, before and after implantation. Results Emergent themes favoured the option for a one-stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having ""loose wires"" in the two-stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one-stage procedure without a screening trial. Conclusions Our findings indicate an overwhelming preference among participants for a one-stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL-STIM RCT results.",2020,Participants' rated preferences show similar support for a one-stage procedure without a screening trial.,"['31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow-up', 'chronic neuropathic pain']","['Objectives Spinal cord stimulation (SCS', 'Spinal Cord Stimulation']","['Chronic Neuropathic Pain', 'saving time (off work, in hospital, attending appointments), avoiding the worry about having ""loose wires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}]","[{'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205407', 'cui_str': 'Loose'}, {'cui': 'C0005978', 'cui_str': 'Bone wire'}]",31.0,0.332873,Participants' rated preferences show similar support for a one-stage procedure without a screening trial.,"[{'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Chadwick', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'McNaughton', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Baranidharan', 'Affiliation': 'Leeds Neuromodulation Centre, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, UK.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Brookes', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Rui V', 'Initials': 'RV', 'LastName': 'Duarte', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Earle', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, UK.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Gulve', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Houten', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Griffiths', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thomson', 'Affiliation': 'Department of Anaesthesia, Basildon and Thurrock University Hospitals, Basildon, UK.'}, {'ForeName': 'Harbinder', 'Initials': 'H', 'LastName': 'Sandhu', 'Affiliation': 'Warwick Medical School, University of Warwick, Warwick, UK.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13316']
3033,33258495,Preoperative decolonization and periprosthetic joint infections - A randomized controlled trial with 2-year follow-up.,"Preoperative decolonization, especially of Staphylococcus aureus carriers, has been proposed to reduce periprosthetic joint infections (PJI), but evidence-based consensus is still lacking and data on long term outcome is scarce. In a previous randomized, single-blinded trial, decolonization produced no significant reduction of surgical site infections in overall elective orthopaedic surgery at 3-month follow-up. A two-year follow-up was then performed to specifically detect the impact of decolonization on delayed-onset PJI (3 to 24 months after surgery). Between November 2014 and September 2017, 613 of 1,318 recruited patients underwent prosthetic surgery. Individuals were allocated into either the S. aureus carrier group (34%, 207 of 613 patients) or the non-carrier group (406 of 613 patients), according to nasal swab screening results. Both groups were then randomized into intervention and control arms. In the S. aureus group, intervention consisted of daily chlorhexidine showers and application of mupirocin nasal ointment twice a day during 5 days before surgery. In non-carriers, only chlorhexidine showers were prescribed. Sample size calculation was based on the initial trial for overall and not for the prosthetic surgery group. No PJI was found at two years in either the carrier or in the non-carrier group. Therefore, no definite conclusion about efficacy of preoperative decolonization to reduce PJI can be drawn. PJI proportions in this study were lower than described in the literature (mostly around 0.3%). Despite the insufficient sample size, this trial is the largest randomized trial on decolonization with a long-term follow-up, and results may be helpful for future meta-analyses. This article is protected by copyright. All rights reserved.",2020,"In a previous randomized, single-blinded trial, decolonization produced no significant reduction of surgical site infections in overall elective orthopaedic surgery at 3-month follow-up.","['Between November 2014 and September 2017, 613 of 1,318 recruited patients underwent']","['chlorhexidine', 'prosthetic surgery', 'chlorhexidine showers and application of mupirocin nasal ointment']","['surgical site infections', 'PJI proportions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0541748', 'cui_str': 'Shower'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1241186', 'cui_str': 'Mupirocin Nasal Ointment [Bactroban]'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0157749', 'cui_str': 'Arthropathy associated with infection'}]",1318.0,0.0873429,"In a previous randomized, single-blinded trial, decolonization produced no significant reduction of surgical site infections in overall elective orthopaedic surgery at 3-month follow-up.","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Rohrer', 'Affiliation': 'Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland.'}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Wendt', 'Affiliation': 'Hautärzte Hamburg, 22457, Hamburg, Germany.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Noetzli', 'Affiliation': 'University of Bern, Switzerland.'}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Risch', 'Affiliation': 'University of Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bodmer', 'Affiliation': 'Labormedizinisches Zentrum Dr Risch, Microbiology, Koeniz, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottagnoud', 'Affiliation': 'Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Hermann', 'Affiliation': 'Stiftung Lindenhof, Swiss Institute for Translational and Entrepreneurial Medicine, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Limacher', 'Affiliation': 'CTU Bern, University of Bern, Switzerland.'}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Gahl', 'Affiliation': 'CTU Bern, University of Bern, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Bruegger', 'Affiliation': 'Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24916']
3034,33258492,Effects of preliminary class membership on subsequent stimulus equivalence class formation.,"The present study examined the effects of including stimuli previously trained as members of functional classes or equivalence classes on subsequent equivalence class formation, and isolated the effects of preliminary training from those of the acquired function stimuli. Fifty-six adults were assigned to 1 of 5 conditions. The control group (CONT) received no preliminary training prior to the terminal phase. Participants in the other 4 groups learned two 3-member functional classes and two 3-member equivalence classes during the preliminary phase. The terminal equivalence phase trained two 5-member classes (A → B → C → D → E) comprising abstract forms; the C stimuli in the terminal phase were (a) from the preliminary functional classes for 1 group (ACQ-F), (b) from the preliminary equivalence classes for the second experimental group (ACQ-E), (c) pictures of everyday objects for the picture control group (PIC), and (d) novel, unfamiliar stimuli for the preliminary training control group (PRE-CONT). Class formation yields were 100% in the PIC condition and 11% in the CONT condition; however, low yields in the PRE-CONT, ACQ-F, and ACQ-E conditions were unexpected, suggesting that procedural variables in preliminary training account for more of the subsequent effects on class formation than the stimulus control properties of the acquired function stimuli.",2020,"The present study examined the effects of including stimuli previously trained as members of functional classes or equivalence classes on subsequent equivalence class formation, and isolated the effects of preliminary training from those of the acquired function stimuli.",['Fifty-six adults'],"['preliminary class membership', 'second experimental group (ACQ-E), (c) pictures of everyday objects for the picture control group (PIC), and (d) novel, unfamiliar stimuli for the preliminary training control group (PRE-CONT', 'control group (CONT) received no preliminary training prior to the terminal phase']","['subsequent stimulus equivalence class formation', 'Class formation yields']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",56.0,0.0121485,"The present study examined the effects of including stimuli previously trained as members of functional classes or equivalence classes on subsequent equivalence class formation, and isolated the effects of preliminary training from those of the acquired function stimuli.","[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'McPheters', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University.'}, {'ForeName': 'Kenneth F', 'Initials': 'KF', 'LastName': 'Reeve', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Fienup', 'Affiliation': 'Department of Health & Behavior Studies, Teachers College, Columbia University.'}, {'ForeName': 'Sharon A', 'Initials': 'SA', 'LastName': 'Reeve', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'DeBar', 'Affiliation': 'Department of Applied Behavior Analysis, Caldwell University.'}]",Journal of the experimental analysis of behavior,['10.1002/jeab.650']
3035,33258422,African American Recruitment in Early Heart Failure Palliative Care Trials: Outcomes and Comparison With the ENABLE CHF-PC Randomized Trial.,"BACKGROUND
Palliative care trial recruitment of African Americans (AAs) is a formidable research challenge.
OBJECTIVES
Examine AA clinical trial recruitment and enrollment in a palliative care randomized controlled trial (RCT) for heart failure (HF) patients and compare patient baseline characteristics to other HF palliative care RCTs.
METHODS
This is a descriptive analysis the ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends: Comprehensive Heartcare for Patients and Caregivers) RCT using bivariate statistics to compare racial and patient characteristics and differences through recruitment stages. We then compared the baseline sample characteristics among three palliative HF trials.
RESULTS
Of 785 patients screened, 566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226). African Americans were more likely to consent than Caucasians (55%; P FDR = .001), were younger (62.7 + 8; P FDR = .03), had a lower ejection fraction (39.1 + 15.4; P FDR = .03), were more likely to be single ( P FDR = .001), and lack an advanced directive (16.4%; P FDR < .001). AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more ""denial"" coping strategies (0.8 + 1; P FDR = .001). Compared to two recent HF RCTs, the ENABLE CHF-PC sample had a higher proportion of AAs and higher baseline KCCQ clinical summary scores.
CONCLUSION
ENABLE CHF-PC has the highest reported recruitment rate and proportion of AAs in a palliative clinical trial to date. Community-based recruitment partnerships, recruiter training, ongoing communication with recruiters and clinician co-investigators, and recruiter racial concordance likely contributed to successful recruitment of AAs. These important insights provide guidance for design of future HF palliative RCTs.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02505425.",2020,"AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more ""denial"" coping strategies (0.8 + 1; P FDR = .001).","['Patients and Caregivers', 'African Americans', '785 patients screened', '566 eligible patients with NYHA classification III-IV were approached; 461 were enrolled and 415 randomized (AA = 226', 'African Americans (AAs']",['RCT'],"['lower ejection fraction', 'care coordination', 'denial"" coping strategies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1275491', 'cui_str': 'New York Heart Association Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0011317', 'cui_str': 'Denial - mental defense mechanism'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",566.0,0.290085,"AAs reported higher goal setting (3.3 + 1.3; P FDR = .007), care coordination (2.8 + 1.3; P FDR = .001) and used more ""denial"" coping strategies (0.8 + 1; P FDR = .001).","[{'ForeName': 'Macy L', 'Initials': 'ML', 'LastName': 'Stockdill', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wells', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ejem', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Konda', 'Initials': 'K', 'LastName': 'Keebler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Sockwell', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Sheri', 'Initials': 'S', 'LastName': 'Tims', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Burgio', 'Affiliation': 'Division of Gerontology, Department of Medicine, Geriatrics, Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Engler', 'Affiliation': 'School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Raegan', 'Initials': 'R', 'LastName': 'Durant', 'Affiliation': 'Division of Preventative Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Salpy V', 'Initials': 'SV', 'LastName': 'Pamboukian', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Tallaj', 'Affiliation': 'Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Division of Gerontology, Department of Medicine, Geriatrics, Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kvale', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Tucker', 'Affiliation': 'Department of Medicine, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': 'Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",Journal of palliative care,['10.1177/0825859720975978']
3036,33258417,Increased Velocity at VO 2 max and Load Carriage Performance in Army ROTC Cadets: Prescription Using the Critical Velocity Concept.,"The purpose of this study was to evaluate the effects of using the critical velocity (CV) concept to prescribe two separate high-intensity interval training (HIT) exercise programs aimed at enhancing CV and load carriage performance. Twenty young adult participants (male =15, female =5) underwent a 4-week training period where they exercised 2 d·wk -1 . Participants were randomly assigned into two groups: 1) HIT or 2) Load Carriage-HIT (LCHIT). Pre and post-training assessments included running 3-minute All-Out Test to determine CV and distance prime ( D' ) and two load carriage tasks (400 m and 3200 m). There were significant increases in CV ( p = .005) and velocity at V̇O 2max ( v V̇O 2max ) ( p = .037) among the sample but not between training groups. Improvements were observed in 3200 m load carriage performance time ( p < .001) with a 9.8% and 5.4% decrease in the LCHIT and HIT groups, respectively. Practitioner summary: Critical velocity has shown efficacy as a marker for performance in tactical populations. With the addition of load carriage, there is a reduction in the individual's CV. The CV-concept-prescribed exercises (HIT and LCHIT) 2 d·wk -1 for four weeks showed improvements in CV, v V̇O 2max and load carriage performance. The use of the CV concept provides a method to prescribe HIT to increase running and load carriage performances in tactical populations.",2020,"Improvements were observed in 3200 m load carriage performance time ( p < .001) with a 9.8% and 5.4% decrease in the LCHIT and HIT groups, respectively. ","['Twenty young adult participants (male =15, female =5', 'Army ROTC Cadets']","['critical velocity (CV) concept to prescribe two separate high-intensity interval training (HIT) exercise programs', 'HIT or 2) Load Carriage-HIT (LCHIT']","['load carriage performance time', 'Increased Velocity at VO 2 max and Load Carriage Performance', 'CV', 'velocity at V̇O 2max', ""running 3-minute All-Out Test to determine CV and distance prime ( D' ) and two load carriage tasks"", 'CV, v V̇O 2max and load carriage performance']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}]",20.0,0.036807,"Improvements were observed in 3200 m load carriage performance time ( p < .001) with a 9.8% and 5.4% decrease in the LCHIT and HIT groups, respectively. ","[{'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Dicks', 'Affiliation': 'Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, Fargo, ND, USA.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Mahoney', 'Affiliation': 'Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, Fargo, ND, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Physical Activity, Sport and Recreation Research Focus Area, North West University, Potchefstroom 2502, South Africa.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Lyman', 'Affiliation': 'Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, Fargo, ND, USA.'}, {'ForeName': 'Bryan K', 'Initials': 'BK', 'LastName': 'Christensen', 'Affiliation': 'Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, Fargo, ND, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Pettitt', 'Affiliation': 'Office of Research & Sponsored Projects, Rocky Mountain University of Health Professions, Provo, UT, USA.'}, {'ForeName': 'Kyle J', 'Initials': 'KJ', 'LastName': 'Hackney', 'Affiliation': 'Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, Fargo, ND, USA.'}]",Ergonomics,['10.1080/00140139.2020.1858186']
3037,33258358,Effectiveness and safety of Chinese herbal medicines for hepatitis B virus-related acute-on-chronic liver failure: study protocol for a multicenter randomized controlled trial.,"OBJECTIVE
To conduct a multicenter randomized controlled trial of the efficacy of standardized Chinese herbal medicines (CHMs) against acute- on-chronic liver failure (ACLF) and provide reproducible and high-level evidence for clinical practice.
METHODS
This is a prospective, multicenter, centrally randomized controlled trial. Patients diagnosed with hepatitis B virus-related ACLF (n = 510) will be allocated to the standard medical therapy or CHM group at a 1∶1 ratio. Two CHMs will be used on the basis of the traditional Chinese medicine syndrome: Liangxue Jiedu granules for excess syndromes and Yiqi Jiedu granules for deficiency syndromes. The primary outcome is transplant-free survival at week 12. The secondary outcomes are (a) transplant-free survival at week 24, (b) liver function as assessed using the model for end-stage liver disease score at week 12, (c) liver function as assessed using the Child-Pugh score at week 12, and (d) the incidence of complications at week 12.
DISCUSSION
The effectiveness and safety of CHM formulations will be assessed following treatment for ACLF.",2020,The primary outcome is transplant-free survival at week 12.,"['Patients diagnosed with hepatitis B virus-related ACLF (n = 510', 'hepatitis B virus-related acute-on-chronic liver failure']","['standard medical therapy or CHM', 'standardized Chinese herbal medicines (CHMs', 'Chinese herbal medicines']","['Effectiveness and safety', 'transplant-free survival', 'incidence of complications', 'transplant-free survival at week 24, (b) liver function as assessed using the model for end-stage liver disease score at week 12, (c) liver function as assessed using the Child-Pugh score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C3850141', 'cui_str': 'Acute on chronic liver failure'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0008525', 'cui_str': 'Choroideremia'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}]",510.0,0.265062,The primary outcome is transplant-free survival at week 12.,"[{'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Lifu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Xiaohe', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': 'Integrated Traditional Chinese Medicine & Western Medicine Department, the Fifth Medical Center, General Hospital of PLA, Beijing 100039, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.06.017']
3038,33258357,Cerebral fractional amplitude of low-frequency fluctuations may predict headache intensity improvement following acupuncture treatment in migraine patients.,"OBJECTIVE
To explore how baseline resting-state cerebral function predicts clinical outcomes of acupuncture treatment for migraine.
METHODS
One hundred migraine patients and 46 healthy subjects were recruited. Patients were randomized into the acupuncture, sham acupuncture, and waiting list groups. Resting-state functional magnetic resonance imaging data were collected at baseline and after 1 month of longitudinal acupuncture treatments. Fractional amplitude of low-frequency fluctuations (fALFF) calculations were applied to explore the associations between baseline fALFF and changes in clinical variables in the acupuncture treatment group and the waiting list group.
RESULTS
Compared with healthy subjects, migraine patients had lower fALFF in the left rostral ventromedial medulla, right thalamus, left amygdala, and right angular gyrus. Regression analyses revealed that baseline fALFF values in the left middle frontal gyrus, left superior temporal gyrus, and middle temporal gyrus were positively associated with headache intensity changes in the acupuncture treatment group, while baseline fALFF values in the bilateral lingual gyrus and cuneus were negatively associated with headache intensity changes in this group.
CONCLUSION
The baseline fALFF values of brain regions associated with cognitive pain modulation, but not migraine severity, may predict future headache intensity improvement levels in migraine patients receiving acupuncture treatment.",2020,"Compared with healthy subjects, migraine patients had lower fALFF in the left rostral ventromedial medulla, right thalamus, left amygdala, and right angular gyrus.","['migraine patients receiving', 'One hundred migraine patients and 46 healthy subjects were recruited', 'migraine patients']","['acupuncture, sham acupuncture, and waiting list groups', 'acupuncture']","['headache intensity improvement', 'baseline fALFF values', 'Fractional amplitude of low-frequency fluctuations (fALFF) calculations', 'headache intensity changes']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}, {'cui': 'C0428760', 'cui_str': 'Intensity change'}]",100.0,0.0637418,"Compared with healthy subjects, migraine patients had lower fALFF in the left rostral ventromedial medulla, right thalamus, left amygdala, and right angular gyrus.","[{'ForeName': 'Zhengjie', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Shirui', 'Initials': 'S', 'LastName': 'Cheng', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Ruirui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Mailan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Acupuncture & Tuina School, Hunan University of Chinese Medicine, Changsha 410000, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Taipin', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Qiyong', 'Initials': 'Q', 'LastName': 'Gong', 'Affiliation': 'Huaxi Magnetic Resonance Research Center, West China Hospital of Sichuan University, Chengdu 610000, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}, {'ForeName': 'Fanrong', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Acupuncture & Tuina School/The Third Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu 610000, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.06.016']
3039,33258356,Effect of spinal manipulation on degenerative scoliosis.,"OBJECTIVE
To investigate the effect of spinal manipulation (SM) on degenerative scoliosis by evaluating patients' visual analog scale (VAS) scores, Cobb angles, sagittal vertical axis (SVA), and apical vertebral rotation (AVR) and to explore factors that influence treatment effect.
METHODS
A total of 55 patients with degenerative scoliosis received 4 weeks of SM. After treatment, patients were divided into two groups: the remission group (VAS score < 40 mm) and the non-remission group (VAS score ≥ 40 mm). Pre- versus post-treatment VAS scores, Cobb angles, SVA, and AVR were compared in each group and in the total population. Baseline data (sex, age, symptom characteristics, duration of symptoms, VAS score, Cobb angle, SVA, and AVR) were compared between groups. Factors influencing the post-treatment VAS score were explored with multiple linear regression analysis.
RESULTS
No changes were found in the Cobb angle (P = 0.722) or AVR (P = 0.424) after intervention in the overall population. However, the SVA (P < 0.001) and VAS score (P = 0.000) changed significantly after treatment. Similar changes were observed in the remission group (n = 29). Multiple linear regression revealed that the only factors influencing treatment effect were symptom characteristics, SVA, and VAS score.
CONCLUSION
SM relieved pain and improved sagittal imbalance in patients with degenerative scoliosis. It did not lessen the severity of coronal curvature or vertebral rotation. Factors influencing the effect of SM included symptom characteristics, VAS score, and SVA. A larger randomized trial is needed to further confirm our results.",2020,"However, the SVA (P < 0.001) and VAS score (P = 0.000) changed significantly after treatment.","['patients with degenerative scoliosis', 'degenerative scoliosis', '55 patients with degenerative scoliosis']","['SM', 'spinal manipulation', 'spinal manipulation (SM']","['Baseline data (sex, age, symptom characteristics, duration of symptoms, VAS score, Cobb angle, SVA, and AVR', 'severity of coronal curvature or vertebral rotation', 'Cobb angle', ""degenerative scoliosis by evaluating patients' visual analog scale (VAS) scores, Cobb angles, sagittal vertical axis (SVA), and apical vertebral rotation (AVR"", 'symptom characteristics, SVA, and VAS score', 'symptom characteristics, VAS score, and SVA', 'VAS scores, Cobb angles, SVA, and AVR', 'SM relieved pain and improved sagittal imbalance', 'VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4280905', 'cui_str': 'Degenerative scoliosis'}]","[{'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C4280905', 'cui_str': 'Degenerative scoliosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",55.0,0.0357449,"However, the SVA (P < 0.001) and VAS score (P = 0.000) changed significantly after treatment.","[{'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Spine Department 2, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China.'}, {'ForeName': 'Jinghua', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Spine Department 2, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China.'}, {'ForeName': 'Liguo', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Spine Department 2, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China.'}, {'ForeName': 'Baojian', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Spine Department 2, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': 'State Key Laboratory of Pharmaceutical New-Tech for Chinese Medicine, Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, Jiangsu Province, China.'}, {'ForeName': 'Zhenzhong', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Pharmaceutical New-Tech for Chinese Medicine, Jiangsu Kanion Pharmaceutical Co., Ltd., Lianyungang 222001, Jiangsu Province, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Spine Department 2, Wangjing Hospital of China Academy of Chinese Medical Sciences, Beijing 100102, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.06.015']
3040,33258355,Therapeutic efficacy of traditional Chinese exercises and massage treatment on lumbar instability: a randomized controlled trial.,"OBJECTIVE
To determine the effect of traditional Chinese exercises combined with traditional Chinese massage on lumbar instability.
METHODS
Seventy patients with lumbar instability were randomly divided into experimental group and control group. The experimental group was treated with traditional Chinese exercises combined with traditional Chinese massage, while the control group was only treated with traditional Chinese exercises. The Japanese Orthopaedic Association (JOA) scores, Oswestry Disability Index (ODI) and dynamic imaging indexes were used to assess treatment outcomes.
RESULTS
After 8 weeks of treatment, the JOA scores of both groups were significantly higher than those before treatment (P < 0.05), while ODI was significantly lower (P < 0.05). In addition, compared with the control group, the JOA score of the experimental group was significantly increased (P < 0.05), and the ODI was significantly decreased (P < 0.05). Besides, the dynamic imaging indexes of patients with lumbar instability significantly changed after treatment. The lumbar vertebral laxity was significantly decreased (P < 0.05) than those before treatment.
CONCLUSION
The traditional Chinese exercises and massage may improve the symptoms of lumbar instability, and traditional Chinese exercises combined with massage treatment may be better than exercises alone.",2020,"The lumbar vertebral laxity was significantly decreased (P < 0.05) than those before treatment.
","['Seventy patients with lumbar instability', 'lumbar instability']","['traditional Chinese exercises and massage treatment', 'traditional Chinese exercises and massage', 'traditional Chinese exercises combined with traditional Chinese massage, while the control group was only treated with traditional Chinese exercises', 'traditional Chinese exercises combined with traditional Chinese massage']","['ODI', 'lumbar vertebral laxity', 'JOA score', 'lumbar instability', 'Therapeutic efficacy', 'JOA scores', 'Japanese Orthopaedic Association (JOA) scores, Oswestry Disability Index (ODI) and dynamic imaging indexes']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",70.0,0.0196094,"The lumbar vertebral laxity was significantly decreased (P < 0.05) than those before treatment.
","[{'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Yide', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Wuxi Huishan Traditional Chinese Medicine hospital, Jiangsu 214071, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'College of Information Science and Engineering Huaqiao University, Fujian 361021, China.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Zhiyi', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Yafeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu 214071, China.'}, {'ForeName': 'Yide', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'Wuxi Huishan Traditional Chinese Medicine hospital, Jiangsu 214071, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'College of Information Science and Engineering Huaqiao University, Fujian 361021, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.06.014']
3041,33258354,Effectiveness of flesh-moistening paste in psoriasis vulgaris patients with symptom pattern of blood stasis: a randomized and parallel-controlled trial.,"OBJECTIVE
To evaluate the efficacy and safety of flesh-moistening paste for treating psoriasis vulgaris in patients with blood stasis pattern in terms of Traditional Chinese Medicine (TCM).
METHODS
Eudipleural rashes on both the left and right side of the same patients with psoriasis vulgaris, diagnosed via TCM as blood stasis pattern, were selected as the targeted skin lesions. A randomized, double-blind, parallel-controlled, multicenter controlled trial was conducted. The targeted skin lesions were categorized into either the treatment or control group. The treatment group used the flesh-moistening paste; the control group used a placebo. Both the paste and the placebo were topically applied twice daily for eight weeks. The patients were examined biweekly to evaluate the effects. The two groups were compared in terms of the psoriasis area and severity index (PASI) of the targeted skin lesions, which is scored according to erythema, desquamation, infiltration, area, pruritus, and improvement of skin barrier function. Adverse events were recorded during the study period. SPSS 21.0 was used to analyze the data.
RESULTS
Fifty-six patients were enrolled between February 2016 and October 2017. Two were complicated by cardio-cerebrovascular disease and were excluded; thus, 54 outpatients were finally enrolled in the study. Four dropped out during the study period: three failed to complete their follow-up visits for unknown reasons, and one exited due to an adverse event. The final trial comprised 50 of the 56 originally selected patients, with a 92.6% completion rate. After 8 weeks of treatment, the targeted skin lesion scores differed significantly (P < 0.05). The PASI scores of the targeted skin lesions differed significantly beginning at week 6 (P < 0.05). The treatment group presented better results than those of the control group. Only one patient had an adverse reaction associated with the treatment. Improvements in skin barrier function differed significantly (P < 0.05).
CONCLUSION
The flesh-moistening paste demonstrated a reliable curative effect and safety for treating psoriasis vulgaris in patients with blood stasis patterns. The topical paste improved the barrier function of the skin lesions.",2020,"Improvements in skin barrier function differed significantly (P < 0.05).
","['Fifty-six patients were enrolled between February 2016 and October 2017', 'psoriasis vulgaris patients with symptom pattern of blood stasis', 'patients with blood stasis pattern in terms of Traditional Chinese Medicine (TCM', 'patients with blood stasis patterns', 'Eudipleural rashes on both the left and right side of the same patients with psoriasis vulgaris, diagnosed via TCM as blood stasis pattern, were selected as the targeted skin lesions', 'Two were complicated by cardio-cerebrovascular disease and were excluded; thus, 54 outpatients were finally enrolled in the study']","['flesh-moistening paste', 'topical paste', 'placebo']","['barrier function of the skin lesions', 'psoriasis area and severity index (PASI) of the targeted skin lesions, which is scored according to erythema, desquamation, infiltration, area, pruritus, and improvement of skin barrier function', 'PASI scores of the targeted skin lesions', 'skin barrier function', 'Adverse events', 'efficacy and safety', 'adverse reaction', 'targeted skin lesion scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0436318', 'cui_str': 'Symptom pattern'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0333138', 'cui_str': 'Stasis'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0037289', 'cui_str': 'Skin function'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C3670862', 'cui_str': 'Target skin lesion'}]",54.0,0.02414,"Improvements in skin barrier function differed significantly (P < 0.05).
","[{'ForeName': 'Xinwei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lang', 'Affiliation': 'Dermatology Department, China Academy of Chinese Medical Sciences Xiyuan Hospital, Beijing 100091, China.'}, {'ForeName': 'Guanru', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Shunyi Branch, Beijing 101300, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Beijing Institute of Traditional Chinese Medicine ,Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Cang', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'BingXu', 'Initials': 'B', 'LastName': 'Deng', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Weihai', 'Initials': 'W', 'LastName': 'Lou', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Jingna', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Haibing', 'Initials': 'H', 'LastName': 'Lan', 'Affiliation': 'Dermatology Department, Gulou Hospital of Traditional Chinese Medicine of Beijing, Beijing 100009, China.'}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Weishu', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}, {'ForeName': 'Liyun', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Dermatology Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing 100010, China.'}]",Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan,['10.19852/j.cnki.jtcm.2020.06.013']
3042,33258284,Objective adherence to dental device versus positive airway pressure treatment in adults with obstructive sleep apnea.,"Although mandibular advancement device (MAD) treatment of adults with obstructive sleep apnea (OSA) is generally less efficacious than positive airway pressure (PAP), the two treatments are associated, with similar clinical outcomes. As a sub-analysis of a randomized trial comparing the effect of MAD versus PAP on blood pressure, this study compared objectively measured adherence to MAD versus PAP treatment in adults with OSA. Adults with OSA (age 54.1 ± 11.2 [standard deviation] years, 71.1% male, apnea-hypopnea index 31.6 ± 22.7 events/h) were randomized to MAD (n = 89) or PAP (n = 91) treatment for 3-6 months. Objective adherence was assessed with a thermal sensor embedded in the MAD and a pressure sensor in the PAP unit. In a per protocol analysis, no difference was observed in average daily hours of use over all days in participants on MAD (n = 35, 4.4 ± 2.9 h) versus PAP (n = 51, 4.7 ± 1.6 h, p = .597) treatment when days with missing adherence data were included as no use. MAD was used on a lower percentage of days (62.5 ± 36.4% versus 79.9 ± 19.8%, p = .047), but with greater average daily hours of use on days used (6.4 ± 1.9 h versus 5.7 ± 1.2 h, p = .013). Average daily hours of use in the first week were associated with long-term adherence to MAD (p < .0001) and PAP (p = .0009) treatment. Similar results were obtained when excluding days with missing adherence data. In conclusion, no significant difference was observed in objectively measured average daily hours of MAD and PAP adherence in adults with OSA, despite differences in the patterns of use. MAD adherence in the first week predicted long-term use.",2020,Average daily hours of use in the first week were associated with long-term adherence to MAD (p < .0001) and PAP (p = .0009) treatment.,"['adults with obstructive sleep apnea (OSA', 'adults with OSA', 'Adults with OSA (age 54.1\xa0±\xa011.2 [standard deviation] years, 71.1% male, apnea-hypopnea index 31.6\xa0±', 'adults with obstructive sleep apnea']","['MAD versus PAP', 'dental device versus positive airway pressure treatment', 'mandibular advancement device (MAD', 'MAD', 'PAP']","['MAD and PAP', 'MAD adherence', 'blood pressure', 'Objective adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]","[{'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2091299', 'cui_str': 'Mandibular Advancement Devices'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",91.0,0.0429702,Average daily hours of use in the first week were associated with long-term adherence to MAD (p < .0001) and PAP (p = .0009) treatment.,"[{'ForeName': 'Liyue', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ""Sleep Center, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Kara S', 'Initials': 'KS', 'LastName': 'Griffin', 'Affiliation': ""Sleep Medicine and Research Center, St. Luke's Hospital, Chesterfield, MO, USA.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Staley', 'Affiliation': 'Division of Sleep Medicine, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Villanova University, Villanova, PA, USA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Nichols', 'Affiliation': 'Department of Psychiatry, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Benca', 'Affiliation': 'Department of Psychiatry and Human Behavior, University of California, Irvine, CA, USA.'}, {'ForeName': 'Allan I', 'Initials': 'AI', 'LastName': 'Pack', 'Affiliation': 'Division of Sleep Medicine, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Redline', 'Affiliation': ""Division of Sleep and Circadian Disorders, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Walsh', 'Affiliation': ""Sleep Medicine and Research Center, St. Luke's Hospital, Chesterfield, MO, USA.""}, {'ForeName': 'Clete A', 'Initials': 'CA', 'LastName': 'Kushida', 'Affiliation': 'Villanova University, Villanova, PA, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Kuna', 'Affiliation': 'Division of Sleep Medicine, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.'}]",Journal of sleep research,['10.1111/jsr.13240']
3043,33258274,Effects of bright light and an afternoon nap on task performance depend on the cognitive domain.,"Previous research revealed inconsistent effects of bright light or a short nap at noon on alertness and performance across different tasks. The current study aimed to explore whether the effects of bright light and a short nap at noon on task performance depended on the cognitive domain. Bright light (1,200 lx, 4,000 K at eye level), nap (near darkness) and control (200 lx, 4,000 K at eye level) conditions were performed from 1:00 to 1:40 PM on three non-consecutive days with a counterbalanced order across participants. After being assigned to one of three conditions, participants underwent two repeated test sessions, each including a psychomotor vigilance task, a go/no-go task, and a paced visual serial addition task, with an interval of more than 1 h, to assess the persistent effects of napping and bright light. Subjective sleepiness, vitality, self-control and mood were also measured. Results showed that accuracy on the go/no-go task and the paced visual serial addition task improved significantly throughout the entire experiment session after napping, whereas reaction speed on the paced visual serial addition task improved time-dependently in the bright light intervention, with a higher reaction speed in only the first test session. Nearly all subjective states benefited from napping but not from bright light. These findings suggested that the effects of bright light and an afternoon nap on task performance would depend on the cognitive domain. An afternoon nap may elicit more effective and persistent benefits on task performance and subjective states.",2020,"Results showed that accuracy on the go/no-go task and the paced visual serial addition task improved significantly throughout the entire experiment session after napping, whereas reaction speed on the paced visual serial addition task improved time-dependently in the bright light intervention, with a higher reaction speed in only the first test session.",[],"['psychomotor vigilance task, a go/no-go task, and a paced visual serial addition task', 'bright light and a short nap at noon', 'bright light and an afternoon nap', 'Bright light (1,200\xa0lx, 4,000\xa0K at eye level), nap (near darkness) and control']","['reaction speed on the paced visual serial addition task improved time', 'accuracy on the go/no-go task and the paced visual serial addition task', 'Subjective sleepiness, vitality, self-control and mood', 'task performance']",[],"[{'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0585020', 'cui_str': 'Noon'}, {'cui': 'C0439550', 'cui_str': 'Afternoon'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0010986', 'cui_str': 'Darkness'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0214682,"Results showed that accuracy on the go/no-go task and the paced visual serial addition task improved significantly throughout the entire experiment session after napping, whereas reaction speed on the paced visual serial addition task improved time-dependently in the bright light intervention, with a higher reaction speed in only the first test session.","[{'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Lab of Light and Physio-psychological Health, School of Psychology, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Taotao', 'Initials': 'T', 'LastName': 'Ru', 'Affiliation': 'National Center for International Research on Green Optoelectronics, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Lab of Light and Physio-psychological Health, School of Psychology, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Lab of Light and Physio-psychological Health, School of Psychology, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'National Center for International Research on Green Optoelectronics, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Guofu', 'Initials': 'G', 'LastName': 'Zhou', 'Affiliation': 'National Center for International Research on Green Optoelectronics, South China Normal University, Guangzhou, China.'}]",Journal of sleep research,['10.1111/jsr.13242']
3044,33258271,Endoscopic lithotripsy with a SuperPulsed thulium-fiber laser for ureteral stones: A single-center experience.,"OBJECTIVES
To estimate the efficacy and safety of SuperPulsed thulium-fiber laser ureteral lithotripsy and to identify optimal laser settings.
METHODS
Patients with solitary stones were prospectively included. Lithotripsy was performed with a SuperPulsed thulium-fiber laser (NTO IRE-Polus, Fryazino, Russia) using a rigid ureteroscope 7.5 Ch (Richard Wolf, Knittlingen, Germany). We analyzed the efficacy of lithotripsy by measuring total energy required for stone disintegration, ""laser-on"" time, ablation speed, ablation efficacy, and energy consumption. Stone retropulsion and visibility were assessed using a three-point Likert scale. Complications were assessed using the Clavien-Dindo classification system.
RESULTS
A total of 149 patients were included. The mean stone density was 985 ± 360 Hounsfield units, the median (interquartile range) stone volume was 179 (94-357) mm 3 . The median (interquartile range) total energy was 1 (0.4-2) kJ, and laser-on time 1.2 (0.5-2.7) min. The median (interquartile range) stone ablation speed was 140 (80-279) mm 3 /min, energy for ablation of 1 mm 3 was 5.6 (3-9.9) J/mm 3 and energy consumption was 0.9 (0.6-1) J/min. A correlation was found between retropulsion and the energy used (r = 0.5, P < 0.001). Multivariable analysis showed energy to be a predictor of increased retropulsion (odds ratio 65.7, 95% confidence interval 1.6-2774.1; P = 0.028). No predictors for worse visibility were identified.
CONCLUSION
The SuperPulsed thulium-fiber laser provides effective and safe lithotripsy during ureteroscopy regardless of stone density. Fiber diameter and laser frequency do not influence visibility or safety. Optimal laser settings are 0.5 J × 30 Hz for fragmentation and 0.15 J × 100 Hz for dusting.",2020,The SuperPulsed thulium-fiber laser provides effective and safe lithotripsy during ureteroscopy regardless of stone density.,"['Patients with solitary stones', 'A total of 149 patients were included']","['Endoscopic lithotripsy with a SuperPulsed thulium-fiber laser', 'Lithotripsy was performed with a SuperPulsed thulium-fiber laser (NTO IRE-Polus, Fryazino, Russia) using a rigid ureteroscope 7.5 Ch (Richard Wolf, Knittlingen, Germany', 'SuperPulsed thulium-fiber laser ureteral lithotripsy', 'lithotripsy']","['Stone retropulsion and visibility', 'median (interquartile range) stone ablation speed', 'median (interquartile range) total energy', 'mean stone density', 'efficacy and safety', 'stone disintegration, ""laser-on"" time, ablation speed, ablation efficacy, and energy consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1512886', 'cui_str': 'Internal Ribosome Entry Site'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0392307', 'cui_str': 'Rigid ureteroscope'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0558630', 'cui_str': 'Ureteric lithotripsy'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0277845', 'cui_str': 'Retropulsion'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1265875', 'cui_str': 'Disintegration'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",149.0,0.0487271,The SuperPulsed thulium-fiber laser provides effective and safe lithotripsy during ureteroscopy regardless of stone density.,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Enikeev', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Vagarshak', 'Initials': 'V', 'LastName': 'Grigoryan', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Fokin', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Morozov', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Taratkin', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Klimov', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Vasiliy', 'Initials': 'V', 'LastName': 'Kozlov', 'Affiliation': 'Department of Public Health and Healthcare, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Gabdullina', 'Affiliation': 'Institute of Linguistics and Intercultural Communication, Sechenov University, Moscow, Russia.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Glybochko', 'Affiliation': 'Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia.'}]",International journal of urology : official journal of the Japanese Urological Association,['10.1111/iju.14443']
3045,33258213,Nasal High Flow Oxygen Versus Conventional Oxygen Therapy for Acute Severe Asthma Patients: A Pilot Randomized Controlled Trial.,"BACKGROUND
Nasal high flow (NHF) has demonstrated efficacy in relieving dyspnea in various patients with hypoxemic and hypercapnic respiratory failure. It may also reduce dyspnea in patients with acute severe asthma in the Emergency Department (ED). The aim of the study was to compare the efficacy of NHF with conventional oxygen therapy (COT) in improving dyspnea in acute severe asthma patients with hypoxemia in the ED.
METHODS
This pilot non-blinded randomized controlled trial was conducted involving 37 patients aged ≥ 18 years with acute severe asthma and hypoxemia in the ED of Siriraj Hospital, Bangkok, Thailand (TCTR20180926003). The participants were randomly allocated to receive either COT (n = 18) or NHF (n = 19) for 120 minutes. The primary outcome was comparing the intervention effects on the patients' degree of dyspnea measured using the modified Borg scale (MBS). The secondary outcomes were comparing the interventions based on the numerical rating scale (NRS) of dyspnea, the dyspnea scale assessing accessory muscle use, vital signs and blood gas results.
RESULTS
The intention-to-treat analysis included 37 patients (COT group n = 18 and NHF group n = 19). The baseline mean MBS was 7.8 in both groups. At 120 minutes, the mean MBS in patients receiving COT and NHF was 3.3 (SD 2.5) and 1.4 (SD 2.5), respectively [mean difference 1.9 (95% CI 0.2, 3.8); p = 0.043]. The trends of NRS and dyspnea score results were similar to MBS. Respiratory rates were lower with NHF [mean difference 4.7(95% CI 1.5, 7.8); p = 0.001). No between- or within-group differences in blood gas results were found.
CONCLUSION
NHF reduced the severity of dyspnea and respiratory rate in hypoxemic patients with acute severe asthma in the ED.",2020,"Respiratory rates were lower with NHF [mean difference 4.7(95% CI 1.5, 7.8); p = 0.001).","['37 patients aged ≥ 18 years with acute severe asthma and hypoxemia in the ED of Siriraj Hospital, Bangkok, Thailand (TCTR20180926003', 'hypoxemic patients with acute severe asthma in the ED', 'various patients with hypoxemic and hypercapnic respiratory failure', 'acute severe asthma patients with hypoxemia in the ED', 'patients with acute severe asthma in the Emergency Department (ED', 'Acute Severe Asthma Patients', '37 patients (COT group n = 18 and NHF group n = 19']","['NHF', 'COT', 'Nasal high flow (NHF', 'Nasal High Flow Oxygen Versus Conventional Oxygen Therapy', 'NHF with conventional oxygen therapy (COT']","['blood gas results', 'dyspnea', 'numerical rating scale (NRS) of dyspnea, the dyspnea scale assessing accessory muscle use, vital signs and blood gas results', 'mean MBS', 'severity of dyspnea and respiratory rate', 'Respiratory rates', 'baseline mean MBS', ""patients' degree of dyspnea measured using the modified Borg scale (MBS"", 'NRS and dyspnea score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038218', 'cui_str': 'Acute severe exacerbation of asthma'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0158784', 'cui_str': 'Accessory skeletal muscle'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449399', 'cui_str': 'Borg scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.194181,"Respiratory rates were lower with NHF [mean difference 4.7(95% CI 1.5, 7.8); p = 0.001).","[{'ForeName': 'Onlak', 'Initials': 'O', 'LastName': 'Ruangsomboon', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital Mahidol University, 2 Wanglang Road, Bangkoknoi Bangkok, Thailand, 10700.'}, {'ForeName': 'Chok', 'Initials': 'C', 'LastName': 'Limsuwat', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital Mahidol University, 2 Wanglang Road, Bangkoknoi Bangkok, Thailand, 10700.'}, {'ForeName': 'Nattakarn', 'Initials': 'N', 'LastName': 'Praphruetkit', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital Mahidol University, 2 Wanglang Road, Bangkoknoi Bangkok, Thailand, 10700.'}, {'ForeName': 'Apichaya', 'Initials': 'A', 'LastName': 'Monsomboon', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital Mahidol University, 2 Wanglang Road, Bangkoknoi Bangkok, Thailand, 10700.'}, {'ForeName': 'Tipa', 'Initials': 'T', 'LastName': 'Chakorn', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Siriraj Hospital Mahidol University, 2 Wanglang Road, Bangkoknoi Bangkok, Thailand, 10700.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14187']
3046,33258168,A clinical investigation into the efficacy of miswak chewing sticks as an oral hygiene aid: A crossover randomized trial.,"OBJECTIVES
This study evaluates the effect of using miswak chewing sticks on dental plaque, selected oral microbiota and gingival inflammation among patients with gingivitis.
METHODS
The study was a single center, single-examiner blind, randomized, cross-over study. Twenty healthy participants were randomly assigned into two equal groups (n=10). Group 1 were instructed to use both toothbrush and miswak (TB+M) for the first 2 weeks from baseline (T1) and only toothbrush for the next 2 weeks (T2); and Group 2, only TB during T1 and TB+M during T2. Gingival index (GI), plaque index (PI) and bleeding on probing (BOP) were evaluated at baseline (T0), T1 and T2 visits. Supra-gingival plaque samples were taken at T0, T1 and T2. Quantification of Streptococcus mutans and Aggregatibacter actinomycetemcomitans from the supra-gingival plaque samples were performed by real-time polymerase chain reaction (qPCR).
RESULTS
The scores of GI, PI and BOP had significantly improved for both groups between T0 and T1. A significantly greater reduction in the percentage of sites with BOP was observed for TB+M group compared with TB group (TB+M group: from 32.2 to 14.93; TB group: from 34.00 to 26.0; p=0.014). At T2, TB+M group had significant improvements (p<0.05) in the PI, GI and BOP scores compared with TB group. There was no significant difference in the microbial counts of S. mutans and A. actinomycetemcomitans between the two groups at the end of the study period.
CONCLUSIONS
Oral hygiene and gingival health may be improved by complementing miswak chewing sticks with toothbrushing.",2020,A significantly greater reduction in the percentage of sites with BOP was observed for TB+M group compared with TB group (TB+M group: from 32.2 to 14.93; TB group: from 34.00 to 26.0; p=0.014).,"['patients with gingivitis', 'Twenty healthy participants']","['toothbrush and miswak (TB+M', 'miswak chewing sticks']","['Gingival index (GI), plaque index (PI) and bleeding on probing (BOP', 'dental plaque, selected oral microbiota and gingival inflammation', 'microbial counts of S. mutans and A. actinomycetemcomitans', 'PI, GI and BOP scores', 'scores of GI, PI and BOP', 'percentage of sites with BOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C1706582', 'cui_str': 'Stick'}]","[{'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2945843', 'cui_str': 'Site of'}]",20.0,0.048352,A significantly greater reduction in the percentage of sites with BOP was observed for TB+M group compared with TB group (TB+M group: from 32.2 to 14.93; TB group: from 34.00 to 26.0; p=0.014).,"[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Rifaey', 'Affiliation': 'Final year student, Faculty of Dentistry, Kuwait University, Kuwait.'}, {'ForeName': 'Manar', 'Initials': 'M', 'LastName': 'AlAdwani', 'Affiliation': 'Final year student, Faculty of Dentistry, Kuwait University, Kuwait.'}, {'ForeName': 'Maribasappa', 'Initials': 'M', 'LastName': 'Karched', 'Affiliation': 'Department of Bioclinical Sciences, Faculty of Dentistry, Kuwait University, Kuwait.'}, {'ForeName': 'Jagan Kumar', 'Initials': 'JK', 'LastName': 'Baskaradoss', 'Affiliation': 'Department of Developmental and Preventive Sciences, Faculty of Dentistry, Kuwait University, Kuwait.'}]",International journal of dental hygiene,['10.1111/idh.12484']
3047,33258136,5-year randomized multicenter clinical trial on single dental implants placed in the midline of the edentulous mandible.,"OBJECTIVES
This multicenter randomized controlled clinical trial was conducted to investigate whether the loading protocol of single dental implants placed in the midline of edentulous mandibles will influence the implant survival or prosthetic maintenance.
MATERIALS AND METHODS
In total, 158 patients were randomly assigned either to the immediate loading group (n=81) or the delayed loading group (n=77). All implants were loaded with an overdenture retained by a ball attachment.
RESULTS
After 5 years, 102 patients attended the follow-up investigation. Immediately loaded single implants in the midline of the edentulous mandible revealed a statistically significant lower survival rate than implants loaded conventionally over an observation period of 5 years. In the immediate loading group, 9 implants failed within the first three months of implant loading. No further implant loss was recorded for this group. Two implants failed in the delayed loading group, whereas one implant had to be removed during second stage surgery and the second five years after implant loading. Non-inferiority of the survival rate of the midline implant of the immediate loading group, compared to the delayed loading group, could not be shown (p=0.79, CI immediate loading: 74.9%; 100.0%, CI delayed loading: 73.0%; 100.0%). The observed difference in implant survival between the two treatment groups over time was statistically significant.
CONCLUSIONS
The results of the present study indicate, that immediate loading of a single mandibular implant in the edentulous mandible should be considered only in exceptional cases.",2020,Immediately loaded single implants in the midline of the edentulous mandible revealed a statistically significant lower survival rate than implants loaded conventionally over an observation period of 5 years.,"['102 patients attended the follow-up investigation', '158 patients']",['immediate loading group (n=81) or the delayed loading group'],"['implant survival', 'survival rate', 'implant loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",158.0,0.0870633,Immediately loaded single implants in the midline of the edentulous mandible revealed a statistically significant lower survival rate than implants loaded conventionally over an observation period of 5 years.,"[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kern', 'Affiliation': 'Department of Prosthodontics, Propaedeutics and Dental Materials, Christian-Albrechts University at Kiel, Kiel, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Behrendt', 'Affiliation': 'Department of Prosthodontics, Gerodontology and Biomaterials, Greifswald University Hospital, Greifswald, Germany.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Fritzer', 'Affiliation': 'Center for Clinical Studies, Kiel University, University Hospital Schleswig-Holstein, Germany.'}, {'ForeName': 'Ralf Joachim', 'Initials': 'RJ', 'LastName': 'Kohal', 'Affiliation': 'Department of Prosthetic Dentistry, Center for Dental Medicine, Medical Center - University Hospital Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ralph G', 'Initials': 'RG', 'LastName': 'Luthardt Rg', 'Affiliation': 'Center of Dentistry, Department of Prosthetic Dentistry, Ulm University Hospital, Ulm, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Frfr V Maltzahn', 'Affiliation': 'Department of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rädel', 'Affiliation': 'Faculty of Medicine Carl Gustav Carus, TU Desden, Dresden, Germany.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Reissmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Sebastian Schwindling', 'Affiliation': 'Department of Prosthodontics, Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wolfart', 'Affiliation': 'Department of Prosthodontics and Biomaterials, Medical Faculty, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Passia N', 'Affiliation': 'Department of Prosthodontics, Propaedeutics and Dental Materials, Christian-Albrechts University at Kiel, Kiel, Germany.'}]",Clinical oral implants research,['10.1111/clr.13692']
3048,33258114,Impact of lanadelumab on health-related quality of life in patients with hereditary angioedema in the HELP Study.,"BACKGROUND
An objective of the phase 3 HELP Study was to investigate the effect of lanadelumab on health-related quality of life (HRQoL) in patients with hereditary angioedema (HAE).
METHODS
Patients with HAE-1/2 received either lanadelumab 150 mg every 4 weeks (q4wks; n=28), 300 mg q4wks (n=29), 300 mg every 2 weeks (q2wks; n=27), or placebo (n=41) for 26 weeks (days 0-182). The Angioedema Quality of Life Questionnaire (AE-QoL) was administered monthly, consisting of four domain (functioning, fatigue/mood, fears/shame, nutrition) and total scores. The generic EQ-5D-5L questionnaire was administered on days 0, 98, and 182. Comparisons were made between placebo and (1) all lanadelumab-treated patients and (2) individual lanadelumab groups for changes in scores (day 0 to 182) and proportions achieving the minimal clinically important difference (MCID, -6) in AE-QoL total score.
RESULTS
Compared with the placebo group, the lanadelumab total group demonstrated significantly greater improvements in AE-QoL total and domain scores (mean change, -13.0 to -29.3; P<.05 for all); the largest improvement was in functioning. A significantly greater proportion of the lanadelumab total group achieved the MCID (70% vs 37%; P=.001). The lanadelumab 300 mg q2wks group had the highest proportion (81%; P=.001) and was 7.2 times more likely to achieve the MCID than the placebo group. Mean EQ-5D-5L scores at day 0 were high in all groups, indicating low impairment, with no significant changes at day 182.
CONCLUSION
Patients with HAE-1/2 experienced significant and clinically meaningful improvements in HRQoL measured by AE-QoL following lanadelumab treatment in the HELP Study.",2020,The lanadelumab 300 mg q2wks group had the highest proportion (81%; P=.001) and was 7.2 times more likely to achieve the MCID than the placebo group.,"['patients with hereditary angioedema in the HELP Study', 'Patients with HAE-1/2 received either', 'patients with hereditary angioedema (HAE']","['lanadelumab', 'placebo']","['MCID', 'Mean EQ-5D-5L scores', 'health-related quality of life (HRQoL', 'Angioedema Quality of Life Questionnaire (AE-QoL', 'HRQoL', 'health-related quality of life', 'AE-QoL total and domain scores', 'generic EQ-5D-5L questionnaire', 'proportions achieving the minimal clinically important difference (MCID, -6) in AE-QoL total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019243', 'cui_str': 'Hereditary angioedema'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0580272', 'cui_str': '1/2'}]","[{'cui': 'C4505508', 'cui_str': 'lanadelumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002994', 'cui_str': 'Angioedema'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}]",,0.0794152,The lanadelumab 300 mg q2wks group had the highest proportion (81%; P=.001) and was 7.2 times more likely to achieve the MCID than the placebo group.,"[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'Allergy Asthma Research Associates Research Center, Dallas, TX, USA.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Weller', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Magerl', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Aleena', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hilary J', 'Initials': 'HJ', 'LastName': 'Longhurst', 'Affiliation': ""Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, and University College London Hospitals, London, UK.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'Division of Rheumatology, Allergy & Immunology, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Hannah B', 'Initials': 'HB', 'LastName': 'Lewis', 'Affiliation': 'ICON plc, London, UK.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Devercelli', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Jain', 'Affiliation': 'Takeda Pharmaceutical Company Limited, Lexington, MA, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Maurer', 'Affiliation': 'Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Allergy,['10.1111/all.14680']
3049,33258102,Cangrelor in addition to standard therapy reduces cardiac damage and inflammatory markers in patients with ST-segment elevation myocardial infarction.,"Although P2Y12 receptor blockers have become a standard, adjunctive therapy in patients with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI), the optimal regimen has not been established. We performed a prospective, open-label, randomized study to investigate the effect of cangrelor administration on platelet function and inflammation in patients with primary PCI (PPCI). Twenty-two patients were randomized to receive either cangrelor and ticagrelor or ticagrelor alone (standard group) before PPCI. Platelet reactivity was evaluated at baseline (before PCI), 10 min and the end of the procedure. At baseline, there was no significant difference in platelet reactivity between both groups, whereas platelets were significantly inhibited at 10 min after initiating cangrelor vs. standard (adenosine-diphosphate-induced aggregation 102.2 ± 24.88 vs. 333.4 ± 63.3, P < 0.05 and thrombin-receptor-activating-peptide-induced aggregation 285.8 ± 86.1 vs. 624.8 ± 106.0, P < 0.05). Lower platelet aggregation in the cangrelor group persisted but the difference was reduced by the end of the procedure. Circulating inflammatory cells, pro-inflammatory cytokines, total elastase, and surrogates of neutrophil extracellular traps (total elastase-myeloperoxidase complexes) were significantly lower in the cangrelor compared to the standard therapy group at 6 h after randomization. There was a trend towards reduction in cardiac damage in the cangrelor group as reflected by the changes in late gadolinium enhancement between 48 h and 3 months after STEMI. Early administration of cangrelor in STEMI patients was associated with more effective platelet inhibition during PPCI and significantly dampened the deleterious inflammatory response compared to standard therapy (NCT03043274).",2020,"At baseline, there was no significant difference in platelet reactivity between both groups, whereas platelets were significantly inhibited at 10 min after initiating cangrelor vs. standard (adenosine-diphosphate-induced aggregation 102.2 ± 24.88 vs. 333.4 ± 63.3, P < 0.05 and thrombin-receptor-activating-peptide-induced aggregation 285.8 ± 86.1 vs. 624.8 ± 106.0, P < 0.05).","['patients with ST-segment elevation myocardial infarction', 'patients with primary PCI (PPCI', 'patients with ST-segment elevation myocardial infarction (STEMI) undergoing']","['Cangrelor', 'percutaneous coronary intervention (PCI', 'P2Y12 receptor blockers', 'cangrelor and ticagrelor or ticagrelor alone (standard group) before PPCI', 'cangrelor']","['Lower platelet aggregation', 'Platelet reactivity', 'cardiac damage and inflammatory markers', 'cardiac damage', 'effective platelet inhibition', 'platelet reactivity', 'Circulating inflammatory cells, pro-inflammatory cytokines, total elastase, and surrogates of neutrophil extracellular traps (total elastase-myeloperoxidase complexes', 'deleterious inflammatory response', 'late gadolinium enhancement', 'platelet function and inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C1121991', 'cui_str': 'cangrelor'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0392386', 'cui_str': 'Platelet count below reference range'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030306', 'cui_str': 'Pancreatic elastase'}, {'cui': 'C3850088', 'cui_str': 'NETs (Neutrophil Extracellular Traps)'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0920267', 'cui_str': 'Platelet aggregation test'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",22.0,0.0311244,"At baseline, there was no significant difference in platelet reactivity between both groups, whereas platelets were significantly inhibited at 10 min after initiating cangrelor vs. standard (adenosine-diphosphate-induced aggregation 102.2 ± 24.88 vs. 333.4 ± 63.3, P < 0.05 and thrombin-receptor-activating-peptide-induced aggregation 285.8 ± 86.1 vs. 624.8 ± 106.0, P < 0.05).","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abo-Aly', 'Affiliation': 'Gill Heart and Vascular Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Bennet', 'Initials': 'B', 'LastName': 'George', 'Affiliation': 'University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Elica', 'Initials': 'E', 'LastName': 'Shokri', 'Affiliation': 'Gill Heart and Vascular Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Lakshman', 'Initials': 'L', 'LastName': 'Chelvarajan', 'Affiliation': 'Gill Heart and Vascular Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Helw', 'Affiliation': 'Gill Heart and Vascular Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Smyth', 'Affiliation': 'Gill Heart and Vascular Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Abdel-Latif', 'Affiliation': 'Gill Heart and Vascular Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Ziada', 'Affiliation': 'Cardiovascular Interventions, Coronary Artery Disease Center, Department of Cardiovascular Medicine, Heart, Vascular and Thoracic Institute, Cleveland Clinic, Cleveland, USA. ziadak@ccf.org.'}]",Journal of thrombosis and thrombolysis,['10.1007/s11239-020-02345-8']
3050,33258064,The Effect of Exercise During Pregnancy on Maternal and Offspring Vascular Outcomes: a Pilot Study.,"The aim of this pilot study is to obtain estimates for the change in maternal cerebrovascular (primary) and offspring vascular structure (secondary) during healthy pregnancy that includes structured exercise. Eighteen pregnant women self-assigned to a moderate-intensity aerobic exercise intervention or a control group. Maternal cerebral blood flow (CBF) at the middle cerebral artery, cerebro- and peripheral-vascular function was assessed at the end of each trimester. Offspring carotid artery intima-media thickness (IMT) was measured within 12 weeks of birth. For exploratory purposes, we performed statistical analysis to provide estimates of the change for primary and secondary outcome variables. Maternal CBF reduced (- 8 cm s -1 [- 14 to - 2]) with evidence of change to cerebral autoregulation (normalised gain: 0.12 %cm s -1 % mmHg -1 mmHg/% [- 0.18 to 0.40]) during pregnancy. Offspring carotid IMT was smaller in the exercise group (- 0.04 mm [- 0.12-0.03]) compared with controls. Based upon this data, a sample size of 33 and 57 in each group is required for low-frequency normalised gain and offspring IMT, respectively. This would provide 90% power to detect statistically significant (P < 0.05) between group differences in a randomised controlled trial. CBF is reduced in pregnancy, possibly due to reduced vascular resistance and altered maternal cerebral autoregulation. Maternal exercise had negligible effects on cerebrovascular adaptation to pregnancy, but we observed lower offspring carotid artery wall thickness following maternal exercise. Our directional findings and sample size estimations should be explored in a fully powered randomised control trial.Clinical trial registration: The trial was registered on March 14th at https://register.clinicaltrials.gov (NCT03079258). Participant enrolment began on 3rd April 2016.",2020,"Maternal exercise had negligible effects on cerebrovascular adaptation to pregnancy, but we observed lower offspring carotid artery wall thickness following maternal exercise.",['Eighteen pregnant women self-assigned to a'],"['Exercise During Pregnancy', 'CBF', 'moderate-intensity aerobic exercise intervention or a control group', 'Maternal exercise']","['Offspring carotid IMT', 'vascular resistance and altered maternal cerebral autoregulation', 'cerebrovascular adaptation to pregnancy', 'Offspring carotid artery intima-media thickness (IMT', 'Maternal CBF', 'cerebral autoregulation', 'Maternal cerebral blood flow (CBF) at the middle cerebral artery, cerebro- and peripheral-vascular function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0042380', 'cui_str': 'Vascular resistance, function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",18.0,0.376087,"Maternal exercise had negligible effects on cerebrovascular adaptation to pregnancy, but we observed lower offspring carotid artery wall thickness following maternal exercise.","[{'ForeName': 'Áine', 'Initials': 'Á', 'LastName': 'Brislane', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK. a.brislane@yorksj.ac.uk.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jones', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.'}, {'ForeName': 'Sophie M', 'Initials': 'SM', 'LastName': 'Holder', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Low', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.'}, {'ForeName': 'Nicola D', 'Initials': 'ND', 'LastName': 'Hopkins', 'Affiliation': 'Research Institute of Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, L3 3AF, UK.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00302-7']
3051,33258047,[Proton beam therapy versus intensity-modulated radiation therapy for locally advanced esophageal cancer: a randomized phase IIB trial].,,2020,,['locally advanced esophageal cancer'],['Proton beam therapy versus intensity-modulated radiation therapy'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}]","[{'cui': 'C0436226', 'cui_str': 'Proton therapy'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}]",[],,0.0498787,,"[{'ForeName': 'Mechthild', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Anstalt des öffentlichen Rechts des Freistaates Sachsen, Fetscherstraße\xa074, 01307, Dresden, Deutschland. mechthild.krause@uniklinikum-dresden.de.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01714-9']
3052,33258032,Stent treatment or surgical closure for perforated duodenal ulcers: a prospective randomized study.,"BACKGROUND
Perforated peptic ulcer is a life-threatening condition. Traditional treatment is surgery. Esophageal perforations and anastomotic leakages can be treated with endoscopically placed covered stents and drainage. We have treated selected patients with a perforated duodenal ulcer with a partially covered stent. The aim of this study was to compare surgery with stent treatment for perforated duodenal ulcers in a multicenter randomized controlled trial.
METHODS
All patients presenting at the ER with abdominal pain, clinical signs of an upper G-I perforation, and free air on CT were approached for inclusion and randomized between surgical closure and stent treatment. Age, ASA score, operation time, complications, and hospital stay were recorded. Laparoscopy was performed in all patients to establish diagnosis. Surgical closure was performed using open or laparoscopic techniques. For stent treatment, a per-operative gastroscopy was performed and a partially covered stent was placed through the scope. Abdominal lavage was performed in all patients, and a drain was placed. All patients received antibiotics and intravenous PPI. Stents were endoscopically removed after 2-3 weeks. Complications were recorded and classified according to Clavien-Dindo (C-D).
RESULTS
43 patients were included, 28 had a verified perforated duodenal ulcer, 15 were randomized to surgery, and 13 to stent. Median age was 77.5 years (23-91) with no difference between groups. ASA score was unevenly distributed between the groups (p = 0.069). Operation time was significantly shorter in the stent group, 68 min (48-107) versus 92 min (68-154) (p = 0.001). Stents were removed after a median of 21 days (11-37 days) without complications. Six patients in the surgical group had a complication and seven patients in the stent group (C-D 2-5) (n.s.).
CONCLUSIONS
Stent treatment together with laparoscopic lavage and drainage offers a safe alternative to traditional surgical closure in perforated duodenal ulcer. A larger sample size would be necessary to show non-inferiority regarding stent treatment.",2020,"Operation time was significantly shorter in the stent group, 68 min (48-107) versus 92 min (68-154) (p = 0.001).","['patients with a perforated duodenal ulcer with a partially covered stent', '43 patients were included, 28 had a verified perforated duodenal ulcer, 15 were randomized to surgery, and 13 to stent', 'All patients presenting at the ER with abdominal pain, clinical signs of an upper G-I perforation, and free air on CT', 'perforated duodenal ulcers']","['Stent treatment or surgical closure', 'Laparoscopy', 'laparoscopic lavage and drainage', 'antibiotics and intravenous PPI', 'stent treatment']","['Operation time', 'Abdominal lavage', 'Age, ASA score, operation time, complications, and hospital stay', 'ASA score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0740401', 'cui_str': 'Duodenal ulcer with perforation'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0013295', 'cui_str': 'Ulcer of duodenum'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185003', 'cui_str': 'Closure'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",43.0,0.0750745,"Operation time was significantly shorter in the stent group, 68 min (48-107) versus 92 min (68-154) (p = 0.001).","[{'ForeName': 'Jorge Alberto', 'Initials': 'JA', 'LastName': 'Arroyo Vázquez', 'Affiliation': 'Department of Surgery, South Älvsborg Hospital, Brämhultsvägen 53, 501 82, Borås, Sweden. jarroyov@hotmail.com.'}, {'ForeName': 'Kaveh', 'Initials': 'K', 'LastName': 'Khodakaram', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Bergström', 'Affiliation': 'Department of Surgery, Halland Hospital, Varberg, Sweden.'}, {'ForeName': 'Per-Ola', 'Initials': 'PO', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Halland Hospital, Varberg, Sweden.'}]",Surgical endoscopy,['10.1007/s00464-020-08158-3']
3053,32087422,Modified Stark's (Misgav Ladach) caesarean section: 15 - year experience of the own techniques of caesarean section.,"OBJECTIVE
A 15-year-experience of the personal modification of Misgav Ladach (ML) caesarean section in relation to the Dörffler method.
STUDY DESIGN
A retrospective clinical randomized observational study included 822 transperitoneal cesarean sections: 557 were performed via modified ML (without bladder catheterization, small transverse fascial incision with muscular stretching and non-preparation of vesicouterine plica) vs. 265 Dörffler (Pfannenstiel - Kerr) method.
RESULTS
Perioperative and postoperative complications were significantly more frequent in the Dörffler method (p < 0.0005) (perioperative hemorrhage, more frequent adhesions, plastic peritonitis in repeated caesarean sections, as well as two bladder lesions). Postoperative febrility, dehiscence and wound seroma were more frequent in the first study group (p < 0.0005). More frequent paralytic ileus, uroinfections and bladder atony, which we did not observe in our own technique (p < 0.0005). The use of antibiotics and analgesics was prolonged until the fifth postoperative day in the first group compared to the second group where it was reduced to only 10 % on the second day (p < 0.0005). Also, the incidence of anemia and the need for blood transfusions were higher in the first study group, as well as the need for revision behind caesarean section and two hysterectomies due to massive postoperative intraperitoneal and retroperitoneal bleeding (p < 0.0005).
CONCLUSION
Our fifteen-year study highlighted the importance of our own published modified ML caesarean section in minimizing technique of surgery and the reduction of perioperative morbidity and significantly faster recovery of operated patients in the current era of enormous caesarean section increase.",2020,The use of antibiotics and analgesics was prolonged until the fifth postoperative day in the first group compared to the second group where it was reduced to only 10 % on the second day (p < 0.0005).,['822 transperitoneal cesarean sections'],"['modified ML (without bladder catheterization, small transverse fascial incision with muscular stretching and non-preparation of vesicouterine plica) vs. 265 Dörffler (Pfannenstiel - Kerr) method', ""Modified Stark's (Misgav Ladach) caesarean section"", 'Misgav Ladach (ML) caesarean section']","['incidence of anemia and the need for blood transfusions', 'perioperative morbidity', 'Perioperative and postoperative complications', 'Postoperative febrility, dehiscence and wound seroma', 'paralytic ileus, uroinfections and bladder atony']","[{'cui': 'C0195619', 'cui_str': 'Classical cesarean section'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042019', 'cui_str': 'Catheterization, Urinary'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0406831', 'cui_str': 'Wound seroma'}, {'cui': 'C0030446', 'cui_str': 'Paralytic ileus'}, {'cui': 'C0403645', 'cui_str': 'Acontractile detrusor'}]",822.0,0.0173303,The use of antibiotics and analgesics was prolonged until the fifth postoperative day in the first group compared to the second group where it was reduced to only 10 % on the second day (p < 0.0005).,"[{'ForeName': 'Dubravko', 'Initials': 'D', 'LastName': 'Habek', 'Affiliation': 'University Department of Gynecology and Obstetrics, Clinical Hospital, Sveti Duh ""Zagreb, Croatian Catholic University Zagreb, Croatia. Electronic address: dubravko.habek@os.t-com.hr.'}, {'ForeName': 'Anis', 'Initials': 'A', 'LastName': 'Cerovac', 'Affiliation': 'Department of Gynecology and Obstetrics, General Hospital Tešanj, Bosnia and Herzegovina.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Luetić', 'Affiliation': 'University Department of Gynecology and Obstetrics, Clinical Hospital, Sveti Duh ""Zagreb, Croatian Catholic University Zagreb, Croatia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Marton', 'Affiliation': 'University Department of Gynecology and Obstetrics, Clinical Hospital, Sveti Duh ""Zagreb, Croatian Catholic University Zagreb, Croatia.'}, {'ForeName': 'Matija', 'Initials': 'M', 'LastName': 'Prka', 'Affiliation': 'University Department of Gynecology and Obstetrics, Clinical Hospital, Sveti Duh ""Zagreb, Croatian Catholic University Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Kulaš', 'Affiliation': 'University Department of Gynecology and Obstetrics, Clinical Hospital, Sveti Duh ""Zagreb, Croatian Catholic University Zagreb, Croatia.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Ujević', 'Affiliation': 'University Department of Gynecology and Obstetrics, Clinical Hospital, Sveti Duh ""Zagreb, Croatian Catholic University Zagreb, Croatia.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.02.026']
3054,32079968,Preliminary Effects of Tailoring an Obesity Prevention Intervention Program for Latino Immigrant Families.,"An obesity preventive intervention program for preschool families, Healthy Balance, was tested in 2 sequential pilot trials. The first pilot tested the original and translated group intervention in a heterogeneous population (65 families), and the second tested the feasibility of a culturally adapted version for Latinx immigrant families (27 families). No significant study 1 intervention effects were found. However, in study 2, there were significant improvements in parent body mass index, neck circumference, and blood pressure. These studies suggest that targeting family system change and tailoring the intervention for Latinx immigrant populations is feasible and has the potential to improve obesity-related biomarkers.",2020,No significant study 1 intervention effects were found.,"['Latinx immigrant families (27 families', 'Latino Immigrant Families', 'preschool families, Healthy Balance']","['obesity preventive intervention program', 'Tailoring an Obesity Prevention Intervention Program']","['parent body mass index, neck circumference, and blood pressure']","[{'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0120255,No significant study 1 intervention effects were found.,"[{'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Linville', 'Affiliation': 'University of Oregon, Eugene (Drs Linville, Martinez, and Shune and Ms Mintz and Mr Gau); and Oregon Research Institute, Eugene (Dr Stice).'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Mintz', 'Affiliation': ''}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Martinez', 'Affiliation': ''}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Gau', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Shune', 'Affiliation': ''}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000252']
3055,31323662,The effect of implantable cardioverter-defibrillator in patients with diabetes and non-ischaemic systolic heart failure.,"AIMS
Implantable cardioverter-defibrillator (ICD) implantation reduce the risk of sudden cardiac death, but not all-cause death in patients with non-ischaemic systolic heart failure (HF). Whether co-existence of diabetes affects ICD treatment effects is unclear.
METHODS AND RESULTS
We examined the effect of ICD implantation on risk of all-cause death, cardiovascular death, and sudden cardiac death (SCD) according to diabetes status at baseline in the Danish Study to Assess the Efficacy of ICDs in Patients with Non-ischaemic Systolic Heart Failure on Mortality (DANISH) trial. Outcomes were analysed by use of cumulative incidence curves and Cox regressions models. Of the 1116 patients enrolled, 211 (19%) had diabetes at baseline. Patients with diabetes were more obese, had worse kidney function and more were in New York Heart Association Class III/IV. The risk of device infections and other complications in the ICD group was similar among patients with and without diabetes (6.1% vs. 4.6% P = 0.54). Irrespective of treatment group, diabetes was associated with higher risk of all-cause death, cardiovascular death, and SCD. The treatment effect of ICD in patients with diabetes vs. patients without diabetes was hazard ratio (HR) = 0.92 (0.57-1.50) vs. HR = 0.85 (0.63-1.13); Pinteraction = 0.60 for all-cause mortality, HR = 0.99 (0.58-1.70) vs. HR = 0.70 (0.48-1.01); Pinteraction = 0.25 for cardiovascular death, and HR = 0.81 (0.35-1.88) vs. HR = 0.40 (0.22-0.76); Pinteraction = 0.16 for sudden cardiac death.
CONCLUSION
Among patients with non-ischaemic systolic HF, diabetes was associated with higher incidence of all-cause mortality, primarily driven by cardiovascular mortality including SCD. Treatment effect of ICD therapy was not significantly modified by diabetes which might be due to lack of power.",2019,"Patients with diabetes were more obese, had worse kidney function and more were in New York Heart Association Class III/IV.","['Patients with Non-ischaemic Systolic Heart Failure on Mortality (DANISH) trial', 'patients with non-ischaemic systolic heart failure (HF', 'patients with diabetes vs. patients without diabetes', 'patients with diabetes and non-ischaemic systolic heart failure', 'Patients with diabetes were more obese, had worse kidney function and more were in New York Heart Association Class III/IV', '1116 patients enrolled, 211 (19%) had diabetes at baseline']","['ICD', 'Implantable cardioverter-defibrillator (ICD) implantation', 'ICD therapy', 'implantable cardioverter-defibrillator', 'ICD implantation']","['risk of all-cause death, cardiovascular death, and sudden cardiac death (SCD', 'sudden cardiac death', 'higher risk of all-cause death, cardiovascular death, and SCD', 'risk of device infections and other complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",1116.0,0.0598233,"Patients with diabetes were more obese, had worse kidney function and more were in New York Heart Association Class III/IV.","[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Rørth', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Jens Jakob', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Korup', 'Affiliation': 'Department Health, Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis GroupInc., Boston, MA, USA.'}, {'ForeName': 'Niels E', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Clinical Medicine, Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Eiskjær', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Jesper Hastrup', 'Initials': 'JH', 'LastName': 'Svendsen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Dan E', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department Health, Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Steen', 'Initials': 'S', 'LastName': 'Pehrson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}, {'ForeName': 'Søren L', 'Initials': 'SL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euz114']
3056,31483743,Brief Relaxation Training for the Prevention of Stress-Related Difficulties: A Pilot Study.,,2020,,['Stress-Related Difficulties'],['Brief Relaxation Training'],[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]",[],,0.0176692,,"[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Okado', 'Affiliation': 'California State University, Fullerton, CA, USA.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'De Pace', 'Affiliation': 'California State University, Fullerton, CA, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ewing', 'Affiliation': ""Department of Psychology, Rady Children's Hospital in San Diego, CA, USA.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Rowley', 'Affiliation': 'Department of Psychology, University of Massachusetts Amherst, MA, USA.'}]",International quarterly of community health education,['10.1177/0272684X19873787']
3057,32533875,Improving oral health in nursing home residents: A process evaluation of a shared oral care intervention.,"AIMS AND OBJECTIVES
To evaluate the process of implementing an oral care intervention in nursing homes in a Danish municipality.
BACKGROUND
Older people with aged natural dentition require preventive and curative oral health care. An intervention based on principles of situated learning was implemented to establish closer cooperation between dental and nursing staff in nursing homes, leading to improved oral hygiene in nursing home residents.
DESIGN
An embedded multiple-case study combined with principles of realist evaluation unfolded in three phases: Formulation of initial programme theory, Testing and Refining the programme theory. The COREQ checklist is followed in reporting.
METHODS
Observations, six group interviews and 22 face-to-face interviews with dentists, dental practitioners, nursing home managers, care professionals and residents were conducted in three nursing homes (n = 41).
RESULTS
Three main outcomes of a programme theory were identified, relating to (a) residents, in the form of new oral care routines; (b) interdisciplinary working, in the form of professional pride in performing sufficient oral care; (c) organisational level changes, in the form of increased interdisciplinary knowledge sharing. The overarching supportive mechanisms were the creation of relationships between residents, dental practitioners and care professionals as well as nursing home management taking responsibility for structure, planning and knowledge sharing.
CONCLUSION
The situated learning perspective supported residents and care professionals' competencies in performing sufficient oral care. The shared oral care intervention supports an individual and multidisciplinary assessment of nursing home residents' ability to self-care concerning oral care. Contextual factors, supportive and restraining mechanisms influence the intervention's success.
RELEVANCE TO CLINICAL PRACTICE
Understanding the complexity within interdisciplinary cooperation in primary nursing and unravelling the necessary properties to enhance nursing home residents' oral health care are areas of improvement for care service in nursing homes.",2020,"An intervention based on principles of situated learning was implemented to establish closer cooperation between dental and nursing staff in nursing homes, leading to improved oral hygiene in nursing home residents.
","['Older people with aged natural dentition require preventive and curative oral health care', 'Observations, six group interviews and 22 face-to-face interviews with dentists, dental practitioners, nursing home managers, care professionals and residents were conducted in three nursing homes (n\xa0=\xa041', 'nursing home residents']",['oral care intervention'],[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0011443', 'cui_str': 'Dentition'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0335141', 'cui_str': 'Manager'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.017391,"An intervention based on principles of situated learning was implemented to establish closer cooperation between dental and nursing staff in nursing homes, leading to improved oral hygiene in nursing home residents.
","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Aagaard', 'Affiliation': 'Department of Health Science and Technology, Public Health and Epidemiology Group, Aalborg University, Aalborg Øst, Denmark.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Meléndez-Torres', 'Affiliation': 'Peninsula Technology Assessment Group, College of Medicine and Health, University of Exeter, Exeter, England.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Overgaard', 'Affiliation': 'Department of Health Science and Technology, Public Health and Epidemiology Group, Aalborg University, Aalborg Øst, Denmark.'}]",Journal of clinical nursing,['10.1111/jocn.15373']
3058,32089486,Objective and Subjective Measures of Premature Ejaculation: How Closely Do They Correspond and How Well Are the Subjective Measures Recalled?,"BACKGROUND
Clinical trials evaluating new treatments for premature ejaculation (PE) should ideally include both objective end points and patient reported outcomes (PROs), but there is no consensus currently over the optimal measures or combination of outcomes. In addition, many PROs use a 1-month recall period, despite concerns about potential recall bias.
AIMS
Data from a clinical trial of men with lifelong PE were used to examine the consistency of 2 core items of the Premature Ejaculation Profile (PEP), a widely used PRO for assessing subjective aspects of PE. The specific aim was to assess the level of agreement between the original 1-month recall version compared with a new event-based version of the scale in men meeting current definitions of lifelong PE. A further aim was to investigate the convergent validity between an objective end point of intravaginal ejaculatory latency time (IELT), subjective PEP responses, and a patient's Clinical Global Impression of Change (CGIC) measure.
METHODS
For assessment of consistency of PEP responses (short-term [ie, sexual event driven] vs 1-month recall), descriptive statistics, correlation coefficients (Pearson and Spearman), and Bland-Altman plots are presented for each time interval. For assessment of convergent validity, descriptive statistics and correlation coefficients (Pearson and Spearman) are presented for each assessment with geometric mean IELT values. Results are also depicted graphically. Geometric mean IELT over the last 4 weeks of treatment and change from baseline (absolute and fold change) were estimated via a general linear model for each category of change in PEP and CGIC, adjusting for baseline IELT.
OUTCOMES
PEP items administered via 1-month recall and short-term event-driven responses gave virtually identical results. There was a strong correlation (very good convergent validity) between IELT and responses to PEP and the CGIC.
CLINICAL TRANSLATION
Men with lifelong PE can accurately recall their level of sexual functioning over the previous month. The PEP and CGIC are appropriate instruments to measure the subjective response of men with PE to new treatments.
STRENGTHS AND LIMITATIONS
Our analyses address gaps in previously published research on PE assessment methodology. Men with acquired PE, men without partners, and men in homosexual relationships were not studied.
CONCLUSIONS
In a clinical trial setting, PEP and CGIC are appropriate end points and are likely the optimal combination of PROs for use with IELT to enable a global assessment of patient response to new PE treatments. Althof S, Rosen R, Harty B, et al. Objective and Subjective Measures of Premature Ejaculation: How Closely Do They Correspond and How Well Are the Subjective Measures Recalled? J Sex Med 2020;17:634-644.",2020,"There was a strong correlation (very good convergent validity) between IELT and responses to PEP and the CGIC.
","['Premature Ejaculation', 'men meeting current definitions of lifelong PE', 'premature ejaculation (PE', 'Men with lifelong PE', 'men with lifelong PE']",[],"['Geometric mean IELT', 'PEP responses', 'PEP items administered via 1-month recall and short-term event-driven responses', 'J Sex Med', ""intravaginal ejaculatory latency time (IELT), subjective PEP responses, and a patient's Clinical Global Impression of Change (CGIC) measure""]","[{'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0416951,"There was a strong correlation (very good convergent validity) between IELT and responses to PEP and the CGIC.
","[{'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Althof', 'Affiliation': 'Case Western Reserve University Medical School, Cleveland, OH, USA; Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA. Electronic address: sxa6@case.edu.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Harty', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Osterloh', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Muirhead', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McMahon', 'Affiliation': 'Australian Centre for Sexual Health, St. Leonards, NSW, Australia.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.01.002']
3059,32274665,"Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy.","PURPOSE
Sexual dysfunction is an important concern of premenopausal women with early breast cancer. We investigated predictors of sexual problems in two randomized controlled trials.
METHODS
A subset of patients enrolled in TEXT and SOFT completed global and symptom-specific quality-of-life indicators, CES-Depression and MOS-Sexual Problems measures at baseline, six, 12 and 24 months. Mixed models tested the association of changes in treatment-induced symptoms (baseline to 6 months), depression at 6 months, and age at randomization with changes in sexual problems over 2 years.
RESULTS
Sexual problems increased by 6 months and persisted at this level. Overall, patients with more severe worsening of vaginal dryness, sleep disturbances and bone or joint pain at 6 months reported a greater increase in sexual problems at all time-points. Depression scores were significantly associated with sexual problems in the short-term. All other symptoms had a smaller impact on sexual problems. Age was not associated with sexual problems at any time-point.
CONCLUSION
Among several key symptoms, vaginal dryness, sleep disturbance, and bone and joint pain significantly predicted sexual problems during the first 2 years. Early identification of these symptoms may contribute to timely and tailored interventions.",2020,"Overall, patients with more severe worsening of vaginal dryness, sleep disturbances and bone or joint pain at 6 months reported a greater increase in sexual problems at all time-points.","['premenopausal women with early breast cancer', 'premenopausal women with early breast cancer receiving adjuvant endocrine therapy']",[],"['sexual problems', 'Sexual problems', 'Depression scores', 'severe worsening of vaginal dryness, sleep disturbances and bone or joint pain', 'SOFT completed global and symptom-specific quality-of-life indicators, CES-Depression and MOS-Sexual Problems measures', 'vaginal dryness, sleep disturbance, and bone and joint pain']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]",[],"[{'cui': 'C0856619', 'cui_str': 'Sexual problem'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0241633', 'cui_str': 'Vaginal dryness'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0230191,"Overall, patients with more severe worsening of vaginal dryness, sleep disturbances and bone or joint pain at 6 months reported a greater increase in sexual problems at all time-points.","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ribi', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Effingerstrasse 40, 3008, Bern, Switzerland. karin.ribi@ibcsg.org.'}, {'ForeName': 'Weixiu', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Walley', 'Affiliation': 'University of Calgary and Canadian Cancer Trials Group, Calgary, AB, Canada.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Jacquie', 'Initials': 'J', 'LastName': 'Chirgwin', 'Affiliation': 'Box Hill and Maroondah Hospitals, Monash University, Clayton, VIC, Australia.'}, {'ForeName': 'Rafat H', 'Initials': 'RH', 'LastName': 'Ansari', 'Affiliation': 'Norther Indiana Cancer Research Consortium, South Bend, USA.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Salim', 'Affiliation': 'Allan Blair Cancer Center, Regina, SK, Canada.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'van der Westhuizen', 'Affiliation': 'Breast Cancer Trials Australia & New Zealand, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Ehtesham', 'Initials': 'E', 'LastName': 'Abdi', 'Affiliation': 'The Tweed Hospital, Griffith University Gold Coast, Tweed Heads, NSW, Australia.'}, {'ForeName': 'Prudence A', 'Initials': 'PA', 'LastName': 'Francis', 'Affiliation': 'Breast Cancer Trials Australia & New Zealand, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chia', 'Affiliation': 'BCCA-Vancouver Cancer Center, Vancouver, BC, Canada.'}, {'ForeName': 'Vernon J', 'Initials': 'VJ', 'LastName': 'Harvey', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Gini F', 'Initials': 'GF', 'LastName': 'Fleming', 'Affiliation': 'The University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Pagani', 'Affiliation': 'Institute of Oncology of Southern Switzerland, Geneva University Hospitals, Swiss Group for Clinical Cancer Research (SAKK), Lugano Viganello, Switzerland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': 'Hospital of Prato-AUSL Toscana Centro and International Breast Cancer Study Group, Prato, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Effingerstrasse 40, 3008, Bern, Switzerland.'}, {'ForeName': 'Alan S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Effingerstrasse 40, 3008, Bern, Switzerland.'}, {'ForeName': 'Meredith M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jürg', 'Initials': 'J', 'LastName': 'Bernhard', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Effingerstrasse 40, 3008, Bern, Switzerland.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05622-5']
3060,33263702,Statistical analysis plan for the Balanced Solution versus Saline in Intensive Care Study (BaSICS).,"OBJECTIVE
To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).
METHODS
BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure.
RESULTS
BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days.
CONCLUSION
This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.",2020,"Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days.
",['critically ill patients'],"['Balanced Solution versus Saline', 'Balanced Solutions versus Saline', 'Plasma-Lyte 148 versus 0.9% saline']","['90-day mortality', 'renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205415', 'cui_str': 'Balanced'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0071208', 'cui_str': 'Plasma-lyte 148'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.353933,"Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days.
","[{'ForeName': 'Lucas Petri', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Alexandre Biasi', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Rodrigo Santos', 'Initials': 'RS', 'LastName': 'Biondi', 'Affiliation': 'Instituto de Cardiologia do Distrito Federal, Fundação Universitária de Cardiologia - Brasília (DF), Brasil.'}, {'ForeName': 'Flávio Geraldo Rezende de', 'Initials': 'FGR', 'LastName': 'Freitas', 'Affiliation': 'Hospital e Maternidade Sepaco - São Paulo (SP), Brasil.'}, {'ForeName': 'Rodrigo Cruvinel', 'Initials': 'RC', 'LastName': 'Figueiredo', 'Affiliation': 'Hospital e Maternidade São José - Colatina (ES), Brasil.'}, {'ForeName': 'Wilson José', 'Initials': 'WJ', 'LastName': 'Lovato', 'Affiliation': 'Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo - Ribeirão Preto (SP), Brasil.'}, {'ForeName': 'Cristina Prata', 'Initials': 'CP', 'LastName': 'Amêndola', 'Affiliation': 'Hospital de Amor - Barretos (SP), Brasil.'}, {'ForeName': 'Ary', 'Initials': 'A', 'LastName': 'Serpa Neto', 'Affiliation': 'Hospital Israelita Albert Einstein - São Paulo (SP), Brasil.'}, {'ForeName': 'Jorge Luiz da Rocha', 'Initials': 'JLDR', 'LastName': 'Paranhos', 'Affiliation': 'Santa Casa de Misericórdia de São João Del-Rei - São João Del-Rei (MG), Brasil.'}, {'ForeName': 'Viviane Cordeiro', 'Initials': 'VC', 'LastName': 'Veiga', 'Affiliation': 'BP - A Beneficência Portuguesa de São Paulo - São Paulo (SP).'}, {'ForeName': 'Marco Antonio Vieira', 'Initials': 'MAV', 'LastName': 'Guedes', 'Affiliation': 'Hospital Ana Nery - Salvador (BA), Brasil.'}, {'ForeName': 'Eraldo de Azevedo', 'Initials': 'EA', 'LastName': 'Lúcio', 'Affiliation': 'Hospital São Francisco, Santa Casa de Misericórdia de Porto Alegre - Porto Alegre (RS), Brasil.'}, {'ForeName': 'Lúcio Couto', 'Initials': 'LC', 'LastName': 'Oliveira Júnior', 'Affiliation': 'Hospital Geral Cleriston Andrade - Feira de Santana (BA), Brasil.'}, {'ForeName': 'Thiago Costa', 'Initials': 'TC', 'LastName': 'Lisboa', 'Affiliation': 'Hospital Santa Rita, Santa Casa de Misericórdia de Porto Alegre - Porto Alegre (RS), Brasil.'}, {'ForeName': 'Fabio Holanda', 'Initials': 'FH', 'LastName': 'Lacerda', 'Affiliation': 'Hospital da Luz - São Paulo (SP), Brasil.'}, {'ForeName': 'Tamiris Abait', 'Initials': 'TA', 'LastName': 'Miranda', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}, {'ForeName': 'Israel Silva', 'Initials': 'IS', 'LastName': 'Maia', 'Affiliation': 'Hospital Nereu Ramos - Florianópolis (SC), Brasil.'}, {'ForeName': 'Cintia Magalhães Carvalho', 'Initials': 'CMC', 'LastName': 'Grion', 'Affiliation': 'Hospital Universitário Regional do Norte do Paraná - Londrina (PR), Brasil.'}, {'ForeName': 'Flavia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Hospital São Paulo, Escola Paulista de Medicina, Universidade Federal de São Paulo - São Paulo (SP), Brasil.'}, {'ForeName': 'Fernando Godinho', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': 'Instituto de Pesquisa, HCor-Hospital do Coração - São Paulo (SP), Brasil.'}]",Revista Brasileira de terapia intensiva,['10.5935/0103-507X.20200081']
3061,33250068,Outpatient physiotherapy versus home-based rehabilitation for patients at risk of poor outcomes after knee arthroplasty: CORKA RCT.,"BACKGROUND
Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes.
OBJECTIVES
To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty.
DESIGN
An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study.
SETTING
The trial took place in 14 NHS physiotherapy departments.
PARTICIPANTS
People identified as being at high risk of a poor outcome after knee arthroplasty.
INTERVENTIONS
A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy.
MAIN OUTCOME MEASURES
The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries.
RESULTS
In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points; p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold.
LIMITATIONS
The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded.
CONCLUSIONS
This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN13517704.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.",2020,Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant).,"['14 NHS physiotherapy departments', '621 participants were randomised', 'patients at risk of poor outcomes after knee arthroplasty', '309 participants', '312 participants', 'People identified as being at high risk of a poor outcome after knee arthroplasty']","['CORKA intervention', 'Outpatient physiotherapy versus home-based rehabilitation', 'traditional outpatient physiotherapy model with those from a home-based rehabilitation programme', 'home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model', 'COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme']","['Total societal costs (combining health-care costs and other costs', 'Late Life Function and Disability Instrument function total score', 'Late Life Function and Disability Instrument', 'Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance']","[{'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0587975', 'cui_str': 'Physiotherapy department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",621.0,0.0926772,Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant).,"[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Room', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Toye', 'Affiliation': 'Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kent', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Kenealy', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Schussel', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Collins', 'Affiliation': 'Centre for Statistics in Medicine, Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Drummond', 'Affiliation': 'School of Health Sciences, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Cook', 'Affiliation': 'Patient and public involvement member.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24650']
3062,33250038,Renal Safety of Multimodal Brain Imaging Followed by Endovascular Therapy.,"BACKGROUND AND PURPOSE
Contrast-enhanced noninvasive angiography and perfusion imaging are recommended to identify eligible patients for endovascular therapy (EVT) in extended time windows (>6 hours or wake-up). If eligible, additional intraarterial contrast exposure will occur during EVT. We aimed to study the renal safety in the DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke) population, selected with contrast-enhanced multimodal Imaging and randomized to EVT versus medical management.
METHODS
In the randomized DEFUSE 3 trial population, we compared changes in serum creatinine between baseline (before randomization) and 24 hours later. The primary outcome was the relative change in creatinine level between baseline and 24 hours in the EVT versus medical arm. The secondary outcome was a comparison between computed tomography (CT) versus magnetic resonance imaging selection in the EVT arm. The safety outcome was a comparison of the proportion of patients with criteria for contrast-associated kidney injury in the EVT versus medical arm and a comparison between CT versus magnetic resonance imaging selection in the EVT arm.
RESULTS
In the DEFUSE 3 population (n=182, age 69±13, 51% female), mean creatinine decreased from a baseline of 0.98±0.33 mg/dL to 0.88±0.28 mg/dL at 24 hours ( P <0.001). There was no difference in change between treatment groups: relative to baseline, there was a 6.3% reduction in the EVT group versus 9.2% in the medical group, P =0.294. Absolute decrease -0.08±0.18 in EVT versus -0.12±0.18 in medical, P =0.135; Among patients treated with EVT, there was no difference in 24-hour creatinine level changes between patients who were selected with CT angiography/CT perfusion (-0.08±0.18) versus magnetic resonance imaging (-0.07±0.19), P =0.808 or 6.8% reduction versus 4.8%, P =0.696. In the EVT arm, contrast-associated kidney injury was encountered in 4 out of 91 (4.4%) versus 2/90 (2.2%) in the medical arm P =0.682. In the EVT arm, contrast-associated kidney injury was evenly distributed between magnetic resonance imaging (1/22, 4.6%) versus CT 3 out of 69 (4.4%), P =1.0.
CONCLUSIONS
Perfusion imaging before EVT was not associated with evidence of decline in renal function.
REGISTRATION
URL: https://www.clinicaltrials.gov. Unique identifier: NCT02586415.",2020,"There was no difference in change between treatment groups: relative to baseline, there was a 6.3% reduction in the EVT group versus 9.2% in the medical group, P =0.294.",['eligible patients for endovascular therapy (EVT) in extended time windows '],"['DEFUSE 3 (Endovascular Therapy', 'Multimodal Brain Imaging Followed by Endovascular Therapy', 'computed tomography (CT', 'EVT']","['kidney injury', 'serum creatinine', 'relative change in creatinine level', 'renal safety', 'mean creatinine', '24-hour creatinine level changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557702', 'cui_str': 'Window'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0160420', 'cui_str': 'Injury of kidney'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.106145,"There was no difference in change between treatment groups: relative to baseline, there was a 6.3% reduction in the EVT group versus 9.2% in the medical group, P =0.294.","[{'ForeName': 'Carlo W', 'Initials': 'CW', 'LastName': 'Cereda', 'Affiliation': 'Stroke Center EOC, Neurocenter of Southern Switzerland, Lugano (C.W.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Stanford Stroke Center, Stanford University School of Medicine, CA. (M.M., S.K., M.G.L., G.W.A.).'}, {'ForeName': 'Pietro E', 'Initials': 'PE', 'LastName': 'Cippà', 'Affiliation': 'Division of Nephrology, EOC, Lugano, Switzerland (P.E.C.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Kemp', 'Affiliation': 'Stanford Stroke Center, Stanford University School of Medicine, CA. (M.M., S.K., M.G.L., G.W.A.).'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Heit', 'Affiliation': 'Department of Radiology, Stanford University School of Medicine, CA. (J.J.H., M.P.M.).'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Marks', 'Affiliation': 'Department of Radiology, Stanford University School of Medicine, CA. (J.J.H., M.P.M.).'}, {'ForeName': 'Maarten G', 'Initials': 'MG', 'LastName': 'Lansberg', 'Affiliation': 'Stanford Stroke Center, Stanford University School of Medicine, CA. (M.M., S.K., M.G.L., G.W.A.).'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University School of Medicine, CA. (M.M., S.K., M.G.L., G.W.A.).'}]",Stroke,['10.1161/STROKEAHA.120.030816']
3063,33249802,Efficacy and safety of ustekinumab in East Asian patients with moderately to severely active ulcerative colitis: a subpopulation analysis of global phase 3 induction and maintenance studies (UNIFI).,"Background/Aims
We aimed to evaluate the efficacy and safety of ustekinumab (UST) in the East-Asian population with moderate to severely active ulcerative colitis (UC).
Methods
This sub-analysis was conducted on data from East-Asian patients included in the UNIFI program (NCT02407236). UNIFI consisted of two double-blind, placebo-controlled trials: an 8-week induction study and a 44-week randomized withdrawal maintenance study.
Results
Of 133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study. In the maintenance study, 78 patients were randomized. Patients who received UST 130 mg and UST 6 mg/kg showed numerically higher clinical remission at week 8 in the induction study (5/44 [11.4%] and 5/45 [11.1%], respectively) compared with those who received placebo (0/44, 0%). The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%). Serious adverse events were reported in 1 patient in UST 130 mg group, but no patient in UST 6 mg/kg group through week 8 in the induction study, and 1 patient in UST 90 mg q12w group and 5 patients in the UST 90 mg q8w group in the maintenance study. No deaths were reported in East-Asian patients throughout the study.
Conclusions
UST induction and maintenance treatments were effective in East-Asian patients with moderate to severe UC; the efficacy and safety profiles were consistent with the overall population.",2020,"The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%).","['East-Asian population with moderate to severely active ulcerative colitis (UC', 'East-Asian patients with moderate to severe UC', '133 East-Asian patients (Japanese: 107, Korean: 26) who underwent randomization, 131 completed induction study and 111 entered maintenance study', '78 patients were randomized', 'East Asian patients with moderately to severely active ulcerative colitis', 'East-Asian patients included in the UNIFI program (NCT02407236']","['UST 130 mg and UST', 'UST', 'ustekinumab (UST', 'placebo', 'ustekinumab']","['proportion of patients achieved clinical remission', 'Efficacy and safety', 'clinical remission', 'deaths', 'Serious adverse events']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.152079,"The proportion of patients achieved clinical remission at week 44 was numerically higher in the UST 90 mg q12w group (10/21, 47.6%), but similar in the UST 90 mg q8w group (5/26, 19.2%) compared to placebo (7/31, 22.6%).","[{'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hyo Jong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': ""Center for Crohn's and Colitis, Department of Gastroenterology, Kyung Hee University College of Medicine, Seoul, Korea.""}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Motoya', 'Affiliation': 'IBD Center, Hokkaido Prefectural Welfare Federation of Agricultural Cooperative, Sapporo-Kosei General, Hokkaido, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan.'}, {'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Ohnishi', 'Affiliation': 'Division of Gastroenterology, Shizuoka Medical Center, Shizuoka, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Fujii', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Nobuko', 'Initials': 'N', 'LastName': 'Matsushima', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Richuan', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Colleen W', 'Initials': 'CW', 'LastName': 'Marano', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}]",Intestinal research,['10.5217/ir.2020.00080']
3064,33249759,The differential relationship of an afterschool physical activity intervention on brain function and cognition in children with obesity and their normal weight peers.,"BACKGROUND
Physical activity (PA) is beneficial for cognitive and brain health during preadolescence. Given that childhood obesity (OB) is a public health concern, investigating this effect in children with OB is an important societal consideration.
OBJECTIVES
To identify the effects of weight status and PA on neuroelectric indices of executive function in preadolescence.
METHODS
Children were randomly assigned to a PA intervention or a wait-list control group and completed a task that manipulated inhibitory control, while task performance and neuroelectric (P3 component) outcomes were assessed. About 103 children with OB were matched to a sample of 103 normal weight (NW) children based on treatment allocation and demographic variables.
RESULTS
Children with OB in the control group demonstrated reduced P3 amplitude from pre- to post-test, meanwhile those with OB in the PA intervention maintained P3 amplitude at post-test compared to pre-test. Additionally, NW children in the PA intervention group showed that decreased visceral adipose tissue corresponded with faster task performance, a relationship not observed in children with OB.
CONCLUSIONS
These results suggest that a 9-month PA intervention may be particularly beneficial to the cognitive and brain health of children with OB. These results are important to consider given the public health concerns associated with childhood OB.",2020,"RESULTS
Children with OB in the control group demonstrated reduced P3 amplitude from pre- to post-test, meanwhile those with OB in the PA intervention maintained P3 amplitude at post-test compared to pre-test.","['children with OB', 'children with obesity and their normal weight peers', '103 children with OB were matched to a sample of 103 normal weight (NW) children based on treatment allocation and demographic variables', 'Children']","['PA intervention or a wait-list control group and completed a task that manipulated inhibitory control', 'Physical activity (PA', 'afterschool physical activity intervention', 'PA intervention']","['visceral adipose tissue', 'brain function and cognition', 'reduced P3 amplitude']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",103.0,0.0215299,"RESULTS
Children with OB in the control group demonstrated reduced P3 amplitude from pre- to post-test, meanwhile those with OB in the PA intervention maintained P3 amplitude at post-test compared to pre-test.","[{'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Logan', 'Affiliation': 'Northeastern University, Department of Psychology, Boston, MA, USA.'}, {'ForeName': 'Lauren B', 'Initials': 'LB', 'LastName': 'Raine', 'Affiliation': 'Northeastern University, Department of Psychology, Boston, MA, USA.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Drollette', 'Affiliation': 'University of North Carolina at Greensboro, Department of Kinesiology, Greensboro, North Carolina, USA.'}, {'ForeName': 'Darla M', 'Initials': 'DM', 'LastName': 'Castelli', 'Affiliation': 'University of Texas at Austin, Department of Kinesiology and Health Education, Austin, Texas, USA.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'University of Illinois at Urbana-Champaign, Department of Kinesiology and Community Health, Urbana, Illinois, USA.'}, {'ForeName': 'Arthur F', 'Initials': 'AF', 'LastName': 'Kramer', 'Affiliation': 'Northeastern University, Department of Psychology, Boston, MA, USA.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Northeastern University, Department of Psychology, Boston, MA, USA.'}]",Pediatric obesity,['10.1111/ijpo.12708']
3065,33249735,Sweetness Perception is not Involved in the Regulation of Blood Glucose after Oral Application of Sucrose and Glucose Solutions in Healthy Male Subjects.,"SCOPES
This study investigated the effect of the sweetness of a sucrose versus an isocaloric glucose solution in dietary concentrations on blood glucose regulation by adjusting the sweetness level using the sweet taste inhibitor lactisole.
METHODS AND RESULTS
A total of 27 healthy males participated in this randomized, crossover study with four treatments: 10% glucose, 10% sucrose, 10%sucrose + 60 ppm lactisole, and 10% glucose + 60 ppm lactisole. Plasma glucose, insulin, GLP-1, and glucagon levels were measured at baseline and 15, 30, 60, 90, and 120 min after beverage consumption. Test subjects rated the sucrose solution to be sweeter than the isocaloric glucose solution, whereas no difference in sweetness was reported after addition of lactisole to the sucrose solution. Administration of the less sweet glucose solution versus sucrose led to higher blood glucose levels after 30 min, as reflected by a lower ΔAUC for sucrose (1072 ± 136) than for glucose (1567 ± 231). Application of lactisole did not lead to differences in glucose, insulin, or glucagon responses induced by sucrose or glucose.
CONCLUSION
The results indicate that the structure of the carbohydrate has a stronger impact on the regulation of blood glucose levels than the perceived sweetness. This article is protected by copyright. All rights reserved.",2020,"Application of lactisole did not lead to differences in glucose, insulin, or glucagon responses induced by sucrose or glucose.
","['27 healthy males', 'Healthy Male Subjects']","['10% glucose, 10% sucrose, 10%sucrose + 60\xa0ppm lactisole, and 10% glucose + 60\xa0ppm lactisole', 'sweet glucose solution versus sucrose', 'sucrose versus an isocaloric glucose solution']","['blood glucose regulation', 'blood glucose levels', 'glucose, insulin, or glucagon responses', 'Plasma glucose, insulin, GLP-1, and glucagon levels']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C1564960', 'cui_str': 'lactisole'}, {'cui': 'C0085077', 'cui_str': 'Acute febrile neutrophilic dermatosis'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}]",27.0,0.0488191,"Application of lactisole did not lead to differences in glucose, insulin, or glucagon responses induced by sucrose or glucose.
","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Grüneis', 'Affiliation': 'V.\xa0Grüneis, C. Galassi, C. M. Karl, J. Treml, B. Lieder, Christian Doppler Laboratory for Taste Research, Faculty of Chemistry, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schweiger', 'Affiliation': 'K. Schweiger, V. Somoza, B. Lieder, Department of Physiological Chemistry, Faculty of Chemistry, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Galassi', 'Affiliation': 'V.\xa0Grüneis, C. Galassi, C. M. Karl, J. Treml, B. Lieder, Christian Doppler Laboratory for Taste Research, Faculty of Chemistry, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}, {'ForeName': 'Corinna M', 'Initials': 'CM', 'LastName': 'Karl', 'Affiliation': 'V.\xa0Grüneis, C. Galassi, C. M. Karl, J. Treml, B. Lieder, Christian Doppler Laboratory for Taste Research, Faculty of Chemistry, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Treml', 'Affiliation': 'V.\xa0Grüneis, C. Galassi, C. M. Karl, J. Treml, B. Lieder, Christian Doppler Laboratory for Taste Research, Faculty of Chemistry, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}, {'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Ley', 'Affiliation': 'J. P. Ley, G. E. Krammer, Symrise AG, Muehlenfeldstrasse 1, Holzminden, 37603, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'J. König, Department of Nutritional Science, Faculty of Life Sciences, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}, {'ForeName': 'Gerhard E', 'Initials': 'GE', 'LastName': 'Krammer', 'Affiliation': 'J. P. Ley, G. E. Krammer, Symrise AG, Muehlenfeldstrasse 1, Holzminden, 37603, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Somoza', 'Affiliation': 'K. Schweiger, V. Somoza, B. Lieder, Department of Physiological Chemistry, Faculty of Chemistry, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lieder', 'Affiliation': 'V.\xa0Grüneis, C. Galassi, C. M. Karl, J. Treml, B. Lieder, Christian Doppler Laboratory for Taste Research, Faculty of Chemistry, University of Vienna, Althanstrasse 14, Vienna, 1090, Austria.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000472']
3066,33249712,A comparative study on the use of Fractional Co2 laser with Tacrolimus or Calcipotriol or NB-UVB in treatment of stable non segmental vitiligo.,"BACKGROUND
Conventional methods of treatment for vitiligo are often unsatisfactory to the patients and time consuming, new treatment modalities are needed.
AIM
To evaluate the efficacy and safety of fractional carbon dioxide (CO2) laser therapy followed by narrow band ultraviolet-B (NB-UVB) phototherapy, topical tacrolimus or topical calcipotriol on stable non segmental vitiligo.
PATIENTS AND METHODS
Thirty patients with stable non segmental vitiligo were evaluated. All patients were subjected to three sessions of fractional CO2 laser one month apart. Patients were divided into three groups (each group 10 patients). Group (A) treated with tacrolimus ointment twice daily for 3 months, Group (B) treated with Calcipotriol ointment twice daily for 3 months and Group (C) treated with NB-UVB twice weekly for 3 months. Outcomes were evaluated by calculating VASI score change, percentage of repigmentation, patient satisfaction, and adverse effects.
RESULTS
There was a statistical significant decrease in VASI score after treatment in the three groups. The VASI change and % of regimentation was higher in group (C) treated by laser and NB-UVB and this was significantly higher than group (B) treated with laser and calcipotriol. Otherwise there was no statistical significant difference between other treatment groups.
CONCLUSIONS
NB-UVB phototherapy, topical tacrolimus or topical calcipotriol in combination with fractional CO2 laser could be used effectively and safely as an alternative modality for treatment of vitiligo. The combination of fractional CO2 laser and NB-UVB was found to be more effective. This article is protected by copyright. All rights reserved.",2020,The VASI change and % of regimentation was higher in group (C) treated by laser and NB-UVB and this was significantly higher than group (B) treated with laser and calcipotriol.,"['Thirty patients with stable non segmental vitiligo were evaluated', 'stable non segmental vitiligo']","['fractional CO2 laser', 'fractional CO2 laser and NB-UVB', 'NB-UVB phototherapy, topical tacrolimus or topical calcipotriol', 'tacrolimus ointment', 'Calcipotriol ointment twice daily for 3 months and Group (C) treated with NB-UVB', 'fractional carbon dioxide (CO2) laser therapy followed by narrow band ultraviolet-B (NB-UVB) phototherapy, topical tacrolimus or topical calcipotriol', 'Fractional Co2 laser with Tacrolimus or Calcipotriol or NB-UVB']","['VASI score change, percentage of repigmentation, patient satisfaction, and adverse effects', 'VASI change and % of regimentation', 'VASI score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1274648', 'cui_str': 'Segmental vitiligo'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0939241', 'cui_str': 'Tacrolimus-containing product in cutaneous dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C1253468', 'cui_str': 'Tacrolimus Topical Ointment'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",30.0,0.0179251,The VASI change and % of regimentation was higher in group (C) treated by laser and NB-UVB and this was significantly higher than group (B) treated with laser and calcipotriol.,"[{'ForeName': 'Radwa M', 'Initials': 'RM', 'LastName': 'Bakr', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assuit University, Assuit, Egypt.'}, {'ForeName': 'Reham M', 'Initials': 'RM', 'LastName': 'Abdel-Gaber', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assuit University, Assuit, Egypt.'}, {'ForeName': 'Yasmin M', 'Initials': 'YM', 'LastName': 'Tawfik', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Assuit University, Assuit, Egypt.'}]",Dermatologic therapy,['10.1111/dth.14604']
3067,33249580,Migraine Headache Day Response Rates and the Implications to Patient Functioning: An Evaluation of 3 Randomized Phase 3 Clinical Trials of Galcanezumab in Patients With Migraine.,"OBJECTIVE
This post hoc study investigated the relationship between patient response in terms of migraine headache day reduction and patient-reported outcomes of health-related quality of life (HRQoL) and disability categories.
BACKGROUND
Migraine causes considerable disease-related disability and negatively impacts HRQoL of patients. Calcitonin gene-related peptide inhibitors improve these outcomes and may eliminate disability due to migraine in some patients.
METHODS
Analyses used data from 3 double-blind, placebo (PBO)-controlled, phase 3 studies in adults with episodic migraine (EM) (EVOLVE-1: N = 858 and EVOLVE-2: N = 915) or chronic migraine (CM) (REGAIN: N = 1113). Patients were randomized 2:1:1 to subcutaneous injection of PBO, galcanezumab (GMB) 120 mg, or GMB 240 mg once monthly for 6 months in EVOLVE-1 and -2 and for 3 months in REGAIN. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Patients were divided into 4 response-level groups based on percent change from baseline (<30%, ≥30% to <50%, ≥50% to <75%, ≥75%). Patient-reported outcomes included the 14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire.
RESULTS
Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response. On a 100-pt scale, increases in Role Function-Restrictive score in EM were 16.8 and 36.0 at the <30% and ≥75% response levels, respectively, and for CM were 10.7 and 46.5. Similar patterns in scores were observed for the Role Function-Preventive and Emotional Function domains. Examination of improvement in MSQ item score by treatment group showed that, in patients with EM, approximately 10 to 20% more GMB-treated patients (N = 796 for GMB 120 mg and GMB 240 mg) had improvements in all 14 MSQ items compared with PBO-treated patients (N = 773) (all P < .001). In patients with CM, 3 to 16% more GMB-treated patients (N = 507) had improvements in the 14 MSQ items compared with PBO (N = 494), though differences were statistically significant in only 19 of 28 comparisons. At baseline, mean MIDAS scores (EM, 33.1; CM, 67.2) indicated severe mean disability for patients with EM and very severe disability for patients with CM. Among patients with EM, 215 of 425 (50.6%) of those treated with GMB 120 mg and 212 of 413 (51.3%) treated with 240 mg had little/no disability due to migraine after 6 months (PBO: 277 of 832 (33.3%), P < .001 for both). Among patients with CM, 50 of 254 (19.7%) of those treated with GMB 120 mg and 54 of 258 (20.9%) treated with 240 mg reached the level of little/no disability after 3 months of treatment (PBO: 70 of 504 (13.9%), P = .045 for 120 mg, P = .017 for 240 mg).
CONCLUSIONS
Because migraine greatly impairs an individual's ability to participate in activities of daily living, measurements of HRQoL are essential in clinical research. This study showed that function in daily life, as measured by MSQ score, improved as migraine headache days were reduced and that GMB-treated patients were more likely to see improvement in MSQ item scores compared with PBO-treated patients. Elimination of migraine-related disability was also more frequent in GMB-treated patients compared with placebo-treated patients.",2020,"Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response.","['Patients With Migraine', 'Patient Functioning', 'adults with episodic migraine (EM) ']","['subcutaneous injection of PBO, galcanezumab (GMB', 'placebo', 'EVOLVE-1', 'Calcitonin', 'chronic migraine (CM', 'Galcanezumab', 'placebo (PBO)-controlled', 'GMB']","['MSQ item scores', 'overall mean change from baseline in monthly migraine headache days', 'Elimination of migraine-related disability', 'Migraine Headache Day Response Rates', 'severe mean disability', 'MSQ domain scores', 'Role Function-Restrictive score in EM', 'MSQ item score', 'migraine headache days', 'mean MIDAS scores', 'MSQ score', '14-item Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ) and Migraine Disability Assessment (MIDAS) questionnaire', 'severe disability', 'level of little/no disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}, {'cui': 'C0006668', 'cui_str': 'Calcitonin'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C1309950', 'cui_str': 'GOLPH3 protein, human'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}]",1113.0,0.0741682,"Among patients with migraine, mean improvements from baseline in MSQ domain scores increased with each successive level of migraine headache day response.","[{'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kurth', 'Affiliation': 'Institute of Public Health, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Amaal J', 'Initials': 'AJ', 'LastName': 'Starling', 'Affiliation': 'Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Ayer', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Wietecha', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Martha D', 'Initials': 'MD', 'LastName': 'Port', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Mallikarjuna', 'Initials': 'M', 'LastName': 'Rettiganti', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}, {'ForeName': 'Dustin D', 'Initials': 'DD', 'LastName': 'Ruff', 'Affiliation': 'Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.'}]",Headache,['10.1111/head.14013']
3068,33249552,Clinically Meaningful Changes on Depressive Symptom Measures and Patient-Reported Outcomes in Patients with Treatment-Resistant Depression.,"OBJECTIVE
To use the Clinical Global Impression-Severity (CGI-S) scale to estimate clinically meaningful and clinically substantial changes as measured using the Montgomery-Åsberg Depression Rating Scale (MADRS), the Sheehan Disability Scale (SDS), and the Patient Health Questionnaire-9 (PHQ-9) in patients with treatment-resistant depression (TRD).
METHODS
Pooled data were derived from two 4-week, randomized, active-controlled studies evaluating esketamine nasal spray (ESK) plus oral antidepressant (OAD) or OAD plus placebo nasal spray (PBO) in adults with TRD (N = 565). CGI-S, MADRS, SDS, and PHQ-9 scores were obtained at baseline and over 4 weeks of treatment. In this post hoc analysis, change scores on the MADRS, SDS, and PHQ-9 that corresponded to a clinically meaningful (1-point) or clinically substantial (2-point) change on the CGI-S scale were identified.
RESULTS
Clinically meaningful changes in CGI-S scores after 28 days corresponded to 6-, 4-, and 3-point changes from baseline on the MADRS, SDS, and PHQ-9, respectively. Similarly, a 2-point CGI-S score change (clinically substantial change) corresponded to a 12-, 8-, and 6-point change on the MADRS, SDS, and PHQ-9, respectively. The proportion of patients showing substantial clinical improvement in the ESK plus OAD group versus the OAD plus PBO group after 28 days of treatment favored ESK plus OAD: 69.0% vs 55.3% (MADRS), 64.5% vs 48.9% (SDS), and 77.1% vs 64.7% (PHQ-9).
CONCLUSION
We provide a basis for identifying clinically meaningful and clinically substantial changes as assessed with commonly used outcome measures for depression to facilitate the translation of clinical trial results into clinical practice.",2020,"The proportion of patients showing substantial clinical improvement in the ESK plus OAD group versus the OAD plus PBO group after 28 days of treatment favored ESK plus OAD: 69.0% vs 55.3% (MADRS), 64.5% vs 48.9% (SDS), and 77.1% vs 64.7% (PHQ-9).
","['Patients with Treatment-Resistant Depression', 'patients with treatment-resistant depression (TRD', 'adults with TRD (N = 565']",['esketamine nasal spray (ESK) plus oral antidepressant (OAD) or OAD plus placebo nasal spray (PBO'],"['MADRS, SDS, and PHQ-9', 'CGI-S, MADRS, SDS, and PHQ-9 scores', 'Depressive Symptom Measures', 'MADRS, SDS, and PHQ-9 that corresponded to a clinically meaningful (1-point) or clinically substantial (2-point) change on the CGI-S scale', 'CGI-S scores', 'Montgomery-Åsberg Depression Rating Scale (MADRS), the Sheehan Disability Scale (SDS), and the Patient Health Questionnaire-9 (PHQ-9', 'Clinical Global Impression-Severity (CGI-S) scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2825616', 'cui_str': 'esketamine'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}]",565.0,0.0553495,"The proportion of patients showing substantial clinical improvement in the ESK plus OAD group versus the OAD plus PBO group after 28 days of treatment favored ESK plus OAD: 69.0% vs 55.3% (MADRS), 64.5% vs 48.9% (SDS), and 77.1% vs 64.7% (PHQ-9).
","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Turkoz', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Alphs', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Jaskaran', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Janssen Research and Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Jamieson', 'Affiliation': 'Janssen Research and Development LLC, Milpitas, California, USA.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Shawi', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Sheehan', 'Affiliation': 'Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'UT Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13260']
3069,33249530,ABCB1 c.2677G>T/c.3435C>T diplotype increases the early-phase oral absorption of losartan.,"Losartan has been shown to be a substrate of the drug-efflux transporter MDR1, encoded by the ABCB1 gene. ABCB1 c.2677G>T and c.3435C>T variants are known to be associated with reduced expression and function of P-glycoprotein (P-gp). We investigated the effects of ABCB1 diplotype on the pharmacokinetics of losartan. Thirty-eight healthy Korean volunteers with different ABCB1 diplotypes [c.2677G> T and c.3435C>T; carriers of GG/CC (n = 13), GT/CT (n = 12) and TT/TT (n = 13) diplotype] were recruited and administered a single 50 mg oral dose of losartan potassium. Losartan and its active metabolite E-3174 samples in plasma and urine were collected up to 10 and 8 h after drug administration, respectively, and the concentrations of both samples were determined by HPLC method. Significant differences were observed in C max of losartan and losartan plus E-3174 (Lo + E) among the three diplotype groups (both P < 0.01). However, the power of the performed test is less than the desired power (0.800). The t max of losartan and E-3174 in three diplotype groups were also significantly different (both P < 0.01). The AUC values of Lo + E were significantly different among the three diplotype groups until 6 h after losartan administration (P < 0.01). On the contrary, AUC at the periods of 8-10 h and 10 h-infinity of Lo + E were significantly lower in the TT/TT group than in the GG/CC group. Urinary excretion of losartan until 4 h after losartan administration in the TT/TT group was higher than that of the GG/CC group. These results suggest that c.2677G>T/c.3435C>T diplotypes of ABCB1 may significantly increase the early-phase absorption of losartan, but not the total absorption.",2020,The AUC values of Lo + E were significantly different among the three diplotype groups until 6 h after losartan administration (P < 0.01).,['Thirty-eight healthy Korean volunteers with different ABCB1 diplotypes [c.2677G>\u2009T and c.3435C'],"['Losartan', 'losartan', 'ABCB1 diplotype', 'losartan potassium']","['C max of losartan and losartan plus E-3174 (Lo\u2009+\u2009E', 'T diplotype increases the early-phase oral absorption of losartan', 'AUC values of Lo\u2009+\u2009E', 'Urinary excretion of losartan']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C1738970', 'cui_str': 'ABCB1 protein, human'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0082525', 'cui_str': 'EXP3174'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.014115,The AUC values of Lo + E were significantly different among the three diplotype groups until 6 h after losartan administration (P < 0.01).,"[{'ForeName': 'Hyo-Bin', 'Initials': 'HB', 'LastName': 'Shin', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Eui Hyun', 'Initials': 'EH', 'LastName': 'Jung', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Pureum', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Chang Woo', 'Initials': 'CW', 'LastName': 'Lim', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Kyung-Yul', 'Initials': 'KY', 'LastName': 'Oh', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Chang-Keun', 'Initials': 'CK', 'LastName': 'Cho', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Yun Jeong', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'College of Pharmacy, Dankook University, Cheonan, 31116, Republic of Korea.'}, {'ForeName': 'Chang-Ik', 'Initials': 'CI', 'LastName': 'Choi', 'Affiliation': 'College of Pharmacy, Dongguk University-Seoul, Goyang, 10326, Republic of Korea.'}, {'ForeName': 'Choon-Gon', 'Initials': 'CG', 'LastName': 'Jang', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea.'}, {'ForeName': 'Seok-Yong', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'School of Pharmacy, Sungkyunkwan University, Suwon, 16419, Republic of Korea. sylee@skku.ac.kr.'}, {'ForeName': 'Jung-Woo', 'Initials': 'JW', 'LastName': 'Bae', 'Affiliation': 'College of Pharmacy, Keimyung University, Daegu, 42601, Republic of Korea.'}]",Archives of pharmacal research,['10.1007/s12272-020-01294-3']
3070,33249498,Switching to Progressively Reduced Nicotine Content Cigarettes in Smokers with Low Socioeconomic Status: A Double-Blind Randomized Clinical Trial.,"INTRODUCTION
The Food and Drug Administration issued an advanced notice of proposed rulemaking for setting a product standard for nicotine levels in cigarettes, with an emphasis on minimally or non-addicting very low nicotine content (VLNC).
METHODS
A 33-week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next 6 months. Participants were randomized to either Reduced Nicotine Content (RNC) study cigarettes tapered every 3 weeks to a final VLNC (0.2 mg/cigarette) for six weeks or to Usual Nicotine Content (UNC) study cigarettes (11.6 mg/cigarette). Outcomes included acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation.
RESULTS
The RNC (n= 122) vs. UNC (n=123) group had higher attrition (adjusted Hazard Ratio 3.4; 95% confidence interval [CI] 1.99-5.81). At the end of the intervention, cotinine levels were 50% lower in the RNC group (mean group difference -137 ng/mL; 95% CI -172, -102). The RNC group smoked fewer CPD (-4.1; 95% CI -6.44, -1.75) and had lower carbon monoxide levels (-4.0 ppm; 95% CI -7.7, -0.4). Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes (mean cotinine= 8.9 ng/ml). At three month follow-up, only compliant VLNC smokers quit with an assisted quit attempt (N=6/22, 27%).
CONCLUSIONS
This study supports a VLNC standard in cigarettes.
IMPLICATIONS
Differential dropout and noncompliance indicate some smokers had difficulty transitioning to cigarettes with reduced nicotine. These smokers will benefit from supplemental nicotine in medicinal or noncombustible tobacco products if a nicotine reduction standard is established. Other smokers in the study were able to successfully transition to VLNC cigarettes exclusively and substantially reduced their exposure to nicotine.",2020,The RNC group smoked fewer CPD,"['A 33-week, two-arm, double-blind randomized trial conducted in Hershey, Pennsylvania, USA and Washington, DC, USA included adult daily cigarette smokers (≥5 cigarettes per day) with less than a college degree, and who had no plans to quit within the next 6 months', 'Forty seven percent (29/62) of the RNC group were biochemically-confirmed compliant with smoking VLNC cigarettes ', 'n= 122) vs. UNC (n=123) group', 'Smokers with Low Socioeconomic Status']","['Reduced Nicotine Content (RNC) study cigarettes tapered every 3 weeks to a final VLNC (0.2\xa0mg/cigarette) for six weeks or to Usual Nicotine Content (UNC) study cigarettes', 'Nicotine Content Cigarettes', 'RNC', 'CPD']","['cotinine levels', 'acceptability of study cigarettes measured by attrition (primary outcome), compliance, reduction in cigarette dependence and tobacco biomarkers, and post-intervention cessation', 'lower carbon monoxide levels', 'higher attrition']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0566588', 'cui_str': 'Compliant'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}]","[{'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.187935,The RNC group smoked fewer CPD,"[{'ForeName': 'Nicolle M', 'Initials': 'NM', 'LastName': 'Krebs', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Junjia', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wasserman', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Kuprewicz', 'Affiliation': 'Georgetown University, Washington, D.C.'}, {'ForeName': 'Diane J', 'Initials': 'DJ', 'LastName': 'Martinez', 'Affiliation': 'IBM Watson Health, Washington, D.C.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Veldheer', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Livelsberger', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Modesto', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Biochemistry and Molecular Biology, Hershey, PA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Reinhart', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Trushin', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Reilly', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Fazzi', 'Affiliation': 'Penn State Health, Department of Pharmacy, Investigational Drug Service Pharmacy, Hershey, PA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Bascom', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Medicine, Hershey, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Richie', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Foulds', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Horn', 'Affiliation': 'Virginia Tech Carilion Research Institute, Department of Population Health Sciences, Roanoke, VA.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Muscat', 'Affiliation': 'Pennsylvania State University, Penn State College of Medicine, Department of Public Health Sciences, Hershey, PA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa247']
3071,33249492,Digital Cognitive Behavioral Therapy for Insomnia Promotes Later Health Resilience During the Coronavirus Disease 19 (COVID-19) Pandemic.,"STUDY OBJECTIVES
Stressful life events contribute to insomnia, psychosocial functioning, and illness. Though individuals with a history of insomnia may be especially vulnerable during stressful life events, risk may be mitigated by prior intervention. This study evaluated the effect of prior digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education on health resilience during the COVID-19 pandemic.
METHODS
COVID impact, insomnia, general- and COVID-related stress, depression, and global health were assessed in April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus sleep education control (n = 106) in 2016-2017. Regression analyses were used to evaluate the effect of intervention conditions on subsequent stress and health during the pandemic.
RESULTS
Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education. Moreover, the odds for resurgent insomnia was 51% lower in the dCBT-I versus control condition. Similarly, odds of moderate to severe depression during COVID-19 was 57% lower in the dCBT-I condition.
CONCLUSIONS
Those who received dCBT-I had increased health resilience during the COVID-19 pandemic in adults with a history of insomnia and ongoing mild to moderate mental health symptoms. These data provide evidence that dCBT-I is a powerful tool to promote mental and physical health during stressors, including the COVID-19 pandemic.",2020,"RESULTS
Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education.","['April 2020 in adults with a history of insomnia who completed a randomized controlled trial of dCBT-I (n = 102) versus', 'adults with a history of insomnia and ongoing mild to moderate mental health symptoms', 'n = 106) in 2016-2017']","['digital cognitive-behavioral therapy for insomnia (dCBT-I) versus sleep education', 'Digital Cognitive Behavioral Therapy', 'sleep education control', 'dCBT']","['resurgent insomnia', 'insomnia, general- and COVID-related stress, depression, and global health', 'insomnia symptoms', 'Later Health Resilience', 'general stress and COVID-related cognitive intrusions, less depression, and better global health', 'health resilience', 'severe depression', 'Insomnia symptoms']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}]",,0.0369317,"RESULTS
Insomnia symptoms were significantly associated with COVID-19 related disruptions, and those previously received dCBT-I reported less insomnia symptoms, less general stress and COVID-related cognitive intrusions, less depression, and better global health than those who received sleep education.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Melynda D', 'Initials': 'MD', 'LastName': 'Casement', 'Affiliation': 'Department of Psychology, University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Andrea Cuamatzi', 'Initials': 'AC', 'LastName': 'Castelan', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Sleep Disorders and Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep,['10.1093/sleep/zsaa258']
3072,33249482,Macro- and micro- vascular reactivity during repetitive exposure to shortened sleep: sex differences.,"Epidemiological studies have reported strong association between sleep loss and hypertension with unknown mechanisms. This study investigated macrovascular and microcirculation changes and inflammatory markers during repetitive sleep restriction. Sex differences were also explored. Forty-five participants completed a 22-day in-hospital protocol. Participants were assigned to: 1) Eight-hour sleep per night (control), or 2) Sleep restriction (SR) condition: participants slept from 0300-0700 hours for three nights followed by a recovery night of 8-h sleep, repeated four times. Flow mediated dilation (FMD) and microcirculation reactivity tests were performed at baseline, last day of each experimental block and during recovery at the end. Cell adhesion molecules and inflammatory marker levels were measured in blood samples. No duration of deprivation (SR block) by condition interaction effects were found for FMD, microcirculation, norepinephrine, cell adhesion molecules, IL-6 or IL-8. However, when men and women were analyzed separately, there was a statistical trend (p=0.08) for increased IL-6 across SR blocks in women, but not in men. Interestingly, men showed a significant progressive (dose dependent) increase in skin vasodilatation (p=0.02). A novel and unexpected finding was that during the recovery period, men that had been exposed to repeated SR blocks had elevated IL-8 and decreased norepinephrine. Macrocirculation, microcirculation, cell adhesion molecules and markers of inflammation appeared to be resistant to this model of short-term repetitive exposures to the blocks of shortened sleep in healthy sleepers. However, men and women responded differently, with women showing mild inflammatory response and men showing more vascular system sensitivity to the repetitive SR.",2020,"No duration of deprivation (SR block) by condition interaction effects were found for FMD, microcirculation, norepinephrine, cell adhesion molecules, IL-6 or IL-8.",['Forty-five participants completed a 22-day in-hospital protocol'],"['Eight-hour sleep per night (control), or 2) Sleep restriction (SR) condition: participants slept from 0300-0700 hours for three nights followed by a recovery night of 8-h sleep']","['vascular system sensitivity', 'skin vasodilatation', 'elevated IL-8 and decreased norepinephrine', 'Flow mediated dilation (FMD) and microcirculation reactivity tests', 'IL-6 across SR blocks', 'Macrocirculation, microcirculation, cell adhesion molecules and markers of inflammation', 'duration of deprivation (SR block', 'Cell adhesion molecules and inflammatory marker levels', 'FMD, microcirculation, norepinephrine, cell adhesion molecules, IL-6 or IL-8']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0235217', 'cui_str': 'Skin vasodilatation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}]",45.0,0.0501262,"No duration of deprivation (SR block) by condition interaction effects were found for FMD, microcirculation, norepinephrine, cell adhesion molecules, IL-6 or IL-8.","[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Baltzis', 'Affiliation': 'Department of Surgery, Beth Israel Deaconess Medical Center/Harvard Medical School.'}, {'ForeName': 'Vrushank', 'Initials': 'V', 'LastName': 'Bhatt', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Haack', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Meier-Ewert', 'Affiliation': 'Department of Medicine, Boston University School of Medicine.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Gautam', 'Affiliation': 'Department of Medicine, University of Florida College of Medicine - Jacksonville.'}, {'ForeName': 'Aristidis', 'Initials': 'A', 'LastName': 'Veves', 'Affiliation': 'Department of Surgery, Beth Israel Deaconess Medical Center/Harvard Medical School.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Mullington', 'Affiliation': 'Department of Neurology, Beth Israel Deaconess Medical Center/Harvard Medical School.'}]",Sleep,['10.1093/sleep/zsaa257']
3073,33249467,Periprocedural anticoagulation in the uninterrupted edoxaban vs. vitamin K antagonists for ablation of atrial fibrillation (ELIMINATE-AF) trial.,"AIMS
This post hoc analysis of ELIMINATE-AF evaluated requirements of unfractionated heparin (UFH) and procedure-related bleeding in atrial fibrillation (AF) patients undergoing ablation with uninterrupted edoxaban or vitamin K antagonist (VKA) therapy.
METHODS AND RESULTS
Patients were randomized 2:1 to once-daily edoxaban 60 mg (or dose-reduced 30 mg) or dose-adjusted VKA (target international normalized ratio: 2.0-3.0). Uninterrupted anticoagulation was mandated for 21-28 days' pre-ablation and 90 days' post-ablation. During ablation, UFH administration targeted an activated clotting time (ACT) of 300-400 s. Periprocedural bleeding was differentiated between procedure-related (bleeding at puncture side, cardiac tamponade) and unrelated events. Of 614 randomized patients, 553 received study drug and underwent catheter ablation (edoxaban n = 375; VKA n = 178). The median (Q1-Q3) time from last dose to ablation procedure was 14.8 (13.3-16.5) vs. 16.5 (14.8-19.5) h (edoxaban vs. VKA group, respectively). Mean ACT (SD) ≥300 s was observed in 52% edoxaban- vs. 76% VKA-treated patients, despite a higher mean (SD) UFH dose in the edoxaban vs. VKA group [14 261 (6397) IU vs. 11 473 (4300) IU; exploratory P-value < 0.0001]. In the edoxaban group, 13 patients (3.5%) had procedure-related bleeds of whom 9 had received an UFH dose above the median (13 000 IU). In the VKA arm, 7 patients (3.9%) had procedure-related bleeds of whom 3 had received an UFH dose above the median (10 225 IU).
CONCLUSION
The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.",2020,The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.,"['614 randomized patients, 553 received study drug and underwent', 'atrial fibrillation (AF) patients undergoing ablation with uninterrupted', 'Patients']","['unfractionated heparin (UFH', 'catheter ablation (edoxaban', 'edoxaban or vitamin K antagonist (VKA) therapy', 'edoxaban', 'edoxaban 60\u2009mg (or dose-reduced 30\u2009mg) or dose-adjusted VKA', 'edoxaban vs. VKA', 'edoxaban vs. vitamin K antagonists']","['Mean ACT (SD) ≥300\u2009s', 'rate of procedure-related major/clinically relevant non-major bleeding', 'activated clotting time (ACT', 'procedure-related bleeds', 'median (Q1-Q3) time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3872158', 'cui_str': 'edoxaban 60 MG [Savaysa]'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427611', 'cui_str': 'Coagulation time, activated'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0368930', 'cui_str': 'Coagulation time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",614.0,0.123206,The rate of procedure-related major/clinically relevant non-major bleeding did not differ between the treatment arms despite higher doses of UFH used with edoxaban vs. VKA to achieve a target ACT during AF ablation.,"[{'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Division of Clinical Electrophysiology, Department of Cardiology, Johann Wolfgang Goethe University, Theodor-Stern-Kai 7, 60596 Frankfurt am Main, Germany.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Camm', 'Affiliation': ""Department of Cardiology, Cardiology Clinical Academic Group, Molecular and Clinical Sciences Research Institute, St. George's University of London, Blackshaw Road, London SW17 0QT, UK.""}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Cappato', 'Affiliation': 'Department of Cardiovascular Diseases, Arrhythmia and Electrophysiology Research Center, Humanitas Clinical and Research Center, Via A. Manzoni 56, Rozzano, Milan 20089, Italy.'}, {'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'Medical Faculty, University Duisburg-Essen, Hufelandstr. 55, 45147 Essen, Germany.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Heidbüchel', 'Affiliation': 'Department of Cardiology, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Mont', 'Affiliation': 'Department of Cardiology, Cardiovascular CIBER, Hospital Clinic, University of Barcelona, Carrer de Villarroel 170, 08003 Barcelona, Spain.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Morillo', 'Affiliation': 'Division of Cardiology, Department of Cardiac Sciences, Libin Cardiovascular Institute, University of Calgary, 1403 29th Street NW, Calgary, Alberta T2N 2T9, Canada.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Rauer', 'Affiliation': 'Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Paul-Egbert', 'Initials': 'PE', 'LastName': 'Reimitz', 'Affiliation': 'Department of Biostatistics & Data Management, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Smolnik', 'Affiliation': 'Department of Global Medical Affairs, Daiichi Sankyo Europe GmbH, Zielstattstr. 48, 81379 München, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Kautzner', 'Affiliation': 'Department of Cardiology, Institute for Clinical and Experimental Medicine, Videnska 1958/9, 140 21 Prague, Czech Republic.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa199']
3074,33249458,A Pilot Randomized Clinical Trial of Remote Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation.,"INTRODUCTION
Medication sampling is a clinically useful tool to engage smokers in the quitting process. Whether varenicline is suitable for sampling purposes is unclear. The purpose of this study was to examine the feasibility, uptake, and preliminary outcomes of varenicline sampling.
METHODS
Smokers (N=99), both motivated to quit and not, were recruited and randomized to varenicline sampling vs. not, with 12 week follow-up. The intervention consisted of mailing one-time samples of varenicline (lasting 2-4wks), with minimally suggestive guidance on use.
RESULTS
Uptake of varenicline was strong, at 2 weeks (54% any use, 66% daily use) and 4 weeks (38%, 46%), with 58% of medication users seeking additional medication. Most users followed conventional titration patterns, self-titrating from 0.5mg to 2mg. Relative to control, varenicline sampling increased motivation (p=0.006) and confidence to quit (p=0.02), and decreased cigarette smoking (p=0.02). Smokers receiving varenicline samples were significantly more likely to achieve 50% reduction in CPD, both immediately following the sampling exercise (Adjusted Odds Ratio/AOR = 4.12; 95% CI: 1.39 - 12.17) and at final follow-up (AOR = 4.50; 95% CI: 1.56 - 13.01). Though cessation outcomes were not statistically significant, there was a 1.5 to 3-fold increase in quit attempts and abstinence from varenicline sampling throughout follow-up. These outcomes were comparable among smokers motivated to quit and not.
CONCLUSIONS
Unguided, user-driven sampling of varenicline sampling is a concrete behavioral exercise that is feasible to do and seems to suggest clinical utility. Sampling is a pragmatic clinical approach to engage more smokers in quitting.
IMPLICATIONS
Use of evidence-based pharmacotherapies for smoking cessation is low. Medication sampling is a pragmatic behavioral exercise that allows smokers to experience the benefits of using them, while promoting positive downstream effects towards quitting. While previous studies have shown that NRT sampling is viable and effective, whether this extends to varenicline is unclear. Results from this trial demonstrate that varenicline sampling is feasible, safe, and suggestive of clinically important steps toward quitting, deserving of a larger trial.",2020,"Relative to control, varenicline sampling increased motivation (p=0.006) and confidence to quit (p=0.02), and decreased cigarette smoking (p=0.02).","['Smokers (N=99), both motivated to quit and not']","['varenicline sampling', 'Remote Varenicline', 'varenicline (lasting 2-4wks), with minimally suggestive guidance on use', 'varenicline']","['motivation', 'cigarette smoking', 'quit attempts and abstinence', 'CPD']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0055816', 'cui_str': 'citrate phosphate dextrose'}]",,0.0395438,"Relative to control, varenicline sampling increased motivation (p=0.006) and confidence to quit (p=0.02), and decreased cigarette smoking (p=0.02).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC).'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC).'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Wahlquist', 'Affiliation': 'Department of Public Health Sciences, MUSC.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cropsey', 'Affiliation': 'Department of Psychiatry, University of Alabama, Birmingham.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Health Sciences and Research, MUSC.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Froeliger', 'Affiliation': 'Department of Psychiatry, University of Missouri.'}, {'ForeName': 'Tracy T', 'Initials': 'TT', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC).'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Toll', 'Affiliation': 'Department of Public Health Sciences, MUSC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina (MUSC).'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa241']
3075,33249320,Detraining effects after 18 months of high intensity resistance training on osteosarcopenia in older men Six-month follow-up of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST).,"PURPOSE
Detraining after dedicated exercise programs might be a frequent situation in older people's exercise patterns. The aim of the present study was thus to determine the effects of 6 months of detraining after 18 months of high intensity resistance exercise (HIT-RT) on musculoskeletal outcomes in older men with sarcopenia.
METHODS
Community-dwelling men aged 72 years and older with osteosarcopenia (n=43) were randomly assigned to an 18-month HIT-RT (EG: n=21) or a non-training control group (CG, n=22). After the intervention, participants of the EG stopped HIT-RT for 6 months, but continued their habitual physical activity. Study outcomes were skeletal muscle mass index, bone mineral density (BMD) at the lumbar-spine and total-hip, maximum hip/leg-extensor strength, handgrip strength and gait velocity. We applied an intention-to-treat analysis with multiple imputation.
RESULTS
Changes in the HIT-RT were much more pronounced during the detraining period compared with the CG, although this effect was only significant for skeletal muscle mass index and hip-/leg-extensor strength (p=.002 and p=.013), but not for lumbar-spine BMD (p=.068), total-hip BMD (p=.069), handgrip strength (p=.066) or gait velocity (p=.067). Apart from total-hip BMD (p=.055), handgrip strength (p=.069) and gait velocity (p=.881) values of the HIT-RT group decreased significantly during detraining. However, after 24 months, overall effects (p<.001) were still observed for skeletal muscle mass index and hip-/leg-extensor strength.
CONCLUSION
Although unable to state from which point in time relevant detraining effects emerge, we conclude that health care providers should focus on continuous rather than intermitted exercise programs for older people. Clinical trial number: clinicalTrials.gov: NCT03453463; NCT04444661.",2020,"However, after 24 months, overall effects (p<.001) were still observed for skeletal muscle mass index and hip-/leg-extensor strength.
","['older men with sarcopenia', 'Community-dwelling men aged 72 years and older with osteosarcopenia (n=43', 'older people', 'older men Six-month follow-up of the randomized controlled Franconian Osteopenia and Sarcopenia Trial (FrOST', ""older people's exercise patterns""]","['high intensity resistance training', 'high intensity resistance exercise (HIT-RT', 'HIT-RT (EG: n=21) or a non-training control']","['skeletal muscle mass index, bone mineral density (BMD) at the lumbar-spine and total-hip, maximum hip/leg-extensor strength, handgrip strength and gait velocity', 'gait velocity', 'total-hip BMD', 'handgrip strength', 'handgrip strength (p=.066) or gait velocity', 'skeletal muscle mass index and hip-/leg-extensor strength', 'lumbar-spine BMD', 'musculoskeletal outcomes']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0317314,"However, after 24 months, overall effects (p<.001) were still observed for skeletal muscle mass index and hip-/leg-extensor strength.
","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Kemmler', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, 91052 Erlangen, Germany. Electronic address: wolfgang.kemmler@imp.uni-erlangen.de.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kohl', 'Affiliation': 'Faculty Medical and Life Sciences, University of Furtwangen, 78054 Villingen-Schwenningen, Germany. Electronic address: Matthias.Kohl@hs-furtwangen.de.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fröhlich', 'Affiliation': 'Department of Sports Science, University of Kaiserslautern, 67663 Kaiserslautern, Germany. Electronic address: michael.froehlich@sowi.uni-kl.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schoene', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, 91052 Erlangen, Germany. Electronic address: daniel.schoene@fau.de.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'von Stengel', 'Affiliation': 'Institute of Medical Physics, Friedrich-Alexander University of Erlangen-Nürnberg, 91052 Erlangen, Germany. Electronic address: simon.von.stengel@imp.uni-erlangen.de.'}]",Bone,['10.1016/j.bone.2020.115772']
3076,33249268,Analgesic efficacy of intrauterine lidocaine flushing in hysterosalpingo-foam sonography: A double-blind randomized controlled trial.,"STUDY OBJECTIVE
To evaluate the efficacy of flushing the uterine cavity with lidocaine before Hysterosalpingo-Foam Sonography (HyFoSy) to reduce procedure-related pain.
DESIGN
A double-blind randomized controlled trial was conducted at the Department of Obstetrics & Gynecology, Shamir Medical Center, Israel between June 2020 and September 2020 involving 80 women undergoing HyFoSy procedure.
SETTING
University-affiliated medical center.
PATIENTS
Forty women were assigned randomly to the lidocaine group and 40 to the saline (placebo) group using a predetermined randomization code. Intrauterine instillation before the procedure consisting of either lidocaine 2% or normal saline alone was conducted, respectively.
INTERVENTIONS
The primary outcome measure was the visual analog scale (VAS) pain score during the phase of intrauterine foam instillation reported by the women following the procedure. The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10).
MEASUREMENTS AND MAIN RESULTS
The patient characteristics and obstetric data were found to be similar in both groups. Comparison of the VAS pain scores experienced during the procedure showed that women in the lidocaine flushing group rated the procedure less painful than the saline group (3.0±1.3 vs. 6.3±1.5, respectively; p=0.0001). The incidence of severe pain was significantly lower in the lidocaine group as compared to the saline group (2.5% and 45.0%, respectively, p=0.0001).
CONCLUSION
Lidocaine flushing of the uterine cavity before HyFoSy significantly decreased pain known to be caused by this procedure, and had the advantage of no side effects. It is easily applied, relatively inexpensive, and may affect compliance with this procedure.",2020,"The incidence of severe pain was significantly lower in the lidocaine group as compared to the saline group (2.5% and 45.0%, respectively, p=0.0001).
","['hysterosalpingo-foam sonography', 'Forty women', 'Department of Obstetrics & Gynecology, Shamir Medical Center, Israel between June 2020 and September 2020 involving 80 women undergoing HyFoSy procedure', 'University-affiliated medical center']","['intrauterine lidocaine flushing', 'lidocaine before Hysterosalpingo-Foam Sonography (HyFoSy', 'lidocaine', 'saline (placebo', 'Lidocaine']","['VAS scores, the pain level ratings', 'Analgesic efficacy', 'VAS pain scores', 'incidence of severe pain', 'visual analog scale (VAS) pain score', 'pain']","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",80.0,0.439911,"The incidence of severe pain was significantly lower in the lidocaine group as compared to the saline group (2.5% and 45.0%, respectively, p=0.0001).
","[{'ForeName': 'Yaakov', 'Initials': 'Y', 'LastName': 'Melcer', 'Affiliation': 'Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: ymeltcer@gmail.com.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Nimrodi', 'Affiliation': 'Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Levinsohn-Tavor', 'Affiliation': 'Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Gal', 'Initials': 'G', 'LastName': 'Kochav', 'Affiliation': 'Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pekar-Zlotin', 'Affiliation': 'Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Maymon', 'Affiliation': 'Department of Obstetrics and Gynecology, The Yitzhak Shamir Medical Center (formerly Assaf Harofeh Medical Center), affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.11.019']
3077,33249244,"Arthroscopic Bankart repair with and without curettage of the glenoid edge: A prospective, randomized, controlled study.","PURPOSE
To determine whether curettage of the cartilage on the glenoid edge in arthroscopic Bankart repair, reduces the postoperative recurrence rate as compared to the non-curetted glenoid.
METHODS
Between January 2010 and December 2013, 134 patients underwent arthroscopy and stabilization for recurrent anterior dislocation of shoulder. Total 42 patients were excluded. Alternate glenoid edge was curetted in ninety-two patients undergoing arthroscopic Bankart repair. Twelve patients were lost to follow-up. Thereby we had 80 patients which were divided in two groups, curettage & non-curettage, of 40 patients each. In both groups, the Bankart lesion was repaired using minimum 3 bioanchors loaded with non-absorbable braided sutures. Postoperative rehabilitation was the same for the 2 groups. We recorded recurrence of instability, pain, Constant and Rowe shoulder scores. Statistical analysis of data was performed using an unpaired t test (significance for P <0.05).
RESULTS
Both the groups were comparable in terms of age, number of dislocations and bone loss. The average follow-up was 7 years 9 months (range 6-10 years). Out of total 40 patients in the curettage group, 6(15%) patients had recurrence of dislocation and none had subluxations, whereas in the non-curettage group 13(32.5%) patients had recurrence of dislocation and 3(7.5%) had subluxations. The difference in postoperative recurrence of instability was statistically significant (p = 0.012). Average Rowe score in curettage group was 83.75(SD±23.28) and 70.13(SD±31.29) in non-curettage group, the p value being statistically significant(0.030).
CONCLUSIONS
During arthroscopic Bankart repair, curettage of the cartilage on anterior glenoid edge reduces the incidence of postoperative recurrence of instability.",2020,The difference in postoperative recurrence of instability was statistically significant (p = 0.012).,"['ninety-two patients undergoing arthroscopic Bankart repair', 'Total 42 patients were excluded', 'Between January 2010 and December 2013, 134 patients underwent arthroscopy and stabilization for recurrent anterior dislocation of shoulder', '80 patients which were divided in two groups, curettage & non-curettage, of 40 patients each']",['Arthroscopic Bankart repair with and without curettage of the glenoid edge'],"['recurrence of dislocation', 'postoperative recurrence of instability', 'recurrence of instability, pain, Constant and Rowe shoulder scores', 'postoperative recurrence rate', 'Postoperative rehabilitation']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0409411', 'cui_str': 'Recurrent anterior dislocation of shoulder'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}]","[{'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0010468', 'cui_str': 'Curettage'}, {'cui': 'C0205154', 'cui_str': 'Along edge'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0012691', 'cui_str': 'Dislocation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]",92.0,0.042146,The difference in postoperative recurrence of instability was statistically significant (p = 0.012).,"[{'ForeName': 'Sanjay S', 'Initials': 'SS', 'LastName': 'Desai', 'Affiliation': 'Consultant Orthopedic Surgeon, Bhatia Hospital, Mumbai.'}, {'ForeName': 'Vishwajeet', 'Initials': 'V', 'LastName': 'Singh', 'Affiliation': 'Shoulder and knee clinic: 11A Satguru, 16 French Bridge, Off Hughes Road, Mumbai-400007, Maharashtra, India.'}, {'ForeName': 'Hari Krishna', 'Initials': 'HK', 'LastName': 'Mata', 'Affiliation': 'Shoulder and knee clinic, 11A Satguru, 16 French Bridge, Off Hughes Road, Mumbai-400007, Maharashtra, India. Electronic address: krisorthodoc@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.11.042']
3078,33249003,Lumacaftor/ivacaftor in people with cystic fibrosis with an A455E-CFTR mutation.,"BACKGROUND
Previous in vitro organoid data showed A455E-CFTR, a rare CFTR mutation with 4.1% prevalence in the Netherlands, responds to lumacaftor/ivacaftor (LUM/IVA). We explored LUM/IVA's clinical efficacy in people with CF and ≥1 A455E-CFTR mutation.
METHODS
Participants aged ≥12 years were randomized to 1 of 2 treatment sequences (LUM/IVA→placebo or placebo→LUM/IVA) with an 8-week washout period between. Primary endpoint was absolute change in ppFEV 1 from study baseline through 8 weeks. Additional endpoints were change in sweat chloride concentration (SwCl) and CFQ-R respiratory domain score. Correlations between organoid-based measurements and clinical endpoints were investigated.
RESULTS
Twenty participants were randomized at 2 sites in the Netherlands. Mean absolute change in ppFEV 1 from study baseline through Week 8 showed a treatment difference of 0.1 percentage points (95% CI, -2.5 to 2.7; P = 0.928) between LUM/IVA (within-group mean change, 2.7) and placebo (within-group mean change, 2.6). The mean absolute change in SwCl concentration from study baseline through Week 8 showed a treatment difference of -7.8 mmol/L between LUM/IVA and placebo (P = 0.004), while the absolute change in CFQ-R respiratory domain score showed a treatment difference of 3.5 between LUM/IVA and placebo (P = 0.469). The in vitro organoid-based assay demonstrated a concentration-dependent swelling increase with LUM/IVA. Exploratory correlation analyses between organoid swelling and ppFEV 1 and SwCl outcomes showed correlation coefficients of 0.49 and -0.11, respectively.
CONCLUSIONS
In this exploratory study, LUM/IVA elicited an in vitro response in organoid swelling and in vivo response in SwCl in participants with CF and ≥1 A455E-CFTR mutation. The primary endpoint (ppFEV 1 ) did not show a statistically significant difference between LUM/IVA and placebo; correlations between in vitro and in vivo responses were not established (NCT03061331).",2020,The primary endpoint (ppFEV 1 ) did not show a statistically significant difference between LUM/IVA and placebo; correlations between in vitro and in vivo responses were not established (NCT03061331).,"['Twenty participants were randomized at 2 sites in the Netherlands', 'people with cystic fibrosis with an A455E-CFTR mutation', 'participants with CF and ≥1 A455E-CFTR mutation', 'people with CF and ≥1 A455E-CFTR mutation', 'Participants aged ≥12 years']","['Lumacaftor/ivacaftor', '2 treatment sequences (LUM/IVA→placebo or placebo→LUM/IVA', 'placebo']","['absolute change in ppFEV', 'sweat chloride concentration (SwCl) and CFQ-R respiratory domain score', 'CFQ-R respiratory domain score', 'mean absolute change in SwCl concentration']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C3852684', 'cui_str': 'lumacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0428295', 'cui_str': 'Cystic fibrosis sweat test'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",20.0,0.230756,The primary endpoint (ppFEV 1 ) did not show a statistically significant difference between LUM/IVA and placebo; correlations between in vitro and in vivo responses were not established (NCT03061331).,"[{'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Berkers', 'Affiliation': ""Department of Pediatric Pulmonology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands.""}, {'ForeName': 'Renske', 'Initials': 'R', 'LastName': 'van der Meer', 'Affiliation': 'HagaZiekenhuis, The Hague, the Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Heijerman', 'Affiliation': 'Department of Pulmonology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Beekman', 'Affiliation': ""Department of Pediatric Pulmonology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands; Regenerative Medicine Center Utrecht, University Medical Center Utrecht, Utrecht, the Netherlands.""}, {'ForeName': 'Sylvia F', 'Initials': 'SF', 'LastName': 'Boj', 'Affiliation': 'Foundation Hubrecht Organoid Technology, Utrecht, the Netherlands.'}, {'ForeName': 'Robert G J', 'Initials': 'RGJ', 'LastName': 'Vries', 'Affiliation': 'Foundation Hubrecht Organoid Technology, Utrecht, the Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Mourik', 'Affiliation': ""Department of Pediatric Pulmonology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands.""}, {'ForeName': 'Jamie R', 'Initials': 'JR', 'LastName': 'Doyle', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Audhya', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Zheng Jason', 'Initials': 'ZJ', 'LastName': 'Yuan', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Kinnman', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA.'}, {'ForeName': 'C Kors', 'Initials': 'CK', 'LastName': 'van der Ent', 'Affiliation': ""Department of Pediatric Pulmonology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, the Netherlands. Electronic address: k.vanderent@umcutrecht.nl.""}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.11.007']
3079,33248986,Effects of a Novel Nitroxyl Donor in Acute Heart Failure: The STAND-UP AHF Study.,"OBJECTIVES
The primary objective was to identify well-tolerated doses of cimlanod in patients with acute heart failure (AHF). Secondary objectives were to identify signals of efficacy, including biomarkers, symptoms, and clinical events.
BACKGROUND
Nitroxyl (HNO) donors have vasodilator, inotropic and lusitropic effects. Bristol-Myers Squibb-986231 (cimlanod) is an HNO donor being developed for acute heart failure (AHF).
METHODS
This was a phase IIb, double-blind, randomized, placebo-controlled trial of 48-h treatment with cimlanod compared with placebo in patients with left ventricular ejection fraction ≤40% hospitalized for AHF. In part I, patients were randomized in a 1:1 ratio to escalating doses of cimlanod or matching placebo. In part II, patients were randomized in a 1:1:1 ratio to either of the 2 highest tolerated doses of cimlanod from part I or placebo. The primary endpoint was the rate of clinically relevant hypotension (systolic blood pressure <90 mm Hg or patients became symptomatic).
RESULTS
In part I (n = 100), clinically relevant hypotension was more common with cimlanod than placebo (20% vs. 8%; relative risk [RR]: 2.45; 95% confidence interval [CI]: 0.83 to 14.53). In part II (n = 222), the incidence of clinically relevant hypotension was 18% for placebo, 21% for cimlanod 6 μg/kg/min (RR: 1.15; 95% CI: 0.58 to 2.43), and 35% for cimlanod 12 μg/kg/min (RR: 1.9; 95% CI: 1.04 to 3.59). N-terminal pro-B-type natriuretic peptide and bilirubin decreased during infusion of cimlanod treatment compared with placebo, but these differences did not persist after treatment discontinuation.
CONCLUSIONS
Cimlanod at a dose of 6 μg/kg/min was reasonably well-tolerated compared with placebo. Cimlanod reduced markers of congestion, but this did not persist beyond the treatment period. (Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure [STANDUP AHF]; NCT03016325).",2020,"N-terminal pro-B-type natriuretic peptide and bilirubin decreased during infusion of cimlanod treatment compared with placebo, but these differences did not persist after treatment discontinuation.
","['patients with acute heart failure (AHF', 'patients with left ventricular ejection fraction\xa0≤40% hospitalized for AHF', 'Hospitalized Patients', 'Failure', 'in Acute Heart']","['placebo', 'cimlanod', 'HNO', 'Bristol-Myers Squibb-986231 (cimlanod', 'cimlanod or matching placebo', 'Novel Nitroxyl Donor']","['rate of clinically relevant hypotension (systolic blood pressure\xa0<90\xa0mm', 'markers of congestion', 'N-terminal pro-B-type natriuretic peptide and bilirubin', 'signals of efficacy, including biomarkers, symptoms, and clinical events', 'incidence of clinically relevant hypotension', 'clinically relevant hypotension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0068882', 'cui_str': 'nitroxyl'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.774342,"N-terminal pro-B-type natriuretic peptide and bilirubin decreased during infusion of cimlanod treatment compared with placebo, but these differences did not persist after treatment discontinuation.
","[{'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke University School of Medicine and the Duke Clinical Research Institute, Durham, North Carolina, USA. Electronic address: michael.felker@duke.edu.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Cleland', 'Affiliation': 'Robertson Centre for Biostatistics, Institute of Health and Wellbeing, University of Glasgow, Glasgow Royal Infirmary, Glasgow, United Kingdom and National Heart & Lung Institute Imperial College, London, United Kingdom.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Teerlink', 'Affiliation': 'Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Adriaan A', 'Initials': 'AA', 'LastName': 'Voors', 'Affiliation': 'University of Groningen, Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Belohlavek', 'Affiliation': '2nd Department of Internal Medicine, Cardiovascular Medicine, General University Hospital, Charles University in Prague, Czech Republic.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Universitätsklinikum des Saarlandes, Saarland University, Homburg/Saar, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Borentain', 'Affiliation': 'Bristol-Myers-Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Bueno', 'Affiliation': 'Cardiology Department, Hospital Universitario 12 de Octubre and Instituto de Investigación Sanitaria Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Cole', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia, USA.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'DeSouza', 'Affiliation': 'Bristol-Myers-Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre at the University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Gerasimos', 'Initials': 'G', 'LastName': 'Filippatos', 'Affiliation': 'National and Kapodisrian University of Athens, School of Medicine, Athens, Greece.'}, {'ForeName': 'Ninian N', 'Initials': 'NN', 'LastName': 'Lang', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Kessler', 'Affiliation': 'Bristol-Myers-Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'Instituto DAMIC, Cordoba National University Cordoba, Argentina.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Mebazaa', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Saint Louis Lariboisière University Hospitals, Assistance Publique - Hôpitaux de Paris, Université de Paris, Inserm 942-MASCOT, FHU PROMICE, Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Metra', 'Affiliation': 'Institute of Cardiology, ASST Spedali Civili di Brescia and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Arend', 'Initials': 'A', 'LastName': 'Mosterd', 'Affiliation': 'Department of Cardiology, Meander Medical Center, Amersfoort, the Netherlands and Dutch Network for Cardiovascular Research, Utrecht, the Netherlands.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Pang', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, Indiana, USA.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Cardiology and Intensive Care Unit, Nippon Medical School, Musashi-Kosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Seiffert', 'Affiliation': 'Bristol-Myers-Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Bristol-Myers-Squibb, Princeton, New Jersey, USA.'}]",JACC. Heart failure,['10.1016/j.jchf.2020.10.012']
3080,33248978,Drug-Coated Balloon Versus Drug-Eluting Stent for Small Coronary Vessel Disease: PICCOLETO II Randomized Clinical Trial.,"OBJECTIVES
This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.
BACKGROUND
Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes.
METHODS
The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months.
RESULTS
Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm.
CONCLUSIONS
In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).",2020,"At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55).","['Small Coronary Vessel Disease Treatment', 'patients with de novo lesions', 'patients with de novo SVD lesions', 'Small Coronary Vessel Disease', 'Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers']","['DCB', 'DES', 'DCB or EES', 'novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California', 'Drug-Coated Balloon Versus Drug-Eluting Stent']","['Percent diameter stenosis and minimal lumen diameter', 'vessel thrombosis', 'minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events', 'adverse cardiac events', 'lesion LLL', 'spontaneous myocardial infarction', 'lesion late lumen loss (LLL']","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",232.0,0.123235,"At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55).","[{'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Cortese', 'Affiliation': 'Cardiovascular Research Team, San Carlo Clinic, Milano, Italy. Electronic address: bcortese@gmail.com.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Di Palma', 'Affiliation': 'Cardiovascular Research Team, San Carlo Clinic, Milano, Italy.'}, {'ForeName': 'Marcos Garcia', 'Initials': 'MG', 'LastName': 'Guimaraes', 'Affiliation': 'Cardiology Department, Hospital de la Princesa, Madrid, Spain.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Piraino', 'Affiliation': 'Interventional Cardiology, Giaccone Hospital, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Pedro Silva', 'Initials': 'PS', 'LastName': 'Orrego', 'Affiliation': 'Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Buccheri', 'Affiliation': 'Interventional Cardiology, San Giovanni di Dio Hospital, Trapani, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rivero', 'Affiliation': 'Cardiology Department, Hospital de la Princesa, Madrid, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Perotto', 'Affiliation': 'Interventional Cardiology, ASST Fatebenefratelli-Sacco, Milano, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Zambelli', 'Affiliation': 'Interventional Cardiology, Giaccone Hospital, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Cardiology Department, Hospital de la Princesa, Madrid, Spain.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2020.08.035']
3081,33248918,"Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Safety and Therapeutic Efficacy of Angiogenesis Induced by Intraarterial Autologous Bone Marrow-Derived Stem Cells in Patients with Severe Peripheral Arterial Disease.","PURPOSE
To evaluate safety and efficacy of angiogenesis induced by intraarterial autologous bone marrow-derived stem cell (BMSC) injection in patients with severe peripheral arterial disease (PAD).
MATERIALS AND METHODS
Eighty-one patients with severe PAD (77 men), including 56 with critical limb ischemia (CLI) and 25 with severe claudication, were randomized to receive sham injection (group A) or intraarterial BMSC injection at the site of occlusion (group B). Primary endpoints included improvement in ankle-brachial index (ABI) of > 0.1 and transcutaneous pressure of oxygen (TcPO 2 ) of > 15% at mid- and lower foot at 6 mo. Secondary endpoints included relief from rest pain, > 30% reduction in ulcer size, and reduction in major amputation in patients with CLI and > 50% improvement in pain-free walking distance in patients with severe claudication.
RESULTS
Technical success was achieved in all patients, without complications. At 6 mo, group B showed more improvements in ABI of > 0.1 (35 of 41 [85.37%] vs 13 of 40 [32.50%]; P < .0001) and TcPO 2 of > 15% at the midfoot (35 of 41 [85.37%] vs 17 of 40 [42.50%]; P = .0001] and lower foot (37 of 41 [90.24%] vs 19 of 40 [47.50%]; P < .0001). No patients with CLI underwent major amputation in group B, compared with 4 in group A (P = .0390). No significant difference was observed in relief from rest pain or > 30% reduction in ulcer size among patients with CLI or in > 50% improvement in pain-free walking distance among patients with severe claudication.
CONCLUSIONS
Intraarterial delivery of autologous BMSCs is safe and effective in the management of severe PAD.",2020,"No significant difference was observed in relief from rest pain or > 30% reduction in ulcer size among patients with CLI or in > 50% improvement in pain-free walking distance among patients with severe claudication.
","['patients with severe peripheral arterial disease (PAD', 'Patients with Severe Peripheral Arterial Disease', 'Eighty-one patients with severe PAD (77 men), including 56 with critical limb ischemia (CLI) and 25 with severe claudication']","['intraarterial BMSC injection', 'sham injection', 'autologous BMSCs', 'Intraarterial Autologous Bone Marrow-Derived Stem Cells', 'intraarterial autologous bone marrow-derived stem cell (BMSC) injection', 'Placebo']","['ankle-brachial index (ABI) of > 0.1 and transcutaneous pressure of oxygen (TcPO 2 ', 'relief from rest pain, > 30% reduction in ulcer size, and reduction in major amputation', 'ABI', 'ulcer size', 'Technical success', 'pain-free walking distance', 'relief from rest pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}]","[{'cui': 'C0694634', 'cui_str': 'Intra-arterial'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",81.0,0.384124,"No significant difference was observed in relief from rest pain or > 30% reduction in ulcer size among patients with CLI or in > 50% improvement in pain-free walking distance among patients with severe claudication.
","[{'ForeName': 'Sanjiv', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India. Electronic address: meetisv@yahoo.com.'}, {'ForeName': 'Niraj Nirmal', 'Initials': 'NN', 'LastName': 'Pandey', 'Affiliation': 'Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Mumun', 'Initials': 'M', 'LastName': 'Sinha', 'Affiliation': 'Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Jagia', 'Affiliation': 'Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Gurpreet Singh', 'Initials': 'GS', 'LastName': 'Gulati', 'Affiliation': 'Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Kalpnath', 'Initials': 'K', 'LastName': 'Gond', 'Affiliation': 'Department of Cardiovascular Radiology and Endovascular Interventions, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Stem Cell Facility, DBT-Centre of Excellence for Stem Cell Research, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}, {'ForeName': 'Balram', 'Initials': 'B', 'LastName': 'Bhargava', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.'}]",Journal of vascular and interventional radiology : JVIR,['10.1016/j.jvir.2020.09.003']
3082,33248904,"Effects of a six-week mobile app versus paper book intervention on quality of life, symptoms, and self-care in patients with fibromyalgia: a randomized parallel trial.","BACKGROUND
The ProFibro application (app) was developed as a Mobile Health resource to promote self-care in fibromyalgia management.
OBJECTIVE
This study aimed to assess the effects of the use of the ProFibro app for six weeks compared to the use of a traditional paper book of similar content to improve health-related quality of life, symptoms, and self-care agency in individuals with fibromyalgia.
METHODS
Forty individuals with fibromyalgia were included in this randomized, single-blind, parallel trial. One group received intervention content using the ProFibro app on a smartphone while the other received similar information using a paper book. Participants were assessed at baseline and after six weeks. The primary outcome was the Revised Fibromyalgia Impact Questionnaire. Secondary outcomes were Widespread Pain Index, Pain Visual Analog Scale, Symptom Severity Scale, and Appraisal of Self-Care Agency Scale - Revised.
RESULTS
No differences in changes were found between groups at the end of the treatment for any outcome. Both groups showed improvements in symptom severity.
CONCLUSIONS
The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia. Both groups showed improvements from baseline on severity of symptoms, suggesting that the self-care program using a mobile app or a paper book may be beneficial for individuals with fibromyalgia.",2020,"The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia.","['individuals with fibromyalgia', 'Forty individuals with fibromyalgia', 'patients with fibromyalgia']","['intervention content using the ProFibro app on a smartphone while the other received similar information using a paper book', 'six-week mobile app versus paper book intervention']","['symptom severity', 'Revised Fibromyalgia Impact Questionnaire', 'Widespread Pain Index, Pain Visual Analog Scale, Symptom Severity Scale, and Appraisal of Self-Care Agency Scale - Revised', 'quality of life, symptoms, and self-care', 'health-related quality of life, symptoms, and self-care agency']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205219', 'cui_str': 'Diffuse'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",40.0,0.129244,"The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia.","[{'ForeName': 'Susan Lee King', 'Initials': 'SLK', 'LastName': 'Yuan', 'Affiliation': 'Department of Physical Therapy, Speech Therapy and Occupational Therapy, School of Medicine, Universidade de Sao Paulo, São Paulo, SP, Brazil. Electronic address: susanlkyuan@yahoo.com.br.'}, {'ForeName': 'Letícia Assis', 'Initials': 'LA', 'LastName': 'Couto', 'Affiliation': 'Department of Physical Therapy, Speech Therapy and Occupational Therapy, School of Medicine, Universidade de Sao Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Amélia Pasqual', 'Initials': 'AP', 'LastName': 'Marques', 'Affiliation': 'Department of Physical Therapy, Speech Therapy and Occupational Therapy, School of Medicine, Universidade de Sao Paulo, São Paulo, SP, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.10.003']
3083,33248882,A pilot image interpretation teaching intervention to improve competence and confidence of radiographers to detect left ventricular thrombus in routine cardiac MRI scans.,"INTRODUCTION
Prompt diagnosis of left ventricular (LV) thrombus is clinically important, as it may require immediate anti-coagulation treatment. The aim of this study was to determine if a teaching intervention delivered by cardiovascular magnetic resonance (CMR) physicians would increase the CMR radiographers' ability to detect LV thrombus on a routine CMR scan.
METHODS
A cohort of 25 patients (14 with and 11 without LV thrombus) were identified. A multi-parametric CMR protocol had been performed in all patients. Ten radiographers reviewed the 25 randomised anonymised studies on a workstation, documenting the presence/absence of LV thrombus and their confidence level on a 7-point Likert scale. Two senior CMR fellows then delivered a focused teaching programme to the radiographers and all 25 randomised scans were reassessed 1 month after the teaching intervention.
RESULTS
Following dedicated training, there was a significant improvement in correct thrombus identification per radiographer (pre-training: 75 ± 6% vs post-training: 85 ± 6%, p = 0.009). The size of the thrombus was not associated with the likelihood of incorrectly identifying LV thrombus size prior to the training session (p = 0.2), but a trend was observed between smaller thrombus size and incorrect identifications post-training (p = 0.06). The radiographers' overall confidence in assessing the cases prior to the teaching session was high (5.6 ± 0.8 out of 7). Following the teaching session, self-reported confidence did not vary significantly (5.9 ± 0.7 out of 7, p = 0.42). When evaluating the teaching session, radiographers provided very positive feedback, rating the usefulness of the teaching intervention as highly educative (8.8 ± 0.4 out of 10).
CONCLUSIONS
This is the first study that has explored the ability and confidence of CMR radiographers in detecting LV thrombus on routine CMR scans as a result of the teaching intervention delivered by CMR physicians.
IMPLICATIONS FOR PRACTICE
A teaching intervention can improve CMR radiographers' diagnostic skills and diagnostic confidence.",2020,"Following dedicated training, there was a significant improvement in correct thrombus identification per radiographer (pre-training: 75 ± 6% vs post-training: 85 ± 6%, p = 0.009).",['25 patients (14 with and 11 without LV thrombus'],['teaching intervention delivered by cardiovascular magnetic resonance (CMR) physicians'],"['correct thrombus identification per radiographer', ""CMR radiographers' diagnostic skills and diagnostic confidence""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0876993', 'cui_str': 'Cardiac ventricular thrombosis'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0402007', 'cui_str': 'Medical radiographer'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}]",,0.0178001,"Following dedicated training, there was a significant improvement in correct thrombus identification per radiographer (pre-training: 75 ± 6% vs post-training: 85 ± 6%, p = 0.009).","[{'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lawton', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK. Electronic address: chris.lawton@uhbw.nhs.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Moharem-Elgamal', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK; National Heart Institute, Giza, Egypt.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Dastidar', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK; Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Luis Rodrigues', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK; Department of Radiology, Royal United Hospitals Bath NHS Foundation Trust, Bath, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Biglino', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK; Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bucciarelli-Ducci', 'Affiliation': 'Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK; Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK; Bristol National Institute of Health Research (NIHR) Biomedical Research Centre (BRC), UK.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2020.11.008']
3084,33248880,Effect of oral immunotherapy in children with milk allergy: The ORIMA study.,"BACKGROUND
This study was aimed at evaluating the efficacy and safety of oral immunotherapy (OIT) in children with severe cow's milk allergy.
METHODS
The subjects comprised 28 children (aged 3-12 years) with allergic symptoms that were induced by ≤ 10 mL of cow's milk in an oral food challenge test (OFC). The subjects were randomly allocated to the treatment group (n = 14) and control group (n = 14); the former received rush immunotherapy for 2 weeks, followed by a gradual increase of cow's milk volume to 100 mL for 1 year, and the latter completely eliminated cow's milk for 1 year. Both groups underwent an OFC with 100 mL of cow's milk after 1 year.
RESULTS
The treatment group had significantly higher rates of a negative OFC [7/14 (50%) vs. 0/14 (0%), p < 0.01] compared with the control group. The cow's milk-specific IgE level significantly decreased in the treatment group (p < 0.01) but not in the control group (p = 0.63). During the study period, adrenaline was required in 6/14 patients (43%) of the treatment group and in 0/14 patients (0%) of the control group. Long follow-up data were available at the 2-year point after the study for 8 in the treatment group and 7 (87.5%) of these continued to ingest milk (>100 mL).
CONCLUSIONS
The effect of immunotherapy was 50%, but the incidence of adverse events was not low. Further studies focusing on safety is necessary to standardize OIT for cow's milk allergy.",2020,The cow's milk-specific IgE level significantly decreased in the treatment group (p < 0.01) but not in the control group (p = 0.63).,"[""children with severe cow's milk allergy"", 'children with milk allergy', ""28 children (aged 3-12 years) with allergic symptoms that were induced by\xa0≤\xa010\xa0mL of cow's milk in an oral food challenge test (OFC""]","['immunotherapy', 'OFC', 'oral immunotherapy', 'rush immunotherapy', 'adrenaline', 'oral immunotherapy (OIT']","[""cow's milk-specific IgE level"", 'rates of a negative OFC', 'adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0079840', 'cui_str': 'Milk allergy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443052', 'cui_str': 'Rush'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C1997483', 'cui_str': 'Cow milk specific immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0272081,The cow's milk-specific IgE level significantly decreased in the treatment group (p < 0.01) but not in the control group (p = 0.63).,"[{'ForeName': 'Mayu', 'Initials': 'M', 'LastName': 'Maeda', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Takanori', 'Initials': 'T', 'LastName': 'Imai', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshinori', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kamiya', 'Affiliation': 'Department of Pediatrics, Showa University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Kimura', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Akashi', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hitomi', 'Initials': 'H', 'LastName': 'Tada', 'Affiliation': 'Division of Enzyme Chemistry, Institute for Enzyme Research, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Morita', 'Affiliation': 'Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Katsunuma', 'Affiliation': 'Department of Pediatrics, Daisan Hospital, The Jikei University School of Medicine, Tokyo, Japan. Electronic address: tkatsunuma@jikei.ac.jp.'}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.09.011']
3085,33248458,Increasing system-wide implementation of opioid prescribing guidelines in primary care: findings from a non-randomized stepped-wedge quality improvement project.,"BACKGROUND
Clinician utilization of practice guidelines can reduce inappropriate opioid prescribing and harm in chronic non-cancer pain; yet, implementation of ""opioid guidelines"" is subpar. We hypothesized that a multi-component quality improvement (QI) augmentation of ""routine"" system-level implementation efforts would increase clinician adherence to the opioid guideline-driven policy recommendations.
METHODS
Opioid policy was implemented system-wide in 26 primary care clinics. A convenience sample of 9 clinics received the QI augmentation (one-hour academic detailing; 2 online educational modules; 4-6 monthly one-hour practice facilitation sessions) in this non-randomized stepped-wedge QI project. The QI participants were volunteer clinic staff. The target patient population was adults with chronic non-cancer pain treated with long-term opioids. The outcomes included the clinic-level percentage of target patients with a current treatment agreement (primary outcome), rates of opioid-benzodiazepine co-prescribing, urine drug testing, depression and opioid misuse risk screening, and prescription drug monitoring database check; additional measures included daily morphine-equivalent dose (MED), and the percentages of all target patients and patients prescribed ≥90 mg/day MED. T-test, mixed-regression and stepped-wedge-based analyses evaluated the QI impact, with significance and effect size assessed with two-tailed p < 0.05, 95% confidence intervals and/or Cohen's d.
RESULTS
Two-hundred-fifteen QI participants, a subset of clinical staff, received at least one QI component; 1255 patients in the QI and 1632 patients in the 17 comparison clinics were prescribed long-term opioids. At baseline, more QI than comparison clinic patients were screened for depression (8.1% vs 1.1%, p = 0.019) and prescribed ≥90 mg/day MED (23.0% vs 15.5%, p = 0.038). The stepped-wedge analysis did not show statistically significant changes in outcomes in the QI clinics, when accounting for the comparison clinics' trends. The Cohen's d values favored the QI clinics in all outcomes except opioid-benzodiazepine co-prescribing. Subgroup analysis showed that patients prescribed ≥90 mg/day MED in the QI compared to comparison clinics improved urine drug screening rates (38.8% vs 19.1%, p = 0.02), but not other outcomes (p ≥ 0.05).
CONCLUSIONS
Augmenting routine policy implementation with targeted QI intervention, delivered to volunteer clinic staff, did not additionally improve clinic-level, opioid guideline-concordant care metrics. However, the observed effect sizes suggested this approach may be effective, especially in higher-risk patients, if broadly implemented.
TRIAL REGISTRATION
Not applicable.",2020,"Subgroup analysis showed that patients prescribed ≥90 mg/day MED in the QI compared to comparison clinics improved urine drug screening rates (38.8% vs 19.1%, p = 0.02), but not other outcomes (p ≥ 0.05).
","['primary care', '26 primary care clinics', 'patient population was adults with chronic non-cancer pain treated with long-term opioids']",['QI augmentation (one-hour academic detailing; 2 online educational modules; 4-6 monthly one-hour practice facilitation sessions'],"['depression', 'urine drug screening rates', 'clinic-level percentage of target patients with a current treatment agreement (primary outcome), rates of opioid-benzodiazepine co-prescribing, urine drug testing, depression and opioid misuse risk\xa0screening, and prescription drug monitoring database check; additional measures included daily morphine-equivalent dose (MED']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0202274', 'cui_str': 'Urine drug screening'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",215.0,0.109838,"Subgroup analysis showed that patients prescribed ≥90 mg/day MED in the QI compared to comparison clinics improved urine drug screening rates (38.8% vs 19.1%, p = 0.02), but not other outcomes (p ≥ 0.05).
","[{'ForeName': 'Aleksandra E', 'Initials': 'AE', 'LastName': 'Zgierska', 'Affiliation': 'Departments of Family and Community Medicine, Public Health Sciences, and Anesthesiology and Perioperative Medicine, Penn State College of Medicine, 500 University Drive, PA, 17033, Hershey, USA. azgierska@pennstatehealth.psu.edu.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Center for Health Systems Research and Analysis, University of Wisconsin-Madison, 1109C WARF Building, 610 Walnut Street, Madison, WI, 53726, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Lennon', 'Affiliation': 'Department of Family and Community Medicine, Penn State College of Medicine, 500 University Drive, Hershey, PA, 17033, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Smith', 'Affiliation': 'Department of Family Medicine and Community Health, Wisconsin Research and Education Network (WREN), University of Wisconsin-Madison, School of Medicine and Public Health, 1100 Delaplaine Court, Madison, WI, 53715, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Nisbet', 'Affiliation': 'Interstate Postgraduate Medical Association, P.O. Box 5474, Madison, WI, 53705, USA.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Ales', 'Affiliation': 'Interstate Postgraduate Medical Association, P.O. Box 5474, Madison, WI, 53705, USA.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Boss', 'Affiliation': 'Department of Family Medicine and Community Health, Wisconsin Research and Education Network (WREN), University of Wisconsin-Madison, School of Medicine and Public Health, 1100 Delaplaine Court, Madison, WI, 53715, USA.'}, {'ForeName': 'Wen-Jan', 'Initials': 'WJ', 'LastName': 'Tuan', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, School of Medicine and Public Health, 1100 Delaplaine Court, Madison, WI, 53715, USA.'}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Vidaver', 'Affiliation': 'Department of Family Medicine and Community Health, Wisconsin Research and Education Network (WREN), University of Wisconsin-Madison, School of Medicine and Public Health, 1100 Delaplaine Court, Madison, WI, 53715, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Hahn', 'Affiliation': 'Department of Family Medicine and Community Health, Wisconsin Research and Education Network (WREN), University of Wisconsin-Madison, School of Medicine and Public Health, 1100 Delaplaine Court, Madison, WI, 53715, USA.'}]",BMC family practice,['10.1186/s12875-020-01320-9']
3086,33248457,Prevention of sickness absence through early identification and rehabilitation of at-risk patients with musculoskeletal pain (PREVSAM): a randomised controlled trial protocol.,"BACKGROUND
Musculoskeletal pain is globally a leading cause of physical disability. Many musculoskeletal-related pain conditions, such as low back pain, often resolve spontaneously. In some individuals, pain may recur or persist, leading to ong-term physical disability, reduced work capacity, and sickness absence. Early identification of individuals in which this may occur, is essential for preventing or reducing the risk of developing persistent musculoskeletal pain and long-term sickness absence. The aim of the trial described in this protocol is to evaluate effects of an early intervention, the PREVSAM model, on the prevention of sickness absence and development of persistent pain in at-risk patients with musculoskeletal pain.
METHODS
Eligible participants are adults who seek health care for musculoskeletal pain and who are at risk of developing persistent pain, physical disability, and sickness absence. Participants may be recruited from primary care rehabilitation centres or primary care healthcare centres in Region Västra Götaland. Participants will be randomised to treatment according to the PREVSAM model (intervention group) or treatment as usual (control group). The PREVSAM model comprises an interdisciplinary, person-centred rehabilitation programme, including coordinated measures within primary health care, and may include collaboration with participants' employers. The primary outcome sickness absence is operationalised as the number and proportion of individuals who remain in full- or part-time work, the number of gross and net days of sickness absence during the intervention and follow-up period, and time to first sickness absence spell. Secondary outcomes are patient-reported short-term sickness absence, work ability, pain, self-efficacy, health-related quality of life, risk for sickness absence, anxiety and depression symptoms and physical disability at 1 and 3 months after inclusion (short-term follow-up), and at 6 and 12 months (long-term follow-up). A cost-effectiveness analysis is planned and drug consumption will be investigated.
DISCUSSION
The study is expected to provide new knowledge on the effectiveness of a comprehensive rehabilitation model that incorporates early identification of patients with musculoskeletal pain at risk for development of sickness absence and persistent pain. The study findings may contribute to more effective rehabilitation processes of this large patient population, and potentially reduce sickness absence and costs.
TRIAL REGISTRATION
ClinicalTrials.gov Protocol ID: NCT03913325 , Registered April 12, 2019. Version 2, 10 July 2020. Version 2 changes: Clarifications regarding trial aim and inclusion process.",2020,"Early identification of individuals in which this may occur, is essential for preventing or reducing the risk of developing persistent musculoskeletal pain and long-term sickness absence.","['Eligible participants are adults who seek health care for musculoskeletal pain and who are at risk of developing persistent pain, physical disability, and sickness absence', 'patients with musculoskeletal pain at risk for development of sickness absence and persistent pain', 'at-risk patients with musculoskeletal pain (PREVSAM', 'at-risk patients with musculoskeletal pain', 'Participants may be recruited from primary care rehabilitation centres or primary care healthcare centres in Region Västra Götaland']",['PREVSAM model (intervention group) or treatment as usual (control group'],"['sickness absence is operationalised as the number and proportion of individuals who remain in full- or part-time work, the number of gross and net days of sickness absence during the intervention and follow-up period, and time to first sickness absence spell', 'patient-reported short-term sickness absence, work ability, pain, self-efficacy, health-related quality of life, risk for sickness absence, anxiety and depression symptoms and physical disability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0682294', 'cui_str': 'Part-time employment'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}]",,0.129567,"Early identification of individuals in which this may occur, is essential for preventing or reducing the risk of developing persistent musculoskeletal pain and long-term sickness absence.","[{'ForeName': 'Meh', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': 'Department of Education, Research and Development Primary Health Care, Region Västra Götaland, Gothenburg, Sweden. maria.eh.larsson@vgregion.se.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nordeman', 'Affiliation': 'Unit of Physiotherapy, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Holmgren', 'Affiliation': 'Unit of Occupational Therapy, Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grimby-Ekman', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hensing', 'Affiliation': 'School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Björkelund', 'Affiliation': 'Primary Care, School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bergman', 'Affiliation': 'Primary Care, School of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ekhammar', 'Affiliation': 'Department of Education, Research and Development Primary Health Care, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dottori', 'Affiliation': 'Department of Education, Research and Development Primary Health Care, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bernhardsson', 'Affiliation': 'Department of Education, Research and Development Primary Health Care, Region Västra Götaland, Gothenburg, Sweden.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03790-5']
3087,33252870,A Randomized Trial of Laryngeal Mask Airway in Neonatal Resuscitation.,"BACKGROUND
Face-mask ventilation is the most common resuscitation method for birth asphyxia. Ventilation with a cuffless laryngeal mask airway (LMA) has potential advantages over face-mask ventilation during neonatal resuscitation in low-income countries, but whether the use of an LMA reduces mortality and morbidity among neonates with asphyxia is unknown.
METHODS
In this phase 3, open-label, superiority trial in Uganda, we randomly assigned neonates who required positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation. All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both. The primary outcome was a composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization.
RESULTS
Complete follow-up data were available for 99.2% of the neonates. A primary outcome event occurred in 154 of 563 neonates (27.4%) in the LMA group and 144 of 591 (24.4%) in the face-mask group (adjusted relative risk, 1.16; 95% confidence interval [CI], 0.90 to 1.51; P = 0.26). Death within 7 days occurred in 21.7% of the neonates in the LMA group and 18.4% of those in the face-mask group (adjusted relative risk, 1.21; 95% CI, 0.90 to 1.63), and admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization occurred in 11.2% and 10.1%, respectively (adjusted relative risk, 1.27; 95% CI, 0.84 to 1.93). Findings were materially unchanged in a sensitivity analysis in which neonates with missing data were counted as having had a primary outcome event in the LMA group and as not having had such an event in the face-mask group. The frequency of predefined intervention-related adverse events was similar in the two groups.
CONCLUSIONS
In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy. (Funded by the Research Council of Norway and the Center for Intervention Science in Maternal and Child Health; NeoSupra ClinicalTrials.gov number, NCT03133572.).",2020,"In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy.","['neonates with asphyxia', 'Neonatal Resuscitation', 'All the neonates had an estimated gestational age of at least 34 weeks, an estimated birth weight of at least 2000 g, or both']","['Ventilation with a cuffless laryngeal mask airway (LMA', 'LMA', 'positive-pressure ventilation to be treated by a midwife with an LMA or with face-mask ventilation']","['frequency of predefined intervention-related adverse events', 'admission to the NICU with moderate-to-severe hypoxic-ischemic encephalopathy', 'composite of death within 7 days or admission to the neonatal intensive care unit (NICU) with moderate-to-severe hypoxic-ischemic encephalopathy at day 1 to 5 during hospitalization', 'Death']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004044', 'cui_str': 'Asphyxiation'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0470277', 'cui_str': '2000'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0024861', 'cui_str': 'Mask'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.224248,"In neonates with asphyxia, the LMA was safe in the hands of midwives but was not superior to face-mask ventilation with respect to early neonatal death and moderate-to-severe hypoxic-ischemic encephalopathy.","[{'ForeName': 'Nicolas J', 'Initials': 'NJ', 'LastName': 'Pejovic', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Myrnerts Höök', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Alfvén', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Lubulwa', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Jolly', 'Initials': 'J', 'LastName': 'Nankunda', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Hege', 'Initials': 'H', 'LastName': 'Ersdal', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Blennow', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Trevisanuto', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': ""From the Center for International Health (N.J.P., S.M.H., T.T.) and the Center for Intervention Science in Maternal and Child Health (T.T.), University of Bergen, Bergen, and the Department of Anesthesiology and Intensive Care, Stavanger University Hospital (H.E.), and the Faculty of Health Sciences, University of Stavanger (H.E.), Stavanger - both in Norway; Sachs' Children and Youth Hospital (N.J.P., S.M.H., T.A.) and the Departments of Global Public Health (N.J.P., S.M.H., T.A.) and Clinical Science, Technology, and Intervention (M.B.), Karolinska Institutet, and the Department of Neonatal Medicine, Karolinska University Hospital (M.B.) - all in Stockholm; Mulago National Referral Hospital (J.B., C.L., J.N.) and the Departments of Obstetrics and Gynecology (J.B.) and Pediatrics and Child Health (J.N.), College of Health Sciences, Makerere University, Kampala, Uganda; and independent statistician, Solagna (F.C.), and the Department of Women's and Children's Health, Padua University, Padua (D.T.) - both in Italy.""}]",The New England journal of medicine,['10.1056/NEJMoa2005333']
3088,33248858,Adaptive ankle exoskeleton gait training demonstrates acute neuromuscular and spatiotemporal benefits for individuals with cerebral palsy: A pilot study.,"BACKGROUND
Gait abnormalities from neuromuscular conditions like cerebral palsy (CP) limit mobility and negatively affect quality of life. Increasing walking speed and stride length are essential clinical goals in the treatment of gait disorders from CP.
RESEARCH QUESTION
How does over-ground gait training with an untethered ankle exoskeleton providing adaptive assistance affect mobility-related spatiotemporal outcomes and lower-extremity muscle activity in people with CP?
METHODS
A diverse cohort of individuals with CP (n = 6, age 9-31, Gross Motor Function Classification System Level I - III) completed four over-ground training sessions (98 ± 17 min of assisted walking) and received pre- and post-training assessments. On both assessments, participants walked over-ground with and without the exoskeleton while we recorded spatiotemporal outcomes and muscle activity. We used two-tailed paired t-tests to compare all parameters pre- and post-training, and between assisted and unassisted conditions.
RESULTS
Following training, walking speed increased 0.24 m/s (p = 0.006) and stride length increased 0.17 m (p = 0.013) during unassisted walking, while walking speed increased 0.28 m/s (p = 0.023) and stride length increased 0.15 m (p = 0.002) during exoskeleton-assisted walking. Exoskeleton training improved stride-to-stride repeatability of soleus and vastus lateralis muscle activation by up to 51 % (p ≤ 0.046), while the amount of integrated stance-phase muscle activity was similar across visits and conditions. Relative to baseline, post-training walking with the exoskeleton resulted in a soleus activity pattern that was 39 % more similar to the typical pattern from unimpaired individuals (p < 0.001).
SIGNIFICANCE
This study demonstrates acute spatiotemporal and neuromuscular benefits from over-ground training with adaptive ankle exoskeleton assistance, and provides rationale for completion of a longer randomized controlled training protocol.",2020,"Exoskeleton training improved stride-to-stride repeatability of soleus and vastus lateralis muscle activation by up to 51 % (p ≤ 0.046), while the amount of integrated stance-phase muscle activity was similar across visits and conditions.","['people with CP', 'A diverse cohort of individuals with CP (n\u202f=\u202f6, age 9-31, Gross Motor Function Classification System Level I - III) completed four over', 'individuals with cerebral palsy']","['Exoskeleton training', 'ground training sessions (98\u202f±\u202f17\u202fmin of assisted walking) and received pre- and post-training assessments', 'Adaptive ankle exoskeleton gait training']","['Increasing walking speed and stride length', 'integrated stance-phase muscle activity', 'soleus activity pattern', 'stride length', 'stride-to-stride repeatability of soleus and vastus lateralis muscle activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.031272,"Exoskeleton training improved stride-to-stride repeatability of soleus and vastus lateralis muscle activation by up to 51 % (p ≤ 0.046), while the amount of integrated stance-phase muscle activity was similar across visits and conditions.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Mechanical Engineering, Northern Arizona University, Flagstaff, AZ 86011, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Orekhov', 'Affiliation': 'Department of Mechanical Engineering, Northern Arizona University, Flagstaff, AZ 86011, USA.'}, {'ForeName': 'Zachary F', 'Initials': 'ZF', 'LastName': 'Lerner', 'Affiliation': 'Department of Mechanical Engineering, Northern Arizona University, Flagstaff, AZ 86011, USA; Department of Orthopedics, the University of Arizona College of Medicine-Phoenix, Phoenix, AZ 85004, USA. Electronic address: Zachary.Lerner@nau.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.11.005']
3089,33248796,Prevention of posttraumatic stress disorder in mothers of preterm infants using trauma-focused group therapy: Manual development and evaluation.,"BACKGROUND
Preterm birth has been associated with a number of adverse maternal psychological outcomes.
AIMS
The current study aims to develop and evaluate the feasibility of a trauma-focused group intervention that is designed to reduce maternal symptoms of anxiety, depression, and posttraumatic stress in a sample of mothers of preterm infants hospitalized in a neonatal intensive care unit (NICU).
STUDY DESIGN
The study was a one-group pre-/post quasi-experimental design. Participants received a 6-session intervention targeting parental trauma.
SUBJECTS
English-speaking mothers (N = 19) greater than 18 years of age of infants 23-34 weeks gestational age hospitalized in the NICU at Lucile Packard Children's Hospital Stanford.
OUTCOME MEASURES
Beck Anxiety Inventory (BAI), Beck Depression Inventory, Second Edition (BDI-II), Davidson Trauma Scale (DTS).
RESULTS
Results from the study indicate that the intervention is feasible, able to be implemented with a high degree of fidelity, is rated as highly satisfactory by participants, and leads to statistically significant reductions in symptoms of anxiety, depression, and posttraumatic stress at 6-week and 6-month follow-ups.
CONCLUSIONS
Though encouraging, these findings are preliminary, and future studies should strive to reproduce these findings with a larger sample size and a comparison group.",2020,"RESULTS
Results from the study indicate that the intervention is feasible, able to be implemented with a high degree of fidelity, is rated as highly satisfactory by participants, and leads to statistically significant reductions in symptoms of anxiety, depression, and posttraumatic stress at 6-week and 6-month follow-ups.
","['mothers of preterm infants', 'mothers of preterm infants hospitalized in a neonatal intensive care unit (NICU', ""English-speaking mothers (N\xa0=\xa019) greater than 18\xa0years of age of infants 23-34\xa0weeks gestational age hospitalized in the NICU at Lucile Packard Children's Hospital Stanford""]",['6-session intervention targeting parental trauma'],"['maternal symptoms of anxiety, depression, and posttraumatic stress', 'symptoms of anxiety, depression, and posttraumatic stress', 'Beck Anxiety Inventory (BAI), Beck Depression Inventory, Second Edition (BDI-II), Davidson Trauma Scale (DTS']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0793704,"RESULTS
Results from the study indicate that the intervention is feasible, able to be implemented with a high degree of fidelity, is rated as highly satisfactory by participants, and leads to statistically significant reductions in symptoms of anxiety, depression, and posttraumatic stress at 6-week and 6-month follow-ups.
","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Simon', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, 1791 Arastradero Road, Palo Alto, CA 94304, USA.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Moreyra', 'Affiliation': ""Children's Hospital Los Angeles, 4650 Sunset Boulevard, Los Angeles, CA 90027, USA. Electronic address: amoreyra@chla.usc.edu.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Wharton', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, 1791 Arastradero Road, Palo Alto, CA 94304, USA. Electronic address: ewharton@stanford.edu.'}, {'ForeName': 'LaTrice L', 'Initials': 'LL', 'LastName': 'Dowtin', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Stanford University School of Medicine, 401 Quarry Road, Palo Alto, CA 94305, USA. Electronic address: ldowtin@playfulleighpsyched.com.'}, {'ForeName': 'Tonyanna C', 'Initials': 'TC', 'LastName': 'Borkovi', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Stanford University School of Medicine, 401 Quarry Road, Palo Alto, CA 94305, USA. Electronic address: tonyanna@stanfordalumni.org.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Armer', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Stanford University School of Medicine, 401 Quarry Road, Palo Alto, CA 94305, USA. Electronic address: earmer@stanford.edu.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Shaw', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Stanford University School of Medicine, 401 Quarry Road, Palo Alto, CA 94305, USA. Electronic address: rjshaw@stanford.edu.'}]",Early human development,['10.1016/j.earlhumdev.2020.105282']
3090,33248750,Effect of Dry Needling on Spinal Reflex Excitability and Postural Control in Individuals With Chronic Ankle Instability.,"OBJECTIVE
The purpose of this study was to compare postural control and neurophysiologic components of balance after dry needling of the fibularis longus between individuals with chronic ankle instability (CAI) and a healthy control group.
METHODS
This quasi-experimental university-laboratory study included 50 adult volunteers-25 with CAI (16 female, 9 male; age: 26 ± 9.42 years; height: 173.12 ± 9.85 cm; weight: 79.27 ± 18 kg) and 25 healthy controls (15 female, 10 male; age: 25.8 ± 5.45 years; height: 169.47 ± 9.43 cm; weight: 68.47 ± 13 kg). Participants completed the Star Excursion Balance Test (SEBT), single-leg balance, and assessment of spinal reflex excitability before and after a single treatment of dry needling to the fibularis longus. The anterior, posterolateral, and posteromedial directions of the SEBT were randomized, and reach distances were normalized to a percentage of leg length. A composite SEBT score was calculated by averaging the normalized scores. Postural control was assessed in single-limb stance on a force plate through time-to-boundary measurements in eyes-open and eyes-closed conditions. Fibularis longus and soleus spinal reflexes were obtained by providing electrical stimulation to the common fibular and tibial nerves with participants lying prone. A Group × Time analysis examined changes in performance, and effect sizes were calculated to assess significance.
RESULTS
Significant group × time interactions were identified for composite (P = .006) and posteromedial (P = .017) SEBT scores. Significant time effects for all directions of the SEBT, time to boundary with eyes open, and the mediolateral direction with eyes closed indicate improved postural control following treatment (P < .008). Within-group effect sizes for significant time effects ranged from small to large, indicating potential clinical utility.
CONCLUSION
Dry needling demonstrated immediate short-term improvement in measures of static and postural control in individuals with CAI as well as healthy controls.",2020,Dry needling demonstrated immediate short-term improvement in measures of static and postural control in individuals with CAI as well as healthy controls.,"['individuals with chronic ankle instability (CAI) and a healthy control group', 'Individuals With Chronic Ankle Instability', '50 adult volunteers-25 with CAI (16 female, 9 male; age: 26 ± 9.42 years; height: 173.12 ± 9.85 cm; weight: 79.27 ± 18 kg) and 25 healthy controls (15 female, 10 male; age: 25.8 ± 5.45 years; height: 169.47 ± 9.43 cm; weight: 68.47 ± 13 kg', 'individuals with CAI as well as healthy controls']","['Dry Needling', 'Dry needling']","['performance, and effect sizes', 'Fibularis longus and soleus spinal reflexes', 'composite SEBT score', 'Spinal Reflex Excitability and Postural Control', 'time interactions', 'Star Excursion Balance Test (SEBT), single-leg balance, and assessment of spinal reflex excitability', 'SEBT scores', 'static and postural control', 'postural control']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0224469', 'cui_str': 'Peroneus longus muscle structure'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441463', 'cui_str': 'Static'}]",50.0,0.0276934,Dry needling demonstrated immediate short-term improvement in measures of static and postural control in individuals with CAI as well as healthy controls.,"[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Mullins', 'Affiliation': 'Department of Rehabilitation Science, University of Kentucky, Lexington, Kentucky. Electronic address: jennifer.mullins@uky.edu.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Hoch', 'Affiliation': 'Department of Rehabilitation Science, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Kosik', 'Affiliation': 'Department of Rehabilitation Science, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Nicholas R', 'Initials': 'NR', 'LastName': 'Heebner', 'Affiliation': 'Department of Rehabilitation Science, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Gribble', 'Affiliation': 'Department of Rehabilitation Science, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'Nitz', 'Affiliation': 'Department of Rehabilitation Science, University of Kentucky, Lexington, Kentucky.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2020.08.001']
3091,33248747,Dry Needling and Photobiomodulation Decreases Myofascial Pain in Trapezius of Women: Randomized Blind Clinical Trial.,"OBJECTIVE
The purpose of this study was to assess whether dry needling (DN) added to photobiomodulation (PBM) has effects on the treatment of active myofascial trigger points in the upper trapezius.
METHODS
This study was a randomized clinical trial, with 43 participants divided into 3 groups: DN and PBM (DNP), DN, and DN outside of the trigger point (DNout). Each group received 1 session of DN followed by PBM therapy with the machine turned on or off. Pain, disability, pain pressure threshold, and muscle activity were assessed before the intervention and afterward at intervals of 10 minutes, 30 minutes, 1 week, and 1 month.
RESULTS
Pain decreased after intervention in the DNP and DNout groups, with mean differences, respectively, of 1.33 cm (95% confidence interval [CI], 0.019-2.647) and 2.78 cm (95% CI, 1.170-2.973). Scores for the disability questionnaire decreased in all groups after intervention (F = 36.53, P < .0001) after the intervention, with mean differences of 3.8 points in the DNP group (95% CI, 1.082-5.518), 3.57 in the DN group (95% CI, 0.994-6.149), and 5.43 in the DNout group (95% CI, 3.101-7.756). There were no significant differences between or within groups in pain pressure threshold (F = 2.14, P = .139), with mean differences after 30 minutes of 0.139 kgf for the DNP group (95% CI, -0.343 to 0.622), 0.273 for the DN group (95% CI, -0.661 to 1.209), and -0.07 for the DNout group (95% CI, -0.465 to 0.324). Muscle activation for the DN group increased 8.49% after the intervention, where for the DNP group it decreased 11.5%, with a significant difference between groups.
CONCLUSION
DN added to PBM presented similar results compared to DNout and DN. In this sample, the effects of the application of DN outside of the trigger point had better effects on pain and disability scores than DN applied directly on the trigger point.",2020,"Scores for the disability questionnaire decreased in all groups after intervention (F = 36.53, P < .0001) after the intervention, with mean differences of 3.8 points in the DNP group (95% CI, 1.082-5.518), 3.57 in the DN group (95% CI, 0.994-6.149), and 5.43 in the DNout group (95% CI, 3.101-7.756).","['Trapezius of Women', '43 participants divided into 3 groups: DN and PBM (DNP), DN, and DN outside of the trigger point (DNout']","['1 session of DN followed by PBM therapy with the machine turned on or off', 'DNP', 'dry needling (DN) added to photobiomodulation (PBM', 'Dry Needling and Photobiomodulation']","['Pain, disability, pain pressure threshold, and muscle activity', 'Myofascial Pain', 'disability questionnaire', 'pain and disability scores', 'Pain', 'Muscle activation', 'pain pressure threshold']","[{'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.148406,"Scores for the disability questionnaire decreased in all groups after intervention (F = 36.53, P < .0001) after the intervention, with mean differences of 3.8 points in the DNP group (95% CI, 1.082-5.518), 3.57 in the DN group (95% CI, 0.994-6.149), and 5.43 in the DNout group (95% CI, 3.101-7.756).","[{'ForeName': 'Ameg', 'Initials': 'A', 'LastName': 'Dalpiaz', 'Affiliation': 'Center of Sciences, Technologies and Health, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Heloyse Uliam', 'Initials': 'HU', 'LastName': 'Kuriki', 'Affiliation': 'Center of Sciences, Technologies and Health, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Renan Andrade Pereira', 'Initials': 'RAP', 'LastName': 'Barbosa', 'Affiliation': 'Center of Sciences, Technologies and Health, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Diefenthaeler', 'Affiliation': 'Center of Sciences, Technologies and Health, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Alexandre Marcio', 'Initials': 'AM', 'LastName': 'Marcolino', 'Affiliation': 'Center of Sciences, Technologies and Health, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Rafael Inacio', 'Initials': 'RI', 'LastName': 'Barbosa', 'Affiliation': 'Center of Sciences, Technologies and Health, Federal University of Santa Catarina, Araranguá, Santa Catarina, Brazil. Electronic address: rafael.barbosa@ufsc.br.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2020.07.002']
3092,33252584,Silicone Oil versus Perfluoropropane Gas Tamponade during Vitrectomy for Tractional Retinal Detachment or Fibrous Proliferation: a Randomized Clinical Trial.,"PURPOSE
To compare vitreous substitution with silicone oil to perfluoropropane (C3F8) gas in proliferative diabetic retinopathy (PDR) subjects undergoing pars plana vitrectomy (PPV) for the treatment of tractional retinal detachment (TRD) or extensive fibrous proliferation.
DESIGN
Randomized clinical trial.
METHODS
Three hundred and two PDR subjects with TRD or extensive fibrous proliferation requiring PPV were enrolled into the trial. Subjects were prospectively randomized into one of two vitreous substitution groups during PPV: Group A subjects underwent 1,000 centistoke silicone oil tamponade, whereas Group B subjects underwent 14-16% C3F8 gas tamponade. The principal outcome was best-corrected visual acuity (BCVA) at 6 months follow up. Secondary outcomes were postoperative complications and unplanned PPV during the 6-month trial interval.
RESULTS
Two hundred and fifty-eight subjects were randomized to receive a vitreous substitute and completed 6 months follow up. Group B had better BCVA, more subjects ending up with 0.4 logMAR (20/50) or better visual acuity, and more subjects ending up with 1 logMAR (20/200) or better visual acuity at 6 months compared to Group A (p< 0.001, p=0.02, p< 0.001, respectively). There were no significant differences in baseline characteristics, intraoperative or postoperative complications, or incidence of unplanned PPV between groups.
CONCLUSIONS
This trial demonstrated that vitreous substitution with C3F8 gas resulted in better visual acuity at 6 months compared to silicone oil tamponade in PDR patients undergoing PPV for TRD or extensive fibrous proliferation. Surgeons should consider C3F8 gas tamponade as the first-line vitreous substitute in this patient population.",2020,"There were no significant differences in baseline characteristics, intraoperative or postoperative complications, or incidence of unplanned PPV between groups.
","['Two hundred and fifty-eight subjects', 'proliferative diabetic retinopathy (PDR) subjects undergoing', 'Tractional Retinal Detachment or Fibrous Proliferation', 'Three hundred and two PDR subjects with TRD or extensive fibrous proliferation requiring PPV', 'PDR patients undergoing PPV for TRD or extensive fibrous proliferation']","['vitreous substitution groups during PPV: Group A subjects underwent 1,000 centistoke silicone oil tamponade', 'silicone oil tamponade', 'Silicone Oil versus Perfluoropropane Gas Tamponade during Vitrectomy', 'pars plana vitrectomy (PPV', 'silicone oil to perfluoropropane (C3F8) gas', 'vitreous substitute']","['corrected visual acuity (BCVA', 'visual acuity', 'postoperative complications and unplanned PPV during the 6-month trial interval', 'baseline characteristics, intraoperative or postoperative complications, or incidence of unplanned PPV']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0154828', 'cui_str': 'Traction detachment of retina'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0334094', 'cui_str': 'Proliferation'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0037111', 'cui_str': 'Silicone oil'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0937858', 'cui_str': 'Perflutren'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0563537', 'cui_str': 'Mechanical vitrectomy by pars plana approach'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",258.0,0.195912,"There were no significant differences in baseline characteristics, intraoperative or postoperative complications, or incidence of unplanned PPV between groups.
","[{'ForeName': 'Ryan B', 'Initials': 'RB', 'LastName': 'Rush', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}, {'ForeName': 'Agustin', 'Initials': 'A', 'LastName': 'Del Valle Penella', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Reinauer', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}, {'ForeName': 'Sloan W', 'Initials': 'SW', 'LastName': 'Rush', 'Affiliation': 'Panhandle Eye Group, 7400 Fleming Ave., Amarillo, Texas 79106, USA.'}, {'ForeName': 'Pedro Gomez', 'Initials': 'PG', 'LastName': 'Bastar', 'Affiliation': 'Instituto de la Visión- Hospital La Carlota, Camino al Vapor #209 Colonia Zambrano Montemorelos, Nuevo León 67530, México.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000003052']
3093,33252568,Systemic supplemental oxygen therapy during accelerated corneal cross-linking for progressive keratoconus; a randomized clinical trial.,"PURPOSE
To investigate the potential additive effect of systemic supplemental oxygen administered during accelerated corneal crosslinking (CXL) for progressive keratoconus (KCN).
SETTING
Department of ophthalmology at an academic center DESIGN:: Randomized Clinical Trial METHODS:: This study includes eyes with progressive KCN ranodmized to three different CXL protocols. The first group (OA-CXL) included 19 eyes that underwent an accelerated CXL protocol (9 mW/ cm2 for 10 minutes) while receiving systemic oxygen at a rate of 5 liters/minute for 10 minutes. The second group consisted of 14 eyes undergoing the same accelerated CXL protocol without supplemental oxygen therapy (A-CXL). The third group (C-CXL) was comprised of 14 eyes undergoing conventional CXL according to the Dresden protocol. All subjects were followed for at least six months. Visual acuity, keratometry and corneal biomechanical parameters including corneal hysteresis (CH) and corneal resistance factor (CRF) were measured preoperatively and 6 months postoperatively.
RESULTS
Reduction in K max was significantly greater in the OA-CXL (P=0.01). At baseline, mean K max was 54.31 ± 3.64 D in the OA-CXL group, 54.66 ± 4.99 D in the A-CXL group and 56.03 ± 5.28 D in the C-CXL group (P=0.58), which reached 53.58 ± 3.24, 54.59 ± 4.65 and 55.87 ± 4.73 D at six months in the three study groups, respectively (P= 0.115). Mean CRF was increased significantly only in the OA-CXL group from a baseline value of 6.32 ± 2.12 to 7.38 ± 1.88 mmHg at 6 months (P=0.009) CONCLUSION:: This study suggests superior efficacy of an accelerated CXL protocol coupled with systemic oxygen supplementation as compared to the accelerated CXL protocol and the conventional protocolin eyes with progressive KCN. . In addition to greater reduction in K max as the primary outcome, improvement in corneal biomechanics was also observed at 6 months.",2020,"RESULTS
Reduction in K max was significantly greater in the OA-CXL (P=0.01).","['eyes with progressive KCN ranodmized to three different CXL protocols', 'Department of ophthalmology at an academic center DESIGN']","['Systemic supplemental oxygen therapy', 'conventional CXL', 'accelerated CXL protocol coupled with systemic oxygen supplementation', 'accelerated CXL protocol', 'systemic supplemental oxygen', '14 eyes undergoing the same accelerated CXL protocol without supplemental oxygen therapy (A-CXL', 'OA-CXL']","['corneal biomechanics', 'Mean CRF', 'Visual acuity, keratometry and corneal biomechanical parameters including corneal hysteresis (CH) and corneal resistance factor (CRF', 'K max']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034471', 'cui_str': 'R factor'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",14.0,0.0771965,"RESULTS
Reduction in K max was significantly greater in the OA-CXL (P=0.01).","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Faramarzi', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Hassanpour', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Baharan', 'Initials': 'B', 'LastName': 'Rahmani', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Yazdani', 'Affiliation': 'Ophthalmic Epidemiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Kheiri', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad-Mehdi', 'Initials': 'MM', 'LastName': 'Sadoughi', 'Affiliation': 'Ophthalmic Research Center, Research Institute for Ophthalmology and Vision Science, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000513']
3094,33252564,Corneal Endothelial Damage in Phacoemulsification Using an Anterior Chamber Maintainer Compared to Using an Ophthalmic Viscosurgical Device.,"PURPOSE
To compare the effects of phacoemulsification surgery (PE) using an anterior chamber maintainer (ACM) and conventional PE using an ophthalmic viscosurgical device (OVD) on corneal endothelial cells.
SETTING
Department of Ophthalmology, Celal Bayar University, Manisa,Turkey.
DESIGN
Prospective randomized controlled trial.
METHODS
This study included 100 eyes of 97 patients undergoing PE. Eyes in the OVD group (n=50) underwent conventional PE, while eyes in the ACM group (n=50) underwent PE using an ACM. Endothelial cell density (ECD), coefficient of variation (CV), hexagonality (HEX) and non-contact central corneal thickness (CCT) measurements were performed by specular microscopy (SM) before and at 1, 3, and 6 months after PE.
RESULTS
Mean age was 64.7 ± 10.6 in the OVD group, 64.0 ± 12.6 in the ACM group (p>0.05). The groups did not differ significantly in terms of preoperative ECD, CV, HEX, and CCT or total PE time (p>0.05 for all). ECD was significantly lower in the ACM group compared to the OVD group at postoperative 1, 3, and 6 months (p=0.002, p=0.002, p=0.001). Similarly, ECD loss compared to preoperative value was greater in the ACM group at all postoperative time points (p=0.003, p=0.001, p=0.001). CV increased and HEX decreased in both groups postoperatively (p>0.05 for both). CCT showed a transient increase of less than 10 μm at postoperative 1 month in both groups (p=0.296).
CONCLUSION
PE with ACM was associated with greater corneal ECD loss compared to conventional PE. ACM should not be used during PE in patients with limited corneal endothelial reserve.",2020,"ECD was significantly lower in the ACM group compared to the OVD group at postoperative 1, 3, and 6 months (p=0.002, p=0.002, p=0.001).","['Eyes in the OVD group', 'patients with limited corneal endothelial reserve', 'Department of Ophthalmology, Celal Bayar University, Manisa,Turkey', '100 eyes of 97 patients undergoing PE', 'Mean age was 64.7 ± 10.6 in the OVD group, 64.0 ± 12.6 in the ACM group (p>0.05']","['Phacoemulsification Using an Anterior Chamber Maintainer', 'PE using an ACM', 'CCT', 'phacoemulsification surgery (PE', 'ACM', 'anterior chamber maintainer (ACM) and conventional PE using an ophthalmic viscosurgical device (OVD', 'conventional PE, while eyes in the ACM']","['ECD', 'preoperative ECD, CV, HEX, and CCT or total PE time', 'ECD loss', 'Corneal Endothelial Damage', 'Endothelial cell density (ECD), coefficient of variation (CV), hexagonality (HEX) and non-contact central corneal thickness (CCT) measurements', 'CV increased and HEX', 'corneal ECD loss']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}]","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",97.0,0.0430563,"ECD was significantly lower in the ACM group compared to the OVD group at postoperative 1, 3, and 6 months (p=0.002, p=0.002, p=0.001).","[{'ForeName': 'Huseyin', 'Initials': 'H', 'LastName': 'Mayali', 'Affiliation': 'Assistant Professor.'}, {'ForeName': 'Esin Fatma', 'Initials': 'EF', 'LastName': 'Baser', 'Affiliation': 'Prof. Dr.'}, {'ForeName': 'Emin', 'Initials': 'E', 'LastName': 'Kurt', 'Affiliation': 'Prof. Dr.'}, {'ForeName': 'Suleyman Sami', 'Initials': 'SS', 'LastName': 'Ilker', 'Affiliation': 'Prof. Dr.'}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000493']
3095,33252553,Levels of Urgency for Orthopaedic Procedures: Reliability and Adoption of a Consensus-driven Classification.,"INTRODUCTION
The current COVID-19 disease pandemic has delayed nonurgent orthopaedic procedures to adequately care for those affected by the severe acute respiratory syndrome coronavirus 2, resulting in a backlog in orthopaedic surgical care. As the capacity for orthopaedic surgeries expands or contracts, allocation of limited resources in a manner that adequately reflects medical necessity and urgency is paramount. An orthopaedic surgery-specific prioritization schema with proven reliability is lacking. The primary aim of this study was to assess the reliability of a newly developed prioritization list used for the phased reinstatement of orthopaedic surgical procedures during the COVID-19 pandemic and afterward. The secondary aim was to report its implementation.
METHODS
A consensus-based, orthopaedic surgery-specific, tiered prioritization list reflecting various levels of urgency was created by a committee of orthopaedic surgeons covering all subspecialties and representing academic, multispecialty, and private community practices. Reliability was tested for 63 randomized cases representing all orthopaedic subspecialties. Four raters evaluated the cases independently at two separate time points, at least one week apart. Fleiss kappa was used to assess intrarater and interrater agreement. Implementation were assessed by surveying both surgeons and the surgery scheduling administrative personnel at each surgical facility within a large health system for any adoption issues.
RESULTS
Case distributions within tiers 1, 2, 3, and 4 were 35%, 14%, 27%, and 24%, respectively. Interrater agreement ranged from 0.63 (95% confidence interval [CI] 0.57 to 0.69) to 0.72 (95% CI 0.66 to 0.78) for the ratings. Intrarater reliability ranged from 0.62 to 1.0. The highest levels of agreement were in tiers 1, 4, and the subspecialties oncology and foot/ankle. The time from development to full scale adoption and implementation by all orthopaedic surgeons was rapid.
DISCUSSION
This tiered prioritization list for orthopaedic procedures is both adoptable and reliable during the phased reinstatement of procedures during the COVID-19 pandemic and afterward. Further refinements may enhance utility.
LEVELS OF EVIDENCE
Reliability study: Level I (Evid Based Spine Care J 2014 October;5(2):166. doi: 10.1055/s-0034-1394106).",2020,Interrater agreement ranged from 0.63 (95% confidence interval [CI] 0.57 to 0.69) to 0.72 (95% CI 0.66 to 0.78) for the ratings.,['63 randomized cases representing all orthopaedic subspecialties'],[],['Intrarater reliability'],"[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}]",[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0334174,Interrater agreement ranged from 0.63 (95% confidence interval [CI] 0.57 to 0.69) to 0.72 (95% CI 0.66 to 0.78) for the ratings.,"[{'ForeName': 'Edward Y', 'Initials': 'EY', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Orthopedic Surgery, University of Minnesota, and M Health Fairview Hospitals, Minneapolis, MN.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Matson', 'Affiliation': ''}, {'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Morgenstern', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Agel', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hoogervorst', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-20-00631']
3096,33252552,Dual Mobility Cup: Does It Improve Patient's Satisfaction After Total Hip Arthroplasty? A Prospective Comparative Randomized Study.,"INTRODUCTION
Despite the great success of total hip arthroplasty (THA), many patients were fairly dissatisfied after surgery. Therefore, patient-reported outcome measures have become of an utmost importance in assessing the results after joint replacement. This study was conducted to compare the postoperative patient-reported satisfactions after implantation of two commonly used THA designs.
METHODS
Of 180 patients, who initially fulfilled the study selection criteria and received cementless THA, 165 patients were finally eligible and enrolled in this prospective comparative randomized study. All surgeries were carried out between 2010 and 2018. Two groups of homogenous demographic and clinical data were present. Group A patients (n = 80) were treated by large head THA, whereas group B (n = 85) received dual mobility cup designs. The Western Ontario McMaster Universities Osteoarthritis Index and visual analog scale were used for clinical evaluation. The degree of improvement that the patient expected and hoped before undergoing their surgeries was estimated using the score of the new knee society. The self-administered patient satisfaction scale was used to record the levels of patient satisfaction after surgery, and their values were statistically analyzed in relation to preoperative expectation scores (ie, score of the new knee society) and different clinical and sociodemographic variables.
RESULTS
After a mean follow-up of 79 ± 4.13 months (range 24 to 96 months), both groups recorded a significant improvement (P < 0.05) in Western Ontario McMaster Universities Osteoarthritis Index and visual analogue scale scores. Patients of group B were significantly more satisfied (P < 0.05) than those of group A up to the first postoperative year. Certain studied variables were linked to superior satisfaction results among group B at the last follow-up.
CONCLUSIONS
Dual mobility THA provides better patient satisfaction than their standard large head alternatives specifically among elderly patients, socially unsupported individuals, farmers, heavy manual workers, and those with high levels of expectations.
CLINICAL TRIAL REGISTRATION
Clinical Trials.gov identifier: NCT04333316.",2020,Patients of group B were significantly more satisfied (P < 0.05) than those of group A up to the first postoperative year.,"['Of 180 patients, who initially fulfilled the study selection criteria and received', '165 patients were finally eligible and enrolled']","['cementless THA', 'Dual mobility THA', 'total hip arthroplasty (THA', 'Dual Mobility Cup', 'dual mobility cup designs']","['Western Ontario McMaster Universities Osteoarthritis Index and visual analogue scale scores', 'patient satisfaction', 'Western Ontario McMaster Universities Osteoarthritis Index and visual analog scale']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C4319555', 'cui_str': '165'}]","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",80.0,0.0265381,Patients of group B were significantly more satisfied (P < 0.05) than those of group A up to the first postoperative year.,"[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Samy', 'Affiliation': 'From the Orthopedic Department, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ashraf Atef', 'Initials': 'AA', 'LastName': 'Mahmoud', 'Affiliation': ''}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'El-Tantawy', 'Affiliation': ''}]",The Journal of the American Academy of Orthopaedic Surgeons,['10.5435/JAAOS-D-20-00882']
3097,33252379,"Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study.","BACKGROUND
Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.
METHODS
We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.
RESULTS
At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.
CONCLUSIONS
The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.",2020,"The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration.","['patients with first-line treatment failure', 'HIV-1-infected adults already treated with antiretroviral drugs', 'Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL', 'antiretroviral-experienced adults with human immunodeficiency virus-1', '12 sites in China']","['ritonavir-boosted lopinavir', 'tenofovir disoproxil fumarate', 'albuvirtide plus lopinavir-ritonavir', 'long-acting fusion inhibitor albuvirtide', 'albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group']","['safety and efficacy', 'diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration', 'Efficacy and safety', 'proportion of patients with a plasma viral load', 'frequency of grade 3 to 4 adverse events', 'Renal function', 'HIV-1 RNA levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C3493164', 'cui_str': 'albuvirtide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1275666', 'cui_str': 'Fusion inhibitor'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0045246', 'cui_str': ""2,2'-azino-di-(3-ethylbenzothiazoline)-6-sulfonic acid""}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.193702,"The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration.","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Su', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Qing-Xia', 'Initials': 'QX', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Diseases, Infectious Disease Hospital of Henan Province, Zhengzhou, Henan 450061, China.'}, {'ForeName': 'Wei-Ping', 'Initials': 'WP', 'LastName': 'Cai', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510060, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Institute of HIV/AIDS, The First Hospital of Changsha, Changsha, Hunan 410005, China.'}, {'ForeName': 'Hong-Zhou', 'Initials': 'HZ', 'LastName': 'Lu', 'Affiliation': 'Department of Infectious Diseases, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Infectious Disease Hospital of Henan Province, Zhengzhou, Henan 450061, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Infectious Diseases, Shanghai Public Health Clinical Center, Fudan University, Shanghai 201508, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Infectious Diseases, National Clinical Center for Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Infectious Diseases, National Clinical Center for Infectious Diseases, Shenzhen Third People's Hospital, Shenzhen, Guangdong 518112, China.""}, {'ForeName': 'Yu-Huang', 'Initials': 'YH', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, Hunan 410011, China.'}, {'ForeName': 'Ling-Hua', 'Initials': 'LH', 'LastName': 'Li', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510060, China.""}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Chen', 'Affiliation': ""Infectious Disease Center, Guangzhou Eighth People's Hospital, Guangzhou Medical University, Guangzhou, Guangdong 510060, China.""}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Yu', 'Affiliation': 'Department of Infectious Diseases, Xixi Hospital of Hangzhou, Hangzhou, Zhejiang 310023, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou, Zhejiang 310003, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center for Infectious Diseases, the Fifth Medical Center of PLA General Hospital, Beijing 100039, China.'}, {'ForeName': 'Yong-Tao', 'Initials': 'YT', 'LastName': 'Sun', 'Affiliation': ""Department of Infectious Diseases, Tangdu Hospital, The Fourth Military Medical University, Xi'an, Shaanxi 710038, China.""}, {'ForeName': 'Wen-Hui', 'Initials': 'WH', 'LastName': 'Lun', 'Affiliation': 'Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xia', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Sun', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Dai', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Tai-Yi', 'Initials': 'TY', 'LastName': 'Jiang', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Mei-Xia', 'Initials': 'MX', 'LastName': 'Wang', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Qing-Shan', 'Initials': 'QS', 'LastName': 'Zheng', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Peng', 'Affiliation': 'Beijing Co-CRO Medical Development Co., Ltd., Beijing 100711, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Beijing Co-CRO Medical Development Co., Ltd., Beijing 100711, China.'}, {'ForeName': 'Rong-Jian', 'Initials': 'RJ', 'LastName': 'Lu', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Hu', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': 'State Key Laboratory for Infectious Disease Prevention and Control, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Shao', 'Affiliation': 'State Key Laboratory for Infectious Disease Prevention and Control, National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Xie', 'Affiliation': 'Frontier Biotechnologies Inc., Nanjing, Jiangsu 211122, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': 'Fu-Jie', 'Initials': 'FJ', 'LastName': 'Zhang', 'Affiliation': 'Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000001273']
3098,33252361,Response: Primary Open versus Closed Implantation Strategy for Totally Implantable Venous Access Ports: The Multicenter Randomized Controlled PORTAS-3 trial (DRKS 00004900).,,2020,,[],['Open versus Closed Implantation Strategy'],[],[],"[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",[],,0.106935,,"[{'ForeName': 'Felix J', 'Initials': 'FJ', 'LastName': 'Hüttner', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany Study Center of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany Study Center of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany Study Center of the German Surgical Society (SDGC), University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': ''}, {'ForeName': 'Markus K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': ''}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': ''}]",Annals of surgery,['10.1097/SLA.0000000000004406']
3099,33252348,The Role of Enjoyment in a Serious Game for Binge Drinking Prevention: Pretest-Posttest Quasi-Experimental Study.,"BACKGROUND
Although binge drinking peaks at age 21 to 25 years, there is limited research on the effects of serious games in this population, as well as on the process by which playing serious games impacts alcohol-related outcomes. Designed with both health behavioral theory and game theory, One Shot is an online serious game that aims to prevent binge drinking.
OBJECTIVE
This study utilized a conceptual model for serious video game processes. Using One Shot, the model assessed the following process stages: (1) Alcohol Use Disorders Identification Test-Concise (AUDIT-C); (2) in-game factors of game time and risky alcohol decisions; (3) game enjoyment; and (4) postgame outcomes of intention to drink less and drinking refusal self-efficacy.
METHODS
In a one-group pretest-posttest quasi-experimental design, a sample (N=550) of young adults (age 21-25 years) who reported recent binge drinking played the One Shot game. Intention to drink less and drinking refusal self-efficacy were measured at pregame and postgame, with their effects lagged in statistical analysis. Participants were presented with various scenarios in the game that pertained to risky alcohol decisions, which, along with game time, were unobtrusively recorded by the server. A structural equation model (SEM) was used to test the conceptual model, with assessments made to determine if enjoyment mediated the effects of game time and risky alcohol decisions on the 2 postgame alcohol-related outcomes.
RESULTS
A well-fitting SEM demonstrated support for the multistep model, with AUDIT-C predicting risky alcohol decisions (β=.30). Risky alcohol decisions (β=-.22) and game time (β=.18) predicted enjoyment, which, in turn, predicted intention to drink less (β=.21) and drinking refusal self-efficacy (β=.16). Enjoyment significantly (P<.001) mediated the effects of game time and risky alcohol decision on intention to drink less and drinking refusal self-efficacy.
CONCLUSIONS
The results support a conceptual model in which staggered individual and in-game factors influence alcohol-related outcomes. Enjoyment is important for participants' intentions to drink less and beliefs that they can refuse alcohol.",2020,"Enjoyment significantly (P<.001) mediated the effects of game time and risky alcohol decision on intention to drink less and drinking refusal self-efficacy.
",['young adults (age 21-25 years) who reported recent binge drinking played the One Shot game'],[],"['game time and risky alcohol decision on intention to drink less and drinking refusal self-efficacy', 'Risky alcohol decisions', 'drinking refusal self-efficacy', 'intention to drink less and drinking refusal self-efficacy', 'Intention to drink less and drinking refusal self-efficacy']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0040809', 'cui_str': 'Refusal of treatment by patient'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0163468,"Enjoyment significantly (P<.001) mediated the effects of game time and risky alcohol decision on intention to drink less and drinking refusal self-efficacy.
","[{'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Hong', 'Affiliation': 'College of Communication, Boston University, Boston, MA, United States.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cabrera', 'Affiliation': 'MHMR Authority of Brazos Valley, Bryan, TX, United States.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Beaudoin', 'Affiliation': 'College of Communication, Boston University, Boston, MA, United States.'}]",Journal of medical Internet research,['10.2196/21652']
3100,33252344,Long-Term Follow-Up of a Randomized Controlled Trial to Reduce Excessive Weight Gain in Infancy: Protocol for the Prevention of Overweight in Infancy (POI) Follow-Up Study at 11 Years.,"BACKGROUND
The Prevention of Overweight in Infancy (POI) randomized controlled trial assessed the effect of a more conventional food, physical activity, and breastfeeding intervention, with a more novel sleep intervention on weight outcomes at 2 years of age. The trial had 58% uptake at recruitment, and retention was 86% at age 2 years, 77% at age 3.5 years, and 69% at age 5 years. Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention. Importantly, this substantially reduced risk was still apparent at our follow-up at 5 years of age.
OBJECTIVE
The primary aim of this follow-up at age 11 years is to determine whether differences in BMI z-score and obesity risk remain apparent now that it is at least 9 years since cessation of the sleep intervention. Several secondary outcomes of interest will also be examined including 24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep.
METHODS
We will seek renewed consent from all 734 of the original 802 POI families who expressed interest in further involvement. Children and parent(s) will attend 2 clinics and 1 home appointment to obtain measures of anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires).
RESULTS
This follow-up study has full ethical approval from the University of Otago Human Ethics Committee (H19/109) and was funded in May 2019 by the Health Research Council of New Zealand (grant 19/346). Data collection commenced in June 2020, and first results are expected to be submitted for publication in 2022.
CONCLUSIONS
Long-term outcomes of early obesity intervention are rare. Despite the growing body of evidence linking insufficient sleep with an increased risk of obesity in children, interventions targeting improvements in sleep have been insufficiently explored. Our initial follow-up at 5 years of age suggested that an early sleep intervention may have long-term benefits for effective weight management in children. Further analysis in our now preteen population will provide much-needed evidence regarding the long-term effectiveness of sleep interventions in infancy as an obesity prevention approach.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00892983; https://tinyurl.com/y3xepvxf.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/24968.",2020,Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention.,"['children', '734 of the original 802 POI families who expressed interest in further involvement', 'The trial had 58% uptake at recruitment, and retention was 86% at age 2 years, 77% at age 3.5 years, and 69% at age 5 years', 'at 2 years of age', 'Overweight in Infancy (POI) Follow-Up Study at 11 Years', 'Infancy']","['brief sleep intervention', 'conventional food, physical activity, and breastfeeding intervention, with a more novel sleep intervention']","['weight outcomes', 'BMI z-score and obesity risk', 'anthropometry and body composition (dual-energy x-ray absorptiometry scan), 24-hour movement patterns (sleep, sedentary time, and physical activity measured using an AX3 accelerometer), mental health and wellbeing (validated questionnaires), family functioning (validated questionnaires), use of electronic media (wearable and stationary cameras, questionnaires), and diet and eating behaviors (24-hour recall, questionnaires', '24-hour movement patterns, mental health and wellbeing, and use of electronic media, particularly prior to sleep']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0347980', 'cui_str': '% uptake'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",802.0,0.0811814,Children who received the brief sleep intervention in infancy had just half the risk of obesity at 2 years of age compared to those who did not receive the sleep intervention.,"[{'ForeName': 'Taiwo O', 'Initials': 'TO', 'LastName': 'Adebowale', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Taylor', 'Affiliation': ""Department of Women's and Children's Health, Children's Pavilion Dunedin Public Hospital, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gray', 'Affiliation': 'Biostatistics Centre, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand.""}, {'ForeName': 'Anne-Louise M', 'Initials': 'AM', 'LastName': 'Heath', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fortune', 'Affiliation': 'Department of Psychological Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Meredith-Jones', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Trudy', 'Initials': 'T', 'LastName': 'Sullivan', 'Affiliation': 'Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'McIntosh', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Brosnan', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, University of Otago, Dunedin, New Zealand.'}]",JMIR research protocols,['10.2196/24968']
3101,33252282,Surgery of metastatic melanoma after systemic therapy - the SUMMIST trial: study protocol for a randomized controlled trial.,,2020,,[],[],[],[],[],[],,0.477117,,"[{'ForeName': 'Carl Jacob', 'Initials': 'CJ', 'LastName': 'Holmberg', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Katsarelias', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Jespersen', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Carneiro', 'Affiliation': 'Department of Oncology, Lund University Hospital, Lund, Sweden.'}, {'ForeName': 'Nils O', 'Initials': 'NO', 'LastName': 'Elander', 'Affiliation': 'Department of Oncology and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hildur', 'Initials': 'H', 'LastName': 'Helgadottir', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Karolin', 'Initials': 'K', 'LastName': 'Isaksson', 'Affiliation': 'Department of Clinical Sciences, Surgery, Lund University, Lund, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Jansson', 'Affiliation': 'Department of Surgical and Perioperative Sciences, Umeå University and Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Wirén', 'Affiliation': 'Department of Radiation Sciences, Oncology, Umeå University Hospital, Umeå, Sweden.'}, {'ForeName': 'Gustav J', 'Initials': 'GJ', 'LastName': 'Ullenhag', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Science of Life Laboratory, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Ny', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Olofsson Bagge', 'Affiliation': 'Department of Surgery, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1846213']
3102,33252241,Effect of Equine-Assisted Activities on Cardiac Autonomic Function in Children with Cerebral Palsy: A Pilot Randomized-Controlled Trial.,"Objective: Children with cerebral palsy (CP) have an impaired cardiac autonomic function. Attenuated heart rate recovery (HRR), which is a valuable prognostic parameter for autonomic nervous system, is known to be associated with an increased risk of cardiovascular events and all-cause mortality. However, only few studies have observed the effects of exercise on the cardiac autonomic function in children with CP. The purpose of this pilot study was to examine the effects of equine-assisted activity (EAA) program on cardiac autonomic function in children with CP. Design: A single-blinded, parallel, two-arm pilot trial with 1:1 randomization to the EAA or control group. Setting: A tertiary university hospital and a local arena. Subjects: Twenty-six children with CP (Gross Motor Function Classification System Levels I-II). Intervention: Each lesson of the EAA program for the EAA group was conducted for 40 min twice a week, and the whole program duration was 16 weeks (a total of 32 sessions). Outcome measures: A graded exercise test was performed to measure the resting heart rate (RHR), HRR, and peak oxygen uptake (VO 2peak ) on both groups before and after the 16-week period. Results: The autonomic nervous function measured by the response of HRR improved at 1 min ( p < 0.009), 3 min ( p < 0.001), and 5 min ( p < 0.004) only in the EAA group. RHR significantly improved in the EAA group ( p < 0.013), whereas the VO 2peak did not significantly differ between the two groups. Conclusion: The HRR and RHR of the children with CP improved after completing the 16-week EAA program. The results demonstrated that the program had a positive effect on the improvement of cardiac autonomic function in these patients. Clinical Trial Registration Number: NCT03870893.",2020,"The autonomic nervous function measured by the response of HRR improved at 1 min ( p < 0.009), 3 min ( p < 0.001), and 5 min ( p < 0.004) only in the EAA group.","['Children with cerebral palsy (CP', 'children with CP', 'Subjects: Twenty-six children with CP', 'Setting: A tertiary university hospital and a local arena', 'Children with Cerebral Palsy']","['EAA or control group', 'EAA', 'Equine-Assisted Activities', 'equine-assisted activity (EAA) program']","['resting heart rate (RHR), HRR, and peak oxygen uptake (VO 2peak ', 'cardiac autonomic function', 'RHR', 'autonomic nervous function', 'VO 2peak', 'heart rate recovery (HRR', 'HRR', 'HRR and RHR of the children with CP', 'Cardiac Autonomic Function']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0243046', 'cui_str': 'Excitatory Amino Acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",26.0,0.0279369,"The autonomic nervous function measured by the response of HRR improved at 1 min ( p < 0.009), 3 min ( p < 0.001), and 5 min ( p < 0.004) only in the EAA group.","[{'ForeName': 'In-Kyeong', 'Initials': 'IK', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Samsung Equestrian Team, Gunpo, Republic of Korea.'}, {'ForeName': 'Min-Hwa', 'Initials': 'MH', 'LastName': 'Suk', 'Affiliation': 'Department of Sport Science, College of Sport and Art, Hanyang University, Seoul, Republic of Korea.'}, {'ForeName': 'Soojin', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Health and Human Performance, University of Texas, Rio Grande Valley, Edinburg, TX, USA.'}, {'ForeName': 'Yong-Gon', 'Initials': 'YG', 'LastName': 'Seo', 'Affiliation': 'Division of Sports Medicine, Department of Orthopedic Surgery, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jea-Keun', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Department of Health Care and Sports Science, Korea National Sport University, Seoul, Republic of Korea.'}, {'ForeName': 'Jeong-Yi', 'Initials': 'JY', 'LastName': 'Kwon', 'Affiliation': 'Department of Physical & Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2020.0346']
3103,32057905,On the usefulness of compendial setups and tiny-TIM system in evaluating the in vivo performance of oral drug products with various release profiles in the fasted state: Case example sodium salt of A6197.,"We evaluated the usefulness of quality control dissolution data collected with compendial Apparatus I and II, biorelevant dissolution data collected with compendial apparatus IV, and bioaccessibility data collected with the non-compendial tiny-TIM system in screening modified release formulations during the development of BCS Class I compounds using a Boehringer Ingelheim model experimental compound, A6197. Four products were investigated: an immediate release tablet, an extended release tablet, modified release mini-tablets, and extended release pellets. Data with modified release products collected with the compendial apparatus were evaluated vs. the average intraluminal dissolution estimated after deconvoluting clinical data collected in healthy adults. Data collected with the tiny-TIM system were evaluated vs. the average AUC and C max values estimated from the clinical data. Unlike with the quality control data collected with Apparatus I and II, data collected with Apparatus IV data and Level I biorelevant media adequately described the intraluminal dissolution process of the three modified release products. Data deviated less than 10% from the actual average deconvoluted intraluminal dissolution profiles, illustrating the usefulness of Apparatus IV biorelevant data in understanding the intraluminal dissolution process of BCS class I small molecules administered as modified release products in the fasted state. Total bioaccessibility data and maximum bioaccessibility data collected using the tiny-TIM and the immediate release tablet and the three modified release drug products correctly reproduced the ranking of A6197 AUC values (R 2 = 0.989) and C max values (R 2 = 0.962), respectively, illustrating tiny-TIM as a useful system for formulation selection of BCS class I small molecules administered in the fasted state.",2020,"Four products were investigated: an immediate release tablet, an extended release tablet, modified release mini-tablets, and extended release pellets.",['healthy adults'],['compendial setups and tiny-TIM system'],"['average intraluminal dissolution', 'Total bioaccessibility data and maximum bioaccessibility data']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0429928', 'cui_str': 'Test time'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0442115', 'cui_str': 'Intraluminal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",4.0,0.0222636,"Four products were investigated: an immediate release tablet, an extended release tablet, modified release mini-tablets, and extended release pellets.","[{'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Schilderink', 'Affiliation': 'Triskelion B.V., Zeist, the Netherlands.'}, {'ForeName': 'Marianella', 'Initials': 'M', 'LastName': 'Protopappa', 'Affiliation': 'Department of Pharmacy, School of Health Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Jeannine', 'Initials': 'J', 'LastName': 'Fleth-James', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vertzoni', 'Affiliation': 'Department of Pharmacy, School of Health Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schaefer', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Havenaar', 'Affiliation': 'Triskelion B.V., Zeist, the Netherlands.'}, {'ForeName': 'Ivonne', 'Initials': 'I', 'LastName': 'Kulla', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Metzger', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Reppas', 'Affiliation': 'Department of Pharmacy, School of Health Science, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: reppas@pharm.uoa.gr.'}]",European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V,['10.1016/j.ejpb.2020.02.003']
3104,32369570,Efficacy of Nonsurgical Mechanical Debridement With and Without Adjunct Low-Level Laser Therapy in the Treatment of Peri-Implantitis: A Randomized Controlled Trial.,"We hypothesized that in the long term (6-month follow-up), nonsurgical mechanical debridement (NSMD) with adjunct low-level laser therapy (LLLT) is more effective for the treatment of peri-implantitis than NSMD alone. The aim of the present 6-month follow-up convenience-sample cohort study was to assess the efficacy of LLLT as an adjunct to NSMD in the treatment of peri-implantitis. A questionnaire was used to collect demographic information. Patients with peri-implantitis in the test and control groups underwent NSMD with and without adjunct LLLT, respectively. Randomization was done by tossing a coin. In the test group, the laser was applied perpendicular to the periodontal pocket for 20 seconds at a constant distance of 15 mm and with a continuous wavelength (3.41 J/cm2 delivery with a 1.76 cm2 spot and average output of 0.3 W). In both groups, peri-implant probing depth, bleeding upon probing, and crestal bone resorption were assessed at baseline and at the 3-month and 6-month follow-up. Group comparisons were performed, and P < .05 was considered statistically significant. Sixty-seven individuals with peri-implantitis were included. The mean age of participants who underwent NSMD with adjunct LLLT and NSMD alone was 46.5 ± 3.4 and 45.3 ± 1.1 years, respectively. At the 3- and 6-month follow-up, peri-implant (P < .05), bleeding upon probing (P < .05), and probing depth (P < .05) were significantly higher among patients who underwent NSMD alone compared with patients who underwent NSMD with adjunct LLLT. There was no significant difference in crestal bone resorption in all patients up to the 6-month follow-up. In the short term, NSMD with adjunct LLLT was a useful treatment protocol for the treatment of peri-implant soft-tissue inflammation.",2020,"At the 3- and 6-month follow-up, peri-implant (P < .05), bleeding upon probing (P < .05), and probing depth (P < .05) were significantly higher among patients who underwent NSMD alone compared with patients who underwent NSMD with adjunct LLLT.","['Sixty-seven individuals with peri-implantitis were included', 'mean age of participants who underwent NSMD with adjunct LLLT and NSMD alone was 46.5 ± 3.4 and 45.3 ± 1.1 years, respectively', 'Peri-Implantitis']","['NSMD with adjunct LLLT', 'NSMD with and without adjunct LLLT', 'With and Without Adjunct Low-Level Laser Therapy', 'Nonsurgical Mechanical Debridement', 'LLLT', 'nonsurgical mechanical debridement (NSMD) with adjunct low-level laser therapy (LLLT']","['crestal bone resorption', 'probing depth', 'peri-implant probing depth, bleeding upon probing, and crestal bone resorption', 'bleeding upon probing']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",67.0,0.0321266,"At the 3- and 6-month follow-up, peri-implant (P < .05), bleeding upon probing (P < .05), and probing depth (P < .05) were significantly higher among patients who underwent NSMD alone compared with patients who underwent NSMD with adjunct LLLT.","[{'ForeName': 'Fawaz', 'Initials': 'F', 'LastName': 'Alqahtani', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Nasser', 'Initials': 'N', 'LastName': 'Alqhtani', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Diagnostic Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi-Arabia.'}, {'ForeName': 'Sree Lalita', 'Initials': 'SL', 'LastName': 'Celur', 'Affiliation': 'Oral and Maxillofacial Surgery Division, College of Dentistry, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Darshan Devang', 'Initials': 'DD', 'LastName': 'Divakar', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulaziz A', 'Initials': 'AA', 'LastName': 'Al-Kheraif', 'Affiliation': 'Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alkhtani', 'Affiliation': 'Department of Prosthodontics, College of Dentistry, Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",The Journal of oral implantology,['10.1563/aaid-joi-D-19-00367']
3105,32355285,Replication and Refinement of an Algorithm for Automated Drusen Segmentation on Optical Coherence Tomography.,"Here, we investigate the extent to which re-implementing a previously published algorithm for OCT-based drusen quantification permits replicating the reported accuracy on an independent dataset. We refined that algorithm so that its accuracy is increased. Following a systematic literature search, an algorithm was selected based on its reported excellent results. Several steps were added to improve its accuracy. The replicated and refined algorithms were evaluated on an independent dataset with the same metrics as in the original publication. Accuracy of the refined algorithm (overlap ratio 36-52%) was significantly greater than the replicated one (overlap ratio 25-39%). In particular, separation of the retinal pigment epithelium and the ellipsoid zone could be improved by the refinement. However, accuracy was still lower than reported previously on different data (overlap ratio 67-76%). This is the first replication study of an algorithm for OCT image analysis. Its results indicate that current standards for algorithm validation do not provide a reliable estimate of algorithm performance on images that differ with respect to patient selection and image quality. In order to contribute to an improved reproducibility in this field, we publish both our replication and the refinement, as well as an exemplary dataset.",2020,Accuracy of the refined algorithm (overlap ratio 36-52%) was significantly greater than the replicated one (overlap ratio 25-39%).,[],[],[],[],[],[],,0.0231055,Accuracy of the refined algorithm (overlap ratio 36-52%) was significantly greater than the replicated one (overlap ratio 25-39%).,"[{'ForeName': 'Maximilian W M', 'Initials': 'MWM', 'LastName': 'Wintergerst', 'Affiliation': 'Department of Ophthalmology, University Hospital Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Germany.'}, {'ForeName': 'Shekoufeh', 'Initials': 'S', 'LastName': 'Gorgi Zadeh', 'Affiliation': 'Department of Computer Science, University of Bonn, Endenicher Allee 19a, 53115, Bonn, Germany.'}, {'ForeName': 'Vitalis', 'Initials': 'V', 'LastName': 'Wiens', 'Affiliation': 'Department of Computer Science, University of Bonn, Endenicher Allee 19a, 53115, Bonn, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Thiele', 'Affiliation': 'Department of Ophthalmology, University Hospital Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schmitz-Valckenberg', 'Affiliation': 'Department of Ophthalmology, University Hospital Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Germany.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'Department of Ophthalmology, University Hospital Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Germany.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Finger', 'Affiliation': 'Department of Ophthalmology, University Hospital Bonn, Ernst-Abbe-Str. 2, 53127, Bonn, Germany. robert.finger@ukbonn.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schultz', 'Affiliation': 'Department of Computer Science, University of Bonn, Endenicher Allee 19a, 53115, Bonn, Germany.'}]",Scientific reports,['10.1038/s41598-020-63924-6']
3106,32346001,The Natural history of Epicardial Adipose Tissue Volume and Attenuation: A long-term prospective cohort follow-up study.,"Epicardial adipose tissue (EAT) is associated with cardiovascular risk. The longitudinal change in EAT volume (EATv) and density (EATd), and potential modulators of these parameters, has not been described. We prospectively recruited 90 patients with non-obstructive coronary atherosclerosis on baseline computed tomography coronary angiography (CTCA) performed for suspected coronary artery disease to undergo a repeat research CTCA. EATv in millilitres (mL) and EATd in Hounsfield units (HU) were analysed and multivariable regression analysis controlling for traditional cardiovascular risk factors (CVRF) performed to assess for any predictors of change. Secondary analysis was performed based on statin therapy. The median duration between CTCA was 4.3years. Mean EATv increased at follow-up (72 ± 33 mL to 89 ± 43 mL, p < 0.001) and mean EATd decreased (baseline -76 ± 6 HU vs. -86 ± 5 HU, p < 0.001). There were no associations between baseline variables of body mass index, age, sex, hypertension, hyperlipidaemia, diabetes or smoking on change in EATv or EATd. No difference in baseline, follow-up or delta EATv or EATd was seen in patients with (60%) or without baseline statin therapy. In this select group of patients, EATv consistently increased and EATd consistently decreased at long-term follow-up and these changes were independent of CVRF, age and statin use. Together with the knowledge of strong associations between EAT and cardiac disease, these findings may suggest that EAT is an independent parameter rather than a surrogate for cardiovascular risk.",2020,"Mean EATv increased at follow-up (72 ± 33 mL to 89 ± 43 mL, p < 0.001) and mean EATd decreased (baseline -76 ± 6 HU vs. -86 ± 5 HU, p < 0.001).",['90 patients with non-obstructive coronary atherosclerosis on baseline computed tomography coronary angiography (CTCA) performed for suspected coronary artery disease to undergo a repeat research CTCA'],"['EAT', 'Epicardial adipose tissue (EAT']","['Epicardial Adipose Tissue Volume and Attenuation', 'mean EATd', 'Mean EATv', 'median duration', 'longitudinal change in EAT volume (EATv) and density (EATd', 'body mass index, age, sex, hypertension, hyperlipidaemia, diabetes or smoking on change in EATv or EATd']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4304506', 'cui_str': 'Non-obstructive atherosclerosis of coronary artery'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]",90.0,0.0353072,"Mean EATv increased at follow-up (72 ± 33 mL to 89 ± 43 mL, p < 0.001) and mean EATd decreased (baseline -76 ± 6 HU vs. -86 ± 5 HU, p < 0.001).","[{'ForeName': 'Nitesh', 'Initials': 'N', 'LastName': 'Nerlekar', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia. nitesh.nerlekar@monash.edu.'}, {'ForeName': 'Udit', 'Initials': 'U', 'LastName': 'Thakur', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Ji Quan Samuel', 'Initials': 'JQS', 'LastName': 'Koh', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Potter', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Rahul G', 'Initials': 'RG', 'LastName': 'Muthalaly', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Hashrul N', 'Initials': 'HN', 'LastName': 'Rashid', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Cameron', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}, {'ForeName': 'Damini', 'Initials': 'D', 'LastName': 'Dey', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Dennis T L', 'Initials': 'DTL', 'LastName': 'Wong', 'Affiliation': 'Monash Cardiovascular Research Centre, Monash University and MonashHeart, Monash Health, Clayton, Victoria, Australia.'}]",Scientific reports,['10.1038/s41598-020-63135-z']
3107,32303003,"Are BMI, Self-Perceptions, Motor Competence, Engagement, and Fitness Related to Physical Activity in Physical Education Lessons?","BACKGROUND
Higher levels of actual and perceived motor competence are purported to lead to participation in physical activity (PA). Whereas considerable work has been published regarding motor and perceived competence and body mass index (BMI), much less is known about the association of these variables considering PA and engagement in physical education settings-the focus of the present study.
METHOD
In 600 children (aged 3-10 y), PA during physical education lessons, locomotor skills, object control skills, perceived competence, and BMI (study 1) were assessed. In a subsample of 149 children, PA, engagement, and health-related fitness were assessed (study 2).
RESULTS
Structural equation model showed that in study 1, locomotor skills were the strongest variable in the early years, and object control skills were the strongest later, in explained PA. The regression analysis, in study 2, showed that BMI, object control skills, and engagement were significantly associated with PA and that appropriate motor engagement was the best predictor of PA.
CONCLUSION
The authors extended previous research by providing evidence that motor competence varies across childhood in explaining participation in PA, and appropriate motor engagement plays a critical role in being active during lessons and was the strongest predictor of PA. BMI and self-perception were not significant in the models.",2020,"The regression analysis, in study 2, showed that BMI, object control skills, and engagement were significantly associated with PA and that appropriate motor engagement was the best predictor of PA.
","['600 children (aged 3-10 y), PA during physical education lessons, locomotor skills, object control skills, perceived competence, and BMI (study 1) were assessed']",[],"['BMI, object control skills, and engagement', 'BMI and self-perception', 'object control skills']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}]",600.0,0.0270548,"The regression analysis, in study 2, showed that BMI, object control skills, and engagement were significantly associated with PA and that appropriate motor engagement was the best predictor of PA.
","[{'ForeName': 'Nadia Cristina', 'Initials': 'NC', 'LastName': 'Valentini', 'Affiliation': ''}, {'ForeName': 'Glauber Carvalho', 'Initials': 'GC', 'LastName': 'Nobre', 'Affiliation': ''}, {'ForeName': 'Mariele Santayana', 'Initials': 'MS', 'LastName': 'de Souza', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Duncan', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0532']
3108,32085669,Early Modulation of Circulating MicroRNAs Levels in HER2-Positive Breast Cancer Patients Treated with Trastuzumab-Based Neoadjuvant Therapy.,"Circulating microRNA (ct-miRNAs) are able to identify patients with differential response to HER2-targeted therapy. However, their dynamics are largely unknown. We assessed 752 miRNAs from 52 NeoALTTO patients with plasma pairs prior and two weeks after trastuzumab. Increased levels of ct-miR-148a-3p and ct-miR-374a-5p were significantly associated with pathological complete response (pCR) ( p = 0.008 and 0.048, respectively). At a threshold ≥ the upper limit of the 95%CI of the mean difference, pCR resulted 45% (95%CI 24%-68%), and 44% (95%CI 22%-69%) for ct-miR-148a-3p and ct-miR-374a-5p, respectively. Notably, ct-miR-148a-3p retained its predictive value (OR 3.42, 95%CI 1.23-9.46, p = 0.018) in bivariate analysis along with estrogen receptor status. Combined information from ct-miR-148a-3p and ct-miR140-5p, which we previously reported to identify trastuzumab-responsive patients, resulted in greater predictive capability over each other, with pCR of 54% (95%CI 25%-81%) and 0% (95%CI 0%-31%) in ct-miR-148a/ct-miR-140-5p high/present and low/absent, respectively. GO and KEGG analyses showed common enriched terms between the targets of these ct-miRNAs, including cell metabolism regulation, AMPK and MAPK signaling, and HCC progression. In conclusion, early modulated ct-miR-148-3p may inform on the functional processes underlying treatment response, integrate the information from already available predictive biomarkers, and identify patients likely to respond to single agent trastuzumab-based neoadjuvant therapy.",2020,"Increased levels of ct-miR-148a-3p and ct-miR-374a-5p were significantly associated with pathological complete response (pCR) ( p = 0.008 and 0.048, respectively).",['HER2-Positive Breast Cancer Patients'],"['Trastuzumab-Based Neoadjuvant Therapy', 'trastuzumab']","['Increased levels of ct-miR-148a-3p and ct-miR-374a-5p', 'cell metabolism regulation, AMPK and MAPK signaling, and HCC progression', 'pathological complete response (pCR']","[{'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C2350345', 'cui_str': 'AMP-Activated Protein Kinase'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}]",752.0,0.0721467,"Increased levels of ct-miR-148a-3p and ct-miR-374a-5p were significantly associated with pathological complete response (pCR) ( p = 0.008 and 0.048, respectively).","[{'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Biomarker Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Appierto', 'Affiliation': 'Biomarker Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pizzamiglio', 'Affiliation': 'Bioinformatics and Biostatistics Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Silvestri', 'Affiliation': 'Biomarker Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ""Vall D'Hebron Institute of Oncology, 08035 Barcelona, Spain.""}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': ""Department of Medical Oncology, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B), 1000 Brussels, Belgium.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ulm, 89081 Ulm, Germany.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharmaceutical, 4002 Basel, Switzerland.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'de la Pena', 'Affiliation': 'SOLTI-Breast Cancer Research Group, 08035 Barcelona, Spain.'}, {'ForeName': 'Florentine S', 'Initials': 'FS', 'LastName': 'Hilbers', 'Affiliation': 'Breast International Group (BIG)-aisbl, 1000 Bruxelles, Belgium.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': ""Department of Medical Oncology, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B), 1000 Brussels, Belgium.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Gynecology and Obstetrics, Helios Klinikum Berlin-Buch, 13125 Berlin, Germany.'}, {'ForeName': 'Lajos', 'Initials': 'L', 'LastName': 'Pusztai', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, New Haven, CT 06511, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Pritchard', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, M4N 3M5 ON, Canada.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Vall D'Hebron Institute of Oncology, 08035 Barcelona, Spain.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vincent-Salomon', 'Affiliation': ""Groupe d'étude des facteurs pronostiques immunohistochimiques dans le cancer du sein, 75013 Unicancer, France.""}, {'ForeName': 'Fraser', 'Initials': 'F', 'LastName': 'Symmans', 'Affiliation': 'Department of Pathology, The UT M.D. Anderson Cancer Center, Houston, TX 77030, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Apolone', 'Affiliation': 'Scientific Directorate, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'Filippo G', 'Initials': 'FG', 'LastName': 'de Braud', 'Affiliation': 'Department of Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'Marilena V', 'Initials': 'MV', 'LastName': 'Iorio', 'Affiliation': 'Molecular Targeting Unit, Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Verderio', 'Affiliation': 'Bioinformatics and Biostatistics Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Daidone', 'Affiliation': 'Biomarker Unit, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale dei Tumori, 20100 Milan, Italy.'}]",International journal of molecular sciences,['10.3390/ijms21041386']
3109,33217131,"Fluoroscopy time analysis of a prospective, multi-centre study comparing robotic- and fluoroscopic-guided placement of percutaneous pedicle screw instrumentation for short segment minimally invasive lumbar fusion surgery.","BACKGROUND
As minimally invasive spine surgery becomes more widespread, concerns regarding radiation exposure to surgeons and patients alike have become a growing concern. Robotic guidance has been developed as a way to increase the accuracy of instrumentation while decreasing radiation burden.
METHODS
A retrospective analysis of a large, multi-centre, prospective study comparing robotic-guided (RG) to fluoroscopic-guided (FG) (Multi-centre, Partially Randomized, Controlled Trial of MIS Robotic vs. Freehand in Short Adult Degenerative Spinal Fusion Surgeries) was performed to evaluate for differences in radiation exposure between study groups.
RESULTS
RG was associated with 78.3% (p < 0.001) and 79.8% (p < 0.001) reduction in total and per screw fluoroscopy times, respectively, as compared to FG. RG was also associated with a 50.8% (p < 0.001) reduction in total operative fluoroscopy time.
CONCLUSIONS
RG was associated with significantly lower fluoroscopy times compared to FG. This suggests that utilization of robotic navigation systems may result in decreased operative radiation exposure, which is a growing concern for surgeons performing minimally invasive spine surgery.",2020,"RG was also associated with a 50.8% (p < 0.001) reduction in total operative fluoroscopy time.
","['Short Adult Degenerative Spinal Fusion Surgeries', 'short segment minimally invasive lumbar fusion surgery', 'surgeons performing minimally invasive spine surgery']","['robotic-guided (RG) to fluoroscopic-guided (FG', 'robotic- and fluoroscopic-guided placement of percutaneous pedicle screw instrumentation']","['RG', 'fluoroscopy times', 'total operative fluoroscopy time', 'total and per screw fluoroscopy times']","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]",,0.0632022,"RG was also associated with a 50.8% (p < 0.001) reduction in total operative fluoroscopy time.
","[{'ForeName': 'Aria M', 'Initials': 'AM', 'LastName': 'Jamshidi', 'Affiliation': 'Department of Neurological Surgery, University of Miami-Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Dustin H', 'Initials': 'DH', 'LastName': 'Massel', 'Affiliation': 'Department of Neurological Surgery, University of Miami-Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Jason I', 'Initials': 'JI', 'LastName': 'Liounakos', 'Affiliation': 'Department of Neurological Surgery, University of Miami-Miller School of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Zmira', 'Initials': 'Z', 'LastName': 'Silman', 'Affiliation': 'Israel Academic College, Tel Aviv University, Ramat Gan, Israel.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Good', 'Affiliation': 'Virginia Spine Institute, Reston, Virginia, USA.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Schroerlucke', 'Affiliation': 'Tabor Orthopedics, Memphis, Tennessee, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cannestra', 'Affiliation': 'Lyerly Neurosurgery, Jacksonville, Florida, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Hsu', 'Affiliation': 'Rothman Institute, Willow Grove, Pennsylvania, USA.'}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Atlantic Brain & Spine, Reston, Viginia, USA.'}, {'ForeName': 'Faissal', 'Initials': 'F', 'LastName': 'Zahrawi', 'Affiliation': 'AdventHealth Neuroscience Institute, Celebration, Florida, USA.'}, {'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Ramirez', 'Affiliation': 'Neurosurgery of Central Florida, Lake Mary, Florida, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Sweeney', 'Affiliation': 'Advanced Surgery Center of Sarasota, Sarasota, Florida, USA.'}, {'ForeName': 'Michael Y', 'Initials': 'MY', 'LastName': 'Wang', 'Affiliation': 'Department of Neurological Surgery, University of Miami-Miller School of Medicine, Miami, Florida, USA.'}]",The international journal of medical robotics + computer assisted surgery : MRCAS,['10.1002/rcs.2188']
3110,33252896,The Effect of Resourcefulness Training on Depression and Coping Styles of Patients With Coronary Heart Disease in China [RETRACTED].,"BACKGROUND
Coronary heart disease (CHD) is one of the leading causes of mortality worldwide. Previous research has demonstrated that resourcefulness interventions can help individuals identify effective coping strategies to manage their conditions, reduce the incidence of depression, and improve their quality of life. However, little is known about such interventions for people with CHD in China.
OBJECTIVE
This study aimed to investigate the effects of a resourcefulness training intervention on depression and coping style of patients with CHD in China.
METHODS
A cluster randomized controlled trial design was used. A convenience sample of 72 patients in community settings took part in the study. Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education. Participants in the control group (n = 36) received routine health education only. Three outcomes (resourcefulness, depression, and coping styles) were measured using the Resourcefulness Scale, Center for Epidemiological Studies Depression Scale, and Medical Coping Mode Questionnaire. Data were collected at baseline and post intervention, and analyzed using frequencies, percentages, means, standard deviations, independent sample t tests, and χ tests.
RESULTS
After the intervention, participants in the intervention group had significantly higher scores on resourcefulness and coping styles, and lower scores on depression than those in the control group (both Ps < .001).
CONCLUSIONS
It is suggested that a well-developed resourcefulness intervention could help patients with CHD in China and beyond to be more resourceful, improve their level of depression, and choose more effective strategies to cope with stress.",2020,"Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education.","['72 patients in community settings took part in the study', 'Patients With Coronary Heart Disease in China [RETRACTED', 'people with CHD in China', 'Participants in the intervention group (n = 36) received an', 'patients with CHD in China']","['routine health education only', '8-week intervention based on the concept of resourcefulness, plus routine health education', 'resourcefulness training intervention', 'Resourcefulness Training']","['Depression and Coping Styles', 'higher scores on resourcefulness and coping styles, and lower scores on depression', 'depression and coping style', 'Resourcefulness Scale, Center for Epidemiological Studies Depression Scale, and Medical Coping Mode Questionnaire', 'outcomes (resourcefulness, depression, and coping styles']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",72.0,0.0544968,"Participants in the intervention group (n = 36) received an 8-week intervention based on the concept of resourcefulness, plus routine health education.","[{'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Wen', 'Affiliation': ""Min Wen, BSc Master's Student, School of Nursing, University of South China, Hengyang, Hunan Province, P.R. China. Yaqin Liang, MSc Master, Medical College of Shaoguan University, Guangdong, P.R. China. Qianqian Shen, MSc Master, School of Nursing, University of South China, Hengyang, Hunan Province, P.R. China. Juping Yu, PhD Research Fellow, Faculty of Life Sciences and Education, University of South Wales, Pontypridd, United Kingdom. Pingping He, PhD Professor, School of Nursing, Institute of Cardiovascular Disease, Key Laboratory for Arteriosclerology of Hunan Province, Hunan Province Cooperative Innovation Center for Molecular Target New Drug Study, University of South China, Hengyang, Hunan Province, P.R. China. Xinping OuYang, PhD Associated Professor, Department of Physiology, Institute of Neuroscience, Hengyang Key Laboratory of Neurodegeneration and Cognitive Impairment, Hunan Province Cooperative Innovation Center for Molecular Target New Drug Research, Hengyang Medical College, University of South China, Hunan Province, P.R. China.""}, {'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Juping', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'OuYang', 'Affiliation': ''}]",The Journal of cardiovascular nursing,['10.1097/JCN.0000000000000746']
3111,33257907,Effects of Vitamin D on Left Ventricular Ejection Fraction in Patients with Systolic Heart Failure: A Double-Blind Randomized Clinical Trial.,"Background
Heart failure is a pathophysiologic state in which the cardiac output is not able to supply the body with enough oxygen and nutrients. The prevalence of heart failure has increased dramatically over the last decades. Vitamin D levels in patients with chronic heart failure are lower than healthy controls, and vitamin D deficiency has a direct relationship with mortality.
Objectives
This study aimed to evaluate the effect of vitamin D on the improvement of left ventricular ejection fraction in patients with systolic heart failure.
Methods
In this case-control clinical trial, 142 patients with chronic systolic heart failure were identified. Based on the inclusion and exclusion criteria, 114 patients were enrolled in the study and randomly divided into two groups. One group (n = 58) received 50,000 units of vitamin D capsules weekly for eight weeks, and the patients in the other group (n = 56) received a placebo. After excluding 15 patients from the placebo group and 17 patients from the intervention group during the study, according to the exclusion criteria, 41 patients were evaluated in both groups for ejection fraction changes after two months.
Results
According to the results of this research, there were no statistically significant differences in the baseline parameters between the two studied groups. The intervention group consisted of 18 female and 23 male patients with a mean age of 61.68 ± 19.8 years. Moreover, the placebo group included 21 female and 20 male patients with a mean age of 62.12 ± 18.2 years. After a 2-month follow-up, the intervention group showed statistically significant changes in ejection fraction, end-diastolic volume, and heart failure class compared to the placebo group. Also, the serum level of albumin and vitamin D in the intervention group was significantly higher than the placebo group.
Conclusions
The results of this study show that vitamin D treatment can improve the ejection fraction and functional ability of patients with vitamin D deficiency. If more comprehensive studies support this hypothesis, vitamin D deficiency assessment and correction in patients with chronic heart failure may be recommended.",2020,"According to the results of this research, there were no statistically significant differences in the baseline parameters between the two studied groups.","['patients with systolic heart failure', '114 patients were enrolled in the study and randomly divided into two groups', 'patients with chronic heart failure', 'patients with vitamin D deficiency', '18 female and 23 male patients with a mean age of 61.68 ± 19.8 years', 'group included 21 female and 20 male patients with a mean age of 62.12 ± 18.2 years', 'Patients with Systolic Heart Failure', '142 patients with chronic systolic heart failure']","['Vitamin D', 'vitamin D capsules', 'placebo', 'vitamin D']","['prevalence of heart failure', 'ejection fraction changes', 'ejection fraction, end-diastolic volume, and heart failure class', 'Vitamin D levels', 'Left Ventricular Ejection Fraction', 'serum level of albumin and vitamin D', 'ejection fraction and functional ability', 'left ventricular ejection fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1135191', 'cui_str': 'Systolic heart failure'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C1135194', 'cui_str': 'Chronic systolic heart failure'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",142.0,0.0898019,"According to the results of this research, there were no statistically significant differences in the baseline parameters between the two studied groups.","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Hassanzadeh-Makoui', 'Affiliation': 'Department of Cardiology, Mousavi Hospital, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Maziar', 'Initials': 'M', 'LastName': 'Jamei', 'Affiliation': 'Department of Cardiology, Mousavi Hospital, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Hassanzadeh-Makoui', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Khederlou', 'Affiliation': 'Resident of Cardiology, Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",International journal of endocrinology and metabolism,['10.5812/ijem.103528']
3112,33257778,Vitamins and minerals intake adequacy in hematopoietic stem cell transplant: results of a randomized controlled trial.,"Micronutrient intake among hematopoietic stem cell transplant (HSCT) recipients is poorly studied. This randomized control trial (RCT) assessed the effect of nutritional counseling on micronutrient intake post HSCT. Patients with hematological malignancies receiving HSCT were randomized at hospital discharge into an intervention group (IG) and a control group (CG) between 2016 and 2017. IG received individualized nutritional counseling in the first 3 months post HSCT while CG received general qualitative education without reinforcement. At assessment points (hospital admission, discharge, 30, 60, and 100 days post HSCT termed T4), 24-h recalls were analyzed, and micronutrient intake was compared to patients' individual needs. Results were reported as percentages of dietary reference intake. Groups (IG, n = 22 and CG, n = 24) had similar characteristics pre HSCT. Copper and α-tocopherol intake at T4 were significantly better in IG. Many B vitamins, vitamin C, Manganese, Potassium, Zinc, and vitamin K improved in IG only at T4 compared to baseline intake. Median vitamin D intake remained low in both groups with <20% of patients meeting their individual needs post HSCT. In conclusion, counseling was associated with a trend of improved micronutrient intake. Vitamin D levels remained low irrespective of counseling.",2020,Copper and α-tocopherol intake at T4 were significantly better in IG.,"['hematopoietic stem cell transplant (HSCT) recipients', 'hematopoietic stem cell transplant', 'Patients with hematological malignancies receiving HSCT']","['nutritional counseling', 'individualized nutritional counseling', 'Vitamins and minerals intake adequacy']","['Vitamin D levels', 'vitamin C, Manganese, Potassium, Zinc, and vitamin K', 'dietary reference intake', 'Copper and α-tocopherol intake', 'Median vitamin D intake']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0518042', 'cui_str': 'Mineral intake'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0024706', 'cui_str': 'Manganese'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C2985508', 'cui_str': 'Dietary Reference Intake'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0564438', 'cui_str': 'Vitamin E intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}]",,0.227146,Copper and α-tocopherol intake at T4 were significantly better in IG.,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Jabbour', 'Affiliation': 'Department of Clinical Nutrition, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Batoul', 'Initials': 'B', 'LastName': 'Manana', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Zahreddine', 'Affiliation': 'Bone Marrow Transplantation Program, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Al-Shaar', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bazarbachi', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': ""Département d'hématologie, Programme de transplantation et de thérapie Cellulaire, Institut Paoli-Calmettes, Marseille, France.""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'El-Cheikh', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. je46@aub.edu.lb.'}]",Bone marrow transplantation,['10.1038/s41409-020-01154-0']
3113,33257672,Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer.,"Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (FLOT regimen) has shown promising results in terms of pathological response and survival rate in patients with locally advanced resectable gastric cancer (LAGC). However, tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (SOX regimen) is the preferred chemotherapy regimen in Eastern countries. Here, we conduct an open label, two-arm, phase II randomized interventional clinical trial (Dragon III; ClinicalTrials.gov: NCT03636893) to evaluate the safety and efficacy of both regimens. Patients with LAGC are randomly assigned to receive either 4 cycles of the neoadjuvant FLOT regimen (40 patients) or 3 cycles of the SOX regimen (34 patients) before gastrectomy. The primary endpoint is the comparison of complete (TRG1a) or subtotal (TRG1b) tumor regression grading in the primary tumor. There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups. No significant differences in the proportion of tumor regression grading between the FLOT group and the SOX group are found. Complete or subtotal TRG is 20.0% in the FLOT group versus 32.4% in the SOX group. Therefore, our study does not find statistically significant differences between neoadjuvant FLOT and SOX regimens for the primary outcomes reported here in locally advanced gastric cancer.",2020,There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups.,"['Patients with LAGC', 'patients with locally advanced gastric cancer', 'Eastern countries', 'patients with locally advanced resectable gastric cancer (LAGC']","['Neoadjuvant FLOT', 'neoadjuvant FLOT regimen (40 patients) or 3 cycles of the SOX regimen (34 patients) before gastrectomy', 'Neoadjuvant chemotherapy with docetaxel, oxaliplatin, fluorouracil, and leucovorin (FLOT regimen', 'FLOT', 'tegafur gimeracil oteracil potassium capsule (S-1) plus oxaliplatin (SOX regimen']","['safety and efficacy', 'locally advanced gastric cancer', 'Complete or subtotal TRG', 'pathological response and survival rate', 'proportion of tumor regression grading', 'adverse effects or postoperative morbidity and mortality', 'comparison of complete (TRG1a) or subtotal (TRG1b) tumor regression grading in the primary tumor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C3851369', 'cui_str': 'tegafur-gimeracil-oteracil'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0087051', 'cui_str': 'T-Cell Receptor gamma-Chain'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.0699909,There are no significant differences in adverse effects or postoperative morbidity and mortality between the two groups.,"[{'ForeName': 'Birendra Kumar', 'Initials': 'BK', 'LastName': 'Sah', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China. rjsurgeon@hotmail.com.'}, {'ForeName': 'Benyan', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Pathology Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Clinical Research Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Pathology Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': 'Department of Medical Oncology Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China.'}, {'ForeName': 'Zhenglun', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China. lc10897@rjh.com.cn.'}, {'ForeName': 'Bingya', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China.'}, {'ForeName': 'Zhenggang', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of General Surgery, Gastrointestinal Surgery Unit, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Gastric Neoplasms, Shanghai Institute of Digestive Surgery, Shanghai, China. zzg@rjh.com.cn.'}]",Nature communications,['10.1038/s41467-020-19965-6']
3114,33257661,A randomised clinical trial of methotrexate points to possible efficacy and adaptive immune dysfunction in psychosis.,"NMDA autoantibody encephalitis presenting as schizophrenia suggests the possible role of adaptive cell-mediated immunity in idiopathic schizophrenia. However, to our knowledge there have been no trials of the immune-suppressant methotrexate in schizophrenia. We tested if low-dose methotrexate as used in the treatment of systemic autoimmune disorders would be tolerable and effective in people with schizophrenia in a feasibility study. Ninety-two participants within 5 years of schizophrenia diagnosis were recruited from inpatient and outpatient facilities in Karachi, Pakistan. They were randomised to receive once weekly 10-mg oral methotrexate (n = 45) or matching placebo (n = 47) both with daily 5-mg folic acid, in addition to treatment as usual for 12 weeks. There were eight dropouts per group. Side effects were non-significantly more common in those on methotrexate and were not severe. One person developed leukopenia. Positive symptom scores improved more in those receiving methotrexate than placebo (β = -2.5; [95% CI -4.7 to -0.4]), whereas negative symptoms were unaffected by treatment (β = -0.39; [95% CI -2.01 to 1.23]). There were no immune biomarkers but methotrexate did not affect group mean leucocyte counts or C-reactive protein. We conclude that further studies are feasible but should be focussed on subgroups identified by advances in neuroimmune profiling. Methotrexate is thought to work in autoimmune disorders by resetting systemic regulatory T-cell control of immune signalling; we show that a similar action in the CNS would account for otherwise puzzling features of the immuno-pathogenesis of schizophrenia.",2020,Positive symptom scores improved more in those receiving methotrexate than placebo (β = -2.5;,"['people with schizophrenia', 'psychosis', 'Ninety-two participants within 5 years of schizophrenia diagnosis were recruited from inpatient and outpatient facilities in Karachi, Pakistan']","['methotrexate', 'Methotrexate', 'methotrexate (n\u2009=\u200945) or matching placebo (n\u2009=\u200947) both with daily 5-mg folic acid', 'placebo']","['mean leucocyte counts or C-reactive protein', 'Side effects', 'Positive symptom scores', 'leukopenia', 'negative symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",92.0,0.19869,Positive symptom scores improved more in those receiving methotrexate than placebo (β = -2.5;,"[{'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Chaudhry', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Neuroscience and Experimental Psychology, School of Biological Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}, {'ForeName': 'M O', 'Initials': 'MO', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada. omair.husain@camh.ca.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Khoso', 'Affiliation': 'Pakistan Institute of Living and Learning, Karachi, Pakistan.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Husain', 'Affiliation': 'Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'M H', 'Initials': 'MH', 'LastName': 'Buch', 'Affiliation': 'National Institute of Health Research Leeds Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kiran', 'Affiliation': 'Pakistan Institute of Living and Learning, Karachi, Pakistan.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': 'School of Data Science, Fundan University, Shanghai, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Stats Consultancy, Amersham, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Qurashi', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, School of Biological Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ur Rahman', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Baig', 'Affiliation': 'Baqai University, Karachi, Pakistan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kazmi', 'Affiliation': 'Karwan e Hayat, Karachi, Pakistan.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Corsi-Zuelli', 'Affiliation': 'Division of Psychiatry, Department of Neuroscience and Behaviour, Ribeirão Preto Medical School, University of São Paulo (FMRP-USP), São Paulo, São Paulo, 14048-900, Brazil.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Haddad', 'Affiliation': 'Hamad Medical Corporation, Doha, Qatar.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Deakin', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Neuroscience and Experimental Psychology, School of Biological Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Husain', 'Affiliation': 'Faculty of Biology, Medicine and Health, Division of Psychology and Mental Health, School of Biological Sciences, University of Manchester, Manchester Academic Health Science Centre, Manchester, M13 9PT, UK.'}]",Translational psychiatry,['10.1038/s41398-020-01095-8']
3115,33257485,Feasibility of reporting results of large randomised controlled trials to participants: experience from the Fluoxetine Or Control Under Supervision (FOCUS) trial.,"OBJECTIVES
Informing research participants of the results of studies in which they took part is viewed as an ethical imperative. However, there is little guidance in the literature about how to do this. The Fluoxetine Or Control Under Supervision trial randomised 3127 patients with a recent acute stroke to 6 months of fluoxetine or placebo and was published in the Lancet on 5 December 2018. The trial team decided to inform the participants of the results at exactly the same time as the Lancet publication, and also whether they had been allocated fluoxetine or placebo. In this report, we describe how we informed participants of the results.
DESIGN
In the 6-month and 12-month follow-up questionnaires, we invited participants to provide an email address if they wished to be informed of the results of the trial. We re-opened our trial telephone helpline between 5 December 2018 and 31 March 2019.
SETTING
UK stroke services.
PARTICIPANTS
3127 participants were randomised. 2847 returned 6-month follow-up forms and 2703 returned 12-month follow-up forms; the remaining participants had died (380), withdrawn consent or did not respond.
RESULTS
Of those returning follow-up questionnaires, a total of 1845 email addresses were provided and a further 50 people requested results to be sent by post. Results were sent to all email and postal addresses provided; 309 emails were returned unrecognised. Seventeen people replied, of whom three called the helpline and the rest responded by email.
CONCLUSION
It is feasible to disseminate results of large trials to research participants, though only around 60% of those randomised wanted to receive the results. The system we developed was efficient and required very little resource, and could be replicated by trialists in the future.
TRIAL REGISTRATION NUMBER
ISRCTN83290762; Post-results.",2020,The Fluoxetine Or Control,"['UK stroke services', '3127 participants were randomised', 'Seventeen people replied, of whom three called the helpline and the rest responded by email', '3127 patients with a recent acute stroke to 6\u2009months of', '5 December 2018 and 31 March 2019', 'and was published in the Lancet on 5 December 2018']","['fluoxetine or placebo', 'Fluoxetine Or Control', 'withdrawn consent or did not respond']",[],"[{'cui': 'C0587667', 'cui_str': 'Stroke service'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0777169', 'cui_str': 'Lancet'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]",[],3127.0,0.111743,The Fluoxetine Or Control,"[{'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Mead', 'Affiliation': 'Geriatric Medicine, University of Edinburgh, Edinburgh, UK gillian.e.mead@ed.ac.uk.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dennis', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2020-040492']
3116,33257497,New composite endpoint in early diffuse cutaneous systemic sclerosis: revisiting the provisional American College of Rheumatology Composite Response Index in Systemic Sclerosis.,"OBJECTIVES
American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS) is a composite endpoint to assess the likelihood of improvement in diffuse systemic sclerosis. ACR-CRISS is a weighted score and includes five core set measures: modified Rodnan skin score, FVC% predicted, health assessment questionnaire-disability index, and patient and clinician global assessments.
METHODS
We analysed core set measures from 354 participants who participated in three placebo-controlled trials. We generated 10 development datasets, randomly selected from 2/3 of the participants, stratified by study and treatment group. The remaining participants (1/3 of the participants) formed the validation sets. Risk differences (RDs) between active and placebo treatments were calculated by averaging over the replicate datasets; bootstrap 95% CIs for the RDs to estimate the magnitude of treatment effects.
RESULTS
In the development sets (n=237), the proportion of participants in the active group had statistically higher improvement in >1 of 5 core set measures versus the placebo group. For example, the proportion who improved by ≥20% in ≥3 core set measures was 49.4% in the active versus338.9% in the placebo; RD: 10.5%, 95% CI4.9 % to 16.1%. In the validation sets (n=117), the proportion who improved by ≥20% in ≥3 core set measures was 50.3% in the active versus35.63% in the placebo (RD:114.8%, 95% CI 3.1% to225.7%). Similar trends were seen with larger percentage cut-offs.
CONCLUSION
Revised CRISS, as assessed by the proportion of participants who improved by a certain percentage in ≥3 of 5 core set measures, is a potential new composite outcome measure.",2020,"In the development sets (n=237), the proportion of participants in the active group had statistically higher improvement in >1 of 5 core set measures versus the placebo group.","['354 participants who participated in three placebo-controlled trials', 'early diffuse cutaneous systemic sclerosis', 'American College of Rheumatology Composite Response Index in Systemic Sclerosis (ACR-CRISS']",['placebo'],"['modified Rodnan skin score, FVC% predicted, health assessment questionnaire-disability index, and patient and clinician global assessments']","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1258104', 'cui_str': 'Progressive systemic sclerosis'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4728203', 'cui_str': 'Modified Rodnan skin score'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",354.0,0.173049,"In the development sets (n=237), the proportion of participants in the active group had statistically higher improvement in >1 of 5 core set measures versus the placebo group.","[{'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Khanna', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA khannad@med.umich.edu.'}, {'ForeName': 'Suiyuan', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Celia J F', 'Initials': 'CJF', 'LastName': 'Lin', 'Affiliation': 'Genentech Inc, South San Francisco, California, USA.'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, Michigan, USA.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-219100']
3117,33257486,Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial.,"INTRODUCTION
Real-time continuous glucose monitoring (rt-CGM) informs users about current interstitial glucose levels and allows early detection of glycaemic excursions and timely adaptation by behavioural change or pharmacological intervention. Randomised controlled studies adequately powered to evaluate the impact of long-term application of rt-CGM systems on the reduction of adverse obstetric outcomes in women with gestational diabetes (GDM) are missing. We aim to assess differences in the proportion of large for gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome). Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia are secondary outcomes. A comparison of glucose metabolism and quality of life during and after pregnancy completes the scope of this study.
METHODS AND ANALYSIS
Open-label multicentre randomised controlled trial with two parallel groups including 372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG). Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days. The third visit will be scheduled 8-10 days later and then every 2 weeks. At every visit, glucose measurements will be evaluated and all patients will be treated according to the standard care. The control group will receive a blinded CGM for 10 days between the second and third visit and between week 36+0 and 38+6. Cord blood will be sampled immediately after delivery. 48 hours after delivery neonatal biometry and maternal glycosylated haemoglobin A1c (HbA1c) will be assessed, and between weeks 8 and 16 after delivery all patients receive a re-examination of glucose metabolism including blinded CGM for 8-10 days.
ETHICS AND DISSEMINATION
This study received ethical approval from the main ethic committee in Vienna. Data will be presented at international conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT03981328; Pre-results.",2020,Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days.,"['patients with gestational diabetes mellitus', '372 female patients with a recent diagnosis of GDM (between 24+0 until 31+6 weeks of gestation): 186 with rt-CGM (Dexcom G6) and 186 with self-monitored blood glucose (SMBG', 'Women with GDM', 'gestational age newborns in women using rt-CGM as compared with women with self-monitored blood glucose (primary outcome', 'women with gestational diabetes (GDM']","['Real-time continuous glucose monitoring (rt-CGM', 'rt-CGM or control (SMBG', 'blinded CGM', 'rt-CGM systems', 'real-time continuous glucose monitoring']","['glucose metabolism and quality of life', 'adverse obstetric outcomes', 'maternal glycosylated haemoglobin A1c (HbA1c', 'Rates of neonatal hypoglycaemia, caesarean section and shoulder dystocia', 'glycaemic control and pregnancy outcome']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005803', 'cui_str': 'Self-monitoring of blood glucose'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0158986', 'cui_str': 'Neonatal hypoglycemia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0269825', 'cui_str': 'Shoulder girdle dystocia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",372.0,0.157518,Women with GDM will be consecutively recruited and randomised to rt-CGM or control (SMBG) group after a run-in period of 6-8 days.,"[{'ForeName': 'Evelyn Annegret', 'Initials': 'EA', 'LastName': 'Huhn', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Linder', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eppel', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Weißhaupt', 'Affiliation': 'Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klapp', 'Affiliation': 'Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Schellong', 'Affiliation': 'Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Henrich', 'Affiliation': 'Clinic of Obstetrics, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Gülen', 'Initials': 'G', 'LastName': 'Yerlikaya-Schatten', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Rosicky', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Husslein', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Chalubinski', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mittlböck', 'Affiliation': 'Center of Medical Statistics, Informatics, and Intelligent Systems, Section for Clinical Biometrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rust', 'Affiliation': 'Department of Nutritional Sciences, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hoesli', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Winzeler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Jendle', 'Affiliation': 'Institution of Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Fehm', 'Affiliation': 'Department of Obstetrics and Gynaecology, Medical Faculty, Heinrich-Heine University Düsseldorf, Dusseldorf, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Vomhof', 'Affiliation': 'Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Gregory Gordon', 'Initials': 'GG', 'LastName': 'Greiner', 'Affiliation': 'Institute of Health Services Research and Health Economics, Centre for Health and Society, Faculty of Medicine, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Szendrödi', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Roden', 'Affiliation': 'German Center for Diabetes Research, München-Neuherberg, Oberschleißheim, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, Institute of Neuroscience, National Research Council, Padova, Italy.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Göbl', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria christian.goebl@meduniwien.ac.at.'}]",BMJ open,['10.1136/bmjopen-2020-040498']
3118,33257457,Influence of polypharmacy on patients with heart failure with preserved ejection fraction: a retrospective analysis on adverse outcomes in the TOPCAT trial.,"BACKGROUND
Polypharmacy is common in heart failure (HF), whereas its effect on adverse outcomes in patients with HF with preserved ejection fraction (HFpEF) is unclear.
AIM
To evaluate the prevalence, prognostic impacts, and predictors of polypharmacy in HFpEF patients.
DESIGN AND SETTING
A retrospective analysis performed on patients in the Americas region (including the US, Canada, Argentina, and Brazil) with symptomatic HF and a left ventricular ejection fraction ≥45% in the TOPCAT (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist) trial, an international, randomised, double-blind, placebo-controlled study conducted during 2006-2013 in six countries.
METHOD
Patients were categorised into four groups: controls (<5 medications), polypharmacy (5-9 medications), hyperpolypharmacy, (10- 14 medications), and super hyperpolypharmacy (≥15 medications). The outcomes and predictors in all groups were assessed.
RESULTS
Of 1761 participants, the median age was 72 years; 37.5% were polypharmacy, 35.9% were hyperpolypharmacy, and 19.6% were super hyperpolypharmacy, leaving 7.0% having a low medication burden. In multivariable regression models, three experimental groups with a high medication burden were all associated with a reduction in all-cause death, but increased risks of HF hospitalisation and all-cause hospitalisation. Furthermore, several comorbidities (dyslipidemia, thyroid diseases, diabetes mellitus, and chronic obstructive pulmonary disease), a history of angina pectoris, diastolic blood pressure <80 mmHg, and worse heart function (the New York Heart Association functional classification level III and IV) at baseline were independently associated with a high medication burden among patients with HFpEF.
CONCLUSION
A high prevalence of high medication burden at baseline was reported in patients with HFpEF. The high medication burden might increase the risk of hospital readmission, but not the mortality.",2020,"In multivariable regression models, three experimental groups with a high medication burden were all associated with a reduction in all-cause death, but increased risks of HF hospitalisation and all-cause hospitalisation.","['patients with HF with preserved ejection fraction (HFpEF', 'HFpEF patients', '1761 participants', 'patients in the Americas region (including the US, Canada, Argentina, and Brazil) with symptomatic HF and a left ventricular ejection fraction', 'patients with heart failure with preserved ejection fraction', 'Patients were categorised into four groups: controls (<5 medications), polypharmacy (5-9 medications), hyperpolypharmacy, (10- 14 medications), and super hyperpolypharmacy (≥15 medications', 'patients with HFpEF', '2006-2013 in six countries']","['polypharmacy', 'TOPCAT', 'placebo']","['risk of hospital readmission', 'several comorbidities (dyslipidemia, thyroid diseases, diabetes mellitus, and chronic obstructive pulmonary disease', 'risks of HF hospitalisation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0766551,"In multivariable regression models, three experimental groups with a high medication burden were all associated with a reduction in all-cause death, but increased risks of HF hospitalisation and all-cause hospitalisation.","[{'ForeName': 'Yuzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Wengen', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}, {'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Fangfei', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Dexi', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Jiangui', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'NHC Key Laboratory of Assisted Circulation (Sun Yat-Sen University), Guangzhou 510080, PR China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'National-Guangdong Joint Engineering Laboratory for Diagnosis and Treatment of Vascular Diseases, Guangzhou, PR China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, PR China.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp21X714245']
3119,33257417,Planning prompts to promote uptake of HIV services among men: a randomised trial in rural Uganda.,"INTRODUCTION
Interventions informed by behavioural economics, such as planning prompts, have the potential to increase HIV testing at minimal or no cost. Planning prompts have not been previously evaluated for HIV testing uptake. We conducted a randomised clinical trial to evaluate the effectiveness of low-cost planning prompts to promote HIV testing among men.
METHODS
We randomised adult men in rural Ugandan parishes to receive a calendar planning prompt that gave them the opportunity to make a plan to get tested for HIV at health campaigns held in their communities. Participants received either a calendar showing the dates when the community health campaign would be held (control group) or a calendar showing the dates and prompting them to select a date and time when they planned to attend (planning prompt group). Participants were not required to select a date and time or to share their selection with study staff. The primary outcome was HIV testing uptake at the community health campaign.
RESULTS
Among 2362 participants, 1796 (76%) participants tested for HIV. Men who received a planning prompt were 2.2 percentage points more likely to test than the control group, although the difference was not statistically significant (77.1% vs 74.9%; 95% CI -1.2 to 5.7 percentage points, p=0.20). The planning prompt was more effective among men enrolled ≤40 days before the campaigns (3.6 percentage-point increase in testing; 95% CI -2.9 to 10.1, p=0.27) than among men enrolled >40 days before the campaigns (1.8 percentage-point increase; 95% CI -2.3 to 5.8, p=0.39), although the effects within the subgroups were not significant.
CONCLUSION
These findings suggest that planning prompts may be an effective behavioural intervention to promote HIV testing at minimal or no cost. Large-scale studies should further assess the impact and cost-effectiveness of such interventions.",2020,"The planning prompt was more effective among men enrolled ≤40 days before the campaigns (3.6 percentage-point increase in testing; 95% CI -2.9 to 10.1, p=0.27) than among men enrolled >40 days before the campaigns (1.8 percentage-point increase; 95% CI -2.3 to 5.8, p=0.39), although the effects within the subgroups were not significant.
","['men', '2362 participants, 1796 (76%) participants tested for HIV', 'adult men in rural Ugandan parishes']",['low-cost planning'],['HIV testing uptake at the community health campaign'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]","[{'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}]",2362.0,0.0652361,"The planning prompt was more effective among men enrolled ≤40 days before the campaigns (3.6 percentage-point increase in testing; 95% CI -2.9 to 10.1, p=0.27) than among men enrolled >40 days before the campaigns (1.8 percentage-point increase; 95% CI -2.3 to 5.8, p=0.39), although the effects within the subgroups were not significant.
","[{'ForeName': 'Nolan M', 'Initials': 'NM', 'LastName': 'Kavanagh', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elisabeth M', 'Initials': 'EM', 'LastName': 'Schaffer', 'Affiliation': 'Data Science to Patient Value, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ndyabakira', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Central Region, Uganda.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Marson', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Central Region, Uganda.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Central Region, Uganda.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'Division of HIV, Infectious Diseases and Global Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA hthirumu@pennmedicine.upenn.edu.'}]",BMJ global health,['10.1136/bmjgh-2020-003390']
3120,33257343,Hyoscine butylbromide versus acetaminophen for nonspecific colicky abdominal pain in children: a randomized controlled trial.,"BACKGROUND
Less than two-thirds of children with abdominal pain in the emergency department receive analgesia. We sought to determine whether hyoscine butylbromide was superior to acetaminophen for children with nonspecific colicky abdominal pain.
METHODS
We randomly allocated children aged 8-17 years with nonspecific colicky abdominal pain who presented to the pediatric emergency department of London Health Sciences Centre, London, Ontario to receive hyoscine butylbromide, 10 mg given orally, or acetaminophen, 15 mg/kg given orally (maximum 975 mg). We considered the minimal clinically important difference for the primary outcome (self-reported pain at 80 min) to be 13 mm on a 100 mm visual analogue scale. Secondary outcomes included administration of rescue analgesia, adverse effects and pain score less than 30 mm at 80 minutes.
RESULTS
A total of 236 participants (120 in the hyoscine butylbromide group and 116 in the acetaminophen group) were included in the trial. The mean visual analogue scale scores at 80 minutes were 29 mm (standard deviation [SD] 26 mm) and 30 mm (SD 29 mm) with hyoscine butylbromide and acetaminophen, respectively (adjusted difference 1, 95% confidence interval -7 to 7). Rescue analgesia was administered to 4 participants (3.3%) in the hyoscine butylbromide group and 1 participant (0.9%) in the acetaminophen groups ( p = 0.2). We found no significant differences in rates of adverse effects between hyoscine butylbromide (32/116 [27.6%]) and acetaminophen (28/115 [24.3]) ( p = 0.5); no serious adverse effects were observed. The proportion with a pain score less than 30 mm at 80 minutes was 66 (55.0%) with hyoscine butylbromide and 63 (54.3%) with acetaminophen ( p = 0.9).
INTERPRETATION
Hyoscine butylbromide was not superior to acetaminophen in this setting. Both agents were associated with clinically important pain reduction, and either can be considered for children presenting to the emergency department with nonspecific colicky abdominal pain. Trial registration: Clinicaltrials.gov, no. NCT02582307.",2020,Rescue analgesia was administered to 4 participants (3.3%) in the hyoscine butylbromide group and 1 participant (0.9%) in the acetaminophen groups ( p = 0.2).,"['We randomly allocated children aged 8-17 years with nonspecific colicky abdominal pain who presented to the pediatric emergency department of London Health Sciences Centre, London, Ontario to receive', 'children', 'children with abdominal pain in the emergency department receive analgesia', 'children with nonspecific colicky abdominal pain', 'children presenting to the emergency department with nonspecific colicky abdominal pain', '236 participants (120 in the hyoscine butylbromide group and 116 in the acetaminophen group) were included in the trial']","['acetaminophen', 'Hyoscine butylbromide versus acetaminophen', 'hyoscine butylbromide', 'hyoscine butylbromide, 10 mg given orally, or acetaminophen']","['rates of adverse effects', 'administration of rescue analgesia, adverse effects and pain score less', 'serious adverse effects', 'Rescue analgesia', 'proportion with a pain score', 'mean visual analogue scale scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0232488', 'cui_str': 'Abdominal colic'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0006519', 'cui_str': 'Scopolamine butylbromide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0006519', 'cui_str': 'Scopolamine butylbromide'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",236.0,0.672325,Rescue analgesia was administered to 4 participants (3.3%) in the hyoscine butylbromide group and 1 participant (0.9%) in the acetaminophen groups ( p = 0.2).,"[{'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta. naveen.poonai@lhsc.on.ca.""}, {'ForeName': 'Kriti', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Kamary', 'Initials': 'K', 'LastName': 'Coriolano', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thompson', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Shaily', 'Initials': 'S', 'LastName': 'Brahmbhatt', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dzongowski', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Stevens', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Sharlene', 'Initials': 'S', 'LastName': 'Elsie', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Dhandapani', 'Initials': 'D', 'LastName': 'Ashok', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Joubert', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Andreana', 'Initials': 'A', 'LastName': 'Bütter', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': ""Division of Emergency Medicine (Poonai, Kumar, Coriolano, Brahmbhatt, Dzongowski, Stevens, Gupta, Miller, Elsie, Joubert, Lim), Department of Paediatrics, and Departments of Internal Medicine (Poonai, Elsie) and Epidemiology and Biostatistics (Poonai, Elsie), Schulich School of Medicine and Dentistry, Western University; Children's Health Research Institute (Poonai, Miller, Lim), London Health Sciences Centre, London, Ont.; Departments of Pediatrics (Thompson) and Emergency Medicine (Thompson), Cumming School of Medicine, and Alberta Children's Hospital Research Institute (Thompson), University of Calgary, Calgary, Alta.; Division of Gastroenterology (Ashok), Department of Paediatrics, Schulich School of Medicine and Dentistry, Western University; Division of Paediatric Surgery (Bütter), Department of Surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont.; Department of Pediatrics (Ali), Faculty of Medicine & Dentistry, and Women and Children's Health Research Institute (Ali), University of Alberta, Edmonton, Alta.""}]",CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne,['10.1503/cmaj.201055']
3121,33257297,Long-Term Effects of Mental Training on Manual and Cognitive Skills in Surgical Education - A Prospective Study.,"OBJECTIVES
Limited training opportunities and expanding requirements are challenging surgical education, calling for alternative training methods like simulation or mental training. The aim of this study is to evaluate short- and long-term effects of a structured mental training on surgical performance.
DESIGN
Medical students without laparoscopic experience were randomly assigned to 3 groups: (1) control (2) video training, and (3) video plus mental training performing 2 E-BLUS (European Training in Basic Laparoscopic Urological Skills) exercises, ""peg transfer"" (PT) and ""cutting a circle"" (CC). Group 3 performed a structured mental training course (identification of procedural key steps, relaxation, mental vocalization, and imaging). Longitudinal assessment including binominal checklists, global rating scales (GRS), procedural times, and Test of Performance Strategies (TOPS) were performed at baseline, day 2, 14, and after 16 months. Statistical analysis included ANOVA and general linear models with repeated measures.
SETTING
The study was conducted in ""Olympus Training and Education Center Hamburg West"" and ""Endo Club Academy"" at the University Medical Center Hamburg-Eppendorf.
PARTICIPANTS
Participants were eligible if they were medical students with no experience in laparoscopy. 24 participants were recruited and finished the study.
RESULTS
The mental training group maintained significantly better GRS scores at 16 months for PT (mean score 24.6 [95% CI: 21-28.25]) and CC (mean score 22.5 [18.4-26.6]) (both p < 0.01) and performed faster in the latter (261 seconds [Std. Dev 116] vs. 427 seconds [SD 132] vs. 368 seconds [SD 78]) compared to the other groups (p = 0.004). Longitudinally, mental training had a significant effect on TOPS scores and procedural times (p < 0.001 and p = 0.005, respectively).
CONCLUSION
In addition to short time efficacy, our study is the first to ascertain a positive long-term effect of mental training on manual and cognitive skills and might be a useful and cost-effective tool in surgical education.",2020,"Longitudinally, mental training had a significant effect on TOPS scores and procedural times (p < 0.001 and p = 0.005, respectively).
","['Medical students without laparoscopic experience', '24 participants were recruited and finished the study', 'The study was conducted in ""Olympus Training and Education Center Hamburg West"" and ""Endo Club Academy"" at the University Medical Center Hamburg-Eppendorf', 'Participants were eligible if they were medical students with no experience in laparoscopy']","['structured mental training', 'structured mental training course (identification of procedural key steps, relaxation, mental vocalization, and imaging', 'European Training in Basic Laparoscopic Urological Skills) exercises, ""peg transfer"" (PT) and ""cutting a circle"" (CC', 'Mental Training', 'mental training', 'control (2) video training, and (3) video plus mental training performing 2 E-BLUS']","['TOPS scores and procedural times', 'GRS scores', 'binominal checklists, global rating scales (GRS), procedural times, and Test of Performance Strategies', 'Manual and Cognitive Skills']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0042932', 'cui_str': 'Singing, Animal'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]",24.0,0.0230536,"Longitudinally, mental training had a significant effect on TOPS scores and procedural times (p < 0.001 and p = 0.005, respectively).
","[{'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Kaulfuss', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department of Urology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Kluth', 'Affiliation': 'Department of Urology, Goethe University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Marks', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grange', 'Affiliation': 'Johnson & Johnson, Norderstedt, Germany.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Fisch', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Felix K H', 'Initials': 'FKH', 'LastName': 'Chun', 'Affiliation': 'Department of Urology, Goethe University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Meyer', 'Affiliation': 'Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: christian.p.meyer@googlemail.com.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.11.005']
3122,33257037,"Negative pressure wound therapy for prevention of surgical site infection in patients at high risk after clean-contaminated major pancreatic resections: A single-center, phase 3, randomized clinical trial.","BACKGROUND
Surgical site infections are an important burden of pancreatic surgery, prolonging hospitalization and delaying adjuvant treatment. The aim of this study was to compare negative pressure wound therapy with standard sterile dressing in terms of the prevention of non-organ-space surgical site infection (superficial and deep surgical site infection) in the high-risk setting.
METHODS
The trial was conducted at the University of Verona Hospital Trust, Verona, Italy, from July 25, 2018, through October 10, 2019, among adults undergoing surgery for periampullary neoplasms. Only patients at high-risk for surgical site infection based on body mass index, diabetes, steroids, neoadjuvant therapy, American Society of Anesthesiologists score, Charlson comorbidity index, duration of surgery, and blood loss were included and randomized.
RESULTS
A total of 351 patients were screened, 100 met the inclusion criteria and were 1:1 allocated in the 2 arms. The difference in terms of non-organ-space surgical site infection comparing negative pressure wound therapy with standard sterile dressing was not significant (10.9 vs 12.2%, risk ratio [RR] 1.144, confidence interval [CI] 95% 0.324-4.040, P = 1.000). Hematomas (4.3 vs 2%, RR 1.565, CI 95% 0.312-7.848, P = .609) and organ-space infections (46.7 vs 43.8%, RR 1.059, CI 95% 0.711-1.576, P = .836) were similar. Negative pressure wound therapy prevented the development of seromas (0 vs 12.2%, RR 0.483, CI 95% 0.390-0.599, P = .027). The aesthetic result assessed on postoperative day 7 was better in the negative pressure wound therapy group (visual analogue scale, 8 vs 7, P = .029; Stony Brook Scar Evaluation Scale, 3.2 vs 2.5, P = .009), but it was no more evident on postoperative day 30 after a total number of 23 dropouts.
CONCLUSION
Compared with standard sterile dressing, negative pressure wound therapy is not associated with an improved rate of non-organ-space surgical site infection after surgery for periampullary neoplasms in patients at high risk for surgical site infection. Additional studies will help identify the population that could benefit most from this intervention.",2020,"Compared with standard sterile dressing, negative pressure wound therapy is not associated with an improved rate of non-organ-space surgical site infection after surgery for periampullary neoplasms in patients at high risk for surgical site infection.","['351 patients were screened, 100 met the inclusion criteria and were 1:1 allocated in the 2 arms', 'Only patients at high-risk for surgical site infection based on body mass index, diabetes, steroids, neoadjuvant therapy, American Society of Anesthesiologists score, Charlson comorbidity index, duration of surgery, and blood loss were included and randomized', 'patients at high risk after clean-contaminated major pancreatic resections', 'University of Verona Hospital Trust, Verona, Italy, from July 25, 2018, through October 10, 2019, among adults undergoing surgery for periampullary neoplasms']","['standard sterile dressing, negative pressure wound therapy', 'standard sterile dressing', 'Negative pressure wound therapy']","['organ-space infections', 'Hematomas', 'Stony Brook Scar Evaluation Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0205279', 'cui_str': 'Contaminated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",351.0,0.146559,"Compared with standard sterile dressing, negative pressure wound therapy is not associated with an improved rate of non-organ-space surgical site infection after surgery for periampullary neoplasms in patients at high risk for surgical site infection.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Andrianello', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Landoni', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bortolato', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Iudici', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Tuveri', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pea', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'De Pastena', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Malleo', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Bonamini', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Gessica', 'Initials': 'G', 'LastName': 'Manzini', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Bassi', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy. Electronic address: claudio.bassi@univr.it.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Salvia', 'Affiliation': 'Department of General and Pancreatic Surgery- The Pancreas Institute, University of Verona Hospital Trust, Verona, Italy.'}]",Surgery,['10.1016/j.surg.2020.10.029']
3123,33257013,Adequate statistical analyses and inferences of Randomized Clinical Trial.,,2020,,[],[],[],[],[],[],,0.0608775,,"[{'ForeName': 'Andrea Batista de Sousa', 'Initials': 'ABS', 'LastName': 'Canheta', 'Affiliation': 'Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias (UFG), Brazil; Faculty of Education, Federal University of Goias (UFG), Brazil.'}, {'ForeName': 'Annelisa Silva E Alves de Carvalho', 'Initials': 'ASEAC', 'LastName': 'Santos', 'Affiliation': 'United Faculty of Campinas (Unicamps/Goias), Brazil.'}, {'ForeName': 'Jacqueline Danesio', 'Initials': 'JD', 'LastName': 'de Souza', 'Affiliation': 'Course of Nutrition, University of North Parana (UNOPAR - Londrina/PR), Brazil.'}, {'ForeName': 'Erika Aparecida', 'Initials': 'EA', 'LastName': 'Silveira', 'Affiliation': 'Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Goias (UFG), Brazil. Electronic address: erikasil@terra.com.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.11.016']
3124,33256887,Factors influencing engagement and dietary behaviour change of mothers and their children in a blog-delivered healthy eating intervention: a process evaluation of a randomized controlled trial.,"OBJECTIVE
A randomized controlled trial found no evidence of an impact of a blog written by a registered dietitian (RD) on vegetables and fruit and milk and alternatives (e.g. soy-based beverages, yogurt, cheese) consumption - two food groups included in the 2007 version of the Canadian Food Guide - in mothers and their children compared to a control condition. To investigate these null findings, this study explored participants' perceptions of engagement with the blog and its influence on their dietary behaviours.
DESIGN
Mixed methods process evaluation using a post-intervention satisfaction questionnaire and a content analysis of mothers' comments on the blog (n=213 comments).
SETTING
French-speaking adult mothers living in Quebec City, Quebec, Canada (n=26; response rate = 61.9% of the total sample randomized to exposure to the blog).
RESULTS
Most mothers (n=20/26; 76.9%) perceived the blog useful to improve their dietary habits - with the most appreciated blog features being nutritional information and healthy recipes, and interactions with fellow participants and the RD. Mothers reported several facilitators (e.g., meal planning, and involving children in household food activities) and few barriers (e.g., lack of time, children's food preferences) to maternal and child consumption of vegetables and fruit, and milk and alternatives. Lack of time was the principal reported barrier affecting blog engagement.
CONCLUSIONS
Findings from this study suggest that blogs written by a RD may be an acceptable format of intervention delivery among mothers, but may not alleviate all the barriers to healthy eating and engagement in a dietary intervention.",2020,"Most mothers (n=20/26; 76.9%) perceived the blog useful to improve their dietary habits - with the most appreciated blog features being nutritional information and healthy recipes, and interactions with fellow participants and the RD.","['mothers and their children in a blog-delivered healthy eating intervention', 'groups included in the 2007 version of the Canadian Food Guide - in mothers and their children', ""mothers' comments on the blog (n=213 comments"", 'French-speaking adult mothers living in Quebec City, Quebec, Canada (n=26; response rate ']","['blog written by a registered dietitian (RD) on vegetables and fruit and milk and alternatives (e.g. soy-based beverages, yogurt, cheese) consumption - two food']",[],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}, {'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C2718045', 'cui_str': 'Blogs as Topic'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0007968', 'cui_str': 'Cheese'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",[],,0.0617302,"Most mothers (n=20/26; 76.9%) perceived the blog useful to improve their dietary habits - with the most appreciated blog features being nutritional information and healthy recipes, and interactions with fellow participants and the RD.","[{'ForeName': 'Audrée-Anne', 'Initials': 'AA', 'LastName': 'Dumas', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lapointe', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': 'Centre de recherche Nutrition, Santé et Société (NUTRISS), Institute of Nutrition and Functional Foods, Université Laval, Quebec City, Quebec, Canada.'}]",Public health nutrition,['10.1017/S136898002000484X']
3125,33256869,The impact of the DASH diet on glycaemic control and consumption of processed and ultra-processed foods in pregnant women with pre-gestational diabetes mellitus: a randomized clinical trial.,,2020,,['pregnant women with pre-gestational diabetes mellitus'],['DASH diet'],['glycaemic control and consumption of processed and ultra-processed foods'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}]",,0.110407,,"[{'ForeName': 'Sanmira', 'Initials': 'S', 'LastName': 'Fagherazzi', 'Affiliation': 'Maternity Scholl, Federal University of Rio de Janeiro, R. das Laranjeiras, 180, Bairro Laranjeiras - Rio de Janeiro/RJ - 22240-000 - Brasil.'}, {'ForeName': 'Dayana Rodrigues', 'Initials': 'DR', 'LastName': 'Farias', 'Affiliation': 'Social and Applied Nutrition Department, Josué de Castro Institute of Nutrition, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373 - Bloco J2 - sala 29, Cidade Universitária - Rio de Janeiro/RJ - 21941-590 - Brasil.'}, {'ForeName': 'Gabriella Pinto', 'Initials': 'GP', 'LastName': 'Belfort', 'Affiliation': 'Josué de Castro Institute of Nutrition, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373 - Bloco J2 - sala 26, Cidade Universitária - Rio de Janeiro/RJ - 21941-590 - Brasil.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Dos Santos', 'Affiliation': 'Josué de Castro Institute of Nutrition, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373 - Bloco J2 - sala 26, Cidade Universitária - Rio de Janeiro/RJ - 21941-590 - Brasil.'}, {'ForeName': 'Thaissa Santana Vieira de', 'Initials': 'TSV', 'LastName': 'Lima', 'Affiliation': 'Maternity Scholl, Federal University of Rio de Janeiro, R. das Laranjeiras, 180, Bairro Laranjeiras - Rio de Janeiro/RJ - 22240-000 - Brasil.'}, {'ForeName': 'Mayara Silva Dos', 'Initials': 'MSD', 'LastName': 'Santos', 'Affiliation': 'Maternity Scholl, Federal University of Rio de Janeiro, R. das Laranjeiras, 180, Bairro Laranjeiras - Rio de Janeiro/RJ - 22240-000 - Brasil.'}, {'ForeName': 'Cláudia', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'Maternity Scholl, Federal University of Rio de Janeiro, R. das Laranjeiras, 180, Bairro Laranjeiras - Rio de Janeiro/RJ - 22240-000 - Brasil.'}]",The British journal of nutrition,['10.1017/S0007114520004791']
3126,33256850,Comparative effectiveness of direct admission and admission through emergency departments for children: a randomized stepped wedge study protocol.,"BACKGROUND
Approximately 2 million children are hospitalized each year in the United States, with more than three-quarters of non-elective hospitalizations admitted through emergency departments (EDs). Direct admission, defined as admission to hospital without first receiving care in the hospital's ED, may offer benefits for patients and healthcare systems in quality, timeliness, and experience of care. While ED utilization patterns are well studied, there is a paucity of research comparing the effectiveness of direct and ED admissions. The overall aim of this project is to compare the effectiveness of a standardized direct admission approach to admission beginning in the ED for hospitalized children.
METHODS/DESIGN
We will conduct a stepped wedge cluster randomized controlled trial at 3 structurally and geographically diverse hospitals. A total of 70 primary and urgent care practice sites in the hospitals' catchment areas will be randomized to a time point when they will begin participation in the multi-stakeholder informed direct admission program. This crossover will be unidirectional and occur at 4 time points, 6 months apart, over a 24-month implementation period. Our primary outcome will be the timeliness of clinical care provision. Secondary outcomes include (i) parent-reported experience of care, (ii) unanticipated transfer to the intensive care unit within 6 h of hospital admission, and (iii) rapid response calls within 6 h of hospital admission. We anticipate that 190 children and adolescents will be directly admitted, with 1506 admitted through EDs. Analyses will compare the effectiveness of direct admission to admission through the ED and will evaluate the causal effect of implementing a direct admission program using linear regression with random effects for referring practice clusters and time period fixed effects. We will further examine the heterogeneity of treatment effects based on hypotheses specified a priori. In addition, we will conduct a mixed-methods process evaluation to assess reach, effectiveness, adoption, implementation, and maintenance of our direct admission intervention.
DISCUSSION
Our study represents the first randomized controlled trial to compare the effectiveness of direct admission to admission through the ED for pediatric patients. Our scientific approach, pairing a stepped wedge design with a multi-level assessment of barriers to and facilitators of implementation, will generate valuable data about how positive findings can be reproduced across other healthcare systems.
TRIAL REGISTRATION
ClinicalTrials.gov NCT04192799 . Registered on December 10, 2019).",2020,"The overall aim of this project is to compare the effectiveness of a standardized direct admission approach to admission beginning in the ED for hospitalized children.
","['hospitalized children', '190 children and adolescents will be directly admitted, with 1506 admitted through EDs', 'children', '3 structurally and geographically diverse hospitals', 'pediatric patients', ""A total of 70 primary and urgent care practice sites in the hospitals' catchment areas"", 'Approximately 2 million children are hospitalized each year in the United States, with more than three-quarters of non-elective hospitalizations admitted through emergency departments (EDs']",['direct admission and admission through emergency departments'],"['timeliness of clinical care provision', 'i) parent-reported experience of care, (ii) unanticipated transfer to the intensive care unit within 6\u2009h of hospital admission, and (iii) rapid response calls within 6\u2009h of hospital admission']","[{'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0745036', 'cui_str': 'Elective hospitalization'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0729338', 'cui_str': 'Care provision regime'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",70.0,0.159726,"The overall aim of this project is to compare the effectiveness of a standardized direct admission approach to admission beginning in the ED for hospitalized children.
","[{'ForeName': 'JoAnna K', 'Initials': 'JK', 'LastName': 'Leyenaar', 'Affiliation': ""Department of Pediatrics, Children's Hospital at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA. JoAnna.K.Leyenaar@hitchcock.org.""}, {'ForeName': 'Corrie E', 'Initials': 'CE', 'LastName': 'McDaniel', 'Affiliation': ""Department of Pediatrics, University of Washington, Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Stephanie C', 'Initials': 'SC', 'LastName': 'Acquilano', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Schaefer', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'A James', 'Initials': 'AJ', 'LastName': ""O'Malley"", 'Affiliation': 'The Dartmouth Institute for Health Policy & Clinical Practice, Geisel School of Medicine at Dartmouth College, Hanover, NH, USA.'}]",Trials,['10.1186/s13063-020-04889-9']
3127,33256796,"Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial.","BACKGROUND
Acupuncture, as one of the promising non-pharmacological interventions, has been proved to be beneficial for patients. However, the magnitude of acupuncture's specific and nonspecific effects, as well as their neurological and psychological determinants, remains unclear. Therefore, this study is designed to examine the acupuncture efficacy, investigate whether the brain mechanisms between the specific and nonspecific effects of acupuncture are different, and to evaluate how psychological factors affect the acupuncture effects.
METHODS
This is a randomized, controlled, crossover clinical trial. A total of 60 patients with knee osteoarthritis will receive 4 weeks of acupuncture treatment and 4 weeks of sham acupuncture treatment in a random order separated by a washout period of 2 weeks. The changes in clinical characteristics based on pain-related scales will be assessed to investigate the clinical efficacy of acupuncture. Resting state functional magnetic resonance imaging (fMRI) scans will be used to identify the brain activity changes related to the specific and nonspecific effects of acupuncture. The questionnaires of psychological factors will be used to evaluate patients' psychological properties. Correlation and mediation analyses will be conducted among psychological factors, brain activity changes, and symptoms improvement to explore the neurological and psychological correlates of the acupuncture effects.
DISCUSSION
This study will concentrate on distinguishing and clarifying the specific and nonspecific effects of acupuncture. The results of this study may contribute to rationally optimize the acupuncture therapies by flexible application of the specific and nonspecific effects of acupuncture.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR1900025807 . Registered on 9 September 2019.",2020,"The results of this study may contribute to rationally optimize the acupuncture therapies by flexible application of the specific and nonspecific effects of acupuncture.
","['knee osteoarthritis', '60 patients with knee osteoarthritis']","['acupuncture treatment and 4\u2009weeks of sham acupuncture treatment', 'Resting state functional magnetic resonance imaging (fMRI) scans', 'acupuncture']",[],"[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]",[],60.0,0.11392,"The results of this study may contribute to rationally optimize the acupuncture therapies by flexible application of the specific and nonspecific effects of acupuncture.
","[{'ForeName': 'Jin-Ling', 'Initials': 'JL', 'LastName': 'Li', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Chao-Qun', 'Initials': 'CQ', 'LastName': 'Yan', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'Li-Qiong', 'Initials': 'LQ', 'LastName': 'Wang', 'Affiliation': 'Acupuncture Research Center, School of Acupuncture, Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, 100029, China.'}, {'ForeName': 'You-Sheng', 'Initials': 'YS', 'LastName': 'Qi', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, 100076, China.'}, {'ForeName': 'Jun-Hong', 'Initials': 'JH', 'LastName': 'Liu', 'Affiliation': 'Nanyuan Community Health Service Center, Fengtai District, Beijing, 100076, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'School of Life Sciences, Beijing University of Chinese Medicine, Beijing, 100029, China. wangx@bucm.edu.cn.'}]",Trials,['10.1186/s13063-020-04908-9']
3128,33238442,Influence of Fermented Red Clover Extract on Skeletal Muscle in Early Postmenopausal Women: A Double-Blinded Cross-Over Study.,"Objective: To investigate effects of supplementation with a fermented red clover (RC) extract on signaling proteins related to muscle protein synthesis and breakdown at rest and in response to a resistance exercise bout. Methods: Ten postmenopausal women completed a double-blinded cross-over trial with two different intervention periods performed in random order: (A) RC extract twice daily for 14 days, and (B) placebo drink twice daily for 14 days. The intervention periods were separated by a two-week washout period. After each intervention period a muscle tissue sample was obtained before and three hours after a one-legged resistance exercise bout. Muscle strength was assessed before and after each intervention period. Results: Protein expression of FOXO1 and FOXO3a, two key transcription factors involved in protein degradation, were significantly lower and HSP27, a protein involved in cell protection and prevention of protein aggregation was significantly higher following RC extract compared to placebo. No significant treatment × time interaction was observed for muscle protein expression in response to exercise. However, p-mTOR, p-p70S6k and HSP90 protein content were significantly increased in response to exercise in both groups. Conclusions: This study demonstrates that RC extract supplementation downregulates molecular markers of muscle protein degradation compared to placebo in postmenopausal women.",2020,"However, p-mTOR, p-p70S6k and HSP90 protein content were significantly increased in response to exercise in both groups. ","['postmenopausal women', 'Ten postmenopausal women', 'Early Postmenopausal Women']","['placebo', 'Fermented Red Clover Extract', 'RC extract supplementation', 'RC extract', 'supplementation with a fermented red clover (RC) extract']","['p-mTOR, p-p70S6k and HSP90 protein content', 'muscle protein expression', 'Muscle strength', 'protein aggregation']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0939844', 'cui_str': 'Red Clover Preparation'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C1136240', 'cui_str': 'p70 S6 Kinase'}, {'cui': 'C0243044', 'cui_str': 'Heat-Shock Proteins 90'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}]",10.0,0.0721263,"However, p-mTOR, p-p70S6k and HSP90 protein content were significantly increased in response to exercise in both groups. ","[{'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Oxfeldt', 'Affiliation': 'Department of Public Health, Aarhus University, 8000 Aarhus C, Denmark.'}, {'ForeName': 'Line Barner', 'Initials': 'LB', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Public Health, Aarhus University, 8000 Aarhus C, Denmark.'}, {'ForeName': 'Jeyanthini', 'Initials': 'J', 'LastName': 'Risikesan', 'Affiliation': 'Department of Clinical Medicine, Diabetes and Hormones Diseases, Aarhus University Hospital, 8200 Aarhus N, Denmark.'}, {'ForeName': 'Frank Ted', 'Initials': 'FT', 'LastName': 'Johansen', 'Affiliation': 'Department of Public Health, Aarhus University, 8000 Aarhus C, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Department of Public Health, Aarhus University, 8000 Aarhus C, Denmark.'}]",Nutrients,['10.3390/nu12113587']
3129,33238490,Integrating Nutrition into Outpatient Oncology Care-A Pilot Trial of the NutriCare Program.,"Nutrition is an essential part of oncology care; however, nutrition advice and guidance are not always provided. This six-week pilot pretest-posttest intervention was designed to test the feasibility and effectiveness of integrating a nutrition education program (NutriCare) into outpatient oncology care. Twenty breast cancer survivors were recruited through Tufts Medical Centre. Nutrition impact symptoms and demographics were collected at baseline, dietary quality and quality of life measures were collected pre and post-intervention and an evaluation form was completed post-intervention. Forty-four percent of eligible participants were recruited, and 90% of those completed the study. The NutriCare program was well received with participants reporting that goals were feasible (94.4%), the program had a positive impact on their diet (77.8%), and over 80% would recommend the program. There was an interest in continuing with the program (89%) and in receiving additional guidance from the healthcare team (83%). There was a significant improvement ( p = 0.04) in physical function over the six weeks; however, no additional significant differences in quality of life or dietary quality were seen. In conclusion, cancer survivors were positive about the NutriCare program and its integration into practice.",2020,"There was a significant improvement ( p = 0.04) in physical function over the six weeks; however, no additional significant differences in quality of life or dietary quality were seen.","['Forty-four percent of eligible participants were recruited, and 90% of those completed the study', 'Twenty breast cancer survivors were recruited through Tufts Medical Centre']",['nutrition education program (NutriCare'],"['physical function', 'quality of life or dietary quality', 'dietary quality and quality of life measures']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0302446,"There was a significant improvement ( p = 0.04) in physical function over the six weeks; however, no additional significant differences in quality of life or dietary quality were seen.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Keaver', 'Affiliation': 'Department of Health and Nutritional Science, Institute of Technology Sligo, FP1 YW50 Sligo, Ireland.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Yiannakou', 'Affiliation': 'Department of Medicine, Boston University, Boston, MA 02215, USA.'}, {'ForeName': 'Fang Fang', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': 'Friedman School of Nutrition Science and Policy, Tufts University, Boston, MA 02111, USA.'}]",Nutrients,['10.3390/nu12113590']
3130,31134278,Corrigendum to: Can menstrual health apps selected based on users' needs change health-related factors? A double-blind randomized controlled trial.,,2019,,[],[],[],[],[],[],,0.725061,,[],Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocz083']
3131,29975091,Thinking of oneself as an object of observation reduces reliance on metacognitive information.,"This research explores the consequences of two states of mind on judgment: a subjective state, looking at the world from one's own eyes, and an objective state, in which one thinks of oneself from the imagined perspective of an external observer. In six experiments, we show that judgments people make while they are in a subjective state of mind are more influenced by metacognitive experience compared with judgments people make when they are in an objective state of mind. This is demonstrated in Experiments 1-3, using two different manipulations for the two states of mind and two different fluency tasks. Experiment 4 explores the underlying mechanism and demonstrates that an objective state does not lessen the metacognitive experience itself; rather, it affects the reliance on this experience as a relevant source of information. Finally, in Experiments 5 and 6 we investigate implications of our hypothesis for doing experimental research in psychology. We find that taking part in a laboratory experiment resembles the experimental condition of an objective state of mind, as participants rely less on their metacognition compared with conditions aimed to restore the subjective state of mind within the lab setting. We discuss the theoretical and practical implications of our findings regarding social influences on judgments and decisions in psychology labs and in the real world. (PsycINFO Database Record",2018,"Experiment 4 explores the underlying mechanism and demonstrates that an objective state does not lessen the metacognitive experience itself; rather, it affects the reliance on this experience as a relevant source of information.",[],[],[],[],[],[],,0.0275277,"Experiment 4 explores the underlying mechanism and demonstrates that an objective state does not lessen the metacognitive experience itself; rather, it affects the reliance on this experience as a relevant source of information.","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Noah', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Yaacov', 'Initials': 'Y', 'LastName': 'Schul', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Mayo', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. General,['10.1037/xge0000440']
3132,29121828,"Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.","Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a ""preference option randomized design (PORD)"". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.",2019,"Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.",['Participants who do not independently express explicit alternate preference or assent'],[],[],"[{'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",[],[],,0.123777,"Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.","[{'ForeName': 'Moonseong', 'Initials': 'M', 'LastName': 'Heo', 'Affiliation': '1 Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Meissner', 'Affiliation': '2 Department of Family and Social Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': '3 Department of Medicine, Division of General Internal Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Arnsten', 'Affiliation': '3 Department of Medicine, Division of General Internal Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'M Diane', 'Initials': 'MD', 'LastName': 'McKee', 'Affiliation': '2 Department of Family and Social Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Karasz', 'Affiliation': '2 Department of Family and Social Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKinley', 'Affiliation': '3 Department of Medicine, Division of General Internal Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Colin D', 'Initials': 'CD', 'LastName': 'Rehm', 'Affiliation': '1 Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Earle C', 'Initials': 'EC', 'LastName': 'Chambers', 'Affiliation': '2 Department of Family and Social Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Ming-Chin', 'Initials': 'MC', 'LastName': 'Yeh', 'Affiliation': '5 Nutrition Program, Hunter College, City University of New York, New York, NY, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Wylie-Rosett', 'Affiliation': '1 Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, NY, USA.'}]",Statistical methods in medical research,['10.1177/0962280217734584']
3133,31931509,The acute effects of nicotine on corticostriatal responses to distinct phases of reward processing.,"Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues. This anticipatory effect is selective as no clear evidence has emerged showing that nicotine acutely changes reward receipt reactivity. However, repeated rewarding experiences shift peak brain reactivity from hedonic reward outcome to the motivational anticipatory cue yielding more habitual cue-induced behavior. Given nicotine's influence on NAcc reactivity and connectivity, it is plausible that nicotine acutely induces this shift and alters NAcc functional connectivity during reward processing. To evaluate this currently untested hypothesis, a randomized crossover design was used in which healthy non-smokers were administered placebo and nicotine (2-mg lozenge). Brain activation to monetary reward anticipation and outcome was evaluated with functional magnetic resonance imaging. Relative to placebo, nicotine induced more NAcc reactivity to reward anticipation. Greater NAcc activation during anticipation was significantly associated with lower NAcc activation to outcome. During outcome, nicotine reduced NAcc functional connectivity with cortical regions including the anterior cingulate cortex, orbitofrontal cortex, and insula. These regions showed the same negative relationship between reward anticipation and outcome as noted in the NAcc. The current findings significantly improve our understanding of how nicotine changes corticostriatal circuit function and communication during distinct phases of reward processing and critically show that these alterations happen acutely following a single dose. The implications of this work explain nicotinic modulation of general reward function, which offer insights into the initial drive to smoke and the subsequent difficulty in cessation.",2020,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,['healthy non-smokers'],"['nicotine', 'Nicotine', 'placebo and nicotine (2-mg lozenge', 'placebo, nicotine']","['anterior cingulate cortex, orbitofrontal cortex, and insula', 'Greater NAcc activation', 'habitual cue-induced behavior']","[{'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0321595,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,"[{'ForeName': 'Kainan S', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zegel', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Molokotos', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Lauren V', 'Initials': 'LV', 'LastName': 'Moran', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Olson', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA. ajanes@mclean.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0611-5']
3134,31634766,Cortisol reactivity and situational drug use in cocaine-dependent females.,"In this double-blind study, cocaine-dependent women were administered a pharmacological stressor or placebo prior to two cue-reactivity procedures. The Inventory of Drug Taking Situations is a self-report questionnaire measuring antecedents to relapse and is comprised of three subscales: negative, positive, and temptation situational drug use. It was hypothesized that women with higher IDTS scores would have a greater cortisol response to the cue-reactivity task while receiving yohimbine versus placebo. All three subscales showed significance during the same times after yohimbine administration and immediately post-cue exposure. Our results may suggest an association between situational and physiological risk factors in this population.",2019,All three subscales showed significance during the same times after yohimbine administration and immediately post-cue exposure.,['cocaine-dependent females'],"['placebo', 'pharmacological stressor or placebo', 'yohimbine', 'cocaine']","['Cortisol reactivity and situational drug use', 'cortisol response']","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}]",,0.113887,All three subscales showed significance during the same times after yohimbine administration and immediately post-cue exposure.,"[{'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Campbell', 'Affiliation': 'Addiction Sciences Division, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC 29425, United States. Electronic address: campblau@musc.edu.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Galuska', 'Affiliation': 'Psychology Department, College of Charleston, Charleston, SC 29424, United States.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'McRae-Clark', 'Affiliation': 'Addiction Sciences Division, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC 29425, United States; Ralph H. Johnson VA Medical Center, Charleston, SC 29401, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Sherman', 'Affiliation': 'Addiction Sciences Division, Medical University of South Carolina, 125 Doughty Street, Suite 190, Charleston, SC 29425, United States.'}]",Psychiatry research,['10.1016/j.psychres.2019.112611']
3135,31932868,"Reply to: Josef Tacke, et al. The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.",,2020,,[],['Drug-Eluting Balloons Outperform Standard Balloon Angioplasty'],[],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}]",[],,0.0221498,,"[{'ForeName': 'Haohui', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The Third Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, The Third Affiliated Hospital of Southern Medical University, Guangzhou, Guangdong, China. ny3yxxg@163.com.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02409-5']
3136,31657000,"Commentary for ""The wellness incentive and navigation intervention improved health-related quality of life among medicaid enrollees: A randomized pragmatic clinical trial"".",,2019,,['medicaid enrollees'],['wellness incentive and navigation intervention'],['health-related quality of life'],"[{'cui': 'C0025071', 'cui_str': 'Medicaid'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.102899,,"[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hibbard', 'Affiliation': 'University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Greene', 'Affiliation': 'Baruch College, New York, New York.'}]",Health services research,['10.1111/1475-6773.13234']
3137,31653603,Lessons from the Established Status Epilepticus Treatment Trial.,"Convulsive status epilepticus (SE) is a relatively common emergency condition affecting individuals of all ages. The primary goal of treatment is prompt termination of seizures. Where first-line treatment with benzodiazepine has failed to achieve this, a condition known as established SE (ESE), there is uncertainty about which agent to use next. The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE. Enrollment was completed in January 2019, and the results are expected later this year. We discuss lessons learnt during the conduct of the study in relation to the following: ethical considerations; trial design and practical implementation in emergency settings, including pediatric and adult populations; quality assurance; and outcome determination where treating emergency clinicians may lack specialist expertise. We consider that the ESETT is already informing both clinical practice and future trial design. This article is part of the Special Issue ""Proceedings of the 7th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures"".",2019,"The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE.",['patients aged 2\u202fyears and above with established convulsive SE'],"['benzodiazepine', 'valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0244656', 'cui_str': 'fosphenytoin'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]",[],,0.0900024,"The Established Status Epilepticus Treatment Trial (ESETT) is a 3-arm (valproate (VPA), fosphenytoin (FOS), levetiracetam (LEV)), phase III, double-blind randomized comparative effectiveness study in patients aged 2 years and above with established convulsive SE.","[{'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Cock', 'Affiliation': ""St George's University of London and Atkinson Morley Regional Epilepsy Network, St George's University Hospitals NHS Foundation Trust, London, UK. Electronic address: hannahrc@sgul.ac.uk.""}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Coles', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Silbergleit', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Chamberlain', 'Affiliation': ""Division of Emergency Medicine, Children's National Health System and the Department of Pediatrics and Emergency Medicine, School of Medicine and Health Sciences, George Washington University Washington, DC, USA.""}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Cloyd', 'Affiliation': 'Department of Experimental and Clinical Pharmacology, College of Pharmacy and Center for Orphan Drug Research, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Fountain', 'Affiliation': 'Department of Neurology (Fountain, Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Departments of Neurology, Pediatrics and Epidemiology and Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lowenstein', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Bleck', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jaideep', 'Initials': 'J', 'LastName': 'Kapur', 'Affiliation': 'Department of Neurology (Fountain, Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA; Department of Neuroscience (Kapur), Brain Institute, University of Virginia, Charlottesville, VA, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.04.049']
3138,31610100,Comparing the Pharmacokinetics of 2 Novel Intravenous Tramadol Dosing Regimens to Oral Tramadol: A Randomized 3-Arm Crossover Study.,"Tramadol is a dual-mechanism (opiate and monoamine reuptake inhibition) analgesic. Intravenous (IV) tramadol has been widely prescribed outside the United States. However, there have not been studies comparing the pharmacokinetics (PK) of IV dosing regimens to that of oral tramadol. In this phase 1, open-label, single investigational center, 3-treatment, 3-period, multidose crossover study, we compared 2 novel IV dosing regimens (IV tramadol 75 mg and IV tramadol 50 mg) to oral tramadol 100 mg given every 6 hours (the highest approved oral dosage in the United States) Compared to the oral regimen, IV tramadol 50 mg administered at hours 0, 2, and 4 and every 4 hours thereafter reached initial tramadol peak serum concentration (C max ) more rapidly, while resulting in similar overall steady-state C max and area under the plasma concentration-time curve. IV tramadol 75 mg administered at hours 0, 3, and 6 and every 6 hours thereafter had higher C max and greater fluctuation in peak to trough tramadol concentration. The primary metabolite M1 (a potent μ agonist) had lower area under the plasma concentration-time curve and C max for both IV regimens than for the oral regimen. IV tramadol at both doses was well tolerated, with adverse event profiles consistent with the known pharmacological effects of tramadol. IV tramadol 50 mg is now in phase 3 development in patients with postsurgical pain.",2020,The primary metabolite M1 (a potent µ agonist) had lower area under the plasma concentration-time curve and C max for both IV regimens than for the oral regimen.,['patients with postsurgical pain'],"['tramadol', 'Intravenous (IV) tramadol', 'IV tramadol', 'Tramadol', 'tramadol 75\xa0mg and IV tramadol 50\xa0mg) to oral tramadol']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",[],,0.0214376,The primary metabolite M1 (a potent µ agonist) had lower area under the plasma concentration-time curve and C max for both IV regimens than for the oral regimen.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harnett', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Atiee', 'Affiliation': 'Worldwide Clinical Trials, San Antonio, Texas, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Reines', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.746']
3139,29909398,Higher vitamin D intake could improve sleep and cognitive outcomes in older adults with heart failure.,,2018,,['older adults with heart failure'],['vitamin D intake'],['sleep and cognitive outcomes'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C0564439', 'cui_str': 'Vitamin D intake (observable entity)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]",,0.0188632,,"[{'ForeName': 'Junxin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'University of Pennsylvania School of Nursing, Philadelphia, Pennsylvania, USA.'}]",Evidence-based nursing,['10.1136/eb-2018-102947']
3140,32162946,"How much bias results if a quasi-experimental design combines local comparison groups, a pretest outcome measure and other covariates?: A within study comparison of preschool effects.","This study uses a within study comparison design (WSC) to conduct a novel test of how much causal bias results when researchers use a nonequivalent comparison group design type (NECGD) that combines: (a) a comparison group local to the treatment group; (b) a pretest measure of the study outcome; and (c) a rich set of 19 other multidimensional covariates. Most prior WSCs have dealt with the bias consequences of only 1 of these, revealing that each routinely reduces bias but does not necessarily eliminate it. Thus, a need exists to identify NECGDs that more robustly eliminate bias. This study is the first to examine how combining the 3 bias-control mechanisms above affects bias. The intervention we examine is a prekindergarten mathematics curriculum, for which a randomized control trial (RCT) produces a positive 1-year math effect. Final bias in the NECGD is assessed as the difference between its impact and that of the RCT when each design has the same intervention, outcome, and estimand. Over the many specifications we explore, NECGD bias is less than .10 standard deviations, indicating that minimal bias results when an NECGD combines all 3 design elements. The factorial design we use in this study also tests the bias associated with seven other NECGD types. Comparing the total pattern of results shows that the minimal bias when all 3 elements are combined is uniquely attributable to the locally chosen comparison group and not the availability of a pretest or other covariates. In actual research practice, it is impossible to predict in advance which design elements will affect bias by how much in any given application. So further research is needed to probe whether the simultaneous use of all three design elements achieves minimal bias dependably across diverse applications and not just in the preschool math context examined here. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Over the many specifications we explore, NECGD bias is less than .10 standard deviations, indicating that minimal bias results when an NECGD combines all 3 design elements.",[],[],[],[],[],[],,0.0194017,"Over the many specifications we explore, NECGD bias is less than .10 standard deviations, indicating that minimal bias results when an NECGD combines all 3 design elements.","[{'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cook', 'Affiliation': 'Department of Psychology, Northwestern University.'}, {'ForeName': 'Naixin', 'Initials': 'N', 'LastName': 'Zhu', 'Affiliation': 'Trachtenberg School of Public Policy, George Washington University.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Klein', 'Affiliation': 'WestEd.'}, {'ForeName': 'Prentice', 'Initials': 'P', 'LastName': 'Starkey', 'Affiliation': 'WestEd.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Mathematica Policy Research.'}]",Psychological methods,['10.1037/met0000260']
3141,32058422,Letter to the Editor: Combined Intravenous and Intraarticular Tranexamic Acid Does Not Offer Additional Benefit Compared with Intraarticular Use Alone in Bilateral TKA: A Randomized Controlled Trial.,,2020,,['Bilateral TKA'],"['Intraarticular Tranexamic Acid', 'Letter to the Editor']",[],"[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",[],,0.143475,,"[{'ForeName': 'Xiang-Dong', 'Initials': 'XD', 'LastName': 'Wu', 'Affiliation': 'X-D Wu, D. Wu, Y. Liu, Department of Orthopaedic Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. W. Huang, Department of Orthopaedic Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001158']
3142,32191129,The cluster randomized crossover trial: The effects of attrition in the AB/BA design and how to account for it in sample size calculations.,"BACKGROUND/AIMS
This article studies the effect of attrition in the cluster randomized crossover trial. The focus is on the two-treatment two-period AB/BA design where attrition occurs during the washout period. Attrition may occur at either the subject level or the cluster level. In the latter case, clusters drop out entirely and provide no measurements in the second period. Subject attrition can only occur in the cohort design, where each subject receives both treatments. Cluster attrition can also occur in the cross-sectional design, where different subjects are measured in the two time periods. Furthermore, this article explores two different strategies to account for potential levels of attrition: increasing sample size and replacing those subjects who drop out by others.
METHODS
The statistical model that takes into account the nesting of subjects within clusters, and the nesting of repeated measurements within subjects is presented. The effect of attrition is evaluated on the basis of the efficiency of the treatment effect estimator. Matrix algebra is used to derive the relation between efficiency, the degree of attrition, cluster size and the intraclass correlations: the within-cluster within-period correlation, the within-cluster between-period correlation and (in the case of a cohort design) the within-subject correlation. The methodology is implemented in two Shiny Apps.
RESULTS
Attrition in a cluster randomized crossover trial implies a loss of efficiency. Efficiency decreases with an increase of the attrition rate. The loss of efficiency due to attrition of subjects in a cohort design is largest for small number of subjects per cluster-period, but it may be repaired to a large degree by increasing the number of subjects per cluster-period or by replacing those subjects who drop out by others. Attrition of clusters results in a larger loss of efficiency, but this loss does not depend on the number of subjects per cluster-period. Repairing for this loss requires a large increase in the number of subjects per cluster-period. The methodology of this article is illustrated by an example on the effect of lavender scent on dental patients' anxiety.
CONCLUSION
This article provides the methodology of exploring the effect of attrition in cluster randomized crossover trials, and to repair for attrition. As such, it helps researchers plan their trial in an appropriate way and avoid underpowered trials. To use the methodology, prior estimates of the degree of attrition and intraclass correlation coefficients are needed. It is advocated that researchers clearly report the estimates of these quantities to help facilitate planning future trials.",2020,"Matrix algebra is used to derive the relation between efficiency, the degree of attrition, cluster size and the intraclass correlations: the within-cluster within-period correlation, the within-cluster between-period correlation and (in the case of a cohort design) the within-subject correlation.","[""dental patients' anxiety""]",['lavender scent'],['attrition rate'],"[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C2987717', 'cui_str': 'Aroma'}]",[],,0.028077,"Matrix algebra is used to derive the relation between efficiency, the degree of attrition, cluster size and the intraclass correlations: the within-cluster within-period correlation, the within-cluster between-period correlation and (in the case of a cohort design) the within-subject correlation.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Moerbeek', 'Affiliation': 'Department of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.'}]","Clinical trials (London, England)",['10.1177/1740774520913042']
3143,32022470,Expectancy and Utilisation of Reflexology among Women with Advanced Breast Cancer.,"OBJECTIVE
Little is understood about patient expectations and use of complementary therapies (CT) during cancer treatment. A secondary analysis of an 11-week reflexology trial among women with breast cancer was conducted. We examined factors that predicted women's expectations about reflexology for symptom relief, factors that predicted utilisation of reflexology, and whether by the end of the trial they believed that reflexology had helped with symptom management.
METHODS
Women (N = 256) were interviewed at baseline and week 11. Friend or family caregivers in the reflexology group were trained to deliver standardised sessions to patients at least once a week for 4 weeks. Baseline and week-11 reflexology expectations were analysed using general linear models. Reflexology utilisation was analysed with generalised linear mixed effects models.
RESULTS
Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use. Worsening symptoms over time were associated with greater utilisation of reflexology, but only when baseline expectancy was low. At week 11, expectancy was higher for those with greater symptom improvement.
CONCLUSIONS
Assessing patterns of patient factors, expectancy, and change in symptoms can help determine who is likely to use reflexology, and when.",2020,"RESULTS
Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use.","['women with breast cancer', 'Women (N\xa0=\xa0256', 'Women with Advanced Breast Cancer']",[],"['Expectancy and Utilisation of Reflexology', 'Reflexology utilisation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]",[],"[{'cui': 'C0034945', 'cui_str': 'Reflexology'}]",256.0,0.0543432,"RESULTS
Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Rottman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Wyatt', 'Affiliation': 'Michigan State University College of Nursing, East Lansing, MI, USA.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Crane', 'Affiliation': 'University of Arizona College of Nursing, Tucson, AZ, USA.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12194']
3144,32034079,Not Yet Another Negative Trial-ReACTing on Recent Glioblastoma Trials.,"The present ReACT trial provides data from a small randomized controlled vaccination trial that in addition to other recent immunotherapy trials in glioblastoma allows sketching a rational, advanced trial design for the development of (immune) therapies in glioblastoma elaborating on but not restricting to biological monitoring and endpoints. See related article by Reardon et al., p. 1586 .",2020,"The present ReACT trial provides data from a small randomized controlled vaccination trial that in addition to other recent immunotherapy trials in glioblastoma allows sketching a rational, advanced trial design for the development of (immune)therapies in glioblastoma elaborating on but not restricting to biological monitoring and endpoints.",[],[],[],[],[],[],,0.202118,"The present ReACT trial provides data from a small randomized controlled vaccination trial that in addition to other recent immunotherapy trials in glioblastoma allows sketching a rational, advanced trial design for the development of (immune)therapies in glioblastoma elaborating on but not restricting to biological monitoring and endpoints.","[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'University Medical Center & German Cancer Research Center, Heidelberg, Germany. wolfgang.wick@med.uni-heidelberg.de.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Wagener', 'Affiliation': 'University Medical Center & German Cancer Research Center, Heidelberg, Germany.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-4032']
3145,31980016,Efficiency as a determinant of loyalty among users of a Community of Clinical Practice: a comparative study between the implementation and consolidation phases.,"BACKGROUND
A community of clinical practice called the Online Communication Tool between Primary and Hospital Care (ECOPIH) was created to enable primary care and specialist care professionals to communicate with each other in order to resolve real clinical cases, thereby improving communication and coordination between care levels. The present work seeks to analyse whether ECOPIH makes it possible to reduce the number of referrals. To that end, the objectives are: (1) To find out the degree of loyalty among ECOPIH users, by comparing the medical professionals' profiles in the tool's implementation phase to those in its consolidation phase. (2) To evaluate the degree of fulfilment of users' expectations, by establishing the determining factors that had an influence on the physicians' intention to use ECOPIH in the implementation phase and observing whether its use had an effective, direct impact on the number of patient referrals that primary care physicians made to specialist care professionals.
METHODS
Two studies were conducted. Based on a survey of all the physicians in a Primary Care area, Study 1 was a descriptive study in ECOPIH's implementation phase. Study 2 was a randomised intervention study of ECOPIH users in the tool's consolidation phase. The results from both studies were compared. Various bivariate and multivariate statistical techniques (exploratory factor analysis, cluster analysis, logistic regression analysis and ANOVA) were used in both studies, which were conducted on a sample of 111 and 178 physicians, respectively.
RESULTS
We confirmed the existence of an ECOPIH user profile stable across both phases: under-50-year-old women. Regarding the second objective, there were two particular findings. First, the discriminant factors that had an influence on greater ECOPIH use were habitual Social media website and app use and Perceived usefulness for reducing costs. Second, PC professionals who were ECOPIH members made fewer referrals to SC professionals in Cardiology, Endocrinology and Gastroenterology than older PC professionals who were not ECOPIH members.
CONCLUSIONS
The use of a community of clinical practice by primary care and specialist care professionals helps to reduce the number of referrals among medical professionals.",2020,The use of a community of clinical practice by primary care and specialist care professionals helps to reduce the number of referrals among medical professionals.,['users of a Community of Clinical Practice'],['ECOPIH'],[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",[],[],,0.0211168,The use of a community of clinical practice by primary care and specialist care professionals helps to reduce the number of referrals among medical professionals.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lacasta Tintorer', 'Affiliation': ""Centre d'Atenció Primària Gran Sol, Gerència d'Àmbit d'Atenció Primària Metropolitana Nord, Institut Català de la Salut. Avinguda del Doctor Bassols, 112 - 130, 08914, Badalona, Spain.""}, {'ForeName': 'Josep Maria', 'Initials': 'JM', 'LastName': 'Manresa Domínguez', 'Affiliation': 'Unitat de Suport a la Recerca Metropolitana Nord, IDIAP Jordi Gol, CAP El Maresme. Camí del Mig, 36 planta 4ª, 08303, Mataró, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Jiménez-Zarco', 'Affiliation': 'Faculty of Economics and Business, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Rodríguez-Blanco', 'Affiliation': 'Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès. Campus de la UAB, Plaça Cívica, s/n, 08193 Bellaterra, Barcelona, Spain.'}, {'ForeName': 'Souhel', 'Initials': 'S', 'LastName': 'Flayeh Beneyto', 'Affiliation': ""Centre d'Atenció Primària Gran Sol, Gerència d'Àmbit d'Atenció Primària Metropolitana Nord, Institut Català de la Salut. Avinguda del Doctor Bassols, 112 - 130, 08914, Badalona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Torán-Monserrat', 'Affiliation': 'Unitat de Suport a la Recerca Metropolitana Nord, IDIAP Jordi Gol, CAP El Maresme. Camí del Mig, 36 planta 4ª, 08303, Mataró, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mundet Tuduri', 'Affiliation': 'Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès. Campus de la UAB, Plaça Cívica, s/n, 08193 Bellaterra, Barcelona, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Saigí-Rubió', 'Affiliation': 'Faculty of Health Sciences, Universitat Oberta de Catalunya, Barcelona. Av. Tibidabo, 39-43, 08035, Barcelona, Spain. fsaigi@uoc.edu.'}]",BMC family practice,['10.1186/s12875-020-1081-x']
3146,32165066,Re: Randomized Trial of Partial Gland Ablation with Vascular Targeted Phototherapy Versus Active Surveillance for Low Risk Prostate Cancer: Extended Followup and Analyses of Effectiveness.,,2020,,['Low Risk Prostate Cancer'],['Partial Gland Ablation with Vascular Targeted Phototherapy'],[],"[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]",[],,0.0719374,,"[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Wirth', 'Affiliation': 'University Medical Clinic, University of Dresden, Dresden, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stief', 'Affiliation': 'Department of Urology, University Medical Clinic of Munich, Munich, Germany.'}, {'ForeName': 'Arnulf', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, University Medical Clinic of Tübingen, Tübingen, Germany. Electronic address: Arnulf.Stenzl@med.uni-tuebingen.de.'}]",European urology,['10.1016/j.eururo.2020.02.023']
3147,32026592,The effect of dapagliflozin on apolipoprotein B and glucose fluxes in patients with type 2 diabetes and well-controlled plasma LDL cholesterol.,"AIM
To dissect the effects of the sodium-glucose linked transporter 2 inhibitor dapagliflozin on lipid metabolism and assess whether these effects could potentially offset cardiovascular benefit with this drug-class.
MATERIALS AND METHODS
We assessed the effect of dapagliflozin on lipid metabolism in 11 adults with uncomplicated type 2 diabetes. After 4 weeks of statin wash-out and 4 weeks of rosuvastatin 10 mg treatment, participants were treated with dapagliflozin 10 mg once-daily for 5 weeks. Before and after dapagliflozin, plasma lipids were measured and very low-density lipoprotein (VLDL)-1 and VLDL-2 apolipoprotein (Apo)B fluxes were assessed using (5.5.5- 2 H 3 )-leucine tracer infusion. In addition, hepatic and peripheral insulin sensitivity as well as insulin-mediated inhibition of peripheral lipolysis were measured during a two-step hyperinsulinemic-euglycaemic clamp using (6,6- 2 H 2 )-glucose and (1,1,2,3,3- 2 H 5 )-glycerol tracers.
RESULTS
Rosuvastatin decreased all plasma lipids significantly: total cholesterol from 4.5 (3.2-6.2) to 3.1 (2.5-3.8) mmol/L, LDL cholesterol from 2.6 (1.7-3.4) to 1.5 (1.1-2.2) mmol/L, HDL cholesterol from 1.34 (0.80-2.02) to 1.19 (0.74-1.89) mmol/L and triglycerides from 0.92 (0.31-3.91) to 0.79 (0.32-2.10) mmol/L. The addition of dapaglifozin to rosuvastatin did not raise either LDL cholesterol or total cholesterol, and only increased HDL cholesterol by 0.08 (-0.03-0.13) mmol/L (P = 0.03). In line with this, dapagliflozin did not affect VLDL-1 or VLDL-2 ApoB fluxes. Fasting endogenous glucose production tended to increase by 0.9 (-3.4-3.1) μmol kg -1 min -1 (P = 0.06), but no effect on hepatic and peripheral insulin sensitivity or on peripheral lipolysis was observed.
CONCLUSIONS
Dapagliflozin has no effect on plasma LDL-cholesterol levels or VLDL-apoB fluxes in the context of optimal lipid-lowering treatment, which will thus not limit cardiovascular benefit when lipids are adequately controlled.",2020,"(P = 0.06), but no effect on hepatic and peripheral insulin sensitivity or on peripheral lipolysis was observed.
","['patients with type 2 diabetes and well-controlled plasma LDL cholesterol', '11 adults with uncomplicated type 2 diabetes']","['Rosuvastatin', 'dapagliflozin', 'Dapagliflozin', 'dapagliflozin 10\u2009mg once-daily for 5\u2009weeks', 'sodium-glucose linked transporter 2 inhibitor dapagliflozin', 'rosuvastatin', 'dapaglifozin to rosuvastatin']","['hepatic and peripheral insulin sensitivity or on peripheral lipolysis', 'plasma LDL-cholesterol levels', 'VLDL-1 or VLDL-2 ApoB fluxes', 'low-density lipoprotein (VLDL)-1 and VLDL-2 apolipoprotein (Apo)B fluxes', 'LDL cholesterol', 'HDL cholesterol', 'plasma lipids', 'lipid metabolism', 'hepatic and peripheral insulin sensitivity', 'LDL cholesterol or total cholesterol', 'Fasting endogenous glucose production', 'apolipoprotein B and glucose fluxes', 'plasma lipids significantly: total cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023169', 'cui_str': 'Low-Density Lipoprotein 1'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}]",11.0,0.0484871,"(P = 0.06), but no effect on hepatic and peripheral insulin sensitivity or on peripheral lipolysis was observed.
","[{'ForeName': 'Kristien E C', 'Initials': 'KEC', 'LastName': 'Bouter', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Jansen', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'van Harskamp', 'Affiliation': 'Department of Clinical Chemistry, Laboratory of Endocrinology, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schierbeek', 'Affiliation': 'Department of Clinical Chemistry, Laboratory of Endocrinology, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Mariëtte T', 'Initials': 'MT', 'LastName': 'Ackermans', 'Affiliation': 'Department of Clinical Chemistry, Laboratory of Endocrinology, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Mireille J', 'Initials': 'MJ', 'LastName': 'Serlie', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Alinda W M', 'Initials': 'AWM', 'LastName': 'Schimmel', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Geesje M', 'Initials': 'GM', 'LastName': 'Dallinga-Thie', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13990']
3148,31902373,Acute whole apple consumption did not influence postprandial lipaemia: a randomised crossover trial.,"Whole apples are a source of pectin and polyphenols, both of which show potential to modulate postprandial lipaemia (PPL). The present study aimed to explore the effects of whole apple consumption on PPL, as a risk factor for CVD, in generally healthy but overweight and obese adults. A randomised, crossover acute meal trial was conducted with seventeen women and nine men (mean BMI of 34·1 (sem 0·2) kg/m2). Blood samples were collected for 6 h after participants consumed an oral fat tolerance test meal that provided 1 g fat/kg body weight and 1500 mg acetaminophen per meal for estimating gastric emptying, with and without three whole raw Gala apples (approximately 200 g). Plasma TAG (with peak postprandial concentration as the primary outcome), apoB48, chylomicron-rich fraction particle size and fatty acid composition, glucose, insulin and acetaminophen were analysed. Differences between with and without apples were identified by ANCOVA. Apple consumption did not alter postprandial TAG response, chylomicron properties, glucose or acetaminophen (P > 0·05), but did lead to a higher apoB48 peak concentration and exaggerated insulin between 20 and 180 min (P < 0·05). Overall, as a complex food matrix, apples did not modulate postprandial TAG when consumed with a high-fat meal in overweight and obese adults, but did stimulate insulin secretion, potentially contributing to an increased TAG-rich lipoprotein production.",2020,"Apple consumption did not alter postprandial TAG response, chylomicron properties, glucose or acetaminophen (P>0.05), but did lead to a higher apoB48 peak concentration and exaggerated insulin between 20-180 min (P<0.05).","['17 women and 9 men (mean body mass index of 34.1 (SEM 0.2) kg/m2', 'generally healthy but overweight and obese adults']","['acetaminophen', 'whole apple consumption']","['postprandial TAG response, chylomicron properties, glucose or acetaminophen', 'postprandial lipemia', 'Plasma triacylglycerol (TAG, with peak postprandial concentration', 'apolipoprotein B-48 (apoB48), chylomicron-rich fraction (CMRF) particle size and fatty acid composition, glucose, insulin and acetaminophen']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C1706412', 'cui_str': 'Lipemia'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0103839', 'cui_str': 'Chylomicron Apo B'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",180.0,0.0718174,"Apple consumption did not alter postprandial TAG response, chylomicron properties, glucose or acetaminophen (P>0.05), but did lead to a higher apoB48 peak concentration and exaggerated insulin between 20-180 min (P<0.05).","[{'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, CanadaN1G 2W1.'}, {'ForeName': 'Danyelle M', 'Initials': 'DM', 'LastName': 'Liddle', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, CanadaN1G 2W1.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Neizer', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, CanadaN1G 2W1.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Robinson', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, CanadaN1G 2W1.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Department of Human Health and Nutritional Sciences, University of Guelph, Guelph, Ontario, CanadaN1G 2W1.'}]",The British journal of nutrition,['10.1017/S0007114519003441']
3149,31833000,IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial.,"BACKGROUND
Diclofenac potassium for oral solution (CAMBIA®) may be an alternative for patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac. CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction. This study assessed for efficacy of CAMBIA® as an alternative outpatient treatment for refractory migraine to parenteral ketorolac.
METHODS
We performed an exploratory, single-center, double-blind, double-dummy randomized controlled trial comparing CAMBIA® with IM ketorolac. Participants were randomized to receive either ketorolac 60 mg IM with dummy oral solution or CAMBIA® 50 mg, together with IM injection of normal saline. The primary endpoint was headache severity, self-rated on a scale 0-3. Secondary endpoints included self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy.
RESULTS
A total of 23 patients were enrolled. Ten patients received the study drug and 13 patients received IM ketorolac as the control. There were no major differences observed with respect to the primary outcome of mean headache severity at successive time points over a 24-h follow-up period. No major differences were found with respect to average disability, nausea, and photo- or phonophobia ratings. No major adverse events were reported.
CONCLUSION
In treatment of refractory migraine headache, CAMBIA® may provide similar benefits as IM ketorolac without increasing the risk of treatment failure, major bleeding, or cardiovascular events. However, larger studies are needed to confirm this finding.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT # 02664116, Titled ""IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®) for the Acute Treatment of Severe Migraine"". Registered 26 January 2016, https://clinicaltrials.gov/ct2/show/NCT02664116?term=02664116&rank=1.",2020,CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction.,"['patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac', 'severe migraine', '23 patients were enrolled']","['Diclofenac potassium for oral solution (CAMBIA®', 'diclofenac potassium powder', 'CAMBIA®', 'IM ketorolac', 'CAMBIA® with IM ketorolac', 'ketorolac 60\xa0mg IM with dummy oral solution or CAMBIA® 50\xa0mg, together with IM injection of normal saline', 'Titled ""IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®']","['mean headache severity', 'average disability, nausea, and photo- or phonophobia ratings', 'risk of treatment failure, major bleeding, or cardiovascular events', 'headache severity, self-rated on a scale 0-3', 'self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}]","[{'cui': 'C0282131', 'cui_str': 'Diclofenac Potassium'}, {'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C2718733', 'cui_str': 'Cambia'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1273621', 'cui_str': 'Powder for Oral Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0751466', 'cui_str': 'Phonophobia'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162643'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0222045'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",23.0,0.225106,CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction.,"[{'ForeName': 'Emily Rubenstein', 'Initials': 'ER', 'LastName': 'Engel', 'Affiliation': 'Dalessio Headache Center Scripps Clinic Division of Neurology, 10666 North Torrey Pines Rd. MS 313, La Jolla, CA, 92037, USA. Engel.Emily@scrippshealth.org.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Scripps Green Hospital, SCMG Hospitalists, 10666 N. Torrey Pines Rd, La Jolla, CA, 92037, USA.'}]",Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology,['10.1007/s10072-019-04157-y']
3150,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE
To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS
This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS
There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION
The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3151,32089223,Do Recent Randomized Trial Results Influence which Patients with Myelodysplastic Syndromes Receive Iron Chelation?,"Iron overload (IOL) in patients with myelodysplastic syndromes (MDS) is mainly attributable to chronic transfusion therapy. The importance of iron chelation therapy (ICT) in MDS has been a matter of debate. The Telesto study, the only randomized, placebo-controlled trial of ICT with deferasirox in MDS, showed improved event-free survival with ICT in patients with lower-risk MDS. Although Telesto was not powered to detect differences between deferasirox and placebo for single-event categories of the composite primary endpoint for event-free survival, results are consistent with the view that iron-related cardiac dysfunction is ameliorated by ICT in elderly patients with MDS.",2020,"Although Telesto was not powered to detect differences between deferasirox and placebo for single-event categories of the composite primary endpoint for event-free survival, results are consistent with the view that iron-related cardiac dysfunction is ameliorated by ICT in elderly patients with MDS.","['patients with lower-risk MDS', 'patients with myelodysplastic syndromes (MDS', 'elderly patients with MDS', 'Patients with Myelodysplastic Syndromes']","['placebo', 'ICT', 'iron chelation therapy (ICT']",['Iron overload (IOL'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C3666007', 'cui_str': 'Myelodysplastic syndrome (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}]","[{'cui': 'C0282193', 'cui_str': 'Iron Overload'}]",,0.111837,"Although Telesto was not powered to detect differences between deferasirox and placebo for single-event categories of the composite primary endpoint for event-free survival, results are consistent with the view that iron-related cardiac dysfunction is ameliorated by ICT in elderly patients with MDS.","[{'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Gattermann', 'Affiliation': 'Department of Hematology, Oncology and Clinical Immunology, Heinrich Heine University Düsseldorf, Moorenstr. 5, Düsseldorf 40225, Germany. Electronic address: gattermann@med.uni-duesseldorf.de.'}]",Hematology/oncology clinics of North America,['10.1016/j.hoc.2019.10.006']
3152,32124456,Evaluation of a sterile surgical skin marker to indicate the optimal vein for venepuncture in the blood donation setting.,"BACKGROUND AND OBJECTIVES
Phlebotomy is a central task for blood donation; however, not all blood donors have veins that are easy to see or feel. This study aimed to determine whether use of a surgical skin marker to highlight the donors' vein location and direction prior to venepuncture increased blood donation success.
METHODS
All blood donors who participated in this study were eligible to donate according to Australian guidelines. Ten donor centres with phlebotomy success rates <95% were selected. A randomized cluster trial design assigned five sites to test the skin marking device and five sites as controls. Single-use sterile Gentian violet skin marker pens were used to mark donors' veins. Phlebotomy site skin bacterial load after using the skin marking device was tested on a subset of 100 donors. Phlebotomy success rates and donor adverse events were recorded.
RESULTS
Of the control donors, 6993 had successful phlebotomies and 225 failed. Of the skin marker donors, 6998 had successful phlebotomies and 248 failed. No statistically significant differences in phlebotomy success were found between the two groups (OR: 0·91, 96·4% CI [96·0, 96·8], P-value 0·348).
CONCLUSION
The use of skin marker pens did not increase overall phlebotomy success rate. There was no increase in phlebotomy site skin bacterial load, and amendments to standard skin disinfection techniques were not required. Blood donors were not concerned about the pen mark on their arms. Generally, staff indicated that the markers may be valuable to assist with phlebotomies for donors with difficult or deep veins.",2020,"No statistically significant differences in phlebotomy success were found between the two groups (OR: 0·91, 96·4% CI [96·0, 96·8], P-value 0·348).
","['Of the skin marker donors, 6998 had successful phlebotomies and 248 failed', 'All blood donors who participated in this study were eligible to donate according to Australian guidelines', 'Ten donor centres with phlebotomy success rates <95% were selected']",['Single-use sterile Gentian violet skin marker pens'],"['Phlebotomy success rates and donor adverse events', 'phlebotomy site skin bacterial load, and amendments to standard skin disinfection techniques', 'overall phlebotomy success rate', 'phlebotomy success']","[{'cui': 'C0181740', 'cui_str': 'Skin marker (physical object)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0005795', 'cui_str': 'Blood donor (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0017440', 'cui_str': 'Gentian Violet'}, {'cui': 'C0181740', 'cui_str': 'Skin marker (physical object)'}, {'cui': 'C4319659', 'cui_str': 'Pen (unit of presentation)'}]","[{'cui': 'C0190979', 'cui_str': 'Venesection'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1698034', 'cui_str': 'Skin disinfection'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0199904,"No statistically significant differences in phlebotomy success were found between the two groups (OR: 0·91, 96·4% CI [96·0, 96·8], P-value 0·348).
","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Bell', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, Australia.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': ""O'Donovan"", 'Affiliation': 'Australian Red Cross Blood Service, Sydney, Australia.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Wright', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, Australia.'}, {'ForeName': 'Carley N', 'Initials': 'CN', 'LastName': 'Gemelli', 'Affiliation': 'Australian Red Cross Blood Service, Melbourne, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Knight', 'Affiliation': 'Australian Red Cross Blood Service, Melbourne, Australia.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Hirani', 'Affiliation': 'Australian Red Cross Blood Service, Sydney, Australia.'}]",Vox sanguinis,['10.1111/vox.12904']
3153,32113735,Feasibility and acceptability of conducting a partially randomised controlled trial examining interventions to improve psychological health after discharge from the intensive care unit.,"BACKGROUND
Interventions to support psychological recovery after critical illness, including information provision via an intensive care unit (ICU) diary or discharge summary, have been widely adopted in some regions, albeit without strong empirical evidence.
OBJECTIVE
The objective of this study was to examine the feasibility and acceptability, for patients, family members, and clinicians, of information provision via an ICU diary or discharge summary to support psychological recovery for critical illness survivors.
METHODS
This was a pilot, partially randomised patient preference study in a mixed ICU in a tertiary hospital in Australia. Eligible patients were those in the ICU for >24 h and who were able to converse in English. Interventions were ICU diary or discharge summary compared with usual care. Feasibility was assessed throughout the study process, and acceptability assessed 3 and 6 months after hospital discharge, with data analysed descriptively and thematically.
RESULTS
Sixty-one patients were recruited; 45 completed 3-month follow-up (74%), and 37 (61%), 6-month follow-up. Participants were medical (39%), surgical (30%), and trauma (31%) patients; aged 55 [interquartile range (IQR): 36-67] years; and stayed in the ICU for 7 [IQR: 3-13] days and hospital for 23 [IQR: 14-32] days. Within the partially randomised framework, 34 patients chose their intervention - four chose usual care, 10 ICU diary, and 20 discharge summary. The remaining 27 patients were randomised - nine usual care, 10 ICU diary, and seven discharge summary. The majority (>90%) considered each intervention helpful during recovery; however, a significant proportion of patients reported distress associated with reading the ICU diary (42%) or discharge summary (15%). Clinicians reported they were hesitant to make diary entries.
CONCLUSIONS
When given a choice, more patients chose a discharge summary over the ICU diary or usual care. Participants considered both interventions acceptable. Given the reports of distress associated with information provision, clear empirical evidence is required to determine effectiveness, optimal timing, support needed, and for whom they should be used.
CLINICAL TRIAL REGISTRATION NUMBER
ACTRN12615001079538.",2020,"The majority (>90%) considered each intervention helpful during recovery; however, a significant proportion of patients reported distress associated with reading the ICU diary (42%) or discharge summary (15%).","['Sixty-one patients were recruited; 45 completed 3-month follow-up (74%), and 37 (61%), 6-month follow-up', 'partially randomised patient preference study in a mixed ICU in a tertiary hospital in Australia', 'patients, family members, and clinicians, of information provision via an ICU diary or discharge summary to support psychological recovery for critical illness survivors', '34 patients chose their intervention - four chose usual care, 10 ICU diary, and 20 discharge summary', 'Eligible patients were those in the ICU for >24\xa0h and who were able to converse in English', 'Participants were medical (39%), surgical (30%), and trauma (31%) patients; aged 55 [interquartile range\xa0(IQR): 36-67] years; and stayed in the ICU for 7 [IQR: 3-13] days and hospital for 23 [IQR: 14-32] days']",[],"['psychological health', 'ICU diary or discharge summary', 'feasibility and acceptability']","[{'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0743221', 'cui_str': 'Discharge summary (record artifact)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205450', 'cui_str': '4'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1299581', 'cui_str': 'Able'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0743221', 'cui_str': 'Discharge summary (record artifact)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",61.0,0.15121,"The majority (>90%) considered each intervention helpful during recovery; however, a significant proportion of patients reported distress associated with reading the ICU diary (42%) or discharge summary (15%).","[{'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Castillo', 'Affiliation': 'School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, Nathan Campus N48 2.14, 170 Kessels Road, Nathan, Brisbane, 4111, QLD, Australia. Electronic address: i.castillo.esc@gmail.com.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mitchell', 'Affiliation': 'School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, Nathan Campus N48 2.14, 170 Kessels Road, Nathan, Brisbane, 4111, QLD, Australia. Electronic address: marion.mitchell@griffith.edu.au.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Building 53 Level 4, 199 Ipswich Road, Woolloongabba, Brisbane, 4102, QLD, Australia. Electronic address: davischelsea6@gmail.com.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Powell', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Building 53 Level 4, 199 Ipswich Road, Woolloongabba, Brisbane, 4102, QLD, Australia. Electronic address: Madeleine.Powell@health.qld.gov.au.'}, {'ForeName': 'Robyne', 'Initials': 'R', 'LastName': 'Le Brocque', 'Affiliation': 'School of Nursing, Midwifery, and Social Work, University of Queensland, Chamberlain Building (35) Level 3, St Lucia, Brisbane, 4072, QLD, Australia. Electronic address: r.lebrocque@uq.edu.au.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Ullman', 'Affiliation': 'School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, Nathan Campus N48 2.14, 170 Kessels Road, Nathan, Brisbane, 4111, QLD, Australia. Electronic address: a.ullman@griffith.edu.au.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Wetzig', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Building 53 Level 4, 199 Ipswich Road, Woolloongabba, Brisbane, 4102, QLD, Australia. Electronic address: Krista.Wetzig@health.qld.gov.au.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Rattray', 'Affiliation': 'School of Nursing and Health Sciences, University of Dundee, 11 Airlie Place, Dundee, DD1 4HJ, United Kingdom. Electronic address: j.z.rattray@dundee.ac.uk.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Hull', 'Affiliation': 'Institute of Medical Sciences, University of Dundee, Dundee, DD1 9SY, United Kingdom. Electronic address: ahull@nhs.net.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Kenardy', 'Affiliation': 'School of Psychology, University of Queensland, McElwain Building (24A) Level 4, Room 408, St Lucia, Brisbane, 4072, QLD, Australia. Electronic address: j.kenardy@uq.edu.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Nursing and Midwifery, Menzies Health Institute Queensland, Griffith University, Nathan Campus N48 2.14, 170 Kessels Road, Nathan, Brisbane, 4111, QLD, Australia; School of Health Sciences, City, University of London, Northampton Square, London, EC1V 0HB, United Kingdom. Electronic address: leanne.aitken.1@city.ac.uk.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2020.01.002']
3154,32114586,Effects of Edaravone on Neurological Function and Tumor Necrosis Factor Alpha and Interleukin 8 Levels in Patients with Cerebral Infarction.,"OBJECTIVE
The present study aimed to explore the effects of edaravone on neurological function, tumor necrosis factor α (TNF-α), and interleukin (IL)-8 levels in patients with cerebral infarction.
METHODS
A total of 96 patients with cerebral -infarction who were admitted to the department of neurology in our hospital were enrolled in the present study, and they were randomly assigned to Group A (n = 48) and Group B (n = 48). Group A was treated with conventional therapy plus edaravone for 2 weeks and Group B with conventional therapy alone for 2 weeks. Enzyme-linked immunosorbent assay was used to determine serum TNF-α and IL-8 levels before and after treatment, and Pearson correlation analysis was conducted to analyze the correlation between serum TNF-α and IL-8 levels as well as National Institutes of Health Stroke Scale (NIHSS) score.
RESULTS
After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05). In addition, after treatment, no significant differences were observed between the 2 groups in terms of the presence of adverse reactions (p > 0.05). Pearson correlation analysis revealed a significant positive correlation between serum TNF-α and IL-8 levels as well as NIHSS score (r = -0.567 and r = -0.556, both p < 0.05).
CONCLUSION
Edaravone can improve the neurological function of patients without causing evident adverse reactions, thereby improving quality of life, which may be correlated to decreased serum TNF-α and IL-8 levels.",2020,"After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05).","['Patients with Cerebral Infarction', '96 patients with cerebral -infarction who were admitted to the department of neurology in our hospital were enrolled in the present study', 'patients with cerebral infarction']","['conventional therapy plus edaravone', 'edaravone', 'Edaravone']","['serum TNF-α and IL-8 levels as well as National Institutes of Health Stroke Scale (NIHSS) score', 'Neurological Function and Tumor Necrosis Factor Alpha and Interleukin 8 Levels', 'NIHSS score', 'higher activities of daily living score', 'lower NIHSS score and serum TNF-α and IL-8 levels', 'presence of adverse reactions', 'quality of life', 'serum TNF-α and IL-8 levels', 'neurological function', 'neurological function, tumor necrosis factor α (TNF-α), and interleukin (IL)-8 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027767', 'cui_str': 'Nervous System Physiology'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",96.0,0.0377349,"After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05).","[{'ForeName': 'Xiushan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of Hebei University of Engineering, Handan, China.'}, {'ForeName': 'Dongzhou', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of Hebei University of Engineering, Handan, China.'}, {'ForeName': 'Guozhu', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang, China, gzzzs2@163.com.'}]",European neurology,['10.1159/000505776']
3155,32076607,Outcome of Gynecologic Laparoendoscopic Single-Site Surgery with a Homemade Device and Conventional Laparoscopic Instruments in a Chinese Teaching Hospital.,"Objective
To demonstrate various benign gynecologic diseases that can be performed by laparoendoscopic single-site surgery (LESS) with conventional laparoscopic instruments.
Method
Patients with benign gynecologic diseases that need ovarian cystectomy, fallopian tube resection, or myomectomy were divided into experimental group and control group, and perioperative outcomes of these patients were analyzed.
Results
From November 2017 to May 2018, 65 LESS gynecological surgeries were performed, among which there were 25 ovarian cystectomies, 28 unilateral fallopian tube resections, and 12 myomectomies. All the surgeries were completed smoothly, and only one surgery needed one more additional port. No patients have severe complications. Operative time, intraoperative blood loss, and perioperative complications have no difference between the two groups. The LESS laparoscopy group had less postoperative pain scores and longer bowel recovering time, compared with the conventional laparoscopy group (<0.05).
Conclusion
Compared with traditional laparoscopy, LESS surgery with conventional laparoscopic instruments is feasible and safe, but postoperative exhaust time is longer than the control group.",2020,"The LESS laparoscopy group had less postoperative pain scores and longer bowel recovering time, compared with the conventional laparoscopy group (<0.05).
","['65 LESS gynecological surgeries were performed, among which there were 25 ovarian cystectomies, 28 unilateral fallopian tube resections, and 12 myomectomies', 'Method\n\n\nPatients with benign gynecologic diseases that need ovarian cystectomy, fallopian tube resection, or myomectomy', 'a Chinese Teaching Hospital']","['traditional laparoscopy, LESS surgery with conventional laparoscopic instruments', 'conventional laparoscopy', 'Gynecologic Laparoendoscopic Single-Site Surgery with a Homemade Device and Conventional Laparoscopic Instruments', 'laparoendoscopic single-site surgery (LESS) with conventional laparoscopic instruments']","['postoperative pain scores and longer bowel recovering time', 'severe complications', 'postoperative exhaust time', 'Operative time, intraoperative blood loss, and perioperative complications']","[{'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0010651', 'cui_str': 'Cystectomy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4255212', 'cui_str': 'Myomectomy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0017411', 'cui_str': 'Gynecologic Diseases'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0195488', 'cui_str': 'Removal of ovarian cyst (procedure)'}, {'cui': 'C0195309', 'cui_str': 'Uterine Myomectomy'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0231226', 'cui_str': 'Exhausting (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}]",28.0,0.070637,"The LESS laparoscopy group had less postoperative pain scores and longer bowel recovering time, compared with the conventional laparoscopy group (<0.05).
","[{'ForeName': 'Xianghui', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': ""Department of Minimal Invasive Gynecology, Guangzhou Women and Children's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': ""Department of Minimal Invasive Gynecology, Guangzhou Women and Children's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Canliang', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': ""Department of Minimal Invasive Gynecology, Guangzhou Women and Children's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Department of Minimal Invasive Gynecology, Guangzhou Women and Children's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Chunfang', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': ""Department of Minimal Invasive Gynecology, Guangzhou Women and Children's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Zhuohui', 'Initials': 'Z', 'LastName': 'Zhong', 'Affiliation': ""Department of Minimal Invasive Gynecology, Guangzhou Women and Children's Hospital, Guangzhou Medical University, Guangzhou, China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ""Department of Minimal Invasive Gynecology, Guangzhou Women and Children's Hospital, Guangzhou Medical University, Guangzhou, China.""}]",BioMed research international,['10.1155/2020/5373927']
3156,32077134,"Effects, costs and implementation of monitoring kidney transplant patients' tacrolimus levels with dried blood spot sampling: A randomized controlled hybrid implementation trial.","AIMS
Dried blood spot (DBS) home sampling allows monitoring creatinine levels and tacrolimus trough levels as an alternative for blood sampling in the hospital, which is important in kidney transplant patient follow-up. This study aims to assess whether DBS home sampling results in decreased patient travel burden and lower societal costs.
METHODS
In this single-centre randomized controlled hybrid implementation trial, adult kidney transplant patients were enrolled. The intervention group (n = 25) used DBS home sampling on top of usual care in the first 6 months after transplantation. The control group (n = 23) received usual care only. The primary endpoint was the number of outpatient visits. Other endpoints were costs per patient, patient satisfaction and implementation.
RESULTS
There was no statistically significant difference in the average number of outpatient visits between the DBS group (11.2, standard deviation: 1.7) and the control group (10.9, standard deviation: 1.4; P = .48). Average costs per visit in the DBS group were not significantly different (€542, 95% confidence interval €316-990) compared to the control group (€533, 95% confidence interval €278-1093; P = .66). Most patients (n = 19/23, 82.6%) were willing to perform DBS home-sampling if this would reduce the number of hospital visits. Only 55.9% (n = 143/256) of the expected DBS samples were received and 1/5 analysed on time (n = 52/256).
CONCLUSION
Adult kidney transplant patients are willing to perform DBS home sampling. However, to decrease patient travel burden and costs in post-transplant care, optimization of the logistical process concerning mailing and analysis of DBS samples is crucial.",2020,"Average costs per visit in the DBS group were not significantly different (€542, 95%CI €","['Adult kidney transplant patients', 'adult kidney transplant patients were enrolled', ""kidney transplant patients' tacrolimus levels with Dried Blood Spot sampling""]","['Dried Blood Spot (DBS', 'usual care only', 'DBS home sampling']","['average number of outpatient visits', 'costs per patient (2) patient satisfaction and (3) implementation', 'patient travel burden and lower societal costs', 'number of outpatient visits', 'Average costs per visit', 'number of hospital visits']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.114818,"Average costs per visit in the DBS group were not significantly different (€542, 95%CI €","[{'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Veenhof', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Job Frank Martien', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'van der Voort', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stefan Philip', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stephanus Johannes Leonardus', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daniël Johannes', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14249']
3157,32115470,The Effect of Dapagliflozin Treatment on Epicardial Adipose Tissue Volume and P-Wave Indices: An Ad-hoc Analysis of The Previous Randomized Clinical Trial.,"AIM
Epicardial adipose tissue (EAT) may be associated with arrhythmogenesis. P-wave indices such as P-wave dispersion and P-wave variation indicated a slowed conduction velocity within the atria. This study investigated the effect of dapagliflozin on EAT volume and P-wave indices.
METHODS
In the present ad hoc analysis, 35 patients with type 2 diabetes mellitus and coronary artery disease were classified into dapagliflozin group (n=18) and conventional treatment group (n=17). At baseline, EAT volume, HbA1c and plasma level of tumor necrotic factor-α (TNF-α) levels, echocardiography, and 12-lead electrocardiogram (ECG) were performed. EAT volume was measured using computed tomography. Using 12-lead ECG, P-wave indices were measured.
RESULTS
At baseline, EAT volumes in the dapagliflozin and conventional treatment groups were 113±20 and 110±27 cm 3 , respectively. Not only HbA1c and plasma level of TNF-α but also echocardiography findings including left atrial dimension and P-wave indices were comparable between the two groups. After 6 months, plasma level of TNF-α as well as EAT volume significantly decreased in the dapagliflozin group only. P-wave dispersion and P-wave variation significantly decreased in the dapagliflozin group only (-9.2±8.7 vs. 5.9±19.9 ms, p=0.01; -3.5±3.5 vs. 1.7±5.9 ms, p=0.01). The change in P-wave dispersion correlated with changes in EAT volume and plasma level of TNF-α. In multivariate analysis, the change in EAT volume was an independent determinant of the change in P-wave dispersion.
CONCLUSION
Dapagliflozin reduced plasma level of TNF-α, EAT volume, and P-wave indices, such as P-wave dispersion. The changes in P-wave indices were especially associated with changes in EAT volume.The number and date of registration: UMIN000035660, 24/Jan/2019.",2020,P-wave indices such as P-wave dispersion and P-wave variation indicated a slowed conduction velocity within the atria.,['35 patients with type 2 diabetes mellitus and coronary artery disease were classified into dapagliflozin group (n=18) and conventional treatment group (n=17'],"['Epicardial adipose tissue (EAT', 'Dapagliflozin', 'dapagliflozin']","['plasma level of TNF-α as well as EAT volume', 'number and date of registration', 'conduction velocity', 'EAT volume and P-wave indices', 'EAT volume, HbA1c and plasma level of tumor necrotic factor-α (TNF-α) levels, echocardiography, and 12-lead electrocardiogram (ECG', 'EAT volumes', 'EAT volume and plasma level of TNF-α', 'Epicardial Adipose Tissue Volume and P-Wave Indices', 'EAT volume', 'plasma level of TNF-α, EAT volume, and P-wave indices, such as P-wave dispersion', 'HbA1c and plasma level of TNF-α', 'change in EAT volume']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0234084', 'cui_str': 'Conduction rate of nerve cell and nerve fiber, function (observable entity)'}, {'cui': 'C0429084', 'cui_str': 'P wave feature'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",35.0,0.0528382,P-wave indices such as P-wave dispersion and P-wave variation indicated a slowed conduction velocity within the atria.,"[{'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Cardiology, Tachikawa General Hospital.'}, {'ForeName': 'Yoshifusa', 'Initials': 'Y', 'LastName': 'Aizawa', 'Affiliation': 'Cardiology, Tachikawa General Hospital.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Yuasa', 'Affiliation': 'Cardiology, Tachikawa General Hospital.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Cardiology, Tachikawa General Hospital.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Cardiology, Tachikawa General Hospital.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Okabe', 'Affiliation': 'Cardiology, Tachikawa General Hospital.'}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.48009']
3158,32090748,Glycyrrhizic acid as an adjunctive treatment for depression through anti-inflammation: A randomized placebo-controlled clinical trial.,"BACKGROUND
Recently, abundant evidence indicated proinflammatory cytokines might play a crucial role in pathophysiology and treatment of depression. According to our preclinical research, we propose glycyrrhizic acid (GZA) for an adjunctive treatment owing to its safety, economical and anti-inflammatory profile.
METHODS
Eligible participants were recruited and randomly allocated into independent treatment groups of SSRI+GZA (n = 30) and SSRI+PBO (placebo, n = 26). Depressive symptoms and specific serum biomarkers were detected during the 4-week treatment course. Afterward, the relationships between biomarkers and clinical effects were explored.
RESULTS
Depressive symptoms relieved more in SSRI+GZA than SSRI+PBO, both at week 2 (P = 0.003) and week 4 (P = 0.016). Meanwhile, at week 4, both response rate (P = 0.035) and remission rate (P = 0.031) acutely became higher in SSRI+GZA compared with SSRI+PBO. Mediation analysis further demonstrated that TNF-α reduction mediated the association between GZA treatment and clinical improvement, the indirect effect lay between 0.124 and 3.514 (95% CI). The exploratory analysis also suggested that the symptomatic improvement existed in patients with high-inflammation (baseline CRP > 3 mg/L) rather than those with low-inflammation (baseline CRP ≤ 3 mg/L).
LIMITATIONS
The sample size in this study was not large enough and the follow-up duration was relatively short.
CONCLUSIONS
This study offers a novel strategy for the diagnosis, categorization, individualization and prognosis regarding upgrading traditional antidepressant therapy, which is from biomarkers to diagnostic indicator and therapeutic target. Patients are necessary to be classified according to the inflammatory state, those with high levels of baseline inflammation should receive combined treatment with anti-inflammatory agents like GZA.",2020,"Meanwhile, at week 4, both response rate (P = 0.035) and remission rate (P = 0.031) acutely became higher in SSRI+GZA compared with SSRI+PBO.","['depression through anti-inflammation', 'Eligible participants']","['SSRI+PBO (placebo', 'glycyrrhizic acid (GZA', 'Glycyrrhizic acid', 'placebo', 'SSRI+GZA', 'anti-inflammatory agents like GZA']","['Depressive symptoms and specific serum biomarkers', 'response rate', 'Depressive symptoms', 'remission rate']","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061751', 'cui_str': 'glycyrrhizin'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatories'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.159878,"Meanwhile, at week 4, both response rate (P = 0.035) and remission rate (P = 0.031) acutely became higher in SSRI+GZA compared with SSRI+PBO.","[{'ForeName': 'Zhi-Yong', 'Initials': 'ZY', 'LastName': 'Cao', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China; Department of Psychiatry, The 904th Hospital of PLA, 55 North Heping Road, Changzhou, China.'}, {'ForeName': 'Yun-Zi', 'Initials': 'YZ', 'LastName': 'Liu', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Jia-Mei', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Ruan', 'Affiliation': 'Department of Health Statistics, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Wen-Jie', 'Initials': 'WJ', 'LastName': 'Yan', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Shi-Yang', 'Initials': 'SY', 'LastName': 'Zhong', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Lin-Lin', 'Initials': 'LL', 'LastName': 'Liu', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China; Department of Nursing, The 474th Hospital of PLA, 757 Beijing Road, Urumqi, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Xiao-Ying', 'Initials': 'XY', 'LastName': 'Bi', 'Affiliation': 'Department of Neurology, Changhai Hospital, 168 Changhai Road, Shanghai, China.'}, {'ForeName': 'Yun-Xia', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China.'}, {'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Su', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China. Electronic address: suwenjun1992@163.com.'}, {'ForeName': 'Chun-Lei', 'Initials': 'CL', 'LastName': 'Jiang', 'Affiliation': 'Department of Stress Medicine, Faculty of Psychology, Second Military Medical University, 800 Xiangyin Road, Shanghai, China. Electronic address: cljiang@vip.163.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.048']
3159,32090766,Factors associated with engagement in online self-help programs among people with suicidal thoughts.,"BACKGROUND
The effectiveness of internet-based self-help programs for mental health may be limited by low engagement. Identifying factors associated with engagement in online interventions assists in developing strategies to improve efficacy through greater engagement. The aim of the current study was to identify factors associated with engagement among people with suicidal thoughts who completed an online program.
METHOD
418 adults with suicidal ideation were recruited online into a randomized controlled trial of a 6-week internet-based self-help program. Program usage for the intervention and active control conditions was measured as the number of logins and modules accessed. Predictors of program usage and between-group differences were examined, including sociodemographic variables, user preferences and mental health status.
RESULTS
Both the control group and the intervention group accessed approximately three modules (M = 3.1, SD = 2.0 v. M = 2.8, SD = 2.1, respectively), although participants in the intervention group had a significantly higher number of logins (17.3 vs 9.7, p < 0.001). Across both conditions, individuals with more severe suicidal thoughts had better engagement with their respective program. More logins for both programs were also associated with being female, married or in a de-facto relationship, not employed, less severe depression and less willingness to seek help from informal sources.
LIMITATIONS
Metrics of adherence may not directly reflect engagement with the program. There may be additional unmeasured factors associated with engagement.
CONCLUSIONS
The findings suggest that different engagement strategies may be required depending on sociodemographic and clinical characteristics. Tailoring interventions to at-risk subgroups may optimise health and functional outcomes.",2020,"More logins for both programs were also associated with being female, married or in a de-facto relationship, not employed, less severe depression and less willingness to seek help from informal sources.
","['people with suicidal thoughts who completed an online program', 'people with suicidal thoughts', '418 adults with suicidal ideation']",['6-week internet-based self-help program'],"['number of logins', 'sociodemographic variables, user preferences and mental health status']","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",418.0,0.0695005,"More logins for both programs were also associated with being female, married or in a de-facto relationship, not employed, less severe depression and less willingness to seek help from informal sources.
","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Batterham', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia. Electronic address: philip.batterham@anu.edu.au.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Mackinnon', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Werner-Seidler', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Calear', 'Affiliation': 'Centre for Mental Health Research, Research School of Population Health, The Australian National University, Canberra, Australia.'}, {'ForeName': 'Quincy', 'Initials': 'Q', 'LastName': 'Wong', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia; Western Sydney University, Sydney, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Torok', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Christensen', 'Affiliation': 'Black Dog Institute, University of New South Wales, Sydney, Australia.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.044']
3160,32090767,The accuracy of depression risk perception in high risk Canadians.,"BACKGROUND
Prevention and early detection of depression is a top public health priority. Accurate perception of depression risk may play an important role in health behavior change and prevention of depression. However, the way in which people in the community perceive their risk of developing depression is currently unknown.
METHODS
We analyzed the baseline data from a randomized controlled trial in 358 men and 356 women who are at high risk of having a major depressive episode (MDE). The predicted risk was assessed by sex-specific multivariable risk predictive algorithms for MDE. We compared participants' perceived risk and their predicted risk. Accurate risk perception was defined as perceived risk is in the range of predicted risk ± 10%.
RESULTS
In men, 29.7% perceived their risk accurately; 47.5% overestimated their risk; 22.8% underestimated their risk. In women, the proportions were 21.7%, 59.6% and 18.7%, respectively. Compared to men, women were more likely to overestimate their risk and less likely to be accurate. Regression modeling revealed that poor self-rated health and higher predicted depression risk were associated with inaccuracy of risk perception in men; a family history of MDE, higher psychological distress and lower predicted risk were associated with inaccuracy of risk perception in women.
CONCLUSIONS
Individuals who are at high risk of developing depression tend to overestimate their risk, especially women. Inaccurate depression risk perception is related to people's health status. Educational interventions are needed to enhance the accuracy of risk perception to encourage positive behavior change and uptake of preventive strategies.",2020,"Regression modeling revealed that poor self-rated health and higher predicted depression risk were associated with inaccuracy of risk perception in men; a family history of MDE, higher psychological distress and lower predicted risk were associated with inaccuracy of risk perception in women.
","['high risk Canadians', '358 men and 356 women who are at high risk of having a major depressive episode (MDE']",[],"['Accurate risk perception', 'Inaccurate depression risk perception', 'accuracy of depression risk perception']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]",[],"[{'cui': 'C0443131', 'cui_str': 'Accurate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443236', 'cui_str': 'Inaccurate (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",358.0,0.0515085,"Regression modeling revealed that poor self-rated health and higher predicted depression risk were associated with inaccuracy of risk perception in men; a family history of MDE, higher psychological distress and lower predicted risk were associated with inaccuracy of risk perception in women.
","[{'ForeName': 'JianLi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada. Electronic address: jianli.wang@theroyal.ca.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Smail-Crevier', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Nannarone', 'Affiliation': 'The Institute of Mental Health Research, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Manuel', 'Affiliation': 'School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; Department of Family Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'MacQueen', 'Affiliation': 'Department of Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Patten', 'Affiliation': 'Department of Psychiatry, Cumming School of Medicine, University of Calgary, Calgary, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Lashewicz', 'Affiliation': 'Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, McGill University, Montreal, Canada.'}]",Journal of affective disorders,['10.1016/j.jad.2020.01.099']
3161,32098012,The immunosuppressive effects of volatile versus intravenous anesthesia combined with epidural analgesia on kidney cancer: a pilot randomized controlled trial.,"BACKGROUND
The aim of this study was to test the hypothesis that the use of inhalational anesthesia leads to higher suppression of the cell-mediated immunity compared to total intravenous anesthesia in patients undergoing kidney cancer surgery under combined low thoracic epidural analgesia and general anesthesia.
METHODS
Patients were randomly allocated to either propofol-based (intravenous anesthetic) or sevoflurane-based (volatile anesthetic) anesthesia group with 10 patients in each group, along with epidural analgesia in both groups. Amounts of natural killer (NK) cells, total T lymphocytes, and T lymphocyte subpopulations in the blood samples collected from the patients before surgery, at the end of the surgery and postoperative days 1, 3 and 7 were determined by flow cytometric analysis. The NK cell count served as the primary endpoint of the study, whereas the total T lymphocyte count and cell counts for T lymphocyte subpopulations were used as the secondary endpoint.
RESULTS
Our study showed that there were no significant differences in the amount of NK cells, total T lymphocytes, regulatory T cells, and T-helper cells, cytotoxic T lymphocytes, and their subpopulations between the propofol- and sevoflurane-based anesthesia groups when the anesthesia was administered in combination with epidural analgesia.
CONCLUSIONS
The results of this pilot study did not support the hypothesis that the use of inhalational anesthesia leads to higher suppression of the cell-mediated immunity than that of total intravenous anesthesia in patients undergoing kidney cancer surgery under combined low thoracic epidural analgesia and general anesthesia.",2020,"Our study showed that there were no significant differences in the frequency of NK cells, total T lymphocytes, regulatory T cells, and T-helper cells, cytotoxic T lymphocytes, and their subpopulations between the propofol-based and sevoflurane-based anesthesia group, when the anesthesia was administered in combination with epidural analgesia.
","['kidney cancer', 'patients undergoing kidney cancer surgery under combined low thoracic epidural analgesia and general anesthesia']","['volatile versus intravenous anesthesia combined with epidural analgesia', 'propofol-based (intravenous anesthetic) or sevoflurane-based (volatile anesthetic) anesthesia', 'inhalational anesthesia']","['natural killer (NK) cell count', 'Frequencies of natural killer cells, total T lymphocytes, and T lymphocyte subpopulations', 'frequency of NK cells, total T lymphocytes, regulatory T cells, and T-helper cells, cytotoxic T lymphocytes, and their subpopulations', 'total T lymphocyte count and cell counts for T lymphocyte subpopulations']","[{'cui': 'C0740457', 'cui_str': 'Cancer of Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C1963547', 'cui_str': 'Volatile'}, {'cui': 'C0002920', 'cui_str': 'Anesthesia, Intravenous'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242904', 'cui_str': 'Anesthetics, Intravenous'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C2363836', 'cui_str': 'NK cell count'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0018894', 'cui_str': 'T-Lymphocytes, Helper'}, {'cui': 'C0039195', 'cui_str': 'Cell-Mediated Lympholytic Cells'}, {'cui': 'C1271588', 'cui_str': 'Total T lymphocyte count'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}]",,0.0478835,"Our study showed that there were no significant differences in the frequency of NK cells, total T lymphocytes, regulatory T cells, and T-helper cells, cytotoxic T lymphocytes, and their subpopulations between the propofol-based and sevoflurane-based anesthesia group, when the anesthesia was administered in combination with epidural analgesia.
","[{'ForeName': 'Sergey Mihailovich', 'Initials': 'SM', 'LastName': 'Efremov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Saint Petersburg State University Hospital, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Victoria Sergeevna', 'Initials': 'VS', 'LastName': 'Kozireva', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Gleb Borisovich', 'Initials': 'GB', 'LastName': 'Moroz', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Marat Nikolaevich', 'Initials': 'MN', 'LastName': 'Abubakirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Olga Sergeevna', 'Initials': 'OS', 'LastName': 'Shkoda', 'Affiliation': 'Department of Laboratory Diagnostics, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Anna Nikolaevna', 'Initials': 'AN', 'LastName': 'Shilova', 'Affiliation': 'Department of Laboratory Diagnostics, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Sergey Valeriyevich', 'Initials': 'SV', 'LastName': 'Yarmoshuk', 'Affiliation': 'Department of Oncology, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexandr Alexandrovich', 'Initials': 'AA', 'LastName': 'Zheravin', 'Affiliation': 'Department of Oncology, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Vladimir Vladimirovich', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russian Federation.'}]",Korean journal of anesthesiology,['10.4097/kja.19461']
3162,32118696,Chronic Exposure to Low-Dose Carbon Monoxide Alters Hemoglobin Mass and V˙O2max.,"By blocking the oxygen binding sites on the hemoglobin molecule, chronic low-dose carbon monoxide (CO) administration may produce similar effects to those of exposure to altitude.
PURPOSE
This study aimed to determine the effect of chronic low-dose CO application on hemoglobin mass (Hbmass) and V˙O2max.
METHODS
For 3 wk, 11 healthy and moderately trained male subjects inhaled a CO bolus five times per day to increase their HbCO concentration by ~5%. Another 11 subjects received a placebo. Hbmass, serum erythropoietin concentration, ferritin, and basic hematological parameters were determined before and weekly during and until 3 wk after the CO inhalation period. V˙O2max tests on a cycle ergometer were performed before and after the CO administration period.
RESULTS
In the CO group, Hbmass increased from 919 ± 69 to 962 ± 78 g in week 3 (P < 0.001) and was maintained for the following 3 wk. Reticulocytes (%) and immature reticulocyte fraction significantly increased after 1 wk. Serum erythropoietin concentration tended to increase after 1 wk (P = 0.07) and was suppressed in the postperiod (P < 0.01). Ferritin decreased during the inhalation period (from 106 ± 37 to 72 ± 37 ng·mL, P < 0.001). V˙O2max tended to increase from 4230 ± 280 to 4350 ± 350 mL·min (P < 0.1) immediately after the inhalation period and showed a significant relationship to the change in Hbmass (y = 4.1x - 73.4, r = 0.70, P < 0.001).
CONCLUSIONS
Chronic continuous exposure to low-dose CO enhances erythropoietic processes resulting in a 4.8% increase in Hbmass. The individual changes in Hbmass were correlated to the corresponding changes in V˙O2max. Examination of ethical and safety concerns is warranted before the implementation of low-dose CO inhalation in the clinical/athletic setting as a tool for modifying Hbmass.",2020,[EPO] tended to increase after one week (p=0.07) and was suppressed in the post period (p<0.01).,[],"['placebo', 'EPO', 'chronic low dose CO-application']","['hemoglobin mass (Hbmass) and VO2max', 'Reticulocytes (%) and IRF', 'HbCO concentration', 'VO2max', 'Ferritin', 'Hbmass, serum erythropoietin concentration [EPO], ferritin, and basic hematological parameters']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0035286', 'cui_str': 'Reticulocytes'}, {'cui': 'C1446165', 'cui_str': 'Immature reticulocyte fraction'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",11.0,0.0165678,[EPO] tended to increase after one week (p=0.07) and was suppressed in the post period (p<0.01).,"[{'ForeName': 'Walter F J', 'Initials': 'WFJ', 'LastName': 'Schmidt', 'Affiliation': '1Department of Sports Medicine/Sports Physiology, University of Bayreuth, GERMANY 2Institute of Doping Analysis und Sports Biochemistry, University of Dresden, GERMANY 3Department of Integrative Physiology, University of Colorado, Boulder, CO.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hoffmeister', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Haupt', 'Affiliation': ''}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schwenke', 'Affiliation': ''}, {'ForeName': 'Nadine B', 'Initials': 'NB', 'LastName': 'Wachsmuth', 'Affiliation': ''}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Byrnes', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002330']
3163,32032809,Hysteroscopic Assessment of Tubal Patency: A Randomized Comparison between the Flow and Parryscope Techniques.,"STUDY OBJECTIVE
To evaluate the accuracy of the ""Parryscope"" and ""flow"" techniques for hysteroscopic assessment of tubal patency.
DESIGN
Prospective randomized clinical trial.
SETTING
From May to October 2019, women with subfertility undergoing laparoscopic and hysteroscopic surgery at the Medical University of Vienna were invited to participate in the study. The primary outcome was accuracy of Fallopian tube patency relative to the gold standard of laparoscopic chromopertubation.
PATIENTS
Sixty women with subfertility.
INTERVENTIONS
Hysteroscopy with either the ""Parryscope"" or the ""flow"" techniques for tubal assessment, directly followed by laparoscopy with chromopertubation.
MEASUREMENTS AND MAIN RESULTS
Hysteroscopic prediction of fallopian tube patency was possible in a statistically significant manner in both study groups (p <0.05). The Parryscope technique achieved higher sensitivity (90.6%, 95% CI: 61.7-98.4) and specificity (100%, 95% CI: 90.0-100.0) than the flow technique (sensitivity: 73.7%, 95% CI: 48.8-90.9 and specificity: 70.7%, 95% CI: 54.5-83.9).
CONCLUSION
Using the Parryscope technique to determine if air bubbles traverse the ostia can provide valuable additional information during hysteroscopy and is more accurate in predicting fallopian tubal occlusion than the flow method.",2020,Hysteroscopic prediction of Fallopian tube patency was possible in a statistically significant manner in both study groups (p< 0.05).,"['60 subfertile women', 'From May to October, 2019, subfertile women undergoing laparoscopic and hysteroscopic surgery at the Medical University of Vienna were invited to participate in the study']","['Hysteroscopy with either the ""Parryscope®"" or the ""flow"" techniques', 'Parryscope®"" and ""flow"" techniques']","['Fallopian tubal occlusion', 'Hysteroscopic Assessment of tubal patency', 'higher sensitivity', 'Hysteroscopic prediction of Fallopian tube patency', 'accuracy of Fallopian tube patency relative to the gold standard of laparoscopic chromopertubation', 'specificity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0751614', 'cui_str': 'Hysteroscopic Surgical Procedures'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0041275', 'cui_str': 'Tubal Occlusion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3160762', 'cui_str': 'Chromopertubation'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",,0.0788059,Hysteroscopic prediction of Fallopian tube patency was possible in a statistically significant manner in both study groups (p< 0.05).,"[{'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Hager', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz).'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ott', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz). Electronic address: johannes.ott@meduniwien.ac.at.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Holzer', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz).'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Seemann', 'Affiliation': 'Department of Oral and Maxillofacial Surgery (Dr. Seemann), Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Kurz', 'Affiliation': 'Clinical Division of Gynecological Endocrinology and Reproductive Medicine (Drs. Hager, Ott, Holzer, and Kurz).'}, {'ForeName': 'John Preston', 'Initials': 'JP', 'LastName': 'Parry', 'Affiliation': 'Parryscope and Positive Steps Fertility, Madison; Department of Obstetrics and Gynecology, University of Mississippi Medical Center (Dr. Parry), Jackson, Mississippi.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.01.014']
3164,32102059,Does Mental Fatigue Negatively Affect Outcomes of Functional Performance Tests?,"PURPOSE
Mental fatigue impairs psychomotor skill performance by affecting visuomotor reaction time, accuracy, and decision-making. Recently, neurocognitive functional performance tests (FPT) that integrate these outcomes have been developed. The aim of this study was to assess the effect of mental fatigue on traditional and neurocognitive FPT in healthy adults.
METHODS
Fourteen volunteers (four women; mean ± SD age, 22 ± 1 yr; height, 176.9 ± 8.4 cm; weight, 69.7 ± 10.4 kg) participated in a randomized counterbalanced crossover design. A 100% incongruent Stroop color word test of 90 min was used to induce mental fatigue and the control task encompassed watching a 90-min documentary. Traditional FPT comprised a single-leg hop for distance, countermovement jump, and Y-balance test, whereas the neurocognitive FPT encompassed the reactive balance test (RBT). All FPTs were evaluated pre-post the 90-min task. Mental fatigue was assessed using the Stroop task, visual analog scale for mental fatigue, and the Eriksen-Flanker task.
RESULTS
Mental fatigue was successfully induced, as shown by a significant increase in visual analog scale for mental fatigue (P < 0.001), with no decrease in performance on the Stroop and Eriksen-Flanker task. No interaction effect of mental fatigue was found for the Y-balance test, single-leg hop, and countermovement jump. For the RBT accuracy, a significant interaction effect of mental fatigue and time was observed (P = 0.024), with participants performing significantly worse when mentally fatigued. No interaction effect or main effect of condition and time was observed when considering the effect of mental fatigue on visuomotor reaction time in the RBT.
CONCLUSIONS
Mental fatigue negatively affects a neurocognitive FPT, indicated by a decreased accuracy in response to visual stimuli in the RBT. Traditional FPT remained unaffected by mental fatigue.",2020,"RESULTS
Mental fatigue was successfully induced, as shown by a significant increase in M-VAS (p<0.001), with no decrease in performance on the Stroop and Eriksen-Flanker task.","['Fourteen volunteers (four women; mean ± SD; age = 22 ± 1 years; height = 176.9 ± 8.4 cm; weight = 69.7 ± 10.4 kg', 'healthy adults']",[],"['reactive balance test (RBT', 'Mental fatigue', 'mental fatigue', 'Stroop task, M-VAS scale and the Eriksen-Flanker task', 'visuomotor reaction time, accuracy and decision-making', 'distance (SLH), countermovement jump (CMJ) and Y-balance test (YBT', 'visuomotor reaction time', 'M-VAS', 'performance on the Stroop and Eriksen-Flanker task', 'mental fatigue and time']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]",[],"[{'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0222045'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",14.0,0.0468719,"RESULTS
Mental fatigue was successfully induced, as shown by a significant increase in M-VAS (p<0.001), with no decrease in performance on the Stroop and Eriksen-Flanker task.","[{'ForeName': 'J O', 'Initials': 'JO', 'LastName': 'Verschueren', 'Affiliation': ""1Faculty of Physical Education and Physiotherapy, Human Physiology and Sports Physiotherapy Research Group, Vrije Universiteit Brussel, Brussels, BELGIUM 2Amsterdam Collaboration on Health and Safety in Sports, Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Movement Sciences, Amsterdam, the NETHERLANDS 3Strategic Research Program 'Exercise and the Brain in Health & Disease: the added value of Human-Centered Robotics,' Vrije Universiteit Brussel, Brussels, BELGIUM.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Tassignon', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Proost', 'Affiliation': ''}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Teugels', 'Affiliation': ''}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'VAN Cutsem', 'Affiliation': ''}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Roelands', 'Affiliation': ''}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': ''}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Meeusen', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002323']
3165,32093709,Forum theater staging of difficult encounters with patients to increase empathy in students: evaluation of efficacy at The University of Angers Medical School.,"BACKGROUND
Physician empathy has been associated with improved clinical outcomes and lower physician burnout. We evaluated whether forum theater (FT), a form of applied drama that allows participants to enter the performance and represent the actions associated with emotions, would foster empathy in medical students, and which underlying variables would be associated to empathy scores.
METHODS
Three classes totaling 488 fourth-year medical students participated in the study. Forum theater was used to explore difficult encounters with patients and family members: announcement of cancer, fall at home of an elderly person requiring hospitalization, appointment with a patient suffering from depression, announcement of diabetes in an adolescent. The first scene was played by actors in front of a group of students, then audience members were asked to enter the performance and, by taking over the role of the ""physician-actor,"" to explore alternative interactions. All the students followed two sessions as actors and observers in random order and were randomly assigned to FT sessions after 36 or 56 weeks of clinical rotations. They completed the Jefferson Scale of Physician Empathy (JFSE) anonymously.
RESULTS
Students were 22.1 ± 1.5 years old (43% males). Empathy scores increased after each session: 102.0 ± 9.8 before the sessions, 106.3 ± 9.8 after session 1 and 107.8 ± 11.5 after session 2 (p < 0.05). In regression models, gender (F vs. M, + 3.0 ± 1.0, p < 0.001) and position in the session (actor vs. observer, + 2.1 ± 1.0, p < 0.05) were significant determinants of JFSE scores, whereas age, session theme, and duration of clinical rotation were not.
CONCLUSION
Being an actor in forum theater was a valuable tool for enhancing empathy scores in medical students.",2020,"In regression models, gender (F vs. M, + 3.0 ± 1.0, p < 0.001) and position in the session (actor vs. observer, + 2.1 ± 1.0, p < 0.05) were significant determinants of JFSE scores, whereas age, session theme, and duration of clinical rotation were not.
","['Students were 22.1\u2009±\u20091.5\u2009years old (43% males', 'Three classes totaling 488 fourth-year medical students participated in the study', 'medical students', 'encounters with patients and family members: announcement of cancer, fall at home of an elderly person requiring hospitalization, appointment with a patient suffering from depression, announcement of diabetes in an adolescent']",[],"['Jefferson Scale of Physician Empathy (JFSE) anonymously', 'duration of clinical rotation', 'Empathy scores', 'JFSE scores']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],"[{'cui': 'C0222045'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0170915,"In regression models, gender (F vs. M, + 3.0 ± 1.0, p < 0.001) and position in the session (actor vs. observer, + 2.1 ± 1.0, p < 0.05) were significant determinants of JFSE scores, whereas age, session theme, and duration of clinical rotation were not.
","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Sevrain-Goideau', 'Affiliation': 'Department of Pediatrics, University Hospital, 4 rue Larrey, 49000, Angers, France.'}, {'ForeName': 'Benedicte', 'Initials': 'B', 'LastName': 'Gohier', 'Affiliation': 'Department of Psychiatry, University Hospital, Angers, France.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Bellanger', 'Affiliation': 'Medical School, University of Angers, Angers, France.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Annweiler', 'Affiliation': 'Medical School, University of Angers, Angers, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'Medical School, University of Angers, Angers, France.'}, {'ForeName': 'Regis', 'Initials': 'R', 'LastName': 'Coutant', 'Affiliation': 'Department of Pediatrics, University Hospital, 4 rue Larrey, 49000, Angers, France. recoutant@chu-angers.fr.'}]",BMC medical education,['10.1186/s12909-020-1965-4']
3166,32070353,Simulation-based mastery learning compared to standard education for discussing diagnostic uncertainty with patients in the emergency department: a randomized controlled trial.,"BACKGROUND
Diagnostic uncertainty occurs frequently in emergency medical care, with more than one-third of patients leaving the emergency department (ED) without a clear diagnosis. Despite this frequency, ED providers are not adequately trained on how to discuss diagnostic uncertainty with these patients, who often leave the ED confused and concerned. To address this training need, we developed the Uncertainty Communication Education Module (UCEM) to teach physicians how to discuss diagnostic uncertainty. The purpose of the study is to evaluate the effectiveness of the UCEM in improving physician communications.
METHODS
The trial is a multicenter, two-arm randomized controlled trial designed to teach communication skills using simulation-based mastery learning (SBML). Resident emergency physicians from two training programs will be randomly assigned to immediate or delayed receipt of the two-part UCEM intervention after completing a baseline standardized patient encounter. The two UCEM components are: 1) a web-based interactive module, and 2) a smart-phone-based game. Both formats teach and reinforce communication skills for patient cases involving diagnostic uncertainty. Following baseline testing, participants in the immediate intervention arm will complete a remote deliberate practice session via a video platform and subsequently return for a second study visit to assess if they have achieved mastery. Participants in the delayed intervention arm will receive access to UCEM and remote deliberate practice after the second study visit. The primary outcome of interest is the proportion of residents in the immediate intervention arm who achieve mastery at the second study visit.
DISCUSSION
Patients' understanding of the care they received has implications for care quality, safety, and patient satisfaction, especially when they are discharged without a definitive diagnosis. Developing a patient-centered diagnostic uncertainty communication strategy will improve safety of acute care discharges. Although use of SBML is a resource intensive educational approach, this trial has been deliberately designed to have a low-resource, scalable intervention that would allow for widespread dissemination and uptake.
TRIAL REGISTRATION
The trial was registered at clinicaltrials.gov (NCT04021771). Registration date: July 16, 2019.",2020,Resident emergency physicians from two training programs will be randomly assigned to immediate or delayed receipt of the two-part UCEM intervention after completing a baseline standardized patient encounter.,"['Resident emergency physicians from two training programs', 'patients in the emergency department']","['teach communication skills using simulation-based mastery learning (SBML', 'SBML', 'Simulation-based mastery learning compared to standard education', 'UCEM']",[],"[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.165051,Resident emergency physicians from two training programs will be randomly assigned to immediate or delayed receipt of the two-part UCEM intervention after completing a baseline standardized patient encounter.,"[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'McCarthy', 'Affiliation': 'Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, 211 East Ontario, Suite 200, Chicago, IL, 60611, USA. d-mccarthy2@northwestern.edu.'}, {'ForeName': 'Rhea E', 'Initials': 'RE', 'LastName': 'Powell', 'Affiliation': 'Division of General Internal Medicine and Geriatrics, Northwestern University, Philadelphia, PA, USA.'}, {'ForeName': 'Kenzie A', 'Initials': 'KA', 'LastName': 'Cameron', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Salzman', 'Affiliation': 'Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, 211 East Ontario, Suite 200, Chicago, IL, 60611, USA.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Papanagnou', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Amanda Mb', 'Initials': 'AM', 'LastName': 'Doty', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Benjamin E', 'Initials': 'BE', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Piserchia', 'Affiliation': 'Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, 211 East Ontario, Suite 200, Chicago, IL, 60611, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Klein', 'Affiliation': 'Department of Emergency Medicine, Northwestern University Feinberg School of Medicine, 211 East Ontario, Suite 200, Chicago, IL, 60611, USA.'}, {'ForeName': 'Xiao C', 'Initials': 'XC', 'LastName': 'Zhang', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'McGaghie', 'Affiliation': 'Department of Medical Education, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Thomas Jefferson University, Philadelphia, PA, USA.'}]",BMC medical education,['10.1186/s12909-020-1926-y']
3167,31525489,Peer mentorship to reduce suicide attempts among high-risk adults (PREVAIL): Rationale and design of a randomized controlled effectiveness-implementation trial.,"RATIONALE
Novel approaches to suicide prevention are needed to address increasing rates of suicide deaths. Research suggests that interventions led by certified Peer Specialists may improve suicide protective factors such as hope and connectedness; however, the effectiveness of a Peer Specialist intervention for reducing suicidal thoughts or behaviors has not previously been tested empirically.
DESIGN
We describe the methodology of a randomized controlled hybrid effectiveness-implementation trial of a peer specialist intervention known as PREVAIL (Peers for Valued Living). The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized. Secondary effectiveness outcomes include medically serious suicide attempts according to chart review and self-reported self-efficacy to avoid suicide. We also describe suicide risk management, supervision, and fidelity monitoring in the context of Peer Specialist providers and our methods for assessing implementation barriers and facilitators.
CONCLUSION
The PREVAIL trial will demonstrate novel methods for incorporating peer providers into a suicide prevention effectiveness trial with high-risk study participants. PREVAIL's hybrid effectiveness-implementation design aims to maximize the likelihood of rapid implementation in the community if shown to be effective.",2019,The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized.,"['adults at high risk for suicide who have been psychiatrically hospitalized', 'high-risk adults (PREVAIL', 'Peers for Valued Living']","['Peer mentorship', 'peer mentorship intervention', 'Peer Specialist intervention', 'minimally enhanced usual care condition']",['medically serious suicide attempts according to chart review and self-reported self-efficacy to avoid suicide'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C3152857', 'cui_str': 'Prevail'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]","[{'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.132837,The primary effectiveness aim is to determine whether the 3-month peer mentorship intervention compared to a minimally enhanced usual care condition reduces suicide attempts and suicidal ideation among adults at high risk for suicide who have been psychiatrically hospitalized.,"[{'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Lapidos', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States. Electronic address: alapidos@umich.edu.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Abraham', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States; University of Detroit Mercy, Department of Psychology, Detroit, MI, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jagusch', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Garlick', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Walters', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States; Consulting for Statistics, Computing & Analytics Research, University of Michigan, Ann Arbor, MI, United States.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Vega', 'Affiliation': 'Humannovations, Los Angeles, CA, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Damschroder', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Forman', 'Affiliation': 'VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Ahmedani', 'Affiliation': 'Henry Ford Health System, Detroit, MI, United States.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Pfeiffer', 'Affiliation': 'University of Michigan Medical School, Department of Psychiatry, Ann Arbor, MI, United States; VA Center for Clinical Management Research, Ann Arbor, MI, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105850']
3168,32088670,Effect of Nebulized Eucalyptus for Preventing Ventilator-associated Pneumonia in Patients Under Mechanical Ventilation: A Randomized Double Blind Clinical Trial.,"Background
Pneumonia caused by the ventilator is the most common acquired infection in the intensive care unit (ICU), which increases the morbidity and mortality of the patients. Eucalyptus plant has antiseptic properties that may mollify such morbidity and mortality.
Objective
To assess the effect of Eucalyptus incense on prevention of pneumonia in patients with endotracheal tube in the ICU.
Research Design
A randomized controlled clinical trial with parallel groups of 100 patients undergoing mechanical ventilation.
Setting
An ICU in a teaching hospital.
Interventions
Randomization to received Eucalyptus solution 5% (intervention group = 50) and received 10 cc distilled water as an inhaler 3 times/d (every 8 h/d for 20 min) (control group = 50).
Primary Outcome Measures
The incidence of early and delay pneumonia and pulmonary infections based on clinical pulmonary infection criteria were assessed.
Results
The incidence of late pneumonia was significantly lower in the intervention group compared with control groups (P < .01). The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P < .01).
Conclusion
The results present study showed that Eucalyptus inhalation is effective in reducing the incidence of pulmonary infection in patients under ventilation.",2020,"The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P < .01).
","['patients under ventilation', '100 patients undergoing mechanical ventilation', 'patients with endotracheal tube in the ICU.\nResearch Design', 'Patients Under Mechanical Ventilation']","['Eucalyptus solution', 'Eucalyptus incense', 'Nebulized Eucalyptus']","['incidence of late pneumonia', 'prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus', 'incidence of early and delay pneumonia and pulmonary infections', 'morbidity and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}]","[{'cui': 'C0015148', 'cui_str': 'Eucalyptus'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C0006836', 'cui_str': 'Monilia'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",100.0,0.172294,"The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P < .01).
","[{'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Ali Karimpour', 'Affiliation': ''}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Hematpour', 'Affiliation': ''}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Aminisaman', 'Affiliation': ''}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': ''}, {'ForeName': 'Seyed', 'Initials': 'S', 'LastName': 'Morteza Karimian', 'Affiliation': ''}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Mumtaz', 'Affiliation': ''}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Kaviannejad', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3169,32045493,"Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects.","AIMS
This investigation characterised tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 antibody TAK-079.
METHODS
A randomised, double-blind, placebo-controlled trial of a single intravenous (i.v.) infusion or subcutaneous (s.c.) injection of TAK-079 at escalating doses in healthy subjects (n = 74), who were followed for 92 days postexposure.
RESULTS
TAK-079 was well tolerated. All adverse events were mild or moderate. There were no withdrawals, infusion, or injection site reactions over the tested i.v. and s.c. doses up to 0.06 and 0.6 mg kg -1 , respectively. At higher doses, transient cytokine level increases, following i.v. administration, coincided with reduction in CD38-expressing cells; clinical symptoms included mild pyrexia, headache, and postural hypotension. Following an i.v. infusion of 0.06 mg kg -1 TAK-079, maximum observed serum concentration (C max ) was 100.4 (%CV: 52) ng mL -1 , time to C max was the end of infusion and natural killer (NK_ cells were reduced 93.8 (±8.5) % from baseline levels. Following a s.c. injection of 0.6 mg kg -1 TAK-079, C max was 23.0 (%CV: 67) ng mL -1 with time to C max of 24 (range 7.98-96.02) hours, and plasmablasts were subsequently reduced 93.4 (±8.8) % from predose levels. Serum immunoglobulin (Ig)M, IgA and IgG levels were reduced by 15-60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c. Reductions in NK cells at 0.6 mg kg -1 s.c. were approximately 2-3 times more durable than at 0.06 mg kg -1 i.v.
CONCLUSIONS
TAK-079 was well tolerated and s.c. administration elicited more durable reductions in plasmablasts and NK cells. This plasmacytolytic profile could be useful for treating disorders caused by plasma or NK cells, malignant counterparts, and/or pathogenic antibodies.",2020,"Serum IgM, IgA and IgG levels were reduced by 15% to 60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c.","['Healthy Subjects', 'healthy subjects (n=74']","['placebo', 'TAK-079', 'single intravenous (i.v.) infusion or subcutaneous (s.c']","['CD38-expressing cells; clinical symptoms included mild pyrexia, headache, and postural hypotension', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Anti-CD38 Cytolytic Antibody TAK-079', 'durable reductions in plasmablasts and NK cells', 'Serum IgM, IgA and IgG levels', 'tolerated', 'transient cytokine level', 'Reductions in NK cells']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0239574', 'cui_str': 'Low grade fever'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.468853,"Serum IgM, IgA and IgG levels were reduced by 15% to 60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c.","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Fedyk', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Annelize', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Parexel, Harrow, UK.'}, {'ForeName': 'Glennda', 'Initials': 'G', 'LastName': 'Smithson', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Estevam', 'Affiliation': 'Takeda Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Gezim', 'Initials': 'G', 'LastName': 'Lahu', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepcke', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Jianchang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Takeda Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Lachy', 'Initials': 'L', 'LastName': 'Mclean', 'Affiliation': 'Takeda California, San Diego, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14241']
3170,32234610,"Examining the associations between alcohol-related parental communication, alcohol use, and protective behavioral strategy use among young adults.","Underage alcohol use is a public health concern as it remains prevalent and problematic. Protective behavioral strategies (PBS) may prevent or reduce alcohol-related consequences, yet daily-level findings show they instead might be associated with increased drinking and consequences. While parents are a possible source of influence to their child's decision making, it is unclear whether parental communication about alcohol affects drinking outcomes, with mixed findings noted in the literature. Furthermore, little research focuses on understanding how parental communication may impact the use of PBS. This study assessed whether alcohol specific parental communication would be associated with reduced drinking and increased use of PBS. Data from baseline and 3-month follow up were evaluated from a control group of a larger randomized controlled trial on 18- to 20-year-olds in the U.S. (N = 269). Outcomes included drinks per week, peak drinks per occasion, negative consequences and use of PBS. Using negative binomial regression modeling, controlling for age, sex, and whether participants lived with parents, findings revealed that parental communication was not associated with drinks per week, peak drinks per occasion, or negative consequences reported 3 months later. However, it was positively associated with limiting/stopping drinking PBS, manner of drinking PBS, and serious harm reduction PBS reported 3 months later. Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking. Research is needed to determine why parental communication may influence the use of PBS and how we can strengthen the quality or focus of communication to ultimately increase the impact on risk behaviors.",2020,Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking.,"['18- to 20-year-olds in the U.S', 'young adults']",['Protective behavioral strategies (PBS'],"['drinks per week, peak drinks per occasion, negative consequences and use of PBS']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0033770', 'cui_str': 'Prune belly syndrome'}]",,0.0247036,Results suggest that parental communication about alcohol may be more effective in increasing the use of protective behavioral strategies rather than reduction of drinking.,"[{'ForeName': 'Dana M', 'Initials': 'DM', 'LastName': 'Litt', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States. Electronic address: Dana.Litt@unthsc.edu.'}, {'ForeName': 'Tracey A', 'Initials': 'TA', 'LastName': 'Garcia', 'Affiliation': 'Department of Psychology, Murray State University, Murray, KY, United States.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Lowery', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Cassidy', 'Initials': 'C', 'LastName': 'LoParco', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Annalynn M', 'Initials': 'AM', 'LastName': 'Galvin', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Box 354944, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Department of Health Behavior and Health Systems, School of Public Health, University of North Texas Health Science Center, Fort Worth, TX, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106398']
3171,32126750,Continuous infusion versus intermittent bolus injection of propofol during endoscopic retrograde cholangiopancreatography.,"BACKGROUND/AIMS
It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation in endoscopic retrograde cholangiopancreatography (ERCP). We aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of propofol during therapeutic ERCP.
METHODS
In this prospective study, we randomly assigned 232 patients undergoing therapeutic ERCP to either continuous infusion (CI group, n = 113) or intermittent bolus injection (BI group, n = 119) of propofol. The primary outcome was the quality of sedation as assessed by the endoscopist. Other sedation-related parameters included sedation induction time, total dose of propofol, recovery time, involuntary patient movement, and adverse events.
RESULTS
Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both). However, patients in the CI group had a significantly longer sedation induction time (5.28 minutes vs. 4.34 minutes, p < 0.01) and received a higher dose of propofol than patients in the BI group (4.22 mg/kg vs. 2.08 mg/kg, p < 0.01). There was no significant difference in adverse events between the two groups.
CONCLUSION
Continuous infusion of propofol during therapeutic ERCP had the advantage over intermittent bolus injection of maintaining a constant level of sedation without increasing adverse events. However, it was associated with an increased total dose of propofol and prolonged sedation induction time.",2020,"Results
Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both).",['232 patients undergoing'],"['therapeutic ERCP to either continuous infusion (CI group, n = 113) or intermittent bolus injection (BI group, n = 119) of propofol', 'propofol']","['efficacy and safety', 'sedation induction time', 'quality of sedation', 'sedation induction time, total dose of propofol, recovery time, involuntary patient movement, and adverse events', 'adverse events', 'Overall satisfaction with sedation by the endoscopist and monitoring nurse', 'total dose of propofol and prolonged sedation induction time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0444889', 'cui_str': 'Continuous infusion (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",232.0,0.0230448,"Results
Overall satisfaction with sedation by the endoscopist and monitoring nurse were significantly higher in the CI group than the BI group (mean satisfaction score, 9.66 vs. 8.0 and 9.47 vs. 7.96, respectively, p < 0.01 for both).","[{'ForeName': 'Jae Gon', 'Initials': 'JG', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Kyo-Sang', 'Initials': 'KS', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}, {'ForeName': 'Young Jae', 'Initials': 'YJ', 'LastName': 'Byun', 'Affiliation': 'Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea.'}]",The Korean journal of internal medicine,['10.3904/kjim.2018.233']
3172,32067249,"Pharmacokinetics, pharmacodynamics and safety of the inverse retinoic acid-related orphan receptor γ agonist AZD0284.","AIMS
Retinoic acid-related orphan receptor γ (RORγ), a master regulator of T-helper 17 (Th17) cell function and differentiation, is an attractive target for treatment of Th17-driven diseases. This first-in-human study aimed to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of the inverse RORγ agonist AZD0284.
METHODS
We conducted a phase I, randomized, single-blind, placebo-controlled, two-part, first-in-human study with healthy subjects receiving single (4-238 mg) or multiple (12-100 mg) oral doses of AZD0284 or placebo after overnight fasting. Subjects in the one single dose cohort additionally received a single dose of AZD0284 after a high-calorie meal. AZD0284 plasma concentrations, as well as inhibition of ex vivo-stimulated interleukin (IL)-17A release in whole blood, were frequently measured after both single and multiple dosing.
RESULTS
Eighty-three men participated in the study. AZD0284 was absorbed rapidly into plasma after oral dosing and exhibited a terminal half-life of 13-16 hours. Both the area under the concentration-time curve (AUC) and maximum concentration (C max ) increased subproportionally with increasing dose (95% confidence intervals of slope parameter were 0.71-0.84 and 0.72-0.88 for AUC and C max , respectively). Food intake delayed the absorption of AZD0284 but did not affect the overall exposure or half-life. AZD0284 showed dose-dependent reduction of ex vivo-stimulated IL-17A release after both single and multiple doses. No significant safety concerns were identified in the study.
CONCLUSIONS
AZD0284 was well tolerated, rapidly and dose-dependently absorbed, and reduced stimulated IL-17A release after single and multiple dosing. The results of this study support further clinical development of AZD0284.",2020,AZD0284 showed dose-dependent reduction of ex vivo stimulated IL-17A release after both single and multiple doses.,"['healthy subjects receiving single (4 mg to 238 mg) or multiple (12 to 100 mg', 'Eighty-three men participated in the study']","['Retinoic Acid-Related Orphan Receptor γ (RORγ', 'placebo', 'oral doses of AZD0284 or placebo']","['pharmacokinetics, pharmacodynamics, safety, and tolerability', 'stimulated IL-17A release', 'reduction of ex vivo stimulated IL-17A release', 'AZD0284 plasma concentrations', 'concentration-time curve (AUC) and maximum concentration (C max ', 'Pharmacokinetics, Pharmacodynamics, and Safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",83.0,0.0857159,AZD0284 showed dose-dependent reduction of ex vivo stimulated IL-17A release after both single and multiple doses.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Asimus', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca Gaithersburg, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Palmér', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca Gothenburg, Sweden.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Early Phase Clinical Unit, Parexel, London, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Forsman', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lundin', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Olsson', 'Affiliation': 'Early Biostats and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Pehrson', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Patient Safety, Respiratory, Inflammation and Autoimmunity, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Muir', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'Study Delivery, Early Oncology Clinical, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Carlert', 'Affiliation': 'Early Product Development, Pharmaceutical Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Close', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Keeling', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",British journal of clinical pharmacology,['10.1111/bcp.14253']
3173,32103635,"Effect of a mindfulness programme for long-term care residents with type 2 diabetes: A cluster randomised controlled trial measuring outcomes of glycaemic control, relocation stress and depression.","AIMS
The aim of this study was to determine physical, behavioural and psychosocial effects of a newly developed mindfulness programme for older adults with type 2 diabetes relocating to long-term care facility.
BACKGROUND
Taiwan is viewed as an ""aged society"" with significant proportion of the population living in a long-term care facility. Approximately one third of residents living in long-term care facilities have been diagnosed with type 2 diabetes, and disruption to management of their glycaemic levels is at risk for up to one year after relocating to a long-term care facility.
DESIGN
A cluster randomised controlled trial was used to examine the effects of a newly developed mindfulness programme on outcomes of glycaemic levels, relocation stress and depression.
METHODS
A total of 140 participants were recruited from six long-term care facilities in Southern Taiwan. A mindfulness programme was delivered over 9 weeks and consisted of meditations, education and exercise techniques that were delivered by a Registered Nurse trained in mindfulness strategies. Participants in the control group received routine care as provided in the facilities, including routine check-ups at diabetes clinics as necessary. Data were analysed by Johnson-Neyman technique and generalised estimating equations.
RESULTS
In total, 120 residents completed the study. The majority of patients were female (64.8%), and 83.5% of the sample were financially supported by their children. The results showed significant improvements in glycated haemoglobin (HbA1c), relocation stress (Wald χ 2 = 78.91) and depression (Wald χ 2 = 45.70) between groups. In the intervention group, the mean of HbA1c levels showed 16.4% reduction (Mean differences = 1.3; SD = 0.3). However, there were no significant differences in relocation stress and depression within groups.
CONCLUSION
The results provided positive effects of the mindfulness programme for older people with diabetes moving into long-term care facilities. The programme will assist in future planning for diabetes care in long-term care facilities.
IMPLICATIONS FOR PRACTICE
To incorporate the mindfulness program into existing diabetes education programs for older people living in LTCFs. Further investigation on the sustainability of the mindfulness program is warranted.",2020,"In the intervention group, the mean of HbA1c levels showed 16.4% reduction (Mean differences = 1.3; SD = 0.3).","['120 residents completed the study', 'older adults with type 2 diabetes relocating to long-term care facility', '140 participants were recruited from six long-term care facilities in Southern Taiwan', 'older people living in LTCFs', 'long-term care residents with type 2 diabetes', 'older people with diabetes moving into long-term care facilities']","['routine care', 'mindfulness program into existing diabetes education programs', 'mindfulness programme']","['glycated haemoglobin (HbA1c), relocation stress (Wald χ 2 \xa0=\xa078.91) and depression', 'mean of HbA1c levels', 'relocation stress and depression', 'physical, behavioural and psychosocial effects', 'glycaemic levels, relocation stress and depression']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0023977'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0578671', 'cui_str': 'Does move (finding)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",140.0,0.0314963,"In the intervention group, the mean of HbA1c levels showed 16.4% reduction (Mean differences = 1.3; SD = 0.3).","[{'ForeName': 'Shu-Ming', 'Initials': 'SM', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, School of Nursing, Fooyin University, Kaohsiung, Taiwan.'}, {'ForeName': 'Huey-Shyan', 'Initials': 'HS', 'LastName': 'Lin', 'Affiliation': 'Department of Health-Business Administration, Fooyin University, Kaohsiung, Taiwan.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Atherton', 'Affiliation': ""Department of Cardiology, Royal Brisbane and Women's Hospital (RBWH), Herston, Qld, Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': ""Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne & University of Melbourne, Fitzroy, Vic, Australia.""}, {'ForeName': 'Chiung-Jung Jo', 'Initials': 'CJ', 'LastName': 'Wu', 'Affiliation': 'School of Nursing, Midwifery and Paramedicine, University of the Sunshine Coast (USC), Sippy Downs, Qld, Australia.'}]",International journal of older people nursing,['10.1111/opn.12312']
3174,32103640,Effect of an end-of-life gerontological nursing education programme on the attitudes and knowledge of clinical nurses: A non-randomised controlled trial.,"AIMS
To evaluate how a structured interactive two-day education programme for clinical nurses on end-of-life (EOL) care for older people affects nurses' attitudes and knowledge.
DESIGN
Non-randomised controlled trial.
METHODS
Nurses were recruited separately for intervention and control groups. The intervention group assisted older patients with EOL care and recruited patients for the programme. To prevent sampling bias, control group nurses were recruited from a facility with numerous EOL care opportunities. The intervention was a two-day educational programme. Using valid and reliable scales, we evaluated the attitudes (total score range: 26-130) and knowledge (total score range: 0-51) of the intervention group four times (pretraining, post-training, 3 months, 6 months) and the control group three times (baseline, 3 months, 6 months) between January 2016 and April 2017. Analysis of covariance examined both groups' score changes at 3 and 6 months while adjusting for confounding factors.
RESULTS
Participants were 338 nurses caring primarily for older people (intervention group: 164; control group: 174); 142 responded at all measurement points. The change in mean value of the attitude scale from baseline to 3 months (differences in the groups' attitude scores = 7.33; 95% CI = 2.43-12.24; p = .004) and 6 months (differences in groups' attitude scores = 5.77; 95% CI = 0.17-11.37; p = .044) was greater in the intervention group. Moreover, the mean knowledge scale score change from baseline to 3 months was greater in the intervention group (differences in groups' knowledge scores = 5.74; 95% CI = 4.07 to 7.39; p < .001). There was no evidence of a change in this score between baseline and 6 months.
CONCLUSION
The programme improved nurses' medium- to long-term attitudes and knowledge. Thus, it may help nurses enhance the quality of care they provide.
IMPLICATIONS FOR PRACTICE
A two-day educational program improves nurses' medium- to long-term attitudes and knowledge on end-oflife care. For quality end-of-life care for older people, a structured and evidence-based educational program should be provided to nursing staff.",2020,A two-day educational program improves nurses' medium- to long-term attitudes and knowledge on end-oflife care.,"['older people', ""older people affects nurses' attitudes and knowledge"", 'Nurses', 'older patients with EOL care and recruited patients for the programme', 'Participants were 338 nurses caring primarily for older people (intervention group: 164; control group: 174); 142 responded at all measurement points']","['end-of-life gerontological nursing education programme', 'structured interactive two-day education programme']","['attitudes and knowledge of clinical nurses', 'mean knowledge scale score change', 'mean value of the attitude scale']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013636', 'cui_str': 'Education, Nursing'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",338.0,0.0586994,A two-day educational program improves nurses' medium- to long-term attitudes and knowledge on end-oflife care.,"[{'ForeName': 'Akemi', 'Initials': 'A', 'LastName': 'Okumura-Hiroshige', 'Affiliation': 'Department of System Management in Nursing, Graduate School of Health Care Sciences, Tokyo Medical and Dental University, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Fukahori', 'Affiliation': 'Division of Gerontological Nursing, Faculty of Nursing and Medical Care, KEIO University, Kanagawa, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Yoshioka', 'Affiliation': 'Matsue City Hospital, Matsue, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Nishiyama', 'Affiliation': 'Arima Onsen Hospital, Kobe, Japan.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Takamichi', 'Affiliation': 'National Hospital Organization Iou Hospital, Kanazawa, Japan.'}, {'ForeName': 'Miyoko', 'Initials': 'M', 'LastName': 'Kuwata', 'Affiliation': 'Oume Keiyu Hospital, Ome, Japan.'}]",International journal of older people nursing,['10.1111/opn.12309']
3175,32108326,Three-field versus two-field lymphadenectomy in transthoracic oesophagectomy for oesophageal squamous cell carcinoma: short-term outcomes of a randomized clinical trial.,"BACKGROUND
The benefit and harm of three-field lymphadenectomy for oesophageal cancer are still unknown. The aim of this study was to compare overall survival and morbidity and mortality between three- and two-field lymphadenectomy in patients with oesophageal squamous cell carcinoma.
METHODS
Between March 2013 and November 2016, patients with squamous cell carcinoma of the middle or distal oesophagus were assigned randomly to open oesophagectomy with three-field (cervical-thoracic-abdominal) or two-field (thoracic-abdominal) lymphadenectomy. No chemo(radio) therapy was given before surgery. This paper reports on the secondary outcomes of the study: pathology and surgical complications.
RESULTS
Some 400 patients were randomized, 200 in each group. A median of 37 (i.q.r. 30-49) lymph nodes were dissected in the three-field group, compared with 24 (18-30) in the two-field group (P < 0·001). Some 43 of 200 patients (21·5 per cent) in the three-field group had cervical lymph node metastasis. More patients in the three-field group had pN3 disease: 21 of 200 (10·5 per cent) versus 10 of 200 (5·0 per cent) (P = 0·040). The rate and severity of postoperative complications were comparable between the two groups, except that six patients in the three-field arm needed reintubation compared with none in the two-field group (3·0 versus 0 per cent; P = 0·030). The 90-day mortality rate was 0 per cent in the three-field group and 0·5 per cent (1 patient) in the two-field group (P = 1·000).
CONCLUSION
Oesophagectomy with three-field lymphadenectomy increased the number of lymph nodes dissected and led to stage migration owing to a 21·5 per cent rate of cervical lymph node metastasis. Postoperative complications were largely comparable between two- and three-field lymphadenectomy. Registration number: NCT01807936 ( https://www.clinicaltrials.gov).",2020,Some 43 of 200 patients (21·5 per cent) in the three-field group had cervical lymph node metastasis.,"['Between March 2013 and November 2016', 'oesophageal squamous cell carcinoma', 'patients with squamous cell carcinoma of the middle or distal oesophagus', 'patients with oesophageal squamous cell carcinoma', '400 patients were randomized, 200 in each group']","['transthoracic oesophagectomy', 'three- and two-field lymphadenectomy', 'open oesophagectomy with three-field (cervical-thoracic-abdominal) or two-field (thoracic-abdominal) lymphadenectomy', 'field lymphadenectomy']","['rate and severity of postoperative complications', '90-day mortality rate', 'cervical lymph node metastasis', 'overall survival and morbidity and mortality', 'pN3 disease', 'Postoperative complications']","[{'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0014876', 'cui_str': 'Esophagus'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach (qualifier value)'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node structure (body structure)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",400.0,0.175214,Some 43 of 200 patients (21·5 per cent) in the three-field group had cervical lymph node metastasis.,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Miao', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ye', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Pathology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fan', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Radiation Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shao', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Fudan University Shanghai Cancer Centre, Shanghai, China.'}]",The British journal of surgery,['10.1002/bjs.11497']
3176,32091670,Musculoskeletal adaptations to strength training in frail elderly: a matter of quantity or quality?,"BACKGROUND
The improvement in muscle strength generally exceeds the increase in muscle size following strength training in frail elderly, highlighting the complex aetiology of strength deficit in aging. The aim of this study was to investigate the effect of heavy-load strength training on a broad number of factors related to specific strength in frail elderly.
METHODS
Thirty-four frail elderly men (n = 18) and women (n = 16) aged 67 to 98 (86 ± 7 years) were randomized to either a group performing strength training twice a week for 10 weeks (ST) or a non-exercising control group (CON). Knee extensor muscle strength was tested as one-repetition maximum (1RM) and isometric maximal voluntary contraction (MVC) torque. Muscle activation was assessed by the interpolated twitch technique, and muscle density [mean Hounsfield units (HU)] and intermuscular adipose tissue (IMAT) by computed tomography scans of the quadriceps femoris. Muscle biopsies from the vastus lateralis were obtained to investigate changes in intramyocellular lipids and single-fibre specific tension.
RESULTS
In ST, knee extension 1RM and MVC improved by 17 and 7%, respectively. Muscle cross-sectional area of the quadriceps femoris increased by 7%, accompanied by a 4% increase of muscle density. No changes in IMAT, voluntary activation level, single-fibre specific tension, or lipid content were observed.
CONCLUSIONS
In contrast to several previous reports, the improvements in isometric muscle strength and muscle area were in good agreement in the present study. The training-induced increase in muscle density was not due to changes in skeletal muscle lipid content. Instead, the increase in muscle density may reflect increased packing of contractile material or simply an increased ratio of muscle tissue relative to IMAT.",2020,"Muscle cross-sectional area of the quadriceps femoris increased by 7%, accompanied by a 4% increase of muscle density.","['frail elderly', 'Thirty-four frail elderly men (n = 18) and women (n = 16) aged 67 to 98 (86 ± 7 years']","['strength training twice a week for 10 weeks (ST) or a non-exercising control group (CON', 'heavy-load strength training', 'strength training']","['repetition maximum (1RM) and isometric maximal voluntary contraction (MVC) torque', 'Muscle activation', 'muscle density', 'interpolated twitch technique, and muscle density [mean Hounsfield units (HU)] and intermuscular adipose tissue (IMAT', 'Knee extensor muscle strength', 'skeletal muscle lipid content', 'IMAT, voluntary activation level, single-fibre specific tension, or lipid content', 'knee extension 1RM and MVC', 'isometric muscle strength and muscle area', 'Muscle cross-sectional area of the quadriceps femoris']","[{'cui': 'C0079377', 'cui_str': 'Frail Elders'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch (finding)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}]",34.0,0.011672,"Muscle cross-sectional area of the quadriceps femoris increased by 7%, accompanied by a 4% increase of muscle density.","[{'ForeName': 'Sigve N', 'Initials': 'SN', 'LastName': 'Aas', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Breit', 'Affiliation': 'Department of Sport and Exercise Physiology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Karsrud', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Ole J', 'Initials': 'OJ', 'LastName': 'Aase', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Simen H', 'Initials': 'SH', 'LastName': 'Rognlien', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Kristoffer T', 'Initials': 'KT', 'LastName': 'Cumming', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Reggiani', 'Affiliation': 'Department of Biomedical Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Seynnes', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}, {'ForeName': 'Andrea P', 'Initials': 'AP', 'LastName': 'Rossi', 'Affiliation': 'Section of Geriatrics, Department of Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Toniolo', 'Affiliation': 'Department of Biomedical Sciences, University of Padua, Padua, Italy.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Sognsveien, Oslo, Norway.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12543']
3177,32088746,Prospective evaluation of fexapotide triflutate injection treatment of Grade Group 1 prostate cancer: 4-year results.,"PURPOSE
This study was undertaken to determine the safety and efficacy of fexapotide triflutate (FT) 2.5 mg and 15 mg for the treatment of Grade Group 1 prostate cancer.
METHODS
Prospective randomized transrectal intraprostatic single injection FT 2.5 mg (n = 49), FT 15 mg (n = 48) and control active surveillance (AS) (n = 49) groups were compared in 146 patients at 28 U.S. sites, with elective AS crossover (n = 18) to FT after first follow-up biopsy at 45 days. Patients were followed for 5 years including biopsies (baseline, 45 days, and 18, 36, and 54 months thereafter), and urological evaluations with PSA every 6 months. Patients with Gleason grade increase or who elected surgical or radiotherapeutic intervention exited the study and were cumulatively included in the data analysis. Percentage of normal biopsies in baseline focus quadrant, tumor grades, and volumes; and outcomes including Gleason grade in entire prostate as well as treated prostate lobe, interventions associated with Gleason grade increase and total incidence of interventions were assessed.
RESULTS
Significantly improved long-term clinical outcomes were found after 4-year follow-up, with percentages of patients progressing to interventions with and without Gleason grade increase significantly reduced by FT single treatment. Results in the FT 15-mg group were superior to the FT 2.5-mg dose group. There were no drug-related serious adverse events (SAEs).
CONCLUSIONS
FT showed statistically significant long-term efficacy in the treatment of Grade Group 1 patients regarding clinical and pathological progression. FT 15 mg showed superior results to FT 2.5 mg. There were no drug-related SAEs; FT injection was well tolerated.",2020,"RESULTS
Significantly improved long-term clinical outcomes were found after 4-year follow-up, with percentages of patients progressing to interventions with and without Gleason grade increase significantly reduced by FT single treatment.","['Patients with Gleason grade increase or who elected surgical or radiotherapeutic intervention exited the study and were cumulatively included in the data analysis', 'Grade Group 1 prostate cancer']","['transrectal intraprostatic single injection FT 2.5\xa0mg (n\u2009=\u200949), FT 15\xa0mg (n\u2009=\u200948) and control active surveillance (AS', 'fexapotide triflutate (FT', 'fexapotide triflutate injection']","['long-term clinical outcomes', 'tolerated', 'Gleason grade increase and total incidence of interventions', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0205518', 'cui_str': 'Transrectal approach (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",146.0,0.0170791,"RESULTS
Significantly improved long-term clinical outcomes were found after 4-year follow-up, with percentages of patients progressing to interventions with and without Gleason grade increase significantly reduced by FT single treatment.","[{'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Shore', 'Affiliation': 'Carolina Urologic Research Center, Myrtle Beach, SC, USA. NShore@gsuro.com.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kaplan', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Tutrone', 'Affiliation': 'Chesapeake Urology Research Associates, Baltimore, MD, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Levin', 'Affiliation': 'Chesapeake Urology Research Associates, Towson, MD, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Bailen', 'Affiliation': 'First Urology, Louisville, KY, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hay', 'Affiliation': 'Willamette Urology, Salem, OR, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kalota', 'Affiliation': 'Urological Associates of Southern Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bidair', 'Affiliation': 'San Diego Clinical Trials, San Diego, CA, USA.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Freedman', 'Affiliation': 'Freedman Urology, Las Vegas, NV, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Goldberg', 'Affiliation': 'UT Southwestern Department of Urology, Lewisville, TX, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Snoy', 'Affiliation': 'Urology Group of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Jonathan I', 'Initials': 'JI', 'LastName': 'Epstein', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}]",World journal of urology,['10.1007/s00345-020-03127-w']
3178,31957686,A brief motivational intervention for enhancing medication adherence for adolescents with bipolar disorder: A pilot randomized trial.,"BACKGROUND
Youth with bipolar disorder (BP) exhibit poor medication adherence, contributing to affective recurrence. Brief Motivational Interventions (BMIs) improve adherence among adolescents with chronic conditions.
METHODS
In an open pilot series, we developed a 3-session BMI for BP adolescents targeting medication adherence and conducted a pilot randomized trial comparing Standard Care (SC) versus SC+BMI. Participants include 43 adolescents with BP prescribed psychotropic medications. We assessed medication adherence objectively via bluetooth-enabled electronic pillbox (MedTracker). A blinded evaluator assessed mood symptoms at intake, 3- and 6-months.
RESULTS
The BMI was well-received. Average objective medication adherence increased with time in SC+BMI, but decreased in SC-Alone (p < 0.0001). Adolescents' baseline self-rated expectation of improvement with treatment moderated the effect of treatment on improvement in adherence over time (p = 0.003). Across groups, poor adherence predicted increased likelihood of depression and hypo/mania symptoms in the subsequent two weeks; medication adherence mediated the effect of the BMI on the likelihood of depressive symptoms (p = 0.007).
LIMITATIONS
Electronic pillbox use (across groups) may enhance adherence, resulting in overestimates compared with naturalistic conditions. This pilot randomized trial may have been underpowered to detect some group differences.
CONCLUSIONS
A BMI offers promise as a disseminable adjunctive intervention for improving medication adherence for adolescents with BP. Future studies with larger samples can establish efficacy. NCT03203720.",2020,"Average objective medication adherence increased with time in SC+BMI, but decreased in SC-Alone","['Participants include 43 adolescents with BP prescribed psychotropic medications', 'adolescents with bipolar disorder', 'adolescents with chronic conditions', 'Youth with bipolar disorder (BP', 'adolescents with BP']","['bluetooth-enabled electronic pillbox (MedTracker', 'Standard Care (SC) versus SC+BMI', 'SC-Alone', '3-session BMI', 'motivational intervention', 'Brief Motivational Interventions (BMIs']","['likelihood of depression and hypo/mania symptoms', 'Average objective medication adherence', 'likelihood of depressive symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",43.0,0.122982,"Average objective medication adherence increased with time in SC+BMI, but decreased in SC-Alone","[{'ForeName': 'Tina R', 'Initials': 'TR', 'LastName': 'Goldstein', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States. Electronic address: goldsteintr@upmc.edu.""}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Krantz', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Rachael K', 'Initials': 'RK', 'LastName': 'Fersch-Podrat', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Nina J', 'Initials': 'NJ', 'LastName': 'Hotkowski', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Merranko', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Sobel', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Axelson', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University, Columbus, OH, United States.""}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Douaihy', 'Affiliation': ""Western Psychiatric Hospital, University of Pittsburgh Medical Center, 3811 O'Hara St, BFT#531, Pittsburgh 15213, PA, United States.""}]",Journal of affective disorders,['10.1016/j.jad.2020.01.015']
3179,31720933,Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin.,"BACKGROUND
This study evaluated health-related quality of life (HRQOL) using patient-reported outcomes in subjects with mucinous appendiceal neoplasms who underwent cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) as part of a randomized trial comparing mitomycin with oxaliplatin.
METHODS
In this prospective multicenter study, 121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS, were randomized to receive mitomycin (divided 40 mg) or oxaliplatin (200 mg/m 2 ) for HIPEC. The Functional Assessment of Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire was utilized to assess HRQOL. The Trial Outcome Index (TOI) is a summary index responsive to changes in physical/functional outcomes. Repeated measures mixed models with an unstructured variance matrix were applied to assess changes in HRQOL longitudinally.
RESULTS
Baseline questionnaire compliance was 95.9%. Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017). The TOI was significantly lower in the mitomycin group compared with the oxaliplatin arm at 12 weeks (p = 0.044; score difference 6.35) and 24 weeks after surgery (p = 0.049; score difference 5.61). At 12 weeks after surgery, declines from baseline were significant in the TOI (p = 0.004; score decline 8.99), PWB (p < 0.001; score decline 2.83), and FWB (p < 0.001; score decline 3.42) in the mitomycin group but not the oxaliplatin group.
CONCLUSIONS
Compared with mitomycin, HIPEC perfusion with oxaliplatin results in significantly better physical and functional outcomes. With similar survival outcomes and complication rates, oxaliplatin should be considered as the chemoperfusion agent of choice in mucinous appendiceal cancer patients undergoing CRS/HIPEC.",2020,"Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017).","['mucinous appendiceal cancer patients undergoing CRS/HIPEC', 'Mucinous Appendiceal Cancer', '121 mucinous appendiceal cancer patients, with evidence of peritoneal dissemination who underwent CRS', 'subjects with mucinous appendiceal neoplasms who underwent']","['mitomycin, HIPEC perfusion with oxaliplatin', 'mitomycin with oxaliplatin', 'Oxaliplatin and Mitomycin', 'cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC', 'mitomycin', 'Cytoreductive Surgery/HIPEC', 'HIPEC', 'Cancer Therapy Neurotoxicity (FACT-G/NTX) questionnaire', 'oxaliplatin']","['FWB', 'Baseline physical well-being (PWB', 'PWB', 'overall survival', 'physical and functional outcomes', 'TOI', 'Health-Related Quality of Life']","[{'cui': 'C0496779', 'cui_str': 'Appendiceal Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C4087504', 'cui_str': 'Peritoneal dissemination'}, {'cui': 'C0003614', 'cui_str': 'Appendiceal Neoplasms'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1868801', 'cui_str': 'Hyperthermic Intraperitoneal Chemotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.159859,"Baseline physical well-being (PWB) was independently associated with overall survival (hazard ratio 0.79, 95% confidence interval 0.66-0.96; p = 0.017).","[{'ForeName': 'Omeed', 'Initials': 'O', 'LastName': 'Moaven', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Konstantinos I', 'Initials': 'KI', 'LastName': 'Votanopoulos', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mansfield', 'Affiliation': 'Department of Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bartlett', 'Affiliation': 'Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Russell', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McQuellon', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Stewart', 'Affiliation': 'Department of Surgery, University of Illinois, Chicago, IL, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Levine', 'Affiliation': 'Department of Surgery, Wake Forest University, Winston Salem, NC, USA. elevine@wakehealth.edu.'}]",Annals of surgical oncology,['10.1245/s10434-019-08064-6']
3180,31841363,Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non-Small-Cell Lung Cancer.,"PURPOSE
RTOG 0617 compared standard-dose (SD; 60 Gy) versus high-dose (HD; 74 Gy) radiation with concurrent chemotherapy and determined the efficacy of cetuximab for stage III non-small-cell lung cancer (NSCLC).
METHODS
The study used a 2 × 2 factorial design with radiation dose as 1 factor and cetuximab as the other, with a primary end point of overall survival (OS).
RESULTS
Median follow-up was 5.1 years. There were 3 grade 5 adverse events (AEs) in the SD arm and 9 in the HD arm. Treatment-related grade ≥3 dysphagia and esophagitis occurred in 3.2% and 5.0% of patients in the SD arm v 12.1% and 17.4% in the HD arm, respectively ( P = .0005 and < .0001). There was no difference in pulmonary toxicity, with grade ≥3 AEs in 20.6% and 19.3%. Median OS was 28.7 v 20.3 months ( P = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P = .055), respectively. Factors associated with improved OS on multivariable analysis were standard radiation dose, tumor location, institution accrual volume, esophagitis/dysphagia, planning target volume and heart V5. The use of cetuximab conferred no survival benefit at the expense of increased toxicity. The prior signal of benefit in patients with higher H scores was no longer apparent. The progression rate within 1 month of treatment completion in the SD arm was 4.6%. For comparison purposes, the resultant 2-year OS and PFS rates allowing for that dropout rate were 59.6% and 30.7%, respectively, in the SD arms.
CONCLUSION
A 60-Gy radiation dose with concurrent chemotherapy should remain the standard of care, with the OS rate being among the highest reported in the literature for stage III NSCLC. Cetuximab had no effect on OS. The 2-year OS rates in the control arm are similar to the PACIFIC trial.",2020,"Median OS was 28.7 v 20.3 months ( P = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P = .055), respectively.",['0617'],"['Cetuximab', 'High-Dose Chemoradiotherapy With or Without Cetuximab', 'Standard', 'NRG Oncology RTOG', 'cetuximab']","['toxicity', 'grade ≥3 dysphagia and esophagitis', 'OS', 'pulmonary toxicity', '2-year OS and PFS rates', '5-year OS and progression-free survival (PFS) rates', '2-year OS rates', 'survival benefit', 'overall survival (OS', 'tumor location, institution accrual volume, esophagitis/dysphagia, planning target volume and heart V5', 'Median OS', 'progression rate']",[],"[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0919924', 'cui_str': 'Pulmonary toxicity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.0980759,"Median OS was 28.7 v 20.3 months ( P = .0072) in the SD and HD arms, respectively, 5-year OS and progression-free survival (PFS) rates were 32.1% and 23% and 18.3% and 13% ( P = .055), respectively.","[{'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Pittsburgh, PA.'}, {'ForeName': 'Ritsuko R', 'Initials': 'RR', 'LastName': 'Komaki', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Masters', 'Affiliation': 'Medical Oncology Hematology Consultants, PA, Newark, DE.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Schild', 'Affiliation': 'Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bogart', 'Affiliation': 'State University of New York, Syracuse, NY.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Forster', 'Affiliation': 'Geisinger Medical Center, Danville, PA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Magliocco', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Vivek S', 'Initials': 'VS', 'LastName': 'Kavadi', 'Affiliation': 'Texas Oncology-Sugar Land, Sugar Land, TX.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Narayan', 'Affiliation': 'Saint Joseph Mercy Hospital, Ann Arbor, MI.'}, {'ForeName': 'Puneeth', 'Initials': 'P', 'LastName': 'Iyengar', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Clifford G', 'Initials': 'CG', 'LastName': 'Robinson', 'Affiliation': 'Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Raymond B', 'Initials': 'RB', 'LastName': 'Wynn', 'Affiliation': 'UPMC Shadyside Hospital, Pittsburgh, PA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Koprowski', 'Affiliation': 'Christiana Care Health Community Clinical Oncology Program, Newark, DE.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Olson', 'Affiliation': 'Baptist MD Anderson Cancer Center, Jacksonville, FL.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Meng', 'Affiliation': 'Ottawa Hospital and Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Pittsburgh, PA.'}, {'ForeName': 'Walter J', 'Initials': 'WJ', 'LastName': 'Curran', 'Affiliation': 'Emory University, Atlanta, GA.'}, {'ForeName': 'Hak', 'Initials': 'H', 'LastName': 'Choy', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01162']
3181,32075474,Influence of butyphthalide combined with urinary kallikrein in ACI treatment on neuro-cytokines and vascular endothelial function and its clinical effect.,"Objective: To study the influence of butyphthalide combined with urinary kallikrein in acute cerebral infarction (ACI) treatment on neuro-cytokines and indicators of vascular endothelial function, observe the curative effect and adverse effects, and discuss its safety and feasibility. Method: 110 ACI patients were chosen as the objects, and classified into observation group (55 cases) and control group (55 cases) according to the method of random number table. Butyphthalide injection combined with urinary kallikrein was adopted for the observation group based on conventional treatment, while cinepazide maleate injection combined with alprostadil injection was applied for the control group based on conventional treatment. The following indicators of both groups were compared before and after treatment: neurotrophic factor (NTF), nerve growth factor (NGF), neuron specific enolase (NSE); content of CXC chemotactic factor ligand 16 (CXCL16), soluble CD ligand (CD40L), Fibulin-5 and high mobility group box B1 (HMGB1); the content of indicators of vascular endothelial function including plasma endothelin -1 (ET-1) and no therapeutic effects and adverse effects were recorded. Results: NSE of both groups after treatment decreased obviously, and the content of NTF and NGF increased obviously. NSE content of observation group was lower than that of control group. NTF content and NGF content of observation group were higher than those of control group. The differences had statistical significance ( p < 0.05). The levels of CXCL16, CD40L, Fibulin-5 and HMGB1 declined obviously, compared with pre-treatment, and the levels of observation groups were significantly lower than those of control grip. The differences had statistical significance ( p < 0.05). ET-1 level rose significantly after treatment, and NO level declined obviously after treatment. ET-1 level of observation group was significantly higher than that of control group, and NO level of observation group was significantly lower than that of control group. The difference had statistical significance ( p < 0.05). Clinical effect of observation group was significantly higher than that of control group. The difference had statistical significance ( p < 0.05). The comparison difference of both groups in the occurrence rate of adverse effects had no statistical significance ( p > 0.05). Conclusion: The application of butyphthalide combined with urinary kallikrein in ACI treatment can effectively inhibit secretion and release of neuro-cytokines, and improve patients' vascular endothelial function, with significant treatment effect and high safety. Therefore, it deserves to be promoted clinically.",2021,The comparison difference of both groups in the occurrence rate of adverse effects had no statistical significance (P > 0.05).,"['110 ACI patients', 'acute cerebral infarction (ACI']","['Butyphthalide Combined with Urinary Kallikrein', 'Butyphthalide injection combined with urinary kallikrein', 'butyphthalide combined with urinary kallikrein', 'cinepazide maleate injection combined with alprostadil injection']","['neurotrophic factor (NTF), nerve growth factor (NGF), neuron specific enolase (NSE); content of CXC chemotactic factor ligand 16 (CXCL16), soluble CD ligand (CD40L), Fibulin-5 and high mobility group box B1 (HMGB1); the content of indicators of vascular endothelial function including plasma endothelin -1 (ET-1) and no therapeutic effects and adverse effects', 'Neuro-cytokines and Vascular Endothelial Function', 'levels of CXCL16, CD40L, Fibulin-5 and HMGB1', 'content of NTF and NGF', 'NTF content and NGF content', 'ET-1 level']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0540404', 'cui_str': 'adenylyl cyclase type I'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0752224', 'cui_str': 'Human Glandular Kallikrein 1'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0055741', 'cui_str': '1-((1-pyrrolidynylcarbonyl)methyl)-4-(3,4,5-trimethoxycinnamoyl)piperazine maleate'}, {'cui': 'C4056662', 'cui_str': 'Alprostadil Injection [Caverject]'}]","[{'cui': 'C0027754', 'cui_str': 'Neurotrophic Factors'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C1880904', 'cui_str': 'Nervous System-Specific Enolase'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0008013', 'cui_str': 'Chemotaxins'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0060380', 'cui_str': 'fibulin'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C1527144'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0167627', 'cui_str': 'T-B Cell Activating Molecule'}, {'cui': 'C0019796', 'cui_str': 'Heparin-Binding Protein p30'}]",110.0,0.0186908,The comparison difference of both groups in the occurrence rate of adverse effects had no statistical significance (P > 0.05).,"[{'ForeName': 'Wenqin', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Department of Neurology, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, P.R. China.'}, {'ForeName': 'Yanqing', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Department of Neurology, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, P.R. China.'}, {'ForeName': 'Guanghui', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, P.R. China.'}, {'ForeName': 'Shouqin', 'Initials': 'S', 'LastName': 'Shangguan', 'Affiliation': 'Department of Neurology, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, P.R. China.'}, {'ForeName': 'Faming', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, P.R. China.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, P.R. China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Renmin Hospital, Hubei University of Medicine, Shiyan, Hubei, P.R. China.'}]",The International journal of neuroscience,['10.1080/00207454.2020.1732972']
3182,32113660,"Re: Robert A. Huddart, Emma Hall, Rebecca Lewis, et al. Patient-reported Quality of Life Outcomes in Patients Treated for Muscle-invasive Bladder Cancer with Radiotherapy ± Chemotherapy in the BC2001 Phase III Randomised Controlled Trial. Eur Urol 2020;77:260-8.",,2020,,['Patients Treated for Muscle-invasive Bladder Cancer with'],['Radiotherapy ± Chemotherapy'],['Quality of Life Outcomes'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[{'cui': 'C0034380'}],,0.109066,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Zhongnan Hospital of Wuhan University, Wuhan, China; Department of Biological Repositories, Zhongnan Hospital of Wuhan University, Wuhan, China. Electronic address: lisheng-znyy@whu.edu.cn.'}]",European urology,['10.1016/j.eururo.2020.02.014']
3183,31902378,"The effects of n -3 fatty acids from flaxseed oil on genetic and metabolic profiles in patients with gestational diabetes mellitus: a randomised, double-blind, placebo-controlled trial.","The present study was performed to evaluate the effects of n-3 fatty acids from flaxseed oil on genetic and metabolic profiles in patients with gestational diabetes mellitus (GDM). This randomised, double-blind, placebo-controlled clinical trial was performed in sixty women with GDM. Participants were randomly divided into two groups to intake either 2 × 1000 mg/d n-3 fatty acids from flaxseed oil containing 400 mg α-linolenic acid in each capsule (n 30) or placebo (n 30) for 6 weeks. n-3 Fatty acid intake up-regulated PPAR-γ (P < 0·001) and LDL receptor (P = 0·004) and down-regulated gene expression of IL-1 (P = 0·002) and TNF-α (P = 0·001) in peripheral blood mononuclear cells of subjects with GDM. In addition, n-3 fatty acid supplementation reduced fasting plasma glucose (P = 0·001), insulin levels (P = 0·001) and insulin resistance (P < 0·001) and increased insulin sensitivity (P = 0·005) when compared with the placebo. Additionally, n-3 fatty acid supplementation was associated with a decrease in TAG (P < 0·001), VLDL-cholesterol (P < 0·001), total cholesterol (P = 0·01) and total cholesterol:HDL-cholesterol ratio (P = 0·01) when compared with placebo. n-3 Fatty acid administration was also associated with a significant reduction in high-sensitivity C-reactive protein (P = 0·006) and malondialdehyde (P < 0·001), and an increase in total nitrite (P < 0·001) and total glutathione levels (P = 0·006) when compared with the placebo. n-3 Fatty acid supplementation for 6 weeks to women with GDM had beneficial effects on gene expression related to insulin, lipid and inflammation, glycaemic control, lipids, inflammatory markers and oxidative stress.",2020,"Omega-3 fatty acids intake upregulated peroxisome proliferator-activated receptor gamma (P<0.001) and low-density lipoprotein receptor (P=0.004), and downregulated gene expression of interleukin-1 (P=0.002) and tumor necrosis factor alpha (P=0.001) in peripheral blood mononuclear cells of subjects with GDM.","['60 women with GDM', 'patients with gestational diabetes mellitus (GDM', 'patients with gestational diabetes mellitus']","['omega-3 fatty acids from flaxseed oil', 'placebo', 'intake either 2 x 1,000 mg/day omega-3 fatty acids from flaxseed oil containing 400 mg α-linolenic acid in each capsule (n=30) or placebo', 'Omega-3 fatty acids', 'omega-3 fatty acids supplementation', 'Omega-3 fatty acids supplementation']","['fasting plasma glucose', 'total-/HDL-cholesterol ratio', 'insulin levels', 'insulin sensitivity', 'high sensitivity C-reactive protein', 'triglycerides (P<0.001), VLDL-cholesterol (P<0.001), total cholesterol', 'insulin resistance', 'total nitrite (P<0.001) and total glutathione levels', 'insulin, lipid and inflammation, glycemic control, lipids, inflammatory markers and oxidative stress']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023754', 'cui_str': 'flaxseed oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",60.0,0.476656,"Omega-3 fatty acids intake upregulated peroxisome proliferator-activated receptor gamma (P<0.001) and low-density lipoprotein receptor (P=0.004), and downregulated gene expression of interleukin-1 (P=0.002) and tumor necrosis factor alpha (P=0.001) in peripheral blood mononuclear cells of subjects with GDM.","[{'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Jamilian', 'Affiliation': 'Traditional and Complementary Medicine Research Center, Arak University of Medical Sciences, PO Box 3848176941, Arak, Iran.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Tabassi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Reiner', 'Affiliation': 'Department of Internal Medicine, University Hospital Centre Zagreb, School of Medicine, University of Zagreb, 10-000Zagreb, Croatia.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Panahandeh', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Naderi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavod', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Taghizadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Satari', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Mansournia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, PO Box 1417613151, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Memarzadeh', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, PO Box 81151-87159, Kashan, Iran.'}]",The British journal of nutrition,['10.1017/S0007114519003416']
3184,31400513,Targeting pregnancy-related weight gain to reduce disparities in obesity: Baseline results from the Healthy Babies trial.,"BACKGROUND
Obesity affects African American women more than any other group in the US. Pregnancy represents a critical life stage of heightened vulnerability for new or persistent obesity, yet few interventions have been effective in reducing excessive gestational weight gain among African American women. We describe the design and baseline findings of Healthy Babies, a two-arm randomized controlled trial testing a mobile health intervention to minimize excessive gestational weight gain versus usual care in this high risk group.
METHODS
African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics. Participants randomized to the intervention received behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group. Data collection included baseline (<22 weeks' gestation), 36-38 weeks' gestation, and 6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets. The primary outcome was prevalence of excessive gestational weight gain.
RESULTS
Among participants at baseline (n = 262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6 ± 5.4 years old with a gestational age of 13.9 ± 4.1 weeks. While 82% completed high school, 61% met criteria for inadequate health literacy. Nearly 20% were food insecure. Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines. There were no significant differences in baseline characteristics between study arms.
CONCLUSIONS
Participants represent a high-risk group for excessive gestational weight gain with demonstrated need for intervention.",2019,"There were no significant differences in baseline characteristics between study arms.
","['African American women', 'Healthy Babies trial', ""African American women in early pregnancy were recruited from two large obstetric practices as well as Philadelphia Women, Infants, and Children's clinics"", 'Healthy Babies', 'Eighty-eight percent reported a gestational weight gain goal discordant with Institute of Medicine guidelines', 'participants at baseline (n\u202f=\u202f262), the majority met criteria for obesity (63%), were multiparous (62%), single (77%), and were on average 25.6\u202f±\u202f5.4\u202fyears old with a gestational age of 13.9\u202f±\u202f4.1\u202fweeks']","['mobile health intervention to minimize excessive gestational weight gain versus usual care', 'behavior change goals, daily text messages with feedback, web-based weight gain graphs, health coaching, and a Facebook support group']","['6-month postpartum anthropometric measures and assessments of demographics, contextual factors and behavioral targets', 'excessive gestational weight gain', 'prevalence of excessive gestational weight gain']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0021621', 'cui_str': 'National Academies of Science, Engineering, and Medicine (US) Health and Medicine Division'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026751', 'cui_str': 'Multiparity'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517562', 'cui_str': '13.9 (qualifier value)'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.278138,"There were no significant differences in baseline characteristics between study arms.
","[{'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America; Department of Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America. Electronic address: herris01@temple.edu.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Albert', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Niesha', 'Initials': 'N', 'LastName': 'Darden', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Bailer', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Cruice', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Sarmina', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Bennett', 'Affiliation': 'Department of Psychology and Neuroscience, Duke University, Durham, NC, United States of America; Duke Digital Health Science Center, Duke Global Health Institute, Durham, NC, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Goetzl', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Center at Houston, Houston, TX, United States of America.'}, {'ForeName': 'Daohai', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, United States of America.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Kilby', 'Affiliation': 'Philadelphia Women, Infants and Children Program, Philadelphia, PA, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Center for Obesity Research and Education, College of Public Health, Temple University, Philadelphia, PA, United States of America; Center for Weight and Eating Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States of America; Weight Watchers International, New York, NY, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105822']
3185,31473172,Higher-Order Assessment of OCT in Diabetic Macular Edema from the VISTA Study: Ellipsoid Zone Dynamics and the Retinal Fluid Index.,"PURPOSE
To investigate retinal fluid features and ellipsoid zone (EZ) integrity dynamics on spectral-domain OCT (SD-OCT) in eyes with diabetic macular edema (DME) treated with intravitreal aflibercept injection (IAI) in the VISTA-DME study.
DESIGN
A post hoc subanalysis of a phase III, prospective clinical trial.
PARTICIPANTS
Eyes received either IAI 2 mg every 4 weeks (2q4) or every 8 weeks after 5 initial monthly doses (2q8).
METHODS
All eyes from the VISTA Phase III study in the IAI groups imaged with the Cirrus HD-OCT system (Zeiss, Oberkochen, Germany) were included. The OCT macular cube datasets were evaluated using a novel software platform to generate retinal layer and fluid boundary lines that were manually corrected for assessment of change in EZ parameters and volumetric fluid parameters from baseline. The retinal fluid index (i.e., proportion of the retinal volume consisting of cystic fluid) was also calculated at each time point.
MAIN OUTCOME MEASURES
The feasibility of volumetric assessment of higher-order OCT-based retinal parameters and its correlation with best-corrected visual acuity (BCVA).
RESULTS
Overall, 106 eyes of 106 patients were included. Specifically, 52 eyes of 52 patients were included in the IAI 2q4 arm, and 54 eyes of 54 patients were included in the IAI 2q8 arm. Ellipsoid zone integrity metrics significantly improved from baseline to week 100, including central macular mean EZ to retinal pigment epithelium (RPE) thickness (2q4: 26.6 μm to 31.6 μm, P < 0.001; 2q8: 25.2 μm to 31.4 μm, P < 0.001). At week 100, central macular intraretinal fluid volume was reduced by >65% (P < 0.001) and central macular subretinal fluid volume was reduced by >99% in both arms (P < 0.001). Central macular retinal fluid index (RFI) significantly improved in both arms (2q4: 17.9% to 7.2%, P < 0.001; 2q8: 19.8% to 4.2%, P < 0.001). Central macular mean EZ-RPE thickness (i.e., a surrogate for photoreceptor outer segment length) and central RFI were independently correlated with BCVA at multiple follow-up visits.
CONCLUSIONS
Intravitreal aflibercept injection resulted in significant improvement in EZ integrity and quantitative fluid metrics in both 2q4 and 2q8 arms and correlated with visual function.",2019,"At week 100, central macular intraretinal fluid volume was reduced by >65% (P < 0.001) and central macular subretinal fluid volume was reduced by >99% in both arms (P < 0.001).","['Diabetic Macular Edema from the VISTA Study', '106 eyes of 106 patients were included', 'eyes with diabetic macular edema (DME', '52 eyes of 52 patients were included in the IAI 2q4 arm, and 54 eyes of 54 patients were included in the IAI 2q8 arm']","['intravitreal aflibercept injection (IAI', 'OCT']","['central macular mean EZ to retinal pigment epithelium (RPE) thickness ', 'Central macular mean EZ-RPE thickness', 'visual function', 'Ellipsoid zone integrity metrics', 'central macular subretinal fluid volume', 'central macular intraretinal fluid volume', 'Central macular retinal fluid index (RFI', 'EZ integrity and quantitative fluid metrics', 'retinal fluid index']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035322', 'cui_str': 'Retinal Pigment Epithelium'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1947912', 'cui_str': 'Integrity (attribute)'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",106.0,0.0701755,"At week 100, central macular intraretinal fluid volume was reduced by >65% (P < 0.001) and central macular subretinal fluid volume was reduced by >99% in both arms (P < 0.001).","[{'ForeName': 'Justis P', 'Initials': 'JP', 'LastName': 'Ehlers', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: ehlersj@ccf.org.'}, {'ForeName': 'Atsuro', 'Initials': 'A', 'LastName': 'Uchida', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Figueiredo', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Kaiser', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Heier', 'Affiliation': 'Ophthalmic Consultants of Boston, Boston, Massachusetts.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Boyer', 'Affiliation': 'Retinal-Vitreous Associates, Los Angeles, California.'}, {'ForeName': 'Diana V', 'Initials': 'DV', 'LastName': 'Do', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gibson', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Saroj', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Srivastava', 'Affiliation': 'The Tony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}]",Ophthalmology. Retina,['10.1016/j.oret.2019.06.010']
3186,32102033,Trabeculectomy With Extended Subscleral Tunnel Versus Conventional Trabeculectomy in the Management of POAG: A 1-Year Randomized-controlled Trial.,"PRECIS
This clinical trial compares a modified trabeculectomy technique [extended subscleral tunnel (ESST)] with conventional trabeculectomy [subscleral trabeculectomy (SST)] in terms of success rate and bleb morphology. ESST showed comparable results, with lower incidence of bleb-related complications and need for postoperative antiglaucoma medications.
BACKGROUND
To evaluate the outcome of modified trabeculectomy with extended subscleral tunnel ""ESST"" versus conventional subscleral trabeculectomy ""SST"" in the management of uncontrolled primary open-angle glaucoma.
PARTICIPANTS AND METHODS
This is a randomized clinical trial of 40 eyes (40 patients) divided into 2 equal groups. In the first group, a conventional SST with adjuvant 0.3% mitomycin-C was performed. In the second group, the ESST group, an additional 1.00 mm wide longitudinal scleral groove was dissected and excised in the center of the deep scleral bed extending 1.00 mm beyond the posterior margin of the flap. Patients were examined on days 1, 7, 14, 30, 90, 180, and at 1 year, with a special focus on intraocular pressure and bleb morphology. Postoperative ultrasound biomicroscopy was performed to evaluate the surgical area.
RESULTS
Both groups showed a significant reduction in intraocular pressure, with the ESST group showing significantly lower values on days 7, 14, 30, 90, and 180 (P=0.001, 0.004, 0.026, 0.001, and 0.048), but no significant differences on day 1 and at 1 year (P=0.06 and 0.07). The need for postoperative antiglaucoma medications was significantly lower in the ESST group (P=0.043). Visually significant cataract and bleb related complications were more in the SST group (P=0.044 and <0.001). Significantly more eyes in the ESST group showed normal bleb vascularity and wider extent.
CONCLUSIONS
ESST offers a guarded posterior flow with a success rate comparable to that of conventional SST. ESST could minimize bleb-related complications and bleb-dysesthesia with better long-term bleb morphology and vascularity. It could also minimize the need for further adjuvant postoperative antiglaucoma medications.",2020,"Both groups showed significant reduction in IOP with the ESST group showing significantly lower values on days 7,14,30,90 and 180 (P=0.001,0.004,0.026, 0.001,0.048) but no significant differences on day 1 and at 1 year (P=0.06,0.07).",['40 eyes (40 patients) divided into 2 equal groups'],"['Postoperative ultrasound biomicroscopy', 'conventional trabeculectomy (SST', 'modified trabeculectomy technique (ESST', 'modified trabeculectomy with extended subscleral tunnel ""ESST"" versus conventional subscleral trabeculectomy ""SST', 'conventional SST with adjuvant 0.3% mitomycin-C', 'Trabeculectomy with Extended Subscleral Tunnel versus Conventional Trabeculectomy', 'ESST']","['postoperative anti-glaucoma medications', 'Visually significant cataract and bleb related complications', 'normal bleb vascularity and wider extent', 'IOP', 'intraocular pressure (IOP) and bleb morphology']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1301497', 'cui_str': 'Ultrasound Biomicroscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C3714607', 'cui_str': 'Filtering bleb'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0543482', 'cui_str': 'morphology'}]",,0.0560337,"Both groups showed significant reduction in IOP with the ESST group showing significantly lower values on days 7,14,30,90 and 180 (P=0.001,0.004,0.026, 0.001,0.048) but no significant differences on day 1 and at 1 year (P=0.06,0.07).","[{'ForeName': 'Riham S H M', 'Initials': 'RSHM', 'LastName': 'Allam', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Karim A', 'Initials': 'KA', 'LastName': 'Raafat', 'Affiliation': ''}, {'ForeName': 'Rehab M', 'Initials': 'RM', 'LastName': 'Abdel-Hamid', 'Affiliation': ''}]",Journal of glaucoma,['10.1097/IJG.0000000000001480']
3187,31396891,Influence of Postoperative Posture on Macular Slippage after Macula-Off Retinal Detachment: A Randomized Controlled Trial.,"INTRODUCTION
To evaluate the effect of postoperative posture on the retinal shift after retinal detachment repair.
METHODS
Patients who underwent pars plana vitrectomy (PPV) for macula-off rhegmatogenous retinal detachment (RRD) were included prospectively in the current study. Patients were randomized into two groups: group A included patients who did a log roll postoperatively, and group B included patients who had to lie flat on their backs for 6 h postoperatively before moving into the end position. Patients in group A and patients in group B were reviewed after 3 weeks and after 6 weeks, respectively, and fundus autofluorescence images (FAF) were obtained to visualize the retinal rotation.
RESULTS
The sample included 50 eyes from 49 patients. Retinal shift occurred after RRD repair in 17 patients (34%). There was no statistically significant difference between the two groups (p = 0.94). Postoperative macular shift occurred significantly less often (p = 0.049) in participants in whom heavy fluid was used in the procedure. Metamorphopsia was reported postoperatively by 10 of 17 patients with retinal shift (p < 0.001).
CONCLUSION
In our study, postoperative posture did not significantly influence postoperative macular slippage after RRD repair. The use of intraoperative heavy liquid appears to be associated with a lower occurrence of retinal shift.",2019,Postoperative macular shift occurred significantly less often (p = 0.049) in participants in whom heavy fluid was used in the procedure.,"['for macula-off rhegmatogenous retinal detachment (RRD', 'Patients who underwent', 'Macular Slippage after Macula-Off Retinal Detachment', 'The sample included 50 eyes from 49 patients']","['Postoperative Posture', 'postoperative posture', 'pars plana vitrectomy (PPV']","['Metamorphopsia', 'Retinal shift', 'Postoperative macular shift']","[{'cui': 'C0332573', 'cui_str': 'Macule (morphologic abnormality)'}, {'cui': 'C0271055', 'cui_str': 'Rhegmatogenous retinal detachment (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035305', 'cui_str': 'Retinal Detachment'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C0271185', 'cui_str': 'Metamorphopsia'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",50.0,0.053386,Postoperative macular shift occurred significantly less often (p = 0.049) in participants in whom heavy fluid was used in the procedure.,"[{'ForeName': 'Megir', 'Initials': 'M', 'LastName': 'Schawkat', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Valmaggia', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Hendrik P N', 'Initials': 'HPN', 'LastName': 'Scholl', 'Affiliation': 'Institute of Molecular and Clinical Ophthalmology Basel (IOB), Basel, Switzerland.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Harsum', 'Affiliation': 'Epsom and St Helier University Hospitals, NHS Trust, London, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Guber', 'Affiliation': 'Department of Ophthalmology, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Guber', 'Affiliation': 'Eye Clinic, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland. josef.guber@kssg.ch.'}]",Ophthalmology and therapy,['10.1007/s40123-019-0204-8']
3188,32075641,Comparative value of a simulation by gaming and a traditional teaching method to improve clinical reasoning skills necessary to detect patient deterioration: a randomized study in nursing students.,"BACKGROUND
Early detection and response to patient deterioration influence patient prognosis. Nursing education is therefore essential. The objective of this randomized controlled trial was to compare the respective educational value of simulation by gaming (SG) and a traditional teaching (TT) method to improve clinical reasoning (CR) skills necessary to detect patient deterioration.
METHODS
In a prospective multicenter study, and after consent, 2nd year nursing students were randomized into two groups: Simulation by gaming ""SG"": the student played individually with a serious game consisting of 2 cases followed by a common debriefing with an instructor;Traditional Teaching ""TT"": the student worked on the same cases in text paper format followed by a traditional teaching course with a PowerPoint presentation by an instructor. CR skill was measured by script concordance tests (80 SCTs, score 0-100) immediately after the session (primary outcome) and on month later. Other outcomes included students' satisfaction, motivation and professional impact.
RESULTS
One hundred forty-six students were randomized. Immediately after training, the SCTs scores were 59 ± 9 in SG group (n = 73) and 58 ± 8 in TT group (n = 73) (p = 0.43). One month later, the SCTs scores were 59 ± 10 in SG group (n = 65) and 58 ± 8 in TT group (n = 54) (p = 0.77). Global satisfaction and motivation were highly valued in both groups although significantly greater in the SG group (p < 0.05). The students declared that the training course would have a positive professional impact, with no difference between groups.
CONCLUSIONS
In this study assessing nursing student CR to detect patient deterioration, no significant educational difference (SCT), neither immediate nor 1 month later, was observed between training by SG and the TT course. However, satisfaction and motivation were found to be greater with the use of SG.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT03428269. Registered 30 january 2018.",2020,Global satisfaction and motivation were highly valued in both groups although significantly greater in the SG group (p < 0.05).,"['One hundred forty-six students', 'nursing students', '2nd year nursing students']","['Simulation by gaming ""SG"": the student played individually with a serious game consisting of 2 cases followed by a common debriefing with an instructor;Traditional Teaching ""TT', 'simulation by gaming (SG) and a traditional teaching (TT', 'simulation by gaming and a traditional teaching method']","['satisfaction and motivation', 'clinical reasoning (CR) skills', 'SCTs scores', 'Global satisfaction and motivation', ""students' satisfaction, motivation and professional impact"", 'CR skill']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0039403', 'cui_str': 'Teaching Methods'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",146.0,0.047355,Global satisfaction and motivation were highly valued in both groups although significantly greater in the SG group (p < 0.05).,"[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Blanié', 'Affiliation': 'Centre de simulation LabForSIMS, Faculté de médecine Paris Saclay, 94275, Le Kremlin Bicêtre, France. antonia.blanie@aphp.fr.'}, {'ForeName': 'Michel-Ange', 'Initials': 'MA', 'LastName': 'Amorim', 'Affiliation': 'CIAMS, Univ. Paris-Sud, Université Paris-Saclay, 91405, Orsay, Cedex, France.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Benhamou', 'Affiliation': 'Centre de simulation LabForSIMS, Faculté de médecine Paris Saclay, 94275, Le Kremlin Bicêtre, France.'}]",BMC medical education,['10.1186/s12909-020-1939-6']
3189,31387822,Impact of telephone follow-up and 24/7 hotline on 30-day readmission rates following aortic valve replacement -A randomized controlled trial.,"BACKGROUND
Thirty-day all-cause readmissions are high after aortic valve replacement (AVR). We aimed to assess the effectiveness of a structured telephone follow-up (TFU) and a 24/7 hotline on reducing 30-day all-cause readmission (30-DACR) after AVR, on reducing symptoms of anxiety and depression and on improving perceived health state.
METHODS
A prospective randomized controlled trial was conducted. Patients (n = 288) were randomly allocated to either post-discharge usual care or to care that provided TFU and access to a 24/7 hotline after AVR. Ancillary endpoints were time-to-event (readmission), proportion of avoidable versus unavoidable readmissions after AVR, and predictors of 30-DACR after AVR.
RESULTS
30-DACR was 22.3%. The structured TFU and 24/7 hotline intervention failed to reduce 30-DACR rates after AVR (P = 0.274). Symptoms of anxiety were significantly reduced 30 days after surgery (P = 0.031), an effect that did not persist one year after surgery (P = 0.108). Most readmissions occurred before 15 days post-discharge, and 75% of them were deemed to be unavoidable. Pleural drainage before hospital discharge (P = 0.027) and symptoms of anxiety before surgery (P = 0.003) were predictors of 30-DACR after AVR.
CONCLUSION
The TFU and 24/7 hotline had no effect on reducing 30-DACR after AVR. However, we did measure reduced symptoms of anxiety the first month after AVR. Anxiety reduction appeared to be an important target for intervention, because we found it to be a risk factor for readmission. Future research should focus on the effectiveness of interventions to prevent avoidable unplanned readmissions.
TRIAL REGISTRATION
ClinicalTrial.gov, NCT02522663.",2020,"Symptoms of anxiety were significantly reduced 30 days after surgery (P = 0.031), an effect that did not persist one year after surgery (P = 0.108).",['Patients (n\u202f=\u202f288'],"['post-discharge usual care or to care that provided TFU and access to a 24/7 hotline after AVR', 'structured telephone follow-up (TFU', 'telephone follow-up and 24/7 hotline']","['Pleural drainage before hospital discharge', 'Symptoms of anxiety', '30-DACR rates', 'time-to-event (readmission), proportion of avoidable versus unavoidable readmissions after AVR, and predictors of 30-DACR after AVR', '30-day readmission rates', '30-DACR', 'symptoms of anxiety', 'Anxiety reduction', 'symptoms of anxiety before surgery', '30-day all-cause readmission (30-DACR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]","[{'cui': 'C1522720', 'cui_str': 'Pleural (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449217', 'cui_str': 'aVR (body structure)'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",288.0,0.0654353,"Symptoms of anxiety were significantly reduced 30 days after surgery (P = 0.031), an effect that did not persist one year after surgery (P = 0.108).","[{'ForeName': 'Stein Ove', 'Initials': 'SO', 'LastName': 'Danielsen', 'Affiliation': 'Center for Patient-centered Heart and Lung Research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; KU Leuven Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium. Electronic address: steinda@uio.no.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Moons', 'Affiliation': 'KU Leuven Department of Public Health and Primary Care, KU Leuven-University of Leuven, Leuven, Belgium; Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden; Department of Paediatrics and Child Health, University of Cape Town, South Africa.'}, {'ForeName': 'Leiv', 'Initials': 'L', 'LastName': 'Sandvik', 'Affiliation': 'Oslo Centre of Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Leegaard', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Solheim', 'Affiliation': 'Center for Clinical Heart Research, Department of Cardiology, Division of Medicine, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Theis', 'Initials': 'T', 'LastName': 'Tønnessen', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo, Norway.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Lie', 'Affiliation': 'Center for Patient-centered Heart and Lung Research, Department of Cardiothoracic Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Ullevål, Oslo, Norway.'}]",International journal of cardiology,['10.1016/j.ijcard.2019.07.087']
3190,32003150,"Efficacy and safety of dapagliflozin plus saxagliptin versus insulin glargine over 52 weeks as add-on to metformin with or without sulphonylurea in patients with type 2 diabetes: A randomized, parallel-design, open-label, Phase 3 trial.","AIM
Efficacy and safety of dapagliflozin plus saxagliptin (DAPA + SAXA) were compared with insulin glargine (INS) in patients with type 2 diabetes (T2D) in a 52-week extension study.
MATERIALS AND METHODS
This international Phase 3 study randomized adults with T2D on metformin with/without sulphonylurea. They received DAPA + SAXA or INS for 24 weeks (short-term) with a 28-week (long-term) extension. Week 52 exploratory endpoints included adjusted mean change from baseline in glycated haemoglobin A 1c (HbA1c) and body weight, and a proportion of patients achieving optimal glycaemic response without hypoglycaemia and without requiring rescue medication.
RESULTS
Of the 1163 patients enrolled, 643 received treatment; 600 (DAPA + SAXA, 306; INS, 294) entered the long-term phase. At 52 weeks, HbA1c [adjusted least squares (LS) mean; 95% confidence interval (CI)] decreased more with DAPA + SAXA (-1.5% [-1.6%, -1.4%]) than with INS (-1.3% [-1.4%, -1.1%]); the LS mean difference (95% CI) was -0.25% (-0.4%, -0.1%; P = 0.009). Total body weight reduced with DAPA + SAXA [LS mean (95% CI): -1.8 kg (-2.4, -1.3)] and increased with INS [LS mean (95% CI): +2.8 kg (2.2, 3.3)]. More patients on DAPA + SAXA (17.6%) achieved HbA1c <7.0% without hypoglycaemia versus those on INS (9.1%). Rescue medication was required by 77 patients (23.8%) and 97 patients (30.4%) in the DAPA + SAXA and INS groups, respectively.
CONCLUSION
DAPA + SAXA treatment was non-inferior to INS in reducing HbA1c and body weight, and in achieving optimal glycaemic control without hypoglycaemia in patients with T2D 52 weeks after initiation.",2020,"Total body weight reduced with DAPA+SAXA (LS mean [95% CI]: -1.8 kg [-2.4, -1.3]) and increased with INS (LS mean [95% CI]: +2.8 kg [2.2, 3.3]).","['patients with type 2 diabetes (T2D) in this 52-week extension study', '1,163 patients enrolled, 643 received treatment; 600 (DAPA+SAXA, 306; INS, 294) entered the long-term phase', 'adults with T2D on', 'patients with type 2 diabetes']","['metformin with/without sulfonylurea received DAPA+SAXA or INS', 'DAPA+SAXA', 'dapagliflozin plus saxagliptin', 'insulin glargine (INS', 'insulin glargine', 'dapagliflozin plus saxagliptin (DAPA+SAXA', 'metformin with or without sulfonylurea']","['DAPA+SAXA', 'Rescue medication', 'Efficacy and safety', 'Total body weight', 'adjusted mean change from baseline in HbA 1c and body weight, and proportion of patients achieving optimal glycemic response without hypoglycemia and without requiring rescue medication', 'HbA 1c and body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",1163.0,0.153635,"Total body weight reduced with DAPA+SAXA (LS mean [95% CI]: -1.8 kg [-2.4, -1.3]) and increased with INS (LS mean [95% CI]: +2.8 kg [2.2, 3.3]).","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Ekholm', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, New, Jersey.'}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Institute of Medicine, University of Gothenburg and Department of Medicine, NU-Hospital Group, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13981']
3191,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND
Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS
We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10 viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS
Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION
Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING
Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3192,32087001,Pharmacokinetics of Cenobamate: Results From Single and Multiple Oral Ascending-Dose Studies in Healthy Subjects.,"Cenobamate (YKP3089) is an antiepileptic drug recently approved by the Food and Drug Administration for the treatment of focal (partial-onset) seizures in adults. The objectives of a first-in-human single-ascending-dose study and 3 multiple-ascending-dose studies were to characterize the pharmacokinetics, safety, and tolerability of cenobamate after single-dose and multiple-dose administration in healthy subjects. The 4 randomized, placebo-controlled, double-blind studies were conducted in 210 healthy subjects receiving single (5 to 750 mg) or multiple (50 to 600 mg/day) oral doses of cenobamate or placebo using capsule formulation. Safety assessments included treatment-emergent adverse events (TEAEs) and laboratory evaluations. Maximum plasma concentrations of cenobamate were observed between 0.8 and 4.0 hours after oral administration. C max increased in a dose-proportional manner for single- and multiple-dose administration across all tested doses. Although the AUC of cenobamate increased in a more than dose-proportional manner after single-dose administration, a dose-proportional increase in cenobamate AUC τ was observed after multiple dosing from 50 to 500 mg/day. Cenobamate exhibited low oral clearance (decreasing from approximately 1.4 to 0.50 L/h with dose increase) and long terminal half-life (range, approximately 30 to 76 hours with increasing dose). Steady-state was attained after approximately 2 weeks, and the accumulation ratio was approximately 5 over the 50 to 300 mg/day range. The pharmacokinetic characteristics of cenobamate are consistent with once-daily dosing. Most TEAEs were mild in severity, 2 serious TEAEs were reported, and no deaths occurred across all studies. Except for multiple daily doses of 600 mg, all doses were generally well tolerated.",2020,"Cenobamate exhibited low oral clearance (decreasing from approximately 1.4 to 0.50 L/h with dose increase) and long terminal half-life (range, approximately 30 to 76 hours with increasing dose).","['Healthy Subjects', 'focal (partial-onset) seizures in adults', '210 healthy subjects receiving single (5\xa0to 750\xa0mg) or multiple (50\xa0to 600\xa0mg/day) oral doses of', 'healthy subjects']","['placebo', 'Cenobamate (YKP3089', 'cenobamate or placebo', 'Cenobamate']","['cenobamate AUC τ', 'Steady-state', 'low oral clearance', 'tolerated', 'pharmacokinetics, safety, and tolerability of cenobamate', 'Maximum plasma concentrations of cenobamate', 'Safety assessments included treatment-emergent adverse events (TEAEs) and laboratory evaluations', 'C max', 'accumulation ratio']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",210.0,0.0923336,"Cenobamate exhibited low oral clearance (decreasing from approximately 1.4 to 0.50 L/h with dose increase) and long terminal half-life (range, approximately 30 to 76 hours with increasing dose).","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Vernillet', 'Affiliation': 'SK Life Science, Inc., Paramus, New Jersey, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Greene', 'Affiliation': 'SK Life Science, Inc., Paramus, New Jersey, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'SK Life Science, Inc., Paramus, New Jersey, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.769']
3193,31375873,Concomitant transobturator tape and anterior colporrhaphy versus transobturator subvesical mesh for cystocele-associated stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS
Stress urinary incontinence (SUI) and cystocele often occur concomitantly and thus may potentially be treated via a single surgical procedure. This study evaluated the efficacy and safety of concomitant transobturator tape (TOT) with anterior colporrhaphy versus subvesical transobturator mesh (TOM) for cystocele-associated SUI.
METHODS
This prospective, clinical trial included women with cystocele-associated SUI. Patients were randomly allocated into either group I (anterior colporrhaphy with concomitant TOT ""in-out"" fixation) or group II (implantation of a subvesical four-armed TOM). All patients were followed up at 1, 3, 6, 9, and 12 months postoperatively. Statistical tests were performed to compare the group outcomes based on objective, subjective, and anatomical variables.
RESULTS
There were 81 patients in group I and 83 in group II. Median follow-up duration was 12 months. The demographic data and baseline clinical characteristics of both groups were comparable. There were no significant differences between groups regarding the success rates of SUI and cystocele repair. Groups I and II had similar cure rates of SUI (82.9 and 88.4%, respectively; p = 0.369) and incidences of successful cystocele repair (85.4 and 97.7%, respectively; p = 0.055). No urethral or bladder injuries or mesh erosions were reported. Both groups had comparable postoperative complications, except the greater incidence of micturition difficulty in group I than group II, during the early follow-up (12.2% vs. 0.0%; p = 0.024).
CONCLUSIONS
Transvaginal mesh was not superior to native tissue repair. Anterior colporrhaphy and TOT may be an appropriate alternative to four-armed TOM application for concomitant correction of SUI and cystocele.",2020,"Both groups had comparable postoperative complications, except the greater incidence of micturition difficulty in group I than group II, during the early follow-up (12.2% vs. 0.0%; p = 0.024).
",['women with cystocele-associated SUI'],"['Anterior colporrhaphy and TOT', 'Concomitant transobturator tape and anterior colporrhaphy versus transobturator subvesical mesh', 'concomitant transobturator tape (TOT) with anterior colporrhaphy versus subvesical transobturator mesh (TOM', 'group I (anterior colporrhaphy with concomitant TOT ""in-out"" fixation) or group II (implantation of a subvesical four-armed TOM']","['postoperative complications', 'incidence of micturition difficulty', 'success rates of SUI and cystocele repair', 'objective, subjective, and anatomical variables', 'incidences of successful cystocele repair', 'efficacy and safety', 'cure rates of SUI', 'urethral or bladder injuries or mesh erosions']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1394494', 'cui_str': 'Bladder cystocele'}]","[{'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy (procedure)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1721084', 'cui_str': 'Transobturator Suburethral Tape'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1261300', 'cui_str': 'Repair of cystocele (procedure)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C0403677', 'cui_str': 'Injury of bladder (disorder)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}]",81.0,0.025234,"Both groups had comparable postoperative complications, except the greater incidence of micturition difficulty in group I than group II, during the early follow-up (12.2% vs. 0.0%; p = 0.024).
","[{'ForeName': 'Abul-Fotouh A', 'Initials': 'AA', 'LastName': 'Ahmed', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt. abulfotouhahmed@yahoo.com.'}, {'ForeName': 'Ashraf H', 'Initials': 'AH', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Hesham A', 'Initials': 'HA', 'LastName': 'El-Helaly', 'Affiliation': 'Department of Urology, Faculty of Medicine, Fayoum University, Fayoum, Egypt.'}, {'ForeName': 'Ibrahim A', 'Initials': 'IA', 'LastName': 'Tagreda', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'El-Feky', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Mohammed M', 'Initials': 'MM', 'LastName': 'Agha', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Ahmed G', 'Initials': 'AG', 'LastName': 'Abdelraouf', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}, {'ForeName': 'Ahmed F', 'Initials': 'AF', 'LastName': 'Abdelrahim', 'Affiliation': 'Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, 11633, Egypt.'}]",International urogynecology journal,['10.1007/s00192-019-04068-8']
3194,32076718,"Cellular Immunity to Predict the Risk of Cytomegalovirus Infection in Kidney Transplantation: A Prospective, Interventional, Multicenter Clinical Trial.","BACKGROUND
Improving cytomegalovirus (CMV) immune-risk stratification in kidney transplantation is highly needed to establish guided preventive strategies.
METHODS
This prospective, interventional, multicenter clinical trial assessed the value of monitoring pretransplant CMV-specific cell-mediated immunity (CMI) using an interferon-γ release assay to predict CMV infection in kidney transplantation. One hundred sixty donor/recipient CMV-seropositive (D+/R+) patients, stratified by their baseline CMV (immediate-early protein 1)-specific CMI risk, were randomized to receive either preemptive or 3-month antiviral prophylaxis. Also, 15-day posttransplant CMI risk stratification and CMI specific to the 65 kDa phosphoprotein (pp65) CMV antigen were investigated. Immunosuppression consisted of basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids in 80% of patients, whereas 20% received thymoglobulin induction therapy.
RESULTS
Patients at high risk for CMV based on pretransplant CMI developed significantly higher CMV infection rates than those deemed to be at low risk with both preemptive (73.3% vs 44.4%; odds ratio [OR], 3.44 [95% confidence interval {CI}, 1.30-9.08]) and prophylaxis (33.3% vs 4.1%; OR, 11.75 [95% CI, 2.31-59.71]) approaches. The predictive capacity for CMV-specific CMI was only found in basiliximab-treated patients for both preemptive and prophylaxis therapy. Fifteen-day CMI risk stratification better predicted CMV infection (81.3% vs 9.1%; OR, 43.33 [95% CI, 7.89-237.96]).
CONCLUSIONS
Pretransplant CMV-specific CMI identifies D+/R+ kidney recipients at high risk of developing CMV infection if not receiving T-cell-depleting antibodies. Monitoring CMV-specific CMI soon after transplantation further defines the CMV infection prediction risk. Monitoring CMV-specific CMI may guide decision making regarding the type of CMV preventive strategy in kidney transplantation.
CLINICAL TRIALS REGISTRATION
NCT02550639.",2020,The predictive capacity for CMV-specific CMI was only found in basiliximab-treated patients for both preemptive and prophylaxis therapy.,"['kidney transplantation', 'One hundred sixty donor/recipient CMV-seropositive (D+/R+) patients, stratified by their baseline CMV (immediate-early protein 1)-specific CMI risk', 'Kidney Transplantation']","['pretransplant CMV-specific cell-mediated immunity (CMI', 'basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids', 'thymoglobulin induction therapy', 'preemptive or 3-month antiviral prophylaxis']","['CMV infection rates', 'CMV infection']","[{'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0206355', 'cui_str': 'Immediate-Early Proteins'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020966', 'cui_str': 'Cell-Mediated Immunity'}, {'cui': 'C0676831', 'cui_str': 'basiliximab'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0730920', 'cui_str': 'Thymoglobulin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0877137', 'cui_str': 'Antiviral prophylaxis'}]","[{'cui': 'C0010823', 'cui_str': 'Salivary Gland Virus Disease'}]",,0.0481627,The predictive capacity for CMV-specific CMI was only found in basiliximab-treated patients for both preemptive and prophylaxis therapy.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Jarque', 'Affiliation': 'Experimental Nephrology Laboratory, Bellvitge Biomedical Research Institute, IDIBELL, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Crespo', 'Affiliation': 'Experimental Nephrology Laboratory, Bellvitge Biomedical Research Institute, IDIBELL, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'Melilli', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Gutiérrez', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Moreso', 'Affiliation': ""Kidney Transplant Unit, Nephrology Department, Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Guirado', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Fundació Puigvert, Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Revuelta', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Montero', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Torras', 'Affiliation': 'Experimental Nephrology Laboratory, Bellvitge Biomedical Research Institute, IDIBELL, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Riera', 'Affiliation': 'Urology Department, Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Meneghini', 'Affiliation': 'Experimental Nephrology Laboratory, Bellvitge Biomedical Research Institute, IDIBELL, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Taco', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Manonelles', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Hospital Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Seron', 'Affiliation': ""Kidney Transplant Unit, Nephrology Department, Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'Carme', 'Initials': 'C', 'LastName': 'Facundo', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Fundació Puigvert, Barcelona, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cruzado', 'Affiliation': 'Experimental Nephrology Laboratory, Bellvitge Biomedical Research Institute, IDIBELL, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Gil Vernet', 'Affiliation': 'Kidney Transplant Unit, Nephrology Department, Bellvitge University Hospital, Barcelona, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Grinyó', 'Affiliation': 'Experimental Nephrology Laboratory, Bellvitge Biomedical Research Institute, IDIBELL, Hospitalet de Llobregat, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Bestard', 'Affiliation': 'Experimental Nephrology Laboratory, Bellvitge Biomedical Research Institute, IDIBELL, Hospitalet de Llobregat, Spain.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1209']
3195,32077301,Effects of Intervention Characteristics on Willingness to Initiate a Weight Gain Prevention Program.,"PURPOSE
To determine characteristics of weight gain prevention programs that facilitate engagement.
DESIGN
Randomized factorial experiment (5 × 2).
SETTING
Recruited nationally online.
PARTICIPANTS
Adults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498).
MEASURES
Participants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only; physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring). Participants reported willingness to join the programs, perceived program effectiveness, and reasons for declining enrollment.
ANALYSIS
Logistic regression and linear regression to test effects of program characteristics offered on willingness to initiate programs and programs' perceived effectiveness, respectively. Content analyses for open-ended text responses.
RESULTS
Participants offered the self-weighing-only programs were more willing to initiate than those offered the programs targeting all 3 behaviors combined (50% vs 36%; odds ratio [OR] = 1.79; 95% confidence interval [CI], 1.01-3.13). Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34, P = .02) than those offered no financial incentives. Reasons for declining to initiate included specific program features, behavior targets, social aspects, and benefits.
CONCLUSION
Targeting self-weighing and providing financial incentives for self-monitoring may result in greater uptake of weight gain prevention programs.
STUDY PREREGISTRATION
https://osf.io/b9zfh, June 19, 2018.",2020,"Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34, P = .02) than those offered no financial incentives.","['Adults aged 18 to 75 with body mass index ≥25 who decline a behavioral weight loss intervention (n = 498', 'Participants were randomly presented with one of 10 possible descriptions of hypothetical, free weight gain prevention programs that were all low dose and technology-based but differed in regard to 5 behavior change targets (self-weighing only; diet only', 'Recruited nationally online', 'https://osf.io/b9zfh , June 19, 2018']","['physical activity only; combined diet, physical activity, and self-weighing; or choice between diet, physical activity, and self-weighing targets) crossed with 2 financial incentive conditions (presence or absence of incentives for self-monitoring']",['intervention effectiveness'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0528058,"Participants offered the programs with financial incentives were more willing to initiate (50% vs 33%; OR = 2.08; 95% CI, 1.44-2.99) and anticipated greater intervention effectiveness (β = .34, P = .02) than those offered no financial incentives.","[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'McVay', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Marissa L', 'Initials': 'ML', 'LastName': 'Donahue', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'JeeWon', 'Initials': 'J', 'LastName': 'Cheong', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bacon', 'Affiliation': 'Department of Health Education and Behavior, College of Health and Human Performance, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120905709']
3196,32074665,"Safety and efficacy of fixed-dose combination calcipotriol (50 μg/g) and betamethasone dipropionate (0.5 mg/g) cutaneous foam in adolescent patients (aged 12 to <17 years) with plaque psoriasis: results of a phase II, open-label trial.","BACKGROUND
Fixed-dose combination of calcipotriol (50 μg/g; Cal) and betamethasone dipropionate (0.5 mg/g; BD) foam is approved for plaque psoriasis treatment in adults, with a paucity of data supporting use in adolescents.
OBJECTIVES
To evaluate safety of 4 weeks' treatment with Cal/BD foam in adolescent patients with psoriasis, and additional safety outcomes in patients with more severe disease (HPA-axis cohort). Primary objectives included treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio in the HPA-axis cohort. Secondary objectives included exploratory efficacy endpoints [treatment success: change in Psoriasis Area and Severity Index (PASI)]. Systemic exposure to Cal/BD was also assessed.
METHODS
A phase II, open-label, study (NCT02387853) in patients (12 to <17 years) with at least mild psoriasis, to evaluate Cal/BD foam applied once daily for ≤4 weeks.
RESULTS
In patients assigned to treatment (n = 106), 32 TEAEs occurred in 22 patients (20.8%). All but two TEAEs were mild; none led to study withdrawal or death. Changes (0-4 weeks) in albumin-corrected serum calcium (overall population) and urinary calcium excretion (HPA-axis cohort) were small, transient and not considered clinically relevant. In the HPA-axis cohort, no change in urinary calcium:creatinine ratio was observed and responses to adrenocorticotropic-hormone (ACTH) challenge did not suggest disruption of the HPA-axis. Prespecified treatment success on the body and scalp was achieved by 71.8% and 75.7% of the overall population, respectively. Mean PASI decreased by 82.0% vs. baseline at Week 4. Systemic exposure to Cal/BD was minimal.
CONCLUSIONS
Cal/BD foam was well tolerated in adolescent patients with body/scalp psoriasis. There was no evidence for dysregulation of the HPA-axis nor calcium homoeostasis in patients with more severe disease. Exploratory efficacy data in the overall population were encouraging.",2020,Mean PASI decreased by 82.0% vs. baseline at Week 4.,"['adolescent patients (aged 12 to <17\xa0years) with plaque psoriasis', 'adolescent patients with body/scalp psoriasis', 'patients with more severe disease', 'adolescent patients with psoriasis, and additional safety outcomes in patients with more severe disease (HPA-axis cohort', 'patients (12 to <17\xa0years) with at least mild psoriasis, to evaluate Cal/BD foam applied once daily for ≤4\xa0weeks']","['betamethasone dipropionate', 'Cal/BD foam', 'fixed-dose combination calcipotriol', 'calcipotriol']","['Mean PASI', 'body and scalp', 'mild; none led to study withdrawal or death', 'treatment-emergent adverse events (TEAEs) and systemic calcium levels in the overall population, and HPA-axis function, change in calcium excretion and the calcium:creatinine ratio', 'exploratory efficacy endpoints [treatment success: change in Psoriasis Area and Severity Index (PASI', 'albumin-corrected serum calcium (overall population) and urinary calcium excretion (HPA-axis cohort', 'urinary calcium:creatinine ratio', 'Safety and efficacy']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0053523', 'cui_str': 'betamethasone dipropionate'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3653162', 'cui_str': 'calcipotriol, combinations'}, {'cui': 'C0065767', 'cui_str': 'calcipotriol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0201925', 'cui_str': 'Calcium measurement (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.1012,Mean PASI decreased by 82.0% vs. baseline at Week 4.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Seyger', 'Affiliation': 'Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Abramovits', 'Affiliation': 'Dermatology Treatment & Research Centre, Dallas, TX, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liljedahl', 'Affiliation': 'Medical Department, LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Hoejen', 'Affiliation': 'Biostatistics, LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Teng', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Stanford, CA, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16233']
3197,31610549,Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial.,"Background
The potential role of new oral anticoagulants in antiphospholipid antibody syndrome (APS) remains uncertain.
Objective
To determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic APS.
Design
3-year, open-label, randomized noninferiority trial. (EU Clinical Trials Register: EUDRA [European Union Drug Regulatory Authorities] code 2010-019764-36).
Setting
6 university hospitals in Spain.
Participants
190 adults (aged 18 to 75 years) with thrombotic APS.
Intervention
Rivaroxaban (20 mg/d or 15 mg/d, according to renal function) versus dose-adjusted VKAs (target international normalized ratio, 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).
Measurements
The primary efficacy outcome was the proportion of patients with new thrombotic events; the primary safety outcome was major bleeding. The prespecified noninferiority margin for risk ratio (RR) was 1.40. Secondary outcomes included time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding.
Results
After 3 years of follow-up, recurrent thrombosis occurred in 11 patients (11.6%) in the rivaroxaban group and 6 (6.3%) in the VKA group (RR in the rivaroxaban group, 1.83 [95% CI, 0.71 to 4.76]). Stroke occurred more commonly in patients receiving rivaroxaban (9 events) than in those receiving VKAs (0 events) (corrected RR, 19.00 [CI, 1.12 to 321.9]). Major bleeding occurred in 6 patients (6.3%) in the rivaroxaban group and 7 (7.4%) in the VKA group (RR, 0.86 [CI, 0.30 to 2.46]). Post hoc analysis suggested an increased risk for recurrent thrombosis in rivaroxaban-treated patients with previous arterial thrombosis, livedo racemosa, or APS-related cardiac valvular disease.
Limitation
Anticoagulation intensity was not measured in the rivaroxaban group.
Conclusion
Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
Primary Funding Source
Bayer Hispania.",2019,"Conclusion
Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","['Setting\n\n\n6 university hospitals in Spain', 'Participants\n\n\n190 adults (aged 18 to 75 years) with thrombotic APS', 'Antiphospholipid Syndrome']","['Rivaroxaban Versus Vitamin K Antagonist', 'vitamin K antagonists (VKAs', 'rivaroxaban', 'Rivaroxaban']","['risk ratio (RR', 'Major bleeding', 'Limitation\n\n\nAnticoagulation intensity', 'proportion of patients with new thrombotic events; the primary safety outcome was major bleeding', 'recurrent thrombosis', 'time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding', 'Stroke']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid Antibody Syndrome'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",190.0,0.206485,"Conclusion
Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Ordi-Ros', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sáez-Comet', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Pérez-Conesa', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Riera-Mestre', 'Affiliation': 'Bellvitge University Hospital-IDIBELL, Barcelona, Spain (A.R.).'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castro-Salomó', 'Affiliation': 'Sant Joan de Reus University Hospital, Reus, Spain (A.C.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cuquet-Pedragosa', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Ortiz-Santamaria', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Mauri-Plana', 'Affiliation': 'Mataró Hospital, Mataró, Spain (M.M.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Solé', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Cortés-Hernández', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}]",Annals of internal medicine,['10.7326/M19-0291']
3198,32068870,Low-Dose Naltrexone for the Treatment of Fibromyalgia: Investigation of Dose-Response Relationships.,"OBJECTIVE
This study explores dose-response relationships when treating fibromyalgia with low-dose naltrexone.
DESIGN
A single-blinded clinical trial was carried out using the ""up-and-down"" method.
SUBJECTS
Subjects included women with a diagnosis of fibromyalgia aged 18-60 years who had been referred to treatment at a public pain clinic at a Danish university hospital.
METHODS
The test doses were in the range 0.75-6 mg, and the dosing interval was 0.75 mg. The method was sequential and allowed predicting the dose effective in 50% (ED50) and 95% (ED95) of the subjects when the dose had shifted direction 10 times, and six pairs of ""up-and-down"" data were available.
RESULTS
A total of 27 subjects were included in the study; two subjects were withdrawn. After inclusion of 25 evaluable subjects, the dose estimates were calculated as 3.88 mg for ED50 and 5.40 mg for ED95. As a secondary outcome, the effects on 10 common fibromyalgia symptoms were evaluated. A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone.
CONCLUSIONS
This study is the first to explore dose-response relationships in the treatment of fibromyalgia with low-dose naltrexone. Future placebo-controlled randomized clinical trials are needed, and according to our findings, 4.5 mg, which has previously been used, seems to be a relevant test dose. We recommend that future studies include additional nonpain fibromyalgia symptoms as outcome measures.",2020,"A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone.
","['A total of 27 subjects were included in the study; two subjects were withdrawn', 'Subjects included women with a diagnosis of fibromyalgia aged 18-60\u2009years who had been referred to treatment at a public pain clinic at a Danish university hospital']","['placebo', 'naltrexone', 'Naltrexone']",['10 common fibromyalgia symptoms'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242936', 'cui_str': 'Pain Centers'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2.0,0.165937,"A high interindividual variation was observed both in the symptom presentation at baseline and in which symptoms were reduced by low-dose naltrexone.
","[{'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Bruun-Plesner', 'Affiliation': 'Pain Research Group, Pain Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Morten Rune', 'Initials': 'MR', 'LastName': 'Blichfeldt-Eckhardt', 'Affiliation': 'Pain Research Group, Pain Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Henrik Bjarke', 'Initials': 'HB', 'LastName': 'Vaegter', 'Affiliation': 'Pain Research Group, Pain Centre, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Joergen T', 'Initials': 'JT', 'LastName': 'Lauridsen', 'Affiliation': 'Department of Business and Economics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Amris', 'Affiliation': 'Department of Rheumatology, The Parker Institute, Copenhagen University Hospital, Bispebjerg-Frederiksberg, Denmark.'}, {'ForeName': 'Palle', 'Initials': 'P', 'LastName': 'Toft', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Odense University Hospital, Odense, Denmark.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa001']
3199,32009288,Impact of dose-escalation schemes and drug discontinuation on weight loss outcomes with liraglutide 3.0 mg: A model-based approach.,"AIMS
To investigate the impact on weight loss of the treatment changes in overweight or obese people that may be needed in case of gastrointestinal (GI) tolerability issues during escalation of the glucagon-like peptide-1 analogue liraglutide.
MATERIALS AND METHODS
The individual longitudinal body weight data from the main trial periods of three phase II/III trials in overweight or obese patients (56-week treatment with once-daily liraglutide 1.2, 1.8, 2.4 or 3.0 mg or placebo, n = 4952) were analysed using a non-linear mixed-effect modelling approach. Individual pharmacokinetic profiles were derived based on published pharmacokinetic models. Baseline body weight, baseline glycated haemoglobin (HbA1c), age, gender, diabetes status (no diabetes, prediabetes or type 2 diabetes), race and trial region were investigated as covariates. As a form of external validation, the model was used to predict the weight regain after treatment cessation at week 56 (data not included in model development).
RESULTS
A pharmacokinetic/pharmacodynamic model provided an adequate description of the weight loss trajectories for all studied doses. Gender and diabetes status were identified as the most influential covariates, and an underlying seasonal weight fluctuation was identified. Slower than that recommended, one-week dose-escalation algorithms led up to 2 weeks slower initial weight loss but similar long-term weight loss trajectories.
CONCLUSIONS
The relationship between liraglutide systemic exposure and weight loss was successfully established in overweight or obese people. The model could predict the time course of weight regain after treatment cessation and suggests that GI tolerability can be mitigated by slower escalation with only minor impact on the weight loss trajectory.",2020,The model could predict the time course of weight regain after treatment cessation and suggests that GI tolerability can be mitigated by slower escalation with only minor impact on the weight loss trajectory.,"['overweight or obese people', 'overweight or obese patients (56-week treatment with once-daily liraglutide 1.2, 1.8, 2.4 or 3.0\u2009mg or placebo, n = 4952']",['liraglutide'],"['weight regain', 'weight loss', 'weight loss trajectories', 'initial weight loss', 'weight loss outcomes', 'Baseline body weight, baseline glycated haemoglobin (HbA1c), age, gender, diabetes status (no diabetes, prediabetes or type 2 diabetes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4704807', 'cui_str': 'Weight Loss Trajectory'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",4952.0,0.0321118,The model could predict the time course of weight regain after treatment cessation and suggests that GI tolerability can be mitigated by slower escalation with only minor impact on the weight loss trajectory.,"[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Papathanasiou', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Strathe', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Agersø', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}, {'ForeName': 'Trine Meldgaard', 'Initials': 'TM', 'LastName': 'Lund', 'Affiliation': 'Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rune Viig', 'Initials': 'RV', 'LastName': 'Overgaard', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13985']
3200,31564388,Proteinuria is independently associated with the incidence of primary cardiovascular events in diabetic patients.,"BACKGROUND
Albuminuria is a risk factor for cardiovascular events in diabetic patients, but it is unknown whether proteinuria is also a risk factor for cardiovascular events in these patients.
METHODS
The Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD) trial was performed between 2002 and 2008 to examine the efficacy of low-dose aspirin therapy for the primary prevention of cardiovascular events in type 2 diabetes patients. After the JPAD trial was completed, we continued to follow up the patients until 2015. Among the 2536 patients participating in the JPAD study, 42 were excluded because proteinuria was not checked at registration. We divided the patients into two groups: proteinuria group (n = 446; proteinuria ± or greater) and non-proteinuria groups (n = 2048; proteinuria -). We compared the incident rate of cardiovascular events between the two groups.
RESULTS
During the observation period [median, 10.3 (10.2-10.5) years], 332 patients had a first cardiovascular event. Among 332 patients, 136 patients had cerebrovascular events and 54 patients had acute myocardial infarction. The incidence rate of cardiovascular events was significantly higher in the proteinuria group compared with the non-proteinuria group (HR 1.75, 95%CI 1.36-2.23, p < 0.0001). The incidence rate of cerebrovascular events was also significantly higher in the proteinuria group than in the non-proteinuria group (HR 1.71, 95%CI 1.14-2.49, p = 0.0064). The Cox proportional hazards model revealed that proteinuria was independently associated with cardiovascular events in diabetic patients without a history of cardiovascular events after adjusting for age, gender, body mass index, hemoglobin A1c level, duration of diabetes, and estimated glomerular filtration rate.
CONCLUSIONS
Proteinuria was independently associated with the incidence of primary cardiovascular events in diabetic patients. Proteinuria detected by the dipstick test, which is simple and inexpensive, is useful as a first step in the risk assessment of diabetic patients.",2020,"The Cox proportional hazards model revealed that proteinuria was independently associated with cardiovascular events in diabetic patients without a history of cardiovascular events after adjusting for age, gender, body mass index, hemoglobin A1c level, duration of diabetes, and estimated glomerular filtration rate.
","['type 2 diabetes patients', 'diabetic patients', '332 patients, 136 patients had cerebrovascular events and 54 patients had acute myocardial infarction', '332 patients had a first cardiovascular event', '2536 patients participating in the JPAD study, 42 were excluded because proteinuria was not checked at registration']","['proteinuria group (n\u2009=\u2009446; proteinuria\u2009±\u2009or greater) and non-proteinuria groups', 'Aspirin', 'low-dose aspirin therapy']","['incidence rate of cerebrovascular events', 'incident rate of cardiovascular events', 'incidence rate of cardiovascular events', 'cardiovascular events']","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}]","[{'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4303556', 'cui_str': 'Aspirin therapy'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",2536.0,0.028352,"The Cox proportional hazards model revealed that proteinuria was independently associated with cardiovascular events in diabetic patients without a history of cardiovascular events after adjusting for age, gender, body mass index, hemoglobin A1c level, duration of diabetes, and estimated glomerular filtration rate.
","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Soejima', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan; Health Care Center, Kumamoto University, Kumamoto, Japan. Electronic address: yuuki@gpo.kumamoto-u.ac.jp.'}, {'ForeName': 'Hisao', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': 'National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Sadanori', 'Initials': 'S', 'LastName': 'Okada', 'Affiliation': 'Center for Postgraduate Training, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Chisa', 'Initials': 'C', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Preventive Medicine, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Nakayama Cardiovascular Clinic, Amakusa, Japan.'}, {'ForeName': 'Izuru', 'Initials': 'I', 'LastName': 'Masuda', 'Affiliation': 'Medical Examination Center, Takeda Hospital, Kyoto, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Diabetes Care Center, Jinnouchi Clinic, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Waki', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Shizuoka City Shizuoka Hospital, Shizuoka, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine, Nara Medical University, Kashihara, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cardiology,['10.1016/j.jjcc.2019.08.021']
3201,31831088,"Breakfast consumption modulates postprandial glycaemic, insulinaemic and NEFA response in pre-diabetic Asian males.","Breakfast consumption is associated with a variety of nutritional and lifestyle-related health outcomes. The objective of the present study was to investigate how the consumption of breakfast affected blood glucose, insulin and NEFA profiles. A lower postprandial blood glucose, insulin and NEFA response is associated with a lower risk of development of metabolic diseases. In a randomised crossover non-blind design, thirteen pre-diabetic Chinese adult males (BMI 26·7 (sd 4·2) kg/m2) attended two sessions where they either consumed a high-glycaemic index breakfast or no breakfast consumption. Changes in glycaemic response over 27 h periods were measured using the Medtronic MiniMed iProTM2 continuous glucose monitoring system. Blood samples were collected using a peripheral venous catheter at fixed intervals for 3 h after the test meal and 3 h after standardised lunch consumption. Postprandial glucose, insulin and NEFA response was calculated as total AUC and incremental AUC using the trapezoidal rule that ignored the area under the baseline. It was found that breakfast consumption significantly decreased postprandial glucose, insulin and NEFA excursion response at lunch time (P = 0·001). Consumption of breakfast attenuated blood glucose profiles by minimising glycaemic excursions and reduced both insulinaemic and NEFA responses in pre-diabetic Asian males during the second meal. This simple dietary intervention may be a novel approach to help improve subsequent lunch glycaemic responses in Asians at high risk of developing diabetes.",2020,"It was found that breakfast consumption significantly decreased postprandial glucose, insulin and NEFA excursion response at lunch time (P = 0·001).","['pre-diabetic Asian males', 'Asians at high risk of developing diabetes', 'thirteen pre-diabetic Chinese adult males (BMI 26·7 (sd 4·2']","['Breakfast consumption', 'high-glycaemic index breakfast or no breakfast consumption']","['subsequent lunch glycaemic responses', 'glycaemic response', 'Postprandial glucose, insulin and NEFA response', 'postprandial glucose, insulin and NEFA excursion response at lunch time', 'blood glucose, insulin and NEFA profiles', 'insulinaemic and NEFA responses', 'postprandial glycaemic, insulinaemic and NEFA response', 'postprandial blood glucose, insulin and NEFA response']","[{'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0585039', 'cui_str': 'Lunchtime'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0262898,"It was found that breakfast consumption significantly decreased postprandial glucose, insulin and NEFA excursion response at lunch time (P = 0·001).","[{'ForeName': 'Elaine Wan Yi', 'Initials': 'EWY', 'LastName': 'Peh', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, Singapore117599.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Koecher', 'Affiliation': 'General Mills James Ford Bell Research Center, 9000 Plymouth Ave N, Minneapolis, MN55427, USA.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Menon', 'Affiliation': 'General Mills James Ford Bell Research Center, 9000 Plymouth Ave N, Minneapolis, MN55427, USA.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Clinical Nutrition Research Centre (CNRC), Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR) and National University Health System, Singapore117599.'}]",The British journal of nutrition,['10.1017/S0007114519003180']
3202,31694978,Weight Loss and Illness Severity in Adolescents With Atypical Anorexia Nervosa.,"BACKGROUND
Lower weight has historically been equated with more severe illness in anorexia nervosa (AN). Reliance on admission weight to guide clinical concern is challenged by the rise in patients with atypical anorexia nervosa (AAN) requiring hospitalization at normal weight.
METHODS
We examined weight history and illness severity in 12- to 24-year-olds with AN ( n = 66) and AAN ( n = 50) in a randomized clinical trial, the Study of Refeeding to Optimize Inpatient Gains (www.clinicaltrials.gov; NCT02488109). Amount of weight loss was the difference between the highest historical percentage median BMI and admission; rate was the amount divided by duration (months). Unpaired t tests compared AAN and AN; multiple variable regressions examined associations between weight history variables and markers of illness severity at admission. Stepwise regression examined the explanatory value of weight and menstrual history on selected markers.
RESULTS
Participants were 16.5 ± 2.6 years old, and 91% were of female sex. Groups did not differ by weight history or admission heart rate (HR). Eating Disorder Examination Questionnaire global scores were higher in AAN (mean 3.80 [SD 1.66] vs mean 3.00 [SD 1.66]; P = .02). Independent of admission weight, lower HR (β = -0.492 [confidence interval (CI) -0.883 to -0.100]; P = .01) was associated with faster loss; lower serum phosphorus was associated with a greater amount (β = -0.005 [CI -0.010 to 0.000]; P = .04) and longer duration (β = -0.011 [CI -0.017 to 0.005]; P = .001). Weight and menstrual history explained 28% of the variance in HR and 36% of the variance in serum phosphorus.
CONCLUSIONS
Weight history was independently associated with markers of malnutrition in inpatients with restrictive eating disorders across a range of body weights and should be considered when assessing illness severity on hospital admission.",2019,Eating Disorder Examination Questionnaire global scores were higher in AAN (mean 3.80 [SD 1.66] vs mean 3.00 [SD 1.66]; P = .02).,"['Participants were 16.5 ± 2.6 years old, and 91% were of female sex', 'patients with atypical anorexia nervosa (AAN) requiring hospitalization at normal weight', 'Adolescents With Atypical Anorexia Nervosa', '12- to 24-year-olds with AN ( n = 66) and AAN ( n = 50', 'inpatients with restrictive eating disorders']",[],"['weight history or admission heart rate (HR', 'Eating Disorder Examination Questionnaire global scores', 'Weight and menstrual history', 'weight history and illness severity', 'weight loss', 'Weight Loss and Illness Severity']","[{'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338959', 'cui_str': 'Atypical anorexia nervosa (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2959762', 'cui_str': 'Eating disorder examination questionnaire global score (observable entity)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",,0.0478223,Eating Disorder Examination Questionnaire global scores were higher in AAN (mean 3.80 [SD 1.66] vs mean 3.00 [SD 1.66]; P = .02).,"[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Garber', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics, andrea.garber@ucsf.edu.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'Preventive and Restorative Dental Sciences.'}, {'ForeName': 'Erin C', 'Initials': 'EC', 'LastName': 'Accurso', 'Affiliation': 'Psychiatry, and.'}, {'ForeName': 'Sally H', 'Initials': 'SH', 'LastName': 'Adams', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics.'}, {'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Buckelew', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics.'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Kapphahn', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kreiter', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Le Grange', 'Affiliation': 'Psychiatry, and.'}, {'ForeName': 'Vanessa I', 'Initials': 'VI', 'LastName': 'Machen', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Departments of Pediatrics.'}, {'ForeName': 'Anna-Barbara', 'Initials': 'AB', 'LastName': 'Moscicki', 'Affiliation': 'Division of Adolescent and Young Adult Medicine, Department of Pediatrics, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Saffran', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Allyson F', 'Initials': 'AF', 'LastName': 'Sy', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Clinical Pharmacy, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Neville H', 'Initials': 'NH', 'LastName': 'Golden', 'Affiliation': 'Division of Adolescent Medicine, Department of Pediatrics, Stanford University, Stanford, California.'}]",Pediatrics,['10.1542/peds.2019-2339']
3203,31859087,The effect of a hydrolyzed collagen-based supplement on wound healing in patients with burn: A randomized double-blind pilot clinical trial.,"INTRODUCTION
Burn is among the most severe forms of critical illness, associated with extensive and prolonged physical, metabolic and mental disorders. The aim of this study was to assess the effect of an oral, low-cost, and accessible collagen-based supplement on wound healing in patients with burn.
METHODS
In this randomized double-blind controlled pilot clinical trial, 31 men, 18-60years, with 20-30% total body surface area burn were studied. Patients were randomly assigned to receive either a collagen-based supplement (1000kcal) or an isocaloric placebo, for 4 weeks. Serum pre-albumin, rate of wound healing, length of hospital stay, and anthropometries were assessed at baseline, and the end of week 2 and 4.
RESULTS
Serum pre-albumin was significantly higher at week 2 (29.7±13.6 vs. 17.8±7.5mg/dL, P=0.006) and week 4 (35.1±7.6 vs. 28.3±8.2mg/dL, P=0.023) in collagen than control group. Changes in pre-albumin concentration were also significantly higher in collagen group at week 2 (13.9±9.8 vs. -1.9±10.3mg/dL, P<0.001) and week 4 (19.2±7.5 vs. 8.5±10.1mg/dL, P=0.002). The Hazard ratio of wound healing was 3.7 times in collagen compared to control group (95% CI: 1.434-9.519, P=0.007). Hospital stay was clinically, but not statistically, lower in collagen than control group (9.4±4.6 vs. 13.5±7 days, P=0.063). There were no significant differences in weight, body mass index, dietary energy and protein intakes between the two groups.
CONCLUSION
The findings showed that a hydrolyzed collagen-based supplement could significantly improve wound healing and circulating pre-albumin, and clinically reduce hospital stay in patients with 20-30% burn.",2020,"Hospital stay was clinically, but not statistically, lower in collagen than control group (9.4±4.6 vs. 13.5±7 days, P=0.063).","['31 men, 18-60years, with 20-30% total body surface area burn were studied', 'patients with burn']","['hydrolyzed collagen-based supplement', 'collagen-based supplement (1000kcal) or an isocaloric placebo', 'oral, low-cost, and accessible collagen-based supplement']","['hospital stay', 'weight, body mass index, dietary energy and protein intakes', 'Hazard ratio of wound healing', 'Changes in pre-albumin concentration', 'Serum pre-albumin', 'Hospital stay', 'wound healing and circulating pre-albumin', 'Serum pre-albumin, rate of wound healing, length of hospital stay, and anthropometries', 'wound healing']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}]",31.0,0.345113,"Hospital stay was clinically, but not statistically, lower in collagen than control group (9.4±4.6 vs. 13.5±7 days, P=0.063).","[{'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Bagheri Miyab', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Alipoor', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Vaghardoost', 'Affiliation': 'Burn Research Center, Department of Plastic and Reconstructive Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Saberi Isfeedvajani', 'Affiliation': 'Burn Research Center, Department of Plastic and Reconstructive Surgery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yaseri', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kurosh', 'Initials': 'K', 'LastName': 'Djafarian', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Hosseinzadeh-Attar', 'Affiliation': 'Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran; Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia. Electronic address: mhosseinzadeh@tums.ac.ir.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.02.015']
3204,32057103,Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial.,"BACKGROUND
Safe laparoscopic cholecystectomy may necessitate biliary imaging, and non-invasive fluorescence cholangiography may have advantages over contrast X-ray cholangiography. This trial compared fluorescence and X-ray cholangiography for visualization of the critical junction between the cystic, common hepatic and common bile ducts.
METHODS
This non-inferiority blinded RCT included patients who had either intraoperative fluorescence cholangiography using 0·05 mg/kg indocyanine green or X-ray cholangiography during elective laparoscopic cholecystectomy.
RESULTS
Between March 2015 and August 2018, a total of 120 patients were randomized (60 in each group). There were no drop-outs and 30-day follow-up data were available for all patients. In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230). Fluorescence cholangiography was faster by a few minutes: median 2·0 (range 0·5-5·0) versus 4·8 (1·3-17·6) min (P < 0·001).
CONCLUSION
Fluorescence cholangiography was confirmed to be non-inferior to X-ray cholangiography in visualizing the critical junction during laparoscopic cholecystectomy. Registration number: NCT02344654 ( http://www.clinicaltrials.gov).",2020,"In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230).","['median 2·0', 'patients who had either intraoperative fluorescence cholangiography using 0·05', 'Between March 2015 and August 2018, a total of 120 patients', 'elective laparoscopic cholecystectomy']","['indocyanine green or X-ray cholangiography', 'Fluorescence cholangiography', 'Fluorescence or X-ray cholangiography', 'fluorescence and X-ray cholangiography']",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0008307', 'cui_str': 'Cholangiography'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0008307', 'cui_str': 'Cholangiography'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}]",[],120.0,0.241528,"In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230).","[{'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'Gastrounit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital, University of Copenhagen, Køge, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Westen', 'Affiliation': 'Gastrounit, Surgical Section, Køge, Denmark.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Larsen', 'Affiliation': 'Gastrounit, Surgical Section, Køge, Denmark.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Jensen', 'Affiliation': 'Radiology Section, Køge, Denmark.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Kristensen', 'Affiliation': 'Ambulatory Surgery Department, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bisgaard', 'Affiliation': 'Surgical Department, Zealand University Hospital, Køge, Denmark.'}]",The British journal of surgery,['10.1002/bjs.11510']
3205,31627998,Pilot study of bisoprolol 8mg transdermal patch at bedtime before coronary computed tomography angiography.,"BACKGROUND
Coronary computed tomography angiography (CCTA) is recommended for first-line evaluation of stable coronary artery disease, and there is a standard protocol to control heart rate (HR) in guidelines. However, time is required to decrease HR to the recommended ≤60 beats per minute (bpm). We investigated whether the bisoprolol 8mg transdermal patch at bedtime on the day before CCTA can achieve a target HR and simplify the CCTA process.
METHODS
We randomly assigned 63 patients with an HR of ≥70 bpm and systolic blood pressure ≥120mmHg to a standard protocol group (n=33) or a group (n=30) that applied a bisoprolol 8mg transdermal patch (Bis) at bedtime on the day before CCTA evaluation. The primary endpoint was a change in HR between enrollment in the study and the time of CCTA evaluation. The secondary endpoints were elapsed time from arrival at the CCTA suite to starting CCTA image acquisition, and the rates of oral metoprolol and intravenous landiolol administration (UMIN00035246).
RESULTS
Baseline characteristics did not significantly differ between two groups. HR was significantly lower upon arrival at the CCTA suite in Bis, than standard protocol group (67.5±7.8 bpm vs. 75.0±10.6 bpm; p=0.00002), and the amount of elapsed time from arrival to the start of CCTA evaluation was also significantly decreased in Bis group (76.9±34.9min vs. 94.8±29.2min; p=0.0356). Rates of oral metoprolol and intravenous landiolol administration did not significantly differ between two groups (63.3% vs. 83.3%, p=0.143 and 36.7% vs. 60.0%, p=0.12, respectively).
CONCLUSIONS
The bisoprolol 8mg transdermal patch lowered HR and decreased the amount of time needed for CCTA, thus streamlining the evaluation process.",2020,"The bisoprolol 8mg transdermal patch lowered HR and decreased the amount of time needed for CCTA, thus streamlining the evaluation process.",['63 patients with an HR of ≥70 bpm and systolic blood pressure ≥120mmHg to a standard protocol group (n=33) or a group (n=30) that applied a'],"['bisoprolol 8mg transdermal patch (Bis', 'bisoprolol 8mg transdermal patch', 'Coronary computed tomography angiography (CCTA', 'metoprolol and intravenous landiolol']","['HR', 'change in HR', 'elapsed time from arrival at the CCTA suite to starting CCTA image acquisition, and the rates of oral metoprolol and intravenous landiolol administration (UMIN00035246', 'time needed for CCTA', 'time of CCTA evaluation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0991556', 'cui_str': 'Transdermal System'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0905464', 'cui_str': 'landiolol'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",63.0,0.0777198,"The bisoprolol 8mg transdermal patch lowered HR and decreased the amount of time needed for CCTA, thus streamlining the evaluation process.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Heart Center, Tokyo, Japan. Electronic address: circulation_777@yahoo.co.jp.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Shimura', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Heart Center, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Enjoji', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Heart Center, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Nishinaga', 'Affiliation': 'Department of Cardiovascular Medicine, Saitama Memorial Hospital, Saitama City, Saitama, Japan.'}, {'ForeName': 'Katuo', 'Initials': 'K', 'LastName': 'Kanmatuse', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Heart Center, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Heart Center, Tokyo, Japan.'}]",Journal of cardiology,['10.1016/j.jjcc.2019.09.013']
3206,31676174,Comparison of Gap Balancing vs Measured Resection Technique in Patients Undergoing Simultaneous Bilateral Total Knee Arthroplasty: One Technique per Knee.,"BACKGROUND
Total knee arthroplasty requires careful surgical technique to attain the goal of a well-aligned and symmetrically balanced knee. Soft tissue balance and correct femoral component rotation are paramount in achieving these goals. The two competing techniques to select femoral component rotation and soft tissue balance are the gap balance technique and the measured resection technique.
METHODS
We performed a randomized, prospective study to compare the two techniques in patients undergoing simultaneous bilateral total knee arthroplasty, whereby one technique was performed in each knee. Fifty (50) subjects were enrolled into the study. The inclusion criteria were osteoarthritic varus knee deformities with similar deformities in both knees. Subjects were followed up for a minimum of two years.
RESULTS
The knees balanced via the gap balance technique had significantly more posterior medial bone removed from the femur than those knees balanced via the measured resection technique (P < .001). Knees in the gap balance group tended to require more medial knee releases in extension and tended to have smaller sized femoral components as a result of cutting more bone from the femur in flexion. The modular tibial polyethylene bearing tended to be thicker in the gap balance group. Despite these differences, average knee flexion and functional revised Oxford Knee Scores at 2-year follow-up were not statistically different.
CONCLUSION
At 2-year follow-up, there were no differences between the function and scores using the two techniques. Long-term follow-up will be necessary to evaluate any differences in long-term durability.",2020,"Despite these differences, average knee flexion and functional revised Oxford Knee Scores at 2-year follow-up were not statistically different.
","['Patients', 'Fifty (50) subjects were enrolled into the study', 'Undergoing Simultaneous Bilateral Total Knee Arthroplasty', 'patients undergoing simultaneous bilateral total knee arthroplasty']",['Gap Balancing vs Measured Resection Technique'],"['medial knee releases', 'posterior medial bone', 'average knee flexion and functional revised Oxford Knee Scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}]",,0.0284105,"Despite these differences, average knee flexion and functional revised Oxford Knee Scores at 2-year follow-up were not statistically different.
","[{'ForeName': 'Sachin R', 'Initials': 'SR', 'LastName': 'Tapasvi', 'Affiliation': 'Department of Arthroplasty and Arthroscopy, The Orthopaedic Specialty Clinic, Pune, Maharashtra, India.'}, {'ForeName': 'Anshu', 'Initials': 'A', 'LastName': 'Shekhar', 'Affiliation': 'Department of Arthroplasty and Arthroscopy, The Orthopaedic Specialty Clinic, Pune, Maharashtra, India.'}, {'ForeName': 'Shantanu S', 'Initials': 'SS', 'LastName': 'Patil', 'Affiliation': 'SRM Medical College and Hospitals, SRM University, Kattankulathur, Kancheepuram, Tamilnadu, India.'}, {'ForeName': 'Matthew V', 'Initials': 'MV', 'LastName': 'Dipane', 'Affiliation': 'Department of Orthopaedic Surgery, David Geffen School of Medicine at UCLA, Santa Monica, CA.'}, {'ForeName': 'Madhav', 'Initials': 'M', 'LastName': 'Chowdhry', 'Affiliation': 'Department of Orthopaedic Surgery, David Geffen School of Medicine at UCLA, Santa Monica, CA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'McPherson', 'Affiliation': 'Department of Orthopaedic Surgery, David Geffen School of Medicine at UCLA, Santa Monica, CA.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.10.002']
3207,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE
Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS
Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS
V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION
Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3208,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3209,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3210,31292955,"In overweight and obese women, fetal ultrasound biometry accurately predicts newborn measures.","INTRODUCTION
The aim of this study was to evaluate the association between fetal ultrasound and newborn biometry and adiposity measures in the setting of maternal obesity.
MATERIAL AND METHODS
The study population involved 845 overweight or obese pregnant women, who participated in the Standard Care Group of the LIMIT randomised trial (ACTRN12607000161426, 9/03/2007). At 36 weeks gestation, fetal biometry, estimated fetal weight (EFW) and adiposity measures including mid-thigh fat mass (MTFM), subscapular fat mass (SSFM), and abdominal fat mass (AFM) were undertaken using ultrasound. Neonatal anthropometric measurements obtained after birth included birthweight, head circumference (HC), abdominal circumference (AC) and skinfold thickness measurements (SFTM) of the subscapular region and abdomen.
RESULTS
At 36 weeks gestation, every 1 g increase in EFW was associated with a 0.94 g increase in birthweight (95% CI 0.88-0.99; P < 0.001). For every 1 mm increase in the fetal ultrasound measure, there was a 0.69 mm increase in birth HC (95% CI 0.63-0.75, P < 0.001) and 0.69 mm increase in birth AC (95% CI 0.60-0.79, P < 0.001). Subscapular fat mass in the fetus and the newborn (0.29 mm, 95% CI 0.20-0.39, P < 0.001) were moderately associated, but AFM measurements were not (0.06 mm, -0.03 to 0.15, P = 0.203). There is no evidence that these relationships differed by maternal body mass index.
CONCLUSION
In women who are overweight or obese, fetal ultrasound accurately predicts neonatal HC and AC along with birthweight.",2020,"Subscapular fat mass in the fetus and the newborn (0.29 mm, 95% CI 0.20-0.39, P ","['845 overweight or obese pregnant women, who participated in the Standard Care Group of the LIMIT randomised trial (ACTRN12607000161426, 9/03/2007']",[],"['Subscapular fat mass', 'birthweight, head circumference (HC), abdominal circumference (AC) and skinfold thickness measurements (SFTM) of the subscapular region and abdomen', 'fetal ultrasound measure', 'birth AC', 'birthweight', 'EFW', 'fetal biometry, estimated fetal weight (EFW) and adiposity measures including mid-thigh fat mass (MTFM), subscapular fat mass (SSFM), and abdominal fat mass (AFM', 'AFM measurements', 'birth HC', 'fetal ultrasound and newborn biometry and adiposity measures']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",[],"[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C1300813', 'cui_str': 'Abdominal circumference (observable entity)'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0005544', 'cui_str': 'Biometry'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1563742', 'cui_str': 'Abdominal Fat'}, {'cui': 'C1529904', 'cui_str': '(11C)AFM'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]",845.0,0.18035,"Subscapular fat mass in the fetus and the newborn (0.29 mm, 95% CI 0.20-0.39, P ","[{'ForeName': 'Cecelia M', 'Initials': 'CM', 'LastName': ""O'Brien"", 'Affiliation': 'School of Paediatrics and Reproductive Health, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'School of Paediatrics and Reproductive Health, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deussen', 'Affiliation': 'School of Paediatrics and Reproductive Health, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': 'School of Paediatrics and Reproductive Health, and Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}]",The Australian & New Zealand journal of obstetrics & gynaecology,['10.1111/ajo.13025']
3211,31984646,"Liraglutide as add-on to sodium-glucose co-transporter-2 inhibitors in patients with inadequately controlled type 2 diabetes: LIRA-ADD2SGLT2i, a 26-week, randomized, double-blind, placebo-controlled trial.","AIM
To compare the effect of liraglutide or placebo added on to sodium-glucose co-transporter-2 inhibitor (SGLT2i) ± metformin on glycaemic control in patients with type 2 diabetes.
MATERIALS AND METHODS
Patients with type 2 diabetes on a stable SGLT2i dose ± metformin (with HbA1c 7.0%-9.5% and body mass index [BMI] ≥ 20 kg/m 2 ) were randomized 2:1 to add-on liraglutide 1.8 mg/day or placebo in this parallel, double-blind, multinational trial. Primary and confirmatory secondary endpoints were changes in HbA1c and body weight from baseline to week 26, respectively. The proportions of patients achieving HbA1c (<7.0%) targets and safety events after week 26 were also assessed.
RESULTS
Of 303 patients randomized (one in error), 280 completed treatment. Mean changes in HbA1c from baseline to week 26 with liraglutide (n = 202) and placebo (n = 100) were - 0.98% and - 0.30%, respectively (estimated treatment difference [ETD]: -0.68% [95% CI: -0.89, -0.48]; P < 0.001). Mean body weight changes from baseline were - 2.81 versus -1.99 kg, respectively (ETD: -0.82 kg [95% CI: -1.73, 0.09]; P = 0.077); 51.8% of liraglutide-treated patients achieved HbA1c < 7.0% versus 23.2% receiving placebo (odds ratio: 5.1 [95% CI: 2.67, 9.87]; P < 0.001). More patients treated with liraglutide reported ≥1 treatment-emergent adverse events (66.3%) versus placebo (47.0%).
CONCLUSIONS
Liraglutide significantly improved glycaemic control compared with placebo in patients with type 2 diabetes, insufficiently controlled with SGLT2is with/without metformin, with no unexpected safety findings.",2020,"(ETD: -0.82 kg [95% CI: -1.73, 0.09];","['303 patients randomized (one in error), 280 completed treatment', 'patients with inadequately controlled type 2 diabetes', 'Patients with type 2 diabetes on a stable SGLT2i dose ± metformin (with HbA 1c 7.0-9.5% and body mass index', 'patients with type 2 diabetes']","['liraglutide or placebo', 'liraglutide 1.8 mg/day or placebo', 'LIRA-ADD2SGLT2i', 'Liraglutide', 'liraglutide', 'placebo', 'Glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2is', 'SGLT2i±metformin']","['Mean body weight changes', 'safety events', 'changes in HbA 1c and body weight', 'Mean changes in HbA 1c', 'glycated haemoglobin (HbA 1c ) levels', '≥1 treatment-emergent adverse events', 'glycaemic control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",303.0,0.5815,"(ETD: -0.82 kg [95% CI: -1.73, 0.09];","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Ochsner Diabetes Clinical Research Unit, Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, Louisiana, United States.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Belousova', 'Affiliation': 'Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Udi', 'Initials': 'U', 'LastName': 'Fainberg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Garcia-Hernandez', 'Affiliation': 'Endocrinology Service, University Hospital, Monterrey, Mexico.'}, {'ForeName': 'Sunil M', 'Initials': 'SM', 'LastName': 'Jain', 'Affiliation': 'Endocrinology, TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Margit S', 'Initials': 'MS', 'LastName': 'Kaltoft', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Nafach', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, United Arab Emirates.'}, {'ForeName': 'Mads Sundby', 'Initials': 'MS', 'LastName': 'Palle', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Rosangela', 'Initials': 'R', 'LastName': 'Rea', 'Affiliation': 'Endocrinology and Metabolism Service (SEMPR), Universidade Federal do Paraná, Curitiba, Brazil.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13978']
3212,32033527,"Vitamin D supplementation improves SIRT1, Irisin, and glucose indices in overweight or obese type 2 diabetic patients: a double-blind randomized placebo-controlled clinical trial.","BACKGROUND
Vitamin D (VD) may increase sirtuin 1 (SIRT1) and subsequently PPAR-γ coactivator 1α (PGC-1α) and irisin levels and these improvements may reduce insulin resistance (IR). The aim was to assess the effects of vitamin D supplementation on SIRT1, irisin, and IR in overweight/obese type 2 diabetes (T2D) patients.
METHODS
Ninety T2D males and females were recruited as a clinical trial study (mean of age and body mass index (BMI) of intervention and placebo groups were 50.05 ± 10.17 and 50.36 ± 10.2 yrs. and 31.37 ± 3.4 and 30.43 ± 3.2 kg/m 2 , respectively). The inclusion criteria were T2D, VD deficient, BMI > 25 kg/m 2 , and serum HbA1c < 8.5%. The exclusion criteria were using vitamin and mineral supplements, having any acute disease, recent modifying dose or type of drugs. The supplementation was 50,000 IU/week VD or placebo for 8 weeks. The demographic characteristics, anthropometrics, dietary intakes and physical activity status, sun exposure status, fasting blood sugar (FBS) and insulin, glycosylated hemoglobin (HbA1c), irisin, SIRT1, 25-hydroxy D3 (25(OH)VD), homeostasis model assessment of insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI) were determined. The significant P-value was ≤0.05.
RESULTS
The increase of serum VD, SIRT1, and irisin in the intervention group was significant (p < 0.001). HbA1c was decreased significantly by 1%. The changes in the other glucose indices (FBS, insulin, and IR) were non-significant.
CONCLUSIONS
VD supplementation may improve T2D by decreasing HbA1c and increasing SIRT1 and irisin in VD deficient T2D patients. Further trials are suggested.
TRIAL REGISTRATION
Iranian Registry of Clinical Trials, IRCT201604202365N11. Registered 21/08/2016, http://en.irct.ir/trial/2019.",2020,"The changes in the other glucose indices (FBS, insulin, and IR) were non-significant.
CONCLUSIONS
VD supplementation may improve T2D by decreasing HbA1c and increasing SIRT1 and irisin in VD deficient T2D patients.","['T2D males and females were recruited as a clinical trial study (mean of age and body mass index (BMI) of intervention and placebo groups were 50.05\u2009±\u200910.17 and 50.36\u2009±\u200910.2\u2009yrs. and 31.37\u2009±\u20093.4 and 30.43\u2009±\u20093.2\u2009kg/m 2 , respectively', 'Ninety', 'VD deficient T2D patients', 'overweight or obese type 2 diabetic patients', 'overweight/obese type 2 diabetes (T2D) patients']","['Vitamin D supplementation', 'placebo', 'vitamin D supplementation', 'Vitamin D (VD']","['SIRT1, Irisin, and glucose indices', 'glucose indices (FBS, insulin, and IR', 'demographic characteristics, anthropometrics, dietary intakes and physical activity status, sun exposure status, fasting blood sugar (FBS) and insulin, glycosylated hemoglobin (HbA1c), irisin, SIRT1, 25-hydroxy D3 (25(OH)VD), homeostasis model assessment of insulin resistance (HOMA-IR), and quantitative insulin sensitivity check index (QUICKI', 'HbA1c', 'SIRT1, irisin, and IR', 'insulin resistance (IR', 'serum VD, SIRT1, and irisin']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517692', 'cui_str': '3.4 (qualifier value)'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}]","[{'cui': 'C2720167', 'cui_str': 'Sirt1'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.253179,"The changes in the other glucose indices (FBS, insulin, and IR) were non-significant.
CONCLUSIONS
VD supplementation may improve T2D by decreasing HbA1c and increasing SIRT1 and irisin in VD deficient T2D patients.","[{'ForeName': 'Peivasteh', 'Initials': 'P', 'LastName': 'Safarpour', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Daneshi-Maskooni', 'Affiliation': 'Department of Nutrition, School of Medicine, Jiroft University of Medical Sciences, Jiroft, Kerman, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. rezavafa@yahoo.com.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Nourbakhsh', 'Affiliation': 'Department of Biochemistry, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Janani', 'Affiliation': 'Department of Biostatistics, School of Public Health, Preventive Medicine and Public Health Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Maddah', 'Affiliation': 'Department of Medicine, School of Medicine, Guilan University of Medical Sciences, Guilan, Iran.'}, {'ForeName': 'Fatemeh-Sadat', 'Initials': 'FS', 'LastName': 'Amiri', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Medicine, School of Medicine, Guilan University of Medical Sciences, Guilan, Iran.'}, {'ForeName': 'Homa', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': 'Department of Epidemiology, University of Massachusetts Lowell, Lowell, MA, USA.'}]",BMC family practice,['10.1186/s12875-020-1096-3']
3213,31647277,Parent-teen communication predicts treatment benefit for depressed and suicidal adolescents.,"OBJECTIVE
Although there are currently several efficacious treatments for depressed and suicidal adolescents, less is known about predictors and moderators of adolescents' treatment response. A growing literature has identified family functioning as a prognostic indicator of adolescents' likelihood of benefiting from treatment. The current study tested both observational and perceived measures of family functioning as indicators of adolescents' response to 2 treatment conditions.
METHOD
The sample consisted of 129 depressed and suicidal adolescents ( M age = 14.96, 82.9% female, 56% Black/African American) who were randomized to attachment-based family therapy or family-enhanced nondirective supportive therapy (Diamond et al., 2019). Baseline assessments of family functioning included ratings of parent-adolescent communication coded with the Goal-Corrected Partnership in Adolescence Coding System (Lyons-Ruth, Hennighausen, & Holmes, 2005) and adolescent and parent reports of Family Conflict and Cohesion from the Self-Report of Family Functioning (Bloom, 1985).
RESULTS
Adolescents who engaged in more uncooperative communication with their parents during a 10-min conflict discussion showed greater reductions in depressive symptoms in both treatments. Adolescents from traditionally underserved (non-White or lower income) families showed greater reductions in suicidal ideation in both treatments.
CONCLUSIONS
Attachment-based family therapy and family-enhanced nondirective supportive therapy were most effective for adolescents from traditionally underserved families and adolescents who engaged in less cooperative communication with their caregivers. Observational ratings of parent-adolescent communication were better prognostic indicators of treatment response than were self-reported indicators of global family functioning. Implications for generalizing these results to other treatments for depressed and suicidal adolescents are discussed. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,Observational ratings of parent-adolescent communication were better prognostic indicators of treatment response than were self-reported indicators of global family functioning.,"['129 depressed and suicidal adolescents ( M age = 14.96, 82.9% female, 56% Black/African American', 'depressed and suicidal adolescents', 'Adolescents from traditionally underserved (non-White or lower income) families']","['Attachment-based family therapy and family-enhanced nondirective supportive therapy', 'attachment-based family therapy or family-enhanced nondirective supportive therapy']","['depressive symptoms', 'suicidal ideation']","[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}]",129.0,0.0434605,Observational ratings of parent-adolescent communication were better prognostic indicators of treatment response than were self-reported indicators of global family functioning.,"[{'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Zisk', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'Caroline H', 'Initials': 'CH', 'LastName': 'Abbott', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Bounoua', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'Guy S', 'Initials': 'GS', 'LastName': 'Diamond', 'Affiliation': 'Drexel University.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kobak', 'Affiliation': 'University of Delaware.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000457']
3214,32052748,Music and pain during endorectal ultrasonography examination: A prospective questionnaire study and literature review.,"INTRODUCTION
Music interventions have been recognized as a method to reduce pain during medical procedures, but within medical imaging the subject has received little attention. Endorectal ultrasonography examination is in some patients associated with anxiety and pain, and since in Denmark pain relief is usually not administered by the Department of Radiology, it is important to find effective alternative methods to help patients manage their pain during imaging procedures. The primary aim of this study was to evaluate the effect of music on self-reported pain during endorectal examination of rectal cancer patients.
METHODS
A prospective questionnaire study of patients undergoing endorectal ultrasonography was conducted. Patients were randomized into two groups: a music group (n = 66), and non-music group (n = 60). Standard endorectal ultrasonography was performed in all patients. Pain was self-assessed using a Visual Analogue Scale ranging from 0 to 10, with 0 representing ""no pain"" and 10 maximum pain.
RESULTS
A total of 126 patients were included in the study, 81 (64.3%) men and 45 (35.7%) women. The demographics were similar in the two groups. The mean pain score during endorectal ultrasonography in the music and non-music group was 1.95 and 2.30, (p = 0.404).
CONCLUSION
In this randomized study music did not significantly affect the pain level experienced by the patients. Endorectal ultrasound was not entirely painless but less painful than colonoscopy (Visual Analogue Scale 2.1 and 3.8, respectively).
IMPLICATIONS FOR PRACTICE
Health care professionals may consider using music during painful procedures.",2020,"Endorectal ultrasound was not entirely painless but less painful than colonoscopy (Visual Analogue Scale 2.1 and 3.8, respectively).
","['rectal cancer patients', 'patients undergoing', 'A total of 126 patients were included in the study, 81 (64.3%) men and 45 (35.7%) women']","['endorectal ultrasonography examination', 'music group (n\xa0=\xa066), and non-music group', 'Standard endorectal ultrasonography', 'endorectal ultrasonography', 'Endorectal ultrasonography examination']","['pain level', 'Music and pain', 'mean pain score', 'Pain was self-assessed using a Visual Analogue Scale']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C2315751', 'cui_str': 'Endorectal ultrasonography'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",126.0,0.0850938,"Endorectal ultrasound was not entirely painless but less painful than colonoscopy (Visual Analogue Scale 2.1 and 3.8, respectively).
","[{'ForeName': 'M R V', 'Initials': 'MRV', 'LastName': 'Pedersen', 'Affiliation': 'Department of Radiology, University Hospital, Vejle, Beriderbakken 4, DK-7100 Vejle, Denmark; Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark; Danish Colorectal Cancer Center South, Institute of Regional Health Research, University of Southern Denmark, Odense DK-5000, Denmark. Electronic address: malene.roland.vils.pedersen@rsyd.dk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dam', 'Affiliation': 'Department of Radiology, University Hospital, Vejle, Beriderbakken 4, DK-7100 Vejle, Denmark.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Rafaelsen', 'Affiliation': 'Department of Radiology, University Hospital, Vejle, Beriderbakken 4, DK-7100 Vejle, Denmark; Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark; Danish Colorectal Cancer Center South, Institute of Regional Health Research, University of Southern Denmark, Odense DK-5000, Denmark.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2020.01.004']
3215,32052755,Optimisation of the lateral lumbar spine projection using an air-gap technique.,"INTRODUCTION
Lumbar spine radiography is considered as having a high radiation dose compared to other planar radiography examinations. The aim of this study was to investigate the feasibility of replacing an antiscatter grid with an air gap technique to achieve dose reduction for lateral lumbar spine radiography while maintaining image quality on a direct digital radiography (DDR) system.
METHODS
In phase 1, an experimental study using an anthropomorphic phantom identified the optimal airgap technique. In phase 2, lateral projections of the lumbar spine were performed on 50 patients randomly assigned equally into a control group (using the antiscatter grid) and an experimental group (using the airgap technique). The dose area product (DAP) was recorded, keeping other variables constant. Image quality evaluation was performed by 5 radiologists performing Absolute Visual Grading Analysis (VGA) using an image quality score tool, with resultant scores analysed using Visual Grading Characteristics (VGC).
RESULTS
A 10 cm airgap in conjunction with a source to image distance (SID) of 121 cm was found as the optimal airgap technique. The clinical application of this technique resulted in a statistically significant (p < 0.05) reduction in DAP of 72%. Image quality scores were higher for the antiscatter grid but variation between the two techniques was not significant (p > 0.05).
CONCLUSION
Replacing the antiscatter grid with an airgap technique in lateral lumbar spine digital radiography, provides a significant dose reduction whilst still maintaining diagnostic image quality.
IMPLICATIONS FOR PRACTICE
The airgap technique is a simple and easy technique to implement and radiographers should find no difficulties in applying it, as It involves no additional cost and no additional equipment.",2020,The clinical application of this technique resulted in a statistically significant (p < 0.05) reduction in DAP of 72%.,[],[],"['Image quality scores', 'Visual Grading Characteristics (VGC', 'dose area product (DAP']",[],[],"[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}]",50.0,0.0174193,The clinical application of this technique resulted in a statistically significant (p < 0.05) reduction in DAP of 72%.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bellizzi', 'Affiliation': 'Department of Radiography, Faculty of Health Sciences, University of Malta, Msida, Malta. Electronic address: andrea.bellizzi.15@um.edu.mt.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Zarb', 'Affiliation': 'Department of Radiography, Faculty of Health Sciences, University of Malta, Msida, Malta. Electronic address: francis.zarb@um.edu.mt.'}]","Radiography (London, England : 1995)",['10.1016/j.radi.2019.12.008']
3216,32065514,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Liver-Targeting Acetyl-CoA Carboxylase Inhibitor (PF-05221304): A Three-Part Randomized Phase 1 Study.","PF-05221304 is a liver-targeted inhibitor of acetyl-CoA carboxylase, an enzyme that catalyzes the first committed step in de novo lipogenesis (DNL). This first-in-human study investigated safety/tolerability and pharmacokinetics of single and multiple ascending oral PF-05221304 doses, and fructose-stimulated DNL inhibition with repeated oral doses. Healthy subjects (n = 96) received single (1-240 mg) or repeated (2-200 mg daily) doses for 14 days or single 100-mg doses with and without food. PF-05221304 was well tolerated at all doses. Repeated PF-05221304 doses inhibited hepatic DNL in a dose-dependent manner, with near-complete inhibition seen at higher doses. With doses yielding ≥90% DNL inhibition, asymptomatic increases in fasting/postprandial serum triglyceride levels (≥40 mg/day) and declines in platelet count (≥60 mg/day) occurred; these were not observed at ≤80% DNL inhibition. Steady-state pharmacokinetics generally increased dose-proportionally, with a half-life of 14-18 hours and a minimal food effect on plasma exposure. The observed safety and tolerability, pharmacokinetics, and pharmacodynamics support the continued evaluation of PF-05221304 for the treatment of nonalcoholic steatohepatitis.",2020,"Repeated PF-05221304 doses inhibited hepatic DNL in a dose-dependent manner, with near-complete inhibition seen at higher doses.",['Healthy subjects (n\xa0=\xa096'],['Liver-Targeting Acetyl-CoA Carboxylase Inhibitor (PF-05221304'],"['tolerated', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'safety and tolerability, pharmacokinetics, and pharmacodynamics', 'fasting/postprandial serum triglyceride levels', 'platelet count']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0001022', 'cui_str': 'Acetyl Coenzyme A Carboxylase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}]",,0.0259406,"Repeated PF-05221304 doses inhibited hepatic DNL in a dose-dependent manner, with near-complete inhibition seen at higher doses.","[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Bergman', 'Affiliation': 'Pfizer Inc, Early Clinical Development, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Carvajal-Gonzalez', 'Affiliation': 'Pfizer Inc, Early Clinical Development, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sanela', 'Initials': 'S', 'LastName': 'Tarabar', 'Affiliation': 'Pfizer Inc, Clinical Research Unit, New Haven, Connecticut, USA.'}, {'ForeName': 'Aditi R', 'Initials': 'AR', 'LastName': 'Saxena', 'Affiliation': 'Pfizer Inc, Internal Medicine Research Unit, Cambridge, Massachusetts, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Esler', 'Affiliation': 'Pfizer Inc, Internal Medicine Research Unit, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Neeta B', 'Initials': 'NB', 'LastName': 'Amin', 'Affiliation': 'Pfizer Inc, Internal Medicine Research Unit, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.782']
3217,32052925,"A Two-Sequence, Four-Period, Crossover, Replicate Study to Demonstrate Bioequivalence of Warfarin Sodium Tablet in Healthy Chinese Subjects Under Fasting and Fed Conditions.","Warfarin is a narrow therapeutic index anticoagulant drug, and several generic formulations have been approved worldwide. However, there has been no report evaluating the bioequivalence of warfarin sodium according to US Food and Drug Administration draft guidance. We designed a 2-sequence and 4-period crossover study to compare the pharmacokinetic profile and assess bioequivalence between the test warfarin sodium tablet and reference product Coumadin (2.5 mg) in 56 healthy Chinese subjects under fasting and fed conditions. The plasma concentration of warfarin was analyzed by a validated liquid chromatography-tandem mass spectrometry assay, and the reference-scaled procedure was used to determine bioequivalence for the pharmacokinetics parameters. The results showed that the point estimate of geometric mean ratios of C max and AUC 0-t for warfarin were 103.21% and 99.31%, respectively, in the fasting condition and 100.62% and 98.98%, respectively, in the fed condition, and the 90% confidence intervals were all within the range of 90.00%-111.11%. The upper limit of the 90% confidence interval of estimated within-subject variation ratios of the test and reference products was 1.33 for C max and 2.22 for AUC 0-t under the fasting condition and 1.68 for C max and 2.15 for AUC 0-t under the fed condition. Overall, bioequivalence of the 2 warfarin sodium products was demonstrated.",2020,"Overall, bioequivalence of the 2 warfarin sodium products was demonstrated.","['Healthy Chinese Subjects Under Fasting and Fed Conditions', '56 healthy Chinese subjects under fasting and fed conditions']","['Warfarin Sodium Tablet', 'warfarin sodium tablet and reference product Coumadin', 'Warfarin', 'warfarin sodium']","['geometric mean ratios of C max and AUC 0-t for warfarin', 'plasma concentration of warfarin']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0376218', 'cui_str': 'Warfarin Sodium'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0699129', 'cui_str': 'Coumadin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",56.0,0.0243494,"Overall, bioequivalence of the 2 warfarin sodium products was demonstrated.","[{'ForeName': 'Chaoying', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Unit, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Unit, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zirun', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Unit, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Gao', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Unit, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Shili', 'Initials': 'S', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Unit, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lizhi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Qilu Pharmaceutical Co., Ltd., Jinan, China.'}, {'ForeName': 'Yongpeng', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Qilu Pharmaceutical Co., Ltd., Jinan, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Unit, Xuanwu Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Phase I Clinical Trial Unit, Xuanwu Hospital Capital Medical University, Beijing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.783']
3218,32044871,FORGOT CALCIUM? ADMISSION IONIZED-CALCIUM IN TWO CIVILIAN RANDOMIZED CONTROLLED TRIALS OF PRE-HOSPITAL PLASMA FOR TRAUMATIC HEMORRHAGIC SHOCK.,"BACKGROUND
Randomized clinical trials(RCTs) support the use of pre-hospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most pre-hospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent pre-hospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that pre-hospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS
We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation. Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca<1.0mmol/L.
RESULTS
Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34). Pre-hospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Pre-hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03). Severe hypocalcemia was significantly associated with decreased survival(Adjusted Hazard Ratio:1.07;95%CI:1.02-1.13, p=0.01) and massive transfusion(aRR= 2.70;95%CI:1.13-6.46, p=0.03), after adjustment for confounders(randomization group, age, ISS, and shock index).
CONCLUSION
Pre-hospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in pre-hospital hemotherapy.
LEVEL OF EVIDENCE
",2020,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","['Adults with traumatic hemorrhagic shock(SBP≤70 mmHg or 71-90mmHg+HR≥108bpm', 'Of 160 subjects(76% men), 48% received pre-hospital plasma, median age 40years(IQR:28-53), 71% suffered blunt trauma, median ISS=22(IQR:17-34', 'We studied patients enrolled in two institutions participating in pre-hospital plasma RCTs (Control=Standard-of-care; Experimental=Plasma), with i-Ca collected prior to calcium supplementation']",[],"['massive transfusion(aRR', 'Hypocalcemia', 'Severe hypocalcemia', 'rates of hypocalcemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043253', 'cui_str': 'Injuries, Nonpenetrating'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy (regime/therapy)'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",,0.275164,"hospital plasma recipients had significantly higher rates of hypocalcemia compared to controls (53% vs 36%, Adjusted Relative Risk, aRR=1.48; 95%CI: 1.03-2.12, p=0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': 'University of Colorado.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': 'Combat Casualty Care Research Program, US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Neal', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': 'University of Pittsburgh.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': 'University of Colorado.'}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
3219,32039987,Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease: The SuPREMe-CD Study - A Randomized Clinical Trial.,"MINI: In this randomized clinical trial to prevent anastomotic recurrence in Crohn disease, the new Kono-S anastomosis demonstrates a significant reduction in postoperative clinical and endoscopic recurrence rates after ileocolic surgery than conventional side-to-side anastomosis and no safety issues.
OBJECTIVE
This trial aimed to provide randomized controlled data comparing Kono-S anastomosis and stapled ileocolic side-to-side anastomosis.
BACKGROUND
Recently, a new antimesenteric, functional, end-to-end, hand-sewn ileocolic anastomosis (Kono-S) has shown a significant reduction in endoscopic recurrence score and surgical recurrence rate in Crohn disease (CD).
METHODS
Randomized controlled trial (RCT) at a tertiary referral institution. Primary endpoint: endoscopic recurrence (ER) (Rutgeerts score ≥i2) after 6 months. Secondary endpoints: clinical recurrence (CR) after 12 and 24 months, ER after 18 months, and surgical recurrence (SR) after 24 months.
RESULTS
In all, 79 ileocolic CD patients were randomized in Kono group (36) and Conventional group (43). After 6 months, 22.2% in the Kono group and 62.8% in the Conventional group presented an ER [P < 0.001, odds ratio (OR) 5.91]. A severe postoperative ER (Rutgeerts score ≥i3) was found in 13.8% of Kono versus 34.8% of Conventional group patients (P = 0.03, OR 3.32). CR rate was 8% in the Kono group versus 18% in the Conventional group after 12 months (P = 0.2), and 18% versus 30.2% after 24 months (P = 0.04, OR 3.47). SR rate after 24 months was 0% in the Kono group versus 4.6% in the Conventional group (P = 0.3). Patients with Kono-S anastomosis presented a longer time until CR than patients with side-to-side anastomosis (hazard ratio 0.36, P = 0.037). On binary logistic regression analysis, the Kono-S anastomosis was the only variable significantly associated with a reduced risk of ER (OR 0.19, P < 0.001). There were no differences in postoperative outcomes.
CONCLUSIONS
This is the first RCT comparing Kono-S anastomosis and standard anastomosis in CD. The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.ClinicalTrials.gov ID NCT02631967.",2020,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[""Crohn's Disease"", '79 ileocolic CD patients']","['Kono-S anastomosis and stapled ileocolic side-to-side anastomosis', 'MINI']","['SR rate', 'longer time until CR', 'postoperative outcomes', 'postoperative endoscopic and clinical recurrence rate', 'CR rate', 'endoscopic recurrence (ER) ', 'postoperative clinical and endoscopic recurrence rates', 'severe postoperative ER', 'endoscopic recurrence score and surgical recurrence rate', 'clinical recurrence (CR', 'reduced risk of ER', 'surgical recurrence (SR']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0450203', 'cui_str': 'Ileocolic (qualifier value)'}, {'cui': 'C0677619', 'cui_str': 'Side-to-side anastomosis (qualifier value)'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",79.0,0.165843,"The results demonstrate a significant reduction in postoperative endoscopic and clinical recurrence rate for patients who underwent Kono-S anastomosis, and no safety issues.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Luglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Rispo', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Imperatore', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Mariano Cesare', 'Initials': 'MC', 'LastName': 'Giglio', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Amendola', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Francesca Paola', 'Initials': 'FP', 'LastName': 'Tropeano', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peltrini', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Castiglione', 'Affiliation': 'Gastroenterology, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Giovanni Domenico', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Surgical Endoscopy, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Bucci', 'Affiliation': 'Surgery, Department of Clinical Medicine and Surgery, School of Medicine Federico II of Naples, Naples, Italy.'}]",Annals of surgery,['10.1097/SLA.0000000000003821']
3220,27693420,Association Between 6-Minute Walk Test Distance and Objective Variables of Functional Capacity After Exercise Training in Elderly Heart Failure Patients With Preserved Ejection Fraction: A Randomized Exercise Trial.,"OBJECTIVE
To evaluate the change in the 6-minute walk test (6-MWT) distance relative to changes in key functional capacity measures after 16 weeks of exercise training in older patients (≥65y) who have heart failure with preserved ejection fraction (HFpEF).
DESIGN
Prospective, randomized, single-blinded (by researchers to patient group) comparison of 2 groups of HFpEF patients.
SETTING
Hospital and clinic records; ambulatory outpatients.
PARTICIPANTS
Participants (N=47) randomly assigned to an attention control (AC) (n=24) or exercise training (ET) (n=23) group.
INTERVENTION
The ET group performed cycling and walking at 50% to 70% of peak oxygen uptake (V˙o 2 peak) intensity (3d/wk, 60min each session).
MAIN OUTCOME MEASURES
V˙o 2 peak, ventilatory threshold (VT), and 6-MWT distance were measured at baseline and after the 16-week study period.
RESULTS
At follow-up, the 6-MWT distance was higher than at the baseline in both the ET (11%, P=.005) and AC (9%, P=.004) groups. In contrast, V˙o 2 peak and VT values increased in the ET group (19% and 11%, respectively; P=.001), but decreased in the AC group at follow-up (2% and 0%, respectively). The change in V˙o 2 peak versus 6-MWT distance after training was also not significantly correlated in the AC group (r=.01, P=.95) or in the ET group (r=.13, P=.57). The change in 6-MWT distance and VT (an objective submaximal exercise measure) was also not significantly correlated in the AC group (r=.08, P=.74) or in the ET group (r=.16, P=.50).
CONCLUSIONS
The results of this study challenge the validity of using the 6-MWT as a serial measure of exercise tolerance in elderly HFpEF patients and suggest that submaximal and peak exercise should be determined objectively by VT and V˙o 2 peak in this patient population.",2017,"The change in V˙o 2 peak versus 6-MWT distance after training was also not significantly correlated in the AC group (r=.01, P=.95) or in the ET group (r=.13, P=.57).","['Participants (N=47) randomly assigned to an', 'Hospital and clinic records; ambulatory outpatients', 'patient group) comparison of 2 groups of HFpEF patients', 'older patients (≥65y) who have heart failure with preserved ejection fraction (HFpEF', 'Elderly Heart Failure Patients With Preserved Ejection Fraction', 'elderly HFpEF patients']","['Exercise Training', 'exercise training', 'attention control (AC) (n=24) or exercise training (ET', '6-MWT']","['V˙o 2 peak, ventilatory threshold (VT), and 6-MWT distance', '6-MWT distance', '6-MWT distance and VT', 'change in V˙o 2 peak versus 6-MWT distance', '6-minute walk test (6-MWT) distance', '6-Minute Walk Test Distance and Objective Variables of Functional Capacity', 'VT values']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",,0.0525691,"The change in V˙o 2 peak versus 6-MWT distance after training was also not significantly correlated in the AC group (r=.01, P=.95) or in the ET group (r=.13, P=.57).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'Department of Physical Education and Sport, Faculty of Education and Sport-Physical Activity and Sport Section, University of the Basque Country (UPV/EHU), Vitoria-Gasteiz, Araba/Álava, Basque Country, Spain. Electronic address: sara.maldonado@ehu.eus.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Brubaker', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Eggebeen', 'Affiliation': 'Sections on Cardiovascular Medicine and Geriatrics, Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Stewart', 'Affiliation': 'Sections on Cardiovascular Medicine and Geriatrics, Department of Internal Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest School of Medicine, Winston-Salem, NC.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2016.08.481']
3221,32029375,Eye Shielding During Head CT Scans: Dose Reduction and Image Quality Evaluation.,"RATIONALE AND OBJECTIVES
In this study, we assessed the radiation dose to the lens and the impacts of various eye shields using either a fixed or modulated tube current.
MATERIALS AND METHODS
Patients undergoing head computed tomography (CT) examinations were recruited, and each was randomly assigned to one of five imaging groups, either without a CT eye shield or with one of two types of shielding and topogram-based tube current modulation (TCM). The radiation dose at the eye lens was estimated using Gafchromic films. All CT images were analyzed for quality in the orbit and brain areas. Two radiologists also qualitatively assessed image artifacts and their impacts on image quality using three-point Likert scales.
RESULTS
Both barium sulfate and bismuth-antimony shields significantly reduced radiation dose to the lens (by 28.60%-31.92% and 43.87%-47.00%, respectively) while significantly inducing image artifacts. The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding. In addition, discriminating the periocular tissues was improved using a bismuth-antimony shield and topogram-based TCM. Compared to fixed tube current, topogram-based TCM provided better signal-to-noise and contrast-to-noise ratios in the intracranial structures when the bismuth-antimony and barium sulfate shields were applied, respectively.
CONCLUSION
Artifacts resulting from the application of eye shields during head CT examinations can be reduced by using topogram-based TCM instead of a fixed tube current. This could be an alternative approach for maintaining image quality in CT scans that do not encompass organ-based TCM.",2020,"The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding.",['Patients undergoing head computed tomography (CT) examinations'],"['CT eye shield or with one of two types of shielding and topogram-based tube current modulation (TCM', 'barium sulfate and bismuth-antimony', 'bismuth-antimony shield and topogram-based TCM', 'fixed tube current, topogram-based TCM']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0412670', 'cui_str': 'Digital slit-beam radiograph (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0004754', 'cui_str': 'Barium Sulfate'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0202321', 'cui_str': 'Antimony measurement (procedure)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}]",[],,0.0241579,"The image quality of the intraocular structure, but not the intracranial structure, was significantly degraded by shielding.","[{'ForeName': 'Yuan-Hao', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan.'}, {'ForeName': 'Shih-Hung', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yen-Kuang', 'Initials': 'YK', 'LastName': 'Lin', 'Affiliation': 'Biostatistics Center, Taipei Medical University, Taipei, Taiwan; Graduate Institute of Nursing, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Randolph D', 'Initials': 'RD', 'LastName': 'Glickman', 'Affiliation': 'Department of Ophthalmology, University of Texas Health Science Center, San Antonio, Texas.'}, {'ForeName': 'Chia-Yuen', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Wing P', 'Initials': 'WP', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Wan Fang Hospital, Taipei Medical University, 111 Hsing-Long Road, Section 3, Taipei, Taiwan; Department of Radiology, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan. Electronic address: wingchan@tmu.edu.tw.'}]",Academic radiology,['10.1016/j.acra.2019.12.011']
3222,32023185,"Internalized Media-Promoted Body Ideals Only Marginally Moderate the Effects of Exercise on Self-Esteem, Body Image Satisfaction, and Physical Self-Perceptions.","Objective : To examine the moderating effect of internalized media messages on ideal body shape and lifestyle in the relationships between physical exercise, self-esteem, physical self-perceptions, and body image satisfaction. Design : pre-test/posttest control group experimental design. Methods : 46 inactive women (mean age = 21.4 ± 2.1 years-old) volunteered to participate in this study and were randomly assigned to Exercise (n = 23) or Wait-list (n = 23) groups. The Exercise group participated in two 50 minutes long exercise sessions per week for six weeks. During this period women in the Wait-list group did not participate in any regular physical activity. The French version of the Physical Self-Perception Profile (ISP-25) and the Body Image Assessment Scale (BIAS-BD) were administered to participants before and after intervention. In addition, the Sociocultural Attitudes Toward Appearance Questionnaire (SATAQ) was completed to assess participants' level of internalization of media standards. Results and Discussion : Women in the Exercise group improved more in outcomes than those in the Wait-list group. Effects were only marginally moderated by levels of media internalization. Potential explanations for these findings are reviewed and discussed.",2020,The French version of the Physical Self-Perception Profile (ISP-25) and the Body Image Assessment Scale (BIAS-BD) were administered to participants before and after intervention.,['Methods : 46 inactive women (mean age\xa0=\xa021.4\xa0±\xa02.1\xa0years-old'],"['internalized media messages', 'Internalized Media-Promoted Body Ideals', 'Discussion ']","['Sociocultural Attitudes Toward Appearance Questionnaire (SATAQ', 'Physical Self-Perception Profile (ISP-25) and the Body Image Assessment Scale (BIAS-BD', 'levels of media internalization', 'Self-Esteem, Body Image Satisfaction, and Physical Self-perceptions', 'physical exercise, self-esteem, physical self-perceptions, and body image satisfaction']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",46.0,0.0226989,The French version of the Physical Self-Perception Profile (ISP-25) and the Body Image Assessment Scale (BIAS-BD) were administered to participants before and after intervention.,"[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Legrand', 'Affiliation': 'University of Reims Champagne-Ardenne.'}, {'ForeName': 'Gwendoline', 'Initials': 'G', 'LastName': 'Silete', 'Affiliation': 'University of Reims Champagne-Ardenne.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Schiffler', 'Affiliation': 'University of Reims Champagne-Ardenne.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1706713']
3223,32009110,Prevention of Atherosclerosis by the Induction of Microbial Polyamine Production in the Intestinal Lumen.,"Low molecular weight metabolites produced by the intestinal microbiome that have been associated with health and disease as metabolites need to be constantly absorbed from the intestinal lumen and transported to intestinal epithelial cells and blood. Polyamines, especially spermidine and spermine, are bioactive chemicals which promote autophagy and suppress inflammation. The main source of exogenous polyamines is the intestinal lumen, where they are produced by intestinal microbiome. Considering the intestinal microbiome as a manufacturing plant for bioactive substances, we developed a novel hybrid putrescine biosynthesis system strategy, in which the simultaneous intake of Bifidobacterium animalis ssp. lactis LKM512 (Bifal) and arginine (Arg) upregulates the production of the putrescine, a precursor of spermidine and spermine, in the gut by controlling the bacterial metabolism beyond its vast diversity and inter-individual differences. In a clinical trial, healthy individuals with a body mass index near the maximum ""healthy"" range (25 kg/m 3 ; n = 44) were randomized to consume either normal yogurt containing Bifal and Arg (Bifal + Arg YG) or placebo (normal yogurt) for 12 weeks. The change in reactive hyperemia index determined by EndoPAT from week 0 to 12 in the Bifal + Arg YG group was significantly higher than that in the placebo group, indicating that Bifal + Arg YG intake improved vascular endothelial function. In addition, the concentrations of fecal putrescine and serum spermidine in the Bifal+ Arg YG group were significantly higher than those in the placebo group. These findings suggest that consuming Bifal + Arg YG prevents or reduces atherosclerosis risk by upregulating blood spermidine levels, which subsequently induces autophagy.",2020,"In addition, the concentrations of fecal putrescine and serum spermidine in the Bifal+ Arg YG group were significantly higher than those in the placebo group.","['healthy individuals with a body mass index near the maximum ""healthy"" range (25\u2009kg/m 3 ; n\u2009=\u200944']","['lactis LKM512 (Bifal) and arginine (Arg', 'placebo', 'normal yogurt containing Bifal and Arg (Bifal\u2009+\u2009Arg YG) or placebo']","['concentrations of fecal putrescine and serum spermidine', 'atherosclerosis risk', 'reactive hyperemia index', 'vascular endothelial function']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0968133', 'cui_str': 'alpha-(trifluoromethyl)arginine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034170', 'cui_str': 'Tetramethylenediamine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037871', 'cui_str': 'spermidine'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031843', 'cui_str': 'function'}]",44.0,0.0780525,"In addition, the concentrations of fecal putrescine and serum spermidine in the Bifal+ Arg YG group were significantly higher than those in the placebo group.","[{'ForeName': 'Mitsuharu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Dairy Science and Technology Institute, Kyodo Milk Industry Co., Ltd.'}]",Biological & pharmaceutical bulletin,['10.1248/bpb.b19-00855']
3224,31767374,Orthopedic treatment and early weight-bearing for bimalleolar ankle fractures in elderly patients: Quality of life and complications.,"INTRODUCTION
Non-operative treatment of Weber's type B ankle fractures is essential in elderly patients. However, there is controversy in the post-reduction management of the fracture between the use of early weight-bearing or traditional treatment and non-weight-bearing for 6-8 weeks. There is limited evidence available regarding which rehabilitation regimen should be included. This study aimed to compare the quality of life and the number of complications between the two types of intervention (weight-bearing and non-weight-bearing).
METHODS
Prospective cohort study. The quality of life was analyzed through the SF-12 and the Barthel Index at 6 weeks, one year and two years. The mean age was 83 ± 3 years in the weight-bearing group and 82 ± 3 in the non-weight-bearing group. In addition, the associated complications and costs were analyzed.
RESULTS
A total of 70 patients were assigned in two groups: a control group of 37 patients (nonweight-bearing) and an experimental group of 33 patients (weight-bearing). A significant difference was observed in favor of early weight-bearing in SF-12 both, in the short and long terms (52.9 ± 5.3 vs 64.9 ± 4.6; p < 0.001 and 69.8 ± 4.1 vs 81.0 ± 3.6; p < 0.001). Significant differences were also observed in favor of early loading with respect to the Barthel Index (54.3 ± 4.9 vs 64.2 ± 3.9; p < 0.001 and 70.6 ± 4.2 vs 80.4 ± 3.0; p < 0.001). There were no significant differences in the complication rate between the two groups.
CONCLUSION
Early weight-bearing improves the quality of life and functionality in elderly patients with Weber type B fracture without increasing complications.",2020,"A significant difference was observed in favor of early weight-bearing in SF-12 both, in the short and long terms (52.9 ± 5.3 vs 64.9 ± 4.6; p < 0.001 and 69.8 ± 4.1 vs 81.0 ± 3.6; p < 0.001).","['elderly patients', 'The mean age was 83\xa0±\xa03 years in the weight-bearing group and 82\xa0±\xa03 in the non-weight-bearing group', 'elderly patients with Weber type B fracture without increasing complications', '70 patients']",['Orthopedic treatment and early weight-bearing for bimalleolar ankle fractures'],"['quality of life and the number of complications', 'early weight-bearing in SF-12', 'quality of life', 'quality of life and functionality', 'complication rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445100', 'cui_str': 'Non-weight-bearing (finding)'}, {'cui': 'C0559837', 'cui_str': 'Weber type B fracture (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0435908', 'cui_str': 'Bimalleolar Equivalent Fractures'}]","[{'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}]",70.0,0.0391843,"A significant difference was observed in favor of early weight-bearing in SF-12 both, in the short and long terms (52.9 ± 5.3 vs 64.9 ± 4.6; p < 0.001 and 69.8 ± 4.1 vs 81.0 ± 3.6; p < 0.001).","[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lorente', 'Affiliation': 'Department of Traumatology and Orthopaedic Surgery, University Hospital Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Palacios', 'Affiliation': 'Department of Traumatology and Orthopaedic Surgery, University Hospital Madrid Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Lorente', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology, University Hospital of Badajoz, Badajoz, Spain. Electronic address: gonzalo.mariscal@mail.ucv.es.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Mariscal', 'Affiliation': 'Institute for Research on Musculoskeletal Disorders, School of Medicine, Valencia Catholic University, Valencia 46001, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Institute for Research on Musculoskeletal Disorders, School of Medicine, Valencia Catholic University, Valencia 46001, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gandía', 'Affiliation': 'Department of Traumatology and Orthopaedic Surgery, University Hospital Ramón y Cajal, Madrid, Spain.'}]",Injury,['10.1016/j.injury.2019.11.028']
3225,31859096,The effect of aromatherapy massage with lavender and chamomile oil on anxiety and sleep quality of patients with burns.,"INTRODUCTION
Regarding the importance of anxiety management and improvement of the quality of sleep in patients with burn injuries, this study aimed to determine the effect of aromatherapy massage (using aromatic oils of lavender and chamomile) on the anxiety and sleep quality of the patients with burn injuries.
METHOD
In a quasi-experimental study, 105 patients with burns were recruited by convenience sampling method and then assigned into three groups (control, placebo massage, and combined aromatic oil massage). The study intervention was performed 20min before bedtime in three sessions, within a week. The control group was only under daily routine care. The study data were collected using the Persian version of Spielberg's anxiety scale and the Pittsburgh Sleep Quality Inventory. Descriptive and inferential statistical tests were used to analyze the data in SPSS version 20.
RESULTS
The results showed a significant difference among the three groups in terms of anxiety score (P<0.001) and in terms of sleep quality after the intervention (P=0.027).
CONCLUSION
Since the aromatherapy massage as a non-pharmacological and simple method can improve the anxiety and quality of sleep in patients with burns, it is suggested that nurses and burn medical care team apply it to reduce burn patients' anxiety and promote their sleep quality. Applying massage alone also reduces anxiety in burn survivors.",2020,"The results showed a significant difference among the three groups in terms of anxiety score (P<0.001) and in terms of sleep quality after the intervention (P=0.027).
","['patients with burn injuries', 'burn survivors', '105 patients with burns', 'patients with burns']","['aromatherapy massage (using aromatic oils of lavender and chamomile', 'placebo massage, and combined aromatic oil massage', 'aromatherapy massage with lavender and chamomile oil', 'aromatherapy massage']","[""Persian version of Spielberg's anxiety scale and the Pittsburgh Sleep Quality Inventory"", 'sleep quality', 'quality of sleep', 'anxiety', 'anxiety and sleep quality', 'anxiety and quality of sleep', 'anxiety score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C2585844', 'cui_str': 'Aromatherapy massage (regime/therapy)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0524903', 'cui_str': 'Lavender'}, {'cui': 'C0752226', 'cui_str': 'Chamomile'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0109265', 'cui_str': 'Chamomile Flower Oil'}]","[{'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",105.0,0.0176718,"The results showed a significant difference among the three groups in terms of anxiety score (P<0.001) and in terms of sleep quality after the intervention (P=0.027).
","[{'ForeName': 'Forough', 'Initials': 'F', 'LastName': 'Rafii', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ameri', 'Affiliation': 'Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Ameri.farzaneh@gmail.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatics, School of Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghobadi', 'Affiliation': 'Department of Traditional Medicine, School of Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Burns : journal of the International Society for Burn Injuries,['10.1016/j.burns.2019.02.017']
3226,32023184,Metabolic Demand and Indirect Markers of Muscle Damage After Eccentric Cycling With Blood Flow Restriction.,"Purpose : To compare the effects of a single bout of eccentric cycling (ECC) and eccentric cycling with blood flow restriction (ECC BFR ) on the changes in cardio-metabolic demand and indirect markers of muscle damage in healthy men. Method : Twenty-one young men (24.0 ± 3.2 y) were randomly allocated in two groups to perform a 30-min eccentric cycling bout with or without blood flow restriction. Oxygen consumption, heart rate, rate of perceived exertion and mean arterial blood pressure were monitored during cycling. Blood lactate was measured before and after cycling. Maximal voluntary isometric knee extensor strength and muscle damage were measured before, immediately after and 1-4 days after each eccentric cycling bout. Results : Oxygen consumption, heart rate, rate of perceived exertion and mean arterial blood pressure were similar between bouts. Blood lactate concentrations increased in both groups ( p < .01), with ECC BFR showing 60% greater blood lactate concentration than eccentric cycling ( p < .01). Maximal voluntary isometric knee extensor strength decreased 19-7% until 48 h and decreased 16-7% until 72 h after ECC and ECC BFR , respectively. Muscle soreness and pressure pain threshold remained elevated until 72 h after ECC and until 96 h after ECC BFR . Conclusion : These results show that ECC BFR induces similar cardiovascular stress, greater lactate production and longer time to recover than ECC alone. Thus, BFR can be safely implemented with eccentric cycling.",2020,"Blood lactate concentrations increased in both groups ( p < .01), with ECC BFR showing 60% greater blood lactate concentration than eccentric cycling ( p < .01).","['Method : Twenty-one young men (24.0 ± 3.2 y', 'healthy men']","['30-min eccentric cycling bout with or without blood flow restriction', 'Eccentric Cycling with Blood Flow Restriction', 'single bout of eccentric cycling (ECC) and eccentric cycling with blood flow restriction (ECC BFR ', 'ECC BFR']","['Blood lactate concentrations', 'Muscle soreness and pressure pain', 'Blood lactate', 'Oxygen consumption, heart rate, rate of perceived exertion and mean arterial blood pressure', 'Maximal voluntary isometric knee extensor strength and muscle damage', 'cardiovascular stress, greater lactate production', 'blood lactate concentration', 'Maximal voluntary isometric knee extensor strength']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517687', 'cui_str': '3.2'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4077283', 'cui_str': '(67Ga)ECC'}]","[{'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0033268'}]",21.0,0.0271952,"Blood lactate concentrations increased in both groups ( p < .01), with ECC BFR showing 60% greater blood lactate concentration than eccentric cycling ( p < .01).","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Penailillo', 'Affiliation': 'Universidad Finis Terrae.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Santander', 'Affiliation': 'Universidad Finis Terrae.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Zbinden-Foncea', 'Affiliation': 'Universidad Finis Terrae.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Jannas-Vela', 'Affiliation': 'Universidad Finis Terrae.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1699234']
3227,31030229,"Clinical efficacy and safety of flexible ureteroscopic lithotripsy using 365 μm holmium laser for nephrolithiasis: a prospective, randomized, controlled trial.","PURPOSE
To compare the clinical efficacy and safety between the FURL with 365 μm and 200 μm holmium laser for treating nephrolithiasis.
MATERIALS AND METHODS
A prospective randomized controlled trial was performed including analysis of data from 200 patients with nephrolithiasis. A total of 180 patients were randomized into two groups according to 1:1 ratio. In the 365 μm holmium laser group, kidney stones were disintegrated into less than 2 mm fragments with a 365 µm holmium laser fiber with the settings of 30-45 W under direct visualization; in the control group, the conventional 200 μm holmium laser was used. Descriptive statistics and logistic regression analyses tested the association among operation time, stone-free rate (SFR) and incidence of complications.
RESULTS
Operation time in the FURL with 365 μm laser was significantly shortened and no significance was observed in the complication rate. Stone size and location were identified as two major confounding factors for the operation time and SFR. Moreover, the FURL using 365 μm laser showed less operation time for renal stones with the diameter between 1 and 2 cm, stones located in lower calyx and multiple calculi; stones larger than 2 cm and/or located in lower pole inclined to present better SFR using the FURL with 365 μm laser.
CONCLUSIONS
The FURL combined with 365 μm holmium laser is safer and highly efficacious for the management of nephrolithiasis when compared to conventional FURL procedures, especially for those located in lower pole and larger than 2 cm.",2020,"The FURL combined with 365 μm holmium laser is safer and highly efficacious for the management of nephrolithiasis when compared to conventional FURL procedures, especially for those located in lower pole and larger than 2 cm.","['A total of 180 patients', '365\xa0μm holmium laser for nephrolithiasis', '200 patients with nephrolithiasis']","['holmium laser', 'conventional 200\xa0μm holmium laser', 'FURL with 365\xa0μm and 200\xa0μm holmium laser', 'flexible ureteroscopic lithotripsy', 'holmium laser fiber with the settings of 30-45\xa0W under direct visualization']","['operation time, stone-free rate (SFR) and incidence of complications', 'operation time for renal stones', 'clinical efficacy and safety', 'kidney stones', 'Operation time', 'complication rate', 'Clinical efficacy and safety']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0392525', 'cui_str': 'Nephrolithiasis'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1955839', 'cui_str': 'Holmium Lasers'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}]",180.0,0.0270909,"The FURL combined with 365 μm holmium laser is safer and highly efficacious for the management of nephrolithiasis when compared to conventional FURL procedures, especially for those located in lower pole and larger than 2 cm.","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Keliang', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Ningbo First Hospital, Ningbo, 315000, China.'}, {'ForeName': 'Zijie', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Rijin', 'Initials': 'R', 'LastName': 'Song', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Jiexiu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Bianjiang', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Guohua', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510230, China.'}, {'ForeName': 'Zengjun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China. njmuwzj@qq.com.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gu', 'Affiliation': 'Department of Urology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China. lancetgu@aliyun.com.'}]",World journal of urology,['10.1007/s00345-019-02776-w']
3228,31848812,Health-Related Quality of Life After Cytoreductive Surgery/HIPEC for Mucinous Appendiceal Cancer: Results of a Multicenter Randomized Trial Comparing Oxaliplatin and Mitomycin.,,2020,,['Mucinous Appendiceal Cancer'],"['Cytoreductive Surgery/HIPEC', 'Oxaliplatin and Mitomycin']",['Health-Related Quality of Life'],"[{'cui': 'C0496779', 'cui_str': 'Appendiceal Cancer'}]","[{'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0691131,,"[{'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Tun', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Oliver S', 'Initials': 'OS', 'LastName': 'Eng', 'Affiliation': 'Department of Surgery, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Malec', 'Affiliation': 'Department of Medicine, University of Chicago, Chicago, IL, USA. mmalec@medicine.bsd.uchicago.edu.'}]",Annals of surgical oncology,['10.1245/s10434-019-08106-z']
3229,31711275,Adherence and barriers in e-health self-control training for enhancing childhood multidisciplinary obesity treatment.,"Training self-control as the assumed underlying mechanism for weight loss is a promising pathway for improving long-term outcomes of childhood multidisciplinary obesity treatment (MOT). The present study is the first to analyse adherence to e-health self-control training in paediatric obesity. We hypothesized that low adherence would relate to child characteristics and to contextual treatment barriers. Participants were recruited as a part of a larger randomized controlled trial, evaluating an e-health self-control training during inpatient MOT (intensive phase) and its outpatient aftercare (booster phase). A number of 68 youngsters with severe obesity between 11 to 19 years old were included in the present study. Excellent adherence was observed in the intensive phase during inpatient MOT, but rates decreased in the booster phase. As predicted, the low adherence group had a significantly higher weight status throughout the entire study period. Differences in contextual treatment barriers did not appear. Further in-depth analysis showed that the low adherence group frequently experienced practical obstacles. The end of inpatient MOT and high weight status can be considered important risk factors for low adherence in an additional self-control training aimed at facilitating weight loss.",2020,Differences in contextual treatment barriers did not appear.,"['68 youngsters with severe obesity between 11 to 19 years old were included in the present study', 'paediatric obesity']","['e-health self-control training during inpatient MOT (intensive phase) and its outpatient aftercare (booster phase', 'control training']","['weight status', 'Excellent adherence']","[{'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}]",,0.0172087,Differences in contextual treatment barriers did not appear.,"[{'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Naets', 'Affiliation': 'Department of Developmental, Personality and Social Psychology, Ghent University, Gent, Belgium.'}, {'ForeName': 'Leentje', 'Initials': 'L', 'LastName': 'Vervoort', 'Affiliation': 'Department of Developmental, Personality and Social Psychology, Ghent University, Gent, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Tanghe', 'Affiliation': 'Obesity Department, Psychology, Zeepreventorium vzw, De Haan, Belgium.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Braet', 'Affiliation': 'Department of Developmental, Personality and Social Psychology, Ghent University, Gent, Belgium.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2405']
3230,31742460,Development and Pretesting of Risk-Based Mobile Multimedia Message Content for Young Adult Hookah Use.,"Background . Hookah is one of the most commonly used tobacco products among U.S. young adults due in part to widespread misperceptions that it is not harmful or addictive. There is growing evidence that hookah tobacco is associated with health harms and can lead to addiction. Research on interventions to address these misperceptions by communicating the harms and addictiveness of hookah use is needed. Aims . This study developed and pretested mobile multimedia message service (MMS) message content communicating the risks of hookah tobacco use to young adult hookah smokers. Method . Message content, delivery, and pretesting were tailored to participants' risk beliefs, hookah use frequency, and responses to simulated text message prompts. Participants viewed 4 of 12 core MMS messages randomized within-subjects and completed postexposure measures of message receptivity and emotional response (e.g., worry). Results . The sample included 156 young adult (age 18-30 years) hookah smokers; 31% smoked hookah monthly and 69% weekly/daily. Prior to viewing messages, a majority endorsed beliefs reflecting misperceptions about the risks of hookah tobacco. Postexposure measures showed participants were receptive to the messages and the messages evoked emotional response. As anticipated, messages produced similar receptivity and there were few differences in emotional response between the messages tested. Discussion . Young adult hookah tobacco smokers were receptive to tailored mobile MMS messages and messages evoked emotional response, two critical precursors to behavior change. Conclusion . Findings indicate that research testing the efficacy of tailored MMS messaging as a strategy for reducing hookah tobacco use in young adults is warranted.",2019,"Young adult hookah tobacco smokers were receptive to tailored mobile MMS messages and messages evoked emotional response, two critical precursors to behavior change. ","['Young Adult Hookah Use', 'young adults', 'young adult hookah smokers', 'Young adult hookah tobacco smokers', '156 young adult (age 18-30 years) hookah smokers; 31% smoked hookah monthly and 69% weekly/daily']","['tailored MMS messaging', 'pretested mobile multimedia message service (MMS) message content communicating the risks of hookah tobacco']","['emotional response', 'message receptivity and emotional response (e.g., worry']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4302493', 'cui_str': 'Smoking Water Pipes'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4505132', 'cui_str': 'Hookah Tobacco'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4505132', 'cui_str': 'Hookah Tobacco'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}]",156.0,0.040301,"Young adult hookah tobacco smokers were receptive to tailored mobile MMS messages and messages evoked emotional response, two critical precursors to behavior change. ","[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Johnson', 'Affiliation': 'Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Lipkus', 'Affiliation': 'Duke University School of Nursing, Durham, NC, USA.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Tercyak', 'Affiliation': 'Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Luta', 'Affiliation': 'Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rehberg', 'Affiliation': 'Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Lilianna', 'Initials': 'L', 'LastName': 'Phan', 'Affiliation': 'Georgetown University Medical Center, Washington, DC, USA.'}, {'ForeName': 'Lorien C', 'Initials': 'LC', 'LastName': 'Abroms', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Mays', 'Affiliation': 'Georgetown University Medical Center, Washington, DC, USA.'}]",Health education & behavior : the official publication of the Society for Public Health Education,['10.1177/1090198119874841']
3231,32014358,Deprescribing potentially inappropriate medications in memory clinic patients (DePIMM): A feasibility study.,"BACKGROUND
Medication-related problems and inappropriate medication use are prevalent among people attending memory clinics. There have been no deprescribing intervention studies in this setting.
OBJECTIVE
To evaluate the feasibility of a pharmacist-led interdisciplinary deprescribing intervention study in a memory clinic.
METHODS
A pre-post-intervention study conducted at an outpatient memory clinic of an Australian tertiary care public hospital. Participants were English-speaking, community-dwelling patients identified as being at risk of a medication-related problem, or their carers. Participants received a medication review in their home from a consultant pharmacist who collaborated with the patient/carer, memory clinic, general practitioner and community pharmacist to develop a plan for optimising medication use. The primary outcome was feasibility, based on i) proportion of memory clinic patients eligible for the study, ii) proportion of eligible patients who consented, and iii) proportion of pharmacist-identified inappropriate/unnecessary medications that were deprescribed (reduced or ceased) at six months.
RESULTS
One-third of memory clinic patient/carers were eligible (n = 82/238), 61% (n = 50/82) consented to participate. The median (IQR) age of participants who received the intervention (n = 46) was 80.5 (71.5-85.0) years and median (IQR) number of medications was 11 (8.0-13.3). Pharmacists recommended deprescribing 124 medications, and 53 (42.7%) had been ceased or dose-reduced at six months.
CONCLUSION
It was feasible to recruit study participants and deliver a pharmacist-led interdisciplinary deprescribing intervention in this memory clinic setting. A larger, multi-centre study with longer follow-up is needed to confirm effectiveness and clinical outcomes.",2020,"Pharmacists recommended deprescribing 124 medications, and 53 (42.7%) had been ceased or dose-reduced at six months.
","['A pre-post-intervention study conducted at an outpatient memory clinic of an Australian tertiary care public hospital', 'One-third of memory clinic patient/carers were eligible (n\xa0=\xa082/238), 61% (n\xa0=\xa050/82) consented to participate', 'memory clinic patients (DePIMM', 'Participants were English-speaking, community-dwelling patients identified as being at risk of a medication-related problem, or their carers', 'people attending memory clinics']","['medication review in their home from a consultant pharmacist who collaborated with the patient/carer, memory clinic, general practitioner and community pharmacist to develop a plan for optimising medication use', 'pharmacist-led interdisciplinary deprescribing intervention']","['feasibility, based on i) proportion of memory clinic patients eligible for the study, ii) proportion of eligible patients who consented, and iii) proportion of pharmacist-identified inappropriate/unnecessary medications']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C4316447', 'cui_str': 'Consultant pharmacist'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0402003', 'cui_str': 'Community Pharmacists'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4046040', 'cui_str': 'Deprescribing'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}]",,0.072871,"Pharmacists recommended deprescribing 124 medications, and 53 (42.7%) had been ceased or dose-reduced at six months.
","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Cross', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia; Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Johnson', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Woodward', 'Affiliation': 'Medical and Cognitive Research Unit, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Vivien J', 'Initials': 'VJ', 'LastName': 'Le', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia.'}, {'ForeName': 'Rohan A', 'Initials': 'RA', 'LastName': 'Elliott', 'Affiliation': 'Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia; Pharmacy Department, Austin Health, Heidelberg, Victoria, Australia. Electronic address: rohan.elliott@austin.org.au.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2020.01.010']
3232,29910050,"The effect of Aliskiren on exercise capacity in older patients with heart failure and preserved ejection fraction: A randomized, placebo-controlled, double-blind trial.","In older patients (70 ± 7 years) with chronic well-compensated heart failure with preserved ejection and controlled blood pressure, 6 months treatment with aliskiren (direct renin inhibitor) showed non-significant trends for modest improvements in peak exercise oxygen consumption (14.9 ± 0.2 mL kg -1 min -1 versus 14.4 ± 0.2 mL kg -1 min -1 ; P = .10, trend) and ventilatory anaerobic threshold (888 ± 19 mL/min versus 841 ± 18 mL/min; P = .08).",2018,"In older patients (70 ± 7 years) with chronic well-compensated heart failure with preserved ejection and controlled blood pressure, 6 months treatment with aliskiren (direct renin inhibitor) showed non-significant trends for modest improvements in peak exercise oxygen consumption (14.9 ± 0.2 mL kg -1 min -1 versus 14.4 ± 0.2 mL kg -1 min -1 ; P = .10, trend) and ventilatory anaerobic threshold (888 ± 19 mL/min versus 841 ± 18 mL/min; P = .08).","['older patients (70 ± 7 years) with chronic well-compensated heart failure with preserved ejection and controlled blood pressure, 6 months treatment with', 'older patients with heart failure and preserved ejection fraction']","['Aliskiren', 'aliskiren (direct renin inhibitor', 'placebo']","['ventilatory anaerobic threshold', 'peak exercise oxygen consumption', 'exercise capacity']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1120110', 'cui_str': 'aliskiren'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3653375', 'cui_str': 'Renin-inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",,0.284855,"In older patients (70 ± 7 years) with chronic well-compensated heart failure with preserved ejection and controlled blood pressure, 6 months treatment with aliskiren (direct renin inhibitor) showed non-significant trends for modest improvements in peak exercise oxygen consumption (14.9 ± 0.2 mL kg -1 min -1 versus 14.4 ± 0.2 mL kg -1 min -1 ; P = .10, trend) and ventilatory anaerobic threshold (888 ± 19 mL/min versus 841 ± 18 mL/min; P = .08).","[{'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Upadhya', 'Affiliation': 'Cardiovascular Medicine Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Brubaker', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Morgan', 'Affiliation': 'Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Eggebeen', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Geoffrey T', 'Initials': 'GT', 'LastName': 'Jao', 'Affiliation': 'Cardiovascular Medicine Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Stewart', 'Affiliation': 'Cardiovascular Medicine Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Cardiovascular Medicine Section, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC. Electronic address: dkitzman@wakehealth.edu.'}]",American heart journal,['10.1016/j.ahj.2018.03.019']
3233,32027206,Can Visual Art Therapy Be Implemented With Illiterate Older Adults With Mild Cognitive Impairment? A Pilot Mixed-Method Randomized Controlled Trial.,"Older adults with mild cognitive impairment (MCI) with no literacy are at increased risk of progression to dementia. Whether it is feasible to engage this population in visual art therapy (VAT) and yield effects on cognition and depression remained unclear. A pilot mixed-method single-blinded randomized controlled trial was conducted in a sample of community-dwelling older adults with MCI. The experimental group (n = 21) was assigned to 12 sessions of VAT over 6 weeks, and the control group (n = 18) was assigned to 6 weekly health education (HE) on nonbrain health topics. Participants were evaluated at baseline using Montreal Cognitive Assessment-5-minute protocol (MoCA-5-min) and Geriatric Depression Scale Short Form (GDS-SF). A focus group discussion (FGD) was also conducted to the experimental group to explore their experiences of participating in the VAT. Findings indicated that both VAT and HE groups had significant improvement in MoCA-5-min scores and depressed mood over time; however, the significant group × time interaction effect was noted only for the psychological outcome. Findings from the FGD indicated that participants had challenging experiences at the beginning of the therapy, but later, they were able to cope and found that the VAT was relevant and beneficial for their cognitive and psychosocial health. This pilot study provided initial evidence about the potential benefit of VAT in improving cognitive and psychological well-being of older adults with MCI and low literacy and provided insights on how to better engage them in this cognitive stimulating intervention. A full-scale trial is recommended for a stringent evaluation.",2021,"Findings indicated that both VAT and HE groups had significant improvement in MoCA-5-min scores and depressed mood over time; however, the significant group × time interaction effect was noted only for the psychological outcome.","['Older adults with mild cognitive impairment (MCI', 'Illiterate Older Adults With Mild Cognitive Impairment', 'sample of community-dwelling older adults with MCI', 'older adults with MCI and low literacy']","['6 weekly health education (HE) on nonbrain health topics', 'VAT']","['MoCA-5-min scores', 'time interaction effect', 'Montreal Cognitive Assessment-5-minute protocol (MoCA-5-min) and Geriatric Depression Scale Short Form (GDS-SF']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0752151', 'cui_str': 'VATS'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3496286'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}]",21.0,0.0651201,"Findings indicated that both VAT and HE groups had significant improvement in MoCA-5-min scores and depressed mood over time; however, the significant group × time interaction effect was noted only for the psychological outcome.","[{'ForeName': 'Golden M', 'Initials': 'GM', 'LastName': 'Masika', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, 26451Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Doris S F', 'Initials': 'DSF', 'LastName': 'Yu', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, 26451The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Polly W C', 'Initials': 'PWC', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Li Ka Shing Faculty of Medicine, 26451The University of Hong Kong, Hong Kong.'}]",Journal of geriatric psychiatry and neurology,['10.1177/0891988720901789']
3234,32006071,Impact of an informational flipchart on lifestyle advice for Nepali women with a pelvic organ prolapse: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS
Pelvic floor muscle training (PFMT) and lifestyle advice are effective at improving the symptoms and severity of pelvic organ prolapse (POP) in a range of populations; however, the impact of these interventions in Nepali women is unknown. We aimed to evaluate the impact of an informational flipchart on PFMT and lifestyle advice on the quality of life (QOL) for Nepali women with a POP.
METHODS
This prospective randomized controlled trial recruited 140 women with a stage I-III POP from Kathmandu Valley. The intervention group were instructed on PFMT and lifestyle advice through an informational flipchart and the control group were provided usual care. The primary outcome measure was the Prolapse Quality of Life questionnaire (P-QOL) and was completed at baseline, 6 weeks, 12 weeks and 6 months. The secondary outcome measure was the Pelvic Organ Prolapse Quantification (POP-Q) system and Modified Oxford Scale (MOS) assessed by clinical examination at baseline and 6 months. Differences in mean P-QOL scores for each domain were evaluated using analysis of covariance.
RESULTS
Compared with usual care, the women in the informational flipchart group experienced significant improvement in six of the nine P-QOL domains and for the prolapse, bladder and bowel symptoms. Only a small percentage (20%) of women were able to attend the 6-month clinical assessment so we were unable to assess the secondary outcomes.
CONCLUSIONS
A one-time intervention of an informational flipchart on PFMT and lifestyle advice is effective at improving QOL and symptoms for Nepali women with a stage I-III POP.",2020,A one-time intervention of an informational flipchart on PFMT and lifestyle advice is effective at improving QOL and symptoms for Nepali women with a stage I-III POP.,"['Nepali women with a stage I-III POP', 'Nepali women with a pelvic organ prolapse', '140 women with a stage I-III POP from Kathmandu Valley', 'Nepali women with a POP']","['Pelvic floor muscle training (PFMT) and lifestyle advice', 'PFMT and lifestyle advice through an informational flipchart and the control group were provided usual care', 'informational flipchart on PFMT and lifestyle advice', 'informational flipchart']","['quality of life (QOL', 'QOL and symptoms', 'Prolapse Quality of Life questionnaire (P-QOL', 'nine P-QOL domains', 'Pelvic Organ Prolapse Quantification (POP-Q) system and Modified Oxford Scale (MOS) assessed by clinical examination', 'lifestyle advice', 'mean P-QOL scores', 'prolapse, bladder and bowel symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0563004', 'cui_str': 'Valley (environment)'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}]",140.0,0.135749,A one-time intervention of an informational flipchart on PFMT and lifestyle advice is effective at improving QOL and symptoms for Nepali women with a stage I-III POP.,"[{'ForeName': 'Delena', 'Initials': 'D', 'LastName': 'Caagbay', 'Affiliation': 'Discipline of Obstetrics and Gynaecology and Neonatology, The University of Sydney, Sydney, Australia. dcaa7602@uni.sydney.edu.au.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Raynes-Greenow', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Dangal', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kathmandu Model Hospital, Kathmandu, Nepal.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mc Geechan', 'Affiliation': 'Sydney School of Public Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kirsten I', 'Initials': 'KI', 'LastName': 'Black', 'Affiliation': 'Discipline of Obstetrics and Gynaecology and Neonatology, The University of Sydney, Sydney, Australia.'}]",International urogynecology journal,['10.1007/s00192-020-04228-1']
3235,31197249,"Potential roles of Helicobacter pylori treatment, body mass index and waist circumference in the causation of erosive esophagitis: a randomized clinical trial (HEROES-GERD).","BACKGROUND
In recent decades, the prevalence of gastroesophageal reflux disease (GERD) and obesity has been increasing while Helicobacter pylori infection has been decreasing.
OBJECTIVE
To evaluate if H. pylori treatment, excess body weight and other anthropometric measurements are associated with incident erosive esophagitis, as a secondary objective of a trial which tested the efficacy of treatment of H. pylori on the symptoms of functional dyspepsia.
SUBJECTS/METHODS
Upper gastrointestinal endoscopy and anthropometric assessments were performed, at baseline and after 12 months, in H. pylori positive patients with functional dyspepsia who had no baseline reflux symptoms or esophagitis. Patients were randomly assigned to receive omeprazole, amoxicillin, and clarithromycin (antibiotic group; n = 201) or omeprazole plus placebo (control group; n = 203). The primary outcome was the incidence of esophagitis 12 months after randomization, according to treatment groups, and the association of BMI and other anthropometric measurements.
RESULTS
Four hundred and four patients were included (mean age, 46.1 years; 78.7% women). The 12-month follow-up endoscopic esophagitis rates for the antibiotic and control groups were 10.9% (22/201) and 9.4% (19/203), respectively (p = 0.60). The number needed to harm was 67. Baseline anthropometric measurements were performed in 94% (380/404) of patients. The 12-month follow-up esophagitis rates for overweight and normal body weight patients were 13.6% (29/213) and 6.0% (10/167), respectively (p = 0.015); rates for patients with and without increased baseline waist circumference were 15.4% (24/156) and 6.7% (15/224), respectively (p = 0.006). Following logistic regression, only the combination of increased baseline body mass index and waist, but not H. pylori treatment, was independently associated with new-onset esophagitis (OR 2.88; 95% CI: 1.28-6.45).
CONCLUSIONS
Excess body weight and concomitant increased waist circumference, but not H. pylori treatment, predicts new-onset esophagitis.",2020,"The 12-month follow-up endoscopic esophagitis rates for the antibiotic and control groups were 10.9% (22/201) and 9.4% (19/203), respectively (p = 0.60).","['Four hundred and four patients were included (mean age, 46.1 years; 78.7% women', 'pylori positive patients with functional dyspepsia who had no baseline reflux symptoms or esophagitis']","['omeprazole, amoxicillin, and clarithromycin (antibiotic group; n\u2009=\u2009201) or omeprazole plus placebo']","['waist circumference', 'association of BMI and other anthropometric measurements', 'Upper gastrointestinal endoscopy and anthropometric assessments', 'baseline waist circumference', 'new-onset esophagitis', 'endoscopic esophagitis rates', 'Baseline anthropometric measurements', 'incidence of esophagitis']","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia (disorder)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",404.0,0.131712,"The 12-month follow-up endoscopic esophagitis rates for the antibiotic and control groups were 10.9% (22/201) and 9.4% (19/203), respectively (p = 0.60).","[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Mazzoleni', 'Affiliation': 'Graduate Program Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. fimazzoleni@hotmail.com.'}, {'ForeName': 'Luiz Edmundo', 'Initials': 'LE', 'LastName': 'Mazzoleni', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Carlos Fernando', 'Initials': 'CF', 'LastName': 'de Magalhães Francesconi', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Guilherme Becker', 'Initials': 'GB', 'LastName': 'Sander', 'Affiliation': 'Graduate Program Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Pâmela Schitz', 'Initials': 'PS', 'LastName': 'Von Reisswitz', 'Affiliation': 'Graduate Program Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Tobias Cancian', 'Initials': 'TC', 'LastName': 'Milbradt', 'Affiliation': 'Clinical Research Unit, Hospital Ernesto Dornelles, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'da Veiga Chaves Picon', 'Affiliation': 'School of Medicine, Universidade do Vale do Taquari, Lajeado, Brazil.'}, {'ForeName': 'Diego Mendonça', 'Initials': 'DM', 'LastName': 'Uchoa', 'Affiliation': 'Department of Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Laura Renata', 'Initials': 'LR', 'LastName': 'De Bona', 'Affiliation': 'Graduate Program Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Huander Felipe', 'Initials': 'HF', 'LastName': 'Andreolla', 'Affiliation': 'Universidade Franciscana, Santa Maria, Brazil.'}, {'ForeName': 'Helenice Pankowski', 'Initials': 'HP', 'LastName': 'Breyer', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Ronaldo', 'Initials': 'R', 'LastName': 'Spinato Torresini', 'Affiliation': 'Graduate Program Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo André', 'Initials': 'EA', 'LastName': 'Ott', 'Affiliation': 'Department of Endoscopy, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'André Castagna', 'Initials': 'AC', 'LastName': 'Wortmann', 'Affiliation': 'Department of Endoscopy, Hospital Nossa Senhora da Conceição, Porto Alegre, Brazil.'}, {'ForeName': 'Alexandro', 'Initials': 'A', 'LastName': 'de Lucena Theil', 'Affiliation': 'Graduate Program Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Jonathas', 'Initials': 'J', 'LastName': 'Stifft', 'Affiliation': 'Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'Raquel Petrucci', 'Initials': 'RP', 'LastName': 'Zenker', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Candice Franke', 'Initials': 'CF', 'LastName': 'Krumel', 'Affiliation': 'Department of Biology and Pharmacy, Universidade de Santa Cruz do Sul, Santa Cruz do Sul, Brazil.'}, {'ForeName': 'Matheus Truccolo', 'Initials': 'MT', 'LastName': 'Michalczuk', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'De Araujo', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Ane Paula', 'Initials': 'AP', 'LastName': 'Canevese', 'Affiliation': 'School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Volpato', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Cristiano André', 'Initials': 'CA', 'LastName': 'da Silva', 'Affiliation': 'Department of Gastroenterology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Pedro Guilherme', 'Initials': 'PG', 'LastName': 'Schaefer', 'Affiliation': 'Department of Pathology, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Natacha Fleck', 'Initials': 'NF', 'LastName': 'Titton', 'Affiliation': 'Clinical Research Center, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Larisse', 'Initials': 'L', 'LastName': 'Longo', 'Affiliation': 'Graduate Program Sciences in Gastroenterology and Hepatology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Edelweiss', 'Affiliation': 'Graduate Program of Medical Science, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Simon', 'Affiliation': 'Human Molecular Genetics Laboratory, Universidade Luterana do Brasil, Canoas, Brazil.'}, {'ForeName': 'Nicholas Joseph', 'Initials': 'NJ', 'LastName': 'Talley', 'Affiliation': 'Faculty of Health and Medicine, University of Newcastle, Newcastle, Australia.'}]",International journal of obesity (2005),['10.1038/s41366-019-0391-3']
3236,31416797,Sleep restriction and testosterone concentrations in young healthy males: randomized controlled studies of acute and chronic short sleep.,"OBJECTIVE
Low testosterone in men increases the risk for various disorders. Severe sleep restriction (SR) may reduce testosterone, but the effects of long-term short sleep are unknown. This study tested the effects of SR on circulating testosterone in healthy young men.
DESIGN
Randomized controlled studies of SR vs habitual sleep (HS) in inpatient (study 1, n=14) and outpatient (study 2, n=13) settings.
METHODS
Study 1 involved severe, acute SR (4 hours time in bed [TIB]) vs HS (9 hours TIB) for 5 nights; study 2 consisted of mild, long-term SR (HS 1.5 hours of sleep/night) vs HS for 6 weeks. Plasma testosterone levels were measured at baseline and end point (study 1) or baseline, week 3, and week 6 (study 2) of each phase. Linear model analyses to assess the effects of SR on testosterone were performed separately for each study.
RESULTS
Study 1: There were no significant sleep-time interaction on testosterone concentrations (change in testosterone levels during HS = 22.86 ± 163.79 ng/dL; SR = 43.73 ± 159.96 ng/dL, P = .41) and no main effect of sleep duration (P = .13). Study 2: There were a trend for a sleep-time interaction (P = .067) and a main effect of sleep on testosterone concentrations from 6 weeks of SR (P = .0046). Testosterone concentrations were slightly lower but increased over time with SR relative to HS.
CONCLUSIONS
Sleep restriction does not adversely affect plasma testosterone levels in healthy young men. Given prior contradicting evidence, confirmatory studies should be done to ascertain the influence of sleep duration and quality on testosterone concentrations in men throughout life.",2019,There were a trend for a sleep-time interaction (P = .067) and a main effect of sleep on testosterone concentrations from 6 weeks of SR (P = .0046).,"['inpatient (study 1, n=14) and outpatient (study 2, n=13) settings', 'young healthy males', 'Study 1 involved severe, acute SR (4 hours time in bed [TIB]) vs HS (9 hours TIB) for 5 nights; study 2 consisted of mild, long-term SR (HS 1.5 hours of sleep/night) vs HS for 6 weeks', 'healthy young men']","['SR', 'SR vs habitual sleep (HS']","['sleep duration', 'testosterone concentrations', 'Testosterone concentrations', 'Sleep restriction and testosterone concentrations', 'Severe sleep restriction (SR', 'sleep duration and quality on testosterone concentrations', 'sleep-time interaction on testosterone concentrations', 'Plasma testosterone levels', 'plasma testosterone levels', 'sleep-time interaction']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1276039', 'cui_str': 'Plasma testosterone measurement'}]",,0.0920563,There were a trend for a sleep-time interaction (P = .067) and a main effect of sleep on testosterone concentrations from 6 weeks of SR (P = .0046).,"[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Institute of Human Nutrition, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Ismel', 'Initials': 'I', 'LastName': 'Salazar', 'Affiliation': 'Sleep center of excellence and Division of Endocrinology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY.'}, {'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'RoyChoudhury', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'St-Onge', 'Affiliation': 'Institute of Human Nutrition, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY; Sleep center of excellence and Division of Endocrinology, Department of Medicine, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY. Electronic address: ms2554@cumc.columbia.edu.'}]",Sleep health,['10.1016/j.sleh.2019.07.003']
3237,31300705,Impact of infant protein supply and other early life factors on plasma metabolome at 5.5 and 8 years of age: a randomized trial.,"OBJECTIVES
A high dairy protein intake in infancy, maternal pre-pregnancy BMI, and delivery mode are documented early programming factors that modulate the later risk of obesity and other health outcomes, but the mechanisms of action are not understood.
METHODS
The Childhood Obesity Project is a European multicenter, double-blind, randomized clinical trial that enrolled healthy infants. Participating infants were either breastfed (BF) or randomized to receive higher (HP) or lower protein (LP) content formula in the first year of life. At the ages 5.5 years (n = 276) and 8 years (n = 232), we determined plasma metabolites by liquid chromatography tandem-mass-spectrometry of which 226 and 185 passed quality control at 5.5 years and 8 years, respectively. We assessed the effects of infant feeding, maternal pre-pregnancy BMI, smoking in pregnancy, delivery mode, parity, birth weight and length, and weight gain (0-24 months) on the metabolome at 5.5 and 8 years.
RESULTS
At 5.5 years, plasma alpha-ketoglutarate and the acylcarnitine/BCAA ratios tended to be higher in the HP than in the LP group, but no metabolite reached statistical significance (P bonferroni >0.09). There were no group differences at 8 years. Quantification of the impact of early programming factors revealed that the intervention group explained 0.6% of metabolome variance at both time points. Except for country of residence that explained 16% and 12% at 5.5 years and 8 years, respectively, none of the other factors explained considerably more variance than expected by chance.
CONCLUSIONS
Plasma metabolome was largely unaffected by feeding choice and other early programming factors and we could not prove the existence of a long term programming effect of the plasma metabolome.",2020,There were no group differences at 8 years.,"['enrolled healthy infants', 'plasma metabolome at 5.5 and 8 years of age', 'Participating infants were either breastfed (BF) or randomized to', 'At the ages 5.5 years (n\u2009=\u2009276) and 8 years (n\u2009=\u2009232), we determined plasma metabolites by liquid chromatography tandem-mass-spectrometry of which 226 and 185 passed quality control at 5.5 years and 8 years, respectively']",['receive higher (HP) or lower protein (LP) content formula'],"['infant feeding, maternal pre-pregnancy BMI, smoking in pregnancy, delivery mode, parity, birth weight and length, and weight gain', 'plasma alpha-ketoglutarate and the acylcarnitine/BCAA ratios']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0008565', 'cui_str': 'Liquid Chromatography'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0034378'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1291208', 'cui_str': 'alpha-Oxoglutarate'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0427642,There were no group differences at 8 years.,"[{'ForeName': 'Franca Fabiana', 'Initials': 'FF', 'LastName': 'Kirchberg', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, Ludwig-Maximilians-Universität München, Lindwurmstr. 4, 80337, Munich, Germany.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hellmuth', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, Ludwig-Maximilians-Universität München, Lindwurmstr. 4, 80337, Munich, Germany.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Totzauer', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, Ludwig-Maximilians-Universität München, Lindwurmstr. 4, 80337, Munich, Germany.""}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Uhl', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, Ludwig-Maximilians-Universität München, Lindwurmstr. 4, 80337, Munich, Germany.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Closa-Monasterolo', 'Affiliation': 'Pediatric, Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV; C/ Dr. Mallafrè Guasch, 4, 43005, Tarragona Reus, Spain.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Escribano', 'Affiliation': 'Pediatric, Nutrition and Human Development Research Unit, Universitat Rovira i Virgili, IISPV; C/ Dr. Mallafrè Guasch, 4, 43005, Tarragona Reus, Spain.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Gruszfeld', 'Affiliation': ""Neonatal Department, Children's Memorial Health Institute, aleja Dzieci Polskich 20; 04-730 Warszawa, Polen, Warszawa, Poland.""}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Gradowska', 'Affiliation': ""Neonatal Department, Children's Memorial Health Institute, aleja Dzieci Polskich 20; 04-730 Warszawa, Polen, Warszawa, Poland.""}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Verduci', 'Affiliation': 'Department of Paediatrics, San Paolo Hospital, University of Milan, Via Antonio di Rudinì, 8, 20142, Milano, MI, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Mariani', 'Affiliation': 'Department of Paediatrics, San Paolo Hospital, University of Milan, Via Antonio di Rudinì, 8, 20142, Milano, MI, Italy.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Moretti', 'Affiliation': 'CHC Sant Vincent, Rue François-Lefèbvre 207, 4000, Liège, Belgium.'}, {'ForeName': 'Déborah', 'Initials': 'D', 'LastName': 'Rousseaux', 'Affiliation': 'CHC Sant Vincent, Rue François-Lefèbvre 207, 4000, Liège, Belgium.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Koletzko', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, Dr. von Hauner Children's Hospital, Ludwig-Maximilians-Universität München, Lindwurmstr. 4, 80337, Munich, Germany. office.koletzko@med.lmu.de.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of obesity (2005),['10.1038/s41366-019-0398-9']
3238,31764266,Applying the Exploration Preparation Implementation Sustainment (EPIS) Framework to the Kigali Imbereheza Project for Rwandan Adolescents Living With HIV.,"BACKGROUND
Sub-Saharan African adolescents living with HIV face challenges to antiretroviral therapy (ART) adherence. Poor mental health drives nonadherence but can be improved with cognitive behavioral therapy (CBT). CBT delivered by peers may strengthen effects while building capacity for sustainment in low-income countries. This case study retrospectively applied the Exploration Preparation Implementation Sustainment framework to characterize the execution of the Kigali Imbereheza Project, a 2-arm individually randomized group controlled trial of Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
METHODS
YL (n = 14, 43% female, M = 22.71 years) had confirmed HIV and self-reported ART adherence >95%. Participants (n = 356, 51% female, M = 16.78 years) living with HIV were randomized to TI-CBTe or usual care. Two YLs co-led TI-CBTe sessions over 2 months for a total of 12 hours, while other YL observed and rated fidelity. Participants reported on YL competence. Additional data evaluated feasibility, acceptability, uptake, and fidelity.
RESULTS
In the Exploration phase, focus groups, stakeholder meetings, and individual interviews revealed strong consensus for delivering TI-CBT to reduce adolescent depression and trauma and improve ART adherence. In the Preparation phase, curriculum revisions were made, YLs were successfully trained, and a cascading supervision model was established. In the Implementation phase, YL delivered TI-CBTe with close monitoring and supervision. Findings revealed strong feasibility, acceptability, uptake, and fidelity, increasing the likelihood of Sustainment.
CONCLUSIONS
Exploration Preparation Implementation Sustainment can guide implementation planning and delivery and evaluate implementation outcomes.",2019,"Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
","['YL (n = 14, 43% female, M = 22.71 years) had confirmed HIV and self-reported ART adherence >95', 'Participants (n = 356, 51% female, M = 16.78 years) living with HIV', 'Rwandan Adolescents Living With HIV', 'adolescents living with HIV']","['cognitive behavioral therapy (CBT', 'Trauma-Informed Adherence-Enhanced CBT (TI-CBTe', 'TI-CBTe or usual care', 'CBT']","['adolescent depression and trauma and improve ART adherence', 'YL competence', 'feasibility, acceptability, uptake, and fidelity', 'strong feasibility, acceptability, uptake, and fidelity, increasing the likelihood of Sustainment']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",,0.0563725,"Trauma-Informed Adherence-Enhanced CBT (TI-CBTe) delivered by Rwandan youth leaders (YLs) to adolescents living with HIV.
","[{'ForeName': 'Geri R', 'Initials': 'GR', 'LastName': 'Donenberg', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Mardge H', 'Initials': 'MH', 'LastName': 'Cohen', 'Affiliation': ""Women's Equity in Access to Care and Treatment (WE-ACTx), San Francisco, CA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Ingabire', 'Affiliation': 'WE-ACTx for Hope Clinic (WFH) Kigali, Rwanda.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Fabri', 'Affiliation': ""Women's Equity in Access to Care and Treatment (WE-ACTx), San Francisco, CA.""}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Emerson', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Ashley D', 'Initials': 'AD', 'LastName': 'Kendall', 'Affiliation': 'Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Remera', 'Affiliation': 'Institute for HIV Disease Prevention and Control, Rwandan Biomedical Center, Kigali, Rwanda.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Manzi', 'Affiliation': 'Department of Medicine, University Teaching Hospital of Kigali (CHUK), Kigali, Rwanda.'}, {'ForeName': 'Sabin', 'Initials': 'S', 'LastName': 'Nsanzimana', 'Affiliation': 'Institute for HIV Disease Prevention and Control, Rwandan Biomedical Center, Kigali, Rwanda.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002204']
3239,31512923,Mediators of physical activity between standard exercise and exercise video games.,"OBJECTIVE
Exercise video games (EVGs) may offer an attractive, sustainable alternative or supplement to traditional modes of exercise. Understanding the psychosocial factors that influence the appeal of EVGs is important for improving the efficacy of video games as a method of promoting the uptake and long-term maintenance of physical activity.
METHODS
This study examined changes in psychosocial constructs from self-determination theory and self-efficacy theory as mediators of intervention efficacy among 189 healthy, sedentary adults randomized to 12-week programs of either EVGs or standard exercise (e.g., treadmill walking, stationary cycling) followed by 6 months of follow-up. The EVG group engaged in significantly more weekly minutes of moderate to vigorous physical activity (MVPA) at the end of treatment compared with the standard exercise group. Univariate and multivariate mediational models were used to examine theoretically derived psychosocial constructs as potential mediators of differential intervention effects.
RESULTS
Univariate mediational models suggest a significant indirect effect of treatment on MVPA outcomes through enjoyment, self-efficacy, stress management, depressive symptoms, and positive engagement ( p < .05). Multiple mediational analyses confirm all the univariate results ( p < .05), with the exception of enjoyment.
CONCLUSIONS
Differences in the efficacy of EVG versus standard exercise interventions were mediated by several psychosocial constructs, suggesting that qualities specific to game play may enhance adherence to physical activity both in and outside of the laboratory environment. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"RESULTS
Univariate mediational models suggest a significant indirect effect of treatment on MVPA outcomes through enjoyment, self-efficacy, stress management, depressive symptoms, and positive engagement ( p < .05).","['189 healthy, sedentary adults']","['EVGs or standard exercise (e.g., treadmill walking, stationary cycling', 'standard exercise and exercise video games', 'Exercise video games (EVGs', 'EVG']","['vigorous physical activity (MVPA', 'MVPA outcomes through enjoyment, self-efficacy, stress management, depressive symptoms, and positive engagement']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439835', 'cui_str': 'Stationary (qualifier value)'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",189.0,0.0216314,"RESULTS
Univariate mediational models suggest a significant indirect effect of treatment on MVPA outcomes through enjoyment, self-efficacy, stress management, depressive symptoms, and positive engagement ( p < .05).","[{'ForeName': 'Beth C', 'Initials': 'BC', 'LastName': 'Bock', 'Affiliation': 'Centers for Behavioral and Preventive Medicine.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Centers for Behavioral and Preventive Medicine.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Ciccolo', 'Affiliation': 'Department of Applied Physiology.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Serber', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences.'}, {'ForeName': 'Wen-Chih', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Sillice', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Psychiatry and Human Behavior.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000791']
3240,31999503,Cardiovascular Acute Effects of Traditional vs. Paired Set Resistance Training in Patients With Liver Cirrhosis.,"Purpose : This study compared the acute effects of two different resistance training methods on heart rate variability, blood pressure, and rating of perceived exertion in patients with liver cirrhosis. Methods : Ten patients with Child-Pugh A (seven women and three men) participated in two experimental sessions, in random order: The traditional set condition consisted of three sets of six exercises performed in a sequential manner, while the paired set condition consisted of alternating sets between two exercises (three pairs of exercises). Ten repetitions were performed for each set with 70% of a 10 repetition maximum load and with 2 min rest between sets. Blood pressure and heart rate variability were assessed pre-workout and for 60 min post-workout. The rating of perceived exertion was assessed at the end of the third set for each exercise. Results : Significant alterations in heart rate variability were observed when considering the lowest value obtained during recovery, in which the SDNN was reduced in both the traditional set and paired set conditions, as well as the root mean square of standard deviation for the traditional set condition ( p < .05). Additionally, for the paired set condition, there was a significant reduction in the HFnu band and a significant increase in the LFnu band ( p < .05). Effect size showed reductions in diastolic and mean blood pressure until 30 min in a small magnitude for traditional sets. Conclusion : Similar cardiovascular responses were observed between methods eliciting normal physiological responses within safe limits for patients with liver cirrhosis.",2020,Effect size showed reductions in diastolic and mean blood pressure until 30 min in a small magnitude for traditional sets. ,"['Ten patients with Child-Pugh A (seven women and three men) participated in two experimental sessions, in random order', 'patients with liver cirrhosis', 'Patients with Liver Cirrhosis']","['resistance training methods', 'Paired Set Resistance Training', 'Traditional Vs']","['cardiovascular responses', 'heart rate variability, blood pressure, and rating of perceived exertion', 'diastolic and mean blood pressure', 'Blood pressure and heart rate variability', 'rating of perceived exertion', 'heart rate variability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",10.0,0.0401689,Effect size showed reductions in diastolic and mean blood pressure until 30 min in a small magnitude for traditional sets. ,"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nasser', 'Affiliation': 'Federal University of Rio de Janeiro.'}, {'ForeName': 'Renata de Mello', 'Initials': 'RM', 'LastName': 'Perez', 'Affiliation': 'Federal University of Rio de Janeiro.'}, {'ForeName': 'Michel Silva', 'Initials': 'MS', 'LastName': 'Reis', 'Affiliation': 'Federal University of Rio de Janeiro.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Dias', 'Affiliation': 'Federal University of Rio de Janeiro.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Willardson', 'Affiliation': 'Montana State University Billings.'}, {'ForeName': 'Humberto', 'Initials': 'H', 'LastName': 'Miranda', 'Affiliation': 'Federal University of Rio de Janeiro.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1696013']
3241,31999478,Pharmacokinetics of Faster and Standard Insulin Aspart During Fully Closed-Loop Insulin Delivery in Type 2 Diabetes.,"Background: Faster insulin aspart is a novel formulation of insulin aspart aiming to accelerate its subcutaneous absorption. The aim of this study was to compare pharmacokinetics of faster insulin aspart versus standard insulin aspart in adults with type 2 diabetes during closed-loop insulin delivery. Methods: We assessed the pharmacokinetics of faster and standard insulin aspart from data obtained in a randomized double-blind crossover study evaluating fully closed-loop insulin delivery in adults with type 2 diabetes ( n = 13, age 59 ± 10 years, BMI 34.5 ± 9.1 kg/m 2 , HbA1c 7.7% ± 1.2% [60 ± 13 mmol/mol]). Blood samples were collected every 15-30 min for 10 h to determine plasma insulin aspart concentration using liquid chromatography mass spectrometry. Time to peak plasma concentration ( T max ) was calculated using a two-compartment model. Results: T max was 68.7 ± 21.6 min for faster aspart and 89.7 ± 31.8 min for aspart (mean paired difference faster aspart minus aspart -15.5 min, 95% CI [-31.6 to 0.6 min], P = 0.06). Metabolic clearance rate did not differ between the two insulins ( P = 0.61). Insulin amount delivered during closed-loop with faster aspart positively correlated with T max ( r S = 0.73, P = 0.01), whereas no statistically significant correlation was found with body mass index (BMI), weight or HbA1C (all P > 0.18). Conclusion: In conclusion, T max tended to be shorter for faster aspart versus aspart during fully automated closed-loop insulin delivery and positively correlated with the amount of insulin delivered.",2020,"Insulin amount delivered during closed-loop with FA positively correlated with Tmax (rS=0.73, p=0.01), whereas no statistically significant correlation was found with BMI, weight or HbA1C (all p>0.18).","['adults with type 2 diabetes (n=13, age 59±10yrs, BMI 34.5±9.1kg/m2, HbA1c 7.7±1.2% [60±13mmol/mol', 'adults with type 2 diabetes during closed-loop insulin delivery', 'type 2 diabetes']","['insulin aspart versus standard insulin aspart', ' Faster insulin aspart', 'faster and standard insulin aspart']","['pharmacokinetics of faster (FA) and standard insulin aspart (A', 'Tmax', 'Metabolic clearance rate', 'BMI, weight or HbA1C', 'Time to peak plasma concentration (Tmax']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0025515', 'cui_str': 'Metabolic Clearance Rate'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0799488,"Insulin amount delivered during closed-loop with FA positively correlated with Tmax (rS=0.73, p=0.01), whereas no statistically significant correlation was found with BMI, weight or HbA1C (all p>0.18).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Dehais', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Prost', 'Affiliation': 'University Institute of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christos T', 'Initials': 'CT', 'LastName': 'Nakas', 'Affiliation': 'University Institute of Clinical Chemistry, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hovorka', 'Affiliation': 'Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0477']
3242,31831094,Association of infant and young child feeding practices with cognitive development at 10-12 years: a birth cohort in rural Western China.,"We aimed to comprehensively examine the association of breast-feeding, types and initial timing of complementary foods with adolescent cognitive development in low- and middle-income countries. We conducted a prospective cohort study of 745 adolescents aged 10-12 years who were born to women who participated in a randomised trial of prenatal micronutrient supplementation in rural Western China. An infant feeding index was constructed based on the current WHO recommendations. Full-scale intelligence quotient (FSIQ) was assessed and derived by the fourth edition of the Wechsler Intelligence Scale for Children. The duration of exclusive or any breast-feeding was not significantly associated with adolescent cognitive development. Participants who regularly consumed Fe-rich or Fe-fortified foods during 6-23 months of age had higher FSIQ than those who did not (adjusted mean differences 4·25; 95 % CI 1·99, 6·51). For cows'/goats' milk and high protein-based food, the highest FSIQ was found in participants who initially consumed at 10-12 and 7-9 months, respectively. A strong dose-response relationship of the composite infant feeding index was also identified, with participants in the highest tertile of overall feeding quality having 3·03 (95 % CI 1·37, 4·70) points higher FSIQ than those in the lowest tertile. These findings suggest that appropriate infant feeding practices (breast-feeding plus timely introduction of appropriate complementary foods) were associated with significantly improved early adolescent cognitive development scores in rural China. In addition, improvement in Fe-rich or Fe-fortified foods complementary feeding may produce better adolescent cognitive development outcomes.",2020,The duration of exclusive or any breast-feeding was not significantly associated with adolescent cognitive development.,"['in rural Western China', '745 adolescents aged 10-12 years who were born to women who participated in a randomised trial of', 'infant and young child feeding practices with cognitive development at 10-12 years: a birth cohort in rural Western China', 'low- and middle-income countries']",['prenatal micronutrient supplementation'],"['duration of exclusive or any breast-feeding', 'Full-scale intelligence quotient (FSIQ', 'early adolescent cognitive development scores']","[{'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0006147', 'cui_str': 'Breastfeeding'}, {'cui': 'C0222045'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient (observable entity)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",745.0,0.0368031,The duration of exclusive or any breast-feeding was not significantly associated with adolescent cognitive development.,"[{'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Nutrition and Food Safety Research, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Qi', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Siyuan', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Shaoru', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elhoumed', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Sintayehu', 'Initials': 'S', 'LastName': 'Tsegaye', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'Sydney School of Public Health, University of Sydney, Camperdown, NSW 2006, Australia.'}, {'ForeName': 'Lingxia', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi'an, Shaanxi 710061, People's Republic of China.""}]",The British journal of nutrition,['10.1017/S0007114519003271']
3243,31556659,Associations between self-monitoring and weight change in behavioral weight loss interventions.,"OBJECTIVE
The current study is a secondary analysis of the Live SMART trial, a randomized controlled trial comparing a behavioral weight loss (BWL) condition delivered via smartphone (SMART) to a group-based BWL condition (GROUP) and a control condition (CONTROL). Given the established importance of self-monitoring for weight loss, the aims were to evaluate bidirectional associations between adherence to self-monitoring and weight change and to examine the moderating effect of treatment condition on these associations.
METHOD
Adults with overweight/obesity (n = 276; 83% women; 92.8% White; Mage = 55.1 years; Mbody mass index = 35.2 kg/m2) were instructed to self-monitor dietary intake, daily weight, and physical activity minutes via paper diaries in GROUP and CONTROL and via a smartphone application in SMART. All participants were weighed monthly at the research center. Adherence to self-monitoring was assessed via examination of self-monitoring records.
RESULTS
Generalized linear mixed models revealed that adherence to self-monitoring of dietary intake, self-weighing, and physical activity for each month was associated with weight change throughout that month, such that increased frequency of self-monitoring led to greater weight loss (ps < .001). For the GROUP condition only, poorer weight losses in 1 month were prospectively associated with poor adherence to self-monitoring the following month (ps ≤ .01).
CONCLUSIONS
Results provide evidence of a bidirectional association between self-monitoring and weight change. Better self-monitoring was consistently associated with better weight loss across intervention and tracking modalities. Poorer weight loss was prospectively associated with poorer self-monitoring in group treatment, suggesting that social influences could drive adherence in this form of treatment. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"For the GROUP condition only, poorer weight losses in 1 month were prospectively associated with poor adherence to self-monitoring the following month (ps ≤ .01).
",['Adults with overweight/obesity (n = 276; 83% women; 92.8% White; Mage = 55.1 years; Mbody mass index = 35.2 kg/m2'],"['self-monitor dietary intake, daily weight, and physical activity minutes via paper diaries in GROUP and CONTROL and via a smartphone application in SMART', 'behavioral weight loss (BWL) condition delivered via smartphone (SMART']","['poorer weight losses', 'Poorer weight loss', 'weight loss', 'adherence to self-monitoring of dietary intake, self-weighing, and physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",2019.0,0.0193581,"For the GROUP condition only, poorer weight losses in 1 month were prospectively associated with poor adherence to self-monitoring the following month (ps ≤ .01).
","[{'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Goldstein', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Bond', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Raynor', 'Affiliation': 'Department of Nutrition, University of Tennessee, Knoxville.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000800']
3244,32001832,Predictive factors of 5-year relapse-free survival in HR+/HER2- breast cancer patients treated with neoadjuvant endocrine therapy: pooled analysis of two phase 2 trials.,"BACKGROUND
Few data are available on survival and predictive factors in early breast cancer (BC) patients treated with neoadjuvant endocrine therapy (NET).
METHODS
This is a pooled analysis of two multicentre, randomised non-comparative phase 2 clinical trials evaluating neoadjuvant anastrozole and fulvestrant efficacy for postmenopausal HR+/HER2- breast cancer patients: HORGEN (NCT00871858) and CARMINA02 (NCT00629616) studies.
RESULTS
In total, 236 patients were included in CARMINA02 and HORGEN trials. Modified intention-to-treat analysis was available for 217 patients. Median follow-up was 65.2 months. Relapse-free survival (RFS) and overall survival (OS) at 5 years were 83.7% (95% CI: 77.9-88) and 92.7% (95% CI: 88.2-95.6), respectively, with no difference between treatment arms. On univariate analysis, tumour staging (T2 vs T3-4; p = 0.0001), Ki-67 at surgery (≤10% vs >10%; p = 0.0093), pathological tumour size (pT1-2 vs pT3-4; p = 0.0012) and node status (pN negative vs positive; p = 0.007), adjuvant chemotherapy (p = 0.0167) and PEPI score (PEPI group I + II vs III; p = 0.0004) were associated with RFS. No events were observed in patients with pathological response according to the Sataloff classification. Multivariate analysis showed that preoperative endocrine prognostic index (PEPI) group III was associated with significantly worse RFS (p = 0.0069, hazard ratio = 3.33 (95% CI: 1.39-7.98)).
CONCLUSIONS
Postmenopausal HR+/HER2- breast cancer patients receiving NET generally have a favourable outcome. The PEPI score identifies a subset of patients of poorer prognosis who are candidates for further additional treatment.",2020,"Relapse-free survival (RFS) and overall survival (OS) at 5 years were 83.7% (95% CI: 77.9-88) and 92.7% (95% CI: 88.2-95.6), respectively, with no difference between treatment arms.","['217 patients', 'postmenopausal HR+/HER2- breast cancer patients', 'Postmenopausal HR+/HER2- breast cancer patients receiving', 'HR+/HER2- breast cancer patients treated with', 'early breast cancer (BC) patients treated with', '236 patients were included in CARMINA02 and HORGEN trials']","['neoadjuvant endocrine therapy', 'neoadjuvant anastrozole', 'NET', 'neoadjuvant endocrine therapy (NET']","['RFS', 'PEPI score', 'pathological tumour size', 'Relapse-free survival (RFS) and overall survival (OS', 'preoperative endocrine prognostic index', '5-year relapse-free survival']","[{'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",236.0,0.225608,"Relapse-free survival (RFS) and overall survival (OS) at 5 years were 83.7% (95% CI: 77.9-88) and 92.7% (95% CI: 88.2-95.6), respectively, with no difference between treatment arms.","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Lerebours', 'Affiliation': 'Institut Curie, Saint Cloud, France. florence.lerebours@curie.fr.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pulido', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié, INSERM CIC 14.01, Bordeaux, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Fourme', 'Affiliation': 'Institut Curie, Saint Cloud, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debled', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Becette', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bonnefoi', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Rivera', 'Affiliation': 'Department of Radiation Oncology, Gustave Roussy Cancer Campus, Villejuif, France.'}, {'ForeName': 'Gaetan', 'Initials': 'G', 'LastName': 'MacGrogan', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Marie-Ange', 'Initials': 'MA', 'LastName': 'Mouret-Reynier', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Christine Tunon', 'Initials': 'CT', 'LastName': 'de Lara', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'Breton-Callu', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Venat-Bouvet', 'Affiliation': 'CHU, Limoges, France.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Mathoulin-Pélissier', 'Affiliation': 'Clinical and Epidemiological Research Unit, Institut Bergonié, INSERM CIC 14.01, Bordeaux, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'de la Motte Rouge', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Dalenc', 'Affiliation': 'Institut Claudius Regaud-IUCT Oncopole, Toulouse, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Sigal', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': 'Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Lemonnier', 'Affiliation': 'R&D UNICANCER, UCBG, Paris, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Quenel-Tueux', 'Affiliation': 'Institut Bergonié, Bordeaux, France.'}]",British journal of cancer,['10.1038/s41416-020-0733-x']
3245,31892668,Intermittent theta burst stimulation applied during early rehabilitation after stroke: study protocol for a randomised controlled trial.,"INTRODUCTION
Intermittent theta burst stimulation (iTBS) applied to primary motor cortex (M1) has been shown to modulate both the excitability and connectivity of the motor system. A recent proof-of-principle study, based on a small group of hospitalised patients with acute ischemic stroke, suggested that iTBS applied to the ipsilesional M1 combined with physical therapy early after stroke can amplify motor recovery with lasting after effects. A randomised controlled clinical trial using a double-blind design is warranted to justify the implementation of iTBS-assisted motor rehabilitation in neurorehabilitation from an acute ischaemic stroke.
METHODS/DESIGN
We investigate the effects of daily iTBS on early motor rehabilitation after stroke in an investigator-initiated, longitudinal randomised controlled trial. Patients (n=150) with hemiparesis receive either iTBS (600 pulses) applied to the ipsilesional motor cortex (M1) or a control stimulation (ie, coil placement over the parieto-occipital vertex in parallel to the interhemispheric fissure and with a tilt of 45°). On 8 consecutive workdays, a 45 min arm-centred motor training follows the intervention . The relative grip strength, defined as the grip force ratios of the affected and unaffected hands, serves as the primary outcome parameter. Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1.
ETHICS AND DISSEMINATION
The study was approved by the Ethics Commission of the Medical Faculty, University of Cologne, Germany (reference number 15-343). Data will be disseminated through peer-reviewed publications and presentations at conferences. Study title: Theta-Burst Stimulation in Early Rehabilitation after Stroke (acronym: TheSiReS). Study registration at German Registry for Clinical Trials (DRKS00008963) and at ClinicalTrials.gov (NCT02910024).",2019,"Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1.
","['hospitalised patients with acute ischemic stroke', 'Patients (n=150) with hemiparesis receive either']","['iTBS-assisted motor rehabilitation', 'daily iTBS', 'Intermittent theta burst stimulation (iTBS', 'iTBS (600 pulses) applied to the ipsilesional motor cortex (M1) or a control stimulation (ie, coil placement over the parieto-occipital vertex in parallel to the interhemispheric fissure and with a tilt of 45°', 'Intermittent theta burst stimulation']","['measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1', 'relative grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026607', 'cui_str': 'Somatomotor Areas'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0228186', 'cui_str': 'Structure of longitudinal cerebral fissure'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0222045'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}]",600.0,0.112785,"Secondary outcome parameters are measures of arm function (Action Research Arm Test, Fugl-Meyer Motor Scale), stroke severity (National Institutes of Health Stroke Scale), stroke-induced disability (modified Rankin Scale, Barthel Index), duration of inpatient rehabilitation, quality of life (EuroQol 5D), motor evoked potentials and the resting motor threshold of the ipsilesional M1.
","[{'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hensel', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grefkes', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Tscherpel', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Ringmaier', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Kraus', 'Affiliation': 'Clinical Trials Center Cologne, University of Cologne, Cologne, Germany, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Lukas J', 'Initials': 'LJ', 'LastName': 'Volz', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany g.r.fink@fz-juelich.de.'}]",BMJ open,['10.1136/bmjopen-2019-034088']
3246,31992234,Intensive psychotherapy and case management for Karen refugees with major depression in primary care: a pragmatic randomized control trial.,"BACKGROUND
Despite an unparalleled global refugee crisis, there are almost no studies in primary care addressing real-world conditions and longer courses of treatment that are typical when resettled refugees present to their physician with critical psychosocial needs and complex symptoms. We studied the effects of a year of psychotherapy and case management in a primary care setting on common symptoms and functioning for Karen refugees (a newly arrived population in St Paul, Minnesota) with depression.
METHODS
A pragmatic parallel-group randomized control trial was conducted at two primary care clinics with large resettled Karen refugee patient populations, with simple random allocation to 1 year of either: (1) intensive psychotherapy and case management (IPCM), or (2) care-as-usual (CAU). Eligibility criteria included Major Depression diagnosis determined by structured diagnostic clinical interview, Karen refugee, ages 18-65. IPCM (n = 112) received a year of psychotherapy and case management coordinated onsite between the case manager, psychotherapist, and primary care providers; CAU (n = 102) received care-as-usual from their primary care clinic, including behavioral health referrals and/or brief onsite interventions. Blinded assessors collected outcomes of mean changes in depression and anxiety symptoms (measured by Hopkins Symptom Checklist-25), PTSD symptoms (Posttraumatic Diagnostic Scale), pain (internally developed 5-item Pain Scale), and social functioning (internally developed 37-item instrument standardized on refugees) at baseline, 3, 6 and 12 months. After propensity score matching, data were analyzed with the intention-to-treat principle using repeated measures ANOVA with partial eta-squared estimates of effect size.
RESULTS
Of 214 participants, 193 completed a baseline and follow up assessment (90.2%). IPCM patients showed significant improvements in depression, PTSD, anxiety, and pain symptoms and in social functioning at all time points, with magnitude of improvement increasing over time. CAU patients did not show significant improvements. The largest mean differences observed between groups were in depression (difference, 5.5, 95% CI, 3.9 to 7.1, P < .001) and basic needs/safety (difference, 5.4, 95% CI, 3.8 to 7.0, P < .001).
CONCLUSIONS
Adult Karen refugees with depression benefited from intensive psychotherapy and case management coordinated and delivered under usual conditions in primary care. Intervention effects strengthened at each interval, suggesting robust recovery is possible.
TRIAL REGISTRATION
clinicaltrials.gov Identifier: NCT03788408. Registered 20 Dec 2018. Retrospectively registered.",2020,"IPCM patients showed significant improvements in depression, PTSD, anxiety, and pain symptoms and in social functioning at all time points, with magnitude of improvement increasing over time.","['214 participants', 'Karen refugees with major depression in primary care', 'primary care setting on common symptoms and functioning for Karen refugees (a newly arrived population in St Paul, Minnesota) with depression', 'Eligibility criteria included Major Depression diagnosis determined by structured diagnostic clinical interview, Karen refugee, ages 18-65', 'two primary care clinics with large resettled Karen refugee patient populations, with simple random allocation to 1 year of either: (1) intensive psychotherapy and case management (IPCM), or (2) care-as-usual (CAU']","['psychotherapy and case management coordinated onsite between the case manager, psychotherapist, and primary care providers; CAU (n\u2009=\u2009102) received care-as-usual from their primary care clinic, including behavioral health referrals and/or brief onsite interventions', 'CAU', 'IPCM ', 'Intensive psychotherapy', 'psychotherapy and case management', 'IPCM']","['depression, PTSD, anxiety, and pain symptoms and in social functioning', 'depression and anxiety symptoms (measured by Hopkins Symptom Checklist-25), PTSD symptoms (Posttraumatic Diagnostic Scale), pain (internally developed 5-item Pain Scale), and social functioning']","[{'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0444892', 'cui_str': 'CAU'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0557555', 'cui_str': 'Psychotherapists'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0601531', 'cui_str': 'IPCM'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0222045'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}]",,0.280626,"IPCM patients showed significant improvements in depression, PTSD, anxiety, and pain symptoms and in social functioning at all time points, with magnitude of improvement increasing over time.","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Northwood', 'Affiliation': 'Center for Victims of Torture, 2356 University Ave W Ste 430, St Paul, MN, 55114, USA. anorthwood@cvt.org.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Vukovich', 'Affiliation': 'Center for Victims of Torture, 2356 University Ave W Ste 430, St Paul, MN, 55114, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Beckman', 'Affiliation': 'Center for Victims of Torture, 2356 University Ave W Ste 430, St Paul, MN, 55114, USA.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Walter', 'Affiliation': 'University of Minnesota, Boyton Health Mental Health Clinic, 410 Church St SE, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Novia', 'Initials': 'N', 'LastName': 'Josiah', 'Affiliation': 'Center for Victims of Torture, 2356 University Ave W Ste 430, St Paul, MN, 55114, USA.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Hudak', 'Affiliation': 'Live-Oak, 1300 W Belmont Ave #300, Chicago, IL, 60657, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': ""O'Donnell Burrows"", 'Affiliation': 'Center for Victims of Torture, 2356 University Ave W Ste 430, St Paul, MN, 55114, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Letts', 'Affiliation': 'HealthEast Roselawn Clinic, 1983 Sloan Pl #1, St Paul, MN, 55117, USA.'}, {'ForeName': 'Christine C', 'Initials': 'CC', 'LastName': 'Danner', 'Affiliation': ""St Joseph's Family Medicine Residency Program, University of Minnesota Physicians, Bethesda Family Medicine Clinic, 580 Rice St, St Paul, MN, 55103, USA.""}]",BMC family practice,['10.1186/s12875-020-1090-9']
3247,31994918,Examining the Relationships between Cumulative Childhood Adversity and the Risk of Criminal Justice Involvement and Victimization among Homeless Adults with Mental Illnesses after Receiving Housing First Intervention.,"OBJECTIVES
Exposure to adverse childhood experiences (ACEs) is associated with increased risk of criminal justice involvement and repeated victimization among homeless individuals. This study aimed to (1) examine whether the relationship between cumulative ACE score and odds of experiencing criminal justice involvement and victimization remains significant over time after receiving the Housing First (HF) intervention and (2) investigate the moderating effect of cumulative ACE score on the effectiveness of the HF intervention on the likelihood of experiencing these outcomes among homeless individuals with mental illnesses.
METHODS
We used longitudinal data over the 2-year follow-up period from the At Home/ Chez Soi demonstration project that provided HF versus treatment as usual (TAU) to homeless adults with mental illness in five Canadian cities (N = 1,888).
RESULTS
In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors. However, cumulative ACE score did not moderate intervention effects on odds of experiencing either outcome, suggesting that the effectiveness of HF versus TAU, with regard to the odds of being victimized or criminal justice involvement, did not differ by cumulative ACE scores over the course of study.
CONCLUSIONS
Findings suggest that providing services for homeless individuals with mental illness should be trauma informed and include specialized treatment strategies targeting the experience of ACEs and trauma to improve their treatment outcomes. An intensive approach is required to directly address the problem of criminal justice involvement and victimization in these individuals.",2020,"In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors.","['homeless adults with mental illness in five Canadian cities (N = 1,888', 'homeless individuals with mental illnesses', 'Homeless Adults with Mental Illnesses after Receiving Housing First Intervention', 'homeless individuals', 'homeless individuals with mental illness']","['HF versus treatment as usual (TAU', 'Housing First (HF) intervention', 'HF intervention']","['cumulative ACE scores', 'cumulative ACE score']","[{'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",1888.0,0.0419138,"In all 4 follow-up time points, the relationship between cumulative ACE score and both outcomes remained significant, regardless of study arm (HF vs. TAU) and other confounding factors.","[{'ForeName': 'Hanie', 'Initials': 'H', 'LastName': 'Edalati', 'Affiliation': 'Department of Psychiatry, University of Montreal, Quebec, Canada.'}, {'ForeName': 'Tonia L', 'Initials': 'TL', 'LastName': 'Nicholls', 'Affiliation': 'British Columbia Mental Health and Substance Use Services, Provincial Health Services Authority, Vancouver, Canada.'}, {'ForeName': 'Christian G', 'Initials': 'CG', 'LastName': 'Schütz', 'Affiliation': 'Department of Psychiatry, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Somers', 'Affiliation': 'Faculty of Health Sciences, Somers Research Group, Simon Fraser University, Burnaby, British Columbia, Canada.'}, {'ForeName': 'Jino', 'Initials': 'J', 'LastName': 'Distasio', 'Affiliation': 'Institute of Urban Studies, University of Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Aubry', 'Affiliation': 'School of Psychology, University of Ottawa, Ontario, Canada.'}, {'ForeName': 'Anne G', 'Initials': 'AG', 'LastName': 'Crocker', 'Affiliation': 'Department of Psychiatry, University of Montreal, Quebec, Canada.'}]",Canadian journal of psychiatry. Revue canadienne de psychiatrie,['10.1177/0706743720902616']
3248,31842688,End-of-Treatment Intracerebral and Ventricular Hemorrhage Volume Predicts Outcome: A Secondary Analysis of MISTIE III.,"Background and Purpose- Trials have shown potential clinical benefit for minimally invasive clot evacuation of intracerebral hemorrhage (ICH). Prior research showing an association between ICH size and functional outcome did not fully address the spectrum of hematoma volumes seen after clot evacuation. Methods- In this secondary analysis of the MISTIE III trial (Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation III), we included patients randomized to the surgical arm. The primary outcome was good outcome (modified Rankin Scale score 0-3 at 1 year from study enrollment). The primary predictors were the end-of-treatment (EoT) ICH and intraventricular hemorrhage volumes and an end-of-treatment ICH stratification scale called the EoT ICH volume score. Results- In 246 patients, the end-of-treatment computed tomography was performed an average of 5 days from onset. For patients with good versus poor outcomes, the mean end-of-treatment ICH and intraventricular hemorrhage volumes were 12.9 versus 18.0 mL ( P =0.002) and 0.5 versus 2.3 mL ( P <0.001), respectively. The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0 (>20 mL; P =0.001). Conclusions- After surgical clot evacuation, both ICH and intraventricular hemorrhage volumes have a strong association with good neurological outcome. The EoT ICH volume score needs independent verification, but such an approach could be used for prognostication and therapeutic planning.",2020,The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0,['Intracerebral Hemorrhage Evacuation III'],"['Methods', ' and Purpose']","['good outcome (modified Rankin Scale score 0-3 at 1 year from study enrollment', 'mean end-of-treatment ICH and intraventricular hemorrhage volumes', 'end-of-treatment (EoT) ICH and intraventricular hemorrhage volumes and an end-of-treatment ICH stratification scale called the EoT ICH volume score']","[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",246.0,0.0819232,The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Joyce', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'the Department of Neurology, New York University (S.Y.).'}, {'ForeName': 'Safdar', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Delic', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Taussky', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Radiology (M.A.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tirschwell', 'Affiliation': 'the Department of Neurology, University of Washington, Seattle (D.T.).'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Grandhi', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}]",Stroke,['10.1161/STROKEAHA.119.028199']
3249,31987512,Effectiveness of the multi-component dynamic work intervention to reduce sitting time in office workers - Results from a pragmatic cluster randomised controlled trial.,"OBJECTIVE
Prolonged sitting, which is highly prevalent in office workers, has been associated with several health risks. The aim of this study was to evaluate the Dynamic Work intervention by determining its effect on total sitting time at the 8-month follow-up in comparison to the control.
METHODS
This two-arm pragmatic cluster randomised controlled trial included 244 office workers from 14 different departments of a large, Dutch insurance company. The Dynamic Work intervention was a real-life, worksite intervention that included environmental components (i.e. sit-stand workstations), organisational components (i.e. group sessions), and individual components (e.g. activity/sitting trackers). Outcomes were assessed at baseline, 4-month follow-up, and 8-month follow-up. The primary outcome was total sitting time per day, objectively assessed using the activPAL activity monitor at 8-month follow-up. Secondary outcomes included other total and occupational movement behaviour outcomes, health-related outcomes, and work-related outcomes. Data analyses were performed using linear and logistic mixed models.
RESULTS
Total sitting time did not differ between the intervention and control group at the 8-month follow-up. Secondary outcomes also showed no difference between the intervention and control group at either the 4-month or at 8-month follow-up, with the exception of number of occupational steps, which showed a statistically significant effect at 4-month follow-up (but not at 8-month follow-up) of 913 (95% CI = 381-1445) steps/8-h working day.
CONCLUSIONS
This study evaluated the effectiveness of a real-life worksite intervention to reduce sitting time and showed little to no effect. This may be due to the relatively low intensity of the intervention, i.e. that it only involved the replacement of 25% of sitting workstations with sit-stand workstations. Future research should focus on the evaluation of more intensive real-life worksite interventions that are still feasible for implementation in daily practice. CLINICALTRIALS.
GOV, REGISTRATION NUMBER
NCT03115645.",2020,"Secondary outcomes also showed no difference between the intervention and control group at either the 4-month or at 8-month follow-up, with the exception of number of occupational steps, which showed a statistically significant effect at 4-month follow-up (but not at 8-month follow-up) of 913 (95% CI = 381-1445) steps/8-h working day.
","['244 office workers from 14 different departments of a large, Dutch insurance company']","['real-life worksite intervention', 'multi-component dynamic work intervention']","['total sitting time', 'Total sitting time', 'sitting time', 'number of occupational steps', 'total and occupational movement behaviour outcomes, health-related outcomes, and work-related outcomes', 'total sitting time per day, objectively assessed using the activPAL activity monitor']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]",244.0,0.0642137,"Secondary outcomes also showed no difference between the intervention and control group at either the 4-month or at 8-month follow-up, with the exception of number of occupational steps, which showed a statistically significant effect at 4-month follow-up (but not at 8-month follow-up) of 913 (95% CI = 381-1445) steps/8-h working day.
","[{'ForeName': 'Lidewij R', 'Initials': 'LR', 'LastName': 'Renaud', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, the Netherlands. Electronic address: l.renaud@amsterdamumc.nl.'}, {'ForeName': 'Judith G M', 'Initials': 'JGM', 'LastName': 'Jelsma', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Maaike A', 'Initials': 'MA', 'LastName': 'Huysmans', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'van Nassau', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Lakerveld', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam UMC, the Netherlands; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands; Global Geo Health Data Center, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Erwin M', 'Initials': 'EM', 'LastName': 'Speklé', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, the Netherlands; Arbo Unie, Occupational Health Service, Utrecht, the Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Dominique P M', 'Initials': 'DPM', 'LastName': 'Stijnman', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Pediatrics, Amsterdam Cardiovascular Sciences Institute, the Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Loyen', 'Affiliation': 'National Institute for Public Health and the Environment, Centre for Nutrition, Prevention and Health Services, Bilthoven, the Netherlands.'}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, the Netherlands.'}, {'ForeName': 'Hidde P', 'Initials': 'HP', 'LastName': 'van der Ploeg', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational Health, Amsterdam Public Health Research Institute, the Netherlands.'}]",Applied ergonomics,['10.1016/j.apergo.2019.103027']
3250,31812702,"Two phase 3, double-blind, placebo-controlled studies of the efficacy and safety of Astodrimer 1% Gel for the treatment of bacterial vaginosis.","OBJECTIVE
Astodrimer is a dendrimer formulated in a vaginal gel to treat bacterial vaginosis (BV) and prevent recurrence. The objective of these studies was to confirm the efficacy and safety of Astodrimer 1 % Gel for treatment of BV.
STUDY DESIGN
Women with bacterial vaginosis were randomized 1:1 to Astodrimer 1 % Gel (Study 1 conducted in the United States, N = 127; Study 2 conducted in the United States, Germany and Belgium, N = 128) or placebo gel (Study 1, N = 123; Study 2, N = 123) at a dose of 5 g vaginally once daily for 7 days. The primary endpoint was clinical cure, defined as i) absence of bacterial vaginosis vaginal discharge; ii) <20 % clue cells; and iii) negative whiff test at day 9-12. Secondary efficacy analyses included clinical cure at day 21-30. Other endpoints at days 9-12 and 21-30 included Nugent cure (Nugent score ≤3), absence of symptoms, and adverse events. The primary analysis in the modified intent-to-treat population used the Cochran Mantel Haenszel test stratified by analysis center with a two-sided significance level of α = .05.
RESULTS
Astodrimer 1 % Gel was superior to placebo for the primary and selected secondary efficacy measures. Clinical cure rates at day 9-12 were 50.4 % (59/117) vs 16.5 % (19/115, P < .001) (Study 1) and 56.7 % (68/120) vs 21.4 % (25/117, P < .001) (Study 2) for astodrimer vs placebo. At day 21-30, clinical cure results showed a similar trend but the difference to placebo was not statistically significant. Nugent cure rates at day 9-12 were 12.8 % (15/117) vs 2.6 % (3/115, P = .004) (Study 1) and 13.3 % (16/120) vs 5.1 % (6/117, P = .030) (Study 2) for astodrimer vs placebo. A greater proportion of women receiving astodrimer reported absence of vaginal discharge and absence of vaginal odor at day 9-12 and day 21-30 compared with placebo. Adverse events were generally mild and self-limiting. For the combined studies, adverse events potentially related to treatment occurred in 14.7 % (37/252) of astodrimer patients vs 9.4 % (23/244) for placebo, including vulvovaginal candidiasis reported for 2.4 % (6/252) of astodrimer patients.
CONCLUSION
These results support a role for Astodrimer 1 % Gel as an effective, safe and well-tolerated treatment for women with bacterial vaginosis.",2020,"Clinical cure rates at day 9-12 were 50.4 % (59/117) vs 16.5 % (19/115, P < .001)","['Women with bacterial vaginosis were randomized 1:1 to Astodrimer 1 % Gel (Study 1 conducted in the United States, N\u202f=\u202f127; Study 2 conducted in the United States, Germany and Belgium, N\u202f=\u202f128) or', 'bacterial vaginosis', 'women with bacterial vaginosis']","['placebo gel', 'placebo', 'Astodrimer 1% Gel', 'astodrimer vs placebo']","['Nugent cure (Nugent score ≤3), absence of symptoms, and adverse events', 'clinical cure', 'Nugent cure rates', 'Clinical cure rates', 'effective, safe and well-tolerated treatment', 'vaginal discharge and absence of vaginal odor', 'Adverse events', 'clinical cure, defined as i) absence of bacterial vaginosis vaginal discharge', 'efficacy and safety', 'vulvovaginal candidiasis']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0227791', 'cui_str': 'Vaginal Discharge'}, {'cui': 'C0235678', 'cui_str': 'Vaginal odor (finding)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0700345', 'cui_str': 'Moniliasis, Vulvovaginal'}]",,0.44003,"Clinical cure rates at day 9-12 were 50.4 % (59/117) vs 16.5 % (19/115, P < .001)","[{'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Chavoustie', 'Affiliation': 'Segal Institute, Miami, FL, USA.'}, {'ForeName': 'Belvia A', 'Initials': 'BA', 'LastName': 'Carter', 'Affiliation': ""Women's Physician Group, Memphis, TN, USA.""}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Waldbaum', 'Affiliation': ""Downtown Women's Health Care, Denver, CO, USA.""}, {'ForeName': 'Gilbert G G', 'Initials': 'GGG', 'LastName': 'Donders', 'Affiliation': 'Femicare Clinical Research for Women, Tienen, Department of Obstetrics and Gynecology, The Regional Hospital Heilig Hart, Tienen, and University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Klaus H', 'Initials': 'KH', 'LastName': 'Peters', 'Affiliation': 'Praxis Dr Peters, Hamburg, Germany.'}, {'ForeName': 'Jane R', 'Initials': 'JR', 'LastName': 'Schwebke', 'Affiliation': 'Division of Infectious Diseases, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Jeremy R A', 'Initials': 'JRA', 'LastName': 'Paull', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia. Electronic address: jeremy.paull@starpharma.com.'}, {'ForeName': 'Clare F', 'Initials': 'CF', 'LastName': 'Price', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Castellarnau', 'Affiliation': 'Starpharma Pty Ltd, Melbourne, VIC, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McCloud', 'Affiliation': 'McCloud Consulting Group, Sydney, NSW, Australia.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Kinghorn', 'Affiliation': 'Royal Hallamshire and Sheffield Teaching Hospitals, Sheffield, United Kingdom.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2019.11.032']
3251,31993664,Compliance in controlled e-cigarette studies.,"INTRODUCTION
E-cigarette studies have found that use of a variety of flavors and customizable devices results in greater use frequency and user satisfaction. However, standardized research e-cigarettes are being developed as closed systems with limited flavor options, potentially limiting user satisfaction. In this study, we explore protocol compliance in an e-cigarette study using a standardized, assigned device with puff time and duration tracking (controlled e-cigarette) and potential limitations that controlled devices and e-liquids can introduce.
METHODS
In a crossover study forty-nine young adult e-cigarette users were recruited using convenience sampling and assigned a controlled e-cigarette device and flavored or unflavored e-liquids on standardized protocols. E-cigarette use frequency (number of puffs per day, collected from the device) and serum cotinine levels were obtained at each of 3 study visits over three weeks. The correlation of cotinine and e-cigarette use over the preceding week was calculated at each study visit.
RESULTS
Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (R2=0.53 and p≤0.01 in week 1, R2<0.5 and p>0.05 for remaining weeks).
CONCLUSIONS
There is an emerging need for controlled e-cigarette exposures studies, but low compliance in use of assigned devices and e-liquids may be a limitation that needs to be mitigated in future studies.",2020,"RESULTS
Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (",['forty-nine young adult e-cigarette users'],['convenience sampling and assigned a controlled e-cigarette device and flavored or unflavored e-liquids on standardized protocols'],"['serum cotinine levels', 'serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",49.0,0.0258947,"RESULTS
Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (","[{'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'Rebuli', 'Affiliation': 'Curriculum in Toxicology & Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Urman', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barrington-Trimis', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Sandrah P', 'Initials': 'SP', 'LastName': 'Eckel', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'McConnell', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Jaspers', 'Affiliation': 'Curriculum in Toxicology & Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa017']
3252,31990615,Treatment for Borderline Personality Disorder and Secondary Effects on Somatization.,"Borderline personality disorder (BPD) is often accompanied by other diagnoses. Some comorbidities have received a good deal of attention, but others, including somatization, have not. As effective treatments for BPD are identified, the secondary effects of these treatments on BPD comorbidities are of clinical relevance. Secondary data were used from a randomized clinical trial of dialectical behavior therapy (DBT) and community treatment by experts among 101 women with BPD in order to characterize change in somatization with treatment for BPD, and to examine emotional avoidance as a mediator. Somatization decreased significantly over time, which did not differ by treatment condition. DBT had an indirect effect on somatization through less emotional avoidance. These results suggest that the comorbid presence of significant somatization should be evaluated among those with BPD, especially in the context of emotional avoidance; treatments could be enhanced by addressing emotion regulation skills.",2020,"Somatization decreased significantly over time, which did not differ by treatment condition.","['Borderline personality disorder (BPD', '101 women with BPD']","['dialectical behavior therapy (DBT', 'DBT']",['Somatization'],"[{'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]",[],101.0,0.0211455,"Somatization decreased significantly over time, which did not differ by treatment condition.","[{'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Schmaling', 'Affiliation': 'Department of Psychology, Washington State University, Vancouver, Washington.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Fales', 'Affiliation': 'Department of Psychology, Washington State University, Vancouver, Washington.'}, {'ForeName': 'Marsha M', 'Initials': 'MM', 'LastName': 'Linehan', 'Affiliation': 'Department of Psychology, University of Washington, Seattle, Washington.'}]",Journal of personality disorders,['10.1521/pedi_2020_34_469']
3253,31611038,"Effects of tesamorelin on non-alcoholic fatty liver disease in HIV: a randomised, double-blind, multicentre trial.","BACKGROUND
Non-alcoholic fatty liver disease (NAFLD) is a substantial cause of comorbidity in people with HIV and there are no proven pharmacological treatments for the disease in this population. We assessed the effects of tesamorelin on liver fat and histology in people with HIV and NAFLD.
METHODS
This randomised, double-blind, multicentre study with identical placebo as a comparator was done in a hospital and a medical research centre in the USA. People with HIV infection and a hepatic fat fraction (HFF) of 5% or more by proton magnetic resonance spectroscopy were eligible. Participants were randomly assigned (1:1) to receive either tesamorelin 2 mg once daily or placebo once daily for 12 months, followed by a 6-month open-label phase during which all participants received tesamorelin 2 mg daily. The randomisation list was prepared by the study statistician using a permuted block algorithm within each stratum with randomly varying block sizes. The primary endpoint was change in HFF between baseline and 12 months. The primary safety endpoint was glucose. Analysis was by intention to treat using all available data. This trial is registered with ClinicalTrials.gov, number NCT02196831.
FINDINGS
61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received placebo. Patients receiving tesamorelin had a greater reduction of HFF than did patients receiving placebo, with an absolute effect size of -4·1% (95% CI -7·6 to -0·7, p=0·018), corresponding to a -37% (95% CI -67 to -7, p=0·016) relative reduction from baseline. After 12 months, 35% of individuals receiving tesamorelin and 4% receiving placebo had a HFF of less than 5% (p=0·0069). Changes in fasting glucose and glycated haemoglobin were not different between groups at 12 months. Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
INTERPRETATION
Tesamorelin might be beneficial in people with HIV and NAFLD. Further studies are needed to determine the long-term effects of tesamorelin on liver histology.
FUNDING
National Institutes of Health and National Institute of Allergy and Infectious Diseases.",2019,"Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
","['people with HIV and NAFLD', '61 patients were enrolled between Aug 20, 2015, and Jan 16, 2019, of whom 30 received tesamorelin and 30 received', 'non-alcoholic fatty liver disease in HIV', 'People with HIV infection and a hepatic fat fraction (HFF) of 5% or more by proton magnetic resonance spectroscopy were eligible']","['tesamorelin', 'tesamorelin 2 mg daily', 'tesamorelin 2 mg once daily or placebo', 'Tesamorelin', 'placebo']","['liver fat and histology', 'localised injection site complaints', 'fasting glucose and glycated haemoglobin', 'reduction of HFF', 'change in HFF']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}]","[{'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C4057885', 'cui_str': 'tesamorelin 2 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",61.0,0.787467,"Individuals in the tesamorelin group experienced more localised injection site complaints than those in the placebo group, though none were judged to be serious.
","[{'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Purdy', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Aepfelbacher', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Buckless', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Tsao', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Anela', 'Initials': 'A', 'LastName': 'Kellogg', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA; Frederick National Laboratory for Cancer Research, Frederick, MA, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Branch', 'Affiliation': 'Massachusetts General Hospital Clinical Research Center, Boston, MA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Massachusetts General Hospital Biostatistics Center, Boston, MA, USA.'}, {'ForeName': 'Chia-Ying', 'Initials': 'CY', 'LastName': 'Liu', 'Affiliation': 'Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Gastroenterology Division, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health and University of Maryland, Bethesda, MD, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: sgrinspoon@partners.org.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30338-8']
3254,32184378,Double-Triggering During Noninvasive Ventilation in a Simulated Lung Model.,"BACKGROUND
Double-triggering is a well-recognized form of patient-ventilator asynchrony in noninvasive ventilation (NIV). This benchtop simulated lung study aimed to determine under which patient and device-specific conditions double-triggering is more prevalent, and how this influences the delivery of NIV.
METHODS
Two commonly used proprietary NIV devices were tested using a benchtop lung model. Lung compliance, airway resistance, respiratory effort, and breathing frequency were manipulated, and the frequency of double-triggering was assessed. A lung model of very low lung compliance (15 mL/cm H 2 O) was then used to assess the frequency of double-triggering when breathing frequency and respiratory effort were varied, along with basic NIV settings, including inspiratory pressure and expiratory pressure. Minute ventilation and total inspiratory work (as calculated by the simulated lung model) were also correlated with frequency of double-triggering.
RESULTS
In both devices, double-triggering was observed with reduced lung compliance ( P = .02 and P < .001 for the two devices, respectively). Reduced airway resistance was associated with double-triggering with the one device only ( P = .02). Respiratory effort and breathing frequency were not independent predictors of double-triggering across all lung models. In the lung model of very low lung compliance, both devices showed increased double-triggering at a lower breathing frequency ( P < .001 and P < .001), higher respiratory effort ( P = .03 and P < .001), and greater pressure support ( P = .044, P < .001). Importantly, double-triggering was associated with reduced minute ventilation ( P = .007) with one device and increased inspiratory work ( P < .001) with the other device.
CONCLUSIONS
Both simulated-patient and device characteristics influenced the frequency of double-triggering in NIV, resulting in meaningful consequences in a simulated lung model.",2020,"In both devices, double-triggering was observed with reduced lung compliance ( P = .02 and P < .001 for the two devices, respectively).",[],['Double-Triggering During Noninvasive Ventilation'],"['greater pressure support', 'Reduced airway resistance', 'reduced lung compliance', 'Respiratory effort and breathing frequency', 'inspiratory pressure and expiratory pressure', 'Lung compliance, airway resistance, respiratory effort, and breathing frequency', 'inspiratory work', 'breathing frequency', 'Minute ventilation and total inspiratory work', 'reduced minute ventilation']",[],"[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0024112', 'cui_str': 'Lung Compliance'}, {'cui': 'C0425466', 'cui_str': 'Respiratory effort (observable entity)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.295115,"In both devices, double-triggering was observed with reduced lung compliance ( P = .02 and P < .001 for the two devices, respectively).","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Sheehy', 'Affiliation': 'Department of Respiratory & Sleep Medicine and Sleep Disorders Centre, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia. robert.sheehy@health.qld.gov.au.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Duce', 'Affiliation': 'Department of Respiratory & Sleep Medicine and Sleep Disorders Centre, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Edwards', 'Affiliation': 'Department of Respiratory & Sleep Medicine and Sleep Disorders Centre, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Churton', 'Affiliation': 'Department of Respiratory & Sleep Medicine and Sleep Disorders Centre, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Department of Respiratory & Sleep Medicine and Sleep Disorders Centre, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Hukins', 'Affiliation': 'Department of Respiratory & Sleep Medicine and Sleep Disorders Centre, Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.'}]",Respiratory care,['10.4187/respcare.07280']
3255,32044621,Diclofenac versus a combination of hyoscine and diclofenac for outpatient hysteroscopy: A placebo controlled randomized clinical trial.,"OBJECTIVE
to compare the effect of administering diclofenac sodium and/or oral hyoscine in pain perception during and after outpatient diagnostic hysteroscopy without anesthesia.
STUDY DESIGN
a randomized, double-blind placebo-controlled clinical trial was performed in an University Hospital. We included 217 patients submitted to office hysteroscopy for the following indications: diagnosis of abnormal uterine bleeding, endometrial polyps, submucous myomas, infertility and recurrent miscarriage. Patients were allocated into 3 groups: (Group 1) placebo, (Group 2) diclofenac sodium 50 mg and (Group 3) diclofenac sodium 50 mg plus Hyoscine-N-Butylbromide 10 mg. The primary outcome was the visual analogue score immediately after the procedure. The secondary outcomes included Likert acceptance scale, the need for extra analgesia after the procedure, need to stay in the observation room and the occurrence of vagal symptoms.
RESULTS
Groups were similar according to age, color, age of menarche, gravity, c-section, abortion, presence of pelvic pain, presence of uterine scar, height and body mass index. Patients in all three groups demonstrated similar visual pain scores when submitted to office hysteroscopy (Group 1: 4.18 ± 3.1, Group 2: 4.68 ± 2.9, group 3: 4.45 ± 2.9, P = 0.59). Moreover, patients presented high acceptance scores of the procedure, similar between groups. We performed a subgroup analysis in patients in treatment for chronic pelvic pain and, in this subgroup, prior medication with diclofenac sodium isolated or associated with hyoscine were both effective in decreasing pain levels when compared to placebo (Group 1: 6.0 ± 1.9, Group 2: 3.6 ± 2.1, group 3: 4.2 ± 1.5, P = 0.04).
CONCLUSION(S)
Office hysteroscopy is a well tolerated procedure and prior use of analgesic medication was not effective in decreasing pain. In selected patients with chronic pelvic pain the use prior analgesic medication may be beneficial.",2020,"Patients in all three groups demonstrated similar visual pain scores when submitted to office hysteroscopy (Group 1: 4.18 ± 3.1, Group 2: 4.68 ± 2.9, group 3: 4.45 ± 2.9, P = 0.59).","['outpatient hysteroscopy', '217 patients submitted to office hysteroscopy for the following indications: diagnosis of abnormal uterine bleeding, endometrial polyps, submucous myomas, infertility and recurrent miscarriage', 'pain perception during and after outpatient diagnostic hysteroscopy without anesthesia', 'selected patients with chronic pelvic pain', 'University Hospital']","['diclofenac sodium', 'Diclofenac', 'diclofenac sodium and/or oral hyoscine', 'hyoscine and diclofenac', 'placebo', 'diclofenac sodium 50 mg plus Hyoscine-N-Butylbromide 10 mg', 'hyoscine']","['visual pain scores', 'visual analogue score', 'pain', 'pain levels', 'Likert acceptance scale, the need for extra analgesia after the procedure, need to stay in the observation room and the occurrence of vagal symptoms']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0020710', 'cui_str': 'Uterine Endoscopy'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C3650625', 'cui_str': 'Abnormal uterine bleeding (disorder)'}, {'cui': 'C1704273', 'cui_str': 'Endometrial adenoma'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0000809', 'cui_str': 'Recurrent Early Pregnancy Loss'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036442', 'cui_str': 'Scopolamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2710094', 'cui_str': 'Diclofenac Sodium 50 MG'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006519', 'cui_str': 'butylscopolamine bromide'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0222045'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",217.0,0.225132,"Patients in all three groups demonstrated similar visual pain scores when submitted to office hysteroscopy (Group 1: 4.18 ± 3.1, Group 2: 4.68 ± 2.9, group 3: 4.45 ± 2.9, P = 0.59).","[{'ForeName': 'Carlos A B', 'Initials': 'CAB', 'LastName': 'Souza', 'Affiliation': 'Obstetrics-Gynecology Department, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil. Electronic address: cbsouza@hcpa.edu.br.'}, {'ForeName': 'Vanessa K', 'Initials': 'VK', 'LastName': 'Genro', 'Affiliation': 'Obstetrics-Gynecology Department, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Diego V', 'Initials': 'DV', 'LastName': 'Tarrasconi', 'Affiliation': 'Obstetrics-Gynecology Department, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Maria L R', 'Initials': 'MLR', 'LastName': 'Oppermann', 'Affiliation': 'Obstetrics-Gynecology Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'João S L', 'Initials': 'JSL', 'LastName': 'Cunha Filho', 'Affiliation': 'Obstetrics-Gynecology Department, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.01.030']
3256,31650650,Use of urinary balloon catheter to prevent postoperative bleeding after ultrasound-guided vacuum-assisted breast biopsy.,"Postoperative bleeding is the most frequent serious complications after vacuum-assisted breast biopsy (VABB). The aim of this study was to evaluate the clinical effect of using urinary balloon catheter to prevent postoperative bleeding after ultrasound-guided VABB. From May 2016 to June 2018, 324 patients who underwent ultrasound-guided VABB were randomized into the study group and control group. In the study group, an urinary balloon catheter was inserted into the excision cavity to prevent bleeding and hematoma. In the control group, compression with thorax pressure bandage was used for hemostasis. Postoperative subcutaneous ecchymosis and hematoma were recorded and compared between the two groups. The rates of postoperative ecchymosis and hematoma in the study group were significantly lower than that in the control group (5.6% vs 13.0%, P < .05; 8.0% vs 20.4%, P < .05). Among patients with lesions ≤1.5 cm, the rates of postoperative ecchymosis and hematoma were 2.9% and 4.3% in the study group, 6.5% and 11.7% in the control group, but there was no statistically significant difference between the two groups (P > .05). Among patients with lesions >1.5 cm, the rates of postoperative ecchymosis and hematoma in the study group were significantly lower than that in the control group (7.6% vs 18.8%, P < .05; 10.9% vs 28.2%, P < .05). Hemostasis with balloon urinary catheter is a safe and effective method to prevent postoperative bleeding after VABB.",2020,"The rates of postoperative ecchymosis and hematoma in the study group were significantly lower than that in the control group (5.6% vs 13.0%, P ","['From May 2016 to June 2018, 324 patients who underwent ultrasound-guided VABB']","['compression with thorax pressure bandage', 'urinary balloon catheter', 'ultrasound-guided vacuum-assisted breast biopsy', 'balloon urinary catheter', 'ultrasound-guided VABB']","['Postoperative bleeding', 'rates of postoperative ecchymosis and hematoma', 'postoperative bleeding', 'Postoperative subcutaneous ecchymosis and hematoma']","[{'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0150468', 'cui_str': 'Application of bandage (procedure)'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0405352', 'cui_str': 'Biopsy of breast (procedure)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}]","[{'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]",324.0,0.0247479,"The rates of postoperative ecchymosis and hematoma in the study group were significantly lower than that in the control group (5.6% vs 13.0%, P ","[{'ForeName': 'Zhen-Qiang', 'Initials': 'ZQ', 'LastName': 'Lian', 'Affiliation': 'The First Clinical Medical College of Jinan University, Jinan University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Hai-Yun', 'Initials': 'HY', 'LastName': 'Yu', 'Affiliation': 'Breast disease center, Guangdong Women and Children Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'An-Qin', 'Initials': 'AQ', 'LastName': 'Zhang', 'Affiliation': 'Breast disease center, Guangdong Women and Children Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Si-Mei', 'Initials': 'SM', 'LastName': 'Xie', 'Affiliation': 'Breast disease center, Guangdong Women and Children Hospital, Guangzhou, Guangdong, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'The First Clinical Medical College of Jinan University, Jinan University, Guangzhou, Guangdong, China.'}]",The breast journal,['10.1111/tbj.13484']
3257,31833801,"Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial.","Background: The aim was to assess the safety and tolerability of the insulin aspart biosimilar/follow-on product SAR341402 (100 U/mL solution; SAR-Asp) and originator insulin aspart (100 U/mL; NN-Asp; NovoLog ® ) self-administered through an insulin pump. Materials and Methods: This randomized, open-label, 2 × 4-week crossover study enrolled 45 adults with type 1 diabetes (T1D). Participants were randomized 1:1 to the treatment sequence SAR-Asp/NN-Asp or NN-Asp/SAR-Asp. The basal and prandial insulin doses were individually titrated. The primary outcome was the number of participants with at least one infusion set occlusion (infusion set change due to failure-to-correct hyperglycemia [plasma glucose ≥250 mg/dL] by insulin pump bolus) during the 4-week treatment. The main secondary outcome was the number of participants with at least one episode of unexplained hyperglycemia (regardless of correction by an insulin pump bolus without apparent material defect, medical, dietary, insulin dosing reason, or pump problem). Results: The number of participants reporting ≥1 infusion set occlusion were similar between treatments: 14/43 on SAR-Asp (33 events) and 12/43 on NN-Asp (24 events). The estimated difference in infusion set occlusion risk for SAR-Asp versus NN-Asp was 4.1% (95% confidence interval: -9.3% to 17.4%). The number of participants with ≥1 episode of unexplained hyperglycemia was similar between treatments (31/43 on SAR-Asp [154 events]; 32/43 on NN-Asp [175 events]). Hypoglycemia, treatment-emergent adverse events, hypersensitivity, and injection site reactions were similar between treatments. Conclusions: SAR-Asp and NN-Asp were well tolerated and had similar infusion set occlusions over a 4-week period in insulin pump users with T1D.",2020,The number of participants with ≥1 episode of unexplained hyperglycemia was similar between treatments (31/43 on SAR-Asp [154 events]; 32/43 on NN-Asp [175 events]).,"['45 adults with type 1 diabetes (T1D', 'Adults with Type 1 Diabetes']","['insulin aspart biosimilar/follow-on product SAR341402 (100\u2009U/mL solution; SAR-Asp) and originator insulin aspart', 'Insulin Aspart Biosimilar SAR341402', 'Originator Insulin Aspart (NovoLog', 'treatment sequence SAR-Asp/NN-Asp or NN-Asp/SAR-Asp']","['safety and tolerability', 'number of participants with at least one infusion set occlusion (infusion set change due to failure-to-correct hyperglycemia [plasma glucose', 'number of participants with at least one episode of unexplained hyperglycemia (regardless of correction by an insulin pump bolus without apparent material defect, medical, dietary, insulin dosing reason, or pump problem', 'Hypoglycemia, treatment-emergent adverse events, hypersensitivity, and injection site reactions', 'number of participants reporting ≥1 infusion set occlusion', 'unexplained hyperglycemia', 'Safety and Tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1175743', 'cui_str': 'Severe acute respiratory syndrome-related coronavirus'}, {'cui': 'C0206298', 'cui_str': 'European Viper'}, {'cui': 'C0939412', 'cui_str': 'NovoLog'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",45.0,0.133699,The number of participants with ≥1 episode of unexplained hyperglycemia was similar between treatments (31/43 on SAR-Asp [154 events]; 32/43 on NN-Asp [175 events]).,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Thrasher', 'Affiliation': 'Medical Investigations, Inc., Little Rock, Arkansas.'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Polsky', 'Affiliation': 'Department of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Hovsepian', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Nowotny', 'Affiliation': 'Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Pierre', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Bois De Fer', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes & Endocrinology Research Center, West Des Moines, Iowa.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Satish K', 'Initials': 'SK', 'LastName': 'Garg', 'Affiliation': 'Department of Medicine and Pediatrics, Barbara Davis Center for Diabetes, University of Colorado, Denver, Colorado.'}]",Diabetes technology & therapeutics,['10.1089/dia.2019.0446']
3258,31872869,Short-term outcomes of a multicentre randomized clinical trial comparing D2 versus D3 lymph node dissection for colonic cancer (COLD trial).,"BACKGROUND
It remains unclear whether extended lymphadenectomy provides oncological advantages in colorectal cancer. This multicentre RCT aimed to address this issue.
METHODS
Patients with resectable primary colonic cancer were enrolled in four hospitals registered in the COLD trial, and randomized to D2 or D3 dissection in a 1 : 1 ratio. Data were analysed to assess the safety of D3 dissection.
RESULTS
The study included the first 100 patients randomized in this ongoing trial. Ninety-nine patients were included in the intention-to-treat (ITT) analysis (43 D2, 56 D3). Ninety-two patients received the allocated treatment and were included in the per-protocol (PP) analysis: 39 of 43 in the D2 group and 53 of 56 in the D3 group. There were no deaths. The 30-day postoperative morbidity rate was 47 per cent in the D2 group and 48 per cent in the D3 group, with a risk ratio of 1·04 (95 per cent c.i. 0·68 to 1·58) (P = 0·867). There were two anastomotic leaks (5 per cent) in the D2 group and none in the D3 group. Postoperative recovery, complication and readmission rates did not differ between the groups in ITT and PP analyses. Mean lymph node yield was 26·6 and 27·8 in D2 and D3 procedures respectively. Good quality of complete mesocolic excision was more frequently noted in the D3 group (P = 0·048). Three patients in the D3 group (5 per cent) had metastases in D3 lymph nodes. D3 was never the only affected level of lymph nodes. N-positive status was more common in the D3 group (46 per cent versus 26 per cent in D2), with a risk ratio of 1·81 (95 per cent c.i. 1·01 to 3·24) (P = 0·044).
CONCLUSION
D3 lymph node dissection is feasible and may be associated with better N staging. Registration number: NCT03009227 ( http://www.clinicaltrials.gov).",2020,There were two anastomotic leaks (5 per cent) in the D2 group and none in the D3 group.,"['Ninety-two patients received the allocated treatment and were included in the per-protocol (PP) analysis: 39 of 43 in the D2 group and 53 of 56 in the D3 group', 'Ninety-nine patients were included in the intention-to-treat (ITT) analysis (43 D2, 56 D3', '0·68 to 1·58', '1·01 to 3·24', 'Patients with resectable primary colonic cancer were enrolled in four hospitals registered in the COLD trial, and randomized to D2 or D3 dissection in a 1\xa0:\xa01 ratio']",['D2 versus D3 lymph node dissection'],"['Mean lymph node yield', 'anastomotic leaks', 'safety of D3 dissection', 'Good quality of complete mesocolic excision', '30-day postoperative morbidity rate', 'Postoperative recovery, complication and readmission rates']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C2960226', 'cui_str': 'D3 lymph node dissection (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",56.0,0.231087,There were two anastomotic leaks (5 per cent) in the D2 group and none in the D3 group.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karachun', 'Affiliation': 'Surgical Department of Abdominal Oncology, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Panaiotti', 'Affiliation': 'Surgical Department of Abdominal Oncology, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Chernikovskiy', 'Affiliation': 'Clinical Research Centre of Specialized Kinds of Medical Care (Oncology), Saint Petersburg, Russia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Achkasov', 'Affiliation': 'Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gevorkyan', 'Affiliation': 'Rostov Research Institute of Oncology, Rostov-on-Don, Russia.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Savanovich', 'Affiliation': 'Clinical Research Centre of Specialized Kinds of Medical Care (Oncology), Saint Petersburg, Russia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sharygin', 'Affiliation': 'Clinical Research Centre of Specialized Kinds of Medical Care (Oncology), Saint Petersburg, Russia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Markushin', 'Affiliation': 'Clinical Research Centre of Specialized Kinds of Medical Care (Oncology), Saint Petersburg, Russia.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Sushkov', 'Affiliation': 'Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aleshin', 'Affiliation': 'Operational Unit, Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Shakhmatov', 'Affiliation': 'Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Nazarov', 'Affiliation': 'Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Muratov', 'Affiliation': 'Oncology and Colon Surgery Department, State Scientific Centre of Coloproctology, Moscow, Russia.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Maynovskaya', 'Affiliation': 'Pathology Department, State Scientific Centre of Coloproctology, Moscow, Russia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Olkina', 'Affiliation': 'Surgical Department of Abdominal Oncology, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lankov', 'Affiliation': 'Surgical Department of Abdominal Oncology, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ovchinnikova', 'Affiliation': 'Pathology Department, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kharagezov', 'Affiliation': 'Rostov Research Institute of Oncology, Rostov-on-Don, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaymakchi', 'Affiliation': 'Rostov Research Institute of Oncology, Rostov-on-Don, Russia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Milakin', 'Affiliation': 'Rostov Research Institute of Oncology, Rostov-on-Don, Russia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Petrov', 'Affiliation': 'Surgical Department of Abdominal Oncology, N. N. Petrov National Medical Research Centre of Oncology, Saint Petersburg, Russia.'}]",The British journal of surgery,['10.1002/bjs.11387']
3259,32077553,Randomized Clinical Trial of Intravenous (IV) Acetaminophen as an Adjunct to IV Hydromorphone for Acute Severe Pain in Emergency Department Patients.,"BACKGROUND
A fundamental challenge for emergency department (ED) clinicians is to relieve severe, acute pain while simultaneously avoiding adverse events associated with opioid analgesics. Because there is evidence that intravenous (IV) acetaminophen is an effective adjuvant analgesic in postoperative settings, we examined whether it also has a role in the ED.
METHODS
This was a two-arm, double-blind randomized clinical trial. All patients received 1 mg of IV hydromorphone. Patients were then randomized to receive 1 g of IV acetaminophen or placebo. The primary outcome was the between-group difference in change in pain from baseline (before treatment) to 60 minutes after administration of study drugs, measured on an 11-point numeric rating scale (NRS).
RESULTS
Of 828 patients screened, 162 were enrolled and 159 had the primary outcome. Patients allocated to acetaminophen + hydromorphone had a mean decline in pain from baseline to 60 minutes of 6.2 NRS units; those receiving placebo + hydromorphone had a mean decline of 5.4, a difference of 0.8 NRS units (95% confidence interval [CI] = -0.01 to 1.8). Two patients in each group received additional analgesics in the first 60 minutes of the study. At 120 minutes the NRS pain difference was 0.6 (95% CI = -0.4 to 1.6). A total of 26.9% of patients who received acetaminophen wanted more analgesia versus 37.7% of those given placebo (difference = -10.8%, 95% CI = -24.3% to 4.4%). The incidence of adverse effects was similar in both groups.
CONCLUSIONS
The addition of 1 g of IV acetaminophen to 1 mg of IV hydromorphone provided neither clinically meaningful nor statistically superior analgesia than hydromorphone alone.",2020,"26.9% of patients who received acetaminophen wanted more analgesia, versus 37.7% of those given placebo (difference -10.8%, 95% CI: -24.3%, 4.4%).","['828 patients screened, 162 were enrolled and 159 had the primary outcome', 'Emergency Department Patients']","['Acetaminophen', 'intravenous (IV) acetaminophen', 'placebo', 'additional analgesics', 'Hydromorphone', 'hydromorphone', 'placebo + hydromorphone', 'acetaminophen + hydromorphone', 'acetaminophen or placebo', 'acetaminophen']","['change in pain', '11-point numerical rating scale (NRS', 'analgesia', 'NRS pain difference', 'Incidence of adverse effects', 'mean decline in pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",162.0,0.792846,"26.9% of patients who received acetaminophen wanted more analgesia, versus 37.7% of those given placebo (difference -10.8%, 95% CI: -24.3%, 4.4%).","[{'ForeName': 'Polly E', 'Initials': 'PE', 'LastName': 'Bijur', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Friedman', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'White', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wollowitz', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Jones', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Chang', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Gallagher', 'Affiliation': 'From the, Department of Emergency Medicine, Albert Einstein College of Medicine, Bronx, NY.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13947']
3260,31738283,"Effect of Dextrose Prolotherapy on Pain Intensity, Disability, and Plantar Fascia Thickness in Unilateral Plantar Fasciitis: A Randomized, Controlled, Double-Blind Study.","OBJECTIVE
The aim of the study was to evaluate the efficacy of dextrose prolotherapy in the treatment of chronic resistant plantar fasciitis through comparison with a control group.
DESIGN
In this double-blind, randomized, controlled study, the patients were divided into two groups. The prolotherapy group (n = 30) was administered 5 ml of 30% dextrose, 4 ml of saline, and 1 ml of 2% lidocaine mixture (15% dextrose solution) and the control group was given 9 ml of saline and 1 ml of 2% lidocaine mixture twice at a 3-wk interval. During the 15-wk follow-up period, pain intensity was measured using the visual analog scale during activity and at rest. The foot function index was used to measure pain and disability. The plantar fascia thickness was measured by ultrasonography. The measurements were undertaken before treatment and at posttreatment weeks 7 and 15.
RESULTS
Improvements in visual analog scale during activity, at rest, foot function index (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared with the control group (P < 0.001).
CONCLUSIONS
Dextrose prolotherapy has efficacy up to 15 wks and can be used as an alternative method in the treatment of chronic resistant plantar fasciitis.",2020,"RESULTS
Improvements in VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared to the control group (p>0.001).
","['chronic resistant plantar fasciitis (PF', 'Unilateral Plantar Fasciitis']","['Dextrose prolotherapy', 'Dextrose Prolotherapy', '5 cc 30% dextrose, 4 cc saline, 1cc 2% lidocaine mixture (15% dextrose solution) and the control group was given 9 cc saline and 1 cc 2% lidocaine mixture', 'prolotherapy', 'dextrose prolotherapy']","['visual analog scale during activity (VAS-A) and at rest (VAS-R', 'pain and disability', 'VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness', 'plantar fascia thickness', 'pain intensity', 'foot function index (FFI', 'Pain Intensity, Disability and Plantar Fascia Thickness']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0149756', 'cui_str': ""Policeman's Heel""}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}]","[{'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C0500223', 'cui_str': 'Proliferation Therapy'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0078085', 'cui_str': 'VAS-A'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0549109', 'cui_str': 'Plantar fascia structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index (assessment scale)'}]",,0.0651174,"RESULTS
Improvements in VAS-A, VAS-R, FFI (all subgroups), and plantar fascia thickness measured at the 7th and 15th weeks were significantly higher in the prolotherapy group compared to the control group (p>0.001).
","[{'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Mansiz-Kaplan', 'Affiliation': 'From the Department of Physical Medicine and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Nacir', 'Affiliation': ''}, {'ForeName': 'Secil', 'Initials': 'S', 'LastName': 'Pervane-Vural', 'Affiliation': ''}, {'ForeName': 'Burcu', 'Initials': 'B', 'LastName': 'Duyur-Cakit', 'Affiliation': ''}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Genc', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001330']
3261,31959264,Baseline diet modifies the effects of dietary change.,"The Dietary Approaches to Stop Hypertension (DASH) eating pattern has been shown to reduce blood pressure (BP) in previous clinical trials. In the PREMIER study, an established behavioural intervention, with or without DASH, promoted greater weight loss than an advice-only control group, but effects of the DASH intervention on BP were weaker. In these analyses, PREMIER data were used to evaluate whether change in dairy product or fruit and vegetable (FV) intake during the first six intervention months impacted changes in weight and/or BP. Study participants were classified as having low or high intakes of dairy products (<1·5 v. ≥1·5 servings/d) and FV (<5 v. ≥5 servings/d) at baseline and 6 months. For dairy products, in particular, participants with higher baseline intakes tended to decrease their intakes during the intervention. In these analyses, subjects consuming <1·5 dairy servings/d at baseline whose intake increased during the intervention lost more weight than those whose intake decreased or remained low throughout (10·6 v. 7·0 pounds (4·8 v. 3·2 kg) lost, respectively, P = 0·002). The same was true for FV intake (11·0 v. 5·9 pounds (5·0 v. 2·7 kg) lost, P < 0·001). We also found synergistic effects of dairy products and FV on weight loss and BP reduction. Specifically, subjects who increased their intakes of dairy products and also consumed ≥5 servings of FV/d lost more weight and had greater reductions in BP than other groups; in addition, higher FV intakes had the greatest benefit to BP among those consuming more dairy products. These results provide evidence that the DASH pattern was most beneficial to individuals whose baseline diet was less consistent with DASH.",2020,"The same was true for FV intake (11.0 vs. 5.9 pounds lost, p<0.001).",['Study participants were classified as having low or high intakes of dairy (<1.5 vs. ≥1.5 servings/day) and FV (<5 vs. ≥5 servings/day) at baseline and six months'],['DASH intervention'],"['weight and/or BP', 'weight loss', 'weight loss and BP reduction', 'change in dairy or fruits and vegetable (FV) intake', 'BP', 'blood pressure (BP']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0209521,"The same was true for FV intake (11.0 vs. 5.9 pounds lost, p<0.001).","[{'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Pickering', 'Affiliation': 'Preventive Medicine & Epidemiology, Department of Medicine, Boston University School of Medicine, Boston, MA02118, USA.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Bradlee', 'Affiliation': 'Preventive Medicine & Epidemiology, Department of Medicine, Boston University School of Medicine, Boston, MA02118, USA.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Singer', 'Affiliation': 'Preventive Medicine & Epidemiology, Department of Medicine, Boston University School of Medicine, Boston, MA02118, USA.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Moore', 'Affiliation': 'Preventive Medicine & Epidemiology, Department of Medicine, Boston University School of Medicine, Boston, MA02118, USA.'}]",The British journal of nutrition,['10.1017/S0007114520000112']
3262,31535609,Coping in context: The effects of long-term relations between interparental conflict and coping on the development of child psychopathology following parental divorce.,"Exposure to high levels of postdivorce interparental conflict is a well-documented risk factor for the development of psychopathology, and there is strong evidence of a subpopulation of families for which conflict persists for many years after divorce. However, existing studies have not elucidated differential trajectories of conflict within families over time, nor have they assessed the risk posed by conflict trajectories for development of psychopathology or evaluated potential protective effects of children's coping to mitigate such risk. We used growth mixture modeling to identify longitudinal trajectories of child-reported conflict over a period of six to eight years following divorce in a sample of 240 children. We related the trajectories to children's mental health problems, substance use, and risky sexual behaviors and assessed how children's coping prospectively predicted psychopathology in the different conflict trajectories. We identified three distinct trajectories of conflict; youth in two high-conflict trajectories showed deleterious effects on measures of psychopathology at baseline and the six-year follow-up. We found both main effects of coping and coping by conflict trajectory interaction effects in predicting problem outcomes at the six-year follow-up. The study supports the notion that improving youth's general capacity to cope adaptively is a potentially modifiable protective factor for all children facing parental divorce and that children in families with high levels of postdivorce conflict are a particularly appropriate group to target for coping-focused preventive interventions.",2019,The study supports the notion that improving youth's general capacity to cope adaptively is a potentially modifiable protective factor for all children facing parental divorce and that children in families with high levels of postdivorce conflict are a particularly appropriate group to target for coping-focused preventive interventions.,"['240 children', 'child psychopathology following parental divorce']",[],[],"[{'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}]",[],[],240.0,0.0227535,The study supports the notion that improving youth's general capacity to cope adaptively is a potentially modifiable protective factor for all children facing parental divorce and that children in families with high levels of postdivorce conflict are a particularly appropriate group to target for coping-focused preventive interventions.,"[{'ForeName': 'Karey L', 'Initials': 'KL', 'LastName': ""O'Hara"", 'Affiliation': 'REACH Institute, Arizona State University, Tempe, Arizona 85287, USA.'}, {'ForeName': 'Irwin N', 'Initials': 'IN', 'LastName': 'Sandler', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, Arizona 85287, USA.'}, {'ForeName': 'Sharlene A', 'Initials': 'SA', 'LastName': 'Wolchik', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, Arizona 85287, USA.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, Arizona 85287, USA.'}]",Development and psychopathology,['10.1017/S0954579419000981']
3263,31940698,A Randomized Trial of Erythropoietin for Neuroprotection in Preterm Infants.,"BACKGROUND
High-dose erythropoietin has been shown to have a neuroprotective effect in preclinical models of neonatal brain injury, and phase 2 trials have suggested possible efficacy; however, the benefits and safety of this therapy in extremely preterm infants have not been established.
METHODS
In this multicenter, randomized, double-blind trial of high-dose erythropoietin, we assigned 941 infants who were born at 24 weeks 0 days to 27 weeks 6 days of gestation to receive erythropoietin or placebo within 24 hours after birth. Erythropoietin was administered intravenously at a dose of 1000 U per kilogram of body weight every 48 hours for a total of six doses, followed by a maintenance dose of 400 U per kilogram three times per week by subcutaneous injection through 32 completed weeks of postmenstrual age. Placebo was administered as intravenous saline followed by sham injections. The primary outcome was death or severe neurodevelopmental impairment at 22 to 26 months of postmenstrual age. Severe neurodevelopmental impairment was defined as severe cerebral palsy or a composite motor or composite cognitive score of less than 70 (which corresponds to 2 SD below the mean, with higher scores indicating better performance) on the Bayley Scales of Infant and Toddler Development, third edition.
RESULTS
A total of 741 infants were included in the per-protocol efficacy analysis: 376 received erythropoietin and 365 received placebo. There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P = 0.80). There were no significant differences between the groups in the rates of retinopathy of prematurity, intracranial hemorrhage, sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, or death or in the frequency of serious adverse events.
CONCLUSIONS
High-dose erythropoietin treatment administered to extremely preterm infants from 24 hours after birth through 32 weeks of postmenstrual age did not result in a lower risk of severe neurodevelopmental impairment or death at 2 years of age. (Funded by the National Institute of Neurological Disorders and Stroke; PENUT ClinicalTrials.gov number, NCT01378273.).",2020,"There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P = 0.80).","['941 infants who were born at 24 weeks 0 days to 27 weeks 6 days of gestation to receive', 'within 24 hours after birth', '741 infants were included in the per-protocol efficacy analysis: 376 received', 'Preterm Infants']","['placebo', 'Placebo', 'Erythropoietin', 'erythropoietin or placebo', 'erythropoietin']","['rates of retinopathy of prematurity, intracranial hemorrhage, sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, or death or in the frequency of serious adverse events', 'death or severe neurodevelopmental impairment', 'severe cerebral palsy or a composite motor or composite cognitive score', 'severe neurodevelopmental impairment or death', 'incidence of death or severe neurodevelopmental impairment', 'Severe neurodevelopmental impairment']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}]","[{'cui': 'C0035344', 'cui_str': 'Retrolental Fibroplasia'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",941.0,0.767138,"There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P = 0.80).","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Wadhawan', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Kaashif A', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bendel-Stenzel', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Baserga', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Edmund F', 'Initials': 'EF', 'LastName': 'LaGamma', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'L Corbin', 'Initials': 'LC', 'LastName': 'Downey', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Fahim', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz Iii', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Janine Y', 'Initials': 'JY', 'LastName': 'Khan', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Robin K', 'Initials': 'RK', 'LastName': 'Ohls', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Perez', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'McKay', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lowe', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Kuban', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'T Michael', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Hartman', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': ""From the University of Washington, Seattle (S.E.J., B.A.C., D.E.M., P.T.V., P.J.H.); Florida Hospital Orlando, Orlando (R.W.), the University of Florida, Gainesville (M.W.), South Miami Hospital, South Miami (J.E.P.), and Johns Hopkins All Children's Hospital, St. Petersburg (V.M.) - all in Florida; the University of Arkansas for Medical Sciences, Little Rock (S.E.C.); the University of Louisville, Louisville, KY (T.R.); Methodist Children's Hospital, San Antonio, TX (K.A.A.); Children's Hospital and Clinics of Minnesota (E.B.-S.) and University of Minnesota Masonic Children's Hospital (R.R., N.F.), Minneapolis, and Children's Minnesota, St. Paul (A.L.) - all in Minnesota; the University of Utah, Salt Lake City (M.B.); Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY (E.F.L.); Wake Forest School of Medicine, Winston-Salem (L.C.D.), and the University of North Carolina, Chapel Hill (T.M.O.) - both in North Carolina; Beth Israel Deaconess Medical Center (I.D.F.) and Boston University (K.K.) - both in Boston; Prentice Women's Hospital (J.Y.K.) and Children's Hospital of the University of Illinois (N.S.) - both in Chicago; Johns Hopkins University, Baltimore (M.M.G.), and the National Institute of Neurological Disorders and Stroke, Bethesda (A.L.H.) - both in Maryland; and the University of New Mexico, Albuquerque (R.K.O., J.L.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1907423']
3264,31978933,"Detection of acute 3,4-methylenedioxymethamphetamine (MDMA) effects across protocols using automated natural language processing.","The detection of changes in mental states such as those caused by psychoactive drugs relies on clinical assessments that are inherently subjective. Automated speech analysis may represent a novel method to detect objective markers, which could help improve the characterization of these mental states. In this study, we employed computer-extracted speech features from multiple domains (acoustic, semantic, and psycholinguistic) to assess mental states after controlled administration of 3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin. The training/validation set comprised within-participants data from 31 healthy adults who, over four sessions, were administered MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo in randomized, double-blind fashion. Participants completed two 5-min speech tasks during peak drug effects. Analyses included group-level comparisons of drug conditions and estimation of classification at the individual level within this dataset and on two independent datasets. Promising classification results were obtained to detect drug conditions, achieving cross-validated accuracies of up to 87% in training/validation and 92% in the independent datasets, suggesting that the detected patterns of speech variability are associated with drug consumption. Specifically, we found that oxytocin seems to be mostly driven by changes in emotion and prosody, which are mainly captured by acoustic features. In contrast, mental states driven by MDMA consumption appear to manifest in multiple domains of speech. Furthermore, we find that the experimental task has an effect on the speech response within these mental states, which can be attributed to presence or absence of an interaction with another individual. These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.",2020,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"['31 healthy adults who, over four sessions, were administered']","['placebo', 'MDMA', '3,4-methylenedioxymethamphetamine (MDMA) and intranasal oxytocin', 'oxytocin']",[],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],31.0,0.130727,These results represent a proof-of-concept application of the potential of speech to provide an objective measurement of mental states elicited during intoxication.,"[{'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Agurto', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Guillermo A', 'Initials': 'GA', 'LastName': 'Cecchi', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA. gcecchi@us.ibm.com.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Norel', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ostrand', 'Affiliation': 'Computational Biology Center - Neuroscience, IBM T.J. Watson Research Center, Yorktown Heights, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Baggott', 'Affiliation': 'Addiction and Pharmacology Research Laboratory, Friends Research Institute, San Francisco, CA, USA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Wardle', 'Affiliation': 'Department of Psychology, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet de', 'Initials': 'H', 'LastName': 'Wit', 'Affiliation': 'Human Behavioral Pharmacology Laboratory, Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Gillinder', 'Initials': 'G', 'LastName': 'Bedi', 'Affiliation': 'Centre for Youth Mental Health, University of Melbourne, and Orygen National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0620-4']
3265,30634878,Computer vision technology-based face mirroring system providing mirror therapy for Bell's palsy patients.,"Purpose: Mirror therapy (MT) is an effective adjunct treatment for Bell's palsy (BP); however, a bifold mirror-based apparatus hindered the effectiveness. Besides, few studies have reported the related factors of facial embodiment. The aim of this study was to evaluate the feasibility of a novel face mirroring System (FMS) and the effects on facial embodiment in BP patients, comparing with conventional mirror book (MB) therapy. Method: This was a within-subject design trial. Thirty-six BP patients were recruited and received investigations on user experience and perception of facial embodiment after each facial task (reset, facial expression, and enunciation) when using both FMS and MB separately and randomly. Results: Data of questionnaires showed FMS had a better user experience and perception of facial embodiment comparing with MB. Patients agreed more strongly on the statements of facial embodiment for facial expression and enunciation tasks when using both apparatuses, comparing with rest. Conclusions: The FMS is a feasible and optimal setup to provide MT for BP patients. Moreover, speech paired motor training is a superior strategy for facilitating facial embodiment.Implications for RehabilitationThe Face Mirroring System is a feasible and optimal apparatus for mirror therapy in Bell's palsy patients.Perception of facial embodiment can be increased via combining multiple sensory feedbacks.Speech paired motor tasks have considerable potential to facilitate facial embodiment.",2020,"Patients agreed more strongly on the statements of facial embodiment for facial expression and enunciation tasks when using both apparatuses, comparing with rest.
","['Thirty-six BP patients', ""Bell's palsy patients"", ""Bell's palsy (BP"", 'BP patients']","['Mirror therapy (MT', 'novel face mirroring System (FMS', 'speech paired motor training', 'conventional mirror book (MB) therapy', 'Rehabilitation', 'Computer vision technology-based face mirroring system providing mirror therapy']",['facial embodiment for facial expression and enunciation tasks'],"[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376175', 'cui_str': 'Facial Paralysis, Idiopathic'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015457', 'cui_str': 'Facial Expression'}]",36.0,0.0354589,"Patients agreed more strongly on the statements of facial embodiment for facial expression and enunciation tasks when using both apparatuses, comparing with rest.
","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Jing'an Branch Huashan Hospital, Fudan University, Shanghai, China.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'SharpSight Limited (Hongkong), Shenzhen, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shugeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Hewei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Department of Rehabilitation, Shanghai Changning Tianshan Traditional Medicine Hospital, Shanghai, China.'}, {'ForeName': 'Lianying', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Facial Palsy, Shanghai Changning Tianshan Traditional Medicine Hospital, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Huashan Hospital, Fudan University, Shanghai, China.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1510551']
3266,31778222,Impact of Intensive Blood Pressure Therapy on Concern about Falling: Longitudinal Results from the Systolic Blood Pressure Intervention Trial (SPRINT).,"OBJECTIVES
Concern about falling is common among older hypertension patients and could impact decisions to intensify blood pressure therapy. Our aim was to determine whether intensive therapy targeting a systolic blood pressure (SBP) of 120 mm Hg is associated with greater changes in concern about falling when compared with standard therapy targeting an SBP of 140 mm Hg.
DESIGN
Subsample analysis of participants randomized to either intensive or standard therapy in the Systolic Blood Pressure Intervention Trial (SPRINT).
SETTING
Approximately 100 outpatient sites.
PARTICIPANTS
A total of 2313 enrollees in SPRINT; participants were all age 50 or older (mean = 69 y) and diagnosed with hypertension.
MEASUREMENTS
Concern about falling was described by the shortened version of the Falls Efficacy Scale International as measured at baseline, 6 months, 1 year, and annually thereafter.
RESULTS
Concern about falling showed a small but significant increase over time among all hypertension patients. No differences were noted, however, among those randomized to intensive vs standard therapy (P = .95). Among participants younger than 75 years, no increase in concern about falling over time was noted, but among participants aged 75 years and older, the mean falls self-efficacy score increased by .3 points per year (P < .0001). No differences were observed between the intensive and standard treatment groups when stratified by age (P = .55).
CONCLUSION
Intensive blood pressure therapy is not associated with increased concern about falling among older hypertension patients healthy enough to participate in SPRINT. J Am Geriatr Soc 68:614-618, 2020.",2020,"No differences were observed between the intensive and standard treatment groups when stratified by age (P = .55).
","['participants younger than 75\u2009years', 'A total of 2313 enrollees in SPRINT; participants were all age 50 or older (mean = 69\u2009y) and diagnosed with hypertension', 'Approximately 100 outpatient sites', 'older hypertension patients', 'older hypertension patients healthy']","['Intensive blood pressure therapy', 'Intensive Blood Pressure Therapy', 'intensive or standard therapy', 'intensive therapy']","['systolic blood pressure (SBP', 'mean falls self-efficacy score', 'concern about falling over time', 'Falls Efficacy Scale International']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0222045'}]",2313.0,0.0996755,"No differences were observed between the intensive and standard treatment groups when stratified by age (P = .55).
","[{'ForeName': 'Dan R', 'Initials': 'DR', 'LastName': 'Berlowitz', 'Affiliation': 'Bedford VA Hospital, Bedford, University of Massachusetts Lowell, Lowell, Massachusetts.'}, {'ForeName': 'Capri', 'Initials': 'C', 'LastName': 'Foy', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Conroy', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Evans', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Olney', 'Affiliation': 'Research Service, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pisoni', 'Affiliation': 'Medical University of South Carolina, Ralph H. Johnson VA Medical Center, Charleston, South Carolina.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Powell', 'Affiliation': 'Division of General Internal Medicine, Brody School of Medicine, East Carolina University, Greenville, North Carolina.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Gure', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Ohio State Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Ronald I', 'Initials': 'RI', 'LastName': 'Shorr', 'Affiliation': 'Malcom Randall VA Medical Center, University of Florida, Gainesville, Florida.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16264']
3267,31535560,The influence of religious beliefs and practices on health care decision-making among HIV positive adolescents.,"It is unknown if religiousness/spirituality influences end-of-life treatment preferences among adolescents. Investigators assessed whether religiousness/spirituality moderates the relationship between an advance care planning intervention and end-of-life treatment preferences among 85 primarily African-American adolescents living with HIV/AIDS in outpatient-hospital-based HIV-specialty clinics in the United States. Adolescents aged 14-21 years living with HIV/AIDS and their families were randomized to three-weekly-60-minute sessions either: advance care planning (survey, goals of care conversation, advance directive); or control (developmental history, safety tips, nutrition/exercise). At 3-months post-intervention the intervention effect ( decreasing the likelihood of choosing to continue treatments in all situations ) was significantly moderated by religiousness/spirituality. Highly religious/spiritual adolescents were four times more likely to choose to continue treatments in all situations . Thus, intensive treatments at end-of-life may represent health equity, rather than health disparity. The belief believed that HIV is a punishment from God at baseline (15%, 14/94) was not associated with end-of-life treatment preferences. Twelve percent (11/94) reported they had stopped taking HIV medications for more than 3 days because of the belief in a miracle. Religiousness moderates adolescent's medical decision-making. Adolescents who believe in miracles should receive chaplaincy referrals to help maintain medication adherence.",2020,At 3-months post-intervention the intervention effect ( decreasing the likelihood of choosing to continue treatments in all situations ) was significantly moderated by religiousness/spirituality.,"['HIV positive adolescents', 'Adolescents aged 14-21 years living with HIV/AIDS and their families', '85 primarily African-American adolescents living with HIV/AIDS in outpatient-hospital-based HIV-specialty clinics in the United States', 'adolescents']","['advance care planning (survey, goals of care conversation, advance directive); or control (developmental history, safety tips, nutrition/exercise']",['stopped taking HIV medications'],"[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2930505', 'cui_str': 'Goals of Care'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0458003', 'cui_str': 'Developmental (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",85.0,0.0456278,At 3-months post-intervention the intervention effect ( decreasing the likelihood of choosing to continue treatments in all situations ) was significantly moderated by religiousness/spirituality.,"[{'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Lyon', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': ""D'Angelo"", 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}, {'ForeName': 'Yao I', 'Initials': 'YI', 'LastName': 'Cheng', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Science/Children's Research Institute, Children's National, Washington, DC, USA.""}, {'ForeName': 'Ronald H', 'Initials': 'RH', 'LastName': 'Dallas', 'Affiliation': ""Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Garvie', 'Affiliation': ""Research Department, Children's Diagnostic & Treatment Center, Fort Lauderdale, FL, USA.""}, {'ForeName': 'Jichuan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Division of Biostatistics and Study Methodology, Center for Translational Science/Children's Research Institute, Children's National, Washington, DC, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Children's National, Washington, DC, USA.""}]",AIDS care,['10.1080/09540121.2019.1668523']
3268,32068914,"Effects of the dual sodium-glucose linked transporter inhibitor, licogliflozin vs placebo or empagliflozin in patients with type 2 diabetes and heart failure.","AIMS
Explore the efficacy, safety and tolerability of the dual sodium-glucose cotransporter (SGLT) 1 and 2 inhibitor, licogliflozin in patients with type-2 diabetes mellitus (T2DM) and heart failure.
METHODS
This multicentre, parallel-group phase IIA study randomized 125 patients with T2DM and heart failure (New York Heart Association II-IV; plasma N-terminal pro b-type natriuretic peptide [NT-proBNP] >300 pg/mL) to licogliflozin (2.5 mg, 10 mg, 50 mg) taken at bedtime, empagliflozin (25 mg) or placebo (44 patients completed the study). The primary endpoint was change from baseline in NT-proBNP after 12 weeks. Secondary endpoints included change from baseline in glycated haemoglobin, fasting plasma glucose, weight, blood pressure, fasting lipid profile, high-sensitivity c-reactive protein, and safety and tolerability.
RESULTS
Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs placebo (Geometric mean ratio 0.56 [95% confidence interval: 0.33, 0.95], P = .033). A trend was observed with 50 mg licogliflozin (0.64 [95% confidence interval: 0.40, 1.03], P = .064), with no difference between licogliflozin and empagliflozin. The largest numerical decreases in glycated haemoglobin were with licogliflozin 50 mg (-0.58 ± 0.34%) and empagliflozin (-0.44 ± 1.18%) vs placebo (-0.04 ± 0.91%). The reduction in body weight was similar with licogliflozin 50 mg (-2.15 ± 2.40 kg) and empagliflozin (-2.25 ± 1.89 kg). A numerical reduction in systolic blood pressure was seen with licogliflozin 50 mg (-9.54 ± 16.88 mmHg) and empagliflozin (-6.98 ± 15.03 mmHg) vs placebo (-2.85 ± 11.97 mmHg). Adverse events (AEs) were mild, including hypotension (6.5%), hypoglycaemia (8.1%) and inadequate diabetes control (1.6%). The incidence of diarrhoea (4.9%) was lower than previously reported.
CONCLUSION
The reduction in NT-proBNP with licogliflozin suggests a potential benefit of SGLT1 and 2 inhibition in patients with T2DM and heart failure.",2020,"RESULTS
Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs. placebo (Geometric mean ratio 0.56 [95% CI: 0.33, 0.95], p=0.033).","['patients with type 2 diabetes and heart failure', 'patients with type-2 diabetes mellitus (T2DM) and heart failure', 'patients with T2DM and heart failure', '44 patients completed the study', '125 patients with T2DM and heart failure (NYHA II-IV; plasma NT-proBNP >300 pg/mL) to']","['placebo', 'Licogliflozin', 'empagliflozin', 'licogliflozin and empagliflozin', 'licogliflozin', 'dual sodium glucose co-transporter (SGLT) 1 and 2 inhibitor, licogliflozin', 'dual sodium-glucose linked transporter inhibitor, licogliflozin versus placebo or empagliflozin']","['inadequate diabetes control', 'NT-proBNP', 'body weight', 'change from baseline in NT-proBNP', 'systolic BP', 'efficacy, safety and tolerability', 'change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose, weight, blood pressure (BP), fasting lipid profile, high-sensitivity c-reactive protein, and safety and tolerability', 'Adverse events (AEs) were mild, including hypotension', 'hypoglycemia', 'incidence of diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0430044', 'cui_str': 'Fasting lipid profile (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",125.0,0.391465,"RESULTS
Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs. placebo (Geometric mean ratio 0.56 [95% CI: 0.33, 0.95], p=0.033).","[{'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario Valencia, València, Spain.'}, {'ForeName': 'Plamen', 'Initials': 'P', 'LastName': 'Kozlovski', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Proot', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14248']
3269,32113008,Force stability training decreased force variability of plantar flexor muscles without reducing postural sway in female older adults.,"BACKGROUND
Previous studies reported a relationship between postural sway and force variability of the plantar flexor muscles (PFM), such that less force variability related to lower postural sway; however, this association does not seem to exist in older adults.
RESEARCH QUESTION
This study investigated the effect of force stability training of the PFM on force variability (FV) of these muscles and postural sway in female older adults.
METHODS
Thirty female older adults were divided into three groups: TG5 (n = 10), who trained at 5% of maximum voluntary isometric contraction (MVIC) of the PFM; TG10 (n = 10), who trained at 10 % of MVIC of the PFM; and CG (n = 10) who did not perform any specific training for the PFM. Postural sway was evaluated during upright bipodal posture. Postural sway and FV of the PFM were assessed before and after the training period. Participants trained once a week for four weeks.
RESULTS
After the training period, the FV decreased significantly for both TG5 (pre = 3.26 ± 0.83; post = 2.53 ± 0.60 N) and TG10 (pre = 3.50 ± 0.72; post = 2.85 ± 0.86 N), but the mean sway amplitude increased for both TG5 (pre = 0.017 ± 0.03; post = 0.19 ± 0.04 cm) and TG10 (pre = 0.14 ± 0.04; post = 0.16 ± 0.04 cm).
SIGNIFICANCE
The force stability training decreased the FV of the PFM, but this decrease was insufficient to reduce postural sway in female older adults.",2020,"The force stability training decreased the FV of the PFM, but this decrease was insufficient to reduce postural sway in female older adults.","['Thirty female older adults', 'female older adults', 'older adults']","['TG5', 'PFM', 'maximum voluntary isometric contraction (MVIC) of the PFM; TG10 (n\u2009=\u200910), who trained at 10 % of MVIC of the PFM; and CG (n\u2009=\u200910) who did not perform any specific training for the PFM', 'Force stability training']","['Postural sway', 'Postural sway and FV of the PFM', 'mean sway amplitude', 'postural sway']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",30.0,0.0482629,"The force stability training decreased the FV of the PFM, but this decrease was insufficient to reduce postural sway in female older adults.","[{'ForeName': 'Roberto N', 'Initials': 'RN', 'LastName': 'Barbosa', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: robertonegri@usp.br.'}, {'ForeName': 'Nilson R S', 'Initials': 'NRS', 'LastName': 'Silva', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: nilsonribeiro@usp.br.'}, {'ForeName': 'Daniel P R', 'Initials': 'DPR', 'LastName': 'Santos', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: danielpeterossi@usp.br.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moraes', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: renatomoraes@usp.br.'}, {'ForeName': 'Matheus M', 'Initials': 'MM', 'LastName': 'Gomes', 'Affiliation': 'School of Physical Education and Sport of Ribeirão Preto, University of São Paulo, São Paulo, Brazil. Electronic address: mmgomes@usp.br.'}]",Gait & posture,['10.1016/j.gaitpost.2020.02.015']
3270,31707266,Predictors of adherence to nicotine replacement therapy: Machine learning evidence that perceived need predicts medication use.,"BACKGROUND
Nonadherence to smoking cessation medication is a frequent problem. Identifying pre-quit predictors of nonadherence may help explain nonadherence and suggest tailored interventions to address it.
AIMS
Identify and characterize subgroups of smokers based on adherence to nicotine replacement therapy (NRT).
METHOD
Secondary classification tree analyses of data from a 2-arm randomized controlled trial of Recommended Usual Care (R-UC, n = 315) versus Abstinence-Optimized Treatment (A-OT, n = 308) were conducted. R-UC comprised 8 weeks of nicotine patch plus brief counseling whereas A-OT comprised 3 weeks of pre-quit mini-lozenges, 26 weeks of nicotine patch plus mini-lozenges, 11 counseling contacts, and 7-11 automated reminders to use medication. Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges.
RESULTS
Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use. Greater quitting motivation and confidence, and believing that stop smoking medication was safe and easy to use were associated with greater adherence.
CONCLUSION
Adherence was especially high in those who were more dependent and more exposed to smoking triggers. Quitting motivation and confidence predicted greater adherence, while negative beliefs about medication safety and acceptability predicted worse adherence. Results suggest that adherent use of medication may reflect a rational appraisal of the likelihood that one will need medication and will benefit from it.",2019,"Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges.
RESULTS
Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use.",[],"['Usual Care (R-UC, n\u202f=\u202f315) versus Abstinence-Optimized Treatment', 'nicotine replacement therapy (NRT', 'nicotine patch plus brief counseling', 'nicotine patch plus mini-lozenges']",['Adherence'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]",[],315.0,0.0202661,"Analyses identified subgroups of smokers highly adherent to nicotine patch use in both treatment conditions, and identified subgroups of A-OT participants highly adherent to mini-lozenges.
RESULTS
Varied facets of nicotine dependence predicted adherence across treatment conditions 4 weeks post-quit and between 4- and 16-weeks post-quit in A-OT, with greater baseline dependence and greater smoking trigger exposure and reactivity predicting greater medication use.","[{'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA. Electronic address: nkim86@ctri.wisc.edu.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Wei-Yin', 'Initials': 'WY', 'LastName': 'Loh', 'Affiliation': 'Department of Statistics, University of Wisconsin, Madison, WI 53706, USA.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health, Madison, WI 53711, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107668']
3271,32149456,Effects of Group-Based Exercise on Flourishing and Stigma Consciousness among Older Adults: Findings from a Randomised Controlled Trial.,"BACKGROUND
To examine the extent to which group-based exercise programs, informed by self-categorisation theory, result in improvements in psychological flourishing and reductions in age- and gender-related stigma consciousness among older adults.
METHODS
In the study, older adults (N = 485, ≥ 65 years) were randomised to similar age same gender (SASG), similar age mixed gender (SAMG), or ""standard"" mixed age mixed gender (MAMG) group-based exercise programs. Flourishing and stigma consciousness were assessed on six occasions during the 24-week intervention and represented secondary trial outcomes. Multilevel growth models examined the effects of the interventions on flourishing and stigma consciousness over time.
RESULTS
Participants in the SASG and SAMG conditions demonstrated, on average, higher levels of flourishing, relative to the MAMG condition, over the course of the 24 weeks (p < .05). Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05). No time by group interaction effects were observed for either flourishing or stigma consciousness.
CONCLUSIONS
The results provide some support for the utility of group exercise programs, informed by self-categorisation theory, to enhance psychological flourishing and reduce stigma consciousness among older adults.",2020,"Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05).","['older adults (N\xa0=\xa0485, ≥ 65\xa0years', 'Older Adults', 'older adults']","['standard"" mixed age mixed gender (MAMG) group-based exercise programs', 'Group-Based Exercise']","['flourishing or stigma consciousness', 'Flourishing and stigma consciousness', 'Flourishing and Stigma Consciousness', 'stigma consciousness', 'flourishing and stigma consciousness', 'lower levels of age- and gender-related stigma consciousness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",,0.0385621,"Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05).","[{'ForeName': 'Geralyn R', 'Initials': 'GR', 'LastName': 'Ruissen', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Schmader', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Harden', 'Affiliation': 'Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Svenja A', 'Initials': 'SA', 'LastName': 'Wolf', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'University of Victoria, Victoria, Canada.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dunlop', 'Affiliation': 'University of California, Riverside, CA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Puterman', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Bruno D', 'Initials': 'BD', 'LastName': 'Zumbo', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12197']
3272,32179871,Gut microbiota in neonates with congenital gastrointestinal surgical conditions: a prospective study.,"BACKGROUND
There is limited information on gut microbiota of neonates with congenital gastrointestinal surgical conditions (CGISCs) available.
METHODS
This study compared stool microbiota and short-chain fatty acids (SCFAs) of 37 term infants with CGISCs with 36 term healthy infants (HIs). Two stool samples were collected from each infant: as soon as possible after birth (week 1) and 10-14 days of life (week 2).
RESULTS
Bacterial richness and alpha diversity were comparable between CGISCs and HIs at week 1 and week 2 (all p > 0.05). Beta diversity analysis revealed that at week 1, CGISCs had similar community structures to HIs (p = 0.415). However, by week 2, community structures of CGISCs were significantly different from HIs (p = 0.003). At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs. At week 2, the relative abundance of Bifidobacterium was significantly lower in CGISCs (mean percentage 7.21 ± 13.49 vs. 28.96 ± 19.6; p = 0.002). Bacteroides were also less abundant in the CGISC group (mean percentage 0.12 ± 0.49 vs. 6.59 ± 8.62; p = 0.039). Relative abundance of genera Pseudomonas and Escherichia-Shigella were higher in CGISCs. At week 2, stool concentrations of all SCFAs were lower in CGISCs (all p < 0.001).
CONCLUSIONS
During hospitalization, neonates with CGISCs develop gut dysbiosis and deficiency of SCFAs.
IMPACT
During hospitalisation, neonates with congenital gastrointestinal surgical conditions develop gut dysbiosis with deficiency of Bifidobacteria and Bacteroides and increased abundance of Escherichia-Shigella and Pseudomonas. They also have low levels of short chain fatty acids in their stools compared to healthy infants. This is the first study evaluating the gut microbiota using 16S ribosomal RNA sequencing methods and stool short chain fatty acids in neonates with congenital gastrointestinal surgical conditions and comparing them to healthy infants. The findings of this study will pave the way for randomised trials of bifidobacterial supplementation in neonates with congenital gastrointestinal surgical conditions.",2020,"At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs.","['neonates with congenital gastrointestinal surgical conditions and comparing them to healthy infants', 'neonates with congenital gastrointestinal surgical conditions (CGISCs) available', '37 term infants with CGISCs with 36 term healthy infants (HIs', 'neonates with congenital gastrointestinal surgical conditions']","['bifidobacterial supplementation', '16S ribosomal RNA sequencing methods and stool short chain fatty acids', 'stool microbiota and short-chain fatty acids (SCFAs']","['relative abundances of genera Bifidobacterium and Bacteroides', 'Relative abundance of genera Pseudomonas and Escherichia-Shigella', 'community structures of CGISCs', 'stool concentrations of all SCFAs', 'Bacteroides', 'Bacterial richness and alpha diversity', 'relative abundance of Bifidobacterium', 'Gut microbiota']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}]","[{'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Fatty Acids, Short-Chain'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0004661', 'cui_str': 'Bacteroides'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C0014833', 'cui_str': 'Escherichia'}, {'cui': 'C0036953', 'cui_str': 'Shigella'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}]",37.0,0.0788522,"At week 1, there were no significant differences in the relative abundances of genera Bifidobacterium and Bacteroides between CGISCs and HIs.","[{'ForeName': 'Shripada C', 'Initials': 'SC', 'LastName': 'Rao', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia. shripada.rao@health.wa.gov.au.""}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Esvaran', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Patole', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia.""}, {'ForeName': 'Karen N', 'Initials': 'KN', 'LastName': 'Simmer', 'Affiliation': ""Neonatal Intensive Care Unit, Perth Children's Hospital and King Edward Memorial Hospital for Women, Perth, WA, Australia.""}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gollow', 'Affiliation': ""Department of Paediatric Surgery, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keil', 'Affiliation': 'PathWest Laboratory Medicine, Perth, WA, Australia.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wemheuer', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Chemical and Biomedical Engineering, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Conway', 'Affiliation': 'Centre for Marine Science and Innovation at the University of New South Wales (UNSW), Sydney, NSW, Australia.'}]",Pediatric research,['10.1038/s41390-020-0824-7']
3273,32070847,Effects of gum chewing on glycaemic control in women with gestational diabetes mellitus: A randomized controlled trial. Impact of chewing on hyperglycaemia in women with GDM.,"BACKGROUND
The amount of chewing might be relevant in reducing hyperglycaemia in diabetic patients. The study assessed the impact of enhanced chewing on glycaemic control in women with gestational diabetes mellitus (GDM).
METHODS
As an open-label, mono-centre randomized controlled trial, 59 women with recent diagnosis of GDM were included. They received either routine care or additional chewing gum intervention. SMBG was performed for five days.
RESULTS
No significant impact on mean values of postprandial glucose levels were observed. The estimated mean differences (intervention vs. control group) were: 4.9 mg/dl, 98.4 %CI -7.2-17.1 (breakfast); -4.5 mg/dl, 98.4 %CI -15.1-6.0 (lunch); -3.8 mg/dl, 98.4 %CI -15.9 to 8.4 (dinner). OGTT levels at 60 and 120 min. were associated with glucose levels after breakfast.
CONCLUSION
In conclusion, no significant differences in blood glucose levels were observed between the groups and therefore major effects of chewing on hyperglycaemia in women with GDM could be excluded.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT03961542, Date of registration: 20.01.2019. Retrospectively registered.",2020,No significant impact on mean values of postprandial glucose levels were observed.,"['women with GDM', 'diabetic patients', 'women with gestational diabetes mellitus', '59 women with recent diagnosis of GDM were included', 'women with gestational diabetes mellitus (GDM']","['enhanced chewing', 'routine care or additional chewing gum intervention', 'SMBG', 'gum chewing']","['glucose levels', 'mean values of postprandial glucose levels', 'glycaemic control', 'blood glucose levels', 'hyperglycaemia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C4321298', 'cui_str': 'Chewing gum'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}]","[{'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]",59.0,0.130492,No significant impact on mean values of postprandial glucose levels were observed.,"[{'ForeName': 'Gülen', 'Initials': 'G', 'LastName': 'Yerlikaya-Schatten', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: guelen.yerlikaya-schatten@meduniwien.ac.at.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Trimmal', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: lisa.trimmal@gmx.net.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Rosicky', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: ingo.rosicky@meduniwien.ac.at.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Husslein', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: peter.husslein@meduniwien.ac.at.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schatten', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: christian.schatten@meduniwien.ac.at.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eppel', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: daniel.eppel@meduniwien.ac.at.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eppel', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: wolfgang.eppel@meduniwien.ac.at.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'CNR Institute of Neuroscience, Padova, Italy. Electronic address: andrea.tura@cnr.it.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Göbl', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna, Austria. Electronic address: christian.goebl@meduniwien.ac.at.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.02.003']
3274,32196793,DASH (Dietary Approaches to Stop Hypertension) dietary pattern and maternal blood pressure in pregnancy.,"BACKGROUND
High blood pressure (BP) in pregnancy is associated with significant adverse outcomes. In nonpregnant populations, the DASH (Dietary Approaches to Stop Hypertension) diet is associated with reductions in blood pressure. The present study investigated the relationship between the DASH dietary pattern and maternal BP in pregnancy.
METHODS
This is an observational study of 511 women who participated in the ROLO study (Randomized cOntrol trial of LOw glycaemic index diet for the prevention of recurrence of macrosomia), 2007-2011, Dublin, Ireland. Auscultatory blood pressure, systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements were taken. Mean arterial pressure (MAP) was calculated. Dietary intakes were recorded using 3-day food diaries in each trimester. DASH scoring criteria were used to score and rank participants from low to high intakes of foods recommended in the DASH diet. Statistical analysis using analysis of variance and multiple linear regression were used to determine the relationship between maternal BP and DASH scores.
RESULTS
Dietary intake more closely resembling the DASH dietary recommendations throughout pregnancy was associated with a lower DBP (mmHg) in trimesters 1 [B: -0.70; 95% confidence interval (CI) = -1.21 to -0.18] and 3 (B: -0.68; 95% CI = -1.19 to -0.17), as well as lower MAP (mmHg) in trimesters 1 (B: -0.78; 95% CI = -1.33 to -0.25) and 3 (B: -0.54; 95% CI = -1.04 to -0.04), controlling for body mass index, age, education, energy intake and intervention grouping.
CONCLUSIONS
The DASH dietary pattern was associated with lower maternal BP in pregnancy among healthy women without hypertensive disorders of pregnancy. Despite the observational nature of these findings, the results demonstrate the potential for healthcare professionals to intervene to promote cardiovascular health in pregnancy.",2020,"In nonpregnant populations, the DASH (Dietary Approaches to Stop Hypertension) diet is associated with reductions in blood pressure.","['511 women who participated in the ROLO study (Randomized cOntrol trial of', 'healthy women without hypertensive disorders of pregnancy']",['LOw glycaemic index diet'],"['Dietary intakes', 'maternal BP and DASH scores', 'Mean arterial pressure (MAP', 'Auscultatory blood pressure, systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements', 'blood pressure', 'maternal BP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",511.0,0.0466528,"In nonpregnant populations, the DASH (Dietary Approaches to Stop Hypertension) diet is associated with reductions in blood pressure.","[{'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Courtney', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': ""O'Brien"", 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'R K', 'Initials': 'RK', 'LastName': 'Crowley', 'Affiliation': ""Department of Endocrinology, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Geraghty', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Brady', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Kilbane', 'Affiliation': ""Department of Clinical Chemistry, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Twomey', 'Affiliation': ""Department of Clinical Chemistry, St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'McKenna', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, University College Dublin, National Maternity Hospital, Dublin, Ireland.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12744']
3275,32183768,"A multi-centre, parallel-group, randomised controlled trial to assess the efficacy and safety of eurythmy therapy and tai chi in comparison with standard care in chronically ill elderly patients with increased risk of falling (ENTAiER): a trial protocol.","BACKGROUND
In elderly poeple, multimorbidity and polypharmacy increase while sensory, motor and cognitive functions decrease. Falls occur in 30% of people aged 65 years and older at least once per year, with injuries at 10-20%. Reducing falls and enhancing physical, emotional and cognitive capacities are essential for healthy aging despite chronic disease. Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities.
METHODS
In eight trial sites (academic or community hospitals), 550 outpatients aged 65 years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score ≤ 49) will be randomly assigned (1:1:1) to receive either EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24 weeks) added to standard care or standard care alone. Standard care includes a detailed written recommendation on fall prevention and the visit of a primary care doctor. Seniors living a reclusive life or economically disadvantaged elderly will be particularly addressed. A motivation and communication concept supports the trial participants' compliance with trial procedures and practicing. Public and patient representatives are involved in the planning and conduction of the trial. Falls will be documented daily in a diary by the participants. These falls as well as injuries and complications will be ascertained during monthly phone visits. The falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH) at month 6. The trial is funded by the Federal Ministry of Education and Research (BMBF 01GL1805).
DISCUSSION
This study will determine whether EYT and Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence. A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs. TRAIL REGISTRATION: www.drks.de. DRKS00016609. Registered 30th July 2019.",2020,"A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs.","['healthy aging despite chronic disease', 'chronically ill elderly patients with increased risk of falling (ENTAiER', 'Seniors living a reclusive life or economically disadvantaged elderly', '550 outpatients aged 65\u2009years and older with chronic disease and increased risk of falling (history of imbalance, Berg Balance Scale (BBS) score\u2009≤\u200949']","['eurythmy therapy and tai chi in comparison with standard care', 'EYT or Tai Chi (each provided in one-hour group sessions, twice, later once per week plus practice at home, for over 24\u2009weeks) added to standard care or standard care alone']","['falls efficacy scale, BBS, cognition (MoCA), Mood (GDS-15), quality of life (SF12), instrumental activities of daily living (IADL), use of medical and non-medical services (FIMA) and adherence will be assessed at months 3, 6, and 12 and inner correspondence with practices (ICPH', 'efficacy and safety', 'Eurythmy therapy (EYT) and Tai Chi train balance, mobility and concentrative and sensory capacities', 'Tai Chi reduce falls, injurious falls, fear of falling and healthcare utilisation and improve mobility, cognition, mood, quality of life and functional independence', 'fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition', 'Reducing falls and enhancing physical, emotional and cognitive capacities']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0008715', 'cui_str': 'Chronically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0199168', 'cui_str': 'Medical service (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",550.0,0.0498911,"A reduction of fall risk and fear of falling and an improvement of mobility, autonomy, quality of life, mood, and cognition are highly relevant for older people to cope with aging and diseases and to reduce healthcare costs.","[{'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Kienle', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany. gunver.kienle@uniklinik-freiburg.de.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Werthmann', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Grotejohann', 'Affiliation': 'Clinical Trials Unit, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kaier', 'Affiliation': 'Institute of Medical Biometry and Statistics, Division Methods in Clinical Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Steinbrenner', 'Affiliation': 'Clinical Trials Unit, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Voigt-Radloff', 'Affiliation': 'Center for Geriatric Medicine and Gerontology Freiburg, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Huber', 'Affiliation': 'Center for Complementary Medicine; Institute for Infection Prevention and Hospital Epidemiology, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}]",BMC geriatrics,['10.1186/s12877-020-1503-6']
3276,31839677,Dual-specificity protein phosphatase DUSP4 regulates response to MEK inhibition in BRAF wild-type melanoma.,"BACKGROUND
Aiming to improve treatment options for BRAF wild-type melanoma, we previously conducted the DOC-MEK study of docetaxel with MEK inhibitor (MEKi) selumetinib or placebo, revealing trends to prolongation of progression-free survival (hazard ratio 0.75, P = 0.130), and improved response rates (32% vs 14%, P = 0.059) with docetaxel plus selumetinib. NRAS status did not associate with outcome. Here, the aim was to identify novel biomarkers of response to MEKi.
METHODS
A MEK 6 gene signature was quantified using NanoString and correlated with clinical outcomes. Two components of the gene signature were investigated by gene silencing in BRAF/NRAS wild-type melanoma cells.
RESULTS
In melanomas of patients on the selumetinib but not the placebo arm, two gene signature components, dual-specificity protein phosphatase 4 (DUSP4) and ETS translocation variant 4 (ETV4), were expressed more highly in responders than non-responders. In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib. In contrast, DUSP4-depleted cells showed enhanced cell survival and increased resistance to both selumetinib and trametinib.
CONCLUSIONS
ETV4 and DUSP4 associated with clinical response to docetaxel plus selumetinib. DUSP4 depletion induced MEKi resistance, suggesting that DUSP4 is not only a biomarker but also a mediator of MEKi sensitivity.
CLINICAL TRIAL REGISTRATION
DOC-MEK (EudraCT no: 2009-018153-23).",2020,"In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib.",['BRAF wild-type melanoma'],"['docetaxel plus selumetinib', 'docetaxel with MEK inhibitor (MEKi) selumetinib or placebo', 'placebo', 'EudraCT']","['response rates', 'dual-specificity protein phosphatase 4 (DUSP4) and ETS translocation variant 4 (ETV4', 'cell survival']","[{'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2980074'}, {'cui': 'C0752313', 'cui_str': 'MAPK-ERK Kinases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0214716', 'cui_str': 'protein phosphatase X'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0007620', 'cui_str': 'Cell Viability'}]",,0.222807,"In vitro, ETV4 depletion inhibited cell survival but did not influence sensitivity to MEKi selumetinib or trametinib.","[{'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK. avinash.gupta@christie.nhs.uk.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Towers', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Willenbrock', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Roz', 'Initials': 'R', 'LastName': 'Brant', 'Affiliation': 'Translational Science, Oncology iMED, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Darren Richard', 'Initials': 'DR', 'LastName': 'Hodgson', 'Affiliation': 'Translational Science, Oncology iMED, AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sharpe', 'Affiliation': 'Oncology iMED, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'Cancer BioSciences, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Cutts', 'Affiliation': 'Molecular Diagnostics Centre, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'Department of Cellular Pathology, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Myers', 'Affiliation': 'Experimental Cancer Medicine Centre, Oxford, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adelyn', 'Initials': 'A', 'LastName': 'Wise', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark Roy', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}, {'ForeName': 'Valentine Moya', 'Initials': 'VM', 'LastName': 'Macaulay', 'Affiliation': 'Department of Oncology, Old Road Campus Research Building, University of Oxford, Oxford, UK.'}]",British journal of cancer,['10.1038/s41416-019-0673-5']
3277,31828528,High flow nasal cannula and continuous positive airway pressure therapy in treatment of viral bronchiolitis: a randomized clinical trial.,"Continuous positive airway pressure (CPAP) has been used in infants with bronchiolitis for decades. Recently, high flow nasal cannula (HFNC) therapy was introduced. We conducted a trial of 50 children with bronchiolitis who were randomized to treatment with CPAP or HFNC. Objectives were to compare the development in respiratory rate, pCO2, and Modified Woods Clinical Asthma Score (M-WCAS) in young children with bronchiolitis, treated with CPAP or HFNC. Secondarily, to compare Neonatal Infant Pain Score (NIPS), treatment duration, treatment failure, and hospitalization length. Median age at inclusion was 2.8 (CPAP group) vs 2.1 months (HFNC group). Mean baseline pCO2 was 6.7 in both groups and mean respiratory rate was 60 vs 56 in the CPAP and HFNC group respectively. No differences were observed in development of respiratory rate, pCO2, or M-WCAS. NIPS was higher in the CPAP group. Treatment failure was scarce in both groups. No significant differences in treatment duration or length of hospitalization were observed.Conclusion: In infants and young children with bronchiolitis, HFNC may be an effective and pleasant alternative to CPAP. Larger multicenter studies are needed to further explore differences in treatment failure and treatment duration.Trial registration: www.clinicaltrial.gov. id NCT02618213, registration date December 1, 2015.What is Known:• CPAP has been used for many years for respiratory support in infant bronchiolitis. The method requires special staff skills and may be stressful to the child.• HFNC has been introduced as a newer tool.What is New:• In infants with bronchiolitis, HFNC and CPAP were comparable in decreasing respiratory rate, pCO2, and need for oxygen supply.• Pain score during therapy was lower in the HFNC group.",2020,Mean baseline pCO2 was 6.7 in both groups and mean respiratory rate was 60 vs 56 in the CPAP and HFNC group respectively.,"['viral bronchiolitis', 'infants with bronchiolitis for decades', '50 children with bronchiolitis', 'young children with bronchiolitis, treated with CPAP or HFNC']","['high flow nasal cannula (HFNC) therapy', 'CPAP or HFNC', 'High flow nasal cannula and continuous positive airway pressure therapy', 'HFNC', 'Continuous positive airway pressure (CPAP']","['treatment duration or length of hospitalization', 'respiratory rate, pCO2, and Modified Woods Clinical Asthma Score (M-WCAS', 'Pain score', 'mean respiratory rate', 'NIPS', 'Mean baseline pCO2', 'Neonatal Infant Pain Score (NIPS), treatment duration, treatment failure, and hospitalization length', 'respiratory rate, pCO2, and need for oxygen supply.•', 'development of respiratory rate, pCO2, or M-WCAS']","[{'cui': 'C0006274', 'cui_str': 'Bronchiolitis, Viral'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0391839', 'cui_str': 'PCO2'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0043217', 'cui_str': 'Wood'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0162643'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0243107', 'cui_str': 'development'}]",50.0,0.105608,Mean baseline pCO2 was 6.7 in both groups and mean respiratory rate was 60 vs 56 in the CPAP and HFNC group respectively.,"[{'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Vahlkvist', 'Affiliation': 'Department of Pediatric and Adolecent Medicine, Hospital South West Jutland, Finsensgade 35, Esbjerg, 6700, Denmark. Signe.Vahlkvist@rsyd.dk.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Jürgensen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Hospital of Lillebaelt, Sygehusvej 24, Kolding, 6000, Denmark.'}, {'ForeName': 'Amalie', 'Initials': 'A', 'LastName': 'la Cour', 'Affiliation': 'Department of Pediatric and Adolecent Medicine, Hospital South West Jutland, Finsensgade 35, Esbjerg, 6700, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Markoew', 'Affiliation': 'Department of Pediatric and Adolecent Medicine, Hospital South West Jutland, Finsensgade 35, Esbjerg, 6700, Denmark.'}, {'ForeName': 'Thomas Houmann', 'Initials': 'TH', 'LastName': 'Petersen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Hospital of Lillebaelt, Sygehusvej 24, Kolding, 6000, Denmark.'}, {'ForeName': 'Poul-Erik', 'Initials': 'PE', 'LastName': 'Kofoed', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, Hospital of Lillebaelt, Sygehusvej 24, Kolding, 6000, Denmark.'}]",European journal of pediatrics,['10.1007/s00431-019-03533-2']
3278,32164886,Effects of Liraglutide on Cardiovascular Outcomes in Patients With Diabetes With or Without Heart Failure.,"BACKGROUND
More data regarding effects of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes (T2D) and heart failure (HF) are required.
OBJECTIVES
The purpose of this study was to investigate the effects of liraglutide on cardiovascular events and mortality in LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results) participants, by HF history.
METHODS
In the multinational, double-blind, randomized LEADER trial, 9,340 patients with T2D and high cardiovascular risk were assigned 1:1 to liraglutide (1.8 mg daily or maximum tolerated dose up to 1.8 mg daily) or placebo plus standard care, and followed for 3.5 to 5 years. New York Heart Association (NYHA) functional class IV HF was an exclusion criterion. The primary composite major adverse cardiovascular events outcome was time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Post hoc Cox regression analyses of outcomes by baseline HF history were conducted.
RESULTS
At baseline, 18% of patients had a history of NYHA functional class I to III HF (liraglutide: n = 835 of 4,668; placebo: n = 832 of 4,672). Effects of liraglutide versus placebo on major adverse cardiovascular events were consistent in patients with (hazard ratio [HR]: 0.81 [95% confidence interval (CI): 0.65 to 1.02]) and without (HR: 0.88 [95% CI: 0.78 to 1.00]) a history of HF (p interaction = 0.53). In both subgroups, fewer deaths were observed with liraglutide (HR: 0.89 [95% CI: 0.70 to 1.14] with HF; HR: 0.83 [95% CI: 0.70 to 0.97] without HF; p interaction = 0.63) versus placebo. No increased risk of HF hospitalization was observed with liraglutide, regardless of HF history (HR: 0.98 [95% CI: 0.75 to 1.28] with HF; HR: 0.78 [95% CI: 0.61 to 1.00] without HF; p interaction = 0.22). Effects of liraglutide on the composite of HF hospitalization or cardiovascular death were consistent in patients with (HR: 0.92 [95% CI: 0.74 to 1.15]) and without (HR: 0.77 [95% CI: 0.65 to 0.91]) a history of HF (p interaction = 0.19).
CONCLUSIONS
Based on these findings, liraglutide should be considered suitable for patients with T2D with or without a history of NYHA functional class I to III HF. (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results [LEADER]; NCT01179048).",2020,"In both subgroups, fewer deaths were observed with liraglutide (HR: 0.89 [95% CI: 0.70 to 1.14] with HF; HR: 0.83","['Diabetes: Evaluation of Cardiovascular Outcome Results) participants, by HF history', 'patients with T2D with or without a history of NYHA functional class I to III HF', 'patients with type 2 diabetes (T2D) and heart failure (HF', 'Diabetes', 'Patients With Diabetes With or Without Heart\xa0Failure', 'n\xa0=\xa0832 of 4,672', '9,340 patients with T2D and high cardiovascular risk']","['Liraglutide', 'III HF (liraglutide: n\xa0', 'New York Heart Association (NYHA', 'placebo', 'liraglutide', 'glucagon-like peptide-1 receptor agonists']","['adverse cardiovascular events outcome was time to first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke', 'composite of HF hospitalization or cardiovascular death', 'history of NYHA functional class', 'Cardiovascular\xa0Outcomes', 'risk of HF hospitalization', 'deaths', 'major adverse cardiovascular events']","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",9340.0,0.173983,"In both subgroups, fewer deaths were observed with liraglutide (HR: 0.89 [95% CI: 0.70 to 1.14] with HF; HR: 0.83","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Marso', 'Affiliation': 'Midwest Heart and Vascular Institute, HCA Midwest Health, Overland Park, Kansas. Electronic address: Steve.Marso@HCAHealthcare.com.'}, {'ForeName': 'Florian M M', 'Initials': 'FMM', 'LastName': 'Baeres', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Swansea University Medical School, Swansea, Wales, United Kingdom.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Ted Rogers Centre for Heart Research, Toronto General Hospital Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St. Josef-Hospital (Ruhr University), Bochum, Germany.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'Faculty of Medicine, School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, Florida.'}, {'ForeName': 'Anne Bloch', 'Initials': 'AB', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.12.063']
3279,31883845,Short-term transcriptional response to IL-17 receptor-A antagonism in the treatment of psoriasis.,"BACKGROUND
IL-17 antagonists induce impressive clinical benefits in psoriasis, but it is unknown to what extent cellular and molecular psoriasis characteristics are suppressed by a clinically relevant dose/schedule of any IL-17-receptor antagonist.
OBJECTIVE
We sought to examine the effects of the IL-17 receptor-A antagonist brodalumab, on clinical and molecular psoriasis features over a 12-week period.
METHODS
A subset of patients (n = 116) enrolled in 3 phase-3 randomized clinical trials (AMAGINE -1 [Efficacy, Safety, and Withdrawal and Retreatment With Brodalumab in Moderate to Severe Plaque Psoriasis Subjects], -2 [P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis], and -3 [Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis in Subjects]) participated in a mechanistic substudy where punch biopsies were collected (lesional and nonlesional skin) between baseline and 12 weeks. This cohort included moderate-to-severe psoriasis patients treated with 140 mg (n = 46), 210 mg (n = 41) brodalumab, or placebo (n = 29). Key epidermal psoriatic features, including T-cell and dendritic cell subsets, were examined using immunohistochemistry. Treatment-induced changes in lesional skin gene expression profiles were evaluated using Affymetrix arrays.
RESULTS
IL-17 receptor-A antagonism caused extensive improvements in clinical, histologic, and transcriptomic features of psoriasis. Cellular infiltrates (CD3+, CD8+, CD11c+, CD163+), markers of keratinocyte proliferation (Ki67+, KRT16), and inflammatory cytokines (IL-17A/C/F, IL-23A, IL-12B) decreased progressively, reaching close to nonlesional levels, paralleled by decreases in epidermal thickness. Psoriasis transcriptome gene expression improved ∼85% to 95% in responders whose psoriasis area severity index improved by 75% from baseline by week 12 (n = 63), compared with ∼30% to 65% in nonresponders (n = 12), while the residual disease genomic profile was 10% of the psoriasis transcriptome, which is less than for earlier generation drugs. IL-17-dependent gene expression, including keratinocyte genes, improved earlier and more extensively following brodalumab treatment compared with ustekinumab treatment (anti-IL-23/-IL-12).
CONCLUSIONS
The clinically approved dose and schedule for brodalumab leads to nearly complete resolution of clinical, histologic, and transcriptomic features of psoriasis. Evidently, IL-17-induced release of keratinocyte-derived inflammatory mediators is a key driver of psoriasis pathogenesis.",2020,"IL-17-dependent gene expression, including keratinocyte genes, improved earlier and more extensively following brodalumab treatment compared with ustekinumab (anti-IL-23/IL-12).
","['moderate-to-severe psoriasis patients treated with 140mg (n=46), 210mg (n=41', 'Psoriasis', 'A subset of patients (n=116) enrolled in three Phase-3 randomized clinical trials (AMAGINE-1,2,3) participated in a mechanistic sub-study where punch biopsies were collected (lesional and non-lesional skin) between baseline and 12-weeks']","['brodalumab or placebo', 'IL-17 Receptor-A antagonism', 'IL-17-receptor-A antagonist brodalumab']","['Psoriasis transcriptome gene expression', 'residual disease genomic profile', 'epidermal thickness', 'Cellular infiltrates (CD3+, CD8+, CD11c+, CD163+), markers of keratinocyte proliferation (Ki67+, KRT16) and inflammatory cytokines (IL-17A/C/F, IL-23A, IL-12B', 'lesional skin gene expression profiles']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184924', 'cui_str': 'Punch biopsy (procedure)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3491331', 'cui_str': 'brodalumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1721056', 'cui_str': 'IL-17 Receptors'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C3178810', 'cui_str': 'Transcriptome'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte (cell)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}]",,0.0798895,"IL-17-dependent gene expression, including keratinocyte genes, improved earlier and more extensively following brodalumab treatment compared with ustekinumab (anti-IL-23/IL-12).
","[{'ForeName': 'Lewis E', 'Initials': 'LE', 'LastName': 'Tomalin', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Chris B', 'Initials': 'CB', 'LastName': 'Russell', 'Affiliation': 'BioMarin Pharmaceutical Inc, Novato, Calif.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Garcet', 'Affiliation': 'The Rockefeller University, New York, NY.'}, {'ForeName': 'David Adrian', 'Initials': 'DA', 'LastName': 'Ewald', 'Affiliation': 'Leo Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klekotka', 'Affiliation': 'Lilly Biotechnology Center, San Diego, Calif.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nirula', 'Affiliation': 'Lilly Biotechnology Center, San Diego, Calif.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Norsgaard', 'Affiliation': 'Leo Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Suàrez-Fariñas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: Mayte.SuarezFarinas@mssm.edu.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'The Rockefeller University, New York, NY. Electronic address: kruegej@mail.rockefeller.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.10.041']
3280,31554943,Effect of multiple subconjunctival conbercept injections as an adjuvant to the surgical treatment of pterygium: a prospective randomised comparative 6-month follow-up study.,"OBJECTIVE
To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery.
METHODS
As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out.
RESULTS
There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078).
CONCLUSION
Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.",2020,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","['pterygium', '96 eyes from 96 patients with a tendency to recur', 'pterygium patients after surgery']","['5-Fu', 'multiple subconjunctival conbercept injections', 'conbercept and 5-fluorouracil', 'multiple subconjunctival injections of conbercept', 'subconjunctival injections of conbercept (0.2\u2009ml) or 5-fluorouracil']","['corneal abrasions', 'pterygium morphology, colour intensity, recurrence, and complications', 'subconjunctival haemorrhage', 'persistent epithelial defects', 'safe, effective, and well-tolerated', 'recurrence', 'pterygium morphology', 'safety and efficacy']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0010032', 'cui_str': 'Corneal abrasion (disorder)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0163744,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Quanxi', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Donglai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Honghu, No 142. Xinjian Road, 433202, Honghu, Hubei, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China. keminyk@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0596-7']
3281,30761976,The CORE service improvement programme for mental health crisis resolution teams: results from a cluster-randomised trial.,"BACKGROUND
Crisis resolution teams (CRTs) offer brief, intensive home treatment for people experiencing mental health crisis. CRT implementation is highly variable; positive trial outcomes have not been reproduced in scaled-up CRT care.
AIMS
To evaluate a 1-year programme to improve CRTs' model fidelity in a non-masked, cluster-randomised trial (part of the Crisis team Optimisation and RElapse prevention (CORE) research programme, trial registration number: ISRCTN47185233).
METHOD
Fifteen CRTs in England received an intervention, informed by the US Implementing Evidence-Based Practice project, involving support from a CRT facilitator, online implementation resources and regular team fidelity reviews. Ten control CRTs received no additional support. The primary outcome was patient satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8), completed by 15 patients per team at CRT discharge (n = 375). Secondary outcomes: CRT model fidelity, continuity of care, staff well-being, in-patient admissions and bed use and CRT readmissions were also evaluated.
RESULTS
All CRTs were retained in the trial. Median follow-up CSQ-8 score was 28 in each group: the adjusted average in the intervention group was higher than in the control group by 0.97 (95% CI -1.02 to 2.97) but this was not significant (P = 0.34). There were fewer in-patient admissions, lower in-patient bed use and better staff psychological health in intervention teams. Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up. There were no significant effects for other outcomes.
CONCLUSIONS
The CRT service improvement programme did not achieve its primary aim of improving patient satisfaction. It showed some promise in improving CRT model fidelity and reducing acute in-patient admissions.",2020,Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up.,['people experiencing mental health crisis'],[],"['CRT model fidelity, continuity of care, staff well-being, in-patient admissions and bed use and CRT readmissions', 'Model fidelity', 'patient satisfaction, measured by the Client Satisfaction Questionnaire (CSQ-8', 'Median follow-up CSQ-8 score', 'CRT model fidelity', 'patient satisfaction', 'patient admissions, lower in-patient bed use and better staff psychological health']","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}]",[],"[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0030673', 'cui_str': 'Patient Admission'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",375.0,0.271692,Model fidelity rose in most intervention teams and was significantly higher than in control teams at follow-up.,"[{'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Senior Lecturer, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osborn', 'Affiliation': 'Professor of Psychiatric Epidemiology, Division of Psychiatry, University College London; and St Pancras Hospital, Camden and Islington NHS Foundation Trust, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marston', 'Affiliation': 'Principal Research Associate, Department of Primary Care and Population Health, UCL Medical School (Royal Free Campus); and Priment Clinical Trials Unit, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lamb', 'Affiliation': 'Research Associate, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Ambler', 'Affiliation': 'Associate Professor in Medical Statistics, Department of Statistical Science, UCL, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Hunter', 'Affiliation': 'Senior Research Associate, Department of Primary Care and Population Health, UCL Medical School (Royal Free Campus); and Priment Clinical Trials Unit, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Mason', 'Affiliation': 'Reader in Clinical Psychology, School of Psychology, University of Surrey, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Research Fellow, Epidemiology and Health Services Research, CLAHRC West, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Henderson', 'Affiliation': 'Clinical Senior Lecturer, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Onyett', 'Affiliation': 'previously Chief Executive, Onyett Entero, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Johnston', 'Affiliation': 'Principal Research Associate, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Morant', 'Affiliation': 'Associate Professor, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Nolan', 'Affiliation': 'Professor of Nursing, School of Health and Human Sciences, University of Essex, UK.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'Consultant Psychiatrist, Barnes Unit, John Radcliffe Hospital, Oxford Health NHS Foundation Trust, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Christoforou', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Fullarton', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Forsyth', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Piotrowski', 'Affiliation': 'Research Assistant, Avon and Wiltshire Mental Health Partnership NHS Trust, Research & Development Office, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Mundy', 'Affiliation': 'Research Assistant, Division of Psychiatry, University College London, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Bond', 'Affiliation': 'Professor of Psychiatry, Westat, Rivermill Commercial Center, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Professor of Social and Community Psychiatry, Division of Psychiatry, University College London; and St Pancras Hospital, Camden and Islington NHS Foundation Trust, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2019.21']
3282,31055663,New insights into the natural course and clinical relevance of Modic changes over 2 years following lumbar limited discectomy: analysis of prospective collected data.,"PURPOSE
Few retrospective studies have addressed Modic changes (MC) following lumbar spine surgery, though it is usually assumed that MC increase in grade and incidence. To test this conventional wisdom, we investigated the natural course of MC following primary lumbar limited discectomy with two-year follow-up. In addition, a possible clinical relevance to those changes was assessed.
METHODS
The data of the control group (278 subjects) of a prospective randomized, controlled trial (RCT) were evaluated retrospectively.
RESULTS
We did not observe a simple increase in MC with regard to grade. There is variable activity observed in Type 2 (at 12 months) and in Type 1 (at 24 months). Conversion from one grade to another may occur and may be upward or downward. The incidence of MC increased slightly over time, as after surgery a decreasing percentage of the study group remained without MC over two years (1 year: 34% (85/250); 2 years: 30% (72/237)). Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes. Lastly, we found that neither the different MC types nor their changes were correlated with clinical parameters (VAS back, VAS leg, ODI score) preoperatively or during follow-up.
CONCLUSION
The pattern of Modic changes following lumbar limited discectomy is complex, not simply increasing. There is variable activity in MC Types 1 and 2 at the different time points of follow-up, and conversion from a higher grader to a lower one or vice versa is possible. These slides can be retrieved under Electronic Supplementary Material.",2019,"Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes.",[],[],"['incidence of MC', 'clinical parameters (VAS back, VAS leg, ODI score', 'Radiological parameters (rotation, translation, and spondylolisthesis']",[],[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0038016', 'cui_str': 'Spondylisthesis'}]",,0.0423849,"Radiological parameters (rotation, translation, and spondylolisthesis) had no significant correlation to MC or MC subtypes.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bostelmann', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany. richard.bostelmann@med.uni-duesseldorf.de.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Petridis', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany.'}, {'ForeName': 'Katinka', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Mathematical Institute, Heinrich Heine University, Duesseldorf, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vajkoczy', 'Affiliation': 'Department of Neurosurgery, Charité Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Bostelmann', 'Affiliation': 'Department of Neurosurgery, Medical Faculty, University Hospital Duesseldorf, Moorenstrasse 5, 40225, Duesseldorf, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Barth', 'Affiliation': 'Department of Neurosurgery, Klinikum Frankfurt Höchst, Frankfurt, Germany.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05988-1']
3283,31498937,"Effects of a 12-Month Supervised, Community-Based, Multimodal Exercise Program Followed by a 6-Month Research-to-Practice Transition on Bone Mineral Density, Trabecular Microarchitecture, and Physical Function in Older Adults: A Randomized Controlled Trial.","Multicomponent exercise programs are recommended to reduce fracture risk; however, their effectiveness in real-world community settings remain uncertain. This 18-month randomized controlled trial investigated the effects of a 12-month, community-based, supervised multicomponent exercise program followed by a 6-month ""research-to-practice"" transition on areal bone mineral density (BMD), trabecular bone microarchitecture, functional performance, and falls in older adults at increased fracture risk. One-hundred and sixty-two adults aged ≥60 years with osteopenia or at increased falls risk were randomized to the Osteo-cise: Strong Bones for Life multicomponent exercise program (n = 81) or a control group (n = 81). Exercise consisted of progressive resistance, weight-bearing impact, and balance training (3-days/week) performed at community leisure centers. Overall 148 (91%) participants completed the trial, and mean exercise adherence was 59% after 12 months and 45% during the final 6 months. After 12 months, there were significant net beneficial effects of exercise on lumbar spine and femoral neck BMD (1.0% to 1.1%, p < 0.05), muscle strength (10% to 13%, p < 0.05), and physical function (timed stair climb 5%; four-square step test 6%; sit-to-stand 16%, p ranging <0.05 to <0.001), which persisted after the 6-month transition. There were no significant effects of the 18-month intervention on distal femur or proximal tibia trabecular bone microarchitecture or falls incidence, but per protocol analysis (≥66% exercise adherence) revealed there was a significant net benefit of exercise (mean [95% confidence interval] 2.8% [0.2, 5,4]) on proximal tibia trabecular bone volume fraction (Osteo-cise 1.5% [-1.2, 4.2]; controls -1.3% [-2.6, 0.1]) after 18 months due to changes in trabecular number (Osteo-cise 1.7% [-0.9, 4.3]; controls -1.1% [-2.4, 0.2]) but not trabecular thickness (Osteo-cise - 0.2% [-0.5, 0.2]; controls -0.2% [-0.4, 0.0]). In conclusion, this study supports the effectiveness of the Osteo-cise: Strong Bones for Life program as a real-world, pragmatic, evidence-based community exercise program to improve multiple musculoskeletal health outcomes in older adults at increased fracture risk. © 2019 American Society for Bone and Mineral Research.",2020,"There were no significant effects of the 18-month intervention on distal femur or proximal tibia trabecular bone microarchitecture or falls incidence, but per protocol analysis (≥66% exercise adherence) revealed there was a significant net benefit of exercise [mean (95% confidence interval): 2.8% (0.2, 5,4)] on proximal tibia trabecular bone volume fraction [Osteo-cise 1.5% (-1.2, 4.2); controls -1.3% (-2.6, 0.1)] after 18-months, due to changes in trabecular number [Osteo-cise 1.7% (-0.9, 4.3); controls -1.1% (-2.4, 0.2)] and not trabecular thickness [Osteo-cise -0.2% (-0.5, 0.2); controls -0.2% (-0.4, 0.0)].","['older adults', 'older adults at increased fracture risk', 'One-hundred and sixty-two adults aged ≥60\u2009years with osteopenia or at increased falls risk']","['Multi-component exercise programs', 'Osteo-cise: Strong Bones for Life multi-component exercise program', 'community-based, supervised multi-component exercise program', 'supervised, community-based, multi-modal exercise program', 'Exercise consisted of progressive resistance, weight-bearing impact and balance training (3-days/week) performed at community leisure centres']","['trabecular thickness', 'mean exercise adherence', 'physical function', 'lumbar spine and femoral neck BMD', 'proximal tibia trabecular bone volume fraction', 'muscle strength', 'distal femur or proximal tibia trabecular bone microarchitecture or falls incidence']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0557790', 'cui_str': 'Leisure center (environment)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0588198', 'cui_str': 'Bone structure of proximal tibia (body structure)'}, {'cui': 'C0222660', 'cui_str': 'Spongy Bone'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",162.0,0.0664968,"There were no significant effects of the 18-month intervention on distal femur or proximal tibia trabecular bone microarchitecture or falls incidence, but per protocol analysis (≥66% exercise adherence) revealed there was a significant net benefit of exercise [mean (95% confidence interval): 2.8% (0.2, 5,4)] on proximal tibia trabecular bone volume fraction [Osteo-cise 1.5% (-1.2, 4.2); controls -1.3% (-2.6, 0.1)] after 18-months, due to changes in trabecular number [Osteo-cise 1.7% (-0.9, 4.3); controls -1.1% (-2.4, 0.2)] and not trabecular thickness [Osteo-cise -0.2% (-0.5, 0.2); controls -0.2% (-0.4, 0.0)].","[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Mariana E', 'Initials': 'ME', 'LastName': 'Kersh', 'Affiliation': 'Department of Mechanical Science and Engineering, University of Illinois at Urbana-Champaign, Urbana, IL, USA.'}, {'ForeName': 'Christine A', 'Initials': 'CA', 'LastName': 'Bailey', 'Affiliation': 'Department of Medicine, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Krug', 'Affiliation': 'Department of Radiology and Biomedical Imaging, School of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Caryl A', 'Initials': 'CA', 'LastName': 'Nowson', 'Affiliation': 'Institute for Physical Activity and Nutrition Research, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Kerrie M', 'Initials': 'KM', 'LastName': 'Sanders', 'Affiliation': 'Department of Medicine, The University of Melbourne, Melbourne, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.3865']
3284,32067262,"First-in-human study with ACT-539313, a novel selective orexin-1 receptor antagonist.","AIMS
The orexin system is involved in anxiety behaviour and corresponding physiological reactions and constitutes a target for treatment of anxiety disorders. ACT-539313 is a potent, selective orexin-1 receptor antagonist being developed for the treatment of anxiety disorders. This first-in-human study investigated its single-dose pharmacokinetics (PK) including food effect, pharmacodynamics (PD), safety and tolerability.
METHODS
This double-blind, placebo-controlled, randomized study included 40 healthy male subjects. Ascending oral doses of 10-400 mg ACT-539313 were investigated in 5 dose groups of 8 subjects (of whom 2 received placebo per dose group). At 100 mg, subjects received ACT-539313 in fasted and fed conditions in a fixed sequential design. PK, PD (objective and subjective measures of sedation and effects on central nervous system), safety and tolerability were assessed.
RESULTS
In fasted conditions, ACT-539313 was rapidly absorbed (median time to maximum plasma concentration [C max ] 0.7-3.5 h) and cleared from plasma with a mean terminal half-life of 3.3-5.7 h across dose levels. A 1.63-fold (90% confidence interval: 1.26-2.11) increase in C max and no change in area under the concentration-time curve extrapolated to infinity was observed under fed compared to fasted conditions. No relevant PD signals were detected except for a trend of reduced saccadic peak velocity around time to C max . The most commonly reported adverse events were somnolence and headache. All adverse events were transient and of mild or moderate intensity. No treatment-related effects on vital signs, clinical laboratory or 12-lead electrocardiogram were observed.
CONCLUSIONS
ACT-539313 exhibits good safety and tolerability at single doses of up to and including 400 mg that warrant further investigations.",2020,"No treatment-related effects on vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG) were observed.
",['40 healthy male subjects'],"['placebo', 'ACT-539313']","['food effect, pharmacodynamics (PD), safety, and tolerability', 'somnolence and headache', 'vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG', 'saccadic peak velocity', 'C max and no change in AUC 0-inf', 'safety and tolerability', 'PK, PD (objective and subjective measures of sedation and effects on central nervous system), safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0518766'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]",40.0,0.258047,"No treatment-related effects on vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG) were observed.
","[{'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ort', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Kornberger', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14251']
3285,31087164,Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy: a new guidance method that reduces radiation doses.,"PURPOSE
The purpose of this study is to establish a new method to reduce the radiation dose during puncture and cannulation in percutaneous endoscopic lumbar discectomy (PELD).
METHODS
Sixty patients with lumbar disk herniation undergoing PELD were prospectively enrolled and randomly divided into an ultrasound (US) guidance group and an X-ray guidance group. The puncture, cannulation, and total operation times; number of fluoroscopy shots; and radiation dose were recorded in both groups. The factors influencing the operation were analyzed. The clinical effect of PELD was evaluated using the straight leg elevation test, visual analog scale (VAS) and Oswestry disability index (ODI). The researchers who collected and analyzed the data were blinded to the group assignments.
RESULTS
The puncture, cannulation and operation times in the US group were comparable to those in the X-ray group. The patients in the US group received 2.13 ± 0.35 fluoroscopy shots and a radiation dose of 5.34 ± 0.63 (mSV), which were significantly lower than the values in the X-ray group (7.57 shots ± 2.99 shots and 18.25 mSV ± 10.52 mSV) (P < 0.001). In the US group, the puncture time was significantly longer at the L5-S1 level, in patients with a BMI greater than 28 kg/m 2 and in patients with a high iliac crest. The US and X-ray groups had comparable VAS and ODI scores 1 h and 3 months after PELD, and the VAS scores were significantly lower after PELD (all P < 0.001). No complications were observed in either group.
CONCLUSIONS
US guidance is a new method that reduces the radiation dose required during puncture and cannulation in PELD. These slides can be retrieved under Electronic Supplementary Material.",2019,The US and X-ray groups had comparable VAS and ODI scores,['Sixty patients with lumbar disk herniation undergoing PELD'],"['ultrasound (US) guidance group and an X-ray guidance group', 'percutaneous endoscopic lumbar discectomy (PELD', 'Ultrasound-guided transforaminal percutaneous endoscopic lumbar discectomy']","['VAS and ODI scores', 'puncture, cannulation, and total operation times; number of fluoroscopy shots; and radiation dose', 'VAS scores', 'puncture time', 'puncture, cannulation and operation times', 'straight leg elevation test, visual analog scale (VAS) and Oswestry disability index (ODI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",60.0,0.0167607,The US and X-ray groups had comparable VAS and ODI scores,"[{'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Longtao', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Pain, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Shoupeng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Ultrasound, General Hospital of Chinese PLA, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedics, General Hospital of Chinese PLA, No. 28, Fuxing Road, Haidian District, Beijing, 100853, China. harryhp@vip.sina.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-05980-9']
3286,31805311,Sustained successful peanut oral immunotherapy associated with low basophil activation and peanut-specific IgE.,"BACKGROUND
Oral immunotherapy (OIT) can successfully desensitize many peanut-allergic subjects, but clinical tolerance diminishes over time on discontinuation, or low-dose maintenance, of peanut. Therefore, to improve the efficacy and sustainability of such therapy, we sought to identify biomarkers and clinical tools that can predict therapeutic outcomes and monitor treatment responses.
OBJECTIVE
We evaluated whether basophil activation in whole blood, and plasma levels of peanut-specific immunoglobulins, are useful biomarkers for peanut OIT.
METHODS
We longitudinally measured, before, during, and after OIT, basophil activation in whole blood ex vivo in response to peanut stimulation, and peanut-specific IgE (sIgE) and peanut-specific IgG 4 (sIgG 4 ), in a large, single-site, double-blind, randomized, placebo-controlled, phase 2 peanut OIT study. We compared basophil responsiveness and peanut-specific immunoglobulins between those who were clinically reactive and those who were tolerant to peanut oral challenges.
RESULTS
Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG 4 /sIgE. Participants who became reactive to 4 g of peanut 13 weeks off active OIT exhibited higher peanut-induced basophil activation ex vivo and higher peanut sIgE levels and sIgE/total IgE, but lower sIgG 4 /sIgE. Notably, participants entering the study with low basophil responsiveness were more likely to achieve treatment success. Substantial suppression of basophil activation was required to maintain long-term clinical tolerance after peanut OIT.
CONCLUSIONS
Assessments of peanut-induced basophil activation and peanut-specific immunoglobulins can help to predict treatment outcomes, and to differentiate transient desensitization versus sustained unresponsiveness after OIT.",2020,"Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG",[],"['placebo', 'Oral immunotherapy (OIT', 'peanut-specific IgE (sIgE) and peanut-specific IgG 4 ']","['basophil activation ex\xa0vivo and higher peanut sIgE levels and sIgE/total IgE, but lower sIgG', 'basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG', 'low basophil activation and peanut-specific IgE']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]","[{'cui': 'C4316898', 'cui_str': 'Basophil, segmented (cell)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0063241', 'cui_str': 'hypoxanthine arabinoside'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1270751', 'cui_str': 'Arachis hypogaea specific immunoglobulin E (substance)'}]",,0.0751136,"Peanut OIT significantly decreased basophil activation, peanut sIgE, Ara h 1, Ara h 2, and Ara h 3 IgE levels, and sIgE/total IgE, but increased sIgG","[{'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Tsai', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Mukai', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'R Sharon', 'Initials': 'RS', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Medicine, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Galli', 'Affiliation': 'Department of Pathology, Stanford University School of Medicine, Stanford, Calif; Sean N. Parker Center for Allergy and Asthma Research, Stanford University School of Medicine, Stanford, Calif; Department of Microbiology and Immunology, Stanford University School of Medicine, Stanford, Calif. Electronic address: sgalli@stanford.edu.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.10.038']
3287,29868449,Enhancing treatment of osteoarthritis knee pain by boosting expectancy: A functional neuroimaging study.,"Objectives
Expectation can significantly modulate pain and treatment effects. This study aims to investigate if boosting patients' expectancy can enhance the treatment of knee osteoarthritis (KOA), and its underlying brain mechanism.
Methods
Seventy-four KOA patients were recruited and randomized to three groups: boosted acupuncture (with a manipulation to enhance expectation), standard acupuncture, or treatment as usual (TAU). Each patient underwent six treatments before being debriefed, and four additional treatments after being debriefed. The fMRI scans were applied during the first and sixth treatment sessions.
Results
We found significantly decreased knee pain in the boosted acupuncture group compared to the standard acupuncture or TAU groups after both six and ten treatments. Resting state functional connectivity (rsFC) analyses using the nucleus accumbens (NAc) as the seed showed rsFC increases between the NAc and the medial prefrontal cortex (MPFC)/rostral anterior cingulate cortex (rACC) and dorsolateral prefrontal cortex in the boosted group as compared to the standard acupuncture group after multiple treatments. Expectancy scores after the first treatment were significantly associated with increased NAc-rACC/MPFC rsFC and decreased knee pain following treatment.
Conclusions
Our study provides a novel method and mechanism for boosting the treatment of pain in patients with KOA. Our findings may shed light on enhancing outcomes of pharmacological and integrative medicines in clinical settings.",2018,We found significantly decreased knee pain in the boosted acupuncture group compared to the standard acupuncture or TAU groups after both six and ten treatments.,"['patients with KOA', 'Seventy-four KOA patients']","['acupuncture', 'acupuncture (with a manipulation to enhance expectation), standard acupuncture, or treatment as usual (TAU']","['medial prefrontal cortex (MPFC)/rostral anterior cingulate cortex (rACC) and dorsolateral prefrontal cortex', 'knee pain', 'Expectancy scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517867', 'cui_str': 'Seventy-four'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",74.0,0.0267453,We found significantly decreased knee pain in the boosted acupuncture group compared to the standard acupuncture or TAU groups after both six and ten treatments.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA, USA; MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, MA, USA. Electronic address: kongj@nmr.mgh.harvard.edu.'}, {'ForeName': 'Zengjian', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Leiser', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Domenic', 'Initials': 'D', 'LastName': 'Minicucci', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative, and Pain Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Kirsch', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA; Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, MA, USA.'}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': 'MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, MA, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Charlestown, MA, USA; MGH/MIT/HMS Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, MA, USA; Program in Placebo Studies, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2018.01.021']
3288,30334166,Objective assessment of surgical skill transfer using non-invasive brain imaging.,"BACKGROUND
Physical and virtual surgical simulators are increasingly being used in training technical surgical skills. However, metrics such as completion time or subjective performance checklists often show poor correlation to transfer of skills into clinical settings. We hypothesize that non-invasive brain imaging can objectively differentiate and classify surgical skill transfer, with higher accuracy than established metrics, for subjects based on motor skill levels.
STUDY DESIGN
18 medical students at University at Buffalo were randomly assigned into control, physical surgical trainer, or virtual trainer groups. Training groups practiced a surgical technical task on respective simulators for 12 consecutive days. To measure skill transfer post-training, all subjects performed the technical task in an ex-vivo environment. Cortical activation was measured using functional near-infrared spectroscopy (fNIRS) in the prefrontal cortex, primary motor cortex, and supplementary motor area, due to their direct impact on motor skill learning.
RESULTS
Classification between simulator trained and untrained subjects based on traditional metrics is poor, where misclassification errors range from 20 to 41%. Conversely, fNIRS metrics can successfully classify physical or virtual trained subjects from untrained subjects with misclassification errors of 2.2% and 8.9%, respectively. More importantly, untrained subjects are successfully classified from physical or virtual simulator trained subjects with misclassification errors of 2.7% and 9.1%, respectively.
CONCLUSION
fNIRS metrics are significantly more accurate than current established metrics in classifying different levels of surgical motor skill transfer. Our approach brings robustness, objectivity, and accuracy in validating the effectiveness of future surgical trainers in translating surgical skills to clinically relevant environments.",2019,"Our approach brings robustness, objectivity, and accuracy in validating the effectiveness of future surgical trainers in translating surgical skills to clinically relevant environments.",['18 medical students at University at Buffalo'],"['surgical skill transfer using non-invasive brain imaging', 'control, physical surgical trainer, or virtual trainer groups']",['Cortical activation'],"[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1739095', 'cui_str': 'Bos bison'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive (qualifier value)'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],18.0,0.0155067,"Our approach brings robustness, objectivity, and accuracy in validating the effectiveness of future surgical trainers in translating surgical skills to clinically relevant environments.","[{'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Nemani', 'Affiliation': 'Rensselaer Polytechnic Institute, 110, 8th Street, Troy, NY, 12180, USA.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Kruger', 'Affiliation': 'Rensselaer Polytechnic Institute, 110, 8th Street, Troy, NY, 12180, USA.'}, {'ForeName': 'Clairice A', 'Initials': 'CA', 'LastName': 'Cooper', 'Affiliation': 'University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, 14228, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Schwaitzberg', 'Affiliation': 'University at Buffalo School of Medicine and Biomedical Sciences, Buffalo, NY, 14228, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Intes', 'Affiliation': 'Rensselaer Polytechnic Institute, 110, 8th Street, Troy, NY, 12180, USA.'}, {'ForeName': 'Suvranu', 'Initials': 'S', 'LastName': 'De', 'Affiliation': 'Rensselaer Polytechnic Institute, 110, 8th Street, Troy, NY, 12180, USA. des@rpi.edu.'}]",Surgical endoscopy,['10.1007/s00464-018-6535-z']
3289,32144973,"Comparison of conservative treatment with and without neural mobilization for patients with low back pain: A prospective, randomized clinical trial.","BACKGROUND
Low back pain (LBP) is a common problem that causes pain, disability, and gait and balance problems. Neurodynamic techniques are used in the treatment of LBP.
OBJECTIVE
The aim of this study was to compare the effects of electrotherapy and neural mobilization on pain, functionality, gait, and balance in patients with LBP.
MATERIALS AND METHODS
A total of 41 patients were randomly assigned to either the neural mobilization group (NMG, n= 20) or electrotherapy group (ETG, n= 21). Assessment tools used were Visual Analogue Scale (VAS) for pain, Oswestry Disability Index (ODI) for functionality, straight leg raise test (SLRT) for neural involvement, and baropedographic platform (Zebris FDM-2TM) for gait and static balance measurements.
RESULTS
Both groups showed a significant decrease in pain and functional disability, while only the NMG group showed a significant increase in SLRT scores (p< 0.05). However, there were no statistically significant pre- to post-treatment changes in gait or static balance parameters in either group (p< 0.05).
CONCLUSION
Neural mobilization was effective in reducing pain and improving functionality and SLRT performance in patients with LBP, but induced no change in gait and static balance parameters. Neural mobilization may be used as self-practice to supplement standard treatment programs.",2020,"However, there were no statistically significant pre- to post-treatment changes in gait or static balance parameters in either group (p< 0.05).
","['41 patients', 'patients with LBP', 'patients with low back pain']","['electrotherapy and neural mobilization', 'neural mobilization group (NMG, n= 20) or electrotherapy', 'conservative treatment with and without neural mobilization', 'Neural mobilization']","['pain, functionality, gait, and balance', 'pain and functional disability', 'SLRT scores', 'pain and improving functionality and SLRT performance', 'Visual Analogue Scale (VAS) for pain, Oswestry Disability Index (ODI) for functionality, straight leg raise test (SLRT) for neural involvement, and baropedographic platform (Zebris FDM-2TM) for gait and static balance measurements', 'gait and static balance parameters', 'gait or static balance parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C1288281', 'cui_str': 'Lasègue test'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",41.0,0.0648156,"However, there were no statistically significant pre- to post-treatment changes in gait or static balance parameters in either group (p< 0.05).
","[{'ForeName': 'Vedat', 'Initials': 'V', 'LastName': 'Kurt', 'Affiliation': 'Deparment of Physiotherapy and Rehabilitation, Faculty of Health Science, Kutahya Health Science University, Kutahya, Turkey.'}, {'ForeName': 'Ozgen', 'Initials': 'O', 'LastName': 'Aras', 'Affiliation': 'Deparment of Physiotherapy and Rehabilitation, Faculty of Health Science, Kutahya Health Science University, Kutahya, Turkey.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'Buker', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181241']
3290,29169877,"Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study.","BACKGROUND
EGFR antibodies have shown promise in patients with advanced non-small-cell lung cancer (NSCLC), particularly with squamous cell histology. We hypothesised that EGFR copy number by fluorescence in-situ hybridisation (FISH) can identify patients most likely to benefit from these drugs combined with chemotherapy and we aimed to explore the activity of cetuximab with chemotherapy in patients with advanced NSCLC who are EGFR FISH-positive.
METHODS
We did this open-label, phase 3 study (SWOG S0819) at 277 sites in the USA and Mexico. We randomly assigned (1:1) eligible patients with treatment-naive stage IV NSCLC to receive paclitaxel (200 mg/m 2 ; every 21 days) plus carboplatin (area under the curve of 6 by modified Calvert formula; every 21 days) or carboplatin plus paclitaxel and bevacizumab (15 mg/kg; every 21 days), either with cetuximab (250 mg/m 2 weekly after loading dose; cetuximab group) or without (control group), stratified by bevacizumab treatment, smoking status, and M-substage using a dynamic-balancing algorithm. Co-primary endpoints were progression-free survival in patients with EGFR FISH-positive cancer and overall survival in the entire study population. We analysed clinical outcomes with the intention-to-treat principle and analysis of safety outcomes included patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov (number NCT00946712).
FINDINGS
Between Aug 13, 2009, and May 30, 2014, we randomly assigned 1313 patients to the control group (n=657; 277 with bevacizumab and 380 without bevacizumab in the intention-to-treat population) or the cetuximab group (n=656; 283 with bevacizumab and 373 without bevacizumab in the intention-to-treat population). EGFR FISH was assessable in 976 patients and 400 patients (41%) were EGFR FISH-positive. The median follow-up for patients last known to be alive was 35·2 months (IQR 22·9-39·9). After 194 progression-free survival events in the cetuximab group and 198 in the control group in the EGFR FISH-positive subpopulation, progression-free survival did not differ between treatment groups (hazard ratio [HR] 0·92, 95% CI 0·75-1·12; p=0·40; median 5·4 months [95% CI 4·5-5·7] vs 4·8 months [3·9-5·5]). After 570 deaths in the cetuximab group and 593 in the control group, overall survival did not differ between the treatment groups in the entire study population (HR 0·93, 95% CI 0·83-1·04; p=0·22; median 10·9 months [95% CI 9·5-12·0] vs 9·2 months [8·7-10·3]). In the prespecified analysis of EGFR FISH-positive subpopulation with squamous cell histology, overall survival was significantly longer in the cetuximab group than in the control group (HR 0·58, 95% CI 0·36-0·86; p=0·0071), although progression-free survival did not differ between treatment groups in this subgroup (0·68, 0·46-1·01; p=0·055). Overall survival and progression-free survival did not differ among patients who were EGFR FISH non-positive with squamous cell histology (HR 1·04, 95% CI 0·78-1·40; p=0·77; and 1·02, 0·77-1·36; p=0·88 respectively) or patients with non-squamous histology regardless of EGFR FISH status (for EGFR FISH-positive 0·88, 0·68-1·14; p=0·34; and 0·99, 0·78-1·27; p=0·96; respectively; and for EGFR FISH non-positive 1·00, 0·85-1·17; p=0·97; and 1·03, 0·88-1·20; p=0·69; respectively). The most common grade 3-4 adverse events were decreased neutrophil count (210 [37%] in the cetuximab group vs 158 [25%] in the control group), decreased leucocyte count (103 [16%] vs 74 [20%]), fatigue (81 [13%] vs 74 [20%]), and acne or rash (52 [8%] vs one [<1%]). 59 (9%) patients in the cetuximab group and 31 (5%) patients in the control group had severe adverse events. Deaths related to treatment occurred in 32 (6%) patients in the cetuximab group and 13 (2%) patients in the control group.
INTERPRETATION
Although this study did not meet its primary endpoints, prespecified subgroup analyses of patients with EGFR FISH-positive squamous-cell carcinoma cancers are encouraging and support continued evaluation of anti-EGFR antibodies in this subpopulation.
FUNDING
National Cancer Institute and Eli Lilly and Company.",2018,Overall survival and progression-free survival did not differ among patients who were EGFR FISH non-positive with squamous cell histology (,"['patients who were EGFR FISH non-positive with squamous cell histology ', 'Between Aug 13, 2009, and May 30, 2014', 'group (n=656; 283 with', '976 patients and 400 patients (41%) were EGFR FISH-positive', 'patients who received at least one dose of study drug', '1313 patients to the control group (n=657; 277 with', 'advanced NSCLC (SWOG S0819', 'patients with advanced NSCLC who are EGFR FISH-positive', 'patients with EGFR FISH-positive squamous-cell carcinoma cancers', 'patients with advanced non-small-cell lung cancer (NSCLC), particularly with squamous cell histology']","['carboplatin', 'Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab', 'bevacizumab and 373 without bevacizumab', 'carboplatin plus paclitaxel and bevacizumab', 'bevacizumab and 380 without bevacizumab', 'cetuximab with chemotherapy', 'paclitaxel', 'cetuximab', 'cetuximab group) or without (control group), stratified by bevacizumab treatment, smoking status, and M-substage using a dynamic-balancing algorithm']","['EGFR FISH', 'EGFR FISH-positive subpopulation, progression-free survival', 'leucocyte count', 'EGFR FISH-positive subpopulation with squamous cell histology, overall survival', 'fatigue', 'progression-free survival', 'neutrophil count', 'survival events', 'severe adverse events', 'Deaths', 'acne or rash', 'overall survival', 'Overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0002045'}]","[{'cui': 'C0016163', 'cui_str': 'Fishes'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count (procedure)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",1313.0,0.213709,Overall survival and progression-free survival did not differ among patients who were EGFR FISH non-positive with squamous cell histology (,"[{'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Yale Cancer Center, Yale School of Medicine, New Haven, CT, USA. Electronic address: roy.herbst@yale.edu.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Redman', 'Affiliation': 'Southwest Oncology Group (SWOG) Statistical Center and Clinical Biostatistics, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute, Carolinas Healthcare System, Charlotte, NC, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Semrad', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Lyudmila', 'Initials': 'L', 'LastName': 'Bazhenova', 'Affiliation': 'Moores Cancer Center, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Masters', 'Affiliation': 'Christiana Care Health Systems, Helen F Graham Cancer Center and Research Institute, Wilmington, DE, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Oettel', 'Affiliation': 'Wisconsin National Cancer Institute Community Oncology Research Program (NCORP), Gundersen Health System, LaCrosse, WI, USA.'}, {'ForeName': 'Perry', 'Initials': 'P', 'LastName': 'Guaglianone', 'Affiliation': 'Heartland Cancer Research NCORP, Cancer Care Specialists of Central Illinois, Decatur, IL, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Michigan Cancer Research Consortium NCORP, St Joseph Mercy Health System, Ann Arbor, MI, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Karnad', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Arnold', 'Affiliation': 'Markey Cancer Center, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Marileila', 'Initials': 'M', 'LastName': 'Varella-Garcia', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Southwest Oncology Group (SWOG) Statistical Center and Clinical Biostatistics, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Mack', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Group Chair's Office, Oregon Health & Science University, Portland, OR, USA.""}, {'ForeName': 'Fred R', 'Initials': 'FR', 'LastName': 'Hirsch', 'Affiliation': 'Department of Medicine, Division of Medical Oncology, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Gandara', 'Affiliation': 'University of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(17)30694-0']
3291,29878825,Telephone-delivered lifestyle support with action planning and motivational interviewing techniques to improve rehabilitation outcomes.,"OBJECTIVE
In this randomized controlled trial, we evaluated the effectiveness of a telephone-delivered intervention based on the Health Action Process Approach (HAPA) after discharge from inpatient rehabilitation to address behavior change, emotional status, and glycemic control in patients with Type 2 diabetes.
DESIGN
In a German rehabilitation center, 249 patients with Type 2 diabetes were separated into randomized groups, either a 12-month telephone follow-up support group or the usual care group. The counselor identified personal target areas and intervention modules and developed with the patient an individualized action plan for the telephone support. To enhance motivational processes, they used motivational interviewing techniques. Counselors called patients monthly to support the implementation of the personal plans into the patients' daily routines and to screen for emotional problems. Assessments measured exercise, diet, medication adherence, psychological variables, body mass index, HbA1c, and cardiovascular risk.
RESULTS
Twelve months after inpatient rehabilitation, the telephone group's rate of physical activity rose by 26% compared with the usual care group's 10%. Patients in the intervention group exhibited greater improvements in terms of their illness burden, psychological well-being, and depression. HbA1c fell in the telephone group but increased in the usual care group (-0.68% vs. 0.12%). The intervention group's cardiovascular risk fell, whereas the usual care group's rose (-0.57 vs. 0.23).
CONCLUSION
A theory-based telephone-delivered follow-up intervention utilizing motivational interviewing techniques and focusing on personalized action planning demonstrated improvements in patients' level of activity and health status 12-months postrehabilitation discharge and may be a beneficial supplement to rehabilitation programs. (PsycINFO Database Record",2018,"Twelve months after inpatient rehabilitation, the telephone group's rate of physical activity rose by 26% compared with the usual care group's 10%.","['patients with Type 2 diabetes', '249 patients with Type 2 diabetes']","['Telephone-delivered lifestyle support with action planning and motivational interviewing techniques', 'telephone-delivered intervention based on the Health Action Process Approach (HAPA', 'telephone follow-up support group or the usual care group']","['cardiovascular risk fell', 'rate of physical activity', 'illness burden, psychological well-being, and depression', 'Assessments measured exercise, diet, medication adherence, psychological variables, body mass index, HbA1c, and cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0162698', 'cui_str': 'Economic Burden of Disease'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",249.0,0.0214822,"Twelve months after inpatient rehabilitation, the telephone group's rate of physical activity rose by 26% compared with the usual care group's 10%.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Döbler', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research, Medical Center-University of Freiburg.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Herbeck Belnap', 'Affiliation': 'Center for Behavioral Health and Smart Technology, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Pollmann', 'Affiliation': 'Niederrhein Clinic.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Farin', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research, Medical Center-University of Freiburg.'}, {'ForeName': 'Heiner', 'Initials': 'H', 'LastName': 'Raspe', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Luebeck.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Mittag', 'Affiliation': 'Section of Health Care Research and Rehabilitation Research, Medical Center-University of Freiburg.'}]",Rehabilitation psychology,['10.1037/rep0000224']
3292,31813384,Effects of high-oleic peanuts within a hypoenergetic diet on inflammatory and oxidative status of overweight men: a randomised controlled trial.,"The consumption of food with MUFA has been associated with improvement of inflammation and oxidative stress in overweight individuals. In the present study, we evaluate the effect of high-oleic peanut intake within a hypoenergetic diet on inflammatory and oxidative status markers in overweight men. Sixty-four overweight men (BMI 26-35 kg/m2, 18-50 years old) participated in this randomised controlled study for 4 weeks, allocated into three groups: control (CT, n 22), conventional peanut (CVP, n 21) and high-oleic peanut (HOP, n 21). They followed a hypoenergetic diet (-250 kcal/d; -1045 kJ/d) with or without 56 g of high-oleic or conventional peanuts. After the intervention, the inflammatory markers did not show significant changes in fasting concentrations or postprandial response among the experimental groups (P > 0·05). The activity of oxidative status markers remained unchanged after the intervention. However, in the CT, malondialdehyde showed lower concentration in comparison with the baseline (P = 0·020) and among the groups (P = 0·002). In the present study, the daily intake of high-oleic peanuts within a hypoenergetic diet did not modify the inflammatory markers and oxidative status in overweight men. More studies are needed to better understand the effect of high-oleic peanut intake on health outcomes.",2020,"After the intervention, the inflammatory markers did not show significant changes in fasting concentrations or postprandial response among the experimental groups (P > 0·05).","['Sixty-four overweight men (BMI 26-35 kg/m2, 18-50 years old', 'overweight men', 'overweight individuals']","['high-oleic peanuts within a hypoenergetic diet', 'control (CT, n 22), conventional peanut (CVP, n 21) and high-oleic peanut (HOP, n 21', 'high-oleic peanut intake']","['activity of oxidative status markers', 'fasting concentrations or postprandial response', 'inflammation and oxidative stress', 'inflammatory and oxidative status', 'inflammatory markers and oxidative status', 'inflammatory and oxidative status markers']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",64.0,0.0475825,"After the intervention, the inflammatory markers did not show significant changes in fasting concentrations or postprandial response among the experimental groups (P > 0·05).","[{'ForeName': 'Ana Paula Silva', 'Initials': 'APS', 'LastName': 'Caldas', 'Affiliation': 'Departament of Nutrition and Health, Universidade Federal de Viçosa, 36570-900Viçosa, MG, Brazil.'}, {'ForeName': 'Raquel Duarte Moreira', 'Initials': 'RDM', 'LastName': 'Alves', 'Affiliation': 'Departament of Nutrition and Health, Universidade Federal de Viçosa, 36570-900Viçosa, MG, Brazil.'}, {'ForeName': 'Helen Hermana Miranda', 'Initials': 'HHM', 'LastName': 'Hermsdorff', 'Affiliation': 'Departament of Nutrition and Health, Universidade Federal de Viçosa, 36570-900Viçosa, MG, Brazil.'}, {'ForeName': 'Leandro Licursi', 'Initials': 'LL', 'LastName': 'de Oliveira', 'Affiliation': 'Department of General Biology, Universidade Federal de Viçosa, 36570-900Viçosa, MG, Brazil.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Bressan', 'Affiliation': 'Departament of Nutrition and Health, Universidade Federal de Viçosa, 36570-900Viçosa, MG, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114519003246']
3293,32060930,Titrating a modified ketogenic diet for patients with McArdle disease: A pilot study.,"Glycogen storage disease type V (GSDV) is a rare inborn error of carbohydrate metabolism. Patients present with exercise intolerance due to blocked glycogen breakdown in skeletal muscle. Introducing alternative fuel substrates, such as ketone bodies (KBs), could potentially alleviate muscle symptoms. This pilot study investigates which of three different modified ketogenic diet regimes is optimal for GSDV-patients to follow in a future large-scale study. Participants were randomised to follow one of three diet regimes for 3 weeks (#1: 65%/15%/20%; #2: 75%/15%/10%, or #3: 80%/15%/5%, fat/protein/carbohydrate). The primary outcome was exercise tolerance assessed by heart rate (HR) changes during constant load cycling. Secondary outcomes included levels of ketosis, and changes in perceived exertion and indirect calorimetry measures during exercise. Ten GSDV-patients were included. Eight completed the study. The other two were excluded. Diet #3 showed the highest average KB level (1.1 mmol/L) vs #2 (0.5 mmol/L) and #1 (0.3 mmol/L). Five patients reported subjective symptom relief, all of whom were on diets #2 and #3. All diet regimes seemed to improve fatty acid oxidation rates and exercise capacity as indicated by a small decrease in HR and perceived exertion. The results of this open-label pilot study show that diets #2 and #3 induce ketosis and improve symptoms and exercise capacity in GSDV-patients. Diet #2 had the highest acceptability score and was superior or equal to diet #3 in all other parameters, except level of ketosis. Based on this, we suggest testing diet #2 in a large-scale, placebo-controlled study in GSDV.",2020,All diet regimes seemed to improve fatty acid oxidation rates and exercise capacity as indicated by a small decrease in HR and perceived exertion.,"['patients with McArdle disease', 'GSDV-patients', 'Ten GSDV-patients were included']","['fat/protein/carbohydrate', 'Titrating a modified ketogenic diet']","['levels of ketosis, and changes in perceived exertion and indirect calorimetry measures during exercise', 'highest acceptability score', 'HR and perceived exertion', 'exercise tolerance assessed by heart rate (HR) changes during constant load cycling', 'subjective symptom relief', 'fatty acid oxidation rates and exercise capacity', 'symptoms and exercise capacity', 'Glycogen storage disease type V (GSDV', 'highest average KB level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017924', 'cui_str': 'Myophosphorylase deficiency'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0017924', 'cui_str': 'Myophosphorylase deficiency'}]",,0.0281232,All diet regimes seemed to improve fatty acid oxidation rates and exercise capacity as indicated by a small decrease in HR and perceived exertion.,"[{'ForeName': 'Nicoline', 'Initials': 'N', 'LastName': 'Løkken', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kit K', 'Initials': 'KK', 'LastName': 'Hansen', 'Affiliation': 'The Institute of Neurology, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Storgaard', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mette C', 'Initials': 'MC', 'LastName': 'Ørngreen', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Quinlivan', 'Affiliation': 'The Institute of Neurology, National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12223']
3294,31381365,Competency-Based Approaches to Community Health: A Randomized Controlled Trial to Reduce Childhood Obesity among Latino Preschool-Aged Children.,"Background: Health behavior change interventions that target childhood obesity in minority populations have led to inconsistent and short-lived results. The purpose of this study was to test a novel intervention that was personalized and family-based in a Latino population to reduce childhood obesity. Methods: Competency-Based Approaches to Community Health (COACH) was a randomized controlled trial. Latino parent - child pairs were recruited from community settings in Nashville, TN. Child eligibility criteria included age 3-5 years and a BMI ≥50th percentile. The intervention included 15 weekly, 90-minute sessions followed by 3 months of twice-monthly health coaching calls. The control group was a twice-monthly school readiness curriculum for 3 months. Sessions were conducted by a health coach in local community centers, with groups of 8-11 parent - child pairs. The primary outcome was child BMI trajectory across 12 months, measured at four times. The intervention's effect was assessed by using a longitudinal, linear mixed-effects growth model, adjusting for child gender, baseline child and parent age, and baseline parent BMI and education. Results: Of the 305 parent - child pairs assessed for eligibility, 117 were randomized (59 intervention, 58 control). Child BMI was available for 91.5% at 1-year follow-up. Mean baseline child age was 4.2 [standard deviation (SD) = 0.8] years, and 53.8% of children were female. Mean baseline child BMI was 18.1 (SD = 2.6) kg/m 2 . After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2 per year (95% confidence interval -0.82 to 0.01; p = 0.05). Conclusions: Over 1-year follow-up, the intervention resulted in slower linear BMI growth for Latino preschool-aged children from poverty.",2019,"After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2 per year (95% confidence interval -0.82 to 0.01; p = 0.05). ","['305 parent - child pairs assessed for eligibility, 117 were randomized (59 intervention, 58 control', 'Latino parent - child pairs were recruited from community settings in Nashville, TN', 'Latino Preschool-Aged Children', 'Latino preschool-aged children from poverty', 'Child eligibility criteria included age 3-5 years and a BMI ≥50th percentile', 'Community Health', 'Mean baseline child age was 4.2 [standard deviation (SD)\u2009=\u20090.8] years, and 53.8% of children were female']",['Methods: Competency-Based Approaches to Community Health (COACH'],"['child BMI trajectory', 'slower linear BMI growth', 'Child BMI', 'Childhood Obesity', 'linear child BMI growth', 'Mean baseline child BMI']","[{'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",117.0,0.0917583,"After adjusting for covariates, the intervention's effect on linear child BMI growth was -0.41 kg/m 2 per year (95% confidence interval -0.82 to 0.01; p = 0.05). ","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Teeters', 'Affiliation': 'Department of Psychology and Neuroscience, University of Colorado Boulder, Boulder, CO.'}, {'ForeName': 'Evan C', 'Initials': 'EC', 'LastName': 'Sommer', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Escarfuller', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Van Wyk', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Duhon', 'Affiliation': 'School of Medicine, Louisiana State University Health Sciences Center New Orleans, New Orleans, LA.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Jacobs School of Medicine and Biomedical Sciences, SUNY at Buffalo, Buffalo, NY.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Marcy', 'Initials': 'M', 'LastName': 'Singer-Gabella', 'Affiliation': 'Department of Teaching and Learning, Vanderbilt University, Nashville, TN.'}]",Childhood obesity (Print),['10.1089/chi.2019.0064']
3295,31519496,Comparing cognitive load levels among family members of the critically ill exposed to electronic decision aids.,"Cognitive load predicts one's ability to process information and learn from decision support interventions. The present study compared intrinsic and extraneous cognitive load levels resulting from exposure to two different electronic decision aids. A convenience sample of ninety-seven surrogate decision makers for critically ill patients were randomly assigned to receive either a single dose of a video-based or avatar-based decision aid. Intrinsic and extraneous cognitive load levels among recipients of the video-based decision support resource were lower than recipients of the avatar-based decision support resource. After controlling for age, the observed differences in intrinsic cognitive load were not significantly different, whereas the observed differences in extraneous cognitive load remained. Extraneous cognitive load is a modifiable factor to consider for future developers of decision support interventions that may determine the efficacy of efforts to support patients and family members with decision making.",2019,Intrinsic and extraneous cognitive load levels among recipients of the video-based decision support resource were lower than recipients of the avatar-based decision support resource.,"['A convenience sample of ninety-seven surrogate decision makers for critically ill patients', 'family members of the critically ill exposed to electronic decision aids']",['video-based or avatar-based decision aid'],['intrinsic cognitive load'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0554244', 'cui_str': 'Maker (occupation)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}]",97.0,0.0338384,Intrinsic and extraneous cognitive load levels among recipients of the video-based decision support resource were lower than recipients of the avatar-based decision support resource.,"[{'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'Pignatiello', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America. Electronic address: gap54@case.edu.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Daly', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Heath', 'Initials': 'H', 'LastName': 'Demaree', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Hickman', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States of America.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.151192']
3296,31614214,Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design.,"The OsteoArthritis and Therapy for Sleep (OATS) study is a population-based randomized controlled trial of cognitive behavioral therapy for insomnia (CBTI) with four innovative methodological aims. These are to: (1) Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3) Test a scalable CBT-I intervention; and (4) Evaluate patient-reported outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness over one year. This paper describes progress towards achieving these aims. The target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system. We employed a two-phase screening via mail survey and telephone follow-up, with a 3-week interval between screens to exclude persons with spontaneous improvement in sleep or pain symptoms. Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC). Blinded outcome assessments (completed online or on mailed paper forms) included primary and secondary sleep and pain outcome measures and quality of life measures. We obtained healthcare utilization from administrative claims data. Intent to treat analyses, including all participants randomized when they scheduled the first telephone session, will be conducted to compare CBT-I and EOC outcomes. The trial will be the largest experimental evaluation of telephone CBT-I to date, and the first to evaluate its cost-effectiveness. Trial registration: ClinicalTrials.gov identifier: NCT02946957.",2019,Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC).,"['co-morbid insomnia and osteoarthritis pain', 'Enroll representative participants across Washington state, including those from medically underserved communities; (2) Enroll persons with persistent insomnia and chronic osteoarthritis (OA) pain; (3', 'target population was persons age 60+ who had received OA care within the Kaiser Permanente Washington (KPW) health care system']","['6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC', 'Telephone interventions', 'cognitive behavioral therapy']","['primary and secondary sleep and pain outcome measures and quality of life measures', 'sleep or pain symptoms', 'outcomes (insomnia, pain severity, fatigue, depression) and cost-effectiveness']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0393758', 'cui_str': 'Persistent insomnia (disorder)'}, {'cui': 'C0263778', 'cui_str': 'Chronic osteoarthritis (disorder)'}, {'cui': 'C0039309', 'cui_str': 'Target Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0977968,Participants were randomized to a 6-session telephone-delivered CBT-I intervention or a 6-session telephone education only control condition (EOC).,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'McCurry', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America. Electronic address: smccurry@uw.edu.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Von Korff', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Morin', 'Affiliation': 'Department of Psychology, Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Cunningham', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Pike', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, WA, United States of America.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Thakral', 'Affiliation': 'Department of Nursing, University of Massachusetts Boston, Boston, MA, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wellman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Yeung', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States of America.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Vitiello', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Washington School of Medicine, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.105851']
3297,32078090,"Dose-dependent heart rate responses to drinking water: a randomized crossover study in young, non-obese males.","PURPOSE
The aim of the study was to explore a potential dose effect of water on heart rate responses and markers of vagal tone modulation.
METHODS
This was a randomized crossover study involving eight men whose heart rate and heart rate variability parameters were continuously measured following ingestion of different volumes of still mineral water (200, 400, 600, and 800 mL).
RESULTS
A significant volume by time effect for heart rate (p < 0.005) was observed. Ingestion of all volumes of drink water of more 200 mL significantly decreased the heart rate. Significant time effects for heart rate variability parameters were observed.
CONCLUSION
Ingestion of a mineral water drink affected the heart rate in men in a time-dependent manner, possibly by changes in cardiac vagal modulation.",2020,Ingestion of all volumes of drink water of more 200 mL significantly decreased the heart rate.,"['young, non-obese males']",['mineral water drink'],"['heart rate and heart rate variability parameters', 'heart rate', 'heart rate variability parameters', 'heart rate responses']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1997337', 'cui_str': 'Speed of heart rate response'}]",8.0,0.0442475,Ingestion of all volumes of drink water of more 200 mL significantly decreased the heart rate.,"[{'ForeName': 'Erik Konrad', 'Initials': 'EK', 'LastName': 'Grasser', 'Affiliation': 'Department of Endocrinology, Metabolism, and Cardiovascular System, Laboratory of Integrative Cardiovascular Physiology, University of Fribourg, 1700, Fribourg, Switzerland. erikkonrad.grasser@unifr.ch.'}]",Clinical autonomic research : official journal of the Clinical Autonomic Research Society,['10.1007/s10286-020-00673-6']
3298,31846067,Randomized clinical trial of intracorporeal versus extracorporeal anastomosis in laparoscopic right colectomy (IEA trial).,"BACKGROUND
Several non-randomized and retrospective studies have suggested that intracorporeal anastomosis (IA) has advantages over extracorporeal anastomosis (EA) in laparoscopic right colectomy, but scientific evidence is lacking. The aim was to compare short-term outcomes and to define the possible benefits of IA compared with EA in elective laparoscopic right colectomy.
METHODS
An RCT was conducted from May 2015 to June 2018. The primary endpoint was duration of hospital stay. Secondary endpoints were intraoperative technical events and postoperative clinical outcomes.
RESULTS
A total of 140 patients were randomized. Duration of surgery was longer for procedures with an IA than in those with an EA (median 149 (range 95-215) versus 123 (60-240) min; P < 0·001). Wound length was shorter in the IA group (median 6·7 (4-9·5) versus 8·7 (5-13) cm; P < 0·001). Digestive function recovered earlier in patients with an IA (median 2·3 versus 3·3 days; P = 0·003) and the incidence of paralytic ileus was lower (13 versus 30 per cent; P = 0·022). Less postoperative analgesia was needed in the IA group (mean(s.d.) weighted analgesia requirement 39(24) versus 53(26); P = 0·001) and the pain score was also lower (P = 0·035). The postoperative decrease in haemoglobin level was smaller (mean(s.d.) 8·8(1·7) versus 17·1(1·7) mg/dl; P = 0·001) and there was less lower gastrointestinal bleeding (3 versus 14 per cent; P = 0·031) in the IA group. IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively). The duration of hospital stay was slightly shorter in the IA group (median 5·7 (range 2-19) versus 6·6 (2-23) days; P = 0·194).
CONCLUSION
Duration of hospital stay was similar, but IA was associated with less pain and fewer complications. Registration number: NCT02667860 ( http://www.clinicaltrials.gov).",2020,IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively).,"['elective laparoscopic right colectomy', '140 patients were randomized']","['extracorporeal anastomosis (EA', 'intracorporeal anastomosis (IA', 'EA', '17·1(1·7) mg/dl', 'intracorporeal versus extracorporeal anastomosis']","['haemoglobin level', 'pain score', 'Wound length', 'gastrointestinal bleeding', 'pain and fewer complications', 'postoperative analgesia', 'rate of grade I and II complications', 'Digestive function', 'duration of hospital stay', 'hospital stay', 'incidence of paralytic ileus', 'intraoperative technical events and postoperative clinical outcomes', 'Duration of surgery']","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0192861', 'cui_str': 'Right colectomy (procedure)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030446', 'cui_str': 'Paralytic Ileus'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",140.0,0.370699,IA was associated with a significantly better rate of grade I and II complications (P = 0·016 and P = 0·037 respectively).,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bollo', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Turrado', 'Affiliation': 'Department of Surgery, Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rabal', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Carrillo', 'Affiliation': ""Department of Medicine, Hospital Vall d'Hebron, Autonomous University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Gich', 'Affiliation': 'Department of Clinical Epidemiology and Public Health, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Martinez', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hernandez', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Targarona', 'Affiliation': 'Department of Surgery, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}]",The British journal of surgery,['10.1002/bjs.11389']
3299,32062677,Impact of postoperative instructions on physical activity following pelvic reconstructive surgery: a randomized controlled trial.,"INTRODUCTION AND HYPOTHESIS
There is little information on the impact that postoperative instructions have on physical activity to help guide physicians in providing these recommendations after surgery. Our study objective was to evaluate the impact of postoperative instructions on physical activity. We hypothesized that there would be no differential effect of instructions on activity.
METHODS
In this randomized controlled trial, patients undergoing prolapse repair were randomized to receive either liberal or restricted postoperative activity instructions between February 2017 and February 2019. Physical activity was measured using the Activities Assessment Scale (AAS) and tri-axial accelerometers measured at baseline and 2 and 6 weeks after surgery. A sample size of 146 patients was planned to compare these activity measurements. AAS scores and accelerometer readings of the two groups were compared using separate variance t tests.
RESULTS
A total of 157 women were recruited between February 2017 and February 2019, including 146 patients with completed study data (n = 72 liberal, n = 74 restricted). There was no difference in physical activity at 2 weeks between the liberal and the restricted instruction groups, as measured by AAS scores (70.47 ± 12.83, 69.54 ± 12.22, p = 0.66), total steps (4,582.20 ± 2,164.5, 5,014.47 ± 3,025.46, p = 0.32), active minutes (4.22 ± 6.17, 4.96 ± 9.65, p = 0.25), and 10-min intervals (0.76 ± 1.11, 0.77 ± 0.93, p = 0.95) respectively. Similarly, there was no difference in activity at 6 weeks between the liberal and the restricted instruction groups. as measured by AAS scores (81.86 ± 8.25, 81.31 ± 10.31, p = 0.72), total steps (6,316.25 ± 3,173.53, 6,589.94 ± 3,826.43, p = 0.64), active minutes (8.79 ± 10.5,11.36 ± 18.18, p = 0.98), and 10-min intervals (1.37 ± 1.34, 1.34 ± 1.40, p = 0.89) respectively.
CONCLUSION
Postoperative instructions do not have an impact on physical activity measures in patients who have undergone pelvic reconstructive surgery.",2020,"There was no difference in physical activity at 2 weeks between the liberal and the restricted instruction groups, as measured by AAS scores (70.47 ± 12.83, 69.54 ± 12.22, p = 0.66), total steps (4,582.20 ± 2,164.5, 5,014.47 ± 3,025.46, p = 0.32), active minutes (4.22 ± 6.17, 4.96 ± 9.65, p = 0.25), and 10-min intervals (0.76 ± 1.11, 0.77 ± 0.93, p = 0.95) respectively.","['pelvic reconstructive surgery', '146 patients', 'patients undergoing prolapse repair', 'A total of 157 women were recruited between February 2017 and February 2019, including 146 patients with completed study data (n\xa0=\u200972 liberal, n\xa0=\u200974 restricted', 'patients who have undergone pelvic reconstructive surgery']","['liberal or restricted postoperative activity instructions', 'postoperative instructions']","['physical activity', 'total steps', 'activity', 'AAS scores and accelerometer readings', 'physical activity measures', 'Activities Assessment Scale (AAS) and tri-axial accelerometers', 'AAS scores', 'Physical activity']","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856413', 'cui_str': 'Prolapse repair'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0205131', 'cui_str': 'Axial (qualifier value)'}]",157.0,0.286073,"There was no difference in physical activity at 2 weeks between the liberal and the restricted instruction groups, as measured by AAS scores (70.47 ± 12.83, 69.54 ± 12.22, p = 0.66), total steps (4,582.20 ± 2,164.5, 5,014.47 ± 3,025.46, p = 0.32), active minutes (4.22 ± 6.17, 4.96 ± 9.65, p = 0.25), and 10-min intervals (0.76 ± 1.11, 0.77 ± 0.93, p = 0.95) respectively.","[{'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Arunachalam', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Indiana University, 11725 N. Illinois Street, Suite K140, Carmel, IN, 46032, USA. divya.arunachalam77@gmail.com.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Heit', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Indiana University, 11725 N. Illinois Street, Suite K140, Carmel, IN, 46032, USA.'}]",International urogynecology journal,['10.1007/s00192-020-04239-y']
3300,30859320,Paraspinal muscle function and pain sensitivity following exercise-induced delayed-onset muscle soreness.,"PURPOSE
The aim of this study was to evaluate the effectiveness of an exercise protocol designed to induce delayed-onset muscle soreness (DOMS) in paraspinal muscles and its effects on low back functional capacities.
METHODS
Twenty-four healthy participants were asked to perform four series of 25 trunk flexion-extension in a prone position (45° inclined Roman chair). The protocol was performed using loads corresponding to participant's trunk weight plus 10% of their trunk extension maximal voluntary contraction. Perceived soreness and pain were assessed using an 11-point numerical analogue scale three times a day during 5 day post-DOMS protocol. Pressure-pain thresholds (PPT) in paraspinal muscles (L2 and L4 bilaterally) and the vastus medialis (control site), and trunk extension maximal voluntary contraction were assessed 24-36 h post-protocol and compared to baseline (t tests).
RESULTS
Muscle soreness (3.8/10) and pain (2.1/10) peak scores were observed 24-36 h post-protocol (mean of 28 h). A significant reduction in trunk extension maximal voluntary contraction was observed post-protocol (p = 0.005). Significant reductions in PPT were observed post-protocol for all trunk extensor sites (ps < 0.01), but not for the control site (p = 0.40).
CONCLUSIONS
The exercise protocol efficiently led to low back muscle DOMS, reduced functional capacities, and increased pain sensitivity locally. Such protocol could be used as an efficient and safe experimental low back pain model.",2019,"Significant reductions in PPT were observed post-protocol for all trunk extensor sites (ps < 0.01), but not for the control site (p = 0.40).
",['Twenty-four healthy participants'],"['exercise-induced delayed-onset muscle soreness', 'exercise protocol', '25 trunk flexion-extension in a prone position (45° inclined Roman chair']","['Muscle soreness', 'Perceived soreness and pain', 'Paraspinal muscle function and pain sensitivity', 'peak scores', 'trunk extension maximal voluntary contraction', 'Pressure-pain thresholds (PPT) in paraspinal muscles (L2 and L4 bilaterally) and the vastus medialis (control site), and trunk extension maximal voluntary contraction', 'PPT', 'pain sensitivity locally']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0033422', 'cui_str': 'Prone Position'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0448353', 'cui_str': 'Deep Muscles of the Back'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",24.0,0.115602,"Significant reductions in PPT were observed post-protocol for all trunk extensor sites (ps < 0.01), but not for the control site (p = 0.40).
","[{'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Abboud', 'Affiliation': ""Département d'Anatomie, Université du Québec à Trois-Rivières, 3351, boul. des Forges, C.P. 500, Trois-Rivières, QC, G9A 5H7, Canada. jacques.abboud@uqtr.ca.""}, {'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'Lessard', 'Affiliation': ""Département des Sciences de l'Activité Physique, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.""}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Piché', 'Affiliation': 'Département de Chiropratique, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Descarreaux', 'Affiliation': ""Département des Sciences de l'Activité Physique, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.""}]",European journal of applied physiology,['10.1007/s00421-019-04117-6']
3301,31698478,"Short-Term Effects of Growth Hormone on Lipolysis, Glucose and Amino Acid Metabolism Assessed in Serum and Microdialysate of Healthy Young Men.","OBJECTIVE
We investigated direct effects of a therapeutic growth hormone dose on lipolysis, glucose and amino acid metabolism.
METHODS
This crossover microdialysis trial involved six healthy male volunteers receiving single subcutaneous injections of both growth hormone (0.035 mg/kg) and placebo (0.9% sodium chloride). The investigation comprised three test days with standard diet. The first day served for adaptation, the second and third one for determining study data during 9 night hours with or without growth hormone. Abdominal subcutaneous microdialysate and blood were continuously collected and forwarded to a separate room next door where hourly taken samples were centrifuged and frozen until analysed.
RESULTS
Growth hormone achieved the peak serum level after 3 h followed by a plateau-like course for the next 6 h. Glycerol in microdialysate started to rise 2 h following growth hormone injection achieving significance compared to placebo after 9 h ( P <0.05). Serum glycerol increased 4 h after growth hormone administration achieving significance after 6 h ( P <0.05). Glucose and amino acid concentrations showed neither in microdialysate nor in serum significant differences between growth hormone and placebo. Serum values of insulin and C-peptide revealed no significant difference between growth hormone and placebo.
SUMMARY AND CONCLUSION
As the result of a high single subcutaneous dose of GH, persistent lipolysis can be shown in continuously collected microdialysate and blood, but no indication for gluconeogenesis or protein anabolism.",2020,"Serum values of insulin and C-peptide revealed no significant difference between growth hormone and placebo.
","['six healthy male volunteers receiving', 'Healthy Young Men']","['placebo', 'single subcutaneous injections of both growth hormone', 'Growth Hormone', 'placebo (0.9% sodium chloride']","['lipolysis, glucose and amino acid metabolism', 'peak serum level', 'Serum glycerol', 'Glucose and amino acid concentrations', 'Serum values of insulin and C-peptide', 'Lipolysis, Glucose and Amino Acid Metabolism']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}]",6.0,0.0615083,"Serum values of insulin and C-peptide revealed no significant difference between growth hormone and placebo.
","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Krebs', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Baum', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Doerfer', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gempel', 'Affiliation': 'Department of Clinical Chemistry, München Klinik Schwabing, München, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wurm', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Brichta', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Jörn Oliver', 'Initials': 'JO', 'LastName': 'Sass', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Winkler', 'Affiliation': 'Department of Clinical Chemistry, Faculty of Medicine, University of Freiburg, Germany.'}, {'ForeName': 'Karl Otfried', 'Initials': 'KO', 'LastName': 'Schwab', 'Affiliation': 'Department of Pediatrics and Adolescence Medicine, Faculty of Medicine, University of Freiburg, Germany.'}]","Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association",['10.1055/a-1027-6620']
3302,31729895,"The Influence of Sexual Arousal on Self-Reported Sexual Willingness and Automatic Approach to Models of Low, Medium, and High Prior Attractiveness.","Anecdotal evidence suggests that sexual attraction is flexible, and that high levels of sexual arousal can promote sexual willingness and approach tendencies toward a priori low attractive mates. This experimental study tested whether heightened sexual arousal can lower the threshold for sexual willingness and automatic approach tendencies toward potential sex partners of low and medium attractiveness. Heterosexual male ( n = 54) and female ( n = 61) participants were randomly assigned to a sexual arousal or control condition. Approach tendencies were indexed using a reaction time task. Sexual willingness was indexed using participant ratings of willingness to kiss and to consider having sex with same- and other-sex models of low, medium, and high attractiveness. Overall, participants showed stronger approach to models of high and medium than of low attractiveness. Sexual arousal weakened this differential responding but did not result in a robust increase of approach toward less attractive other-sex or same-sex models. Sexual willingness toward less attractive models was not affected by sexual arousal. Independent of condition, women reported greater sexual willingness toward same-sex models. The current pattern of findings does not support the notion that sexual arousal promotes automatic approach and sexual willingness to a broader array of sex partners.",2020,Sexual arousal weakened this differential responding but did not result in a robust increase of approach toward less attractive other-sex or same-sex models.,['Heterosexual male ( n = 54) and female ( n = 61'],['sexual arousal or control condition'],"['Sexual willingness', 'sexual willingness', 'Sexual arousal']","[{'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0233972', 'cui_str': 'Sexual excitation, function (observable entity)'}]",,0.018785,Sexual arousal weakened this differential responding but did not result in a robust increase of approach toward less attractive other-sex or same-sex models.,"[{'ForeName': 'Charmaine', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Pawłowska', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'van Stokkum', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}, {'ForeName': 'Janniko R', 'Initials': 'JR', 'LastName': 'Georgiadis', 'Affiliation': 'Department of Biomedical Sciences of Cells & Systems / Section Anatomy & Medical Physiology, University of Groningen, University Medical Center Groningen.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'de Jong', 'Affiliation': 'Department of Clinical Psychology & Experimental Psychopathology, University of Groningen.'}]",Journal of sex research,['10.1080/00224499.2019.1687641']
3303,31838056,Consumer responses to framing statements preceding the major risk statement in prescription drug DTC TV ads.,"BACKGROUND
Research on the major risk statement in direct-to-consumer (DTC) prescription drug television ads has shown that risk severity and actionability can affect consumers' risk comprehension and perceptions. A framing statement presented just before the major risk statement may serve as a cue that directs attention to the risk statement that follows, or it may guide consumers' interpretation of the severity of the risks that follow.
OBJECTIVE
Examine how the use of different framing statements (severe, life-threatening; serious; or basic) that precede the major risk statement in DTC television ads affect consumers' risk perceptions, risk recognition, benefit perceptions, interest in the drug, and other relevant outcomes.
METHODS
An online experiment was conducted using a 1 × 3 between-subjects design to compare three different framing statements, which was replicated across three different DTC television ads that focused on different medical conditions (arthritis, lung cancer, and type 2 diabetes). A sample of US adults (N = 1961) was randomly assigned to view one of nine television ads and asked to respond to a questionnaire.
RESULTS
The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits.
CONCLUSIONS
Consumers pay attention to and use cues to process and interpret the risk information presented to them in DTC television ads. Using lead-in language that describes risk severity, particularly for products with severe, life-threatening risks, may better allow consumers to make evaluative judgments on risk severity in DTC ads than stating the drug can cause serious reactions or simply that reactions are possible. More work is needed to examine the factors that affect people's understanding of the nature of risk severity, particularly with regard to risk recognition.",2020,"The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits.
",['A sample of US adults (N\xa0=\xa01961'],['nine television ads and asked to respond to a questionnaire'],"['perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0265402,"The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits.
","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA. Electronic address: kathryn.aikin@fda.hhs.gov.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Betts', 'Affiliation': 'US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA. Electronic address: kevin.betts@fda.hhs.gov.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Boudewyns', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC, 27709, USA. Electronic address: vboudewyns@rti.org.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC, 27709, USA. Electronic address: mjohnson@rti.org.'}, {'ForeName': 'Christine N', 'Initials': 'CN', 'LastName': 'Davis', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC, 27709, USA. Electronic address: cdavis@rti.org.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.11.018']
3304,31613129,Family-centered alcohol use prevention for African American adolescents: A randomized clinical trial.,"OBJECTIVE
The efficacy of the Strong African American Families (SAAF) alcohol use prevention program was tested. SAAF is a 7-session family skills training program offered in community settings. To overcome limitations of a past trial that used intent-to-treat (ITT) analyses, a Complier Average Causal Effect (CACE) analysis was used to estimate intervention effects and to determine the precise dosage of the intervention needed to achieve alcohol deterrence.
METHOD
A sample of 472 African American youth and their caregivers were recruited randomly from public schools in 7 rural Georgia counties. Families were assigned randomly to receive SAAF or a no-treatment control. Youth provided data on their alcohol use during the past 3 months at 4 home visits, the final occurring 34 months after baseline and 28 months after the intervention.
RESULTS
Efficacy was tested with Poisson latent growth curve models. SAAF deterred growth in alcohol use in models using both ITT and CACE estimation. CACE analyses revealed that, among participants who received a full dose of the intervention (7 sessions), a large treatment effect on slowed growth in alcohol use emerged (β = -.83, p < .001). Dose-response analyses in CACE models revealed a medium-sized effect (d [95% CI] = 1.51 [1.25, 1.75]) when participants attended at least 5 of the 7 sessions offered.
CONCLUSIONS
Replication of SAAF in a second randomized prevention trial supports the robustness of program effects. It is critical, however, that participant engagement protocols be designed to encourage participation in as at least 5 of the 7 sessions. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,SAAF deterred growth in alcohol use in models using both ITT and CACE estimation.,"['African American adolescents', '472 African American youth and their caregivers were recruited randomly from public schools in 7 rural Georgia counties']","['SAAF', 'Family-centered alcohol use prevention', 'SAAF or a no-treatment control']",[],"[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],2019.0,0.0344892,SAAF deterred growth in alcohol use in models using both ITT and CACE estimation.,"[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kogan', 'Affiliation': 'Department of Human Development and Family Science, University of Georgia.'}, {'ForeName': 'Dayoung', 'Initials': 'D', 'LastName': 'Bae', 'Affiliation': 'Center for Family Research, University of Georgia.'}, {'ForeName': 'Man-Kit', 'Initials': 'MK', 'LastName': 'Lei', 'Affiliation': 'Center for Family Research, University of Georgia.'}, {'ForeName': 'Gene H', 'Initials': 'GH', 'LastName': 'Brody', 'Affiliation': 'Center for Family Research, University of Georgia.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000448']
3305,31102525,Visit-to-visit variability in blood pressure and the development of chronic kidney disease in treated general hypertensive patients.,"BACKGROUND
Data on the association between visit-to-visit variability (VVV) in blood pressure (BP) and the risk of chronic kidney disease (CKD) in general treated hypertensive patients were limited. We aimed to evaluate the relation of VVV in BP with the development of CKD, and examine any possible effect modifiers in hypertensive patients without prior cardiovascular diseases (CVDs) or CKD.
METHODS
This is a post hoc analysis of the Renal Sub-study of the China Stroke Primary Prevention Trial (CSPPT). A total of 10 051 hypertensives without CVD and CKD and with at least six visits of BP measurements from randomization to the 24-month visit were included. The main VVV in BP was expressed as standard deviation (SD). The primary outcome was the development of CKD, defined as a decrease in estimated glomerular filtration rate ≥30% and to a level of <60 mL/min/1.73 m2, or end-stage renal disease.
RESULTS
The median treatment duration was 4.4 years. After multivariable adjustment, including baseline systolic blood pressure (SBP) and mean SBP during the first 2-year treatment period, there was a significantly positive relationship of SD of SBP with the risk of CKD development (per SD increment; odds ratio, 1.27; 95% confidence interval: 1.10-1.46). The results were similar for coefficient of variation (CV) of SBP. Results across various subgroups, including age, sex, SBP at baseline, treatment compliance, concomitant antihypertensive medications and mean SBP during the first 24-month treatment period, were consistent.
CONCLUSIONS
SBP variability, irrespective of mean BP level, was significantly associated with the development of CKD in general treated hypertensive patients.",2020,"CONCLUSIONS
SBP variability, irrespective of mean BP level, was significantly associated with the development of CKD in general treated hypertensive patients.","['A total of 10\xa0051 hypertensives without CVD and CKD and with at least six visits of BP measurements from randomization to the 24-month visit were included', 'general treated hypertensive patients', 'treated general hypertensive patients', 'hypertensive patients without prior cardiovascular diseases (CVDs) or CKD']",[],"['coefficient of variation (CV) of SBP', 'SD of SBP with the risk of CKD development', 'baseline systolic blood pressure (SBP) and mean SBP', 'mean BP level', 'blood pressure (BP', 'median treatment duration', 'development of CKD, defined as a decrease in estimated glomerular filtration rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",[],"[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C3811844'}]",10051.0,0.0580914,"CONCLUSIONS
SBP variability, irrespective of mean BP level, was significantly associated with the development of CKD in general treated hypertensive patients.","[{'ForeName': 'Youbao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Beijing Advanced Innovation Center for Food Nutrition and Human Health, The Key Laboratory for Functional Dairy, College of Food Science and Nutritional Engineering, China Agricultural University, Beijing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Fangfang', 'Initials': 'F', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Guobao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': 'Department of Cardiology, Second Affiliated Hospital, Nanchang University, Nanchang, China.'}, {'ForeName': 'Ningling', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""Department of Cardiology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Yingxian', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Cardiology, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Lianyou', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Cardiology, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Qijun', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': ""Department of Nephrology, Shenzhen Second People's Hospital, Shenzhen, China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Emergency, First People's Hospital of Lianyungang, Lianyungang, China.""}, {'ForeName': 'Junnong', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Weinan Central Hospital, Weinan, China.'}, {'ForeName': 'Qinghua', 'Initials': 'Q', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, The First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Division of Nephrology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz093']
3306,31740723,Oxytocin reduces the functional connectivity between brain regions involved in eating behavior in men with overweight and obesity.,"BACKGROUND
Oxytocin (OXT), shown to decrease food intake in animal models and men, is a promising novel treatment for obesity. We have shown that in men with overweight and obesity, intranasal (IN) OXT reduced the functional magnetic resonance imaging (fMRI) blood oxygenation level-dependent signal in the ventral tegmental area (VTA), the origin of the mesolimbic dopaminergic reward system, in response to high-calorie food vs. nonfood images. Here, we employed functional connectivity fMRI analysis, which measures the synchrony in activation between neural systems in a context-dependent manner. We hypothesized that OXT would attenuate the functional connectivity of the VTA with key food motivation brain areas only when participants viewed high-calorie food stimuli.
METHODS
This randomized, double-blind, and placebo-controlled crossover study of 24 IU IN OXT included ten men with overweight or obesity (mean ± SEM BMI: 28.9 ± 0.8 kg/m 2 ). Following drug administration, subjects completed an fMRI food motivation paradigm including images of high and low-calorie foods, nonfood objects, and fixation stimuli. A psychophysiological interaction analysis was performed with the VTA as seed region.
RESULTS
Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05). There was no difference in functional connectivity between VTA and these brain areas when comparing OXT and placebo for low-calorie food, nonfood, and fixation images.
CONCLUSION
In men with overweight and obesity, OXT attenuates the functional connectivity between the VTA and food motivation brain regions in response to high-calorie visual food images. These findings could partially explain the observed anorexigenic effect of OXT, providing insight into the mechanism through which OXT ameliorates food cue-induced reward anticipation in patients with obesity. Additional studies are ongoing to further delineate the anorexigenic effect of OXT in obesity.",2020,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","['men with overweight and obesity', 'ten men with overweight or obesity (mean\u2009±\u2009SEM BMI: 28.9\u2009±\u20090.8\u2009kg/m 2 ', 'men with overweight and obesity, intranasal (IN', 'patients with obesity']","['OXT', '24 IU IN OXT', 'placebo', 'Oxytocin', 'OXT and placebo', 'Oxytocin (OXT']","['insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods', 'functional connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0037658', 'cui_str': 'Somatosensory Cortex'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0949582', 'cui_str': 'Seahorses'}, {'cui': 'C0228262', 'cui_str': 'Operculum structure'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0453831', 'cui_str': 'High energy food (substance)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.191194,"Following OXT administration, compared with placebo, participants exhibited significantly attenuated functional connectivity between the VTA and the insula, oral somatosensory cortex, amygdala, hippocampus, operculum, and middle temporal gyrus in response to viewing high-calorie foods (Z ≥ 3.1, cluster-corrected, p < 0.05).","[{'ForeName': 'Liya', 'Initials': 'L', 'LastName': 'Kerem', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nouchine', 'Initials': 'N', 'LastName': 'Hadjikhani', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Holsen', 'Affiliation': ""Division of Women's Health, Department of Medicine and Department of Psychiatry, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Lawson', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. ealawson@partners.org.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Plessow', 'Affiliation': 'Neuroendocrine Unit, Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. fplessow@mgh.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-019-0489-7']
3307,31746443,Intramedullary Nailing and Minimally Invasive Percutaneous Plate Osteosynthesis in Treatment of Displaced Clavicular Mid-shaft Fractures: A Prospective Study.,"OBJECTIVE
To compare the difference between MIPO and IMN methods in the treatment of displaced clavicular mid-shaft fractures.
METHODS
A total 163 patients were consecutively enrolled and randomly divided into the MIPO group or the IMN group. Clinical characteristics and outcomes including age, gender, causes of fractures, and AO/OTA type as well as hospitalization time, healing time, and postoperative complications were analyzed. Constant-Murley scores and DASH scores were used for assessment of shoulder joint and upper extremity function, respectively.
RESULTS
In this study, 82 cases received MIPO and 81 cases received IMN. The mean operation time, mean bleeding volume, mean hospitalization time, and mean healing time showed no significant difference between the MIPO and IMN groups. At 3 months after surgery, Constant-Murley scores were significantly higher and DASH scores were significantly lower in the MIPO group than the IMN group. No significant difference was observed for both indexes at 6 months. The fracture nonunion rate was significantly lower in the MIPO group. No significant difference was found in other complications.
CONCLUSION
Both methods were effective for the treatment of displaced clavicular mid-shaft fractures. However, the MIPO method might be better for recovery of shoulder and upper extremity function in the short term and might have a lower nonunion rate.",2020,"The mean operation time, mean bleeding volume, mean hospitalization time, and mean healing time showed no significant difference between the MIPO and IMN groups.","['displaced clavicular mid-shaft fractures', 'A total 163 patients', 'Displaced Clavicular Mid-shaft Fractures', '82 cases received MIPO and 81 cases received']","['MIPO', 'Intramedullary Nailing and Minimally Invasive Percutaneous Plate Osteosynthesis', 'IMN']","['fracture nonunion rate', 'mean operation time, mean bleeding volume, mean hospitalization time, and mean healing time', 'Constant-Murley scores and DASH scores', 'complications', 'DASH scores', 'Constant-Murley scores', 'recovery of shoulder and upper extremity function', 'hospitalization time, healing time, and postoperative complications']","[{'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0337141', 'cui_str': 'Shaft (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]","[{'cui': 'C0016665', 'cui_str': 'Fractures, Ununited'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",163.0,0.0141324,"The mean operation time, mean bleeding volume, mean hospitalization time, and mean healing time showed no significant difference between the MIPO and IMN groups.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, Zhejiang Hospital, Hangzhou, Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopedics, People's Liberation Army 903 Hospital, Hangzhou, Zhejiang Province, Hangzhou, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopedics, People's Liberation Army 903 Hospital, Hangzhou, Zhejiang Province, Hangzhou, China.""}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopedics, Zhejiang Hospital, Hangzhou, Zhejiang Province, Hangzhou, China.'}]",Zeitschrift fur Orthopadie und Unfallchirurgie,['10.1055/a-1008-9943']
3308,31842191,ROBOT-ASSISTED VITREORETINAL SURGERY IMPROVES SURGICAL ACCURACY COMPARED WITH MANUAL SURGERY: A Randomized Trial in a Simulated Setting.,"PURPOSE
To compare manual and robot-assisted vitreoretinal surgery using a virtual-reality surgical simulator.
METHODS
Randomized controlled crossover study. Ten experienced vitreoretinal surgeons and 10 novice ophthalmic surgeons were included. The participants were randomized to start with either manual or robot-assisted surgery. Participants completed a test session consisting of three vitreoretinal modules on the Eyesi virtual-reality simulator. The automated metrics of performance supplied by the Eyesi simulator were used as outcome measures. Primary outcome measures were time with instruments inserted (seconds), instrument movement (mm), and tissue treatment (mm).
RESULTS
Robot-assisted surgery was slower than manual surgery for both novices and vitreoretinal surgeons, 0.24 SD units (P = 0.024) and 0.73 SD units (P < 0.001), respectively. Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively. Finally, novices using robot-assisted surgery inflicted less tissue damage when compared with that using manual surgery, -0.59 SD units (P = 0.009).
CONCLUSION
At the cost of time, robot-assisted vitreoretinal surgery seems to improve precision and limit tissue damage compared with that of manual surgery. In particular, the performance of novice surgeons is enhanced with robot-assisted vitreoretinal surgery.",2020,"Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively.",['Ten experienced vitreoretinal surgeons and 10 novice ophthalmic surgeons'],"['manual and robot-assisted vitreoretinal surgery', 'Robot-assisted surgery', 'robot-assisted vitreoretinal surgery', 'manual or robot-assisted surgery']","['time with instruments inserted (seconds), instrument movement (mm), and tissue treatment (mm', 'tissue damage', 'precision and limit tissue damage']","[{'cui': 'C1720040', 'cui_str': 'Vitreoretinal surgeon'}, {'cui': 'C0260073', 'cui_str': 'Ophthalmic surgeon (occupation)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2936205', 'cui_str': 'Vitreoretinal Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]",10.0,0.286633,"Robot-assisted surgery allowed for greater precision in novices and vitreoretinal surgeons, -0.96 SD units (P < 0.001) and -0.47 SD units (P < 0.001), respectively.","[{'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Forslund Jacobsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Konge', 'Affiliation': 'Copenhagen Academy for Medical Education and Simulation, Centre for HR, Capital Region of Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Alberti', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'la Cour', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}, {'ForeName': 'Yoon Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Medical Education, University of Illinois, Chicago, Illinois.'}, {'ForeName': 'Ann Sofia Skou', 'Initials': 'ASS', 'LastName': 'Thomsen', 'Affiliation': 'Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002720']
3309,29927273,How prescriptive support affects weight loss in weight-loss intervention participants and their untreated spouses.,"OBJECTIVE
Controlling or prescriptive support styles (e.g., pressure) often hinder weight loss, but can sometimes be beneficial. This secondary analysis of data from a randomized controlled trial examined persuasion, pressure, and indirect social control among cohabiting couples and the effect of these supports on weight loss.
METHODS
Couples ( N Couples = 130) were randomized to either Weight Watchers (WW) or a self-guided control condition (SG). Only one member of each couple received the intervention; the other member of the couple was untreated. Couples were weighed and completed study measures at baseline, 3, and 6 months.
RESULTS
Dyadic multilevel models examined BMI change and differences across role (treated participant/untreated spouse) and condition (WW/SG). Prescriptive support predicted BMI change for treated participants in the WW condition only. For treated WW participants, there was no significant decrease in BMI when pressure was high (+1 SD ), B = -.25, p = .22, but a significant decrease when pressure was low (0), B = -.96, p < .001. Additionally, high levels of indirect social control (+1 SD ) predicted greater decreases in BMI compared to low (-1 SD ) indirect social control, B = -.91, p < .001, and, B = -.41, p < .01.
CONCLUSIONS
Considering both the type and context of support for weight management is worthwhile. Intervention participants had access to treatment resources that may have engendered more effective responses to spouses' concerns or a sense of obligation to their spouse (indirect social control), whereas pressures to lose weight-while engaged in treatment-may have undermined behavior-change efforts. (PsycINFO Database Record",2018,"For treated WW participants, there was no significant decrease in BMI when pressure was high (+1 SD ), B = -.25, ","['weight-loss intervention participants and their untreated spouses', 'Couples ( N Couples = 130']",['Weight Watchers (WW) or a self-guided control condition (SG'],"['BMI', 'weight loss', 'BMI change', 'high levels of indirect social control']","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0162409', 'cui_str': 'Married Persons'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0037405', 'cui_str': 'Social Control'}]",130.0,0.0382028,"For treated WW participants, there was no significant decrease in BMI when pressure was high (+1 SD ), B = -.25, ","[{'ForeName': 'Talea', 'Initials': 'T', 'LastName': 'Cornelius', 'Affiliation': 'Department of Medicine.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Gettens', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Lenz', 'Affiliation': 'Department of Psychological Sciences.'}, {'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'Wojtanowski', 'Affiliation': 'Weight Watchers International, Inc.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'Weight Watchers International, Inc.'}, {'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Gorin', 'Affiliation': 'Department of Psychological Sciences.'}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000630']
3310,31870658,Hip extensor fatigue alters hip and knee coupling dynamics during single-limb step-downs: A randomized controlled trial.,"Impaired hip muscle function may cause movement coordination deficits that increase lower extremity injury risks. We examined whether hip and knee coordination is altered during single-limb step-downs following a hip extensor fatigue protocol. Forty participants in this randomized controlled trial performed 20 single-limb step-downs before and after completing either a fatigue protocol or a sham fatigue protocol. Means and SDs of sagittal and frontal plane hip and knee kinematics were measured. Nonlinear measures of coupled hip and knee coordination were examined with cross recurrence quantification analyses. Pre- to post-fatigue change scores were analyzed inferentially (α = 0.05). The fatigue protocol induced 22.2% strength reduction in the fatigue group, versus 4% reduction in the sham group. Neither the magnitude nor variability in sagittal and frontal plane hip and knee kinematics changed following the fatigue protocol (P > .05, small effect sizes). Participants in the fatigue group, however, performed post-fatigue step-downs with greater cross determinism (P = .046, effect size = 0.71) and mean line (P = .038, effect size = 0.74) in sagittal plane hip and frontal plane knee coupling, whereas participants in the sham-control group performed step-downs with reductions in those measures. In the fatigued state, participants performed repeated step-downs with subtle increases in cross determinism and cross mean line, which implies they performed the task with greater predictability of hip and knee coupling and less adaptability. The findings may provide insight into coupled movement patterns and their reflection of motor control.",2020,"Neither the magnitude nor variability in sagittal and frontal plane hip and knee kinematics changed following the fatigue protocol (P > .05, small effect sizes).",['Forty participants'],"['20 single-limb step-downs before and after completing either a fatigue protocol or a sham fatigue protocol', 'single-limb step-downs']","['sagittal plane hip and frontal plane knee coupling', 'magnitude nor variability in sagittal and frontal plane hip and knee kinematics', 'Pre- to post-fatigue change scores', 'Means and SDs of sagittal and frontal plane hip and knee kinematics']",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205104', 'cui_str': 'Down (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0935598', 'cui_str': 'Sagittal plane'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C4551585', 'cui_str': 'Frontal plane'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",40.0,0.0499484,"Neither the magnitude nor variability in sagittal and frontal plane hip and knee kinematics changed following the fatigue protocol (P > .05, small effect sizes).","[{'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Hollman', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, MN, United States; Program in Physical Therapy, Mayo Clinic School of Health Sciences, Mayo Clinic College of Medicine and Science, Rochester, MN, United States. Electronic address: hollman.john@mayo.edu.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Beise', 'Affiliation': 'Program in Physical Therapy, Mayo Clinic School of Health Sciences, Mayo Clinic College of Medicine and Science, Rochester, MN, United States.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Fischer', 'Affiliation': 'Program in Physical Therapy, Mayo Clinic School of Health Sciences, Mayo Clinic College of Medicine and Science, Rochester, MN, United States.'}, {'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Stecklein', 'Affiliation': 'Program in Physical Therapy, Mayo Clinic School of Health Sciences, Mayo Clinic College of Medicine and Science, Rochester, MN, United States.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109583']
3311,31965646,Effects of a nutrient-dense formula compared with a post-discharge formula on post-discharge growth of preterm very low birth weight infants with extrauterine growth retardation: a multicentre randomised study in China.,"BACKGROUND
Post-discharge optimal growth and nutritional intake have beneficial effects for neurodevelopment in preterm very low birth weight infants (VLBWIs) with extrauterine growth retardation (EUGR). The present study aimed to compare the effects of a nutrient-dense formula (NDF) to a post-discharge formula (PDF) on post-discharge growth of preterm VLBWIs with EUGR.
METHODS
Forty-eight preterm VLBWIs with EUGR at discharge were randomised to receive NDF (100 kcal per 100 mL; 2.6 g protein per 100 mL) or PDF (74 kcal per 100 mL; 1.95 g protein per 100 mL) for 1-6 months until body weight reached the 50th percentile on growth charts with corrected age. Volume, nutrient intake, anthropometry and biochemistry data were collected.
RESULTS
Volume intake was lower in the NDF group than the PDF group during the first 2 months of feeding (P = 0.039 and 0.018, respectively).There were no significant differences in volume intake during months 2-6 of feeding. Energy, protein, carbohydrate and fat intake were higher in the NDF group during months 1-6 of feeding. There were no significant differences in weight, length, and head circumference Z-scores during months 1-6 between the two groups. The △length Z-score from discharge to month 6 was significantly higher in the NDF group than the PDF group (P = 0.043). No differences existed between the two groups with respect to biochemistry.
CONCLUSIONS
After discharge, preterm VLBWIs with EUGR fed a NDF gain anthropometric parameter Z-scores similar to those for a PDF within 6 months of follow-up. A NDF leading to gain in length requires further follow-up.",2020,"There were no significant differences in weight, length, and head circumference Z-scores during months 1-6 between the two groups.","['preterm very low birth weight infants with extrauterine growth retardation', 'Forty-eight preterm VLBWIs with EUGR at discharge', 'preterm very low birth weight infants (VLBWIs) with extrauterine growth retardation (EUGR']","['nutrient-dense formula compared with a post-discharge formula', 'PDF', 'nutrient-dense formula (NDF) to a post-discharge formula (PDF', 'NDF']","['volume intake', 'weight, length, and head circumference Z-scores', 'Volume intake', 'Volume, nutrient intake, anthropometry and biochemistry data', 'Energy, protein, carbohydrate and fat intake', '△length Z-score from discharge to month 6']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0151686', 'cui_str': 'Growth retardation (morphologic abnormality)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0262499', 'cui_str': 'Head circumference (observable entity)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0708289,"There were no significant differences in weight, length, and head circumference Z-scores during months 1-6 between the two groups.","[{'ForeName': 'M-X', 'Initials': 'MX', 'LastName': 'Yu', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangdong, China.'}, {'ForeName': 'S-Q', 'Initials': 'SQ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Pediatrics, The First Affiliated Hospital, Sun Yat-sen University, Guangdong, China.'}, {'ForeName': 'X-Y', 'Initials': 'XY', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology, The Maternal & Child Health Hospital of Guangxi Zhuang Autonomous Region, Guangxi, China.'}, {'ForeName': 'X-M', 'Initials': 'XM', 'LastName': 'Tong', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'S-J', 'Initials': 'SJ', 'LastName': 'Yue', 'Affiliation': 'Department of Neonatology, Xiangya Hospital Central South University, Hunan, China.'}, {'ForeName': 'L-P', 'Initials': 'LP', 'LastName': 'Shi', 'Affiliation': ""Department of Neonatology, The Chidlren's Hospital Zhejiang University School of Medicine, Zhejiang, China.""}, {'ForeName': 'D-M', 'Initials': 'DM', 'LastName': 'Chen', 'Affiliation': ""Department of Pediatrics, Quanzhou Women's and Children's Hospital, Fujian, China.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Liang', 'Affiliation': 'Department of Pediatrics, First Affiliated Hospital of Kunming Medical University, Yunnan, China.'}]",Journal of human nutrition and dietetics : the official journal of the British Dietetic Association,['10.1111/jhn.12733']
3312,31955429,Nutritional ketosis improves exercise metabolism in patients with very long-chain acyl-CoA dehydrogenase deficiency.,"A maladaptive shift from fat to carbohydrate (CHO) oxidation during exercise is thought to underlie myopathy and exercise-induced rhabdomyolysis in patients with fatty acid oxidation (FAO) disorders. We hypothesised that ingestion of a ketone ester (KE) drink prior to exercise could serve as an alternative oxidative substrate supply to boost muscular ATP homeostasis. To establish a rational basis for therapeutic use of KE supplementation in FAO, we tested this hypothesis in patients deficient in Very Long-Chain acyl-CoA Dehydrogenase (VLCAD). Five patients (range 17-45 y; 4 M/1F) patients were included in an investigator-initiated, randomised, blinded, placebo-controlled, 2-way cross-over study. Patients drank either a KE + CHO mix or an isocaloric CHO equivalent and performed 35 minutes upright cycling followed by 10 minutes supine cycling inside a Magnetic Resonance scanner at individual maximal FAO work rate (fatmax; approximately 40% VO 2 max). The protocol was repeated after a 1-week interval with the alternate drink. Primary outcome measures were quadriceps phosphocreatine (PCr), Pi and pH dynamics during exercise and recovery assayed by in vivo 31 P-MR spectroscopy. Secondary outcomes included plasma and muscle metabolites and respiratory gas exchange recordings. Ingestion of KE rapidly induced mild ketosis and increased muscle BHB content. During exercise at FATMAX, VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio were all lower in KE + CHO than CHO. These results provide a rational basis for future clinical trials of synthetic ketone ester supplementation therapy in patients with FAO disorders. Trial registration: ClinicalTrials.gov. Protocol ID: NCT03531554; METC2014.492; ABR51222.042.14.",2020,"During exercise at FATMAX, VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio were all lower in KE+CHO than CHO.
","['patients with fatty acid oxidation (FAO) disorders', 'patients deficient in Very Long-Chain acyl-CoA Dehydrogenase (VLCAD', 'Five patients (range 17-45 y; 4M/1F) patients', 'patients with very long-chain acyl-CoA dehydrogenase deficiency', 'patients with FAO disorders']","['placebo', 'ketone ester (KE) drink', 'synthetic ketone ester supplementation therapy', 'KE+CHO mix or an isocaloric CHO equivalent and performed 35 min upright cycling followed by 10 minutes supine cycling inside a Magnetic Resonance scanner', 'KE supplementation', 'Nutritional ketosis']","['exercise metabolism', 'plasma and muscle metabolites and respiratory gas exchange recordings', 'quadriceps phosphocreatine (PCr), Pi and pH dynamics during exercise and recovery assayed by in vivo 31 P-MR spectroscopy', 'VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio', 'mild ketosis and increased muscle BHB content']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456270', 'cui_str': 'Fatty acid oxidation disorder'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0065170', 'cui_str': 'Very-Long-Chain Acyl-CoA Dehydrogenase'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C3887523', 'cui_str': 'Acadvl'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022634', 'cui_str': 'Ketones'}, {'cui': 'C0014898', 'cui_str': 'Esters'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1735596', 'cui_str': 'Supplementation therapy'}, {'cui': 'C1720722', 'cui_str': 'Mix'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0024487', 'cui_str': 'MR Spectroscopy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0368608', 'cui_str': 'acylcarnitine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.165283,"During exercise at FATMAX, VLCADD-specific plasma acylcarnitine levels, quadriceps glycolytic intermediate levels and in vivo Pi/PCr ratio were all lower in KE+CHO than CHO.
","[{'ForeName': 'Jeannette C', 'Initials': 'JC', 'LastName': 'Bleeker', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Gepke', 'Initials': 'G', 'LastName': 'Visser', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Clarke', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Ferdinandusse', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ferdinand H', 'Initials': 'FH', 'LastName': 'de Haan', 'Affiliation': 'ACHIEVE, Center for Applied Research, Faculty of Health, University of Applied Sciences Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Riekelt H', 'Initials': 'RH', 'LastName': 'Houtkooper', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Lodewijk', 'Initials': 'L', 'LastName': 'IJlst', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Irene L', 'Initials': 'IL', 'LastName': 'Kok', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Langeveld', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W Ludo', 'Initials': 'WL', 'LastName': 'van der Pol', 'Affiliation': 'Department of Neurology and Neurosurgery, Rudolf Magnus Institute of Neuroscience, Spieren voor Spieren Kindercentrum, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Monique G M', 'Initials': 'MGM', 'LastName': 'de Sain-van der Velden', 'Affiliation': ""Department of Metabolic Diseases, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Sibeijn-Kuiper', 'Affiliation': 'Neuroimaging Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Takken', 'Affiliation': 'Center for Child Development & Exercise, Department of Medical Physiology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ronald J A', 'Initials': 'RJA', 'LastName': 'Wanders', 'Affiliation': ""Department of Metabolic Diseases, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'van Weeghel', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Frits A', 'Initials': 'FA', 'LastName': 'Wijburg', 'Affiliation': ""Department of Metabolic Diseases, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.""}, {'ForeName': 'Luc H', 'Initials': 'LH', 'LastName': 'van der Woude', 'Affiliation': 'Human Movement Sciences, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Rob C I', 'Initials': 'RCI', 'LastName': 'Wüst', 'Affiliation': 'Laboratory Genetic Metabolic Diseases, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pete J', 'Initials': 'PJ', 'LastName': 'Cox', 'Affiliation': 'Department of Physiology, Anatomy and Genetics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jeroen A L', 'Initials': 'JAL', 'LastName': 'Jeneson', 'Affiliation': 'Neuroimaging Center, Department of Biomedical Sciences of Cells and Systems, University Medical Center Groningen, Groningen, The Netherlands.'}]",Journal of inherited metabolic disease,['10.1002/jimd.12217']
3313,31912560,Non-technical skills curriculum incorporating simulation-based training improves performance in colonoscopy among novice endoscopists: Randomized controlled trial.,"BACKGROUND AND AIMS
Non-technical skills (NTS), involving cognitive, social and interpersonal skills that complement technical skills, are important for the completion of safe and efficient procedures. We investigated the impact of a simulation-based curriculum with dedicated NTS training on novice endoscopists' performance of clinical colonoscopies.
METHODS
A single-blinded randomized controlled trial was conducted at a single center. Novice endoscopists were randomized to a control curriculum or a NTS curriculum. The control curriculum involved a didactic session, virtual reality (VR) simulator colonoscopy training, and integrated scenario practice using a VR simulator, a standardized patient, and endoscopy nurse. Feedback and training were provided by experienced endoscopists. The NTS curriculum group received similar training that included a small-group session on NTS, feedback targeting NTS, and access to a self-reflective NTS checklist. The primary outcome was performance during two clinical colonoscopies, assessed using the Joint Advisory Group Direct Observation of Procedural Skills (JAG DOPS) tool.
RESULTS
Thirty-nine participants completed the study. The NTS group (n = 21) had superior clinical performance during their first (P < 0.001) and second clinical colonoscopies (P < .0.001), compared to the control group (n = 18). The NTS group performed significantly better on the VR simulator (P < 0.05) and in the integrated scenario (P < 0.05).
CONCLUSION
Our findings demonstrate that dedicated NTS training led to improved performance of clinical colonoscopies among novices.",2020,The NTS group performed significantly better on the VR simulator (P<0.05) and in the integrated scenario (P<0.05) CONCLUSION: Our findings demonstrate that dedicated NTS training led to improved performance of clinical colonoscopies among novices.,"['Novice endoscopists', 'Thirty-nine participants completed the study', 'novice endoscopists']","['didactic session, virtual reality (VR) simulator colonoscopy training, and integrated scenario practice using a VR simulator, a standardized patient, and endoscopy nurse', 'similar training that included a small-group session on NTS, feedback targeting NTS, and access to a self-reflective NTS checklist', 'NTS', 'NTS training', 'simulation-based curriculum with dedicated NTS training', 'control curriculum or a NTS curriculum ']","['performance during two clinical colonoscopies, assessed using the Joint Advisory Group Direct Observation of Procedural Skills (JAG DOPS) tool', 'superior clinical performance']","[{'cui': 'C3816447', 'cui_str': '39 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}]",39.0,0.117725,The NTS group performed significantly better on the VR simulator (P<0.05) and in the integrated scenario (P<0.05) CONCLUSION: Our findings demonstrate that dedicated NTS training led to improved performance of clinical colonoscopies among novices.,"[{'ForeName': 'Catharine M', 'Initials': 'CM', 'LastName': 'Walsh', 'Affiliation': 'Division of Gastroenterology, Hepatology, and Nutrition, Learning Institute and Research Institute, Hospital for Sick Children, Toronto, Canada.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Scaffidi', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Rishad', 'Initials': 'R', 'LastName': 'Khan', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Arora', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Nikko', 'Initials': 'N', 'LastName': 'Gimpaya', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Satchwell', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Al-Mazroui', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Zarghom', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Suraj', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Alya', 'Initials': 'A', 'LastName': 'Kamani', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Genis', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Kalaichandran', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Samir C', 'Initials': 'SC', 'LastName': 'Grover', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of Toronto, Toronto, Canada.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13623']
3314,31985173,Sexism Interacts with Patient-Physician Gender Concordance in Influencing Patient Control Preferences: Findings from a Vignette Experimental Design.,"BACKGROUND
Patient preferences regarding their involvement in shared treatments decisions is fundamental in clinical practice. Previous evidences demonstrated a large heterogeneity in these preferences. However, only few studies have analysed the influence of patients' individual differences, contextual and situational qualities, and their complex interaction in explaining this variability.
METHODS
We assessed the role of the interaction of patient's sociodemographic and psychological factors with a physician's gender. Specifically, we focused on patient gender and attitudes toward male or female physicians. One hundred fifty-three people participated in this randomised controlled study and were randomly assigned to one of two experimental conditions in which they were asked to imagine discussing their treatment with a male and a female doctor.
RESULTS
Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences.
CONCLUSIONS
In conclusion, patients' attitudes toward the physicians' gender constitutes a relevant characteristic that may influence the degree of control patients want to have and the overall patient-physician relationship.",2020,"RESULTS
Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences.
","['patient gender and attitudes toward male or female physicians', 'One hundred fifty-three people participated', 'Patient Control Preferences']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",[],[],153.0,0.0465349,"RESULTS
Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences.
","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Monzani', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vergani', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia Francesca Maria', 'Initials': 'SFM', 'LastName': 'Pizzoli', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Marton', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Ketti', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bailo', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Messori', 'Affiliation': 'Department of Oncology and Hemato-oncology, University of Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pancani', 'Affiliation': 'Department of Psychology, University of Milan - Bicocca, Milan, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Cattelan', 'Affiliation': 'Department of Statistical Sciences, University of Padova, Padova, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12193']